JP2024019679A - Tissue grasping devices and related methods - Google Patents

Abstract

The present invention provides suitable tissue grasping devices and related methods. A clip for securing a leaflet of a heart or venous valve includes a pair of tangle-resistant spring-loaded outer arms coupled to a lower end of a hub, and adjacent to the outer arms and coupled to an upper end of the hub. a hub having a pair of tangle-resistant spring-loaded inner arms; A delivery catheter may be used to position the valve clip adjacent the target valve while the outer and inner arms are biased in an open position relative to each other. After the leaflet is positioned between the open outer and inner arms, the biasing force may be released allowing the clip to self-close over the leaflet. [Selection diagram] Figure 2B

Description

(Citation of related application)
This application claims the benefit of U.S. Provisional Application No. 62/361,953, filed July 13, 2016, Attorney Case No. 52206-703.101, the entire contents of which are hereby incorporated by reference. Quoted in

(Background of the invention)
(1. Field of invention)
TECHNICAL FIELD The present invention relates generally to medical methods, devices, and systems. In particular, the present invention relates to methods, devices, and systems for endovascular, percutaneous, or minimally invasive surgical treatment of body tissue, such as tissue access or valve repair. More specifically, the present invention relates to methods and devices for repair of mitral and tricuspid heart valves, venous valves, and other tissue structures through minimally invasive and other procedures.

Surgical repair of body tissue often involves tissue approximation and cerclage of such tissue in an approximate arrangement. When repairing a valve, tissue access often involves coapting the leaflets of the valve in a therapeutic alignment, which can then be maintained by fastening or fixating the leaflets. Such fixation of the leaflets can be used to treat regurgitation, which most commonly occurs in the mitral valve.

Mitral regurgitation is characterized by backflow of blood from the left ventricle of the heart through a dysfunctional mitral valve and into the left atrium. During the normal cycle of heart contraction (systole), the mitral valve acts as a check valve to prevent flow of oxygenated blood back into the left atrium. In this way, oxygenated blood is pumped through the aortic valve and into the aorta. Valve regurgitation can significantly reduce the pumping efficiency of the heart and put patients at risk for severe progressive heart failure.

Mitral regurgitation can result from several different mechanical defects in the mitral valve or left ventricular wall. The valve leaflets, the valve tendons that connect the leaflets to the papillary muscles, the papillary muscles themselves, or the left ventricular wall may become damaged or otherwise dysfunctional. Generally, the annulus can become damaged, dilated, or weakened, limiting the mitral valve's ability to properly close against the high pressures of the left ventricle during systole.

The most common treatments for mitral valve regurgitation rely on valve replacement or valve repair, including leaflet and annulus remodeling, the latter generally referred to as valvuloplasty. One technique for mitral valve repair that relies on suturing together adjacent segments of opposing leaflets is referred to as the "bowtie" or "incisal" technique. While all these techniques can be effective, they typically rely on open-heart surgery, where the patient's chest is opened, typically through a sternotomy, and the patient undergoes cardiopulmonary bypass. do. The need to both open the chest and bypass the patient is traumatic and associated with high mortality and morbidity.

In some patients, a fixation device can be placed within the heart using minimally invasive techniques. The fixation device can hold adjacent segments of opposing leaflets together to reduce mitral regurgitation. One such device used to clip together the anterior and posterior leaflets of the mitral valve is the MitraClip® fixation device sold by Abbott Vascular (Santa Clara, California, USA). .

Fixation devices, such as the MitraClip® leaflet fixation device, often grip the valve tissue as the clip arm is moved, positioned against the tissue at the treatment site, and then closed against the tissue. and a clip designed to hold it. Such clips are designed to be closed to a final position and then mechanically locked in that position for continued gripping of tissue.

In addition, the act of grasping and closing to the final position tightens the leaflets and potentially the annulus. Considering that the MitraClip® is a relatively rigid device with mechanically locked steel (Elgiloy®) arms, the natural expansion and contraction of the annulus is modified. be done.

Furthermore, in order to achieve escape and remove or reposition the device, it is required to flex the device at an extreme angle (to the point of reversal) and release the grip. This extreme movement and deformation of the components of the fixation device during pre-deployment, positioning, closure, and evacuation of the device can lead to weakening and premature deterioration of the fixation device. In addition, this makes the device extremely complex with multiple components and contributes to a relatively large overall size of the device and therefore a correspondingly large (approximately 24 Fr for the MitraClip® fixation device) delivery Contribute to the system. This larger catheter size presents additional trauma to the patient. By comparison, typical transseptal introducer sheaths are 8.5Fr to 12Fr (inner diameter) and 9Fr to 16Fr (outer diameter).

Some tissue fixation procedures require that the fixation device maintain some degree of flexibility and mobility, even after the device has been properly deployed and the target tissue has been properly fixed in the desired location, allowing for a range of require physiological movement. This risks premature failure of the device's complex locking mechanism, as continued deformation of the flexing components (e.g. from successive opening and closing of the valve leaflets) leads to unfavorable deterioration of the device. can be increased.

Depending on the valve anatomy and disease state, variations in coaptation length and dissimilarity in leaflet shape (e.g., dissimilarity between anterior and posterior mitral leaflets) generally occur. It can exist. However, current devices and the market leading MitraClip® fixation device are only offered in one size. This can pose a problem for the surgeon when presented with different valve sizes, coaptation lengths, fragility, and different functionality and degenerative valve defects to be treated.

The ability to eject and reposition is an important safety consideration for the majority of medical devices. The current market leading MitraClip® fixation device possesses these attributes to some extent as it allows for evacuation and repositioning. However, this sometimes presents a safety risk where the tissue or delivery mechanism can become stuck in the barbs of the tissue grasping feature.

Finally, visualization during and after the procedure plays an important role in successful delivery of the device and resulting outcome. Current state-of-the-art devices rely on fluoroscopy and transesophageal echocardiography (TEE). TEE primarily requires general anesthesia and adds significant risk to the elderly and frail patient population in which this type of repair procedure is typically performed.

For at least these aforementioned reasons, there remains a need to:
a) Simpler devices with fewer components: may provide the beneficial elasticity and durability of flexing components without increasing the safety and manufacturing risks associated with large numbers and complex components; Alternative and/or additional methods, devices, and systems for tissue fixation.
b) Lockless devices: The need for simpler devices to eliminate the procedural risks associated with device locking and the risks associated with failure of the locking mechanism after deployment.
c) Elastic and stretchable devices: The need for devices that gently tighten the annulus (or leaflet) while preserving some of its natural expansion and contraction.
d) Smaller catheter size/geometry: Considering that most patients undergoing these procedures may be elderly and frail due to multiple comorbidities, we created delivery devices much smaller than 24Fr, allowing for vascular access. There is also a need to reduce the risks associated with.
e) Multiple device sizes: Provide such methods, devices, and systems in a manner that does not limit the tissue grasping capabilities of the fixation device. For example, to accommodate short coaptation lengths and/or weak cusps, there may be a need for the ability to grasp beyond the coaptation area of the cusp while adapting to the shape and length of the cusp.
f) Tangle-Free Design: The current market-leading MitraClip® fixation device has barbs exposed on both sides of the tissue grasping feature. Tendons, tissues, and device delivery mechanisms can become trapped by such exposed barbs. Therefore, there is a need for improved device ejection and repositioning safety that further reduces the risk of tissue or delivery mechanism becoming stuck within the device during the procedure.
g) Visualization: There is a need for improved visualization and feedback to safely and successfully perform this procedure with little trauma to the patient.
h) Local anesthesia: The ideal procedure would be under local anesthesia without the use of general anesthesia. This reduces the higher risks associated with general anesthesia.
At least some of the embodiments disclosed below are directed to these purposes.

(2. Explanation of background technology)
Minimally invasive and percutaneous procedures for coapting and modifying mitral valve leaflets and treating mitral valve regurgitation have been described in PCT publications WO 98/35638, WO 99/00059, WO 99/01377, and WO 00/03759, WO 2000/060995, WO 2004/103162. Maisano, et al. (1998) Eur. J. Cardiothorac. Surg. 13:240-246, Fucci, et al. (1995) Eur. J. Cardiothorac. Surg. 9:621-627, and Umana, et al. (1998) Ann. Thorne. Surg. 66:1640-1646 describes an open procedure for performing an "incisal" or "bowtie" mitral valve repair in which the edges of opposing leaflets are sutured together to reduce regurgitation. . Dec and Fuster (1994) N. Engl. J. Med. 331:1564-1575 and Alvarez, et al. (1996) J. Thorne. Cardiovasc. Surg. 112:238-247 is a review article discussing the nature and treatment of dilated cardiomyopathy.

Mitral valvuloplasty has been described in the following publications: Bach and Bolling (1996) Am. J. Cardiol. 78:966-969, Kameda et al. (1996) Ann. Thorne. Surg. 61:1829-1832, Bach and Bolling (1995) Am. Heart J. 129:1165-1170, and Bolling, et al. (1995) 109:676-683. Linear segment valvuloplasty for mitral valve repair has been described by Ricchi, et al. (1997) Ann. Thorne. Surg. 63:1805-1806. Tricuspid valvuloplasty has been described by McCarthy and Cos-grove (1997) Ann. Thorne. Surg. 64:267-268, Tager, et al. (1998) Am. J. Cardiol. 81:1013-1016, and Abe, et al. (1989) Ann. Thorne. Surg. 48:670-676.

