SYSTEM AND METHOD FOR ASSISTING FLOW OF A FLUID IN A VASCULAR SYSTEM OF A MAMMALIAN BODY

Abstract

System for assisting vascular fluid flow body comprising: Fluid pump having an inlet for fluid in the vascular system to enter and an outlet for discharging pumped fluid into the vascular system at a fluid pump outlet pressure. Occluder placed into the vascular system at a location downstream of the outlet of the fluid pump. Occluder having a configuration in which the occluder occludes the vascular system and a configuration in which pumped is capable of flowing past the occluder. In use, the occluder being actuatable to alternate between the occluded configuration, in which pumped fluid accumulates in the vascular system becoming increasingly under pressure via elastic deformation of vessels, and the flow configuration, in which accumulated pumped fluid under pressure flows past the occluder at a greater pressure than the fluid pump outlet pressure, returning the elastically deformed vessels towards their original state.

Claims

1-91. (canceled)

92. An assist system for assisting blood flow in a vascular system, the assist system comprising: an implantable pump having a fluid inlet and a fluid outlet, each of the fluid inlet and the fluid outlet configured for being in fluid communication with the vascular system; an occluder element configured for being implanted in the vascular system downstream of the fluid outlet of the implantable pump, the occluder element having an occluded configuration in which the occluder element occludes the vascular system so that blood flowing downstream in the vascular system from the fluid outlet of the implantable pump toward the occluder element is at least partially blocked from flowing further downstream past the occluder element, and the occluder element having a flow configuration in which blood flowing downstream in the vascular system from the fluid outlet of the implantable pump toward the occluder element is capable of flowing further downstream past the occluder element; and an actuator element operatively connected to the occluder element for actuating the occluder element between the occluded configuration and the flow configuration.

93. The assist system according to claim 92, wherein the implantable pump, the occluder element, and the actuator element together form a unitary structure.

94. The assist system according to claim 93, wherein the unitary structure is an implantable unitary structure in which the actuator element comprises an end portion configured for connecting to an extracorporeal controller for actuating the occluder element between the occluded configuration and the flow configuration.

95. The assist system according to claim 92, wherein the implantable pump is an intravascular pump.

96. The assist system according to claim 95, wherein the intravascular pump comprises an anchor configured for anchoring the intravascular pump within the vascular system.

97. The assist system according to claim 92, wherein the occluder element comprises a cage configured for anchoring the assist system within the vascular system.

98. The assist system according to claim 97, wherein the cage is overcomeably biased toward the occluded configuration.

99. The assist system according to claim 92, wherein the occluder element comprises a cage and an occlusion film connected to the cage, and the actuator element comprises a control wire operatively connected to the cage for actuating the occluder element between the occluded configuration and the flow configuration.

100. The assist system according to claim 99, wherein the occlusion film is connected to a proximal end portion of the cage.

101. The assist system according to claim 99, wherein the occlusion film is connected to a distal end portion of the cage.

102. The assist system according to claim 92, wherein the occluder element comprises a cage and an occlusion film connected to the cage, the occlusion film forming a valve, and the actuator element comprises a control wire and a valve actuating element connected to the control wire, the valve actuating element configured for actuating the valve between the occluded configuration and the flow configuration.

103. The assist system according to claim 102, wherein the valve is a leaflet valve that is at least partially disposed within the cage.

104. The assist system according to claim 92, wherein the occluder element comprises a cage and a butterfly valve pivotably connected to the cage, and the actuator element comprises a control wire operatively connected to the butterfly valve for actuating the butterfly valve between the occluded configuration and the flow configuration.

105. The assist system according to claim 92, wherein the occluder element comprises a balloon.

106. The assist system according to claim 92, wherein the occluder element comprises a first occluder operatively connected to the actuator element for actuating the first occluder between the occluded configuration and the flow configuration, and a second occluder operatively connected to the actuator element for actuating the second occluder between the occluded configuration and the flow configuration.

107. The assist system according to claim 106, wherein the first occluder and the second occluder are actuatable in the flow configuration independently.

108. The assist system according to claim 106, wherein the first occluder and the second occluder are actuatable in the flow configuration simultaneously.

109. The assist system according to claim 106, wherein the first occluder and the second occluder are actuatable in the flow configuration sequentially.

110. The assist system according to claim 106, wherein the actuator element comprises a first actuator operatively connected to the first occluder for actuating the first occluder between the occluded configuration and the flow configuration, and a second actuator operatively connected to the second occluder for actuating the second occluder between the occluded configuration and the flow configuration.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0104] For a better understanding of the present technology, as well as other aspects and further features thereof, reference is made to the following description which is to be used in conjunction with the accompanying drawings, where:

[0105] FIG. 1 illustrates a schematic view of the human cardiovascular anatomy being a first implementation of the present technology where an occluder is positioned in the ascending aorta to increase coronary perfusion.

