Heart failure assistance

Abstract

The present disclosure provides a solution for assisting cardiac circulation of a subject. The solution of the present disclosure provides an approach in which a mechanical circulatory support (MCS) device is either implanted in the iliac fossa extraperitoneally or maintained external to the body of the subject and the inflow cannula allowing flow of blood therethrough from a damaged heart chamber of the subject passes through an iliac blood vessel of the subject and an intermediate blood vessel connecting the iliac blood vessel and the heart until reaching the heart. In the embodiments where the MCS device is maintained externally to the body of the subject, typically the inflow cannula also passes through a femoral blood vessel before passing through the iliac blood vessel, namely after entering into the body of the subject, the first blood vessel it is introduced into is the femoral blood vessel.

Description

[0001] HEART FAILURE ASSISTANCE

[0002] TECHNOLOGICAL FIELD

[0003] The present disclosure is in the cardiological field, in particular in the heart failure procedures.

[0004] GENERAL DESCRIPTION

[0005] The present disclosure provides a solution for assisting cardiac circulation of a subject. The solution of the present disclosure provides an approach in which a mechanical circulatory support (MCS) device is either implanted in the iliac fossa extraperitoneally or maintained external to the body of the subject and the inflow cannula allowing flow of blood therethrough from a damaged heart chamber of the subject passes through an iliac blood vessel of the subject and an intermediate blood vessel connecting the iliac blood vessel and the heart until reaching the heart. In the embodiments where the MCS device is maintained externally to the body of the subject, typically the inflow cannula also passes through a femoral blood vessel before passing through the iliac blood vessel, namely after entering into the body of the subject, the first blood vessel it is introduced into is the femoral blood vessel.

[0006] The iliac fossa space provides sufficient room for MCS device to be left inside a patient, in the embodiments that the MCS is implanted in the iliac fossa space, and there are relatively large veins and arteries, such as iliac blood vessels that continue to either the aorta or the inferior vena cava, that are accessible from the iliac space to allow passing cannulas / catheters to the heart and lungs-related blood vessels (such as the pulmonary artery). Implanting the MCS device in the iliac space provides a solution to a plurality of heart conditions, including left heart failure, right heart failure and lung failure. Therefore, one of the approaches of the present disclosure provides a solution for implanting left ventricle assist device (LVAD) and right ventricle assist device (RVAD). Each scenario requires a different cannulation solution through different blood vessels for allowing the suction of blood from the required blood vessel or heart chamber to the MCS device and the outflow of blood from the MCS device to the required blood vessel or heart chamber. As mentioned above, the present disclosure provides also a solution in which the MCS device is not implanted in the body of the subject and is maintained externally. The cannulation solution may be generally the same to the solution involving implantation of the MCS device in the iliac fossa space, and optionally adding a part of the cannulation that passes through a femoral blood vessel.

[0007] The term “iliac blood vessel” encompasses an iliac vein or an iliac artery.

[0008] The term “femoral blood vessel” encompasses a femoral vein or a femoral artery.

[0009] Therefore, an aspect of the present disclosure provides a method for assisting cardiac circulation of a subject. The method comprises fluidically coupling an inlet of a mechanical circulatory support (MCS) device with a damaged heart chamber of the subject or a blood vessel feeding blood the damaged heart chamber for receiving an inflow blood from the damaged heart chamber or the blood vessel feeding blood the damaged heart chamber to the MCS device. The method further comprises fluidically coupling an outlet of the MCS device with a desired blood vessel to allow outflow of blood from the MCS to the desired blood vessel. A desired blood vessel should be understood as a selected or a receiving blood vessel that receives the blood that outflows from the MCS. Said fluidically coupling an inlet of the MCS device with a damaged heart chamber of the subject comprises introducing a distal end of an inflow cannula into the damaged heart chamber of the subject, the inflow cannula passing at least through the following: an iliac blood vessel selected from an iliac artery and an iliac vein, an intermediate blood vessel between the iliac blood vessel and a heart of the subject selected from an inferior vena cava and an aorta. The selections of the iliac blood vessel and the intermediate blood vessel depend on the condition of the subject and the specific damaged heart chamber. In some embodiments, a further passage between chambers of the heart is required in order to reach the damaged heart chamber. Namely, the intermediate blood vessel reaches a heart chamber that is not the damaged heart chamber, and the cannula further extends through the heart to cross between heart chambers until reaching the damaged heart chamber. The inflow cannula extends between said distal end and a proximal end being coupled to the inlet of the MCS device to allow suction of blood from the damaged heart chamber to the MCS device. Said fluidically coupling an outlet of said MCS device with a desired blood vessel comprises coupling a distal end of an outflow cannula with the desired blood vessel, a proximal end of said outflow cannula is coupled with the outlet of said MCS device to allow outflow of blood from the MCS towards the desired blood vessel.

