System and method for percutaneous drainage

Abstract

To provide a system for percutaneous drainage of a drainage site.SOLUTION: A system for percutaneous drainage of a drainage site includes a catheter, a drain tube, a first pump, a flush tube, a second pump, and a controller. The catheter includes a drain lumen defined by a first portion of the catheter wall and the septum, and a flush lumen defined by a second portion of the catheter wall and the septum and separated from the drain lumen by the septum. The septum has at least one septum hole disposed therein such that the drain lumen and the flush lumen are in communication via the at least one septum hole. The catheter wall has at least one wall aperture disposed therein such that the drain lumen is in communication with the drainage site when the distal end portion of the catheter is disposed within the drainage site.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS 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 from which priority is claimed.

[0002] (Areas to be disclosed) The disclosed subject matter is directed to systems and methods for percutaneous drainage, for example, to evacuate abnormal, possibly infected, fluid collections from the body. [Background technology]

[0003] Pathological fluids can accumulate in the body due to infection / inflammation (i.e., abscesses), visceral obstruction / perforation (i.e., urinary or bile duct obstruction), and / or bleeding (i.e., hematomas). Fluids can be drained using image-guided percutaneous drainage systems. For example, using computed tomography (CT), ultrasound (US), and / or fluoroscopy (XR) guidance, a physician (e.g., an interventional radiologist) can noninvasively visualize the abnormal fluid collection and then insert a drainage catheter through the skin into the collection using minimally invasive techniques. Drainage catheters are hollow plastic tubes of variable length and lumen diameter; the most commonly used type is known as a "pigtail" catheter, named for the loop shape formed at its distal end. Drainage catheters function by having one or more side holes at their distal end through which abnormal fluids can enter the catheter's lumen and be collected in a bag attached to its proximal end. Drainage can occur under gravity or intermittently applied bubble suction. The average dwell time of a drainage catheter can be approximately 28 days, and device failure secondary to lumen obstruction / blockage by viscous fluids and / or particulate matter can occur approximately 25–30% of that time, regardless of tubing diameter. Poor drainage can lead to recurrence of patient disease and the need for repeated invasive procedures to prevent sepsis-related deaths, potentially incurring additional risks and costs. Studies have shown that up to 85% of drainage catheters require at least one exchange before removal, and 50% may be oversized, despite the larger diameter not providing a significant advantage in lumen patency or required dwell time.

[0004] To help maintain lumen patency, healthcare providers, as well as patients and / or caregivers, may be instructed to manually infuse a prescribed volume of sterile saline into the catheter at a scheduled frequency. This can increase lumen lubrication, remove debris from the catheter wall and sidewall pores, and reduce the viscosity of the drain fluid. However, this intervention is not always effective, and non-compliance with instructions is a common problem. Forgetting to flush the catheter, infusing too little or too much fluid, and using unsterile tap water instead of sterile saline are common causes of catheter blockage, delayed healing, and further complications, such as catheter-related superficial or deep tissue infections.

[0005] Furthermore, patients commonly report negative psychosocial impacts from living with one or more drainage catheters for extended periods of time: the tubes and waste collection bags can be physically cumbersome, uncomfortable, unsightly, and socially stigmatizing.

[0006] Therefore, there is a need for improved systems and methods for percutaneous drainage. Summary of the Invention

[0007] The objects and advantages of the disclosed subject matter will be set forth in and apparent from the following description, as well as be learned by practicing the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the description and claims hereof, as well as the appended drawings. [Means for solving the problem]

[0008] To achieve these and other advantages, and in accordance with the objectives of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter is directed to a system and method for percutaneous drainage. For example, a system for percutaneous drainage of a drainage site includes a catheter, a drain tube, a first pump, a flush tube, a second pump, and a controller. The catheter includes a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter disposed within the drainage site, a septum extending from the proximal end portion of the catheter disposed within the catheter wall to the distal end portion of the catheter, a drain lumen defined by the catheter wall and a first portion of the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter, and a flush lumen defined by a second portion of the catheter wall and the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter, the flush lumen being separated from the drain lumen by the septum. The drain tube has a first end coupled to the drain lumen at the proximal end portion of the catheter and a second end coupled to a waste collection container. The first pump is coupled to the drain tube between the first end and the second end of the drain tube. The flush tube has a first end coupled to the flush lumen at the proximal end portion of the catheter and a second end coupled to a flush material container having a flush material disposed therein. The second pump is coupled to the flush tube between the first end and the second end of the flush tube. A controller is coupled to the first pump and the second pump for controlling the first pump and the second pump. The septum has at least one septum hole disposed therein adjacent to the distal end portion of the catheter, such that the drain lumen and the flush lumen are in communication with each other through the at least one septum hole. The catheter wall has at least one wall hole located adjacent the distal end portion of the catheter so that the drain lumen communicates with the drain site when the distal end portion of the catheter is positioned within the drain site.

[0009] The volume of the drain lumen can be equal to the volume of the flush lumen. The volume of the drain lumen can be greater than the volume of the flush lumen. The at least one septum hole can include a plurality of septum holes. The at least one septum hole can include a distal hole having a first diameter and a proximal hole having a second diameter, the second diameter being different from the first diameter. The second diameter can be smaller than the first diameter. The at least one septum hole and the at least one wall hole can be offset.

[0010] The system can include a pressure sensor or a flow monitoring sensor coupled to the drain tube and the controller. The system can include a housing having a first pump, a second pump, and a controller disposed therein. The system can include an injection port coupled to the flush tube. The system can include a syringe connected to the injection port by a third tube, and / or the system can include a third pump coupled to the injection port by a third tube.

[0011] According to the disclosed subject matter, a catheter for percutaneous drainage of a drainage site is provided. The catheter can include a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter disposed within the drainage site, a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter, a drain lumen defined by the catheter wall and a first portion of the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter, and a flush lumen defined by a second portion of the catheter wall and the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter, the flush lumen being separated from the drain lumen by the septum. The septum can have at least one septum hole disposed therein adjacent to the distal end portion of the catheter, such that the drain lumen and the flush lumen are in communication via the at least one septum hole. The catheter wall has at least one wall aperture located adjacent the distal end portion of the catheter such that the drain lumen communicates with the drainage site when the distal end portion is positioned within the drainage site.

[0012] In accordance with the disclosed subject matter, a method for percutaneous drainage of a drainage site is provided. The method can include inserting a catheter into a drainage site, the catheter including a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter that is disposed within the drainage site; a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter; a drain lumen defined by the catheter wall and a first portion of the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter; and a flush lumen defined by the catheter wall and a second portion of the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter and separated from the drain lumen by the septum, wherein the septum has at least one septum hole disposed proximate the distal end portion of the catheter such that the drain lumen and the flush lumen are in communication via the at least one septum hole, and the catheter wall has at least one wall hole disposed proximate the distal end portion of the catheter such that the drain lumen is in communication with the drainage site when the distal end portion is disposed within the drainage site. The method may further include the steps of drawing fluid from the drainage site through the drain lumen, identifying an obstruction in the drain lumen, flowing irrigation fluid through the flush lumen and into the drain lumen through at least one septum hole to thereby remove the obstruction, and resuming drawing fluid from the drainage site through the drain lumen.

[0013] The method may include pausing the withdrawal of fluid from the drainage site through the drain lumen. The pausing may include reversing a direction of fluid flow in the drain lumen. The method may include monitoring a rate of withdrawal of fluid from the drainage site. The method may include resuming the withdrawal of fluid from the drainage site through the drain lumen. The method may include monitoring a rate of change of a rate of fluid withdrawal from the drainage site. Identifying an obstruction in the drain may be based at least in part on one or more of a rate of fluid withdrawal from the drain site and a rate of change of the rate of fluid withdrawal from the drain site. The method may include monitoring pressure in the drainage lumen. The method may include monitoring a rate of change of pressure in the drainage lumen. Identifying an obstruction in the drain lumen may be based at least in part on one or more of a pressure in the drain lumen and a rate of change of pressure in the drain lumen.

[0014] According to the disclosed subject matter, a system for percutaneous drainage of a drainage site can include a catheter, a drain tube, a first pump, a flush tube, a second pump, and a controller. The catheter can include a drain tube extending from a proximal end portion of the catheter. The catheter includes a catheter wall extending to a distal end portion of the catheter disposed within the catheter site; a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter; a drain lumen defined by the catheter wall and a first portion of the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter; and a flush lumen defined by a second portion of the catheter wall and the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter, separated from the drain lumen by the septum. The drain tube has a first end coupled to the drain lumen at the proximal end portion of the catheter and a second end coupled to a waste collection container. The first pump is coupled to the drain tube between the first end of the drain tube and the second end of the drain tube. The flush tube has a first end coupled to the flush lumen at the proximal end portion of the catheter and a second end coupled to a flush material container having a flush material disposed therein. The second pump is coupled to the flush tube between the first end of the flush tube and the second end of the flush tube. The controller is coupled to the first pump and the second pump for controlling the first pump and the second pump. The first portion of the catheter wall has at least a first wall hole disposed proximate the distal end portion of the catheter such that the drain lumen communicates with the drainage site when the distal end portion of the catheter is positioned within the drainage site. The second portion of the catheter wall has at least a second wall hole disposed proximate the distal end portion of the catheter such that the flush lumen communicates with the drainage site when the distal end portion of the catheter is positioned within the drainage site. [Brief explanation of the drawings]

