pump set, pump set for inducing negative pressure into a patient's bladder, system for providing

专利摘要:
A pump set is available, including a pump module configured to be positioned within an internal portion of a patient's ureter and / or renal pelvis to provide negative pressure to the patient's ureter and / or kidney, the pump including: a housing including a flow channel for carrying fluid, where the housing is configured to be positioned within the inner portion of the ureter and / or the renal pelvis; and a pump element positioned within the channel to extract fluid through the channel; and a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the rate of fluid flow passing through the channel and including a housing configured to be positioned within at least a second internal portion of the patient's ureter, a second portion of the patient's renal pelvis or a second internal portion of the patient's bladder.
公开号:BR112020003830A2
申请号:R112020003830-0
申请日:2018-08-24
公开日:2020-09-08
发明作者:David E. Orr；Jacob L. Upperco；Ii John R. Erbey
申请人:Strataca Systems Limited；
IPC主号:

专利说明:

[0001] [0001] The present disclosure refers to a pump for implantation into a body lumen and, for example, a pump sized for insertion and implantation in a patient's urinary tract to induce negative and / or positive pressure in the bladder, in the ureters and / or in a patient's kidneys. Historic
[0002] [0002] The renal or urinary system includes a pair of kidneys, each kidney being connected by a ureter to the bladder and an urethra to drain the urine produced by the kidneys from the bladder. The kidneys perform several vital functions for the human body, including, for example, filtering the blood to eliminate waste in the form of urine. The kidneys also regulate electrolytes (eg sodium, potassium and calcium) and metabolites, blood volume, blood pressure, blood pH, blood volume, fluid volume, red blood cell production and bone metabolism. A proper understanding of the anatomy and physiology of the kidneys is useful to understand the impact that altered hemodynamics and other fluid overload conditions have on their function.
[0003] [0003] In anatomy normally, both kidneys are located retroperitoneally in the abdominal cavity. The kidneys are encapsulated organs in the form of beans. Urine is formed by nephrons, the functional unit of the kidney, and then flows through a system of converging tubules called collecting ducts. The collecting ducts join to form smaller chalices, then larger chalices, which finally join near the concave portion of the kidney (renal pelvis). A primary function of the renal pelvis is to direct the flow of urine into the ureter. Urine flows from the renal pelvis to the ureter, a tube-like structure that carries urine from the kidneys to the bladder. The outer layer of the kidney is called the cortex and is a rigid fibrous encapsulation. The inside of the kidney is called the marrow. The spinal cord structures are arranged in pyramids.
[0004] [0004] Each kidney consists of approximately one million nephrons. Each nephron includes the glomerulus, Bowman's capsule and tubules. Tubules include the contorted proximal tubule, the loop of Henle, the distal contorted tubule and the collecting duct. The nephrons contained in the cortex layer of the kidney have a different anatomy than those contained in the medulla. The main difference is the length of the Henle handle. Medullary nephrons contain a longer Henle loop, which, under normal circumstances, allows greater regulation of water and sodium reabsorption than in cortex nephrons.
[0005] [0005] The glomerulus is the beginning of the nephron and is responsible for the initial blood filtration. The afferent arterioles pass the blood to the glomerular capillaries, where the hydrostatic pressure pushes water and solutes in the Bowman's capsule. The net filtration pressure is expressed as the hydrostatic pressure in the afferent arteriole minus the hydrostatic pressure in Bowman's space minus the osmotic pressure in the efferent arteriole. Net Filtration Pressure = Hydrostatic Pressure
[0006] [0006] The magnitude of this net filtration pressure defined by Equation 1 determines how much ultrafiltrate is formed in Bowman's space and delivered to the tubules. The remaining blood leaves the glomerulus through the efferent arteriole. Normal glomerular filtration or delivery of ultrafiltrate to the tubules is approximately 90 ml / min / 1.73 m2.
[0007] [0007] The glomerulus has a three-layer filtration structure, which includes the vascular endothelium, a glomerular basement membrane and podocytes. Normally, large proteins, such as albumin and red blood cells, are not filtered in Bowman's space. However, high glomerular pressures and mesangial expansion create changes in the surface area of the basement membrane and greater fenestrations between podocytes, allowing larger proteins to pass into Bowman's space.
[0008] [0008] The ultrafiltrate collected in Bowman's space is delivered first to the proximal contorted tubule. The reabsorption and secretion of water and solutes in the tubules are carried out by a mixture of active transport channels and passive pressure gradients. The proximal contorted tubules normally reabsorb most of the sodium chloride and water and almost all of the glucose and amino acids that have been filtered by the glomerulus. The Henle handle has two components that are designed to concentrate waste in the urine. The descending member is highly permeable to water and reabsorbes most of the remaining water. The rising limb reabsorbs 25% of the remaining sodium chloride, creating a concentrated urine, for example, in terms of urea and creatinine. The distal contorted tubule normally reabsorbs a small proportion of sodium chloride, and the osmotic gradient creates conditions for water to flow.
[0009] [0009] Under normal conditions, there is a liquid filtration of approximately 14 mmHg. The impact of venous congestion can be a significant decrease in liquid filtration, reaching approximately 4 mmHg. See Jessup M., The cardiorenal syndrome: Do we need a change of strategy or a change of tactics , JACC 53 (7): 597-600, 2009 (hereinafter “Jessup”). The second stage of filtration occurs in the proximal tubules. Most of the urine secretion and absorption occurs in tubules in the medullary nephrons. The active transport of sodium from the tubule to the interstitial space initiates this process. However, hydrostatic forces dominate the net exchange of solutes and water. Under normal circumstances, 75% of sodium is believed to be reabsorbed back into the lymphatic or venous circulation. However, as the kidney is encapsulated, it is sensitive to changes in hydrostatic pressures caused by venous and lymphatic congestion. During venous congestion, sodium and water retention can exceed 85%, further perpetuating renal congestion. See Verbrugge et al., The kidney in congestive heart failure: Are natriuresis, sodium, and diuretics really the good, the bad and the ugly European Journal of Heart Failure 2014: 16,133-42 (hereinafter “Verbrugge”). Venous congestion can result, for example, from heart failure, sepsis, burns and other primary morbidities affecting kidney pressure gradients and nephron filtration.
[0010] [0010] Venous congestion can lead to a pre-renal form of acute kidney injury (AKI). Pre-renal AKI is due to a loss of perfusion (or loss of blood flow) through the kidney. Many doctors focus on the lack of flow to the kidney due to shocks. However, there is also evidence that the lack of blood flow out of the organ due to venous congestion can be a prolonged and clinically relevant injury. See Damman K, Importance of venous congestion for worsening renal function in advanced decompensated heart failure, JACC 17: 589-96, 2009 (hereinafter referred to as “Damman”).
[0011] [0011] Prerenal AKI occurs in a wide variety of diagnoses that require hospitalization for intensive treatment. The most prominent hospitalizations are for sepsis and decompensated acute heart failure (ICAD). Other hospitalizations are performed in cases of cardiovascular surgery, general surgery, cirrhosis, trauma, burns and pancreatitis. Although there is great clinical variability in the presentation of these disease states, a common denominator is elevated central venous pressure. In the case of ICAD, high central venous pressure caused by heart failure leads to pulmonary edema and, subsequently, dyspnea, in turn, requiring hospitalization. In the case of sepsis, elevated central venous pressure results largely from aggressive fluid resuscitation. Whether the primary insult was low perfusion due to hypovolemia or sodium and fluid retention, the injury suffered is venous congestion, resulting in inadequate perfusion.
[0012] [0012] Hypertension is another widely recognized condition that creates disorders in the active and passive transport systems of the kidneys. Hypertension directly affects the pressure of the afferent arterioles and results in a proportional increase in the net filtration pressure within the glomerulus. The increase in the filtration fraction also increases the peritubular capillary pressure, which stimulates the reabsorption of sodium and water. See Verbrugge.
[0013] [0013] As the kidney is an encapsulated organ, it is sensitive to pressure changes in the medullary pyramids. High renal venous pressure creates congestion, which leads to increased interstitial pressures. The high interstitial pressures exert forces on the glomerulus and tubules. See Verburgge. In the glomerulus, the high interstitial pressures are directly opposed to filtration. High pressures increase interstitial fluid, thereby increasing hydrostatic pressures in interstitial fluid and peritubular capillaries in the kidney medulla. In both cases, hypoxia can occur, which leads to cell damage and additional loss of perfusion. The net result is an additional exacerbation of the reabsorption of sodium and water, creating negative feedback. See Verbrugge, 133-42. Fluid overload, particularly in the abdominal cavity, is associated with many diseases and health conditions, including high intra-abdominal pressure, abdominal compartment syndrome and acute renal failure. Fluid overload can be treated through renal replacement therapy. See Peters, CD, Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartanon Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIR Study), PLoS ONE (2015) 10 (6) : e0126882. doi: 10.1371 / journal.pone.0126882 (hereinafter referred to as “Peters”). However, such a clinical strategy does not allow any improvement in renal function for patients with cardiorenal syndrome. See Bart B, Ultrafiltration in decompensated heart failure with cardiorenal syndrome, NEJM 2012; 367: 2296-2304 (hereinafter referred to as "Bart").
[0014] [0014] In view of such problematic effects of fluid retention, devices and methods are needed to improve the removal of urine from the urinary tract and, specifically, to increase the quantity and quality of urine output from the kidneys. summary
[0015] [0015] In some examples, there is a pump set comprising: (a) a pump module, in which at least part of the pump module is configured to be positioned within at least part of an internal portion a ureter, an inner portion of a renal pelvis, an inner portion of a bladder or an inner portion of a patient's urethra to supply negative pressure to at least one of the patient's ureters or kidneys, the pump module comprising: a housing comprising an open proximal end, an open distal end, and a side wall that extends there, defining a flow channel for the conduction of fluid through at least one inner part of the patient's ureter, the inner portion of the renal pelvis of the patient, the inner portion of the patient's bladder or the inner portion of the patient's urethra, where at least a portion of the housing is configured to be positioned within at least one inner portion of the ureter, an inner portion that of the renal pelvis, an internal portion of the bladder or an internal portion of the urethra of a patient; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the flow rate of the fluid passing through the channel, the control module comprising a configured housing to be positioned within at least a second inner portion of the patient's ureter, a second inner portion of the patient's renal pelvis, a second inner portion of the patient's bladder or a second inner portion of the patient's urethra.
[0016] [0016] In some examples, a pump set is provided to induce negative pressure in a patient's bladder, the set comprising: a pump module, in which at least a portion of the pump module is configured to be positioned in a portion of a patient's bladder, the pump module comprising a housing comprising an open proximal end, an open distal end and a side wall extending between them, the housing defining a flow channel for conducting fluid through an inner portion the patient's bladder and a pump element at least partially positioned within the channel being configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; a bladder wall support to maintain at least a portion of the bladder wall in an unbroken state, in which the holes in the ureter are not occluded by the bladder wall; and a drainage catheter extending from the proximal end of the pump module through the urethra and the patient's body, the drainage catheter comprising a drainage channel in fluid communication with the pump module channel to direct the fluid expelled from the module body pump.
[0017] [0017] In some examples, there is a pump set comprising: (a) a pump module, in which at least part of the pump module is configured to be positioned within at least part of an internal portion a ureter, an inner portion of a renal pelvis, an inner portion of a bladder or an inner portion of a patient's urethra to supply negative pressure to at least one of the patient's ureters or kidneys, the pump module comprising: a housing comprising an open proximal end, an open distal end and a side wall that extends between the definition of a flow channel for the conduction of fluid through at least an inner part of the patient's ureter, the inner portion of the renal pelvis of the patient or the inner portion of the patient's bladder, wherein at least a portion of the housing comprises a drainage channel comprising a distal portion configured to be positioned within a distal inner portion of the ure having or an internal portion of a patient's renal pelvis; a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the rate of fluid flow passing through the channel, the control module comprising a configured housing to be positioned within a second internal portion of the patient's ureter, a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra, in which the drainage channel is formed integrally with the housing or as a separate tube or conduit in fluid connection with the open distal end of the housing.
[0018] [0018] In some examples, a system is provided to provide negative pressure therapy to a patient's ureter and / or kidney, the system comprising: a pump assembly, comprising: (a) a pump module, at least a part of the pump module is positioned inside at least one inner part of a ureter, inner part of a renal pelvis, inner part of a bladder or inner part of a patient's urethra to supply negative pressure to at least one of the ureters or kidneys of the patient, the pump module comprising: a housing comprising an open proximal end, an open distal end and a side wall extending between the definition of a flow channel for conducting fluid through at least part of the inner portion of the patient's ureter, inner portion of the patient's renal pelvis, inner portion of the patient's bladder or inner portion of the patient's urethra, where at least a portion of the housing is configured for s it is positioned within at least the inner portion of the ureter, the inner portion of the renal pelvis, the inner portion of the bladder or the inner portion of the patient's urethra; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the rate of fluid flow passing through the channel, the control module comprising a configured housing to be positioned in at least one between a second internal portion of the patient's ureter, a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra; a power supply to supply power to the pump set; and a remote control device in wired or wireless communication with the control module, the remote control device being configured to instruct the control module to operate the pump assembly and to receive information from the control module about at least one the pump modules or the patient.
[0019] [0019] In some examples, there is a method for treating a patient, providing negative pressure therapy to a portion of the patient's urinary tract, the method comprising: positioning a pump set comprising: (a) a module pump, where at least a portion of the pump module is configured to be positioned inside at least one inner part of a ureter, inner part of a renal pelvis, inner part of a bladder or inner part of a patient's urethra to provide negative pressure to at least one of the patient's ureters or kidneys, the pump module comprising: a housing comprising an open proximal end, an open distal end and a side wall extending there, defining a flow channel for conduction of fluid through at least an internal portion of the patient's ureter, the internal portion of the patient's renal pelvis or the internal portion of the patient's bladder, where at least part of the housing is located configured to be positioned inside at least an internal portion of the ureter, internal portion of the renal pelvis, internal portion of the bladder or internal portion of the patient's urethra; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the flow rate of the fluid passing through the channel, the control module comprising a configured housing to be positioned within at least one of a second internal portion of the patient's ureter, a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra; and activating the pump module, causing the pump module to draw fluid through the channel to supply negative pressure to a portion of the patient's urinary tract.