Percutaneous transluminal cardiac repair procedures have been described in Park, et al. (1978) Circulation 58:600-608, Uchida, et al. (1991) Am. Heart J. 121: 1221-1224, and Ali Khan, et al. (1991) Cathet. Cardiovasc. Diagn. 23:257-262. Endovascular heart valve replacement has been described in U.S. Pat. , 077, and 4,056,854. US Pat. No. 3,671,979 describes a catheter for temporary placement of a prosthetic heart valve.

Other percutaneous and endovascular heart repair procedures are described in U.S. Pat. No. 4,917,089, U.S. Pat. No. 91/01689.

Laparoscopic and other minimally invasive heart valve repair and replacement procedures have been described in U.S. Pat. , 797,960, 5,769,812, and 5,718,725.

MitraClip® devices, systems, and methods for engaging tissue are described in US Pat. Nos. 8,057,493 and 7,226,467.

US Patent Publication No. 2015/0257883 is particularly relevant to this application in which the principal inventor is the inventor herein.

International Publication No. 98/35638 US Patent No. 5,840,081 U.S. Patent No. 4,917,089 US Patent No. 5,855,614

(Summary of the invention)
The present invention provides devices, systems, and methods for tissue access and repair at a treatment site. The devices, systems, and methods of the invention find use in a variety of therapeutic procedures, including endovascular, minimally invasive, and invasive procedures, including abdominal, thoracic, cardiovascular, cardiac, intestinal, gastric, and urinary tract surgery. It can be used in a variety of anatomical areas, including the bladder, lungs, and other organs, blood vessels, and tissues. The present invention is particularly useful in those procedures that require minimally invasive or endovascular access to remote tissue locations, particularly those where the instruments utilized must pass through long, narrow, tortuous paths to the treatment site. . Additionally, many of the devices and systems of the present invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

In preferred embodiments, the devices, systems, and methods of the invention are adapted for fixation of tissue at a treatment site. Exemplary tissue fixation applications include heart valve repair, septal defect repair, vascular ligation and occlusion, laceration repair, and wound closure, although the present invention may find use in a wide variety of tissue access and repair procedures. In particularly preferred embodiments, the devices, systems, and methods of the invention are adapted for repair of heart valves, particularly the mitral valve, as a treatment for regurgitation. The present invention allows two or more valve leaflets to be joined using an "incisal" or "bowtie" technique to reduce regurgitation, but unlike traditional approaches, the thoracic and cardiac walls Does not require open surgery through. Additionally, the position of the leaflets may vary in affected mitral valves depending on the type and extent of the disease, such as calcification, prolapse, or flutter. These types of diseases are those in which one cusp is more mobile (e.g., more difficult to capture) than the other, and therefore more difficult to grasp symmetrically in the same grasp as the other cusp. It can bring about things. Features of the present invention enable the fixation device to be adapted to meet the challenges of unpredictable target tissue geometry, and to provide a more robust grip on the tissue once this has been acquired. Make it. Additionally, the present invention optionally incorporates visualization techniques to allow device placement procedures to be performed without the use of general anesthesia.

The devices, systems, and methods of the present invention center on various devices that can be used individually or in various combinations to form an interventional system. In a preferred embodiment, the interventional system includes a multi-catheter guidance system, a delivery catheter, and an interventional device. Each of these components will be discussed herein.

In an exemplary embodiment, the invention provides a fixation device having a pair of outer arms (or fixation elements), each outer arm having a free end and an engagement surface for engaging tissue. , the outer arm is movable between a first position for capturing tissue and a second position for securing tissue. Preferably, the engagement surfaces are spaced apart in the first position and closer together in the second position, generally facing towards each other. The fixation device is preferably delivered to the target location within the patient's body by a delivery catheter having an elongated shaft, a proximal end, and a distal end, the delivery catheter having a vascular puncture or incision or surgical penetration, etc. configured to be located at the target location from a remote access point. In a preferred embodiment, the target location is a valve within the heart.

A particular advantage of the present invention is its ability to coapt the leaflets of the mitral valve (or any other tissue for which it is used) in a parallel or perpendicular relationship. In other words, the cusps can be captured, drawn together, and secured so that their proximal upstream surfaces are arranged parallel to each other and generally aligned with the direction of flow through the valve at the junction. In some embodiments of the fixation device, the use of a sufficiently rigid outer arm, a highly frictional and compressible inner arm, and a passive closure mechanism aligns the leaflet vertically to achieve an optimal coaptation configuration. allowing the cusps to be grasped in a spaced-apart relationship and then drawn together in a coaptation relationship while keeping the cusps in a spaced relationship (aligned with blood flow).

A particular advantage of the present invention is its ability to coapt the leaflets of the mitral valve (or any other tissue for which it is used) in a parallel or perpendicular relationship while gripping in line with the anatomical contours of the leaflets. . In other words, the cusps can be captured, drawn together, and fixed, so that their proximal upstream surfaces are aligned parallel to each other while additionally grasping alongside the anatomical contours away from the symphysis. and generally aligned with the direction of flow through the valve at the junction. In some embodiments of the fixation device, the use of a fully flexible outer arm, a highly frictional and compressible inner arm, and a passive closure mechanism can be used to achieve an optimal joint configuration. Allowing the cusps to be grasped in a spaced apart relationship and then drawn together in a coaptation relationship while keeping the cusps vertical (aligned with blood flow).

A particular advantage of the present invention is to coapt the leaflets of the mitral valve (or any other tissue for which it is used) in close anatomical relation to the leaflet shape while grasping in line with the leaflet's anatomical contours. It is that ability to do. In other words, the cusps can be captured, drawn together, and fixed, so that their natural anatomical shape is retained. In some embodiments of the fixation device, the use of a fully flexible outer arm, a highly frictional and compressible inner arm, and a passive closure mechanism can be used to achieve an optimal joint configuration. allowing the cusps to be grasped in a spaced apart relationship and then drawn together in a coaptation relationship while keeping the cusps vertical (aligned with blood flow).

The fixation device is preferably delivered with an outer arm in the delivery position configured to minimize the profile of the device. When approaching the mitral valve from the atrial side, some embodiments of the fixation device allow the device to angle less than about 90°, preferably less than about 20°, to the longitudinal axis of the delivery device shaft. with the free end of the outer arm pointing in a generally proximal direction to enable delivery. In this position, the engagement surfaces generally face toward each other and are arranged at an angle of less than about 180°, preferably less than about 40°, with respect to each other. For ventricular approaches, in the delivery position, the free end of the outer arm is oriented generally distally and at an angle of less than about 90°, preferably less than about 20°, with respect to the longitudinal axis of the delivery device shaft. Form. In this position, the engagement surfaces generally face toward each other and are typically arranged at an angle of less than about 180° to each other, preferably less than about 90°. Alternatively, for some ventricular approaches, it may be preferable to have the free ends of the fixation elements facing generally proximally in the delivery location and the engagement surfaces facing away from each other.

To provide reversibility and removability of the devices and systems of the present invention, the leaflet is lifted from the fully flexible outer arm using sutures or wires, effectively causing inversion of the outer arm. This minimizes entanglement and interference with surrounding tissue when the device is desired to be removed. In mitral valve repair applications, this is particularly important due to the presence of chordae tendineae, leaflets, and other tissues that can become entangled with the device. For an approach from the atrial side of the mitral valve (in a simulated inverted position), the sutures or wires are placed at an angle of greater than about 180° to each other, preferably greater than 270°. For a ventricular approach to the valve in a simulated inverted position, the sutures or wires are oriented distally with respect to the catheter shaft, and the engagement surfaces generally face toward each other and are typically opposite each other. It will be arranged at an angle of less than about 180°, preferably less than 90°.

In the open position, the engagement surfaces of the outer arms preferably form an angle of up to 180° with respect to each other to maximize the area for capturing leaflets or other target tissue therein. The outer arms are preferably flexible to a closed position in which the engagement surfaces engage each other or form an angle as small as 0° with each other. The outer arm is flexible and can be placed in any of a variety of positions while imparting an opposing compressive force to the inner arm to allow fixation of tissues of various thicknesses, geometries, and spacings. Constructed to remain permanently.

A particular advantage of the present invention is that both the outer and inner arms are sufficiently superelastic and flexible, with only slight movement to match a) the anatomical shape of the leaflet and b) physiological forces on the leaflet. The aim is to apply a permanent and gentle (non-traumatic) reaction force to the tissue while making it possible to do so.

A particular advantage of the invention is that both the outer and inner arms are sufficiently superelastic, stretchable, and flexible, which in turn captures the leaflet in the open state into the closed final configuration. The goal is to provide gentle therapeutic tightening to the annulus (directly or via the leaflets) while preserving some natural expansion during diastole and assisting the natural contraction of the annulus during systole. This gentle tightening on the annulus potentially promotes positive remodeling of the annulus, especially in dilated annuluses of enlarged hearts. In addition, this preserves the natural annulus expansion during diastole, which in turn increases the valve orifice area for enhanced blood flow from the atria to the ventricles during diastole. Although the valve clip of the present invention may be less traumatic and more flexible than the MitraClip® device, the clip is still sufficiently robust to firmly bite and secure the valve leaflets; Thus, they can function as desired to improve flow control through the valve being treated.

Another particular advantage of the invention is that the friction elements (barbs) are located internally along the long axis of the arm body and are confined by continuous and true flanks. Unlike the MitraClip® device, the barbs are not exposed along the sides. This is advantageous because it significantly reduces the risk of entanglement of chordae tendineae, leaflets, and other tissues that can become entangled with the device. Additionally, this feature reduces the risk of tangling of sutures or wires or other such delivery catheter elements that could potentially come into contact with the fixation device.