[0106] FIG. 2 illustrates a schematic view of the human cardiovascular anatomy being a second implementation of the present technology where an occluder is positioned in the proximal descending aorta to increase carotid artery and coronary perfusion.

[0107] FIG. 3 illustrates a schematic view of the human cardiovascular anatomy being a third implementation of the present technology where an occluder is positioned in the descending aorta in a supra-renal position to increase visceral artery perfusion.

[0108] FIG. 4 illustrates a schematic view of the human cardiovascular anatomy being a fourth implementation of the present technology where an occluder is positioned in the descending aorta in an infra-renal position to increase kidney perfusion.

[0109] FIG. 5 illustrates a schematic view of the human cardiovascular anatomy being a fifth implementation of the present technology where occluders are positioned in the axillary and iliac arteries bilaterally to increase carotid and visceral artery perfusion.

[0110] FIG. 6 illustrates a schematic view of the human cardiovascular anatomy being a sixth implementation of the present technology where an intra-aortic pump is positioned above the renal arteries and an occluder is positioned below the renal arteries to increase renal artery perfusion pressures or pulse pressures.

[0111] FIG. 7 illustrates a schematic view of the human cardiovascular anatomy being a seventh implementation of the present technology where an intra-aortic pump is positioned above the coeliac trunk and an occluder is positioned below the superior mesenteric artery to increase splanchnic artery perfusion pressures or pulse pressures.

[0112] FIG. 8 illustrates a schematic view of the human cardiovascular anatomy being an eight implementation of the present technology wherein an intra-caval pump is positioned in the inferior vena cava and an occluder is positioned in the superior vena cava to increase right heart filling.

[0113] FIGS. 9A-9G show a first embodiment of an occluder of the present technology. This first embodiment has two sub-embodiments. FIG. 9A is an isometric view of the device taken from a distal point of view when closed (e.g., in a flow configuration) (first sub-embodiment). FIG. 9B is a plan view of the device when closed (e.g., in a flow configuration) (first sub-embodiment). FIG. 9C is a plan view of the device when opened (e.g., in an occluded configuration) (second sub-embodiment). FIG. 9D is close up plan view of the device as shown in FIG. 9C (second sub-embodiment). FIG. 9E is an isometric view of the device when opened taken from a distal point of view (e.g., in an occluded configuration) (first-sub embodiment). FIG. 9F is a plan view of the device taken from an opposite side to that shown in FIGS. 9C and 9D (first sub-embodiment). FIG. 9G is an isometric view of the device when opened taken from a proximal point of view (e.g., in an occluded configuration) (first-sub embodiment).

[0114] FIGS. 10A-F show a second embodiment of an occluder of the present technology. FIG. 10A is an isometric view of the device taken from a distal point of view when in a closed configuration (e.g., in an occluded configuration). FIG. 10B is a plan view of the device when in a closed configuration (e.g., in an occluded configuration). FIG. 10C is an isometric view of the device taken from a distal point of view when in an opened configuration (e.g., in a flow configuration). FIG. 10D is a plan view of the device when in an opened configuration (e.g., in a flow configuration). FIG. 10E is an isometric view of the device taken from a proximal point of view when in a closed configuration (e.g., in an occluded configuration). FIG. 10F is an isometric view of the device taken from a proximal point of view when in an opened configuration (e.g., in a flow configuration).

[0115] FIGS. 11A-11H show a third embodiment of an occluder of the present technology. FIG. 11A is an isometric view of the device taken from a distal point of view when in a closed configuration (e.g., in an occluded configuration). FIG. 11B is a plan view of the device when in a closed configuration (e.g., in an occluded configuration). FIG. 11C is an isometric view of the device taken from a distal point of view when in an opened configuration (e.g., in a flow configuration). FIG. 11D is a plan view of the device when in an opened configuration (e.g., in a flow configuration.). FIG. 11E is a first close-up view of the valve of the device taken from a distal point of view when the device is in a closed configuration (e.g., in an occluded configuration). FIG. 11F is a second close-up view of the valve of the device when the device is in a closed configuration (e.g., in an occluded configuration), showing the pivoting mechanism. FIG. 11G is an isometric view of the device taken from a proximal point of view when in a closed configuration (e.g., in an occluded configuration). FIG. 11H is an isometric view of the device taken from a proximal point of view when in an opened configuration (e.g., in a flow configuration).

DETAILED DESCRIPTION OF SOME EMBODIMENTS

[0116] In the figures there are shown various schematics of the human cardiovascular system in which systems of the present technology have been implemented. It is to be expressly understood that the various schematics are merely some implementations of the present technology. Thus, the description thereof that follows is intended to be only a description of illustrative examples of the present technology. This description is not intended to define the scope or set forth the bounds of the present technology. In some cases, what are believed to be helpful examples of modifications these schematics may also be set forth below. This is done merely as an aid to understanding, and, again, not to define the scope or set forth the bounds of the present technology. These modifications are not an exhaustive list, and, as a person skilled in the art would understand, other modifications are likely possible. Further, where this has not been done (i.e., where no examples of modifications have been set forth), it should not be interpreted that no modifications are possible and/or that what is described is the sole manner of implementing that element of the present technology. As a person skilled in the art would understand, this is likely not the case. In addition, it is to be understood that the schematics may provide in certain instances simple implementations of the present technology, and that where such is the case they have been presented in this manner as an aid to understanding. As persons skilled in the art would understand, various implementations of the present technology may be of a greater complexity. Finally, being “schematics”, the figures showing schematics are not intended to show in complete detail either the implementations of the present technology or the human cardiovascular system. They are intended to be representations only, addressed to persons of skill in the art.

