Delivery of implants and contrast agents using a retention device.

Abstract

To provide one or more methods and / or apparatus for facilitating the placement and / or visualization of medical implantable devices. [Solution] The method includes delivering a medical implant and a delivery device to the tissue wall within the patient's heart. The delivery device may be attached to the medical implant. The method further includes operating the delivery device to position at least a portion of the medical implant in a desired position relative to the tissue wall, and delivering an expandable retention device adjacent to the medical implant. The expandable retention device is configured to obstruct blood flow at least partially. 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, folding the expandable retention device, and removing 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 on June 25, 2021, entitled "IMPLANT AND CONTRAST DELIVERY WITH STAGNATION DEVICE", the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] This disclosure generally relates to the field of medical implant devices.

Background Art

[0003] Various medical procedures involve the implantation of medical implant devices within the anatomical structures of the heart. Certain physiological parameters associated with such anatomical structures, such as fluid pressure, can affect the outlook of a patient's health.

Summary of the Invention

Means for Solving the Problems

[0004] One or more methods and / or devices for facilitating the placement and / or visualization of medical implant devices are described herein.

[0005] For purposes of summarizing this disclosure, certain aspects, advantages, and novel features are described. It should be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or a 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 shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the invention. In addition, various features of different disclosed embodiments may be combined to form additional embodiments which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondences between reference elements.

[0007] [Figure 1] Figure 1 illustrates several access routes for manipulating guidewires and catheters within and around the heart for deploying the compressible medical implant (e.g., frame) of this application. [Figure 2] Figure 2 illustrates an exemplary method for deploying the medical implant described herein, in which a guidewire and / or catheter is introduced into the coronary sinus via the superior vena cava (SVC) through the subclavian vein or jugular vein. [Figure 3] Figure 3 illustrates an exemplary shunt / anchor structure according to one or more embodiments. [Figure 4] Figure 4 illustrates, in one or more embodiments, how a guidewire can initially advance from the right atrium through its opening or pore into the coronary sinus. [Figure 5] Figure 5 illustrates the introduction of a shunt deployment or delivery catheter having a flexible, tapered distal tip that advances along a guidewire that remains bridging the tissue wall between the coronary sinus and the left atrium, according to one or more embodiments. [Figure 6] Figure 6 illustrates a delivery catheter advanced into the left atrium by puncturing the tissue wall in one or more embodiments, the passage of which is facilitated by puncture and expansion of the soft, tapered distal tip. [Figure 7] Figure 7 illustrates the initial development of a shunt in one or more embodiments, where a pair of distal flanges (e.g., anchor arms) expand within the left atrium and make contact with the tissue wall. [Figure 8] Figure 8 illustrates further development of an expandable shunt in one or more embodiments, just before a pair of proximal flanges expand within the coronary sinus and make contact with the wall. [Figure 9] Figure 9 is an enlarged view from the perspective of the coronary sinus to better illustrate the development of the proximal flange in one or more embodiments. [Figure 10] Figure 10 shows distal advancement of the first control rod or actuation rod from within the inner sheath in one or more embodiments. [Figure 11] Figure 11 then shows the release of the first proximal flange by the actuation rod, and thus, in one or more embodiments, the flange is made to elastically contact the tissue wall (or at least the luminal surface of the coronary sinus). [Figure 12] Figure 12 illustrates the storage of an operating rod within a side opening in one or more embodiments. [Figure 13] Figure 13 illustrates, in one or more embodiments, that the delivery catheter is stowed along the guidewire so that the shunt is fully deployed between the left atrium and the coronary sinus. [Figure 14] Figure 14 illustrates an exemplary stasis device, according to one or more embodiments, which may be configured to at least partially occlude blood flow paths within the heart. [Figure 15] Figure 15 illustrates another exemplary stasis device, which may be configured to at least partially occlude a blood flow pathway within the heart, according to one or more embodiments. [Figure 16] Figure 16 illustrates another exemplary stagnation device, which may be configured to at least partially occlude a blood flow pathway within the heart, according to one or more embodiments. [Figure 17A] Figure 17A illustrates another exemplary stasis device, which may be configured to at least partially obstruct blood flow within the cardiac blood flow pathway, according to one or more embodiments. [Figure 17B] Figure 17B illustrates another exemplary stasis device, which may be configured to at least partially obstruct blood flow within the cardiac blood flow pathway, according to one or more embodiments. [Figure 18-1] Figure 18-1 provides a flowchart 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 flowchart showing a process for arresting blood flow and / or visualizing one or more implants according to one or more embodiments. [Figure 18-3] FIG. 18-3 provides a flowchart showing a process for arresting blood flow and / or visualizing one or more implants according to one or more embodiments. [Figure 18-4] FIG. 18-4 provides a flowchart showing a process for arresting 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 a heart anatomical structure and a particular device / system corresponding to the operation of the process of FIG. 18-1 according to one or more embodiments of the present disclosure. [Figure 19-2] FIG. 19-2 is an image of a heart anatomical structure and a particular device / system corresponding to the operation of the process of FIG. 18-2 according to one or more embodiments of the present disclosure. [Figure 19-3] FIG. 19-3 is an image of a heart anatomical structure and a particular device / system corresponding to the operation of the process of FIG. 18-3 according to one or more embodiments of the present disclosure. [Figure 19-4] FIG. 19-4 is an image of a heart anatomical structure and a particular device / system corresponding to the operation of the process of FIG. 18-4 according to one or more embodiments of the present disclosure.

BEST MODE FOR CARRYING OUT THE INVENTION

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

[0009] While specific 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 uses, as well as their modifications and equivalents. Therefore, 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 action or operation of the method or process may be performed in any preferred order, and is not necessarily limited to any specific disclosed order. Various operations may be described sequentially as multiple separate operations in a manner that may be helpful in understanding a particular embodiment, but the order of description should not be interpreted as implying that these operations are order-dependent. In addition, structures, systems, and / or apparatus described herein may be embodied as integrated components or as separate components. For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other embodiments or advantages that may also be taught or suggested herein.

[0010] Certain reference numbers are reused across different figures of the set of figures of the present disclosure for convenience of apparatus, components, systems, features, and / or modules that may have similar features in one or more respects. However, for any of the embodiments disclosed herein, the reuse of common reference numbers in the drawings does not necessarily indicate that such features, apparatus, components, or modules are identical or similar. Rather, those skilled in the art can be informed by the context as to the extent to which the use of common reference numbers can imply similarity between the referenced subjects. The use of a particular reference number in the context of the description of a particular figure relates to the apparatus, component, aspect, feature, module, or system identified in that particular figure and is not necessarily related to any apparatus, component, aspect, feature, module, or system identified by the same reference number in another figure. Further, aspects of separate figures identified by common reference numbers can be interpreted as sharing characteristics or being completely independent of each other.

[0011] Certain standard anatomical terms of location are used herein, for the preferred embodiments, to refer to anatomical structures of an animal, namely a human. Certain spatially relative terms such as "outer", "inner", "upper", "lower", "under", "above", "vertical", "horizontal", "top", "bottom", and the like are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, and it is understood that these terms are used herein for ease of explanation to describe the positional relationship between the elements / structures illustrated in the drawings. It is understood that the spatially relative terms are intended to encompass different orientations of the element / structure 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, with respect to an alternative orientation of the subject patient or element / structure, represent a position below or beside such other element / structure, and vice versa.