In a preferred embodiment, the fixation device of the invention will further include at least one inner arm (or gripping element) and one outer arm (or joining element). Each inner and outer arm will be movable relative to each other and configured to capture tissue between the engagement surfaces of the inner and outer arms. Preferably, the outer arm and inner arm are independently movable, but in some embodiments they may be movable using the same mechanism. The inner arm is preferably biased toward the engagement surface of the fixation element, and vice versa, and may provide a compressive force against tissue captured therebetween.

In another aspect, the invention provides a fixation device comprising a coupling element configured for coupling to a catheter and a pair of outer arms connected to the coupling element, each outer arm gripping tissue. Hold the engagement surface to

In some applications, such as mitral valve repair, the fixation device is adapted to be removed from the delivery catheter and left permanently within the patient. In such applications, it is often desirable to promote tissue growth around the fixation device. To this end, some or all of the components of the fixation device are preferably coated with a cover or coating to promote tissue growth. In one embodiment, a biocompatible fabric cover is positioned over the outer arm and/or the inner arm. The cover may optionally be impregnated or coated with various therapeutic agents, including tissue growth promoters, antibiotics, anticoagulants, blood thinners, and other agents. Alternatively, or in addition, some or all of the fixation elements and/or coverings may be comprised of bioerodible, biodegradable, or bioabsorbable materials, thus ensuring that the repaired tissue has not grown together. Afterwards, it can be broken down or absorbed by the body.

In some applications, such as mitral valve repair, the fixation device is adapted to be removed from the delivery catheter and left temporarily within the patient. In such applications, it is often desirable to provide a blood-compatible and biocompatible surface while not encouraging tissue growth around the fixation device. To this end, some or all of the components of the fixation device are preferably coated with a cover or coating to promote blood compatibility without tissue ingrowth. In one embodiment, a biocompatible fabric cover is positioned over the outer arm and/or the inner arm. The cover may optionally be impregnated or coated with various therapeutic agents, including tissue growth inhibitors, antibiotics, anticoagulants, blood thinners, and other agents. Alternatively, or in addition, some or all of the fixation elements and/or coverings may be comprised of bioerodible, biodegradable, or bioabsorbable materials, thus ensuring that the repaired tissue has not grown together. Afterwards, it can be broken down or absorbed by the body.

The outer and inner arms will be configured to provide a sufficiently high retention force so that the fixation device remains securely fastened to the target tissue throughout the cardiac cycle. At the same time, the distal and medial arms will be configured to minimize any acute trauma to the tissue engaged by them. This allows the fixation device to be removed from the tissue after the initial application without producing clinically significant injury to the tissue. To enhance retention without creating significant trauma, the inner arm and/or outer arm may have friction-enhancing features on its surface that engages the target tissue. Such friction-enhancing features may include barbs, protrusions, grooves, apertures, channels, roughenings, covers, and coatings, among others. Preferably, the friction-enhancing features will be configured to increase the retention force of the distal and medial arms against tissue without leaving significant injury or scarring when the device is removed.

The outer and inner arms may further have a shape and flexibility to maximize retention and minimize trauma to the target tissue. In a preferred embodiment, the engagement surface of the outer arm has a concave shape configured to allow the inner arm to be nested within or retracted into the outer arm with the target tissue. . This increases the tissue surface area engaged by the outer arm and creates a tissue engagement geometry with higher retention force than a planar engagement surface. To minimize trauma, the longitudinal edges of the outer arms as well as the free ends are preferably curved outwardly away from the engagement surface so that these edges form a rounded surface against the target tissue. present. The outer arm and/or the inner arm may also deflect to a degree in response to forces on tissue engaged by them, such that the tissue will tear or become damaged in response to such forces. It may be flexible, so as to reduce the possibility.

The fixation device will include an actuation mechanism for moving the outer arm between open, closed, and inverted positions. Various actuation mechanisms may be used. In an exemplary embodiment, a suture or string or wire or lever, controllable by the user through a delivery system handle, may be used to raise and lower the outer or inner arm and capture the leaflet.

The fixation device of the present invention preferably includes a coupling member that is removably connectable to a delivery catheter. The coupling member may have a variety of configurations, but in exemplary embodiments includes a flexible rod, wire, or stylus of sufficient tensile strength that coaxially and slidably extends from the handle to the fixation device. It has a let. When desired by the user, the user operates a handle safety release mechanism that allows retraction of the coupling member. This in turn causes the coupling member to slide from the engagement element between the delivery system and the fixation device. The delivery catheter will be configured to removably connect to both the coupling member and the fixation device. In one embodiment, the delivery catheter has a round hole through the elongate member and a rod/wire/stylet slidably disposed within the hole in the elongate member. The junction of the coupling member, elongated member, and fixation device includes mating surfaces that can have a variety of shapes, including S-curves or angular or flat surfaces. A rod/wire/stylet extends from the delivery catheter through an axial channel within the outer member and maintains its connection with the fixation device. The rods/wires/stylets may be connected by a variety of connection structures, including threaded connections. Removal and retraction of the rod/wire/stylet back into the delivery catheter uncouples the delivery catheter and allows deployment of the fixation device.

The delivery device of the present invention delivers an interventional device to a target location within the body. Such interventional devices include, inter alia, fixation devices or any device that accesses tissue such as valve leaflets. The delivery devices and systems direct the interventional device to the target location through a minimally invasive approach, such as through a patient's vasculature, and provide for manipulation of the interventional device at the target location, such as to gain access to tissue. Optionally, the delivery device and system may provide for decoupling of the interventional device, allowing it to remain as an implant.

In one aspect of the invention, a delivery device is provided, preferably comprising an elongated flexible shaft suitable for introduction through tortuous passages within the body. The elongated shaft has a proximal end, a distal end, and a main lumen therebetween. Included within the delivery device is at least one elongate body, particularly at least one flexible tubular guide, extending through the main lumen. In some embodiments, the tubular guide is fixed to the shaft proximate the proximal end and proximate the distal end, and is movable laterally within the main lumen such that the tubular guide is fixed to the shaft proximate the proximal end and proximate the distal end, and is movable laterally within the main lumen. is not restricted to. Alternatively, the tubular guide may be unconstrained only at the distal portion of the shaft to provide greater flexibility in that portion.

In some embodiments, two flexible tubular guides are present. However, three, four, five, six or more flexible guides may alternatively be present. The tubular guide may be comprised of any suitable material that provides lateral flexibility while providing strength under compression, such as metal or polymeric coils. Additionally, other elongated bodies such as cylindrical rods, wires, sutures, stylets, etc. may also be present to provide additional tensile strength. In some embodiments, the main lumen is occupied by a fluid, and thus the elongate body is surrounded by such fluid.

In one aspect of the invention, the delivery device includes an actuation element movably disposed within at least one of the flexible tubular guides and extending between the proximal and distal ends. The actuating element is adapted for coupling with the movable component of the interventional element, such that movement of the actuating element moves the movable element. Such interventional elements are typically removably coupled to the distal end of the shaft. The movable component may have any of a variety of functions, including grasping, approximating, cutting, ablating, stapling, or otherwise engaging tissue. In one embodiment, the movable component provides tissue access, such as coaptation of valve leaflets. In a preferred embodiment, the interventional element has first and second tissue-engaging elements adapted to engage tissue therebetween. Accordingly, in these embodiments, the actuation element is used to move the tissue engaging element to engage tissue. Additionally, in some embodiments, the shaft and interventional element are adapted for transvascular positioning.

In one aspect of the invention, a system is provided for approximating tissue to a treatment site. In some embodiments, the system includes an elongated flexible shaft having a proximal end, a distal end, a main lumen therebetween, and at least one flexible tubular guide extending through the main lumen. It is equipped with Again, in a preferred embodiment, the tubular guide is fixed to the shaft proximal to the proximal end and proximate to the distal end, with the main lumen therebetween so as to be movable laterally within the main lumen. unconstrained within at least a portion of the lumen. In some embodiments, the system also includes an actuation element movably disposed within the tubular guide and an access device coupled to the distal end of the shaft, the access device engaging tissue therebetween. first and second engagement elements for activating, at least one of the engagement elements being movable and coupled to the actuation element.

The delivery device of the present invention allows a user to deliver a fixation device to a target site from a remote access point (whether through an endovascular or surgical approach), align the device with the target tissue, and Adapted to allow selectively closing, opening, reversing, locking, or unlocking. The delivery device will preferably have a highly flexible, kink resistant, torsionally stiff shaft with minimal elongation and high tensile and compressive strength. The delivery device also includes a movable component and an associated actuator used to move the arm between lowered and raised positions, move the arm into engagement with target tissue, and remove the outer arm from the delivery catheter. will have. A plurality of tubular guides, preferably in the form of metal coils or plastic tubes or multilumen tubes, preferably with a low coefficient of friction, extend through the inner lumen of the shaft and proximate its proximal and distal ends. Fixed to the shaft but not constrained between them, providing a highly flexible and kink resistant structure. Lines for actuating the inner arm and unlocking mechanism of the fixation device extend through these tubular guides and are removably coupled to the inner arm and unlocking mechanism.

The delivery catheter may additionally include a tether consisting of a suture or wire or flexible rod that is removably coupled to a portion of the fixation device for the purpose of retrieval of the device following removal from the delivery catheter. The tether can be a separate flexible filament extending from the delivery catheter to the fixation device, but can alternatively also be coupled to either the unlocking mechanism or the inner arm to actuate those components. It can also be a used line. In either case, the tether is removable from the fixation device, so it can be removed once the device is successfully deployed.

In some embodiments, the delivery device is further coupled to the distal end of the shaft with an actuation element movably disposed within one of the at least one flexible tubular guide and configured to move within the chamber of the heart. and a fixation device adapted for positioning. Typically, the fixation device is releasably coupled to the shaft. In some embodiments, the fixation device has at least one inner arm and at least one outer arm adapted to engage the leaflets therebetween, and at least one of the inner and outer arms. One is movable and coupled to the actuating element. Alternatively or additionally, the actuating element comprises a locking line or a flexible line, such as an inner arm line or an outer arm line.

