Cannula for Endovascular Blood Circuit Support, Corresponding Assembly, Method and Cannula System
20220280768 · 2022-09-08
Inventors
Cpc classification
A61M60/427
HUMAN NECESSITIES
A61M60/268
HUMAN NECESSITIES
A61M60/274
HUMAN NECESSITIES
A61M1/3613
HUMAN NECESSITIES
A61M60/113
HUMAN NECESSITIES
A61M1/3659
HUMAN NECESSITIES
A61M1/3623
HUMAN NECESSITIES
A61M60/117
HUMAN NECESSITIES
International classification
A61M60/117
HUMAN NECESSITIES
A61M60/113
HUMAN NECESSITIES
A61M60/274
HUMAN NECESSITIES
A61M60/427
HUMAN NECESSITIES
Abstract
Disclosed is a cannula (CA1 to CA7) for endovascular and/or jugular blood circuit support, comprising: —a proximal portion (PP1 to PP6), —a distal portion (DP1 to DP7) that comprises at least one distal opening (DO1 to DO7), —a lumen portion (LP) that extends from the proximal portion (PP1 to PP6) to the at least one distal opening (DO1 to DO7), and—at least one intermediate portion (IP1 to IP7) that is arranged between the proximal portion (PP1 to PP6) and the distal portion (DP1 to DP7), wherein the intermediate portion (IP1 to IP7) comprises at least one intermediate opening (IO1 to IO7), and wherein the intermediate portion (IP1 to IP7) is configured such that more than 90 volume percent of the fluid flow are drained from the intermediate opening (IO1 to IO7) if a fluid flow within the proximal portion (PP1 to PP6) is directed proximally and such that more than 90 volume percent of the fluid flow are delivered through the at least one distal opening (DO1 to DO7) if a fluid flow within the proximal portion (PP1 to PP6) is directed distally.
Claims
1. Cannula (CA1 to CA7, CA107, CA108, CA109a, CA110a) for endovascular and/or jugular blood circuit support, comprising: a proximal portion (PP1 to PP6), a distal portion (DP1 to DP7) that comprises at least one distal opening (DO1 to DO7), a lumen portion (LP) that extends from the proximal portion (PP1 to PP6) to the at least one distal opening (DO1 to DO7), and at least one intermediate portion (IP1 to IP7) that is arranged between the proximal portion (PP1 to PP6) and the distal portion (DP1 to DP7), wherein the intermediate portion (IP1 to IP7) comprises at least one intermediate opening (IO1 to IO7), wherein the intermediate portion (IP1 to IP7) is configured such that more than 90 volume percent of the fluid flow are drained from the intermediate opening (IO1 to IO7) if a fluid flow within the proximal portion (PP1 to PP6) is directed proximally and such that more than 90 volume percent of the fluid flow are delivered through the at least one distal opening (DO1 to DO7) if a fluid flow within the proximal portion (PP1 to PP6) is directed distally, or b) the intermediate portion (IP109a, IP110a) is configured such that more than 90 volume percent of the fluid flow are drained from the at least one distal opening (DO109a, DO110a) if a fluid flow within the proximal portion (PP109a, PP110a) is directed proximally and such that more than 90 volume percent of the fluid flow are delivered through the intermediate opening (IO109a, IO110a) if a fluid flow within the proximal portion (PP109a, PP110a) is directed distally.
2. Cannula (CA1 to CA7) according to claim 1, wherein the cannula (CA1 to CA7) has one of the following dimensions: a1) a distance between a distal end of the cannula (CA1) and the at least one intermediate opening (IO1) is in the range of 10 cm to 25 cm and a total length of the cannula (CA1) is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA1) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the left atrium (LA) and with blood delivery into the aorta (AO), a2) a distance between a distal end of the cannula (CA2) and the at least one intermediate opening (IO2) is in the range of 5 cm and 12 cm and a total length of the cannula (CA2) is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA2) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the left ventricle (LV) and with blood delivery into the aorta (AO), a3) a distance between a distal end of the cannula (CA3) and an intermediate opening (IO3) is in the range of 22 cm to 35 cm and a total length of cannula (CA3) is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA3) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the right atrium (RA) and with blood delivery into the aorta (AO), a3a) a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 27 cm to 40 cm and a total length of cannula is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a4) a distance between a distal end of the cannula (CA4) and the at least one intermediate opening (IO4) is in the range of 5 cm to 15 cm and a total length of cannula (CA4) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA4) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from right atrium (RA) to aorta (AO) with blood drainage from the right atrium (RA) and with blood delivery into the aorta (AO), or a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 10 cm to 20 cm and a total length of cannula (CA4) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA4) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from right atrium (RA) to aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a4a) a distance between a distal end of the cannula (CA4a) and the at least one intermediate opening (IO4a) is in the range of 10 cm to 25 cm and a total length of cannula (CA4a) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA4a) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC) and punctured transcaval from the vena cava (VC) to aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a5) a distance between a distal end of the cannula (CA5) and the at least one intermediate opening (IO5) is in the range of 10 cm to 25 cm and a total length of cannula (CA5) is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA5) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle at least to aorta (AO) with blood drainage from the left ventricle (LV) and with blood delivery into the aorta (AO), a6) a distance between a distal end of the cannula (CA6) and the at least one intermediate opening (IO6) is in the range of 15 cm to 25 cm or in the range of 10 cm to 25 cm and a total length of cannula (CA6) is in the range of 55 cm and 85 cm, preferably 65 cm, wherein the cannula (CA6) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to aorta (AO) with blood drainage from the right atrium (RA) and with blood delivery into the aorta (AO), or a distance between a distal end of the cannula (CA6) and the at least one intermediate opening (IO6) is in the range of 10 cm to 25 cm and a total length of cannula (CA6) is in the range of 55 cm and 85 cm, preferably 65 cm, wherein the cannula (CA6) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to aorta (AO) with blood drainage from the right ventricle (RV) and with blood delivery into the aorta (AO), or a distance between a distal end of the cannula (CA6) and the at least one intermediate opening (IO6) is in the range of 20 to 40 cm and a total length of cannula (CA6) is in the range of 55 cm and 85 cm, preferably 65 cm, wherein the cannula (CA6) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to aorta (AO) with blood drainage from vena cava (VC) and with blood delivery into the aorta (AO), a7) a distance between a distal end of the cannula (CA7) and the at least one intermediate opening (IO7) is in the range of 15 cm to 25 cm and a total length of the cannula (CA7) in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA7) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the right atrium (RA) and with blood delivery into the pulmonary artery (PA), a8) a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 10 cm and 20 cm and a total length of the cannula is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the right ventricle (RV) and with blood delivery into the pulmonary artery (PA), a9) a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 25 cm and 35 cm and a total length of cannula is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a10) a distance between a distal end of the cannula (CA10) and the at least one intermediate opening (IO10) is in the range of 5 cm to 15 cm and a total length of cannula (CA10) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA10) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from the right atrium (RA) to pulmonary artery (PA) with blood drainage from the right atrium (RA) and with blood delivery into the pulmonary artery (PA), or a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 10 cm to 20 cm and a total length of cannula is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from the right atrium (RA) to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a10a) a distance between a distal end of the cannula (CA10a) and the at least one intermediate opening (IO10a) is in the range of 10 cm to 20 cm and a total length of cannula (CA10a) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA10a) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC) and punctured transcaval from the vena cava (VC) to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a11a) a distance between a distal end of the cannula (CA107) and the at least one intermediate opening (IO107) is in the range of 5 cm to 30 cm and a total length of cannula (CA107) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA107, CA108) is adapted to be inserted endovascularly, preferably jugular, through superior vena cava (VC), through right atrium (RA) and inferior vena cava (IVC) with blood drainage from at least one renal vein (rV1, rV2) or from both renal veins (rV1, rV2) and with blood delivery into the right atrium (RA).
3. Cannula (CA1 to CA7) according to claim 2, wherein the maximal outer diameter of the cannula (CA1 to CA7) is in the range of 25 F to 36 F or preferably in the range of 29 F to 33 F.
4. Cannula (CA1 to CA7) according to claim 1, wherein the cannula (CA1 to CA7) has one of the following dimensions: a1) a distance between a distal end of the cannula (CA1) and the at least one intermediate opening (IO1) is in the range of 10 cm to 25 cm, wherein the cannula (CA1) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the left atrium (LA) and with blood delivery into the aorta (AO), a2) a distance between a distal end of the cannula (CA2) and the at least one intermediate opening (IO2) is in the range of 5 cm and 12 cm, wherein the cannula (CA2) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the left ventricle (LV) and with blood delivery into the aorta (AO), a3) a distance between a distal end of the cannula (CA3) and the at least one intermediate opening (IO3) is in the range of 22 cm to 35 cm, wherein the cannula (CA3) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the right atrium (RA) and with blood delivery into the aorta (AO), a3a) a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 27 cm to 40 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a4) a distance between a distal end of the cannula (CA4) and the at least one intermediate opening (IO4) is in the range of 5 cm to 15 cm, wherein the cannula (CA4) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from the right atrium (RA) to aorta (AO) with blood drainage from the right atrium (RA) and with blood delivery into the aorta (AO), or a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 10 cm to 20 cm, wherein the cannula (CA4) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from right atrium (RA) to aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a4a) a distance between a distal end of the cannula (CA4a) and the at least one intermediate opening (IO4a) is in the range of 10 cm to 25 cm, wherein the cannula (CA4a) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC) and punctured transcaval from the vena cava (VC) to aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a5) a distance between a distal end of the cannula (CA5) and the at least one intermediate opening (IO5) is in the range of 10 cm to 25 cm, wherein the cannula (CA5) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle at least to aorta (AO) with blood drainage from the left ventricle (LV) and with blood delivery into the aorta (AO), a6) a distance between a distal end of the cannula (CA6) and the at least one intermediate opening (IO6) is in the range of 15 cm to 25 cm, wherein the cannula (CA6) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to aorta (AO) with blood drainage from the right atrium (RA) and with blood delivery into the aorta (AO), or a distance between a distal end of the cannula (CA6) and the at least one intermediate opening (IO6) is in the range of 10 cm to 20 cm, wherein the cannula (CA6) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to aorta (AO) with blood drainage from the right ventricle (RV) and with blood delivery into the aorta (AO), or a distance between a distal end of the cannula (CA6) and the at least one intermediate opening (IO6) is in the range of 20 to 40 cm, wherein the cannula (CA6) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to aorta (AO) with blood drainage from vena cava (VC) and with blood delivery into the aorta (AO), a7) a distance between a distal end of the cannula (CA7) and the at least one intermediate opening (IO7) is in the range of 15 cm to 25 cm, wherein the cannula (CA7) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the right atrium (RA) and with blood delivery into the pulmonary artery (PA), a8) a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 10 cm and 20 cm, wherein the cannula (CA7) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the right ventricle (RV) and with blood delivery into the pulmonary artery (PA), a9) a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 25 cm and 35 cm, wherein the cannula (CA7) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a10) a distance between a distal end of the cannula (CA10) and the at least one intermediate opening (IO10) is in the range of 5 cm to 15 cm, wherein the cannula (CA10) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from the right atrium (RA) to the pulmonary artery (PA) with blood drainage from the right atrium (RA) and with blood delivery into the pulmonary artery (PA), or a distance between a distal end of the cannula and the at least one intermediate opening is in the range of 10 cm to 20 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from the right atrium (RA) to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a10a) a distance between a distal end of the cannula (CA10a) and the at least one intermediate opening (IO10a) is in the range of 10 cm to 20 cm, wherein the cannula (CA10a) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC) and punctured transcaval from vena cava (VC) to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a1l a) a distance between a distal end of the cannula (CA107) and the at least one intermediate opening (IO107) is in the range of 5 cm to 30 cm, wherein the cannula (CA107, CA108) is adapted to be inserted endovascularly, preferably jugular, through superior vena cava (VC), through right atrium (RA) and inferior vena cava (IVC) with blood drainage from at least one renal vein (rV1, rV2) or from both renal veins (rV1, rV2) and with blood delivery into the right atrium (RA).
5. Cannula (CA1 to CA7) according to claim 4, wherein the maximal outer diameter of the cannula (CA1 to CA7) is in the range of 25 F to 36 F or preferably in the range of 29 F to 33 F.
