CN111278498A

CN111278498A - Ureteral and bladder catheters and methods of introducing negative pressure to increase renal perfusion

Info

Publication number: CN111278498A
Application number: CN201880069239.0A
Authority: CN
Inventors: 约翰·R·厄尔贝二世; 大卫·E·奥尔; 雅各布·L·厄珀可; 兰斯·迈克尔·布莱克; 迈克尔·艾伦·菲舍尔; 帕特里克·威廉·斯特兰
Original assignee: Strataka Systems Ltd
Current assignee: Rovios Ltd.
Priority date: 2017-08-25
Filing date: 2018-08-24
Publication date: 2020-06-12
Also published as: EP3672678A1; BR112020003829A2; MX2020002065A; WO2019038734A1; JP2020531149A; CA3073907A1

Abstract

The invention provides a method for promoting kidney urination, which comprises the following steps: (a) inserting a drainage lumen having a distal portion and a proximal portion, the distal portion being located in a kidney, a renal pelvis, and/or a ureter proximate to the renal pelvis of a patient, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being smaller than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a period of time to promote renal urination.

Description

Ureteral and bladder catheters and methods of introducing negative pressure to increase renal perfusion

Cross Reference to Related Applications

The present application claims priority from U.S. patent application 15/687,064 filed on 25.8.2017, U.S. patent application 15/687,064 is a partial continuation of U.S. patent application 15/411,884 filed on 20.1.2017, U.S. patent application 15/411,884 is a partial continuation of U.S. patent application 15/214,955 filed on 20.7.2016, U.S. patent application 15/214,955 claims the benefit of U.S. provisional application 62/300,025 filed on 25.2.2016, U.S. provisional application 62/278,721 filed on 14.1.2016, U.S. provisional application 62/260,966 filed on 30.11.2015, and U.S. provisional application 62/194,585 filed on 20.7.2015, each of which is incorporated herein by reference in its entirety.

Background

Technical Field

The present invention relates to methods and devices for treating impaired renal function in various conditions, in particular catheter devices, assemblies and methods for collecting urine and/or introducing negative pressure in the kidney, the renal pelvis and/or ureter of the kidney.

Background

The renal system or urinary system includes a pair of kidneys, each of which is connected to the bladder through a ureter, and a urethra for discharging urine produced by the kidneys from the bladder. The kidneys have a number of important functions for the human body, such as filtering blood to discharge waste in the form of urine. The kidney also regulates electrolytes (e.g., sodium, potassium, and calcium) and metabolites, blood volume, blood pressure, blood pH, fluid volume, erythropoiesis, and bone metabolism. A full understanding of the anatomy and physiological condition of the kidney helps to understand the effect of other fluid overload conditions that alter hemodynamic conditions on its function.

In normal anatomy, two kidneys are located retroperitoneally of the abdominal cavity. The kidney is a bean-like, enveloped organ. Urine is formed by the nephron (the functional unit of the kidney) and then flows through a system of converging tubules called the collecting duct. The manifolds join together to form a small calyx, then a large calyx, which eventually meets near the renal fossa (renal pelvis). The primary function of the renal pelvis is to direct the flow of urine into the ureters. Urine flows from the renal pelvis into the ureter, a tubular structure that transports urine from the kidney to the bladder. The outer layer of the kidney, called the cortex, is a hard fibrous coating. The interior of the kidney is called the medulla, and these medullary structures are arranged in a pyramidal fashion.

Each kidney consists of about one million nephrons. A schematic of nephron 1102 is shown in FIG. 39. Each nephron includes a glomerulus 1110, a renal capsule 1112, and a renal tubule 1114. The renal tubules include proximal convoluted tubule 1116, henle ring 1118, distal convoluted tubule 1120, and collection duct 1122. Nephrons 1102 in the renal cortex have different anatomical structures than nephrons in the medulla, the main difference being the length of henna ring 1118. The loop of the medullary nephron is longer and normally regulates water and sodium reabsorption to a greater extent than does the cortical nephron.

The glomerulus is the beginning of the nephron and is responsible for the initial filtration of blood. The small afferent artery transports blood into the glomerular capillaries where hydrostatic pressure pushes water and solutes into the renal capsule. The net filtration pressure is equal to the hydrostatic pressure in the entering arteriole minus the hydrostatic pressure in the renal capsule cavity minus the osmotic pressure in the exiting arteriole:

net filtration pressure ═ hydrostatic pressure (entering spheriodal arteriole) -hydrostatic pressure (renal vesicle cavity) -osmotic pressure (exiting spheriodal arteriole) (equation 1)

The magnitude of the net filtration pressure determined by equation 1 determines the amount of ultrafiltration fluid that is formed in the renal capsule lumen and delivered to the renal tubules. The remaining blood flows out of the glomerulus through the efferent arteriole. Normal glomerular filtration or ultrafiltrate is delivered to the tubules at a rate of about 90mL/min/1.73m²。

The glomeruli have a three-layer filtration structure including vascular endothelial cells, glomerular basement membrane and podocytes. Typically, large proteins such as albumin and red blood cells are not filtered into the renal capsule cavity. However, elevated glomerular pressure and mesangial expansion result in changes in the surface area of the basement membrane and larger pores between podocytes, allowing larger proteins to enter the lumen of the renal capsule.

The ultrafiltrate collected in the renal capsule cavity is first delivered to the proximal convoluted tubules. Reabsorption and secretion of water and solutes in the renal tubules is achieved by both active transport channels and passive pressure gradients. The proximal convoluted tubule will normally reabsorb most of the sodium chloride and water as well as almost all of the glucose and amino acids that are filtered out by the glomeruli. The loop of henry has two components for concentrating waste in urine: the descending section is highly permeable and can reabsorb most of the residual water; the upleg reabsorbs 25% of the remaining sodium chloride, forming a concentrated urine, for example in terms of urea and creatinine. The distal convoluted tubule will normally reabsorb a small portion of sodium chloride and the osmotic gradient allows for water to follow.

Under normal conditions, the net filtration pressure is about 14 mmHg. The effect of venous congestion may be to significantly reduce the net filtration pressure down to about 4 mmHg. See Jessup m, The cardiac syndrome: do we' connected a change of geometry or a change of tacts? ,JACC53(7): 597-. The second filtration stage occurs in the proximal convoluted tubule. The secretion and absorption of urine occurs primarily in the tubules of the medullary nephron. This process is initiated by the active transport of sodium from the renal tubules to the interstitial space. However, hydrostatic pressure dominates the net exchange of solutes and water. Under normal conditions, 75% of the sodium is considered to be newly presentAspirated back into the lymphatic or venous circulation. However, the kidneys are encapsulated and thus sensitive to hydrostatic pressure changes caused by venous and lymphatic congestion. During venous congestion, the sodium and water retention may exceed 85%, thereby further sustaining renal congestion. See Verbrugge et al, The kidney incongestive heart failure: are natriesis, sodium, and diesel response the good, the bad and the ought?European Journal ofHeart Failure2014: 16, 133-42 (hereinafter referred to as "Verbrugge").

Venous congestion can lead to prerenal Acute Kidney Injury (AKI). Prerenal AKI is due to reduced renal perfusion (or reduced blood flow). A concern of many clinicians is insufficient renal blood inflow due to shock. However, there is also evidence that inadequate organ blood flow due to venous stasis may be a clinically important persistent injury. See Dammann K, Import of venous connectivity for working functional in advanced endless pending heart failure, JACC 17: 589-96, 2009 (hereinafter referred to as "Damman").

Prerenal AKI occurs in a variety of diagnoses requiring intensive care admission. The most prominent causes of hospitalization are sepsis and Acute Decompensated Heart Failure (ADHF). Other causes of admission include cardiovascular surgery, general surgery, cirrhosis, trauma, burns, and pancreatitis. Although these disorders exhibit extensive clinical variability in their performance, they have in common an elevated central venous pressure. In the case of ADHF, the elevated central venous pressure caused by heart failure can lead to pulmonary edema, which in turn makes breathing difficult and has to be admitted to a hospital. In the case of sepsis, the central venous pressure rise is mainly due to active fluid resuscitation. Whether the initial injury is hypo-perfusion due to hypovolemia or sodium and fluid retention, the persistent injury is venous stasis, which can lead to hypoperfusion.

Hypertension is another well-established condition that produces disturbances in the active and passive transport systems of the kidney. Hypertension directly affects the blood pressure in the sphenoid arterioles and results in an increased proportion of the net filtering pressure within the glomerulus. Increased filtration fraction also increases capillary pressure around the renal tubules, stimulating sodium and water reabsorption. See Verbrugge.

Since the kidney is a packed organ, it is sensitive to pressure changes in the medullary pyramid. An increase in renal venous pressure can cause congestion, resulting in an increase in interstitial pressure. Elevated interstitial pressure exerts forces on the glomeruli and tubules. See Verburgge. In the glomeruli, an increase in interstitial pressure directly impedes filtration. The increased pressure increases interstitial fluid, which increases the interstitial fluid in the renal medulla and the hydrostatic pressure in the peritubular capillaries. Hypoxia in both cases leads to cell damage and further perfusion loss. The net result is further increased sodium and water reabsorption, which creates negative feedback. See Verbrugge, 133-42. Fluid overload (particularly fluid overload within the abdominal cavity) is associated with a number of diseases and conditions, including increased intra-abdominal pressure, compartment syndrome, and acute renal failure. The problem of fluid overload can be solved by renal replacement therapy. See Peters, C.D., Short and Long-Term Effects of the Aeromonas II Receptor, Irbesartan intraspecific Central Hemodynamides: a random Double-flag plasma-Controlled One-Yeast interference Trial (the SAFIR Study), PLoS ONE (2015)10 (6): e0126882. doi: 10.1371/journal. bone.0126882 (hereinafter referred to as "Peters"). However, this clinical strategy does not improve renal function in patients with cardiorenal syndrome. See Bart B, Ultrafiltration in decompensated heart failure with cardiac synthesis,NEJM2012; 367: 2296 ion 2304 (hereinafter referred to as "Bart").

In view of the effects of this fluid retention problem, there is a need for improved devices and methods for draining urine from the urinary tract, and in particular for increasing the quantity and quality of urine drained from the kidneys.

Summary of The Invention

In some embodiments, a method of promoting renal urination is provided. The method comprises the following steps: (a) inserting a catheter into at least one of the patient's kidney, renal pelvis, or ureter proximate to the renal pelvis, wherein the catheter comprises a drainage lumen having a proximal portion and a distal portion located in the patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a period of time to promote renal urination.

In some embodiments, a ureteral catheter is provided having a drainage lumen with a proximal portion and a distal portion located in a patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion including a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings.

In some embodiments there is provided a system for introducing negative pressure in a portion of a urinary tract of a patient, the system comprising: at least one ureteral catheter having a drainage lumen, the drainage lumen having a proximal portion and a distal portion located in the patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings and extends to a deployed position where the diameter of the positioning portion is greater than the diameter of the drainage lumen, wherein the funnel stent has at least one drainage opening to allow fluid to flow into the drainage lumen; and a pump in fluid communication with a proximal portion of the drainage lumen, the pump configured to introduce negative pressure in a portion of a urinary tract of a patient to aspirate liquid through the drainage lumen of the ureteral catheter.

Methods of using the above-described catheters and systems are also provided.

In some embodiments, a method for removing urine from a patient's ureter and/or kidney to affect interstitial pressure in the kidney is provided. The method comprises the following steps: (a) inserting a catheter into at least one of the patient's kidney, renal pelvis, or ureter proximate to the renal pelvis, wherein the catheter comprises a drainage lumen having a proximal portion and a distal portion located in the patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a period of time to alter interstitial pressure within the patient's kidney.

In some embodiments, a method of preventing renal injury by applying negative pressure to reduce interstitial pressure within the tubules of the renal medullary region to facilitate urine drainage and prevent venous stasis-induced hypoxia of the nephrons in the renal medulla is provided. The method comprises the following steps: (a) inserting a catheter into at least one of the patient's kidney, renal pelvis, or ureter proximate to the renal pelvis, wherein the catheter comprises a drainage lumen having a proximal portion and a distal portion located in the patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a period of time to promote renal urination.

In another embodiment, a method for treating acute kidney injury caused by venous congestion is provided. The method comprises the following steps: (a) inserting a catheter into at least one of the patient's kidney, renal pelvis, or ureter proximate to the renal pelvis, wherein the catheter comprises a drainage lumen having a proximal portion and a distal portion located in the patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a period of time to promote renal urination and reduce renal vein congestion, thereby treating acute renal injury.

In some embodiments, a method of treating New York Heart Association (NYHA) grade III and/or Iv heart failure by reducing venous stasis of the kidney is provided. The method comprises the following steps: (a) inserting a catheter into at least one of the patient's kidney, renal pelvis, or ureter proximate to the renal pelvis, wherein the catheter comprises a drainage lumen having a proximal portion and a distal portion located in the patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a predetermined period of time to treat volume overload in nyhaiiii and/or IV heart failure.

In some embodiments, a method of treating stage 4 and/or 5 chronic kidney disease by reducing venous stasis in the kidney is provided. The method comprises the following steps: (a) inserting a catheter into at least one of the patient's kidney, renal pelvis, or ureter proximate to the renal pelvis, wherein the catheter comprises a drainage lumen having a proximal portion and a distal portion located in the patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a predetermined period of time to treat stage 4 and/or stage 5 chronic kidney disease.

Non-limiting examples, aspects or embodiments of the invention will be described in the following claims.

The method of claim 1: a method of promoting renal urination, comprising: (a) inserting a catheter into at least one of a kidney, a renal pelvis, or a ureter proximate to the renal pelvis of a patient, wherein the catheter comprises a drainage lumen having a proximal portion and a distal portion located in the kidney, the renal pelvis, and/or the ureter proximate to the renal pelvis of the patient, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being smaller than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and (b) applying negative pressure to the proximal portion of the drainage lumen for a period of time to promote renal urination.

The method of claim 2: the method of claim 1, wherein the catheter blocks the ureter and/or kidney without preventing urine from flowing out of the ureter and/or kidney.

The method of claim 3: the method of claim 1, wherein the funnel holder is generally conical.

The method of claim 4: the method of claim 1, wherein the funnel holder is generally hemispherical.

The method of claim 5: the method of claim 1, wherein the funnel stent has a base adjacent the distal portion of the drainage lumen, the base having at least one opening aligned with an interior of the proximal portion of the drainage lumen to allow liquid to flow into the interior of the proximal portion of the drainage lumen.

The method of claim 6: the method of claim 5, wherein the at least one opening of the base is about 0.05mm to about 4mm in diameter.

The method of claim 7: the method of claim 1, wherein said at least one sidewall of said funnel support has a height along a central axis of said funnel support.

The method of claim 8: the method of claim 7, wherein the height of the at least one sidewall of the funnel support is from about 1mm to about 25 mm.

The method of claim 9: the method of claim 7, wherein a ratio between a height of the at least one sidewall of the funnel support and the second diameter is about 1: 25 to about 5: 1.

The method of claim 10: the method of claim 5, wherein the diameter of the at least one opening of the base is about 0.05mm to about 4mm, the height of the at least one sidewall of the funnel holder is about 1mm to about 25mm, and the second diameter of the funnel holder is about 5mm to about 25 mm.

The method of claim 11: the method of claim 1, wherein said at least one side wall of said funnel support is continuous along its height.

The method of claim 12: the method of claim 1, wherein the at least one side wall of the funnel support has a solid wall.

The method of claim 13: the method of claim 1, wherein the at least one sidewall of the funnel support is formed by a balloon.

The method of claim 14: the method of claim 1, wherein said at least one side wall of said funnel support is discontinuous along its height.

The method of claim 15: the method of claim 1, wherein the at least one sidewall of the funnel support has at least one opening.

The method of claim 16: the method of claim 1, wherein the at least one opening has an area of about 0.002mm²To about 50mm²。

The method of claim 17: the method of claim 1, wherein the at least one sidewall of the funnel support comprises at least a first coil having a first diameter and a second coil having a second diameter, and the first diameter is less than the second diameter, wherein a maximum distance between a portion of the sidewall of the first coil and a portion of an adjacent sidewall of the second coil is about 0mm to about 10 mm.

The method of claim 18: the method of claim 17, wherein the first diameter of the first coil is about 1mm to about 10mm and the second diameter of the second coil is about 5mm to about 25 mm.

The method of claim 19: the method of claim 17, wherein the diameter of the coil increases in a direction toward the distal end of the drainage lumen, thereby forming a helix having a tapered or partially tapered configuration.

The method of claim 20: the method of claim 1, wherein the at least one sidewall of the funnel stent has a mesh with a plurality of openings therethrough to allow fluid to flow into the drainage lumen; wherein the maximum area of the opening is up to about 100mm²。

The method of claim 21: the method of claim 1, wherein the at least one sidewall of the funnel stent has an inward side and an outward side, the inward side having at least one opening that allows liquid to flow into the drainage lumen, and the outward side having no or substantially no openings.

The method of claim 22: the method of claim 21, wherein the at least one opening has an area of about 0.002mm²To about 100mm²。

The method of claim 23: the method of claim 17, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen.

The method of claim 24: the method of claim 17, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least two openings to allow liquid to flow into the drainage lumen.

The method of claim 25: the method of claim 17, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially outward side of the first coil is free or substantially free of one or more openings.

The method of claim 26: the method of claim 17, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow liquid to flow into the drainage lumen, the radially outward side being free or substantially free of one or more openings.

The method of claim 27: the method of claim 15, wherein the at least one opening in the sidewall of the drainage lumen allows liquid to flow into the drainage lumen under negative pressure.

The method of claim 28: the method of claim 1, wherein the positioning portion of the drainage lumen further has an open distal end to allow fluid to flow into the drainage lumen.

The method of claim 29: the method of claim 1, wherein the funnel stent has at least a third diameter, and the third diameter is smaller than the second diameter, the third diameter being closer to an end of the distal portion of the drainage lumen than the second diameter.

The method of claim 30: the method of claim 15, wherein the one or more openings are circular.

The method of claim 31: the method of claim 15, wherein the one or more openings are non-circular.

The method of claim 32: the method of claim 1, wherein the at least one sidewall of the funnel support is convex.

The method of claim 33: the method of claim 1, wherein the at least one sidewall of the funnel support is concave.

The method of claim 34: the method of claim 1, wherein a central axis of the funnel stent is offset from a central axis of the tube of the drainage lumen.

The method of claim 35: the method of claim 1, wherein said distal end of said positioning portion of said funnel support has a plurality of substantially rounded edges.

The method of claim 36: the method of claim 1, wherein the at least one sidewall of the funnel support has a plurality of lobe-shaped longitudinal pleats.

The method of claim 37: the method of claim 36, wherein the at least one burst-shaped longitudinal pleat has at least one longitudinal support.

The method of claim 38: the method of claim 36, wherein the distal end of the at least one burst-shaped longitudinal pleat has at least one support.

The method of claim 39: the method of claim 1, wherein the at least one sidewall of the funnel support comprises an inner sidewall and an outer sidewall, the inner sidewall having at least one opening to allow liquid to flow therethrough into the interior of the proximal portion of the drainage lumen.

The method of claim 40: the method of claim 1, wherein the funnel support comprises a porous material located inside the sidewall.

The method of claim 41: the method of claim 1, wherein the funnel support comprises a porous liner located adjacent an interior of the sidewall.

The method of claim 42: the method of claim 1, wherein said catheter is convertible between a collapsed configuration for insertion into a patient ureter and an expanded configuration for deployment within said ureter.

The method of claim 43: the method of claim 1, wherein the drainage lumen is made at least in part of one or more materials of copper, silver, gold, nitinol, stainless steel, titanium, polyurethane, polyvinyl chloride, Polytetrafluoroethylene (PTFE), latex, and silicone.

The method of claim 44: a ureteral catheter comprising a drainage lumen having a proximal portion and a distal portion located in a patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings.

The method of claim 45: the ureteral catheter of claim 44, wherein the catheter blocks the ureter and/or kidney without preventing urine from flowing out of the ureter and/or kidney.

The method of claim 46: the ureteral catheter of claim 44, wherein the funnel stent is generally conical.

The method of claim 47: the ureteral catheter of claim 44, wherein the funnel stent is generally hemispherical.

The method of claim 48: the ureteral catheter of claim 44, wherein the funnel stent has a base adjacent the distal portion of the drainage lumen, the base having at least one opening aligned with an interior of the proximal portion of the drainage lumen to allow liquid to flow into the interior of the proximal portion of the drainage lumen.

The method of claim 49: the ureteral catheter of claim 48, wherein the diameter of the at least one opening of the base is from about 0.05mm to about 4 mm.

The method of claim 50: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has a height along a central axis of the funnel stent.

The method of claim 51: the ureteral catheter of claim 50, wherein the height of the at least one sidewall of the funnel stent is from about 1mm to about 25 mm.

The method of claim 52: the ureteral catheter of claim 50, wherein the ratio between the height of the at least one sidewall of the funnel stent and the second diameter is from about 1: 25 to about 5: 1.

The method of claim 53: the ureteral catheter of claim 48, wherein the diameter of the at least one opening of the base is from about 0.05mm to about 4mm, the height of the at least one sidewall of the funnel stent is from about 1mm to about 25mm, and the second diameter of the funnel stent is from about 5mm to about 25 mm.

The method of claim 54: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is continuous along its height.

The method of claim 55: the ureteral catheter of claim 44, wherein the at least one side wall of the funnel stent has a solid wall.

The method of claim 56: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is formed from a balloon.

The method of claim 57: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is discontinuous along its height.

The method of claim 58: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has at least one opening.

The method of claim 59: the ureteral catheter of claim 44, wherein the area of the at least one opening is about 0.002mm²To about 50mm²。

The method of claim 60: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent comprises at least a first coil having a first diameter and a second coil having a second diameter, and the first diameter is less than the second diameter, wherein a maximum distance between a portion of a sidewall of the first coil and a portion of an adjacent sidewall of the second coil is from about 0mm to about 10 mm.

The method of claim 61: the ureteral catheter of claim 60, wherein the first diameter of the first coil is from about 1mm to about 10mm, and the second diameter of the second coil is from about 5mm to about 25 mm.

The method of claim 62: the ureteral catheter of claim 60, wherein the diameter of the coil increases toward a distal end of the drainage lumen, thereby forming a helical structure having a tapered or partially tapered configuration.

The method of claim 63: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has a mesh with a plurality of openings therethrough to allow fluid to flow into the drainage lumen; wherein the maximum area of the opening is up to about 100mm²。

The method of claim 64: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has an inward side and an outward side, the inward side having at least one opening that allows fluid to flow into the drainage lumen, and the outward side being free or substantially free of openings.

The method of claim 65: the ureteral catheter of claim 64, wherein the area of the at least one opening is about 0.002mm²To about 100mm²。

The method of claim 66: the ureteral catheter of claim 60, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen.

The process of claim 67: the ureteral catheter of claim 60, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least two openings to allow fluid to flow into the drainage lumen.

The method of claim 68: the ureteral catheter of claim 60, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially outward side of the first coil is free of, or substantially free of, one or more openings.

The method of claim 69: the ureteral catheter of claim 60, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen, the radially outward side being free or substantially free of one or more openings.

The method of claim 70: the ureteral catheter of claim 58, wherein the at least one opening in the sidewall of the drainage lumen allows liquid to flow into the drainage lumen under the influence of negative pressure.

The method of claim 71: the ureteral catheter of claim 44, wherein the positioning portion of the drainage lumen further has an open distal end to allow fluid to flow into the drainage lumen.

The method of claim 72: the ureteral catheter of claim 4, wherein the funnel stent has a third diameter, and the third diameter is smaller than the second diameter, the third diameter being closer to an end of the distal portion of the drainage lumen than the second diameter.

The method of claim 73: the ureteral catheter of claim 58, wherein the one or more openings are circular.

The method of claim 74: the ureteral catheter of claim 58, wherein the one or more openings are non-circular.

The method of claim 75: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is convex.

The method of claim 76: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is concave.

The method of claim 77: the ureteral catheter of claim 44, wherein a central axis of the funnel stent is offset from a central axis of the tube of the drainage lumen.

The method of claim 78: the ureteral catheter of claim 44, wherein the distal end of the positioning portion of the funnel stent has a plurality of substantially rounded edges.

The method of claim 79: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has a plurality of lobe-shaped longitudinal pleats.

The method of claim 80: the ureteral catheter of claim 79, wherein the at least one split-shaped longitudinal pleat has at least one longitudinal support.

The method of claim 81: the ureteral catheter of claim 79, wherein the distal end of the at least one split-shaped longitudinal pleat has at least one support.

The method of claim 82: the ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent comprises an inner sidewall and an outer sidewall, the inner sidewall having at least one opening to allow liquid to flow therethrough into an interior of the proximal portion of the drainage lumen.

The method of claim 83: the ureteral catheter of claim 44, wherein the funnel stent comprises a porous material located inside the sidewall.

The method of claim 84: the ureteral catheter of claim 44, wherein the funnel stent comprises a porous liner located adjacent to an interior of the sidewall.

The method of claim 85: the ureteral catheter of claim 44, wherein the catheter is transitionable between a collapsed configuration for insertion into a patient ureter and an expanded configuration for deployment within the ureter.

The method of claim 86: the ureteral catheter of claim 44, wherein the drainage lumen is made at least partially from one or more materials of copper, silver, gold, nickel titanium alloy, stainless steel, titanium, polyurethane, polyvinyl chloride, Polytetrafluoroethylene (PTFE), latex, and silicone.

The process of claim 87: a system for introducing negative pressure in a portion of a urinary tract of a patient, the system comprising: at least one ureteral catheter having a drainage lumen having a proximal portion and a distal portion located in a patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings and extends to a deployed position enabling the diameter of the positioning portion to be greater than the diameter of the drainage lumen, wherein the funnel stent has at least one drainage opening to allow fluid to flow into the drainage lumen; and a pump in fluid communication with the proximal portion of the drainage lumen, the pump configured to introduce negative pressure in a portion of a urinary tract of a patient to draw liquid through the drainage lumen of the ureteral catheter.

The process of claim 88: the system of claim 87, wherein the catheter blocks the ureter and/or kidney without preventing urine from flowing out of the ureter and/or kidney.

The method of claim 89: the system of claim 87, wherein the funnel support is generally conical.

The method of claim 90: the system of claim 87, wherein the funnel holder is generally hemispherical.

The method of claim 91: the system of claim 87, wherein the funnel stent has a base adjacent the distal portion of the drainage lumen, the base having at least one opening aligned with an interior of the proximal portion of the drainage lumen to allow liquid to flow into the interior of the proximal portion of the drainage lumen.

The method of claim 92: the system of claim 91, wherein the at least one opening of the base has a diameter of about 0.05mm to about 4 mm.

The method of claim 93: the system of claim 87, wherein the at least one sidewall of the funnel support has a height along a central axis of the funnel support.

The method of claim 94: the system of claim 93, wherein the height of said at least one side wall of said funnel support is from about 1mm to about 25 mm.

The process of claim 95: the system of claim 93, wherein a ratio between a height of said at least one side wall of said funnel support and said second diameter is about 1: 25 to about 5: 1.

The method of claim 96: the system of claim 91, wherein the at least one opening of the base is about 0.05mm to about 4mm in diameter, the at least one sidewall of the funnel support is about 1mm to about 25mm in height, and the second diameter of the funnel support is about 5mm to about 25 mm.

