Systems for aspirating and irrigating body cavities and associated devices and methods
Through a coaxially designed suction and flushing system, combined with high-pressure syringes and mechanical destroyers, the efficient drainage problems of complex abdominal abscesses and pleural effusions are solved, and rapid and thorough improvement of intraluminal substance removal and drainage efficiency are achieved.
Patent Information
- Application Number
- CN202380088792.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-11-18
- Filing Date
- 2023-11-10
- Publication Date
- 2025-07-22
AI Technical Summary
The prior art is difficult to efficiently empty complex abdominal abscesses and pleural effusions, conventional drainage catheters are prone to clogging, and flushing technology cannot effectively reduce the viscosity of substances in the cavity, resulting in low drainage efficiency.
A coaxial design suction and flushing system is adopted, including an inner catheter and an outer catheter. The outer catheter surrounds the inner catheter and flushes the substance in the cavity through the inner catheter. The outer catheter is flushed. The pressure difference is maximized by using a large diameter and high-pressure syringe, and combined with a mechanical destroyer to assist in the treatment of difficult-to-suck substances.
It achieves rapid and thorough removal of complex abdominal abscesses and pleural effusions, reduces the risk of blockage, reduces the viscosity of substances in the cavity, improves drainage efficiency, and shortens treatment time.
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Figure CN120359060A_ABST
Abstract
Description
[0001] Cross - Reference to Related Applications
[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 383,440, filed on November 11, 2022, entitled "SYSTEMS FOR ASPIRATING AND IRRIGATING BODY CAVITIES, AND ASSOCIATED DEVICES AND METHODS", and U.S. Provisional Patent Application No. 63 / 426,560, filed on November 18, 2022, entitled "SYSTEMS FOR ASPIRATING AND IRRIGATING BODY CAVITIES, AND ASSOCIATED DEVICES AND METHODS", the entire contents of each of which are incorporated herein by reference in their entirety. Technical Field
[0003] The present technology generally relates to systems for aspirating, irrigating, and / or mechanically disrupting substances within body cavities such as abdominal abscesses, empyemas, and / or (e.g., complex) pleural effusions. Background Art
[0004] Abdominal abscesses and pleural effusions are accumulations that fill body cavities with a low - viscosity sterile serosanguinous fluid. If the accumulation is large enough, percutaneous drainage may be performed to drain the accumulation contents. Drainage is typically performed by using an indwelling percutaneous drainage catheter, which is usually left in place for less than a week for simple accumulations. As the disease state progresses further, pleural effusions may become complex pleural / parapneumonic effusions or empyemas, both of which involve infection of the cavity contents. Intra - abdominal abscesses may also become infected, leading to a more complex presentation.
[0005] Such complex abdominal abscess collections, pleural effusions, and empyemas may produce thick, viscous pus (purulent fluid) that contains necrotic debris, blood clots, intestinal contents, and / or multiple septated cavities. The septated cavities are contained within fibrin membranes (e.g., septal structures) that form distinct fluid-filled cystic cavities within a single cavity. The progression of these disease states into complex presentations greatly challenges the current ability of percutaneous drainage to efficiently and completely evacuate the collections. For example, current indwelling drainage devices are limited by the inner lumen size, the diameter of the drainage side holes, the number of drainage side holes, stenosis along the fluid path (e.g., stopcock valves), the length of the fluid path, and the pressure differential between the inlet (abscess) and the outlet (collection bag). Although drainage devices have improved in size, shape, and suction over time, current technology still struggles to evacuate complex collections. This is evidenced by the need for multiple drainage devices within the same collection, multiple drainage device replacements due to blockage or misalignment, long durations of drainage (days to months), the use of agents to compensate for drainage inefficiencies, and the use of off-label devices to make the collections more amenable to percutaneous drainage.
[0006] Some thrombectomy devices have been used off-label for mechanical debridement of cavities. These devices are not targeted and / or lack precise spatial control. Additionally, agents such as tissue plasminogen activator (tPA) and deoxyribonuclease (DNase) have been administered to liquefy the collections and accelerate drainage by reducing the viscosity of the fluid; however, most regimens are labor-intensive and time-consuming.
[0007] In addition, drainage catheters require daily flushing with a small amount of sterile saline to prevent catheter blockage and impede flow. Flushing is intended to clear the catheter and maintain its patency, while irrigation means to loosen debris and reduce the viscosity of the local contents within the collection. Irrigation techniques have been performed using current drainage catheters. For such techniques, a large volume of sterile saline is flushed through the placed percutaneous drainage device and immediately aspirated. This method can also effectively clear a blocked drainage device, but pushes the debris already within the drainage device back into the cavity, potentially allowing the debris to block the drainage device again later. Sometimes, using two separate drainage devices within a single cavity can reduce blockage after irrigation. BRIEF DESCRIPTION OF THE DRAWINGS
[0008] Many aspects of the technology of the present invention can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the disclosure.
[0009] Figure 1A is a partial schematic side view of a suction and irrigation system according to an embodiment of the present technology.
[0010] Figure 1B is according to an embodiment of the present technologyFigure 1A An enlarged side perspective view of the distal portion of the catheter assembly of the system shown.
[0011] Figure 1C is of a Figure 1A distal portion of a catheter assembly according to an embodiment of the present technology.
[0012] Figure 2A and Figure 2B are a side view and an enlarged partial schematic side view of a pressure source assembly and a flush assembly of a Figure 1A system according to an embodiment of the present technology.
[0013] Figures 3A to 3C are respectively enlarged side views of a mechanical disruptor assembly in a compressed position, a partially expanded position, and an expanded position according to an embodiment of the present technology, the mechanical disruptor assembly being configured to be advanced through Figure 1A a catheter assembly of
[0014] Figure 3D is of a Figures 3A to 3C handle of a mechanical disruptor assembly according to an embodiment of the present technology.
[0015] Figure 4 is a flow chart of a process or method for treating a patient's body cavity using a Figure 1A system of
[0016] Figures 5A to 5E is of a Figure 1A distal portion of a catheter assembly of Figure 4 during different stages of a
[0017] Figure 6 is a side view of a suction and flush system according to an additional embodiment of the present technology.
[0018] Figure 7A is of a Figure 6 catheter assembly of a
[0019] Figure 7B is of a Figure 7A catheter assembly in which a dilator is inserted according to an embodiment of the present technology.
[0020] Figure 8A and Figure 8B are enlarged side views of the distal portion of an elongate member of a Figure 6 catheter assembly according to an embodiment of the present technology. Detailed Description
[0021] The present technology generally relates to systems for aspirating, irrigating, and / or mechanically disrupting substances / contents within body cavities such as abdominal abscesses, empyemas, and / or (e.g., complicated) pleural effusions, as well as associated devices and methods. In some embodiments, an aspiration and irrigation system constructed in accordance with the present technology includes an inner catheter defining an aspiration lumen and an outer tube positioned coaxially about the inner catheter and defining an irrigation lumen. A distal portion of the outer tube may be fluidly sealed to the inner catheter, and a plurality of holes may be formed through the outer tube proximal to the fluidly sealed portion. The aspiration lumen can be fluidly coupled to an aspiration circuit configured to aspirate the aspiration lumen, and the irrigation lumen can be fluidly coupled to an irrigation circuit configured to flow irrigation fluid through the irrigation lumen and out the holes. The catheter assembly can be positioned within a body cavity, and the aspiration circuit can be operated to aspirate substances from an abscess. At the same or different times, the irrigation circuit can be operated to irrigate the cavity with irrigation fluid to, for example, break down (e.g., loosen) substances within the cavity and / or reduce the viscosity of substances within the cavity.
[0022] In some aspects of the present technology, the aspiration and irrigation system (i) maximizes the area of the aspiration lumen along the entire length of the aspiration lumen, (ii) provides a powerful circumferential irrigation to reduce the viscosity of the cavity contents and break down septations and other large debris, and (iii) separates the aspiration circuit and the irrigation circuit. The catheter assembly permits a physician to rapidly irrigate and aspirate large, complicated collections, saving drain management time and overcoming recurrent drain blockages. During an initial treatment protocol, the aspiration and irrigation system can be used to evacuate complicated substances, thereby rendering the collection suitable for drainage with currently available drainage catheters. Alternatively, the aspiration and irrigation system can be used for collections that are not evacuated by currently available drainage catheters.
[0023] The aspiration and irrigation system can be designed to maximize the flow of substances by utilizing Poiseuille's law as defined below. In some embodiments, the pressure differential is maximized by using an aspiration source that includes a 60 cc syringe capable of creating a vacuum of -25.5 inHg when fully evacuated. The aspiration catheter radius can be maximized by maintaining a single lumen with the same diameter from the distal tip of the aspiration catheter to the syringe by utilizing a large-bore side port tubing and a large-bore syringe. The fluid viscosity can be reduced via an irrigation process that dilutes the cavity contents. The length of the system can be minimized by maintaining a minimum distance between the tip of the catheter and the aspiration source / syringe. In contrast, current drains typically use an overly long tubing length to connect to a gravity collection bag, wall suction, or suction bulb, which reduces the efficiency of the drain.
[0024] In cases where the contents within the cavity are too viscous or too large for the aspiration catheter, mechanical elements may be employed. The mechanical elements may have a size and shape that can be safely controlled into a desired geometry and manipulated within the cavity to assist with subsequent aspiration and drainage.
[0025] In the following description and in FIGS. 1 through Figure 8B Some details are set forth in order to provide a thorough understanding of the various embodiments of the present technology. In other instances, well-known structures, materials, operations, and / or systems typically associated with percutaneous procedures, body cavity substance removal procedures, catheters, etc. are not shown or described in detail in the following disclosure so as not to unnecessarily obscure the description of the various embodiments of the present technology. Additionally, although primarily referencing aspiration and drainage catheters for removing substances from body cavities, the catheters of the present technology can be other types of catheters and / or can be used in other types of medical procedures. However, one of ordinary skill in the art will recognize that the present technology can be practiced without one or more of the details set forth herein and / or with other structures, methods, components, etc.
[0026] The terms used hereinafter are to be interpreted in the broadest reasonable manner, even if used in conjunction with a detailed description of some embodiments of the present disclosure. Indeed, certain terms may even be emphasized hereinafter; however, any terms intended to be interpreted in any restricted manner will be disclosed and specifically defined in the detailed description section of this specification.
[0027] The accompanying drawings depict embodiments of the present technology and are not intended to limit its scope unless explicitly stated. The dimensions of the various depicted elements are not necessarily drawn to scale, and these various elements may be enlarged to improve readability. Component details may be separated in the figures to exclude such details when details such as the location of components and certain precise connections between such components are not necessary for a complete understanding of how to make and use the present technology. Many of the details, dimensions, angles, and other features shown in the drawings are merely illustrative of particular embodiments of the present disclosure. Thus, other embodiments may have other details, dimensions, angles, and features without departing from the present technology. Additionally, one of ordinary skill in the art should understand that other embodiments of the present technology can be practiced without several of the details described below.
[0028] Regarding the terms "distal" and "proximal" in this specification, unless otherwise indicated, these terms may refer to the relative position of the various parts of a tube system with respect to an operator and / or their position within the vasculature. Additionally, as used herein, names such as "backward," "forward," "upward," "downward," etc. do not intend to limit the referenced components to a particular orientation. It should be understood that such names refer to the orientation of the referenced components as shown in the accompanying drawings; the systems of the present technology can be adapted for use in any orientation by the user.