[0010] It is to be noted that any combination of the described embodiments with respect to any aspect of this present disclosure is applicable. In other words, any aspect of the present disclosure can be defined by any combination of the described embodiments.

[0011] In some embodiments, the method further comprises implanting the mechanical circulatory support (MCS) device or at least a part thereof in the extraperitoneal space.

[0012] In some embodiments of the method, said implanting comprises placing a pump element of the MCS device in the extraperitoneal space.

[0013] In some embodiments, the method further comprises maintaining the MCS device external to a body of the subject. Namely, in this embodiment, the MCS device is not implanted and is maintained external to the body of the subject. The inflow cannula further passes through a femoral blood vessel selected from a femoral artery and a femoral vein. The selection of the femoral blood vessel depends on the specific condition and the selected configuration of the solution. Therefore, in this embodiment the inflow cannula passes through the femoral blood vessel, the iliac blood vessel, the intermediate blood vessel and then reaching the heart, which may be a different chamber of the heart than the damaged heart chamber requiring an additional passage until reaching the damaged heart chamber, e.g. through the mitral valve, the foramen ovale, or the tricuspid valve.

[0014] Another aspect of the present disclosure provides a method for assisting cardiac circulation of a subject. The method comprises: implanting a mechanical circulatory support (MCS) device or at least a part thereof in the extraperitoneal space (the term "extraperitoneal space" interchangeable with the terms "iliac space" or " iliac fossa extraperitoneal"); fluidically coupling, directly or indirectly, an inlet of the MCS device with a damaged or weakened heart chamber of the subject or a blood vessel feeding blood the damaged heart chamber for receiving an inflow blood from said damaged heart chamber or said blood vessel feeding blood the damaged heart chamber to the MCS device; and fluidically coupling, directly or indirectly, an outlet of MCS device with a desired blood vessel to allow outflow of blood from the MCS to the desired blood vessel.

[0015] As noted above, any combination of the below-described embodiments may apply to any of the two above-described aspects of the method.

[0016] In some embodiments of the method, the damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the iliac artery. Said fluidically coupling an inlet of the MCS device with a damaged heart chamber of the subject comprises introducing a distal end of an inflow cannula, that can be in the form of a catheter, into the LV of the subject, the inflow cannula passes at least through an iliac vein, being the iliac blood vessel, an inferior vena cava, being the intermediate blood vessel, a right atrium, a left atrium (LA), wherein the inflow cannula extends transeptally between the right atrium and the LA, and the mitral valve (MV) of the subject. When the MCS device is maintained external to the body, the inflow cannula further passes through the femoral vein before passing through the iliac vein. The inflow cannula extending between said distal end and a proximal end being coupled to the inlet of the MCS device to allow suction of blood from the LV to the MCS device. Said fluidically coupling an outlet of MCS device with a desired blood vessel comprises coupling a distal end of an outflow cannula with an iliac artery, being the desired blood vessel of the subject. A proximal end of said outflow cannula is coupled with the outlet of said MCS device to allow outflow of blood from the MCS towards the iliac artery.

[0017] In some embodiments of the method, the damaged heart chamber is the right ventricle (RV) and said desired blood vessel is the pulmonary artery.

[0018] In some embodiments, the method further comprises inserting a catheter, constituting said inflow cannula and said outflow cannula, into the pulmonary artery of the subject. Namely, the catheter serves for the two purposes, allowing an inflow of blood therethrough going the MCS device and allowing outflow of blood discharged from the MCS device therethrough. Therefore, the catheter forms or comprises the inflow cannula and the outflow cannula by having two separated flow paths therein. The catheter passes through an iliac vein, being the iliac blood vessel inferior vena cava, being the intermediate blood vessel, right atrium and then a right ventricle. When the MCS device is maintained external to the body, the inflow cannula further passes through the femoral vein. Therefore, the catheter extends from the iliac vein, through the vena cava to the right atrium and into the pulmonary artery. Said catheter is coupled to the inlet and the outlet of the MCS device, namely a first part of the catheter is coupled to the inlet and a second part of the catheter is coupled to the outlet. A first portion of the catheter is configured for allowing a flow of blood, by the suction operation of the MCS device, from either (i) the inferior vena cava, (ii) the right atrium, or (iii) both the inferior vena cava and the right atrium, and in the embodiments that the MCS device is external to the body, optionally also from the femoral vein, to the inlet of the MCS device, thereby performing said fluidically coupling an inlet of the MCS device with a damaged heart chamber of the subject or a blood vessel feeding the damaged hear chamber with blood, serving its purpose as an inflow cannula. Such a catheter can be a dual lumen catheter, in which an external lumen is configured to receive blood from the heart chamber or blood vessel, typically through perforations in the external surface of the catheter, and an internal lumen that is configured to allow outflow of blood to the desired blood vessel. The external lumen is in fluidic communication with the first part and the internal lumen is in fluidic communication with the second part.