The process of claim 97: the system of claim 87, wherein the at least one side wall of the funnel support is continuous along its height.

The process of claim 98: the system of claim 87, wherein the at least one side wall of the funnel support has a solid wall.

The method of claim 99: the system of claim 87, wherein the at least one sidewall of the funnel support is formed by a balloon.

The method of claim 100: the system of claim 87, wherein the at least one sidewall of the funnel support is discontinuous along its height.

The method of claim 101: the system of claim 87, wherein the at least one sidewall of the funnel support has at least one opening.

The method of claim 102: the system of claim 87, wherein the at least one opening has an area of about 0.002mm²To about 100mm²。

The method of claim 103: the system of claim 87, wherein the at least one sidewall of the funnel support comprises at least a first coil having a first diameter and a second coil having a second diameter, and the first diameter is less than the second diameter, wherein a maximum distance between a portion of the sidewall of the first coil and a portion of an adjacent sidewall of the second coil is about 0mm to about 10 mm.

The method of claim 104: the system of claim 103, wherein the first diameter of the first coil is about 1mm to about 10mm and the second diameter of the second coil is about 5mm to about 25 mm.

The method of claim 105: the system of claim 103, wherein the diameter of the coil increases in a direction toward a distal end of the drainage lumen, thereby forming a helix having a tapered or partially tapered configuration.

The method of claim 106: the system of claim 87, wherein the at least one sidewall of the funnel support has a mesh with a plurality of openings therethrough to allow fluid to flow into the drainage lumen; wherein the maximum area of the opening is up to about 100mm²。

The method of claim 107: the system of claim 87, wherein the at least one sidewall of the funnel support has an inward side and an outward side, the inward side having at least one opening that allows fluid to flow into the drainage lumen, and the outward side having no or substantially no openings.

The method of claim 108: the system of claim 107, wherein the at least one opening has an area of about 0.002mm²To about 100mm²。

The process of claim 109: the system of claim 103, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen.

The method of claim 110: the system of claim 103, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least two openings to allow fluid to flow into the drainage lumen.

The method of claim 111: the system of claim 103, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially outward side of the first coil is free or substantially free of one or more openings.

The method of claim 112: the system of claim 103, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen, the radially outward side being free or substantially free of one or more openings.

The process of claim 113: the system of claim 101, wherein the at least one opening in the sidewall of the drainage lumen allows liquid to flow into the drainage lumen under negative pressure.

The method of claim 114: the system of claim 87, wherein the positioning portion of the drainage lumen further has an open distal end to allow fluid to flow into the drainage lumen.

The process of claim 115: the system of claim 87, wherein the funnel stent has a third diameter, and the third diameter is smaller than the second diameter, the third diameter being closer to an end of the distal portion of the drainage lumen than the second diameter.

The method of claim 116: the system of claim 101, wherein the one or more openings are circular.

The method of claim 117: the system of claim 101, wherein the one or more openings are non-circular.

The process of claim 118: the system of claim 87, wherein the at least one sidewall of the funnel support is convex.

The process of claim 119: the system of claim 87, wherein the at least one sidewall of the funnel support is concave.

The method of claim 120: the system of claim 87, wherein a central axis of the funnel stent is offset from a central axis of the tube of the drainage lumen.

The process of claim 121: the system of claim 87 wherein the distal end of the positioning portion of the funnel support has a plurality of substantially rounded edges.

The method of claim 122: the system of claim 87, wherein the at least one sidewall of the funnel support has a plurality of lobe-shaped longitudinal pleats.

The method of claim 123: the system of claim 122, wherein the at least one burst-shaped longitudinal pleat has at least one longitudinal support.

The process of claim 124: the system of claim 122, wherein the distal end of the at least one split-shaped longitudinal pleat has at least one support.

The method of claim 125: the system of claim 87, wherein the at least one side wall of the funnel support comprises an inner side wall and an outer side wall, the inner side wall having at least one opening to allow liquid to flow therethrough into the interior of the proximal portion of the drainage lumen.

The process of claim 126: the system of claim 87, wherein the funnel support comprises a porous material positioned inside the sidewall.

The method of claim 127: the system of claim 87, wherein the funnel support comprises a porous liner located adjacent an interior of the sidewall.

The method of claim 128: the system of claim 87, wherein the catheter is transitionable between a collapsed configuration for insertion into a patient ureter and an expanded configuration for deployment within the ureter.

The process of claim 129: the system of claim 87, wherein the drainage lumen is made at least in part of one or more materials of copper, silver, gold, nitinol, stainless steel, titanium, polyurethane, polyvinyl chloride, Polytetrafluoroethylene (PTFE), latex, and silicone.

Drawings

These and other features and characteristics of the present invention, the methods of operation and functions of the related elements of structure, and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.

Further features, other embodiments and advantages will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a schematic view of an indwelling portion of a urine collection assembly according to an embodiment of the present invention deployed in a patient's urinary tract;

fig. 2A is a perspective view of an exemplary ureteral catheter, according to an embodiment of the present invention;

FIG. 2B is a front view of the ureteral catheter of FIG. 2A;

figure 3A is a schematic view of an embodiment of a ureteral catheter positioning portion, according to an embodiment of the present disclosure;

figure 3B is a schematic view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present disclosure;

figure 3C is a schematic view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present disclosure;

figure 3D is a schematic view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present disclosure;

figure 3E is a schematic view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present disclosure;

figure 4A is a schematic view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present disclosure;

FIG. 4B is a cross-sectional view of a portion of the positioning portion taken along line B-B in FIG. 4A;

figure 5A is a schematic view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present disclosure;

FIG. 5B is a cross-sectional view of a portion of the positioning portion taken along line B-B in FIG. 5A;

figure 6 is a schematic view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present invention;

figure 7 is a schematic cross-sectional view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present disclosure;

figure 8 is a schematic view of another embodiment of a ureteral catheter positioning portion, according to an embodiment of the present invention;

FIG. 9A is a schematic view of another embodiment of a urine collection assembly according to one embodiment of the present invention;

FIG. 9B is a fragmentary schematic view taken along section 9B-9B of the bladder anchoring portion of the assembly in FIG. 9A;

FIG. 10A is a schematic view of another embodiment of a urine collection assembly according to one embodiment of the present invention;

FIG. 10B is a schematic view taken along section 10B-10B of the bladder anchoring portion of the assembly in FIG. 10A;

FIG. 11A is a schematic view of a urine collection assembly according to one embodiment of the present invention;

FIG. 11B is a schematic view taken along section 11B-11B of the bladder anchoring portion of the assembly of FIG. 11A;

FIG. 12A is a schematic view of another bladder anchoring portion of a urine collection assembly according to an embodiment of the present invention;

FIG. 12B is a cross-sectional schematic view of the bladder catheter of the urine collection assembly taken along line C-C in FIG. 12A;

FIG. 12C is a cross-sectional schematic view of another embodiment of a bladder catheter of the urine collection assembly;

FIG. 13 is a schematic view of another embodiment of the bladder anchoring portion of a urine collection assembly according to one embodiment of the present invention;

FIG. 14 is a schematic view of another embodiment of the bladder anchoring portion of a urine collection assembly according to one embodiment of the present invention;

FIG. 15 is a schematic view of another embodiment of the bladder anchoring portion of a urine collection assembly deployed in the bladder and urethra of a patient in accordance with an embodiment of the present invention;

FIG. 16 is a schematic view of another embodiment of the bladder anchoring portion of a urine collection assembly according to one embodiment of the present invention;

FIG. 17A is an exploded perspective view of a fitting of a urine collection assembly according to one embodiment of the present invention;

FIG. 17B is a cross-sectional view of a portion of the joint of FIG. 17A;

FIG. 17C is a schematic view of a fitting of a urine collection assembly according to one embodiment of the present invention;

figure 18A is a flow chart illustrating a process for inserting and deploying a ureteral catheter or urine collection assembly according to an embodiment of the present invention;

figure 18B is a flow chart illustrating a process for introducing negative pressure using a ureteral catheter or urine collection assembly according to an embodiment of the present invention;

FIG. 19 is a schematic view of a system for introducing negative pressure into a patient's urinary tract, in accordance with an embodiment of the present invention;

FIG. 20A is a plan view of a pump used in the system of FIG. 19 according to an embodiment of the present invention;

FIG. 20B is a side view of the pump of FIG. 20A;

fig. 21 is a schematic diagram of an experimental apparatus for evaluating negative pressure therapy in a pig model;

figure 22 shows creatinine clearance measured using the experimental setup of figure 21;

FIG. 23A is a photomicrograph of kidney tissue from a extravasated kidney treated with negative pressure therapy;

FIG. 23B is a photomicrograph of the kidney tissue of FIG. 23A;

FIG. 23C is a photomicrograph of kidney tissue from a fouled and untreated kidney (e.g., control kidney);

FIG. 23D is a high power micrograph of the kidney tissue of FIG. 23C;

figure 24 is a flow chart illustrating a process for reducing creatinine and/or protein levels in a patient according to an embodiment of the present invention;

FIG. 25 is a flow chart illustrating a process for resuscitating a patient with therapeutic fluid according to one embodiment of the present invention;

FIG. 26 shows the change from baseline in serum albumin from an experiment conducted on pigs using the experimental methods described herein;

FIG. 27 is a schematic view of another embodiment of an indwelling portion of a urine collection assembly according to one embodiment of the present invention deployed in a patient's urinary tract;

FIG. 28 is another schematic view of the urine collection assembly of FIG. 27;

fig. 29 is a front view of another embodiment of a ureteral catheter, according to an embodiment of the present invention;

figure 30A is a perspective view of the ureteral catheter positioning portion, indicated by the circle 30A in figure 29, according to an embodiment of the present invention;

figure 30B is a front view of the positioning portion of figure 30A, in accordance with one embodiment of the present invention;

figure 30C is a rear view of the positioning portion of figure 30A, in accordance with one embodiment of the present invention;

figure 30D is a top view of the positioning portion of figure 30A, in accordance with one embodiment of the present invention;

FIG. 30E is a cross-sectional view of the positioning section taken along line 30E-30E in FIG. 30A, in accordance with one embodiment of the present invention;

figure 31 is a schematic view of a ureteral catheter positioning portion in a constrained or linear position, according to an embodiment of the present invention;

figure 32 is a schematic view of another embodiment of a ureteral catheter positioning portion in a constrained or linear position, as described in an embodiment of the present invention;

figure 33 is a schematic view of another embodiment of a ureteral catheter positioning portion in a constrained or linear position, as described in an embodiment of the present invention;

figure 34 is a schematic view of another embodiment of a ureteral catheter positioning portion in a constrained or linear position, as described in an embodiment of the present invention;

FIG. 35A illustrates the percent flow of a liquid through an opening of an exemplary ureteral catheter as a function of location, according to an embodiment of the present invention;

FIG. 35B illustrates the percent flow of a liquid through an opening of another exemplary ureteral catheter as a function of location of flow, according to an embodiment of the present invention;

FIG. 35C illustrates the percent flow of a liquid through an opening of another exemplary ureteral catheter as a function of the location of the liquid flow, according to an embodiment of the present invention;

figure 36 is a perspective view of a tube assembly and Y-fitting for connecting a ureteral catheter to a fluid pump according to an embodiment of the present invention;

figure 37 is a perspective view of a ureteral catheter according to an embodiment of the present invention connected to the Y-junction shown in figure 36;

fig. 38 is a schematic diagram of a ureteral catheter positioning section, showing a "station" for calculating liquid flow coefficients for mass transfer balance assessment, according to an embodiment of the present invention;

FIG. 39 is a schematic view of the nephron and peripheral vasculature showing the location of the capillary bed and convoluted tubules;

FIG. 40 is a schematic view of an indwelling portion of a urine collection assembly according to another embodiment of the present invention deployed in a urinary tract of a patient;

figure 41A is a side elevational view of a ureteral catheter positioning portion, according to an embodiment of the present invention;

figure 41B is a cross-sectional view of the positioning portion of the ureteral catheter taken along line B-B in figure 41A;

figure 41C is a top view of the ureteral catheter positioning portion taken along line C-C in figure 41A;

figure 42 is a side elevational view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 43 is a side elevational view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 44 is a side elevational view of a positioning portion of another ureteral catheter, according to an embodiment of the present invention;

figure 45A is a perspective view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 45B is a top view of the positioning portion of the ureteral catheter taken along line B-B in figure 45A;

figure 46A is a perspective view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 46B is a top view of the positioning portion of the ureteral catheter taken along line B-B in figure 46A;

fig. 47 is a perspective view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 48 is a side elevational view of a positioning portion of another ureteral catheter, according to an embodiment of the present invention;

figure 49 is a side elevational view of a positioning portion of another ureteral catheter, according to an embodiment of the present invention;

figure 50 is a cross-sectional side view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

fig. 51A is a perspective view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 51B is a top view of the ureteral catheter locating portion of figure 51A;

figure 52A is a perspective view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 52B is a top view of the positioning portion of the ureteral catheter of figure 52A;

figure 53A is a perspective view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 53B is a top view of the ureteral catheter locating portion of figure 53A;

figure 54 is a perspective view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 54B is a top view of the ureteral catheter positioning portion of figure 54A;

figure 55 is a cross-sectional side elevational view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 56 is a cross-sectional side elevational view of a positioning portion of another ureteral catheter, according to an embodiment of the present invention;

figure 57A is a perspective view of a locating portion of another ureteral catheter, according to an embodiment of the present invention;

figure 57B is a cross-sectional side elevational view of the positioning portion of the ureteral catheter taken along line B-B in figure 57A; and

the side elevational view in fig. 58 shows a cross-sectional view of a ureteral catheter peripheral sheath according to an embodiment of the present invention, wherein the ureteral catheter is in a collapsed configuration for insertion into the ureter of a patient.

Detailed Description

As used herein, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.

As used herein, the terms "right," "left," "top," and the like are to be construed in reference to the orientation thereof in the drawings to which the invention pertains. By "proximal" is meant the portion of the catheter device that is manipulated or contacted by the user and/or the portion of the indwelling catheter that is closest to the site of urinary tract entry. "distal" refers to the opposite end of the catheter device that is inserted into the patient and/or the portion of the catheter device that is inserted the furthest extent of the patient's urinary tract. It is to be understood, however, that the invention can assume various other orientations and, accordingly, such terms are not to be considered as limiting. In addition, it is to be understood that the invention may assume various other variations and step sequences, except where expressly specified otherwise. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

For the purposes of this specification, all numbers expressing quantities of ingredients, reaction conditions, dimensions, physical characteristics, and so forth, used in the specification and claims are to be understood as being modified in all instances by the term "about", unless otherwise indicated. The numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties to be obtained by the present invention, unless otherwise specified.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

Moreover, it should be understood that any numerical range recited herein is intended to include all sub-ranges subsumed therein. For example, a range of "1 to 10" is intended to include any and all subranges between the recited minimum value of 1 and maximum value of 10 (including the minimum value of 1 and the maximum value of 10), i.e., all subranges from a minimum value of equal to or greater than 1 to a maximum value of equal to or less than 10, and all subranges therebetween, e.g., 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1.

As used herein, "communicate" refers to receiving or transmitting one or more signals, messages, commands, or other types of data. By one unit or component being in communication with another unit or component, it is meant that one unit or component is capable of directly or indirectly receiving data from and/or transmitting data to the other unit or component. This may be accomplished through a direct or indirect connection that may be wired and/or wireless in nature. In addition, the two units or components may also communicate with each other, even though the transmitted data may be modified, processed, routed, etc., between the first and second units or components. For example, a first unit may communicate with a second unit even if the first unit passively receives data and does not actively transmit data to the second unit. As another example, a first unit may communicate with a second unit if an intermediate unit processes data from one unit and sends the processed data to the second unit. It will be appreciated that many other arrangements are possible.

Fluid retention and venous stasis are central problems in the development of end-stage renal disease. Excessive sodium intake coupled with a relatively reduced excretion can lead to isotonic volume expansion and secondary compartment involvement. In some embodiments, the present invention relates generally to devices and methods for facilitating the removal of urine or waste products from the bladder, ureter, and/or kidney of a patient. In some embodiments, the present invention relates generally to devices and methods for introducing negative pressure in the bladder, ureter, and/or kidney of a patient. While not wishing to be bound by any theory, it is believed that the introduction of negative pressure in the bladder, ureter and/or kidney may, in some cases, counteract reabsorption of sodium and water by the medullary tubules. Counteracting sodium and water reabsorption increases urine volume, reduces systemic sodium levels, and promotes erythropoiesis. Since the intramedullary pressure is driven by sodium and thus by volume overload, targeted removal of excess sodium can sustain volume loss. Reduction of volume restores medullary hemostasis. The normal urination rate is 1.48-1.96 liters/day (or 1-1.4 mL/min).

Fluid retention and venous stasis are also central problems in the progression of prerenal Acute Kidney Injury (AKI). In particular, AKI may be associated with perfusion loss or blood flow through the kidney. Thus, in some embodiments, the present invention helps to improve renal hemodynamic status and increase urine volume to alleviate or reduce venous congestion. Furthermore, it is contemplated that treating and/or inhibiting AKI may positively affect and/or reduce other diseases, such as reducing or inhibiting worsening renal function in NYHA class III and/or IV heart failure patients. A classification of different degrees of heart failure is described in The criterion Committee of The New YorkHeart Association (1994),Nomenclatureand Criteria for Diagnosis of Diseases of the Heart and Great Vessels，(9th ed.)，Boston：Little，Brown&pp.253-256, the disclosure of which is incorporated herein by reference in its entirety. Reducing or inhibiting the onset of AKI and/or chronically reducing perfusion may also be a method of treating stage 4 and/or 5 chronic kidney disease. For the progression of Chronic Kidney Disease, the national Kidney Foundation K/DOQIclinical Practice Guidelines for Chronic Kidney Disease: evaluation, Classification and Classification. am.j.kidney dis.39: S1-S266, 2002(suppl.1), the disclosure of which is incorporated herein by reference in its entirety.

Referring to fig. 1, 27 and 40, the urinary tract includes the right 2 and left 4 kidneys of the patient. As mentioned above, the kidneys 2, 4 are responsible for filtering blood and removing waste compounds from the body via urine. Urine produced by the right and left kidneys 2, 4 is discharged through small tubes (i.e., the right and left ureters 6, 8) into the bladder 10 of the patient. For example, urine can flow through the

ureters

6, 8 by gravity and peristaltic movement of the ureter wall. The

ureters

6, 8 enter the bladder 10 through ureter orifices or openings 16. The bladder 10 is a substantially hollow, flexible structure adapted to collect urine until the urine is discharged from the body. The bladder 10 can transition from an empty position (as indicated by reference line E) to a full position (as indicated by reference line F). Generally, when the bladder 10 reaches a substantially full condition, urine can drain from the bladder 10 into the urethra 12 through a urethral sphincter muscle or opening 18 located in the lower portion of the bladder 10. The bladder 10 can respond to stress and pressure exerted on the trigone 14 of the bladder 10 by contracting, which refers to the trigone extending between the ureteral opening 16 and the urethral opening 18. The trigone 14 is sensitive to stress and pressure such that when the bladder 10 begins to fill, the pressure on the trigone 14 increases. When the threshold pressure of the trigone 14 is exceeded, the bladder 10 begins to contract to expel the collected urine through the urethra 12.

In some embodiments, a method of promoting renal urination is provided. The method comprises the following steps: (a) inserting the inventive catheter disclosed herein into at least one of a kidney, a renal pelvis, or a ureter proximate to the renal pelvis of a patient, and (b) applying negative pressure to a proximal portion of a drainage lumen of the catheter for a period of time to promote renal urination. Specific features of exemplary ureteral catheters of the present invention are detailed herein.

Exemplary ureteral catheters:

as shown in fig. 40, two exemplary ureteral catheters 5000, 5001 are shown positioned within a patient's urinary tract. The ureteral catheter 5000, 5001 includes a

drainage lumen

5002, 5003 to drain a liquid, such as urine, from the patient's kidneys 2, 4 and at least one of the

renal pelvis

20, 21 or

ureters

6, 8 proximate to the

renal pelvis

20, 21. The

drainage lumens

5002, 5003 include

distal portions

5004, 5005 and

proximal portions

5006, 5007, the

distal portions

5004, 5005 are located in the patient's kidneys 2, 4 and/or

renal pelvis

20, 21 and/or

ureters

6, 8 proximal to the

renal pelvis

20, 21, and the liquid 5008 drains through the

proximal portions

5006, 5007 into or out of the patient's bladder 10.

In some embodiments, the

distal portions

5004, 5005 include open

distal ends

5010, 5011 for introducing liquids into the

drainage lumens

5002, 5003. The

distal portion

5004, 5005 of the ureteral catheter 5000, 5001 further comprises a locating

portion

5012, 5013 to fix the position of the

distal portion

5004, 5005 of the drainage lumen or

tube

5002, 5003 in the ureter and/or kidney. The

detents

5012, 5013 can be flexible and/or bendable to enable the

detents

5012, 5013 to be secured in the ureter, renal pelvis, and/or kidney. For example, it is desirable that the locating

portions

5012, 5013 be sufficiently flexible to absorb forces exerted on the catheter 5000, 5001 and prevent such forces from being transmitted to the ureter. Further, if the locating

portions

5012, 5013 are pulled toward the patient's bladder 10 in the proximal direction P (as shown in fig. 40), the locating

portions

5012, 5013 can begin to unfold, straighten, or fold sufficiently flexibly so as to be pulled through the

ureters

6, 8.

The locating

portions

5012, 5013 can be made of the same material as the drainage lumens and can be integral with the

drainage lumens

5002, 5003 or the locating

portions

5012, 5013 can be made of a different material than the

drainage lumens

5002, 5003 and connected thereto. The

drainage lumens

5002, 5003 can be at least partially made of one or more materials of copper, silver, gold, nitinol, stainless steel, titanium, and/or polymers such as polyurethane, polyvinyl chloride, Polytetrafluoroethylene (PTFE), latex, and/or silicone. The locating

portions

5012, 5013 can be made of any of the above materials as well as polymers such as: polyurethane, flexible polyvinyl chloride, Polytetrafluoroethylene (PTFE), latex, silicone, polyglycolide or polyglycolic acid (PGA), Polylactide (PLA), poly (lactide-co-glycolide), polyhydroxyalkanoates, polycaprolactone, and/or polypropylene fumarate.

Typically, the positioning portion has a funnel stent having at least one sidewall with a first diameter and a second diameter, and the first diameter is smaller than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter.

The drainage lumen or proximal portion of the drainage tube has no or substantially no openings. While not wishing to be bound by any theory, it is believed that when negative pressure is applied proximal to the proximal portion of the drainage lumen, it may not be desirable to have an opening in the drainage lumen or proximal portion of the drainage tube, as such an opening may reduce the negative pressure in the distal portion of the ureteral catheter, thereby reducing the fluid or urine withdrawn or drained from the kidneys and renal pelvis. Ideally, the catheter blocks the ureter and/or kidney without preventing fluid flow from the ureter and/or kidney. Further, while not wishing to be bound by any theory, it is believed that when negative pressure is applied proximal to the proximal portion of the drainage lumen, ureter tissue may be drawn over or into the opening along the proximal portion of the drainage lumen, which may irritate the tissue.

Some embodiments of ureteral catheters, according to the present invention, include a positioning portion having a funnel stent, as shown in fig. 1-7, 27-34, 40-57B. As shown in fig. 1-3E, 27-34, the funnel support is formed from a coil. Other embodiments of the funnel holder are shown in figures 4A-7, 40-57B. Each of the funnel supports according to the present invention will be discussed in detail below.

In some embodiments, as shown in fig. 41A-C, a distal portion 5004 of a ureteral catheter, generally designated 5000, is shown. The distal portion 5004 includes a locating portion 5012, the locating portion 5012 having a funnel holder 5014. The funnel holder 5014 has at least one side wall 5016. The at least one side wall 5016 of the funnel support 5014 has a first diameter (outer diameter) D4 and a second diameter (outer diameter) D5, and the first outer diameter D4 is less than the second outer diameter D5. The second outer diameter D5 of the funnel stent 5014 is closer to the distal end 5010 of the distal portion 5004 of the drainage lumen 5002 than the first outer diameter D4. In some embodiments, the first outer diameter D4 may be about 0.33mm to 4mm (about 1Fr to about 12Fr (french catheter scale)), or about (2.0 ± 0.1) mm. In some embodiments, the second outer diameter D5 is greater than the first outer diameter D4, and may be about 1mm to about 60mm, or about 10mm to 30mm, or about (18 ± 2) mm.

In some embodiments, the at least one side wall 5016 of the funnel holder 5014 can also have a third diameter D7 (as shown in fig. 41B), and the third diameter D7 is less than the second outer diameter D5. The third diameter D7 of the funnel stent 5014 is closer to the distal end 5010 of the distal portion 5004 of the drainage lumen 5002 than the second diameter D5. The third diameter D7 will be discussed in more detail below with respect to the lip. In some embodiments, the third diameter D7 may be about 0.99mm to about 59mm, or about 5mm to about 25 mm.

The at least one side wall 5016 of the funnel holder 5014 has a first diameter (inner diameter) D6. The first inner diameter D6 is closer to the proximal end 5017 of the funnel holder 5014 than the third diameter D7. The first inner diameter D6 is less than the third diameter D7. In some embodiments, the first inner diameter D6 is about 0.05mm to 3.9mm, or about (1.25 ± 0.75) mm.

In some embodiments, the side walls 5016 can have an overall height H5 along the central axis 5018 of the locating portion 5012 of from about 1mm to about 25 mm. In some embodiments, for example, if the sidewall has a wavy or rounded edge (e.g., as shown in fig. 47), the height H5 of different portions of the sidewall may vary. In some embodiments, the fluctuation range can be about 0.01mm to about 5mm or more, if desired.

As shown in fig. 4A-7, 41A-B, 43, 44, 45A, 46A, 47, 48, 49, 50, 51, 52, 53, 54, 55-57B, the funnel support 5014 can be generally conical. In some embodiments, the angle 5020 between the outer wall 5022 near the proximal end 5017 of the funnel holder 5014 and the drainage lumen 5002 adjacent to the base 5024 of the funnel holder 5014 can be about 100 degrees to about 180 degrees, or about 100 degrees to about 160 degrees, or about 120 degrees to about 130 degrees. The angle 5020 can vary with location on the perimeter of the funnel holder 5014, for example as shown in fig. 45A, where the angle 5020 is about 140 degrees to about 180 degrees.

In some embodiments, the edge or lip 5026 of the distal end 5010 of the at least one sidewall 5016 can have a rounded, squared off, or any desired shape. The shape defined by the rim 5026 can be, for example, circular (as shown in fig. 41C, 46B), oval (as shown in fig. 45B), split (as shown in fig. 51B, 52B, 53B), square, rectangular, or any desired shape.

Fig. 51A-53B illustrate a funnel support 5300, wherein the at least one sidewall 5302 has a plurality of split-shaped longitudinal pleats 5304 along a length L7 of the sidewall 5302. From 2 to about 20 pleats 5304 can be provided, or as shown about 6 pleats 5304. In this embodiment, the pleats 5304 can be made of one or more flexible materials (e.g., silicone, polymer, solid material, fabric, or permeable mesh) to achieve the desired lobe shape. Pleat 5304 can be substantially circular, as shown in cross-sectional view 51B. The depth D10 of each pleat 5304 at the distal end 5306 of the funnel support 5300 can be the same or different, and can be about 0.5mm to about 5 mm.

