Systems and methods for percutaneous drainage

Abstract

A system for percutaneous drainage of a drainage site includes a catheter, a drainage tube, a first pump, a flushing tube, a second pump, and a controller. The catheter includes a drainage lumen defined by a first portion of a catheter wall and a septum, and a flushing lumen defined by a second portion of the catheter wall and the septum. The flushing lumen is separated from the drainage lumen by the septum. At least one septum aperture is provided in the septum such that the drainage lumen and the flushing lumen are in communication through the at least one septum aperture. At least one wall aperture is provided in the catheter wall such that the drainage lumen is in communication with the drainage site when a distal end portion of the catheter is placed within the drainage site.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 137,092, filed January 13, 2021, the contents of which are incorporated herein by reference in their entirety and priority is claimed therein. Technical Field

[0003] The disclosed topics relate to systems and methods for percutaneous drainage, such as for the removal of abnormal, potentially infected fluid aggregates from the body. Background Technology

[0004] Pathological fluid can accumulate in the body due to infection / inflammation (i.e., abscess), visceral obstruction / perforation (i.e., urinary tract or bile duct blockage), and / or bleeding (i.e., hematoma). The fluid can be drained using image-guided percutaneous drainage systems. For example, using computed tomography (CT), ultrasound (US), and / or fluorescence (XR) guidance, medical practitioners (such as interventional radiologists) can noninvasively visualize abnormal fluid accumulations and subsequently use minimally invasive techniques to insert a drainage catheter through the skin into the accumulation.

[0005] Drainage catheters can be hollow plastic tubes of variable length and lumen diameter; the most common type is called a "tailed" catheter, referring to the annular shape formed at its distal end. Drainage catheters function by having one or more side holes at their distal end through which abnormal fluid can enter the lumen of the catheter and be collected in a bag attached to its proximal end. Drainage can be performed by gravity or with intermittently applied ball suction. The average indwelling time of a drainage catheter can be approximately 28 days, and device failure due to lumen blockage / occlusion caused by viscous fluids and / or particulate matter can occur in 25-30% of cases, regardless of the tube diameter. Incorrect drainage can lead to recurrence of the patient's disease and may require repeated invasive procedures, which may include additional risks and costs to prevent sepsis-related death. Studies have shown that up to 85% of drainage catheters may require at least one replacement before removal, and 50% may require enlargement, although larger diameters have not been shown to offer a significant advantage in terms of lumen patency or required indwelling time.

[0006] To help maintain lumen patency, healthcare providers, patients, and / or caregivers can be instructed to manually inject a predetermined volume of sterile saline into the catheter at a predetermined frequency. This increases lumen lubrication, removes adhering debris from the catheter walls and side holes, and reduces the viscosity of the drainage fluid. However, this intervention is not always effective, and non-compliance is a common problem. Forgetting to flush the catheter, injecting too little or too much fluid, and using non-sterile tap water instead of sterile saline are common causes of catheter blockage, delayed healing, and other complications such as catheter-related superficial or deep tissue infections.

[0007] In addition, patients often report negative psychosocial effects from prolonged use of one or more drainage catheters. The tubes and waste collection bags can be bulky, uncomfortable, unsightly, and cause feelings of shame in society.

[0008] Therefore, there is a need to improve the systems and methods used for percutaneous drainage. Summary of the Invention

[0009] The purposes and advantages of the disclosed subject matter will be set forth in and apparent from the following description, and will also become apparent from practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and obtained by means of the methods and systems particularly pointed out in the written description and claims, and by means of the accompanying drawings.

[0010] To achieve these and other advantages, and in accordance with the purposes of the disclosed subject matter, as implemented and extensively described, the disclosed subject matter relates to systems and methods for percutaneous drainage. For example, a system for percutaneous drainage of a drainage site includes a catheter, a drainage tube, a first pump, a flushing tube, a second pump, and a controller. The catheter includes: a catheter wall extending from a proximal portion of the catheter to a distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; a diaphragm disposed within the catheter wall and extending from the proximal portion of the catheter to the distal portion of the catheter; a drainage cavity defined by the first portion of the catheter wall and the diaphragm, extending from the proximal portion of the catheter to the distal portion of the catheter; and a flushing cavity defined by a second portion of the catheter wall and the diaphragm, extending from the proximal portion of the catheter to the distal portion of the catheter, wherein the flushing cavity is separated from the drainage cavity by the diaphragm. The drainage tube has a first end coupled to the drainage cavity at the proximal portion of the catheter and a second end coupled to a waste collection container. A first pump is coupled to the drainage tube between a first end and a second end of the drainage tube. A flushing tube includes a first end coupled to a flushing chamber at a proximal portion of the catheter and a second end coupled to a flushing material container having flushing material disposed therein. A second pump is coupled to the flushing tube between the first end and the second end of the flushing tube. A controller is coupled to the first and second pumps for controlling the first and second pumps. A diaphragm has at least one diaphragm orifice disposed therein near the distal portion of the catheter, such that the drainage chamber and the flushing chamber communicate through the at least one diaphragm orifice. The catheter wall has at least one wall orifice disposed therein near the distal portion of the catheter, such that when the distal portion of the catheter is placed within the drainage site, the drainage chamber communicates with the drainage site.

[0011] The volume of the drainage cavity can be equal to the volume of the flushing cavity. The volume of the drainage cavity can be greater than the volume of the flushing cavity. At least one diaphragm orifice can include multiple diaphragm orifices. At least one diaphragm orifice can include a distal orifice having a first diameter and a proximal orifice having a second diameter, which is different from the first diameter. The second diameter can be smaller than the first diameter. At least one diaphragm orifice and at least one wall orifice can be offset.

[0012] The system may include a pressure sensor or flow monitoring sensor coupled to a drainage tube and a controller. The system may include a housing in which a first pump, a second pump, and a controller are disposed. The system may include an injection port coupled to a flushing tube. The system may include a syringe coupled to the injection port via a third tube, and / or the system may include a third pump coupled to the injection port via a third tube.

[0013] According to the disclosed subject matter, a catheter for percutaneous drainage of a drainage site is provided. The catheter may include: a catheter wall extending from a proximal portion of the catheter to a distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; a septum disposed within the catheter wall and extending from the proximal portion of the catheter to the distal portion of the catheter; a drainage lumen defined by a first portion of the catheter wall and the septum, extending from the proximal portion of the catheter to the distal portion of the catheter; and an irrigation lumen defined by a second portion of the catheter wall and the septum, extending from the proximal portion of the catheter to the distal portion of the catheter, wherein the irrigation lumen and the drainage lumen are separated by the septum. The septum may have at least one septum orifice disposed therein near the distal portion of the catheter, such that the drainage lumen and the irrigation lumen communicate through the at least one septum orifice. The catheter wall has at least one wall orifice disposed therein near the distal portion of the catheter, such that when the distal portion is placed within the drainage site, the drainage lumen communicates with the drainage site.

[0014] Based on the disclosed subject matter, a method for percutaneous drainage of a drainage site is provided. The method may include inserting a catheter into a drainage site, the catheter comprising: a catheter wall extending from a proximal portion of the catheter to a distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; a diaphragm disposed within the catheter wall and extending from the proximal portion of the catheter to the distal portion of the catheter; a drainage cavity defined by a first portion of the catheter wall and the diaphragm, extending from the proximal portion of the catheter to the distal portion of the catheter; and an irrigation cavity defined by a second portion of the catheter wall and the diaphragm, extending from the proximal portion of the catheter to the distal portion of the catheter, wherein the irrigation cavity and the drainage cavity are separated by the diaphragm; wherein the diaphragm has at least one diaphragm orifice disposed therein near the distal portion of the catheter, such that the drainage cavity and the irrigation cavity communicate through the at least one diaphragm orifice; and wherein the catheter wall has at least one wall orifice disposed therein near the distal portion of the catheter, such that the drainage cavity communicates with the drainage site when the distal portion is placed within the drainage site. The method may further include extracting fluid from the drainage site through the drainage cavity; identifying blockages in the drainage cavity; flushing with flushing fluid through the flushing cavity and into the drainage cavity through at least one diaphragm hole to eliminate the blockage; and restoring fluid extraction from the drainage site through the drainage cavity.

[0015] The method may include pausing fluid extraction from the drainage site through the drainage chamber. Pausing may include reversing the flow direction of the fluid in the drainage chamber. The method may include monitoring the rate at which fluid is extracted from the drainage site. The method may include resuming fluid extraction from the drainage site through the drainage chamber. The method may include monitoring the rate of change of the rate at which fluid is extracted from the drainage site. Identifying blockages in the drainage tube may be based at least in part on one or more of the rate at which fluid is extracted from the drainage site and the rate of change of the rate at which fluid is extracted from the drainage site. The method may include monitoring the pressure in the waste chamber. The method may include monitoring the rate of change of the pressure in the waste chamber. Identifying blockages in the drainage chamber may be based at least in part on one or more of the pressure in the waste chamber and the rate of change of the pressure in the waste chamber.

