WO2024259166A2 - Cardiovascular devices and methods - Google Patents

Abstract

A prosthetic aortic valve that uses actuating arms and grippers to attach to leaflets, reducing device migration and sizing issues. It involves excising diseased leaflets prior to implantation, ensuring blood flow to coronary arteries, and offers optical visualization. The valve features replaceable leaflets and a streamlined frame. Innovative left atrial appendage devices, embolic protection devices, intra-cardiac echocardiography devices, and steerable catheter devices are introduced. Provided herein are atraumatic, cinchable mitral valve annular repair devices, noninvasive methods that modify body calcium with electromagnetic energy, and systems for optical visualization in vascular interventions by displacing blood with clear fluid.

Description

CARDIOVASCULAR DEVICES AND METHODS

CROSS-REFERENCE

[0001] This application claims the benefit of US provisional patent application nos. 63/507,736, filed on June 13, 2023; 63/509,664 filed on June 22, 2023; 63/519,821 filed on Aug 15, 2023; 63/591,052 filed on Oct 17, 2023, 63/562,978, filed on March 8, 2024, and this application is also a continuation-in part of US non-provisional application no. 18/668,242, filed on May 19, 2024, which claims priority to US provisional patent application no. 63/503,427, filed May 19, 2023, the full disclosures of which are incorporated herein by reference.

BACKGROUND

[0002] Left Atrial Appendage Occlusion Devices and Methods:

[0003] This disclosure pertains to occlusion devices, specifically focusing on implantable devices intended for occluding a patient's left atrial appendage. Additionally, it encompasses methods related to the utilization and implantation of these occlusion devices.

[0004] Embolic Protection Devices and Methods:

[0005] This disclosure pertains to devices and methods for providing embolic protection in a patient’s vascular system. For example, the device may be deployed in a patient’s aorta to provide embolic protection to the aortic arch vessels and downstream organs. The device is capable of acute application, such as during cardiac surgery and interventional cardiology procedures, as well as potential implantation for ongoing chronic safeguarding against cardiogenic emboli or emboli stemming from ruptured or vulnerable aortic plaque.

[0006] Intra-Cardiac Echocardiography Devices and Methods:

[0007] The disclosure relates to intravascular ultrasound imaging, for example, ID, 2D, 3D, and 4D catheters. More specifically, the present disclosure pertains to an ultrasound intracardiac echocardiography (ICE) catheter with increased probe surface area to more clearly transmit ultrasound and receive echo in intracardiac diagnostics.

[0008] Novel Steerable Catheter Devices and Methods:

[0009] The present disclosure relates generally to medical methods, devices, and systems. More specifically, the present disclosure pertains to steerable catheters using pull wires and robotic devices.

[0010] Aortic Valve Devices and Methods:

[0011] The present disclosure relates generally to medical methods, devices, and systems to treat aortic heart valve. In particular, the present disclosure relates to methods, devices, and systems for the endovascular, percutaneous, or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair/replacement. More particularly, the present disclosure relates to methods and devices for the repair or replacement of aortic valve, however, these novelties may be applied to treat pulmonary, mitral, and tricuspid heart valves, venous valves, and other tissue structure through minimally invasive and other procedures, as obvious to Person of Ordinary Skill in the Art (POSA).

[0012] Mitral Valve Devices and Methods:

[0013] The present disclosure relates generally to medical methods, devices, and systems to treat mitral and tricuspid heart valves. In particular, the present disclosure relates to methods, devices, and systems for the endovascular, percutaneous, or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair/replacement. More particularly, the present disclosure relates to methods and devices for the repair or replacement of mitral valve, however, these novelties may be applied to treat pulmonary, aortic, and tricuspid heart valves, venous valves, and other tissue structure through minimally invasive and other procedures, as obvious to Person of Ordinary Skill in the Art (POSA).

[0014] Anti-Calcification Vascular Devices:

[0015] disclosure relates to generally medical methods, devices, and systems for the non- invasive, cutaneous, transcutaneous, endovascular, percutaneous, or minimally invasive surgical treatment of bodily tissues, to prevent or treat body, organ, tissue, and or vascular calcification. [0016] Visualization for Interventional Procedures:

[0017] disclosure relates to generally medical methods, devices, and systems for the non- invasive, cutaneous, transcutaneous, endovascular, percutaneous, or minimally invasive surgical treatment of bodily tissues, to prevent, diagnose, or treat tissue via direct visualization. More particularly, the present disclosure relates to methods and devices for vascular interventional procedures, to provide direct visualization of the blood vessel by displacing blood and or tissue, disclosure allows for direct visualization within the blood vessel and or beyond the blood vessel by displacing blood, tissue, bone marrow, puss, and or fluid. While exemplary embodiments and methods are taught, these novelties may be applied to treat vascular, cardiovascular, neurovascular, urological, gastrointestinal, orthopedic, pulmonary, spinal, brain, heart, muscle, kidney or any other organs and tissue structure obvious to Person of Ordinary Skill in the Art (POSA). Additionally, the methods and devices disclosed may be configured to be used in any other application, where optical visualization is hindered by largely opaque fluid, media, and or tissue. SUMMARY

[0018] Left Atrial Appendage Occlusion Devices and Methods:

[0019] The novelty of this device and/or method is a high compliance atraumatic frame that is implanted distal to the orifice of the LAA, farther into the LAA than the current standard of positioning (at or close to the orifice). This device and/or method disclosure provides LAA treatment and/or amelioration while a) preserving at least some LAA functionality, b) atraumatically yet securely implanting the device and preventing device migration or dislodgement, c) reducing peri-LAA leaks, d) reducing leaks around and/or from the device, e) providing an anatomy conforming device that adapts to larger variations in size and shape of the LAA, f) minimizing any adverse effect on electrical conduction pathways, g) minimizing or eliminating any trauma or encroachment of atrial real-estate, h) mitigating clot formation around the device, i) minimizing the duration for anti-clot drug therapy immediately post implantation, j) promoting more effective endothelization around the device, k) maximizing the retention of the functionality of the LAA and effectively trapping any clot inside, 1) allowing the occlusion device to be implanted under direct visual guidance, allowing to assess blood leaks indirectly by observing presence of blood in the flushed out saline, m) allowing implantation of smart devices isolated/secured by the occlusion device or in the occluded region of the LAA. Additional advantages allow for optional flushing of the occluded portion to further mitigate clot formation and the ensuing inflammatory reaction and/or allowing for diagnostic optical visualization of the trapped region. Other advantages include, without limitation, a higher level of compatibility with challenging anatomies that are incompatible with current devices requiring significant real estate in the left atrium space adjacent to the LAA; progressive volume reduction of trapped/occluded LAA; creating a safe space for implants such as defibrillators, stimulators, sensors, transducers, remotely operatable, wired and wireless smart devices; and significant time-saving opportunities from the use of a single implant that is less sensitive to the site of deployment or increased the region of implantation, thus requiring fewer needs for repositioning.

[0020] Embolic Protection Devices and Methods:

[0021] The disclosure provides methods, systems, and devices for filtering embolic debris, arising both from the procedure and from the placement and removal of the embolic protection device itself. An exemplary embodiment of an Embolic Protect Device comprising a filter body and a catheter shaft allowing for access to the aortic valve by device catheters without causing trauma to the access vessel wall and providing whole body protection by preventing emboli release into the aortic side branch vessels and downstream vessels. [0022] An exemplary embodiment comprises of a large introducer or catheter sheath through which one or more secondary device delivery catheters may pass through directly to the implantation site. Therefore, there is no need for multiple entry points through the femoral artery, drastically reducing risk of infection, complications, and healing and procedure time. This sheath may navigate the aortic arch, remaining central to the artery, and thereby, preventing dislodgment of the embolic debris on the sides of the artery. From this sheath, an embolic filter will be deployed, expanding radially, creating an atraumatic seal at the distal end of the device with minimal contact with the artery, and therefore less risk of emboli dislodgement.

[0023] Unlike common embolic protection devices, the disclosure does not deflect debris into a capture element, rather, it uses a filter to catch embolic debris made up of porous mesh material, such as a fabric, plastic, metal, or nitinol mesh/braid/sieve. In order to retain the integrity of the contact feature of the filter with the vessel wall, the segment of the filter connecting with the catheter will be flexible and sufficiently long to allow for wide range of the catheter movement. The surface area and pore size of the is large enough so filter does not create pressure loss of blood which needs to flow through important aortic side branches, while effectively capturing the debris. For example, deflectors as in prior art, can create this pressure loss, causing blood to bypass the side branches, or flow through them at a lower rate. The filter in disclosure is preferably placed in the ascending aorta, and may have a preferred pore size of 20-50 microns. Multiple (one or more) tissue contact seals may be implemented, along with manual or selfexpanding automatic seal, reducing risk of dislodgment.

[0024] In an exemplary embodiment, at the distal end of the filter, the filter expands to the size of the aorta diameter. A singular z-stent or spring wire, compression spring, coil, or a balloon may be used to better expand and seal the filter.

[0025] If a large amount of embolic debris is collected, the filter may be retrieved, or a vacuum or positive blood pressure may be used to suction or eject the debris in real time.

[0026] In an exemplary embodiment, the device has two or more seals, distal and proximal to the guide/sheath catheter shaft opening, and there is enough slack to allow for entrapment of the debris as well as small free movement of the catheter shaft opening between the seals (without dislodging or compromising the seals and/or abrading/dislodging the debris from the aortic lumen wall), while configured to allow for safe capture and retrieval of the debris at the end of the procedure and or removal/retrieval of the embolic device.

[0027] Although embodiments in the figures show primarily aortic valve procedures, the same may be applied for both aortic and mitral valve procedures, as the ascending aortic arch is downstream to both mitral and aortic valve. Similarly, these embodiments can be modified to be used for tricuspid and pulmonic valve applications by placing the filter immediately downstream to these valves. Similarly, these ideas in disclosure can be easily configured by POSA to be used in other procedures that have embolic risk, such as, carotid artery stenting.

[0028] Intra-Cardiac Echocardiography Devices and Methods:

[0029] The typical ICE catheter uses one transducer, which can fit within a 12 French catheter, limiting surface area. An advantage of this disclosure may be to increase surface area or size of the sensor/transducer. This creates a clearer and larger image of cardiac structures with increased resolution during the procedure, facilitating faster decision making and a more streamlined workflow.

[0030] The typical catheter probe is flat and limited to a 90 x 90 degree field view. An advantage of this disclosure may be to increasing this field of view by adding a curved, angled, or assembly or pairing of multiple probes in multiple directions, thus, reducing need for rotating the transducer tip, optimizing the position and orientation of the device, enabling the user to capture more of the heart views simultaneously at any point in time. An advantage of this disclosure may be to ability to perform multimodality imaging, A-Scan, B-Scan, M-Mode, C- Mode, Doppler, 3D, 4D, elastic modulus imaging, linear, curvilinear, phased array, transmission mode, reflection mode, backscatter mode, harmonic, sub-harmonic, ultraharmonic mode, continuous, pulsed, or combination, etc.

[0031] An advantage of this disclosure may be that two or more ICE catheters may be combined to provide improved image quality and or size.

[0032] Novel Steerable Catheter Devices and Methods:

[0033] The novel disclosure in this application allows for complete control of the catheter by using the functionalities of both the positive and negative side of pull-wires. The disclosure allows for new motions, such as enabling axial length adjustments, curving with greater stability via differential pulling on the pull wires, and superior control by applying tension in inward and opposing directions. The disclosure leverages the mechanical advantage of pully system to achieve superior isolation for segmented curving and/or exerting higher steerable forces in a specific segment of catheter while minimizing forces in other segments of the catheter.

[0034] Another advantage of this disclosure may be the use of a helical pattern to facilitate rotation of the catheter, with or with in combination with curved steering. In some embodiments, the disclosure may be combined with structural reinforcement along the catheter's length to configure selective segmental forces, all while using the same pull wire.

[0035] In some embodiments, nitinol motors or pneumatics, or fluidics are utilized to enable individual segment steerability or adjustments for curvature, length modification, and rotation. Additionally, the incorporation of motors and smart sensors enables robotic control, employing established industrial robotic techniques, applicable across medical and non-medical fields for precision and functionality improvements.

[0036] Aortic Valve Devices:

[0037] The majority of prosthetic devices used for valve replacement, such as those for the aortic valve, rely on compression against the anulus or the wall, demanding high stiffness or substantial expansion force. Additionally, these devices often need to be longer than necessary to prevent migration or placement errors. An advantageous aspect of this disclosurelies in its ability to grasp the leaflets, effectively reducing the risk of device migration and allowing for a smaller device size to secure it. Furthermore, disclosure teaches methods and embodiments that allow for cutting diseased native and/or prosthetic leaflets, including complete removal of prosthetic valve. It also teaches modular or insertable/replaceable prosthetic leaflets within a valve, disclosure also teaches means to enable blood flow to the coronary arteries during the valve replacement procedure, especially if the diseased leaflets are cut/removed. disclosure also teaches methods and embodiments for optical visualization during the valve replacement procedure.

[0038] Conventional prosthetic mechanical valves typically feature exposed bare metal that isn't intended to be covered by tissue, thus requiring ongoing use of blood thinners to prevent clotting. One key advantage of this disclosure may be its minimal or absent exposed bare metal surfaces that come into contact with blood flow. Furthermore, disclosure teaches mechanical valves with minimum or no moving metallic parts. Additionally, disclosure teaches methods and embodiments to deliver and implant using a catheter.

[0039] While the exemplary embodiments in this disclosure primarily focus on the aortic valve, the design concepts can be extended to encompass all heart valves (pulmonary, mitral, tricuspid, aortic), pulmonary valves, GI valves, and other applications evident to those skilled in the field. [0040] Mitral Valve Devices and Methods:

[0041] Exemplary embodiments describe herein, disclose methods and devices to cinch the annulus acutely (during the procedure) and also chronically (post procedure) using atraumatic anchors.

[0042] The disclosure also discloses prosthetic leaflet augmentation methods and devices wherein the leaflet augmentation feature is attached to the native leaflet and beats (or swivels) along with the native leaflets to better preserve/match physiological flow patterns.

[0043] The disclosure also discloses methods and devices that combine the atraumatic annular devices and the beating/ swiveling leaflet augmentation devices. [0044] Anti-Calcification Vascular Devices and Methods:

[0045] Similar to exemplary industrial water treatment devices such as iSpring ED2000, Yama CWD24, Yarna CWD48, Eddy, and Calmat that modify the nature of calcium and other mineral ions in home/office/commercial building plumbing, to reduce calcium deposits in pipes by the application of electromagnetic, electrical, magnetic, and/or light, disclosure teaches to apply techniques to modify the calcium and other mineral ions flowing in the body, to selectively or as a whole, modify and or prevent calcium deposits in the blood vessels, heart valve leaflets, tissues, or organs. In some embodiments, disclosure can be used to increase mineral deposits, for example, to increase calcium deposits in bones, to treat osteoporosis for example, and not limited to this example, as understood by POSA. As understood by POSA, these techniques can be used to either remove or prevent calcium deposit related diseases such as atherosclerosis non- invasively, interventionally, minimally invasively, surgically, or any combination thereof.

[0046] Hypothesis 1 : By applying similar electromagnetic pulses on the human body, it may be possible to mitigate or reverse calcified veins and arteries. It this hypothesis is true, then it can treat millions of patients suffering from vascular and valvular diseases.

[0047] Hypothesis 2: By keeping the calcium and other minerals in the blood, instead of depositing in the vessel lumens, more of these minerals are available to the body organs, such as bones and heart/muscles, thus potentially mitigating osteoporosis, and muscular diseases caused due to calcium deficiency.

[0048] This disclosure applies the above industrial solution to modify calcium minerals in water supply to regulate calcium mineral absorption in the body as well as descaling the blood vessels and heart valves.

[0049] An advantage of this disclosure may be to non-invasive and drug free regulation calcium in the body.

[0050] An advantage of this disclosure may be to safer disruption of calcified plaque by using directional or focused sonic/ultrasonic shockwave.

[0051] Visualization for Vascular Interventional Procedures:

[0052] Blood is essentially opaque and hence optical visualization is non-existent in vascular interventional procedures. CT scan, MRI, echography and fluoroscopy are available, however, availability of real-time optical visualization will significantly benefit the procedure. Hence, there exists a need to visualize blood vessels or heart valves similarly to open or invasive surgeries. [0053] An advantage of this disclosure lies in the ability to visualize blood vessels and heart structures using common optical cameras. This is achieved by locally displacing the blood and replacing it with clear fluid. For example, the clear fluid can be air or saline.

[0054] An advantage of this disclosure may be to optical visualization using techniques such as balloons, cones, and flush procedures.

[0055] Furthermore, disclosure enables optical visualization in a wide range of interventional procedures, where visualization is critical or desired. For example, optical visualization can be beneficial during procedures such as plaque disruption using stents, angioplasty, atherectomy, and valvuloplasty.

BRIEF DESCRIPTION OF DRAWINGS

[0056] FIG. 1 to FIG. 20 illustrates left atrial appendage closure devices and methods, in accordance with some embodiments;

[0057] FIG. 21 A to FIG. 28D illustrates embolic protection devices and methods, in accordance with some embodiments;

[0058] FIG. 29 A to FIG. 39D illustrates ICE devices and methods, in accordance with some embodiments;

[0059] FIG. 40 to FIG. 48F illustrates Novel Steerable Catheter devices and methods, in accordance with some embodiments;

[0060] FIG. 49A to FIG 79D illustrates aortic valve devices and methods, in accordance with some embodiments; and

[0061] FIG. 80A to FIG. 97 illustrates mitral valve annular repair, in accordance with some embodiments.

DETAILED DESCRIPTION

[0062] Left Atrial Appendage Occlusion Devices and Methods:

[0063] Left Atrial Appendage (LAA) or left auricle or auricula or left auricle appendix is a muscular pouch or windsock like structure projecting from the left atrium of the heart. During the disease pathology of atrial fibrillation (AF) or mitral valve disease or other heart conditions, or cardioversion, the contractility of the LAA is impaired and blood clots can form in the LAA. Such blood clots pose the risk of dislodging and becoming embolic material which may pose significant risks relating to stroke or other ischemic damage to the body's organs.

[0064] LAA occlusion is an alternative treatment strategy to blood clotting drugs or anticoagulants such as in the class of coumarin-type drugs, heparin-based drugs, small molecule inhibitor drugs, antithrombin protein-based drugs, and/or the like. Not all patients are suitable candidates for such blood clotting medicines due to underlying issues relating to prior bleeds, non-compliance, and/or pregnancy and are therefore in need of other treatment options such as the use of occlusion device strategies.

[0065] Current state of the art technology and methods generally comprise of completely occluding the LAA. The thought process revolves around the idea that LAA is redundant and has no or limited functionality.

[0066] Most current devices for LAA occlusion generally include an expandable nitinol frame or the like. Some of these are: for example in U.S. Pat. Nos. 5,025,060; 5,496,277; 5,928,260; 6,152, 144; 6,168,622; 6,221,086; 6,334,048; 6,419,686; 6,506, 204; 6,605,102; 6,589,256; 6,663,068; 6,669,721; 6,780,196; 7,044,134; 7,093,527; 7,128,073; 7,128,736; 7,152,605; 7,410,482; 7,722,641; 7,229,461; 7,410,482; 7,597,704; 7,695,488; 8,034,061; 8,080,032;

8,142,456; 8,261,648; 8,262,692; 8,361,138; 8,430,012; 8,454,633; 8,470,013; 8,500,751;

8,523,897; 8,535,343; 11,331,103; 11,331,104; 11,382,635; 11,419,611; 11,432,809;

11,589,873; 11,642,221; and 11,648,013; and United States Application Numbers 2003/0195553; 2004/0098027; 2006/0167494; 2006/0206199; 2007/0288083; 2008/0147100; 2008/0221600; 2010/0069948; 2011/0046658; 2012/0172973; 2012/0283768; 2012/0330341; 2013/0035712; 2013/0090682; 2013/0197622; 2013/0274868; 2014/0005714; 2022/02183561 2022/0313270; 2023/0031497; 2023/0032647; 2023/0052812; 2023/0071725; 2023/0079900;

2023/0084301; 2023/0084358; 2023/0121200; 2023/0129101; 2023/0130379; 2023/0145262;

2023/0146949; and 2023/0149072; European Application Number EP 1651117 and EP 3892240; and International Application Numbers WO13/028579; W013/109309;

WO13/152327; WO 2022/133088; WO 2023/062093; WO 2023/086285; WO 2023/086329;

US20230149072A1; WO2023086329A1; WO2023086285A1; US20230071725A1;

US20220370056A1; US20220313271 Al; US20220313270A1; US11432809B2;

US20220218356A1; US11382635B2; US11331104B2; US11331103B2; US11648013B2;

US20230146949A1; US20230145262A1; US20230130379A1; US20230129101A1;

W02023062093A1; US20230084301A1; US20230079900A1; US11589873B2; EP3892240B1;

US20230052812A1; EP4129210A1; US20230032647A1; US20230031497A1; and

US11419611B2. While the use of such devices results in less hemorrhagic stroke than with anticoagulants alone, there are known disadvantages and limitations such as, without limitation, pericardial effusion, partial LAA closure, dislodgement of the device, blood clot formation on the device, anatomical incompatibilities and/or a combination thereof. Furthermore, the above LAA occlusion device treatment devices and related methods myopically focus on mitigation of the thrombus only, with a general belief that LAA has limited functionality or is a redundant organ or becomes redundant once its contractility is impaired.