[0012] This disclosure relates to systems, apparatus, and methods for the delivery and / or confirmation of delivery of various cardiac shunts and / or other medical implantable devices. In some implementations, this disclosure relates to blood flow occlusion devices that incorporate and / or are associated with cardiac shunts and / or other cardiac implantable devices. The term “associated” is used herein in accordance with its broad and ordinary meaning. For example, where a first feature, element, component, apparatus, or member is described as “associated” with a second feature, element, component, apparatus, or member, such description should be understood to indicate that the first feature, element, component, apparatus, or member is physically coupled, attached, connected, integrated, at least partially embedded, or otherwise physically related to the second feature, element, component, apparatus, or member, whether directly or indirectly. Specific embodiments relating to cardiac implantable devices are disclosed herein. However, while certain principles disclosed herein are particularly applicable to the anatomical structure of the heart, it should be understood that the devices relating to this disclosure may be implanted in or configured for implantation in any suitable or desirable anatomical structure.

[0013] Cardiac Physiology Heart failure is a common and potentially fatal condition affecting humans, and despite optimal treatment, suboptimal clinical outcomes often result in symptoms, morbidity, and / or death. Specifically, "diastolic heart failure" refers to a clinical syndrome of heart failure that occurs in the absence of major valve disease, while left ventricular systolic function (ejection fraction) is preserved. This condition is characterized by a stiff left ventricle with reduced adaptability and impaired relaxation, leading to increased end-diastolic pressure. Approximately one-third of heart failure patients have diastolic heart failure, and if present, very few treatments have been proven effective.

[0014] The symptoms of diastolic heart failure are, at least in most cases, due to increased 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 increased 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 subgroups of HF benefit from the reduction in LAP, which successively reduces left ventricular systolic preload and left ventricular end-diastolic pressure (LVEDP). It can also reduce pressure in the pulmonary circulation, lower the risk of pulmonary edema, improve respiration, and improve patient comfort.

[0015] The following includes a general description of the anatomical structure of the human heart, relating to the features and embodiments of the specific inventions disclosed herein and included to provide context for the specific aspects of this disclosure. In humans and other vertebrates, the heart is a hollow muscular organ with four pump chambers, and the left and right atria, as well as the left and right ventricles, each have their own unidirectional valves. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves, each attached to an annular portion having a dense fibrous ring that attaches directly or indirectly to the atrial and ventricular muscle fibers. Each annular portion defines a flow orifice. The four valves ensure that blood does not flow in the wrong direction during the cardiac cycle, i.e., that blood does not flow backward 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 through the mitral valve to the left atrium and then to the left ventricle, and finally from the left ventricle through the aortic valve into the aortic / arterial system.

[0016] Heart failure is a common and potentially fatal condition affecting humans, and despite optimal treatment, suboptimal clinical outcomes often result in symptoms, morbidity, and / or death. Specifically, "diastolic heart failure" refers to a clinical syndrome of heart failure that occurs in the absence of major valve disease, while left ventricular systolic function (ejection fraction) is preserved. This condition is characterized by a stiff left ventricle with reduced adaptability and impaired relaxation, leading to increased end-diastolic pressure. Approximately one-third of heart failure patients have diastolic heart failure, and if present, very few treatments have been proven effective.

[0017] The symptoms of diastolic heart failure are, at least in most cases, due to increased 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 increased 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 subgroups of HF benefit from the reduction in LAP, which successively reduces left ventricular systolic preload and left ventricular end-diastolic pressure (LVEDP). It can also reduce pressure in the pulmonary circulation, lower the risk of pulmonary edema, improve respiration, and improve patient comfort.

[0018] Pulmonary hypertension (PH) is defined as an increase in mean pressure in the main pulmonary arteries. While PH can result from many different causes, all have been shown to increase mortality. A fatal form of PH occurs in very small branches of the pulmonary arteries and is known as pulmonary arterial hypertension (PAH). In PAH, cells within the small arteries proliferate due to injury or disease, reducing the area within the arteries 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 arteries 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 cardiac chambers such as the pulmonary arteries.

[0019] This disclosure provides methods and apparatus for delivering implants, occlusion devices and / or similar devices to desired locations within the human body. The term “implant” is used herein in its plain and ordinary sense 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 “stagnation device,” “stagnation means,” and / or “means for stagnating blood flow” are used herein in their obvious and ordinary sense and may refer to any device that may be configured to occlude, slow, obstruct, block, stagnate, and / or otherwise affect the flow of blood and / or various other fluids (e.g., contrast agents) in one or more blood flow pathways of the heart. Implants and / or stagnation devices may be delivered via catheters (i.e., transcatheter) for various medical procedures and may generally have a robust and / or flexible structure. The term “catheter” is used herein in accordance with its broad and ordinary meaning and may include any tube, sheath, maneuverable sheath, maneuverable catheter, and / or any other type of elongated tubular delivery device having an inner lumen configured to slidably receive an instrument for purposes such as 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 made of a shape memory alloy (e.g., nitinol) and / or have a predefined shape and / or structure. The implant and / or retention devices described herein may be configured to be molded and / or compressed to fit within a catheter.

[0020] Several methods for delivering medical implants (e.g., shunt implants) may involve the injection of a contrast agent in or near the delivered implant. For example, the injection of a contrast agent may be performed after the distal and / or proximal arms of the implant have been fixed and / or positioned against the tissue wall. The injection of a contrast agent can provide a means of visualizing the area around the implant to determine whether the tissue wall has been properly captured by the distal and / or proximal arms of the implant. However, rapid blood flow around the implant, at least partially, can cause a rapid decrease in the concentration of the contrast agent, making it very difficult to identify the implant structure. Furthermore, this difficulty can be complicated by an inadequate fluoroscopy system.

[0021] In some cases, the auxiliary device may be used in conjunction with the delivery catheter to obstruct the flow within the bloodstream (for example, it may be delivered separately from the delivery catheter). However, the limited space within the bloodstream may make it difficult or impossible to accommodate the catheter and auxiliary device.

[0022] The anchor arm (e.g., flange) of a medical implant may be configured to extend into various regions of the heart, including the left atrium and / or coronary sinuses. Blood flow through these 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. Contrast agents may be visualized using X-rays and / or other systems, and / or 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 this disclosure provide methods and / or systems for at least partially stagnating and / or obstructing the flow of fluid through a blood flow pathway (e.g., coronary sinus) before, during, and / or after the injection of a contrast agent (e.g., an iodine-opaque material) at or near a delivered implant. When the flow is obstructed, the contrast agent remains at a high concentration, thereby providing a means for adequately visualizing and / or evaluating the positioning and / or configuration of the implant.