The system may further include first and second flexible tubular guides extending through the main lumen from a proximal end to a distal end. The first and second tubular guides are preferably fixed to the shaft proximate the proximal end and proximate the distal end, and are movable laterally within the main lumen. and unconstrained within at least a portion of the main lumen. Furthermore, the first movable element extends through the first tubular guide and the second movable element is movably disposed within the second tubular guide.

The system also further includes an actuator handle connected to the proximal end of the shaft, the actuator handle having a body and first, second, and third actuation elements movably coupled thereto. and first, second, and second actuating elements coupled to the first, second, and third movable elements.

The system of the invention may additionally include a guide to facilitate introduction and navigation of the delivery catheter and fixation device to the target location. The guide is preferably tubular with a channel extending between its proximal and distal ends in which the delivery catheter and fixation device may be slidably positioned. The distal end of the guide is steerable and typically deflectable about at least one axis, preferably about two axes. The guide will have size, material, flexibility, and other characteristics suitable for the application for which it is being used. For mitral valve repair, the guide is preferably introduced into the femoral vein and into the heart through the inferior vena cava, traversing the penetration in the atrial septum and aligning with the mitral valve in the left atrium. is configured to be advanced.

Alternatively, the guide can be introduced into the brachiocephalic or axillary vein or jugular vein (neck/shoulder access), into the heart through the superior vena cava, across a penetration in the atrial septum, and into the left atrium. It may be configured to be advanced into alignment with the mitral valve.

Alternatively, the guide can be introduced into the femoral, axillary, or innominate arteries and advanced through the aorta and aortic valve into the ventricle where it is steered into alignment with the mitral valve. can be configured. In a further alternative, the guide may be configured for introduction through a puncture or incision in the chest wall and through an incision in the wall of the heart to approach the mitral valve.

In an exemplary embodiment, the guide comprises a multi-catheter guidance system having two components, including an inner tubular member or guide catheter and an outer tubular member or guide catheter. The outer tubular member has a distal end deflectable about the axis. The inner tubular member has a distal end deflectable about an additional axis. Additionally, the distal end of the inner tubular member may be angularly deflectable. Mobility in additional directions and about additional axes may optionally be provided.

The invention further provides a method of performing a therapeutic intervention at a tissue site. In one embodiment, the method includes advancing an interventional tool having a proximal end, a distal end, and a fixation device proximate the distal end to a location within a patient's body, the fixation device includes a step and a step for moving the outer arms to an open position, the step and the pair of outer arms each having a free end and an engagement surface, the free ends being spaced apart, and a pair of outer arms having an engagement surface. positioning the outer arm so that the surface engages tissue at the tissue site; and removing the fixation device from the interventional tool. Preferably, the method further includes the step of uncoupling the leaflet from the outer arm to allow evacuation or to retry the procedure.

At least one embodiment of the present disclosure includes a base section, a first outer arm having a free end and a fixed end coupled to the base, and a first inner arm having a distal end and a fixed end coupled to the base. Continuing with a tissue grasping device that includes a second outer arm and a second inner arm that are similarly coupled to the base in a modular manner, tissue is grasped between the distal and proximal arms; The proximal arm is formed from an elastoplastic material or a viscous material or a shape memory material configured to exhibit superelasticity in a physiological environment, and the base is formed from an elastic/plastic material configured to exhibit superelasticity in a physiological environment. Formed from plastic or shape memory materials.

At least one embodiment of the present disclosure is configured for intravascular delivery and for use in joining mitral (or tricuspid) tissue during mitral (or tricuspid) valve procedures. The tissue fixation system comprises a base section, a first outer arm having a free end and a fixed end coupled to the base, and a first proximal arm having a free end and a fixed end coupled to the base. a second outer arm and a second proximal arm that are similarly connected to the base in a modular manner, the tissue grasping device including a second outer arm and a second proximal arm that are similarly coupled to the base in a modular manner, the tissue being held between the distal and proximal arms; The gripped, distal and proximal arms are formed from a shape memory material configured to exhibit superelasticity in a physiological environment, and the base is made of an elastic/plastic material configured to exhibit superelasticity in a physiological environment. material or shape memory material.

At least one embodiment of the medial or lateral arm has a barb contained within a smooth lateral edge on each side of the barb to limit the risk of the tissue or delivery mechanism becoming stuck in the barb, and the barb is free from the physiological environment. It is formed from an elastoplastic material or a viscous material or a shape memory material that is configured to exhibit superelasticity at a temperature.

At least one embodiment of the fixed device delivery system includes the provision of a stand-alone or dedicated probe incorporated into the delivery system that incorporates an active ultrasound probe, the probe being retractable, translatable, rotatable, steerable. 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features (e.g., without limitation, by heartbeat and respiration), with or without the use of ultrasound markers or contrast agents. synchronization or desynchronization to limit physiological artifacts (induced); assist in assisting, identifying, and navigating before, during, and after the procedure;

At least one embodiment of the fixed device delivery system includes the provision of a stand-alone or dedicated probe incorporated into the delivery system that incorporates a passive ultrasound probe, the probe being retractable, translatable, rotatable, steerable. and, without limitation, 2D imaging, Doppler, 3D imaging, 4D imaging, physiological imaging (e.g., caused by, but not limited to, heartbeat and respiration), with or without the use of ultrasound markers or contrast agents. at least one multi-modality imaging enabling feature, such as synchronization or de-synchronization to limit artifacts, assist, identify, and navigate before, during, and/or after the procedure; have

At least one embodiment of a fixed device delivery system includes the provision of a stand-alone or dedicated probe integrated into the delivery system that incorporates an active optical coherence tomography (OCT) probe, where the probe can be retractable, translatable, rotatable, etc. capable, steerable, and including, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, with or without the use of OCT markers or contrast agents, such as, but not limited to, synchronization or desynchronization to limit physiological artifacts (caused by heartbeat and respiration), before and/or during the procedure, and/or to assist in assisting, identifying, and navigating after the procedure; It has the above-mentioned enabling characteristics.

At least one embodiment of a fixed device delivery system includes the provision of a stand-alone or dedicated probe integrated into the delivery system that incorporates a passive optical coherence tomography (OCT) probe, the probe being retractable, translatable, rotatable. capable, steerable, and including, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, with or without the use of OCT markers or contrast agents, such as, but not limited to, synchronization or desynchronization to limit physiological artifacts (caused by heartbeat and respiration), before and/or during the procedure, and/or to assist in assisting, identifying, and navigating after the procedure; It has the above characteristics.

At least one embodiment of the fixed device delivery system includes the provision of a stand-alone or dedicated probe built into the delivery system that incorporates an active optical camera-based imaging system housed inside the balloon, the balloon being When either in contact with or in the vicinity of tissue, the probe can be filled with a fluid (gas or liquid) that allows visualization, and the probe can be retractable, translatable, rotatable, steerable, etc. 2D imaging, Doppler, 3D imaging, 4D imaging, multi-modality imaging features (e.g., but not limited to heart rate and respiratory imaging), with or without the use of optical markers or contrast agents. synchronization or desynchronization to limit physiological artifacts (caused by It has special characteristics.

At least one embodiment of the fixed device delivery system incorporates a passive optical camera-based imaging system (e.g., without limitation, a fiber optic imaging system) that is housed inside the balloon, a standalone or integrated device within the delivery system. There is the provision of a dedicated probe, the balloon can be filled with a fluid (gas or liquid) that allows visualization when the balloon is either in contact with or in the vicinity of the target tissue, and the probe is retractable, translatable, rotatable, steerable, and can be used for, but not limited to, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging, with or without the use of optical markers or contrast agents. features, synchronization or de-synchronization to limit physiological artifacts (e.g., but not limited to, caused by heartbeat and respiration), pre-procedure and/or during the procedure, and/or post-procedure assistance, identification, and navigation. has at least one or more characteristics, such as being useful for gating.

At least one embodiment of a fixed device delivery system includes the provision of a standalone or dedicated probe integrated into the delivery system that incorporates an active sensor/transducer/actuator system, the probe being retractable, translatable, rotatable, Steerable and includes, but is not limited to, pressure, strain, stress, ECG, EMG, 2D imaging, Doppler, 3D imaging, 4D imaging, multimodality imaging features, with or without the use of markers or contrast agents, ( synchronization or desynchronization to limit physiological artifacts (e.g., but not limited to, caused by heartbeat and respiration), before and/or during a procedure, and/or after a procedure to assist, identify, and navigate. has at least one or more enabling features, such as to help.

At least one embodiment of a fixed device delivery system includes the provision of a stand-alone or dedicated probe integrated into the delivery system that incorporates a passive sensor/transducer/actuator system (e.g., without limitation, an RFID-based system); The probe can be retractable, translatable, rotatable, steerable, and can be used to detect pressure, strain, stress, ECG, EMG, 2D imaging, Doppler, with or without markers or contrast agents. , 3D imaging, 4D imaging, multi-modality sensing/transformation features, synchronization or de-synchronization to limit physiological artifacts (e.g., caused by, but not limited to, heartbeat and respiration), before and/or during the procedure. , and/or to assist in assisting, identifying, and navigating after a procedure.

