JP2020531149A - Ureter and bladder catheters and methods that induce negative pressure and increase renal perfusion - Google Patents

Abstract

(A) A drainage lumen, including a distal portion and a proximal portion, configured to be located in the patient's kidney, renal pelvis, and / or in the urinary tract adjacent to the renal pelvis. Includes a retaining portion, including a funnel-shaped support, including at least one side wall, the funnel-shaped support comprising a first diameter and a second diameter, the first diameter being the second. Less than the diameter, the second diameter is closer to the end of the distal portion of the drainage lumen than the first diameter, and the proximal portion of the drainage lumen has essentially no or no opening. Urination from the kidney, including the step of inserting a catheter, including the drainage lumen, and (b) applying negative pressure to the proximal portion of the drainage lumen over a time cycle to promote urination from the kidney. A method for facilitating is provided.

Description

(Cross-reference of related applications)
U.S. Provisions No. 62 / 300,025, filed February 25, 2016, filed January 14, 2016, respectively, which are incorporated herein by reference in their entirety. U.S. Provisional Application Nos. 62 / 278,721, U.S. Provisional Application No. 62 / 260,966 filed on November 30, 2015, and U.S. Provisional Application No. 62/194 filed on July 20, 2015. , 585, a partial continuation of U.S. Patent Application No. 15 / 214,955 filed on July 20, 2016, U.S. Patent Application No. 15 / filed on January 20, 2017. Claims the benefit of US Patent Application No. 15 / 687,064, filed August 25, 2017, which is a partial continuation of No. 411,884.

The present disclosure relates to methods and devices for treating impaired renal function across various disease states, in particular urine collection and / or renal, renal pelvis, and / or negative pressure in the urinary tract. Concerning catheter devices, assemblies, and methods for induction.

The kidneys or urinary system include a pair of kidneys, each of which is connected to the bladder by the ureter and to the urethra to drain the urine produced by the bladder. The kidneys perform several important functions for the human body, including, for example, filtering blood and eliminating waste in the form of urine. The kidney also regulates electrolytes (eg, sodium, potassium, and calcium) and metabolites, blood volume, blood pressure, blood pH, fluid volume, red blood cell production, and bone metabolism. A proper understanding of the anatomy and physiology of the kidney is useful for understanding the effects of altered hemodynamics and other volume overload conditions on its function.

In normal anatomy, the two kidneys are located intraperitoneally after the peritoneum. The kidney is a bean-shaped encapsulated organ. Urine is formed by the renal unit, which is the functional unit of the kidney, and then flows through a convergent tubular system called the collecting duct. The collecting ducts join together to form the small calyx, then the calyx, and finally near the concave part of the kidney (renal pelvis). The main function of the renal pelvis is to direct the urinary flow to the ureter. Urine flows from the renal pelvis into the ureter, a tube-like structure that transports urine from the kidneys into the bladder. The outer layer of the kidney, called the exodermis, is a rigid fibrous capsule. The inside of the kidney is called the medulla. The medulla structure is arranged in a pyramidal shape.

Each kidney is composed of about one million kidney units. A schematic diagram of renal unit 1102 is shown in FIG. Each renal unit includes glomeruli 1110, Bowman's capsule 1112, and renal tubules 1114. The tubule 1114 includes a proximal curved tubule 1116, a loop of Henle 1118, a distal curved tubule 1120, and a collecting duct 1122. The renal unit 1102 contained in the integumental layer of the kidney is distinctly different from the anatomical structure of what is contained in the medulla. The main difference is the length of the loop of Henle 1118. The medullary renal unit contains a longer loop of Henle, which allows better regulation of water and sodium reabsorption than the exodermal renal unit under normal conditions.

The glomerulus is the origin of the renal unit and is involved in the initial filtration of blood. Afferent arterioles allow blood to pass through glomerular capillaries, where hydrostatic pressure pushes water and solutes into Bowman's capsule. The net filtration pressure is expressed as the hydrostatic pressure in the afferent arterioles minus the hydrostatic pressure in the Bowman's space minus the osmotic pressure in the efferent arterioles.
Net filtration pressure = hydrostatic pressure (afferent arteriole) -hydrostatic pressure (Bowman's capsule)-
Osmotic pressure (efferent arteriole) (Equation 1)

The magnitude of the net filtration pressure defined by Equation 1 determines the amount of ultrafiltration fluid formed in the Bowman's space and delivered to the renal tubules. The remaining blood exits the glomerulus via the efferent arterioles. Normal glomerular filtration, i.e. delivery of ultrafiltration into the renal tubules, is approximately 90 ml / min / 1.73 m ² .

The glomerulus has a three-layer filtration structure and includes vascular endothelium, glomerular basement membrane, and podocytes. Normally, giant proteins such as albumin and red blood cells are not filtered into Bowman's space. However, elevated glomerular pressure and glomerular interstitial expansion result in surface area changes on the basement membrane, allowing larger fenestrations between podocytes to allow larger proteins to pass through the Bowman's space. To do.

The ultrafiltration fluid collected in the Bowman's space is first delivered to the proximal tubule. Reabsorption and secretion of water and solutes in the renal tubules is carried out by mixing active transport channels and passive pressure gradients. Proximal tubules usually reabsorb most of the sodium chloride and water and almost all glucose and amino acids filtered by the glomerulus. The loop of Henle has two components designed to concentrate waste in the urine. The descending limb is highly water permeable and reabsorbs most of the remaining water. The ascending limb reabsorbs 25% of the remaining sodium chloride and produces concentrated urine, for example in terms of urea and creatinine. Distal convoluted tubules usually reabsorb a small proportion of sodium chloride, and the osmotic gradient provides the conditions for water to follow.

Under normal conditions, there is a net filtration of about 14 mmHg. The effect of venous stagnation can be a significant reduction in net filtration up to about 4 mmHg. Jesus M. , The cardioreral syndrome: Do we need a change of strategy or a change of tactics? , JACC 53 (7): 597-600, 2009 (hereinafter “Jessup”). The second filtration step occurs in the proximal tubule. Most of the secretion and absorption from urine occurs in the renal tubules within the medulla renal unit. Active transport of sodium from the renal tubules into the interstitial cavity initiates this process. However, hydrostatic power influences the net exchange of solutes and water. Under normal conditions, 75% of sodium is believed to be reabsorbed into the lymphatic or venous circulation. However, because the kidneys are encapsulated, they are sensitive to changes in hydrostatic pressure from both venous and lymphatic stagnation. During venous stagnation, sodium and water retention can exceed 85%, further prolonging renal stagnation. Verbrugge et al. , The kidney in kidney heart failure: Are natururesis, sodium, and diruetucs really the good, the bad and the ugly? Please refer to European Journal of Heart Failure 2014: 16,133-42 (hereinafter, "Verbrugge").

Venous stagnation can lead to the prerenal form of acute kidney injury (AKI). Prerenal AKI results from loss of perfusion (or loss of blood flow) through the kidney. Many clinicians focus on the lack of fluidity into the kidney due to shock. However, there is also evidence that lack of blood flow from organs due to venous stagnation can be a clinically significant persistent injury. Dammann K, Import of venous connection for worsening renal function in advanced decompensated heart firefare, JACC17: 589-96, 2009 (see Dammann K, Impenous cohesion for worsening renal function in advanced decompensated heart failure, JACC17: 589-96, 2009

Prerenal AKI occurs across a wide variety of diagnoses and requires critical care hospitalization. The most prominent hospitalizations are for sepsis and acute decompensated heart failure (ADHF). Additional hospitalizations include cardiovascular surgery, general surgery, cirrhosis, trauma, burns, and pancreatitis. Symptoms of these disease states vary widely in clinical practice, but what they have in common is an increase in central venous pressure. In the case of ADHF, the increase in central venous pressure caused by heart failure leads to pulmonary edema, followed by dyspnea, which in turn requires hospitalization. In the case of sepsis, elevated central venous pressure is primarily the result of large doses of rapid infusion. Persistent injury is venous stagnation and results in improper perfusion, regardless of whether the primary invasion is hypovolemia due to hypovolemia or sodium and fluid retention.

Hypertension is another widely recognized condition that causes perturbations within the active and passive transport systems of the kidney. Hypertension directly affects afferent arteriole pressure, resulting in a proportional increase in net filtration pressure in the glomerulus. The increased filtration rate also increases peritubular capillary pressure, which stimulates sodium and water reabsorption. See Verbrugge.

Since the kidney is an encapsulated organ, it is sensitive to pressure changes within the medulla pyramid. Elevated renal vein pressure results in stagnation leading to increased interstitial pressure. The increase in interstitial pressure exerts force on both the glomerulus and the renal tubules. See Verburge. In the glomerulus, the increase in interstitial pressure directly opposes filtration. Increased pressure increases the interstitial fluid, thereby increasing the interstitial fluid in the renal medulla and the hydrostatic pressure in the peritubular capillaries. In both cases, hypoxia can ensure that it leads to cytotoxicity and further loss of perfusion. The net result is a further deterioration of sodium and water reabsorption, which provides negative feedback. See Verbrugge (133-42). In particular, intra-abdominal fluid volume overload is associated with many diseases and conditions, including elevated intra-abdominal pressure, abdominal compartment syndrome, and acute renal failure. Volume overload can be addressed through renal replacement therapy. Peters, C.I. D. , Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartanon Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (SAFIR Study), PLoS ONE (2015) 10 (6): e0126882. doi: 10.131 / journal. pone. See 0126882 (hereinafter “Peters”). However, such clinical strategies do not provide any improvement in renal function in patients with cardiorenal syndrome. See Bart B, Ultrafiltration in decompensated heart failure with cardioral syndrome, NEJM 2012; 367: 2296-2304 (hereinafter “Bart”).

Devices and methods for improving the removal of urine from the urethra, specifically to increase the quantity and quality of urination from the kidneys, in the light of such problematic effects of fluid retention. Needed.

Jesus M. , The cardioreral syndrome: Do we need a change of strategy or a change of tactics? , JACC53 (7): 597-600, 2009

In some embodiments, it is a method for facilitating urination from the kidney, in which (a) a catheter is inserted into the patient's kidney, renal pelvis, or at least one in the urinary tract adjacent to the renal pelvis. The catheter comprises a drainage lumen, including a distal portion and a proximal portion, configured to be located in the patient's kidney, intrarenal pelvis, and / or in the urinary tract adjacent to the renal pelvis. The distal portion comprises a retaining portion, comprising a funnel-shaped support having at least one side wall, the funnel-shaped support comprising a first diameter and a second diameter, the first diameter being: Is the second diameter less than the second diameter, the second diameter closer to the end of the distal portion of the drainage lumen than the first diameter, and the proximal portion of the drainage lumen essentially free of openings? A method is provided that includes, or not, a step (b) applying negative pressure to the proximal portion of the drainage lumen over a time cycle to promote urination from the kidney.

In some embodiments, a ureteral catheter comprises a distal portion and a proximal portion configured to be located in the patient's kidney, intrarenal pelvis, and / or in the ureter adjacent to the renal pelvis. , A drainage lumen, the distal portion of which comprises a funnel-shaped support, the distal portion of which comprises at least one side wall, the funnel-shaped support having a first diameter and a second diameter. The first diameter is less than the second diameter, the second diameter is closer to the end of the distal portion of the ureter than the first diameter, and the proximal portion of the ureter is A ureteral catheter is provided that comprises a drainage lumen with essentially no or no opening.

In some embodiments, it is a system for inducing negative pressure within a portion of the patient's urinary tract and is configured to be located in the patient's kidney, in the renal pelvis, and / or in the ureter adjacent to the renal pelvis. At least one ureteral catheter with a drainage lumen, comprising a distal portion and a proximal portion, the distal portion comprising a funnel-shaped support with at least one side wall, retaining. The funnel-shaped support comprising a portion comprises a first diameter and a second diameter, the first diameter being less than the second diameter and the second diameter being greater than the first diameter. Close to the end of the distal portion of the ureter, the proximal portion of the ureter is in a deployment position with essentially no or no openings and the diameter of the retention is greater than the diameter of the ureter. Constructed to be extended, the funnel-shaped support comprises at least one ureteral catheter and drainage with at least one drainage opening to allow fluid to flow into the drainage lumen. A pump that communicates fluidly with the proximal portion of the lumen and is configured to induce negative pressure within a portion of the patient's urinary tract and draw fluid through the drainage lumen of the ureteral catheter. A system is provided.

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

In some embodiments, a method for extracting urine from a patient's ureter and / or kidney to provide interstitial pressure in the kidney, where (a) a catheter is placed in the patient's kidney, renal pelvis,. Or in the step of inserting into at least one of the ureters adjacent to the renal pelvis, the catheter is configured to be located in the patient's kidney, in the renal pelvis, and / or in the ureter adjacent to the renal pelvis. It has a drainage lumen with a position portion and a proximal portion, the distal portion has at least one side wall, has a funnel-shaped support, has a retaining portion, and the funnel-shaped support is a first. It comprises a diameter and a second diameter, the first diameter being less than the second diameter, the second diameter being closer to the end of the distal portion of the ureter than the first diameter. The proximal portion of the drainage lumen is between the step and (b) the proximal portion of the drainage lumen, where negative pressure is applied over the time cycle and within the patient's kidney, with or without an opening. Methods are provided that include the steps of modifying the quality pressure.

In some examples, by applying negative pressure to reduce stromal pressure in the tubules of the medulla region, promote urination, and prevent venous stasis-induced renal unit hypoxia in the renal medulla. A method for preventing kidney damage, (a) a step of inserting a catheter into at least one of the patient's kidney, renal pelvis, or urinary tract adjacent to the renal pelvis. Into the kidney, in the renal pelvis, and / or in the urinary tract adjacent to the renal pelvis, with a distal portion and a proximal portion, with a drainage lumen, the distal portion at least one With side walls, with a funnel-shaped support, with a retaining portion, the funnel-shaped support has a first diameter and a second diameter, the first diameter being less than the second diameter. The second diameter is closer to the end of the distal portion of the drainage lumen than the first diameter, and the proximal portion of the drainage lumen is essentially free or absent of openings, with the step, (b. ) A method is provided that comprises applying negative pressure to the proximal portion of the drainage lumen over a time cycle to promote urination from the kidney.

In some examples, it is a method for the treatment of acute renal injury due to venous stasis, where (a) a catheter is placed in the patient's kidney, renal pelvis, or at least one in the urinary tract adjacent to the renal pelvis. A drainage tube comprising a distal portion and a proximal portion, the catheter being configured to be located in the patient's kidney, in the renal pelvis, and / or in the urinary tract adjacent to the renal pelvis. The distal portion comprises a cavity, the distal portion comprises at least one side wall, the funnel-shaped support has a retaining portion, and the funnel-shaped support has a first diameter and a second diameter, the first. The diameter of is less than the second diameter, the second diameter is closer to the end of the distal portion of the drainage lumen than the first diameter, and the proximal portion of the drainage lumen is essentially an opening. Intra-kidney to promote urination from the kidney and treat acute renal injury by applying negative pressure to the proximal portion of the drainage lumen over a step and (b) time cycle, either not or not. Methods are provided that include steps to reduce venous stagnation.

In some examples, it is a method for the treatment of New York Cardiac Association (NYHA) Class III and / or Class IV heart failure through reduction of venous stagnation in the renal pelvis, (a) catheterizing the patient. A step of insertion into the kidney, renal pelvis, or at least one of the urinary tracts adjacent to the renal pelvis, the catheter being configured to be located in the patient's kidney, renal pelvis, and / or urinary tract adjacent to the renal pelvis. The distal portion comprises a drainage lumen, the distal portion comprises at least one side wall, the pelvic support comprises a retaining portion, the pelvic support comprises a distal portion and a proximal portion. , A first diameter and a second diameter, the first diameter being less than the second diameter, the second diameter being the end of the distal portion of the drainage lumen from the first diameter. Close to the portion, the proximal portion of the drainage lumen is stepped and (b) a negative pressure is applied to the proximal portion of the drainage lumen over a predetermined time cycle, with or without an opening. Methods are provided that include the steps of treating volume overload in NYHA Class III and / or Class IV heart failure.

In some embodiments, methods for the treatment of stage 4 and / or stage 5 chronic kidney disease through reduction of venous stagnation in the renal pelvis, (a) catheterizing the patient's kidney,. A step of insertion into the renal pelvis, or at least one of the urinary tracts adjacent to the renal pelvis, the catheter is configured to be located in the patient's kidney, renal pelvis, and / or the urinary tract adjacent to the renal pelvis. , With a distal portion and a proximal portion, with a drainage lumen, the distal portion with at least one side wall, with a funnel-shaped support, with a retaining portion, the funnel-shaped support It comprises one diameter and a second diameter, the first diameter being less than the second diameter, and the second diameter being at the end of the distal portion of the drainage lumen from the first diameter. Nearly, the proximal part of the drainage lumen is staged by applying negative pressure to the proximal portion of the drainage lumen over a step and (b) predetermined time cycle, with or without an opening essentially. Methods are provided that include the steps of treating 4 and / or stage 5 chronic kidney disease.

Non-limiting examples, aspects, or embodiments of the present invention will now be described in the appendices numbered below.

Appendix 1: A method for facilitating urination from the kidney, which is (a) a step of inserting a catheter into the patient's kidney, renal pelvis, or at least one of the urinary tracts adjacent to the renal pelvis. The catheter comprises a distal portion and a proximal portion, the distal portion comprises a drainage lumen, configured to be located within the patient's kidney, renal pelvis, and / or the urinary tract adjacent to the renal pelvis. The funnel-shaped support has a first diameter and a second diameter, the first diameter being the second diameter, with a retaining portion, with at least one side wall, with a funnel-shaped support. Less than, the second diameter is closer to the end of the distal portion of the drainage lumen than the first diameter, and the proximal portion of the drainage lumen has essentially no or no opening, step And (b) a method comprising applying a negative pressure to the proximal portion of the drainage lumen over a time cycle to promote urination from the kidney.

Appendix 2: The method of Appendix 1, wherein the flow of urine from the ureter and / or kidney is not impeded by obstruction of the ureter and / or kidney by a catheter.

Appendix 3: The method according to Appendix 1, wherein the funnel-shaped support has a substantially conical shape.

Appendix 4: The method according to Appendix 1, wherein the funnel-shaped support has a substantially hemispherical shape.

Appendix 5. The funnel-shaped support comprises a base portion adjacent to the distal portion of the drain lumen, which drains to allow fluid to flow inside the proximal portion of the drain lumen. The method of Appendix 1, comprising at least one opening that is aligned with the interior of the proximal portion of the lumen.

Appendix 6. The method of Appendix 5, wherein at least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm.

Appendix 7. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support has a height along the central axis of the funnel-shaped support.

Appendix 8. The method of Appendix 7, wherein the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm.

Appendix 9. The method of Appendix 7, wherein the ratio of the height of at least one side wall of the funnel-shaped support to the second diameter ranges from about 1:25 to about 5: 1.

Appendix 10. At least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm, and the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm, and the funnel-shaped support. The method according to Appendix 5, wherein the second diameter of the above ranges from about 5 mm to about 25 mm.

Appendix 11. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support is continuous along the height of at least one side wall.

Appendix 12. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support comprises a solid wall.

Appendix 13. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support is formed from a balloon.

Appendix 14. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support is discontinuous along the height of at least one side wall.

Appendix 15. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support comprises at least one opening.

Appendix 16. The method of Appendix 1, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 50 mm ² .

Appendix 17. At least one side wall of the funnel-shaped support comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter having a second diameter. The method of Appendix 1, wherein the maximum distance between a portion of the side wall of the first coil and a portion of the adjacent sidewall of the second coil that is less than the diameter ranges from about 0 mm to about 10 mm.

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

Appendix 19. 17. The method of Appendix 17, wherein the diameter of the coil increases towards the distal end of the discharge lumen, resulting in a helical structure having a tapered or partially tapered configuration.

Appendix 20. At least one side wall of the funnel-shaped support comprises a mesh through which the mesh has multiple openings to allow fluid to flow into the drain lumen, the maximum area of the openings. 1 is the method according to Appendix 1, wherein the maximum size is about 100 mm ² .

Appendix 21. At least one side wall of the funnel-shaped support comprises an inwardly facing side and an outwardly facing side, which allows fluid to flow into the drainage lumen. The method according to Appendix 1, wherein the outward facing side is provided with at least one opening to make the opening essentially absent or absent.

Appendix 22. 21. The method of Appendix 21, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² .

Appendix 23. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and the fluid is discharged from the side that faces inward in the radial direction of the first coil. 17. The method of Appendix 17, comprising at least one opening to allow fluidization into the lumen.

Appendix 24. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and the fluid is discharged from the side that faces inward in the radial direction of the first coil. 17. The method of Appendix 17, comprising at least two openings to allow flow into the lumen.

Appendix 25. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and one or more sides of the first coil that face outward in the radial direction. 17. The method of Appendix 17, wherein the opening is essentially absent or absent.

Appendix 26. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and fluid is discharged from the side that faces inward in the radial direction of the first coil. Appendix 17, with at least one opening to allow flow into the lumen, with or without one or more openings on the radial outward facing side. The method described.

Appendix 27. The method of Appendix 15, wherein at least one opening on the side wall of the drain lumen allows fluid flow into the drain lumen by negative pressure.

Appendix 28. The method of Appendix 1, wherein the retaining portion of the drain lumen further comprises an open distal end to allow fluid to flow into the drain lumen.

Appendix 29. The funnel-shaped support comprises at least a third diameter, the third diameter being less than the second diameter, and the third diameter being the end of the distal portion of the drainage lumen from the second diameter. The method according to Appendix 1, which is close to.

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

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

Appendix 32. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support is convex.

Appendix 33. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support is concave.

Appendix 34. The method of Appendix 1, wherein the central axis of the funnel-shaped support is offset with respect to the central axis of the tube in the drain lumen.

Appendix 35. The method of Appendix 1, wherein the distal end of the retaining portion of the funnel-shaped support comprises a plurality of substantially rounded edges.

Appendix 36. The method of Appendix 1, wherein at least one side wall of the funnel-shaped support comprises a plurality of leaf-shaped longitudinal folds.

Appendix 37. 36. The method of Appendix 36, wherein the at least one phyllodes-shaped vertical fold comprises at least one vertical support member.

Appendix 38. 36. The method of Appendix 36, wherein the distal end of at least one phyllodes-shaped longitudinal fold comprises at least one support member.

Appendix 39. At least one side wall of the funnel-shaped support comprises an inner side wall and an outer side wall, through which the inner side wall is at least one to allow fluid flow into the interior of the proximal portion of the drainage lumen. The method according to Appendix 1, comprising one opening.

Appendix 40. The method of Appendix 1, wherein the funnel-shaped support comprises a porous material located inside the side wall.

Appendix 41. The method of Appendix 1, wherein the funnel-shaped support comprises a porous liner positioned adjacent to the interior of the side wall.

Appendix 42. The method of Appendix 1, wherein the catheter is transitionable between a contraction configuration for insertion into the patient's ureter and a deployment configuration for deployment within the ureter.

Appendix 43. The discharge cavity is at least partially one or more of copper, silver, gold, nickel-titanium alloys, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone. The method according to Appendix 1, which is formed from a material.

Appendix 44. A ureteral catheter that is a drainage lumen with a distal portion and a proximal portion configured to be located in the patient's kidney, in the renal pelvis, and / or in the ureter adjacent to the renal pelvis. The distal portion comprises at least one side wall, the funnel-shaped support, the retention portion, the funnel-shaped support having a first diameter and a second diameter, the first diameter being , Less than the second diameter, the second diameter is closer to the end of the distal portion of the ureter than the first diameter, and the proximal portion of the ureter is essentially free of openings A ureteral catheter with or without a drainage lumen.

Appendix 45. 44. The ureteral catheter according to Appendix 44, wherein the flow of urine from the ureter and / or kidney is not impeded by obstruction of the ureter and / or kidney by the catheter.

Appendix 46. The ureteral catheter according to Appendix 44, wherein the funnel-shaped support has a substantially conical shape.

Appendix 47. The ureteral catheter according to Appendix 44, wherein the funnel-shaped support has a substantially hemispherical shape.

Appendix 48. The funnel-shaped support comprises a base portion adjacent to the distal portion of the drainage lumen, which drains to allow fluid to flow inside the proximal portion of the drainage lumen. 44. The ureteral catheter according to Appendix 44, comprising at least one opening that is aligned with the interior of the proximal portion of the lumen.

Appendix 49. The ureteral catheter according to Appendix 48, wherein at least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm.

Appendix 50. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support has a height along the central axis of the funnel-shaped support.

Appendix 51. The ureteral catheter according to Appendix 50, wherein the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm.

Appendix 52. The ureteral catheter according to Appendix 50, wherein the ratio of the height of at least one side wall of the funnel-shaped support to the second diameter ranges from about 1:25 to about 5: 1.

Appendix 53. At least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm, and the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm, and the funnel-shaped support. The ureteral catheter according to Appendix 48, wherein the second diameter ranges from about 5 mm to about 25 mm.

Appendix 54. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support is continuous along the height of at least one side wall.

Appendix 55. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support comprises a solid wall.

Appendix 56. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support is formed from a balloon.

Appendix 57. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support is discontinuous along the height of at least one side wall.

Appendix 58. 44. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support comprises at least one opening.

Appendix 59. The ureteral catheter according to Appendix 44, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 50 mm ² .

Appendix 60. At least one side wall of the funnel-shaped support comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter having a second diameter. The urinary tract, according to Appendix 44, which is less than the diameter and the maximum distance between a portion of the side wall of the first coil and a portion of the adjacent sidewall of the second coil ranges from about 0 mm to about 10 mm. catheter.

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

Appendix 62. The ureteral catheter according to Appendix 60, wherein the diameter of the coil increases towards the distal end of the drainage lumen, resulting in a helical structure having a tapered or partially tapered configuration.

Appendix 63. At least one side wall of the funnel-shaped support comprises a mesh through which the mesh has multiple openings to allow fluid to flow into the drainage lumen, the maximum area of the openings. Is a ureteral catheter according to Appendix 44, which has a maximum size of about 100 mm ² .

Appendix 64. At least one side wall of the funnel-shaped support comprises an inwardly facing side and an outwardly facing side, which allows fluid to flow into the drainage lumen. 44. The ureteral catheter according to Appendix 44, comprising at least one opening for the outward facing side, which has essentially no or no opening.

Appendix 65. The ureteral catheter according to Appendix 64, wherein at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² .

Appendix 66. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and the fluid is discharged from the side that faces inward in the radial direction of the first coil. 60. The ureteral catheter according to Appendix 60, comprising at least one opening to allow fluidization into the lumen.

Appendix 67. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and the fluid is discharged from the side that faces inward in the radial direction of the first coil. 60. The ureteral catheter according to Appendix 60, comprising at least two openings to allow fluidization into the lumen.

Appendix 68. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and one or more sides of the first coil that face outward in the radial direction. The ureteral catheter according to Appendix 60, wherein the opening is essentially absent or absent.

Appendix 69. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and fluid is discharged from the side that faces inward in the radial direction of the first coil. Appendix 60, which comprises at least one opening to allow flow into the cavity, with or without one or more openings on the radial outward facing side. The described ureteral catheter.

Appendix 70. The ureteral catheter according to Appendix 58, wherein at least one opening on the side wall of the drainage lumen allows fluid flow into the drainage lumen by negative pressure.

Appendix 71. The ureteral catheter according to Appendix 44, wherein the retaining portion of the drainage lumen further comprises an open distal end to allow fluid to flow into the drainage lumen.

Appendix 72. The funnel-shaped support has a third diameter, the third diameter being less than the second diameter, and the third diameter at the end of the distal portion of the drainage lumen from the second diameter. Closely, the ureteral catheter according to Appendix 4.