[0015] This patent or application contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Patent and Trademark Office upon request and payment of the necessary fee. [Figure 1A]1 is a schematic diagram of an exemplary system for percutaneous drainage according to the disclosed subject matter (part 1). FIG. [Figure 1B] FIG. 2 is a schematic diagram of an exemplary system for percutaneous drainage according to the disclosed subject matter (part 2). [Figure 2] 1B is a cross-sectional view of an exemplary catheter for use with the system of FIG. 1A in accordance with the disclosed subject matter. [Figure 3A] 1A provides a cross-sectional view of an exemplary catheter for use with the system of FIG. 1A in accordance with the disclosed subject matter (part 1). [Figure 3B] 1B provides a cross-sectional view of an exemplary catheter for use with the system of FIG. 1A in accordance with the disclosed subject matter (part 2). [Figure 3C] 1B provides a cross-sectional view of an exemplary catheter for use with the system of FIG. 1A in accordance with the disclosed subject matter (part 3). [Figure 4] FIG. 1B is a perspective view of an exemplary housing for use with the system of FIG. 1A in accordance with the disclosed subject matter. [Figure 5A] 1B is a perspective view of an exemplary base and cover, respectively, along with certain elements for use with the system of FIG. 1A, in accordance with the disclosed subject matter; [Figure 5B] 2A-2C are perspective views of an exemplary base and cover, respectively, along with certain elements for use with the system of FIG. 1A in accordance with the disclosed subject matter. [Figure 6] FIG. 1B is a top cutaway view of an exemplary housing along with certain elements for use with the system of FIG. 1A in accordance with the disclosed subject matter. [Figure 7] FIG. 1B is a block diagram of certain elements for use with the system of FIG. 1A in accordance with the disclosed subject matter. [Figure 8] 1B provides multiple views of wearable components for use with the system of FIG. 1A in accordance with the disclosed subject matter. [Figure 9A] 1A provides an illustration of a graphical user interface for use with the system of FIG. 1A (part 1). [Figure 9B] 1A provides an illustration of a graphical user interface for use with the system of FIG. 1A (part 2). [Figure 9C] 1A provides an illustration of a graphical user interface for use with the system of FIG. 1A (part 3). [Figure 10] 1 is a schematic diagram of a portion of an exemplary system for percutaneous drainage including multiple drainage catheters in accordance with the disclosed subject matter. [Figure 11] 1 illustrates a control unit coupled to one or more modular pumps in accordance with the disclosed subject matter. [Figure 12] 1 is a plot of the results of suction through a drainage catheter over a 20 minute period in accordance with the disclosed subject matter using three different suction conditions. [Figure 13] FIG. 1 is a schematic diagram of an exemplary catheter in accordance with the disclosed subject matter used for computational fluid dynamics analysis. [Figure 14] 10 illustrates exemplary results of a computational fluid dynamics analysis of a catheter in accordance with the disclosed subject matter. [Figure 15] 10A-10C illustrate exemplary results of a computational fluid dynamics analysis catheter using various flushing methods in accordance with the disclosed subject matter. [Figure 16] 10 shows exemplary results of a computational fluid dynamics analysis of a catheter with variable septum hole locations in accordance with the disclosed subject matter. [Figure 17] 10 shows exemplary results of a computational fluid dynamics analysis of a catheter with variable septum hole diameters in accordance with the disclosed subject matter. [Figure 18] 10 illustrates exemplary results of a computational fluid dynamics analysis of a catheter with variable lumen volume ratio in accordance with the disclosed subject matter. [Figure 19] 10 shows exemplary results of a computational fluid dynamics analysis of catheters with and without external flush holes in accordance with the disclosed subject matter. [Figure 20] 10 shows exemplary results of a computational fluid dynamics analysis of a catheter with and without distal end holes in accordance with the disclosed subject matter. [Figure 21] 1 is a flow chart of a method for percutaneous drainage of a drainage site. [Figure 22] FIG. 1 is a schematic diagram of an exemplary system for enteral nutrition in accordance with the disclosed subject matter. DETAILED DESCRIPTION OF THE INVENTION

[0016] [Detailed explanation] Reference will now be made in detail to various exemplary embodiments of the disclosed subject matter, which are illustrated in the accompanying drawings. As used in this specification and the appended claims, the singular forms "a," "an," "the," and singular nouns are intended to include the plural forms as well, unless the context clearly dictates otherwise.

[0017] In general, and as described in more detail below, the disclosed subject matter provided herein includes systems and methods for percutaneous drainage. For example, a system for percutaneous drainage of a drainage site includes a catheter, a drain tube, a first pump, a flush tube, a second pump, and a controller. The catheter includes a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter, a distal end portion of the catheter configured to be positioned within the drainage site, a septum extending from the proximal end portion of the catheter to the distal end portion of the catheter and positioned within the catheter wall, a drain lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter, defined by the catheter wall and a first portion of the septum, and a flush lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter, defined by the catheter wall and a second portion of the septum, wherein the flush lumen is separated from the drain lumen by the septum. The catheter includes a drain tube having a first end coupled to the drain lumen at the proximal end portion of the catheter and a second end coupled to a waste collection container. The first pump is coupled to the drain tube between the first end of the drain tube and the second end of the drain tube. The flush tube has a first end coupled to the flush lumen at the proximal end portion of the catheter and a second end coupled to a flush material container having a flush material disposed therein. The second pump is coupled to the flush tube between the first end of the flush tube and the second end of the flush tube. A controller is coupled to the first pump and the second pump for controlling the first pump and the second pump. The septum has at least one septum hole disposed therein adjacent to the distal end portion of the catheter, such that the drain lumen and the flush lumen are in communication with each other through the at least one septum hole. The catheter wall has at least one wall aperture located adjacent the distal end portion of the catheter so that the drain lumen communicates with the drainage site when the distal end portion of the catheter is positioned within the drainage site.

[0018] Although the systems and methods are described herein with respect to specific percutaneous drainage procedures, such as abscess drainage, the systems and methods can be used for a wide variety of clinical applications common to the fields of interventional radiology and / or surgery. For example, the systems and methods described herein can be used for percutaneous thoracostomy (i.e., pleural drainage and / or pleurodesis of fluids and / or gases); percutaneous pericardiostomy (i.e., pericardial drainage); percutaneous nephrostomy, nephroureterostomy, and / or cystostomy (i.e., drainage and / or irrigation within the urinary tract); percutaneous cholecystostomy and biliary (internal and external) drainage; cystic lesions, recurrent fluid collections (e.g., lymph node and other lymphatic disorders), and other conditions. and / or percutaneous chemical resection and / or sclerosing of hollow viscus (such as the gallbladder in candidates deemed unsuitable for cholecystectomy); percutaneous esophagostomy, gastrostomy, gastrojejunostomy, jejunostomy, and / or cecostomy (i.e., gastrointestinal / gastrointestinal tract); percutaneous ventriculostomy and thecal sac drainage for hydrocephalus / CSF hypertension; and percutaneous thrombolysis / thrombectomy / embolectomy for thromboembolic disease of the arterial and / or venous vasculature.

[0019] As described in more detail below, the systems and methods described herein can rapidly drain unwanted fluids from the body at a faster rate using an electric pump system compared to standard drainage catheters, which typically rely on gravity or manual suction valves. The systems and methods can detect changes in catheter pressure dynamics and fluid volume movement via programmable sensors that indicate various system conditions, such as impending lumen occlusion, successful completion of drainage, and / or complications such as bleeding, pneumothorax, or fistula formation. The systems and methods can prevent and / or mitigate catheter occlusion via a self-cleansing, dual-lumen design using sterile saline and / or supplemental chemical / biological agents. The systems and methods described herein can include programmable suction / flush profiles tailored to the composition (e.g., volume, viscosity) of the fluid collection and can remotely monitor and control the performance of the drainage catheter system via wireless technology. This can allow healthcare providers and / or patients to adjust pump settings, such as suction and / or flush rate, volume, and / or frequency. Additionally, the systems and methods can collect and analyze biometric data (e.g., a patient's temperature, which can be indicative of sepsis). The collected data can be used to guide treatment decisions. The systems described herein can be housed in a self-contained, powered, wearable assembly with separate housings for the electronics (e.g., pump, circuit board, power supply), sterilization flush, and waste collection, with disposable components allowing for reuse.

[0020] 1A-3, which are disclosed for purposes of illustration and not limitation, a system 100 may be configured for percutaneous drainage. The system 100 may include a catheter 10, a drain (exhaust, suction, and / or drainage) tube 50, a flush (inflow) tube 51, a connector 52, a drain (exhaust, suction, and / or drainage) pump 30, a flush (inflow) pump 40, a controller 60, a waste collection container 70, and a flush material container 71. The flush material container 71 may include a flush material 72. The flush material 72 may be saline or another suitable flush material. For example, sterile (0.9%) saline may be used, which may or may not include one or more antimicrobial agents (e.g., antibiotics and antifungals) or therapeutic enzymes (e.g., tissue plasminogen activator [tPA], dornase, collagenase, and the like). The system 100 may include a remote device 67 in communication with the controller 60. The waste collection container 70 can have a predefined baseline vacuum / negative internal pressure.

[0021] As described in more detail below, catheter 10 can be placed at a drainage site 2 of a patient. System 100 can use a first lumen (e.g., drain lumen 15, described below) to remove fluid from drainage site 2. System 100 can maintain the patency of the first lumen by (1) using a second lumen (e.g., flush lumen 16, described below) to periodically deliver a local diluent and / or (2) reversing flow in the first lumen to remove occluded debris, or both (simultaneously or not).