Description of Relevant Human Cardiovascular Anatomy

[0117] In FIGS. 1 to 7, the following parts of the human cardiovascular anatomy are shown and referenced: right axillary artery 80, carotid arteries 81, left axillary artery 82, coeliac trunk 83, superior mesenteric artery 84, left renal artery 85, inferior mesenteric artery 86, left common iliac artery 87, right common iliac artery 88, and the right renal artery 89.

[0118] In FIG. 8, the following parts of the human cardiovascular anatomy are shown and referenced: left renal vein 90, right renal vein 92, inferior vena cava 94, right auricle 96 (of heart 50), and superior vena cava 98.

First Implementation

[0119] Referring to FIG. 1, there is a shown a first implementation of the present technology 100. In this implementation there is a single fluid pump 102, being a conventional left ventricle assist device (LVAD) (an “apical pump”), which has been surgically implanted using conventional techniques. The LVAD 102 has a blood flow inlet 104 surgically fluidly connected to the left ventricle 52 of the heart 50. The left auricle 54 of the heart 50 is also shown in FIG. 1. The LVAD 102 has a blood flow outlet 106 surgically fluidly connected to the ascending aorta 56. A single occluder 108 (the structure of which is discussed hereinbelow) has been surgically transcatheterly implanted in the ascending aorta 56. (Transcatheter implantations generally are described in the WO '765 Publication.)

[0120] In use, the LVAD 102 is conventionally operated. Blood enters the LVAD 102 via the inlet 104 and is discharged from the LVAD 102 via the outlet 106 (at a blood outlet pressure). The occluder 108 alternates between an occluded configuration (in which blood cannot pass the occluder 108 and travel in the vascular system 58 downstream from the occluder 108) and flow configuration (in which blood can pass the occluder 108 and travel in the vascular system 58 downstream from the occluder 108). When the occluder 108 is in the occluded configuration, pumped blood being discharged by the LVAD 102 will accumulate upstream of the occluder 108, increasing coronary perfusion. The pressure of the discharged pumped blood will also increase beyond the LVAD blood outlet pressure, via elastic deformation of the coronary vasculature. When the occluder 108 is in the flow configuration, accumulated pump blood will pass the occluder 108 at this higher pressure. The elastically deformed coronary vasculature will return towards is normal state. In this way the systolic/diastolic cycle of the heart may be simulated. (Not shown in the figure are the controller, the actuator, power source and wiring.)

Second Implementation

[0121] Referring to FIG. 2, there is a shown a second implementation of the present technology 200. In this implementation there is a single fluid pump 202, being a conventional left ventricle assist device (LVAD) (an “apical pump”), which has been surgically implanted using conventional techniques. The LVAD 202 has a blood flow inlet 204 surgically fluidly connected to the left ventricle 52 of the heart 50. The left auricle 54 of the heart 50 is also shown in FIG. 2. The LVAD 202 has a blood flow outlet 206 surgically fluidly connected to the ascending aorta 56. A single occluder 208 (the structure of which is discussed hereinbelow) has been surgically transcatheterly implanted in the proximal descending aorta 60.

[0122] In use, the LVAD 202 is conventionally operated. Blood enters the LVAD 202 via the inlet 204 and is discharged from the LVAD 202 via the outlet 206 (at a blood outlet pressure). The occluder 208 alternates between an occluded configuration (in which blood cannot pass the occluder 208 and travel in the vascular system 58 downstream from the occluder 208) and flow configuration (in which blood can pass the occluder 208 and travel in the vascular system 58 downstream from the occluder 208). When the occluder 208 is in the occluded configuration, pumped blood being discharged by the LVAD 202 will accumulate upstream of the occluder 208, increasing carotid artery and coronary perfusion. The pressure of the discharged pumped blood will also increase beyond the LVAD blood outlet pressure, via elastic deformation of the portions of the vascular system 58 fluidly between the outlet 206 and the occluder 208. When the occluder 208 is in the flow configuration, accumulated pump blood will pass the occluder 208 at this higher pressure. The elastically deformed portions of the vasculature will return towards their normal state. In this way the systolic/diastolic cycle of the heart may be simulated. (Not shown in the figure are the controller, the actuator, power source and wiring.)