[0067] This is a gross misunderstanding, as LAA performs an important function analogous to a surge tank (like a capacitor). More so, as left atrium and left ventricle are two separate pumps in series, operating at different pressures and slightly out of sequence (typically, the atrium contraction initiates before the ventricular contraction). Further, the ejection and filling rate vary throughout the cycle of the heart between the two. The LAA performs the vital function of compensating for the blood flow/volume variation/mismatch/surge between the atrium and ventricle.

[0068] Accordingly, there is a need for improved occlusion devices and methods in the field that at least partially retain the vital functionality of the LAA, while minimizing the previously mentioned risks, such as thromboembolism, device migration, effusion, leaks, etc.

[0069] Embolic Protection Devices and Methods:

[0070] In navigating a catheter through a patient’s aortic arch in various endovascular procedures, embolic debris may inadvertently become dislodged, causing mild to severe cardiovascular complications, leading to stroke, organ failure, and even death. In general, embolic protection devices either capture or redirect embolic debris to areas of lower risk. Typically, devices that remove emboli include stents or braided wire meshes that have large contact area with the aortic wall, and in some embodiments, covering almost the entirety of the aortic arch and significant portion of descending aorta. This presents the risks of releasing large amounts embolic debris during the removal/retrieval of the embolic protection device, as it disengages/drags across the aorta.

[0071] Therefore, there is need for improved embolic devices and methods that minimize the embolic debris risks not only during the procedure, but also during removal/retrieval of the embolic protection devices themselves. Similar solutions are needed other central and peripheral endovascular procedures, for example and not limited to these examples, jugular artery stenting, aneurism treatment devices.

[0072] Intra-Cardiac Echocardiography Devices and Methods:

[0073] The current 4D Intra-Cardiac Echocardiography (ICE) catheters produce reasonable quality 3D moving images. However, in order to be small enough to be inserted into the heart chambers without general anesthesia, for example, via jugular or femoral vein or artery access, the catheter size is limited by the vascular size, which in turn limits the size and surface area of transducer or probe. This limits the quality and size of the image from within the heart. ICE catheter images are thereby much inferior to the TEE (Trans-Esophageal Echography) catheters that have much larger transducer/probe size or surface area.

[0074] Hence, there is a need for a way to introduce larger surface area probes (transducers, emitters, sensors, arrays or combination) or assemble more than 1 smaller size probe to create a super array of probes that collectively provide larger surface area or view zones or methods of imaging, to improve the overall quality of imaging, field of view, multiple views, diagnosis, and better aid in treatment.

[0075] Novel Steerable Catheter Devices and Methods:

[0076] Current steerable catheters rely predominantly on simple pull-wire manipulations for steering. However, this method becomes suboptimal as catheter size and complexity increase, resulting in a) increased pull wire forces and b) controlling/directing the region/ segment of the catheter where the pull forces are needed. Two primary issues arise: firstly, increasing the pull force necessitates enlarging the pull wire diameter or number of pull wire strands, subsequently increasing the pull wire lumen size and ultimately the catheter's outer diameter (OD) for a given lumen size. Secondly, in a multi segmented catheter, selectively steering the distal-most segments results in tension being transmitted along all its proximal segments, inadvertently causing them (proximal segments) to bend or steer too. Attempts to counter this involve reinforcing, stiffening, or steering the proximal segments differently, but even with laser cut tubing, optimal results aren't achieved — especially when multiple proximal and distal segments steer in the same direction. Therefore, there's a pressing need for a) improved isolation of steering between segments, b) a method to deliver higher forces to a selected segment while minimizing its impact/forces on the proximal segments, and c) a means to increase tension in the selected segment without escalating tension in the proximal (or distal) segments, all while reducing or maintaining the size of the pull wire.

[0077] Aortic Valve Devices and Methods:

[0078] Atraumatic aortic valves: Most prosthetic devices used for heart valve replacement, such as those designed for the aortic valve, are held in place by compressing against the anulus or the wall to mitigate perivalvular leaks and device migration. To achieve this, these devices need to be highly rigid or apply significant expansion force, often necessitating larger dimensions in terms of both length and diameter to minimize the risk of migration. However, the increased size, stiffness, and length of these devices can negatively impact the surrounding anatomy and blood interactions, potentially leading to issues like heightened stress points, deformations, restricted blood flow (ischemia), tissue death (necrosis), and other complications. [0079] Actuatable arms for secure positioning: Alternative devices, like the Jenavalve are capable of engaging with the leaflet, primarily for positioning purposes. Other examples, such as and US 10,925,724 B2 engage with the leaflets, however, in order to engage or disengage with the leaflets, manipulation of prosthetic valve is required. That is, in all of these devices, the leaflet capture elements lack the ability to be independently actuated (for example, without disturbing the main body of the prosthetic valve) to securely grasp or ungrasp the leaflets.

[0006] Spacer and or flap devices: In some cases, there is regurgitation in aortic valve, as there is a gap between the leaflets. This can happen due to stiffening, tears, and other disease conditions. In these cases, there is a need for a simple spacer or flap devices that can effectively and functionally seal the regurgitation. This solution/treatment can be a temporary, semipermanent, or permanent solution. Temporary or semi-permanent solutions are typically a bridge to a more permanent solution, such as total valve replacement.

[0080] Leaflet replacement: The typical lifespan of most prosthetic tissue valves ranges from 5 to 15 years. The current advanced transcatheter procedure involves deploying a new prosthetic valve within the failed tissue valve. However, the limited space between the calcified native valve and the failed prosthetic valve poses a challenge, resulting in restricted blood flow upon the insertion of a second valve. Consequently, there arises a necessity to either trim the leaflets of the failed prosthetic valve or completely remove the failed prosthetic valve in order to create adequate space for the new prosthetic valve to function effectively.

[0081] Leaflet shape and attachment: Native leaflets of the aortic valve are attached at the base of annulus and seat below or at the annulus. However, in current prosthetic heart valves, the prosthetic leaflets are supported along the height of the prosthetic valve frame and seat above the annulus. This results in hemodynamics flow patterns and stresses that are different from natural physiological flow patterns. Hence, there is a need to better mimic the natural flow patterns by developing prosthetic valves that better resemble natural leaflet structures.

[0082] Flow management: Aortic valve is a critical high pressure heart valve and any procedure performed on the valve can disrupt the flow downstream, including to the heart itself. Hence, there is need for methods and devices that can maintain flow and pressure, including providing embolic protection during and or after the procedure.

[0083] Leaflet Augmentation: Current devices focus primarily on valve replacement. However, disclosure discloses methods and devices to perform valve repair via leaflet augmentation, prior to resorting to valve replacement in the future.

[0084] Mechanical valves boast a lengthy lifespan of over 20 years but necessitate ongoing blood thinner usage. Therefore, there's a pressing need to enhance the hemocompatibility of these mechanical valves. Additionally, there's a demand for the transcatheter placement of mechanical valves to further improve their accessibility and application in medical procedures. [0085] Mitral Valve Devices and Methods:

[0086] Atraumatic Annulus Devices and Methods: The current state of the art transcatheter treatment for mitral valve regurgitation is edge-to-edge repair. However, there's potential for enhanced outcomes through a viable transcatheter annular reduction approach. Present solutions for annular reduction involve the insertion of multiple screws/anchors into the annulus, which not only heightens the risk of injury but also complicates the procedure excessively. Moreover, conducting annular reduction during the procedure can lead to tearing or tissue trauma by the screws/anchors, escalating the risk of arrhythmias and making it an impractical solution.

Therefore, there's a necessity for an atraumatic transcatheter annular repair device. Additionally, it would be preferable if this device could be adjusted post-implantation or auto cinch to optimize its effectiveness by encouraging reverse remodeling the heart.

[0087] Leaflet Augmentation Devices and Methods: The current state of art for leaflet augmentation prop up the leaflets from ventricular side as in US20230040083A1 or support it from atrial side as in EP 3912595B1. The prosthetic leaflet augmentation features of these current devices do not swivel or beat along with the native leaflets. This can alter the natural flow pattern. Hence, there is a need for swiveling prosthetic leaflet augmentation device that beats along with the native leaflets and enables natural flow pattern.

[0088] Anti-Calcification Vascular Devices and Methods:

[0089] Coronary artery atherosclerosis, aortic heart valve calcification, kidney and bile stones are several examples of calcium deposits in body that create unhealthy conditions and diseases. On the other hand, loss of calcium from bones also causes diseases such as osteoporosis. Most interventional treatments and invasive treatments are not without risks or are not very effective in addressing the disease. For example, stents only treat local disease sites and do not prevent from the occlusions occurring at other vessels. Medical therapy is not always effective nor can it reverse atherosclerosis. Hence, there is a need for alternate treatment means to address these issues. Preferably, non-invasive means to impart selective tissue or whole-body treatment.

[0090] Industrial electronic salt-free systems such as i Spring ED2000, Yama CWD24, Yarna CWD48, Eddy, Calmat, Scaleblaster SB-Elite use capacitance, magnetic, eddy current, or electromagnetic pulse, electromagnetic impulse and or continuous electromagnetic energy is used in the home/office pipes to prevent calcium deposits, sediments, precipitations, or limescales. They claim to work by altering the adhesion properties of the limescale so that it no longer deposits itself on your clean surfaces, inside pipework and appliances. The product does NOT alter the chemical hardness (TDS) of the water, so the beneficial effects of the calcium and other minerals is retained. These products claim to not only mitigate precipitation of calcium scales in the pipes, but they also dissolve any previous scales, thus, improving the lumen size of the pipes in thereby the flow through them. Most of these technologies work on wrapping wire over (outside diameter) the water pipe, similar to a solenoid winding, at least once. Typically 2 or more such windings are used with a small space between two windings.

[0091] For example, the ED2000 website claims that it functions by wrapping two antenna cables around the main water pipe to form a coil, creating a complex, frequency modulated, electronic magnetic waveform. This induces an oscillating electric field into the water, resulting in the agitation of water molecules sufficient enough to trigger the release of carbon dioxide and cause the premature precipitation of calcium bicarbonate. This process naturally results in a small increase in solubility, which allows the now unsaturated water to dissolve existing scale deposits and remove them from the water system.

[0092] In another example, Yama CWD24 is an alternate water softener for homes that treats water with electric pulses generated within the electronic unit and controlled by a micro-chip. These pulses are transmitted via our Ultra Flat Impulse Bands which breakdown crystals that would otherwise buildup into limescale, which can break appliances.

[0093] In another example, the Calmat website describes an exclusive Electric-Impulse- Technology which is based on the principle of physical water treatment; changing the crystallization process of the liquid calcium and this way the hard scale loses its adhesive power. Calmat works independently from the water velocity like other systems that use magnetic fields do. Calmat is suitable for all pipe materials.

[0094] One another method to disrupt calcium plaque is using ultrasonic shock waves. However, these shock waves are not directional, thereby requiring higher energy, which can result in safety concerns.

[0095] Visualization for Interventional Procedures:

[0096] Endoscopic and invasive surgical procedures have the advantage of real-time optical visualization, in addition to echographic and fluoroscopic visualization. For example, minimally invasive endoscopic or interventional endoscopic procedures inflate the site with gas or clear fluid, thereby, able to see via optical camera or direct visualization. However, in vascular interventions, the presence of blood essentially excludes this option of optical visualization. Hence, most of the current procedures are performed under echographic or fluoroscopic guidance. Hence, there is a need to enable optical visualization as an added modality/tool when performing catheter based vascular interventions. [0097] Left Atrial Appendage Occlusion Devices and Methods:

[0098] FIG. l is a block diagram of a part of the heart without any devices implanted, labelling the left atrial appendage (LAA), orifice (ORI), and the left atrium (LA).

[0099] FIG. 2A is a simplified diagram of the left atrial appendage with chicken wing morphology.

[0100] FIG. 2B is a simplified diagram of the left atrial appendage with windsock morphology. [0101] FIG. 2C is a simplified diagram of the left atrial appendage with broccoli morphology. [0102] FIGs. 3A-3D show schematic diagram of three different configurations of a left trial appendage closure device. FIG. 3A is an example of the device in the form of a single structure closure device 10. FIG. 3B shows an alternate 2-part closure device 20, wherein the body 26 holds a proximal covering disk 22 held in place by a connector 24 to connect them. FIG. 3C shows an alternate form of the closure device 30, where a disk 36 is held in place with one or more anchors 38. FIG. 3D show some examples of prior art closure devices.

[0103] FIG. 4A shows the placement of the closure device 10, shown in FIG. 3A in the block diagram of the heart, as in prior art examples where the LAA’s orifice is sealed. FIG. 4B shows an example of closure device 10 implanted in a schematic of LAA with chicken wing configuration.

[0104] FIG. 5A shows the placement of the closure device 20 in FIG. 3B in a block diagram of heart. FIG. 5B shows an example of the closure device 20 implanted in a schematic of LAA with windsock configuration, as in prior art examples where the LAA’s orifice is sealed.

[0105] FIG. 6A shows an example placement of the closure device 30 in FIG. 3C in a block diagram of heart. FIG. 6B shows an example of LAA closure device 30 implanted in a schematic of LAA with a broccoli configuration, in reference to current state of art, wherein, the LAA is intended to be sealed about the orifice.

[0106] FIG. 7A shows an exemplary embodiment (device and/or method) of disclosure, showing the positioning of a left atrial appendage closure device 10 placed behind the anulus ORI, towards the distal end of the LAA. FIG. 7B shows an example of the LAA closure device 10 implanted in a schematic of LAA with a chicken wing configuration. This advantageously allows for some function of the left atrial appendage as a decompression/surge chamber to be retained and a decreased chance of dislodgement as less pressure is exerted from heart contractions. Further, by placing it distal to the orifice, the risk of dislodgement is significantly mitigated. Hence, the LAA closure device can additionally be configured to have higher compliance and or less traumatic anchors than prior art devices, to advantageously avoid tissue trauma. The stent may be shaped like a cylinder, a cone, a cup, umbrella, or a sphere, and may be placed further distal to the orifice D, depending on the physiological constraints of the LAA. [0107] FIG. 8A shows an exemplary embodiment (device and/or method) of disclosure, showing a LAA closure device 20 placed behind the ORI, towards the distal end of the LAA. FIG. 8B shows an example of a LAA closure device 20 implanted in a schematic of LAA with a windsock configuration.

[0108] FIG. 9A shows an exemplary embodiment (device and/or method) of disclosure, showing a LAA closure device 30 with a single anchor 38, placed behind the anulus ORI, towards the distal end of the LAA. FIG. 9B shows an example of the LAA closure device 30 implanted in a schematic of LAA with a broccoli configuration.

[0109] FIG. 10 shows an exemplary embodiment of FIG. 7A, additionally comprising of a sponge, foam, beads, fabric, balloon, and or artificial tissue 52, used as a spacer to fill the cavity formed by the closure of the LAA.

[0110] FIG. 11 shows an exemplary embodiment of FIG. 7B, additionally comprising of a device/feature 63, added within the sealed portion of the LAA. This component 63 may be a defibrillator, a stimulator, a sensor, a transducer, drug delivery system, or a remotely operatable or wired and or wireless smart device, for example, those used for long term patent monitoring, drug delivery, biomarker, and or therapeutic device.

[0111] FIG. 12 shows an exemplary embodiment of FIG. 11, the device/feature 63 is optionally embedded inside a feature 73, wherein, the feature 73 is removable, replaceable, refillable, rechargeable compartment and or pouch that can be placed either inside or outside and or partially outside of the device 10.

[0112] FIG. 13. Shows a method of implanting device 10 under indirect visual guidance, by observing the flushed-out saline for presence/leaks of blood. A catheter sheath 102 used to comprise of first tubing 104 to flush saline into the orifice and second tubing 108 to suction fluid out of the orifice. In an alternate embodiment, direct visualization can be achieved by using a catheter-based camera, as known to POSA.

[0113] FIG. 14. Shows an alternate embodiment/method of FIG. 13, wherein, a senser 63 can be used for non-visual sensing of the presence of blood or visualizing presence of blood leaks.

[0114] FIG. 15 Shows a method of implanting the embodiment/method as shown in FIG. 14, using a temporary seal 118 to isolate the LAA from blood circulation, so the isolated segment can be flushed clear with saline both proximal and distal to the body 10, to enable direct visualization (optical, echo, infrared, etc), alternatively using sensor (example, a camera) 63, as to allow the device to be implanted under direct visualization. [0115] FIG. 16. Shows a method of implanting device in 14 using a temporary seal 118 to isolate the entire LAA from the blood circulation, including the Orifice of LAA, so the LAA can be flushed clear with saline to enable direct visualization of the entire or partial LAA using sensor (example, a catheter based steerable camera). Thus, allowing the device to be implanted under direct visualization.

[0116] FIG. 17 shows an LAA occlusion device 130, that additionally comprises of a one-way valve. The valve allows the LAA to be filled with blood pressure that is same as the max pressure (P3) that the left atrium (P2) sees. In an alternate embodiment, the direction of the oneway valve may be reversed, that is, to allow the flow out of the LAA, thereby progressively reducing the volume of the LAA and cause it to shrink in size, acutely or over an extended period of time. In an alternated embodiment, the device 130 comprises of a check valve, pressure regulator feature. In an alternate embodiment, the device 130 has a resealable section to allow passage of needles, tubes, light, fluid, catheter, etc through the body 130.

[0117] FIG. 18 shows an exemplary embodiment of occlusion device 130, which comprises of, for example and not limited to these examples, a bellow, diaphragm, springs, cone, sponge, film, or mesh/sieve. Optionally, a feature 140 may be added to enhance the surge tank function, LAA function, or mitigation of thrombus formation. The feature 140 may be saline, balloon, gel, sponge, spring, mesh, coil, braid, fabric, or vacuum.

[0118] FIG. 19 describes an exemplary method of deploying the current disclosure embodiments relying on user/surgeon skills and general/available imaging modalities, for example, ultrasound and fluoroscopy.

[0119] FIG. 20 describes an exemplary method of deploying the current disclosure embodiments that augments the method in FIG. 19, via computational Finite Element Analysis, Fluid Dynamics, optical tomography, current imaging modalities, and or artificial intelligence, to determine the optimal size or shape of the LAA occlusion device and the placement site of the LAA occlusion device that maximizes the retention of LAA function while minimizing the risk of embolism, leaks, device migration.

[0120] Embolic Protection Devices and Methods:

[0121] Fig. 21A shows an example embolic protection device in a schematic of an aorta. The device comprises of a filter 300, having an expandable and sealing distal end 310 that is configured to seal against the aortic wall and a proximal end 312 that is attached to the distal end of the catheter sheath 314. The sheath 314 and the filter 300 are configured to allow Aortic repair or replacement device to pass through it. Furthermore, the embolic protection filter 300 is configured to allow for small movements of catheter sheath 314, without dislodging or compromising the seal 310 or the aortic wall.

[0122] FIG. 21B shows FIG. 21A translated to a simpler block diagram. The distal end of the device has a seal 310 that approximates and seal to the aortic wall, while 312 is the proximal end of the filter that is attached to the catheter sheath 314, and 316 is an exemplary aortic valve replacement device passing through the sheath 314. The filter forms a seal on the walls of the aorta away from the aortic side branches, not disrupting the side walls of the aorta when the delivery device or catheter is passed through the filter catheter sheath, reducing risk of dislodging embolic debris. The device delivery catheter may enter through the filter catheter sheath, removing need for another opening through femoral access, performing the needed procedure on the aortic valve. Any dislodged embolic debris will then be captured by the filter as blood flows towards it, filtered blood will be able to pass through to the aortic branches or other body parts during the procedure.

[0123] FIG. 22A-D shows the procedure/method for deploying an exemplary of the embolic protection device. FIG. 22A shows a dilator 320 aided by a guidewire 322. The Guidewire 322 is first inserted and the dilator along with catheter 314 and filter 300 is advanced over the guidewire 322. FIG. 22B shows the guidewire being removed and the dilator 320 is then advanced to expose the filter 300. The distal ring 310 is then actuated/released to open radially and forms one (or more seals) 310. FIG. 22C shows the dilator being retracted back and removed. FIG. 22D shows the aortic valve repair/replacement device catheter 316 being advanced through the sheath 314 and filter 300 to perform the necessary procedure at the aortic valve. The filter body 300 will catch any embolic debris as the blood flows towards it, and the seal is configured to not be jostled or dislodged as the filter body 300 is made with a flexible/supple material which will bend with movement of the sheath 314 or catheter 316. [0124] FIG. 23 an alternate embodiment shown in FIG. 22, wherein, the filter body 330 comprises of a spiral wire 332 made of nitinol or any biocompatible material around the flexible filter 330 to aid in removal of the filter body by keeping the fabric larger in diameter to the filter catheter sheath 314 and smaller in diameter of the aorta.

[0125] FIG. 24 shows an alternate embodiment, wherein, the filter body 340 comprises of a nitinol shape-set mesh/braid with an inverted valve structure that is optionally retractable into a straight tube.

[0126] FIG. 25 shows how a doctor can push the distal end of the catheter sheath 352 forward to where the sheath 352 can be all the way through the filter distal seal 354. Allowing for multiple filter seals such as the intermediate seal 350 alongside the flexible filter mesh allow for the aortic device catheter 316 and filter catheter sheath 314 to be moved closer to the deployment site or jostled without dislodgment of the filter seals, preventing and mitigating emboli displacement.