[0022] The catheter 10 may include a catheter wall 11 extending from a proximal end portion 12 of the catheter 10 to a distal end portion 13 of the catheter 10. The distal end portion 13 of the catheter 10 may be configured to be disposed at a drainage site 2. The catheter 10 may be a dual-lumen catheter 10. For example, the catheter 10 may include a septum 14 disposed within the catheter wall 11 and extending from the proximal end portion 12 of the catheter 10 to the distal end portion 13 of the catheter 10. The catheter wall 11A and a first portion of the septum 14 may define a drain lumen 15 (also referred to as an outflow, suction, and / or drainage lumen), and the catheter wall 11B and a second portion of the septum may define a flush lumen 16 (also referred to as an inflow lumen). Each of the drain lumen 15 and the flush lumen 16 may extend from the proximal end portion 12 of the catheter 10 to the distal end portion 13 of the catheter 10. The volume ratio between the drain lumen 15 and the flush lumen 16 can be equal (i.e., 50-50; FIG. 3A) or unequal, e.g., 80-20, 70-30 (FIG. 3B), 60-40 (FIG. 3B), or any other suitable ratio to achieve the desired flow dynamics. While a specific dual-lumen catheter (i.e., two lumens separated by a septum) is described, any suitable dual-lumen catheter can be used. Examples include catheters with coaxial lumens, or catheters with a septum that is straight, curved, helical, or twisted along the length of the catheter's longitudinal axis, or catheters in which two parallel cylindrical or semi-cylindrical (or other shapes with flat edges) catheters are fused along their length, with the lumens either straight or twisted (intertwined) along the catheter's long axis. As another example, the drain lumen 15 or the flush lumen 16 can be integrated into the catheter wall 11. Additionally, the drain lumen 15, flush lumen 16, catheter wall 11, and septum 14 can have any suitable shape to achieve the desired flow dynamics.The material of construction of catheter 10 may be any suitable material that is biocompatible and amenable to thermoplastic extrusion, a common method for multi-lumen catheter construction. For example, the catheter 10 can be made of silicone, polyurethane, polyethylene, polyvinyl chloride, polytetrafluoroethylene, nylon, or a thermoresponsive polymer. The catheter wall can be non-braided and / or braided with thin filament materials.

[0023] The septum 14 may include at least one septum hole 17 (e.g., 17A-17F; also referred to as fenestrations) along its length, thereby providing a drain lumen. The drain lumen 15 and the flush lumen 16 communicate through septum holes 17. For example, by way of illustration and not limitation, as shown in FIG. 2, the septum 14 can include six septum holes 17. The septum holes 17 can be located proximate the distal end portion 13 of the catheter 10. The catheter wall 11 can include at least one wall hole 18 (e.g., 18A-18D) along its length such that the drain lumen 15 communicates with the drainage site 2 when the distal end portion 13 of the catheter 10 is positioned within the drainage site 2. For example, by way of illustration and not limitation, as shown in FIG. 2, the catheter wall 11 can include four wall holes 18. The wall holes 18 can be located proximate the distal end portion 13 of the catheter 10. Additionally or alternatively, the drain lumen may have an open distal end hole to provide further communication with the drainage site or to allow the catheter 10 to be delivered over a guidewire.

[0024] In an exemplary embodiment, the catheter 10 can include at least one wall hole 18 along its length in a second portion of the catheter wall 11B such that the flush lumen 16 communicates with the drainage site 2 when the distal end portion 13 of the catheter 10 is positioned within the drainage site 2. In such an embodiment, the septum 14 can include no septum hole 17 or one septum hole 17. Such a catheter 10 can also include a catheter 11B for injecting enzymatic and / or caustic agents, such as detergents, into the flush lumen 16. The drain lumen 15 can be used to deliver fluid to the injection site via a drain lumen 15, which can dissolve and / or otherwise degrade complex components of the fluid collection, as well as iatrogenically induce an inflammatory response within the cavity to promote scarring and healing. The drain lumen 15 can be used to collect and remove flushing material, as well as underlying pathological fluids.

[0025] Wall hole 18 can be formed by any suitable means, for example, punch, drill, or laser. Septum hole 17 can likewise be formed by any suitable means. If desired (e.g., if no hole is intended), an inert, durable insert can be used when forming septum hole 17 and / or wall hole 18 to prevent damage to the interior of catheter wall 11 or septum 14. Septum hole 1 7 can be offset from wall hole 18, for example, by delivering a puncture device at an angle to septum 14 through wall hole 18. For example, septum hole 17 can be formed using a puncture device that fits into wall hole 18. This can create septum hole 17 that can direct irrigation fluid back toward wall hole 18 (e.g., due to the relationship between septum holes 17A, 17B and wall hole 18A). Additionally, septum hole 17 can be drilled at an angle, thereby directing irrigation fluid back toward the corresponding wall hole 18 located just proximal to septum hole 17. Septum hole 17 and wall hole 18 can be positioned at any suitable location along septum 14 and catheter wall 11, respectively, and can be any suitable size or shape to provide desired flow dynamics, as described in more detail below. The size of wall hole 18 and septum hole 17 can vary along the length of catheter 10. For example, the more distal septum holes 17 (e.g., 17A, 17B) may be larger than the more proximal septum holes 17 (e.g., 17E, 17F). This allows for approximately equal flow through the septum holes 17 along the length of the catheter. Alternatively, it may be desirable to provide a higher rate of fluid flow through a particular septum hole. A higher flow rate through a particular septum hole may affect the patency of the corresponding or adjacent wall holes. For example, the septum holes 17 may have progressively larger diameters as fluid flows through the flush lumen 16 from the proximal end portion 12 of the catheter 10 to the distal end portion 13 of the catheter. Alternatively, the distal septum holes 17 (e.g., 17A, 17B) may have a smaller diameter than the proximal septum holes 17 (e.g., 17E, 17F). While described with respect to specific examples, any suitable septum holes 17 may be used to create communication between the flush lumen 16 and the drain lumen 15, and any suitable wall holes 18 may be used to create communication between the drain lumen 15 and the drainage site 2. Additionally, it may be desirable to achieve greater flow rates in the wall holes 18A and 18B toward the distal end portion 13 of the catheter 10, as the wall holes toward the distal end portion 13 are more prone to clogging during use. While specific septum holes 17 and wall holes 18 are described, any suitable septum holes 17 and wall holes 18 can be used to achieve the desired flow dynamics. For example, holes of various sizes, size gradients along the length, and various shapes (e.g., oval, slit, polygonal, circular) can be used. The walls of the holes can be straight, tapered, rounded, or curved. The holes may be staggered or aligned along any aspect of the catheter (e.g., spiral). Exemplary arrangements of septum holes 17 and wall holes 18 are provided in more detail below.

[0026] The distal end portion of the flush lumen 16 may be closed. For example, a distal plug 19 or other suitable means for closing the distal end of the flush lumen 16 may be provided. The distal plug 19 may prevent irrigation solution (e.g., sterilization solution) from exiting the distal tip of the catheter 10, instead forcing the irrigation solution through the septum hole 17 and into the drain lumen 15. This may increase pressure within the drain lumen 15, dislodging material blocking the drain lumen 15 or wall hole 18. The irrigation solution may also dilute more viscous bodily fluids to facilitate drainage of the drainage site 2. The distal plug 19 and / or the distal end of the catheter 10 may be rounded to facilitate insertion through tissue into the drainage site 2. While a particular system for closing the distal end portion of the flush lumen 16 is described, any suitable means for closing the distal end portion of the flush lumen 16 may be used. The distal end portion of the drain lumen 15 can be open, thereby allowing further communication with the drainage site 2, and / or the distal end portion of the drain lumen 15 can be used for routing using a guidewire, for example, for over-the-wire catheter insertion using the Seldinger technique.

[0027] The catheter 10 can have a straight, pigtail, looped, or other curved configuration. One or more configuration / curvature combinations may be included in series, or one or more configurations / curvatures may be cycled. The catheter 10 may be deformable to allow placement in a first configuration and then transition to a second configuration. For example, a shape memory material may be used to transition the catheter 10 to the second state and hold the catheter 10 in place.

[0028] In accordance with the disclosed subject matter, the catheter 10 can include a size taper from a larger proximal portion 12 to a smaller distal portion 13, such that the catheter body can completely occlude the subcutaneous tunnel tract when the distal portion 13 is disengaged from the drainage site 2. The tapered outer diameter can also prevent leakage around the catheter. Additionally, or alternatively, the catheter 10 can include a short length of ribs and / or grooved threads on the outer wall 11 along its proximal mid-segment, which can allow the catheter to be secured with a securement device, such as a non-absorbable suture. Alternatively, an inflatable balloon, mushroom-shaped silicone dome, serrated ring, or deployable T-tack can be slid down the length of the catheter to the level of the skin opening, anchoring the catheter 10 in the subcutaneous soft tissue.

[0029] 1B, system 100A may include each of the features of system 100 and may further include a syringe injection port 53 coupled to flush tube 51 and third tube 54. Third tube 54 may be connected to syringe 55 (or a third pump and reservoir). Syringe 55 may be used to deliver a sclerosing agent, drug, or other additional substance into flush tube 51.

[0030] For purposes of illustration and not limitation, and referring to FIGS. 4-6 , the system 100 can include a housing 80. The housing can be, for example, an enclosure for housing some or all of the electronic components of the system 100. For example, the housing 80 can house the drain pump 30, the flush pump 40, and the controller 60. The housing 80 can include a base 81 and a cover 82. The base 81 and / or the cover 82 can include mounting mechanisms 83 (e.g., 83A, 83B) for supporting various electronic components. The mounting mechanism 83 can be, for example, an M3 heat-set insert that can be configured to receive an M3×10 mm socket head cap screw (SHCS). While a specific mounting mechanism is described, any suitable mounting mechanism 83, such as a screw, nail, or adhesive, can be used. The cover 82 can be secured to the base 81 by any suitable means, for example, an M3×10 mm SHCS. When secured together, the base 81 and the cover 82 can form a protective and insulating housing 80 for the electronic components. Housing 80 may be sized and shaped so that housing 80 can be retained within, for example, a wearable pack (described in more detail below).