Third Implementation

[0123] Referring to FIG. 3, there is a shown a third implementation of the present technology 300. In this implementation there is a single fluid pump 302, being a conventional left ventricle assist device (LVAD) (an “apical pump”), which has been surgically implanted using conventional techniques. The LVAD 302 has a blood flow inlet 304 surgically fluidly connected to the left ventricle 52 of the heart 50. The left auricle 54 of the heart 50 is also shown in FIG. 3. The LVAD 302 has a blood flow outlet 306 surgically fluidly connected to the ascending aorta 56. A single occluder 308 (the structure of which is discussed hereinbelow) has been surgically transcatheterly implanted in the descending aorta in a supra-renal position 62.

[0124] In use, the LVAD 302 is conventionally operated. Blood enters the LVAD 302 via the inlet 304 and is discharged from the LVAD 302 via the outlet 306 (at a blood outlet pressure). The occluder 308 alternates between an occluded configuration (in which blood cannot pass the occluder 308 and travel in the vascular system 58 downstream from the occluder 308) and flow configuration (in which blood can pass the occluder 308 and travel in the vascular system 58 downstream from the occluder 308). When the occluder 308 is in the occluded configuration, pumped blood being discharged by the LVAD 302 will accumulate upstream of the occluder 308, increasing visceral artery, carotid artery and coronary perfusion. The pressure of the discharged pumped blood will also increase beyond the LVAD blood outlet pressure, via elastic deformation of the portions of the vascular system 58 fluidly between the outlet 306 and the occluder 308. When the occluder 308 is in the flow configuration, accumulated pump blood will pass the occluder 308 at this higher pressure. The elastically deformed portions of the vasculature will return towards their normal state. In this way the systolic/diastolic cycle of the heart may be simulated. (Not shown in the figure are the controller, the actuator, power source and wiring.)

Fourth Implementation

[0125] Referring to FIG. 4, there is a shown a fourth implementation of the present technology 400. In this implementation there is a single fluid pump 402, being a conventional left ventricle assist device (LVAD) (an “apical pump”), which has been surgically implanted using conventional techniques. The LVAD 402 has a blood flow inlet 404 surgically fluidly connected to the left ventricle 52 of the heart 50. The left auricle 54 of the heart 50 is also shown in FIG. 4. The LVAD 402 has a blood flow outlet 406 surgically fluidly connected to the ascending aorta 56. A single occluder 408 (the structure of which is discussed hereinbelow) has been surgically transcatheterly implanted in the descending aorta in an infra-renal position 64.

[0126] In use, the LVAD 402 is conventionally operated. Blood enters the LVAD 402 via the inlet 404 and is discharged from the LVAD 402 via the outlet 406 (at a blood outlet pressure). The occluder 408 alternates between an occluded configuration (in which blood cannot pass the occluder 408 and travel in the vascular system 58 downstream from the occluder 408) and flow configuration (in which blood can pass the occluder 408 and travel in the vascular system 58 downstream from the occluder 408). When the occluder 408 is in the occluded configuration, pumped blood being discharged by the LVAD 402 will accumulate upstream of the occluder 408, increasing kidney perfusion. The pressure of the discharged pumped blood will also increase beyond the LVAD blood outlet pressure, via elastic deformation of the portions of the vascular system 58 fluidly between the outlet 406 and the occluder 408. When the occluder 408 is in the flow configuration, accumulated pump blood will pass the occluder 408 at this higher pressure. The elastically deformed portions of the vasculature will return towards their normal state. In this way the systolic/diastolic cycle of the heart may be simulated. (Not shown in the figure are the controller, the actuator, power source and wiring.)

Fifth Implementation

[0127] Referring to FIG. 5, there is a shown a fifth implementation of the present technology 500. In this implementation there is a single fluid pump 502, being a conventional left ventricle assist device (LVAD) (an “apical pump”), which has been surgically implanted using conventional techniques. The LVAD 402 has a blood flow inlet 504 surgically fluidly connected to the left ventricle 52 of the heart 50. The left auricle 54 of the heart 50 is also shown in FIG. 5. The LVAD 502 has a blood flow outlet 506 surgically fluidly connected to the ascending aorta 56. In this implementation, multiple occluders 508, 510, 512, 514 (the structure of which is discussed hereinbelow) have been surgically transcatheterly implanted in the vascular system 58. A first occluder 508 has been positioned in the right axillary artery 66. A second occluder 510 has been positioned in the left axillary artery 68. A third occluder 512 has been positioned in the right common iliac artery 70. A fourth occluder 514 has been positioned in the left common iliac artery 72.

