Shape-memory valvular leak plug and delivery catheter for multiple plugs

Abstract

An apparatus includes multiple valvular plugs configured for deployment within one or more paravalvular leaks inside a heart of a patient and adjacent to a prosthetic heart valve. The apparatus also includes a valvular plug delivery catheter comprising a lumen. The valvular plugs are positioned proximate to one another inside the lumen, such that the valvular plug delivery catheter is configured to deploy a first valvular plug and a second valvular plug without the delivery catheter being removed from the body of the patient between deploying the first valvular plug and deploying the second valvular plug.

Description

SHAPE-MEMORY VALVULAR LEAK PLUG AND DELIVERY CATHETER FOR MULTIPLE PLUGSTECHNICAL FIELD

[0001] The subject matter described herein relates to stopping leakage around replacement heart valves and, in particular, to plugging paravalvular leaks during and after a cardiac valve replacement procedure. For example, multiple shape-memory plugs can be catheter-deployed to stop such leaks.BACKGROUND

[0002] With the advent of minimally invasive procedures, heart valve replacement may be performed through intraluminal procedures. For example, transvenous / transcatheter aortic valve replacement (TAVR) is becoming a more common valve replacement procedure, as technology and doctor skillsets improve. This minimally invasive approach to valve replacement is an alternative to open heart surgical aortic valve replacement (SAVR). However, such procedures carry a risk of paravalvular leaks, which must also be repaired using intraluminal techniques.

[0003] Vascular plugs have been used to repair paravalvular leakage in patients via percutaneous catheterization for some time. However, such treatments have drawbacks as well, such as cost for the device(s), shadowing of anatomy on fluoroscopic imaging by the devices, and the frequent need for more than one device to be used due to the size of leakage orifice and / or that there are multiple leakage sites.

[0004] Vascular plugs are traditionally made from a shape memory alloy wire, such as Nitinol, that has been heat set into the desired shape. A typical Nitinol-bodied plug used to treat paravalvular leakage may be constructed with a stent-like expandable wire frame made from braided Nitinol wires that are crimped into ferules on either end, one of which is usually threaded to allow for a delivery wire to be attached at the time of manufacture, and then detached (e.g., unscrewed) once the device is placed. There may also be fabric covering the frame, or within the frame to promote plugging the hole through clotting (e.g., with platelets) and eventual endothelialization (cell overgrowth) of the fabric.

[0005] Such devices are typically sold with a single plug connected to a delivery wire and pre-loaded into a delivery catheter. Frequently, this requires that multiple catheters are needed to treat a single patient. In an example, a first catheter is inserted into a patient, the plug is deployed, and then the catheter is withdrawn completely from the body and replacedwith a second catheter, from which a second plug is deployed, and so on. This can increase the cost of the valve replacement procedure, as well as increasing the time, complexity, and risk required to complete the procedure. As mentioned above, because the devices are made from a cage of metallic wire, they can also cause shadowing, or the inability to properly image anatomy, using fluoroscopic or ultrasound imaging.

[0006] The information included in this Introduction section of the specification, including any references cited herein and any description or discussion thereof, is included for context and / or technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound or otherwise limited in any manner.SUMMARY

[0007] Disclosed herein is a paravalvular leak plugging device, with associated systems, and a method to treat perivalvular leakage using multiple shape memory foam plugs that have been pre-loaded into a single delivery system. The device includes a catheter-based deployment device, as well as one or more plugs made of a shape-memory foam that is relatively transparent to X-rays and ultrasound, and that expands on contact with human body temperature. The catheter can be placed in front of a leak, and a pushing device can push a plug into the leak. The plug then expands into the leak as the catheter is retracted. A narrowing feature or waist in the plug keeps it situated within the leak. Additional plugs may be deployed from the catheter as needed, without withdrawing the catheter from the patient. The paravalvular leak plugging device has particular but not exclusive utility for plugging paravalvular leaks during and after intracardiac valve replacement procedures.

[0008] One general aspect includes an apparatus. The apparatus includes a valvular plug configured to be positioned within a paravalvular leak inside a heart of a patient and adjacent to a prosthetic heart valve. The valvular plug includes a proximal lobe, a distal lobe, and a waist extending between the proximal lobe and the distal lobe. The proximal lobe, the distal lobe, and the waist include a foam configured to transition between a compressed state and an expanded state to contact native tissue of the heart and an outer perimeter of the prosthetic heart valve.

[0009] Implementations may include one or more of the following features. In some aspects, the foam defines the outer surface of the valvular plug. In some aspects, the valvular plug may include a dumbbell shape defined by the foam. In some aspects, the foam, in the expanded state, is configured to conform to at least one of the native tissue of the heart or the outer perimeter of the prosthetic heart valve. In some aspects, the foam may include a shape memory foam configured to transition from the compressed state to the expanded state in response a temperature inside the patient. In some aspects, a length of the proximal lobe and a length of the distal lobe are greater than a length of the waist. In some aspects, the valvular plug may include a central longitudinal wire. In some aspects, the foam forming the proximal lobe, the distal lobe, and the waist surrounds the central longitudinal wire. In some aspects, the valvular plug may include only the foam. In some aspects, the valvular plug may include a radiopaque marker. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0010] One general aspect includes an apparatus that includes a plurality of valvular plugs configured for deployment within one or more paravalvular leaks inside a heart of a patient and adjacent to a prosthetic heart valve; and a valvular plug delivery catheter that includes a lumen configured to receive the plurality of valvular plugs and hold the plurality of valvular plugs positioned proximate to one another inside the lumen. The valvular plug delivery catheter is configured to be positioned within a body of a patient and to deploy the plurality of valvular plugs from the lumen while remaining positioned within the body of the patient. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0011] Implementations may include one or more of the following features. In some aspects, the lumen is sized and shaped to maintain the plurality of valvular plugs inside the lumen in a compressed state, and each of the plurality of valvular plugs is configured to transition to an expanded state when the plurality of valvular plugs is deployed within the one or more paravalvular leaks. In some aspects, the plurality of valvular plugs include a foam. In some aspects, the valvular plug delivery catheter further comprises a pusher rod positioned inside the lumen proximal to the plurality of valvular plugs, and the pusher rod is configured to be moved longitudinally to push the plurality of valvular plugs out of an open distal end of the lumen for deployment within the one or more paravalvular leaks. In some aspects, a second valvular plug is positioned between a first valvular plug and the pusher rod; and the pusher rod is configured to, when longitudinally moved, cause a distal end of the pusher rod to contact a proximal end of the second valvular plug, a distal end of the second valvular plug to contact a proximal end of the first valvular plug, and a distal end of the first valvular plug to advanced out of the open distal end of the lumen. In some aspects, the plurality of valvular plugs include a continuous length of material, and the valvular plug delivery catheter is configured to separate the continuous length of material into the first valvular plug and the second valvular plug. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0012] One general aspect includes an apparatus that includes a valvular plug removal catheter that includes a tapered distal portion and a first lumen positioned proximal of the tapered distal portion. The tapered distal portion is configured to receive a valvular plug in an expanded state. The tapered distal portion includes a decreasing diameter along a distal to proximal direction. A wall of the tapered distal portion is configured to transition the valvular plug into a contracted state upon movement of the valvular plug in the distal to proximaldirection such that the valvular plug in the contracted state is received within the lumen. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0013] Implementations may include one or more of the following features. In some aspects, the valvular plug includes a shape memory foam, and the valvular plug removal catheter includes a second lumen proximate to tapered distal portion and a liquid configured to cool the shape memory foam during the movement of the valvular plug in the distal to proximal direction. In some aspects, the first lumen is configured for communication with a suction source configured to cause the movement of the valvular plug in the distal to proximal direction. In some aspects, the puller rod includes a snare, and the valvular plug includes an anchor configured to be engaged by the snare. The movement of the puller rod in the distal to proximal direction is configured to cause the movement of the valvular plug in the distal to proximal direction. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0014] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of aspects of the present disclosure, e.g., as defined in the claims, is provided in the following written description of various examples and / or aspects of the disclosure and illustrated in the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Illustrative aspects of the present disclosure will be described with reference to the accompanying drawings, of which:

[0016] Figure 1A is a side view of a human heart according to aspects of the present disclosure.

