Intra-aortic chamber for cardiac assistance

Abstract

The invention discloses system, devices and methods for generating pressure and generating an augmented downstream directional flow in a patient's blood vessel. For example, the device comprises a conduit being substantially sealed configured to pump blood from within said conduit by means of an inflatable element.

Description

[0001] INTRA-AORTIC CHAMBER FOR CARDIAC ASSISTANCE

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 660,583 filed on 17 June 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to a deployable intrabody pump and, more particularly, but not exclusively, to a deployable intrabody chamber configured to controllably drive blood.

[0006] Currently technologies to assist in increasing the blood flow in patients, like Intra- Aortic balloon pumps (IABP), Micro Axial Flow Pumps, ECMO or TandemHeart, do not provide a proper and / or adequate and / or safe solution. There is therefore a need to provide a system that is safe, effective, easy to use and incurs low (or none) hemolysis.

[0007] Additional background art includes U.S. Patent No. US 10137231B2 disclosing a circulatory assist apparatus comprising: an inflatable pumping balloon having a proximal end joined to an elongated balloon catheter, the balloon catheter having a distal end joined to the pumping balloon and a proximal end, separated from the distal end by a length sufficient to extend from within a circulatory lumen to the outside of a patient's body, for receiving positive and negative pressure pulses from a pump to inflate and deflate the pumping balloon; and a radially expandable frame, mounted on one of a segment extending distally from the pumping balloon, the balloon catheter, and a sleeve tube surrounding the balloon catheter. The expandable frame is manipulated to expand within the circulatory lumen, and functions to space apart the inflatable balloon from the circulatory lumen, having a first diameter in a collapsed configuration for intraluminal delivery and a second, larger diameter in an expanded configuration achieved by said manipulation.

[0008] SUMMARY OF THE INVENTION

[0009] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below. Example 1. A device for increasing blood flow, comprising a conduit being substantially sealed configured to pump blood from within said conduit by means of an inflatable element.

[0010] Example 2. The device according to example 1, wherein said conduit comprises an expandable frame and a sleeve.

[0011] Example 3. The device according to Example 1 or claim 2, wherein said frame is covered by said sleeve.

[0012] Example 4. The device according to any one of examples 1-3, wherein said sleeve is embedded within said frame.

[0013] Example 5. The device according to any one of examples 1-4, wherein said conduit is completely sealed.

[0014] Example 6. The device according to any one of examples 1-5, wherein said conduit comprises a plurality of selectively opening perfusion flaps.

[0015] Example 7. The device according to any one of examples 1-6, wherein said device comprises a proximal valve positioned at a proximal end of said conduit.

[0016] Example 8. The device according to any one of examples 1-7, wherein said device comprises a distal valve positioned at a distal end of said conduit.

[0017] Example 9. The device according to any one of examples 1-8, wherein said inflatable element is a balloon.

[0018] Example 10. The device according to any one of examples 1-9, wherein said inflatable element is built-in within said conduit.

[0019] Example 11. The device according to any one of examples 1-10, wherein said inflatable element is insertable within said conduit after deployment of said conduit.

[0020] Example 12. The device according to any one of examples 1-11, wherein said inflatable element is configured to be translated within said conduit from a proximal position to a distal position and vice versa.

[0021] Example 13. The device according to any one of examples 1-12, wherein said inflatable element is configured to close an opening at a proximal end of said conduit.

[0022] Example 14. The device according to any one of examples 1-13, wherein said inflatable element is configured to close an opening at a distal end of said conduit.

[0023] Example 15. The device according to any one of examples 1-14, wherein said device comprises a compressed configuration and an expanded configuration; and wherein said device is delivered in said compressed configuration and actuated in said expanded configuration.

[0024] Example 16. The device according to any one of examples 1-15, wherein said frame comprises a plurality of struts configured to limit an expansion of said conduit to a predetermined size. Example 17. The device according to any one of examples 1-16, wherein said proximal valve comprises leaflets configured to open towards a single direction and wires configured to limit a movement of said leaflets to said single direction.

[0025] Example 18. The device according to any one of examples 1-17, wherein said distal valve comprises leaflets configured to open to a single direction and wires configured to limit a movement of said leaflets to said single direction.

[0026] Example 19. The device according to any one of examples 1-18, wherein said device comprises both a proximal valve and a distal valve.

[0027] Example 20. The device according to any one of examples 1-19, wherein said device is valveless. Example 21. The device according to any one of examples 1-20, further comprising a plurality of connectors connected on one side to a proximal end of said conduit and on another side to an elongated tube; said elongated tube extending proximally until exiting a body of said patient.

[0028] Example 22. The device according to any one of examples 1-21, wherein said device is deployed or retracted by actuation of said elongated tube.

[0029] Example 23. The device according to any one of examples 1-22, further comprising a plurality of redirection elements positioned on an external surface of said conduit.

[0030] Example 24. The device according to any one of examples 1-23, wherein said conduit comprises a length of from 3 cm to 35cm.

[0031] Example 25. The device according to any one of examples 1-24, wherein said device is configured to generate a flow from IL / Min to 8L / Min.

[0032] Example 26. The device according to any one of examples 1-25, wherein said device is configured to provide blood flow to side branches.

[0033] Example 27. The device according to any one of examples 1-26, further comprising one or more decentering elements externally attached to said conduit.

[0034] Example 28. The device according to any one of examples 1-27, further comprising at least one sensor configured to monitor at least one physiological parameter of a patient being treated with said device.

[0035] Example 29. The device according to any one of examples 1-28, wherein said at least one sensor is positioned in at least one location selected from group consisting of: on said device, within said patient but not on said device and externally of said patient.

[0036] Example 30. A method of treating a patient by generating pressure and generating an augmented downstream directional flow in a patient’s blood vessel, comprising: a. inserting a device for increasing blood flow into said blood vessel; said device comprising a conduit being substantially sealed configured to pump blood from within said conduit by means of an inflatable element; b. actuating said device to generate said augmented downstream directional flow from within said conduit.

[0037] Example 31. The method according to example 30, wherein said actuating comprises alternating between inflation and deflation of an inflatable element positioned within said device.

[0038] Example 32. The method according to example 30 or example 31, wherein said inserting comprises bringing a catheter to a location in said blood vessel and further comprises bringing said device in a compressed configuration to said location within said catheter.

[0039] Example 33. The method according to any one of examples 30-32, wherein said inserting comprises deploying said device in said blood vessel before said actuating.

[0040] Example 34. The method according to any one of examples 30-33, further comprising monitoring at least one physiological parameter of said patient.

[0041] Example 35. The method according to any one of examples 30-34, further comprising amending said actuating according to said monitored at least one physiological parameter.

[0042] Example 36. The method according to any one of examples 30-35, further comprising extracting said device at the end of said treating.

[0043] Example 37. A device for increasing blood flow, comprising: a. an expandable conduit, comprising an elongated body, a proximal end and a distal end; b. an inflatable element positioned within said conduit; c. a unidirectional distal valve, positioned at said distal end of said conduit and configured to allow flow of blood to an internal volume of said expandable conduit; d. a unidirectional proximal unidirectional valve, positioned at said proximal end of said conduit and configured to allow flow of blood from said internal volume outside of said expandable conduit; wherein said conduit is substantially sealed along said elongated body to permit passage of blood through said proximal end and / or said distal end.

[0044] Example 38. The device according to example 37, wherein said expandable conduit comprises a frame and a sleeve.

[0045] Example 39. The device according to example 37 or example 38, wherein said frame is covered by said sleeve.

[0046] Example 40. The device according to any one of examples 37-39, wherein said sleeve is embedded within said frame. Example 41. The device according to any one of examples 37-40, wherein said expandable conduit is completely sealed.

[0047] Example 42. The device according to any one of examples 37-41, wherein said expandable conduit comprises a plurality of selectively opening perfusion flaps.

[0048] Example 43. The device according to any one of examples 37-42, wherein said inflatable element is a balloon.

[0049] Example 44. The device according to any one of examples 37-43, wherein said inflatable element is built-in within said expandable conduit.

[0050] Example 45. The device according to any one of examples 37-44, wherein said inflatable element is insertable within said expandable conduit after deployment of said expandable conduit.

[0051] Example 46. The device according to any one of examples 37-45, wherein said inflatable element is configured to be translated within said expandable conduit from a proximal position to a distal position and vice versa.

[0052] Example 47. The device according to any one of examples 37-46, wherein said inflatable element is configured to close an opening at a proximal end of said expandable conduit.

[0053] Example 48. The device according to any one of examples 37-47, wherein said inflatable element is configured to close an opening at a distal end of said expandable conduit.

[0054] Example 49. The device according to any one of examples 37-48, wherein said device comprises a compressed configuration and an expanded configuration; and wherein said device is delivered in said compressed configuration and actuated in said expanded configuration.

[0055] Example 50. The device according to any one of examples 37-49, wherein said frame comprises a plurality of struts configured to limit an expansion of said expandable conduit to a predetermined size.

[0056] Example 51. The device according to any one of examples 37-50, wherein said proximal valve comprises leaflets configured to open towards a single direction and wires configured to limit a movement of said leaflets to said single direction.

