Cardiovascular devices and methods

Abstract

A prosthetic aortic valve using actuation arms and grippers for attachment to leaflets reduces device displacement and resizing issues. The prosthetic aortic valve involves resecting a lesion leaflet prior to implantation, ensuring blood flow to the coronary artery, and providing optical visualization. The valve has a replaceable leaflet and a streamlined frame. Innovative left atrial appendage devices, embolic protection devices, intracardiac echocardiography devices, and steerable catheter devices are introduced. Provided herein are non-invasive, tightenable mitral annulus repair devices, non-invasive methods for improving body calcium using electromagnetic energy, and optical visualization systems for displacing blood with clear liquid in vascular interventions.

Description

Cross-references

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 507,736, filed June 13, 2023; U.S. Provisional Patent Application No. 63 / 509,664, filed June 22, 2023; U.S. Provisional Patent Application No. 63 / 519,821, filed August 15, 2023; U.S. Provisional Patent Application No. 63 / 591,052, filed October 17, 2023; and U.S. Provisional Patent Application No. 63 / 562,978, filed March 8, 2024. This application is also a continuation-in-part of U.S. Non-Provisional Application No. 18 / 668,242, filed May 19, 2024, which claims priority to U.S. Provisional Patent Application No. 63 / 503,427, filed May 19, 2023. The entire disclosure of these patent applications is incorporated herein by reference. Background Technology

[0002] Left atrial appendage occlusion devices and methods This disclosure relates to occlusion devices, and more specifically to implantable devices designed to occlude the left atrial appendage of a patient. Additionally, this disclosure includes methods relating to the use and implantation of these occlusion devices.

[0003] Embolic protection devices and methods This disclosure relates to devices and methods for providing embolic protection in a patient's vascular system. For example, the device can be deployed in a patient's aorta to provide embolic protection to the aortic arch and downstream organs. The device can be used for acute applications (such as during cardiac surgery and interventional cardiology procedures) and for potential implantation to provide continuous chronic protection against cardioembolic emboli or emboli originating from ruptured or vulnerable aortic plaques.

[0004] Intracardiac echocardiography devices and methods This disclosure relates to intravascular ultrasound imaging, such as 1D, 2D, 3D, and 4D catheters. More specifically, this disclosure relates to an intracardiac echocardiography (ICE) catheter with an increased probe surface area to transmit ultrasound and receive echoes more clearly in intracardiac diagnostics.

[0005] Novel steerable catheter devices and methods This disclosure generally relates to medical methods, devices, and systems. More specifically, this disclosure relates to steerable catheters using drawstrings and robotic devices.

[0006] Aortic valve devices and methods This disclosure generally relates to medical methods, apparatus, and systems for treating aortic heart valves. In particular, this disclosure relates to methods, apparatus, and systems for internal vascular, percutaneous, or minimally invasive surgical treatment of body tissues, such as tissue apposition or valve repair / replacement. More specifically, this disclosure relates to methods and apparatus for the repair or replacement of aortic valves; however, as will be apparent to those skilled in the art (POSA), these novel aspects can be applied to treat pulmonary artery, mitral and tricuspid heart valves, venous valves, and other tissue structures via minimally invasive and other surgical procedures.

[0007] Mitral valve devices and methods This disclosure generally relates to medical methods, devices, and systems for treating mitral and tricuspid heart valves. In particular, this disclosure relates to methods, devices, and systems for endovascular, percutaneous, or minimally invasive surgical treatment of body tissues, such as tissue apposition or valve repair / replacement. More specifically, this disclosure relates to methods and devices for the repair or replacement of the mitral valve; however, as will be apparent to those skilled in the art (POSA), these novel aspects can be applied to treat pulmonary valves, aortic and tricuspid heart valves, venous valves, and other tissue structures via minimally invasive surgery and other procedures.

[0008] Anti-calcification vascular devices The disclosure generally relates to medical methods, devices, and systems for non-invasive, skin-based, percutaneous, endovascular, percutaneous, or minimally invasive surgical treatment of body tissues to prevent or treat calcification of the body, organs, tissues, and / or blood vessels.

[0009] Visualization of interventional procedures The disclosure generally relates to medical methods, devices, and systems for non-invasive, dermal, percutaneous, endovascular, or minimally invasive surgical treatment of body tissues to prevent, diagnose, or treat tissues via direct visualization. More particularly, this disclosure relates to methods and devices for vascular interventional procedures to provide direct visualization of blood vessels by displacing blood and / or tissue. The disclosure allows for direct visualization within and / or beyond the vascular tract by displacing blood, tissue, bone marrow, pus, and / or fluids. While exemplary embodiments and methods are taught, these novel aspects can be applied to treat vascular, cardiovascular, neurovascular, urinary, gastrointestinal, orthopedic, lung, spine, brain, heart, muscle, kidney, or any other organ and tissue structure, as will be apparent to those skilled in the art (POSA). Additionally, the disclosed methods and devices can be configured for any other application where optical visualization is obstructed by a largely opaque fluid, medium, and / or tissue. Summary of the Invention

[0010] Left atrial appendage occlusion devices and methods The novelty of this device and / or method lies in the highly compliant, non-invasive frame implanted distal to the aperture of the LAA, deeper into the LAA than the current standard of positioning (at or near the aperture). This device and / or method discloses to provide treatment and / or improvement for LAA while a) preserving at least some LAA functionality, b) implanting the device non-invasively but securely and preventing device displacement or dislodgement, c) reducing peri-LAA leakage, d) reducing leakage around and / or from the device, e) providing an anatomically compliant device that adapts to greater variations in the size and shape of the LAA, f) minimizing any adverse effects on electrical conduction pathways, g) minimizing or eliminating any trauma or encroachment to atrial space, h) alleviating clot formation around the device, i) minimizing the duration of immediate post-implantation anticoagulant therapy, j) promoting more effective endothelialization around the device, k) maximizing preservation of LAA functionality and effectively trapping any clots within, i) allowing implantation of the occlusion device under direct visual guidance, allowing indirect assessment of blood leakage by observing the presence of blood in the flushed saline, m) allowing implantation of a smart device isolated / secured by the occlusion device or implantation of a smart device in the occlusion area of ​​the LAA. Additional advantages include the option to flush the occluded portion to further alleviate clot formation and the ensuing inflammatory response and / or allow for diagnostic optical visualization of the trapped area. Other advantages include, but are not limited to, a higher level of compatibility with challenging anatomy that is incompatible with current devices requiring significant space in the left atrial space adjacent to the LAA; progressive reduction in the volume of the trapped / occluded LAA; creating safe space for implants such as defibrillators, stimulators, sensors, transducers, remotely operable, wired, and wireless smart devices; and the opportunity for significant time savings due to the use of a single implant that is less sensitive to deployment site or increases the implantation area, thus requiring less repositioning.

[0011] Embolic protection devices and methods Methods, systems, and apparatuses for filtering embolic fragments generated both during surgery and during the placement and removal of the embolic protection device itself are disclosed. One exemplary embodiment of the embolic protection device includes a filter body and a catheter shaft, allowing access to the aortic valve via the device catheter without trauma to the vessel wall, and providing systemic protection by preventing the release of emboli into aortic collateral vessels and downstream vessels.

[0012] Exemplary implementations include a large introducer or catheter sheath through which one or more secondary device delivery catheters can be passed directly to the implantation site. This eliminates the need for multiple entry points through the femoral artery, significantly reducing the risk of infection, complications, and healing and surgical time. This sheath can be guided through the aortic arch, remaining centered on the artery and thereby preventing embolic fragments from dislodging onto the arterial side. From this sheath, the embolic filter is deployed, radially dilated, creating a non-invasive seal at the distal end of the device with minimal contact with the artery, thus reducing the risk of embolus dislodgement.

[0013] Unlike common embolism protection devices, this disclosure does not deflect debris into a capturing element. Instead, it uses a filter to capture embolic debris composed of a porous mesh material, such as fabric, plastic, metal, or nitinol mesh / woven fabric / sieve. To maintain the integrity of the filter's contact with the vessel wall, the section of the filter connected to the catheter will be flexible and long enough to allow for a wide range of catheter movement. The surface area and pore size are large enough that the filter does not generate pressure loss that would otherwise cause blood to flow through vital aortic collaterals, while effectively capturing debris. For example, deflectors as in the prior art can generate such pressure loss, causing blood to bypass collaterals or flow through them at a lower velocity. The filter in this disclosure is preferably placed in the ascending aorta and may have a preferred pore size of 20-50 micrometers. Multiple tissue contact seals can be implemented together with manual or self-expanding auto-seals to reduce the risk of dislodgement.

[0014] In an exemplary embodiment, at the distal end of the filter, the filter expands to the size of the aortic diameter. An odd number of Z-shaped stents or spring wires, compression springs, coils, or balloons can be used to better expand and seal the filter.

[0015] If a large number of embolic fragments are collected, the filter can be recycled, or the fragments can be aspirated or expelled in real time using vacuum or positive blood pressure.

[0016] In an exemplary embodiment, the device has two or more seals on the distal and proximal sides of the guide / sheath catheter shaft opening, and has sufficient redundant length to allow trapped fragments and minimal free movement of the catheter shaft opening between the seals (without dislodging or affecting the seals and / or abrading / dislodging fragments from the aortic lumen wall), while being configured to allow safe capture and retrieval of fragments and / or removal / retrieval of the embolic device at the end of the procedure.

[0017] While the embodiments shown in the figures primarily illustrate aortic valve surgery, they are equally applicable to both aortic and mitral valve surgeries, as the ascending aortic arch is downstream of both the mitral and aortic valves. Similarly, these embodiments can be modified for tricuspid and pulmonary valve applications by placing the filter immediately downstream of the tricuspid and pulmonary valves. Likewise, these concepts disclosed can be readily configured by POSA for other procedures with embolism risk, such as carotid artery stenting.

[0018] Intracardiac echocardiography devices and methods Typical ICE catheters use a single transducer that fits within a 12-gauge catheter, limiting surface area. The advantage of this disclosure is the increased surface area or size of the sensor / transducer. This results in clearer and larger images of cardiac structures with increased resolution during the procedure, facilitating faster decision-making and a smoother workflow.

[0019] Typical catheter probes are flat and limited to a 90×90 degree field of view. The advantage of this disclosure is that this field of view can be increased by adding curved, angled probes or assembling and pairing multiple probes in multiple directions, thus reducing the need for rotating transducer tips, optimizing device position and orientation, and allowing the user to simultaneously capture more cardiac views at any given time. The advantage of this disclosure is the ability to perform multimodal imaging (A-mode, B-mode, M-mode, C-mode, Doppler, 3D, 4D, elastic modulus imaging, linear mode, curve mode, phase array, transmission mode, reflection mode, backscatter mode, harmonic mode, subharmonic mode, superharmonic mode, continuous mode, pulsed mode, or combinations thereof).

[0020] An advantage of this disclosure is that two or more ICE catheters can be combined to provide improved image quality and / or size.

[0021] Novel steerable catheter devices and methods The novel disclosure in this application allows for complete control of the catheter by utilizing the functionality of both the positive and negative sides of the drawstring. The disclosure allows for new movements, such as achieving axial length adjustment, bending with greater stability via differential pulling of the drawstring, and superior control through the application of tension inward and in opposite directions. The disclosure utilizes the mechanical advantages of a pulley system to achieve better isolation of segmented bending and / or to apply higher steerable forces in specific segments of the catheter while minimizing forces in other segments.

[0022] Another advantage of this disclosure is the ability to facilitate catheter rotation using a helical pattern, either in the presence of a bend or in combination with a bend. In some embodiments, the disclosure can be combined with structural reinforcements along the length of the catheter to configure selective segmentation forces, while all segments use the same drawstring.

[0023] In some implementations, Nitinol motors, pneumatic or fluid mechanisms are used to achieve the steerability of individual segments or to adjust curvature, modify length, and rotate. Additionally, the incorporation of motors and smart sensors enables robot control, employing proven industrial robot technologies applicable across both medical and non-medical fields to improve accuracy and functionality.

[0024] Aortic valve devices Most prosthetic devices used for valve replacement (such as those for the aortic valve) rely on compression against the annulus or wall, requiring high stiffness or considerable expansion force. Additionally, these devices often need to be longer than necessary to prevent displacement or misplacement. An advantage of this disclosure is its ability to grasp the leaflets, effectively reducing the risk of device displacement and allowing for smaller device sizes for device fixation. Furthermore, the disclosure teaches methods and implementations that allow for the cutting of diseased native and / or prosthetic leaflets (including complete removal of the prosthetic valve). The disclosure also teaches modular or insertable / replaceable prosthetic leaflets within the valve. The disclosure also teaches methods for achieving blood flow to the coronary arteries during valve replacement surgery, particularly in cases of cutting / removing diseased leaflets. The disclosure also teaches methods and implementations for optical visualization during valve replacement surgery.

[0025] Conventional prosthetic mechanical valves typically have exposed bare metal that is not intended to be covered by tissue, thus requiring continuous use of anticoagulants to prevent clots. A key advantage of this disclosure is that the exposed bare metal surface in contact with blood flow may be minimal or nonexistent. Furthermore, the disclosure teaches mechanical valves with minimal or no moving metal components. Additionally, the disclosure teaches methods and implementations for catheter delivery and implantation.

[0026] While the exemplary embodiments in this disclosure focus primarily on the aortic valve, the design concepts can be extended to include all heart valves (pulmonary valve, mitral valve, tricuspid valve, aortic valve), pulmonary valve, GI valve, and other applications that are obvious to those skilled in the art.

[0027] Mitral valve devices and methods The exemplary embodiments described herein disclose methods and apparatus for tightening valve annulus acutely (during surgery) and chronically (postoperatively) using non-invasive anchors.

[0028] The publication also discloses a method and apparatus for enhancing prosthetic leaflets, wherein the leaflet enhancer is attached to the original leaflet and pulsates (or rotates) together with the original leaflet to better maintain / match the physiological flow pattern.

[0029] The publication also discloses a method and apparatus for combining a non-invasive annular device and a pulsating / rotating leaflet enhancement device.

[0030] Anti-calcification vascular devices and methods Similar to exemplary industrial water treatment devices (such as iSpringED2000, Yarna CWD24, Yarna CWD48, Eddy, and Calmat) that improve the properties of calcium and other mineral ions in plumbing systems of home / office / commercial buildings by applying electromagnetic, electrical, magnetic, and / or light techniques to reduce calcium deposition in pipes, the disclosure teaches the application of techniques to improve calcium and other mineral ions flowing in the body to selectively or as a whole improve and / or prevent calcium deposition in blood vessels, heart valve leaflets, tissues, or organs. In some embodiments, the disclosure can be used to increase mineral deposition (e.g., increase calcium deposition in bones) to treat, for example, osteoporosis, and is not limited to this example, as understood by POSA. As understood by POSA, these techniques can be used to remove or prevent calcium deposition-related diseases such as atherosclerosis noninvasively, interventionally, minimally invasively, surgically, or in any combination thereof.

[0031] Hypothesis 1: By applying similar electromagnetic pulses to the human body, it may be possible to alleviate or reverse calcified veins and arteries. If this hypothesis holds true, it could treat millions of patients suffering from vascular and valvular diseases.

[0032] Hypothesis 2: By keeping calcium and other minerals in the blood rather than depositing them in the lumen of blood vessels, more of these minerals can be used for body organs such as bones and heart / muscles, thus potentially alleviating osteoporosis and muscular diseases caused by calcium deficiency.

[0033] This disclosure applies the aforementioned industrial solutions to improve calcium mineral content in water supplies, thereby regulating calcium absorption in the body and descaling blood vessels and heart valves.

[0034] The advantage of this disclosure is that it can regulate calcium in the body non-invasively and without drugs.

[0035] The advantage of this disclosure is that it can more safely destroy calcified plaques by using directional or focused acoustic / ultrasonic shocks.

[0036] Visualization of vascular interventional procedures Blood is inherently opaque and therefore lacks optical visualization in vascular interventional procedures. CT scans, MRI, ultrasound imaging, and fluoroscopy are available, but the availability of real-time optical visualization would significantly benefit the procedure. Therefore, visualization of blood vessels or heart valves is required, similar to that used in open or invasive surgery.

[0037] The advantage of this disclosure lies in its ability to visualize blood vessel and heart structures using a common optical camera. This is achieved by locally displacing the blood and replacing it with a clear fluid. For example, the clear fluid could be air or saline solution.

[0038] The advantage of this disclosure is that it allows for optical visualization using techniques such as balloons, cones, and irrigation procedures.

[0039] Moreover, optical visualization is made available in a wide range of interventional procedures where visualization is crucial or desirable. For example, optical visualization can be beneficial during procedures such as plaque destruction using stents, angioplasty, arterial resection, and valve repair. Attached Figure Description

[0040] Figures 1-20 The illustration shows a left atrial appendage closure device and method according to some embodiments; Figures 21A-28D The illustrations show embolism protection devices and methods according to some embodiments; Figures 29A-39D The illustrations show an ICE apparatus and method according to some embodiments; Figures 40-48F The illustration shows a novel steerable conduit device and method according to some embodiments; Figures 49A-79D The illustrations depict aortic valve devices and methods according to some embodiments; and Figures 80A-97 The illustration shows a mitral valve annulus repair according to some implementation methods. Detailed Implementation

[0041] Left atrial appendage occlusion devices and methods The left atrial appendage (LAA), or left auricle, is a muscular sac or windward pouch-like structure that protrudes from the left atrium of the heart. During atrial fibrillation (AF), mitral valve disease, or other cardiac conditions or pathological events related to cardioversion, the contractility of the LAA is impaired, and blood clots may form within it. These blood clots pose a risk of detaching and becoming embolic, which can lead to significant risks associated with stroke or other ischemic damage to organs of the body.

[0042] LAA occlusion is an alternative treatment strategy to coagulants or anticoagulants such as coumarin derivatives, heparin-based drugs, small molecule inhibitors, antithrombin-based drugs, and / or similar classes. Due to underlying tissue factors associated with previous bleeding, non-compliance, and / or pregnancy, not all patients are suitable candidates for this type of coagulant, thus necessitating other treatment options such as the use of occlusion devices.

[0043] The current state of existing technologies and methods largely involves completely blocking LAAs. The thought process revolves around the idea that LAAs are redundant and have no functionality or limited functionality.

[0044] Most current devices used for LAA plugging generally include expandable nitinol frames, etc. Some of these devices are, for example, those in U.S. Patent 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; 7,41 0,482; 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 U.S. Application No. 2 003 / 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 / 031 3270; 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 numbers EP1651117 and EP3892240; and international application numbers WO13 / 028579; WO13 / 109309; WO13 / 152327;WO 2022 / 133088; WO 2023 / 062093; WO 2023 / 086285; WO2023 / 086329; US20230149072A1; WO2023086329A1; WO2023086285A1; US20230071725A1; US20220370056A1; US2 0220313271A1; US20220313270A1; US11432809B2; US20220218356A1; US11382635B2; US11331104B2; US11331103B2; US11648013 B2; US20230146949A1; US20230145262A1; US20230130379A1; US20230129101A1; WO2023062093A1; US20230084301A1; US2023007 9900A1; US11589873B2; EP3892240B1; US20230052812A1; EP4129210A1; US20230032647A1; US20230031497A1; and US11419611B2. Although the use of this device results in fewer hemorrhagic strokes compared to the use of anticoagulants alone, it still has known drawbacks and limitations, such as, but not limited to, pericardial effusion, partial LAA occlusion, device dislodgement, blood clotting on the device, anatomical incompatibility, and / or combinations thereof. Furthermore, the aforementioned LAA occlusion devices and related methods focus only short-sightedly on thrombus relief, and the LAA is generally considered to have limited functionality or be a redundant organ, or become redundant once its contractility is impaired.

[0045] This is a serious misconception because the left atrium (LAA) performs a vital function similar to a buffer (like a capacitor). Furthermore, because the left atrium and left ventricle are two separate pumps in series, operating at different pressures and slightly out of sequence (typically, atrial contraction initiates before ventricular contraction). Further, their ejection and filling rates vary throughout the cardiac cycle. The LAA performs a crucial function in compensating for changes / mismatches / surges in blood flow / volume between the atria and ventricles.

[0046] Therefore, there is a need in the field for improved occlusion devices and methods that at least partially retain the important functionality of the LAA while minimizing the aforementioned risks such as thromboembolism, device displacement, fluid accumulation, and leakage.