6. Cannula (CA1 to CA7) according to claim 1, wherein the cannula (CA1 to CA7) has one of the following dimensions: a1) a total length of cannula (CA1) is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA1) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the left atrium (LA) and with blood delivery into the aorta (AO), a2) a total length of cannula (CA2) is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA2) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the left ventricle (LV) and with blood delivery into the aorta (AO), a3) a total length of cannula (CA3) is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA3) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the right atrium (RA) and with blood delivery into the aorta (AO), a3a) a total length of cannula is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least into aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a4) a total length of cannula (CA4) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA4) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from the right atrium (RA) to aorta (AO) with blood drainage from the right atrium (RA) and with blood delivery into the aorta (AO), a total length of cannula (CA4) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA4) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from right atrium (RA) to aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a4a) a total length of cannula (CA4a) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA4a) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC) and punctured transcaval from the vena cava (VC) to aorta (AO) with blood drainage from the vena cava (VC) and with blood delivery into the aorta (AO), a5) a total length of cannula (CA5) in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA5) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to aorta (AO) with blood drainage from the left ventricle (LV) and with blood delivery into the aorta (AO), a6) a total length of cannula (CA6) is in the range of 55 cm and 85 cm, preferably 65 cm, wherein the cannula (CA6) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to aorta (AO) with blood drainage from the right atrium (RA) or from the right ventricle (RV) or from the vena cava (VC) and with blood delivery into the aorta (AO), a7) a total length of cannula (CA7) in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula (CA7) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the right atrium (RA) and with blood delivery into the pulmonary artery (PA), a8) a total length of cannula is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the right ventricle (RV) and with blood delivery into the pulmonary artery (PA), a9) a total length of cannula is in the range of 55 cm to 85 cm, preferably 65 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a10) a total length of cannula (CA10) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA10) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from the right atrium (RA) to the pulmonary artery (PA) with blood drainage from the right atrium (RA) and with blood delivery into the pulmonary artery (PA), or a total length of cannula is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC), right atrium (RA) and punctured transcaval from the right atrium (RA) to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a10a) a total length of cannula (CA10a) is in the range of 45 cm to 65 cm, preferably 55 cm, wherein the cannula (CA10a) is adapted to be inserted endovascularly, preferably jugular, through vena cava (VC) and punctured transcaval from vena cava (VC) to pulmonary artery (PA) with blood drainage from the vena cava (VC) and with blood delivery into the pulmonary artery (PA), a11a) a total length of cannula (CA107) is in the range of 35 cm to 65 cm, preferably 55 cm, wherein the cannula (CA107, CA108) is adapted to be inserted endovascularly, preferably jugular, through superior vena cava (VC), through right atrium (RA) and inferior vena cava (IVC) with blood drainage from at least one renal vein (rV1, rV2) or from both renal veins (rV1, rV2) and with blood delivery into the right atrium (RA).
7. Cannula (CA1 to CA7) according to claim 6, wherein the maximal outer diameter of the cannula (CA1 to CA7) is in the range of 25 F to 36 F or preferably in the range of 29 F to 33 F.
8. Cannula (CA1 to CA7) according to one of the claims 1 to 7, wherein the cannula (CA1 to CA7) comprises at least one valve for directing the fluid flows depending on the direction of the fluid flow in the proximal portion (PP1 to PP7), preferably a movable and/or pivotable valve, and/or wherein the at least one valve is arranged at the at least one intermediate opening (IO1 to IO7).
9. Cannula (CA1 to CA7) according to claim 8, wherein the valve comprises one of the following elements: b1) a curved plate-shaped member that is mounted pivotable around an axis that is arranged transversally to a longitudinal axis of the cannula (CA1 to CA7), wherein the curved member is mounted at the intermediate opening (IO1 to IO7), b2) a curved plate-shaped member that is curved along a first curvature line and that comprises a deflector element that is curved along a second curvature line that extends within an angle of 80 to 100 degrees relative to the first curvature line, preferably with an angle of 90 degrees, b3) a wedge shaped element, preferably comprising a first wedge shaped portion and a second wedge shaped portion, wherein preferably both wedge shaped portion point in opposite directions with regard to each other, and wherein the first wedge shaped portion has as smaller wedge angle compared to the wedge angle of the second wedge shaped portion, preferably at least 5 degrees smaller or at least 10 degrees smaller.
10. Cannula (CA1 to CA7) according to one of the claims 1 to 9, wherein the cannula is adapted to deliver blood with a flow rate within the range of 2.5 liter per minute to 4 liter per minute or within the range of 3 liter per minute to 3.5 liter per minute.
11. Cannula (CA1 to CA7) according to one of the claims 1 to 10, wherein the cannula (CA1 to CA7) comprises at least one expandable arrangement at the distal portion (DP1 to DP7), preferably a cage arrangement or a balloon.
12. Cannula (CA1 to CA7) according to one of the claims 1 to 10, wherein the cannula (CA1 to CA7) comprises at least one expandable arrangement at the intermediate portion (IP1 to IP7), preferably a cage arrangement or a balloon.
13. Cannula (CA1 to CA7) according to one of the claims 1 to 10, wherein the cannula (CA1 to CA7) comprises at least one first expandable arrangement at the distal portion (DP1 to DP7), preferably a first cage arrangement or a first balloon, and wherein the cannula comprises at least one second expandable arrangement at the intermediate portion (IP1 to IP7), preferably a cage arrangement or a balloon.
14. Cannula (CA1 to CA7) according to one of the claims 1 to 13, wherein the wall thickness of the cannula (CA1 to CA7) is within the range of 0.1 mm to 0.5 mm, and/or wherein the wall of the cannula (CA1 to CA7) is reinforced by wires (CA1 to CA7), especially by metal wires, or by plastic fibers or by glass fibers.
15. Cannula (CA1 to CA7) according to one of the claims 1 to 14, wherein the inner wall of the cannula comprises at least one structure that effects a rotation of the fluid flow within the cannula (CA1 to CA7), preferably at least one helically wound protrusion and/or recess.
16. Assembly (A3, A4, A6) for endovascular blood circuit support, comprising: at least one cannula (CA1 to CA7) according to one of the claims 1 to 15, at least one variable volume reservoir (MP3, MP4, MP6) that has an aspiration phase for drawing fluid into the variable volume reservoir (MP3, MP4, MP6) and that has an expulsion phase for pressing the fluid out of the variable volume reservoir (MP3, MP4, MP6) or a pump that may be controlled to drive a fluid flow within the cannula (CA1 to CA7) into two different directions, wherein the cannula (CA1 to CA7) is coupled or is adapted to be coupled directly to the at least one variable volume reservoir (MP3, MP4, MP6) or to the pump or wherein the assembly comprises at least one coupling conduit that is coupled or that is adapted to be fluidically coupled between the at least one cannula (CA1 to CA7) and the at least one variable volume reservoir (MP3, MP4, MP6) or the pump.
17. Assembly according to claim 16, wherein the cannula (CA1 to CA7) and the variable volume reservoir (MP3, MP4, MP6) or the pump form separate devices that may be coupled with each other to form a fluid circuit.
18. Assembly (A3, A4, A6) according to one of the claims 16 or 17, wherein the variable volume reservoir (MP3, MP4, MP6) comprises at least one membrane (M), preferably a flat membrane (M) or a toroidal membrane.
19. Assembly (A3, A4, A6) according to one of the claims 16 to 19, wherein the variable volume reservoir (MP3, MP4, MP6) comprises two ports for blood transport, preferably at the same side of the membrane (M) or of a membrane (M).
20. Assembly (A3, A4, A6) according to one of the claims 16 to 18, wherein the variable volume reservoir (MP3, MP4, MP6) comprises only one port for blood transport that is connected with the cannula (CA1 to CA7).
21. Assembly (A3, A4, A6) according to one of the claims 16 to 20, comprising at least one oxygenator device (OXY3, OXY4, OXY6).
22. Assembly (A3, A4, A6) according to claim 21, wherein the oxygenator device (OXY3, OXY4, OXY6) is adapted to be inserted or is inserted fluidically within one secondary branch of a fluid circuit only, and wherein the fluid flow flows through the oxygenator device (OXY3, OXY4, OXY6) only in one direction (Dir3b, Dir4b, Dir6b).
23. Assembly (A3, A4, A6) according to claim 21, wherein the oxygenator (OXY3, OXY4, OXY6) is adapted to be inserted or is inserted into a main branch of a fluid circuit between the cannula (CA1 to CA7) and the variable volume reservoir (MP3, MP4, MP6), and wherein the fluid flow flows through the oxygenator device (OXY3, OXY4, OXY6) in two directions.
24. Assembly (A3, A4, A6) according to one of the claims 16 to 23, wherein the variable volume reservoir (MP3, MP4, MP6) is adapted to be used with an IABP (Intra-Aortic Balloon Pump) console that is not part of the assembly (A3, A4, A6) or wherein the assembly (A3, A4, A6) comprises a control unit that is able to control the variable volume reservoir (MP3, MP4, MP6) or the pump depending on the heartbeat of a heart and/or on the pulse beat of a pulse of a subject, wherein the beat is detected or measured by at least one sensor.
25. Assembly (A3, A4, A6) according to one of the claims 16 to 24, wherein the variable volume reservoir (MP3, MP4, MP6) has a maximal pump volume equal to or greater of 50 ml or equal to or greater of 60 ml, preferably within the range of 60 ml to 160 ml or most preferably within the range of 80 ml to 120 ml.
26. Method for endovascular blood circuit support, inserting a cannula (CA1 to CA7, CA107, CA108, CA109a, CAI10a) endovascularly through a vessel of a blood circuit, wherein the cannula (CA1 to CA7) comprises: a proximal portion (PP1 to PP7), a distal portion (DP1 to DP7) that comprises at least one distal opening (DO1 to DO7), at least one lumen portion (LP) that extends from the at least one proximal portion (PP1 to PP6) to the at least one distal opening (DO1 to DO7), and at least one intermediate portion (IP1 to IP6) that is arranged between the proximal portion (PP1 to PP6) and the distal portion (DP1 to DP7), wherein the intermediate portion (IP1 to IP6) comprises at least one intermediate opening (IO1 to IO7), and a) wherein the intermediate portion (IP1 to IP6) is configured such that more than 90 volume percent of the fluid flow are drained from the intermediate opening (IO1 to IO7) if a fluid flow within the proximal portion (PP1 to PP6) is directed proximally and such that more than 90 volume percent are delivered through the at least one distal opening (DO1 to DO7) if a fluid flow within the proximal portion (PP1 to PP6) is directed distally, drawing blood mainly from the at least one intermediate opening (IO1 to IO7) during a drainage phase and delivering blood out of the at least one distal opening (DO1 to DO7) during a delivery phase, or b) wherein the intermediate portion (IP109a, IP110a) is configured such that more than 90 volume percent of the fluid flow are drained from the at least one distal opening (DO109a, DO110a) if a fluid flow within the proximal portion (PP109a, PP110a) is directed proximally and such that more than 90 volume percent are delivered through the intermediate opening (I1009a, IO110a) if a fluid flow within the proximal portion (PP1 to PP6) is directed distally, drawing blood mainly from the at least one distal opening (DO109a, DO110a) during a drainage phase and delivering blood out of the at least one intermediate opening (IO109a, IO110a) during a delivery phase.
27. Method according to claim 26, wherein the distal portion (DP1, DP2) of the cannula (CA1, CA2) is inserted endovascularly, preferably jugularly, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least to ascending aorta (aAO), wherein blood is drained into the at least one intermediate opening (IO1) from the left atrium (LA) or wherein blood is drained into the at least one intermediate opening (IO2) from the left ventricle (LV) and wherein blood is delivered out of the at least one distal opening (IO1, IO2) into the aorta (AO).
28. Method according to claim 26, wherein the distal portion (DP3) of the cannula (CA3) is inserted endovascularly, preferably jugularly, through vena cava (VC), right atrium (RA), atrial septum (AS), left atrium (LA), left ventricle (LV) at least to ascending aorta (aAO), wherein blood is drained into the at least one intermediate opening (IO3) from the right atrium (RA) or from the vena cava (VC) and wherein blood is delivered out of the at least one distal opening (DO3) into the aorta (AO), preferably into the ascending aorta (aAO), wherein the blood is oxygenated after it is drained in and before it is delivered out of the cannula (CA3), preferably by at least one extracorporeal oxygenator (OXY3).
29. Method according to claim 26, wherein a) the distal portion (DP4) of the cannula (CA4) is inserted endovascularly, preferably jugularly, through vena cava (VC) and punctured from the vena cava (VC) directly to aorta (AO), wherein blood is drained into the at least one intermediate opening (IO4) from the vena cava (VC) and wherein blood is delivered out of the at least one distal opening (DO4) into the aorta (AO), wherein the blood is oxygenated after it is drained in and before it is delivered out, preferably by at least one extracorporeal oxygenator device (OXY4), or wherein b) the distal portion (DP4) of the cannula (CA4) is inserted endovascularly, preferably jugularly, through vena cava (VC), right atrium (RA) and punctured from the right atrium (RA) directly to aorta (AO), wherein blood is drained into the at least one intermediate opening (IO4) from the vena cava (VC) or from the right atrium (RA) and wherein blood is delivered out of the at least one distal opening (DO4) into the aorta (AO), wherein the blood is oxygenated after it is drained in and before it is delivered out, preferably by at least, or wherein c) the distal portion of the cannula (CA10a) is inserted endovascularly, preferably jugularly, through vena cava (VC) and punctured directly from the vena cava (VC) to a pulmonary artery (PA), wherein blood is drained into the at least one intermediate opening (IO10a) from the vena cava (VC) and wherein blood is delivered out of the at least one distal opening into the pulmonary artery (PA), or wherein d) the distal portion (DP10) of the cannula (CA10) is inserted endovascularly, preferably jugularly, through vena cava (VC), right atrium (RA) and punctured from the right atrium (RA) directly to a pulmonary artery (PA), wherein blood is drained into the at least one intermediate opening (IO10) from the vena cavy (VC) or from the right atrium (RA) and wherein blood is delivered out of the at least one distal opening (DO10) into the pulmonary artery (PA).
30. Method according to claim 26, wherein the distal portion (DP5) of the cannula (CA5) is inserted endovascularly, preferably jugularly, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), left ventricle (LV) at least to ascending aorta (aAO), wherein blood is drained into the at least one intermediate opening (IO5) from the left ventricle (LV) and wherein blood is delivered out of the at least one distal opening (IO5) into the aorta (AO).
31. Method according to claim 26, wherein the distal portion (DP6) of the cannula (CA6) is inserted endovascularly, preferably jugularly, through vena cava (VC), right atrium (RA), right ventricle (RV), ventricle septum (VS), the ventricle (LV) at least to ascending aorta (aAO), wherein blood is drained into the at least one intermediate opening (IO6) from the vena cava (VC) or from the right atrium (RA) or from the right ventricle (RV) and wherein blood is delivered out of the at least one distal opening (DO6) into the aorta (AO), wherein the blood is oxygenated after it is drained in and before it is delivered out, preferably by at least one extracorporeal oxygenator device (OXY6).