[0127] FIG. 26A-C shows the procedure/method for removing the embolic protection device with exemplary multiple seals after the procedure with the aortic valve device is completed. FIG. 26A shows how after the aortic valve device procedure is complete, the embolic debris 360 is trapped within the embolic filter 362 and the aortic device delivery catheter 316 is removed. The preferred way to remove the filter is cinching the distal most seal 354, for example, using a cinch wire, deflating balloon, suture, spring, or other known means of sealing the debris within the filter. Next, FIG. 26B shows the distal seal 354 and portion of the filter body 362 is optionally being pulled into the intermediate seal 350 portion of the filter body with use of a wire, spring, suction, or other apparatus. Then the next intermediate seal 350 will be cinched, creating a smaller area/volume that the filter body will take up with the debris 360 securely entrapped in the filter 362. The step in FIG. 26B may be repeated if more intermediate seals are used for the embolic filter device. This way, the filter body 362 with the embolic debris 360 trapped within it will be more manageable/secure when being pulled either into or close to the filter catheter in removal. This reduces the risk of the filter brushing against the aortic walls and dislodging embolic debris or the filter getting stuck when the device is removed. The procedure also makes certain that the embolic debris within the filter has no way to flow out of the filter. A spiral spring like in FIG. 23 may also be used to contain filter 362. FIG. 26C shows the filter catheter then being pulled back with the compact filter body and debris in tow or within the catheter. Alternatively, a suction may be added to suck embolic debris 360 out of the filter 362 before removal of the filter 362 and catheter sheath 314, or may be used to suck/retract the entire filter body 362 back into the catheter sheath 314.

[0128] FIG. 27A-D shows an alternate exemplary embodiment/method to use the device in areas such as the carotid artery, where the blood flow is opposite to that of the iterations shown before in FIG. 26A-C. The filter catheter sheath 370 may move forward to where the distal end of the catheter sheath 372 is through the intermediate filter distal seal 374, as in FIG. 27B. The distal end of the sheath 372 may move forward to anywhere where between the intermediate seal 372 and the distal seal 374, without affecting the integrity of the seals 374, 372. This allows the physician to safely translate the balloon/stent over plaque 385, as in FIG. 27C. The balloon stent (77) may be positioned deflated and then expanded to crush the plaque to clear blockage, as shown in FIG. 27D. In an alternate embodiment/method is shown in FIG. 27D, wherein, the distal end of the sheath can be advanced beyond the distal seal 374. Any embolic debris 390 that may be released during expansion of the balloon/stent 382 over the plaque 385 will be caught between the folds of the embolic filter 380.

[0129] Fig. 28A shows an alternate embodiment catheter sheath 370 shown in FIG. 27D, wherein, the sheath 370 comprises of flow diversion holes 415 that allow for continued blood flow when the balloon/stent 382 is expanded and blocking off blood flow external to the sheath 370, to crush the plaque. These holes can be large to not get clogged or multiple holes may be used. Additionally, balloon/stent 382 may have channels to allow for blood flow and reduce pressure changes as well. FIG. 28B shows how after expanding, the balloon/stent 382 should be deflated for the removal process. The preferred exemplary way to capture the emboli 390 and remove the filter 380 and sheath 370 out is to cinch the intermediate seal 376 first, as seen in FIG. 28C, trapping the debris 390. FIG. 28D shows next step where the distal seal 374 is cinched to make the entire device more compact for removal. However, the seals 374, 376 may be cinched in the opposite order with a similar outcome as blood flow prevents the embolic debris 390 from moving in the other direction. The cinched rings may be outside or retrieved inside the catheter sheath 370 and finally, the entire embolic protection catheter can be removed. [0130] Intra-Cardiac Echocardiography Devices and Methods:

[0131] FIG. 29A shows a cross-sectional view of the ICE catheter with a flexible probe 610 in a curved position the inside of the catheter 612. The probe can be made of an elastic/bendable/superelastic/film/stretchable/flexible material configured to be straight and flat when deployed, but can be folded or bent in curved position by tension applying feature 616, which can be a suture, wire, balloon, and or mechanical lever. In FIG. 29B, the probe is unfolded by release of tension or by pushing or releasing feature 616 from the proximal end of the catheter as seen in FIG. 29C. The side view of FIG. 29A can be seen in FIG. 29C. The side view of FIG. 29B can be seen in FIG. 29D. In an alternate embodiment, the ICE probe/transducer can also be configured to be curved at rest and can be biased into straight position by application of energy or a biasing force.

[0132] FIG. 30A-B to FIG. 33A-D show alternate exemplary embodiments of the ICE devices. [0133] FIG. 30A shows a cross-sectional view of the ICE catheter with rigid probes 620 and 621 in a V-formation inside the catheter, while FIG. 30B show flattened probes 620 and 621 in a single plane. Similarly, FIG. 31A-B shows example of square configuration, FIG. 32A-B shows example of U channel configuration, and FIG. 33A-D shows example of an ‘I’ configuration, where two probes 650, 651 are configured side-by-side with an hinge/connector, to expand in a configuration shown in FIG. 33B. FIG 33C shows an alternate exemplary embodiment of probes 661, 662, 663 in I or parallel configuration while inside the catheter 665, while FIG. 33D shows the probes 661, 662, 663, sliding into their fully expanded state. In an alternate embodiment of any of the probes 661, 662, and/or 663 themselves can be individually expandable/stretchable in single direction (ID) or multiple directions (2D, 3D, and or 4D -with time as 4^th dimension).

[0134] In alternate exemplary embodiments, all the ICE device examples shown in FIG. 29A-D to FIG. 33A-D can be configured to be operated at any position (constrained inside the catheter 612 to fully expanded/deployed position or in any position in between). Furthermore, the probes may be assembled in a plane, curve, or any 3D and/or 4D shape.

[0135] FIG. 34A-D shows exemplary embodiment/method of multiple rigid probes 660, 661, 662, and 663 that can be assembled/positioned into a flower or cross like position. FIG. 34A- 34D show an example of progression of probe orientations/assembly. These probes may be moved by pullies, sutures, magnets, hinges, hooks, actuators, motors, and/or fluidics. In an alternate embodiment, there may be a greater than 1 probe or less than 1,000,000 probes.

[0136] FIG. 35A-C shows an exemplary embodiment of alternate pattern of probe assembly, wherein, the probes are assembled side-to-side (besides/adjacent to each other).

[0137] FIG. 36A shows an alternate embodiment of Figure 34D, where the probes are folded when first positioned, and unfolded as seen in FIG. 36B to increase surface area in the final orientation.

[0138] FIG. 37A-E shows an alternate positioning system to FIG. 34A-D, where the probes are placed adjacent to one another, in a fan formation. There can be as many or as few probes as needed used in the device. FIG. 37A to 37E show the progression of the probes positioned/arraigned outside of the catheter 695. The probes 690, 691, 692, 693, 694 can be arranged in any order/sequence.

[0139] FIG. 38A-F shows an alternate shape for probes, where the probes are shaped like wedges that are pieced together as seen in FIG. 38F. There can be as many or as little probes as needed used in the device, and the probe pieces may be shaped in any way that may allow them to fit together.

[0140] FIG. 39A shows a train of probes, with flexible joints inside the catheter, to allow for catheter flexibility, yet allow for increased area.

[0141] FIG. 39B, FIG. 39C, and FIG. 39D show exemplary schematic of various configurations of the final assembly of the probes.

[0142] In all of the ICE catheter embodiments described in this application, the probes can be functional while inside the catheter and/or when assembled outside the catheter. Further, in an alternate embodiment, any of the ICE catheter with probes described in this application, can be steerable. Further, in an alternate embodiment, two or more ICE catheters with probes can be stacked or assembled together inside the patient, outside the patient, partially inside and partially outside the patient. The mode of assembly can be using electromagnets, magnets, puzzle locks, sutures, strings, wires, keys, motors, hinges, superelastic joints, bendable/flexible joints, mechanical joints, chemical joints, and/or any method known to the POSA.

[0143] Novel Steerable Catheter Devices and Methods:

[0144] FIG. 40 shows an exemplary principle of a compression spring, wherein, L0 is the initial uncompressed length, Ln is fully compressed length, and LI, L2 are progressively shorter lengths. F0 = 0 units of force and Fn is the maximum compressive force needed to fully compress the spring to Ln. Note, instead of applying force, the same can be achieved by applying a said displacement on the pull wire, to cycle its length, as is commonly known to POSA.

[0145] FIG. 41 shows the current way of steering, wherein, two pull wires 801, 802 are diagonally opposite sides along the length of the steerable catheter shaft. Pulling a pull wire 802 on one side with force Fl, while the other 801 is relaxed, causes the elastic steerable segment of the catheter to compress to LI, thereby resulting in the steerable catheter to curve in that side. To straighten, the pulled pull wire is relaxed to F0, and the catheter straightens to L0.

[0146] FIG. 42A-E. Shows an exemplary principle of disclosure. FIG. 42A shows the catheter in relaxed state.

[0147] FIG. 42B shows an exemplary method wherein the catheter shaft is compressed to Ln by applying Fn forces on both side pull wires. This is new initial state, which can be achieved while the catheter is fully or partially inserted in the body or when the catheter is on the table.

[0148] FIG. 42C shows curving by relaxing convex side from Ln to L2.

[0149] FIG. 42D shows further curving by relaxing the convex side from L2 to LI, while maintaining the concave side at Ln.

[0150] FIG. 42E shows net elongation by relaxing the pull wires, while maintaining slight curving.

[0151] FIG. 43A-D describes the principle of mechanical advantage using a pully principle. [0152] FIG. 43A shows a simple single pulley 805 with mechanical advantage (MA) = 1. [0153] FIG. 43B shows a double pulley configuration with a mechanical advantage (MA) = 2. [0154] FIG. 43C shows a triple pulley configuration with a mechanical advantage (MA) = 3. [0155] FIG. 43D shows an exemplary quadruple pulley configuration with a mechanical advantage (MA) = 4.

[0156] FIG. 44A shows current/typical catheter with mechanical advantage (MA) = 1. In this configuration, all segments of the catheter experience the same pull force. [0157] FIG. 44B shows an exemplary embodiments of disclosure, configured with a mechanical advantage (MA) = 4 in the distal segment S2, while the proximal segment SI sees a lower MA of 1.

[0158] FIG. 45A and 45B show exemplary embodiments, configured with various MA to curve in various segments or directions. In addition, it introduces the concept of MA=0 by having a compression coil (like bike break cable) to transfer the force via a segment without causing it to curve. For example, FIG. 45B shows a proximal segment SI, wherein, an extension spring 812 is used (like a bike cable - transmits brake force without undergoing any compression). Hence, this segment SI does not experience any compression force when the pull-wire 802 is pulled, thereby, resulting in no mechanical advantage (MA = N/A or Not Applicable).

[0159] FIG. 46A, 46B, 46C, 46D, and 46E show exemplary configurations with various MA to rotate and or curve specific segments. As POSA will know, the bike cable feature 812 (MA = N/A), can be applied in the spiral/rotation segment too. Fig. 46A shows a helical configuration in segment S2, to enable rotation in one direction, upon pulling the pull-wire 802. Relaxing the pulled pull-wire 802 will result in the catheter shaft S2 rotating back in the reverse direction as shown in FIG. 46B.

[0160] Fig. 46C shows an exemplary embodiment having three segments SI, S2, S3, wherein, segments S2 is configured to rotate in one direction using a single pull-wire, while segment S3 is configured to rotate in both directions using two pull-wires, one for each direction, as shown in FIG. 46D and FIG. 46E. In other examples of embodiments, multiple segments and multiple pull-wire combinations may be used.

[0161] FIG. 47A shows an exemplary embodiment with rings/hoops 830 outside of the steerable section of the catheter shaft.

[0162] FIG. 47B show exemplary configurations with MA =2 in the steerable segment and a bike brake cable configuration 812 in the proximal, non-steerable segment. Furthermore, in this exemplary configuration, the pull-wire is connected at the two ends of the steerable segment. [0163] FIG. 48A and 48B show an example of an alternate embodiment of concept introduced in FIG. 47B, using pull wires that are outside of the catheter shaft.

[0164] FIG. 48C show an alternate exemplary embodiment of concept wherein, a hydraulic piston is used. If a suction is applied, the piston will shorten, causing the shaft to curve, as shown in FIG. 48D. Other means to actuate the piston can be fluidic, pneumatic, nitinol motor, electromagnetic, etc.

[0165] FIG. 48E shows alternative embodiment of FIG. 48C, where the piston is pressurized/inflated, to curve in the opposite direction. [0166] FIG. 48F shows an alternate embodiment balloon 843 is used to deflect the catheter. One advantage of using a balloon 843 is that it can add support to the catheter against the tissue/vessel.

[0167] Aortic Valve Devices

[0168] FIG. 49A shows an exemplary schematic of an aortic prosthetic valve with a high and wide frame that is correctly positioned, without blocking coronary artery ostia. Note, the valves are placed high (supra-annular). FIG. 49B shows a short height and narrow frame aortic prosthetic valve that is not aligned well causing obstruction (see arrow) of the coronary artery ostia, while FIG. 49C shows a short height frame with correct placement. Note, the valves are intra-annular. FIG. 49D shows incorrect placement of a high prosthetic valve, causing coronary ostia obstruction (see arrow). Note, the valve are supra-annular. FIG. 49E shows incorrect placement, where the device is too below the annulus, resulting in perivalvular leaks (see circle). FIG. 49F shows yet another example of incorrect placement, causing both coronary artery ostia obstruction (see arrow) and perivalvular leaks (see circle).

[0169] An advantage of this disclosure may be to securely place the prosthetic valve below the coronary ostia.

[0170] An advantage of this disclosure may be to atraumatically attach the prosthetic valve to aortic leaflets and/or aortic wall. This, without excessive expanding radial forces against the aortic wall, or cause distortion of the aortic structure by having a very stiff and very large prosthetic valve frame, in an attempt to mitigate leaks or migration.

[0171] An advantage of this disclosure may be that the prosthetic valve is primarily secured to the native leaflets and gently to the aortic base/annulus, allowing the prosthetic valve to be less rigid, more compliant, and better retain the natural elasticity of aortic wall compliance/motion/movement. This is critical feature, particularly in pediatric and younger patients.

[0172] An advantage of this disclosure may be that the prosthetic valve frame has replaceable or removable leaflets, to address any calcification or other loss of functionality of the leaflets during procedure, post procedure - acute and/or chronic (>1 day, >30 days, and/or >100 years). [0173] An advantage of this disclosure may be that the arms securing to the leaflets are actuatable (independently or simultaneously), with or without disturbing the body of the prosthetic valve.

[0174] An advantage of this disclosure may be that prosthetic valve leaflets can be placed at the level of native leaflets. [0175] An advantage of this disclosure may be that the prosthetic valve leaflets are secured to the frame similar to how the native leaflets are secure to the aortic wall/annulus, for improved hemodynamics akin to healthy native leaflets.

[0176] An advantage of this disclosure may be that the prosthetic valve can be of a very low height, secured by the atraumatic arms.

[0177] An advantage of this disclosure may be that the prosthetic valve leaflets can be placed below the annulus.

[0178] An advantage of this disclosure may be to superior protection against paravalvular leak by securely sealing the prosthetic valve body using arms and native leaflets, with or without a skirt.

[0179] An advantage of this disclosure may be to tarp, umbrella like flexible leaflets that has lower profile and more efficient or simpler in design.

[0180] An advantage of this disclosure may be that the tarp like leaflets can be accommodated or configured in both surgical (rigid) casing and flexible stent like casing configured to be delivered via catheters or minimally invasive procedures.

[0181] An advantage of this disclosure may be that the tarp like leaflet devices can be configured to be used with native leaflets to prevent regurgitation.

[0182] An advantage of this disclosure may be to having a spacer coupled with native or prosthetic leaflets to mitigate regurgitation.

[0183] An advantage of this disclosure may be to option of embolic protection, blood flow and or pressure management during advanced aortic valve procedures such as: resection of diseased native leaflets, resection or removal of calcified prosthetic leaflets or prosthetic valves.

[0184] An advantage of this disclosure may be to the ability to create a blood free zone (for example by blocking/diverting blood and using saline flush) at the site of the procedure to enable optical visualization for improved procedural outcomes, akin to, or more superior to invasive surgical techniques.

[0185] An advantage of this disclosure may be to the ability to configure/incorporate the blood management system/method with temporary valves, filters, heart pumps, sensors, actuators, drug delivery anti-calcification, anti-plaque, plaque/calcified lesion disruption, leaflet cutting/dissection/removal, electrical, thermal, magnetic, energy based, and or mechanical tools, to treat vascular/cardiovascular diseases. Additionally, enable commonly used tools that are normally reserved for invasive surgical procedures to be able to used in minimally invasive or catheter based procedure. [0186] An advantage of this disclosure may be to integrate heart pump within the blood management system during and post procedure.

[0187] An advantage of this disclosure of disclosure is a blood management device and method that allows the heart to be perfused by maintaining blood flow to the coronary arteries during the procedure.

[0188] An advantage of this disclosure may be to incorporation of dedicated tubes or blood flow paths to the coronary arteries during and or post procedure, as a temporary device or permanent implant, with or without implantation of a prosthetic valve.

[0189] An advantage of this disclosure may be to retrievable prosthetic valves that are either modular, detachable (cassette like) or integrated.

[0190] FIG. 50A to FIG. 50D show exemplary prosthetic aortic valve 1040 embodiments of disclosure comprising of a frame 1042 with actuatable arms 1020, 1024 and skirt 1062.

[0191] FIG. 51D to FIG. 51G show an exemplary method of implanting the prosthetic valve. FIG. 51D shows schematic of an aortic valve with a guidewire 1005. FIG. 51E shows the prosthetic valve body in a narrow-constrained condition, while the arms 1020 extend allowing for a leaflet insertion space. FIG. 51F shows the prosthetic valve over the native leaflets LF. Finally, the body of the prosthetic valve is expanded (self-expanding or balloon expanded), to securely and atraumatically engage with the native leaflets, as shown in FIG. 51G.

[0192] FIG. 52A-F shows an exemplary embodiment and method of disclosure, wherein, the arms 1020, 1024 are actuated independently to securely and atraumatically capture the native aortic leaflets. The arms 1020, 1024 are preferably self-biased to close on to the body 1040; and are connected via feature 1018 to the body 1042. The feature 1018 can be any means of attachment such as weld, spring, hinge, suture, weld, glue, screw, flexible joint, bendable joint, etc. FIG. 52A shows an exemplary schematic of an aortic prosthetic device 1040 with leaflet grasping arms 1020 and 1024. Note, only two leaflets LF and two arms are shown for simplicity. Typically for aortic valve has 3 leaflets, hence, the prosthetic device 1040 may have at least one arm to grasp at least one leaflet. Preferably, the prosthetic device will have at least 3 arms for the 3 leaflets. The arms can be attached to the device 1040 via a feature 1018. The feature 1018 can be suture, a hinge, weld, glue, screw, and/or a rivet. The arm can be elastic, superelastic, shape memory, rigid and/or flexible material that can configured to be biased towards the prosthetic device. It can be made of nitinol, metal, plastic, ceramic or their combination. The delivery catheter 1012 comprises of a lever arm 1016, used to provide the required mechanical advantage to actuate the arms 1020, 1024 using sutures 1032, 1034 so as to create a separation to allow a leaflet to be inserted, as shown in FIG. 52B and 52C. The lever arm 1016 can be swinging, bending, expanding, hinged arms, motor, and or any means known to POSA, that can actuate the arm, preferably with some mechanical advantage to actuate or apply biasing force/motion to open the arms 1020, 1024, while allowing the lever arm feature to be retracted/folded inside the delivery catheter. Note: there can be additional mechanisms to actuate the lever arm itself, so as to transform/translate the lever arm from low profile (position 1 : contained within the catheter profile) to position 2 (expanded/extended position) to better exert the forces needed to actuate the arms 1020, 1024. The lever arms 1016 themselves can be configured to be individually or simultaneously actuatable. Each of the arms can be configured to be actuated individually, sequentially, or independently as shown in FIG. 52B. Alternatively, they may be actuated simultaneously, as shown in FIG. 52C. The device 1040 is then advanced over the leaflets as shown in FIG. 52D and the leaflets are captured by dropping the arms over the leaflets, as in FIG. 52E. The arms or the device can have barbs or other frictional elements to securely and atraumatically grasp the leaflets. The device can be repositioned, redeployed, or removed, by re-actuating the arms 1020, 1024, repeatedly, if necessary. The device can then be separated from the delivery system. In some alternate embodiments, the device can be reversibly separated from the delivery catheter by having retrieval features on the device 1040.

[0193] FIG. 53A-F shows an alternate embodiment similar to FIG. 52A-F, with actuatable lever arms 1046, with a variation where is actuating suture is below (distal) to the lever arm position. FIG. 53F shows an example of lever arm 1046 configuration, where the lever drops/ swivels to provide the necessary lever arm to exert biasing forces to the arms 1020, 1024.