[0047] Embolic protection devices and methods During various endovascular procedures, when a catheter is guided through a patient's aortic arch, embolic fragments can inadvertently become dislodged, causing mild to severe cardiovascular complications, leading to stroke, organ failure, or even death. Typically, embolic protection devices capture embolic fragments or redirect them to lower-risk areas. These devices usually consist of stents or braided nets with a large contact area with the aortic wall, and in some implementations, cover almost the entire aortic arch and a significant portion of the descending aorta. This introduces the risk of releasing a large number of embolic fragments during embolic protection device removal / retrieval when the device becomes dislodged / dragged across the aorta.

[0048] Therefore, there is a need for improved embolization protection devices and methods that minimize the risk of embolic fragmentation not only during the procedure but also during the removal / recovery of the embolization protection device itself. Similar solutions are needed in other central and peripheral endovascular procedures, such as, but not limited to, these examples, carotid artery stenting, and aneurysm treatment devices.

[0049] Intracardiac echocardiography devices and methods Current 4D intracardiac echocardiography (ICE) catheters produce reasonably high-quality 3D moving images. However, to be small enough to be inserted into the heart chambers without general anesthesia, for example via a jugular or femoral vein or arterial approach, catheter size is limited by vessel size, which in turn limits the size and surface area of ​​the transducer or probe. This limits the quality and size of the images from within the heart. Therefore, ICE catheter images are far inferior to those from TEE (transesophageal echocardiography) catheters, which have much larger transducer / probe sizes or surface areas.

[0050] Therefore, there is a need for ways to introduce probes (transducers, transmitters, sensors, arrays, or combinations) with larger surface areas or to assemble more than one smaller probe to create a superarray probe or imaging method that collectively provides a larger surface area or field of view to improve overall imaging quality, field of view, multiple views, diagnosis, and better support treatment.

[0051] Novel steerable catheter devices and methods Current steerable catheters primarily rely on simple pull-wire manipulation for steering. However, this approach becomes suboptimal as catheter size and complexity increase, leading to a) increased pull-wire force and b) areas / segments requiring pull force for control / guidance of the catheter. This creates two main problems: First, increasing pull force requires increasing the pull-wire diameter or the number of pull-wire strands, subsequently increasing the pull-wire lumen size, and ultimately increasing the catheter's outer diameter (OD) for a given lumen size. Second, in multi-segment catheters, selectively steering the distal segment causes tension to be transmitted along all its proximal segments, inadvertently causing them to also bend or steer. Attempts to counteract this involve reinforcing, stiffening, or steering the proximal segments differently, but even with laser-cut tubing, optimal results are not achieved—especially when multiple proximal and distal segments are steered in the same direction. Therefore, there is an urgent need for: a) improved steering isolation between segments, b) a method to deliver higher forces to selected segments while minimizing their impact / force on proximal segments, and c) a method to increase tension in selected segments without escalating tension in proximal (or distal) segments, while all segments simultaneously reduce or maintain the size of the tension line.

[0052] Aortic valve devices and methods Trauma-free aortic valve Most prosthetic devices used for heart valve replacement (such as those designed for the aortic valve) are held in place by compression against the valve annulus or wall to mitigate paravalvular leakage and device displacement. To achieve this, these devices require high rigidity or the application of significant expansion forces, often necessitating larger dimensions in both length and diameter to minimize the risk of displacement. However, increases in the size, rigidity, and length of these devices can negatively impact the interaction with surrounding anatomy and blood, potentially leading to problems such as increased stress points, deformation, restricted blood flow (ischemia), tissue death (necrosis), and other complications.

[0053] Actuatable arms for secure positioning Alternative devices like Jenavalve engage with leaflets primarily for positioning purposes. Other examples, such as those in U.S. Patent 10,925,724 B2, engage with leaflets; however, in order to engage or disengage with the leaflets, manipulation of the prosthetic valve is required. That is, in all of these devices, the valve capturing element lacks the ability to be independently actuated (e.g., without disturbing the body of the prosthetic valve) to firmly grasp or not grasp the valve.

[0054] Spacers and / or flaps: In some cases, regurgitation exists in the aortic valve because of a gap between the valves. This can occur due to sclerosis, tearing, and other medical conditions. In these cases, a simple spacer or flap device that can effectively and functionally seal the regurgitation is needed. This solution / treatment can be temporary, semi-permanent, or permanent. Temporary or semi-permanent solutions are often a transition to more permanent solutions such as total valve replacement.

[0055] Leaflet replacement The typical lifespan of most prosthetic tissue valves is 5 to 15 years. Current advanced transcatheter procedures involve deploying a new prosthetic valve within a 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 when inserting a second valve. Therefore, it is necessary to trim the leaflets of the failed prosthetic valve or remove it entirely to create sufficient space for the effective operation of the new prosthetic valve.

[0056] Leaflet shape and attachment The native leaflets of the aortic valve are attached to the base of the annulus and located 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 located above the annulus. This results in a hemodynamic flow pattern and stress that differs from the natural physiological flow pattern. Therefore, there is a need to develop prosthetic valves that more closely resemble the structure of the native leaflets to better mimic the native flow pattern.

[0057] Flow management The aortic valve is a vital, high-pressure heart valve, and any procedure performed on it can disrupt downstream flow, including flow to the heart itself. Therefore, methods and devices are needed to maintain flow and pressure (including providing thrombus protection) during and / or after surgery.

[0058] Leaflet reinforcement Current devices primarily focus on valve replacement. However, methods and devices for valve repair via leaflet enhancement prior to future valve replacement have been disclosed.

[0059] Mechanical valve These mechanical valves have a long lifespan of over 20 years, but require continuous use of anticoagulants. Therefore, there is an urgent need to improve the blood compatibility of these valves. Additionally, there is a need for transcatheter placement of mechanical valves to further improve their accessibility and application in medical procedures.

[0060] Mitral valve devices and methods Trauma-free annulus devices and methodsThe current state of transcatheter treatment for mitral regurgitation is edge-to-edge repair. However, improved outcomes are possible with feasible transcatheter annulus reduction methods. Current solutions for annulus reduction involve inserting multiple screws / anchors into the annulus, which not only increases the risk of injury but also makes the procedure overly complex. Moreover, annulus reduction during the procedure can lead to tearing or tissue trauma from the screws / anchors, escalating the risk of arrhythmias and rendering it an impractical solution. Therefore, a non-invasive transcatheter annulus repair device is necessary. Additionally, it would be preferable if such a device could be adjusted or automatically tightened post-implantation by encouraging reverse remodeling of the heart to optimize its effectiveness.

[0061] Leaflet reinforcement devices and methods Current leaflet enhancement technologies are either ventricular-side supporting leaflets, as in US20230040083A1, or atrium-side supporting leaflets, as in EP 3912595B1. In these current devices, the prosthetic leaflet enhancer does not rotate or pulsate along with the native leaflet. This can alter the native flow pattern. Therefore, there is a need for a prosthetic leaflet enhancement device that rotates and pulsates along with the native leaflet to achieve the native flow pattern.

[0062] Anti-calcification vascular devices and methods Coronary atherosclerosis, aortic valve calcification, kidney stones, and gallstones are just a few examples of calcium deposits that contribute to unhealthy conditions and diseases in the body. On the other hand, calcium loss from bones also leads to conditions such as osteoporosis. Most interventional and invasive treatments are not without risk or are ineffective in addressing these conditions. For example, stents only treat the localized site of disease and do not prevent blockages in other blood vessels. Medical treatments are not always effective and cannot reverse atherosclerosis. Therefore, alternative treatments are needed to address these issues. Preferably, non-invasive methods that perform selective tissue or systemic treatments are preferred.

[0063] Industrial electronic salt-free systems such as iSpring ED2000, Yarna CWD24, Yarna CWD48, Eddy, Calmat, and ScaleblasterSB-Elite use capacitance, magnetism, eddy currents or electromagnetic pulses, electromagnetic shocks, and / or continuous electromagnetic energy in household / office plumbing to prevent calcium deposits, sediments, precipitates, or scale. They claim to work by altering the adhesion characteristics of scale, preventing it from depositing itself on clean surfaces inside pipes and appliances. The products do not change the water's chemical hardness (TDS), thus retaining the beneficial effects of calcium and other minerals. These products claim not only to alleviate calcium scale buildup in pipes but also to dissolve any existing scale, thus improving pipe lumen size and consequently improving flow through the pipe. Most of these technologies involve wrapping a wire around the water pipe (outer diameter) at least once, similar to a solenoid winding. Two or more such windings are typically used, with a small space between the two windings.

[0064] For example, the ED2000 website claims that it operates by wrapping two antenna cables around the main water pipe to form a coil, generating complex, frequency-modulated electromagnetic waveforms. This induces an oscillating electric field in the water, causing water molecules to agitate sufficiently to trigger the release of carbon dioxide and induce premature precipitation of calcium carbonate. This process naturally results in a slight increase in solubility, which allows the currently unsaturated water to dissolve existing scale and remove it from the water system.

[0065] In another example, Yarna CWD24 is an alternative water softener for home use that treats water with electrical pulses generated within an electronic unit and controlled by a microchip. These pulses are transmitted via our ultra-flat pulse belts, which break down crystals that would otherwise accumulate to form limescale, which can damage appliances.

[0066] In another example, the Calmat website describes a unique electro-pulse technology based on the principles of physical water treatment; it alters the crystallization process of liquid calcium, thereby causing hard scale to lose its ability to adhere. Like other systems that use magnetic fields, Calmat operates independently of water velocity. Calmat is suitable for all pipe materials.

[0067] Another method to break down calcium plaques is to use ultrasonic shockwaves. However, these shockwaves are not directional, so they require higher energy, which could lead to safety issues.

[0068] Visualization of interventional procedures In addition to echo-guided and fluoroscopic visualization, endoscopic and invasive surgical procedures offer the advantage of real-time optical visualization. For example, minimally invasive or interventional endoscopic procedures use gas or clear fluid to inflate the site, allowing visualization via an optical camera or direct visualization. However, in vascular interventions, the presence of blood inherently precludes this option of optical visualization. Therefore, most current procedures are performed under echo-guided or fluoroscopic guidance. Consequently, optical visualization needs to be implemented as an additional modality / tool ​​in catheter-based vascular interventions.

[0069] Left atrial appendage occlusion devices and methods Figure 1 This is a block diagram of a part of the heart without any implanted devices, labeled with the left atrial appendage (LAA), foramen (ORI), and left atrium (LA).

[0070] Figure 2A It is a simplified diagram of the left atrial appendage, which has the shape of a chicken wing.

[0071] Figure 2B It is a simplified diagram of the left atrial appendage, which has the shape of a wind vane.

[0072] Figure 2C This is a simplified diagram of the left auricle, which resembles a broccoli floret.

[0073] Figures 3A-3D Schematic diagrams of three different configurations of the left atrial appendage closure device are shown. Figure 3A This is an example of a device in the form of a single-structure closure device 10. Figure 3B An alternative two-part closure device 20 is shown, wherein the body 26 is connected to the two-part closure device 20 via a connector 24 to hold the proximal cover plate 22 in place. Figure 3C An alternative form of the sealing device 30 is shown, in which one or more anchors 38 are used to hold the disc 36 in place. Figure 3D Some examples of existing closure devices are shown.

[0074] Figure 4A It shows that it will be as follows Figure 3A The closure device 10 shown is placed in a prior art example of a heart block diagram where the orifice of the LAA is sealed. Figure 4B An example of a closure device 10 implanted in a schematic diagram of an LAA having a chicken wing-shaped configuration is shown.

[0075] Figure 5A It shows that Figure 3B The closure device 20 is placed in the heart diagram. Figure 5B An example of a closure device 20 embedded in a schematic diagram of a LAA with a wind-direction bag-like configuration is shown, as in a prior art example where the orifice of the LAA is sealed.

[0076] Figure 6A It shows Figure 3C The example placement of the closure device 30 in the block diagram of the heart. Figure 6B The current state of the reference art shows an example of an implanted LAA closure device 30 in a schematic diagram of an LAA with a broccoli-like configuration, wherein the LAA is intended to seal around the hole.

[0077] Figure 7A Exemplary embodiments (devices and / or methods) disclosed are shown, illustrating the positioning of the left atrial appendage closure device 10 behind the valve annulus ORI and toward the distal end of the LAA. Figure 7B An example of an LAA closure device 10 implanted in a schematic diagram of a LAA with a chicken-wing-shaped configuration is shown. This advantageously allows some of the functions of the left atrial appendage as a decompression / buffer chamber to be preserved and reduces the likelihood of dislodgement due to reduced pressure caused by cardiac contraction. Furthermore, by placing it distal to the orifice, the risk of dislodgement is significantly mitigated. Thus, compared to prior art devices, the LAA closure device can be additionally configured to have a more compliant and / or less invasive anchoring element to advantageously avoid tissue trauma. The shape of the stent can be like a cylinder, cone, cup, umbrella, or sphere, and can be placed further distal to the orifice D, depending on the physiological limitations of the LAA.

[0078] Figure 8A Exemplary embodiments (apparatus and / or methods) disclosed are shown, illustrating an LAA closure device 20 placed behind the ORI and toward the distal end of the LAA. Figure 8B An example of an LAA closure device 20 implanted in a schematic diagram of a LAA with a wind-direction bag-like configuration is shown.

[0079] Figure 9A An exemplary embodiment (apparatus and / or method) of the present disclosure is shown, illustrating an LAA closure device 30 with a single anchor 38 placed behind the valve ring ORI toward the distal end of the LAA. Figure 9B An example of an implanted LAA closure device 30 is shown in a schematic diagram of an LAA with a broccoli-shaped configuration.

[0080] Figure 10 It shows Figure 7A An exemplary embodiment additionally includes a sponge, foam, beads, fabric, balloon, or artificial tissue 52 used as a spacer to fill the cavity formed by the occlusion of the LAA.

[0081] Figure 11 It shows Figure 7BAn exemplary embodiment additionally includes a device / component 63 added within the sealed portion of the LAA. This component 63 may be a defibrillator, stimulator, sensor, transducer, drug delivery system, or a remotely operable, wired, or wireless smart device, such as a smart device for long-term patent monitoring, drug delivery, biomarkers, and / or therapeutic devices.

[0082] Figure 12 It shows Figure 11 In an exemplary embodiment, device / component 63 may optionally be embedded within component 73, wherein component 73 is a removable, replaceable, fillable, rechargeable chamber and / or pouch that may be placed within or outside device 10 and / or partially outside device 10.

[0083] Figure 13 A method for indirect visual guidance implantation of device 10 is illustrated, which involves observing the presence / leakage of blood by observing the flushed saline solution. The catheter sheath 102 used comprises a first tubing 104 for flushing saline solution into an orifice and a second tubing 108 for aspirating fluid out of the orifice. In an alternative embodiment, direct visualization can be achieved using a catheter-based camera, as known from POSA.

[0084] Figure 14 It shows Figure 13 Alternative implementations / methods, wherein sensor 63 can be used for non-visual sensing of the presence of blood or visualization of the presence of blood leakage.

[0085] Figure 15 A method for implantation implementation is shown. Figure 14 The method shown uses a temporary seal 118 to isolate the LAA from the bloodstream, so that the isolated segment can be clearly flushed with saline solution both proximal and distal to the body 10 for direct visualization (optical, ultrasound, infrared, etc.). Alternatively, a sensor (e.g., a camera) 63 can be used to allow implantation of the device under direct visualization.

[0086] Figure 16 A method for implanting a device in 14 using a temporary seal 118 is illustrated to isolate the entire LAA (including the orifice of the LAA) from blood circulation, so that the LAA can be flushed clean with saline solution to achieve direct visualization of the entire or part of the LAA using sensors (e.g., a catheter-based steerable camera). This allows for device implantation under direct visualization.

[0087] Figure 17A LAA occlusion device 130, additionally including a one-way valve, is shown. This valve allows the LAA to fill with blood pressure equal to the maximum pressure (P3) seen in the left atrium (P2). In an alternative embodiment, the one-way valve can be reversed, allowing outflow from the LAA, thereby gradually reducing the volume of the LAA and causing it to shrink in size acutely or over a prolonged period. In an alternative embodiment, device 130 includes a check valve and a pressure regulating device. In an alternative embodiment, device 130 has a resealable portion to allow needles, tubes, light, fluids, catheters, etc., to pass through the body 130.

[0088] Figure 18 An exemplary embodiment of the occlusion device 130 is shown, which includes, but is not limited to, these examples, bellows, diaphragms, springs, cones, sponges, membranes, or meshes / sieves. Optionally, a component 140 may be added to enhance buffer tank functionality, LAA functionality, or alleviate thrombosis. Component 140 may be saline solution, a balloon, gel, sponge, spring, mesh, coil, braid, fabric, or vacuum.

[0089] Figure 19 Exemplary methods for deploying currently disclosed implementations are described, which rely on user / surgeon skills and common / available imaging modalities (e.g., ultrasound and fluoroscopy).

[0090] Figure 20 An exemplary method for deploying the currently disclosed implementation is described, which is enhanced via computational finite element analysis, fluid dynamics, optical tomography, current imaging modalities, and / or artificial intelligence. Figure 19 The method described in the study aims to determine the optimal size or shape of the LAA plugging device and the placement location of the LAA plugging device to maximize the retention of LAA functionality while minimizing the risks of embolism, leakage, and device displacement.

[0091] Embolic protection devices and methods Figure 21A An example embolism protection device is shown in a schematic diagram of the aorta. The device includes a filter 300 with an expandable and sealed distal end 310 configured to seal against the aortic wall and a proximal end 312 attached to the distal end of a catheter sheath 314. The sheath 314 and filter 300 are configured to allow aortic repair or replacement devices to pass through the sheath 314 and filter 300. Furthermore, the embolism protection filter 300 is configured to allow minor movement of the catheter sheath 314 without dislodging or affecting the seal 310 or the aortic wall.

[0092] Figure 21B This is shown converted to a simpler block diagram. Figure 21AThe distal end of the device has a seal 310 that approaches and seals the aortic wall, while 312 is the proximal end of the filter attached to the catheter sheath 314, and 316 is an exemplary aortic valve replacement device that passes through the sheath 314. The filter forms a seal on the aortic wall away from the aortic collaterals, preventing damage to the aortic sidewall when the delivery device or catheter is passed through the filter catheter sheath, reducing the risk of embolic fragment dislodgement. The device delivery catheter can be accessed through the filter catheter sheath without requiring a separate opening through the femoral artery approach to perform the necessary aortic valve procedure. Any dislodged embolic fragments are then captured by the filter as blood flows toward the aortic valve, and the filtered blood is able to pass through to the aortic branches or other body sites during the procedure.

[0093] Figures 22A-22D An exemplary surgical procedure / method for deploying an embolization protection device is shown. Figure 22A An expander 320 assisted by a guidewire 322 is shown. The guidewire 322 is first inserted, and the expander, together with the catheter 314 and the filter 300, is advanced over the guidewire 322. Figure 22B The guidewire is shown being removed and then the dilator 320 is advanced to expose the filter 300. The distal ring 310 is then actuated / released to open radially and form one (or more) seals 310. Figure 22C The expander is shown being retracted and removed. Figure 22D The diagram illustrates the advancement of an aortic valve repair / replacement device catheter 316 through a sheath 314 and a filter 300 to perform the necessary procedure at the aortic valve. As blood flows toward the filter body 300, it traps any embolic fragments, and the seal is configured to remain stable and not dislodge because the filter body 300 is made of a flexible / tough material that will bend as the sheath 314 or catheter 316 moves.

[0094] Figure 23 The alternative embodiment shown in Figure 22 includes a filter body 330 comprising a spiral 332 made of nitinol or any biocompatible material around a flexible filter 330 to facilitate removal of the filter body by keeping the fabric larger in diameter than the filter catheter sheath 314 and smaller than the diameter of the aorta.

[0095] Figure 24 An alternative embodiment is shown, wherein the filter body 340 includes a Nitinol-shaped mesh / woven fabric with an inverted valve structure that can optionally retract into a straight tube.

[0096] Figure 25 illustrates how a physician can push the distal end of the catheter sheath 352 forward to a position where the sheath 352 can pass through the distal seal 354 of the filter. Multiple filter seals (such as intermediate seal 350) adjacent to the flexible filter mesh allow for movement or wiggling of the aortic device catheter 316 and filter catheter sheath 314 closer to the deployment site without dislodging the filter seals, preventing and mitigating embolus displacement.

