Cardiac support pumps

Abstract

A medical pumping system can comprise an inflatable balloon having a first end portion configured to be disposed in an atrium of a heart or a ventricle of the heart, and a second end portion configured to be disposed in the ventricle. The medical pumping system can include a tubular member defining a lumen configured to receive the inflatable balloon. The tubular member can comprise a first opening on a first end portion of the tubular member being disposed in the atrium, or in the ventricle, and a second opening at a second end portion of the tubular member being disposed in the ventricle. The inflatable balloon can be configured to occlude the lumen while in an inflated state to direct blood flow through the lumen from the first opening to the second opening.

Description

CARDIAC SUPPORT PUMPSCROSS REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit of U.S. Application No. 63 / 631,195, filed April 8, 2024, the disclosure of which is hereby expressly incorporated by reference herein in its entirety for all purposes.BACKGROUND

[0002] Cardiogenic shock, such as due to acute decompensated heart failure (ADHF-CS), can result in inadequate cardiac output. Inadequate flow of oxygenated blood from the heart can lead to hypotension and / or end organ hypoperfusion. Prompt treatment of cardiogenic shock is needed to avoid or reduce vital organ injury.SUMMARY

[0003] Described herein are methods and devices relating to improving and / or augmenting oxygenated blood output from a heart. One or more fluid pumping systems described herein can be configured to improve oxygenated blood output from the left heart into the aorta. In some instances, a fluid pumping system can comprise a tubular member and an inflatable balloon configured to be at least partially disposed within a lumen of the tubular member. In some instances, a first end portion of the tubular member can comprise a first opening and be disposed along a natural flow path of the blood in a left ventricle or a left atrium. In some instances, a second end portion of the tubular member can comprise a second opening and be in the left ventricle, such as at or proximate to an aortic valve. Inflation of the inflatable balloon can direct blood flow through the lumen of the tubular member, for example, augmenting and / or increasing blood flow into and / or through the left ventricle and to the aortic valve. In some instances, a fluid pumping system can comprise a fluid guide member and an inflatable balloon both configured to be disposed in the left ventricle. The fluid guide member can comprise a first surface portion configured to be oriented toward, and a second surface portion configured to be oriented away from, an anterior leaflet of a mitral valve. At least a portion of the inflatable balloon can be configured to be disposed along and / or proximate to the second surface portion of the fluid guide member such that inflation of the inflatable balloon can direct blood flow from the mitral valve toward the aortic valve. In some instances, a fluid pumping system can comprise an inflatable balloon configured tobe disposed in a left ventricle and incrementally inflate along a natural blood flow path within the left ventricle to sweep and / or push blood flow from a mitral valve toward an aortic valve. In some instances, a cross section of the inflatable balloon while in an inflated state can comprise a triangular or substantially triangular shape. In some instances, the inflatable balloon can be disposed along a guidewire comprising a bend configured to be disposed in the left ventricle. The inflatable balloon can incrementally inflate from portions of the inflatable balloon disposed on the mitral valve side of the bend, to around the bend, and then to portions disposed on the aortic valve side of the bend, so as to direct and / or augment blood flow from the mitral valve to the aortic valve.

[0004] In some instances, a fluid pumping system has a tubular frame including a first tubular branch configured to be at least partially disposed in a brachiocephalic artery and a second tubular branch configured to be at least partially disposed in an ascending aorta. Proximal and distal translation of a piston within the first tubular branch can provide a pumping force that pulls blood from the ascending aorta into the tubular frame through the second tubular branch and then out of the tubular frame into the aortic arch. In some instances, a fluid pumping system can comprise a frame and a foldable membrane coupled to a distal end portion of the frame. A one-way valve coupled to a distal end portion of the foldable membrane can be moved toward the frame with folding of the foldable membrane to thereby facilitate downstream movement of blood through the foldable membrane and frame. In some instances, a fluid pumping system can comprise an outer tubular member and an inner tubular member disposed within the outer tubular member. Sequential alignment of respective ones of a first plurality of openings extending through the outer tubular member and second plurality of openings extending through the inner tubular member can allow sequential inflation of a plurality of balloons circumferentially disposed around the outer tubular member. In some instances, a fluid pumping system can comprise a sheet member comprising a plurality of ferromagnetic portions coupled thereto and configured to be disposed within a pericardial cavity of a heart. An external magnet can be activated to repel and / or attract the plurality of ferromagnetic portions such that the sheet member pushes against and / or pulls on an adjacent heart wall portion, respectively.

[0005] Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and / or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, forexample, an entire body, a portion of a body (e.g. , thorax), a system (e.g. , cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silico, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.

[0006] For purposes of summarizing the disclosure, certain aspects, advantages, and novel features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Various examples are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. However, it should be understood that the use of similar reference numbers in connection with multiple drawings does not necessarily imply similarity between respective examples associated therewith. Furthermore, it should be understood that the features of the respective drawings are not necessarily drawn to scale, and the illustrated sizes thereof are presented for the purpose of illustration of inventive aspects thereof. Generally, certain of the illustrated features may be relatively smaller than as illustrated in some examples or configurations.

[0008] Figure 1 provides a cross-sectional view of a portion of a human circulatory system.|0009| Figure 2 A shows deployment of a fluid pumping system comprising an inflatable balloon disposed within a tubular member using a delivery catheter advanced into a left ventricle in accordance with one or more examples.

[0010] Figures 2B and 2C show the inflatable balloon and tubular member of Figure 2A disposed in the left ventricle while the inflatable balloon is in a deflated state and an inflated state, respectively, in accordance with one or more examples.

[0011] Figures 3 A and 3B show a fluid pumping system comprising an inflatable balloon and a tubular member deployed into a left ventricle, while the inflatable balloon is in a deflated state and an inflated state, respectively, in accordance with one or more examples.

[0012] Figures 4A and 4B show a fluid pumping system comprising a portion disposed in a left atrium and a portion disposed in a left ventricle, while an inflatable balloon of the fluid pumping system is in a deflated state and an inflated state, respectively, in accordance with one or more examples.

[0013] Figure 5 is a flow diagram of an example of a process for directing blood flow in accordance with one or more examples.

[0014] Figure 6A-1 provides a side view of a fluid pumping system comprising a fluid guide member and an inflatable balloon deployed to a left ventricle, while the inflatable balloon is in a deflated state, in accordance with one or more examples. Figure 6A-2 provides a more detailed view of the fluid guide member of Figure 6A-1.

[0015] Figure 6B provides a side view of the fluid guide member and inflatable balloon described with reference to Figures 6A-1 and 6A-2 disposed in the left ventricle, while the inflatable balloon is in an inflated state, in accordance with one or more examples.

[0016] Figures 7A, 7B, 7C-1, 7C-2, 7D and 7E show various views of a fluid pumping system comprising a fluid guide member and an inflatable balloon deployed to a left ventricle in accordance with one or more examples.

[0017] Figure 8 is a flow diagram of an example of a process for directing blood flow in accordance with one or more examples.

[0018] Figures 9A and 9B provide side views of a fluid pumping system comprising a guidewire and an inflatable balloon deployed to a left ventricle, while an inflatable balloon is in a deflated state and an inflated state, respectively, in accordance with one or more examples.

[0019] Figure 10A provides a side view of, and Figure 10B provides a side cross- sectional view, of fluid pumping system deployed to a target site in an aorta, in accordance with one or more examples.

[0020] Figures 11 A, 1 IB, and 11C provide side views of a fluid pumping system comprising a foldable membrane coupled to a frame and deployed into an aorta, where the foldable membrane is fully unfolded, partially folded, and fully folded, respectively, in accordance with one or more examples.

[0021] Figure 12 provides a side view of a fluid pumping system comprising a foldable membrane coupled to a frame and deployed into an aorta, in accordance with one or more examples

[0022] Figures 13A, 13B, 13C provide side views of a fluid pumping system comprising a truncated conical foldable membrane coupled to a frame and deployed into an aorta, where the foldable membrane is fully unfolded, partially folded, and fully folded, respectively, in accordance with one or more examples.

[0023] Figure 14A shows a side view of a fluid pumping system deployed in an aorta, the cardiac peristaltic pump comprising a plurality of inflatable balloons disposed around an outer tubular member, and an inner tubular member disposed within and rotatable relative to the outer tubular member, in accordance with one or more examples.

[0024] Figures 14B, 14C and 14D provide side views of fluid pumping system described with reference to Figure 14A, where the plurality of inflatable balloons is sequentially inflated from a distal-most inflatable balloon to a proximal-most inflatable balloon.100251 Figure 14E provides a side cross-sectional view of the fluid pumping system described with reference to Figure 14 A.

[0026] Figure 15A provides a side view of a sheet member of a fluid pumping system deployed within a pericardial cavity, and an external magnet configured to repel and / or attract ferromagnetic portions coupled to the sheet member, in accordance with one or more examples.

[0027] Figure 15B provides a plan view of the sheet member described with reference to Figure 15A in an expanded and / or unfolded configuration, and Figure 15C provides a perspective view of the sheet member in a collapsed and / or folded configuration.

[0028] Figure 16A provides a perspective view of a sheet member comprising a plurality of ferromagnetic portions coupled thereto in a folded and / or collapsed configuration, and Figure 16B provides a plan view the sheet member in an expanded and / or unfolded configuration, in accordance with one or more examples.

[0029] Figure 17A provides a perspective view of a sheet member comprising a plurality of ferromagnetic portions coupled thereto in a folded configuration and / or collapsed configuration, and Figure 17B provides a plan view the sheet member in an expanded and / or unfolded configuration, in accordance with one or more examples.DETAILED DESCRIPTION

[0030] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0031] Although certain preferred examples are disclosed below, inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and / or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0032] Certain standard anatomical terms of location are used herein to refer to the anatomy of animals, and namely humans, with respect to the preferred examples. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe a spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s) / structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s) / structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element / structure described as “above” another element / structure may represent a position that is below or beside such other element / structure with respect to alternate orientations of the subject patient or element / structure, and vice-versa.

[0033] Figure 1 provides a cross-sectional view of a portion of a human heart 1. The heart 1 includes four chambers, namely the left atrium 2, the left ventricle 3, the rightventricle 4, and the right atrium 5. A wall of muscle, referred to as the septal wall 12, separates the left atrium 2 and right atrium 5, and the left ventricle 3 and right ventricle 4. Blood flow through the heart 1 is at least partially controlled by four valves, the mitral valve 6, aortic valve 7, tricuspid valve 8, and pulmonary valve (not shown). The mitral valve 6 separates the left atrium 2 and the left ventricle 3 and controls blood flow therebetween. The aortic valve 7 separates and controls blood flow between the left ventricle 3 and the aorta 9. The tricuspid valve 8 separates the right atrium 5 and the right ventricle 4 and controls blood flow therebetween. The pulmonary valve separates the right ventricle 4 and the pulmonary trunk or artery (not shown), controlling blood flow therebetween.

[0034] In a healthy heart, deoxygenated blood arriving from the rest of the body generally flows into the right side of the heart 1 for transport to the lungs, and oxygenated blood from the lungs generally flows into the left side of the heart 1 for transport to the rest of the body. For example, during atrial diastole, blood from the inferior and superior venae cavae 10, 11 and coronary sinus (not shown) can flow into the right atrium 5. Oxygen-rich blood from the lungs can flow into the left atrium 2 through the four pulmonary veins (not shown). During atrial systole, as the atrial cardiac muscles contract, blood can be pumped from the right and left atria 5, 2 into the right and left ventricles 4, 3 through the mitral valve 6 and the tricuspid valve 8, respectively. The ventricles can be in a diastole phase while deoxygenated blood from the right atrium 5 flow into the right ventricle 4, and oxygenated blood from the left atrium 2 flow into the left ventricle 3. During ventricular systole, deoxygenated blood from the right ventricle 4 can flow into the pulmonary trunk (not shown) for transport to the lungs (e.g. via the left and right pulmonary arteries), and oxygenated blood can flow from the left ventricle 3 to the aorta 9 for transport to the rest of the body.

[0035] Cardiogenic shock is a condition where the heart does not pump enough oxygenated blood to vital organs. In some cases, cardiogenic shock can occur as a result of acute decompensated heart failure (ADHF-CS). A heart of a patient suffering from cardiogenic shock cannot provide adequate flow of oxygenated blood out of the left side of the heart and through the aorta for end-organ perfusion. Symptoms can include confusion, sweating, rapid breathing, and / or loss of consciousness. Patients with cardiogenic shock require prompt treatment to avoid or reduce injury to the vital organs.

[0036] Described herein are devices, systems and methods relating to increasing oxygenated blood output from a heart. One or more fluid pumping systems described herein can be disposed in a left side of the heart to provide cardiac output support for the heart. The fluid pumping systems can be configured to improve oxygenated blood output from the leftheart into the aorta, such as to increase oxygenated blood flow to end-organs. A fluid pumping system can comprise an inflatable balloon configured to be disposed in a left atrium and / or left ventricle. Inflation of the inflatable balloon, including incremental, sequential and / or directional inflation of the inflatable balloon can be configured to direct, augment and / or pump blood flow into the left ventricle, through the left ventricle and / or out of the left ventricle into an aorta. For example, respective portions of an inflatable balloon can inflate in sequential order along a dimension to enhance cardiac output. In some instances, a fluid pumping system can comprise a peristaltic balloon pump. Improved and / or increased flow of oxygenated blood into the aorta can facilitate improved end-organ perfusion.

[0037] In some instances, a fluid pumping system can comprise a tubular member and an inflatable balloon configured to be at least partially disposed within the tubular member. The tubular member can comprise a first opening on a first end portion a second opening on a second end portion, and define a lumen extending between the first and second openings. In some instances, the inflatable balloon can be disposed within the lumen. In some instances, the tubular member and inflatable balloon can be disposed in a left ventricle. The second end portion of the tubular member can be at or proximate to an aortic valve. The first end portion of the tubular member can be disposed along a natural flow path of the blood in the left ventricle such that inflation of the inflatable balloon can augment and / or increase blood flow through the left ventricle to the aortic valve. In some instances, the first end portion of the tubular member can be disposed in the left ventricle while the second end portion of the tubular member can be disposed at or proximate to the aortic valve. Inflation of the inflatable balloon disposed in the tubular member can direct blood flow into the left ventricle and toward the aortic valve.

[0038] In some instances, a fluid pumping system can comprise a fluid guide member and an inflatable balloon. The fluid guide member and the inflatable balloon can be configured to be disposed in the left ventricle. In some instances, the fluid guide member can comprise a first surface portion configured to be oriented toward, and a second surface portion configured to be oriented away from, an anterior leaflet of a mitral valve. At least a portion of the inflatable balloon can be configured to be disposed along and / or proximate to the second surface portion of the fluid guide member. The inflatable balloon can incrementally inflate along a direction from a portion oriented toward the mitral valve to a portion oriented toward an aortic valve to direct blood flow from the mitral valve toward the aortic valve. In some instances, as the inflatable balloon is inflated, incremental portions of the inflatable balloon can be disposed against respective portions of the second surfaceportion of the fluid guide member to direct blood flow away from the mitral valve and toward the aortic valve to thereby improve cardiac output.

[0039] In some instances, a fluid pumping system can comprise an inflatable balloon configured to be disposed in a left ventricle and incrementally inflate along a natural blood flow path within the left ventricle to sweep and / or push blood flow from a mitral valve toward an aortic valve. In some instances, a shape of the inflatable balloon while in the inflated state can be configured to conform to a shape of the ventricular space, such as during at least a portion of the ventricular systole phase. In some instances, a cross section of the inflatable balloon while in an inflated state can comprise a triangular or substantially triangular shape. In some instances, the inflatable balloon can be disposed along a guide wire comprising a portion configured to be disposed in the left ventricle. The portion of the guidewire in the left ventricle can comprise a bend, a convex portion of the bend being oriented toward an apex of the heart. The inflatable balloon can incrementally inflate from portions of the inflatable balloon disposed on the mitral valve side of the bend, to around the bend, and then to portions disposed on the aortic valve side of the bend, so as to direct and / or augment blood flow from the mitral valve to the aortic valve.

[0040] One or more of the inflatable balloons described herein can assume a deflated state during delivery to a target site. The inflatable balloon can be in a deflated state during at least a portion of a ventricular diastole phase. The inflatable balloon can assume an inflated state during at least a portion of a ventricular systole phase. The inflatable balloon can transform between the deflated state and the inflated state, such as along with the ventricular change between diastole and systole during the cardiac cycle. In some instances, a deflated state during ventricular diastole can be different from a deflated state during delivery to the target site.

[0041] In some instances, a fluid pumping system can be at least partially disposed in an aorta to provide cardiac output support for the heart. The fluid pumping system can be configured to improve oxygenated blood output from the left heart into the aorta and / or downstream flow of oxygenated blood through the aorta, such as to increase oxygenated blood flow to end-organs. In some instances, a fluid pumping system can comprise cardiac piston pump having a tubular frame including a first tubular branch configured to be at least partially disposed in a brachiocephalic artery and a second tubular branch configured to be at least partially disposed in an ascending aorta. Proximal and distal translation of a piston within the first tubular branch can provide a pumping force that pulls blood from the ascending aorta into the tubular frame through the second tubular branch andthen out of the tubular frame into the aortic arch, thereby facilitating downstream blood flow from the left ventricle.

[0042] In some instances, a fluid pumping system can comprise a cardiac piston pump that includes a frame and a foldable membrane coupled to a distal end portion of the frame. A one-way valve coupled to a distal end portion of the foldable membrane can be moved toward and away from the frame with folding and unfolding of the foldable membrane, respectively. The cardiac piston pump can be deployed to an aorta such that movement and / or translation of the one-way valve toward the frame can facilitate downstream blood flow away from a left ventricle and through the aorta.

[0043] In some instances, a fluid pumping system can comprise a cardiac peristaltic pump having an outer and inner tubular member disposed within an aorta. The outer tubular member can comprise a first plurality of openings extending through respective wall portions thereof. The inner tubular member can comprise a second plurality of openings extending through respective wall portions thereof. A plurality of inflatable balloons can be circumferentially disposed around the outer tubular member at respective positions along a longitudinal dimension of the outer tubular member. Each inflatable balloon can be aligned with a respective one of the first plurality of openings. Sequential alignment of respective ones of the first and second plurality of openings can allow inflation fluid from within the second tubular member to sequentially inflate the plurality of balloons from a distal most inflatable balloon to a proximal most inflatable balloon, thereby providing peristaltic pumping.

[0044] In some instances, a fluid pumping system can comprise a pericardial cavity pump having a sheet member configured to be disposed within a pericardial cavity of a heart. The sheet member can comprise a plurality of ferromagnetic portions coupled thereto. An external magnet can be activated to repel and / or attract the plurality of ferromagnetic portions such that the sheet member pushes against and / or pulls on an adjacent heart wall portion, respectively. Pushing against and / or pulling on the adjacent heart wall portion can augment a pumping function of the heart.

[0045] One or more fluid pumping systems described herein can be configured to provide circulatory support to patients suffering from cardiogenic shock while reducing or avoiding the adverse events associated with typical temporary mechanical circulatory support (tMCS) devices. The fluid pumping systems can provide cardiac output support such that the heart can supply adequate oxygenated blood to various organs throughout the body, including for acute decompensated heart failure (ADHF) patients with earlier stages of cardiogenic shock. In some instances, a fluid pumping system can provide output support for the heartsuch that the augmented cardiac output can supply adequate oxygenated blood to the various organs.

[0046] The pumping systems described herein can be delivered to a target site using a minimally invasive transcatheter approach. Positioning to the target site can be made through the aorta and aortic valve. In some instances, an access site can be made in a femoral artery. Delivery of at least a portion of a pumping system into a left ventricle and / or left atrium can be made through the access site in the femoral artery. In some instances, a distal portion of a delivery catheter carrying one or more components of a pumping system, such as an inflatable balloon, tubular member, and / or fluid guide member, can be inserted into the access site on the femoral artery and advanced into the aorta and through the aortic valve, and into the left ventricle and / or left atrium.

[0047] It will be understood that one or more components of the fluid pumping system can undergo various processes in preparation for their use in the procedures, including for example sterilization processes. The fluid pumping systems can be sterilized fluid pumping systems. For example, one or more of inflatable balloons, tubular members, fluid guide members, guidewires, and delivery catheters can be sterilized.

[0048] Although the fluid pumping systems are described primarily with reference to delivery to a left ventricle and / or left atrium, it will be understood that one or more of the pumping systems described herein can be deployed to a right ventricle and / or right atrium. In some instances, the fluid pumping systems can be deployed to any number of chambers, organs, and / or lumens to facilitate improved fluid output of the chambers, organs, and / or lumens.

[0049] The term “associated with” is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being “associated with” a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

[0050] Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and / or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, forexample, an entire body, a portion of a body (e.g. thorax), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silico, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.

[0051] Figures 2A, 2B and 2C show a fluid pumping system 200 deployed to a ventricle, such as a left ventricle 3, of a heart 1. The fluid pumping system 200 can comprise an inflatable balloon 202 and a tubular member 250. Figure 2A shows a side view of the inflatable balloon 202 and the tubular member 250 being deployed into the left ventricle 3. Figures 2B and 2C show a side cross-sectional view of the tubular member 250, and a side view of the inflatable balloon 202, disposed in the left ventricle 3, while the inflatable balloon 202 is in a deflated state and an inflated state, respectively. Referring to Figure 2A, a portion of a guidewire 298 can be disposed in the left ventricle 3. A distal portion 292 of a delivery catheter 290 carrying the inflatable balloon 202 and the tubular member 250 can be advanced along the guidewire 298 into the left ventricle 3 through the aorta 9. For example, insertion of the pumping system 200 can be made at an access site on a femoral artery. In some instances, the guidewire 298 can be positioned into the left ventricle 3. In some instances, the delivery catheter 290 can be advanced along the guidewire 298 to position a distal portion 292 of the delivery catheter 290 into an aorta 9 and through an aortic valve 7 to allow positioning and / or advancement of the inflatable balloon 202 and the tubular member 250 into the left ventricle 3. In some instances, the inflatable balloon 202 and the tubular member 250 can be advanced out of a distal end opening 296 at a distal end 294 of the delivery catheter 290, and / or the delivery catheter 290 can be retracted to deploy the inflatable balloon 202 and the tubular member 250 through the distal end opening 296 of the delivery catheter 290, and into the left ventricle 3. In some instances, the inflatable balloon 202 can be disposed within or substantially within the tubular member 250 during delivery to the left ventricle 3. The inflatable balloon 202 can assume the deflated state while being advanced along the anatomical pathway to a target site. For example, the inflatable balloon 202 can be in the deflated state while disposed within the tubular member 250 for delivery to the target site. In some instances, the tubular member 250 can assume a collapsed and / or deflated state during delivery to the target site to facilitate transcatheter delivery. Figure 2A shows the tubular member 250 being deployed from the delivery catheter 290 in the collapsed and / or deflatedstate. In some instances, the tubular member 250 and / or the inflatable balloon 202 can remain in the deflated state until after deployment from the delivery catheter 290.