In at least one embodiment of the fixed device delivery system, there is provision for the device to be coated to enhance biocompatibility and tissue interfaces, the coating being made of a metal such as, but not limited to, titanium, tantalum, gold, platinum, etc. , iridium, tungsten, or combinations thereof), and/or ceramics, and/or polymers, such as, but not limited to, fluoropolymers (PTFE, PFA, FEP, ECTFE, ETFE), parylene, polyester, PER, polypropylene, PEEK , PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, hydroxyapatite, CaP, THV, biodegradable materials (polylactic acid, polyglycolic acid), polydioxanone, poly(ε-caprolactone), polyacid anhydride, poly(orthoester) These coatings can be hydrophilic or hydrophobic; obtain.

In at least one embodiment of the fixed device delivery system, there is provision for the device to be coated to enhance biocompatibility and tissue interfaces, the coating being made of a metal such as, but not limited to, titanium, tantalum, gold, platinum, etc. , iridium, tungsten, or combinations thereof), and/or ceramics, and/or polymers, such as, but not limited to, fluoropolymers (PTFE, PFA, FEP, ECTFE, ETFE), parylene, polyester, PER, polypropylene, PEEK , PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, hydroxyapatite, CaP, THV, and biodegradable materials (polylactic acid, polyglycolic acid), polydioxanone, poly(ε-caprolactone), polyanhydride, poly(orthoester) ), copoly(ether-ester), polyamide, polylactone, poly(propylene fumarate), and/or combinations thereof; these coatings may be hydrophilic or hydrophobic. could be.

At least one embodiment of the present disclosure relates to a method of grasping tissue, the method comprising: positioning a tissue grasping device proximate a target tissue, the tissue grasping device being formed from a shape memory material; a first arm, and a second arm, each arm having a first end coupled to the base section and a free end extending from the base section; the two arms are positioned opposite each other, and the steps include: moving the tissue grasping device from a pre-deployed configuration toward a deployed configuration, the arms moving the tissue grasping device from the pre-deployed configuration toward the deployed configuration; the first and second arms are configured to telescopically flex toward a relaxed configuration in a distal direction as the first and second arms are moved toward the relaxed configuration.

At least one embodiment of the present disclosure relates to a method of manufacturing a tissue grasping device, the method comprising: cutting one or more structural features into a strip or sheet raw material of a shape memory alloy; The structural feature includes a plurality of slotted recesses located at one or more locations remote from a side edge of the raw material; and thermosetting the one or more bending features into the raw material. .

In a first specific aspect, a valve clip according to the invention includes a hub, a first pair of leaflet capture arms having a first inner arm and a first outer arm coupled to the hub; and a second pair of leaflet-capturing inner arms having a coupled second inner arm and a second outer arm. The outer and inner arms are biased apart to create a leaflet capture space between them such that the leaflet is captured and then self-closed over the leaflet when released. configured.

The hub is typically configured to be removably attached to the deployment shaft, and at least some of the leaflet capture arms are typically formed as leaf springs. The outer surface of each inner arm is positioned adjacent to the inner surface of each outer arm, the lower end of each arm is coupled to the hub, and the lower end of each inner arm is typically positioned above the lower end of each outer arm. be. The terms "inferior" and "superior" are defined in relation to the patient anatomy into which the valve clip will be implanted. For example, when implanted within a mitral valve, top refers to the side of the clip facing the atrium and bottom refers to the side of the clip facing the ventricle. When implanted intravenously, upper will point in the upstream direction while lower will point in the downstream direction.

The spring-loaded outer and inner arms are configured to "open" and initially capture a pair of leaflets and self-close over the leaflets after the leaflets are captured. "Unreleased" means that the individual arms may be flexed or biased so that they are moved from their normal unbiased configuration, i.e., when they are free of deformation due to the application of an external force. means.

In certain embodiments, at least some of the outer and inner arms of the valve clip are formed as "leaf springs" with a resilient base and less elastic (stiffer) valve gripping elements. The resilient base typically provides most or all of the stretch or bending capacity for the leaf spring structure and is configured such that it can be attached directly or indirectly to the hub. Valve grasping elements (eg, but not limited to barbs), in contrast, typically will undergo little or no flexing when deployed over the leaflets of a target valve. Typically, the outer and inner arms will all have a configuration as described.

In other specific embodiments, adjacent outer and inner arms of the valve clip will have generally congruent shapes. Substantially congruent means that the outer and inner arms have the same or complementary shapes and will be capable of "nesting" when attached to the hub and in its de-energized configuration. Typically, when the outer and inner arms are in their de-energized configuration and accommodate the leaflets therebetween as they are captured by the valve clips, there is typically a Typically there will be a short distance or gap between 0 mm and 6 mm, preferably between 0.5 mm and 2.5 mm. These gap values accommodate a single cusp of typical thickness between the inner and outer arms. In other specific embodiments where more than one leaflet is captured between pairs of arms, these gap values may be increased by a factor of two or three. Although there may be a minimum gap, the spring biasing of the arms may be sufficient by itself to accommodate the full range of cusp thicknesses.

In the first illustrated embodiment, the valve gripping elements of the valve clip will diverge from a common axis through the hub and form a V-shape when the outer and inner arms are deenergized. Typically, the resilient base is curved and the valve gripping element is straight on both the outer and inner arms. Even more typically, a resilient base on the lateral arm provides a gap or separation and converts the upper surface of the lateral arm from the lower surface of the inner arm to accommodate the leaflets as described above. It has an S-shaped curve that is selected to be offset or separated. Alternatively, spacers may be used between the arms to create space to accommodate the cusps.

In other illustrated embodiments, the valve gripping elements are parallel to a common axis when the outer and inner arms are deenergized. In such cases, the inner arm is generally straight, but the base of the outer arm is curved, chosen to separate the upper surface of the outer arm from the lower surface of the inner arm, in order to accommodate the leaflets therebetween. has.

In a second aspect of the invention, a system for delivering a valve clip to a cardiac or venous valve may include any of the valve clip designs described above or elsewhere or herein. . The system may further include a deployment shaft configured to be removably attached to the hub of the valve clip.

In certain embodiments of the system of the invention, the deployment shaft extends upwardly from the hub along an axis of symmetry through the hub and between the right outer and inner arms and the left outer and inner arms. obtain.

In an exemplary embodiment, the system further includes a steerable deployment catheter that is removably or fixedly coupled to the deployment shaft. In some cases, the lower end of the deployment shaft is configured to be coupled to a steerable deployment catheter. In other cases, the upper end of the deployment shaft is configured to be coupled to a steerable deployment catheter.

In yet further embodiments, the steerable catheter may include an imaging component to enable real-time visualization of the implantation procedure. The imaging components may include one or more of optical imaging components, ultrasound imaging components, OCT imaging components, or the like. Imaging components are positioned on the deployment catheter so that they can visualize both the target anatomical valve and the valve clip as it is being manipulated for implantation across the leaflets. In still further embodiments, the delivery system and/or fixation device contains a radiopaque and/or sonogenerating mechanical indicator that changes position once the leaflet is fully inserted, thereby allowing the user to It may be possible to confirm cusp insertion by visualization via fluoroscopy or ultrasound imaging.

In yet other embodiments of the system of the invention, the steerable catheter is configured to open the arms and to create a gap or space for receiving and capturing the valve leaflets on the outer and/or inner arms of the valve clip. It will include a mechanism for selectively applying a biasing force to. In the illustrated embodiment, a first set of tethers may be positioned on or through the delivery catheter and coupled to the outer arm, such that the tether selectively attaches the outer arm to the leaflet capture position. It can be tensioned to force it. A second set of tethers will typically be positioned through the delivery catheter, coupled to the inner arm, and configured to selectively bias the inner arm into the leaflet capture position. Both sets of tethers are typically further configured to selectively de-energize the outer and inner arms, such that the outer and inner arms are It is allowed to self-close towards and over the leaflet to secure the leaflet for any procedure.

In a third specific aspect, the invention provides a method of clipping an anatomical valve and fixing the leaflets of the valve to treat various medical conditions. For example, the leaflets of the mitral valve may be clipped to treat mitral regurgitation. In another example, the leaflets of a venous valve may be clipped to treat venous insufficiency.

The method of the invention includes advancing a valve clip having a pair of outer arms and a pair of inner arms into a location adjacent to a target anatomical valve. At least one of (1) the pair of outer arms and (2) the pair of inner arms is biased to open a leaflet capture space or gap between the adjacent outer and inner arms. The valve clip is then positioned such that one leaflet is positioned or captured within the gap or space between the left lateral and medial arms and another leaflet is positioned within the gap or space between the right lateral and medial arms. It is positioned in The leaflets are then attached to at least one pair of lateral or medial arms such that the left lateral and medial arms and the right lateral and medial arms self-close over the leaflets, thus securing the leaflets together. It may be secured by releasing a biasing force or tension.

In certain embodiments of the methods of the invention, both the outer arm pair and the inner arm pair will initially be energized to effect opening of the leaflet capture gap or space therebetween. Biasing is typically accomplished by pulling on a tether attached to at least one of the pairs of outer and inner arms, and typically a separate tether structure is attached to each pair of outer and inner arms. can be attached to. The tether may be tensioned to bias the outer and inner arms so that they move away from each other, creating a leaflet capture gap or space therebetween. After the outer and inner arms are biased open and the leaflets are captured, tension on the tether can be released such that the outer and inner arms self-close over the leaflets.

As an alternative to using a tether, biasing may include advancing a pair of struts or other engagement members relative to at least one pair of outer and inner arms. The strut may engage at least two lower arms or at least two upper arms and selectively open the lower and upper arms to a leaflet capture position. In some cases, the struts may engage the top surface of each outer arm, such that advancing the struts downwardly releases the outer arms relative to the inner arms. The inner arm may optionally be configured to remain stationary as the strut is advanced. In other cases, the struts may engage the underside of each inner arm, such that advancing the struts upwardly releases the inner arms relative to the outer arms. The outer arm may optionally be configured to remain stationary as the strut is advanced.