[0029] As used herein, unless otherwise expressly indicated, the terms "about", "approximately", "substantially", etc. mean within ±10% of the stated value. If any substance incorporated by reference herein conflicts with the present disclosure, the present disclosure shall control.
[0030] Figure 1A is a partial schematic side view of a suction and irrigation system 100 ("system 100") according to an embodiment of the present technology. In the illustrated embodiment, system 100 includes a catheter assembly 110 that (i) is fluidly coupled to a valve 102, (ii) is fluidly coupled to a first conduit assembly 120 via a first fitting 104, and (iii) is fluidly coupled to a second conduit assembly 130 via a second fitting 106. System 100 may include a number of features that are generally similar or identical to those of the clot treatment system described in detail in U.S. Patent Application No. 16 / 536,185, filed on August 8, 2019, and entitled "SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS", which is hereby incorporated by reference in its entirety.
[0031] Figure 1B is according to an embodiment of the present technology Figure 1A is an enlarged side perspective view of a distal portion of the illustrated catheter assembly 110. In the illustrated embodiment, catheter assembly 110 extends along an axis L (e.g., a longitudinal axis) and includes an inner elongate member 112 (which may also be referred to as an inner sheath, inner tube, inner catheter, suction member, suction sheath, suction tube, suction catheter, etc.) and an outer elongate member 114 (which may also be referred to as an outer sheath, outer tube, outer catheter, irrigation member, irrigation sheath, irrigation tube, irrigation catheter, etc.), the outer elongate member being positioned coaxially at least partially around the inner elongate member 112. For clarity, the outer elongate member 114 is shown in Figure 1Bis shown as being partially transparent. The inner elongate member 112 can be a reinforced thin-walled catheter. In some embodiments, the inner elongate member 112 can include some features that are at least generally similar or identical in structure and function to those of the catheters disclosed in (i) U.S. Patent Application Publication No. 17 / 529,018, filed on November 17, 2021, and titled "CATHETERS HAVING SHAPED DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS" and / or (ii) U.S. Patent Application Publication No. 17 / 529,064, filed on November 17, 2021, and titled "CATHETERS HAVING STEERABLE DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS", the entire disclosures of each of which are incorporated herein by reference. The outer elongate member 114 can be a tube formed of a plastic material, an elastomeric material, and / or a thermoplastic elastomer (TPE) material (such as a TPE manufactured by Arkema S.A., of Colombes, France, such as a TPE manufactured under the trademark "Pebax"). In other embodiments, the outer elongate member 114 can be a reinforced thin-walled catheter. The outer elongate member 114 can have a size between about 6 French units and 30 French units, such as a size of 6 French units, 8 French units, 12 French units, 16 French units, 20 French units, 24 French units, 26 French units, or 30 French units. The inner elongate member 112 can have a size smaller than that of the outer elongate member 114, and this size is about 1 French unit to 8 French units smaller than the outer elongate member 114.
[0032] Figure 1C is an enlarged distal-facing perspective view of a distal portion of a catheter assembly 110 according to an embodiment of the present technology. Refer to Figure 1B and Figure 1C , the distal end portion 115a of the outer elongate member 114 can be fluidly sealed to / with (e.g., coupled to, mechanically attached to, bonded to, attached to, etc.) the distal portion 113a (e.g., distal end portion) of the inner elongate member 112. Refer to Figure 1A , the proximal end portion 113b of the inner elongate member 112 can be coupled to (e.g., bonded to) the first fitting 104 and / or the valve 102, and the proximal end portion 115b of the outer elongate member 114 can be coupled to (e.g., bonded to) the second fitting 106.
[0033] Reference Figure 1B Figure 1B , an inner elongated member 112 defines an inner lumen 111 (e.g., a suction lumen), and an outer elongated member 114 defines an outer lumen 117 (e.g., a flushing lumen). The inner lumen 111 can be accessed via a distal opening 119 (e.g., a suction opening) at a distal portion 113a of the inner elongated member 112. Reference Figure 1B and Figure 1C Figure 1C , a distal end portion 115a of the outer elongated member 114 includes / defines one or more (e.g., a plurality of) circumferentially distributed holes 118 (e.g., apertures) that are fluidly coupled / connected to the outer lumen 117. As described in further detail below, the holes 118 can serve as outlets for flushing fluid, a targeted drug, and / or another fluid to flow from the outer lumen 117 to the exterior of the catheter assembly 110. In the illustrated embodiment, the holes 118 have a circular shape. The size of the holes 118, the shape of the holes 118, the clearance between the outer elongated member 114 and the inner elongated member 112, and / or the lumen diameter of a second catheter assembly 130 ( Figure 1A Figure 1A ) that includes conduit sections 132a to 132b and a fluid control device 134 can be controlled (e.g., selected) to permit forceful infusion of flushing fluid through the holes 118. Additionally, the number of holes 118, the size of the holes 118, the shape of the holes 118 (e.g., circular, square, rectangular, linear, polygonal, irregular, etc.) can be adjusted to adjust the jet angle of the flushing fluid exiting the holes 118. In some embodiments, the distal opening 119 extends in a plane orthogonal to an axis L, and the holes 118 extend in a plane different from the plane of the distal opening 119 (e.g., a plane orthogonal to the distal opening 119). In some embodiments, the holes 118 are fluidly coupled / connected to the outer lumen 117 at the distal end portion 115a of the outer elongated member 114, where the distal end portion 115a (the portion that is fluidly coupled / connected) extends proximally such that there is a longer distance between the distal opening 119 and the holes 118.
[0034] Reference Figures 1A to 1C, the inner lumen 111 is fluidly coupled to a first conduit assembly 120 via a first fitting 104, and the outer lumen 117 is fluidly coupled to a second conduit assembly 130 via a second fitting 106. A valve 102 is fluidly coupled to the inner lumen 111 of the inner elongate member 112. In some embodiments, the valve 102 is an actuated access valve configured to maintain fluid control during a body cavity treatment procedure by inhibiting or preventing fluid from flowing through the valve 102 in the proximal direction when various components such as a delivery sheath, a pull member, a guide wire, an intervention device, a mechanical disruptor assembly, other aspiration catheters, etc. are inserted through the valve 102 for delivery to a treatment site in a body cavity via the inner elongate member 112. In some embodiments, the valve 102 can be of the type disclosed in U.S. Patent Application No. 16 / 117,519, filed Aug. 30, 2018, entitled "HEMOSTASIS VALVES AND METHODS OF USE", which is hereby incorporated by reference in its entirety.
[0035] In the illustrated embodiment, the first conduit assembly 120 fluidly couples the inner lumen 111 of the inner elongate member 112 of the catheter assembly 110 to a pressure source assembly 140, such as a syringe and one or more valves, as described in detail below with reference to Figure 2A and Figure 2B Similarly, the second conduit assembly 130 fluidly couples the outer lumen 117 of the outer elongate member 114 to a flush assembly 150, such as a syringe and one or more valves, as described in detail below with reference to Figure 2A and Figure 2B In reference to Figure 1A , the first conduit assembly 120 and the second conduit assembly 130 (the "conduit assemblies 120, 130") can be substantially similar or identical. For example, in the illustrated embodiment, the first conduit assembly 120 includes one or more conduit segments 122 (individually labeled as a first conduit segment 122a and a second conduit segment 122b), at least one fluid control device 124 (e.g., a valve), and at least one connector 126 (e.g., a Toomey tip connector) for fluidly coupling the first conduit assembly 120 to the pressure source assembly 140 and / or other suitable components. Similarly, in the illustrated embodiment, the second conduit assembly 130 includes one or more conduit segments 132 (individually labeled as a first conduit segment 132a and a second conduit segment 132b), at least one fluid control device 134 (e.g., a valve), and at least one connector 136 (e.g., a Toomey tip connector) for fluidly coupling the second conduit assembly 130 to the flush assembly 150 and / or other suitable components. In reference to Figure 1A and Figure 1B, in some embodiments, the fluid control device 124 includes a plug valve that (i) is fluidly coupled to the inner lumen 111 of the inner elongate member 112 via a second conduit section 122b, and (ii) is fluidly coupled to the connector 126 via a first conduit section 122a. Similarly, the fluid control device 134 may include a plug valve that (i) is fluidly coupled to the outer lumen 117 of the outer elongate member 114 via a second conduit section 132b, and (ii) is fluidly coupled to the connector 136 via a first conduit section 132a. The fluid control devices 124, 134 may be externally operated by a user to regulate the flow of fluid therethrough and specifically from the inner lumen 111 of the catheter assembly 110 to the pressure source assembly 140 and from the flush assembly 150 to the outer lumen 117 of the catheter assembly, respectively. In some embodiments, the connectors 126, 136 are quick-release connectors (e.g., quick-disconnect fittings) that enable quick coupling / disconnection of the catheter assembly 110 with the pressure source assembly 140 and / or the flush assembly 150.
[0036] The system 100 may further include a dilator 108 that may be inserted through the inner lumen 111 of the elongate member 112 via the valve 102. The dilator 108 may include a proximal coupling portion 109 that is configured to be fixed to and / or mate with a corresponding portion of the valve 102. In some embodiments, the dilator 108 and / or the valve 102 may be of the type disclosed in U.S. Patent Application No. 18 / 156,944, filed on January 19, 2023, and titled "CLOT TREATMENT SYSTEMS WITH DILATOR LOCKING MECHANISMS, AND ASSOCIATED DEVICES AND METHODS", which is incorporated herein by reference in its entirety.
[0037] Figure 2A and Figure 2B are a side view and an enlarged partial schematic side view of the pressure source assembly 140 and the flush assembly 150 according to an embodiment of the present technology. Referring to Figure 2A and Figure 2B , the pressure source assembly 140 includes a pressure source 242 such as a syringe 242 having a barrel 243 and a plunger 244 slidable through the barrel 243, and a suction flow control assembly 245 fluidly coupled to the barrel 243. The suction flow control assembly 245 may include (i) a first connector 246, (ii) a second connector 247 (obscured in Figure 2A ), (iii) a first check valve 248 (obscured in Figure 2Bis schematically shown), the first one-way valve fluidly couples the first connector 246 to the barrel 243, and (iv) a second one-way valve 249 (shown schematically in Figure 2B is schematically shown), the second one-way valve fluidly couples the second connector 247 to the barrel 243 and the first one-way valve 248. Similarly, the flushing assembly 150 may include a pressure source 252 such as a syringe 252 having a barrel 253 and a plunger 254 slidable through the barrel 253, and a flushing flow control assembly 255 fluidly coupled to the barrel 253. The flushing flow control assembly 255 may include (i) a first connector 256, (ii) a second connector 257, (iii) a first one-way valve 258 (shown schematically in Figure 2B is schematically shown), the first one-way valve fluidly couples the first connector 256 to the barrel 253, and (iv) a second one-way valve 259 (shown schematically in Figure 2B is schematically shown), the second one-way valve fluidly couples the second connector 257 to the barrel 253 and the first one-way valve 258. In other embodiments, the pressure sources 242, 252 may be other types of fluid pressure pumps or sources. In some embodiments, the plungers 244, 254 are coupled together via a handle 264 ( Figure 2A ), such that the plungers 244, 254 are constrained to move together. In other embodiments, the syringes 242, 252 may be separated such that they can be operated independently and / or may have different sizes. In some embodiments, the syringes 242, 252 may have a volume of about 60 cubic centimeters and may have large-bore connectors of the type described in U.S. Patent Application No. 16 / 536,185, filed on August 8, 2019, and titled "SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS", which is hereby incorporated by reference in its entirety.