[0052] The tubular member 250 can define a lumen 252 configured to at least partially receive the inflatable balloon 202. The tubular member 250 can comprise a first opening 262 on a first end portion 254, and a second opening 264 on a second end portion 256. For example, the tubular member 250 can define a lumen 252 and first and second openings 262, 264, the lumen 252 extending between first and second openings 262, 264. The first end portion 254 can be configured to be oriented away from an outflow valve of the ventricle. The second end portion 256 can be configured to be oriented toward the outflow valve of the ventricle. Figure 2B shows the inflatable balloon 202 and the tubular member 250 disposed within the left ventricle 3. For example, the first end portion 254 can be oriented away from outflow valve, such as the aortic valve 7, while the second end portion 256 can be oriented toward outflow valve, such as the aortic valve 7. In some instances, the first end portion 254 can be oriented toward an apical region, including an apex, of the heart 1. The inflatable balloon 202 can be at least partially received in the lumen 252 of the tubular member 250. In some instances, the inflatable balloon 202 can be entirely received within the lumen 252 of the tubular member 250.

[0053] In some instances, after the tubular member 250 is disposed at its target site in the left ventricle 3, the tubular member 250 can be transformed from the collapsed and / or deflated state to an expanded and / or inflated state. For example, Figure 2B shows the tubular member 250 in the expanded and / or inflated state while the inflatable balloon 202 is in the deflated state. The tubular member 250 can expand to transform to the expanded and / or inflated configuration at or proximate to its target site. In some instances, the tubular member 250 can have a longitudinal dimension, such as a length, of about 35 millimeters (mm) to about 60 millimeters (mm), including about 40 millimeters (mm) to about 60 millimeters (mm), and about 40 millimeters (mm) to about 55 millimeters (mm). In some instances, the tubular member 250 can be inflated after deployment to the target site, such as prior to inflation of the inflatable balloon 202. In some instances, while the tubular member 250 is in the expanded state, at least a portion of the tubular member 250 can have a circular or substantially circular lateral cross-sectional shape. The lumen 252 can have a circular or substantially circular lateral cross-sectional shape. The cross-section can be taken along a plane perpendicular or substantially perpendicular to the longitudinal dimension. For example, at least a portion of the tubular member 250 can assume a cylindrical shape, including a hollow cylindrical shape. A central lumen of the cylindrical shape can form thelumen 252. In some instances, while the tubular member 250 is in an expanded configuration, at least a portion of the tubular member 250 can have a non-circular lateral cross-sectional shape, such as an oval shape. At least a portion of the tubular member 250 can assume an elliptic cylindrical shape, including a hollow elliptic cylindrical shape. For example, the lumen 252 can have an oval lateral cross-sectional shape. In some instances, the tubular member 250 can comprise a tubular inflatable balloon 270. The tubular inflatable balloon 270 can assume a deflated configuration during at least a portion of the advancement through an anatomical pathway to the target site. The tubular inflatable balloon 270 can be inflated at or proximate to the target site to assume the inflated configuration, including after deployment from the delivery catheter 290. The tubular inflatable balloon 270 can assume a tubular form, such as while in the inflated state. For example, inwardly oriented surface portions 272 of the tubular inflatable balloon 270 can define the lumen 252 while the tubular inflatable balloon 270 is in the inflated state. Outwardly oriented surface portion 274 can be oriented toward respective portions of the left ventricle 3. In some instances, a lateral cross section of the inwardly oriented surface 272 and / or outwardly oriented surface 274 can form an oval shape, including a circular or substantially circular shape. A first end portion 276 and a second end portion 278 of the tubular inflatable balloon 270 can form the first and second end portions 254, 256 of the tubular member 250, respectively. For example, a second end 280 of the tubular inflatable balloon 270 can define the second opening 264.

[0054] In some instances, the tubular inflatable balloon 270 and the inflatable balloon 202 can form an integrated unit. For example, a multi-lumen inflation tube 282 can be coupled to the tubular inflatable balloon 270 and the inflatable balloon 202 for inflating and / or deflating the tubular inflatable balloon 270 and the inflatable balloon 202. In some instances, the multi-lumen inflation tube 282 can comprise respective inflation tube portions 284, 286 in fluid communication with a respective portion of the inflatable balloon 202 and the tubular inflatable balloon 270 to inject and / or withdraw inflation fluid from the tubular inflatable balloon 270 and the inflatable balloon 202. The inflation fluid can be a liquid, such as saline, or gas.

[0055] Figure 2B shows the first end portion 254 and the second end portion 256 of the tubular member 250 disposed within the left ventricle 3. The first opening 262 on the tubular member 250 can be oriented to receive blood flowing into the left ventricle 3 through the mitral valve 6. For example, the first opening 262 can be oriented toward, and / or disposed within and / or adjacent to, the apical region, such as the apex of the heart 1. The second opening 264 can be oriented toward and / or disposed adjacent to the aortic valve 7. In someinstances, the first end portion 254 of the tubular member 250 can comprise a curvature 266 on a portion of the tubular member 250 opposingly oriented relative to the first opening 262. For example, the curvature 266 can be on an exterior portion of the tubular member 250 oriented toward the apical region, including ventricular wall portions of the apical region, of the heart 1. The curvature 266 can comprise a convexly curved exterior surface portion configured to be oriented toward, conform to, and / or fit against, a ventricular wall portion. In some instances, the first opening 262 can be oriented laterally on the tubular member 250, such as relative to a longitudinal axis of the tubular member 250. In some alternative instances, the first opening 262 can be at the first end 258 of the tubular member 250. In some instances, the second opening 264 can be at a second end 260 of the tubular member 250. For example, the second end 260 of the tubular member 250 can define the second opening 264. In some instances, the first opening 262 and the second opening 264 can be oriented at an angle relative to one another.

[0056] While the tubular member 250 is disposed in the left ventricle 3, the first opening 262 can be configured to be disposed in the flow path of the blood entering the left ventricle 3 through the mitral valve 6 such that the blood can enter the lumen 252 through the first opening 262. In some instances, the first end portion 254 of the tubular member 250 can be configured to be at least partially disposed within the apical region of left ventricle 3. While the tubular member 250 is disposed in the left ventricle 3, the second end 260 can be disposed at or proximate to the aortic valve 7. In some instances, the second end 260 can be disposed at the aortic valve 7 without interfering with the function of the aortic valve 7. Alternatively, the second end 260 can be disposed at a position spaced from the aortic valve 7 while providing desired blood flow to the aortic valve 7. For example, the tubular member 250 can be configured to extend from the apical region of the left ventricle 3 to or substantially to the aortic valve 7. In some instances, a first end 258 of the tubular member 250 can be disposed in the apical region of the left ventricle 3, while the second end 260 of the tubular member 250 is disposed at or proximate to the aortic valve 7.

[0057] In some instances, the second opening 264 can have a size, including a lateral dimension and / or diameter, the same as or similar to that of the aortic valve 7. In some instances, the second opening 264 can have a size, including a lateral dimension and / or diameter, that is smaller than that of the aortic valve 7. In some instances, the first opening 262 can have a size, including a lateral dimension and / or diameter, that is the same as or similar to that of the second opening 264. In some instances, the first opening 262 can have asize, including a lateral dimension and / or diameter, that is larger than that of the second opening 264.

[0058] The inflatable balloon 202 can be disposed within or substantially within the lumen 252 of the tubular member 250. A first end portion 204 of the inflatable balloon 202 can be oriented toward the first end portion 254 of the tubular member 250 and the second end portion 206 of the inflatable balloon 202 can be oriented toward the second end portion 256 of the tubular member 250. In some instances, the first end portion 204 of the inflatable balloon 202 can be oriented toward the apex and the second end portion 206 of the inflatable balloon 202 can be oriented toward the aortic valve 7. As described in further detail herein, in some instances, the inflatable balloon 202 can be inflated incrementally and / or sequentially from the first end portion 204 to the second end portion 206 to direct, pump and / or augment blood flow through the left ventricle 3 and into the aorta 9.

[0059] In some instances, the first end portion 204 of the inflatable balloon 202 can be received in the portion of the lumen 252 of the first end portion 254 of the tubular member 250, while the inflatable balloon 202 is deployed to the left ventricle 3. For example, the first end portion 204 of the inflatable balloon 202 can be received in the portion of the lumen 252 of the first end portion 254 of the tubular member 250 while the inflatable balloon 202 is in the deflated state. In some instances, the second end portion 206 of the inflatable balloon 202 can be received in the portion of the lumen 252 of the second end portion 256 of the tubular member 250 while the inflatable balloon 202 is deployed to the left ventricle 3. For example, the second end portion 206 of the inflatable balloon 202 can be received in the portion of the lumen 252 of the second end portion 256 of the tubular member 250 while the inflatable balloon 202 is deployed to the left ventricle 3 and while the inflatable balloon 202 is in the deflated state. Alternatively, while the inflatable balloon 202 is deflated, the second end portion 206 of the inflatable balloon 202 can be received in a portion of the lumen 252 proximal of the second end portion 256 of the tubular member 250. Figure 2B shows the inflatable balloon 202 in the deflated state. In some instances, the inflatable balloon 202 can be in the deflated state during at least a portion of a ventricular diastole phase. The inflatable balloon 202 can assume the deflated state to facilitate filling of the lumen 252 with blood during ventricular diastole. For example, at least a portion of blood flowing through the inflow valve, such as the mitral valve 6, can flow through the first opening 262 on the first end portion 254 and into the lumen 252 of the tubular member 250.

[0060] Figure 2C shows the inflatable balloon 202 in a fully inflated state. The tubular member 250 can be in the inflated state. In some instances, the inflatable balloon 202can assume an elongate shape in the fully inflated state, including an elongate shaped having a convexly curved surface portion on a first end portion 204. The convexly curved surface portion can be oriented toward an inner surface portion of the tubular member 250 having a corresponding shape, such as a portion tubular member 250 having the curvature 266 on an exterior surface. The inflatable balloon 202 can be in the inflated state during at least a portion of a ventricular systole phase. The inflatable balloon 202 can reversibly transform between the deflated state and the inflated state, such as along with the cardiac cycle, transforming between the deflated state and the inflated state as the left ventricle 3 cycles between diastole and systole, respectively. Inflation of the inflatable balloon 202 from the deflated state to the inflated state can direct blood flow through the lumen 252, such as from the first end portion 254 to the second end portion 256 of the tubular member 250. The inflatable balloon 202 can be directionally inflatable, such as long the portion of the guidewire 298 disposed in the left ventricle 3, so as to direct blood flow through the lumen 252 of the tubular member 250 from the first opening 262 toward the second opening 264.

[0061] In some instances, inflation and deflation of the inflatable balloon 202 can be synchronized with the heartbeat to augment blood flow through the heart ventricle, such augmentation of flow into the heart ventricle through an inflow valve and out of the heart ventricle through an outflow valve. Blood flowing through the mitral valve 6 and into the left ventricle 3 can flow through the first opening 262 into the lumen 252 of the tubular member 250. Incremental inflation of the inflatable balloon 202 can direct and / or augment blood flow through the lumen 252 towards the second opening 264 on the second end portion 256 oriented towards the aortic valve 7 of the ventricle 3. In some instances, the inflatable balloon 202 can incrementally inflate, such as during at least a portion of ventricular systole, to direct blood flow through the tubular member 250 from mitral valve 6 towards the aortic valve 7. In some instances, the inflatable balloon 202 can incrementally and / or sequentially inflate along a longitudinal dimension. In some instances, the inflatable balloon 202 can inflate incrementally from the deflated state to the inflated state along a longitudinal dimension of the inflatable balloon 202. For example, adjacent portions of the inflatable balloon 202 can sequentially inflate from the first end portion 204 toward the second end portion 206 to provide the inflatable balloon 202 in the inflated state. Dashed lines along respective lateral dimensions of the inflatable balloon 202 dividing the inflatable balloon 202 into respective portions in Figure 2B illustrate an example of incremental portions of the inflatable balloon 202 that can be sequentially inflated to provide the inflatable balloon 202 in the fully inflated state. For example, the inflatable balloon 202 can assume a number of intermediate inflatedstates as the inflatable balloon 202 is incrementally inflated from the deflated state to the fully inflated state. Inflating the inflatable balloon 202 to provide incremental portions of the inflatable balloon 202 in the various inflated states to occlude incremental portions of the lumen 252 during at least a portion of ventricular systole. For example, incremental and / or respective portions of the lumen 252 can be occluded as the inflatable balloon 202 is incrementally inflated. Black arrows in Figure 2B show the direction of incremental inflation of the inflatable balloon 202. Dashed arrows in Figure 2B show the direction of blood flow through the lumen 252 as the inflatable balloon 202 is inflated incrementally.

[0062] In some instances, while the inflatable balloon 202 is in the fully inflated state, the first end portion 204 of the inflatable balloon 202 can be disposed in the lumen 252 of the first end portion 254 of the tubular member 250. A second end portion 206 of the inflatable balloon 202 can be disposed in the lumen 252 of the second end portion 256 of the tubular member 250. In some instances, while the inflatable balloon 202 is in the fully inflated state, the inflatable balloon 202 can be entirely received within the tubular member 250. In some instances, while the inflatable balloon 202 is in the fully inflated state, the inflatable balloon 202 can extend along the entire or substantially entire length of the lumen 252. In some instances, a shape of the inflatable balloon 202 can conform to a shape of the lumen 252 to allow incremental occlusion of the lumen 252 as the inflatable balloon 202 is incrementally inflated. In some instances, the inflatable balloon 202 can occlude the lumen 252, including from the first opening 262 to the second opening 264, such as an entire or substantially entire length of the lumen 252 in the fully inflated state. The inflatable balloon 202 can directionally inflate to occlude incremental portions of the lumen 252 and direct the blood flow through the lumen 252 from the first opening 262 to the second opening 264.

[0063] hi some instances, the inflatable balloon 202 can deflate incrementally from the inflated state to the deflated state. In some instances, the inflatable balloon 202 can deflate incrementally along the longitudinal dimension of the inflatable balloon, including from the first end portion 204 toward the second end portion 206. For example, adjacent portions of the inflatable balloon 202 can sequentially deflate following the same or similar sequence as the inflation process. For example, a portion of the inflatable balloon 202 that is inflated prior to another portion of the inflatable balloon 202 can be deflated prior that other portion of the inflatable balloon 202. In some instances, portions of the inflatable balloon 202 can be deflated while other portions of the inflatable balloon 202 are inflated. In some instances, deflating portions of the inflatable balloon 202 while other portions of the inflatable balloon 202 are inflated can facilitate subsequent inflow of blood into the leftventricle 3 and / or lumen 252 of the tubular member 250. In some instances, deflation of the inflatable balloon 202 can begin after the inflatable balloon 202 assumes the fully inflated state. For example, the inflatable balloon 202 can directionally inflate to occlude incremental portions of the lumen 252 the inflatable balloon 202, and then sequentially deflate from the first end portion 204 toward the second end portion 206 after the inflatable balloon 202 assumes the fully inflated state. Alternatively, the inflatable balloon 202 can sequentially deflate as the inflatable balloon 202 sequentially inflates. For example, the inflatable balloon 202 can sequentially occlude corresponding portions of the lumen 252 for directing the blood flow through the lumen 252 from the first opening 262 to the second opening 264. A portion of the inflatable balloon 202 can be inflated at any one time such that the inflatable balloon 202 does not assume a fully inflated state.

[0064] Figures 3A and 3B show a fluid pumping system 300 deployed to a ventricle of a heart 1, such as a left ventricle 3, while an inflatable balloon 302 of the fluid pumping system 300 is in a deflated state and an inflated state, respectively. The fluid pumping system 300 can comprise a tubular member 350 defining a lumen 352 configured to at least partially receive the inflatable balloon 302. Figures 3A and 3B show a side cross- sectional view of the tubular member 350, and a side view of the inflatable balloon 302. The inflatable balloon 302 and / or tubular member 350 can be disposed along a portion of a guidewire positioned into the left ventricle 2. In some instances, the inflatable balloon 302 can expand radially. For example, inflating the inflatable balloon 302 can comprise increasing a lateral dimension, such as a diameter, of the inflatable balloon 302. The lateral dimension can be perpendicular or substantially perpendicular to a longitudinal dimension. Inflation of the inflatable balloon 302 can occlude at least a portion of the lumen 352 to facilitate direction of blood flow through the lumen 352 of the tubular member 350. Black arrows in Figure 3B show the radial expansion of the inflatable balloon 302. The dashed lines extending along the longitudinal dimension of the inflatable balloon 302, such as from a first portion 304 to a second end portion 306 of the inflatable balloon 302, show the increase in the lateral dimension as the inflatable balloon 302 is inflated. Dashed arrows in Figure 3B show the direction of blood flow through the lumen 352 as the inflatable balloon 302 is inflated radially. In some instances, inflation of the inflatable balloon 302 disposed along the guidewire can comprise a uniform or substantially uniform increase in a lateral dimension of the inflatable balloon 302 along its longitudinal dimension, including an entire or substantially entire length, of the inflatable balloon 302. Alternatively, inflation of the inflatable balloon 302 can comprise sequential and / or incremental increase in a lateraldimension of the inflatable balloon 302 along longitudinal portions of the inflatable balloon 302. For example, directional inflation of the inflatable balloon 302 can comprise radial expansion of incremental and / or sequential portions of the inflatable balloon 302 along a direction from the first end portion 304 to the second end portion 306.

[0065] The tubular member 350 can comprise a first opening 362 on a first end portion 354, and a second opening 364 on a second end portion 356. The first end portion 354 can be configured to be oriented away from an outflow valve of the ventricle, such as an aortic valve 7 of the left ventricle 3. The second end portion 356 can be configured to be oriented toward the outflow valve of the ventricle. In some instances, the first end portion 354 can be oriented toward an apex of the heart 1 while the second end portion 356 is oriented toward the aortic valve 7. As described in further detail herein, the inflatable balloon 302 in the inflated state can occlude at least a portion of the lumen 352 to direct blood flow from the first end portion 354 toward the second end portion 356. In some instances, the inflatable balloon 302 can deflate radially, for example decreasing in size along the lateral dimension. In some instances, the inflatable balloon 302 can sequentially inflate and / or deflate. For example, sequential portions of the inflatable balloon 302 can radially deflate, adjacent portions of the inflatable balloon 302 deflating in the same order as that for inflation.

[0066] In some instances, the fluid pumping system 300 can comprise a fluid valve 390 disposed within the lumen 352 of the tubular member 350. The fluid valve 390 can be configured to prevent or reduce upstream flow from within the lumen 352 through the first opening 362, such as during inflation of the inflatable balloon 302. For example, the fluid valve 390 can be configured to allow antegrade blood flow into the lumen 352 through the first opening 362 while preventing retrograde blood flow from within the lumen 352 out of the first opening 362. In some instances, the fluid valve 390 can be disposed within the lumen 352 in the first end portion 354 of the tubular member 350. In some instances, the fluid valve 390 can be disposed within the lumen 352 at or proximate to the first opening 362. In some instances, the fluid valve 390 can be disposed within the lumen 352 at or proximate to the first end 358 of the tubular member 350. In some instances, the fluid valve 390 can comprise a one-way valve configured to allow blood flow into the lumen 352 while preventing or reducing blood flow out of the lumen 352 through the first opening 362.

[0067] The fluid pumping system 300 can comprise one or more other features of the fluid pumping system 200 described with reference to Figures 2 A through 2C. In some instances, remaining features of the fluid pumping system 300 can be the same as or similar to that of the fluid pumping system 200 described with reference to Figures 2A through 2C.For example, the inflatable balloon 302 can reversibly transform between the deflated state and the inflated state. Figure 3A shows the inflatable balloon 302 in the deflated state. In some instances, the inflatable balloon 302 can be in the deflated state during at least a portion of a ventricular diastole phase. In some instances, the inflatable balloon 302 can inflate, such as during at least a portion of ventricular systole, to direct blood flow that flows through the first opening 362 and into the lumen 352 of the tubular member 350 to and out of the second opening 364 so as to augment flow from the mitral valve 6 to the aortic valve 7. While in the inflated state, the first end portion 304 of the inflatable balloon 302 can be oriented toward the first end portion 354 of the tubular member 350. The second end portion 306 of the inflatable balloon 302 can be oriented toward the second end portion 356 of the tubular member 350. In some instances, the first end portion 354 of the tubular member 350 can comprise a curvature 366 on a portion of the tubular member 350 opposingly oriented relative to the first opening 362. For example, the first opening 362 can be oriented laterally on the tubular member 350, such as relative to a longitudinal axis of the tubular member 350. In some instances, the second opening 364 can be at a second end 360 of the tubular member 350. In some instances, the inflatable balloon 302 while in the inflated state can fill and / or occlude, or substantially fill and / or occlude, portions of the lumen 352 proximal of the fluid valve 390. In some instances, the tubular member 350 can comprise a tubular inflatable balloon 370. In some instances, a multi-lumen inflation tube 382 can be coupled to the tubular inflatable balloon 370 and the inflatable balloon 302. For example, respective inflation tube portions 384, 386 can be in fluid communication with a respective portion of the inflatable balloon 302 and tubular inflatable balloon 370 for injection and / or withdrawal of inflation fluid.