[0057] Example 52. The device according to any one of examples 37-51, wherein said distal valve comprises leaflets configured to open to a single direction and wires configured to limit a movement of said leaflets to said single direction.

[0058] Example 53. The device according to any one of examples 37-52, further comprising a plurality of connectors connected on one side to said proximal end of said expandable conduit and on another side to an elongated tube; said elongated tube extending proximally until exiting a body of said patient. Example 54. The device according to any one of examples 37-53, wherein said device is deployed or retracted by actuation of said elongated tube.

[0059] Example 55. The device according to any one of examples 37-54, further comprising a plurality of redirection elements positioned on an external surface of said expandable conduit.

[0060] Example 56. The device according to any one of examples 37-55, wherein said expandable conduit comprises a length of from 3cm to 35cm.

[0061] Example 57. The device according to any one of examples 37-56, wherein said device is configured to generate a flow from IL / Min to 8L / Min.

[0062] Example 58. The device according to any one of examples 37-57, wherein said device is configured to provide blood flow to side branches.

[0063] Example 59. The device according to any one of examples 37-58, further comprising one or more decentering elements externally attached to said expandable conduit.

[0064] Example 60. The device according to any one of examples 37-59, further comprising at least one sensor configured to monitor at least one physiological parameter of a patient being treated with said device.

[0065] Example 61. The device according to any one of examples 37-60, wherein said at least one sensor is positioned in at least one location selected from group consisting of: on said device, within said patient but not on said device and externally of said patient.

[0066] Example 62. A method of actuating a device according to any one of claims 37-61, the method comprising: a. deflating said inflatable element, opening said distal valve and closing said proximal valve thereby causing blood to enter said expandable conduit through said distal valve; b. inflating said inflatable element, closing said distal valve, opening said proximal valve, thereby causing blood to exit said expandable conduit via said proximal valve; c. repeating (a) and (b).

[0067] Example 63. The method according to example 62, further comprising causing blood to exit through one or more perfusion flaps.

[0068] Example 64. A device for increasing blood flow, comprising: a. an expandable conduit, comprising an elongated body, a proximal opening positioned at a proximal end of said elongated body and a distal opening positioned at a distal end of said elongated body; b. an inflatable element positioned within said conduit; wherein said conduit is substantially sealed along said elongated body to permit passage of blood through said proximal end and / or said distal end; and wherein said inflatable element is configured to be translated within said expandable conduit from a proximal position to a distal position and vice versa.

[0069] Example 65. The device according to example 64, wherein said expandable conduit comprises a frame and a sleeve.

[0070] Example 66. The device according to example 64 or example 65, wherein said frame is covered by said sleeve.

[0071] Example 67. The device according to any one of examples 64-66, wherein said sleeve is embedded within said frame.

[0072] Example 68. The device according to any one of examples 64-67, wherein said expandable conduit is completely sealed.

[0073] Example 69. The device according to any one of examples 64-68, wherein said expandable conduit comprises a plurality of selectively opening perfusion flaps.

[0074] Example 70. The device according to any one of examples 64-69, wherein said inflatable element is a balloon.

[0075] Example 71. The device according to any one of examples 64-70, wherein said inflatable element is built-in within said expandable conduit.

[0076] Example 72. The device according to any one of examples 64-71, wherein said inflatable element is insertable within said expandable conduit after deployment of said expandable conduit.

[0077] Example 73. The device according to any one of examples 64-72, wherein said inflatable element is configured to close said proximal opening when in said proximal position.

[0078] Example 74. The device according to any one of examples 64-73, wherein said inflatable element is configured to close a said distal opening when in said distal position.

[0079] Example 75. The device according to any one of examples 64-74, wherein said device comprises a compressed configuration and an expanded configuration; and wherein said device is delivered in said compressed configuration and actuated in said expanded configuration.

[0080] Example 76. The device according to any one of examples 64-75, wherein said frame comprises a plurality of struts configured to limit an expansion of said expandable conduit to a predetermined size.

[0081] Example 77. The device according to any one of examples 64-76, further comprising a plurality of connectors connected on one side to said proximal end of said expandable conduit and on another side to an elongated tube; said elongated tube extending proximally until exiting a body of said patient.

[0082] Example 78. The device according to any one of examples 64-77, wherein said device is deployed or retracted by actuation of said elongated tube. Example 79. The device according to any one of examples 64-78, further comprising a plurality of redirection elements positioned on an external surface of said expandable conduit.

[0083] Example 80. The device according to any one of examples 64-79, wherein said expandable conduit comprises a length of from 3cm to 35cm.

[0084] Example 81. The device according to any one of examples 64-80, wherein said device is configured to generate a flow from IL / Min to 8L / Min.

[0085] Example 82. The device according to any one of examples 64-81, wherein said device is configured to provide blood flow to side branches.

[0086] Example 83. The device according to any one of examples 64-82, further comprising one or more decentering elements externally attached to said expandable conduit.

[0087] Example 84. The device according to any one of examples 64-83, further comprising at least one sensor configured to monitor at least one physiological parameter of a patient being treated with said device.

[0088] Example 85. The device according to any one of examples 64-84, wherein said at least one sensor is positioned in at least one location selected from group consisting of: on said device, within said patient but not on said device and externally of said patient.

[0089] Example 86. A method of actuating a device according to any one of examples 64-85, the method comprising: a. allowing blood to enter said expandable conduit while said inflatable element is in a proximal position, said inflatable element is deflated and said proximal opening is closed by said inflatable element; b. translating said inflatable element from said proximal position to a distal position; c. closing said distal opening with said inflatable element; d. inflating said inflatable element thereby partially pumping out blood from said expandable conduit; e. translating said inflatable element from said distal side to said proximal side thereby causing a complete expulsion of blood from said expandable conduit; f. closing said proximal opening; g. deflating said inflatable element; h. repeating (a) to (g).

[0090] Example 87. The method according to example 86, further comprising causing blood to exit through one or more perfusion flaps.

[0091] Example 88. A device for increasing blood flow, comprising: a. an expandable conduit, comprising an elongated body, a proximal end and a distal end; b. an inflatable element positioned within said conduit; c. a distal opening positioned at a distal end of said elongated body of said expandable conduit; d. a unidirectional proximal unidirectional valve, positioned at said proximal end of said conduit and configured to allow flow of blood from said internal volume outside of said expandable conduit; wherein said conduit is substantially sealed along said elongated body to permit passage of blood through said proximal end and / or said distal end.

[0092] Example 89. The device according to example 88, wherein said expandable conduit comprises a frame and a sleeve.

[0093] Example 90. The device according to example 88 or example 89, wherein said frame is covered by said sleeve.

[0094] Example 91. The device according to any one of examples 88-90, wherein said sleeve is embedded within said frame.

[0095] Example 92. The device according to any one of examples 88-91, wherein said expandable conduit is completely sealed.

[0096] Example 93. The device according to any one of examples 88-92, wherein said expandable conduit comprises a plurality of selectively opening perfusion flaps.

[0097] Example 94. The device according to any one of examples 88-93, wherein said inflatable element is a balloon.

[0098] Example 95. The device according to any one of examples 88-94, wherein said inflatable element is built-in within said expandable conduit.

[0099] Example 96. The device according to any one of examples 88-95, wherein said inflatable element is insertable within said expandable conduit after deployment of said expandable conduit.

[0100] Example 97. The device according to any one of examples 88-96, wherein said inflatable element is configured to be translated within said expandable conduit from a proximal position to a distal position and vice versa.

[0101] Example 98. The device according to any one of examples 88-97, wherein said inflatable element is configured to close said distal opening of said elongated body of said expandable conduit.

[0102] Example 99. The device according to any one of examples 88-98, wherein said device comprises a compressed configuration and an expanded configuration; and wherein said device is delivered in said compressed configuration and actuated in said expanded configuration. Example 100. The device according to any one of examples 88-99, wherein said frame comprises a plurality of struts configured to limit an expansion of said expandable conduit to a predetermined size.

[0103] Example 101. The device according to any one of examples 88-100, wherein said proximal valve comprises leaflets configured to open towards a single direction and wires configured to limit a movement of said leaflets to said single direction.

[0104] Example 102. The device according to any one of examples 88-101, further comprising a plurality of connectors connected on one side to said proximal end of said expandable conduit and on another side to an elongated tube; said elongated tube extending proximally until exiting a body of said patient.

[0105] Example 103. The device according to any one of examples 88-102, wherein said device is deployed or retracted by actuation of said elongated tube.

[0106] Example 104. The device according to any one of examples 88-103, further comprising a plurality of redirection elements positioned on an external surface of said expandable conduit.

[0107] Example 105. The device according to any one of examples 88-104, wherein said expandable conduit comprises a length of from 3cm to 35cm.

[0108] Example 106. The device according to any one of examples 88-105, wherein said device is configured to generate a flow from IL / Min to 8L / Min.

[0109] Example 107. The device according to any one of examples 88-106, wherein said device is configured to provide blood flow to side branches.

[0110] Example 108. The device according to any one of examples 88-107, further comprising one or more decentering elements externally attached to said expandable conduit.

[0111] Example 109. The device according to any one of examples 88-108, further comprising at least one sensor configured to monitor at least one physiological parameter of a patient being treated with said device.