[0128] In use, the LVAD 502 is conventionally operated. Blood enters the LVAD 502 via the inlet 504 and is discharged from the LVAD 502 via the outlet 506 (at a blood outlet pressure). The occluders 508, 510, 512, 514 can alternate between an occluded configuration (in which blood cannot pass an occluder 508, 510, 512, 514 and travel in the vascular system 58 downstream from that occluder 508, 510, 512, 514) and flow configuration (in which blood can pass an occluder 508, 510, 512, 514 and travel in the vascular system 58 downstream from that occluder 508, 510, 512, 514). When all of the occluders 508, 510, 512, 514 are in the occluded configuration, pumped blood being discharged by the LVAD 402 will accumulate upstream of the occluders 508, 510, 512, 514 increasing carotid and visceral artery perfusion. The pressure of the discharged pumped blood will also increase beyond the LVAD blood outlet pressure, via elastic deformation of the portions of the vascular system 58 fluidly between the outlet 406 and the occluders 508, 510, 512, 514. When an occluder 508, 510, 512, 514 is in the flow configuration, accumulated pump blood will pass that occluder 508, 510, 512, 514 at this higher pressure. The elastically deformed portions of the vasculature will return towards their normal state. In this way the systolic/diastolic cycle of the heart may be simulated. It should be noted that all of the occluders 508, 510, 512, 514 can be in the flow configuration simultaneously; more than one but less than all of the occluders 508, 510, 512, 514 can be in the flow configuration simultaneously; or only one of the occluders 508, 510, 512, 514 can be in the flow configuration at a time. No particular sequence of occluder (or devices) 508, 510, 512, 514 being the flow configuration is required in the context of the present technology. All potential sequences are possible, depending on the intended purpose of the system.

Sixth Implementation

[0129] Referring to FIG. 6, there is a shown a sixth implementation of the present technology 600. In this implementation there is a single intra-aortic fluid pump 602, being of the type described in the WO '765 application. The intra-aortic fluid pump 602 has been surgically transcatheterly implanted in the descending aorta in a supra-renal position, as described in the WO '765 Publication. The intra-aortic fluid pump 602 has an upstream blood flow inlet 604 within the descending aorta and a downstream blood flow outlet 606 also within the descending aorta. The left ventricle 52 and auricle 54 of the heart 50 are also shown in FIG. 6.

[0130] A single occluder 608 (the structure of which is discussed hereinbelow) has been surgically transcatheterly implanted in the descending aorta in an infra-renal position 64.

[0131] In use, the intra-aortic fluid pump 602 is operated as described in the WO '765 Publication. Blood enters the intra-aortic fluid pump 602 via the inlet 604 and is discharged from the intra-aortic fluid pump 602 via the outlet 606 (at a blood outlet pressure). The occluder 608 alternates between an occluded configuration (in which blood cannot pass the occluder 608 and travel in the vascular system 58 downstream from the occluder 608) and flow configuration (in which blood can pass the occluder 608 and travel in the vascular system 58 downstream from the occluder 608). When the occluder 608 is in the occluded configuration, pumped blood being discharged by the intra-aortic fluid pump 602 will accumulate upstream of the occluder 608, increasing renal artery perfusion pressures or pulse pressures. The pressure of the discharged pumped blood will also increase beyond the intra-aortic fluid pump 602 blood outlet pressure, via elastic deformation of the portions of the vascular system 58 fluidly between the outlet 606 and the occluder 608. When the occluder 608 is in the flow configuration, accumulated pump blood will pass the occluder 608 at this higher pressure. The elastically deformed portions of the vasculature will return towards their normal state. In this way the systolic/diastolic cycle of the heart may be simulated. (Not shown in the figure are the controller, the actuator, power source and wiring.)

Seventh Implementation

[0132] Referring to FIG. 7, there is a shown a seventh implementation of the present technology 700. In this implementation there is a single intra-aortic fluid pump 702, being of the type described in the WO '765 Publication. The intra-aortic fluid pump 702 has been surgically transcatheterly implanted in the descending aorta in a position 74 above the coeliac trunk as described in the WO '765 Publication. The intra-aortic fluid pump 702 has an upstream blood flow inlet 704 within the descending aorta and a downstream blood flow outlet 706 also within the descending aorta. The left ventricle 52 and auricle 54 of the heart 50 are also shown in FIG. 7.

[0133] A single occluder 708 (the structure of which is discussed hereinbelow) has been surgically transcatheterly implanted in the descending aorta below in a position the superior mesenteric artery.

[0134] In use, the intra-aortic fluid pump 702 is operated as described in the WO '765 Publication. Blood enters the intra-aortic fluid pump 702 via the inlet 704 and is discharged from the intra-aortic fluid pump 702 via the outlet 706 (at a blood outlet pressure). The occluder 708 alternates between an occluded configuration (in which blood cannot pass the occluder 708 and travel in the vascular system 58 downstream from the occluder 708) and flow configuration (in which blood can pass the occluder 708 and travel in the vascular system 58 downstream from the occluder 708). When the occluder 708 is in the occluded configuration, pumped blood being discharged by the intra-aortic fluid pump 702 will accumulate upstream of the occluder 708, increasing splanchnic artery perfusion pressures or pulse pressures. The pressure of the discharged pumped blood will also increase beyond the intra-aortic fluid pump 702 blood outlet pressure, via elastic deformation of the portions of the vascular system 58 fluidly between the outlet 706 and the occluder 708. When the occluder 708 is in the flow configuration, accumulated pump blood will pass the occluder 708 at this higher pressure. The elastically deformed portions of the vasculature will return towards their normal state. In this way the systolic / diastolic cycle of the heart may be simulated. (Not shown in the figure are the controller, the actuator, power source and wiring.)