[0194] FIG. 54A-B shows an alternate embodiment of the disclosure shown in FIG. 52A-F, wherein, the native aortic leaflets can be regrasped, repositioned, redeployed and evaluated/assessed multiple times in the fully expanded state of the prosthetic valve body. Furthermore, the arms can have a large range of motion for superior placement, bailout, removal, and/or retrieval of the device, as shown in FIG. 54A and FIG. 54B. FIG. 54A shows arm manipulations in fully expanded state of the aortic prosthetic device 1040 with leaflet grasping arms 1020 and 1024. Note, only two leaflets LF and two arms are shown for simplicity. Typically for aortic, there will be 3 arms and 3 leaflets. However, in some embodiments, more than 1, 2, 3, 4, ..., 99, and/or 100 arms may be used. In some embodiments, the arms can be actuated up to an inverted position, as shown in FIG. 54A. FIG. 54C is an exemplary embodiment of the lever arm, that needs to be raised/actuated/s wived (outside of the catheter profile), to provide the necessary mechanical advantage. Any means can be used to raise/ rotate it, such as a suture, screw mechanism, hydraulic, electrical, chemical, pneumatic etc. [0195] The arms 1020, 1021, 1024 can be multiple components as shown in FIG. 55A. FIG. 55B shows arms 1020, 1021 that are two components fastened via feature 1018 and configured to be biased towards each other. For example, in one configuration, the arm 1020 can be made of shape-set, superelastic material such as nitinol and the dotted line of the arm 1020 shows the unbiased shape-set position. The arms can be attached at their base or anywhere between the arm and the device. FIG. 55C shows an example, where both 1020 and 1021 are made of continuous material/structure.

[0196] FIG. 56A-C shows an alternate embodiment of device 1040, wherein, it is configured to have a pair of arms (1021,1020 and 1024, 1027) to grasp form both outer 1020, 1024 and inner 1021, 1027 side of the leaflet. These arms can be mechanically (via hinges, gears, etc) biased or self-biased elastically, example using nitinol. See co-owned prior arts for further description. In this exemplary embodiment, the arms are made of nitinol. Suture 1032 is used to actuate outer arm 1020 and suture 1052 is used to actuate inner arm 1021, while suture 1034 is used to actuate outer arm 1024 and suture 1056 is used to actuate inner arm 1027.

[0197] FIG. 57A and 57B show exemplary embodiment of lever arm shown in FIG. 53F. [0198] FIG. 58A and 58B show exemplary embodiment of lever arm shown in FIG. 54C.

[0199] FIG. 59A shows an exemplary embodiment of disclosure, where the actuatable arms and the native tissue interfacing frame have atraumatic frictional elements 1070, designed to engage with the native leaflets and/or the aortic wall.

[0200] FIG. 59B shows an exemplary embodiment of disclosure that has a modular replaceable insert 1045 comprising of leaflets, within the frame that engages with the native leaflets and aortic wall. The insert can be reversibly attached using common techniques, such as, press-fit, twist fit, screw fit, chemical, electrical, and or magnetic fit.

[0201] FIG. 59C shows an exemplary embodiment of FIG. 59B, additionally comprising of an atraumatic annular grasping/engaging/frictional feature 1070. At this location, and/or external to the prosthetic frame, a skirt 1062 comprising of sponge, gel, fabric, film, mesh, braid, balloon, and/or fibers may be used to augment prevention of perivalvular leaks.

[0202] FIG. 59D shows device shown in FIG. 50A in an aortic valve schematic.

[0203] FIG. 59F shows an exemplary ultra-low profile embodiment of frame 1042, configured to comprise a tarp or flexible film leaflet 1075. The tarp 1075 maybe attached to the frame 1042 using a feature 1072 comprising of any common fastening/welding/bonding/screwing/securing means. FIG. 59F shows the prosthetic aortic valve 1040, in diastole phase of the heart wherein, the tarp 1075 stops the blood flow back into the left ventricle (see arrow). [0204] FIG. 59G show the exemplary valve 1040 embodiment shown in FIG. 59F, during systole, wherein, the tarp 1075 flexes open due to the blood flowing into the aorta from the left ventricle (see arrow).

[0205] FIG. 59H and 591 show yet another exemplary embodiment ultra-low profile frame 1042 with leaflets. In one embodiment, the leaflets can be configured to be attached only to the base of the frame 1042. In another alternate embodiment, the leaflets can be attached to a post or extended height feature added to the frame 1042 too.

[0206] FIG. 59J shows device shown in FIG. 59H with a post in an aortic valve schematic.

[0207] FIG 59K to FIG. 590 show exemplary embodiment variations of FIG 59A to FIG. 59D, wherein, the prosthetic leaflets/inserts are generally attached/extending below the body of frame 1042.

[0208] FIG. 60A reproduces JenaValve FIG. 22D of PCT/US2023/080979, the entire application including US10575947B2 incorporated here in its entirety by reference. FIG. 60B shows the schematic of the positioning element 1064a, body 1042a, and skirt 1062a. Note: the suffix ‘a’ to the reference number is attached to equivalent features. FIG. 60C shows just the positioning element 1064a configuration of JenaValve in relation to the frame 1042a and skirt 1062a. FIG. 60D shows and alternate embodiment of disclosure, wherein, the positioning element 1064 encompasses the skirt 1062. FIG. 60E shows an alternate embodiment of disclosure, wherein, the positioning element 1064 extends beyond the skirt 1062.

[0209] FIG. 61 A shows the JenaValve schematic of the positioning element 1064a, body 1042a, and skirt 1062a. FIG. 61B to FIG. 61D show exemplary embodiments of disclosure that are relatively shorter or more compact than the JenaValve (FIG. 61A). FIG. 61B shows an exemplary embodiment of disclosure, wherein, the actuatable arm 1020, 1024 are much wider, and configured to provide both anchoring with leaflets and sealing against the leaflets (in between) and the skirt 1062. FIG. 61C shows and alternate embodiment of FIG. 61B and FIG. 61C, wherein, the arm 1020 encompasses extends beyond the skirt 1062.

[0210] FIG. 62A shows a prosthetic device 1040 with actuatable arms with a skirt 1062 to prevent perivalvular leaks. The skirt can be hollow, balloon, stent with a cover, or any structure with a cover, an expandable and compressible structure, perforated structure, fabric, braid, film, coating, cushion, sponge, sponge-like structure, or any structure that can prevent blood leaks. FIG. 62B, 62C, 62D show the example of prosthetic valve with various embodiments of position markers 1064, to aid in positioning and grasping by actuatable arms 1020, 1024, 1028, 1021. [0211] In an alternate exemplary embodiment, the positional markers 1064 can also be simultaneously or independently actuatable or repositioned, with or without disturbing, manipulation, moving, and or actuating the prosthetic valve body 1042.

[0212] FIG. 62E and 62F show exemplary disclosures, wherein, the valve implant has one or more valve retrievable features 1300, 1310, 1320 to aid removal of the valve 1040 at a later date, post implantation (post complete detachment from the delivery system). The retrievable features 1300, 1310, 1320 can be suture loop, a hook, magnet, wires, threads, or any commonly known features that aid retrieval of device post implantation (see co-owned patents for additional details). These retrievable features can optionally have features that aid in detection, for example radio-opaque, echogenic, magnetic, florescent, etc. The features can be of polymer, metal, ceramic, nitinol, etc. The retrievable features can also be actuatable, deployable, remotely triggerable, in order to have low profile when not needed and easily graspable or detectable when needed (for easy retrieval). In some embodiments, the retrievable features are used stabilize the frame.

[0213] FIG. 62G shows an exemplary disclosure, wherein, the prosthetic valve 1040 comprises of valve housing 1042 and replaceable valve 1045. The valve housing can typically comprise of primary fixation features that are more of less fixed to the tissue post implantation, for example: the frame 1042, arms 1020, 1022, 1024, 1026, skirt 1062 etc. The replaceable valve comprises 1045 of the prosthetic leaflets with replaceable frame 1045. Additionally, the replaceable frame may comprise of retrievable features. In some embodiments, the retrievable features are on both valve housing 1042 and replaceable valve 1045. For example, the studs, hooks, or slots in the valve housing 1042 may be used to stabilize it, while the retrievable feature on the replaceable valve 1045 can be used to detach, remove, and replace it. In one alternate embodiment, the replaceable valve 1045 has tearable valve leaflets and secondary frame, to easily remove failed prosthetic valve leaflets. One advantage of this disclosure may be that it allows for easy repair, in event of any failure of the valve in a future date, post implantation (or during implantation). This, to mitigate the need for cutting of failed prosthetic valve or removal of the entire failed prosthetic valve, which will require cutting of surround tissue, including the native leaflets.

[0214] In aortic stenosis, the common cause is heavy calcification in the native leaflets. This leaves very little space for blood flow and/or restricts the motion of the leaflets. Likewise, prosthetic tissue valves fail in 7 to 15 years, typically due to leaflet calcification. Hence, it is beneficial to either remove the failed prosthetic valve completely or cut the prosthetic leaflets (entirely or partially, prior to replacing it with a new prosthetic valve. However, once the calcified leaflets are cut, the blood flow and pressure will be compromised until the new prosthetic valve is deployed/implanted. A temporary valve can be placed either downstream or upstream of the coronary sinus to mitigate this issue. If the temporary valve is placed upstream to the aortic valve (or coronary sinus), then the blood flow to the coronary arteries are not compromised. If the temporary valve is placed downstream to the coronary sinus, then, there needs to be a way to supply blood flow to the coronary arteries. In either case, it is critical to ensure that the blood flow to the coronary arteries and downstream organs is devoid of any debris or thrombus or emboli that can form during resection of the diseased native valve or failed prosthetic valve. This can be achieved by placing a downstream filter immediately after the valve, for example at the ascending aorta and before the coronary sinus. Alternatively, the filter can be placed downstream of the coronary sinus, in which case, debris free blood to the coronaries can be provided using tubes 1164, as shown in FIG. 63A. As it is obvious to POSA, the seal of the blood flow to coronary may be achieved using commonly known means, including a snug fit tube, tapered tube, inflatable balloon, spongy cuff, a stent, O-ring, etc. The sealing features can be part of one or more tubes 1164. FIG. 63B shows an exemplary balloon cuff 1155 that seals both tubes 1164 simultaneously.

[0215] Furthermore, as POSA can understand, the exemplary configuration of embodiment of FIG. 63A, the positions of temporary valve 1140 and filter 1150 can be interchangeable, that is, the filter 1150 may be placed immediately upstream to the temporary valve 1140, as shown in FIG. 63B. Alternatively, the functions of filter and temporary valve can be combined into a single embodiment. In an alternate embodiment of the temporary valve, its function can be changed from being a one-way valve (flow in single direction) to a two-way valve (flow in both directions). This can be achieved mechanically, electrically, electronically, chemically, magnetically, using software, fluidic trigger, etc. The same valve can be switched/transformed/changed to always remain in open position (allowing flow in both directions) or perform normally as a check valve (open in forward direction flow and closed in reverse direction flow. Alternatively, the temporary valve may have any configuration obvious to POSA that allows for selectable flow control.

[0216] Temporary valves can be placed FIG. 64A-C show various configurations of temporary valves that are placed upstream of coronary sinus, either immediately below the native valve or in between the coronary artery ostia, CA, and native valve. This ensures that flow to coronary arteries is not compromised. Similar to FIG. 63A and 63B, filters may be used to mitigate embolic debris during the procedure (not shown here for simplicity).

[0217] FIG. 64A shows a upstream temporary valve 1130 that is stabilized using a stent and or filter 1150 and an interfacing member 1160. Note, the stent can be hollow, incorporate (or comprise of) filter, ports, a and or secondary temporary valve (in addition to 1130). The interfacing member 1160 can be stiff, flexible, elastic, plastic, superelastic, straight, curved, single wire, multiple wires, braid, coil, laser cut, metal, stretchable, changeable length, polymer, etc. and can be detachably attached to both stent 1150 and temporary valve 1130, 1140. FIG. 64B shows an alternate embodiment, wherein, the temporary valve 1130, 1140 is stabilized / supported or held in place using a catheter shaft 1170, with or without comprising interfacing member 1160. The catheter is coming from retrograde direction. FIG. 64C shows an alternate embodiment, wherein, the catheter shaft 1170 is coming from the ventricles (antegrade). In an alternate embodiment, the temporary valve may have a combination of the embodiments shown in FIG. 60A-64C.

[0218] One advantage of this disclosure may be that the temporary valve 1140, 1130 can be configured to continue to function as a permanent valve. In an alternate embodiment of disclosure, the temporary valve 1130, 1140, filter 1150, and or interfacing members 1160 can comprise of sensors, motors, controllable length, drug delivery system, wireless, rfid, actuators, visualization systems, energy delivery or monitoring system, patient monitoring devices/sy stems, and or heart pump (for example: left ventricular assist devices), including any other feature as understood by POSA. One advantage of this disclosure may be that any damage on removal of the diseased native valve or failed prosthetic valve can be mitigated by placing the prosthetic valve downstream or upstream to the native valve, where the tissue is relatively free of damage or has more suitable anatomy. As POSA may understand, the temporary filter and temporary valve position may be interchangeable or incorporation in the same structure, and is used only for short term, and may be removed at the end of the procedure or at a later date. [0219] FIG. 65A shows exemplary embodiments of the filter 1150 and temporary valve 1130. The filter comprises of a mesh 1148 and a self-sealing or sealable port 1145 to advance various catheters. The mesh can be any known filters, that are commonly used in medical device industry. The port 1145, can be any commonly known means in the catheter industry that allows passage of catheters, such as a self-sealing film, barrier, and or a valve. The temporary valve 1130 can be a tri -leaflet design, mono-leaflet, bi-leaflet, or more than 1 leaflet valve, a check valve, a duck-bill valve, a disc valve, a cone valve, a low-profile valve, etc. Alternatively, it too can have port similar to port 1145 to allow for passage of a catheter, while maintaining the pressure differential across the port/valve. Alternatively, the filter 1148, 1150 can be inside the catheter, when the blood is configured to flow through the catheter.

[0220] FIG. 65B shows an exemplary embodiment of the temporary valve 1130 with stabilizing catheter 1170 and interfacing member 1160. [0221] FIG. 65C shows an exemplary configuration of the temporary valve 1130, 1140, and or filter 1150, comprising of coronary artery feeding tubes 1164 and a sealable or self-sealing catheter port 1145 and a one-way valve 1142. Seal between the tubes 1164 and coronary sinus can be achieved using any of the following exemplary means/methods: snug fit tubing, longer length tubing, conical tubing, O-ring based concept, expandable, inflatable, fillable, compressible cuff, balloon, suture, clip etc., known to the POSA.

[0222] FIG. 65D shows the seal at the coronary sinus is created using donut like balloons, wherein, the tubes are passing through the cross-section of the balloon. Also, the size and the form of the ports and valve configuration can be interchangeable.

[0223] FIG. 66A shows a variation of the exemplary disclosure, wherein, a previously deployed prosthetic valve 1100 is removed and replaced with a new prosthetic valve 1040. FIG. 66A shows placement of a temporary valve 1140 (note filter 1150 and tubes 1164 are not shown for simplicity) and advancement and placement of a cutter device 1110 towards the existing prosthetic valve 1100. In FIG. 66B, the existing prosthetic valve is excised using any means commonly known to POSA, such a cutting, coring, punching, shaving, burring, grinding, RF energy cutter, US, ablation, ultrasonic cutter, ultrasonic homogenizer/ pulverizer, wire cutting, liquid jet, fluid jet, laser, chemical ablation, etc.

[0224] FIG. 66C shows the temporary valve in place and the existing prosthetic valve excised and removed. In this exemplary embodiment, a significant portion of the native valve leaflets are cut too. Alternatively, the leaflets may be cut partially, to allow for increased grasping via arms 1020 or body 1042, and or skirt 1062. FIG. 66D shows placement of a new prosthetic valve 1040, secured with arms 1020, 1021, 1022, 1024, 1026 , 1027 that grasp the leaflets (or anatomy beyond the leaflets) from both sides. However, as evident from the disclosure, there can be various ways to attach, including using a clip, suture, barbs, cork screw, pins, adhesive, fusion achieved via chemical, electrical, mechanical, ultrasound, etc. Fig. 66E shows an alternate method of grasping and securing the valve. Any of the valves in disclosure (temporary or permanent) may comprise of a one way valve, a port, a tube. They can be of low profile designs, including and not limited to the designs derived from mechanical valves, tissue valves, industrial valves. The valves can be self-expanding, expandable, compressible, bendable, twistable, shrinkable, etc to enhance compliance with catheter-based and or minimally invasive delivery. [0225] FIG. 67A-H shows a method of replacing failed aortic valve with new aortic valve with or without visualization. FIG. 67A shows a guidewire 1005 through the failed valve 1100.

[0226] FIG. 67B shows catheter 1012 inserted over the guidewire. Temporary valve 1140 and optionally filter 1150 can be placed inline, Cuffs 1200 are deployed. Note, the Cuff 1200 can be balloon, hemispheric, concave, cup shaped, bowl shaped, expandable umbrella like structure, disc, stent, or any feature used or configured to restrict or divert blood flow. Further, the cuff may have additional ports to allow multiple catheters, external to catheter 1012. Optional and exemplary conduits 1164 may be used to maintain blood supply to the coronary arteries. In addition, the Cuffs 1200 and conduits 1164 may be alternatively placed/deployed using a separate, independent, and dedicated catheter, prior to or after insertion of the catheter 1012 or along with it (working in tandem). Alternately, in place of the cuff 1200, a temporary valve 1140 and filter 1150 can be deployed outside of the catheter. Any of the temporary valves and filters described in disclosure can be incorporated inside the catheter 1012 with ports or holes 1210, 1220 to allow for blood flow and cuff or balloons seal along the blood vessel. Alternatively, a separate removable catheter (inside or outside of catheter 1012) with temporary valves, filters, cuffs, may be used in parallel to direct and filter blood flow and provide a safe working zone, during removal of the failed valve 1100.

[0227] FIG. 67C shows an disclosure wherein, an additional cuff 1200 is placed and ports 1230, 1240 are used to flush the working zone around the failed valve (native or prosthetic) with clear, translucent, or transparent liquid such as heparinized saline, to aid visualization using fixed or steerable cameras 1250 (obvious to POSA). The safe visualization method is not limited to optical, any other visualization technique commonly known in the medical device or engineering industry maybe used, for example, ICE catheter echography. POSA is aware that saline visualization if preferred, however, is an optional step that is redundant with normal imaging techniques such as echography, fluoroscopy, IVUS, ICE, infrared, OCT, etc. Optionally, in an alternate embodiment, the port hole 1210 1220, can comprise of an LVAD motor/pump to offload the pressure across the aortic valve.

[0228] FIG. 67D shows an exemplary cutting tool used to resect the failed valve 1100. As POSA may appreciate, any known technique can be used to capture and remove the failed valve using transcatheter technique. The failed valve 1100 may be removed using a multiple catheters if needed from both antegrade and or retrograde path. Additionally, the failed device may be removed as a whole or in fragments. In one exemplary embodiment of disclosure, only the leaflets of the prosthetic valve 1100 are cut and removed. In which case, the new prosthetic valve 1040 will be deployed inside the frame of the failed prosthetic valve 1100. Note: In an alternate embodiment, POSA will appreciate that this procedure or method can be used to completely or partially cut and remove native valves too.

[0229] FIG. 67E shows the stage post removal of the failed device 1100. Note: One advantage of this disclosure may be that once the temporary valve is in place, the patient can be recovered (pre or post removal of the failed valve 1100) and this procedure can be continued at a later time or date.

[0230] FIG. 67F shows placement of the new prosthetic valve 1040, using actuatable arms to enhanced fixation and sealing of the valve 1040. More than one arm (1020, 1021, 1024, 1027, or 1026) may be used. Additionally, the arms can be used in pairs (for example, 1020 and 1021) and more than one pair of arms (for example, 1024 and 1027, 1020 and 1021) may be used. However, as POSA will appreciate, this method can be used to deliver any traditional and or commercial valve (without actively actuatable arms). Along with saline flush, an optical camera can be used for visualization. The camera system can be integrated (embedded or as an retractable/ steerable extension of the catheter. Alternatively, a separate camera system may be inserted inside or outside of the catheter

[0231] FIG. 67G shows an exemplary embodiment of the disclosure, wherein, the flow modifying cuffs 1200 are removed, disabled, or de-actuated to allow free flow of blood. This, to allow for realtime or traditional assessment of the new prosthetic valve. In an alternate method/embodiment, the catheter can be retracted from the prosthetic valve leaflets during assessment. In an alternate embodiment, larger segment of the catheter can be retracted, and replaced with a significantly smaller size catheter during assessment and subsequent repositioning or manipulation of the arms 1020, 1022, 1024, 1026, of the prosthetic valve 1040, to improve quality of assessment. A POSA is aware, debris filter can always be used during this entire procedure. Furthermore, the debris filter may be part of this system or an external commercial system or both.

[0232] In this step, the new prosthetic valve 1040 may be optionally repositioned, redeployed, or completely removed from the catheter (and replaced with a different (size or shape) valve if needed. The valve 1040 can be repositioned, redeployed, completely removed and replaced with a different valve, multiple times. Note: The flow modifying cuffs 1200, temporary valve 1140, filter 1150, ports 1210, 1220, 1230, 1240 can be deactivated/reactivated, disabled/enabled or opened/closed, inflated/deflated, turned on / turned off, deactuated/actuated repeatedly/multiple times if needed, to allow for assessment, manipulation, or removal/replacement of any of the valves 1040, 1100, during the procedure.

