Implant and contrast delivery by stasis device

Abstract

The method includes delivering a medical implant and a delivery device to a tissue wall within a patient's heart. The delivery device may be attached to the medical implant. The method further includes manipulating the delivery device to position at least a portion of the medical implant in a desired location relative to the tissue wall and delivering an expandable retention device adjacent to the medical implant. The expandable retention device is configured to at least partially obstruct blood flow. The method further includes injecting a contrast agent between at least a portion of the medical implant and at least a portion of the expandable retention device, collapsing the expandable retention device, and detaching the delivery device from the medical implant.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 215,389, filed June 25, 2021, and entitled “IMPLANT AND CONTRAST DELIVERY WITH STAGNATION DEVICE,” the complete disclosure of which is incorporated herein by reference in its entirety.

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

[0003] Various medical procedures involve the placement of medical implant devices within cardiac anatomical structures, and certain physiological parameters associated with these anatomical structures, such as fluid pressure, can affect the health outlook of a patient. Summary of the Invention [Means for solving the problem]

[0004] Described herein are one or more methods and / or devices for facilitating the placement and / or visualization of a medical implant device.

[0005] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features 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. [Brief description of the drawings]

[0006] Various embodiments are illustrated in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention 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 numerals may be reused to indicate correspondence between referenced elements.

[0007] [Figure 1] FIG. 1 illustrates several access routes for manipulating guidewires and catheters in and around the heart for deployment of the compressible medical implants (eg, frames) of the present application. [Diagram 2] FIG. 2 depicts an exemplary method for deploying a medical implant described herein in which a guidewire and / or catheter is introduced through the subclavian or jugular vein, through the superior vena cava (SVC), and into the coronary sinus. [Diagram 3] FIG. 3 illustrates an exemplary shunt / anchor structure according to one or more embodiments. [Figure 4] FIG. 4 illustrates how a guidewire, according to one or more embodiments, can be initially advanced from the right atrium through the ostium or opening into the coronary sinus. [Diagram 5] FIG. 5 illustrates the introduction of a shunt deployment or delivery catheter having a soft, tapered distal tip advanced over a guidewire that remains bridging the tissue wall between the coronary sinus and the left atrium, in accordance with one or more embodiments. [Figure 6] FIG. 6 illustrates a delivery catheter advanced into the left atrium through puncture of the tissue wall, the passage being facilitated by the puncture and expansion of the soft, tapered distal tip, in accordance with one or more embodiments. [Figure 7] FIG. 7 depicts the initial deployment of a shunt, according to one or more embodiments, where a pair of distal flanges (eg, anchoring arms) expand into contact with the tissue wall within the left atrium. [Figure 8] FIG. 8 illustrates further deployment of the expandable shunt, in accordance with one or more embodiments, just before the pair of proximal flanges expand within the coronary sinus to contact the wall. [Figure 9] FIG. 9 is an enlarged view from the perspective of the coronary sinus to better illustrate the deployment of the proximal flange in accordance with one or more embodiments. [Figure 10] FIG. 10 illustrates distal advancement of a first control or actuation rod from within an inner sheath, according to one or more embodiments. [Figure 11] FIG. 11 next illustrates the release of the first proximal flange by the actuation rod, thus allowing the flange to resiliently contact the tissue wall (or at least the luminal surface of the coronary sinus) in accordance with one or more embodiments. [Figure 12] FIG. 12 illustrates retraction of the actuation rod into the side opening, according to one or more embodiments. [Figure 13] FIG. 13 illustrates the delivery catheter being retracted along the guidewire such that the shunt is fully deployed between the left atrium and the coronary sinus, according to one or more embodiments. [Figure 14] FIG. 14 illustrates an exemplary stagnation device that may be configured to at least partially occlude a blood flow path within the heart, according to one or more embodiments. [Figure 15] FIG. 15 illustrates another exemplary occlusion device that may be configured to at least partially occlude a blood flow pathway within the heart, according to one or more embodiments. [Figure 16] FIG. 16 illustrates another exemplary occlusion device that may be configured to at least partially occlude a blood flow pathway within the heart, according to one or more embodiments. [Figure 17A] FIG. 17A illustrates another exemplary occlusion device that may be configured to at least partially occlude blood flow in a blood flow pathway of the heart, according to one or more embodiments. [Figure 17B] FIG. 17B illustrates another exemplary occlusion device that may be configured to at least partially occlude blood flow in a blood flow pathway of the heart, according to one or more embodiments. [Figure 18-1] FIG. 18-1 provides a flow diagram illustrating a process for stagnating blood flow and / or visualizing one or more implants, according to one or more embodiments. [Figure 18-2] FIG. 18-2 provides a flow diagram illustrating a process for stagnating blood flow and / or visualizing one or more implants, according to one or more embodiments. [Figure 18-3] FIG. 18-3 provides a flow diagram illustrating a process for stagnating blood flow and / or visualizing one or more implants, according to one or more embodiments. [Figure 18-4] FIG. 18-4 provides a flow diagram illustrating a process for stagnating blood flow and / or visualizing one or more implants, according to one or more embodiments. [Figure 19-1] FIG. 19-1 is an image of cardiac anatomy and certain devices / systems corresponding to the operation of the process of FIG. 18-1, in accordance with one or more embodiments of the present disclosure. [Figure 19-2] FIG. 19-2 is an image of cardiac anatomy and certain devices / systems corresponding to the operation of the process of FIG. 18-2, in accordance with one or more embodiments of the present disclosure. [Figure 19-3] FIG. 19-3 is an image of cardiac anatomy and certain devices / systems corresponding to the operation of the process of FIG. 18-3, in accordance with one or more embodiments of the present disclosure. [Figure 19-4] FIG. 19-4 is an image of cardiac anatomy and certain devices / systems corresponding to the operation of the process of FIG. 18-4, in accordance with one or more embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0009] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments 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 embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable 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 helpful in understanding a particular embodiment, 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 embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments 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.

[0010] Certain reference numbers are reused across different figures in the set of figures of this disclosure as a matter of convenience for devices, components, systems, features, and / or modules that may have similar characteristics in one or more respects. However, for any of the embodiments disclosed herein, the reuse of common reference numbers in the figures does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one skilled in the art may be informed by the context as to the extent to which the use of common reference numbers may imply similarity between the referenced subject matter. The use of a particular reference number in the context of the description of a particular figure may be understood to relate 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 by the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number may be construed as sharing characteristics or being entirely independent of each other.

[0011] Certain standard anatomical terms of location are used herein to refer to animal, i.e. human, anatomical structures for the preferred embodiment. While certain spatially relative terms such as "outer", "inner", "upper", "lower", "lower", "upper", "vertical", "horizontal", "top", "bottom" 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 is understood that the spatially relative terms are intended to encompass different orientations of the elements / structures during use or operation in addition to the orientation shown 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 the subject patient or alternative orientations of the element / structure, and vice versa.

[0012] The present disclosure relates to systems, devices, and methods for delivery and / or confirmation of delivery of various cardiac shunts and / or other medical implant devices. In some implementations, the present disclosure relates to a hemocclusion device incorporating and / or associated with a cardiac shunt and / or other cardiac implant device. The term "associated with" is used herein according to 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 should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, or connected, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly. Particular examples are disclosed herein in connection with cardiac implant devices. However, it should be understood that while certain principles disclosed herein are particularly applicable to cardiac anatomical structures, devices in accordance with the present disclosure may be implanted or configured for implantation in any suitable or desired anatomical structure.

[0013] Cardiac Physiology Heart failure is a common and potentially fatal condition affecting humans, and despite maximal treatment, suboptimal clinical outcomes often result in symptoms, morbidity and / or mortality. In particular, "diastolic heart failure" refers to the clinical syndrome of heart failure occurring in the setting of preserved left ventricular systolic function (ejection fraction) and in the absence of major valvular disease. The condition is characterized by a stiff left ventricle with reduced compliance and impaired relaxation, which leads to increased end-diastolic pressure. Approximately one-third of heart failure patients have diastolic heart failure, and there are very few, if any, proven effective treatments.

[0014] Symptoms of diastolic heart failure are due, at least in large part, to elevated pressure in the left atrium. Elevated left atrial pressure (LAP) is present in several abnormal cardiac conditions, including heart failure (HF). In addition to diastolic heart failure, several other medical conditions, including left ventricular systolic dysfunction and valvular disease, can result in elevated pressure in the left atrium. Both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) can present with elevated LAP. It is hypothesized that both HF subpopulations would benefit from a reduction in LAP, which in turn reduces the left ventricular systolic preload, the left ventricular end diastolic pressure (LVEDP). It can also reduce pressure in the pulmonary circulation, reduce the risk of pulmonary edema, improve breathing, and improve patient comfort.

[0015] The following includes a general description of human cardiac anatomy that is relevant to certain inventive features and embodiments disclosed herein and is included to provide a context for certain aspects of the present disclosure. In humans and other vertebrates, the heart is a hollow muscular organ with four pumping chambers, with the left and right atria and the left and right ventricles each equipped with their own one-way valves. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves, each attached to an annulus that comprises a dense fibrous ring that is directly or indirectly attached to the atrial and ventricular muscle fibers. Each annulus defines a flow orifice. The four valves ensure that blood does not flow in the wrong direction during the cardiac cycle, i.e., blood does not flow backwards through the valves. Blood flows from the venous system and the right atrium through the tricuspid valve to the right ventricle, and then from the right ventricle through the pulmonary valve to the pulmonary artery and lungs. The oxygenated blood then flows from the left atrium through the mitral valve to the left ventricle and finally from the left ventricle through the aortic valve to the aortic / arterial system.