[0017] Figure IB is a cross-sectional side view of a human heart according to aspects of the present disclosure.

[0018] Figure l is a cross-sectional side view of an aortic valve replacement in a human heart 100 according to aspects of the present disclosure.

[0019] Figure 3 is a diagrammatic, cross-sectional top view of an aortic valve replacement of a degenerated natural aortic valve utilizing a TAVR valve, according to aspects of the present disclosure.

[0020] Figure 4A is a diagrammatic top view of a replacement valve (e.g., a prosthetic, mechanical, or donor valve) positioned within the heart, in the open position, according to aspects of the present disclosure.

[0021] Figure 4B is a diagrammatic top view of the replacement valve of Figure 4A in the closed position, according to aspects of the present disclosure.

[0022] Figure 5A is a diagrammatic cross-sectional side view of a replacement valve according to aspects of the present disclosure.

[0023] Figure 5B is a diagrammatic cross-sectional side views of a replacement valve according to aspects of the present disclosure.

[0024] Figure 6 is schematic, diagrammatic view of a system according to aspects of the present disclosure.

[0025] Figure 7A is a diagrammatic side view of an example paravalvular leak plug in its expanded state, according to aspects of the present disclosure.

[0026] Figure 7B is a diagrammatic side view of an example paravalvular leak plug in its compressed state, according to aspects of the present disclosure.

[0027] Figure 8 is a diagrammatic side view of an example paravalvular leak plug in its expanded state, according to aspects of the present disclosure.

[0028] Figure 9 is a diagrammatic side view of an example paravalvular leak plug in its expanded state, according to aspects of the present disclosure.

[0029] Figure 10A is a diagrammatic, lateral cross-sectional view of the paravalvular leak plug of Figure 7A, according to aspects of the present disclosure.

[0030] Figure 10B is a diagrammatic, lateral cross-sectional view of the paravalvular leak plug of Figure 7B, according to aspects of the present disclosure.

[0031] Figure 10C is a is a diagrammatic, lateral cross-sectional view of the paravalvular leak plug of Figure 8, according to aspects of the present disclosure.

[0032] Figure 11A is a diagrammatic, longitudinal cross-sectional view of an example paravalvular leakage treatment subsystem, according to aspects of the present disclosure.

[0033] Figure 11B is a diagrammatic, longitudinal cross-sectional view of an example paravalvular leakage treatment subsystem, according to aspects of the present disclosure.

[0034] Figure 12 is a diagrammatic, lateral cross-sectional view of the example plug delivery catheter of Figure 11 A or 1 IB, according to aspects of the present disclosure.

[0035] Figure 13A is a diagrammatic view of a shape-memory foam plug deployment process, according to aspects of the present disclosure.

[0036] Figure 13B is a diagrammatic view of a shape-memory foam plug deployment process 1300, according to aspects of the present disclosure.

[0037] Figure 13C is a diagrammatic view of a shape-memory foam plug deployment process, according to aspects of the present disclosure.

[0038] Figure 13D is a diagrammatic view of a shape-memory foam plug deployment process, according to aspects of the present disclosure.

[0039] Figure 13E is a diagrammatic view of a shape-memory foam plug deployment process, according to aspects of the present disclosure.

[0040] Figure 13F is a diagrammatic view of a shape-memory foam plug deployment process, according to aspects of the present disclosure.

[0041] Figure 13G is a diagrammatic view of a shape-memory foam plug deployment process, according to aspects of the present disclosure.

[0042] Figure 14A is a diagrammatic top view of the replacement valve of Figure 4A (e.g., a prosthetic, mechanical, or donor valve) positioned within the heart, in the open position, according to aspects of the present disclosure.

[0043] Figure 14B is a diagrammatic top view of the replacement valve of Figure 14A in the closed position, according to aspects of the present disclosure.

[0044] Figure 15A is a diagrammatic cross-sectional side view of the replacement valve of Figure 14A, according to aspects of the present disclosure.

[0045] Figure 15B is a diagrammatic cross-sectional side views of the replacement valve of Figure 14B, according to aspects of the present disclosure.

[0046] Figure 16A is a diagrammatic, longitudinal cross-sectional view of an example plug removal catheter, according to aspects of the present disclosure.

[0047] Figure 16B is a diagrammatic, longitudinal cross-sectional view of the example plug removal catheter of Figure 16A, according to aspects of the present disclosure.

[0048] Figure 17A is a diagrammatic, longitudinal cross-sectional view of an example plug removal catheter, according to aspects of the present disclosure.

[0049] Figure 17B is a diagrammatic, longitudinal cross-sectional view of the example plug removal catheter of Figure 17A, according to aspects of the present disclosure.

[0050] Figure 17C is a diagrammatic, longitudinal cross-sectional view of the example plug removal catheter of Figures 17A and 17B, according to aspects of the present disclosure.

[0051] Figure 18A is a diagrammatic, longitudinal cross-sectional view of an example plug deployment catheter, according to aspects of the present disclosure.

[0052] Figure 18B is a diagrammatic, longitudinal cross-sectional view of the example plug deployment catheter of Figure 18 A, according to aspects of the present disclosure.

[0053] Figure 19 is a schematic diagram of a processor circuit, according to aspects of the present disclosure.DETAILED DESCRIPTION

[0054] Disclosed herein is a method and device to treat perivalvular leakage using multiple shape memory foam plugs that have been pre-loaded into a single delivery system. The device includes a deployment catheter with pusher, as well as one or more plugs made of a shape-memory foam that can be pushed out from the catheter by the pusher. The shapememory foam may for example be a glycerol, polyurethane, or polyethylene foam, which is relatively transparent to X-rays and ultrasound and will thus not impede imaging of an implanted valve or surrounding structures, including the tissue surrounding the leak itself.

[0055] The shape-memory foam expands on contact with human body temperature, changing from a compressed, stiff structure to an expanded, rubbery one, and thus expands when pushed out from the distal end of the catheter. In some aspects, the foam material may expand when released from the confinement of the catheter, regardless of temperature. Thus, the catheter can be placed in front of a leak, and the pusher can push a plug into the leak orifice. The plug then expands into the leak orifice as the catheter is retracted away from the plug, while the plug remains stationary within the leak orifice. A narrowing feature or waist in the plug keeps it situated within the leak orifice while the portions of the plug that are proximal and distal of the orifice expand. Additional plugs may be deployed from the catheter as needed, without withdrawing the catheter from the patient, to plug multiple leaks or to place multiple plugs into a large leak.

[0056] The shape-memory foam may for example be an open-celled foam through which blood can pass, in order to promote clotting of the plug, and eventual endothelialization of the foam in order to fully plug the leak. In an example, clotting may occur over a period of minutes, whereas endothelialization may occur over a period of weeks.

[0057] Shape memory foam has been used as an embolic treatment for vascular diseases such as aneurysms, where the shape memory foam is placed around a wire with a means to detach the embolic plug from the delivery system, or where the plug is simply pushed out of the end of the delivery catheter without any means to recapture and redeploy the device in the even it is not delivered in an acceptable manner. It is therefore advantageous to provide a less expensive method to deliver multiple plugs that don’t shadow imaging as much as current methods do.