[0024] One or more retention devices may be configured to be delivered via a catheter / sheath (e.g., an atrial shunt delivery catheter (ASDC)) together with one or more implants (e.g., shunt implants) to an implant site (e.g., the tissue wall separating the coronary sinus from the left atrium). During delivery, the retention devices and / or 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., the distal arm of the implant) is exposed. The catheter / inner sheath may be retracted to allow the distal arm to seat against the first (e.g., left atrium) side of the tissue wall. The outer sheath may then be retracted until a second portion (e.g., the proximal arm) and / or the entire implant is exposed. An actuating rod and / or similar device attached to at least a portion of the implant (e.g., the proximal arm) may extend to position a portion of the implant against the second (e.g., coronary sinus) side of the tissue wall. The term “actuating rod” is used herein in accordance with its obvious and ordinary meaning and may include any delivery device, delivery arm, delivery rod, control arm / rod, and / or other device that is attached to and / or removed from a medical implant and / or moved and / or manipulated as necessary to facilitate the positioning 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, but additionally or alternatively, the stasis device may be configured to be manually expanded. The contrast agent may then be injected into or near the implant. In the expanded form, the stasis device may be configured to at least partially stagnate the flow of blood and / or contrast agent through the blood flow pathway. As a result, the stasis device may be configured to cause a higher concentration of contrast agent in the evaluation area, enabling the physician to make better judgments regarding the position and / or configuration of the implant.

[0025] Visualizing implanted devices is most effective when the contrast agent is located around the implanted device to which it has been delivered, and therefore it may be important to retain the contrast agent around the implanted device. However, blood flow through the openings to which the medical implant may be fixed can make it very difficult for the contrast agent to be contained. Therefore, to provide effective visualization of the medical implant, it may be beneficial to position a stasis device near and / or downstream of the medical implant. In some cases, by stasis of blood flow downstream of the implanted device, some blood and / or contrast agent may leak upward from the coronary sinus into the left atrium, accumulating along the left atrial wall and providing effective imaging of the distal anchor arm of the medical implant along the left atrial wall.

[0026] The stagnation device may, advantageously, be configured to be delivered and / or used in combination with one or more medical implants and / or simultaneously with one or more medical implants. For example, the stagnation device and the medical implant may be configured to be crimped onto the same inner sheath and / or enclosed by the same outer sheath. The stagnation device may, advantageously, have a relatively small external form and / or be configured to take a foldable form to accommodate medical implants and / or various delivery systems.

[0027] Figure 1 illustrates several access routes for manipulating the guidewire and catheter within and around the heart 1 for deploying the compressible medical implant (e.g., frame) of this application. For example, access can be made from above into the superior vena cava (SVC) 15, the right atrium (RA) 5 via either the subclavian or jugular vein, and from there into the coronary sinus (CS) 19. Alternatively, the access route may begin in the femoral vein and enter the heart 1 through the inferior vena cava (IVC) 14. Other access routes may also be used, each typically utilizing a percutaneous incision through which the 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] Figure 2 illustrates an exemplary method for deploying the medical implant 10 described herein, in which a guidewire and / or catheter 16 is introduced into the coronary sinus 19 through the SVC 15 via the subclavian or jugular vein. In some examples, the guidewire is used to provide a pathway, and then an introducer sheath (not shown) may be routed along the guidewire into the patient's vascular system, typically by the use of a dilator. Figure 2 shows a deployment catheter 16 extending from the SVC 15 into the coronary sinus 19 of the heart 1, passing through an introducer sheath that provides a hemostatic valve to prevent blood loss.

[0029] In one embodiment, the deployment catheter 16 may be about 30 cm in length, and the guidewire may be somewhat longer for ease of use. In some embodiments, the deployment catheter may function to form and prepare an opening in the wall of the left atrium 2, which will be used for delivery of a separate placement or delivery catheter for an 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 describe a catheter or introducer having one or both of these functions.

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

[0031] Several methods to reduce LAP involve utilizing an implant 10 between the left atrium 2 and the right atrium 5, through the interatrial septum between them. This is a convenient approach because the two structures are adjacent and transseptal access is a common method. However, there is a possibility that the embolus may move 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, mainly during individual events such as coughing, sneezing, Valsalva maneuver, or bowel movements. The anatomical location of the septum would naturally allow the embolus to move freely between the atria if implant 10 is present and the pressure gradient reverses. This can be mitigated by the valve or filter element of implant 10, but there is still a risk of the embolus crossing over.

[0032] Implanting in the coronary sinus 19 offers several different advantages, primarily for several reasons, including a much lower likelihood of an embolism being present in the coronary sinus 19. Firstly, the drainage of blood from the coronary vascular system into the right atrium 5 is already filtered blood, having just passed through capillaries. Secondly, the small opening of the coronary sinus 19 in the right atrium 5 is often partially covered by a false valve called the Thebesius valve. While not always present, the Thebesius valve is present in >60% of hearts and some studies show it acts as a natural "watchdog" against the coronary sinus to prevent embolisms from entering when right atrial pressure spikes. Thirdly, the pressure gradient between the coronary sinus 19 and the right atrium 5 from which it is drained is very low, making it more likely that a thrombus in the right atrium 5 will remain there. Fourthly, if an embolism were to enter the coronary sinus 19, there would be a much larger gradient between the right atrium 5 and the coronary vascular system than between the right atrium 5 and the left atrium 2. The most likely scenario is that the embolus will travel further down the coronary vascular system until the right atrial pressure returns to normal, and then the embolus returns directly to right atrium 5.

[0033] Several additional advantages of positioning the implant 10 between the left atrium 2 and the coronary sinus 19 include the fact that this anatomical structure is less mobile (more stable) than the diaphragm, and therefore retains the diaphragm for later transseptal access for alternative therapies and may have other potential therapeutic benefits. Diverting left atrial blood to the coronary sinus 19 may slightly increase sinus pressure. This may allow blood in the coronary vascular system to move more slowly through the heart, increasing perfusion and oxygen delivery, which may be more efficient and may also help the dying myocardium recover. Since 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, retaining transseptal access is also a significant advantage.

[0034] The implant 10 may also be positioned within the chamber and / or within a blood vessel, and / or between other ventricular chambers, such as between the pulmonary artery and the right atrium 5. It may be desirable for the implant 10 to be implanted within the wall of the pulmonary artery using a catheter that approaches from above and passes through the pulmonary artery using the deployment tool described herein. As described above, pulmonary hypertension (PH) is defined as an increase in mean pressure in the main pulmonary artery. If the pressure difference causes flow in that direction, blood flows from the pulmonary artery through the implant 10 to the right atrium 5, thereby reducing the pressure and minimizing damage to the pulmonary artery. The objective is to reduce pressure spikes in the pulmonary artery. The implant 10 may also extend from the pulmonary artery to other cardiac 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. Furthermore, in some embodiments, the implant 10 may have a variety of features and / or may be used in combination with devices having a variety of barriers for preventing, inhibiting, and / or containing tissue growth. The implant 10 may be configured to at least partially prevent, inhibit, reduce, contain, and / or otherwise alter tissue growth and / or tissue infiltration in and / or around the implant 10 and / or within openings in tissue walls. The implants 10 described herein may have a variety of features for simplifying and / or improving surgical delivery procedures. For example, the implant 10 may be at least partially flexible, compressible, and / or elastic so that it can be shaped and / or molded as needed and / or desired to fit into delivery catheters of various sizes and / or shapes.

