Dual Frame Shunt

Abstract

Systems, devices, and methods are described for shunting blood from one anatomical cavity / vessel to another anatomical cavity / vessel. For example, a dual frame shunt may include an anchor frame / structure configured to self-expand and secure the shunt within an opening between two anatomical cavities / features. The shunt may also include an adjustable frame / structure disposed on the outside or inside of at least a portion of the anchor frame and configured to expand / adjust to various sizes.

Description

[Technical field]

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 318,545, filed March 10, 2022, and entitled "DUAL FRAME SHUNT," the complete disclosure of which is hereby incorporated by reference in its entirety. background Field

[0002] The present disclosure relates generally to the field of medical implantable devices. [Background technology]

[0003] 2. Description of Related Art Certain physiological parameters associated with heart chambers, such as fluid pressure, can have an impact on a patient's health outlook. In particular, high cardiac fluid pressure can lead to heart failure and / or other complications in some patients. Thus, reducing pressure in certain heart chambers through a blood flow shunt can improve a patient's health in some cases. Summary of the Invention

[0004] Described herein is one or more methods and / or devices for facilitating shunting of blood between cavities / vessels of the heart or other anatomical structures.

[0005] In embodiments, the present disclosure relates to a shunt system comprising an anchor frame disposed within an opening between a first anatomical feature and a second anatomical feature and configured to expand from a collapsed state to an expanded state, the anchor frame including a self-expanding configuration, the shunt system further comprising an adjustable frame disposed about at least a portion of the anchor frame and configured to adjust a size to set an amount of fluid flow between the first anatomical feature and the second anatomical feature.

[0006] In some examples, the anchor frame includes one or more arms that, in the expanded state, extend from a central portion of the anchor frame and are configured to secure the shunt system to a tissue wall.

[0007] In some examples, the adjustable frame includes a permanently deformable form.

[0008] In some examples, the anchor frame comprises a shape memory material.

[0009] In some examples, the adjustable frame includes at least one of stainless steel, cobalt chrome, or aluminum.

[0010] In some examples, at least one of the anchor frame or the adjustable frame includes a cover disposed between the anchor frame and the adjustable frame.

[0011] In some examples, the anchor frame and the adjustable frame are separate frame structures that are coupled together with one or more attachment mechanisms.

[0012] In some examples, the adjustable frame includes a wire frame having a substantially cylindrical configuration.

[0013] In some examples, the anchor frame includes a first anchor arm configured to contact a first tissue wall in a first anatomical feature and a second anchor arm configured to contact a second tissue wall in a second anatomical feature, the first anchor arm being angularly offset from the second anchor arm relative to a longitudinal axis of the adjustable frame.

[0014] In some examples, at least one of the first anchor arm or the second anchor arm includes a visual marker configured to provide visualization by imaging.

[0015] In embodiments, the present disclosure relates to a method of providing blood flow between a first anatomical feature and a second anatomical feature, the method including advancing a delivery catheter into an opening in a tissue wall between the first anatomical feature and the second anatomical feature, and deploying a shunt in the opening using the delivery catheter. The shunt includes an anchor frame configured to secure the shunt to the tissue wall and an adjustable frame disposed about at least a portion of the anchor frame. The anchor frame is configured with at least one of shape memory or superelastic properties. The method further includes expanding the adjustable frame to set an amount of blood flow between the first anatomical feature and the second anatomical feature.

[0016] In some examples, the method further includes determining at least one of an amount of blood flow between the first feature and the second feature or a pressure at the first anatomical feature or the second anatomical feature, and adjusting the amount of blood flow by further expanding the adjustable frame.

[0017] In some instances, deploying the shunt, expanding the adjustable frame, determining, and adjusting the amount of blood flow occur during the same medical procedure.

[0018] In some instances, the first anatomical feature is the left atrium of the heart and the second anatomical feature is at least one of the coronary sinus or the right atrium.

[0019] In some examples, the adjustable frame includes a permanently deformable form.

[0020] In some examples, the adjustable frame includes at least one of stainless steel, cobalt chrome, or aluminum.

[0021] In some examples, at least one of the anchor frame or the adjustable frame includes a cover disposed between the anchor frame and the adjustable frame.

[0022] In some examples, the anchor frame and the adjustable frame are separate frame structures that are coupled together with one or more attachment mechanisms.

[0023] In some examples, deploying the shunt includes releasing a first arm of the anchor frame to contact a first tissue wall in the first anatomical feature and releasing a second arm of the anchor frame to contact a second tissue wall in the second anatomical feature.

[0024] In an embodiment, the present disclosure relates to a shunt system including a first frame structure configured to secure the shunt system to an opening between a first anatomical feature and a second anatomical feature. The first frame structure is configured to implement a compressed configuration on a delivery system and to self-expand to an at least partially expanded configuration upon release from the delivery system. The shunt system further includes a second frame structure coupled to at least a portion of the first frame structure. The second frame structure is configured to radially expand to regulate an amount of fluid flow between the first and second features based at least in part on a radial force from an expander.

[0025] In some examples, the first framework structure includes a first anchor arm configured to contact a first tissue wall in a first anatomical feature and a second anchor arm configured to contact a second tissue wall in a second anatomical feature, the first anchor arm being angularly offset from the second anchor arm relative to a longitudinal axis of the second framework structure.

[0026] In some examples, the second framework includes a permanently deformable configuration.

[0027] In some examples, the second frame structure includes at least one of stainless steel, cobalt chrome, or aluminum.

[0028] In some examples, at least one of the first frame structure or the second frame structure includes a cover disposed between the first frame structure and the second frame structure.

[0029] In some examples, the first frame structure and the second frame structure are separate frame structures that are coupled together with one or more attachment mechanisms.

[0030] In some instances, the shunt system is sterilized.

[0031] For purposes of summarizing the disclosure, specific embodiments have been described. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0032] Various embodiments are illustrated in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the subject matter in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between referenced elements. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 illustrates the anatomy of the human heart, according to one or more embodiments. [Diagram 2] FIG. 2 shows a cross-section of a heart viewed from above with the back side facing up, in accordance with one or more embodiments. [Figure 3A] FIG. 3A shows a perspective view of a shunt in a configuration having an adjustable frame positioned about a portion of the anchor frame, according to one or more embodiments. [Figure 3B] FIG. 3B illustrates a side view of the shunt of FIG. 3A according to one or more embodiments. [Figure 3C] FIG. 3C illustrates a top view of the shunt of FIG. 3A according to one or more embodiments. [Figure 4A] FIG. 4A shows a perspective view of a shunt in a configuration having an adjustable frame positioned within a portion of the anchor frame, according to one or more embodiments. [Figure 4B] FIG. 4B illustrates a side view of the shunt of FIG. 4A according to one or more embodiments. [Figure 4C] FIG. 4C illustrates a top view of the shunt of FIG. 4A according to one or more embodiments. [Figure 5A] FIG. 5A illustrates a perspective view of an anchor frame according to one or more embodiments. [Figure 5B] FIG. 5B illustrates a side view of the anchor frame of FIG. 5A according to one or more embodiments. [Figure 5C] FIG. 5C illustrates a top view of the anchor frame of FIG. 5A according to one or more embodiments. [Figure 5D] FIG. 5D illustrates a flattened roll-out view of the anchor frame of FIG. 5A as if the anchor frame had been cut down the midline of the anchor arms according to one or more embodiments. [Figure 6A] FIG. 6A illustrates a perspective view of an adjustable frame according to one or more embodiments. [Figure 6B] FIG. 6B illustrates a side view of the adjustable frame of FIG. 6A according to one or more embodiments. [Figure 6C] FIG. 6C illustrates a top view of the adjustable frame of FIG. 6A according to one or more embodiments. [Figure 6D] FIG. 6D shows a flattened roll-out view of the adjustable frame of FIG. 6A, in which the adjustable frame appears as if it were cut down the center line of the strut pattern, according to one or more embodiments. [Figure 7-1] FIG. 7-1 illustrates a dual frame shunt including a cover disposed on an interior portion / surface of an adjustable frame according to one or more embodiments. [Figure 7-2]FIG. 7-2 illustrates a dual frame shunt including a cover disposed on an outer portion / surface of the anchor frame according to one or more embodiments. [Figure 7-3] FIG. 7-3 illustrates a dual frame shunt including a cover disposed on an outer portion / surface of an anchor frame and a cover disposed on an inner portion / surface of an adjustable frame according to one or more embodiments. [Figure 8] FIG. 8 illustrates various connection / attachment features that may be implemented to couple / attach the anchor frame to the adjustable frame in accordance with one or more embodiments. [Figure 9-1] 1 shows a flow chart illustrating a process for implanting a shunt in accordance with one or more embodiments. [Figure 9-2] 1 shows a flow chart illustrating a process for implanting a shunt in accordance with one or more embodiments. [Figure 9-3] 1 shows a flow chart illustrating a process for implanting a shunt in accordance with one or more embodiments. [Figure 9-4] 1 shows a flow chart illustrating a process for implanting a shunt in accordance with one or more embodiments. [Figure 9-5] 1 shows a flow chart illustrating a process for implanting a shunt in accordance with one or more embodiments. [Figure 10-1] 9-1 through 9-5 show images of cardiac anatomy and certain devices / systems corresponding to operations of the processes of FIGS. 9-1 through 9-5, according to one or more embodiments. [Figure 10-2] 9-1 through 9-5 show images of cardiac anatomy and certain devices / systems corresponding to operations of the processes of FIGS. 9-1 through 9-5, according to one or more embodiments. [Figure 10-3] 9-1 through 9-5 show images of cardiac anatomy and certain devices / systems corresponding to operations of the processes of FIGS. 9-1 through 9-5, according to one or more embodiments. [Figure 10-4] 9-1 through 9-5 show images of cardiac anatomy and certain devices / systems corresponding to operations of the processes of FIGS. 9-1 through 9-5, according to one or more embodiments. [Figure 10-5]9-1 through 9-5 show images of cardiac anatomy and certain devices / systems corresponding to operations of the processes of FIGS. 9-1 through 9-5, according to one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the subject matter.