[0031] The drain pump 30 and the flush pump 40 can be any suitable pumps, for example, 6V peristaltic pumps, and can be mounted within the housing 80. Similarly, the controller 60 can include any necessary or appropriate 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 Bluetooth® Low Energy (BLE) transmitter). While specific components are described for the drain pump 30, the flush pump 40, and the controller 60, any suitable components can be used. The housing 80 can also accommodate a breadboard 65, for example, on the lid 82. The breadboard 65 can be used to route battery power from the battery 63 to the microcontroller 61 and the motor driver 62 and can allow for modular, expandable off-board circuitry to be added as needed. The housing 80 may also include a pressure sensor 66 attached to the drain tube 50 via a T-junction connector 84. The housing 80 may include load transducers or liquid level sensors in the flush material container 71 and waste collection container 70 to measure fluid volume and drained fluid flow. The pressure sensor 66 may include a diaphragm seal and may utilize a MEMS sensor.

[0032] The base 81 and cover 82 may each have slots 85, 86 (respectively) that may correspond to the location of the drain pump 30 and the flush pump 40, allowing the drain tube 50 and the flush tube 51 to be inserted into the respective drain pump 30 and flush pump 40. The drain tube 50 and flush tube 51 may pass through both the base 81 and the cover 82 to connect with the flush pump 40. For example, the drain tube 50 may extend from the waste collection container 70 through a slot 86 in the cover 82 to be routed to connect with the drain pump 30, then via a T-junction connector 84, through a slot 85 in the base 81, and then via a connector 52 to couple to the drain lumen 15 at the proximal end portion 12 of the catheter 10. The flush tube 51 may extend from the flush material container 71 through a slot 85 in the cover 82 to be routed to connect with the flush pump 40, through a slot 85 in the base 81, and then via a connector 52 to couple to the flush lumen 16 at the proximal end portion 12 of the catheter 10.

[0033] For purposes of illustration and not limitation, and with reference to FIG. 7 , a battery 63 can provide power to one or more elements disposed within a housing 80. The battery 63 can be removable from the housing, for example, for recharging or replacement. The battery 63 can be connected to a breadboard 65. A switch 69 can be provided between the battery 63 and the breadboard 65 to turn the device on and off. Power can be distributed at the breadboard 65 to a transmitter 64, a microcontroller 61, and a motor driver 62.

[0034] The microcontroller 61 can be used to provide logic for the transmitter 64, motor driver 62, drain pump 30, flush pump 40, and pressure sensor 66. For example, the microcontroller 61 can be an Arduino Uno board and can be programmed in C++ in the Arduino Integrated Development Environment (IDE). The microcontroller 61 can be connected to the pressure sensor 66 to receive pressure measurements from the drain tube 50. The microcontroller 61 can be connected to the transmitter 64 to send and receive information (e.g., receive operating instructions and transmit pressure or other measurements) to and from a remote device 67, such as a computer (e.g., a laptop or desktop computer), a personal data or personal digital assistant (PDA), or other user equipment such as a mobile phone or portable media player or tablet. Communication between the transmitter 64 and the remote device 67 can be via wires or one or more of a network, radio frequency, or wireless connection such as Bluetooth®. The microcontroller 61 can also be connected to a motor driver 62, which can be connected to each of the drain pump 30 and the flush pump 40. Thus, the microcontroller can send control signals (e.g., in the form of digital signals) to the motor driver 62, which can send signals, such as pulse or step signals and direction signals (e.g., in the form of pump voltages), to the drain pump 30 and the flush pump 40. Although specific arrangements are described, any suitable arrangement can be used for the electronic components to achieve the desired draining and cleaning.

[0035] By way of example and not limitation, and referring to FIG. 8 , the housing 80 can be sized to fit within a wearable component 90, such as a belt-mounted pouch 91. The belt 92 can be adjustable, allowing the patient to carry the system 100 relatively easily. The pouch 91 can be designed to fit the housing 80 and can include holes or slots to allow the flush tube 51 and the drainage tube 50 to extend through the pouch 91. Two external containers 93, 94 are available in a variety of sizes that can be attached directly to a belt via a holster or to built-in pockets within the pouch 91. The external containers 93, 94 can hold the flush material container 71 and the waste collection container 70, respectively. Although a wearable component is described, any suitable wearable component may be used.

[0036] In normal operation, the catheter 10 can be delivered to the drainage site 2. Commands are provided from the microcontroller 61 to the motor driver 62 to operate the drain pump 30, which, in conjunction with the drain tube 50, can draw fluid from the drainage site through the wall aperture 18, the drain lumen 15, the drain tube 50, and into a waste collection container 70 (also referred to as a drain line). One-way (e.g., duckbill) valves can be used within various elements and / or junctions of the drain line to prevent backflow and / or leakage of waste fluid. During drainage, the pressure sensor 66 can continuously (or intermittently) measure the pressure within the drain tube 50 and continuously supply a voltage to the microcontroller 61. For example, an average value across a buffer can be obtained, such as 10 pressure sensor measurements at approximately 1000 Hz. If a clog forms within the drain pathway (i.e., within the wall aperture 18, the drain lumen 15, or the drain tube 50), the average pressure value can rise above a threshold value. The threshold value can be, for example, a user-defined threshold value. The system 100 can recognize that a flush operation can be initiated if the average pressure increases, indicating a clog. For example, the microcontroller 61 can send a signal via the motor driver 62 to stop the drain pump 30. The microcontroller 61 can also send a signal via the motor driver 62 to start or ramp up the flush pump 40 to pump flush solution from the flush material container 71, through the flush tube 51, through the flush lumen 16, and through the septum hole 17 (also referred to as the flush line). Additionally or alternatively, the microcontroller 61 can also send a signal via the motor driver 62 to reverse the flow of the drain pump 30. These actions can flush out clogs that may have formed in the septum hole 18, the drain lumen 15, and / or the drain tube 50. The microcontroller 61 can control the rate of backflow in the drain line, for example, by programming the flush volume to be equal to the length of the drain lumen 15 and the drain tube 50.This prevents any existing waste material in the waste collection container 70 from being reintroduced into the body. After the flush operation is performed, the microcontroller 61 sends a signal via the motor driver 62 to stop the operation of the flush pump 40 and restart the operation of the drain pump 30 to resume the drain process. A separate measurement buffer can be used to prevent multiple flushes in a short period of time while the pressure reading is stable. In the system 100a of FIG. 1B, the microcontroller 61 can further control the syringe 55 (or a third pump) to add a solution (e.g., a sclerosing agent / drug) into the flush tube 51 and deliver it into the flush line.

[0037] The remote device 67 can communicate with the transmitter 64 via wireless transmission, such as a Bluetooth® connection. For example, the Adafruit Bluefruit library can be used. Android Studio can be used to develop a companion application in Java® (e.g., for use with the Android® operating system). The application can enable Bluetooth® connectivity to the microcontroller 65 (via the transmitter 64), allowing different device settings optimized for the patient's condition or medical condition settings to be selected and customized by the user (e.g., clinician) in the application. For example, pump speed, flush frequency, and flush volume can be adjusted using the application. Preset device configurations and settings for different medical conditions, tube diameters, and catheter sizes can be specified in the application to improve ease of use and specificity. Additionally, a schedule can be used to detect and update blockages. The application can be programmed by the user to control the flush frequency, allowing the catheter 10 to be flushed periodically without requiring a clog to be detected. The application also provides access to manual pumping operations, such as flushing the system or reversing flow, when selected in the application, rather than requiring a clog to be detected. The application can be controlled via a graphical user interface 68 (FIGS. 9A-9C) or, alternatively, using physical controls (e.g., a touchscreen) integrated with the hardware.

[0038] Statistics and information can be collected and stored within the controller 60. For example, biometrics and fluid drainage statistics (e.g., abscess volume drained, pressure generated during suction) can be collected and stored. Fluid drainage statistics can be used to notify the user via an application when the waste collection container or flushing material container is full or empty and needs to be replaced, respectively. The controller 60 can be reset before each use. Algorithms can be run on the microcontroller 65, such as regression equations to calculate how much abscess volume has been drained using pump speed and duration. The information can then be transferred to a remote device 67 (e.g., via Bluetooth, Wi-Fi, a cellular network, or radio frequency) and accessed by the user. The information can then be used for further diagnosis, and additional and / or new instructions can be provided via the remote device 67. For example, a gradual and consistent decrease in pressure change indicates that the abscess has collapsed or is healing, while a sudden increase in pressure change may indicate that an obstruction (e.g., a fistula) has formed or the catheter is malfunctioning. Thus, an alert can be provided to a healthcare provider.

[0039] Additionally or alternatively, additional programmable features can be provided. For example, simultaneous pumping in real time, alternating pumping, reversing pump function, changing high / low pressure settings, and sensor thresholds can be customized to customize pump operation and settings. Suction / flush settings can be configured to automatically adjust / adapt mechanical properties for drainage, obstructed lumen debris, and translated pressure within the drainage site 2. For example, the system can automatically detect air (pneumothorax), thin serous fluid (e.g., serous fluid), and other fluids. fluids of medium viscosity (e.g., pus from abscess / empyema, non-sensible fluids), stained bile, infected urine), and highly viscous fluids (e.g., infected bile, liquefied hematoma, superinfected necrotic Depending on the fluid being drained (including tissue, pancreatic pseudocysts, ruptured bowel contents), different actions can be taken. For example, a sterile saline irrigation with applied pressure pulses can be used to flush complex collections and liquefy their contents.

