Blood pump

Abstract

Devices and methods are described for use with a venous system of a subject, the venous system including one or more branch vessels flowing into a vein at a connection. A blood pump catheter (70) includes a body of material (36) configured to be placed at a downstream position downstream of the connection and to at least partially block blood flow through the vein. The body of material defines a blood outlet opening (31). A blood pump (24) pumps blood from a region of the vein adjacent to the connection and passes the blood through the blood outlet opening (31). A blood flow path (60) directs upstream venous blood flow from an upstream position upstream of the connection to downstream of the body of material (36), while the upstream venous blood flow is not pumped by the pump (24). Other applications are also described herein.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority from the following applications:

[0003] U.S. Provisional Patent Application No. 62 / 851,769, filed by Friedland on May 23, 2019, entitled “Blood pumps”;

[0004] U.S. Provisional Patent Application No. 62 / 870,822 filed by Friedland on July 5, 2019, entitled “Blood pumps”;

[0005] U.S. Provisional Patent Application No. 62 / 890,177, filed by Friedland on August 22, 2019, entitled “Blood pumps”; and

[0006] Friedland, U.S. Provisional Patent Application 62 / 983,786, filed on March 2, 2020, and entitled “Blood pumps.”

[0007] Each of the applications cited above is incorporated herein by reference.

[0008] Field of the Invention

[0009] Some applications of the present invention relate generally to medical devices. In particular, some applications of the present invention relate to devices and methods associated with placing a pump in a vein or artery.

[0010] background

[0011] It is very common for cardiac dysfunction or congestive heart failure to develop into renal dysfunction, and renal dysfunction can cause the symptoms of congestive heart failure to develop or worsen. Usually, cardiac systolic dysfunction and / or cardiac diastolic dysfunction lead to systemic venous congestion, which leads to increased renal vein and interstitial pressure. The increase in renal vein and interstitial pressure usually leads to the development of both renal dysfunction and renal neurohormonal activation, and due to both renal dysfunction and renal neurohormonal activation, the increase in pressure causes the body's fluid retention to increase. The resulting fluid retention causes congestive heart failure to develop or worsen by causing the heart's blood volume overload and / or by increasing systemic resistance. Similarly, it is common for renal dysfunction and / or renal neurohormonal activation to develop into cardiac dysfunction and / or congestive heart failure. Cardiac dysfunction and / or congestive heart failure lead to renal dysfunction and / or renal neurohormonal activation, or renal dysfunction and / or renal neurohormonal activation lead to cardiac dysfunction and / or congestive heart failure, and the pathophysiological cycle in which each dysfunction leads to the worsening of another dysfunction is called cardiorenal syndrome.

[0012] Experiments have shown that increased renal venous pressure leads to azotemia and decreases in glomerular filtration rate, renal blood flow, urine volume, and sodium excretion. Increased renal venous pressure has also been shown to increase plasma renin and aldosterone, as well as protein excretion. Venous congestion may also contribute to anemia via three different pathways: decreased renal erythropoietin production, hemodilution due to fluid retention, and decreased gastrointestinal iron uptake due to inflammatory responses.

[0013] Mechanistically, increased renal venous pressure may lead to increased intracapsular pressure and subsequently to increased interstitial peritubular pressure. By increasing pressure within the Bowman capsule, increased peritubular pressure may affect tubular function (reduced sodium excretion) and reduce glomerular filtration.

[0014] In patients with heart failure, increased renal venous pressure may result not only from increased central venous (right atrial) pressure but also from direct pressure on the renal veins from intraperitoneal fluid accumulation (ascites). Reducing intraabdominal pressure in patients with heart failure by removing fluid (eg, by paracentesis and / or ultrafiltration) has been shown to reduce plasma creatinine levels.

[0015] During physical activity, such as walking, increased venous return due to activation of the "leg muscle pump" may increase systemic venous pressure, especially in patients with heart failure, and may cause backflow into the renal veins.

[0016] Typically, in patients with acute heart failure, elevated systemic venous pressure leads to increased renal parenchymal pressure and increased intra-abdominal pressure, creating factors that may contribute to worsening of renal perfusion and renal function. In addition, high systemic venous pressure may impede lymphatic drainage of pulmonary interstitial fluid, resulting in increased and prolonged pulmonary congestion in patients with acute pulmonary edema.

[0017] Embodiment Overview

[0018] According to some applications of the present invention, the blood flow of the vena cava region adjacent to the junction of the vena cava and the renal vein is separated from the vena cava blood flow upstream and downstream of the subject at the junction. A pump is used to pump blood from the vena cava region adjacent to the junction to a suprarenal position in the vena cava. By directing the blood to bypass the pump, the subject's blood is allowed to flow from an infrarenal position in the subject's vena cava to a suprarenal position without the blood being pumped by the pump.

[0019] For some applications, the method includes (a) at least partially blocking blood flow through the vein by placing a downstream obstruction element (e.g., a body of material) at a downstream position downstream of the connection between the vein and one or more branch vessels (e.g., one or more branch veins), (b) using a pump to pump blood from a region of the vein adjacent to the connection between the vein and the branch vessel through the downstream obstruction element, and (c) directing upstream venous blood flow from an upstream position upstream of the connection between the vein and the branch vessel to downstream of the obstruction element by directing upstream venous blood flow around the pump without pumping the upstream venous blood flow through the pump.

[0020] Typically, this method is performed using a blood pump catheter, which includes a material body configured to be placed in a downstream position downstream of the connection between the vein and the branch vessel, and at least partially blocks the blood flow through the vein at the downstream position. The material body typically defines a blood outlet opening. The blood pump is typically configured to pump blood from a vein region adjacent to the connection between the vein and the branch vessel through the blood outlet opening defined by the material body. The blood flow path (blood-flow pathway) (i.e., the blood flow channel) typically passes between an inlet opening and an outlet opening, the inlet opening being arranged at an upstream position upstream of the connection between the vein and the branch vessel, and the outlet opening leading to the downstream side of the material body. The blood flow path is configured to guide the upstream venous blood flow from the upstream position to the downstream of the material body, while the upstream venous blood flow is not pumped by the pump. For some applications, the blood flow path includes a funnel and one or more tubes. The funnel is configured to be arranged in an upstream position upstream of the connection between the vein and the branch vessel, and one or more tubes are configured to extend from the funnel to the downstream side of the material body. The funnel and the one or more tubes are configured to direct the upstream venous blood flow from the upstream location to downstream of the body of material without the upstream venous blood flow being pumped by the pump.

[0021] In general, the scope of some applications of the present invention includes devices and methods for a subject's venous system, the venous system including branch veins that flow into a main vein (e.g., a renal vein that flows into the vena cava). Typically, such methods include separating blood flow in a region of the main vein adjacent to the junction of the main vein with the branch vein from blood flow in the main vein upstream and downstream of the region, using a pump to pump blood from the region of the main vein adjacent to the junction of the vein with the branch vein to a location in the main vein downstream of the branch vein, and allowing the subject's blood to flow from a location in the main vein upstream of the branch vein to a location in the main vein downstream of the branch vein without being pumped by the pump by directing blood to bypass the pump. The scope of some applications of the present invention also includes devices and methods for a subject's venous system, the venous system including branch vessels (e.g., lymphatic vessels) that flow into the vein. Typically, the method includes separating flow within a region of the vein proximate the junction of the vein with a branch vessel from blood flow within the vein upstream and downstream of the region, using a pump to pump blood from the region of the vein proximate the junction of the vein with the branch vessel to a location within the vein downstream of the region, and allowing the subject's blood to flow from a location within the vein upstream of the branch vessel to a location within the vein downstream of the branch vessel without being pumped by the pump by directing the blood to bypass the pump.

[0022] For some applications of the present invention, a blood pump catheter includes an impeller configured to pump blood by rotation, and an impeller housing configured to be disposed around the impeller. A blood-pump-support frame is typically configured to be disposed upstream of the impeller housing and to at least partially align the longitudinal axis of the impeller housing with the local longitudinal axis of the blood vessel by contacting the inner wall of the blood vessel. The body of material is configured to extend from the impeller housing to the blood pump support frame, thereby contacting the blood vessel wall and occluding the blood vessel in the blood vessel region surrounding the impeller. For some applications, the body of material defines a blood outlet opening, and the impeller is configured to pump blood through the blood outlet opening.

[0023] For some applications, the blood pump catheter is configured for use in the descending aorta of a subject. The blood pump catheter includes a body of material configured to be placed within the descending aorta and to separate the aorta into an upstream compartment and a downstream compartment by at least partially blocking blood flow through the aorta. The body of material typically defines a blood outlet opening. A blood pump (e.g., an impeller-type blood pump) is configured to pump blood through the descending aorta in a downstream direction, through the blood outlet opening.

[0024] In general, in the specification and claims of this application, the term "proximal" and related terms, when such terms are used with respect to a device or a portion of such a device, should be interpreted as meaning the end of the device or the portion of the device that, when inserted into the body of a subject, is generally closer to the location through which the device is inserted into the body of a subject. The term "distal" and related terms, when such terms are used in reference to a device or a portion thereof, should be interpreted as meaning the end of the device or the portion of the device that, when inserted into the body of a subject, is generally farther from the location through which the device is inserted into the body of a subject.

[0025] The terms "downstream" and "upstream" and related terms should be interpreted as being defined relative to the direction of antegrade blood flow through the vasculature of a subject. Thus, for example, the suprarenal vena cava is downstream of the infrarenal vena cava, and the descending aorta is downstream of the aortic arch. When used with respect to a device, the term "upstream" should be interpreted as referring to a portion of the device that is configured to be disposed in a relatively upstream position, while the term "downstream" should be interpreted as referring to a portion of the device that is configured to be disposed in a relatively downstream position.

[0026] Thus, according to some applications of the present invention, there is provided a device for use with a venous system of a subject, the venous system comprising one or more branch vessels, the one or more branch vessels flowing into the vein at a connection between the vein and the one or more branch vessels, the device comprising:

[0027] A blood pump catheter, the blood pump catheter comprising:

[0028] a body of material configured to be placed at a downstream location downstream of the connection and to at least partially obstruct blood flow through the vein at the downstream location, the body of material defining a blood outlet opening;

[0029] a blood pump configured to pump blood from a venous region adjacent the connection and through a blood outlet opening defined by the body of material;

[0030] a blood flow path that passes between (a) a path inlet opening disposed at an upstream position upstream of the connection and (b) a path outlet opening that leads to a downstream side of the body of material,

[0031] The blood flow path is configured to direct upstream venous blood flow from an upstream location to downstream of the body of material without the upstream venous blood flow being pumped by the pump.

[0032] In some applications, a blood pump includes an elongated blood pump tube defining a blood inlet region disposed within an upstream portion of the elongated blood pump tube, a blood outlet region disposed within a downstream portion of the elongated blood pump tube, and an impeller configured to pump blood into the blood inlet region, through the elongated blood pump tube, and out of the blood outlet region.

[0033] In some applications, a blood pump includes an impeller disposed within a frame, the impeller being configured to pump blood by rotating within the frame.

[0034] In some applications, the blood pump catheter is configured to flow into one or more lymphatic vessels of a vein, and the blood pump catheter is configured to be placed within the vein such that:

[0035] The body of material is placed at a downstream location downstream of a connection of the vein to one or more lymphatic vessels and such that blood flow through the vein is at least partially blocked at the downstream location,

[0036] The blood pump is configured to pump blood from a region of the vein adjacent to a junction of the vein with one or more lymphatic vessels and through a blood outlet opening defined by the body of material, and

[0037] a blood flow path passing between (a) a path inlet opening disposed upstream of a region of the vein adjacent to a junction of the vein and one or more lymphatic vessels and (b) a path outlet opening opening to a downstream side of the body of material,

[0038] The blood flow path is configured to direct upstream venous blood flow from an upstream location to a downstream side of the body of material without the upstream venous blood flow being pumped by a pump.

[0039] In some applications, a blood pump catheter is configured to be placed within the vena cava of a subject such that:

[0040] The body of material is placed at a downstream location downstream of a connection of the vena cava to one or more renal veins of the subject and such that blood flow through the vena cava is at least partially blocked at the downstream location,

[0041] The blood pump is configured to pump blood from a region of the vena cava adjacent to a connection of the vena cava with one or more renal veins through a blood outlet opening defined by the body of material, and

[0042] a blood flow path passing between (a) a path inlet opening disposed upstream of a connection between the vena cava and one or more renal veins and (b) a path outlet opening opening to a downstream side of the body of material,

[0043] The blood flow path is configured to direct blood flow from the infrarenal vena cava blood flow to downstream of the body of material, while the infrarenal vena cava blood flow is not pumped by the pump.

[0044] In some applications, the apparatus also includes a percutaneous left ventricular assist device configured to assist left ventricular function of the subject.

[0045] In some applications, a blood pump includes an elongated blood pump tube defining a blood inlet region disposed within an upstream portion of the elongated blood pump tube, a blood outlet region disposed within a downstream portion of the elongated blood pump tube, and an impeller configured to pump blood into the blood inlet region, through the elongated blood pump tube, and out of the blood outlet region.

[0046] In some applications, the elongated blood pump tube is configured to be disposed such that the blood outlet region is disposed within a pulmonary artery of a subject and is configured to pump blood into the pulmonary artery of the subject via the elongated tube.

[0047] In some applications, the device also includes an elongated tube extending downstream from the body of material and defining a suprarenal blood inlet opening, the suprarenal blood inlet opening being configured to be disposed within the suprarenal vena cava of the subject, and the blood inlet region of the elongated blood pump tube being configured to be disposed downstream of the suprarenal blood inlet opening, and the elongated blood pump tube being configured to pump blood from the suprarenal vena cava blood flow into the pulmonary artery of the subject.

[0048] In some applications, the device also includes an elongated tube configured to extend into a pulmonary artery of the subject, and the blood pump is configured to pump blood into the pulmonary artery of the subject via the elongated tube.

[0049] In some applications, the elongated tube defines a suprarenal blood inlet opening that is configured to be disposed within a suprarenal vena cava of a subject, and a blood pump is configured to be disposed downstream of the suprarenal blood inlet opening and to pump blood from the suprarenal vena cava blood flow into a pulmonary artery of the subject.

[0050] In some applications, the diameter of one or more portions of the blood flow path is adjustable such that the flow of blood from the infrarenal vena cava to the right atrium of the subject is adjustable.

[0051] In some applications, the device also includes a blood pressure sensor configured to detect the subject's blood pressure, and a computer processor configured to receive the subject's blood pressure and automatically adjust the diameter of one or more portions of the blood flow path in response to the detected blood pressure.

[0052] In some applications, the diameter of one or more portions of the blood flow path is configured to be adjusted in response to an input.

[0053] In some applications, the blood flow path includes a funnel having a wide end and a narrow end, and one or more tubes, and the wide end of the funnel defines a path inlet opening and the narrow end of the funnel leads to the one or more tubes.

[0054] In some applications, the funnel and the one or more tubes comprise a single continuous blood flow path.

[0055] In some applications, the diameter of one or more portions of the blood flow path is adjustable so that flow through the blood flow path is adjustable.

[0056] In some applications, the device also includes a blood pressure sensor configured to detect the subject's blood pressure, and a computer processor configured to receive the subject's blood pressure and automatically adjust the diameter of one or more portions of the blood flow path in response to the detected blood pressure.

[0057] In some applications, the diameter of one or more portions of the blood flow path is configured to be adjusted in response to an input.

[0058] According to some applications of the present invention, a device is also provided, comprising:

[0059] A blood pump catheter, the blood pump catheter comprising:

[0060] a body of material disposed on the blood pump conduit and configured to at least partially obstruct blood flow through the vein, the body of material defining a blood outlet opening;

[0061] a blood pump configured to pump blood through a blood outlet opening defined by the body of material;

[0062] A blood flow path passes between (a) a path inlet opening and (b) a path outlet opening, wherein the path inlet opening is disposed at a position proximal to the material body and the path outlet opening leads to a position distal to the material body.