[0035] Although specific examples are disclosed below, the subject matter extends beyond the specifically disclosed examples to other alternative examples and / or applications, as well as modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific examples described herein. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order, and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding a particular example, the order of description should not be construed as implying that these operations are order dependent. In addition, 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 all such aspects or advantages are necessarily achieved by any particular example. Thus, for example, the various examples may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0036] Certain reference numbers are reused across different figures throughout the figures of this disclosure for convenience with respect to devices, components, systems, features, and / or modules having characteristics that may be similar in one or more respects. However, with respect to any of the examples disclosed herein, the reuse of a common reference number in a figure does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one skilled in the art can learn from the context as to the extent to which the use of a common reference number may suggest similarity between the referenced objects. The use of a particular reference number in the context of a description of a particular figure can be understood as relating to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified with the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number can be interpreted as sharing features or as being entirely independent of each other.

[0037] Certain standard terms of location are used herein to refer to certain device components / features and, for some embodiments, animal, i.e., human, anatomical structures. While certain spatially relative terms, such as "outer," "inner," "upper," "lower," "lower," "upper," "vertical," "horizontal," "top," "bottom," "lower," "upper," "upper side," "lower" and similar terms, are used herein to describe the 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 relationships between the elements / structures illustrated in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the elements / structures in use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or to the side of such other element / structure with respect to alternative orientations of the subject patient or element / structure, and vice versa.

[0038] The term "associated with" is used herein in accordance with its broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description may be generally understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, at least partially embedded within, or otherwise physically associated with, whether directly or indirectly, the second feature, element, component, device, or member.

[0039] Certain examples of shunt implantation devices are disclosed herein in the context of cardiac implantation devices and cardiac physiology, which are discussed in detail below to provide a context to aid in the consideration of aspects of the devices disclosed herein, however, although certain principles disclosed herein are particularly applicable to cardiac anatomical structures, a shunt implantation device according to the present disclosure may be implanted or configured to be implanted in any suitable or desired anatomical structure. Cardiac Physiology

[0040] The anatomy of the heart is described below to aid in understanding certain features disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, and flow between its associated cavities and vessels is controlled, at least in part, by various cardiac valves, namely, the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves may be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., relaxation and systole) to at least in part control the flow of blood to respective regions and / or vessels of the heart (e.g., the pulmonary artery, the aorta, etc.).

[0041] 1 and 2 respectively illustrate vertical / frontal and horizontal / superior cross-sectional views of an exemplary heart 102 with various functional / anatomical structures relevant to certain aspects of the disclosure. The heart 102 includes four chambers: left atrium 104, left ventricle 106, right ventricle 108, and right atrium 110. In terms of blood flow, generally, blood flows from the right ventricle 108 to the pulmonary artery 112 via the pulmonary valve 114, which separates the right ventricle 108 from the pulmonary artery 112 and is configured to open during systole so that blood may be pumped towards the lungs and close during diastole to prevent blood from flowing back from the pulmonary artery 112 into the heart. The pulmonary artery 112 carries deoxygenated blood from the right side of the heart to the lungs.

[0042] In addition to the pulmonary valve 114, the heart 102 includes three additional valves to aid in blood circulation therein, including a tricuspid valve 116, an aortic valve 118, and a mitral valve 120. The tricuspid valve 116 separates the right atrium 110 from the right ventricle 108. The tricuspid valve 116 typically has three cusps or leaflets and typically can close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 120 typically has two cusps / leaflets and separates the left atrium 104 from the left ventricle 106. The mitral valve 120 is configured to open during diastole to allow blood from the left atrium 104 to flow into the left ventricle 106, and when functioning properly, closes during systole to prevent blood from flowing back into the left atrium 104. The aortic valve 118 separates the left ventricle 106 from the aorta 122. The aortic valve 118 is configured to open during systole to allow blood exiting the left ventricle 106 to enter the aorta 122, and to close during diastole to prevent blood from flowing back into the left ventricle 106.

[0043] A heart valve may generally include a relatively dense fibrous ring, referred to herein as the annulus, and multiple leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that when the heart contracts, the increased blood pressure generated within the corresponding heart chamber causes the leaflets to at least partially open, thereby allowing flow from the heart chamber. When pressure within a heart chamber decreases, pressure within the subsequent heart chamber or blood vessel may prevail and push the leaflets back. As a result, the leaflets / cusps appose each other, thereby closing the flow path. Dysfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) may result in valve leakage and / or other health complications.

[0044] Atrioventricular (i.e., mitral and tricuspid) heart valves may further include a collection of chordae tendineae and papillary muscles (not shown) that anchor the leaflets of each valve to promote and / or facilitate proper coaptation of the leaflets and prevent their prolapse. For example, the papillary muscles may generally include finger-like projections from the ventricular wall. The leaflets of the valve are connected to the papillary muscles by the chordae tendineae.

[0045] A muscular wall called the septum separates the left heart chamber from the right heart chamber. In particular, an interatrial septal wall portion 124 (also referred to herein as the "atrial septum," "atrial septum," or "septum") separates the left atrium 104 from the right atrium 110, while an interventricular septal wall portion 126 (also referred to herein as the "ventricular septum," "interventricular septum," or "septum") separates the left ventricle 106 from the right ventricle 108. The inferior tip 128 of the heart 102, referred to as the apex, is generally located in the fifth intercostal space, at or near the clavicular midline.

[0046] The coronary sinus 130 includes a collection of veins that combine to form a relatively large vessel that collects blood from the cardiac muscle (myocardium). The ostium 202 (see FIG. 2 ) of the coronary sinus 130, which may be at least partially protected by the Thebesian valve in some patients, opens into the right atrium 110 as shown. The coronary sinus 130 extends along the posterior aspect of the left atrium 104 and supplies less oxygenated blood to the right atrium 110. The coronary sinus 130 generally extends laterally within the left atrioventricular groove located on the posterior side of the heart.