[0038] Referring to Figures 1A to 2B , the first connector 246 of the pressure source assembly 140 may be connected to the connector 126 of the first conduit assembly 120 to fluidly couple the inner lumen 111 of the catheter assembly 110 to the syringe 242, and the first connector 256 of the flushing assembly 150 may be connected to the connector 136 of the second conduit assembly 130 to fluidly couple the outer lumen 117 of the catheter assembly 110 to the syringe 252. Referring to Figure 2B, the second connector 247 of the pressure source assembly 140 can be connected to a waste reservoir 260 (e.g., a waste bag), and the second connector 257 of the flushing assembly 150 can be connected to a flushing reservoir 262 (e.g., a saline bag) configured to hold a flushing fluid. The flushing fluid can be a sterile fluid with a relatively low viscosity, such as saline.
[0039] Figure 2B Arrow P above the suction flow control assembly 245 in 拉出 and P 推入 respectively illustrate the operation of the suction flow control assembly 245 when the plunger 244 is pulled out and pushed in. The first check valve 248 of the suction flow control assembly 245 can be positioned to allow fluid to flow through the first connector 246 (e.g., from the inner lumen 111) to the barrel 243 of the syringe 242 when the plunger 244 is pulled back (e.g., pulled out). Concurrently, the second check valve 249 of the suction flow control assembly 245 inhibits (e.g., prevents) fluid from flowing back from the waste reservoir 260 into the barrel 243 of the syringe 242. When the plunger 244 is pushed in (e.g., advanced), the second check valve 249 can be positioned to allow fluid to flow through the second connector 247 (e.g., from the barrel 243) to the waste reservoir 260. Concurrently, the first check valve 248 inhibits (e.g., prevents) fluid from flowing from the barrel 243 into the inner lumen 111.
[0040] Similarly, Figure 2B Arrow I above the flushing flow control assembly 255 in 拉出 and I 推入 respectively illustrate the operation of the flushing flow control assembly 255 when the plunger 254 is pulled out and pushed in. The second check valve 259 of the flushing flow control assembly 255 can be positioned to allow fluid to flow through the second connector 257 (e.g., from the flushing reservoir 262) to the barrel 253 of the syringe 252 when the plunger 254 is pulled back (e.g., pulled out). Concurrently, the first check valve 258 of the flushing flow control assembly 255 inhibits (e.g., prevents) fluid from flowing back from the first connector 256 into the barrel 253 of the syringe 252. When the plunger 254 is pushed in (e.g., advanced), the first check valve 258 can be positioned to allow fluid to flow through the first connector 256 (e.g., from the barrel 253) to the outer lumen 117. Concurrently, the second check valve 259 inhibits (e.g., prevents) fluid from flowing from the barrel 253 into the flushing reservoir 262.
[0041] Refer to Figures 1A to 2B, the catheter assembly 110 can be introduced into a patient's body through a percutaneous opening (e.g., an opening in the abdomen, an opening in an intercostal space) and advanced such that the distal portion of the catheter assembly 110 is positioned within and / or adjacent to a lumen in the patient's body. The proximal portion 109 of the dilator 108 can be disconnected from the valve 102, and the dilator 108 can be removed from the catheter assembly 110 within the body. Then, the handle 264 can be pulled to pull the plungers 244, 254 within the barrels 243, 253, respectively. Pulling of the plungers 244, 254 simultaneously (i) aspirates the inner lumen 111 of the inner elongate member 112 to aspirate material from the lumen, and (ii) fills (e.g., perfuses) the syringe 252 with flush fluid from the flush reservoir 262. Then, the handle 264 can be pushed to push the plungers 244, 254 within the barrels 243, 253, respectively. Pushing of the plungers 244, 254 simultaneously (i) empties the aspirated contents from the barrel 243 into the waste reservoir 260, and (ii) pushes the flush fluid from the barrel 253 into the outer lumen 117 of the outer elongate member 114 and through the aperture 118 into the lumen to flush the lumen. The operation of the system 100 is illustrated in Table 1 below:
[0042] Table 1
[0043]
[0044] In some aspects of the present technique, the operation of the syringe 242 can aspirate material from the lumen, while the operation of the syringe 252 can flush the lumen to disrupt and / or reduce the viscosity of the material therein. Simultaneous operation of the syringes 242 and 252 can ensure that the volume within the lumen remains constant such that the aspirated volume is replaced by the flush volume. In additional aspects of the present technique, the aspiration circuit 140 and the flush circuit 150 are independently controlled by the first check valve 248 and the second check valve 249 of the aspiration flow control assembly 245 and the first check valve 258 and the second check valve 259 of the flush flow control assembly 255, respectively, which aspiration flow control assembly and flush flow control assembly are connected to the syringes 242, 252, respectively. The flow control assemblies can ensure that each of the inner lumen 111 and the outer lumen 117 is a one-way path such that the flush aperture 118 is not blocked as may be possible for example with a conventional drain catheter side hole when placed in complex accumulations for aspiration. Further, during flushing, any contents within the aspiration lumen 111 will not be reintroduced into the lumen. That is, the flush fluid is introduced via the outer lumen 117 that is separate from the aspiration lumen 111 such that flushing does not reintroduce any aspirated material into the lumen and aspiration does not block the fluid path of the flush fluid.
[0045] Syringes 242, 252 can be actuated repeatedly to provide multiple instances of aspiration / irrigation. In some embodiments, system 100 can be used to treat a cavity in a single session and completely or substantially completely remove its contents, such that the cavity will be effectively drained at the initial treatment and no drainage catheter will need to be left in place. In other embodiments, after treating the cavity with system 100, a drainage catheter can be inserted into the cavity after the aspiration and irrigation procedures. System 100 can remain in the patient's body to act as a drainage system for a partial or entire drainage duration, and / or a separate drainage catheter (e.g., of a smaller size) can be inserted into the patient's body and system 100 can be removed for further drainage. That is, system 100 can be used to perform an initial debridement, drainage, and irrigation of the contents of the cavity, and then a standard commercial drainage piece can be inserted at the time of removing system 100 within the same procedure to allow for drainage of any remaining accumulation over the following days. In some aspects of the present technology, the use of system 100 can eliminate the need for off-label mechanical devices and agents for drainage, thereby improving patient outcomes and reducing the duration of drainage.
[0046] In additional aspects of the present technology, catheter assembly 110 can be optimized to maximize drainage (e.g., aspiration) flow rate. For example, catheter assembly 110 can be optimized in view of Poiseuille's law:
[0047]
[0048] where is the flow rate through the tube, is the pressure difference between the tube inlet and outlet, is the radius of the tube (shown in Figure 1B ), is the fluid viscosity, and is the tube length. Assuming that the pressure difference and length of catheter assembly 110 are constant between the aspiration catheter and a standard drainage catheter, the present technology can reduce the accumulation viscosity , while maintaining a large radius of the inner lumen 111 (e.g., the drainage lumen) Figure 1B . For example, introducing a flush fluid via outer lumen 117 can reduce the accumulation viscosity , while the coaxial arrangement of inner lumen 111 and outer lumen 117 can maximize the radius In contrast, some conventional double-lumen drainage devices (e.g., collection troughs) have been developed to facilitate drainage by providing a vent lumen. However, introducing such a secondary lumen compromises the radius of the collection lumen and thus reduces flow rate. Accordingly, system 100 can provide an optimal drainage catheter solution that (i) maximizes the drainage lumen (e.g., inner lumen 111) of the catheter assembly 110, (ii) reduces the viscosity of accumulates via flushing through the outer lumen 117, and / or (iii) breaks up septated cavities and debris via forceful flushing through the outer lumen 117.
[0049] Accordingly, system 100 can be designed to maximize the flow rate of substances by leveraging the Poiseuille's law as defined above. In some embodiments, the pressure differential is maximized by using a 60 cc syringe 242 that can create a vacuum of -25.5 inHg when fully emptied. By leveraging a large-bore side-port conduit (e.g., within the first conduit assembly 120) and a large-bore syringe 242 to maintain the same diameter of the single lumen from the distal tip to the syringe 242, the radius of the inner elongate member 112 is maximized. The fluid viscosity can be reduced via a flushing process that dilutes the cavity contents with a low-viscosity flushing fluid. The length of system 100 can be minimized by keeping the distance between the tip of the catheter assembly 110 and the vacuum source / syringe 242 as short as possible. In contrast, current drainage devices can use an overly long conduit length to connect to a gravity collection bag, a wall suction unit, or a suction bulb, which reduces the efficiency of the drainage device.
[0050] Compared to the present technology, typical double-lumen catheters (whether extruded or as part of a braided catheter) will face challenges in maintaining a reduced overall profile. Some common designs include a second lumen within or adjacent to the main suction lumen. These designs suffer from the problems of an overly long outer diameter and the single lumen for flushing being in the same plane as the suction lumen. In some aspects of the present technology, the two coaxial lumens 111, 117 provide several advantages for this application: (i) a continuous circular inner lumen 111 that is used to maximize the inlet area to the suction lumen 111, and (ii) a concentric reservoir that is used for circumferential (three-dimensional) flushing via the outer lumen 117. In some aspects of the present technology, circumferential flushing is important not only for reducing the viscosity of accumulates, but also for forcefully agitating local areas to potentially break up septated cavities and displace adherent substances. The three-dimensional pattern of the flushing fluid distributed via the holes 118 helps to provide a more dispersed and targeted flushing that is not limited to a single plane as in a single-lumen configuration. For example, a small single lumen (about 1 French unit to 4 French units) for infusion may only achieve local viscosity reduction without sufficiently disrupting the accumulates.
[0051] In other embodiments, the pressure source assembly 140 and / or the flush assembly 150 may be configured to provide more control and / or operate in a different manner. For example, the aspiration syringe 242 and the flush syringe 252 may be operated independently or have a separately predetermined volume for each stroke (e.g., by omitting the handle 264). In some embodiments, the fluid control device 124 may be closed during the retraction of the plunger 244 such that a vacuum is created (e.g., pre-charged) within the barrel 243 of the syringe 242. The fluid control device 124 may then be opened to apply a vacuum to the inner lumen 111 and create aspiration / suction pulses through the inner lumen 111. Additionally, although the first check valve 248 and the second check valve 249 are shown within the aspiration flow control assembly 245 and the first check valve 258 and the second check valve 259 are shown within the flush flow control assembly 255, in other embodiments, any one or all of the check valves 248, 249, 258, 259 may be directly incorporated into the catheter assembly 110, e.g., to avoid any confusion or mixing of the aspiration and flush circuits.
[0052] Reference Figures 1A to 1C , the system 100 may have various other configurations. For example, (i) the dilator 108 may be long-tipped or short-tipped for inserting the system 100 into a patient, (ii) the catheter assembly 110 may include a balloon tip for local flushing and retention within a lumen, and / or (iii) the distal portion of the catheter assembly 110 may have various curves (pigtail, J-hook, etc.; e.g., as Figures 7A to 8B shown). Additionally, in some embodiments, the outer lumen 117 may be omitted and the catheter assembly 110 may include / define only the inner lumen 111. Such embodiments may provide the benefit of maintaining large-bore aspiration / drainage with a simplified design without the ability to flush through a separate lumen. If desired, the large-bore lumen may still be used for flushing. Additionally, in some embodiments, the outer elongate member 114 may define a plurality of flush lumens extending between the second fitting 106 and corresponding one or more holes, such as hole 118. The individual flush lumens may be placed around the inner aspiration lumen 111 and may be formed via a multi-lumen extrusion process, a triaxial winding / weaving process, and / or another suitable process. The individual flush lumens may be circular or have other cross-sectional shapes.