[0040] Additionally or alternatively, an integrated set of patient biometric sensors (e.g., temperature, heart rate, blood pressure, glucose level, hydration status, or other biometric information) may be provided and further influence the system's functionality. Real-time data can be transmitted to a HIPAA-secure website (in addition to or instead of the remote device 67) for healthcare providers to monitor and provide change notifications for significant changes in health status. For example, the rate of change of fluid flow rate, total aspirated fluid volume / time, and pressure in the catheter 10 and / or the body cavity can be monitored and communicated. A slow, gradual decrease in daily fluid output may indicate a patient's medical outcome, such as resolution of an abscess, resolution of a pneumothorax without further air leaks allowing for chest tube removal, patency of the cystic duct allowing for cholecystostomy tube removal, or patency of the ureter allowing for PCN / PCNU removal. A rapid increase in intracavitary pressure and resistance to flow may indicate bleeding. A rapid decrease in body cavity pressure may indicate fistula formation. Biofeedback data can be used in conjunction with artificial intelligence and machine learning techniques to identify specific types of fluid collection, anticipated resolution of drainage, and and the patient's health risk level. Although specific examples of data and methods for storing, transmitting, and using that data are described, any suitable data may be measured, stored, transmitted, or relied upon.

[0041] According to the disclosed subject matter, a pre-filled cartridge containing chemical / enzymatic agents can be provided that can be injected into the flush line to dissolve debris and / or antibacterial agents within the lumen. For example, one or more of tissue plasminogen activator (tPA), donase, collagenase, a sterile weak acid solution, or an antibacterial / antimycotic agent can be provided. Additionally or alternatively, catheter vibration via a high-frequency oscillator attached to the catheter 10, embedded piezoelectric crystals for sonication, and / or other mechanisms can be used to maintain lumen patency. An integrated bioagent assay can be provided to determine the specific chemical composition of the effluent being removed.

[0042] Multiplexed systems with one or more catheters and / or one or more pumps

[0043] In accordance with the disclosed subject matter, multiple catheters 10 can be provided to a single patient, with one or more control systems (e.g., a single CPU) managing each catheter 10. For example, a patient can receive multiple drainage catheters, with a single central receiver managing and / or coordinating the variable functions of each drainage catheter 10 (e.g., monitoring for blockages, determining when to flush, monitoring patient status). Additionally, systems can be modularly stacked, with one system dedicated to each fluid collection, which can minimize ergonomic strain on the patient and facilitate management.

[0044] Referring to FIG. 10 , an individual patient with multiple separate abscesses 200A, 200B or a single multilocular abscess may require the insertion of multiple drainage catheters 10A, 10B for adequate fluid drainage. When a system is used to treat multiple separate abscesses or a single multilocular abscess, the system may be multiplexed to either simultaneously suction and irrigate multiple catheters or alternate drainage by switching between catheters. This multiplexing capability allows a single system, via its controller logic, to automatically control multiple drainage and / or feeding catheters in an individual patient or to modularly add more pumps to the system. For example, valve 103, shown as a three-way stopcock between catheters 10A and 10B, can alternate drainage between two or more catheters draining multiple abscesses or a single complex abscess. Valve 103 can be switched between a first state and a second state. 10 , fluid is communicated from the first abscess 200A through the valve 103 to the waste collection container 70. In the first state, waste material can be removed from the first abscess 200A, but not from the second abscess 200B. In a second state (not shown), fluid is communicated from the second abscess 200B through the valve 103 to the waste collection container 70. In the second state, waste material can be removed from the second abscess 200B, but not from the first abscess 200A. Additionally or alternatively, the valve 103 is automatically operated by the controller 60.

[0045] In accordance with the disclosed subject matter, multiple pumps and / or valves may be coordinated by a central control unit. For example, multiple drain and flush pumps may be multiplexed to allow either simultaneous aspiration and irrigation of multiple catheters or alternate drainage switching between catheters. Alternatively or additionally, the control of the central control unit may be A central control unit coordinates the operation of multiple pumps and / or valves.

[0046] With respect to multiple pumps, multiple pumps can be plugged into a central control unit, which can then power and individually control each modular pump. Referring to FIG. 11, the central control unit 101 serves as a hub that provides power and coordinates the operation of each individual pump (102a, 102b, 102c, 102d). Each individual pump can be identified by assigning a unique numerical value, ensuring that each pump is accurately programmed accordingly and that the correct line (functioning as suction or flush) is secured to that specific individual pump. Each individual pump can be attached to either the waste collection container 70 or the flush material container 71, depending on its role. The central control unit 101 allows each individual pump to be independently programmed. Each individual pump (e.g., 102a, 102b) can be plugged into the central control unit 101 to receive power and communication via a direct connection. Additionally, individual pumps (e.g., 102c, 102d) can be plugged into pump 102a or 102b to receive power and communications through another pump. Additional pumps can be added in accordance with the disclosed subject matter. For example, if two additional drainage catheters are added, up to four individual pumps can be added to the system.

[0047] With respect to multiple valves, additional valves can be positioned between the pump and the catheters. These multiple valves can be adjusted by the control unit 101, and the multiple valves can be switched between two or more different states to service two or more separate catheters. Depending on the valve's position, fluid can be allowed or blocked from flowing through the valve, thus enabling alternate application of suction or flushing to individual catheters. By way of example and not limitation, and referring again to FIG. 10 , when suction generated by the peristaltic pump 102 is used to drain the first abscess 200A, the valve 103 can switch between two states as directed by the control unit 101. For example, the switching valve 103 can switch between the first catheter 10A and the second catheter 10B, which are positioned within the first and second abscesses 200A and 200B, respectively. Alternatively or additionally, the peristaltic pump 102 can alternate between periodic flushing and pumping, or can flush on demand if a clogged condition is detected in the line.

[0048] [Experimental Results: Effect of Periodic Flushing on Suction Performance]

[0049] In accordance with the disclosed subject matter, the drainage performance of the system disclosed herein using three different suction conditions was compared. A catheter 10 was used, having a flush lumen 16, a drain lumen 15, and a septum hole 17 for irrigating external drainage holes (e.g., 18A-18D) across the septum 14. Flushing across the septum 14 can remove debris blocking at least one external drainage hole 18A-18D and locally dilute abscess material to maintain lumen patency of the catheter 10. Catheters embodied herein were tested using three different suction conditions: (1) suction provided by a uresil accordion suction valve; (2) suction only from a peristaltic pump; and (3) suction with periodic flushing from a peristaltic pump. An abscess simulant consisting of fruit blended with dairy products was used. In condition (3), when irrigation was performed in addition to suction, 10 mL of water was irrigated through the catheter by a second peristaltic pump for 18 seconds every 2 minutes. Furthermore, the disclosed catheter was tested using water under three different suction conditions as a control. All three suction conditions expelled 100 mL (100 g) of water within 5 minutes (data not shown).

[0050] Referring to Figure 12, the results of 20 minutes of aspiration through a drainage catheter as disclosed herein using three different aspiration conditions are shown. After 20 minutes of draining an abscess analog using a catheter as disclosed herein, the uresil accordion valve 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 removed approximately 15 times more abscess material in the first 20 minutes than the accordion valve. Periodic flushing resulted in a 33% improvement over the same time frame using the same aspiration regimen. When uresil accordion valve suction and peristaltic suction were used alone (i.e., without flushing), rapid occlusion of the four drainage holes was observed within this time frame, and subsequent priming of the accordion valve (data not shown) had little or no effect. If suction force remains insufficient to pull material through the four 2-mm diameter drainage holes, the catheter will remain occluded, and drainage will cease or be significantly reduced unless removed by flushing.

[0051] Further, referring to FIG. 12, the standard error is shown in the shaded area, and the average mass expelled is shown for each of the three suction conditions. Periodic flushing can clear obstructions from the external drainage hole while locally diluting viscous material. In current medical practice, flushing is performed manually infrequently (e.g., once every 8 hours). Increasing manual flushing is not practical in clinical settings. However, as demonstrated herein, automated periodic flushing of the external drainage hole using a multi-lumen catheter with a septum hole can improve drainage at comparable suction pressures.

[0052] [Computational Fluid Dynamics (CFD) Analysis and Results: Catheter Structural Evaluation]

[0053] According to the disclosed subject matter, computational fluid dynamics (CFD) analysis of the disclosed catheter was used to evaluate different catheter configurations without the need for physical prototypes. CFD can determine parameters that evenly distribute the flush flow profile throughout the external drainage pore. Because blockages can occur irregularly across the catheter's external drainage or septum pores, it is important to flush uniformly throughout the entire length of the catheter to minimize the possibility of blockages leading to catheter failure.

[0054] For example, through iterative simulation prototyping, different catheters were rapidly modeled and evaluated for flushing performance, as measured by flow rate through the catheter's external drainage and septum holes. All 3D models of the dual-lumen catheters were created using 3D parametric modeling software, Fusion 360 (Autodesk, San Rafael, CA, United States). Using geometric modifiers, the catheter's structural features were parametrically manipulated to generate catheter structure concepts. Referring to Figure 13, the original reference catheter structure (Concept A) consisted of a dual-lumen channel with four external drainage wall holes 18a-18d (2 mm diameter) spaced 13 mm apart and four septum holes 17a-17d (1 mm diameter) aligned with equal spacing to the wall holes 18a-18d. The distal tip of the catheter 10 can be tapered and has a small opening to mimic the guide holes commonly found in multipurpose drainage catheters. The distal opening 21 may be in direct communication with the drainage lumen 15 and indirect communication with the flush lumen 16. In the CFD analysis, fluid flow through the distal opening 21 was ignored since its size and location only slightly affected the fluid dynamics.