As shown in fig. 52A, 52B, one or more pleats 5304 can have at least one longitudinal support 5308. The longitudinal support 5308 can extend over all or a portion of the length L7 of the funnel support 5300. The longitudinal support 5308 can be made of a flexible but partially rigid material, such as a temperature sensitive shape memory material such as nitinol. The thickness of the longitudinal support 5308 can be about 0.01mm to about 1mm, as desired. In some embodiments, the nitinol frame may be covered with a suitable water resistant material, such as silicon, to form a cone or funnel. In this case, liquid is allowed to flow down the inner surface 5310 of the funnel support 5300 and into the drainage lumen 5312. In other embodiments, pleat 5304 is made of various rigid or partially rigid sheets or materials that are bent or molded into a funnel-shaped positioning portion.

As shown in fig. 53A, 53B, the distal end or edge 5400 of the pleat 5402 can have at least one edge support 5404. The edge support 5404 can extend over all or one or more portions of the circumference 5406 of the distal edge 5400 of the funnel support 5408. The edge support 5404 may be made of a flexible but partially rigid material, such as a temperature sensitive shape memory material such as nitinol. The thickness of the edge support 5404 can be about 0.01mm to about 1mm, as desired.

In some embodiments, as shown in fig. 41A-C, the distal end 5010 of the drainage lumen 5002 (or funnel stent 5014) can have an inward lip 5026 towards the center of the funnel stent 5014, the lip 5026 having a thickness of, for example, about 0.01mm to about 1mm to prevent irritation to renal tissue. Thus, the funnel stent 5014 can have a third diameter D7 that is less than the second diameter D5, the third diameter D7 being closer to the end 5010 of the distal portion 5004 of the drainage lumen 5002 than the second diameter D5. The outer surface 5028 of the lip 5026 can have rounded, squared, or any desired shaped edge. The lip 5026 can help provide additional support to the renal pelvis and the infrarenal tissue.

In some embodiments, as shown in fig. 47, an edge 5200 of the distal end 5202 of the at least one side wall 5204 can be shaped. For example, edge 5200 can have a plurality of generally rounded edges 5206 or scallops, such as about 4 to about 20 or more rounded edges. Rounded edge 5206 may have a greater surface area than a straight edge to help support the tissue of the renal pelvis or kidney and prevent obstruction. Edge 5200 can have any shape desired, but preferably has no or substantially no sharp edges to avoid damaging tissue.

In some embodiments, as shown in fig. 41A-C, 45A-46B, the funnel stent 5014 has a base 5024 adjacent to the distal portion 5004 of the drainage lumen 5002. The base 5024 comprises at least one internal port 5030 that aligns with the internal lumen 5032 of the proximal portion 5006 of the drainage lumen 5002 to allow fluid to flow into the internal lumen 5032 of the proximal portion 5006 of the drainage lumen 5002. In some embodiments, the openings 5030 are circular in cross-section, but can have other shapes, such as ellipsoidal, triangular, square, etc.

In some embodiments, as shown in fig. 45A-46B, the central axis 5018 of the funnel holder 5014 is offset from the central axis 5034 of the proximal portion 5006 of the drainage lumen 5002. The central axis 5018 of the funnel holder 5014 can be offset from the central axis 5034 of the proximal portion 5006 by a distance x of from about 0.1mm to about 5 mm.

The diameter D8 (e.g., as shown in fig. 41C, 46B) of the at least one internal port 5030 of the base 5024 is about 0.05mm to about 4 mm. In some embodiments, the diameter D8 of the internal port 5030 of the base 5024 is about equal to the first inner diameter D6 of the adjacent proximal portion 5006 of the drainage lumen.

In some embodiments, the ratio between the height H5 of the at least one side wall 5016 of the funnel support 5014 and the second outer diameter D5 of the at least one side wall 5016 of the funnel support 5014 is about 1: 25 to about 5: 1.

In some embodiments, the diameter D8 of the at least one inner port 5030 of the base 5024 is from about 0.05mm to about 4mm, the height H5 of the at least one side wall 5016 of the funnel holder 5014 is from about 1mm to about 25mm, and the second outer diameter D5 of the funnel holder 5014 is from about 5mm to about 25 mm.

In some embodiments, the thickness T1 (e.g., as shown in fig. 41B) of the at least one side wall 5016 of the funnel holder 5014 can be about 0.01mm to about 1.9mm, or about 0.5mm to about 1 mm. The thickness T1 can be substantially uniform throughout the at least one side wall 5016 or can vary as desired. For example, the thickness T1 of the at least one sidewall 5016 near the distal end 5010 of the distal portion 5004 of the drainage lumen 5002 can be less than or greater than its thickness at the base 5024 of the funnel holder 5014.

As shown in fig. 42-44, the at least one side wall 5016 can be straight (as shown in fig. 18A, 43), convex (as shown in fig. 42), concave (as shown in fig. 44), or any combination thereof along its length. As shown in fig. 42, 44, the curvature of the sidewall 5016 can be approximated by the radius of curvature R of point Q such that a circle centered on Q intersects the curve and has the same slope and curvature as the curve. In some embodiments, the radius of curvature is about 2mm to about 12 mm. In some embodiments, the funnel holder 5014 is generally hemispherical in shape, as shown in fig. 42.

In some embodiments, the at least one side wall 5016 of the funnel support 5014 is formed from a bladder 5100, for example as shown in fig. 5A, 5B, 57A, 57B. Balloon 5100 may be any shape that allows for a funnel stent to prevent blockage of the ureter, renal pelvis, and/or the remainder of the kidney. As shown in fig. 57A, 57B, balloon 5100 is funnel-shaped. The balloon may be inflated after insertion or deflated by adding or subtracting gas or air through the port 5102 before removal. The one or more ports 5102 may simply abut an inner portion 5104 of the balloon 5100, e.g., the balloon 5100 may be adjacent the inner portion 5106, or an outer portion 5108 surrounding an adjacent portion of the proximal portion 5006 of the drainage lumen 5002. The diameter D9 of the side wall 5110 of the balloon 5100 may be about 1mm to about 3mm and may vary along its length such that the side wall has a uniform diameter and tapers toward the distal end 5112 or toward the proximal end 5114 of the funnel support 5116. The outer diameter D10 of the distal end 5112 of the funnel holder 5116 can be about 5mm to about 25 mm.

In some embodiments, the at least one side wall 5016 of the funnel holder 5014 is continuous along its height H5, for example as shown in fig. 41A, 42, 43, 44. In some embodiments, the at least one side wall 5016 of the funnel holder 5014 has a solid wall, e.g., the side wall 5016 is impermeable after 24h of contact with a liquid (e.g., urine) on one side.

In some embodiments, the at least one side wall of the funnel support is discontinuous along its height or body direction. As used herein, "discontinuous" means that the at least one sidewall has at least one opening to allow liquid or urine to flow into the drainage lumen through the opening, for example, under the influence of gravity or negative pressure. In some embodiments, the openings may be conventional openings through the sidewall, or openings in a mesh material, or openings in a permeable fabric. The cross-section of the opening may be circular or non-circular, such as rectangular, square, triangular, polygonal, ellipsoidal, as desired. In some embodiments, "opening" refers to a gap between adjacent coils in a positioning of a conduit (including a coil or delivery tube).

As used herein, "opening" or "aperture" refers to a continuous aperture or channel through a sidewall from the outside to the inside of the sidewall or from the inside to the outside of the sidewall. In some embodiments, each of the at least one or more openings may have the same or different area, and the area may be about 0.002mm²To about 100mm²Or about 0.002mm²To about 10mm². As used herein, the "area" or "surface area" or "cross-sectional area" of an opening refers to the smallest planar area defined by the perimeter of the opening. For example, if the opening is circular and the diameter outside the sidewall is about 0.36mm (0.1 mm area)²) But only 0.05mm in diameter (0.002 mm in area) at some point within or on opposite sides of the sidewall²) Then the "area" would be 0.002mm²Since this is the smallest planar area through which liquid flows from the openings in the side walls. If the opening is square or rectangular, the "area" is equal to the length multiplied by the width of the planar area. For any other shape, the "area" may be determined by conventional mathematical calculations well known to those skilled in the art. For example, by fitting shapes to fill the planar area of the opening, and calculating the area of each shape and adding those areas, one may obtainThe "area" of the regularly shaped opening.

In some embodiments, at least a portion of the sidewall includes at least one opening(s). Typically, the central axis of the opening may be generally perpendicular to the planar outer surface of the sidewall, or the opening may be at an angle relative to the planar outer surface of the sidewall. The hole size of the opening may be uniform throughout its depth direction, or its width may vary in the depth direction, and the width of the opening passing through from the outer surface of the side wall to the inner surface of the side wall may increase, decrease, or alternately increase and decrease.

In some embodiments, at least a portion of the sidewall has at least one opening(s), as described in fig. 3A-3E, 30A, 30E, 31-34, 50, 54A, 54B, 55, 56. The opening may be located anywhere along the side wall. For example, the openings may be uniformly located throughout the sidewall, or in a particular region of the sidewall, such as closer to the distal end of the sidewall or closer to the proximal end of the sidewall, or grouped vertically, horizontally, or randomly along the length or perimeter of the sidewall. While not wishing to be bound by any theory, it is believed that when negative pressure is applied proximal to the proximal portion of the drainage lumen, openings in the proximal portion of the funnel stent in close proximity to the ureter, renal pelvis, and/or other renal tissue may be undesirable because the openings therein may reduce the negative pressure in the distal portion of the ureteral catheter, thereby reducing fluid or urine aspirated or drained from the kidney and renal pelvis, and may also irritate the tissue.

As desired, 1 to 1000 or more openings may be provided. For example, six openings (three on each side) are shown in fig. 50. As described above, in some embodiments, each of the at least one or more openings may have an area that may be the same or different, and the area may be about 0.002mm²To about 50mm²Or about 0.002mm²To about 10mm²。

In some embodiments, as shown in fig. 50, the opening 5500 may be closer to the distal end 5502 of the sidewall 5504. In some embodiments, the one or more openings are located in a distal half 5506 of the sidewall toward the distal end 5502. In some embodiments, openings 5500 are evenly distributed about the circumference of distal half 5506, even closer to distal end 5502 of sidewall 5504.

In contrast, as shown in fig. 54B, the opening 5600 is positioned near the proximal end 5602 of the inner lateral wall 5604 and does not directly contact tissue because the outer lateral wall 5606 is positioned between the opening 5600 and tissue. Alternatively or additionally, one or more openings 5600 can be located near a distal end of the inner sidewall, as desired. The lateral side 5610 of the medial side wall 5604 can be joined to one or more struts 5608 or ridges of the medial side 5612 of the lateral side wall 5606, thereby joining the medial side wall 5604 and the lateral side wall 5606.

In some embodiments, for example as shown in fig. 48, 49, the at least one

sidewall

5700, 5800 of the

funnel support

5702, 5802 has a

mesh

5704, 5804. The

meshes

5704, 5804 have a plurality of

openings

5706, 5806 therethrough to allow fluid to flow into the

drainage lumens

5708, 5808. In some embodiments, the maximum area of the opening may be less than about 100mm²Or less than about 1mm²Or about 0.002mm²To about 1mm²Or about 0.002mm²To about 0.05mm². The

meshes

5704, 5804 can be made of any suitable metal or polymeric material, as described above.

In some embodiments, the funnel support further comprises a cover over a distal end thereof. The cover may be integral with the funnel support or attached to the distal end of the funnel support. For example, as shown in fig. 49, funnel support 5802 includes a cover 5810 that passes over and extends from a distal end 5812 of funnel support 5802. Cover 5810 may have any desired shape, such as flat, convex, concave, wavy, and combinations thereof. The cover 5810 may be made of a mesh as described above or any polymeric solid material. Cover 5810 may help support soft tissue in the renal area to promote urine production.

In some embodiments, the funnel support comprises a porous material, for example as shown in fig. 6, 7. Fig. 6, 7 and suitable porous materials are described in detail below. In brief, in fig. 6 and 7, the porous material itself is the funnel support. In fig. 6, the funnel support is a wedge made of a porous material. In fig. 7, the porous material is funnel-shaped. In some casesIn an embodiment, such as shown in fig. 55, a porous material 5900 is located within the interior 5902 of the sidewall 5904. In some embodiments, as shown, for example, in fig. 56, the funnel holder 6000 has a porous liner 6002 adjacent an interior 6004 of a sidewall 6006. The porous pad 6002 may have a thickness T2 of, for example, about 0.5mm to about 12.5 mm. The area of the openings in the porous material may be about 0.002mm²To about 100mm²Or smaller.

In some embodiments, a ureteral catheter with a funnel stent may be deployed in the patient's urinary tract (more specifically, in the renal pelvis area/kidney) using a catheter that passes through the urethra and into the bladder. The funnel stent 6100 is in a collapsed state (as shown in fig. 58) and is nested within the ureteral sheath 6102. To deploy the ureteral catheter, medical personnel insert a cystoscope into the urethra to provide access to the bladder for the tool. The ureteral orifice is visualized and a guide wire is passed through the cystoscope and ureter until the tip of the guide wire reaches the renal pelvis. The cystoscope may be removed and a "push tube" is sent over the guidewire to the renal pelvis. The guidewire may be removed while the "push tube" stays in place to act as a sheath for deployment. The ureteral catheter is passed through a pusher/sheath, and once the catheter tip extends from the end of the pusher/sheath, the catheter tip will be able to move. The funnel stent will expand radially to assume a deployed position.

In some embodiments, as shown in fig. 27-30, positioning portion 1230 is integral with tube 1222. In other embodiments, positioning portion 1230 may comprise a separate tubular member connected to and extending from tube or drainage lumen 1224.

In some embodiments, the locator comprises a plurality of radially extending coils. These coils are funnel-shaped, forming a funnel support. Some embodiments of the coil funnel support are shown in fig. 1-3E, 27-34.

In some embodiments, the at least one sidewall of the funnel support comprises at least a first coil having a first diameter and a second coil having a second diameter, and the first diameter is less than the second diameter, wherein a maximum distance between a portion of the sidewall of the first coil and a portion of an adjacent sidewall of the second coil is about 0mm to about 10 mm. In some embodiments, the first diameter of the first coil is about 1mm to about 10mm and the second diameter of the second coil is about 5mm to about 25 mm. In some embodiments, the diameter of the coil gradually increases toward the distal end of the drainage lumen such that the helical structure has a tapered or partially tapered configuration.

In some embodiments, the at least one sidewall of the funnel stent has an inward side and an outward side, the inward side having at least one opening that allows fluid to flow into the drainage lumen, and the outward side having no or substantially no openings, as described below. In some embodiments, the at least one opening has an area of about 0.002mm²To about 100mm²。

In some embodiments, the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow liquid to flow into the drainage lumen.

In some embodiments, the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least two openings that allow liquid to flow into the drainage lumen.

In some embodiments, the sidewall of the first coil has a radially inward side and a radially outward side, and the radially outward side of the first coil is free or substantially free of one or more openings.

In some embodiments, the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow liquid to flow into the drainage lumen, and the radially outward side is free or substantially free of one or more openings.

In some embodiments, as shown in fig. 27-34, the distal portion 1218 has an open distal end 1220 to draw fluid into the drainage lumen 1224. The distal portion 1218 of the ureteral catheter 1212 also includes a positioning portion 1230 to secure the distal portion 1218 of the drainage lumen or tube 1222 in the ureter and/or kidney. In some embodiments, the locator comprises a plurality of radially extending

coils

1280, 1282, 1284. The positioning portion 1230 can be flexible and bendable to allow positioning of the positioning portion 1230 in the ureter, renal pelvis, and/or kidney. For example, it is desirable that the positioning portion 1230 be sufficiently bendable to absorb forces exerted on the catheter 1212 and prevent such forces from being transmitted to the ureter. Furthermore, if positioning portion 1230 is pulled in a proximal direction P (as shown in fig. 27, 28) toward bladder 10 of the patient, positioning portion 1230 can be sufficiently flexible to begin straightening and thus can be pulled through

ureters

6, 8. In some embodiments, positioning portion 1230 is integral with tube 1222. In other embodiments, positioning portion 1230 may comprise a separate tubular member connected to and extending from tube or drainage lumen 1224. In some embodiments, catheter 1212 includes an occlusion band 1234 (shown in fig. 29) on tube 1222 proximal of positioning portion 1230. During deployment of catheter 1212, the stop band 1234 is visible by fluorescence imaging. In particular, a user may monitor the passage of the belt 1234 through the urinary tract by fluoroscopy to determine when the positioning portion 1230 has reached the renal pelvis and is ready to deploy.

In some embodiments, positioning portion 1230 includes perforations, drainage ports, or openings 1232 on the sidewall of tube 1222. As described herein, the location and size of the openings 1232 may vary depending on the desired volumetric flow rate of each opening and the size constraints of the positioning portion 1230. In some embodiments, the opening 1232 has a diameter of about 0.05mm to about 2.5mm and an area of about 0.002mm²To 5.00mm². The openings 1232 may be arranged in any direction (e.g., longitudinally and/or axially) desired on the sidewall of the tube 1222. In some embodiments, the spacing between the openings 1232 may be about 1.5mm to about 15 mm. Fluid enters the drainage lumen 1224 through one or more perforations, drainage ports or openings 1232. Desirably, the openings 1232 are positioned in a manner such that when negative pressure is introduced in the drainage lumen 1224, the openings 1232 are not occluded by the

ureters

6, 8 or tissue of the kidney. For example, as described herein, the openings 1232 can be located on the interior of the coil or other structure of the positioning portion 1230 to avoid clogging the openings 1232. In some embodiments, the intermediate portion 1226 and the proximal portion 1228 of the tube 1222 can be absent or substantially absentThere are perforations, ports or openings to avoid plugging of the openings distributed along these portions of the tube 1222. In some embodiments, the

portions

1226, 1228 that are substantially free of perforations or openings have substantially fewer openings than other portions of the tube 1222. For example, the total area of the openings 1232 of the distal portion 1218 can be greater than or significantly greater than the total area of the openings of the proximal and/or

distal portions

1226, 1228 of the tube 1222.

In some embodiments, the openings 1232 are sized and spaced to improve the flow of liquid through the positioning portion 1230. In particular, the inventors have discovered that when negative pressure is introduced in the drainage lumen 1224 of the catheter 1212, most of the liquid will be drawn into the drainage lumen 1224 through the nearest perforation or opening 1232. To improve flow dynamics so that liquid can also be received through the more distal openings of tube 1222 and/or open distal end 1220, a larger size or greater number of openings can be provided at the distal end of positioning portion 1230. For example, the total area of openings 1232 on a length of tube 1222 near the proximal end of positioning portion 1230 may be less than the total area of openings 1232 on a similar length of tube 1222 near open distal end 1220 of tube 1222. In particular, it may be desirable for the liquid drawn into the drainage lumen 1224 through a single opening 1232 or a small number of openings 1232 near the proximal end of the positioning portion 1230 to account for less than 90%, and preferably less than 70%, and more preferably less than 55% of the flow distribution through the drainage lumen 1224.

In many embodiments, the opening 1232 is generally circular in shape, although it may also be triangular, oval, square, diamond, etc. in shape. Further, as will be appreciated by one of ordinary skill in the art, the shape of the opening 1232 may change as the tube 1222 transitions between the uncoiled or elongated position and the coiled or deployed position. It is noted that although the shape of the opening 1232 may vary (e.g., the orifice may be circular in one location and slightly elongated in another location), the area of the opening 1232 in the elongated or uncoiled position is substantially close to its area in the deployed or coiled position.

In some embodiments, the drainage lumen 1224 defined by the tube 1222 includes: distal portion 1218 (e.g., the portion of tube 1222 located in

ureters

6, 8 and

renal pelvis

20, 21, as shown in fig. 27-29); a middle portion 1226 (e.g., the portion of tube 1222 that extends from the distal portion through ureteral opening 16 into bladder 10 and urethra 12 of the patient, as shown in fig. 27-29); and a proximal portion 1228 (e.g., the portion of tube 1222 that extends from urethra 12 to an external fluid collection reservoir and/or pump 2000). In a preferred embodiment, the proximal and

middle portions

1228, 1226 of the tube 1222 have an overall length of about (54 ± 2) cm. In some embodiments, the middle and

proximal portions

1226, 1228 of the tube 1222 include distance markings 1236 (shown in fig. 29) on the sidewalls of the tube 1222 that can be used to determine the insertion depth of the tube 1222 in the patient's urinary tract during deployment of the catheter 1212.

As shown in fig. 27-39D, the exemplary ureteral catheter 1212 includes at least one elongate body or tube 1222 that defines or includes one or more drainage channels or lumens therein, such as drainage lumen 1224. Tube 1222 may be sized from about 1Fr to about 9Fr (french catheter scale). In some embodiments, the outer diameter of tube 1222 may be from about 0.33mm to about 3.0mm, and the inner diameter may be from about 0.165mm to about 2.39 mm. In one embodiment, tube 1222 is 6Fr and has an outer diameter of (2.0 ± 0.1) mm. The length of tube 1222 can be from about 30cm to about 120cm depending on the age (e.g., child or adult) and gender of the patient.

Tube 1222 can be made of a flexible and/or deformable material to facilitate advancement and/or positioning of tube 1222 within bladder 10 and ureters 6, 8 (as shown in fig. 27, 28). For example, tube 1222 may be made of a biocompatible polymer, polyvinyl chloride, polytetrafluoroethylene (PTFE, e.g., PTFE)

) Silicon-coated latex or silicone. In one embodiment, tube 1222 is made of thermoplastic polyurethane. Tube 1222 may also contain or be impregnated with one or more substances of copper, silver, gold, nitinol, stainless steel, and titanium. In some embodiments, tube 1222 is impregnated with or made of a material that is visible by fluorescence imaging. For example, the biocompatible polymer forming tube 1222 may be impregnated with a radiopaque material such as barium sulfate. Thus, the structure and position of tube 1222 is visible for fluoroscopyIn (1).

Spiral coil pipe positioning part

As shown in fig. 30A-30E, exemplary positioning portion 1230 includes

spiral coils

1280, 1282, 1284. In some embodiments, the positioning portion 1230 includes a first coiled or half-coiled tube 1280 and two full-coiled tubes, such as a second coiled tube 1282 and a third coiled tube 1284. As shown in fig. 30A-30D, in some embodiments, the first coil comprises a half coil extending from 0 degrees to 180 degrees around the curvilinear central axis a of the positioning portion 1230. In some embodiments, as shown, the curvilinear central axis a is substantially straight and coextensive with the curvilinear central axis of the tube 1222. In other embodiments, the curvilinear central axis a of the positioning portion 1230 may be curved such that the positioning portion 1230 is conical. First coil 1280 may have a diameter D1 of about 1mm to 20mm, and preferably about 8mm to 10 mm. The second coil 1282 may be a full coil extending from 180 degrees to 540 degrees along the positioning portion 1230, with a diameter D2 of about 5mm to 50mm, preferably about 10mm to 20mm, and more preferably about (14 ± 2) mm. The third coil 1284 may be a full coil extending in the range of 540 and 900 degrees and having a diameter D3 of 5mm to 60mm, preferably about 10mm to 30mm, more preferably about (18 + -2) mm. In other embodiments, the

multiple coils

1282, 1284 may have the same inner and/or outer diameter. For example, the outer diameter of the

full coils

1282, 1284 may each be about (18 ± 2) mm.

In some embodiments, the total height H1 of positioning portion 1230 is about 10mm to about 30mm, and preferably about (18 ± 2) mm. The height H2 of the gap between coils 1284 (i.e., between the sidewall of tube 1222 of a first coil 1280 and the adjacent sidewall of tube 122 of a second coil 1282) is less than 3.0mm, preferably about 0.25mm to 2.5mm, more preferably about 0.5mm to 2.0 mm.

The positioning portion 1230 can also include a distal-most bend 1290. For example, the distal-most portion 1290 of the positioning portion 1230 (including the open distal end 1220 of the tube 1222) may be bent inwardly relative to the curvature of the third coil 1284. For example, curvilinear central axis X1 of distal-most portion 1290 (as shown in fig. 30D) may extend from distal end 1220 of tube 1222 to curvilinear central axis a of positioning portion 1230.

The positioning portion 1230 is transitionable between a collapsed position, wherein the positioning portion 1230 is straight to enable insertion into a patient's urinary tract, and an expanded position, wherein the positioning portion 1230 comprises a

helical coil

1280, 1282, 1284. Generally, tube 1222 is naturally biased toward a coiled configuration. For example, an uncoiled or substantially straight guidewire can be passed through the positioning portion 1230 to maintain the positioning portion 1230 in its straight, contracted position, as shown, for example, in figures 31-35. As the guidewire is withdrawn, positioning portion 1230 naturally transitions to its coiled position.

In some embodiments, the openings 1232 are disposed only or substantially only on the radially inward sides 1286 of the

coils

1280, 1282, 1284 to prevent the openings 1232 from being blocked or obstructed. There may be substantially no openings 1232 on the radially outward side 1288 of the

coils

1280, 1282, 1284. In a similar embodiment, the total area of the openings 1232 on the radially inward side 1286 of the positioning portion 1230 can be significantly greater than the total area of the openings 1232 on the radially outward side 1288 of the positioning portion 1230. Thus, when negative pressure is introduced in the ureter and/or renal pelvis, mucosal tissue of the ureter and/or kidney may be drawn against the positioning portion 1230 and may occlude some of the openings 1232 on the outer circumference of the positioning portion 1230. However, when these tissues contact the outer circumference of the positioning portion 1230, the openings 1232 on the radially inward side 1286 of the positioning portion 1230 are not significantly blocked. Thus, the risk of damage to the tissue due to squeezing or contact with the drainage openings 1232 may be reduced or eliminated.

Hole or opening distribution embodiments

In some embodiments, the first coil 1280 may be devoid or substantially devoid of openings. For example, the total area of the openings on the first coil 1280 can be less than or substantially less than the total area of the openings of the

full coils

1282, 1284. Various arrangements of openings or openings 1332 that may be used for coiled positioners (e.g., coiled positioners 1230 as shown in figures 30A-30E) are shown in figures 31-34. As shown in fig. 31-34, the positioning portion is in its uncoiled or straight position, as when a guidewire is passed through the drainage lumen.

Fig. 31 shows an exemplary positioning section 1330. To more clearly describe the location of the opening of the positioning portion 1330, the positioning portion 1330 is herein divided into a plurality of sections or perforated sections, such as a nearest or first section 1310, a second section 1312, a third section 1314, a fourth section 1316, a fifth section 1318, and a farthest or sixth section 1320. One of ordinary skill in the art will appreciate that additional sections may also be included if necessary. As used herein, "segment" refers to the segmentation of tube 1322 within positioning portion 1330. In some embodiments, the segments are equal in length. In other embodiments, some sections may have the same length, while other sections may have different lengths. In other embodiments, each section has a different length. For example, the length of the segments, L1-L6, may be about 5mm to about 35mm, and preferably about 5mm to 15 mm.

In some embodiments, each section has one or more openings. In some embodiments, each section has a single opening 1332. In other embodiments, the first section 1310 has a single opening 1332, while other sections have multiple openings 1332. In other embodiments, different sections have one or more openings 1332, and each opening has a different shape or a different total area.

