IP Library › Granted Patent US 12,186,469
Granted Patent B2
US 12,186,469 · App. 18/455,444 · Granted Jan 7, 2025

Expandable ECMO extension cannula system

Inventor: Navin K. Kapur (Hanover, MA)
Assignee: Tufts Medical Center, Inc.
A61M1/3613A61M1/3659A61M2025/0024A61M2210/127
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Quick Facts
Patent No.
US 12,186,469
App. No.
18/455,444
Granted
Jan 7, 2025
Kind
B2
Abstract

An extension cannula for use with a conventional ECMO return cannula is provided. The extension cannula includes a flexible conduit transitionable between a collapsed insertion state and an expanded deployed state when in communication with blood flow from an ECMO machine via the ECMO return cannula. The extension cannula may be positioned through a conventional ECMO return cannula such that the proximal end of the flexible conduit is disposed within and proximal to the end of the ECMO return cannula, while the distal end of the flexible conduit is disposed in a patient's thoracic aorta to deliver oxygenated blood directly to the patient's thoracic aorta via one or more pores at the distal region of the flexible conduit to improve cerebral oxygenation, maintain systemic arterial pulsatility, and reduce the potential for end-organ injury.

Claims (35)

1. A method for improving systemic perfusion, the method comprising:

selecting an extension cannula having a distal region coupled to an elongated shaft and a proximal region coupled to an outlet of an ECMO return cannula, the elongated shaft configured so that a blood flow path does not pass through the elongated shaft;

advancing the distal region of the extension cannula within a patient's vasculature via the elongated shaft such that the extension cannula extends from a location proximal to the patient's renal vessels to a location beyond the patient's renal vessels;

fluidically coupling an inlet of the ECMO return cannula to an ECMO machine;

transitioning the extension cannula from a collapsed insertion state to an expanded deployed state when in communication with a blood flow from the ECMO machine; and

delivering the blood flow through a lumen of the extension cannula in the expanded state to the location beyond the patient's renal vessels via an outlet at the distal region of the extension cannula to thereby improve systemic perfusion.

2. The method of claim 1 , wherein the outlet of the extension cannula comprises a plurality of pores disposed at the distal region of the extension cannula.

3. The method of claim 1 , wherein the proximal region of the extension cannula is configured to be fixedly coupled to the outlet of the ECMO return cannula.

4. The method of claim 1 , wherein the extension cannula comprises at least one of polyethylene, polyurethane, or nylon.

5. The method of claim 1 , wherein the elongated shaft extends from the distal region of the extension cannula proximally along a lateral side of the extension cannula.

6. The method of claim 1 , wherein the elongated shaft extends from the distal region of the extension cannula proximally within the lumen of the extension cannula along a central longitudinal axis of the extension cannula.

7. The method of claim 1 , wherein the elongated shaft is embedded within a wall of the extension cannula, such that the elongated shaft extends from the distal region of the extension cannula proximally through the wall of the extension cannula.

8. The method of claim 1 , wherein advancing the distal region of the extension cannula within the patient's vasculature comprises advancing the distal region of the extension cannula within the patient's vasculature such that the extension cannula extends from the location proximal to the patient's renal vessels to a location within the patient's descending aorta or thoracic aorta.

9. The method of claim 1 , wherein delivering the blood flow through the lumen of the extension cannula to the location beyond the patient's renal vessels reduces left heart workload and myocardial damage.

10. The method of claim 1 , wherein delivering the blood flow through the lumen of the extension cannula to the location beyond the patient's renal vessels enhances antegrade blood flow to the patient's descending aorta and adjoining arteries, thereby unloading the patient's left ventricle, reducing cardiac output at a lower pressure, and decreasing left and right ventricular workload.

11. The method of claim 1 , further comprising:

advancing a guidewire within the patient's vasculature to the location beyond the patient's renal vessels,

wherein advancing the distal region of the extension cannula within the patient's vasculature via the elongated shaft comprises advancing a distal end of the elongated shaft over the guidewire via a guidewire lumen extending through the elongated shaft.

12. The method of claim 11 , wherein fluidically coupling the inlet of the ECMO return cannula to the ECMO machine comprises coupling an inlet of a connector to the ECMO machine, the connector comprising an outlet coupled to the inlet of the ECMO return cannula and a side arm in fluid communication with the guidewire lumen of the elongated shaft.

13. The method of claim 12 , further comprising:

removing the guidewire via the guidewire lumen of the elongated shaft and the side arm; and

inserting a stylet within the guidewire lumen of the elongated shaft via the side arm to thereby prevent blood from entering the guidewire lumen of the elongated shaft during operation.

14. The method of claim 12 , further comprising:

removing the guidewire via the guidewire lumen of the elongated shaft and the side arm; and

coupling an end cap to an inlet of the side arm to thereby prevent blood from entering the guidewire lumen of the elongated shaft during operation.

15. The method of claim 1 , further comprising:

disposing the extension cannula within a sheath,

wherein advancing the distal region of the extension cannula within the patient's vasculature comprises advancing the distal region of the extension cannula within the patient's vasculature while the extension cannula is disposed within the sheath.

16. The method of claim 15 , wherein the sheath comprises a peel-away introducer disposed on at least a portion of the extension cannula, and wherein advancing the distal region of the extension cannula within the patient's vasculature while the extension cannula is disposed within the sheath comprises advancing the distal region of the extension cannula within the patient's vasculature such that a proximal end of the peel-away introducer remains external to the patient, the method further comprising:

retracting the peel-away introducer relative to the extension cannula and peeling the peel-away introducer off of the extension cannula; and

advancing the ECMO return cannula into the patient's vasculature such that the extension cannula extends from the location proximal to the patient's renal vessels to the location beyond the patient's renal vessels.

17. The method of claim 16 , wherein the peel-away introducer comprises a diameter that is at most equal to a diameter of the extension cannula.

18. The method of claim 1 , wherein transitioning the extension cannula from the collapsed insertion state to the expanded deployed state comprises transitioning a support extending circumferentially along the distal region of the extension cannula from a collapsed delivery state to an expanded deployed state.

19. The method of claim 18 , wherein transitioning the extension cannula from the collapsed insertion state to the expanded deployed state comprises transitioning a plurality of connection structures extending from a distal end of the extension cannula to the support from a collapsed delivery state to an expanded deployed state.

20. The method of claim 1 , further comprising measuring at least one of pressure, flow, or oxygen saturation within the patient's vasculature via one or more sensors disposed at the distal region of the extension cannula.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 24, 2023
From: KAPUR, NAVIN K.
To: TUFTS MEDICAL CENTER, INC.
Reel/Frame 064699/0775 →
Continuity (5)
Continuation 18151982 · Jan 9, 2023
Continuation In Part 17663205 · May 12, 2022
Continuation In Part PCTUS2021025461 · Apr 1, 2021
Continuation In Part 16840284 · Apr 3, 2020
Related Publication 20230398279A1 · Dec 14, 2023
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