32. Method according to claim 26, wherein the distal portion (DP7) of the cannula (CA7) is inserted endovascularly, preferably jugularly, through vena cava (VC), right atrium (RA), right ventricle (RV) at least to main pulmonary artery (PA), wherein blood is drained into the at least one intermediate opening (IO7) from the vena cava (VC) or from the right atrium (RA) or from the right ventricle (RV) and wherein blood is delivered out of the at least one distal opening (DO7) into the pulmonary artery (PA).
33. Method according to one of the claims 26 to 32, comprising: coupling the proximal portion (PP1 to PP11) of the cannula (CA1 to CA1 1) to a variable volume reservoir (MP3, MP4, MP6) that may perform the aspiration phase for drawing fluid into the reservoir (MP3, MP4, MP6) and that may perform the expulsion phase for pressing the fluid out of the reservoir (MP3, MP4, MP6) or to a pump.
34. Method according to claim 33, wherein a control unit is used that is able to control the variable volume reservoir (MP3, MP4, MP6) or the pump depending on the heartbeat of a heart (H) and/or on pulse beat of a subject, wherein the beat is detected or measured by at least one sensor.
35. Method according to claim 34, wherein the control unit controls the variable volume reservoir (MP3, MP4, MP6) or the pump such that every heartbeat, preferably every beat of the left ventricle (LV) blood is delivered into a body (IO0) of a subject.
36. Method according to claim 34, wherein the control unit controls the variable volume reservoir (MP3, MP4, MP6) or the pump such that every second heartbeat, preferably every second beat of the left ventricle (LV) blood is delivered into a body (IO0) of a subject.
37. Method according to one of the claims 26 to 36, wherein the cannula (CA1 to CA7) is inserted endovascularly, preferably jugular, through a septum of the heart (H).
38. Method according to claim 37, wherein the cannula (CA1 to CA7) is punctured through the atrial septum (AS) and/or inserted.
39. Method according to claim 37, wherein the cannula (CA1 to CA7) is punctured and/or inserted through the ventricle septum (VS).
40. Method according to one of the claims 26 to 36, wherein the cannula (CA1 to CA7) is inserted endovascularly, preferably jugular, through vena cava (VC) and wherein the cannula (CA1 to CA7) is punctured and/or inserted transcaval from the vena cava (VC) or from right atrium (RA) at least to aorta (AO) or into a pulmonary artery (PA).
41. Method according to one of the claims 26 to 40, wherein a maximal outer diameter of the cannula (CA1 to CA7) is in the range of 25 Fr to 36 Fr or, preferably, in the range of 29 Fr to 33 Fr.
42. Method according to one of the claims 26 to 41, wherein a cannula (CA1 to CA7) according to one of the claims 1 to 15 is used and/or wherein an assembly (A3, A4, A6) according to one of the claims 16 to 25 is used.
43. Method according to claim 26, wherein the distal portion of the bidirectional cannula (CA107, CA108) is inserted endovascularly, preferably jugularly, through superior vena cava (SVC), right atrium (RA) and inferior vena cava (IVC) at least to or to a location which has a distance to the junction of the renal veins (rV1, rV2) into the inferior vena cava (IVC) equal to 10 cm or less than 10 cm, equal to 5 cm or less than 5 cm or equal to 2.5 cm or less than 2.5 cm, wherein blood is drained into the at least one distal opening (DO107, DO108) and wherein blood is delivered out of the at least one intermediate opening (IO107, IO108) into the right atrium (RA).
44. Method according to claim 43, wherein the cannula (CA107, CA108) is connected with only one membrane pump (MP7) or with at least two membrane pumps (MP8a, MP8b) which are preferably operated in a parallel operation mode.
45. Method according to claim 26, wherein the cannula (CA109a, CA110a) is a bidirectional cannula (CA109a, CA110a) and wherein the bidirectional cannula (CA109a, CA110a) is inserted through the at least one vessel of the blood circuit within an outer cannula (CA109b, CA110b) which is arranged in the at least one vessel of the blood circuit, wherein the outer cannula (CA109b, CA110b) comprises: a proximal portion (PP109b, PP110b), a distal portion (DP109b, DP110b1, DP110b2) that comprises at least one distal opening (DO109b, D110b1, DO110b2), a lumen portion (LP) that extends from the proximal portion (PP109b, PP110b1, PP110b2) to the at least one distal opening (DO109b, D110b1, DO110b2), and at least one intermediate portion (IPIO9b, IP110b) that is arranged between the proximal portion (PP109b, PP110b) and the distal portion (DPIO9b, DPIIObi, DP110b2), wherein the intermediate portion (IPIO9b, IP110b) of the outer cannula (CAIO9b, CA110b) comprises at least one lateral intermediate opening (IO109b, IO110b) which is configured to allow passage of the distal portion (DP109a, DP110a) of the bidirectional cannula (CA1 to CA7, CA109a, CA110a).
46. Method according to claim 45, wherein before inserting the bidirectional cannula (CA1 to CA7, CA109a, CA110a), the outer cannula (CA109b, CA110b) is inserted through the at least one vessel of the blood circuit, wherein the bidirectional cannula (CA109a, CA110a) is inserted into the outer cannula (CA109b, CA110b) until the distal portion (DP109a, DP110a) of the bidirectional cannula (CA109a, CA110a) extends through the intermediate opening (IO109b, IO110b) of the outer cannula (CA109b, CA110b) and the intermediate opening (IO109a, IO110a) of the bidirectional cannula (CA109a, CA110a) is arranged within the intermediate portion (IP109b, IP110b) of the bidirectional cannula (CA109a, CA110a).
47. Method according to any one of the claims 45 or 46, wherein the distal portion (DP109b) of the outer cannula is (CA109b) is inserted endovascularly, preferably jugularly, through superior vena cava (SVC), right atrium (RA), right ventricle (RV) at least to the pulmonary artery (PA), wherein the distal portion (DP109a) of the bidirectional cannula (CA109a) is inserted into the right atrium (RA) or into the inferior vena cava (IVC), wherein blood is drained into the at least one distal opening (DO109a) of the bidirectional cannula (CA109a) and wherein blood is delivered out of the at least one intermediate opening (IO109a) of the bidirectional cannula (CA109a) and further through the at least one distal opening (DO109b) of the outer cannula (CA109b).
48. Method according to any one of the claims 45 or 46, wherein the distal portion (DP11Gb1, DP110b2) of the outer cannula is (CA110b) is inserted endovascularly, preferably jugularly, through the superior vena cava (SVC), the right atrium (RA) and the atrial septum (AS) to the left atrium (LA) of the heart (H) or to the left ventricle (LV) or at least to the left ventricle (LV), wherein the distal portion (DP110a) of the bidirectional cannula (CA110a) is inserted into the right atrium (RA), through the right ventricle (RV) and at least to the pulmonary artery (PA), wherein blood is drained into the at least one distal opening (DO110) of the bidirectional cannula (CA110a) and wherein blood is delivered out of the at least one intermediate opening (IO110a) of the bidirectional cannula (CA110a) and further through the at least one distal opening (DO110b) of the outer cannula (CA110b).
49. Method according to claim 48, wherein the drained blood is enriched with oxygen and/or depleted from carbon dioxide outside of the body of a patient before it is delivered out of the at least one intermediate opening (IO10 Ga) of the bidirectional cannula (CA110a).
50. Cannula system (CS, CA109a, CA109b; CA110a, CA110b), comprising: a bidirectional cannula (CA109a, CA110a) according to one of the claims 1 to 15, and an outer cannula (CA109b, CA110b), wherein the outer cannula (CA109b, CA110b) comprises: a proximal portion (PP109b, PP110b), a distal portion (DP109b, DP110b1, DP110b2) that comprises at least one distal opening (DO109b, D110b1, DO110b2), a lumen portion that extends from the proximal portion (PP109b, PP110b1, PP110b2) to the at least one distal opening (DO109b, D110b1, DO110b2), and at least one intermediate portion (IP109b, IP110b) that is arranged between the proximal portion (PP109b, PP110b) and the distal portion (DP109b, DP110b1, DP110b2), wherein the intermediate portion (IP109b, IP110b) of the outer cannula (CA109b, CA110b) comprises at least one lateral intermediate opening (IO109b, IO110b) which is configured to allow passage of the distal portion (DP109a, DP110a) of the bidirectional cannula (CA1 to CA7, CA109a, CA110a).
51. Cannula system (CA109a, CA109b; CA110a, CA110b) according to claim 50, wherein the bidirectional cannula (CA109a, CA110a) and the outer cannula (CA109b, CA110b) are configured such that when the bidirectional cannula (CA109a, CA110a) is inserted into the outer cannula (CA109b, CA110b), the distal portion (DP109a) of the bidirectional cannula (CA109a, CA110a) extends through the intermediate opening (IO109b, IO110b) of the outer cannula (CA109b, CA110b) and the intermediate opening (IO109a, IO110a) of the bidirectional cannula (CA109a, CA110a) is arranged within the intermediated portion (IP109b, IP110b) of the outer cannula (CA109b, CA110b) fluidly connected to the distal portion (DP109b, DP110b1, DP110b2) of the outer cannula (CA109b, CA110b).
52. Cannula system (CA109a, CA109b; CA110a, CA110b) according to claim 50 or 51, wherein the bidirectional cannula (CA109a, CA110a) and the outer cannula (CA109b, CA110b) are configured such that when the bidirectional cannula (CA109a, CA110a) is inserted into the outer cannula (CA109b, CA110b), a further lumen portion is defined between an outer surface of the bidirectional cannula (CA109a, CA110a) and an inner surface of the outer cannula (CA109b, CA110b) and wherein the further lumen portion is closed at its distal end and/or at its proximal end.
53. Cannula system (CA109a, CA109b; CA110a, CA110b) according to any one of the claims 50 to 52, wherein the outer diameter of the bidirectional cannula (CA109a, CA110a) is at most 4 French or at most 2 French smaller than the outer diameter of the outer cannula (CA109b, CA110b), preferably in a portion along the longitudinal axis of the bidirectional cannula (CAIO9a, CA110a) between the proximal portion (PP109a, PP110a) of the bidirectional cannula (CA109a, CA110a) and the intermediate portion (IP109a, IP110a) of the bidirectional cannula (CA109a, CA10a) when the bidirectional cannula (CA109a, CA110a) is inserted into the outer cannula (CA109b, CA110b).
54. Cannula system (CA109a, CA109b; CA110a, CA110b) according to any one of the claims 50 to 53, comprising a proximal valve (V9a, V10a), preferably a hemostasis valve, at the proximal portion (PP109b, PP110b) of the outer cannula (CA109b, CA110b), wherein preferably the proximal valve (V9a, V10a) is configured to allow insertion of the bidirectional cannula (CA109a, CA110a) through the proximal hemostatic valve (V9a, V10a) into the outer cannula (CA109b, CA110b).
55. Cannula system (CA109a, CA109b; CA110a, CA110b) according to any one of the claims 50 to 54, comprising an inner intermediate valve (V9b, V10b), preferably a hemostasis valve, at the intermediate portion (IP109b, IP110b) of the outer cannula (CA109b, CA110b), wherein preferably the intermediate valve (V9b, V10b) is configured to allow insertion of the bidirectional cannula (CA109a, CA110a) through the intermediate hemostatic valve (V9a, V10a).
56. Cannula system (CA109a, CA109b; CA110a, CA110b) according to any one of the claims 50 to 55, comprising a valve (V9c, V10c), preferably a hemostasis valve, at the intermediate opening (IO109b, IO110b) of the outer cannula (CA109b, CA110b), wherein preferably the valve (V9c, V10c) at the intermediate opening (IO109b, IO110b) is configured to allow passage of the distal portion (DP109a, DP110a) of the bidirectional cannula (CA109a, CA110a) through the intermediate hemostatic valve (V9c, V10c).
57. Cannula system (CA109a, CA109b; CA110a, CA110b) according to any one of the claims 50 to 56, wherein the outer cannula (CA109b, CA110b) comprises a kink (K) in the intermediate portion (IP109b, IP110b) of the outer cannula (CA109b, CA110b), wherein preferably the kink (K) includes an angle in the range of 80 degrees to 130 degrees, preferably 110 degrees, and wherein the intermediate opening (IO109b, IO110b) of the outer cannula (CA109b, CA110b) is arranged at the kink (K).
58. Cannula system (CAIO9a, CA109b; CA110a, CA110b) according to any one of the claims 50 to 57, wherein the cannula system (CA109a, CA109b; CA110a, CA110b) is adapted to be used for the method according to any one of the claims 45 to 49.
59. Assembly according to any one of the claims 16 to 25, wherein at least one cannula (CA1 to CA7, CA109a, CA110a) is a bidirectional cannula (CA1 to CA7, CA109a, CA111a), the assembly further comprising: an outer cannula (CA109b, CA110b), wherein bidirectional cannula (CA1 to CA7, CA109a, CA110a) is adapted to be inserted into the outer cannula (CA109b, CA110b), wherein the outer cannula (CA109b, CA110b) comprises: a proximal portion (PP109b, PP110b), a distal portion (DP109b, DP110b1, DP110b2) that comprises at least one distal opening (DO109b, D110b1, DO110b2), a lumen portion that extends from the proximal portion (PP109b, PP110b1, PP110b2) to the at least one distal opening (DO109b, D110b1, DO110b2), and at least one intermediate portion (IP109b, IP110b) that is arranged between the proximal portion (PP109b, PP110b) and the distal portion (DP109b, DP110b1, DP110b2), wherein the intermediate portion (IP109b, IP110b) of the outer cannula (CA109b, CA110b) comprises at least one intermediate opening (IO109b, IO110b) which is configured to allow passage of the distal portion (DP109a, DP110a) of the bidirectional cannula (CA1 to CA7, CA109a, CAI10a).