[0068] Figures 4A and 4B show a fluid pumping system 400 deployed to a heart 1 , while an inflatable balloon 402 of the fluid pumping system 400 is in a deflated state and an inflated state, respectively. The fluid pumping system 400 can comprise a tubular member 450 defining a lumen 452 configured to at least partially receive the inflatable balloon 402. Figures 4A and 4B show a side cross-sectional view of the tubular member 450, and a side view of the inflatable balloon 402. The inflatable balloon 402 and / or tubular member 450 can be disposed along a portion of a guidewire disposed in the left ventricle 2. A first end portion 454 of the tubular member 450 can be configured to be disposed in an atrium, such as a left atrium 2, of the heart 1. A second end portion 456 of the tubular member 450 can be disposed in a ventricle, such as left ventricle 3, of the heart 1. For example, the tubular member 450 can extend from the atrium, through an inflow valve of the ventricle and into the ventricle.The second end portion 456 can be disposed within the ventricle and oriented toward an outflow valve of the ventricle. In some instances, the first end portion 454 of the tubular member 450 can be disposed in a left atrium 2 and the second end portion 456 of the tubular member 450 can be disposed in a left ventricle 3. The tubular member 450 can extend from the left atrium 2, through a mitral valve 6 and into the left ventricle 3 such that the second end portion 456 can be disposed within the left ventricle 3 and oriented toward an aortic valve 7. In some instances, the tubular member 450 can comprise a curved portion 466 disposed in the ventricle between the first and second end portions 454, 456. A portion of the tubular member 450 disposed in the left ventricle 3 between the mitral valve 6 and the aortic valve 7 can have a bend such that the second end portion 456 can be disposed at or proximate to the aortic valve 7. In some instances, a convex portion of the curved portion 466 can be oriented toward an apex of the heart 1. In some instances, the tubular member 450 can assume a “U” shape. In some instances, the tubular member 450 can have a longitudinal dimension, such as a length, of about 70 millimeters (mm) to about 150 millimeters (mm), including about 80 millimeters (mm) to about 140 millimeters (mm), and about 70 millimeters (mm) to about 130 millimeters (mm).

[0069] The first end portion 454 of the tubular member 450 can comprise a first opening 462. The second end portion 456 of the tubular member 450 can comprise a second opening 464. For example, the first opening 462 can be at the first end 458 of the tubular member 450. A second opening 464 can be at the second end 460 of the tubular member 450. The lumen 452 can extend from the first opening 462 to the second opening 464 to allow blood flow to enter the first opening 462 disposed in the left atrium 2 and flow through the lumen 452 to the second opening 464 disposed at or proximate to the aortic valve 7. As described in further detail herein, incremental inflation of the inflatable balloon 402 can direct blood flow from the left atrium 2, through the left ventricle 3 and to the aortic valve 7.

[0070] Figure 4 A shows the inflatable balloon 402 in the deflated state, while the tubular member 450 is in an expanded and / or inflated state. In some instances, the inflatable balloon 402 can assume the deflated state during at least a portion of ventricular diastole. The deflated state can facilitate filling of the lumen 452 of the tubular member 450 with blood during ventricular diastole. In some instances, while in the deflated state, a first end portion 404 of the inflatable balloon 402 can be disposed in the left atrium 2 and a second end portion 406 of the inflatable balloon 402 can be disposed in the left ventricle 3. In some instances, while in the deflated state, a first end of the inflatable balloon 402 can be disposed in the left atrium 2.

[0071] Figure 4B shows the inflatable balloon 402 in a fully inflated state. The inflatable balloon 402 can be in the fully inflated state during at least a portion of a ventricular systole phase. The inflatable balloon 402 can directionally inflate incrementally and / or sequentially along a longitudinal dimension of the inflatable balloon 402. For example, the inflatable balloon 402 can inflate incrementally from the first end portion 404 toward the second end portion 406 along the guidewire. Inflating the inflatable balloon 402 to provide incremental portions of the inflatable balloon 402 in the inflated state can be configured to occlude incremental portions of the lumen 452 during at least a portion of ventricular systole, to direct blood flow through the tubular member 450 from the mitral valve 6 towards the aortic valve 7. In some instances, while the inflatable balloon 402 is in the fully inflated state, the first end portion 404 of the inflatable balloon 402 can be disposed in the lumen 452 of the first end portion 454 of the tubular member 450. A second end portion 406 of the inflatable balloon 402 can be disposed in the lumen 452 of the second end portion 456 of the tubular member 450. For example, a first end of the inflatable balloon 402 can be disposed in the left atrium 2 while the inflatable balloon is inflated. A second end of the inflatable balloon 402 can be in the left ventricle 3. In some instances, a shape of the inflatable balloon 402 can conform to a shape of the lumen 452 to allow incremental occlusion of the lumen 452 as the inflatable balloon 402 is incrementally inflated. In some instances, while the inflatable balloon 402 is fully inflated, the inflatable balloon 402 assume a “U” shape. Blood from the left atrium 2 can flow through the first opening 462 of the tubular member 450 and into the lumen 452. The blood flow can be directed through the lumen 452 by the inflating inflatable balloon 402 to drive blood flow through the left ventricle 3 and towards the second opening 464 oriented towards the aortic valve 7. Black arrows in Figure 4B show the incremental inflation of the inflatable balloon 402 from the first end portion 404 to the second end portion 406. Dashed arrows in Figure 4B show the direction of blood flow through the lumen 452 as the inflatable balloon 402 is inflated incrementally.

[0072] The fluid pumping system 400 can comprise one or more other features of the fluid pumping system 200 described with reference to Figures 2 A through 2C. In some instances, remaining features of the fluid pumping system 400 can be the same as or similar to that of the fluid pumping system 200 described with reference to Figures 2A through 2C. For example, the tubular member 450 can comprise a tubular inflatable balloon 470. A multilumen inflation tube 482 can be coupled to the tubular inflatable balloon 470 and the inflatable balloon 402, respective inflation tube portions 484, 486 being in fluidcommunication with a respective portion of the inflatable balloon 402 and the tubular inflatable balloon 470 for injection and / or withdrawal of inflation fluid. In some instances, the inflatable balloon 402 can incrementally deflate. In some instances, deflation of the inflatable balloon 402 can begin after the inflatable balloon 402 assumes the fully inflated state, for example, sequentially deflating from the first end portion 404 toward the second end portion 406. Alternatively, the inflatable balloon 402 can sequentially deflate as the inflatable balloon 402 sequentially inflates. For example, respective portions of the inflatable balloon 402 can be sequentially inflated at any one time to provide occlusion of a corresponding portion of the lumen 452.

[0073] In some alternative instances, the inflatable balloon 402 can expand and / or deflate radially. For example, inflating the inflatable balloon 402 can comprise increasing a lateral dimension, such as a diameter, of the inflatable balloon 402. In some instances, the inflatable balloon 402 can deflate radially, for example along the lateral dimension. In some instances, a one-way valve can be disposed in a portion of the lumen 452 in the first end portion 454 of the tubular member 450 to allow antegrade blood flow into the lumen 452 through the first opening 462 while preventing or reducing retrograde fluid flow out of the lumen 452 through the first opening 462.

[0074] In some alternative instances, a tubular member, including one or more of the tubular members 250, 350, 450 described with reference to Figures 2A through 4B, can comprise a foldable, deformable and / or collapsible member. The tubular member can assume a folded, deformed and / or collapsed state during delivery to a target site. The tubular member can unfold and / or expand to assume an expanded state at or proximate to the target site. For example, while deployed to a heart ventricle, such as a left ventricle, the tubular member can assume the expanded state. In some instances, the tubular member can assume the folded, deformed and / or collapsed state for retraction from the target site. In some instances, a tubular member can comprise a foldable member having a tubular form defining a lumen extending therethrough. For example, a shape-memory material can form at least a portion of the tubular member. In some instances, a tubular member can comprise a deformable and / or collapsible frame and a cover over the deformable and / or collapsible frame. For example, a deformable and / or collapsible frame can form the tubular member. A cover can be over all or substantially all of the deformable and / or collapsible frame.

[0075] Fluid pumping systems similar to those depicted and described with respect to FIGS. 2A-4B could be adapted to be positioned at least partially, or even entirely, within the aorta (e.g., ascending aorta and / or aortic arch). For example, a sequentiallyinflatable balloon and corresponding tubular member could be shaped to conform to the shape of the aorta (e.g., ascending aorta and / or aortic arch), and then deployed within the aorta / ascending aorta / aortic arch, in similar deployment positions to those shown in the systems depicted in FIGS. 11A-12 herein. Such deployment may involve the entirety of the sequentially inflatable balloon and tubular member being deployed above the aortic valve, thereby preserving aortic valve function. Note that the tubular member for deployment within the aorta may comprise one or more openings therein through which blood may flow to side branching blood vessels, e.g., brachiocephalic arteries. It may be preferable for the entirely of the sequentially expandable balloon to be deployed upstream of the brachiocephalic arteries, e.g., entirely in the ascending aorta between the aortic valve and the brachiocephalic arteries. Note that in cases where aortic valve function is compromised, the sequentially inflatable balloon and / or corresponding tubular member may be positioned so as to extend over and through the aortic valve. Such an embodiment (e.g., crossing over the aortic valve) may comprises a prosthetic valve member controlling blood flow through the lumen of the tubular member, such as the valve 390 depicted and described with respect to FIGS. 3A-3B.|0076| Figure 5 is a process flow diagram of an example of a process 500 for directing blood flow through a heart ventricle to an outflow valve of the heart ventricle. In some instances, the process 500 can be performed using one or more of the fluid pumping systems 200, 300, 400 described with reference to Figures 2A through 4B. In block 502, the process can involve providing a tubular member comprising a first opening on a first end portion and a second opening on a second end portion. The tubular member can define a lumen extending through the tubular member between the first and second openings. In block 504, the process can involve providing an inflatable balloon configured to be at least partially disposed in the lumen. In block 506, the process can involve deploying the tubular member comprising the inflatable balloon at least partially disposed in the lumen to a heart. In block 508, the process can involve inflating the inflatable balloon to provide the inflatable balloon in an inflated state and occlude the lumen of the tubular member to direct blood flow through the lumen from the first opening to the second opening.

[0077] In some instances, deploying the tubular member comprising the inflatable balloon at least partially disposed in the lumen to the heart ventricle can comprise positioning the tubular member and the inflatable balloon into the left ventricle. In some instances, positioning the tubular member and the inflatable balloon into the left ventricle can comprise orienting the first end portion of the tubular member towards an apex of the heart, and orienting the second end portion of the tubular member towards the aortic valve. A first endportion of the inflatable balloon can be oriented towards the first end portion of the tubular member and a second end portion of the inflatable balloon can be oriented towards the second end portion of the tubular member. In some instances, inflating the inflatable balloon can comprise incrementally inflating the inflatable balloon from the first end portion to the second end portion of the inflatable balloon.

[0078] In some instances, deploying the tubular member comprising the inflatable balloon at least partially disposed in the lumen to the heart can comprise positioning a first end of the tubular member in a left atrium of the heart. The process can involve positioning the second end portion of the tubular member in a left ventricle of the heart, the second opening on the second end portion being oriented toward an aortic valve, a first end portion of the inflatable balloon being oriented towards the first end portion of the tubular member and a second end portion of the inflatable balloon being oriented towards the second end portion of the tubular member. In some instances, inflating the inflatable balloon can comprise incrementally inflating the inflatable balloon from the first end portion to the second end portion of the inflatable balloon.|0079| In some instances, inflating the inflatable balloon can comprise radially inflating the inflatable balloon. Radial inflation can comprise enlarging a diameter of the inflatable balloon. In some instances, providing the tubular member can comprise providing a tubular member comprising a one-way valve disposed in the lumen in the first end portion of the tubular member to prevent retrograde from the lumen while the inflatable balloon is in an inflated state.

[0080] In some instances, providing the tubular member can comprise providing a tubular inflatable balloon. In some instances, deploying the tubular member can comprise inflating the tubular inflatable balloon to an inflated state after the tubular inflatable balloon is disposed in a left ventricle of the heart. In some alternative instances, providing the tubular member can comprise providing a foldable and / or collapsible tubular member. In some instances, deploying the tubular member can comprise unfolding and / or expanding the foldable and / or collapsible tubular member to an expanded state after the foldable and / or collapsible tubular member is disposed in a left ventricle of the heart.

[0081] Figures 6A-1, 6A-2 and 6B show side views of a fluid pumping system 600 deployed to a ventricle, such as a left ventricle 3, of a heart 1. The fluid pumping system 600 can comprise an inflatable balloon 602 and a fluid guide member 650. The fluid pumping system 600 can be delivered using a transcatheter delivery approach. In some instances, a distal portion 698 of a guide wire 696 can be advanced in the left ventricle 3, such as throughan aorta 9 and aortic valve 7. A distal portion 692 of a delivery catheter 690 carrying the inflatable balloon 602 and the fluid guide member 650 can be advanced along the guidewire 696 into the left ventricle 3 through the aorta 9. In some instances, the fluid guide member 650 can be deployed from the delivery catheter 690, such as from a distal end opening 694 of the delivery catheter 690, prior to deployment of the inflatable balloon 602. The fluid guide member 650 can be disposed distally relative to the inflatable balloon 602 in the delivery catheter 690 such that the fluid guide member 650 can be deployed prior to the inflatable balloon 602. Figure 6A-1 shows the fluid guide member 650 and inflatable balloon 602 deployed into the left ventricle 3. Figure 6A-2 shows the fluid guide member 650 in further detail. The fluid guide member 650 can comprise a first surface portion 652 configured to be oriented toward, and a second surface portion 654, such as a second opposing surface, configured to be oriented away from, a leaflet of an inflow valve of the ventricle. For example, the first surface portion 652 of the fluid guide member 650 can be oriented toward an anterior leaflet of a mitral valve 6, such as a ventricular surface of the anterior leaflet. In some instances, the first surface portion 652 can be at least partially positioned against the ventricular surface of the anterior leaflet. A first end portion 656 of the fluid guide member 650 can be oriented toward the inflow valve, such as the mitral valve 6. A second end portion 658 of the fluid guide member 650 can be oriented toward the outflow valve, such as the aortic valve 7. In some instances, the fluid guide member 650 can be sized and / or shaped to be disposed over at least a portion of a ventricularly oriented surface of the anterior leaflet of the mitral valve 6. The fluid guide member 650 can be sized to extend from the aortic valve 7, including an annulus of the aortic valve 7, to a free edge of anterior leaflet.

[0082] In some instances, the fluid pumping system 600 can comprise an engagement member 680 extending from the first end portion 656, including a first end 660, of the fluid guide member 650. The engagement member 680 can facilitate coupling of the fluid guide member 650 to the leaflet. For example, the first end portion 656 of the fluid guide member 650 can be configured to be oriented toward a free edge of the leaflet. The second end portion 658 of the fluid guide member 650 can be configured to be oriented away from the free edge, such as toward an annulus of the inflow valve. In some instances, the engagement member 680 can comprise a hook 682 extending from the first end portion 656, including the first end 660, of the fluid guide member 650. The hook 682 can comprise at least a portion that folds and / or bends back over the fluid guide member 650 to clip the fluid guide member 650 to the leaflet. The hook 682 can comprise respective portions configured to be disposed around the free edge of the leaflet and over an atrial surface portion of theleaflet to clip the fluid guide member 650 of the leaflet, such as to position the fluid guide member 650 over and / or against a ventricular surface portion of the leaflet.

[0083] In some instances, the fluid guide member 650 can comprise a sheet member 664. In some instances, the sheet member 664 can form or substantially form the fluid guide member 650. For example, the sheet member 664 can form the fluid guide member 650. For example, the sheet member 664 can be a deformable, foldable and / or collapsible sheet member configured to at least partially guide blood flow from the inflow valve of the ventricle to the outflow valve of the ventricle. Figure 6A-1 shows the sheet member 664 in an expanded and / or unfolded state. In some instances, a first surface portion 666 of the sheet member 664 can be oriented toward the leaflet and a second surface portion 668 can be oriented away from the leaflet. A first end portion 670 of the sheet member 664 can be configured to be oriented toward the free edge of the leaflet of the inflow valve. A second end portion 672 can be configured to be oriented toward the outflow valve. In some instances, the second end portion 672 can engage with a portion of the heart 1 to facilitate maintaining a position of the sheet member 664, including a portion of the heart 1 between the inflow valve and the outflow valve. In some instances, the engagement member 680 can extend from the first end portion 670, including a first end 674, of the sheet member 664. A second end 676 of the sheet member 664 can be configured to engage with a portion of the heart 1 between the mitral valve 6 and the aortic valve 7. In some instances, the sheet member 664 can be sized and / or shaped to be disposed over at least a portion of a ventricularly oriented surface of the anterior leaflet of the mitral valve 6. The sheet member 664 can be sized to extend from the aortic valve 7, including an annulus of the aortic valve 7, to a free edge of anterior leaflet. In some instances, the sheet member 664 can have a planar configuration, for example the first and second surface portions 666, 668 being flat or substantially flat and opposingly oriented surface portions.

[0084] Referring to Figure 6A- 1 , the inflatable balloon 602 is shown in the deflated state. In some instances, the inflatable balloon 602 can assume the deflated state during delivery to a target site. For example, the inflatable balloon 602 can be in the deflated state during delivery to the left ventricle 3. After being positioned in the left ventricle 3, the inflatable balloon 602 can assume the deflated state during at least a portion of a ventricular diastole phase. In some instances, while disposed in the ventricle, the inflatable balloon 602 can comprise a first end portion 604 oriented toward an apex of the heart 1 and / or the mitral valve 6 and a second end portion 606 oriented toward an outflow valve of the ventricle, such as the aortic valve 7. While in the deflated state, the inflatable balloon 602 can be spacedfrom the fluid guide member 650. As described in further detail herein, the inflatable balloon 602 can be inflated incrementally from the first end portion 604 toward the second end portion 606, such as during at least a portion of a ventricular systole phase.

[0085] Figure 6B shows the inflatable balloon 602 in a fully inflated state. An inflation tube 620 can be coupled to the inflatable balloon 602 for inflation and / or deflation of the inflatable balloon 602. The inflatable balloon 602 can be incrementally inflated from the first end portion 604 toward the second end portion 606 until the inflatable balloon 602 assumes the inflated state, such as during at least a portion of the ventricular systole phase. The inflatable balloon 602 can be at a position in the left ventricle 3 to allow contact between the inflatable balloon 602 and the fluid guide member 650, such as a second surface portion 654 of the fluid guide member 650, while the inflatable balloon 602 is in the inflated state. The inflatable balloon 602 can be configured to be against at least a portion of the second surface portion 654 of the fluid guide member 650, such as while the inflatable balloon 602 is in the inflated state. The inflatable balloon 602 can be configured to be incrementally inflated from the deflated state to the inflated state along a direction from a portion oriented toward the inflow valve, such as the apex of the heart 1 and / or the mitral valve 6, to a portion oriented toward the outflow valve, such as the aortic valve 7. The inflatable balloon 602 can assume intermediate inflated states between the deflated state and the fully inflated state. In some instances, the inflatable balloon 602 can be configured to be incrementally inflated along a longitudinal dimension of the inflatable balloon 602. In some instances, corresponding portions of the inflatable balloon 602 can contact corresponding portions of the fluid guide member 650 along a direction from the first end portion 656 toward the second end portion 658. In some instances, as the inflatable balloon 602 is inflated, incremental portions of the inflatable balloon 602 can be disposed against respective portions of the fluid guide member 650, such as incrementally making contact from the first end portion 656 of the fluid guide member 650 toward the second end portion 658 of the fluid guide member 650, to direct blood flow away from the inflow valve. For example, respective portions of the inflatable balloon 602 can contact portions of the second surface portion 668 of the sheet member 664 as the inflatable balloon 602 is incrementally inflated to facilitate direction of blood flow to the aortic valve 7. In some instances, portions of the inflatable balloon 602, while in the inflated state, can have respective shapes to conform to corresponding portions of the fluid guide member 650, and / or for filling and / or conforming to a ventricular space between the fluid guide member 650 and portions of the ventricular wall. In some instances, the inflatable balloon 602 in the fully inflated state can be configured tofill or substantially fill ventricular space between the fluid guide member 650 and ventricular wall extending between an apical region of the heart 1 and the aortic valve 7. In some instances, a first surface portion 608 of the inflatable balloon 602 oriented toward the sheet member 664 can comprise a flat portion configured to be positioned against the second surface portion 668 of the sheet member 664. In some instances, a second surface portion 610 of the inflatable balloon oriented toward the ventricular wall can comprise a convex curvature. In some instances, the inflatable balloon 602 can have an elongate configuration. In some instances, the inflatable balloon 602 can taper from a larger medial portion 612 with a larger lateral cross-sectional size to first and second end portions 604, 606 having smaller lateral cross-sectional sizes. In some instances, the inflatable balloon 602 in the fully inflated state can have a crescent shape. The crescent- shaped inflatable balloon can fill or substantially fill ventricular space between the fluid guide member 650 and ventricular wall extending between an apical region of the heart 1 and the aortic valve 7. In some instances, contact between the inflatable balloon 602 in the inflated state and the fluid guide member 650, and / or filling of and / or conforming to a ventricular space between the fluid guide member 650 and portions of the ventricular wall, can facilitate augmentation and / or direction of blood flow from the mitral valve 6 to the aortic valve 7. Black arrows in Figure 6B show the direction of incremental inflation of the inflatable balloon 602. Dashed lines along respective lateral dimensions dividing the inflatable balloon 602 into respective portions in Figure 6B illustrate an example of incremental portions of the inflatable balloon 602 that can be sequentially inflated to provide the inflatable balloon 602 in the inflated state. Dashed arrows in Figure 6B show the direction of blood flow as the inflatable balloon 602 is inflated incrementally.

[0086] Figures 7A, 7B, 7C-1, 7C-2, 7D and 7E show various views of a fluid pumping system 700 deployed to a ventricle, such as a left ventricle 3, of a heart 1. The fluid pumping system 700 can comprise an inflatable balloon 702 and a fluid guide member 750. Figures 7A, 7B, 7C-1, 7C-2 and 7D show deployment of the inflatable balloon 702 and the fluid guide member 750 into the left ventricle 3. The inflatable balloon 702 of the fluid pumping system 700 can be delivered to the left ventricle 3 while in a deflated state. Figure 7E shows the inflatable balloon 702 and fluid guide member 750 disposed within the left ventricle 3 and the inflatable balloon 702 in an inflated state. Referring to Figure 7A, a distal portion 792 of a delivery catheter 790 carrying the inflatable balloon 702 and the fluid guide member 750 can be advanced into the left ventricle 3. For example, the distal portion 792 of the delivery catheter 790 can be advanced into the left ventricle 3 through an aorta 9 such thata portion of the delivery catheter 790 is disposed through an aortic valve 7. The delivery catheter 790 can be advanced along a guidewire 798 through the aorta 9 into the left ventricle 3. A nosecone 796 can extend distally from the distal portion 792 of the delivery catheter 790 and be advanced along the guidewire 798 to facilitate navigation of the delivery catheter 790.