[0053] Reference Figures 1A to 1C, in some embodiments, if the disruption of the contents of the lumen by flushing is insufficient (e.g., where the contents are too viscous or large to be aspirated after flushing), mechanical tools or elements can be deployed into the lumen through the inner lumen 111 of the catheter assembly 110. In some embodiments, the mechanical elements are similar to those used in thrombectomy. The mechanical elements can have a size and shape that can be controlled to form a desired geometry and be manipulated within the lumen to assist with subsequent aspiration and drainage. Figures 3A to 3C are, for example, enlarged side views of a mechanical disruptor assembly 370 in a compressed position, a partially expanded position, and an expanded position, respectively, according to an embodiment of the present technology, the mechanical disruptor assembly being configured to be advanced through the catheter assembly 110 into the lumen to mechanically disrupt the material therein. Refer to Figures 3A to 3C , the mechanical disruptor assembly 370 includes a disruptor element 371 that includes a plurality of interconnected struts and has a proximal portion 372 fixed to a first elongate shaft 373 and a distal portion 374 fixed to a second elongate shaft 375. The second elongate shaft 375 is slidably disposed within the first elongate shaft 373. One or more of the struts can have sharp cutting edges, and / or one or more of the struts can have atraumatic edges.
[0054] The disruptor element 371 can be made of nitinol braid, tubing, stainless steel, and / or any other biocompatible material. In some embodiments, the mechanical disruptor assembly 370 can include several features that are generally similar or identical to those of the clot treatment device described in detail in U.S. Patent Application No. 17 / 072,909, filed on October 16, 2020, and titled "SYSTEMS, DEVICES, AND METHODS FOR TREATING VASCULAR OCCLUSIONS", which is hereby incorporated by reference in its entirety.
[0055] Figure 3D is a side view of the handle 380 of the mechanical disruptor assembly 370 according to an embodiment of the present technology. Refer to Figures 3A to 3D, the first elongate shaft 373 and the second elongate shaft 375 (e.g., their proximal portions) can be operatively coupled to the handle 380. The handle 380 can include a first actuator 382 coupled to one of the first elongate shaft 373 or the second elongate shaft 375 and can be actuated to translate the first elongate shaft 373 and the second elongate shaft 375 relative to each other. For example, the first actuator 382 can be coupled to the second elongate shaft 375 such that (i) movement of the first actuator 382 in the proximal direction along the axis L causes the second elongate shaft 375 to retract proximally relative to the first elongate shaft 373, and (ii) movement of the first actuator 382 in the distal direction along the axis L causes the second elongate shaft 375 to advance distally relative to the first elongate shaft 373. Movement of the first actuator 382 can cause the disruptor element 371 to move between a compressed position, a partially expanded position, and an expanded position. For example, when the disruptor element is in the compressed position ( Figure 3A ), the first actuator 382 can slide (e.g., proximally) to move the second elongate shaft 375 proximally to move the distal portion 374 of the disruptor element 371 proximally toward the proximal portion 372 of the disruptor element 371 to radially expand the disruptor element to the partially expanded position ( Figure 3B ), and expand to the expanded position by further actuation ( Figure 3C ). In other embodiments, as a supplement or alternative to being actively expanded via, for example, the handle 380, the disruptor element 371 can be configured to expand passively (e.g., self-expand) within the cavity.
[0056] In other embodiments, the actuator 382 can have one or more locking positions within the handle 380 to determine the diameter of the disruptor element 371. Thus, the disruptor element can have a controllable diameter that can be gradually increased and manipulated to piecemeal disassemble septa and / or other substances within the body cavity until the diameter of the disruptor element 371 reaches the wall of the cavity. In some embodiments, the handle 380 further includes a second actuator 384 (e.g., a rotatable knob) operatively coupled to the first elongate shaft 373 and / or the second elongate shaft 375. The second actuator 384 can be actuated (e.g., rotated) to rotate the disruptor element 371 to further break down substances within the cavity, such as substances attached to the wall of the cavity. If desired, the mechanical disruptor assembly 370 can be laterally translated by the user (e.g., via movement of the handle 380) and can be delivered via a guidewire or through the inner lumen 111 of the catheter assembly 110 without a guidewire.
[0057] Figure 4is a flow chart of a process or method 480 for treating a patient's body cavity using system 100 according to an embodiment of the present technology. The body cavity can be an abdominal abscess, empyema, (e.g., complicated) pleural effusion, and / or another cavity containing unwanted substances / contents. Although, for illustration, some features of method 480 are described in the context of the embodiment shown in Figures 1A to 3D those skilled in the art will readily understand that method 480 can be performed using other suitable systems and / or devices described herein. Figures 5A to 5E is a side cross-sectional view of the distal portion of catheter assembly 110 during different stages of method 480 according to an embodiment of the present technology.
[0058] At block 481, method 480 can include percutaneously inserting catheter assembly 110 of system 100 into a patient such that the distal portion of catheter assembly 110 is positioned within the cavity to be treated. For example, Figure 5A shows catheter assembly 110 inserted through the patient's skin 591 and into a body cavity 592 containing a substance or contents 593 positioned therein such that distal opening 119 and aperture 118 are positioned within cavity 592. The substance 593 can include pus (e.g., purulent fluid) that may be thick and viscous, necrotic debris, blood clots, intestinal contents, septated cavities, etc. The substance 593 can substantially fill cavity 592, as Figure 5A shown, or can partially fill cavity 592. In some embodiments, catheter assembly 110 is inserted into the abdomen or into an intercostal space of the patient adjacent to cavity 592 via, for example, the Seldinger technique, the Trocar technique, and / or another catheter insertion technique. In some aspects of the present technology, catheter assembly 110 can have a relatively short length M ( Figure 1A ) because catheter assembly 110 is designed to be inserted into the skin 591 of the patient adjacent to cavity 592.
[0059] At block 482, method 480 can include aspirating the substance from the cavity through the inner lumen 111 of catheter assembly 110. For example, as described in detail above with reference to Figure 2A and Figure 2B syringe 242 can be actuated (e.g., plunger 244 can be pulled) to aspirate inner lumen 111. During aspiration, aspiration flow control assembly 245 is configured to permit fluid to flow from inner lumen 111 to syringe 242 while preventing fluid from waste reservoir 260 from flowing to syringe 242. Figure 5BThe catheter assembly 110 during aspiration is shown with a portion 594 of the substance 593 being pulled proximally and through the inner lumen 111 of the inner elongate member 112 by the suction force indicated by arrow A from the distal opening 119. The portion 594 of the substance 593 can be pulled completely through the inner lumen 111, through the first conduit assembly 120, through the aspiration and flow control assembly 245, and into the barrel 243 of the syringe 242, where the substance is collected. In some aspects of the present technology, the substance 593 does not enter or substantially does not enter the outer lumen 117 of the outer elongate member 114 during aspiration because (i) the aperture 118 is in a different plane than the distal opening 119 (e.g., in an orthogonal plane), and (ii) only the inner lumen 111 is aspirated, such that clogging of the aperture 118 is inhibited or even prevented.
[0060] At block 483, the method 480 can include passing a flushing fluid from the flushing reservoir 262 through the outer lumen 117 of the catheter assembly 110 and out the aperture 118 into the cavity to flush the cavity. For example, as described above with reference to Figure 2A and Figure 2B in detail, the flushing fluid can be primed into the syringe 252 by pulling out the plunger 254 (e.g., while pulling out the plunger 244 of the syringe 242 to aspirate the inner lumen 111), and then the plunger is pushed in to drive the flushing fluid through the flushing flow control assembly 255 into the outer lumen 117. When the plunger 254 is pushed in, the flushing flow control assembly 255 permits the flushing fluid to flow into the outer lumen 117 while preventing the flushing fluid from flowing into the flushing reservoir 262. Figure 5C The catheter assembly 110 during flushing is shown with the flushing fluid 595 being driven through the outer lumen 117 and through the aperture 118 into the cavity 592 as indicated by arrow I. In some aspects of the present technology, the flushing fluid 595 does not flow through the inner lumen 111, such that any portion of the substance 593 remaining in the inner lumen 111 after aspiration is not reintroduced into the cavity 592. The flushing fluid 595 can leave the aperture 118 as a jet that mechanically disrupts (e.g., breaks down) the substance 593 within the cavity 592. As described above in detail, the location, size, shape, and / or orientation of the aperture 118 can be selected to provide a desired jet pattern for disrupting the substance 593. The flushing fluid 595 can also have a lower viscosity than the substance 593 within the cavity 592, such that after flushing, the mixture of the flushing fluid 595 and the substance 593 within the cavity 592 has a lower viscosity that can be more easily aspirated during a subsequent aspiration operation. For example, Figure 5D shows the catheter assembly 110 after flushing when the resulting mixed portion 596 of the substance 593 and the flushing fluid 595 ( Figure 5C ) has a lower viscosity than the substance 593.
[0061] After flushing at block 483, method 480 may return to block 482 to aspirate the lumen again, and then proceed again to block 483 to flush the lumen. Aspiration and flushing may be performed multiple times as needed to sufficiently remove the substance from the lumen. Optionally, at block 484, method 480 may include mechanically disrupting (e.g., clearing) the substance in the lumen with a mechanical element (such as disruptor element 371) inserted through the inner lumen 111. Figure 5E For example, a catheter assembly 110 is shown after the disruptor element 371 (schematically shown in Figure 5E ) has been inserted through the inner lumen 111 of the inner elongate member 112 into the lumen 592 and after the disruptor element 371 has been expanded. The disruptor element 371 may rotate (e.g., about a first elongate axis 373) and / or translate (e.g., proximally and / or distally) within the lumen 592 as indicated by arrow R to mechanically disrupt any remaining substance of substance 593 after aspiration and flushing (blocks 482 and 483). In some embodiments, the disruptor element 371 may be actuated to mechanically disrupt some or all of the substance that remains attached to the wall 597 of the lumen 592 after aspiration and flushing.
[0062] In other embodiments, the substance in the lumen may be mechanically disrupted (blocks 482 and 483) prior to aspiration and flushing. That is, for example, the disruptor element 371 may be inserted through the inner lumen 111 and into the lumen 592 and rotated and / or translated within the lumen 592 to initially mechanically disrupt and / or break down the substance 593. In some aspects of the present technique, mechanically disrupting the substance 593 prior to aspiration and flushing may make the aspiration and flushing more effective.
[0063] At block 485, method 480 may include maintaining the catheter assembly 110 in the lumen to provide residual drainage of the substance from the lumen. The catheter assembly 110 may be maintained in the lumen for hours, days, or weeks to provide residual drainage.
[0064] At block 486, method 480 may include removing the catheter assembly 110 from the patient's body after the substance has been sufficiently removed from the lumen. At block 487, method 480 may optionally include percutaneously inserting a separate drainage catheter into the lumen to provide (further) residual drainage. In some aspects of the present technique, the drainage catheter may be of a smaller size (e.g., for increased patient comfort), may be configured to connect to an existing drainage waste bag, and / or may be of a type familiar to the operator (e.g., hospital staff). In such embodiments, system 100 may be used to perform an initial debridement, drainage, and flushing of the contents of the lumen (blocks 482 to 484), and the separate drainage catheter may be a standard commercial drainage piece that is inserted (at block 486) upon removal of system 100 during the same procedure to allow drainage of any remaining accumulation over the next few days.