[0058] A specialized plug, intended for paravalvular leakage and made from a shape memory foam, can solve most of the issues encountered with a traditional vascular plug. Since the plugs can be made with a simple central wire covered with shape memory foam,they could be less costly to manufacture than Nitinol plugs, would provide less shadowing using either fluoroscopic or ultrasound imaging, and could have more than one device loaded into a simple delivery catheter, which would obviate the need to pull multiple devices to treat a single patient.

[0059] Described herein is a plug made from a shape-memory foam that is specifically formed in a dumbbell-like shape to plug paravalvular leaks, with multiple (e.g., 2 or more) devices preloaded into a simple tube delivery catheter. Each plug can be “crimped” down to fit within the delivery catheter. Once delivered out to of the delivery catheter, the plug can swell due to the temperature of the patient’s body, anchoring itself in the orifice that is allowing for the paravalvular leakage. Because there is more than one device loaded into the system, if a single plug is insufficient to close the orifice, sequential plugs can be delivered without the need to pull the catheter out and guide in another one.

[0060] The delivery catheter may be either a rapid exchange type catheter, where the guide wire used to direct the catheter to the delivery site is passed through a short lumen on the side of the catheter, or by an “over the wire” type catheter, where the guide wire is passed through a lumen off to the side of the catheter and runs the length of the catheter. A pusher, like a stent dilator but without the tapered end, could be used to sequentially push out the plugs in a system similar to Tack Endovascular stents.

[0061] Once the delivery system is placed across the orifice to be plugged, the pusher partially delivers a plug. Once the plug’s distal end has expanded, beyond the distal side of the orifice, the delivery system is retracted while the pusher is held stationary, allowing the waist of the plug to be delivered into the orifice. As the delivery system continues to be retracted, the proximal end of the plug also expands, anchoring it in place. If another plug is required, the delivery catheter is re-advanced across the orifice, and the process is repeated. Once the orifice is plugged, the guidewire can be retrieved.

[0062] A wire core, the length of the plug, is coated with shape-memory foam. Depending upon how the foam is formed on the core, it may be molded to the desired shape, or could be formed in a cylinder that is concentric to the wire which is then cut to the desired shape.

[0063] The formed plug is then “crimped” down to a cylindrical shape small enough to fit within the inside diameter of the delivery catheter, but large enough to provide friction against the delivery catheter, so the plugs don’t unintentionally exit from the distal end of the delivery system at improper times or positions. Multiple plugs may be inserted into the delivery system, with 3 or more being a typical target number. Is it noted that adding 1-2more plugs to a delivery system adds little to the cost or complexity of the system, as compared with requiring an additional delivery catheter, as is the case with present systems.

[0064] The plugs may be compliant enough that one size could work for all patients. However, multiple sizes (both diameter and length) are also possible, and may be used instead or in addition.

[0065] In some embodiments, radiopaque makers could be integrated into the metal core of the plug, or painted on the foam, to enhance the visibility of the plugs under X-ray. In other embodiments, the foam could be saturated by contrast agents (e.g., a gel containing microbubbles or gold particles, etc.) to improve the visibility under ultrasound imaging during the deployment.

[0066] In some embodiments, a retraction device could be used to remove the foam plugs from the body. The distal end of this device may consist of a cone which could be cooled down by passing a cold liquid through some channels around it in order for plug’s temperature and hence its size to decrease. An aspiration force could be used after the foam is engaged with the retrieval device to fully retract it into the device. In still other embodiments, a snare or an anchor (in case the core wire of the foam has a complementary loop or anchor) could also be used to pull the foam back towards the device’s distal end.

[0067] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the examples illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one example and / or aspect may be combined with the features, components, and / or steps described with respect to other examples and / or aspects of the present disclosure.Additionally, while the description below may refer to blood vessels, it will be understood that the present disclosure is not limited to such applications. For example, the devices, systems, and methods described herein may be used in any body chamber or body lumen, including an esophagus, veins, arteries, intestines, ventricles, atria, or any other body lumen and / or chamber. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.

[0068] Figure 1A is a side view of a human heart 100 according to aspects of the present disclosure. Visible are an aorta 102 from which stems a right coronary artery 104 and a left main coronary artery 106. The left main coronary artery 106 branches into a left circumflex coronary artery 108 and a left anterior descending coronary artery 110. The right coronary artery 104, the left main coronary artery 106, the left circumflex coronary artery 108, and a left anterior descending coronary artery 110 are the arteries that provide oxygen-rich blood to muscles of the human heart 100.

[0069] Figure IB is a cross-sectional side view of a human heart 100 according to aspects of the present disclosure. Visible are a right atrium 112 and a right ventricle 114. In that regard, oxygen-poor blood enters the human heart 100 in the right atrium 112 and travels to the right ventricle 114 through the tricuspid valve 116. The oxygen-poor blood leaves the right ventricle 114 and travels to the lungs. Also visible are a left atrium 118 and a left ventricle 120. In that regard, oxygen-rich blood is received from the lungs in the left atrium 118 and travels to the left ventricle 120 through the mitral valve 122. The oxygen-rich blood leaves the left ventricle 120 and goes out to the body through the aorta 102 via an aortic valve 124.

[0070] Figure 2 is a cross-sectional side view of an aortic valve 124 replacement in a human heart 100 according to aspects of the present disclosure. In some aspects, e.g., when aortic valve stenosis has occurred to the aortic valve 124 that keeps blood flowing in the correct direction from the left ventricle 120 to the aorta 102, a transvenous / transcatheter aortic valve repair (TAVR) procedure may be performed to replace the natural aortic valve 124 with a replacement aortic valve 202. In some instances, portions of one or more leaflets 204 of the natural aortic valve 124 may be resected so that openings 206 and 208 to the right coronary artery 104 and the left main coronary artery 106, respectively, so that, when the one or more leaflets 204 are pressed against the natural heart wall 210, the openings 206 and 208 remain unobstructed so that oxygen-rich blood may flow to the muscles of the human heart. The natural heart wall 210 may be a natural aorta wall, a natural heart chamber wall, or a natural aortic valve wall.

[0071] The TAVR procedure is shown here for exemplary purposes only; it is understood that other heart valves and heart valve replacement procedure types may generate paravalvular leaks that require plugging, and thus fall within the scope of the present disclosure.

[0072] Figure 3 is a diagrammatic, cross-sectional top view of an aortic valve replacement 300 of a degenerated natural aortic valve utilizing a TAVR valve, according toaspects of the present disclosure. Visible are the natural heart wall 210, the natural aortic valve leaflets 304, the TAVR valve wall 306, the TAVR valve leaflets 308, and the TAVR commissural tabs 310. The TAVR valve leaflets 308 may for example be constructed from bovine animal tissue coupled to the wire frame of the TAVR valve wall 306 via the commissural tabs 310. When inserted, the TAVR valve pushes the remaining unresected portions of the natural aortic valve leaflets 304 against the natural heart wall 210 such that the natural aortic valve leaflets 304 are pinned and / or secured between an outside of the TAVR valve wall 306 and the natural heart wall 210.

[0073] Figure 4A is a diagrammatic top view of a replacement valve 300 (e.g., a prosthetic, mechanical, or donor valve) positioned within the heart, in the open position, according to aspects of the present disclosure. The leaflets 308 of the replacement valve periodically open (to allow blood flow in desired direction) and closed (to prevent blood flow in opposite undesired direction) during heart cycle. Artificial leaflets are one example of a mechanism that open / closes to periodically allow / stop blood flow, but a mechanical / prosthetic valve or donor valve can have any suitable mechanism that open / closes to periodically allow / stop blood flow.