[0016] Heart failure is a common and potentially fatal condition affecting humans, and despite maximal treatment, suboptimal clinical outcomes often result in symptoms, morbidity and / or mortality. In particular, "diastolic heart failure" refers to the clinical syndrome of heart failure occurring in the setting of preserved left ventricular systolic function (ejection fraction) and in the absence of major valvular disease. The condition is characterized by a stiff left ventricle with reduced compliance and impaired relaxation, which leads to increased end-diastolic pressure. Approximately one-third of heart failure patients have diastolic heart failure, and there are very few, if any, proven effective treatments.

[0017] Symptoms of diastolic heart failure are due, at least in large part, to elevated pressure in the left atrium. Elevated left atrial pressure (LAP) is present in several abnormal cardiac conditions, including heart failure (HF). In addition to diastolic heart failure, several other medical conditions, including left ventricular systolic dysfunction and valvular disease, can result in elevated pressure in the left atrium. Both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) can present with elevated LAP. It is hypothesized that both HF subpopulations would benefit from a reduction in LAP, which in turn reduces the left ventricular systolic preload, the left ventricular end diastolic pressure (LVEDP). It can also reduce pressure in the pulmonary circulation, reduce the risk of pulmonary edema, improve breathing, and improve patient comfort.

[0018] Pulmonary hypertension (PH) is defined as an increase in the mean pressure in the main pulmonary artery. PH can result from many different causes, but has been shown to increase mortality in all patients. The fatal form of PH occurs in the very small branches of the pulmonary arteries and is known as pulmonary arterial hypertension (PAH). In PAH, cells inside the small arteries grow due to injury or disease, reducing the area inside the artery and thickening the arterial walls. As a result, these small pulmonary arteries narrow and stiffen, restricting blood flow and increasing upstream pressure. This increase in pressure in the main pulmonary artery is commonly associated with all forms of PH, regardless of the underlying cause. Despite previous attempts, improved methods are needed to reduce the pressure increase in the left atrium, as well as other susceptible heart chambers such as the pulmonary artery.

[0019] The present disclosure provides methods and devices for delivering implants, occlusion devices, and / or similar devices to desired locations within the human body. The term "implant" is used herein according to its plain and ordinary meaning and may refer to any medical implant, frame, valve, shunt, stent, anchor, and / or similar device for use in treating various conditions of the human body. The terms "stasis device", "means for stasis" and / or "means for stasis of blood flow" are used herein according to their plain and ordinary meaning and may refer to any device that may be configured to occlude, slow, impede, block, stagnate, and / or otherwise affect the flow of blood and / or various other fluids (e.g., contrast media) within one or more blood flow pathways of the heart. The implants and / or stasis devices may be delivered via catheters (i.e., transcatheter) for various medical procedures and may have a generally rigid and / or flexible structure. The term "catheter" is used herein according to its broad and ordinary meaning and may include any tube, sheath, steerable sheath, steerable catheter, and / or any other type of elongated tubular delivery device with an inner lumen configured to slidably receive an instrument, such as for positioning within the atrium or coronary sinus, including, for example, a delivery catheter and / or cannula. In some cases, the implant and / or retention device may be constructed of a shape memory alloy (e.g., Nitinol) and / or may have a predefined shape and / or configuration. The implant and / or retention device described herein may be configured to be shaped and / or compressed to fit within a catheter.

[0020] Some methods for delivery of medical implants (e.g., shunt implants) may involve the injection of a contrast agent at or near the delivered implant. For example, the injection of the contrast agent may be performed after the distal and / or proximal arms of the implant have been secured and / or positioned against the tissue wall. The injection of the contrast agent can provide a means of visualizing the implant and / or the area around the implant to determine if the tissue wall has been properly captured by the distal and / or proximal arms of the implant. However, the concentration of the contrast agent can be rapidly reduced, at least in part due to rapid blood flow around the implant, making identification of the implant configuration very difficult. This difficulty can be further complicated by an inadequate fluoroscopy system.

[0021] In some cases, an auxiliary device may be utilized in conjunction with a delivery catheter (e.g., delivered separately from the delivery catheter) to impede flow within the blood flow pathway, however, limited space within the blood flow pathway may make it difficult or impossible to accommodate the catheter and the auxiliary device.

[0022] The anchoring arms (e.g., flanges) of the medical implant may be configured to extend into various regions of the heart, including the left atrium and / or coronary sinus. Blood flow through such regions may cause displacement of such implants and / or make it difficult to visualize the implants using contrast agents. Contrast agents may be used in certain procedures to visualize anatomical structures and / or devices within the body. The contrast agents may be visualized using x-ray and / or other systems and / or may allow a physician to determine the location of the medical implant through analysis of the empty space around the contrast agent.

[0023] Some embodiments of the present disclosure provide methods and / or systems for at least partially stagnating and / or impeding fluid flow through a blood flow pathway (e.g., the coronary sinus) before, during, and / or after injection of a contrast agent (e.g., an iodine radiopaque material) at or near the delivered implant. When flow is impeded, the contrast agent remains highly concentrated, thereby providing a means to properly visualize and / or assess the positioning and / or configuration of the implant.

[0024] The one or more retention devices may be configured to be delivered along with one or more implants (e.g., shunt implants) to an implantation site (e.g., a tissue wall separating the coronary sinus and the left atrium) via a catheter / sheath (e.g., an atrial shunt delivery catheter (ASDC)). During delivery, the retention device and / or the one or more implants may be at least partially surrounded by an outer sheath and / or crimped onto an inner sheath. The outer sheath may be retracted until at least a first portion of the implant (e.g., a distal arm of the implant) is exposed. The catheter / inner sheath may be retracted to allow the distal arm to seat against a first (e.g., left atrium) side of the tissue wall. The outer sheath may then be retracted until a second portion (e.g., a proximal arm) and / or the entire implant is exposed. An actuation rod and / or similar device attached to at least a portion of the implant (e.g., a proximal arm) may be extended to position a portion of the implant against a second (e.g., coronary sinus) side of the tissue wall. The term "actuation rod" is used herein according to its clear and ordinary meaning and may include any delivery device, delivery arm, delivery rod, control device / arm / rod, and / or other device configured to be attached to and / or detached from the medical implant, and / or moved and / or manipulated as necessary to facilitate placement and / or delivery of at least a portion of the medical implant. The outer sheath may be further retracted to expose at least a portion of the stasis device. Exposing the stasis device may be configured to cause expansion of the stasis device, although additionally or alternatively, the stasis device may be configured to be manually expanded. Contrast medium may then be injected at or near the implant. In the expanded configuration, the stasis device may be configured to at least partially stagnate the flow of blood and / or contrast medium through the blood flow path. As a result, the stasis device may be configured to cause a higher concentration of contrast medium in the evaluation area, allowing the physician to make better decisions regarding the location and / or configuration of the implant.

[0025] Since visualization of the implanted device is most effective when the contrast agent is located around the implanted device to which it is delivered, it may be important to retain the contrast agent around the implanted device. However, blood flow through the opening through which the medical implant may be secured may make it very difficult to contain the contrast agent. Therefore, it may be beneficial to have a stasis device located near and / or downstream of the medical implant to provide effective visualization of the medical implant. In some cases, stasis of blood flow downstream of the implanted device may allow some blood and / or contrast agent to leak upward from the coronary sinus into the left atrium, where it may pool along the left atrial wall and provide effective imaging of the distal anchor arm of the medical implant along the left atrial wall.

[0026] The retention device may advantageously be configured to be delivered and / or used in combination with and / or simultaneously with one or more medical implants. For example, the retention device and the medical implant may be configured to be crimped onto the same inner sheath and / or surrounded by the same outer sheath. The retention device may advantageously have a relatively small profile and / or be configured to assume a folded configuration to accommodate the medical implants and / or various delivery systems.

[0027] 1 illustrates several access routes for manipulating guidewires and catheters in and around the heart 1 for deploying the compressible medical implants (e.g., frames) of the present application. For example, access can be gained from above into the superior vena cava (SVC) 15, the right atrium (RA) 5, and from there into the coronary sinus (CS) 19 via either the subclavian or jugular vein. Alternatively, an access route can begin in the femoral vein and through the inferior vena cava (IVC) 14 into the heart 1. Other access routes can also be used, and each 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 physician controls the distal end of the device from outside the body.

[0028] 2 depicts an exemplary method for deploying a medical implant 10 described herein in which a guidewire and / or catheter 16 is introduced through the subclavian or jugular vein, through the SVC 15, and into the coronary sinus 19. In some instances, a guidewire is used to provide a pathway, and then an introducer sheath (not shown) may be routed along the guidewire and into the patient's vasculature, typically with the use of a dilator. FIG. 2 shows the deployment catheter 16 extending from the SVC 15 into the coronary sinus 19 of the heart 1, where the deployment catheter 16 passes through the introducer sheath, which provides a hemostasis valve to prevent blood loss.