[0112] Example 110. The device according to any one of examples 88-109, wherein said at least one sensor is positioned in at least one location selected from group consisting of: on said device, within said patient but not on said device and externally of said patient.

[0113] Example 111. A method of actuating a device according to any one of example 88-110, the method comprising: a. allowing blood to enter said expandable conduit while said inflatable element is deflated and said proximal valve is closed; b. partially inflating said inflatable element causing a closure of the distal opening and closing blood within said expandable conduit; c. completely inflating said inflatable element causing an opening of said proximal valve and a complete expulsion of blood from said expandable conduit; d. deflating said inflatable element; e. repeating (a) to (d).

[0114] Example 112. The method according to example 111, further comprising causing blood to exit through one or more perfusion flaps.

[0115] Example 113. A system for increasing blood flow, comprising: a. a device for increasing blood flow comprising an inflatable element according to any one of the previous examples; b. a control unit configured to expand and contract said inflatable element; c. at least one sensor.

[0116] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0117] BRIEF DESCRIPTION OF THE DRAWINGS

[0118] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0119] In the drawings:

[0120] Figure 1 is a schematic representation of an exemplary system and an exemplary principle of action of the system, according to some embodiments of the invention;

[0121] Figure 2a is a schematic representation of a general configuration of an exemplary chamber, according to some embodiments of the invention;

[0122] Figures 2b-c are schematic representations of exemplary internal frames of exemplary conduits, according to some embodiments of the invention; Figures 3a-c are schematic representations of an exemplary first embodiment of a chamber, according to some embodiments of the invention;

[0123] Figures 3d-f are further schematic representations of an exemplary first embodiment of a chamber, according to some embodiments of the invention;

[0124] Figures 3g-31 are schematic representations of an exemplary chamber with optional redirection elements, according to some embodiments of the invention;

[0125] Figures 4a-b are schematic representations showing phases of the chamber during activation, according to some embodiments of the invention;

[0126] Figures 4c-d are schematic representations of exemplary chambers within blood vessels, according to some embodiments of the invention;

[0127] Figures 5a-b are schematic representations of exemplary optional de-centering elements, according to some embodiments of the invention;

[0128] Figure 5c is a schematic representation of an exemplary optional perfusion flaps, according to some embodiments of the invention;

[0129] Figures 6a-b are schematic representations of an exemplary second embodiment of a chamber, according to some embodiments of the invention;

[0130] Figure 7a is a schematic representation of an exemplary third embodiment of a chamber, according to some embodiments of the invention;

[0131] Figure 7b are schematic representations of actuation of an exemplary valveless chamber, according to some embodiments of the invention;

[0132] Figure 8a is a schematic representation of an exemplary third embodiment of a chamber, according to some embodiments of the invention;

[0133] Figure 8b are schematic representations of actuation of an exemplary hybrid-valve chamber, according to some embodiments of the invention;

[0134] Figures 9a-d are a schematic representation of an exemplary two-step chamber deployment, according to some embodiments of the invention;

[0135] Figure 10 is a flowchart of an exemplary method of treating a patient, according to some embodiments of the invention;

[0136] Figure 11 is a flowchart of an exemplary method of monitoring and treating a patient, according to some embodiments of the invention;

[0137] Figure 12 is a flowchart of an exemplary method of operating a dual- valve chamber, according to some embodiments of the invention;

[0138] Figure 13 is a flowchart of an exemplary method of operating a valveless chamber, according to some embodiments of the invention; and Figure 14 is a flowchart of an exemplary method of operating a hybrid- valve chamber, according to some embodiments of the invention.

[0139] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0140] The present invention, in some embodiments thereof, relates to a deployable intrabody pump and, more particularly, but not exclusively, to a deployable intrabody chamber configured to controllably drive blood.

[0141] Overview

[0142] An aspect of some embodiments of the invention relates to increasing blood flow with a device that is positioned within the blood vessel. In some embodiments, blood flow is increased by pumping (accelerating the flow) the blood already found in the blood vessel. As used herein, the terms “pump” / “pumping” mean “the movement and / or acceleration and / or increase of flow”. In some embodiments, the blood is pumped a directional manner. In some embodiments, the blood is pumped while allowing the use of additional surgical tools. In some embodiments, the blood flow increased by using a dedicated system comprising a chamber device (referred hereinafter just as “chamber”). In some embodiments, the chamber is activated, for example, within an aortic segment in an endovascular approach.

[0143] In some embodiments, the chamber is configured to be similar, both in function and in structure, to a chamber of heart. In some embodiments, the chamber comprises walls defining an internal volume, one or more valves (or valveless - see below) and one or more sources of force that cause the insertion of blood into the chamber and the following ejection of the blood from the chamber. In some embodiments, a potential advantage of providing a chamber having these structures is that it potentially provides the closest physiological solution to blood flow that is closest to an actual ventricle of a heart.

[0144] In some embodiments, the chamber is configured to have a unidirectional flow (proximal to distal in relation to the chamber). In some embodiments, the direction of the valves is chosen depending on the anatomy, for example, whether the chamber is placed in an artery or in a vein. In some embodiments, the chamber is an expandable intra-aortic retrievable device comprising one or more of the following: a conduit being substantially sealed, a balloon (either built-in inside the conduit or configured to be inserted within the conduit) and optionally two valves. In some embodiments, the chamber does not comprise a balloon but a mechanical expanding element. In some embodiments, one valve is placed in a distal end of the elongated body while the other valve is placed on a proximal end of the elongated body. In some embodiments, the device comprises one valve. In some embodiments, the device is valveless. In some embodiments, the balloon is positioned between the valves inside the elongated body. In some embodiments, the balloon is already built-in between the valves. In some embodiments, the balloon is brought into the conduit and between the two valves, after deployment of the conduit. In some embodiments, the balloon is inflated / deflated while being synchronized with the diastole / systole action of the heart. In some embodiments, the balloon is inflated / deflated at higher (or lower) frequencies in relation to the heart. In some embodiments, the chamber is positioned below the left subclavian artery and above the renal arteries.

[0145] In some embodiments, a potential advantage of the chamber is that it potentially provides a device that is safe and efficient. For example:

[0146] Exemplary potential safety and biocompatibility advantages: In some embodiments, the chamber potentially reduces the trauma of the pumping action. In some embodiments, by isolating the direct forces applied by the actuation of the balloon inside the elongated body, potential trauma and / or risk of fatigue or dissection is reduced or avoided, when compared to un-protected balloons (as in prior art devices). In some embodiments, there is no need to center the device (chamber) inside the blood vessel to allow for the actuation of the device, due to the inherent configuration of the device as a chamber. In some embodiments, the design of the device as a chamber inherently negates the need to center the device, preventing extensive contact with the blood vessel wall and reducing potential whipping effects without needing separate centering structures. In some embodiments, the chamber allows for blood to flow around the chamber even if the internal balloon fails to deflate, potentially avoiding complete occlusion, and providing an additional safety feature to the system. In some embodiments, the pump is based on a balloon actuation, which is potentially safer and less damaging to blood cells (lower hemolysis risk) compared to high-speed rotary pumps. In some embodiments, the chamber allows for side branch perfusion. In some embodiments, the chamber optionally comprises additional features (i.e. perfusion flaps) specifically designed to maintain blood flow to vital side branches while the chamber is deployed.

[0147] Exemplary potential performance and efficacy advantages: In some embodiments, a potential advantage of the chamber is that it potentially provides an effective pulsatile circulatory support for various conditions. In some embodiments, the chamber is configured to actively direct the momentum of blood flow in the intended physiological direction, unlike prior art devices that primarily augment pressure without enabling for full directional control. In some embodiments, the chamber comprises an integrated unidirectional mechanism within an isolated volume which ensures a controlled, directed blood flow, potentially mitigating issues like drawing blood from side branches during operation. In some embodiments, the chamber comprises an elongated body characterized by having a radial stiffness that, at its expanded maximum diameter, mitigates the dissipation of energy lost due to compliance of the vessel (for example the aorta). In some embodiments, a potential advantage of chamber, which does not require anchoring the device to the walls of the blood vessel, is that it allows to reduce the risk of aortic dissection as can happen in prior art devices that require locking the device to the walls of the blood vessel and / or do not shield the vessel wall from forces associated with balloon expansion / s. In some embodiments, the system is configured to increase the blood flow in either a synchronous or an asynchronous manner in relation to the heart beats. In some embodiments, the design of the system allows for synchronous pumping with the heart to provide additional cardiac support; also, asynchronously at higher frequency to potentially replace the LV function (i.e. like market pVADs).

[0148] Exemplary potential design and deliverability advantages: In some embodiments, the chamber is designed to have a minimally invasive profile. In some embodiments, the chamber is designed to have a small crossing profile, facilitating easier and less traumatic delivery, and post procedure vessel closure. In some embodiments, the chamber comprises valves that do not require for the device to be deployed against the blood vessel wall. In some embodiments, the small delivery profile and flexibility of the chamber allow for atraumatic maneuvering within the vasculature. Also, in some embodiments, the chamber is not required to enter the heart or have a necessity of rounding the aortic arch. In some embodiments, the chamber is designed to be expanded significantly at the target location and also to be retrievable, allowing for temporary or longer-term use. In some embodiments, the chamber design allows to generate a compact construction which allows to integrate one or more additional features. In some embodiments, the integrated and compact design of the chamber, comprising the elongated body with fixated valves, potentially allows to generate a shorter overall device length compared to multi-component constructions.