[0097] Figures 26A-26C The procedure / method for removing an embolic protection device with an exemplary plurality of seals after aortic valve device surgery is shown. Figure 26A This illustrates how, after aortic valve device surgery, embolization fragment 360 is trapped within an embolization filter 362 and the aortic device delivery catheter 316 is removed. A preferred method for removing the filter is to tighten the distal seal 354, for example, using a tightening suture, a deflation balloon, a suture, a spring, or other known methods for sealing the fragment within the filter. Next, Figure 26B It is illustrated that a portion of the distal seal 354 and filter body 362 can be optionally pulled into the intermediate seal 350 portion of the filter body using a wire, spring, suction, or other device. Then, the next intermediate seal 350 is tightened, resulting in a smaller area / volume occupied by the filter body and the debris 360 firmly trapped within the filter 362. This process can be repeated if more intermediate seals are used to plug the filter assembly. Figure 26B The procedure involves steps such as... This makes the filter body 362, with the embolic fragments 360 trapped within it, more manageable / secure when pulled into or near the filter catheter during removal. This reduces the risk of the filter rubbing against the aortic wall and dislodging the embolic fragments or becoming stuck in the filter during device removal. The procedure also ensures that the embolic fragments within the filter cannot flow out of the filter. Like... Figure 23 The helical spring in the filter can also be used to house filter 362. Figure 26C The filter catheter with its compact filter body is shown, along with any debris being pulled back from the catheter or being dragged along. Alternatively, aspiration can be added before removing the filter 362 and catheter sheath 314 to aspirate the embolic debris 360 from the filter 362, or it can be used to aspirate / retract the entire filter body 362 back into the catheter sheath 314.

[0098] Figures 27A-27D Alternative exemplary implementations / methods for using the device in areas such as the carotid artery are shown, wherein blood flow is... Figures 26A-26C The blood flow is reversed in the previous iteration. The filter catheter sheath 370 can be moved forward to the position of the distal end of the catheter sheath 372 through the distal seal 374 of the intermediate filter, as shown. Figure 27BAs shown. Without compromising the integrity of seals 374 and 372, the distal end of sheath 372 can be moved forward to any position between the intermediate seal 372 and the distal seal 374. This allows physicians to safely translate the balloon / stent over plaque 385, as... Figure 27C As shown. A balloon stent (77) can be positioned to empty and then expanded to crush plaque and clear the obstruction, as... Figure 27D As shown. Figure 27D An alternative implementation / method is shown, in which the distal end of the sheath can be advanced beyond the distal seal 374. During the expansion of the balloon / stent 382 over the plaque 485, any embolic fragments 390 that can be released will be captured between the folds of the embolic filter 380.

[0099] Figure 28A It shows Figure 27D The alternative embodiment shown is a catheter sheath 370, wherein the sheath 370 includes drainage holes 415 that, when the balloon / stent 382 inflates, allow continuous blood flow and block blood flow outside the sheath to crush plaque. These holes can be large enough not to become blocked, or multiple holes can be used. Additionally, the balloon / stent 382 may have channels to allow blood flow and also reduce pressure variations. Figure 28B This illustrates how the balloon / stent 382 is emptied after expansion for removal. A preferred exemplary method for capturing the embolus 390 and removing the filter 380 and sheath 370 is to first tighten the intermediate seal 376, as shown. Figure 28C What we see is that fragment 390 is trapped. Figure 28D The next step is shown, in which the distal seal 374 is tightened to make the entire device more compact for removal. However, seals 374 and 376 can be tightened in reverse order with similar results, as blood flow prevents embolic fragments 390 from moving in the opposite direction. The tightened loop can be retrieved either outside or inside the catheter sheath 370, and the entire embolism protection catheter can eventually be removed.

[0100] Intracardiac echocardiography devices and methods Figure 29A A cross-sectional view of an ICE catheter with a flexible probe 610 in a curved position within catheter 612 is shown. The probe, which may be made of an elastic / bendable / hyperelastic / film / stretchable / flexible material, is configured to be straight and flat upon deployment but can be folded or bent in the curved position by a tension application element 616 (which may be a suture, thread, balloon, and / or mechanical lever). Figure 29B In this process, the probe is deployed by releasing tension or by pushing or releasing element 616 from the proximal end of the catheter, such as... Figure 29C As seen in the text. Figure 29A The side view in Figure 29CAs can be seen in the text. Figure 29A The side view in Figure 29D As can be seen, in an alternative implementation, the ICE probe / transducer can also be configured to be bent when at rest and can be biased to a straight position by applying energy or a biasing force.

[0101] Figures 30A-30B to Figures 33A-33D An alternative exemplary implementation of the ICE device is shown.

[0102] Figure 30A A cross-sectional view of an ICE catheter with rigid probes 620 and 621 arranged in a V-shape inside the catheter is shown. Figure 30B Flat probes 620 and 621 in a single plane are shown. Similarly, Figures 31A-31B An example of a square configuration is shown. Figures 32A-32B An example of a U-shaped channel configuration is shown, and Figures 33A-33D An example of an "I"-type configuration is shown, in which two probes 650, 651 are configured side-by-side using a hinge / connector to... Figure 33B The configuration shown is expanded. Figure 33C Alternative exemplary embodiments are shown, in which probes 661, 662, and 663 are arranged in an I-shape or in parallel configuration within catheter 665. Figure 33D The probes 661, 662, and 663 are shown sliding into their fully expanded state. In alternative implementations of any one of the probes 661, 662, and / or 663 themselves, they may be individually expandable / stretchable in a single direction (1D) or in multiple directions (2D, 3D, and / or 4D, where time is the fourth dimension).

[0103] In an alternative exemplary implementation Figures 29A-29D to Figures 33A-33D All the ICE device examples shown can be configured to operate in any location (from within the conduit 612 to a fully expanded / deployed position or any position in between). Furthermore, the probes can be assembled into planar, curved, or any 3D and / or 4D shape.

[0104] Figures 34A-34D Exemplary implementations / methods are shown for multiple rigid probes 660, 661, 662, and 663 that can be assembled / positioned in flower-shaped or cross-shaped locations. Figures 34A-34D Examples of advancements in probe orientation / assembly are shown. These probes can be moved via pulleys, stitching, magnets, hinges, hooks, actuators, motors, and / or fluid mechanisms. In alternative embodiments, there may be more than one probe or fewer than 1,000,000 probes.

[0105] Figures 35A-35CAn exemplary implementation of an alternative mode of probe assembly is shown, wherein the probes are assembled side by side (next to each other / adjacent to each other).

[0106] Figure 36A It shows Figure 34D An alternative implementation, wherein the probe is folded during initial positioning, and then as... Figure 36B The view is expanded to increase the surface area in the final orientation.

[0107] Figures 37A-37E It shows Figures 34A-34D An alternative positioning system in which probes are arranged in a fan-shaped pattern, adjacent to each other. The device can use as many or as few probes as needed. Figures 37A to 37E The progress of probe positioning / arrangement outside catheter 695 is shown. Probes 690, 691, 692, 693, and 694 can be arranged in any order / sequence.

[0108] Figures 38A-38F An alternative shape for the probe is shown, where the probe is shaped like a wedge pieced together, such as... Figure 38F As seen in the diagram, the device can use as many or as few probes as needed, and the probe components can be designed in any shape that allows them to fit together.

[0109] Figure 39A A series of probes with flexible connectors inside the catheter are shown to allow for catheter flexibility while allowing for an increase in surface area.

[0110] Figure 39B , Figure 39C and Figure 39D Exemplary schematic diagrams of various configurations of the final assembly of the probe are shown.

[0111] In all the ICE catheter embodiments described in this application, the probe may be functional both inside the catheter and / or assembled outside the catheter. Further, in alternative embodiments, any of the ICE catheters with the probes described in this application may be steerable. Further, in alternative embodiments, two or more ICE catheters with probes may be stacked or assembled together inside the patient, outside the patient, or partially inside and partially outside the patient. Assembly may be performed using any method known to use electromagnets, magnets, puzzle locks, sutures, ropes, threads, keys, motors, hinges, hyperelastic connectors, bendable / flexible connectors, mechanical connectors, chemical connectors, and / or POSA.

[0112] Novel steerable catheter devices and methods Figure 40An exemplary principle of a compression spring is illustrated, where L0 is the initial uncompressed length, Ln is the fully compressed length, and L1, L2 are progressively shorter lengths. F0 = 0 unit force, and Fn is the maximum compressive force required to fully compress the spring to Ln. Note that the same effect can be achieved by applying the aforementioned displacement to the tension line instead of applying a force to cycle its length, as is commonly known in POSA.

[0113] Figure 41 The current steering configuration is illustrated, where two pull wires 801 and 802 are diagonally opposite each other along the length of the steerable catheter shaft. A force F1 is applied to pull wire 802 on one side, slackening wire 801 on the other side, compressing the elastic steerable section of the catheter to L1, causing the steerable catheter to bend on that side. To straighten, the pulled wire is slacked to F0, and the catheter extends to L0.

[0114] Figure 42 A-42E illustrates the disclosed exemplary principles. Figure 42 A shows the catheter in a relaxed state.

[0115] Figure 42 B illustrates an exemplary method in which the catheter shaft is compressed to Ln by applying a force Fn to the pull wires on both sides. This is a new initial state, which can be achieved when the catheter is fully or partially inserted into the body or when the catheter is on the table.

[0116] Figure 42 C illustrates the bending by relaxing the convex side from Ln to L2.

[0117] Figure 42 D illustrates a further bending process by relaxing the convex side from L2 to L1 while keeping the concave side in Ln.

[0118] Figure 42 E shows the net elongation achieved by slackening the wire while maintaining a slight bend.

[0119] Figure 43 A-43D describes the mechanical advantages of using the pulley principle.

[0120] Figure 43 A shows a simple single pulley 805, where mechanical advantage (MA) = 1.

[0121] Figure 43 B shows a double pulley configuration where mechanical advantage (MA) = 2.

[0122] Figure 43 C shows a three-pulley configuration where mechanical advantage (MA) = 3.

[0123] Figure 43D illustrates an exemplary four-pulley configuration where mechanical advantage (MA) = 4.

[0124] Figure 44A A current / typical catheter is shown, where the mechanical advantage (MA) = 1. In this configuration, all segments of the catheter experience the same tension.

[0125] Figure 44B The disclosed exemplary implementation is shown, in which a mechanical advantage (MA) of 4 is configured in the distal segment S2 while a lower MA of 1 is seen in the proximal segment S1.

[0126] Figure 45A and 45B An exemplary embodiment is shown, configured with various MAs to bend in various segments or in various directions. Furthermore, this exemplary embodiment introduces the concept of MA=0 by having a compression coil (like a bicycle brake cable) to transmit force via a segment without bending that segment. For example, Figure 45B The proximal segment S1 is shown, in which an extension spring 812 is used (like a bicycle cable—transmitting braking force without experiencing any compression). Therefore, when the pull cable 802 is pulled, this segment S1 does not experience any compressive force, thus not resulting in a mechanical advantage (MA = N / A or not applicable).

[0127] Figure 46A Models 46B, 46C, 46D, and 46E illustrate exemplary configurations with various MAs to allow a particular segment to rotate and / or bend. As POSA will know, bicycle cable element 812 (MA = N / A) can also be applied to helical / rotating segments. Figure 46A The spiral configuration in segment S2 is shown to achieve rotation in one direction when the pull wire 802 is pulled. Figure 46B As shown, slackening the pulled cable 802 will cause the guide shaft S2 to rotate back in the opposite direction.

[0128] Figure 46C An exemplary embodiment with three segments S1, S2, and S3 is shown, wherein segment S2 is configured to rotate in one direction using a single drawstring, while segment S3 is configured to rotate in two directions using two drawstrings (one for each direction), as shown. Figure 46D and Figure 46E As shown. In other examples of the implementation, multiple segments can be combined with multiple guy wires.

[0129] Figure 47A An exemplary embodiment is shown with a ring / clamp 830 outside the steerable portion of the guide shaft.

[0130] Figure 47BAn exemplary configuration with MA=2 in the steerable section and a bicycle brake cable configuration 812 in the proximal, non-steerable section are shown. Furthermore, in this exemplary configuration, the cable is connected at both ends of the steerable section.

[0131] Figure 48A and Figure 48B It shows in Figure 47B An example of an alternative implementation method using a drawwire outside the guide shaft is introduced in the text.

[0132] Figure 48C An alternative exemplary implementation of the concept is shown, in which a hydraulic piston is used. If suction is applied, the piston will shorten, causing the guide shaft to bend, as... Figure 48D As shown. Other methods of actuating the piston include fluid, pneumatic, nickel-titanium motor, and electromagnetic methods.

[0133] Figure 48E It shows Figure 48C An alternative implementation involves pressurizing / expanding the piston to bend in the opposite direction.

[0134] Figure 48F An alternative implementation, balloon 843, is shown for deflecting the catheter. One advantage of using balloon 843 is that it can provide support for the catheter against tissue / blood vessels.

[0135] Aortic valve devices Figure 49A An exemplary schematic diagram shows a high and wide frame aortic prosthetic valve with proper positioning without obstructing the coronary ostium. Note that the valve is placed high (on the valve annulus). Figure 49B The image shows a short and narrow frame aortic prosthetic valve, which is poorly aligned, causing coronary ostial obstruction (see arrow). FIG. 49C The image shows a low-profile support with proper placement. Note that the valve is intra-annular. FIG. 49D This illustrates improper placement of a high-profile prosthetic valve, causing obstruction of the coronary ostium (see arrow). Note that the valve is intra-annular. FIG. 49E The improper placement is shown, in which the device is too low below the valve annulus, resulting in perivalvular leakage (see circle). FIG. 49F This illustrates yet another example of improper placement that causes both coronary ostial obstruction (see arrow) and paravalvular leakage (see circle).

[0136] The advantage of this disclosure is that it allows for the secure placement of the prosthetic valve below the coronary artery ostium.

[0137] The advantage of this disclosure is that it allows for the non-invasive attachment of a prosthetic valve to the aortic leaflet and / or aortic wall. This can be achieved without excessively increasing the radial forces against the aortic wall or by deforming the aortic structure with a very rigid and very large prosthetic valve frame in an attempt to mitigate leakage or displacement.

[0138] The advantage of this disclosure is that the prosthetic valve is primarily fixed to the native leaflet and gently fixed to the aortic base / annulus, allowing the prosthetic valve to be less rigid, more compliant, and better preserve the natural elasticity of the aortic wall's compliance / movement / transportation. This is a crucial feature, especially in pediatric and younger patients.

[0139] The advantage of this disclosure is that the prosthetic valve framework has replaceable or removable leaflets to address leaflet calcification or other functional loss during or after surgery (acute and / or chronic (>1 day, >30 days and / or >100 years)).

[0140] An advantage of this disclosure is that the arm fixed to the leaflet is (independently or simultaneously) actuable with or without interference with the body of the prosthetic valve.

[0141] An advantage of this disclosure is that the prosthetic valve leaflet can be placed at the same level as the original leaflet.

[0142] The advantage of this disclosure is that the prosthetic valve leaflet can be fixed to the frame in a manner similar to how the native leaflet is fixed to the aortic wall / annulus, to achieve improved hemodynamics similar to that of a healthy native leaflet.

[0143] An advantage of this disclosure is that the prosthetic valve can have a very low height and be fixed by a non-traumatic arm.

[0144] An advantage of this disclosure is that the prosthetic valve leaflets can be placed below the valve annulus.

[0145] The advantage of this disclosure is that it provides superior protection against perivalvular leakage by using arms and native leaflets to firmly seal the prosthetic valve body, whether with or without a skirt.

[0146] The advantages of this disclosure may include a cover plate with a lower profile and more efficient or simpler design, and an umbrella-shaped flexible leaflet.

[0147] An advantage of this disclosure is that the covering leaflets can be accommodated or configured in both a surgical (rigid) shell and a flexible stent-like shell, which are delivered via catheter or minimally invasive surgery.

[0148] An advantage of this disclosure is that the covered leaflet device can be configured to be used in conjunction with the native leaflets to prevent backflow.

[0149] An advantage of this disclosure is that it can have a spacer coupled to the native or prosthetic leaflet to alleviate regurgitation.

[0150] The advantage of this disclosure may be the option of embolism 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.

[0151] The advantage of this disclosure is the ability to improve surgical outcomes by creating a bloodless zone at the surgical site (e.g., by blocking / shunting blood and flushing with saline) to enable optical visualization, similar to or superior to invasive surgical techniques.

[0152] The advantage of this disclosure is the ability to configure / integrate blood management systems / methods with temporary valves, filters, heart pumps, sensors, actuators, drug delivery anti-calcification, anti-plaque, plaque / calcified lesion destruction, leaflet cutting / dissection / removal, and electrical, thermal, magnetic, energy-based, and / or mechanical tools to treat vascular / cardiovascular diseases. Additionally, it enables the use of commonly used tools normally retained for invasive surgery in minimally invasive or catheter-based procedures.

[0153] The advantage of this disclosure is that it allows for the integration of a heart pump into the hand blood management system during and after surgery.

[0154] The advantage of this disclosure may be that it allows for blood management devices and methods that allow the heart to be perfused by maintaining blood flow to the coronary arteries.

[0155] The advantage of this disclosure is that it allows for the integration of a dedicated catheter or blood flow pathway as a temporary device or permanent implant into the coronary artery during and / or after surgery, with or without the implantation of a prosthetic valve.

[0156] The advantages of this disclosure can be modular, removable (box-like), or integrated retrievable prosthetic valve.

[0157] FIGS. 50A-50D An exemplary embodiment of a prosthetic aortic valve 1040 is shown, comprising a frame 1042 with actuating arms 1020, 1024 and a skirt 1062.

[0158] FIGS. 51D-51G An exemplary method for implanting a prosthetic valve is shown. FIG. 51D A schematic diagram of an aortic valve with guidewire 1005 is shown. FIG. 51E The prosthetic valve body is shown in a narrowly constrained state, while arm 1020 extends to allow space for leaflet insertion. FIG. 51FA prosthetic valve is shown on top of the native leaflet LF. Finally, the body of the prosthetic valve is dilated (either by self-dilation or by balloon dilation) to securely and non-invasively attach to the native leaflet, as shown in 51G.

[0159] FIGS. 52A-52F Exemplary embodiments and methods are disclosed, wherein arms 1020, 1024 can be independently actuated to securely and non-invasively capture the native aortic valve leaflets. Arms 1020, 1024 are preferably self-biased to close onto body 1040; and are connected to body 1042 via member 1018. Member 1018 can be any attachment device, such as a weldment, spring, hinge, suture, adhesive, screw, flexible joint, bendable joint, etc. FIG. 52A An exemplary schematic diagram of an aortic prosthesis device 1040 with leaflet grasping arms 1020 and 1024 is shown. Note that for simplicity, only two leaflets LF and two arms are shown. Typically, there are three leaflets for an aortic valve, so the prosthesis device 1040 may have at least one arm to grasp at least one leaflet. Preferably, the prosthesis device will have at least three arms for the three leaflets. The arms may be attached to the device 1040 via a member 1018. The member 1018 may be a suture, hinge, weld, glue, screw, and / or rivet. The arms may be elastic, hyperelastic, shape memory, rigid, and / or flexible materials that can be configured to bias toward the prosthesis device. They may be made of nitinol, metal, plastic, ceramic, or a combination thereof. The delivery catheter 1012 includes a lever arm 1016 for providing the desired mechanical advantage using sutures 1032, 1034 to actuate arms 1020, 1024 to create a separation to allow insertion of the leaflets, such as... FIG. 52B and FIG. 52C As shown. Lever arm 1016 can be an arm capable of swinging, bending, expanding, articulating, motor, and / or any manner known from POSA, preferably with some mechanical advantage to actuate or apply bias force / motion to open arms 1020, 1024 while allowing the lever arm to retract / fold within the delivery conduit. Note: Additional mechanisms may be available to actuate the lever arm itself to shift / translate it from a low profile (position 1: contained within the conduit profile) to position 2 (expanded / extended position) to better apply the force required to actuate arms 1020, 1024. Lever arms 1016 themselves can be configured to be actuated individually or simultaneously. Each of the arms can be configured to be actuated individually, sequentially, or independently, as... FIG. 52B As shown. Alternatively, it can be actuated simultaneously, such as... FIG. 52C As shown. Then as FIG. 52D As shown, the device 1040 is advanced above the leaflet, and the leaflet is captured by lowering an arm above it, as... FIG. 52EAs shown. The arm or device may have barbs or other friction elements to firmly and non-invasively grasp the leaflets. If necessary, the device can be repositioned, redeployed, or removed by re-actuating the arms 1020, 1024. The device can then be detached from the delivery system. In some alternative embodiments, the device can be reversibly detached from the delivery catheter by having a retrieval element on the device 1040.

[0160] FIGS. 53A-53F It shows the relationship with FIGS. 52A-52F A similar alternative implementation includes an actuable lever arm 1046, the difference being that the actuation stitch is below (far side) the lever arm position. FIG. 53F An example of the configuration of lever arm 1046 is shown, wherein the lever drops / rotates to provide the necessary lever arm to apply a biasing force to arms 1020, 1024.