[0029] In one embodiment, the deployment catheter 16 may be approximately 30 cm long, and the guidewire may be somewhat longer for ease of use. In some embodiments, the deployment catheter may function to create and prepare an opening in the wall of the left atrium 2, and a separate placement or delivery catheter will be used to deliver the expandable implant 10. In other embodiments, the deployment catheter may be used as both a fully functional puncture preparation and implant placement catheter. In this application, the terms "deployment catheter" or "delivery catheter" are used to refer to a catheter or introducer that has one or both of these functions.

[0030] Because the coronary sinus 19 is largely continuous around the left atrium 2, there are a variety of possible acceptable placements for the implant 10. The site selected for placement of the stent may be within an area where the tissue of a particular patient is thin or less dense, as previously determined by non-invasive diagnostic means, such as CT scan or radiography, fluoroscopy or intravascular coronary echo (IVUS).

[0031] Some methods of reducing LAP involve utilizing an implant 10 between the left atrium 2 and the right atrium 5 through the interatrial septum therebetween. This is a convenient approach since the two structures are adjacent and transseptal access is a common method. However, there may be the possibility of emboli migrating from the right side of the heart to the left, creating a risk of stroke. This event should only occur when the right atrial pressure exceeds the left atrial pressure, primarily during a discrete event such as coughing, sneezing, Valsalva maneuver, or bowel movement. The anatomical location of the septum would naturally allow emboli to move freely between the atria when the implant 10 is present and the pressure gradient is reversed. This may be mitigated by the valve or filter element of the implant 10, but there is still a risk of emboli crossing over.

[0032] An implant in the coronary sinus 19 offers several different advantages, primarily that there is a much lower chance of there being an embolus in the coronary sinus 19 for several reasons. First, the exit of blood from the coronary vasculature into the right atrium 5 has just passed through the capillaries and is essentially filtered blood. Second, the ostium of the coronary sinus 19 in the right atrium 5 is often partially covered by a false valve called the Thebesian valve. The Thebesian valve is present in >60% of hearts, although not always present, and some studies have shown that it acts as a natural "watchdog" for the coronary sinus to prevent emboli from entering when right atrial pressure spikes. Third, the pressure gradient between the coronary sinus 19 and the right atrium 5 where it exits is very low, and a thrombus in the right atrium 5 is more likely to remain there. Fourth, if an embolus does enter the coronary sinus 19, there will be a much larger gradient between the right atrium 5 and the coronary vasculature than between the right atrium 5 and the left atrium 2. The embolism will most likely travel further down the coronary vasculature until right atrial pressure returns to normal and the embolism then returns directly to the right atrium 5 .

[0033] Some additional benefits of positioning the implant 10 between the left atrium 2 and the coronary sinus 19 are that this anatomical structure is less mobile (more stable) than the septum, thus preserving the septum for later transseptal access for alternative therapies, and potentially having other therapeutic benefits. By shunting left atrial blood to the coronary sinus 19, sinus pressure may be increased by a small amount. This may cause blood in the coronary vasculature to move more slowly through the heart, increasing perfusion and oxygen transfer, which may be more efficient and may also help the dying myocardium recover. Preserving transseptal access is also a huge advantage, as HF patients often have many other comorbidities, such as atrial fibrillation (AF) and mitral regurgitation (MR), and some therapies to treat these conditions require a transseptal approach.

[0034] The implant 10 may also be positioned within chambers and / or blood vessels and / or between other ventricular chambers, such as between the pulmonary artery and the right atrium 5. The implant 10 may be desired to be implanted within the wall of the pulmonary artery using a catheter approached from above and threaded through the pulmonary artery using a deployment tool described herein. As explained above, pulmonary hypertension (PH) is defined as an increase in mean pressure in the main pulmonary artery. If a pressure difference causes flow in that direction, blood will flow through the implant 10 from the pulmonary artery to the right atrium 5, thereby attenuating pressure and reducing damage to the pulmonary artery. The purpose is to attenuate pressure spikes in the pulmonary artery. The implant 10 may also extend from the pulmonary artery to other heart chambers (e.g., the left atrium 2) and / or blood vessels. In some embodiments, the implant 10 may further include a one-way valve to prevent backflow, or a check valve that allows blood to pass only above a specified pressure.

[0035] Some implants 10 described herein may be at least partially compressible and / or expandable. Additionally, in some embodiments, the implant 10 may have various characteristics and / or may be used in combination with devices having various barriers to prevent, inhibit, and / or contain tissue growth. The implant 10 may be configured to at least partially prevent, inhibit, reduce, contain, and / or otherwise modify tissue growth and / or tissue ingrowth at and / or around the implant 10 and / or within openings in tissue walls. The implants 10 described herein may have various characteristics to simplify and / or improve the delivery procedure for the surgeon. For example, the implant 10 may be at least partially flexible, compressible, and / or resilient so that the implant 10 can be shaped and / or molded as needed / desired to fit into delivery catheters having various sizes and / or shapes.

[0036] Additionally, the implant 10 may be configured to maintain various openings created in tissue walls having various sizes and / or shapes. The tissue walls may be located between a first anatomical chamber (e.g., the coronary sinus) and a second anatomical chamber (e.g., the left atrium). In some embodiments, openings may be created through the tissue walls and / or the implant 10 (e.g., the central flow portion and / or the central flow portion of the implant 10) may be configured to at least partially fit within the openings. The openings may represent blood flow pathways between the first anatomical chamber and the second anatomical chamber. In some embodiments, the implant 10 may be configured to maintain openings and / or blood flow pathways from the first anatomical chamber to the second anatomical chamber.

[0037] Cardiac Shunt Implants FIG. 3 illustrates an exemplary shunt / anchor structure 150 (e.g., medical implant) according to one or more embodiments. The shunt structure 150 may represent an embodiment of a cardiac implant that may be configured to be delivered in combination with one or more retention devices according to certain embodiments disclosed herein. The shunt structure 150 may be an expandable shunt. When expanded, the central flow channel 166 of the shunt 150 may define a generally circular or elliptical opening. The channel 166 may be configured to hold the sides of the puncture opening to a tissue wall to form a blood flow pathway between heart chambers or blood vessels separated by the tissue wall. For example, the shunt 150 may be configured to be embedded in a wall separating the coronary sinus and the left atrium. The central flow channel 166 may be formed in part by a pair of side walls 170a, 170b defined by a generally parallel arrangement of thin struts 179 that form an array of parallelogram-shaped cells or openings 180. In some embodiments, the substantially complete shunt 150 is formed by superelastic struts that are configured to be compressed and fitted into a catheter (not shown) and then expanded and return to a relaxed shape as shown in FIG. 3.

[0038] Forming the shunt 150 using multiple interconnected struts forming cells therebetween may serve to at least partially increase the flexibility of the shunt, thereby allowing for its compression and expansion at the implantation site. The interconnected struts around the central flow channel 166 advantageously provide a cage with sufficient rigidity and structure to hold tissue at the puncture in an open position. The end walls 172a, 172b of the central flow channel 166 may serve to connect the side walls 170a, 170b and extend between the distal and proximal flanges or arms 152, 154 on each side. The side walls 170a, 170b and the end walls 172a, 172b together may define a tubular lattice as shown. The end walls 172a, 172b may include thin struts 179 that extend at a slight angle from the central flow axis of the shunt 150.

[0039] The illustrated shunt 150 includes struts that define a tubular or circular lattice of open cells that form a central flow channel 166, although in some embodiments the structures making up the channel form a substantially continuous wall surface through at least a portion of the channel 166. In the illustrated embodiment, the angle of the shunt structure 150 may facilitate not only collapsing the shunt into a delivery catheter (not shown), but also the expansion of the flanges / arms 152, 154 on either side of the target tissue wall. The central flow channel 166 may remain essentially unchanged between the collapsed and expanded states of the shunt 150, whereas the flanges / arms 152, 154 may transition into and out of alignment with the angled flow channel.

[0040] The shunt 150 may comprise a leading flange or end 160a of the first distal flange 152a, which may be configured to emerge distally from the catheter and subsequently emerge from the remainder of the first distal flange 152a. The second distal flange 152b may comprise an end 160b. The first distal flange 152a and the second distal flange 152b may be fully ejected from the catheter or may extend in generally opposite directions. In some embodiments, the first distal flange 152a may be longer than the second distal flange 152b.

[0041] The flanges 152a, 152b may be configured to expand into contact with a tissue wall (e.g., the left atrial side of the left atrial wall). The catheter may then be retracted until the distal tip of the catheter is located within the coronary sinus, and then the proximal flange 154 may be deployed. One or more delivery devices (e.g., a first actuating rod and / or a second actuating rod) may be configured to engage different locations on the expandable shunt 150 to control its ejection from the catheter. For example, a first actuating rod may engage with the leading flange or end 164a of the first proximal flange 154a, while a second actuating rod may engage with the trailing flange or end 164b of the second proximal flange 154b. The first and second actuating rods may be configured to slide axially within the catheter independently of one another. The first actuation rod may continue to advance the end 164a of the first proximal flange 154a, while the second actuation rod may be stopped to stop advancing the end 164b of the second proximal flange 154b. This allows the two flanges 154a, 154b to separate so that the shunt 150 can assume its relaxed, expanded configuration. More specifically, the central flow tube 166 (or "barrel" portion) gradually opens until it reaches a fully expanded state. The two actuation rods may carry thin, elongated release rods that may be retracted to release the rods from engagement with the proximal flanges 154a, 154b.