[0074] In the example shown in Figure 4A, the replacement valve wall 306 is joined to the natural heart wall 210, but it is imperfect because of a relatively smaller paravalvular leak 410 and a relatively larger paravalvular leak 420. A paravalvular leak is gap between the outer / outermost perimeter or surface of the replacement valve (e.g., a prosthetic valve cuff) and the natural heart tissue (e.g., native annulus).

[0075] Figure 4B is a diagrammatic top view of the replacement valve 300 of Figure 4A in the closed position, according to aspects of the present disclosure. Visible are the heart wall 210, replacement valve wall 306, leaflets 308, small paravalvular leak 410, and larger paravalvular leak 420. In the closed position, the leaflets 308 should cause blood to stop flowing through the valve. However, because blood can flow through the paravalvular leaks 410 and 420, the functioning of the replacement valve 300 may be significantly compromised.

[0076] Figure 5A is a diagrammatic cross-sectional side view of a replacement valve 300 according to aspects of the present disclosure. Visible are the natural heart wall 210 and the replacement valve leaflets 308. In the example shown in Figure 5A, during systole (indicated by directional arrows 604), the valve leaflets 308 open and allow blood to flow from the left ventricle 120 to the aorta 102 indicated by directional arrows 504. However, paravalvular leak 420 allows leakage flow 520 to bypass the valve. Such leakage flow 520 is in the samedirection as the normal blood flow 504, but may adversely impact the flow velocity, flow volume that should be entering the aorta 102.

[0077] Figure 5B is a diagrammatic cross-sectional side views of a replacement valve 300 according to aspects of the present disclosure. Visible are the natural heart wall 210 and the replacement valve leaflets 308. In the example shown in Figure 5B, during diastole (indicated by directional arrows 506), the valve leaflets 308 may be pushed by the flow of blood from the aorta 102 toward the left ventricle 120 such that the valve leaflets 308 close to prevent mitral regurgitation. However, the paravalvular leak 420 allows leakage flow 530 in direction 506, where blood should not be flowing at all, thus significantly compromising the function of the replacement valve 300, by effectively causing or emulating regurgitation (which may, in some cases, be a symptom for which the natural valve was replaced). Thus, to prevent such leakage flow 530, it may be critically important for the health of the patient to block or plug the paravalvular leak 420.

[0078] Figure 6 is schematic, diagrammatic view of a system 600 according to aspects of the present disclosure. The system 600 may be configured to evaluate (e.g., assess), display, and / or control (e.g., modify) one or more aspects of a cardiac valve replacement. For instance, the system 600 may be utilized to monitor and / or control one or more portions of a cardiac valve replacement process while reducing and / or eliminating paravalvular leaks. In this regard, the system 600 may be used to assess coronary vessels and / or heart tissue (e.g., the myocardium). As illustrated, the system 600 may include a processing system 610 in communication with a display device 620 (e.g., an electronic display or monitor), an input device 630 (e.g., a user input device, such as a keyboard, mouse, joystick, microphone, and / or other controller or input device), a paravalvular leakage treatment subsystem 640 and / or an imaging device 660 (e.g., x-ray, computed tomography or CT, magnetic resonance imaging or MRI, etc.). As illustrated, the system 600 may further include a replacement valve delivery catheter 680 and a replacement (e.g., prosthetic, mechanical, or donor) valve 690, which may be completely mechanical or may be connected to processing system 610 in order to provide intraluminal data to processing system 610. It is understood that other types of valves and valve delivery systems may be used instead of or in addition to those described herein.

[0079] The paravalvular leakage treatment subsystem 640 includes a plug delivery catheter 644, a pusher 646, and a plurality of shape-memory foam plugs 700 that can be deployed from the plug delivery catheter 644 by being pushed out by the pusher 646. Eitheror both of the plug delivery catheter 644 and the valve delivery catheter may be guided over a guidewire 648.

[0080] The processing system 610 is generally representative of any device suitable for performing the processing and analysis techniques disclosed herein. In some aspects, the processing system 610 includes a processor circuit, such as the processor circuit 1900 of Figure 19. In some aspects, the processing system 610 is programmed to execute steps associated with the data acquisition, analysis, and / or instrument (e.g., device) control described herein. Accordingly, it is understood that any steps related to data acquisition, data processing, instrument control, and / or other processing or control aspects of the present disclosure may be implemented by the processing system 610 (e.g., computing device) using corresponding instructions stored on or in a non-transitory computer readable medium accessible by the computing device. In some instances, the processing system 610 is a console device. Further, it is understood that in some instances the processing system 610 includes one or a plurality of computing devices, such as computers, with one or a plurality of processor circuits. In this regard, it is particularly understood that the different processing and / or control aspects of the present disclosure may be implemented separately or within predefined groupings using a plurality of computing devices. Any divisions and / or combinations of the processing and / or control aspects described below across multiple computing devices are within the scope of the present disclosure.

[0081] The system 600 is configured such that when the plug delivery catheter 644 is positioned within the heart, images captured by the imaging system 660 can show the location and orientation of the plug delivery catheter 644, and also potentially anatomical features such as the replacement valve 690, heart wall, and heart valve leaflets. Advantageously, images obtained by the imaging device 660 of the foam plugs 700 do not obscure anatomy behind the foam plugs 700 because the foam that forms the body of the plugs 700 is transparent to, e.g., x-ray. The anatomy behind the plug 700 is important for a clinician to see because this is the anatomy that has the defect (the paravalvular leak) that needs to be fixed. Thus, the foam plugs 700 are advantageous compared to other devices for plugging paravalvular leaks that are formed of metal or metal allow (e.g., braided metal wires), which is not transparent to x-ray and thus does obscure anatomy in x-ray images.

[0082] It is noted that block diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, block diagrams may show a particular arrangement of components, subcomponents, modules, units, etc. It is understood that someembodiments of the systems disclosed herein may include additional components, that some components shown may be absent from some embodiments, and that the arrangement of components may be different than shown, while still performing the methods described herein.

[0083] It is understood that, in some instances, one or more components of the system 600 can operate without one or more other components of the system 600. For example, the paravalvular leakage treatment subsystem 640, guidewire 648, valve delivery catheter 680, and / or prosthetic / mechanical valve 690 can be implemented without the processing system 610. For example, the paravalvular leakage treatment subsystem 640, guidewire 648, valve delivery catheter 680, and / or prosthetic / mechanical valve 690 can be mechanical components that do not have signal communication with the processing system 610.

[0084] Figure 7A is a diagrammatic side view of an example paravalvular leak plug 700 in its expanded state, according to aspects of the present disclosure. In the example shown in Figure 7A, the paravalvular leak plug 700 is made entirely of shape-memory foam, and includes a distal tip 710, distal lobe 720, a waist, neck, or narrowing feature 730, proximal lobe 740, and proximal tip 750. The expanded plug 700 has a length Leand a total diameter De. The waist 730 fits into the orifice of a leak as shown below, while the distal and proximal lobes expand to block the flow of blood, and to attract platelets to encourage clotting and eventual endothelialization of the plug 700.

[0085] Figure 7B is a diagrammatic side view of an example paravalvular leak plug 700 in its compressed state, according to aspects of the present disclosure. Visible are the distal tip 710, distal lobe 720, waist 730, proximal lobe 740, and proximal tip 750. In the compressed state, the plug 700, has a smaller diameter Dcsuch that it can fit inside a delivery catheter, and may also have a shorter length Lc.