[0063] The blood flow path is configured to direct blood flow from the path inlet opening to the path outlet opening without the blood flow being pumped by the pump.

[0064] According to some applications of the present invention, there is also provided a method for treating a venous system of a subject, the venous system comprising a branch vessel flowing into the vein at a junction between the vein and the branch vessel, the method comprising:

[0065] dividing blood flow in a region of the vein adjacent to the junction into a compartment that is separated from blood flow within the vein upstream of the junction and blood flow within the vein downstream of the junction;

[0066] Using a pump, pumping blood from the compartment to a downstream compartment; and

[0067] By directing the blood to bypass the pump, the subject's blood is permitted to flow from a location within the vein upstream of the compartment to a location downstream of the compartment without being pumped by the pump.

[0068] In some applications, pumping blood from a compartment to a downstream compartment includes pumping blood from the compartment to a downstream compartment via an elongated blood pump tube, the elongated blood pump tube defining a blood inlet region disposed within an upstream portion of the elongated blood pump tube, a blood outlet region disposed within a downstream portion of the elongated tube, and an impeller configured to pump blood into the blood inlet region, through the elongated blood pump tube, and out of the blood outlet region.

[0069] In some applications, pumping blood from the compartment to the downstream compartment includes pumping blood from the compartment to the downstream compartment by rotating an impeller.

[0070] In some applications, the method is for one or more lymphatic vessels draining into a vein, and the method includes:

[0071] separating blood flow within a region of the vein adjacent to a junction of the vein with one or more lymphatic vessels into a compartment that separates blood flow within a region of the vein adjacent to a junction of the vein with one or more lymphatic vessels downstream from blood flow within a region of the vein adjacent to a junction of the vein with one or more lymphatic vessels and blood flow within a region of the vein adjacent to a junction of the vein with one or more lymphatic vessels upstream from blood flow within a region of the vein adjacent to a junction of the vein with one or more lymphatic vessels;

[0072] Using a pump, pumping blood from the compartment to a downstream compartment; and

[0073] By directing the blood to bypass the pump, the subject's blood is permitted to flow from a location within the vein upstream of the compartment to a location downstream of the compartment without being pumped by the pump.

[0074] In some applications, the method is applied to a renal vein and a vena cava of a subject, and the method comprises:

[0075] dividing blood flow within a region of the vena cava adjacent to the junction of the vena cava with one or more renal veins into a vena cava compartment that is separated from blood flow within the vena cava downstream of the vena cava compartment and from blood flow within the vena cava upstream of the vena cava compartment;

[0076] Using a pump, pumping blood from the vena cava compartment to a downstream vena cava compartment; and

[0077] By directing the blood to bypass the pump, the subject's blood is permitted to flow from a location upstream of the vena cava compartment to a location downstream of the vena cava compartment without being pumped by the pump.

[0078] In some applications, the method also includes using a percutaneous left ventricular assist device to assist left ventricular function in the subject.

[0079] In some applications, pumping blood from the vena cava compartment to the downstream vena cava compartment includes pumping blood from the vena cava compartment to the downstream vena cava compartment via an elongated blood pump tube, the elongated blood pump tube defining a blood inlet region disposed within an upstream portion of the elongated blood pump tube, a blood outlet region disposed within a downstream portion of the elongated blood pump tube, and an impeller configured to pump blood into the blood inlet region, through the elongated blood pump tube, and out of the blood outlet region.

[0080] In some applications, pumping blood from the vena cava compartment to the vena cava compartment downstream via the elongated blood pump tube includes pumping blood into a pulmonary artery of the subject via the elongated tube.

[0081] In some applications, the method further includes pumping blood from the subject's suprarenal vena cava blood flow to the subject's pulmonary artery via the elongated blood pump tube.

[0082] In some applications, pumping blood from the vena cava compartment to the vena cava compartment downstream includes pumping blood via the elongated tube into a pulmonary artery of the subject.

[0083] In some applications, the method further includes pumping blood from the subject's suprarenal vena cava blood flow into the subject's pulmonary artery via the elongated tube.

[0084] In some applications, directing blood to bypass the pump includes directing blood to bypass the pump via a blood flow path, and the method further includes adjusting blood flow to the subject's right atrium by adjusting a diameter of one or more portions of the blood flow path.

[0085] In some applications, the method further includes detecting a blood pressure of the subject, and adjusting the diameter of the one or more portions of the blood flow path includes automatically adjusting the diameter of the one or more portions of the blood flow path in response to the detected blood pressure.

[0086] In some applications, adjusting the diameter of one or more portions of the blood flow path includes adjusting the diameter of the one or more portions of the blood flow path in response to the input.

[0087] In some applications, directing blood around the pump includes directing blood around the pump via a blood flow path, and the method further includes regulating blood flow through the blood flow path by adjusting a diameter of one or more portions of the blood flow path.

[0088] In some applications, the method further includes detecting a blood pressure of the subject, and adjusting the diameter of the one or more portions of the blood flow path includes automatically adjusting the diameter of the one or more portions of the blood flow path in response to the detected blood pressure.

[0089] In some applications, adjusting the diameter of one or more portions of the blood flow path includes adjusting the diameter of the one or more portions of the blood flow path in response to the input.

[0090] According to some applications of the present invention, there is also provided a method for treating a venous system of a subject, the venous system comprising a branch vessel flowing into the vein at a junction between the branch vessel and the vein, the method comprising:

[0091] at least partially obstructing blood flow through the vein by placing a downstream obstruction element at a downstream location downstream of a connection of the vein to a branch vessel;

[0092] Using a pump, pumping blood from a region of the vein adjacent to a junction of the vein and the branch vessel through the downstream obstruction element; and

[0093] By directing the upstream venous blood flow to bypass the pump, the upstream venous blood flow is directed from an upstream location upstream of the connection of the vein to the branch vessel to downstream of the obstruction element without the upstream venous blood flow being pumped by the pump.

[0094] According to some applications of the present invention, there is also provided a method for treating a venous system of a subject, the venous system comprising a branch vessel flowing into the vein at a junction between the branch vessel and the vein, the method comprising:

[0095] separating blood flow in a region of the vein adjacent to the junction from blood flow in the vein upstream of the region of the vein adjacent to the junction and blood flow in the vein downstream of the region of the vein adjacent to the junction;

[0096] allowing blood to flow from the branch vessel to a location downstream of the branch vessel via the first flow path;

[0097] allowing the subject's blood to flow via the second flow path from a location within the vein upstream of the branch vessel to a location within the vein downstream of the branch vessel; and

[0098] Blood flow is controlled via at least one of the first flow path and the second flow path.

[0099] According to some applications of the present invention, there is also provided a device for an arterial system of a subject, the arterial system comprising an aorta and one or more branch arteries, the one or more branch arteries branching from the aorta at a connection between the aorta and the one or more branch arteries, the device comprising:

[0100] A blood pump catheter, the blood pump catheter comprising:

[0101] a body of material configured to be placed at a downstream location downstream of a junction between the aorta and the branch arteries and to at least partially obstruct blood flow through the aorta at the downstream location, the body of material defining a blood inlet opening;

[0102] a blood pump configured to pump blood from the aorta toward the branch arteries through the blood inlet opening;

[0103] a funnel configured to be disposed upstream of a junction of the aorta with the branch arteries; and

[0104] a blood flow path that passes between (a) a path inlet opening disposed at an upstream position upstream of a junction of the aorta and the branch arteries and (b) a path outlet opening that leads to a downstream side of the material body,

[0105] The blood flow path is configured to direct upstream aortic blood flow from an upstream location of the body of material to a downstream location of the body of material without the upstream aortic blood flow being pumped by the pump.

[0106] According to some applications of the present invention, there is also provided a method for an arterial system of a subject, the arterial system comprising an aorta and one or more branch arteries, the branch arteries branching from the aorta at a connection between the aorta and the one or more branch arteries, the method comprising:

[0107] dividing blood flow in a region of the aorta adjacent to the junction into a compartment that separates blood flow in the aorta downstream of the compartment from blood flow within the compartment;

[0108] Using a pump, blood is pumped from the aorta to the branch arteries; and

[0109] By directing the blood to bypass the pump, the subject's blood is permitted to flow from a location within the aorta upstream of the compartment to a location downstream of the compartment without being pumped by the pump.

[0110] According to some applications of the present invention, there is also provided a method for an arterial system of a subject, the arterial system comprising an aorta and one or more branch arteries, the branch arteries branching from the aorta at a connection between the aorta and the one or more branch arteries, the method comprising:

[0111] at least partially obstructing blood flow through the aorta by placing a downstream obstruction element at a downstream location downstream of a junction of the aorta with a branch artery;

[0112] Using a pump, pumping blood from the aorta to the branch arteries to pass the blood through the downstream obstruction element; and

[0113] By directing the upstream aortic blood flow to bypass the pump, the upstream aortic blood flow is directed from an upstream location upstream of the connection of the aorta to the branch arteries to downstream of the obstruction element without the upstream aortic blood flow being pumped by the pump.

[0114] According to some applications of the present invention, there is also provided a device for use in a descending aorta of a subject, the device comprising:

[0115] A blood pump catheter, the blood pump catheter comprising:

[0116] a body of material configured to be placed within the descending aorta and to separate the aorta into an upstream compartment and a downstream compartment by at least partially obstructing blood flow through the aorta, the body of material defining a blood outlet opening;

[0117] A blood pump is configured to pump blood in a downstream direction through the descending aorta, through the blood outlet opening.

[0118] According to some applications of the present invention, there is also provided a method for treating a descending aorta of a subject, the method comprising:

[0119] dividing the descending aorta into an upstream compartment and a downstream compartment by placing an occluding element in the descending aorta that at least partially occludes the descending aorta; and

[0120] Using a blood pump, blood is pumped from the upstream compartment to the downstream compartment.

[0121] According to some applications of the present invention, a device is also provided, comprising:

[0122] A blood pump catheter configured to be placed within a blood vessel of a subject, the blood pump catheter comprising:

[0123] an impeller configured to pump blood by rotating;

[0124] an impeller housing configured to be disposed around an impeller;

[0125] a blood pump support frame configured to be disposed upstream of the impeller housing and to at least partially align a longitudinal axis of the impeller housing with a local longitudinal axis of the blood vessel by contacting an inner wall of the blood vessel; and

[0126] A body of material is configured to extend from the impeller housing to the blood pump support frame to contact the blood vessel wall and occlude the blood vessel in a region of the blood vessel surrounding the impeller, the body of material defining a blood outlet opening, and the impeller is configured to pump blood through the blood outlet opening.

[0127] The present invention will be more fully understood from the following detailed description of embodiments of the present invention taken in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0129] Figure 1A , Figure 1B and Figure 1C is a schematic diagram of a blood pump catheter placed in the vena cava of a subject according to some applications of the present invention;

[0130] Figure 2A , Figure 2B and Figure 2C is a schematic diagram of a blood pump catheter placed in the vena cava of a subject according to some applications of the present invention;

[0131] Figure 2D is a schematic diagram of a blood pump catheter placed in the vena cava of a subject according to some applications of the present invention, the blood pump having a non-axisymmetric outflow tube;

[0132] Figure 2E is a schematic diagram of a blood pump catheter placed in the vena cava of a subject according to some applications of the present invention, the blood pump having a non-axisymmetric outflow tube and a non-axisymmetric impeller;

[0133] Figure 2F According to some applications of the present invention, in the absence of a subject's anatomical structure, Figure 2E Schematic diagram of a blood pump catheter;

[0134] Figure 3A , Figure 3B , Figure 3C , Figure 3D , Figure 3E , Figure 3F , Figure 3G and Figure 3H Schematic diagram of a blood pump catheter according to other applications of the present invention.

[0135] Figure 4A and Figure 4B is a schematic diagram of a blood pump catheter placed within a descending aorta of a subject proximate to a renal artery of the subject according to some applications of the present invention;

[0136] Figure 5A and Figure 5Bis a schematic diagram of a blood pump catheter placed in a descending aorta (eg, thoracic aorta or abdominal aorta) of a subject according to some applications of the present invention;

[0137] Fig. 6A , Figure 6B , Figure 6C , Fig.6D , Fig. 6E , Fig. 6F , Figure 6G and Figure 6H is a schematic diagram of an impeller or a portion thereof of a blood pump according to some applications of the present invention;

[0138] Figure 7 is a schematic diagram of an impeller disposed within a frame of a blood pump according to some applications of the present invention;

[0139] Fig. 8A and Figure 8B is a schematic diagram of an impeller and a frame of a blood pump in its non-radially constrained state and radially constrained state, respectively, according to some applications of the present invention; and

[0140] Figure 8C is a schematic diagram of a typical bearing assembly used in an axial impeller-based blood pump in the prior art. DETAILED DESCRIPTION

[0141] refer to Figure 1A-Figure 1C , Figure 1A-Figure 1C is a schematic diagram of a blood pump catheter 20 placed within a vena cava 22 of a subject according to some applications of the present invention. Typically, the blood pump catheter includes a blood pump 24, which includes an impeller housing 26 and an impeller 50 disposed inside the impeller housing. Impeller housing 26 (e.g., frame 34 of the housing) is typically used to separate the inner wall of the vena cava from the impeller (e.g., in the event that the vena cava collapses inwardly due to intra-abdominal pressure), so that the vena cava is not damaged by the impeller, and the impeller is not deformed by pressure from the inner wall of the vena cava. More typically, an axial shaft 92 (at Figure 7 The impeller housing is shown in Figure 1 and is supported by radial bearings 116 and 118, which are respectively arranged at the proximal end and the distal end of the impeller housing.

[0142] It should be noted that for the purpose of illustration, Figure 1A-Figure 1C in (and in Figure 2A-2E , Figure 3A-3H , Figure 4A-4B and Figure 5A-Figure 5B ), a three-dimensional view of the blood pump 24 is shown, but other elements of the blood pump conduit are shown in cross-sectional views.

[0143] For some such applications, the blood pump support frame 32 is disposed upstream of the impeller housing 26, and the blood pump support frame 32 is configured to contact the inner wall of the vena cava. The blood pump support frame 32 is configured to align the longitudinal axis of the impeller housing 26, and subsequently the impeller 50, with the local longitudinal axis of the vena cava by contacting the inner wall of the vena cava. (It should be noted that for some applications, the blood pump support frame may not be able to completely align the longitudinal axis of the impeller with the local longitudinal axis of the vena cava. However, typically, the blood pump support frame maintains the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the vena cava better than the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the vena cava in the absence of the blood pump support frame.) Typically, with other conditions being equal, the greater the effectiveness of the impeller 50 in pumping blood, the better the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the vena cava. It should be noted that, typically, although the longitudinal axis of the impeller is slightly misaligned with the local longitudinal axis of the vena cava (e.g., as shown in FIG. 2 ), the impeller 50 is still capable of pumping blood. Figure 2E As a result, however, the impeller will still effectively pump the blood.

[0144] For some applications, the impeller housing 26 includes a frame 34 (e.g., a rigid or semi-rigid frame) made of a shape memory element (e.g., nitinol) that is at least partially covered with a body of material 36 (e.g., a body of material that is impermeable to blood, such as polyester, polyurethane, and / or a different polymer). Typically, for such applications, the rigidity of the frame 34 is sufficiently large that pressure exerted on the frame 34 by the inner wall of the vena cava does not deform the frame. Typically, the body of material 36 extends from the impeller housing to the blood pump support frame 32, thereby contacting the vessel wall and blocking the vessel in the region of the vessel surrounding the impeller and / or upstream of the impeller. The body of material typically defines a hole therethrough at a distal portion of the impeller housing. The body of material is configured to block the backflow of blood around the outside of the impeller, but allows antegrade blood flow in the central region of the vessel near the impeller due to the hole that acts as the blood outlet opening 31. For some applications, a portion of the impeller housing is covered (i.e., lined) on the inside of the impeller housing by a liner 39, for example, as described below with reference to Figure 7 For some such applications, the liner of the impeller housing at least partially overlaps body of material 36. For some applications, the liner extends the blood outlet opening defined by body of material 36.