[0016] According to the disclosed subject matter, a system for percutaneous drainage of a drainage site may include a catheter, a drainage tube, a first pump, a flushing tube, a second pump, and a controller. The catheter includes: a catheter wall extending from a proximal portion of the catheter to a distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; a diaphragm disposed within the catheter wall and extending from the proximal portion of the catheter to the distal portion of the catheter; a drainage cavity defined by the first portion of the catheter wall and the diaphragm, extending from the proximal portion of the catheter to the distal portion of the catheter; and a flushing cavity defined by a second portion of the catheter wall and the diaphragm, extending from the proximal portion of the catheter to the distal portion of the catheter, wherein the flushing cavity is separated from the drainage cavity by the diaphragm. The drainage tube has a first end coupled to the drainage cavity at the proximal portion of the catheter and a second end coupled to a waste collection container. The first pump is coupled to the drainage tube between the first end and the second end of the drainage tube. The flushing tube includes a first end coupled to a flushing chamber at the proximal portion of the catheter and a second end coupled to a flushing material container having flushing material disposed therein. A second pump is coupled to the flushing tube between the first and second ends. A controller is coupled to the first and second pumps for controlling the first and second pumps. A first portion of the catheter wall has at least one first wall hole disposed therein near the distal portion of the catheter, such that the drainage chamber communicates with the drainage site when the distal portion of the catheter is placed within the drainage site. A second portion of the catheter wall has at least one second wall hole disposed therein near the distal portion of the catheter, such that the flushing chamber communicates with the drainage site when the distal portion of the catheter is placed within the drainage site. Attached Figure Description

[0017] The patent or application document contains at least one color drawing. Upon request and payment of the necessary fees, the patent office will provide a copy of the color drawing of the patent or patent application publication.

[0018] Figure 1AThis is a schematic diagram of an exemplary system for percutaneous drainage based on the disclosed subject matter.

[0019] Figure 1B This is a schematic diagram of an exemplary system for percutaneous drainage based on the disclosed subject matter.

[0020] Figure 2 It is based on the disclosed subject matter used with Figure 1A A cross-sectional view of an exemplary conduit used in the system.

[0021] Figures 3A to 3C Provides options for use with the disclosed topic Figure 1A A cross-sectional view of an exemplary conduit used in the system.

[0022] Figure 4 It is based on the disclosed subject matter used with Figure 1A A perspective view of an exemplary housing used in the system.

[0023] Figure 5A and Figure 5B These are, respectively, an exemplary base and cover according to the disclosed subject matter, and a cover for use with... Figure 1A A three-dimensional diagram of certain components used in the system.

[0024] Figure 6 This refers to an exemplary housing based on the disclosed subject matter and for use with... Figure 1A A top sectional view of certain components used in the system.

[0025] Figure 7 It is based on the disclosed subject matter used with Figure 1A A block diagram of some components used in the system.

[0026] Figure 8 Provides options for use with the disclosed topic Figure 1A Multiple views of wearable components used in a system.

[0027] Figures 9A to 9C Provided for use with Figure 1A The system uses a graphical user interface view.

[0028] Figure 10 This is a schematic diagram of a portion of an exemplary system for percutaneous drainage, comprising multiple drainage catheters, according to the disclosed subject matter.

[0029] Figure 11 A control unit coupled to one or more modular pumps is shown, according to the disclosed subject matter.

[0030] Figure 12 The image shows the results of aspiration for 20 minutes using three different aspiration conditions based on the disclosed topic through a drainage catheter.

[0031] Figure 13 This is a schematic diagram of an exemplary conduit for computational fluid dynamics analysis based on the disclosed subject matter.

[0032] Figure 14 Exemplary results of computational fluid dynamics analysis of a duct based on the disclosed subject are shown.

[0033] Figure 15 Exemplary results of computational fluid dynamics analysis of ducts employing different flushing strategies according to the disclosed subject are shown.

[0034] Figure 16 Exemplary results of computational fluid dynamics analysis of a conduit with variable diaphragm orifice position according to the disclosed subject matter are shown.

[0035] Figure 17 Exemplary results of computational fluid dynamics analysis of a conduit with a variable diaphragm orifice diameter according to the disclosed subject matter are shown.

[0036] Figure 18 Exemplary results of computational fluid dynamics analysis of a catheter with a variable lumen volume ratio based on the disclosed subject matter are shown.

[0037] Figure 19 Exemplary results of computational fluid dynamics analysis of conduits with or without outward flushing holes, according to the disclosed subject matter, are shown.

[0038] Figure 20 Exemplary results of computational fluid dynamics analysis of catheters with or without distal orifices, according to the disclosed subject matter, are shown.

[0039] Figure 21 This is a flowchart of a method for percutaneous drainage of a drainage site.

[0040] Figure 22 This is a schematic diagram of an exemplary system for enteral feeding based on the disclosed subject matter. Detailed Implementation

[0041] Various exemplary embodiments of the disclosed subject matter will now be described in detail, and exemplary embodiments thereof are illustrated in the accompanying drawings. The singular forms used in the specification and appended claims, such as “a,” “an,” “the,” and singular nouns, are intended to include plural forms as well, unless the context clearly indicates otherwise.

[0042] Generally, and as described in more detail below, the disclosed subject matter includes systems and methods for percutaneous drainage. For example, a system for percutaneous drainage of a drainage site includes a catheter, a drainage tube, a first pump, a flushing tube, a second pump, and a controller. The catheter includes: a catheter wall extending from a proximal portion of the catheter to a distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; a diaphragm disposed within the catheter wall and extending from the proximal portion of the catheter to the distal portion of the catheter; a drainage cavity defined by the first portion of the catheter wall and the diaphragm, extending from the proximal portion of the catheter to the distal portion of the catheter; and a flushing cavity defined by the second portion of the catheter wall and the diaphragm, extending from the proximal portion of the catheter to the distal portion of the catheter, wherein the flushing cavity is separated from the drainage cavity by the diaphragm. The drainage tube has a first end coupled to the drainage cavity at the proximal portion of the catheter and a second end coupled to a waste collection container. The first pump is coupled to the drainage tube between the first end and the second end of the drainage tube. The flushing tube includes a first end coupled to a flushing chamber at the proximal portion of the catheter and a second end coupled to a flushing material container having flushing material disposed therein. A second pump is coupled to the flushing tube between the first and second ends. A controller is coupled to the first and second pumps for controlling the first and second pumps. A diaphragm has at least one diaphragm orifice disposed therein near the distal portion of the catheter, such that the drainage chamber and the flushing chamber communicate through the at least one diaphragm orifice. The catheter wall has at least one wall orifice disposed therein near the distal portion of the catheter, such that when the distal portion of the catheter is placed within the drainage site, the drainage chamber communicates with the drainage site.

[0043] Although the systems and methods described herein pertain to specific percutaneous drainage procedures, such as abscess drainage, these systems and methods can be used for a wide range of clinical applications common in interventional radiology and / or surgery. For example, the systems and methods described herein can be used for percutaneous pleurostomy (i.e., drainage of pleural fluids (liquid and / or gas) and / or pleurodesis); percutaneous pericardiostomy (i.e., pericardial drainage); percutaneous nephrostomy, ureterostomy, and / or cystostomy (i.e., drainage and / or irrigation of the urinary tract); percutaneous cholecystostomy and biliary tract (internal-external, external) drainage; percutaneous chemical ablation and / or sclerotherapy of cystic lesions, recurrent effusions (such as... Lymphocytic cysts and other lymphatic system diseases) and / or hollow viscera (such as the gallbladder in patients deemed unsuitable for cholecystectomy); percutaneous esophagostomy, gastrostomy, gastrojejunostomy, jejunostomy and / or cecumostomy (i.e., the digestive tract); percutaneous ventriculostomy and sheath drainage for hydrocephalus / cerebrospinal fluid hypertension; and percutaneous thrombolysis / thrombectomy / embolectomy for thromboembolic diseases of the arterial and / or venous vascular systems.

[0044] As described in more detail below, the systems and methods described herein can use an electric pump system to rapidly drain unwanted fluids from the body at a faster rate compared to standard drainage catheters that typically rely on gravity or manual aspiration. These systems and methods can detect changes in catheter pressure dynamics and fluid volume transfer via programmable sensors that indicate various system states, such as impending luminal occlusion, satisfactory drainage completion, and / or complications such as bleeding, pneumothorax, or fistula formation. These systems and methods can prevent and / or mitigate catheter obstruction through a self-flushing dual-lumen design using sterile saline and / or auxiliary chemical / biological agents. The systems and methods described herein may include programmable aspiration / flushing configurations tailored to the composition (e.g., volume, viscosity) of the fluid aggregate and can be remotely monitored and controlled via wireless technology. This allows healthcare providers and / or patients to adjust pump settings, such as aspiration and / or flushing rates, volumes, and / or frequencies. Furthermore, these systems and methods can collect and analyze biometric data (e.g., body temperature in patients with sepsis). The collected data can be used to guide treatment decisions. The system described herein can be housed in a separate, powered wearable component with a separate housing for electronics (such as pumps, circuit boards, and power supplies), sterile rinsing, and waste collection, as well as disposable components that allow for reuse.

[0045] refer to Figures 1A to 3C For illustrative and non-limiting purposes, the disclosed system 100 may be configured for percutaneous drainage. The system 100 may include a catheter 10, a drainage (also referred to as outflow, aspiration, and / or waste) tube 50, a flushing (also referred to as inflow) tube 51, a connector 52, a drainage (also referred to as outflow, aspiration, and / or waste) pump 30, a flushing (also referred to as inflow) pump 40, a controller 60, a waste collection container 70, and a flushing material container 71. The flushing material container 71 may include flushing material 72. The flushing material 72 may be saline or other suitable flushing material. For example, sterile normal (0.9%) saline may be used, containing or without one or more of the following: antimicrobial agents (such as antibiotics and antifungal drugs) or therapeutic enzymes (such as tissue plasminogen activator [tPA], streptococcal enzymes, collagenases, etc.). The system 100 may include a remote device 67 communicating with the controller 60. The waste collection container 70 may have a predefined baseline vacuum / negative internal pressure.