[0020] [0020] Some non-limiting embodiments of the present invention will now be described in the following numbered clauses:
[0021] [0021] Clause 1: A pump set comprising: (a) a pump module, in which at least part of the pump module is configured to be positioned within at least an inner portion of a ureter, an inner portion of a renal pelvis, inner portion of a bladder or inner portion of a patient's urethra to supply negative pressure to at least one of the patient's ureters or kidneys, the pump module comprising: a housing comprising an open proximal end, a distal end open, and a side wall that extends between the definition of a flow channel for the conduction of fluid through at least an internal portion of the patient's ureter, the internal portion of the patient's renal pelvis, the internal portion of the patient's bladder or the inner portion of the patient's urethra, where at least a portion of the housing is configured to be positioned within at least one inner part of the ureter, an inner portion of the renal pelvis, an inner portion tender bladder or an internal portion of a patient's urethra; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the flow rate of the fluid passing through the channel, the control module comprising a configured housing to be positioned within at least a second internal portion of the patient's ureter, a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra.
[0022] [0022] Clause 2: Pump set, according to claim 1, characterized by the fact that a maximum outside diameter of the pump module housing is less than a maximum outside diameter of the control module housing.
[0023] [0023] Clause 3: Pump set, according to claim 2, characterized by the fact that the maximum external diameter of the pump module housing is from about 0.5 mm to about 5.0 mm.
[0024] [0024] Clause 4: Pump set, according to any of the preceding claims, characterized by the fact that the maximum outer diameter of the control module housing is greater than the inner diameter of the patient's ureter, so that the module do not pass from the patient's bladder to the ureter.
[0025] [0025] Clause 5: Pump assembly, according to any one of the preceding claims, characterized by the fact that the pump module housing comprises one or more retaining members that extend from the side wall to fix freely a portion of the pump module housing to at least an internal part of the ureter, an internal portion of the renal pelvis or an internal portion of a patient's bladder.
[0026] [0026] Clause 6: Pump set, according to claim 5, characterized by the fact that the retaining members are retractable to allow the removal of the pump module from the ureter, renal pelvis or bladder.
[0027] [0027] Clause 7: Pump assembly, according to claim 5, characterized by the fact that the retaining members have a length when extended by less than about 3 mm.
[0028] [0028] Clause 8: Pump assembly, according to any one of the preceding claims, characterized by the fact that the control module housing comprises one or more retaining members that extend from it to freely secure the housing from the control module to an internal portion of a patient's bladder.
[0029] [0029] Clause 9: Pump assembly according to any one of the preceding claims, characterized by the fact that at least a portion of the housing comprises a drainage channel comprising a distal portion configured to be positioned within at least one between the distal inner portion of the ureter and / or the inner portion of a patient's renal pelvis.
[0030] [0030] Clause 10: Pump assembly, according to claim 9, characterized by the fact that the drainage channel is formed integrally with the housing or as a separate pipe or conduit in fluid connection with the open distal end of the housing.
[0031] [0031] Clause 11: Pump assembly according to claims 9 or 10, characterized by the fact that the distal portion of the drainage channel comprises a coil.
[0032] [0032] Clause 12: Pump assembly according to claims 9, 10 or 11, characterized by the fact that the coil comprises one or more perforations in a side wall of the coil.
[0033] [0033] Clause 13: Pump set according to claims 9, 10, 11 or 12, characterized by the fact that the coil comprises one or more perforations on one side facing into a side wall of the coil.
[0034] [0034] Clause 14: Pump set, according to any one of the preceding claims, characterized by the fact that the pump module housing is integrally formed or connected to the control module housing.
[0035] [0035] Clause 15: Pump assembly according to any one of the preceding claims, characterized by the fact that the control module housing is a generally cylindrical housing comprising an open distal end connected to the open proximal end of the control module housing pump, an open proximal end and a flow channel in fluid communication with the flow channel of the pump module housing and extending between the proximal end and the distal end of the control module housing.
[0036] [0036] Clause 16: Pump assembly, according to any of the preceding claims, characterized by the fact that the control module housing is separate from the pump module housing and in which the electronic circuit of the control module is functionally connected to the pump module via a wired or wireless connection.
[0037] [0037] Clause 17: Pump assembly according to any one of the preceding claims, characterized by the fact that the pump element comprises an impeller positioned within the channel of the pump module compartment that rotates to draw fluid through the channel.
[0038] [0038] Clause 18: Pump assembly according to any one of the preceding claims, characterized by the fact that the pump element comprises a piezoelectric diaphragm positioned within the channel that can be configured to extend and retract alternately to a surface side wall to pull fluid through the channel.
[0039] [0039] Clause 19: Pump assembly, according to claim 18, characterized by the fact that the pump module further comprises a distal valve positioned in a portion of the channel distal to the pump element and a proximal valve positioned in a portion from the channel proximal to the pump element.
[0040] [0040] Clause 20: Pump assembly, according to claim 19, characterized by the fact that the distal valve and the proximal valve comprise a one-way check valve configured to produce a one-way flow of fluid through the channel from the distal end to the proximal end of it.
[0041] [0041] Clause 21: Pump set, according to any of the previous claims, characterized by the fact that the pump module is configured to provide negative pressure between about 0 mmHg and about 150 mmHg.
[0042] [0042] Clause 22: Pump set according to any one of the preceding claims, characterized by the fact that the pump module is configured to produce a negative pressure in the ureter sufficient to establish a pressure gradient through the filtration anatomy of a patient's kidney to facilitate the flow of urine into the ureter.
[0043] [0043] Clause 23: Pump set, according to any one of the preceding claims, characterized by the fact that it also comprises a battery positioned in at least one of the control module compartments or in the pump module compartment to supply power to at least one of the pump modules or elements.
[0044] [0044] Clause 23: Pump set, according to claim 23, characterized by the fact that the battery is rechargeable.
[0045] [0045] Clause 25: Pump set according to any one of the preceding claims, characterized by the fact that the control module comprises a wireless transceiver configured to receive operating instructions from a remote device and provide information on pressure treatment control module to the remote device.
[0046] [0046] Clause 26: Pump set, according to any one of the preceding claims, characterized by the fact that it also comprises an induction coil electronically coupled to at least one pump module or control module to supply energy to it, being the induction coil configured to generate energy when exposed to an electromagnetic field generated by a remote device positioned outside or inside the patient's body.
[0047] [0047] Clause 27: Pump set according to claim 26, characterized by the fact that the induction coil comprises a conductor wire at least partially disposed on a flexible substrate.
[0048] [0048] Clause 28: Pump assembly, according to claim 27, characterized by the fact that the flexible substrate can change from a rolled configuration in which the flexible substrate is rolled around a central axis of the same to a suitable size , for delivery through a catheter, to an implanted configuration in which the flexible substrate is at least partially unwound from the rolled configuration.
[0049] [0049] Clause 29: Pump set, according to claims 26, 27 or 28, characterized by the fact that it also comprises a battery electronically coupled to the induction coil, the battery being configured to be recharged by the energy produced by the coil induction.
[0050] [0050] Clause 30: A pump set for inducing negative pressure in a patient's bladder, the set comprising: a pump module, in which at least a portion of the pump module is configured to be positioned in a portion of a a patient's bladder, the pump module comprising a housing comprising an open proximal end, an open distal end and a side wall extending between them, the housing defining a flow channel for conducting fluid through an inner portion of the patient's bladder patient and a pump element at least partially positioned within the channel that is configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; a bladder wall support to maintain at least a portion of the bladder wall in an unbroken state, in which the holes in the ureter are not occluded by the bladder wall; and a drainage catheter extending from the proximal end of the pump module through the urethra and the patient's body, the drainage catheter comprising a drainage lumen in fluid communication with the pump module channel to direct the expelled fluid body from the pump module.
[0051] [0051] Clause 31: Pump assembly according to claim 30, characterized in that the bladder wall support comprises an inflatable balloon that isolates the trine, comprising an upper surface portion to support an upper bladder wall of the patient and a portion of the lower concave surface.
[0052] [0052] Clause 32: Pump set according to claims 30 or 31, characterized by the fact that the trine isolation balloon has a maximum inflated height of about 5 cm and a maximum inflated width of about 15 cm .
[0053] [0053] Clause 33: Pump set, according to claims 30, 31 or 32, characterized by the fact that the drainage catheter further comprises an inflation lumen in fluid communication with the internal part of the trine isolation balloon for supply fluid to the inside of the trine isolation balloon to inflate the balloon.
[0054] [0054] Clause 34: Pump set, according to claim 33, characterized by the fact that the inflation lumen extends through the drainage channel, so that a central longitudinal axis of the drainage channel is substantially coextensive with a longitudinal central axis of the inflation lumen.
[0055] [0055] Clause 35: Pump assembly according to claims 30, 31, 32, 33 or 34, characterized by the fact that the pump module compartment further comprises a plurality of drainage openings that extend through it to draw fluid from the bladder into the flow channel.
[0056] [0056] Clause 36: Pump set, according to claims 30, 31, 32, 33, 34 or 35, characterized by the fact that the pump module further comprises an annular filter that extends over at least a portion of the side wall of the housing and covers one or more of the plurality of drainage openings to filter the fluid as the fluid is attracted to the flow channel.
[0057] [0057] Clause 37: A pump assembly comprising: (a) a pump module, wherein at least a portion of the pump module is configured to be positioned within at least one of an inner portion of a ureter, a portion inner portion of a renal pelvis, an inner portion of a bladder or an inner portion of a patient's urethra to supply negative pressure to at least one of the patient's ureters or kidneys, the pump module comprising: a housing comprising an open proximal end , an open distal end, and a side wall that extends between the definition of a flow channel for conducting fluid through at least part of the patient's inner ureter, an inner portion of the patient's bladder, a portion of the patient's bladder or an internal portion of the patient's urethra, wherein at least a portion of the housing comprises a drainage channel comprising a distal portion configured to be positioned within the the least a distal inner portion of the ureter or an inner portion of a patient's renal pelvis; a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the rate of fluid flow passing through the channel, the control module comprising a configured housing to be positioned within a second internal portion of the patient's ureter, a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra, in which the drainage channel is formed integrally with the housing or as a separate tube or conduit in fluid connection with the open distal end of the housing.
[0058] [0058] Clause 38: A system for providing negative pressure therapy to a patient's ureter and / or kidney, the system comprising: a pump assembly, comprising: (a) a pump module, in which at least a portion of the pump module is configured to be positioned inside at least one inner part of a ureter, an inner part of a renal pelvis, an inner part of a bladder or an inner part of a patient's urethra to provide negative pressure to at least one of the ureters or kidney, the pump module comprising: a housing comprising an open proximal end, an open distal end and a side wall extending between them defining a flow channel for the conduction of fluid through at least a portion internal portion of the patient's ureter, an internal portion of the patient's renal pelvis, an internal portion of the patient's bladder or an internal portion of the patient's urethra, where at least a portion of the housing is configured to be positioned inside at least an inner part of the ureter, an inner part of the renal pelvis, an inner part of the bladder or an inner part of a patient's urethra; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the rate of fluid flow passing through the channel, the control module comprising a configured housing to be positioned in at least a second internal portion of the patient's ureter, a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra; a power supply to supply power to the pump set; and a remote control device in wired or wireless communication with the control module, the remote control device being configured to instruct the control module to operate the pump assembly and to receive information from the control module about at least one the pump modules or the patient.
[0059] [0059] Clause 39: System, according to claim 38, characterized by the fact that a maximum external diameter of the pump module housing is less than a maximum external diameter of the control module.
[0060] [0060] Clause 40: System, according to claims 38 or 39, characterized by the fact that the control module is sized for insertion into the patient's bladder.
[0061] [0061] Clause 41: System, according to claims 38, 39 or 40, characterized by the fact that the power supply is a battery.
[0062] [0062] Clause 42: System, according to claims 38, 39, 40 or 41, characterized by the fact that the power supply is an induction coil.
[0063] [0063] Clause 43: System, according to claim
[0064] [0064] Clause 44: System, according to claim 38, characterized by the fact that the power supply also comprises a battery electronically coupled to the induction coil, the battery being configured to be recharged by the energy produced by the induction coil.
[0065] [0065] Clause 45: System, according to claim 44, characterized by the fact that the information received from the control device comprises at least indications that the battery is being recharged by the induction coil, an indication that the battery is fully charged or a battery remaining indication.
[0066] [0066] Clause 46: System, according to claims 38, 39, 40, 41, 42, 43, 44 or 45, characterized by the fact that it also comprises a remote database comprising electronic patient health records and in that the remote control device is configured to wirelessly transmit patient information to the remote database.
[0067] [0067] Clause 47: System, according to claims 38, 39, 40, 41, 42, 43, 44, 45 or 46, characterized by the fact that it also comprises sensors in fluid communication with the flow channel of the module housing of the pump, the sensors being configured to measure a pump operating parameter or a physiological condition of the patient based on information detected about the passage of fluid through the flow channel.
[0068] [0068] Clause 48: System, according to claims 38, 39, 40, 41, 42, 43, 44, 45, 46 or 47, characterized by the fact that the remote control device further comprises a screen and in which the remote control device is configured to display information received from the control module about at least one between the pump module or the patient on the display.