[0233] FIG. 67H shows the new prosthetic valve 1040, after removal of the delivery catheter 1012. Any other procedure supporting features, such as filters, temporary valves, sensors, or any embodiments described in disclosure or known to posa, used to monitor, help in speedy recovery, fine tune the implant/valve or assess the healing maybe removed during the procedure or at a later time or date. [0234] FIG. 68A-D shows a method of aortic valve deployment without cutting native leaflets. [0235] FIG. 68A shows guidewire placed through the exemplary aortic valve schematic. While this exemplary method is shown in traditional retrograde approach to the aortic valve (from femoral artery access), this procedure can be alternatively performed from the antegrade approach (for example, from femoral vein access, via right atrium (trans-septal), left atrium, left ventricle to the aortic valve).

[0236] FIG. 68B shows insertion of the catheter 1012 over the guidewire 1005 (not shown for simplicity) and deployment of the filter 1150.

[0237] FIG. 68C shows placement of the prosthetic valve 1040. One advantage of this disclosure may be that actuatable arms can be used as position markers and or for attaching to the leaflets, and or for sealing the perivalvular leaks. Additionally, dedicated position markers 1062 can be used along with the actuatable arms 1020, 1022, 1024, 1026. One advantage of this disclosure may be that the arms can be independently or simultaneously actuated. One advantage of this disclosure may be that the delivery catheter comprises of a deployable filter 1142. One advantage of this disclosure may be that the filter can remain in place for extended period of time (preferably between 1 to 30 day or 1 to 180 days) post implantation and removed at a later time or date, to reduce or eliminate the need for blood thinners. One advantage of this disclosure may be that traditional valve (without actuatable arms) can also be used. One advantage of this disclosure may be that the valve can be assessed or repositioned both in compressed and fully expanded state. One advantage of this disclosure may be that the prosthetic valve has retrievable features such as sutures, wire loops, hooks, (see co-owned patent for additional description), for ease of retrieval. One advantage of this disclosure may be that the filter 1150 and optionally be paired with a one-way, two-way, and or configurabl e/ switchabl e/ sei ectabl e valve .

[0238] FIG. 68D shows the implanted prosthetic valve 1040. One advantage of this disclosure may be the prosthetic valvel040 can comprise of valve housing 1042 and replaceable valve 1045.

[0239] FIG. 69A-69D shows a method of traditional deployment without cutting native leaflets and with visualization and blood flow management to the coronary arteries.

[0240] FIG. 69A is same as FIG. 68A.

[0241] FIG. 69B comprises of FIG. 68B and additionally comprises of ports 1210, 1220 with a temporary one-way valve 1140 embedded inside the catheter, cuffs 1200, and ports 1230, 1240, used to flush with clear liquid such as heparinized saline. A camera 1250 can then be used to optically visualize the valve structures. Optionally, in an alternate embodiment, the port hole 1210 1220, can comprise of an LVAD motor/pump to off-load the pressure across the aortic valve.

[0242] FIG. 69C is similar to FIG. 68C with the addition of the ability to visually see the internal structures between the two cuffs 1200.

[0243] FIG. 69D shows the end result, similar to FIG. 68D.

[0244] FIG. 70A-70F shows an exemplary method of aortic valve deployment with cutting of native leaflets.

[0245] FIG. 70A is same as FIG. 68A.

[0246] FIG. 70B comprises of FIG. 68B and additionally comprises of temporary valve 1140, tubes 1162 to supply blood to coronary arteries. A filter 1150 may be optionally used.

[0247] FIG. 70C is similar to FIG. 68B, and additionally, the native leaflets are cut using blades 1110 for example and removed. Alternatively, laser, rf, ultrasound, chemical, or any combination of energy sources known to POSA may be used.

[0248] FIG. 70D shows the valve with cut native leaflets. The leaflets can be completely or partially cut.

[0249] FIG. 70E shows placement of the prosthetic valve 1040, by manipulating arms 1020, 1021, 1024, 1027. Similar to FIG. 68C, suture 1032 is used to actuate arm 1020 and suture 1034 is used to actuate arm 1024, suture 1052 is used to actuate arm 1021, and suture 1056 is used to actuate arm 1027. Once the physician is ready to test the efficacy of the valve, he can reversibly switch the temporary valve 1140 from being a one-way valve to a two-way valve, freely allowing the blood to flow in both directions.

[0250] FIG. 70F shows fully implanted prosthetic valve 1040, with an alternate arms configuration. One advantage of this disclosure may be that more than 2 arms can be placed anywhere along the height of the valve.

[0251] FIG. 71 shows an alternate method of prosthetic aortic valve deployment with cutting of native leaflets with saline flush for visualization.

[0252] FIG. 71A is same as FIG. 69A or FIG. 68A.

[0253] FIG. 71B is similar to FIG. 69B and comprises of ports 1210, 1220 with a temporary one-way valve through the catheter, cuffs 1200, and ports 1230, 1240, used to flush clear liquid such as heparinized saline. A camera can then be used to optically visualize the valve structures and or other structures between the two cuffs 1200. Optionally, in an alternate embodiment, the port hole 1210 1220, can comprise of an LVAD motor/pump to off-load the pressure across the aortic valve. [0254] FIG. 71C shows the native leaflets are cut using blades 1110 for example and removed. This procedure can be performed under optical visualization.

[0255] FIG. 71D shows the valve with cut native leaflets. The native leaflets can be completely or partially cut and removed.

[0256] FIG. 71E shows placement of the prosthetic valve 1040, by manipulating arms 1020, 1021, 1024, 1027. Similar to FIG. 20C, suture 1032 is used to actuate arm 1020 and suture 1034 is used to actuate arm 1024, suture 1052 is used to actuate arm 1021, and suture 1056 is used to actuate arm 1027. In an exemplary embodiment, once the physician is ready to test the efficacy of the valve, he can reversibly switch the temporary valve 1140 from being a one-way valve to a two-way valve, freely allowing the blood to flow in both directions.

[0257] FIG. 71F shows fully implanted prosthetic valve 1040, with an alternate arms configuration. One advantage of this disclosure may be that more than 2 arms can be placed anywhere along the height of the valve. Note: In case of a failed prosthetic valve 1100, this same procedure can be followed to cut and remove the failed valve 1100 or alternatively, cut and remove only the prosthetic leaflets of the failed valve 1100.

[0258] Fig 72A shows an exemplary stent body 1078 with a flexible tarp like feature 1075, which can cover the gap between the leaflets to mitigate regurgitation. The tarp can be flexible, rigid, stretchable, non-stretchable, hollow, balloon, stent with a cover, or any structure with a cover, an expandable and compressible structure, perforated structure, fabric, braid, film, mesh, fibrous, coated, cushion, sponge, sponge-like structure, or any structure that can mitigate valve regurgitation when placed over the gap between the leaflets. The tarp can be made of metal, plastic, biological origin, non-biological origin, ceramic, superelastic, shape memory, composite, fabric, braid, machined, 3d printed, or any combination known to POSA. The tarp can comprise of at least one structure, 2 structures or 3 or more structures. It can have single leaflet covering, double leaflet covering, or 3 or more leaflet covering. It can be of any shape, circular, pizza, triangular, trapezoid, square, oval, umbrella, and so on. It can be corrugated, folded, smooth, fan like bladed structure, Japanese foldable/ slidable fan like structure, with slits or without any slits. The tarp can have features, stiffening members, wires, sheets, along the rim and sides to configure and optimize the shape during diastole (to minimize regurgitation) and during systole (to maximize blood flow).

[0259] In an alternate embodiment, FIG. 72A shows a stent structure 1078 that engages with the wall/Orifice of the valve just below the coronary ostia or about the level of the leaflets and is configured to support the tarp 1075. In one exemplary embodiment, the tarp 1075 folds down to cover over the gap in between the leaflets during diastole (solid line in 1075 and LF) to mitigate the regurgitation. In systole, the native leaflets open (dotted lines) and the tarp 1075 (dotted lines) folds upward and away from the leaflets to allow blood flow. The folding of the tarp can be passive (moving along with the blood flow) or active (controlled remotely or using a logic, fluidics, or programed). In passive mode, the extent of folding or shape of the tarp can controlled by configuring the structure of tarp by adjusting flexibility /bending modulus at each zone/segment/slice/section of the tarp 1075.

[0260] FIG. 72B shows a variation of the exemplary embodiment shown in FIG. 72A, wherein, the tarp 1075 is supported via a low-profile connecting feature 1076. The feature 1076 can be a suture, wire, stent structure, tube, etc. Furthermore, the feature 1076 can be stiff, elastic, superelastic, flexible, bendable, telescoping, adjustable, smart controlled, etc. Furthermore, the low profile feature 1076 is supported with a feature 1077 that is configured to attach to the base of the aorta as shown. The feature 1077 can have barbs, clasps, crocodile teeth, or any grasping feature that is mechanically actuated (non- superelastic or steel based) or self-biased (shape memory, superelastic, nitinol based).

[0261] FIG. 72C shows a variation of the exemplary embodiment shown in FIG. 72A, wherein, the tarp 1075 is supported via a low-profile feature 1076, which in turn is supported with a stent structure 1078 above the coronary ostia or much above the tip of the leaflets.

[0262] FIG. 72D shows the exemplary alternate device as shown in FIG. 72B. Although, in this the tarp 1075 is shown as a single disc shape, it can be of any geometry, optimized for patient specific disease (regurgitation).

[0263] FIG. 73A and 73B show an exemplary embodiment of a spacer 1080 with an arm 1020 during diastole. The spacer 1080 is configured to fill the gap to mitigate regurgitation. Although the shape of the spacer is shown to be cylindrical (with circular cross-section), the shape and cross-section can be any geometric shape, including a star, triangular, flat, crescent, ellipsoidal, etc. Further, the spacer 1080 can be expandable, compressible, stretchable, inflatable, porous, solid, wire form, sponge, to name a few examples. Lastly, the spacer 1080 can be smart, and the shape may be changed remotely electronically or hydraulically, or mechanically or chemically but not limited to these examples. For example, in one exemplary embodiment, the spacer may be controlled to expand to mitigate regurgitation in diastole and shrink to maximize flow during systole.

[0264] FIG. 73C and 73D show the exemplary embodiment of FIG. 73A and FIG. 73B during systole, respectively. [0265] While the exemplary embodiments in FIG. 73A to FIG. 73D show a single spacer 1080 attached to a single leaflet, there can be more than one spacer device attached to a leaflet. Furthermore, more than one leaflets may be attached to 1 or more spacer devices.

[0266] FIG. 73E and FIG. 73F show the spacer 1080 attached to various stent 1078, 1077 configurations. The stent 1078 is at the level of the leaflet tip in FIG. 73E. The spacer 1080 is attached via feature 1076 to both stents 1078 above the leaflet and stent 1077 below the leaflet, as shown in FIG. 73F.

[0267] In an alternate embodiment, the spacer 1080 may be replaced with a prosthetic valve 1040, configured to mitigate regurgitation.

[0268] FIG. 74A and 74B show an exemplary embodiment of a lid 1090 with an arm 1020 during diastole. The lid/tarp/disc 1090 is configured to fill the gap to mitigate regurgitation. Although the shape of the lid 1090 is shown to be cylindrical (with circular cross-section), the shape and cross-section can be any geometric shape, including a star, triangular, flat, crescent, etc. Further, the lid can be expandable, compressible, stretchable, synthetic, 3d printed, molded, extruded, fabricated, layered with films, reinforced composite structure, inflatable, porous, solid, wire form, sponge, to name a few examples. Lastly, the spacer can be smart, and the shape may be changed remotely electronically or hydraulically, or mechanically or chemically but not limited to these examples.

[0269] FIG. 74C and 74D show the exemplary embodiment of Fig. 74A and 74B during systole, respectively.

[0270] While the exemplary embodiments in FIG. 74A to FIG. 74D show a single lid 1090 attached to a single leaflet, there can be more than one lid device attached to a leaflet. Furthermore, more than one leaflets may be attached to 1 or more lid 1090 features.

[0271] FIG. 74E and 74F show an exemplary embodiment of the tarp/film 1075 attached to arms 1020, 1022, attached to a leaflet in diastole (FIG. 74E) and systole (FIG. 74F), respectively.

[0272] As POSA may understand, the embodiments described in disclosure for Aortic Valve, can be applied to other heart valves (for example, mitral, tricuspid, pulmonary valves), venous valves, or any other valves or features in the human body/robots/humanoids.

[0273] FIG. 75A shows a commercial mechanical valve. One of the issues with it is exposed metal. Despite being covered by carbon coating to improve hemocompatibility, the valve is still thrombogenic and required blood thinners for life. Furthermore, it makes annoying clicking noise and needs to be surgically implanted. [0274] One of the exemplary embodiment of disclosure is to cover the exposed metal (including any and all of the long term implant embodiments described in this entire document) with dampening, shock absorbing, sound absorbing, and or endothelium promoting features, coatings, and or coverings. For example: film, fabric, braid, mesh, woven, fibrous paper etc made of commonly known tissue growth promoting materials such as eptfe, pet or polyester in the form of, etc.

[0275] One of the exemplary embodiment of disclosure is to replace the metal leaflets with polymeric or composite materials. The polymeric leaflet can be rigid, flexible, tarp like, silicone, rubber like, reinforced plastic, 3D printed, fabric, fiber/wire/nitinol reinforced fabric, and/or etc. These leaflets can optionally be coated or covered. Examples of composite materials can be fiber reinforced, nitinol reinforced base material such as fabric, metal, braid, ceramic, and/or plastic. [0276] One of the exemplary embodiment of disclosure is to decrease the travel of the leaflets to fully close, thereby, reducing the hammer effect and stress on the leaflets. For example, the height of implant can be configured such that the leaflet close within 45 degrees of travel, preferably about 20 degrees.

[0277] One of the exemplary embodiment of disclosure is to dampen the impact of leaflet closure forces or velocity, by adding silicone, rubber, spring, mesh, braid, fabric, or plastic dampeners. Creation of flutes, reliefs, friction, channels, dents, blisters, multiple holes or flow paths, and other dampening methods known to POSA.

[0278] An exemplary embodiment of disclosure is replacing the metallic leaflets with flexible tarp 1075 like leaflet concept is shown in FIG. 75B-J. FIG. 73B shows the top view of the frame 1405 with a stationary and rigid horizontal member 1410. In an alternate embodiment, the frame 1405 comprises of a skirt 1062. FIG. 73C shows the side view of the frame 1405. FIG. 75D shows the flexible, tarp 1075, leaflet-like material in the shape of circular disc. FIG. 75E shows the flexible disc like prosthetic leaflet 1075 bend and allow flow of blood. FIG. 75F shows the disc below the horizontal member, blocking the blood flow. Thus, acting as a one-way valve. POSA will appreciate that the only moving component of this device is the flexible bending of the tarp 1075. Thus, eliminating the risks of friction, wear. Furthermore, the frame can be made rigid (for surgical implantation). The tarp 1075 can be removably, replaceably, attached, sutured, and or bonded to the horizontal member 1410 and or to the frame 1405.

[0279] In an alternate embodiment, the prosthetic valve can be delivered and implanted via a catheter, by configuring the frame 1405, the horizontal member 1410, and the tarp 1420 to be sufficiently flexible, telescoping, lockable in two different states/positions, compressible, foldable, bendable and or assembled, including any means known to POSA. Any additional features such as arms, skirts, and visualizing, spacers, and/or leaflet cutting methods/embodiments discussed in this application or those known to POSA may be used to securely implant this device in the aortic valve.

[0280] In an alternate embodiment, the device frame 1405 can have a curved 1425 landing zone for the tarp 1075, configured to improve hemodynamics/hemocompatibility. FIG. 75G and 75H show states during systole and diastole, respectively.

[0281] In an alternate embodiment, the device frame 1405 can have a base with holes 1430, as in FIG. 751.

[0282] In an alternate embodiment, the device frame 1405 can have a base with any configuration or designs of flow pattern 1440, optimized for improved hemodynamics/hemocompatibility, as in FIG. 75J.

[0283] In alternate embodiments for FIG. 75E-FIG 75J can comprise of multiple (more than one) Leaflets/tarp 1075. The leaflet/Tarp 1075 in FIG. 75B-J can be single structure or multiple structures assembled together. The leaflet can be attached to the horizontal member 1410 or to the frame 1405 using any known fastening, gluing, welding, press-fitting, riveting, methods. Alternatively, the trap 1420 can be attached directly to the aorta, aortic leaflets. Alternatively, the trap 1420 can be attached directly or indirectly via a connecting feature to the combination or tissue, frame 1405, and/or horizontal member 1410. Alternatively, both the leaflet/Tarp 1075 as well as the horizontal feature 1410 may be configured to replaceable/ swappable as a single unit or independently, during the procedure (acute) and at a later date or time, for example, after 15 years.

[0284] Mitral Valve Devices and Methods:

[0285] Atraumatic Annulus Devices and Methods:

[0286] FIG. 76A-B is an disclosure for treating valve regurgitation, for example, heart valves such as mitral, tricuspid, and pulmonary valve. Nevertheless, this idea can be applied to any valve in the body. FIG. 76A shows schematic of a normal mitral valve.

[0287] FIG. 76B shows a diseased mitral valve with regurgitation caused due to annular dilatation. One exemplary solution/method/device of disclosure is to deploy at least one atraumatic ring, adjacent to the annulus. For example, a ring may be placed above (up stream) or below (down stream) the annulus. For example, a spiral ring may be placed over and under the annulus and/or leaflets. Let the tissue fully encapsulate the ring over an extended period of time (typically >30 days) In a follow-up procedure, return to progressively tighten/compress the ring in one or multiple visits, until the gap between the leaflets are reduced or fully closed, to mitigate regurgitation. [0288] In an alternate embodiment, the valve can be configured to auto-cinch over a period of time to a predetermined diameter or shape. This can be achieved by using biodegradable spacers, bio-degradable tube, biodegradable coating, or any other similar means, where in, the ring is held in an expanded state acute and over period of time, shrinks or compresses. One example of the disclosure is to insert a spring of known diameter, stretch it using a biodegradable tube or spacers, and insert it inside the ring cross-section. Over period of time, the tube or spacer degrades or dissolves and the spring compressed the ring to a pre-determined shape or size. Alternatively, the ring maybe filled with biodegradable material. Alternatively, a balloon maybe used to control the shape and size both acute and over period of time. Alternatively, remotely controlling motors, actuators, wireless, RF, fluidics, thermal, chemical, mechanical means may be used to remotely control the cinching. In an alternate example, material prosperities, such as creep, sublimation, etc can be used.

[0289] FIG. 77A shows side view of an exemplary ring based atraumatic annular cinching device 1510. In this exemplary design, a stent design cut from a tube is used and a typical compression spring 1530 of circular cross-section is fastened, welded, sutured, or interlaced. A POSA can understand, the ring by passing a string through the compression spring 1530, it can be compressed by cinching the string. While this is an exemplary method, any other method can be used to compress, change shape or size of the ring over period of time.

[0290] FIG. 77B shows top view of an exemplary ring based annular cinching device 1510. Alternate embodiments of these can be configured to be of any shape that can be closer to anatomical shapes such as D-shape or any patient specific profile.

[0291] FIG. 77C - FIG. 77H show various exemplary cross-sectional profiles ‘ A-A’ of the ring 1510. The ring 1510 can be made of compression spring with typical circular profile, a stent with a compression spring, a flattened compression spring with an oval, rectangular, triangular, trapezoidal, c-shaped, s-shaped or any other suitable profile. The compressible springs 1530 can be made of wire, sheet, tube, or 3D printed. It can have typical stent, braided, woven, coiled, or any suitable means. On the tissue interfacing side, the ring can have miniature barbs or other frictional elements that cause none or minimal trauma to the tissue, both acute (when repeatedly deployed and repositioned) or chronic (over period of time should not cause any ischemia, necrosis, conduction disruptions, etc.). This, unlike current technology, that uses cork screws to fasten deep (>1.5mm) into the tissue. In a preferred embodiment, the frictional elements or barbs are less than 1.5mm, 1.0mm, 0.75mm, 0.5mm, 0.25mm, 0.1mm, 0.01mm, and or 0.0001mm. [0292] FIG. 78A to FIG. 78D shows various exemplary embodiments of the rings 1510 made from wire, sheet, strips, or tube. Alternatively, they can be molded, 3D-printed, machined, laser cut, assembled, stitched, and or braided.

[0293] FIG. 79A - FIG. 79D show various exemplary shapes, such as ring, c-shape, d-shape. etc. These can be made of metal, plastic, ceramic, composite, laminar, monolithic, layered, assembled, covered, coated, spun wrapped, molded, over-molded, etc. The frictional elements can be knots, barbs, v, w, s, flat, or rounded edged barbs, rough surface, rough fabric, glue based, screws, barb anchors, or any other means known to POSA to securely attach to tissue, at least until the tissue encapsulation is complete. These frictional elements can be fully atraumatic (non-penetrating the tissue) or penetrating (with minimum trauma). Instead of one continuous structure, the device can be small segments, delinked or linked chain, that can be assembled in the body or at the OR table. Sutures, strings, magnets, pull wires and any suitable technique based on the device segment configuration maybe used to assemble or dissemble, to enable loading inside the catheter. The re-capture, retrieval, re-adjustment features can be radio-active, radio-opaque, echogenic, rf id, or any means to improve visualization, commonly known to POSA.