[0065] Figure 6 is a side view of an aspiration and irrigation system 600 ("system 600") according to an additional embodiment of the present technology. System 600 may include the same Figures 1A to 5E Some features of the system 100 described in detail are at least generally similar in structure and function or are identical in structure and function and can operate in a generally similar or identical manner to the system 100. For example, in the illustrated embodiment, the system 600 includes a catheter assembly 610 that is fluidly coupled to (i) a valve 602 and (ii) a tubing assembly 620 via a connector or side port 604.
[0066] In the illustrated embodiment, the catheter assembly 610 defines a single lumen that can be used to provide both suction and irrigation. That is, the catheter assembly 610 may include only a single elongated member 614 (e.g., a sheath, a catheter, a shaft) extending distally from the valve 602 and the connector 604 and defining a lumen. The lumen may terminate at a distal opening 619 (e.g., a suction and irrigation opening). The elongated member 614 may have a size between about 6 French units and 30 French units, such as a size of 6 French units, 8 French units, 12 French units, 16 French units, 20 French units, 24 French units, 26 French units, or 30 French units. The lumen of the elongated member 614 is fluidly connected to (i) the valve 602 and (ii) the tubing assembly 620 via the connector 604. The valve 602 may be as described above with reference to Figures 1A to 1C An actuated access valve is described in detail, which is configured to maintain fluid control by inhibiting or preventing fluid from flowing through the valve 602 in a proximal direction when various components (such as delivery sheaths, pull members, guidewires, interventional devices, mechanical disruptor assemblies, other aspiration catheters, etc.) are inserted through the valve 602 to be delivered to a treatment site in a body cavity through the slender member 614 during a body cavity treatment procedure. In some embodiments, the lumen of the slender member 614 has a constant or substantially constant diameter extending from the distal opening 619 to the valve 602. That is, for example, the slender member 614 does not have a tapered or reduced diameter portion at its distal end portion or elsewhere along the length of the slender member 614. In some aspects of the present technology, this can maximize the aspiration flow rate through the lumen of the slender member 614.
[0067] The conduit assembly 620 can fluidly couple the lumen of the elongate member 614 to a pressure source assembly 640 and / or a flushing assembly (not shown). For example, in the illustrated embodiment, the conduit assembly 620 includes one or more conduit segments 622 (individually labeled as a first conduit segment 622a and a second conduit segment 622b), at least one fluid control device 624 (e.g., a valve, a stopcock), and at least one connector 626 (e.g., a Tuomi tip connector, a quick-release connector) for fluidly coupling the conduit assembly 620 to the pressure source assembly 640, the flushing assembly, and / or other suitable components.
[0068] The pressure source assembly 640 can include a pressure source 642 such as a syringe 642 having a barrel 643 and a plunger 644 slidable through the barrel 643, and a suction flow control assembly 645 fluidly coupled to the barrel 643 of the syringe 642. In some embodiments, the syringe 642 includes a locking mechanism 641 configured to selectively lock the plunger 644 relative to the barrel 643 (e.g., in the retracted position). Thus, the syringe 642 can be an automatically locking syringe and can include some features that are at least generally similar or identical in structure and function to those of the automatically locking syringe disclosed in U.S. Patent Application No. 17 / 396,426, filed Aug. 6, 2021, and titled “AUTOMATICALLY-LOCKING VACUUM SYRINGES, AND ASSOCIATED SYSTEMS AND METHODS,” which is incorporated herein by reference in its entirety.
[0069] The suction flow control assembly 645 can include a body 650 having (i) a first connector 646 (partially obscured in Figure 6 ), which is configured to be coupled to the connector 626 of the conduit assembly 620; (ii) a second connector 647, which is configured to be coupled to the syringe 642 (e.g., to the tip of the syringe); and (iii) a third connector 648, which is configured to be coupled to a waste reservoir 660 and more particularly to at least one tube 661 of the waste reservoir 660, the at least one tube of the waste reservoir being fluidly coupled to a waste collection bag 662 or other fluid reservoir of the waste reservoir 660. The body 650 can define one or more lumens fluidly coupling the first connector 646 to the third connector 648. In the illustrated embodiment, the suction flow control assembly 645 also includes a first one-way valve 651 in the flow path between the first connector 646 and the second connector 647 (in Figure 6is schematically shown) and a second one-way valve 652 in the flow path between the second connector 647 and the third connector 648 (in Figure 6 is schematically shown). The first one-way valve 651 is positioned to permit fluid to flow from the conduit assembly 620 and the lumen of the elongate member 614 through the aspiration flow control assembly 645 to the barrel 643 of the syringe 642 (e.g., from the first connector 646 to and through the second connector 647), while inhibiting fluid flow from the syringe 642 to the conduit assembly 620 (e.g., from the second connector 647 to and through the first connector 646). The second one-way valve 652 is positioned to permit fluid to flow from the barrel 643 of the syringe 642 through the aspiration flow control assembly 645 to the waste reservoir 660 (e.g., from the second connector 647 to and through the third connector 648), while inhibiting fluid flow from the waste reservoir 660 to the syringe 642 (e.g., from the third connector 648 to and through the second connector 647).
[0070] Accordingly, pulling the plunger 644 through the barrel 643 creates a negative pressure in the barrel 643 that draws fluid through the distal opening 619 and the lumen of the elongate member 614, through the conduit assembly 620, through the aspiration flow control assembly 645 (e.g., through the first connector 646, the first one-way valve 651, and the second connector 647) and into the barrel 643 of the syringe 642. During the pulling of the plunger 644, the second one-way valve 652 inhibits (e.g., prevents) fluid from flowing backward from the waste reservoir 660 into the barrel 643 of the syringe 642. Conversely, pushing the plunger 644 through the barrel 643 creates a positive pressure in the barrel 643 that pushes fluid from the barrel 643 through the aspiration flow control assembly 645 (e.g., through the second connector 647, the second one-way valve 652, and the third connector 648) and into the waste reservoir 660 (e.g., through the tube 661 and into the collection bag 662). During the pushing of the plunger 644, the first one-way valve 651 inhibits (e.g., prevents) fluid from flowing from the barrel 643 into the conduit assembly 620 and the lumen of the elongate member 614.
[0071] In some embodiments, the pressure source assembly 640 can be disconnected from the connector 626 of the conduit assembly 620 (e.g., where the fluid control device 624 is in the closed position), and a flushing assembly can be coupled to the connector 626 to fluidly couple the flushing assembly to the lumen of the elongate member 614. In some embodiments, the flushing assembly can include a syringe or other pressure source and a reservoir of flushing fluid (e.g., as described above with reference to Figure 2A and Figure 2B(described in detail). The pressure source can be activated (e.g., the plunger of the syringe can be pushed in) to drive the flushing fluid through the conduit assembly 620, through the lumen of the elongate member 614, and out of the distal opening 619 of the elongate member 614. In some embodiments, the flushing assembly can alternatively or additionally be coupled to a port 625 of the fluid control device 624, which provides a fluid connection to the conduit assembly 620 and the lumen of the elongate member 614. In such embodiments, the pressure source of the flushing assembly can be activated to drive the flushing fluid through the port 625, through the conduit assembly 620, through the lumen of the elongate member 614, and out of the distal opening 619 of the elongate member 614.
[0072] In operation, the catheter assembly 610 can be introduced into a patient through a percutaneous opening (e.g., an opening in the abdomen, an opening in an intercostal space) and advanced such that the distal portion of the catheter assembly 610 (e.g., the distal opening 619 of the elongate member 614) is positioned within and / or near a cavity within the patient's body. The pressure source assembly 640 can be coupled to the conduit assembly 620, and the fluid control device 624 can be opened to fluidly connect the pressure source assembly 620 to the lumen of the elongate member 614. Then, the plunger 644 of the syringe 642 can be pulled out to withdraw fluid from the lumen of the elongate member 614 to aspirate a substance from the cavity into the barrel 643. Then, the plunger 644 can be pushed in to drive the substance from the barrel 643 into the collection bag 662. In some embodiments, the plunger 644 can be repeatedly pulled out and then pushed in (e.g., pumped) to aspirate the cavity and discharge the aspirated substance into the collection bag 662. In some aspects of the present technique, the collection bag 662 provides a sealed container for the aspirated substance, which makes the procedure cleaner by reducing mess, odor, exposure to infected substances, etc. In some embodiments, the fluid control device 624 can be closed during the pulling out of the plunger 644 such that a vacuum is created (e.g., pre-charged) within the barrel 643 of the syringe 642. The fluid control device 624 can then be opened to apply a vacuum to the lumen of the elongate member 614 and create a suction / aspiration pulse through the lumen to aspirate the substance within the cavity.
[0073] At any point during the procedure, the fluid control device 624 may be closed and the pressure source assembly 640 may be disconnected from the conduit assembly 620. The flush assembly may then be coupled to the conduit assembly 620, the fluid control device 624 opened, and the flush assembly activated to drive flush fluid into the lumen of the elongate member 614 and out the distal opening 619 into the patient's lumen. Multiple flush passes / cycles may be performed. Alternatively or additionally, the pressure source assembly 640 may remain coupled to the conduit assembly 620 and the flush assembly may be coupled to port 625 to provide flushing through the lumen of the elongate member 614. Flushing and aspiration may be provided in any order and repeated as needed, such as aspiration then flushing, flushing then aspiration, one or more aspiration cycles followed by one or more flushing cycles, one or more flushing cycles followed by one or more aspiration cycles, etc.
[0074] In some embodiments, the distal portion of the elongate member 614 may be bendable to facilitate placement and positioning within the patient's lumen. Figure 7A For example is a side view of the catheter assembly 610 according to an additional embodiment of the present technique. In the illustrated embodiment, the elongate member 614 has a distal bend portion 718 (e.g., a distal bend end portion, a distal bend region, a distal bend end portion, a bent distal tip, etc.) that is configured (e.g., heat set) to deflect away from the longitudinal axis Z of the catheter assembly 610. In the illustrated embodiment, the distal bend portion 718 has a generally curved shape and may be bent away from the longitudinal axis Z by an angle A between about 30 degrees and 90 degrees (e.g., about 80 degrees), between about 165 degrees and 195 degrees (e.g., about 180 degrees), or greater than 195 degrees (e.g., between about 250 degrees and 290 degrees, about 270 degrees). Thus, the distal bend portion 718 may have a curvature ranging from a full pigtail shape to a small angle. The curvature of the distal bend portion 718 offsets the distal opening 619 from the longitudinal axis Z. During a procedure to treat a patient's lumen, the elongate member 614 may be twisted (e.g., rotated) to control the position of the distal opening 619 within the lumen to provide directional aspiration and / or flushing.