[0069] [0069] Clause 49: Method for treating a patient, providing negative pressure therapy to a portion of the patient's urinary tract, characterized by the fact that the method comprises: positioning a pump assembly comprising: (a) a pump module, wherein at least a portion of the pump module is configured to be positioned within at least one inner part of a ureter, an inner part of a renal pelvis, an inner part of a bladder or an inner part of a patient's urethra to provide negative pressure to at least one ureter or kidney of the patient, the pump module comprising: a housing comprising an open proximal end, an open distal end and a side wall that extends defining a flow channel for conducting fluid through at least one internal portion of the patient's ureter, an internal portion of the patient's renal pelvis, an internal portion of the patient's bladder or an internal portion of the patient's urethra, at least a portion of the housing is configured to be positioned within at least an inner portion of the ureter, an inner portion of the renal pelvis, an inner portion of the bladder or an inner portion of a patient's urethra; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the flow rate of the fluid passing through the channel, the control module comprising a configured housing to be positioned within at least a second inner portion of the patient's ureter, a second inner portion of the patient's renal pelvis, a second inner portion of the patient's bladder or a second inner portion of the patient's urethra; and activating the pump module, causing the pump module to draw fluid through its channel to supply negative pressure to a portion of the patient's urinary tract.
[0070] [0070] Clause 50: Method, according to claim 49, characterized by the fact that the control module housing is dimensioned for insertion in the patient's bladder and in which the maximum external diameter of the pump module is smaller than the diameter maximum external of the control module.
[0071] [0071] Clause 51: Method, according to claims 49 or 50, characterized by the fact that the set is implanted within a portion of the patient's bladder and / or ureter using a catheter.
[0072] [0072] Clause 52: Method, according to claims 49, 50 or 51, characterized by the fact that the positioning of the pump assembly also comprises implanting splinters against an internal wall of the bladder and / or ureter to maintain the positioning of the pump assembly inside the bladder and / or ureter.
[0073] [0073] Clause 53: Method, according to claims 49, 50, 51 or 52, characterized by the fact that the negative pressure is supplied in a range between 0 and about 150 mmHg.
[0074] [0074] Clause 54: Method, according to claims 49, 50, 51, 52 or 53, characterized by the fact that the activation of the pump module also comprises the periodic inversion of the pump direction for a period of time to supply intermittent positive pressure to the patient's urinary tract. Brief description of the drawings
[0075] [0075] These and other features and characteristics of the present disclosure, as well as the methods of operation, use and functions of the related elements of the structures and the combination of parts and manufacturing economies, will become more evident with consideration of the description below attached claims with reference to the attached drawings, all of which are part of this specification, in which equal reference numbers designate corresponding parts in the various figures. It should be expressly understood, however, that the drawings are for illustration and description purposes only and are not intended to be a definition of the limit of the invention.
[0076] [0076] Other resources and other examples and advantages will be evident from the following detailed description made with reference to the drawings, in which:
[0077] [0077] FIG. 1A is a schematic drawing of a patient's urinary tract showing a pump set positioned in the patient's ureter and bladder according to an example of the present disclosure;
[0078] [0078] FIG. 1B is an enlargement of a portion of FIG. 1A;
[0079] [0079] FIG. 1C is a schematic drawing of a patient's urinary tract showing a pump set positioned in the patient's renal pelvis and ureter according to another example of the present disclosure;
[0080] [0080] FIG. 1D is a schematic drawing of a patient's urinary tract showing a pump set positioned in the patient's bladder according to another example of the present disclosure;
[0081] [0081] Figs. 2A and 2B are schematic drawings of a pump assembly according to an example of the present disclosure;
[0082] [0082] FIG. 3 is a schematic drawing of a pump assembly including a wired connection between a pump module and a controller module thereof, according to an example of the present disclosure;
[0083] [0083] FIG. 4 is a schematic drawing of a pump assembly including anchor barbs that extend radially outwardly from a side wall thereof, according to an example of the present disclosure;
[0084] [0084] FIG. 5 is a schematic drawing of a pump assembly including spiral retaining barbs, according to an example of the present disclosure;
[0085] [0085] FIG. 6 is a schematic drawing of a pump set including an inlet conduit configured to be inserted into a patient's ureter, according to an example of the present disclosure;
[0086] [0086] FIG. 7 is a cross-sectional view of a portion of the pump assembly of FIGS. 2A and 2B taken along line 7-7;
[0087] [0087] FIG. 8 is a cross-sectional view of a portion of a pump assembly according to an example of the present disclosure;
[0088] [0088] FIG. 9 is a schematic drawing of a pump assembly including an implantable induction coil according to an example of the present disclosure;
[0089] [0089] FIG. 10 is a schematic drawing of the pump assembly of FIG. 9 implanted in a patient's urinary tract, according to an example of the present disclosure;
[0090] [0090] FIG. 11 is a schematic diagram of electronic components of the pump assembly of FIGS. 2A and 2B;
[0091] [0091] FIG. 12 is a schematic drawing of a system for inducing negative pressure in a patient's urinary tract comprising a pump assembly according to an example of the disclosure;
[0092] [0092] FIG. 13A is a schematic drawing of a delivery catheter for delivering a pump set to a portion of a patient's urinary tract, according to an example of the present disclosure;
[0093] [0093] FIG. 13B is a schematic drawing of the delivery catheter of FIG. 13A with portions of an elongated tube cut to show the pump assembly contained therein; and
[0094] [0094] FIG. 14 is a schematic drawing of a pump assembly including a pump module positioned on a patient's bladder according to an example of the present disclosure. Detailed Description
[0095] [0095] As used herein, the articles “o”, “a”, “um” and “uma” include plural referents, unless the context clearly states otherwise.
[0096] [0096] As used in this document, the terms "right", "left", "upper" and their derivatives are related to the invention, as outlined in the drawing figures. For a device or system, the term "proximal" refers to a part of the device or system closest to the access site through which the device or system is inserted into the body. For an internal urinary tract pump, the proximal portion is the portion of the device or system closest to the urethra. The term "distal" refers to the opposite end of a device or system from the proximal end and, for example, the portion of the device or system that is inserted farther into the patient's urinary tract. However, it should be understood that the invention can take several alternative orientations and, consequently, these terms should not be considered as limiting. In addition, it should be understood that the invention may assume several alternative variations and sequences of stages, except where the contrary is expressly 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, specific dimensions and other physical characteristics related to the modalities disclosed in this document should not be considered as limiting.
[0097] [0097] For the purposes of this specification, unless otherwise specified, all numbers expressing quantities of ingredients, reaction conditions, dimensions, physical characteristics and so on used in the specification and claims must be understood as modified in all instances by term “fence”. Unless otherwise indicated, the numerical parameters set out in the following specification and the appended claims are approximations that may vary depending on the desired properties that are desired by the present invention. At a minimum, and not as an attempt to limit the application of the equivalence doctrine to the scope of the claims, each numerical parameter must at least be interpreted in light of the number of significant digits reported and applying common rounding techniques.
[0098] [0098] Notwithstanding the fact that the ranges and numerical parameters that establish the broad scope of the invention are approximations, the numerical values established in the specific examples are reported as accurately as possible. Numeric values can inherently contain certain errors resulting from a standard deviation found in their respective test measurements.
[0099] [0099] In addition, it should be understood that any numerical range mentioned here is intended to include all the subintervals included therein. For example, a range from “1 to 10” is intended to include any sub-intervals between and including the minimum mentioned value of 1 and the maximum recited value of 10, that is, all sub-intervals starting with a minimum value equal to or greater than 1 and ending with a maximum value equal to or less than 10 and all sub-intervals between, for example, 1 and 6.3, or 5.5 and 10 or 2.7 and 6.1.
[0100] [0100] As used in this document, the terms "communication" and "communicates" refer to the receipt or transfer of one or more signals, messages, commands or other data. The fact that a unit or component is in communication with another unit or component means that a unit or component is capable of receiving data directly and indirectly from and / or transmitting data to the other unit or component. This can refer to a direct or indirect connection that can be wired and / or wireless in nature. In addition, two units or components can be in communication with each other, even though the transmitted data can be modified, processed, routed and similar between the first and the second unit or component. For example, a first unit may be in communication with a second unit, even if the first unit passively receives data and does not actively transmit data to the second unit. As another example, a first unit can be in communication with a second unit if an intermediate unit processes data from one unit and transmits processed data to the second unit. It will be appreciated that several other arrangements are possible.
[0101] [0101] Generally, the pump assemblies, systems and methods of the present disclosure can be used to introduce negative pressure or positive pressure into at least a portion of the patient's urinary tract to establish a desirable pressure gradient or pressure differential through the filtration anatomy of the nephron, for example, glomerulus, proximal tubules and distal tubules. In some instances, the sets of pumps, systems and methods of the present disclosure can be used to provide negative pressure therapy or positive pressure therapy for the treatment of medical conditions, such as acute or chronic treatment of venous congestion resulting from, for example, insufficiency cardiac arrest, sepsis, burns and other primary morbidities that affect renal pressure gradients and nephron filtration. Systems for providing negative pressure therapy are also disclosed in International Publication No. WO 2017/015351 entitled "Ureter and Bladder Catheters and Methods to Induce Negative Pressure and Increase Renal Perfusion" and in International Publication No. WO 2017/015345 entitled “Catheter Device and Method to Induce Negative Pressure in a Patient's Bladder”, each of which is incorporated here in its entirety for reference purposes.
[0102] [0102] In some examples, the pump sets, systems and methods disclosed herein can be used to treat and / or control fluid retention and venous congestion, which can contribute to conditions such as heart disease, acute kidney injury and insufficiency renal. For example, fluid retention and venous congestion are central problems in the progression to advanced renal dysfunction. Excessive sodium intake, associated with relative reductions in excretion, leads to expansion of isotonic volume and involvement of the secondary compartment. Although this document is not intended to be linked to a single specific theory, it is believed that the application of negative pressure to the bladder, ureter and / or kidneys may compensate for the reabsorption of sodium and water by the medullary tubule of the nephron in some situations. Compensating for the reabsorption of sodium and water can increase urine production, decrease total body sodium and improve erythrocyte production. As intramedullary pressures are triggered by sodium and, therefore, by volume overload, the intended removal of excess sodium allows the maintenance of volume loss. Removing the volume restores medullary hemostasis. Normal urine output is 1.48-1.96 L / day (or 1-1.4 ml / min).
[0103] [0103] Fluid retention and venous congestion are also central problems in the progression of acute prerenal kidney injury (AKI). Specifically, AKI may be related to loss of perfusion or blood flow through the kidneys. Therefore, in some examples, the present invention facilitates the improvement of renal hemodynamics and increases urine production in order to relieve or reduce venous congestion. In addition, treatment and / or inhibition of AKI is expected to positively impact and / or reduce the occurrence of other conditions, for example, reduction or inhibition of worsening renal function in patients with class III and / or class heart failure NYHA IV. The classification of the different levels of heart failure is described in The Criteria Committee of the New York Heart Association, (1994), Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels, (9th ed.), Boston: Little, Brown & Co. pp. 253–256, the disclosure of which is incorporated herein in full for reference purposes. The reduction or inhibition of AKI episodes and / or chronically reduced perfusion can also be a treatment for Stage 4 or Stage 5 chronic kidney dysfunction. Progression of chronic kidney dysfunction is described in the National Kidney Foundation, K / DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification. Am. J. Kidney Dis. 39: S1-S266, 2002 (Suppl. 1), the disclosure of which is incorporated herein in its entirety for reference purposes.
[0104] [0104] Referring now to FIG. 1, a pump or pump set according to the present disclosure is disclosed herein which is configured or adapted to be placed within a patient's urinary tract.
[0105] [0105] Referring now to Figs 1A-D and 2A-2B, in some examples, the pump set, usually indicated at 100, comprises a pump module 110. At least a portion of the pump module 110 is configured to be positioned within at least an inner portion 28, 30 of a ureter 8, 10, an inner portion 32, 34 of a renal pelvis 14, 16, an inner portion 40 of a bladder 12 or an inner portion of an urethra 18 of a patient. For example, pump module 110 can be configured to be positioned in a proximal 11 or distal 9 portion of a patient's ureter 8, 10 and / or renal pelvis 14, 16. Pump module 110 can be used to deliver negative or positive pressure, as desired, to at least one of the patient's ureters 8, 10 or 4, 6 kidneys.
[0106] [0106] An exemplary pump assembly 100 is shown in FIGS. 2A and 2B. The pump assembly 100 comprises a pump module 110 configured to be positioned within an inner portion 28, 30 (e.g., a proximal portion 11 or distal portion 9) of a ureter 8, 10 and / or an inner portion 32, 34 from a renal pelvis 14, 16 from a patient for providing negative or positive pressure to the patient's ureter and / or kidney and a control module 112 configured to be implanted and / or implanted in a portion of the ureter 8, 10 and / or renal pelvis 14, 16 or, for example, in other parts of a patient's urinary tract, for example, in the bladder 12 or in the urethra 18.
[0107] [0107] In some examples, pump module 110 comprises housing 114. At least a portion of housing 114 is configured to be positioned within an inner portion 28, 30 of ureter 8, 10, an inner portion 32, 34 of the renal pelvis 14, 16, an inner portion 40 of the bladder 12, or an inner portion of the urethra 18. Housing 114 comprises an open proximal end 116, an open distal end 118 and a side wall 120 extending between them, which defines a flow channel 122 to conduct fluid F1 through the inner portion 28, 30 of the patient's ureter 8, 10, the inner portion 32, 34 of the renal pelvis 14, 16, the inner portion of the bladder 12 or the inner portion of the patient's urethra 18 (depending on where the pump module is positioned) and move the fluid into or through the patient's bladder 12 or urethra 18 out of the patient. Housing 114 may be formed from one or more suitable biocompatible materials, such as medical grade plastic (for example, high density polyethylene, polycarbonates and silicone materials) and / or metal (for example, stainless steel).
[0108] [0108] In some examples, housing 114 has a maximum outside diameter D1 of about 0.5 mm to about 3.0 mm or about 2.0 mm to about 2.5 mm. The outer diameter D1 can be selected to correspond to an average inner diameter of the ureter, so that the pump module 110 fits perfectly within the ureter.