60. Assembly according to one of the claims 16 to 25 or to claim 59, comprising at least two variable volume reservoirs (MP8a, MP8b; MP9a, MP9b).
61. Cannula (CA109b, CA110b), preferably outer cannula (CA109b, CA110b) of a cannula system according to one of the claims 50 to 58 or outer cannula (CA109b, CA110b) of an assembly according to claim 59 or 60, comprising: a proximal portion (PP109b, PP110b), a distal portion (DP109b, DP110b1, DP110b2) that comprises at least one distal opening (DO09b, D110b1, DO110b2), a lumen portion (LP) that extends from the proximal portion (PP109b, PP110b1, PP110b2) to the at least one distal opening (DO09b, D110b1, DO110b2), and at least one intermediate portion (IP109b, IP110b) that is arranged between the proximal portion (PP109b, PP110b) and the distal portion (DP109b, DP110b1, DP110b2), wherein the intermediate portion (IP109b, IP110b) of the outer cannula (CA109b, CA110b) comprises at least one lateral intermediate opening (IO109b, IO110b) which is configured to allow passage of the distal portion (DP109a, DP110a) of a further cannula, preferably of a the bidirectional cannula (CA1 to CA7, CA109a, CA10a).
62. Cannula (CA109b, CA110b) according to claim 61, comprising a kink (K) in the intermediate portion, wherein preferably the kink (K) includes an angle in the range of 80 degrees to 130 degrees, preferably 110 degrees, and wherein the intermediate opening (IO109b, IO110b) of the outer cannula (CA109b, CA110b) is arranged at the kink (K).
63. Cannula (CA109b, CA110b) according to claim 62, wherein the intermediate portion (IP109b, IP110b) comprises a conical portion (ConP) or a decreasing diameter portion which reduces its outer diameter at positions which are more distally than other positions of the decreasing diameter portion, wherein the portion varies in outer diameter by at least 3 French or by at last 4 French or by at least 5 French, preferably by less than 10 French or by less than 8 French.
64. Cannula (CA109b, CA110b) according to any one of the claims 61 to 63, wherein the conical portion (ConP) or the decreasing diameter portion is between the intermediate portion (IP109b, IP110b) of the cannula (CA109b, CA110b) and a distal portion (DP109b, DP110b) of the cannula (CA109b, CA110b), and wherein the distal portion (DP109b, DP110b) comprises an essentially constant diameter portion comprising a length of at least 10 cm or of at least 20 cm, preferably less than 30 cm.
65. Cannula (CA109b, CA110b) according to any one of the claims 61 to 64, wherein the distal portion (DP109b, DP110b) comprises an outer diameter of at least 19 French, of at least 21 French, of at least 23 French, of at least 25 French, of at least 27 French or of at least 29 French, preferably of less than 33 French or less than 31 French.
66. Cannula (CA109b, CA110b) according to any one of the claims 61 to 65, wherein the distance between the proximal portion (PP109b, PP110b) and the intermediate opening (IO109b, IO110b) is at least 20 cm or at least 25 cm, preferably less than 35 cm or less than 30 cm.
67. Cannula (CA109b, CA110b) according to any one of the claims 61 to 66, wherein the cannula (CA109b, CA110b) is adapted to be used as an outer cannula (CA109b, CA110b) in a method according to any one of the claims 45 to 49.
Description
[0207] For a more complete understanding of the presently disclosed concepts and the advantages thereof, reference is now made to the following description in conjunction with the accompanying drawings. The drawings are not drawn to scale. In the drawings the following is shown in:
[0208]
[0209]
[0210]
[0211]
[0212]
[0213]
[0214]
[0215]
[0216]
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[0225] The following valves of heart H are shown in the following
[0230] There are two left pulmonary veins lPV and two right pulmonary veins rPV that extend into left atrium LA of heart H. Blood that is enriched with oxygen comes from lung L into left atrium LA through pulmonary veins PV. This is an exception in that a vein transports blood that comprises more oxygen than blood in a comparable artery. The description of heart H will not be repeated below. However, it is clear that this description is valid for all
[0231] A cannula CA1 comprises: [0232] a proximal portion PP1, [0233] an intermediate portion IP1, and [0234] a distal portion DP1.
[0235] Proximal portion PP1 may be connected to a pump or to a variable volume reservoir. An extracorporeal oxygenator may be inserted between cannula CA1 and the pump or the variable volume reservoir if lung L support is needed. However, left heart H support may be performed without oxygenation if no lung L support is needed, i.e. lung L of the patient is able to deliver enough oxygen for body 100.
[0236] Intermediate portion IP1 may comprise at least one intermediate opening IO1. Intermediate portion IP1 may be configured such that depending on the direction of the blood flow within proximal portion PP1 two different flows are generated within intermediate portion IP1 and within distal portion DP1. A simple solution for this flow selectivity is the usage of a two-way valve or of another valve configuration. Alternatively or additionally, an appropriate fluidically design of cannula CA1 may be used.
[0237] Distal portion DP1 may comprise at least one or exactly one distal opening DO1.
[0238] Optional expandable arrangements EA1a and EA1b may be used around intermediate opening IO1 and/or distal opening DO1. Expandable arrangements EA1a and/or EA1b may fulfill a fixation function and/or other functions as mentioned above.
[0239] If the blood flow within proximal part PP1 is directed proximally, blood is sucked or drained into (see arrow I) intermediate opening IO1 but not or only to a less degree through distal opening DO1. If the blood flow within proximal part PP1 is directed distally, blood is delivered out of distal opening DO1, see arrow O, but not or only to a less degree out of intermediate opening IO1.
[0240] The total length of cannula CA1 may be selected as mentioned above for variant 1. The distance between distal end of cannula CA1 and intermediate opening IO1 may be as mentioned above for variant 1.
[0241] Cannula CA1 may be inserted endovascularly and jugular through vena cava VC, preferably through superior vena cava SVC, right atrium RA, atrial septum AS, left atrium LA, left ventricle LV at least up to ascending aorta aAO, AO with blood drainage through intermediate opening IO1 from left atrium LA and with blood delivery out of distal opening DO1 into aorta AO.
[0242]
[0246] Proximal portion PP2 may be connected to a pump or to a variable volume reservoir. An extracorporeal oxygenator may be inserted between cannula CA2 and the pump or the variable volume reservoir if lung L support is needed. However, left heart H support may be performed without oxygenation if no lung L support is needed, i.e. lung L of the patient is able to deliver enough oxygen for body 100.
[0247] Intermediate portion IP2 may comprise at least one intermediate opening IO2. Intermediate portion IP2 may be configured such that depending on the direction of the blood flow within proximal portion PP2 two different flows are generated within intermediate portion IP2 and within distal portion DP2. A simple solution for this flow selectivity is the usage of a two-way valve or of another valve configuration. Alternatively or additionally an appropriate fluidically design of cannula CA2 may be used.
[0248] Distal portion DP2 may comprise at least one or exactly one distal opening DO2.
[0249] Optional expandable arrangements may be used around intermediate opening IO2 and/or distal opening DO2. The expandable arrangements may fulfill a fixation function and/or other functions as mentioned above.
[0250] If the blood flow within proximal part PP2 is directed proximally, blood is sucked or drained into (see arrow I) intermediate opening IO2 but not or only to a less degree through distal opening DO2. If the blood flow within proximal part PP2 is directed distally, blood is delivered out of distal opening DO2, see arrow O, but not or only to a less degree out of intermediate opening IO2.
[0251] The total length of cannula CA2 may be selected as mentioned above for variant 2. The distance between distal end of cannula CA2 and intermediate opening IO2 may be as mentioned above for variant 2.
[0252] Cannula CA2 may be inserted endovascularly and jugular through vena cava VC, preferably through superior vena cava VC, right atrium RA, atrial septum AS, left atrium LA, left ventricle LV at least up to the ascending aorta aAO, AO with blood drainage through intermediate opening IO2 from left ventricle LV and with blood delivery out of distal opening DO2 into the aorta AO.
[0253]
[0257] Proximal portion PP3 of cannula CA3 may be connected to a pump or to a variable volume reservoir MP3. An extracorporeal oxygenator device OXY3 may be inserted between cannula CA3 and the pump or variable volume reservoir MP3 if lung L support is needed. However, left heart H support may be performed without oxygenation if no lung L support is needed, i.e. the lung L of the patient is able to deliver enough oxygen for body 100.
[0258] Oxygenator OXY3 may be a commercially available oxygenator. A blood filter unit may be used in addition to oxygenator OXY3. Medicaments/drugs or other treatment substances may be given or administered by an optional drug delivery unit that may be included into the fluidic circuitry that is shown in
[0259] An assembly A3 comprises cannula CA3 and variable volume reservoir MP3. Variable volume reservoir MP3 may be arranged as near as possible to body 100 of a patient. Variable volume reservoir MP3 may comprise: [0260] a rigid housing or casing, [0261] a flexible membrane M within the housing, [0262] one port for blood transport or two ports for blood inflow and blood outflow, and [0263] a least one port Po3, that is connected with a fluid reservoir, for instance with a gas reservoir, especially with a helium or with an air reservoir.
[0264] If reservoir MP3 has only one port for blood transport, oxygenator OXY3 may be coupled fluidically between this port and cannula CA3. Alternatively, reservoir MP3 may have two ports for blood transport as shown in
[0265] Port Po3 may be connected to a piston arrangement or to another arrangement that is able to pump gas or another fluid, for instance a liquid, in and out of the housing of reservoir MP3. The piston arrangement or the other arrangement may be controlled depending on the heartbeat of the patient, e.g. based on electrocardiography (ECG) signals or data or other sensor signals or data. Preferably the diastole of left ventricle LV may be used to drain blood into aorta AO. However, other timing schemes are possible as well.
[0266] Intermediate portion IP3 of cannula CA3 may comprise at least one intermediate opening IO3. Intermediate portion IP3 may be configured such that two different flows are generated in intermediate portion IP3 and in distal portion DP3 depending on the direction of the blood flow in proximal portion PP3. A simple solution for this flow selectivity is the usage of a two-way valve or of another valve configuration. Alternatively or additionally an appropriate fluidically design of cannula CA3 may be used.
[0267] Distal portion DP3 may comprise at least one or exactly one distal opening DO3, for instance in combination with an expandable arrangement, e.g. a cage arrangement.
[0268] Optional expandable arrangements may be used around intermediate opening IO3 and/or distal opening DO3. The expandable arrangements may fulfill a fixation function and/or other functions as mentioned above.
[0269] If the blood flow in proximal part PP3 is directed proximally, blood is sucked or drained into (see arrow I) intermediate opening IO3 but not or only to a less degree through distal opening DO3. If the blood flow in proximal part PP3 is directed distally, blood is delivered out of distal opening DO3, see arrow O, but not or only to a less degree out of intermediate opening IO3.
[0270] The total length of cannula CA3 may be as mentioned above for variant 3. The distance between distal end of cannula CA3 and intermediate opening IO3 may be as mentioned above for variant 3.
[0271] Cannula CA3 may be inserted endovascularly and jugular through vena cava VC, right atrium RA, atrial septum AS, left atrium LA, left ventricle LV at least up to the ascending aorta aAO, AO. Blood may be drained through intermediate opening IO3 from right atrium RA if the membrane M increases the volume of reservoir MP3. This blood flows in the first branch along direction Dir3a into reservoir MP3. Blood is delivered out of reservoir MP3 if the membrane M decreases the volume of reservoir MP3. This blood flows through the second branch, i.e. along direction Dir3b into cannula CA3 and is delivered out of distal opening DO3 into aorta AO. Within the next pumping cycle this is repeated. Alternatively, reservoir MP3 may have only one port for blood transfer and oxygenator OXY3 may be an oxygenator for bidirectional flow, i.e. no bifurcation element is needed.
[0272] Alternatively, the inlet opening may be arranged within vena cava VC, i.e. the distance between the distal end of cannula CA3 and intermediate opening IO3 has to be increased, for instance by a value within the range of 2.5 cm to 7.5 cm, preferably by 5 cm. The length of cannula CA3 may be the same independent of the location of intermediate opening IO3 in vena cava VC or in right atrium RA.
[0273]
[0277] Proximal portion PP4 of cannula CA4 may be connected to a pump or to a variable volume reservoir MP4. An extracorporeal oxygenator OXY4 may be inserted between cannula CA4 and the pump or variable volume reservoir MP4 for lung L support.
[0278] Oxygenator OXY4 may be a commercially available oxygenator. A blood filter unit may be used in addition to the oxygenator OXY4. Medicaments/drugs or other treatment substances may be given or administered by an optional drug delivery unit that may be included into the fluidic circuitry that is shown in
[0279] An assembly A4 may comprise cannula CA4 and variable volume reservoir MP4 or a pump. Variable volume reservoir MP4 may be arranged as near as possible to body 100 of a patient. Variable volume reservoir MP4 may comprise: [0280] a rigid housing or casing, [0281] a flexible membrane M within the housing, [0282] one port for blood transport or two ports for blood inflow and blood outflow, and [0283] at least one port Po4, that is connected with a fluid reservoir, for instance with a gas reservoir, especially helium or air reservoir.