[0047] As referenced above, certain physiological conditions or parameters associated with the anatomy of the heart can affect the health of a patient. For example, congestive heart failure is a disease associated with the relatively slow movement of blood through the heart and / or body that causes an increase in fluid pressure within one or more chambers of the heart. As a result, the heart does not pump enough oxygen as the body requires. The various chambers of the heart may respond to the increased pressure by stretching to hold more blood and pump it through the body, or by becoming relatively stiffer and / or thicker. Over time, the walls of the heart may weaken and may not be able to pump as efficiently. In some cases, the kidneys may respond to the heart's failure and retain fluid within the body. Fluid may accumulate in the arms, legs, ankles, feet, lungs, and / or other organs, causing the body to become congested, hence the term congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and mortality and therefore, treatment and / or prevention of congestive heart failure is of significant medical concern.

[0048] Treatment and / or prevention of heart failure (e.g., congestive heart failure) can include shunting some amount of fluid from a problematic high pressure cavity / vessel to a lower pressure cavity / vessel. For example, to address elevated left atrial pressure, a shunt can be implanted / formed in the interatrial septal wall or in the wall separating the left atrium from the coronary sinus to relieve pressure on the relatively lower pressure right atrium or coronary sinus. Shunting can be accomplished using an implanted shunt structure (e.g., a stent, etc.) or simply through the formation of an opening / aperture in the septal wall. However, many shunt solutions are configured to allow a fixed amount of blood flow, which can result in too little or too much blood flow between the cavities / vessels. Furthermore, the amount of shunting may not be precisely known prior to the procedure, so it may be necessary to replace the shunt or find another solution if the shunt does not address the heart problem.

[0049] Dual Frame Shunt The present disclosure relates to systems, devices, and methods for shunting blood from, for example, a cardiac cavity / vessel to a relatively low pressure cavity / vessel using a dual frame shunt. The dual frame shunt may include two frame structures with different expansion / elasticity / deformation characteristics to facilitate adjustment of the amount of fluid flowing from one anatomical cavity / feature to another. The shunt may include an anchor frame / structure that includes self-expanding characteristics and is configured to secure the shunt within an opening between two anatomical cavities / features. The shunt may also include an adjustable frame / structure disposed on the outside or inside of at least a portion of the anchor frame and configured to expand / adjust to various sizes. In some examples, the shunt may be delivered to a target site using a delivery catheter or another device / system for a minimally invasive procedure. The shunt may be compressed and coupled to a delivery catheter. The shunt may be released from the delivery catheter at the target site and the anchor frame may at least partially self-expand to secure the shunt in the opening between the two anatomical cavities / features. The adjustable frame may be configured to couple / contact the anchor frame and control the amount of blood flowing between anatomical cavities / features. For example, an expansion device may be used to set / adjust the size of the blood flow passageway through the shunt. This may meet different blood flow needs to more effectively address cardiac or other issues (e.g., allowing different amounts of pressure to be released from one cavity to another).

[0050] In many examples, the systems, devices, and methods are discussed in the context of shunting blood from the left side of the heart (e.g., left atrium) to the relatively lower pressure right ventricle (e.g., right atrium, coronary sinus). Such shunting may be considered a left-to-right shunt in that it involves shunting blood from a left-side chamber / vessel to a right-side chamber / vessel, which may be advantageous due to the higher fluid pressure typically experienced on the left side (e.g., oxygenated side) of the blood circulation during at least a portion of the cardiac cycle. However, the systems, devices, and methods may be implemented in other contexts, such as right-to-left shunting, other cardiac features, other types of fluids / gases, and / or other anatomical features.

[0051] 3A-3C and 4A-4C show diagrams of an exemplary dual frame shunt device / system 300 (also referred to as "shunt 300") including an anchor frame / structure / component 310 (also referred to as "self-expanding frame 310") configured to secure the shunt 300 to a desired anatomical structure and an adjustable frame / structure / component 320 configured to set / adjust the volume of the shunt. Figures 3A-3C show the adjustable frame 320 positioned / disposed on the outside of the anchor frame 310 (also referred to as the "external configuration"), while Figures 4A-4C show the adjustable frame 320 positioned / disposed on the inside of the anchor frame 310 (also referred to as the "internal configuration"). Figures 3A and 4A show a perspective view of the shunt 300, Figures 3B and 4B show a side view of the shunt 300, and Figures 3C and 4C show a plan view of the central flow tube / lumen 302 formed by the barrel 304 (also referred to as "barrel structure 30#") of the shunt 300 along the axis A1 of the barrel 304. For ease of illustration, to distinguish the anchor frame 310 from the adjustable frame 320, the adjustable frame 320 may be shown in stippled form in the figures.

[0052] 3A-3C and 4A-4C show the shunt 300 in at least a partially expanded configuration / configuration, such as when positioned / deployed within an opening between two anatomical features (e.g., cavities, vessels, etc.). When expanded, the barrel 304 and central flow lumen 302 of the shunt 300 can define a generally circular or elliptical opening for fluid passage, as seen from above in FIGS. 3C and 4C, with the barrel 304 configured to hold open a side of a puncture / hole in a tissue wall and form a blood flow pathway between cavities / vessels on opposing sides of the tissue wall. The barrel 304 of the shunt 300 can refer to structures (e.g., walls, struts, wires, etc.) of the anchor frame 310 and / or adjustable frame 320. In the external configuration (FIGS. 3A-3C), the barrel 304(A) of the anchor frame 310 generally forms the blood flow pathway (e.g., closest to the blood flow), while the barrel 304(B) of the adjustable frame 320 contacts the tissue within the opening. While in the internal configuration (FIGS. 4A-4C), the barrel 304(B) of the adjustable frame 320 generally forms the blood flow pathway and the barrel 304(A) of the anchor frame 310 contacts the tissue within the opening. However, portions of the anchor frame 310 and / or adjustable frame 320 in either configuration may at least partially contact tissue and / or form a blood flow pathway. In either configuration, the adjustable frame 320 and the anchor frame 310 may be coupled or contacted to one another such that the barrel 304(A) of the anchor frame 310 is generally constrained / restricted by the adjustable frame 320, allowing the amount of blood flow to be controlled / adjusted by the size of the adjustable frame 320, as discussed in more detail below.

[0053] The anchor frame 310 may include a number of anchor arms 312(A)-312(D) (also referred to as "anchor arms 312") radiating from the end of the barrel 304. The anchor arms 312 may be of any length and may have tissue contact pads / feet 314(A)-314(D) associated with their distal ends, such pads / feet 314 configured to contact the surface of a tissue wall into which the shunt 300 is implanted. The illustrated embodiment includes tissue circular / eyelet type contact pads / feet 314, although tissue contact pads / feet of other shapes may be implemented in conjunction with embodiments of the present disclosure. The pads / feet 314 may provide a relatively wide / spread area relative to the relatively narrow elongated strut / arm portion 312, which may distribute the contact force / pressure exerted by the shunt 300 on the biological tissue wall / surface over a relatively wide area.

[0054] In the illustrated embodiment, the lower anchor arms 312(C) and 312(D) each include an additional eyelet 316 that may be attached to a suture / extension member to assist in controlling the anchor arms 312(C), 312(D) during deployment. For example, a suture may extend from the proximal end of the delivery system and be pulled / pushed / controlled by the physician / user to collapse the anchor arms 312(C), 312(D) and / or slowly release the anchor arms 312(C), 312(D) (which in some instances may be initially deployed at the target site).

[0055] The set of anchoring arms 312 may have shape memory configured to curl outward from the barrel 304 and / or axis A1 (e.g., longitudinal axis) when deployed and / or expanded. Portions of such arms / anchoring means may project approximately radially away from the imaginary reference axis A1 in the expanded configuration shown. Although four anchoring arms are shown, any number of arms may be implemented. In an embodiment, the upper arm 312(A) is vertically offset (e.g., relative to the vertical axis A1) from the anchoring arm 312(B) as shown in Figures 3A / 4A and 4B / 4B. However, the upper arm 312(A) may not be offset and / or any of the other arms may be vertically offset.