[0087] The fluid guide member 750 can be deployed to a leaflet of an inflow valve, such as anterior leaflet of a mitral valve 6. Referring to Figure 7B, the nosecone 796 is separated from the distal portion 792 of the delivery catheter 790. An engagement member 780 can extend from a first end portion 758, such as a first end 764, of the fluid guide member 750 to couple the fluid guide member 750 to the anterior leaflet. The fluid guide member 750 can be configured to be disposed distally of the inflatable balloon 702 in the delivery catheter to allow deployment of the fluid guide member 750 prior to deployment of the inflatable balloon 702. The engagement member 780 can be deployed from the delivery catheter 790, such as through a distal end opening 794, to allow coupling of the fluid guide member 750 to the anterior leaflet. In some instances, the engagement member 780 can comprise a hook 782. The hook 782 can comprise at least a portion that folds and / or bends back over the fluid guide member 750 to clip the fluid guide member 750 to the anterior leaflet. The hook 782 can comprise respective portions configured to be disposed around a free edge and over an atrial surface portion of the anterior leaflet to clip the fluid guide member 750 to the anterior leaflet, such as to a ventricular surface portion of the anterior leaflet.

[0088] Figure 7C-1 shows the fluid guide member 750 deployed to the anterior leaflet. Figure 7C-2 shows the fluid guide member 750 in further detail. Side views of the fluid guide member 750 are shown. In some instances, the fluid guide member 750 can comprise an expandable wire frame 752. The expandable wire frame 752 can comprise a first surface portion 754 oriented toward, and a second surface portion 756 oriented away from, the anterior leaflet. A first end portion 758 of the fluid guide member 750 can be configured to be oriented toward a free edge of the leaflet. A second end portion 760 of the fluid guide member 750 can be configured to be oriented away from the free edge, such as toward an annulus of the mitral valve 6. A medial portion 762 can extend between the first and second end portions 758, 760. In some instances, respective portions of the first and second surface portions 754, 756 can form the medial portion 762. In some instances, respective portions of first and second surface portions 754, 756 can form the first and second end portions 758, 760. As described herein, the engagement member 780 extending from the first end portion 756, such as a first end 764, of the fluid guide member 750 can couple the fluid guidemember 750 to the leaflet. In some instances, respective portions of the wire frame 752 can form the first and second surface portions 754, 756, providing corresponding portions of the wire frame 752 oriented toward the anterior leaflet and the ventricle 3, and toward and away from the free edge of the anterior leaflet. For example, the engagement member 780 can extend from a portion of the wire frame 752 forming the first end portion 756. In some instances, the wire frame 752 can be sized and / or shaped to be disposed over at least a portion of a ventricularly oriented surface of the anterior leaflet, for example extending from the annulus of the mitral valve 6 to the free edge of anterior leaflet.

[0089] In some instances, the first surface portion 754 of the expandable wire frame 752 can comprise a first curved surface portion 768. In some instances, the first curved surface portion 768 can comprise a convex curve configured to be oriented toward, engage and / or be in contact with a ventricularly oriented surface portion of the anterior leaflet. In some instances, the second surface portion 756 of the expandable wire frame 752 can comprise a second curved surface portion 770. In some instances, the second curved surface portion 770 can comprise a convex curve, including a convex curve opposingly oriented relative to that of the first curved surface portion 768, configured to be oriented away from the ventricularly oriented surface portion of the anterior leaflet. In some instances, corresponding portions of the expandable wire frame 752 can form opposingly oriented convexly curved portions configured to be oriented toward and away from the anterior leaflet. In some instances, the second curved surface portion 770 can facilitate direction of blood flow toward the aortic valve. In some instances, the expandable wire frame 752 can form a narrowing taper toward the first and / or second end portions 758, 760. For example, the expandable wire frame 752 can comprise a taper from a wider medial portion 762 to narrower first and second end portions 758, 760. Alternatively, a second surface portion may not include a curved surface portion.

[0090] In some instances, the fluid guide member 750 can comprise a cover member 772 over at least the second surface portion 756 of the expandable wire frame 752. In some instances, the cover member 772 can be over both the first and second surface portions 754, 756. In some instances, the cover member 772 can be over all or substantially all of the expandable wire frame 752. As described in further detail herein, the inflatable balloon 702, while in the inflated state, can be configured to be positioned against at least a portion of the cover member 772.

[0091] In some instances, a hinge 740 can be coupled to the second end portion 760 of the expandable wire frame 752. In some instances, the hinge 740 can be coupled to asecond end 766 of the expandable wire frame 752. The hinge 740 can comprise a first portion 742 configured to be coupled to the second end portion 760, such as second end 766, of the expandable wire frame 752. A second portion 744 of the hinge 740 can be rotatable relative to the first portion 742. In some instances, the second portion 744 can be configured to engage with a portion of the heart to allow stable positioning of the fluid guide member 750, including positioning of at least a portion of the fluid guide member 750 against the anterior leaflet. In some instances, the second end portion 744 can engage a portion of the heart 1 between the anterior leaflet of the mitral valve 6 and a leaflet of the aortic valve 7. In some instances, the second end portion 744 can engage a portion of an annulus of the mitral valve 6. In some instances, the second end portion 744 can engage a portion of the heart 1 between the mitral valve 6 and the aortic valve 7. Rotation of the first and / or second portions 742, 744 relative to one another can allow the expandable wire frame 752 to move with the anterior leaflet while the expandable wire frame 752 is stably coupled to and / or at least partially positioned against to the anterior leaflet.

[0092] Figure 7D shows the inflatable balloon 702 deployed into the left ventricle 3. In some instances, the inflatable balloon 702 can be carried on the guidewire 798 proximal of the expandable wire frame 752 within the delivery catheter 790. After the expandable wire frame 752 is deployed, the inflatable balloon 702 can be positioned into the left ventricle 3. The inflatable balloon 702 can be in the deflated state during delivery to the left ventricle 3. After delivery to the left ventricle 3, the inflatable balloon 702 can be in the deflated state during at least a portion of ventricular diastole. An inflation tube 720 can be coupled to the inflatable balloon 702 for inflation and / or deflation of the inflatable balloon 702. The inflatable balloon 702 can at a position in the left ventricle 3 to allow contact between the inflatable balloon 702 and the fluid guide member 750 while the inflatable balloon 702 is in an inflated state. As described in further detail herein, respective portions of the inflatable balloon 702 can contact the fluid guide member 750 as the inflatable balloon 702 is incrementally inflated.

[0093] Figure 7E shows the inflatable balloon 702 disposed in the left ventricle 3 and in a fully inflated state. The inflatable balloon 702 comprises a first end portion 704 configured to be oriented toward an apex of the heart 1 and a second end portion 706 configured to be oriented toward the aortic valve 7. In some instances, the inflatable balloon 702 can be incrementally inflated along a longitudinal dimension of the inflatable balloon 702 to direct blood flow away from the mitral valve 6 and toward the aortic valve 7. In some instances, the inflatable balloon 702 can be configured to inflate incrementally from the firstend portion 704 toward the second end portion 706 to direct blood flow away from the mitral valve 6 and toward the aortic valve 7. Figure 7E shows dashed lines dividing the inflatable balloon 702 into three portions respectively labeled A, B and C. The portions of the inflatable balloon 902 can be inflated in sequential order from A to C. It will be understood that the inflatable balloon 702 can comprise more or fewer portions that can be sequentially inflated. The inflatable balloon 702 can assume intermediate inflated states between the deflated state and the fully inflated state.

[0094] In some instances, the inflatable balloon 702 can have a shape to conform to corresponding portions of the fluid guide member 750, and / or for filling and / or conforming to a ventricular space between the fluid guide member 750 and portions of the ventricular wall. In some instances, a surface portion of a portion of the inflatable balloon 702, such as a first surface portion 708 configured to be oriented toward the fluid guide member 750, can comprise a shape configured to conform to a shape of a corresponding portion of the cover member 772. The first surface portion 708 can assume a shape configured to conform to a shape of a corresponding portion of the cover member 772 disposed over the second surface portion 756 of the expandable wire frame 752. At least a portion of the first surface portion 708 of the inflatable balloon 702 can be positioned against the cover member 772, for example preventing or reducing blood flow therebetween. In some instances, the first surface portion 708 of the inflatable balloon 702 can comprise a concave curvature configured to engage with a curved portion of the cover member 772. In some instances, the concavity of the concave curvature can complement the convexity of the convex curvature of the fluid guide member 750 as described herein. In some instances, a second surface portion 710 of the inflatable balloon 702 oriented toward the ventricular wall can comprise a convex curvature. In some instances, the inflatable balloon 702 can have an elongate configuration. In some instances, the inflatable balloon 702 in the fully inflated state can be configured to partially fill ventricular space between the fluid guide member 750 and ventricular wall extending between an apical region of the heart 1 and the aortic valve 7. Alternatively, the inflatable balloon 702 in the fully inflated state can be configured to fill or substantially fill ventricular space between the fluid guide member 750 and ventricular wall extending between an apical region of the heart 1 and the aortic valve 7.

[0095] In some instances, the inflatable balloons 602, 702 described with refence to Figures 6A - 7E can deflate incrementally from a fully inflated state to the deflated state, including along the longitudinal dimension of the respective inflatable balloon 602, 702. For example, the inflatable balloon 602, 702 can deflate incrementally from the first end portion604, 704 toward the second end portion 606, 706. Adjacent portions of the inflatable balloon 602, 702 can sequentially deflate following the same or similar sequence as the inflation process. For example, a portion of the inflatable balloon 602, 702 that is inflated prior to another portion of the inflatable balloon 602, 702 can be deflated prior that other portion of the inflatable balloon 602, 702. Referring to Figure 7E, portion A of the inflatable balloon 702 can deflate first, followed by portion B and then C. In some instances, the inflatable balloon 602, 702 can begin deflation after all of the portions of the inflatable balloon 602, 702 are in the inflated state, for example after the fully inflated state is achieved. In some instances, portions of the inflatable balloon 602, 702 can be deflated while one or more other portions of the inflatable balloon 602, 702 are inflated, such that less than all of the inflatable balloon 602, 702 is inflated at any one time.

[0096] Inflatable balloons similar to those depicted and described with respect to FIGS. 6A-7E (e.g., balloons 602, 702) could be adapted to be positioned at least partially, or even entirely, within the aorta (e.g., ascending aorta and / or aortic arch). For example, a sequentially inflatable balloon could be shaped to conform to the shape of the aorta (e.g., ascending aorta and / or aortic arch), and then deployed within the aorta / ascending aorta / aortic arch, in similar deployment positions to those shown in the systems depicted in FIGS. 11 A- 12 herein. For example, a sequentially inflatable balloon similar to those depicted in FIGS. 6A- 7E could be shaped to conform to the shape of the ascending aorta and / or aortic arch, and then deployed within the ascending aorta and / or aortic arch, in a similar deployment position to that shown in the system depicted in FIG. 12 herein. It may be preferable for the entirely of the sequentially expandable balloon to be deployed upstream of the brachiocephalic arteries, e.g., entirely in the ascending aorta between the aortic valve and the brachiocephalic arteries. Deployment may involve the entirety of the sequentially inflatable balloon being deployed above the aortic valve, thereby preserving aortic valve function. Alternatively, such as in cases where aortic valve function is compromised, the sequentially inflatable balloon may be positioned so as to extend over and through the aortic valve.

[0097] Figure 8 is a process flow diagram of an example of a process 800 for directing blood flow through a heart ventricle. In some instances, the process 800 for directing blood flow through the heart ventricle can be performed using either of the fluid pumping systems 600, 700 described with reference to Figures 6A - 6B and 7A - 7E. In block 802, the process can involve positioning a fluid guide member in a ventricle of a heart. The fluid guide member can comprise a first surface portion oriented toward, and a second surface portion oriented away from, a leaflet of an inflow valve of the ventricle. In block 804,the process can involve positioning an inflatable balloon in the ventricle. In block 806, the process can involve inflating the inflatable balloon incrementally along a longitudinal dimension of the inflatable balloon to incrementally position respective surface portions of the inflatable balloon against the second surface portion of the fluid guide member to direct blood flow away from the inflow valve to an outflow valve of the ventricle.

[0098] In some instances, positioning the fluid guide member in the ventricle can comprise orienting a first end portion of the fluid guide member toward a free edge of the leaflet and a second end portion of the fluid guide member toward an annulus of the inflow valve. In some instances, positioning the inflatable balloon in the ventricle can comprise orienting a first end portion of the inflatable balloon away from the outflow valve and a second end portion of the inflatable balloon toward the outflow valve. For example, the first end portion of the inflatable balloon can be oriented toward an apex of the heart. Inflating the inflatable balloon incrementally can comprise inflating the inflatable balloon incrementally from its first end portion toward its second end portion. In some instances, incrementally inflating the inflatable balloon from its first end portion toward its second end portion can provide respective surface portions of the inflatable balloon against the second surface portion of the fluid guide member to direct blood flow away from the inflow valve and toward the outflow valve of the ventricle.

[0099] In some instances, positioning the fluid guide member in the ventricle can comprise coupling the fluid guide member to the leaflet. In some instances, coupling the fluid guide member to the leaflet can comprise disposing a hook coupled to the first end portion of the fluid guide member around a free edge and over an atrial surface portion of the leaflet to clip the fluid guide member to the leaflet. For example, the fluid guide member can be clipped to the leaflet such that the first surface portion of the fluid guide member can be oriented toward a ventricular surface of the leaflet.

[0100] In some instances, positioning the fluid guide member in the ventricle can comprise positioning an expandable wire frame in the ventricle. In some instances, the process can comprise providing a hinge having a first portion coupled to an end portion of the expandable wire frame configured to be oriented away from the inflow valve, and a second portion rotatable about the first portion. For example, the first portion of the hinge can be coupled to the end portion of the expandable wire frame configured to be oriented toward an annulus of the inflow valve. In some instances, the process can comprise engaging the second portion of the hinge with a portion of the heart to allow the expandable wire frame to move with the leaflet while the expandable wire frame is coupled to the leaflet. In some instances,the second portion of the hinge can engage with a portion of the heart between the inflow valve and the outflow valve of the ventricle.

[0101] In some instances, positioning the fluid guide member and the inflatable balloon in the ventricle can comprise advancing a delivery catheter carrying the fluid guide member and the inflatable balloon into a left ventricle through an aorta. In some instances, positioning the fluid guide member and the inflatable balloon in the ventricle can comprise orienting the first surface portion of the fluid guide toward a ventricular surface of an anterior leaflet of a mitral valve. In some instances, the process can comprise orienting a first end portion of the inflatable balloon toward an apex of the heart and a second end portion toward an aortic valve, such that incrementally inflating the inflatable balloon from the first end portion to the second end portion can direct blood flow away from the mitral valve and toward the aortic valve.

[0102] Figures 9A and 9B show side views of a fluid pumping system 900 deployed to a ventricle, such as a left ventricle 3, of a heart 1. The fluid pumping system 900 can comprise an inflatable balloon 902 and a guidewire 950. Figures 9A and 9B show the inflatable balloon 902 disposed around a portion of the guidewire 950, while the inflatable balloon 902 is in a deflated state and an inflated state, respectively. The guidewire 950 can comprise a first portion 952 configured to be disposed through an inflow valve of the ventricle and a second portion 954 configured to be disposed through an outflow valve of the ventricle. A medial portion 956 of the guidewire 950 can be disposed within the ventricle between the first and second portions 952, 954. The medial portion 956 can form a curvature 958 within the ventricle, for example bending between the first and second portions 952, 954. The curvature 958 can have a convex portion oriented toward an apex of the heart 1. For example, the guidewire 950 can be disposed through the left ventricle 3, the first portion 952 being disposed through a mitral valve 6, and the second portion 954 being disposed through an aortic valve 7. The medial portion 956 can form the bend in the left ventricle 3 to extend between the first and second portions 952, 954. In some instances, portions of the guidewire 950 within the ventricle can assume a “V” shape, the bend in the “V” shape pointed toward an apical region of the heart 1. In some instances, portions of the guidewire 950 within the ventricle can assume a “U” shape, the bend in the “U” shape oriented toward the apical region of the heart 1. An inflation tube 920 can be coupled to the inflatable balloon 902 for inflation and / or deflation of the inflatable balloon 902.

[0103] The inflatable balloon 902 can be configured to be disposed in the left ventricle 3 along the guidewire 950. Referring to Figure 9A, while in the deflated state,respective portions of the inflatable balloon 902 can be disposed along the guidewire 950, such as on the inflow valve side of the curvature, around the curvature 958, and on the outflow valve side of the curvature. The inflatable balloon 902 can comprise a first end portion 904 oriented toward the inflow valve and a second end portion 906 oriented toward the outflow valve. A medial portion 908 of the inflatable balloon 902 can be disposed along the curvature 958 of the guidewire 950. For example, respective portions of the inflatable balloon 902 can be disposed along the guidewire 950 on the mitral valve side of the curvature 958, around the curvature 958, and on the aortic valve side of the curvature 958. Alternatively, while the inflatable balloon 902 is in the deflated state, the inflatable balloon 902 can be disposed along the guidewire 950 on the inflow valve side of the guidewire 950 and / or around the curvature 958 of the guidewire 950. As the inflatable balloon 902 inflates, the inflatable balloon 902 can extend toward the outflow valve.

[0104] In some instances, the inflatable balloon 902 can assume the deflated state during delivery to a target site. In some instances, the inflatable balloon 902 can assume the deflated state during ventricular diastole, such as to facilitate filling of the ventricle with blood. For example, the inflatable balloon 902 can assume the deflated state during at least a portion of a ventricular diastole phase of the left ventricle 3 to facilitate flowing of oxygenated blood into the left ventricle 3.

[0105] Figure 9B shows the inflatable balloon 902 in the inflated state. The inflatable balloon 902 can assume the inflated date during at least a portion of a ventricular systole phase. The inflatable balloon 902 can be configured to be inflated incrementally to a fully inflated state. For example, the inflatable balloon 902 can be configured to be inflated incrementally from the deflated state to the fully inflated state. Portions of the inflatable balloon 902 disposed on the inflow valve side of the guidewire 950 can be inflated first, followed by portions disposed around the curvature 958 of the guide wire 950, and then portions disposed on the outflow valve side of the guidewire 950. Incremental inflation of the inflatable balloon 902 from portions disposed on the inflow valve side of the guidewire 950, to portions disposed around the curvature 958, and then portions disposed on the outflow valve side, can facilitate direction of blood flow through the heart ventricle from the inflow valve to the outflow valve, such as from the mitral valve 6 to the aortic valve 7. A sequence and / or directionality in the inflation of the portions of the inflatable balloon 902 can follow the natural blood flow path within the ventricle from the inflow valve to the outflow valve so as to sweep through the ventricle from the inflow to the outflow valve and augment blood flow to the outflow valve. For example, the sequence of inflation can follow a path so as topush and / or pump the blood flow toward the aortic valve 7, thereby improving blood flow through the left ventricle 3 and into the aorta 9.

[0106] In some instances, the inflatable balloon 902 can be configured to inflate incrementally to occupy a ventricular space from the inflow valve to the outflow valve. For example, the inflatable balloon 902 can inflate incrementally from the deflated state to the inflated state to occupy left ventricular space from the mitral valve 6 to the aortic valve 7. A shape of the inflatable balloon 902 while in the fully inflated state can be configured to conform to a shape of the ventricular space, such as during at least a portion of the ventricular systole phase. In some instances, a cross-section of the inflatable balloon 902 while in the fully inflated state can have a triangular or substantially triangular shape. For example, while the inflatable balloon 902 is in the fully inflated state, the inflatable balloon 902 can have a triangular shape with a first comer portion 910 oriented toward the mitral valve 6, a second comer portion 912 oriented toward the apex of the heart, and a third comer portion 914 oriented toward the aortic valve 7. The inflatable balloon 902 can be inflated incrementally from the first corner portion 910, to the second comer portion 912, and then to the third comer portion 914. The inflatable balloon 902 can assume intermediate inflated states. For example, the portion of the inflatable balloon 902 oriented toward the mitral valve 6 can be inflated first to form the first comer portion 910, thereby pushing blood flow away from the mitral valve 6. The inflatable balloon 902 can continue to inflate toward the portion disposed around the curvature 958 in the guidewire 950 and form the second corner portion 912. Subsequently, portions of the inflatable balloon 902 disposed on the aortic valve side of the curvature can inflate, thereby pushing blood flow toward the aortic valve 7. The third comer portion 914 can be inflated to thereby direct the blood flow toward and / or through the aortic valve 7. The dashed arrows show the flow path of the augmented blood flow through the left ventricle 3. Figure 9B shows dashed lines dividing the inflatable balloon 902 into five portions respectively labeled A, B, C, D and E. The portions of the inflatable balloon 902 can be inflated in sequential order from A to E. For example, portion “A” can be in an inflated state for a first intermediate inflated state. Portions “A” and “B” can be in inflated states for a second intermediate inflated state. Portions “A,” “B” and “C”, and portions “A,” “B,” “C” and “D,” can be inflated for a third and fourth intermediate inflated state, respectively. It will be understood that the inflatable balloon 902 can have more or fewer portions that are incrementally and / or sequentially inflated.

[0107] In some instances, the inflatable balloon 902 can be configured to deflate incrementally. In some instances, the inflatable balloon 902 can deflate along the samedirection as the inflation. For example, portions disposed on the inflow valve side of the guide wire 950 can deflate, followed by portions disposed around the curvature 958 of the guidewire 950, and then portions disposed on the outflow valve side of the guidewire 950. Adjacent portions of the inflatable balloon 902 can sequentially deflate following the same or similar sequence as the inflation process. For example, portion A of the inflatable balloon 902 can deflate first, followed by portion B. Subsequently portion C, then portion D and then portion E can deflate. The incremental deflation of the inflatable balloon 902 from the inflow valve side to the outflow valve side, such as from portions oriented toward the mitral valve 6 to portions oriented toward the aortic valve 7, can facilitate filling of the ventricle. In some instances, the inflatable balloon 902 can begin deflation after all of the portions of the inflatable balloon 902 are in the inflated state. In some instances, the inflatable balloon 902 can begin deflation before one or more remaining portions of the inflatable balloon 902 are inflated such that less than all of the inflatable balloon 902 is inflated.