[0019] In some embodiments of the method, a second portion of the catheter is configured for allowing a flow of blood, by the pumping operation of the MCS device, from the MCS device to the pulmonary artery thereby performing said fluidically coupling an outlet of MCS device with a desired blood vessel, serving its purpose as an outflow cannula.

[0020] In some embodiments of the method, the damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the aorta, or in some specific embodiments, the ascending aorta.

[0021] In some embodiments, the method further comprises inserting a catheter, constituting said inflow cannula and said outflow cannula, into the LV of the subject. Namely, the catheter serves for the two purposes, allowing an inflow of blood therethrough going the MCS device and allowing outflow of blood discharged from the MCS device therethrough. Therefore, the catheter forms or comprises the inflow cannula and the outflow cannula by having two separated flow paths therein. The catheter passes through an iliac artery, being the iliac blood vessel, an aorta, being the intermediate blood vessel, and an aortic valve of the subject, and when the MCS device is external to the body, the inflow cannula further passes through the femoral vein. Namely, the catheter extends from the iliac artery, through the aorta to the LV. Said catheter is coupled to the inlet and the outlet of the MCS device due to the reason that it functions both as an inflow cannula and an outflow cannula. Namely, a first part of the catheter is coupled to the inlet and a second part of the catheter is coupled to the outlet. A first portion of the catheter is configured for allowing a flow of blood, by the suction operation of the MCS device, from LV to the inlet of the MCS device, thereby performing said fluidically coupling an inlet of the MCS device with a damaged heart chamber of the subject or a blood vessel feeding the damaged hear chamber with blood. Such a catheter can be a dual lumen catheter, in which an external lumen is configured to receive blood from the heart chamber or blood vessel, typically through perforations in the external surface of the catheter, and an internal lumen that is configured to allow outflow of blood to the desired blood vessel. The external lumen is in fluidic communication with the first part and the internal lumen is in fluidic communication with the second part.

[0022] In some embodiments of the method, a second portion of the catheter is configured for allowing a flow of blood, by the pumping operation of the MCS device, from the MCS device to the aorta thereby performing said fluidically coupling an outlet of MCS device with a desired blood vessel.

[0023] In some embodiments of the method, said MCS device is selected from any one of: a left ventricular assist device (LVAD), temporary ventricle assist device (VAD), right ventricular assist device (RVAD) and extracorporeal membrane oxygenation (ECMO).

[0024] In some embodiments of the method, a distal end portion of the inflow cannula or said second portion is formed with perforations.

[0025] In some embodiments of the method, the length of the outflow cannula is ranged between 4-40 cm in order to allow the coupling defined by the intended use of the method.

[0026] In some embodiments of the method, the length of the inflow cannula is between 80-160 cm in order to allow the coupling defined by the intended use of the method.

[0027] In some embodiments of the method, the size of a motor of the MCS device is between 150 cm3to 700 cm3.

[0028] In some embodiments of the method, the diameter of the inflow cannula is between 14-28 Fr (French scale).

[0029] In some embodiments of the method, the diameter of the outflow cannula is between 13-24 Fr (French scale).

[0030] Yet another aspect of the present disclosure provides a kit for use in a method for assisting cardiac circulation of a subject. The kit comprises an inflow cannula extending between an inflow cannula proximal end, configured to be coupled to an inlet of a mechanical circulatory support (MCS) device, and an inflow cannula distal end, configured to be placed in a damaged or weakened heart chamber of the subject or a blood vessel feeding blood to the damaged heart chamber to allow suction of blood from the damaged heart chamber or the blood vessel feeding blood to the damaged heart chamber to the MCS device. The kit further comprises an outflow cannula extending between an outflow cannula proximal end, configured to be coupled to an outlet of a MCS device, and an outflow cannula distal end configured to be coupled to or inserted into a desired blood vessel to allow outflow of blood from the MCS device to the desired blood vessel. The inflow and the outflow cannulas are dimensioned so as to support the unique configuration employed by this kit.

[0031] In some embodiments, the kit is for use in a method according to any one of the above-described embodiments of the method or any combination thereof.

[0032] In some embodiments of the kit, said inflow cannula and said outflow cannula are part of a catheter, wherein said catheter comprises (i) a first portion that is configured for allowing suction of blood from said damaged heart chamber or the blood vessel feeding blood to the damaged heart chamber to the MCS device, and (ii) a second portion that is configured for feeding of blood from the MCS device to the desired blood vessel.

[0033] In some embodiments of the kit, said damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the aorta.

[0034] In some embodiments of the kit, the damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the iliac artery.

[0035] In some embodiments of the kit, the damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the aorta.

[0036] In some embodiments, the kit further comprises connectors for allowing said coupling of the inflow cannula proximal end to the inlet of the MCS device and the outflow cannula proximal end to the outlet of the MCS device.

