Pulmonary vein retrograde blood flow management

Abstract

A medical implant device includes an anchor sized to be positioned within a pulmonary vein, and a flow-reducing member having a first end portion and a second end portion, the second end portion being coupled to the anchor. At least the second end portion of the flow-reducing member is shaped to be positioned within the pulmonary vein in a region between a left atrium and the anchor. The flow-reducing member may include a convex portion between the first and second end portions, the convex portion being oriented to engage with wall portions of the pulmonary vein.

Description

PULMONARY VEIN RETROGRADE BLOOD FLOW MANAGEMENTCROSS REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 604,786, filed November 30, 2023, the disclosure of which is hereby expressly incorporated by reference herein in its entirety for all purposes.BACKGROUND

[0002] The present disclosure generally relates to the field of medical implant devices. An unhealthy heart may not be able to efficiently pump blood. Inefficient pumping can result in increased pressure in the left atrium and retrograde blood flow from the left atrium into the pulmonary veins. Retrograde blood flow into the pulmonary veins can result in fluid being pushed into the lungs, leading to lung congestion and eventual right-sided heart failure.SUMMARY

[0003] Described herein are methods, devices and / or systems relating to reducing or preventing retrograde blood flow into and / or through one or more pulmonary veins from the left atrium. In some instances, flow-reducing devices described herein can reduce or prevent retrograde blood flow from a left atrium into and / or through the pulmonary vein, while permitting forward flow of blood from the pulmonary vein into the left atrium. In some instances, the flow-reducing devices can comprise a one-way valve configured to allow forward blood flow through the pulmonary vein into the left atrium and prevent or substantially prevent retrograde blood flow from the left atrium into and / or through the pulmonary vein. The devices and / or methods described can prevent or reduce a back-up of pulmonary pressures and consequent lung congestion, and heart failure.

[0004] 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, for example, an entire body, a portion of abody 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 silica, 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.

[0005] 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

[0006] 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.100071 Figure 1 shows certain anatomical features of human vasculature, including various features of a human heart.

[0008] Figures 2A and 2B show a flow-reducing device deployed into a pulmonary vein during atrial systole and diastole, respectively, in accordance with one or more examples.

[0009] Figure 3 provides a perspective view of a flow-reducing device comprising a flow-reducing member with a deformable concave portion, in accordance with one or more examples.

[0010] Figure 4 provides a perspective view of a flow-reducing device comprising a flow-reducing member with a deformable concave portion, in accordance with one or more examples.

[0011] Figures 5 A and 5B show the flow-reducing device described with reference to Figure 3 deployed in a pulmonary vein during atrial systole and atrial diastole, respectively, in accordance with one or more examples.

[0012] Figure 6 provides a perspective view of a flow-reducing device comprising a flow-reducing member having a deformable funnel portion, in accordance with one or more examples.

[0013] Figures 7 A and 7B show the flow-reducing device described with reference to Figure 6 deployed to a pulmonary vein during atrial systole and atrial diastole, respectively, in accordance with one or more examples.100141 Figure 8 provides a perspective view of an example of a flowreducing device comprising an anchor that includes a radially expandable frame, in accordance with one or more examples.

[0015] Figure 9 shows the flow-reducing device described with reference to Figure 8 deployed to a pulmonary vein during atrial systole and atrial diastole, respectively, in accordance with one or more examples.

[0016] Figures 10A and 10B show a flow-reducing device deployed to a left atrium during atrial systole and atrial diastole, respectively, in accordance with one or more examples.

[0017] Figures HA and 11B show a flow-reducing device comprising an inflatable flow-reducing member deployed to a left atrium and pulmonary veins during atrial systole and atrial diastole, respectively, in accordance with one or more examples.

[0018] Figures 12A and 12B show side views of a flow-reducing device comprising an occlusion member positioned within a left atrium during atrial systole and atrial diastole, respectively, in accordance with one or more examples.

[0019] Figure 12C shows a top-down view of the flow-reducing device of Figures 12A and 12B in the left atrium, in accordance with one or more examples.

[0020] Figure 13 shows a top-down view of a flow-reducing device in the left atrium, in accordance with one or more examples.

[0021] Figures 14 shows shunt devices coupled to adjacent pulmonary veins to provide blood flow between adjacent pulmonary veins, in accordance with one or more examples.

[0022] Figures 15 shows shunt devices coupled to adjacent pulmonary veins to provide blood flow between adjacent pulmonary veins, in accordance with one or more examples.

[0023] Figure 16 is a process flow diagram showing an example of a method of implanting a shunt device.

[0024] Figure 17 provides a cut-away view of an example of a flowreducing device comprising a piezoelectric material composition, in accordance with one or more examples.

[0025] Figure 18 shows the flow-reducing device described with reference to Figure 17 deployed into a left atrium, in accordance with one or more examples.|0026| Figure 19 provides a perspective view of a flow-reducing device comprising a tubular reflector member, in accordance with one or more examples.

[0027] Figure 20 shows a flow-reducing device deployed into each of four pulmonary veins, in accordance with one or more examples.

[0028] Figure 21 provides a process flow diagram of an example of a process for deploying a flow-reducing device.

[0029] Figure 22 provides a side cross-sectional view of a flow-reducing device, in accordance with one or more examples.

[0030] Figure 23 shows the flow-reducing device described with reference to Figure 22 deployed to a left atrial appendage, in accordance with one or more examples.DETAILED DESCRIPTION100311 The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0032] 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 here from is not limited by any of the particular examplesdescribed 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.

[0033] 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.

[0034] Figure 1 shows certain anatomical features of human vasculature, including various features of a human heart 1. The heart 1 includes four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. A wall of muscle, referred to as the septal wall 10, 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 9. The mitral valve 6 separates the left atrium2 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 12. The tricuspid valve 8 separates the right atrium 5 and the right ventricle 4 and controls blood flow therebetween. The pulmonary valve 9 separates the right ventricle 4 and the pulmonary trunk or artery 11, controlling blood flow therebetween.

[0035] 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 superior and inferior venae cavae 19, 16 and coronary sinus 13 can flow into the right atrium 5. Oxygen-rich blood from the lungs can flow through the four pulmonary veins 20, 21, 22, 23 into the left atrium 2. 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 11 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 12 for transport to the rest of the body.

[0036] An unhealthy heart can fail to efficiently pump blood. For example, inefficient pumping by the heart can result in increased pressure in the left atrium 2. Retrograde blood flow from the left atrium 2 into the pulmonary veins 20, 21, 22, 23 can undesirably occur. For example, retrograde blood flow into the pulmonary veins 20, 21, 22, 23 can occur with high left-sided filling pressures and / or a distended left atrium 2. Retrograde blood flow into the pulmonary veins 20, 21, 22, 23 can result in fluid being pushed into the lungs, resulting in lung congestion and eventual rightsided heart failure. Normal oxygen movement through the lungs can be reduced. Patients can often experience shortness of breath.

[0037] Described herein are devices, systems and methods relating to reducing or preventing retrograde blood flow into and / or through one or more pulmonary veins from the left atrium. Flow-reducing devices described herein can be deployed to the heart and / or one or more pulmonary veins to reduce or prevent retrograde flow of deoxygenated blood from the left atrium into and / or through thepulmonary veins, while permitting forward flow of oxygen-rich blood from the pulmonary veins into the left atrium. The flow-reducing devices can be configured to be at least partially disposed within a pulmonary vein and / or left atrium, including at least partially within a left atrial appendage of the left atrium, and / or coupled to a pair of pulmonary veins, to provide the desired retrograde flow reduction or elimination. In some instances, a flow-reducing device can serve as a one-way valve configured to allow forward blood flow through a pulmonary vein into the left atrium while preventing or substantially preventing retrograde blood flow from the left atrium into and / or through the pulmonary vein. The devices and / or methods described can prevent or reduce a back-up of pulmonary pressures and consequent lung congestion, and heart failure, such as right-sided heart failure.

[0038] Flow-reducing devices described herein can be delivered using minimally invasive transcatheter delivery procedures. In some instances, delivery of one or more devices can comprise insertion into a femoral vein for advancement to a target site. In alternative instances, the devices can be inserted into any number of other vessels and / or lumens. In some instances, a trans-septal approach can be used to position a flow-reducing device into a left atrium and / or pulmonary vein. For example, a device can be advanced into a femoral vein through an access opening, and from the femoral vein into an inferior vena cava. The device can be advanced from the inferior vena cava into the right atrium, and from the right atrium into the left atrium through the atrial septum.

[0039] It will be understood that one or more components of the flowreducing devices can undergo various processes in preparation for their use in the procedures, including for example sterilization processes. The flow-reducing devices can be sterilized flow-reducing devices.

[0040] 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.

[0041] Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulatedpatient, 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, for example, 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 silica, 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.

[0042] Figures 2A and 2B show a cut-away view of a portion of a heart 1 and a flow-reducing device 200 deployed into the heart 1. The cut-away view of the heart 1 shows a portion of a left atrium 2, and a first pulmonary vein 20 and a second pulmonary vein 21 that feed oxygen-rich blood into the left atrium 2. The flowreducing device 200 can be deployed so as to be positioned within the first pulmonary vein 20. The flow-reducing device 200 can comprise a flow-reducing member 202 and an anchor 270. The flow-reducing member 202 and the anchor 270 can be configured to be disposed within the first pulmonary vein 20. The flow-reducing member 202 can be configured to be oriented toward the left atrium 2. The anchor 270 can be oriented away from the left atrium 2. For example, the flow-reducing member 202 can be positioned between the anchor 270 and the left atrium 2. The flow-reducing member 202 can comprise a first end portion 204 configured to be oriented toward the left atrium 2. In some instances, the flow-reducing member 202 can be entirely or substantially entirely within the pulmonary vein 20. A second end portion 206 of the flow-reducing member 202 can be configured to be oriented away from the left atrium 2, including being opposingly oriented relative to the first end portion 204. A first end portion 272 of the anchor can be configured to be oriented toward and coupled to the flow-reducing member 202, such as the second end portion 206 of the flow-reducing member 202. A second end portion 274 of the anchor 270 can be configured to be oriented away from the flow-reducing member 202. In some instances, a portion of the flow-reducing member 202, such as at least a portion of the first end portion 204, can be positioned at or proximate to an ostium 24 of the firstpulmonary vein 20. In some instances, wall portions defining the ostium 24 can close against and / or open and move away from the flow-reducing member 202 during atrial systole and diastole, respectively. In some instances, the flow-reducing member 202 can occlude or substantially occlude a portion of the pulmonary vein 20 and / or the ostium 24. Although only one flow-reducing device 200 is shown as being deployed into the heart 1, it will be understood that one or more other pulmonary veins can comprise a respective flow-reducing device 200 deployed thereto. For example, a flow-reducing device 200 can be deployed to each of the pulmonary veins.

[0043] In some instances, the flow-reducing member 202 can comprise round and / or curved surface portions 210, including convexly curved surface portions, configured to engage with respective inner wall portions of the first pulmonary vein 20 while the left atrium 2 is in atrial systole. For example, the round and / or curved surface portions 210 can be configured to be oriented toward the respective inner wall portions of the first pulmonary vein 20. In some instances, the first and / or second end portions 204, 206 can comprise the round and / or curved surface portions 210. In some instances, medial portions extending between the first and second end portions 204, 206, such as laterally and outwardly oriented surface portions, can comprise the round and / or curved surface portions 210. As described in further detail herein, the round and / or curved surface portions 210 can be configured to be in contact with inner wall portions of the first pulmonary vein 20 and / or wall portions defining the ostium 24 during atrial systole to reduce or prevent retrograde blood flow past the flow-reducing device 200.

[0044] In some instances, the flow-reducing member 202 can have a ball configuration. In some instances, the flow-reducing member 202 can comprise a ball, including a spherical or oval-shaped ball. For example, the flow-reducing member 202 can be a ball, including a spherical and / or oval-shaped ball. In some instances, the first end portion 272 of the anchor 270 can be oriented toward and coupled to the ball. The second end portion 274 of the anchor 270 can be oriented away from the ball. In some instances, the ball can be oval-shaped. First and second end portions 204, 206 of the flow-reducing member 202 can be narrower portions of the oval-shaped ball, such that the anchor 270 can be coupled to a narrower end portion of the oval-shaped ball.

[0045] In some instances, the flow-reducing member 202 can comprise a compressible and / or inflatable member. For example, the flow-reducing member 202 can comprise a compressible and / or inflatable ball. In some instances, thecompressible and / or inflatable ball can be inflated at or proximate to a target delivery site, such as a target position within the first pulmonary vein 20. In some instances, flow-reducing member 202 can comprise an inflatable balloon, including a spherical inflatable ball or oval-shaped inflatable ball. In some instances, the inflatable balloon can be inflated to an expanded state, including a state in which the inflatable balloon is deployed in the pulmonary vein, at or proximate to the target delivery site. The inflatable balloon can be advanced to or proximate to the target delivery site in a collapsed state, such as a state having a lateral dimension, including a diameter, smaller than that of the expanded state. Alternatively, in some instances, the flowreducing member 202 can comprise an incompressible member. For example, the flow-reducing member 202 can comprise an incompressible ball, such as an incompressible spherical ball or incompressible oval ball. In some instances, the flowreducing member 202 can comprise polystyrene, including a polystyrene ball.

[0046] In some instances, the anchor 270 can comprise a coil spring 280. A first end portion 282 of the coil spring 280 can be configured to be coupled to the flow-reducing member 202. A second end portion 284 can be configured to be oriented away from the flow-reducing member 202. One or more portions of the coil spring 280 can engage with inner wall portions of the first pulmonary vein 20. In some instances, the coil spring 280 can be expanded and / or compressed to transition between relaxed and stressed states so as to maintain engagement with the inner wall portions during both atrial systole and diastole for anchoring the flow-reducing member 202. In some instances, the second end portion 284 can be configured to engage with respective inner wall portions of the first pulmonary vein 20, such as to secure the position of the flow-reducing device 200. In some instances, the coil spring 280 can comprise a conical coil spring. A smaller end portion of the conical coil spring can be configured to be coupled to the flow -reducing member 202. A larger end portion of the conical coil spring being configured to engage with the respective inner wall portions of the first pulmonary vein. In some instances, a diameter of the coil spring 280, including a diameter of the larger end portion of the conical coil spring, while in the relaxed state, can be about 0.5 centimeters (cm) to about 3 centimeters (cm), including about 1 centimeter (cm) to about 2 centimeters (cm). In some instances, the coil spring 280 can expand to an expanded state, such as a deployed state, from a compressed state after the flow-reducing device 200 is positioned at or proximate to the target delivery site to facilitate delivery of the flow-reducing device 200. Alternatively, or in combination, the anchor 270 can comprise a plurality of curved rods and / or a plurality of curved barbs (e.g., having one more features of the plurality of curved rods 372 described with reference to Figures 3, 5A and 5B). For example, a first end portion of the curved rods and / or curved barbs can be coupled to the flow -reducing member 202 and a second end portion of the cured rods and / or curved barbs can be configured to engage with inner wall portions of a pulmonary vein.

[0047] Referring to Figure 2A, the flow-reducing member 202 can occlude or substantially occlude the first pulmonary vein 20 and / or ostium 24 during at least a portion of atrial systole. The flow-reducing member 202 can prevent or substantially prevent retrograde blood flow from the left atrium 2 past the flow-reducing member 202 in the first pulmonary vein 20. The round and / or curved surface portions 210 can engage with and form a seal with respective inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24 such that no or substantially no blood flow passes the flow-reducing member 202. In some instances, cardiac muscle contraction during atrial systole can cause inner wall portions of the first pulmonary vein 20 to narrow and cinch down and / or tighten around portions of the flow-reducing member 202, such as the round and / or curved surface portions 210, including the first end portion 204 and / or the laterally and outwardly oriented portions. Narrowing of the first pulmonary vein 20 can facilitate occlusion thereof by the flow-reducing member 202. In some instances, the ostium 24 can narrow to facilitate occlusion thereof by the flow-reducing member 202.

[0048] Referring to Figure 2B, during at least a portion of atrial diastole, the round and / or curved surface portions 210 can be spaced from inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24. Space between the round surface portions 210 of the flow-reducing member 202 and the respective inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24 can allow forward blood flow past the flow-reducing member 202. The flow-reducing member 202 can be sized and / or shaped to allow sufficient blood flow during atrial diastole. For example, the flow-reducing member 202 can be sized, such as a width and / or diameter, including a widest diameter, to occlude less than about 80% of a lateral cross-sectional area of the first pulmonary vein 20 during atrial diastole, including occluding between about 60% and about 80% of the lateral cross-sectional area. A size of the flow-reducing device 200, includingthe flow-reducing member 202, can be selected to provide positioning at the target site, while providing desired reduction or prevention of retrograde blood flow through the pulmonary vein 20 and allowing desired antegrade blood flow. In some instances, a widest lateral dimension, such as a widest diameter, of the flow -reducing member 202 while deployed at the target site can be sized to reduce or prevent, including occlude or substantially occlude, the pulmonary vein 20 and / or ostium 24 during atrial systole while allowing sufficient antegrade blood flow during atrial diastole. For example, a size (e.g.. a widest diameter) and / or shape of the flow-reducing member 202 can remain constant or substantially constant, such as during both atrial systole and atrial diastole. In some instances, a widest lateral dimension, such as a widest diameter, of the flow-reducing member 202 can be about 0.5 centimeters (cm) to about 3 centimeters (cm), including about 1 centimeter (cm) to about 2 centimeters (cm).