[0086] Figure 8 is a diagrammatic side view of an example paravalvular leak plug 700 in its expanded state, according to aspects of the present disclosure. The plug 700 of Figure 8 is similar to that of Figure 7A, except that the plug is formed around a central wire 800, such that the distal lobe 720 and proximal lobe 740 of the plug are made of shape-memory foam, but the distal tip, 710, waist 730, and proximal tip 750 are portions of the wire 800. The wire 800 may be metallic, or may be made of other materials including but not limited to polymers or ceramics.

[0087] Figure 9 is a diagrammatic side view of an example paravalvular leak plug 700 in its expanded state, according to aspects of the present disclosure. The plug 700 of Figure 9 is similar to that of Figure 8, except that radiopaque markers 910 have been added, to help theplug show up on X-ray imaging during the procedure, while leaving the plug 700 generally transparent so that surrounding structures are not blocked. The shape-memory foam material has also been impregnated with an ultrasound contrast material 920, such that during the implantation procedure, the plug (or portions thereof) shows up clearly in ultrasound imaging.

[0088] Figure 10A is a diagrammatic, lateral cross-sectional view of the paravalvular leak plug 700 of Figure 7A, according to aspects of the present disclosure. Visible is the proximal lobe 740, made of shape-memory foam 1000. In the expanded state, the leak plug 700 has a total diameter of De.

[0089] Figure 10B is a diagrammatic, lateral cross-sectional view of the paravalvular leak plug 700 of Figure 7B, according to aspects of the present disclosure. Visible is the proximal lobe 740, made of shape-memory foam 1000. In the compressed state, the leak plug 700 has a total diameter of Dc.

[0090] Figure 10C is a is a diagrammatic, lateral cross-sectional view of the paravalvular leak plug 700 of Figure 8, according to aspects of the present disclosure. Visible are the proximal lobe 740, made of shape-memory foam 1000, and the central wire 800, which may for example be made of metal to which the memory foam 1000 is fixedly attached (e.g., by an adhesive, or by natural adhesion between the material of the foam 1000 and the material of the wire 800.

[0091] Figure 11A is a diagrammatic, longitudinal cross-sectional view of an example paravalvular leakage treatment subsystem 640, according to aspects of the present disclosure. Visible are the plug delivery catheter 644, pusher 646, and guidewire 648, within a guidewire lumen 1110. Also visible, within a delivery lumen 1120, are three paravalvular leak plugs 700.

[0092] The plug delivery catheter 644 includes a flexible elongate catheter body 645 with a proximal portion terminating at a proximal end, a distal portion terminating at distal end. The delivery lumen or first lumen 1120 holds the foam plugs 700 and at least a portion of the flexible elongate pusher 646, although another portion of the pusher may extend proximally from the proximal end of the catheter 644 such that a clinician can manipulate the pusher. The pusher 646 may for example be a flexible elongate rod of material (e.g., a metal or a polymer) with a solid cross-section or mostly solid cross-section for pushing foam plugs 700 out of the catheter 644. The pusher 646 has a proximal portion terminating at a proximal end, and a distal portion terminating at a distal end. A clinician can hold the proximal end and translate the pusher 646 distally and proximally as needed, to push foam plugs 700 outthrough the distal end of the catheter 644. In that regard, in some aspects, the proximal end of the pusher may include a handle or other manipulator.

[0093] One or multiple plugs 700 can be retained inside the first lumen or delivery lumen 1120, such that the sides of the plugs 700 contact the inner circumference of the first lumen or delivery lumen 1120. In that regard, the delivery lumen 1120 helps maintain the foam plugs 700 in their compressed state, with a friction fit sufficiently tight that the foam plugs 700 do not spontaneously move around in the delivery lumen 1120 or exit through the distal end of the catheter 644 while the catheter 644 is manipulated or navigated through tortuous vasculature. However, the delivery lumen 1120 also retains the foam plugs 700 loosely enough that the foam plugs 700 readily move in a distal direction when pushed by the pusher 646. In some aspects, the plugs 700 are adjacent to one another along the length of the delivery lumen 1120.

[0094] In the example shown in Figure 11 A, the catheter 644 is an over-the-wire catheter, and the guidewire lumen or second lumen 1110 extends for the full length, or most of the length, of the catheter body 645. The guidewire includes a proximal portion terminating at a proximal end, and a distal portion terminating at a distal end.

[0095] When a user such as a clinician translates the pusher 646 in a distal direction, the distal end of the pusher contacts the proximal end of the proximal-most foam plug 700. This causes contact between the distal end of the proximal-most foam plug 700 and the proximal end of the next foam plug 700 in line, and so on. This causes the distal-most foam plug 700 to exit (e.g., to be ejected or deployed) from the distal end of the plug delivery lumen 1120 via the open distal end of the delivery lumen 1120, such that the ejected plug 700 can be used to plug a paravalvular leak.

[0096] Figure 11B is a diagrammatic, longitudinal cross-sectional view of an example paravalvular leakage treatment subsystem 640, according to aspects of the present disclosure. Visible are the delivery catheter 644, pusher 646, and guidewire 648, guidewire lumen 1110. delivery lumen 1120, and three paravalvular leak plugs 700. The paravalvular leakage treatment subsystem 640 of Figure 1 IB is similar to that of Figure 11 A, except that the catheter 644 is a rapid exchange catheter rather than an over-the-wire catheter, so the guidewire lumen 1110 is located in the distal portion of the catheter body 645 and does not extend for the entire length of the catheter.

[0097] Figure 12 is a diagrammatic, lateral cross-sectional view of the example plug delivery catheter 644 of Figure 11 A or 1 IB, according to aspects of the present disclosure. Visible are the catheter body 645, delivery lumen 1120, guidewire lumen 1110, guidewire648, and a shape-memory foam plug 700. In the case of an over-the-wire catheter, the guidewire lumen 1110 may extend for the entire length, or nearly the entire length, of the catheter body 645, whereas for a rapid exchange catheter, the guidewire lumen 1110 is substantially shorter than the catheter body 645, and located in the distal portion of the catheter body 645.

[0098] Figure 13A is a diagrammatic view of a shape-memory foam plug deployment process 1300, according to aspects of the present disclosure. Visible are the delivery catheter 644, delivery lumen 1120, pusher 646, guidewire 648, two foam plugs 700, the heart wall, native annulus, or other heart tissue 210, the replacement valve wall or cuff 306, and a defect 410 in between the heart tissue 210 and the valve wall 306. The apparatus is shown in this orientation for ease of illustration; it is understood that inside a patient’s anatomy, the replacement valve cuff 306 and native annulus 210 can be oriented horizontally and plug delivery catheter 644 oriented vertically. Still other orientations are possible, and fall within the scope of the present disclosure. Depending on the implementation, the delivery catheter 644 could contain one, two, three or more foam plugs 700.

[0099] In an example, the defect 410 is a paravalvular leak, e.g., a gap between the replacement valve cuff 306 and the native annulus 210, although a person of ordinary skill in the art will appreciate that other types of defects could be plugged in the same or a similar way. If the procedure is in aortic valve replacement, then the distal end of the catheter 644 may begin inside the aorta. If the procedure is a mitral valve replacement, then the distal end of catheter 644 may begin inside left atrium (e.g., having entered from the right atrium through the interatrial septum).

[0100] In a first step of the process 1300, the user extends the guidewire 648 through the defect 410, and then translates the plug delivery catheter 644 distally along the guidewire 648 toward the defect 410.