[0036] Furthermore, the implant 10 may be configured to maintain various openings created in a tissue wall having varying sizes and / or shapes. The tissue wall 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, the openings may be created through the tissue wall, 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 fit at least partially within the openings. The openings may represent blood flow pathways between the first and second anatomical chambers. 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 implant Figure 3 illustrates exemplary shunt / anchor structures 150 (e.g., medical implants) according to one or more embodiments. The shunt structure 150 may represent embodiments of cardiac implants that may be configured to deliver in combination with one or more stasis devices according to specific 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 in a tissue wall, thereby forming a blood flow pathway between cardiac chambers or cardiac blood vessels separated by the tissue wall. For example, the shunt 150 may be configured to be embedded in the wall separating the coronary sinus from the left atrium. The central flow channel 166 may be partially formed 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 a hyperelastic support configured to be compressed and housed in a catheter (not shown), and then expanded to return to a relaxed shape as shown in Figure 3.

[0038] The formation of the shunt 150 using multiple interconnected struts forming cells between them may at least partially increase the flexibility of the shunt, thereby allowing 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 the tissue in an open puncture hole. The end walls 172a, 172b of the central flow channel 166 may connect the side walls 170a, 170b and extend between the distal and proximal flanges, or between the arms 152, 154 on each side. The side walls 170a, 170b and the end walls 172a, 172b together may define a tubular grid as shown. The end walls 172a, 172b may include thin struts 179 extending at a slight angle from the central flow axis of the shunt 150.

[0039] The illustrated shunt 150 includes supports defining a tubular or circular grid of open cells forming a central flow channel 166, although in some embodiments, the structures constituting the channel form a substantially continuous wall surface through at least a portion of the channel 166. In the illustrated embodiments, the inclination of the shunt structure 150 may facilitate not only the folding of the shunt into a delivery catheter (not shown) but also the expansion of the flanges / arms 152, 154 on both sides of the target tissue wall. The central flow channel 166 may remain essentially unchanged between the folded and expanded states of the shunt 150, whereas the flanges / arms 152, 154 may transition between alignment and misalignment with the angled flow channel.

[0040] The shunt 150 may include a leading flange or a terminal 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 include a terminal 160b. The first distal flange 152a and the second distal flange 152b may be completely discharged from the catheter and may extend generally in opposite directions. In some embodiments, the first distal flange 152a may be longer than the second distal flange 152b.

[0041] The flanges 152a and 152b may be configured to expand to contact a tissue wall (e.g., the left atrial side of the left atrial wall). The catheter can then be retracted until its distal tip is positioned within the coronary sinus, and then the proximal flange 154 can be deployed. One or more delivery devices (e.g., a first actuating rod and / or a second actuating rod) may be configured to engage with different positions on the expandable shunt 150 and control its discharge from the catheter. For example, the first actuating rod may engage with the leading flange or the end 164a of the first proximal flange 154a, while the second actuating rod may engage with the trailing flange or the 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 each other. The first actuating rod may continue to advance the end 164a of the first proximal flange 154a, while the second actuating rod may be stopped to halt the advancement of 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" section) opens gradually until it reaches a fully expanded state. The two actuating rods may carry a thin, elongated release rod, which may be retracted to disengage the rod from engagement with the proximal flanges 154a, 154b.

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

[0043] In some embodiments, the distal and proximal flanges / arms 152, 154, respectively, are curled outward from the end walls 172a, 172b and are configured to point substantially radially away from the central flow channel 166 in an expanded configuration. The expanded flanges / arms may serve to anchor the shunt 150 to the target tissue wall. Additional embodiments and features of shunt, implant, and / or anchor structures that may be used in combination with the stasis devices of embodiments of this disclosure 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 in its entirety by reference. While specific embodiments are disclosed herein in the context of shunt structures similar to those shown in Figure 3 and described above, it should be understood that any shunt structure or other implantable device used in combination with a stasis device according to embodiments of this disclosure may have any type, form, structure, configuration, and / or be used or configured for any purpose or function, whether shunt or otherwise.

[0044] Figures 4 to 13 are schematic diagrams of the process of creating a puncture hole through the wall of the coronary sinus and placing a shunt between the coronary sinus and the left atrium, with the posterior view facing downwards and looking down at a portion of the heart.

[0045] As shown in Figure 4, the guidewire 36 may first advance from the right atrium 5 through its small opening or opening into the coronary sinus 19. Then, the puncture catheter 22 (e.g., an internal sheath) advances 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 specific vascular pathway (e.g., a jugular vein or a subclavian vein) and / or may have a hemostatic valve therein. While holding the introducer sheath in a fixed position, the surgeon can manipulate the puncture catheter 22 to the implant site.

[0046] Figure 5 shows the deployment of a shunt or delivery catheter 50 having a soft, tapered distal tip 52 that advances along a guidewire 36 that remains bridging the tissue wall 30 between the coronary sinus and the left atrium 2. Figure 6 illustrates the delivery catheter 50 advanced into the left atrium by puncturing the tissue wall 30, and this passage is facilitated by the puncture 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 position of the expandable shunt 150 within it, just proximal to the distal tip 52. The expandable shunt 150 is shown in a folded, generally tubular configuration that facilitates passage through the lumen of the catheter 50. The working rod extending through the lumen and / or connected to the expandable shunt 150 is not shown in some of these figures for clarity, but will be described below.

[0047] Figure 7 depicts the initial deployment of the shunt 150, where a pair of distal flanges 152 (e.g., anchor arms) expand within the left atrium 2 and make contact with the tissue wall 30. This expansion is initiated by the retraction of the outer sheath of the delivery catheter 50 into the inner sheath / catheter 54. The shunt 150 is located in the annular space between the inner sheath 54 and the outer sheath 50. The inner sheath 54 passes through the central passage of the shunt 150. Typically, the shunt 150 folds (curls) between the two sheaths into a generally tubular configuration, as shown in Figures 7 and 8, with the flanges straightened and with their spring-open flanges. As described 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 which would form an annular flange. A radiopaque marker on flange 152 may be provided to facilitate immediate positioning within the left atrium.

[0048] Figure 8 illustrates the further deployment of the expandable shunt 150, just before the pair of proximal flanges 154 expand within the coronary sinus 19 and make contact with the wall 30. More specifically, the physician retracts the inner sheath 54 and the entire shunt 150 until the two distal flanges 152 make contact with the tissue wall 30. This can be felt by tactile feedback or by reconfirming the position of the distal flanges 152 by visualization using radiopaque material. The outer sheath 50 is also shown retracted further proximal to expose the pair of proximal flanges 154. At this stage in the deployment of the shunt 150, the proximal flanges 154 are held in place by the working rod to prevent them from expanding within the coronary sinus 19.

[0049] Figure 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 medial sheath 54 houses the distal flange 152 so that it engages closely with the tissue wall 30 on the left atrial side. The proximal flange 154 remains generally aligned and constrained with the medial sheath 54.