[0145] Typically, the drive cable 78 is disposed within the outer tube 77 of the blood pump catheter 20. (For example, Fig. 8A More typically, the drive cable extends from a motor 79 disposed outside the subject's body to an axial shaft 92 (at Figure 71 ), the impeller is disposed on an axial shaft 92. The motor transmits rotational motion to the axial shaft (and thus to the impeller) via a drive cable. Typically, the motor is controlled by a computer processor 10. For some applications, the motor is controlled based on blood pressure measurements performed by a pressure sensor 75.

[0146] For some applications, using body 36 in the manner described above reduces the likelihood of retrograde blood flow caused by impeller-induced turbulence in the region of the blood vessel surrounding the impeller. For some applications, the body is used to separate the suprarenal vena cava into an upstream compartment and a downstream compartment, and the impeller is configured to pump blood from the upstream compartment to the downstream compartment, thereby reducing the pressure in the upstream compartment near the renal vein.

[0147] For some applications (not shown), blood pump support frame 32 and frame 34 of impeller housing 26 are formed as a single frame having an upstream portion configured to contact the inner wall of the vena cava and a downstream portion configured to accommodate the impeller.

[0148] Typically, the maximum diameter of the blood pump support frame 32 (i.e., the diameter of the blood pump support frame 32 at the longitudinal position where the diameter of the blood pump support frame 32 is at its maximum value when the blood pump support frame is in its radially unconstrained configuration) is at least 1.1 times (and, for some embodiments, at least 1.3 times) the maximum diameter of the frame 34 of the impeller housing 26 (i.e., the diameter of the frame 34 at the longitudinal position where the diameter of the frame 34 is at its maximum value when the frame 34 is in its radially unconstrained configuration).

[0149] Typically, blood pump 24 is placed downstream of the connection of the vena cava to the subject's renal vein 25 and is configured to pump blood in a downstream direction, thereby reducing the pressure in the subject's renal vein. For some applications, blood pump catheter 20 includes an obstruction element 40 that is configured to be placed upstream of the connection of the vena cava to the subject's renal vein and partially obstruct the vena cava at this location. For example, Figure 1A As shown, the occluding element may include a balloon 42. Alternatively or additionally, the occluding element may include a body of material 44 that is impermeable to blood, the body of material 44 defining a hole 45 therethrough, such as Figure 1B As shown. For some applications, the body of material is supported by a frame 46. Typically, the body of material 44 is configured so that there is some blood flow through the holes in the body of material, but the blood flow is reduced relative to the situation when the body of material is absent. Typically, the obstruction element is configured to partially obstruct the vena cava of the subject upstream of the connection of the vena cava with the renal veins of the subject. For some applications (not shown), the nozzle is used as an upstream obstruction element, such as described in US 2019 / 0239998 to Tuval, which is incorporated herein by reference.

[0150] The obstruction element 40 is configured to partially obstruct the vena cava of the subject so that in response to pumping by the downstream blood pump, there is not a substantial increase in blood flow from the subject's lower body toward the subject's heart, but a low pressure region is created within the vena cava between the obstruction element and the downstream blood pump, wherein the blood pressure within the low pressure region is lower than the subject's central venous pressure. Typically, by creating the low pressure region, blood flow from the renal veins into the vena cava is increased, thereby reducing renal blood pressure and enhancing renal perfusion. It should be noted that the obstruction element is configured to partially obstruct the vena cava, but not completely obstruct the vena cava, in such a way that a low pressure region is created within the vena cava, but a substantial amount of blood is allowed to flow through the vena cava.

[0151] For some applications, blood pump conduit 20 does not include an upstream obstruction element, e.g. Figure 1C As described above, for some applications, body 36 is used to separate the suprarenal vena cava into an upstream compartment and a downstream compartment, and impeller 50 is configured to pump blood from the upstream compartment to the downstream compartment, thereby reducing the pressure in the upstream compartment near the renal vein. For some applications, blood pump catheter 20 is thus configured to create a low pressure area within the vena cava, near the renal vein, even in the absence of an upstream obstruction element, such as Figure 1C Typically, by creating an area of ​​low pressure, blood flow from the renal vein into the vena cava is increased, thereby reducing renal blood pressure and enhancing renal perfusion.

[0152] The blood pump catheter 20 is typically placed in the vena cava 22 of the subject and operates therein to provide emergency treatment for the subject suffering from cardiac dysfunction, congestive heart failure, low renal blood flow, high renal vascular resistance, arterial hypertension, diabetes and / or renal dysfunction. For example, the blood pump catheter can be placed in the vena cava of the subject and operate therein for a period of more than one hour (e.g., more than one day), less than one week (e.g., less than four days) and / or between one hour and one week (e.g., between one day and four days). For some applications, the blood pump catheter is placed in the vena cava of the subject for a long time to provide long-term treatment for the subject suffering from cardiac dysfunction, congestive heart failure, low renal blood flow, high renal vascular resistance, arterial hypertension, diabetes and / or renal dysfunction. For some applications, a course of treatment is applied to the subject in a few weeks, months or years, during which the blood pump catheter is intermittently placed in the vena cava of the subject, and the subject is treated intermittently according to the technology described herein. For example, the subject can be treated intermittently at intervals of several days, weeks or months.

[0153] about Figure 1A-1BThe catheter shown, it should be noted that this catheter includes a blood pump 24 disposed distally relative to the upstream obstruction element, suitable for placement into the vena cava from a vein below the junction of the vena cava with the renal veins of the subject (e.g., the femoral vein). However, the scope of the present invention includes such a catheter having a pump and an obstruction element disposed thereon, but the upstream obstruction element is disposed distally relative to the downstream pump. Mutually, such a catheter is typically inserted via a vein disposed above the inferior vena cava (e.g., the subclavian vein, the jugular vein). Similarly, mutatis mutandis, substantially as Figure 1C The catheter shown can be configured to be inserted into the suprarenal vena cava via a vein disposed above the inferior vena cava (e.g., the subclavian vein or the jugular vein). Typically, in this case, the arrangement direction of the components of the blood pump catheter relative to the axis of the catheter is the same as that of the catheter. Figure 1A-Figure 1C The directions shown are opposite.

[0154] Typically, the blood pump catheter is inserted under fluorescent imaging. Alternatively, the blood pump catheter is inserted under ultrasound imaging, thereby reducing the subject's exposure to radiation and / or contrast agents.

[0155] As described above, blood pump catheter 20 is typically placed in the vena cava of a subject suffering from cardiac dysfunction, congestive heart failure, low renal blood flow, high renal vascular resistance, arterial hypertension, diabetes, and / or renal dysfunction. Typically, running a blood pump catheter in the vena cava of such a subject results in a decrease and flattening of the subject's renal venous pressure curve, even though the subject's central venous pressure is elevated and has additional effects, e.g., as described in reference to US 2016 / 0022890 to Schwammenthal. Figure 4B described herein, which document is incorporated herein by reference.

[0156] As described above, typically, the obstruction element is configured to partially obstruct the vena cava upstream of the connection between the vena cava and the subject's renal vein. For some applications, the diameter to which the obstruction element is expanded is controllable. For example, the expansion of the balloon can be controllable, or the frame can be expandable (e.g., by heating the frame, or by applying an electric current to the frame). For some applications, the degree of obstruction of the vena cava by the obstruction element is controlled by a computer processor 10 in response to the blood pressure detected by the blood pressure sensor 75, in response to inputs from different sensors (such as flow sensors and / or oxygen saturation sensors and / or thermal flow sensors, for example, as described in Figures 22Ai-22Cii of US 2016 / 0022890 of Schwammenthal, which is incorporated herein by reference), and / or in response to inputs from a user. For some applications, the rate at which the pump 24 pumps blood away from the renal vein (e.g., the rate at which the impeller 50 of the pump rotates), and / or the degree of obstruction of the renal vein by the obstruction element is controlled by the computer processor 10 in response to the blood pressure detected by the blood pressure sensor 75, in response to input from a different sensor (e.g., a flow sensor and / or an oxygen saturation sensor, and / or a thermal flow sensor, for example, as described in reference to FIGS. 22Ai-22Cii of US 2016 / 0022890 to Schwammenthal, which is incorporated herein by reference), and / or in response to input from the user. For some applications, the following reference is made to Figure 1C and Figure 2C The described blood pressure sensor is used in conjunction with the above-described apparatus and method.

[0157] Although some applications of the invention are described with reference to a blood pump, according to which the blood pump comprises an impeller, the scope of the invention includes the use of any other type of pump (mutatis mutandis) for pumping blood in the manner described herein. For example, a roller pump, an Archimedean screw pump, a centrifugal pump, a pneumatic pump and / or a compression pump may be used.

[0158] refer to Figure 1A-Figure 1C It should be noted that the scope of the present invention includes the application of similar devices and methods to any venous system of a subject, including branch veins that flow into a main vein. For example, similar techniques can be applied to the junction of the hepatic vein and the vena cava. For some applications, substantially similar devices and methods are used at the junction of the vein with one or more lymphatic vessels within the subclavian vein or jugular vein. For some such applications, blood pump catheter 20 is configured, mutatis mutandis, to increase the flow of lymphatic fluid from the lymphatic vessels into the vein.

[0159] Reference now Figure 2A and Figure 2B , Figure 2A and Figure 2Bis a schematic diagram of a blood pump catheter 70 placed within the vena cava 22 of a subject, according to some applications of the present invention. Typically, blood pump catheter 70 includes blood pump 24, which typically includes impeller housing 26 and impeller 50, all of which are generally as described above. Impeller housing 26 (e.g., frame 34 of the housing) typically acts to separate the inner wall of the vena cava from the impeller (e.g., in the event that the vena cava collapses inwardly due to intra-abdominal pressure), so that the vena cava is not damaged by the impeller, and the impeller is not deformed by pressure from the inner wall of the vena cava. More typically, an axial shaft 92 (at Figure 7 The impeller housing is shown in Figure 1 and is supported by radial bearings 116 and 118, which are respectively arranged at the proximal end and the distal end of the impeller housing.

[0160] For some such applications, the blood pump support frame 32 is disposed upstream of the impeller housing 26, and the blood pump support frame 32 is configured to contact the inner wall of the vena cava. The blood pump support frame 32 is configured to align the longitudinal axis of the impeller housing 26, and subsequently the impeller 50, with the local longitudinal axis of the vena cava by contacting the inner wall of the vena cava. (It should be noted that for some applications, the blood pump support frame may not be able to completely align the longitudinal axis of the impeller with the local longitudinal axis of the vena cava. However, typically, the blood pump support frame maintains the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the vena cava better than the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the vena cava in the absence of the blood pump support frame.) Typically, all other things being equal, the greater the effectiveness of the impeller 50 in pumping blood, the better the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the vena cava. As noted above, typically, despite a slight misalignment of the longitudinal axis of the impeller with the local longitudinal axis of the vena cava (e.g., such as Figure 2E As a result, however, the impeller will still effectively pump the blood.

[0161] For some applications, the impeller housing 26 includes a frame 34 (e.g., a rigid or semi-rigid frame) made of a shape memory element (e.g., nitinol) that is at least partially covered with a body of material 36 (e.g., a body of material that is impermeable to blood, such as polyester, polyurethane, and / or a different polymer). Typically, for such applications, the rigidity of the frame 34 is sufficiently large that pressure exerted on the frame 34 by the inner wall of the vena cava does not deform the frame. Typically, the body of material 36 extends from the impeller housing to the blood pump support frame 32, thereby contacting the vessel wall and blocking the vessel in the region of the vessel surrounding the impeller and / or upstream of the impeller. The body of material typically defines a hole therethrough at a distal portion of the impeller housing. The body of material is configured to block the backflow of blood around the outside of the impeller, but allows antegrade blood flow in the central region of the vessel near the impeller due to the hole serving as the blood outlet opening 31. For some applications, a portion of the impeller housing is covered (i.e., lined) on the inside of the impeller housing by a liner 39, for example, as described below with reference to Figure 7 For some such applications, the liner of the impeller housing at least partially overlaps body of material 36. For some applications, the liner extends the blood outlet opening defined by body of material 36.

[0162] Typically, the drive cable 78 is disposed within the outer tube 77 of the blood pump catheter 70. (For example, Fig. 8A Typically, the drive cable extends from a motor 79 disposed outside the subject's body to an axial shaft 92 (at Figure 7 ), the impeller is disposed on an axial shaft 92. The motor transmits rotational motion to the axial shaft (and thus to the impeller) via a drive cable. Typically, the motor is controlled by a computer processor 10. For some applications, the motor is controlled based on blood pressure measurements performed by a pressure sensor 75.

[0163] For some applications, the blood pump catheter also includes a funnel 72 extending into a tube 74. The funnel is configured to be placed upstream of the connection of the vena cava to the renal vein of the subject and is configured to direct all blood flow from the infrarenal vena cava into the tube 74. Tube 74 then directs the blood flow from the infrarenal location to the suprarenal location in such a way that the blood flows to the suprarenal location by bypassing blood pump 24 (i.e., not being pumped by blood pump 24). For example, a tube 76 may extend from tube 74 to the suprarenal location while bypassing the blood pump. Figure 2A As indicated by the blood flow arrows in FIG. , blood thus flows from the infrarenal vena cava to the suprarenal vena cava without being pumped by the blood pump 24. Figure 2B As indicated by the blood flow arrows in , blood is pumped from the vena cava region adjacent to the junction of the vena cava and the renal veins to the suprarenal vena cava by the blood pump 24 .

[0164] In this way, by deploying the blood pump catheter 70 in the vena cava, the blood flow of the vena cava region adjacent to the junction of the vena cava and the renal vein is separated into a compartment 82, which is separated from the infrarenal vena cava blood flow 84 and the suprarenal vena cava blood flow 86. The blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 occurs passively (e.g., by flowing through the funnel 72, the tube 74 and the tube 76). Using the blood pump, blood is actively pumped from the compartment 82 to the suprarenal blood flow. In this way, the low pressure area in the vena cava is generated in the compartment 82, and in the compartment 82, the blood pressure is lower than the central venous pressure of the subject. Typically, by generating a low pressure area, the blood flow from the renal vein into the vena cava is increased, thereby reducing renal blood pressure and enhancing renal perfusion.

[0165] It should be noted that the specific examples of the configurations of funnel 72, tube 74, and tube 76 are shown as examples, and the scope of the present application includes, mutatis mutandis, any other configurations of blood flow path 60 (i.e., blood flow channel) for directing blood from the infrarenal vena cava to the suprarenal vena cava without pumping through blood pump 24. Typically, funnel 72, tube 74, and tube 76 comprise respective portions of a single continuous blood flow path. The blood flow path typically passes between a path inlet opening 61 and a path outlet opening 63, wherein the path inlet opening 61 is disposed at an upstream position upstream of the connection of the vena cava with the renal veins, and the path outlet opening 63 opens to the downstream side of the body of material 36. Typically, funnel 72 defines a wide end 85 and a narrow end 87, as shown in FIG. Figure 2A The wide end of the funnel typically defines an inlet opening into the blood flow path, while the narrow end of the funnel leads to one or more tubes (eg, tube 74 and tube 76).

[0166] Typically, the blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 is substantially unchanged relative to the blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 in the absence of a blood pump catheter. For some applications, the diameter of one or more portions of the blood flow path 60 is controlled, so that the blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 is controlled. For example, the diameter of one or more portions of the blood flow path (e.g., funnel 72, tube 74, and / or tube 76) can be adjusted (e.g., using an expandable / contractible component disposed inside or outside of one of the funnel 72, tube 74, and / or tube 76). In this way, for example, the preload of the right atrium can be controlled.

[0167] For some applications, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 is controlled in response to (e.g., automatically in response to) one or more pressure measurements, such as pressure measurements performed as described herein. Alternatively or additionally, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 can be periodically adjusted (e.g., in the manner described above). For example, a health care provider (or another person) can periodically adjust blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 in response to changes in the subject's condition (e.g., in the manner described above).