In some embodiments, such as in the positioning portion 1230 shown in fig. 30A-30E, the first coil or half-coil 1280 extends from 0 degrees to about 180 degrees of the positioning portion 1230 and may be free or substantially free of openings. The second coiled tube 1282 may include a first section 1310 that extends between about 180 degrees to 360 degrees. The second coiled tube 1282 may also include a second section 1312 and a third section 1314 located between about 360 to 540 degrees of the positioning portion 1230. Third coil 1284 may include fourth section 1316 and fifth section 1318 located between approximately 540 and 900 degrees of positioning portion 1230.

In some embodiments, the size of the opening 1332 may be such that the total area of the openings of the first section 1310 is less than the total area of the openings of the adjacent second section 1312. Similarly, if the positioning portion 1330 further includes the third section 1314, the total area of the openings of the third section 1314 may be greater than the total area of the openings of the first section 1310 or the second section 1312. The total area of the openings and/or the number of openings of the fourth section 1316, the fifth section 1318 and the sixth section 1320 may also be gradually increased to improve the flow conditions of the liquid in the tube 1222.

As shown in fig. 31, the tube positioning portion 1230 includes five

sections

1310, 1312, 1314, 1316, 1318, each section having a

single opening

1332, 1334, 1336, 1338, 1340. Positioning portion 1230 further includes a sixth section 1320 that includes an open distal end 1220 of tube 1222. In the present embodiment, the opening 1232 of the first section 1310 has the smallest total area. For example, the total area of the openings 1332 of the first section may be about 0.002mm²To about 2.5mm²Or alternatively about 0.01mm²To 1.0mm²Or about 0.1mm²To 0.5mm². In one embodiment, the opening 1332 is about 55mm from the distal end 1220 of the catheter, with a diameter of 0.48mm and an area of 0.18mm². In this embodiment, the total area of the openings 1334 of the second section 1312 is greater than the total area of the openings 1332 of the first section 1310, and may range in size from about 0.01mm²To 1.0mm². The size range of the third opening 1336, the fourth opening 1338, and the fifth opening 1350 may also be about 0.01mm²To 1.0mm². In one embodiment, the opening 1334 is about 45mm from the distal end of the catheter 1220, about 0.58mm in diameter, and about 0.27mm in area². The third opening 1336 may be about 35mm from the distal end of the catheter 1220 and about 0.66mm in diameter. Fourth opening 1338 may be about 25mm from distal end 1220 and about 0.76mm in diameter. The fifth opening 1340 may be about 15mm from the distal end 1220 of the catheter and may be about 0.889mm in diameter. In some embodiments, the open distal end 1220 of tube 1222 is open at a maximum, with an area of about 0.5mm²To about 5.0mm²Or larger. In one embodiment, the open distal end 1220 is about 0.97mm in diameter and about 0.74mm in area²。

As described herein, the positions and dimensions of the

openings

1332, 1334, 1336, 1338, 1340 are such that when negative pressure is introduced in the drainage lumen 1224 of the catheter 1212, the volumetric flow rate of liquid flowing through the first opening 1332 more closely corresponds to the volumetric flow rate of liquid flowing through the openings of the more distal sections. As described above, if the area of each opening is equal, when negative pressure is introduced in the drainage lumen 1224, the volumetric flow rate of liquid flowing through the nearest first opening 1332 will be significantly greater than the volumetric flow rate of liquid flowing through the opening 1334 closer to the distal end 1220 of the positioning portion 1330. While not wishing to be bound by any theory, it is believed that when negative pressure is introduced, the pressure differential between the interior and exterior of the drainage lumen 1224 is greater in the region of the proximal opening and smaller at the opening closer to the distal end of the tube. For example, the size and location of the

openings

1332, 1334, 1336, 1338, 1340 can be selected so that the volumetric flow rate of liquid flowing into the opening 1334 of the second section 1312 is at least about 30% of its volumetric flow rate flowing into the opening 1332 of the first section 1310. In other embodiments, the volumetric flow rate of liquid into the proximal-most or first section 1310 is less than about 60% of the total volumetric flow rate of liquid flowing through the proximal portion of the drainage lumen 1224. In other embodiments, when negative pressure, e.g., about-45 mmHg, is introduced at the proximal end of the drainage lumen, the volumetric flow rate of liquid flowing into the

openings

1332, 1334 of the two nearest sections (e.g., the first and second sections 1310, 1312) may be less than about 90% of the volumetric flow rate of liquid flowing through the proximal portion of the drainage lumen 1224.

It will be appreciated by those of ordinary skill in the art that the volumetric flow rate and distribution of a conduit or tube having a plurality of openings or perforations can be directly measured or calculated in different ways. As used herein, "volumetric flow rate" refers to the actual measured volumetric flow rate downstream of and near each opening, or the volumetric flow rate obtained using the "calculate volumetric flow rate" method described below.

For example, actual measurements of the amount of dispersion over time may be used to determine the volumetric flow rate of liquid through each

opening

1332, 1334, 1336, 1338, 1340. In an exemplary experimental arrangement, a multi-chamber container having separate chambers (sized to allow it to receive

sections

1310, 1312, 1314, 1316, 1318, 1320 of positioning portion 1330) may be used to seal and enclose positioning portion 1330. Each

opening

1332, 1334, 1336, 1338, 1340 may be sealed in one of the chambers. When negative pressure is introduced, the amount of liquid drawn into the tube 3222 from the various chambers through each

opening

1332, 1334, 1336, 1338, 1340 can be measured to determine the amount of liquid drawn into each opening over time. The cumulative amount of liquid collected in the tube 3222 by the negative pressure pump system will equal the sum of the liquid drawn into each

opening

1332, 1334, 1336, 1338, 1340.

Alternatively, the volumetric flow rates at which the liquid flows through the

different openings

1332, 1334, 1336, 1338, 1340 can be mathematically calculated using equations that model the flow conditions of the liquid in the tubular body. For example, the volumetric flow rate of liquid flowing into the drainage lumen 1224 through the

openings

1332, 1334, 1336, 1338, 1340 can be calculated based on mass transfer shell balance assessment, as detailed below in connection with the mathematical embodiments and fig. 35A-35C. The derivation of the mass balance equations and the calculation of the flow distribution or volumetric flow rate between the

openings

1332, 1334, 1336, 1338, 1340 are also detailed below in conjunction with fig. 35A-35C.

Another exemplary locating portion 2230 having

openings

2332, 2334, 2336, 2338, 2340 is shown in fig. 32. As shown in fig. 32, the positioning portion 2230 has a number of smaller perforations or

openings

2332, 2334, 2336, 2338, 2340. Each of the

openings

2332, 2334, 2336, 2338, 2340 can have a substantially equal cross-sectional area. As shown in fig. 32, positioning portion 2330 includes six

sections

2310, 2312, 2314, 2316, 2318, 2320 as described above, with each section having a plurality of

openings

2332, 2334, 2336, 2338, 2340. In the embodiment shown in fig. 32, the number of

openings

2332, 2334, 2336, 2338, 2340 of each section increases toward the distal end 1220 of the tube 1222 such that the total area of the openings 1332 in each section increases as compared to the proximal adjacent portion.

As shown in fig. 32, opening 2332 of first section 2310 is disposed along a first imaginary line V1, which first imaginary line V1 is substantially parallel to curvilinear central axis X1 of locator 2230. The

openings

2334, 2336, 2338, 2340 of the second, third, fourth and

fifth sections

2312, 2314, 2316 and 2318, respectively, are positioned in progressively increasing rows on the sidewall of the tube 2222 such that the

openings

2334, 2336, 2338, 2340 of these sections are also arrayed about the circumference of the tube 2222. For example, some of the openings 2334 of the second section 2312 are positioned such that a second imaginary line V2 extending circumferentially around the sidewall of the tube 2222 contacts at least a portion of the plurality of openings 2334. For example, the second section 2312 may include two or more rows of perforations or openings 2334, with each opening 2334 having an equal cross-sectional area. Further, in some embodiments, at least one row of the second sections 2312 may be aligned along a third imaginary line V3, which imaginary line V3 is parallel to the curvilinear central axis X1 of the tube 2222, but is not coextensive with the first imaginary line V1. Similarly, the third section 2314 may include five rows of perforations or openings 2336, with each opening 2336 having an equal cross-sectional area; the fourth section 2316 may include seven rows of perforations or openings 2338; the fifth section 2318 may include nine rows of perforations or openings 2340. As in the previous embodiment, the sixth section 2320 has a single opening, the open distal end 2220 of the tube 2222. In the embodiment shown in fig. 32, each opening has an equal area, but the area of one or more openings may be unequal, if desired.

Another exemplary locator 3230 having

openings

3332, 3334, 3336, 3338, 3340 is shown in fig. 33. The positioning portion 3230 in fig. 33 has a plurality of closely sized perforations or

openings

3332, 3334, 3336, 3338, 3340. As described in the previous embodiments, the positioning portion 3230 can be divided into six

sections

3310, 3312, 3314, 3316, 3318, 3320, and each section has at least one opening. The proximal or first section 3310 has an opening 3332. The second section 3312 has two openings 3334 aligned along dashed line V2, and dashed line V2 extends around the circumference of the sidewall of tube 3222. Third section 3314 has a set of three openings 3336 located at the vertices of an imaginary triangle. The fourth section 3316 has a set of four openings 3338 located at the corners of the dashed square. The fifth section 3318 has ten openings 3340 that are positioned in a diamond shape on the sidewall of the tube 3222. As with the previous embodiments, the sixth section 3320 has a single opening, the open distal end 3222 of the tube 3220. The area of each opening may be about 0.001mm²To about 2.5mm²。

Another exemplary locator 4230 having

openings

4332, 4334, 4336, 4338, 4340 is shown in fig. 34. The

openings

4332, 4334, 4336, 4338, 4340 of the positioning portions 4330 have different shapes and sizes. For example, the first section 4310 has a single circular opening 4332. The second section 4312 has a circular opening 4334, the circular opening 4334 being compared to the opening 433 of the first section 43102 have a larger cross-sectional area. The third section 4314 has three triangular openings 4336. The fourth section 4316 has a large circular opening 4338. The fifth section 4318 has a diamond shaped opening 4340. As with the previous embodiments, the sixth section 4320 comprises an open distal end 4220 of a tube 4222. FIG. 34 illustrates one embodiment of an arrangement of differently shaped openings in each section. It is understood that the shape of each opening in each section can be independently selected, for example, the first section 4310 can have one or more diamond-shaped openings or other shaped openings. The area of each opening may be about 0.001mm²To about 2.5mm²。

Examples

Calculation of volumetric flow rate and percent flow distribution

Having described various arrangements of the openings of the positioning portion of the ureteral catheter 1212, the methods for determining the percentage of the calculated flow distribution and calculating the volumetric flow rate as liquid flows through the catheter will be detailed. FIG. 38 is a schematic view of an exemplary catheter with side wall openings showing the position of portions of the tube or drainage lumen used in the following calculations. Calculating the percent flow distribution refers to the percentage of the total liquid that flows through the proximal portion of the drainage lumen in the liquid that enters the drainage lumen through the different openings or segments of the positioning portion. The calculated volumetric flow rate refers to the flow rate of liquid flowing through different portions of the drainage lumen or the opening of the positioning portion per unit time. For example, the volumetric flow rate of the proximal portion of the drainage lumen refers to the flow rate of the total amount of liquid flowing through the catheter. The volumetric flow rate of an opening refers to the volume of liquid that enters the drainage lumen through the opening per unit time. In tables 3-5 below, flow is described as a percentage of the total fluid flow or total volume flow rate proximal to the drainage lumen. For example, an opening with a 100% flow distribution means that all liquid entering the drainage lumen flows through the opening. An opening with a flow distribution of 0% means that all liquid entering the drainage lumen does not flow through the opening.

These volumetric flow rate calculations are used to determine and simulate the flow conditions of liquid flowing through the positioning portion 1230 of the ureteral catheter 1212 shown in fig. 27-34. Furthermore, these calculations show that adjusting the opening area and the linear distribution of the openings along the positioning portion affects the distribution of the liquid flowing through the different openings. For example, reducing the area of the closest opening may reduce the proportion of liquid drawn into the conduit through the closest opening and increase the proportion of liquid drawn into the more distant openings of the locating portion.

The parameters used in the following calculations are a tube length of 86cm, an internal diameter of 0.97mm and an end hole internal diameter of 0.97 mm. The density of urine was 1.03g/mL, and the coefficient of friction at 37 ℃ was 8.02X 10^-3Pa·S(8.02×10^-3kg/s.m). The volumetric flow rate of urine through the catheter was determined by experimental measurements to be 2.7mL/min (Q)_{General assembly})。

The calculated volumetric flow rate is determined by the volumetric mass balance equation, wherein the volumetric flow through all perforations or openings 1232 of the five sections of the positioner (referred to herein as volumetric flow Q)₂To Q₆) In conjunction with the volumetric flow through the open distal end 1220 (referred to herein as volumetric flow Q)₁) The sum of (A) and (B) is equal to the total volumetric flow (Q) exiting from the proximal end of tube 1222 from 10cm to 60cm from the last proximal opening_{General assembly}) As shown in equation 2.

Q_{General assembly}＝Q₁+Q₂+Q₃+Q₄+Q₅+Q₆(equation 2)

The modified loss coefficients (K') for each segment are derived based on the following three loss coefficients within the catheter model: an inlet loss coefficient that accounts for pressure losses that occur at the conduit inlet (e.g., the opening and open distal end of tube 1222); a friction loss coefficient that takes into account the pressure loss due to friction between the liquid and the tube wall; and a junction loss factor that accounts for pressure losses due to the interaction of the two converging streams.

The inlet loss coefficient depends on the shape of the orifice or opening. For example, a tapered or nozzle shaped orifice will increase the flow rate of the liquid as it enters the drainage lumen 1224. Similarly, sharp-edged orifices have different flow characteristics than orifices with less sharp edges. For the purposes of the following calculations, it is assumed that opening 1232 is a side port and that open distal end 1220 of tube 1222 is a sharp-edged opening. The cross-sectional area of each opening through the side wall of the tube is considered to be constant.

The coefficient of friction loss approximates the pressure loss caused by friction between the liquid and the adjacent inner wall of tube 1222. The friction loss is determined according to the following equation:

the junction loss coefficient is obtained from the junction loss coefficient at the branch angle of 90 degrees. The values for the loss coefficients are from graphs 13.10 and 13.11 in "Miller DS, Internal Flow systems, 1990", which is incorporated herein by reference. The ratio of the inlet area (referred to as A1 in the graph) to the conduit cross-sectional area (referred to as A3 in the graph) and the inlet volumetric flow rate (referred to as Q in the graph) are used in these graphs₁) With the resulting total conduit volumetric flow rate (referred to as Q in the graph)₃) The ratio therebetween. For example, if the ratio between the open area and the draft tube lumen area is 0.6, the following junction loss coefficient (K) will be used₁₃And K₂₃)。

In order to calculate the overall manifold loss coefficient (K), it is necessary to divide the model into so-called "reference stations" and to gradually obtain and balance the pressure and flow distributions of the two paths (e.g. the flow through the opening and the flow through the drainage lumen of the tube) to reach each station from the distal tip to the nearest "station". A graphical representation of the different stations used for this calculation is shown in fig. 38. For example, the most distal a "station" is the open distal end 1220 of the tube 122. The second station a' is the furthest opening (e.g., one or more openings of the fifth section 1318 in fig. 31-34) on the sidewall of the tube 122. The next station B is for flowing liquid through the drainage lumen 1224 immediately adjacent the a' opening.

To calculate the loss of liquid entering through the open distal end of tube 1222 (path 1) between station a (distal opening) and station B, the modified loss factor (K') is made equal to:

k ═ inlet loss + friction loss + F junction loss (equation 4.1)

Similarly, the second path to station B passes through opening 1334 of fifth section 1318 of positioning section 1330 (as shown in fig. 31-34). The correction loss coefficient for path 2 is calculated as follows:

k ═ inlet loss + junction loss (equation 5.1)

The correction loss coefficients of path 1 and path 2 must be equal to ensure the volumetric flow rate (Q)₁And Q₂) The equilibrium distribution within the manifold at station B can be reflected. The volumetric flow rate is adjusted until the corrected loss factors for the two paths are equal. The volumetric flow rate can be adjusted because it represents the total volumetric flow rate (Q'_{General assembly}) A minority of (2), and Q'_{General assembly}A one is assumed in this step-by-step solution. After equalizing the two correction loss coefficients, the two paths to the C station (the fourth section 1316 in fig. 31-34) may continue to be equalized.

The loss factor between the B station (flowing through the drainage lumen in the fifth section 1318) and the C station (flowing through the drainage lumen in the fourth section 1316) is calculated in a manner similar to that shown in equations 5.1 and 5.2. For example, for path 1(B station to C station), the modified loss coefficient (K') for the aperture of the fourth section 1316 is determined as:

k ═ loss to B station + friction loss + F junction loss (equation 6.1)

K′_C＝K′_B+K_2-3×(Q₁+Q₂)²+K_2-4×(Q₁+Q₂+Q₃)²(equation 6.2)

For path 2 (B-station to C-station), the modified loss factor (K') for the flow area based on the opening of the fourth section 1316 is determined as:

k ═ inlet loss + junction loss (equation 7.1)

As with the previous stations, the modified loss coefficients for Path 1 and Path 2 must be equal to ensure the volumetric flow rate (Q)₁、Q₂、Q₃) Reflecting an equilibrium distribution within the manifold up to the C station. After equalizing the two correction loss coefficients, the two paths to D station, E station, and F station may continue to be equalized. As shown, a step-by-step solution process is performed for each station until the correction loss factor for the final station (in this case, station F) is calculated. Then, the actual Q determined by experimental measurements can be used_{General assembly}(volumetric flow rate of liquid through the proximal portion of the drainage lumen) to calculate the total loss coefficient (K) of the manifold.

The fractional volumetric flow rate obtained by the step-wise solution may then be multiplied by the actual total volumetric flow rate (Q)_{General assembly}) To determine the flow rate through each opening 1232 (shown in fig. 30A-30E) and open distal end 1220.

Examples

Examples for calculating the volumetric flow rate are provided below, as shown in tables 3-5 and FIGS. 35A-35C.

Example 1

Example 1 shows the liquid flow distribution of positioning tubes with different sized openings, which corresponds to the embodiment of the positioning member 1330 shown in fig. 31. As shown in Table 3, the nearest opening (Q)₆) Is 0.48mm, the most distal opening (Q) on the tube side wall₅) Is 0.88mm and the open distal end (Q) of the tube₆) OfThe diameter is 0.97 mm. Each opening is circular.

The percent flow distribution and the calculated volumetric flow rate are determined as follows.

Route to station B via the distal end of the tube (route 1)

f8.4＝C_f/Re(C_fFor a circular cross-section 64 ═ d

K_{Inlet port}0.16 (coefficient of contraction, sharp-edged orifice for entry into a pipe)

K_Orifice2.8 (coefficient of contraction for sharp-edged orifice with/without outlet pipe)

K_{Friction of}F (L/D) (depending on the length between the orifices)

Fraction 1-1 ═ inlet loss coefficient x (a)_T/A₁×Q'₁)²

Part 1-2 ═ tube friction loss × Q'₁ ²

Segment 1-3 ═ to 2 station through flow knot loss x (Q'₁+Q'₂)²

A₂/A_T＝0.82

Q'₂/(Q’₁+Q’₂)＝0.83

K_1-3Equal to 0.61 (taken from Miller, see table above)

Part 1-1 ═ 0.0000

Part 1-2 ═ 0.0376

Part 1-3 ═ 0.0065

K’＝0.0442

Path to station B via side wall opening (path 2)

Fraction 2-1 ═ orifice loss coefficient x (a)_T/A₂×Q'₂)²

Part 2-2 ═ to 2 station branch stream quench loss x (Q'₁+Q’₂)²

A₂/A_T＝0.82

Q’₂/(Q’₁+Q’₂)＝0.83

K_2-21.3 (Chart 13.10, taken from Miller)

Moiety 2-1 ═ 0.0306

Moiety 2-2 ═ 0.0138

K’＝0.0444

Path from station B to station C (Path 1+ Path 2)

Fraction 2-3 ═ duct frictional loss x (Q'₁+Q'₂)²

Segment 2-4 ═ to 3 station through flow knot loss x (Q'₁+Q'₂+Q’₃)²

A₃/A_T＝0.61

Q’₃/(Q’₁+Q’₂+Q'₃)＝0.76

K_2-4Equal to 0.71 (chart 13.11 taken from Miller)

Loss factor to 2 station is 0.044

Moiety 2-3 ═ 0.921

Moiety 2-4 ═ 0.130

K’＝1.095

Path to C station via side wall opening (path 3)

Fraction 3-1 ═ orifice loss coefficient x (a)_T/A₃×Q’₃)²

Fraction 3-2 ═ to 3 station branch stream quench loss x (Q'₁+Q'₂+Q'₃)²

A₃/A_T＝0.61

Q'₃/(Q’₁+Q'₂+Q'₃)＝0.76

K_3-21.7 (Chart 13.10, taken from Miller)

Moiety 3-1 ═ 0.785

Moiety 3-2 ═ 0.311

K’＝1.096

Path from C station to D station (Path 1+ Path 2+ Path 3)

Fraction 3-3 ═ duct frictional loss x (Q'₁+Q'₂+Q'₃)²

Segment 3-4 ═ to 4 station through flow knot loss x (Q'₁+Q'₂+Q'₃+Q'₄)²

A₄/A_T＝0.46

Q’₄/(Q’₁+Q'₂+Q'₃+Q'₄)＝0.70

K_3-4Not rated 0.77 (chart 13.11, taken from Miller)

Loss factor to 3 stations 1.10

Fraction 3-3 ═ 15.90

Fraction 3-4 ═ 1.62

K’＝18.62

Path to station D via side wall opening (path 4)

Fraction 4-1 ═ orifice loss coefficient x (a)_T/A₄×Q'₄)²

Part 4-2 ═ to 4 station branch stream quench loss x (Q'₁+Q'₂+Q'₃+Q'₄)²

A₄/A_T＝0.46

Q'₄/(Q’₁+Q'₂+Q'₃+Q'₄)＝0.70

K_4-22.4 (Chart 13.10, taken from Miller)

Moiety 4-1 ═ 13.59

Moiety 4-2 ═ 5.04

K’＝18.62

Path from D station to E station (Path 1+ Path 2+ Path 3+ Path 4)

Fraction 4-3 ═ duct frictional loss x (Q'₁+Q'₂+Q'₃+Q'₄)²

Segment 4-4 ═ to 5 station through flow knot loss x (Q'₁+Q'₂+Q'₃+Q'₄+Q'₅)²

A₅/A_T＝0.36

Q'₅/(Q’₁+Q'₂+Q'₃+Q'₄+Q'₅)＝0.65

K_3-4Not rated 0.78 (Chart 13.11, taken from Miller)

Loss factor to 4 stations 18.6

Fraction 4-3 ═ 182.3

Moiety 4-4 ═ 13.3

K’＝214.2

Path to E station via side wall opening (path 5)

Fraction 5-1 ═ orifice loss coefficient x (a)_T/A₅×Q'₅)²

Part 5-2 ═ to 5 station branch stream quench loss x (Q'₁+Q'₂+Q'₃+Q'₄+Q'₅)²

A₅/A_T＝0.36

Q'₅/(Q’₁+Q'₂+Q'₃+Q'₄+Q'₅)＝0.65

K_4-23.3 (Chart 13.10, taken from Miller)

Fraction 5-1 ═ 157.8

Fraction 5-2 ═ 56.4

K’＝214.2

Path from E station to F station (path 1-5)

Fraction 5-3 ═ duct frictional loss x (Q'₁+Q'₂+Q'₃+Q'₄+Q'₅)²

Segment 5-4 ═ to 6 station through flow knot loss x (Q'₁+Q'₂+Q'₃+Q'₄+Q'₅+Q'₆)²

A₆/A_T＝0.24

Q'₆/(Q’₁+Q'₂+Q'₃+Q'₄+Q'₅+Q'₆)＝0.56

K_3-4Not rated 0.77 (chart 13.11, taken from Miller)

Loss factor to 5 station 214.2

Fraction 5-3 ═ 1482.9

Fraction 5-4 ═ 68.3

K’＝1765.4

Path to station F via side wall opening (path 6)

Section 6-1Orifice loss coefficient x (a)_T/A₆×Q'₆)²

Part 6-2 ═ to 6 station branch stream quench loss x (Q'₁+Q’₂+Q'₃+Q'₄+Q'₅+Q'₆)²

A₆/A_T＝0.24

Q'₆/(Q’₁+Q’₂+Q'₃+Q’₄+Q’₅+Q’₆)＝0.56

K_4-2= 5.2 (Chart 13.10, taken from Miller)

Fraction 6-1 ═ 1304.3

Moiety 6-2 ═ 461.2

K’＝1765.5

To calculate the flow distribution for each "station" or opening, the calculated K' value is multiplied by the actual total volumetric flow rate (Q)_{General assembly}) To determine the flow rate through each perforation and distal orifice. Alternatively, the calculation result may be expressed as a percentage of the total flow rate or a flow rate distribution, as shown in table 3. As shown in table 3 and fig. 35C, through the nearest opening (Q)₆) The percentage of flow distribution (% flow distribution) of (c) was 56.1%. Through two nearest openings (Q)₆And Q₅) The flow rate of (2) was 84.6%.

TABLE 3

As shown in example 1, increasing the pore size and cross-sectional area from the proximal to the distal region of the location can result in a more uniform distribution of fluid flow throughout the location.

Example 2

In embodiment 2, each opening has an equal diameter and area. As shown in table 4 and fig. 35A, the flow distribution through the nearest opening in this case was 86.2% of the total flow through the tube. The flow distribution through the second opening was 11.9%. Thus, it was calculated that 98.1% of the fluid flowing through the drainage lumen in this embodiment entered the lumen through the two closest openings. Example 2 increased the flow through the proximal end of the tube compared to example 1. Thus, example 1 achieved a wider flow distribution, where a greater percentage of the liquid entered the drainage lumen through openings other than the nearest opening. In this way, fluid may be more efficiently collected through the plurality of openings, thereby reducing fluid blockage and improving the distribution of negative pressure over the renal pelvis and/or kidney.

TABLE 4

Example 3

Example 2 also shows the flow distribution of openings of equal diameter. However, as shown in table 5, the opening pitch was smaller (10mm compared to 22 mm). As shown in Table 5 and FIG. 35B, 80.9% of the fluid flowing through the drainage lumen was through the most proximal opening (Q)₆) Into the drainage lumen. 96.3% of the liquid in the drainage lumen passes through the two closest openings (Q)₅And Q₆) Into the drainage lumen.

TABLE 5

System for introducing a negative pressure

Referring to fig. 27, an exemplary system 1100 for introducing negative pressure in a patient's urinary tract to increase renal perfusion is shown. The system 1100 includes one or two ureteral catheters 1212 connected to the fluid pump 2000 to introduce negative pressure. More specifically, the patient's urinary tract includes the patient's right kidney 2 and left kidney 4. The kidneys 2, 4 are responsible for filtering blood and removing waste compounds from the body via urine. Urine produced by the right 2 and left 4 kidneys is discharged into the bladder 10 of the patient through small tubes (i.e., the right 6 and left 8 ureters) that are connected to the kidneys at the

renal pelvis

20, 21. Urine can flow through the

ureters

6, 8 by gravity and peristaltic movement of the ureter wall. The

ureters

6, 8 enter the bladder 10 through ureter orifices or openings 16. The bladder 10 is a flexible and substantially hollow structure adapted to collect urine until the urine is discharged from the body. The bladder 10 can transition from an empty position (as indicated by reference line E) to a full position (as indicated by reference line F). Generally, when the bladder 10 reaches a substantially full condition, urine can drain from the bladder 10 into the urethra 12 through a urethral sphincter muscle or opening 18 located in the lower portion of the bladder 10. The bladder 10 can respond to stress and pressure exerted on the trigone 14 of the bladder 10 by contracting, which refers to the trigone extending between the ureteral opening 16 and the urethral opening 18. The trigone 14 is sensitive to stress and pressure such that when the bladder 10 begins to fill, the pressure on the trigone 14 increases. When the threshold pressure of the trigone 14 is exceeded, the bladder 10 begins to contract to expel the collected urine through the urethra 12.

