Transformable dual lumen cannula into a single lumen cannula and methods of use

Inventors: Dagi Ben-Noon (Burgata, IL); Abraham Shabtay (Tel-Aviv, IL); Adi Rizansky Nir (Herzlyia, IL)

Assignee: Inspira-Technologies OXY B.H.N.LTD.

A61M25/003 A61M1/1698 A61M25/0028 A61M25/0029 A61M25/02 A61M25/0637 A61M39/105 A61M2025/0286 A61M2205/70

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Quick Facts

Patent No.: US 12708742
App. No.: 18/062,610
Granted: Aug 18, 2026
Kind: B2

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Abstract

The present invention is directed to a dual lumen cannula configured to be inserted into a patient's body as simple as a single lumen cannula. The dual lumen cannula includes at least one inner lumen configured to be inserted into an outer lumen and connected via an inner lumen connection unit and an outer unit connection unit. Embodiments of the presenting invention further allow for the connection of at least one flow router to the other end of the inner lumen connection unit. When installed, the outer lumen is first inserted into the patient's body, followed by the insertion of the inner lumen into the outer lumen of the already cannulated patient until the inner lumen connector unit is in coupling contact with the outer lumen connector unit. The invention is also directed to a transformable dual lumen cannula into a single lumen cannula and vice versa that allow patients that are first being treated by low flow approach to be treated by high flow approach.

Claims (36)

1 . A cannula configured to transform between a dual lumen cannula into a single lumen cannula, or configured to transform between the single lumen cannula into the dual lumen cannula, in a patient's vascular system in real time, in vivo, the cannula comprising:

at least one inner lumen having at least two ends, an inner lumen proximal end and an inner lumen distal end, a hollow intermediate extent between said at least two ends having one or more openings at the inner lumen distal end, and at least one inner lumen connector unit and

at least one flow router at the inner lumen proximal end, wherein said at least one inner lumen is configured to be inserted into an at least one outer lumen;

said at least one outer lumen having at least two outer ends, an outer lumen proximal end and an outer lumen distal end, a hollow outer intermediate extent between said at least two outer ends having one or more openings, said hollow outer intermediate extent further comprising one or more openings at the outer lumen distal end, and at least one outer lumen connector unit at the outer lumen proximal end, wherein said outer lumen is configured to receive the at least one inner lumen;

at least one single flow connector adapted to be connected to said at least one outer lumen connector unit at the outer lumen proximal end having a single channel flow pattern; and

at least one dual flow connector adapted to be connected to said at least one inner lumen connector unit at the inner lumen proximal end having a dual channel flow pattern;

wherein upon use as the single lumen cannula, said at least one outer lumen is configured to be in coupling contact with said at least one single flow connector when said at least one outer lumen has been installed in a patient;

wherein upon use as the dual lumen cannula, said at least one inner lumen is configured to be inserted into said at least one outer lumen in vivo until said inner lumen proximal end of said at least one inner lumen connector unit is in coupling contact with said at least one outer lumen connector unit, and a proximal end of said at least one inner lumen connector unit is configured to be in coupling contact with said at least one dual flow connector after said at least one outer lumen has been installed in the patient.

2 . The cannula of claim 1 , wherein said hollow intermediate extent of the at least one inner lumen further comprises one or more holes located between the outer lumen distal end and a proximal end of the at least one outer lumen, and within a region of the at least one inner lumen which is within the at least one outer lumen when assembled.

3 . The cannula of claim 1 , wherein said at least one outer lumen further comprises a narrow area at its distal end for centralizing the position of the at least one inner lumen toward a target area.

4 . The cannula of claim 1 , wherein said one or more openings on the hollow outer intermediate extent of the at least one outer lumen are at least one drainage opening.

5 . The cannula of claim 1 , wherein upon connection of said at least one outer lumen connector unit to said at least one inner lumen connector unit, the at least one inner lumen connector unit provides a flow path from the at least one flow router to both said at least one outer lumen and said at least one inner lumen.

6 . The cannula of claim 1 , wherein said at least one flow router further comprises an inlet port for connecting to one or more connector tubing connected to at least one medical device.

7 . The cannula of claim 1 , wherein said at least one outer lumen further comprises at least one suturing element that allows fixating the at least one outer lumen to the patient's body once it is cannulated.

8 . The cannula of claim 1 , wherein said at least one inner lumen or said at least one outer lumen further comprises one or more calibration marks.

9 . The cannula of claim 1 , wherein said at least one flow router further comprises a first internal flow channel position connection area from the at least one outer lumen through the at least one outer lumen connector unit then at least one inner lumen connector unit to the medical device.

10 . The cannula of claim 9 , wherein said at least one flow router further comprises a second internal flow channel from the medical device through the at least one inner lumen connector unit to the at least one inner lumen.

11 . The cannula of claim 9 , wherein the flow is reversed such that said first internal flow channel provides a flow path from the medical device through the at least one inner lumen connector unit to the at least one outer lumen connector unit, then to the outer lumen.

12 . The cannula of claim 9 , wherein the flow is reversed such that said second internal flow channel provides a flow path from the at least one inner lumen through the at least one inner lumen connector unit to the medical device.

13 . The cannula of claim 1 , wherein said at least one outer lumen and said at least one outer lumen connector unit are formed as a single piece.

14 . The cannula of claim 1 , wherein said at least one inner lumen connector unit further comprises a vertical separating wall and chambers for creating a separate flow channel via one or more lumen opening to the at least one inner lumen and a separate outer flow channel to the at least one outer lumen through the at least one outer lumen connector unit.

15 . A process for installing a single lumen cannula in a patient and transforming said single lumen cannula into a dual lumen cannula, in real time, in vivo, the process comprising:

inserting an outer lumen into a patient's vascular system through use of an introducer, and optionally a guidewire, drawn through the outer lumen up to its distal end;

withdrawing the introducer and guidewire causing a small vacuum to form in the outer lumen, which is back filled with blood;

connecting at least one single flow connector to said outer lumen for use of said outer lumen as the single lumen cannula, such that said outer lumen is in coupling contact with said at least one single flow connector, and after said outer lumen has been installed in the patient;

converting said single lumen cannula to said dual lumen cannula by priming a inner lumen through use of a priming cap connected to a priming system, whereupon following completion of the priming, the priming cap is removed;

removing said at least one single flow connector from said outer lumen;

inserting said inner lumen within said outer lumen until an inner lumen connector unit fastens to an outer lumen connector unit;

connecting at least one dual flow connector to a proximal end of said inner lumen until said inner lumen connector unit is in coupling contact with said at least one dual flow connector, and after said outer lumen has been installed in the patient.

16 . The process of claim 15 , wherein said outer lumen is sutured to a skin of the patient by stitching regular sutures through a butterfly.

17 . The process of claim 15 , further comprising connecting at least one flow router to said inner lumen connector unit.

18 . The process of claim 17 , wherein one or more medical devices are connected to said at least one flow router.

19 . A process for converting the dual lumen cannula of claim 17 into the single lumen cannula in the patient, in real time, in vivo, the process comprising:

decoupling and removing said at least one dual flow connector and said inner lumen from a proximal end of said outer lumen; and

20 . The process of claim 19 , wherein upon converting said dual lumen cannula into the single lumen cannula, a second single lumen cannula is installed in the patient.