[0161] FIGS. 54A-54B It shows FIGS. 52A-52F The disclosed alternative implementation allows for multiple re-grasping, repositioning, redeployment, and evaluation / assessment of the native aortic valve leaflets while the prosthetic valve body is fully dilated. Furthermore, the arm can have a wide range of motion for better placement, remedy, removal, and / or retrieval of the device, such as... FIG. 54A and FIG. 54B As shown. FIG. 54A The diagram illustrates arm manipulation in the fully expanded state of the aortic prosthesis device 1040 with leaflet grasping arms 1020 and 1024. Note that for simplicity, only two leaflets (LF) and two arms are shown. Typically, for the aorta, there will be three arms and three 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 upwards to an inverted position, such as... FIG. 54A As shown. FIG. 54C This is an exemplary implementation of a lever arm that requires lifting / actuation / rotation (outside the conduit profile) to provide the necessary mechanical advantages. The lever arm can be lifted / rotated using any means such as stitching, screw mechanisms, hydraulic, electrical, chemical, or pneumatic.

[0162] Arms 1020, 1021, and 1024 can be multiple components, such as... FIG. 55A As shown. FIG. 55B Arms 1020 and 1021 are shown, which are two components fastened via member 1018 and configured to be biased toward each other. For example, in one configuration, arm 1020 may be made of a shape-formed, hyperelastic material (such as nitinol), and the dashed line of arm 1020 indicates the unbiased shape-formed position. The arm may be attached at its base or at any position between the arm and the device. FIG. 55CExamples of 1020 and 1021 made of continuous material / structure are shown.

[0163] FIGS. 56A-56C An alternative embodiment of the device 1040 is shown, wherein it is configured to have a pair of arms (1021, 1020 and 1024, 1027) to grasp both the outer 1020, 1024 and the inner 1021, 1027 of the formal leaflets. These arms may be mechanically biased (via hinges, gears, etc.) or resiliently self-biased, for example using nitinol. See commonly owned prior art for further description. In this exemplary embodiment, the arms are made of nitinol. The outer arm 1020 is actuated using suture 1032, and the inner arm 1021 is actuated using suture 1052, while the outer arm 1024 is actuated using suture 1034, and the inner arm 1027 is actuated using suture 1056.

[0164] FIG. 57A and 57B It shows FIG. 53F An exemplary embodiment of the lever arm is shown.

[0165] FIG. 58A and 58B It shows FIG. 54C An exemplary embodiment of the lever arm is shown.

[0166] FIG. 59A An exemplary embodiment of the disclosure is shown, wherein the actuable arm and native tissue docking frame have a non-invasive friction element 1070 designed to engage with native leaflets and / or the aortic wall.

[0167] FIG. 59B A disclosed exemplary embodiment of a modularly replaceable insert 1045, comprising leaflets, is shown within a framework that integrates with the native leaflet and the aortic wall. The insert can be reversibly attached using common techniques such as pressure fitting, torsion fitting, threaded fitting, chemical, electrical, and / or magnetic fitting.

[0168] FIG. 59C It shows FIG. 59B An exemplary embodiment additionally includes a non-invasive annular gripping / engaging / friction element 1070. At this location and / or outside the prosthesis frame, a skirt 1062 (including sponge, gel, fabric, film, mesh, braid, balloon, and / or fiber) can be used to enhance the prevention of paravalvular leakage.

[0169] FIG. 59D A schematic diagram of the aortic valve is shown. FIG. 50A The apparatus shown.

[0170] FIG. 59FAn exemplary ultra-low profile embodiment of frame 1042 is shown, configured to include a cover sheet or flexible film flap 1075. The cover sheet 075 can be attached to frame 1042 using part 1072, which includes any common fastening / welding / adhesive / screw fixing / fixing device. FIG. 59F The image shows a prosthetic aortic valve 1040 during diastole, with a covering 1075 stopping the blood flow back to the left ventricle (see arrow).

[0171] FIG. 59G It shows the period of contraction FIG. 59F The exemplary valve 1040 embodiment shown has a cover 1075 that flexes open as blood flows from the left ventricle into the aorta (see arrow).

[0172] FIG. 59H and 59I Another exemplary embodiment of an ultra-low profile frame 1042 with leaflets is shown. In one embodiment, the leaflets may be configured to attach only to the base of the frame 1042. In another alternative embodiment, the leaflets may also be attached to struts or height extensions added to the frame 1042.

[0173] FIG. 59J A strut-equipped aortic valve is shown in a schematic diagram. FIG. 59H The apparatus shown.

[0174] Figure 59K to FIG. 59O It shows FIGS. 59A-59D A variation of the exemplary implementation in which the prosthetic flap / insertion is generally attached / extended below the body of the frame 1042.

[0175] FIG. 60A The Jena valve from PCT / US2023 / 080979 was copied. FIG. 22D The entire application, including US10575947B2, is incorporated herein by reference in its entirety. FIG. 60B A schematic diagram of the positioning element 1064a, the main body 1042a, and the skirt 1062a is shown. Note: The suffix "a" in the reference numerals connects to the equivalent feature. FIG. 60C Only the positioning element 1064a of the Jena valve relative to the frame 1042a and the skirt 1062a is shown. FIG. 60D An alternative embodiment of the disclosure is shown, wherein the positioning element 1064 includes a skirt 1062. FIG. 60E An alternative embodiment of the disclosure is shown, wherein the positioning element 1064 extends beyond the skirt 1062.

[0176] FIG. 61AA schematic diagram of the Jena valve is shown, including the positioning element 1064a, the main body 1042a, and the skirt 1062a. FIGS. 61B-61D The Jena valve was shown. FIG. 61A (A relatively shorter or more compact disclosed exemplary implementation.) FIG. 61B The disclosed exemplary embodiment is shown, wherein the actuator booms 1020, 1024 are wide and configured to provide both anchoring to the leaflets and sealing against the leaflets (therein) and the skirt 1062. FIG. 61C It shows FIG. 61B and FIG. 61C An alternative implementation wherein the arm 1020 includes an extension beyond the skirt 1062.

[0177] FIG. 62A A prosthetic device 1040 with an actuable arm featuring a skirt 1062 is shown to prevent paravalvular leakage. The skirt can be hollow, balloon, covered stent, or any covered structure, expandable and compressible structure, perforated structure, fabric, braid, membrane, coating, membrane pad, sponge, sponge-like structure, or any structure that can prevent blood leakage. FIG. 62B , 62C Figure 62D illustrates examples of prosthetic valves with various embodiments of position markers 1064 to assist in positioning and grasping via actuated arms 1020, 1024, 1028, 1021.

[0178] In an alternative exemplary embodiment, the position marker 1064 may also be simultaneously or independently actuable or repositionable, whether or not the prosthetic valve body 1042 is interfered with, manipulated, moved, or actuated.

[0179] FIG. 62E and 62F An exemplary disclosure is shown in which a valve implant has one or more valve retrievable components 1300, 1310, 1320 to assist in the removal of the valve 1040 at a later date after implantation (after complete removal from the delivery system). The retrievable components 1300, 1310, 1320 may be suture coils, hooks, magnets, threads, filaments, or any generally known component that aids in post-implantation retrieval (see common patents for additional details). These retrievable components may optionally have features that aid in detection, such as radiopaque, echogenic, magnetic, fluorescent, etc. The components may be polymeric, metallic, ceramic, nitinol, etc. The retrievable components may also be actuable, deployable, or remotely triggerable to have a low profile when not needed and be easily graspable or detectable (for easy retrieval) when needed. In some embodiments, the retrievable components are used to stabilize the frame.

[0180] FIG. 62G An exemplary disclosure is shown, in which a prosthetic valve 1040 includes a valve housing 1042 and a replaceable valve 1045. The valve housing may typically include a primary fixation element that is more or less secured to tissue after implantation, such as: frame 1042, arms 1020, 1022, 1024, 1026, skirt 1062, etc. The replaceable valve 1045 includes a prosthetic leaflet 1045 with a replaceable frame 1045. Additionally, the replaceable frame may include a retrievable element. In some embodiments, the retrievable element is present on both the valve housing 1042 and the replaceable valve 1045. For example, a stud, hook, or slot in the valve housing 1042 may be used to stabilize the valve housing 1042, while the retrievable element on the replaceable valve 1045 may be used to remove, disassemble, and replace the replaceable valve 1045. In an alternative implementation, the replaceable valve 1045 has tearable valve leaflets and a secondary frame for easy removal of the failed prosthetic valve leaflets. One advantage of this disclosure is that it allows for easy repair should the valve fail at any future date, either post-implantation (or during implantation). This alleviates the need for cutting the failed prosthetic valve or removing the entire failed prosthetic valve, which would require cutting surrounding tissue (including the original leaflets).

[0181] In aortic stenosis, a common cause is severe calcification of the native leaflets. This leaves very little space for blood flow and / or restricts leaflet movement. Similarly, prosthetic tissue valves typically fail after 7 to 15 years due to leaflet calcification. Therefore, it is beneficial to completely remove the failed prosthetic valve or (fully or partially) cut the prosthetic leaflet before replacing it with a new prosthetic valve. However, once the calcified leaflet is cut, blood flow and blood pressure will be affected until the new prosthetic valve is deployed / implanted. This problem can be alleviated by placing a temporary valve downstream or upstream of the coronary sinus. If the temporary valve is placed upstream of the aortic valve (or coronary sinus), blood flow to the coronary arteries is not affected. If the temporary valve is placed downstream of the coronary sinus, there needs to be a way to supply blood flow to the coronary arteries. In either case, it is crucial to ensure that blood flow to the coronary arteries and downstream organs is free of any debris, thrombus, or emboli that could form during the removal of the diseased original valve or the failed prosthetic valve. This can be achieved by placing a downstream filter immediately after the valve (e.g., in the ascending aorta) and before the coronary sinus. Alternatively, the filter can be placed downstream of the coronary sinus, in which case a tube 1164 can be used to provide debris-free blood to the coronary arteries, such as... FIG. 63A As shown. As is evident for POSA, sealing of blood flow to the coronary arteries can be achieved using commonly known devices, including tight-fitting tubes, tapered tubes, inflatable balloons, foam cuffs, stents, O-rings, etc. The seal can be a portion of one or more tubes 1164. FIG. 63BAn exemplary balloon sheath 1155 is shown that simultaneously seals two tubes 1164.

[0182] Moreover, as POSA can understand, FIG. 63A In an exemplary configuration of the implementation, the positions of the temporary valve 1140 and the filter 1150 can be interchanged; that is, the filter 1150 can be placed immediately upstream of the temporary valve 1140, such as... FIG. 63B As shown. Alternatively, the functions of the filter and the temporary valve diaphragm can be combined into a single implementation. In an alternative implementation of the temporary valve diaphragm, its function can be changed from being a one-way valve (flow in one direction) to a two-way valve (flow in both directions). This can be achieved mechanically, electrically, electronically, chemically, magnetically, using software, fluid triggers, etc. The same valve can be switched / converted / changed to always remain in the open position (allowing flow in both directions) or to function normally as a check valve (opening in forward flow and closing in reverse flow). Alternatively, the temporary valve can have any configuration that allows selective flow control, which is obvious to POSA.

[0183] A temporary valve can be placed. FIGS. 64A-64C Various configurations of a temporary valve placed upstream of the coronary sinus (immediately below the native valve or between the coronary ostium (CA) and the native valve) are shown. This ensures that flow to the coronary arteries remains unimpeded. FIG. 63A and 63B Similarly, filters can be used to alleviate embolic fragments during surgery (not shown here for the sake of brevity).

[0184] FIG. 64A A stable upstream temporary valve 1130 is illustrated using a stent and / or filter 1150 and a docking member 1160. Note that the stent may be hollow and incorporate (or include) a filter, port, and / or a secondary temporary valve (in addition to 1130). The docking member 1160 may be rigid, flexible, elastic, plastic, hyperelastic, straight, curved, single-wire, multi-wire, braided, coiled, laser-cut, metallic, stretchable, variable-length, polymer, etc., and may be detachably attached to both the stent 1150 and the temporary valves 1130, 1140. FIG. 64B An alternative embodiment is shown, in which temporary valves 1130, 1140 are stabilized / supported or held in place using catheter shaft 1170, whether or not docking member 1160 is included. The catheter originates from the retrograde direction. FIG. 64C An alternative embodiment is shown, wherein the catheter shaft 1170 originates from the ventricle (anterograde). In the alternative embodiment, the temporary valve may have FIGS. 60A-64CThe combination of the embodiments shown.

[0185] One advantage of this disclosure is that temporary valves 1140 and 1130 can be configured to continue to function as permanent valves. In alternative embodiments of the disclosure, temporary valves 1130 and 1140, filter 1150, and / or docking member 1160 may include sensors, motors, controllable length, drug delivery systems, wireless, RFID, actuators, visualization systems, energy delivery or monitoring systems, patient monitoring devices / systems, and / or cardiac pumps (e.g., left ventricular assist devices), including any other components as understood by POSA. One advantage of this disclosure is that by placing the prosthetic valve downstream or upstream of the native valve (where the tissue is relatively undamaged or has a more suitable anatomy), any trauma from removing a diseased native valve or a failed prosthetic valve can be mitigated. As POSA understands, the temporary filter and temporary valve positions may be interchangeable or incorporated into the same structure and used only for short periods, and may be removed at the end of the procedure or at a later date.

[0186] FIG. 65A An exemplary embodiment of filter 1150 and temporary valve 1130 is shown. The filter includes a mesh 1148 and a self-sealing or sealable port 1145 for advancing various catheters. The mesh can be any known filter commonly used in the medical device industry. Port 1145 can be any common device in the catheter industry that allows catheter passage, such as a self-sealing membrane, barrier, and / or valve. Temporary valve 1130 can be a three-leaflet design, a single-leaflet, a double-leaflet, or more than one-leaflet valve, a check valve, a duckbill valve, a disc valve, a cone valve, a low-profile valve, etc. Alternatively, temporary valve 1130 may also have a port similar to port 1145 to allow catheter passage while maintaining a pressure differential across the port / valve. Alternatively, filters 1148, 1150 may be inside the catheter when blood is configured to flow through it.

[0187] FIG. 65B An exemplary embodiment of a temporary valve 1130 with a stabilizing catheter 1170 and a docking member 1160 is shown.

[0188] FIG. 65C An exemplary configuration of temporary valves 1130, 1140, and / or filter 1150 is shown, including a coronary artery feed vessel 1164, a sealable or self-sealing catheter port 1145, and a one-way valve 1142. It is known for the POSA that the seal between the tube 1164 and the coronary sinus can be achieved using any of the following exemplary methods: tight-fitting tubing, longer tubing, tapered tubing, O-ring-based concepts, expandable, inflatable, fillable, compressible cuffs, balloons, sutures, clips, etc.

[0189] FIG. 65D This illustrates the use of a double-sided loop balloon to create a seal at the coronary sinus, with a tube passing through the cross-section of the balloon. The size and shape of the ports can also be interchanged with the valve configuration.

[0190] FIG. 66A An exemplary disclosed variation is shown in which the previously deployed prosthetic valve 1100 is removed and replaced with a new prosthetic valve 1040. FIG. 66A The placement of the temporary valve 1140 is shown (note that, for simplicity, the filter 1150 and tube 1164 are not shown), and the cutting device 1110 is advanced and placed toward the existing prosthetic valve 1100. FIG. 66B In this process, the existing prosthetic valve is removed using any method commonly known to POSA (such as cutting, coring, punching, scraping, grinding, lapping, RF energy cutter, US, ablation, ultrasonic cutter, ultrasonic homogenizer / pulverizer, wire cutting, liquid jetting, fluid jetting, laser, chemical ablation, etc.).

[0191] FIG. 66C The illustration shows a temporary valve in place and an existing prosthetic valve that has been excised and removed. In this exemplary embodiment, a significant portion of the native valve leaflet is also cut off. Alternatively, the leaflet may be partially cut to allow for increased gripping via arm 1020 or body 1042 and / or skirt 1062. FIG. 66D The placement of the novel prosthetic valve 1040 is shown, which is secured by arms 1020, 1021, 1022, 1024, 1026, and 1027 that grasp the leaflets (or extend beyond the leaflets' anatomy) from both sides. However, as is apparent from the disclosure, there are various ways to attach it, including using clips, sutures, barbs, augers, pins, adhesives, and fusion achieved via chemical, electrical, mechanical, or ultrasonic methods. FIG. 66E Alternative methods for grasping and securing valves are illustrated. Any type of valve (temporary or permanent) disclosed may include a one-way valve, port, or tube. It may be a low-profile design, including but not limited to designs derived from mechanical, tissue, and industrial valves. The valve may be self-expanding, expandable, compressible, bendable, torsion-compatible, retractable, etc., to improve compliance with catheter-based and / or minimally invasive delivery.

[0192] FIGS. 67A-67H A method for replacing a failed aortic valve with a new aortic valve is shown, with or without visualization. FIG. 67A The guidewire 1005 is shown passing through the failed valve 1100.

[0193] FIG. 67BA catheter 1012 inserted above a guidewire is shown. A temporary valve 1140 and optionally a filter 1150 may be placed in series. A cuff 1200 is deployed. Note that the cuff 1200 may be a balloon, hemispherical, concave, cup-shaped, bowl-shaped, expandable umbrella-shaped structure, disc, stent, or any component used or configured to restrict or shunt blood flow. Further, the cuff may have additional ports to allow multiple catheters outside the catheter 1012. An optional and exemplary conduit 1164 may be used to maintain blood supply to the coronary artery. Alternatively, the cuff 1200 and conduit 1164 may be placed / deployed using separate, independent, and dedicated catheters before, after, or in conjunction with the catheter 1012 (working together). Alternatively, the temporary valve 1140 and filter 1150 may be deployed outside the catheter instead of the cuff 1200. Any of the temporary valve and filter described in the disclosure can be incorporated into the catheter 1012 with ports or orifices 1210, 1220 to allow blood flow, and the cuff or balloon can be sealed along the vessel. Alternatively, during removal of the failed valve 1100, a separate removable catheter (within or outside the catheter 1012) can be used in parallel with the temporary valve, filter, and cuff to guide and filter blood flow and provide a safe working area.

[0194] FIG. 67C The disclosure shows placement of an additional cuff 1200, and ports 1230, 1240 for flushing the working area around the failed valve (native or prosthetic valve) with a clear, semi-transparent, or transparent liquid (such as heparinized saline) to aid visualization using a fixed or steerable camera 1250 (obvious to POSA). Safe visualization methods are not limited to optics; any other visualization techniques commonly known in the medical or engineering industries, such as ICE catheter echography, can be used. POSA recognizes that while saline visualization is preferred, it is an optional step redundant when using standard imaging techniques such as echography, fluoroscopy, IVUS, ICE, infrared, OCT, etc. Optionally, in alternative embodiments, port orifices 1210, 1220 may include an LVAD motor / pump to unload pressure across the aortic valve.

[0195] FIG. 67DAn exemplary cutting tool for removing a failed valve 1100 is shown. As POSA will understand, any known technique can be used to capture and remove the failed valve using transcatheter techniques. If desired, multiple catheters can be used to remove the failed valve 1100 from both anterograde and retrograde paths. Additionally, the failed device can be removed as a whole or in segments. In one exemplary embodiment disclosed, only the leaflets of the prosthetic valve 1100 are cut and removed. In this case, a new prosthetic valve 1040 will be deployed within the frame of the failed prosthetic valve 1100. Note: In alternative embodiments, POSA will understand that this procedure or method can also be used to completely or partially cut and remove the native valve.

[0196] FIG. 67E The stage after removal of the failed device 1100 is shown. Note: One advantage of this disclosure is that once the temporary valve is in place, the patient can undergo recovery (before or after removal of the failed valve 1100), and the procedure can be continued at a later time or date.

[0197] FIG. 67F The placement of a novel prosthetic valve 1040 using an actuable arm is shown to enhance valve 1040 fixation and sealing. More than one arm (1020, 1021, 1024, 1027, or 1026) can be used. Additionally, the arms can be used in pairs (e.g., 1020 and 1021), and more than one pair of arms (e.g., 1024 and 1027, 1020 and 1021) can be used. However, as POSA will understand, this method can be used to deliver any conventional and / or commercially available valve (without an actively actuable arm). An optical camera can be used for visualization along with saline flushing. The camera system can be integrated (embedded or as a retractable / steerable extension of the catheter). Alternatively, a separate camera system can be inserted inside or outside the catheter.