[0294] In an exemplary alternate embodiment, the ring 1510 may be configured to initially appose the annulus gently over a sufficiently adequate period (for example 30 days, 60 days, and or 360 days) to ensure complete tissue encapsulation, and then, start cinching to accelerate reversed remodeling of the heart/annulus. This may be achieved via any of the known methods to POSA, for example, a) using time tailored biodegradable materials embedded in a spring of a smaller diameter, b) biodegradable material embedded in a shape set nitinol material of desired final annulus shape, c) nitinol motor, d) pneumatic, fluidic control, e) manual cinching via a catheter, to cinch the ring 1510 post tissue encapsulation.

[0295] FIG. 80A - FIG. 80L show an exemplary method of mitral valve annulus repair. FIG. 80A shows a diseased mitral valve with dilated annuls and a gap G in the mitral leaflets, causing MR. A guidewire 1005 is first introduced using transeptal route. Typically, the guidewire is passed via femoral vein access point, up through the Inferior Vena Cava, into the right atrium, and finally into the left atrium on passing through the septa. Alternatively, left atrium can be accessed from jugular vein. Alternatively, it can be accessed from the femoral artery, aortic valve, left ventricle and then left atrium.

[0296] FIG. 80B shows the catheter inserted over the guidewire into the left atrium. The guidewire may optionally be retracted and removed, once the catheter is in place. The ring 1510 is loaded in folded configuration and is shown being pushed out. Alternatively, the ring can be compressed or both compressed and folded. Other alternate means can be straightening it in the catheter, in case of a c-shape. Alternatively, any means to load a device, commonly used in catheter anywhere in the body may be used. One advantage of this disclosure may be that it allows for the stent to be folded, flattened, and loaded along the length, thereby, reducing the cross-section of the catheter. Additionally, it can be curved to further reduce the profile of the catheter. Typically, stents are compressed radially/circumferentially, which increases the size of the catheter.

[0297] FIG. 80C shows the device 1510 fully out in its expanded state. The device can be detachably held in to the delivery catheter 1550 using commonly used catheter techniques such as sutures, wires, tubes, etc. For example, FIG. 80C shows the device is being held using detachable radial sutures that pass through tube 1580. The adjustable/retrieval feature 1540 is being connected via torque cable 1570.

[0298] FIG. 80D shows the device 1510 in shrunk (compressed) state. This can be achieved either by pulling in the radial sutures 1560 via tube 1580 or by actuating feature 1570. Actuation of feature 1570 can be via turning, rotating, pulling, cinching, inflation/deflation, pneumatic, rf, remote, wireless, electrical, electronic, motorized, geared, toothed, etc.

[0299] FIG. 80E shows the device 1510 flush with the catheter 1550. This can be done by retracting the tube 1580.

[0300] FIG. 80F shows the device 1510 positioned above the valve by steering the catheter 1550.

[0301] FIG. 80G shows the device 1510 in expanded state. The extent of expansion can be controlled either be pre-sizing the device 1510 prior to selecting the size using known catheter techniques such as echocardiography for example. Alternatively, a smart force sensor or size sensor, or surface contact sensor of mechanical, electrical or fluidic, imaging, for example, may be used to ensure proper apposition and placement.

[0302] Controlled apposition can be achieved either by actuating 1570 or by pulling in the radial sutures 1560 via tube 1580.

[0303] FIG. 80H show alternate and optional method of ensuring apposition by using a balloon, which is inflated to compress the device 1510 against the atrial valve / Orifice. This compression can also be used to securely insert/engage the atraumatic frictional elements to the annulus / tissue.

[0304] FIG. 801 shows the device 1510 implanted. All delivery system has been detached and removed. Optionally, in an alternate embodiment, the actuating feature 1570 can be left attached to the implant and secured transcutaneously or subcutaneously for continued access to adjustment. Optionally, the actuation feature 1570 can be incorporated with sensors to continuously assess the regurgitation. Post sufficient time for robust tissue encapsulation of the device 1510, it can be cinched to reduce the gap between the leaflets, as shown in FIG. 80K. Note, this cinching can be done over a period of time (once a day, week, month or year) or all at once. Alternatively, some controlled cinching can be configured via elastic recoil of the material or other material properties. In an alternate method, the ring 1510 can be configured to be easily cinched but harder to expand or using superelastic materials with hysteresis (different plateaus) or interlocking mechanisms that prefer cinching to expansion.

[0305] FIG. 80L shows the final state of the device 1510 with complete treatment or mitigation of the regurgitation.

[0306] FIG. 81 A - FIG. 81C show exemplary embodiments of manipulating the ring 1510 using nitinol strips that are laser cut form a tube. FIG. 81 A shows the ring 1510 held in expanded position, similar to FIG. 80F. FIG. 8 IB shows the nitinol strips. As known to POSA, the strips are shape set in an funnel like shape and hence, will expand and contract, when pulled in or out of the catheter shaft 1550. Further, each of the strip can be individually or simultaneously controlled using sutures 1560, to both steer and or to attach/detach the ring 1510 to the strips 1590. FIG. 81C show the laser cut tube pattern with suture holes for steerability and ring securing features.

[0307] FIG. 81D show an exemplary embodiment of an atraumatic anchors 1595, similar to a staple. FIG. 81E shows an alternate embodiment with a loop that allows sutures to pass through or provides an attachment feature. For example, the loop can be used for mounting, cinching, actuating and or deploying. FIG. 81F shows an alternate embodiment of an atraumatic anchor that engages the tissue by expanding.

[0308] One advantage of this disclosure may be that the device 1510 allows for multimodality treatment, for example, disclosure allows or is compatible with edge-to-edge repair and chordal repair. One advantage of this disclosure may be that annulus repair can be done before or after edge-to-edge or chordal repair. One advantage of this disclosure may be that the device 1510 allows for multimodality treatment, for example, disclosure allows or is compatible prosthetic valve replacement. One advantage of this disclosure may be that Orifice repair can be done before or after valve replacement. One advantage of this disclosure may be that annular repair forms a scaffolding for the replacement valve.

[0309] One advantage of this disclosure may be that it allows for chronic cinching over period of time, preferably after a lag time of 30 days. [0310] One advantage of this disclosure may be that by using outward force (such as a balloon, as described in FIG. 80H), frictional elements (barbs, coils, screws, anchors and or wires) can be securely inserted into the annular tissue, thus allowing for acute cinching and or chronic cinching, without the risk of dislodgement.

[0311] One advantage of this disclosure may be that the frictional elements can be pushed in, or twist or rotated to engage with the tissue.

[0312] In one exemplary method, the ring 1510 contains minimally penetrating (preferably less than 1.5mm, 1.0mm, 0.5mm, 0.25mm, and or 0.1 mm) frictional elements is inserted into the left atrium, the ring is then positioned about the annulus under standard fluoroscopy and echo guidance. The ring’s frictional elements are anchored into the tissue via a balloon 1585 or by twisting/rotating/pulling/pushing the rings to securely engage or attach it to the annulus. The ring is then deployed, resulting in one or two step cinching (acute and/or chronic). Acute cinching can be configured via natural elastic recoil of any elastic material when expanded. Chronic cinching can be configured via one-way preferred progressive cinching following the nature expansion and contraction of the beating heart, or via remote controlled cinching or biodegradable controlled cinching.

[0313] Leaflet Augmentation Devices and Methods:

[0314] FIG. 82A shows an annulus stent 1510 combined with an expandable member 1805 that is first poked through the leaflet surface from the atrial side to the ventricular side and then expanded to support/augment the leaflet.

[0315] FIG. 82B shows a cinchable annulus stent 1510 combined with an expandable or foldable member 1810 that is first poked through the leaflet surface from the atrial side to the ventricular side and then expanded to support/augment the leaflet.

[0316] FIG. 82C shows an atraumatic annulus stent 1510 combined with an expandable or foldable or arm feature 1820 with features to grasp the leaflet from both atrial and or ventricular sides. The grasping feature can be actuatable. The feature 1820 can be configured to be hinged, bendably attached or tethered to the annulus stent 1812, allowing it to swivel/beat along the native leaflets (retaining the normal leaflet motion). The feature 1820 can optionally comprise of a leaf spring (similar to arms and grippers of co-owned patents), a foldable sheet, a spacer, a prosthetic valve. Any combination of the above exemplary embodiments listed in the provisional or referenced patents or co-owned patents may be interchangeably applied to create new embodiments. [0317] FIG. 83A and 83B show atrial and side view respectively of the mitral valve prosthetic leaflet augmenting feature 1820 with swiveling/beating leaflets paired with an annular stent 1510. The valve is in an open (systolic) position.

[0318] FIG. 83C and 83D show atrial and side view respectively of the mitral valve prosthetic leaflet augmenting feature 1820 with swiveling/beating leaflets paired with an annular stent 1510. The valve is in a closed (diastolic) position.

[0319] FIG. 83E show atrial and side view respectively of an alternate embodiment of the mitral valve prosthetic leaflet augmenting feature 1820 with one swiveling/beating leaflet 1820 and one stationary leaflet 1820 paired with an atraumatic and compressible annular stent 1510. The valve is in an open (systolic) position.

[0320] FIG. 83F show atrial and side view respectively of an alternate embodiment of the mitral valve prosthetic leaflet augmenting feature 1820 from FIG. 83E, with one swiveling/beating leaflet 1820 and one stationary leaflet 1820 paired with an annular stent 1510. The valve is in a closed (diastolic) position.

[0321] As is obvious to a POSA, either of the leaflet features (swiveling or fixed) can comprise of leaflet augmenting features such as spacers, prosthetic leaflets, leaf springs. The commonly used items such as Japanese fan design, fabric, braid, balloon, nitinol, biodegradable materials may be used. These features can be rigid or flexible and mimic motion and flexion of natural native leaflets.

[0322] The swiveling leaflet augmenting feature maybe attached to any one or more leaflets. The leaflet augmenting feature can be attached to the posterior leaflet of the mitral valve or alternatively be attached to the anterior leaflet, or both. The augmenting feature may also lengthen or fill the holes and clefts in native leaflets, increasing leaflet functionality and efficacy.

[0323] This leaflet augmentation feature is attached to a highly compliant nitinol stent 1510 that gently opposes the annulus with 0-15 percent expansion at most. Additionally, the stent may have a component such as a suture, wire, or spring around it’ s circumference to prevent too much expansion. Once tissue is grown and it is completely encapsulated, the stent is firmly attached to the annulus, and allows reverse remodeling (annulus to revert to natural state) to take place. This stent may be used alone as well. Additionally, the stent may be used alongside another device which shrinks the annulus as it is able to shrink, unlike current devices which are too stiff. The stent may either break up over a period of time with use of biodegradable materials, or stay in place, but have such low outward force on the annulus that reverse remodeling of the annulus is not hindered, and the stent is pushed inwards. The high compliance of the stent additionally prevents trauma on the annulus due to less forces opposing the tissue walls.

[0324] The stent may also act as a scaffolding for valve replacement therapies as it does not expand greatly, acting as tissue does, and creating a snug ring for the valve replacement device to fit into.

[0325] Al may be used to indicate the compliancy needed on each stent according to the size of the annulus. Alternatively, it may be shaped to apply more pressure at areas of the annulus that are more significantly receded.

[0326] Referenced herein and incorporated in full, EP3912595 (FIG. 84A) and US11083572B2 (FIG. 84B) family. EP3912595 shows a leaflet augmentation, however, lacks annulus cinching and a spacer. US11083572B2 shows spacer attached to annular frame, however, the frame does not cinch and the leaflet augmenting feature/ spacer does not swivel.

[0327] FIG. 85A -FIG. 85C show exemplary embodiments of cinchable annular rings 1510 paired with swiveling/beating leaflet augmentation features, with or without spacers. Swiveling leaflet augmentation features 1820 highlight a unique advantage of this innovation. Pairing the swiveling leaflet augmentation with cinchable atraumatic ring 1510 highlights another unique advantage of disclosure. Another advantage of this disclosure may be that the leaflet augmentation feature is actuatable (see referenced co-owned patents) to securely grasp the leaflets using frictional elements comprising of tiny <lmm barbs).

[0328] FIG. 86A and FIG. 86B show alternate exemplary embodiments comprising of cinchable ring 1510, leaflet augmentation feature 1820 with secondary prosthetic leaflets 1825.

[0329] In all of these embodiments, the annular feature can be cinched during or post procedure, pre or post tissue encapsulation. One advantage of having a cinching feature in the annular stent is to off load it fully or partially of the in-vivo loads or strains to the cinching suture/tether/strap/mechanism/feature.

[0330] In all of these embodiments, the cinching of annulus can be done gradually and progressively to take advantage of tissue adhesion and encapsulation of the device, thereby, mitigating trauma due to high acute forces on the anchor (as in current device, where the annulus is immediately cinched during the procedure). Additionally, allowing atraumatic anchor or anchorless device designs to minimize or eliminate tissue trauma to the annulus or its vicinity.

[0331] Anti-Calcification Vascular Devices and Methods:

[0332] FIG. 87 shows multiple exemplary embodiments comprising of individual or pairs of Electro Magnetic Pulse/Wave (EMP) feature 1910 wrapped over body sites. The feature 1910 may comprise of coils, solenoids, windings, mesh, braids, fabric, conductive paths, wires, ions, electromagnetic waves, antenna cables, radiation, energy, and other known electronic systems. An alternate embodiment comprises of at least one coil feature 1910 or one pair of coil feature 1910 that generates desired EMP. An alternate embodiment these coil feature 1910 may be part of a sleave, clothing, pad, adhesive patch, patch, and or bandage. The duration of treatment can be from a few seconds, days, weeks, months, years, and or decades. The treatment can be continuous or intermittent.

[0333] In an alternate embodiment, the coils may be placed outside or inside the blood vessel. Placement inside the blood vessel can be similar to stent placement using a catheter. In an alternate embodiment, the coil can be placed in the vicinity of the tissue or organ (for example gall bladder, kidney, urinary bladder, heart valve, coronary artery, etc).

[0334] The current shock- wave therapy incorporates high power pulse generator that is a safety risk. Some of the new art shows the advantages of using interference pattern to combine two Shock Wave Generators (SWGs) to increase the power via positive interference.

[0335] An advantage of this disclosure comprises of generating desired energy of Shock Wave (SW) at the treatment site, using lower overall energy, by focusing and or steering the beam energy using acoustic reflectors (AR) or matching layers (ML). Acoustic reflectors are typically air or other materials that have high acoustic impedance mismatch, as air and blood/urine/saline interface. For example, a POSA will know that a balloon inflated using gas in blood vessel will result in total reflection of the shock wave. While, matching layers have acoustic impedance that are comparable or close to each medium, resulting in up to 100% transmittance and 0% reflection.

[0336] FIG. 88 shows an exemplary embodiment of the shockwave generator/transducer that uses energy from electrical spark in saline between two electrodes to generate shockwaves. This entire housing may optionally be configured inside or outside of a catheter or catheter balloon. The backing layer can be configured as a reflector (R) or dampener or a combination of thereof. The backing layer can be used to focus, spread, steer, or create interference pattern of the SW. It can be curved, straight, continuous, in blocks, identical, matching, variable, or different acoustic impendence or beam forming properties. The matching layer can be used to maximize the transfer of SW energy to the target tissue. Further, the matching layer can be optional. When the SWG (and optionally configured with R and ML) is used without balloon, the energy can be created and transferred by flushing the space with compatible fluid, such as saline.

[0337] FIG. 89 shows an exemplary embodiment of focusing the shockwave energy using a balloon reflector. For example, a primary balloon 1950 is filled with liquid 1920, while a secondary balloon 1960 is filled with gas 1930, creating an acoustic reflector. The surface of the secondary balloon 1960 can be configured to focus 1940 the shockwave emanating from the shockwave generators SWG, as shown in FIG. 89.

[0338] In one exemplary method, the balloon catheter 1970 is inserted using typical interventional procedure techniques at the site of disease. The balloon 1950 is then inflated and the secondary balloon 1960 in inflated. The steerable secondary catheter 1980 is then steered to bring secondary balloon 1960 in position. A low energy test shockwave or finite element analysis (FEA), or artificial intelligence (Al) may be used to confirm the focus. The shockwave energy is then delivered to site.

[0339] In some embodiments, the secondary balloon 1960 may be preconfigured in a specific position relative to the guidewire tubing 1990 and the shockwave generators SWG. The secondary balloon 1960 may optionally be fixed in translation, however, free in rotation.

[0340] In some embodiments, the secondary balloon 1960 can be real-time or pre-configurable manually, via FEA, via Al, have user adjustable focus, and have support structures to be well supported and to prevent any displacement under the shockwave energy.

[0341] SW may be created via spark, ultrasound transducers, laser, flammable or explosive material/fluid/gas, and or any implosion or explosion that creates SW. Alternatively, a phased array of SWGs can be programed to generate steerable and focused SW.

[0342] An advantage of this disclosure may be that the focusing method/devices disclosed in this application and in FIG. 89 can be applied to any of the embodiments describe in US11432834B2, US11622780B2, US11696799B2, US11766271B2, US20210338258A1, US9867629B2, US10555744B2, US20230329731, US20230380849, US20230404605, US20240008886, US11950793, WO/2022/094523, 20220015785, US11779363, US20230310073, US11771449, all of which are incorporated here in their entirety by reference.

[0343] Visualization for Interventional Procedures:

[0344] FIG. 90 shows an exemplary embodiment of a catheter-based balloon 2015 with a camera 2010 mounted on the internal tubing 2020. The balloon 2015 can be inflated with clear liquid or gas, or saline 1920. As POSA can understand, the camera 2010 can be configured to be rotated and translated along the internal tubing 2020.

[0345] FIG. 91 shows an exemplary embodiment of a catheter-based balloon 2015 and comprising of a camera 2010 mounted on a steerable shaft 2030, within the balloon 2015.

[0346] One application where optical visualization can help, for example, is during disruption of plaque when using shockwave therapy. However, there is a potential for the shockwaves to damage the camera. [0347] FIG. 92 shows an exemplary embodiment configured for shockwave or calcium stones or plaque disruption, comprising of; a catheter-based balloon comprises of shock wave generators SWGs and is filled with clear liquid 1920; a balloon 2050 mounted on a steerable shaft 2030 inside the balloon 2015; and a camera 2010 inside the balloon 2050. As know to POSA, if the balloon 2050 is filled with clear gas, while the primary balloon is filled with liquid, the shockwaves will not be able to pass through and reflect way from gas filled secondary balloon 2050 due to acoustic mismatch, thereby, mitigating any damage to the camera 2010.

[0348] An advantage of this disclosure may be that the visualization method/devices in application and in FIG. 92 can be applied to any of the embodiments describe in US11432834B2, US11622780B2, US11696799B2, US11766271B2, US20210338258A1, US9867629B2, US10555744B2, US20230329731, US20230380849, US20230404605, US20240008886, US11950793, WO/2022/094523, 20220015785, US11779363, US20230310073, US11771449, all of which are incorporated here in their entirety by reference. [0349] FIG. 93 shows the FIG. 90 embodiment within a blood vessel wall.

[0350] FIG. 94 shows an alternate embodiment of FIG. 91, wherein, the balloon 2015 comprises of sealable ports 2080, through with robotic catheters 2070 or interventional device catheters 2070 can be advanced outside of the balloon to perform desired interventions. The steerable camera shaft 2030 and camera 2010 can optionally advanced through the same or different port 2080. Note: two such ports 2080 are shown and vessel wall 2060 is not shown for simplicity in FIG. 94.

[0351] FIG. 95 shows an alternate exemplary embodiment, wherein, 2 collapsible, self-opening umbrella like sealers 2110, which are part of a blood flow diverter catheter 2030 are used. The umbrella sealer 2110 can be self-opening when push out of a catheter or sheath 2100, and will retract when pulled back into the catheter sheath 2100. The flow diverter catheter ports 2095, where blood can pass through 2090 and come out downstream through the distal sealer 2110. The flow diverter catheter 2130 and additionally comprise of saline ports 2120 through which saline 1920 can be continuously flushed to create a clear see through optical medium. In and exemplary embodiment, a steerable sheath 2030 with camera 2010 can be used. While not shown, robotic and other device catheters may be used to perform the procedure inside or outside the vessel lumen, as evident to POSA.

[0352] FIG. 96 shows an alternate exemplary embodiment, wherein, an umbrella sealer 2110 provides a seal against the side wall, to provide a saline flushed, blood free pocket. The sealer may have actuatable anchors, removable anchors, active anchors, suction, and or any other means to actively create a seal against the wall. Alternatively, the sealer may passively seal against the wall by deploying support props, secondary balloon, or a separate cage, backing support against back wall, stiffer catheter, curving to create push from opposite/ back vessel wall or structure, stent structure, self-expanding cage/ stent structure, increased saline flow/flush for positive pressure displacement (pressure slightly higher than blood pressure), increased recycling of saline by suctioning old saline and flushing new saline continuously or intermittently, and or any other means available to POSA for providing adequate apposition and blood free zone. This blood free zone can then be utilized for performing procedures under visual guidance using a camera 2010 using manual, robotic surgery 2070, Al assist, FEA assist and or similar techniques known to POSA in endoscopy procedures may be adopted now, advantageously in catheter interventions within or beyond the lumen of the blood vessel/ organ/ti ssue/ cell .

[0353] FIG. 97 shows an alternate embodiment described in FIG. 95, wherein, seals are achieved using balloons 2140, in place of umbrella like seals 2110.