[0109] [0109] In some instances, pump module 110 may at least partially seal the ureter to inhibit leakage of urine and / or to maintain negative pressure. In some instances, the external cross section of housing 114 of pump module 110 can be sized to fill the internal cross section of the ureter. The engagement of the ureter tissue with the housing 114 closes the ureter at least partially to inhibit leakage of urine diversion and / or to maintain negative pressure. In one example, the housing may be substantially cylindrical and the outer diameter of housing 114 may be equal to or greater than the inner diameter of the ureter. In some examples, as shown in Fig. 2B, to facilitate the formation of a suitable seal, a flexible and / or resilient elastomeric structure can be positioned around an external portion of the pump module to seal the ureter at least partially. For example, an annular seal 124 that extends around the outer surface 121 of the circumference of the side wall 120 of the pump module 110 can be attached or positioned around a portion of the pump module 110 to form a seal between housing 114 and the adjacent inner wall 13 of the ureter 8,
[0110] [0110] Housing 114 can be configured as desired to facilitate placement within the ureter, renal pelvis, bladder or urethra and to accommodate the pump element (discussed below) and the flow channel. In some examples, housing 114 is a substantially cylindrical structure with substantially similar annular cross sections along its entire length. Housing 114 may have a diameter ranging from about 3 mm to about
[0111] [0111] As discussed in more detail below, to induce negative or positive pressure, the pump module 110 comprises a pump element or mechanism 126 (shown in Fig. 2B) which, while positioned within an inner portion 28, 30 of the ureter 8, 10, an inner portion 32, 34 of the renal pelvis 14, 16, an inner portion 40 of the bladder 12 or an inner portion of the urethra 18, is continuously or periodically activated to attract fluid to a flow channel 122 of the pump 110, thereby inducing negative or positive pressure in ureters 8, 10 and / or kidneys 4, 6. Pump element 126 can be at least partially positioned within channel 122, so that, when activated, it attracts fluid through the channel 122 between the open distal end 118 and the open proximal end 116 of the housing in the direction of arrow A1. The pump element 126 can operate for a predetermined period of time, for example, during a certain period every day, or it can operate continuously. The operating time of the pump may vary as desired. Pump element 126 may include different types of molded or machined parts, as are known in the art, including impellers, screw threads, pistons, one-way valves, check valves and similar structures for pulling fluid through the pump module, as will be be described here. In some examples, the pump element 126 comprises a piezoelectric film or surface which transitions from an extended configuration to a retracted configuration to draw fluid through the pump, as described below.
[0112] [0112] When activated, the pump module 110 draws fluid F1 (for example, urine) from kidneys 4, 6 and ureters 8, 10 and moves fluid F1 to bladder 12 or through the bladder out of the patient, thus inducing negative pressure in the urinary tract. The rotation or actuation of the pump element 126 can be reversed to provide positive pressure as needed.
[0113] [0113] In some examples, the F1 fluid is expelled by the pump module 110 to the bladder 12. In other examples, the F1 fluid can be conducted through an outlet line 158, like a tube or conduit, through the interior of the urethra 18 and out of the body. F1 fluid can be collected in a fluid collection container (not shown) located outside the patient's body. The pump module can be configured to provide negative pressure in the range of 0 to about 150 mmHg, or about 5 mmHg to about 100 mmHg, or about 10 mmHg to about 50 mmHg. The pump module can be configured to intermittently deliver positive pressure in a range of about 0 to about 150 mmHg, or about 1 mmHg to about 100 mmHg, or about 1 mmHg to about 50 mmHg. Pump module 110 can be configured to provide a volumetric fluid flow rate between 0 and about 3.5 ml / min, between about 0.2 ml / min and about 2.5 ml / min, or between about 0.4 ml / min and about 1.25 ml / min. Generally, the amount of negative or positive pressure provided by the pump and / or volumetric flow is determined from the pump's operating parameters (for example, the pump module is configured to provide a predetermined negative pressure or draw fluid at a predetermined flow) . However, in some instances, the pump module may comprise pressure sensors to directly or indirectly measure the negative and / or positive pressure exerted on the ureter and / or kidneys by the pump module and / or flow rate sensors to measure the volume of fluid extracted by the pump module. As described herein, negative or positive pressure can be applied pulsed continuously or intermittently to trigger continuous or pulsatile flow.
[0114] [0114] As described herein, pump element 126 can be, for example, a microelectric mechanical component, as is known in the art, for example, an Abiomed® Impella® pump or a piezoelectric pump, such as those manufactured by Dolomite. Other manufacturing techniques for producing components of a pump module 110 configured for insertion into the ureter 8, 10, renal pelvis 14, 16 or urethra 18 may comprise, for example, injection molding, three-dimensional printing, metal stamping and manufacturing techniques similar, as are known in the art. For example, as shown in FIGS. 7 and 8, the pump element 126 can comprise an impeller 1 and / or a deformable, movable and / or expandable piezoelectric element 180. As described in more detail below in relation to FIG. 11, in some examples, the pump element 126 can be operationally connected to electrical components, including a motor (for example, drive mechanism 228), a power source (for example, battery 226 and / or induction coil 210) and an on / off switch or controller 218, as well as different types of optional sensors to measure the operating parameters of the pump and / or physiological information for the patient, as discussed below. Pump element and associated electrical components
[0115] [0115] Exemplary embodiments of the pump element 126 of the pump module 110 are shown in FIGS. 7 and
[0116] [0116] As shown in FIG. 7, in some instances, pump element 126 comprises a rotary impeller 170 positioned within channel 122. Impeller 170 can be made of various medical grade materials that are strong and rigid enough to rotate for an extended period without deforming or bending .
[0117] [0117] As shown in FIG. 8, another exemplary pump element 126 comprises a piezoelectric diaphragm 180 configured to transition between a contracted position (shown by dashed lines in FIG. 8) and an expanded position (shown by solid lines in FIG. 8), in which the piezoelectric diaphragm 180 expands into channel 122 to restrict flow through channel 122 and reduce the volume and cross-sectional area of channel 122. piezoelectric diaphragm 180 can be formed from a thin flexible conductive film, such as a polymer and / or elastomeric film, as is known in the art, or stainless steel.
[0118] [0118] During operation, the fluid is sucked into channel 122 through a distal valve 182 by deflation of the piezoelectric diaphragm 180, as shown by arrow A1 in FIG. 8. For example, a flap 188 of distal valve 182 can rotate in the direction of arrow A3 to an open position to allow fluid to pass through it. As a result of the negative pressure produced by deflation or collapse of diaphragm 180, proximal valve 184 is forced to close to prevent fluid from refluxing. Once diaphragm 180 is emptied or collapsed by a predetermined amount, the movement of diaphragm 180 is reversed by applying the electrical signal to the conductive film. As diaphragm 180 expands, distal valve 182 closes to prevent fluid from refluxing and fluid is expelled from channel 122 through open proximal valve 184 through open proximal end 116 of the housing, in the lower portion of the ureter 11 and through the urethra 18. Control module
[0119] [0119] The pump set 100 further comprises a control module 112 configured to be positioned within at least a second internal portion of the patient's ureter 8, 10, a second internal portion of the patient's renal pelvis 14, 16, a second internal portion of the patient's bladder 12 or a second internal portion of the patient's urethra. As the term is used in this document, a module can refer to a device communicating with or wirelessly with one or more other modules or devices, thus forming a patient care system. In some examples, modules can be part of a single device or set or multiple devices or sets and, for example, can be placed in a single device compartment or in multiple housings. In other examples, a module refers to the processing circuit that executes instructions and executes functions based on the instructions executed. In this case, the same processing components can perform functions from different modules. For example, a single controller or microprocessor can be configured to perform both functions of pump module 110, including operating and terminating a pump element or mechanism 126, and control module 112, how to receive and process data transmitted from remote devices.
[0120] [0120] In some examples, the control module comprises electronic circuits, such as a controller or microprocessor comprising computer-readable memory, comprising instructions that, when executed, control the pump's operating parameters (for example, flow, operating speed, duration of the pump) operation etc.). For example, the controller or processor can be configured to send instructions to the pump module to make the module switch on, off, or adjust the operating speed. The control module can also comprise one or more communication interfaces to communicate instructions to the pump module and to communicate information about the treatment provided to the patient and the patient's measured parameters to a remote device or data collection facility. For example, the communication interface can be configured to wirelessly transmit data about a patient or treatment provided to a patient to a patient care facility for inclusion in a patient's medical record.
[0121] [0121] Pump module 110 and control module 112 can be integrally formed or connected directly, as shown, for example, in FIGS. 2A and 2B. In other examples, the separate pump and control modules can be connected wirelessly or wired, as shown in FIG. 3. In some examples, the wires extending between the pump module and the control module may extend a substantial portion of the length of the ureter, so that the pump module can be positioned within the region of the renal pelvis and the module control can be positioned on the patient's bladder. In other examples, the pump module can be in wireless communication with the control module, which can be spaced from the pump module. For example, a remote control device 310, such as a device positioned outside the patient's body, can be used to control the pump module 110.
[0122] [0122] Control module 112 is operationally connected and / or in communication with the components of pump module 110, including pump element 126 to direct the movement of pump element 126 to control the flow rate of fluid F1 that it passes through the patient's inner ureter 8, 10, the patient's renal pelvis, the patient's bladder 12 or the patient's urethra 18.
[0123] [0123] In some examples, control module 112 comprises a housing 128. At least a portion of housing 128 is configured to be positioned within the inner portion 28, 30 of the ureter 8, 10, the inner portion 32, 34 of the pelvis kidney 14, 16, the inner portion of the bladder 12,
[0124] [0124] Control module housing 128 can be configured as desired to facilitate placement within the ureter, renal pelvis 14, 16, bladder 12 or urethra 18 and to accommodate the control module and flow channel ( if present). In some instances, the control module housing 128 is a substantially cylindrical structure with substantially similar annular cross sections along its entire length. In other examples, the control module housing 114 can be tapered to facilitate the positioning of the distal parts of the control module housing 128 within the ureters 8, 10, bladder 12 or urethra 18. For example, a taper of about 0 at about 6 degrees can be used. In other examples, the control module housing 128 may have a non-circular cross section. For example, the cross section of the control module housing 128 can be a square, rectangle or other polygonal shape.
[0125] [0125] In some examples, the control module housing 128 is a generally cylindrical structure. The control module housing 128 can optionally comprise a flow channel 136 therethrough. Flow channel 136 can have an internal diameter ranging from about 1 mm to about 6 mm or about 2 mm to about 5 mm. The shape of the interior of the flow channel 136 can be of any desired shape and, in some examples, can be generally cylindrical to facilitate flow through it. The control module housing 128 may be formed of a biocompatible metal or plastic material similar to the pump module 114 housing described above. In general, the maximum outside diameter D2 may be sufficient to position the control module 112 within a patient's bladder and, as such, it may be larger than the diameter of the ureteral orifice 24, 26 (shown in FIG. 1) and the inner diameter of the ureter so that the control module 112 remains in the bladder and is not pulled into the ureter along with the pump module 110.
[0126] [0126] The control module 112 further comprises electronic circuits to operate the pump element 126, including components to control and adjust the pump flow rate, generated negative and / or positive pressure, energy use and other operational parameters. Examples of electronic components from pump assembly 100, including control module 112, are shown in FIG. 11 and are described in detail below.
[0127] [0127] As shown in FIGS. 2A and 2B, in some examples, the pump module 110 and the control module 112 can be integrally formed, so that the respective housings 114, 128 are connected directly to each other. For example, as shown in FIGS. 2A and 2B, the proximal end 116 of the pump module 110 is connected and / or formed integrally with the distal end 132 of the control module 112. In this case, the channel 122 of the pump module 110 is directly connected and in fluid communication with channel 136 of control module 112, so that fluid F1 is withdrawn from ureter 8, 10, renal pelvis 14, 16, bladder 12 or urethra 18 through flow channel 122 of pump module 110 and the flow channel 136 of the control module 112 is ejected from the open proximal end 130 of the control module 112 into the patient's bladder or through tubing to conduct fluid through the bladder 12 and urethra 18 out of the patient's body.
[0128] [0128] As shown in FIG. 3, in another example of a pump assembly 100, the control module housing 128 is separate from the pump module housing 114. In that case, as shown in FIG. 3, the respective modules 110, 112 are connected via wireless or wired connection formed by one or more wires 138 that extend between the respective modules 110, 112. In some examples, wires 138 are covered with a sheath or biocompatible coating suitable to provide adequate insulation and to facilitate the insertion and / or removal of urinary tract 138. For example, polymer coatings such as polyvinyl chloride, polytetrafluoroethylene (PTFE), latex or silicone can be used. In this example, the control module housing can optionally include flow channel 136.
[0129] [0129] Wires 138 can be configured to conduct electronic signals between modules 110, 112, including, for example, operating instructions from control module 112 to pump element 126 of pump module 110 to control or adjust speed and / or to start or stop the operation of the pump element. Operating parameters and / or information detected by the electronic components of the pump module 110 can be transmitted to the control module 112 via the wired connection for processing, analysis and / or be transmitted from the control module 112 to a remote source. In some examples, the wires 138 between the respective modules 110, 112 are of very short length, which means that the pump module 110 is configured to be positioned in a proximal portion of the ureter 8, 10, close to the ureteral orifice 24, 26 in the bladder 12. In other configurations, the wires 138 are the length of the ureter, which means that the pump module 110 can be positioned in the renal pelvis 14, 16 and / or kidney 4, 6, while the control module 112 can be positioned in the ureter 8, 10 and / or in the bladder 12. For example, the strands 138 can have an L1 length of about 1 cm to about 35 cm, or about 15 cm to about 25 cm, once that the average length of an adult’s ureter is about 25 cm to about 30 cm. Power supply
[0130] [0130] In some examples, control module 112 further comprises an internal or external power source 200 to supply power to the electronic circuit of control module 112 and pump element 126 or pump module mechanism 110. The power source it can be a disposable or rechargeable battery, which, in some examples, can be recharged, for example, using inductive energy transfer through a small induction coil implanted, for example, in the bladder. The induction coil can be configured to generate energy when exposed to an electromagnetic field generated by a remote device outside the patient's body. For example, the remote device can be a computerized device, such as a smartphone or tablet. In other examples, the remote device may be a non-computerized device, including circuits to generate the electromagnetic field. In one example, a blanket including electromagnetic circuits that generate the field can be wrapped around the patient while he sleeps. The field generation circuit can induce the coil to generate power for the entire night or at least until the rechargeable battery is fully charged. Since the patient is less likely to move while sleeping than when awake, it is likely that the portion of the blanket that produces the electromagnetic field will remain very close to the pump assembly for a substantial period of time.