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

[0051] Figure 11 then shows the release of the first proximal flange 154a by the actuating rod 162, thus allowing the flange to elastically contact the tissue wall 30 (or at least the luminal surface of the coronary sinus). Next, the physician causes the actuating rod 162 to retract into the lateral opening, as shown in Figure 12. Subsequently, a second control rod or actuating rod (not shown) can release the trailing flange or second proximal flange 154b, which also allows 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 passage of the shunt. The opposing leading flanges 152a, 154a, as well as the opposing trailing flanges 152b, 154b, form a clamping pair of flanges. As described, the flange clamp pair applies a small compressive force to the tissue wall 30 and holds the shunt 150 in place, but the gap separating the flange clamp pair should preferably be calibrated to avoid excessive tightening or necrosis of the tissue.

[0052] To ensure that the shunt 150 is fully deployed between the left atrium and the coronary sinus, the delivery catheter 50 is shown as being stowed along the guidewire 36 in Figure 13. Next, the guidewire 36 is also stowed.

[0053] Shunting to the coronary sinuses offers several different advantages, primarily for several reasons, that emboli are far less likely to be present in the coronary sinuses. Firstly, the drainage of blood from the coronary vascular system into the right atrium is filtered blood, having just passed through capillaries. Secondly, the opening of the coronary sinuses in the right atrium is often partially covered by a false valve called the Thebesius valve. While not always present, the Thebesius valve is present in >60% of hearts and some studies show it acts as a natural "watchdog" against the coronary sinuses to prevent emboli from entering when right atrial pressure spikes. Thirdly, the pressure gradient between the coronary sinuses and the right atrium from which it is drained is very low, making it more likely that a thrombus in the right atrium will remain there. Fourthly, in events where an embolus enters the coronary sinuses, there will be a much larger gradient between the right atrium and the coronary vascular system than between the right and left atria. The most likely scenario is that the embolus will travel further down the coronary vascular system until the right atrial pressure returns to normal, and then the embolus returns directly to the right atrium.

[0054] Several additional advantages of positioning a shunt between the left atrium and the coronary sinus are that this anatomical structure is less mobile (more stable) than the diaphragm, and therefore retains the diaphragm for later transseptal access for alternative therapies and may have other potential therapeutic benefits. By diverting left atrial blood to the coronary sinus, sinus pressure may increase by a small amount. This may allow blood in the coronary vascular system to move more slowly through the heart, increasing perfusion and oxygen delivery, which may be more efficient and may also help the dying myocardium recover. One device designed to do this is the Neovasc Reducer. HF patients often have many other comorbidities such as atrial fibrillation (AF) and mitral regurgitation (MR), and retaining transseptal access is also a significant advantage, as some therapies to treat these conditions require a transseptal approach.

[0055] Shunt 150 may also be positioned between other ventricular chambers, such as between the pulmonary artery and the right atrium. It is desirable that shunt 150 be implanted within the wall of the pulmonary artery using a catheter that approaches from above and passes through the pulmonary artery using the deployment tool described herein. As described above, pulmonary hypertension (PH) is defined as an increase in mean pressure in the main pulmonary artery. If the pressure difference causes flow in that direction, blood flows from the pulmonary artery through shunt 150 to the right atrium, thereby reducing the pressure and minimizing damage to the pulmonary artery. The objective is to reduce pressure spikes in the pulmonary artery. Shunt 150 may also extend from the pulmonary artery to other cardiac chambers (e.g., the left atrium) and / or blood vessels. Although not preferred and not shown, shunt 150 may further include a one-way valve to prevent backflow, or a check valve to allow blood to pass only above a specified pressure.

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

[0057] In some embodiments, the stabling device may comprise infrastructure and / or a skeleton that may include one or more cords 1402. The term “cord” is used herein in accordance with its clear and ordinary meaning and may refer to a line of any rigid and / or flexible material, and may include wires, sutures, strings, bars, and / or rods. The cord may consist of one or more materials, which may include metal (e.g., Nitinol) and / or plastic. One or more cords 1402 may generally have a flexible structure. For example, the cord 1402 may consist at least partially of a shape memory alloy (e.g., Nitinol) and / or other material configured to bend and / or bend in any other way in response to an external force. In some embodiments, one or more cords 1402 may be shaped into a desired form. In the embodiment shown in Figure 14, the stabling device may comprise a first cord 1402a that may be elliptical in shape and / or form a partial ellipse. The first code 1402a may be configured to connect with the end portion of another code 1402 (e.g., a second code 1402b), which may be configured to extend generally longitudinally along the inner sheath 54.

[0058] One or more cords 1402 (e.g., a second cord 1402b) may have a generally linear and / or curved form. For example, the second cord 1402b and / or other cords 1402 may be configured to extend from the inner sheath 54 and / or away from the longitudinal axis of the inner sheath 54 and / or the stabling device. In this way, the stabling device may have a generally conical shape (e.g., at least partially conical) and / or umbrella shape, and the first cord 1402a forms an elliptical opening within the stabling device. The second cord 1402b and / or other cords may extend generally longitudinally along the longitudinal axis of the inner sheath 54 and / or the stabling device, and / or the second cord 1402b and / or other cords may be attached to the first cord 1402a at the end of the second cord 1402b and / or other cords. The second code 1402b and / or other codes may generally extend perpendicularly to the first code 1402a.

[0059] The diameter of the elliptical opening formed by the first code 1402a may be larger than the diameter of the outer sheath 50 and / or the diameter of the stasis device in other parts of the stasis device. In some embodiments, the stasis device and / or the first code 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 way, at least a portion of the stasis device including the first code 1402a may be configured to expand until it contacts the wall of the blood flow pathway, thereby effectively occluding at least a portion of the blood flow pathway.

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

[0061] In some embodiments, the stasis device may comprise one or more covers 1405 (e.g., skirts) configured to form at least a partial barrier around the outer portion of the stasis device. In some embodiments, the covers 1405 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 covers 1405 and / or to allow some blood flow through the covers 1405. The covers 1405 may be composed of any suitable material, which may include polytetrafluoroethylene (PTFE) and / or similar materials.

[0062] Although a stasis device including a first code 1402a is shown, the stasis device does not necessarily have to include an elliptical code at the end of the stasis device. For example, one or more longitudinally extending code (e.g., a second code 1402b and / or additional code 1402) may be configured to extend outward individually and / or independently and / or to press against the wall of the blood flow pathway.

[0063] In some embodiments, the cover 1405 may be configured to have at least a partially folded form while the stagnation device is in a compressed form within the outer sheath 50. As the stagnation device expands, the cover 1405 may also be configured to expand so that the folded portion of the cover is stretched out and the creases are removed.

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

[0065] The retention device 1500 may generally have a small profile to allow it to be used in combination with various other devices and / or implants. For example, the retention device 1500 may have a minimum width and / or 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] Figure 16 illustrates another exemplary stasis device 1600 comprising an inflatable and / or expandable balloon, which may be configured to at least partially occlude a blood flow pathway within the heart, according to one or more embodiments. The stasis device 1600 may be configured to be inflated using air and / or fluid to form an expanded shape. In some embodiments, the stasis device 1600 may be configured to form a ring-shaped extension around at least a portion of the outer sheath 50. For example, the stasis device 1600 may be attached to the outer surface of the outer sheath 50. The stasis device 1600 may be configured to have a reduced shape during delivery. Upon and / or after delivery to the target location, the stasis device 1600 may be inflated and expand in all or part of the directions around the outer sheath 50. The stasis device 1600 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 stagnation device 1600 may be further configured to deflate after inflation. For example, the stagnation device 1600 may be inflated only temporarily to at least partially occlude the blood flow pathway. After the application of a contrast agent to the blood flow for visualization, the stagnation device 1600 may deflate to allow normal blood flow through the blood flow pathway.