[0284] If reservoir MP4 has only one port for blood transport, oxygenator OXY4 may be coupled fluidically between this port and cannula CA4. Alternatively, reservoir MP4 may have two ports for blood transport as shown in
[0285] Port Po4 may be connected to a piston arrangement or to another arrangement that is able to pump gas or another fluid, for instance a liquid, in and out of the housing of reservoir MP4. The piston arrangement or the other arrangement may be controlled depending on the heartbeat of the patient, e.g. based on electrocardiography (ECG) signals or data or other sensor signals or data. Preferably the diastole of left ventricle LV may be used to drain blood into Aorta AO. However, other timing schemes are possible as well.
[0286] Intermediate portion IP4 of cannula CA3 may comprise at least one intermediate opening IO4. Intermediate portion IP4 may be configured such that two different flows are generated in intermediate portion IP4 and in distal portion DP4 depending on the direction of the blood flow in proximal portion PP4. A simple solution for this flow selectivity is the usage of a two-way valve or of another valve configuration. Alternatively or additionally, an appropriate fluidically design of cannula CA4 may be used.
[0287] The distal portion DP4 may comprise at least one or exactly one distal opening DO4, for instance in combination with an expandable arrangement, e.g. a cage arrangement.
[0288] Optional expandable arrangements may be used around intermediate opening IO4 and/or distal opening DO4. The expandable arrangements may fulfill a fixation function and/or other functions as mentioned above.
[0289] If the blood flow in proximal part PP4 is directed proximally, blood is sucked or drained into (see arrow I) intermediate opening IO4 but not or only to a less degree through distal opening DO4. If the blood flow in the proximal part PP4 is directed distally, blood is delivered out of distal opening DO4, see arrow O, but not or only to a less degree out of intermediate opening IO4.
[0290] The total length of cannula CA4 may be as mentioned above for variant 4. The distance between distal end of cannula CA4 and intermediate opening IO4 may be as mentioned above for variant 4.
[0291] Cannula CA4 may be inserted endovascularly and jugular through vena cava VC, preferably through superior vena cava SVC, to right atrium RA and punctured transcaval directly from right atrium RA into aorta AO and then inserted up to the ascending aorta aAO, AO. Blood may be drained through intermediate opening IO4 from right atrium RA if membrane M increases the volume of reservoir MP4. This blood flows in the first branch along direction Dir4a into reservoir MP4. Blood is delivered out of reservoir MP4 if membrane M decreases the volume of reservoir MP4. This blood flows through the second branch, i.e. along direction Dir4b into cannula CA4 and is delivered out of distal opening DO4 into aorta AO. Within the next pumping cycle this is repeated. Alternatively, reservoir MP4 may have only one port for blood transfer and oxygenator OXY4 may be an oxygenator for bidirectional flow, i.e. no bifurcation element is needed.
[0292] Alternatively, the inlet opening may be arranged within vena cava VC, i.e. the distance between the distal end of cannula CA4 and intermediate opening IO4 has to be increased, for instance by a value within the range of 2.5 cm to 7.5 cm, preferably by 5 cm. The length of cannula CA4 may be the same independent of the location of intermediate opening IO4 in vena cava VC or in right atrium RA.
[0293] Variant 4b: A cannula CA4a may be similar to cannula CA4. However, the difference is that cannula CA4a is inserted endovascular, preferably jugular, up to vena cava VC and then punctured directly transcaval from vena cava VC directly to aorta AO, for instance to ascending aorta aAO. An intermediate opening IO4a may be located within vena cava VC and may be used for blood drainage or blood removal from vena cava VC. Blood delivery remains into aorta AO, preferably into ascending aorta AO. At least one oxygenator may be used, for instance coupled into a one directional flow or a bi-directional flow of the fluid circuitry. The length of cannula CA4a may be the same as the length of cannula CA4. The distance between the distal end and the intermediate opening IO4a may be increased for cannula CA4a if compared to the same distance at cannula CA4 in the range of 2.5 cm to 7.5 cm, preferably by 5 cm.
[0294] Variant 10: A cannula CA10 may be coupled to variable volume reservoir MP4 in the same way as cannula CA4. Alternatively, the oxygenator may be coupled to a reservoir MP4 having only one port for blood transport. In another embodiment for cannula CA10 no oxygenator may be used. However in both cases (i.e. with or without oxygenator), cannula CA10 may be inserted endovascular, preferably jugular, up to vena cava VC, then to right atrium RA and then punctured directly, i.e. transcaval, from right atrium RA directly into pulmonary artery PA, especially into main pulmonary artery PA. The length of cannula CA10 may be the length that is mentioned above in item a10). The distance between the distal tip and the intermediate opening IO10 of cannula 10 may be the distance that is mentioned above in item a10). Blood drainage may be made from vena cava VC or from right atrium RA.
[0295] Variant 10b: A cannula CA10a may be similar to cannula CA10. However, the difference is that cannula CA10a is inserted endovascular, preferably jugular, up to vena cava VC and then punctured directly from vena cava VC transcaval to pulmonary artery PA. An intermediate opening IO10a may be located within vena cava VC and may be used for blood drainage from vena cava VC. Blood delivery may remain into aorta AO, preferably into ascending aorta AO. At least one oxygenator may be used, for instance coupled into a one directional flow or a bi-directional flow of the fluid circuitry. The length of cannula CA10a may be the same as the length of cannula CAb0. The distance between the distal end and the intermediate opening may be increased for cannula CA10a if compared to the same distance at cannula CA10 in the range of 2.5 cm to 7.5 cm, preferably by 5 cm.
[0296]
[0300] Proximal portion PP5 may be connected to a pump or to a variable volume reservoir. An extracorporeal oxygenator may be inserted between cannula CA5 and the pump or the variable volume reservoir if lung support is needed. However, left heart support may be performed without oxygenation if no lung support is needed, i.e. the lung of the patient is able to deliver enough oxygen for body 100.
[0301] Intermediate portion IP5 may comprise at least one intermediate opening IO5. Intermediate portion IP5 may be configured such that depending on the direction of the blood flow in the proximal portion PP5 two different flows are generated in the intermediate portion IP5 and in the distal portion DP5. A simple solution for this flow selectivity is the usage of a two-way valve or of another valve configuration. Alternatively or additionally, an appropriate fluidically design of cannula CA5 may be used.
[0302] Distal portion DP5 may comprise at least one or exactly one distal opening DO5.
[0303] Optional expandable arrangements may be used around intermediate opening IO5 and/or distal opening DO5. The expandable arrangements may fulfill a fixation function and/or other functions as mentioned above.
[0304] If the blood flow in proximal part PP5 is directed proximally, blood is sucked or drained into (see arrow I) intermediate opening IO5 but not or only to a less degree through distal opening DO5. If the blood flow in proximal part PP5 is directed distally, blood is delivered out of distal opening DO5, see arrow O, but not or only to a less degree out of intermediate opening IO5.
[0305] The total length of cannula CA5 may be as mentioned above for variant 5. The distance between distal end of cannula CA5 and intermediate opening IO5 may be as mentioned above for variant 5.
[0306] Cannula CA5 may be inserted endovascularly and jugular through vena cava VC, right atrium RA, right ventricle RV, ventricle septum VS, left ventricle LV at least up to ascending aorta aAO, AO with blood drainage through intermediate opening IO5 from left ventricle LV and with blood delivery out of distal opening DO5 into the aorta AO.
[0307]
[0311] Proximal portion PP6 of cannula CA6 may be connected to a pump or to a variable volume reservoir MP6. An extracorporeal oxygenator OXY6 may be inserted between cannula CA6 and the pump or the variable volume reservoir if lung L support is needed. However, left heart H support may be performed without oxygenation if no lung L support is needed, i.e. lung L of the patient is able to deliver enough oxygen for body 100.
[0312] Oxygenator OXY6 may be a commercially available oxygenator. A blood filter unit may be used in addition to the oxygenator OXY6. Medicaments/drugs or other treatment substances may be given or administered by an optional drug delivery unit that may be included into the fluidic circuitry that is shown in
[0313] An assembly A6 may comprise cannula CA6 and variable volume reservoir MP6. Variable volume reservoir MP6 may be arranged as near as possible to body 100 of a patient. Variable volume reservoir MP6 may comprise: [0314] a rigid housing or casing, [0315] a flexible membrane M within the housing, [0316] one port for blood transport or two ports for blood inflow and blood outflow, and [0317] at least one port Po6, that is connected with a fluid reservoir, for instance with a gas reservoir, especially helium or air reservoir.
[0318] If reservoir MP6 has only one port for blood transport, oxygenator OXY6 may be coupled fluidically between this port and cannula CA6. Alternatively, reservoir MP6 may have two ports for blood transport as shown in
[0319] Port Po6 may be connected to a piston arrangement or to another arrangement that is able to pump gas or another fluid, for instance a liquid, in and out of the housing of reservoir MP6. The piston arrangement or the other arrangement may be controlled depending on the heartbeat of the patient, e.g. based on electrocardiography (ECG) signals or data or other sensor signals or data. Preferably the diastole of left ventricle LV may be used to drain blood into aorta AO. However, other timing schemes are possible as well.
[0320] Intermediate portion IP6 of cannula CA6 may comprise at least one intermediate opening IO6. The intermediate portion IP6 may be configured such that depending on the direction of the blood flow in the proximal portion PP6 two different flows are generated in intermediate portion IP6 and in distal portion DP6. A simple solution for this flow selectivity is the usage of a two-way valve or of another valve configuration. Alternatively or additionally, an appropriate fluidically design of cannula CA6 may be used.
[0321] Distal portion DP6 may comprise at least one or exactly one distal opening DO6, for instance in combination with an expandable arrangement, e.g. a cage arrangement.
[0322] Optional expandable arrangements may be used around intermediate opening IO6 and/or distal opening DO6. The expandable arrangements may fulfill a fixation function and/or other functions as mentioned above.
[0323] If the blood flow in the proximal part PP6 is directed proximally, blood is sucked or drained into (see arrow I) intermediate opening IO6 but not or only to a less degree through distal opening DO6. If the blood flow in the proximal part PP6 is directed distally, blood is delivered out of distal opening DO6, see arrow O, but not or only to a less degree out of intermediate opening IO6.
[0324] The total length of cannula CA6 may be as mentioned above for variant 6. The distance between distal end of cannula CA6 and intermediate opening IO6 may be as mentioned above for variant 6.
[0325] Cannula CA6 may be inserted endovascularly and jugular through vena cava VC, preferably through superior vena cava SVC, right atrium RA, right ventricle RV, ventricle septum VS, left ventricle LV at least up to the ascending aorta aAO, AO. Blood may be drained into intermediate opening IO6 from right atrium RA if membrane M increases the volume of reservoir MP6. This blood flows in the first branch along direction Dir6a into reservoir MP6. Blood is delivered out of reservoir MP6 if membrane M decreases the volume of reservoir MP6. This blood flows through the second branch, i.e. along direction Dir6b into cannula CA6 and is delivered out of distal opening DO6 into the aorta AO. Within the next pumping cycle this is repeated.
[0326] Alternatively, the inlet opening may be arranged within vena cava VC, i.e. the distance between the distal end of cannula CA6 and intermediate opening IO6 has to be increased appropriately. The length of cannula CA6 may be the same independent of the location of intermediate opening IO6 in vena cava VC or in right atrium RA.
[0327] Furthermore, alternatively, the inlet opening may be arranged within right ventricle RV, i.e. the distance between the distal end of cannula CA6 and intermediate opening IO6 has to be decreased appropriately. The length of cannula CA6 may be the same independent of the location of intermediate opening IO6 in right ventricle RV or in right atrium RA.
[0328] Further variants with delivery of blood into pulmonary artery PA, for instance right heart H support and/or lung L support:
[0329] Variant 7: A cannula CA7 that has an intermediate portion that is similar to intermediate portion IP6 may be inserted endovascularly and jugular through vena cava VC, preferably superior vena cava SVC, right atrium RA, right ventricle RV at least up to pulmonary artery PA. Blood may be drained through intermediate opening IO7 from right atrium RA if the membrane M increases the volume of reservoir MP6. This blood flows in the first branch along direction Dir6a into reservoir MP6. Blood may be delivered out of reservoir MP6 if the membrane M decreases the volume of reservoir MP6. This blood flows through the second branch, i.e. along direction Dir6b into cannula CA7 and is delivered out through distal opening DO7 into pulmonary artery PA. Within the next pumping cycle this is repeated. Alternatively, reservoir MP6 may have only one port for blood transfer and oxygenator OXY6 may be an oxygenator for bidirectional flow, i.e. no bifurcation element is needed.
[0330] Alternatively, no oxygenator OXY6 may be used, for instance in no lung L support is needed for variant 7.
[0331] Variant 8: Same as variant 7 but drainage from right ventricle RV. The total length of a cannula CA8 may be the same as the total length of cannula CA7 but the distance between the distal tip and the intermediate opening may be reduced appropriately as mentioned in the first part of the description and in the claims.
[0332] Variant 9: Same as variant 7 but drainage from vena cava VC. The total length of a cannula CA9 may be the same as the total length of cannula CA7 but the distance between the distal tip and the intermediate opening may be increased appropriately as mentioned in the first part of the description and in the claims.
