EP-4740976-A1 - ALTERNATING FLOW INTRAVASCULAR CATHETERS AND RELATED TECHNOLOGIES

Abstract

An improved method and device for improved catheters and/or related technologies. The device generally comprises an improved medical technology. The provided device substantially improves upon catheter-related medical device technology.

Inventors

• Donaldson, Ross I.
• BUCHANAN, Oliver
• YESAYAN, Zhirair
• YOUNG, TYLER
• SCAGLIONE, Bernard
• INGAMELLS, Grant

Assignees

• Critical Innovations, LLC

Dates

Publication Date

20260513

Application Date

20250908

Claims (15)

1. A catheter-based medical device, comprising: at least one alternating-flow catheter configured to enable flow of fluid in one direction followed by flow of fluid in an opposite direction at least partially within a lumen of an outer catheter containing at least one distal axial hole and at least one proximal hole; and at least one control system including: tubing configured to connect the at least one control system to the at least one alternating-flow catheter; at least one pump configured to drive a fluid through the at least one alternating-flow catheter; at least one reservoir configured to temporarily store a fluid; and at least one sensor configured to determine an amount of the fluid in the reservoir.
2. The catheter-based medical device of claim 1, wherein the at least one control system further comprises one or more oxygenators.
3. The catheter-based medical device of claim 1 or claim 2, wherein the at least one control system is configured to execute one or more software algorithms to control flow of fluid through the alternating-flow catheter.
4. The catheter-based medical device of any of claims 1-3, wherein the at least one control system further comprises one or more loop actuators configured to cause a change in direction of fluid flow in the at least one alternating-flow catheter.
5. The catheter-based medical device of any of claims 1-4, wherein the at least one control system comprises at least two fluid circuit loops.
6. The catheter-based medical device of claim 5, wherein the at least two fluid circuit loops include a drainage loop in which fluid is withdrawn from a body of a patient and stored in the reservoir and a return loop in which fluid flows from the reservoir and is infused into the body of the patient.
7. The catheter-based medical device of any claims 1-6, where the flow of fluid through the alternating-flow catheter includes a drainage phase in which fluid is withdrawn from a body of a patient and a return phase in which fluid is returned to the body of the patient.
8. The catheter-based medical device of any of claims 1-7, wherein the at least one control system is configured to utilize the alternating-flow catheter for Extracorporeal Life Support or dialysis.
9. The catheter-based medical device of any of claims 1-8, wherein the at least one alternating-flow catheter further comprises an inner catheter disposed within the outer catheter and including at least one distal axial hole and at least one proximal hole.
10. The catheter-based medical device of claim 9, wherein in a 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 to enable flow of fluid into the lumen through the proximal holes and in a return position the at least one proximal hole of the inner catheter is misaligned with the at least one proximal hole of the outer catheter to prevent fluid from within the lumen from flowing therethrough.
11. The catheter-based medical device of claim 10, wherein when the inner catheter is in the return position pressure within the alternating-flow catheter causes fluid to flow out of the at least one distal axial hole of the inner catheter and the at least one distal axial hole of the outer catheter.
12. The catheter-based medical device of claim 10, wherein when the inner catheter is in the withdrawal position 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.
13. The catheter-based medical device of claim 11, wherein the alternating-flow catheter further includes an alternating-flow control mechanism configured to cause the inner catheter to move between the withdrawal position and the return position.
14. The catheter-based medical device of claim 9, wherein the at least one proximal hole of the inner catheter is configured to be aligned with the at least one proximal hole of the outer catheter, and wherein the alternating-flow catheter is provided with flow dynamics that cause fluid to be drawn through the proximal holes during a drainage phase and fluid to be ejected through the distal axial holes during a return phase.
15. An alternating-flow catheter for use with the catheter-based medical device of any of claims 1-14.