In other embodiments of the methods herein, positioning the valve clip includes manipulating a delivery catheter, and the valve clip is releasably attached to a distal end of the delivery catheter. The positioning step further includes observing a mechanical valve position indicator (as described above) and/or by using an imaging component on the delivery catheter as the valve clip is positioned. , may include viewing the anatomical valve as well as the valve clip.

A particular advantage of the present invention is the multiple sizes and shapes of fixation devices. The fixation device is configured to be attached to a smaller section of the leaflet (where the leaflet junctions together form a parallel seal) or, in a preferred embodiment, to a larger section, including the parallel joint sections of the leaflet as well as the curved contour section. I can do it. Longer contoured arms allow easier capture of the cusp.

Another particular advantage of the invention is that the fixation device is lock-free by using superelastic and fully flexible inner and outer arms.

Another particular advantage of the present invention is that the fixation device is sufficiently flexible to grip tissue reliably but atraumatically while allowing sufficient dynamic movement of the leaflets under physiological forces. It is made from the inner and outer arms of the sex.

Another particular advantage of the invention is that the friction elements of the inner and outer arms are recessed and barricaded on the sides, which reduces the risk of tangling with tendons, tissue, or the delivery system.

Another particular advantage of the invention includes modular manufacturing and/or assembly of both the outer and inner arms. Inner and outer arm combinations of various shapes and sizes can be interchangeably manufactured and/or assembled in a modular fashion to suit patient/user clinical treatment needs. For example, one side of the medial and lateral arms can be longer to grasp a larger anterior mitral leaflet, while a shorter medial and lateral arm combination is shorter to grasp a shorter posterior mitral leaflet. can be used.

Another particular advantage of the present invention is the elimination of large, increased movements of the fixation device during evacuation, such as reversal of the pointed grasping arm. This is accomplished through the use of sutures, strings, or wires to lift the leaflet away from the grasping arm.

Another particular advantage of the invention is the relatively simple and compact size of the fixation device. This allows the use of smaller diameter catheters, thus making deployment more atraumatic to the patient. For example, the MitraClip® device uses a 24Fr outer diameter guide catheter. In a preferred embodiment, the invention uses a 12Fr outer diameter guide catheter.

Another particular advantage of the present invention is its compatibility with commercially available transseptal introducer sheaths. This is accomplished by making the delivery device compatible with standard commercially available fixed or steerable transseptal introducer sheaths. Some examples of commercial inserter sheath differential designs include, but are not limited to, 7Fr, 7.5Fr, 8Fr, 8.5Fr, 9Fr, 9.5Fr, 10Fr, 10.5Fr, 11Fr, 11.5Fr, and Includes 12Fr inner diameter. Some examples of commercially available inserters include, but are not limited to, those manufactured by Merit Medical Systems, Inc. HeartSpan Fixed Curve Braided Trans-septal Sheath by (UT) and HeartSpan Steerable Sheath Introducer, Boston Scientific Corporation (M A) DIREX ^TM and Zurpaz TM Steerable Sheath by St. Including Agilis NxT ^™ by Jude Medical (MN).

Another advantage of the present invention is the potential to perform the procedure under local anesthesia, thus eliminating the risk of general anesthesia. This is accomplished by incorporating visualization techniques into or in conjunction with the delivery catheter system, replacing the need for transesophageal echocardiography (TEE).