[0042] While certain embodiments of shunts disclosed herein include flow channels having a substantially circular cross-section, in some embodiments, shunt structures according to the present disclosure have oval, rectangular, diamond, or elliptical flow channel configurations. For example, relatively elongated sidewalls compared to the illustrated configuration of Figure 3 may produce rectangular or oval flow channels. Shunt flow channels of such shapes may be desirable for larger punctures, yet still be configured to collapse into a relatively small delivery profile.

[0043] In some embodiments, each of the distal and proximal flanges / arms 152, 154 curl outwardly from the end walls 172a, 172b and are configured to point generally radially away from the central flow channel 166 in the expanded configuration. The expanded flanges / arms may serve to anchor the shunt 150 to the target tissue wall. Additional aspects and features of shunt, implant, and / or anchor structures that may be used in combination with the retention devices of the presently disclosed embodiments are disclosed in U.S. Patent No. 9,789,294, issued October 17, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety. Although certain embodiments are disclosed herein in the context of a shunt structure similar to that shown in FIG. 3 and described above, it should be understood that a shunt structure or other implanted device delivered and / or used in combination with a retention device according to embodiments of the present disclosure may have any type, form, structure, configuration, and / or may be used or configured to be used for any purpose, whether shunt or other purpose or function.

[0044] 4-13 are schematic diagrams showing the steps of making a puncture through the wall of the coronary sinus and placing a shunt between the coronary sinus and the left atrium, looking down on a portion of the heart with the posterior surface facing down.

[0045] As shown in FIG. 4, a guidewire 36 may first be advanced from the right atrium 5 through its ostium or opening into the coronary sinus 19. A puncture catheter 22 (e.g., inner sheath) is then advanced over the guidewire 36. The puncture catheter 22 may be introduced into the body through the proximal end of an introducer sheath (not shown). The introducer sheath may provide access to a particular vascular pathway (e.g., the jugular or subclavian vein) and / or may have a hemostatic valve therein. While holding the introducer sheath in a fixed position, the surgeon may manipulate the puncture catheter 22 to the implantation site.

[0046] FIG. 5 illustrates the introduction of a shunt deployment or delivery catheter 50 having a soft tapered distal tip 52 advanced along a guidewire 36 that remains bridging the tissue wall 30 between the coronary sinus and the left atrium 2. FIG. 6 illustrates the delivery catheter 50 advanced into the left atrium by puncturing the tissue wall 30, the passage being facilitated by the puncturing and expansion of the soft tapered distal tip 52. The delivery catheter 50 is shown in cross-section in these figures to illustrate the desired location of the expandable shunt 150 therein, just proximal to the distal tip 52. The expandable shunt 150 is shown in a collapsed, generally tubular configuration that facilitates passage through the lumen of the catheter 50. An actuation rod extending through the lumen and / or connected to the expandable shunt 150 is not shown in some of these figures for clarity, but is described below.

[0047] FIG. 7 depicts the initial deployment of the shunt 150, with a pair of distal flanges 152 (e.g., anchor arms) expanding within the left atrium 2 to contact the tissue wall 30. This expansion is initiated by retraction of the outer sheath of the delivery catheter 50 relative to the inner sheath / catheter 54. The shunt 150 sits within the annular space between the inner sheath 54 and the outer sheath 50. The inner sheath 54 passes through a central flow passage of the shunt 150. Typically, the shunt 150 is folded (crimped) into a generally tubular configuration between the two sheaths when the restrained outer sheath 50 is retracted, with the flanges straightened and springing open, as shown in FIGS. 7 and 8. As explained below, the flanges 152 expand in generally opposite directions in a common plane to form a T-shape, as opposed to expanding in a circular manner that would form an annular flange. A radiopaque marker on flange 152 may be provided to facilitate ready positioning within the left atrium.

[0048] 8 illustrates further deployment of the expandable shunt 150 just before the pair of proximal flanges 154 expand into the coronary sinus 19 and contact the wall 30. More specifically, the physician retracts the inner sheath 54 and the entire shunt 150 until the two distal flanges 152 contact the tissue wall 30. This may be felt by tactile feedback or by again confirming the location of the distal flanges 152 by visualization with a radiopaque material. The outer sheath 50 is also shown retracted further proximally to expose the pair of proximal flanges 154. At this stage in the deployment of the shunt 150, the proximal flanges 154 are held by the actuation rod and prevented from expanding into the coronary sinus 19.

[0049] 9 is an enlarged view from the perspective of the coronary sinus to better illustrate the deployment of the proximal flange 154. As described above, the inner sheath 54 retracts so that the distal flange 152 closely engages the left atrial tissue wall 30. The proximal flange 154 remains constrained in general alignment with the inner sheath 54.

[0050] 10 illustrates distal advancement of a first control or actuating rod 162 (e.g., a delivery device) from within the inner sheath 54. The actuating rod 162 emerges from a side opening in the inner sheath 54 and is coupled to the leading or first proximal flange 154a such that the flange can expand to its relaxed position as shown. Once the flange 154 is positioned within the puncture wound, but considered prior to its release from the delivery catheter 50 and / or actuating rod 162, contrast can be injected in the vicinity to determine if the shunt is properly positioned. That is, contrast visible in the gap between the opposing flanges 152, 154 indicates that the flanges are not on opposite sides of the tissue wall 30. Thus, the shunt 150 can be further manipulated to change position.

[0051] FIG. 11 then illustrates the release of the first proximal flange 154a by the actuation rod 162, thus allowing the flange to elastically contact the tissue wall 30 (or at least the luminal surface of the coronary sinus). The physician then causes the actuation rod 162 to retract into the side opening, as shown in FIG. 12. A second control or actuation rod (not shown) can then release the trailing or second proximal flange 154b, which also allows it to elastically contact the tissue wall 30. At this point, the shunt 150 is completely free from the delivery catheter 50, but the inner sheath 54 remains extended through the central flow passage of the shunt. The opposing leading flanges 152a, 154a form a clamping pair of flanges, as do the opposing trailing flanges 152b, 154b. As described, the flange clamp pair applies a small compressive force to the tissue wall 30 to hold the shunt 150 in place, however, the gap separating the flange clamp pair is desirably calibrated to avoid over-clamping or necrosis of tissue.

[0052] 13. The delivery catheter 50 is shown retracted along with the guidewire 36 so that the shunt 150 is fully deployed between the left atrium and the coronary sinus. The guidewire 36 is then also retracted.

[0053] A shunt to the coronary sinus offers several different advantages, primarily that it is much less likely that there will be an embolus in the coronary sinus for several reasons. First, the drainage of blood from the coronary vasculature into the right atrium has just passed through the capillaries and is essentially filtered blood. Second, the ostium of the coronary sinus in the right atrium is often partially covered by a false valve called the Thebesian valve. The Thebesian valve is present in >60% of hearts, although not always, and some studies have shown that it acts as a natural "watchdog" for the coronary sinus to prevent emboli from entering when right atrial pressure spikes. Third, the pressure gradient between the coronary sinus where it drains and the right atrium is very low, and a thrombus in the right atrium is more likely to remain there. Fourth, in the event that an embolus does enter the coronary sinus, there will be a much larger gradient between the right atrium and the coronary vasculature than between the right atrium and the left atrium. The embolism will most likely travel further down the coronary vasculature until right atrial pressure returns to normal and the embolism is then returned directly to the right atrium.

[0054] Some additional benefits of locating a shunt between the left atrium and the coronary sinus are that this anatomical structure is less mobile (more stable) than the septum, thus preserving the septum for later transseptal access for alternative therapies and potentially having other therapeutic benefits. By shunting left atrial blood to the coronary sinus, sinus pressure may be increased by a small amount. This may cause blood in the coronary vasculature to move more slowly through the heart, increasing perfusion and oxygen transfer, which may be more efficient and may also help dying myocardium recover. A device designed to do this is the Neovasc Reducer. Preserving transseptal access is also a huge advantage, as HF patients often have many other comorbidities, such as atrial fibrillation (AF) and mitral regurgitation (MR), and some therapies to treat these conditions require a transseptal approach.

[0055] The shunt 150 may also be positioned between other ventricular chambers, such as between the pulmonary artery and the right atrium. The shunt 150 is preferably implanted in the wall of the pulmonary artery using a catheter that is approached from above and threaded through the pulmonary artery using a deployment tool described herein. As explained above, pulmonary hypertension (PH) is defined as an increase in the mean pressure in the main pulmonary artery. If a pressure difference causes flow in that direction, blood will flow through the shunt 150 from the pulmonary artery to the right atrium, thereby attenuating pressure and reducing damage to the pulmonary artery. The purpose is to attenuate pressure spikes in the pulmonary artery. The shunt 150 may also extend from the pulmonary artery to other heart chambers (e.g., the left atrium) and / or blood vessels. Although not preferred and not shown, the shunt 150 may further include a one-way valve to prevent backflow, or a check valve that allows blood to pass only above a specified pressure.

[0056] Stagnation device 14 illustrates an exemplary stagnation device that may be configured to at least partially occlude a blood flow path in a heart, according to one or more embodiments. The stagnation device may be configured to be delivered via an inner sheath 54 (e.g., a catheter and / or a puncture catheter), an outer sheath 50 (e.g., a catheter), and / or a similar device. In some embodiments, the stagnation device may be at least partially expandable such that the stagnation device may be configured to expand from a compressed configuration (e.g., while at least partially enclosed within the outer sheath 50) to an expanded configuration shown in FIG. 14. The stagnation device may be configured to at least partially surround the inner sheath 54.