[0046] As described in more detail below, catheter 10 can be placed in the patient's drainage site 2. System 100 can drain fluid from drainage site 2 using a first lumen (e.g., drainage lumen 15 described below). System 100 can maintain the patency of the first lumen by (1) periodically delivering a local diluent using a second lumen (e.g., flushing lumen 16 described below), and / or (2) reversing the flow in the first lumen to clear obstructive debris, or both (simultaneously or not simultaneously).

[0047] The catheter 10 may include a catheter wall 11 extending from a proximal portion 12 of the catheter 10 to a distal portion 13 of the catheter 10. The distal portion 13 of the catheter 10 may be configured for placement in a drainage site 2. The catheter 10 may be a double-lumen catheter 10. For example, the catheter 10 may include a diaphragm 14 disposed within the catheter wall 11 and extending from the proximal portion 12 of the catheter 10 to the distal portion 13 of the catheter 10. A first portion of the catheter wall 11A and the diaphragm 14 may define a drainage lumen 15 (also referred to as an outflow, aspiration, and / or waste lumen), while a second portion of the catheter wall 11B and the diaphragm may define a flushing lumen 16 (also referred to as an inflow lumen). Each of the drainage lumen 15 and the flushing lumen 16 may extend from the proximal portion 12 of the catheter 10 to the distal portion 13 of the catheter 10. The volume ratio between the drainage lumen 15 and the flushing lumen 16 may be equal (i.e., 50-50). Figure 3A They can also be unequal, for example, 80-20, 70-30. Figure 3B ), 60-40 Figure 3B The lumens 10, or any other suitable proportion, can be used to achieve the desired flow dynamics. Although described as a specific type of double-lumen catheter (i.e., two lumens separated by a diaphragm), any suitable double-lumen catheter can be used, including, for example, catheters with coaxial lumens, or catheters with a diaphragm that is twisted along the longitudinal axis of the catheter, which may be linear, curved, or helical, or catheters with two parallel cylindrical or semi-cylindrical (or other shapes with flat edges) fused along their length, either straight or with the lumens twisted (interlaced) along the long axis of the catheter. As another example, the drainage lumen 15 or flushing lumen 16 can be incorporated into the catheter wall 11. Furthermore, the drainage lumen 15, flushing lumen 16, catheter wall 11, and diaphragm 14 can have any suitable shape to achieve the desired flow dynamics. The construction material of the catheter 10 can be any suitable material that is biocompatible and suitable for thermoplastic extrusion, a common method of constructing multi-lumen catheters. For example, the catheter 10 can be silicone, polyurethane, polyethylene, polyvinyl chloride, polytetrafluoroethylene, nylon, or a thermoresponsive polymer. The catheter wall can be non-woven and / or woven with filamentous material.

[0048] The diaphragm 14 may include at least one diaphragm aperture 17 (e.g., 17A-17F; also referred to as a window) along its length, such that the drainage chamber 15 and the flushing chamber 16 are in communication through the diaphragm aperture 17. For example, as Figure 2 As shown, for illustrative and non-limiting purposes, the diaphragm 14 may include six diaphragm holes 17. The diaphragm holes 17 may be located near the distal portion 13 of the catheter 10. The catheter wall 11 may include at least one wall hole 18 (e.g., 18A-D) along its length, such that when the distal portion 13 of the catheter 10 is placed within the drainage site 2, the drainage cavity 15 communicates with the drainage site 2. For example, as... Figure 2 As shown, for illustrative and non-limiting purposes, the catheter wall 11 may include four wall holes 18. The wall holes 18 may be located near the distal portion 13 of the catheter 10. Additionally or alternatively, the drainage lumen may have an open distal orifice to provide additional communication with the drainage site or to allow the catheter 10 to be delivered via a guidewire.

[0049] In one exemplary embodiment, the catheter 10 may include at least one wall hole 18 along its length in a second portion of the catheter wall 11B, such that the flushing chamber 16 communicates with the drainage site 2 when the distal portion 13 of the catheter 10 is placed within the drainage site 2. In such an embodiment, the diaphragm 14 may be without a diaphragm hole 17 or may have a diaphragm hole 17. Such a catheter 10 can be used to deliver enzymatic reagents and / or caustic reagents (e.g., detergent sclerosing agents) through the flushing chamber 16 to the injection site, which can cleave and / or otherwise break down the complex components of the fluid aggregate, and iatrogenically induce an inflammatory response within the chamber to promote scar formation and healing. The drainage chamber 15 can be used to collect and remove flushing material and potentially pathological fluids.

[0050] The wall hole 18 can be formed by any suitable means, such as punching, drilling, or laser. The diaphragm hole 17 can also be formed by any suitable means. When forming the diaphragm hole 17 and / or the wall hole 18, inert and durable inserts can be used to prevent damage to the interior of the conduit wall 11 or the diaphragm 14, as appropriate (e.g., where no opening is intended). The diaphragm hole 17 can be offset from the wall hole 18, for example, by inserting a perforating tool at an angle through the wall hole 18 into the diaphragm 14. For example, the diaphragm hole 17 can be created using a perforating tool suitable for passing through the wall hole 18. This creates diaphragm holes 17 that can guide flushing fluid back to the wall hole 18 (e.g., due to the relationship between diaphragm holes 17A, 17B and wall hole 18A). Furthermore, the diaphragm hole 17 can be cut at an angle so that it can guide flushing fluid back to the corresponding wall hole 18 located near the diaphragm hole 17. The diaphragm orifice 17 and the wall orifice 18 can be placed at any suitable location along the diaphragm 14 and the conduit wall 11, respectively, and can be of any suitable size or shape to provide the required flow dynamics, as described in more detail below. The dimensions of the wall orifice 18 and the diaphragm orifice 17 can vary along the length of the conduit 10. For example, the more distal diaphragm orifice 17 (e.g., 17A, 17B) can be larger than the more proximal diaphragm orifice 17 (e.g., 17E, 17F). This can maintain approximately equal flow rates through the diaphragm orifice 17 along the length of the conduit. Alternatively, it may be desirable to provide a higher fluid velocity through a particular diaphragm orifice. A higher flow rate through a particular diaphragm orifice will affect the patency of the corresponding or adjacent wall orifice. For example, the diameter of the diaphragm orifice 17 can gradually increase as fluid flows from the proximal portion 12 to the distal portion 13 of the conduit 10 in the flushing chamber 16. Additionally, the diameter of the distal diaphragm orifice 17 (e.g., 17A, 17B) can be smaller than that of the proximal diaphragm orifice 17 (e.g., 17E, 17F). Although specific examples have been described, any suitable diaphragm orifice 17 can be used to establish communication between the flushing chamber 16 and the drainage chamber 15, and any suitable wall orifice 18 can be used to establish communication between the drainage chamber 15 and the drainage site 2. Furthermore, achieving a higher flow rate at the wall orifices 18A and 18B facing the distal portion 13 of the conduit 10 may be desirable, as the wall orifices facing the distal portion 13 are more prone to clogging during use. Although specific diaphragm orifices 17 and wall orifices 18 have been described, any suitable diaphragm orifice 17 and wall orifice 18 can be used to achieve the desired flow dynamics. For example, orifices of various sizes, dimensional gradients along the length, and different shapes (e.g., elliptical, elongated, polygonal, circular) can be used. The orifice walls can be straight, tapered, circular, or curved. The orifices can be staggered or arranged in any direction along the conduit (e.g., spiral). An exemplary arrangement of the diaphragm holes 17 and the wall holes 18 will be described in more detail below.

[0051] The distal portion of the irrigation chamber 16 can be closed. For example, a distal plug 19 or other suitable means can be provided to close the distal portion of the irrigation chamber 16. The distal plug 19 can prevent the irrigation solution (e.g., a sterile solution) from leaving the distal end of the catheter 10 and can force the irrigation solution through the diaphragm orifice 17 into the drainage chamber 15. This can increase the pressure in the drainage chamber 15 and can clear material obstructing the drainage chamber 15 or the wall orifice 18. The irrigation solution can also dilute viscous body fluids to facilitate drainage of the drainage site 2. The distal plug 19 and / or the distal end of the catheter 10 can be rounded to facilitate insertion through tissue into the drainage site 2. Although a specific system for closing the distal portion of the irrigation chamber 16 has been described, any suitable means can be used to close the distal portion of the irrigation chamber 16. The distal portion of the drainage chamber 15 can be open, which can allow additional communication with the drainage site 2 and / or can be used for delivery using a guidewire, for example, via the Seldinger technique using an on-wire catheter.

[0052] The conduit 10 can have a straight, tail-like, annular, or other curved configuration. Combinations of one or more configurations / curvatures can be connected in series, and one or more configurations / curvatures can be repeated in series. The conduit 10 can be deformable to allow placement in a first configuration and then transition to a second configuration. For example, shape memory materials can be used to transition the conduit 10 to a second state to hold the conduit 10 in place.

[0053] According to the disclosed subject matter, catheter 10 may include a dimensional taper from a larger proximal portion 12 to a smaller distal portion 13, such that the body of the catheter can completely block the subcutaneous tunnel in the event that the distal portion 13 shifts from the drainage site 2. The tapered outer diameter also prevents leakage around the catheter. Additionally or alternatively, catheter 10 may include short-length ribs and / or grooved threads along its proximal midsection on its outer wall 11, which can allow a fixation device to anchor the catheter. For example, non-absorbable sutures can be used to secure the catheter to the skin without slipping along its length. Alternatively, an inflatable balloon, a mushroom-shaped silicone dome, a serrated ring, or a deployable T-staple that can slide along the length of the catheter to the skin opening can anchor catheter 10 to the subcutaneous soft tissue.