[0168] For some applications, the diameter of one or more portions of blood flow path 60 (e.g., funnel 72, tube 74, and tube 76) is not adjustable, but the diameter of at least a portion of the blood flow path is such that blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 is reduced (relative to the level of blood flow that would occur in the absence of these components), thereby reducing preload on the right atrium.

[0169] Reference now Figure 2C , Figure 2C A schematic diagram of a blood pump catheter 70 according to some applications of the present invention, the blood pump catheter including blood pressure measurement tubes 71, 73. Referring again to Figure 1C , Figure 1C A blood pump catheter 20 including a blood pressure measurement tube 73 is shown in accordance with some applications of the present invention.

[0170] For some applications, at least one blood pressure measuring tube 71 is configured to extend at least to the outer surface of the funnel 72 and / or tube 74, so that the opening at the distal end of the blood pressure measuring tube is in direct fluid communication with the patient's blood flow (e.g., renal vein blood flow) outside the funnel 72 and / or tube 74. The pressure sensor 75 measures the blood pressure in the blood pressure measuring tube. Typically, by measuring the blood pressure in the blood pressure measuring tube, the pressure sensor thereby measures the blood pressure of the subject outside the funnel 72 and / or tube 74, which indicates the renal vein blood pressure. Typically, the blood pressure measuring tube 71 extends from outside the body of the subject to the opening at the distal end of the tube, and the pressure sensor is arranged toward the proximal end of the tube, such as outside the body of the subject. For some applications, the computer processor 10 receives an indication of the measured blood pressure and controls the pumping of blood through the impeller in response to the measured blood pressure.

[0171] For some applications of blood pump catheter 20, blood pump catheter 70, or blood pump catheter 90 (described below), at least one blood pressure measuring tube 73 is configured to extend at least to the outer surface of material body 36 so that an opening at the distal end of the blood pressure measuring tube is in direct fluid communication with the patient's blood flow (e.g., suprarenal vena cava blood pressure) outside of material body 36. Pressure sensor 75 measures the blood pressure within the blood pressure measuring tube. Typically, at Figure 1C and Figure 2C In the example shown, by measuring the blood pressure within the blood pressure measuring tube, the pressure sensor thereby measures the blood pressure of the subject outside the material body 36, which is indicative of the suprarenal vena cava blood pressure. Typically, the blood pressure measuring tube 73 extends from outside the body of the subject to an opening at the distal end of the tube, and the pressure sensor is disposed toward the proximal end of the tube, such as outside the body of the subject. For some applications, the computer processor 10 receives an indication of the measured blood pressure and controls the pumping of blood through the impeller in response to the measured blood pressure. For some applications (e.g., when used in conjunction with a blood pump catheter 70), the computer processor regulates blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 in response to the measured blood pressure (e.g., as described above). For some applications (e.g., when used in conjunction with a blood pump catheter 70), the computer processor regulates blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 in response to the measured blood pressure (e.g., as described above). Figure 1A and Figure 1B The computer processor adjusts the diameter to which the obstruction element 40 is expanded in response to the measured blood pressure when used in conjunction with the blood pump catheter 20 shown.

[0172] As described above, drive cable 78 is typically disposed within outer tube 77 of blood pump catheters 20, 70, and 90. (e.g., Figure 7 A. ) Typically, the drive cable extends from a motor 79 disposed outside the subject's body to an axial shaft 92 on which an impeller is disposed. The motor transmits rotational motion to the axial shaft (and thereby to the impeller) via the drive cable. For some applications, one or more blood pressure measurement tubes 71, 73 are disposed within an outer tube 77 that surrounds the drive cable along at least a portion of the blood pressure measurement tube length.

[0173] like Figure 1C and Figure 2C As shown, for some applications of blood pump catheter 20 or blood pump catheter 70, the blood pressure of the infrarenal vena cava is measured using at least one blood pressure measuring tube, which defines an opening 83 in the outer tube 77 at its distal end. The blood pressure measuring tube is configured to extend from the outside of the subject's body to the outer surface of the outer tube 77 within the subject's infrarenal vena cava, so that the opening at the distal end of the blood pressure measuring tube is in direct fluid communication with the subject's infrarenal vena cava blood flow. The blood pressure sensor 75 is configured to measure the subject's infrarenal vena cava blood pressure by measuring the blood pressure within the blood pressure measuring tube. For some applications (for example, when used as Figure 1A-Figure 1CRenal vein pressure is measured in a substantially similar manner (eg, via a blood pressure measuring tube defining an opening disposed proximate the junction of the renal vein with the vena cava) when a blood pump catheter 20 is provided as shown.

[0174] For some applications, computer processor 10 receives an indication of the measured blood pressure and controls the pumping of blood through the impeller in response to the measured blood pressure. For some applications (e.g., when used with blood pump catheter 70), the computer processor regulates blood flow from infrarenal vena cava blood flow 84 to suprarenal vena cava blood flow 86 in response to the measured blood pressure (e.g., as described above). For some applications (e.g., when used with a blood pump catheter 70), the computer processor regulates blood flow from infrarenal vena cava blood flow 84 to suprarenal vena cava blood flow 86 in response to the measured blood pressure (e.g., as described above). Figure 1A and Figure 1B The computer processor adjusts the diameter to which the obstruction element 40 is expanded in response to the measured blood pressure when used in conjunction with the blood pump catheter 20 shown.

[0175] Typically, there is a relationship between the amount of power required to drive the impeller to rotate at a given rotational rate and the pressure differential created by the impeller. (Typically, the impeller reduces pressure in the vena cava region upstream of body 36 by pumping blood to the vena cava region downstream of body 36, thereby reducing blood pressure in the upstream region and creating a pressure differential between the upstream and downstream regions.) For some applications, calibration measurements are performed so that the relationship between (a) the motor power consumption required to rotate the impeller at a given rotational rate and (b) the pressure differential created by the impeller is known.

[0176] For some applications, the blood pressure upstream of the impeller 50 and the body of covering material 36 is measured, for example, using a blood pressure measuring tube (defining an opening 83 in the outer tube 77 at its distal end), and / or using a pressure sensor (e.g., a piezoelectric pressure sensor, and / or an optical sensor) disposed within the vena cava at a subrenal location. For some such applications, a computer processor then calculates the blood pressure downstream of the impeller 50 and the body of covering material 36 based on (a) the measured upstream blood pressure, (b) the motor power consumption required to rotate the impeller at a given rotational rate at that time, and (c) a predetermined relationship between the motor power consumption required to rotate the impeller at a given rotational rate and the pressure differential generated by the impeller. For some applications, the above techniques are performed while maintaining the impeller rotating at a constant rate. Alternatively or additionally, the rotational rate of the impeller is varied, and the variation in the rotational rate of the impeller is taken into account in the above calculations.

[0177] Typically, the blood outlet opening 31 in the body of material 36 has a known cross-sectional area. For some applications, the flow rate generated by the impeller through the blood outlet opening is determined based on the determined pressure differential generated by the impeller and the known cross-sectional area of ​​the opening. For some applications, this flow calculation incorporates calibration parameters to account for factors such as the flow resistance for the blood pump catheter (or type of blood pump catheter) for which the calculation is being performed.

[0178] For some applications, the above-described apparatus and method for measuring blood pressure are similar to those described above with reference to Figure 1A-Figure 1C The blood pump catheter 20 described above is used in conjunction with Figure 2A-2F The blood pump catheter 70 described herein is used in conjunction with the Figure 3A-3B The blood pump catheter 90 described herein is used in conjunction with and / or in conjunction with the following references Figure 4A-4B The blood pump catheter 20 is described for use with the described blood pump catheter 20.

[0179] Reference now Figure 2D , Figure 2D FIG. 2 is a schematic diagram of a blood pump catheter 70 placed within the vena cava 22 of a subject according to some applications of the present invention, the blood pump having a non-axisymmetric outflow tube 76. Figure 2D The blood pump catheter 70 shown is generally similar to that of reference Figure 2A-2C The blood pump catheter shown and described. Figure 2A-2C In the example shown, the blood pump catheter includes two tubes 76 that are disposed on either side of the longitudinal axis of the blood pump catheter and extend from the tube 74 to a suprarenal location while bypassing the blood pump 24. Figure 2D In the example shown, according to some applications of the present invention, the blood pump catheter includes only a single tube 76, which is disposed on one side of the longitudinal axis of the blood pump catheter and extends from the tube 74 to the suprarenal position while bypassing the blood pump 24. In other aspects, such as Figure 2D The blood pump catheter 70 shown is generally similar to that of reference Figure 2A-2C Blood pump catheter shown and described. For some applications (not shown), the blood pump catheter includes more than two tubes 76 disposed at respective locations about the longitudinal axis of the blood pump catheter and extending from tube 74 to a suprarenal location while bypassing blood pump 24.

[0180] Reference now Figure 2E , Figure 2E is a schematic diagram of a blood pump catheter 70 placed in the vena cava 22 of a subject according to some applications of the present invention, the blood pump having a non-axisymmetric outflow tube 76 and a non-axisymmetric blood pump 24. Figure 2F , Figure 2F According to some applications of the present invention, in the absence of a subject's anatomical structure, Figure 2E Schematic diagram of the blood pump catheter. Figure 2D As described, for some applications, the blood pump catheter includes only a single tube 76 that is disposed on one side of the longitudinal axis of the blood pump catheter and extends from tube 74 to the suprarenal position while bypassing the blood pump 24. For some such applications, the blood pump 24 is disposed on opposite sides of the longitudinal axis of the blood pump catheter in a non-axisymmetric orientation, as shown. In other aspects, such as Figure 2E and Figure 2F The blood pump catheter 70 shown is generally similar to that of reference Figure 2A-2D A blood pump catheter as shown and described.

[0181] For some applications, refer to Figure 2A-2E The described technique is performed in the absence of a blood pump 24. That is, in the absence of a blood pump 24, the blood flow in the region of the vena cava adjacent to the junction of the vena cava with the renal veins is partitioned into a compartment 82 that is separated from the infrarenal vena cava blood flow 84 and the suprarenal vena cava blood flow 86. For some such applications, the blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 is then passively controlled (e.g., as described above) without affecting the blood flow from the renal veins to the suprarenal vena cava blood flow 86. Alternatively or additionally, the blood flow from the renal veins to the suprarenal vena cava blood flow 86 is passively controlled without affecting the blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86.

[0182] refer to Figure 2A-2EIt should be noted that the scope of the present invention includes the application of similar devices and methods to any venous system of a subject, the venous system including branch veins that flow into a main vein. For example, similar techniques can be applied to the junction of the hepatic vein and the vena cava. Typically, this method includes separating the blood flow in the region of the main vein adjacent to the junction of the main vein and the branch vein from the blood flow upstream and downstream of the main vein, using a pump to pump blood from the region of the main vein adjacent to the junction of the vein and the branch vein to a location downstream of the branch vein in the main vein, and by directing the blood to bypass the pump, allowing the subject's blood to flow from a location in the main vein upstream of the branch vein to a location in the main vein downstream of the branch vein without being pumped by the pump. For some applications, a substantially similar device and method is used at the junction of the vein and the lymphatic vessel in the subclavian vein or jugular vein. For some such applications, the blood pump catheter 70 is configured, with necessary modifications, to increase the flow of lymphatic fluid from the lymphatic catheter into the vein. In general, the scope of some applications of the present invention also includes devices and methods for the venous system of a subject, the venous system including branch vessels (e.g., lymphatic vessels) that flow into the vein. Typically, the method includes separating flow within a region of the vein adjacent to the junction of the vein with a branch vessel from blood flow upstream and downstream of the region within the vein, using a pump to pump blood from the region of the vein adjacent to the junction of the vein with the branch vessel to a location within the vein downstream of the region, and allowing the subject's blood to flow from a location within the vein upstream of the branch vessel to a location within the vein downstream of the branch vessel without being pumped by the pump by directing the blood to bypass the pump.

[0183] For some applications, the method includes at least partially blocking blood flow through the vein by placing a downstream obstruction element, such as body of material 36, at a downstream position downstream of the connection between the vein and the branch vessel, pumping blood from a region of the vein adjacent to the connection between the vein and the branch vessel using a pump and pumping the blood through the downstream obstruction element, directing the upstream venous blood flow from an upstream position upstream of the connection between the vein and the branch vessel to downstream of the obstruction element without pumping the upstream venous blood flow through the pump by directing the upstream venous blood flow around the pump. Typically, the method is performed using a blood pump catheter, such as blood pump catheter 70, which includes body of material 36 configured to be placed at a downstream position downstream of the connection between the vein and the branch vessel and at least partially blocking blood flow through the vein at the downstream position, the body of material defining a blood outlet opening 31. Blood pump 24 is typically configured to pump blood from a region of the vein adjacent to the connection between the vein and the branch vessel through the blood outlet opening defined by the body of material. The blood flow path 60 typically passes between a path inlet opening 61 disposed at an upstream position upstream of the connection between the vein and the branch vessel and a path outlet opening 63 leading to a downstream side of the body of material 36. For some applications, the blood flow path includes a funnel 72 and one or more tubes (e.g., tube 74 and tube 76). The funnel 72 is configured to be disposed at an upstream position upstream of the connection between the vein and the branch vessel, and the one or more tubes 74, 76 are configured to extend from the funnel to the downstream side of the body of material. The funnel and the one or more tubes (or alternative blood flow paths) are configured to direct the upstream venous blood flow from the upstream position to the downstream of the body of material without the upstream venous blood flow being pumped by a pump. Typically, the funnel 72 defines a wide end 85 and a narrow end 87, as shown in FIG. Figure 2A The wide end of the funnel typically defines an inlet opening into the blood flow path, while the narrow end of the funnel leads to one or more tubes (eg, tube 74 and tube 76).

[0184] Reference now Figure 3A , Figure 3B , Figure 3C , Figure 3D , Figure 3E , Figure 3F , Figure 3G and Figure 3H , which is a schematic diagram of a blood pump catheter 70 according to other applications of the present invention. Figure 3A-3H The blood pump catheter 70 shown and described is generally similar to that of the Figure 2A-2F The blood pump catheter described herein, except for the differences described below. It should be noted that Figure 3A-3H As shown, the blood pump catheter has Figure 2E and Figure 2FThe design shown is substantially similar to the design shown (where (a) only a single tube 76 is disposed on one side of the longitudinal axis of the blood pump conduit and extends from tube 74 to a suprarenal location while bypassing blood pump 24, and (b) blood pump 24 is disposed on the opposite side of the longitudinal axis of the blood pump conduit in a non-axisymmetric orientation). However, the scope of the present application includes, mutatis mutandis, the referenced Figure 3A-3H The features of the blood pump catheter 70 described above are similar to those of the Figure 2A-2D Any of the described designs of blood pump catheter 70 may be combined.

[0185] Reference now Figure 3A For some applications, the elongated tube 109 extends from the frame 34 to the subject's pulmonary artery 110, such that the blood outlet opening 31 is disposed in the pulmonary artery. (It should be noted that for some applications, the body of material 36 defines a blood outlet opening, and the elongated tube extends from the blood outlet opening defined by the body of material to the blood outlet opening disposed in the pulmonary artery.) The tube 109 is typically made of a body of material that is impermeable to blood. For example, the tube 109 may include polyurethane, polyester, and / or silicone. Alternatively or additionally, the tube is made of polyethylene terephthalate (PET) and / or polyether block amide (e.g., ). The blood pump catheter is configured to pump blood directly from compartment 82 into the subject's pulmonary artery. In this way, the blood pump catheter reduces renal vein pressure without increasing the preload of the subject's right atrium. Figure 2A-2F As described above, typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 bypasses the elongated tube. Typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 occurs passively by flowing through the blood flow path 60 (e.g., funnel 72, tube 74, and tube 76).

