Single expandable double lumen cannula assembly for veno-venous ECMO
First Claim
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1. A system for mixing a fluid into a bloodstream of a body, comprising:
- a. a drainage cannula adapted to be inserted through both a superior vena cava of a heart of the body and an inferior vena cava of the heart, the drainage cannula having a first opening to receive blood from a superior vena cava blood flow and a second opening to receive blood from an inferior vena cava blood flow;
b. an infusion cannula adapted to be inserted into the bloodstream downstream of both the superior vena cava and inferior vena cava;
the drainage cannula and the infusion cannula being coupled as a single cannula assembly with at least two lumen, one lumen being the drainage cannula and the other lumen being the infusion cannula;
c. a septum coupled between the lumen to fluidicly separate the lumen along at least a portion of a length of each lumen and adapted to flex between the two lumen to vary a cross-sectional flow area of at least one of the lumen;
d. a pump coupled to the drainage cannula and the infusion cannula;
e. a mixing unit coupled to the pump and adapted to mix the fluid into the bloodstream of the body; and
f. an atraumatic introducer coupled to the cannula assembly and sized larger than a cross-sectional dimension of at least one of the lumen and adapted to pass through such lumen and cause the septum to flex toward another lumen to allow passage of the introducer.
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Abstract
The present invention provides an apparatus, system, and method of use of a simple, less invasive, self-expandable percutaneous double lumen cannula assembly for VV ECMO that overcomes the limitations and obstacles of the techniques described above. The present invention achieves near theoretical total venous blood drainage, total extracorporeal gas exchange, and prevents recirculation and multiple cannulation, thereby simplifying VV ECMO, decreasing surgical and blood trauma, and expanding its application.
41 Citations
49 Claims
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1. A system for mixing a fluid into a bloodstream of a body, comprising:
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a. a drainage cannula adapted to be inserted through both a superior vena cava of a heart of the body and an inferior vena cava of the heart, the drainage cannula having a first opening to receive blood from a superior vena cava blood flow and a second opening to receive blood from an inferior vena cava blood flow; b. an infusion cannula adapted to be inserted into the bloodstream downstream of both the superior vena cava and inferior vena cava;
the drainage cannula and the infusion cannula being coupled as a single cannula assembly with at least two lumen, one lumen being the drainage cannula and the other lumen being the infusion cannula;c. a septum coupled between the lumen to fluidicly separate the lumen along at least a portion of a length of each lumen and adapted to flex between the two lumen to vary a cross-sectional flow area of at least one of the lumen; d. a pump coupled to the drainage cannula and the infusion cannula; e. a mixing unit coupled to the pump and adapted to mix the fluid into the bloodstream of the body; and f. an atraumatic introducer coupled to the cannula assembly and sized larger than a cross-sectional dimension of at least one of the lumen and adapted to pass through such lumen and cause the septum to flex toward another lumen to allow passage of the introducer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A system for mixing a fluid into a bloodstream of a body, comprising:
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a. a drainage means for discharging blood from both a superior vena cava of a heart of the body and an inferior vena cava of the heart; b. an infusion means for infusing the fluid into the bloodstream downstream of both the superior vena cava and inferior vena cava, the drainage means and the infusion means being coupled to form a single assembly with at least two lumen, the drainage means comprising a first lumen and the infusion means comprising a second lumen; c. a septum coupled between the lumen to fluidicly separate the lumen along at least a portion of a length of each lumen and adapted to flex between the two lumen to vary a cross-sectional flow area of at least one of the lumen; d. a pump coupled to the drainage means and the infusion means; e. a mixing unit coupled to the pump and adapted to mix the fluid into the bloodstream of the body; and f. an atraumatic introducer coupled to the assembly of the drainage means and the infusion means and sized larger than a cross-sectional dimension of at least one of the lumen and adapted to pass through such lumen and cause the septum to flex toward another lumen to allow passage of the introducer. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A method of perfusing a fluid into a bloodstream of a body, comprising:
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a. introducing an atraumatic introducer into a bloodstream of the body, the introducer being coupled to a single cannula assembly having a drainage cannula forming a first lumen and an infusion cannula forming a second lumen, and the first and second lumen being fluidicly separated by a septum coupled between the lumen along at least a portion of a length of each lumen and adapted to flex between the two lumen to vary a cross-sectional flow area of at least one of the lumen, the introducer being sized larger than a cross-sectional dimension of at least one of the lumen and adapted to pass through such lumen and cause the septum to flex toward another lumen to allow passage of the introducer; b. discharging blood through the common drainage cannula from a superior vena cava of a heart of the body and an inferior vena cava of the heart; c. pumping the blood through a mixing unit to combine a fluid with the blood; and d. infusing the fluid with the blood into the body through the infusion cannula. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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45. A system for mixing a fluid into a bloodstream of a body, comprising:
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a. a drainage cannula adapted to be inserted through both a superior vena cava of a heart of the body and an inferior vena cava of the heart, the drainage cannula having a first opening to receive blood from a superior vena cava blood flow and a second opening to receive blood from an inferior vena cava blood flow; b. an infusion cannula adapted to be inserted into the bloodstream downstream of both the superior vena cava and inferior vena cava;
the drainage cannula and the infusion cannula being coupled as a single cannula assembly with at least two lumen, one lumen being the drainage cannula and the other lumen being the infusion cannula;c. a septum coupled between the lumen to fluidicly separate the lumen along at least a portion of a length of each lumen and adapted to flex between the two lumen to vary a cross-sectional flow area of at least one of the lumen; and d. an atraumatic introducer coupled to the cannula assembly and sized larger than a cross-sectional dimension of at least one of the lumen and adapted to pass through such lumen and cause the septum to flex toward another lumen to allow passage of the introducer. - View Dependent Claims (46, 47)
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48. A system for mixing a fluid into a bloodstream of a body, comprising:
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a. a drainage cannula adapted to be inserted through both a superior vena cava of a heart of the body and an inferior vena cava of the heart, the drainage cannula having a first opening to receive blood from a superior vena cava blood flow and a second opening to receive blood from an inferior vena cava blood flow; b. an infusion cannula adapted to be inserted into the bloodstream downstream of both the superior vena cava and inferior vena cava;
the drainage cannula and the infusion cannula being coupled as a single cannula assembly with at least two lumen, one lumen being the drainage cannula and the other lumen being the infusion cannula;c. a septum coupled between the lumen to fluidicly separate the lumen along at least a portion of a length of each lumen and adapted to flex upon insertion of an introducer into one of the lumen; d. a pump coupled to the drainage cannula and the infusion cannula; e. a mixing unit coupled to the pump and adapted to mix the fluid into the bloodstream of the body; and f. an atraumatic introducer coupled to the cannula assembly and sized larger than a cross section dimension of at least one of the lumen and adapted to pass through such lumen and cause the septum to flex toward another lumen to allow passage of the introducer. - View Dependent Claims (49)
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Specification