[0049] In some alternative instances, a flow-reducing member can be configured to reduce retrograde blood flow into and / or through the first pulmonary vein 20 during atrial systole, without occluding the first pulmonary vein 20. The flowreducing member can allow a first retrograde blood flow rate past the flow-reducing member 202 during atrial systole and a second forward blood flow rate past the flowreducing member 202 during atrial diastole. The first retrograde flow rate can be less than the second forward flow rate. For example, a space between round and / or curved surface portions of the flow-reducing member and inner surface portions of the pulmonary vein wall during atrial systole can be less than that during atrial diastole.

[0050] Figures 3 and 4 provide perspective views of examples of flowreducing devices 300, 400 each comprising a flow-reducing member 302, 402 having a deformable concave portion 310, 410. The flow-reducing member 302, 402 can comprise a first end portion 304, 404 configured to be oriented toward a left atrium, and a second end portion 306, 406 configured to be oriented away from the left atrium and coupled to an anchor 370, 470. The deformable concave portion 310, 410 can each comprise a first end portion 312, 412 and a second end portion 314, 414. The deformable concave portion 310, 410 can comprise a concave curvature 320, 420 configured to be oriented away from the anchor 370, 470. For example, the first end portion 312, 412, including a first end 316, 416, of the deformable concave portion 310, 410 can have a lateral cross section larger than that of the second end portion 314, 414, including a second end 318, 418, of the deformable concave portion 310,410. The anchor 370, 470 can be coupled to the second end portion 314, 414 of the deformable concave portion 310, 410.

[0051] In some instances, a first surface portion 324, 424 of the deformable concave portion 10, 410 can define and / or form at least a portion of the concave curvature 320, 420. A second surface portion 326, 426, such as a second opposing surface portion, can define and / or form at least a portion of a convex curvature 322, 422 of the deformable concave portion 310, 410. The convex curvature 322, 422 can be configured to be oriented toward the anchor 370, 470. In some instances, the deformable concave portion 310, 410 can assume a paraboloid configuration. For example, a concave portion of the paraboloid being configured to be oriented away from the anchor 370, 470. A convex portion of the paraboloid being configured to be oriented toward the anchor 370, 470.

[0052] In some instances, the deformable concave portion 310, 410 can comprise a deformable material 328, 428. The deformable material 328, 428 can be foldable and / or stretchable, including a fabric material. For example, the deformable material 328, 428 can form at least a portion of the deformable concave portion 310, 410. A first surface portion 330, 430 of the deformable material 328, 428 can define and / or form at least a portion of the concave curvature 320, 420. For example, the first surface portion 330, 430 can define and / or form the concave curvature 320, 420. A second surface portion 332, 432 of the deformable material 328, 428 can define and / or form at least a portion of the convex curvature 322, 422 of the deformable concave portion 310, 410. For example, the second surface portion 332, 432 can define and / or form the convex curvature 322, 422. In some instances, the deformable material 328, 428 can form and / or define the deformable concave portion 310, 410. For example, an edge 334, 434 of the deformable material 328, 428 can be the first end 316, 416 of the deformable concave portion 310, 410. In some instances, a center portion 336, 436 of the deformable material 328, 428 can define and / or form the second end portion 314 of the deformable concave portion 310.

[0053] A plurality of elongate reinforcement rods 340, 440 can be coupled to the deformable material 328, 428. In some instances, the plurality of elongate reinforcement rods 340, 440 can be flexible, bendable and / or deformable. In some instances, the plurality of elongate reinforcement rods 340, 440 can be arranged in a radial pattern. The plurality of elongate reinforcement rods 340, 440 can provide radial mechanical reinforcement for the deformable concave portion 310, 410. Forexample, the plurality of elongate reinforcement rods 340, 440 can extend radially from the second end portion 314, 414 of the deformable concave portion 310, 410. The plurality of elongate reinforcement rods 340, 440 can be coupled to the first surface portion 330, 430, the second surface portion 332, 432 and / or be embedded at least partially within the deformable material 328, 428. In some instances, the plurality of elongate reinforcement rods 340, 440 can be coupled to and extend radially from the center portion 336, 436 of the deformable material 328, 428, including to the edge 334, 434 of the deformable material 328, 428. For example, a first end 342, 442 of each of the plurality of elongate can be at the edge 334, 434 of the deformable material 328, 428. In some instances, a second end 344, 444 of each of the plurality of elongate reinforcement rods 340, 440 can be at the center portion 336, 436, including a center 338, 438, of the deformable material 328, 428. In some instances, the plurality of elongate reinforcement rods 340, 440 can be evenly distributed in a radial pattern. In some instances, the deformable concave portion 310, 410 can assume an umbrella canopy configuration. Although Figures 3 and 4 show the flow-reducing devices 300, 400 each comprising four elongate reinforcement rods 340, 440, it will be understood that more or fewer elongate reinforcement rods 340, 440 can be applicable.

[0054] In some instances, the deformable material 328, 428 can have a single and / or unitary sheet configuration. Alternatively, the deformable material 328, 428 can comprise a plurality of individual panel portions. For example, individual panel portions, including individual panel portions having a triangular shape, can be coupled to respective adjacent elongate reinforcement rods 340, 440. For example, the deformable concave portion 310, 410 can comprise four individual panel portions of the deformable material 328, 428. Respective edges of each individual panel portion can be coupled to a respective adjacent elongate reinforcement rod 340, 440 to form the deformable concave portion 310, 410.

[0055] As described in further detail herein, at least a portion of the flowreducing devices 300, 400 can be positioned within a pulmonary vein. For example, a portion of the flow-reducing member 302, 402 can be disposed within the pulmonary vein. The concave curvature 320, 420 of the deformable concave portion 310, 410 can be oriented toward the left atrium. The deformable concave portion 310, 410 can assume an open and / or expanded state during atrial systole to prevent or reduce retrograde blood flow past the flow-reducing member 302, 402 and into thepulmonary vein. Retrograde blood flow toward the deformable concave portion 310, 410 can push against the first surface portion 324, 424 of the deformable concave portion 310, 410 and cause the deformable concave portion 310, 410 to assume the open and / or expanded state. The second surface portion 326, 426 can engage with wall portions defining the ostium of the pulmonary vein while the deformable concave portion 310, 410 is open and / or expanded so as to occlude or substantially occlude the ostium. A size of the flow-reducing device 300, 400, including the flowreducing member 302, 402 can be selected to allow desired positioning at the target location, while providing the reduction or prevention of retrograde blood flow and allowing desired antegrade blood flow through the pulmonary vein. In some instances, a widest lateral dimension, such as a widest diameter, of the deformable concave portion 310, 410 while in the open and / or expanded state can be sized to occlude or substantially occlude, the ostium and / or pulmonary vein during atrial systole. In some instances, the widest lateral dimension, such as the widest diameter, of the deformable concave portion 310, 410 while in the open and / or expanded state can be about 0.5 centimeters (cm) to about 3 centimeters (cm), including about 1 centimeter (cm) to about 2 centimeters (cm). The deformable concave portion 310, 410 can assume a closed and / or collapsed state during atrial diastole such that blood flow through the pulmonary vein, past the flow-reducing member 302, 402 and into the left atrium is allowed. Forward blood flow through the pulmonary vein and toward the left atrium can exert force upon the second surface portion 326, 426 of the deformable concave portion 310, 410 to cause the deformable concave portion 310, 410 to assume the closed and / or collapsed state. As described in further detail herein, the flow-reducing member 302, 402 can be configured to occlude less than about 80% of a lateral cross-sectional area of a pulmonary vein and / or ostium during atrial diastole, including about 60% to about 80%, while in the closed and / or collapsed state. For example, the deformable concave portion 310, 410 in the closed and / or collapsed state can have a widest diameter to provide a lateral cross-sectional area that is less than about 80% of the lateral cross-sectional area of the pulmonary vein and / or ostium during atrial diastole, including about 60% to about 80%.

[0056] Referring to Figure 3, an anchor 370 comprising a plurality of curved rods 372 can be coupled to the flow-reducing member 302. In some instances, the anchor 370 can be the plurality of curved rods 372. In some instances, the plurality of curved rods 372 can comprise a plurality of curved barbs. A first end 374of each of the plurality of curved rods 372 can be coupled to the deformable concave portion 310. The first end 374 can be coupled to the second end portion 314, including the second end 318, of the deformable concave portion 310. In some instances, each of the plurality of curved rods 372 can extend along a concave curvature from the first end 374 to a second end 376 such that the second end 376 is further laterally disposed relative to the first end 374. As described in further detail herein, the second end 376 of each of the plurality of curved rods 372 can be configured to engage with inner wall portions of a pulmonary vein.

[0057] Referring to Figure 4, an anchor 470 comprising a coil spring 472 is shown being coupled to the flow-reducing member 402. In some instances, the anchor 470 can be the coil spring 472. A first end 474 of the coil spring 472 can be coupled to the deformable concave portion 410. The first end 474 can be coupled to the second end portion 414, including the second end 418, of the deformable concave portion 410. As described in further detail herein, a second end 476 of the coil spring 472 can be configured to engage with inner wall portions of a pulmonary vein. In some instances, the coil spring 472 can comprise a conical coil spring, for example the first end 474 having a smaller lateral cross-sectional size than that of the second end 476. The coil spring 472, including the conical coil spring, can have one or more features of the coil spring 280 described with reference to Figures 2 A and 2B.

[0058] In some instances, the flow-reducing device 300, 400 can comprise an intermediate connector 380, 480 for coupling the anchor 370, 470 to the flowreducing member 302, 402. For example, the first end 374, 474 of the anchor 370, 470 can be coupled to, such as directly to, the intermediate connector 380, 480. The intermediate connector 380, 480 can be coupled to, such as directly to, the flowreducing member 302, 402. The intermediate connector 380, 480 can provide mechanical reinforcement for securely positioning the devices 300, 400 in the pulmonary vein. Alternatively, the anchor 370, 470 can be coupled directly to the flow-reducing member 302, 402. For example, the anchor 370, 470 can be coupled directly to the second end portion 314, 414 of the deformable concave portion 310, 410.

[0059] Figures 5A and 5B provide cut-away views of a left atrium 2 and a first pulmonary vein 20 and a second pulmonary vein 21 of a heart 1 and the flowreducing device 300 described with reference to Figure 3 deployed to the first pulmonary vein 20. In some instances, the flow-reducing device 400 described withreference to Figure 4 can be deployed to a pulmonary vein in the same or similar manner as described for the flow-reducing device 300. Figure 5A shows the flowreducing device 300 during atrial systole and Figure 5B shows the flow-reducing device 300 during atrial diastole. The deformable concave portion 310 can be configured to be oriented toward the left atrium 2. For example, the concave curvature 320 can be oriented toward the left atrium 2 and the convex curvature 322 can be oriented away from the left atrium 2. Although only one flow-reducing device 300 is shown as being deployed into the heart 1 , it will be understood that one or more other pulmonary veins can comprise a respective flow-reducing device 300 deployed thereto. For example, a flow-reducing device 300 can be deployed to each of the pulmonary veins.

[0060] At least a portion of the flow-reducing device 300 can be positioned within the first pulmonary vein 20. In some instances, the first end portion 304 of the flow-reducing member 302 can be disposed in the left atrium 2. The second end portion 306 of the flow-reducing member 302 can be disposed in the first pulmonary vein 20. For example, a portion of the deformable concave portion 310 can be disposed within the left atrium 2. The first end portion 312, including the first end 316, of the deformable concave portion 310 can be configured to be disposed within the left atrium 2. Remainder portions of the deformable concave portion 310, including the second end portion 314, and the anchor 370 can be disposed within the first pulmonary vein 20. Alternatively, the first end 316 can be at or proximate to the ostium 24 such that the flow-reducing member 302 is disposed entirely or substantially entirely within the pulmonary vein 20. The second ends 376 of the curved rods 372 can engage with respective inner wall portions of the first pulmonary vein 20.

[0061] Referring to Figure 5 A, the deformable concave portion 310 can assume an open and / or expanded state during at least a portion of atrial systole to prevent or reduce retrograde blood flow past the flow-reducing member 302 and into the first pulmonary vein 20. The deformable concave portion 310 can assume an open and / or expanded state such that the deformable concave portion 310 occludes or substantially occludes the ostium 24 of the first pulmonary vein 20. Outwardly and / or laterally oriented portions of the deformable concave portion 310 having the convex curvature 322 can engage with inner wall portions defining the first pulmonary vein 20 and / or ostium 24. In some instances, retrograde blood flow toward the deformableconcave portion 310 can push against the deformable concave portion 310, such as the portion of the deformable concave portion 310 comprising the concave curvature 320, to thereby cause the deformable concave portion 310 to assume the open and / or expanded state. For example, force exerted by retrograde blood flow can push against the first surface portion 324 of the deformable concave portion 310 and cause the deformable concave portion 310 to assume the open and / or expanded state. Respective portions of the second surface portion 326, including outwardly and / or laterally oriented portions of the deformable concave portion 310 having the convex curvature 322, can engage respective inner wall portions defining the ostium 24 and / or inner wall portions of the first pulmonary vein 20 to prevent or reduce retrograde blood flow into the first pulmonary vein 20.

[0062] Referring to Figure 5B, the deformable concave portion 310 can assume a closed and / or collapsed state during at least a portion of atrial diastole to allow forward blood flow through the first pulmonary vein 20, past the flow-reducing member 302 and into the left atrium 2. Forward blood flow through the first pulmonary vein 20 can exert force upon the second surface portion 326 of the deformable concave portion 310 to cause the deformable concave portion 310 to assume a closed and / or collapsed state. In the closed and / or collapsed state, the flowreducing member 302 can occlude less than about 80% of a lateral cross-sectional area of the first pulmonary vein 20 and / or ostium 24, including about 60% to about 80%. For example, the deformable concave portion 310 in the closed and / or collapsed state can occlude less than about 80% of a lateral cross-sectional area of the first pulmonary vein 20 and / or ostium 24, including occluding about 60% to about 80% of the lateral cross-sectional area, such that sufficient forward blood flow is permitted therethrough.

[0063] As described in herein, the deformable concave portion 310, 410 can assume an umbrella canopy configuration. A concave portion of the umbrella canopy can be oriented toward the left atrium 2. A first end portion of the umbrella canopy can be configured to be positioned within the left atrium 2 and a second end portion of the umbrella canopy can be configured to be positioned within the first pulmonary vein 20 and coupled to the anchor 370, 470.

[0064] Figure 6 provides a perspective view of a flow-reducing device 600 comprising a flow-reducing member 602 having a deformable funnel portion 610. The flow-reducing device 600 can comprise an anchor 670 coupled to the flow-reducingmember 602. As described in further detail herein, the flow-reducing device 600 can be configured to be deployed within a pulmonary vein. For example, a first end portion 604 of the flow-reducing member 602 can be configured to be oriented toward a left atrium. A second end portion 606 of the flow-reducing member 602 can be configured to be oriented away from the left atrium. The second end portion 606 can be coupled to the anchor 670. For example, a first end portion 612 of the deformable funnel portion 610 can be configured to be oriented toward the left atrium and a second end portion 614 can be configured to be oriented away from the left atrium.

[0065] Referring to Figure 6, the first end portion 612 of the deformable funnel portion 610 can have a lateral cross-sectional size larger than that of a second end portion 614. A first end opening 620 can be at a first end 616 and a second end opening 622 can be at a second end 618 of the deformable funnel portion 610, the first end opening 620 having a lateral cross-sectional size larger than that of the second end opening 622. The deformable funnel portion 610 can comprise a central lumen 624 extending through the deformable funnel portion 610 and along a longitudinal axis of the deformable funnel portion 610, providing fluid communication between the first and second end openings 620, 622. In some instances, at least a portion of the first end portion 612, including the first end 616, can be configured to engage with respective inner wall portions of the pulmonary vein and / or inner wall portions defining the ostium of the pulmonary vein. For example, the first end 616 can engage with respective inner wall portions of the pulmonary vein and / or inner wall portions defining the ostium of the pulmonary vein to facilitate securely positioning the flowreducing device 600 in the pulmonary vein. A size of the flow-reducing device 600, including the flow-reducing member 602, can be selected to allow desired positioning of the flow-reducing device 600 at the target site, while providing the reduction of retrograde blood flow and allowing the desired antegrade blood flow through the pulmonary vein.

[0066] The deformable funnel portion 610 can be radially expandable along at least a portion thereof. In some instances, the deformable funnel portion 610 can expand and contract along a radial dimension along an entire or substantially entire longitudinal dimension, such as a length, thereof, to provide the deformable funnel portion 610 in an expanded or collapsed state, respectively. The longitudinal dimension can be parallel or substantially parallel to a longitudinal axis of the deformable funnel portion 610, for example extending between the first and secondend portions 612, 614. For example, a lateral dimension, such as a diameter, of the deformable funnel portion 610 can reversibly increase and decrease along an entire or substantially entire length of the deformable funnel portion 610, thereby radially expanding and / or collapsing along the entire or substantially entire length. The lateral dimension can be perpendicular or substantially perpendicular to the longitudinal dimension. In some instances, the deformable funnel portion 610 can comprise a deformable material 626. The deformable material 626 can be foldable and / or stretchable to facilitate the increase and decrease in the lateral dimension of the deformable funnel portion 610. In some instances, the deformable material 626 can comprise a fabric material. For example, the deformable material 626 can form at least a portion of a side wall 636 of the deformable funnel portion 610. In some instances, the deformable material 626 can extend circumferentially to form the side wall 636 of the deformable funnel portion 610. In some instances, the central lumen 624 can be defined at least in part by the deformable material 626. For example, a first surface portion 628, such as an inner surface portion, of the deformable material 626 can be an inner surface 638 of the side wall 636 defining the central lumen 624. A second surface portion 630, such as an outer surface portion, of the deformable material 626 can be an outer surface 640 of the side wall 636. In some instances, a first end 632 of the deformable material 626 can define at least in part the first end 616 of the deformable funnel portion 610, for example defining the first end opening 620. A second end 634 of the deformable material 626 can define at least in part the second end 618 of the deformable funnel portion 610, for example defining the second end opening 622. A diameter of respective portions of the deformable funnel portion 610, including that of the central lumen 624, can increase or decrease as the deformable material 626 stretches and / or unfolds or relaxes and / or folds, respectively. For example, Figure 6 shows the deformable funnel portion 610 in an expanded state. The deformable material 626 can be in an unfolded and / or stretched state while the deformable funnel portion 610 is in the expanded state. As described in further detail herein, the deformable material 626 can be in a folded and / or un-stretched state while the deformable funnel portion 610 is in the collapsed state.