[0057] In some embodiments, the retention device may comprise an infrastructure and / or framework that may include one or more cords 1402. The term “cord” is used herein according to its clear and ordinary meaning and may refer to any line of rigid and / or flexible material, including wire, suture, string, bar, and / or rod. The cord may be constructed from one or more materials, which may include metal (e.g., Nitinol) and / or plastic. The one or more cords 1402 may have a generally flexible construction. For example, the cord 1402 may be constructed at least in part from a shape memory alloy (e.g., Nitinol) and / or other material configured to bend and / or otherwise bend in response to an external force. In some embodiments, the one or more cords 1402 may be shape-set into a desired configuration. In the embodiment shown in FIG. 14, the retention device may comprise a first cord 1402a, which may be elliptical in shape and / or may form a partial elliptical shape. The first cord 1402a may be configured to couple with an end portion of another cord 1402 (e.g., the second cord 1402b), which may be configured to extend generally longitudinally along the inner sheath 54.

[0058] One or more of the cords 1402 (e.g., the second cord 1402b) may have a generally linear and / or curved configuration. For example, the second cord 1402b and / or the other cords 1402 may be configured to extend some distance away from the inner sheath 54 and / or the longitudinal axis of the inner sheath 54 and / or the retention device. In this manner, the retention device may have a generally conical shape (e.g., at least partially conical) and / or umbrella shape, and the first cord 1402a forms an oval opening in the retention device. The second cord 1402b and / or the other cords may extend generally longitudinally along the longitudinal axis of the inner sheath 54 and / or the retention device, and / or the second cord 1402b and / or the other cords may be attached to the first cord 1402a at the end of the second cord 1402b and / or the other cords. The second cord 1402b and / or other cords may extend generally perpendicular to the first cord 1402a.

[0059] The diameter of the elliptical opening formed by first cord 1402a may be larger than the diameter of outer sheath 50 and / or the diameter of the retention device in other portions of the retention device. In some embodiments, the retention device and / or first cord 1402a may be configured to expand to a diameter approximately equal to and / or larger than the diameter of the blood flow pathway (e.g., the coronary sinus). In this manner, at least a portion of the retention device, including first cord 1402a, may be configured to expand until it contacts a wall of the blood flow pathway, thereby effectively occluding at least a portion of the blood flow pathway.

[0060] When the retention device is positioned within the outer sheath 50, one or more of the cords 1402 (e.g., second cord 1402b) may have a relatively linear configuration in response to external pressure from the outer sheath 50. When the outer sheath 50 is retracted and at least a portion of the retention device is exposed, one or more of the cords 1402 (e.g., second cord 1402b) may be configured to assume a more curved configuration and / or may be configured to expand at or near an end portion of the cord 1402 (e.g., second cord 1402b is attached to and / or extends within first cord 1402a).

[0061] In some embodiments, the stagnation device may comprise one or more covers 1405 (e.g., skirts) configured to form at least a partial barrier around an outer portion of the stagnation device. In some embodiments, the cover 1405 may form a fluid-tight barrier around an outer portion of the stagnation device and / or may comprise a porous net and / or porous mesh network of wires and / or similar devices having gaps to allow some blood flow through the cover 1405. The cover 1405 may be constructed from any suitable material, which may include polytetrafluoroethylene (PTFE) and / or similar materials.

[0062] Although a retention device is shown including a first cord 1402a, the retention device need not necessarily include an oval-shaped cord at an end portion of the retention device. For example, one or more longitudinally extending cords (e.g., second cord 1402b and / or additional cords 1402) may be individually and / or independently configured to extend outwardly and / or press against a wall of a blood flow pathway.

[0063] In some embodiments, the cover 1405 may be configured to have an at least partially folded configuration while the retention device is in a compressed configuration while within the outer sheath 50. As the retention device expands, the cover 1405 may also be configured to expand such that the folded portion of the cover may be stretched to remove the crease.

[0064] FIG. 15 illustrates another exemplary retention device 1500 comprising an inflatable and / or expandable balloon that may be configured to at least partially occlude a blood flow pathway in the heart, according to one or more embodiments. The retention device 1500 may be configured to be inflated using air and / or fluid to form an expanded shape. In some embodiments, the retention device 1500 may be configured to form a ring-shaped extension around at least a portion of the inner sheath 54. For example, the retention device 1500 may be attached to an outer surface of the inner sheath 54 and / or configured to fit within the outer sheath. The retention device 1500 may be configured to have a reduced profile while located within the outer sheath (see, e.g., outer sheath 50 in FIG. 16). Once the retention device 1500 is exposed (e.g., by retraction of the outer sheath), the retention device 1500 may be inflated to expand in all or a portion of the direction around the inner sheath 54. The stasis device 1500 may be configured to extend and / or expand to a diameter approximately equal to or greater than the blood flow pathway of the heart (e.g., the coronary sinus). The stasis device 1500 may be further configured to be deflated after inflation of the stasis device 1500. For example, the stasis device 1500 may be only temporarily inflated to at least partially occlude the blood flow pathway. After application of a contrast agent to the blood flow for visualization, the stasis device 1500 may be deflated to allow normal blood flow through the blood flow pathway.

[0065] The retention device 1500 may have a generally small profile to allow the retention device 1500 to be used in combination with a variety of other devices and / or implants. For example, the retention device 1500 may have a minimal width and / or may be configured to extend along a relatively small portion of the inner catheter 54. The retention device 1500 may have a diameter larger than the diameter of the inner sheath.

[0066] FIG. 16 illustrates another exemplary retention device 1600 comprising an inflatable and / or expandable balloon that may be configured to at least partially occlude a blood flow pathway in the heart, according to one or more embodiments. The retention device 1600 may be configured to be inflated using air and / or fluid to form an expanded shape. In some embodiments, the retention device 1600 may be configured to form a ring-shaped extension around at least a portion of the outer sheath 50. For example, the retention device 1600 may be attached to an outer surface of the outer sheath 50. The retention device 1600 may be configured to have a reduced profile during delivery. Upon and / or after delivery to the target location, the retention device 1600 may be inflated to expand in all or a portion of the direction around the outer sheath 50. The retention device 1600 may be configured to extend and / or expand to a diameter approximately equal to or greater than a blood flow pathway of the heart (e.g., the coronary sinus). The stasis device 1600 may be further configured to be deflated after inflation of the stasis device 1600. For example, the stasis device 1600 may be only temporarily inflated to at least partially occlude the blood flow pathway. After application of a contrast agent to the blood flow for visualization, the stasis device 1600 may be deflated to allow normal blood flow through the blood flow pathway.

[0067] The retention device 1600 may have a generally small profile to allow the retention device 1600 to be used in combination with a variety of other devices and / or implants. For example, the retention device 1600 may have a minimal width and / or may be configured to extend along a relatively small portion of the outer sheath 50. The retention device 1600 may have a diameter that is larger than the diameter of the inner sheath 54 and / or the outer sheath 50.

[0068] 17A and 17B illustrate another exemplary stagnation device 1700 that may be configured to at least partially occlude blood flow in a cardiac blood flow pathway, according to one or more embodiments. FIG. 17A shows a compressed configuration of the stagnation device 1700, and FIG. 17B illustrates an expanded configuration of the stagnation device 1700. The stagnation device 1700 may be configured for use as an outer sheath and / or may be configured to extend at least partially along the inner sheath 54. The stagnation device 1700 may have a generally tubular configuration to approximate the tubular shape of the inner sheath 54.

[0069] At an end portion of the retention device 1700, the retention device 1700 may include one or more expandable and / or movable petals 1706, which may be formed by slits and / or cut portions of the retention device 1700. The one or more petals 1706 may at least partially overlap one another while in the compressed configuration illustrated in FIG. 17A. One or more wires 1702 may be configured to extend from one or more of the petals 1706. For example, a first wire 1702a may be configured to attach to, engage and / or actuate a first petal 1706a of the retention device 1700. For example, the first wire 1702a may be configured to extend along and / or within the retention device 1700 and / or may be accessible to a surgeon. The first wire 1702a may be configured to be pulled rearward (e.g., away from an end portion of the retention device 1700) to apply a rearward pulling force to the first petal 1706a. In some embodiments, multiple cords 1702 may be configured to be pulled simultaneously to cause simultaneous movement of multiple petals 1706. As shown in FIG. 17B, the petals 1706 may be configured to be pulled rearward to increase the diameter of the retention device 1700 at the end portion of the retention device 1700.

[0070] In some embodiments, one or more petals 1706 may be connected via one or more webbings 1707 and / or membranes. The webbings 1707 may have a generally flexible structure and / or may be configured to stretch as the petals 1706 expand. In some embodiments, the webbings 1707 may be configured to fold (e.g., fold) while the retention device 1700 is in an unexpanded configuration and / or to expand (e.g., spread) when the retention device 1700 is in an expanded configuration. The webbings 1707 may be configured to close gaps between the petals 1706 to prevent fluid from leaking between the petals 1706.

[0071] The stasis device 1700 may be configured to at least partially prevent fluid (e.g., blood and / or contrast) from leaking into the stasis device 1700. In some embodiments, the stasis device 1700 may comprise one or more occluders configured to be activated in response to expansion of the stasis device 1700. For example, the stasis device 1700 may comprise a flap configured to extend across at least a portion of the inner lumen of the stasis device in response to separation and / or expansion of the petals 1706. The flap may represent a barrier that prevents fluid flow past the flap to enable effective flow stasis at or near the distal end of the stasis device 1700. In response to the stasis device 1700 returning to the unexpanded configuration, the flap may be configured to compress and / or press against an inner wall of the stasis device 1700.