[0333] Variant 11: A cannula CA11 that has a modified intermediate part may be used. The cannula CA11 of variant 11 may have a modified intermediate portion IP11. The intermediate portion IP1I of cannula CA11 may comprise at least one intermediate opening IO11. The intermediate portion IP11 may be configured such that depending on the direction of the blood flow in a proximal portion PP11 of cannula CA11 two different flows are generated in the intermediate portion IP11 and in a distal portion DP11 of cannula CA11. A simple solution for this flow selectivity is the usage of a two-way valve or of another valve configuration. Alternatively or additionally, an appropriate fluidically design of cannula CA11 may be used.
[0334] If the blood flow in the proximal part PP11 is directed distally, blood is delivered out of intermediate opening IO11, but not or only to a less degree through distal opening DI11. If the blood flow in the proximal part PP11 is directed proximally, blood is sucked or drained into distal opening DI3 but not or only to a less degree through intermediate opening IO11.
[0335] It may be possible to inverse the operating directions of cannula CA11 compared to the operating directions of cannula CA1 to CA10, for instance by changing the assembly direction of a valve or of several valves that are used within cannulas CA1 to CA10 mentioned above.
[0336] Cannula CA11 may be inserted endovascularly, for instance through a subclavian vein into the aorta and further into left ventricle LV. Blood may be drained out of left ventricle LV and delivered into aorta AO, preferably into ascending aorta aAO. Cannula CA11 may have a distal expandable arrangement and/or an expandable arrangement at the intermediate opening.
[0337] An oxygenator may be used together with the arrangement of cannula CA11. Alternatively no oxygenator may be used. Other medical applications of cannula CA11 with or without the usage of an oxygenator are possible as well.
[0338]
[0339] Membrane pump MP7 may be a one port membrane pump which may comprise or have only one port for liquid transport into the membrane pump MP7 and our of membrane pump MP7.
[0340] Bidirectional cannula CA107 may be visible in an X-ray device or within another medical image generating device. Using the image generating device, the intermediated opening may be aligned such that it is directed to the center of the right atrium RA thus resulting in flow out of the intermediate opening IO107 which is directed directly to the tricuspid valve TV. A complete antegrad outflow is generated therewith, i.e. a blood flow which is directed in the natural flow directions of the blood. Opposite pulsation is avoided which results in less unnatural turbulences. The same may be valid for other bidirectional cannulas CA108, CA109a and CA110a mentioned below.
[0341] There may be the following dimensions of cannula CA107:
TABLE-US-00001 Body height of 110 cm 140 cm 160 cm 180 cm 200 cm patient Distance 5 cm to 10 cm 10 cm to 15 cm 15 cm to 20 cm 20 cm to 25 cm 25 cm to 30 cm between IO107 and DP107 Outer diameter, 19 Fr 21 Fr 23 Fr 25 Fr 27 Fr or 29 Fr for instance at (French) PP107 and/or at DP107
[0342]
[0350] There may be the following dimensions of cannula CA108:
TABLE-US-00002 Body height of 110 cm 140 cm 160 cm 180 cm 200 cm patient Distance 5 cm to 10 cm 10 cm to 15 cm 15 cm to 20 cm 20 cm to 25 cm 25 cm to 30 cm between IO108 and DP108 Outer diameter, 19 Fr 21 Fr 23 Fr 25 Fr 27 Fr or 29 Fr for instance at (French) PP108 and/or at DP108
[0351] Support system 800 may use two membrane pumps MP8a or MP8b in parallel (dual membrane pump) or a single membrane pump. Membrane pumps MP8a and MP8b may be coupled to the same port of an IABP console IABP8. IABP console IABP8 may be controlled by electrical signals of heart H. Both membrane pumps MP8a or MP8b may be connected to a proximal portion PP108 of bidirectional cannula CA108 via a branch B8 and a connection C8. Branch B8 may be a Y-connector, a T-connector or another three-port element.
[0352] The function of arrangement 800 is similar to the function of arrangement 700, e.g. renal support is possible.
[0353]
[0354] Support system 900 may comprise a cannula system CS. Cannula system CS may comprise or may consist of the bidirectional cannula CA109a and an outer cannula CA109b. Bidirectional cannula CA109a may comprise: [0355] a proximal portion PP109a, [0356] an intermediate portion IP109a, [0357] an intermediate opening IO109a, [0358] a distal portion DP109a, and [0359] a distal opening DO109a.
[0360] Outer cannula CA109b may comprise: [0361] a proximal portion PP109b, [0362] a distal portion DP109b that comprises at least one distal opening DO109b, [0363] a lumen portion LP that extends from the proximal portion PP109b to the at least one distal opening DO109b, and [0364] at least one intermediate portion IP109b that is arranged between the proximal portion PP109b and the distal portion DP109b.
[0365] The intermediate portion IP109b of the outer cannula CA109b may comprise at least one lateral intermediate opening IO109b which may be configured to allow passage of the distal portion DP109a of the bidirectional cannula CA109a.
[0366] Before inserting the bidirectional cannula CA109a into the body of the patient, outer cannula CA109b may be inserted through the vessel of the blood circuit. Distal portion DP109b of outer cannula CA109b may be inserted endovascularly, preferably jugularly, through superior vena cava SVC, right atrium RA and right ventricle RV at least to the pulmonary artery PA,
[0367] Thereafter, the bidirectional cannula CA109a may be inserted into a first part FP-LP of the lumen portion of the outer cannula CA109b until the distal portion DP109a of the bidirectional cannula CA109a extends through the intermediate opening IO109b of the outer cannula CA109b and the intermediate opening IO109a of the bidirectional cannula CA109a is arranged within and/or aligned with the intermediate portion IP109b of the bidirectional cannula CA109a thereby being in fluidic connection with the distal portion DP109b of the outer cannula CA109b via a second part SP-LP of the lumen portion of the outer cannula CA109b. The distal portion DP109a of the bidirectional cannula CA109a is inserted into right atrium RA optionally further into inferior vena cava IVC.
[0368] Thereby, a first part FP-LP of the lumen portion of the outer cannula CA109b is formed between an inner surface of outer cannula CA109b and an outer surface of bidirectional cannula CA109a is formed. Furthermore, a second part SP-LP of the lumen portion of the outer cannula CA109b is formed between the intermediate opening IO109a of the bidirectional cannula CA109a and the distal portion DP109b of the outer cannula CA109b. The first part FP-LP of the lumen portion of the outer cannula CA109b may form a “dead” lumen portion.
[0369] Blood is drained into the at least one distal opening DO109a of the bidirectional cannula CA109a, see arrow 109a. Blood is transported in an aspiration phase into membrane pumps MP9a, MP9b; MP9c. In an expulsion phase blood is transported in the opposite direction. Due to the valves within bidirectional cannula CA109a or due to a specific fluidic design, blood is delivered out of the at least one intermediate opening IO109a of bidirectional cannula CA109a in the expulsion phase, see arrow A109b. Blood is delivered further through the at least one distal opening DO109b of the outer cannula CA109b, see arrow A109c. Usage of an oxygenator is optional in pVRAD® system 900.
[0370] Although outer cannula CA109b is illustrated with different diameters, especially in the intermediate portion IP109b it is of course also possible to have a constant diameter along the longitudinal axis of outer cannula CA109b.
[0371] Furthermore, outer cannula CA109b may have a kink K in the intermediate portion. In a state without outer forces (base state) the kink K may include an angle in the range of 80 degrees to 130 degrees, preferably 110 degrees. The kink K may facilitate the insertion of the distal portion DP109a of bidirectional cannula CA109a through intermediate opening IO109b of outer cannula CA109b. However, it is also possible to use an outer cannula without a kink K. Intermediate opening IO109b of outer cannula CA109b may be arranged at kink K, preferably in a distance from the kink which is less than 3 cm or less than 2 cm or less than 1 cm.
[0372] The bidirectional cannula CA109a may be essentially straight or straight if no external forces are applied. This may be true also for bidirectional cannulas CA107 and CA108 which are mentioned above.
[0373] With regard to valves V9a, V9b and V9c see description at the end of the description of
[0374] There may be the following dimensions of cannula CA109a:
TABLE-US-00003 Body height of 110 cm 140 cm 160 cm 180 cm 200 cm patient Distance 1 cm to 5 cm or 1 cm to 5 cm or 1 cm to 5 cm or 1 cm to 5 cm or 1 cm to 5 cm or between IO109a 1 cm to 3 cm 1 cm to 3 cm 1 cm to 3 cm 1 cm to 3 cm 1 cm to 3 cm and DP109a Outer diameter, 19 Fr 21 Fr 23 Fr 25 Fr 27 Fr or 29 Fr for instance at PP109a and/or at DP109b
[0375] The distal portion DP109b of the outer cannula CA109b may have the same outer diameter as the distal portion DP109a of the bidirectional cannula CA109a. Alternatively, the distal portion DP109b of the outer cannula CA109b may have a greater outer diameter than the distal portion DP109a of the bidirectional cannula CA1009a, for instance greater by at least 2 French but not greater than 8 French compared to the outer diameter of the distal portion DP109a of the bidirectional cannula CA109a. Alternatively, greater by at least 3 French but not greater than 8 French.
[0376] There may be the following dimensions of outer cannula CA109b:
TABLE-US-00004 Body height of 110 cm 140 cm 160 cm 180 cm 200 cm patient Length of 40 cm 50 cm 60 cm 70 cm 80 cm cannula (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm CA109b and/or minus and/or minus and/or minus and/or minus and/or minus max. 5 cm) max. 5 cm) max. 5 cm) max. 5 cm) max. 5 cm) Distance 8 cm 13 cm 18 cm 23 cm 28 cm IO109b to 6 cm to 10 cm 11 cm to 15 cm 16 cm to 20 cm 21 cm to 25 cm 24 cm to 30 cm DP109b
[0377] A conical portion ConP of outer cannula CA1009b may have a length of less than 10 cm for all cases, e.g. all body height. The conical portion ConP may have a reduction in diameter of at least 4 French of at least 5 French but preferably of not more than 8 French or of not more than 10 French. The conical portion ConP may be located distally adjacent to kink K and/or distally adjacent to intermediate portion JP109b.
[0378] The function of arrangement 900 is as follows. In an aspiration phase of the membrane pumps MP9a, MP9b or of the membrane pump MP9c blood is sucked from right atrium RA and/or inferior vena cava IVC into or drained into distal opening DO109a of bidirectional cannula CA109a into the variable volume reservoir of the membrane pump MP9a, MP9b or MP9c, see arrow A119a. In an expulsion phase of the membrane pumps MP9a, MP9b or of the membrane pump MP9c blood is expulsed or delivered out of intermediated opening IO109a of bidirectional cannula CA109a through a second part SP-LP of the outer cannula CA109b and out of distal opening DO109b of outer cannula CA109b into pulmonary artery PA. Thereafter, the cycle of aspiration phase and expulsion phase is repeated, for instance synchronous to the beats of heart H.
[0379]
[0385] An outer cannula CA110b may comprise: [0386] a proximal portion PP110b, [0387] a distal portion DP11Gb1, DP110b2 that comprises at least one distal opening DO110b1 or DP110b2, [0388] a lumen portion LP that extends from the proximal portion PP110b to the at least one distal opening DO110b1 or DPb102, and [0389] at least one intermediate portion IP110b that is arranged between the proximal portion PP110b and the distal portion DP110b1 or DP110b2.
[0390] The intermediate portion IP110b of the outer cannula CA11 Ob may comprise at least one lateral intermediate opening IO110b or exactly one lateral intermediate opening IO110b which is configured to allow passage of the distal portion DP110a of the bidirectional cannula CA110a.
[0391] Again, the outer cannula CA110b may be inserted before bidirectional cannula CA110a is inserted into the body of the patient. In a first alternative (variant 1), the distal portion DP110b1 of the outer cannula CA110b is inserted endovascularly, preferably jugularly, through superior vena cava SVC, right atrium RA and atrial septum AS up to the left atrium LA of the heart H.
[0392] In a second alternative (variant 2), the distal portion DP110b2 of the outer cannula CA110b may be inserted endovascularly, preferably jugularly, through superior vena cava SVC, right atrium RA and atrial septum AS up to the left atrium LA of the heart H. In a further alternative which is not illustrated the distal portion DP110b2 of the outer cannula CA110b is inserted further, for instance up to the ascending aorta AO.
[0393] After insertion of the outer cannula CA110b, e.g. after the outer cannula is in place, the distal portion DP110a of the bidirectional cannula CA110a is inserted through the proximal portion PP110b of the outer cannula CA110b, through the intermediate portion IP110b of the outer cannula CA110b, through the intermediate opening IO110b of the outer cannula CA110b, into the right atrium RA, through the right ventricle RV and at least to or up to the pulmonary artery PA.
[0394] Thereby, a first part FP-LP of the lumen portion of the outer cannula CA110b is formed between an inner surface of outer cannula CA110b and an outer surface of bidirectional cannula CA110a is formed. Furthermore, a second part SP-LP of the lumen portion of the outer cannula CA110b is formed between the intermediate opening IO110a of the bidirectional cannula CA110a and the distal portion DP110b of the outer cannula CA110b. The first part FP-LP of the lumen portion of the outer cannula CA110b may form a “dead” lumen portion.
[0395] At least one membrane pump MP10 may comprise for instance two blood ports which may be connected with the proximal end of the bidirectional cannula CA110a as is explained below in more detail. Membrane pump MP10 may be operated on an IABP console IABP10.
[0396] A connecting portion CP10 may be used, for instance a Y-connector. The connecting portion CP10 may be connected to: [0397] a separated portion SP10a, [0398] a separated portion SP10b, and [0399] a separated portion SP10c.
[0400] Separated portion SP10a may connect the connecting portion with an inlet port of membrane pump MP11. A one-way valve V10a may be arranged within a separated portion SP10a. Alternatively and/or additionally a one-way valve may be arranged within separated portion SP10b.