[0198] FIG. 67G Exemplary embodiments are shown in which the actuation flow-enhancing cuff 1200 is removed, disabled, or deactivated to allow free blood flow. This allows for real-time or conventional evaluation of the new prosthetic valve. In alternative methods / implementations, the catheter can be retracted from the prosthetic valve leaflets during evaluation. In alternative implementations, a larger segment of the catheter can be retracted and replaced with a significantly smaller catheter during evaluation and subsequent repositioning or manipulation of the arms 1020, 1022, 1024, 1026 of the prosthetic valve 1040 to improve the quality of evaluation. POSA recognizes that a debris filter can always be used throughout the procedure. Moreover, the debris filter can be part of this system or an external commercial system, or both.

[0199] In this step, the new prosthetic valve 1040 can optionally be repositioned, redeployed, or completely removed from the catheter (and, if necessary, replaced with a valve of a different size or shape). Valve 1040 can be repositioned, redeployed, completely removed, and replaced with different valves multiple times. Note: If necessary, the flow improvement cuff 1200, temporary valve 1140, filter 1150, ports 1210, 1220, 1230, and 1240 can be repeatedly / multiplely deactivated / reactivated, disabled / enabled, opened / closed, inflated / emptied, opened / closed, or deactivated / activated to allow for assessment, manipulation, or removal / replacement of any of valves 1040 and 1100 during the procedure.

[0200] FIG. 67H The new prosthetic valve 1040 is shown after the delivery catheter 1012 has been removed. Any other aids used for monitoring, aiding rapid recovery, fine-tuning the implant / valve, or assessing cure (such as filters, temporary valves, sensors, or any implementation described in the disclosure or known from the posa) may be removed during the procedure or at a later time or date.

[0201] FIGS. 68A-68D A method for deploying the aortic valve without cutting the native leaflet is shown.

[0202] FIG. 68A The diagram illustrates the placement of a guidewire via an exemplary aortic valve. While this exemplary method is shown to reach the aortic valve via a conventional retrograde approach (from the femoral artery), the procedure can alternatively be performed via an antegrade approach (e.g., from the femoral vein, via the right atrium (through the interatrial septum), left atrium, and left ventricle to the aortic valve).

[0203] FIG. 68B The diagram shows the insertion of a catheter 1012 (not shown for simplicity) over a guidewire 1005 and the deployment of a filter 1150.

[0204] FIG. 68CThe placement of the prosthetic valve 1040 is illustrated. An advantage of this disclosure is that the actuating arm can be used as a position marker and / or for attachment to the leaflet and / or for sealing paravalvular leaks. Additionally, a dedicated position marker 1062 can be used in conjunction with actuating arms 1020, 1022, 1024, and 1026. An advantage of this disclosure is that the arms can be actuated independently or simultaneously. An advantage of this disclosure is that the delivery catheter includes a deployable filter 1142. An advantage of this disclosure is that the filter can remain in place for an extended period post-implantation (preferably 1 to 30 days or 1 to 180 days) and be removed at a later time or date to reduce or eliminate the need for anticoagulants. An advantage of this disclosure is that conventional valves (without actuating arms) can also be used. An advantage of this disclosure is that the valve can be evaluated or repositioned in both a compressed and fully dilated state. An advantage of this disclosure is that the prosthetic valve may have retrievable structures such as sutures, coils, and hooks (see the co-owned patent for additional description) to facilitate retrieval. One advantage of this disclosure is that the filter 1150 can be paired with one-way, two-way and / or configurable / switchable / selectable valves.

[0205] FIG. 68D An implanted prosthetic valve 1040 is shown. One advantage of this disclosure is that the prosthetic valve 1040 may include a valve housing 1042 and a replaceable valve 1045.

[0206] FIGS. 69A-69D This demonstrates a conventional deployment method without cutting the native leaflet and with visualization and management of coronary blood flow.

[0207] FIG. 69A and FIG. 68A same.

[0208] FIG. 69B include FIG. 68B It also includes ports 1210 and 1220 with a one-way valve 1140 embedded within the catheter, a cuff 1200, and ports 1230 and 1240 for flushing with a clean solution such as heparinized saline. The valve structure can then be optically visualized using a camera 1250. Alternatively, in an alternative embodiment, port holes 1210 and 1220 may include an LVAD motor / pump to unload pressure across the aortic valve.

[0209] FIG. 69C and FIG. 68C Similarly, it adds the ability to visualize the internal structure between the two sheaths 1200.

[0210] FIG. 69D The end result is shown, with FIG. 68Dsimilar.

[0211] FIGS. 70A-70F An exemplary method for aortic valve deployment in the case of cutting the native leaflet is shown.

[0212] FIG. 70A and FIG. 68A same.

[0213] FIG. 70B include FIG. 68B It also includes a temporary valve 1140 and a tube 1162 supplying blood to the coronary arteries. Optionally, a filter 1150 may be used.

[0214] FIG. 70C and FIG. 68B Similarly, and additionally, the native leaflet is cut and removed using, for example, a blade 1110. Alternatively, any combination of energy sources known as laser, RF, ultrasound, chemical, or POSA can be used.

[0215] FIG. 70D A valve with its original leaflets cut is shown. The leaflets can be cut completely or partially.

[0216] FIG. 70E The placement of the prosthetic valve 1040 via manipulators 1020, 1021, 1024, and 1027 is illustrated. (Compared to...) FIG. 68C Similarly, suture 1032 is used for actuator 1020, suture 1034 for actuator 1024, suture 1052 for actuator 1021, and suture 1056 for actuator 1027. Once the physician is ready to test the valve's effectiveness, he can reversibly switch the temporary valve 1140 from a one-way valve to a two-way valve, allowing blood to flow freely in both directions.

[0217] FIG. 70F A fully implanted prosthetic valve 1040 with an alternative arm configuration is shown. One advantage of this disclosure is that more than two arms can be positioned at any location along the height of the valve.

[0218] Figure 71 illustrates an alternative method for deploying a prosthetic aortic valve with cut native leaflets while using saline flushing for visualization.

[0219] FIG. 71A and FIG. 69A or FIG. 68A same.

[0220] FIG. 71B and FIG. 69BSimilarly, and including ports 1210, 1220 with temporary one-way valves via catheters, a cuff 1200, and ports 1230, 1240 for flushing with a solution such as heparinized saline. The valve structure and / or other structures between the two cuffs 1200 can then be optically visualized using a camera. Alternatively, in an alternative embodiment, port holes 1210, 1220 may include an LVAD motor / pump to unload pressure across the aortic valve.

[0221] FIG. 71C The procedure demonstrates the use of, for example, blade 1110 to cut and remove the native leaflet. This surgery can be performed under optical visualization.

[0222] FIG. 71D A valve with its original leaflets cut off is shown. The original leaflets can be completely or partially cut off and removed.

[0223] FIG. 71E The placement of the prosthetic valve 1040 via manipulators 1020, 1021, 1024, and 1027 is shown. (Compared to...) FIG. 20 Similarly, suture 1032 is used for actuator arm 1020 and suture 1034 for actuator arm 1024, suture 1052 for actuator arm 1021, and suture 1056 for actuator arm 1027. In an exemplary embodiment, once the physician is ready to test the valve's efficacy, he can reversibly switch the temporary valve 1140 from a one-way valve to a two-way valve, allowing blood to flow freely in both directions.

[0224] FIG. 71F A fully implanted prosthetic valve 1040 with an alternative arm configuration is shown. One advantage of this disclosure is that more than two arms can be positioned at any point along the height of the valve. Note: In the event of failure of the prosthetic valve 1100, the same procedure can be followed to cut and remove the failed valve 1100, or alternatively, only the prosthetic leaflet of the failed valve 1100 can be cut and removed.

[0225] FIG. 72AAn exemplary support body 1078 with a flexible cover sheet 1075 is shown, which can cover the gap between the leaflets to alleviate reflux. The cover sheet can be flexible, rigid, stretchable, non-stretchable, hollow, balloon, covered support or any structure with a cover, expandable and compressible structure, perforated structure, fabric, braid, film, mesh, fiber, coated, membrane pad, sponge, sponge-like structure, or any structure that can alleviate valvular reflux when placed over the gap between the leaflets. The cover sheet can be made of metal, plastic, biological, non-biological, ceramic, hyperelastic, shape memory, composite, fabric, braid, machined, 3D printed, or any combination known from POSA. The cover sheet can include at least one structure, two structures, or three or more structures. It can have a single leaflet cover, a double leaflet cover, or three or more leaflet covers. It can be of any shape, circular, pizza-shaped, triangular, trapezoidal, square, elliptical, umbrella-shaped, etc. It can be corrugated, folded, smooth, fan-shaped blade structure, Japanese-style foldable / sliding fan-shaped structure, with or without slits. The cover sheet can have elements, reinforcing members, lines, or sheets along the edges and sides to configure and optimize its shape during diastole (to minimize reflux) and during systole (to maximize blood flow).

[0226] In an alternative implementation, FIG. 72A A stent structure 1078 is shown, which engages with the wall / pore of the valve directly below the coronary ostium or approximately at the level of the leaflets and is configured to support a cover sheet 1075. In one exemplary embodiment, the cover sheet 1075 folds downward during diastole (solid lines in 1075 and LF) to cover the gap between the leaflets to alleviate regurgitation. During systole, the native leaflets open (dashed lines), and the cover sheet 1075 (dashed lines) folds upward and away from the leaflets to allow blood flow. The folding of the cover sheet can be passive (moving along with blood flow) or active (remotely controlled or using logic, fluid mechanisms, or programming mechanisms). In passive mode, the degree or shape of the cover sheet folding can be controlled by adjusting the flexibility / flexural modulus of each section / segment / piece / part of the cover sheet 1075 to configure the structure of the cover sheet.

[0227] FIG. 72B It shows FIG. 72AA variation of the exemplary embodiment shown is in which the cover sheet 1075 is supported via a low-profile connector 1076. Connector 1076 can be a suture, thread, stent structure, tube, etc. Furthermore, connector 1076 can be rigid, elastic, hyperelastic, flexible, bendable, stretchable, adjustable, intelligently controlled, etc. Moreover, the low-profile connector 1076 is supported by connector 1077, which is configured to attach to the base of the aorta shown. Connector 1077 can have barbs, clasps, alligator teeth, or any mechanically actuated (non-hyperelastic or steel-based) or self-biased (shape memory, hyperelastic, nitinol-based) gripper.

[0228] FIG. 72C It shows FIG. 72A Variations of the exemplary embodiments shown, wherein the cover sheet 1075 is supported by a low profile member 1076, which in turn is supported by a stent structure 1078 above the coronary artery ostium or well above the tip of the leaflet.

[0229] FIG. 72D It shows FIG. 72B The exemplary alternative device is shown. Although the cover sheet 1075 is shown here as a single disc shape, it can be of any geometry, optimized for a patient-specific condition (reflux).

[0230] FIG. 73A and 73B An exemplary embodiment of a spacer 1080 with arm 1020 during diastole is shown. The spacer 1080 is configured to fill gaps to alleviate reflux. Although the shape of the spacer is shown as cylindrical (with a circular cross-section), the shape and cross-section can be any geometry, including star-shaped, triangular, flat, crescent-shaped, elliptical, etc. Furthermore, the spacer 1080 can be expandable, compressible, stretchable, inflatable, porous, solid, linear, sponge-like, to name just a few. Finally, the spacer 1080 can be intelligent, and its shape can be remotely changed electronically, hydraulically, mechanically, or chemically, but is not limited to these examples. For example, in one exemplary embodiment, the spacer can be controlled to expand during diastole to alleviate reflux and contract during systole to maximize blood flow.

[0231] FIG. 73C and 73D The figures during the systolic phase are shown separately. FIG. 73A and FIG. 73B Exemplary implementations.

[0232] Although FIGS. 73A-73DThe exemplary embodiment shows a single spacer 1080 attached to a single leaflet, but more than one spacer device may be attached to the leaflet. Moreover, more than one leaflet may be attached to one or more spacer devices.

[0233] FIG. 73E and 73F The spacer 1080 is shown attached to various brackets 1078, 1077 in configuration. FIG. 73E In the middle, the support 1078 is positioned at the level of the leaflet tip. For example... FIG. 73F As shown, the spacer 1080 is attached to both the support 1078 above the leaflet and the support 1077 below the leaflet via the member 1076.

[0234] In an alternative embodiment, the spacer 1080 may be replaced with a prosthetic valve 1040, configured to alleviate regurgitation.

[0235] FIG. 74A and 74B An exemplary embodiment of a cap 1090 with arm 1020 during diastole is shown. The cap / cover / disc 1090 is configured to fill the gap to alleviate backflow. Although the shape of the cap 1090 is shown as cylindrical (with a circular cross-section), the shape and cross-section can be any geometry, including star-shaped, triangular, flat, crescent-shaped, etc. Furthermore, the cap can be expandable, compressible, stretchable, synthetic, 3D printed, molded, extruded, manufactured, film-laminated, reinforced composite structure, expandable, porous, solid, linear, sponge, to name just a few. Finally, the spacer can be intelligent, and its shape can be changed remotely, electronically, hydraulically, mechanically, or chemically, but is not limited to these examples.

[0236] FIG. 74C and 74D The figures during the systolic phase are shown separately. FIG. 74A and 74B Exemplary implementations.

[0237] Although FIGS. 74A-74D The exemplary embodiment shows a single spacer 1090 attached to a single leaflet, but more than one spacer device may be attached to the leaflet. Moreover, more than one leaflet may be attached to one or more caps 1090 pieces.

[0238] FIG. 74E and 74F The attachments to arms 1020 and 1022, and the attachment to the diastolic phase, are shown respectively. FIG. 74E ) and contraction period ( FIG. 74F An exemplary embodiment of the cover sheet / film 1075 of the petals in ).

[0239] As POSA understands, the disclosed embodiments for the aortic valve can be applied to other heart valves (e.g., mitral, tricuspid, pulmonary valves), venous valves, or any other valve or component in a human / robot / bionic body.

[0240] FIG. 75A A commercially available mechanical valve is shown. One of its problems is the exposed metal. Although the valve is coated with a carbon coating to improve blood compatibility, it is still thrombogenic and requires lifelong anticoagulant medication. Furthermore, the valve makes an annoying clicking sound and requires surgical implantation.

[0241] One of the disclosed exemplary embodiments is to cover the exposed metal (including any or all of the long-term implant embodiments described throughout this document) with damping, shock absorption, sound absorption, and / or endothelial growth promoters, coatings, and / or coverings. Examples include films, fabrics, braids, meshes, interwoven, fibrous paper, etc., made of commonly known tissue growth promoting materials such as eptfe, pet, or polyester.

[0242] One of the disclosed exemplary embodiments involves replacing the metal leaflets with a polymer or composite material. The polymer valves can be rigid, flexible, sheet-like, silicone, rubbery, reinforced plastic, 3D printed, fabric, fiber / thread / nickelinol reinforced fabric, and / or the like. These leaflets can be selectively coated or covered. Examples of composite materials can be reinforcing fibers, nickelinol reinforced substrates, such as fabrics, metals, braids, ceramics, and / or plastics.

[0243] One of the disclosed exemplary embodiments is to reduce the travel of complete valve closure, thereby reducing water hammer effects and stress on the valve leaflets. For example, the height of the implant can be configured such that the valve closes within a 45-degree (preferably about 20-degree) travel.

[0244] One of the disclosed exemplary embodiments is to reduce the effect of leaflet closing force or velocity by adding silicone, rubber, springs, mesh, braids, fabrics, or plastic dampers. Other reduction methods known to POSA include creating grooves, embossing, friction, channels, indentations, bubbles, multiple holes, or flow paths.

[0245] The disclosed exemplary implementation is FIGS. 75B-75J The image shows a flexible cover 1075 that replaces metal leaflets with a leaflet-like concept. FIG. 73B A top view of a frame 1405 with a stationary and rigid horizontal member 1410 is shown. In an alternative embodiment, the frame 1405 includes a skirt 1062. FIG. 73C A side view of frame 1405 is shown. FIG. 75DThe flexible cover sheet 1075 is shown as a petal-shaped material in the shape of a disc. FIG. 75E The flexible disc-shaped prosthetic valve 1075 is shown bending and allowing blood flow. FIG. 75F A disc obstructing blood flow is shown below the horizontal member. It thus functions as a one-way valve. POSA will understand that the only moving part of the device is the flexible bending of the cover 1075. Therefore, the risk of friction and abrasion is eliminated. Furthermore, the frame can be made rigid (for surgical implantation). The cover 1075 can be removably and replaceably attached, sutured, and / or bonded to the horizontal member 1410 and / or to the frame 1405.

[0246] In an alternative embodiment, the prosthetic valve can be delivered and implanted via catheter by configuring the frame 1405, horizontal member 1410, and cover plate 1420 to be sufficiently flexible, stretchable, lockable in two different states / positions, compressible, foldable, bendable, and / or assembled (including any manner known to POSA). Any attachments (such as arms, skirts) and visualization, spacers, and / or leaflet cutting methods / implants discussed in this application or known to POSA can be used to securely implant the device into the aortic valve.

[0247] In an alternative embodiment, the device frame 1405 may have a curved landing area 1425 for the cover sheet 1075, which is configured to improve hemodynamics / blood compatibility. FIG. 75G and 75H The states during systole and diastole are shown respectively.

[0248] In an alternative embodiment, the device frame 1405 may have a base with a hole 1430, such as FIG. 75I As shown.

[0249] In an alternative embodiment, the device frame 1405 may have a base with any configuration or design of flow mode 1440, optimized for improving hemodynamics / blood compatibility, such as FIG. 75J As shown.

[0250] FIGS. 75E-75J Alternative implementations may include multiple (more than one) leaflets / covering sheets 1075. FIGS. 75B-75JThe leaflet / covering plate 1075 can be a single structure or multiple structures assembled together. The leaflet can be attached to the horizontal member 1410 and / or to the frame 1405 using any known fastening, gluing, welding, pressure fitting, riveting, or other methods. Alternatively, the trap 1420 can be directly attached to the aorta, the aortic leaflet. Alternatively, the trap 1420 can be directly or indirectly attached to the assembly or tissue, frame 1405, and / or horizontal member 1410 via connectors. Alternatively, both the leaflet / covering plate 1075 and the horizontal member 1410 can be configured as a single unit or independently to be replaceable / replaceable during surgery (acute) and at a later date or time (e.g., after 15 years).

[0251] Mitral valve devices and methods: Trauma-free annulus devices and methods: FIGS. 76A-76B This is a disclosure for treating valvular regurgitation (e.g., heart valves such as the mitral, tricuspid, and pulmonary valves). However, this concept can be applied to any valve in the body. FIG. 76A A schematic diagram of a normal mitral valve is shown.

[0252] FIG. 76B A diseased mitral valve with regurgitation due to annular dilation is shown. One exemplary solution / method / apparatus disclosed is the deployment of at least one atraumatic ring adjacent to the annulus. For example, the ring can be placed above (upstream) or below (downstream) the annulus. For example, a spiral ring can be placed above and below the annulus and / or leaflets. The ring is allowed to fully encapsulate with tissue over an extended period (typically >30 days). In subsequent procedures, the ring is gradually tightened / compressed over one or more visits until the gap between the leaflets is reduced or completely closed to alleviate the regurgitation.

[0253] In alternative embodiments, the valve can be configured to automatically tighten to a predetermined diameter or shape over a period of time. This can be achieved by using biodegradable pads, biodegradable tubes, biodegradable coatings, or any other similar means, wherein the ring is acutely held in an expanded state and contracts or compresses over a period of time. One disclosed example is inserting a spring of known diameter, stretching it using a biodegradable tube or pad, and inserting it into the cross-section of the ring. Over a period of time, the tube or pad degrades or dissolves, and the spring compresses the ring to a predetermined shape or size. Alternatively, the ring can be filled with a biodegradable material. Alternatively, a balloon can be used to control the shape and size both during the acute phase and over a period of time. Alternatively, remotely controlled motors, actuators, wireless, RF, fluid, thermal, chemical, or mechanical devices can be used to remotely control the tightening. In alternative examples, material properties such as creep, sublimation, etc., can be used.

[0254] FIG. 77A A side view of a non-invasive ring tightening device 1510 based on an exemplary ring is shown. In this exemplary design, a bracket design derived from a tube is used, and a typical compression spring 1530 with a circular cross-section is fastened, welded, sewn, or interlaced. POSA understands that the ring is compressed by tightening the rope through the compression spring 1530. While this is an exemplary method, any other method can be used to compress the ring, change its shape or size over a period of time.

[0255] FIG. 77B A top view of an annular tightening device 1510 based on an exemplary ring is shown. Alternative embodiments of these can be configured to be any shape that can more closely approximate the shape of an anatomical structure (such as a D-shape) or any patient-specific contour.