[0108] In some instances, cyclical inflation and deflation of the inflatable balloons 202, 302, 402, 602, 702, 902 described with reference to Figures 2A through 9B can be synchronous or asynchronous with the heartbeat. For example, cyclical inflation and deflation of the inflatable balloons 202, 302, 402, 602, 702, 902 can be synchronized with the heartbeat to augment blood flow through the left ventricle.

[0109] Figure 10A shows a side view of an example of a cardiac piston pump 1000 comprising a tubular frame 1002 deployed to a target site and Figure 10B shows a side cross-sectional view of the cardiac piston pump 1000 at the target site. The tubular frame 1002 can comprise a first tubular branch 1004 and a second tubular branch 1020. The second tubular branch 1020 can be coupled to and be at an angle relative to the first tubular branch 1004. Figure 10A shows a portion of the tubular frame 1002 deployed into an aorta 9 to facilitate downstream flow of blood through the aorta 9, such as from a left ventricle 3 of a heart 1. A piston 1016 (shown in Figure 10B) can be disposed within the first tubular branch 1004 such that back and forth translation of the piston 1016 within the first tubular branch 1004 can provide a pumping force that pulls blood from the ascending aorta 12 into the tubular frame 1002 through the second tubular branch 1020 and then out of the tubular frame 1002 at a downstream location, such as into the aortic arch 13, respectively. In some instances, the tubular frame 1002 can be advanced to the target position through an ulnar artery or radial artery. For example, delivery of the tubular frame 1002 can comprise inserting the tubular frame 1002 through an access opening formed on the ulnar artery or radial artery and advanced along the ulnar artery or radial artery to the target site. The piston 1016 can becoupled to a drive shaft 1070 that extends proximally from the piston 1016 such that a proximal portion 1072 of the drive shaft 1070 can be coupled to an external pump 1080 configured to control movement of the piston 1016. In some instances, pumping by the cardiac piston pump 1000 can be synchronized with the heartbeat. Alternatively, pumping can be asynchronous relative to the heartbeat. For example, frequency of the movement of the piston 1016 can be adjusted to achieve a target blood flow rate.

[0110] Referring to Figure 10B, in some instances, the first tubular branch 1004 can be configured to be disposed at least partially in a brachiocephalic artery 15. In some instances, the second tubular branch 1020 can be configured to be disposed at least partially in the ascending aorta 12. The first tubular branch 1004 can define a first lumen 1014. The second tubular branch 1020 can define a second lumen 1030. The first tubular branch 1004 can have a proximal end portion 1006 and a distal end portion 1008. The second tubular branch 1020 can have a proximal end portion 1022 and a distal end portion 1024. The distal end portion 1008 of the first tubular branch 1004 can be coupled to the proximal end portion 1022 of the second tubular branch 1020. In some instances, the tubular frame 1002 can comprise a joint portion 1040 comprising the distal end portion 1008 of the first tubular branch 1004 and the proximal end portion 1022 of the second tubular branch 1020. The second lumen 1030 can be in fluid communication with the first lumen 1014.

[0111] As described herein, the first tubular branch 1004 can be at least partially disposed in the brachiocephalic artery 15. A proximal end 1010 of the first tubular branch 1004 can be disposed within the brachiocephalic artery 15. A proximal end opening 1012 at the proximal end 1010 of the first tubular branch 1004 can be disposed in the brachiocephalic artery 15. The proximal end opening 1012 can provide fluid communication between the brachiocephalic artery 15 and the first lumen 1014. As described herein, the second tubular branch 1020 can be at least partially disposed in the ascending aorta 12. A distal end 1026 of the second tubular branch 1020 can be disposed within the ascending aorta 12. A distal end opening 1028 of the second tubular branch 1020 can be disposed within the ascending aorta 12. The distal end opening 1028 can provide fluid communication between the ascending aorta 12 and the second lumen 1030. In some alternative instances, such as shown in dashed lines in Figure 10B, the distal end portion 1024 of the second tubular branch 1020 can be disposed through the aortic valve. For example, the distal end 1026 of the second tubular branch 1020 can be disposed in a left ventricle 3. The distal end opening 1028 of the second tubular branch 1020 can be disposed in the left ventricle 3 to provide fluid communication between the left ventricle 3 and the second lumen 1030.

[0112] In some instances, the piston 1016 can be disposed, and translatable back and forth, within the first lumen 1014. For example, the piston 1016 can be translated proximally and distally within the first lumen 1014 to pull blood into and push blood out of the tubular frame 1002, respectively. Translation of the piston 1016 proximally, such as away from the second tubular branch 1020, can be configured to provide a suction force within the second lumen 1030 to pull blood into the second lumen 1030. For example, blood from the left ventricle can be pulled from the left ventricle through the aortic valve into the ascending aorta, and then into the second lumen 1030 through the distal end opening 1028 of the second tubular branch 1020. Translation of the piston 1016 distally, such as toward the second tubular branch 1020, can be configured to provide a pushing force to push the blood out of the tubular frame 1002 toward the aortic branch. The cardiac piston pump 1000 can be operated synchronously or asynchronously relative to the heartbeat.

[0113] In some instances, the tubular frame 1002 can assume a two-branch configuration. Referring again to Figure 10B, in some instances, the tubular frame 1002 have a bend. For example, the tubular frame 1002 can assume an “L” shape. In some instances, the joint portion 1040 can form the bend. The acute angle and / or inner edge formed by the bend being configured to be oriented away from the aortic arch. The bend can join the first and second tubular branches 1004, 1020. In some instances, the joint portion 1040 can comprise an opening 1042 disposed in and / or oriented toward the aortic arch. For example, the opening 1042 can be on an outer edge of the bend. The opening 1042 can be opposingly oriented relative to the inner edge of the bend. The opening 1042 can provide fluid communication between the first and / or second lumens 1014, 1030 and the aorta, such as the aortic arch. In some instances, distal translation of the piston 1016 can provide force to push blood out of the tubular frame 1002 through the opening 1042 into the aortic arch, thereby facilitating downstream blood flow through the aorta.

[0114] In alternative instances, the tubular frame 1002 can comprise a third tubular branch 1050 configured to be disposed at least partially in the aortic arch. In some instances, the tubular frame 1002 can form a branched configuration, such as forming a “Y” shape. Figure 10B shows the third tubular branch 1050 in dashed lines. The third tubular branch 1050 can define a third lumen 1060. In some instances, the third tubular branch 1050 can comprise a proximal end portion 1052 coupled to the distal end portion 1008 of the first tubular branch 1004 and the proximal end portion 1022 of the second tubular branch 1020. In some instances, the third tubular branch 1050 can extend along at least a portion of the aortic arch. For example, a distal end portion 1054 of the third tubular branch 1050 can be disposedin the aortic arch. In some instances, the joint portion 1040 can comprise the distal end portion 1008 of the first tubular branch 1004, and proximal end portions 1022,1052 of the second and third tubular branches 1020, 1050. Each of the first, second and third tubular branches 1004, 1020, 1050 can form a respective branch and / or arm of the “Y” shape. The third lumen 1060 can be in fluid communication with the first and second lumens 1014, 1030. In some instances, a distal end 1056 of the third tubular branch 1050 can be configured to be disposed in the aortic arch. A distal end opening 1058 at the distal end 1056 of the third tubular branch 1050 can provide fluid communication between the third lumen 1060 and the aortic arch. Distal translation of the piston 1016 can provide force to push blood out of the tubular frame 1002 through the distal end opening 1058 and into the aortic arch to thereby facilitate downstream blood flow through the aorta.

[0115] In some instances, the piston 1016 can comprise a one-way valve configured to assume a closed state as the piston 1016 is translated away from the second tubular branch 1020 and an open state as the piston 1016 is translated toward the second tubular branch 1020. In some instances, the cardiac piston pump 1000 can comprise a oneway valve 1032 disposed within the second lumen 1030. The one-way valve 1032 in the second lumen 1030 can be configured to assume an open state to allow antegrade blood flow into the second lumen 1030, while assuming a closed state to prevent or reduce retrograde blood into the aorta and / or left heart ventricle from the second lumen 1030. For example, the one-way valve 1032 can be in the open state while the piston 1016 is translated away from the second tubular branch 1020 such that blood can be drawn into the second lumen 1030 from the left ventricle. The one-way valve 1032 can be in the closed state as the piston 1016 is translated toward the second tubular branch 1020 to prevent or reduce retrograde blood flow from the second lumen 1030 into the left ventricle. In some instances, a one-way valve 1044 can be disposed in the joint portion 1040. The one-way valve 1044 can assume an opening state to allow antegrade blood flow into the aorta through the opening 1042, and a closed state to reduce or prevent retrograde blood flow from the aorta into the tubular frame 1002. For example, the one-way valve 1044 can be disposed within the tubular frame 1002 adjacent or proximate to the opening 1042 such that antegrade blood flow, such as from the second lumen 1030, can be allowed to flow through the one-way valve 1044 and then the opening 1042, while retrograde blood flow from the aorta, such as the aortic arch, into the tubular frame 1002 through the opening 1042 is reduced or prevented.

[0116] In some instances, the tubular frame 1002 can be an integral frame. For example, the first tubular branch 1004, second tubular branch 1020 and the joint portion 1040can be an integral frame, for example forming a unitary and / or single frame. In some instances, the first tubular branch 1004, second tubular branch 1020, the joint portion 1040, and the third tubular branch 1050 can be an integral frame, for example forming a unitary and / or single frame. In some instances, one or more portions of the tubular frame 1002 can be spaced from inner wall portions of brachiocephalic artery and / or aorta. Spacing from the inner wall portions can reduce or prevent irritation at the target site. For example, the shape of the tubular frame 1002 can provide desired anchoring at the target site. In some instances, the first, second and / or third tubular branches 1004, 1020, 1050 can be spaced from respective wall portions of the brachiocephalic artery, ascending aorta, and / or aortic arch. For example, the first, second and / or third tubular branches 1004, 1020, 1050 can have outer diameters smaller than the respective blood vessels in which the tubular branches are deployed, such that blood can flow around the tubular branches.

[0117] Figures 11 A, 1 IB and 11C provide various side views of an example of a cardiac piston pump 1100. Figure 11 A provides a side view of the cardiac piston pump 1100 deployed to an aorta, such as a descending aorta 14. The cardiac piston pump 1100 can be deployed using a minimally invasive technique, such as through an access site formed on a femoral artery. The cardiac piston pump 1 100 can comprise a frame 1102. The frame 1102 can comprise a distal end portion 1106 configured to have an upstream orientation and a proximal end portion 1104 configured to have a downstream orientation. The cardiac piston pump 1100 can comprise a foldable membrane 1120 coupled to the distal end portion 1106 of the frame 1102. A one-way valve 1150 can be coupled to a distal end portion 1124 of the foldable membrane 1120 such that the foldable membrane 1120 can be folded to move and / or translate the one-way valve 1150 toward the frame 1102 and unfolded to move and / or translate the one-way valve 1150 away from the frame 1102. Figures 1 IB and 11C provide side views of the cardiac piston pump 1100 where the foldable membrane 1120 is folded over itself to move and / or translate the one-way valve 1150 toward the frame 1102. Movement and / or translation of the one-way valve 1150 toward the frame 1102 can facilitate downstream blood flow away from a left ventricle and through an aorta, including the descending aorta 14.

[0118] Referring to Figure 11 A, the distal end portion 1 106 of the frame 1102 can have an upstream orientation. The proximal end portion 1104 can have a downstream orientation. In some instances, the frame 1102 can define a first lumen 1108 extending therethrough. For example, an inner surface 1110 of the frame 1102 can define at least a portion of the first lumen 1108. The first lumen 1108 can extend along a longitudinal axis ofthe frame 1102, such as extending through the frame 1102 from the proximal end portion1104 to the distal end portion 1106. At least a portion of the frame 1102 can assume a tubular configuration. In some instances, the frame 1102 can comprise at least a portion that assumes a cylindrical shape. In some instances, the foldable membrane 1120 can comprise a tubular configuration. In some instances, the foldable member 1120 can comprise at least a portion that assumes a cylindrical shape while the foldable member 1120 is in a fully unfolded configuration. In some instances, the foldable member 1120 can comprise at least a portion that assumes a truncated cone shape. For example, while the foldable member 1120 is in the fully unfolded configuration, the distal end portion 1224 can have a lateral dimension smaller than that of the proximal end portion 1222 of the foldable membrane 1220. The lateral dimension can be perpendicular or substantially perpendicular to the longitudinal axis. The truncated cone shape can facilitate folding down of the foldable member 1120 back onto itself. The foldable membrane 1120, such as a proximal end portion 1122 of the foldable membrane 1120, can be circumferentially coupled to the distal end portion 1106 of the frame 1102. The foldable membrane 1120 can define a second lumen 1126. For example, while the foldable membrane is in the unfolded configuration, an inner surface portion 1128 of the foldable membrane 1120 can at least partially define the second lumen 1126. The second lumen 1126 can be coaxial with the first lumen 1108.

[0119] The one-way valve 1150 can be circumferentially coupled to the distal end portion 1124 of the foldable membrane 1120. The one-way valve 1150 can comprise any number of unidirectional valves configured to allow fluid flow through the valve in one direction while reducing or preventing fluid flow in the opposite direction. In some instances, the one-way valve 1150 can comprise a duckbill valve. In some instances, the one-way valve 1150 can be aligned with the longitudinal axis of the frame 1102. As described herein, the foldable membrane 1120 can be folded to move and / or translate the one-way valve 1150 toward the frame 1102. The foldable membrane 1 120 can unfold to move and / or translate the one-way valve 1150 away from the frame 1102. The one-way valve 1150 can assume an open state as the one-way valve 1150 is moved and / or translated distally away from the frame 1102, such as along an upstream direction. Blood can flow through the one-way valve 1150 and into the first and second lumens 1108, 1126 as the one-way valve 1150 is moved and / or translated away from the frame 1102. The one-way valve 1150 can assume a closed state as the one-way valve 1150 is moved and / or translated proximally toward the frame 1102, such as along a downstream direction. The one-way valve 1150 maintaining the closed state as it is moved along the downstream direction can facilitate downstream flow of the blood throughthe aorta and away from the left ventricle. Proximal movement and / or translation of the oneway valve 1150 toward the frame 1102 in the closed state can push blood in the first and second lumens 1108, 1126 downstream, for example pumping blood downstream through the aorta.

[0120] Figure 11 A shows the foldable membrane 1120 in an unfolded configuration, for example in a fully unfolded state, such that the one-way valve 1150 can be at a distal-most position relative to the frame 1102. The one-way valve 1150 can be disposed in a most upstream position. In some instances, the one-way valve 1150 can be disposed in the descending aorta while the foldable membrane 1120 is in the fully unfolded configuration. In some instances, the one-way valve 1150 can be in the open state while the one-way valve 1150 is in the distal most and / or most upstream position. Figures 1 IB and 11C show the foldable membrane 1120 in various folded states. Portions of the foldable membrane 1120 can fold back onto itself to translate the one-way valve 1150 along the longitudinal axis of the toward the frame 1102. The distal end portion 1124 of the foldable membrane 1120 can be folded back onto remainder portions of the foldable membrane 1120 to assume various folded states. Portions of the inner surface 1128 of the foldable member 1 120 can be configured to be oriented toward one another, while a portion of an outer surface 1130 of the foldable member 1120 can be oriented toward the second lumen 1126. Figure 1 IB shows the foldable membrane 1120 in a partially folded state. For example, the one-way valve 1150 can be disposed in the second lumen 1126 while the foldable membrane 1120 is in the partially folded state. Figure 1 1C shows the foldable membrane 1120 is in a fully folded state, for example in a folded configuration, such that the one-way valve 1150 is in a proximal-most position relative to the frame 1102. In some instances, the distal and proximal end portions 1122, 1124 of the foldable membrane 1120 can be proximate and / or adjacent to one another while the foldable membrane 1120 is in the fully folded configuration. In some instances, the one-way valve 1150 can be configured to be at least partially disposed in the first lumen 1108 with the foldable membrane 1120 in the fully folded configuration and the one-way valve 1150 in the proximal-most position. In some instances, the one-way valve 1150 can be in the open state while the one-way valve 1150 is in the proximal-most position.

[0121] In some instances, the cardiac piston pump 1100 can comprise a drive shaft 1160 coupled to the one-way valve 1150 for moving and / or translating the one-way valve 1150 away from and toward the frame 1102. Respective portions of the drive shaft 1160 can extend through the first lumen 1108 and / or second lumen 1126. The drive shaft 1160 can be advanced and / or retracted, such as relative to the frame 1102, to move and / ortranslate the one-way valve 1150 distally and / or proximally, respectively. In some instances, the cardiac piston pump 1100 can comprise a plurality of support struts 1180 coupling a distal end portion 1164 of the drive shaft 1160 and the one-way valve 1 150. The plurality of support struts 1180 can be configured to facilitate translation of the one-way valve 1150. In some instances, an atraumatic nosecone 1170 can be coupled to a distal end 1166 of the drive shaft 1160. The atraumatic nosecone 1170 can be configured to reduce or prevent contact injury to any aortic wall portions due to movement of the drive shaft 1160. The drive shaft 1 160 can extend proximally and be coupled to an externally positioned controller 1176. For example, a proximal portion 1162 of the drive shaft 1160 can be externally disposed and coupled to the controller 1176.

[0122] In some instances, the cardiac piston pump 1100 can comprise a sealing membrane 1190 disposed at least partially circumferentially around the frame 1102. The sealing membrane 1190 can be over and / or in contact with an outer surface 1112 of the frame 1102. In some instances, the sealing membrane 1190 can be circumferentially disposed around at least a portion of the frame 1102, such as a portion of the outer surface 1112 of the frame 1102. The sealing membrane 1190 can be over portions of the outer surface 1112 configured to be oriented toward the descending aorta 14. The sealing membrane 1190, such as an externally oriented surface 1192 of the sealing membrane 1190, can be configured to engage with respective wall portions of the aorta and provide a seal around the frame 1102 with respective wall portions of the aorta.

[0123] In some instances, the frame 1102 can comprise an expandable frame. In some instances, at least a portion of the expandable frame can assume a cylindrical shape in a deployed state. For example, the frame 1102 can be disposed at or adjacent to the target site in the descending aorta while the frame 1102 is in a collapsed state. The frame 1102 can subsequently expand to assume the deployed state after being positioned at the target site. For example, a delivery catheter 1172 carrying the frame 1102 in the collapsed state can be advanced within an access sheath 1174 to position the frame 1102 in the collapsed state at or proximate to the target site. The frame 1102 can be subsequently released from the delivery catheter 1172. After release from the delivery catheter 1172, the frame 1102 can assume the deployed state. The frame 1102 in the collapsed state can have a lateral dimension, such as a diameter, smaller than that in the deployed state. In some instances, at least a portion of the frame 1102 can assume a cylindrical shape in the expanded state. In some instances, the frame 1102 may not be fully expanded while in the deployed state, such as to facilitate retraction of the frame 1102. For example, the frame 1102 can expand from the collapsedstate to a wider configuration without assuming a widest configuration while deployed in the aorta.

[0124] In some instances, the frame 1102 and / or the foldable membrane 1120 can have an outer diameter configured to engage with inner wall portions of the aorta. In some instances, the frame 1102 and / or the foldable membrane 1120 can have an outer diameter of about 1 centimeters (cm) to about 5 centimeters (cm), including about 2 centimeters (cm) to about 4 centimeters (cm), and about 2 centimeters (cm) to about 3 centimeters (cm). In some instances, cardiac piston pump 1 100 can have a stroke distance of about 1 centimeter (cm) to about 15 centimeters (cm), including about 2 centimeters (cm) to about 10 centimeters (cm), about 2 centimeters (cm) to about 5 centimeters (cm), about 3 centimeters (cm) to about 4 centimeters (cm), including about 3.5 centimeters (cm). In some instances, the cardiac piston pump 1100 can have a pump frequency of up to about 10 hertz (Hz), including about 0.5 hertz (Hz) to about 10 hertz (Hz), about 0.5 hertz (Hz) to about 5 hertz (Hz), about 1 hertz (Hz) to about 4 hertz (Hz), including about 2 hertz (Hz). In some instances, cardiac piston pump 1100 can have a stroke distance of about 9 centimeters (cm) to about 11 centimeters (cm), including about 10 centimeters (cm). In some instances, the cardiac piston pump 1100 can have a pump frequency of up to about 1 hertz (Hz). In some instances, the cardiac piston pump 1100 can provide a flow of up to about 5 liters / min (L / min), including about 0.5 liters / min (L / min) to about 5 liters / min (L / min), about 2 liters / min (L / min) to about 5 liters / min (L / min), and about 3 liters / min (L / min). The cardiac piston pump 1100 can be operated asynchronously or synchronously relative to the heartbeat.

[0125] Figure 12 provides a side view of an example of a cardiac piston pump 1200 at least partially disposed within an ascending aorta 12. The cardiac piston pump 1200 can be sized and / or shaped for deploying to the ascending aorta 12 such that the cardiac piston pump 1200 does not occlude any arteries branching from an aortic arch 13. The cardiac piston pump 1200 can comprise a frame 1202 having a distal end portion 1206 configured to have an upstream orientation and a proximal end portion 1204 configured to have a downstream orientation. A foldable membrane 1220, such as a proximal end portion 1222 of the foldable membrane 1220, can be coupled to the distal end portion 1206 of the frame 1202. A one-way valve 1250 can be coupled to a distal end portion 1224 of the foldable membrane 1220 such that the foldable membrane 1220 can be folded to move and / or translate the one-way valve 1250 toward the frame 1202 and unfolded to move and / or translate the one-way valve 1250 away from the frame 1202. Figure 12 shows the foldable membrane 1220 in an unfolded configuration, such as a fully unfolded state. For example, thedistal end portion 1224 of the foldable membrane 1220 can be disposed in the ascending aorta 12. In some instances, the cardiac piston pump 1200 can be sized such that the frame 1202 is at least partially disposed in the aortic arch 13 without occluding blood flow into arteries branching from the aortic arch 13. For example, a proximal end portion 1204 of the frame 1202 can be disposed in the aortic arch 13 without occluding blood flow into the arteries branching from the aortic arch 13. A sealing membrane 1290 can be disposed at least partially circumferentially around the frame 1202, including over and / or in contact with an outer surface 1212 of the frame 1202. The sealing membrane 1290 can be over a portion of the frame 1202 that is distal of the openings of the arteries branching from the aortic arch 13. An outer surface 1292 of the sealing membrane 1290 can facilitate engagement between the frame 1202 and inner wall portions of the aorta, such as the ascending aorta 13, including forming a seal around the frame 1202. The sealing membrane 1290 can be configured to be disposed upstream of the carotid arteries to avoid interference with blood flow into the carotid arteries.