[0037] In some embodiments, the kit further comprises said MCS device.

[0038] In some embodiments of the kit, said MCS device is selected from any one of: a left ventricular assist device (LVAD), right ventricle assist device (RVAD), temporary ventricle assist device (VAD) and extracorporeal membrane oxygenation (ECMO).

[0039] In some embodiments of the kit, a distal end portion of said inflow cannula is formed with perforations.

[0040] In some embodiments, the kit further comprises a septal fixation unit for fixing the inflow cannula to the septum when the inflow cannula is transseptal.

[0041] In some embodiments of the kit, the septal fixation unit comprises two fixation members, each member comprises an opening for receiving the inflow cannula therethrough.

[0042] In some embodiments of the kit, each fixation member comprises a fixation or anchoring arrangement for fixing or anchoring to the septum. In some embodiments of the kit, each fixation member is formed of biocompatible material, such as nitinol.

[0043] In some embodiments of the kit, each fixation member is formed of a braided structure.

[0044] In some embodiments of the kit, each fixation member is formed of a stented structure.

[0045] In some embodiments of the kit, each fixation member comprises a fixation arrangement in the form of stent barbs.

[0046] In some embodiments of the kit, the length of the outflow cannula is ranged between 4-40 cm in order to allow the coupling defined by the intended use of the kit.

[0047] In some embodiments of the kit, the length of the inflow cannula is between 80- 160 cm in order to allow the coupling defined by the intended use of the kit.

[0048] In some embodiments of the kit, the size of a motor of the MCS device is between 150 cm3to 700 cm3.

[0049] In some embodiments of the kit, the diameter of the inflow cannula is between 14-28 Fr (French scale).

[0050] In some embodiments of the kit, the diameter of the outflow cannula is between 13-24 Fr (French scale).

[0051] Yet another aspect of the present disclosure provides a method for assisting in cardiac circulation of a subject. The method comprises fluidically coupling a first part of an inflow cannula with a pulmonary vein of the subject, the fluidically coupling can be made to one or more pulmonary veins, and fluidically coupling a second part of the inflow cannula with an inlet of a mechanical circulatory support (MCS) device to allow suction of blood from the right pulmonary vein into the MCS device; fluidically coupling a first part of an outflow cannula with a part of an aorta of the subject and fluidically coupling a second part of the outflow cannula with an outlet of the MCS device to allow outflow of blood from the MCS device towards the aorta. The MCS device is positioned, i.e. implanted at the right hemithorax.

[0052] In some embodiments of the method, the part of the aorta of the subject is a part of the ascending aorta.

[0053] In some embodiments, the method further comprises positioning, and therefore, implanting, the MCS device at the right hemithorax. In some embodiments of the method, the MCS device is a left ventricle assist device (LVAD).

[0054] In some embodiments of the method, the pulmonary vein is a right pulmonary vein. It is to be noted that the fluidically coupling can be made to one or both right pulmonary veins.

[0055] In some embodiments of the method, the length of each of the inflow cannula and the outflow cannula is ranged between 4-40 cm in order to allow the coupling defined by the intended use according to the method.

[0056] In some embodiments of the method, the size of a motor of the MCS device is between 150 cm3to 700 cm3so as to fit at the right hemithorax.

[0057] In some embodiments of the method, the diameter of the inflow cannula is between 8-24 Fr (French scale).

[0058] In some embodiments of the method, the diameter of the outflow cannula is between 15-24 Fr (French scale).

[0059] Y et another aspect of the present disclosure provides a kit or a system for assisting in cardiac circulation of a subject. It is to be noted that any reference to a kit with respect to this aspect applies also to a system and vice versa. The kit or the system comprises a mechanical circulatory support (MCS) device intended to be placed in the hemithorax. The kit or the system further comprises an inflow cannula an inflow cannula having a first part and a second part, the first part of the inflow cannula is configured to be fluidically coupled to a pulmonary vein, the fluidically coupling can be made to one or more pulmonary veins, and the second part of the inflow cannula is configured to be fluidically coupled to an inlet of the MCS device to allow suction of blood from the right pulmonary vein into the MCS device. The kit or the system further comprises an outflow cannula having a first part and a second part, the first part of the outflow cannula is configured to be fluidically coupled to a part of an aorta of the subject and the second part of the outflow cannula is configured to be coupled to an outlet of the MCS device to allow outflow of blood from the MCS towards the aorta. The inflow and the outflow cannulas are dimensioned so as to support the unique configuration employed by this kit.

[0060] In some embodiments of the kit or the system, the MCS device is a left ventricle assist device.

[0061] In some embodiments of the kit or the system, the MCS device is intended to be placed in the right hemithorax, and therefore, to be implanted therein. In some embodiments, the kit or the system further comprises coupling elements for fluidically coupling the inflow cannula and the outflow cannula with the pulmonary vein and the part of the aorta, respectively.