[0056] As discussed above, the adjustable frame 320 may be configured / designed to be disposed around or within the barrel 304(A) of the anchor frame 310 and configured to control the size / diameter of the blood flow path through the shunt 300. For example, the adjustable frame 320 may be coupled to, contact / press against, or be integral with the anchor frame 310 to constrain / limit the anchor frame 310 from radial expansion. The adjustable frame 320 may generally be configured to adjust the size / diameter when an external force above a threshold is applied to the adjustable frame 320, such as by an expansion device. To constrain / limit the anchor frame 310, the adjustable frame 320 and anchor frame 310 may generally be designed such that the radial / expansion force applied by the anchor frame 310 (applied to self-expand to a fully expanded configuration) is less than the threshold force required to adjust the size / diameter of the adjustable frame 320.

[0057] To illustrate, in an external configuration (as shown in FIGS. 3A-3C), the adjustable frame 320 can prevent the barrel 304(A) of the anchor frame 310 from expanding beyond an inner diameter D1 of the adjustable frame 320 (as best shown in FIG. 3C) because the adjustable frame 320 surrounds the barrel 304(A) of the anchor frame 310. Additionally, in an internal configuration (as shown in FIGS. 4A-4C), the adjustable frame 320 can be coupled to the barrel 304(A) of the anchor frame 310 to prevent the anchor frame 310 from expanding beyond the constraints imposed by being attached / coupled to the anchor frame 310. In either configuration, the size / diameter of the adjustable frame 320 (e.g., D1) is generally adjusted by an expansion device inserted into the lumen of the barrel 304 and configured to apply a radially outward force.

[0058] The anchor frame 310 and the adjustable frame 320 may include different features to provide various functions to the shunt 300. For example, the anchor frame 310 may be more elastic (less deformable than the adjustable frame 320) than the adjustable frame 320, thereby allowing the anchor frame 310 to be delivered to the target site in a compressed / folded state and released to a predetermined shape, while the adjustable frame 320 may be more easily deformed and maintain a relatively more permanent shape. In some examples, the anchor frame 310 is formed from Nitinol or another shape memory / superelastic metal that can be compressed / deformed when an external force is applied and return to a pre-compressed / deformed state when the external force is removed. Additionally, the adjustable frame 320 may be formed from stainless steel, cobalt chrome, aluminum, or another material that can be compressed / deformed when an external force is applied and maintain a compressed / deformed shape when the external force is removed. In an embodiment, the anchor frame 310 has a higher elasticity than the adjustable frame 320 (e.g., the anchor frame 310 includes superelastic properties).

[0059] 3A, openings / spacing between the strut patterns of adjustable frame 320 may provide locations for anchor arms 312 to extend through. In an example, anchor arms 312(A) may extend between adjacent strut components (e.g., strut patterns / structures) of adjustable frame 320, which may provide a tighter fit for frames 310 and 320. In some examples (not shown), anchor arms 312 may extend through a central opening in the strut patterns / structures.

[0060] Although various embodiments illustrate adjustable frame 320 as a separate component / element from anchor frame 310, adjustable frame 320 may be integrated with anchor frame 310. For example, anchor frame 310 and adjustable frame 320 may be implemented as a continuous / connected frame structure with different characteristics to implement the described functionality of each frame.

[0061] 5A-5D show various views of anchor frame 310 illustrating details of an embodiment of anchor frame 310. Fig. 5A shows a perspective view of anchor frame 310, Fig. 5B shows a side view of anchor frame 310, Fig. 5C shows a top axial view through the central flow tube / lumen # of anchor frame 310, and Fig. 5D shows a flattened rolled-out view of anchor frame 310 as if anchor frame 310 were cut down the midline of anchor arm 312(A).

[0062] The anchor frame 310 and / or its barrel portion / structure 304(A) may be defined at least in part by an arrangement of relatively thin struts / elements that form an array of cells / openings. For example, some or all of the anchor frame 310 may be formed by superelastic struts that can be compressed into a delivery catheter and then expanded back to a relaxed shape. Formation of the anchor frame 310 with multiple interconnected strut forming cells therebetween may provide the desired flexibility of the anchor frame 310, which allows for compression and subsequent expansion at the implantation site. The struts may be arranged in an interconnected pattern that omits any sharp corners or points that may snag tissue as the shunt 300 is manipulated / advanced through / within the puncture. The sidewalls of the barrel 304(A) together may define a tubular lattice that forms channels through which blood flow passes through the shunt 300 when implanted. In an embodiment, the anchor frame 310 may be formed of a stent / stent-like wireframe structure. In the embodiment shown in Figures 5A-5D, the barrel 304(A) includes a connection point / eyelet 502 that can be used to connect the anchor frame 310 to the adjustable frame 320 and / or for a visual marker feature, as discussed herein.

[0063] Barrel 304(A) may be configured to be radially crimped to a collapsed or crimped state for introduction into the body on / in a delivery catheter and radially expandable to an expanded state for implanting anchor frame 310 in a desired location in the body (e.g., the atrial septum or wall separating the coronary sinus from the left atrium, etc.). Anchor frame 310 may be made of a plastically expandable material that allows for crimping of its struts to a smaller profile for delivery and expansion, which may generally be accomplished by self-expansion caused by shape memory / elastic properties (although an expansion / dilation device such as a balloon of a balloon catheter may also be used). For example, utilizing self-expanding struts / structures, anchor frame 310 may be crimped to a smaller profile and held in the crimped state with a restraining device such as a sheath that covers the compressed anchor frame 310. When the anchor frame 310 is positioned at or near the target site, the restraining device can be removed to release the anchor frame 310 and allow the anchor frame 310 to self-expand to its expanded state. In the implanted state, the axis A1 of the barrel 304(A) may be perpendicular or angled relative to a line / plane perpendicular to the tissue wall surface.

[0064] The anchor arms 312 of the anchor frame 310 may be angularly distributed about the axis A1 of the shunt 300 and / or the barrel 304 in any suitable or desirable manner. For example, as best illustrated in the axial view of FIG. 5C, the upper arms 312(A) and 312(B) may be angularly distributed in some manner about the circumference / perimeter of the barrel 304(A), such that in an expanded configuration, the upper arms 312(A) and 312(B) project away from the barrel 304(A) and / or the axis A1 and are angularly offset 180 degrees from one another, as indicated by angle θ1. Additionally, the lower arms 312(C) and 312(D) may be angularly offset from one another by different amounts, as indicated by angle θ2, and / or may be angularly offset from either of the upper arms 312(A) and 312(B), as indicated by angle θ3. For example, such angular offset between the arms may serve to secure the anchor frame 310 to the tissue wall in which it is to be implanted in a manner that resists tilting, rotation, or other dislodging, movement, and / or undesired movement of the shunt 100 from a desired implantation location and / or orientation after implantation. For example, the pressure contact points associated with the feet / pads 314 of the upper arms 312(A) and 312(B) distal to the tissue wall in which the implant is to be placed may be angularly offset from the tissue contact pressure points / areas associated with the feet / pads 314 of the lower arms 312(C) and 312(D), thereby distributing the contact pressure over a larger area of ​​the tissue wall in which the implant is to be placed. In embodiments, the arms 312 / feet / pads 314 may be covered with a sleeve / sock / covering (not shown). Although various angular offsets of the anchor arms 312 are illustrated in the figures, the arms 30312 may be offset / positioned by other amounts.

[0065] In an embodiment, one or more of the contact pads 314 and / or eyelets 502 may be associated with a particular visual marker feature configured to provide visualization (e.g., enhanced visibility through imaging), such as ultrasound, x-ray, or other imaging modalities. For example, the contact pads 314 and / or eyelets 502 (and / or other features of the anchor frame 310 and / or adjustable frame 320) may include a particular visual marker band, stud, or the like, which includes echogenic or other imaging enhancing properties (e.g., radiopaque material). In an embodiment, the contact pads / eyelets may include an echogenic material, such as a metal (e.g., tantalum) or other material configured to be relatively distinguishable / visible under the imaging mechanism. The illustrated circular form of the various contact pads / eyelets associated with the respective anchor arms may facilitate a process for implementing the visual marker bands / studs therein, such as through a coining process or similar process. For example, the marker may be press-fit and / or melted / formed into the central opening / aperture of the contact pad / eyelet. Enhanced visualization mechanisms can aid in intraoperative placement of the shunt 300 in the target anatomical structure.