[0072] Flow Stagnation Process 18-1, 18-2, 18-3, and 18-4 provide a flow diagram illustrating a process 1800 for stagnating blood flow and / or visualizing one or more implants according to one or more embodiments. FIGs. 19-1, 19-2, 19-3, and 19-4 are images of cardiac anatomy and certain devices / systems corresponding to the operations of process 1800 of FIGs. 18-1, 18-2, 18-3, and 18-4 according to one or more embodiments of the present disclosure.

[0073] At block 1802, the process 1800 involves delivering distal anchor arms 152 (e.g., flanges), including first distal arm 152a and / or second distal arm, of an implantation device through an opening in the tissue wall 30 and / or distal to the tissue wall 30, as shown in image 1902 of FIG. 19. Although a particular example of a delivery system is shown in FIG. 19-1, it should be understood that an implantation device according to aspects of the present disclosure may be delivered and / or implanted using any suitable or desired delivery system and / or delivery system components. Additionally, although a shunt implant device is shown, the steps of process 1800 of FIG. 18 may be applicable to other types of implantation devices.

[0074] The illustrated delivery system includes an inner catheter 54, which may be at least partially disposed within an outer sheath 50 (e.g., an outer catheter) during one or more portions of the process 1800. In some embodiments, a shunt structure may be at least partially disposed about the inner catheter 54, with the shunt structure being at least partially disposed within the outer sheath 50 during one or more portions of the process 1800. For example, the inner catheter 54 may be disposed within a barrel portion of the shunt structure, as shown.

[0075] An implantation device (e.g., a medical implant) may be delivered to the tissue wall together with or separately from a delivery device 162, which may include an actuation rod. The delivery device 162 may be attached to at least a portion of the medical implant (e.g., to the first proximal anchor arm 154a) during delivery of the medical implant through the body and / or tissue wall 30. In some embodiments, the medical implant, the delivery device 162, and / or the one or more retention devices may be configured to be delivered via the inner catheter 54 and / or the outer sheath 50. The medical implant and / or retention devices may be crimped in series along the inner catheter 54 and / or positioned in series within the outer sheath 50. For example, retracting the outer sheath 50 a first amount may expose the medical implant (but not the retention device), and / or further retracting the outer sheath 50 a second amount greater than the first amount may expose the retention device 1900 and the medical implant.

[0076] In some embodiments, the delivery system may be configured such that a guidewire may be at least partially disposed therein. For example, the guidewire may run within a region of the sheath and / or shaft of the inner catheter 54, such as within the inner catheter 54 as shown. The delivery system may be configured to be advanced over the guidewire to guide the delivery system to the target implantation site.

[0077] In some embodiments, the delivery system includes a tapered nose cone feature 52 that may be associated with the sheath 50, the catheter 54, and / or the distal end of the delivery system. In some implementations, the nose cone feature 52 may be utilized to expand an opening in a tissue wall into which an implantation device is to be implanted or through which the delivery system is advanced. The nose cone feature 52 may facilitate advancement of the distal end of the delivery system through a tortuous anatomy of a patient and / or with an outer delivery sheath or other conduit / pathway. The nose cone 52 may be a separate component from the catheter 54 or may be integrated with the catheter 54. In some embodiments, the nose cone 52 is adjacent to and / or integrated with the distal end of the outer sheath 50. In some embodiments, the nose cone 52 may include and / or be formed from multiple flap-type configurations that are urged / spread apart as the implantation device and / or any portion thereof, the inner catheter 54, or other device is advanced therethrough.

[0078] The outer sheath 50 may be used to deliver an implantation device and / or one or more retention devices to a target implantation site. That is, the implantation device and / or retention device may be advanced to the target implantation site at least partially within the lumen of the outer sheath 50 such that the implantation device and / or retention device are at least partially retained and / or secured within a distal portion of the outer sheath 50. In some embodiments, the medical implant may be removed from the outer sheath 50 by at least partially retracting the outer sheath 50 to expose at least a portion of the medical implant.

[0079] In some implementations, accessing the cardiac anatomical structure with the delivery system may be performed according to one or more procedures or steps to place a guidewire and create and / or dilate an opening between the left atrium and the coronary sinus of the patient's heart, the details of which are omitted for convenience and clarity.

[0080] Access to the target wall 30 and left atrium 2 via the coronary sinus 19 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 one or more implants and / or retention devices according to embodiments of the present disclosure. In some embodiments, access may be achieved through the subclavian or jugular vein into the superior vena cava (not shown), into the right atrium, and from there into the coronary sinus 19. 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 may typically utilize 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.

[0081] In some implementations, the guidewire is introduced through the subclavian or jugular vein, through the superior vena cava, and into the coronary sinus 19 via the right atrium. The guidewire may be arranged in a spiral configuration within the left atrium 2, which may help secure the guidewire in place. Once the guidewire provides a pathway, an introducer sheath may be routed along the guidewire into the patient's vasculature, for example, by use of a dilator. A delivery catheter may be advanced through the superior vena cava to the coronary sinus of the heart, where the introducer sheath may provide a hemostatic valve to prevent blood loss. In some embodiments, the deployment catheter may function to create and prepare an opening in the wall of the left atrium 2, and a separate deployment delivery system is used to deliver the implant device, as shown. In other embodiments, the deployment system may be used as both a fully functional puncture preparation and implant delivery catheter. In this application, the term "delivery system" is used to refer to a catheter or introducer that has one or both of these functions.

[0082] A guidewire may be positioned to run through the opening in the tissue wall 30 prior to penetration of the opening by the nosecone 52. The opening may be first formed using a needle (not shown) associated with the delivery system or other delivery system implemented prior to block 1802. In some implementations, the nosecone feature 52 may be used to at least partially dilate the opening, although the opening may have previously been dilated using a balloon dilator or other device.

[0083] At block 1804, the process 1800 involves extending, advancing, and / or manipulating an actuation rod 162 attached to the first proximal arm 154a to attach and / or secure at least a portion of the medical implant (e.g., the first proximal arm 154a) to the proximal side of the tissue wall 30, as shown in image 1904 of FIG. 19. In some embodiments, the actuation rod 162 may be manually and / or electronically controlled and / or manipulated to control the advancement of one or more portions of the implantation device. Although only a single actuation rod 162 is shown, additional actuation rods 162 may be used for delivery of other arms / flanges of the implant.

[0084] The actuation rod 162 may be configured to position the first anchor arm 154a at a desired location on the tissue wall 30. If the first anchor arm 154a is not properly positioned on the tissue wall 30, the actuation rod 162 may pull the first anchor arm 154a back and reattempt attachment of the first anchor arm 154a in the tissue wall. However, it may be difficult or impossible to re-engage and / or re-position the anchor arm 154 after the actuation rod 162 and / or additional actuation rods are detached from the first anchor arm 154a and / or additional anchor arms. Thus, prior to disengaging the actuation rod 162 from the first anchor arm 154a, contrast may be injected and / or one or more stop devices may be activated to assist in determining correct placement of the implantation device.

[0085] At block 1806, the process 1800 involves at least partially retracting the outer sheath 50 to expose at least a portion of the expandable retention device 1900 proximate at least a portion of the medical implant, as shown in image 1906 of FIG. 19. In some embodiments, the retention device 1900 may be configured to at least partially occlude, impede, retain, and / or impede blood flow through the coronary sinus 19 and / or other blood flow pathways. The retention device 1900 may have any of a variety of configurations, including a network of wires forming a wire "umbrella" configuration as shown in FIG. 19, one or more inflatable balloons, and / or an expandable tube / sheath. In some embodiments, the retention device 1900 may have a generally conical shape with a circular base and / or opening of the retention device 1900 located proximate the medical implant. The retention device 1900 may be configured to be crimped onto the inner sheath 54 and / or to assume a compressed configuration while at least partially surrounded by the outer sheath 50. In response to the outer sheath 50 being retracted to expose at least a portion of the retention device 1900, the retention device 1900 and / or the exposed portion of the retention device 1900 may be configured to at least partially expand to form an increased diameter. In some embodiments, the retention device 1900 may be configured to be at least partially expanded manually. For example, the retention device 1900 may be expanded by inflation and / or by actuating and / or pulling one or more wires attached to at least a portion of the retention device 1900.

[0086] The stasis device 1900 may be configured to at least partially occlude and / or stagnate blood flow within the coronary sinus 19. In some embodiments, the stasis device 1900 may be fluid-tight and / or configured to completely and / or significantly stagnate blood flow. However, stagnation of the total blood flow may not be required, and the stasis device 1900 may be at least partially porous to allow some blood flow through the stasis device 1900.

[0087] When the stagnation device 1900 is in the expanded configuration, contrast agent may be injected into the coronary sinus 19. In some embodiments, the contrast agent may be configured to be injected from a side opening 159 of the inner sheath 54. The side opening 159 may be the same opening used to deliver at least a portion of the implantation device (e.g., the first anchor arm 154a) from the inner sheath 54. In some embodiments, the contrast agent may be injected between at least a portion of the implantation device and the stagnation device 1900 and / or approximately below the opening and / or below the implantation device. Due to the flow stagnation provided by the stagnation device 1900, the contrast agent around the implantation device may be relatively slow moving and / or may remain relatively concentrated to allow for effective visualization of the implantation device.