[0075] In some embodiments, the distal bend portion 718 may be in (i) a relaxed position where the distal bend portion 718 has Figure 7A the illustrated curved shape and (ii) a constrained position where the distal bend portion 718 is more closely aligned with the longitudinal axis Z (e.g., where the bend angle A is reduced). Figure 7BFIG. 0 is a side view of a catheter assembly 610 according to an embodiment of the present technique, where a dilator 708 is inserted through a valve 602 and through the lumen of an elongate member 614. In the illustrated embodiment, the dilator 708 includes a proximal coupling portion 709 that is fixed to and / or mates with a corresponding portion of the valve 602. The dilator 708 extends completely through the lumen of the elongate member 614 and extends out of the distal opening 619. When inserted through the lumen of the elongate member 614, the dilator 708 can constrain the distal bend portion 718 as shown in Figure 7B to reduce the bend angle A ( Figure 7A ), and align the distal bend portion 718 more closely with the longitudinal axis Z ( Figure 7A ). Alternatively, a guide wire (not shown) can constrain the distal bend portion 718 to reduce the bend angle A ( Figure 7A ), and align the distal bend portion 718 more closely with the longitudinal axis Z ( Figure 7A ). In some embodiments, the dilator 708 and / or the valve 702 can be of the type disclosed in U.S. Patent Application No. 18 / 156,944, filed on January 19, 2023, and titled "CLOT TREATMENT SYSTEMS WITH DILATOR LOCKING MECHANISMS, AND ASSOCIATED DEVICES AND METHODS", which is hereby incorporated by reference in its entirety.
[0076] Reference Figure 7A and Figure 7B , the distal bend portion 718 can be formed using a heat setting process or other suitable process to have Figure 7AThe exemplified curved shape or another curved shape (e.g., a full pigtail shape, a Tiger curve shape, a Jacky curve shape, an Amplatz left shape, an LCB shape, an RCB shape, a Judkins left shape, a Judkins right shape, a multipurpose A2 shape, an IM shape, a 3D LIMA shape, an IM VB-1 shape, etc.). For example, as is known in the field of thermally setting shape memory structures, a fixture, mandrel, or mold can be used to hold the distal curved portion 718 in its desired shape, and then the distal curved portion 718 can be subjected to an appropriate heat treatment such that the shape memory material (e.g., metal, nitinol, steel) used to form the elongate member 614 (e.g., a braid, a coil, etc.) assumes the outer contour of the mandrel or mold or is otherwise shaped according to the outer contour of the mandrel or mold. The thermal setting process can be carried out in an oven or a fluidized bed, as is well known. Thus, the thermal setting process can impart a desired shape, geometry, bend, and / or curvature in one or more superelastic and / or shape memory materials used to form the elongate member 614. Thus, the distal curved portion 718 can be radially constrained without plastic deformation, as Figure 7B shown, and will self-expand to the Figure 7A exemplified position upon release of the radial constraint. In some embodiments, the distal curved portion 718 and / or the elongate member 614 can include some features that are at least substantially similar or identical in structure and function to those of the catheter disclosed in U.S. Patent Application Publication No. 17 / 529,018, filed on November 17, 2021, and titled "CATHETERS HAVING SHAPED DISTAL PORTIONS, AND ASSOCIATED SYSTEMS AND METHODS", the entire disclosure of which is incorporated herein by reference.
[0077] In some embodiments, the elongate member 614 can have one or more holes formed at and / or proximal to the distal curved portion 718. Figure 8A and Figure 8B is an enlarged side view of the distal portion of the elongate member 614 of the catheter assembly 610 according to an embodiment of the present technology. The elongate member 614 has a Figure 8A first size (e.g., 24 French units) in Figure 8B and a Figure 8A second size (e.g., 16 French units) in Figure 8B, the elongate member 614 includes / defines one or more (e.g., a plurality of) apertures 890 (e.g., holes, side holes) that are fluidly coupled to the lumen of the elongate member 614. In the illustrated embodiment, the apertures 890 may be circumferentially aligned relative to the longitudinal axis Z ( Figure 6 ) and spaced apart from each other relative to the longitudinal axis Z proximal to the distal bend portion 718. In other embodiments, some or all of the apertures 890 may be circumferentially distributed, spaced differently, formed in the distal bend portion 718 and / or other portions of the elongate member 614, etc. Referring Figure 6 , Figure 8A and Figure 8B , when the lumen of the elongate member 614 is aspirated via the aspiration source assembly 620, aspiration pressure may be applied through the apertures 890 and / or through the distal opening 619. Similarly, when the lumen of the elongate member 614 is flushed via the flushing assembly, flushing fluid may be injected through the apertures 890 and / or through the distal opening 619. In some aspects of the present technology, the apertures 890 may reduce the likelihood of blockage of the elongate member 614 and reduce the aspiration force from each of the apertures 890 and / or the distal opening 619.
[0078] Referring Figure 8A and Figure 8B , in some embodiments, the catheter assembly 610 may include a cover or other feature (not shown) that may be manipulated during a procedure to cover one or more of the apertures 890. For example, another elongate member, sheath, etc. may be advanced through the lumen of the elongate member 614 and / or through the outer surface of the elongate member 614 to cover the apertures 890. Covering the apertures 890 may increase the resulting aspiration force at the distal opening 619. The cover may include one or more apertures that are aligned with the apertures 890 of the elongate member 614 to selectively control which of the apertures 890 the resulting aspiration force should be applied through. Similarly, some or all of the cover apertures (not shown) may be circumferentially distributed and / or spaced differently on the cover. Additionally, another elongate shaft, member, sheath, etc. may be advanced distally through the lumen of the elongate member 614 and / or through the outer surface of the elongate member 614 to align the distal bend portion 718 more closely with the longitudinal axis Z ( Figure 7A ). The cover or elongate shaft may be operably coupled to a handle (not shown), where an actuator is coupled to the elongate shaft. The actuator may be manipulated to move the elongate shaft relative to the longitudinal axis Z.
[0079] Several aspects of the present technology are set forth in the following examples:
[0080] 1. A system for aspirating and flushing a body cavity, comprising:
[0081] A catheter assembly, the catheter assembly comprising—
[0082] An outer elongate member defining an outer lumen; and
[0083] An inner elongate member at least partially extending through the outer elongate member and defining an inner lumen having a distal opening, wherein a distal portion of the outer elongate member is fluidly sealed to the inner elongate member, and wherein the outer elongate member includes a hole positioned proximal to the distal portion;
[0084] A suction source fluidly coupled to the inner lumen and configured to suction the inner lumen; and
[0085] A flush source fluidly coupled to the outer lumen and configured to flow flush fluid through the outer lumen and out of the hole.
[0086] 2. The system according to embodiment 1, wherein the inner elongate member is coaxial with the outer elongate member.
[0087] 3. The system according to embodiment 1 or 2, wherein the suction source is a first syringe, and wherein the flush source is a second syringe.
[0088] 4. The system according to any one of embodiments 1 to 3, wherein the hole is one of a plurality of holes circumferentially positioned around the outer elongate member.
[0089] 5. The system according to any one of embodiments 1 to 4, further comprising a suction flow control assembly fluidly coupled between the suction source and the inner lumen, wherein the suction flow control is also fluidly coupled to a waste reservoir, and wherein the suction flow control assembly is configured to—
[0090] When actuating the suction source in a first manner, allow fluid to flow from the inner lumen to the suction source while preventing fluid from flowing from the waste reservoir to the suction source, and
[0091] When actuating the suction source in a second manner different from the first manner, allow fluid to flow from the suction source to the waste reservoir while preventing fluid from flowing from the suction source to the inner lumen.
[0092] 6. The system according to embodiment 5, wherein the suction source is a syringe having a plunger, wherein the first manner is pulling of the plunger, and wherein the second manner is pushing of the plunger.
[0093] 7. The system according to any one of embodiments 1 to 6 further includes a flush flow control assembly fluidly coupled between the flush source and the outer lumen, wherein the flush flow control assembly is also fluidly coupled to a flush reservoir configured to hold flush fluid, and wherein the flush flow control assembly is configured to—
[0094] when actuating the flush source in a first manner, allow the flush fluid to flow from the flush reservoir to the flush source while preventing fluid from flowing from the outer lumen to the flush source, and
[0095] when actuating the flush source in a second manner different from the first manner, allow the flush fluid to flow from the flush source into the outer lumen while preventing the flush fluid from flowing from the flush source into the flush reservoir.
[0096] 8. The system according to embodiment 7, wherein the flush source is a syringe having a plunger, wherein the first manner is pulling of the plunger, and wherein the second manner is pushing of the plunger.
[0097] 9. The system according to any one of embodiments 1 to 8 further includes:
[0098] a suction flow control assembly fluidly coupled between the suction source and the inner lumen, wherein the suction flow control assembly is also fluidly coupled to a waste reservoir, and wherein the suction flow control assembly is configured to—
[0099] when actuating the suction source in a first manner, allow fluid to flow from the inner lumen to the suction source while preventing fluid from flowing from the waste reservoir to the suction source, and
[0100] when actuating the suction source in a second manner different from the first manner, allow fluid to flow from the suction source to the waste reservoir while preventing fluid from flowing from the suction source to the inner lumen; and
[0101] a flush flow control assembly fluidly coupled between the flush source and the outer lumen, wherein the flush flow control assembly is also fluidly coupled to a flush reservoir configured to hold flush fluid, and wherein the flush flow control assembly is configured to—
[0102] when actuating the flush source in a third manner, allow the flush fluid to flow from the flush reservoir to the flush source while preventing fluid from flowing from the outer lumen to the flush source, and
[0103] When actuating the flushing source in a fourth manner different from the third manner, the flushing fluid is permitted to flow from the flushing source into the outer lumen while preventing the flushing fluid from flowing from the flushing source into the flushing reservoir.
[0104] 10. The system according to embodiment 9, wherein the suction source is a first syringe having a first plunger, wherein the first manner is the pulling out of the first plunger, wherein the second manner is the pushing in of the second plunger, wherein the flushing source is a second syringe having a second plunger, wherein the third manner is the pulling out of the second plunger, and wherein the fourth manner is the pushing in of the second plunger.
[0105] 11. The system according to embodiment 10, wherein the first plunger and the second plunger are mechanically coupled and configured to move together during pulling out and pushing in.
[0106] 12. The system according to any one of embodiments 1 to 11, further comprising:
[0107] A suction flow control assembly fluidly coupled between the suction source and the inner lumen, wherein the suction flow control assembly includes:
[0108] A first connector configured to be fluidly coupled to the inner lumen;
[0109] A second connector configured to be fluidly coupled to the waste reservoir;
[0110] A first check valve positioned between the first connector and the suction source, wherein the first check valve is positioned to (a) permit fluid to flow from the inner lumen through the first connector to the suction source, and (b) inhibit fluid from flowing from the suction source through the first connector to the inner lumen; and
[0111] A second check valve positioned between the second connector and the suction source, wherein the second check valve is positioned to (a) permit fluid to flow from the suction source through the second connector to the waste reservoir, and (b) inhibit fluid from flowing from the waste reservoir through the second connector to the suction source.
[0112] 13. The system according to embodiment 12, wherein —
[0113] The suction source includes a syringe having a plunger;
[0114] The pulling out of the plunger is configured to suction a substance from the cavity through the inner lumen;
[0115] During the pulling of the plunger, the first one-way valve is positioned to allow the substance to flow into the syringe through the first connector, and the second one-way valve is positioned to inhibit flow from the waste reservoir to the syringe;
[0116] The pushing of the plunger is configured to cause the aspirated substance to flow from the syringe to the waste reservoir; and
[0117] During the pushing of the plunger, the first one-way valve is positioned to inhibit the aspirated substance from flowing into the inner lumen through the first connector, and the second one-way valve is positioned to allow the aspirated substance to flow from the syringe through the second connector into the waste reservoir.