[0354] POSA can appreciate that reinforced support structures within or outside the balloon 2015, 2050 or within and outside any relevant structures/components, to support key features, such as camera, allowing low profile when deflated. For example, using sutures or fiber reinforcements/web inside the balloon 2015 and expandable stent structures outside of the balloon 2015 (and or sealer 2110), and or using a separate secondary catheter to provide external support.

[0355] POSA will also appreciate that flow diversion is not always required. This, as temporarily stopping blood supply to non-critical regions may be deemed safe. In such scenarios, the use of flow diversion (via ports 2095) is optional and blood free zone may be achieved via upstream sealers with or without down stream sealing, and with saline flush alone, for a short time period or intermittent creation of blood free zone.

[0356] One another advantage of this disclosure may be that by using Al, simulation, and robotics, the blood free zone creation steps can be programmed to take place automatically, when requested by the surgeon, or when visual confirmation/feedback is required. This enables to the physician to concentrate on the procedure and relieve him from performing non-value added tasks. Additionally, in extended procedural times, the location or pressure of the seal can be moved or adjusted to ensure no trauma due to pressure at the seals or blood flow compromise. POSA is aware that critical sensor may be incorporated within the procedure to monitor the patient’s well being at all time using integrated sensors within the visualization system or externally using standard patient monitoring methods used during robotic, interventional, or standard medical procedures. [0357] A prosthetic aortic valve that grasps onto leaflets using actuatable arms and grippers to significantly reduce the risk of device migration and device size. The methods and embodiments involve cutting the diseased leaflets prior to prosthetic valve implantation while maintaining flow to coronary arteries during the procedure, with the option of optical visualization. The prosthetic valve embodiments comprise replaceable leaflets and a low-profile frame. Additionally, there are methods and embodiments for novel left atrial appendage devices that maximize the retention of the appendage’s functionality while minimizing the risk of thromboembolization and heart arrhythmia. Methods and embodiments of embolic protection devices that minimizes embolization risks. Intra-cardiac echocardiography devices that can be assembled inside the body to increase the transducer size, thereby improving the resolution and quality of the images. Novel steerable catheter devices that enhance steerability and compatibility with robotic surgery. Atraumatic and cinchable mitral valve annular repair devices with beating prosthetic leaflet augmentation. Noninvasive or interventional methods and devices that modify body calcium using electromagnetic energy. Systems, methods, and embodiments that enable optical visualization in vascular interventions by diverting and or displacing blood with clear fluid, while maintaining perfusion.

REFERENCE SIGNS LIST

The following is a listing of the reference numbers/signs used in this application:

Left Atrial Appendage Occlusion Devices and Methods:

Intra-Cardiac Echocardiography Devices and Methods:

GENERAL CONSIDERATIONS

[0358] As one of skill in the art would appreciate, the various examples, methods, embodiments, references incorporated, and aspects described and claimed herein can be combined in part or in whole throughout this application without any limitations, irrespective of the sections, headings, or technical field. [0359] The methods, apparatuses, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present, or problems be solved. For all of the embodiments described, the steps of any methods need not be performed sequentially.

[0360] As used herein, the term "and/or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, and/or C" means "A," "B," "C," "A and B," "A and C," "B and C" or "A, B and C."

[0361] As used herein, the term "and/or" used between the last two of a list of elements means any one or more combinations of the listed elements. For example, the phrase "1, 2, 3, ... 9, and or 10" means “1”, “2”, “3” and so on until “10”, or between “1 and 2”, “1 and 3”, and so on to between “1 and 10” or between any other combination of the numbers from “1 to 10”, for example, the value can be between 8 and 10.

[0362] As used herein, the term "connected" or “fastened” generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items absent specific contrary language.

[0363] All ideas, methods, embodiments, are presented in consideration with current and future technological advancements, for example, for use with robotics, Al, hardware, software, performing procedures in person, remotely, and or program driven, with or without human intervention.

[0364] All implant embodiments described in disclosure may be optionally covered, wrapped, coated, or the like to improve biocompatibility and tissue interface. Suitable coverings can be fabric, web, fibrous, braid, woven or non-woven. The coatings can be metallic, ceramic, polymeric, or combinations thereof. Suitable metallic coatings include titanium, TiN, tantalum, gold, platinum, and alloys thereof. Suitable ceramic and inorganic coatings include titanium dioxide, hydroxyapatite, CaP, and the like. Suitable polymeric coatings include fluoropolymers, e.g. PTFE, PF A, FEP, ECTFE, ETFE; parylene, polyester, PET, polypropylene, polyurethane, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, THV, and the like. Suitable biodegradable include poly(lactic acid), poly(glycolic acid), polydioxanone, polyp- caprolactone), polyanhydride, poly(ortho ester), copoly(ether-ester), polyamide, polylactone, polypropylene fumarate), and their combinations. Such metallic, ceramic and/or polymeric coatings are listed as examples only. Any suitable metal, ceramic, polymer, and combination thereof may be used to produce a desirable coating.

[0365] All references mentioned in this entire specification are incorporated here in their entirety, wherein, any of these reference devices or methods may be used as whole or in part, or in combination with other referenced devices in full or in part, modified innovatively, as relevant and understood by a person skilled in the art, in the spirit of this disclosure.

Claims

1. A method of implanting an aortic heart valve, the method comprising: a. deploying one or more temporary valves within an aorta of a patient; b. establishing a blood path to supply coronary arteries of the patient while the temporary valve is in place; c. implanting a prosthetic valve within the aorta of the patient, the prosthetic valve comprising actuating arms and or grippers; and d. actuating the actuating arms independently or simultaneously of the prosthetic valve to securely grasp aortic leaflets of the patient.

2. The method of claim 1, further comprising: a. deploying temporary valves above and below the native heart valve; b. establishing a flow path between the two temporary valves, thereby creating a space with no blood flow at the native valve; c. establishing a continuous optically clear fluid flush within the space; and d. using an optical camera to visualize the aortic valve region to aid the procedure.

3. The method of claim 2, further comprising: a. using a heart pump to aid flow between the two temporary valves.

4. The method of claim 1, further comprising: a. cutting of diseased heart valve leaflets to create space for the prosthetic valve

5. The method of claim 2, further comprising: a. cutting of existing prosthetic valve leaflets to create space for the new prosthetic valve.

6. The method of claim 3, further comprising a. cutting of existing prosthetic heart valve to create space for the new prosthetic valve.

7. The method of claim 1, further comprising: a. implanting the prosthetic valve at the level of the native aortic leaflets and below the coronary artery ostia.

8. The method of claim 1, further comprising: a. implanting the prosthetic valve above/ downstream to the native aortic leaflets and above/downstream to the coronary artery ostia; and b. establishing flow to coronary arteries.

9. The method of claim 1, further comprising: a. deploying one or more temporary filter within an aorta of a patient;

10. The method of claim 1, further comprising: a. implanting the prosthetic valve device that comprises of a frame with actuatable arms and a modular insertable and replaceable prosthetic leaflets that can be removed and replaced at a later date, post procedure.

11. The method of claim 1, further comprising: a. implanting a prosthetic valve with a frame of higher compliance, to reduce trauma and retain normal tissue compliance.

12. The method of claim 1, further comprising deploying the prosthetic valve with actuating arms to secure against the native valve wall, annulus, or leaflets.

13. The method of claim 1, further comprising deploying the prosthetic valve with optical visualization using a camera, primarily or in addition to other modes of visualization.

14. The method of claim 1, further comprising a deployment system, wherein the leaflets or the entirety of a failed prosthetic valve is cut using a cutter to make room for new valve in valve prosthetic device.

15. The method of claim 1, further comprising a deployment system, wherein diseased and stenosed native leaflets is cut to make room for new valve in valve prosthetic device.

16. A device comprising a prosthetic valve with actuatable arms which can be sequentially or simultaneously actuated to grasp the native leaflets reversibly and repeatedly, while the prosthetic valve is fully expanded state.

17. An aortic prosthetic device with leaflet grasping arms attached comprising a superelastic material such as nitinol, or metal, plastic, ceramic or their combination and a lever arm used for mechanical advantage that can be attached to prosthetic valve using a feature such as a suture, a hinge, weld, glue, screw, or rivet. The arms can have barbs or other frictional elements to securely grasp the leaflets. The device can be repositioned, redeployed, or removed, by actuating the arms, if necessary.

18. The aortic prosthetic device in any of the preceding claims, wherein the prosthetic valve can be repositioned, deployed and assessed multiple times in its fully expanded state.

19. The aortic prosthetic device in any of the preceding claims wherein, the arms are multiple components configured to be biased towards each other attached at their base or anywhere between the arm and the device, allowing for the arms to be raised or rotated with components such as a suture, screw mechanism, hydraulic, electrical, chemical, pneumatic, etc.

20. A replaceable prosthetic leaflet device comprising a valve housing with fixation/attachment features to removable attached to features such as a frame, arms, and a skirt, that can remaining fixed to the surrounding tissue post implantation.

21. The replaceable prosthetic leaflet design in any of the claims wherein, the skirt is a hollow, balloon, stent with a cover, or any structure with a cover, an expandable and compressible structure, perforated structure, fabric, braid, film, coating, cushion, sponge, sponge like structure, or any structure that can prevent blood leaks.

22. The replaceable prosthetic leaflet design in any of the claims wherein, one or more retrievable features such as suture loop, a hook, magnet, threads, or any commonly known features that aid retrieval of device post implantation (see co-owned patent for additional details). The retrievable features can also be actuatable, deployable, or remotely triggerable.

23. The replaceable prosthetic leaflet design in any of the claims wherein, retrievable features is placed both on the replaceable valve and valve housing so the features on the replaceable valve is used to detach, remove, and replace the valve housing which comprises stabilizers such as the studs, hooks, or slots.

24. The replaceable prosthetic valve system in any of the claims wherein, the leaflets are designed/configured to be tearable valve leaflets and or optionally housed in a secondary frame, to easily remove it (similar to modular or cassette designs). Once removed the new secondary frame with new valves can be fit inside the permanent prosthetic valve frame.

25. The replaceable prosthetic leaflet design in any of the claims wherein, the replaceable valve has a retrievable feature to pull the failed leaflets out of the slot of the valve housing. The new replaceable valve can then be press fit inside the valve housing by using a balloon. Once secure, the balloon is removed.

26. The replaceable prosthetic leaflet design in any of the claims wherein, the replaceable valve has a snap-fit, elastic, super elastic fit, twist fit, and or screw fit.

27. The replaceable prosthetic leaflet design in any of the claims wherein, the replaceable valve can reversibly be secured or removed using ultrasonic, laser, thermal, UV, glue, friction, conical/pin fit, and/or mechanical fit.

28. The replaceable prosthetic leaflet design in any of the claims wherein, a spacer is used to mitigate regurgitation.

29. The replaceable prosthetic leaflet design in any of the claims wherein the shape and cross-section can be any geometric shape, including a cylindrical, star, triangular, flat, crescent, ellipsoidal, etc. Further, the spacer can be expandable, compressible, stretchable, inflatable, porous, solid, wire form, or sponge.

30. The replaceable prosthetic leaflet design in any of the claims wherein, a tarp, leaflet, or disc is used to mitigate regurgitation.

31. The replaceable prosthetic leaflet design in any of the claims wherein the tarp can be flexible, rigid, stretchable, non-stretchable, hollow, balloon, stent with a cover, or any structure with a cover, an expandable and compressible structure, perforated structure, fabric, braid, film, mesh, fibrous, coated, cushion, sponge, sponge like structure, or any structure that can mitigate valve regurgitation when placed over the gap between the leaflets.

32. The replaceable prosthetic leaflet design in any of the claims wherein the tarp can be made of metal, plastic, biological origin, non-biological origin, ceramic, superelastic, shape memory, composite, fabric, braid, machined, 3d printed, or any combination known to POSA.

33. The replaceable prosthetic leaflet design in any of the claims, wherein the tarp can comprise of at least one structure, 2 structures or 3 or more structures. It can have single leaflet covering, double leaflet covering, or 3 or more leaflet covering.

34. The replaceable prosthetic leaflet design in any of the claims wherein the tarp can be of any shape, circular, pizza, triangular, trapezoid, square, oval, and so on. It can be corrugated, folded, smooth, fan like bladed structure, Japanese foldable fan like structure, with slits or without any slits. The tarp can have features, stiffening members, wires, sheets, along the rim and sides to configure and optimize the shape during diastole (to minimize regurgitation) and during systole (to maximize blood flow).

35. The replaceable prosthetic leaflet design in any of the claims wherein, the mechanical prosthetic valve includes a coating, fabric, or braid that promotes tissue encapsulation and endothelization of the leaflets and valve body, to mitigate the need for blood thinners.

36. The replaceable prosthetic leaflet design in any of the claims wherein, the mechanical prosthetic valve includes rubber like soft seal, to mitigate the valve opening and closing, clicking noise. The soft seal is achieved with use of a polymer O-ring, seating, tissue growth, or fabric cushion.

37. The replaceable prosthetic leaflet design in any of the claims wherein, the mechanical prosthetic valve uses polymer leaflets instead of metallic leaflets, for example, with polypropylene of polyurethane leaflets.

38. The replaceable prosthetic leaflet design in any of the claims wherein, the prosthetic mechanical valve comprises of uni-structure leaflets that bend/flex to open or close, instead of a hinged and two or more leaflets in typical mechanical valve

39. The replaceable prosthetic leaflet design in any of the claims wherein, the prosthetic mechanical valve comprises of 3D printed composite leaflets designed to mitigate the need for blood thinners and clicking noise. The 3D printed composite leaflet will have a cushioned seating when closing.

40. The replaceable prosthetic leaflet design in any of the claims wherein, a filter comprising of a mesh and a self-sealing or sealable port to advance various catheters can be placed downstream of the coronary sinus, in which case, debris free blood to the coronaries can be provided using tubes. The seal of the blood flow to coronary is achieved using commonly known means, including a snug fit tube, tapered tube, inflatable or spongy cuff, a stent, O-ring, etc.

41. The replaceable prosthetic leaflet design in any of the claims wherein, the functions of filter and temporary valve can be combined into a single embodiment.

42. A prosthetic device with the spacer in any of the claims wherein, the spacer is smart, and the shape is changed remotely electronically or hydraulically, or mechanically or chemically but not limited to these examples.

43. A prosthetic valve with retrievable features in any of the claims wherein, they optionally have features that aid in detection, for example radio-opaque, echogenic, magnetic, florescent, etc., and wherein the features can be of polymer, metal, ceramic, nitinol, etc.

44. A method of using the temporary valve in any of the claims wherein, the temporary valve is switchable between a two-way valve (flow in both directions).

45. The method of using the temporary valve as claimed in any of the preceding claims, wherein the temporary valve is switchable between a two-way valve using one or more of the following mechanisms: mechanically, electrically, electronically, chemically, magnetically, using software, or via a fluidic trigger

46. The method of using the temporary valve as claimed in any of the preceding claims, wherein a temporary one- way- valve is placed upstream to the valve so that blood flow to the coronary arteries is not compromised if removal of a failed prosthetic valve or cutting of prosthetic leaflets is required.

47. The method of using the temporary valve in any of the claims wherein, a cuff which can be a balloon, hemispheric, concave, cup shaped, bowl shaped, expandable umbrella like structure, disc, stent, or any feature is configured to restrict blood flow when deployed.

48. The method of using the temporary valve and a cuff seen in any of the claims wherein, such that the cuff has a port that is used to flush the working zone around the failed valve with clear, translucent, or transparent liquid such as heparinized saline, to aid visualization using cameras or optical techniques.

49. An annular ring cinching device wherein a stent design is laser cut from a tube is used as a typical compression spring of circular cross-section is fastened, welded, sutured, or interlaced, wherein the ring can be passed through a compression spring and compressed by cinching the string, wherein the ring is made of a compression spring with typical circular profile, a stent with a compression spring, a flattened compression spring with an oval, rectangular, triangular, trapezoidal, c-shaped, s-shaped or any other suitable profile, and wherein the compressible springs can be made of wire, sheet, tube, or 3D printed. It can have typical stent, braided, woven, coiled, or any suitable means.

50. The annular ring cinching device in any of the claims wherein, the ring comprises of barbs or other frictional elements of depth less than 2mm, 1.5mm, 1mm, 0.5mm, 0.25mm, 0.1mm, and or 0.001mm, for atraumatic engagement with tissue and or minimal trauma to the tissue.

51. A method of deploying the prosthetic valve in any of the claims wherein, with left ventricular assist device (LVAD) or heart pump, to off-load the pressure across the aortic heart valve during the procedure.

52. A method of annular repair, wherein, the device is atraumatically deployed around the annulus, and the device cinched at a later date post tissue encapsulation, to cinch the annulus and thereby to mitigate regurgitation.

53. An implantable medical device for insertion in the left atrial appendage of a patient comprising: a. a frame with high compliance placed behind the annulus; and b. a cover configured to cover at least a portion of the frame to prevent passage of blood through the frame and to reduce exposure of bare metal to circulating blood.

54. An implantable medical device for insertion in the left atrial appendage of a patient according to any of the claims wherein, a component such as a sponge, foam, beads, fabric , balloon, or artificial tissue 52, used as a spacer to fill the cavity formed by the closure of the LAA.

55. An implantable medical device for insertion in the left atrial appendage of a patient, as described in any of the preceding claims, wherein the device comprises an added component selected from the group consisting of a defibrillator, a stimulator, a sensor, a transducer, a drug delivery system, a patient monitoring system, or a remotely operatable smart device, the aforementioned device being capable of both wired and wireless operation.

56. An implantable medical device for insertion in the left atrial appendage of a patient comprising a one-way valve allowing fluid into the cavity sealed at the distal end of the left atrial appendage.

57. A method of implanting a medical device for insertion in the left atrial appendage according to any of the claims, with an additional step comprising of: the LAA being flooded with saline for visualization with a camera; and or, and a temporary seal closing off area of implantation from blood flow and being flooded with saline for visualization and to check for leaks.

58. An occlusion device/method that is implanted inside the LAA (behind the

Ostia/ Annulus), configured to maximize the preservation of the LAA function, while minimizing the risk of thrombus formation.

59. The method of implanting an occlusion device inside the LAA (behind the

Ostia/ Annulus), configured to maximize the preservation of the LAA function, while minimizing the risk of thrombus formation.

60. The method in any of the claims wherein, flow dynamics, flow simulation, finite element analysis, and or artificial intelligence, is evaluated to determine the correct depth and location of the device implantation.

61. The method in any of the claims wherein, software simulation (fluid dynamics, structural analysis, and or artificial intelligence is evaluated to determine the correct depth, location, size, and or shape of the device is evaluated or determined prior to, during, and or post procedure.

62. The method in any of the claims wherein, optical, visual, echo, flouro, ICE guidance is used for implantation and to determine the correct depth, location, size, shape of the device is evaluation prior, during, and post procedure.

63. The method in any of the claims wherein, some or all of the LAA is isolated from blood supply, flushed with saline, and the LAA is visually inspected to determine the correct implantation depth, location and device size, shape of the evaluated prior, during, and post procedure.

64. The method in any of the claims wherein, the occlusion device is a single body/segment (for example the watchman device) comprising of stent, sponge, gel, saline, air, biodegradable, bioabsorbable, metallic, polymeric, organic, inorganic, elastic, plastic, super-elastic, shape-memory, balloon, bellow, diaphragm, porous structure, cone, umbrella structure, disc, 3d printed, compliant, semi-compliant, check valve, two-way valve, non-compliant, covered, coated, bare, or any combination of thereof.

65. The method in any of the claims wherein, the left atrial occlusion device comprises of 2 or more bodies/segments (for example the Abbott amulet device) comprising of stent, sponge, gel, saline, air, biodegradable, bioabsorbable, metallic, polymeric, organic, inorganic, elastic, plastic, super-elastic, shape memory, balloon, bellow, diaphragm, porous structure, cone, umbrella structure, disc, 3d printed, compliant, semi-compliant, check valve, two-way valve, non-compliant, covered, coated, bare, or any combination of thereof.

66. A left atrial appendage (LAA) device wherein the device size, shape, orientation, and the depth of implantation are determined using software analysis, including but not limited to finite element analysis (FEA), fluid flow dynamics, Dasi Simulations, and FE-Ops, said software analysis configured to maximize LAA functionality and minimize the risk of complications selected from the group consisting of thromboembolism, heart arrhythmia, perivalvular leaks, and tissue trauma.

67. A method of selecting and preplanning implantation of an LAA device, wherein, a combination of FEA, artificial intelligence, and or fluid flow dynamics will be used to determine the size, shape, features, depth of placement, and performing the procedure, to maximize LAA functionality and or minimize the risk of thromboembolism, heart arrythmia, perivalvular leaks, and or tissue trauma.

68. A device or a method for occluding the left atrial appendage (LAA), as referenced in any of the preceding claims, wherein said device or method is inspired by, but not limited to, the designs of occlusion devices such as Watchman and Amulet, configured for complete occlusion of the LAA at the ostia, and further configured to be positioned distally to the LAA ostia inside the LAA, the said method or device configured to maximize LAA functionality and minimize the risk of complications selected from the group consisting of thromboembolism, heart arrhythmia, perivalvular leaks, and tissue trauma.

69. A method or device, as described in any of the preceding claims, comprising an occlusion device, wherein the occlusion device includes one or more components selected from the group consisting of gels, sponges, pumps, sensors, transducers, and a drug delivery system, said components being located inside the occlusion device or in the distal left atrial appendage (LAA) pocket of the LAA device, or externally in locations selected from the group consisting of the atria, ventricles, or outside the LAA.