[0067] A plurality of elongate reinforcement rods 650 can be coupled to the deformable material 626 to provide mechanical strength along a longitudinal dimension of the deformable funnel portion 610. Although Figure 6 shows six elongate reinforcement rods 650, it will be understood that more or fewer elongatereinforcement rods 650 can be used (e.g., three, four, five, or eight). In some instances, the plurality of elongate reinforcement rods 650 can be circumferentially disposed. The plurality of elongate reinforcement rods 650 can be coupled to the first surface portion 628, the second surface portion 630 and / or be embedded at least partially within the deformable material 626. The plurality of elongate reinforcement rods 650 can be coupled to the deformable material 626 at respective positions around a circumference of the deformable funnel portion 610. For example, the plurality of elongate reinforcement rods 650 can be evenly distributed around the circumference. In some instances, the plurality of elongate reinforcement rods 650 can extend along an entire or substantially entire length of the deformable material 626, including an entire or substantially entire length of the deformable funnel portion 610. For example, ends 652, 654 of each of the plurality of elongate reinforcement rods 650 can be at the first and second end 616, 618 of the deformable funnel portion 610 respectively. In some instances, the plurality of elongate reinforcement rods 650 can be flexible, bendable and / or deformable.100681 In some instances, the deformable material 626 can have a single and / or unitary sheet configuration. Alternatively, the deformable material 626 can comprise a plurality of individual panel portions, opposing portions of each individual panel portion being coupled to respective adjacent elongate reinforcement rods 650.

[0069] In some instances, the deformable funnel portion 610 can comprise a concave curvature 660 along at least a portion of its longitudinal dimension, such as the length. For example, at least a portion of the second surface portion 630, such as the outer surface portion, of the deformable material 626 and / or the outer surface 640 of the side wall 636 can extend along the concave curvature 660. The concave curvature 660 can be configured to be oriented toward the inner wall of the pulmonary vein. In some instances, the concave curvature 660 can extend along a portion of the deformable funnel portion 610, including along the first end portion 612, such as to facilitate engagement of the first end 616 with inner wall portions of the pulmonary vein and / or wall portions defining the ostium. In some instances, a portion of each of the plurality of elongate reinforcement rods 650 can comprise a concave curvature 656. For example, the concave curvature 656 of the plurality of elongate reinforcement rods 650 can form and / or provide reinforcement for the concave curvature 660 of the deformable funnel portion 610.

[0070] In some instances, the anchor 670 can comprise a plurality of curved barbs 672. For example, a first end portion 674 of each of the plurality of curved barbs 672 can be configured to be coupled to the deformable funnel portion 610, such as the second end portion 614 of the deformable funnel portion 610. A second end portion 676 of each of the plurality of curved barbs 672 can be configured to engage with wall portions of the pulmonary vein. In some instances, the plurality of curved barbs 672 can extend toward the first end portion 612 of the deformable funnel portion 610. The plurality of curved barbs 672 can curve outwardly and extend from the second end portion 614 toward the first end portion 612. For example, each of the plurality of curved barbs 672 can comprise a concave curvature oriented toward the second end portion 614 of the deformable funnel portion 610. In alternative instances, or in combination, an anchor can comprise a coil spring, including a conical coil spring (e.g., having one or more features of the coil spring 280 described with reference to Figures 2 A and 2B), and a plurality of curved rods (e.g., having one or more features of the curved rods 372 described with reference to Figures 3, and 5A and 5B). For example, the conical coil spring and / or curved rods can be coupled to the second end portion 614 of the deformable funnel portion 610. In some instances, the anchors 670 can expand to a deployed state from a compressed state at or proximate to a target delivery site. For example, the anchors 670 can transform to the deployed state and engage with inner wall portions of the pulmonary vein.

[0071] Figures 7A and 7B provide cut-away views of a left atrium 2 and a first pulmonary vein 20 and a second pulmonary vein 21 of a heart 1, and the flowreducing device 600 described with reference to Figure 6 deployed to the first pulmonary vein 20. In some instances, a respective flow-reducing device 600 can be deployed to one or more other pulmonary veins. Figure 7 A shows the flow-reducing device 600 during atrial systole and Figure 7B shows the flow-reducing device 600 during atrial diastole. The flow-reducing device 600 can be positioned within or substantially within the first pulmonary vein 20. For example, the first end 616 of the deformable funnel portion 610 can be within the first pulmonary vein 20 and oriented toward the left atrium 2. At least a portion of the first end portion 612, such as the first end 616, of the deformable funnel portion 610 can engage with wall portions of the first pulmonary vein 20 and / or the ostium 24. In some instances, the first ends 652 of each of the plurality of elongate reinforcement rods 650 can engage with respective wall portions of the first pulmonary vein 20 and / or inner wall portions definingostium 24. The anchor 670 can be engaged with respective wall portions of the first pulmonary vein 20 at further upstream positions relative to that engaged by the first end 616.

[0072] Figure 7A shows the flow-reducing device 600 in an expanded state. For example, the deformable funnel portion 610 is shown in an expanded state. Referring to Figure 7A, retrograde blood flow during atrial systole is shown as passing from the left atrium 2 into the first pulmonary vein 20 and through the central lumen 624. The first end 616 of the deformable funnel portion 610 can prevent or substantially prevent blood flow around the flow-reducing device 600, such as around the deformable funnel portion 610. For example, no or substantially no retrograde blood flows between the first end 616 of the deformable funnel portion 610 and respective inner wall portions of the first pulmonary vein 20. The funnel shape of the deformable funnel portion 610 can reduce retrograde blood flow through the first pulmonary vein 20. Force exerted upon the deformable funnel portion 610, such as the deformable material 626, can cause the deformable funnel portion 610 to form a seal between the deformable funnel portion 610 and inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24 to prevent blood flow around the deformable funnel portion 610. For example, force exerted upon the first surface portion 628 of the deformable material 626 by the retrograde blood flow can cause the deformable material 626 to assume the expanded configuration, facilitating engagement between the deformable material 626, such as the first end 632 of the deformable material 626, and inner wall portions of the first pulmonary vein 20 and / or the ostium 24. While in the expanded state, the deformable material 626 can be stretched and / or unfolded. In some instances, an outer diameter of the first end 632 of the deformable material 626, while in the expanded state, can be about 0.5 centimeters (cm) to about 3 centimeters (cm), including about 1 centimeter (cm) to about 2 centimeters (cm). Alternatively, a retrograde blood flow can pass between the first end 616 of the deformable funnel portion 610 and respective inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24 during atrial systole. The retrograde blood flow passing between the first end 616 of the deformable funnel portion 610 and respective inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24 during atrial systole can be less than that occurring during atrial diastole. For example, one or more gaps remain between the deformable funnel portion 610 and respective inner wallportions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24.

[0073] Referring to Figure 7B, forward blood flow is shown as passing through the central lumen 624 and around the flow-reducing device 600. For example, forward blood flows between the first end 616 of the deformable funnel portion 610 and respective inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24. Force exerted upon the deformable funnel portion 610, such as the deformable material 626, by forward blood flow can cause the deformable funnel portion 610 to collapse and provide space between the deformable funnel portion 610 and the inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24. Figure 7B shows the flow-reducing device 600 in the collapsed state. For example, the deformable funnel portion 610 is shown in the collapsed state. For example, force exerted upon the second surface portion 630 of the deformable material 626 by the forward blood flow can cause the deformable material 626 to assume a collapsed configuration, providing spaces between the deformable material 626 and inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24. Sufficient blood flow can be provided through the central lumen 624 and spaces between the deformable material 626 and inner wall portions of the first pulmonary vein 20 and / or inner wall portions defining the ostium 24. While in the collapsed state, the deformable material 626 can be unstretched and / or folded. In some instances, the deformable funnel 610 portion can be configured to occlude less than about 80% of a lateral cross-sectional area of a pulmonary vein and / or ostium during atrial diastole, including about 60% to about 80%, while in the closed and / or collapsed state. In some instances, the deformable material 626 in the un-stretched and / or folded state can have a widest diameter to provide a lateral cross-sectional area that is less than about 80% of the lateral cross- sectional area of the pulmonary vein and / or ostium during atrial diastole, including about 60% to about 80%.

[0074] Figure 8 provides a perspective view of an example of a flowreducing device 800 comprising an anchor 850 that includes a radially expandable frame 852. For example, the radially expandable frame 852 can have a tubular configuration. For example, at least a portion of the radially expandable frame 852 can assume a cylindrical shape. The radially expandable frame 852 can expand along a lateral dimension, such as diameter. The lateral dimension can be perpendicular orsubstantially perpendicular to a longitudinal axis of the radially expandable frame 852. The radially expandable frame 852 can be positioned to or proximate to a target site in a collapsed state, and subsequently radially expand to an expanded state for deployment at the target site. The radially expandable frame 852 can comprise a first end portion 854 configured to be oriented toward a left atrium and a second end portion 856 configured to be oriented away from the left atrium. In some instances, the longitudinal axis of the radially expandable frame 852 can extend between the first and second end portions 854, 856. The radially expandable frame 852 can comprise a central lumen 880 extending therethrough, for example providing fluid communication between a first end opening 862 at a first end 858 and a second end opening 864 at a second end 860. In some instances, the first and second ends 858, 860 can be opposingly oriented. A first surface portion 866, such as an inner surface portion, of the frame 852 can define the central lumen 880. A second surface portion 868, such as an outer surface portion, of the frame 852 can be configured to engage with inner wall portions of the pulmonary vein. In some instances, the radially expandable frame 852 can comprise an expandable stent. The radially expandable frame 852 can be sized to facilitate engagement with inner wall portions of the pulmonary vein. In some instances, while the expandable frame 852 is in the expanded state, portions of the radially expandable frame 852 configured to engage with the pulmonary vein, such as cylindrical portions, can have an outer diameter of about 0.5 centimeters (cm) to about 3 centimeters (cm), including about 1 centimeter (cm) to about 2 centimeters (cm).

[0075] The flow-reducing device 800 can have a flow-reducing member 802 comprising a cover member 804 coupled to the anchor 850. The cover member 804 can be rotatably coupled to the radially expandable frame 852. For example, the flow-reducing device 800 can comprise a hinge 820 configured to rotatably couple the cover member 804 to the radially expandable frame 852. While the flow-reducing device 800 is in a closed state, the cover member 804 can seal and / or occlude or substantially occlude the central lumen 880. For example, the cover member 804 can be configured to be oriented perpendicularly or substantially perpendicularly relative to the longitudinal axis of the radially expandable frame 852. The central lumen 880 can extend along and / or parallel or substantially parallel to the longitudinal axis of the radially expandable frame 852. While the flow-reducing device 800 is in a closed state, the cover member 804 can seal and / or occlude or substantially occlude the firstend opening 862. In some instances, the cover member 804 can comprise a first surface portion 806 configured to be oriented away from the central lumen 880 and a second surface portion 808 configured to be oriented toward the central lumen 880, while flow-reducing device 800 is in the closed state. While the flow-reducing device 800 is in an open state, the cover member 804 can allow blood flow through the central lumen 880. For example, the cover member 804 can be configured to be oriented obliquely, or be parallel or substantially parallel, to the longitudinal axis of the radially expandable frame 852.

[0076] In some instances, the first end portion 854 can comprise a tapered portion 870 that tapers inwardly to provide a first end 858 that has a lateral dimension smaller than that of portions closer to the second end portion 856. The tapered portion 870 can comprise a tapered profile that tapers along a convex curvature inwardly toward the longitudinal axis of the radially expandable frame 852 along a direction extending from the second end 860 toward the first end 858 of the radially expandable frame 852. For example, the expandable frame 852 can comprise a convexly curved tapered portion that tapers from a cylindrical portion to the first end 858. In some instances, a lateral dimension, such as diameter, of the first end opening 862 can be smaller than that of one or more portions of the central lumen 880, such as that of a portion of the central lumen 880 at a position closer to the second end portion 856 of the radially expandable frame 852. In some instances, the cover member 804 can be configured to be rotatably coupled to the first end portion 854, including the tapered portion 870. For example, the cover member 804 can be disposed within a portion of the central lumen 880 in the first end portion 854, thereby occluding the central lumen 880 in the first end portion 854 while the radially expandable frame 852 is in the closed state. In some instances, the cover member 804 can be rotatably coupled to the first end 858 of the radially expandable frame 852, for example occluding the first end opening 862 while the radially expandable frame 852 is in the closed state. In some instances, while in the closed state, the cover member 804 can be disposed over the first end 858 of the radially expandable frame 852 and occlude or substantially occlude the first end opening 862.

[0077] In some instances, the cover member 804 can comprise a leaflet. The hinge 820 can rotatably couple the leaflet to the radially expandable frame 852 to allow the leaflet to occlude the central lumen 880 during atrial systole and to allow blood flow through the central lumen 880 during atrial diastole.

[0078] In some instances, a cover member can comprise a plurality of leaflets. For example, each of the plurality of leaflets can be rotatably coupled to an anchor, such as a radially expandable frame. A respective hinge can rotatably couple each leaflet to the radially expandable frame.

[0079] Figure 9 provides a cut-away view of a left atrium 2 and a first pulmonary vein 20 and a second pulmonary vein 21 of a heart 1, and the flowreducing device 800 described with reference to Figure 8 deployed to the first pulmonary vein 20. The flow-reducing device 800 can be at least partially disposed within the first pulmonary vein 20. The first end portion 854 of the radially expandable frame 852 can be oriented toward the left atrium 2. The second end portion 856 of the radially expandable frame 852 can be oriented away from the left atrium 2. In some instances, the first end 858 of the radially expandable frame 852 can be disposed at the ostium 24 of the first pulmonary vein 20 or within the first pulmonary vein 20. In some instances, the first end portion 854, including the first end 858, can be disposed in the left atrium 2. At least a portion of the second surface portion 868, such as an outer surface portion, of the frame 852 can be configured to engage with inner wall portions of the first pulmonary vein 20 to facilitate anchoring the flow-reducing device 800. In some instances, a respective flow-reducing device 800 can be deployed to one or more other pulmonary veins.

[0080] During atrial systole, the flow-reducing device 800 can assume a closed state. Force exerted by retrograde blood flow on the first surface portion 806 of the cover member 804 can cause the cover member 804 to be perpendicularly or substantially perpendicularly oriented relative to the longitudinal axis of the radially expandable frame 852. For example, the cover member 804 can then seal and / or occlude or substantially occclude the first end opening 862. The flow-reducing device 800 can thereby prevent or reduce retrograde blood flow from the left atrium 2 into the first pulmonary vein.

[0081] During atrial diastole, forward blood flow push against the second surface portion 808 of the cover member 804, thereby causing the cover member 804 to be obliquely oriented or be parallel or substantially parallel to the longitudinal axis of the radially expandable frame 852. Forward blood flow can push against the cover member 804 and cause the cover member 804 to pivot about the hinge 820 and rotate away from the radially expandable frame 852. For example, while the flow-reducing device 800 is in the open state, forward blood flow can pass through the second endopening 864, the central lumen 880 and then the first end opening 862, and past the cover member 804.

[0082] Figures 10A and 10B provide cut-away views of a left atrium 2 of a heart 1 and ostia 24, 25, 26, 27 of four pulmonary veins that open into the left atrium 2, and a flow-reducing device 1000 deployed to the left atrium 2. Figure 10A shows the flow-reducing device 1000 in the left atrium 2 during atrial systole and Figure 10B shows the flow-reducing device 1000 in the left atrium 2 during atrial diastole. The flow-reducing device 1000 can comprise an inflatable flow-reducing member 1002. At least a portion of the inflatable flow-reducing member 1002 can be configured to be disposed within the left atrium 2. For example, the inflatable flowreducing member 1002 can be entirely within the left atrium 2. The inflatable flowreducing member 1002 can comprise an occluding portion 1004 configured to be positioned against an inner surface portion of the left atrial wall and / or one or more of the pulmonary vein ostia to prevent or reduce retrograde blood flow into the respective pulmonary vein. In some instances, the inflatable flow-reducing member 1002 can comprise a wall portion 1010 having an inner surface 1012 at least partially defining an inner chamber 1020. An outer surface 1014 of the wall portion 1010 can be configured to be oriented toward respective portions of the left atrial wall. The outer surface 1014 can comprise one or more round and / or curved portions configured to engage with the left atrial wall and / or one or more of the pulmonary vein ostia. In some instances, the occluding portion 1004 can comprise one or more portions of the wall portion 1010. For example, the occluding portion 1004 can comprise one or more of the round and / or curved outer surface portions 1014.