[0055] Referring again to FIG. 1A, the catheter 10 has both a flush lumen and a drainage lumen. The catheter has two reversible pumps attached to it, which can be controlled independently. A typical flushing operation, combined with a short reversal of the aspiration pump at the same fluid rate, generates a larger positive flow, and therefore pressure, at the wall holes 18a–18d to remove debris. In Figure 15, the structure of the Reference Catheter Concept A was used to compare various flushing and / or aspiration pumping techniques. CFD was used to quantify the differences between saline flushing alone and simultaneous saline flushing and aspiration pump reversal. In addition, simultaneous flushing and aspiration pump reversal were compared to a saline flush-only technique with twice the flushing rate. The average flow rate at the wall holes 18a–18d was measured when the flushing fluid flow was split across both the drainage lumen 15 and the flush lumen 16, or when it was only the flush lumen 16. Simultaneous operation of both the flush and aspiration pumps was used to analyze all structural modifications.

[0056] Subsequent structural modifications to the catheter geometry were used to improve flushing performance. These structural modifications included septum hole alignment to the distal hole, changes in septum hole diameter, and cross-sectional areas of the drainage and flush lumens. All concepts were compared to a baseline catheter design (Concept A) to evaluate the increase / decrease in septum flow velocity during flushing. Table 1 summarizes the various catheter designs tested.

[0057] In Concepts B and C, the location of septum holes 17a-17d was staggered relative to wall holes 18a-18d along the catheter. It was theorized that fluid interference at the junction between flushing fluid and backflow from the drainage lumen could be compensated for by alternative positioning, improving flow through the wall holes. In Concepts D and E, the diameter of septum holes 17a-17d was varied such that the diameter of the septum hole increased from septum hole 17d near the proximal end portion 12 to septum hole 17a near the distal end portion 13. Additionally, in Concepts F and G, the volume ratio of the flush lumen to the drainage lumen was increased to investigate whether an increased Venturi effect could improve flushing. The structures of catheter Concepts A-G are shown in Table 1.

[0058] [Table 1] Table 1 - Summary of structural changes relative to the reference catheter (Concept A). Catheters The CFD analysis carried out for Concepts B to G simulated changes in volume ratio, bulkhead hole diameter, and bulkhead hole location.

[0059] [CFD Methods and Procedures]

[0060] To conduct CFD analysis, 3D CAD models of the proposed catheter designs were imported into OpenFOAM CFD software (The OpenFOAM Foundation, United Kingdom). Finite element models were generated in OpenFOAM at a scale of approximately 5:1 for catheter concepts A through G. Scaling models is a common approach to reducing simulation complexity and shortening the time to complete CFD simulations. Fluid dynamics during the device's flushing phase were visualized and quantified across all catheter design concepts. Simple steady-state fluid simulations were performed in OpenFOAM across catheter concepts A through G. Figure 14 shows the streamlines obtained by applying the finite volume method to solve the basic Navier-Stokes equations. Because no heat transfer was assumed in these simulations, only the equations for conservation of mass and momentum were applied. Uniform liquid properties of water were used at both inlets, assuming incompressible liquid flow. The flush flow inlet velocity was defined at 1.5 cm / s for the flush flow. When investigating the reversal of the flush and suction pumps, a flush flow inlet velocity of 1.5 cm / s was replicated at the drainage lumen inlet. Catheter performance between design concepts was evaluated by measuring the steady-state fluid velocity at the outlet during flushing. Specifically, the average fluid flow velocity across the surface area of ​​the external drainage wall holes 18a-18d was calculated.

[0061] [Iterative CFD Comparative Analysis: Saline Flushing Simulation]

[0062] Figure 15 and corresponding Table 2 show that in the saline flush simulation, there was a substantial increase in velocity for all pores (18a-18d) when simultaneously flushing and reversing the suction pump compared to flushing alone. Fluid flow increased by 147%, 102%, 79%, and 82% for pores 18d, 18c, 18b, and 18a, respectively. Reversing the flush and suction pump closely approximated the flow rate observed during saline flushing at twice the initial fluid rate. The decrease between these two conditions was less than 16% across all pores. Therefore, all subsequent CFD design evaluations will use only the saline flush and drainage flow removal mechanism. Table 2 shows the results from the reference catheter (Concept A) used for the three tests in Figure 15. For Table 2, the reference catheter was analyzed using saline flushing alone, saline flushing and simultaneous suctioning in the drainage lumen (i.e., fluid flow reversal), and saline flushing alone at twice the rate.

[0063] Table 2 - CFD results of the saline flush and / or simultaneous pump simulation of the reference catheter (Concept A). [Table 2]

[0064] [Iterative CFD Comparative Analysis: Bulkhead Hole Shift (Concepts B and C)]

[0065] In Figure 16 and corresponding Table 3, catheter performance was evaluated by shifting the septum holes 17a-17d toward the proximal end portion 12. For catheter concept B, shifting the septum holes 17a-17d 1.0 mm toward the proximal end portion 12 increased fluid velocity at all outlet wall holes 18a-18d compared to baseline catheter concept A. For catheter concept C, shifting the septum holes 17a-17d 6.5 mm toward the proximal end portion 12 increased fluid velocity at the most proximal wall holes 18d and 18c but decreased fluid velocity at the most distal wall holes 18b and 18a. In Table 3, the change in fluid velocity across outlet wall holes 18d, 18c, 18b, and 18a was +43%, +17%, -2%, and -13%, respectively. The greatest increase in fluid velocity for concept B was observed at outlet wall hole 18d, with a 15% increase.

[0066] [Table 3] Table 3 - Flow velocity in wall holes of Concept Catheter Configurations B and C compared to Reference Catheter (Concept A). : Change in fluid velocity in wall holes 18a-18d as a function of shifting the septum holes (e.g., 17a-17d, Figure 13) toward the proximal end portion 12 compared to Reference Catheter Concept A.

[0067] [Iterative CFD Comparative Analysis: Changing the Diameter of the Bulkhead Hole (Concepts D and E)]

[0068] In Figure 17 and corresponding Table 4, Concepts D and E were evaluated for CFD results by varying the diameter of septum holes 17a-17d. For Catheter Concept D, the septum hole diameters of septum holes 17d, 17c, 17b, and 17a were changed from 1 mm for all septum holes in the reference catheter to 1 mm, 1.5 mm, 2 mm, and 3 mm, respectively. Compared to Reference Catheter Concept A, the fluid velocity at the most proximal wall holes 18d and 18c in Catheter Concept D increased, while the fluid velocity at the most distal wall holes 18b and 18a decreased. For Catheter Concept E, the septum hole diameters of septum holes 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 most proximal wall holes 18d (41%) and 18c (16%), while a substantial increase in fluid velocity was observed at wall hole 18a (37%). As discussed above, wall holes 18 can become clogged during drainage. Wall holes 18 toward the distal end portion 13 of the catheter are more susceptible to clogging than wall holes 18 toward the proximal end portion 12 of the catheter. Therefore, the septum hole diameter can be specified to increase fluid velocity toward the distal end portion 13 of the catheter. The increased fluid velocity at septum hole 17 and / or wall hole 18 can help clear clogged material and maintain catheter patency.

[0069] [Table 4] Table 4 - Concept catheter designs D and E with varying septum hole size. Comparison of septum hole flow rates in Concepts D and E with a reference catheter (Concept A) with the same septum hole size.

[0070] Iterative CFD Comparative Analysis: Varying Drain and Flush Volume Characteristics (Concepts F and G)

[0071] In Figure 18 and corresponding Table 5, a comparative CFD analysis was performed for catheter Concepts F and G with different volumetric ratios between the drain lumen 15 (i.e., drain lumen) and the flush lumen 16. The 60:40 drain-to-flush ratio (Concept F) resulted in minimal differences in fluid velocity across all pores. Only pore 18b varied by 0.01 cm / s. However, the 80:20 drain-to-flush ratio (Concept G) showed a greater effect on pore fluid velocity. Compared to the reference catheter, pores 18d and 18c in Concept G decreased by 21% and 7%, respectively, while pores 18b and 18a increased by 2% and 13%, respectively.

[0072] [Table 5] Table 5 - Flow rates through septum holes in Concept catheter configurations F and G compared to a reference catheter (Concept A) with a 50:50 drain lumen to flush lumen ratio: Change in septum hole diameter in Concepts F-G compared to reference catheter Concept A with identically sized drain and flush lumens.

[0073] [Iterative CFD comparison analysis: Adding an outer flash hole (Concept H) reduces wall hole velocity]

[0074] With reference to FIG. 19 and corresponding Table 6, a comparative CFD analysis of catheter concept H, including both septum holes 17a-17d and outer flush holes 22a-22d, was performed using flushing only. It was hypothesized that the inclusion of outer flush holes 22a-22d would allow for more direct irrigation of the abscess cavity. However, the outward flushing CFD analysis of Concept H with holes 22a-22d demonstrated a substantial reduction in flush flow velocity across the wall holes 18a-18d. In particular, there was a greater than 40% reduction in fluid flow velocity at the wall holes 18a-18d in Concept H when compared to Concept A with bulkhead flush holes (but no outer flush holes 22a-22d). Thus, the inclusion of inward and outward flush holes results in lower fluid velocities through the wall holes 18a-18d, increasing the likelihood of debris blocking the drainage wall holes 18a-18d.

[0075] [Table 6] Table 6 - Comparison of Concept Catheter Structure H with External Flush Holes to Reference Catheter (Concept A): The addition of external flush holes 22a-22d reduced fluid flow in the drainage wall holes 18a-18d.