[0054] like Figure 1B As shown, for illustrative and non-limiting purposes, system 100A includes each of the components of system 100 and may also include a syringe injection port 53 coupled to flushing tubing 51 and a third tubing 54. The third tubing 54 may be coupled to syringe 55 (or a third pump and reservoir). Syringe 55 may be used to deliver a hardening agent, drug, or other adjunct to flushing tubing 51.

[0055] refer to Figures 4 to 6For illustrative and non-limiting purposes, system 100 may include a housing 80. The housing may be, for example, an enclosure for housing some or all of the electronic components of system 100. For example, housing 80 may house a drainage pump 30, a flushing pump 40, and a controller 60. Housing 80 may include a base 81 and a cover 82. Base 81 and / or cover 82 may include mounting members 83 (e.g., 83A, 83B) for supporting various electronic components. Mounting member 83 may be, for example, an M3 heat-set insert configured to receive an M3x10mm socket head cap screw (SHCS). Although specific mounting members are described, any suitable mounting member 83 may be used, such as screws, nails, or adhesives. Cover 82 may be fastened to base 81 by any suitable means, such as an M3x10mm SHCS. When fastened together, base 81 and cover 82 may form a protective and insulating housing 80 for the electronic components. The size and shape of the housing 80 allow it to be carried, for example, in a wearable bag (described in more detail below).

[0056] The drainage pump 30 and flushing pump 40 can be any suitable pump, such as a 6V peristaltic pump, and can be mounted within the housing 80. Similarly, the controller 60 can include any desired or suitable electronics, such as a microcontroller 61 (e.g., an Arduino Uno microcontroller), a motor driver 62 (e.g., an L298N motor driver), a battery 63 (e.g., a 200mAh 9.6V Ni-MH battery), and a transmitter 64 (e.g., an adafruit Bluefruit LE UART-Bluetooth Low Energy (BLE) transmitter), which can be mounted within the housing 80. Although specific components for the drainage pump 30, flushing pump 40, and controller 60 are described, any suitable components can be used. The housing 80 can also accommodate a test circuit board 65, for example, located on the cover 82. The test circuit board 65 can be used to deliver battery power from the battery 63 to the microcontroller 61 and motor driver 62, and can allow for the addition of modular, scalable off-board circuitry as needed. The housing 80 can also include a pressure sensor 66, which is attached to the drainage tube 50 via a T-connector connector 84. The housing 80 may include load sensors or level sensors at the flushing material container 71 and the waste collection container 70 to measure fluid volume and the flow rate of emptied fluid. The pressure sensor 66 may include a diaphragm seal and use a MEMS sensor.

[0057] The base 81 and cover 82 may each have slots 85 and 86 (respectively) that correspond to the positions of the drainage pump 30 and the flushing pump 40, and allow the drainage tube 50 and flushing tube 51 to pass through the base 81 and cover 82, such that the drainage tube 50 and flushing tube 51 can dock with the corresponding drainage pump 30 and flushing pump 40. For example, the drainage tube 50 may extend from the waste collection container 70 through the slot 86 of the cover 82, be routed to dock with the drainage pump 30, then through the T-connector 84, through the slot 85 in the base 81, and then through the connector 52 to be coupled to the drainage cavity 15 at the proximal portion 12 of the conduit 10. The flushing tube 51 may extend from the flushing material container 71 through the slot 85 of the cover 82, be routed to dock with the flushing pump 40, through the slot 85 of the base 81, and then through the connector 52 to be coupled to the flushing cavity 16 at the proximal portion 12 of the conduit 10.

[0058] refer to Figure 7 For illustrative and non-limiting purposes, battery 63 can provide power to one or more components disposed in housing 80. Battery 63 can be removed from housing, for example, for recharging or replacement. Battery 63 can be coupled to test circuit board 65. Switch 69 can be disposed between battery 63 and test circuit board 65 for connecting and disconnecting the device. On test circuit board 65, power can be distributed to transmitter 64, microcontroller 61, and motor driver 62.

[0059] Microcontroller 61 can be used to provide logic for transmitter 64, motor driver 62, drainage pump 30, flushing pump 40, and pressure sensor 66. For example, microcontroller 61 can be an Arduino Uno board and can be programmed in C++ within an Arduino integrated development environment (IDE). Microcontroller 61 can be coupled to pressure sensor 66 to receive pressure measurements from drainage tube 50. Microcontroller 61 can be coupled to transmitter 64 to send and receive information (e.g., receiving operating instructions and sending pressure or other measurements) to remote device 67, such as a computer (e.g., a laptop or desktop computer), personal data or digital assistant (PDA), or other user equipment or tablet, such as a mobile phone or portable media player. Communication between transmitter 64 and remote device 67 can be wired or via one or more of a network, radio frequency, or wireless connection (e.g., Bluetooth). Microcontroller 61 can also be coupled to motor driver 62, which can be coupled to each of drainage pump 30 and flushing pump 40. Therefore, the microcontroller can send control signals (e.g., in the form of digital signals) to the motor driver 62, and the motor driver 62 can send signals, such as pulse or step signals and direction signals (e.g., in the form of pump voltage) to the drainage pump 30 and the flushing pump 40. Although a specific arrangement has been described, any suitable arrangement can be used for the electronic components to achieve the desired drainage and flushing.

[0060] refer to Figure 8 For illustrative and non-limiting purposes, the housing 80 may be sized to fit within a wearable component 90, such as a belt-mounted pouch 91. The belt 92 may be adjustable and allow the patient to carry the system 100 relatively easily. The pouch 91 may be designed to mate with the housing 80 and may include holes or slots allowing the flushing tube 51 and waste tube 50 to extend through the pouch 91. Two external containers 93, 94 may be of various sizes and may be attached directly to the belt via a sheath or to an internal pocket of the pouch 91. The external containers 93, 94 may respectively house the flushing material container 71 and the waste collection container 70. Although a particular wearable component has been described, any suitable wearable component may be used.

[0061] In normal operation, conduit 10 can be delivered to drainage site 2. Instructions can be provided from microcontroller 61 via motor driver 62 to operate drainage pump 30 to engage drainage tube 50 and draw fluid from the drainage site through orifice 18, drainage chamber 15, and drainage tube 50 into waste collection container 70 (also referred to as drainage line). One-way (e.g., duckbill) valves can be used within the various components of the drainage line and / or at the joints to prevent backflow and / or leakage of waste fluid. During drainage, pressure sensor 66 can continuously (or intermittently) measure the pressure in drainage tube 50 and can provide a continuous voltage to microcontroller 61. Average values ​​can be obtained on a buffer, for example, 10 pressure sensor measurements at approximately 1000 Hz. If a blockage forms in the drainage path (i.e., in orifice 18, drainage chamber 15, or drainage tube 50), the average pressure value can rise above a threshold. This threshold can be, for example, a user-defined threshold. System 100 can recognize the increase in average pressure as indicating a blockage and can initiate a flushing operation. For example, microcontroller 61 can send a signal via motor driver 62 to stop drainage pump 30. Microcontroller 61 can also send a signal via motor driver 62 to start or increase flushing pump 40 to pump flushing fluid from flushing material container 71 through flushing tube 51, through flushing chamber 16, and through diaphragm orifice 17 (also called flushing line). Additionally or alternatively, microcontroller 61 can send a signal via motor driver 62 to reverse the direction of drainage pump 30. These actions can flush out blockages that may form in wall orifice 18, drainage chamber 15, and / or drainage tube 50. Microcontroller 61 can control the reverse flow rate in the drainage line; for example, the flushing volume can be programmed to be proportional to the length of drainage chamber 15 and drainage tube 50. This prevents the reintroduction of existing waste material into the body already residing in waste collection container 70. After performing the flushing operation, microcontroller 61 sends a signal via motor driver 62 to stop operation of flushing pump 40 and resume operation of drainage pump 30 to resume the drainage process. Another measuring buffer can be used to prevent multiple flushes in a short period of time while stabilizing the pressure reading. Figure 1B In system 100a, microcontroller 61 can further control syringe 55 (or third pump) to deliver additional solution (e.g., sclerosing agent / drug) into flush tube 51, into the flush line.

[0062] The remote device 67 can communicate with the transmitter 64 wirelessly (e.g., via Bluetooth). For example, the Adafruit Bluefruit library can be used. A companion application (e.g., for use on the Android operating system) can be developed in Java using Android Studio. This application allows Bluetooth connection to the microcontroller 65 (via the transmitter 64), enabling users (e.g., clinicians) to select and customize different device settings optimized for patient or medical conditions within the application. For example, pump speed, flushing frequency, and flushing volume can be adjusted using the application. Preset device configurations and settings for different medical conditions, tubing diameters, and catheter sizes can be specified as input within the application to improve ease of use and specificity. Furthermore, users can program a schedule to control the flushing frequency, allowing the catheter 10 to be flushed periodically even when no blockage is detected. The application also provides access to manual pump actions without detecting blockages, such as selecting when to flush the system or reverse the flow within the application. The application can be accessed via a graphical user interface 68 (…). Figures 9A to 9C Alternatively, it can be controlled by physical controls integrated with the hardware (such as a touchscreen).