As shown in fig. 27, 28, the distal portion of the ureteral catheter is deployed in the

renal pelvis

20, 21 proximate to the kidneys 2, 4. The proximal portion of the one or more conduits 1212 is connected to the single outflow port 2002 of the fluid pump 2000 by a Y-fitting 2010 and a tubing set 2050. An exemplary Y-fitting 2010 and tube set 2020 connected thereto are shown in fig. 36, 37. The Y-fitting 2010 includes a tube 2012 made of hard plastic, the tube 2012 including two

inlet ports

2014, 2016 and a single outlet port including a one-way check valve 2018 for preventing backflow. The

inflow ports

2014, 2016 may include a fitting 2020, such as a luer lock fitting, a threaded fitting, or similar mechanism known in the art for receiving the proximal end of the catheter 1212. As shown in fig. 37, the proximal end of the catheter 1212 has corresponding structure for mounting to the Y-connector 2010. The tubing set 2050 includes a length of flexible medical tubing 2052 that extends between the one-way check valve 2018 of the Y-fitting 2010 and a funnel fitting 2054 configured to engage the outflow port 2002 of the fluid pump 2000. The shape and size of the drogue 2054 may be selected based on the type of pump 2000 used. In some embodiments, the drogue 2054 may be formed with a unique configuration such that it can only be connected to a particular type of pump that can safely introduce negative pressure in a patient's bladder, ureter, or kidney. In other embodiments, the fitting 2054 may assume a more general configuration, as described herein, to make it suitable for attachment to a variety of different types of fluid pumps.

System 1100 is just one example of a negative pressure system for introducing negative pressure that may be used with ureteral catheter 1212 disclosed herein. For example, other systems and urine collection assemblies that may be used with catheter 1212 are shown in fig. 1, 9A, 10A, 11A, 19. Further, the conduit 1212 may be connected to a separate negative pressure source. In other embodiments, one or more of the conduits 1212 may be connected to a source of negative pressure, while other conduits 1212 may be connected to an unpressurized liquid collection container.

Additional exemplary ureteral catheter

Fig. 1 shows a urine collection assembly 100, the urine collection assembly 100 including

ureteral catheters

112, 114 located within a patient's urinary tract. For example, the distal ends 120, 121 of the

ureteral catheters

112, 114 may be located in the patient's ureters 2, 4, particularly in the region of the

renal pelvis

20, 21 of the

kidneys

6, 8.

In some embodiments, the urine collection assembly 100 can include two separate ureteral catheters, such as a first catheter 112 disposed in or near the renal pelvis 20 of the right kidney 2 and a second catheter 114 disposed in or near the renal pelvis 21 of the left kidney 4. The

conduits

112, 114 may be separated throughout their length or may be held in close proximity to one another by a clip, ring, clamp, or like attachment mechanism (e.g., joint 150) to facilitate placement or removal of the

conduits

112, 114. In some embodiments, the

catheters

112, 114 may be merged or connected together to form a single drainage lumen. In other embodiments, the

catheters

112, 114 may be inserted or enclosed within another catheter, tube, or sheath disposed along some portion or section thereof to facilitate insertion and removal of the

catheters

112, 114 into and out of the human body. For example, the bladder catheter 116 may be inserted through and/or along the same guidewire as the

ureteral catheter

112, 114 such that the

ureteral catheter

112, 114 extends from the distal end of the bladder catheter 116.

As shown in fig. 1, 2A, 2B, an exemplary ureteral catheter 112 may include at least one elongate body or tube 122 that defines or includes one or more drainage channels or lumens therein, such as a drainage lumen 124. The tube 122 may be sized from about 1Fr to about 9Fr (french catheter scale). In some embodiments, the tube 122 may have an outer diameter of about 0.33mm to about 3mm and an inner diameter of about 0.165mm to about 2.39 mm. In one embodiment, the tube 122 is 6Fr and has an outer diameter of (2.0 + -0.1) mm. The length of the tube 122 may be from about 30cm to about 120cm depending on the age (e.g., child or adult) and gender of the patient.

The tube 122 may be made of a flexible and/or deformable material to facilitate advancement and/or positioning of the tube 122 in the bladder 10 and ureters 6, 8 (as shown in fig. 1). The catheter material should be flexible enough to avoid or reduce irritation of the renal pelvis and ureter, but should also be stiff enough so that the tube 122 does not collapse when pressure is applied to the exterior of the tube 122 by the renal pelvis or other portion of the urethra, or when the renal pelvis and/or ureter are drawn against the tube 122 during negative pressure. For example, the tube 122 may be made of a biocompatible polymer, polyvinyl chloride, polytetrafluoroethylene (PTFE, e.g., PTFE)

) Silicon coated latex or silicon. In one embodiment, the tube 122 is made of thermoplastic polyurethane. At least a portion or all of catheter 112 (e.g., tube 122) may be coated with a hydrophilic coating to facilitate insertion and/or removal and/or enhance comfort. In some embodiments, the coating is a hydrophobic and/or lubricious coating. For example, suitable coatings may include those available from koninklijkedsmn

Hydrophilic coatings or hydrophilic coatings comprising polyelectrolytes, such as the coating disclosed in U.S. patent 8,512,795, which is incorporated herein by reference.

In some embodiments, the tube 122 may include: distal portion 118 (e.g., the portion of tube 122 located in

ureters

6, 8 and renal pelvis 20, 21); a middle portion 126 (e.g., the portion of the tube 122 that extends from the distal portion through the ureteral opening 16 into the bladder 10 and urethra 12 of the patient); and a proximal portion 128 (e.g., the portion of the tube 122 that extends from the urethra 12 to an external fluid collection reservoir and/or pump assembly). In a preferred embodiment, the combined length of the proximal portion 128 and the intermediate portion 126 of the tube 122 is about (54 ± 2) cm. In some embodiments, the tube 122 terminates in another indwelling catheter and/or drainage lumen, such as in the drainage lumen of the bladder catheter 116. In this case, fluid is drained from the proximal end of the

ureteral catheter

112, 114 and is directed out of the body through additional indwelling catheters and/or drainage lumens.

Additional exemplary ureteral positioning sections:

with continued reference to fig. 1, 2A, 2B, the distal portion 118 of the ureteral catheter 112 includes a positioning portion 130 to secure the distal end 120 of the catheter 112 at a desired fluid collection location near or within the

renal pelvis

20, 21 of the kidney 2, 4. In some embodiments, the positioning portion 130 is configured to be flexible and bendable to allow positioning of the positioning portion 130 in the ureter and/or renal pelvis. It is desirable that the locating portion 130 be sufficiently flexible to absorb forces exerted on the catheter 112 and prevent such forces from being transmitted to the ureter. For example, if positioning portion 130 is pulled in a proximal direction P (as shown in fig. 3A) toward the bladder of a patient, positioning portion 130 can be sufficiently flexible to begin straightening and thus can be pulled through the ureter. Similarly, when positioning portion 130 can be reinserted into the renal pelvis or other suitable area within the ureter, it may be biased to return to its deployed configuration.

In some embodiments, positioning portion 1230 is integral with tube 122. In this case, catheter body 122 may be provided with an elbow or coil to form locator 130, and the size and shape of the elbow or coil is selected to secure the catheter in the desired liquid collection position. Suitable bends or coils may include pigtail coils, convolute coils, and/or helical coils. For example, the positioning portion 130 can include one or more radially and longitudinally extending helical coils configured to contact the catheter 112 and passively secure the catheter 112 within the

ureters

6, 8 and near or within the

renal pelvis

20, 21. In other embodiments, the positioning portion 130 is formed by a radially flared or tapered portion of the catheter body 122. For example, as shown in fig. 4A, 4B, the positioning portion 130 can also include a liquid collection portion, such as a tapered or funnel-shaped inner surface 186. In other embodiments, the positioning portion 130 may comprise a separate element connected to the catheter body or tube 122 and extending from the catheter body or tube 122.

The positioning portion 130 may also include one or more perforated sections, such as drainage openings or ports 132 (shown in fig. 3A-3E). The drainage port may be located, for example, at the open

distal end

120, 121 of the tube 122. In other embodiments, the perforated section and/or the drainage port 132 is disposed along a sidewall of the distal portion 118 of the urinary catheter 122. A drainage port or hole may be used to assist in the collection of liquid. In other embodiments, positioning portion 130 is merely a positioning structure, and liquid collection and/or introduction of negative pressure is achieved by structures at other locations on catheter 122.

As shown in fig. 2A, 2B, 3A-3E, exemplary positioners 130 include a plurality of helical coils, such as one or more full coils 184 and one or more half coils or partial coils 183. The positioning portion 130 is transitionable with the plurality of helical coils between the retracted position and the extended position. For example, a substantially straight guidewire may be passed through positioning portion 130 to maintain positioning portion 130 in a substantially straight collapsed position. When the guidewire is removed, the positioning portion 130 can be transitioned to its coiled configuration. In some embodiments, the

coiled tubes

183, 184 extend radially and longitudinally from the distal portion 118 of the tube 122. As shown particularly in fig. 2A and 2B, in a preferred exemplary embodiment, the positioning portion 130 includes two full coils 184 and one half coil 183. The outer diameter of the full coil 184, shown by line D1, may be about (18 ± 2) mm. The diameter D2 of half coil 183 may be about 14 mm. The height H of the coiled position fixing part 130 is about (16 ± 2) mm. The positioning portion 130 can also include one or more drainage holes 132 (shown in fig. 3A-3E), the drainage holes 132 configured to draw liquid into the interior of the urinary catheter 122. In some embodiments, the positioning portion 130 may include six drainage holes and additional holes located on the distal tip 120 of the positioning portion. Each drain hole 132 (shown in fig. 3A-3E) may have a diameter of about 0.7mm to 0.9mm, and preferably about (0.83 ± 0.01) mm. The distance between adjacent drainage holes 132, particularly the linear distance between the drainage holes 132 when the coil is straightened, may be about (22.5 ± 2.5) mm.

As shown in figures 3A-3E, in another exemplary embodiment, the distal portion 118 of the drainage lumen proximal to the site 130 defines a straight or curved central axis L. in some embodiments, at least a first coil or half-coil 183 and a second coil or full-coil 184 of the site 130 extend about the axis A of the site 130. at the point where the first coil 183 begins or begins, the tube 122 is bent to an angle α of about 15 degrees to about 75 degrees, preferably about 45 degrees, from the central axis L. in other embodiments, as shown in figures 3A, 3B, the axis A may be co-extensive with the longitudinal central axis L prior to insertion into the body. in other embodiments, as shown in figures 3C-3E, the axis A extends and curves or is at an angle, such as angle β, relative to the central longitudinal axis L prior to insertion into the body.

In some embodiments, the plurality of coils 184 may have equal inner and/or outer diameters D and heights H2. In this case, the coil 184 may have an outer diameter D1 of 10mm to 30 mm. The height H2 between the coils 184 may be about 3mm to 10 mm.

In other embodiments, the positioning portion 130 is inserted in the tapered portion of the renal pelvis. For example, the outer diameter D1 of the coiled tube 184 may increase toward the distal end 120 of the tube 122, forming a helix having a tapered or partially tapered configuration. For example, the distal or maximum outer diameter D1 of the conical helix is about 10mm to about 30mm, which corresponds to the size of the renal pelvis. The height H2 of positioning portion 130 is about 10mm to about 30 mm.

In some embodiments, the outer diameter D1 and/or the height H2 of the coiled tubing 184 can vary regularly or irregularly. For example, the outer diameter D1 of the coils or the height H2 between coils may be increased or decreased by an amount (e.g., by about 10% to about 25% between adjacent coils 184). For example, for a positioner 130 having three coils (e.g., as shown in fig. 3A, 3B), the outer diameter D3 of the nearest coil or first coil 183 may be about 6mm to 18mm, the outer diameter D2 of the middle coil or second coil 185 may be about 8mm to about 24mm, and the outer diameter D1 of the farthest coil or third coil 187 may be about 10mm to about 30 mm.

The positioning portion 130 can also include a drainage port 132 or hole disposed on or through the side wall of the catheter 122 at or near the positioning portion 130 to allow urine waste to flow from the exterior of the catheter 122 to the interior of the catheter 122. The location and size of the drainage port 132 may vary depending on the desired flow rate and the morphology of the positioning portion. Liquid discharge port132 may be about 0.005mm to about 1.0mm in diameter. The spacing of the drainage ports 132 may be about 1.5mm to about 25 mm. The drainage ports 132 may be spaced in any arrangement (e.g., linear or offset). In some embodiments, the drainage port 132 may be non-circular and may have a surface area of about 0.002mm²To 0.79mm²。

In some embodiments, as shown in fig. 3A, the drainage port 132 is disposed on the entire perimeter of the side wall of the urinary catheter 122 to increase the amount of liquid aspirated into the drainage lumen 124 (as shown in fig. 1, 2A, 2B). In other embodiments, as shown in fig. 3B-3E, the drainage ports 132 may be disposed only or substantially only on the radially inward sides of the coil 184 to prevent the drainage ports 132 from becoming blocked or clogged, and the outward sides of the coil may be free or substantially free of the drainage ports 132. For example, when negative pressure is introduced in the ureter and/or renal pelvis, mucosal tissues of the ureter and/or kidney may be drawn against the positioning portion 130 and may block some of the drainage ports 132 located on the outer periphery of the positioning portion 130. When these tissues contact the outer periphery of the positioning portion 130, the drainage ports 132 on the radially inward side of the positioning structure will not be significantly blocked. In addition, the risk of damage to the tissue due to squeezing or contact with the drainage port 132 may be reduced or mitigated.

Referring to fig. 3C, 3D, other embodiments of the ureteral catheter 112 are shown with a positioning portion 130, and the positioning portion 130 comprises a plurality of coils. As shown in fig. 3C, locator 130 includes three coils 184 extending about axis a. Axis a is an arc extending from the central longitudinal axis L of the portion of drainage lumen 181 adjacent to positioning portion 130. The curvature of the positioning portion 130 can be selected to correspond to the curvature of the renal pelvis with a tapered lumen.

As shown in FIG. 3D, in another exemplary embodiment, the positioning section 130 can include two coiled tubes 184 extending about an oblique axis A extending at an angle from the central longitudinal axis L and at an angle to an axis generally perpendicular to the drain tube chamber central axis L, as shown at angle β, angle β can be about 15 degrees to about 75 degrees (e.g., about 105 degrees to about 165 degrees relative to the central longitudinal axis L of the drain tube chamber portion of the catheter 112).

FIG. 3E shows another embodiment of ureteral catheter 112. the positioning section includes three helical coils 184 extending about axis A. axis A is at an angle to the horizontal, as shown by angle β. As described in previous embodiments, angle β may be about 15 degrees to about 75 degrees (e.g., about 105 degrees to about 165 degrees relative to the central longitudinal axis L of the drain lumen portion of catheter 112).

In another embodiment, as shown in fig. 4A, 4B, the positioning portion 130 of the ureteral catheter 112 comprises a urinary catheter 122, the urinary catheter 122 having a widened and/or tapered distal portion, which in some embodiments is located in the renal pelvis and/or kidney of the patient. For example, the positioning portion 130 can have a funnel-shaped structure that includes an outer surface 185 and an inner surface 186, the outer surface 185 abutting against the wall of the ureter and/or kidney, the inner surface 186 configured to direct fluid to the drainage lumen 124 of the catheter 112. The positioner 130 can include a distal end 190 having a second diameter D2 and a proximal end 188 adjacent the distal end of the drainage lumen 124 and having a first diameter D1, and the second diameter D2 is greater than the first diameter D1 when the positioner 130 is in the deployed position. In some embodiments, the positioning portion 130 can transition from a folded or compressed position to an expanded position. For example, the detent 130 may be offset radially outward such that the detent 130 (e.g., funnel) expands radially outward to the deployed state when the detent 130 travels to its liquid collection position.

The positioning portion 130 of the ureteral catheter 112 may be made of various suitable materials that can be transformed from a collapsed state to an expanded state. In one embodiment, positioning portion 130 comprises a tine member or elongate member frame made of a temperature sensitive shape memory material (e.g., nitinol). In some embodiments, the nitinol frame may be covered with a suitable water resistant material, such as silicon, to form a cone or funnel. In this case, liquid is allowed to flow down the inner surface 186 of the positioning portion 130 and into the drainage lumen 124. In other embodiments, as shown in fig. 4A, 4B, the detent 130 is made from various rigid or partially rigid sheets or materials that are bent or molded into a funnel-shaped detent.

In some embodiments, the positioning portion of the ureteral catheter 112 may include one or more mechanical stimulation devices 191 to stimulate nerve and muscle fibers in the adjacent tissues of the ureter and the renal pelvis. For example, the mechanical stimulation device 191 can include linear or annular actuators embedded or mounted near portions of the side walls of the urinary catheter 122 and configured to emit low levels of vibration. In some embodiments, mechanical stimulation may be provided to portions of the ureter and/or renal pelvis to supplement or improve negative pressure efficacy. While not wishing to be bound by theory, it is believed that such stimulation can affect adjacent tissue by, for example, stimulating nerves and/or actuating peristaltic muscles associated with the ureter and/or renal pelvis. Stimulating nerves and actuating muscles may cause pressure gradients or changes in pressure levels in surrounding tissues and organs, which may contribute to or, in some cases, enhance negative pressure therapy.

As shown in fig. 5A, 5B, according to another embodiment, the positioning portion 330 of the ureteral catheter 312 comprises a urinary catheter 322, the urinary catheter 322 having a distal portion 318 formed in a helical structure 332 and an inflatable member or balloon 350 located near the helical structure 332 to provide an additional degree of positioning in the renal pelvis and/or the fluid collection site. The balloon 350 may be inflated to an extent sufficient to anchor it in the renal pelvis or ureter without expanding or damaging the structures. Suitable inflation pressures are known to those skilled in the art and can be readily determined by trial and error. As with the previous embodiment, the helical structure 332 may be obtained by bending the urinary catheter 322 to form one or more coils 334. The coil 334 may have a constant or variable diameter and height as described above. The urinary catheter 322 also includes a plurality of drainage ports 336 disposed on a side wall of the urinary catheter 322 (e.g., on the inward and/or outward side of the coil 334) to allow urine to be drawn into the drainage lumen 324 of the urinary catheter 322, to flow through the drainage lumen 324, and out of the body.

As shown in FIG. 5B, the inflation member or bladder 350 may comprise an annular bladder-like structure, for example, generally heart-shaped in cross-section and defining a cavity 353 by a surface or covering 352 thereof. The lumen 353 is in fluid communication with the inflation lumen 354, and the inflation lumen 354 extends parallel to the drainage lumen 324 defined by the urinary catheter 322. The balloon 350 can be inserted into the conical portion of the renal pelvis and inflated such that its outer surface 356 contacts and bears against the inner surface of the ureter and/or renal pelvis. The inflatable member or balloon 350 can include a tapered inner surface 358 extending longitudinally and radially inward toward the urinary catheter 322. The inner surface 358 can be configured to direct urine toward the urinary catheter 322 to draw urine into the drainage lumen 324. The inner surface 358 may also prevent fluid from accumulating in the ureter, for example around the inflatable member or balloon 350. Desirably, the inflatable positioning portion or balloon 350 is sized to fit within the renal pelvis and may be about 10mm to about 30mm in diameter.

As shown in fig. 6, 7, in some embodiments, an assembly 400 is shown that includes a ureteral catheter 412, and the ureteral catheter 412 includes a locator 410. The positioning portion 410 is made of a porous and/or spongy material and is attached to the distal end 421 of the urinary catheter 422. The porous material can be configured to direct and/or absorb urine and direct the urine to a drainage lumen 424 of the urinary catheter 422. As shown in fig. 7, the positioning part 410 may have a porous wedge structure, which is inserted and fixed in the renal pelvis of the patient. The porous material has a plurality of openings and/or channels. Liquid may be drawn through the channels and openings, for example, due to gravity or negative pressure introduced in the conduit 412. For example, liquid can enter wedge positioner 410 through openings and/or channels and be directed toward distal opening 420 of drainage lumen 424 by, for example, capillary action, peristalsis, or as a result of negative pressure introduced into the openings and/or channels. In other embodiments, as shown in fig. 7, the positioning portion 410 includes a hollow funnel-shaped structure made of a porous sponge-like material. As indicated by arrow a, the liquid travels down the inner surface 426 of the funnel-shaped structure into the drainage lumen 424 defined by the urinary catheter 422. In addition, liquid may enter the funnel-shaped structure of the positioning portion 410 through openings and channels in the porous sponge-like material of the side wall 428. For example, suitable cellular materials may include open-cell polyurethane foams such as polyurethane ethers. Suitable porous materials may also include laminates of woven or non-woven layers, for example comprising polyurethane, silicone, polyvinyl alcohol, cotton or polyester, with or without antimicrobial additives such as silver, and with or without additives for modifying the properties of the material, such as hydrogels, hydrocolloids, acrylics or silicones.

As shown in fig. 8, according to another embodiment, the positioning portion 500 of the ureteral catheter 512 includes an expansion cage 530. Expansion cage 530 includes one or more longitudinally and radially extending hollow tubes 522. For example, the tube 522 may be made of a resilient shape memory material such as nitinol. Cage 530 is configured to transition from a collapsed state for insertion into a patient's urinary tract to an expanded state for positioning in a patient's ureter and/or kidney. The hollow tube 522 includes a plurality of drainage ports 534, which drainage ports 534 may be positioned on the tube, for example on a radially inward side thereof. The drainage ports 534 are configured to allow liquid to flow through or be drawn into the respective tubes 522. The liquid is discharged through the hollow tube 522 into a drainage lumen 524 defined by a catheter body 526 of the ureteral catheter 512. For example, the liquid may flow along the path indicated by arrow 532 in fig. 8. In some embodiments, when negative pressure is introduced in the renal pelvis, kidney and/or ureter, the ureter wall and/or some portion of the renal pelvis may be attracted to the outwardly facing surface of the hollow tube 522. The drainage port 534 is disposed in a position such that when negative pressure is introduced in the ureter and/or kidney, the drainage port 534 is not significantly occluded by ureteral structures.

Exemplary urine collection assemblies:

in some embodiments, as shown in fig. 1, 9A, 11A, the urine collection assembly 100 can further include a bladder catheter 116. The distal ends 120, 121 of the

ureteral catheters

112, 114 may be connected to the bladder catheter 116 to obtain a single urinary drainage lumen, or the ureteral catheter may drain via a tube separate from the bladder catheter 116.

Exemplary bladder catheter

The bladder catheter 116 includes a deployable seal and/or anchor 136 for anchoring, retaining, and/or passively securing the retention portion of the urine collection assembly 100, and in some embodiments for preventing premature and/or infrequent removal of the assembled components during use. The anchoring elements 136 are positioned adjacent the lower wall of the patient's bladder 10 (as shown in fig. 1) to prevent patient movement and/or forces exerted on the

indwelling catheter

112, 114, 116 from being transmitted to the ureter. The interior of the bladder catheter 116 defines a drainage lumen 140, the drainage lumen 140 being configured to transport urine from the bladder 10 to an external urine collection container 712 (as shown in fig. 19). In some embodiments, the bladder catheter 116 may be sized from about 8Fr to about 24 Fr. In some embodiments, the outer diameter of the bladder catheter 116 can be about 2.7mm to about 8 mm. In some embodiments, the inner diameter of the bladder catheter 116 may be about 2.16mm to about 6.2 mm. The bladder catheter 116 may have different lengths to accommodate anatomical differences in the gender and/or size of the patient. For example, a female may have an average urethral length of only a few inches, and thus the length of tube 138 may be relatively short. The average urethra length in men is longer due to the penis and may vary. A bladder catheter 116 with a longer tube 138 may be used for women if the extra tube does not make it more difficult to manipulate the sterile portion of the catheter 116 and/or prevent contamination of the sterile portion of the catheter 116. In some embodiments, the sterile and indwelling portions of the bladder catheter 116 may be about 1 to 3in (for females) to about 20in (for males). The total length of the bladder catheter 116, including the sterile and non-sterile sections, may be from one foot to several feet.

The urinary catheter 138 can have one or more drainage ports 142, the drainage ports 142 being located in the bladder 10 to draw urine into the drainage lumen 140. For example, excess urine remaining in the bladder 10 of the patient during placement of the

ureteral catheter

112, 114 may be drained from the bladder 10 through the port 142 and the drainage lumen 140. In addition, any urine not collected by the

ureteral catheters

112, 114 accumulates in the bladder 10 and may exit the urinary tract via the drainage lumen 140. The drainage lumen 140 can be placed under negative pressure to assist in collecting the liquid, or can be maintained at atmospheric pressure to collect the liquid by gravity and/or due to partial contractions of the bladder 10. In some embodiments, the

ureteral catheters

112, 114 may extend from the drainage lumen 140 of the bladder catheter 116 to facilitate and/or simplify insertion and placement of the

ureteral catheters

112, 114.

As shown particularly in FIG. 1, the deployable seal and/or anchor 136 is disposed at or near the distal end 148 of the bladder catheter 116. The deployable anchor 136 is configured to transition between a deployed state and a collapsed state for insertion into the bladder 10 via the urethra 12 and the urethra opening 18. The anchoring element 136 is configured to be deployed and positioned about the lower portion of the bladder 10 and/or proximate the urethral opening 18. For example, the anchoring element 136 can be positioned near the urethral opening 18 to enhance negative pressure aspiration of the bladder 10 or to partially, substantially or completely seal the bladder 10 in the absence of negative pressure to ensure that urine in the bladder 10 is directed through the drainage lumen 140 and prevented from leaking into the urethra 12. For a bladder catheter 116 having an elongate tube 138 sized 8Fr to 24Fr, the anchoring element 136 may be sized in the deployed state from about 12Fr to 32Fr (e.g., about 4mm to about 10.7mm in diameter), and preferably from about 24Fr to 30 Fr. The diameter of the 24Fr anchor is about 8 mm. It is contemplated that the size of the 24Fr anchor 136 will be a single size suitable for all or most patients. For a catheter 116 having a 24Fr anchor 136, a suitable length for the anchor 136 is about 1.0cm to 2.3cm, and preferably about 1.9cm (about 0.75 in).

Exemplary bladder Anchor configurations

Referring specifically to fig. 1, 12A, 13, an exemplary bladder anchor 136 in the form of an expanding balloon 144 is shown. The dilation (e.g., inflation) balloon 144 may be, for example, a spherical balloon of a Foley catheter. The diameter of the balloon 144 may be about 1.0cm to 2.3cm, and is preferably about 1.9cm (0.75 in). Balloon 144 is preferably made of a flexible material, including, for example, a biocompatible polymer, polyvinyl chloride, polytetrafluoroethylene (PTFE, e.g., PTFE)

) Silicon coated latex or silicon.