[0256] FIGS. 77C-77H Various exemplary cross-sectional profiles 'A-A' of ring 1510 are shown. Ring 1510 can be made from a compression spring with a typical circular profile, a support with a compression spring, or a flat compression spring with an elliptical, rectangular, triangular, trapezoidal, C-shaped, S-shaped, or any other suitable profile. The compressible spring 1530 can be made from wire, sheet, tube, or 3D printed. It can have a typical support, be braided, interwoven, coiled, or any suitable device. On the tissue mating side, the ring can have micro-barbs or other friction elements that do not cause trauma to the tissue or cause minimal trauma to the tissue during either the acute phase (during repeated deployment and repositioning) or the chronic phase (which should not cause any ischemia, necrosis, conduction block, etc. over a period of time). This differs from current techniques that use augers to fasten to deep tissue (>1.5 mm). In a preferred embodiment, the friction element or barb is less than 1.5 mm, 1.0 mm, 0.75 mm, 0.5 mm, 0.25 mm, 0.1 mm, 0.01 mm and / or 0.0001 mm.

[0257] FIGS. 78A-78D Various exemplary embodiments of the ring 1510, made of wire, sheet, strip, or tube, are shown. Alternatively, it can be molded, 3D printed, machined, laser cut, assembled, sewn, and / or woven.

[0258] FIGS. 79A-79DVarious exemplary shapes are shown, such as rings, C-shapes, D-shapes, etc. These can be made of metal, plastic, ceramic, and can be composite, layered, monolithic, multilayered, assembled, covered, coated, rotationally wound, molded, encapsulated, etc. Friction elements can be knots, barbs, V-shapes, W-shapes, S-shapes, flat or rounded barbs, rough surfaces, rough fabrics, glue-based, screws, barb anchors, or any other device known to POSA, to securely attach to the tissue at least until tissue encapsulation is complete. These friction elements can be completely non-invasive (non-tissue-penetrating) or penetrating (with minimal trauma). The device may not be a continuous structure, but rather small segments, disconnected or connected chains that can be assembled in the body or on an OR table. Sutures, cords, magnets, drawstrings, and any suitable techniques based on device segment configuration can be used for assembly or camouflage to achieve loading inside the catheter. Recapture, retrieval, and readjustment elements can be radioactive, radiopaque, echogenic, RFID, or any method generally known to POSA to improve visualization.

[0259] In an exemplary alternative implementation, the ring 1510 may be configured to initially and gently juxtapose with the valve annulus for a sufficiently long period of time (e.g., 30 days, 60 days, and / or 360 days) to ensure complete tissue encapsulation, and then begin tightening to accelerate retrograde remodeling of the heart / valve annulus. This can be achieved via any of the methods known to POSA, such as a) using a biodegradable material embedded in a spring of smaller diameter over time, b) a biodegradable material embedded in a shape-defined nitinol material with the desired final valve annulus shape, c) a nitinol motor, d) pneumatic, fluid control, or e) manual tightening via catheter to tighten the ring 1510 after tissue encapsulation.

[0260] FIGS. 80A-80L An exemplary method for mitral valve annulus repair is shown. FIG. 80A This image shows a lesion of the mitral valve with a dilated annulus and a gap G in the mitral valve leaflets, resulting in MR. A guidewire 1005 is first introduced via the interatrial septal approach. Typically, the guidewire is passed through the femoral vein approach point, ascends through the inferior vena cava, enters the right atrium, and finally passes through the septum into the left atrium. Alternatively, it can enter the left atrium via the jugular vein. Alternatively, it can enter via the femoral artery, aortic valve, left ventricle, and then the left atrium.

[0261] FIG. 80BA catheter is shown inserted into the left atrium above a guidewire. Once the catheter is in place, the guidewire can optionally be retracted and removed. A ring 1510 is loaded in a folded configuration and is shown being pushed out. Alternatively, the ring can be compressed, or both compressed and folded. If it is a C-shaped ring, another alternative is to straighten it within the catheter. Alternatively, any loading device can be used, which is typically used in catheters anywhere in the body. One advantage of this disclosure is that it allows the stent to be folded, flattened, and loaded along its length, thereby reducing the cross-sectional area of ​​the catheter. Additionally, it can be bent to further reduce the catheter's profile. Typically, the stent is compressed radially / circumferentially, which increases the size of the catheter.

[0262] FIG. 80C The device 1510 is shown fully in its expanded state. The device can be detachably held to the delivery catheter 1550 using commonly used catheter techniques such as sutures, threads, tubes, etc. For example, FIG. 80C The device is shown to be held in place using a removable radial stitch through tube 1580. Adjustable / retractable component 1540 is connected via torque cable 1570.

[0263] FIG. 80D The device 1510 is shown in a contracted (compressed) state. This can be achieved by pulling the radial stitch 1560 through the tube 1580 or by the actuator 1570. The actuation of the actuator 1570 can be via rotation, pulling, tightening, expansion / expansion, pneumatic, RF, remote, wireless, electrical, electronic, electric, gear drive, tooth drive, etc.

[0264] FIG. 80E A device 1510 flush with conduit 1550 is shown. This can be achieved by retracting conduit 1580.

[0265] FIG. 80F A device 1510 is shown that positions the catheter 1550 above the valve by turning it.

[0266] FIG. 80G The device 1510 is shown in an expanded state. The degree of expansion can be controlled using known catheter techniques (such as, for example, echocardiography) to adjust the size of the device 1510 before or after size selection. Alternatively, intelligent force sensors or size sensors or mechanical, electrical, or fluid surface contact sensors, imaging, etc., can be used to ensure proper juxtaposition and placement.

[0267] Controlled juxtaposition can be achieved by actuating 1570 or by pulling in radial stitches 1560 via tube 1580.

[0268] FIG. 80HAn alternative and optional method is shown, which uses a balloon to ensure juxtaposition, by inflating the balloon to compress the device 1510 against the atrial valve / foramen. This compression can also be used to securely insert / engage a non-invasive friction element to the valve annulus / tissue.

[0269] FIG. 80I The implanted device 1510 is shown. All delivery systems have been disassembled and removed. Optionally, in an alternative embodiment, the actuator 1570 may remain attached to the implant and secured percutaneously or subcutaneously to continue adjustment. Optionally, the actuator 1570 may be integrated with a sensor for continuous assessment of regurgitation. After sufficient time of robust tissue encapsulation of the device 1510, it may be tightened to reduce the gap between the leaflets, such as... FIG. 80K As shown. Note that this tightening can occur over a period of time (once a day, once a week, once a month, or once a year) or all at once. Alternatively, some controlled tightening can be configured via the elastic recoil of the material or other material properties. In alternative approaches, ring 1510 can be configured to tighten easily but be more difficult to expand, or a hyperelastic material with hysteresis (different periods of stagnation) or an interlocking mechanism that prefers tightening over expansion can be used.

[0270] FIG. 80L The final state of device 1510 is shown, in which reflux is completely treated or relieved.

[0271] FIGS. 81A-81C An exemplary embodiment is shown that uses a NiTiNO strip cut from a tube laser to create a control ring 1510. FIG. 81A This shows that ring 1510 remains in the expanded position, with FIG. 80F similar. FIG. 81B The nitinol strip is shown. As is known from POSA, the strip is shaped to be funnel-shaped, thus expanding and contracting when pulled into or out of the catheter shaft 1550. Furthermore, each of the strips can be controlled individually or simultaneously using sutures 1560 to both rotate the loop 1510 or attach / remove the loop 1510 to the strip 1590. FIG. 81C A pattern of a laser-cut tube with stitching holes for steerability and ring fasteners is shown.

[0272] FIG. 81D An exemplary embodiment of a non-invasive anchor 1595 is shown, similar to a staple. FIG. 81E Alternative implementations with loops that allow stitches to pass through or provide attachments are shown. For example, the loops can be used for mounting, tightening, actuation, and / or deployment. FIG. 81F An alternative implementation of a non-invasive anchor that engages with tissue through expansion is shown.

[0273] One advantage of this disclosure is that device 1510 allows for multimodal treatment, for example, the disclosure allows for or is compatible with edge-to-edge repair and chordae tendineae repair. One advantage of this disclosure is that annular repair can be performed before or after edge-to-edge repair or chordae tendineae repair. One advantage of this disclosure is that device 1510 allows for multimodal treatment, for example, the disclosure allows for or is compatible with prosthetic valve replacement. One advantage of this disclosure is that perforation repair can be performed before or after valve replacement. One advantage of this disclosure is that annular repair forms a supporting scaffold for the replaced valve.

[0274] One advantage of this disclosure is that it allows for chronic tightening over a period of time, preferably after a lag of 30 days.

[0275] One advantage of this disclosure is the use of external forces (such as...) FIG. 80H The aforementioned balloon can securely insert friction elements (barbs, coils, screws, anchors, and / or wires) into the valve annulus tissue, thereby allowing for acute and / or chronic tightening without the risk of dislodgement.

[0276] One advantage of this disclosure is that the friction element can be pushed in, twisted, or rotated to engage with tissue.

[0277] In one exemplary method, a ring 1510 comprising a friction element with minimal penetration (preferably less than 1.5 mm, 1.0 mm, 0.5 mm, 0.25 mm, and / or 0.1 mm) is inserted into the left atrium, and then positioned around the valve annulus under standard fluoroscopic and echo-guided conditions. The friction element of the ring is anchored to the tissue via a balloon 1585 or by twisting / rotating / pulling / pushing the ring to securely engage or attach it to the valve annulus. The ring is then deployed, resulting in one- or two-step tightening (acute and / or chronic). Acute tightening during dilation can be configured via the natural elastic recoil of any elastic material. Chronic tightening can be configured to follow the natural dilation and contraction of the beating heart via unidirectional, preferably progressive tightening, or via remotely controlled tightening or biodegradable controlled tightening.

[0278] Leaflet augmentation devices and methods: FIG. 82A The annular stent 1510 is shown combined with an expandable member 1805, which first pierces the leaflet surface from the atrial side to the ventricular side and then expands to support / enhance the leaflet.

[0279] FIG. 82B A retractable valve annular stent 1510 is shown combined with an expandable or foldable member 1810, which first pierces the leaflet surface from the atrial side to the ventricular side and then expands to support / enhance the leaflet.

[0280] FIG. 82C A non-invasive annular stent 1510 is illustrated in combination with an expandable or foldable arm 1820 having a gripping element that grasps the leaflets from both the atrial and / or ventricular side. The gripping element may be actuable. The element 1820 may be configured to be hinged, flexibly attached, or strapped to the annular stent 1812, allowing it to rotate / pulsate along the native leaflets (maintaining normal leaflet movement). The element 1820 may optionally include leaflet springs (similar to the arms and grippers in the commonly owned patent), foldable sheets, spacers, or prosthetic valves. Any combination of the exemplary embodiments listed above in the provisional patent, cited patent, or commonly owned patent may be applied interchangeably to produce new embodiments.

[0281] FIG. 83A and 83B Atrial and lateral views are shown of a mitral valve prosthesis leaflet enhancement 1820 paired with an annular stent 1510, the mitral valve prosthesis leaflet enhancement 1820 having rotating / pulsating leaflets. The valve is in the open (constricted) position.

[0282] FIG. 83C and 83D Atrial and lateral views are shown of a mitral valve prosthesis leaflet enhancement 1820 paired with an annular stent 1510, which has rotating / pulsating leaflets. The valve is in the closed (diastolic) position.

[0283] FIG. 83E Atrial and lateral views are shown, respectively, of an alternative embodiment of a mitral valve prosthesis leaflet enhancement 1820 paired with an atraumatic and compressible annular stent 1510, the mitral valve prosthesis leaflet enhancement 1820 having a rotating / pulsating leaflet 1820 and a stationary leaflet 1820. The valve is in the open (constricted) position.

[0284] FIG. 83F The following are shown respectively from the annular support 1510: FIG. 83E An atrial and side view of an alternative embodiment of the mitral valve prosthesis leaflet reinforcement 1820, which has a rotating / pulsating leaflet 1820 and a stationary leaflet 1820. The valve is in the closed (diastolic) position.

[0285] As is evident in POSA, any of the leaflet components (rotating or fixed) can include leaflet reinforcements such as gaskets, prosthetic leaflets, or leaflet springs. Commonly used materials can be used, such as Japanese fan-shaped designs, fabrics, woven fabrics, balloons, nitinol, and biodegradable materials. These components can be rigid or flexible and can mimic the movement and flexure of natural, native leaflets.

[0286] Rotational leaflet reinforcements can be attached to any one or more leaflets. Leaflet reinforcements can be attached to the posterior leaflet of the mitral valve, or alternatively to the anterior leaflet or both. Reinforcements can also lengthen or fill pores and clefts in the native leaflet, increasing leaflet function and therapeutic efficacy.

[0287] The leaflet reinforcement is attached to a highly compliant nitinol stent 1510, which gently resists the valve annulus with a maximum expansion of 0-15%. Additionally, the stent may have components such as sutures, threads, or springs around its circumference to prevent excessive expansion. Once tissue has grown and completely encapsulated the annulus, the stent is firmly attached to the annulus and allows reverse remodeling (the annulus returning to its natural state) to occur. The stent can also be used alone. Additionally, the stent can also be used with another device that allows the annulus to contract when it is able to, unlike the overly rigid current devices. The stent can be degraded over time using biodegradable materials or remain in situ, but the outward pressure on the annulus is so low that it does not hinder reverse remodeling of the annulus and pushes the stent inward. The high compliance of the stent additionally prevents trauma to the annulus because less pressure is applied against the tissue wall.

[0288] Stents can also be used as support stents in valve replacement therapy because they do not expand significantly. They function like tissue and create a tight ring for the valve replacement device to be fitted into.

[0289] AI can be used to indicate the required compliance on each stent based on the size of the annulus. Alternatively, its shape can be designed to apply more pressure in areas where the annulus is more significantly recessed.

[0290] This article cites and incorporates in its entirety into EP3912595 ( FIG. 84A ) and US11083572B2 ( FIG. 84B The family of valves. EP3912595 shows a leaflet reinforcement, but lacks annular tightening and spacers. US11083572B2 shows a spacer attached to an annular frame, but the frame is not tightened and the leaflet reinforcement / spacer does not rotate.

[0291] FIGS. 85A-85C An exemplary embodiment of a retractable annular ring 1510 paired with a rotating / pulsating leaflet reinforcement is shown, the retractable annular ring 1510 with or without spacers. The rotating leaflet reinforcement 1820 highlights a unique advantage of this innovation. Pairing the rotating leaflet reinforcement with the retractable non-invasive ring 1510 highlights another unique advantage of the disclosure. Another advantage of this disclosure is that the leaflet reinforcement is actuable (see cited co-owned patent) to firmly grip the leaflets using friction elements including tiny barbs <1 mm.

[0292] FIG. 86A and FIG. 86B An alternative exemplary embodiment is shown, including a retractable ring 1510 and a leaflet reinforcement 1820 with a secondary prosthetic leaflet 1825.

[0293] In all of these embodiments, the annular element can be tightened during or after surgery, before or after tissue encapsulation. One advantage of having a tightening element in an annular stent is that it completely or partially unloads the body load or strain onto the tightening suture / tether / belt / mechanism / piece.

[0294] In all of these embodiments, the tightening of the valve annulus can be performed gradually, taking advantage of tissue adhesion and device encapsulation to reduce trauma caused by high acute forces on the anchor (as in current devices where the valve annulus tightens immediately during surgery). Additionally, designs for non-traumatic anchors or anchorless devices are permitted to minimize or eliminate tissue trauma to the valve annulus or its surrounding area.

[0295] Anti-calcification vascular devices and methods: Figure 87 Several exemplary embodiments are shown, including a single or pair of electromagnetic pulse / wave (EMP) elements 1910 wound around a body part. Element 1910 may include coils, solenoids, windings, meshes, braids, fabrics, conductive paths, wires, ions, electromagnetic waves, antenna cables, radiation, energy, and other known electronic systems. Alternative embodiments include at least one coil element 1910 or a pair of coil elements 1910 that generate the desired EMP. These coil elements 1910 may be part of a sleeve, clothing, pad, adhesive patch, patch, and / or bandage. The duration of treatment can range from seconds, days, weeks, months, years, and / or decades. Treatment can be continuous or intermittent.

[0296] In alternative embodiments, the coil can be placed outside or inside the blood vessel. Placement inside the blood vessel can be similar to stent placement using a catheter. In alternative embodiments, the coil can be placed near tissues or organs (e.g., gallbladder, kidneys, bladder, heart valves, coronary arteries, etc.).

[0297] Current shockwave therapy incorporates high-power pulse generators, which pose a safety risk. Some new technologies demonstrate the advantage of combining two shockwave generators (SWGs) using interferometric modes to increase power via positive interference.

[0298] The advantages of this disclosure include the ability to generate ideal shock wave (SW) energy at the treatment site using lower total energy by focusing and / or redirecting beam energy through the use of acoustic reflectors (AR) or matching layers (ML). Acoustic reflectors are typically air or other materials with high acoustic impedance mismatch, such as the air-blood / urine / saline interface. For example, POSA will know that the use of a gas-inflated balloon in a blood vessel will result in total reflection of the shock wave. Meanwhile, the matching layer has an acoustic impedance comparable to or close to that of each medium, resulting in up to 100% transmittance and 0% reflection.

[0299] Figure 88 An exemplary embodiment of a shock wave generator / transducer that uses spark energy from physiological saline between two electrodes to generate a shock wave is shown. The entire housing may optionally be configured inside or outside a catheter or catheter balloon. A backing layer may be configured as a reflector (R) or a damper, or a combination thereof. The backing layer may be used to focus, diffuse, deflect, or generate an interference pattern for the shock wave (SW). It may be curved, straight, continuous, blocky, identical, matched, variable, or different acoustic impedance or beamforming characteristics. A matching layer may be used to maximize the transfer of SW energy to the target tissue. Further, the matching layer may be optional. When the SWG (and optionally configured with R and ML) is used without a balloon, energy can be generated and transferred by flushing the space with a compatible fluid, such as physiological saline.

[0300] Figure 89 An exemplary embodiment of focusing shock wave energy using a balloon reflector is shown. 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 shock waves from a shock wave generator SWG, such as... Figure 89 As shown.

[0301] In one exemplary method, a balloon catheter 1970 is inserted at the disease site using typical interventional surgical techniques. The balloon 1950 is then inflated, and a secondary balloon 1960 is inflated. The steerable secondary catheter 1980 is then steered to position the secondary balloon 1960. Focusing can be confirmed using low-energy test shockwaves, finite element analysis (FEA), or artificial intelligence (AI). The shockwave energy is then delivered to the site.

[0302] In some embodiments, the secondary balloon 1960 may be pre-configured in a specific position relative to the guidewire tube 1990 and the shock wave generator SWG. The secondary balloon 1960 may optionally be fixed during translation but free during rotation.

[0303] In some implementations, the secondary balloon 1960 can be manually, via FEA, via AI, or is either real-time or pre-configurable, has user-adjustable focus, and has a support structure to provide good support and prevent any displacement under shock wave energy.

[0304] SWs can be generated via electric sparks, ultrasonic transducers, lasers, flammable or explosive substances / fluids / gases, and / or any implosion or explosion that produces a SW. Alternatively, the phased array of the SWG can be programmed to generate steerable and focused SWs.

[0305] The advantage of this disclosure may be that this application and Figure 89 The focusing method / apparatus disclosed herein can be applied to any of the embodiments described in US11432834B2, US11622780B2, US11696799B2, US11766271B2, US20210338258A1, US9867629B2, US10555744B2, US20230329731, US20230380849, US20230404605, US20240008886, US11950793, WO / 2022 / 094523, 20220015785, US11779363, US20230310073, and US11771449, all of which are incorporated herein by reference in their entirety.

[0306] Visualization of interventional surgery: Figure 90 An exemplary embodiment of a catheter-based balloon 2015 with a camera 2010 mounted on an internal tube 2020 is shown. The balloon 2015 can be inflated using a clear liquid, gas, or saline solution 1920. As POSA will understand, the camera 2010 can be configured to rotate and translate along the internal tube 2020.

[0307] Figure 91 An exemplary embodiment of a catheter-based balloon 2015 is shown, and includes a camera 2010 mounted on a steerable shaft 2030 within the balloon 2015.

[0308] One application where optical visualization can be helpful is during plaque destruction using shockwave therapy. However, shockwaves can potentially damage the camera.

[0309] Figure 92An exemplary embodiment configured for shock wave, calcified stone, or plaque destruction is shown, comprising: a catheter-based balloon including a shock wave generator SWG and filled with clear fluid 1920; a balloon 2050 mounted on a steerable shaft 2030 inside the balloon 2015; and a camera 2010 inside the balloon 2050. As is known from POSA, if the balloon 2050 is filled with clear gas while the main balloon is filled with liquid, the shock wave will not be able to penetrate and will reflect away from the gas-filled secondary balloon 2050 due to acoustic mismatch, thereby mitigating any damage to the camera 2010.