[0083] In some instances, the inflatable flow-reducing member 1002 can assume a spherical configuration. In some instances, the inflatable flow-reducing member 1002 can assume another ellipsoid configuration. In some instances, the inflatable flow- reducing member 1002 can have a partial ellipsoid configuration, including a partially spherical shape, such as a hemispherical shape. The round and / or curved outer surface portions can facilitate contact with the left atrial wall.

[0084] In some instances, the flow-reducing device 1000 can comprise an inflation port 1030. In some instances, the inflation port 1030 can be configured to be anchored to a portion of the left atrial wall. The inflation port 1030 can comprise a central lumen 1036 in fluid communication with the inner chamber 1020 of the flowreducing member 1002 to allow delivery of inflation fluid into the inner chamber1020. For example, an inflation port wall portion 1038 can at least partially define the central lumen 1036. Inflation fluid can be delivered into and / or withdrawn from the inner chamber 1020 through the central lumen 1036 of the inflation port 1030 to inflate and / or deflate the inflatable flow-reducing member 1002. In some instances, a first end portion 1032 of the inflation port 1030 can be coupled to the inflatable flowreducing member 1002. In some instances, a second end portion 1034 of the inflation port 1030 can be configured to be coupled to the left atrial wall. In some instances, the inflation port 1030 can be integrally formed with the inflatable flow-reducing member 1002. For example, the wall portion 1010 of the inflatable flow-reducing member 1002 and the inflation port wall portion 1038 can be integrally formed.

[0085] In some instances, the inflatable flow-reducing member 1002 can comprise an inflatable balloon. In some instances, the inflatable flow-reducing member 1002 can be an inflatable balloon, including an inflatable balloon comprising one or more curved and / or round surface portions. For example, the inflatable flowreducing member 1002 can comprise a spherical or substantially spherical inflatable balloon. One or more outer surface portions of the spherical inflatable balloon can be configured to contact respective inner surface portions of the left atrial wall and / or one or more of the pulmonary vein ostia to prevent or reduce retrograde blood flow into the respective pulmonary vein.

[0086] The flow-reducing device 1000 can comprise an anchor 1070 configured to couple the inflatable flow-reducing member 1002 to a wall portion of the left atrium 2. In some instances, the flow-reducing device 1000 can comprise a plurality of anchors 1070. For example, the flow-reducing device 1000 can comprise two anchors 1070. A first end portion 1072 of each anchor 1070 can be configured to be coupled to the inflatable flow-reducing member 1002 and a second end portion 1074 can be configured to be coupled to a wall portion of the left atrium 2. In some instances, the anchor 1070, such as the second end portion 1074, can comprise a spiral anchor portion 1080. The spiral anchor portion 1080 can be configured to be secured to a portion of the left atrial wall. One or more portions of each anchor 1070 can be foldable and / or stretchable, for example to accommodate the contraction in the cardiac muscles. In some instances, a medial portion 1076 of each anchor 1070 can comprise a tether, such as a suture. As described in further detail herein, the tether can fold and / or unfold, and / or retract and / or stretch to facilitate securing the inflatableflow-reducing member 1002 to the left atrial wall during systole and diastole, respectively.

[0087] In some instances, the plurality of anchors 1070 can be configured to be coupled to the inflatable flow-reducing member 1002 at evenly distributed positions. In some instances, the inflation port 1030 and the two anchors 1070 can be coupled to the inflatable flow-reducing member 1002 at positions that are equidistant from one another. In alternative instances, a flow-reducing device 1000 can comprise more than two anchors. In some instances, a flow-reducing device can have a single anchor.

[0088] Referring to Figure 10A, during atrial systole, the inflatable flowreducing member 1002, such as an occluding portion 1004, can occlude or substantially occlude one or more of the ostia 24, 25, 26, 27 of the pulmonary veins to prevent or reduce retrograde blood flow into the respective pulmonary vein. Contraction of cardiac muscle during atrial systole can cause one or more portions of the outer surface 1014 to contact the left atrial wall and / or pulmonary vein ostia. For example, the inflatable flow-reducing member 1002 can comprise respective occluding portions 1004 for occluding each of the four ostia 24, 25, 26, 27. Each of the occluding portions 1004 can contact respective portions of the left atrial wall adjacent to the pulmonary vein ostia and / or the pulmonary vein ostia to occlude or substantially occlude the ostia. The inflatable flow-reducing member 1002 can be sized to facilitate desired contact between the inflatable flow-reducing member 1002 and the atrial wall portions and / or pulmonary vein ostia during atrial systole, while allowing sufficient blood flow during atrial diastole. In some instances, the inflatable flow-reducing member 1002 can have a volume of about 10 milliliters (mL) to about 60 milliliters (mL), including about 20 milliliters (mL) to about 50 milliliters (mL), and about 20 milliliters (mL) to about 40 milliliters (mL).

[0089] The inflatable flow-reducing member 1002 can be deployed into the left atrium 2 such that one or more of the round and / or curved surface portions can be oriented toward portions of the left atrial wall adjacent to the pulmonary vein ostia and / or the pulmonary vein ostia. In some instances, the flow-reducing member 1002 can be centrally positioned within the atrium 2. In some alternative instances, fewer than all of the ostia 24, 25, 26, 27 can be occluded. For example, the inflatable flowreducing member 1002 can be deployed into the left atrium 2 such that one or more of the round and / or curved surface portions can be oriented toward portions of the leftatrial wall adjacent to the pulmonary vein ostia and / or the pulmonary vein ostia to be occluded. The inflatable flow-reducing member 1002 can comprise round and / or curved surface portions, including convexly curved surface portions, configured to engage with respective inner surface portions of the left atrial wall and / or the pulmonary vein ostia. As described herein, one or more portions of the anchors 1070 can comprise a tether. The tether of each of the anchors 1070 can fold and / or shorten during atrial systole to accommodate the contraction in the cardiac muscles. Folding and / or shortening of the tethers can allow contact between the occluding portions 1004 and the left atrial wall.

[0090] Referring to Figure 10B, during atrial diastole, the inflatable flowreducing member 1002, including one or more of the occluding portions 1004, can be spaced from the inner surface portion of the left atrial wall. During atrial diastole, the inflatable flow-reducing member 1002 can be configured to allow forward blood flow from the pulmonary veins into the left atrium 2. Space between the inflatable flowreducing member 1002 and wall portions of the left atrium 2 can facilitate forward blood flow through the ostia 24, 25, 26, 27. The tether of each of the anchors 1070 can unfold and / or stretch during atrial diastole to accommodate relaxation of the cardiac muscles. Unfolding and / or stretching of the tethers can provide the space between the occluding portions 1004 and the left atrial wall.

[0091] Figures 11A and 1 IB provide cut-away views of a left atrium 2 of a heart 1 and four pulmonary veins 20, 21, 22, 23 that open into the left atrium 2, and a flow-reducing device 1100 deployed to the left atrium 2 and pulmonary veins 20, 21, 22, 23. Figure 11A shows the flow-reducing device 1100 during atrial systole and Figure 1 IB shows the flow-reducing device 1100 during atrial diastole. The flowreducing device 1100 can comprise an inflatable flow-reducing member 1102 comprising a central portion 1110 configured to be disposed within the left atrium 2. The inflatable flow-reducing member 1102 can comprise one or more protrusions 1150 extending from the central portion 1110. For example, the inflatable flowreducing member 1102 can comprise four protrusions 1150 extending from the central portion 1110. Each of the four protrusions 1150 can be configured to be at least partially disposed within a respective pulmonary vein. Alternatively, an inflatable flow-reducing member can comprise fewer than four protrusions, including one, two or three protrusions. The central portion 1110 can define an inner central chamber 1120. Each of the four protrusions 1150 can define a respective inner protrusionchamber 1170. For example, each protrusion 1150 can comprise a wall portion 1160 comprising an inner surface 1162 configured to at least partially define the inner protrusion chamber 1170. Portions of an outer surface 1164 of the wall portion 1160 can be configured to engage respective wall portions of the pulmonary vein. The inner central chamber 1120 can be in fluid communication with each of the inner protrusion chambers 1170 such that an inflation fluid can travel between the inner central chamber 1120 and the inner protrusion chambers 1170. For example, as described in further detail herein, compression of the central portion 1110 can cause inflation fluid to travel from the inner central chamber 1120 to one or more of the inner protrusion chambers 1170, thereby inflating the one or more of the protrusions 1150. The central portion 1110 can assume a deflated state while one or more of the protrusions 1150 assume an inflated state. Once the compressive force upon the central portion 1110 is removed, inflation fluid can travel back into the inner central chamber 1120, thereby causing the protrusions 1150 to return to a deflated state.

[0092] The central portion 1110 can comprise a wall portion 1112 with an inner surface 1114 that can at least partially define the inner central chamber 1120. An outer surface 1116 of the wall portion 1112 can be configured to be oriented toward respective portions of the left atrial wall. In some instances, one or more portions of an outer surface 1116 of the wall portion 1112 can be configured to contact portions of the inner surface the left atrial wall, such as during atrial systole. In some instances, the outer surface 1116 can comprise one or more round and / or curved outer surface portions. The outer surface 1116 can comprise round and / or curved surface portions, including convexly curved surface portions, configured to engage with respective inner surface of the left atrial wall. In some instances, the central portion 1110 can assume a spherical configuration. In some instances, the central portion 1110 can assume another ellipsoid configuration. In some instances, the central portion 1110 can have a partial ellipsoid configuration, including a partially spherical shape, such as a hemispherical shape. The round and / or curved outer surface portions can facilitate contact with the left atrial wall.

[0093] Each of the protrusions 1150 can extend from a position on the central portion 1110 such that the protrusions 1150 can be disposed within the respective pulmonary vein when the flow-reducing device 1100 is deployed into the left atrium 2. In some instances, the protrusions 1150 can extend from portions of the outer surface 1116 comprising a curvature to facilitate engagement of the outersurface 1116 and the left atrial wall when the protrusions 1150 are disposed at least partially within the respective pulmonary vein. In some instances, each protrusion 1150 can comprise a shape and / or size configured to allow occlusion or substantial occlusion of a respective pulmonary vein while the protrusion 1150 is in the inflated state. Referring to Figure 11A, in some instances, each protrusion 1150 can comprise a first portion 1152 having a lateral dimension, such as a diameter, larger than that of a second portion 1154. For example, the first portion 1152 can extend along a first portion of a longitudinal dimension of the protrusion 1150 and the second portion 1154 can extend along a second portion of the longitudinal dimension. The first portion 1152 can be configured to be disposed further into the pulmonary vein than the second portion 1154. The lateral dimension can be perpendicular or substantially perpendicular to the longitudinal dimension. The larger lateral dimension of the first portion 1152 can facilitate occlusion of the pulmonary vein. In some instances, the first portion 1152 can have a ball and / or partial ball configuration and the second portion 1154 can have a cylindrical configuration. In some instances, the lateral dimension, such as a diameter, of the first portion 1152 while the protrusion 1150 is in the inflated state, can be about 0.5 centimeters (cm) to about 3 centimeters (cm), including about 1 centimeter (cm) to about 2 centimeters (cm). Alternatively, each protrusion 1150 can comprise a uniform or substantially uniform lateral dimension along the entire or substantially entire longitudinal dimension.

[0094] In some instances, the protrusions 1150 can be integrally formed with the central portion 1110. For example, the inflatable flow-reducing member 1102 can comprise a central portion 1110 having a spherical configuration and the four protrusions 1150 extending from the spherical central portion 1110.

[0095] Referring to Figure 11 A, during atrial systole, contraction of cardiac muscles of the left atrium 2 can cause one or more portions of the left atrial wall to contact and compress at least a portion of the central portion 1110. Compression of the central portion 1110 can cause inflation fluid to transfer from the inner central chamber 1120 into one or more of the protrusions 1150. One or more portions of the outer surface 1116 can be configured to contact the left atrial wall during atrial systole such that the central portion can be compressed by the left atrial wall. A size of the central portion 1110 can be selected to facilitate desired contact between the central portion 1110 and the atrial wall portions during atrial systole, while allowing sufficient blood flow during atrial diastole. In some instances, thecentral portion 1110 can have a volume, during atrial systole, of about 10 milliliters (mL) to about 60 milliliters (mL), including about 20 milliliters (mL) to about 50 milliliters (mL), and about 20 milliliters (mL) to about 40 milliliters (mL). The inflation fluid can be transferred from the central portion 1110 to one or more of the protrusions 1150. The central portion 1110 can assume a deflated state. The one or more protrusions 1150 can assume an inflated state, thereby occluding or substantially occluding the respective pulmonary vein. In some instances, the four protrusions 1150 can assume an inflated state. The four protrusions 1150 in the inflated state can prevent or reduce retrograde blood flow into and / or through the pulmonary veins 20, 21, 22, 23. In some instances, the four protrusions 1150 in the inflated state can occlude or substantially occlude the four pulmonary veins.

[0096] Referring to Figure 1 IB, during atrial diastole, the left atrial wall does not compress the central portion 1110. In some instances, the left atrial wall is not in contact with the central portion 1110 during atrial diastole. At least a portion of the outer surface 1116 of the central portion 1110 can be spaced by the left atrial wall during atrial diastole. The central portion 1110 can assume an inflated state. For example, after compressive force is removed from the central portion 1110, inflation fluid can travel from the inner protrusion chambers 1170 into the inner central chamber 1120. The one or more protrusions 1150 can assume a deflated state. In some instances, the central portion 1110 can have a volume, during atrial diastole, of about 15 milliliters (mL) to about 65 milliliters (mL), including about 25 milliliters (mL) to about 55 milliliters (mL), and about 25 milliliters (mL) to about 45 milliliters (mL). While the protrusions 1150 are in the deflated state, forward blood flow can be allowed to flow from the pulmonary veins 20, 21, 22, 23 into the left atrium 2. The flow-reducing member 1102, such as the protrusions 1150, can be configured to occlude less than about 80%, including about 40% to about 80%, and about 60% to about 80%, of a lateral cross-sectional area of the pulmonary vein during atrial diastole. For example, the low-reducing member 1102, such as the protrusions 1150, can block about 40% to about 80%, including about 60% to about 80%, of the lateral cross-sectional area of the pulmonary vein during atrial diastole. Sufficient forward blood flow can pass around the protrusions in the pulmonary veins 20, 21, 22, 23. Alternatively, the left atrial wall can be in contact with one or more portions of the central portion 1110, such as one or more portions of the outer surface 1116, during atrial diastole without or substantially without compressing the central portion 1110.

[0097] Figures 12A, 12B and 12C show a flow-reducing device 1200 comprising an occlusion member 1202 configured to be positioned within a left atrium 2. Figures 12A and 12B provides a cut-away view of a left atrium of a heart 1 and a first and a second pulmonary vein 20, 21 that open into the left atrium 2, and side views of the flow-reducing device 1200. Figure 12A shows the occlusion member 1202 in a first state where it is at least partially in contact with an inner wall surface of the left atrium 2, and Figure 12B shows the occlusion member 1202 in a second state where it is spaced away from the inner wall surface of the left atrium 2. Figure 12C provides a cut-away view of the left atrium 2 showing ostia 24, 25, 26, 27 of four pulmonary veins that open into the left atrium 2, and a top-down view of the flow-reducing device 1200 in the left atrium 2. The flow-reducing device 1200 can comprise an anchor 1270 configured to be coupled to the occlusion member 1202. The anchor 1270 can facilitate securing the occlusion member 1202 to the left atrial wall.

[0098] The occlusion member 1202 can comprise an occluding portion 1204 configured to be positioned over one or more of the pulmonary vein ostia 24, 25, 26, 27 during atrial systole. The occlusion member 1202 can comprise a plurality of elongate reinforcement rods 1220 coupled to the occluding portion 1204. In some instances, the plurality of elongate reinforcement rods 1220 can be radially arranged. In some instances, the plurality of elongate reinforcement rods 1220 can be coupled to the occluding portion 1204 in a radial pattern. In some instances, the plurality of elongate reinforcement rods 1220 can be flexible, bendable and / or deformable. Although five elongate reinforcement rods 1220 are shown, it will be understood that more or fewer elongate reinforcement rods 1220 can be used (e.g., three, four, or six). In some instances, the occluding portion 1204 can have a pentagonal shape. Alternatively, an occluding portion can have another polygonal (e.g., triangle, rectangle, or hexagonal) or round shape e.g., oval, or circle). For example, a triangular occluding portion can be coupled to three radially extending elongate reinforcement rods, a rectangular occluding portion can be coupled to four radially extending elongate reinforcement rods, or a hexagonal occluding portion can be coupled to six radially extending elongate reinforcement rods. In some instances, a first surface portion 1206 of the occluding portion 1204 can be configured to be oriented toward the left atrial wall. Referring to Figure 12A, during atrial systole, the occluding portion 1204 can be configured to be at least partially positioned againstinner surface portion of the left atrial wall and / or over the pulmonary vein ostia, occluding or substantially occluding one or more of the pulmonary vein ostia. The occluding portion 1204 can prevent or reduce retrograde blood flow into the pulmonary veins. For example, retrograde blood flow can push against a second surface 1208 of the occluding portion 1204, pushing the occluding portion 1204, including the first surface 1206, against the left atrial wall.