[0101] Figure 13B is a diagrammatic view of a shape-memory foam plug deployment process 1300, according to aspects of the present disclosure. Visible are the delivery catheter 644, delivery lumen 1120, pusher 646, guidewire 648, two foam plugs 700, the heart wall, native annulus, or other heart tissue 210, the replacement valve wall or cuff 306, and a defect 410 in between the heart tissue 210 and the valve wall 306. In a second step of the process 1300, the user moves the plug delivery catheter 644 distally along the guidewire 648 until the distal end of the catheter 644 is distal of the paravalvular leak 410. If the procedure is an aortic valve replacement, then the distal end of the catheter 644 will now be inside the left ventricle (e.g., element 120 in Fig. IB). If the procedure is a mitral valve replacement, thenthe distal end of the catheter 644 will also now be inside left ventricle (e.g., element 120 in Fig. IB). The guidewire 648 is then withdrawn (e.g., moved in a proximal direction) to get it out of the paravalvular leak 410 so that foam plugs 700 can be deployed into the leak 410 without interference by the guidewire 648.

[0102] Figure 13C is a diagrammatic view of a shape-memory foam plug deployment process 1300, according to aspects of the present disclosure. Visible are the delivery catheter 644, delivery lumen 1120, pusher 646, guidewire 648, two foam plugs 700, the heart wall, native annulus, or other heart tissue 210, the replacement valve wall or cuff 306, and a defect 410 in between the heart tissue 210 and the valve wall 306. In a third step of the process 1300, the user has moved the guidewire out of the defect 410, and now moves the pusher 646 distally, which pushes the distal portion 1310 of the distal -most plug 700 out of the distal end of the plug delivery catheter 644. The distal lobe 720 of the distal-most plug 700 is now free to expand.

[0103] Figure 13D is a diagrammatic view of a shape-memory foam plug deployment process 1300, according to aspects of the present disclosure. Visible are the delivery catheter 644, delivery lumen 1120, pusher 646, guidewire 648, two foam plugs 700, the heart wall, native annulus, or other heart tissue 210, the replacement valve wall or cuff 306, and a defect 410 in between the heart tissue 210 and the valve wall 306. In a fourth step of the process 1300, the distal lobe 720 of the distal-most plug 700 transitions to its expanded state, because outside of the plug delivery lumen 1120, the distal lobe 720 is exposed more directly to the patient’s body heat, and at the same time the distal lobe 720 is no longer being compressed by the inner walls of the plug delivery lumen 1120. However, the proximal lobe 740 of the distal-most plug 700 remains in a compressed state within the plug delivery lumen 1120, even though it could be exposed to increased temperature inside the patient’s body, if the catheter body is non-compliant and does not allow the expansion.

[0104] Figure 13E is a diagrammatic view of a shape-memory foam plug deployment process 1300, according to aspects of the present disclosure. Visible are the delivery catheter 644, delivery lumen 1120, pusher 646, guidewire 648, two foam plugs 700, the heart wall, native annulus, or other heart tissue 210, the replacement valve wall or cuff 306, and a defect 410 in between the heart tissue 210 and the valve wall 306. In a fifth step of the process 1300, the user moves the plug delivery catheter 644 proximally along the guidewire 648 until the distal end of catheter 644 is positioned in the defect 410, between the replacement valve cuff 306 and the native annulus 210. Because the proximal lobe 740 of the distal-most plug 700 is still contact with the inner circumference of the primary lumen, the distal-most plug700 moves proximally as well, until the proximal end of the distal lobe of the distal-most foam plug comes into contact with the ventricular side of the defect 410 (e.g., the distal side of the replacement valve cuff 306 and native annulus 210). The proximal end of the distal lobe 720 of the distal-most foam plug 700 is somewhat compliant, and can conform to the shape of the ventricular side of the defect 410 (e.g., to the distal side of the replacement valve cuff 306 and native annulus 210).

[0105] Figure 13F is a diagrammatic view of a shape-memory foam plug deployment process 1300, according to aspects of the present disclosure. Visible are the delivery catheter 644, delivery lumen 1120, pusher 646, guidewire 648, two foam plugs 700, the heart wall, native annulus, or other heart tissue 210, the replacement valve wall or cuff 306, and a defect 410 in between the heart tissue 210 and the valve wall 306. In a sixth step of the process 1300, the user moves the pusher 646 distally, which pushes the proximal lobe 740 of the distal-most plug 700 out of distal end of the plug delivery catheter 644. Subsequently or simultaneously, the user moves the plug delivery catheter 644 proximally, such that the distal-most foam plug 700 remains relatively stationary within the defect or paravalvular leak 410 (e.g., positioned between the replacement valve cuff 306 and the native annulus 210.) The distal end of the delivery catheter 644 is now proximal of the defect 410, and the proximal lobe 740 of the distal-most foam plug 700 is free to expand.

[0106] Figure 13G is a diagrammatic view of a shape-memory foam plug deployment process 1300, according to aspects of the present disclosure. Visible are the delivery catheter 644, delivery lumen 1120, pusher 646, guidewire 648, two foam plugs 700, the heart wall, native annulus, or other heart tissue 210, the replacement valve wall or cuff 306, and a defect 410 in between the heart tissue 210 and the valve wall 306. In a seventh step of the process 1300, the proximal lobe 740 and waist 730 of the distal-most foam plug 700 transition from their compressed state to their expanded state, because outside of the plug delivery lumen they are no longer compressed by the lumen walls, and may be more directly exposed to the body heat of the patient. As a result, the distal end of the proximal lobe of foam plug comes into contact with aortic / atrial side of defect (proximal side of prosthetic valve cuff and native annulus).

[0107] Because the shape-memory foam is somewhat compliant, the distal end of the proximal lobe 740 of the distal-most foam plug 700 can conform to the features of the aortic / atrial side of the defect 410 (e.g., can conform to the proximal side of the replacement valve cuff 306 and native annulus 210. The waist 730 of the plug 700 is in between the proximal lobe 740 and the distal lobe 720. Opposite side surfaces of the waist 730 contactthe replacement valve cuff 306 and native annulus 210, respectively. The foam plug 700 thus provides closure of the paravalvular leak 410 by filling the gap between the replacement valve cuff 306 and the native annulus 210. At the time of implantation, the open-celled foam may be porous enough to allow some blood to flow through it. However, over a period of minutes, a clot (e.g., of blood platelets) will begin to form over the foam, thus making the plug relatively non-porous and impassable to the flow of blood. Subsequently, over a period of weeks, the foam will endothelialize and will have characteristics similar to those of the adjacent natural heart tissue 210.

[0108] The plug delivery catheter 644 can then be moved proximally, but can stay inside aorta or atrium for further use (as needed). One or more additional foam plugs 700 may remain inside the delivery lumen 1120 of the plug delivery catheter 644 - ready for deployment to plug additional leaks, without the normally routine need to removing the delivery catheter 644 from the body.

[0109] Figure 14A is a diagrammatic top view of the replacement valve 300 of Figure 4A (e.g., a prosthetic, mechanical, or donor valve) positioned within the heart, in the open position, according to aspects of the present disclosure. In the example shown in Figure 14A, the paravalvular leak 410 has been plugged with a shape-memory foam plug 700, sealing it. The larger paravalvular leak 420, being too large for a single plug, has been sealed with two shape-memory foam plugs 700.

[0110] Figure 14B is a diagrammatic top view of the replacement valve 300 of Figure 14A in the closed position, according to aspects of the present disclosure. Visible are the heart wall 210, replacement valve wall 306, leaflets 308, small paravalvular leak 410, and larger paravalvular leak 420. In the closed position, the leaflets 308 cause blood to stop flowing through the valve, while the plugs 700 prevent blood from flowing through the paravalvular leaks 410, 420.

[0111] Figure 15A is a diagrammatic cross-sectional side view of the replacement valve 300 of Figure 14A, according to aspects of the present disclosure. Visible are the natural heart wall 210 and the replacement valve leaflets 308. In the example shown in Figure 15A, during systole (indicated by directional arrow 604), the valve leaflets 308 open and allow blood to flow from the left ventricle 120 to the aorta 102 indicated by directional arrows 504. Furthermore, paravalvular leak 420 has been sealed with a foam plug 700, and thus does not allow allows leakage flow 520 to bypass the valve.