[0062] In some embodiments of the kit or the system, the pulmonary vein is a right pulmonary vein.

[0063] In some embodiments, the kit or the system is for use in a method for assisting in cardiac circulation of the subject, wherein the method is the method defined in any of the above-described embodiments.

[0064] In some embodiments of the kit, the length of each of the inflow cannula and the outflow cannula is ranged between 4-40 cm in order to allow the coupling defined by the intended use of the kit.

[0065] In some embodiments of the kit, the size of a motor of the MCS device is between 150 cm3to 700 cm3so as to fit at the right hemithorax.

[0066] In some embodiments of the kit, the diameter of the inflow cannula is between 8- 24 Fr (French scale).

[0067] In some embodiments of the kit, the diameter of the outflow cannula is between 15-24 Fr (French scale).

[0068] BRIEF DESCRIPTION OF THE DRAWINGS

[0069] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0070] Fig. 1 is a schematic illustration of a non-limiting example showing the elements of the kit of the present disclosure implanted in a human body according to a method of the present disclosure. This figure exemplifies a new solution for treating a subject suffering from left heart failure.

[0071] Fig. 2 is a schematic illustration of a non-limiting example showing the elements of the kit of the present disclosure implanted in a human body according to a method of the present disclosure. This figure exemplifies a new solution for treating a subject suffering from right heart failure.

[0072] Fig. 3 is a schematic illustration of a non-limiting example showing the elements of the kit of the present disclosure implanted in a human body according to a method of the present disclosure. This figure exemplifies a new solution for treating a subject suffering from left heart failure.

[0073] Figs. 4A-4E are schematic illustrations exemplifying a fixation structure and technique for fixing the transseptal cannula to the septum. Fig. 4A shows schematically the cannula crossing the septum and the septal fixation fixing the cannula to the septum; Figs. 4B-4C exemplify a braided fixation structure, wherein Fig. 4A is a cross-sectional view showing the septum and the transseptal cannula fixed to it with the fixation structure and Fig. 4C is a perspective view of the braided fixation structure; Figs. 4D-4E exemplify a stented fixation structure, wherein Fig. 4D is a cross-sectional view showing the septum and the transseptal cannula fixed to it with the fixation structure and Fig. 4E is a front view of the stented fixation structure.

[0074] Fig. 5 is a schematic illustration of a non-limiting example of an embodiment of a setup of a cardiac assisting system according to an aspect of the present disclosure.

[0075] DETAILED DESCRIPTION

[0076] The following figures are provided to exemplify embodiments and realization of the invention of the present disclosure.

[0077] Reference is first made to Fig. 1, which exemplifies the implantation of left ventricle assist device (LVAD) in the iliac fossa extraperitoneal according to an embodiment of the method of the present disclosure. In this example, the mechanical circulatory support (MCS) device is a LVAD 100 that is placed in the iliac fossa extraperitoneal. An inflow cannula 102 is fluidically coupled to an inlet of the LVAD 100 in its proximal end 104 and extends through the iliac vein, the inferior vena cave, the right atrium, transeptally to the left atrium and then through the mitral valve into the left ventricle. Therefore, the distal end 106 of the inflow cannula 102 is disposed in the left ventricle to allow suction of blood from the left ventricle to the LVAD 100. A distal portion 108 of the inflow cannula 102 is formed with perforations 110 that are configured to allow suction of blood from the left ventricle and the left atrium. Namely, the perforations extend from the distal end 106 to a certain position of the inflow cannula 102 that is intended to be located in the left atrium. An outflow cannula 112 extends between a proximal end 114, that is configured to be fluidically coupled to the outlet of the LVAD 100, and a distal end 116 that is configured to be fluidically coupled to or inserted into the iliac artery to allow outflow of blood from the LVAD 100 to the iliac artery.

[0078] In some embodiments, the LVAD is not implanted in the iliac fossa space and is maintained externally to the body of the subject. Therefore, the entering location of the inflow cannula 102 in this embodiment is at the femoral vein, which is located below the iliac vein, namely a more bottom part of the subject’s body. In this embodiment, the inflow cannula 102 enters the femoral vein and passes through the iliac vein and further as shown in Fig. 1.

