Alternating flow intravascular catheters and related technologies

Abstract

To provide improved methods and apparatus for improved catheters and / or related technologies. [Solution] An alternating flow catheter 20 is shown, comprising an outer catheter 30, an inner catheter 40, a catheter cap 50, and one or more balloons 60. The outer catheter 30 further has one or more distal axial holes 32, one or more proximal holes 34, a fixed area 36, ​​and a check valve 38. The inner catheter 40 further has one or more distal axial holes, one or more proximal holes 44, and an alternating flow control mechanism.

Description

Technical Field

[0001] Priority Claim This application claims the priority of U.S. Provisional Patent Application No. 63 / 717,987, filed on November 8, 2024, which is hereby incorporated by reference in its entirety.

[0002] Joint Application U.S. Patent No. 9,616,203, filed August 7, 2013, entitled "Method and Device for Simultaneously Documenting and Treating Tension Pneumothorax and / or Hemothorax"; U.S. Patent No. 10 / 046,147, filed December 23, 2014, entitled "Percutaneous Channel System and Method"; U.S. Patent No. 10,814,119, filed August 27, 2018, entitled "Percutaneous Access Pathway System"; and "Systems and Methods Relating to Medical Applications of Synthetic Polymer," filed March 15, 2019. U.S. Patent No. 16 / 207,418, titled "Formulations)", U.S. Patent Application No. 11,832,833, filed October 5, 2020, titled "Percutaneous Access Pathway System", U.S. Patent Application No. 17 / 876,187, filed July 28, 2022, titled "Wound Treatment Device", U.S. Patent Application No. 18 / 448,455, filed August 11, 2023, titled "Percutaneous Access Pathway System", and "Systems and Methods Relating to Medical Applications of Inverse Thermosensitive Polymer Foam", filed October 12, 2023. U.S. Patent Application No. 18 / 485800, entitled “Formulations)”, and U.S. Patent Application No. 18 / 926, entitled “Autoinjector Assembly”, filed October 25, 2024.No. 615 is incorporated herein by reference in its entirety.

[0003] U.S. government licensing rights This invention was made with the support of the U.S. Government under Agreement N6600124C0031 for the Revite Automated Trauma Resuscitation System, granted by NAVAL INFORMATION WARFARE CENTER PACIFIC. The U.S. Government has specific rights to this invention.

[0004] This disclosure relates, in general, to alternating flow technology having improved catheter-related medical devices and / or related technologies. [Background technology]

[0005] Extracorporeal life support (ECLS) (e.g., extracorporeal membrane oxygenation [ECMO], cardiopulmonary bypass [CPB], extracorporeal cardiopulmonary resuscitation [ECPR]) has advanced dramatically over the past decade, improving the management of patients with refractory respiratory and / or heart failure in a variety of settings. While early, complex, and bulky systems were previously limited to specialized quaternary centers, technological advancements have resulted in miniaturized ECLS circuits enabling broader use in a wider range of hospital environments (e.g., intensive care units, emergency departments, military environments in theaters) and indications (e.g., eCPR, trauma, drug overdose, bridging to treatment). Dialysis technology has also seen similar advancements.

[0006] While major machinery has advanced significantly, the deployment of ECLS has continued to be hampered by the need to establish appropriate vascular access, which often involves more limited expertise or environmental constraints. The use of venous (VV) ECLS through a single dual-lumen cannula has simplified some access requirements by requiring the placement of only one catheter. However, it still requires the insertion of a very large cannula, and in most cases, advanced imaging (such as fluoroscopy or transesophageal echocardiography [TEE]) to guide and confirm the correct position of the cannula. Unfortunately, this has prevented ECLS from being more widely adopted.

[0007] In contrast, establishing standard line venous and dialysis catheter access using smaller catheters than ECLS is an essential and established skill for a wide range of advanced providers nursing critical conditions (e.g., emergency medicine, trauma specialists). These treatments are frequently used during critical resuscitation to establish rapid routes of administration for fluids, blood products, medications, and emergency dialysis. These treatments can also be performed in conjunction with point-of-care (POC) ultrasound, which is now widely available and has been shown to improve treatment success and reduce complications. POC ultrasound has a very small logistical footprint, with some handheld models currently weighing as little as 140g (0.3lbs), and rescue has been shown to be able to use this technique in out-of-hospital settings. This distinguishes POC ultrasound from TEE and fluoroscopy, which require specialized skills to deploy and have very large and cumbersome devices.

[0008] As previously mentioned, conventional techniques demonstrate that VV-ECLS is beneficial and can be performed via a single dual-lumen cannula (typically about 7.7 mm (23 Fr) to about 10.3 mm (31 Fr)) in the internal jugular vein (IJV) (e.g., the Avalon Elite Catheter by Getinge). This simplifies ECLS treatment by requiring only one cannula. However, blood flow in this circuit is directly determined by the limited and fixed drainage capacity of its catheter (most frequently its venous intake port), thus requiring a very large catheter size, which is accompanied by increased risks and therapeutic difficulties in subsequent complications and placement.

[0009] For this configuration, a single double-lumen cannula is inserted into the right intravascular vein (IJV), passed through the superior vena cava (SVC) and right atrium (RA), and inserted into the inferior vena cava (IVC). The proximal and distal ends are connected to its suction tube, simultaneously removing deoxygenated blood from the upper and lower body. Oxygenated blood from the ECLS circuit is returned through an exit port directed toward the tricuspid valve (TV). This delivery port should be positioned within the RA and ideally rotated to guide the flow across the TV to minimize recirculation. Re-aspirating bleeding into the ECLS circuit causes recirculation, significantly reducing the efficiency of VV-ECLS. As mentioned earlier, proper cannula positioning is now performed using advanced imaging to confirm the wire position at each step of the procedure, as is the positioning of the catheter at completion.