[0131] [0131] In some examples, the pump assembly 100 further comprises a power source 200, as shown in FIGS. 9 and 10, comprising an induction coil 210 electronically coupled to the pump module 110 and / or to the control module 112. Induction coils for wireless near-field energy transfer are known and are used, for example, to charge low-power portable electronic devices such as cell phones, notebooks, small appliances and power tools. An exemplary induction coil is the eCoupled system developed by Fulton Innovation, which is described, for example, in U.S. Patent No.
[0132] [0132] As described here, induction coil 210 generates and supplies power to pump assembly 100 to operate pump module 110 and control module 112. For example, the energy produced by induction coil 210 can be used to recharge a rechargeable battery to supply power to sensors disposed in the pump module 110 and / or for wireless data transmission between the pump assembly 100 and external devices. In some examples, as discussed here, induction coil 210 generates energy when exposed to an electromagnetic field produced by another device. For example, the electromagnetic field can be generated by a remote control device 310 (shown in FIG. 12) positioned outside the patient's body. The remote control device 310 can be used in a case, carrying bag, backpack or pocket, for example, and positioned so that the remote device is kept flat against the body and as close as possible to the induction coil 210.
[0133] [0133] In some examples, shown in FIGS. 9 and 10, the induction coil 210 comprises a flexible sheet 212, such as a polymer sheet, and a conductive wire 214 incorporated or attached to flexible sheet 212. For example, wire 214 can be attached to flexible sheet 212 in a spiral, zigzag or any other suitable pattern. Induction coil 210 can be connected to pump assembly 110 by one or more wires or cables 216. For example, coil 210 can be connected to control module 112 via cables 216 extending from the proximal end 130 of the control module 112.
[0134] [0134] In some examples, flexible sheet 212 may change from a rolled-up configuration 234 (as shown in FIG. 13B) to an unrolled or implanted configuration 236 (shown in FIGS. 9 and 10). In some cases, flexible sheet 212 can be configured to be deployed automatically. For example, sheet 212 can be angled to unroll naturally when it is released from an implantation catheter 410 (shown in FIGS. 13A and 13B). In other examples, coil 210 may include a manual release mechanism, such as a release button or a trigger wire. When a user presses the release button or pulls the trigger wire, a locking mechanism for keeping coil 210 in the rolled configuration allows flexible sheet 212 to unwind, thus making the transition from sheet 212 to the implemented configuration.
[0135] [0135] Induction coil 210 can be positioned in any convenient position within patient 2's urinary tract. For example, as shown in FIG. 10, the induction coil 210 can be operationally connected to the control module 112 and is positioned on the patient's bladder 12 in a position proximal to the control module 112. Alternatively, the induction coil 210 can be positioned in the abdominal cavity, outside the bladder, in the peritoneal cavity, in any other convenient location in vivo or external to the patient.
[0136] [0136] Examples of electronic components of pump assembly 100 are shown in the schematic diagram of FIG. 11. As previously described, pump assembly 100 comprises pump module 110, control module 112 and power source, such as induction coil 210 or battery 226 (shown in FIG. 11). Induction coil 210 can be operationally coupled to control module 112 by cables 216 to supply power to control module 112.
[0137] [0137] Control module 112 comprises a controller 218 and a transient or non-transitory computer-readable memory 220. Controller 218 may comprise, for example, one or more general purpose microprocessors configured to receive and implement pump operating instructions. , for example, communicating with the pump module 110 to trigger or interrupt the operation of the pump element 126 and / or adjust an operating speed to control the negative and / or positive pressure delivered to the patient.
[0138] [0138] In some examples, controller 218 can be configured to control communication between pump set 100 and one or more remote control devices 310 located external to the patient. In that case, the control module 112 may further comprise a communication interface 222 comprising, for example, a wireless transmitter or antenna. The communication interface 222 can be configured to receive instructions from a remote source (e.g., remote control device 310) and to emit signals that control the operation of the pump element based on the instructions received.
[0139] [0139] Control module 112 further comprises power distribution and management circuits 224. As shown in FIG. 11, the power management circuit is electrically coupled to the induction coil 210. The energy distribution circuit 224 can be configured to receive energy generated by the induction coil 210 and to control the distribution of the generated energy to other components of the system.
[0140] [0140] In some examples, control module 112 may further comprise a battery 226, such as a rechargeable battery, functionally connected to controller 218 and power distribution circuit 224. Battery 226 can be recharged from the energy generated by the coil induction coil 210. Sometimes when power is not being generated by induction coil 210, system components can continue to operate on the power supplied by battery 226. Battery 226 can be any battery small enough to fit in the battery compartment. control module 128 and which has been approved for in vivo use. For example, batteries used in pacemakers and similar implanted devices may be suitable for use with the pump set 100 described herein.
[0141] [0141] As previously described, the electronic components of control module 112, including controller 218, are in electronic communication with the electrical components of pump module 110 through, for example, connection wires 138 (shown in FIGS. 3 , 9 and 11) or other suitable electronic connection. The power generated by the induction coil 210 can be supplied to the electronic components of the pump module 110 via wires 138. In addition, operating instructions generated by the controller 218 can be supplied to the components of the pump module 110 to control the operating parameters of the bomb. Similarly, information collected or generated by pump module components 110 can be communicated to controller 218 for further processing and / or transmitted wirelessly to a remote device.
[0142] [0142] As shown in FIG. 11, pump module 110 comprises pump element 126 and associated electronic components. For example, pump module 110 may comprise a drive mechanism 228, such as an electric motor or signal generator, operationally connected to pump element 126. A variety of different drive mechanisms can be used in connection with the pump module 110, depending on the type of pump element 126 being used. For example, for an impeller-type pump arrangement (as shown in FIG. 7), the drive mechanism 228 may comprise an electric motor that causes the impeller to rotate. In other examples, the drive mechanism 228 may comprise electromagnetic elements arranged around the impeller 170, which turn on and off in a predetermined pattern to cause the impeller to rotate at the desired speed. If the pump element 126 is a piezoelectric element 180, the drive mechanism 228 may comprise a signal generator for generating electrical current to transition the piezoelectric element between the contracted and expanded states.
[0143] [0143] In some examples, pump module 110 may further comprise one or more sensors (for example, pump sensors 230 and physiological sensors 232) positioned within flow channel 122 of pump module 110 to measure information about conditions of pump operation and / or over the passage of fluid through channel 122. For example, pump sensors 230 may comprise flow sensors to confirm that fluid is passing through channel 122 and / or to measure the flow rate. The sensors of the pump 230 may also comprise sensors for measuring an amount of negative and / or positive pressure generated or a speed of rotation of the pump impeller. Physiological sensors 232 may comprise one or more sensors for measuring information about the passage of fluid through channel 122 to determine information about the patient's physiological condition. Exemplary physiological sensors 232 may comprise, for example, capacitance sensors and / or analytes for measuring information representative of the chemical composition of the generated urine, pH sensors for measuring urine acidity or temperature sensors for measuring urine temperature. Retention members
[0144] [0144] In some examples, and as shown in FIG. 4, the pump assembly 100 may further comprise one or more retaining members, for example, retaining barbs 140 and / or spiral barbs 144, to maintain the position of the pump module 110 and / or control module 112 within the patient's urinary tract 2. In some instances, the pump module housing 114 and / or the control module housing 128 comprises one or more retaining members that extend from the side wall to loosely secure a portion of the housing the pump module 114 to at least an inner portion of the ureter, inner portion of the renal pelvis,
[0145] [0145] In some examples, retaining members or retaining barbs 140, 144 can be formed in any suitable pattern or arrangement, including straight edges, curved edges, sharp protrusions, hooks and combinations thereof. For example, retaining barbs 140 can be implantable and retractable. In that case, splinters 140 may be in a stowed position when pump assembly 100 is being advanced through the urinary tract. Once the pump assembly 100 is advanced to the desired position, splinters 140 are implanted to engage parts of the ureter, renal pelvis, bladder or urethral wall to hold pump assembly 100 in the desired position. For example, as shown in FIG. 4, an exemplary pump assembly 100 comprises one or more barbs 140 that extend radially out of the side wall 120 of the pump module 110. The barbs 140 can be flat so that barbs 140 can be compressed against the side wall 120 of the pump housing 114 of pump module 110 to disengage tissue from the ureter, renal pelvis, bladder or urethra during removal of pump assembly 100. Alternatively, barbs 140 may have any suitable cross-sectional shape or shape, including a triangle, circle , semicircle, rectangle, trapezoid or polygon. The barbs 140 can have a longitudinal length L2 that can be at least about 0.25 mm or at least about 0.45 mm and can be up to about 3.0 mm, up to about 2.5 mm or up to about 1.5 mm. The barbs 140 can have a width or diameter of about 1.0 mm or less, about 0.8 mm or less or about 0.5 mm or less. Before insertion, the barbs 140 can extend a maximum distance from the side wall 120 of the pump module 110 to a distance of about 1.0 mm or less, about 0.8 mm or less or about 0.5 mm or less. The barbs 140 can be formed from a semi-rigid or rigid material suitable for maintaining the positioning of the pump module 110 in the urinary tract. For example, barbs 140 can be formed of metal (e.g., surgical stainless steel) or plastic. The splinters 140 may comprise a sharp tip 142 to press and lightly invade the ureter, renal pelvis, bladder or urethral wall to maintain the position of the pump module 110, without perforating the urethral wall. The thickness of the urethral wall is about 0.05 mm to 0.1 mm, so that the tips 142 of the splinters 140 must invade the ureter, renal pelvis, bladder or wall of the urethra to a lesser extent.
[0146] [0146] In some examples, barbs 140 are retractable. For example, splinters 140 can be tilted radially outward towards the ureter, renal pelvis, bladder or urethral wall, but configured to retract against side wall 120 of pump module housing 114 when pump assembly 100 is being advanced through an implantation catheter and into the patient's ureter, renal pelvis, bladder or urethra. Once they reach an implanted position, the barbs 140 can be configured to extend radially outwardly to an implanted configuration, as shown in FIG. 4. In other examples, barbs 140 can be extended or retracted by a manually activated drive mechanism. For example, a user can press a retract button or pull a drive wire to remove a radial deflection force from barbs 140 to cause barbs 140 to retract. After the retraction of barbs 140, the pump assembly 100 can be safely and easily removed from the urinary tract. For example, pump module 110 and control module 112 can be removed through the bladder and urethral sphincter and then through the body through the urethra.
[0147] [0147] In some examples, control module 112 comprises one or more members or retaining bars 144 to anchor or retain the control module to an inner surface of the bladder wall, in addition to or in place of the retaining members on the module pump. Barbs 144 may be similar to those discussed above for barbs 140. For example, as shown in FIG. 5, retaining barbs 144, like spiral retaining barbs, extend in the distal direction D of the distal end 132 of the control module 112. When positioned in the bladder 12, the barbs 144 are configured to engage parts 27 of the wall of the control bladder 15 around the ureter orifice 24, 26 to secure control module 112 to the bladder wall 15. For example, barbs 144, such as spiral retaining barbs, can engage the bladder wall with a twisting maneuver in the direction shown by arrow A2 (shown in figure 5). Spiral barbs 144 can be removed from the bladder wall by twisting control module 112 in an opposite direction, as shown by arrow A3. In some instances, spiral barbs 144 may be retractable. In this case, a user can advance the pump assembly 100 into the urinary tract with the proximal end of the control module 112 in contact with the bladder wall. Once the control module 112 is positioned, the user distributes barbs 144 so that barbs 144 are incorporated into the bladder wall to maintain the positioning of control module 112 and / or pump module 110 within the urinary tract . Pump module with inlet line
[0148] [0148] In other examples, as shown in FIG. 6, the pump module 110 can be configured to be positioned in the patient's bladder 12 instead of the ureter 24, 26. In this case, the housing 114 may be large enough to also include electronic components of the control module, such as a computer processor and battery. In such a configuration, the pump assembly 100 may further comprise an inlet line 146 or drain lumen or channel extending from the pump module 110 to the patient's ureter 8, 10 and / or renal pelvis 14, 16.. For example, inlet line 146 may be a substantially tubular conduit comprising a proximal end 148 mounted on a fluid inlet port 150 of pump module 110 and a distal end 152 for placement in the ureter 8, 10 and / or renal pelvis 14, 16. In some examples, the inlet line 146 may have an outside diameter ranging from about 0.33 mm to about 3.0 mm or about 1.0 mm to 2.0 mm. In some instances, the inside diameter of the inlet line 146 can range from about 0.165 mm to about 2.39 mm, or from about 1.0 mm to about 2 mm, or from about 1.25 mm to about 1.75 mm. In one example, inlet line 146 has 6 Fr and has an outside diameter of 2.0 ± 0.1 mm. Inlet line 146 may be formed from one or more suitable biocompatible materials, such as conventional materials used for urinary tract catheters. Examples of such materials may comprise polyvinyl chloride, polytetrafluoroethylene (PTFE), such as Teflon®, silicone-coated latex and / or silicone.