[0063] Statistical data and information can be collected and stored within controller 60. For example, biometric and fluid drainage statistics (e.g., the volume of abscess drained, pressure generated during aspiration) can be collected and stored. Fluid drainage statistics can be used via an application to notify the user when the waste collection container or flushing material container is full or empty and when it needs to be replaced. Controller 60 can be reset before each use. Algorithms, such as regression equations, can be executed on microcontroller 65 to calculate how much abscess volume has been drained using pump speed and duration. This information can be transmitted to remote device 67 (e.g., via Bluetooth, Wi-Fi, cellular network, or radio frequency) and accessed by the user. This information can then be used for further diagnostics and additional and / or new instructions can be provided via remote device 67. For example, a slow and sustained decrease in pressure can indicate abscess collapse or healing, while a sudden increase in pressure can indicate possible blockage (e.g., fistula) or catheter malfunction. Therefore, an alarm can be provided to a healthcare provider.

[0064] Additional or alternative programmable components may be provided. For example, real-time simultaneous pumping, alternating pumping, pump function reversal, continuously varying high / low pressure settings, and sensor thresholds can allow for customization of pump behavior and settings. The suction / flushing settings can be configured to automatically adjust / adapt to the mechanical characteristics of waste fluid, obstructive lumen debris, and transduction pressure within drainage site 2. For example, the system can operate differently depending on the fluid to be drained, including air (emphysema), thin serous fluids (such as hematoma, urine, ascites, pleural effusion, cysts), medium-viscosity fluids (such as pus from abscesses / empyema, uninfected bile, infected urine), and viscous fluids (such as infected bile, liquefied seroma, excessively infected necrotic tissue, pancreatic pseudocysts, ruptured intestinal contents). For example, pressurized pulsed sterile saline irrigation can be used to flush complex collections and liquefy their contents.

[0065] Additionally or alternatively, an integrated suite of patient biometric sensors (e.g., body temperature, heart rate, blood pressure, blood glucose levels, hydration status, or other biometric information) may be provided, and may further influence system functionality. Real-time data may be transmitted to a HIPAA-safe website (in addition to or as an alternative to remote device 67), which may be monitored by the healthcare provider and may provide change notifications for significant changes in health status. For example, the rate of change of fluid flow rate, total aspirated fluid volume / time, catheter 10, and / or intracavitary pressure may be monitored and transmitted. Slow and gradual reduction in daily fluid output may indicate patient medical outcomes such as abscess clearance, clearance of pneumothorax without further leakage allowing for removal of a thoracic tube, patency of the cystic duct allowing for removal of a cholecystostomy tube, and patency of the ureter allowing for removal of a PCN / PCNU. Rapid increases in intracavitary pressure and flow resistance may indicate bleeding. Rapid decreases in intracavitary pressure may indicate fistula formation. Biofeedback data can be combined with artificial intelligence and machine learning techniques to better predict and manage the drainage function of specific types of fluid collections, anticipated drainage solutions, and patient health risk levels. While specific examples of data and methods for storing, transmitting, and using data are described, any suitable data can be measured, stored, transmitted, or relied upon.

[0066] According to the disclosed subject matter, pre-filled cartridges comprising chemical / enzymatic preparations that can be injected into the flushing line to dissolve debris within the lumen and / or antimicrobial agents can be provided. For example, tissue plasminogen activator (tPA), streptococcal enzymes, collagenases, sterile weak acid solutions, or one or more antibacterial / antifungal agents can be provided. Alternatively or additionally, catheter vibration via a high-frequency oscillator attached to catheter 10, an embedded piezoelectric crystal for acoustic interpretation, and / or other mechanisms can be used to maintain lumen patency. Comprehensive biological reagent detection can be provided to determine the specific chemical composition of the flushed waste fluid.

[0067] A reuse system with one or more conduits and / or one or more pumps

[0068] According to the disclosed subject matter, multiple catheters 10 can be provided to a single patient, and one or more control systems (e.g., a single CPU) can manage each catheter 10. For example, a patient can receive multiple drainage catheters, and a single central receiver can manage and / or coordinate the variable functions of each drainage catheter 10 (e.g., monitoring for blockages, determining when to flush, monitoring patient condition). Furthermore, the system can be modularly stacked, with one system assigned to each fluid collection, which minimizes the ergonomic burden on the patient and facilitates management.

[0069] refer to Figure 10 Individual patients with multiple individual abscesses 200A, 200B or a single multilocular abscess may require the insertion of multiple drainage catheters 10A, 10B for adequate fluid drainage. When this system is used to treat multiple individual abscesses or a single multilocular abscess, it can be reused to allow alternating drainage, either simultaneously aspirating and flushing multiple catheters or switching between catheters. This reuse capability allows a single system to automatically control multiple drainage and / or feeding catheters in a single patient via its controller logic, or to add more pumps to the system in a modular manner. For example, valve 103, illustrated as a three-way stopcock valve between catheters 10A and 10B, allows alternating drainage between two or more catheters draining multiple abscesses or a single complex abscess. Valve 103 can switch between first and second states. Figure 10 As shown, in a first state, fluid flows from the first abscess 200A through valve 103 to the waste collection container 70. In the first state, waste can be removed from the first abscess 200A but not from the second abscess 200B. In a second state (not shown), fluid flows from the second abscess 200B through valve 103 to the waste collection container 70. In the second state, waste can be removed from the second abscess 200B but not from the first abscess 200A. Additionally or alternatively, valve 103 is automatically operated by controller 60.

[0070] According to the disclosed subject matter, multiple pumps and / or valves can be regulated by a central control unit. For example, multiple drainage pumps and flushing pumps can be reused to allow simultaneous aspiration and flushing of multiple catheters, or alternating drainage switching between catheters. Alternatively or additionally, multiple valves can be switched under the control of the central control unit. The central control unit regulates the operation of multiple pumps and / or valves.

[0071] Regarding multiple pumps, multiple pumps can be plugged into a central control unit, which can then power and control each modular pump individually. (Reference) Figure 11 The central control unit 101 acts as a hub, providing power and coordinating the operation of each individual pump (102a, 102b, 102c, 102d). Individual pumps can be identified by unique numerical names to ensure that the correct individual pump is programmed accordingly and that the correct wiring (used for suction or flushing) is attached to the specific individual pump. Each individual pump can be attached to either the waste collection container 70 or the flushing material container 71, depending on its function. The central control unit 101 allows for independent programming of the individual pumps. Individual pumps (e.g., 102a, 102b) can be inserted into the central control unit 101 to receive power and communication via direct connection. Furthermore, individual pumps (e.g., 102c, 102d) can be inserted into pump 102a or 102b to receive power and communication transmitted through another pump. Additional pumps can be added according to the disclosed subject matter. For example, up to four individual pumps can be added to the system when two additional drainage tubes are added.

[0072] Regarding multiple valves, additional valves can be placed between the pump and the conduit. These multiple valves can be adjusted by the control unit 101, and the multiple valves can switch between two or more different states to serve two or more individual conduits. Depending on the valve's position, fluid flow can be allowed or blocked through the valve, thereby allowing variably applied suction or flushing to a single conduit. Return to Reference Figure 10 For illustrative and non-limiting purposes, the first abscess 200A is drained using suction generated by the peristaltic pump 102, and the valve 103 can be switched between two states indicated by the control unit 101. For example, the switching valve 103 can alternate between a first catheter 10A and a second catheter 10B placed in the first and second abscesses 200A and 200B, respectively. Alternatively or additionally, the peristaltic pump 102 can alternately perform pumping and periodic flushing, or flushing as required if a line blockage is detected in the line.

[0073] Experimental Results: The Effect of Periodic Flushing on Suction Performance

[0074] Based on the disclosed subject matter, the drainage performance of the system disclosed herein was compared using three different aspiration conditions. A catheter 10 with a flushing chamber 16, a drainage chamber 15, and a diaphragm orifice 17 was used to flush external drainage wall orifices (e.g., 18A-D) across a diaphragm 14. Flushing across the diaphragm 14 removes debris clogging at least one external drainage wall orifice 18A-D and locally dilutes abscess material to maintain the patency of the catheter 10. The catheter implemented herein was tested using three different aspiration conditions: (1) aspiration provided by a Uresil accordion-type aspiration bulb, (2) aspiration from a peristaltic pump only, and (3) aspiration with periodic flushing from a peristaltic pump. An abscess analogue composed of dairy products mixed with fruit was used. Under condition (3), when flushing was provided in addition to aspiration, 10 mL of water was flushed through the catheter every 2 minutes for 18 seconds by a second peristaltic pump. In addition, as a control, the disclosed catheter was tested with water under the three different aspiration conditions. All three aspiration conditions aspirated 100 mL (100 g) of water within 5 minutes (data not shown).

[0075] refer to Figure 12 The results of aspiration over 20 minutes using the drainage catheter disclosed herein are shown under three different aspiration conditions. Using the catheter disclosed herein, after 20 minutes of drainage of abscess analogues, the Uresil accordion bulb removed 4.0 ± 2.1 g of material, the peristaltic pump without flushing removed 61.0 ± 6.3 g of material, and the peristaltic pump with periodic flushing removed 81.4 ± 3.8 g of material. The peristaltic pump drained approximately 15 times more abscess material in the first 20 minutes compared to the accordion bulb. Within the same time period, using the same aspiration method, periodic flushing resulted in a 33% improvement. When the Uresil accordion bulb was used alone for aspiration and peristaltic aspiration (i.e., without flushing), rapid blockage of all four drainage holes was observed within this time period, followed by minimal effect from restarting the accordion bulb (data not shown). If the suction is still insufficient to pull the material through the four 2mm diameter drainage holes, the conduit will remain blocked, and drainage will stop or significantly decrease unless cleared by flushing.