[0149] In some embodiments, as mentioned above, a potential advantage of the system is that it potentially allows the use of additional tools in parallel to the activation of the chamber (e.g. in complicated or high-risk PCI patients), since the chamber does not require the anchoring of the device to the wall of the blood vessel.

[0150] An aspect of some embodiments of the invention relates to an intrabody pump which is deployable. In some embodiments, the invention enables deploying a pump (e.g., blood pump) inside the human body in a manner that it allows the device to be driven inside the body (e.g., endovascularly) in a small cross-section profile, then allowed to be deployed significantly, by transitioning from a small cross-section to a larger cross-section, in the target area. In some embodiments, the system is transferred in a small cross-section configuration and, as the device is flexible, it supports and allows a high level of maneuverability, which is desired to reach the target position within the body. In some embodiments, during the larger cross-section configuration, the system supports effective pumping capability, in the manner that it generates high flow and / or in a safer manner (hence induces relatively less hemolysis). In some embodiments, a potential advantage of the invention is that it potentially provides a system that is safe. In some embodiments, safety is achieve, for example, since the system is configured to generate fluid’s momentum using a ballon (which is repeatedly inflated / deflated inside a chamber having human fluids / blood) and not, for example, by high-speed rotating a propellor / impeller, which can cause significant friction with the human fluid / blood hence often damaging the blood cells and causing hemolysis, which is commonly associated with micro-axial flow pumps known in the art such as ABIOMED® / Impella® (Johnson&Johnson). In some embodiments, a potential advantage of the invention is that it potentially enables an effective pumping action that it does not only generate a momentum to the fluids (e.g. blood), but also directs the vector of the momentum, in order to assure that the flow follows the normal physiological direction (unlike other prior art devices, like the intra-aortic ballon pump, which delivers a momentum to the blood, however does not allow to control the flow direction and in practice delivers some of the pumped blood in an opposite direction relatively to the normal physiological direction). In some embodiments, the system comprises a self-expandable chamber (e.g. tube-like construction), which is placed inside the human cavity which contains the fluid to be pumped (e.g. inside the aorta), a repeatedly inflatable / defeatable ballon (which is synchronized with the fluid pressure and / or the heart pulse and / or the electrical physiological signals such as ECG), optionally two unidirectional expandable valves that are located at the inlet and outlet of the chamber (which direct flow in a single direction). In some embodiments, a potential advantage of the system is that it potentially enables supporting patients which need an intra-body fluid pump (e.g., patients suffering from heart insufficiency or kidney insufficiency, etc.). For example, the system enables to significantly increase the blood flow in the aorta to support patients undergoing high risk coronary intervention and / or treating patients having cardiogenic shock.

[0151] In some embodiments, a potential advantage of the chamber is that it potentially allows to keep the physiological, pulsatile, flow (either when is maintained or when it is enhanced) both when the blood is brought into the chamber and when the blood is ejected from the chamber, since when the blood is brought into the chamber, no negative pressure is applied outside the chamber, which means that blood from the side branches is not pulled out.

[0152] In some embodiments, another potential advantage of the chamber is that it is configured to act as a chamber and actions performed inside the chamber do not affect the environment of the blood vessel. For example, actuation of the chamber does not cause damage to the walls of the blood vessel. Actuation of the chamber does not negatively interfere with the physiological needs of the body.

[0153] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0154] Exemplary principle of action of an exemplary device

[0155] Referring now to Figure 1, showing a schematic representation of an exemplary system and an exemplary principle of action of the system, according to some embodiments of the invention. In some embodiments, an exemplary system 100 comprises a chamber 102 connected to a control unit 104. In some embodiments, the system also comprises at least one sensor 106 configured to monitor at least one physiological parameter of the patient, for example heartbeats and / or the blood pressure. In some embodiments, at least one sensor can be positioned in one or more of the following locations: in the chamber 102 itself (not shown), inside the patient but not on the chamber (not shown), outside the patient in contact with the patient’s body (as schematically shown in Figure 1). In some embodiments, an exemplary principle of action of the present invention relies on the chamber 102 being positioned within a blood vessel 108. In some embodiments, the chamber 102 is configured to increase the blood flow of the blood already found within the blood vessel. As used herein, the terms “pump” / “pumping” mean “the movement and / or acceleration and / or increase of flow”. In some embodiments, the blood flow is increased, as schematically shown by the increased arrows 110, by pumping the blood by means of the chamber.

[0156] In some embodiments, the chamber is as wide as the blood vessel (not shown in Figure 1). In some embodiments, the chamber is narrower than the width of the blood vessel (as schematically shown in Figure 1).

[0157] In some embodiments, the chamber is configured to increase the blood flow in harmony with the natural contractions / rhythm of the heart. In some embodiments, when necessary, the chamber is configured to increase the blood flow at a frequency that is higher than that of the natural contractions / rhythm of the heart (asynchronous activation). In some embodiments the pump is activated in a frequency that is lower than that of the natural contractions / rhythm of the heart (while preferably still with synchronization with the heart’s diastole / systole mechanical and / or electrical signal). In some embodiments, the chamber is controlled and / or actuated from outside the body of the patient by means of the control unit 104.

[0158] In the following paragraphs, several embodiments of exemplary chambers will be explained.

[0159] Referring now to Figure 2a, showing a schematic representation of a general configuration of an exemplary chamber, according to some embodiments of the invention. Same parts are kept with same referral numbers over the entire specification. In some embodiments, an exemplary chamber 102 comprises a conduit 202, an inflatable element 204 (for example a balloon 204) positioned and / or brought within the conduit 202 and optionally two valves 206a-b, one positioned at a distal end of the conduit 202 and another positioned at a proximal end of the conduit 202. In some embodiments, the conduit is made of an expandable frame (e.g. nitinol made) connected with a polymer-made sleeve (e.g. polyurethane and / or silicone, and / or Nylon, etc.). In some embodiments, the conduit is configured to expand to a dimeter between 50%-100% of the vessel’s internal diameter. In some embodiments, optionally, the conduit comprises a tubular shape, optionally a different shape, for example, conic, wavey, convex or concave shape.

[0160] In some embodiments, the ballon is made of a polymeric material (e.g. polyurethane and / or silicone, and / or Nylon, etc.) and is configured to be expanded to fill from about 70% to about 100% of the conduit’s inner lumen (at its expanded state). In some embodiments, the balloon is expanded using a gas, for example Helium, N2O, etc.

[0161] Exemplary conduit 202

[0162] Referring now to Figures 2b-c, showing schematic representation of exemplary internal frames of exemplary conduits, according to some embodiments of the invention. In some embodiments, exemplary conduits 202 are elongated bodies, substantially sealed, comprising a frame 208 made of elastic materials, for example nitinol or polymer materials. In some embodiments, the frame comprises a mesh / braid -like construction which expands using compression and not due the elasticity nature of its component. In some embodiments, the frame 208 is covered with and / or embedded within a sleeve 210, for example one or more of a polymeric layer, a polymeric coating, an ePTFE sleeve, a mesh, polyurethane, silicone, Nylon, etc., which confers the sealing to the conduit. In some embodiments, when referring to the sealing characteristics of the conduit, the conduit can be 100% sealed from a distal end to a proximal end, the conduit can be less than 100% sealed, by means of dedicated apertures positioned along the conduit (see below), the conduit can be selectively sealed - which means that is 100% sealed when blood in brought into the conduit, and partially sealed when the blood is pumped out the conduit (see below). Figure 2b show an exemplary conduit in two configurations, a compressed configuration, which is the configuration used to bring the device into the desired position; and an expanded configuration, which is the configuration used when utilizing the device. In some embodiments, as schematically shown in Figure 2c, the internal frame 208 optionally comprises one or more struts 212 configured to lock the expansion of the conduit 202 to a predetermined maximal diameter, which in turn potentially allows to conserve energy from balloon expansion, maximize out flow. In some embodiments, the struts 212 allow the restriction of the expansion of the conduit to a determined size. In some embodiments, restricting the size of the expansion of the conduit is potentially advantageous because it can potentially allow to conserve the energy of the expansion of the balloon towards the expulsion of blood from the conduit and not towards the unwanted expansion of the conduit, and also, is potentially advantageous because it potentially avoids damage to the walls of the blood vessel by the unwanted contact between the chamber and the walls.

[0163] In some embodiments, the conduit 202 comprises one or more radio-opaque materials (e.g. the frame itself or markers) in order to allow the device to be well observed under fluoroscopy. In some embodiments, additionally, a conduit which is made of a combination of frame and a sleeve, is configured to be well observed under ECHO / Ultra-Sonic imaging means.

[0164] In some embodiments, the conduit 202 comprises an internal sleeve configured for enhancing the sealing.

[0165] Exemplary balloon 204

[0166] In some embodiments, an exemplary balloon 204 is made of a polymeric material (e.g. polyurethane and / or silicone, and / or Nylon, etc.) and / or reinforced Kevlar and is configured to be expanded to fill from about 70% to about 100% of the conduit’s inner lumen (at its expanded state). In some embodiments, the balloon is expanded using a gas, for example Helium, N2O, etc. In some embodiments, the exemplary balloon is configured to be inflated or deflated within the conduit 202 by means of a pump optionally located in the control unit 104.