[0010] Conventional technologies also include portable ECLS systems, such as the Breethe OXY-1 System (trademark) (Abiomed®). This system has FDA 510(k) clearance for up to 6 hours of ECMO. The system consists of two modules: a pump-lung unit (PLU) and a respiratory management unit (RMU). The PLU is equipped with an integrated centrifugal pump and a hollow fiber membrane oxygenator, which consists of 30,000 polymethylpentene fibers, each with a diameter of 380 microns. The fibers are woven into a cylindrical structure surrounding the centrifugal pump, which works to draw blood from the patient through the fiber mesh and return the now-oxygenated blood to the patient. The RMU can deliver O2 directly using a dedicated tank (external gas mode) or a built-in oxygen concentrator (internal gas mode). The RMU also houses the power supply voltage and control interface. This demonstrates that while currently available hardware has limited usage time (less than 6 hours) due to the risk of thrombotic complications, ECLS systems can be miniaturized for portability.

[0011] Conventional attempts at venous drainage from IVCs have resulted in reduced performance due to the collapse of the IVC wall onto the catheter, which inhibits drainage and leads to aspiration events (i.e., "chattering").

[0012] The conventional literature generally relates to the medical field and, more specifically, discloses various additional known methods and devices related to improved catheters and / or related technologies. However, in some aspects, all are limited. [Overview of the project]

[0013] This disclosure overcomes and substantially mitigates the shortcomings of the prior art by providing improved devices and methods relating to alternating flow technology, which is generally relevant to the field of medicine and, more specifically, to improved catheters, ECLS systems, dialysis systems, and / or related technologies. In various embodiments, this disclosure covers catheter-related medical devices. In these embodiments, catheter-related medical devices are improved systems, machines, vascular catheters (e.g., intravenous catheters, peripheral catheters, central venous catheters, tunnel catheters, implanted port catheters, arterial catheters, venous catheters, dialysis catheters, ECMO catheters, ECLS catheters, CPB machines, and / or peripherally inserted central catheters), and / or related medical devices. In embodiments, improved vascular catheters and / or catheter-related medical devices enable improved flow rates and / or alternating unidirectional flow (i.e., a flow in one direction followed by a flow in the other direction, at least partially within the same lumen of the catheter) compared to the prior art. In embodiments, the device provides improved fluid-based extraction (e.g., extracting blood from peripheral veins for laboratory analysis, or extracting / removing blood during ECLS or dialysis).

[0014] In embodiments, the catheter-related medical devices disclosed herein are designed to allow alternating stages (e.g., bidirectional) of discharge and return flow through a single catheter lumen. In embodiments, this offers the advantage that maximum flow (e.g., bidirectional flow through a single catheter lumen) can be facilitated by utilizing the maximum and / or near-maximum functional cross-sectional area of ​​the lumen. In embodiments, this design increases catheter flow (e.g., up to 200%) compared to conventional dual-lumen catheters through the crucial insight that flow through one lumen is dramatically larger than flow through the same area when divided into two or more lumens (e.g., as occurs in conventional dual-lumen catheters with continuous flow, e.g., single-catheter ECLS and dialysis systems with conventional continuous and non-alternating flow). As demonstrated by the Hagen-Poiseuille formula, the volumetric flow rate (Q) is proportional to the cross-sectional area (A) of the catheter. 2 Since it is directly proportional to the square of ), the flow through a given cross-sectional area can be much larger than the sum of the flows in that area.

[0015] In embodiments, the catheter-related medical device disclosed herein provides alternating flow (e.g., a cycle of flow in one direction followed by a cycle of flow in another direction) to a patient through a single catheter and / or single catheter lumen. In embodiments, the catheter-related medical device provides ECLS to a patient, and the alternating flow is a cycle between oxygenated and deoxygenated blood through a single catheter (e.g., placed in the femoral vein) and / or single catheter tube. This is novel because all existing ECLS devices operate through a continuous flow of drainage and return to the patient through either a single dual-lumen catheter or at least two single-lumen catheters, thus teaching that they are different from the present invention. In embodiments, the catheter-related medical device provides dialysis to a patient, and the alternating flow is a cycle between blood drawn out and blood returned through a single catheter and / or single catheter lumen.

[0016] In embodiments, the catheter-related medical device comprises components used in conventional ECLS and / or dialysis systems, modified to allow continuous flow to the patient, and is modified to alternately flow one or more of the following: catheter, tube, user interface, gas mixer, pump, bubble trap, oxygen supply, heat exchanger, perfusion circuit, filter, actuator, reservoir, blood analyzer, alarm, battery, processor, control algorithm, heparin pump, sensor, dialyzer, dialysate delivery system, heparin pump, and / or ultrafiltration control system.

[0017] In embodiments, the catheter-related medical device has one or more reservoirs to allow storage of blood and / or other medical fluids discharged into the system (e.g., during its discharge phase). At least a portion of this volume is then returned to the patient during its return phase. In embodiments, this has a hard-shell reservoir. In embodiments, this has a soft-bladder reservoir. In embodiments, the system utilizes one or more sensors to determine the volume in the reservoir. In embodiments, these sensors directly or indirectly sense fluid level, pressure, displacement, flow rate, and / or weight using optical, conductive, ultrasonic, infrared, capacitive, and / or gravimetric methods to determine absolute and / or relative volume, and / or indirect estimation thereof.

[0018] In embodiments, the catheter-related medical device comprises one or more pumps for driving fluid through the system. In some embodiments, this is a single centrifugal pump, minimizing potential mismatch between the pulled and pushed fluids in the system. In some embodiments, this is two or more centrifugal pumps, maintaining flow in two or more perfusion circuits. Various embodiments have various other pumps having centrifugal, diaphragm, piston, submersible, gear, positive displacement, peristaltic, screw, lobe, axial flow, dynamic, horizontal centrifugal, reciprocating, vertical centrifugal, displacement, progressive cavity, vane, gear, reciprocating, self-priming, horizontal multistage, and / or rotational characteristics.