[0126] In some instances, the frame 1202 and / or the foldable membrane 1220 can have an outer diameter configured to engage with inner wall portions of the aorta. In some instances, the frame 1202 and / or the foldable membrane 1220 can have an outer diameter of about 1 centimeters (cm) to about 5 centimeters (cm), including about 2 centimeters (cm) to about 4 centimeters (cm), and about 2 centimeters (cm) to about 3 centimeters (cm). In some instances, cardiac piston pump 1200 can have a stroke distance of about 1 centimeter (cm) to about 15 centimeters (cm), including about 2 centimeters (cm) to about 10 centimeters (cm), about 2 centimeters (cm) to about 5 centimeters (cm), about 3 centimeters (cm) to about 4 centimeters (cm), including about 3.5 centimeters (cm). In some instances, the cardiac piston pump 1200 can have a pump frequency of up to about 10 hertz (Hz), including about 0.5 hertz (Hz) to about 10 hertz (Hz), about 0.5 hertz (Hz) to about 5 hertz (Hz), about 1 hertz (Hz) to about 4 hertz (Hz), including about 2 hertz (Hz). In some instances, the cardiac piston pump 1200 can provide a flow of up to about 5 liters / min (L / min), including about 0.5 liters / min (L / min) to about 5 liters / min (L / min), about 2 liters / min (L / min) to about 5 liters / min (L / min), and about 3 liters / min (L / min). The cardiac piston pump 1200 can be operated asynchronously or synchronously relative to the heartbeat.

[0127] The cardiac piston pump 1200 can have one or more other features of the cardiac piston pump 1100 described with reference to Figures 11 A, 1 IB and 11C. In some instances, the cardiac piston pump 1200 can comprise features of the cardiac piston pump 1100 described with reference to Figures 11 A, 1 IB and 11C, while being sized and / or shapedfor deployment to the ascending aorta and aortic arch. For example, the cardiac piston pump 1200 can comprise a drive shaft 1260 coupled to the one-way valve 1250 for moving and / or translating the one-way valve 1250 away from and toward the frame 1202. The drive shaft 1260 can extend proximally through a second lumen 1226 defined by the foldable membrane 1220 and the first lumen 1208 defined by the frame 1202. A proximal end portion 1262 of the drive shaft 1260 can be coupled to an external controller 1276. A plurality of support struts 1280 can couple a distal end portion 1264 of the drive shaft 1160 and the one-way valve 1250. Tn some instances, an atraumatic nosecone 1270 can he coupled to a distal end 1266 of the drive shaft 1260. In some instances, the frame 1202 can comprise an expandable frame such that the frame 1202 can assume a collapsed state while carried by a delivery catheter 1272 that can be advanced within an access sheath 1274 to a target site. The frame 1202 can be subsequently released from the delivery catheter 1272. After release from the delivery catheter 1272, the frame 1202 can assume an expanded state for positioning at the target site.

[0128] Figures 13A, 13B and 13C show various views of an example of a cardiac piston pump 1300 deployed to an aorta, such as a descending aorta 14. The cardiac piston pump 1300 can comprise a frame 1302. A proximal end portion 1304 of the frame 1302 can have a downstream orientation while a distal end portion 1306 of the frame 1302 can have an upstream orientation. A foldable membrane 1320 can be coupled to the distal end portion 1306 of the frame 1302. A one-way valve 1350 can be coupled to a distal end portion 1324 of the foldable membrane 1320. A proximal end portion 1322 of the foldable membrane 1320 can be coupled to the distal end portion 1 06 of the frame 1302. Figure 13A is a side view of the cardiac piston pump 1300 while the foldable membrane 1320 is in an unfolded configuration, such as in a completely unfolded state. Figures 13B and 13C are side views of the cardiac piston pump 1300 while the foldable membrane 1330 are in various folded states to move the one-way valve 1350 toward the frame 1302.

[0129] Referring to Figure 13 A, in some instances, the foldable membrane 1320 can comprise a truncated conical configuration, such as while the foldable membrane 1320 is in the fully unfolded configuration. For example, the foldable membrane 1320 can assume a truncated conical shape while fully unfolded. The one-way valve 1350 can be in a distal-most position, such as a most upstream position, while the foldable membrane 1320 is in the unfolded configuration. While the foldable membrane 1320 is in the unfolded configuration, the distal end portion 1324 of the foldable membrane 1320 can have a lateral dimension smaller than that of the proximal end portion 1322 of the foldable membrane 1320. In some instances, the tapering of the lateral dimension of the foldable membrane 1320 from theproximal end portion 1322 toward the distal end portion 1324 can facilitate folding of the foldable membrane 1320. The lateral dimension can be perpendicular or substantially perpendicular to a longitudinal axis of the foldable membrane 1320 extending between the proximal end portion 1322 and the distal end portion 1324. The frame 1302, such as an inner surface 1310 of the frame 1302, can define a first lumen 1326 extending at least along a portion of a longitudinal dimension of the frame 1302. The longitudinal dimension can be along a longitudinal axis extending between first and second end portions of frame 1302, for example being coaxial with a longitudinal axis of the foldable membrane 1320. An outer surface portion 1312 can be oriented toward and / or engage with inner wall portions of the descending aorta 14. The foldable membrane 1320, such as an inner surface 1328 of the foldable membrane 1320, can define a second lumen 1326 extending at least along a portion of a longitudinal dimension of the frame foldable membrane 1320. The second lumen 1326 can be coaxial with the first lumen 1308. Proximal translation, such as downstream translation, of the one-way valve 1350 can facilitate pushing blood downstream through the second and first lumens 1308, 1326.|0130| Respective portions of a drive shaft 1360 can extend through the first and second lumens 1308, 1326 and be coupled to the one-way valve 1350. For example, a distal end portion 1364 of the drive shaft 1360 can be coupled to the one-way valve 1350. In some instances, the one-way valve 1350 can comprise a mesh cone 1352. The distal end portion 1364 of the drive shaft 1360 can be coupled to the mesh cone 1352. A larger end portion 1354 of the mesh cone 1352 can be coupled to the distal end portion 1324 of the foldable membrane 1320. Referring to Figure 13A, a smaller end portion 1356 of the mesh cone 1352 can be oriented distally, away from the foldable membrane 1320, while the foldable membrane 1320 is in the fully unfolded configuration. The drive shaft 1360 can be retracted to translate the mesh cone 1352 proximally. In some instances, the drive shaft 1360 can be coupled to the small end portion 1356 of the mesh cone 1352 such that retracting the drive shaft 1360 can pull at least a portion of the mesh cone 1352 into the second lumen 1326. The smaller end portion 1354 of the mesh cone 1352 can fold proximally toward the frame 1302. Referring to Figure 13B, the smaller end portion 1356 of the mesh cone 1352 can be proximally oriented as the drive shaft 1360 is retracted and the foldable membrane 1320 is folded to move the mesh cone 1352 toward the frame 1302. For example, as the drive shaft 1360 is retracted, the mesh cone 1352 can be at least partially pulled into the second lumen 1326 as the drive shaft 1360 pulls on the smaller end portion 1354. As the drive shaft 1360 is retracted further, the foldable membrane 1320 can fold back onto itself. Figure 13C shows thefoldable membrane 1320 in a folded configuration, such as in a fully folded state. Figure 13C shows the one-way valve 1350 in a proximal-most position. In some instances, while the foldable membrane 1320 is in the fully folded configuration, at least a portion of the mesh cone 1352 can be disposed within the first lumen 1308. In some instances, the smaller end portion 1354 of the mesh cone 1352 can be disposed within the first lumen 1308 while the foldable membrane 1320 is in the fully folded configuration.

[0131] In some instances, the one-way valve 1350 can comprise a covering 1390 configured to be disposed over surface portions of the mesh cone 1352 oriented towards the first and / or second lumen 1308, 1326. For example, the covering 1390 can be over internally oriented surface portions of the mesh cone 1352. The covering 1390 can be disposed over and / or be in contact with the mesh cone 1352 while the mesh cone 1352 is translated proximally, such as downstream, toward the frame 1302, so as to provide the one-way valve 1350 in a closed state. The covering 1390 can comprise a first portion 1392 oriented toward and / or coupled to the larger end portion 1354 of the mesh cone 1352. A second portion 1394 of the covering 1390 can be disposed over the smaller end portion 1356 of the mesh cone 1352. The covering 1390 can move away from the mesh cone 1352 while the mesh cone 1352 is translated distally, such as upstream, away from the frame 1302 so as to provide the one-way valve 1350 in an open state. For example, the covering 1390 can pivot away from the mesh cone 1352, such as around a rotatable coupling between the first portion 1392 and the mesh cone 1352, to provide the one-way valve in the open state. In some instances, the covering 1390 can comprise a plurality of discrete portions each configured to be disposed over respective portions of the mesh cone 1352. For example, the covering 1390 can comprise a plurality of discrete triangular or substantially triangular portions each having a side coupled to the larger end portion 1354 of the mesh cone 1352 and a comer oriented toward the smaller end portion 1356 of the mesh cone 1352. Each of the discrete triangular or substantially triangular portions can pivot away or toward the mesh cone 1352. In some instances, while the one-way valve 1350 is in the distal-most position, the one-way valve 1350 can be in the closed state. The distal portion 1394 of the covering 1390 can pivot toward the mesh cone 1352 around the proximal portion 1392 to provide the one-way valve 1350 in the closed state. In some instances, while the one-way valve 1350 is in the proximal-most position, the one-way valve 1350 can be in the open state.

[0132] The cardiac piston pump 1300 can comprise one or more other features of the cardiac piston pump 1100 described with reference to Figures 11 A, 1 IB and 11C. For example, an atraumatic nosecone 1370 can be coupled to a distal end 1366 of the drive shaft1360. A proximal portion 1362 of the drive shaft 1360 can be externally disposed and coupled to an externally disposed controller 1376. In some instances, the frame 1302 can comprise an expandable frame. A delivery catheter 1372 carrying the frame 1302 in a collapsed state can be advanced within an access sheath 1374 to position the frame 1302 in the collapsed state at or proximate to the target site. The frame 1302 can be subsequently released from the delivery catheter 1372 and expand to assume the deployed state. Although not shown in Figures 13A, 13B, 13C, the cardiac piston pump 1300 can comprise a sealing membrane disposed at least partially circumferentially around the frame 1302 and configured to engage and / or seal with respective wall portions of the aorta.

[0133] In some instances, the frame 1302 and / or the foldable membrane 1320 can have an outer diameter configured to engage with inner wall portions of the aorta. In some instances, the frame 1302 and / or the foldable membrane 1320 can have a widest outer diameter of about 1 centimeter (cm) to about 5 centimeters (cm), including about 2 centimeters (cm) to about 4 centimeters (cm), and about 2 centimeters (cm) to about 3 centimeters (cm). In some instances, cardiac piston pump 1300 can have a stroke distance of about 1 centimeter (cm) to about 15 centimeters (cm), including about 2 centimeters (cm) to about 10 centimeters (cm), about 2 centimeters (cm) to about 5 centimeters (cm), about 3 centimeters (cm) to about 4 centimeters (cm), including about 3.5 centimeters (cm). In some instances, the cardiac piston pump 1300 can have a pump frequency of up to about 10 hertz (Hz), including about 0.5 hertz (Hz) to about 10 hertz (Hz), about 0.5 hertz (Hz) to about 5 hertz (Hz), about 1 hertz (Hz) to about 4 hertz (Hz), including about 2 hertz (Hz). In some instances, the cardiac piston pump 1300 can provide a flow of up to about 5 liters / min (L / min), including about 0.5 liters / min (L / min) to about 5 liters / min (L / min), about 2 liters / min (L / min) to about 5 liters / min (L / min), and about 3 liters / min (L / min). In some instances, cardiac piston pump 1300 can have a stroke distance of about 9 centimeters (cm) to about 11 centimeters (cm), including about 10 centimeters (cm). In some instances, the cardiac piston pump 1300 can have a pump frequency of up to about 1 hertz (Hz). The cardiac piston pump 1300 can be operated asynchronously or synchronously relative to the heartbeat.

[0134] Figures 14A through 14E show various views of an example of a cardiac peristaltic pump 1400. The cardiac peristaltic pump 1400 can comprise a plurality of inflatable balloons, such as first, second and third inflatable balloons 1470, 1480, 1490, disposed around an outer tubular member 1402, and an inner tubular member 1430 disposed within and rotatable relative to the outer tubular member 1402. Figure 14A shows theplurality of inflatable balloons, outer tubular member 1402, and inner tubular member 1430 deployed to a target position in an aorta, including a descending aorta 14. The cardiac peristaltic pump 1400 can be deployed using a minimally invasive procedure, such as through an access site on a femoral artery. Figures 14B, 14C and 14D provide side views of the cardiac peristaltic pump 1400 showing sequential inflation and / or deflation of the plurality of inflatable balloons. Figure 14E provides a side cross-sectional view of the cardiac peristaltic pump 1400. Each of the plurality of inflatable balloons 1470, 1480, 1490 can be configured to occlude a respective portion of the aorta in its inflated state. Sequential inflation of the plurality of inflatable balloons 1470, 1480, 1490, such as along a distal to proximal direction, can be configured to push blood downstream through the aorta, including the descending aorta.

[0135] Referring to Figures 14A and 14E, the outer tubular member 1402 can define a first lumen 1408. For example, the first lumen 1408 can extend along a longitudinal axis of the outer tubular member 1402, including from a proximal end portion 1404 to a distal end portion 1406 of the outer tubular member 1402. In some instances, the outer tubular member 1402 can assume a cylindrical shape. The outer tubular member 1402 can comprise a first plurality of openings, such as a first opening 1420, second opening 1422 and third opening 1424. The first plurality of openings can extend through respective portions of a wall portion 1410 at least partially forming the outer tubular member 1402. For example, the wall portion 1410 can assume a cylindrical shape. An inner surface 1412 of the wall portion 1410 can at least partially define the first lumen 1408. The first, second and third openings 1420, 1422, 1424 can be at a respective positions along a longitudinal dimension of the outer tubular member 1402.

[0136] Each of the plurality of inflatable balloons, such as the first, second and third inflatable balloons 1470, 1480, 1490, can be disposed at a respective circumferential position around the outer tubular member 1402. For example, the first, second, third inflatable balloons 1470, 1480, 1490 can be disposed over an outer surface 1414 of the wall portion 1410. In some instances, the first, second and third inflatable balloons 1470, 1480, 1490 can form a series of toroid inflatable balloons along the longitudinal dimension of the outer tubular member 1402. In some instances, the first, second and third inflatable balloons 1470, 1480, 1490 can comprise a flexible and / or expandable membrane portions 1472, 1482, 1492 coupled to the outer tubular member 1402. Each of the inflatable balloons 1470, 1480, 1490 can be aligned with a respective one of the plurality of first openings such that the inflatable balloons 1470, 1480, 1490 can be in fluid communication with the first lumen1408. For example, the first inflatable balloon 1470 can be aligned with the first opening 1420. The second inflatable balloon 1480 can be aligned with the second opening 1422. The third inflatable balloon 1490 can be aligned with the third opening 1424.

[0137] The inner tubular member 1430 can be configured to be at least partially disposed in the first lumen 1408. The inner tubular member 1430 can define a second lumen 1436. The second lumen 1436 can extend along a longitudinal axis of the inner tubular member 1430, including from a proximal end portion 1432 to a distal end portion 1434 of the inner tubular member 1430. In some instances, the inner tubular member 1430 can have a cylindrical shape. The longitudinal axes of the inner and outer tubular members 1402, 1430 can be coaxial and / or aligned. The inner tubular member 1430 can comprise a second plurality of openings, such as first, second and third openings 1450, 1452, 1454. Each of the second plurality of openings can be at a respective position along a longitudinal dimension of the inner tubular member 1430. The second plurality of openings can extend through respective portions of a wall portion 1438 forming the second tubular member 1430. For example, the wall portion 1438 can assume a cylindrical shape. An inner surface 1440 of the wall portion 1438 can at least partially define the second lumen 1436. The inner and outer tubular members 1402, 1430 can each be coupled to a first catheter 1462 and second catheter 1464, respectively, configured to be coupled to an external pump 1466 to facilitate inflation and / or deflation of the inflatable balloons. The first and second catheters 1462, 1464 can extend proximally to couple to the external pump 1466. For example, the first catheter 1462 can be configured to supply the inflation fluid into the second lumen 1436.

[0138] The inner tubular member 1430 can be rotatable, such as about its longitudinal axis, relative to the outer tubular member 1402. In some instances, the outer tubular member 1402 can comprise a protrusion 1418 configured to provide a space and / or gap between a distal end 1416 of the outer tubular member 1402 and a distal end 1444 of the inner tubular member 1430, such as to facilitate rotation of the inner tubular member 1430. Respective ones of the first and second plurality of openings can be configured to sequentially align as the inner tubular member 1430 is rotated relative to the outer tubular member 1402. In some instances, the first plurality of openings can be arranged linearly or substantially linearly along at least a portion of the longitudinal dimension of the outer tubular member 1402. For example, the first, second, and third openings 1420, 1422, 1424 can be at a respective position along a line extending along a longitudinal dimension of the outer tubular member 1402. Adjacent ones of the second plurality of openings can be laterally offset from one another along a longitudinal dimension of the inner tubular member1430. In some instances, each of the second plurality of openings can be arranged in a spiral pattern around the inner tubular member 1430. For example, the first, second and third openings 1450, 1452, 1454 can be along at least a partial spiral around the inner tubular member 1430.

[0139] Alignment of corresponding ones of the first and second plurality of openings can provide fluid communication between the respective inflatable balloon and the second lumen 1436. Inflation fluid, including an inflation gas, can be flowed into the second lumen 1436 and through respective ones of the second plurality of openings, and first plurality of openings of the outer tubular member 1402, to allow inflation of the inflatable balloons 1470, 1480, 1490. Sequential alignment of respective ones of the first and second plurality of openings can allow inflation fluid from the second lumen 1436 to sequentially inflate the first, second and third inflatable balloons 1470, 1480, 1490. Figure 14E shows first openings 1420, 1450 of the first and second plurality of openings aligned with one another. The first inflatable balloon 1470 can be inflated as inflation fluid passes from the second lumen 1436 through the first openings 1420, 1450 into the first inflatable balloon 1470. Alternatively, a plurality of openings on the outer tubular member 1402 can be aligned with a respective plurality of openings on the inner tubular member 1430 for inflation of each of the inflatable balloons 1470, 1480, 1490.

[0140] In some instances, the plurality of inflatable balloons can be configured to be sequentially deflated. In some instances, an outer lateral dimension, such as an outer diameter, of the inner tubular member 1430 can be smaller than a lateral dimension of the first lumen 1408, such as a diameter of the first lumen 1408, so as to provide a gap 1460 between the inner and outer tubular members 1402, 1430. The gap 1460 can provide a leak path for the inflation fluid. For example, the gap 1460 can be provided between an outer surface of the inner tubular member 1430, such as an outer surface 1442 of the wall portion 1438, and the inner surface of the outer tubular member 1402, such as the inner surface 1412 of the wall portion 1410. The gap 1460 can be configured to allow passage of inflation fluid from an inflated inflatable balloon into the first lumen 1408 as respective ones of the plurality of first and second plurality of openings rotate out of alignment with one another. Escape of inflation through a can facilitate deflation of the inflatable balloon. Figure 14E shows the second openings 1422, 1452 and third openings 1424, 1454 of the first and second plurality of openings out of alignment. Any inflation fluid in the second and third inflatable balloons 1480, 1490 can flow through the second and third openings 1422, 1452, 1424, 1454 of the first and second plurality of openings and into the gap 1460 between the first and secondtubular members 1402, 1430. The second and third inflatable balloons 1480, 1490 can be in deflated states while the first inflatable balloon 1470 is inflated.

[0141] Referring to Figures 14B, 14C and 14D, side views of the cardiac peristaltic pump 1400 are provided to show sequential inflation of the first, second and third inflatable balloons 1470, 1480, 1490 from a distal most inflatable balloon to a proximal most inflatable balloon. As described herein, sequential inflation of the first, second and third inflatable balloons 1470, 1480, 1490 from the distal most to the proximal most inflatable balloon can provide a pumping force to push blood in a downstream direction in the aorta. Referring to Figure 14B, a first opening 1420 of the first plurality of openings on the outer tubular member 1402 can be aligned with a first opening 1450 of the second plurality of openings on the inner tubular member 1430. The first inflatable balloon 1470 can thereby be inflated as inflation fluid flows from the second lumen 1436 through the first openings 1420, 1450 into the first inflatable balloon 1470. The second and third inflatable balloons 1480, 1490 remain in a deflated state. Figure 14C shows the inner tubular member 1430 in a rotated position relative to that shown in Figure 14B such that the first openings 1420, 1450 are out of alignment with one another. Second openings 1422, 1452 of the first and second plurality of openings are in alignment with one another such that inflation fluid flows from the second lumen 1436 through the second openings 1422, 1452 into the second inflatable balloon 1480. The second inflatable balloon 1480 can be inflated. Referring to Figure 14D, the inner tubular member 1430 is in a further rotated position. The inner tubular member 1430 is rotated relative to that shown in Figure 14C such that the second openings 1422, 1452 are out of alignment with one another. The first openings 1420, 1450 remain out of alignment with one another. Third openings 1424, 1454 of the first and second plurality of openings are in alignment with one another such that inflation fluid flows from the second lumen 1436 through the third openings 1424, 1454 into the third inflatable balloon 1490, inflating the third inflatable balloon 1490.