[0099] The occluding portion 1204 can comprise a deformable material 1230. The deformable material 1230 can be foldable and / or stretchable. In some instances, the deformable material 1230 can comprise a fabric material. The plurality of elongate reinforcement rods 1220 can be coupled to the deformable material 1230, including coupled to a first surface portion 1240, a second surface portion 1242 and / or be embedded at least partially within the deformable material 1230. In some instances, the plurality of elongate reinforcement rods 1220 can be coupled to the deformable material 1230 in a radial pattern. For example, a first end portion 1222 of each of the plurality of elongate reinforcement rods 1220 can be at or proximate to a center portion 1232 of the deformable material 1230. A second end portion 1224 of each of the plurality of elongate reinforcement rods 1220 can be at or proximate to an edge portion 1234 of the deformable material 1230. In some instances, each of the plurality of elongate reinforcement rods 1220 can extend from the center portion 1232, including a center 1236, to the edge portion 1234, including an edge 1238, of the deformable material 1230. In some instances, the occlusion member 1202 can comprise an umbrella canopy configuration, including an umbrella canopy configuration having a pentagon shape. The plurality of elongate reinforcement rods 1220 can facilitate maintaining the deformable material 1230 disposed over the ostia 24, 25, 26, 27 while disposed within the left atrium 2.

[0100] The first surface 1240 of the deformable material 1230 can be configured to be oriented toward the left atrial wall. At least a portion of the first surface 1240 can be positioned over and in contact with an inner surface portion of a left atrial wall and / or the pulmonary vein ostia during atrial systole. The second surface 1242 of the deformable material 1230 can be configured to be oriented away from the left atrial wall. For example, force exerted by retrograde blood flow against the second surface 1242 can push the deformable material 1230, including the first surface 1240, towards the left atrial wall such that at least a portion of the first surface 1240 can be against the left atrial wall. During diastole, as shown in Figure 12B, thefirst surface 1240 can be spaced away from the left atrial wall to allow forward blood flow from the pulmonary veins into the left atrium. For example, force exerted upon the first surface 1240 by forward blood flow during atrial diastole can push the deformable material 1230 away from the left atrial wall.

[0101] In some instances, the anchor 1270 can comprise a coil spring 1280. A first end portion 1282 of the coil spring 1280 can be coupled to the occlusion member 1202. A second end portion 1284 of the coil spring 1280 can be configured to be coupled to the left atrial wall. The coil spring 1280 can be configured to be in a relaxed state and position the occlusion member 1202 away from the left atrial wall during atrial diastole. The coil spring can be in a compressed state to allow at least a portion of the occlusion member 1202 to contact the left atrial wall during atrial systole.

[0102] In some instances, the second surface 1208 of the occluding portion 1204 can comprise a concave curvature configured to be oriented toward the left atrium 2. For example, the second surface 1242 of the deformable material 1230 can comprise the concave curvature. In some instances, the plurality of elongate reinforcement rods 1220 can extend along at least a portion of the concave curvature. In some instances, a center portion 1212, including a center 1216, of the occluding portion 1204 can be configured to be positioned further away from a respective portion of the left atrial wall relative to that of an edge portion 1214, including an edge 1218 of the occluding portion 1204, such as to accommodate the anchor 1270. For example, a center portion 1232 of the deformable material 1230 can be configured to be positioned further away from a respective portion of the left atrial wall relative to that of the edge portion 1234.

[0103] Referring to Figure 12C, in some instances, the occluding portion 1204 can be over all four ostia 24, 25, 26, 27 of the pulmonary veins. In some instances, the occluding portion 1204 can be configured to be positioned over a portion of the left atrial wall that is centered relative to the four ostia 24, 25, 26, 27. The center portion 1212 of the occluding portion 1204, including the center portion 1232 of the deformable material 1230, can be positioned over a portion of the left atrial wall that is equidistant or substantially equidistant to the four ostia 24, 25, 26, 27. For example, the portion of the left atrial wall to which the anchor 1270 is coupled can be equidistant or substantially equidistant to the four ostia 24, 25, 26, 27. In some instances, the occlusion portion 1204, including the deformable material 1230, can besized to allow coverage of all four of the ostia 24, 25, 26, 27. Alternatively, fewer than all four ostia 24, 25, 26, 27 are covered by an occlusion portion, including one, two or three of the ostia. In some instances, the occlusion portion 1204, including the deformable material 1230, can have an area of about 5 square centimeters (cm2) to about 60 square centimeters (cm2), including about 10 square centimeters (cm2) to about 55 square centimeters (cm2), about 15 square centimeters (cm2) to about 55 square centimeters (cm2), and about 20 square centimeters (cm2) to about 30 square centimeters (cm2). In some instances, the deformable material 1230 can have a single and / or unitary sheet configuration. Alternatively, the deformable material 1230 can comprise a plurality of individual panel portions. For example, individual panel portions, including individual panel portions having a triangular shape, can be coupled to respective adjacent elongate reinforcement rods 1220.

[0104] In alternative instances, an occluding portion 1204 can be configured to cover fewer than all four ostia 24, 25, 26, 27. A size and / or position to which the flow-reducing device 1200 is deployed can be determined based at least in part on the number of ostia the device covers.

[0105] Figure 13 provides a cut-away view of a left atrium 2 and ostia 24, 25, 26, 27 of four pulmonary veins that open into the left atrium 2, and a top-down view of the flow -reducing device 1300 in the left atrium 2. The flow-reducing device 1300 can comprise an occlusion member 1302. The occlusion member 1302 can be positioned over one or more of the pulmonary vein ostia 24, 25, 26, 27. Figure 13 shows the occlusion member 1302 placed over all of the ostia 24, 25, 26, 27. During atrial systole, blood flow, including retrograde blood flow, in the left atrium 2 can push against the occlusion member 1302, positioning the occlusion member 1302 over and / or sealing the ostia 24, 25, 26, 27 to prevent or reduce retrograde blood into the pulmonary veins. For example, the occlusion member 1302 can comprise a first surface 1306 configured to be oriented away from the wall portion of the left atrium 2 and a second surface 1304 configured to be oriented toward the wall portion of the left atrium 2. Force exerted upon the first surface 1306 can push the occlusion member 1302 against the left atrial wall. For example, at least a portion of the second surface 1304 can be over and in contact with the left atrial wall. The occlusion member 1302 can be configured to occlude or substantially occlude all four pulmonary vein ostia 24, 25, 26, 27 during atrial systole. During atrial diastole, forward blood flow can push against the second surface 1304 of the occlusionmember 1302 to push the occlusion member 1302, including the second surface 1304, away from the wall portion of the left atrium 2 and / or the pulmonary vein ostia 24, 25, 26, 27. The occlusion member 1302 can thereby allow blood flow into the left atrium 2 during atrial diastole.

[0106] In some instances, the occlusion member 1302 can have a sheet configuration. For example, the occlusion member 1302 can comprise a bendable and / or flexible sheet 1310. In some instances, the occlusion member 1302 can comprise a sheet of fabric. In some instances, the bendable and / or flexible sheet 1310 can comprise a polymeric material, including silicone and / or rubber. A first surface 1312 of the sheet 1310 can be configured to be oriented away from the left atrial wall. A second surface 1314 of the sheet 1310 can be configured to be oriented toward the left atrial wall. During atrial systole, retrograde blood flow can exert force against the first surface 1312 of the sheet 1310, pushing the sheet 1310 over and / or against the ostia 24, 25, 26, 27 to prevent or reduce retrograde blood into the pulmonary veins. In some instance, the sheet 1310 can seal or substantially seal the ostia 24, 25, 26, 27 during atrial systole. During atrial diastole, force from forward blood flow can push against the second surface 1314 of the sheet 1310 to push the sheet 1310 away from the left atrial wall and / or the pulmonary vein ostia 24, 25, 26, 27. The sheet 1310 can thereby allow blood flow into the left atrium 2 during atrial diastole.

[0107] In some instances, the flow-reducing device 1300 can comprise a plurality of anchors 1370 configured to couple the occlusion member 1302 to the left atrial wall. In some instances, each of the plurality of anchors 1370 can comprise a tether and / or suture configured to stitch the occlusion member 1302 to the left atrial wall. Figure 13 shows four anchors 1370 coupling the occlusion member 1302 to the left atrial wall. In some instances, the occlusion member 1302 can have a rectangular sheet configuration such that an anchor 1370 can be used to secure each corner of the occlusion member 1302. For example, a tether and / or suture can be used to stitch each corner of the sheet to the left atrial wall. It will be understood that an occlusion member 1302 can assume a shape other than the rectangular shape, including a rounded shape (e.g., a circular and / or oval shape) and another polygonal shape (e.g., a pentagonal shape). In some instances, a size of the occlusion member 1302 can be selected to allow coverage of all four of the ostia 24, 25, 26, 27. Alternatively, fewer than all four ostia 24, 25, 26, 27 are covered by an occlusion member, including one, two or three. In some instances, the occlusion member 1302 can assume a sheetconfiguration having an area of about 5 square centimeters (cm2) to about 60 square centimeters (cm2), including about 10 square centimeters (cm2) to about 55 square centimeters (cm2), about 15 square centimeters (cm2) to about 55 square centimeters (cm2), and about 20 square centimeters (cm2) to about 30 square centimeters (cm2).

[0108] Figures 14 and 15 provide cut-away views of a heart 1, and four pulmonary veins 20, 21, 22, 23 feeding into a left atrium 2, where shunt devices are deployed to provide blood flow between adjacent pulmonary veins. The shunt devices can be flow-reducing devices configured to reduce or eliminate retrograde blood flow through the pulmonary veins 20, 21, 22, 23 to the lungs. A first shunt device 1400, 1500 can be coupled a first right superior pulmonary vein 20 and a first right inferior pulmonary vein 21. The first shunt device 1400, 1500 can provide blood flow between the first right superior and inferior pulmonary veins 20, 21. A second shunt device 1450, 1550 can be coupled to a second right superior pulmonary vein 23 and a second right inferior pulmonary vein 22. The second shunt device 1450, 1550 can provide blood flow between the second right superior and inferior pulmonary veins 23, 22.

[0109] In some instances, allowing blood flow between pulmonary veins can provide pressure equilibration between the pulmonary veins. In some instances, blood pressure may be higher in a superior pulmonary vein than that in an inferior pulmonary vein. Allowing blood flow between the superior pulmonary vein and the inferior pulmonary vein can facilitate equilibration of pressure between the two. Blood can flow from the pulmonary vein with the higher pressure to the pulmonary vein with the lower pressure, thereby adding compliance to the circulatory system and / or preventing or reducing retrograde flow of blood to the lungs through the pulmonary vein with higher pressure. For example, blood can flow into the left inferior pulmonary vein from the left superior pulmonary vein, or into the right inferior pulmonary vein from the right superior pulmonary vein, instead of creating a higher back pressure in the superior pulmonary veins, as blood flow is redirected to the inferior pulmonary vein with lower pressure.

[0110] Each of the shunt devices 1400, 1500, 1450, 1550 can comprise a central lumen 1402, 1502, 1452, 1552 extending between a first end opening 1404, 1504, 1454, 1554 at a first end 1408, 1508, 1458, 1558 and a second end opening 1406, 1506, 1456, 1556 at a second end 1410, 1510, 1460, 1560. In some instances, the shunt devices 1400, 1500, 1450, 1550 can comprise a cylindrical tubularconfiguration. Blood can flow through the central lumens 1402, 1502, 1452, 1552 to provide the pressure equilibration.

[0111] One or more dimensions of shunt devices can be selected based on the anatomy into which the devices are deployed. For example, the first and second shunt devices 1500, 1550 shown in Figure 15 can have a longitudinal dimension, such as length, shorter than that of the shunt devices 1400, 1450 shown in Figure 14. The first and second shunt devices 1500, 1550 shown in Figure 15 can be deployed to provide blood flow between superior and inferior pulmonary veins that are more closely disposed to one another than those shown in Figure 14, such that shorter shunt devices can be used. In some instances, a length of a shunt device can be about 0.5 centimeters (cm) to about 5 centimeters (cm), including about 0.5 centimeters (cm) to about 4 centimeters (cm), and about 1 centimeter (cm) to about 3 centimeters (cm).

[0112] Figure 16 is a process flow diagram showing an example of a process 1600 of implanting a shunt device, including the shunt devices 1400, 1500, 1450, 1550 described with reference to Figures 14 and 15. In block 1602, the method can involve providing a shunt device comprising a central lumen extending from a first end opening to a second end opening. In block 1604, the method can involve coupling the first end opening of the shunt device to a position on a first superior pulmonary vein to provide fluid communication between the central lumen and the first superior pulmonary vein. In block 1606, the method can involve coupling the second end opening of the shunt device to a position on a first inferior pulmonary vein to provide fluid communication between the central lumen and the first inferior pulmonary vein, thereby allowing blood flow between the first superior and inferior pulmonary veins.

[0113] In some instances, the first superior pulmonary vein can be a first right superior pulmonary vein and the first inferior pulmonary vein can be a first right inferior pulmonary vein. Alternatively, the first superior pulmonary vein can be a first left superior pulmonary vein and the first inferior pulmonary vein can be a first left inferior pulmonary vein.

[0114] In some instances, the method can involve providing a second shunt device comprising a central lumen extending from a first end opening to a second end opening. The method can involve coupling the first end opening of the second shunt device to a position on a second superior pulmonary vein to provide fluid communication between the central lumen and the second superior pulmonaryvein. The method can involve coupling the second end opening of the second shunt device to a position on a second inferior pulmonary vein to provide fluid communication between the central lumen of the second shunt device and the second inferior pulmonary vein, thereby allowing blood flow between the second superior and inferior pulmonary veins. In some instances, the second superior pulmonary vein can a second left superior pulmonary vein and the second inferior pulmonary vein can be a second left inferior pulmonary vein. Alternatively, the second superior pulmonary vein can be a second right superior pulmonary vein and the second inferior pulmonary vein can be a second right inferior pulmonary vein.

[0115] Figure 17 is a cut-away view of an example of a flow-reducing device 1700 comprising a piezoelectric material composition 1750. The flow-reducing device 1700 can comprise a housing 1710 comprising an internal chamber 1740 configured to receive and / or house the piezoelectric material composition 1750. The piezoelectric material composition 1750 can be configured to be one or more of an energy source, sensor, and actuator. In some instances, the piezoelectric material composition 1750 can comprise one or more piezoelectric materials configured to perform one or more of generate electricity to power one or more functions of the flow-reducing device 1700, detect retrograde pressure waves, including retrograde V- waves, and generate counter waves to reduce or eliminate effect of the retrograde pressure waves to thereby reduce or prevent retrograde blood flow into the pulmonary veins.

[0116] In some instances, the piezoelectric material composition 1750 can comprise a first piezoelectric material 1752 configured to serve as a battery, such as a flexible battery, for the flow-reducing device 1700. For example, the first piezoelectric material 1752 can generate electricity using wall motion of the left atrial wall, transforming wall motion of the left atrial wall into electricity to power one or more functions of the device 1700. In some instances, the housing 1710 can comprise a wall portion 1712 configured to be positioned over and in contact with a respective portion of the left atrial wall so as to allow the wall motion of the left atrial wall portion to deform the first piezoelectric material 1752. For example, the housing 1710 can comprise a plurality of anchor portions 1720 configured to allow the housing device 1700 to be secured to a portion of the left atrial wall. In some instances, the wall portion 1712 of the housing 1710 can be flexible, bendable and / or deformable to allow the left atrial wall motion to be transferred to the first piezoelectric material1752, causing deformation of the first piezoelectric material 1752. Deformation of the first piezoelectric material 1752 can thereby cause the first piezoelectric material 1752 to generate electrical currents, allowing transformation of the left atrial wall motion into electricity. In some instances, the first piezoelectric material 1752 can be coupled to, including over and in contact with, the wall portion 1712 of the housing to facilitate deformation of the first piezoelectric material in response to deformation of the wall portion 1712 by the left atrial wall motion.

[0117] In some instances, the piezoelectric material composition 1750 can comprise a second piezoelectric material 1754 configured to be a sensor. For example, the second piezoelectric material 1754 can be configured to sense retrograde pressure waves, such as the frequency and / or amplitude of the pressure waves, in the left atrium. In some instances, force generated by the pressure waves can be converted into a voltage for detection by the sensor.

[0118] In some instances, the piezoelectric material composition 1750 can comprise a third piezoelectric material configured to be actuator. For example, the third piezoelectric material 1756 can generate counter waves to reduce or cancel effects of the detected pressure waves, such as by using an inverse piezoelectric effect. An electrical signal can be applied to the third piezoelectric material 1756 to cause deformation of the third piezoelectric material 1756. Deformation of the third piezoelectric material 1756 can be used to generate the counter waves. In some instances, one or more wave-generating components, such as a plate and / or sheet member, can be coupled to the third piezoelectric material 1756 for generating the desired vibrations. The counter waves can be generated in response the detected pressure waves, such as pressure waves sensed by the second piezoelectric material 1754. Effects of the retrograde pressure waves, such as retrograde V-waves, can be canceled or diminished. The counter waves can thereby reduce or eliminate retrograde pressure waves to prevent or reduce retrograde blood flow into the pulmonary veins.

[0119] It will be understood that the arrangement and / or configuration of the piezoelectric materials in Figure 17 are shown for illustrative purposes only. For example, although the piezoelectric composition 1750 is shown as comprising three piezoelectric materials, more or fewer different piezoelectric materials can be used. Each of the first, second and third piezoelectric materials 1752, 1754, 1756 can be a single type of piezoelectric material and / or comprise a composition of different types of piezoelectric materials. The order and / or arrangement of the layers and / or sheets ofpiezoelectric materials in a stacked configuration are for illustrative purposes only. The layers and / or sheets can be in a different order and / or one or more of the piezoelectric materials can be laterally spaced from other piezoelectric materials, rather than in a vertically stacked configuration.