[0019] In embodiments, the catheter-related medical device comprises one or more perfusion circuits. In embodiments, the perfusion circuit is disposable. In embodiments, the perfusion circuit comprises two functionally connected circuit loops, namely, one circuit loop for drawing blood and / or other medical fluids from the body and storing them in a reservoir (i.e., a draining loop), and one circuit loop for drawing blood and / or other medical fluids from the reservoir and injecting them into the body (i.e., a return loop). In embodiments, the perfusion circuit is functionally configured from two connected circuit loops similar to human physiology, namely, one circuit loop for drawing blood and / or other medical fluids from the body and later returning them to the body (i.e., a system loop), and one circuit loop for drawing blood and / or other medical fluids from the system loop and sending them to an oxygen supply and / or dialyzer (i.e., a lung and / or heart loop). In embodiments, the catheter-related medical device functions as a closed-loop system, and therefore the amount of fluid discharged from or returned to the patient is approximately equal to the amount discharged or returned to the reservoir. In embodiments, the catheter-related medical device can further function as an open-loop system, and blood and / or other medical fluids and / or drugs can be added to or withdrawn from the system (for example, to provide additional blood products and / or other medical fluids to the patient via the system). In embodiments, some or all components of the perfusion circuit and / or other catheter-related medical device are coated and / or embedded with one or more beneficial substances, examples of which include heparin-conjugated coatings (e.g., CBAS / Calmeda; MAQUET Bioline), phosphorus-based "biomimetic" coatings (e.g., Physio), albumin-heparin hybrids (e.g., Bioline), NO-releasing and / or NO-catalyzed coatings, zwitter and / or hydrogel antifouling surfaces (e.g., PEG-like, SBMA), omniphobic and / or tethered liquid perfluorocarbon surfaces, and / or antimicrobial impregnated coatings (e.g., chlorexidine-silver sulfazidine).

[0020] In embodiments, the sensor(s) may include sensors that sense one or more of the following: flow rate, pressure, air and / or bubbles, oxygen saturation, oxygen, carbon dioxide, gas exchange, temperature, conductivity, hematocrit and / or hemoglobin, viscosity, clot, electrolyte, biochemical, optical and / or photometric measurement, fluid level, and / or others. In embodiments, the sensors are placed on one or more circuit loops to determine the relationships between loops in the system.

[0021] In embodiments, the system can be controlled by a user interface and / or control algorithm by setting the target reservoir volume, pump motor speed, and / or the relative closure and / or resistance of one or more loop actuators. In embodiments, system control involves applying different settings to the loop actuator(s) between different system stages (e.g., draw, return, setup, idle). In embodiments, one or more loop actuators can vary the relative resistance between tubular sections to preferentially guide flow to a desired circuit loop depending on the system stage. In embodiments, this has a complete closure of one or more tubular sections by one or more loop actuators. In embodiments, the loop actuator(s) do not completely close, but instead maintain at least minimal flow through the circuit loop to prevent and / or minimize coagulation, hemolysis, water hammer, and / or other harmful effects on blood and / or other medical fluids. In embodiments, the loop actuator(s) are any actuator and / or valve mechanism known in the art that can regulate the flow of fluid through a tube or associated structure. In various embodiments, loop actuators include pinch, solenoid, diaphragm, needle, globe, ball, rotary, gate, proportional, and / or check valve(s), and / or specialized microfluidic actuators (e.g., piezoelectric, electroosmotic, shape memory alloy).

[0022] In embodiments, the catheter-related medical devices disclosed herein consist of an alternating flow catheter, a control system, and / or injectors and / or consumables, either alone or in combination. In embodiments, the catheter-related medical devices perform gas exchange, dialysis, and / or trauma anesthesia through a single reduced-size (e.g., less than 5 mm (15 Fr)) intravascular cannula. In embodiments, the use of an alternating flow catheter increases catheter flow rate compared to a conventional (e.g., dual-lumen) catheter. In embodiments, the catheter-related medical devices result in reduced drainage, reduced recirculation, and / or simplified insertion. In embodiments, alternating flow does not mean that the fluid flows entirely through the same channel or lumen within the device, but rather that the catheter utilizes the nearly maximum internal functional cross-sectional area of ​​the outer catheter for both phases: the drainage phase (i.e., fluid leaving the body through the catheter) and the return phase (i.e., fluid entering the body through the catheter).

[0023] In embodiments, the alternating flow catheter disclosed herein has an outer catheter having one or more distal axial holes used for delivering return fluid and one or more proximal holes for fluid discharge. In embodiments, the inner diameter of the outer catheter is the maximum inner functional cross-sectional area of ​​the catheter. In embodiments, the alternating flow catheter achieves the use of nearly maximum inner functional cross-sectional area for both discharge and return by having a collapsible inner wall and / or sheath that, when inside the catheter, prevents the discharge fluid (e.g., blood, therapeutic fluid) from mixing with the return fluid (e.g., blood). In embodiments, when combined with one or more check valves, this minimizes and / or prevents mixing of oxygenated and deoxygenated blood when used for ECLS (i.e., recirculation).

[0024] In an embodiment, the alternating flow catheter disclosed herein achieves the use of a substantially maximum inner functional cross-sectional area for both drainage and return by moving within the outer catheter during the return phase so as to cover the proximal drainage holes for the fluid. During the return phase, the inner catheter moves to unseal the proximal drainage holes to enable drainage. In an embodiment, the movement of this inner catheter is at least partially caused by the movement of the fluid within the system. In an embodiment, the movement of this inner catheter is at least partially caused via direct actuation (e.g., an electric motor that causes movement).

[0025] In an embodiment, the alternating flow catheter disclosed herein achieves the use of a substantially maximum inner functional cross-sectional area for both drainage and return by using an inner catheter that moves proximally and distally. In an embodiment, the alternating flow catheter disclosed herein achieves the use of a substantially maximum inner functional cross-sectional area for both drainage and return by using an inner catheter that is a collapsible tube whose cross-sectional area decreases upon extension and increases upon relaxation.

[0026] In an embodiment, the alternating flow catheter disclosed herein achieves the use of a substantially maximum inner functional cross-sectional area for both drainage and return by using an inner catheter having holes that can fit into the proximal drainage holes of the outer catheter when in a particular configuration. The stage-dependent torsional movement on this inner catheter can cause occlusion of the outer proximal drainage holes during the return phase and unsealing of these holes during the drainage phase.

[0027] In an embodiment, the alternating flow catheter disclosed herein achieves the use of a substantially maximum inner functional cross-sectional area for both drainage and return by using an inner catheter having holes that can fit into the proximal drainage holes of the outer catheter when in a particular configuration. In this embodiment, the stage-dependent proximal-to-distal movement on the inner catheter can cause occlusion of the outer proximal drainage holes during the return phase and unsealing of these holes during the drainage phase.