[0167] Exemplary valves 206a-b

[0168] In some embodiments, the exemplary valves 206a-b are unidirectional valves configured to allow passage of blood in one direction only. In some embodiments, exemplary valves 206a-b are made of and / or constructed using a silicon layer (or polymeric and / or pericardial layer) having leaflets with slits. In some embodiments, the leaflets of the valve can be made of one or more of polyurethane, Nylon, Polyethylene, Polyester, polyester, silicone, and some bioabsorbable polymers for the frame; Pyrolytic carbon, PTFE, fabric skirts, polyester and other materials for additional / external coatings and covers; Glutaraldehyde coatings for valves with porcine or bovine tissue etc. In some embodiments, optionally, the leaflets are embedded with one or more of a metal / alloy (e.g. nitinol) - to enhance their flexibility; and a radio-opaque material (e.g. gold, tantalum, platinum, Tungsten, etc.) - to allow the device to be well observed under fluoroscopy. In some embodiments, optionally, the leaflets (and / or the conduit’s inner and / or outer surface) are coated with friction reduction polymer (e.g. PTFE and / or Parylene) to potentially minimize friction with the blood (as it flows over them) and potentially decrease the risk for thrombus formation over them.

[0169] Exemplary deployment mechanism

[0170] In some embodiments, exemplary chambers 102 are self-expandable bodies comprising a compressed configuration and an expanded configuration. In some embodiments, the exemplary chambers 102 are configured to change configurations as needed, for example, an exemplary chamber 102 is inserted into a delivery system (for example a tube or a catheter), and the insertion brings the chamber 102 into a compressed configuration (which is allowed due to the elastic characteristics of the chamber), and releasing the chamber from the delivery system provides the necessary space for the chamber 102 to self-expand and reach the expanded configuration. In some embodiments, the chamber is deployed without a balloon, and later a balloon is brought into the already expanded chamber. In some embodiments, the expansion is assisted by inflating the balloon 204 located within the chamber 102. In some embodiments, retraction of the chamber 102 back into the delivery system brings the chamber 102 back into the compressed configuration. In some embodiments, the compressed configuration allows the device to have a small cross-section which supports atraumatic maneuverability. In some embodiments, a potential advantage of first deploying the chamber and later deploying the balloon is that it potentially allows to an even smaller cross-section of the device in the compressed configuration.

[0171] Exemplary first embodiment of an exemplary chamber 300

[0172] Referring now to Figures 3a-c, showing schematic representation of an exemplary first embodiment of a chamber 300, according to some embodiments of the invention. Figure 3a shows a schematic representation external view of an exemplary chamber 300, Figure 3b shows a crosssection view of an exemplary chamber 300 as shown in Figure 3a, Figure 3c shows an exploded view of an exemplary chamber 300 and a distal valve (with its components). In some embodiments, an exemplary chamber 300 comprises a conduit 202 (substantially sealed) and two unidirectional valves 206a-b, one (206a) positioned at a distal end of the conduit 202 and another (206b) at a proximal end of the conduit 202. In some embodiments, exemplary valves 206a-b are made of and / or constructed using a silicon layer (or polymeric and / or pericardial layer) having leaflets 302 with slits 304. In some embodiments, the valves are configured to be unidirectional valves by limiting the opening movement of the leaflets 302 to a single direction using for example wires 306 which are either fixated to the conduit 202 or are an integral part of the internal frame of the conduit 202. In some embodiments, as shown for example in Figures 3a and 3b, the valves 206a-b are fixated at the proximal and distal ends of the chamber 300. In some embodiments, as wires 306 are placed distally (in a distal direction in relation to the chamber 300) to the leaflets 302 (in both chamber’s 300 ends), the leaflets 302 can be opened only proximally (in a proximal direction in relation to the chamber 300), hence, assuring a single flow direction (distal to proximal one).

[0173] In some embodiments, alternatively, the leaflets 302 can be assembled distally to the wires 306 (not shown) so the chamber 300 will generate flow in the opposite direction (i.e. proximal to distal direction), hence optionally support veins blood flow (e.g. the vena cava blood flow).

[0174] Referring now to Figures 3d-f, showing further schematic representations of an exemplary first embodiment of a chamber 300, according to some embodiments of the invention. Figure 3d shows a schematic representation external view of an exemplary chamber 300 connected to a tube, Figure 3e shows a schematic representation external view of an exemplary chamber 300 connected to a tube and having an additional external tube; and Figure 3f shows a cross-section view of an exemplary chamber 300 as shown in Figure 3e.

[0175] In some embodiments, the exemplary chamber 300 comprises a plurality of bars (or struts, wires, connectors) 308 extending proximally from a proximal end of the chamber 300, and connected to an elongated tube 310 which extends proximally optionally until reaching a handle (not shown). In some embodiments, the plurality of bars 308 are integral extensions of and from the tube 310 (for example by using laser cutting techniques) and are made from an elastic material (e.g. Nitinol) having a natural laterally open shape (when they are not constrained). In some embodiments, the tube 310 extends within an external tube 312. In some embodiments, the tube 310 is configured to move proximally and distally within the external tube 312. In some embodiments, the external tube 310 is configured to move proximally and distally in relation to the tube 310 and therefore in relation to the chamber 300. In some embodiments, in either case, the chamber 300 is configured to be either deployed (expanded) or retracted (compressed) by moving either the tube 310 in relation to the external tube 312 or by moving the external tube 312 in relation to the tube 310.

[0176] In some embodiments, as shown for example in Figure 3f, the tube 310 is assembled over inflation tube 314 which is connected to the ballon 204. In some embodiments, a gas (for example Helium) is delivered via the inflation tube 314 to inflate the balloon 204 (hence substantially filling chamber’s 300 volume with the balloon and pushing out in a proximal direction the blood within the chamber), while extracting the gas deflates the ballon 204 (hence bringing blood into chamber’s 300 lumen from the distal end of the chamber). In some embodiments, the balloon 204 is built-in inside the chamber. In some embodiments, the balloon is an independent element configured to be brought into the chamber, optionally after deployment of the chamber.

[0177] In some embodiments, the delivery and extraction of gas into and from the balloon are controlled from the control unit 104, and it is optionally synchronized with the heart beats. For example, the chamber 300 is placed inside the aorta and the balloon 204 is inflated during diastole and deflated during systole.

[0178] In some embodiments, optionally the synchronization with the heart beats can be done by using a pressure gauge (not shown) assembled at the distal end of the chamber 300. In some embodiments, synchronization with the heart beats can be done by using other sensors, for example sensors positioned inside the body of the patient but not on the device itself, or for example sensors located externally, on the patient. In some embodiments, the pressure gauge (or any other sensor) controls the inflation / deflation of the balloon using a blood pressure curve). In some embodiments, the synchronization with the heart beats can be done by measuring the heart’s electrical signals (e.g. using ECG) that indicates the heart’s systole / diastole condition, for example using sensor 106. In some embodiments, the same sensors are used to monitor the state of the patient and, if required, actuate the chamber in a non-synchronous manner in relation to the heart, for example, by increasing the frequency of pumping.

[0179] Exemplary redirection elements

[0180] Referring now to Figures 3g-31 showing schematic representations of an exemplary chamber with optional redirection elements 316, according to some embodiments of the invention. Figure 3g shows a schematic representation external perspective view of an exemplary chamber 300 with optional redirection elements 316; Figure 3h shows a schematic representation external side view of an exemplary chamber 300 with optional redirection elements 316; Figure 3i shows a schematic representation external perspective view of an exemplary chamber 300 with optional redirection elements 316, inside a blood vessel 108; Figure 3j shows a schematic representation cross-section side view of an exemplary chamber 300 with optional redirection elements 316, inside a blood vessel 108; Figure 3k shows a schematic representation external perspective crosssection view of an exemplary chamber 300 with optional redirection elements 316, inside a blood vessel 108; and Figure 31 shows a schematic representation external perspective view of an exemplary chamber 300 with optional redirection elements 316, inside a blood vessel 108 showing side branches.

[0181] In some embodiments, an exemplary chamber 300 comprises additional optional elements. For example, the chamber comprises optional redirection elements 316. In some embodiments, the redirection elements 316 are additional elements added to the chamber. In some embodiments, the redirection elements 316 are built-in elements in the conduit 202. In some embodiments, the redirection elements are configured to enable provision of blood flow to side branches 112 in the blood vessel 108 (e.g. to assure that the chamber 300 does not block the blood flow to side branches 112 when it is placed inside the blood vessel 108 - for example inside the aorta). The optional redirection elements 316 shown in Figures 3g-3k are exemplary additional elements added to the chamber.