The balloon 144 is in fluid communication with the inflation lumen 146 and is expandable as a result of the introduction of a liquid into the balloon 144. In the deployed state, the balloon 144 may be a generally spherical structure mounted on and extending radially outward from the urinary catheter 138 of the bladder catheter 116 and having a central lumen or channel for passage of the urinary catheter 138. In some embodiments, the urinary catheter 138 extends through the lumen defined by the balloon 144 such that an open distal end 148 of the urinary catheter 138 extends distally beyond the balloon 144 and toward the center of the bladder 10 (as shown in fig. 1). Excess urine collected in the bladder 10 can be drawn into the drainage lumen 140 through the open distal end 148 thereof.

In one embodiment, as shown in fig. 1, 12A, the

ureteral catheters

112, 114 extend from the open distal end 148 of the drainage lumen 140. In another embodiment, as shown in fig. 14, the

ureteral catheters

112, 114 extend through a port 172 or opening, the port 172 or opening being disposed on a sidewall of the urinary catheter 138 distal to the balloon 144. The port 172 may be circular or oval in shape. The port 172 is sized to receive the

ureteral catheter

112, 114 and thus may be about 0.33mm to about 3mm in diameter. In another embodiment, as shown in fig. 13, the bladder catheter 116 is positioned alongside the balloon 144 rather than extending through the central lumen defined by the balloon 144. As in other embodiments, the

ureteral catheters

112, 114 extend through a port 172 in the sidewall of the bladder catheter 116 and into the bladder 10.

Referring to fig. 12B, a cross-sectional view of the bladder catheter 116 and

ureteral catheters

112, 114 is shown. In one embodiment, as shown in fig. 12B, the bladder catheter 116 comprises a double lumen catheter having a drainage lumen 140 in a central region and a smaller inflation lumen 146 extending along the periphery of the urinary catheter 138. The

ureteral catheters

112, 114 are inserted or enclosed in a central drainage lumen 140. The

ureteral catheters

112, 114 are single lumen catheters having a sufficiently narrow cross-section so as to be receivable within the drainage lumen 140. In some embodiments, as described above, the

ureteral catheters

112, 114 extend through the entire bladder catheter 116. In other embodiments, the

ureteral catheters

112, 114 terminate in the drainage lumen 140 of the bladder catheter 116, and are located in the patient's ureter 12 or outside of the drainage lumen 140. In another embodiment, as shown in fig. 12C, the bladder catheter 116a is a multi-lumen catheter defining at least four lumens, namely a first lumen 112A for conducting liquid from the first ureteral catheter 112 (shown in fig. 1), a second lumen 114a for conducting liquid from the second ureteral catheter 114 (shown in fig. 1), a third lumen 140a for draining urine from the bladder 10 (shown in fig. 1), and an inflation lumen 146a for introducing liquid into and out of the balloon 144 (shown in fig. 12A) to inflate and deflate the balloon 144.

Referring to FIG. 15, another embodiment of a catheter balloon 144 for use with the urine collection assembly 100 is shown. As shown in FIG. 15, the balloon 144 is positioned partially within the patient's bladder 10 and partially within the urethra 12 to enhance the bladder sealing effect. The central portion 145 of the balloon 144 is radially constricted by the urethral opening 18, thereby defining a spherical upper volume in the lower portion of the bladder 10 and a spherical lower volume in the distal portion of the urethra 12. As in the previous embodiment, the bladder catheter 116 extends through a central lumen defined by the balloon 144 and toward a central portion of the bladder 10 and has a drainage port 142 for directing the flow of urine in the bladder 10 through the drainage lumen 140 of the catheter 116. The drainage port 142 may be generally circular or oval in shape and may be about 0.005mm to about 8mm in diameter.

Referring again to fig. 9A, 9B, another embodiment of a urine collection assembly 100 having a bladder anchoring device 134 is shown. The bladder anchoring device 134 includes a bladder catheter 116 defining a drainage lumen 140, an inflation lumen 146, and an anchoring element 136 (i.e., another embodiment of a dilation balloon 144, which is located in the lower portion of the bladder 10). Unlike the previous embodiments, the port 142 for receiving the

ureteral catheter

112, 114 is located near and/or below the balloon 144. The

ureteral catheters

112, 114 extend from the port 142 and, as in the previous embodiments, extend through the ureteral orifice or opening of the bladder and into the ureter. When the anchor 136 is deployed in the bladder, the port 142 is located at the lower portion of the bladder and near the urethral opening. The

ureteral catheters

112, 114 extend from the port 172 between the lower portion of the balloon 144 and the bladder wall. In some embodiments, the

catheters

112, 114 can be positioned to prevent the balloon 144 and/or bladder wall from occluding the port 142 so that excess urine collected in the bladder can be drawn into the port 142 and expelled from the body.

As shown again in fig. 10A, 10B, in another embodiment of urine collection assembly 200, an expansion cage 210 anchors assembly 200 in the bladder. The expansion cage 210 includes a plurality of flexible members 212 or tines that extend longitudinally and radially outward from the catheter body 238 of the bladder catheter 216, which in some embodiments may be similar to the positioning portion of the ureteral catheter in fig. 8 described above. These members 212 may be made of a suitable elastic and shape memory material (e.g., nitinol). In the deployed position, the member 212 or tines have sufficient curvature to define a central cavity 242 that is spherical or ellipsoidal. The cage 210 is attached to the open distal end 248 of the catheter or catheter body 238 to allow access to the drainage lumen 240 defined by the catheter or catheter body 238. The cage 210 is sized to be positioned within the lower portion of the bladder, and may be defined to be 1.0cm to 2.3cm in diameter and length, and preferably about 1.9cm (0.75 in).

In some embodiments, the cage 210 also includes a shield or cover 214 over the distal portion of the cage 210 to prevent or reduce the likelihood of tissue (i.e., the distal wall of the bladder) becoming caught or pinched by contact with the cage 210 or member 212. More specifically, as the bladder contracts, the inner distal wall of the bladder contacts the distal side of the cage 210. The cover 214 may prevent pinching or sticking of tissue, may reduce patient discomfort, and may protect the device during use. The cover 214 may be at least partially made of a porous and/or permeable biocompatible material (e.g., a woven polymer mesh). In some embodiments, the cover 214 encloses all or substantially all of the cavities 242. In this case, the cover 214 defines an opening adapted to receive the

ureteral catheter

112, 114. In some embodiments, the covering 214 covers only the distal 2/3, the distal half, or the distal third portion, or any amount, of the cage 210. In this case, the

ureteral catheters

112, 114 pass through the uncovered portion of the cage 210.

The cage 210 and cover 214 may be transitioned from a collapsed position in which the members 212 are tightly collapsed together about the central portion and/or about the bladder catheter 116 to allow insertion through a catheter or sheath into a deployed position. For example, where the cage 210 is made of a shape memory material, the cage 210 may be configured to transition to the deployed position when it is heated to a sufficiently high temperature (e.g., a body temperature of 37 ℃). In the deployed position, the diameter D of the cage 210 is preferably wider than the urethral opening to enable the cage 210 to support the

ureteral catheters

112, 114 and prevent patient movement from being conducted through the

ureteral catheters

112, 114 to the ureter. When the assembly 200 is deployed in the urinary tract, the

ureteral catheters

112, 114 extend from the open distal end 248 of the bladder catheter 216, past the longitudinally extending members 212 of the cage 210, and into the bladder. Advantageously, the open (e.g., low profile) arrangement of the members 212 or tines facilitates manipulation of the

ureteral catheters

112, 114 from the bladder catheter 116 and through the bladder. In particular, the open arrangement of the members 212 or tines does not obstruct or clog the distal opening 248 and/or drainage port of the bladder catheter 216, making it easier to manipulate the

catheters

112, 114.

Referring to FIG. 16, a portion of another embodiment of a urine collection assembly 100b is shown. Urine collection assembly 100b includes a first ureteral catheter 112b and a second ureteral catheter 114 b. The assembly 100b does not include a separate bladder drainage catheter as described in the previous embodiments. Instead, one of the ureteral catheters 112b includes a coil 127b formed in a middle portion of the catheter 112b (e.g., the portion of the catheter that is located in the lower portion of the patient's bladder). The spiral portion 127b includes at least one and preferably two or more coils 176 b. The coil 176b can be formed by bending the urinary catheter 138b to achieve the desired coil configuration. The lower coil 178b of the spiral portion 127b is against and/or near the urethral meatus. Desirably, the diameter D of the spiral portion 127b is larger than the urethral opening to prevent the spiral portion 127b from being sucked into the urethra. In some embodiments, a port 142b or opening is provided in a sidewall of the urinary catheter 138b for connecting the first ureteral catheter 112b to the second ureteral catheter 114 b. For example, the second catheter 114b can be inserted into the port 142b to establish fluid communication between the first ureteral catheter 112b and the second ureteral catheter 114 b. In some embodiments, the second catheter 114b terminates just within the drainage lumen 140b of the first catheter 112 b. In other embodiments, the second ureteral catheter 114b passes through and/or extends along the length of the drainage lumen 140b of the first catheter 112b, but is not in fluid communication with the drainage lumen 140 b.

Referring again to fig. 11A, 11B, another exemplary urine collection assembly 100 having a bladder anchoring device 134 is shown. The assembly 100 includes

ureteral catheters

112, 114 and a separate bladder catheter 116. More specifically, as described in previous embodiments, the assembly 100 includes

ureteral catheters

112, 114, each including a distal portion 118 located within or near the right and left kidneys, respectively. The

ureteral catheter

112, 114 includes an

indwelling portion

118, 126, 128 that extends through the ureter, bladder and urethra. The

ureteral catheters

112, 114 also include an external portion 170 that extends from the patient's urethra 12 to the pump assembly to introduce negative pressure in the renal pelvis and/or kidneys. The assembly 100 also includes a bladder anchoring device 134 that includes a bladder catheter 116 and an anchor 136 (e.g., a Foley catheter) deployed in the bladder to prevent or reduce the transmission of patient motion to the

ureteral catheters

112, 114 and/or ureters. A bladder catheter 116 extends from the bladder 10 through the urethra to a fluid collection reservoir to drain by gravity or negative pressure to collect fluid. In some embodiments, the exterior of the tubing extending between collection container 712 and pump 710 (as shown in fig. 19) may include one or more filters to prevent urine and/or particulates from entering the pump. As described in the previous embodiment, the bladder catheter 116 is used to drain excess urine remaining in the patient's bladder during catheter placement.

Exemplary joints and clamps:

referring to fig. 1, 11A, 17A-17C, the assembly 100 further includes a manifold or fitting 150 to connect the two or

more conduits

112, 114, 116 at locations outside of the patient's body. In some embodiments, the fitting 150 may be a clamp, manifold, valve, fastener, or other element of a fluid path set as known in the art to connect the conduit to an external flexible tube. As shown in fig. 17A, 17B, the manifold or fitting 150 includes a two-piece body including an inner portion 151 mounted within a housing 153. The inner portion 151 defines a channel for directing liquid between the

inflow ports

154, 155 and the outflow port 158. The

inflow ports

154, 155 may include threaded inserts 157 for receiving the proximal portions of the

conduits

112, 114. Desirably, the insert 157 is sized to securely receive and secure a flexible tube having a size of 1Fr to 9 Fr. Typically, a user screws insert 157 into

ports

154, 155 in the direction of arrow a1 (as shown in fig. 17B), thereby securing insert 157 to the respective urinary catheter 122.

Once the

tubes

112, 114 are mounted to the fitting 150, urine entering the fitting 150 through the

vacuum inlet ports

154, 155 is directed through the catheter in the direction of arrow A2 (as shown in FIG. 17B) to the vacuum outlet port 158. The vacuum outflow port 158 can be connected to a liquid collection reservoir 712 and/or a pump assembly 710 (shown in fig. 19), for example, by a flexible tube 166 defining a liquid flow path.

With particular reference to fig. 17C, another example fitting 150 may be configured to connect three or

more conduits

112, 114, 116 to

outflow ports

158, 162. The adapter 150 may include a structure or body having a distal side 152, the distal side 152 including two or more

vacuum inflow ports

154, 155 connected to the proximal ends of the

ureteral catheters

112, 114, and a separate gravity drainage port 156 connected to the proximal end of the bladder catheter 116. The

vacuum ports

154, 155 and/or proximal ends of the

ureteral catheters

112, 114 may include particular configurations to ensure that the

ureteral catheters

112, 114 are connected to a vacuum source and not to some other fluid collection assembly. Similarly, the gravity drainage port 156 and/or the proximal end of the bladder catheter 116 may include another connector configuration to ensure that the bladder catheter 116, but not one of the

ureteral catheters

112, 114, is capable of draining by gravity drainage. In other embodiments, the

ports

154, 155, 156 and/or the proximal ends of the

conduits

112, 114, 116 may include visual indicia to aid in properly positioning the fluid collection system.

In some embodiments, urine received in

vacuum ports

154, 155 may be directed through a Y-catheter to a single vacuum outflow port 158 located on a proximal side 160 of fitting 150. As in the previous embodiments, the vacuum outflow port 158 may be connected to a fluid collection container 712 and/or pump 710 by a suitable flexible tube or other conduit to draw urine from the body and introduce negative pressure in the ureters and/or kidneys. In some embodiments, the outflow port 156 and/or the fitting 150 may be configured to be attached only to a vacuum source or pump operating within a predetermined pressure range or power level to prevent exposure of the

ureteral catheter

112, 114 to elevated negative pressure levels or intensities. The proximal side 160 of the fitting 150 may also include a gravity outflow port 162 in fluid communication with the inflow port 156. Gravity outflow port 162 can be connected directly to urine collection container 712 to collect urine by gravity drainage.

With continued reference to fig. 17C, in some embodiments, for ease of system setup and implementation, the vacuum outflow port 158 and the gravity outflow port 162 are arranged in close proximity such that a single insert 164, bracket, or fitting may be connected to the fitting 150 to establish fluid communication with each

port

158, 162. A single insert or fitting may be connected to a multi-conduit hose or tube (e.g., flexible tube 166) having a first conduit in fluid communication with pump 710 and a second conduit in fluid communication with collection container 712. Thus, a user can easily set up an external fluid collection system by inserting a single insert 164 into the fitting 150 and connecting the corresponding conduit to one of the fluid collection container 712 and the pump 710 (as shown in FIG. 19). In other embodiments, a length of flexible tubing 166 is connected between urine collection container 712 and gravity drain port 162, and another length of flexible tubing is connected between pump 710 and vacuum drain port 158.

Exemplary hydraulic control sensor:

referring again to fig. 1, in some embodiments, the assembly 100 further includes a sensor 174 for monitoring a fluid characteristic of urine collected from the

ureters

6, 8 and/or bladder 10. As described herein in connection with fig. 19, information obtained from the sensors 174 may be transmitted to a central data collection module or processor and, for example, may be used to control the operation of an external device (e.g., pump 710) (as shown in fig. 19). The sensor 174 may be integrally formed with one or more of the

catheters

112, 114, 116 (e.g., embedded in the wall of the catheter body or tube) and in fluid communication with the

drainage lumens

124, 140. In other embodiments, one or more sensors 174 may be located in the fluid collection container 712 (as shown in FIG. 19) or in the internal circuitry of an external device (e.g., pump 710).

Exemplary sensors 174 that may be used with the urine collection assembly 100 may include one or more sensor types. For example, catheter assembly 100 may include conductivity sensors or electrodes that sample the conductivity of urine. Normal conductivity of human urine is about 5-10 mS/m. An urine conductivity outside the expected range may indicate a physiological problem with the patient requiring further treatment or analysis. Catheter assembly 100 may also include a flow meter for measuring the flow rate of urine flowing through the

catheters

112, 114, 116. The flow rate can be used to determine the total volume of fluid removed from the body. The

conduits

112, 114, 116 may also include thermometers for measuring the temperature of urine. Urine temperature may be used in conjunction with a conductivity sensor. Urine temperature may also be used for monitoring purposes, as urine temperature outside of the normal physiological range may indicate certain physiological conditions. In some embodiments, the sensor 174 may be a urine analyte sensor to measure the concentration of creatinine and/or protein in urine. For example, various conductivity sensors and optical spectroscopic sensors can be used to determine the concentration of an analyte in urine. Sensors based on color-changing reagent strips may also be used for this purpose.

Method of insertion of urine collection assembly:

having described the urine collection assembly 100 with a ureteral catheter positioning portion and a bladder anchoring device (e.g., a standard or modified Foley-type catheter), the method of inserting and deploying the assembly will now be discussed in detail.

Referring to fig. 18A, steps for positioning the fluid collection assembly within a patient and (optionally) for introducing negative pressure in the ureters and/or kidneys of the patient are shown. As shown in block 610, the health care provider inserts a flexible or rigid cystoscope into the patient's urethra and into the bladder to visualize the ureter orifice or opening. Once a suitable visualization effect is achieved, a guidewire can be passed through the urethra, bladder, ureteral opening, ureter, and to a desired fluid collection location, such as the renal pelvis of the kidney, as shown in block 612. Once the guidewire is advanced to the desired fluid collection location, the ureteral catheter of the present invention (embodiments of which are discussed in detail above) may be inserted over the guidewire to the fluid collection location, as shown in block 614. In some embodiments, the location of the ureteral catheter may be determined by fluoroscopy, as shown at block 616. Once the location of the distal end of the catheter is determined, the positioning portion of the ureteral catheter may be deployed, as shown in block 618. For example, the guidewire may be removed from the catheter, allowing the distal end and/or the positioning portion to transition to the deployed position. In some embodiments, the deployed distal end of the catheter does not completely occlude the ureter and/or renal pelvis, such that urine can flow out of the catheter and through the ureter into the bladder. Avoiding a complete blockage of the ureter avoids damage due to the application of force to the side walls of the ureter, since moving the catheter applies force to the urinary tract tissue.

After the ureteral catheter is in place and deployed, a second ureteral catheter may be positioned in another ureter and/or kidney using the same guidewire using the same insertion and positioning methods described herein. For example, a cystoscope may be used to visualize another ureteral opening in the bladder, and a guidewire may be advanced through the visualized ureteral opening to a fluid collection location in the other ureter. The catheter may be withdrawn over the guidewire and deployed as described herein. Alternatively, the cystoscope and guidewire may be removed from the body. The cystoscope can be reinserted into the bladder through the first ureteral catheter. The cystoscope is used in the manner described above to visualize the ureteral opening and to assist in advancing a second guidewire to the second ureter and/or kidney to locate the second ureteral catheter. In some embodiments, once the ureteral catheter is in place, the guidewire and cystoscope may be removed. In other embodiments, the cystoscope and/or guidewire may be left within the bladder to assist in placement of the bladder catheter.

Alternatively, a bladder catheter may be used. Once the ureteral catheter is in place, the health care provider may insert the distal end of the bladder catheter in a collapsed or collapsed state into the bladder through the patient's urethra, as shown in block 620. The bladder catheter may be a conventional Foley bladder catheter or the bladder catheter of the present invention as detailed above. Once inserted into the bladder, the anchoring elements associated with and/or connected to the bladder catheter may be expanded to a deployed position, as shown at block 622. For example, when using a dilatation or inflation catheter, fluid may be directed through the inflation lumen of the bladder catheter to dilate a balloon structure located in the patient's bladder. In some embodiments, the bladder catheter is inserted into the bladder through the urethra without the use of a guidewire and/or cystoscope. In other embodiments, the bladder catheter is inserted using the same guidewire used to position the ureteral catheter. Thus, when inserted in this way, the ureteral catheter may be arranged to extend from the distal end of the bladder catheter, and (optionally) the proximal end of the ureteral catheter may be arranged to terminate within the drainage lumen of the bladder catheter.

In some embodiments, urine can be drained from the urethra by gravity. In other embodiments, negative pressure is introduced in the ureteral catheter and/or the bladder catheter to facilitate urination.

Referring to fig. 18B, the step of introducing negative pressure in the ureters and/or kidneys using the urine collection assembly is shown. After the indwelling portion of the bladder and/or ureteral catheter is properly positioned and the anchoring/positioning structure is deployed, the outer proximal end of the catheter is connected to a fluid collection or pump assembly, as shown in block 624. For example, a ureteral catheter may be connected to a pump for introducing negative pressure in the renal pelvis and/or kidneys of the patient. Similarly, the bladder catheter may be connected directly to a urine collection container to drain urine from the bladder by gravity, or to a pump to introduce negative pressure in the bladder.

Once the catheter is connected to the pump assembly, negative pressure can be introduced in the renal pelvis and/or kidney and/or bladder through the drainage lumen of the ureteral catheter and/or bladder catheter, as shown in block 626. Negative pressure can be used to counteract extravasation-mediated interstitial hydrostatic pressure that results from elevated intra-abdominal pressure and, concomitantly, or elevated renal venous or lymphatic pressure. Thus, the introduction of negative pressure can increase the flow of filtrate through the medullary tubules and reduce reabsorption of water and sodium.

In some embodiments, mechanical stimulation may be applied to portions of the ureter and/or renal pelvis to supplement or improve negative pressure efficacy. For example, mechanical stimulation devices disposed in the distal portion of the ureteral catheter, such as linear actuators and other known devices for providing, for example, vibrational waves, may be activated. While not wishing to be bound by theory, it is believed that such stimulation can affect adjacent tissue by, for example, stimulating nerves and/or actuating peristaltic muscles associated with the ureter and/or renal pelvis. Stimulating nerves and actuating muscles may cause pressure gradients or changes in pressure levels in surrounding tissues and organs, which may contribute to or, in some cases, enhance negative pressure therapy. In some embodiments, the mechanical stimulation may comprise pulsatile stimulation. In other embodiments, a low level of mechanical stimulation may be continuously provided when negative pressure is introduced through the ureteral catheter. In other embodiments, the inflated portion of the ureteral catheter may be inflated and deflated in a pulsatile manner to stimulate adjacent nerve and muscle tissue, in a manner similar to the mechanical stimulation devices described herein.

Due to the introduced negative pressure, urine is drawn through the drainage lumen of the catheter into the catheter at its distal end at the plurality of drainage ports and into a fluid collection container for processing, as shown in block 628. As urine is drawn into the collection container, sensors disposed in the liquid collection system may provide a number of measurements of the urine at block 630, which may be used to assess the amount of urine collected and information about the patient's physical condition and its urine composition. In some embodiments, as shown at block 632, information obtained by the sensors is processed by a processor associated with the pump and/or another patient monitoring device and displayed to the user via a visual display of an associated feedback device at block 634.

Exemplary liquid collection systems:

having described an exemplary urine collection assembly and method for positioning such an assembly within a patient, referring to fig. 19, a system 700 for introducing negative pressure in a ureter and/or kidney of a patient will now be described. The system 700 may include a ureteral catheter, bladder catheter, or urine collection assembly 100, as described above. As shown in fig. 19, the

ureteral catheters

112, 114 and/or the bladder catheter 116 of the assembly 100 are connected to one or more fluid collection containers 712 to collect urine withdrawn from the renal pelvis and/or bladder. In some embodiments, the bladder catheter 116 and

ureteral catheter

112, 114 are connected to different fluid collection containers 712. A liquid collection container 712 connected to the

ureteral catheter

112, 114 may be in fluid communication with an external fluid pump 710 to introduce negative pressure in the ureter and kidney through the

ureteral catheter

112, 114. Such negative pressure may be provided to overcome interstitial pressure and form urine in the kidneys or nephrons, as described herein. In some embodiments, the connection between the fluid collection container 712 and the pump 710 may use a fluid lock or fluid barrier to prevent air from entering the renal pelvis or kidneys in the event of an accidental therapeutic or non-therapeutic pressure change. For example, the inflow and outflow ports of the liquid container may be located below the liquid level in the container. Thus, air is prevented from entering the medical tube or catheter through the inflow or outflow port of the liquid container 712. As previously described, the outer portion of the tubing extending between liquid collection container 712 and pump 710 may include one or more filters to prevent urine and/or particulates from entering pump 710.

As shown in fig. 19, the system 700 also includes a controller 714, such as a microprocessor, electrically coupled to the pump 710 and having or associated with computer-readable memory 716. In some embodiments, the memory 716 includes instructions that, when executed, may cause the controller 714 to receive information from sensors 174 located on or associated with portions of the assembly 100. The condition information of the patient may be determined based on information from the sensor 174. Information from the sensor 174 may also be used to determine and implement operating parameters of the pump 710.

In some embodiments, the controller 714 is incorporated into a separate remote electronic device, such as a dedicated electronic device, a computer, a tablet, or a smartphone, that is in communication with the pump 710. Alternatively, a controller 714 may be installed in the pump 710, the controller 714 may control a user interface, for example, to manually operate the pump 710, and may also control system functions such as receiving and processing information from the sensors 174.

The controller 714 is configured to receive information from the one or more sensors 174 and store the information in the associated computer-readable memory 716. For example, the controller 714 may be configured to receive information from the sensor 174 at a predetermined rate (e.g., once per second) and determine the conductivity based on the received information. In some embodiments, the algorithm used to calculate conductivity may also be used with other sensor measurements, such as urine temperature, to obtain a more reliable conductivity measurement.

The controller 714 may also be used to calculate patient body condition statistics or diagnostic indicators to indicate changes in the patient's body condition over time. For example, the system 700 may be used to determine the total sodium output. The total sodium displaced may vary, for example, based on a combination of flow rate and conductivity over a period of time.

With continued reference to fig. 19, the system 700 may also include a feedback device 720, such as a visual display or audio system, for providing information to the user. In some embodiments, the feedback device 720 may be integrated with the pump 710. Alternatively, the feedback device 720 may be a separate dedicated or multi-purpose electronic device, such as a computer, laptop, tablet, smart phone, or other handheld electronic device. The feedback device 720 is configured to receive calculated or determined measurements from the controller 714 and present the received information to the user. For example, the feedback device 720 may be used to display the current negative pressure (in mmHg) introduced into the urinary tract. In other embodiments, the feedback device 720 may be used to display the current flow rate of urine, temperature, current conductivity of urine (in mS/m), total urine produced during the procedure, total sodium excreted during the procedure, other physical parameters, or any combination thereof.

In some embodiments, the feedback device 720 also includes a user interface module or component that allows a user to control the operation of the pump 710. For example, a user may activate or deactivate the pump 710 via a user interface. The user may also adjust the pressure introduced by pump 710 to achieve a greater amount or rate of sodium and liquid removal.

Optionally, the feedback device 720 and/or the pump 710 further comprise a data transmitter 722 to transmit information from the device 720 and/or the pump 710 to other electronic equipment or a computer network. The data transmitter 722 may utilize a short range or long range data communication protocol. An embodiment of the short-range data transmission protocol is

The remote data transmission network comprises, for example, Wi-Fi or cellular networks. The data transmitter 722 may transmit information to the patient's healthcare worker to inform the healthcare worker of the patient's current condition. Alternatively or additionally, information may be transmitted, for example, from the data transmitter 722 to an existing database or information storage location for entering recorded information, for example, into a patient's Electronic Health Record (EHR).

With continued reference to fig. 19, in some embodiments, in addition to urine sensor 174, system 700 includes one or more patient monitoring sensors 724. Patient monitoring sensors 724 may include invasive and non-invasive sensors to measure information about the patient's urine composition (as detailed above), blood composition (e.g., hematocrit, analyte concentration, protein concentration, creatinine concentration), and/or blood flow (e.g., blood pressure, blood flow rate). Hematocrit refers to the ratio of the volume of red blood cells to the total volume of blood. Normal hematocrit is about 25% to 40%, preferably about 35% and 40% (e.g., 35% to 40% red blood cells and 60% to 65% plasma by volume).