[0028] In an embodiment, the alternating flow catheter disclosed herein has one or more balloons on the outside of the catheter that suppress vascular collapse (e.g., chattering) and / or reduce recirculation. In an embodiment, the alternating flow catheter has one or more distal check valves that reduce recirculation within the device. In an embodiment, the alternating flow catheter has the advantage of minimizing the thrombotic risk by preventing regions of stagnant flow via alternating delivery and / or minimizing damage to blood cells by using the overall catheter diameter (e.g., reducing shear stress due to increased flow).

[0029] In an embodiment, the catheter-related medical device disclosed herein utilizes a VV-femoral setup (e.g., to provide faster, safer, and / or more reliable access). In an embodiment, the catheter-related medical device reduces under-drainage that occurs when venous return is insufficient or when an overly negative drainage pressure develops. This is important because the blood flow in the VV-ECLS circuit is directly limited by the drainage volume. In an embodiment, the catheter-related medical device is placed via the Seldinger technique. In an embodiment, the catheter-related medical device partially improves venous drainage by having one or more suction ports (e.g., spanning a suction length of less than 20 cm). In an embodiment, the catheter-related medical device utilizes fluid pressures in the range of -42 Pa (-300 mmHg) to 42 MPa (300 mmHg) and / or a subset within that range.

[0030] In embodiments, the catheter-related medical device allows the user and / or control algorithm to modify the duration during which the system is draining and / or returning, thereby enabling real-time, direct adjustment of these stages to the patient's physiology. In embodiments, the alternating flow arrangement of the catheter-related medical device allows for system flexibility when attempting to match the return of venous side to arterial flow, which must be equal in a closed ECLS loop. Conventional multi-lumen or two-catheter systems have a fixed cross-section and constant flow, and therefore, when insufficient drainage occurs, the pump speed must be reduced, typically limiting them to fixed venous return. However, in embodiments, the catheter-related medical device has the ability to change the duration of the return and draining stages and / or individual pressure gradients, thus allowing for greater flexibility in setting up titrating to maximize system delivery in real time for a given patient. In embodiments, the catheter-related medical device operates in two stages performed sequentially (e.g., draining deoxygenated blood and returning oxygenated blood). In embodiments, the catheter-related medical device can independently change its overall cycle time and / or drain:return ratio. In one embodiment, the catheter-related medical device uses a software algorithm based on an internal sensor to optimize the flow.

[0031] In embodiments, the catheter-related medical devices disclosed herein minimize recirculation by having a distance along the tube from the discharge and return holes and / or by using at least partially occluded balloons around the outer catheter. In embodiments, the pulsatile flow of the catheter-related medical device is more physiological and synergistic with human physiology, thus reducing recirculation and / or coagulation.

[0032] In embodiments, the catheter-related medical devices disclosed herein unify intravascular access to a patient through a single intravascular device (e.g., fluid resuscitation, drug administration, blood collection). Typically, multi-lumen catheters are required for therapeutic agent delivery to prevent undesirable mixing within the catheter. For example, both calcium and blood products are present in trauma, but they cannot be injected together. Different intravenous (IV) lines add to the provider's workload, while multi-lumen catheters exhibit the aforementioned substantial flow reduction. However, in embodiments, the catheter-related medical devices function in a pulsating manner, allowing for more rapid and functional passage of specific products through the catheter.

[0033] In embodiments, the catheter-related medical devices disclosed herein utilize biocompatible materials, minimize wall thickness (e.g., by using coated wires and / or internal braids), and employ lubricating coatings to increase flow (e.g., PVP, PTFE, fluoropolymers) and / or prevent coagulation in heparin-free systems (e.g., PEO, albumin, pyrolytic carbon, phosphate, elastin-based). Furthermore, catheter-related medical devices utilize catheters having one or more of the following features: unbraided, braided, translucent, straight, curved, tapered, low profile, ramp, PEEK, ultra-high molecular weight polyethylene, carbon fiber, PET, iridium, platinum, iridium, stainless steel, Kevlar®, nitinol, radiopaque, silicone, polyurethane, polyvinyl chloride, polyethylene, polytetrafluoroethylene, polytetrafluoroethylene, braided reinforcement, coil reinforcement, longitudinal wire reinforcement, thin wall, lubricating coating, anticoagulant, ultra-thin wall liner, PTFE lining, hydrophilic coating, single lumen, multi-lumen, multi-durometer, marker bands (multiple), and / or radiopaque fillers (multiple).

[0034] In embodiments, the catheter-related medical device disclosed herein has a control system. In embodiments, the control system is portable, rugged, air-resistant, and / or self-contained. In embodiments, the control system is an ECLS and / or a dialysis system adapted to provide pulsating flow (rather than continuous flow).

[0035] In embodiments, the catheter-related medical devices disclosed herein are One of its features is that it makes it easier to place a VV-ECLS cannula at a single site using a smaller catheter (e.g., 5 mm (15 Fr) or less), It has the advantage of not requiring the confirmation of cannula placement using bulky methods (such as fluoroscopy), It features high durability and is designed for pre-hospital use with reduced size, weight, and power consumption. It facilitates the execution of cannulation, which in turn enables deployment by non-specialized providers. Features include the use of closed-loop control algorithms for fluid, chemical, and gas exchange management, incorporating relevant intelligent safety functions. It has the characteristic of providing both trauma resuscitation and / or blood oxygenation, An ECLS system that has one or more of the following characteristics: improved oxygen transport, minimized thrombotic risk, and longer duration of use (e.g., 48 hours or more).

[0036] In embodiments, the catheter-related medical devices disclosed herein provide (1) continuous VV-ECLS, (2) rapid fluid infusion, (3) ongoing pressurizer support (e.g., continuous administration of mini-bolus pressurizers), and / or (4) automated administration of other beneficial agents (e.g., TXA, calcium). In embodiments, the catheter-related medical devices can treat hemorrhagic shock in an automated and / or semi-automated manner. In embodiments, the catheter-related medical devices enable rapid fluid infusion (e.g., of heated whole blood) through an alternating flow catheter. In embodiments, delivery is controlled by a closed-loop algorithm. In embodiments, the catheter-related medical devices have one or more sensors (e.g., pressure, temperature, lab test). In embodiments, the catheter-related medical devices automate life-saving emergency care and provide closed-loop administration of pressurizers and other therapeutic agents with minimal human supervision.