[0088] In some examples, the contrast agent may be injected approximately between at least a portion of the medical implant and at least a portion of the stagnation device 1900. The stagnation device 1900 may be located downstream of the medical implant. For example, blood may naturally flow downward through the opening in the tissue wall 30 and / or toward the stagnation device 1900 and / or the outer sheath 50. The contrast agent may be configured to be injected upstream of the stagnation device 1900 and / or downstream of the medical implant. In some cases, the stagnation of flow caused by the stagnation device 1900 may cause blood and / or contrast agent to pass upward through the opening in the tissue wall 30 and / or pool along the distal side of the tissue wall 30, which may advantageously allow visualization of a distal portion of the medical implant (e.g., the first distal arm 152a).

[0089] In block 1808, the process 1800 includes extending the outer sheath 50 and / or retracting the stagnation device 1900 and folding the stagnation device 1900 and / or enclosing the stagnation device 1900 within the outer sheath 50, as shown in image 1908 of FIG. 19. The stagnation device 1900 may be folded after the injection of contrast agent and / or after the positioning and / or orientation of the implanted device is visualized by the physician. In some cases, the stagnation device 1900 may only need to be in the expanded configuration for a few seconds to provide sufficient stagnation to visualize the placement of the medical implant. However, the stagnation device 1900 may be maintained in the expanded configuration for a longer period, if necessary. In some examples, the stagnation device 1900 may be configured to cause only partial stagnation of flow (e.g., due to an at least partially porous structure of the stagnation device 1900) and may be maintained in the expanded configuration for an extended period of time while minimizing the risk of harm to the patient.

[0090] In block 1810, the process 1800 involves removing the actuating rod 162 from the implanted device, as shown in image 1910 of FIG. 19. The actuating rod 162 may be removed only after contrast injection and / or expansion of the stasis device 1900. In block 1812, the process 1800 involves storing the actuating rod 162 within the outer sheath 50, as shown in image 1912 of FIG. 19. In block 1814, the process 1800 involves removing the delivery system, including the inner sheath 54 and / or the outer sheath 50, from the coronary sinus 19 and / or from the body, as shown in image 1914 of FIG. 19.

[0091] Additional aspects and features of processes for delivering shunt structures that may be delivered and / or utilized in combination with a retention device according to embodiments of the present disclosure for implantation in the wall between the coronary sinus and the left atrium are disclosed in U.S. Patent No. 9,789,294, issued October 17, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety. Although the implantation device is shown in the left atrial / coronary sinus wall, the implantation device may be positioned between other heart chambers, such as between the left and right atrium.

[0092] Some implementations of the present disclosure relate to a method that includes delivering a medical implant and a delivery device to a tissue wall within a patient's heart. The delivery device is attached to the medical implant. The method further includes manipulating the delivery device to position at least a portion of the medical implant in a desired location relative to the tissue wall and delivering an expandable retention device adjacent to the medical implant. The expandable retention device is configured to at least partially obstruct blood flow. The method further includes injecting a contrast agent between at least a portion of the medical implant and at least a portion of the expandable retention device, collapsing the expandable retention device, and detaching the delivery device from the medical implant.

[0093] The method may further include delivering the medical implant and the expandable retention device through the first catheter. In some embodiments, the method further includes retracting the first catheter to remove the medical implant from the first catheter, and further retracting the first catheter to remove the expandable retention device from the first catheter.

[0094] In some embodiments, removing the expandable retention device from the first catheter causes the expandable retention device to expand.

[0095] The expandable retention device can comprise a network of wires configured to expand into a cone shape, hi some embodiments, the expandable retention device comprises an inflatable balloon.

[0096] In some embodiments, the method further includes delivering an expandable retention device through the inner sheath. The expandable retention device can extend from the inner sheath. The method can further include delivering an expandable retention device through the inner sheath and the outer sheath, the expandable retention device extending from the outer sheath.

[0097] The expandable retention device can include a tubular sheath having one or more expandable petals at an end portion of the expandable retention device, hi some embodiments, the one or more expandable petals are attached to a pull wire configured to expand the one or more expandable petals.

[0098] In some embodiments, the expandable retention device comprises one or more webbing between one or more expandable petals. The expandable retention device can comprise one or more flaps configured to at least partially obstruct blood flow through an inner lumen of the expandable retention device.

[0099] The medical implant may include a first anchoring arm. The delivery device may be attached to the first anchoring arm.

[0100] In some implementations of the present disclosure, a delivery system includes an expandable retention device configured to at least partially obstruct blood flow within the cardiac blood flow pathway and to compress following injection of a contrast agent within the cardiac blood flow pathway, an inner sheath configured to deliver the medical implant and the expandable retention device through the cardiac blood flow pathway and in proximity to a tissue wall of the heart, and a delivery device configured to attach to the medical implant, manipulate at least a portion of the medical implant to a desired position relative to the tissue wall of the heart, and detach from the medical implant following injection of a contrast agent within the cardiac blood flow pathway.

[0101] The delivery system may further comprise an outer sheath configured to at least partially encapsulate the expandable retention device and the medical implant and to retract and remove the medical implant and the expandable retention device from the outer sheath.

[0102] In some embodiments, removing the expandable retention device from the outer sheath causes the expandable retention device to expand. The expandable retention device can comprise a network of wires configured to expand in a conical shape.

[0103] The expandable retention device can comprise an inflatable balloon, hi some embodiments, the expandable retention device extends from the inner sheath.

[0104] In some embodiments, the expandable retention device comprises a tubular sheath at least partially enclosing the inner sheath and having one or more expandable petals at an end portion of the expandable retention device.

[0105] In some aspects, the technology described herein relates to a method that includes delivering a medical implant and a delivery device to a tissue wall within a patient's heart via an inner catheter; manipulating the delivery device to position at least a portion of the medical implant at a desired location relative to the tissue wall; delivering a retention device adjacent to the medical implant, the retention device configured to at least partially obstruct blood flow; and injecting a contrast agent between at least a portion of the medical implant and at least a portion of the retention device.

[0106] In some aspects, the technology described herein relates to methods by which a delivery device is attached to a medical implant.

[0107] In some aspects, the technology described herein relates to methods that further include detaching the delivery device from the medical implant after injection of the contrast agent.

[0108] In some aspects, the technology described herein relates to methods where the retention device is in a compressed configuration adjacent to the medical implant prior to delivery.

[0109] In some aspects, the technology described herein relates to methods in which a retention device is configured to expand adjacent to a medical implant after delivery.

[0110] In some aspects, the technology described herein relates to methods that further include collapsing the stasis device after injection of the contrast agent.

[0111] In some aspects, the technology described herein relates to methods that further include delivering a medical implant and a retention device through the outer sheath.

[0112] In some aspects, the technology described herein relates to methods further including retracting the outer sheath to remove the medical implant from the outer sheath, and further retracting the outer sheath to remove the retention device from the outer sheath.

[0113] In some aspects, the technology described herein relates to methods in which the retention device is expanded by removing the retention device from the outer sheath.

[0114] In some aspects, the technology described herein relates to a method in which the stasis device comprises a network of wires.

[0115] In some aspects, the technology described herein relates to methods where the network of wires comprises at least a partial conical shape.

[0116] In some aspects, the technology described herein relates to methods where the network of wires includes oval shaped wires and one or more curved wires.

[0117] In some aspects, the technology described herein relates to methods in which each curved wire of one or more curved wires is attached to an elliptical wire at a terminal end of the curved wire.

[0118] In some aspects, the technology described herein relates to methods in which one or more curved wires extend generally perpendicular to the oval shaped wire.

[0119] In some aspects, the technology described herein relates to methods in which a retention device is delivered through an outer sheath, and the elliptical wire is configured to expand to a larger diameter than the outer sheath.

[0120] In some aspects, the technology described herein relates to methods in which one or more curved wires are configured to extend outwardly from an inner catheter in response to removal from an outer sheath.

[0121] In some aspects, the technology described herein relates to methods in which a stagnation device is configured to surround at least a portion of an inner catheter.

[0122] In some aspects, the technology described herein relates to methods in which the retention device includes a cover that extends between the wires.

[0123] In some aspects, the technology described herein relates to methods where the cover is fluid-tight.

[0124] In some aspects, the technology described herein relates to methods where the cover is porous.

[0125] In some aspects, the technology described herein relates to methods where the retention device comprises an inflatable balloon.

[0126] In some aspects, the technology described herein relates to methods in which a retention device extends from the outer surface of the inner catheter.

[0127] In some aspects, the technology described herein relates to methods that further include delivering a retention device through the outer sheath, where the retention device extends from an outer surface of the outer sheath.

[0128] In some aspects, the technology described herein relates to methods where the stagnation device comprises a ring shape.

[0129] In some aspects, the technology described herein relates to methods in which the diameter of the stagnation device is greater than the width of the stagnation device.

[0130] In some aspects, the technology described herein relates to methods in which a retention device includes a tubular sheath having one or more expandable petals at an end portion of the tubular sheath.

[0131] In some aspects, the technology described herein relates to methods in which one or more expandable petals are attached to a pull wire configured to expand the one or more expandable petals.

[0132] In some aspects, the technology described herein relates to methods in which the retention device includes one or more webbing between one or more expandable petals.