[0079] Reference is now being made to Fig. 2, which exemplifies the implantation of right ventricle assist device (RVAD) in the iliac fossa extraperitoneal according to an embodiment of the method of the present disclosure. In this example, the MCS device is a RVAD 200 that is placed in the iliac fossa extraperitoneal. A two-lumen catheter 201 is fluidically coupled to the inlet and the outlet of the RVAD 200 and extends through the iliac vein, the inferior vena cava, the right atrium, the right ventricle and to the pulmonary artery in its distal end 216. The two-lumen catheter 201 comprises an external lumen 202 that serves as an inflow cannula and is coupled at its proximal end 204 to the inlet of the RVAD 200. The external walls of the external lumen are formed with perforations 210 to allow suction of blood from the iliac vein, the inferior vena cava and the right atrium into the RVAD 200. The distal end 208 of the external lumen 202 is located in the right atrium. The two-lumen catheter 201 comprises an internal lumen 212 that serves as an outflow cannula and is coupled at its proximal end 214 to the outlet of the RVAD 200. The distal end 216 of the internal lumen 212 is located in the pulmonary artery to allow outflow of blood from the RVAD 200 to the pulmonary artery.

[0080] In some embodiments, the RVAD is not implanted in the iliac fossa space and is maintained externally to the body of the subject. Therefore, the entering location of the two-lumen catheter 201 in this embodiment is at the femoral vein, which is located below the iliac vein, namely a more bottom part of the subject’s body. In this embodiment, the two-lumen catheter 201 enters the femoral vein and passes through the iliac vein and further as shown in Fig. 2. Reference is now being made to Fig. 3, which exemplifies the implantation of LVAD in the iliac fossa extraperitoneal according to an embodiment of the method of the present disclosure. In this example, the MCS device is a LVAC 300, which is a left ventricle -aorta catheter that is placed in the iliac fossa extraperitoneal. A two-lumen catheter 301 is fluidically coupled to the LVAC 300 at its proximal end 304 and extends through the iliac artery, the aorta into the left ventricle in its distal end 306. The distal end portion 308 is formed with first set of perforations 310 that are configured to allow suction of blood from the left ventricle to the LVAC 300. An intermediate portion 311 of the catheter 301 is formed with a second set of perforations 313 to allow outflow of the suctioned blood from the LVAC to the aorta, typically the ascending aorta.

[0081] In some embodiments, the LVAC is not implanted in the iliac fossa space and is maintained externally to the body of the subject. Therefore, the entering location of the two-lumen catheter 301 in this embodiment is at the femoral artery, which is located below the iliac artery, namely a more bottom part of the subject’s body. In this embodiment, the two-lumen catheter 301 enters the femoral artery and passes through the iliac artery and further as shown in Fig. 3.

[0082] In the embodiments where the cannula or the catheter is transseptal, namely it crosses the septum and therefore it may require the fixation of the cannula or the catheter to the septum to maintain it in position. Figs. 4A-4E exemplify fixation solutions of the cannula to the septum. Fig. 4A shows the cannula crossing the septum and being fixed by a septal fixation. Figs. 4B-4E show two examples of realization of the septal fixation.

[0083] The first example is exemplified in Figs. 4B-4C, in which the septal fixation comprises two fixation members of a braided structure. Each member is annular and is configured to be placed on one side of the septum. Each member comprises an opening that is configured to receive, typically in a tight manner, the cannula. Therefore, the fixation members are anchored or fixed to the septum from both sides and the transseptal cannula extend through the two openings and thereby being fixed to the fixation members and therefore to the septum. The fixation members are made of biocompatible materials such as nitinol. The material that forms the fixation members is selected so as to sustain for a long period of time in the physiological environment of the heart. The fixation members can be optionally covered with a tissue-enhancing material to enhance tissue growth on it. The second example is exemplified in Figs. 4D-4E, in which the septal fixation comprises two fixation members of a stented structure. Each member is configured to be placed on one side of the septum. Each member comprises an opening that is configured to receive, typically in a tight manner, the cannula. Therefore, the fixation members are anchored or fixed to the septum from both sides and the transseptal cannula extend through the two openings and thereby being fixed to the fixation members and therefore to the septum. The anchoring, for example, can be performed by fixation barbs. The fixation members are made of biocompatible materials such as nitinol. The material that forms the fixation members is selected so as to sustain for a long period of time in the physiological environment of the heart. The fixation members can be optionally covered with a tissue-enhancing material to enhance tissue growth on it.

[0084] Reference is now made to Fig. 5, which is a schematic illustration of a nonlimiting example of an embodiment of a setup of a cardiac assisting system according to an aspect of the present disclosure. The example of Fig. 5 is intended to be used in cases of a left ventricular dysfunction. In this example, a left ventricle assist device (LVAD) 550 is implanted in the right hemithorax of the subject. The LVAD 550 receives oxygenated blood from the right pulmonary veins, via an inflow cannula 552 that is coupled at a first end 554 to the right pulmonary veins and at a second end 556 to the inlet 558 of the LVAD 550. The LVAD 550 is pumping the oxygenated blood to the ascending aorta, via an outflow cannula 560 that is coupled at a first end 562 to the outlet 564 of the LVAD 550 and at a second end 566 to the ascending aorta. By setting the system as exemplified in Fig. 5, the entire LVAD system can be implanted efficiently in the subject’s body, specifically in the right hemithorax.