[0037] Here, methods and apparatus related to medical technology have been illustrated and described. While specific embodiments of this disclosure have been described, this disclosure is intended to enable the broad scope of the art and is not intended to be limited thereto, as the specification should be read similarly.

[0038] While the catheter-related medical devices disclosed herein have been described with a certain degree of specificity, it is evident that many modifications can be made to the details of the configuration and the arrangement of components without departing from the spirit and scope of this disclosure. This disclosure is not limited to the embodiments described herein for illustrative purposes, and it is understood that elements of a particular embodiment can be combined with elements of other embodiments. Further objects, advantages, and novel features of this disclosure are described below and will become apparent to those skilled in the art upon consideration of the following detailed description and drawings. It should be understood that not all of the described features are required to be incorporated into a given system or method. [Brief explanation of the drawing]

[0039] [Figure 1]Figure 1 is an isometric view of a catheter-related medical device according to one embodiment of the present disclosure. [Figure 2] Figure 2 is a cross-sectional view of a catheter-related medical device according to one embodiment of the present disclosure. [Figure 3] Figure 3 is an isometric view of a catheter-related medical device according to one embodiment of the present disclosure. [Figure 4] Figure 4 is a cross-sectional view of a catheter-related medical device according to one embodiment of the present disclosure. [Figure 5] Figure 5 is an isometric view of a catheter-related medical device according to one embodiment of the present disclosure. [Figure 6] Figure 6 is a schematic diagram of a catheter-related medical device according to one embodiment of the present disclosure. [Figure 7] Figure 7 is a schematic diagram of a catheter-related medical device according to an embodiment of the present disclosure. [Figure 8] Figure 8 is a schematic diagram of a catheter-related medical device according to an embodiment of the present disclosure. [Figure 9] Figure 9 is a schematic diagram of a catheter-related medical device according to an embodiment of the present disclosure. [Figure 10] Figure 10 is a schematic diagram of a catheter-related medical device according to an embodiment of the present disclosure. [Figure 11] Figure 11 is a schematic diagram of a catheter-related medical device according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0040] Referring to the figures, Figures 1 and 2 schematically illustrate one embodiment of a part of the present disclosure. In this embodiment, an alternating flow catheter 20 is shown, comprising an outer catheter 30, an inner catheter 40, a catheter cap 50, and one or more balloons 60. In this embodiment, the outer catheter 30 further has one or more distal axial holes 32, one or more proximal holes 34, a fixed area 36, ​​and a check valve 38. In this embodiment, the inner catheter 40 further has one or more distal axial holes 42, one or more proximal holes 44, and an alternating flow control mechanism 45. The alternating flow control mechanism 45 further has an alternating flow actuator 46, one or more main flow channels 47, one or more auxiliary flow channels 48, and one or more catheter return holes 49. In this embodiment, the catheter cap 50 further has a tube connector 52 and a gasket 54. Some embodiments do not include the balloon 60. In some embodiments, the tube connector 52 is a standard Luer connector (e.g., male or female).

[0041] In this embodiment, the alternating flow catheter 20 is shown to draw fluid from the body (i.e., the draining phase). A tube connected from the rest of the system (not shown in these figures) connects to the tube connector 52, and in this draining phase, a vacuum is formed within the central part of the catheter cap 50. In these figures, this causes the alternating flow control mechanism 45 to move to its proximal position with reference to the catheter cap 50 and the outer catheter 30. The catheter return hole 49 and auxiliary channel 48 simultaneously ensure that the alternating flow actuator 46 can move freely to this proximal position without its operation being hindered by the accumulation of vacuum between the distal side of the alternating flow actuator 46 and the outer catheter 30 and / or catheter cap 50. Some embodiments do not include the catheter return hole 49 and / or auxiliary channel 48.

[0042] Because the alternating flow control mechanism 45 is located proximal to it, the proximal hole 44 on the inner catheter 40 is aligned with the proximal hole 34 on the outer catheter 30. This allows fluid from outside the catheter (e.g., blood in the vascular structure) to be drawn into the catheter through these holes. Furthermore, the vacuum within the device causes the check valve 38 on the outer catheter 30 to be in the closed position, preventing fluid from being drawn in through the distal axial hole 32 (for example, reducing recirculation when used in ECLS). Some embodiments do not include the check valve 38.

[0043] Figures 3 and 4 generally show the alternating flow catheter 20 when delivering fluid into the body (i.e., the return phase). A tube connected from the rest of the system (not shown in these figures) connects to the tube connector 52, which in this return phase builds pressure within the central part of the catheter cap 50. In these figures, this causes the alternating flow control mechanism 45 to move distally to the catheter cap 50 and the outer catheter 30. The catheter return hole 49 and accompanying channel 48 simultaneously ensure that the alternating flow actuator 46 can move freely to this distal position without its operation being hindered by the pressure rise between the alternating flow actuator 46 and the distal side of the outer catheter 30 and / or catheter cap 50. Some embodiments do not include the catheter return hole 49 and / or accompanying channel 48.

[0044] Because the alternating flow control mechanism 45 is located distally, the proximal hole 44 on the inner catheter 40 is not aligned with the proximal hole 34 on the outer catheter 30 (i.e., the inner catheter 40 blocks the proximal hole 34 on the outer catheter 30). This prevents the fluid inside the catheter (e.g., blood and / or therapeutic fluid) from flowing through the proximal hole 34 of the outer catheter 30. Instead, the pressure within the device opens a check valve 38 on the outer catheter 30, allowing the fluid to be discharged only through the distal axial hole 32. Some embodiments do not include the check valve 38.