Appendix 73. The ureteral catheter according to Appendix 58, wherein the one or more openings are circular.

Appendix 74. The ureteral catheter according to Appendix 58, wherein the one or more openings are non-circular.

Appendix 75. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support is convex.

Appendix 76. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support is concave.

Appendix 77. The ureteral catheter according to Appendix 44, wherein the central axis of the funnel-shaped support is offset with respect to the central axis of the tube of the drain lumen.

Appendix 78. The ureteral catheter according to Appendix 44, wherein the distal end of the retention portion of the funnel-shaped support has a plurality of substantially rounded edges.

Appendix 79. The ureteral catheter according to Appendix 44, wherein at least one side wall of the funnel-shaped support comprises a plurality of phyllodes-shaped longitudinal folds.

Appendix 80. The ureteral catheter according to Appendix 79, wherein the at least one phyllodes-shaped longitudinal fold comprises at least one longitudinal support member.

Appendix 81. The ureteral catheter according to Appendix 79, wherein the distal end of at least one phyllodes-shaped longitudinal fold comprises at least one support member.

Appendix 82. At least one side wall of the funnel-shaped support comprises an inner side wall and an outer side wall, through which the inner side wall is at least one to allow fluid flow into the interior of the proximal portion of the drainage lumen. 44. The ureteral catheter according to Appendix 44, comprising one opening.

Appendix 83. The ureteral catheter according to Appendix 44, wherein the funnel-shaped support comprises a porous material located inside the side wall.

Appendix 84. The ureteral catheter according to Appendix 44, wherein the funnel-shaped support comprises a porous liner positioned adjacent to the inside of the side wall.

Appendix 85. The ureteral catheter according to Appendix 44, wherein the catheter is transitionable between a contraction configuration for insertion into the patient's ureter and a deployment configuration for deployment within the ureter.

Appendix 86. The discharge cavity is at least partially one or more of copper, silver, gold, nickel-titanium alloys, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone. 44. A urinary tract catheter formed from one of the above.

Appendix 87. A system for inducing negative pressure within a portion of a patient's urinary tract, with a distal portion configured to be located in the patient's kidney, in the renal funnel, and / or in the ureter adjacent to the renal funnel. At least one ureteral catheter with a proximal portion, with a drainage lumen, the distal portion with at least one side wall, with a funnel-shaped support, with a retaining part, funnel-shaped support The body comprises a first diameter and a second diameter, the first diameter being less than the second diameter, the second diameter being the distal portion of the drainage lumen from the first diameter. Close to the end of the ureter, the proximal portion of the ureter is configured to extend to a deployment position where the diameter of the retention portion is greater than the diameter of the ureter portion, with essentially no or no openings. The funnel-shaped support is provided with at least one ureteral catheter and a proximal portion of the drainage lumen, comprising at least one drainage opening to allow fluid to flow into the drainage lumen. A system comprising a pump that communicates with fluid and is configured to induce negative pressure within a portion of the patient's ureter and to draw fluid through the drainage lumen of a ureteral catheter.

Appendix 88. 8. The system of Appendix 87, wherein urine flow from the ureter and / or kidney is not impeded by obstruction of the ureter and / or kidney by a catheter.

Appendix 89. The system according to Appendix 87, wherein the funnel-shaped support has a substantially conical shape.

Appendix 90. The system according to Appendix 87, wherein the funnel-shaped support has a substantially hemispherical shape.

Appendix 91. The funnel-shaped support comprises a base portion adjacent to the distal portion of the drain lumen, which drains to allow fluid to flow inside the proximal portion of the drain lumen. 87. The system of Appendix 87, comprising at least one opening that is aligned with the interior of the proximal portion of the lumen.

Appendix 92. The system of Appendix 91, wherein at least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm.

Appendix 93. 8. The system of Appendix 87, wherein at least one side wall of the funnel-shaped support has a height along the central axis of the funnel-shaped support.

Appendix 94. The system according to Appendix 93, wherein the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm.

Appendix 95. The system according to Appendix 93, wherein the ratio of the height of at least one side wall of the funnel-shaped support to the second diameter ranges from about 1:25 to about 5: 1.

Appendix 96. At least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm, and the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm, and the funnel-shaped support. The system according to Appendix 91, wherein the second diameter ranges from about 5 mm to about 25 mm.

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

Appendix 98. The system of Appendix 87, wherein at least one side wall of the funnel-shaped support comprises a solid wall.

Appendix 99. 87. The system of Appendix 87, wherein at least one side wall of the funnel-shaped support is formed from a balloon.

Appendix 100. The system of Appendix 87, wherein at least one side wall of the funnel-shaped support is discontinuous along the height of at least one side wall.

Appendix 101. 87. The system of Appendix 87, wherein at least one side wall of the funnel-shaped support comprises at least one opening.

Appendix 102. The system according to Appendix 87, wherein at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² .

Appendix 103. At least one side wall of the funnel-shaped support comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter having a second diameter. The system according to Appendix 87, wherein the maximum distance between a portion of the side wall of the first coil and a portion of the adjacent sidewall of the second coil that is less than the diameter ranges from about 0 mm to about 10 mm.

Appendix 104. The system according to Appendix 103, wherein the first diameter of the first coil ranges from about 1 mm to about 10 mm and the second diameter of the second coil ranges from about 5 mm to about 25 mm.

Appendix 105. The system according to Appendix 103, wherein the diameter of the coil increases towards the distal end of the discharge lumen, resulting in a helical structure having a tapered or partially tapered configuration.

Appendix 106. At least one side wall of the funnel-shaped support comprises a mesh through which the mesh has multiple openings to allow fluid to flow into the drain lumen, the maximum area of the openings. 87 is the system according to Appendix 87, wherein the maximum size is about 100 mm ² .

Appendix 107. At least one side wall of the funnel-shaped support comprises an inwardly facing side and an outwardly facing side, which allows fluid to flow into the drainage lumen. 87. The system of Appendix 87, comprising at least one opening for the outward facing side, which has essentially no or no opening.

Appendix 108. The system according to Appendix 107, wherein at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² .

Appendix 109. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and fluid is discharged from the side that faces inward in the radial direction of the first coil. The system according to Appendix 103, comprising at least one opening to allow flow into the lumen.

Appendix 110. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and fluid is discharged from the side that faces inward in the radial direction of the first coil. 10. The system of Appendix 103, comprising at least two openings to allow flow into the cavity.

Appendix 111. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and one or more sides of the first coil that face outward in the radial direction. The system according to Appendix 103, wherein the opening is essentially absent or absent.

Appendix 112. The first coil has a side wall that includes a side that faces inward in the radial direction and a side that faces outward in the radial direction, and fluid is discharged from the side that faces inward in the radial direction of the first coil. Appendix 103, provided with at least one opening to allow flow into the lumen, with or without one or more openings on the radial outward facing side. Described system.

Appendix 113. The system of Appendix 101, wherein at least one opening on the side wall of the drain lumen allows fluid flow into the drain lumen by negative pressure.

Appendix 114. The system of Appendix 87, wherein the retaining portion of the drain lumen further comprises an open distal end to allow fluid to flow into the drain lumen.

Appendix 115. The funnel-shaped support comprises a third diameter, the third diameter being less than the second diameter, and the third diameter being at the end of the distal portion of the drainage lumen from the second diameter. Closely, the system according to Appendix 87.

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

Addendum 117.1 The system of Addendum 101, wherein the one or more openings are non-circular.

Appendix 118. The system according to Appendix 87, wherein at least one side wall of the funnel-shaped support is convex.

Appendix 119. The system according to Appendix 87, wherein at least one side wall of the funnel-shaped support is concave.

Appendix 120. 87. The system of Appendix 87, wherein the central axis of the funnel-shaped support is offset with respect to the central axis of the tube in the discharge lumen.

Appendix 121. 8. The system of Appendix 87, wherein the distal end of the retention portion of the funnel-shaped support comprises a plurality of substantially rounded edges.

Appendix 122. The system of Appendix 87, wherein at least one side wall of the funnel-shaped support comprises a plurality of phyllodes-shaped longitudinal folds.

Appendix 123. The system of Appendix 122, wherein the at least one phyllodes-shaped vertical fold comprises at least one vertical support member.

Appendix 124. The system of Appendix 122, wherein the distal end of at least one phyllodes-shaped longitudinal fold comprises at least one support member.

Appendix 125. At least one side wall of the funnel-shaped support comprises an inner side wall and an outer side wall, through which the inner side wall is at least one to allow fluid flow into the interior of the proximal portion of the drainage lumen. 87. The system of Appendix 87, comprising one opening.

Appendix 126. 28. The system of Appendix 87, wherein the funnel-shaped support comprises a porous material, located inside the side wall.

Appendix 127. The system of Appendix 87, wherein the funnel-shaped support comprises a porous liner, located adjacent to the interior of the side wall.

Appendix 128. The system of Appendix 87, wherein the catheter is transitionable between a contraction configuration for insertion into the patient's ureter and a deployment configuration for deployment within the ureter.

Appendix 129. The discharge cavity is at least partially one or more of copper, silver, gold, nickel-titanium alloys, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone. 87. The system of Appendix 87, which is formed of

Not only these and other features and properties of the present disclosure, but also the combination of operating methods and functions of the relevant elements of the structure and the economics of parts and manufacturing, all of which form part of this specification and similar references. The numbers will be more apparent from the discussion of the following description and accompanying appendices, with reference to the accompanying drawings, which specify the corresponding parts in the various figures. However, it should be clearly understood that the drawings are for illustration and illustration purposes only and are not intended as a limited definition of the invention.

Further features and other examples and advantages will also become apparent from the following detailed description discussed with reference to the drawings.

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

FIG. 2A is a perspective view of an exemplary ureteral catheter according to an embodiment of the present disclosure.

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

FIG. 3A is a schematic view of an example of a retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 3B is a schematic representation of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 3C is a schematic representation of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 3D is a schematic representation of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 3E is a schematic representation of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 4A is a schematic representation of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 4B is a schematic cross-sectional view of a portion of the retention portion of FIG. 4A obtained along line BB of FIG. 4A.

FIG. 5A is a schematic representation of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 5B is a schematic view of a part of a cross-sectional view of the retention portion of FIG. 5A obtained along line BB of FIG. 5A.

FIG. 6 is a schematic view of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 7 is a schematic cross-sectional view of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 8 is a schematic view of another embodiment of the retention portion for a ureteral catheter according to an embodiment of the present invention.

FIG. 9A is a schematic representation of another embodiment of the urine collection assembly according to an embodiment of the present invention.

FIG. 9B is a partial schematic taken along cross sections 9B-9B of the bladder anchor portion of the assembly of FIG. 9A.

FIG. 10A is a schematic representation of another embodiment of the urine collection assembly according to an embodiment of the present invention.

FIG. 10B is a schematic view obtained along cross sections 10B-10B of the bladder anchor portion of the assembly of FIG. 10A.

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

FIG. 11B is a schematic view obtained along cross sections 11B-11B of the bladder anchor portion of the assembly of FIG. 11A.

FIG. 12A is a schematic representation of another bladder anchor portion of the urine collection assembly according to an embodiment of the present disclosure.

FIG. 12B is a schematic cross-sectional view of the bladder catheter of the urine collection assembly obtained along line CC of FIG. 12A.

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

FIG. 13 is a schematic representation of another embodiment of the bladder anchor portion of the urine collection assembly according to the embodiment of the present disclosure.

FIG. 14 is a schematic representation of another embodiment of the bladder anchor portion of the urine collection assembly according to the embodiment of the present disclosure.

FIG. 15 is a schematic representation of another embodiment of the bladder anchor portion of a urine collection assembly configured to be deployed within the patient's bladder and urethra according to an embodiment of the present invention.

FIG. 16 is a schematic representation of another embodiment of the bladder anchor portion of the urine collection assembly according to an embodiment of the present invention.

FIG. 17A is an exploded perspective view of a connector for a urine collection assembly according to an embodiment of the present disclosure.

FIG. 17B is a cross-sectional view of a part of the connector of FIG. 17A.

FIG. 17C is a schematic diagram of a connector for a urine collection assembly according to an embodiment of the present disclosure.

FIG. 18A is a flow chart illustrating the process for insertion and deployment of a ureteral catheter or urine collection assembly according to an embodiment of the present invention.

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

FIG. 19 is a schematic diagram of a system for inducing negative pressure into a patient's urinary tract according to an embodiment of the present invention.

FIG. 20A is a plan view of a pump for use with the system of FIG. 19 according to an embodiment of the present invention.

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

FIG. 21 is a schematic diagram of an experimental setup for evaluating negative pressure therapy in a pig model.

FIG. 22 is a graph of creatinine clearance rates for tests performed using the experimental settings shown in FIG.

FIG. 23A is a low magnification photomicrograph of kidney tissue from a stagnant kidney treated with negative pressure therapy.

FIG. 23B is a high magnification photomicrograph of the kidney tissue shown in FIG. 23A.

FIG. 23C is a low magnification photomicrograph of kidney tissue from a depressed and untreated (eg, control) kidney.

FIG. 23D is a high magnification photomicrograph of the kidney tissue shown in FIG. 23C.

FIG. 24 is a flow chart illustrating the process for reducing creatinine and / or protein levels in a patient according to an example of the present disclosure.

FIG. 25 is a flow chart illustrating a process for treating a patient receiving a resuscitation infusion according to an embodiment of the present disclosure.

FIG. 26 is a graph of serum albumin relative to baseline for tests performed in pigs using the experimental methods described herein.

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

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

FIG. 29 is a front view of another embodiment of the ureteral catheter according to the embodiment of the present disclosure.

FIG. 30A is a perspective view of the retention portion of the ureteral catheter of FIG. 29 enclosed by a circular 30A according to an embodiment of the present disclosure.

FIG. 30B is a front view of the retention portion of FIG. 30A according to the embodiment of the present disclosure.

FIG. 30C is a rear view of the retention portion of FIG. 30A according to the embodiment of the present disclosure.

FIG. 30D is a top view of the retention portion of FIG. 30A according to the embodiment of the present disclosure.

FIG. 30E is a cross-sectional view of a retention portion of FIG. 30A obtained along lines 30E-30E according to an embodiment of the present disclosure.

FIG. 31 is a schematic view of a retention portion of a ureteral catheter in a restrained or linear position according to an embodiment of the present disclosure.

FIG. 32 is a schematic representation of another embodiment of a retention portion of a ureteral catheter in a restrained or linear position according to an embodiment of the present disclosure.

FIG. 33 is a schematic representation of another embodiment of the retention portion of the ureteral catheter in a restrained or linear position according to the embodiment of the present disclosure.

FIG. 34 is a schematic representation of another embodiment of the retention portion of the ureteral catheter in a restrained or linear position according to the embodiment of the present disclosure.

FIG. 35A is a graph showing the percentage of fluid flow through the opening of an exemplary ureteral catheter as a function of position according to an embodiment of the present disclosure.

FIG. 35B is a graph showing the percentage of fluid flow through the opening of another exemplary ureteral catheter as a function of position, according to an embodiment of the present disclosure.

FIG. 35C is a graph showing the percentage of fluid flow through the opening of another exemplary ureteral catheter as a function of position, according to an embodiment of the present disclosure.

FIG. 36 is a perspective view of a tube assembly and a y-connector for connecting a ureteral catheter to a fluid pump according to an embodiment of the present disclosure.

FIG. 37 is a perspective view of a ureteral catheter connected to the y-connector of FIG. 36 according to an embodiment of the present disclosure.

FIG. 38 is a schematic view of a retention portion of a ureteral catheter showing a station for calculating fluid flow coefficients for mass transfer balance evaluation according to an embodiment of the present disclosure.

FIG. 39 is a schematic representation of the renal unit and surrounding vascular system showing the location of the capillary bed and tubular tubules.

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

FIG. 41A is a side elevation view of the retention portion of the ureteral catheter according to the embodiment of the present disclosure.

41B is a cross-sectional view of the retention portion of the ureteral catheter of FIG. 41A obtained along line BB of FIG. 41A.

41C is an upper plan view of the retention portion of the ureteral catheter of FIG. 41A obtained along line CC of FIG. 41A.

FIG. 42 is a side elevation view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 43 is a side elevation view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 44 is a side elevation view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 45A is a perspective view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

45B is an upper plan view of the retention portion of the ureteral catheter of FIG. 45A obtained along line BB of FIG. 45A.

FIG. 46A is a perspective view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 46B is an upper plan view of the retention portion of the ureteral catheter of FIG. 46A obtained along line BB of FIG. 46A.

FIG. 47 is a perspective view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 48 is a side elevation view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 49 is a side elevation view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 50 is a cross-sectional side view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 51A is a perspective view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 51B is an upper plan view of the retention portion of the ureteral catheter of FIG. 51A.

FIG. 52A is a perspective view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

52B is an upper plan view of the retention portion of the ureteral catheter of FIG. 52A.

FIG. 53A is a perspective view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 53B is an upper plan view of the retention portion of the ureteral catheter of FIG. 53A.

FIG. 54 is a perspective view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 54B is an upper plan view of the retention portion of the ureteral catheter of FIG. 54A.

FIG. 55 is a cross-sectional side elevation view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 56 is a cross-sectional side elevation view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 57A is a perspective view of a retention portion of another ureteral catheter according to an embodiment of the present disclosure.

FIG. 57B is a cross-sectional side elevation view of the retention portion of the ureteral catheter of FIG. 57A obtained along line BB of FIG. 57A.

FIG. 58 is a side elevation view showing a cut sectional view of the sheath surrounding the ureteral catheter in a contracted configuration for insertion into the ureter of a patient according to an embodiment of the present disclosure.

As used herein, the singular forms of "a," "an," and "the" also include multiple references unless expressly indicated otherwise by context.

As used herein, the terms "right", "left", "top", and variants thereof shall relate to the present invention as oriented in the drawings. The term "proximal" refers to the portion of the catheter device that is operated or contacted by the user and / or the portion of the indwelling catheter closest to the urethral access site. The term "distal" refers to a portion of a device that is inserted at the opposite end of a catheter device that is configured to be inserted into a patient and / or at the most distal end of the patient's urethra. However, it should be understood that the present invention can take a variety of alternative orientations and therefore such terms are not considered limiting. It should also be understood that the present invention may take various alternative variants and step sequences unless the opposite is explicitly specified. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are examples. Therefore, the specific dimensions and other physical properties associated with the embodiments disclosed herein are not considered limiting.

For the purposes of this specification, unless otherwise indicated, all numbers representing quantities such as components, reaction conditions, dimensions, physical properties, etc. used in the specification and claims are in all cases the term ". It should be understood as being modified by "about". Unless the opposite is indicated, the numerical parameters set forth in the following specification and the accompanying claims are approximations that may vary depending on the desired properties sought to be obtained by the present invention.

The numerical ranges and parameters that describe the broad scope of the invention are approximate values, but the numerical values described in the specific examples are reported as precisely as possible. However, any numerical value essentially contains some error that inevitably arises from the standard deviation found in that individual test measurement.

It should also be understood that any numerical range listed herein is intended to include all subranges contained therein. For example, the range "1-10" starts from any range between them, including 1 enumerated minimum and 10 enumerated maximums, i.e. a minimum of 1 or more, and 10 or less. It is intended to include all subranges ending at the maximum value and all subranges in between, such as 1-6.3, or 5.5-10, or 2.7-6.1.

As used herein, the terms "communicate" and "communicate" refer to the reception or transfer of one or more signals, messages, commands, or other types of data. When one unit or component communicates with another unit or component, one unit or component receives data directly or indirectly from another unit or component and / or data there. Means that it is possible to transmit. This can refer to a direct or indirect connection, which in nature can be wired and / or wireless. In addition, the two units or components are mutually even if the data transmitted is modified, processed, routed, and equivalent between the first and second units or components. Can communicate with. For example, the first unit can communicate with the second unit even if the first unit passively receives the data and does not actively transmit the data to the second unit. As another embodiment, the first unit may communicate with the second unit even if the intermediate unit processes data from one unit and transmits the processed data to the second unit. it can. It should be understood that many other sequences are also possible.

Fluid retention and venous stagnation are major problems in the progression of progressive renal disease. Excess sodium intake associated with a relative decrease in excretion leads to isotonic volume swelling and complications of secondary compartment syndrome. In some examples, the invention generally relates to devices and methods for facilitating the excretion of urine or waste from a patient's bladder, ureter, and / or kidney. In some examples, the invention generally relates to devices and methods for inducing negative pressure in a patient's bladder, ureter, and / or kidney. Although not intended to be constrained by any theory, applying negative pressure to the bladder, ureter, and / or kidney, in some situations, is a sodium and water medullary renal unit tubular recanalization. It is believed that absorption can be compensated. Compensation for sodium and water reabsorption can increase urine production, reduce total body sodium, and improve red blood cell production. Target removal of excess sodium makes it possible to maintain fluid loss, as intramedullary pressure is driven by sodium, and thus volume overload. Removal of fluid volume restores medulla. Normal urine production is 1.48 to 1.96 L / day (or 1 to 1.4 ml / min).

Fluid retention and venous stagnation are also major problems in the progression of prerenal acute kidney injury (AKI). Specifically, AKI may be associated with perfusion through the kidney or loss of blood flow. Therefore, in some embodiments, the present invention promotes improved renal hemodynamics and increases urination for the purpose of alleviating or reducing venous stagnation. In addition, treatment and / or inhibition of AKI is expected to have a positive effect on the development of other medical conditions and / or reduce it, with, for example, NYHA classification III and / or classification IV heart failure. This includes reducing or preventing deterioration of renal function in patients. Different levels of heart failure are classified by the Criteria Committee of the New York Heart Association, (1994), Nomenclature and Criteria for Diagnosis of Boston, Boston, Boston pp. It is described in 253-256 (the present disclosure is incorporated herein by reference in its entirety). Reducing or blocking episodes of AKI and / or chronic perfusion reduction can also be treatment for stage 4 and / or stage 5 chronic kidney disease. The progression of chronic kidney disease is described in the National Kidney Foundation, K / DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evolution, Classication and Tratification. Am. J. Kidney Dis. 39: S1-S266,2002 (Suppl.1), the disclosure of which is incorporated herein by reference in its entirety.

With reference to FIGS. 1, 27, and 40, the urethra comprises the patient's right kidney 2 and left kidney 4. As mentioned above, kidneys 2 and 4 are involved in hemofiltration and clearing of waste compounds from the body through urine. The urine produced by the right kidney 2 and the left kidney 4 is drained into the patient's bladder 10 through the renal tubules, i.e. the right ureter 6 and the left ureter 8. For example, urine can be conducted through ureters 6 and 8 by peristalsis and gravity of the ureteral wall. The ureters 6 and 8 enter the bladder 10 through the ureteral ostium or opening 16. The bladder 10 is a flexible and substantially hollow structure adapted to collect urine until it is excreted from the body. The bladder 10 is capable of transitioning from an empty position (indicated by reference line E) to a full position (indicated by reference line F). Normally, when the bladder 10 reaches a substantially full state, urine can be drained from the bladder 10 into the urethra 12 through the urethral sphincter or opening 18 located in the lower portion of the bladder 10. The contraction of the bladder 10 may respond to stress and pressure applied on the triangular region 14 of the bladder 10, which is a triangular region extending between the ureteral opening 16 and the urethral opening 18. The triangular region 14 is sensitive to stress and pressure so that the pressure on the triangular region 14 increases as the bladder 10 begins to fill. Above the threshold pressure on the triangular region 14, the bladder 10 contracts and begins to release the collected urine through the urethra 12.

In some embodiments, a method for facilitating urination from the kidney, (a) a catheter of the invention as disclosed herein, adjacent to the patient's kidney, renal pelvis, or renal pelvis. A method comprising inserting into at least one of the urinary tracts and (b) applying negative pressure to the proximal portion of the drainage lumen of the catheter over a time cycle to facilitate urination from the kidney. Is provided. Specific properties of the exemplary ureteral catheters of the invention are described in detail herein.

An exemplary ureteral catheter:
With reference to FIG. 40, two exemplary ureteral catheters 5000, 5001 located in the patient's urethra are shown. The ureteral catheters 5000 and 5001 drain urine and other fluids from at least one of the patient's kidneys 2, 4, renal pelvis 20, 21, or ureters 6, 8 adjacent to the renal pelvis 20, 21. It includes ureters 5002 and 5003. The drainage cavities 5002, 5003 are configured to be located within the ureters 6, 8 adjacent to the patient's kidneys 2, 4, renal pelvis 20, 21, and / or renal pelvis 20, 21, distal portion 5004, It comprises 5005 and proximal portions 5006, 5007 through which fluid 5008 is drained out of the patient's bladder 10 or body.

In some embodiments, the distal portions 5004, 5005 comprises open distal ends 5010, 5011 for drawing fluid into the drain lumen 5002, 5003. Distal portions 5004, 5005 of ureteral catheters 5000, 5001 further provide retention lumens or retention portions 5012, 5013 to maintain distal portions 5004, 5005 of tubes 5002, 5003 in the ureter and / or kidney. Be prepared. The retention portions 5012, 5013 are flexible and / or flexible and can allow the positioning of the retention portions 5012, 5013 within the ureter, renal pelvis, and / or kidney. For example, the retention portions 5012, 5013 are preferably flexible enough to absorb the forces exerted on the catheters 5000, 5001 and prevent such forces from being transmitted to the ureter. Further, if the retention portions 5012, 5013 are pulled towards the patient's bladder 10 in the proximal direction P (shown in FIG. 40), the retention portions 5012, 5013 may be pulled out through the ureters 6, 8. Can be flexible enough to begin unwinding, straightening, or crushing.

The retention portions 5012, 5013 can be formed from the same material as the discharge lumen and can be integrated with the discharge lumens 5002, 5003, or the retention portions 5012, 5013 can be integrated with the discharge lumens 5002, 5003. It is made of different materials and can be connected there. The discharge cavities 5002, 5003, at least in part, are copper, silver, gold, nickel-titanium alloys, stainless steel, titanium, and / or polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and /. Alternatively, it can be formed from one or more of polymers such as silicone. Retaining portions 5012, 5013 include the aforementioned materials and polyurethane, flexible polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, silicone, polyglycolide or poly (glycolic acid) (PGA), polylactic acid (PLA), It can be formed from any of the polymers such as poly (lactic acid-co-glycolic acid), polyhydroxyalkanoic acid, polycaprolactone and / or poly (propylene fumarate).

Generally, the retaining portion comprises a funnel-shaped support. The funnel-shaped support comprises at least one side wall. At least one side wall of the funnel-shaped support comprises a first diameter and a second diameter, the first diameter being less than the second diameter. The second diameter of the funnel-shaped support is closer to the end of the distal portion of the drainage lumen than the first diameter.

The proximal part of the drainage lumen or the drainage tube has essentially no or no opening. Although not intended to be constrained by any theory, when negative pressure is applied to the proximal end of the proximal portion of the ureter, the outlet or opening in the proximal portion of the ureter. Such openings are not desirable because they can reduce the negative pressure in the distal portion of the ureteral catheter, thereby reducing the withdrawal or flow of fluid or urine from the kidney and the renal pelvis of the kidney. it is conceivable that. It is desirable that fluid flow from the ureter and / or kidney is not impeded by obstruction of the ureter and / or kidney by a catheter. Also, although not intended to be constrained by any theory, when negative pressure is applied to the proximal end of the proximal portion of the drain lumen, the ureteral tissue becomes the proximal portion of the drain lumen. It can be drawn into or into the opening along the opening, which is believed to be able to inflame the tissue.