[0076] In Figure 20 and corresponding Table 7, a CFD comparison analysis was performed for Catheter Concept I, which includes distal end holes. Fluid flow from the distal end holes was assumed to be negligible. The CFD analysis of Concept I with distal end holes found that in the comparison between the reference catheter Concept A and Concept I with distal end holes, the fluid velocity across wall holes 18a-18d decreased proportionally, but was minimal. Therefore, the effect of the distal end holes on fluid velocity across the wall holes and the corresponding CFD analysis can be considered negligible.

[0077] [Table 7] Table 7 - Conceptual Catheter Configuration with Distal Holes I has negligible effect on the flow rate of the wall hole.

[0078] [Consideration of CFD results]

[0079] Using both parametric CAD modeling and CFD software, catheter design concepts can be rapidly analyzed and iterated using physics-based simulation. Various concepts can be tested and CFD results compared, with the goal of maximizing fluid velocity uniformly across all wall holes 18a-18d.

[0080] This structural change, including a short suction pump reversal during the flushing operation, resulted in a significant increase in fluid velocity across all pores compared to the flushing-only operation. Pit 18d showed the largest velocity increase (147%), while the other pore fluid velocities were This was nearly doubled compared to the flush-only condition. Simultaneous flushing with the suction pump reversed minimized the loss of fluid velocity (less than 17%) due to fluid interference at the lumen junction and could be nearly as effective as a virtual saline flush at twice the initial velocity. Therefore, this concept could be adopted as the final design and applied to all robust CFD simulations.

[0081] Many catheter internal structural modifications have been observed to improve overall fluid flow, but only when the parameters are carefully tailored. Suboptimal designs, such as shifting the septum 6.5 mm proximally or increasing the diameter of the septum pores from 0.5 to 1.5 mm, reduced fluid velocity across some pores while increasing it across the remaining pores. These structural modifications essentially diverted fluid flow across the pores without reducing fluid interaction. In contrast, shifting the septum pores by 1 mm improved velocity across all pores. These structural changes redirected fluid flow along a more optimal path, minimizing fluid interaction. Enlarging the septum pores along the septum increased fluid velocity primarily at the most distal pores, while shifting the septum pores proximally improved fluid velocity primarily at the most proximal pores. Furthermore, the Catheter Concept G, with its 80:20 drain-to-flush lumen ratio, is advantageous for drainage during nominal abscess drainage procedures. Flushing intensity would be slightly affected, as the fluid velocity at wall hole 18d was observed to decrease by 0.20 m / s (21%) and the fluid velocity at wall hole 18a was observed to increase by 0.18 m / s (13%). CFD analysis shows that changes in the internal catheter structure can result in significant hydrodynamic changes in dual-lumen catheters during flushing.

[0082] Caveats and limitations of the CFD analysis include the assumption that the fluid is homogeneous, whereas in clinical use cases, the drainage lumen may contain more viscous materials. Furthermore, this steady-state analysis largely ignores transient fluid interactions during startup. It was theorized that a high fluid flow rate would quickly achieve steady-state flow within the relatively small volume of the catheter. The limitations of the steady-state CFD analysis were compensated for by physical benchtop testing. While these limitations may affect the fidelity of the CFD results, the results provide reasonable and practical knowledge for virtual rapid prototyping, without the need to build numerous expensive prototypes.

[0083] Additional operating conditions and structural parameters can further improve flushing. For example, the strength of the flush pump and / or suction pump can be adjusted by manipulating the fluid velocity profile. During the CFD analysis, only the flushing phase of the catheter was analyzed. However, the catheter can perform several different operations, such as performing drain lumen drainage while a flushing operation is simultaneously performed to clean the drain lumen.

[0084] [Methods for percutaneous drainage]

[0085] 21 illustrates an exemplary method 1000 for percutaneous drainage of a drainage site. Method 1000 may begin at step 1100, which includes inserting a catheter into the drainage site. The catheter includes a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter, a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter, a drain lumen defined by the catheter wall and a first portion of the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter, and a flush lumen defined by a second portion of the catheter wall and the septum and extending from the proximal end portion of the catheter to the distal end portion of the catheter and separated from the drain lumen by the septum. The septum is disposed within the distal end of the catheter. The catheter wall has at least one septum hole disposed proximate the end portion such that the drain lumen and the flush lumen are in communication through the at least one septum hole, and the catheter wall has at least one wall hole disposed proximate the distal end portion of the catheter such that the drain lumen is in communication with the drainage site when the distal end portion is positioned within the drainage site. In step 1200, the method may include withdrawing fluid from the drainage site through the drain lumen. In step 1300, the method may include identifying an occlusion in the drain lumen. In step 1400, the method may include flowing an irrigation fluid through the flush lumen to flush the drain lumen through the at least one septum hole, thereby removing the occlusion. In accordance with the disclosed subject matter, the method may repeat one or more steps of the method of FIG. 21 as necessary. Although the present disclosure describes and illustrates certain steps of the method of FIG. 21 as being performed in a particular order, the present disclosure contemplates any suitable steps of the method of FIG. 21 being performed in any suitable order. Additionally, although this disclosure describes and illustrates an example method for percutaneous drainage of a drainage site that includes certain steps of the method of Figure 21, this disclosure contemplates any suitable method for percutaneous drainage of a drainage site that may include all, some, or none of the steps of the method of Figure 21, as appropriate, and may include any suitable steps. Additionally, although this disclosure describes and illustrates certain components, devices, or systems that perform certain steps of the method of Figure 21, this disclosure contemplates any suitable combination of any suitable components, devices, or systems that perform any suitable steps of the method of Figure 21.

[0086] When system 100 is used for percutaneous pleural fistula surgery, the sensor / microcontroller system can be further programmed to detect the presence, persistence, and / or resolution of pneumothorax, air leaks, and / or bronchopleural fistulas. When system 100 is used for percutaneous chemical ablation and / or sclerosing of cystic lesions, recurrent fluid collections (such as lymphoceles and other disorders of the lymphatic system), and / or hollow viscus (such as the gallbladder of a candidate deemed unsuitable for cholecystectomy), the system can monitor the volume, residence time, irrigation, simultaneous or delayed aspiration, and repeated cycles of injected sclerosant / polymer adhesive. In such uses, catheter 10 may have side holes along both of its outer walls 11, eliminating the need for septum holes 17. If the system is used for percutaneous esophagogastrostomy, gastrojejunostomy, jejunostomy, and / or cecostomy (i.e., gastrointestinal / alimentary tract), the system can include programmable tube feeding settings for patient-specific nutritional needs, and tube flushing settings to maintain lumen patency.

[0087] [Enteral nutrition]

[0088] With reference to FIG. 22, system 100C is configured for use with an enteral (e.g., gastrostomy, gastrojejunostomy, jejunostomy) feeding catheter (e.g., enteral tube 72). For example, an indwelling percutaneous gastrostomy catheter 71 can deliver a liquid nutritional formula from a container 73 to the stomach via infusion of a peristaltic pump 102a. A pressure sensor 75 installed along the tubing between the container 73 and the indwelling percutaneous gastrostomy catheter 71 allows for detection of lumen blockage due to clumps of feed or other particulate matter. In the event of blockage, control unit 60 activates a second peristaltic pump 102b attached to a container 74 filled with sterile water or saline, thereby enabling powered flushing and restoration of tube patency. Flushing can also be scheduled periodically at a preset volume and pressure for tube maintenance. An optional syringe pump 76 allows for administration of prescribed medications via enteral tube 72.

[0089] The disclosed subject matter is intended to be illustrative and not limiting, and specific preferred embodiments Although described herein with respect to, it will be understood by those skilled in the art that various modifications and improvements can be made to the disclosed subject matter without departing from the scope thereof. Moreover, although individual features of one embodiment of the disclosed subject matter may be discussed herein or shown in the drawings of one embodiment and not shown in other embodiments, it will be readily apparent that individual features of one embodiment can be combined with one or more features of another embodiment or with features from multiple embodiments.

[0090] In addition to the specific embodiments claimed below, the disclosed subject matter is also directed to other embodiments having any other possible combinations of the dependent features claimed below and the dependent features disclosed above. Thus, the specific features presented in the dependent claims and disclosed above can be combined with each other in other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to the disclosed embodiments.

[0091] It will be apparent to those skilled in the art that various modifications and variations can be made in the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter cover modifications and variations that come within the scope of the appended claims and their equivalents.