[0120] Figure 18 provides a cut-away view of a left atrium 2 a heart 1, and the flow-reducing device 1700 described with reference to Figure 17 deployed into the left atrium 2. Figure 18 shows anchors 1730 coupling each of the anchoring portions 1720 to a respective wall portion of the left atrium 2. In some instances, the flow-reducing device 1700 can comprise four anchoring portions 1720. Each anchoring portion 1720 can comprise an opening extending through a respective portion of the housing 1710. For example, the housing 1710 can comprise a rectangular or substantially rectangular shape. Each corner of the rectangle can comprise an anchoring portion 1720. In some instances, the anchors 1730 can comprise a tether and / or suture. For example, one or more sutures can be passed through each opening of the anchoring portions 1720 to secure the device 1700 to the left atrial wall.

[0121] In some instances, the flow-reducing device 1700 can be coupled to a left atrial wall portion between the four pulmonary vein ostia 24, 25, 26, 27 that provide blood flow into the left atrium 2. A location of the flow-reducing device 1700 can be selected to provide the desired cancellation and / or reduction of retrograde pressure waves. Figure 18 shows one flow-reducing device 1700 being used to reduce or eliminate retrograde blood flow into the four pulmonary veins. In some instances, the flow-reducing device 1700 can be configured to be coupled to a left atrial wall portion equidistant from the four pulmonary vein ostia 24, 25, 26, 27. For example, the flow-reducing device 1700 can be at a position on the left atrial wall that is centered relative to the ostia 24, 25, 26, 27.

[0122] Although Figure 18 shows one flow-reducing device being used, in some instances, more flow-reducing devices can be used to reduce or prevent retrograde blood flow into the four pulmonary veins. In some instances, a flowreducing device can be positioned closer to one or more target pulmonary vein ostia, relative to one or more of the other pulmonary vein ostia, for example to provide desired retrograde pressure wave reduction and / or elimination to reduce or prevent retrograde blood flow into the target pulmonary veins. In some instances, a flowreducing devices can be coupled to the left atrial wall at respective positions for eachof the pulmonary vein ostia such that four flow-reducing devices are used to reduce or eliminate retrograde blood flow into the four pulmonary veins.

[0123] Figure 19 is a perspective view of an example of a flow-reducing device 1900 comprising a tubular reflector member 1902. The flow-reducing device 1900 can be positioned within a pulmonary vein to reduce or prevent retrograde blood flow through the pulmonary vein. In some instances, the flow-reducing device 1900 can provide wave reflection points for retrograde pressure waves within the pulmonary vein, thereby reducing or preventing propagation of retrograde pressure waves through the pulmonary vein. Reducing or preventing propagation of retrograde pressure waves through the pulmonary vein can reduce or prevent retrograde blood flow through the pulmonary vein from the left atrium 2 into the lungs.

[0124] The tubular reflector member 1902 can comprise a frame 1904 having a tubular configuration. In some instances, the frame 1904 can comprise an expandable frame, such as a radially expandable frame. A lateral dimension, such as a diameter, can increase and / or decrease, including reversibly increase and / or decrease. In some instances, the frame 1904 can comprise a stent and / or ring, including an expandable stent and / or ring. For example, delivery of the flow-reducing device 1900 can comprise deploying the tubular reflector member 1902 in a first expanded state to a position proximate to or at the target location. The tubular reflector member 1902 can be expanded to a second expanded state, such as by using an inflatable balloon, at the target location. In some instances, the tubular reflector member 1902 can be in the first expanded state or a state that is less expanded than the second expanded state during advancement to the target location. In some instances, the tubular reflector member 1902 can be in the first expanded state while wave analysis is performed for selecting the location of deployment. For example, after the desired location is determined, the inflatable balloon can expand the tubular reflector member 1902 to a second expanded state.

[0125] In some instances, the flow-reducing device 1900 can comprise a first material 1910 over an inner surface 1906 (not shown) of the frame 1904 and / or a second material 1912 over an outer surface 1908 (not shown) of the frame 1904. For example, tubular reflector member 1902 can comprise the frame 1904 sandwiched between the first and second materials 1910, 1912. The first and second materials 1910, 1912 may be the same material or different materials. In some instances, the tubular reflector member 1902 can comprise a central lumen 1928 extendingtherethrough, from a first end opening 1924 at a first end 1920 to a second end opening 1926 at a second end 1922 of the tubular reflector member 1902. In some instances, an inwardly oriented surface 1914 of the first material 1910 can at least partially define the central lumen 1928. An outwardly oriented surface 1916 of the second material 1912 can be configured to be oriented toward inner wall portions of the pulmonary vein. 0126] In some instances, the frame 1904 can assume a cylindrical shape. In some instances, the frame 1904 can comprise a metal frame. For example, flowreducing device 1900 can comprise a cylindrically shaped metal frame and a covering over at least a portion of the cylindrical metal frame, such as a cover over an inner and outer surface of the frame. In some instances, a width, such as a diameter, including an outer diameter, of the tubular reflector member 1902 in the second expanded state can be about 0.5 centimeters (cm) to about 4 centimeters (cm), including about 1 centimeter (cm) to about 3 centimeters (cm), and about 1 centimeter (cm) to about 2 centimeters (cm). For example, an outer diameter of the tubular reflector member 1902 in the second expanded state can allow secure engagement between the tubular reflector member 1902 and the inner wall portions of the pulmonary vein. A diameter of the central lumen 1928 can be selected to allow sufficient blood flow therethrough while allowing sufficient thickness in sidewall portions of the tubular reflector member 1902 for the reflection of retrograde pressure waves.

[0127] Figure 20 provides a cut-away view of a left atrium 2 of a heart 1 and four pulmonary veins 20, 21, 22, 23 that open into the left atrium 2, and a flowreducing device 1900 deployed into each of the four pulmonary veins 20, 21, 22, 23. Each tubular reflector member 1902 can be positioned within a pulmonary vein such that an orientation of the central lumen 1928 can be aligned with the blood flow path within the pulmonary vein. In some instances, the first end 1920 of the tubular reflector member 1902 can be oriented toward the left atrium 2 and the second end 1922 of the tubular reflector member 1902 can be oriented away from the left atrium 2. As described herein, the tubular reflector member 1902 can comprise a radially expandable frame. In some instances, the radially expandable frame can exert an outwardly directed radial force upon respective portions of the wall of the pulmonary vein. The outwardly directed radial force can facilitate secure positioning of the tubular reflector member 1902 at a target site within the pulmonary vein. Forexample, the outwardly oriented surface 1916 of the second material 1912 can engage with respective portions of the wall of the pulmonary vein.

[0128] In some instances, the flow-reducing device 1900 can provide pressure wave reflection points in a pulmonary vein, for example modifying resonance properties of the pulmonary vein to thereby reduce or eliminate propagation of retrograde pressure waves within the pulmonary vein. Reducing or eliminating propagation of retrograde pressure waves within the pulmonary vein can reduce or prevent retrograde blood flow through the pulmonary vein from the left atrium into the lungs. For example, the tubular reflector member 1902 can reflect retrograde pressure waves traveling along the pulmonary vein. Reflection of the retrograde pressure waves can facilitate reduction or elimination of retrograde blood flow through the pulmonary vein.

[0129] As described in further detail herein, in some instances, a position at which the flow-reducing device 1900 is deployed within the pulmonary vein can be selected to provide desired wave reflection. For example, a distance of the tubular reflector member 1902, such as a distance of the first end 1920, from an ostium in the left atrium of the pulmonary vein, such as an insertion depth, can be selected based at least in part on wave analysis of blood flow in the pulmonary vein and / or left atrium. The wave analysis can be performed prior to insertion of the flow-reducing device 1900 or intraoperatively. In some instances, the distance or insertion depth can be selected such that retrograde blood flow through the pulmonary vein can be eliminated. In some instances, a diameter of the tubular reflector member 1902 can be selected to provide the desire wave reflection.

[0130] One or more features of the four flow-reducing devices 1900 can be different from another one of the devices 1900. For example, a diameter of a tubular reflector member 1902 can be different from that of another tubular reflector member 1902. In some instances, a position of each flow-reducing device 1900 in the four pulmonary veins 20, 21, 22, 23 can be individually selected.

[0131] Figure 21 is a process flow diagram of an example of a process 2100 for deploying the flow-reducing device 1900 described with reference to Figure 19. In block 2102, the method can involve providing a flow-reducing device comprising a tubular reflector member. In block 2104, the method can involve positioning the tubular reflector member into a pulmonary vein at an insertion depth from a pulmonary vein ostium. For example, the tubular reflector member can bepositioned at a distance from an ostium of a pulmonary vein that opens into a left atrium. In block 2106, the method can involve analyzing retrograde wave propagation within the pulmonary vein. Wave analysis can be performed to determine effect of the tubular reflector member has on retrograde blood flow in the pulmonary vein. In block 2108, the method can involve adjusting the insertion depth of the tubular reflector member based at least in part on the wave analysis. In some instances, after desired retrograde blood flow reduction, such as elimination of retrograde blood flow, is achieved at a position, the flow-reducing device can be deployed to the position. For example, the tubular reflector member can be implanted to the selected position that provides desired retrograde flow reduction.

[0132] In some instances, providing the tubular reflector member can comprise providing a cylindrical frame comprising a central lumen extending therethrough, and positioning the central lumen in alignment with a direction of blood flow in the pulmonary vein. In some instances, providing the tubular reflector member can comprise providing a cylindrical frame comprising metal and a covering over at least a portion of the cylindrical frame.

[0133] In some instances, analyzing the retrograde wave propagation can comprise measuring retrograde waves traveling from the left atrium into the pulmonary vein. In some instances, analyzing retrograde wave propagation within the pulmonary vein can comprise visualizing flow patterns of blood flow in one or more portions of vasculature, including one or more portions of the heart, such as the left atrium, and one or more of the pulmonary veins. In some instances, visualizing flow patterns of blood flow can comprise obtaining an MRI (magnetic resonance imaging) of the one or more of the pulmonary veins and / or one or more portions of the heart, such the left atrium. In some instances, obtaining an MRI (magnetic resonance imaging) can comprise obtaining a 4-D MRI (magnetic resonance imaging). The 4-D MRI (magnetic resonance imaging) can measure volumes in the chambers of the heart and / or pulmonary veins, sizes of the chambers of the heart and / or pulmonary veins, geometries and compliances of the chambers of the heart and / or pulmonary veins, and / or blood pressures in the chambers of the heart and / or pulmonary veins. For example, a first MRI (magnetic resonance imaging) can be obtained the one or more of the pulmonary veins and / or one or more portions of the heart.

[0134] In some instances, analyzing retrograde wave propagation within the pulmonary vein can comprise simulating flow patterns of the heart. Thesimulation of the flow patterns in the heart can be generated based on an MRI (magnetic resonance imaging), such as the first MRI (magnetic resonance imaging). This allows the simulation to be patient specific. The simulation will simulate the flow patterns in the heart of the patient, and specifically in the right atrium, the left atrium, and the coronary sinus of the heart. The simulation can also simulate the volumes, sizes, geometries, compliances, and blood pressures of the chambers of the heart based on data from the first MRI. The simulation can be generated using any suitable software program.

[0135] In some instances, analyzing retrograde wave propagation within the pulmonary vein can comprise simulating blood flow in the heart when one or more flow-reducing devices are positioned within a respective pulmonary vein. Simulation of blood flow after a flow-reducing device is positioned within the pulmonary vein can allow adjustment in the positioning and / or sizing of the flowreducing device based at least in part on patient anatomy. For example, the simulation can be performed after one or more tubular reflector members are positioned at or proximate to a target location in a respective pulmonary vein.

[0136] In some instances, adjusting the distance of the flow-reducing device from the pulmonary vein ostium, such as the insertion depth, can comprise positioning the flow-reducing device at a position to reduce or eliminate retrograde wave propagation within the pulmonary vein. For example, adjusting the insertion distance can comprise positioning the tubular reflector member at a position to reduce or eliminate retrograde wave propagation within the pulmonary vein. The position can be selected such that no or a reduced retrograde blood flow occurs. In some instances, the flow-reducing device can be maintained on a delivery system while a target position is selected. For example, the tubular reflector member can be maintained on a delivery catheter and / or inflatable balloon while the target position is determined. The flow-reducing device can be deployed from the delivery system after a position is selected.

[0137] In some instances, after a position for the flow-reducing device is selected, the flow-reducing device can be deployed to the selected position. In some instances, deploying the flow-reducing device can comprise expanding the tubular reflector member to an expanded state configured to securely position the tubular reflector member. In some instances, the tubular reflector member can be expanded to an expanded state to allow engagement of the outwardly oriented surface of thesecond material over the expandable frame with inner surface portions of the pulmonary vein wall. For example, the inflatable balloon of the delivery system can be expanded to expand the tubular reflector member to an expanded state for securing the tubular reflector member within the pulmonary vein.

[0138] In some instances, retrograde wave propagation analysis can be performed after each adjustment in position of the flow-reducing device. For example, one or more subsequent MRI’ s (magnetic resonance imaging) can be obtained to determine whether desired reduction in retrograde blood flow has been achieved. In some instances, retrograde wave propagation analysis can be performed after deployment of the flow-reducing device to the selected position to confirm desired reduction in retrograde blood flow, including confirming that retrograde blood flow is stopped. For example, an MRI (magnetic resonance imaging) can be obtained after deployment of the flow-reducing device to confirm prevention of retrograde blood flow. In some instances, a diameter of the tubular reflector member can be adjusted to provide desired wave propagation.|0139| Figure 22 provides a side cross-sectional view of a flow-reducing device 2200 comprising a damper configured to dampen effects of retrograde pressure waves to thereby prevent or reduce retrograde blood flow into the pulmonary veins. The flow-reducing device 2200 can comprise a damping sheet 2210, and a piston shaft 2220 having a first end portion 1 coupled to the damping sheet 2210 and a second end portion 2224 coupled to a piston head 2230. The damping sheet 2210 can comprise a damping surface 2212 oriented away from the piston head 2230 and a second surface 2214 oriented toward the piston head 2230. In some instances, the second surface 2214 can be opposingly oriented relative to the damping surface 2212. For example, the piston shaft 2220 can be coupled to the second surface 2214 of the damping sheet 2210. The flow-reducing device 2200 can comprise a housing 2270 comprising a chamber 2278 configured to slidably receive the piston head 2230 and a portion of the piston shaft 2220. The housing 2270 can comprise a first end portion 2272 having a sealing end 2240 and a second end portion 2274 comprising an open end 2276. In some instances, the sealing end 2240 and the open end 2276 can be opposingly oriented. The sealing end 2240 can have a piston shaft opening 2248 extending therethrough and configured to slidably receive a respective portion of the piston shaft 2220. The housing 2270 can comprise lateral wall portions 2250. The lateral wall portions 2250 can extend from the sealing end 2240 to the open end 2276.In some instances, a first end 2256 of the lateral wall portion 2250 can be coupled to the sealing end 2240. A second end 2258 of the lateral wall portion 2250 can at least partially form and / or define the open end 2276. In some instances, the housing 2270 can comprise a cylindrical shape, for example assuming an open-ended cylinder configuration.

[0140] The flow-reducing device 2200 can comprise a coil spring 2260 configured to be disposed around at least a portion of the piston shaft 2220 disposed externally of the housing 2270. The coil spring 2260 can comprise a first end 2262 configured to be in contact with the second surface 2214 of the damping sheet 2210. A second end 2264 of the coil spring 2260 can be configured to be in contact with an exterior surface portion 2242 of the sealing end 2240. In some instances, the exterior surface portion 2242 of the sealing end 2240 can be oriented toward, including having an opposing orientation relative to, the second surface 2214 of the damping sheet 2210. For example, the exterior surface portion 2242 of the sealing end 2240 can be configured to be oriented toward the left atrium. The coil spring 2260 can be configured to assume a compressed state in response to force exerted by retrograde pressure waves, including retrograde V-waves, upon the damping surface 2212 of the damping sheet 2210. Force from the retrograde pressure waves can push against the damping sheet 2210, pushing the damping sheet 2210 toward the housing 2270 and translating portions of the piston shaft 2220 into the housing 2270. Portions of the piston shaft 2220 can be slidably disposed through the piston shaft opening 2248, positioning the piston head 2230 toward the open end 2276. Displacing the damping sheet 2210 toward the housing 2270 can compress the coil spring 2260. After force, such as from retrograde pressure waves, exerted upon the damping sheet 2210 is removed, the coil spring 2260 can return to a relaxed state. In the absence of retrograde pressure waves, the coil spring 2260 can expand and assume the relaxed state, thereby causing portions of the piston shaft 2220 to be translated back out of the housing 2270 through the piston shaft opening 2248. The piston head 2230 can be displaced toward the sealing end 2240.

[0141] In some instances, the sealing end 2240 can comprise a first fluid opening 2246 extending therethrough and configured to allow fluid to flow into and out of the chamber 2278 of the housing 2270. In some instances, the piston head 2230 can comprise a second fluid opening 2236 extending therethrough and configured to allow fluid to flow into and out of the chamber 2278. The second fluid opening 2236 can havea size smaller than that of the first fluid opening 2246. In some instances, the first fluid opening 2246 can allow blood to fill the chamber 2278 and the left atrial appendage. Allowing blood to move into and out of the left atrial appendage can allow continuous blood movement to prevent stasis. The second fluid opening 2236 can allow blood to flow into the chamber 2278 as the piston head 2230 is pushed toward the open end 2276. hi some instances, the size of the second fluid opening 2236 can at least in part determine a damping effect provided by the device 2200.