Some examples of ureteral catheters with retaining portions constituting a funnel-shaped support according to the present invention are shown in FIGS. 1-7, 27-34, and 40-57B. In FIGS. 1-3E and 27-34, the funnel-shaped support is formed by a coil of tubes. 4A-7 and 40-57B show other examples of funnel-shaped supports. Each of these funnel-shaped supports according to the invention will be discussed in detail below.

With reference to FIGS. 41A-C, in some examples, the distal portion 5004 of the ureteral catheter is shown, generally as 5000. The distal portion 5004 comprises a retention portion 5012 that constitutes the funnel-shaped support 5014. The funnel-shaped support 5014 comprises at least one side wall 5016. At least one side wall 5016 of the funnel-shaped support 5014 comprises a first (outer) diameter D4 and a second (outer) diameter D5, the first outer diameter D4 being less than the second outer diameter D5. Is. The second outer diameter D5 of the funnel-shaped support 5014 is closer to the distal end 5010 of the distal portion 5004 of the discharge lumen 5002 than the first outer diameter D4. In some embodiments, the first outer diameter D4 can range from about 0.33 mm to 4 mm (about 1 Fr to about 12 Fr (French catheter scale)) or about 2.0 ± 0.1 mm. In some embodiments, the second outer diameter D5 is larger than the first outer diameter D4 and can range from about 1 mm to about 60 mm, or about 10 mm to 30 mm, or about 18 mm ± 2 mm.

In some embodiments, the at least one side wall 5016 of the funnel-shaped support 5014 can further include a third diameter D7 (shown in FIG. 41B), the third diameter D7 being the second outer. The diameter is less than D5. The third diameter D7 of the funnel-shaped support 5014 is closer to the distal end 5010 of the distal portion 5004 of the discharge lumen 5002 than the second diameter D5. The third diameter D7 is discussed in more detail below with respect to the edges. In some embodiments, the third diameter D7 can range from about 0.99 mm to about 59 mm or from about 5 mm to about 25 mm.

At least one side wall 5016 of the funnel-shaped support 5014 comprises a first (inner) diameter D6. The first inner diameter D6 is closer to the proximal end 5017 of the funnel-shaped support 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 can range from about 0.05 mm to 3.9 mm or about 1.25 ± 0.75 mm.

In some embodiments, the total height H5 of the side wall 5016 along the central axis 5018 of the retention portion 5012 can range from about 1 mm to about 25 mm. In some embodiments, the height H5 of the sidewalls can vary at different parts of the sidewalls, for example, if the sidewalls have wavy or rounded edges as shown in FIG. 47. In some examples, the wavy portion can be about 0.01 mm to about 5 mm or larger, if desired.

In some embodiments, as shown in FIGS. 4A-7, 41A-B, 43, 44, 45A, 46A, 47, 48, 49, 50, 51, 52, 53, 54, and 55-57B, The funnel-shaped support 5014 can have a substantially conical shape. In some embodiments, the angle 5020 between the outer wall 5022 near the proximal end 5017 of the funnel-shaped support 5014 and the drain lumen 5002 adjacent to the base portion 5024 of the funnel-shaped support 5014 is about 100 degrees. It can range from ~ about 180 degrees, or about 100 degrees to about 160 degrees, or about 120 degrees to about 130 degrees. The angle 5020 may vary at different positions around the circumference of the funnel-shaped support 5014, as shown in FIG. 45A, where the angle 5020 ranges from about 140 degrees to about 180 degrees.

In some embodiments, the edge or margin 5026 of the distal end 5010 of at least one side wall 5016 can be rounded, square, or any desired shape. The shapes defined by the edge 5026 are, for example, circular (as shown in FIGS. 41C and 46B), oval (as shown in FIG. 45B), and leaf-shaped (as shown in FIGS. 51B, 52B, 53B). , Square, rectangular, or any desired shape.

Here, with reference to FIGS. 51A-53B, a funnel-shaped support 5300 is shown, at least one side wall 5302 comprising a plurality of leaf-shaped longitudinal folds 5304 along the length L7 of the side wall 5302. The number of folds 5304 can be 2 to about 20 or about 6 as shown. In this example, the folds 5304 are formed from one or more flexible materials such as silicone, polymer, solid material, fabric, or permeable mesh and can provide the desired phyllodes shape. The folds 5304 can have a substantially rounded shape, as shown in cross-sectional view 51B. The depth D10 of each fold 5304 at the distal end 5306 of the funnel-shaped support 5300 can be the same or variable and can range from about 0.5 mm to about 5 mm.

Here, with reference to FIGS. 52A and 52B, one or more folds 5304 may include at least one longitudinal support member 5308. The vertical support member 5308 can straddle the total length L7 or a part of the length L7 of the funnel-shaped support 5300. The longitudinal support member 5308 can be formed from a temperature sensitive shape memory material, such as a flexible but partially rigid material such as nitinol. The thickness of the longitudinal support member 5308 can range from about 0.01 mm to about 1 mm, if desired. In some embodiments, the nitinol frame can be coated with a suitable waterproof material such as silicone to form a tapered portion or funnel. In that case, the fluid is allowed to follow the inner surface 5310 of the funnel-shaped support 5300 and flow into the discharge lumen 5312. In another embodiment, the folds 5304 are formed from various rigid or partially rigid sheets or materials that are bent or molded to form funnel-shaped retaining portions.

With reference to FIGS. 53A and 53B, the distal end or edge 5400 of the fold 5402 may include at least one edge support member 5404. The edge support member 5404 can span the entire circumference 5406 or one or more portions of the circumference 5406 of the distal edge 5400 of the funnel-shaped support 5408. The edge support member 5404 can be formed from a temperature sensitive shape memory material, such as a flexible but partially rigid material such as nitinol. The thickness of the edge support member 5404 can range from about 0.01 mm to about 1 mm, if desired.

In some embodiments as shown in FIGS. 41A-C, the distal end 5010 of the drain lumen 5002 (or funnel-shaped support 5014) is, for example, a funnel-shaped support 5014 of about 0.01 mm to about 1 mm. It has an inwardly oriented margin 5026 oriented towards the center of the funnel and can prevent inflammation of the kidney tissue. Thus, the funnel-shaped support 5014 can comprise a third diameter D7, which is less than a second diameter D5, the third diameter D7 being the distal portion of the drainage lumen 5002 from the second diameter D5. Close to the end 5010 of 5004. The outer surface 5028 of the edge 5026 can be a rounded, square edge, or any desired shape. Marginal 5026 may assist in providing additional support to the renal pelvis and internal renal tissue.

With reference to FIG. 47, in some embodiments, the edge 5200 of the distal end 5202 of at least one side wall 5204 can be molded. For example, the edge 5200 can comprise a plurality of substantially rounded edges 5206 or scallops, such as about 4 to about 20 or more rounded edges. The rounded rim 5206 can provide a larger surface area than the straight rim, support the renal pelvis or kidney tissue, and help prevent obstruction. The edge 5200 can have any desired shape, but preferably there is essentially no or no sharp edge to avoid injured tissue.

In some embodiments, as shown in FIGS. 41A-C and 45A-46B, the funnel-shaped support 5014 comprises a base portion 5024 adjacent to the distal portion 5004 of the drain lumen 5002. The base portion 5024 is the internal lumen 5032 of the discharge lumen 5002 of the proximal portion 5006 of the discharge lumen 5002 to allow fluid flow into the internal lumen 5032 of the proximal portion 5006 of the drainage lumen 5002. It comprises at least one internal opening 5030 that is consistent with. In some embodiments, the cross section of the opening 5030 is circular, but the shape may vary, such as elliptical, triangular, square, etc.

In some embodiments as shown in FIGS. 45A-46B, the central axis 5018 of the funnel-shaped support 5014 is offset with respect to the central axis 5034 of the proximal portion 5006 of the discharge lumen 5002. The offset distance X of the funnel-shaped support 5014 from the central axis 5018 with respect to the central axis 5034 of the proximal portion 5006 can range from about 0.1 mm to about 5 mm.

At least one internal opening 5030 of the base portion 5024 has a diameter D8 ranging from about 0.05 mm to about 4 mm (eg, shown in FIGS. 41C and 46B). In some embodiments, the diameter D8 of the internal opening 5030 of the base portion 5024 is approximately equal to the first inner diameter D6 of the adjacent proximal portion 5006 of the discharge lumen.

In some embodiments, the height H5 of at least one side wall 5016 of the funnel-shaped support 5014 to the second outer diameter D5 of at least one side wall 5016 of the funnel-shaped support 5014 is from about 1:25. It reaches about 5: 1.

In some embodiments, at least one internal opening 5030 of the base portion 5024 has a diameter D8 ranging from about 0.05 mm to about 4 mm and a height H5 of at least one side wall 5016 of the funnel-shaped support 5014. The second outer diameter D5 of the funnel-shaped support 5014 ranges from about 1 mm to about 25 mm and from about 5 mm to about 25 mm.

In some embodiments, the thickness T1 of at least one side wall 5016 of the funnel-shaped support 5014 (eg, shown in FIG. 41B) is about 0.01 mm to about 1.9 mm or about 0.5 mm to about 1 mm. Can reach. The thickness T1 can be generally uniform throughout at least one side wall 5016, or may vary as desired. For example, the thickness T1 of at least one side wall 5016 can be thinner or thicker than the base portion 5024 of the funnel-shaped support 5014 in the vicinity of the distal end 5010 of the distal portion 5004 of the drain lumen 5002.

With reference to FIGS. 42-44, along the length of at least one side wall 5016, the side wall 5016 is a straight line (as shown in FIGS. 41A and 43), a convex surface (as shown in FIG. 42), It can be concave (as shown in FIG. 44), or any combination thereof. As shown in FIGS. 42 and 44, the curvature of the side wall 5016 is approximated by the radius of curvature R from point Q such that the circle centered at Q meets the curve and has the same slope and curvature as the curve. be able to. In some embodiments, the radius of curvature ranges from about 2 mm to about 12 mm. In some embodiments, the funnel-shaped support 5014 has a substantially hemispherical shape, as shown in FIG.

In some embodiments, at least one side wall 5016 of the funnel-shaped support 5014 is formed from the balloon 5100, for example, as shown in FIGS. 5A, 5B, 57A, and 57B. The balloon 5100 can have any shape that provides a funnel-shaped support and blocks the remaining obstruction of the ureter, renal pelvis, and / or kidney. As shown in FIGS. 57A and 57B, the balloon 5100 has the shape of a funnel. The balloon can be inflated after insertion or contracted before removal by adding or removing gas or air through the gas port 5102. The gas port 5102 can simply be continuous with the inner 5104 of the balloon 5100, for example, the balloon 5100 is adjacent to the inner 5106 or 5108 outside the adjacent portion of the proximal portion 5006 of the discharge lumen 5002. Can be surrounded. The diameter D9 of the side wall 5110 of the balloon 5100 can range from about 1 mm to about 3 mm, with the side walls tapering or proximal to the distal end 5112 of the funnel-shaped support 5116 with a uniform diameter. It can vary along its length so as to taper towards the end 5114. The outer diameter D10 of the distal end 5112 of the funnel-shaped support 5116 can range from about 5 mm to about 25 mm.

In some embodiments, at least one side wall 5016 of the funnel-shaped support 5014 is continuous along height H5 of at least one side wall 5016, for example, as shown in FIGS. 41A, 42, 43, and 44. To do. In some embodiments, at least one side wall 5016 of the funnel-shaped support 5014 comprises a solid wall, for example, the side wall 5016 does not pass through the side wall 24 hours after contact with a fluid such as urine on one side. It is permeable.

In some embodiments, at least one side wall of the funnel-shaped support is discontinuous along the height or body of at least one side wall. As used herein, "discontinuity" means that at least one side wall allows fluid or urine to flow through it, for example by gravity or negative pressure, into the drainage lumen. It means that it has at least one opening. In some embodiments, the opening can be a conventional opening through a side wall, or an opening in a mesh material, or an opening in a permeable fabric. The cross-sectional shape of the opening can be circular or non-circular, such as rectangular, square, triangular, polygonal, oval, if desired. In some embodiments, the "opening" is the gap between adjacent coils within the retention portion of the catheter that constitutes the coiled tube or conduit.

As used herein, "opening" or "hole" means a continuous void space or channel through the side wall from the outside to the inside or vice versa. In some embodiments, at least one opening can have an area that can be the same or different and can range from about 0.002 mm ² to about 100 mm ² or about 0.002 mm ² to about 10 mm ² . As used herein, the "area" or "surface area" or "cross-sectional area" of an opening means the smallest or minimal plane area defined by the perimeter of the opening. For example, the opening is circular and has a diameter of about 0.36 mm (0.1 mm ² area) on the outside of the side wall, but only 0.05 mm (0.002 mm ² area) inside the side wall. Or if at some point on the opposite side of the side wall, the "area" would be 0.002 mm ² because it is the minimum or minimal plane area for flow through the openings in the side wall. .. If the opening is square or rectangular, the "area" would be length x width of plane area. For any other shape, the "area" can be determined by conventional mathematical calculations well known to those of skill in the art. For example, the "area" of an irregularly shaped opening is found by adapting the shape to fill the planar area of the opening, calculating the area of each shape, and adding the areas of each shape together.

In some embodiments, at least a portion of the side wall comprises at least one (one or more) openings. In general, the central axis of the opening can be approximately perpendicular to the planar outer surface of the side wall, or the opening can be angled with respect to the planar outer surface of the side wall. The size of the bore of the opening may be uniform throughout its depth, or the width may increase, decrease, or alternate through the opening from the outer surface of the side wall to the inner surface of the side wall. It may fluctuate along the depth depending on any of the above.

Here, referring to FIGS. 3A-3E, 30A, 30E, 31-34, 50, 54A, 54B, 55, and 56, in some embodiments, at least a portion of the side wall is at least one (one or more). ) Provide an opening. The opening can be located anywhere along the side wall. For example, the openings are uniformly positioned throughout the side wall, or within a defined area of the side wall, such as closer to the distal end of the side wall, or closer to the proximal end of the side wall, or the length or circumference of the side wall. Can be positioned vertically or horizontally or within a random group along. Although not intended to be constrained by any theory, when negative pressure is applied to the proximal end of the proximal portion of the drainage lumen, directly to the ureter, renal pelvis, and / or other kidney tissue. Adjacent openings in the proximal portion of the funnel-shaped support reduce negative pressure in the distal portion of the ureteral catheter, thereby reducing fluid or urine withdrawal or flow from the renal and renal pelvis. The opening is considered undesirable because it can cause and possibly inflame the tissue.

The number of openings can vary from 1 to 1000 or more, if desired. For example, in FIG. 50, six openings (three on each side) are shown. As discussed above, in some embodiments, at least one opening can be the same or different, respectively, and can range from about 0.002 mm ² to about 50 mm ² or about 0.002 mm ² to about 10 mm ^2. , Can have an area.

In some embodiments, as shown in FIG. 50, the opening 5500 can be located closer to the distal end 5502 of the side wall 5504. In some embodiments, the opening is located within the distal half 5506 of the side wall towards the distal end 5502. In some embodiments, the opening 5500 is evenly distributed around the circumference of the distal half 5506, or even closer to the distal end 5502 of the side wall 5504.

In contrast, in FIG. 54B, the opening 5600 is located near the proximal end 5602 of the inner side wall 5604 and does not come into direct contact with the tissue because the outer side wall 5606 is between the opening 5600 and the tissue. Alternatively, or in addition, one or more openings 5600 can be located near the distal end of the medial sidewall, if desired. The inner side wall 5604 and the outer side wall 5606 can be connected by one or more supports 5608 or ridges that connect the outer 5610 of the inner side wall 5604 to the inner 5612 of the outer side wall 5606.

In some embodiments, as shown in FIGS. 48 and 49, at least one side wall 5700, 5800 of the funnel-shaped supports 5702, 5802 comprises meshes 5704, 5804. The meshes 5704, 5804 include a plurality of openings 5706, 5806 to allow fluid flow through the drainage lumens 5708, 5808. In some embodiments, the maximum area of the opening is less than about 100 mm ² , or less than about 1 mm ² , or about 0.002 mm ² to about 1 mm ² , or about 0.002 mm ² to about 0.05 mm ² . be able to. The mesh 5704, 5804 can be formed from any suitable metal or polymeric material as discussed above.

In some embodiments, the funnel-shaped support further comprises a cover portion over the distal end of the funnel-shaped support. The cover portion may be formed as an integral part of the funnel-shaped support or may be connected to the distal end of the funnel-shaped support. For example, as shown in FIG. 49, the funnel-shaped support 5802 crosses the distal end 5812 of the funnel-shaped support 5802 and projects from the distal end 5812 of the funnel-shaped support 5802 with a cover portion 5810. Be prepared. The cover portion 5810 can have any desired shape such as flat, convex, concave, wavy, and combinations thereof. The cover portion 5810 can be formed from a mesh or any polymeric solid material, as discussed above. The cover portion 5810 can support the flexible tissue within the renal region and assist in promoting urine production.

In some examples, the funnel-shaped support comprises a porous material, for example, as shown in FIGS. 6 and 7. Figures 6 and 7 and suitable porous materials are discussed in detail below. Briefly, in FIGS. 6 and 7, the porous material itself is a funnel-shaped support. In FIG. 6, the funnel-shaped support is a wedge of porous material. In FIG. 7, the porous material is in the shape of a funnel. In some embodiments, such as FIG. 55, the porous material 5900 is located within 5902 inside the side wall 5904. In some embodiments, such as FIG. 56, the funnel-shaped support 6000 comprises a porous liner 6002 that is positioned adjacent to the interior 6004 of the side wall 6006. The thickness T2 of the porous liner 6002 can range from, for example, about 0.5 mm to about 12.5 mm. The area of the opening in the porous material can be from about 0.002 mm ² to about 100 mm ² or less.

In some embodiments, a ureteral catheter with a funnel-shaped support uses a conduit through the urethra into the bladder into the patient's urinary tract, more specifically the renal pelvis region / kidney. Can be deployed within. The funnel-shaped support 6100 is in a crushed state (shown in FIG. 58) and is placed in the ureteral sheath 6102. To deploy a ureteral catheter, a healthcare professional will insert a cystoscope into the urethra and provide a channel for the tool to enter the bladder. The ureter is visualized and the guidewire will be inserted through the cystoscope and ureter until the tip of the guidewire reaches the renal pelvis. The cystoscope will potentially be removed and a "pusher tube" will be sent over the guide wire to the renal pelvis. The guide wire will be removed while the "pusher tube" remains in place and acts as a deployable sheath. A ureteral catheter is inserted through the pusher tube / sheath and the catheter tip will be activated once it extends beyond the end of the pusher tube / sheath. The funnel-shaped support will extend radially and take an unfolded position.

In some embodiments shown in FIG. 27-30, the retention portion 1230 is integral with the tube 1222. In another embodiment, the retention portion 1230 can comprise a separate tubular member that connects to and extends from a tube or drain lumen 1224.

In some embodiments, the retention portion comprises a plurality of radial extending coils. The coil is constructed in the shape of a funnel, thereby forming a funnel-shaped support. Some examples of coiled funnel supports are shown in FIGS. 1-3E and 27-34.

In some embodiments, at least one side wall of the funnel-shaped support comprises at least a first coil having a first diameter and a second coil having a second diameter, the first. The diameter is less than the second diameter, and the maximum distance between a part of the side wall of the first coil and a part of the adjacent side wall of the second coil ranges from about 0 mm to about 10 mm. In some embodiments, the first diameter of the first coil ranges from about 1 mm to about 10 mm and the second diameter of the second coil ranges from about 5 mm to about 25 mm. In some embodiments, the diameter of the coil increases towards the distal end of the discharge lumen, resulting in a helical structure with a tapered or partially tapered configuration.

In some embodiments, at least one side wall of the funnel-shaped support comprises an inward facing side and an outward facing side, as discussed below, with the inward facing side. Provided at least one opening to allow fluid flow into the drain lumen, with or without an opening on the outward facing side. In some embodiments, the at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² .

In some embodiments, the first coil comprises a side wall that includes a radial inward facing side and a radial outward facing side, and the first coil is radially inward facing. The side provided with at least one opening to allow fluid flow into the drainage cavity.

In some embodiments, the first coil has a side wall that includes a radial inward facing side and a radial outward facing side, and the first coil is radially inward facing. The side provided with at least two openings to allow fluid flow into the drainage cavity.

In some embodiments, the first coil comprises a side wall that includes a radial inward facing side and a radial outward facing side, and the first coil is radially outwardly oriented. The side was essentially free or absent of one or more openings.

In some embodiments, the first coil has a side wall that includes a radial inward facing side and a radial outward facing side, and the first coil is radially inward facing. The former side is provided with at least one opening to allow fluid flow into the drainage lumen, and the radial outward facing side is essentially free of or more than one opening. Absent.

Now referring to FIGS. 27-34, in some embodiments, the distal portion 1218 comprises an open distal end 1220 for drawing fluid into the drain lumen 1224. The distal portion 1218 of the ureteral catheter 1212 further comprises a retention portion 1230 for maintaining the distal portion 1218 of the drainage lumen or tube 1222 within the ureter and / or kidney. In some embodiments, the retention portion comprises a plurality of radially extending coils 1280, 1282, 1284. The retention portion 1230 is flexible and flexible and can allow the retention portion 1230 to be positioned within the ureter, renal pelvis, and / or kidney. For example, the retention portion 1230 is preferably flexible enough to absorb the forces exerted on the catheter 1212 and prevent such forces from being transmitted to the ureter. Further, if the retention portion 1230 is pulled in the proximal direction P (shown in FIGS. 27 and 28) towards the patient's bladder 10, the retention portion 1230 can be pulled through the ureters 6 and 8. It can be flexible enough to begin unwinding or straightening. In some embodiments, the retention portion 1230 is integral with the tube 1222. In another embodiment, the retention portion 1230 can comprise a separate tubular member that connects to and extends from a tube or drain lumen 1224. In some embodiments, the catheter 1212 comprises a radiation impermeable band 1234 (shown in FIG. 29) located on the tube 1222 at the proximal end of the retention portion 1230. The radiation opaque band 1234 is visible by fluoroscopic imaging during deployment of catheter 1212. In particular, the user can monitor the advance of band 1234 through the urethra by fluoroscopy and determine when the retention portion 1230 is in the renal pelvis and ready for deployment.

In some embodiments, the retention portion 1230 comprises a perforation, drain port, or opening 1232 within the side wall of the tube 1222. As described herein, the position and size of the openings 1232 can vary depending on the desired volumetric flow rate for each opening and the size constraints of the retaining portion 1230. In some embodiments, the diameter of the opening 1232 extends to about 0.05mm~ about 2.5 mm, has an area of about 0.002mm ² ~5.00mm ^2. The opening 1232 can be positioned so as to extend along the side wall of the tube 1222 in any desired direction, such as longitudinal and / or axial. In some embodiments, the spacing between the openings 1232 can range from about 1.5 mm to about 15 mm. Fluid passes through the drainage lumen 1234 through one or more of the perforations, drainage ports, or openings 1232. Desirably, the openings 1232 are positioned so that when negative pressure is applied to the drain lumen 1224, they are not obstructed by ureters 6, 8 or kidney tissue. For example, as described herein, the opening 1234 can be positioned on the coil of retention portion 1230 or an internal portion of other structure to avoid blockage of opening 1232. In some embodiments, the central portion 1226 and proximal portion 1228 of tube 1222 have essentially no or no perforations, ports, openings, or openings of openings along those portions of tube 1222. Blockage can be avoided. In some embodiments, portions 1226, 1228, which are essentially free of perforations or openings, include substantially fewer openings than other parts of the tube 1222. For example, the total area of the opening 1232 of the distal portion 1218 may be greater than or substantially greater than the total area of the opening of the proximal portion 1226 and / or the distal portion 1228 of the tube 1222.

In some embodiments, the openings 1232 are sized and spaced to improve fluid flow through the retention portion 1230. In particular, we have found that when negative pressure is applied to the drainage lumen 1224 of the catheter 1212, most of the fluid is drawn into the drainage lumen 1224 through a recent perforation or opening 1232. .. Larger size or more openings are available to improve fluid dynamics so that fluid is also received through the more distal openings and / or through the open distal end 1220 of the tube 1222. , Can be provided towards the distal end of the retention portion 1230. For example, the total area of the opening 1232 on the length of the tube 1222 near the proximal end of the retention portion 1230 is an opening of similar size length of the tube 1222 located near the open distal end 1220 of the tube 1222. It may be less than the total area of the unit 1232. In particular, less than 90%, preferably less than 70%, more preferably less than 55% of the fluid flow is located in the discharge lumen 1224 near the proximal end of the retention portion 1230 or a single opening 1232 or It may be desirable to produce a flow distribution through the drain lumen 1224, which is drawn through a small number of openings 1232.

In many embodiments, the opening 1232 is generally circular in shape, but triangles, ellipses, squares, rhombuses, and any other opening shape may also be used. Further, as will be appreciated by those skilled in the art, the shape of the opening 1232 may change as the tube 1222 transitions between a non-coiled or extended position and a coiled or deployed position. The shape of the opening 1232 may vary (eg, the orifice may be circular in some positions and slightly extended in other positions), but the area of the opening 1232 may be expanded or expanded. Note that it is substantially similar in the extended or non-coiled position as compared to the coiled position.

In some embodiments, the drainage lumen 1224 defined by the tube 1222 is one of the tubes 1222 configured to be located within the distal portion 1218 (eg, ureters 6, 8 and renal pelvis 20, 21). A section (shown in FIGS. 27-29) and a central section 1226 (eg, a tube 1222 configured to extend from the distal section through the ureteral opening 16 into the patient's bladder 10 and urethra 12). (Shown in FIGS. 27-29) and a proximal portion 1228 (eg, a portion of tube 1222 extending from the urethra 12 to the external fluid collection vessel and / or pump 2000). In one preferred embodiment, the combined length of the proximal portion 1228 and the central portion 1226 of the tube 1222 is about 54 ± 2 cm. In some embodiments, the central portion 1226 and proximal portion 1228 of the tube 1222 include a distance marking 1236 (shown in FIG. 29) on the side wall of the tube 1222, which is the tube during deployment of the catheter 1212. 1222 can be used to determine the distance inserted into the patient's urinary tract.

As shown in FIG. 27-39D, the exemplary ureteral catheter 1212 comprises at least one extension body or tube 1222, the interior of which defines one or more drainage channels or lumens, such as a drainage lumen 1224. Or configure. Tube 1222 sizes can range from about 1 Fr to about 9 Fr (French catheter scale). In some embodiments, the tube 1222 can have an outer diameter ranging from about 0.33 to about 3.0 mm and an inner diameter ranging from about 0.165 to about 2.39 mm. In one embodiment, the tube 1222 is 6 Fr and has an outer diameter of 2.0 ± 0.1 mm. The length of the tube 1222 can range from about 30 cm to about 120 cm, depending on the patient's age (eg, pediatric or adult) and gender.

The tube 1222 is formed from a flexible and / or deformable material and can facilitate the advancement and / or positioning of the tube 1222 within the bladder 10 and the ureters 6, 8 (shown in FIGS. 27 and 28). .. For example, the tube 1222 can be formed from a material comprising a biocompatible polymer, polyvinyl chloride, polytetrafluoroethylene (PTFE) such as Teflon (R), silicone coated latex, or silicone. In one embodiment, the tube 1222 is made of thermoplastic polyurethane. Tube 1222 can also contain or be impregnated with one or more of copper, silver, gold, nickel-titanium alloys, stainless steel, and titanium. In some embodiments, the tube 1222 is impregnated with, or formed from, a material visible by fluoroscopic imaging. For example, the biocompatible polymer forming tube 1222 can be impregnated with barium sulphate or a similar radiation impermeable material. Therefore, the structure and position of tube 1222 is visible to fluorescence perspective.