Other objects and advantages of the invention will become apparent from the detailed description that follows, taken in conjunction with the accompanying drawings.
This specification also provides, for example, the following items.
(Item 1)
A valve clip, the valve clip comprising:
a hub configured to be removably attached to the deployment shaft;
a first pair of leaflet capture arms comprising a first inner arm and a first outer arm coupled to the hub;
a second pair of leaflet capture arms comprising a second inner arm and a second outer arm coupled to the hub;
The outer and inner arms are biased apart to create a leaflet capture space between them so that they self-close over the leaflets when released and after the leaflets have been captured. It consists of a valve clip.
(Item 2)
The valve clip of item 1, wherein at least some of the leaflet capture arms are formed as leaf springs.
(Item 3)
Item 2, wherein at least some of said outer and inner arms are formed as leaf springs with a resilient base attached to said hub and a less resilient valve gripping element extending from said base. Valve clip as described.
(Item 4)
4. The method of claim 3, wherein each of the outer and inner arms is formed as a leaf spring with a resilient base attached to the hub and a less resilient valve gripping element extending from the base. valve clip.
(Item 5)
5. The valve clip of item 4, wherein the valve gripping element diverges from a common axis and forms a V-shape when the outer and inner arms are deenergized.
(Item 6)
6. The valve clip of item 5, wherein for both the outer and inner arms, the resilient base is curved and the valve gripping element is straight.
(Item 7)
The resilient base of the outer arm has an S-shaped curve selected to separate the upper surface of the inner arm from the lower surface of the outer arm, such separation accommodating the valve leaflets. 6. The valve clip according to 6.
(Item 8)
the resilient base of the outer arm has an S-shaped curve selected to separate the upper surface of the inner arm from the lower surface of the outer arm, such separation accommodating the leaflets; The valve clip described in item 7.
(Item 9)
6. The valve clip of item 5, wherein the valve gripping element is parallel to a common axis when the outer and inner arms are deenergized.
(Item 10)
The inner arm is generally straight, but the base of the outer arm has a curve selected to separate the upper surface of the inner arm from the lower surface of the outer arm, and such separation 10. The valve clip of item 9, which accommodates a leaflet.
(Item 11)
A system for delivering a valve clip to a heart or venous valve, the system comprising:
The valve clip described in item 1;
and a deployment shaft configured to be removably attached to a hub of the valve clip.
(Item 12)
12. The system of item 11, wherein the deployment shaft extends upwardly from the hub along a line of symmetry between right outer and inner arms and left outer and inner arms.
(Item 13)
13. The system of item 12, further comprising a steerable deployment catheter coupled to the deployment shaft.
(Item 14)
14. The system of item 13, wherein a lower end of the deployment shaft is configured to be coupled to the steerable deployment catheter.
(Item 15)
15. The system of item 14, wherein an upper end of the deployment shaft is configured to be coupled to the steerable deployment catheter.
(Item 16)
14. The system of item 13, wherein the steerable deployment catheter includes an imaging component.
(Item 17)
17. The system of item 16, wherein the imaging component includes one or more of a mechanical leaflet position indicator component, an optical imaging component, an ultrasound component, and an OCT imaging component.
(Item 18)
Item 11 further comprises a first set of tethers positioned through the delivery catheter and coupled to the outer arm and configured to selectively bias the outer arm to a leaflet capture position. The system described.
(Item 19)
19. The system of item 18, wherein the first set of tethers is further configured to selectively debias the outer arm such that the outer arm self-closes toward the leaflet.
(Item 20)
Item 11 further comprising a second set of tethers positioned through the delivery catheter and coupled to the inner arm and configured to selectively bias the inner arm into a leaflet capture position. The system described.
(Item 21)
21. The system of item 20, wherein the second set of tethers is further configured to selectively debias the inner arm such that the inner arm self-closes toward the leaflets.
(Item 22)
a first set of tethers positioned through the delivery catheter and coupled to the outer arms and configured to selectively bias the outer arms to a leaflet capture position; 12. The system of item 11, further comprising a second set of tethers coupled to the inner arm and configured to selectively bias the inner arm to a leaflet capture position.
(Item 23)
further comprising a pair of struts reciprocally coupled to the deployment shaft, the struts engaging at least the two lower arms or the two upper arms to engage the lower and upper arms in leaflet capture. 12. The system of item 11, selectively opening to positions.
(Item 24)
24. The system of item 23, wherein the strut is configured to engage an upper surface of each outer arm, and advancing the strut downwardly releases the outer arm relative to the inner arm.
(Item 25)
24. The system of item 23, wherein the inner arm is configured to remain stationary when the strut is advanced.
(Item 26)
24. The system of item 23, wherein the strut is configured to engage a lower surface of each inner arm, and advancing the strut upwardly releases the inner arm relative to the outer arm.
(Item 27)
27. The system of item 26, wherein the outer arm is configured to remain stationary as the strut is advanced.
(Item 28)
A method of clipping an anatomical valve, the method comprising:
advancing a valve clip having a pair of outer arms and a pair of inner arms into a location adjacent the anatomical valve;
(1) energizing at least one of the pair of outer arms and (2) the pair of inner arms to open a leaflet capture space between adjacent outer and inner arms;
the valve clip such that one leaflet is positioned within the leaflet capture space between the left lateral and medial arms and another leaflet is positioned within the leaflet capture space between the right lateral and medial arms; positioning and
releasing the bias on the at least one pair of outer or inner arms such that the left outer and inner arms and the right outer and inner arms self-close over the leaflets and secure them; A method, including that and.
(Item 29)
29. The method of item 28, further comprising lifting the inner arm from the leaflet and releasing the valve clip from the leaflet to enable repositioning or removal of the valve clip after initial placement.
(Item 30)
30. The method of item 29, wherein the anatomical valve is a heart valve.
(Item 31)
31. The method of item 30, wherein the heart valve is a mitral valve.
(Item 32)
32. The method of item 31, wherein the anatomical valve is a venous valve.
(Item 33)
30. The method of item 29, wherein said biasing includes pulling together tethers attached to said at least one pair of outer or inner arms.
(Item 34)
34. The method of item 33, wherein said biasing includes tensioning a tether attached to each pair of outer and inner arms.
(Item 35)
35. The method of item 34, wherein releasing the bias includes releasing tension on the tether.
(Item 36)
30. The method of item 29, wherein the biasing includes manipulating a delivery catheter, and the valve clip is releasably attached to a distal end of the delivery catheter.
(Item 37)
37. The method of item 36, further comprising viewing the anatomical valve and the valve clip using an imaging component on the delivery catheter when the valve clip is positioned.
(Item 38)
The biasing may include advancing the pair of struts into engagement with at least the two lower arms or the two upper arms to selectively open a valve receiving space between the lower and upper arms. The method according to item 29, comprising:
(Item 39)
39. The method of item 38, wherein advancing the strut downwardly relative to an upper surface of each outer arm opens the outer arm relative to the inner arm.
(Item 40)
39. The method of item 38, wherein advancing the strut upwardly relative to a lower surface of each inner arm opens the inner arm relative to the outer arm.
(Item 41)
36. The method of item 35, further comprising viewing the anatomical valve and the valve clip using an imaging component on the delivery catheter when the valve clip is positioned.
(Item 42)
The valve clip of item 3, wherein at least one of the inner and outer arms has a barb or tissue fixation element trapped within a side rail or barrier to resist entanglement with a tendon or delivery system. .
(Item 43)
5. The valve clip of item 4, wherein the valve gripping element diverges from a common axis and forms a curved shape that closely matches a natural leaflet shape when the outer and inner arms are deenergized.
(Item 44)
The valve clip of item 1, wherein the inner and outer arms are configured to capture the leaflet within a coaptation segment of the leaflet.
(Item 45)
The valve clip of item 1, wherein the inner and outer arms capture the leaflet within coaptation and noncoaptation segments of the leaflet.
(Item 46)
46. The valve clip of item 45, wherein the inner and outer arms are configured to capture the leaflets within the coaptation and noncoaptation segments along the contours of the natural leaflet and annulus.
(Item 47)
The valve clip of item 1, wherein the inner and outer arms are configured to simultaneously capture a leaflet.
(Item 48)
The valve clip of item 1, wherein the inner and outer arms are configured to sequentially capture the leaflets.
(Item 49)
The valve clip of item 1, wherein the inner arm and outer arm are configured to independently capture a leaflet.
(Item 50)
15. The system of item 14, wherein the deployment shaft is configured to be coupled to a pressure sensor.
(Item 51)
15. The system of item 14, wherein the deployment shaft is configured to be coupled to an ultrasonic sensor.
(Item 52)
15. The system of item 14, wherein the deployment shaft is configured to be coupled to an OCT system.
(Item 53)
12. The system of item 11, further comprising a first set of tethers positioned through the delivery catheter and coupled to the outer arm and configured to selectively lift the leaflet from the outer arm.
(Item 54)
The item further comprising a second set of tethers positioned through the delivery catheter and coupled to the inner arm and configured to selectively raise and lower the inner arm relative to the outer arm. 53. The system described in 53.
(Item 55)
The size and shape of one pair of the medial and lateral arms are configured to capture anterior native mitral leaflets, and the other pair of medial and lateral arms are configured to capture posterior native mitral leaflets. The valve clip according to item 1, configured to.
(Item 56)
The first pair of medial and lateral arms are sized and shaped to capture a first native tricuspid valve leaflet, and the second pair of medial and lateral arms are configured to capture a second native tricuspid leaflet. 2. The valve clip of item 1, wherein the third pair of inner and outer arms is configured to capture a third natural tricuspid valve leaflet.
(Item 57)
2. The valve clip of item 1, wherein the size and shape of each pair of inner and outer arms is modular for ease of manufacturing and to accommodate variations in disease status of the valve.
(Item 58)
2. The valve clip of item 1, wherein the inner and outer arms are configured to elastically deform or stretch to partially accommodate the natural movement of the valve annulus with each heartbeat.
(Item 59)
2. The valve clip of item 1, wherein the inner and outer arms are configured to resiliently resist deformation of the captured leaflet with each heartbeat.
(Item 60)
The valve clip of item 1, wherein the inner and outer arms are configured to elastically tighten the annulus more closed by tightening the captured cusps.
(Item 61)
further comprising a pair of struts fixed to the deployment shaft and reciprocatingly coupled to the valve clip, the struts engaging at least the two lower arms or the two upper arms, and selectively opening the upper arm to the leaflet capture position.
(Item 62)
62. The system of item 61, wherein the strut is configured to engage an upper surface of each outer arm, and advancing the valve clip upwardly opens the outer arm relative to the inner arm.
(Item 63)
62. The system of item 61, wherein the inner arm is configured to remain stationary as the valve clip is advanced toward the strut.
(Item 64)
62. The system of item 61, wherein the strut is configured to engage a lower surface of each inner arm, and advancing the valve clip downwardly releases the inner arm relative to the outer arm.
(Item 65)
further comprising a pair of struts movably coupled to the deployment shaft and reciprocatingly coupled to the valve clip, the struts engaging at least the two lower arms or the two upper arms; 12. The system of item 11, wherein the lower and upper arms are selectively opened to a leaflet capture position.
(Item 66)
the struts are coupled to a set of tethers and configured to engage a top surface of each outer arm, and advancing the struts downwardly releases the outer arms relative to the inner arms; 65. The system described in 65.
(Item 67)
the struts are coupled to a set of tethers and configured to engage a lower surface of each inner arm, wherein advancing the struts upwardly releases the inner arms relative to the outer arms; 65. The system described in 65.
(Item 68)
2. The valve clip of item 1, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to simultaneously capture a leaflet.
(Item 69)
2. The valve clip of item 1, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to sequentially capture a leaflet.
(Item 70)
2. The valve clip of item 1, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to independently capture a leaflet.
(Item 71)
2. The valve clip of item 1, wherein at least the outer leaflet capture arm is releasably attached to a tether that can be used to bias or de-energize the arm. (Item 72)
Item 1, wherein at least the outer leaflet capture arm is releasably attached to a tether that can be used to raise or lower the arm and to lift the leaflet from the outer arm. Valve clip as described.
(Item 73)
At least an outer leaflet capture arm is used to bias or unbias the outer arm, lift a leaflet from the outer arm, and disengage the valve clip from the leaflet. The valve clip of item 1, wherein the valve clip is releasably attached to a tether that can be attached to a tether.
(Item 74)
Outer and inner leaflet capture arms can be used to bias or unbias the arm to capture the leaflet or release the captured leaflet from the arm. A valve clip according to item 1, releasably attached to the tether.
(Item 75)
At least the outer leaflet capture arm is configured to actuate or de-energize the arm, capture the leaflet, or release the captured leaflet from the arm, and retrieve the valve clip. The valve clip of item 1, wherein the valve clip is releasably attached to a tether that can be used to perform
(Item 76)
12. The valve clip of item 11, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to simultaneously capture a leaflet.
(Item 77)
12. The valve clip of item 11, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to sequentially capture a leaflet.
(Item 78)
12. The valve clip of item 11, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to independently capture a leaflet.
(Item 79)
12. The valve clip of item 11, wherein at least the outer leaflet capture arm is releasably attached to a tether that can be used to bias or de-energize the arm.
(Item 80)
Item 11, wherein at least the outer leaflet capture arm is releasably attached to a tether that can be used to raise or lower the arm and lift the leaflet from the outer arm. Valve clip as described.
(Item 81)
At least an outer leaflet capture arm is used to bias or unbias the outer arm, lift a leaflet from the outer arm, and disengage the valve clip from the leaflet. 12. The valve clip of item 11, wherein the valve clip is releasably attached to a tether that can be attached to a tether.
(Item 82)
Outer and inner leaflet capture arms can be used to bias or unbias the arm to capture the leaflet or release the captured leaflet from the arm. The valve clip of item 11, wherein the valve clip is releasably attached to the tether. (Item 83)
At least the outer leaflet capture arm is configured to actuate or de-energize the arm, capture the leaflet, or release the captured leaflet from the arm, and retrieve the valve clip. 12. The valve clip of item 11, wherein the valve clip is releasably attached to a tether that can be used to perform
(Item 84)
12. The valve clip of item 11, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to simultaneously capture a leaflet.
(Item 85)
12. The valve clip of item 11, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to sequentially capture a leaflet.
(Item 86)
12. The valve clip of item 11, wherein the first pair of inner and outer arms and the second pair of inner and outer arms are configured to independently capture a leaflet.
(Item 87)
12. The valve clip of item 11, wherein at least the outer leaflet capture arm is releasably attached to a tether that can be used to bias or de-energize the arm.
(Item 88)
Item 11, wherein at least the outer leaflet capture arm is releasably attached to a tether that can be used to raise or lower the arm and lift the leaflet from the outer arm. Valve clip as described.
(Item 89)
At least an outer leaflet capture arm is used to bias or unbias the outer arm, lift a leaflet from the outer arm, and disengage the valve clip from the leaflet. 12. The valve clip of item 11, wherein the valve clip is releasably attached to a tether that can be attached to a tether.
(Item 90)
The outer and inner leaflet capture arms may be used to bias or unbias the arms to capture the leaflets or release the captured leaflets from the arms. 12. The valve clip of item 11, wherein the valve clip is releasably attached to a tether that can be used.
(Item 91)
At least the outer leaflet capture arm is configured to bias or unbias the arm, capture the leaflet, or release the captured leaflet from the arm, and retrieve the valve clip. The valve clip of item 11, wherein the valve clip is releasably attached to a tether that can be used to perform.