Eighth Implementation

[0135] Referring to FIG. 8, there is a shown an eighth implementation of the present technology 800. In this implementation there is a single intra-caval fluid pump 802, being of the type described in the WO '765 Publication. The intra-caval fluid pump 802 has been surgically implanted in the inferior vena cava in a position 76 above the renal veins as described in the WO '765 Publication. The intra-caval fluid pump 802 has an upstream blood flow inlet 804 within the inferior vena cava and a downstream blood flow outlet 806 also within the inferior vena cava. The heart 50 is also shown in FIG. 8.

[0136] A single occluder 808 (the structure of which is discussed hereinbelow) has been surgically transcatheterly implanted in the superior vena cava in a position 78.

[0137] In use, the intra-caval fluid pump 802 is operated as described in the WO '765 Publication. Blood enters the intra-caval fluid pump 802 via the inlet 804 and is discharged from the intra-caval fluid pump 802 via the outlet 806 (at a blood outlet pressure). The occluder 808 alternates between an occluded configuration (in which blood cannot pass the occluder 808 and travel in the vascular system 58 downstream from the occluder 808) and flow configuration (in which blood can pass the occluder 808 and travel in the vascular system 58 downstream from the occluder 808). When the occluder 808 is in the occluded configuration, pumped blood being discharged by the intra-caval fluid pump 802 will accumulate upstream of the occluder 808, increasing right heart filling. (Not shown in the figure are the controller, the actuator, power source and wiring.)

Occluder—First Embodiment

[0138] Referring to FIGS. 9A-9G, there is shown a first embodiment of an occluder 1100 of the present technology. As shown in the figures, the device 1100 has two configurations, a closed (flow) configuration and an open (occluded) configuration. The device 1100 is shaped and dimensioned to be implanted within the vascular system of a human body transcatheterly (transcatheter implantations are described in the WO '765 Publication). When the device 1100 is implanted within the vascular system of the human body, and in the closed configuration, the device 1100 is in a flow configuration in which it will allow blood to pass by the device 1100 from upstream of the device 1100 to downstream of the device 1100. When the device 1100 is implanted within the vascular system of the human body at a particular location, the device is dimensioned and shaped such that in the opened configuration the device 1100 is in an occluded configuration. When in the occluded configuration the device 1100 will block blood from passing by the device 1100 from upstream of the device 1100 to downstream of the device 1100.

[0139] The device 1100 has an external sheath 1102, an internal guide 1104, an expandable/collapsible cage 1106, an occlusion film 1108, and a control wire 1110. The external sheath 1102 is formed by a catheter. The internal guide 1104 is an elongated tubular structure within the lumen of the external sheath 1102. Within the lumen of the internal guide 1104 is the control wire 1110. Attached to the distal end of the internal guide 1104 is the proximal end of the cage 1106. The cage 1106 is formed of nitinol (a shape-retaining memory alloy). Attached to the distal end of the cage is the control wire 1110. The occlusion film 1108 is connected to the wires 1112 forming the cage 1106. The occlusion film 1108 is made of polytetrafluoroethylene (PTFE), but may be made of any appropriate biocompatible material (e.g., polyester).

[0140] In operation, in the closed (flow) configuration the wires 1112 of the cage 1106 are restrained within the external sheath 1102. As the cage 1106 exits the external sheath 1102, the wires 1112 assume their shape, causing the cage 1106 to expand. The cage 1106 will expand to the point where the wires 1112 contact the wall of the blood vessel in which the cage 1106 has been implanted. This will serve to anchor the cage 1106 to the wall. As the cage 1106 has expanded it has extended the occlusion film 1108 that is attached to the wires 1112 of the cage 1106. The occlusion film 1108 is sized and shaped such that it will block the entire lumen of the blood vessel, preventing passage of blood through the blood vessel at that point. At this point the device 1100 is in the open (occluded) configuration. (The process can be analogized to the opening of an umbrella.). Pulling the control wire 1110 will reverse the process, collapsing the cage 1106, returning the device 1100 to the closed (flow) configuration, and allowing blood to once again pass by the device 1100 and flow downstream thereof. (This process can analogized to the closing of an umbrella.)

[0141] In this first embodiment there are two sub-embodiments, the first being shown in FIGS. 9A, 9B, 9E, 9F and 9G, while the second is shown in FIGS. 9C and 9D. The difference between these two sub-embodiments is the location of the occlusion film 1108. In the first sub-embodiment, the occlusion film 1108 is positioned at the distal end of the cage 1106 (thus the blood flow would be occluded by the “topside of the umbrella”). In the second sub-embodiment, the occlusion film is positioned at the proximal end of the cage 1108 (thus the blood flow would be occluded by the “underside of the umbrella”).