Spiral Coil Retention Section With reference to FIGS. 30A-30E, the exemplary retention portion 1230 comprises spiral coils 1280, 1282, 1284. In some embodiments, the retention portion 1230 comprises a first coil, i.e., a half coil 1280 and two complete coils such as a second coil 1282 and a third coil 1284. As shown in FIGS. 30A-30D, in some embodiments, the first coil comprises a half coil extending 0 to 180 degrees around the curve center axis A of the retention portion 1230. In some embodiments, as shown, the curve center axis A is substantially straight and extends the same as the curve center axis of tube 1222. In another embodiment, the curved central axis A of the retention portion 1230 is curved to give the retention portion 1230 a cornucopia shape. The first coil 1280 can have a diameter D1 of about 1 mm to 20 mm, preferably about 8 mm to 10 mm. The second coil 1282 extends 180 degrees to 540 degrees along the retention portion 1230, having a diameter D2 of about 5 mm to 50 mm, preferably about 10 mm to 20 mm, more preferably about 14 mm ± 2 mm. It can be a perfect coil. The third coil 1284 can be a complete coil extending from 540 degrees to 900 degrees and having a diameter D3 of 5 mm and 60 mm, preferably about 10 mm to 30 mm, more preferably about 18 mm ± 2 mm. .. In another embodiment, the plurality of coils 1282, 1284 can have the same inner diameter and / or outer diameter. For example, the outer diameters of the complete coils 1282 and 1284 can be about 18 ± 2 mm, respectively.

In some embodiments, the overall height H1 of the retention portion 1230 ranges from about 10 mm to about 30 mm, preferably about 18 ± 2 mm. The height H2 of the gap between the coils 1284, that is, between the side wall of the tube 1222 of the first coil 1280 and the adjacent side wall of the tube 122 of the second coil 1282, is less than 3.0 mm, preferably about 0. It is .25 mm to 2.5 mm, more preferably about 0.5 mm to 2.0 mm.

The retention portion 1230 can further include a most distal curved portion 1290. For example, the most distal portion 1290 of the retention portion 1230, including the open distal end 1220 of the tube 1222, can be bent inward with respect to the curvature of the third coil 1284. For example, the curve center axis X1 of the most distal portion 1290 (shown in FIG. 30D) can extend from the distal end 1220 of the tube 1222 towards the curve center axis A of the retention portion 1230.

The retention portion 1230 moves between a contraction position where the retention portion 1230 is linear for insertion into the patient's urethra and a deployment position where the retention portion 1230 comprises spiral coils 1280, 1282, 1284. It is possible. In general, the tube 1222 is naturally urged towards the coiled configuration. For example, a non-coiled or substantially vertical guide wire can be inserted through the retention portion 1230, for example, as shown in FIGS. 31-35, to keep the retention portion 1230 in its linear contraction position. When the guide wire is removed, the retaining portion 1230 naturally transitions to its coiled position.

In some embodiments, the openings 1232 are located essentially or only on the radial inward facing side 1286 of the coils 1280, 1282, 1284 to prevent blockage or blockage of the openings 1232. The radial outward facing side 1288 of the coils 1280, 1282, 1284 may essentially be free of openings 1232. In a similar embodiment, the total area of the opening 1232 on the inwardly facing side 1286 of the retaining portion 1230 is substantially greater than the total area of the opening 1232 on the radial outward facing side 1288 of the retaining portion 1230. Can be big. Thus, when negative pressure is induced in the ureter and / or renal pelvis, the mucosal tissue of the ureter and / or kidney can be towed against the retention portion 1230, with some on the lateral periphery of the retention portion 1230. The opening 1232 can be closed. However, the opening 1232, located on the radial inward side 1286 of the retention portion 1230, is not significantly blocked when such tissue contacts the outer periphery of the retention portion 1230. Therefore, the risk of tissue damage from biting or contact with the outlet opening 1232 can be reduced or eliminated.

Hole or Opening Distribution Examples In some examples, the first coil 1280 can have no or essentially no 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 complete coils 1282, 1284. Examples of various arrangements of openings or openings 1332 that can be used for coiled retainers (such as coiled retainer 1230 shown in FIGS. 30A-30E) are illustrated in FIGS. 31-34. As shown in FIGS. 31-34, the retention portion is depicted in its non-coiled or linear position as it occurs when the guide wire is inserted through the drain lumen.

An exemplary retention portion 1330 is illustrated in FIG. In order to more clearly explain the positioning of the opening of the retention portion 1330, the retention portion 1330 is referred to herein as the most recent or first division 1310, second division 1312, third division 1314, fourth. 1316, a fifth section 1318, and a plurality of sections or perforation sections such as the most distal or sixth section 1320. Those skilled in the art will appreciate that additional compartments can be included, if desired. As used herein, "classification" refers to the discrete length of tube 1322 within the retention portion 1330. In some embodiments, the compartments are equal in length. In other embodiments, some compartments can have the same length and other compartments can have different lengths. In other embodiments, each section has a different length. For example, the compartment can have a length L1-L6 of about 5 mm to about 35 mm, preferably about 5 mm to 15 mm.

In some embodiments, each compartment comprises one or more openings. In some embodiments, each section comprises a single opening 1332. In another embodiment, the first section 1310 comprises a single opening 1332 and the other section comprises a plurality of openings 1332. In other embodiments, the different compartments comprise one or more openings 1332, each of which has a different shape or a different total area.

In some embodiments, such as the retention portion 1230 shown in FIGS. 30A-30E, the first coil, i.e. half coil 1280, extending from 0 to about 180 degrees of the retention portion 1230 has no openings. Or it can be essentially non-existent. The second coil 1282 can include a first compartment 1310 that extends from about 180 to 360 degrees. The second coil 1282 can also include second and third compartments 1312, 1314, located at about 360 to 540 degrees of the retention portion 1230. The third coil 1284 can include fourth and fifth compartments 1316, 1318, located at about 540 to 900 degrees of the retention portion 1230.

In some embodiments, the opening 1332 can be sized so that the total area of the openings in the first section 1310 is less than the total area of the openings in the adjacent second section 1312. .. Similarly, if the retention portion 1330 further comprises a third section 1314, the opening of the third section 1314 has a total area larger than the total area of the openings of the first section 1310 or the second section 1312. Can have. The openings in the fourth section 1316, the fifth section 1318, and the sixth section 1320 also have a gradual increase in total area and / or number of openings to improve fluid flow through tube 1222. You may.

As shown in FIG. 31, the retaining portion 1230 of the tube includes five compartments 1310, 1312, 1314, 1316, including single openings 1332, 1334, 1336, 1338, 1340, respectively. The retention portion 1230 also includes a sixth section 1320, which includes the open distal end 1220 of the tube 1222. In this embodiment, the opening 1232 of the first section 1310 has a minimum total area. For example, the total area of the openings 1332 of the first section is about 0.002 mm ² ~ about 2.5 mm ^2, or about 0.01 mm ² 1.0 mm ^2, or about 0.1 mm ² to 0.5 mm ^2, Can be. In one embodiment, the opening 1332 is about 55 mm from the distal end 1220 of the catheter and has a diameter of 0.48 mm and an area of 0.18 mm ² . In this embodiment, the total area of the openings 1334 of the second section 1312 is greater than the total area of the opening 1232 of the first section 1310, that spans approximately 0.01 mm ² 1.0 mm ² size Can be done. Third opening 1336, the fourth opening 1338, and also the fifth opening 1350 also may range from about 0.01 mm ² 1.0 mm ² size. In one embodiment, the second opening 1334 is about 45 mm from the distal end of the catheter 1220 and has a diameter of about 0.58 mm and an area of about 0.27 mm ² . The third opening 1336 can be about 35 mm from the distal end of the catheter 1220 and have a diameter of about 0.66 mm. The fourth opening 1338 can be about 25 mm from the distal end 1220 and have a diameter of about 0.76 mm. The fifth opening 1340 can be about 15 mm from the distal end 1220 of the catheter and have a diameter of about 0.889 mm. In some embodiments, the open distal end 1220 of tube 1222 has a maximum opening with an area of about 0.5 mm ² to about 5.0 mm ² or larger. In one embodiment, the open distal end 1220 has a diameter of about 0.97 mm and an area of about 0.74 mm ² .

As described herein, openings 1332, 1334, 1336, 1338, 1340 are of the fluid passing through the first opening 1332 when negative pressure is applied to the drainage lumen 1224 of the catheter 1212. The volume flow rate can be positioned and sized so that it closely corresponds to the volume flow rate of the opening in the more distal section. As described above, if each opening has the same area, when negative pressure is applied to the discharge lumen 1224, the volumetric flow rate of the fluid passing through the most recent position of the first opening 1332 will be It will be substantially greater than the volumetric flow rate of the fluid passing through the opening 1334 closer to the distal end 1220 of the retention portion 1330. Although not intended to be constrained by any theory, when negative pressure is applied, the pressure difference between the inside of the discharge lumen 1224 and the outside of the discharge lumen 1224 becomes the most recent opening. It is believed to grow larger within the region and decrease at each opening moving towards the distal end of the tube. For example, the size and position of openings 1332, 1334, 1336, 1338, 1340 is such that the volumetric flow rate for the fluid flowing into the opening 1334 of the second section 1312 is that of the opening 1332 of the first section 1310. It can be selected to be at least about 30% of the volumetric flow rate of the fluid flowing into it. In other embodiments, the volumetric flow rate for the fluid flowing in the most recent or first segment 1310 is less than about 60% of the total volumetric flow rate for the fluid flowing through the proximal portion of the discharge lumen 1224. .. In another embodiment, the volumetric flow rates for the fluid flowing into the openings 1332, 1334 of the two most recent compartments (eg, first compartment 1310 and second compartment 1312) are negative pressures, eg, about. When a negative pressure of −45 mmHg is applied to the proximal end of the drainage lumen, it can be less than about 90% of the volumetric flow rate of the fluid flowing through the proximal portion of the drainage lumen 1224.

As will be appreciated by those skilled in the art, volumetric flow rates and distributions for catheters or tubes with multiple openings or perforations can be directly measured or calculated in a variety of different ways. As used herein, "volume flow" is a method for actual measurement of volume flow downstream of and adjacent to each opening or for "calculated volume flow" as described below. Means use.

For example, an actual measurement of the volume of fluid dispersed over time can be used to determine the volume flow rate through each of the openings 1332, 1334, 1336, 1338, 1340. In one exemplary experimental sequence, a multichamber vessel is provided around the retention portion 1330, comprising individual chambers sized to receive compartments 1310, 1312, 1314, 1316, 1318, 1320 of the retention portion 1330. It is sealed and can be enclosed. Each opening 1332, 1334, 1336, 1338, 1340 can be sealed within one of the chambers. The amount of fluid volume drawn from the individual chambers into the tube 3222 through each opening 1332, 1334, 1336, 1338, 1340 is measured when negative pressure is applied and over time into each opening. The amount of fluid volume drawn can be determined. The cumulative amount of fluid volume collected in tube 3222 by the negative pressure pump system will be comparable to the sum of the fluids drawn into each opening 1332, 1334, 1336, 1338, 1340.

Alternatively, the volumetric fluid flow rates through the different openings 1332, 1334, 1336, 1338, 1340 are mathematically calculated using equations for modeling fluid flow through the tubular body. Can be done. For example, the volumetric flow rate of fluid passing through the openings 1332, 1334, 1336, 1338, 1340 into the drainage lumen 1224 is described in detail below in connection with mathematical examples and FIGS. 35A-35C. As such, it can be calculated based on the mass transfer shell balance assessment. Steps for deriving the mass balance equation and calculating the flow distribution between openings 1332, 1334, 1336, 1338, 1340 or the volumetric flow rate associated therewith are also described in detail below in connection with FIGS. 35A-35C. Will be done.

Another exemplary retention portion 2230 with openings 2332, 2334, 2336, 2338, 2340 is illustrated in FIG. As shown in FIG. 32, the retention portion 2230 comprises a number of smaller perforations or openings 2332, 2334, 2336, 2338, 2340. The openings 2332, 2334, 2336, 2338, 234 can each have substantially the same cross-sectional area. As shown in FIG. 32, the retention portion 2330 comprises six compartments 2310, 2312, 2314, 2316, 2318, 2320 as described above, each compartment 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 per section is such that the total area of openings 1332 within each section is increased compared to the proximally adjacent sections. As such, it increases towards the distal end 1220 of tube 1222.

As shown in FIG. 32, the openings 2332 of the first section 2310 are arranged along the first virtual line V1 substantially parallel to the curve center axis X1 of the retention portion 2230. The openings 2334, 2336, 2338, 2340 of the second division 2312, the third division 2314, the fourth division 2316, and the fifth division 2318 have the openings 2334, 2336, 2338 of these divisions, respectively. The 2340 is also positioned on the side wall of the tube 2222 in an increasing number of rows so as to align around the circumference of the tube 2222. For example, in some of the openings 2334 of the second section 2312, the second virtual line V2 extending around the circumference of the side wall of the pipe 2222 contacts at least a part of the plurality of openings 2334. Positioned. For example, the second section 2312 may include two or more rows of perforations or openings 2334, where each opening 2334 has an equal cross-sectional area. Further, in some embodiments, at least one of the columns of the second section 2312 is parallel to the curve center axis X1 of the tube 2222, but not co-extended with the first virtual line V1. It can be aligned along the virtual line V3 of 3. Similarly, the third section 2314 can include five rows of perforations or openings 2336, where each opening 2336 has an equal cross-sectional area, and the fourth section 2316 has seven rows of perforations or openings 2338. The fifth section 2318 can be provided with nine rows of perforations or openings 2340. As in the previous embodiment, the sixth section 2320 comprises a single opening, i.e., the open distal end 2220 of the tube 2222. In the embodiment of FIG. 32, the openings each have the same area, but the area of one or more openings can vary, if desired.

Another exemplary retention portion 3230 with openings 3332, 3334, 3336, 3338, 3340 is shown in FIG. The retention portion 3230 of FIG. 33 includes a plurality of similarly sized perforations or openings 3332, 3334, 3336, 3338, 3340. As in the previous embodiment, the retention portion 3230 can be divided into six compartments 3310, 3312, 3314, 3316, 3318, 3320, each comprising at least one opening. The most recent or first segment 3310 includes one opening 3332. The second section 3312 includes two openings 3334 aligned along a virtual line V2 extending around the circumference of the side wall of tube 3222. The third segment 3314 comprises a group of three openings 3336 located at the vertices of the virtual triangle. The fourth section 3316 comprises a group of four openings 3338 located at the corners of a virtual square. The fifth section 3318 comprises 10 openings 3340 positioned to form a rhombus on the side wall of the tube 3222. As in the previous embodiment, the sixth section 3320 comprises a single opening, i.e., an open distal end 3220 of tube 3222. The area of each opening can range from about 0.001 mm ² to about 2.5 mm ² .

Another exemplary retention portion 4230 with openings 4332, 4334, 4336, 4338, 4340 is illustrated in FIG. The openings 4332, 4334, 4336, 4338, 4340 of the retaining portion 4330 have different shapes and sizes. For example, the first segment 4310 includes a single circular opening 4332. The second section 4312 has a circular opening 4334 with a cross-sectional area greater than the opening 4332 of the first section 4310. The third section 4314 comprises three triangular openings 4336. The fourth section 4316 comprises a large circular opening 4338. The fifth section 4318 comprises a diamond-shaped opening 4340. As in the previous embodiment, the sixth section 4320 comprises an open distal end 4220 of tube 4222. FIG. 34 illustrates an embodiment of an array of differently shaped openings within each section. It is understood that the shape of each opening within each compartment can be selected independently, for example, the first compartment 4310 can have one or more diamond-shaped openings or other shapes. I want to. The area of each opening can range from about 0.001 mm ² to about 2.5 mm ² .

(Example)
Calculation of Volume Flow Rate and Percentage of Flow Distribution Although the various arrangements of openings for the retention portion of the ureteral catheter 1212 have been described, to determine the calculated percentage of flow distribution and the calculated volume flow rate through the catheter. Method will be described in detail here. A schematic representation of an exemplary catheter with a side wall opening indicating the location of a portion of the tube or drain lumen used in the calculations below is shown in FIG. 38. The calculated percentage of flow distribution refers to the percentage of total fluid flowing through the proximal portion of the drainage lumen that enters the drainage lumen through different openings or compartments in the retention portion. The calculated volumetric flow rate refers to the fluid flow rate per unit time through different parts of the drain lumen or opening of the retention section. For example, the volumetric flow rate for the proximal portion of the drainage lumen describes the flow rate for the total amount of fluid passing through the catheter. Volumetric flow rate with respect to an opening refers to the volume of fluid passing through the opening into the drain lumen per unit time. In Table 3-5 below, flow is described as a percentage of total fluid flow or total volume flow relative to the proximal portion of the drain lumen. For example, an opening with a 100% flow distribution means that all fluid entering the discharge lumen has passed through the opening. An opening with a distribution of 0% would indicate that fluid within the drain lumen did not enter the drain lumen through the opening.

These volumetric flow rate calculations were used to determine and model the fluid flow through the retention portion 1230 of the ureteral catheter 1212 shown in FIGS. 27-34. In addition, these calculations show that adjusting the area of the openings and the linear distribution of the openings along the retentions results in the distribution of fluid flow through different openings. For example, reducing the area of the recent opening reduces the proportion of fluid drawn into the catheter through the recent opening and increases the proportion of fluid drawn into the more distal opening of the retention portion. Let me.

For the following calculations, an 86 cm tube length with an inner diameter of 0.97 mm and an inner diameter of the end hole of 0.97 mm was used. The density of urine was 1.03 g / mL and had a friction coefficient μ of 8.02 × 10-3 Pa · S (8.02 × 10-3 kg / sec · m) at 37 ° C. The urine volume flow rate passing through the catheter was 2.7 ml / min (Q _Total ), as determined by experimental measurements.

Calculating the volume flow rate is five through any perforations or openings 1232 of the section of retention portion (referred to herein as a volume flow Q ₂ to Q _6), through the open distal end 1220 (the the specification, referred to as volume flow rate Q _1), the sum of the volumetric flow rate, as shown in equation 2, exit from the proximal end of the tube 1222 away 10cm~60cm distance from the end of the proximal opening It is determined by the volumetric material balance equation, which is equal to the total volumetric flow rate (Q _Total ).
Q _Total = Q ₁ + Q ₂ + Q ₃ + Q ₄ + Q ₅ + Q ₆ (Equation 2)

The modified loss factor (K') for each segment takes into account three types of loss factors in the catheter model, namely the resulting pressure drop at the pipe inlet (eg, the opening of the pipe 1222 and the open distal end). It is based on the inlet loss coefficient, the friction loss factor considering the pressure loss resulting from the friction between the fluid and the pipe wall, and the flow merging loss coefficient considering the pressure loss resulting from the interaction of the two flows together.

The inlet loss factor depends on the shape of the orifice or opening. For example, a tapered or nozzle-shaped orifice will increase the flow rate into the discharge lumen 1224. Similarly, sharp-edged orifices will have different flow properties than orifices with undefined edges. For the purposes of the following calculations, it is assumed that the opening 1232 is a side orifice opening and the open distal end 1220 of the tube 1222 is a sharp-edged opening. The cross-sectional area of each opening is considered constant through the side wall of the pipe.

The friction loss factor approximates the pressure drop resulting from the friction between the fluid and the adjacent inner wall of the pipe 1222. Friction loss is defined according to the following equation.

The flow merging loss factor is derived from the loss factor for combining flows at a 90 degree branch angle. Values for the loss factor were determined from Charts 13.10 and 13.11 of Miller DS, International Flow Systems, 1990 (incorporated herein by reference). The chart shows the ratio of the inlet orifice area (referred to as A1 in the chart) to the pipe cross-sectional area (referred to as A3 in the chart) to the inlet orifice volume flow rate (Q1 in the chart) vs. the resulting combined pipe. The ratio of volume flow rate (Q3 in the chart) is used. For example, for an area ratio of 0.6 between the area of the opening and the area of the discharge lumen, the following flow merging loss factors (K ₁₃ and K ₂₃ ) will be used.

To calculate the total manifold loss factor (K), the model is separated into so-called "reference stations", the pressure of the two paths (eg, the flow through the opening and the flow through the discharge lumen of the pipe) and It is necessary to gradually process and equilibrate the flow distribution to reach each station starting from the distal tip of the most recent "station". A graphical representation of the different stations used for this calculation is shown in FIG. For example, the most distal "station" A is the distal open end 1220 of tube 122. The second station A'is the most distal opening on the side wall of tube 122 (eg, the opening of fifth section 1318 in FIGS. 31-34). The next station B is for flow through the drain lumen 1224, just proximal to the A'opening.

To calculate the loss between station A (distal opening) and station B for fluid entering through the open distal end (path 1) of tube 1222, the modified loss factor (K') is equal to: Become.

Similarly, the second route to station B is through the opening 1334 of the fifth section 1318 (shown in FIG. 31-34) of the retention portion 1330. The correction loss calculation for path 2 is calculated as follows.

The modified loss factors for both Path 1 and Path 2 must be equalized to ensure that the volumetric flow rates (Q ₁ and Q ₂ ) reflect the equilibrium distribution within the manifold at station B. The volume flow rate is adjusted until an equal correction loss factor for both paths is achieved. The volume flow rate can be adjusted to represent a fraction of the total volume flow rate ( _Q'Total ), which is assumed to be 1 for the purposes of this stepwise solution. Depending on the equalization of the two correction loss factors, the equalization of the two paths can then proceed to reach station C (fourth segment 1316 in FIGS. 31-34).

The loss factors between station B (flow through the discharge lumen in the fifth section 1318) and station C (flow through the lumen in the fourth section 1316) are equations 5.1 and 5.2. Calculated in a similar fashion, as shown by. For example, for path 1 (stations B to C), the modified loss factor (K') for the opening in the fourth section 1316 is defined as follows.

For path 2 (stations B to C), the correction loss factor (K') based on the flow area of the opening in the fourth section 1316 is defined as follows.

As with the previous station, the modified loss factors for both Path 1 and Path 2 ensure that the volumetric flow rates (Q ₁ , Q ₂ , and Q ₃ ) reflect the equilibrium distribution in the manifold to station C. Must be equalized to. Depending on the equalization of the two correction loss factors, then the equalization of the two paths can proceed to reach station D, station E, and station F. The stepwise solution process proceeds through each station as demonstrated until the final station, in this case the corrected loss factor for station F, is calculated. The total loss factor (K) for the manifold can then be calculated using the actual Q _Total (volume flow rate through the proximal portion of the discharge lumen) determined through experimental measurements.

The fractional volume flow rates calculated through the stepwise run are then multiplied by the actual total volume flow rate (Q _Total ) to provide each opening 1232 (shown in FIG. 30A-30E) and the open distal end 1220. The flow rate through can be determined.

(Example)
Examples are provided below for calculated volumetric flow rates and are shown in Table 3-5 and FIGS. 35A-35C.

(Example 1)
The first embodiment illustrates the distribution of fluid flow in a retainer tube with different sized openings, corresponding to the embodiment of the retainer 1330 shown in FIG. As shown in Table 3, the most recent opening (Q ₆ ) has a diameter of 0.48 mm and the most distal opening (Q ₅ ) on the side wall of the tube has a diameter of 0.88 mm. and, the open distal end of the tube _{(Q 6)} had a diameter of 0.97 mm. Each opening was circular.

The flow distribution and calculated volumetric flow percentage percentages were determined as follows.

To calculate the flow distribution for each "station" or opening, the calculated _K'value was multiplied by the actual total volume flow rate (Q _Total ) to determine the flow rate through each perforation and distal end hole. .. Alternatively, the calculation results can be presented as a percentage of total flow or flow distribution, as shown in Table 3. As shown in Table 3 and FIG. 35C, the percentage of flow distribution through the most recent opening (Q6) (% flow distribution) was 56.1%. The flow rate through the two most recent openings (Q6 and Q5) was 84.6%.

As demonstrated in Example 1, increasing the diameter of the perforation from the proximal region to the distal region of the retention portion of the tube results in a more evenly dispersed flow across the retention portion.

(Example 2)
In Example 2, each opening has the same diameter and area. As shown in Table 4 and FIG. 35A, in that case, the flow distribution through the most recent opening is 86.2% of the total flow through the tube. The flow distribution through the second opening is 11.9%. Therefore, in this example, it was calculated that 98.1% of the fluid passing through the drain lumen entered the lumen through the two most recent openings. Compared to Example 1, Example 2 increased the flow rate through the proximal end of the tube. Therefore, Example 1 provides a wider flow distribution in which a larger percentage of the fluid enters the drain lumen through openings other than the most recent opening. Thus, fluid can be collected more efficiently through multiple openings, reducing fluid stagnation and improving the distribution of negative pressure through the renal pelvis and / or kidney.

(Example 3)
Example 2 also illustrates the flow distribution for openings having the same diameter. However, as shown in Table 5, the openings are closer together (10 mm vs. 22 mm). As shown in Table 5 and FIG. 35B, 80.9% of the fluid passing through the drainage lumen entered the drainage lumen through the most recent opening (Q6). 96.3% of the fluid in the drain lumen entered the drain lumen through the two most recent openings (Q5 and Q6).

Systems for Inducing Negative Pressure With reference to FIG. 27, an exemplary system 1100 for inducing negative pressure into the patient's urethra to increase renal perfusion is illustrated. System 1100 comprises one or two ureteral catheters 1212 connected to fluid pump 2000 to generate negative pressure. More specifically, the patient's urethra comprises the patient's right kidney 2 and left kidney 4. Kidneys 2 and 4 are involved in the clearance of waste compounds from the body through hemofiltration and urine. Urine produced by the right and left kidneys 4 is drained into the patient's bladder 10 through the renal tubules, the right and left ureters 8, which are connected to the kidneys in the renal pelvis 20, 21. To. Urine can be conducted through the ureters 6 and 8 by the peristalsis and gravity of the ureteral wall. The ureters 6 and 8 enter the bladder 10 through the ureteral ostium or opening 16. The bladder 10 is a flexible and substantially hollow structure adapted to collect urine until it is excreted from the body. The bladder 10 can transition from an empty position (indicated by reference line E) to a full position (indicated by reference line F). Normally, when the bladder 10 reaches a substantially full state, urine is allowed to drain from the bladder 10 to the urethra 12 through the urethral sphincter muscle or opening 18 located in the lower portion of the bladder 10. The contraction of the bladder 10 may respond to the stress and pressure applied on the triangular region 14 of the bladder 10, which is the triangular region extending between the ureteral opening 16 and the urethral opening 18. The triangular region 14 is sensitive to stress and pressure so that the pressure exerted on the triangular region 14 increases as the bladder 10 begins to fill. When the threshold pressure on the triangular region 14 is exceeded, the bladder 10 begins to contract and drains the collected urine through the urethra 12.

As shown in FIGS. 27 and 28, the distal portion of the ureteral catheter is deployed within the renal pelvis 20, 21 in the vicinity of kidneys 2, 4. The proximal portion of one or more of the catheters 1212 is connected to the single outflow port 2002 of the fluid pump 2000 through the Y-connector 2010 and the tube set 2050. An exemplary Y-connector 2010 and a tube set 2020 connected to it are shown in FIGS. 36 and 37. The Y-connector 2010 comprises a tubular body 2012 made of a rigid plastic material, the body 2012 comprising two inflow ports 2014, 2016 and a one-way check valve 2018 to prevent backflow. It has an outflow port. The inflow ports 2014, 2016 may include a luer locking connector for receiving the proximal end of the catheter 1212, a threaded connector, or a connector portion 2020 such as a similar mechanism known in the art. As shown in FIG. 37, the proximal end of the catheter 1212 has a corresponding structure for mounting on the Y-connector 2010. The tubing set 2050 extends between the one-way check valve 2018 of the Y-connector 2010 and the funnel-shaped connector 2054 configured to engage the outflow port 2002 of the fluid pump 2000. A length flexible medical tube 2052 is provided. The shape and size of the funnel-shaped connector 2054 can be selected based on the type of pump 2000 used. In some embodiments, the funnel-shaped connector 2054 can only be connected to a particular pump type, which is considered safe for inducing negative pressure in the patient's bladder, ureter, or kidney. , Can be manufactured with a unique configuration. In another embodiment, as described herein, the connector 2054 can be a more versatile configuration adapted for mounting on a variety of different types of fluid pumps.