[0182] In some embodiments, the optional redirection elements 316 comprise one or more elastic arms 318 fixated to the chamber 300 along its circumference. In some embodiments, the one or more elastic arms 318 are made of an elastic material (for example, nitinol and / or polymeric material) and are configured to self-deploy laterally, while still configured to straightened along the longitudinal axis of the chamber 300, once they are contained (not shown) inside tube 312. In some embodiments, between the one or more elastic arms 318 there are a plurality of circumferential valves 320, which are optionally made of a silicon layer having slits 322), that are connected on each side to an elastic arm 318. In some embodiments, optionally, the optional redirection elements 316 comprise a wire 324 which is connected to the distal sides of the one or more elastic arms 318 and is configured to limit the opening of the leaflets of the circumferential valves 320 to a single direction (towards the proximal direction only), hence providing circumferential valves 320 that enable blood flow in the distal to proximal direction only (optionally, should wire 324 be connected proximately to circumferential valves 320, it would enable blood flow in the opposite direction).

[0183] In some embodiments, once the external tube 312 slides distally (relatively to tube 310), chamber 300 (including the circumferential valves 320) is fully shrunk into the external tube 312 (not shown) and in this configuration the chamber 300 is delivered into the human cavity (e.g. driven within the Aorta) having a small cross section to support atraumatic maneuverability. In some embodiments, once the external tube 312 slides proximately (relatively to tube 310), the chamber 300 (including the circumferential valves 320) fully expands, as schematically shown in Figures 3g-3k.

[0184] Figures 3i-k schematically show the operation of the chamber 300 inside the blood vessel, for example the aorta. In some embodiments, once the ballon 204 is inflated, the blood pressure inside the chamber 300 increases and the blood flows proximately (since the leaflets of the proximal valve 206b open while the leaflets of the distal valve 206a are closed). In some embodiments, once the ballon 204 is deflated, a negative pressure inside the chamber 300 occurs (relatively to the pressure of the surrounding blood) and blood is sucked into the chamber 300 from its distal side (since the leaflets of the distal valve 206a get opened while the leaflets of the proximal valve 206b are closed). Consequently, the repeated actions of inflating and deflating of the ballon 204 continuously pump blood and enhance the blood flow from the distal side towards the proximal side of the chamber 300.

[0185] In some embodiments, optionally, the chamber 300 is strategically positioned inside the blood vessel 108 so the segments between the optional redirection elements 316 (the longitudinal segment in between consecutive circumferential valves 320) are positioned adjacent to side branches 112 (Figure 31), enabling blood flow to enter the side branches 112 them as well. In some embodiments, optionally, the circumferential valves 320 act as spacers configured to keep a margin between the chamber 300 and the side branches 112, to avoid blocking them.

[0186] Exemplary mechanism of action of an exemplary chamber

[0187] Referring now to Figures 4a-b, showing schematic representations showing phases of the chamber during activation, according to some embodiments of the invention. In Figures 4a-b the conduit 202 is shown transparent to allow showing the balloon 204 within the conduit 202.

[0188] In some embodiments, the chamber is deployed having the balloon already inside the chamber. In some embodiments, the chamber is deployed without the balloon, and then the balloon is deployed within the chamber.

[0189] Figure 4a - filling the chamber with blood

[0190] In some embodiments, when the balloon 204 is deflated, the distal valve 206a opens due to the negative pressure generated by the deflation of the balloon 204 inside the chamber 102 / 300 and / or the distal valve 206a opens due to the blood flow passing within the blood vessel (not shown) moving from a distal-to-proximal direction, which can open the distal valve 206a. In some embodiments, when the balloon 204 is deflated, the proximal valve 206b closes due to the negative pressure generated by the deflation of the balloon 204 inside the chamber 102 / 300. In some embodiments, when the distal valve 206a opens, the internal volume of the chamber 102 / 300 fills with blood. Therefore, in summary, deflation of the balloon 204 causes the distal valve 206a to open, the proximal valve 206b to close and blood fills the internal volume of the chamber 102 / 300. In some embodiments, optionally, the chamber is filled during diastolic function of the heart.

[0191] Figure 4b - pumping out the blood from the chamber

[0192] In some embodiments, when the balloon 204 is inflated, the distal valve 206a closes due to the positive pressure generated by the inflation of the balloon 204 inside the chamber 102 / 300. In some embodiments, when the balloon 204 is inflated, the proximal valve 206b opens due to the positive pressure generated by the inflation of the balloon 204 inside the chamber 102 / 300. In some embodiments, when the proximal valve 206b opens, the blood in the internal volume of the chamber 102 / 300 is pumped out the chamber 102 / 300 with a higher flow than the flow outside the chamber 102 / 300. Therefore, in summary, inflation of the balloon 204 causes the distal valve 206a to close, the proximal valve 206b to open and blood within the internal volume of the chamber 102 / 300 to be pumped out the chamber 102 / 300 at higher flow. In some embodiments, optionally, the chamber is emptied during systolic function of the heart. In some embodiments, without being bound to theory, the flow is calculated as: (Vinflated-Vdeflated)*Freq. For example, a balloon having a 50mL volume when expanded, a lOmL volume when deflated and activated 60 times per minutes, the generated flow rate would be (50-10)*60=2.4 L / Min.

[0193] In some embodiments, the chamber is configured to generate a flow of from about 2L / Min to about 5L / Min, optionally from about 1.5L / Min to about 6L / Min, optionally from about IL / Min to about 8L / Min.

[0194] In some embodiments, an increase in the frequency of pumping will cause an increase in the flow per minute. In some embodiments, this can be necessary, for example, when one or more sensors receive an indication that the blood flow has decreased below a certain threshold.

[0195] Referring now to Figures 4c-d, showing schematic representations of exemplary chambers within blood vessels, according to some embodiments of the invention. The Figures show one time the chamber with transparent wall to allow viewing the balloon and another a schematic representation of the device within the blood vessel. Figure 4c shows an exemplary chamber 102 / 300 positioned within a blood vessel, for example the aorta. It can be seen that optionally the chamber 102 / 300 comprises a relative short length, for example a length from about 4cm to about 10cm. Figure 4d shows an exemplary chamber 102 / 300 positioned within a blood vessel 108 showing also the side branches 112, for example the aorta. It can be seen that the chamber 102 / 300 is comprises a relative long length, for example a length from about 10cm to about 25cm. In some embodiments, the length of the chamber is from about 10cm to about 20cm, optionally from about 5cm to about 25cm, optionally form about 3cm to about 35cm.

[0196] It can be seen, in either Figure 4c or Figure 4d, that the chamber 102 / 300 is not centralized in relation to the blood vessel. In some embodiments, the chamber 102 / 300 is not required to be centralized with the blood vessel in order to be activated, this is due to the fact that the device works as an independent pump chamber without the need to be held against the walls of the blood vessel. In some embodiments, a potential advantage of not needing to centralize the chamber and / or not needing to anchor the chamber to the walls of the blood vessel is that it potentially prevents obstructing the side branches 112 and also potentially prevents causing damage to the walls to the blood vessel.

[0197] Exemplary additional optional elements

[0198] In some embodiments, as mentioned above, exemplary chambers 102 / 300 can comprise one or more additional optional elements.

[0199] Figures 3g-3k show exemplary optional redirection elements 316.

[0200] Figures 5a-b schematically show exemplary (optional) de-centering elements 502. In some embodiments, as mentioned above, the chambers are not needed to be centralized with the blood vessel. In some embodiments, the chambers optionally comprise dedicated de-centering elements 502 configured to ensure that the chamber is not centralized and therefore potentially preventing obstructing the side branches 112 and also potentially preventing causing damage to the walls to the blood vessel. In some embodiments, the chamber may comprise one or more de-centering elements 502 positioned in a proximal location and / or in a distal location and / or along the length of the chamber and / or having a proximal-distal orientation or a distal-proximal orientation.

[0201] Figure 5c schematically show exemplary (optional) perfusion flaps 504 positioned along the conduit 202 of the chamber 102 / 300. In some embodiments, the perfusion flaps 504 are configured to allow blood to flow, not only proximally, but also to the sides of the chamber, in order to potentially allow provision of blood flow into the side branches 112. In some embodiments, when the optional perfusion flaps 504 are present, the conduit is selectively sealed. For example, when blood is inserted into the chamber, the perfusion flaps 504 are closed, and the conduit is sealed. When the blood is pumped out the chamber, the perfusion flaps 504 open, making the conduit not- sealed. In some embodiments, a potential advantage of this selective sealing is that it avoids taking out blood from the side branches during the insertion of blood into the chamber, while allowing flow of blood into the side branches during expulsion of blood from the chamber. Exemplary second embodiment of an exemplary chamber 600

[0202] Referring now to Figures 6a-b showing schematic representations of an exemplary second embodiment of a chamber 600, according to some embodiments of the invention.

[0203] The main difference between the chamber 102 / 300, shown in Figures 3c-i, Figures 4a-d and Figures 5a-c and the chamber 600 shown in Figures 6a-b is the configuration of the unidirectional valves.

[0204] In some embodiments, exemplary chamber 600 comprises a distal unidirectional valve 602a and a proximal unidirectional valve 602b.

[0205] In some embodiments, the unidirectional valves 602a-b are shaped like a dome, or defined as a rounded vault forming the valve structure, having a circular base, or defined as a shape of half a sphere (referred hereinafter just as “dome”). In some embodiments, the unidirectional valves 602a-b work similar to sails. In some embodiments, the unidirectional valves 602a-b are passively actuated thanks to the inflation / deflation of the balloon.

[0206] In some embodiments, the unidirectional valves 602a-b do not require the use of exemplary wires 306 (see Figure 3c), as there is no need for physical limiters in the unidirectional valves 602a- b due to their dome configuration.