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

[0068] Figures 17A and 17B illustrate another exemplary stasis device 1700, which may be configured to at least partially occlude blood flow in the cardiac blood flow pathway, according to one or more embodiments. Figure 17A shows a compressed form of the stasis device 1700, and Figure 17B shows an extended form of the stasis device 1700. The stasis device 1700 may be configured to be used as an outer sheath and / or to extend at least partially along an inner sheath 54. The stasis device 1700 may have a generally tubular shape to approximate the tubular shape of the inner sheath 54.

[0069] At the end portion of the stasis device 1700, the stasis 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 stasis device 1700. The one or more petals 1706 may at least partially overlap each other while in the compressed form shown in Figure 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 attached to and engaged with and / or actuated by a first petal 1706a of the stasis device 1700. For example, the first wire 1702a may be configured to extend along and / or within the stasis device 1700 and / or be accessible to a surgeon. The first wire 1702a may be configured to be pulled backward (for example, away from the end portion of the stowage device 1700) to apply a backward 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 Figure 17B, the petal 1706 may be configured to be pulled backward to increase the diameter of the stowage device 1700 at the end portion of the stowage 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 generally have a flexible structure and / or be configured to stretch as the petals 1706 expand. In some embodiments, the webbings 1707 may be configured to fold (e.g., fold) when the stasis device 1700 is in an unexpanded form and / or to expand (e.g., spread) when the stasis device 1700 is in an expanded form. The webbings 1707 may be configured to close the gap between the petals 1706 to prevent fluid from leaking between the petals 1706.

[0071] The stagnation device 1700 may be configured to at least partially prevent fluid (e.g., blood and / or contrast agent) from leaking into the stagnation device 1700. In some embodiments, the stagnation device 1700 may include one or more closure plugs configured to be activated in response to expansion of the stagnation device 1700. For example, the stagnation device 1700 may include a flap configured to extend over at least a portion of the inner lumen of the stagnation device in response to separation and / or expansion of the petal 1706. The flap may represent a barrier that prevents fluid flow beyond the flap, allowing for effective flow stagnation at or near the distal end of the stagnation device 1700. In response to the stagnation device 1700 returning to its unexpanded form, the flap may be configured to compress and / or press against the inner wall of the stagnation device 1700.

[0072] Flow stagnation process Figures 18-1, 18-2, 18-3, and 18-4 provide flowcharts illustrating process 1800 for stagnating blood flow and / or visualizing one or more implants in one or more embodiments. Figures 19-1, 19-2, 19-3, and 19-4 are images of cardiac anatomical structures and specific devices / systems corresponding to the operation of process 1800 in Figures 18-1, 18-2, 18-3, and 18-4 in one or more embodiments of the present disclosure.

[0073] In block 1802, process 1800 involves delivering a distal anchor arm 152 (e.g., a flange), including a first distal arm 152a and / or a second distal arm of the implantation device, through an opening in the tissue wall 30 and / or distal to the tissue wall 30, as shown in image 1902 of Figure 19. While a specific embodiment of the delivery system is shown in Figure 19-1, it should be understood that implantation devices according to aspects of this disclosure may be delivered and / or implanted using any suitable or preferred delivery system and / or delivery system components. Furthermore, while a shunt implantation device is shown, the steps of process 1800 in Figure 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 located within the outer sheath 50 (e.g., the outer catheter) during one or more parts of process 1800. In some embodiments, the shunt structure may be at least partially located around the inner catheter 54, and the shunt structure may be at least partially located within the outer sheath 50 during one or more parts of process 1800. For example, the inner catheter 54 may be located within the barrel portion of the shunt structure, as shown.

[0075] The implantable 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 operating 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 the 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 one or more retention devices may be configured to be delivered via an inner catheter 54 and / or an 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 by a first amount may expose the medical implant (but not the retention device), and / or retracting the outer sheath 50 further by 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 is at least partially positioned within it. For example, the guidewire may run within the sheath and / or axial region of the inner catheter 54, such as within the inner catheter 54 as shown. The delivery system may be configured to advance along 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 which may be associated with a sheath 50, a catheter 54, and / or the distal end of the delivery system. In some implementations, the nose cone feature 52 may be used to expand an opening in the tissue wall through which an implantable device is implanted or through which the delivery system is advanced. The nose cone feature 52 may facilitate the advancement of the distal end of the delivery system through the patient's tortuous anatomical structure and / or using the 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 a plurality of flap-like forms which are urged / spread apart as the implantable device and / or any part thereof, the internal catheter 54, or other device advances through it.

[0078] The outer sheath 50 may be used to transport the implantation device and / or one or more retention devices to the target implantation site. That is, the implantation device and / or retention devices may be advanced at least partially within the lumen of the outer sheath 50 to the target implantation site so that the implantation device and / or retention devices are at least partially held and / or fixed within the 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 cardiac anatomical structures using a delivery system may be performed by following one or more procedures or steps to position a guidewire and create and / or expand an opening between the left atrium and coronary sinus of the patient's heart, but the details 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 preferred or desired procedure. For example, various access routes may be utilized when manipulating guidewires and catheters within and around the heart to deploy one or more implants and / or stasis 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 guidewires and catheters are inserted into the vascular system, usually through a sealed introducer, and from there the system may be designed or configured to allow a physician to control the distal end of the device from outside the body.

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

[0082] The guidewire may be positioned to run through the opening in the tissue wall 30 before the nose cone 52 penetrates the opening. The opening may be initially formed using a needle (not shown) associated with the delivery system or another delivery system implemented before block 1802. In some implementations, the nose cone feature 52 may be used to at least partially expand the opening, although the opening may have been previously expanded using a balloon expander or other device.

[0083] In block 1804, process 1800 involves extending, advancing, and / or operating an actuating rod 162 attached to the first proximal arm 154a, as shown in image 1904 of Figure 19, to attach and / or fix at least a portion of a medical implant (e.g., the first proximal arm 154a) to the proximal side of the tissue wall 30. In some embodiments, the actuating rod 162 may be manually and / or electronically controlled and / or operated to control the advancement of one or more portions of the implantation device. Although only a single actuating rod 162 is shown, additional actuating rods 162 may be used for the 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 can pull the first anchor arm 154a back and attempt to attach the first anchor arm 154a to the tissue wall again. However, after the actuation rod 162 and / or additional actuation rods have been removed from the first anchor arm 154a and / or additional anchor arms, it may be difficult or impossible to re-engage and / or reposition the anchor arm 154. Therefore, before disengaging the actuation rod 162 from the first anchor arm 154a, contrast agent may be injected and / or one or more stabilization devices may be activated to help determine the correct positioning of the implantation device.