[0045] It will be apparent to those skilled in the art, after examining the above-described figures, that the alternating flow catheter 20 can achieve the objective of facilitating the proximal and distal return of blood and / or other medical fluids by utilizing mechanisms other than the proximal and distal movement of the inner catheter 40 with respect to the outer catheter 30. In embodiments, this objective is instead achieved via the rotational movement of the inner catheter 40 related to the outer catheter 30, via a plurality of small check valves across the proximal bore 44 and / or proximal bore 34, and / or via other associated mechanisms. In embodiments, the alternating flow control mechanism 45 is at least partially actuated directly via the flow rate and / or pressure of blood and / or other medical fluids in the system. In embodiments, the alternating flow control mechanism 45 is partially or fully actuated directly from a control system (e.g., via direct wire, wireless, remote control, fieldbus and industrial communication protocols, via hydraulic, pneumatic, optical, acoustic, implantable and smart actuator interfaces and / or controls). In embodiments, such alternating flow control mechanism actuators include electromagnetic actuators (e.g., solenoids, electromagnetic relays / clutches, voice coil actuators, electric motors), electrostatic actuators (e.g., micro-electromechanical systems, precision positioning plates), piezoelectric actuators (e.g., ultrasonic transducers, precision optical positioners), thermal actuators (e.g., shape memory alloys, bimetallic strips, thermal expansion actuators), hydraulic actuators (e.g., cylinders / pistons, hydraulic motors), pneumatic actuators (e.g., pneumatic cylinders, rotary pneumatic actuators, flexible pneumatic actuators), and / or mechanical / energy storage actuators (e.g., springs, cams, linkage mechanisms, magnetic shape memory alloys).

[0046] Figure 5 schematically illustrates another embodiment of a part of the present disclosure. In this embodiment, the alternating flow catheter 120 achieves the use of nearly maximum internal functional cross-sectional area for both discharge and return by including a collapsible inner wall and / or sheath 170. In this embodiment, the alternating flow catheter 120 is shown comprising an outer catheter 130, a collapsible inner wall and / or sheath 170, and a catheter cap 150. In this embodiment, the outer catheter 130 further has one or more distal axial holes 132, one or more proximal holes 134, and a fixation area 136. In this embodiment, the catheter cap 150 further has a discharge port 156, one or more port clamps 157, a return port 158, and a hub with a hemostatic valve 159. To facilitate intravascular placement, this embodiment additionally has an expander 180 for use with Serdinga technology. The discharge port 156 allows for the removal of fluid (e.g., deoxygenated blood) from the alternating flow catheter 120. The return port 158 ​​allows fluid (e.g., oxygenated blood) to be introduced into the alternating flow catheter 120. One or more port clamps 157 allow clamping of the discharge port 156 and / or the return port 158. A hub with a hemostatic valve 159 allows the dilator 180 to be placed inside the alternating flow catheter 120 during setup and / or provides a check valve function to prevent fluid from leaving the alternating flow catheter 120 when the dilator 180 is removed (e.g., for use in the placement of Selinger technology).

[0047] Referring to Figures 6 and 7, in this embodiment, alternating flow control is performed by a collapsible inner wall and / or sheath 170 that works in conjunction with check valves 190 and 192. When a vacuum is placed at the discharge port 156 (Figure 6), the check valve 192 opens and the inner wall and / or sheath 170 collapses. This draws fluid through the channel 196 created by the inner wall and / or sheath 170, which collapses in contact with one side of the outer catheter 130, further exposing one or more proximal holes 134 and allowing fluid (e.g., deoxygenated blood) to be drawn into the alternating flow catheter 120. When pressurized fluid (e.g., oxygenated blood) is placed at the return port 158 ​​(Figure 7), the check valve 190 opens and the inner wall and / or sheath 170 expands. This allows fluid to be pushed through the channel 194 created by the inner wall and / or sheath 170 that expands within the outer catheter 130, closing the path to one or more proximal holes 134 and exposing the path to one or more distal axial holes 132, thereby pushing fluid out from the distal portion of the alternating flow catheter 120. In some embodiments, one or more of the discharge port 156, return port 158, and hub are combined with a hemostatic valve 159. In embodiments, the anti-backflow valves 190 and 192 are functionally located within a connecting tube or control system instead of the alternating flow catheter 120.

[0048] Figure 8 schematically illustrates another embodiment of a part of the present disclosure. In this embodiment, the alternating flow catheter 20 achieves nearly maximum use of the internal functional cross-sectional area for both discharge and return without an alternating flow control mechanism that closes or opens the proximal hole 34 of the outer catheter 30. Rather, in the embodiment, the alternating flow catheter 20 is designed so that its fluid dynamics section facilitates preferential withdrawal of fluid from the proximal hole 34 during the discharge phase and preferential discharge of fluid through the distal axial hole 32 during the return phase (e.g., retention size, hole arrangement, hole shape, number of holes). Some embodiments do not include a check valve 38. In some embodiments, the alternating flow catheter 20 does not have a special fluid dynamics section, but recirculation is minimal enough to allow sufficient device function (e.g., due to the surrounding patient vascular anatomy).

[0049] Figure 9 schematically illustrates another embodiment of a part of the present disclosure. This embodiment shows a system comprising an alternating flow catheter 20, a connecting tube 100, a control system 200, and one or more inputs and / or consumables 300. The control system 200 comprises one or more of the following: a user interface 210, a gas mixer 220, a pump 230, an artificial lung 240, a heat exchanger 250, a perfusion circuit and / or filter 260, an actuator 270, a reservoir 280, a blood analyzer 290, an alarm 205, a battery 215, a processor 225, a control algorithm 235, and / or a sensor 245. The inputs and / or consumables 300 comprises one or more of the following: oxygen 310, a blood product 320, a fluid 330, and / or a drug 340.

[0050] In an embodiment, the control system 200 is one of many conventional ECLS systems connected to an intravascular catheter via a tube. Many conventional ECLS systems essentially drain blood in a single loop and return it to the body using a single pump and a single reservoir. In an embodiment, the control system 200 is a standard ECLS system that is initially modified for use with an alternating flow catheter 20. Conventional ECLS systems utilize a continuous flow and must therefore be used as disclosed herein, and must deliver alternating flow between oxygenated blood being returned to the body and deoxygenated blood being drained from the body via a single alternating flow catheter 20. In embodiments, this is achieved by one or more of the following: an additional reservoir 280 (for example, to allow blood to accumulate in the system between alternating flows), one or more distal actuators 270 (for example, near the alternating flow catheter 20 to alternate drain and return flows to the alternating flow catheter 20), a three-way stopcock or associated mechanism for alternating the fluid path from the outer tube to the catheter, one or more additional pumps 230, and / or one or more additional perfusion circuits, and / or filters 260.