[0186] refer to Figure 3B For some applications, elongated tube 109 includes a portion 111 disposed within suprarenal vena cava blood flow 86, and portion 111 defines a suprarenal blood inlet opening 112. Impeller 50 and frame 34 are typically disposed downstream of the suprarenal blood inlet opening, and in addition to pumping blood from compartment 82 into elongated tube 109, impeller 50 is configured to pump blood from the suprarenal vena cava blood flow into elongated tube 109 via blood inlet opening 112. As described in reference Figure 3A As depicted, typically, an elongated tube 109 extends from the frame 34 to a pulmonary artery 110 of the subject such that the blood outlet opening 31 is disposed in the pulmonary artery. Figure 3BThe blood pump catheter 70 of the illustrated configuration is typically configured to reduce renal venous pressure (by pumping blood from compartment 82) and to assist the subject's right heart function by pumping blood from the suprarenal vena cava blood stream to the pulmonary artery. Figure 2A-2F As described above, typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 bypasses the elongated tube. Typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 occurs passively by flowing through the blood flow path 60 (e.g., funnel 72, tube 74, and tube 76).

[0187] refer to Figure 3C For some applications, in addition to using the blood pump catheter 70 to reduce renal vein pressure (and alternatively, as described in reference Figure 3B As described, for assisting right heart function), the left ventricular assist device 113 is deployed in the left ventricle 114 of the subject to assist the left heart function of the subject. For some applications, the left ventricular assist device is a left ventricular assist device as described in Tuval's US16 / 750,354 (filed on January 23, 2020, entitled "Distal tip element for a ventricular assist device"), Tuval's US2019 / 0209758, and / or Tuval's US2019 / 0175806, all of which are incorporated herein by reference. For some applications, the left ventricular assist device includes a Left ventricular assist devices such as Impella manufactured by Impella Impella and or / Impella It should be noted that although the left ventricular assist device 113 is shown with Figure 3B The examples of blood pump catheter 70 shown are used in combination, but the scope of the present application includes the use of left ventricular assist device 113 in combination with any of the examples of blood pump catheter 70 described herein.

[0188] Reference now Figure 3D For some applications, instead of the impeller 50 and frame 34, an elongated blood pump tube 104 (which typically includes the impeller) is disposed within the blood outlet opening in the cover material body 36. Typically, the cover material body 36 and / or the liner 39 ( Figure 7 ) is sealingly connected to the outer surface of the elongated blood pump tube. For example, the elongated blood pump tube may include Impella made in Massachusetts, USA Typically, the elongated blood pump tube includes a blood inlet region 105 (disposed in the upstream portion of the elongated blood pump tube), the blood inlet region 105 being disposed relative to the cover material body 36 and / or the liner 39 ( Figure 7 ). The impeller 106 (which is typically disposed distally and immediately adjacent to the blood inlet region) pumps blood from the compartment 82 into the blood inlet region, through the elongated blood pump tube, and out of the blood outlet region 107 (disposed in the downstream portion of the elongated blood pump tube). Figure 3A In the example shown, the blood outlet region is arranged in the suprarenal vena cava so that the blood is pumped into the suprarenal vena cava blood flow 86. Figure 2A-2F As described above, typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 bypasses the elongated blood pump tube. Typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 occurs passively by flowing through the blood flow path 60 (e.g., funnel 72, tube 74, and tube 76).

[0189] refer to Figure 3E For some applications, the elongated blood pump tube 104 is configured such that the blood inlet region 105 and the impeller 106 are disposed within the suprarenal vena cava. For some such applications, a reinforcing tube 115 (e.g., a tube made of a polymer supported by a shape memory material (e.g., nitinol) frame and / or a shape memory material (e.g., nitinol) braid) is provided from the covering material body 36 and / or the liner 39 ( Figure 7 ) extends from the outlet opening of the covering material body 36 to the blood inlet region of the elongated blood pump tube and forms a seal between the covering material body 36 and / or the liner 39 and the blood inlet region of the elongated blood pump tube. In this manner, the impeller 106 draws blood from the compartment 82 to the blood inlet region 105. Typically, the elongated blood pump tube extends from the blood inlet region to the blood outlet region 107, which is disposed in the pulmonary artery 110 of the subject. In some alternative applications (not shown), the elongated blood pump tube itself extends from upstream of the covering material body 36 to the pulmonary artery 110 (i.e., in the absence of the reinforcing tube 115). The elongated blood pump tube is configured to pump blood from the compartment 82 into the pulmonary artery of the subject. In this manner, the blood pump catheter 70 reduces the renal vein pressure without increasing the preload on the right atrium of the subject. According to Figure 2A-2F As described above, typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 bypasses the elongated blood pump tube. Typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 occurs passively by flowing through the blood flow path 60 (e.g., funnel 72, tube 74, and tube 76).

[0190] Reference now Figure 3FFor some applications, the reinforcing tube 115 defines a blood inlet opening 117, which is disposed in the suprarenal vena cava. The impeller 106 and the blood inlet region 105 are typically disposed downstream of the blood inlet opening 117, and in addition to pumping blood into the elongated blood pump tube 104, the impeller is also configured to pump blood from the suprarenal vena cava blood flow into the elongated blood pump tube 104 via the blood inlet opening 117. As described in reference Figure 3E As depicted, typically, an elongated blood pump tube 104 extends from the suprarenal vena cava to a subject's pulmonary artery 110 such that a blood outlet region 107 is disposed in the pulmonary artery. Figure 3F The blood pump catheter 70 of the illustrated configuration is typically configured to reduce renal venous pressure (by pumping blood from compartment 82) and to assist the subject's right heart function by pumping blood from the suprarenal vena cava blood stream to the pulmonary artery. Figure 2A-2F As described above, typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 bypasses the elongated blood pump tube. Typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 occurs passively by flowing through the blood flow path 60 (e.g., funnel 72, tube 74, and tube 76).

[0191] Reference now Figure 3G For some applications, blood inlet opening 117 is disposed in a right ventricle 119 of a subject, and impeller 106 and blood inlet region 105 are disposed downstream of the blood inlet opening. In addition to pumping blood into elongated blood pump tube 104, impeller 106 is configured to pump blood from the right ventricle into elongated blood pump tube 104 via blood inlet opening 117. Typically, elongated blood pump tube 104 extends from the right ventricle to a pulmonary artery 110 of the subject, such that blood outlet region 107 is disposed in the pulmonary artery. Figure 3G The blood pump catheter 70 constructed in is typically configured to reduce renal vein pressure (by pumping blood from compartment 82) and to assist the subject's right heart function by pumping blood from the right ventricle to the pulmonary artery. Figure 2A-2F As described above, typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 bypasses the elongated blood pump tube. Typically, blood flow from the infrarenal vena cava blood flow 84 to the suprarenal vena cava blood flow 86 occurs passively by flowing through the blood flow path 60 (e.g., funnel 72, tube 74, and tube 76).

[0192] Reference now Figure 3H For some applications, blood pump conduit 70 includes an elongated blood pump tube 104 (e.g., according to reference Figure 3D-Figure 3G1 ), and the blood pump catheter is used in conjunction with a left ventricular assist device 113, which is deployed in the subject's left ventricle 114 to assist the subject's left ventricular function (e.g., as described above with reference to Figure 3C For some applications, the left ventricular assist device is a left ventricular assist device as described in US 16 / 750,354 to Tuval (filed January 23, 2020, entitled “Distal tip element for a ventricular assist device”), US 2019 / 0209758 to Tuval, and / or US 2019 / 0175806 to Tuval, all of which are incorporated herein by reference. For some applications, the left ventricular assist device includes a Left ventricular assist devices such as Impella manufactured by Impella Impella and / or Impella It should be noted that although the left ventricular assist device 113 is shown with Figure 3F The examples of blood pump catheter 70 shown are used in combination, but the scope of the present application includes the use of left ventricular assist device 113 in combination with any of the examples of blood pump catheter 70 described herein.

[0193] Reference now Figure 4A and Figure 4B , Figure 4A and Figure 4B FIG. 1 is a schematic diagram of a blood pump catheter 90 placed within a subject's descending aorta 80 near a renal artery 94 according to some applications of the present invention. The structure of the blood pump catheter 90 is generally similar to that described above with reference to FIG. Figure 2A-2F The structure of the blood pump catheter 70 is depicted. However, the blood pump 24 of the blood pump catheter 90 is typically configured to pump blood in an upstream direction to enhance perfusion of an organ, such as the kidneys, as described in further detail below.

[0194] Typically, the blood pump conduit 90 includes the blood pump 24, which typically includes an impeller housing 26 and an impeller 50, all of which are generally as described above. The impeller housing 26 (e.g., the frame 34 of the housing) is typically used to separate the inner wall of the aorta from the impeller so that the aorta is not damaged by the impeller and the impeller is not deformed due to pressure from the inner wall of the aorta. More typically, an axial shaft 92 (e.g., Figure 7The impeller housing is supported by radial bearings 116, 118 respectively disposed at the proximal and distal ends of the impeller housing.

[0195] For some such applications, the blood pump support frame 32 is disposed upstream of the impeller housing 26 and is configured to contact the inner wall of the aorta. The blood pump support frame 32 is configured to align the longitudinal axis of the impeller housing 26, and subsequently the longitudinal axis of the impeller 50, with the local longitudinal axis of the aorta by contacting the inner wall of the aorta. (It should be noted that for some applications, the blood pump support frame may not completely align the longitudinal axis of the impeller with the local longitudinal axis of the aorta. However, typically, the blood pump support frame maintains the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the aorta better than the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the aorta in the absence of the blood pump support frame.) Typically, other things being equal, the greater the effectiveness of the impeller 50 in pumping blood, the better the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the aorta. As described above, typically, even if the longitudinal axis of the impeller is slightly misaligned with the local longitudinal axis of the blood vessel in which it is placed (e.g., such as Figure 2E As a result, however, the impeller will still effectively pump the blood.

[0196] For some applications, the impeller housing 26 includes a frame 34 (e.g., a rigid or semi-rigid frame) made of a shape memory element (e.g., nitinol) that is at least partially covered with a body of material 36 (e.g., a body of material that is impermeable to blood, such as polyester, polyurethane, and / or a different polymer). Typically, for such applications, the rigidity of the frame 34 is sufficient so that pressure exerted on the frame 34 by the inner wall of the aorta does not deform the frame. Typically, the body of material 36 extends from the impeller housing to the blood pump support frame 32, thereby contacting the vessel wall and occluding the vessel in the region of the vessel surrounding the impeller and / or upstream of the impeller. The body of material typically defines a hole therethrough at a distal portion of the impeller housing. The hole is configured to serve as a blood inlet opening 98 during pumping of blood through the impeller. For some applications, a portion of the impeller housing is covered (i.e., lined) on the inner side of the impeller housing by a liner 39, for example, as described below with reference to Figure 7 For some such applications, the liner of the impeller housing at least partially overlaps body of material 36. For some applications, the liner extends the blood inlet defined by body of material 36.

[0197] Typically, the drive cable 78 is disposed within the outer tube 77 of the blood pump catheter 90. (For example, Fig. 8A Typically, the drive cable extends from a motor 79 disposed outside the subject's body to an axial shaft 92 (at Figure 71 ), the impeller is disposed on an axial shaft 92. The motor transmits rotational motion to the axial shaft (and thus to the impeller) via a drive cable. Typically, the motor is controlled by a computer processor 10. For some applications, the motor is controlled based on blood pressure measurements performed by a pressure sensor 75.

[0198] For some applications, the blood pump catheter also includes a blood flow path 60. For some applications, the blood flow path 60 includes a funnel 72 extending into a tube 74. The funnel is configured to be placed upstream of the connection of the aorta to the subject's renal arteries, and is configured to direct all blood flow from the suprarenal aorta into the tube 74. The tube 74 then directs the blood flow from the suprarenal aortic location to the infrarenal aortic location, in such a way that the blood flows to the infrarenal location by bypassing the blood pump 24 (i.e., not being pumped by the blood pump 24). For example, one or more tubes 76 may extend from the tube 74 to the infrarenal location while bypassing the blood pump. As shown in FIG. Figure 4A As indicated by the blood flow arrows in , blood thus flows from the suprarenal aorta to the infrarenal aorta without being pumped by the blood pump 24. In contrast, blood is pumped from the infrarenal aorta to the renal artery 94 by the blood pump 24, as shown in FIG. Figure 4B Typically, pumping blood into the renal arteries enhances renal perfusion.

[0199] In this manner, by deploying the blood pump catheter 90, the blood flow in the region of the aorta adjacent to the junction of the aorta with the renal arteries is partitioned into a compartment 97 that is separated from the suprarenal aortic blood flow 95 and the infrarenal aortic blood flow 99. Blood flow from the suprarenal aortic blood flow 95 to the infrarenal aortic blood flow 99 occurs passively (e.g., by flowing through the blood flow path 60). Blood is actively pumped from the infrarenal aortic blood flow 99 to the compartment 97 using a blood pump.

[0200] It should be noted that the specific examples of the configurations of funnel 72, tube 74, and tube 76 are shown by way of example, and the scope of the present application includes, mutatis mutandis, any other configuration of the blood flow path to direct blood from the suprarenal aortic blood flow to the infrarenal aortic blood flow without pumping through blood pump 24. For some applications, funnel 72, tube 74, and tube 76 comprise respective portions of a single continuous blood flow path. The blood flow path typically passes between a path inlet opening 61 and a path outlet opening 63, wherein the path inlet opening 61 is disposed at an upstream position upstream of the connection of the aorta to the renal arteries, and the path outlet opening 63 opens to the downstream side of the body of material 36. Typically, funnel 72 defines a wide end 85 and a narrow end 87. The wide end of the funnel typically defines an inlet opening into the blood flow path, while the narrow end of the funnel opens into one or more tubes (e.g., tube 74 and tube 76).

[0201] Typically, blood flow from the suprarenal aortic blood stream 95 to the infrarenal aortic blood stream 99 is substantially unchanged relative to blood flow from the suprarenal aortic blood stream 95 to the infrarenal aortic blood stream 99 in the absence of a blood pump conduit. For some applications, the diameter of one or more portions of the blood flow path is controlled to control blood flow from the suprarenal aortic blood stream 95 to the infrarenal aortic blood stream 99. For example, the diameter of one or more portions of the blood flow path (e.g., funnel 72, tube 74, and / or tube 76) may be adjusted (e.g., using an expandable / contractible member disposed inside or outside of one of these portions). In this manner, for example, blood supply to the lower body may be controlled.

[0202] refer to Figure 4A-4BIt should be noted that the scope of the present invention includes the application of similar devices and methods to any arterial system of a subject, including the aorta that flows into a branch artery (which typically supplies an organ). For example, similar techniques can be applied to the junction of the aorta with the hepatic artery (which supplies the liver). Typically, this method includes separating the blood flow in the region of the aorta adjacent to the junction of the aorta with the branch artery from the blood flow upstream and downstream of the aorta, enhancing the perfusion of the organ by using a pump to pump blood from the aorta to the region of the aorta adjacent to the junction of the aorta with the branch artery, and allowing the subject's blood to flow from a location in the aorta upstream of the branch artery to a location in the aorta downstream of the branch artery without being pumped by the pump by directing blood to bypass the pump. For some applications, such a method includes at least partially blocking blood flow through the aorta by placing a downstream obstruction element (e.g., body of material 36) at a downstream position downstream of the junction of the aorta with the branch arteries, enhancing organ perfusion by pumping blood from a region of the aorta adjacent to the junction of the aorta with the branch arteries through the downstream obstruction element using a pump (e.g., blood pump 24), and directing upstream aortic blood flow from an upstream position upstream of the junction of the aorta with the branch arteries to downstream of the obstruction element without the upstream aortic blood flow being pumped by the pump to bypass the pump. Typically, a blood pump catheter such as blood pump catheter 90 is used, the blood pump catheter including body of material 36 configured to be placed at a downstream position downstream of the junction of the aorta with the branch arteries and at least partially blocking blood flow through the aorta at the downstream position, the body of material defining a blood inlet opening 98. Blood pump 24 is typically configured to pump blood from the aorta to a region of the aorta adjacent to the junction of the aorta with the branch arteries through the blood inlet opening. The blood flow path 60 typically passes between a path inlet opening 61 and a path outlet opening 63, wherein the path inlet opening 61 is disposed at an upstream position upstream of the connection between the aorta and the branch artery, and the path outlet opening 63 leads to the downstream side of the material body 36. For some applications, the blood flow path includes a funnel 72 and one or more tubes (e.g., tube 74 and tube 76). The funnel 72 is configured to be disposed at an upstream position upstream of the connection between the aorta and the branch artery, and one or more tubes 74, 76 (or alternative blood flow paths) are configured to extend from the funnel to the downstream side of the material body. The funnel and the one or more tubes (or alternative blood flow paths) are typically configured to guide the upstream aortic blood flow from the upstream position to the downstream of the material body, while the upstream aortic blood flow is not pumped by the pump. Typically, the funnel 72 defines a wide end 85 and a narrow end 87. The wide end of the funnel typically defines an inlet opening into the blood flow path, while the narrow end of the funnel leads to one or more tubes (e.g., tube 74 and tube 76).