[0066] Figures 6A-6D show various views of adjustable frame 320 and detail an embodiment thereof. Figure 6A shows a perspective view of adjustable frame 320, Figure 6B shows a side view of adjustable frame 320, Figure 6C shows a top down axial view through the central flow tube / lumen of adjustable frame 320, and Figure 6D shows a flattened rolled out view of adjustable frame 320 as if adjustable frame 320 were cut down the centerline of the strut pattern.

[0067] The adjustable frame 320 and / or its barrel portion / structure 304(B) may be defined at least in part by an arrangement of relatively thin struts / elements forming an array of cells / openings. Formation of the adjustable frame 320 using a plurality of interconnected struts forming cells therebetween may provide the desired expansion of the adjustable frame 320. The struts may be arranged in an interconnected pattern that omits any sharp corners or points that may snag tissue as the shunt 300 is manipulated / advanced through / within the puncture. In the embodiment shown in FIGS. 6A-6D, the struts form a diamond-shaped pattern, although other shapes / patterns such as a chevron pattern, a wishbone pattern, a crown-shaped pattern, etc. may be implemented. The side walls of the barrel 304(B) together may define a tubular lattice that forms channels through which blood flow passes through the expandable frame 320 when implanted and / or to retain tissue walls within the puncture. For example, the interconnected struts around the barrel 304(B) can provide a cage-type structure that provides sufficient stability / integrity to hold the tissue open at the puncture site. In an embodiment, the adjustable frame 320 can be formed of a stent / stent-like wire frame structure. In the embodiment shown in Figures 6A-6D, the barrel 304(B) includes connection points / eyelets 602 (e.g., at the top of the page, as compared to Figure 6D) that can be used to connect the adjustable frame 320 to the anchor frame 310 and / or for visual marker features. The adjustable frame 320 / barrel 304(B) can include a structure (e.g., a wire frame) having a substantially cylindrical form. The length of the adjustable frame 320 / barrel 304(B) L1 (as seen in Figure 6B) can be designed to fit / align with the anchor frame 310.

[0068] The barrel 304(B) of the adjustable frame 320 may be configured to be radially expanded by an expansion / dilation device at the implantation site (e.g., expanded based on a radial force from an expander). In an embodiment, the barrel 304(B) is formed of a material configured to be more permanently deformed / expanded as compared to the anchor frame 310. For example, the adjustable frame 320 may be formed of stainless steel, cobalt chrome, aluminum, or another material (e.g., a deformable metal) that allows the adjustable frame 320 to expand (when an external force is presented) and maintains the expanded / deformed shape when the external force is removed. In an embodiment, the adjustable frame 320 is permanently deformable such that the adjustable frame 320 is not configured to be compressed (at least without suffering structural damage to its shape / form) after the adjustable frame 320 is expanded. To illustrate, the adjustable frame 320 may be configured to have an initial state in which the inner diameter D1 has an initial value, as shown in FIG. 6C, where the adjustable frame 320 is loaded onto a delivery device (e.g., coupled to a compressed anchor frame 310). Upon release from the delivery device at a target site, the arms 312 of the anchor frame 310 can self-expand. An expansion device can then be used to expand the adjustable frame 320 (e.g., increase the diameter D1) and also expand the barrel 304 (B) of the anchor frame 310. When the force from the expansion device is removed, the adjustable frame 320 can maintain the same increased diameter D1. In some embodiments, the adjustable frame 320 is not configured to self-expand (e.g., configured to expand only when an external force is applied).

[0069] In some embodiments, one or more components of the shunt 300 may be covered / attached with a cover / coating 702, as shown in FIGS. 7-1-7-3, which may be implemented to prevent corrosion and / or undesirable deformation due to the frame components directly contacting and / or rubbing against each other. For example, the anchor frame 310 and the adjustable frame 320 may contact each other in one or more locations (which may cause the components to rub against each other when implanted in a patient). This may cause corrosion (e.g., galvanic corrosion) or other undesirable problems of the frame components. To prevent such problems, the cover 702 may be disposed between or attached to the anchor frame 310 and / or the adjustable frame 320. The cover 702 may include fabric (e.g., polyethylene terephthalate (PET), woven fabric, etc.), polymer / plastic (e.g., polyurethane), and / or any other material to provide a barrier / protection to the frame components. The cover 702 may be attached to one or more components of the shunt 300 in a variety of ways, such as via adhesives, fasteners, heat treatments (eg, shrink wrap), and the like.

[0070] In one embodiment, as shown in FIG. 7-1, the cover 702 is disposed on an interior portion / surface of the adjustable frame 320, such as within the barrel 304(B) of the adjustable frame 320, to prevent the anchor frame 310 from directly contacting the adjustable frame 320. In another embodiment, as shown in FIG. 7-2, the cover 702 is disposed on an exterior portion / surface of the anchor frame 310. In a further embodiment, as shown in FIG. 7-3, a first cover 702(A) is disposed on the anchor frame 310 (e.g., on the exterior surface) and a second cover 702(B) is disposed on the adjustable frame 320 (e.g., on the interior surface). In yet another embodiment, the cover 702 may be implemented as a separate element that is positioned between the anchor frame 310 and the adjustable frame 320 and held in place by the frames being pressed together (without being attached to any frame structure).

[0071] 7-1-7-3 show the cover 702 positioned on the shunt 300 in an external configuration (where the adjustable frame 320 is positioned outside of the anchor frame 310), the cover 702 may be similarly implemented for an internal configuration (where the adjustable frame 320 is positioned within the anchor frame 310). In an internal configuration, the cover 702 may be similarly positioned / located to prevent the anchor frame 310 from directly contacting the adjustable frame 320. Additionally, in some instances, the cover 702 is positioned just where the anchor frame 310 would contact the adjustable frame 320.

[0072] As mentioned above, in an embodiment, the anchor frame 310 and the adjustable frame 320 are separate elements that are coupled / attached together. FIG. 8 illustrates various connection / attachment features 802(1)-801(N), where N represents an integer, that may be implemented at various connection / attachment points 804 to couple / attach the anchor frame 310 to the adjustable frame 320. Each connection point 804 may represent a location / point where the frame 310 and the frame 320 are in contact and connected to each other, or where the frame 310 and the frame 320 are otherwise connected, such as when there is a gap between the frame 310 and the frame 320. A connection point 804(A) represents any of the connection points 804. The connection / attachment features 802 may include a variety of features, such as sutures 802(1), detents and cavities / receiving members 802(2), pins and holes / cavities 802(3), fasteners 802(4), adhesives, crimp members / joints, welds (e.g., weld members / joints), solder, etc. For ease of illustration, only a few connection points 804 are shown; that is, other connection points may additionally or alternatively be implemented at various locations on the structure of the anchor frame 310 and / or adjustable frame 320.

[0073] In some embodiments, one or more of the eyelets 502 of the anchor frame 310 and / or the eyelets 602 of the adjustable frame 320 may be coupled together using any of the connection / attachment features 802, as shown in callout 806. Although the eyelets 502 and 602 are not aligned in the view of FIG. 8 (or elsewhere), the anchor frame 310 and the adjustable frame 320 may be positioned and / or the eyelets 502 and 602 may be designed such that the eyelets 502 and 602 are aligned (e.g., concentric), which may facilitate attachment / connection. However, the anchor frame 310 and the adjustable frame 320 do not need to be aligned to facilitate attachment through the connection / attachment features 802. Additionally, while FIG. 8 shows the shunt 300 in an external configuration, similar features 802 may be implemented for an internal configuration.

[0074] 9-1-9-5 provide a flow diagram illustrating a process 900 for implanting a shunt device, according to one or more embodiments. FIGS. 10-1, 10-1-10-5 provide images of cardiac anatomy and specific devices / systems corresponding to the operations of process 900 of FIGS. 9-1-9-5, according to one or more embodiments. One or more of the acts / operations of process 900 may be performed in the same medical procedure, separate medical procedures, or at other times.