70. A method or device, as referenced in any of the preceding claims, comprising an occlusion device equipped with one or more components selected from the group consisting of bellows, discs, and compliant barriers, or any combination thereof, wherein the said components are configured to maximize or preserve the function of the left atrial appendage (LAA), while concurrently mitigating thrombus formation.

71. An embolic protection device comprising of a sealing ring, a flexible, bendable and or foldable filter, and a catheter, wherein; a. a sealing ring is expandable to seal against the blood vessel lumen, b. a filter is attached to the sealing ring and the distal segment of the catheter, c. a catheter allowing access to a device delivery system, d. a filter allowing for relative movement between the catheter and the ring, without compromising the seal of the ring or ability to capture the emboli, and e. a sealing ring that can be cinched or closed to trap the emboli and retrieve the system along with the emboli out of the body.

72. The embolic filter of any combination of claims wherein, there are 1 or more sealing rings, and 1 or more filters in between each of the rings, to allow for simultaneous or sequential expansion or cinching of the rings, and to trap and be retrieve or remove the emboli along with the catheter.

73. The embolic filter of any combination of claims wherein, the catheter is proximal or advanced distal to one or more sealing rings, to allow for implant passage, without compromising the seal.

74. The embolic filter of any combination of claims that is modified to be used in carotid, central and or peripheral arteries or veins.

75. An embolic filter, as described in any of the preceding claims, and as further described in the detailed description and as illustrated in the figures of the present disclsoure.

76. An embolic protection device comprising: a catheter having a proximal and distal sealing features with a shaft extending through and, a filter body at the distal opening of the shaft with one or more seals on the artery.

77. The embolic protection device any combination of claims wherein the filter material comprises of a flexible mesh such as a porous polymeric membrane supported by a metal skeleton, nitinol mesh, or multiple pores of same or different sizes.

78. The embolic protection device any combination of claims wherein, the filter material is supported by a wire or shape memory stent element.

79. The embolic protection device of any combination of claims wherein, a separate lumen is added to deliver a blood clotting agent or anti-clotting agent such as heparin.

80. The embolic protection device of any combination of claims, further comprising a suction device to remove debris in real time with or without visual/optical guidance.

81. The embolic protection device having multiple seals, wherein, each seal is cinched sequentially to reduce risk of losing debris and removing device.

82. The embolic protection device having multiple sealing points with the vessel wall, and having with filters in between the seals, and the filter has shape memory or a coil of lower diameter, to limit contact with the vessel wall, to mitigate trauma of embolic shower.

83. A method for embolic protection in the aortic arc comprising the steps of: providing a device comprising a proximal and distal sealing features with a shaft extending through and a filter body at the distal opening of the shaft with one or more seals on the artery, a filter comprising of a flexible mesh to trap embolic debris, a guidewire to advance the device into the aortic arch using a dilator, deploying the filter where the distal end of the filter is between the aortic valve and the brachiocephalic artery (ascending aorta), and the filter is restrained by one or more radially expanding seals.

84. The embolic protection device/method of any of the claims wherein, the proximal most seal moves past the middle and distal most seal to move the filter catheter shaft closer to the implantation site.

85. The embolic protection device/method of any of the claims wherein, the folds created by the seals moving past each other is used to catch embolic debris if blood is flowing in the opposite direction.

86. The embolic protection device device/method of any of the claims wherein, an expandable z stent is used near the distal opening to create a seal.

87. The embolic protection device of all claims wherein, the stent is cylindrical, like a cone, or like a windsock shape, and is housed in a sheath.

88. The embolic protection device in any of the preceding claims, wherein the filter catheter including the sheath is steerable.

89. An embolic protection device as in any of the figures.

90. An embolic protection device of FIG. 2 IB, comprising of an expandable seal 310, conical filter 300, and a catheter shaft 314, wherein, the conical filter limits unnecessary contact with the aortic wall.

91. An embolic protection method, as shown in FIGS. 22A to 26C, comprising the steps of: a. introducing a guidewire to the desired site, b. advancing the embolic filter catheter 314 over said guidewire, c. deploying the filter by pushing the dilator 320 out of the catheter, d. creating a seal at the distal end of the filter via an expandable ring 310, such that the seal is maintained despite relative movement of the catheter 314, e. removing the dilator 320 to create space for the insertion of a delivery device catheter 316, f. performing a procedure with said delivery device, wherein any debris released is captured by the filter, g. removing the delivery device catheter 316, h. cinching the ring 310 to contain all the debris safely, and i. removing the embolic filter catheter from the patient

92. A catheter wherein an ultrasound imaging probe that can be assembled inside the body, to increase the total area of transducer array.

93. A catheter which uses magnets, sutures, nitinol shape set, and or cables to reversibly assemble the transducers outside of the catheter.

94. A catheter housing ultrasound imaging probes that are part outside and part inside the catheter.

95. A procedure using two or more catheters to create improved imaging (both acting as emitters, receivers, in-sync, out-of-sync, sequentially or in simultaneously, in pulse or continuous mode or any combination thereof.

96. An ultrasound imaging probe imaging in transmission, reflection, backscatter, or emittance mode. Note: emittance happens when ultrasound is created by means outside of the probes, for example, by cavitation of bubbles.

97. An ultrasound imaging probe imaging in harmonic, subharmonic, and ultraharmonic modes.

98. An ultrasound imaging probe, as described in any of the preceding claims, configured to perform imaging at a set of frequencies which are multiples or fractional multiples of the emitted frequency, wherein the set of multiples includes, but is not limited to, lx, 2x, 3x, and the set of fractional multiples includes, but is not limited to, 0.5x, 0.25x, 0.125x, and the set of non-integer multiples includes, but is not limited to, 1.5x, 2.5x, 3.5x.

99. An ultrasound imaging probe, as described in any of the preceding claims, configured to operate in a non-linear ultrasonic imaging mode.

100. A catheter wherein sutures or wires are used to reversibly assemble more than one probe, wherein, the dimension of the assembled probe is much larger than the diameter of the catheter.

101. A catheter comprising a train of probes, with flexible joints inside the catheter, to allow for catheter flexibility, yet allow for increased area

102. A Delivery catheter comprising of an extension spring and torque coil, configured to resist high compressive forces, while allowing for enhanced flexibility.

103. A delivery catheter of any combination of claims, for use in structural heart, GI, vascular, or robotic applications.

104. A delivery catheter of any combination of claims, wherein, the distal portion is configured to extend straight, despite experiences tortuous curves.

105. A delivery catheter of any combination of claims, wherein, the delivery catheter comprises of multilumen shaft or multiple single lumen shafts.

106. A delivery catheter of any combination of claims, wherein, shafts are made of metal, plastic, glass, ceramic, organic, inorganic, coated, uncoated, lubricious, antimicrobial, PI, PEBAX, Nylon, nitinol, or any biocompatible material or their combination.

107. The delivery catheter of any combination of claims that can be configured to have a bend radius range of 0.1mm to 10,000mm, and in between, preferably about 9mm radius in the distal segments and about 42mm radius in the proximal segments.

108. The delivery catheter of any combination of claims that can be configured to have a compressive resistance in the range of 0.1 Ibf to 10,000 Ibf and in between, preferably 6 Ibf force resulting foreshortening in the range of 10mm to 0.0001mm, preferably -O. lmm.

109. The delivery catheter of any combination of claims that can be configured to have a distal flexible segment of length between 5mm to 500mm with compressive resistance in the range of 0.1 Ibf to 10,000 Ibf and in between, resulting foreshortening in the range of 10mm to 0.0001mm, preferably 6 Ibf force, over a length of 165mm causing a foreshortening of <0.5 mm.

110. The delivery catheter of any combination of claims that can be configured to have a proximal flexible segment of length between 5mm to 500mm with compressive resistance in the range of 0.1 Ibf to 10,000 Ibf and in between, resulting foreshortening in the range of 10mm to 0.0001mm, preferably 6 Ibf force, over a length of 760mm causing a foreshortening of <1.5 mm.

111. The delivery catheter of any combination of claims having an outer diameter (OD) in the range of 0.5mm to 50mm, preferably 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, or 15mm or any combination in between.

112. A delivery catheter of any combination of claims to treat mitral valve, tricuspid valve, pulmonary valve, aortic valve, LAA, blood vessels, organs, tissues, or GI tract.

113. A delivery catheter of any combination of claims that comprised of a chamber/segment that can move in a lumen or surface using peristaltic motion with bristles or without bristles (using friction), like an earthworm.

114. A delivery catheter of any combination of claims comprising of a chamber that can elongate, rotate, contract, curve, bend, move, push, pull.

115. A chamber or multiple chamber that can be used to remotely treat or diagnose.

116. A delivery catheter chamber that can be used in-vivo, ex-vivo, in-vitro, on benchtop, inside other machines, devices, or robots.

117. Any combination of the configurations and ideas described in this application, including with obvious modifications known to POSA in the spirit of this application.

118. Any combination of the ideas disclosed, wherein, the catheter shaft comprises of any one or all or any combination of a piston, balloon, pull wire, nitinol motor, gears, cams, or sensors that are placed outside, inside, or in the wall of the shaft, configured to elongate, rotate, shorten, pull, push, distend, approximate, tissue, manually, remotely, robotically, or using programs or Al.

119. The method of curving, shortening, and lengthening the catheter by actuating both positive and negative curving forces.

120. The method of rotating the catheter by using helical pattern of pull wires.

121. The method of maximizing isolation of segments in a multi segmented steerable catheter by using mechanical advantage (pully system) in the pull wires.

122. A delivery catheter device or method described in the specification and or shown in any of the figures.

123. A device for treating a native valve annulus, the device comprising: a. a plurality of arms, each having a proximal portion and a distal portion, wherein the arms are configured to move independently of one another; b. a coupler coupled to the arms and configured to move relative to the arms; and a plurality of anchors that are configured to promote tissue encapsulation, each carried by the distal portion of one of the arms and configured to engage tissue at or proximate the annulus; c. and cinch-band coupled to the anchors; wherein, when the device is in a deployed configuration such that the arms extend axially and radially away from the coupler, and the cinch band is configured to initially allow for the adequate time for tissue encapsulation of the anchors.

124. A device of any of the claims wherein, the coupler is configured to translate and/or rotate relative to the arms.

125. A device of any of the claims wherein, the arms are configured to translate and/or rotate independently of one another, with or without a spring bias.

126. A device of any of the claims wherein, each of the arms includes one or more locking elements, and wherein movement of the coupler relative to the arms causes the coupler to engage at least some of the locking elements on at least some of the arms, thereby fixing an axial position of each of the arms relative to the other arms and/or the coupler.

127. A device of any of the claims wherein, when the arms are in a deployed configuration, movement of the coupler relative to the arms decreases an angle between adjacent arms.

128. A device of any of the claims wherein, the plurality of arms comprises at least three arms.

129. A device of any of the claims wherein, each of the anchors is detachably coupled to one of the arms such that, upon completion of treatment, the coupler and arms are removed from the patient while only the anchors are left implanted at the annulus.

130. A device of any of the claims wherein, each of the anchors is attached to a single arm.

131. A device of any of the claims, further comprising a suture coupled to the anchors.

132. A device of any of the claims wherein, wherein the valve annulus is a cardiac valve annulus, and wherein the device is configured to be percutaneously delivered proximate to and above the annulus such that the anchors are implanted in the annular cardiac tissue just above the plane of the valve orifice.

133. A device for treating a native valve annulus, the device comprising: d. a plurality of arms, each having a proximal portion and a distal portion; e. a coupler coupled to the arms and configured to move relative to the arms, wherein each of the arms has a first length proximal to the coupler and a second length distal to the coupler, f. and wherein the distal portions of each of the arms are not coupled to another one of the arms such that the second lengths of the arms are cantilevered from the coupler; g. and a plurality of anchors that are configured to promote tissue encapsulation, each carried by the distal portion of one of the arms and configured to engage tissue at or proximate the annulus, wherein, when the device is in a deployed configuration such that the second lengths of the arms extend axially and radially away from the coupler, movement of the coupler relative to the arms decreases a circumferential distance between at least some of the anchors.

134. A device of any of the claims wherein, the arms are configured to translate and/or rotate independently of one another.

135. A device of any of the claims wherein, the coupler is configured to translate and/or rotate relative to the arms.

136. A device of any of the claims wherein, each of the arms includes one or more locking elements, and wherein movement of the coupler relative to the arms causes the coupler to engage at least some of the locking elements on at least some of the arms, thereby fixing an axial position of each of the arms relative to the other arms and/or the coupler.

137. A device of any of the claims wherein, when the arms are in a deployed configuration, movement of the coupler relative to the arms decreases an angle between adjacent arms.

138. A device of any of the claims wherein, the plurality of arms comprises at least three arms.

139. A device of any of the claims wherein, each of the anchors is detachably coupled to one of the arms such that, upon completion of treatment, the coupler and arms are removed from the patient while the anchors are left implanted at the annulus.

140. A device of any of the claims wherein, the movement of the coupler relative to the arms decreases a circumferential distance between at least some of the anchors.

141. A device of any of the claims wherein, the movement of the coupler relative to the arms increases a circumferential distance between at least some of the anchors.

142. A device of any of the claims wherein, the cinch band can be cinched (or expanded) over multiple time points (follow-up procedures) to progressively decrease (or increase) diameter.

143. A device of any of the claims wherein, the cinch band can be configured to be swapped out to cinch (or expand) over multiple time points (follow-up procedures) to progressively decrease (or increase) diameter.

144. A device of any of the claims wherein, the cinch band has biodegradable or bioabsorbable or biodisolvable that applies cinch (or expansion) forces after a set time (30 days, 60 days, 90 days, 120 days, 180 days, 270 days, 360 days, or 720 days) post implantation (or post tissue encapsulation or tissue adhesion) or the anchors or device or cinch band to progressively decrease (or increase) diameter.

145. A device of any of the claims wherein, the anchors or atraumatic anchors have fabric or braided polymeric covering, or surface coating that promotes tissue enc ap sul ati on/adhe si on .

146. A device for treating a native valve annulus, the device comprising: h. a plurality of arms, each having a proximal portion and a distal portion, wherein the arms are configured to move independently of one another; i. a coupler coupled to the arms and configured to move relative to the arms; and j . a plurality of anchors, each carried by the distal portion of one of the arms and configured to engage tissue at or proximate the annulus, a delayed response suture or stent feature that interact with one or more anchors, wherein, when the device is in a deployed configuration such that the arms extend axially and radially away from the coupler, and optionally, movement of the coupler relative to the arms decreases a circumferential distance between at least some of the anchors, and the delayed response suture or stent feature transforms from a stretched form 1 during implantation to a cinched configuration post implantation over time.

147. A device of any of the claims wherein, the delayed time to cinch is 15 day, 30 day, 60 day, 90 days, 120 days, or up to 3 years.

148. A device of any of the claims wherein, the anchor is covered with fabric, coating, surface modification, braid, polymer, metal, etc, to enhance or promote or allow tissue encapsulation.

149. A device of any of the claims wherein, each of the anchors is detachably coupled to one of the arms such that, upon completion of treatment, the coupler and arms are removed from the patient while the anchors along with the delayed cinch suture/stent are left implanted at the annulus.

150. A leaflet repair device or any of the claims, comprising of at least one leaflet augmenting feature, that beats (or swings) along with the native leaflet, configured to prevent valve regurgitation.

151. A leaflet repair device or any of the claims, paired with an annulus engaging stent, wherein, the annulus engaging stent supports the swinging/beating leaflets.

152. A leaflet repair device or any of the claims, wherein, the leaflet augmenting feature is inflatable, expandable, compressible, steerable, bendable, and/or orientable.

153. A leaflet repair device or any of the claims, wherein, the annulus engaging feature auto cinches or is manually cinchable, at a later time post procedure, after sufficient time has passed to allow for tissue encapsulation.

154. A leaflet repair device or any of the claims, wherein, the leaflet augmenting feature auto configures or is manually configurable at a later time post procedure (after sufficient time has passed to allow for tissue encapsulation), to prevent valve regurgitation.

155. A prosthetic valve of any combination of the claims comprising of an annular stent, a leaflet augmentation feature, wherein, the leaflet augmentation feature beats/swings open and close, configured to prevent regurgitation when closed and configured to allow for maximum opening of the orifice.

156. A prosthetic valve of any combination of the claims wherein, the prosthetic leaflets are at the level and below the prosthetic valve anulus, similar to native valve leaflets of an aortic valve. Optionally, the prosthetic leaflets can be above the prosthetic valve anulus. Optionally, the prosthetic leaflets are attached to the prosthetic value anulus only, mimicking native valves that are attached only to the native anulus. Optionally, the leaflets are within the prosthetic anulus and protrude out of the prosthetic anulus.

157. A prosthetic valve of any combination of the claims wherein, the prosthetic valve stent/anulus height is less than 15mm, 10mm, 7mm, 5mm, 3mm, 1mm, or 0.1mm.

158. A prosthetic valve of any combination of the claims wherein, the prosthetic valve has actuatable grasping arms to secure the prosthetic valve using native leaflets.

159. A prosthetic valve of any combination of the claims wherein, the prosthetic valve has actuatable grasping grippers to secure the prosthetic valve using native leaflets.

160. A prosthetic valve of any combination of the claims wherein, the prosthetic valve has actuatable grasping arms and grippers to secure the prosthetic valve along both sides of the native leaflets.

161. A prosthetic valve of any combination of the claims wherein, the prosthetic valve has actuatable grasping arms/grippers to secure the prosthetic valve using native aortic anulus or wall.

162. A prosthetic valve of any combination of the claims wherein, the prosthetic valve is configured to be used with other heart valves, such as pulmonary valve, tricuspid valve, and/or mitral valve.

163. A prosthetic valve of any combination of the claims wherein, the annular stent is cinchable prior to, during, or post procedure, and there is a native leaflet augmenting/support feature that is pierced through a small hole in the native leaflet from atrial side and expanded in the ventricular side.

164. A prosthetic valve of any combination of the claims comprising of an annular support structure, leaflets attached to the annular support structure, a tissue grasping or securing feature attached to the annular support structure.

165. A prosthetic valve of any combination of the claims wherein, the prosthetic leaflets primarily are below the annular support structure.

166. A prosthetic valve of any combination of the claims wherein, the prosthetic leaflets primarily are above the annular support structure.

167. A calcium modifying device of any of the claims, comprising of an energy generator, an energy transfer feature, configured to modify ions or minerals in the body.

168. A calcium modifying device of any of the claims, wherein the energy generator is electromagnetic waveform//eddy current/magnetic field generator

169. A calcium modifying device of any of the claims, wherein the energy transfer feature comprises of at least electrodes, coils, magnets, or their combination

170. A calcium modifying device of any of the claims, that is configured to mitigate calcium deposits in the blood vessels, kidneys, and organs.

171. A calcium modifying device of any of the claims, that is configured to improve absorption of minerals by tissue and organs.

172. A calcium modifying device of any of the claims, that comprises of exemplary technologies such as i Spring ED2000, Yama CWD24, Calmat, Seal eBlaster, Eddy, to modify absorption, resorption, precipitation of minerals.

173. A calcium modifying device of any of the claims, where in the EMP is applied across any region of the body, organ, tissue, either percutaneously, or subcutaneously, over the skin, externally, internally, implanted, or wirelessly or wired.

174. A optical visualization device/method of any of the claims comprising a catheter-based balloon filled with clear liquid or gas, or saline with a camera mounted on internal tubing.

175. A catheter-based balloon comprising of a camera mounted on a steerable shaft within the balloon.

176. A catheter-based balloon comprising of shock wave generators SWG filled with clear liquid; and an internal balloon with a camera inside mounted on a steerable shaft inside the balloon.

177. A shockwave generating device/method comprising of: one or more shockwave generators, a camera 2010 housed within a gas filled balloon 2050, a steerable shaft to steer the camera 2030, a reflector/focusing balloon 1960, a clear liquid filled balloon 2015 housing the shock wave generators and camera, and reflecting balloon, wherein, the reflecting balloon 2050 is positioned around the shockwave generator to focus on the treatment site, the optical camera 2010 is used to provide optical guidance to deliver the treatment.

178. A shockwave generating device/method of any of the claims wherein, the reflecting balloon 2050, the camera 2010, and any other embodiments inside the balloon 2015 be supported via sutures, braids, changing viscosity, and or any other known means to stabilize them as necessary and required during use.

179. An optical visualization device/method of any of the claims where the balloon comprises of sealable ports through with robotic catheters interventional device catheters and steerable camera shaft and camera can be advanced outside of the balloon to perform desired intervention.

180. An optical visualization device/method of any of the claims, comprising of 1 or more collapsible, self-opening umbrella like sealers ware used to divert flow of blood and are used along side saline pumps to create a see through optical medium.

181. An optical visualization device/method of any of the claims, per any combination of figures.

182. An optical visualization device/method of any of the claims, per any combination of description in the specification.

183. An optical visualization device/method of any of the claims, per any combination of description in the specification and any combinations of figures.

184. A device, as described in this entire application, an any configuration.

185. A device, as described in any of the figures and or their combinations.

186. A device, as described in any methods and or combination of methods, described herein.

187. A method, as described in the entire application, methods, and or combination of methods, described herein.

188. A left atrial appendage occlusion device or method as disclosed in any of the preceding claims or any combination thereof