[0310] The advantage of this disclosure can be that it allows for application and... Figure 92 The visualization methods / apparatus described herein can be applied to any of the embodiments described in US11432834B2, US11622780B2, US11696799B2, US11766271B2, US20210338258A1, US9867629B2, US10555744B2, US20230329731, US20230380849, US20230404605, US20240008886, US11950793, WO / 2022 / 094523, 20220015785, US11779363, US20230310073, and US11771449, all of which are incorporated herein by reference in their entirety.

[0311] Figure 93 It shows the inside of the blood vessel wall Figure 90 Implementation method.

[0312] Figure 94 It shows Figure 91 In an alternative implementation, the balloon 2015 includes a sealable port 2080 through which a robotic catheter 2070 or an interventional device catheter 2070 can be advanced outside the balloon for a desired intervention. Optionally, a steerable camera shaft 2030 and a camera 2010 can be advanced through the same or different ports 2080. Note: Figure 94 Two such ports 2080 are shown, and the vessel wall 2060 is not shown for simplicity.

[0313] Figure 95An alternative exemplary embodiment is shown, in which two collapsible, self-opening umbrella-shaped seals 2110 are used as part of a blood flow shunt catheter 2030. The umbrella-shaped seals 2110 can be self-opening when pushed out of the catheter or sheath 2100 and retract when pulled back into the catheter sheath 2100. A blood flow shunt catheter port 2095 is provided, through which blood can flow downstream via 2090 and through the distal seal 2110. The blood flow shunt catheter 2130 also includes a saline port 2120 through which saline 1920 can be continuously flushed to produce a clear, transparent optical medium. In the exemplary embodiment, a steerable sheath 2030 with a camera 2010 can be used. Although not shown, it is apparent to POA that robotic and other device catheters can be used to perform procedures inside or outside the lumen of a blood vessel.

[0314] Figure 96 Alternative exemplary embodiments are shown, wherein the umbrella-shaped sealer 2110 provides a seal against the sidewall to provide a saline-flushed, bloodless pocket. The sealer may have an actuable anchor, a removable anchor, a movable anchor, aspiration, and any other means of actively abutting against the wall to produce a seal. Alternatively, the sealer may passively abut against the wall by deploying a strut, a secondary balloon or a separate cage structure, a backing support against the posterior wall, a more rigid catheter, bending to generate push from the opposing / posterior vessel wall or structure, a stent structure, a self-expanding cage / stent structure, increasing the saline flow / flushing to produce positive pressure replacement (pressure slightly above blood pressure), increasing saline circulation by aspirating old saline and continuously or intermittently flushing with new saline, and / or any other means available on the POA for providing adequate juxtaposition and a bloodless zone. The bloodless area can then be used to perform surgery manually, robotically, 2070, under visual guidance using a camera 2010. AI-assisted, FEA-assisted, and or similar techniques known in POSA in endoscopic surgery can now be advantageously employed in catheter interventions within or beyond the lumen of blood vessels / organs / tissues / cells.

[0315] Figure 97 It shows Figure 95 In the alternative embodiment described, a balloon 2140 is used instead of an umbrella-shaped seal 2110 to achieve a seal.

[0316] POSA understands that reinforced support structures for critical components (such as cameras) within or outside balloons 2015 and 2050, or any related structures / components, allow for a low profile during deflation. For example, this could involve using sutures or fiber reinforcement / mesh inside balloon 2015 and expandable stent structures outside balloon 2015 (and / or sealer 2110) and / or using separate secondary catheters to provide external support.

[0317] POSA will also understand that flow diversion is not always necessary. This is because temporarily stopping the blood supply to non-critical areas can be considered safe. In such scenarios, the use of a diversion (via port 2095) is optional and can achieve bloodless zones or intermittently generate bloodless zones for short periods via the upstream seal, either with or without a downstream seal and with flushing using saline alone.

[0318] Another advantage of this disclosure is that the steps for creating a bloodless zone can be programmed to occur automatically when requested by the surgeon or when visual confirmation / feedback is required, through the use of AI, simulation, and robotics technologies. This allows physicians to focus on the surgery and frees them from performing non-value-added tasks. Additionally, during extended surgical times, the position or pressure of the seal can be moved or adjusted to ensure no trauma is caused by pressure or blood flow at the seal. POSA recognizes that critical sensors can be incorporated into the surgical procedure to continuously monitor patient health using integrated sensors within or outside a visualization system, standard patient monitoring methods used during robotic surgery, interventional procedures, or standard medical procedures.

[0319] A prosthetic aortic valve employing an actuating arm and gripper to grasp onto the leaflets, significantly reducing the risk of device displacement and device size. These methods and implementations involve pre-implantation cutting of diseased leaflets, with the option of optical visualization, while maintaining blood flow to the coronary arteries during the procedure. Prosthetic valve implementations include replaceable leaflets and low-profile frames. Additionally, methods and implementations exist for novel left atrial appendage devices that maximize the preservation of atrial appendage functionality while minimizing the risk of thromboembolism and arrhythmias. Methods and implementations of embolism protection devices that minimize the risk of embolism. Intra-cardiac echocardiography devices that can be assembled internally to increase transducer size, thereby improving image resolution and quality. Novel steerable catheter devices that enhance steerability and compatibility with robotic surgery. Non-invasive and retractable mitral valve annulus repair devices with pulsating prosthetic leaflets. Non-invasive or interventional methods and devices using electromagnetic energy to improve body calcium. Systems, methods, and implementation methods for achieving optical visualization in vascular interventions by using a clear fluid to shunt and / or divert blood.

[0320] List of reference numerals The following is a list of the reference numerals / markers used in this application:

[0321] General considerations As those skilled in the art will understand, the various examples, methods, implementations, incorporated references and aspects described and claimed herein may be combined, in whole or in part, without limitation throughout this application, without regard to chapters, headings or technical fields.

[0322] The methods, apparatus, and systems are not limited to any particular aspect, feature, or combination thereof, and the disclosed embodiments do not require any one or more specific advantages or problem-solving. For all of the described embodiments, the steps of any method need not be performed sequentially.

[0323] As used in this article, the “and / or” used between the last two elements in a list refers to 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.” As used herein, the “and / or” used between the last two elements in a list 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”, etc., up to “10”, or between “1 and 2”, between “1 and 3”, etc., up to “1 and 10”, or between any other combination of numbers from “1 to 10”, for example, the value can be between 8 and 10.

[0324] As used herein, the terms “connection” or “fastening” generally refer to physical coupling or connection, and unless explicitly stated otherwise, the presence of intermediate elements between coupled objects is not excluded.

[0325] All concepts, methods, and implementations are presented with consideration for current and future technological advancements, such as their use with or without human intervention, in conjunction with robotics, AI, hardware, software, in-person, remote, and / or program-driven surgery.

[0326] All implant embodiments described herein may optionally be covered, wrapped, coated, etc., to improve biocompatibility and tissue interface. Suitable coverings may be fabrics, meshes, fibers, braids, interwoven or non-interwoven. Coatings may be metallic, ceramic, polymeric or combinations thereof. Suitable metallic coatings include titanium, TiN, tantalum, gold, platinum and their alloys. Suitable ceramic and inorganic coatings include titanium dioxide, hydroxyapatite, CaP, etc. Suitable polymeric coatings include fluoropolymers, such as PTFE, PFA, FEP, ECTFE, ETFE, parylene, polyester, PET, polypropylene, polyurethane, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphocholine, THV, etc. Suitable biodegradable materials include polylactic acid, polyglycolic acid, polydioxanone, polycaprolactone, polyanhydride, polyorthoester, coether ester, polyamide, polylactone, polypropylene fumarate and combinations thereof. Such metallic, ceramic and / or polymeric coatings are listed only as examples. Any suitable metal, ceramic, polymer, or combination thereof can be used to produce the desired coating.

[0327] All references mentioned herein are incorporated herein in their entirety, and it is understood by those skilled in the art, in the spirit of this disclosure, that any of these referenced devices or methods may be used, in whole or in part, or in combination with other referenced devices, in whole or in part, or with innovative modifications.

Claims

1. A method for implanting an aortic heart valve, the method comprising: a. Deploy one or more temporary valves within the patient's aorta; b. Once the temporary valve is in place, establish a blood pathway to supply the patient's coronary arteries; c. Implanting a prosthetic valve within the patient's aorta, the prosthetic valve comprising an actuator arm and / or a clamp; as well as d. Actuate the actuating arm of the prosthetic valve independently or simultaneously to securely grasp the patient's aortic valve leaflet.

2. The method according to claim 1, further comprising: a. Deploy temporary valves above and below the original heart valves; b. Establish a flow path between the two temporary valves, thereby creating a bloodless space at the original valve; c. Establishing continuous optical cleaning fluid rinsing within the space; and d. Use an optical camera to visualize the aortic valve region to assist in the procedure.

3. The method according to claim 2, further comprising: a. Use a heart pump to assist flow between the two temporary valves.

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

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

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

7. The method of claim 1, further comprising: a. The prosthetic valve is implanted at the level of the native aortic leaflet and below the coronary ostium.

8. The method of claim 1, further comprising: a. Implant the prosthetic valve above / downstream of the native aortic leaflet and above / downstream of the coronary ostium; as well as b. Establish flow to the coronary arteries.

9. The method of claim 1, further comprising: a. Deploy one or more temporary filters within the patient's aorta.

10. The method of claim 1, further comprising: a. Implantation of the prosthetic valve device, the prosthetic valve device comprising a frame with an actuable arm and modular insertable and replaceable prosthetic leaflets, the modular insertable and replaceable prosthetic leaflets being capable of being removed and replaced at a later date postoperatively.

11. The method of claim 1, further comprising: a. Implant a prosthetic valve with a frame that has better compliance to reduce trauma and maintain normal tissue compliance.

12. The method of claim 1, further comprising deploying the prosthetic valve with an actuating arm to be fixed against the native valve wall, annulus, or leaflet.

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

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

15. The method of claim 1, further comprising a deployment system wherein the diseased native leaflet and the stenotic native leaflet are cut to make room for a new valve in the valve prosthesis device.

16. An apparatus comprising a prosthetic valve having an actuable arm capable of sequentially or simultaneously actuating to reversibly and repeatedly grasp the native leaflet, while the prosthetic valve is in a fully expanded state.

17. An aortic prosthesis device with an attached leaflet grasping arm, the leaflet grasping arm comprising a superelastic material such as nitinol or a combination of metal, plastic, ceramic, or a combination thereof, and a lever arm for mechanical advantage, the lever arm being attachable to a prosthesis valve using components such as sutures, hinges, welds, adhesives, screws, or rivets. The arm may have barbs or other friction elements to securely grasp the leaflets. If necessary, the device is repositionable, redeployable, or removable by actuating the arm.

18. The aortic prosthesis device according to any one of the preceding claims, wherein the prosthesis valve is capable of being repositioned, deployed, and evaluated multiple times in its fully expanded state.

19. The aortic prosthesis device according to any of the preceding claims, wherein the arm is a plurality of components configured to be biased toward each other at its base or anywhere between the arm and the device, allowing the arm to be lifted or rotated using components such as sutures, screw mechanisms, hydraulic, electrical, chemical, pneumatic, etc.

20. A replaceable prosthetic leaflet device comprising a valve housing with fixation / attachment elements for removable attachment to elements such as a frame, arm, and skirt that can be held in place to the surrounding tissue after implantation.

21. The replaceable prosthetic leaflet design according to any one of claims, wherein the skirt is hollow, balloon, covered stent or any covered structure, expandable and compressible structure, perforated structure, fabric, braid, film, coating, membrane pad, sponge, sponge-like structure or any structure capable of preventing blood leakage.

22. The replaceable prosthetic leaflet design according to any one of claims, wherein one or more retrievable elements, such as suture coils, hooks, magnets, sutures, or any generally known element that facilitates retrieval of the device after implantation (see the co-owned patent for additional details). The retrievable element may also be actuable, deployable, or remotely triggerable.

23. The replaceable prosthetic leaflet design according to any one of claims, wherein a retrievable element is placed on both the replaceable valve and the valve housing, such that the element on the replaceable valve is used for disassembly, removal and replacement of the valve housing including stabilizers such as the pins, hooks or slots.

24. The replaceable prosthetic valve system according to any one of claims, wherein the leaflets are designed / configured to be tearable valve leaflets and / or optionally housed in a secondary frame for easy removal (similar to a modular or cassette design). Once removed, the new secondary frame with the new valve can be fitted inside the permanent prosthetic valve frame.

25. The replaceable prosthetic leaflet design according to any one of claims, wherein the replaceable valve has a retrievable element for pulling the failed leaflet out of the slot in the valve housing. The new replaceable valve can then be press-fitted into the valve housing using a balloon. Once secured, the balloon is removed.

26. The replaceable prosthetic leaflet design according to any one of the claims, wherein the replaceable valve has a snap-fit ​​assembly, an elastic assembly, a hyperelastic assembly, a screw-on assembly, and / or a screw assembly.

27. The replaceable prosthetic leaflet design according to any one of the claims, wherein the replaceable valve can be reversibly fixed or removed using ultrasound, laser, heat, UV, adhesive, friction, tapered / pin assembly and / or mechanical assembly.

28. The replaceable prosthetic leaflet design according to any one of claims, wherein a spacer is used to alleviate regurgitation.

29. The replaceable prosthetic leaflet design according to any one of claims, wherein the shape and cross-section can be any geometry, including cylindrical, star-shaped, triangular, flat, crescent-shaped, elliptical, etc. Further, the spacer can be expandable, compressible, stretchable, inflatable, porous, solid, linear, or sponge-like.

30. The replaceable prosthetic leaflet design according to any one of claims, wherein the cover plate, leaflet, or disc is used to alleviate regurgitation.

31. The replaceable prosthetic leaflet design according to any one of claims, wherein the cover can be flexible, rigid, stretchable, non-stretchable, hollow, balloon, covered stent or any covered structure, expandable and compressible structure, perforated structure, fabric, braid, film, mesh, fiber, coated, membrane pad, sponge, sponge-like structure or any structure that can relieve valvular regurgitation when placed over the gap between the leaflets.

32. The replaceable prosthetic leaflet design according to any one of the claims, wherein the cover can be made of any combination of metal, plastic, biological, non-biological, ceramic, hyperelastic, shape memory, composite, fabric, woven, machined, 3D printed or POSA known.

33. The replaceable prosthetic leaflet design according to any one of claims, wherein the cover can include at least one structure, two structures, or three or more structures. The cover can have a single leaflet cover, a double leaflet cover, or three or more leaflet covers.

34. The replaceable prosthetic leaflet design according to any one of claims, wherein the cover can be of any shape, such as circular, pizza-shaped, triangular, trapezoidal, square, elliptical, etc. The cover can be corrugated, folded, smooth, fan-shaped blade structure, Japanese-style foldable fan structure, with or without any slits. The cover can have elements, reinforcing members, lines, or sheets along the edges and sides to configure and optimize the shape during diastole (to minimize reflux) and systole (to maximize blood flow).

35. The replaceable prosthetic leaflet design according to any one of claims, wherein the mechanical prosthetic valve includes a coating, fabric, or braid that promotes tissue encapsulation and endothelialization of the leaflet and valve body to alleviate the need for anticoagulants.

36. The replaceable prosthetic valve design according to any one of claims, wherein the mechanical prosthetic valve includes a rubber-like soft seal to mitigate clicking noise during valve opening and closing. The soft seal is achieved using a polymer O-ring, a base, tissue growth, or a fabric membrane pad.

37. The replaceable prosthetic leaflet design according to any one of the claims, wherein the mechanical prosthetic valve uses polymer leaflets instead of metal leaflets, for example, polypropylene using polyurethane leaflets.

38. The replaceable prosthetic leaflet design according to any one of the claims, wherein the prosthetic mechanical valve comprises a single-piece structure leaflet that bends / flexes to open or close, rather than the hinged type found in typical mechanical valves, and two or more leaflets.

39. The replaceable prosthetic leaflet design according to any one of claims, wherein the prosthetic mechanical valve comprises a 3D-printed composite leaflet designed to mitigate the required action of anticoagulants and click noise. The 3D-printed composite leaflet will have a cushioning base when closed.

40. The replaceable prosthetic valve design according to any one of claims, wherein a filter comprising a mesh and a self-sealing or sealable port for advancing various catheters can be placed downstream of the coronary sinus, in which case a tube can be used to supply fragment-free blood to the coronary artery. The sealing of the blood flow to the coronary artery is achieved using conventionally known methods including tight-fitting tubes, tapered tubes, inflatable or sponge cuffs, stents, O-rings, etc.

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

42. The prosthetic device with said spacers according to any one of claims, wherein said spacers are intelligent and said shape is remotely altered electronically, hydraulically, mechanically, or chemically, but is not limited to these examples.

43. The prosthetic device with a recyclable component according to any one of claims, wherein it optionally has features that facilitate detection, such as radiopaque, echogenic, magnetic, fluorescent, etc., and wherein said component can be polymeric, metallic, ceramic, nitinol, etc.

44. A method of using the temporary valve according to any one of the claims, wherein the temporary valve is switchable between bidirectional valves (flowing in both directions).

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

46. ​​The method of using the temporary valve claimed in any of the preceding claims, wherein a temporary one-way valve is placed upstream of the valve such that blood flow to the coronary artery is not affected if a failed prosthetic valve needs to be removed or the prosthetic valve leaflets need to be cut.

47. The method of using the temporary valve according to any one of claims, wherein a cuff, which may be a balloon, hemispherical, concave, cup-shaped, bowl-shaped, expandable umbrella-shaped structure, disc, stent, or any other component, is configured to restrict blood flow upon deployment.

48. The method of using the temporary valve and cuff as seen in any one of the claims, wherein the cuff has a port for flushing the working area around the failed valve with a clear, semi-transparent, or transparent liquid, such as heparinized saline, to aid visualization using a camera or optical technique.

49. A ring tightening device, wherein a support is designed from a tube laser-cut, used as a compression spring with a typical circular cross-section, and fastened, welded, stitched, or interlaced, wherein the ring can pass through the compression spring and be compressed by tightening the rope, wherein the ring is made of a compression spring with a typical circular profile, a support with a compression spring, a flattened compression spring with an elliptical, rectangular, triangular, trapezoidal, C-shaped, S-shaped, or any other suitable profile, and wherein the compressible spring can be made from wire, sheet, tube, or 3D printed. It can have a typical support, be braided, interlaced, coiled, or any suitable device.

50. The annular tightening device according to any one of claims, wherein the ring comprises barbs or other friction elements with a depth of less than 2 mm, 1.5 mm, 1 mm, 0.5 mm, 0.25 mm, 0.1 mm and / or 0.001 mm, for non-traumatic engagement with tissue and / or minimal trauma to said tissue.

51. A method of deploying the prosthetic valve according to any one of claims, wherein a left ventricular assist device (LVAD) or a heart pump is used to unload the pressure across the aortic heart valve during the procedure.

52. A method of annular repair, wherein the device is deployed non-invasively around the valve annulus, and the device is tightened at a later date after tissue encapsulation to tighten the valve annulus and thereby relieve regurgitation.

53. An implantable medical device for insertion into the left atrial appendage of a patient, comprising: a. A highly compliant frame placed behind the valve ring; as well as b. A cover configured to cover at least a portion of the frame to prevent blood from passing through the frame and reduce bare metal exposure to circulating blood.

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

55. An implantable medical device for insertion into the left atrial appendage of a patient as claimed in any of the preceding claims, wherein the device includes additional components selected from defibrillators, stimulators, sensors, transducers, drug delivery systems, patient monitoring systems, or remotely operable smart devices, the device being capable of wired and wireless operation.

56. An implantable medical device for insertion into a patient's left atrial appendage, comprising a one-way valve that allows fluid to enter the cavity sealed at the distal end of the left atrial appendage.

57. A method of implanting a medical device for insertion into the left atrial appendage according to any one of claims, wherein the additional step comprises: The LAA was perfused with physiological saline for visualization using a camera; Alternatively, a temporary seal may be used to close the implantation area to isolate blood flow and perfuse with saline solution for visualization and inspection of leaks.

58. An occlusion device / method implanted within the LAA (behind the orifice / valve annulus), configured to maximize preservation of LAA function while minimizing the risk of thrombosis.

59. The method of implanting an occlusion device inside the LAA (behind the orifice / valve annulus) is configured to maximize preservation of LAA function while minimizing the risk of thrombosis.