[0203] Reference now Figure 5A-Figure 5B , Figure 5A-Figure 5B 8 is a schematic diagram of a blood pump catheter 20 placed within a descending aorta 80 of a subject according to some applications of the present invention. Typically, the blood pump catheter 20 is substantially as described above, and includes a blood pump 24, which typically includes an impeller housing 26 and an impeller 50, all of which are substantially as described above. The impeller housing 26 (e.g., the frame 34 of the housing) typically acts to separate the inner wall of the aorta from the impeller so that the aorta is not damaged by the impeller and the impeller is not deformed due to pressure from the inner wall of the aorta. More typically, an axial shaft 92 (e.g., a housing frame 34) passes through the impeller. Figure 7 The impeller housing is supported by radial bearings 116, 118 respectively disposed at the proximal and distal ends of the impeller housing.

[0204] For some such applications, the blood pump support frame 32 is disposed upstream of the impeller housing 26 and is configured to contact the inner wall of the aorta. The blood pump support frame 32 is configured to align the longitudinal axis of the impeller housing 26, and subsequently the longitudinal axis of the impeller 50, with the local longitudinal axis of the aorta by contacting the inner wall of the aorta. (It should be noted that for some applications, the blood pump support frame may not completely align the longitudinal axis of the impeller with the local longitudinal axis of the aorta. However, typically, the blood pump support frame maintains the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the aorta better than it would have in the absence of the blood pump support frame.) Typically, all other things being equal, the greater the efficiency with which the impeller 50 pumps blood, the better the alignment of the longitudinal axis of the impeller with the local longitudinal axis of the aorta.

[0205] For some applications, the impeller housing 26 includes a frame 34 (e.g., a rigid or semi-rigid frame) made of a shape memory element (e.g., nitinol) that is at least partially covered with a body of material 36 (e.g., a body of material that is impermeable to blood, such as polyester, polyurethane, and / or a different polymer). Typically, for such applications, the rigidity of the frame 34 is sufficiently large that pressure exerted on the frame 34 by the inner wall of the aorta does not deform the frame 34. Typically, the body of material 36 extends from the impeller housing to the blood pump support frame 32 and then to the impeller housing, thereby contacting the vessel wall and blocking the vessel in the region of the vessel surrounding the impeller and / or upstream of the impeller. The body of material typically defines a hole therethrough at a distal portion of the impeller housing. The body of material is configured to block the backflow of blood around the outside of the impeller, but to allow antegrade blood flow in the central region of the vessel near the impeller through the hole that serves as the blood outlet opening 31. For some applications, a portion of the impeller housing is covered (i.e., lined) on the inside of the impeller housing by a liner 39, for example, as described below with reference to Figure 7 For some such applications, the liner of the impeller housing at least partially overlaps body of material 36. For some applications, the liner extends the blood outlet opening defined by body of material 36.

[0206] Typically, the drive cable 78 is disposed within the outer tube 77 of the blood pump catheter 90. (For example, Fig. 8A Typically, the drive cable extends from a motor 79 disposed outside the subject's body to an axial shaft 92 (eg, Figure 7 92 ), the impeller is disposed on an axial shaft 92. The motor transmits rotational motion to the axial shaft (and thereby to the impeller) via a drive cable. Typically, the motor is controlled by a computer processor 10. For some applications, the motor is controlled based on blood pressure measurements performed by a pressure sensor 75. The body of covering material 36 effectively separates the descending aorta into two compartments, and the blood pump pumps blood from the upstream compartment to the downstream compartment. In this manner, the blood pump typically expands aortic blood flow and / or reduces left ventricular afterload.

[0207] refer to Figure 5A For some applications, the blood pump is inserted into the descending aorta via an artery below the descending aorta (such as the femoral artery). Alternatively or additionally, the blood pump is inserted into the descending aorta via an artery above the descending aorta (e.g., via the radial artery or the subclavian artery), such as Figure 5B For some applications, the blood pump catheter is inserted, mutatis mutandis, into the subject's aortic arch rather than the descending aorta.

[0208] For some applications, the impeller 50, impeller housing 26, frame 34, and / or other components of the blood pump catheter described herein have features similar to components described in Tuval's US 16 / 750,354 (filed January 23, 2020, entitled "Distal tip element for a ventricular assist device"), Tuval's US 2019 / 0209758, Tuval's US 2019 / 0239998, and / or Tuval's US 2019 / 0175806, all of which are incorporated herein by reference. For example, the following references Figures 6A-8C Describe some of these characteristics.

[0209] Reference now Figure 6A-6C , Figure 6A-6C is a schematic diagram of an impeller 50 or a portion thereof according to some applications of the present invention. Typically, the impeller includes at least one outer helical elongated element 52 that is wound around a central axial spring 54 such that the helix defined by the helical elongated element is coaxial with the central axial spring. Typically, the impeller includes two or more helical elongated elements (e.g., three helical elongated elements, such as Figure 6A-6C For some applications, the helical elongated element and the central axial spring are made of a shape memory material, for example, a shape memory alloy such as Nitinol. Typically, each of the helical elongated element and the central axial spring supports a membrane 56 of a body of material (e.g., an elastomer such as polyurethane and / or silicone) located therebetween. For some applications, the membrane of the body of material includes a sheet of Nitinol embedded therein, for the purpose of, for example, reinforcing the membrane of the body of material. For purposes of illustration, the membrane of the body of material is shown in FIG. Fig. 6A The impeller is shown without a material body. Figure 6B and Figure 6C A view of an impeller is shown in each case, wherein the body of material is supported between the helical elongated element and the spring.

[0210] Each of the helical elongated elements together with the membrane extending from the helical elongated element to the spring defines a blade of a corresponding impeller, wherein the helical elongated element defines the outer edge of the blade and the axial spring defines the axis of the impeller. Typically, the membrane of the body of material extends along and covers the spring. For some applications, suture 53 (e.g., polyester suture, in Figure 6B and Figure 6C) is wrapped around a helical elongate element, for example, as described in US 2016 / 0022890 to Schwammenthal, which is incorporated herein by reference. Typically, the suture is configured to promote bonding between a membrane of a body of material (typically an elastomer, such as polyurethane or silicone) and a helical elongate element (typically a shape memory alloy, such as nitinol). For some applications, a suture (e.g., a polyester suture, not shown) is wrapped around spring 54. Typically, the suture is configured to promote bonding between a membrane of a body of material (typically an elastomer, such as polyurethane or silicone) and a spring (typically a shape memory alloy, such as nitinol).

[0211] Figure 6C Enlarged views A and B of 5000 show two alternative ways in which the suture is tied around the helical elongated member 52. For some applications, the suture is tied around the outer surface of the helical elongated member, as shown in enlarged view A. Alternatively, the helical elongated member defines a groove 48 on its outer surface, and the suture is embedded in the groove, as shown in enlarged view B. By embedding the suture in the groove, the suture typically does not add to the outer contour of the impeller, and the outer contour of the impeller is defined by the outer surface of the helical elongated member.

[0212] Typically, the proximal ends of the spring 54 and the helical elongated element 52 extend from a proximal bushing (i.e., sleeve bearing) 64 of the impeller such that the proximal ends of the spring 54 and the helical elongated element 52 are disposed at similar radial distances from each other to the longitudinal axis of the impeller. Similarly, typically, the distal ends of the spring 54 and the helical elongated element 52 extend from a distal bushing 58 of the impeller such that the distal ends of the spring 54 and the helical elongated element 52 are disposed at similar radial distances from each other to the longitudinal axis of the impeller. Typically, the spring 54 and the proximal bushing 64 and the distal bushing 58 of the impeller define an inner cavity 62 (e.g., Figure 6C shown).

[0213] Reference now Figure 7 , Figure 7 is a schematic diagram of an impeller 50 disposed within a frame 34 of a blood pump catheter 20, 70, or 90 according to some applications of the present invention. For some applications, the frame 34 is lined with a liner 39 within at least a portion of the frame. The liner partially overlaps or completely overlaps the body of cover material 36 on the lined portion of the frame, depending on the respective application. Figure 7 In the application shown, the liner is lined (ie, covers) the inside of the cylindrical portion 38 of the frame, and the cylindrical portion of the frame is not covered by the body of covering material 36. For this application, the liner extends beyond the blood inlet opening or the blood outlet opening of the blood pump.

[0214] like Figure 7As shown, there is typically a gap G between the outer edge of the impeller 50 and the liner 39, even at a position where the span of the impeller is at its maximum. For some applications, it is desirable that the gap between the outer edge of the impeller blades and the liner 39 be relatively small so that the impeller can effectively pump blood. However, it is also desirable that the gap between the outer edge of the impeller blades and the liner 39 remain substantially constant throughout the rotation of the impeller within the frame 34, for example, to reduce the risk of hemolysis.

[0215] For some applications, when both the impeller and the frame 34 are arranged in the non-radially constrained configuration, the gap G between the outer edge of the impeller and the liner 39 is greater than 0.05 mm (e.g., greater than 0.1 mm) and / or less than 1 mm (e.g., less than 0.4 mm), for example, 0.05 mm-1 mm, or 0.1 mm-0.4 mm, at the position where the span of the impeller is at its maximum. For some applications, when the impeller is arranged in its non-radially constrained configuration, the outer diameter of the impeller is greater than 7 mm (e.g., greater than 8 mm), and / or less than 10 mm (e.g., less than 9 mm), for example, 7 mm-10 mm, or 8 mm-9 mm, at the position where the outer diameter of the impeller is at its maximum. For some applications, when the frame 34 is disposed in its non-radially constrained configuration, the inner diameter of the cylindrical portion 38 of the frame 34 (measured from the inner side of the liner 39 on one side of the frame to the inner side of the liner on the opposite side of the frame) is greater than 7.5 mm (e.g., greater than 8.5 mm), and / or less than 10.5 mm (e.g., less than 9.5 mm), for example, 7.5 mm-10.5 mm, or 8.5 mm-9.5 mm. For some applications, when the frame is disposed in its non-radially constrained configuration, the outer diameter of the cylindrical portion 38 of the frame 34 is greater than 8 mm (e.g., greater than 9 mm), and / or less than 13 mm (e.g., less than 12 mm), for example, 8 mm-13 mm, or 9 mm-12 mm.

[0216] Typically, axial shaft 92 passes through the axis of impeller 50 via the inner cavity 62 of the impeller. More typically, the axial shaft is rigid, such as a rigid tube. For some applications, the proximal bushing 64 of the impeller is coupled to the shaft such that the axial position of the proximal bushing relative to the shaft is fixed, and the distal bushing 58 of the impeller is slidable relative to the shaft. The axial shaft itself is radially stabilized via proximal radial bearings 116 and distal radial bearings 118. (It should be noted that in Figure 7 , the distal radial bearing 118 is not visible because the distal radial bearing 118 is disposed below the distal tip element 108. However, in other figures (e.g. Figures 1A-1C , Figure 2A-2E and Figure 4A-4B) the distal radial bearing is visible. Subsequently, by passing through the inner cavity 62 defined by the impeller, the axial shaft radially stabilizes the impeller relative to the inner surface of the frame 34, so that even during rotation of the impeller, a relatively small gap (e.g., as described above) between the outer edges of the blades of the impeller and the inner surface of the frame 34 is maintained.

[0217] Reference again Figure 6A-6C For some applications, the impeller includes a plurality of elongated elements 67 extending radially from the central axial spring 54 to the outer helical elongated element 52. The elongated elements are typically flexible but substantially inextensible along an axis defined by the elongated elements. Additionally, each elongated element is typically configured to not apply a force to the helical elongated element unless a force acting on the impeller causes the helical elongated element to move radially outward such that (in the absence of the elongated elements) the spacing between the helical elongated element and the central axial spring would be greater than the length of the elongated element. For example, the elongated element may include a string (such as polyester and / or another polymer or natural material containing fibers) and / or a wire (such as nitinol wire and / or a wire made of a different alloy or metal).

[0218] For some applications, the elongated element 67 maintains the spiral elongated element (which defines the outer edge of the blades of the impeller) within a given distance relative to the central axial spring. In this way, the elongated element is configured to prevent the outer edge of the impeller from being pushed radially outward due to the force exerted on the impeller during the rotation of the impeller. The elongated element is thereby configured to maintain a gap between the outer edge of the blades of the impeller and the lining 39 of the frame 34 during the rotation of the impeller. Typically, more than one (e.g., more than two) and / or less than eight (e.g., less than four) elongated elements 67 are used in the impeller, wherein each elongated element is typically doubled (i.e., extending radially from the central axial spring 54 to the outer spiral elongated element 52, and then returning from the spiral elongated element to the central axial spring). For some applications, multiple elongated elements are formed from a single piece of string or wire, each of the multiple elongated elements extending from the spring to a corresponding spiral elongated element and returning to the spring, as described in further detail below.

[0219] For some applications, the impeller is manufactured in the following manner. The proximal bushing 64, the distal bushing 58 and the spiral elongated element 52 are cut from a tube of a shape memory material such as nitinol. The cutting of the tube and the shaping of the shape memory material are typically performed such that the spiral elongated element is defined by the shape memory material, for example, using a technique substantially similar to that described in US2016 / 0022890 of Schwammenthal. Typically, the spring 54 is inserted into the cut and shaped tube so that the spring extends from at least the proximal bushing to the distal bushing along the length of the tube. For some applications, the spring is inserted into the cut and shaped tube when the spring is in an axially compressed state, and the spring is configured to maintain a proper position relative to the tube by applying a radial force on the proximal bushing and the distal bushing. Alternatively or additionally, some portions of the spring are welded to the proximal bushing and the distal bushing. For some applications, the spring is cut from a tube of a shape memory material (such as nitinol). For some such applications, the spring is constructed so that when the spring is arranged in a non-radially constrained configuration (which the spring is typically arranged into during operation of the impeller), there is substantially no gap between a winding of the spring and a winding adjacent to the winding.

[0220] For some applications, after the spring 54 is inserted into the cut and shaped tube, the elongated element 67 as described above is placed so as to extend between the spring and one or more spiral elongated elements (e.g., in the following manner). A mandrel (e.g., a polyetheretherketone (PEEK) and / or polytetrafluoroethylene (PTFE) mandrel) is inserted through the lumen defined by the spring and the bushing. The string or line is then threaded so that the string or line (a) passes from the mandrel to the first spiral elongated element, (b) returns from the first spiral elongated element to the mandrel, (c) surrounds the mandrel and passes to the second spiral elongated element, (d) returns from the second spiral elongated element to the mandrel, and so on. Once the string or line has been threaded from the mandrel to each spiral elongated element and back again, the ends of the string or line are interconnected, for example, by tying the ends to each other. For some applications, suture 53 (e.g., polyester suture) is wrapped around the helical elongated element to facilitate bonding between the membrane of the material body (typically an elastomer, such as polyurethane or silicone) and the helical elongated element (typically a shape memory alloy, such as Nitinol) in subsequent stages of impeller manufacturing. For some applications, suture (e.g., polyester suture, not shown) is wrapped around spring 54. Typically, the suture is configured to facilitate bonding between the membrane of the material body (typically an elastomer, such as polyurethane or silicone) and the spring (typically a shape memory alloy, such as Nitinol) in subsequent stages of impeller manufacturing.