[0085] In block 1806, process 1800 involves at least partially retracting the outer sheath 50 to expose at least a portion of the expandable stasis device 1900 adjacent to at least a portion of the medical implant, as shown in image 1906 of Figure 19. In some embodiments, the stasis device 1900 may be configured to at least partially occlude, inhibit, stagnate, and / or obstruct blood flow through the coronary sinus 19 and / or other blood flow pathways. The stasis device 1900 may have any of various forms, including a network of wires forming a wire "umbrella" shape as shown in Figure 19, one or more inflatable balloons, and / or expandable tubes / sheaths. In some embodiments, the stasis device 1900 may have a generally conical shape, with a circular base and / or opening of the stasis device 1900 located adjacent to the medical implant. The stasis device 1900 may be configured to take a compressed form while being crimped on the inner sheath 54 and / or at least partially enclosed by the outer sheath 50. In response to the outer sheath 50 being retracted and at least a portion of the stasis device 1900 being exposed, the stasis device 1900 and / or the exposed portion of the stasis device 1900 may be configured to expand at least partially to form an increased diameter. In some embodiments, the stasis device 1900 may be configured to expand at least partially manually. For example, the stasis device 1900 may expand by inflation and / or by acting on and / or pulling one or more wires attached to at least a portion of the stasis 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-sealed and / or configured to completely and / or significantly stagnate blood flow. However, total blood flow stagnation is not required, and the stasis device 1900 may be at least partially porous to allow some blood flow to pass through the stasis device 1900.

[0087] If the stasis device 1900 is in an extended form, the contrast agent may be injected into the coronary sinus 19. In some embodiments, the contrast agent may be configured to be injected through a lateral opening 159 of the inner sheath 54. The lateral 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 stasis device 1900, and / or approximately below the opening and / or below the implantation device. Due to the stasis of the flow provided by the stasis device 1900, the contrast agent around the implantation device may move relatively slowly and / or remain at a relatively high concentration to allow for effective visualization of the implantation device.

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

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

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

[0091] Additional aspects and features of the process for delivering a shunt structure, which may be delivered and / or utilized in combination with a stasis device, according to embodiments of this 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," which is expressly incorporated herein in its entirety by reference. Although the implantation device is shown in the left atrial / coronary sinus wall, the implantation device may be positioned between other cardiac chambers, such as between the left and right atria.

[0092] Some implementations of the present disclosure relate to methods for 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 operating 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, folding the expandable retention device, and removing the delivery device from the medical implant.

[0093] The method may further include delivering a medical implant and an expandable retention device through a 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, when the expandable stagnation device is removed from the first catheter, the expandable stagnation device expands.

[0095] An expandable stasis device may comprise a network of wires configured to expand into a cone shape. In some embodiments, the expandable stasis device comprises an inflatable balloon.

[0096] In some embodiments, the method further includes delivering an expandable stagnation device via an inner sheath. The expandable stagnation device may extend from the inner sheath. The method may further include delivering an expandable stagnation device via an inner sheath and an outer sheath, with the expandable stagnation device extending from the outer sheath.

[0097] An expandable stag device may comprise a tubular sheath having one or more expandable petals at the end of the expandable stag device. In some embodiments, one or more expandable petals are attached to a pull wire configured to expand one or more expandable petals.

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

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

[0100] In some implementations of the present disclosure, the delivery system comprises: an expandable stagnation device configured to at least partially obstruct blood flow within the cardiac blood flow pathway and to compress after injection of contrast agent into the cardiac blood flow pathway; an inner sheath configured to deliver a medical implant and the expandable stagnation device through the cardiac blood flow pathway and in close proximity to the cardiac tissue wall; and a delivery device attached to the medical implant and configured to manipulate at least a portion of the medical implant to a desired position relative to the cardiac tissue wall and to be removed from the medical implant after injection of contrast agent into the cardiac blood flow pathway.

[0101] The delivery system may further comprise an outer sheath configured to at least partially enclose and house an expandable stowage device and a medical implant, and to allow the medical implant and the expandable stowage device to be removed from the outer sheath.

[0102] In some embodiments, the expandable stagnation device is expanded by removing it from the outer sheath. The expandable stagnation device may comprise a network of wires configured to expand in a conical shape.

[0103] The expandable stagnation device may be equipped with an inflatable balloon. In some embodiments, the expandable stagnation device extends from an inner sheath.

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

[0105] In some embodiments, the techniques described herein relate to a method comprising: delivering a medical implant and a delivery device to a tissue wall in a patient's heart via an internal catheter; operating the delivery device to position at least a portion of the medical implant in a desired location relative to the tissue wall; delivering a retention device adjacent to the medical implant, wherein the retention device is 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 embodiments, the techniques described herein relate to a method for attaching a delivery device to a medical implant.

[0107] In some embodiments, the techniques described herein further include removing a delivery device from a medical implant after the injection of a contrast agent.

[0108] In some embodiments, the techniques described herein relate to a method by which a stasis device is in a compressed form in close proximity to a medical implant prior to delivery.

[0109] In some embodiments, the techniques described herein relate to a method in which a stasis device is configured to expand adjacent to a medical implant after delivery.

[0110] In some embodiments, the techniques described herein further include a method for folding a retention device after the injection of a contrast agent.

[0111] In some embodiments, the techniques described herein further include a method for delivering medical implants and retention devices via an outer sheath.

[0112] In some embodiments, the technique described herein further includes a method for retracting an outer sheath to remove a medical implant from the outer sheath, and for further retracting the outer sheath to remove a retention device from the outer sheath.

[0113] In some embodiments, the techniques described herein relate to a method for expanding a stagnation device by removing the stagnation device from the outer sheath.

[0114] In some embodiments, the technology described herein relates to a method by which a stagnant device includes a network of wires.

[0115] In some embodiments, the techniques described herein relate to a method by which a network of wires includes at least a partially conical shape.

[0116] In some embodiments, the techniques described herein relate to a method by which a wire network includes elliptical wires and one or more curved wires.

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

[0118] In some embodiments, the techniques described herein relate to a method by which one or more curved wires extend generally perpendicular to an elliptical wire.

[0119] In some embodiments, the techniques described herein relate to a method by which a stagnant device is delivered via an outer sheath and an elliptical wire is configured to expand to a diameter larger than that of the outer sheath.

[0120] In some embodiments, the techniques described herein relate to a method by which one or more curved wires are configured to extend outward from an inner catheter in response to removal from an outer sheath.

[0121] In some embodiments, the techniques described herein relate to a method by which a retention device is configured to surround at least a portion of an internal catheter.

[0122] In some embodiments, the techniques described herein relate to a method by which a stagnant device includes a cover that extends between wires.

[0123] In some embodiments, the techniques described herein relate to a method for which the cover is fluid-sealed.

[0124] In some embodiments, the techniques described herein relate to methods for having a porous cover.

[0125] In some embodiments, the techniques described herein relate to a method in which the stasis device includes an inflatable balloon.

[0126] In some embodiments, the techniques described herein relate to a method in which the retention device extends from the outer surface of the inner catheter.

[0127] In some embodiments, the techniques described herein further include delivering a stasis device via an outer sheath, wherein the stasis device extends from the outer surface of the outer sheath.