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

61. The method according to any one of claims, wherein, before, during and / or after surgery, evaluation software simulations (fluid dynamics, structural analysis and / or artificial intelligence) are performed to determine the correct depth, position, size and / or shape of the device.

62. The method of any one of claims, wherein optical, visual, echo, fluorescence, ICE guidance is used for implantation, and determining the correct depth, position, size, and shape of the device is assessed preoperatively, during surgery, and postoperatively.

63. The method according to any one of the claims, wherein some or all of the LAAs are isolated from the blood supply, flushed with saline, and the LAAs are visually examined to determine the correct implantation depth, location, and device size and shape of the assessment before, during, and after the procedure.

64. The method according to any one of claims, wherein the occlusion device is a single body / segment comprising a stent, sponge, gel, saline, air, biodegradable, bioabsorbable, metallic, polymeric, organic, inorganic, elastic, plastic, hyperelastic, shape memory, balloon, bellows, 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 thereof (e.g., the Watchman device).

65. The method of any one of claims, wherein the left atrial occlusion device comprises two or more bodies / segments comprising a stent, sponge, gel, saline, air, biodegradable, bioabsorbable, metallic, polymeric, organic, inorganic, elastic, plastic, hyperelastic, shape memory, balloon, bellows, diaphragm, porous structure, cone, umbrella structure, disc, 3D printed, compliant, semi-compliant, check valve, bidirectional valve, non-compliant, covered, coated, bare, or any combination thereof (e.g., Abbott amulet device).

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

67. A method for selecting and pre-planning the implantation of a LAA device, wherein a combination of FEA, artificial intelligence, and / or fluid dynamics is used to determine the size, shape, features, and placement depth, and the procedure is performed to maximize LAA functionality and / or minimize the risks of thromboembolism, arrhythmia, paravalvular leak, and / or tissue trauma.

68. An apparatus or method for occluding the left atrial appendage (LAA) as referred to in any of the preceding claims, wherein the apparatus or method is inspired by, but not limited to, the design of occlusion devices such as Watchman and Amulet, is configured to completely occlude the LAA at the orifice, and is further configured to be located distal to the orifice of the LAA within the LAA, the method or apparatus being configured to maximize LAA functionality and minimize the risk of complications selected from thromboembolism, arrhythmia, paravalvular leak, and tissue trauma.

69. A method or apparatus as claimed in any of the preceding claims, comprising an occlusion device, wherein the occlusion device comprises one or more components selected from gels, sponges, pumps, sensors, transducers, and drug delivery systems, the components being located inside the occlusion device or in the distal left atrial appendage (LAA) pocket of the LAA device or outside the atrium, ventricle, or LAA.

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

71. An embolism protection device comprising a sealing ring, a flexible, bendable, and / or foldable filter, and a conduit, wherein: a. The sealing ring is expandable to seal against the lumen of the blood vessel. b. The filter is attached to the sealing ring and the distal section of the conduit. c. The catheter allows access to the device delivery system. d. Without affecting the ring's ability to seal or capture the plug, the filter allows relative movement between the conduit and the ring, and e. It is capable of tightening or closing the sealing ring to trap the plug and retrieving the system together with the plug from the body.

72. The embolic filter according to any combination of claims, wherein there are one or more sealing rings and one or more filters between each of the rings to allow the rings to expand or tighten simultaneously or sequentially, and to trap the embolus and recover or remove the embolus together with the catheter.

73. The embolization filter according to any combination of claims, wherein the catheter is advanced near or distal to one or more sealing rings to allow the implant to pass through without affecting the seal.

74. The embolization filter according to any combination of claims, wherein the embolization filter is modified for use in the carotid artery, central and / or peripheral artery or vein.

75. An embolism filter as claimed in any of the preceding claims, further described in the detailed embodiments, and illustrated in the figures of this disclosure.

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

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

78. The embolism protection device according to any combination of claims, wherein the filter material is supported by a wire or shape memory support element.

79. The embolism protection device according to any combination of claims, wherein a separate lumen is added to deliver a coagulant or an anticoagulant such as heparin.

80. The embolism protection device according to any combination of claims, further comprising a suction device for real-time removal of debris, with or without visual / optical guidance.

81. The embolism protection device having multiple seals, wherein each seal is tightened sequentially to reduce the risk of lost fragments and removal of the device.

82. The embolism protection device having a plurality of sealing points with the vessel wall and a filter between the seals, wherein the filter has a shape memory or smaller diameter coil to limit contact with the vessel wall to mitigate the trauma of embolic eruption.

83. A method for embolism protection in the aortic arch, comprising the following steps: A device is provided comprising proximal and distal seals with an extended shaft and a filter body with one or more seals at the distal opening of the shaft on the artery; a filter comprising a flexible mesh for trapping embolic fragments; a guidewire for advancing the device into the aortic arch using a dilator; deployment of the filter, wherein the distal end of the filter is between the aortic valve and the brachiocephalic artery (ascending aorta); and the filter is constrained by one or more radially expanding seals.

84. The embolism protection device / method according to any one of claims, wherein the nearest seal moves past the intermediate seal and the farthest seal to move the filter catheter shaft closer to the implantation site.

85. The embolism protection device / method according to any one of claims, wherein if blood is flowing in the opposite direction, the seal moves through the folds created by each other to capture embolism fragments.

86. The embolism protection device / method according to any one of claims, wherein an expandable Z-shaped bracket is used near the distal opening to create a seal.

87. The embolism protection device according to all claims, wherein the support is cylindrical, conical, or windshield-shaped and housed in a sheath.

88. The embolism protection device according to any one of the preceding claims, wherein the filter conduit comprising the sheath is steerable.

89. An embolism protection device according to any one of the figures.

90. An embolism protection device according to FIG21B includes an expandable seal 310, a conical filter 300, and a catheter shaft 314, wherein the conical filter restricts unnecessary contact with the aortic wall.

91. An embolism protection method as shown in Figures 22A to 26C includes the following steps: a. Guide the guidewire to the desired location. b. Advance the embolic filter catheter 314 over the guidewire. c. Deploy the filter by extending the expander 320 out of the conduit. d. A seal is created at the distal end of the filter via the expandable ring 310, such that the seal is maintained even if the conduit 314 moves relative to the filter. e. Remove the dilator 320 to create space for the insertion of the delivery device conduit 316. f. Performing surgery using the delivery device, wherein any released debris is captured by the filter. g. Remove the delivery device conduit 316. h. Tighten the ring 310 to securely contain all fragments, and i. Remove the embolized filter catheter from the patient.

92. A catheter in which an ultrasound imaging probe can be assembled inside the body to increase the total area of ​​the transducer array.

93. A conduit that uses magnets, sutures, nitinol moldings and / or cables to reversibly assemble the transducer outside the conduit.

94. A catheter that houses an ultrasound imaging probe, partially outside the catheter and partially inside the catheter.

95. A surgical procedure that uses two or more catheters to produce improved imaging synchronously, asynchronously, sequentially or simultaneously, in pulsed or continuous form or any combination thereof (both acting as transmitters and receivers).

96. An ultrasonic imaging probe that images in transmission, reflection, backscattering, or emission modes. Note: Emission occurs when ultrasound is generated outside the probe, for example, through bubble cavitation.

97. An ultrasonic imaging probe, said ultrasonic imaging probe imaging in harmonic mode, subharmonic mode and superharmonic mode.

98. An ultrasound imaging probe as claimed in any of the preceding claims, the ultrasound imaging probe being configured to perform imaging at a set of frequencies, the set of frequencies being integer multiples or fractional multiples of the emission frequency, wherein the set of integer multiples includes, but is not limited to, 1x, 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 claimed in any of the preceding claims, the ultrasound imaging probe being configured to operate in a nonlinear ultrasound imaging mode.

100. A catheter in which more than one probe is reversibly assembled using sutures or threads, wherein the assembled probe is much larger than the diameter of the catheter.

101. A catheter comprising a series of probes and a flexible connector inside the catheter to allow for catheter flexibility while allowing for an increased surface area.

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

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

104. A delivery catheter according to any combination of claims, wherein the distal portion is configured to extend straight even when traversing a tortuous curve.

105. A delivery catheter according to any combination of claims, wherein the delivery catheter comprises a multi-lumen shaft or a plurality of single-lumen shafts.

106. A delivery catheter according to any combination of claims, wherein the shaft is made of metal, plastic, glass, ceramic, organic, inorganic, coated, uncoated, lubricated, antibacterial, PI, PEBAX, nylon, nitinol, or any biocompatible material or combination thereof.

107. The delivery catheter according to any combination of claims, wherein the delivery catheter can be configured to have a bending radius ranging from 0.1 mm to 10,000 mm and between therewith, preferably having a radius of about 9 mm in the distal segment and a radius of about 42 mm in the proximal segment.

108. The delivery catheter according to any combination of claims, wherein the delivery catheter can be configured to have a compressive resistance in the range of 0.1 lbf to 10,000 lbf and between therewith, preferably a force of 6 lbf, resulting in a shortening in the range of 10 mm to 0.0001 mm, preferably ~0.1 mm.

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

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

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

112. A delivery catheter for treating the mitral valve, tricuspid valve, pulmonary valve, aortic valve, LAA, blood vessel, organ, tissue or GI tract as described in any combination of claims.

113. A delivery catheter according to any combination of claims, the delivery catheter comprising a chamber / segment capable of moving in a lumen or surface using a peristaltic motion, either with or without bristles (using friction).

114. A delivery catheter according to any combination of claims, the delivery catheter comprising a chamber capable of elongation, rotation, contraction, bending, folding, movement, pushing, and pulling.

115. One or more chambers, said chamber or chambers being capable of being used for remote treatment or diagnosis.

116. A delivery catheter chamber capable of use in vivo, ex vivo, outside the body, on a workbench, inside other machines, devices, or robots.

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

118. Any combination of the disclosed concepts, wherein the conduit shaft comprises any, all or any combination of a piston, balloon, cable, nitinol motor, gear, cam or sensor placed outside, inside or in the wall of the shaft, configured to manually, remotely, robotically or using a program or AI to lengthen, rotate, shorten, pull, push, expand, mate or organize.

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

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

121. The method of maximizing isolation of the middle section of a multi-segment steerable conduit by using mechanical advantages (pulley system) in the pull wire.

122. A delivery catheter device or method as 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 each other; b. A coupler coupled to the arm and configured to move relative to the arm; And a plurality of anchors configured to facilitate tissue encapsulation, wherein the distal portion of each of the arms carries and is configured to engage tissue at or near the annulus. c. and a tightening band coupled to the anchor; wherein when the device is in a deployment configuration such that the arm extends axially and radially away from the coupler, and the tightening band is configured to initially allow sufficient time for the organization and encapsulation of the anchor.

124. An apparatus according to any one of claims, wherein the coupler is configured to translate and / or rotate relative to the arm.

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

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

127. An apparatus according to any one of claims, wherein when the arm is in a deployment configuration, movement of the coupler relative to the arm reduces the angle between adjacent arms.

128. An apparatus according to any one of claims, wherein the plurality of arms comprises at least three arms.

129. A device according to any one of claims, wherein each of the anchors is detachably coupled to one of the arms such that, after treatment, the coupler and the arm are removed from the patient, leaving only the anchor implanted at the valve annulus.

130. An apparatus according to any one of claims, wherein each of the anchors is attached to a single arm.

131. The apparatus according to any one of claims, further comprising a stitch coupled to the anchor.

132. A device according to any one of claims, wherein the valve annulus is a cardiac valve annulus, and wherein the device is configured to be close to and percutaneously delivered above the valve annulus, such that the anchor is implanted in the annular cardiac tissue directly above the plane of the valve foramen.

133. A device for treating a native valve annulus, the device comprising: d. A plurality of arms, each of the plurality of arms 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 proximate to the coupler and a second length distal to the coupler. f. And wherein the distal portion of each of the arms is not coupled to the other of the arms, such that the second length of the arm extends from the coupler cantilever; g. and a plurality of anchors configured to facilitate tissue encapsulation, each of the distal portions of one of the arms carrying and configured to engage tissue at or near the annulus, wherein when the device is in a deployment configuration such that the second length of the arm extends axially and radially away from the coupler, movement of the coupler relative to the arm reduces the circumferential distance between at least some of the anchors.

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

135. An apparatus according to any one of claims, wherein the coupler is configured to translate and / or rotate relative to the arm.

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

137. An apparatus according to any one of claims, wherein when the arm is in a deployment configuration, movement of the coupler relative to the arm reduces the angle between adjacent arms.

138. An apparatus according to any one of claims, wherein the plurality of arms comprises at least three arms.

139. A device according to any one of claims, wherein each of the anchors is detachably coupled to one of the arms, such that after treatment, the coupler and the arm are removed from the patient, leaving the anchor implanted at the valve annulus.

140. An apparatus according to any one of claims, wherein the movement of the coupler relative to the arm reduces the circumferential distance between at least some of the anchors.

141. An apparatus according to any one of claims, wherein the movement of the coupler relative to the arm increases the circumferential distance between at least some of the anchors.

142. The apparatus according to any one of the claims, wherein the tightening band is capable of tightening (or expanding) at multiple time points (subsequent surgery) to progressively reduce (or increase) its diameter.

143. An apparatus according to any one of claims, wherein the tightening band can be configured to be replaced to tighten (or expand) at multiple time points (subsequent surgeries) to progressively reduce (or increase) the diameter.

144. A device according to any one of claims, wherein the tightening band is biodegradable, bioabsorbable, or biosoluble, wherein the biodegradable, bioabsorbable, or biosoluble band applies a tightening (or expansion) force or the anchor or device or tightening band after implantation (or tissue encapsulation or tissue adhesion) for a set time (30 days, 60 days, 90 days, 120 days, 180 days, 270 days, 360 days, or 720 days) to gradually reduce (or increase) the diameter.

145. A device according to any one of claims, wherein the anchor or non-invasive anchor has a fabric or woven polymer cover or surface coating that promotes tissue encapsulation / adhesion.

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 each other; i. A coupler, said coupler being coupled to the arm and configured to move relative to the arm; as well as j. A plurality of anchors, each of which is carried and configured to engage tissue at or near the annulus, a delayed-response suture or scaffold interacting with one or more anchors, wherein when the device is in a deployment configuration such that the arm extends axially and radially away from the coupler, and optionally, movement of the coupler relative to the arm reduces the circumferential distance between at least some of the anchors, and the delayed-response suture or scaffold changes over time from a stretched configuration during implantation to a tightened configuration after implantation.

147. An apparatus according to any one of claims, wherein the tightening delay time is 15 days, 30 days, 60 days, 90 days, 120 days or up to 3 years.

148. A device according to any one of 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 according to any one of claims, wherein each of the anchors is detachably coupled to one of the arms such that, upon completion of treatment, the coupler and the arm are removed from the patient, leaving the anchors, together with the delayed tightening suture / stent, implanted at the valve annulus.

150. A leaflet repair device or any of the claims, the leaflet repair device comprising at least one leaflet reinforcement member that pulsates (or oscillates) together with the original leaflet, configured to prevent valve regurgitation.

151. A leaflet repair device or any of the claims, said leaflet repair device being paired with a valve annulus engagement bracket, wherein said valve annulus engagement bracket supports the oscillating / pulsating leaflet.

152. A leaflet repair device or any of the claims, wherein the leaflet reinforcement is expandable, expansive, compressible, steerable, bendable and / or oriented.

153. A leaflet repair device or any of the claims, wherein the annulus valve engagement is automatically tightened or manually tightened shortly after surgery, after a sufficient period of permissible tissue encapsulation.

154. A leaflet repair device or any of the claims, wherein the leaflet reinforcement is automatically or manually configured at a later time after surgery (after sufficient time for permissible tissue encapsulation) to prevent valve regurgitation.

155. A prosthetic valve according to any combination of claims, comprising an annular stent and a leaflet reinforcement, wherein the leaflet reinforcement pulsates / oscillates to open and close, is configured to prevent backflow when closed and is configured to allow maximum opening of the orifice.

156. A prosthetic valve according to any combination of claims, wherein, similar to the native leaflet of an aortic valve, the prosthetic leaflet is located at the level of the prosthetic valve annulus and below the prosthetic valve annulus. Optionally, the prosthetic leaflet is capable of being above the prosthetic valve annulus. Optionally, the prosthetic leaflet is attached only to the prosthetic valve annulus, mimicking a native valve attached only to the native valve annulus. Optionally, the leaflet is within and protrudes from the prosthetic valve annulus.

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

158. A prosthetic valve according to any combination of claims, wherein the prosthetic valve has an actuable grasping arm for securing the prosthetic valve using native leaflets.

159. A prosthetic valve according to any combination of claims, wherein the prosthetic valve has an actuable grasping holder for securing the prosthetic valve using native leaflets.

160. A prosthetic valve according to any combination of claims, wherein the prosthetic valve has an actuable grasping arm and a clamp to secure the prosthetic valve along both sides of the native leaflet.

161. A prosthetic valve according to any combination of claims, wherein the prosthetic valve has an actuable grasping arm / gripper for securing the prosthetic valve using a native aortic valve annulus or wall.

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

163. A prosthetic valve according to any combination of claims, wherein the annular stent is retractable before, during, or after surgery, and has a native leaflet reinforcement / support that punctures through a small hole in the native leaflet from the atrial side and expands in the ventricular side.

164. A prosthetic valve according to any combination of claims, comprising an annular support structure, leaflets attached to the annular support structure, and tissue grasping or fixing elements attached to the annular support structure.

165. A prosthetic valve according to any combination of claims, wherein the prosthetic leaflet is primarily below the annular support structure.

166. A prosthetic valve according to any combination of claims, wherein the prosthetic leaflet is primarily above the annular support structure.

167. A calcium enhancement device according to any one of claims, the calcium enhancement device comprising an energy generator and an energy transfer element, configured to enhance ions or minerals in the body.

168. A calcium enhancement device according to any one of claims, wherein the energy generator is an electromagnetic waveform / eddy current / magnetic field generator.

169. A calcium enhancement device according to any one of claims, wherein the energy transfer element comprises at least an electrode, a coil, a magnet, or a combination thereof.

170. A calcium-enhancing device according to any one of claims, wherein the calcium-enhancing device is configured to alleviate calcium deposition in the blood vessels, kidneys, and organs.

171. A calcium-enhancing device according to any one of claims, wherein the calcium-enhancing device is configured to improve the absorption of minerals by tissues and organs.

172. A calcium enhancement device according to any one of claims, the calcium enhancement device comprising exemplary technologies such as iSpring ED2000, Yarna CWD24, Calmat, ScaleBlaster, and Eddy to improve the absorption, reabsorption, and precipitation of minerals.

173. A calcium enhancement device according to any one of claims, wherein the EMP is applied transdermally or subcutaneously across any region of the body, organ, or tissue, externally, internally, implantably, wirelessly, or wiredly.

174. An optical visualization device / method according to any one of claims, comprising a catheter-based balloon filled with clear fluid or gas or saline and carrying a camera mounted on an internal tubing.

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

176. A catheter-based balloon comprising a shock wave generator (SWG) filled with clear fluid; and an internal balloon having a camera mounted on a steerable shaft inside the balloon.

177. A shock wave generating device / method, comprising: One or more shock wave generators, a camera 2010 housed within a gas-filled balloon 2050, a steerable shaft for turning the camera 2030, a reflector / focusing balloon 1960, a clear fluid-filled balloon 2015 housing the shock wave generator and camera, and a reflective balloon, wherein the reflective balloon 2050 is positioned around the shock wave generator to focus on the treatment site, and the optical camera 2010 is used to provide optical guidance for delivering the treatment.

178. A shock wave generating apparatus / method according to any one of claims, wherein the reflective balloon 2050, the camera 2010, and any other embodiment inside the balloon 2015 are supported by stitches, braids, altered viscosity, or any other known means to stabilize them when necessary and required during use.

179. An optical visualization device / method according to any one of claims, wherein the balloon includes a sealable port through which a robotic catheter intervention device catheter, a steerable camera shaft, and a camera can be advanced outside the balloon for desired intervention.

180. An optical visualization device / method according to any one of claims, comprising one or more collapsible, self-opening umbrella-shaped seals, said one or more collapsible, self-opening umbrella-shaped seals being used to shunt blood flow and in conjunction with a saline pump to produce a transparent optical medium.

181. An optical visualization apparatus / method according to any combination of the figures and any one of the claims.

182. An optical visualization device / method according to any combination of the descriptions in the specification, as claimed in any one of the claims.

183. An optical visualization apparatus / method according to any combination of the description and any combination of the figures in the specification, as described in any one of the claims.

184. An apparatus as described in any configuration of this entire application.

185. An apparatus as described in any one of the figures or a combination thereof.

186. An apparatus as described herein by any method and / or combination of methods.

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

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

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