[0076] Further reference Figure 12 The standard error is shown in the shaded area, and the average mass of drainage is shown for each of the three suction conditions. Regular flushing can remove obstructions from the external drainage orifice while locally diluting viscous substances. In current medical practice, flushing is performed manually and infrequently (e.g., every 8 hours). Increasing manual regular flushing is clinically impractical. However, as shown in this article, automated regular flushing of the external drainage orifice using a multi-lumen catheter with a septal orifice can improve drainage at the same suction pressure.

[0077] Computational Fluid Dynamics (CFD) Analysis and Results: Conduit Structure Evaluation

[0078] Based on the disclosed subject matter, computational fluid dynamics (CFD) analysis was performed on the disclosed catheter to evaluate different catheter structures without requiring a physical prototype. CFD can determine the parameters of a flushing flow profile that is uniformly distributed throughout the external drainage wall orifices. Since blockages can occur irregularly throughout the external drainage orifices or diaphragm of the catheter, it is important to flush uniformly along the entire length of the catheter to minimize the probability of blockages that could lead to catheter failure.

[0079] For example, through iterative simulation prototyping, the flushing performance of different catheters was rapidly modeled and evaluated by measuring the flow rate at the external drainage and diaphragm orifices. All 3D models of the dual-lumen catheter were created using the 3D parametric modeling software Fusion 360 (Autodesk, San Rafael, CA, United States). The structural features of the catheter were parametrically manipulated using the geometry modifier to generate the catheter's structural concept. References Figure 13 The original baseline catheter structure (Concept A) consists of a dual-lumen channel with four external drainage wall holes 18a-18d (2 mm in diameter) spaced 13 mm apart and aligned with the wall holes 18a-18d. The distal end of the catheter 10 may be tapered, with a small opening mimicking the guide hole commonly found in multipurpose drainage catheters. The distal opening 21 allows direct communication with the waste chamber 15 and indirect communication with the flushing chamber 16. In CFD analysis, fluid flow through the distal opening 21 is neglected because its size and location only slightly affect the hydrodynamics.

[0080] Refer again Figure 1A The conduit 10 has two reversible pumps attached to the flushing chamber and the waste chamber, which can be controlled independently. A typical flushing action can be combined with a brief reversal of the suction pump at the same fluid velocity to generate a larger positive flow rate at the wall orifices 18a-18d, and thus pressure to remove debris. Regarding... Figure 15 The baseline conduit concept A structure was used to compare various flushing and / or suction pumping techniques. CFD was used to perform brine flushing only, simultaneous brine flushing and suction pump reversal, and the CFD differences were quantified. Furthermore, at twice the flushing rate, simultaneous flushing and suction pump reversal were compared with brine flushing only to measure how the average flow velocity at orifices 18a-18d was compared when the flushing fluid flow was (a) separated between waste chamber 15 and flushing chamber 16, or (b) only in flushing chamber 16. Simultaneous operation of the flushing and suction pumps was used to analyze all subsequent structural modifications.

[0081] Subsequent structural modifications to the catheter geometry improved flushing performance. These modifications included aligning the diaphragm orifice with the distal orifice, changing the diaphragm orifice diameter, and adjusting the cross-sectional areas of the waste chamber and flushing chamber. All concepts were compared to a baseline catheter design (Concept A) to evaluate the increase / decrease in orifice fluid velocity during flushing. Table 1 summarizes the various catheter designs tested.

[0082] Regarding concepts B and C, the positions of the diaphragm orifices 17a-17d are staggered relative to the wall orifices 18a-18d along the conduit. It is hypothesized that fluid interference at the junction between the flushing fluid and the waste chamber can be compensated for by alternative positioning, thereby improving the wall orifice flow rate. Regarding concepts D and E, the diameters of the diaphragm orifices 17a-17d are altered, increasing the diameter from the diaphragm orifice 17d in the proximal portion 12 to the diaphragm orifice 17a in the distal portion 13. Furthermore, in concepts F and G, the volume ratio of the waste chamber to the flushing chamber is increased to investigate whether the enhanced Venturi effect can improve flushing. The conduit structure for concept AG is provided in Table 1.

[0083]

[0084]

[0085] Table 1. Summary of structural changes relative to the baseline catheter (Concept A).

[0086] CFD analysis was performed on the conduit of the concept BG to simulate changes in volume ratio, diaphragm pore diameter, and diaphragm pore position.

[0087] CFD methods and procedures

[0088] For CFD analysis, the 3D CAD model of the proposed conduit design was imported into OpenFOAM CFD software (OpenFOAM Foundation, UK). In OpenFOAM, a finite element model of the conduit concept AG was generated at approximately a 5:1 scale. Scaled models are a common method to reduce simulation complexity and shorten the time required to complete CFD simulations. The hydrodynamics of the flushing phase of the device were visualized and quantified in all conduit design concepts. A simple steady-state fluid flow simulation was performed on the conduit concept AG in OpenFOAM. [About...] Figure 14The finite volume method was applied to solve the basic Navier-Stokes equations and visualize the streamlines. In these simulations, only the mass and momentum conservation equations were applicable, as heat transfer was not assumed. The homogeneous liquid properties of water were used at both inlets, assuming an incompressible liquid flow rate. The flushing inlet velocity was capped at 1.5 cm / s for the flushing flow rate. This 1.5 cm / s flushing inlet velocity was doubled at the waste chamber inlet when checking for reverse flushing and suction pump reversal. The duct performance between the design concepts was evaluated by measuring the steady-state fluid velocity at the outlet during flushing. Specifically, the average fluid velocity across the surface area of ​​the external drainage wall orifices 18a–18d was calculated.

[0089] Iterative CFD Comparative Analysis: Saltwater Flushing Simulation

[0090] about Figure 15 As shown in Table 2, in the brine flushing simulation, the velocities (18a-18d) of all orifices simultaneously flushing and pump reversal were significantly increased compared to flushing only. Fluid flow rates in orifices 18d, 18c, 18b, and 18a increased by 147%, 102%, 79%, and 82%, respectively. Flushing and pump reversal approached the flow rates observed during brine flushing, which were twice the initial fluid velocity. The decrease between these two conditions was less than 16% in all orifices. Therefore, all subsequent CFD design evaluations will use only the brine flushing and waste removal mechanism. Table 2 shows the values ​​used for... Figure 15 The results of the three baseline catheters (Concept A) in the test are presented in Table 2. The baseline catheters were analyzed with saline flushing only in the drainage lumen, with saline flushing and aspiration simultaneously (i.e., fluid flow reversal), and with saline flushing only at twice the speed.

[0091]

[0092] Table 2 - CFD results of saline flushing and / or simultaneous pump simulation of baseline catheter (Concept A).

[0093] Iterative CFD Comparative Analysis: Diaphragm Pore Displacement (Concept B and Concept C)

[0094] about Figure 16According to Table 3, the diaphragm orifices 17a-17d were shifted towards the proximal portion 12, and catheter performance was reviewed. Compared to baseline catheter concept A, shifting the diaphragm orifices 17a-17d towards the proximal portion 12 by 1.0 mm in catheter concept B increased the fluid velocity in all outlet wall orifices 18a-18d. In catheter concept C, shifting the diaphragm orifices 17a-17d towards the proximal portion 12 by 6.5 mm increased the fluid velocity in the nearest end wall orifices 18d and 18c, but decreased the fluid velocity in the most distal end wall orifices 18b and 18a. Regarding Table 3, the fluid velocity changes through outlet wall orifices 18d, 18c, 18b, and 18a were +43%, +17%, -2%, and -13%, respectively. In concept B, the largest increase in fluid velocity, at outlet 18d, was observed, increasing by 15%.

[0095]

[0096] Table 3 -- Flow velocities of the wall orifices in conceptual conduit structures B and C compared to the baseline conduit (concept A): Fluid velocities in diaphragm orifices 18a-18d compared to baseline conduit concept A with those in diaphragm orifices (e.g., 17a-17d); Figure 13 It changes as it shifts toward the proximal portion 12.

[0097] Iterative CFD Comparative Analysis: Diaphragm Pore Diameter Modification (Concepts D and E)

[0098] about Figure 17 According to Table 4, the diameters of the diaphragm orifices 17a-17d were modified in concepts D and E, and the CFD results were evaluated. In catheter concept D, the diameters of the diaphragm orifices 17d, 17c, 17b, and 17a were changed from 1 mm (the baseline diameter for all diaphragm orifices) to 1 mm, 1.5 mm, 2 mm, and 3 mm, respectively. Compared to baseline catheter concept A, the fluid velocity at the nearest end-wall orifices 18d and 18c increased in catheter concept D, but decreased at the farthest end-wall orifices 18b and 18a. In catheter concept E, the diameters of the diaphragm orifices 17d, 17c, 17b, and 17a were changed to 0.5 mm, 0.75 mm, 1 mm, and 1.5 mm, respectively. In concept E, a decrease in fluid velocity was observed at the nearest end-wall orifices 18d (41%) and 18c (16%), but a significant increase in fluid velocity was observed at end-wall orifice 18a (37%). As described above, the orifice 18 can become blocked during drainage. The orifice 18 facing the distal portion 13 of the catheter may be more easily blocked than the orifice 18 facing the proximal portion 12 of the catheter. Therefore, the orifice diameter can be specified to produce an increased fluid velocity towards the distal portion 13 of the catheter. Increasing the fluid velocity at the diaphragm orifice 17 and / or the orifice 18 can help clear obstructing material and maintain catheter patency.

[0099]

[0100] Table 4 – Conceptual conduit structures D and E, with variations in diaphragm orifice diameter. Comparison of wall orifice flow velocities in concepts D and E with a baseline conduit (concept A) having diaphragm orifices of the same size.