System 1100 is just one embodiment of a negative pressure system for inducing negative pressure that can be used in conjunction with the ureteral catheter 1212 disclosed herein. Other systems and urine collection assemblies that can be used with the catheter 1212 are shown, for example, in FIGS. 1, 9A, 10A, 11A, and 19. In addition, the catheter 1212 can be connected to a separate negative pressure source. In another embodiment, one or more catheters 1212 can be connected to a negative pressure source, while the other catheter 1212 can be connected to a non-pressurized fluid collection vessel.

Additional Illustrative Urine Catheter As shown in FIG. 1, a urine collection assembly 100 is illustrated that includes ureteral catheters 112, 114 configured to be positioned within the patient's urethra. For example, the distal ends 120, 121 of the ureteral catheters 112, 114 may be configured to deploy within the patient's ureters 2, 4, especially within the renal pelvis 20, 21 area of the kidneys 6, 8. it can.

In some embodiments, the urine collection assembly 100 is located within or adjacent to the renal pelvis 20 of the right kidney 2 and the first catheter 112 and adjacent to the renal pelvis 21 of the left kidney 4. Two separate ureteral catheters, such as two catheters 114, can be provided. Catheter 112, 114 can be separate for their entire length, or are held in close proximity to each other by clips, rings, clamps, or other types of connecting mechanisms (eg, connector 150). The placement or removal of 114 can be facilitated. In some embodiments, catheters 112, 114 can be fused or connected together to form a single drainage lumen. In another embodiment, the catheters 112, 114 are inserted or encapsulated through another catheter, tube, or sheath along a portion or compartment thereof, and the catheters 112, 114 are inserted into the body. And can facilitate a retreat from it. For example, the bladder catheter 116 is inserted across and / or along the same guide wire as the ureteral catheters 112, 114, thereby extending the ureteral catheters 112, 114 from the distal end of the bladder catheter 116. Can be done.

With reference to FIGS. 1, 2A, and 2B, the exemplary ureteral catheter 112 may comprise at least one extension body or tube 122, within which one or more drainage channels, such as drainage lumen 124, or Define or construct a lumen. Tube 122 sizes can range from about 1 French to about 9 French (French catheter scale). In some embodiments, the tube 122 can have an outer diameter ranging from about 0.33 to about 3 mm and an inner diameter ranging from about 0.165 to about 2.39 mm. In one embodiment, the tube 122 is 6 French and has an outer diameter of 2.0 ± 0.1 mm. The length of the tube 122 can range from about 30 cm to about 120 cm, depending on the patient's age (eg, child or adult) and gender.

The tube 122 is formed from a flexible and / or deformable material and can facilitate the advancement and / or positioning of the tube 122 within the bladder 10 and the ureters 6 and 8 (shown in FIG. 1). The catheter material should be flexible and soft enough to avoid or reduce inflammation of the renal pelvis and ureter, but when the renal pelvis or other part of the urethra applies pressure to the outside of the tube 122. , Or when the renal pelvis and / or ureter is towed against the tube 122 during the induction of negative pressure, the tube 122 should be sufficiently rigid to prevent crushing. For example, the tube 122 can be formed from a material comprising a biocompatible polymer, polyvinyl chloride, polytetrafluoroethylene (PTFE) such as Teflon (R), silicone coated latex, or silicone. In one embodiment, the tube 122 is made of thermoplastic polyurethane. At least some or all of the catheter 112, such as the tube 122, can be coated with a hydrophilic coating to facilitate insertion and / or removal and / or improve comfort. In some examples, the coating is a hydrophobic and / or lubricious coating. For example, a suitable coating is Koninklijke DSM N. et al. V. Combining a ComfortCoat (R) hydrophilic coating available from, or a hydrophilic coating comprising a polymeric electrolyte as disclosed in US Pat. No. 8,512,795 (incorporated herein by reference). be able to.

In some embodiments, the tube 122 has a distal portion 118 (eg, a portion of the tube 122 configured to be located within the ureters 6, 8 and the bladder 20, 21) and a central portion 126 (eg, the central portion 126). , A portion of the tube 122 configured to extend from the distal portion through the ureteral opening 16 into the patient's bladder 10 and urethra 12 and a proximal portion 128 (eg, external fluid collection from the urethra 12). A portion of tube 122) that extends to the container and / or pump assembly can be provided. In one preferred embodiment, the combined length of the proximal portion 128 and the central portion 126 of the tube 122 is about 54 ± 2 cm. In some embodiments, the tube 122 terminates in another indwelling catheter and / or in the drain lumen, such as in the drain lumen of the bladder catheter 116. In that case, the fluid is drained from the proximal ends of the ureteral catheters 112, 114 and directed from the body through the additional indwelling catheter and / or drainage lumen.

Additional exemplary ureteral retention part:
Continuing with reference to FIGS. 1, 2A, and 2B, the distal portion 118 of the ureteral catheter 112 has the distal end 120 of the catheter 112 in close proximity to or in the renal pelvis 20, 21 of the kidneys 2, 4. A retention portion 130 is provided for maintaining the desired fluid collection position of the. In some embodiments, the retention portion 130 is configured to be flexible and flexible to allow the retention portion 130 to be positioned within the ureter and / or renal pelvis. The retention portion 130 is preferably flexible enough to absorb the force exerted on the catheter 112 and prevent such force from being transmitted to the ureter. For example, if the retention portion 130 is pulled towards the patient's bladder in the proximal direction P (shown in FIG. 3A), the retention portion 130 begins to unwind or straighten so that it can be pulled through the ureter. Can be flexible enough for. Similarly, when the retention portion 130 can be reinserted into the renal pelvis or other suitable area within the urinary tract, it can be urged to return to its unfolded configuration.

In some embodiments, the retention portion 130 is integral with the tube 122. In that case, the retention portion 130 can be formed by applying a bend or curl to the catheter body 122, which is sized and shaped to retain the catheter in the desired fluid collection location. Suitable bends or coils can include pigtail coils, corkscrew coils, and / or spiral coils. For example, the retention portion 130 is configured to passively retain the catheter 112 in the ureters 6 and 8 in close proximity to or in contact with the renal pelvis 20 and 21 in one or more radial directions. And a spiral coil extending in the vertical direction can be provided. In another embodiment, the retention portion 130 is formed from a radially flared or tapered portion of the catheter body 122. For example, the retention portion 130 can further include a fluid collection portion as shown in FIGS. 4A and 4B, such as a tapered or funnel-shaped inner surface 186. In another embodiment, the retention portion 130 can comprise a separate element that is connected to and extends from the catheter body or tube 122.

The retention portion 130 may further include one or more perforation compartments such as a drain opening or a port 132 (eg, shown in FIG. 3A-3E). The drain port can be located, for example, at the open distal ends 120, 121 of the tube 122. In another embodiment, the perforation compartment and / or drain port 132 is located along the side wall of the distal portion 118 of the catheter tube 122. The drain port or hole can be used to assist fluid collection. In another embodiment, the retention portion 130 is dedicated to the storage structure and fluid collection, and / or the application of negative pressure is provided by the structure elsewhere on the catheter tube 122.

With reference to FIGS. 2A, 2B, and 3A-3E, an exemplary retention portion 130 comprising a plurality of spiral coils, such as one or more complete coils 184 and one or more half or partial coils 183, is illustrated. The retention portion 130, along with the plurality of spiral coils, is movable between the contraction position and the deployment position. For example, a substantially straight guide wire can be inserted through the retention portion 130 to maintain the retention portion 130 in a substantially linear contraction position. When the guide wire is removed, the retaining portion 130 can transition to its coiled configuration. In some embodiments, the coils 183, 184 extend radially and longitudinally from the distal portion 118 of the tube 122. Specifically referring to FIGS. 2A and 2B, in a preferred exemplary embodiment, the retention portion 130 comprises two complete coils 184 and a half coil 183. The outer diameter of the complete coil 184 represented by line D1 can be about 18 ± 2 mm. The diameter D2 of the half coil 183 can be about 14 mm. The coiled retaining portion 130 has a height H of about 16 ± 2 mm. The retention portion 130 may further include one or more drain holes 132 (eg, shown in FIG. 3A-3E) configured to draw fluid into the interior of the catheter tube 122. In some embodiments, the retention portion 130 may be provided with an additional hole at the distal tip 120 of the retention portion, in addition to the six drain holes. The diameter of each of the discharge holes 132 (eg, shown in FIG. 3A-3E) can range from about 0.7 mm to 0.9 mm, preferably about 0.83 ± 0.01 mm. The distance between adjacent discharge holes 132, specifically, the linear distance between the discharge holes 132 when the coil is straightened, can be about 22.5 ± 2.5 mm.

As shown in FIG. 3A-3E, in another exemplary embodiment, the distal portion 118 of the drainage lumen proximal to the retention portion 130 defines a straight or curved central axis L. In some embodiments, at least half or the first coil 183 and complete or second coil 184 of the retention portion 130 extend about axis A of the retention portion 130. The first coil 183 starts or rises from the point where the tube 122 bends at an angle α ranging from about 15 degrees to about 75 degrees, preferably about 45 degrees, from the central axis L, as indicated by the angle α. Start. As shown in FIGS. 3A and 3B, the axis A can be co-extended with the longitudinal central axis L prior to insertion into the body. In another embodiment, as shown in FIG. 3C-3E, the axis A extends from the central vertical axis L prior to insertion into the body, eg, curved or angled at an angle β with respect to it. Be done.

In some embodiments, the plurality of coils 184 can have the same inner diameter and / or outer diameter D and height H2. In that case, the outer diameter D1 of the coil 184 may range from 10 mm to 30 mm. The height H2 between the coils 184 may be about 3 mm to 10 mm.

In another embodiment, the retention portion 130 is configured to be inserted into the tapered portion of the renal pelvis. For example, the outer diameter D1 of the coil 184 can increase towards the distal end 120 of the tube 122 to provide a helical structure with a tapered or partially tapered configuration. For example, the distal or maximum outer diameter D1 of the tapered spiral portion ranges from about 10 mm to about 30 mm and corresponds to the size of the renal pelvis. The height H2 of the retention portion 130 ranges from about 10 mm to about 30 mm.

In some embodiments, the outer diameter D1 and / or height H2 of the coil 184 can vary in a regular or irregular manner. For example, the outer diameter D1 of the coils or the height H2 between the coils can be increased or decreased by regular amounts (eg, about 10% to about 25% between adjacent coils 184). For example, with respect to the retention portion 130 having three coils (eg, as shown in FIGS. 3A and 3B), the outer diameter D3 of the nearest coil or the first coil 183 can be about 6 mm to 18 mm. The outer diameter D2 of the central coil or the second coil 185 can be from about 8 mm to about 24 mm, and the outer diameter D1 of the most distal or third coil 187 can be from about 10 mm to about 30 mm. ..

The retention portion 130 further comprises a drain port 132 or a hole that is located on or through the side wall of the catheter tube 122 on or adjacent to the retention portion 130 so that urine waste is discharged from the outside of the catheter tube 122. It can be allowed to flow inside the. The position and size of the discharge port 132 can vary depending on the desired flow rate and configuration of the retention portion. The diameter of the discharge port 132 can range from about 0.005 mm to about 1.0 mm. The spacing between the discharge ports 132 can range from about 1.5 mm to about 25 mm. The discharge ports 132 can be spaced apart in any arrangement, eg, linearly or offset. In some embodiments, the discharge port 132 can be non-circular and can have an area of approximately 0.002 to 0.79 mm ² .

In some embodiments, as shown in FIG. 3A, the drain port 132 is located around the entire perimeter of the side wall of the catheter tube 122, increasing the amount of fluid that can be drawn into the drain lumen 124. (Shown in FIGS. 1, 2A, and 2B). In another embodiment, as shown in FIG. 3B-3E, the discharge port 132 is essentially located only on or only on the radial inward facing side of the coil 184 to block the discharge port 132. Alternatively, interference can be prevented and the outward facing side of the coil may essentially have no discharge port 132 or no discharge port 132. For example, when negative pressure is induced in the ureter and / or renal pelvis, the mucosal tissue of the ureter and / or kidney can be towed against the retention portion 130, some on the lateral periphery of the retention portion 130. Can block the discharge port 132 of. The discharge port 132, located on the radial inward side of the reservoir structure, will not be significantly blocked when such tissue contacts the outer periphery of the retention portion 130. In addition, the risk of tissue injury from biting or contact with the discharge port 132 can be reduced or ameliorated.

With reference to FIGS. 3C and 3D, another embodiment of the ureteral catheter 112 having a retention portion 130 with a plurality of coils is illustrated. As shown in FIG. 3C, the retention portion 130 includes three coils 184 extending about the axis A. The axis A is a curved arc extending from the central vertical axis L of a part of the discharge lumen 181 proximal to the retention portion 130. The curvature imparted to the retention portion 130 can be selected to correspond to the curvature of the renal pelvis, which comprises a Cornucopia-shaped cavity.

As shown in FIG. 3D, in another exemplary embodiment, the retention portion 130 may include two coils 184 extending about an angled axis A. The angled axis A extends at an angle from the central vertical axis L and is angled with respect to an axis substantially perpendicular to the central axis L of a portion of the drainage lumen, as indicated by the angle β. The angle β can range from about 15 to about 75 degrees (eg, about 105 to about 165 degrees with respect to the central vertical axis L of the drainage lumen portion of the catheter 112).

FIG. 3E shows another embodiment of the ureteral catheter 112. The retention portion comprises three spiral coils 184 extending about the axis A. The axis A is angled with respect to the horizontal, as indicated by the angle β. As in the previous embodiment, the angle β can range from about 15 to about 75 degrees (eg, about 105 to about 165 degrees with respect to the central longitudinal axis L of the drainage lumen portion of the catheter 112).

With reference to FIGS. 4A and 4B, in another example, the retention portion 130 of the ureteral catheter 112 is configured to be positioned within the patient's renal pelvis and / or kidney in some examples. / Or a catheter tube 122 having a tapered distal end portion. For example, the retention portion 130 comprises an outer surface 185 configured to be positioned relative to the ureter and / or kidney wall, and an inner configured to direct fluid towards the drainage lumen 124 of the catheter 112. It can be a funnel-shaped structure with a surface 186. The retention portion 130 is adjacent to the distal end of the drain lumen 124 and has a first diameter D1 and a proximal end 188, which is larger than the first diameter D1 when the retention portion 130 is in its unfolded position. It can be provided with a distal end 190 having a second diameter D2. In some embodiments, the retention portion 130 is capable of transitioning from a crushed or compressed position to an expanded position. For example, the retention portion 130 is attached radially outward so that when the retention portion 130 is advanced to its fluid collection position, the retention portion 130 (eg, the funnel portion) expands radially outwardly. Can be forced.

The retention portion 130 of the ureteral catheter 112 can be made of a variety of suitable materials capable of transitioning from a crushed state to a deployed state. In one embodiment, the retention portion 130 comprises a framework of forked or elongated members formed from a temperature sensitive shape memory material such as nitinol. In some embodiments, the nitinol frame can be coated with a suitable waterproof material such as silicone to form a tapered portion or funnel. In that case, the fluid is allowed to flow into the drain lumen 124 following the inner surface 186 of the retention portion 130. In another embodiment, the retaining portion 130 is formed from various rigid or partially rigid sheets or materials that are bent or molded to form a funnel-shaped retaining portion, as illustrated in FIGS. 4A and 4B. Will be done.

In some embodiments, the retention portion of the ureteral catheter 112 may include one or more mechanical stimulation devices 191 for providing stimulation to nerves and muscle fibers in adjacent tissues of the ureter and renal pelvis. it can. For example, the mechanical stimulus device 191 may include a linear or annular actuator that is embedded in or adjacent to a portion of the side wall of the catheter tube 122 and is configured to emit low levels of vibration. it can. In some examples, mechanical stimulation is provided to the ureter and / or part of the renal pelvis and can complement or modify the therapeutic effect obtained by applying negative pressure. Although not intended to be constrained by theory, such stimuli to adjacent tissues, for example, by stimulating the nerves associated with the ureter and / or renal pelvis and / or activating the peristaltic muscles. It is thought to have an effect. Nerve stimulation and muscle activation can result in changes in pressure gradients or pressure levels within surrounding tissues and organs, which contribute to, or in some cases, the therapeutic benefits of negative pressure therapy. Can be improved.

With reference to FIGS. 5A and 5B, according to another embodiment, the retention portion 330 of the ureteral catheter 312 is formed within the helical structure 332 and the inflatable element or balloon 350 located proximal to the helical structure 332 and is in the renal pelvis. And / or a catheter tube 322 having a distal portion 318 to provide additional retention within the fluid collection site. The balloon 350 is sufficient to retain the balloon in the renal pelvis or urinary tract, but can be inflated to a pressure low enough to avoid swelling or damage to these structures. Suitable expansion pressures are known to those skilled in the art and can be easily determined by trial and error. As in the above embodiment, the helical structure 332 can be imparted by bending the catheter tube 322 to form one or more coils 334. The coil 334 can have a constant or variable diameter and height, as described above. The catheter tube 322 is further located on the side wall of the catheter tube 322 and urine is drawn into the drainage lumen 324 of the catheter tube 322, eg, inwardly facing and / or outwardly facing the coil 334. It comprises a plurality of drain ports 336 that allow it to be directed from the body through the drain lumen 324 on the side it was.

As shown in FIG. 5B, the inflatable element or balloon 350 can include, for example, an annular balloon-like structure having a substantially heart-shaped cross section and comprising a surface or cover 352 defining a cavity 353. The cavity 353 fluidly communicates with an inflatable lumen 354 extending parallel to the drainage lumen 324 defined by the catheter tube 322. The balloon 350 can be inserted into the tapered portion of the renal pelvis and configured to inflate such that its outer surface 356 contacts and rests against the ureter and / or the inner surface of the renal pelvis. .. The inflatable element or balloon 350 can include a tapered inner surface 358 extending longitudinally and radially inwardly toward the catheter tube 322. The medial surface 358 can be configured to direct urine towards the catheter tube 322 so that it is drawn into the drainage lumen 324. The inner surface 358 can also be positioned to prevent fluid from accumulating in the urinary tract, such as around the inflatable element or the periphery of the balloon 350. The inflatable retaining portion or balloon 350 is preferably sized to fit within the renal pelvis and can have a diameter ranging from about 10 mm to about 30 mm.

With reference to FIGS. 6 and 7, in some embodiments, an assembly 400 including a ureteral catheter 412 with a retention portion 410 is illustrated. The retention portion 410 is formed of a porous and / or spongy material attached to the distal end 421 of the catheter tube 422. The porous material can be configured to carry and / or absorb urine and direct urine towards the drain lumen 424 of the catheter tube 422. As shown in FIG. 7, the retention portion 410 can be a porous wedge-shaped structure configured for insertion and retention in the patient's renal pelvis. The porous material comprises multiple openings and / or channels. The fluid can be drawn through the channels and openings, for example by gravity or in response to the induction of negative pressure through the catheter 412. For example, fluid can enter the wedge-shaped retention section 410 through the openings and / or channels, for example by capillarity, peristalsis, or as a result of the induction of negative pressure within the openings and / or channels. , Pulled out towards the distal opening 420 of the drainage lumen 424. In another embodiment, as shown in FIG. 7, the retention portion 410 comprises a hollow funnel structure formed from a porous sponge-like material. As indicated by arrow A, the fluid follows the inner surface 426 of the funnel structure and is directed into the drain lumen 424 defined by the catheter tube 422. The fluid can also enter the funnel structure of retention portion 410 through openings and channels within the porous sponge-like material of the side wall 428. For example, suitable porous materials can include open cell polyurethane foams such as polyurethane ethers. Suitable porous materials are also with or without antibacterial additives such as silver and with or without additives for modifying material properties such as hydrogels, hydrophilic colloids, acrylics, or silicones. Without accompanying, it can include a laminate of layers of woven or non-woven fabric, including, for example, polyurethane, silicone, polyvinyl alcohol, cotton, or polyester.

Referring to FIG. 8, according to another embodiment, the retention portion 500 of the ureteral catheter 512 comprises an expandable cage 530. The expandable cage 530 includes one or more longitudinal and radial hollow tubes 522. For example, tube 522 can be formed from an elastic shape memory material such as nitinol. The cage 530 is configured to transition from a contracted state for insertion through the patient's urethra to an expanded state for positioning within the patient's ureter and / or kidney. The hollow tube 522 includes a plurality of discharge ports 534 that can be located on the tube, eg, its radial inward facing side. Port 534 is configured to allow fluid to flow or be drawn through the port 534 into a separate tube 522. The fluid is drained through the hollow tube 522 into the drain lumen 524 defined by the catheter body 526 of the ureteral catheter 512. For example, the fluid can flow along the path indicated by arrow 532 in FIG. In some embodiments, when negative pressure is induced in the renal pelvis, kidney, and / or ureter, the ureteral wall and / or part of the renal pelvis is directed against the outwardly facing surface of the hollow tube 522. Can be towed. The drain port 534 is positioned and configured so that it is not significantly obstructed by the ureteral structure in response to the application of negative pressure to the ureter and / or kidney.

Illustrative urine collection assembly:
With reference to FIGS. 1, 9A, and 11A, in some embodiments, the urine collection assembly 100 can further include a bladder catheter 116. The distal ends 120, 121 of the ureteral catheters 112, 114 can be connected to the bladder catheter 116 to provide a single drainage lumen for urine, or the ureteral catheter is via a separate tube. , Can be drained from the bladder catheter 116.

Illustrative Bladder Catheter The bladder catheter 116 provides mooring, retention, and / or passive fixation for the indwelling portion of the urine collection assembly 100, and in some embodiments, early and / or early assembly components during use. Alternatively, it is provided with a deployable seal and / or anchor 136 to prevent unintended removal. The anchor 136 is located adjacent to the inferior wall of the patient's bladder 10 (shown in FIG. 1) and the force applied to the patient movement and / or indwelling catheters 112, 114, 116 is transmitted to the ureter. Is configured to prevent. The bladder catheter 116 comprises an interior defining a drainage lumen 140 configured to conduct urine from the bladder 10 to an external urine collection vessel 712 (shown in FIG. 19). In some embodiments, the size of the bladder catheter 116 can range from about 8 French to about 24 French. In some embodiments, the bladder catheter 116 can have an outer diameter ranging from about 2.7 to about 8 mm. In some embodiments, the bladder catheter 116 can have an inner diameter ranging from about 2.16 to about 6.2 mm. The bladder catheter 116 may be available in different lengths to accommodate anatomical differences for gender and / or patient size. For example, the average female urethral length is only a few inches, so the length of the tube 138 can be quite short. The average urethral length in men is longer and can vary due to the penis. It is also possible for women to use a bladder catheter 116 with a longer length tube 138, provided that excess tubing does not increase the difficulty in operating the catheter 116 and / or preventing contamination of its sterile portion. Considered as sex. In some examples, the sterile and indwelling portion of the bladder catheter 116 can range from about 1 inch to 3 inches (female) to about 20 inches (male). The overall length of the bladder catheter 116, including sterile and non-sterile parts, can be one to several feet.

Catheter tube 138 can include one or more drain ports 142 configured to be positioned within the bladder 10 to draw urine into the drain lumen 140. For example, excess urine remaining in the patient's bladder 10 during installation of the ureteral catheters 112, 114 is drained from the bladder 10 through the port 142 and the drainage lumen 140. In addition, any urine that is not collected by the ureteral catheters 112, 114 can accumulate in the bladder 10 and be carried from the urethra through the drainage lumen 140. The drain lumen 140 may be pressurized to negative pressure to assist fluid collection, or to atmospheric pressure so that fluid is collected by gravity and / or as a result of partial contraction of the bladder 10. May be maintained. 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 the insertion and placement of the ureteral catheters 112, 114.

Specifically referring to FIG. 1, a deployable seal and / or anchor 136 is placed at or adjacent to the distal end 148 of the bladder catheter 116. The deployable anchor 136 is configured to transition between a contracted state for insertion into the bladder 10 through the urethra 12 and the urethral opening 18 and a deployed state. Anchor 136 is configured to deploy and sit within or adjacent to the lower portion of the bladder 10 and / or with respect to the urethral opening 18. For example, the anchor 136 is positioned adjacent to the urethral opening 18 to improve the suction of negative pressure applied to the bladder 10, or to partially, substantially, the bladder 10 in the absence of negative pressure. Alternatively, it can be completely sealed to ensure that urine in the bladder 10 is directed through the drainage lumen 140 and prevent leakage into the urethra 12. With respect to the bladder catheter 116, which includes an extension tube 138 of 8 French to 24 French, the anchor 136, in the unfolded state, is about 12 French to 32 French (eg, has a diameter of about 4 mm to about 10.7 mm), preferably. It can be from about 24 French to 30 French. The 24 French anchor has a diameter of about 8 mm. It is believed that the 24 French anchor 136 will be a suitable single size for all or most patients. For the catheter 116 with the 24 French anchor 136, the suitable length of the anchor 136 is about 1.0 cm to 2.3 cm, preferably about 1.9 cm (about 0.75 inch).

Illustrative Bladder Anchor Structure With specific reference to FIGS. 1, 12A, and 13, exemplary bladder anchor 136 in the form of an expandable balloon 144 is illustrated. The inflatable (eg, inflatable) balloon 144 can be, for example, a spherical balloon of a Foley catheter. The balloon 144 can have a diameter of about 1.0 cm to 2.3 cm, preferably about 1.9 cm (0.75 inches) in diameter. The balloon 144 is preferably formed from a flexible material, including, for example, a biocompatible polymer, polyvinyl chloride, polytetrafluoroethylene (PTFE) such as Teflon (R), silicone coated latex, or silicone. To.

The balloon 144 is fluidly connected to the inflatable lumen 146 and inflated by introducing the fluid into the balloon 144. In the unfolded state, the balloon 144 is mounted on the catheter tube 138 of the bladder catheter 116, extending radially outward from there, and having a central cavity or channel through which the catheter tube 138 passes, a substantially spherical structure Can be. In some embodiments, the catheter tube 138 has an open distal end 148 of the catheter tube 138 extending distally beyond the balloon 144 and towards the center of the bladder 10 (shown in FIG. 1). As such, it extends through the cavity defined by the balloon 144. Excess urine collected in the bladder 10 can be drawn into the drain lumen 140 through its distal open end 148.

As shown in FIGS. 1 and 12A, in one embodiment, the ureteral catheters 112, 114 extend from the open distal end 148 of the drain lumen 140. In another embodiment, as shown in FIG. 14, the ureteral catheters 112, 114 extend through a port 172 or opening, which is located on the side wall of the catheter tube 138 at a position distal to the balloon 144. .. Port 172 can be circular or oval in shape. The port 172 is sized to receive the ureteral catheters 112, 114 and can therefore have a diameter ranging from about 0.33 mm to about 3 mm. As shown in FIG. 13, in another embodiment, the bladder catheter 116 is positioned next to the balloon 144 rather than extending through the central cavity defined by the balloon 144. As in other examples, the ureteral catheters 112, 114 extend into the bladder 10 through port 172 in the side wall of the bladder catheter 116.