[0221] Typically, at this stage, Fig. 6AAs shown in FIG. 5 , the structure 59 has been assembled. The structure includes a cut and shaped tube defining the proximal and distal bushings, the helical elongate element, and the spring (and, optionally, the elongate element and the suture). The structure is immersed in a body of material defining the membrane 56. For some applications, the assembled structure is immersed in the body of material with a mandrel disposed through the lumen defined by the spring and bushing, although it should be noted that the mandrel is not inserted into the body of material. Fig. 6A Typically, the body of material from which the membrane is made is silicone and / or polyurethane (and / or similar elastomers), and the assembled structure is immersed in the body of material while the body of material is in an uncured liquid state. Thereafter, the body of material is cured, for example, by allowing the body of material to dry, so that the body of material solidifies. Once the body of material has dried, the mandrel is typically removed from the inner cavity defined by the bushing and spring.

[0222] The result of the process described above is typically a film of a continuous body of material that extends between each of the helical elongated elements to the spring and also along the length of the spring so as to define a tube in which the spring is embedded. Portions of the film extending from each helical elongated element to the spring define the blades of the impeller. For applications where the impeller includes the elongated element 67, the elongated element is typically embedded in these portions of the film.

[0223] Typically, the impeller 50 is inserted into the subject's body while the impeller 50 is in a radially constrained configuration. In the radially constrained configuration, both the spiral elongated element 52 and the central axial spring 54 become axially extended and radially constrained. Typically, the film 56 of the material body (e.g., silicone and / or polyurethane) changes shape to conform to the shape changes of the spiral elongated element and the axial support spring, and both the spiral elongated element and the axial support spring support the film of the material body. Typically, the inner edge of the film supported by the spring allows the film to change shape without becoming broken or collapsed, because the spring provides a large surface area of ​​the inner edge of the film in conjunction with the film. For some applications, relative to, for example, if a rigid shaft is used to support the inner edge of the film, the inner edge of the film supported by the spring reduces the diameter to which the impeller can be radially constrained, because the diameter of the spring itself can be reduced by axially extending the spring.

[0224] For some applications, proximal bushing 64 of impeller 50 is coupled to axial shaft 92 such that the axial position of the proximal bushing relative to the shaft is fixed and distal bushing 58 of the impeller is slidable relative to the shaft. For some applications, when the impeller is radially constrained for the purpose of inserting the impeller into the body of a subject or for the purpose of withdrawing the impeller from the body of a subject, the impeller is axially extended by sliding the distal bushing distally along the axial shaft. Figure 6A-6CAs shown, after being released into a subject, the impeller assumes its non-radially constrained configuration (the configuration into which the impeller is typically disposed during operation of the impeller).

[0225] It should be noted that for illustrative purposes, in some of the figures, the impeller 50 is shown as not including the Figure 6A-6C All features of the impeller shown and described. The scope of this application includes the use of Figure 6A-6C An impeller of any feature shown and described may be combined with any of the apparatus and methods described herein.

[0226] Reference now Fig.6D , Fig. 6E and Fig. 6F , Fig.6D , Fig. 6E and Fig. 6F is a schematic diagram of an impeller 50 or a portion thereof according to some applications of the present invention. As described above, for some applications, the impeller 50 includes sutures 53. The sutures 53 are wound around the helical elongated element 52 and are configured to promote bonding between the film of the material body (typically an elastomer, such as polyurethane or silicone) and the helical elongated element (typically a shape memory alloy, such as Nitinol).

[0227] As an alternative or in addition to suture 53, for some applications, coil 68 is wrapped around (or placed on) the helical elongated element, such as Fig.6D For example, a tightly wound coil (e.g., a tightly wound nitinol coil) can be wrapped around (or placed on) each helical elongated element. The coil typically facilitates bonding between the film of the body of material and the helical elongated element by increasing the surface area of ​​the junction between the body of material and the helical elongated element to bond with the body of material. For some applications, the structure 59 is modularly formed (e.g., as described below with reference to Fig. 6F ) For some such applications, a coil is placed around each elongated element 52 (eg, by sliding the entire coil over the elongated element in a single motion) before the elongated element is coupled to the proximal and distal bushings of the impeller.

[0228] As an alternative or in addition to suture 53, for some applications, a sleeve 69 is placed around the helical elongate member, such as Fig. 6EAs shown. For example, such a sleeve can be made of a polymer (such as polyester). The sleeve typically promotes the bonding between the film of the material body and the spiral elongated element by increasing the surface area of ​​the joint between the material body and the spiral elongated element to which the material body is bonded. For some applications, the sleeve acts as an intermediary between the material body made of the elongated element and the material body made of the membrane 56, the material body made of the elongated element typically having a relatively high stiffness (and typically Nitinol), and the material body made of the membrane 56 is typically an elastomer with a relatively low stiffness. Therefore, when the material body is dry, the sleeve enhances the strength of the connection between the material body and the spiral elongated element. For some applications, the sleeve 69 is applied to the structure 59. For some such applications, a longitudinal slit is formed in the sleeve to allow the sleeve to be placed around the spiral elongated element 52. After being placed around the spiral elongated element 52, the slit is closed (e.g., by suturing or adhering the slit). For some applications, the structure 59 is formed modularly (e.g., as described below with reference to Fig. 6F ) For some such applications, a sleeve is placed around elongated member 52 before the elongated member is coupled to the proximal and distal bushings of the impeller.

[0229] As yet another alternative or in addition to suture 53, for some applications, elongated member 52 is formed to have a circular (eg, round) cross-section, such as Fig. 6F , which shows a cross-sectional view of an elongated element having a circular cross-section. Fig. 6F The left portion of FIG. 5 shows a cross-sectional view of an elongated member 52 with a body of material of a membrane 56 coupled to the elongated member in the case where the elongated member has a non-circular cross-section (e.g., a square or rectangular cross-section). As shown, it is sometimes the case that the body of material (e.g., silicone and / or polyurethane) from which the membrane is made forms a thinner layer at the corners of the elongated member having a non-circular cross-section. In contrast, Fig. 6F As shown in the left portion of , when the elongated member has a circular cross-section, the body of material typically forms a layer of substantially uniform thickness at the junction with the elongated member. Therefore, for some applications, the elongated member has a circular cross-section.

[0230] For some applications, the proximal and distal bushings 64 and 58 and the elongated element 52 are cut from an alloy tube, for example, as described above. For such applications, after the tube is cut, the elongated element typically has non-circular edges. Therefore, for some applications, after the tube is cut, the edges of the elongated element are rounded, for example, using grinding, sandblasting, tumbling, etching, plasma, surface charging, and / or by adding rounded edges to the elongated element. Alternatively, the proximal and distal bushings and the elongated element can be formed in a modular manner and can be subsequently coupled to each other (e.g., via welding and / or swaging). For some such applications, the elongated element coupled to the proximal and distal bushings has a circular cross-section. As described above with reference to Fig. 6E As mentioned, for some applications, sleeve 69 is placed over the elongate member before the elongate member is coupled to the proximal hub and / or before the elongate member is coupled to the distal hub.

[0231] For some applications, alternative or additional techniques are used to promote bonding between the film of the body of material and the helical elongated element. For example, the helical elongated element may be treated with a surface treatment (e.g., grinding, sandblasting, tumbling, etching, plasma, surface charging, etc.) to roughen the outer surface of the helical elongated element.

[0232] according to Figure 6A-6FAs described above, for some applications of the present invention, the impeller 50 is manufactured by forming a structure having a first bushing 64 and a second bushing 58 at the proximal and distal ends of the structure, the first bushing and the second bushing being interconnected by at least one elongated element 52. The at least one elongated element is radially expanded and formed into at least one helical elongated element by axially compressing the structure at least in part. A body of elastomeric material is coupled to the at least one helical elongated element such that the at least one helical elongated element having the body of elastomeric material coupled thereto defines blades of the impeller. Typically, the coupling is implemented such that a layer of the body of material is disposed around a radially outer edge of the at least one helical elongated element, the layer of the body of material forming an effective edge of the blades of the impeller (i.e., an edge at which the blood pumping function of the impeller is substantially no longer effective). In addition, typically, the method includes performing steps to enhance the bonding of the body of elastomeric material to the at least one helical elongated element in a manner that does not result in protrusion from the effective edge of the blades of the impeller. For example, the suture 53 can be placed in a groove defined by at least one spiral elongated element so that the suture does not protrude from the radially outer edge of the spiral elongated element, and the suture is configured to enhance the bonding of the elastomeric material body to the at least one spiral elongated element. Alternatively or additionally, a tightly wound coil 68 can be placed around at least one spiral elongated element so that the elastomeric material body forms a substantially smooth layer along the radially outer edge of the coil, and the coil is configured to enhance the bonding of the elastomeric material body to the at least one spiral elongated element. Also alternatively or additionally, a sleeve 69 can be placed around at least one spiral elongated element so that the elastomeric material body forms a substantially smooth layer along the radially outer edge of the sleeve, and the sleeve is configured to enhance the bonding of the elastomeric material body to the at least one spiral elongated element. For some applications, at least one spiral elongated element is provided with a circular cross-section so that the layer of elastomeric material formed at the junction of the elastomeric material body and the spiral elongated element has a substantially uniform thickness. As noted above, it is typically desired that the outer edges of the blades of the impeller and the liner 39 (such as Figure 7 The gap G between the outer edges of the impeller blades (shown) is relatively small. Therefore, it is desirable that the effective edge of the impeller blades have no protrusions, because such protrusions would take up some of the space in the gap between the outer edges of the impeller blades (thereby requiring a larger gap) without increasing the effectiveness of the impeller's blood pumping function.

[0233] Reference now Figure 6G and Figure 6H , Figure 6G and Figure 6His a schematic diagram of an elongated element 67 extending between each helical elongated element 52 and the spring 54 according to some applications of the present invention. For some applications, a corresponding annular elongated element 67 extends between each helical elongated element and the spring. Typically, the annular elongated element is a closed ring having a predefined length and is (substantially) inextensible. The length of the annular elongated element is typically predefined so that, as described above, during rotation of the impeller, the helical elongated element (which defines the outer edge of the blades of the impeller) is maintained within a given distance relative to the central axial spring, thereby maintaining a gap between the outer edge of the blades of the impeller and the inner surface of the frame 34. For some applications, such as Figure 6G and Figure 6H As indicated by the enlarged portion of , the impeller is formed by annularly placing the first end of the annular elongated element around each spiral elongated element. Subsequently, the spring 54 is inserted through the proximal bushing 64 and the distal bushing 58 and passes through the second end of the annular spiral elongated element.

[0234] For some applications, at the longitudinal center of the spring 54, the spring is shaped to define a tube 88 (ie, without windings), such as Figure 6G and Figure 6H Typically, the second end of the annular elongate element is annular around the tube at a longitudinal center position of the spring. Typically, this reduces the risk of tearing of the annular elongate element relative to if the second end of the annular elongate element was annular around the windings of the spring. For some applications (not shown), the tube defines a groove therein, and the second end of the annular elongate element is configured to be retained in the groove.

[0235] For some applications, the annular elongate member is annularly shaped around the body of the helical elongate member, such as Figure 6G As shown in the enlarged portion. Figure 6G Enlarged views A and B of show two alternative ways in which the annular elongated element is annular around the body of the spiral elongated element. For some applications, the annular elongated element is annular around the outer surface of the spiral elongated element, as shown in enlarged view A. Alternatively, the spiral elongated element defines a groove 48 on its outer surface, and the annular elongated element is annular around the groove 48 (such as becoming embedded in the groove), as shown in enlarged view B. By embedding the annular elongated element in the groove, the annular elongated element typically does not add to the outer contour of the impeller, and the outer contour of the impeller is defined by the outer surface of the spiral elongated element.

[0236] For some applications, the helical elongate member is shaped to define two holes 91 disposed proximate to each other, and the annular elongate member can pass through the holes in an annular shape, such as Figure 6H As shown in the enlarged portion. Figure 6HEnlarged views A and B of show two alternative ways of annularly forming the elongated ring element through hole 91. For some applications, the elongated ring element surrounds the outer surface of the spiral elongated element and passes through hole 91 in an annular shape, as shown in enlarged view A. Alternatively, the spiral elongated element defines a groove 48 on its outer surface, and the elongated ring element surrounds the groove 48 and passes through hole 91 in an annular shape (such as becoming embedded in the groove), as shown in enlarged view B. By embedding the elongated ring element in the groove, the elongated ring element typically does not add to the outer contour of the impeller, and the outer contour of the impeller is defined by the outer surface of the spiral elongated element.

[0237] Reference now Fig. 8A and Figure 8B , Fig. 8A and Figure 8B Schematic diagram of an impeller 50 and frame 34 of a blood pump catheter 20, 70, or 90 in its non-radially constrained state and radially constrained state, respectively, according to some applications of the present invention. During insertion of the impeller and frame into the body of a subject via a catheter, the impeller and frame are typically disposed in the radially constrained state, and during operation of the blood pump catheter, the impeller and frame are disposed in the non-radially constrained state. As described above, typically, a body of covering material 36 extends from the frame 34. However, for purposes of illustration, the impeller and frame are disposed in the non-radially constrained state. Figure 8A-B 3 shows the frame and impeller without the covering material body 36. Figure 8B As indicated, the frame and impeller are typically maintained in a radially constrained configuration by a transfer conduit 143 .

[0238] Also refer to Figure 8C , Figure 8C FIG. 2 shows a typical bearing assembly used in a prior art axial impeller type blood pump. ... Figure 8C It is for the purpose of serving as a reference point for some applications of the invention described herein. Figure 8C As shown in , the bearing assembly typically includes a radial bearing (indicated by ellipse 200) and a thrust bearing (indicated by circle 202). The radial bearing is configured to reduce radial movement of the impeller by maintaining the axis of the impeller at a given radial position. In response to the impeller pumping blood in a first direction, the force acting on the impeller typically urges the impeller to move in a direction opposite to the first direction. The purpose of the thrust bearing is to oppose this movement of the impeller and maintain the axial position of the impeller. Figure 8CIn the example shown in FIG. 2 , in response to the impeller pumping blood in the direction of arrow 204, the impeller is pushed in the direction of arrow 206, and the thrust bearing opposes this motion. Typically, the bearings experience a great deal of heating and wear due to the friction forces exerted on the bearings. Thrust bearings are typically subject to significant heating and wear due to the fact that the friction forces exerted on the thrust bearings are typically spread over opposing surfaces that have a smaller contact area between the surfaces than is the case with radial bearings.

[0239] As described above, typically the axial shaft 92 passes through the axis of the impeller 50 via the inner cavity 62 of the impeller. Typically, the proximal bushing 64 of the impeller is coupled to the shaft via a coupling element 65, so that the axial position of the proximal bushing relative to the shaft is fixed, and the distal bushing 58 of the impeller is slidable relative to the shaft. The axial shaft itself is radially stabilized via the proximal radial bearing 116 and the distal radial bearing 118.

[0240] Typically, the coupling portion 30 of the frame 34 is coupled to the proximal radial bearing 116, for example via a snap-fit ​​coupling and / or via welding. Typically, at the distal end of the frame 34, the distal strut joint 33 is placed in a groove defined by the outer surface of the distal radial bearing 118, the shape of the groove being set to conform to the shape of the distal strut portion. As shown, the proximal end of the distal end element 108 typically retains the distal strut portion in its closed configuration around the outside of the distal radial bearing 118. For some applications, the device includes a distal extension 121 extending distally from the distal radial bearing. Typically, the extension is configured to reinforce the area of ​​the distal end element into which the distal end of the shaft 92 moves.