[0142] As described herein, the plurality of inflatable balloons can be sequentially deflated. Figure 14C shows the first inflatable balloon 1470 in a deflated state while the second inflatable balloon 1480 is in an inflated state. The first openings 1420, 1450 are out of alignment. Inflation fluid from the first inflatable balloon 1470 can flow through the first opening 1420 and into the gap 1460 to allow deflation of the first inflatable balloon 1470. Figure 14D shows the first inflatable balloon 1470 and second inflatable balloon 1480 in deflated states while the third inflatable balloon 1490 is in an inflated state. The second openings 1422, 1452 are out of alignment. Inflation fluid from the second inflatable balloon1480 can flow through the second opening 1422 and into the gap 1460 to allow deflation of the second inflatable balloon 1480. Sequentially rotating the pairs of openings out of alignment can provide sequential deflation of the plurality of inflatable balloons. In some instances, each of the plurality of inflatable balloons in a deflated state can have a thickness that is less than half that in an inflated state. The sequential inflation can be synchronized with the heartbeat to provide improved downstream blood flow.

[0143] In some instances, the outer and / or inner tubular members 1402, 1430 can have a length of about 20 to about 30 centimeters (cm). In some instances, a width of an outer diameter of the outer tubular member 1402 can be less than about 2 centimeters (cm), including having an outer diameter of about 1 centimeter (cm) to about 2 centimeters (cm).

[0144] Figures 15A, 15B and 15C show various views of an example of a pericardial cavity pumping system 1500 comprising a sheet member 1502 having a plurality of ferromagnetic portions 1520 coupled thereto. The sheet member 1502 can be configured to be disposed within a pericardial cavity 16 of a heart 1. An external magnet 1540 can be activated to repel and / or attract the plurality of ferromagnetic portions 1520 to facilitate movement of a wall portion of the heart 1 and thereby pumping of the heart 1. The plurality of ferromagnetic portions 1520 can be discrete portions ferromagnetic material coupled to and / or embedded within various portions of the sheet member 1502. Figure 15 A shows the sheet member 1502 disposed within the pericardial cavity 16. Figure 15B provides a plan view of the sheet member 1502 in an expanded and / or unfolded configuration. Figure 15C provides a perspective view of the sheet member 1502 in a collapsed and / or folded configuration.

[0145] In some instances, the sheet member 1502 can assume the expanded and / or unfolded configuration while the sheet member 1502 is deployed within the pericardial cavity. As described herein, Figure 15B shows the sheet member 1502 in the expanded and / or unfolded configuration. For example, the sheet member 1502 can comprise a first surface 1504 and a second opposing surface 1506. The plurality of ferromagnetic portions 1520 can be coupled to respective portions of the sheet member 1502. In some instances, the ferromagnetic portions 1520 can be distributed evenly across at least a portion of the sheet member 1502. Referring to Figure 15 A, at least a portion of the sheet member 1502 can be disposed in a portion of the pericardial cavity 16 adjacent to a left ventricle 3. For example, at least a portion of the sheet member 1502 can be adjacent to wall portions of the left ventricle 3, such that the ferromagnetic portions 1520 can be adjacent to the left ventricle. In some instances, the sheet member 1502 can be sized, such as having a width and / or length, tothereby occupy portions of the pericardial cavity 16 adjacent to the left ventricle 3. The first surface 1504 of the sheet member 1502 can be oriented toward the left ventricle 3 while the second opposing surface 1506 of the sheet member 1502 is oriented away from the left ventricle 3. An external housing 1530 can receive and / or house the external magnet 1540. In some instances, the external housing 1530 can be disposed over a portion of a chest. In some instances, a plurality of fasteners 1560 can be coupled to the housing 1530 to facilitate securing the housing 1530 to the patient. The external magnet 1540 can be configured to be activated, such as by a controller 1550 received and / or housed by the external housing 1530, to rhythmically repel and / or attract the plurality of ferromagnetic portions 1520. The external magnet 1540 can be configured to be disposed externally at a location to facilitate rhythmic repulsion and / or attraction of the plurality of ferromagnetic portions 1520. Repulsion and / or attraction of the plurality of ferromagnetic portions 1520 disposed in a pericardial cavity can be configured to cause the sheet member 1502 to push against and / or pull on heart wall portions adjacent to the left heart ventricle 3. For example, repulsion of the ferromagnetic portions 1520 by the external magnet 1540 can cause the sheet member 1502 to push against heart wall portions, such as portions of an epicardium, adjacent to the left ventricle 3 to compress the left ventricle 3. Attraction of the ferromagnetic portions 1520 by the external magnet 1540 can cause the sheet member 1502 to push against heart wall portions, such as portions of a pericardium, adjacent to the left ventricle 3 to expand the left heart ventricle 3. Activation of the external magnet 1540 can be synchronized with the heartbeat to provide pulsatile pressure applied by the sheet member 1502 during ventricular systole, thereby assisting left ventricular contraction and improving cardiac output.

[0146] Referring to Figure 15C, the sheet member 1502 can be rolled in the collapsed and / or folded configuration so as to provide a reduced footprint configuration. The rolled configuration can facilitate positioning of the sheet member 1502 into the pericardial cavity 16. In some instances, the sheet member 1502 can be inserted and / or advanced into the pericardial cavity through an incision on the pericardium. In some instances, an incision can be made through the pericardium in an apical region of the heart. For example, a sub-xiphoid approach can be used to provide rapid access, while reducing or preventing risk for emboli or thrombus formation, and without increasing afterload and blocking the blood flow path. Positioning of the sheet member 1502 can be guide by echo-guided navigation. The sheet member 1502 in the collapsed and / or folded configuration can be deployed into the pericardial cavity 16 through the incision. After insertion into the pericardial cavity 16, the sheet member 1502 can unroll. In some instances, the sheet member 1502 can comprise ashape-memory material to facilitate its unfolding and / or expansion within the pericardial cavity 16.

[0147] Figure 16A is a perspective view, and Figure 16B is a plan view, of an example of a sheet member 1600 comprising a plurality of ferromagnetic portions 1620 coupled thereto and / or embedded therein, where the sheet member 1600 is in a collapsed and / or folded configuration and an expanded / unfolded configuration, respectively. In some instances, the sheet member 1600 can be coupled to an insertion rod 1630 to facilitate advancement of the sheet member 1600 to a target position within a pericardial cavity. In some instances, the sheet member 1600 can comprise four edges, a proximal edge 1602, a distal edge 1604, and lateral edges 1606, 1608 extending between respective ends of the distal and proximal edges 1602, 1604. For example, the insertion rod 1630 can be coupled to the proximal edge 1602 of the sheet member 1600. Figure 16A shows the sheet member 1600 in a rolled configuration, such as to facilitate for insertion into the pericardial cavity. In some instances, unrolling the sheet member 1600 to allow the sheet member 1600 to assume the expanded and / or unfolded configuration can comprise, turning, such as rotating, the insertion rod 1630 around a longitudinal axis of the insertion rod 1630 and / or pivoting a distal portion the insertion rod 1630 about a proximal portion of the insertion rod 1630. For example, the sheet member 1600 can be unrolled by rotating the insertion rod 1630 around its longitudinal axis while pivoting the distal portion the insertion rod 1630 about the proximal portion of the insertion rod 1630.

[0148] In some instances, while the sheet member 1600 is in the expanded and / or unfolded configuration, the distal edge 1604 can have a length longer than that of the proximal edge 1602. In some instances, the proximal and distal edges 1602, 1604 can comprise one or more curvatures. In some instances, the one or more curvatures can have similar or the same orientation. For example, the proximal edge 1602 and the distal edge 1604 can each comprise a respective curved edge, the curved edges having the same orientation. The lateral edges 1606, 1608 can be linear or non-linear edges. In some instances, the sheet member 1600 can assume a segment of a ring shape while in the expanded and / or unfolded configuration, such as while the sheet member 1600 is disposed in a pericardial cavity. For example, an inner edge of the ring shape can be the proximal edge 1602 and an outer edge of the ring shape can be the distal edge 1604 of the sheet member 1600. A first surface 1610 of the sheet member 1600 can be oriented toward the left ventricle and a second opposing surface 1612 can be oriented away from the left ventricle, while the sheet member 1600 is deployed into the pericardial cavity.

[0149] Figure 17A is a perspective view, and Figure 17B is a plan view, of another example of a sheet member 1700 comprising a plurality of ferromagnetic portions 1720 coupled thereto and / or embedded therein. Figure 17A shows the sheet member 1700 in a collapsed and / or folded configuration and Figure 17B shows the sheet member 1700 in an expanded / unfolded configuration. In some instances, the sheet member 1700 can comprise four edges, a proximal edge 1702, a distal edge 1704, and lateral edges 1706, 1708 extending between respective ends of the distal and proximal edges 1702, 1704. The sheet member 1700, such as a proximal edge 1702 of the sheet member 1700, can be coupled to an insertion rod 1730 to facilitate advancement of the sheet member 1700 to a target position within a pericardial cavity. In some instances, while the sheet member 1700 is in the expanded and / or unfolded configuration, the distal edge 1704 can have a length longer than that of the proximal edge 1702. The sheet member 1700 can assume the expanded and / or unfolded configuration while deployed in the pericardial cavity. A first surface 1710 of the sheet member 1700 can be oriented toward the left ventricle and a second opposing surface 1712 can be oriented away from the left ventricle, while the sheet member 1700 is deployed into the pericardial cavity. In some instances, the distal edge 1704 can comprise one or more curvatures. In some instances, while in the unfolded configuration, the sheet member can have a fan shape. In some instances, the sheet member 1700 can comprise a stacked configuration while folded and / or collapsed. One or more pleats and / or folds 1714 can unfold to allow transformation of the sheet member 1700 from the collapsed and / or folded configuration to the expanded and / or unfolded configuration. In some instances, the sheet member 1700 can comprise a fan configuration. In some instances, the sheet member 1700 can comprise a shape-memory material. The sheet member 1700 can unfold and / or expand after being positioned within the pericardial cavity.Additional Description of Examples

[0150] Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.

[0151] Example 1: A medical pumping system can comprise an inflatable balloon having a first end portion configured to be disposed in an atrium of a heart or a ventricle of the heart, and a second end portion being configured to be disposed in the ventricle. The pumping system can include a tubular member defining a lumen configured to receive the inflatable balloon, the tubular member comprising a first opening on a first end portion of thetubular member being disposed in the atrium, or in the ventricle, and a second opening at a second end portion of the tubular member being disposed in the ventricle, the inflatable balloon being configured to occlude the lumen while in an inflated state to direct blood flow through the lumen from the first opening to the second opening.

[0152] Example 2: The system of any example herein, in particular example 1, wherein the inflatable balloon and tubular member can be configured to be disposed in a left ventricle of the heart, and wherein the first end portion of the tubular member can be configured to be oriented toward an apex of the heart and the second end portion of the tubular member is configured to be oriented toward an aortic valve, the first end portion of the tubular member comprising a curvature and the first opening on an opposing portion of the tubular member relative to the curvature and laterally oriented. The first end portion of the inflatable balloon can be configured to be oriented toward the apex and the second end portion of the inflatable balloon is configured to be oriented toward the aortic valve.

[0153] Example 3: The system of any example herein, in particular example 2, wherein the inflatable balloon can be configured to inflate incrementally from a deflated state to an inflated state along a longitudinal dimension of the inflatable balloon to provide incremental portions of the inflatable balloon in the inflated state, and the inflatable balloon can be configured to occlude respective portions of the lumen as the inflatable balloon is incrementally inflated.

[0154] Example 4: The system of any example herein, in particular example 3, wherein the inflatable balloon can be configured to inflate incrementally from the first end portion toward the second end portion.

[0155] Example 5: The system of any example herein, in particular example 3 or 4, wherein the inflatable balloon can be configured to deflate incrementally from the inflated state to the deflated state along the longitudinal dimension of the inflatable balloon.

[0156] Example 6: The system of any example herein, in particular example 2, further comprising a one-way valve disposed in a portion of the lumen in the first end portion of the tubular member to allow antegrade blood flow into the lumen through the first opening while preventing retrograde blood flow out of the first opening, and wherein the inflatable balloon can be configured to inflate radially to assume the inflated state.

[0157] Example 7 : The system of any example herein, in particular example 1 , wherein the first end portion of the tubular member can be configured to be disposed in an atrium of the heart, the tubular member extending through an inflow valve of the ventricle into the ventricle and the second end portion of the tubular member is configured to beoriented toward an outflow valve, the tubular member comprising a curved portion disposed in the ventricle between the first and second end portions. The inflatable balloon can be received within the tubular member, the first end portion of the inflatable balloon being disposed in the atrium and a second end portion of the inflatable balloon being disposed in the ventricle.

[0158] Example 8: The system of any example herein, in particular example 7, wherein the inflatable balloon can be configured to inflate incrementally from a deflated state to an inflated state along a longitudinal dimension of the inflatable balloon to provide incremental portions of the inflatable balloon in the inflated state, and the inflatable balloon can be configured to occlude respective portions of the lumen as the inflatable balloon is incrementally inflated.

[0159] Example 9: The system of any example herein, in particular example 8, wherein the inflatable balloon can be configured to inflate from the first end portion toward the second end portion.

[0160] Example 10: The system of any example herein, in particular example 8 or 9, wherein the inflatable balloon can be configured to deflate incrementally from the inflated state to the deflated state along the longitudinal dimension of the inflatable balloon.

[0161] Example 11 : The system of any example herein, in particular example 7, further comprising a one-way valve disposed in a portion of the lumen in the first end portion of the tubular member to allow antegrade blood flow into the lumen through the first opening while preventing retrograde blood flow out of the first opening, and wherein the inflatable balloon can be configured to inflate radially to assume the inflated state.

[0162] Example 12: The system of any example herein, in particular examples 1 to 11 , wherein, while the inflatable balloon is in the inflated state, the first end portion of the inflatable balloon can be disposed in the lumen of the first end portion of the tubular member and second end portion of the inflatable balloon can be disposed in the lumen of the second end portion of the tubular member.

[0163] Example 13: The system of any example herein, in particular examples 1 to 12, wherein the tubular member can comprise a tubular inflatable balloon having a tubular form and defining the lumen while the tubular inflatable balloon is in an inflated state.

[0164] Example 14: The system of any example herein, in particular examplel3, wherein the tubular inflatable balloon and the inflatable balloon form an integrated unit and the system can further comprise a multi-lumen inflation tube coupled to the tubular inflatable balloon and the inflatable balloon.

[0165] Example 15: The system of any example herein, in particular examples 1 to 12, wherein the tubular member can comprise a foldable member having a tubular form to define the lumen.

[0166] Example 16: A method of directing blood flow can comprise providing a tubular member comprising a first opening on a first end portion and a second opening on a second end portion, the tubular member defining a lumen extending through the tubular member between the first and second openings. The method can include providing an inflatable balloon configured to be at least partially disposed in the lumen, deploying the tubular member comprising the inflatable balloon at least partially disposed in the lumen to a heart, and inflating the inflatable balloon to provide the inflatable balloon in an inflated state and occlude the lumen of the tubular member to direct blood flow through the lumen from the first opening to the second opening.

[0167] Example 17: The method of any example herein, in particular example 16, wherein deploying the tubular member comprising the inflatable balloon at least partially disposed in the lumen to the heart can comprise positioning the tubular member and the inflatable balloon into a left ventricle.

[0168] Example 18: The method of any example herein, in particular example 17, wherein positioning the tubular member and the inflatable balloon into the left ventricle can comprise orienting the first end portion of the tubular member towards an apex of the heart, and orienting the second end portion of the tubular member towards an aortic valve, a first end portion of the inflatable balloon being oriented towards the first end portion of the tubular member and a second end portion of the inflatable balloon being oriented towards the second end portion of the tubular member.

[0169] Example 19: The method of any example herein, in particular example 16, wherein deploying the tubular member comprising the inflatable balloon at least partially disposed in the lumen to the heart can comprise positioning a first end of the tubular member in a left atrium of the heart, and positioning the second end portion of the tubular member in a left ventricle of the heart, the second opening on the second end portion being oriented toward an aortic valve, a first end portion of the inflatable balloon being oriented towards the first end portion of the tubular member and a second end portion of the inflatable balloon being oriented towards the second end portion of the tubular member.

[0170] Example 20: The method of any example herein, in particular examples 16 to 19, wherein inflating the inflatable balloon can comprise incrementally inflating theinflatable balloon from the first end portion to the second end portion of the inflatable balloon.

[0171] Example 21: The method any example herein, in particular examples 16 to 19, wherein inflating the inflatable balloon can comprise radially inflating the inflatable balloon.

[0172] Example 22: The method of any example herein, in particular example 21, wherein providing the tubular member can comprise providing a tubular member comprising a one-way valve disposed in the lumen in the first end portion of the tubular member to prevent retrograde from the lumen while the inflatable balloon is in an inflated state.

[0173] Example 23: The method of any example herein, in particular examples 16 to 22, wherein providing the tubular member can comprise providing a foldable tubular member and wherein deploying the tubular member can comprise unfolding the foldable tubular member after the foldable tubular member is disposed in a left ventricle of the heart.

[0174] Example 24: The method any example herein, in particular examples 16 to 22, wherein providing the tubular member can comprise providing a tubular inflatable balloon and wherein deploying the tubular member can comprise inflating the tubular inflatable balloon to an inflated state after the tubular inflatable balloon is disposed in a left ventricle of the heart.

[0175] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).

[0176] Example 25: A medical pumping system can comprise a fluid guide member configured to be disposed in a ventricle of a heart and comprising a first surface portion oriented toward, and a second surface portion oriented away from, a leaflet of an inflow valve of the ventricle. The pumping system can include an inflatable balloon configured to be disposed in the ventricle and against at least a portion of the second surface portion of the fluid guide member while the inflatable balloon is in an inflated state, the inflatable balloon being configured to be incrementally inflated from a deflated state to the inflated state along a longitudinal dimension of the inflatable balloon to direct blood flow away from the inflow valve.

[0177] Example 26: The system of any example herein, in particular example 25, wherein the inflatable balloon can comprise a first end configured to be oriented toward an apex of the heart and a second end configured to be oriented toward an outflow valve of theventricle, the inflatable balloon being configured to inflate incrementally from the first end toward the second end.

[0178] Example 27: The system of any example herein, in particular example 25 or 26, further comprising an engagement member extending from a first end portion of the fluid guide member to couple the fluid guide member to the leaflet, and wherein the first end portion of the fluid guide member can be configured to be oriented toward a free edge of the leaflet and a second end portion of the fluid guide member can be configured to be oriented toward an annulus of the inflow valve.

[0179] Example 28: The system of any example herein, in particular example 27, wherein the engagement member can comprise a hook extending from the first end portion of the fluid guide member, the hook comprising at least a portion that folds back over the fluid guide member to clip the fluid guide member to the leaflet.

[0180] Example 29: The system of any example herein, in particular example 28, wherein the hook can extend from a first end of the fluid guide member and the hook can comprise a portion configured to be disposed around the free edge of the leaflet and over an atrial surface portion of the leaflet to clip the fluid guide member of the leaflet.

[0181] Example 30: The system of any example herein, in particular examples 25 to 29, wherein the fluid member can comprise an expandable wire frame, the expandable wire frame comprising a first surface portion oriented toward, and a second surface portion oriented away from, the leaflet.

[0182] Example 31 : The system of any example herein, in particular example 30 further comprising a cover member over at least the second surface portion of the expandable wire frame, and wherein the inflatable balloon can be configured to be positioned against at least a portion of the cover member while in the inflated state.

[0183] Example 32: The system of any example herein, in particular example 31 , wherein a surface portion of a portion of the inflatable balloon can comprise a shape configured to conform to a shape of a corresponding portion of the cover member disposed over the second surface portion of the expandable wire frame to allow the portion of the inflatable balloon to be positioned against the cover member and prevent blood flow therebetween.

[0184] Example 33: The system of any example herein, in particular examples 30 to 32, wherein the first surface portion of the expandable wire frame can comprise a first curved surface portion to engage with a ventricularly oriented surface portion of the leaflet, the second surface portion of the expandable wire frame comprising a second curved surfaceportion, and the expandable wire frame tapering from a wider medial portion to narrower first and second end portions.

[0185] Example 34: The system of any example herein, in particular examples 30 to 33, wherein the expandable wire frame can comprise a first end portion configured to be oriented toward a free edge of the leaflet and a second end portion configured to be oriented an annulus of the inflow valve. The system can further include a hinge coupled to the second end portion of the expandable wire frame. The hinge can comprise a first portion coupled to the second end portion of the expandable wire frame, and a second portion rotatable relative to the first portion, the second portion being configured to engage with a portion of the heart between the inflow valve and an outflow valve of the ventricle to allow the expandable wire frame to move with the leaflet while the expandable wire frame is coupled to the leaflet.

[0186] Example 35: The system of any example herein, in particular examples 25 to 29, wherein the fluid guide member can comprise a sheet member.

[0187] Example 36: The system of any example herein, in particular example 35, wherein the sheet member can comprise a first end portion configured to be oriented toward a free edge of the leaflet of the inflow valve and a second end portion configured to engage with a portion of the heart between the inflow valve and an outflow valve of the ventricle.

[0188] Example 37: The system of any example herein, in particular examples 25 to 36, wherein the fluid guide member and inflatable balloon can be configured to be disposed within a left ventricle. The first surface portion of the fluid guide member can be configured to be oriented toward a ventricular surface an anterior leaflet of a mitral valve, and the inflatable balloon can comprise a first end configured to be oriented toward an apex of the heart and a second end configured to be oriented toward an aortic valve of the heart, the inflatable balloon being configured to be incrementally inflated from the first end to the second end to direct blood flow away from the mitral valve and toward the aortic valve.

[0189] Example 38: The system of any example herein, in particular examples 25 to 37, wherein the fluid guide member and the inflatable balloon can be configured to be delivered using a transcatheter delivery system, the fluid guide member being configured to be disposed distal of the inflatable balloon in a delivery catheter to allow deployment of the fluid guide member prior to deployment of the inflatable balloon.

[0190] Example 39: The system of any example herein, in particular examples 25 to 38, wherein the inflatable balloon can be configured to deflate incrementally along the longitudinal dimension of the inflatable balloon.

[0191] Example 40: A method of directing blood flow can comprise positioning a fluid guide member in a ventricle of a heart, the fluid guide member comprising a first surface portion oriented toward, and a second surface portion oriented away from, a leaflet of an inflow valve of the ventricle. The method can include positioning an inflatable balloon in the ventricle, and inflating the inflatable balloon incrementally along a longitudinal dimension of the inflatable balloon to incrementally position respective surface portions of the inflatable balloon against the second surface portion of the fluid guide member to direct blood flow away from the inflow valve to an outflow valve of the ventricle.