[0051] In one embodiment, blood is drained (i.e., withdrawn from the body) through an alternating flow catheter 20 and proceeds to a control system 200 through a connecting tube 100. The blood can be retained in the control system 200 within a drain reservoir 280. In one embodiment, a single pump 230 draws the blood into the system, which is then pumped through an oxygen supply unit 240 (for example, to add oxygen and / or remove carbon dioxide from the blood). This can utilize the use of inputs and / or consumables 300 (e.g., oxygen 310, heparin, fluid). In one embodiment, this is done in conjunction with a gas mixer 220 that regulates the levels of oxygen and / or carbon dioxide in the system. The blood can then be retained in a return reservoir 280. In one embodiment, there is a second pump 230 that causes the blood to be pushed out through the alternating flow catheter 20. In one embodiment, a heat exchanger 250 warms the blood before it is placed back into the body. In the embodiment, perfusion circuits (or multiple) and / or filters (or multiple) 260 filter the blood and / or return it to the return connection tube 100. In the embodiment, the user interacts with the control system 200 using a user interface 210, alarms 205 can be set to notify the user of specific parameters, actuators 270 operate the device, batteries 215 and / or wall outlets supply power to the system, sensors 245 detect the functionality of the system (e.g., blood pressure, oxygen level, blood carbon dioxide level, blood coagulation), a blood analyzer 290 tests the blood for one or more characteristics (e.g., hemoglobin, glucose, lactate, pH), and a processor 225 controls the system using a control algorithm 235.

[0052] Figures 10-11 schematically illustrate another embodiment of a part of the present disclosure. Figure 10 shows a catheter-related medical device comprising an alternating flow catheter 20, a connecting tube 100, and a control system 200 in the extraction stage for draining blood from a body. In this embodiment, blood is drained through the alternating flow catheter 20 (i.e., drained from the body) and proceeds to the control system 200 through the connecting tube 100. The connecting tube 100 is connected to the control system 200 via a three-way stopcock or associated mechanism 401. The blood then moves through an extraction circuit loop consisting of tube sections 261, 262, 263, and 264. In this embodiment, the blood is caused to move preferentially within the extraction perfusion circuit loop by the setting of actuators 272 and 274 (e.g., pinch valves in some embodiments), thereby the relative resistance between tube sections 261 and 264 and tube sections 263 and 265 preferential to flow through tube sections 261 and 263 (i.e., the extraction loop). The flow is powered by the pump 230, which causes blood to flow into the pump 230 through actuator 272 and into the reservoir 280 through actuator 274 and oxygen supply 240. The blood is then preferentially accumulated in the reservoir 280 during the draining phase. When a sensor on the reservoir 280 determines that the volume in the reservoir 280 has reached a desired level and / or amount based on the control algorithm, the control system 200 switches from the draining phase to the return phase.

[0053] Figure 11 shows the system in the return phase for injecting blood and / or other medical fluids into the body. In this embodiment, movement through this perfusion circuit loop is powered by pump 230, causing blood to flow from reservoir 280 through actuator 272 into pump 230, through pump 230, actuator 274, and bubble trap 282 to connecting tube 100 and alternating flow catheter 20, into the patient's body (e.g., the femoral vein with catheter extension direction toward the lower part of the IVC). In this embodiment, blood is preferentially caused to move through the return perfusion circuit loop, as set by actuators 272 and 274, so that the relative resistance between tube sections 261 and 264 and tube sections 263 and 265 favors the flow through tube sections 264 and 265 (i.e., the return loop). Therefore, blood is preferentially removed from reservoir 280 during this phase. When a sensor on the reservoir 280 determines, based on the control algorithm, that the volume within it has reached a desired level, the control system 200 switches from the return phase to the discharge phase. Thus, by alternating between the discharge phase and the return phase, the system can provide alternating flow through the alternating flow catheter 20.

[0054] In embodiments, the three-way stopcock or associated mechanism 401 allows priming of the system with blood and / or medical fluid (e.g., ordinary saline solution) during a setup phase (not shown). In embodiments, the active operation of the three-way stopcock or associated mechanism 401 is a distal actuator, which further facilitates the transition between the discharge phase and the return phase. In embodiments, actuators 272 and 274 each consist of two or more valves (e.g., pinch valves on tubular sections 261 and 264), while in other embodiments, they are a single pinch valve that alternately switches between pinching the tubular sections. In embodiments, the relative closures and / or resistance actuators 272 and 274 can be controlled from fully open, through a gradient of partial closure, and / or complete closure of the loop. In embodiments, a control algorithm and / or user can apply different settings for the discharge phase and the return phase to different loops. In the embodiment, the discharge and return phases are actively and / or passively coordinated with the alternating flow catheter 20 such that discharge from the catheter preferentially occurs from the proximal end of the catheter and returns through its distal end.

[0055] In one embodiment, a catheter-based medical device may have at least one alternating flow catheter configured to allow fluid flow in one direction and then in the opposite direction within a lumen of an outer catheter having at least one distal axial hole and at least one proximal hole. The system may further have at least one control system having a tube configured to connect at least one control system to at least one alternating flow catheter, at least one pump configured to drive fluid through at least one alternating flow catheter, at least one reservoir configured to temporarily store fluid, and at least one sensor configured to determine the amount of fluid in the reservoir.

[0056] In some embodiments, at least one control system further comprises one or more oxygen suppliers.

[0057] In some embodiments, at least one control system is configured to execute one or more software algorithms for controlling the flow of fluid through an alternating flow catheter.

[0058] In some embodiments, the control system further comprises one or more loop actuators configured to cause a change in the direction of fluid flow within at least one alternating flow catheter.

[0059] In some embodiments, at least one control system comprises at least two fluid circuit loops.

[0060] In some embodiments, the fluid circuit loop comprises at least two components: a discharge loop from which fluid is drawn from the patient's body and stored in a reservoir, and a return loop from which fluid flows from the reservoir and is injected into the patient's body.

[0061] In some embodiments, the fluid flow through the alternating flow catheter has a drainage phase in which the fluid is withdrawn from the patient's body and a return phase in which the fluid is returned to the patient's body.

[0062] In some embodiments, at least one control system is configured to utilize an alternating flow catheter for extracorporeal life support.

[0063] In some embodiments, at least one control system is configured to utilize an alternating flow catheter for dialysis.

[0064] In some embodiments, at least one alternating flow catheter further comprises an inner catheter located within an outer catheter and having at least one distal axial hole and at least one proximal hole.