[0075] At block 902, the process 900 includes providing a delivery system / device 1002 with the shunt implant 300 disposed therein in a delivery configuration. Image 1004 of FIG. 10-1 illustrates a partial cross-sectional view of a delivery / placement system 1002 for a shunt implant device 300, according to one or more embodiments of the present disclosure. Although specific embodiments of a delivery system are illustrated in the various figures, shunt implant devices according to embodiments of the present disclosure may be delivered and / or implanted using any suitable or desired delivery system and / or delivery system components.

[0076] The illustrated delivery system 1002 includes an inner catheter / shaft / sheath 1006, which may be at least partially disposed within an outer catheter / shaft / sheath 1008. In some embodiments, the shunt implantation device 300 may be at least partially disposed around the inner catheter 1006 and at least partially within the outer sheath 1008. For example, the inner catheter 1006 may be disposed within a barrel portion 304 of the shunt implant 300. In some embodiments, the shunt implant 300 may be disposed around a shunt holder portion / component, which may be integral with the inner catheter / shaft 1006 or may be a separate component of the system 1002 that is attached or otherwise coupled in some manner to the inner catheter / shaft 1006. In some embodiments, the shunt holder includes one or more cutouts, depressions, recesses, channels, gaps, openings, apertures, holes, slits, or other features configured to accommodate the presence of the shunt implant 300 and / or other features or aspects of the shunt implant 300.

[0077] In the compressed delivery configuration shown in image 1004, the shunt implant 300 may have a generally tubular form. The anchor frame 310 may be generally compressed to fit within the outer sheath 1008, while the adjustable frame 320 may slide over the anchor frame 310 / inner shaft 1006 in an initial, unexpanded configuration. In such a configuration, the anchor features / arms 312 may form an extension of the barrel wall in the tubular form. For example, the tubular shape may correspond to a more crimped configuration of the shape that the shunt 300 (e.g., anchor frame 310) may have immediately after being laser cut from a tubular workpiece. During manufacturing, the uncrimped tubular form of the anchor frame 310 may be deformed, such as using a mandrel, to bend the anchor features / arms radially outward, for example, into an expanded configuration. The anchor frame 310 in its deformed shape can then be heat treated so that the memory metal (e.g., Nitinol) material reaches a transition temperature and the expanded shape becomes the relaxed / programmed shape of the anchor frame 310. The memory metal shunt can then be bent and crimped into a tubular shape to reduce the tubular diameter for loading into the delivery catheter 1002.

[0078] In some embodiments, the delivery system 1002 may be configured such that a guidewire 1010 may be at least partially disposed therein. For example, the guidewire 1010 may run within a region of the shaft of the outer sheath 1008 and / or the inner catheter 1006, as shown. The delivery system 1002 may be configured to be advanced over the guidewire 1010 to guide the delivery system 1002 to the target implantation site.

[0079] In some examples, the delivery system 1002 includes a tapered nose cone feature 1012 that may be associated with the distal end of the delivery system 1002 as shown. In some implementations, the nose cone feature 1012 may be utilized to enlarge an opening in a tissue wall into which the shunt implant 300 is embedded or through which the delivery system 1002 is advanced. The nose cone feature 1012 may facilitate advancement of the distal end of the delivery system 1002 through a tortuous anatomy of a patient and / or with an outer delivery sheath or other conduit / pathway. The nose cone 1012 may be a separate component from the catheter / inner shaft 1006 or may be integrated with the catheter 1006. In some examples, the nose cone 1012 is adjacent to and / or integrated with the distal end of the outer sheath 1008. In some embodiments, the nose cone 1012 may include and / or be formed from multiple flap-type formations that are urged / spread apart as the shunt implant 300 and / or any portion thereof, the inner catheter 1006, or other device is advanced therethrough.

[0080] The outer sheath 1008 may be used to deliver the shunt implant 300 to the target implantation site. That is, the shunt implant 300 may be advanced to the target implantation site at least partially within the lumen of the outer sheath 1008 such that the shunt implant 300 is at least partially retained and / or secured within a distal portion of the outer sheath 1008.

[0081] At block 904, the process 900 includes advancing the delivery system 1002 to the target implantation site. In one embodiment, illustrated in image 1014 of FIG. 10-1, this includes advancing the delivery system 1002 into the coronary sinus 130 to the target implantation site adjacent a wall 1016 that separates the coronary sinus 130 from the left atrium 104. Access to the target wall 1016 and left atrium 104 via the coronary sinus 130 may be achieved using any suitable or desired procedure. For example, various access routes may be utilized in manipulating guidewires and catheters in and around the heart to deploy a shunt. In some embodiments, access may be achieved through the subclavian or jugular vein into the superior vena cava (not shown), into the right atrium 110, and from there into the coronary sinus 130. Alternatively, the access route may begin in the femoral vein and enter the heart through the inferior vena cava (not shown). Other access routes may also be used, each of which typically utilizes a percutaneous incision through which a guidewire and catheter are inserted into the vascular system, usually through a sealed introducer, from which the system may be designed or configured to allow the physician to control the distal end of the device from outside the body.

[0082] In some implementations, the guidewire 1010 is introduced through the subclavian or jugular vein, through the superior vena cava, and into the coronary sinus 130 via the right atrium 110. The guidewire 1010 may be arranged in a spiral configuration within the left atrium 104, which may help secure the guidewire in place. Once the guidewire 1010 provides a pathway, an introducer sheath may be routed along the guidewire 1010 into the patient's vasculature, for example, by use of a dilator. A deployment delivery catheter / system may be advanced through the superior vena cava to the coronary sinus 130 of the heart, where the introducer sheath may provide a hemostatic valve to prevent blood loss. In some examples, the deployment catheter may function to create and prepare an opening (e.g., create a puncture) in the wall 1016 of the coronary sinus 130 / left atrium 104, and a separate deployment delivery system is used to deliver the shunt implant 300. In other embodiments, the same system / catheter (e.g., delivery system 1002) may be used as both a fully functional puncture preparation and implant delivery. The term "delivery system" may be used to refer to a catheter or introducer that has one or both of these functions.

[0083] In FIG. 9-2, at block 906, the process 900 includes advancing a delivery system 1002 through an opening 1018 formed in the wall 1016, as shown in image 1020 of FIG. 10-2. For example, the guidewire 1010 may be positioned to run through the opening 1018 prior to its penetration by the nosecone 1012 of the delivery system 1002. The opening 1018 may be initially formed using a needle (not shown) associated with the delivery system 1002 or another delivery system implemented prior to block 906. In some implementations, the nosecone feature 1012 may be used to at least partially dilate the opening 1018, which may have been previously dilated using a balloon dilator or other device.

[0084] At block 908, the process 900 includes deploying the shunt implant 300 using the delivery system 1002. For example, the outer sheath 1008 can be translated / retracted proximally while the inner sheath 1006 remains relatively fixed (e.g., the outer sheath 1008 is removed to reveal the inner sheath 1006), thereby releasing one or more anchor arms 312 of the anchor frame 310 on the atrial side of the wall 1016, as shown in image 1022 of FIG. 10-2. The outer sheath 1008 can continue to translate proximally to deploy / position the remaining portion of the shunt implant 300 (e.g., the adjustable frame 320) within the opening 1018 and release / deploy one or more other anchor arms 312 of the anchor frame 310 on the wall 1016 of the coronary sinus 130. The anchor arms 312 can be configured to pinch / press against the wall 1016 in an opposing manner to hold the shunt implant 300 in place within the opening 1018 .

[0085] The shunt implant 300 may allow blood flow to be shunted through the implant device 300 from the left atrium 104 to the right side of the heart via the coronary sinus 130. In an embodiment, when the shunt implant 300 is initially deployed within the opening 1018, the diameter of the adjustable frame 320 may be generally the same as when the shunt implant 300 is loaded onto the delivery system 1002, even though the anchor arms 312 of the anchor frame 310 may be expanded / released to hold the shunt implant 300 in place. Here, the radial outward / expansion force of the barrel 304(A) of the anchor frame 310 (when released from the delivery system 1002) is generally not sufficient to change the diameter / size of the barrel 304(B) of the adjustable frame 320. Although the shunt implant 300 is shown within the left atrium / coronary sinus wall, the shunt implant 300 may be positioned between other heart cavities / vessels, such as between the left and right atria and / or other anatomical features.