[0192] Example 41: The method of any example herein, in particular example 40, wherein positioning the fluid guide member in the ventricle can comprise orienting a first end portion of the fluid guide member toward a free edge of the leaflet and a second end portion of the fluid guide member toward an annulus of the inflow valve, positioning the inflatable balloon in the ventricle can comprise orienting a first end portion of the inflatable balloon toward an apex of the heart and a second end portion of the inflatable balloon toward the outflow valve, and inflating the inflatable balloon incrementally can comprise inflating the inflatable balloon incrementally from its first end portion toward its second end portion.

[0193] Example 42: The method of any example herein, in particular example 42, wherein positioning the fluid guide member in the ventricle can comprise disposing a hook coupled to a first end portion of the fluid guide member around a free edge and over an atrial surface portion of the leaflet to clip the fluid guide member to a ventricular surface of the leaflet.

[0194] Example 43: The method of any example herein, in particular examples 40 to 42, wherein positioning the fluid guide member in the ventricle can comprise positioning an expandable wire frame in the ventricle. The method can further comprise providing a hinge having a first portion coupled to an end portion of the expandable wire frame configured to be oriented an annulus of the inflow valve, and a second portion rotatable about the first portion. The method can include engaging the second portion of the hinge with a portion of the heart between the inflow valve and the outflow valve of the ventricle to allow the expandable wire frame to move with the leaflet while the expandable wire frame is coupled to the leaflet.

[0195] Example 44: The method of any example herein, in particular examples 40 to 43, wherein positioning the fluid guide member in a ventricle and positioning the inflatable balloon in the ventricle can comprise advancing a delivery catheter carrying the fluid guide member and the inflatable balloon into a left ventricle through an aorta, orientingthe first surface portion of the fluid guide toward a ventricular surface an anterior leaflet of a mitral valve, and orienting a first end portion of the inflatable balloon towards an apex of the heart and a second end portion towards an aortic valve, the inflatable balloon being configured to be incrementally inflated from the first end portion to the second end portion to direct blood flow away from the mitral valve and toward the aortic valve.

[0196] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).

[0197] Example 45: A medical pumping system can comprise a guidewire comprising a first portion configured to be disposed through an inflow valve of a heart ventricle and a second portion disposed through an outflow valve of the heart ventricle, and a medial portion within the heart ventricle between the first and second portions that forms a curvature having a convex portion oriented toward a heart apex. The pumping system can include an inflatable balloon configured to be disposed in the heart ventricle along the guidewire on an inflow valve side of the curvature, around the curvature, and on an outflow valve side of the curvature, the inflatable balloon being configured to be inflatable incrementally to an inflated state from portions disposed on the inflow valve side, to portions disposed around the curvature, and then to portions disposed on the outflow valve side, of the guidewire, to direct blood flow through the heart ventricle from the inflow valve to the outflow valve.

[0198] Example 46: The system of any example herein, in particular example 45, wherein the inflatable balloon can be configured to be disposed in a left heart ventricle, and the inflatable balloon can be configured to inflate incrementally from a deflated state to the inflated state to occupy left ventricular space from a mitral valve to an aortic valve to direct blood flow through the heart ventricle from the mitral valve to the aortic valve.

[0199] Example 47: The system of any example herein, in particular example 45 or 46, wherein the inflated state of the inflatable balloon can comprise a cross-section having a triangular shape.

[0200] Example 48: The system of any example herein, in particular example 47, wherein while the inflatable balloon is in the inflated state the triangular shape can comprise a first comer portion oriented toward the inflow valve, a second comer portion oriented toward the heart apex, and a third corner portion oriented toward the heart outflow valve, the inflatable balloon inflatable incrementally from the first comer portion, to the second comer portion, and then to the third comer portion.

[0201] Example 49: The system of any example herein, in particular examples 45 to 48, wherein the inflatable balloon can be configured to deflate incrementally from the portions disposed on the inflow valve side, to portions around the curvature, and then to portions disposed on the outflow valve side, of the guidewire.

[0202] Example 50: A cardiac piston pump system can comprise a tubular frame comprising a first tubular branch defining a first lumen and sized to be at least partially disposed in a brachiocephalic artery, and a second tubular branch defining a second lumen in fluid communication with the first lumen and coupled to the first tubular branch at an angle, the second tubular branch being sized to be at least partially disposed in an ascending aorta. The system can include a junction portion of the tubular frame that comprises a proximal end portion of the second tubular branch and a distal end portion of the first tubular branch. A piston can be disposed within the first lumen, the piston being translatable away from the second tubular branch to pull blood into the second lumen, and translatable toward the second tubular branch to push blood out of the second lumen and into an aortic arch.

[0203] Example 51: The system of any example herein, in particular example 50, further comprising a first one-way valve disposed within the second lumen, the one-way valve assuming an open state to allow antegrade blood flow into the second lumen through a distal end opening of the second tubular branch and reduce retrograde blood into the left heart ventricle from the second lumen through the distal end opening.

[0204] Example 52: The system of any example herein, in particular example 50 or 51 , wherein the tubular frame can form an “L” shape.

[0205] Example 53: The system of any example herein, in particular example 52, wherein the junction portion can comprise an opening to provide fluid communication between the first and second lumens, and the aortic arch.

[0206] Example 54: The system of any example herein, in particular example 53, further comprising a second one-way valve disposed in the junction portion to allow antegrade blood flow from the tubular frame into the aortic arch through the opening and reduce retrograde blood flow from the aortic arch through the opening into the tubular frame.

[0207] Example 55: The system of any example herein, in particular example 50, wherein the tubular frame further comprises a third tubular branch having a proximal end portion coupled to the distal end portion of the first arm and the proximal end portion of the second arm to provide a tubular frame having a branched configuration, the joint portion comprising the distal end portion of the first arm, and proximal end portions of the second and third tubular branches.

[0208] Example 56: The system of any example herein, in particular examples 50 to 55, wherein the second tubular branch can be sized to provide a distal end portion of the second tubular branch disposed within the ascending aorta.

[0209] Example 57: The system of any example herein, in particular examples 50 to 55, wherein the second tubular branch can be sized to provide a distal end portion of the second tubular branch disposed through an aortic valve and a distal end of the second tubular branch disposed in a left ventricle.

[0210] Example 58: The system of any example herein, in particular examples 50 to 57, wherein the piston comprises a third one-way valve configured to assume a closed state as the piston is translated away from the second tubular branch and an open state as the piston is translated toward the second tubular branch.

[0211] Example 59: The system of any example herein, in particular examples 50 to 58, wherein the first and second tubular branches each can comprise outer diameters configured to allow wall portions of the first and second tubular branches to be spaced from respective wall portions of the brachiocephalic artery and ascending aorta.[ 02121 Example 60: A cardiac piston pump system can comprise a frame comprising at least a portion having a tubular shape defining a first lumen and sized to be disposed within an aorta, a foldable membrane having a proximal end portion circumferentially coupled to a distal end portion of the frame and sized to be disposed in the aorta, and a one-way valve coupled to a distal end portion of the foldable membrane, the foldable membrane being configured to fold and move the one-way valve toward the frame and to unfold and move the one-way valve away from the frame. The one-way valve can be configured to assume an open state as the one-way valve is moved away from the frame to allow blood flow into the first lumen, and the one-way valve can be configured to assume a closed state as the one-way valve is moved toward the frame to pump blood proximally through the first lumen.

[0213] Example 61: The system of any example herein, in particular example 60, wherein the one-way valve can be configured to be at least partially disposed in the first lumen with the foldable membrane in a folded configuration and the one-way valve in a most proximal position.

[0214] Example 62: The system of any example herein, in particular example 60 or 61, wherein the foldable membrane can assume a cylindrical shape in an unfolded configuration.

[0215] Example 63: The system of any example herein, in particular example 62, wherein the one-way valve can comprise a duckbill valve.

[0216] Example 64: The system of any example herein, in particular example 60 or 61 , wherein the foldable membrane can comprise a truncated conical configuration, the distal portion of the foldable membrane having a lateral dimension smaller than that of the proximal portion of the foldable membrane.

[0217] Example 65: The system of any example herein, in particular example 64, wherein the one-way valve can comprise a mesh cone, a larger end portion of the mesh cone being coupled to the distal end portion of the foldable membrane, and the system further comprising a covering over surface portions of the mesh cone oriented towards the first lumen.

[0218] Example 66: The system of any example herein, in particular example 65, wherein a smaller end portion of the mesh cone can be distally oriented while the foldable membrane is in an unfolded configuration and the smaller end portion of the mesh cone can be proximally oriented while the foldable membrane is folded to move the one-way valve toward the frame.

[0219] Example 67: The system of any example herein, in particular examples 60 to 66, wherein the frame can comprise an expandable frame comprising at least a portion configured to assume a cylindrical shape in a deployed state.

[0220] Example 68: The system of any example herein, in particular examples 60 to 67, further comprising a drive shaft extending through the first lumen and coupled to the one-way valve to move the one-way valve away from and toward the frame.

[0221] Example 69: The system of any example herein, in particular example 68, further comprising a plurality of support struts coupling a distal end portion of the drive shaft and the one-way valve.

[0222] Example 70: The system of any example herein, in particular example 68 or 69, further comprising an atraumatic nosecone coupled to a distal end of the drive shaft.

[0223] Example 71: The system of any example herein, in particular examples 60 to 70, further comprising a sealing membrane disposed at least partially circumferentially around the frame to provide surface portions for engagement with respective wall portions of the aorta.

[0224] Example 72: A cardiac peristaltic pump system can comprise an outer tubular member defining a first lumen and comprising a first plurality of openings extending through respective wall portions of the outer tubular member, and an inner tubular memberdefining a second lumen and configured to be disposed within the first lumen, the inner tubular member comprising a second plurality of openings extending through respective wall portions of the second tubular member and configured to be rotatable relative to the outer tubular member to sequentially align respective ones of the first and second plurality of openings. The system can include a plurality of inflatable balloons each disposed at a respective circumferential position around a longitudinal dimension of the outer tubular member and each inflatable balloon aligned with a respective one of the first plurality of openings, sequential alignment of respective ones of the first and second plurality of openings allowing inflation fluid from the second lumen to sequentially inflate the plurality of balloons from a distal most inflatable balloon to a proximal most inflatable balloon.

[0225] Example 73: The system of any example herein, in particular example 72, wherein an outer lateral dimension of the inner tubular member can be smaller than a lateral dimension of the first lumen to provide a gap between the inner and outer tubular members, the gap being configured to allow passage of inflation fluid from an inflatable balloon into the first lumen as respective ones of the plurality of first and second plurality of openings rotate out of alignment with one another to provide sequential deflation of the plurality of inflatable balloons.

[0226] Example 74: The system of any example herein, in particular example 72 or 73, wherein each of the first plurality of openings can be at a respective position along a line extending along a longitudinal dimension of the outer tubular member.

[0227] Example 75: The system of any example herein, in particular examples 72 to 74, wherein each of the second plurality of openings can be at a respective position along at least a partial spiral around the inner tubular member.

[0228] Example 76: The system of any example herein, in particular examples 72 to 75, wherein each of the plurality of inflatable balloons can be sized to occlude a respective portion of a descending aorta in an inflated state, sequential inflation of the plurality of inflatable balloons being configured to push blood through the descending aorta away from a left ventricle.

[0229] Example 77: The system of any example herein, in particular examples 72 to 76, wherein each of the plurality of inflatable balloons in a deflated state can be sized to have a thickness that is less than half that in an inflated state.

[0230] Example 78: A pericardial cavity pump can comprise a sheet member sized to be disposed in at least a portion of a pericardial cavity of a heart, and a plurality of ferromagnetic portions coupled to respective portions of the sheet member. The system caninclude an external housing comprising an external magnet housed therein, the external magnet being configured to be activated to rhythmically repel the plurality of ferromagnetic portions and cause the sheet member to push against an adjacent heart wall portion and compress an adjacent heart ventricle.

[0231] Example 79: The system of any example herein, in particular example 78, wherein the sheet member can be configured to assume a folded configuration for insertion of the sheet member into the pericardial cavity and to assume an unfolded configuration in the pericardial cavity.

[0232] Example 80: The system of any example herein, in particular example 79, wherein the sheet member in the folded configuration can comprise a rolled configuration.

[0233] Example 81 : The system of any example herein, in particular example 79, wherein the sheet member in the folded configuration can comprise a stacked configuration.

[0234] Example 82: The system of any example herein, in particular examples 79 to 81 , wherein the sheet member in the unfolded configuration can comprise a distal edge having a length longer than that of a proximal edge.|0235| Example 83: The system of any example herein, in particular example 82, wherein the sheet member in the unfolded configuration can assume a segment of a ring shape.

[0236] Example 84: The of system of any example herein, in particular examples 78 to 83, wherein the external magnet can further be configured to be activated to rhythmically attract the plurality of ferromagnetic portions and cause the sheet member to push against an adjacent pericardium portion to expand the adjacent heart ventricle.

[0237] Example 85: The system of any example herein, in particular examples 78 to 84, wherein a proximal portion of the sheet member can be coupled to an insertion rod.

[0238] Example 86: The system of any example herein, in particular examples 78 to 85, further comprising fasteners coupled to the external housing to position the external housing on a chest area over the heart.

[0239] Depending on the example, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain examples, not all described acts or events are necessary for the practice of the processes.

[0240] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generallyintended to convey that certain examples include, while other examples do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular example. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.102411 It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single example, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and / or described in a particular example herein can be applied to or used with any other example(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each example. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular examples described above, but should be determined only by a fair reading of the claims that follow.

[0242] It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed“based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

[0243] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example examples belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0244] The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.

[0245] Unless otherwise expressly stated, comparative and / or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”

Claims

WHAT IS CLAIMED IS:

1. An implantable pumping system for improving blood circulation through a heart, comprising: an inflatable balloon sized to have a first end portion disposed in an atrium of a heart or a ventricle of the heart, and a second end portion disposed in the ventricle; and a tubular member defining a lumen adapted to receive the inflatable balloon, the tubular member sized to have: a first opening on a first end portion of the tubular member disposed in the atrium, or in the ventricle, and a second opening at a second end portion of the tubular member disposed in the ventricle, the inflatable balloon being adapted to occlude the lumen while in an inflated state to direct blood flow through the lumen from the first opening to the second opening.

2. The system of claim 1 , wherein the inflatable balloon is adapted to inflate incrementally from a deflated state to an inflated state along a longitudinal dimension of the inflatable balloon to provide incremental portions of the inflatable balloon in the inflated state, and the inflatable balloon occluding incremental portions of the lumen as the inflatable balloon is incrementally inflated.

3. The system of claim 1 or 2, wherein the inflatable balloon is adapted to inflate incrementally from the first end portion toward the second end portion.

4. The system of claim 1 or 2, wherein the inflatable balloon is adapted to deflate incrementally from the inflated state to the deflated state along a longitudinal dimension of the inflatable balloon.

5. The system of claim 1 or 2, further comprising a one-way valve disposed in a portion of the lumen in the first end portion of the tubular member to allow antegrade blood flow into the lumen through the first opening while preventing retrograde blood flow out of the first opening, and wherein the inflatable balloon is adapted to inflate radially to assume the inflated state.

6. The system of claim 1 or 2, wherein the inflatable balloon and tubular member are sized to be disposed in a left ventricle of the heart, and wherein: the first end portion of the tubular member is adapted to be oriented toward an apex of the heart and the second end portion of the tubular member is adapted to be oriented toward an aortic valve, the first end portion of the tubular member comprising a curvature and the first opening being on an opposing portion of the tubular member relative to the curvature and laterally oriented; and the first and second end portions of the inflatable balloon having a common orientation as that of the first and second end portions of the tubular member.

7. The system of claim 1 or 2, wherein: the tubular member is sized to have the first end portion of the tubular member disposed in an atrium of the heart, the tubular member being adapted to extend through an inflow valve of the ventricle into the ventricle, and the second end portion of the tubular member is adapted to be oriented toward an outflow valve, the tubular member comprising a curved portion adapted to be disposed in the ventricle between the first and second end portions; and the inflatable balloon is received within the tubular member, the first end portion of the inflatable balloon being adapted to be disposed in the first end portion of the tubular member and a second end portion of the inflatable balloon being adapted to be disposed in the second end portion of the tubular member.

8. The system of claim 1 or 2, wherein, while the inflatable balloon is in the inflated state, the first end portion of the inflatable balloon is disposed in the lumen of the first end portion of the tubular member and second end portion of the inflatable balloon is disposed in the lumen of the second end portion of the tubular member.

9. The system of claim 1 or 2, wherein the tubular member comprises a tubular inflatable balloon having a tubular form and defining the lumen while the tubular inflatable balloon is in an inflated state.

10. The system of claim 9, wherein the tubular inflatable balloon and the inflatable balloon form an integrated unit and the system further comprises a multi-lumen inflation tube coupled to the tubular inflatable balloon and the inflatable balloon.

11. The system of claim 1 or 2, wherein the tubular member comprises a foldable member having a tubular form to define the lumen.

12. A medical pumping system comprising: a tubular member adapted to be at least partially disposed in a ventricle of a heart, the tubular member defining a first opening, a second opening, and a lumen extending between the first opening and the second opening; and an inflatable balloon disposed in the lumen, the inflatable balloon being directionally inflatable within the lumen to direct blood flow through the lumen from the first opening toward the second opening.

13. The system of claim 12, wherein the inflatable balloon is inflatable along a longitudinal dimension.

14. The system of claim 12 or 13, wherein the inflatable balloon is radially inflatable along a lateral dimension.

15. The system of claim 12 or 13, wherein the tubular member is adapted to be disposed in the ventricle, and wherein: the first opening is on a first end portion of the tubular member adapted to be oriented toward an apical region of the heart; and the second opening is on a second end portion of the tubular member adapted to be oriented toward an outflow valve of the ventricle.

16. The system of claim 15, wherein the first end portion of the tubular member comprises a convexly curved exterior surface portion adapted to be oriented toward a ventricular wall portion and the first opening is on an opposing portion of the tubular member relative to the curved surface portion.

17. The system of claim 16, wherein the first opening and second opening comprise orientations that are angled relative to one another.

18. The system of claim 15, wherein the inflatable balloon assumes an elongate shape comprising a convexly curved surface portion on a first end portion adapted to be oriented toward an inner surface portion of the tubular member having the convexly curved exterior surface portion.

19. The system of claim 12 or 13, wherein the tubular member is adapted to assume a “U’- shape.

20. The system of claim 19, wherein the first opening is on a first end of the tubular member adapted to be disposed in an atrium; and the second opening is on a second end of the tubular member adapted to be disposed in the ventricle and oriented toward an outflow valve of the ventricle.

21. The system of claim 12 or 13, wherein the tubular member comprises an inflatable tubular member.

22. The system of claim 12 or 13, wherein the tubular member comprises a foldable member having a tubular form.

23. The system of claim 12 or 13, wherein the inflatable balloon directionally inflates to occlude incremental portions of the lumen to direct the blood flow through the lumen from the first opening to the second opening.

24. The system of claim 23, wherein the inflatable balloon is adapted to assume a fully inflated state to occlude the lumen from the first opening to the second opening.

25. The system of claim 12 or 13, wherein the inflatable balloon directionally inflates to sequentially occlude corresponding portions of the lumen to direct the blood flow through the lumen from the first opening to the second opening.

26. The system of claim 12 or 13, wherein the inflatable balloon directionally deflates from the first opening toward the second opening.

27. An implantable pump for improving blood circulation through a heart, the implantable pump comprising: a tubular member having a first opening and a second opening; and an elongate balloon disposed within a lumen of the tubular member; wherein the balloon is adapted to inflate into contact with an inner wall of the tubular member and wherein the balloon is adapted to progressively inflate along a longitudinal axis for pushing blood through the lumen of the tubular member, thereby improving blood circulation through the heart.

28. The implantable pump of claim 27, wherein the second opening is located downstream of the first opening.

29. The implantable pump of claim 27, wherein the elongate balloon inflates from the first opening toward the second opening for pumping blood through the heart in an antegrade direction.

30. The implantable pump of claim 27, wherein the first opening is sized for placement in a ventricle.

31. The implantable pump of claim 27, wherein the first opening is sized for placement in an atrium.

32. The implantable pump of claim 31 , wherein the tubular member has a curved configuration and wherein the tubular member is shaped to extend from a left atrium toward an aortic valve for enhancing circulation through the left side of the heart.

33. The implantable pump of claim 27, wherein a one-way valve is provided in the lumen of the tubular member for ensuring antegrade flow through the tubular member.

34. The implantable pump of claim 27, wherein the elongate balloon is inflated with a liquid.

35. The implantable pump of claim 34, wherein the elongate balloon is inflated with saline.

36. The implantable pump of claim 27, wherein the elongate balloon is inflated with a gas.

37. The implantable pump of claim 27, wherein the tubular member and elongate balloon are collapsible for delivery into the heart via a delivery catheter.

38. The implantable pump of claim 27, wherein the tubular member comprises a collapsible frame and a cover over at least a portion of the collapsible frame.

39. The implantable pump of claim 38, wherein the collapsible frame is made from a shape memory material.

40. An assembly comprising:a guidewire comprising a portion adapted to be disposed within a ventricle of a heart through an outflow valve of the ventricle; an inflatable balloon adapted to be disposed along at least a portion of the guidewire disposed in the ventricle; and a tubular member defining a lumen, the inflatable balloon adapted to be disposed in the lumen, and the inflatable balloon being adapted to inflate along the portion of the guidewire to direct blood flow through the lumen of the tubular member and augment blood flow through the ventricle to the outflow valve.

41. The assembly of claim 40, wherein the inflatable balloon is adapted to incrementally inflate along a direction from a first end portion of the inflatable balloon oriented away from the outflow valve toward a second end portion of the inflatable balloon oriented toward the outflow valve to direct the blood flow through the lumen of the tubular member.

42. The assembly of claim 40, wherein the inflatable balloon is adapted to sequentially inflate along a direction from a first end portion of the inflatable balloon oriented away from the outflow valve toward a second end portion of the inflatable balloon oriented toward the outflow valve to direct the blood flow through the lumen of the tubular member.

43. The assembly of any one of claims 40 to 42, wherein the inflatable balloon is adapted to radially inflate along a lateral dimension to direct the blood flow through the lumen of the tubular member.

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