[0065] In some embodiments, in the withdrawal position, at least one proximal hole of the inner catheter is aligned with at least one proximal hole of the outer catheter to allow fluid to flow into the lumen through the proximal hole, and in the return position, at least one proximal hole of the inner catheter is not aligned with at least one proximal hole of the outer catheter to prevent fluid from flowing through it from within the lumen.

[0066] In some embodiments, when the inner catheter is in the return position, the pressure within the alternating flow catheter causes fluid to flow out from at least one distal axial hole of the inner catheter and at least one distal axial hole of the outer catheter.

[0067] In some embodiments, when the inner catheter is in the withdrawal position, fluid does not flow into at least one distal axial hole of the inner catheter or at least one distal axial hole of the outer catheter.

[0068] In some embodiments, the alternating flow catheter further comprises an alternating flow control mechanism configured to move the inner catheter between an extraction position and a return position.

[0069] In some embodiments, at least one proximal hole of the inner catheter is configured to align with at least one proximal hole of the outer catheter, and the alternating flow catheter is provided with a fluid force section that draws fluid through the proximal hole during the discharge phase and discharges fluid through the distal axial hole during the return phase.

[0070] Various embodiments of systems, apparatus, and methods have been described herein. These embodiments are given only as examples and are not intended to limit the scope of this disclosure. Furthermore, it should be understood that various features of the embodiments described can be combined in various ways to produce many additional embodiments. In addition, various materials, dimensions, shapes, configurations, and positions have been described for use with the disclosed embodiments, but other materials may be used without exceeding the scope of this disclosure.

[0071] Those skilled in the art will recognize that the subject matter herein may contain fewer features than those illustrated in any of the individual embodiments described above. The embodiments described herein are not intended to be an exhaustive presentation of how various features of the subject matter herein can be combined. Thus, the embodiments are not mutually exclusive combinations of features, but rather, the various aspects may comprise different combinations of individual features selected from different individual embodiments, as will be understood by those skilled in the art. Furthermore, elements described in reference to one embodiment may be implemented in other embodiments even if they are not described in that embodiment, unless otherwise noted.

[0072] A dependent claim may refer to a specific combination with one or more other claims, but other embodiments may also have combinations of a dependent claim with the subject matter of each dependent claim or combinations of one or more features with other dependent or independent claims. Such combinations are proposed herein unless otherwise stated that a particular combination is not intended.

[0073] Any incorporation by reference to the above-mentioned documents is limited so as not to incorporate any subject matter contrary to the express disclosure herein. Any incorporation by reference to the above-mentioned documents is further limited so as not to incorporate any claims contained in such documents by reference herein. Any incorporation by reference to the above-mentioned documents is further limited so as not to incorporate any definitions provided in such documents by reference unless expressly included herein.

[0074] For the purpose of interpreting the claims, Section 112(f) of the U.S. Patent Act is expressly intended not to be invoked unless the specific terms “for” or “step for” are explicitly stated in the claims.

Claims

1. In catheter-based medical devices, The aforementioned medical device is At least one alternating flow catheter, configured to allow unidirectional fluid flow and subsequent opposite fluid flow within the lumen of an outer catheter having at least one distal axial hole and at least one proximal hole, At least one control system, A tube configured to connect the at least one control system to the at least one alternating flow catheter, At least one pump configured to drive fluid through the at least one alternating flow catheter, A reservoir configured to temporarily store fluid, A catheter-based medical device comprising at least one control system having at least one sensor configured to determine the amount of fluid in the reservoir.

2. The catheter-based medical device according to claim 1, wherein the at least one control system further comprises one or more oxygen supplyers.

3. The catheter-based medical device according to claim 1, wherein the at least one control system is configured to execute one or more software algorithms for controlling the flow of fluid through the alternating flow catheter.

4. The catheter-based medical device according to claim 1, wherein the at least one control system further comprises one or more loop actuators configured to cause a change in the direction of fluid flow in the at least one alternating flow catheter.

5. The catheter-based medical device according to claim 1, wherein the at least one control system comprises at least two fluid circuit loops.

6. The catheter-based medical device according to claim 5, wherein the at least two fluid circuit loops include a discharge loop from which fluid is withdrawn from the patient's body and stored in the reservoir, and a return loop from which fluid flows from the reservoir and is injected into the patient's body.

7. A catheter-based medical device according to any one of claims 1 to 6, wherein the fluid flow through the alternating flow catheter has a discharge stage in which the fluid is drawn out of the patient's body and a return stage in which the fluid is returned to the patient's body.

8. The catheter-based medical device according to any one of claims 1 to 6, wherein the at least one control system is configured to utilize the alternating flow catheter for extracorporeal life support.

9. The catheter-based medical device according to any one of claims 1 to 6, wherein the at least one control system is configured to utilize the alternating flow catheter for dialysis.

10. The catheter-based medical device according to any one of claims 1 to 6, wherein the at least one alternating flow catheter further comprises an inner catheter disposed within the outer catheter and having at least one distal axial hole and at least one proximal hole.

11. At the withdrawal position, the at least one proximal hole of the inner catheter is aligned with the at least one proximal hole of the outer catheter so as to allow fluid flow into the lumen through the proximal hole. A catheter-based medical device according to claim 10, wherein, in the return position, the at least one proximal hole of the inner catheter is not aligned with the at least one proximal hole of the outer catheter in order to prevent fluid in the lumen from flowing through it.

12. A catheter-based medical device according to claim 11, wherein when the inner catheter is in the return position, the pressure in the alternating flow catheter causes fluid to flow out from the at least one distal axial hole of the inner catheter and the at least one distal axial hole of the outer catheter.

13. The catheter-based medical device according to claim 11, wherein when the inner catheter is in the withdrawal position, the fluid does not flow into the at least one distal axial hole of the inner catheter or the at least one distal axial hole of the outer catheter.

14. The catheter-based medical device according to claim 11, further comprising an alternating flow control mechanism configured to move the inner catheter between the withdrawal position and the return position.

15. The at least one proximal hole of the inner catheter is configured to align with the at least one proximal hole of the outer catheter. The catheter-based medical device according to claim 10, wherein the alternating flow catheter is provided with a fluid dynamics section that aspirates fluid through the proximal hole during the discharge phase and discharges fluid through the distal axial hole during the return phase.

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