[0401] Separated portion SP10b may connect an outlet port of device D10 with connecting portion CP10. Separated portion SP10c may be connected to proximal portion PP110a of bidirectional cannula.
[0402] A further separated portion SP10d may connect an outlet port of membrane pump MP10 with an inlet port of device D10.
[0403] There is the following function of arrangement 1000. Blood may be drained into the at least one distal opening DO110 of the bidirectional cannula CA110a in an aspiration phase from pulmonary artery PA, see arrow A110a. In an expulsion phase of the membrane pump operation blood is delivered out of the at least one intermediate opening IO110a of the bidirectional cannula CA110a and further through the at least one distal opening DO110b1 of the outer cannula CA11 Ob into left atrium LA in the first alternative (variant 1), see arrows A110d and A110e. In the second alternative (variant 2), blood is delivered out of the at least one intermediate opening IO110a of the bidirectional cannula CA110a and further through the at least one distal opening DO100b2 of the outer cannula CA11 Ob into left ventricle LV, see arrows Al10d and A110f.
[0404] Due to one-way valve V10a a fluid circulation is realized. Blood which is sucked into separated portion SP10c flows only through portion SP10a but not through portion SP10b, see arrow A110b. Device D10 may have an inherent valve function. Alternatively or additionally a further one-way valve may be used within separated portion SP10d or SP10c. Moreover, the one-way valves may also be integrated within the ports of membrane pump MP10. Blood which is expulsed out of membrane pump MP10 flows only through separated portions SP10d, device D10 and separated portion SP10b, see arrow A110c. One-way valve V10a blocks the flow through separated portion SP10a. Expulsed blood flows then through separated portion SP10c into bidirectional cannula CA110a.
[0405] The drained blood may be enriched in all alternatives with oxygen and/or it may be depleted from carbon dioxide outside of the body of a patient before it is delivered out of the intermediate opening IO110a of the bidirectional cannula CA110a. An ECCO.sub.2R (extracorporeal carbon dioxide removal) device D10 may be used which may have lower pressures and/or throughput rates (volume per minute) compared to the usage of an oxygenator which may be used instead of the ECCO.sub.2R device, especially within an ECMO (extracorporeal membrane oxygenation). However, both blood treatment methods are optionally.
[0406] With regard to the pumps see variants 3, 4, 6, i.e.
[0407] Furthermore, valves V9a to V10c or other sealing elements may be used, for instance multi-flap valves or another self-sealing member (for instance a simple sealing ring), i.e. for instance two flexible membranes. Other types of hemostasis valves may also be used.
[0408] Valve V9a, V10a may prevent that blood flows out of the proximal portion PP109b, PP110b of the outer cannula CA109b, CA110b, especially if the bidirectional cannula CA109a, Ca110a is not yet in the inserted state within outer cannula CA109b, CA110b. A multi-flap valve may be used for valve V9a, V10a.
[0409] Valve V9b, V10b may prevent that blood flows into the space or “dead” lumen between intermediate portion IP109b, IP110b and thus into a possible space between both cannulas CA109a, CA109b or CA110a, CA110b. This may result in preventing clotting of the blood in regions of the cannula system where the blood flow may be not high enough. A multi-flap valve may be used for valve V9b, V10b. Alternatively, a sealing ring or other sealing member may be used for valve V9b, V10b.
[0410] Valve V9c, V10c may be used to prevent that blood which is delivered out of intermediate opening IO109a, IO110a of bidirectional cannula CA109a, CA10a flows out of intermediate opening IO109b, IO110b of outer cannula CA109a, CA110b and thus in regions in which it should not be flow, i.e. the complete delivery flow may reach the distal opening DO109b, DO110b1 or DO110b2. If valve V9b, V10b is used valve V9c, V10c may be a simple sealing ring. However, other types of valves may also be used for valves V9c, V10c. A multi-flap valve may be used for valve V9c, V10c.
[0411] Valves V9b, V9c, V10b and V10c make sure that blood that flows out of intermediate opening IO109a, IO110a flows within outer cannula CA109b, CA110b to the distal opening DO109b, DO110b1 or DO110b2.
[0412] Although outer cannula CA110b is illustrated with different diameters, especially in the intermediate portion IP110b it is of course also possible to have a constant diameter along the longitudinal axis of outer cannula CA10b.
[0413] Furthermore, outer cannula CA110b may have a kink K in the intermediate portion. In a state without outer forces (base state) the kink K may include an angle in the range of 80 degrees to 130 degrees, preferably 110 degrees. The kink K may facilitate the insertion of the distal portion DP110a of bidirectional cannula CA110a through intermediate opening IO110b of outer cannula CA110b. However, it is also possible to use an outer cannula without a kink K. Intermediate opening IO110b of outer cannula CA110b may be arranged at kink K, preferably in a distance from the kink which is less than 3 cm or less than 2 cm or less than 1 cm.
[0414] There may be the following dimensions of cannula CA110a:
TABLE-US-00005 Body height of 110 cm 140 cm 160 cm 180 cm 200 cm patient Distance 8 cm 13 cm 18 cm 23 cm 28 cm between IO110a 6 cm to 10 cm 11 cm to 15 cm 16 cm to 20 cm 21 cm to 25 cm 24 cm to 30 cm and DP110a or 26 cm to 30 cm Outer diameter, 19 Fr 21 Fr 23 Fr 25 Fr 27 Fr or 29 Fr for instance at PP110a and/or at DP110b
[0415] The distal portion DP110b of the outer cannula CA10b may have the same outer diameter as the distal portion DP110a of the bidirectional cannula CA110a. Alternatively, the distal portion DP110b of the outer cannula CA110b may have a greater outer diameter than the distal portion DP110a of the bidirectional cannula CA110a, for instance greater by at least 2 French but not greater than 8 French compared to the outer diameter of the distal portion DP110a of the bidirectional cannula CA110a. Alternatively, greater by at least 3 French but not greater than 8 French.
[0416] There may be the following dimensions of outer cannula CA110b in variant 1 (distal portion DP110b1 in LA):
TABLE-US-00006 Body height of 110 cm 140 cm 160 cm 180 cm 200 cm patient Distance 3 cm to 5 cm 5 cm to 7 cm 7 cm to 10 cm 10 cm to 13 cm 13 cm to 15 cm between IO110b and DP110b1 Length of 30 cm 40 cm 50 cm 60 cm 70 cm cannula (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm CA1010b and/or minus and/or minus and/or minus and/or minus and/or minus max. 5 cm) max. 5 cm) max. 5 cm) max. 5 cm) max. 5 cm)
[0417] There may be the following dimensions of outer cannula CA110b in variant 2 (distal portion DP110b2 in LV and/or in aorta AO):
TABLE-US-00007 Body height of 110 cm 140 cm 160 cm 180 cm 200 cm patient Distance 23 cm to 25 cm 25 cm to 27 cm 27 cm to 30 cm 30 cm to 33 cm 33 cm to 35 cm between IO110b and DP110b2 Length of 50 cm 60 cm 70 cm 80 cm 90 cm cannula (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm (plus max. 5 cm CA1010b and/or minus and/or minus and/or minus and/or minus and/or minus max. 5 cm) max. 5 cm) max. 5 cm) max. 5 cm) max. 5 cm)
[0418] The conical portion ConP may have a length of less than 10 cm for all cases, e.g. all body height. The conical portion ConP may have a reduction in diameter of at least 4 French of at least 5 French but preferably of not more than 8 French or of not more than 10 French. The conical portion ConP may be located distally adjacent to kink K and/or distally adjacent to intermediate portion IP110b.
[0419] Within the cannula system CS which comprises an inner cannula and an outer cannula there may also be the opposite flow directions compared to the flow directions mentioned above.
[0420] Furthermore, the inner cannula of the cannula system CS has not necessarily to be a bidirectional cannula, e.g. a unidirectional cannula may also be used, for instance a single lumen cannula without internal valve and without an internal valve function.
[0421] Other medical applications of the cannula system are possible as well.
[0422] In other words, the following is proposed: [0423] a bi-directional flow catheter comprising for instance a two way valve. Access may be made via right jugular vein, for instance via right internal jugular vein rIJV, or left jugular vein, for instance left internal jugular vein IIJV, further to right atrium RA, then transseptal (atrial septum) into left atrium LA, through mitral valve MV, left ventricle LV at least to ascending aorta aAO or exactly to ascending aorta aAO.
[0424] Alternatively, a way or path through ventricle septum VS may be chosen, [0425] right heart H assist, optionally combined with lung assist; the cannula is inserted preferably through vena cava, right atrium, right ventricle to pulmonary artery, [0426] transcaval access is also possible for both possibilities, i.e. delivery into aorta AO or into pulmonary artery PA.
[0427] Variant 1, see
[0428] Variant 2, see
[0429] Variant 3, see
[0430] Variant 4, see
[0431] Variant 5, see
[0432] Variant 6, see
[0433] The membrane pump that may be used in variants 1, 2 and 5 or in the other variants 3, 4 and 6 etc. may have only one port that is fluidly connected with the cannula, wherein the port does not comprise a valve. The cannula may include a two-way directional valve.
[0434] The membrane pump that may be used in variants 3, 4 and 6 or in the other variants 1, 2 and 5 etc. may have at least one inlet port and an outlet port in which a valve is mounted, respectively, for instance a one-way valve. Conduits that are connected to these ports may be united or joint between the pump and the cannula that is preferably a single lumen cannula. The cannula may include a two-way valve or alternatively several one way valves or another technical solution that enables a bidirectional flow in the proximal part of the cannula and direction dependent flows through the distal tip and through an intermediate opening of the catheter/cannula.
[0435] A pump having only one port may be used. Alternatively, a pump having an inlet port and an outlet port may be which comprise preferably one-way valves respectively. The two-way valve or the other fluidically mechanical solution within the cannula may still be used in order to control the direction of fluid flows through the distal part and through the at least one opening within the intermediate portion of the cannula.
[0436] The catheter/cannula diameter may be more than 23 F (French) and up to 36 F or more. No remaining room for blood flow in a vessel may be necessary anymore because the cannula may deliver sufficient flow rates alone, i.e. without the help of the blood circuit of body 100. For all embodiments, the outer diameter of the cannula/catheter may be equal to or more than 25 F up to 36 F, most preferred in the range of 29 F to 33 F. This may be more than 20 percent more compared to other solutions.
[0437] A dual chamber membrane pump with 40 ml (milliliter) or more and up to 160 ml pumping volume may be used. For all embodiments, a membrane pump, for instance MP3, MP4 and MP6 to MP10, with 60 ml or more up to 160 ml pumping volume may be used, most preferred in the range between 80 ml to 120 ml. This may be more than twice of the pumping volume that may be used for other solution.
[0438] At least one pump for driving a fluid flow may be used, for instance a membrane pump (pulsatile flow), especially comprising a flat membrane or a ring membrane. The pump volume of the pump may be preferably greater than the volume in the cannula between the distal end of the cannula and the inlet of the pump, especially a membrane pump, i.e. there may be no or only a small dead volume. This may result in no or only less clotting of blood within the cannula and/or the pump or variable volume reservoir.
[0439] The proposed solutions may be used for instance as: [0440] as a short term solution for a bridge to decision, for instance up to 30 days or more, alternatively for instance up to 60 days depending on authorization, [0441] a bridge to bridge (left ventricular assist device LVAD), for instance up to 30 days or more, alternatively for instance up to 60 days depending on authorization, [0442] bridge to transplant, for instance up to 30 days or more, alternatively for instance up to 60 days depending on authorization, [0443] a support in severe left ventricular failure, [0444] during high-risk revascularization procedures, for instance on coronal arteries, and/or [0445] right heart assist.
[0446] A connection to an IABP (Intra-Aortic Balloon Pump) console is possible, see for instance IABP consoles IABP7 to IABP10, i.e. at least one sensor for measuring the pulse or another signal of heart H may be used. Blood is delivered preferably in diastole of left ventricle, i.e. if heard does not pump out blood.
[0447] The proposed invention (see for instance any one of the
[0456] There may be one or several of the following technical and/or medical effect(s): [0457] pulsatile support and pumping synchronized with the heart, [0458] increased circulatory blood flow, [0459] safe, reliable and easy to use platform technology that may allow for instance the usage of an IABP (Intra-Aortic Balloon Pump) console, [0460] fast, jugular percutaneous insertion, preferably in internal jugular vein, [0461] unloading of the left ventricle, [0462] increase of coronary and end-organ (liver or kidney for instance) perfusion, [0463] low anticoagulation may be reached; anti-clotting time (ACT) may for instance be equal to or less than 180 seconds, [0464] reduction in myocardial workload, [0465] low complication rate, and [0466] a pulsatile pump in combination with an oxygenator device may result in better cleaning or better wash out of the oxygenator device and may allow a longer usage of oxygenator.
[0467] A common insertion technique may be used: [0468] only one lumen may be necessary, i.e. a single lumen cannula may be used, for instance 33 French cannula (11 mm), [0469] short straightforward insertion, [0470] up to 4 L/min (liter per minute) blood flow or more, [0471] ECG (Electrocardiography) triggered pulsation, [0472] driving by standard available IABP (Intra-Aortic Balloon Pump) consoles is possible. These consoles may already be there in many hospitals.