Non-invasive patient monitoring sensors 724 may include a pulse oximetry sensor, a blood pressure sensor, a heart rate sensor, and a respiration sensor (e.g., a carbon dioxide sensor). Invasive patient monitoring sensors 724 may include invasive blood pressure sensors, glucose sensors, blood flow rate sensors, hemoglobin sensors, hematocrit sensors, protein sensors, creatinine sensors, and the like. In further embodiments, the sensor may be associated with an extracorporeal blood system or circuit and used to measure a parameter of blood flowing in a conduit of the extracorporeal system. For example, an analyte sensor (e.g., a capacitive sensor or an optical spectroscopic sensor) may be associated with a conduit of an extracorporeal blood system to measure a parameter value of a patient's blood as it flows through the conduit. The patient monitoring sensor 724 may be in wired or wireless communication with the pump 710 and/or the controller 714.

In some embodiments, controller 714 may cause pump 710 to provide therapy to the patient based on information obtained from urine analyte sensor 174 and/or patient monitoring sensor 724 (e.g., blood monitoring sensor). For example, the operating parameters of the pump 710 may be adjusted based on changes in the patient's blood hematocrit, blood protein concentration, creatinine concentration, urine output, urine protein concentration (e.g., albumin), and other parameters. For example, the controller 714 may be configured to receive information regarding the patient's blood hematocrit ratio or creatinine concentration from the patient monitoring sensor 724 and/or the analyte sensor 174. Controller 714 may be configured to adjust operating parameters of pump 710 based on the measurements of blood and/or urine. In other embodiments, the hematocrit ratio may be measured from a blood sample taken periodically from the patient. The test results may be provided to the controller 714 for processing and analysis, either manually or automatically.

As described herein, a patient's hematocrit measurement may be compared to a predetermined threshold or clinically acceptable value for the general population. Typically, women have lower hematocrit levels than men. In other embodiments, the measured hematocrit value may be compared to a patient baseline value obtained prior to surgery. When the measured hematocrit value increases to within an acceptable range, the pump 710 may be turned off, thereby stopping the introduction of negative pressure in the ureter or kidney. Similarly, the negative pressure intensity may be adjusted based on the measured parameter value. For example, as the measured parameters of the patient gradually approach acceptable ranges, the intensity of negative pressure induced in the ureters and kidneys may be reduced. Conversely, if an undesirable trend is identified (e.g., a decrease in hematocrit value, urination rate, and/or creatinine clearance), the negative pressure intensity may be increased to produce a positive physiological result. For example, the pump 710 may be configured to first provide a low level of negative pressure (e.g., about 0.1mmHg to 10 mmHg). The negative pressure may then be gradually increased until a positive trend in the patient's creatinine level is observed. However, the negative pressure provided by the pump 710 typically does not exceed about 50 mmHg.

Referring to fig. 20A, 20B, an exemplary pump 710 for use with the system is shown. In some embodiments, the pump 710 is a micro-pump configured to pump fluid from the conduits 112, 114 (e.g., as shown in fig. 1) and has a sensitivity or accuracy of about 10mmHg or less. Desirably, the pump 710 is capable of providing urine at a flow rate of 0.05mL/min to 3mL/min for an extended period of time (e.g., about 8h to about 24h per day for a period of one (1) day to about 30 days or more). When the flow rate is 0.2mL/min, the system 700 is expected to collect approximately 300mL of urine per day. The pump 710 can be configured to introduce a negative pressure in the bladder of the patient in a range from about 0.1mmHg to 50mmHg, or from about 5mmHg to about 20mmHg (gauge pressure at the pump 710). For example, a micropump manufactured by Langer corporation (model BT100-2J) may be used with the system 700 of the present invention. Diaphragm pumps and other types of commercial pumps may also be used for this purpose. Peristaltic pumps may also be used with the system 700. In other embodiments, negative pressure may be introduced using a piston pump, vacuum bottle, or manual vacuum source. In other embodiments, the system may be connected to a wall suction source (such as may be available in a hospital) via a vacuum regulator to reduce the negative pressure to a therapeutically appropriate level.

In some embodiments, at least a portion of the pump assembly can be located within a urinary tract of a patient, such as the bladder. For example, the pump assembly may include a pump module and a control module coupled to the pump module, and the control module is configured to direct movement of the pump module. At least one (one or more) of the pump module, control module, or power source may be located within the patient's urinary tract. The pump module may include at least one pump element located within the liquid flow passage to draw liquid through the passage. Some embodiments of suitable Pump assemblies, systems, and methods of use are disclosed in U.S. patent application 62/550,259, entitled "Indwelling Pump for furniture Removal from the Urenar track," filed concurrently herewith, the disclosure of which is hereby incorporated by reference in its entirety.

In some embodiments, the pump 710 is configured for long-term use, and thus is capable of maintaining precise pumping for long periods of time, such as about 8 hours to about 24 hours per day for 1 day to about 30 days or more. Further, in some embodiments, the pump 710 is configured to be manually operated, and in this case it has a control panel 718 that allows the user to set the desired inhalation value. The pump 710 may also have a controller or processor, which may be the same controller used in operating the system 700, or may be a separate processor dedicated to the operation of the pump 710. In either case, the processor is configured to both receive instructions to manually operate the pump 710 and to automatically operate the pump 710 according to predetermined operating parameters. Alternatively or additionally, the processor may control the operation of the pump 710 based on feedback information received from a plurality of sensors associated with the catheter.

In some embodiments, the processor is configured to cause the pump 710 to operate intermittently. For example, the pump 710 may be configured to emit a negative pressure pulse and not introduce negative pressure during a subsequent time period. In other embodiments, the pump 710 may be configured to alternately introduce negative and positive pressures to produce alternating pumping and pumping actions. For example, a positive pressure of about 0.1 to 20mmHg (preferably about 5 to 20mmHg) may be provided, and then a negative pressure of about 0.1 to 50mmHg may be provided.

Treatment for removing excess fluid from the body of a hemodilution patient

According to another aspect of the present invention, a method of removing excess fluid from the body of a hemodilution patient is provided. In some embodiments, hemodilution may refer to an increase in the volume of plasma relative to red blood cells and/or a decrease in the concentration of red blood cells in the blood circulation (as may occur when a patient obtains an excess of fluid). The method may involve measuring and/or monitoring the hematocrit level of the patient to determine when the blood dilution has been properly completed. Low hematocrit levels are a common post-operative or post-traumatic condition that can lead to poor treatment outcomes. Therefore, blood dilution management and confirmation that hematocrit levels are restored to normal is a desirable treatment outcome for both intra-operative and post-operative patient care.

FIG. 24 illustrates the steps of removing excess fluid from within a patient using the devices and systems described herein. As shown in fig. 24, the therapy includes deploying a urinary catheter (e.g., a ureteral catheter) within a patient's ureter and/or kidney to cause urine to flow out of the ureter and/or kidney, as shown in block 910. Catheters may be placed to avoid blocking the ureters and/or kidneys. In some embodiments, the fluid collection portion of the catheter may be located in the renal pelvis of the patient's kidney. In some embodiments, a ureteral catheter may be placed in each kidney of a patient. In other embodiments, a urine collection catheter may be placed in the bladder or ureter. In some embodiments, the ureteral catheter comprises one or more of any of the positioning portions described herein. For example, a ureteral catheter may include a tube that defines a drainage lumen that includes a helical positioning portion and a plurality of drainage ports. In other embodiments, the catheter may include an inflation positioning portion (e.g., a balloon catheter), a funnel-shaped liquid collection and positioning portion, or a pigtail coil.

As shown in block 912, the method further includes introducing negative pressure in the ureter and/or kidney through the catheter to induce the production of urine in the kidney and remove the urine from the patient. It is desirable to maintain the negative pressure for a time sufficient to clinically significantly reduce the patient's blood creatinine level.

The negative pressure may be maintained for a predetermined period of time. For example, the user may be instructed to operate the pump during surgery or during a period of time selected based on the physiological characteristics of the patient. In other embodiments, the condition of the patient may be monitored to determine when sufficient therapy has been provided. For example, as shown in block 914, the method can further include monitoring the patient to determine when introduction of negative pressure in the patient's ureter and/or kidney can cease. In a preferred non-limiting embodiment, the hematocrit level of the patient is measured. For example, a patient monitoring device may be used to periodically obtain hematocrit values. In other embodiments, blood samples may be drawn periodically to directly measure hematocrit. In some embodiments, the concentration and/or volume of urine excreted from the body through the catheter may also be monitored to determine the rate at which the kidneys produce urine. Similarly, the amount of urine excreted can be monitored to determine the protein concentration and/or creatinine clearance of the patient. A decrease in creatinine and protein concentration in the urine may indicate excessive dilution and/or low kidney function. The measurements may be compared to predetermined thresholds to assess whether the negative pressure therapy is improving the condition of the patient and should be altered or discontinued. For example, as described herein, a desired range of patient hematocrit may be 25% to 40%. In other preferred non-limiting embodiments, the weight of the patient can be measured and compared to dry weight, as described herein. A change in the patient weight measurement indicates that fluid is being removed from the body. Thus, a return to dry body weight indicates that blood dilution has been properly controlled and that the patient's blood has not been over-diluted.

When a positive result is confirmed, the user may cause the pump to cease providing negative pressure therapy, as shown in block 916. Similarly, a patient's blood parameters may be monitored to assess the effectiveness of the negative pressure introduced into the patient's kidney. For example, a capacitive sensor or an analyte sensor may be arranged in fluid communication with a tubing of an extracorporeal blood management system. The sensor may be used to measure information about blood protein, oxygen, creatinine, and/or hematocrit levels. The desired blood parameter value may be measured continuously or periodically and compared to various threshold or clinically acceptable values. Introduction of negative pressure in the patient's kidney or ureter may continue until the measured parameter value is within a clinically acceptable range. As shown at block 916, once the measurement is within a threshold or clinically acceptable range, introduction of negative pressure may be stopped.

Treatment of patients using fluid resuscitation procedures

According to another aspect of the present invention, a method of removing excess fluid from a patient undergoing fluid resuscitation (e.g., coronary artery bypass surgery) by removing excess fluid from within the patient is provided. During fluid resuscitation, a solution such as a saline and/or starch solution is introduced into the patient's blood by a suitable fluid delivery procedure, such as intravenous drip. For example, during some procedures, a patient may be provided with fluid in an amount that is 5 to 10 times the normal daily intake. Fluid replacement or fluid resuscitation may be performed to replenish fluid lost through processes such as sweating, bleeding, dehydration, and the like. Fluid resuscitation may be performed in the context of procedures such as coronary artery bypass surgery to help maintain the fluid balance and blood pressure of the patient at appropriate levels. Acute Kidney Injury (AKI) is a known complication of coronary artery bypass surgery. AKI and hospitalizationProlonged periods are associated with increased morbidity and mortality, even in patients who do not develop renal failure. See Kim et al, Relationship between a periodic inside fluidic administration protocol and an acid kit mj our following off-pump coronary array by type: an on-demand study of the number of the channels,Critical Care19: 350(1995). The introduction of fluid into the blood also reduces hematocrit levels, which has been shown to further increase mortality and morbidity. Studies have also shown that the injection of saline into a patient may reduce renal function and/or inhibit natural fluid management processes. Thus, proper monitoring and control of renal function can improve outcomes, particularly with a reduction in post-operative cases of AKI.

Fig. 25 illustrates a method of treating a patient using a fluid resuscitation procedure. As shown in block 1010, the method includes deploying a ureteral catheter in a patient's ureter and/or kidney such that an occlusion of the ureter and/or kidney does not prevent urine from flowing out of the ureter and/or kidney. For example, the fluid collection portion of the catheter may be located in the renal pelvis. In other embodiments, the catheter may be deployed in the bladder or ureter. The catheter may comprise one or more ureteral catheters as described herein. For example, a ureteral catheter may include a tube that defines a drainage lumen that includes a helical positioning portion and a plurality of drainage ports. In other embodiments, the catheter may include an inflation positioning portion (e.g., a balloon catheter) or a pigtail coil.

As shown in block 1012, optionally, a bladder catheter may also be deployed in the bladder of the patient. For example, a bladder catheter may be positioned to seal the urethral meatus to prevent urine from flowing from the body through the urethra. The bladder catheter may include an inflation anchor (e.g., a Foley catheter) for securing the distal end of the catheter in the bladder. Other arrangements of coils and spirals can also be used to position the bladder catheter appropriately, as described herein. The bladder catheter may be configured to collect urine that enters the bladder of the patient prior to placement of the ureteral catheter. The bladder catheter can also collect urine that flows through the fluid collection portion of the ureteral catheter and into the bladder. In some embodiments, the proximal portion of the ureteral catheter may be located in the drainage lumen of the bladder catheter. Similarly, the bladder catheter can be advanced into the bladder using the same guidewire used to position the ureteral catheter. In some embodiments, negative pressure may be introduced in the bladder through the drainage lumen of the bladder catheter. In other embodiments, negative pressure may be introduced only into the ureteral catheter. In this case, the bladder catheter drains by gravity.

As shown in block 1014, after the ureteral catheter is deployed, negative pressure is introduced in the ureter and/or kidney through the ureteral catheter. For example, negative pressure may be maintained for a sufficient period of time to draw urine, which contains a portion of the fluid provided to the patient during fluid resuscitation. As described herein, the negative pressure may be introduced by an external pump connected to the proximal end or port of the catheter. The pump may be run continuously or periodically depending on the patient's treatment requirements. In some cases, the pump may be caused to alternately introduce negative and positive pressures.

The negative pressure may be maintained for a predetermined period of time. For example, the user may be instructed to operate the pump during surgery or during a period of time selected based on the physiological characteristics of the patient. In other embodiments, the condition of the patient may be monitored to determine when a sufficient amount of fluid has been withdrawn from the patient. For example, as shown in block 1016, the liquid removed from the body can be collected, and the total volume of liquid obtained can be monitored. In this case, the pump may continue to operate until a predetermined amount of fluid has been collected from the ureteral and/or bladder catheter. The predetermined amount of fluid may be based on, for example, the amount of fluid provided to the patient before and during the procedure. As indicated at block 1018, introduction of negative pressure in the ureter and/or kidney is stopped when the total amount of collected fluid exceeds a predetermined amount of fluid.

In other embodiments, the operation of the pump may be determined based on measured physiological parameters of the patient (e.g., measured creatinine clearance, blood creatinine level, or hematocrit ratio). For example, as shown in block 1020, urine collected from a patient may be analyzed by one or more sensors associated with a catheter and/or pump. The sensor may be a capacitive sensor, an analyte sensor, an optical sensor, or similar device for measuring the concentration of an analyte in urine. Similarly, as shown at block 1022, the patient's blood creatinine or hematocrit level may be analyzed based on information obtained from the patient monitoring sensors described above. For example, the capacitive sensor may be placed in an existing extracorporeal blood system. The information obtained by the capacitive sensor may be analyzed to determine the hematocrit ratio of the patient. The measured hematocrit ratio may be compared to certain expected or therapeutically acceptable values. The pump may continue to introduce negative pressure in the patient's ureters and/or kidneys until the obtained measurements are within a therapeutically acceptable range. Once a therapeutically acceptable value is obtained, introduction of negative pressure may be stopped, as indicated at block 1018.

In other embodiments, as shown in block 2024, the patient's weight may be measured to assess whether fluid has been removed from the patient by negative pressure therapy. For example, a measured weight of the patient (including fluid introduced during fluid resuscitation) may be compared to a dry weight of the patient. As used herein, dry body weight is defined as the normal body weight measured when the patient is not over-diluted. For example, a patient who is not experiencing one or more of the following symptoms and who is comfortable breathing may not have too much fluid: elevated blood pressure, dizziness or cramps, and swelling around the legs, feet, arms, hands or eyes. The body weight measured when the patient is free of these symptoms can be a dry body weight. The patient's weight may be measured periodically until the measured weight approaches a dry weight. As indicated at block 1018, when the measured weight approaches (e.g., between 5% and 10% of the dry body weight), the introduction of negative pressure may be stopped.

Experimental examples:

negative pressure was introduced into the renal pelvis of farm pigs to assess the effect of negative pressure therapy on renal congestion in the kidneys. The purpose of these studies was to ascertain whether the introduction of negative pressure within the renal pelvis would significantly increase urine volume in a pig kidney extravasated blood model. In example 1, the pediatric Fogarty catheter, which is typically used in embolectomy or bronchoscopy applications, is used in a pig model only to demonstrate the principle of introducing negative pressure within the renal pelvis. The use of Fogarty catheters in humans in a clinical setting is not recommended to avoid damage to urinary tract tissue. In example 2, a ureteral catheter 112 as shown in fig. 2A, 2B is used, which has a helical positioning portion for mounting or fixing the distal portion of the catheter in the renal pelvis or kidney.

Example 1

Method of producing a composite material

Four farm pigs 800 were used as the study subjects to evaluate the effect of negative pressure therapy on renal congestion in the kidneys. As shown in fig. 21,

pediatric Fogarty catheters

812, 814 are inserted into the

renal pelvis regions

820, 821 of each kidney 802, 804 of the four-headed pig 800. The dilation balloon is inflated to a size sufficient to seal the renal pelvis and maintain its position within the renal pelvis, thereby deploying the

catheters

812, 814 within the region of the renal pelvis.

Catheters

812, 814 extend from the renal pelvis 802, 804, through the bladder 810 and urethra 816, and to fluid collection reservoirs outside the pig.

Urine voided by both animals over a 15min period was collected to establish baseline voiding volumes and rates. Urine volumes were measured for the right kidney 802 and the left kidney 804, respectively, and were found to be very different. Creatinine clearance values were also determined.

Renal congestion (e.g., congestion or reduced blood flow in the renal veins) was induced in the right 802 and left 804 kidneys of animal 800 by partially occluding the Inferior Vena Cava (IVC) using an inflatable balloon catheter 850 directly above the renal vein outflow. The IVC pressure is measured with a pressure sensor. Normal IVC pressure is 1-4 mmHg. The IVC pressure is raised to 15-25mmHg by inflating the balloon of the catheter 850 to approximately three-quarters of the IVC diameter. Inflating the balloon to approximately three-quarters of the IVC diameter results in a 50% to 85% reduction in urine volume. Complete occlusion can result in IVC pressures in excess of 28mmHg and is associated with at least a 95% reduction in urine volume.

One kidney of each animal 800 was untreated and used as a control ("control kidney 802"). Ureteral catheter 812, which extends from the control kidney, is connected to fluid collection reservoir 819 to determine fluid levels. One kidney of each animal ("treatment kidney 804") is treated with negative pressure using negative pressure introduced by a negative pressure source connected to ureteral catheter 814 (e.g., treatment pump 818 in conjunction with a regulator designed to more precisely control the low negative pressure value). Pump 818 is an Air Cadet vacuum pump (model EW-07530-85) manufactured by Cole-Parmer Instrument company. A pump 818 is connected in series with the regulator. The regulator was a V-800 series miniature precision vacuum regulator-1/8 NPT port (model V-800-10-W/K) manufactured by airtrols Components.

The pump 818 is actuated to introduce negative pressure within the

renal pelvis

820, 821 of the treatment kidney according to the following protocol. First, the effect of negative pressure under normal conditions (e.g., without inflating the IVC balloon) was investigated. Four different pressure levels (-2, -10, -15 and-20 mmHg) were introduced for 15min, respectively, and urine production and creatinine clearance were determined. The pressure level is controlled and determined on the regulator. After-20 mmHg treatment, the IVC balloon was inflated to raise the pressure by 15-20 mmHg. The same four negative pressure levels were introduced. The voiding and creatinine clearance was obtained for both the extravasated control kidney 802 and the treated kidney 804. Animals 800 were hemorrhaged by partially blocking the IVC for 90 min. In the 90min blood stasis period, the treatment time is 60 min.

After urine volume and creatinine clearance data were collected, one animal was examined for gross renal status and then fixed in 10% neutral buffered formalin. After gross examination, tissue sections are acquired, examined, and magnified images of the sections are taken. Sections were examined using an upright Olympus BX41 light microscope and images were taken using an Olympus DP25 digital camera. Specifically, microscopic images of the sampled tissue were obtained at low magnification (20 times original magnification) and high magnification (100 times original magnification). The obtained images were evaluated histologically. The purpose of the assessment is to examine the tissue histologically and to characterize qualitatively the condition of the obtained samples as regards extravasated blood and renal tubule degeneration.

Surface mapping analysis was also performed on the obtained kidney tissue slides. Specifically, the samples were stained and analyzed to assess the difference in tubular size between treated and untreated kidneys. The number and/or relative percentage of pixels with different colors in the stain image is calculated using image processing techniques. The calculated measurement data are used to determine the volume of the different anatomical structures.

Results

Urine volume and creatinine clearance

The rate of urination varies greatly. Three sources of variability in voiding rates were observed over the course of the study. Variability in inter-individual and hemodynamic conditions is a source of expected variability known in the art. In the experiments discussed herein, a third source of urine volume change, i.e., change in urine volume in contralateral individuals, was identified based on information and beliefs believed to be previously unknown.

The baseline urination rate for one kidney was 0.79mL/min and the baseline urination rate for the other kidney was 1.07mL/min (e.g., a 26% difference). The urination rate refers to an average value calculated from the urination rate of each animal.

When extravasation was caused by inflating the IVC balloon, the voiding rate of the treated kidneys dropped from 0.79mL/min to 0.12mL/min (15.2% of baseline). In contrast, the urine output of the control kidney during the extravasation period decreased from 1.07mL/min to 0.09mL/min (8.4% of baseline). Based on the urinary rate, the relative increase in urinary rate of the treated kidney compared to the control kidney was calculated according to the following equation:

(treatment renal treatment/treatment renal baseline)/(control renal treatment/control renal baseline) ═ relative increase

(0.12ml/min/0.79ml/min)/(0.09ml/min/1.07ml/min)＝180.6％

Thus, the urinary output of the treated kidneys was relatively increased by 180.6% compared to the control kidneys. This result indicates that the decrease in urine production due to congestion was larger on the control side than on the treatment side. The results are shown as relative percentage difference in urine volume to accommodate the difference in urine volume between the kidneys.

Figure 22 shows creatinine clearance measurements for baseline, extravasation and treatment sites for one of the animals.

Gross examination and histological evaluation

Based on gross examination of the control kidney (right kidney) and the treated kidney (left kidney), it was determined that the control kidney was uniformly dark reddish brown, meaning that the control kidney was more congested than the treated kidney. Qualitative assessment of the magnified slice images also indicated that the control kidneys were more congested than the treated kidneys. Specifically, as shown in table 1, the treated kidneys exhibited a lower degree of extravasation and tubular degeneration than the control kidneys. The slides obtained were evaluated using the following qualitative scale.

Extravasated blood

Renal tubular degeneration

TABLE 1

Tabulated results

As shown in table 1, the treated kidney (left kidney) showed only mild congestion and tubular degeneration. In contrast, the control kidney (right kidney) showed moderate congestion and tubular degeneration. These results were obtained by analyzing the following slides.

Fig. 23A, 23B are low, high magnification micrographs of the left kidney of an animal (treated with negative pressure). From histological examination, mild extravasation of blood vessels at the cortical medullary junction was determined as indicated by the arrows. As shown in fig. 23B, a single renal tubule (identified by an asterisk) having a hyaline tubular shape has been identified.

Fig. 23C, 23D are low, high resolution photomicrographs of the control kidney (right kidney). From the histological examination, moderate extravasation of blood vessels at the cortical medullary junction was determined, as indicated by the arrows in fig. 23C. As shown in FIG. 23D, several renal tubules having a hyaline tubular shape (indicated by the star in the figure) were present in the tissue sample. The presence of a large number of hyaline casts provides evidence of hypoxia.

The results of the surface mapping analysis are as follows. The treatment kidneys were measured to have a 1.5-fold higher fluid volume in the renal capsule cavity and a 2-fold higher fluid volume in the renal capsule cavity. An increase in the amount of fluid in the renal capsule and renal tubule lumens corresponds to an increase in urine volume. In addition, the treated kidneys were determined to have 5-fold less capillary blood volume than the control kidneys. The increase in volume of the treated kidney appears to be due to the following reasons: (1) a reduction in size of individual capillaries compared to control kidneys; (2) the increase in the number of capillaries without visible erythrocytes in the treated kidney compared to the control kidney is an indicator of the reduction in congestion in the treated organ.

Summary of the invention

These results indicate that the control kidneys have more extravasation and more luminal hyaline casts which represent protein rich luminal material than the treated kidneys. Thus, the treated kidneys showed a lower degree of loss of renal function. While not wishing to be bound by theory, it is believed that organ hypoxemia follows with severe congestion of the kidneys. Hypoxemia interferes with oxidative phosphorylation (e.g., ATP production) within the organ. Loss of ATP and/or decreased ATP production inhibits active transport of proteins, resulting in increased levels of proteins in the lumen, which consequently appear as a hyaline cast. The number of luminal hyaline tubular tubules correlates with the degree of loss of renal function. Thus, a reduction in the number of tubules in the left kidney being treated is considered to be of physiological significance. While not wishing to be bound by theory, it is believed that these results indicate that damage to the kidney can be prevented or inhibited by introducing negative pressure in a catheter inserted into the renal pelvis to promote urinary drainage.

Example 2

Method of producing a composite material

Four (4) farm pigs (A, B, C, D) were sedated and anesthetized. Vital signs of each pig were monitored throughout the experiment and cardiac output was measured at the end of each 30min phase of the study. A ureteral catheter (e.g., ureteral catheter 112 as shown in fig. 2A, 2B) is deployed within the renal pelvis region of each pig's kidney, respectively. The deployed catheter was a 6Fr catheter with an outer diameter of (2.0 ± 0.1) mm. The catheter has a length of (54 ± 2) cm and does not include a distal positioning portion. The length of the positioning part is (16 +/-2) mm. As shown in the catheter 112 in fig. 2A, 2B, the positioning portion includes two full coils and one proximal half coil. The outside diameter of the full coil was (18. + -.2) mm, as shown by line D1 in FIGS. 2A and 2B. The diameter D2 of the half coil is about 14 mm. The positioning portion of the ureteral catheter has six drainage openings and an additional opening at the distal end of the catheter. The diameter of each liquid discharge opening was (0.83. + -. 0.01) mm. The distance between adjacent drainage openings 132, in particular the linear distance between the drainage openings 132 when the coil is straightened, is (22.5 ± 2.5) mm.

Ureteral catheters extend from the renal pelvis of the pigs, through the bladder and urethra, and to the external body fluid collection containers of each pig. After placement of the ureteral catheter, a pressure sensor for measuring IVC pressure is placed in the IVC away from the renal vein. Inflating balloon catheters, particularly those manufactured by NuMED of Hopkinton, N.Y.

Percutaneous balloon catheters (30 mm in diameter and 5cm in length) are expanded in IVC close to the renal vein. A thermodilution catheter, particularly the Swan-Ganz thermodilution pulmonary artery catheter manufactured by Edwards Lifesciences, Irvine, california, was then placed in the pulmonary artery to measure cardiac output.

Initially, baseline urine volume was measured for 30min and blood and urine samples were collected for biochemical analysis. After a baseline period of 30min, the balloon catheter was inflated to raise the IVC pressure from a baseline pressure of 1-4mmHg to a high extravasation pressure of about (20 ± 5) mmHg. The extravasated blood baseline was then collected for 30min and corresponding blood and urine analyses were performed.