[0149] [0149] In some instances, the inlet line 146 comprises a plurality of openings 147 or drainage holes that extend through a side wall to draw fluid from the ureter and / or kidney into an inner lumen or flow channel of the line 146 In other examples, portions of the inlet line 146 may be formed from a porous and / or water-absorbent material, such as a sponge, mesh, fabric fiber or similar material. In that case, the fluid can be sucked into the lumen or flow channel through the porous material.
[0150] [0150] In some examples, the distal end 152 of the inlet line 146 comprises a retaining portion, usually indicated at 154, to maintain the position of the inlet line 146 in a desired fluid collection position near or into the ureter 8, 10 and / or renal pelvis 14, 16. Non-limiting examples of suitable retention portions are disclosed in US patent application publication numbers 2017/0021128 and 2017/0021129 and in PCT international publication No. WO 2017/015345, each of which is incorporated herein as a reference in its entirety.
[0151] [0151] In some examples, the retention portion 154 is configured to be flexible and foldable to allow positioning of the retention portion 154 in the ureter and / or renal pelvis. The retaining portion 154 is preferably sufficiently collapsible to absorb the forces exerted on the entry line 146 and to prevent these forces from being transmitted to the ureters. For example, if the retaining portion 154 is pulled in the proximal direction P (shown in FIG. 6) toward the patient's bladder, the retaining portion 154 may be flexible enough to begin to unwind or be straightened, so that it can be straightened. be pulled through the ureter. Likewise, when the retention portion 154 can be reinserted in the renal pelvis or another suitable region within the ureter, it can be tilted to return to its implanted configuration.
[0152] [0152] In some examples, the retaining portion 154 is an integral part of the entry line 146. In that case, the retaining portion 154 can be formed by transmitting a bend or wave to the entry line 146 which is sized and configured to retain the retaining portion in a desired fluid collection location. Suitable folds or bobbins may include a ponytail bobbin, corkscrew bobbin and / or helical bobbin. For example, the retaining portion 154 may comprise one or more helical coils that extend radially and longitudinally configured to passively contact and retain the entry line 146 within the ureter 8, 10 near or within the renal pelvis 14, 16. In other examples, the retaining portion 154 is formed from a radially enlarged or conical portion of the inlet line 146. For example, the retaining portion 154 may further comprise a fluid collection portion, such as a conical inner surface. or funnel-shaped. In other examples, the retaining portion 154 may comprise a separate element connected and extending from the entry line 146.
[0153] [0153] Referring now to FIG. 6, exemplary holding portions 154 comprising a plurality of helical coils, such as one or more complete coils and one or more half or partial coils, are illustrated. The retaining portion 154 may be able to move between a contracted position and the implanted position with the plurality of helical coils. For example, a substantially straight guide wire may be inserted through the retaining portion 154 to maintain the retaining portion 154 in a substantially straight contracted position. When the guide wire is removed, the retaining portion 154 can transition to its spiral configuration. In some examples, the coils 156 extend radially and longitudinally in the distal portion 152 of the inlet line 146. In some examples, the retaining portion 154 may comprise one or more coils 156, each coil having a sufficient coil outside diameter to contact at least a portion of the inner wall of the ureter and / or renal pelvis to maintain the entry line 146 in a desired position in the patient's ureter and / or renal pelvis.
[0154] [0154] In some examples, the spiral retaining portion comprises at least a first coil 160 having a first outer diameter 162; at least a second coil 164 having a second outer diameter 166, the first outer diameter 162 being smaller than the second outer diameter 166, the second coil 164 being closer to one end of the distal portion of the drain channel than the first coil 160 The first outer diameter 162 can range from about 12 mm to about 16 mm or about 13 mm to about 15 mm. The second outer diameter 166 can vary from about 16 mm to about 20 mm, or about 17 mm to about
[0155] [0155] In some examples, before insertion or after insertion into the patient's body, the central axis 190 of the retaining portion 154 may be coextensive with, generally parallel to curved or angled with respect to the central axis 192 of the flow channel of the drainage lumen. In some examples, at least a portion of the axis 190 of the retaining portion 154 extends at an angle 194 from the central axis 192 of 0 to about 90 degrees, or about 15 degrees to about 75 degrees, or about 45 degrees.
[0156] [0156] In some examples, before insertion into the patient's urinary tract, a portion of the drainage channel that is proximal to the retention portion defines a straight or curvilinear central axis, and in which, when implanted, the coils of the retention portion extend over the central axis 190 of the retaining portion 154 which is at least partially coextensive or coextensive with the straight or curvilinear central axis 192 of the flow channel portion 122.
[0157] [0157] In some examples, several coils 156 may have the same inner and / or outer diameter D and height H. In this case, the outer diameter 162, 166, 169 of the coils 156 can vary from about 10 mm to about 30 mm. The height H2 between the center line of each coil 156 can vary from about 3 mm to about 10 mm.
[0158] [0158] In some examples, the retaining portion 154 is configured to be inserted into the conical portion of the renal pelvis. For example, the outer diameter D of the coils 156 may increase towards the distal end 152 of the inlet line 146, resulting in a helical structure having a conical or partially conical configuration. For example, the distal or maximum 169 outer diameter of the conical helical portion ranges from about 10 mm to about 30 mm, which corresponds to the dimensions of the renal pelvis.
[0159] [0159] In some examples, the outer diameter 162, 166, 169 and / or the H2 height of the coils 156 can vary regularly or irregularly. For example, the outer diameter 162, 166, 169 of the coils or the height H2 between the coils can increase or decrease in a regular proportion (for example, about 10% to about 25% between adjacent coils 156). For example, for a retaining portion 154 with three coils (as shown, for example, in Fig. 6) an outer diameter 162 of a more proximal coil or first coil 160 can vary from about 6 mm to about 18 mm, an outer diameter 166 of an average coil or second coil 164 can range from about 8 mm to about 24 mm, and an outer diameter 169 of a more distal coil or third coil 168 can range from about 10 mm to about 30 mm mm.
[0160] [0160] Other non-limiting examples of suitable retention portions, such as funnel-shaped structures, inflatable or balloon structures, porous and / or spongy structures, and expandable cage structures are disclosed in U.S. Patent Application Publications No. 2017/0021128 and 2017/0021129 and PCT International Publication No. WO 2017/015345, incorporated by reference to this instrument. Some examples of suitable catheters, systems and methods of use are disclosed in U.S. Patent Application No. 15 / 687,064, entitled “Bladder and ureter catheters and negative pressure induction methods to increase renal perfusion”, presented on 25 August 2017, which is incorporated herein for reference purposes in its entirety.
[0161] [0161] Optionally, the retaining portion 154 may further comprise one or more perforations or drain holes 147 configured to draw fluid into the inlet line 146, for example, disposed on or through the side wall of the inlet line 146 in the or adjacent to the holding portion 154 to allow urine to flow from outside the inlet line 146 into the flow channel. The drain holes 147 can be positioned in a spaced arrangement along a side wall of the inlet line 146. In some examples, the retaining portion 154 may further comprise an additional hole at the distal end 152 of the retaining portion 154.
[0162] [0162] Drainage holes 147 can be located, for example, near the open distal end 152 of entry line 146. In other examples, perforated sections and / or drainage holes 147 are arranged along side wall 185 of the portion distal from inlet line 146. Drain holes 147 can be used to assist with fluid collection. In other examples, the retaining portion 154 is just a retaining structure and the collection of fluid and / or negative pressure is provided by structures at other locations on the inlet line 146.
[0163] [0163] In some examples, the retaining portion 154 of the inlet line 146 comprises a side wall 185 comprising a radially inward side 186 and a radially outward side 187, in which a total surface area of perforations or holes 147 on the radially inward side 186 is greater than a total surface area of perforations or holes 147 on the radially outward side 187. In some instances, the radially outwardly facing side 187 is essentially puncture free.
[0164] [0164] The configuration of the drain holes 147 can be any configuration that allows the passage of F1 fluid through them, whether this configuration is circular or non-circular. The position and size of the drain holes 147 may vary depending on the desired flow rate and the configuration of the retaining portion. The diameter of each of the drain holes 147 can vary from about 0.05 mm to 1.1 mm, about 0.7 mm to about 0.9 mm. The cross-sectional area of each drain hole 147 ranges from about 0.002 mm2 to about 1.0 mm2, or about 0.35 mm2 to about 0.65 mm2. The distance between adjacent drain holes 147, for example, the linear distance between drain holes 147 when the coils are straight, can vary from about 20 mm to about 25 mm, or about 21 mm to about 23 mm. The drain holes 147 can be spaced in any arrangement, for example, linear or offset. The total cross-sectional area of all drainage holes 147 can vary from about 0.002 mm2 to about 10 cm2, about 0.02 mm2 to about 8 cm2 or about 0.2 mm2 to about 5 cm2. In some examples, the drain holes 147 may be non-circular and may have a cross-sectional area of about 0.00002 mm2 to about 0.79 mm2 or about 0.02 mm2 to about 0.8 mm2.
[0165] [0165] In some examples, the drain holes 147 are located around the entire periphery of the sidewall of the inlet line 146 to increase the amount of fluid that can be attracted to the flow channel. In other examples, the drain holes 147 can be arranged essentially only on the side radially inward 186 of the coils 156 to prevent occlusion or blocking of the drain holes 147 and the side facing out 187 of the coils can be essentially free of holes drainage system 147. For example, when negative pressure is induced in the ureter and / or renal pelvis, the mucous tissue of the ureter and / or kidney can be pulled against the retention portion 154 and may obstruct some drainage holes 147 in the outer periphery of the retention portion 154. The drainage holes 147 located on the radially inner side of the retention structure would not be appreciably occluded when these tissues contact the outer periphery of the retention portion 154. In addition, the risk of damage to the tissues by pinching or contact with drain holes 147 it can be reduced or improved.
[0166] [0166] In some examples, the retaining portion 154 may include one or more mechanical stimulation devices to provide stimulation to the nerves and muscle fibers in the tissues adjacent to the ureters and renal pelvis. For example, mechanical stimulation devices may include linear or annular actuators embedded or mounted adjacent to parts of the side wall of the catheter tube 122 and configured to emit low levels of vibration. In some instances, mechanical stimulation may be provided to portions of the ureters and / or renal pelvis to complement or modify the therapeutic effects obtained by applying negative pressure. Although this document is not intended to be limited to a specific theory, it is believed that this stimulation affects adjacent tissues, for example, stimulating nerves and / or acting on peristaltic muscles associated with the ureters and / or renal pelvis. Stimulation of nerves and activation of muscles can produce changes in gradients or pressure levels in the surrounding tissues and organs, which can contribute or, in some cases, increase the therapeutic benefits of negative pressure therapy.
[0167] [0167] In some instances, the pump module 110 further comprises an outlet line 158 which extends from the pump module 110 to a portion of the patient's urinary tract 2. The outlet line 158 may be formed from a material similar and have dimensions similar to the entry line 146. The exit line 158 can extend from the bladder, through the urethral sphincter and the urethra, to a collection container external to the body. In some instances, the length of outlet line 158 can vary from about 30 cm to about 120 cm, depending on the patient's sex and age. Negative pressure therapy system
[0168] [0168] Referring now to FIG. 12, the pump assembly 100 may be a component of a negative pressure therapy or treatment system 300 to provide negative pressure therapy to a patient. The system 300 comprises the pump assembly 100 in communication with one or more computing devices positioned outside the patient's body to control the operation of the pump assembly 100 and to receive, process and analyze data generated by the components resident in the pump assembly 100 .
[0169] [0169] In some examples, as shown in FIG. 12, the system 300 comprises a remote control device 310 in wired or wireless communication with the control module 112 of the pump assembly 100. The remote control device 310 can be a dedicated electronic device configured to communicate with the assembly of the pump. pump 100. In other examples, remote control device 310 is a general purpose computer device configured to run software to communicate with and / or control the operation of pump set 100. For example, remote control device 310 may be a web-enabled computer device, such as a smartphone, tablet, or personal digital assistant. In other examples, the remote control device 310 may be a notebook, desktop computer or computer server, as is known in the art. The remote control device 310 can be located close to the patient. For example, as previously described, the remote control device 310 can be a portable device that is placed in a pocket, backpack, holster or belt used by the patient and configured to position the remote control device 310 as close to the pump assembly. 100 as possible. In other examples, the remote control device 310 may be a stationary electronic device placed, for example, in a patient's home or in the hospital room, and configured to communicate with pump set 100 via a data communication protocol. long-range, such as WiFi.
[0170] [0170] In some examples, the remote control device 310 comprises a controller 312, a communication interface 314 configured to communicate with the pump set 100 and with other devices or remote computer networks and, optionally, a field generator electromagnetic 316 configured to generate an electromagnetic field to cause the induction coil 210 to generate energy.
[0171] [0171] In some examples, the remote control device 310 further comprises a feedback module and / or user interface 318 operationally connected to a feedback device, such as a visual display 320. The feedback module and / or user interface 318 is configured to receive information generated by one or more sensors 230, 232 associated with the pump module 110, and to provide feedback to the user about the operating conditions of the pump set 100 and / or a physiological condition of the patient. For example, the feedback module and / or user interface 318 can be configured to make the visual display 320 display information about a volume and / or rate of flow of urine that passes through flow channel 122 or an amount of negative pressure being generated by the pump module 110. In other examples, the information displayed may also include information about the pump assembly 100, such as a remaining charge of battery 226 or the estimated time until battery 226 needs to be recharged. In some examples, information about a treatment protocol for a patient may also be displayed. For example, information about the amount of time negative pressure will continue to be delivered to the patient or showing a pattern of positive and negative pressures to be delivered to the patient can be displayed.