[0142] The control wire is attached to a conventional electromechanical actuation system (not shown, but inside sheath 1102) that includes a conventional microcontroller, a conventional rechargeable battery, and a conventional motor (e.g., a solenoid, a camshaft motor, etc.). Examples of such conventional components are provided in the following documents, the entirety of each of which is incorporated herein by reference: [0143] International Patent Application Publication No. WO 2019/183247 A1, published Sep. 26, 2019, entitled “Circulatory Assist Pump” (Second Heart Assist, Inc.) [0144] International Patent Application Publication No. WO 2019/083989 A1, published May 2, 2019, entitled “Systems and Methods for Selectively Occluded the Superior Vena Cava for Treating Heart Conditions” (Tufts Medical Center, Inc.) [0145] International Patent Application Publication No. WO 2015/109028 A1, published Jul. 23, 2015, entitled “Apparatus and Methods for Optimizing Intra Cardiac Filling Pressures, Heart Rate, and Cardiac Output” (Kaiser et al.) [0146] International Patent Application Publication No. WO 2014/070472 A1, published May 8, 2014, entitled “Leadless Pacemaker System” (Medtronic, Inc.) [0147] International Patent Application Publication No. WO 2012/094641 A2, published Jul. 12, 2012, entitled “Percutaneous Heart Pump” (Thoratec Corp. et al.) [0148] U.S. Patent Application Publication No. US 2020/0261633 A1, published Aug. 20, 2020, entitled “Intravascular Blood Pump” (ABIOMED EUROPE GmbH) [0149] U.S. Patent Application Publication No. US 2019/0126014 A1, published May 2, 2019, entitled “Systems and Methods for Selectively Occluded the Superior Vena Cava for Treating Heart Conditions” (Kapur et al.) [0150] U.S. Patent Application Publication No. US 2009/0247945 A1, published Oct. 1, 2009, entitled “Balloons and Balloon Catheter Systems for Treating Vascular Occlusions” (Levit et al.) [0151] U.S. Pat. No. 9,808,633 B2, granted Nov. 7, 2017, entitled “Leadless Pacemaker System” (Bonner et al.) [0152] U.S. Pat. No. 9,375,580 B2, granted Jun. 28, 2016, entitled “Leadless Pacemaker System” (Bonner et al.) [0153] U.S. Pat. No. 9,216,298 B2, granted Dec. 22, 2015, entitled “Leadless Cardiac Pacemaker System with Conductive Communication” (Jacobson)

[0154] The control wire can also be operated manually (if so appropriate) via a conventional mechanical actuation system. See for example. U.S. Pat. No. 10,279,094 B2, grated May 7, 2019, entitled “Endovascular Variable Aortic Control Catheter” (Williams et al.), which is incorporated herein by reference in its entirety.

Occluder—Second Embodiment

[0155] Referring to FIGS. 10A-10F, there is shown a second embodiment of an occluder 1200 of the present technology. As shown in the figures, the device 1200 has two operational configurations, a closed configuration and an open configuration. The device 1200 is shaped and dimensioned to be implanted within the vascular system of a human body transcatheterly. When the device 1200 is implanted within the vascular system of the human body, and in the open configuration, the device 1200 is in a flow configuration in which it will allow blood to passing by the device 1200 from upstream of the device 1200 to downstream of the device 1200. When the device 1200 is implanted within the vascular system of the human body at a particular location, the device is dimensioned and shaped such that in the closed configuration the device 1200 is in an occluded configuration. When in the occluded configuration the device 1200 will block blood from passing by the device 1200 from upstream of the device 1200 to downstream of the device 1200.

[0156] The device 1200 has an external sheath 1202, an internal guide 1204, an expandable/collapsible cage 1206, an occlusion film 1208, and a control wire 1210. The external sheath 1202 is formed by a catheter. The internal guide 1204 is an elongated tubular structure within the lumen of the external sheath 1202. Within the lumen of the internal guide 1204 is the control wire 1210. Attached to the distal end of the internal guide 1204 is the proximal end of the cage 1206. The cage 1206 is formed of nitinol (a shape-retaining memory alloy). Attached to the distal end the control wire 1210 is valve actuating element 1214. The occlusion film 1208 is connected to the wires 1212 forming the cage 1206 at the distal end of the cage. In this embodiment, the occlusion film 1208 forms a leaflet valve, which is actuated by the valve actuating element 1214. In this embodiment the occlusion film 1208 is polytetrafluoroethylene.