[0092] The following appendices are included in this disclosure. (Additional note 1) 1. A system for percutaneous drainage of a drainage site, comprising: The system comprises: a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter disposed within the drainage site; a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter; a drain lumen defined by the catheter wall and a first portion of the septum, the drain lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter; a catheter having a flush lumen defined by the catheter wall and a second portion of the septum, the flush lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter, and separated from the drain lumen by the septum; a drain tube having a first end coupled to the drain lumen at the proximal end portion of the catheter and a second end coupled to a waste collection container; a first pump coupled to the drain tube between the first end of the drain tube and the second end of the drain tube; a flush tube having a first end coupled to the flush lumen at the proximal end portion of the catheter and a second end coupled to a flush material container having a flush material disposed therein; a second pump coupled to the flash tube between the first end of the flash tube and the second end of the flash tube; a controller coupled to the first pump and the second pump for controlling the first pump and the second pump; Equipped with providing at least one septum hole in the septum adjacent the distal end portion of the catheter, such that the drain lumen and the flush lumen communicate through the at least one septum hole; The catheter wall has at least one wall hole positioned adjacent to the distal end portion of the catheter, so that the drain lumen communicates with the drainage site when the distal end portion of the catheter is positioned within the drainage site. (Additional note 2) The system of claim 1, wherein the volume of the drain lumen is equal to the volume of the flush lumen. (Additional note 3) The system of claim 1, wherein the volume of the drain lumen is greater than the volume of the flush lumen. (Additional note 4) 10. The system of claim 1, wherein the at least one partition hole includes a plurality of partition holes. (Additional note 5) 10. The system of claim 1, wherein the at least one septum hole comprises a distal hole having a first diameter and a proximal hole having a second diameter, the second diameter being different from the first diameter. (Additional note 6) 6. The system of claim 5, wherein the second diameter is smaller than the first diameter. (Additional note 7) 10. The system of claim 1, wherein the at least one septum hole and the at least one wall hole are offset. (Additional note 8) 10. The system of claim 1, further comprising a pressure sensor coupled to the drain tube and the controller. (Additional note 9) The system of claim 1, further comprising a housing in which the first pump, the second pump, and the controller are disposed. (Additional note 10) 10. The system of claim 1, further comprising an injection port coupled to the flash tube. (Additional note 11) The system of claim 10, further comprising a syringe connected to the injection port by a third tube. (Additional note 12) The system of claim 10, further comprising a third pump coupled to the injection port by a third tube. (Additional note 13) 1. A catheter for percutaneous drainage of a drainage site, comprising: The catheter a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter disposed within the drainage site; a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter; a drain lumen defined by the catheter wall and a first portion of the septum, the drain lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter; a flush lumen defined by the catheter wall and a second portion of the septum, the flush lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter and separated from the drain lumen by the septum; Equipped with the septum having at least one septum hole disposed proximate a distal end portion of the catheter such that the drain lumen and the flush lumen are in communication through the at least one septum hole; The catheter wall has at least one wall hole located adjacent the distal end portion of the catheter such that the drain lumen communicates with the drainage site when the distal end portion is positioned within the drainage site. (Additional note 14) Item 14. The catheter of claim 13, wherein the volume of the drain lumen is equal to the volume of the flush lumen. (Additional note 15) Item 14. The catheter according to item 13, wherein the volume of the drain lumen is greater than the volume of the flush lumen. (Additional note 16) Item 14. The catheter of claim 13, wherein the at least one septum hole includes a plurality of septum holes. (Additional note 17) 14. The catheter of claim 13, wherein the at least one septum hole comprises a distal hole having a first diameter and a proximal hole having a second diameter, the second diameter being different from the first diameter. (Additional note 18) Item 18. The catheter according to item 17, wherein the second diameter is smaller than the first diameter. (Additional note 19) the at least one septum hole and the at least one wall hole are offset Item 14. The catheter according to item 13. (Additional note 20) 1. A method for percutaneous drainage of a drainage site, comprising: a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter disposed within the drainage site; a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter; a drain lumen defined by the catheter wall and a first portion of the septum, the drain lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter; a flush lumen defined by the catheter wall and a second portion of the septum, the flush lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter and separated from the drain lumen by the septum; A catheter comprising: the septum having at least one septum hole disposed proximate a distal end portion of the catheter such that the drain lumen and the flush lumen are in communication through the at least one septum hole; the catheter wall having at least one wall hole disposed proximate the distal end portion of the catheter such that the drain lumen communicates with the drainage site when the distal end portion is disposed within the drainage site; inserting the catheter into a drainage site; withdrawing fluid from the drainage site through the drain lumen; identifying an obstruction within the drain lumen; and flowing a flushing fluid through the at least one septum hole, through the flush lumen, and into the drain lumen to remove the blockage. (Additional note 21) 21. The method of claim 20, further comprising temporarily suspending the withdrawal of fluid from the drainage site through the drain lumen. (Additional note 22) 22. The method of claim 21, wherein the pausing step further comprises reversing the direction of flow of the fluid in the drain lumen. (Additional note 23) 22. The method of claim 21, further comprising resuming the withdrawal of the fluid from the drainage site through the drain lumen. (Additional note 24) 22. The method of claim 21, further comprising the step of monitoring the rate of fluid withdrawal from the drainage site. (Additional note 25) 25. The method of claim 24, further comprising monitoring the rate of change of the rate of withdrawal of the fluid from the drainage site. (Additional note 26) The method of claim 25, wherein the step of identifying an obstruction in the drain lumen is based at least in part on one or more of the rate of withdrawal of the fluid from the drainage site and the rate of change of the rate of withdrawal of the fluid from the drainage site. (Additional note 27) 22. The method of claim 21, further comprising monitoring the pressure in the excretion lumen. (Additional note 28) 28. The method of claim 27, further comprising monitoring the rate of change of the pressure in the excretion lumen. (Additional note 29) The method of claim 28, wherein the step of identifying an obstruction in the drain lumen is based at least in part on one or more of the pressure in the drain lumen and the rate of change of the pressure in the drain lumen. (Additional note 30) 1. A system for percutaneous drainage of a drainage site, comprising: a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter disposed within the drainage site; a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter; a drain lumen defined by the catheter wall and a first portion of the septum, the drain lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter; a catheter having a flush lumen defined by the catheter wall and a second portion of the septum, the flush lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter, and separated from the drain lumen by the septum; a drain tube having a first end coupled to the drain lumen at the proximal end portion of the catheter and a second end coupled to a waste collection container; a first pump coupled to the drain tube between the first end of the drain tube and the second end of the drain tube; a flush tube having a first end coupled to the flush lumen at the proximal end portion of the catheter and a second end coupled to a flush material container having a flush material disposed therein; a second pump coupled to the flash tube between the first end of the flash tube and the second end of the flash tube; a controller coupled to the first pump and the second pump for controlling the first pump and the second pump; Equipped with the first portion of the catheter wall has at least a first wall hole disposed proximate the distal end portion of the catheter such that the drain lumen communicates with the drainage site when the distal end portion of the catheter is positioned within the drainage site; The second portion of the catheter wall has at least a second wall hole positioned proximate the distal end portion of the catheter such that the flush lumen communicates with the drainage site when the distal end portion of the catheter is positioned within the drainage site.

Claims

1. 1. A catheter for percutaneous drainage of a drainage site, comprising: The catheter a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter disposed within the drainage site; a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter; a drain lumen defined by the catheter wall and a first portion of the septum, the drain lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter; a flush lumen defined by the catheter wall and a second portion of the septum, the flush lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter and separated from the drain lumen by the septum; Equipped with the septum has at least one septum hole disposed proximate a distal end portion of the catheter such that the drain lumen and the flush lumen communicate through the at least one septum hole; The catheter wall has at least one wall hole located adjacent to the distal end portion of the catheter such that the drain lumen communicates with the drainage site when the distal end portion is positioned within the drainage site.

2. The catheter of claim 1 , wherein the volume of the drain lumen is equal to the volume of the flush lumen.

3. The catheter of claim 1 , wherein the volume of the drain lumen is greater than the volume of the flush lumen.

4. The catheter of claim 1 , wherein the at least one septum hole comprises a plurality of septum holes.

5. 10. The catheter of claim 1, wherein the at least one septum hole comprises a distal hole having a first diameter and a proximal hole having a second diameter, the second diameter being different from the first diameter.

6. The catheter of claim 5 , wherein the second diameter is smaller than the first diameter.

7. the at least one septum hole and the at least one wall hole are offset; The catheter of claim 1 .

8. 1. A method for percutaneous drainage of a drainage site, comprising: a catheter wall extending from a proximal end portion of the catheter to a distal end portion of the catheter disposed within the drainage site; a septum disposed within the catheter wall and extending from the proximal end portion of the catheter to the distal end portion of the catheter; a drain lumen defined by the catheter wall and a first portion of the septum, the drain lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter; a flush lumen defined by the catheter wall and a second portion of the septum, the flush lumen extending from the proximal end portion of the catheter to the distal end portion of the catheter and separated from the drain lumen by the septum; A catheter comprising: the septum has at least one septum hole disposed proximate a distal end portion of the catheter such that the drain lumen and the flush lumen communicate through the at least one septum hole; the catheter wall having at least one wall hole disposed proximate the distal end portion of the catheter such that the drain lumen communicates with the drainage site when the distal end portion is disposed within the drainage site; inserting the catheter into a drainage site; withdrawing fluid from the drainage site through the drain lumen; identifying an obstruction within the drain lumen; and flowing a flushing fluid through the at least one septum hole, through the flush lumen, and into the drain lumen to remove the blockage.

9. The method of claim 8 , further comprising suspending the withdrawal of the fluid from the drainage site through the drain lumen.

10. The method of claim 9 , wherein the step of pausing further comprises the step of reversing the direction of flow of the fluid in the drain lumen.

11. 10. The method of claim 9, further comprising resuming the drawing of the fluid from the drainage site through the drain lumen.

12. 10. The method of claim 9, further comprising monitoring the rate of fluid withdrawal from the drainage site.

13. The method of claim 12, further comprising monitoring the rate of change of the rate of withdrawal of the fluid from the drainage site.

14. 14. The method of claim 13, wherein identifying an obstruction in the drain lumen is based at least in part on one or more of a rate of withdrawal of the fluid from the drainage site and a rate of change of the rate of withdrawal of the fluid from the drainage site.

15. The method of claim 9 further comprising monitoring the pressure in the flush lumen.

16. 16. The method of claim 15, further comprising monitoring the rate of change of the pressure in the flush lumen.

17. 17. The method of claim 16, wherein identifying an obstruction in the drain lumen is based at least in part on one or more of the pressure in the drain lumen and a rate of change of the pressure in the drain lumen.

Images