Claims

CLAIMS:

1. A method for assisting cardiac circulation of a subject, comprising: fluidically coupling an inlet of a mechanical circulatory support (MCS) device with a damaged heart chamber of the subject or a blood vessel feeding blood the damaged heart chamber for receiving an inflow blood from the damaged heart chamber or the blood vessel feeding blood the damaged heart chamber to the MCS device; fluidically coupling an outlet of the MCS device with a desired blood vessel to allow outflow of blood from the MCS to the desired blood vessel; wherein said fluidically coupling an inlet of the MCS device with a damaged heart chamber of the subject comprises introducing a distal end of an inflow cannula into the damaged heart chamber of the subject, the inflow cannula passing at least through the following: an iliac blood vessel selected from an iliac artery and an iliac vein, an intermediate blood vessel between the iliac blood vessel and a heart of the subject selected from an inferior vena cava and an aorta; the inflow cannula extending between said distal end and a proximal end being coupled to the inlet of the MCS device to allow suction of blood from the damaged heart chamber to the MCS device; wherein said fluidically coupling an outlet of said MCS device with a desired blood vessel comprises coupling a distal end of an outflow cannula with the desired blood vessel, a proximal end of said outflow cannula is coupled with the outlet of said MCS device to allow outflow of blood from the MCS towards the desired blood vessel.

2. The method of claim 1, comprising: implanting the mechanical circulatory support (MCS) device or at least a part thereof in the extraperitoneal space.

3. The method of claim 2, wherein said implanting comprises placing a pump element of the MCS device in the extraperitoneal space.

4. The method of claim 1, comprising maintaining the MCS device external to a body of the subject; wherein the inflow cannula further passes through a femoral blood vessel selected from a femoral artery and a femoral vein.

5. The method of any one of claims 1-4, wherein the damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the iliac artery; wherein said fluidically coupling an inlet of the MCS device with a damaged heart chamber of the subject comprises introducing a distal end of an inflow cannula into theLV of the subject, the inflow cannula passing at least through an iliac vein, an inferior vena cava a right atrium, a left atrium (LA), and a mitral valve (MV) of the subject; wherein said fluidically coupling an outlet of MCS device with a desired blood vessel comprises coupling a distal end of an outflow cannula with an iliac artery of the subject, a proximal end of said outflow cannula is coupled with the outlet of said MCS device to allow outflow of blood from the MCS towards the iliac artery.

6. The method of any one of claims 1-4, wherein the damaged heart chamber is the right ventricle (RV) and said desired blood vessel is the pulmonary artery.

7. The method of claim 6, comprising inserting a catheter, constituting said inflow cannula and said outflow cannula, into the pulmonary artery of the subject through an iliac vein, inferior vena cave, right atrium and right ventricle of the subject, wherein said catheter is coupled to the inlet and the outlet of the MCS device; wherein a first portion of the catheter is configured for allowing a flow of blood from either the inferior vena cava, the right atrium, or both the inferior vena cava and the right atrium to the inlet of the MCS device, thereby performing said fluidically coupling an inlet of the MCS device with a damaged heart chamber of the subject or a blood vessel feeding the damaged heart chamber with blood.

8. The method of claim 7, wherein a second portion of the catheter is configured for allowing a flow of blood from the MCS device to the pulmonary artery thereby performing said fluidically coupling an outlet of MCS device with a desired blood vessel.

9. The method of any one of claims 1-4, wherein the damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the aorta.

10. The method of claim 9, comprising inserting a catheter, constituting said inflow cannula and said outflow cannula, into the LV of the subject through an iliac artery, an aorta and an aortic valve of the subject, wherein said catheter is coupled to the inlet and the outlet of the MCS device; wherein a first portion of the catheter is configured for allowing a flow of blood from LV to the inlet of the MCS device thereby performing said fluidically coupling an inlet of the MCS device with a damaged heart chamber of the subject or a blood vessel feeding the damaged hear chamber with blood.

11. The method of claim 10, wherein a second portion of the catheter is configured for allowing a flow of blood from the MCS device to the aorta thereby performing said fluidically coupling an outlet of MCS device with a desired blood vessel.

12. The method of any one of claims 1-11, wherein said MCS device is selected from any one of: a left ventricular assist device (LVAD), temporary ventricle assist device (VAD), right ventricular assist device (RVAD) and extracorporeal membrane oxygenation (ECMO).

13. The method of any one of claims 1-12, wherein a distal end portion of the inflow cannula or said second portion is formed with perforations.