[0086] In FIG. 9-3, at block 910, the process 900 includes setting an initial size of the shunt implant 300. For example, as shown in image 1024, an expansion device / instrument 1026 may be advanced / inserted over the guidewire 1010 (and / or through the delivery system 1002) and used to radially expand / dilate the lumen through a central portion of the shunt implant 300. This may expand / dilate the diameter of the adjustable frame 320 to establish / define / control the amount of blood flow shunted between the left atrium 104 and the coronary sinus 130. In the illustrated embodiment, the expansion device 1026 includes a balloon / balloon catheter configured to radially expand, such as when positioned within the shunt implant 300. Additionally, the expansion device 1026 is shown as being implemented within the delivery system 1002. However, the expansion device 1026 may include other types of expansion devices and / or may be implemented as a stand-alone device or in conjunction with other systems.

[0087] At block 912, the process 900 may include determining a physiological parameter(s) (e.g., a value of the parameter(s)) associated with the anatomical feature. This may include determining the amount / volume / velocity of blood flow between the left atrium 104 and the coronary sinus 130, determining blood pressure in the left atrium 104 / coronary sinus 130 / right atrium 110 / another anatomical cavity / feature, a ratio of blood flow (e.g., volume, velocity, etc.) or pressure in one anatomical cavity / vessel to blood flow or pressure in another anatomical cavity / vessel, etc. In some examples, a sensor within the cavity(s) / vessel(s) may provide data / readings indicative of such parameter(s) or data used to determine such parameter(s), and such a sensor may be positioned on the distal end of the delivery system 1002 / another device, positioned on the shunt implant 300, implanted within the anatomical cavity / feature, etc. Additionally, in some embodiments, an echocardiogram or another imaging technique may be implemented to determine the parameter(s). In still further embodiments, other techniques may be used to determine the parameter(s). The parameter(s) are typically determined while the expansion device 1026 and / or delivery system 1002 are removed from the anatomical cavity / feature, such as by removing the expansion device 1026 / delivery system 1002 from the heart or patient, so that a more normal reading can be obtained. In some examples, the parameter(s) may be determined while a medical procedure is being performed (e.g., in the same procedure to implant the shunt implant 300).

[0088] At block 914, the process 900 may include determining whether the parameter(s) meet one or more criteria (e.g., a desired / predetermined pressure / volume / rate). For example, the parameter(s) may be compared to a threshold(s), an input to a function, etc. If the parameter(s) do not meet the one or more criteria (e.g., less than / greater than a threshold, etc.), the process 900 may proceed to block 916 (i.e., the "no" branch) of FIG. 9-4. In this path, the shunt implant 300 is further adjusted to establish an appropriate amount of shunt. In contrast, if the parameter(s) meet one or more criteria, the process 900 may proceed to block 918 (i.e., the "yes" branch) of FIG. 9-5.

[0089] In FIG. 9-4, at block 916, the process 900 may include adjusting the size of the shunt implant 300. For example, as shown in image 1028 of FIG. 10-4, an expansion device 1026 or another expansion device (e.g., including a larger balloon / expansion portion) may be inserted into the shunt implant 300 to further expand / expand the shunt implant 300 (e.g., adjustable frame 320), thereby increasing the amount of shunting between the left atrium 104 and the coronary sinus 130. The process 900 may return to block 912 of FIG. 9-3 to again determine the parameter(s) (e.g., recalculate the value of the parameter(s) and proceed to block 914). The process 900 may include making any number of adjustments to the shunt implant 300 (e.g., looping through block 916) to establish the appropriate amount of shunting for a particular situation.

[0090] In FIG. 9-5, at block 918, the process 900 may include withdrawing the delivery system 1002 and / or the guidewire 1010. For example, as shown in image 1030 of FIG. 10-5, the delivery system 1002 and guidewire 1010 may be translated proximally and / or removed from the patient. The shunt implant 300 may remain within the anatomy to provide a shunt between the left atrium 104 and the coronary sinus 130.

[0091] Although described in the context of implanting the shunt 300 in the wall between the coronary sinus 130 and the left atrium 104, the process 900 may be performed to implant, at least in part, the shunt 300 in other anatomical and / or tissue walls, such as the atrial or ventricular septum. The shunt 300 may also be positioned between other heart cavities / vessels, such as between the pulmonary artery and the right atrium.

[0092] Any of the various systems, devices, equipment, etc. in this disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods described herein may include sterilization of the associated systems, devices, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0093] Additional Features and Embodiments 1. A shunt system comprising: an anchor frame disposed within an opening between a first anatomical feature and a second anatomical feature and configured to expand from a collapsed state to an expanded state, the anchor frame including a self-expanding form; and an adjustable frame disposed around at least a portion of the anchor frame and configured to adjust a size to set an amount of fluid flow between the first anatomical feature and the second anatomical feature.

[0094] 2. Any embodiment herein, particularly embodiment 1, of the shunt system, wherein the anchor frame, in the expanded state, includes one or more arms extending from a central portion of the anchor frame and configured to secure the shunt system to a tissue wall.

[0095] 3. The shunt system of any embodiment herein, particularly embodiment 1 or 2, wherein the adjustable frame comprises a permanently deformable form.

[0096] 4. The shunt system of any embodiment herein, particularly embodiments 1-3, wherein the anchor frame comprises a shape memory material.

[0097] 5. The shunt system of any embodiment herein, particularly embodiments 1-4, wherein the adjustable frame comprises at least one of stainless steel, cobalt chrome, or aluminum.

[0098] 6. The shunt system of any embodiment herein, particularly embodiments 1-5, wherein at least one of the anchor frame or the adjustable frame includes a cover disposed between the anchor frame and the adjustable frame.

[0099] 7. The shunt system of any embodiment herein, particularly embodiments 1-6, wherein the anchor frame and the adjustable frame are separate frame structures that are coupled together with one or more attachment mechanisms.

[0100] 8. The shunt system of any embodiment herein, particularly embodiments 1-7, wherein the adjustable frame comprises a wire frame having a substantially cylindrical configuration.

[0101] 9. The shunt system of any embodiment herein, particularly embodiments 1-8, wherein the anchor frame includes a first anchor arm configured to contact a first tissue wall in a first anatomical feature and a second anchor arm configured to contact a second tissue wall in a second anatomical feature, the first anchor arm being angularly offset from the second anchor arm relative to a longitudinal axis of the adjustable frame.

[0102] 10. The shunt system of any embodiment herein, particularly embodiment 9, wherein at least one of the first anchor arm or the second anchor arm includes a visual marker configured to provide imaging visualization.

[0103] 11. A method of providing blood flow between a first anatomical feature and a second anatomical feature, the method comprising: advancing a delivery catheter into an opening in a tissue wall between the first anatomical feature and a second anatomical feature; deploying a shunt in the opening using the delivery catheter, the shunt including an anchor frame configured to secure the shunt to the tissue wall and an adjustable frame disposed about at least a portion of the anchor frame, the anchor frame being configured with at least one of shape memory or superelastic properties; and expanding the adjustable frame to configure an amount of blood flow between the first anatomical feature and the second anatomical feature.

[0104] 12. The method of any embodiment herein, particularly embodiment 11, further comprising determining at least one of an amount of blood flow between the first feature and the second feature or a pressure at the first anatomical feature or the second anatomical feature, and adjusting the amount of blood flow by further expanding the adjustable frame.

[0105] 13. The method of any embodiment herein, particularly embodiment 12, wherein deploying the shunt, expanding the adjustable frame, determining, and adjusting the amount of blood flow occur during the same medical procedure.

[0106] 14. The method of any embodiment herein, particularly embodiments 11-13, wherein the first anatomical feature is the left atrium of the heart and the second anatomical feature is at least one of the coronary sinus or the right atrium.

[0107] 15. The method of any embodiment herein, particularly embodiments 11-14, wherein the adjustable frame comprises a permanently deformable form.

[0108] 16. The method of any embodiment herein, especially embodiments 11-15, wherein the adjustable frame comprises at least one of stainless steel, cobalt chrome, or aluminum.

[0109] 17. The method of any embodiment herein, particularly embodiments 11-16, wherein at least one of the anchor frame or the adjustable frame includes a cover disposed between the anchor frame and the adjustable frame.