[0207] Figure 6a, similarly to Figure 4a, shows that when the balloon 204 is deflated, the distal valve 602a opens due to the negative pressure generated by the deflation of the balloon 204 inside the chamber 600 and / or the distal valve 602a opens due to the blood flow passing within the blood vessel (not shown) moving from a distal-to-proximal direction, which can open the distal valve 602a. In some embodiments, when the balloon 204 is deflated, the proximal valve 602b closes due to the negative pressure generated by the deflation of the balloon 204 inside the chamber 600. In some embodiments, when the distal valve 602a opens, the internal volume of the chamber 600 fills with blood. Therefore, in summary, deflation of the balloon 204 causes the distal valve 602a to open, the proximal valve 602b to close and blood fills the internal volume of the chamber 600. In some embodiments, optionally, the chamber is filled during diastolic function of the heart.

[0208] Figure 6b, similarly to Figure 4b, shows that when the balloon 204 is inflated, the distal valve 602a closes due to the positive pressure generated by the inflation of the balloon 204 inside the chamber 600. In some embodiments, when the balloon 204 is inflated, the proximal valve 602b opens due to the positive pressure generated by the inflation of the balloon 204 inside the chamber 600. In some embodiments, when the proximal valve 602b opens, the blood in the internal volume of the chamber 600 is pumped out the chamber 600 with a higher flow than the flow outside the chamber 600. Therefore, in summary, inflation of the balloon 204 causes the distal valve 602a to close, the proximal valve 602b to open and blood within the internal volume of the chamber 600 to be pumped out the chamber 600 at higher flow. In some embodiments, optionally, the chamber is emptied during systolic function of the heart.

[0209] Exemplary third embodiment of an exemplary chamber 700

[0210] Referring now to Figure 7a showing a schematic representation of an exemplary third embodiment of a chamber 700, according to some embodiments of the invention.

[0211] In some embodiments, exemplary chambers do not comprise either proximal nor distal unidirectional valves, meaning that, in some embodiments, the chamber is valveless.

[0212] In some embodiments, an exemplary valveless chamber 700 comprises one or more of:

[0213] 1. A conduit 702: comprising an elongated body, a distal opening 706a and a proximal opening 706b;

[0214] 2. A balloon 204 positioned within the conduit 702;

[0215] 3. A balloon actuator 704, connected to a proximal end of the balloon 204, and extending proximally to a handle or an actuator (not shown), either outside the patient. In some embodiments, the balloon actuator 704 is configured to perform at least two actions: a. Allow the inflation / deflation of the balloon 204 by allowing the insertion / extraction of gases into and from the balloon 204; b. performing a movement of the balloon 204 inside the conduit 704 along a longitudinal axis of the conduit 704, for example, a movement forwards and backwards and / or a movement distally and proximally. In some embodiments, the movement is performed at any state of the balloon 204, for example, movement can be performed when the balloon 204 is inflated, when the balloon 204 is deflated or at any state in between inflation / deflation.

[0216] In some embodiments, the sizes of the distal opening 706a and the proximal opening 706b are as big as the size of the balloon 204 in a deflated configuration, for example, in an inflated configuration, the exemplary balloon 204 occupy from about 50% to about 100% of the conduit 202 inner volume. In some embodiments, the balloon is configured to occupy from about 60% to about 95% of the conduit inner volume. In some embodiments, the size of the distal / proximal opening is about 3mm. In some embodiments, the balloon 204 comprises dedicated caps (not shown) at a distal end and at a proximal end of the balloon 204, configured to engage the distal opening 706a and the proximal opening 706b, accordingly, to ensure, on one side, proper closure of the openings, and on the other side, to protect the integrity of the balloon 204 during operation. Exemplary actuation of the valveless chamber 700

[0217] Referring now to Figure 7b, showing schematic representations of actuation of an exemplary valveless chamber 700, according to some embodiments of the invention.

[0218] In some embodiments, the valveless chamber 700 is actuated in cyclical manner to enable pumping of blood. In some embodiments, the cycle is characterized by two distinct states of the balloon 204: inflation / deflation of the balloon and translation of the balloon from a distal position (referred just as “forwards” or “forward position”) to a proximal position (referred just as “backwards” or “backward position”), and vice versa. In some embodiments, an exemplary cycle comprises one or more of the following steps:

[0219] 1. Deflation of the balloon - balloon backwards;

[0220] 2. Translation of the balloon from backward position to forward position;

[0221] 3. Inflation of the balloon - balloon forwards;

[0222] 4. Translation of the balloon from forward position to backward position;

[0223] 5. Repeating steps 1-4.

[0224] In some embodiments, deflation of the balloon 204 while in the backward position pulls blood into the conduit 702.

[0225] In some embodiments, translation of the balloon 204 from a backward position to a forward position locks the blood within the conduit 702 by closing the distal opening 706a.

[0226] In some embodiments, inflation of the balloon 204 while in the forwards position begins the process of pushing the blood from within the conduit 702 outside the conduit 702 via the proximal opening 706b.

[0227] In some embodiments, translating the inflated balloon 204 from a forward position to a backward position concludes the process of pushing the blood from within the conduit 702 outside the conduit 702 via the proximal opening 706b.

[0228] In some embodiments, the process of pushing the blood from within the conduit 702 outside the conduit 702 via the proximal opening 706b comprises increasing the flow of blood in relation to the flow outside the chamber 700. In some embodiments, the chamber is configured to increase the blood flow of about 2L / min or higher.

[0229] In some embodiments, when positioning the chamber in a vein, actuating the chamber in a reverse sequence will induce flow in an opposite direction.

[0230] Exemplary fourth embodiment of an exemplary chamber 800

[0231] Referring now to Figure 8a showing a schematic representation of an exemplary third embodiment of a chamber 800, according to some embodiments of the invention. In some embodiments, an exemplary chamber 800 comprises a proximal valve but does not comprise a distal valve, meaning that, in some embodiments, the chamber is a hybrid-valve chamber.

[0232] In some embodiments, an exemplary hybrid- valve chamber 800 comprises one or more of:

[0233] 1. A conduit 802: comprising an elongated body, a distal opening 804 and a proximal directional valve 806;

[0234] 2. A balloon 204 positioned within the conduit 802; In some embodiments, the balloon 204 comprises a geometry configured to engage with the distal opening 804 when the balloon 204 is inflated (see below and Figure 8b).

[0235] 3. A balloon actuator 808, connected to a proximal end of the balloon 204, and extending proximally to a handle or an actuator (not shown), either outside the patient. In some embodiments, the balloon actuator 808 is configured to allow the inflation / deflation of the balloon 204 by allowing the insertion / extraction of gases (or fluid) into and from the balloon 204. In some embodiments, optionally, the balloon actuator 808 provides movement to the balloon 204.

[0236] Exemplary actuation of the hybrid-valve chamber 800

[0237] Referring now to Figure 8b, showing schematic representations of actuation of an exemplary hybrid-valve chamber 800, according to some embodiments of the invention. Figure 8b shows contemporarily a side view and a perspective view of an exemplary hybrid-valve chamber 800 to provide better views of the components and their state during the actuation of the hybridvalve chamber 800.

[0238] In some embodiments, the hybrid-valve chamber 800 is actuated in cyclical manner to enable pumping of blood. In some embodiments, the cycle is characterized by two inflation steps of the balloon 204: a first inflation step where a distal end of the balloon 204 engages the distal opening 804 and a second inflation step when the balloon 204 inflates completely.

[0239] As can be seen in Figure 8b, the balloon 204 comprises an extension 810 at the distal end. In some embodiments, the extension 810 is configured to engage the distal opening 804.

[0240] In some embodiments, an exemplary cycle comprises one or more of the following steps:

[0241] 1. balloon deflated - proximal directional valve 806 closed; At this stage the conduit 802 of the hybrid- valve chamber 800 gets fill with blood (from the passage from inflated to deflated from the previous cycle);

[0242] 2. Partial inflation of the balloon 204 until the extension 810 engages the distal opening 804 closing the opening to prevent further entering of blood and to prevent exiting of blood from the distal opening 804; 3. Fully inflation of the balloon 204 - proximal directional valve 806 opens due to the positive pressure inside the conduit 802 generated by the inflation of the balloon 204 while closing the distal opening 804;

[0243] 4. Repeating steps 1-3.

[0244] In some embodiments, the deflation of the balloon 204 causes the proximal directional valve 806 to close due to the negative pressure generated by the deflation of the balloon 204.

[0245] In some embodiments, the passage from partial inflation to fully inflation is a seamlessly passage (no need to stop inflation between steps).

[0246] Exemplary two-step chamber deployment

[0247] Referring now to Figures 9a-d, showing a schematic representation of an exemplary two- step chamber deployment, according to some embodiments of the invention. In some embodiments, the two steps are: 1. deployment of the chamber without the balloon; and 2. Deployment of the balloon.

[0248] In some embodiments, as mentioned above, a catheter 900 is brought to the place of deployment, then a chamber 102 is brought within the catheter 900 in a compressed configuration to the distal end of the catheter 900 to be deployed, as schematically shown in Figure 9a.