14. A kit for use in a method for assisting cardiac circulation of a subject, the kit comprising: an inflow cannula extending between an inflow cannula proximal end, configured to be coupled to an inlet of a mechanical circulatory support (MCS) device, and an inflow cannula distal end, configured to be placed in a damaged heart chamber of the subject or a blood vessel feeding blood to the damaged heart chamber to allow suction of blood from the damaged heart chamber or the blood vessel feeding blood to the damaged heart chamber to the MCS device; an outflow cannula extending between an outflow cannula proximal end, configured to be coupled to an outlet of a MCS device, and an outflow cannula distal end configured to be coupled to or inserted into a desired blood vessel to allow outflow of blood from the MCS device to the desired blood vessel; wherein said method is the method defined in any one of claims 1-13.

15. The kit of claim 14, wherein said inflow cannula and said outflow cannula are part of a catheter, wherein said catheter comprises (i) a first portion that is configured for allowing suction of blood from said damaged heart chamber or the blood vessel feeding blood to the damaged heart chamber to the MCS device, and (ii) a second portion that is configured for feed of blood from the MCS device to the desired blood vessel.

16. The kit of claim 14 or 15, characterized by one of the following:(1) said damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the aorta;(2) said damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the iliac artery; or(3) said damaged heart chamber is the left ventricle (LV) and said desired blood vessel is the aorta.

17. The kit for use of any one of claims 14-16, comprising connectors for allowing said coupling of the inflow cannula proximal end to the inlet of the MCS device and the outflow cannula proximal end to the outlet of the MCS device.

18. The kit for use of any one of claims 14-17, comprising said MCS device.

19. The kit for use of any one of claims 14-18, wherein said MCS device is selected from any one of: a left ventricular assist device (LVAD), right ventricle assist device (RVAD), temporary ventricle assist device (VAD) and extracorporeal membrane oxygenation (ECMO).

20. The kit for use of any one of claims 14-19, wherein a distal end portion of said inflow cannula is formed with perforations.

21. The kit for use of any one of claims 14-20, comprising a septal fixation unit for fixing the inflow cannula to the septum when the inflow cannula it transseptal.

22. The kit for use of claim 21 , wherein the septal fixation unit comprises two fixation members, each member comprises an opening for receiving the inflow cannula therethrough.

23. The kit for use of claim 22, wherein each fixation member comprises a fixation or anchoring arrangement for fixing or anchoring to the septum.

24. The kit for use of any one of claims 21-23, wherein each fixation member is formed of biocompatible material.

25. The kit for use of any one of claims 21-24, wherein each fixation member is formed of a braided structure.

26. The kit for use of any one of claims 21-24, wherein each fixation member is formed of a stented structure.

27. The kit for use of claim 26, wherein each fixation member comprises a fixation arrangement in the form of stent barbs.

28. A method for assisting in cardiac circulation of a subject, comprising: fluidically coupling a first part of an inflow cannula with a pulmonary vein of the subject and fluidically coupling a second part of the inflow cannula with an inlet of a mechanical circulatory support (MCS) device to allow suction of blood from the right pulmonary vein into the MCS device; fluidically coupling a first part of an outflow cannula with a part of an aorta of the subject and fluidically coupling a second part of the outflow cannula with an outlet of the MCS device to allow outflow of blood from the MCS towards the aorta;wherein the MCS device is positioned at the right hemithorax.

29. The method of claim 28, wherein the part of the aorta of the subject is a part of the ascending aorta.

30. The method of claim 28 or 29, comprising positioning the MCS device at the right hemithorax.

31. The method of any one of claims 28-30, wherein the MCS device is a left ventricle assist device (LVAD).

32. The method of any one of claims 28-31, wherein the pulmonary vein is a right pulmonary vein.

33. A kit or a system for assisting in cardiac circulation of a subject, the kit comprising: a mechanical circulatory support (MCS) device intended to be placed in the hemithorax; an inflow cannula an inflow cannula having a first part and a second part, the first part of the inflow cannula is configured to be fluidically coupled to a pulmonary vein and the second part of the inflow cannula is configured to be fluidically coupled to an inlet of the MCS device to allow suction of blood from the right pulmonary vein into the MCS device; an outflow cannula having a first part and a second part, the first part of the outflow cannula is configured to be fluidically coupled to a part of an aorta of the subject and the second part of the outflow cannula is configured to be coupled to an outlet of the MCS device to allow outflow of blood from the MCS towards the aorta.

34. The kit or system of claim 33, wherein the MCS device is a left ventricle assist device.

35. The kit or system of claim 33 or 34, wherein the MCS device is intended to be placed in the right hemithorax.

36. The kit or system of any one of claims 33-35, comprising coupling elements for fluidically coupling the inflow cannula and the outflow cannula with the pulmonary vein and the part of the aorta, respectively.

37. The kit or system of any one of claims 33-36, wherein the pulmonary vein is a right pulmonary vein.

38. The kit or system of any one of claims 33-37, for use in a method for assisting in cardiac circulation of the subject, wherein the method is the method defined in any one of claims28-32.

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