[0101] Iterative CFD comparative analysis: changing the volume ratio of the drainage chamber and the flushing chamber (concepts F and G)

[0102] about Figure 18 As per Table 5, CFD comparative analyses were performed on structures in catheter concepts F and G that included different volume ratios between the waste chamber 15 (i.e., the drainage chamber) and the flushing chamber 16. In the structure with a drainage-flushing ratio of 60:40 (concept F), the fluid velocity differences in all orifices were minimal. Only orifice 18b showed a fluctuation of 0.01 cm / s. However, the structure with a drainage-flushing ratio of 80:20 (concept G) showed a greater impact on the fluid velocity in the orifices. Compared to the baseline catheter, orifices 18d and 18c in concept G decreased by 21% and 7%, respectively, while orifices 18b and 18a increased by 2% and 13%, respectively.

[0103]

[0104] Table 5 – Flow velocities in the wall orifices of conceptual catheter structures F and G compared to a baseline catheter (Concept A) with a drainage-flushing ratio of 50:50: Variation of diaphragm orifice diameter in concept FG compared to baseline catheter concept A with drainage and flushing cavities of the same size.

[0105] Iterative CFD Comparative Analysis: Adding Outward Flushing Holes (Concept H) to Reduce Orifice Flow Velocity

[0106] about Figure 19 As per Table 6, a CFD comparative analysis was performed on catheter concept H, which included diaphragm orifices 17a-17d and outward flushing orifices 22a-22d, using only flushing. It was assumed that including outward flushing orifices 22a-22d would allow for more direct flushing of the abscess cavity. However, CFD analysis of concept H with outward flushing orifices 22a-22d showed a significant decrease in the flow rate of the flushing fluid through the wall orifices 18a-18d. Specifically, compared to concept A, which had diaphragm flushing orifices (but no outward flushing orifices 22a-22d), the fluid flow rate at the wall orifices 18a-18d in concept H was reduced by more than 40%. Therefore, including both inward and outward flushing orifices results in a decrease in the fluid velocity through the wall orifices 18a-18d and increases the likelihood of draining obstructive debris at the wall orifices 18a-18d.

[0107]

[0108] Table 6—Conceptual conduit structure H with outward flushing holes compared to baseline conduit (Concept A): The addition of outward flushing holes 22a-22d reduces the fluid flow rate at drainage wall holes 18a-18d.

[0109] about Figure 20 A CFD comparative analysis was performed on conduit concept I, including the distal orifice, in accordance with Table 7. It was assumed that the fluid flow rate from the distal orifice was negligible. The CFD analysis of concept I with the distal orifice revealed that, in the comparison between baseline conduit concept A and concept I with the distal orifice, the decrease in fluid velocity through the wall orifices 18a-18d was minimal and proportional. Therefore, the effect of the distal orifice on the fluid velocity through the wall orifice and the corresponding CFD analysis can be considered negligible.

[0110]

[0111] Table 7—Conceptual conduit structure I with distal orifice has a negligible effect on the flow velocity in the wall orifice.

[0112] Discussion of CFD results

[0113] Using parametric CAD modeling and CFD software, physics-based simulations can be used to rapidly analyze and iterate on conduit structure concepts. Various concepts can be tested to maximize the fluid velocity uniformly passing through all wall orifices 18a-18d, and CFD results can be compared.

[0114] By incorporating a brief pump reversal during the flushing action, this structural change can result in a significant increase in fluid velocity through all orifices compared to flushing alone. While orifice 18d exhibits the largest velocity increase (147%), the fluid velocities in all other orifices nearly double compared to flushing alone. Flushing with simultaneous pump reversal can be almost as effective as hypothetical brine flushing, with a flushing velocity twice the initial velocity and minimal fluid velocity loss (less than 17%) due to fluid disturbances at the cavity joints. Therefore, this concept can be adopted into the final structure and applied to fully ensure CFD simulations.

[0115] Observations have shown that many internal catheter modifications can improve overall fluid flow, but only when parameters are carefully tailored. In suboptimal designs, such as shifting the orifice by approximately 6.5 mm or increasing the septum orifice diameter by 0.5–1.5 mm, the fluid velocity generated at the wall orifices decreases in some but subsequently increases in the rest. These structural changes can only divert fluid flowing through the wall orifices without significantly reducing fluid interference. Conversely, shifting the septum orifice by 1 mm improves the velocity across all wall orifices. These structural changes redirect fluid flow along a more optimized path, thereby minimizing fluid interactions. Enlarging the septum orifice along the septum primarily increases the fluid velocity in the most distal orifice, while shifting the septum orifice proximally primarily improves the fluid velocity at the nearest wall orifice. Furthermore, the catheter concept G with an 80:20 drainage-to-irrigation ratio provides drainage benefits during standard abscess removal procedures. The flushing intensity will be slightly affected due to a decrease in fluid velocity of 0.20 m / s (21%) in orifice 18d, and an increase in fluid velocity of 0.18 m / s (13%) was observed in orifice 18a. CFD analysis indicates that changes in the internal structure of the catheter lead to significant hydrodynamic changes in the double-lumen catheter during flushing.

[0116] Considerations and limitations of CFD analysis include the assumption that the fluid is homogeneous, while in clinical use scenarios, the waste chamber may contain more viscous materials. Furthermore, transient fluid interactions at startup are largely neglected in this steady-state analysis. It is presumed that rapid fluid velocities will quickly achieve steady-state flow within a relatively small catheter volume. These limitations of steady-state CFD analysis are complemented by physical benchtop testing. Although these limitations affect the fidelity of CFD results, these results still provide reasonable and practical knowledge during the virtual rapid prototyping phase without requiring the construction of numerous expensive prototypes.

[0117] Additional operating conditions and structural parameters can further improve flushing. For example, the intensity of the flushing and / or suction pumps can be adjusted to manipulate the fluid velocity profile. During the CFD analysis, only the flushing phase of the conduit was analyzed. However, the conduit can perform several different actions, such as flushing to clean the waste chamber while simultaneously draining it.

[0118] Methods for percutaneous drainage

[0119] Figure 21An example of a method 1000 for percutaneous drainage of a drainage site is shown. The method 1000 may begin at step 1100, wherein the method includes inserting a catheter into the drainage site. The catheter includes: a catheter wall extending from a proximal portion of the catheter to a distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; a septum disposed within the catheter wall and extending from the proximal portion of the catheter to the distal portion of the catheter; a drainage lumen defined by a first portion of the catheter wall and the septum, extending from the proximal portion of the catheter to the distal portion of the catheter; and an irrigation lumen defined by a second portion of the catheter wall and the septum, extending from the proximal portion of the catheter to the distal portion of the catheter, wherein the irrigation lumen is separated from the drainage lumen by the septum. The diaphragm has at least one diaphragm orifice disposed therein near the distal portion of the catheter, such that a drainage cavity and a flushing cavity communicate through the at least one diaphragm orifice; and wherein the catheter wall has at least one wall orifice disposed therein near the distal portion of the catheter, such that the drainage cavity communicates with the drainage site when the distal portion is placed within the drainage site. In step 1200, the method may include aspirating fluid from the drainage site through the drainage cavity. In step 1300, the method may include identifying an obstruction in the drainage cavity. In step 1400, the method may include flushing with flushing fluid through the flushing cavity and into the drainage cavity through the at least one diaphragm orifice, thereby eliminating the obstruction. According to the disclosed subject matter, the method can be repeated as appropriate. Figure 21 One or more steps of the method. Although this disclosure describes and illustrates that they occur in a particular order. Figure 21 The specific steps of the method are described, but this disclosure considers the possibility of them occurring in any suitable order. Figure 21 Any suitable steps of the method. Furthermore, although this disclosure describes and illustrates including... Figure 21 This disclosure describes one example of a method for percutaneous drainage of a drainage site, including specific steps, but contemplates any suitable method for percutaneous drainage of a drainage site that includes any appropriate steps, which may, where appropriate, include... Figure 21 All, some, or none of the steps of the method Figure 21 Any steps of the method. Furthermore, although this disclosure describes and illustrates the implementation... Figure 21 The method may refer to a specific component, apparatus, or system of a specific step, but this disclosure is contemplated for the execution of... Figure 21 Any suitable step of the method, any suitable component, device, or system, or any suitable combination thereof.

[0120] In cases where system 100 is used for percutaneous thoracotomy, the sensor / microcontroller system can be further programmed to detect the presence, persistence, and / or elimination of pneumothorax, air leaks, and / or bronchopleural fistulas. In cases where system 100 is used for percutaneous chemical ablation and / or sclerosing cystic lesions, recurrent effusion accumulation (e.g., lymphocytic cysts and other diseases of the lymphatic system), and / or hollow viscera (e.g., the gallbladder of a patient deemed unsuitable for cholecystectomy), the system can monitor the volume of injected sclerosing agent / polymer gel, indwelling time, flushing, simultaneous or delayed aspiration, and repeated circulation. In this use, catheter 10 may have side holes along its outer wall 11 on both sides, without a diaphragmatic orifice 17. In cases where the system is used for percutaneous esophagostomy-gastrostomy, gastrojejunostomy, jejunostomy, and / or cecumostomy (i.e., the digestive tract), the system may include programmable tube feeding settings for patient-specific nutritional needs and tube flushing settings for maintaining lumen patency.