[0133] In some aspects, the technology described herein relates to methods in which a stasis device includes one or more flaps configured to at least partially obstruct blood flow through an inner lumen of the stasis device.

[0134] In some aspects, the technology described herein relates to a method, wherein a medical implant includes a first anchoring arm and a delivery device is attached to the first anchoring arm.

[0135] In some aspects, the technology described herein relates to a delivery system including an expandable retention device configured to at least partially obstruct blood flow within the cardiac blood flow pathway and to compress following injection of a contrast agent into the cardiac blood flow pathway, an inner catheter configured to deliver the medical implant and retention device through the cardiac blood flow pathway and in proximity to a tissue wall of the heart, and a delivery device configured to manipulate at least a portion of the medical implant to a desired position relative to the tissue wall of the heart.

[0136] In some aspects, the technology described herein relates to a delivery system, wherein the delivery device is further configured to be detached from the medical implant following injection of a contrast agent into the blood flow pathways of the heart.

[0137] In some aspects, the technology described herein relates to a delivery system that further includes an outer sheath configured to at least partially encapsulate and store the retention device and the medical implant and to remove the medical implant and retention device from the outer sheath.

[0138] In some aspects, the technology described herein relates to a delivery system in which the retention device is expanded by removing the retention device from the outer sheath.

[0139] In some aspects, the technology described herein relates to a delivery system in which the retention device comprises a network of wires.

[0140] In some aspects, the technology described herein relates to a delivery system in which the network of wires comprises at least a partial conical shape.

[0141] In some aspects, the technology described herein relates to a delivery system in which the network of wires includes an oval wire and one or more curved wires.

[0142] In some aspects, the technology described herein relates to a delivery system in which each curved wire of one or more curved wires is attached to an oval-shaped wire at a terminal end of the curved wire.

[0143] In some aspects, the technology described herein relates to a delivery system in which one or more curved wires extend generally perpendicular to an oval-shaped wire.

[0144] In some aspects, the technology described herein relates to a delivery system in which a retention device is delivered through an outer sheath and an oval wire is configured to expand to a larger diameter than the outer sheath.

[0145] In some aspects, the technology described herein relates to a delivery system in which one or more curved wires are configured to extend outwardly from an inner catheter in response to removal from an outer sheath.

[0146] In some aspects, the technology described herein relates to a delivery system in which a retention device is configured to surround at least a portion of an inner catheter.

[0147] In some aspects, the technology described herein relates to a delivery system in which the retention device includes a cover that extends between the wires.

[0148] In some aspects, the technology described herein relates to a delivery system in which the cover is fluid-tight.

[0149] In some aspects, the technology described herein relates to a delivery system in which the cover is porous.

[0150] In some aspects, the technology described herein relates to a delivery system in which the retention device comprises an inflatable balloon.

[0151] In some aspects, the technology described herein relates to a delivery system in which a retention device extends from an outer surface of an inner catheter.

[0152] In some aspects, the technology described herein relates to a delivery system further comprising delivering a retention device through the outer sheath, the retention device extending from an outer surface of the outer sheath.

[0153] In some aspects, the technology described herein relates to a delivery system in which the retention device comprises a ring shape.

[0154] In some aspects, the technology described herein relates to a delivery system in which the diameter of the retention device is greater than the width of the retention device.

[0155] In some aspects, the technology described herein relates to a delivery system in which the retention device includes a tubular sheath having one or more expandable petals at an end portion of the tubular sheath.

[0156] In some aspects, the technology described herein relates to a delivery system in which one or more expandable petals are attached to a pull wire configured to expand the one or more expandable petals.

[0157] In some aspects, the technology described herein relates to a delivery system in which the retention device includes one or more webbing between one or more expandable petals.

[0158] In some aspects, the technology described herein relates to a delivery system in which the stasis device includes one or more flaps configured to at least partially obstruct blood flow through an inner lumen of the stasis device.

[0159] In some aspects, the technology described herein relates to a delivery system in which the medical implant includes a first anchoring arm and the delivery device is attached to the first anchoring arm.

[0160] In some aspects, the technology described herein relates to a delivery system that includes means for stagnating blood flow within a cardiac blood flow pathway, means for delivering a medical implant, means for stagnating through the cardiac blood flow pathway and adjacent to a tissue wall of the heart, and means for maneuvering at least a portion of the medical implant to a desired position relative to the tissue wall of the heart.

[0161] In some aspects, the technology described herein relates to a delivery system, the method for operating which is further configured to be detached from the medical implant following injection of a contrast agent into the blood flow pathways of the heart.

[0162] In some aspects, the technology described herein relates to a delivery system that further includes an outer sheath configured to at least partially encapsulate the retention means and the medical implant and store and remove the medical implant and retention means from the outer sheath.

[0163] In some aspects, the technology described herein relates to a delivery system in which the means for anchoring comprises a network of wires.

[0164] In some aspects, the technology described herein relates to a delivery system where the means for causing stagnation includes an inflatable balloon.

[0165] In some aspects, the technology described herein relates to a delivery system in which the means for causing retention includes a tubular sheath having one or more expandable petals at an end portion of the tubular sheath.

[0166] In some aspects, the technology described herein relates to a delivery system in which a medical implant includes a first anchoring arm, and a means for manipulating is attached to the first anchoring arm.

[0167] Further Examples Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a differing order, may be added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events are required to practice a process.

[0168] 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 of use, is intended to have its ordinary meaning and is generally intended to convey that a particular embodiment includes certain features, elements, and / or steps, but not other embodiments. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way by one or more embodiments, or that one or more embodiments necessarily include logic, with or without author input or prompting, for determining whether those features, elements, and / or steps are included or performed in any particular embodiment. 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, etc. Also, the term "or" is used in its inclusive sense (and not its exclusive sense), so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Conjunctive language such as "at least one of X, Y, and Z" is understood with the context as being 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.

[0169] In the above description of the embodiments, it should be understood that various features may be 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 inventive 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 may be applied to or used in conjunction 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 invention herein disclosed and claimed below should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the following claims.

[0170] It should be understood that 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 the element from other elements having a similar or identical name (other than 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 action that is performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0171] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the exemplary embodiments belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0172] Spatially relative terms such as "outside," "inside," "top," "bottom," "lower," "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 shown in the drawings. It should 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, if the 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 illustrative term "below" may include both a lower and upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may have different interpretations depending on the orientation.

[0173] Unless expressly stated otherwise, comparison and / or quantitative terms such as "less," "more," "greater than," and the like are intended to encompass the notion of equality. For example, "less" can mean "less than" as well as "less than" in the strict mathematical sense.

Claims

1. A delivery system, including an inner catheter (54) configured to deliver a cardiac shunt (150) and a stasis device (1500, 1900) to the coronary sinus (19) of the heart and proximate to the tissue wall (30) of the heart; a delivery device (162) configured to be attachable to and detachable from the cardiac shunt (150) and configured to manipulate at least a portion of the cardiac shunt (150) to a desired position relative to the tissue wall of the heart; an outer sheath (50) configured to at least partially enclose and store the stasis device (1500, 1700, 1900) and the cardiac shunt (150) and configured to remove the cardiac shunt (150) and the stasis device (1500, 1900) from the outer sheath (50), wherein the stasis device expands when removed from the outer sheath (50); and comprising, wherein the stasis device (1500, 1900) is configured to expand to at least partially inhibit blood flow within the coronary sinus (19) and to compress after injection of a contrast agent into the coronary sinus (19). A delivery system.

2. The delivery system according to claim 1, wherein the stasis device (1900) comprises a network of wires (1402a, 1402b; 1702a; 1706).

3. The delivery system according to claim 2, wherein the network of wires (1402a, 1402b; 1702a; 1706) has at least a partially conical shape.

4. The delivery system according to claim 2 or claim 3, wherein the network of wires (1402a, 1402b) comprises an elliptical wire (1402a) forming an elliptical opening within the stasis device and one or more curved wires (1402b) extending substantially perpendicular to the elliptical wire (1402a).

5. The delivery system according to claim 4, wherein each of the curved wires (1402b) is attached to the elliptical wire (1402a) at the end of the curved wire (1402b). **Claim 6**: The delivery system according to claim 4 or 5, wherein in response to removal from the outer sheath (50), the elliptical wire (1402a) is configured to expand to a diameter larger than the outer sheath (50), and the one or more curved wires (1402b) are configured to extend outwardly from the inner catheter (54). **Claim 7** The delivery system according to any one of claims 2 to 6, wherein the stalling device (1900) is configured to surround at least a portion of the inner catheter (54). **Claim 8** The delivery system according to any one of claims 2 to 7, wherein the stalling device (1900) comprises a cover (1405) extending between the wires. **Claim 9** The delivery system according to claim 8, wherein the cover (1405) is fluid-tight. **Claim 10** The delivery system according to claim 8, wherein the cover (1405) is porous. **Claim 11** The delivery system according to claim 1, wherein the stalling device includes an inflatable balloon (1500). **Claim 12** The delivery system according to claim 11, wherein the inflatable balloon (1500) extends from the outer surface of the inner catheter (54). **Claim 13** The delivery system according to claim 11 or 12, wherein the inflatable balloon (1500) is ring-shaped. **Claim 14** The delivery system according to any one of claims 11 to 13, wherein the diameter of the inflatable balloon (1500) is larger than the width of the stalling device.

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