[0473] Furthermore, it is possible to use in all embodiments that are mentioned above an inner surface of the lumen portion that comprises a helically surface structure. The helically surface structure may have the effect that the fluid flow within the cannula is rotated as it moves through the cannula. Turbulences may be reduced thereby and/or it may be possible to reach much higher flow rates compared to cannulas that have a smooth inner surface, i.e. that do not have helical surface structures on their inner surfaces. However, it is of course possible to use cannulas without helical inner surface features, if for instance lower flow rates are necessary. The spirally turned flow and/or the rotated flow may prevent clotting of blood cells if the fluid flow comprises blood, especially in slow flow rate conditions. However, there may also be advantages if the fluid flow does not contain blood. The rotating flow may be a laminar flow.
[0474] Moreover, the cannula may be inserted endovascularly jugular and may be punctured from superior vena cava SVC or from right atrium RA transcaval to ascending aorta aAO. Alternatively, the cannula may be inserted endovascularly jugular through superior vena cava SVC and optionally into the right atrium RA and may be punctured from superior vena cava SVC or from right atrium RA transcaval to pulmonary artery PA.
[0475] In all embodiments a variable diameter arrangement may be used at the distal tip of the cannula, e.g. a cage arrangement or a balloon. It is possible to use a metal or another material than a metal for the cage arrangement, for instance a natural and/or biological material, especially cellulose, for instance cellulose that is treated to increase the hardness. Compatibility with body 100 and/or with blood may be improved thereby.
[0476] The bidirectional cannula may have only one end-hole, preferably in combination with a variable diameter arrangement around the single end-hole, for instance a cage arrangement.
[0477] The cannula(s) may be introduced jugular. This may allow usage of cannulas with greater outer diameter compared with femoral access. Furthermore, a cannula which is inserted jugular into heart H may be shorter than a cannula which is inserted femoral. Both aspects may have an influence to the pump, e.g. higher pumping volume may be possible etc.
[0478] The bidirectional cannula may have a length in the range of 40 cm (centimeters) to 50 cm, e.g. the length may be less than 80 cm and more preferably less than 60 cm. The outer diameter of the cannula(s) may be in the range of 19 Fr (French, 1 French equal to 0.33 mm (millimeter) or ⅓ mm) to 31 Fr, e.g. within the range of 21 Fr to 29 Fr. Higher flows, e.g. flows per minute, may be possible. This applies especially to the renal medical applications.
[0479] In all embodiments, optional one-way valves or other valves may be used within or at the distal end of the cannulas in addition to the one-way valves in the separated portions. These further one-way valves are backflow preventing valves which prevent that blood flows into outflow openings which are mainly used as outflow openings or that blood flows out of inflow openings which are mainly used as inflow openings. Alternatively and/or additionally, there may be one-way valves or other valves within an intermediated portions of the cannulas which have the same purpose. This is similar to flaps within the veins of the human body which flaps prevent backflow during the systole. These backflow preventing valves may be used in unidirectionally used cannula, especially in a single lumen cannula and/or in a dual lumen cannula as mentioned above.
[0480] In all embodiments one of the following methods may be used to bring or guide a guide wire and/or a catheter around or along the acute angle within the left ventricle LV, see for instance
[0481] Variant A (catching the catheter with the snare): [0482] 1) Introducing a catheter through the right atrium RA, the atrial septum AS (a puncturing step may be performed earlier or using the catheter, e.g. using a needle and/or RF (radio frequency) tip/wire within the catheter). The catheter may be introduced further through the hole (puncture) in the atrial septum AS through left atrium LA, through mitral valve MV into the left ventricle LV. [0483] 2) Introducing a snare from descending aorta AO through aortic valve AV into left ventricle LV. This step may be performed also before step 1. [0484] 3) Catching the catheter in the left ventricle LV using the snare. [0485] 4) Pulling the snare and the distal end of the catheter therewith to the aorta AO. [0486] 5) Introducing a guide wire through the catheter. [0487] 6) Forwarding the guide wire out of the distal end of the catheter. Slight loosening of the snare may be optionally performed thereby. [0488] 7) As the guide wire is already within the snare, pull back the snare to a region in which only the guide wire is located but not the catheter. [0489] 8) Fix the guide wire using the snare, e.g. contract the snare and/or tighten the snare. [0490] 9) Optional, externalizing for instance the distal end of the guide wire out of the body. This step is optionally, because the proximal end of the snare is already outside of the body. [0491] 10) Remove catheter, e.g. pull back the catheter. [0492] 11) Introduce cannula using the guide wire, e.g. pushing the cannula along and/or over the guide wire until it is on its final place.
[0493] Variant B (catching the guide wire with the snare): [0494] 1) Introducing a catheter through the right atrium RA, through the atrial septum AS (a puncturing step may be performed earlier or through catheter, use needle and/or RF (radio frequency) tip/wire).
[0495] Introducing the catheter further through left atrium LA, mitral valve MV into the left ventricle LV. [0496] 2) Introducing a guide wire through the catheter until the distal end of the guide wire comes out of the distal end of the catheter within the left ventricle LV. The RF wire may be used also as a guide wire. [0497] 3) Introducing a snare from descending aorta AO through aortic valve AV into left ventricle LV. This step may be performed before step 1 and/or before step 2. [0498] 3) Catching the distal end of the guide wire in the left ventricle LV using the snare. [0499] 4) Fixation of the guide wire using the snare. [0500] 5) Pulling the snare and the distal end of the guide wire therewith to the aorta AO. [0501] 6) Optional, externalizing guide wire by pulling it out of the body using the snare. This step is optional as the snare is already outside of the body from where it has been introduced. [0502] 7) Remove catheter, e.g. by pulling it back along the guide wire. [0503] 8) Introduce cannula over/along the guide wire until it is on place.
[0504] The following method may also be used in all corresponding embodiments for introducing a cannula jugularly transseptally: [0505] 1) Introduce a first snare into an internal jugular vein IN, for instance into the right jugular vein RJV or into the left jugular vein LJV. [0506] 2) Advancing the first snare to inferior vena cava IVC. [0507] 3) Introducing a catheter into a common femoral vein CFV (left or right). [0508] 4) Advancing the catheter through the first snare into an inferior vena cava IVC. [0509] 5) Advancing the catheter through the first snare into the vena cava VC in an antegrade fashion. [0510] 6) Advancing the catheter through the first snare into the right atrium RA in an antegrade fashion. [0511] 7) Advancing the catheter through the first snare and from the right atrium RA transseptally through the atrial septum into the left atrium LA in an antegrade fashion. Puncturing of atrial septum may have been performed earlier. Alternatively, the catheter is used to puncture the atrial septum, for instance using a needle or using a RF (radio frequency) wire/tip which is introduced trough the catheter. [0512] 8) Advancing the catheter through the first snare and advancing the catheter across the mitral valve MV and into the left ventricular outflow tract, e.g. the left ventricle LV. [0513] 9) Advancing a second snare in the ascending aorta AO catching and snaring a distal portion of the catheter (Variant A) within the left ventricle LV. The second snare may optionally be introduced through an artery, which may include, but is not limited to, a radial artery, a brachial artery, an axillary artery, a subclavian artery, a carotid artery, or common femoral artery, and advanced retrograde into the aorta AO and into the left ventricle LV. The second snare may be already introduced before the catheter is introduced. Alternatively, a guide wire may be inserted into the catheter until a distal end of the guide wire comes out of a distal opening of the catheter. This distal end of the guide wire is then caught and snared within the left ventricle (Variant B) [0514] 10) Pulling the catheter (Variant A) or the guide wire (Variant B) into the aorta AO in an antegrade fashion using the second snare. [0515] 11) In variant A, advancing a guide wire through the catheter and through the first snare in antegrade fashion to the ascending aorta AO and through the second snare. Snaring the distal end of the guide wire in variant A but not the catheter. [0516] 12) In both variants A and B remove the catheter with the guide wire remaining in the heart H and through the first snare after the catheter is removed. [0517] 13) Externalizing a proximal portion of the guide wire from femoral vein, through inferior vena cava IVC, through inferior vena cava SVC, into the internal jugular vein IN and then out of the internal jugular vein IN using the first snare, for instance left jugular vein LJV or right jugular vein RJV. In some embodiments the snare may externalize a different portion of the guide wire, for instance an intermediate portion. [0518] 14) Advancing a cannula using the guide wire and/or along and/or over the guide wire from the internal jugular vein IJV. The cannula may be any of the cannulas described in this specification or known in the art. Especially, an outer cannula may be advanced over the guide wire from the internal jugular vein IJV. An inner cannula may optionally be advanced through a port proximal of the distal end of the outer cannula. The inner cannula and the outer cannula may be positioned as described in this description, or if a single multi-lumen cannula is used, it may be positioned in a similar manner. [0519] 15) Optionally, a distal portion of the guide wire may be externalized out of the body through the artery.
[0520] This step is optional because the second snare is already externalized and may form a secure anchor for the distal portion of the guide wire.
[0521] Subclavian arteries/veins or other arteries/veins may be used for introducing the snare(s) because the snares require smaller diameters, e.g. less than 10 French (1 French equal to ⅓ mm (millimeter)) or less than 8 French, e.g. more than 3 French, compared to the diameters of the cannula(s).
[0522] In the following details of a method for puncturing transseptally through the atrial septum AS or the ventricular septum VS of the heart H or of other tissue are provided. However, other methods may be used as well, for instance using a needle.
[0523] A catheter and/or a wire may be used which has a distal tip which can be heated, for instance using RF (radio frequency) energy, alternating current (ac), direct current (dc) etc. Thus, e.g. a hole may be burned into the septum, e.g. the atrial septum AS, during puncturing, for instance using temperatures above 100° C. (degrees Celsius) or above 200° C., less than 1000° C. for instance.
[0524] The RF (radio frequency) may be in the range of 100 kHz (kilohertz) to 1 MHz (Megahertz) or in the range of 300 kHz to 600 kHz, for instance around 500 MHz, i.e. in the range of 450 kHz to 550 kHz, e.g. 468 kHz.
[0525] The power of the radio frequency energy may have a maximum of 50 Watt. A power range of 5 W (watt) to 100 W may be used, for instance a range of 10 W to 50 W.
[0526] A sinus current/voltage may be used for the RF. The sinus current/voltage may be continuous. Alternatively, a pulsed sinus current/voltage may be used for the RF.
[0527] All parameters or some of the parameters of the RF equipment may be adjustable by an operator who performs the puncturing, for instance dependent on the specifics of the septum, e.g. normal septum, fibrotic septum, aneurysmal septum, etc. Preferably, the power may be adjustable.
[0528] A solution of Baylis Medical (may be a trademark), Montreal, Canada may be used, for instance NRG® trans-septal needle or Supra Cross® RF Wire technology. RF generator of type RFP-100A or a further development of this model may be used. This RF generator uses for example a frequency of 468 kHz (kilohertz).
[0529] A single puncture of the septum AS, VS or of other tissue may be performed from a jugular access or from a femoral access or from another appropriate access using the RF energy. Smaller angles may be possible for guiding the catheter if for instance compared with a needle.
[0530] Alternatively, the RF method may be used also if two separate punctures are made in the septum. However, usage of needles is possible as well. One of the punctures using the RF method may be made through left jugular vein LJV and the other puncture of the atrial septum AS may be made through the right jugular vein RJV.
[0531] It is possible to introduce both guide wires first through the atrial septum AS. Preferably, separate holes are used for each of the guide wires. Guide wire(s) may be used which include an RF tip. Alternatively, the wire(s) having the RF tip may be pulled back and a further wire may be introduced through the catheter.
[0532] Only after both guide wires are in place, both cannulas may be introduced using a respective one of the guide wires.
[0533] Alternatively, the first puncture may be performed using RF energy or a needle. Thereafter, the first cannula for blood transfer is inserted using the first guide wire. After insertion of the first cannula, the second puncture may be made. A second guide wire or the first guide wire may be used to introduce the second cannula.
[0534] Puncturing of the atrial septum AS or of ventricular septum VS or of other tissue, for instance for transcaval access, may be assisted by at least one medical imaging method, preferably by at least two medical imaging methods.
[0535] US (ultra-sonic) echo imaging may be used to visualize the movement of heart H and the location of the valves of heart H. No dangerous radiation may result from ultra-sonic imaging. An ultra-sonic transmitter may be introduced for instance via the esophagus, e.g. trans esophagus echo (TEE) may be used.
[0536] X-ray radiation preferably in combination with fluorescence (fluoroscopy), may be used in order to visualize the location of catheters (comprising for instance at least one X-ray marker, or the devises are usually radiopaque) and/or the location of guide wire(s), snares etc.
[0537] Thus, transseptal puncturing or puncturing of other tissue may be guided by TEE and by fluoroscopy or by other imaging methods. At least two different image generating methods may be used.
[0538] In all embodiments mentioned above, it is also possible to use a soft guide wire and a stiffer guide wire which does not bend so easy if compared with the soft guide wire. The following steps may be performed, preferably in combination with snaring: [0539] 1) Introduce a soft guide wire. [0540] 2) Introduce catheter using the soft wire as a guide. [0541] 3) Optionally, remove soft wire, for instance by pulling back the soft wire out of the catheter. [0542] 4) Introduce stiffer guide wire into the catheter, e.g. there may be a change of wire from soft wire to the stiffer wire.
[0543] The catheter may be removed, e.g. pulled back. Thereafter, the stiffer wire may be used to introduce a cannula or cannulas.
[0544] Although embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations may be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the system, process, manufacture, method or steps described in the present disclosure. As one of ordinary skill in the art will readily appreciate from the disclosure of the present disclosure systems, processes, manufacture, methods or steps presently existing or to be developed later that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such systems, processes, methods or steps. Further, it is possible to combine embodiments mentioned in the first part of the description with examples of the second part of the description which relates to