[0128] In some embodiments, the technology described herein relates to a method by which the stagnant device includes a ring shape.

[0129] In some embodiments, the techniques described herein relate to a method in which the diameter of the stagnant device is greater than the width of the stagnant device.

[0130] In some embodiments, the technology described herein relates to a method for a stasis device comprising a tubular sheath having one or more expandable petals at the end portion of the tubular sheath.

[0131] In some embodiments, the technology described herein relates to a method by which one or more expandable pedals are attached to a pull wire configured to expand one or more expandable pedals.

[0132] In some embodiments, the technology described herein relates to a method by which a stabling device includes one or more webbings between one or more expandable pedals.

[0133] In some embodiments, the techniques described herein relate to a method by which a stasis device includes one or more flaps configured to at least partially obstruct blood flow through the inner lumen of the stasis device.

[0134] In some embodiments, the technology described herein relates to a method by which a medical implant comprises a first anchor arm and a delivery device is attached to the first anchor arm.

[0135] In some embodiments, the technology described herein relates to a delivery system comprising: an expandable stagnation device configured to at least partially obstruct blood flow within the cardiac blood flow pathway and to compress after injection of a contrast agent into the cardiac blood flow pathway; an internal catheter configured to deliver a medical implant and the stagnation device through the cardiac blood flow pathway and in close proximity to the cardiac tissue wall; and a delivery device configured to manipulate at least a portion of the medical implant to a desired position relative to the cardiac tissue wall.

[0136] In some embodiments, the technology described herein relates to a delivery system in which the delivery device is further configured to be removed from a medical implant after the injection of a contrast agent into the cardiac blood flow pathway.

[0137] In some embodiments, the technology described herein further comprises a delivery system comprising an outer sheath configured to at least partially enclose and house a stowage device and a medical implant, and to allow the medical implant and the stowage device to be removed from the outer sheath.

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

[0139] In some embodiments, the technology described herein relates to a delivery system in which the stagnant device includes a network of wires.

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

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

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

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

[0144] In some embodiments, the technology described herein relates to a delivery system in which a stagnant device is delivered via an outer sheath and an elliptical wire is configured to expand to a diameter larger than that of the outer sheath.

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

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

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

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

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

[0150] In some embodiments, the technology described herein relates to a delivery system in which the stasis device includes an inflatable balloon.

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

[0152] In some embodiments, the technology described herein further includes delivering a stasis device via an outer sheath, wherein the stasis device extends from the outer surface of the outer sheath, relating to a delivery system.

[0153] In some embodiments, the technology described herein relates to a delivery system in which the stagnant device includes a ring shape.

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

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

[0156] In some embodiments, 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 one or more expandable petals.

[0157] In some embodiments, the technology described herein relates to a delivery system in which the stabling device includes one or more webbings between one or more expandable pedals.

[0158] In some embodiments, 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 the inner lumen of the stasis device.

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

[0160] In some embodiments, the technology described herein relates to a delivery system comprising means for stagnating blood flow within a cardiac blood flow pathway, means for delivering a medical implant, means for stagnating through a cardiac blood flow pathway and in close proximity to the cardiac tissue wall, and means for manipulating at least a portion of the medical implant to a desired position relative to the cardiac tissue wall.

[0161] In some embodiments, the technology described herein relates to a delivery system in which the method for operation is further configured to be removed from a medical implant after the injection of a contrast agent into the cardiac blood flow pathway.

[0162] In some embodiments, the technology described herein further comprises a delivery system comprising an outer sheath configured to at least partially enclose and house a stagnant means and a medical implant, and to allow the medical implant and the stagnant means to be removed from the outer sheath.

[0163] In some embodiments, the technology described herein relates to a delivery system in which the means of stagnating includes a network of wires.

[0164] In some embodiments, the technology described herein relates to a delivery system in which the means for stagnating includes an inflatable balloon.

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

[0166] In some embodiments, the technology described herein relates to a delivery system in which a medical implant comprises a first anchor arm, and means for operating the first anchor arm is attached to the first anchor arm.

[0167] Additional examples Depending on the embodiment, any particular action, event, or function of any of the processes or algorithms described herein may be performed in a different order, added, combined, or completely excluded. Therefore, in any particular embodiment, not all described actions or events are necessary for the practice of the process.

[0168] In particular, conditional language used herein, such as “can,” “could,” “might,” “may,” and “e.g.,” is intended in its ordinary sense unless otherwise stated or understood differently in the context in which it is used, and is generally intended to convey that certain features, elements, and / or steps are included in certain embodiments but not in others. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are required in any way in one or more embodiments, or that one or more embodiments necessarily include, with or without input or prompting by the author, logic for determining whether these features, elements, and / or steps are included or performed in any particular embodiment. Terms such as “comprising,” “including,” and “having” are synonymous and are used in their ordinary sense, comprehensively and non-restrictively, without precluding additional elements, features, actions, or behaviors. Furthermore, the term "or" is used in its inclusive sense (and not its exclusive sense), and therefore, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Connecting phrases such as "at least one of X, Y, and Z" are generally understood in context to be used to convey that an item, term, element, etc., may be one of X, Y, or Z, unless otherwise specified. Thus, such connecting phrases are not generally intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z, respectively.

[0169] In the above descriptions of the embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various embodiments of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than expressly described in that claim. Furthermore, any components, features, or steps illustrated and / or described in a particular embodiment of this specification may be applied to or used in conjunction with any other embodiment. Moreover, there are no components, features, steps, or groups of components, features, or steps that are necessarily required or essential to each embodiment. Accordingly, the scope of the invention of this specification disclosed and claimed below should not be limited by the particular embodiments described above, and 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 any physical characteristics or order. Therefore, when used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements such as structure, components, and actions do not necessarily indicate the priority or order of the element relative to any other element, but rather may schematically distinguish the element from other elements having similar or identical names (other than the use of sequential terms). In addition, when used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, actions performed "on the basis" of a condition or event may also be performed on the basis of one or more other conditions or events not explicitly listed.

[0171] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as those generally 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 the meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0172] The spatially relative terms “outside,” “inside,” “top,” “bottom,” “down,” “up,” “vertical,” “horizontal,” and similar terms may be used herein to facilitate explanation and to describe the relationship between one element or component and another, 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 drawing is turned over, a device positioned “below” or “directly below” another device may be positioned “above” the other device. Thus, the illustrative term “below” may include both lower and upper positions. The device may also be oriented in other directions, and therefore, the spatially relative terms may have different interpretations depending on the orientation.

[0173] Unless otherwise explicitly stated, comparative and / or quantitative terms such as "less," "more," and "greater" are intended to encompass the concept of equality. For example, "less" can mean not only "less" in the strict mathematical sense, but also "less than or equal to."

Claims

[Claim 1] A delivery system, A stagnation device configured to expand and at least partially obstruct blood flow within the cardiac blood flow pathway, and to compress after injection of contrast agent into the cardiac blood flow pathway, An internal catheter configured to deliver a medical implant and the stasis device through the blood flow pathway of the heart and in close proximity to the tissue wall of the heart, A delivery system comprising a delivery device configured to operate at least a portion of the medical implant to a desired position relative to the tissue wall of the heart.

Images