[0172] [0172] In some examples, communication interface 314 comprises a short-range data transceiver 322 configured to communicate with the communications interface of control module 112. For example, short-range data transceiver 322 may comprise a Bluetooth® transceiver, near-field communications transceiver (for example, RFID) or similar data transmission device. Since the remote control device 310 is configured to be positioned as close as possible to the pump assembly 100, the transmission range of the short-range data transceiver 322 need only be a few centimeters away. In some examples, the communications interface 314 further comprises a long-range data transceiver 324 for transmitting information collected by the pump set 100 and the remote control device 310 to a remote source such as a computer network 326, a database 328 or a web-based network portal or website 330. For example, information about the patient and / or the treatment provided by the pump set 100 can be transmitted from the remote control device 310 to the remote database 328 for inclusion in the patient's electronic medical record. Confirmation that treatment has been provided can also be passed on to medical professionals, such as a responsible physician. In some cases, the doctor can review confirmation and physiological information about the patient using, for example, the Web-based portal 330. Deployment
[0173] [0173] Pump set 100, battery 226 and / or induction coil 220 are configured to be inserted into the bladder, ureter and / or renal pelvis through the patient's urethra. In order to facilitate placement and implantation in this manner, the pump assembly 100 described herein is configured to fit within an implantation device, such as a catheter tube, and, once advanced from the tube, is configured to make automatic transition to implanted positions. In some configurations, the entire set, including the pump module, the control module and the induction coil, can be delivered to the ureter and bladder through the urethra using, for example, a 12 to 16 Fr catheter (outside diameter 4.0 to 5.3 mm). In other examples, parts of the pump set can be delivered through an abdominal incision or a transdermal nephrostomy or urostomy procedure.
[0174] [0174] As shown in FIGS. 13A and 13B, an exemplary implantation catheter 410 for use with pump assembly 100 comprises a flexible elongated tube 412 comprising an open distal end 414 configured to be inserted into the urinary tract through the urethra, a proximal end 416, which can be configured to remain outside the patient's body and a side wall 418, like a substantially continuous side wall formed from a flexible medical grade plastic material, extending between them. For example, elongated tube 412 can be formed from materials that include biocompatible polymers, polyvinyl chloride, polytetrafluoroethylene (PTFE), such as Teflon®, silicone or silicone coated latex. In one example, tube 412 is formed from thermoplastic polyurethane. At least a portion or all of catheter 410, such as tube 412, can be coated with a hydrophilic coating to facilitate insertion and / or removal and / or to increase comfort. In some instances, the coating is a hydrophobic and / or lubricant coating. For example, suitable coatings may comprise the ComfortCoat® hydrophilic coating that is available from Koninklijke DSM N.V. or hydrophilic coatings comprising polyelectrolytes, such as those disclosed in United States Patent No. 8,512,795, which is incorporated herein by reference.
[0175] [0175] In some examples, the proximal end 416 of tube 412 may comprise a hub (not shown) including a lumen port of a guide wire to assist a user in positioning catheter 410 through the urethra and into the bladder and / or ureter. Catheter 410 can be a standard implantation catheter formed from a flexible biocompatible material, such as, for example, silicone rubber. The elongated tube 412 can have any standard size for insertion into the urinary tract, such as a 12 Fr to 16 Fr tube. The length of the elongated tube 412 can vary from about 30 cm to about 120 cm, depending on the sex and age of the patient. patient.
[0176] [0176] As shown in FIGS. 13A and 13B, pump assembly 100, including pump module 110, control module 112 and induction coil 210, is configured to be positioned inside tube 412 in a contracted position. The pump assembly 100 is advanced through the tube 412 by a pressure rod 420, as shown in FIG. 13B. Once the open distal end 414 of catheter 410 is advanced through the urinary tract to a desired position within the bladder, ureter or kidney, a user can advance the impeller rod 420 through the elongated tube 412 to make the components of the assembly of the pump 100 leave the tube 412 through its open distal end 414. Once they leave the tube 412, the structures of the pump module 110 and the control module 112 can move from a contracted position to an implanted position. For example, barbs extending radially 140 (shown in FIG. 4) may extend radially outwardly from side wall 120 of pump module 110 and contact the inner wall of the ureter to maintain the position of pump module 110 inside the ureter. Similarly, once the induction coil 210 extends beyond the open distal end 414 of the elongated tube 412, it can unfold in the manner described above. In some examples, induction coil 210 can be deflected into its unwound state, at which point it can automatically unwind as soon as it is removed from elongated tube 412. In other examples, a user can cause induction coil 210 unwind manually by pressing a release button or trigger wire.
[0177] [0177] To implant pump set 100 into a patient's urinary tract, a medical professional can first advance a guidewire to a desired position in the bladder and / or ureter. In some cases, visualization devices, such as a cystoscope, can be used to view the bladder and ureter openings to assist in positioning the distal end of the guidewire. Delivery catheter 410 can be delivered via the guide wire. For example, a medical professional can insert the delivery catheter 410 over the guide wire and advance the distal end 414 of catheter 410 over the guide wire toward ureteral orifice 24, 26. Once the distal end 414 of catheter 410 is in place, the medical professional can start pushing the pump assembly 100 from the elongated tube 412 by advancing the pusher rod 420 through the elongated implantation tube 412. As it is expelled from the elongated tube 412, the open distal end 118 of the pump module 110 will be advanced through the ureteral orifice 24, 26 and at the distal end of the patient's ureter. Control module 112 and induction coil 220 can remain in the bladder.
[0178] [0178] In some examples, as discussed earlier, housings 114, 128 of pump module 110 and / or control module 112 may include retractable or permanently extended barbs 140, 144 for mounting modules 110, 112 on a surface of the ureter, renal pelvis, bladder or urethra. In some examples, since the pump assembly 100 comprising the pump module 110 and the control module 112 is in position in the patient's urinary tract, the user can trigger a release mechanism to cause the splinters 140, 144 extend towards the inner wall of the ureter, renal pelvis, bladder or urethra. In other examples, barbs 140, 144 may automatically extend as the elongated tube is being retracted. The retraction of the elongated tube 412 also causes the implantable induction coil 210 to unwind from a rolled-up configuration to a substantially flat configuration.
[0179] [0179] According to another example of the disclosure, a bladder pump assembly 500 for inducing negative pressure in the bladder is illustrated in FIG. 14. Negative pressure induced in the bladder also acts on the ureter and kidneys to draw urine from the kidneys. As discussed here, this negative pressure is believed to improve urine production, resulting in physiological benefits, such as reduced venous congestion and reduced risk of acute kidney injury.
[0180] [0180] As shown in FIG. 14, the bladder pump assembly, generally shown as 500, comprises a pump module 510. The pump module 510 may be substantially similar to the pump modules described above and may include, for example, impeller or piezoelectric configurations, such as shown in FIGS. 7 and 8. In some examples, the pump module 510 comprises an annular housing 512 sized for placement in the patient's bladder. For example, pump module 510 can be placed adjacent to the urethral opening or uretereal sphincter 20, so that sphincter 20 is sealed around an outer circumference 514 of the housing to prevent fluid from leaking from the bladder.
[0181] [0181] In some examples, the pump module 510 comprises orifices or fluid inlets 532 that extend through a side wall 534 of module 510 to pull fluid into a central channel 513 of module 510. In some examples, the diameters of each of the drain holes or ports 532 are about 0.5 mm to 2.0 mm or 0.75 mm to 1.0 mm. The distance between adjacent drain holes or ports 532 around the circumference of the side wall 534 can be from about 5 mm to about 30 mm or about 10 mm to 20 mm. Holes or doors 532 may comprise a circular opening, a square shaped opening, an elliptical opening and any combination thereof. In some instances, the ports or ports 532 may be covered by a screen or filter to prevent solid materials from being attracted to the pump module 510.
[0182] [0182] The set 500 further comprises a bladder wall support 516 extending from the pump module 510. The bladder wall support 516 is configured to prevent an upper portion 15a of the bladder wall from collapsing when pressure negative pressure is applied to the bladder 12, ureter 8, 10 and kidneys 4, 6 by the pump module 510. In particular, the bladder wall support 516 maintains at least the upper portion 15a of the bladder 12 in a non-collapsed state in which the ureteral holes 24, 26 are not occluded by the collapsed bladder wall 15. Exemplary bladder wall supports, which can be used in a negative pressure therapy system to provide negative pressure to parts of the urinary tract, such as the bladder, the ureters and the kidneys, are described in International Publication No. WO 2017/015345, entitled “Catheter device and method to induce negative pressure in the patient's bladder”, the content of which is incorporated by reference here in its entirety.
[0183] [0183] In some examples, the bladder wall support 516 comprises an inflatable balloon 518 configured to expand from a collapsed state to an inflated state. The balloon 518 is configured to isolate the region of the triangle 22 of the bladder 12 from the upper wall of the bladder 15a, preventing,
[0184] [0184] As shown in FIG. 14, in some instances, balloon 518 has a substantially flattened or elongated cross section with a maximum inflated width L1 of, for example, about 15 cm or less or about 10 cm or less, which is greater than its maximum inflated height L2 of, for example, about 5 cm or less or 2.5 cm or less. The L1 width generally corresponds to the width of a patient's bladder. In some instances, a lower or proximal surface 520 of balloon 518 is a concave surface displaced from the proximal surface of the bladder by about 1 cm to about 3 cm, to allow free flow of urine from the ureter orifice 24 .
[0185] [0185] The pump assembly 500 further comprises a drain pipe or tube 522 comprising an elongated tubular member 524. As previously described, a tubular member for insertion into the urinary system, such as tubular member 524, can be formed from any suitable flexible material, including biocompatible polymers, polyvinyl chloride, polytetrafluoroethylene (PTFE), such as Teflon®, silicone or silicone coated latex. In some examples, at least a portion or the entire tubular member may be coated with a hydrophilic coating to facilitate insertion and / or removal and / or to increase comfort. In some instances, the coating is a hydrophobic and / or lubricant coating. For example, a suitable coating may comprise the ComfortCoat® hydrophilic coating.
[0186] [0186] In some examples, the elongated tubular member 524 extends from a proximal end 511 of the pump module 510, through the urethra 18 and extends to the outside of the patient's body. The drainage catheter 522 can be connected to a fluid collection container, such as a urine collection bag (not shown). Drainage catheter 522 can be a one or more lumen catheter comprising one or more drainage lumens 526 in fluid communication with channel 513 of pump module 510. In some instances, drainage catheter 522 further comprises an inflation lumen 528 in fluid communication with the inner part 530 of the inflatable balloon 518. As shown in FIG. 14, in some instances, the inflation lumen 528 extends through the pump module 510 and into the balloon 530
[0187] [0187] In some examples, inflation lumen 528 extends through drain lumen 526, as shown in FIG. 14. For example, the inflation lumen 528 can extend through the drain lumen 526, so that a longitudinal central axis X1 of the drain lumen 526 is substantially coextensive with a longitudinal central axis of the inflation lumen 528. However, many different provisions of drainage lumen 526 and inflation lumen 528 can be used within the scope of this disclosure. For example, a separate drainage lumen 526 and an inflation lumen 528 can extend through drainage catheter 522 in a side-by-side configuration. Other configurations of drainage lumen 526 and inflation lumen 528 will also be evident to those skilled in the art.
[0188] [0188] During use, bladder pump assembly 500 comprising pump module 510, bladder wall support 516 and elongated tubular member 524 is advanced through urethra 18 to bladder 12. Balloon 518 of the wall support the bladder 516 is then expanded into the bladder 12 as shown in FIG. 14. Once the elongated member 524 and the pump module 510 are positioned, the urethral sphincter 20 can be sealed or partially sealed around the outer circumference 514 of the pump module 510. Once the balloon 518 and the pump 510 are positioned inside the bladder 12, a user can trigger a pump element from the pump module 510 to draw urine from the bladder 12 to the pump module 510 through the fluid inlet ports 532. The negative pressure generated by the pump module Pump 510 also acts on more distal portions of the urinary tract. For example, ureters and kidneys can be exposed to negative pressure to increase renal perfusion in the manner described here. When pump module 510 is triggered, fluid is drawn through channel 513 of pump module 510 due to movement of the pump element and expelled from the pump module
510 to the drainage lumen 526 of the drainage catheter 522. The collected fluid is drained from the body through the drainage catheter 522, where it is collected in a fluid collection container, such as a bag located outside the patient's body.
The collected urine can be analyzed to monitor the patient's physiological condition and to confirm that the 510 pump assembly is operating and providing negative pressure as expected.
The pump module 510 may further comprise sensors 230, 232, as discussed above to monitor pump performance and / or physiological conditions, as desired.
The previous examples and embodiments of the invention have been described with reference to several examples.
Modifications and changes are possible after reading and understanding the previous examples.
Therefore, the previous examples should not be construed as limiting disclosure.

权利要求:
Claims (54)
[1]
1. Pump set, characterized by the fact that it comprises: (a) a pump module, in which at least a part of the pump module is configured to be positioned within at least an inner portion of a ureter, an inner portion of a renal pelvis, inner portion of a bladder or inner portion of a patient's urethra to supply negative pressure to at least one of the patient's ureters or kidneys, the pump module comprising: a housing comprising an open proximal end, a distal end open, and a side wall that extends between the definition of a flow channel for the conduction of fluid through at least an internal portion of the patient's ureter, the internal portion of the patient's renal pelvis, the internal portion of the patient's bladder or the internal portion of the patient's urethra, in which at least a portion of the housing is configured to be positioned within at least one internal part of the ureter, an internal portion of the renal pelvis, a po internal bladder removal or an internal portion of a patient's urethra; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the flow rate of the fluid passing through the channel, the control module comprising a configured housing to be positioned within at least a second internal portion of the patient's ureter, a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra.
[2]
2. Pump assembly according to claim 1, characterized in that the maximum external diameter of the pump module housing is less than the maximum external diameter of the control module housing.
[3]
3. Pump assembly according to claim 2, characterized in that the maximum external diameter of the pump module housing is from about 0.5 mm to about 5.0 mm.