With reference to FIG. 12B, cross-sectional views of the bladder catheter 116 and the ureteral catheters 112, 114 are shown. As shown in FIG. 12B, in one embodiment, the bladder catheter 116 involves a drainage lumen 140 in its central region and a smaller inflatable lumen 146 extending along the periphery of the catheter tube 138. , Equipped with a double luminal catheter. The ureteral catheters 112 and 114 are inserted or encapsulated within the central drainage lumen 140. The ureteral catheters 112, 114 are single lumen catheters having a cross section narrow enough to fit within the drainage lumen 140. In some examples, as discussed above, the ureteral catheters 112, 114 extend throughout the bladder catheter 116. In another embodiment, the ureteral catheters 112, 114 terminate within the drainage lumen 140 of the bladder catheter 116, either at some location within the patient's ureteral 12 or within the outer portion of the drainage lumen 140. As shown in FIG. 12C, in another embodiment, the bladder catheter 116a is a first for carrying fluid from at least four lumens, i.e. the first ureteral catheter 112 (shown in FIG. 1). 112a, a second lumen 114a for carrying fluid from a second ureteral catheter 114 (shown in FIG. 1), and drainage of urine from the bladder 10 (shown in FIG. 1). A multi-cavity catheter that defines a third lumen 140a for and, for its expansion and retreat, an expansion lumen 146a for carrying fluid to and from balloon 144 (shown in FIG. 12A). is there.

As shown in FIG. 15, another embodiment of the catheter balloon 144 for use with the urine collection assembly 100 is illustrated. In the embodiment of FIG. 15, the balloon 144 is located partially within the patient's bladder 10 and partially within the urethra 12 and is configured to provide an improved bladder seal. The central portion 145 of the balloon 144 is radially contracted by the urethral opening 18 to a bulbous upper volume and a distal portion of the urethra 12 configured to be positioned in the lower portion of the bladder 10. It is configured to define a bulbous lower volume that is configured to be positioned. As in the previous embodiment, the bladder catheter 116 extends through the central cavity defined by the balloon 144 towards the central portion of the bladder 10 and carries urine from the bladder 10 through the drainage lumen 140 of the catheter 116. Includes discharge port 142. The discharge port 142 can be substantially circular or oval in shape and can have a diameter of about 0.005 mm to about 8 mm.

With reference to FIGS. 9A and 9B again, another embodiment of the urine collection assembly 100, including the bladder anchor device 134, is illustrated. The bladder anchor device 134 comprises a drain lumen 140, an inflatable lumen 146, and another embodiment of an expandable balloon 144 configured to sit within the anchor 136, the lower portion of the bladder 10. A defining bladder catheter 116 is provided. Unlike the embodiments described above, the port 142, configured to receive the ureteral catheters 112, 114, is located proximal and / or below the balloon 144. The ureteral catheters 112, 114 extend from the port 142 and into the ureter through the ureteral ostium or opening of the bladder, as in the previous embodiment. When the anchor 136 is deployed within the bladder, the port 142 is located within the lower portion of the bladder adjacent to the urethral opening. Ureteral catheters 112, 114 extend from port 172 between the lower portion of the balloon 144 and the bladder wall. In some embodiments, catheters 112, 114 have a balloon 144 and / or bladder wall at port 142 so that excess urine collected in the bladder can be drawn into port 142 and removed from the body. May be positioned to prevent obstruction.

With reference to FIGS. 10A and 10B again, in another embodiment of the urine collection assembly 200, the expandable cage 210 is anchored to the assembly 200 in the bladder. The expandable cage 210 comprises a plurality of flexible members 212 or apex extending longitudinally and radially outwardly from the catheter body 238 of the bladder catheter 216, which in some embodiments, FIG. Can be similar to those described above with respect to the retention portion of the ureteral catheter. The member 212 can be formed from a suitable elastic and shape memory material such as nitinol. In the unfolded position, the member 212 or apex is provided with sufficient curvature to define the spherical or ellipsoidal central cavity 242. The cage 210 is attached to the open distal open end 248 of the catheter tube or body 238 and allows access to the drain lumen 240 defined by the tube or body 238. The cage 210 is sized for positioning within the lower portion of the bladder and may define a diameter and length ranging from 1.0 cm to 2.3 cm, preferably about 1.9 cm (0.75 inches). it can.

In some embodiments, the cage 210 further comprises a shield or cover 214 over the distal portion of the cage 210, and the tissue, i.e. the distal wall of the bladder, is captured as a result of contact with the cage 210 or member 212. Or prevent or reduce the possibility of being bitten. More specifically, as the bladder contracts, the medial distal wall of the bladder contacts the distal side of the cage 210. Cover 214 may prevent tissue from being bitten or trapped, reduce patient discomfort during use, and protect the device. The cover 214 can be formed, at least in part, from a porous and / or permeable biocompatible material such as a woven polymer mesh. In some embodiments, the cover 214 surrounds all or substantially all of the cavity 242. In that case, the cover 214 defines a suitable opening for removing the ureteral catheters 112, 114. In some embodiments, the cover 214 covers only about two-thirds, about half, or about one-third of the distal portion of the cage 210, or any amount. In that case, the ureteral catheters 112, 114 pass through the uncovered portion of the cage 210.

The cage 210 and cover 214 can transition from a contracted position to a deployed position where the member 212 is tightly contracted both around the central portion and / or around the bladder catheter 116, allowing insertion through the catheter or sheath. Is. For example, in the case of a cage 210 constructed from shape memory material, the cage 210 can be configured to transition to a deployment position when heated to a sufficient temperature such as body temperature (eg, 37 ° C.). .. In the deployed position, the cage 210 preferably provides support for the ureteral catheters 112, 114 and prevents patient movement from being transmitted to the ureter through the ureteral catheters 112, 114. Has a diameter D, wider than the ureteral opening. When the assembly 200 is deployed in the urethra, the ureteral catheters 112, 114 extend into the bladder from the open distal end 248 of the bladder catheter 216 beyond the longitudinally extending member 212 of the cage 210. Extends to. Advantageously, the open (eg, thin) arrangement of the member 212 or the apex facilitates the operation of the ureteral catheters 112, 114 from the bladder catheter 116 through the bladder. In particular, the open arrangement of the members 212 or apex does not interfere with or obstruct the distal opening 248 and / or drain port of the bladder catheter 216, making it easier to operate the catheters 112, 114.

With reference to FIG. 16, some of the other embodiments of the urine collection assembly 100b are illustrated. The urine collection assembly 100b includes a first ureteral catheter 112b and a second ureteral catheter 114b. Assembly 100b does not include a separate bladder drainage catheter as provided in the previous embodiment. Instead, one of the ureteral catheters 112b is a spiral formed within the central portion of the catheter 112b (eg, a portion of the catheter configured to be located within the lower portion of the patient's bladder). A portion 127b is provided. The spiral portion 127b comprises at least one, preferably two or more coils 176b. The coil 176b can be formed by bending the catheter tube 138b to impart the desired coil configuration. The lower coil 178b of the spiral portion 127b is configured to be seated with respect to and / or adjacent to the urethral opening. Desirably, the spiral portion 127b has a diameter D that is larger than the urethral opening and prevents the spiral portion 127b from being pulled into the urethra. In some embodiments, the port 142b or opening is located within the side wall of the catheter tube 138b to connect the first ureteral catheter 112b to the second ureteral catheter 114b. For example, the second catheter 114b can be inserted into the port 142b to form a fluid connection between the first ureteral catheter 112b and the second ureteral catheter 114b. In some embodiments, the second catheter 114b terminates at a position just inside the drain lumen 140b of the first catheter 112b. In another embodiment, the second ureteral catheter 114b is screwed through the drainage lumen 140b of the first catheter 112b and / or extends along its length, but with the drainage lumen 140b and fluid. Do not communicate.

With reference to FIGS. 11A and 11B again, another exemplary urine collection assembly 100 with a bladder anchor device 134 is illustrated. Assembly 100 includes ureteral catheters 112, 114 and a separate bladder catheter 116. More specifically, as in the previous embodiment, assembly 100 includes a ureteral catheter 112, 114, a distal portion 118, which is located within or adjacent to each of the right and left kidneys, respectively. Be prepared. Ureteral catheters 112, 114 include indwelling portions 118, 126, 128 extending through the ureter, bladder, and urethra. The ureteral catheters 112, 114 further comprise an external portion 170 extending from the patient's urethra 12 to a pump assembly for applying negative pressure to the renal pelvis and / or kidney. Assembly 100 is also deployed with the bladder catheter 116 and an anchor 136 (eg, Foley catheter) that is deployed within the bladder to prevent or reduce the effects of patient movement being transmitted to the ureteral catheters 112, 114 and / or the ureter. ), The bladder anchor device 134 is included. The bladder catheter 116 extends from the bladder 10 through the urethra to a fluid collection vessel for fluid collection by gravity or negative pressure drainage. In some embodiments, the outer portion of the tube, extending between the collection vessel 712 and the pump 710 (shown in FIG. 19), is to prevent urine and / or fine particles from entering the pump. Can include one or more filters of. As in the previous embodiment, the bladder catheter 116 is provided to drain excess urine left in the patient's bladder during catheter placement.

Illustrative connectors and clamps:
With reference to FIGS. 1, 11A, and 17A-17C, assembly 100 further comprises a manifold or connector 150 for joining two or more of catheters 112, 114, 116 at positions outside the patient's body. .. In some embodiments, the connector 150 is a clamp, manifold, valve, fastener, or other element of a fluid path set as known in the art for joining a catheter to an external flexible tubing. Can be. As shown in FIGS. 17A and 17B, the manifold or connector 150 comprises a two-part body comprising an inner portion 151 mounted inside the outer housing 153. The inner portion 151 defines a channel for carrying fluid between inflow ports 154 and 155 and outflow ports 158. Inflow ports 154 and 155 can include threaded sockets 157 configured to receive proximal portions of catheters 112 and 114. Desirably, the socket 157 is a suitable size for anchoring, receiving and holding flexible tubing sized from 1 French to 9 French. Generally, the user anchors the socket 157 around a separate catheter tube 122 by spinning the socket 157 into ports 154 and 155 in the direction of arrow A1 (shown in FIG. 17B).

Once the catheters 112, 114 are mounted on the connector 150, they enter the connector 150 through the vacuum inflow ports 154 and 155, urine evacuates through the fluid conduit in the direction of arrow A2 (shown in FIG. 17B). Directed to port 158. The vacuum outflow port 158 can be connected to the fluid collection vessel 712 and / or the pump assembly 710 (shown in FIG. 19), for example, by flexible tubing 166 defining the fluid flow path.

With specific reference to FIG. 17C, another exemplary connector 150 can be configured to connect three or more catheters 112, 114, 116 to outflow ports 158, 162. The connector 150 is configured to connect to two or more vacuum inflow ports 154 and 155 configured to connect to the proximal ends of the ureteral catheters 112 and 114 and to the proximal ends of the bladder catheter 116. Can include a structure or body having a distal side 152, with a separate gravity discharge port 156. Vacuum ports 154, 155 and / or proximal ends of ureteral catheters 112, 114 to ensure that ureteral catheters 112, 114 are connected to a vacuum source rather than some other fluid collection assembly. A specific configuration can be provided. Similarly, the gravity drain port 156 and / or proximal end of the bladder catheter 116 is not one of the ureteral catheters 112, 114, but the bladder catheter 116 is allowed to drain by gravity drain. A different connector configuration can be provided to ensure that. In other embodiments, ports 154, 155, 156 and / or proximal ends of catheters 112, 114, 116 can include visual markings to aid in the correct configuration of the fluid collection system.

In some embodiments, urine received within vacuum ports 154 and 155 may be directed through a Y-shaped conduit to a single vacuum outflow port 158 located on the proximal side 160 of the connector 150. it can. As in the previous embodiment, the vacuum outflow port 158 is provided by a suitable flexible tube or other conduit for drawing urine from the body and / or inducing negative pressure in the ureter and / or kidney. It can be connected to a fluid collection vessel 712 and / or pump 710. In some embodiments, the outflow port 156 and / or the connector 150 is attached only to a vacuum source or pump that operates within a predetermined pressure range or power level and provides ureteral catheters 112, 114 to a high level or intensity. It can be configured to prevent exposure to negative pressure. The proximal side 160 of the connector 150 can also be provided with a gravity outflow port 162 for fluid communication with the inflow port 156. The gravity outflow port 162 can be configured to be directly connected to the urine collection container 712 for urine collection by gravity drainage.

Continuing with reference to FIG. 17C, in some embodiments, the vacuum outflow port 158 and the gravity outflow port 162 are single sockets 164, brackets, or connectors to facilitate system configuration and implementation. It is coupled to and placed in close proximity so that fluid communication with each port 158, 162 can be established. A single socket or connector has a multi-conduit hose or tube (eg, flexible tubing 166) having a first conduit for fluid communication with the pump 710 and a second conduit for fluid communication with the collection vessel 712. ) Can be combined. Therefore, the user inserts a single socket 164 into the connector 150 and connects an individual conduit to one of the fluid collection vessel 712 and the pump 710 (shown in FIG. 19) to provide an external fluid collection system. Can be easily set. In another embodiment, a length of flexible tubing 166 is connected between the urine collection vessel 712 and the gravity outflow port 162, and a separate length of flexible tubing is vacuumed with the pump 710. It is connected to the outflow port 158.

Illustrative fluid sensor:
With reference to FIG. 1 again, in some embodiments, assembly 100 further comprises a sensor 174 for monitoring fluid properties of urine collected from ureters 6, 8 and / or bladder 10. As discussed herein in connection with FIG. 19, the information obtained from the sensor 174 is transmitted to a central data collection module or processor of an external device such as a pump 710 (shown in FIG. 19). It can be used to control behavior. The sensor 174 is integrally formed with one or more of the catheters 112, 114, 116, for example, embedded in the catheter body or the wall of the tube and fluid communicating with the discharge lumens 124, 140. be able to. In another embodiment, one or more of the sensors 174 can be positioned within the internal circuitry of an external device such as a fluid collection vessel 712 (shown in FIG. 19) or a pump 710.

An exemplary sensor 174 that can be used with the urine collection assembly 100 can include one or more of the following sensor types: For example, catheter assembly 100 can include a conductivity sensor or electrode that samples the conductivity of urine. The normal conductivity of human urine is about 5-10 mS / m. Urine with conductivity outside the expected range may indicate that the patient is suffering from physiological problems and requires further treatment or analysis. The catheter assembly 100 can also include a flow meter for measuring the flow rate of urine through the catheters 112, 114, 116. The flow rate can be used to determine the total volume of fluid excreted from the body. Catheter 112, 114, 116 can also be equipped with a thermometer for measuring urine temperature. Urine temperature can be used to work with the conductivity sensor. Urine temperature can also be used for monitoring purposes as it can indicate a physiological condition in which the urine temperature is outside the normal physiological range. In some embodiments, the sensor 174 can be a urine sample sensor configured to measure the concentration of creatinine and / or protein in the urine. For example, various conductivity sensors and optical spectroscopy sensors may be used to determine sample concentration in urine. Sensors based on color change reagent test strips may also be used for this purpose.

How to insert the urine collection assembly:
A urine collection assembly 100 has been described that includes a ureteral catheter retention portion and a bladder anchor device (eg, a standard or modified Foley type catheter), but methods for inserting and deploying the assembly are here. Will be discussed in detail.

With reference to FIG. 18A, steps for positioning the fluid collection assembly within the patient's body and optionally inducing negative pressure into the patient's ureter and / or kidney are illustrated. As shown in Box 610, a healthcare professional or caregiver inserts a flexible or rigid cystoscope into the bladder through the patient's urethra to obtain visibility of the ureter or opening. Once suitable visualization is obtained, the guidewire is advanced through the urethra, bladder, ureteral opening, ureter to the desired fluid collection position, such as the renal pelvis of the kidney, as shown in Box 612. Once the guidewire is advanced to the desired fluid collection position, the ureteral catheters of the invention (the embodiments thereof are discussed in detail above) are fluid across the guidewire as shown in box 614. Inserted at the collection position. In some examples, the location of the ureteral catheter can be confirmed by fluorescence fluoroscopy, as shown in Box 616. Once the position of the distal end of the catheter is confirmed, the retention portion of the ureteral catheter can be deployed, as shown in box 618. For example, the guide wire can be removed from the catheter, thereby allowing the distal end and / or retention portion to transition to the deployed position. In some embodiments, the deployed distal end of the catheter completes the ureter and / or renal pelvis so that urine can pass from outside the catheter through the ureter into the bladder. Does not block. Moving the catheter can exert force on the ureteral tissue, thus avoiding complete obstruction of the ureter and avoiding the application of force to the side wall of the ureter, which can cause injury.

After the ureteral catheter comes in place and is deployed, the same guidewire can be used with the other ureteral catheter and / or the second ureteral catheter using the same insertion and positioning method described herein. Or it can be used to position in the kidney. For example, a cystoscope can be used to obtain visualization of other ureteral openings in the bladder, and guide wires advance through the visualized ureteral openings to fluid collection positions in other ureters. Can be done. The catheter can be towed with a guide wire and deployed in the manner described herein. Alternatively, the cystoscope and guidewire can be removed from the body. The cystoscope can be reinserted into the bladder over the first ureteral catheter. The cystoscope provides visibility of the ureteral opening to position the second ureteral catheter and assists in advancing the second guidewire to the second ureter and / or kidney. Used in the style described above. Once the ureteral catheter is in place, in some embodiments the guidewire and cystoscope are removed. In other embodiments, the cystoscope and / or guidewire can remain in the bladder and assist in the placement of the bladder catheter.

Optionally, a bladder catheter can also be used. Once the ureteral catheter is in place, the healthcare professional or caregiver inserts the distal end of the bladder catheter in a crushed or contracted state into the bladder through the patient's urethra, as shown in Box 620. Can be done. The bladder catheter can be a conventional Foley bladder catheter or a bladder catheter of the invention as discussed in detail above. Once inserted into the bladder, the anchor connected to and / or associated with the bladder catheter is extended to the deployment position, as shown in box 622. For example, when an inflatable or inflatable catheter is used, the fluid may be directed through the inflatable lumen of the bladder catheter to dilate the balloon structure located within the patient's bladder. In some embodiments, the bladder catheter is inserted into the bladder through the urethra without the use of guide wires and / or cystoscopes. In another embodiment, the bladder catheter is inserted over the same guide wire used to position the ureteral catheter. Thus, when inserted in this way, the ureteral catheter can be arranged to extend from the distal end of the bladder catheter, and optionally, the proximal end of the ureteral catheter drains the bladder catheter. It can be arranged to terminate within the lumen.

In some embodiments, urine is allowed to drain by gravity from the urethra. In other embodiments, negative pressure is induced within the ureteral and / or bladder catheter to promote urine drainage.

With reference to FIG. 18B, steps for using a urine collection assembly for inducing negative pressure in the ureter and / or kidney are illustrated. As shown in box 624, after the indwelling portion of the bladder and / or ureteral catheter is properly positioned and the mooring / storage structure is deployed, the external proximal end of the catheter connects to the fluid collection or pump assembly Will be done. For example, a ureteral catheter can be connected to a pump to induce negative pressure in the patient's renal pelvis and / or kidney. Similarly, a bladder catheter can be connected directly to a urine collection vessel for gravity drainage of urine from the bladder, or to a pump to induce negative pressure in the bladder. ..

Once the catheter and pump assembly is connected, negative pressure is applied to the renal pelvis and / or kidney and / or bladder through the drainage lumen of the ureteral catheter and / or bladder catheter, as shown in Box 626. .. Negative pressure is intended to counter the stagnation-mediated interstitial hydrostatic pressure resulting from elevated intra-abdominal pressure and consequent or elevated renal venous or lymphatic pressure. The negative pressure applied can therefore increase the flow of filtrate through the medullary tubules and reduce water and sodium reabsorption.

In some embodiments, mechanical stimulation is provided to the ureter and / or part of the renal pelvis to complement or correct the therapeutic effects obtained by applying negative pressure. Mechanical stimulation devices, such as linear actuators and other known devices, that are located within the distal portion of the ureteral catheter, eg, to provide vibrational waves, can be activated. Although not intended to be constrained by theory, such stimulating effects are adjacent, for example, by stimulating nerves and / or activating the peristaltic muscles associated with the ureter and / or renal pelvis. It is thought to affect the organization that does. Nerve stimulation and muscle activation can produce changes in pressure gradients or pressure levels within surrounding tissues and organs, which contribute to, or in some cases, the therapeutic benefits of negative pressure therapy. It can be improved. In some embodiments, the mechanical stimulus can comprise a pulsatile stimulus. In other embodiments, low levels of mechanical stimulation can be sustained as negative pressure is provided through the ureteral catheter. In another embodiment, the inflatable portion of the ureteral catheter expands and contracts in a pulsatile manner in a manner similar to the operation of the mechanical stimulation device described herein, stimulating adjacent nerve and muscle tissue. Can be done.

As a result of the applied negative pressure, as shown in Box 628, urine is placed in the catheter at multiple drain ports at its distal end, from which through the drain lumen of the catheter, a fluid collection vessel for disposal. Pulled out to. As the urine is drawn into the collection vessel, in box 630, sensors placed within the fluid collection system can be used to assess the volume of urine collected, some measurements of urine and the physical patient. It provides information about the condition and the composition of the urine formed. In some embodiments, the information obtained by the sensor is processed by a processor associated with the pump and / or another patient monitoring device, as shown in Box 632, and in Box 634, of the associated feedback device. Shown to the user via a visual display.

Illustrative fluid collection system:
An exemplary urine collection assembly and how to position such an assembly within the patient's body have been described, but with reference to FIG. 19, a system 700 for inducing negative pressure in the patient's ureter and / or kidney. However, it will be explained here. The system 700 can include a ureteral catheter, a bladder catheter, or a urine collection assembly 100 as described above herein. As shown in FIG. 19, the ureteral catheters 112, 114 and / or bladder catheters 116 of assembly 100 are connected to one or more fluid collection vessels 712 to collect urine drawn from the renal pelvis and / or bladder. Will be done. In some embodiments, the bladder catheter 116 and the ureteral catheters 112, 114 are connected to different fluid collection vessels 712. The fluid collection vessel 712 connected to the ureteral catheters 112, 114 can communicate fluidly with the external fluid pump 710 to generate negative pressure through the ureteral catheters 112, 114 into the ureter and kidney. As discussed herein, such negative pressure can be provided to overcome interstitial pressure and form urine within the kidney or renal unit. In some embodiments, the connection between the fluid collection vessel 712 and the pump 710 is provided with a fluid lock or fluid barrier, allowing air to enter the renal pelvis or kidney in the event of accidental therapeutic or non-therapeutic pressure changes. Can be prevented. For example, fluid vessel inflow and outflow ports can be located within the vessel below the fluid level. Therefore, air is prevented from entering the medical tubing or catheter through either the inflow or outflow port of the fluid container 712. As mentioned above, the outer portion of the tubing extending between the fluid collection vessel 712 and the pump 710 includes one or more filters to prevent urine and / or particulate matter from entering the pump 710. can do.

As shown in FIG. 19, the system 700 further comprises a controller 714, such as a microprocessor, that is electronically coupled to the pump 710 and has or is associated with a computer-readable memory 716. In some embodiments, the memory 716, when executed, comprises an instruction to cause the controller 714 to receive information from a sensor 174 located on or associated with a portion of assembly 100. Information about the patient's condition can be determined based on the information from sensor 174. Information from sensor 174 can also be used to determine and implement operating parameters for pump 710.

In some embodiments, the controller 714 is integrated within a separate and remote electronic device that communicates with a dedicated electronic device, computer, tablet PC, or pump 710 such as a smartphone. Alternatively, the controller 714 can be contained within the pump 710, controlling both a user interface for manually operating the pump 710 and system functions such as receiving and processing information from the sensor 174. can do.

The controller 714 is configured to receive information from one or more sensors 174 and store the information in the associated computer-readable memory 716. For example, the controller 714 can be configured to receive information from the sensor 174 at a predetermined rate, such as once per second, and determine the conductivity based on the received information. In some embodiments, the algorithm for calculating conductivity also includes other sensor measurements such as urine temperature, which can provide a more robust determination of conductivity.

Controller 714 can also be configured to calculate patient physical statistics or diagnostic indicators that illustrate changes in patient status over time. For example, the system 700 can be configured to identify the total amount of sodium excreted. The total amount of sodium excreted can be based, for example, on a combination of conductivity and conductivity over a time cycle.

Continuing with reference to FIG. 19, the system 700 may further include a feedback device 720, such as a visual display or audio system, to provide information to the user. In some embodiments, the feedback device 720 can be formed integrally with the pump 710. Alternatively, the feedback device 720 can be a separate dedicated or multipurpose electronic device such as a computer, laptop computer, tablet PC, smartphone, or other handheld electronic device. The feedback device 720 is configured to receive a calculated or determined measurement from the controller 714 and present the received information to the user via the feedback device 720. For example, the feedback device 720 can be configured to display the current negative pressure (in mmHg) applied to the urinary tract. In another embodiment, the feedback device 720 is the current urine flow rate, temperature, current conductivity of urine in mS / m units, total urine volume produced during the session, excreted during the session It can be configured to display total sodium content, other physical parameters, or any combination thereof.

In some embodiments, the feedback device 720 further comprises a user interface module or component that allows the user to control the operation of the pump 710. For example, the user can turn on or off the pump 710 through the user interface. The user can also adjust the pressure applied by the pump 710 to achieve greater magnitude or rate of sodium excretion and fluid removal.

Optionally, the feedback device 720 and / or pump 710 further comprises a data transmitter 722 for transmitting information from the device 720 and / or pump 710 to another electronic device or computer network. The data transmitter 722 can utilize short-range or long-range data communication protocols. An example of a short-range data transmission protocol is Bluetooth®. Long-distance data transmission networks include, for example, Wi-Fi or cellular networks. The data transmitter 722 can transmit information to the patient's doctor or caregiver to inform the doctor or caregiver about the patient's current condition. Alternatively, or in addition, the information can be transmitted from the data transmitter 722 to an existing database or information storage location, eg, including information recorded in the patient's electronic medical record (EHR). ..

Continuing with reference to FIG. 19, in addition to the urine sensor 174, in some embodiments, the system 700 further comprises one or more patient monitoring sensors 724. The patient monitoring sensor 724 is a patient's urine composition, blood composition (eg, hematocrit rate, sample concentration, protein concentration, creatinine concentration), and / or blood flow (eg, blood pressure, blood flow) as discussed in detail above. Invasive and non-invasive sensors can be included to measure information about (speed). Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Normal hematocrit is about 25% -40%, preferably about 35% and 40% (eg, 35% -40% red blood cells and 60% -65% plasma by volume).

The non-invasive patient monitoring sensor 724 can include a pulse oximetry sensor, a blood pressure sensor, a heart rate sensor, and a respiratory sensor (eg, a capnography sensor). The invasive patient monitoring sensor 724 can include an invasive blood pressure sensor, a glucose sensor, a blood velocity sensor, a hemoglobin sensor, a hematocrit sensor, a protein sensor, a creatinine sensor, and the like. In yet another embodiment, the sensor may be associated with an extracorporeal blood system or circuit and configured to measure the parameters of blood passing through the tubules of the extracorporeal system. For example, a specimen sensor such as a capacitance sensor or an optical spectroscopy sensor may be associated with a tube of an extracorporeal blood system and may measure a parameter value of the patient's blood as it passes through the tube. The patient monitoring sensor 724 can communicate wiredly or wirelessly with the pump 710 and / or the controller 714.