[0118] 14. The system according to any one of embodiments 1 to 13, further comprising:
[0119] A flush flow control assembly fluidly coupled between the suction source and the outer lumen, wherein the suction flow control assembly comprises:
[0120] A first connector configured to be fluidly coupled to the outer lumen;
[0121] A second connector configured to be fluidly coupled to a flush reservoir;
[0122] A first one-way valve positioned between the first connector and the flush source, wherein the first one-way valve is positioned to (a) allow fluid to flow from the flush source through the first connector to the outer lumen, and (b) inhibit fluid from flowing from the inner lumen through the first connector to the flush source; and
[0123] A second one-way valve positioned between the second connector and the flush source, wherein the second one-way valve is positioned to (a) allow fluid to flow from the flush reservoir through the second connector to the flush source, and (b) inhibit fluid from flowing from the flush source through the second connector to the flush reservoir.
[0124] 15. The system according to embodiment 14, wherein -
[0125] The flush source includes a syringe having a plunger;
[0126] The pulling of the plunger is configured to at least partially fill the syringe with flush fluid from the flush reservoir;
[0127] During the retraction of the plunger, the first one-way valve is positioned to inhibit the inflow of fluid into the syringe through the first connector, and the second one-way valve is positioned to permit the flushing fluid to flow from the flushing reservoir to the syringe;
[0128] The pushing of the plunger is configured to cause the flushing fluid to flow from the syringe to the outer lumen; and
[0129] During the pushing of the plunger, the first one-way valve is positioned to permit the flushing fluid to flow into the outer lumen through the first connector, and the second one-way valve is positioned to inhibit the flushing fluid from flowing from the syringe into the flushing reservoir through the second connector.
[0130] 16. The system according to any one of embodiments 1 to 15, further comprising:
[0131] A suction flow control assembly fluidly coupled between the suction source and the inner lumen, wherein the suction flow control assembly includes:
[0132] A first connector configured to be fluidly coupled to the inner lumen;
[0133] A second connector configured to be fluidly coupled to a waste reservoir;
[0134] A first one-way valve positioned between the first connector and the suction source, wherein the first one-way valve is positioned to (a) permit fluid to flow from the inner lumen through the first connector to the suction source, and (b) inhibit fluid from flowing from the suction source through the first connector to the inner lumen; and
[0135] A second one-way valve positioned between the second connector and the suction source, wherein the second one-way valve is positioned to (a) permit fluid to flow from the suction source through the second connector to the waste reservoir, and (b) inhibit fluid from flowing from the waste reservoir through the second connector to the suction source; and
[0136] A flushing flow control assembly fluidly coupled between the suction source and the outer lumen, wherein the suction flow control assembly includes:
[0137] A third connector configured to be fluidly coupled to the outer lumen;
[0138] A fourth connector configured to be fluidly coupled to a flushing reservoir;
[0139] A third one-way valve positioned between the third connector and the flushing source, wherein the third one-way valve is positioned to (a) permit fluid to flow from the flushing source through the third connector to the outer lumen, and (b) inhibit fluid from flowing from the inner lumen through the third connector to the flushing source; and
[0140] A fourth one-way valve positioned between the fourth connector and the flushing source, wherein the fourth one-way valve is positioned to (a) permit fluid to flow from the flushing reservoir through the fourth connector to the flushing source, and (b) inhibit fluid from flowing from the flushing source through the fourth connector to the flushing reservoir.
[0141] 17. The system according to embodiment 16, wherein—
[0142] The suction source is a first syringe having a first plunger;
[0143] Pulling out of the first plunger is configured to suction a substance from the chamber through the inner lumen;
[0144] During pulling out of the first plunger, the first one-way valve is positioned to permit the substance to flow through the first connector into the first syringe, and the second one-way valve is positioned to inhibit flow from the waste reservoir to the first syringe;
[0145] Pushing in of the first plunger is configured to cause the suctioned substance to flow from the first syringe to the waste reservoir; and
[0146] During pushing in of the first plunger, the first one-way valve is positioned to inhibit the suctioned substance from flowing through the first connector into the inner lumen, and the second one-way valve is positioned to permit the suctioned substance to flow from the first syringe through the second connector into the waste reservoir;
[0147] The flushing source is a second syringe having a second plunger;
[0148] Pulling out of the second plunger is configured to at least partially fill the second syringe with flushing fluid from the flushing reservoir;
[0149] During pulling out of the second plunger, the third one-way valve is positioned to inhibit flow into the second syringe through the third connector, and the fourth one-way valve is positioned to permit the flushing fluid to flow from the flushing reservoir to the second syringe;
[0150] Pushing in of the second plunger is configured to cause the flushing fluid to flow from the second syringe to the outer lumen; and
[0151] During the pushing of the second plunger, the third one-way valve is positioned to permit the flushing fluid to flow through the third connector into the outer lumen, and the fourth one-way valve is positioned to inhibit the flushing fluid from flowing from the second syringe through the fourth connector into the flushing reservoir.
[0152] 18. The system according to embodiment 17, wherein the first plunger and the second plunger are mechanically coupled and configured to move together.
[0153] 19. The system according to any one of embodiments 1 to 18, wherein the inner elongate member is a reinforcement catheter and wherein the outer elongate member is a tube formed of a plastic material.
[0154] 20. A method of treating a substance in a body cavity of a patient, the method comprising:
[0155] percutaneously inserting a catheter assembly into the patient such that a distal portion of the catheter assembly is within the cavity;
[0156] aspirating the substance from the cavity through an inner lumen of the catheter assembly; and
[0157] causing a flushing fluid to flow through an outer lumen of the catheter assembly, out of outer holes in the catheter assembly, and into the cavity to flush the cavity, wherein the outer lumen is coaxial with the inner lumen.
[0158] 21. The method according to embodiment 20, the method further comprising:
[0159] inserting a mechanical disruptor element through the inner lumen;
[0160] expanding the mechanical disruptor element within the cavity; and
[0161] engaging the mechanical disruptor element with the substance within the cavity to mechanically disrupt the substance.
[0162] 22. The method according to embodiment 20 or embodiment 21, wherein aspirating the substance from the cavity comprises activating a syringe fluidly coupled to the inner lumen.
[0163] 23. The method according to any one of embodiments 20 to 22, wherein causing the flushing fluid to flow through the outer lumen comprises activating a syringe fluidly coupled to the outer lumen.
[0164] 24. The method according to any one of embodiments 20 to 23, wherein aspirating the substance from the cavity comprises pulling a plunger of a suction syringe fluidly coupled to the inner lumen, and wherein causing the flushing fluid to flow through the outer lumen comprises pushing a plunger of a flushing syringe fluidly coupled to the outer lumen.
[0165] 25. The method according to embodiment 24, wherein the method further comprises:
[0166] Pulling out the plunger of the flushing syringe to draw the flushing fluid into the flushing syringe; and
[0167] Pushing in the plunger of the aspiration syringe to discharge the aspirated substance from the aspiration syringe.
[0168] 26. The method according to embodiment 25, wherein the method further comprises:
[0169] Simultaneously pulling out the plunger of the aspiration syringe to aspirate the substance from the cavity and pulling out the plunger of the flushing syringe to draw the flushing fluid into the flushing syringe; and
[0170] Simultaneously pushing in the plunger of the aspiration syringe to discharge the aspirated substance from the aspiration syringe and pushing in the plunger of the flushing syringe to cause the flushing fluid to flow into the cavity to flush the cavity.
[0171] 27. The method according to embodiment 26, wherein the plunger of the aspiration syringe and the plunger of the flushing syringe are mechanically coupled to move together.
[0172] 28. A system for aspirating and flushing a body cavity, comprising:
[0173] A catheter assembly, the catheter assembly comprising—
[0174] An outer elongated member that defines an outer lumen; and
[0175] An inner elongated member that at least partially extends through the outer elongated member and defines an inner lumen having a distal opening, wherein a distal portion of the outer elongated member is fluidly sealed to the inner elongated member, and wherein the outer elongated member includes a hole positioned proximal to the distal portion;
[0176] An aspiration syringe fluidly coupled to the inner lumen and configured to aspirate the inner lumen; and
[0177] A flushing syringe fluidly coupled to the outer lumen and configured to cause a flushing fluid to flow through the outer lumen and out of the hole.
[0178] 29. The method according to embodiment 28, wherein the aspiration syringe and the flushing syringe are mechanically coupled to be synchronously actuated.
[0179] 30. A method of processing a substance within a body cavity of a patient using the system according to any one of Embodiments 1 to 19, 28 or 29.
[0180] 31. A suction flow control assembly for use within a suction and irrigation system according to any one of Embodiments 5, 6, 9 to 13 or 16 to 18.
[0181] 32. A flush flow control assembly for use within a suction and irrigation system according to any one of Embodiments 7 to 11 or 14 to 18.
[0182] 33. A combined suction flow control assembly and flush flow control assembly for use within a suction and irrigation system according to any one of Embodiments 9 to 11 or 16 to 18.
[0183] The above detailed description of embodiments of the technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments and examples of the technology have been described above for purposes of illustration, those skilled in the relevant art will recognize that various equivalent modifications can be made within the scope of the technology. For example, although steps are given in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein can also be combined to provide other embodiments.
[0184] In accordance with the above, it should be understood that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of embodiments of the technology. Where context permits, singular or plural terms may also respectively include plural or singular terms.
[0185] In addition, unless the word "or" is explicitly limited to only indicating a single item that excludes other items in a list of two or more items, the use of "or" in such a list should be interpreted to include (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term "comprising" throughout refers to including at least the recited feature, such that any greater number of the same features and / or other types of features are not excluded. It should also be understood that specific embodiments have been described herein for purposes of illustration, but various modifications can be made without departing from the technology. Moreover, although advantages associated with certain embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to fall within the scope of the technology. Accordingly, the present disclosure and related technology may include other embodiments not explicitly shown or described herein.
Claims
1. A system for aspirating and irrigating a body cavity, comprising: a catheter assembly, the catheter assembly comprising— an outer elongate member that defines an outer lumen; and an inner elongate member that at least partially extends through the outer elongate member and defines an inner lumen having a distal opening, wherein a distal portion of the outer elongate member is fluidly sealed to the inner elongate member, and wherein the outer elongate member includes a hole positioned proximal to the distal portion; an aspiration source fluidly coupled to the inner lumen and configured to aspirate the inner lumen; and an irrigation source fluidly coupled to the outer lumen and configured to cause irrigation fluid to flow through the outer lumen and out of the hole.
2. The system of claim 1, wherein the inner elongate member is coaxial with the outer elongate member.
3. The system of claim 1, wherein the aspiration source is a first syringe, and wherein the irrigation source is a second syringe.
4. The system of claim 1, wherein the hole is one of a plurality of holes circumferentially positioned around the outer elongate member.
5. The system of any one of claims 1, further comprising an aspiration flow control assembly fluidly coupled between the aspiration source and the inner lumen, wherein the aspiration flow control is also fluidly coupled to a waste reservoir, and wherein the aspiration flow control assembly is configured to— when actuating the aspiration source in a first manner, permit fluid to flow from the inner lumen to the aspiration source while preventing fluid from flowing from the waste reservoir to the aspiration source, and when actuating the aspiration source in a second manner different from the first manner, permit fluid to flow from the aspiration source to the waste reservoir while preventing fluid from flowing from the aspiration source to the inner lumen.