[4]
4. Pump set according to any one of claims 1 to 3, characterized in that the maximum outer diameter of the control module housing is greater than the inner diameter of the patient's ureter, so that the control module do not pass from the patient's bladder to the ureter.
[5]
Pump assembly according to any one of claims 1 to 4, characterized in that the housing of the pump module comprises one or more retaining members extending from the side wall to freely secure a portion from the pump module housing to at least an inner part of the ureter, an inner portion of the renal pelvis or an inner portion of a patient's bladder.
[6]
6. Pump set according to claim 5, characterized in that the retaining members are retractable to allow removal of the pump module from the ureter, renal pelvis or bladder.
[7]
7. Pump assembly according to claim 5,
characterized by the fact that the retaining members have a length when extended by less than about 3 mm.
[8]
Pump assembly according to any of claims 1 to 7, characterized in that the housing of the control module comprises one or more retaining members extending from it to freely secure the housing of the module control to an internal portion of a patient's bladder.
[9]
Pump assembly according to any one of claims 1 to 8, characterized in that at least a portion of the housing comprises a drainage channel comprising a distal portion configured to be positioned within at least one between the inner portion distal of the ureter and / or the inner portion of a patient's renal pelvis.
[10]
10. Pump assembly according to claim 9, characterized in that the drainage channel is formed integrally with the housing or as a separate tube or conduit in fluid connection with the open distal end of the housing.
[11]
Pump assembly according to claim 9 or 10, characterized in that the distal portion of the drain channel comprises a coil.
[12]
Pump assembly according to claims 9, 10 or 11, characterized in that the coil comprises one or more perforations in a side wall of the coil.
[13]
Pump assembly according to claims 9, 10, 11 or 12, characterized in that the coil comprises one or more perforations on one side facing into a side wall of the coil.
[14]
Pump assembly according to any one of claims 1 to 13, characterized in that the pump module housing is integrally formed or connected to the control module housing.
[15]
Pump assembly according to any one of claims 1 to 14, characterized in that the control module housing is a generally cylindrical housing comprising an open distal end connected to the open proximal end of the pump module housing, an open proximal end and a flow channel in fluid communication with the flow channel of the pump module housing and extending between the proximal end and the distal end of the control module housing.
[16]
16. Pump assembly according to any one of claims 1 to 15, characterized in that the control module housing is separate from the pump module housing and in which the electronic circuit of the control module is functionally connected to the pump module via a wired or wireless connection.
[17]
Pump assembly according to any one of claims 1 to 16, characterized in that the pump element comprises an impeller positioned within the channel of the pump module compartment which rotates to draw fluid through the channel.
[18]
18. Pump assembly according to any one of claims 1 to 17, characterized in that the pump element comprises a piezoelectric diaphragm positioned within the channel that can be configured to extend and retract alternately to an internal surface of the side wall to pull fluid through the channel.
[19]
19. Pump assembly according to claim 18, characterized in that the pump module further comprises a distal valve positioned on a portion of the channel distal to the pump element and a proximal valve positioned on a portion of the channel proximal to the element the pump.
[20]
20. Pump assembly according to claim 19, characterized in that the distal valve and the proximal valve comprise a unidirectional check valve configured to produce unidirectional flow of fluid through the channel from the distal end to the proximal end thereof.
[21]
21. Pump assembly according to any one of claims 1 to 20, characterized in that the pump module is configured to provide negative pressure between about 0 mmHg and about 150 mmHg.
[22]
22. Pump assembly according to any one of claims 1 to 21, characterized in that the pump module is configured to produce a negative pressure in the ureter sufficient to establish a pressure gradient through the filtration anatomy of a kidney of a patient to facilitate the flow of urine towards the ureter.
[23]
23. Pump assembly according to any one of claims 1 to 22, characterized in that it also comprises a battery positioned in at least one of the control module compartments or in the pump module compartment to supply power to at least one of the pump modules or elements.
[24]
24. Pump assembly according to claim 23,
characterized by the fact that the battery is rechargeable.
[25]
25. Pump assembly according to any one of claims 1 to 24, characterized in that the control module comprises a wireless transceiver configured to receive operating instructions from a remote device and provide information about the negative pressure treatment of the control module for the remote device.
[26]
26. Pump set according to any one of claims 1 to 25, characterized by the fact that it also comprises an induction coil electronically coupled to at least one pump module or control module to supply energy to it, the coil being of induction configured to generate energy when exposed to an electromagnetic field generated by a remote device positioned outside or inside the patient's body.
[27]
27. Pump assembly according to claim 26, characterized in that the induction coil comprises a conductor wire at least partially arranged on a flexible substrate.
[28]
28. Pump assembly according to claim 27, characterized in that the flexible substrate can pass from a rolled configuration in which the flexible substrate is rolled around its central axis to a suitable size, for delivery via a catheter, to an implanted configuration in which the flexible substrate is at least partially unwound from the rolled configuration.
[29]
29. Pump set according to claims 26, 27 or 28, characterized by the fact that it also comprises a battery electronically coupled to the induction coil, the battery being configured to be recharged by the energy produced by the induction coil.
[30]
30. Pump set for negative pressure induction in a patient's bladder, characterized in that the set comprises: a pump module, in which at least a portion of the pump module is configured to be positioned in a portion of a bladder of a patient, the pump module comprising a housing comprising an open proximal end, an open distal end and a side wall extending between them, the housing defining a flow channel for conducting fluid through an interior portion of the patient's bladder and a pump element at least partially positioned within the channel that is configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; a bladder wall support to maintain at least a portion of the bladder wall in an unbroken state, in which the holes in the ureter are not occluded by the bladder wall; and a drainage catheter extending from the proximal end of the pump module through the urethra and the patient's body, the drainage catheter comprising a drainage lumen in fluid communication with the pump module channel to direct the expelled fluid body from the pump module.
[31]
31. The pump assembly according to claim 30, characterized in that the bladder wall support comprises an inflatable balloon that isolates the trigone, comprising an upper surface portion to support an upper wall of the patient's bladder and a portion concave bottom surface.
[32]
32. Pump set according to claim 30 or 31, characterized in that the trine isolation balloon has a maximum inflated height of about 5 cm and a maximum inflated width of about 15 cm.
[33]
33. Pump assembly according to claims 30, 31 or 32, characterized in that the drainage catheter further comprises an inflation lumen in fluid communication with the internal part of the trine isolation balloon to supply fluid to the internal part of the trine isolation balloon in order to inflate the balloon.
[34]
34. Pump assembly according to claim 33, characterized in that the inflation lumen extends through the drainage channel, so that a longitudinal central axis of the drainage channel is substantially coextensive with a longitudinal central axis of the lumen inflation.
[35]
35. Pump assembly according to claims 30, 31, 32, 33 or 34, characterized in that the pump module compartment further comprises a plurality of drainage openings extending through it to extract fluid from the bladder to the flow channel.
[36]
36. Pump assembly according to claims 30, 31, 32, 33, 34 or 35, characterized in that the pump module further comprises an annular filter that extends over at least a portion of the housing sidewall and it covers one or more of the plurality of drainage openings to filter the fluid as the fluid is attracted to the flow channel.
[37]
37. Pump set, characterized by the fact that it comprises: (a) a pump module, in which at least a portion of the pump module is configured to be positioned within at least one of an internal portion of a ureter, a portion inner portion of a renal pelvis, an inner portion of a bladder or an inner portion of a patient's urethra to supply negative pressure to at least one of the patient's ureters or kidneys, the pump module comprising: a housing comprising an open proximal end , an open distal end, and a side wall that extends between the definition of a flow channel for conducting fluid through at least part of the patient's inner ureter, an inner portion of the patient's bladder, a portion of the patient's bladder or an internal portion of the patient's urethra, wherein at least a portion of the housing comprises a drainage channel comprising a distal portion configured to be positioned within ro of at least one distal inner portion of the ureter or inner portion of a patient's renal pelvis; a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the rate of fluid flow passing through the channel, the control module comprising a configured housing to be positioned inside a second internal portion of the patient’s ureter,
a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra, in which the drainage channel is formed integrally with the housing or as a separate tube or conduit in fluid connection with the open distal end of the housing.
[38]
38. System to provide negative pressure therapy to a patient's ureter or kidney, the system characterized by the fact that it comprises: a pump assembly, comprising: (a) a pump module, in which at least a portion of the pump module it is configured to be positioned inside at least one inner part of a ureter, an inner part of a renal pelvis, an inner part of a bladder or an inner part of a patient's urethra to supply negative pressure to at least one of the ureters or kidney, the pump module comprising: a housing comprising an open proximal end, an open distal end and a side wall extending between them defining a flow channel for conducting fluid through at least an internal portion of the ureter of the patient, an internal portion of the patient's renal pelvis, an internal portion of the patient's bladder or an internal portion of the patient's urethra, in which at least a portion of the housing is configured to be positioned inside at least an inner part of the ureter, an inner part of the renal pelvis, an inner part of the bladder or an inner part of a patient's urethra; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the rate of fluid flow passing through the channel, the control module comprising a configured housing to be positioned in at least a second internal portion of the patient's ureter, a second internal portion of the patient's renal pelvis, a second internal portion of the patient's bladder or a second internal portion of the patient's urethra; a power supply to supply power to the pump set; and a remote control device in wired or wireless communication with the control module, the remote control device being configured to instruct the control module to operate the pump assembly and to receive information from the control module about at least one the pump modules or the patient.
[39]
39. System according to claim 38, characterized in that the maximum external diameter of the pump module housing is less than the maximum external diameter of the control module.
[40]
40. System according to claims 38 or 39, characterized in that the control module is sized for insertion into the patient's bladder.
[41]
41. System according to claims 38, 39 or 40, characterized in that the power supply is a battery.
[42]
42. System according to claims 38, 39, 40 or
41, characterized by the fact that the power supply is an induction coil.
[43]
43. The system according to claim 38, characterized in that the power supply also comprises a battery electronically coupled to the induction coil, the battery being configured to be recharged by the energy produced by the induction coil.
[44]
44. System according to claim 38, characterized in that the power source also comprises a battery electronically coupled to the induction coil, the battery being configured to be recharged by the energy produced by the induction coil.
[45]
45. System according to claim 44, characterized in that the information received from the control device comprises at least indications that the battery is being recharged by the induction coil, an indication that the battery is fully charged or an indication remaining battery charge.
[46]
46. System according to claims 38, 39, 40, 41, 42, 43, 44 or 45, characterized by the fact that it also comprises a remote database comprising electronic patient health records and in which the control device The remote is configured to wirelessly transmit patient information to the remote database.
[47]
47. System according to claims 38, 39, 40, 41, 42, 43, 44, 45 or 46, characterized by the fact that it also comprises sensors in fluid communication with the flow channel of the pump module housing, being sensors configured to measure a pump operating parameter or a patient's physiological condition based on detected information about fluid passing through the flow channel.
[48]
48. System according to claims 38, 39, 40, 41, 42, 43, 44, 45, 46 or 47, characterized in that the remote control device further comprises a screen and in which the remote control device it is configured to display information received from the control module about at least one between the pump module or the patient on the display.
[49]
49. Method for treating a patient, providing negative pressure therapy to a portion of the patient's urinary tract, characterized by the fact that the method comprises: positioning a pump assembly comprising: (a) a pump module, in which at least one portion of the pump module is configured to be positioned within at least one inner part of a ureter, an inner part of a renal pelvis, an inner part of a bladder or an inner part of a patient's urethra to provide negative pressure to at least one ureter or kidney of the patient, the pump module comprising: a housing comprising an open proximal end, an open distal end and a side wall that extends defining a flow channel for the conduction of fluid through at least a portion internal portion of the patient's ureter, an internal portion of the patient's renal pelvis, an internal portion of the patient's bladder or an internal portion of the patient's urethra, in which at least a portion of the the housing is configured to be positioned within at least an inner portion of the ureter, an inner portion of the renal pelvis, an inner portion of the bladder or an inner portion of a patient's urethra; and a pump element at least partially positioned within the channel configured to draw fluid through the channel between the open distal end and the open proximal end of the housing; and (b) a control module coupled to the pump module, the control module being configured to direct the movement of the pump element to control the flow rate of the fluid passing through the channel, the control module comprising a configured housing to be positioned within at least a second inner portion of the patient's ureter, a second inner portion of the patient's renal pelvis, a second inner portion of the patient's bladder or a second inner portion of the patient's urethra; and activating the pump module, causing the pump module to draw fluid through its channel to supply negative pressure to a portion of the patient's urinary tract.
[50]
50. Method, according to claim 49, characterized in that the control module housing is sized for insertion into the patient's bladder and in which the maximum external diameter of the pump module is less than the maximum external diameter of the control.
[51]
51. Method according to claims 49 or 50, characterized in that the set is implanted within a portion of the patient's bladder and / or ureter using a catheter.
[52]
52. Method according to claims 49, 50 or 51, characterized in that the positioning of the pump assembly also comprises implanting splinters against an internal wall of the bladder and / or ureter to maintain the positioning of the pump assembly within bladder and / or ureter.
[53]
53. Method according to claims 49, 50, 51 or 52, characterized in that the negative pressure is provided in a range between 0 and about 150 mmHg.
[54]
54. Method according to claims 49, 50, 51, 52 or 53, characterized in that the activation of the pump module also comprises the periodic inversion of the pump direction for a period of time to provide intermittent positive pressure to the tract patient's urinary tract.

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WO2019038730A1|2019-02-28|

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法律状态:
2021-11-23| B350| Update of information on the portal [chapter 15.35 patent gazette]|

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

优先权:

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申请号 | 申请日 | 专利标题

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US201762550259P| true| 2017-08-25|2017-08-25|

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US62/550,259|2017-08-25|

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PCT/IB2018/056444|WO2019038730A1|2017-08-25|2018-08-24|Indwelling pump for facilitating removal of urine from the urinary tract|

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