In some embodiments, the controller 714 is configured to cause the pump 710 to provide treatment for patient-based information obtained from a urine sample sensor 174 and / or a patient monitoring sensor 724, such as a blood monitoring sensor. To. For example, the pump 710 operating parameters can be adjusted based on changes in the patient's blood hematocrit rate, blood protein concentration, creatinine concentration, micturition volume, urine protein concentration (eg albumin), and other parameters. For example, the controller 714 can be configured to receive information about the patient's blood hematocrit rate or creatinine concentration from the patient monitoring sensor 724 and / or the sample sensor 174. The controller 714 can be configured to adjust the operating parameters of the pump 710 based on blood and / or urine measurements. In other examples, the hematocrit rate may be measured cyclically from blood samples taken from the patient. The results of the test can be provided to controller 714 manually or automatically for processing and analysis.

As discussed herein, the measured hematocrit values for a patient can be compared to a given threshold or clinically acceptable value for the general population. In general, hematocrit levels for women are lower than those for men. In other examples, the measured hematocrit value can be compared to the patient baseline value obtained prior to the surgical procedure. When the measured hematocrit value is increased within an acceptable range, the pump 710 may be turned off and the application of negative pressure to the ureter or kidney may be stopped. Similarly, the intensity of negative pressure can be adjusted based on the measured parameter values. For example, the intensity of negative pressure applied to the ureter and kidney can be reduced as the patient's measured parameters begin to approach an acceptable range. In contrast, when undesired tendencies (eg, decreased hematocrit, micturition, and / or creatinine clearance) are identified, the intensity of negative pressure is increased to produce positive physiological results. Can be done. For example, pump 710 may be configured to start by providing a low level of negative pressure (eg, about 0.1 mmHg-10 mmHg). Negative pressure may be gradually increased until a positive trend in patient creatinine levels is observed. However, in general, the negative pressure provided by pump 710 will not exceed about 50 mmHg.

With reference to FIGS. 20A and 20B, an exemplary pump 710 for use with the system is illustrated. In some embodiments, the pump 710 is a micropump that is configured to draw fluid from catheters 112, 114 (eg, shown in FIG. 1) and has a sensitivity or accuracy of about 10 mmHg or less. Desirably, the pump 710 can provide a urine flow range of 0.05 ml / min to 3 ml / min over a long period of time, eg, about 8 hours to about 24 hours / day, 1 to about 30 days, or longer. Is. At 0.2 ml / min, it is expected that approximately 300 mL of urine / day will be collected by System 700. The pump 710 can be configured to provide negative pressure to the patient's bladder, which ranges from about 0.1 mmHg to about 50 mmHg or about 5 mmHg to 20 mmHg (gauge pressure in pump 710). For example, Language Inc. The micropump manufactured by (Model BT100-2J) can be used in combination with the system 700 of the present disclosure. Diaphragm aspirator pumps and other types of commercially available pumps can also be used for this purpose. The peristaltic pump can also be used in conjunction with the system 700. In other embodiments, a piston pump, vacuum bottle, or manual vacuum source can be used to provide negative pressure. In other embodiments, the system can be connected to a wall suction source, such as that available in hospitals, through a vacuum regulator to reduce negative pressure to therapeutically appropriate levels.

In some embodiments, at least a portion of the pump assembly can be located in the patient's urethra, eg, the bladder. For example, a pump assembly can include a pump module and a control module coupled to the pump module, which is configured to direct the movement of the pump module. At least one (one or more) pump modules, control modules, or power sources may be located within the patient's urinary tract. The pump module may include at least one pump element that is positioned within the fluid flow channel and draws fluid through the channel. Some examples of suitable pump assemblies, systems, and methods of use are entitled "Indwelling Pump for Facilityating Removal of Urine from the Urinary Tract" and are co-filed with US Patent Application No. 62 / 550,259. Disclosed in issue (incorporated herein as a whole by reference).

In some embodiments, the pump 710 can be configured for long-term use, thus providing precise suction over, for example, 8 to 24 hours / day, 1 to about 30 days, or longer cycles. It is possible to maintain. Further, in some embodiments, the pump 710 is configured to include a control panel 718 that is manually operated, in which case the user can set the desired suction value. Pump 710 can also include a controller or processor that can be the same controller that operates the system 700, or can be a separate processor dedicated to the operation of pump 710. In either case, the processor is configured to receive instructions both for manual operation of the pump and for automatically operating the pump 710 according to predetermined operating parameters. Alternatively, or in addition, the operation of the pump 710 can be controlled by the processor based on the feedback received from multiple sensors associated with the catheter.

In some embodiments, the processor is configured to operate the pump 710 intermittently. For example, the pump 710 may be configured to emit a negative pressure pulse and continue a period in which no negative pressure is provided. In another embodiment, the pump 710 can be configured to alternate between providing negative and positive pressures to provide alternating flush and pump effects. For example, a positive pressure of about 0.1 mmHg to 20 mmHg, preferably about 5 mmHg to 20 mmHg, can be followed by a negative pressure ranging from about 0.1 mmHg to 50 mmHg.

Treatment for removing excess fluid from patients suffering from blood dilution According to another aspect of the present disclosure, a method for removing excess fluid from a patient suffering from blood dilution is provided. In some examples, blood dilution increases the volume of plasma compared to red blood cells and / or reduces the concentration of red blood cells in the circulation, such as that can occur when the patient is provided with an excessive amount of fluid. Can point to. The method can involve measuring and / or monitoring patient hematocrit levels and determining when blood dilution is properly addressed. Low hematocrit levels are common post-traumatic or post-traumatic conditions that can lead to undesired therapeutic outcomes. Therefore, control of blood dilution and confirmation that hematocrit levels have returned to the normal range are desirable therapeutic outcomes for surgery and postoperative patient treatment.

The steps for removing excess fluid from a patient using the devices and systems described herein are illustrated in FIG. As shown in FIG. 24, the treatment method is to use a ureteral catheter, such as a ureteral catheter, in the patient's ureter and / or so that urine flows from the ureter and / or kidney, as shown in Box 910. Includes steps to deploy in the kidney. The catheter may be configured to avoid obstruction of the ureter and / or kidney. In some embodiments, the fluid collection portion of the catheter may be located within the renal pelvis of the patient's kidney. In some embodiments, the ureteral catheter may be located within each of the patient's kidneys. In other examples, the urine collection catheter may be deployed in the bladder or urinary tract. In some embodiments, the ureteral catheter comprises one or more of any of the retention portions described herein. For example, a ureteral catheter can include a tube that defines a drainage lumen with a spiral retention portion and multiple drainage ports. In other embodiments, the catheter can include an inflatable retention portion (eg, a balloon catheter), a funnel-shaped fluid collection and retention portion, or a pigtail coil.

As shown in Box 912, the method further comprises applying negative pressure to the ureter and / or kidney through a catheter to induce urine production within the kidney and extract urine from the patient. Desirably, the negative pressure is applied over a period of time sufficient to reduce the patient's blood creatinine levels by a clinically significant amount.

Negative pressure may continue to be applied over a predetermined time cycle. For example, the user may be instructed to operate the pump over a period of time selected based on the duration of the surgical procedure or the physiological characteristics of the patient. In other embodiments, the patient's condition may be monitored to determine when adequate treatment is provided. For example, as shown in Box 914, the method may further include monitoring the patient and determining when to stop applying negative pressure to the patient's ureter and / or kidney. In a preferred and non-limiting example, the hematocrit level of the patient is measured. For example, a patient monitoring device may be used to periodically acquire hematocrit values. In other examples, blood samples may be taken periodically and hematocrit may be measured directly. In some examples, the concentration and / or volume of urine excreted from the body through the catheter may also be monitored to determine the rate at which urine is produced by the kidneys. Similarly, excreted urination may be monitored to determine protein concentration and / or creatinine clearance rate for the patient. Reduced creatinine and protein levels in urine can indicate overdilution and / or impaired renal function. The measured values are compared to a given threshold to assess whether negative pressure therapy improves the patient's condition and whether it should be corrected or discontinued. For example, as discussed herein, the preferred range for patient hematocrit may be 25% -40%. In other preferred and non-limiting examples, patient weight may be measured and compared to dry weight, as described herein. The measured changes in patient weight demonstrate that fluid is being removed from the body. Therefore, a return to dry body weight indicates that the blood dilution is well controlled and the patient is not overdiluted.

As shown in Box 916, the user may stop the pump from providing negative pressure therapy once a positive result is identified. Similarly, patient blood parameters may be monitored to assess the effectiveness of the negative pressure applied to the patient's kidneys. For example, the capacitance or specimen sensor may be installed to communicate fluid with the tubes of the extracorporeal blood management system. Sensors may be used to measure information representing blood protein, oxygen, creatinine, and / or hematocrit levels. The measured blood parameter values may be measured persistently or periodically and compared to various threshold or clinically acceptable values. Negative pressure may continue to be applied to the patient's kidney or ureter until the measured parameter values are within clinically acceptable limits. Once the measured value is within the threshold or clinically acceptable range, the application of negative pressure may be stopped, as shown in Box 916.

Treatment of Patients Undergoing Resuscitation Fluid Procedures According to another aspect of this disclosure, methods for removing excess fluid for patients undergoing resuscitation fluid procedures, such as coronary artery bypass surgery, by removing excess fluid from the patient. Is provided. During the resuscitation infusion, a solution such as saline and / or starch solution is introduced into the patient's bloodstream by a suitable fluid delivery process such as intravenous infusion. For example, in some surgical procedures, the patient may be supplied with a daily intake of normal fluid 5-10 times. Fluid replacement or resuscitation fluids may be provided to replenish fluid lost through sweating, bleeding, dehydration, and similar processes. For surgical procedures such as coronary artery graft bypass, resuscitation fluids are provided to help maintain the patient's fluid balance and blood pressure within appropriate rates. Acute kidney injury (AKI) is a known complication of coronary artery bypass surgery. AKI is associated with long-term hospitalization and increased morbidity and mortality, even in patients who do not progress to renal failure. Kim, et al. , Relationship between a perioperative intravenous fluid administration strategy and acute kidney injury following off-pump coronary artery bypass surgery: an observational study, Critical Care 19: see 350 (1995). Introducing fluid into the blood also reduces hematocrit levels, which have been shown to further increase mortality and morbidity. Studies have also demonstrated that introducing saline solutions into patients can reduce renal function and / or interfere with natural fluid management processes. Therefore, proper monitoring and control of renal function can produce improved outcomes, especially reducing postoperative cases of AKI.

A method of treating a patient receiving a resuscitation fluid is illustrated in FIG. As shown in Box 1010, the method uses a ureteral catheter in the patient's ureter and / or so that the flow of urine from the ureter and / or kidney is not blocked by obstruction of the ureter and / or kidney. Includes steps to deploy in the kidney. For example, the fluid collection portion of the catheter may be located within the renal pelvis. In other examples, the catheter may be deployed in the bladder or urinary tract. The catheter can include one or more of the ureteral catheters described herein. For example, a catheter can include a tube that defines a drainage lumen and has a helical retention section and multiple drainage ports. In other embodiments, the catheter can include an inflatable retaining portion (eg, a balloon catheter) or a pigtail coil.

Optionally, the bladder catheter may also be deployed within the patient's bladder, as shown in box 1012. For example, a bladder catheter may be positioned to seal the urethral opening and prevent the passage of urine from the body through the urethra. The bladder catheter can include an inflatable anchor (eg, a Foley catheter) to maintain the distal end of the catheter within the bladder. Other sequences of coils and helices, as described herein, may also be used to obtain proper positioning of the bladder catheter. A bladder catheter can be configured to collect urine that has entered the patient's bladder prior to placement of the ureteral catheter. The bladder catheter may also collect urine, which flows past the fluid collection portion of the ureteral catheter and enters the bladder. In some embodiments, the proximal portion of the ureteral catheter may be located within the drainage lumen of the bladder catheter. Similarly, the bladder catheter may be advanced into the bladder using the same guide wire used to position the ureteral catheter. In some embodiments, negative pressure may be provided to the bladder through the drainage lumen of the bladder catheter. In other embodiments, the negative pressure may be applied only to the ureteral catheter. In that case, the bladder catheter is ejected by gravity.

As shown in box 1014, following deployment of the ureteral catheter, negative pressure is applied to the ureter and / or kidney through the ureteral catheter. For example, negative pressure can be applied over a time cycle sufficient to extract urine containing a portion of the fluid provided to the patient during the resuscitation infusion procedure. As described herein, negative pressure can be provided by an external pump connected to the proximal end or port of the catheter. The pump can be operated continuously or periodically, depending on the patient's therapeutic requirements. In some cases, the pump may alternate between the application of negative pressure and the application of positive pressure.

Negative pressure may continue to be applied over a predetermined time cycle. For example, the user may be instructed to operate the pump over a time cycle selected based on the duration of the surgical procedure or the physiological characteristics of the patient. In other embodiments, the patient's condition may be monitored to determine when a sufficient amount of fluid has been withdrawn from the patient. For example, as shown in Box 1016, the fluid expelled from the body may be collected and the total volume of the acquired fluid may be monitored. In that case, the pump can continue to operate until a given fluid volume has been collected from the ureter and / or bladder catheter. The predetermined fluid volume may be based, for example, on the volume of fluid provided to the patient prior to and during the surgical procedure. As shown in Box 1018, the application of negative pressure to the ureter and / or kidney is stopped when the total volume of collected fluid exceeds a predetermined fluid volume.

In other embodiments, pump operation can be determined based on the patient's measured physiological parameters such as measured creatinine clearance, blood creatinine levels, or hematocrit rate. For example, as shown in Box 1020, urine collected from a patient may be analyzed by one or more sensors associated with a catheter and / or pump. The sensor can be a capacitance sensor, a sample sensor, an optical sensor, or a similar device configured to measure urine sample concentration. Similarly, as shown in Box 1022, the patient's blood creatinine or hematocrit levels can be analyzed based on the information obtained from the patient monitoring sensors described above. For example, the capacitance sensor may be installed within an existing extracorporeal blood system. The information acquired by the capacitance sensor may be analyzed to determine the patient's hematocrit rate. The measured hematocrit rate may be compared to some expected or therapeutically acceptable value. The pump may continue to apply negative pressure to the patient's ureter and / or kidney until a measured value within the therapeutically acceptable range is obtained. Once a therapeutically acceptable value is obtained, the application of negative pressure may be stopped, as shown in box 1018.

In other examples, as shown in Box 2024, it may be assessed whether the patient's weight has been measured and removed from the patient by fluid-applied negative pressure therapy. For example, a patient's measured body weight (including fluid introduced during a resuscitation infusion procedure) can be compared to the patient's dry weight. As used herein, dry body weight is defined as normal body weight as measured when the patient is not overdiluted. For example, a patient who is breathing comfortably without suffering from elevated blood pressure, stunned or muscle cramps, swelling of the legs, feet, arms, hands, or around the eyes. It is likely that it does not have excess fluid. The body weight measured when the patient does not suffer from such symptoms can be dry body weight. The patient's body weight can be measured cyclically until the measured body weight is close to the dry body weight. As shown in box 1018, the application of negative pressure can be stopped when the measured body weight is close (eg, within 5% -10% of dry body weight).

Experimental Example:
Induction of negative pressure in the renal pelvis of domestic pigs was performed for the purpose of evaluating the effect of negative pressure therapy on renal depression in the kidney. The purpose of these studies was to demonstrate whether the negative pressure delivered into the renal pelvis significantly increased micturition in a porcine model of renal stagnation. In Example 1, a pediatric Fogarty catheter, commonly used in embolectomy or bronchoscopy applications, was used in the porcine model solely for evidence of the principle of inducing negative pressure in the renal pelvis. It is not suggested that Fogarty catheters are used in humans in clinical settings to avoid injury to urinary tract tissue. In Example 2, a ureteral catheter 112, shown in FIGS. 2A and 2B, was used, which included a spiral retention portion for mounting or maintaining the distal portion of the catheter in the renal pelvis or kidney.

(Example 1)
METHODS: Four domestic pigs 800 were used for the purpose of assessing the effect of negative pressure therapy on renal depression in the kidney. As shown in FIG. 21, pediatric Fogarty catheters 812, 814 were inserted into the renal pelvis regions 820, 821 of the kidneys 802, 804 of the four pigs 800, respectively. Catheter 812, 814 were deployed within the renal pelvis region by inflating the expandable balloon to a size sufficient to seal the renal pelvis and maintain the position of the balloon within the renal pelvis. Catheter 812, 814 extend from the renal pelvis 802, 804 through the bladder 810 and the urethra 816 to the fluid collection vessel outside the pig.

Urination of two animals was collected over a 15 minute cycle to establish a baseline for micturition volume and rate. Urination of the right kidney 802 and the left kidney 804 was measured individually and found to be significantly variable. Creatinine clearance values were also determined.

Renal stagnation (eg, venous stagnation or reduced blood flow in the kidney) partially occludes the inferior vena cava (IVC) with an inflatable balloon catheter 850 just above the renal venous outlet, to the right of animal 800. It was induced in kidney 802 and left kidney 804. A pressure sensor was used to measure the IVC pressure. The normal IVC pressure was 1-4 mmHg. By inflating the balloon of catheter 850 to about 3/4 of the IVC diameter, the IVC pressure was increased to 15-25 mmHg. Inflatation of the balloon up to about 3/4 of the IVC diameter resulted in a 50-85% reduction in urination. Complete occlusion generated IVC pressure greater than 28 mmHg and was associated with a reduction of at least 95% in micturition.

One kidney of each animal 800 was untreated and donated as a control (“control kidney 802”). A ureteral catheter 812 extending from the control kidney was connected to a fluid collection vessel 819 to determine fluid levels. One kidney of each animal (“therapeutic kidney 804”) is combined with a negative pressure source connected to the ureteral catheter 814 (eg, a regulator designed to more accurately control small magnitude negative pressure). He was treated with negative pressure from a catheter pump 818). The pump 818 was an Air Cadet Vacuum Pump manufactured by Core-Parmer Instrument Company (model number EW-07530-85). Pump 818 was connected in series with the regulator. The regulator is available from Airtrol Components Inc. It was V-800 Series Precision Vacuum Cleaner-1 / 8 NPT Ports (model number V-800-10-W / K).

Pump 818 was operated to induce negative pressure within the renal pelvis 820, 821 of the treated kidney according to the following protocol. First, the effect of negative pressure was investigated under normal conditions (eg, without inflating the IVC balloon). Four different pressure levels (-2, -10, -15, and -20 mmHg) were applied 15 minutes each to determine the rate of urine and creatinine clearance produced. The pressure level was controlled and determined in the regulator. Following -20 mmHg therapy, the IVC balloon was inflated, increasing the pressure by 15-20 mmHg. The same four negative pressure levels were applied. Urination volume and creatinine clearance rates for stagnation control kidney 802 and treatment kidney 804 were obtained. Animal 800 was stagnant by a 90 minute partial occlusion of IVC. Treatment was provided over 60 minutes of the 90-minute stagnation cycle.

Following collection of micturition and creatinine clearance data, kidneys from one animal underwent macroscopic examination and were then immobilized in 10% neutral buffered formalin. Following macroscopic examination, tissue sections were obtained and examined, and enlarged images of the sections were captured. Sections were inspected using an upright Olympus BX41 light microscope and images were captured using an Olympus DP25 digital camera. Specifically, photomicrograph images of the sampled tissue were obtained at a low magnification (20x original magnification) and a high magnification (100x original magnification). The images obtained underwent histological evaluation. The purpose of the evaluation was to histologically examine the tissue and qualitatively characterize the stagnation and tubular degeneration of the resulting sample.

Surface mapping analysis was also performed on both sides of the resulting kidney tissue. Specifically, samples were stained and analyzed to assess differences in tubular size for treated and untreated kidneys. Image processing techniques were used to calculate the number and / or relative percentage of pixels with different tints in the stained image. The calculated measurement data were used to determine the volume of different anatomical structures.

result
Urination and creatinine clearance Urination volume varied significantly. Three causes of variability in micturition volume were observed during the study. Inter-individual and hemodynamic variations have been a promising cause of variations known in the art. A third cause of variability in micturition has been identified in the experiments discussed herein, i.e., contralateral intra-individual variability in micturition, based on information and ideas previously unknown. ..

Baseline micturition was 0.79 ml / min for one kidney and 1.07 ml / min for the other kidney (eg, 26% difference). The amount of urination is an equal temperament calculated from the amount of urination for each animal.

Treated renal micturition dropped from 0.79 ml / min to 0.12 ml / min (15.2% baseline) when the stagnation was provided by inflating the IVC balloon. By comparison, control renal micturition during stagnation dropped from 1.07 ml / min to 0.09 ml / min (8.4% of baseline). Based on micturition volume, the relative increase in treated renal micturition compared to control renal micturition was calculated according to the following equation.
(Therapeutic treatment / baseline treatment) / (Therapeutic control / baseline control) = Relative increase (0.12 ml / min / 0.79 ml / min) / (0.09 ml / min / 1.07 ml / min)
= 180.6%

Therefore, the relative increase in treated renal micturition was 180.6% compared to controls. The results show a greater reduction in urine production caused by stagnation on the control side compared to the treatment side. Presenting the results as a relative percentage difference in micturition regulates the difference in micturition between the kidneys.

Creatinine clearance measurements for baseline, stagnation, and treatment areas for one of the animals are shown in FIG.

Gross Examination and Histological Evaluation Based on macroscopic examination of the control kidney (right kidney) and the treatment kidney (left kidney), it was determined that the control kidney had a uniform dark brown color, which was compared to the treatment kidney. Corresponds to more stagnation in the control kidney. The qualitative evaluation of enlarged section images also focused on increased depression in the control kidney compared to the treated kidney. Specifically, as shown in Table 1, the treated kidney exhibited lower levels of depression and tubular degeneration compared to the control kidney. The following qualitative scales were used to evaluate the resulting slides.

As shown in Table 1, the treated kidney (left kidney) exhibited only mild depression and tubular degeneration. In contrast, the control kidney (right kidney) presented with moderate stagnation and tubular degeneration. These results were obtained by analysis of the slides discussed below.

23A and 23B are low and high magnification photomicrographs of the animal's left kidney (treated with negative pressure). Based on histological examination, low intravascular stagnation at the epithelial border was identified as indicated by the arrows. As shown in FIG. 23B, a single tubule with a glassy column (as identified by an asterisk) was identified.

23C and 23D are low and high resolution light micrographs of the control kidney (right kidney). Based on histological examination, moderate intravascular stagnation at the epithelial border was identified as indicated by the arrow in FIG. 23C. As shown in FIG. 23D, several tubules with a vitreous column were present in the tissue sample (as identified by the asterisk in the image). The presence of a substantial number of vitreous cylinders is evidence of hypoxia.

The surface mapping analysis provided the following results. It was determined that the treated kidney had a fluid volume 1.5 times larger in the Bowman's space and a fluid volume 2 times larger in the tubular lumen. The increased fluid volume in the Bowman's space and tubular lumen corresponds to increased urination. In addition, the treated kidney was determined to have 5 times less blood volume in the capillaries than the control kidney. The increased volume in the treated kidney is (1) a decrease in individual capillary size compared to the control kidney and (2) an increase in the number of capillaries in the treated kidney without visible red blood cells compared to the control kidney, ie. Appears as a result of less stagnation indicators in the therapeutic organs.

Summary These results showed that the control kidney had more tubules with more stagnation and intraluminal vitreous casts, representing protein-rich intraluminal material compared to the treated kidney. Show that. Therefore, the treated kidney exhibits a lower degree of loss of renal function. Although not intended to be constrained by theory, it is believed that organ hypoxemia continues as severe depression develops in the kidneys. Hypoxemia interferes with oxidative phosphorylation in organs (eg, ATP production). Loss of ATP and / or reduction of ATP production blocks active transport of protein and increases intraluminal protein content, which manifests as a vitreous column. The number of renal tubules with intraluminal vitreous columns correlates with the degree of loss of renal function. Therefore, the reduced number of renal tubules in the treated left kidney is considered to be physiologically significant. Although not intended to be constrained by theory, these results prevent or prevent damage to the kidney by applying negative pressure to a catheter inserted into the renal pelvis to promote urination. It is thought to indicate that it will be obtained.

(Example 2)
Methods Four domestic pigs (A, B, C, D) were sedated and anesthetized. Pig-specific vitals were monitored throughout the experiment and cardiac output was measured at the end of each 30-minute phase of the study. A ureteral catheter, such as the ureteral catheter 112 shown in FIGS. 2A and 2B, was deployed within the renal pelvis region of each porcine kidney. The catheter deployed was a 6 French catheter with an outer diameter of 2.0 ± 0.1 mm. The catheter is 54 ± 2 cm long and does not include the distal retention section. The retention portion had a length of 16 ± 2 mm. As shown in catheter 112 in FIGS. 2A and 2B, the retention portion included two complete coils and one proximal half coil. The outer diameter of the complete coil shown by line D1 in FIGS. 2A and 2B was 18 ± 2 mm. The half coil diameter D2 was about 14 mm. The retaining portion of the deployed ureteral catheter included six drainage openings, as well as an additional opening at the distal end of the catheter tube. The diameter of each of the discharge openings was 0.83 ± 0.01 mm. The distance between the adjacent discharge openings 132, specifically, the linear distance between the discharge openings when the coil was straightened, was 22.5 ± 2.5 mm.

The ureteral catheter was positioned to extend from the renal pelvis of the pig, through the bladder, and the urethra, to the fluid collection vessel outside each pig. Following the placement of the ureteral catheter, a pressure sensor for measuring IVC pressure was placed within the IVC at a location distal to the renal vein. Inflatable balloon catheters, specifically NuMED Inc. A PTS (R) percutaneous balloon catheter (30 mm diameter x 5 cm length) from (Hopkinton, NY) was dilated within the IVC at a location proximal to the renal vein. Thermodilution catheters, specifically Edwards Lifescients Corp. A Swan-Ganza heat-diluted pulmonary artery catheter manufactured by (Irvine, CA) was then placed in the pulmonary artery for the purpose of measuring cardiac output.

First, baseline micturition was measured over 30 minutes and blood and urine samples were collected for biochemical analysis. Following a 30 minute baseline cycle, the balloon catheter was inflated to increase the IVC pressure from a baseline pressure of 1-4 mmHg to an ascending stagnation pressure of approximately 20 mmHg (+/- 5 mmHg). A stagnation baseline was then collected with a corresponding blood and urine analysis over 30 minutes.

At the end of the stagnation cycle, elevated stagnation IVC pressure was maintained and negative pressure diuretic therapy was provided to pigs A and C. Specifically, pigs (A, C) were treated by applying a negative pressure of -25 mmHg through a ureteral catheter using a pump. As in the above embodiment, the pump was an Air Cadet Vacuum Pump manufactured by Core-Parmer Instrument Company (model number EW-07530-85). The pump was connected in series with the regulator. The regulator is available from Airtrol Components Inc. It was V-800 Series Precision Vacuum Cleaner-1 / 8 NPT Ports (model number V-800-10-W / K). Pigs were observed over 120 minutes as treatment was provided. Blood and urine collections were performed every 30 minutes during the treatment cycle. Two of the pigs (B, D) were treated as a stagnation control (eg, no negative pressure was applied to the renal pelvis through the ureteral catheter) and two pigs (B, D) had negative pressure diuresis. It means that he did not receive therapy.

Following collection of urination and creatinine clearance data over a 120-minute treatment cycle, animals were sacrificed and kidneys from each animal underwent macroscopic examination. Following macroscopic examination, tissue sections were obtained and examined, and enlarged images of the sections were captured.