[0157] In operation, in the delivery configuration the wires 1212 of the cage 1206 are restrained within the external sheath 1202. On implantation, as the cage 1206 exits the external sheath 1202, the wires 1212 assume their shape, causing the cage 1206 to expand. The cage 1206 will expand to the point where the wires 1212 contact the wall of the blood vessel in which the cage 1206 has been implanted. This will serve to anchor the cage 1206 to the wall. As the cage 1206 has expanded it has extended the occlusion film 1208 that is attached to the wires 1212 of the cage 1206. The occlusion film 1208 is sized and shaped such that it will form a leaflet valve when unfurled. When the valve is closed, the film 1208 can block the entire lumen of the blood vessel, preventing passage of blood through the blood vessel at that point. At this point the device 1200 is in the closed (occluded) configuration. When the valve is open, the film 1208 will not block the entire lumen of the blood vessel, allowing blood to pass by the device 1200 and flow downstream thereof. At this point the device is in the open (flow) configuration.

[0158] Moving the control wire 1210 positions the valve actuating element 1214 so as to open or close the valve formed by the film 1208. The control wire 1210 may be moved by any conventional system as described hereinabove with respect to the first embodiment.

Occluder—Third Embodiment

[0159] Referring to FIGS. 11A-11H, there is shown a third embodiment of an occluder 1300 of the present technology. As shown in the figures, the device 1300 has two operational configurations, a closed configuration and an open configuration. The device 1300 is shaped and dimensioned to be implanted within the vascular system of a human body transcatheterly. When the device 1300 is implanted within the vascular system of the human body, and in the open configuration, the device 1300 is in a flow configuration in which it will allow blood to passing by the device 1300 from upstream of the device 1300 to downstream of the device 1300. When the device 1300 is implanted within the vascular system of the human body at a particular location, the device is dimensioned and shaped such that in the closed configuration the device 1300 is in an occluded configuration. When in the occluded configuration the device 1300 will block blood from passing by the device 1300 from upstream of the device 1300 to downstream of the device 1300.

[0160] The device 1300 has an external sheath 1302, an internal guide 1304, an expandable/collapsible cage 1306, an occluding element 1316, and a control wire 1310. The external sheath 1302 is formed by a catheter. The internal guide 1304 is an elongated tubular structure within the lumen of the external sheath 1302. Within the lumen of the internal guide 1304 is the control wire 1310. Attached to the distal end of the internal guide 1304 is the proximal end of the cage 1306. The cage 1306 is formed of nitinol (a shape-retaining memory alloy). The occluding element 1316 is attached to the distal end the control wire 1310. The occluding element 1316 is connected to the wires 1312 forming the cage 1306 via a pivoting element 1318. In this embodiment, the occluding element 1316 forms a butterfly valve, which is actuated (to pivot) by the control wire 1310. The occluding element 1316 and the pivoting element 1318 are made of nitinol.

[0161] In operation, in the delivery configuration the wires 1312 of the cage 1306 are restrained within the external sheath 1306. On implantation, as the cage 1306 exits the external sheath 1306, the wires 1312 assume their shape, causing the cage 1306 to expand. The cage 1306 will expand to the point where the wires 1312 contact the wall of the blood vessel in which the cage 1306 has been implanted. This will serve to anchor the cage 1306 to the wall. As the cage 1306 has allowed the occluded element 1316 to expand as well. The occluded element 1316 is sized and shaped and attached to the pivoting element 1318, which itself is pivotably attached to the cage 1306 (at pivot point 1320, see e.g., FIG. 11F) such that it will form a butterfly valve when expanded. When the valve is closed, the element 1316 can block the entire lumen of the blood vessel, preventing passage of blood through the blood vessel at that point. At this point the device 1300 is in the closed (occluded) configuration. When the valve is open, the element 1308 will not block the entire lumen of the blood vessel, allowing blood to pass by the device 1300 and flow downstream thereof. At this point the device is in the open (flow) configuration.

[0162] Moving the control wire 1310 pivots element 1316 so as to open or close the valve formed by the element 1316. The control wire 1210 may be moved by any conventional system as described hereinabove with respect to the first embodiment.

Miscellaneous

[0163] The present technology is not limited in its application to the details of construction and the arrangement of components set forth in the previous description or illustrated in the drawings. The disclosure is capable of other embodiments, implementations and of being practiced or of being carried out in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including”, “comprising”, or “having”, “containing”, “involving” and variations thereof herein, is meant to encompass the items listed thereafter as well as, optionally, additional items. In the previous description, the same numerical references refer to similar elements.

[0164] It must be noted that, as used in this specification and the appended claims, the singular form “a”, “an” and “the” include plural referents unless the context clearly dictates otherwise.

[0165] As used herein, the term “about” in the context of a given value or range refers to a value or range that is within 20%, preferably within 10%, and more preferably within 5% of the given value or range.

[0166] As used herein, the term “and/or” is to be taken as specific disclosure of each of the two 10 specified features or components with or without the other. For example, “A and/or B” is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0167] Modifications and improvements to the above-described implementations of the present technology may become apparent to those skilled in the art. The foregoing description is intended to be exemplary rather than limiting. The scope of the present technology is therefore intended to be limited solely by the scope of the appended claims.