[0142] In some alternative instances, a piston head can comprise a plurality of fluid openings. In some instances, a total size of the plurality of fluid openings of the piston head can be smaller than that of the first fluid opening of a sealing end. In some instances, a sealing end can comprise a plurality of openings. A total size of the plurality of fluid openings of the sealing end can be larger than a total size of the one or more openings of the piston head.

[0143] A volume of the chamber 2278 can be defined at least in part by an inner surface 2244 of the sealing end 2240, an inner surface 2254 of the lateral wall portion 2250, and a first surface 2232 of the piston head 2230. The inner surface 2244 of the sealing end 2240 can be oriented toward the open end 2276, such as the second end 2258 of the lateral wall portion 2250. The first surface 2232 of the piston head 2230 can be oriented toward the sealing end 2240, such as the first end 2256 of the lateral wall portion 2250. A second surface 2234 of the piston head 2230 can be oriented toward the open end 2276. The volume of the chamber 2278 can decrease or increase as the piston head 2230 is translated toward or away from the sealing end 2240, respectively. In some instances, as the volume of the chamber 2278 changes, viscous fluid can enter and / or exit through the first fluid opening 2246 and the second fluid opening 2236. For example, blood can enter and / or exit through the first fluid opening 2246 and the second fluid opening 2236 to provide the damping effect. Force exerted upon the damping sheet 2210 by retrograde waves can push the damping sheet 2210, thereby pushing the piston head 2230, toward the open end 2276. The coil spring 2260 can be compressed as the damping sheet 2210 is pushed by the retrograde waves. The volume of the chamber 2278 can increase as the piston head 2230 is pushed toward the open end 2276. Blood can enter through the first and / or second fluid openings 2246, 2236 as the volume of the chamber 2278 increases. After force exerted by the retrograde waves is removed, the coil spring 2260 can relax and push the damping sheet 2210 away from the housing 2270, thereby translating the pistonhead 2230 toward the sealing end 2240. The volume of the chamber 2278 can decrease as the piston head 2230 is displaced toward the sealing end 2240, causing flood to exit through the first and / or second fluid openings 2246, 2236.

[0144] Figure 23 provides a cut-away view of a heart 1 and deployment of the flow-reducing device 2200 described with reference to Figure 22 to a left atrial appendage 28 of a left atrium 2 of the heart 1. The housing 2270 can be at least partially disposed within the left atrial appendage 28. The first end portion 2272 of the housing 2270 can be oriented toward the left atrium 2. The second end portion 2274 of the housing 2270 can be oriented away from the left atrium 2. The second end portion 2274, including the open end 2276, can be disposed within the left atrial appendage 28. In some instances, the housing 2270 can be disposed within the left atrial appendage. In some instances, the housing 2270 can be sized to be received within or substantially within the left atrial appendage 28. For example, the sealing end 2240 can be at or distal of an ostium 29 of the left atrial appendage 28. For example, the sealing end 2240 can be at the ostium 29 of the left atrial appendage 28. Lateral wall portions 2250 of the housing 2270 can be configured to contact respective inner wall surface portions of the left atrial appendage 28. For example, one or more portions of an outer surface 2252 of the lateral wall portion 2250 can contact and / or engage with respective inner wall surface portions of the left atrial appendage 28 to facilitate secure placement of the flow-reducing device 2200. In some instances, the housing can have a width, such as a diameter, including an outer diameter, of about 0.5 centimeters (cm) to about 4 centimeters (cm), including about 0.5 centimeters (cm) to about 3 centimeters (cm), and about 1 centimeter (cm) to about 2 centimeters (cm). In some instances, a length of the housing 2270 can be about 1 centimeter (cm) to about 6 centimeters (cm), including about 1 centimeter (cm) to about 5 centimeters (cm), and about 2 centimeters (cm) to about 4 centimeters (cm). In some instances, a mounting frame can optionally be used together with the housing 2270, such as at the first end portion 2272 of the housing 2270, including at or proximate to the sealing end 2240, to facilitate secure positioning of the flowreducing device 2200. In some instances, the open end 2276 of the housing 2270 can facilitate use of the flow-reducing device 2200 with left atrial appendages of varying anatomical features, for example providing a device that is agnostic to the anatomy of the left atrial appendage.

[0145] As described herein, the piston shaft 2220 can be slidably disposed through the piston shaft opening 2248 of the sealing end 2240. At least a portion of the piston shaft 2220 disposed externally of the housing 2270 can be disposed within the left atrium 2. The damping sheet 2210 can be configured to be disposed within the left atrium 2. The damping surface 2212 of the damping sheet 2210 can be oriented toward the left atrium 2. At least a portion of the coil spring 2260 around the portion of the piston shaft 2220 disposed externally of the housing 2270 can be disposed in the left atrium 2.

[0146] The damping surface 2212 can interact with the retrograde pressure waves such that the flow-reducing device 2200 can dampen effects of the retrograde pressure waves, including retrograde V-waves, thereby preventing or reducing retrograde blood flow into the pulmonary veins. For example, retrograde pressure waves can exert a force upon the damping surface 2212 of the damping sheet 2210, pushing the piston shaft 2220 into the chamber 2278 of the housing 2270. The damping sheet 2210 can be displaced toward the sealing end 2240 of the housing 2270. The coil spring 2260 can be compressed as the damping sheet 2210 is pushed toward the sealing end 2240. As the piston shaft 2220 is translated further into the chamber 2278 of the housing 2270, the piston head 2230 can be pushed against the viscous blood. For example, a size, such as a diameter, of the second fluid opening extending through the piston head can determine at least in part the damper effect provided by the flow-reducing device. Once force exerted by the retrograde waves is removed, the coil spring 2260 can expand. For example, after removal of the force exerted by the retrograde waves, the coil spring 2260 can expand from a compressed state to a relaxed state, translating portions of the piston shaft 2220 back out of the chamber 2278 of the housing 2270. The damping sheet 2210 can be reset back to its nominal position.Additional Description of Examples

[0147] 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.

[0148] Example 1: A medical implant device can comprise an anchor configured to be positioned within a pulmonary vein, and a flow-reducing memberhaving a first end portion and a second end portion, the second end portion being coupled to the anchor, at least the second end portion of the flow-reducing member being sized to be positioned within the pulmonary vein between a left atrium and the anchor, and the flow-reducing member comprising convexly curved surface portions between the first and second end portions, the convexly curved surface portions being outwardly and laterally oriented to engage with respective inner wall portions of the pulmonary vein.

[0149] Example 2: The device of any of the examples described herein, in particular example 1, wherein the flow-reducing member is sized to allow the convexly curved surface portions to engage with respective inner wall portions of the pulmonary vein while a left atrium is in atrial systole to occlude the pulmonary vein and prevent blood flow past the flow-reducing member, and be spaced from respective inner wall portions and allow blood flow past the flow-reducing member while the left atrium is in atrial diastole.

[0150] Example 3: The device of any of the examples herein, in particular example 1, wherein the flow-reducing member is sized to allow the convexly curved surface portions to be at a first distance from inner wall portions of the pulmonary vein to allow a first blood flow rate past the flow-reducing member during atrial diastole, and be at a second distance from inner wall portions of the pulmonary vein to allow a second blood flow rate past the flow-reducing member during atrial systole, the second flow rate being less than the first flow rate.

[0151] Example 4: The device of any of the examples described herein, in particular examples 1 to 3, wherein the flow-reducing member can be sized to occlude less than about 80% of a cross section of the pulmonary vein during atrial diastole.

[0152] Example 5: The device of any of the examples described herein, in particular examples 1 to 4, wherein the flow-reducing member can comprise an incompressible member.

[0153] Example 6: The device of any of the examples described herein, in particular example 5, wherein the flow-reducing member can comprise polystyrene.

[0154] Example 7: The device of any of the examples described herein, in particular examples 1 to 4, wherein the flow-reducing member can comprise a compressible member.

[0155] Example 8: The device of any of the examples described herein, in particular example 7, wherein the flow-reducing member can comprise an inflatable balloon.

[0156] Example 9: The device of any of the examples described herein, in particular examples 1 to 8, wherein the flow-reducing member can comprise a spherical ball, the spherical ball being sized to be positioned within the pulmonary vein, and a first end portion of the anchor being oriented toward and coupled to the spherical ball, and a second end portion of the anchor oriented away from the spherical ball.

[0157] Example 10: A medical implant device can comprise an anchor sized to be positioned within a pulmonary vein, and a flow-reducing member coupled to the anchor, the flow-reducing member being sized to have at least a portion of the flow-reducing member positioned within the pulmonary vein between a left atrium and the anchor, the flow-reducing member comprising a deformable concave portion having a first surface portion forming at least a portion of a concave curvature oriented away from the anchor and a second surface portion forming at least a portion of a convex curvature oriented toward the anchor. The deformable concave portion can be configured to: assume an open state upon pressure being applied to the first surface portion during atrial systole to prevent retrograde blood flow past the flowreducing member and into the pulmonary vein, and assume a closed state upon pressure being applied to the second surface portion during atrial diastole to allow blood flow through the pulmonary vein past the reducing member and into the left atrium.

[0158] Example 11: The device of any of the examples described herein, in particular example 10, wherein the deformable concave portion can be sized to have a first end portion positioned within the left atrium and a second end portion positioned within the pulmonary vein and coupled to the anchor.

[0159] Example 12: The device of any of the examples described herein, in particular example 10 or 11, wherein the flow-reducing member can comprise flexible elongate reinforcement rods circumferentially arranged around the deformable concave portion.

[0160] Example 13: The device of any of the examples described herein, in particular examples 10 to 12, wherein the deformable concave portion can assume an umbrella canopy configuration, the deformable concave portion being sized tohave a first end portion of the umbrella canopy positioned within the left atrium and a second end portion of the umbrella canopy positioned within the pulmonary vein and coupled to the anchor.

[0161] Example 14: The device of any of the examples described herein, in particular examples 10 to 13, wherein the anchor can comprise at least one of a coil spring, a plurality of curved rods and a plurality of curved barbs.

[0162] Example 15: The device of any of the examples described herein, in particular example 14, wherein the coil spring can comprise a conical coil spring, a smaller end portion of the coil spring being coupled to the flow-reducing member and a larger end portion of the coil spring being configured to engage with the respective inner wall portions of the pulmonary vein.

[0163] Example 16: A medical implant device can comprise an anchor configured to be positioned within a pulmonary vein in fluid communication with a left atrium, and a flow-reducing member coupled to the anchor, the flow -reducing member being sized to have at least a portion of the flow-reducing member positioned within the pulmonary vein between the left atrium and the anchor, and the flowreducing member comprising a deformable funnel portion configured to be radially expandable along at least a portion thereof. The deformable funnel portion can define a first end portion having a first larger opening at a first end of the deformable funnel portion, and a second end portion having a second smaller opening at a second end of the deformable funnel portion, the second smaller opening being in fluid communication with the first larger opening via a central lumen, the first end portion having a first orientation configured to be oriented toward the left atrium and to engage with respective inner wall portions of the pulmonary vein, and the second end portion having a second opposing orientation configured to be oriented away from the left atrium and coupled to the anchor.

[0164] Example 17: The device of any of the examples described herein, in particular example 16, wherein the deformable funnel portion can comprise a deformable material and a plurality of elongate reinforcement rods coupled to the deformable material and circumferentially disposed around the deformable funnel portion.

[0165] Example 18: The device of any of the examples described herein, in particular example 16 or 17, wherein the deformable funnel portion can comprise a concave curvature along a longitudinal dimension.

[0166] Example 19: A medical implant device can comprise an anchor configured to be positioned within a pulmonary vein in fluid communication with a left atrium, and a flow-reducing member coupled to the anchor, the flow-reducing member being sized to have at least a portion of the flow-reducing member positioned within the pulmonary vein between the left atrium and the anchor, and comprising a radially expandable frame defining a central lumen extending therethrough, and the flow-reducing member can comprise a cover member configured to be oriented perpendicularly to a longitudinal axis of the radially expandable frame to occlude a first end portion of the radially expandable frame while in a closed state and to be parallel to the longitudinal axis of the radially expandable frame to allow blood to flow through the first end portion of the radially expandable frame while in an open state.

[0167] Example 20: The device of any of the examples described herein, in particular example 19, wherein the radially expandable frame can comprise an expandable stent.|0168| Example 21 : The device of any of the examples described herein, in particular example 19 or 20, wherein the cover member can comprise a leaflet and the device can comprise a hinge configured to rotatably couple the leaflet to the radially expandable frame to allow the leaflet to occlude the central lumen during atrial systole and to allow blood flow through the lumen during atrial diastole.

[0169] Example 22: The device of any of the examples described herein, in particular example 21, wherein the cover member can comprise a plurality of leaflets, and the device can comprise a respective hinge to rotatably couple each leaflet to the radially expandable frame.

[0170] Example 23: A medical implant device can comprise an inflatable flow-reducing member sized to have at least a portion of the inflatable flow-reducing member disposed within a left atrium. The inflatable flow-reducing member can be sized to have an occluding portion positioned against an inner surface portion of the left atrial wall and occlude an ostium of a pulmonary vein to prevent retrograde blood flow into the pulmonary vein during atrial systole, and spaced from the inner surface portion of the left atrial wall to allow blood from the pulmonary vein into the left atrium during atrial diastole. The device can include an anchor comprising a first portion configured to be coupled to the inflatable flow-reducing member and a secondportion configured to be coupled to an anchoring wall portion of the left atrium to secure the inflatable flow-reducing member to the anchoring portion.

[0171] Example 24: The device of any of the examples described herein, in particular example 23, wherein the occluding portion of the inflatable flowreducing member can comprise a curved surface portion.

[0172] Example 25: The device of any of the examples described herein, in particular example 24, wherein the inflatable flow-reducing member can comprise a spherical configuration.

[0173] Example 26: The device of any of the examples described herein, in particular examples 23 to 25, further comprising a second anchor comprising a first portion configured to be coupled to the inflatable flow-reducing member and a second portion configured to be coupled to a second anchoring wall portion of the left atrium for securing the inflatable flow-reducing member to the left atrial wall.

[0174] Example 27: The device of any of the examples described herein, in particular examples 23 to 26, wherein the inflatable flow-reducing member can comprise an inflation port configured to be anchored to another anchoring wall portion of the left atrium.

[0175] Example 28: The device of any of the examples described herein, in particular examples 23 to 27, further comprising a plurality of anchors, the plurality of anchors being configured to be coupled to the inflatable flow-reducing member at evenly distributed positions on the inflatable flow-reducing member.

[0176] Example 29: A medical implant device can comprise an inflatable flow-reducing member comprising a central portion defining an inner central chamber and the central portion being sized to be disposed within a left atrium, and a protrusion extending from the central portion and defining an inner protrusion chamber in fluid communication with the inner central chamber, the protrusion comprising at least a portion sized to be disposed within a pulmonary vein. The protrusion can be configured to assume an inflated state while at least a portion of the central portion is compressed by a left atrial wall during atrial systole, thereby occluding the pulmonary vein to prevent retrograde blood flow into the pulmonary vein, and assume a deflated state while the at least a portion of the central portion is spaced by the left atrial wall during atrial diastole, thereby allowing blood flow from the pulmonary vein into the left atrium.

[0177] Example 30: The device of any of the examples described herein, in particular example 29, wherein the central portion can comprise a curved surface portion configured to contact the left atrial wall while the central portion is compressed by the left atrial wall.

[0178] Example 31: The device of any of the examples described herein, in particular example 30, wherein the central portion can assume a spherical configuration.

[0179] Example 32: The device of any of the examples described herein, in particular examples 29 to 31, further comprising three protrusions extending from the central protrusion at a respective position, each of the protrusions being configured to be at least partially disposed within a respective pulmonary vein and defining an inner protrusion chamber in fluid communication with the inner central chamber. Each of the three protrusions can be configured to assume an inflated state while at least a portion of the central portion is compressed by a left atrial wall during atrial systole, thereby occluding the pulmonary vein to prevent retrograde blood flow into the respective pulmonary vein, and assume a deflated state while the at least a portion of the central portion is spaced by the left atrial wall during atrial diastole, thereby allowing blood flow from the respective pulmonary vein into the left atrium.

[0180] Example 33: A medical implant device can comprise an occlusion member sized to be positioned within a left atrium, the occlusion member comprising a surface portion configured to be positioned against a corresponding inner surface portion a left atrial wall during atrial systole to occlude an ostium of a pulmonary vein, and spaced away from the corresponding inner surface portion of the left atrial wall during atrial diastole to allow blood flow from the pulmonary vein into the left atrium. The device can include an anchor configured to be coupled to the occlusion member to the left atrial wall.

[0181] Example 34: The device of any of the examples described herein, in particular example 33, wherein the occlusion member can comprise a deformable material.

[0182] Example 35: The device of any of the examples described herein, in particular example 34, wherein the occlusion member can comprise a plurality of elongate reinforcement rods radially distributed around and coupled to the deformable material.

[0183] Example 36: The device of any of the examples described herein, in particular example 35, wherein the occlusion member can comprise an umbrella canopy configuration.