Results Measurements collected during baseline, stagnation, and treatment cycle are provided in Table 2. Specifically, micturition, serum creatinine, and urinary creatinine measurements were obtained for each time cycle. These values allow the calculation of measured creatinine clearance as follows.
In addition, neutrophil zeratinase-binding lipocalin (NGAL) levels were measured from serum samples obtained at each time cycle, and kidney injury molecule 1 (KIM-1) levels were obtained at each time cycle urine sample. Measured from. Qualitative histological views determined from scrutiny of the resulting tissue sections are also included in Table 2.

Animal A: Animal weighed 50.6 kg, had a baseline micturition volume of 3.01 ml / min, a baseline serum creatinine of 0.8 mg / dl, and CrCl of 261 ml / min was measured. .. It should be noted that these measurements were non-characteristically higher compared to the other animals studied, in addition to serum creatinine. Congestion was associated with a 98% reduction in micturition volume (0.06 ml / min) and a> 99% reduction in CrCl (1.0 ml / min). Treatment with negative pressure applied through a ureteral catheter was associated with urination and CrCl of 17% and 12% of baseline values, respectively, and 9 and> 10 times the stagnation value, respectively. Levels of NGAL varied throughout the experiment, ranging from 68% of baseline during depression to 258% of baseline after 90 minutes of therapy. The final value was 130% of the baseline. KIM-1 levels were 6x and 4x baseline over the first two 30-minute time frames after baseline assessment, respectively, of baseline values over the last three collection cycles. It increased up to 68 times, 52 times, and 63 times. The serum creatinine for 2 hours was 1.3 mg / dl. Histological examination revealed an overall level of depression of 2.4% as measured by blood volume in the capillary space. Histological examination also focused on intraluminal vitreous cylinders and several tubules with some degree of tubular epithelial degeneration and found to be consistent with cell damage.

Animal B: The animal weighed 50.2 kg, had a baseline micturition volume of 2.62 ml / min, and CrCl of 172 ml / min (which was also higher than expected) was measured. Congestion was associated with an 80% reduction in micturition volume (0.5 ml / min) and an 83% reduction in CrCl (30 ml / min). At 50 minutes after becoming congested (20 minutes after the stagnation baseline cycle), the animals suffered a plunge in mean arterial pressure and respiratory rate, followed by tachycardia. An anesthesiologist administered a dose of phenylephrine (75 mg) to prevent cardiogenic shock. Phenylephrine is indicated for intravenous administration when blood pressure drops below safe levels during anesthesia. However, because the experiment was testing the effect of stagnation on renal physiology, administration of phenylephrine made the rest of the experiment indistinguishable.

Animal C: Animal weighs 39.8 kg, has a baseline micturition volume of 0.47 ml / min, has a baseline serum creatinine of 3.2 mg / dl, and measures CrCl of 5.4 ml / min. Was done. Congestion was associated with a 75% reduction in urination (0.12 ml / min) and a 79% reduction in CrCl (1.6 ml / min). It was determined that the baseline NGAL level was> 5 times the upper limit of normal (ULN). Treatment with negative pressure applied to the renal pelvis through a ureteral catheter was associated with normalization of urination (101% baseline) and 341% improvement in CrCl (18.2 ml / min). Levels of NGAL varied throughout the experiment, ranging from 84% of baseline in stagnation to 47% to 84% of baseline between 30 and 90 minutes. The final value was 115% of baseline. KIM-1 levels decreased by 40% from baseline within the first 30 minutes of stagnation, 8.7-fold, 6.7-fold, and 6.6-fold, respectively, over the remaining 30-minute time frame. It increased up to 2 times and 8 times. Serum creatinine levels at 2 hours were 3.1 mg / dl. Histological examination revealed an overall stagnation level of 0.9% as measured by blood volume in the capillary space. It was noted that the renal tubules were histologically normal.

Animal D: Animal weighs 38.2 kg, has baseline urination of 0.98 ml / min, baseline serum creatinine of 1.0 mg / dl, and CrCl of 46.8 ml / min is measured. It was. Congestion was associated with a 75% reduction in micturition volume (0.24 ml / min) and a 65% reduction in CrCl (16.2 ml / min). Persistent stagnation was associated with a 66% -91% reduction in urination and an 89% -71% reduction in CrCl. Levels of NGAL varied throughout the experiment, ranging from 127% of baseline in stagnation to a final value of 209% of baseline. KIM-1 levels remain 1 to 2 times baseline over the first 2 30-minute time frames after baseline assessment and of baseline values over the last 3 30-minute cycles. It increased up to 190 times, 219 times, and 201 times. The 2-hour serum creatinine level was 1.7 mg / dl. Histological examination was observed in any of the treated animals with an average capillary size 2.44 times greater than that observed in the tissue sample for the treated animals (A, C). It was revealed that it was 2.33 times larger than the one that was made. Histological assessment also focused on several tubules with intraluminal vitreous casts and tubular epithelial degeneration, showing substantial cell damage.

Summary Although not intended to be constrained by theory, the data collected may support the hypothesis that venous congestion has a physiologically significant effect on renal function. In particular, an increase in renal vein pressure was observed to reduce urination by 75% to 98% within seconds. The association between elevated tubular injury and histological injury within the biomarker is consistent with the extent to which venous congestion occurs, both in terms of injury size and duration.

The data also show that by modifying the interstitial pressure, venous stasis supports the hypothesis that the filtration gradient within the medullary renal unit is reduced. It can be seen that the changes directly contribute to hypoxia and cytotoxicity within the medullary kidney unit. This model does not mimic the clinical status of AKI, but does provide insight into sustained mechanical injury.

The data also show that applying negative pressure to the renal pelvis through a ureteral catheter supports the hypothesis that urination in a venous congestion model can be increased. In particular, negative pressure treatment has been associated with increased micturition and creatinine clearance, which may be clinically significant. A physiologically significant decrease in medulla capillary volume and a slight increase in the biomarkers of tubular injury were also observed. Therefore, it can be seen that negative pressure therapy can directly reduce stagnation by increasing micturition volume and reducing interstitial pressure within the medulla renal unit. Although not intended to be constrained by theory, it can be concluded that negative pressure therapy reduces renal hypoxia and its downstream effects in venous congestion-mediated AKI by reducing stagnation.

Experimental results are found to support the hypothesis that the degree of stagnation is associated with the degree of cytotoxicity observed, both in terms of pressure magnitude and duration. Specifically, an association between reduced micturition and the degree of histological damage was observed. For example, treated pig A with a 98% reduction in micturition suffered more damage than treated pig C with a 75% reduction in micturition. As would be expected, Control Pig D, which suffered a 75% reduction in micturition without the benefits of therapy over two and a half hours, exhibited the most histological damage. These views are broadly consistent with human data demonstrating an increased risk of developing AKI with more venous congestion. For example, Legrand, M. et al. et al. , Observation between systemic hemodynamics and septic act kidney injury in clinically ill patients: a retrospective ovational system. See Critical Care 17: R278-86, 2013.

(Example 3)
METHODS: Induction of negative pressure in the renal pelvis of domestic pigs was performed for the purpose of assessing the effect of negative pressure therapy on blood dilution of blood. The purpose of these studies was to demonstrate whether the negative pressure delivered into the renal pelvis significantly increased micturition in a porcine model of resuscitation fluids.

Two pigs were sedated and anesthetized using ketamine, midazolam, isoflurane, and propofol. One animal (# 6543) was treated with a ureteral catheter and negative pressure therapy as described herein. The other received a Foley-type bladder catheter and served as a control (# 6566). Following catheter placement, the animals were transferred to the berth and monitored for 24 hours.

Fluid overload was induced in both animals using a constant infusion of saline (125 mL / hour) during the 24-hour follow-up. Urination volume was measured every 15 minutes for 24 hours. Blood and urine samples were collected every 4 hours. As shown in FIG. 21, the therapy pump 818 uses a pressure of -45 mmHg (+/- 2 mmHg) to induce negative pressure within the renal pelvis 820, 821 (shown in FIG. 21) of both kidneys. Was set to.

Results Both animals received 7 L of saline over a 24-hour cycle. The treated animal produced 4.22 L of urine, while the control produced 2.11 L. At the end of 24 hours, the control stored 4.94 L of the administered 7 L, while the treated animal stored 2.81 L of the administered 7 L. FIG. 26 illustrates changes in serum albumin. The treated animals showed a 6% drop in serum albumin concentration over a 24-hour period, while the control animals showed a 29% drop.

Summary Although not intended to be constrained by theory, the data collected support the hypothesis that fluid overload induces clinically significant effects on renal function and, as a result, blood dilution. Conceivable. In particular, it has been observed that administration of large amounts of intravenous saline cannot be effectively eliminated, even by healthy kidneys. The resulting fluid accumulation leads to blood dilution. The data also hypothesize that applying negative pressure diuretic therapy to fluid overloaded animals can increase urination, improve net fluid balance, and reduce the effect of resuscitation fluids on the development of blood dilution. I think I support it.

The aforementioned examples and embodiments of the present invention have been described with reference to various examples. Modifications and modifications will be recalled to those skilled in the art upon perusal and understanding of the above-mentioned examples. Therefore, the aforementioned examples should not be construed as limiting this disclosure.

Claims (129)

A method for promoting urination from the kidneys
(A) Inserting a catheter into the patient's kidney, renal pelvis, or at least one of the urinary tracts adjacent to the renal pelvis.
A drainage lumen, the drainage lumen comprising a distal portion and a proximal portion configured to be located within the patient's kidney, renal pelvis, and / or urinary tract adjacent to the renal pelvis. The distal portion comprises a retention portion with a funnel-shaped support having at least one side wall, the funnel-shaped support comprising a first diameter and a second diameter, wherein the first diameter is The second diameter is closer to the end of the distal portion of the drain tube than the first diameter, and the proximal portion of the drain tube has an opening. Essentially absent or absent, with a drainage cavity,
(B) A method comprising applying negative pressure to the proximal portion of the drainage lumen over a time cycle to promote urination from the kidney. The method of claim 1, wherein the flow of urine from the ureter and / or kidney is not impeded by obstruction of the ureter and / or kidney by the catheter. The method of claim 1, wherein the funnel-shaped support has a substantially conical shape. The method of claim 1, wherein the funnel-shaped support has a substantially hemispherical shape. The funnel-shaped support comprises a base portion adjacent to the distal portion of the drain lumen, which allows fluid to flow into the interior of the proximal portion of the drain lumen. The method of claim 1, wherein the method comprises at least one opening that is aligned with the interior of the proximal portion of the discharge lumen. The method of claim 5, wherein at least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm. The method of claim 1, wherein at least one side wall of the funnel-shaped support has a height along the central axis of the funnel-shaped support. The method of claim 7, wherein the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm. The method of claim 7, wherein the ratio of the height of at least one side wall of the funnel-shaped support to the second diameter ranges from about 1:25 to about 5: 1. The at least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm, and the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm. The method of claim 5, wherein the second diameter of the shape support ranges from about 5 mm to about 25 mm. The method of claim 1, wherein at least one side wall of the funnel-shaped support is continuous along the height of the at least one side wall. The method of claim 1, wherein at least one side wall of the funnel-shaped support comprises a solid wall. The method of claim 1, wherein at least one side wall of the funnel-shaped support is formed from a balloon. The method of claim 1, wherein at least one side wall of the funnel-shaped support is discontinuous along the height of the at least one side wall. The method of claim 1, wherein at least one side wall of the funnel-shaped support comprises at least one opening. The method of claim 1, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² . At least one side wall of the funnel-shaped support comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being said to be the second. The maximum distance between a part of the side wall of the first coil and a part of the adjacent side wall of the second coil ranges from about 0 mm to about 10 mm, according to claim 1. the method of. 17. The method of claim 17, wherein the first diameter of the first coil ranges from about 1 mm to about 10 mm, and the second diameter of the second coil ranges from about 5 mm to about 25 mm. 17. The method of claim 17, wherein the diameter of the coil increases towards the distal end of the discharge lumen, resulting in a helical structure having a tapered or partially tapered configuration. At least one side wall of the funnel-shaped support comprises a mesh through which the mesh has a plurality of openings to allow fluid to flow into the discharge lumen. The method according to claim 1, wherein the maximum area of the portion is about 100 mm ² . At least one side wall of the funnel-shaped support comprises an inward facing side and an outward facing side, on which the inward facing side allows fluid to flow into the drain lumen. The method of claim 1, wherein the outward facing side comprises at least one opening to make it possible, with or without an opening essentially. 21. The method of claim 21, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² . The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and a fluid flows inward on the side that faces inward in the radial direction of the first coil. 17. The method of claim 17, comprising at least one opening to allow flow into the drainage lumen. The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and a fluid flows inward on the side that faces inward in the radial direction of the first coil. 17. The method of claim 17, comprising at least two openings to allow flow into the drainage cavity. The first coil includes a side wall including a side that faces inward in the radial direction and a side that faces outward in the radial direction, and one side of the first coil that faces outward in the radial direction. 17. The method of claim 17, wherein the above openings are essentially absent or absent. The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and a fluid flows on the side that faces inward in the radial direction of the first coil. With at least one opening to allow flow into the drainage cavity, the radial outward facing side is essentially free or absent of one or more openings. The method according to claim 17. 15. The method of claim 15, wherein at least one opening on the side wall of the discharge lumen allows fluid flow into the drainage lumen by negative pressure. The method of claim 1, wherein the retaining portion of the drainage lumen further comprises an open distal end to allow fluid to flow into the drainage lumen. The funnel-shaped support has at least a third diameter, the third diameter being less than the second diameter, and the third diameter being farther from the second diameter of the discharge lumen. The method of claim 1, which is close to the end of the position portion. 15. The method of claim 15, wherein the one or more openings are circular. 15. The method of claim 15, wherein the one or more openings are non-circular. The method of claim 1, wherein at least one side wall of the funnel-shaped support is convex. The method of claim 1, wherein at least one side wall of the funnel-shaped support is concave. The method of claim 1, wherein the central axis of the funnel-shaped support is offset with respect to the central axis of the tube of the discharge lumen. The method of claim 1, wherein the distal end of the retaining portion of the funnel-shaped support comprises a plurality of substantially rounded edges. The method of claim 1, wherein at least one side wall of the funnel-shaped support comprises a plurality of leaf-shaped longitudinal folds. 36. The method of claim 36, wherein the at least one leaf-shaped longitudinal fold comprises at least one longitudinal support member. 36. The method of claim 36, wherein the distal end of the at least one phyllodes-shaped longitudinal fold comprises at least one support member. At least one side wall of the funnel-shaped support comprises an inner side wall and an outer side wall, through which the inner side wall allows fluid flow into the interior of a proximal portion of the discharge lumen. The method of claim 1, wherein the method comprises at least one opening. The method of claim 1, wherein the funnel-shaped support comprises a porous material located inside the side wall. The method of claim 1, wherein the funnel-shaped support comprises a porous liner positioned adjacent to the inside of the side wall. The method of claim 1, wherein the catheter is transitionable between a contraction configuration for insertion into the ureter of the patient and a deployment configuration for deployment within the ureter. The discharge cavity is at least one of copper, silver, gold, nickel-titanium alloy, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone. The method according to claim 1, which is formed from the above. A ureteral catheter
A drainage lumen, the drainage lumen comprising a distal portion and a proximal portion configured to be located within the patient's kidney, renal pelvis, and / or ureter adjacent to the renal pelvis. The distal portion comprises a retention portion with a funnel-shaped support having at least one side wall, the funnel-shaped support comprising a first diameter and a second diameter, wherein the first diameter is The second diameter is closer to the end of the distal portion of the ureter than the first diameter, and the proximal portion of the ureter has an opening. A ureteral catheter with a drainage lumen that is essentially absent or absent. The ureteral catheter according to claim 44, wherein the flow of urine from the ureter and / or kidney is not impeded by obstruction of the ureter and / or kidney by the catheter. The ureteral catheter according to claim 44, wherein the funnel-shaped support has a substantially conical shape. The ureteral catheter according to claim 44, wherein the funnel-shaped support has a substantially hemispherical shape. The funnel-shaped support comprises a base portion adjacent to the distal portion of the drain lumen, which allows fluid to flow into the interior of the proximal portion of the drain lumen. 44. The ureteral catheter according to claim 44, comprising at least one opening that is aligned with the interior of the proximal portion of the drain lumen. The ureteral catheter according to claim 48, wherein at least one opening of the base portion has a diameter ranging from about 0.05 mm to about 4 mm. The ureteral catheter according to claim 44, wherein at least one side wall of the funnel-shaped support has a height along the central axis of the funnel-shaped support. The ureteral catheter according to claim 50, wherein the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm. The ureteral catheter according to claim 50, wherein the ratio of the height of at least one side wall of the funnel-shaped support to the second diameter ranges from about 1:25 to about 5: 1. The at least one opening of the base portion has a diameter ranging from about 0.05 mm to about 4 mm, and the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm. The ureteral catheter according to claim 48, wherein the second diameter of the shape support ranges from about 5 mm to about 25 mm. The ureteral catheter according to claim 44, wherein at least one side wall of the funnel-shaped support is continuous along the height of the at least one side wall. The ureteral catheter according to claim 44, wherein at least one side wall of the funnel-shaped support comprises a solid wall. The ureteral catheter according to claim 44, wherein at least one side wall of the funnel-shaped support is formed from a balloon. 44. The ureteral catheter of claim 44, wherein at least one side wall of the funnel-shaped support is discontinuous along the height of the at least one side wall. The ureteral catheter of claim 44, wherein at least one side wall of the funnel-shaped support comprises at least one opening. The ureteral catheter according to claim 44, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² . At least one side wall of the funnel-shaped support comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being said to be the second. 44. The maximum distance between a part of the side wall of the first coil and a part of the adjacent side wall of the second coil ranges from about 0 mm to about 10 mm. Ureter catheter. The ureteral catheter according to claim 60, wherein the first diameter of the first coil ranges from about 1 mm to about 10 mm, and the second diameter of the second coil ranges from about 5 mm to about 25 mm. The ureteral catheter according to claim 60, wherein the diameter of the coil increases toward the distal end of the discharge lumen, resulting in a helical structure having a tapered or partially tapered configuration. At least one side wall of the funnel-shaped support comprises a mesh through which the mesh has a plurality of openings to allow fluid to flow into the drainage lumen. The ureteral catheter according to claim 44, wherein the maximum area of the portion is about 100 mm ² . At least one side wall of the funnel-shaped support comprises an inwardly facing side and an outwardly facing side, on which the inwardly facing side allows fluid to flow into the drainage lumen. 44. The ureteral catheter according to claim 44, comprising at least one opening to make it possible, said outward facing side having essentially no or no opening. The ureteral catheter according to claim 64, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² . The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and the fluid flows inward on the side that faces inward in the radial direction of the first coil. The ureteral catheter according to claim 60, comprising at least one opening to allow fluidization into the drainage lumen. The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and a fluid flows on the side that faces inward in the radial direction of the first coil. The ureteral catheter according to claim 60, comprising at least two openings to allow fluidization into the drainage lumen. The first coil includes a side wall having a side facing inward in the radial direction and a side facing outward in the radial direction, and one side facing outward in the radial direction of the first coil. The ureteral catheter according to claim 60, wherein the above openings are essentially absent or absent. The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and the side that faces inward in the radial direction of the first coil is provided with fluid. With at least one opening to allow flow into the drainage cavity, the radial outward facing side is essentially free or absent of one or more openings. The ureteral catheter according to claim 60. 58. The ureteral catheter of claim 58, wherein at least one opening on the side wall of the drainage lumen allows fluid flow into the drainage lumen by negative pressure. 44. The ureteral catheter of claim 44, wherein the retaining portion of the drainage lumen further comprises an open distal end to allow fluid to flow into the drainage lumen. The funnel-shaped support comprises a third diameter, the third diameter being less than the second diameter, and the third diameter being distal to the drainage lumen from the second diameter. The ureteral catheter according to claim 4, which is close to the end of the portion. The ureteral catheter according to claim 58, wherein the one or more openings are circular. The ureteral catheter according to claim 58, wherein the one or more openings are non-circular. The ureteral catheter according to claim 44, wherein at least one side wall of the funnel-shaped support is convex. The ureteral catheter according to claim 44, wherein at least one side wall of the funnel-shaped support is concave. The ureteral catheter according to claim 44, wherein the central axis of the funnel-shaped support is offset with respect to the central axis of the tube of the discharge lumen. 44. The ureteral catheter of claim 44, wherein the distal end of the retention portion of the funnel-shaped support comprises a plurality of substantially rounded edges. The ureteral catheter according to claim 44, wherein at least one side wall of the funnel-shaped support comprises a plurality of phyllodes-shaped longitudinal folds. The ureteral catheter according to claim 79, wherein the at least one phyllodes-shaped longitudinal fold comprises at least one longitudinal support member. The ureteral catheter according to claim 79, wherein the distal end of the at least one phyllodes-shaped longitudinal fold comprises at least one support member. At least one side wall of the funnel-shaped support comprises an inner side wall and an outer side wall, through which the inner side wall allows fluid flow into the interior of a proximal portion of the drainage lumen. 44. The ureteral catheter according to claim 44, comprising at least one opening of the ureter. 44. The ureteral catheter of claim 44, wherein the funnel-shaped support comprises a porous material located inside the side wall. 44. The ureteral catheter according to claim 44, wherein the funnel-shaped support comprises a porous liner positioned adjacent to the inside of the side wall. 44. The ureteral catheter of claim 44, wherein the catheter is transitionable between a contraction configuration for insertion into the ureter of the patient and a deployment configuration for deployment within the ureter. The discharge cavity is at least partially one of copper, silver, gold, nickel-titanium alloys, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone. The urinary tract catheter according to claim 44, which is formed from the above. A system for inducing negative pressure in a part of a patient's urethra.
At least one ureteral catheter, said at least one ureteral catheter comprising a drainage lumen, which is located in the patient's kidney, in the renal pelvis, and / or in the ureter adjacent to the renal pelvis. The distal portion comprises a distal portion and a proximal portion, the distal portion comprising a retention portion with a funnel-shaped support having at least one side wall, wherein the funnel-shaped support is a first. And a second diameter, the first diameter being less than the second diameter, the second diameter being more distal than the first diameter to the distal portion of the ureter. Close to the end, the proximal portion of the drainage lumen is extended to a deployment position where the diameter of the retention portion is greater than the diameter of the drainage lumen portion, with essentially no or no openings. The funnel-shaped support comprises at least one ureteral catheter comprising at least one drainage opening to allow fluid to flow into the drainage lumen.
A pump that communicates fluid with a proximal portion of the ureteral cavity to induce negative pressure within a portion of the patient's urethra and draw fluid through the ureteral catheter drainage lumen. A system that is configured with a pump. 87. The system of claim 87, wherein the flow of urine from the ureter and / or kidney is not impeded by obstruction of the ureter and / or kidney by the catheter. The system of claim 87, wherein the funnel-shaped support has a substantially conical shape. The system of claim 87, wherein the funnel-shaped support has a substantially hemispherical shape. The funnel-shaped support comprises a base portion adjacent to the distal portion of the drain lumen, which allows fluid to flow into the interior of the proximal portion of the drain lumen. 87. The system of claim 87, comprising at least one opening that is aligned with the interior of the proximal portion of the discharge lumen. The system of claim 91, wherein at least one opening in the base portion has a diameter ranging from about 0.05 mm to about 4 mm. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support has a height along the central axis of the funnel-shaped support. The system of claim 93, wherein the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm. The system of claim 93, wherein the ratio of the height of at least one side wall of the funnel-shaped support to the second diameter ranges from about 1:25 to about 5: 1. The at least one opening of the base portion has a diameter ranging from about 0.05 mm to about 4 mm, and the height of at least one side wall of the funnel-shaped support ranges from about 1 mm to about 25 mm. The system of claim 91, wherein the second diameter of the shape support ranges from about 5 mm to about 25 mm. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support is continuous along the height of the at least one side wall. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support comprises a solid wall. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support is formed from a balloon. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support is discontinuous along the height of the at least one side wall. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support comprises at least one opening. 87. The system of claim 87, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² . At least one side wall of the funnel-shaped support comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being said to be the second. 87. The maximum distance between a part of the side wall of the first coil and a part of the adjacent side wall of the second coil is less than the diameter of about 0 mm to about 10 mm. System. The system of claim 103, wherein the first diameter of the first coil ranges from about 1 mm to about 10 mm, and the second diameter of the second coil ranges from about 5 mm to about 25 mm. 10. The system of claim 103, wherein the diameter of the coil increases towards the distal end of the discharge lumen, resulting in a spiral structure having a tapered or partially tapered configuration. At least one side wall of the funnel-shaped support comprises a mesh through which the mesh has a plurality of openings to allow fluid to flow into the discharge lumen. The system according to claim 87, wherein the maximum area of the portion is about 100 mm ² . At least one side wall of the funnel-shaped support comprises an inward facing side and an outward facing side, on which the inward facing side allows fluid to flow into the drain lumen. 87. The system of claim 87, comprising at least one opening to make it possible, said outward facing side having essentially no or no opening. 10. The system of claim 107, wherein the at least one opening has an area ranging from about 0.002 mm ² to about 100 mm ² . The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and a fluid flows on the side that faces inward in the radial direction of the first coil. 10. The system of claim 103, comprising at least one opening to allow flow into the drainage lumen. The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and a fluid flows on the side that faces inward in the radial direction of the first coil. 10. The system of claim 103, comprising at least two openings to allow flow into the drainage lumen. The first coil includes a side wall including a side that faces inward in the radial direction and a side that faces outward in the radial direction, and one side of the first coil that faces outward in the radial direction. The system of claim 103, wherein the above openings are essentially absent or absent. The first coil includes a side wall having a side that faces inward in the radial direction and a side that faces outward in the radial direction, and a fluid flows on the side that faces inward in the radial direction of the first coil. It comprises at least one opening to allow flow into the drainage lumen, with or without one or more openings on the radial outward facing side. The system according to claim 103. 10. The system of claim 101, wherein at least one opening on the side wall of the discharge lumen allows fluid flow into the drainage lumen by negative pressure. 87. The system of claim 87, wherein the retaining portion of the drainage lumen further comprises an open distal end to allow fluid to flow into the drainage lumen. The funnel-shaped support comprises a third diameter, the third diameter being less than the second diameter, and the third diameter being distal to the drainage lumen from the second diameter. 87. The system of claim 87, which is close to the end of the portion. 10. The system of claim 101, wherein the one or more openings are circular. 10. The system of claim 101, wherein the one or more openings are non-circular. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support is convex. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support is concave. 87. The system of claim 87, wherein the central axis of the funnel-shaped support is offset with respect to the central axis of the tube of the discharge lumen. 87. The system of claim 87, wherein the distal end of the retaining portion of the funnel-shaped support comprises a plurality of substantially rounded edges. 87. The system of claim 87, wherein at least one side wall of the funnel-shaped support comprises a plurality of leaf-shaped longitudinal folds. The system of claim 122, wherein the at least one phyllodes-shaped longitudinal fold comprises at least one longitudinal support member. The system of claim 122, wherein the distal end of the at least one phyllodes-shaped longitudinal fold comprises at least one support member. At least one side wall of the funnel-shaped support comprises an inner side wall and an outer side wall, through which the inner side wall allows fluid flow into the interior of a proximal portion of the discharge lumen. 87. The system of claim 87, comprising at least one opening. 87. The system of claim 87, wherein the funnel-shaped support comprises a porous material located inside the side wall. 87. The system of claim 87, wherein the funnel-shaped support comprises a porous liner located adjacent to the interior of the side wall. 87. The system of claim 87, wherein the catheter is transitionable between a contraction configuration for insertion into the ureter of the patient and a deployment configuration for deployment within the ureter. The discharge cavity is at least partially one of copper, silver, gold, nickel-titanium alloys, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone. The system according to claim 87, which is formed from the above.