[0249] In some embodiments, the exemplary chamber is allowed to expand by taking it out of the catheter 900, as schematically shown in Figure 9b.

[0250] In some embodiments, the balloon 204 is brought in a compress configuration within the catheter 900 and within the elements holding the chamber, as schematically shown in Figure 9c.

[0251] In some embodiments, the balloon 204 is inserted within the chamber 102 where treatment can begin, as schematically shown in Figure 9d.

[0252] Exemplary methods

[0253] In some embodiments, methods related to one or more of the exemplary chambers disclosed herein include one or more of:

[0254] Referring now to Figure 10, showing a flowchart of an exemplary method of treating a patient by generating pressure and generating an augmented downstream directional flow in a patient’s blood vessel, comprising:

[0255] 1. Selecting a type of chamber 1002. In some embodiments, the type of chamber can be one or more of short chamber, long chamber, two-step deployment chamber, dual valve chamber, valveless chamber and hybrid-valve chamber. 2. Inserting the selected chamber into the blood vessel 1004. In some embodiments, inserting the chamber comprises bringing a catheter, comprising the chamber in a compressed configuration, to the place of deployment and deploying the chamber by pushing out the chamber from the catheter and allowing self-expansion of the chamber.

[0256] 3. In some embodiments, depending on the type of chamber, the method optionally comprises inserting a balloon into the chamber 1006.

[0257] 4. Alternating inflation and deflation of the balloon 1008 within the chamber, thereby generating pressure and generating an augmented downstream directional flow in a patient’s blood vessel.

[0258] In some embodiments, the method further comprises pulling in the chamber within the catheter once the treatment is over. In some embodiments, the method further comprises pulling in the balloon within the catheter prior to pulling in the chamber.

[0259] Exemplary methods performed in real-time

[0260] Without being bound to theory, a healthy heart pumps blood at a flow of about 5L / min.

[0261] In some embodiments, during an operation, the system can be operated in one or more of the following modalities / scenarios:

[0262] 1. When a patient presents a blood flow of about half of a normal blood flow, for example, about 2.5L / min, the chamber is actuated in synchrony with the heart beats, causing a doubling in the blood flow (taking under consideration that an exemplary chamber adds a flow of about 2.4L / min).

[0263] 2. When a patient presents a blood flow that is very low, for example below 1.5L / min, the chamber is actuated in a non- synchronic manner in relation to heart, in order to reach a relatively safe blood flow.

[0264] 3. In some embodiments, as mentioned above, physiological parameters are monitored using one or more sensors, and once a certain parameter reaches a predetermined value, the system is configured to automatically adjust the actuation of the chamber so as to keep the blood flow at a certain safe level. In some embodiments, evaluation of the physiological parameters can be done in any suitable manner, for example, manually by dedicated personnel, automatically by a controller and / or automatically by using any Al module.

[0265] Referring now to Figure 11, showing a flowchart of an exemplary method of monitoring and treating a patient, according to some embodiments of the invention:

[0266] 1. Inserting a chamber into a blood vessel 1102; 2. Monitoring at least one physiological parameter using at least one sensor 1104; In some embodiments, the at least one sensor is for example one or more of: pressure gauge, flow meter, ECG, ultrasonic / doppler, optical flow sensor, etc.

[0267] 3. Actuating the chamber either in a synchronous manner or in an asynchronous manner according to a result of said monitoring 1106.

[0268] Exemplary methods of actuation of exemplary chambers

[0269] In some embodiments, exemplary chambers are actuated according to one or more of the following manners:

[0270] Figure 12 - method of operating a dual valve chamber

[0271] 1. deflating the balloon 1202 - opening distal valve 1204 - closing proximal valve 1206 - blood enters the conduit through the distal valve 1208;

[0272] 2. inflating balloon 1210 - closing distal valve 1212 - opening proximal valve 1214 - blood exits the conduit via the proximal valve and optionally via perfusion flaps 504 1216.

[0273] 3. Repeating inflation / deflation 1218.

[0274] Figure 13 - method of operating a valveless chamber

[0275] 1. Balloon positioned in a proximal side - deflated - proximal opening is closed by the balloon 1302;

[0276] 2. Blood enters the conduit 1304;

[0277] 3. Translating the balloon from a proximal side to a distal side 1306;

[0278] 4. Closing the distal opening with the balloon 1308;

[0279] 5. Inflating the balloon 1310;

[0280] 6. Blood is partially pumped out the conduit 1312;

[0281] 7. Translating the balloon from a distal side to a proximal side 1314 causing complete expulsion of blood from the conduit and closing the proximal opening;

[0282] 8. Deflating the balloon 1316;

[0283] 9. Repeating 1318.

[0284] Figure 14 - method of operating a hybrid-valve chamber

[0285] 1. Balloon deflated - proximal valve is closed 1402;

[0286] 2. Blood enters the conduit 1404; 3. Partially inflating the balloon 1406 causing the closure of the distal opening and closing the blood within the conduit;

[0287] 4. Completely inflating the balloon 1408 causing the opening of the proximal valve and the complete expulsion of blood from the conduit;

[0288] 5. Deflating the balloon 1410;

[0289] 6. Repeating 1412.

[0290] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

[0291] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0292] The term “consisting of’ means “including and limited to”.

[0293] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0294] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0295] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0296] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0297] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art

[0298] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0299] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0300] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0301] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0302] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A device for increasing blood flow, comprising a conduit being substantially sealed configured to pump blood from within said conduit by means of an inflatable element.

2. The device according to claim 1, wherein said conduit comprises an expandable frame and a sleeve.

3. The device according to claim 2, wherein said frame is covered by said sleeve.

4. The device according to claim 2, wherein said sleeve is embedded within said frame.

5. The device according to claim 1, wherein said conduit is completely sealed.

6. The device according to claim 1, wherein said conduit comprises a plurality of selectively opening perfusion flaps.

7. The device according to claim 1 , wherein said device comprises a proximal valve positioned at a proximal end of said conduit.

8. The device according to claim 1, wherein said device comprises a distal valve positioned at a distal end of said conduit.

9. The device according to claim 1, wherein said inflatable element is a balloon.

10. The device according to claim 1, wherein said inflatable element is built-in within said conduit.

11. The device according to claim 1, wherein said inflatable element is insertable within said conduit after deployment of said conduit.

12. The device according to claim 1, wherein said inflatable element is configured to be translated within said conduit from a proximal position to a distal position and vice versa.

13. The device according to claim 1, wherein said inflatable element is configured to close an opening at a proximal end of said conduit.

14. The device according to claim 1, wherein said inflatable element is configured to close an opening at a distal end of said conduit.

15. The device according to claim 1, wherein said device comprises a compressed configuration and an expanded configuration; and wherein said device is delivered in said compressed configuration and actuated in said expanded configuration.

16. The device according to claim 2, wherein said frame comprises a plurality of struts configured to limit an expansion of said conduit to a predetermined size.

17. The device according to claim 7, wherein said proximal valve comprises leaflets configured to open towards a single direction and wires configured to limit a movement of said leaflets to said single direction.

18. The device according to claim 8, wherein said distal valve comprises leaflets configured to open to a single direction and wires configured to limit a movement of said leaflets to said single direction.

19. The device according to claim 1, wherein said device comprises both a proximal valve and a distal valve.

20. The device according to claim 1, wherein said device is valveless.

21. The device according to claim 1, further comprising a plurality of connectors connected on one side to a proximal end of said conduit and on another side to an elongated tube; said elongated tube extending proximally until exiting a body of said patient.

22. The device according to claim 21, wherein said device is deployed or retracted by actuation of said elongated tube.

23. The device according to claim 1, further comprising a plurality of redirection elements positioned on an external surface of said conduit.

24. The device according to claim 1, wherein said conduit comprises a length of from 3cm to 35cm.

25. The device according to claim 1, wherein said device is configured to generate a flow from IL / Min to 8L / Min.

26. The device according to claim 1, wherein said device is configured to provide blood flow to side branches.

27. The device according to claim 1, further comprising one or more decentering elements externally attached to said conduit.

28. The device according to claim 1, further comprising at least one sensor configured to monitor at least one physiological parameter of a patient being treated with said device.

29. The device according to claim 28, wherein said at least one sensor is positioned in at least one location selected from group consisting of: on said device, within said patient but not on said device and externally of said patient.

30. A method of treating a patient by generating pressure and generating an augmented downstream directional flow in a patient’s blood vessel, comprising: a. inserting a device for increasing blood flow into said blood vessel; said device comprising a conduit being substantially sealed configured to pump blood from within said conduit by means of an inflatable element; b. actuating said device to generate said augmented downstream directional flow from within said conduit.

31. The method according to claim 30, wherein said actuating comprises alternating between inflation and deflation of an inflatable element positioned within said device.

32. The method according to claim 30, wherein said inserting comprises bringing a catheter to a location in said blood vessel and further comprises bringing said device in a compressed configuration to said location within said catheter.

33. The method according to claim 30, wherein said inserting comprises deploying said device in said blood vessel before said actuating.

34. The method according to claim 30, further comprising monitoring at least one physiological parameter of said patient.

35. The method according to claim 34, further comprising amending said actuating according to said monitored at least one physiological parameter.

36. The method according to claim 30, further comprising extracting said device at the end of said treating.

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