[0184] Example 37: The device any of the examples described herein, in particular examples 33 to 36, wherein the anchor can comprise a coil spring, the coil spring be configured to in a relaxed state and push the occlusion member away from the left atrial wall during atrial diastole and in a compressed state to allow the occlusion member to contact the left atrial wall during atrial systole.

[0185] Example 38: The device of any of the examples described herein, in particular example 33, wherein the occlusion member can comprise a sheet configuration.

[0186] Example 39: The device of any of the examples described herein, in particular example 38, wherein the occlusion member can be a sheet of fabric.

[0187] Example 40: The device of any of the examples described herein, in particular example 38 or 39, further comprising a plurality of anchors configured to couple the sheet to the left atrial wall.

[0188] Example 41: The device of any of the examples described herein, in particular example 40, wherein each of the plurality of anchors can comprise a suture configured to stitch the occlusion member to the left atrial wall.

[0189] Example 42: The device of any of the examples described herein, in particular examples 33 to 41, wherein the occlusion member can be configured to occlude all four pulmonary vein ostia.

[0190] Example 43: A method of implanting a medical implant de vice can comprise providing a shunt device comprising a central lumen extending from a first end opening to a second end opening, coupling the first end opening of the shunt device to a position on a first superior pulmonary vein to provide fluid communication between the central lumen and the first superior pulmonary vein, and coupling the second end opening of the shunt device to a position on a first inferior pulmonary vein to provide fluid communication between the central lumen and the first inferior pulmonary vein, thereby allowing blood flow between the first superior and inferior pulmonary veins.

[0191] Example 44: The method of any of the examples described herein, in particular example 43, wherein the first superior pulmonary vein can be a first rightsuperior pulmonary vein and the first inferior pulmonary vein can be a first right inferior pulmonary vein.

[0192] Example 45: The method of any of the examples described herein, in particular example 43 or 44, further comprising providing a second shunt device comprising a second central lumen extending from a first end opening to a second end opening, coupling the first end opening of the second shunt device to a position on a second superior pulmonary vein to provide fluid communication between the second central lumen and the second superior pulmonary vein, and coupling the second end opening of the second shunt device to a position on a second inferior pulmonary vein to provide fluid communication between the second central lumen and the second inferior pulmonary vein, thereby allowing blood flow between the second superior and inferior pulmonary veins.

[0193] Example 46: The method of any of the examples described herein, in particular example 45, wherein the second superior pulmonary vein can be a second left superior pulmonary vein and the second inferior pulmonary vein can be a second left inferior pulmonary vein.

[0194] 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).

[0195] Example 47: A medical implant device can comprise a piezoelectric material composition, and a housing configured to be disposed within a left atrium and coupled to a left atrial wall portion, and the housing comprising an internal chamber configured to receive the piezoelectric material composition, the piezoelectric material composition being configured to generate counter waves in response to detected retrograde pressure waves within the left atrium.

[0196] Example 48: The device of any of the examples described herein, in particular example 47, wherein the piezoelectric material composition can comprise a first piezoelectric material configured to transform wall motion of the left atrial wall into electricity to power the device.

[0197] Example 49: The device of any of the examples described herein, in particular example 48, wherein the housing can comprise a wall portion configured to be positioned over and in contact with the left atrial wall portion to allow the wall motion of the left atrial wall portion to deform the first piezoelectric material.

[0198] Example 50: The device of any of the examples described herein, in particular examples 47 to 49, wherein the piezoelectric material composition can comprise a second piezoelectric material configured to detect retrograde pressure waves within the left atrium.

[0199] Example 51: The device of any of the examples described herein, in particular examples 47 to 50, wherein the piezoelectric material composition can comprise a third piezoelectric material configured to generate the counter waves in response to the detected retrograde pressure waves.

[0200] Example 52: The device of any of the examples described herein, in particular examples 47 to 51, wherein the device can be configured to be coupled to a left atrial wall portion equidistant from the four pulmonary vein ostia.

[0201] Example 53: A method of implanting a medical implant device can comprise providing a first tubular reflector member, positioning the first tubular reflector member into a pulmonary vein at an insertion distance from a pulmonary vein ostium into a left atrium, analyzing retrograde wave propagation within the pulmonary vein, and adjusting the insertion distance of the first tubular reflector based at least in part on the wave analysis.

[0202] Example 54: The method of any of the examples described herein, in particular example 53, wherein adjusting the insertion distance can comprise positioning the tubular reflector member at a position to eliminate retrograde wave propagation within the pulmonary vein.

[0203] Example 55: The method of any of the examples described herein, in particular example 53 or 54, wherein analyzing the retrograde wave propagation can comprise visualizing flow patterns of blood flow in at least one of the left atrium and the pulmonary vein.

[0204] Example 56: The method of any of the examples described herein, in particular example 55, wherein analyzing the retrograde wave propagation can comprise measuring retrograde waves traveling from the left atrium into the pulmonary vein.

[0205] Example 57: The method of any of the examples described herein, in particular examples 53 to 56, wherein providing the tubular reflector member can comprise providing a cylindrical tube comprising a central lumen extending therethrough, and positioning the central lumen in alignment with a direction of blood flow in the pulmonary vein.

[0206] 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).

[0207] Example 58: A medical implant device can comprise a damping sheet configured to be disposed within a left atrium and comprising a damping surface having a first orientation and a second surface having a second opposing orientation. The device can include a piston comprising a piston head, and a piston shaft, a first end portion of the piston shaft being coupled to the second surface of the damping sheet and a second end portion of the piston shaft being coupled to the piston head, and a housing comprising a chamber configured to slidably receive the piston head and a portion of the piston shaft, at least a portion of the housing being sized to be received within a left atrial appendage, and the damping sheet disposed externally of the housing. The device can include a coil spring disposed around a portion of the piston shaft that is disposed externally of the housing.

[0208] Example 59: The device of any of the examples described herein, in particular example 58, wherein the housing is sized to have lateral wall portions of the housing in contact with respective inner wall surface portions of the left atrial appendage, and wherein the housing can comprise a first end portion having the first orientation and comprising a sealing end having a piston shaft opening configured to slidably receive a respective portion of the piston shaft, and a second end portion having the second orientation and sized to be disposed within the left atrial appendage and comprising an open end.

[0209] Example 60: The device of any of the examples described herein, in particular example 59, wherein the housing can comprise an open-ended cylinder configuration.

[0210] Example 61: The device of any of the examples described herein, in particular examples 59 or 60, wherein the sealing end of the housing can comprise a first fluid opening extending therethrough, and the piston head can comprise a second fluid opening extending therethrough, the second fluid opening having a size smaller than that of the first fluid opening.

[0211] Example 62: The device of any of the examples described herein, in particular example 61, wherein the piston head can comprise a plurality of fluid openings, a total size of the plurality of fluid openings of the piston head being smaller than that of the first fluid opening.

[0212] Example 63: The device of any of the examples described herein, in particular examples 58 to 62, wherein the coil spring can comprise a first end being configured to be in contact with the second surface of the damping sheet, and a second end being configured to be in contact with an exterior surface portion of a first end portion of the housing having the first orientation. The coil spring can be configured to assume a compressed state in response to retrograde pressure waves pushing against the damping surface and slidably displacing the piston head within the housing away from the sealing end and further into the left atrial appendage, and assume to a relaxed state in the absence of retrograde pressure waves to displace the piston head within the housing toward the sealing end and the left atrium.

[0213] Example 64: A medical implant device can comprise an anchor sized to be disposed within a pulmonary vein and to engage with inner wall portions of the pulmonary vein, and a flow-reducing member coupled to the anchor and sized to be disposed at least partially within the pulmonary vein between the anchor and a left atrium to provide a reduced a blood flow rate through the pulmonary vein past the flow-reducing member during atrial systole as compared to that during atrial diastole.

[0214] Example 65: The device of the examples described herein, in particular example 64, wherein the flow-reducing member can comprise a convexly curved surface portion with an outwardly and lateral orientation to engage with at least one of respective inner wall portions defining the pulmonary vein or pulmonary vein ostium.

[0215] Example 66: The device of any of the examples described herein, in particular example 64 or 65, wherein a widest diameter of the flow-reducing member can be sized to have the flow-reducing member occlude the pulmonary vein to prevent fluid flow past the flow-reducing member during atrial systole.

[0216] Example 67: The device of any of the examples described herein, in particular examples 64 to 66, wherein a widest diameter of the flow-reducing member can be sized to have the flow-reducing member occlude less than 80% of a cross sectional area of the pulmonary vein during atrial diastole.

[0217] Example 68: The device of the examples described herein, in particular examples 64 to 67, wherein a shape and size of the flow -reducing member can remain constant.

[0218] Example 69: The device of any of the examples described herein, in particular example 68, wherein the flow-reducing member comprises a spherical ball sized to have the spherical ball occlude the pulmonary vein during atrial systole.

[0219] Example 70: The device of any of the examples described herein, in particular examples 64 to 67, wherein the flow-reducing member can assume an expanded state having a first widest diameter sized to have the flow-reducing member occlude the pulmonary vein upon pressure exerted upon a first surface portion, and a collapsed state having a second widest diameter upon pressure exerted upon a second opposing surface portion, the second widest diameter being smaller than the first widest diameter.

[0220] Example 71: The device of any of the examples described herein, in particular example 70, wherein the flow-reducing member can comprise a deformable material forming at least a portion of a deformable concave portion, the first surface portion comprising a concave curvature of the deformable concave portion that is oriented away from the anchor and the second opposing surface portion comprising a convex curvature of the deformable concave portion that is oriented toward the anchor.

[0221] Example 72: The device of any of the examples described herein, in particular examples 64 to 71, wherein the anchor can comprise at least one of a coil spring, a plurality of curved rods and a plurality of curved barbs.

[0222] 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.

[0223] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “ .g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended 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 aresynonymous, 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.

[0224] 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.

[0225] 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.

[0226] 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 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.

[0227] 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.

[0228] 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. A medical implant device comprising: an anchor configured to be positioned within a pulmonary vein; and a flow-reducing member having a first end portion and a second end portion, the second end portion being coupled to the anchor, at least the second end portion of the flow-reducing member being sized to be positioned within the pulmonary vein between a left atrium and the anchor, the flowreducing member comprising convexly curved surface portions between the first and second end portions, the convexly curved surface portion being outwardly and laterally oriented to engage with respective inner wall portions of the pulmonary vein.

2. The device of claim 1, wherein the flow-reducing member is sized to allow the convexly curved surface portions to: engage with respective inner wall portions of the pulmonary vein while a left atrium is in atrial systole to occlude the pulmonary vein and prevent blood flow past the flow-reducing member; and be spaced from respective inner wall portions and allow blood flow past the flow-reducing member while the left atrium is in atrial diastole.

3. The device of claim 1, wherein the flow-reducing member is sized to allow the convexly curved surface portions to: be at a first distance from inner wall portions of the pulmonary vein to allow a first blood flow rate past the flow-reducing member during atrial diastole; and be at a second distance from inner wall portions of the pulmonary vein to allow a second blood flow rate past the flow-reducing member during atrial systole, the second flow rate being less than the first flow rate.

4. The device of any one of claims 1 to 3, wherein the flow-reducing member is sized to occlude less than 80% of a cross section of the pulmonary vein during atrial diastole.

5. The device of any one of claims 1 to 3, wherein the flow-reducing member comprises an incompressible member.

6. The device of any one of claims 1 to 3, wherein the flow-reducing member comprises a compressible member.

7. The device of claim 6, wherein the flow-reducing member comprises an inflatable balloon.

8. The device of any one of claims 1 to 3, wherein the flow-reducing member comprises a spherical ball, the spherical ball being sized to be positioned within the pulmonary vein, and a first end portion of the anchor being oriented toward and coupled to the spherical ball, and a second end portion of the anchor being oriented away from the spherical ball.

9. A medical implant device comprising: an anchor sized to be positioned within a pulmonary vein; and a flow-reducing member coupled to the anchor, the flow-reducing member being sized to have at least a portion of the flow-reducing member positioned within the pulmonary vein between a left atrium and the anchor, the flow-reducing member comprising a deformable concave portion having a first surface portion forming at least a portion of a concave curvature oriented away from the anchor and a second surface portion forming at least a portion of a convex curvature oriented toward the anchor, the deformable concave portion being configured to: assume an open state upon pressure being applied to the first surface portion during atrial systole to prevent retrograde blood flow past the flow-reducing member and into the pulmonary vein; and assume a closed state upon pressure being applied to the second surface portion during atrial diastole to allow blood flow through the pulmonary vein past the reducing member and into the left atrium.

10. The device of claim 9, wherein the deformable concave portion is sized to have a first end portion positioned within the left atrium and a second end portion positioned within the pulmonary vein and coupled to the anchor.

11. The device of claim 9 or 10, wherein the flow-reducing member comprises flexible elongate reinforcement rods circumferentially arranged around the deformable concave portion.

12. The device of claim 9 or 10, wherein the deformable concave portion assumes an umbrella canopy configuration, the deformable concave portion being sized to have a first end portion of the umbrella canopy positioned within the left atrium and a second end portion of the umbrella canopy positioned within the pulmonary vein and coupled to the anchor.

13. The device of claim 9 or 10, wherein the anchor comprises at least one of a coil spring, a plurality of curved rods and a plurality of curved barbs.

14. The device of claim 13, wherein the coil spring comprises a conical coil spring, a smaller end portion of the coil spring being coupled to the flow-reducing member and a larger end portion of the coil spring being configured to engage with the respective inner wall portions of the pulmonary vein.

15. A medical implant device comprising: a damping sheet configured to be disposed within a left atrium and comprising a damping surface having a first orientation and a second surface having a second opposing orientation; a piston comprising a piston head and a piston shaft, a first end portion of the piston shaft being coupled to the second surface of the damping sheet and a second end portion of the piston shaft being coupled to the piston head; a housing comprising a chamber configured to slidably receive the piston head and a portion of the piston shaft, at least a portion of the housing being sized to be received within a left atrial appendage, and the damping sheet disposed externally of the housing; and a coil spring being disposed around a portion of the piston shaft that is disposed externally of the housing.

16. The device of claim 15, wherein the housing is sized to have lateral wall portions of the housing in contact with respective inner wall surface portions of the left atrial appendage, and wherein the housing comprises: a first end portion having the first orientation and comprising a sealing end having a piston shaft opening configured to slidably receive a respective portion of the piston shaft; anda second end portion having the second orientation and sized to be disposed within the left atrial appendage, and the second end portion comprising an open end.

17. The device of claim 16, wherein the housing comprises an open-ended cylinder configuration.

18. The device of claim 16 or 17, wherein: the sealing end of the housing comprises a first fluid opening extending therethrough; and the piston head comprises a second fluid opening extending therethrough, the second fluid opening having a size smaller than that of the first fluid opening.

19. The device of claim 18, wherein the piston head comprises a plurality of fluid openings, a total size of the plurality of fluid openings of the piston head being smaller than that of the first fluid opening.

20. The device of claim 15 or 16, wherein the coil spring comprises a first end being configured to be in contact with the second surface of the damping sheet, and a second end being configured to be in contact with an exterior surface portion of a first end portion of the housing having the first orientation, the coil spring being configured to: assume a compressed state in response to retrograde pressure waves pushing against the damping surface and slidably displacing the piston head within the housing away from the sealing end and further into the left atrial appendage; and assume to a relaxed state in the absence of retrograde pressure waves to displace the piston head within the housing toward the sealing end and the left atrium.

21. A medical implant device for reducing a retrograde flow of blood through a pulmonary vein during atrial systole, comprising: an anchor sized to be disposed within a pulmonary vein and shaped to engage an inner wall of the pulmonary vein; anda flow-reducing member coupled to the anchor and sized to be disposed at least partially within the pulmonary vein between the anchor and a left atrium, wherein the flow-reducing member is adapted to impede blood flow through the pulmonary vein during atrial systole.

22. The device of claim 21, wherein the flow-reducing member comprises a convexly curved surface portion for engaging an inner wall portion along the pulmonary vein or pulmonary vein ostium.

23. The device of claim 21 or 22, wherein a diameter of the flow-reducing member is sized to prevent blood flow past the flow-reducing member during atrial systole.

24. The device of claim 21 or 22, wherein a diameter of the flow-reducing member is sized to occlude less than 80% of a cross-sectional area of the pulmonary vein during atrial diastole.

25. The device of claim 21 or 22, wherein a shape and size of the flowreducing member remains constant.

26. The device of claim 25, wherein the flow-reducing member comprises a generally spherical occluding mechanism for occluding the pulmonary vein during atrial systole.

27. The device of claim 21 or 22, wherein the flow-reducing member assumes an expanded state having a first widest diameter sized to have the flowreducing member occlude the pulmonary vein upon pressure exerted upon a first surface portion, and a collapsed state having a second widest diameter upon pressure exerted upon a second opposing surface portion, the second widest diameter being smaller than the first widest diameter.

28. The device of claim 27, wherein the flow-reducing member comprises a deformable material forming at least a portion of a deformable concave portion, the first surface portion comprising a concave curvature of the deformable concave portion that is oriented away from the anchor and the second opposing surface portioncomprising a convex curvature of the deformable concave portion that is oriented toward the anchor.

29. The device of claim 21 or 22, wherein the anchor comprises at least one of a coil spring, a plurality of curved rods and a plurality of curved barbs.

30. The device of claim 21, wherein the medical implant device treats heart failure by reducing a back-up of pulmonary pressure and lung congestion.

31. The device of claim 30, wherein blood passes around an exterior surface of the medical implant device during antegrade blood flow from the pulmonary vein into the right atrium.

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