At the end of the extravasated period, higher IVC extravasated blood pressure was maintained and negative pressure diuretic therapy was administered to pig A, C. Specifically, a negative pressure of-25 mmHg was introduced into the pig A, C body through the ureteral catheter using a pump for treatment. As described in the previous examples, the pump was an Air Cadet vacuum pump (model EW-07530-85) manufactured by Cole-Parmer Instrument company. The pump is connected in series with the regulator. The regulator was a V-800 series miniature precision vacuum regulator-1/8 NPT port (model V-800-10-W/K) manufactured by Airtrol Components. While treatment was provided, pigs were observed for 120 min. During the treatment period, blood and urine were collected every 30 min. Two pigs (B, D) were used as a extravasated blood control (e.g., no negative pressure was introduced into the renal pelvis through the ureteral catheter), meaning that these two pigs (B, D) did not receive negative pressure diuretic therapy.

Urine volume and creatinine clearance data were collected during 120min treatment, and animals were sacrificed and the kidneys of each animal were examined in general. Following gross examination, tissue sections are acquired for examination and magnified images of the sections are taken.

Results

Measurement data collected during baseline, extravasation and treatment are given in table 2. Specifically, measurements of urine volume, serum creatinine, and urine creatinine were obtained at each session. These values can be used to calculate creatinine clearance as follows:

in addition, a neutrophil gelatinase-associated lipoprotein (NGAL) value was measured from the serum sample obtained at each session, and a kidney injury molecule 1(KIM-1) value was measured from the urine sample obtained at each session. Table 2 also lists qualitative histological findings determined by observation of the obtained histological sections.

TABLE 2

Data are raw values (baseline percentage)

Unmeasured

Confusion with phenylephrine

Animal A: the animal weighed 50.6kg, baseline voidage was 3.01mL/min, baseline serum creatinine was 0.8mg/dl, and measured CrCl was 261 mL/min. Notably, these measurements were abnormally high with the exception of serum creatinine compared to other animals studied. Congestion was associated with a 98% decrease in voiding (0.06mL/min) and a more than 99% decrease in CrCl (1.0 mL/min). Treatment by introducing negative pressure in the ureteral catheter is associated with urine volume and CrCl at 17% and 12% of the baseline values, respectively, and also at 9-fold and over 10-fold of the extravasation value, respectively. NGAL levels varied throughout the experiment, ranging from 68% at baseline during extravasation to 258% at baseline after 90min of treatment. The final value was 130% of baseline. During the last three collection periods, KIM-1 levels were 6 and 4 times baseline before increasing to 68, 52 and 63 times baseline values, respectively, during the first two 30min window periods after baseline assessment. Serum creatinine was 1.3mg/dl for 2 h. Histological examination showed a total extravasated blood level of 2.4% as measured by blood volume in the lumen of the capillary. Histological examination also found that some of the tubules had luminal hyaline casts and some degree of tubular epithelial degeneration, a finding consistent with cellular injury.

Animal B: the animal weighed 50.2kg, baseline voiding rate was 2.62mL/min, and CrCl was measured at 172mL/min (also higher than expected). Congestion was associated with an 80% decrease in voiding (0.5mL/min) and an 83% decrease in CrCl (30 mL/min). At 50min of congestion (20 min after the baseline period of congestion), the mean arterial pressure and respiratory frequency of the animals suddenly dropped, followed by tachycardia. The anesthesiologist administered a dose of phenylephrine (75mg) to avoid cardiogenic shock. Phenylephrine may be used for intravenous injections when blood pressure drops below safe levels during anesthesia. However, since this experiment is testing the effect of congestion on kidney physiology, the administration of phenylephrine can confound the rest of the experiment.

Animal C: the animal weighed 39.8kg, baseline voidage was 0.47mL/min, baseline serum creatinine was 3.2mg/dl, and measured CrCl was 5.4 mL/min. Congestion was associated with a 75% decrease in voiding (0.12mL/min) and a 79% decrease in CrCl (1.6 mL/min). The results show that baseline NGAL levels are 5 times higher than the Upper Limit of Normal (ULN). Negative pressure treatment of the renal pelvis through the ureteral catheter was associated with normalization of urine volume (101% of baseline) and 341% improvement in CrCl (18.2 mL/min). NGAL levels varied throughout the experiment, ranging from 84% at baseline during extravasation to 47% to 84% at baseline at 30-90 min. The final value was 115% of baseline. The level of KIM-1 decreased 40% from baseline during the first 30min of extravasation and then increased 8.7, 6.7, 6.6 and 8 times the baseline value during the remaining 30min window, respectively. Serum creatinine level at 2h was 3.1 mg/dl. Histological examination showed a total extravasated blood level of 0.9% as measured by blood volume in the lumen of the capillary. Note that the renal tubules are histologically normal.

Animal D: the animal weighed 38.2kg, baseline voidage was 0.98mL/min, baseline serum creatinine was 1.0mg/dl, and measured CrCl was 46.8 mL/min. Congestion was associated with a 75% decrease in voiding (0.24mL/min) and a 65% decrease in CrCl (16.2 mL/min). Persistent congestion is associated with a 66% to 91% reduction in urine volume and 89% to 71% reduction in CrCl. The levels of NGAL varied throughout the experiment, ranging from 127% at baseline during the extravasation period to 209% at the final value. During the last three 30min, the KIM-1 level remained between 1 and 2 times the baseline before increasing to 190, 219 and 201 times the baseline value in the first two 30min window periods after baseline assessment. Serum creatinine level was 1.7mg/dl at 2 h. Histological examination showed that the total extravasation level was 2.44 times higher than that observed in the tissue sample of treated animal (A, C), while the average capillary size was 2.33 times larger than that observed in either of the two treated animals. Histological evaluation also found that some of the tubules had luminal hyaline casts and tubular epithelial degeneration, indicating the presence of substantial cellular injury.

Summary of the invention

While not wishing to be bound by theory, it is believed that the data collected supports the following assumptions: venous congestion has a physiologically significant effect on renal function. In particular, it was observed that the increase in renal venous pressure reduced urine volume by 75% to 98% within a few seconds. The correlation between increased biomarkers of renal tubular injury and histological injury is consistent with the degree of venous congestion produced, in terms of extent and duration of injury.

These data also appear to support the following assumptions: venous stasis reduces the filtration gradient of medullary nephrons by altering interstitial pressure. This change appears to directly result in hypoxia and cell damage within the medullary nephron. Although this model does not mimic the clinical situation of AKI, it does provide insight into mechanical sustained injury.

These data also appear to support the following assumptions: in the venous stasis model, introduction of negative pressure within the renal pelvis through the ureteral catheter can increase urine volume. In particular, negative pressure therapy is associated with increased urine volume and creatinine clearance, which will be clinically significant. A physiologically meaningful decrease in medullary capillary volume and a small amplitude increase in biomarkers of renal tubular injury were also observed. Thus, it appears that negative pressure therapy can be used to directly reduce congestion by increasing the rate of urination and reducing interstitial pressure within the medullary nephrons. While not wishing to be bound by theory, it may be concluded by the reduction of congestion that negative pressure therapy reduces the extent of hypoxia and its downstream effects in the kidney in venous congestion mediated AKI.

The experimental results appear to support the following assumptions: whether the pressure is high or low, the extent of the congestion is related to the extent of cell damage observed. In particular, a correlation was observed between the degree of urine volume reduction and histological lesions. For example, a treatment of pig a with a 98% reduction in urine volume suffers more damage than a treatment of pig C with a 75% reduction in urine volume. As expected, control D reduced urine volume by 75% within 2.5h without treatment, showing the greatest histological damage. These findings are generally consistent with human data, suggesting that as venous congestion increases, the risk of AKI onset increases. See, for example, Legend, M.et al, Association between system homographies and viral acid kidney in clinical letters: a retroactive adaptive studio.Critical Care17：R278-86，2013。

Example 3

Method of producing a composite material

To assess the effect of negative pressure therapy on blood dilution, negative pressure was introduced within the renal pelvis of farm pigs. The purpose of these studies was to ascertain whether introduction of negative pressure within the renal pelvis would significantly increase urine volume in a fluid-resuscitated pig model.

Both pigs were sedated and anesthetized with ketamine, midazolam, isoflurane and propofol. One animal was treated with the ureteral catheter and negative pressure therapy described herein (# 6543). The other received Foley type bladder catheters as controls (# 6566). After placing the catheter, the animals were transferred to slings and monitored for 24 h.

During the 24h follow-up period, saline (125mL/h) was continuously injected into both animals to cause fluid overload. Urine output was measured at 15min intervals for 24 h. Blood and urine samples were taken every 4 h. As shown in fig. 21, the treatment pump 818 is set to introduce negative pressure within the renal pelvis 820, 821 (shown in fig. 21) of both kidneys using a pressure of-45 mmHg (+ 2 mmHg).

Results

Both animals received 7L of saline over 24 h. The treated animals produced 4.22L of urine, while the control animals produced 2.11L of urine. At the end of 24h, the control animals retained 4.94L of the 7L dose, while the treated animals retained 2.81L of the 7L dose. Fig. 26 shows the change in serum albumin. Within 24h, the serum albumin concentration of the treated animals decreased by 6%, while the serum albumin concentration of the control animals decreased by 29%.

Summary of the invention

While not wishing to be bound by theory, it is believed that the data collected supports the following assumptions: fluid overload can have a clinically significant effect on kidney function and thus cause blood dilution. In particular, it was observed that even healthy kidneys are not able to effectively remove large amounts of i.v. saline. The resulting accumulation of fluid can lead to blood dilution. These data also appear to support the following assumptions: negative pressure diuretic therapy can increase urine volume in fluid-overloaded animals, improve net fluid balance, and reduce the effect of fluid resuscitation on the development of blood dilution.

The foregoing embodiments and implementations of the present invention have been described with reference to various embodiments. Modifications and alterations will occur to others upon reading and understanding the preceding detailed description. Therefore, the foregoing embodiments should not be construed as limiting the invention.

Claims

1. A method of promoting renal urination, comprising:

(a) inserting a catheter into at least one of a kidney, a renal pelvis, or a ureter proximate to the renal pelvis of a patient, wherein the catheter comprises:

a drainage lumen having a proximal portion and a distal portion located in a kidney, renal pelvis, and/or ureter proximate to the renal pelvis of a patient, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, wherein the funnel stent has a first diameter and a second diameter, and the first diameter is less than the second diameter, which is closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings; and

(b) applying negative pressure to a proximal portion of the drainage lumen for a period of time to promote urination of the kidney.

2. The method of claim 1, wherein the catheter blocks the ureter and/or kidney without preventing urine from flowing out of the ureter and/or kidney.

3. The method of claim 1, wherein the funnel holder is generally conical.

4. The method of claim 1, wherein the funnel holder is generally hemispherical.

5. The method of claim 1, wherein the funnel stent has a base adjacent the distal portion of the drainage lumen, the base having at least one opening aligned with an interior of the proximal portion of the drainage lumen to allow liquid to flow into the interior of the proximal portion of the drainage lumen.

6. The method of claim 5, wherein the at least one opening of the base is about 0.05mm to about 4mm in diameter.

7. The method of claim 1, wherein said at least one sidewall of said funnel support has a height along a central axis of said funnel support.

8. The method of claim 7, wherein the height of the at least one sidewall of the funnel support is from about 1mm to about 25 mm.

9. The method of claim 7, wherein a ratio between a height of the at least one sidewall of the funnel holder and the second diameter is about 1:25 to about 5: 1.

10. The method of claim 5, wherein the diameter of the at least one opening of the base is about 0.05mm to about 4mm, the height of the at least one sidewall of the funnel holder is about 1mm to about 25mm, and the second diameter of the funnel holder is about 5mm to about 25 mm.

11. The method of claim 1, wherein said at least one side wall of said funnel support is continuous along its height.

12. The method of claim 1, wherein the at least one side wall of the funnel support has a solid wall.

13. The method of claim 1, wherein the at least one sidewall of the funnel support is formed by a balloon.

14. The method of claim 1, wherein said at least one side wall of said funnel support is discontinuous along its height.

15. The method of claim 1, wherein the at least one sidewall of the funnel support has at least one opening.

16. The method of claim 1, wherein the at least one opening has an area of about 0.002mm²To about 100mm²。

17. The method of claim 1, wherein the at least one sidewall of the funnel support comprises at least a first coil having a first diameter and a second coil having a second diameter, and the first diameter is less than the second diameter; wherein a maximum distance between a portion of a sidewall of the first coil and a portion of an adjacent sidewall of the second coil is about 0mm to about 10 mm.

18. The method of claim 17, wherein the first diameter of the first coil is about 1mm to about 10mm and the second diameter of the second coil is about 5mm to about 25 mm.

19. The method of claim 17, wherein the diameter of the coil increases in a direction toward the distal end of the drainage lumen, thereby forming a helix having a tapered or partially tapered configuration.

20. The method of claim 1, wherein the at least one sidewall of the funnel stent has a mesh with a plurality of openings therethrough to allow fluid to flow into the drainage lumen; wherein the maximum area of the opening is up to about 100mm²。

21. The method of claim 1, wherein the at least one sidewall of the funnel stent has an inward side and an outward side, the inward side having at least one opening that allows liquid to flow into the drainage lumen, and the outward side having no or substantially no openings.

22. The method of claim 21, wherein the at least one opening has an area of about 0.002mm²To about 100mm²。

23. The method of claim 17, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen.

24. The method of claim 17, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least two openings to allow liquid to flow into the drainage lumen.

25. The method of claim 17, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially outward side of the first coil is free or substantially free of one or more openings.

26. The method of claim 17, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow liquid to flow into the drainage lumen, the radially outward side being free or substantially free of one or more openings.

27. The method of claim 15, wherein the at least one opening in the sidewall of the drainage lumen allows liquid to flow into the drainage lumen under negative pressure.

28. The method of claim 1, wherein the positioning portion of the drainage lumen further has an open distal end to allow fluid to flow into the drainage lumen.

29. The method of claim 1, wherein the funnel stent has at least a third diameter, and the third diameter is smaller than the second diameter, the third diameter being closer to an end of the distal portion of the drainage lumen than the second diameter.

30. The method of claim 15, wherein the one or more openings are circular.

31. The method of claim 15, wherein the one or more openings are non-circular.

32. The method of claim 1, wherein the at least one sidewall of the funnel support is convex.

33. The method of claim 1, wherein the at least one sidewall of the funnel support is concave.

34. The method of claim 1, wherein a central axis of the funnel stent is offset from a central axis of the tube of the drainage lumen.

35. The method of claim 1, wherein said distal end of said positioning portion of said funnel support has a plurality of substantially rounded edges.

36. The method of claim 1, wherein the at least one sidewall of the funnel support has a plurality of lobe-shaped longitudinal pleats.

37. The method of claim 36, wherein the at least one burst-shaped longitudinal pleat has at least one longitudinal support.

38. The method of claim 36, wherein the distal end of the at least one burst-shaped longitudinal pleat has at least one support.

39. The method of claim 1, wherein the at least one sidewall of the funnel support comprises an inner sidewall and an outer sidewall, the inner sidewall having at least one opening to allow liquid to flow therethrough into the interior of the proximal portion of the drainage lumen.

40. The method of claim 1, wherein the funnel support comprises a porous material located inside the sidewall.

41. The method of claim 1, wherein the funnel support comprises a porous liner located adjacent an interior of the sidewall.

42. The method of claim 1, wherein said catheter is convertible between a collapsed configuration for insertion into a patient ureter and an expanded configuration for deployment within said ureter.

43. The method of claim 1, wherein the drainage lumen is made at least in part of one or more materials of copper, silver, gold, nitinol, stainless steel, titanium, polyurethane, polyvinyl chloride, Polytetrafluoroethylene (PTFE), latex, and silicone.

44. A ureteral catheter, comprising:

a drainage lumen having a proximal portion and a distal portion located in a kidney, renal pelvis, and/or ureter proximate to the renal pelvis of a patient, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings.

45. The ureteral catheter of claim 44, wherein the catheter blocks the ureter and/or kidney without preventing urine from flowing out of the ureter and/or kidney.

46. The ureteral catheter of claim 44, wherein the funnel stent is generally conical.

47. The ureteral catheter of claim 44, wherein the funnel stent is generally hemispherical.

48. The ureteral catheter of claim 44, wherein the funnel stent has a base adjacent the distal portion of the drainage lumen, the base having at least one opening aligned with an interior of the proximal portion of the drainage lumen to allow liquid to flow into the interior of the proximal portion of the drainage lumen.

49. The ureteral catheter of claim 48, wherein the diameter of the at least one opening of the base is from about 0.05mm to about 4 mm.

50. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has a height along a central axis of the funnel stent.

51. The ureteral catheter of claim 50, wherein the height of the at least one sidewall of the funnel stent is from about 1mm to about 25 mm.

52. The ureteral catheter of claim 50, wherein a ratio between the height of the at least one sidewall of the funnel stent and the second diameter is about 1:25 to about 5: 1.

53. The ureteral catheter of claim 48, wherein the diameter of the at least one opening of the base is from about 0.05mm to about 4mm, the height of the at least one sidewall of the funnel stent is from about 1mm to about 25mm, and the second diameter of the funnel stent is from about 5mm to about 25 mm.

54. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is continuous along its height.

55. The ureteral catheter of claim 44, wherein the at least one side wall of the funnel stent has a solid wall.

56. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is formed from a balloon.

57. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is discontinuous along its height.

58. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has at least one opening.

59. The ureteral catheter of claim 44, wherein the area of the at least one opening is about 0.002mm²To about 100mm²。

60. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent comprises at least a first coil having a first diameter and a second coil having a second diameter, and the first diameter is less than the second diameter; wherein a maximum distance between a portion of a sidewall of the first coil and a portion of an adjacent sidewall of the second coil is about 0mm to about 10 mm.

61. The ureteral catheter of claim 60, wherein the first diameter of the first coil is from about 1mm to about 10mm, and the second diameter of the second coil is from about 5mm to about 25 mm.

62. The ureteral catheter of claim 60, wherein the diameter of the coil increases toward a distal end of the drainage lumen, thereby forming a helical structure having a tapered or partially tapered configuration.

63. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has a mesh, the meshThe mesh having a plurality of openings therethrough to allow liquid to flow into the drainage lumen; wherein the maximum area of the opening is up to about 100mm²。

64. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has an inward side and an outward side, the inward side having at least one opening that allows fluid to flow into the drainage lumen, and the outward side being free or substantially free of openings.

65. The ureteral catheter of claim 64, wherein the area of the at least one opening is about 0.002mm²To about 100mm²。

66. The ureteral catheter of claim 60, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen.

67. The ureteral catheter of claim 60, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least two openings to allow fluid to flow into the drainage lumen.

68. The ureteral catheter of claim 60, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially outward side of the first coil is free of, or substantially free of, one or more openings.

69. The ureteral catheter of claim 60, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen, the radially outward side being free or substantially free of one or more openings.

70. The ureteral catheter of claim 58, wherein the at least one opening in the sidewall of the drainage lumen allows liquid to flow into the drainage lumen under the influence of negative pressure.

71. The ureteral catheter of claim 44, wherein the positioning portion of the drainage lumen further has an open distal end to allow fluid to flow into the drainage lumen.

72. The ureteral catheter of claim 4, wherein the funnel stent has a third diameter, and the third diameter is smaller than the second diameter, the third diameter being closer to an end of the distal portion of the drainage lumen than the second diameter.

73. The ureteral catheter of claim 58, wherein the one or more openings are circular.

74. The ureteral catheter of claim 58, wherein the one or more openings are non-circular.

75. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is convex.

76. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent is concave.

77. The ureteral catheter of claim 44, wherein a central axis of the funnel stent is offset from a central axis of the tube of the drainage lumen.

78. The ureteral catheter of claim 44, wherein the distal end of the positioning portion of the funnel stent has a plurality of substantially rounded edges.

79. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent has a plurality of lobe-shaped longitudinal pleats.

80. The ureteral catheter of claim 79, wherein the at least one split-shaped longitudinal pleat has at least one longitudinal support.

81. The ureteral catheter of claim 79, wherein the distal end of the at least one split-shaped longitudinal pleat has at least one support.

82. The ureteral catheter of claim 44, wherein the at least one sidewall of the funnel stent comprises an inner sidewall and an outer sidewall, the inner sidewall having at least one opening to allow liquid to flow therethrough into an interior of the proximal portion of the drainage lumen.

83. The ureteral catheter of claim 44, wherein the funnel stent comprises a porous material located inside the sidewall.

84. The ureteral catheter of claim 44, wherein the funnel stent comprises a porous liner located adjacent to an interior of the sidewall.

85. The ureteral catheter of claim 44, wherein the catheter is transitionable between a collapsed configuration for insertion into a patient ureter and an expanded configuration for deployment within the ureter.

86. The ureteral catheter of claim 44, wherein the drainage lumen is made at least partially from one or more materials of copper, silver, gold, nickel titanium alloy, stainless steel, titanium, polyurethane, polyvinyl chloride, Polytetrafluoroethylene (PTFE), latex, and silicone.

87. A system for introducing negative pressure in a portion of a urinary tract of a patient, the system comprising:

at least one ureteral catheter having a drainage lumen having a proximal portion and a distal portion located in a patient's kidney, renal pelvis, and/or ureter proximate to the renal pelvis, the distal portion comprising a positioning portion comprising a funnel stent having at least one sidewall, the funnel stent having a first diameter and a second diameter, and the first diameter being less than the second diameter, the second diameter being closer to an end of the distal portion of the drainage lumen than the first diameter, wherein the proximal portion of the drainage lumen is free or substantially free of openings and extends to a deployed position enabling the diameter of the positioning portion to be greater than the diameter of the drainage lumen, wherein the funnel stent has at least one drainage opening to allow fluid to flow into the drainage lumen; and

a pump in fluid communication with the proximal portion of the drainage lumen, the pump configured to introduce negative pressure in a portion of a urinary tract of a patient to draw liquid through the drainage lumen of the ureteral catheter.

88. The system of claim 87, wherein the catheter blocks the ureter and/or kidney without preventing urine from flowing out of the ureter and/or kidney.

89. The system of claim 87, wherein the funnel support is generally conical.

90. The system of claim 87, wherein the funnel holder is generally hemispherical.

91. The system of claim 87, wherein the funnel stent has a base adjacent the distal portion of the drainage lumen, the base having at least one opening aligned with an interior of the proximal portion of the drainage lumen to allow liquid to flow into the interior of the proximal portion of the drainage lumen.

92. The system of claim 91, wherein the at least one opening of the base has a diameter of about 0.05mm to about 4 mm.

93. The system of claim 87, wherein the at least one sidewall of the funnel support has a height along a central axis of the funnel support.

94. The system of claim 93, wherein the height of said at least one side wall of said funnel support is from about 1mm to about 25 mm.

95. The system of claim 93, wherein a ratio between a height of said at least one sidewall of said funnel support and said second diameter is about 1:25 to about 5: 1.

96. The system of claim 91, wherein the at least one opening of the base is about 0.05mm to about 4mm in diameter, the at least one sidewall of the funnel support is about 1mm to about 25mm in height, and the second diameter of the funnel support is about 5mm to about 25 mm.

97. The system of claim 87, wherein the at least one side wall of the funnel support is continuous along its height.

98. The system of claim 87, wherein the at least one side wall of the funnel support has a solid wall.

99. The system of claim 87, wherein the at least one sidewall of the funnel support is formed by a balloon.

100. The system of claim 87, wherein the at least one sidewall of the funnel support is discontinuous along its height.

101. The system of claim 87, wherein the at least one sidewall of the funnel support has at least one opening.

102. The system of claim 87, wherein the at least one opening has an area of about 0.002mm²To about 100mm²。

103. The system of claim 87, wherein the at least one sidewall of the funnel support comprises at least a first coil having a first diameter and a second coil having a second diameter, and the first diameter is less than the second diameter; wherein a maximum distance between a portion of a sidewall of the first coil and a portion of an adjacent sidewall of the second coil is about 0mm to about 10 mm.

104. The system of claim 103, wherein the first diameter of the first coil is about 1mm to about 10mm and the second diameter of the second coil is about 5mm to about 25 mm.

105. The system of claim 103, wherein the diameter of the coil increases in a direction toward a distal end of the drainage lumen, thereby forming a helix having a tapered or partially tapered configuration.

106. The system of claim 87, wherein the at least one sidewall of the funnel support has a mesh with a plurality of openings therethrough to allow fluid to flow into the drainage lumen; wherein the maximum area of the opening is up to about 100mm²。

107. The system of claim 87, wherein the at least one sidewall of the funnel support has an inward side and an outward side, the inward side having at least one opening that allows fluid to flow into the drainage lumen, and the outward side having no or substantially no openings.

108. The system of claim 107, wherein the at least one opening has an area of about 0.002mm²To about 100mm²。

109. The system of claim 103, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen.

110. The system of claim 103, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least two openings to allow fluid to flow into the drainage lumen.

111. The system of claim 103, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially outward side of the first coil is free or substantially free of one or more openings.

112. The system of claim 103, wherein the sidewall of the first coil has a radially inward side and a radially outward side, and the radially inward side of the first coil has at least one opening to allow fluid to flow into the drainage lumen, the radially outward side being free or substantially free of one or more openings.

113. The system of claim 101, wherein the at least one opening in the sidewall of the drainage lumen allows liquid to flow into the drainage lumen under negative pressure.

114. The system of claim 87, wherein the positioning portion of the drainage lumen further has an open distal end to allow fluid to flow into the drainage lumen.

115. The system of claim 87, wherein the funnel stent has a third diameter, and the third diameter is smaller than the second diameter, the third diameter being closer to an end of the distal portion of the drainage lumen than the second diameter.

116. The system of claim 101, wherein the one or more openings are circular.

117. The system of claim 101, wherein the one or more openings are non-circular.

118. The system of claim 87, wherein the at least one sidewall of the funnel support is convex.

119. The system of claim 87, wherein the at least one sidewall of the funnel support is concave.

120. The system of claim 87, wherein a central axis of the funnel stent is offset from a central axis of the tube of the drainage lumen.

121. The system of claim 87 wherein the distal end of the positioning portion of the funnel support has a plurality of substantially rounded edges.

122. The system of claim 87, wherein the at least one sidewall of the funnel support has a plurality of lobe-shaped longitudinal pleats.

123. The system of claim 122, wherein the at least one burst-shaped longitudinal pleat has at least one longitudinal support.

124. The system of claim 122, wherein the distal end of the at least one split-shaped longitudinal pleat has at least one support.

125. The system of claim 87, wherein the at least one side wall of the funnel support comprises an inner side wall and an outer side wall, the inner side wall having at least one opening to allow liquid to flow therethrough into the interior of the proximal portion of the drainage lumen.

126. The system of claim 87, wherein the funnel support comprises a porous material positioned inside the sidewall.

127. The system of claim 87, wherein the funnel support comprises a porous liner located adjacent an interior of the sidewall.

128. The system of claim 87, wherein the catheter is transitionable between a collapsed configuration for insertion into a patient ureter and an expanded configuration for deployment within the ureter.

129. The system of claim 87, wherein the drainage lumen is made at least in part of one or more materials of copper, silver, gold, nitinol, stainless steel, titanium, polyurethane, polyvinyl chloride, Polytetrafluoroethylene (PTFE), latex, and silicone.