Description

Priority Claim The present application claims the benefit of U.S. Provisional Patent Application No. 63/717,987 filed November 8, 2024, which is hereby incorporated by reference in its entirety. Commonly Owned Applications U.S. Patent No. 9,616,203, filed August 7, 2013 and 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 and entitled Percutaneous Channel System and Method; U.S. Patent No. 10,814,119, filed August 27, 2018 and entitled Percutaneous Access Pathway System; U.S. Patent No. 11,207,060, filed March 15, 2019 and entitled Systems and Methods Relating to Medical Applications of Synthetic Polymer Formulations; U.S. Patent No. 11,832,833, filed October 5, 2020 and entitled Percutaneous Access Pathway System; U.S. Patent Application Serial No. 17/876,187, filed July 28, 2022 and entitled Wound Treatment Device; U.S. Patent Application Serial No. 18/448,455, filed August 11, 2023 and entitled Percutaneous Access Pathway System; U.S. Patent Application Serial No. 18/485,800, filed October 12, 2023 and entitled Systems and Methods Relating to Medical Applications of Inverse Thermosensitive Polymer Foam Formulations; and U.S. Patent Application Serial No. 18/926,615, filed October 25, 2024 and entitled Autoinjector Assembly are hereby incorporated by reference herein in their entireties. US Government License Rights This invention was made with US Government support under contract N6600124C0031, "Revite™ Automated Trauma Resuscitation System," issued by NAVAL INFORMATION WARFARE CENTER PACIFIC. The US Government has certain rights in the invention. Technical Field The present disclosure relates generally to alternating flow technologies, including improved catheter-related medical devices and/or related technologies. Background Extracorporeal Life Support (ECLS) (e.g., extracorporeal membrane oxygenation [ECMO], cardiopulmonary bypass [CPB], extracorporeal cardiopulmonary resuscitation [ECPR]) have advanced dramatically over the last decade and improved the management of patients with refractory respiratory and/or cardiac failure in a variety of settings. Although initial complex and bulky systems were previously limited to specialized quaternary centers, incremental technological improvements have resulted in miniaturized ECLS circuits that allow wider usage, including for a wider range of in-hospital settings (e.g., intensive care unit, emergency department, in-theater military settings) and indications (e.g., extracorporeal cardiopulmonary resuscitation [eCPR], trauma, drug overdose, bridges to therapy). There has been a similar progression of dialysis technologies. While the main machinery has greatly progressed, deployment of ECLS has continued to be hindered by the need to establish appropriate vascular access with more limited expertise or setting limitations. The use of venovenous (VV) ECLS through a single dual-lumen cannula has simplified some access requirements by requiring only one catheter to be placed. However, this still requires insertion of a very large cannula, as well as in most cases the need for advanced imaging (e.g., fluoroscopy and transesophageal echocardiography [TEE]) to guide and confirm correct cannula position. Unfortunately, this prevents ECLS from being more widely initiated. In contrast, establishing standard central-line venous access and dialysis catheter access, which utilize smaller catheters than ECLS, is an essential and established skill for a wide range of advanced providers that care for the critically ill (e.g., critical care, emergency, trauma specialists). These procedures are used frequently during critical care resuscitation to establish a route for rapid administration of fluids, blood products, medications, and emergent dialysis. These procedures can also be performed in conjunction with point-of-care (POC) ultrasound, which is now widely available and has been demonstrated to improve procedural success and reduce complications. POC ultrasound has a very small logistical footprint, with some handheld versions currently weighing ~140g (0.3lbs) and medics have been shown to be capable of using this technology in the out-of-hospital setting. This distinguishes POC ultrasound from TEE and fluoroscopy, which require specialized skills to deploy and have very large and unwieldy equipment. As aforementioned, the prior art demonstrates that VV-ECLS is of benefit and can be performed through a single dual-lumen cannula (typically 23-31 Fr) in the internal jugular vein (IJV) (e.g., Avalon Elite Catheter by Getinge). This simplifies the ECLS procedure by requiring cannulation of only one vessel. However, blood flow in this circuit is directly determined by the limited, fixed drainage capacity of its catheter (most frequently its venous intake), thus requiring a very large catheter size, with subsequent increased complication risk and procedural difficulty