[0112] Figure 15B is a diagrammatic cross-sectional side views of the replacement valve 300 of Figure 14B, according to aspects of the present disclosure. Visible are the naturalheart wall 210 and the replacement valve leaflets 308. In the example shown in Figure 15B, during diastole (indicated by directional arrows 606), the valve leaflets 308 may be pushed by the flow of blood from the aorta 102 toward the left ventricle 120 such that the valve leaflets 308 close to prevent mitral regurgitation. Furthermore, the paravalvular leak 420 has been sealed with a foam plug 700, and thus does not allow leakage flow 530 in direction 506, therefore restoring the normal, healthy functioning of the replacement valve 300.

[0113] Figure 16A is a diagrammatic, longitudinal cross-sectional view of an example plug removal catheter 1600, according to aspects of the present disclosure. In cases where a foam plug 700 has been placed incorrectly, or has deployed accidentally, it may be necessary or desirable to remove the plug from the patient’s body, before the plug has a chance to clot and / or endothelialize, while the shape-memory foam is still compliant. Therefore, the plug removal catheter 1600 includes a flexible elongate catheter body 1610, a cooling liquid channel 1620, a tapered, cone-shaped distal entrance 1630, and a retrieval lumen 1640. As the foam plug 700 moves in the proximal direction, the walls of the cone-shaped distal entrance 1630 exert a force on the plug 700, which transitions the plug 700 from the expanded state into the contracted state. When a cooling liquid 1625 (e.g., saline or a refrigerant), supplied by a cooling liquid source 1650, is circulated through the cooling liquid channel 1620 while a foam plug 700 is in contact with the cone-shaped distal entrance 1630, the foam plug is cooled, and may thus be encouraged to contract. When a suction force or aspiration force 1645 is applied by an aspiration source or suction source 1660 through the retrieval lumen 1640, the foam plug 700 is pulled into the retrieval lumen 1640.

[0114] It is noted that in some aspects, the plug removal catheter 1600 may also serve as a plug delivery catheter, wherein the pusher rod and plugs can be delivered using the lumen 1640.

[0115] Figure 16B is a diagrammatic, longitudinal cross-sectional view of the example plug removal catheter 1600 of Figure 16A, according to aspects of the present disclosure. Visible are the catheter body 1610, cooling liquid channel 1620, tapered, cone-shaped distal entrance 1630, retrieval lumen 1640, cooling liquid source 1650, and aspiration source 1660. In the example shown in Figure 16B, the foam plug 700 has been compressed and pulled into the retrieval lumen 1640. Depending on the implementation and the need, the plug removal catheter 1600 may then be removed from the body, or else the plug 700 may be pulled all the way through the retrieval lumen 1640 and outside the patient’s body, so that an additional plug 700 can be removed.

[0116] Depending on the implementation, the cooling liquid source 1650 and / or the aspiration source 1660 can be coupled to a processor or can operate separately (e.g., with user-operable on / off controls).

[0117] Figure 17A is a diagrammatic, longitudinal cross-sectional view of an example plug removal catheter 1700, according to aspects of the present disclosure. The plug removal catheter 1700 includes a catheter body 1710 with a tapered, conical distal entrance 1730 and a retrieval lumen 1740. However, unlike the plug removal catheter 1600 of Figures 16A and 16B, the plug removal catheter 1700 includes a puller 1770 (e.g., a flexible elongate rod of material such as a metal or polymer that has a solid or mostly solid cross-section) attached to a lasso or snare 1780. Furthermore, the foam plug 700 includes a wire core 800, to which an anchor 1790 is fixedly attached. When the puller 1770 is extended beyond the conical opening 1730, the lasso or snare 1780 can be used to grab the anchor 1790 and pull the foam plug 700 into the tapered, cone-shaped entrance to compress it and pull it into the retrieval lumen 1740.

[0118] In some implementations, the snare 1780 and anchor 1790 can be reversed, e.g., the anchor 1790 can be attached to the puller 1770 and the snare 1780 can be attached to the wire core 800 of the plug 700. In some implementations, the plug removal catheter 1600 may also serve as a plug delivery catheter, wherein the puller rod 1770 can be replaced with a pusher rod and valvular plugs.

[0119]

[0120] Figure 17B is a diagrammatic, longitudinal cross-sectional view of the example plug removal catheter 1700 of Figure 17A, according to aspects of the present disclosure. Visible are the plug 700, wire core 800, catheter body 1710, tapered conical distal entrance 1730, retrieval lumen 1740, puller 1770, snare 1780, and anchor 1790. In the example shown in Figure 17B, the snare 1780 has snared the anchor 1790, and the puller 1770 has pulled the plug 700 into the opening 1730 such that the plug 700 is in contact with the sides of the opening 1730, such that further pulling by the puller will compress the plug 700.

[0121] Figure 17C is a diagrammatic, longitudinal cross-sectional view of the example plug removal catheter 1700 of Figures 17A and 17B, according to aspects of the present disclosure. Visible are the plug 700, wire core 800, catheter body 1710, tapered conical distal entrance 1730, retrieval lumen 1740, puller 1770, snare 1780, and anchor 1790. In the example shown in Figure 17C, the puller 1770 has pulled the snare 1780 and anchor 1790 until the plug 700 is pulled all the way into the retrieval lumen 1740, in its compressed state. Depending on the implementation and the need, the plug may be pulled entirely outside of thebody and the retrieval lumen, so that another plug may be snared and removed, or else the entire plug removal catheter 1700 may be removed from the patient’s body.

[0122] Figure 18A is a diagrammatic, longitudinal cross-sectional view of an example plug deployment catheter 1800, according to aspects of the present disclosure. Visible are the flexible elongate catheter body 645, pusher 646, and delivery lumen 1120. However, instead of individual foam plugs, the plug deployment catheter 1800 stores a length or cylinder 1810 of cuttable shape-memory foam plug material 1820 capable of forming a plurality of plugs. The plug deployment catheter also includes a cutting electrode 1830 operated by an electrical power source 1840 and / or an actuator 1850. When energized by the electrical source 1840 and / or actuated by the actuator 1850, the cutting electrode 1830 can cut a plug 1860 from the length or cylinder 1810 of foam plug material 1820.

[0123] Figure 18B is a diagrammatic, longitudinal cross-sectional view of the example plug deployment catheter 1800 of Figure 18 A, according to aspects of the present disclosure. Visible are the flexible elongate catheter body 645, pusher 646, delivery lumen 1120, the cylinder 1810 of foam material 1820, the cutting electrode 1830, electrical source 1840, actuator 1850, and foam plug 1860. In the example shown in Figure 18B, the cutting electrode 1830 has been withdrawn, allowing the plug 1860 to separate from the cylinder 1810 of foam material 1820. This may be done, for example, if the plug 1860 has already been placed and expanded into a paravalvular leak as described above, and needs to be separated from the plug deployment catheter 1800.

[0124] Figure 19 is a schematic diagram of a processor circuit 1950, according to aspects of the present disclosure. The processor circuit 1950 may be implemented in the processing system 610, the system 600, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as necessary to implement the method. As shown, the processor circuit 1950 may include a processor 1960, a memory 1964, and a communication module 1968. These elements may be in direct or indirect communication with each other, for example via one or more buses.