[0121] Enteral feeding

[0122] about Figure 22 System 100C is configured for use with enteral feeding catheters (e.g., intestinal tubes 72) such as those used in gastrostomy, gastrojejunostomy, or jejunostomy. For example, an indwelling percutaneous gastrostomy catheter 71 can be used to deliver a liquid nutrition formula to the stomach via a peristaltic pump 102a from a container 73. A pressure sensor 75, mounted along the tubing between the container 73 and the indwelling percutaneous gastrostomy catheter 71, can detect lumen obstruction due to feed agglomerates or other particulate matter. In the event of obstruction, control unit 60 activates a second peristaltic pump 102b attached to a container 74 filled with sterile water or saline, enabling dynamic flushing and restoration of lumen patency. Flushing can also be scheduled periodically at preset volumes and pressures for tubing maintenance. An optional syringe pump 76 allows each intestinal tube 72 to be administered a prescribed medication.

[0123] Although the disclosed subject matter is described herein with reference to certain preferred embodiments for illustrative and not limiting purposes, those skilled in the art will recognize that various modifications and improvements can be made to the disclosed subject matter without departing from its scope. Furthermore, although various features of one embodiment of the disclosed subject matter may be discussed herein or illustrated in the accompanying drawings of one embodiment rather than in other embodiments, it should be readily apparent that various features of one embodiment may be combined with one or more features of another embodiment or features from multiple embodiments.

[0124] In addition to the specific embodiments claimed below, the disclosed subject matter also relates to other embodiments having any other possible combinations of the dependent features claimed below and the features disclosed above. Therefore, the specific features set forth in the dependent claims and disclosed above can be combined with each other in other possible combinations. Thus, the above description of specific embodiments of the disclosed subject matter is given for illustrative and descriptive purposes only and is not intended to be exhaustive or to limit the disclosed subject matter to those embodiments.

[0125] It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and systems disclosed without departing from the spirit or scope of the disclosed subject matter. Therefore, the disclosed subject matter is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A system for percutaneous drainage of a drainage site, comprising: The catheter has: The catheter wall extends from the proximal portion of the catheter to the distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; A diaphragm is disposed within the wall of the catheter and extends from a proximal portion of the catheter to a distal portion of the catheter, wherein the distal portion includes the distal end of the catheter, and the diaphragm extends completely to the distal end of the catheter. A drainage lumen, defined by a first portion of the catheter wall and the septum, and extending from a proximal portion of the catheter to a distal portion of the catheter; and A flushing chamber, defined by a second portion of the catheter wall and the diaphragm, and extending from a proximal portion of the catheter to a distal portion of the catheter, wherein the flushing chamber is separated from the drainage chamber by the diaphragm; A drainage tube having a first end coupled to the drainage cavity at the proximal portion of the conduit and a second end coupled to a waste collection container; A first pump is coupled to the drainage tube between a first end and a second end of the drainage tube; A flushing tube having a first end coupled to the flushing chamber at the proximal portion of the conduit and a second end coupled to a flushing material container in which flushing material is disposed; A second pump, the second pump being coupled to the flushing tube between a first end and a second end of the flushing tube; and A controller, coupled to the first pump and the second pump, for controlling the first pump and the second pump; The diaphragm has a plurality of diaphragm holes along the longitudinal axis of the catheter, and the plurality of diaphragm holes are positioned near the distal portion of the catheter, such that the drainage cavity and the flushing cavity are connected through the plurality of diaphragm holes; The catheter wall has a plurality of wall holes along the longitudinal axis of the catheter, and the plurality of wall holes are configured to be close to the distal portion of the catheter, such that when the distal portion of the catheter is placed in the drainage site, the drainage cavity communicates with the drainage site. Each of the plurality of wall holes has a corresponding diaphragm hole among the plurality of diaphragm holes; and Each wall hole is aligned with its corresponding diaphragm hole along the longitudinal axis, such that the positional distance of each wall hole relative to its corresponding diaphragm hole along the longitudinal axis is 0 mm to 6.5 mm.

2. The system of claim 1, wherein, The volume of the drainage cavity is equal to the volume of the flushing cavity.

3. The system according to claim 1, wherein, The volume of the drainage cavity is larger than the volume of the flushing cavity.

4. The system according to claim 1, wherein, The plurality of diaphragm pores include a distal pore with a first diameter and a proximal pore with a second diameter, the second diameter being different from the first diameter.

5. The system according to claim 4, wherein, The second diameter is smaller than the first diameter.

6. The system of claim 1 further includes a pressure sensor coupled to the drainage tube and the controller.

7. The system according to claim 1 further includes a housing, wherein the first pump, the second pump and the controller are disposed in the housing.

8. The system of claim 1 further includes an injection port coupled to the flushing tube.

9. The system of claim 8 further includes a syringe coupled to the injection port via a third tube.

10. The system of claim 8 further includes a third pump coupled to the injection port via a third tube.

11. The system according to claim 1, wherein, The drainage cavity has an opening at the distal end of the catheter for delivering a guidewire.

12. The system according to claim 1, wherein, The flushing chamber does not have external wall holes.

13. The system according to claim 1, wherein, The volume ratio between the drainage chamber and the flushing chamber is 60:

40.

14. The system according to claim 1, wherein, The volume ratio between the drainage chamber and the flushing chamber is 70:

30.

15. The system according to claim 1, wherein, The volume ratio between the drainage chamber and the flushing chamber is 80:

20.

16. The system according to claim 1, wherein, The distal portion of the flushing chamber is sealed by a distal plug.

17. A catheter for percutaneous drainage at a drainage site, comprising: The catheter wall extends from the proximal portion of the catheter to the distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; A diaphragm is disposed within the wall of the catheter and extends from a proximal portion of the catheter to a distal portion of the catheter, wherein the distal portion includes the distal end of the catheter, and the diaphragm extends completely to the distal end of the catheter. A drainage lumen, defined by a first portion of the catheter wall and the septum, and extending from a proximal portion of the catheter to a distal portion of the catheter; and A flushing chamber, defined by a second portion of the catheter wall and the diaphragm, and extending from a proximal portion of the catheter to a distal portion of the catheter, wherein the flushing chamber is separated from the drainage chamber by the diaphragm; The diaphragm has at least one diaphragm hole, which is located near the distal end of the catheter, so that the drainage cavity and the flushing cavity are connected through the at least one diaphragm hole. The catheter wall is provided with at least one wall hole, which is close to the distal portion of the catheter, such that when the distal portion is placed in the drainage site, the drainage cavity communicates with the drainage site. Each wall hole has a corresponding diaphragm hole; and Each wall hole is aligned with its corresponding diaphragm hole along the longitudinal axis, such that the positional distance of each wall hole relative to its corresponding diaphragm hole along the longitudinal axis is 0 mm to 6.5 mm.

18. The catheter according to claim 17, wherein, The volume of the drainage cavity is equal to the volume of the flushing cavity.

19. The catheter according to claim 17, wherein, The volume of the drainage cavity is larger than the volume of the flushing cavity.

20. The catheter according to claim 17, wherein, The at least one diaphragm pore includes a plurality of diaphragm pores.

21. The catheter according to claim 17, wherein, The at least one diaphragm pore includes a distal pore with a first diameter and a proximal pore with a second diameter, the second diameter being different from the first diameter.

22. The catheter according to claim 21, wherein, The second diameter is smaller than the first diameter.

23. The catheter according to claim 17, wherein, The at least one diaphragm hole and the at least one wall hole are offset.

24. The catheter according to claim 17, wherein, The drainage cavity has an opening at the distal end of the catheter for delivering a guidewire.

25. A system for percutaneous drainage of a drainage site, comprising: The catheter has: The catheter wall extends from the proximal portion of the catheter to the distal portion of the catheter, the distal portion of the catheter being configured for placement within the drainage site; A diaphragm is disposed within the wall of the catheter and extends from a proximal portion of the catheter to a distal portion of the catheter, wherein the distal portion includes the distal end of the catheter, and the diaphragm extends completely to the distal end of the catheter. A drainage lumen, defined by a first portion of the catheter wall and the septum, and extending from a proximal portion of the catheter to a distal portion of the catheter; and A flushing chamber, defined by a second portion of the catheter wall and the diaphragm, and extending from a proximal portion of the catheter to a distal portion of the catheter, wherein the flushing chamber is separated from the drainage chamber by the diaphragm, wherein the diaphragm has a plurality of diaphragm holes along the longitudinal axis of the catheter; A drainage tube having a first end coupled to the drainage cavity at the proximal portion of the conduit and a second end coupled to a waste collection container; A first pump is coupled to the drainage tube between a first end and a second end of the drainage tube; A flushing tube having a first end coupled to the flushing chamber at the proximal portion of the conduit and a second end coupled to a flushing material container in which flushing material is disposed; A second pump, the second pump being coupled to the flushing tube between a first end and a second end of the flushing tube; and A controller, coupled to the first pump and the second pump, for controlling the first pump and the second pump; Wherein, at least one first wall hole is provided in the first part of the catheter wall, the first wall hole being close to the distal part of the catheter, such that when the distal part of the catheter is placed in the drainage site, the drainage cavity communicates with the drainage site; The second portion of the catheter wall is provided with at least one second wall hole, which is close to the distal portion of the catheter, such that when the distal portion of the catheter is placed in the drainage site, the flushing chamber communicates with the drainage site. Each wall hole has a corresponding diaphragm hole from the plurality of diaphragm holes; and Each wall hole is aligned with its corresponding diaphragm hole along the longitudinal axis, such that the positional distance of each wall hole relative to its corresponding diaphragm hole along the longitudinal axis is 0 mm to 6.5 mm.

26. The system according to claim 25, wherein, The drainage cavity has an opening at the distal end of the catheter for delivering a guidewire.

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