[0110] 18. The method of any embodiment herein, especially embodiments 11-17, wherein the anchor frame and the adjustable frame are separate frame structures that are coupled together with one or more attachment mechanisms.

[0111] 19. The method of any embodiment herein, particularly embodiments 11-18, wherein deploying the shunt includes releasing a first arm of the anchor frame to contact a first tissue wall in the first anatomical feature and releasing a second arm of the anchor frame to contact a second tissue wall in the second anatomical feature.

[0112] 20. A shunt system comprising: a first frame structure configured to secure the shunt system in an opening between a first anatomical feature and a second anatomical feature, the first frame structure configured to implement a compressed configuration on the delivery system and to self-expand at least partially to an expanded configuration upon release from the delivery system; and a second frame structure coupled to at least a portion of the first frame structure, configured to expand radially, and configured to regulate an amount of fluid flow between the first feature and the second feature based at least in part on a radial force from an expander.

[0113] 21. The shunt system of any embodiment herein, particularly embodiment 20, wherein the first framework includes a first anchor arm configured to contact a first tissue wall in a first anatomical feature and a second anchor arm configured to contact a second tissue wall in a second anatomical feature, the first anchor arm being angularly offset from the second anchor arm relative to a longitudinal axis of the second framework.

[0114] 22. The shunt system of any embodiment herein, particularly embodiment 20 or 21, wherein the second framework comprises a permanently deformable form.

[0115] 23. The shunt system of any embodiment herein, particularly embodiments 20-22, wherein the second framework comprises at least one of stainless steel, cobalt chrome, or aluminum.

[0116] 24. Any of the shunt systems herein, particularly embodiments 20-23, wherein at least one of the first frame structure or the second frame structure includes a cover disposed between the first frame structure and the second frame structure.

[0117] 25. The shunt system of any embodiment herein, particularly embodiments 20-24, wherein the first frame structure and the second frame structure are independent frame structures coupled together with one or more attachment mechanisms.

[0118] 26. The shunt / shunt system of any embodiment herein, particularly embodiments 1-25, wherein the shunt system is sterilized.

[0119] Additional Examples Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events are required to practice a process.

[0120] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to have its ordinary meaning and is generally intended to convey that certain examples include certain features, elements, and / or steps, but other examples do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any manner required for one or more examples, or that one or more examples necessarily include logic for determining, with or without author input or prompting, whether those features, elements, and / or steps are included in or should be performed in any particular example. Terms such as "comprising," "including," "having," and the like, are synonymous and used in their ordinary sense and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, and the like. Also, the term "or," for example, when used to connect a list of elements, is used in its inclusive sense (and not its exclusive sense) so that 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" is understood with the context to be used generally to convey that an item, term, element, etc., can be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0121] In the above description of the embodiments, it should be understood that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein can be applied to or used with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessarily required or essential to each embodiment. Thus, it is intended that the scope of the subject matter disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined by a fair reading of the following claims.

[0122] Certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements, such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from other elements having a similar or identical name (except for the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0123] Terms used in this specification (including technical and scientific terms) may have the same meaning as commonly understood by those skilled in the art to which the illustrative examples belong. Furthermore, terms such as those defined in commonly used dictionaries may be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and unless expressly defined in this specification, they may not be interpreted in an idealized or overly formal sense.

[0124] Spatially relative terms such as "outer", "inner", "upper", "lower", "below", "upper", "vertical", "horizontal", and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as illustrated in the drawings. The spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the drawings. For example, if a device shown in the drawings is turned over, a device that is positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the exemplary term "lower" may include both a lower position and an upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may have different interpretations depending on the orientation.

[0125] Unless expressly stated otherwise, comparison and / or quantitative terms such as "less," "more," "greater," and the like, are generally intended to encompass equivalence concepts. For example, "less" can mean "less than" as well as "less than" in the strictest mathematical sense.

Claims

1. 1. A shunt system comprising: an anchor frame disposed within the opening between the first anatomical feature and the second anatomical feature and configured to expand from a collapsed state to an expanded state, the anchor frame including a self-expanding configuration; an adjustable frame disposed around at least a portion of the anchor frame and configured to adjust a size to set an amount of fluid flow between the first anatomical feature and the second anatomical feature.

2. The shunt system of claim 1 , wherein the anchor frame, in the expanded state, includes one or more arms extending from a central portion of the anchor frame configured to secure the shunt system to a tissue wall.

3. The shunt system of claim 1 or claim 2, wherein the adjustable frame includes a permanently deformable configuration.

4. The shunt system of any one of claims 1 to 3, wherein the anchor frame comprises a shape memory material.

5. The shunt system of any one of claims 1 to 4, wherein the adjustable frame comprises at least one of stainless steel, cobalt chrome, or aluminum.

6. The shunt system of any one of claims 1 to 5, wherein at least one of the anchor frame or the adjustable frame includes a cover disposed between the anchor frame and the adjustable frame.

7. The shunt system of any one of claims 1 to 6, wherein the anchor frame and the adjustable frame are independent frame structures that are coupled together with one or more attachment mechanisms.

8. The shunt system of any one of claims 1 to 7, wherein the adjustable frame comprises a wire frame having a substantially cylindrical configuration.

9. The shunt system of any one of claims 1 to 8, wherein the anchor frame includes a first anchor arm configured to contact a first tissue wall in the first anatomical feature and a second anchor arm configured to contact a second tissue wall in the second anatomical feature, the first anchor arm being angularly offset from the second anchor arm relative to a longitudinal axis of the adjustable frame.

10. The shunt system of claim 9 , wherein at least one of the first anchor arm or the second anchor arm includes a visual marker configured to provide imaging visualization.

11. 1. A method of providing blood flow between a first anatomical feature and a second anatomical feature, comprising: advancing a delivery catheter into an opening in a tissue wall between the first anatomical feature and the second anatomical feature; placing a shunt within the opening using the delivery catheter, the shunt including an anchor frame configured to secure the shunt to the tissue wall and an adjustable frame disposed about at least a portion of the anchor frame, the anchor frame being configured with at least one of shape memory or superelastic properties; and expanding the adjustable frame to configure the amount of blood flow between the first anatomical feature and the second anatomical feature.

12. determining at least one of an amount of blood flow between the first feature and the second feature or a pressure at the first anatomical feature or the second anatomical feature; adjusting the amount of blood flow by further expanding the adjustable frame; and The method of claim 11 further comprising:

13. 13. The method of claim 12, wherein the placing of the shunt, the expanding of the adjustable frame, the determining, and the adjusting of the amount of blood flow occur during the same medical procedure.

14. 14. The method of any one of claims 11-13, wherein the positioning of the shunt comprises releasing a first arm of the anchor frame to contact a first tissue wall in the first anatomical feature and releasing a second arm of the anchor frame to contact a second tissue wall in the second anatomical feature.

15. 1. A shunt system comprising: a first framework structure configured to secure the shunt system in an opening between a first anatomical feature and a second anatomical feature, the first framework structure configured to implement a compressed configuration on a delivery system and to self-expand to an at least partially expanded configuration upon release from the delivery system; a second frame structure coupled to at least a portion of the first frame structure, the second frame structure configured to radially expand based at least in part on a radial force from an expander to regulate an amount of fluid flow between the first feature and the second feature.

16. The shunt system of claim 15, wherein the first framework includes a first anchor arm configured to contact a first tissue wall in the first anatomical feature and a second anchor arm configured to contact a second tissue wall in the second anatomical feature, the first anchor arm being angularly offset from the second anchor arm relative to a longitudinal axis of the second framework.

17. The shunt system of claim 15 or claim 16, wherein the second framework includes a permanently deformable configuration.

18. The shunt system of any one of claims 15 to 17, wherein at least one of the first frame structure or the second frame structure includes a cover disposed between the first frame structure and the second frame structure.

19. The shunt system of any one of claims 15 to 18, wherein the first frame structure and the second frame structure are independent frame structures coupled together with one or more attachment mechanisms.

20. The shunt system of any one of claims 15 to 19, wherein the shunt system is sterilized.

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