[0125] The processor 1960 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of general-purpose computing devices, reduced instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers. The processor 1960 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 1960 may also be implemented as acombination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0126] The memory 1964 may include a cache memory (e.g., a cache memory of the processor 1960), random access memory (RAM), magnetoresistive RAM (MRAM), readonly memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an embodiment, the memory 1964 includes a non-transitory computer-readable medium. The memory 1964 may store instructions 1966. The instructions 1966 may include instructions that, when executed by the processor 1960, cause the processor 1960 to perform the operations described herein. Instructions 1966 may also be referred to as code. The terms “instructions” and “code” should be interpreted broadly to include any type of computer- readable statement(s). For example, the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc. “Instructions” and “code” may include a single computer-readable statement or many computer-readable statements.

[0127] The communication module 1968 can include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 1950, and other processors or devices. In that regard, the communication module 1968 can be an input / output (I / O) device. In some instances, the communication module 1968 facilitates direct or indirect communication between various elements of the processor circuit 1950 and / or the system 600. The communication module 1968 may communicate within the processor circuit 1950 through numerous methods or protocols. Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI), Inter-Integrated Circuit (I2C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio, Incorporated 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol. Parallel protocols include but are not limited to Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a Universal Asynchronous Receiver Transmitter(UART), Universal Synchronous Receiver Transmitter (USART), or other appropriate subsystem.

[0128] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the leaflet puncture and slitting device) may be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G / GSM (global system for mobiles) , 3G / UMTS (universal mobile telecommunications system), 4G, long term evolution (LTE), WiMax, or 5G. For example, a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches. The controller may be configured to communicate with a remote server, or a local device such as a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. Information may also be transferred on physical media such as a USB flash drive or memory stick.

[0129] As will be readily appreciated by those having ordinary skill in the art after becoming familiar with the teachings herein, the paravalvular leak plugging device advantageously permits a clinician (e.g., a heart surgeon) to reversibly repair paravalvular leaks that may form during a valve replacement procedure. Although primarily intended for the repair of paravalvular leakage, the same technology could be applied to annul oplasty, e.g., if a patient already has a annuloplasty ring implanted. The same device could also be used as an embolic to treat aneurysmal disease in certain types of aneurysms.

[0130] Furthermore, although intended for specific treatment of heart valve related diseases, the technology disclosed herein could be expanded to anywhere tissue needs to be plugged to prevent leakage of body fluids.

[0131] The logical operations making up the aspects of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may be arranged or performed in any order, unless explicitly claimed otherwise or a specific order is inherently necessitated by the claim language. It should further be understood that the described technology may be employed in single-use and multi-use devices for medical or nonmedical use.

[0132] All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid thereader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of aspects of the present disclosure. Connection references, e.g., attached, coupled, connected, and joined are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other. The term “or” shall be interpreted to mean “and / or” rather than “exclusive or.” The word "comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. Unless otherwise noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

[0133] The above specification, examples and data provide a complete description of the structure and use of exemplary aspects of the present disclosure, e.g., as defined in the claims. Although various aspects of the claimed subject matter have been described above with a certain degree of particularity, or with reference to one or more individual aspects, those skilled in the art could make numerous alterations to the disclosed aspects without departing from the spirit or scope of the claimed subject matter.

[0134] Still other aspects are contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular aspects and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter as defined in the following claims.

Claims

CLAIMSWhat is claimed is:

1. An apparatus, comprising: a valvular plug configured to be positioned within a paravalvular leak inside a heart of a patient and adjacent to a prosthetic heart valve, the valvular plug comprising a proximal lobe, a distal lobe, and a waist extending between the proximal lobe and the distal lobe, wherein the proximal lobe, the distal lobe, and the waist comprise a foam configured to transition between a compressed state and an expanded state to contact native tissue of the heart and an outer perimeter of the prosthetic heart valve.

2. The apparatus of claim 1, wherein the foam defines an outer surface of the valvular plug.

3. The apparatus of claim 1, wherein the valvular plug comprises a dumbbell shape defined by the foam.

4. The apparatus of claim 1, wherein the foam, in the expanded state, is configured to conform to at least one of the native tissue of the heart or the outer perimeter of the prosthetic heart valve.

5. The apparatus of claim 1, wherein the foam comprises a shape memory foam configured to transition from the compressed state to the expanded state in response to a temperature inside the patient.

6. The apparatus of claim 1, wherein a length of the proximal lobe and a length of the distal lobe are greater than a length of the waist.

7. The apparatus of claim 1, wherein the valvular plug comprises a central longitudinal wire.

8. The apparatus of claim 7, wherein the foam of the proximal lobe, the distal lobe, and the waist surrounds the central longitudinal wire.

9. The apparatus of claim 1, wherein the valvular plug comprises only the foam.

10. The apparatus of claim 1, wherein the valvular plug comprises a radiopaque marker.

11. An apparatus comprising: a plurality of valvular plugs configured for deployment within one or more paravalvular leaks inside a heart of a patient and adjacent to a prosthetic heart valve; and a valvular plug delivery catheter comprising a lumen configured to receive the plurality of valvular plugs and hold the plurality of valvular plugs positioned proximate to one another inside the lumen, the valvular plug delivery catheter configured to be positioned within a body of a patient and to deploy the plurality of valvular plugs from the lumen while remaining positioned within the body of the patient.

12. The apparatus of claim 11, wherein: the lumen is sized and shaped to maintain the plurality of valvular plugs positioned inside the lumen in a compressed state, and each plug of the plurality of valvular plugs is configured to transition to an expanded state when the plug is deployed within the one or more paravalvular leaks.

13. The apparatus of claim 12, wherein the plurality of valvular plugs comprises a foam.

14. The apparatus of claim 11, wherein: the valvular plug delivery catheter further comprises a pusher rod positioned inside the lumen proximal to the plurality of valvular plugs, and the pusher rod is configured to be moved longitudinally to push the plurality of valvular plugs out of an open distal end of the lumen for deployment within the one or more paravalvular leaks.

15. The apparatus of claim 14, wherein: a second valvular plug of the plurality of valvular plugs is positionable between a first valvular plug of the plurality of valvular plugs and the pusher rod, and the pusher rod is configured to, when longitudinally moved, cause a distal end of the pusher rod to contact a proximal end of the second valvular plug, a distal end of the second valvular plug to contact a proximal end of the first valvular plug, and a distal end of the first valvular plug to advanced out of the open distal end of the lumen.

16. The apparatus of claim 11, wherein: the plurality of valvular plugs comprises a continuous length of material, and the valvular plug delivery catheter is configured to separate the continuous length of material into a first valvular plug and a second valvular plug.

17. An apparatus comprising: a valvular plug removal catheter comprising a tapered distal portion and a first lumen positioned proximal of the tapered distal portion, wherein the tapered distal portion is configured to receive a valvular plug in an expanded state, wherein the tapered distal portion comprises a decreasing diameter along a distal to proximal direction, wherein a wall of the tapered distal portion is configured to transition the valvular plug into a contracted state upon movement of the valvular plug in the distal to proximal direction such that the valvular plug in the contracted state is received within the lumen.

18. The apparatus of claim 17, wherein the valvular plug comprises a shape memory foam, wherein the valvular plug removal catheter comprises a second lumen proximate to tapered distal portion and comprising a liquid configured to cool the shape memory foam during the movement of the valvular plug in the distal to proximal direction.

19. The apparatus of claim 17, wherein the first lumen is configured for communication with a suction source configured to cause the movement of the valvular plug in the distal to proximal direction.

20. The apparatus of claim 17, further comprising a puller rod configured to be positioned within the first lumen, wherein the puller rod comprises a snare, wherein the valvular plug comprises an anchor configured to be engaged by the snare, and wherein movement of the puller rod in the distal to proximal direction is configured to cause the movement of the valvular plug in the distal to proximal direction.

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