[0241] As described above, axial shaft 92 is radially stabilized via proximal radial bearing 116 and distal radial bearing 118. In turn, by passing through inner cavity 62 defined by the impeller, the axial shaft radially stabilizes the impeller relative to the inner surface of frame 34, so that even during rotation of the impeller, a relatively small gap (e.g., a gap as described above) between the outer edge of the blades of the impeller and the inner surface of frame 34 or liner 39 is maintained, as described above. For some applications, axial shaft 92 is made of stainless steel, and proximal bearing 116 and / or distal bearing 118 are made of hardened steel. Typically, when the impeller and frame are crimped (i.e., radially constrained) for the purpose of inserting the impeller and frame into the body of a subject, the distal bushing 58 of the impeller is configured to slide along the axial shaft in the distal direction so that the impeller becomes axially elongated while the proximal bushing is maintained in an axially fixed position relative to the axial shaft. More generally, the impeller is changed from its radially constrained configuration to its non-radially constrained configuration, and vice versa, by the distal bushing sliding on the axial shaft while the proximal bushing is maintained in an axially fixed position relative to the axial shaft.

[0242] Typically, the impeller itself is not directly disposed in any radial bearing or thrust bearing. Instead, bearings 116 and 118 act as radial bearings about the axial axis. Typically, the blood pump catheter does not include any thrust bearings configured to be disposed in the body of the subject and configured to resist the thrust generated by the rotation of the impeller. For some applications, one or more thrust bearings are disposed outside the body of the subject (e.g., in a motor unit), and the force resisting the thrust generated by the rotation of the impeller is provided only by one or more thrust bearings disposed outside the body of the subject. For some applications, mechanical elements and / or magnetic elements are configured to maintain the impeller within a given axial position range. For example, a magnet disposed at the proximal end of the drive cable can be configured to maintain the impeller within a given axial position range.

[0243] For some alternative applications of the present invention, a thrust bearing is used to maintain the axial position of the impeller, and the thrust bearing is disposed in a portion of the blood pump catheter proximal to the impeller so that the thrust bearing does not contact the subject's blood. For example, the thrust bearing can be disposed in an outer tube in which the drive shaft of the impeller is disposed. Alternatively or additionally, the thrust bearing can be disposed outside the body of the subject. For some such applications, because the thrust bearing is disposed outside the body of the subject, the size of the thrust bearing is not constrained by the need to be deployed in a small anatomical location. Therefore, in this case, the contact area between the two opposing surfaces of the thrust bearing is typically greater than 20 square millimeters. For some applications (not shown), the thrust bearing is disposed distal to the impeller and in contact with the subject's blood so that the thrust bearing is cooled by the subject's blood.

[0244] Typically, the operations performed by the computer processor described herein convert the physical state of the memory, which is the real physical item that communicates with the computer processor, to have different magnetic polarity, charge, etc., depending on the technology of the memory used. The computer processor 10 is typically a hardware device programmed with computer program instructions to produce a special-purpose computer. For example, when programmed to perform the techniques described herein, the computer processor 10 typically acts as a special-purpose blood pump computer processor.

[0245] The scope of the present invention includes combining any of the devices and methods described herein with any of the devices and methods described in one or more of the following applications, all of which are incorporated herein by reference:

[0246] Tuval, U.S. Pat. No. 16 / 750,354, filed on January 23, 2020, entitled “Distal tip element for a ventricular assist device”;

[0247] Tuval’s US 2019 / 0209758, which is a continuation of International Application No. PCT / IB2019 / 050186 filed on January 10, 2019 by Tuval and entitled “Ventricular assist device,” published as WO 19 / 138350, which claims priority to:

[0248] U.S. Provisional Patent Application No. 62 / 615,538, filed on January 10, 2018 by Sohn, entitled “Ventricular assist device”;

[0249] U.S. Provisional Patent Application No. 62 / 665,718, filed by Sohn on May 2, 2018, entitled “Ventricular assist device”;

[0250] Tuval’s U.S. Provisional Patent Application No. 62 / 681,868, filed on June 7, 2018, entitled “Ventricular assist device”; and

[0251] Tuval’s U.S. Provisional Patent Application No. 62 / 727,605, filed on September 6, 2018, entitled “Ventricular assist device”;

[0252] Tuval’s US 2019 / 0269840, which is the U.S. national phase of Tuval’s International Patent Application No. PCT / IL2017 / 051273, filed on November 21, 2017, entitled “Blood pumps,” published as WO 18 / 096531, which claims priority to Tuval’s U.S. Provisional Patent Application No. 62 / 425,814, filed on November 23, 2016;

[0253] US 2019 / 0175806 to Tuval, which is a continuation of International Application No. PCT / IL2017 / 051158 filed by Tuval on October 23, 2017, entitled “Ventricular assist device,” published as WO 18 / 078615, which claims priority to US 62 / 412,631 filed by Tuval on October 25, 2016 and US 62 / 543,540 filed by Tuval on August 10, 2017;

[0254] Tuval’s US 2019 / 0239998, which is the U.S. national phase of Tuval’s International Patent Application PCT / IL2017 / 051092, filed on September 28, 2017, and entitled “Blood vessel tube,” published as WO 18 / 061002, which claims priority to Tuval’s U.S. Provisional Patent Application No. 62 / 401,403, filed on September 29, 2016;

[0255] US 2018 / 0169313 to Schwammenthal, which is the U.S. national phase of International Patent Application No. PCT / IL2016 / 050525 filed by Schwammenthal on May 18, 2016, and entitled “Blood pump” (published as WO 16 / 185473), which claims priority to U.S. Provisional Patent Application No. 62 / 162,881 filed by Schwammenthal on May 18, 2015, and entitled “Bloodpump”;

[0256] US 2017 / 0100527 to Schwammenthal, which is the U.S. national phase of International Patent Application No. PCT / IL2015 / 050532 filed by Schwammenthal on May 19, 2015, entitled “Blood pump” (published as WO 15 / 177793), which claims priority to U.S. Provisional Patent Application No. 62 / 000,192 filed by Schwammenthal on May 19, 2014, entitled “Bloodpump”;

[0257] US Patent No. 10,039,874 to Schwammenthal, which is the U.S. national phase of International Patent Application No. PCT / IL2014 / 050289 filed by Schwammenthal on March 13, 2014, and entitled “Renal pump” (published as WO 14 / 141284), which claims priority to: (a) U.S. Provisional Patent Application No. 61 / 779,803 filed by Schwammenthal on March 13, 2013, and entitled “Renal pump,” and (b) U.S. Provisional Patent Application No. 61 / 914,475 filed by Schwammenthal on December 11, 2013, and entitled “Renal pump”;

[0258] Tuval’s U.S. Patent No. 9,764,113, entitled “Curved catheter,” issued on September 19, 2017, which claims priority to Tuval’s U.S. Provisional Patent Application No. 61 / 914,470, filed on December 11, 2013, entitled “Curved catheter”; and

[0259] Tuval's US Patent 9,597,205 is the U.S. national phase of Tuval's International Patent Application PCT / IL2013 / 050495, filed on June 6, 2013, entitled "Prosthetic renal valve" (published as WO13 / 183060), which claims priority to Tuval's U.S. Provisional Patent Application 61 / 656,244, filed on June 6, 2012, entitled "Prosthetic renal valve."

[0260] Those skilled in the art will recognize that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of protection of the present invention includes the combination and sub-combination of the various features described above, as well as changes and modifications of the present invention that are not in the prior art and that would occur to those skilled in the art upon reading the foregoing description.

Claims

1. A device for use with a venous system of a subject, the venous system including one or more branch vessels flowing into the vein at a connection between the vein and the one or more branch vessels, the device comprising: A blood pump catheter, the blood pump catheter comprising: a body of material configured to be placed at a downstream location downstream of the connection and to at least partially obstruct blood flow through the vein at the downstream location, the body of material defining a blood outlet opening; a blood pump including an impeller disposed within a frame, the impeller being configured to pump blood from a region of the vein adjacent the junction and through the blood outlet opening defined by the body of material by rotating within the frame; a blood flow path, the blood flow path passing between (a) a path inlet opening and (b) a path outlet opening, the path inlet opening being disposed at an upstream position upstream of the connection, the path outlet opening leading to a downstream side of the body of material, The blood flow path is configured to direct upstream venous blood flow from the upstream location to downstream of the body of material without the upstream venous blood flow being pumped by the blood pump.

2. The device according to claim 1, wherein: The blood pump includes an elongated blood pump tube defining a blood inlet region disposed within an upstream portion of the elongated blood pump tube, a blood outlet region disposed within a downstream portion of the elongated blood pump tube, and an impeller configured to pump blood into the blood inlet region, through the elongated blood pump tube, and out of the blood outlet region.

3. The device according to claim 1, wherein: The blood pump catheter is configured to flow into one or more lymphatic vessels of a vein, and wherein the blood pump catheter is configured to be placed within the vein such that: The body of material is placed at a downstream location downstream of a connection of the vein to the one or more lymphatic vessels, thereby at least partially obstructing blood flow through the vein at the downstream location, The blood pump is configured to pump blood from a region of the vein adjacent to the connection of the vein to the one or more lymphatic vessels and through the blood outlet opening defined by the body of material, and the blood flow path passes between (a) the path inlet opening disposed upstream of a region of the vein adjacent to the connection between the vein and the one or more lymphatic vessels and (b) the path outlet opening opening to the downstream side of the body of material, The blood flow path is configured to direct upstream venous blood flow from the upstream location to the downstream side of the body of material without the upstream venous blood flow being pumped by the blood pump.

4. The device according to any one of claims 1 to 3, wherein: The blood pump catheter is configured to be placed within the vena cava of the subject such that: The body of material is placed at a downstream location downstream of a connection of the vena cava to one or more renal veins of the subject, thereby at least partially obstructing blood flow through the vena cava at the downstream location, The blood pump is configured to pump blood from a region of the vena cava adjacent the connection of the vena cava to the one or more renal veins through the blood outlet opening defined by the body of material, and the blood flow path passes between (a) the path inlet opening, the path inlet opening being disposed upstream of a connection between the vena cava and the one or more renal veins, and (b) the path outlet opening opening opening to the downstream side of the body of material, The blood flow path is configured to direct blood flow from an infrarenal vena cava blood flow that is not pumped by the blood pump to downstream of the body of material.

5. The apparatus according to claim 4 further comprises a percutaneous left ventricular assist device configured to assist left ventricular function of the subject.

6. The device according to claim 4, wherein: The blood pump includes an elongated blood pump tube defining a blood inlet region disposed within an upstream portion of the elongated blood pump tube, a blood outlet region disposed within a downstream portion of the elongated blood pump tube, and an impeller configured to pump blood into the blood inlet region, through the elongated blood pump tube, and out of the blood outlet region.

7. The device according to claim 6, wherein: The elongated blood pump tube is configured such that the blood outlet region is disposed within a pulmonary artery of the subject and is configured to pump blood into the pulmonary artery of the subject via the elongated blood pump tube.

8. The device according to claim 6 further includes an elongated tube extending downstream from the material body and defining a suprarenal blood inlet opening, wherein the suprarenal blood inlet opening is configured to be disposed within the suprarenal vena cava of the subject, wherein the blood inlet region of the elongated blood pump tube is configured to be disposed downstream of the suprarenal blood inlet opening, and the elongated blood pump tube is configured to pump blood from the suprarenal vena cava blood flow into the pulmonary artery of the subject.

9. The device of claim 4, further comprising an elongated tube configured to extend into a pulmonary artery of the subject, wherein the blood pump is configured to pump blood into the pulmonary artery of the subject via the elongated tube.

10. The device according to claim 9, wherein: The elongated tube defines a suprarenal blood inlet opening configured to be disposed within the suprarenal vena cava of the subject, wherein the blood pump is configured to be disposed downstream of the suprarenal blood inlet opening and is configured to pump blood from the suprarenal vena cava blood flow into the pulmonary artery of the subject.

11. The device according to claim 4, wherein: The diameter of one or more portions of the blood flow path is adjustable such that the flow of blood from the infrarenal vena cava to the right atrium of the subject is adjustable.

12. The apparatus according to claim 11, further comprising: a blood pressure sensor configured to detect the subject's blood pressure; and a computer processor configured to receive a blood pressure of the subject and automatically adjust a diameter of the one or more portions of the blood flow path in response to the detected blood pressure.

13. The device according to claim 11, wherein: The diameter of the one or more portions of the blood flow path is configured to be adjusted in response to an input.

14. The device according to any one of claims 1 to 3, wherein: The blood flow path includes: a funnel having a wide end and a narrow end; and one or more tubes, wherein the wide end of the funnel defines the path inlet opening and the narrow end of the funnel opens into the one or more tubes.

15. The device according to claim 14, wherein: The funnel and the one or more tubes comprise a single continuous blood flow path.

16. The device according to any one of claims 1 to 3, wherein: The diameter of one or more portions of the blood flow path is adjustable such that flow through the blood flow path is adjustable.

17. The apparatus according to claim 16, further comprising: a blood pressure sensor configured to detect the subject's blood pressure; and a computer processor configured to receive a blood pressure of the subject and automatically adjust a diameter of the one or more portions of the blood flow path in response to the detected blood pressure.

18. The device according to claim 16, wherein: The diameter of the one or more portions of the blood flow path is configured to be adjusted in response to an input.

19. A device for use within a blood vessel of a subject, comprising: A blood pump catheter, the blood pump catheter comprising: a body of material disposed on the blood pump conduit and configured to at least partially obstruct blood flow through the vein, the body of material defining a blood outlet opening; a blood pump including an impeller disposed within a frame, the impeller being configured to pump blood through the blood outlet opening defined by the body of material by rotating within the frame; a blood flow path, the blood flow path passing between (a) a path inlet opening and (b) a path outlet opening, the path inlet opening being disposed at a position proximal to the material body and the path outlet opening leading to a position distal to the material body, The blood flow path is configured to direct a blood flow from the path inlet opening to the path outlet opening without the blood flow being pumped by the blood pump.

20. A device for use in an arterial system of a subject, the arterial system comprising an aorta and one or more branch arteries branching from the aorta at a junction between the aorta and the one or more branch arteries, the device comprising: A blood pump catheter, the blood pump catheter comprising: a body of material configured to be placed at a downstream location downstream of the junction between the aorta and the branch artery and to at least partially obstruct blood flow through the aorta at the downstream location, the body of material defining a blood inlet opening; a blood pump comprising an impeller disposed within a frame, the impeller being configured to pump blood from the aorta through the blood inlet opening toward the branch artery by rotating within the frame; a funnel configured to be disposed upstream of a connection between the aorta and the branch artery; and a blood flow path, the blood flow path passing between (a) a path inlet opening and (b) a path outlet opening, the path inlet opening being disposed at an upstream position upstream of a junction of the aorta and the branch artery, the path outlet opening leading to a downstream side of the material body, The blood flow path is configured to direct upstream aortic blood flow from the upstream location to downstream of the body of material without the upstream aortic blood flow being pumped by the blood pump.

21. A device for use in the descending aorta of a subject, the device comprising: A blood pump catheter, the blood pump catheter comprising: a body of material configured to be placed within the descending aorta and to partition the aorta into an upstream compartment and a downstream compartment by at least partially obstructing blood flow through the aorta, the body of material defining a blood outlet opening; A blood pump includes an impeller disposed within a frame, the impeller being configured to pump blood in a downstream direction through the descending aorta, through the blood outlet opening, by rotating within the frame.

22. A device for use within a blood vessel of a subject, comprising: A blood pump catheter configured to be placed within a blood vessel of a subject, the blood pump catheter comprising: an impeller configured to pump blood by rotating; an impeller frame configured to be disposed around the impeller; a blood pump support frame configured to be disposed upstream of the impeller frame and to at least partially align a longitudinal axis of the impeller frame with a local longitudinal axis of the blood vessel by contacting an inner wall of the blood vessel; and a body of material configured to extend from the impeller frame to the blood pump support frame so as to contact a wall of the blood vessel and occlude the blood vessel in a region of the blood vessel surrounding the impeller, the body of material defining a blood outlet opening through which the impeller is configured to pump blood.

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