6. The system of claim 5, wherein the aspiration source is a syringe having a plunger, wherein the first manner is pulling of the plunger, and wherein the second manner is pushing of the plunger.
7. The system of claim 1, further comprising an irrigation flow control assembly fluidly coupled between the irrigation source and the outer lumen, wherein the irrigation flow control assembly is also fluidly coupled to an irrigation reservoir configured to hold irrigation fluid, and wherein the irrigation flow control assembly is configured to— when actuating the irrigation source in a first manner, permit the irrigation fluid to flow from the irrigation reservoir to the irrigation source while preventing fluid from flowing from the outer lumen to the irrigation source, and when actuating the irrigation source in a second manner different from the first manner, permit the irrigation fluid to flow from the irrigation source into the outer lumen while preventing the irrigation fluid from flowing from the irrigation source into the irrigation reservoir.
8. The system of claim 7, wherein the irrigation source is a syringe having a plunger, wherein the first manner is pulling of the plunger, and wherein the second manner is pushing of the plunger.
9. The system of claim 1, further comprising: A suction flow control assembly fluidly coupled between the suction source and the inner lumen, wherein the suction flow control assembly is also fluidly coupled to a waste reservoir, and wherein the suction flow control assembly is configured to— When the suction source is actuated in a first manner, allow fluid to flow from the inner lumen to the suction source while preventing fluid from flowing from the waste reservoir to the suction source, and When the suction source is actuated in a second manner different from the first manner, allow fluid to flow from the suction source to the waste reservoir while preventing fluid from flowing from the suction source to the inner lumen; And A flush flow control assembly fluidly coupled between the flush source and the outer lumen, wherein the flush flow control assembly is also fluidly coupled to a flush reservoir configured to hold flush fluid, and wherein the flush flow control assembly is configured to— When the flush source is actuated in a third manner, allow the flush fluid to flow from the flush reservoir to the flush source while preventing fluid from flowing from the outer lumen to the flush source, and When the flush source is actuated in a fourth manner different from the third manner, allow the flush fluid to flow from the flush source into the outer lumen while preventing the flush fluid from flowing from the flush source into the flush reservoir.
10. The system according to claim 9, wherein the suction source is a first syringe having a first plunger, wherein the first manner is the pulling out of the first plunger, wherein the second manner is the pushing in of the second plunger, wherein the flush source is a second syringe having a second plunger, wherein the third manner is the pulling out of the second plunger, and wherein the fourth manner is the pushing in of the second plunger.
11. The system according to claim 10, wherein the first plunger and the second plunger are mechanically coupled and configured to move together during pulling out and pushing in.
12. The system according to claim 1, further comprising: A suction flow control assembly fluidly coupled between the suction source and the inner lumen, wherein the suction flow control assembly includes: A first connector configured to be fluidly coupled to the inner lumen; A second connector configured to be fluidly coupled to the waste reservoir; A first one-way valve positioned between the first connector and the suction source, wherein the first one-way valve is positioned to (a) allow fluid to flow from the inner lumen through the first connector to the suction source, and (b) inhibit fluid from flowing from the suction source through the first connector to the inner lumen; and A second one-way valve positioned between the second connector and the suction source, wherein the second one-way valve is positioned to (a) allow fluid to flow from the suction source through the second connector to the waste reservoir, and (b) inhibit fluid from flowing from the waste reservoir through the second connector to the suction source.
13. In the system according to claim 12, wherein— The suction source includes a syringe having a plunger; The pulling of the plunger is configured to suction a substance from the chamber through the inner lumen; During the pulling of the plunger, the first one-way valve is positioned to permit the substance to flow into the syringe through the first connector, and the second one-way valve is positioned to inhibit flow from the waste reservoir to the syringe; The pushing of the plunger is configured to cause the suctioned substance to flow from the syringe to the waste reservoir; and During the pushing of the plunger, the first one-way valve is positioned to inhibit the suctioned substance from flowing into the inner lumen through the first connector, and the second one-way valve is positioned to permit the suctioned substance to flow from the syringe through the second connector into the waste reservoir.
14. The system according to claim 1, further comprising: A flush flow control assembly fluidly coupled between the suction source and the outer lumen, wherein the suction flow control assembly includes: A first connector configured to be fluidly coupled to the outer lumen; A second connector configured to be fluidly coupled to a flush reservoir; A first one-way valve positioned between the first connector and the flush source, wherein the first one-way valve is positioned to (a) permit fluid to flow from the flush source through the first connector to the outer lumen, and (b) inhibit fluid from flowing from the inner lumen through the first connector to the flush source; and A second one-way valve positioned between the second connector and the flush source, wherein the second one-way valve is positioned to (a) permit fluid to flow from the flush reservoir through the second connector to the flush source, and (b) inhibit fluid from flowing from the flush source through the second connector to the flush reservoir.
15. The system according to claim 14, wherein— The flush source includes a syringe having a plunger; The pulling of the plunger is configured to at least partially fill the syringe with flush fluid from the flush reservoir; During the pulling of the plunger, the first one-way valve is positioned to inhibit flow into the syringe through the first connector, and the second one-way valve is positioned to permit the flush fluid to flow from the flush reservoir to the syringe; The pushing of the plunger is configured to cause the flush fluid to flow from the syringe to the outer lumen; and During the pushing of the plunger, the first one-way valve is positioned to permit the flush fluid to flow into the outer lumen through the first connector, and the second one-way valve is positioned to inhibit the flush fluid from flowing from the syringe through the second connector into the flush reservoir.
16. The system according to claim 1, further comprising: A suction flow control assembly fluidly coupled between the suction source and the inner lumen, wherein the suction flow control assembly includes: A first connector configured to be fluidly coupled to the inner lumen; A second connector configured to be fluidly coupled to a waste reservoir; A first check valve positioned between the first connector and the suction source, wherein the first check valve is positioned to (a) permit fluid to flow from the inner lumen through the first connector to the suction source, and (b) inhibit fluid from flowing from the suction source through the first connector to the inner lumen; and A second check valve positioned between the second connector and the suction source, wherein the second check valve is positioned to (a) permit fluid to flow from the suction source through the second connector to the waste reservoir, and (b) inhibit fluid from flowing from the waste reservoir through the second connector to the suction source; and A flush flow control assembly fluidly coupled between the suction source and the outer lumen, wherein the suction flow control assembly includes: A third connector configured to be fluidly coupled to the outer lumen; A fourth connector configured to be fluidly coupled to a flush reservoir; A third check valve positioned between the third connector and the flush source, wherein the third check valve is positioned to (a) permit fluid to flow from the flush source through the third connector to the outer lumen, and (b) inhibit fluid from flowing from the inner lumen through the third connector to the flush source; and A fourth check valve positioned between the fourth connector and the flush source, wherein the fourth check valve is positioned to (a) permit fluid to flow from the flush reservoir through the fourth connector to the flush source, and (b) inhibit fluid from flowing from the flush source through the fourth connector to the flush reservoir.
17. The system of claim 16, wherein— The suction source is a first syringe having a first plunger; Pulling of the first plunger is configured to aspirate a substance through the inner lumen; During pulling of the first plunger, the first check valve is positioned to permit the substance to flow through the first connector into the first syringe, and the second check valve is positioned to inhibit flow from the waste reservoir to the first syringe; Pushing of the first plunger is configured to cause the aspirated substance to flow from the first syringe to the waste reservoir; and During pushing of the first plunger, the first check valve is positioned to inhibit the aspirated substance from flowing through the first connector into the inner lumen, and the second check valve is positioned to permit the aspirated substance to flow from the first syringe through the second connector into the waste reservoir; The flush source is a second syringe having a second plunger; Pulling of the second plunger is configured to at least partially fill the second syringe with flush fluid from the flush reservoir; During the withdrawal of the second plunger, the third one-way valve is positioned to inhibit the flow of fluid into the second syringe through the third connector, and the fourth one-way valve is positioned to permit the flushing fluid to flow from the flushing reservoir to the second syringe; The pushing of the second plunger is configured to cause the flushing fluid to flow from the second syringe to the outer lumen; and During the pushing of the second plunger, the third one-way valve is positioned to permit the flushing fluid to flow into the outer lumen through the third connector, and the fourth one-way valve is positioned to inhibit the flushing fluid from flowing from the second syringe into the flushing reservoir through the fourth connector.
18. The system according to claim 17, wherein the first plunger and the second plunger are mechanically coupled and configured to move together.
19. The system according to claim 1, wherein the inner elongated member is a reinforcement catheter, and wherein the outer elongated member is a tube formed of a plastic material.
20. A method of treating a substance in a patient's body cavity, the method comprising: Percutaneously inserting a catheter assembly into the patient such that a distal portion of the catheter assembly is within the cavity; Aspirating a substance from the cavity through an inner lumen of the catheter assembly; And Causing a flushing fluid to flow through an outer lumen of the catheter assembly, out of an outer aperture in the catheter assembly, and into the cavity to flush the cavity, wherein the outer lumen is coaxial with the inner lumen.
21. The method according to claim 20, further comprising: Inserting a mechanical disruptor element through the inner lumen; Expanding the mechanical disruptor element within the cavity; And Engaging the mechanical disruptor element with the substance within the cavity to mechanically disrupt the substance.
22. The method according to claim 20, wherein aspirating the substance from the cavity comprises activating a syringe fluidly coupled to the inner lumen.
23. The method according to claim 20, wherein causing the flushing fluid to flow through the outer lumen comprises activating a syringe fluidly coupled to the outer lumen.
24. The method according to claim 20, wherein aspirating the substance from the cavity comprises pulling a plunger of a suction syringe fluidly coupled to the inner lumen, and wherein causing the flushing fluid to flow through the outer lumen comprises pushing a plunger of a flushing syringe fluidly coupled to the outer lumen.
25. The method according to claim 24, wherein the method further comprises: Pulling the plunger of the flushing syringe to draw the flushing fluid into the flushing syringe; And Pushing the plunger of the suction syringe to expel the aspirated substance from the suction syringe.
26. The method according to claim 25, wherein the method further comprises: Simultaneously pulling the plunger of the suction syringe to aspirate the substance from the cavity and pulling the plunger of the flushing syringe to draw the flushing fluid into the flushing syringe; And Simultaneously, the plunger of the aspiration syringe is pushed to discharge the aspirated substance from the aspiration syringe, and the plunger of the irrigation syringe is pushed to cause the irrigation fluid to flow into the cavity to irrigate the cavity.
27. The method according to claim 26, wherein the plunger of the aspiration syringe and the plunger of the irrigation syringe are mechanically coupled to move together.
28. A system for aspirating and irrigating a body cavity, comprising: a catheter assembly, the catheter assembly comprising— an outer elongate member that defines an outer lumen; and an inner elongate member that at least partially extends through the outer elongate member and defines an inner lumen having a distal opening, wherein a distal portion of the outer elongate member is fluidly sealed to the inner elongate member, and wherein the outer elongate member includes a hole positioned proximal to the distal portion; an aspiration syringe fluidly coupled to the inner lumen and configured to aspirate the inner lumen; and an irrigation syringe fluidly coupled to the outer lumen and configured to cause irrigation fluid to flow through the outer lumen and out of the hole.
29. The method according to claim 28, wherein the aspiration syringe and the irrigation syringe are mechanically coupled to be synchronously actuated.
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