FIG. 1A-1 illustrates the left ventricle and left atrium of a human heart during systole. FIG. 1A-2 illustrates the free edge of the mitral leaflet in normal coaptation. FIG. 1A-3 illustrates the free edge of the mitral leaflet in regurgitant coaptation. FIG. 1B-1 illustrates a fixation device mounted in a retrograde orientation relative to the apex. FIG. 1B-2 illustrates the fixation device mounted in a preferred antegrade orientation relative to the apex. 2A-2H depict various embodiments of catheter-based delivery systems used to deploy fixation devices within the heart. 2A-2H depict various embodiments of catheter-based delivery systems used to deploy fixation devices within the heart. 2A-2H depict various embodiments of catheter-based delivery systems used to deploy fixation devices within the heart. 2A-2H depict various embodiments of catheter-based delivery systems used to deploy fixation devices within the heart. 2A-2H depict various embodiments of catheter-based delivery systems used to deploy fixation devices within the heart. 2A-2H depict various embodiments of catheter-based delivery systems used to deploy fixation devices within the heart. 2A-2H depict various embodiments of catheter-based delivery systems used to deploy fixation devices within the heart. 2A-2H depict various embodiments of catheter-based delivery systems used to deploy fixation devices within the heart. 2I-1 and 2I-2 illustrate the distal segment of the introducer sheath when operated in a bi-directional steerable configuration. 2J-2P and 2Q-1-2Q-3 depict a preferred embodiment of an exemplary 12Fr catheter-based delivery system used to deploy a fixation device within the heart. 2J-2P and 2Q-1-2Q-3 depict a preferred embodiment of an exemplary 12Fr catheter-based delivery system used to deploy a fixation device within the heart. 2J-2P and 2Q-1-2Q-3 depict a preferred embodiment of an exemplary 12Fr catheter-based delivery system used to deploy a fixation device within the heart. 2J-2P and 2Q-1-2Q-3 depict a preferred embodiment of an exemplary 12Fr catheter-based delivery system used to deploy a fixation device within the heart. 2J-2P and 2Q-1-2Q-3 depict a preferred embodiment of an exemplary 12Fr catheter-based delivery system used to deploy a fixation device within the heart. 2J-2P and 2Q-1-2Q-3 depict a preferred embodiment of an exemplary 12Fr catheter-based delivery system used to deploy a fixation device within the heart. 2J-2P and 2Q-1-2Q-3 depict a preferred embodiment of an exemplary 12Fr catheter-based delivery system used to deploy a fixation device within the heart. 2J-2P and 2Q-1-2Q-3 depict a preferred embodiment of an exemplary 12Fr catheter-based delivery system used to deploy a fixation device within the heart. 3A, 3B-1, 3B-2, and 3C depict various exemplary embodiments of fixation devices. 3A, 3B-1, 3B-2, and 3C depict various exemplary embodiments of fixation devices. 3A, 3B-1, 3B-2, and 3C depict various exemplary embodiments of fixation devices. 4A-4F depict the stepwise deployment of a preferred embodiment using simultaneous leaflet capture. 4A-4F depict the stepwise deployment of a preferred embodiment using simultaneous leaflet capture. 4A-4F depict the stepwise deployment of a preferred embodiment using simultaneous leaflet capture. 4A-4F depict the stepwise deployment of a preferred embodiment using simultaneous leaflet capture. 4A-4F depict the stepwise deployment of a preferred embodiment using simultaneous leaflet capture. 4A-4F depict the stepwise deployment of a preferred embodiment using simultaneous leaflet capture. 5A-5D depict staged capture of the mitral leaflets using lateral capture via independent manipulation of the medial arms. 6A-6D depict staged capture of the mitral leaflets using lateral capture via independent manipulation of the medial and lateral arms. 7A-7F depict a staged escape procedure after any degree of leaflet capture by the arm. FIG. 8A illustrates the mechanism by which the outer arm is operated. FIG. 8B is a detailed illustration of the embodiment of FIG. 8B. FIG. 8C illustrates an intermediate position of the mechanism of FIGS. 8A and 8B for controlling the outer arm during evacuation. This position of the suture is beneficial for removing the mitral leaflets from the device. FIG. 8D is a detailed view of the mechanism of FIG. 8C. FIG. 9A illustrates a mechanism for manipulating the inner arm. FIG. 9B is a detailed view of the mechanism of FIG. 9A. FIG. 9C shows an alternative embodiment of a mechanism for manipulating the inner arm. FIG. 9D shows the mechanism of FIG. 9C with the inner arm in a collapsed state. FIG. 10A illustrates another embodiment of a deployment mechanism for controlling the clip and both the inner and outer arms. FIG. 10B is a detailed illustration of the deployment mechanism of FIG. 10A with retraction of the release rod. FIG. 10C depicts release of the valve clip using the release rod of FIG. 10B. FIG. 10D is a detailed view of the release mechanism depicted in FIG. 10C. FIG. 10E depicts retraction of the delivery system after release of the valve clip. 11 and 11A-11D illustrate a specific fixation device (valve clip) embodiment with isolated views of the inner and outer arms. 12 and 12A-12D illustrate a further embodiment of a valve clip fixation device with opposing arms having dissimilar lengths, with isolated views of the inner and outer arms. FIG. 12E illustrates the valve clip of FIG. 12 implanted within the mitral valve. FIG. 13A illustrates a further embodiment of a valve clip fixation device in which the inner and outer arms are formed by a single piece. FIG. 13B illustrates a further embodiment of a valve clip fixation device having a spacer within the base. FIG. 13C illustrates a further embodiment of a fixation device that utilizes two arms. FIG. 13D illustrates a further embodiment of a fixation device that utilizes four arms along the coaptation length of the natural apex. FIG. 13E illustrates an exemplary embodiment with three pairs of inner and outer arms. This is for example to capture the three separate cusps in the tricuspid valve. 13F-1 and 13F-2 illustrate further embodiments of base bracket 10 with contour features that allow for easier removal of the fixation device from the delivery catheter. 13G-1-13K-2 illustrate further embodiments of the release bar 16 with strut features that allow spreading of the outer arms of the fixation device during deployment. 13G-1-13K-2 illustrate further embodiments of the release bar 16 with strut features that allow spreading of the outer arms of the fixation device during deployment. 13G-1-13K-2 illustrate further embodiments of the release bar 16 with strut features that allow spreading of the outer arms of the fixation device during deployment. 13G-1-13K-2 illustrate further embodiments of the release bar 16 with strut features that allow spreading of the outer arms of the fixation device during deployment. 13G-1-13K-2 illustrate further embodiments of the release bar 16 with strut features that allow spreading of the outer arms of the fixation device during deployment. FIG. 14 illustrates a further embodiment configuration of the fixation device in which the arms on both sides are of different lengths. FIG. 15 illustrates a further embodiment configuration of the fixation device in which the arms on both sides are at different angles. FIG. 16 illustrates a further embodiment configuration of the fixation device in which the arms on both sides are at different or unconstrained angles in configuration. FIG. 17A reproduces the MitraClip® embodiment (FIG. 11B, No. US 8,057,493, B2; Page 8 of 68) showing the inner gripping arm with barbs 60 exposed on the sides. . FIG. 17B illustrates an improvement to the Mitraclip® device in which the barb 60 is repositioned within the width of the arm 60' and is in line with the tangle-resistant aspect of the present invention. 18A-18E illustrate further embodiments of fixation devices that utilize camera/optical systems with various types of viewing balloons to provide vision during deployment. 18A-18E illustrate further embodiments of fixation devices that utilize camera/optical systems with various types of viewing balloons to provide vision during deployment. 18A-18E illustrate further embodiments of fixation devices that utilize camera/optical systems with various types of viewing balloons to provide vision during deployment. 18A-18E illustrate further embodiments of fixation devices that utilize camera/optical systems with various types of viewing balloons to provide vision during deployment. 18A-18E illustrate further embodiments of fixation devices that utilize camera/optical systems with various types of viewing balloons to provide vision during deployment. FIG. 19 illustrates a further embodiment of a fixation device that utilizes an OCT sensor to provide vision during deployment. FIG. 20 illustrates a further embodiment of a fixation device that utilizes an ultrasound echography sensor to provide vision during deployment.

(Detailed description of the invention)
(I. Cardiac physiology)
The left ventricle LV of a normal heart H during systole is illustrated in FIG. 1A-1. The left ventricle LV is contracting and blood flows outward through the tricuspid (mitral) valve AV in the direction of the arrow. Reflux or "regurgitation" of blood through the mitral valve MV is due to the fact that the mitral valve is configured as a "check valve" that prevents reflux when the pressure within the left ventricle is higher than that within the left atrium LA. This is prevented because of the The mitral valve MV includes a pair of cusps with a free edge FE that evenly abuts in a closing manner, as illustrated in FIG. 1A-1. Opposing ends of leaflet LF attach to surrounding heart structures along an annular region called the annulus AN. The free edge FE of the leaflet LF connects the lower portion of the left ventricle LV through the chordae tendineae CT (hereinafter referred to as tendon), which includes multiple branching tendons that are fixed over the lower surface of each leaflet LF. Fixed. Tendon CT, in turn, attaches to the papillary muscle PM, which extends upward from the inferior portion of the left ventricle and the intraventricular septum IVS.

Several structural defects within the heart can cause mitral regurgitation. Regurgitation occurs when the valve leaflets do not close properly, allowing leakage from the ventricles into the atria. As shown in FIGS. 1A-2, the free edges of the anterior and posterior leaflets typically meet along the juncture line C. An example of a defect that causes backflow is shown in FIG. 1A-3. Here, enlargement of the heart causes the mitral annulus to become dilated, making it impossible for the free edge FE to abut during systole. This results in a gap G that allows blood to leak through the valve during ventricular systole. A ruptured or stretched tendon can also cause the leaflet to prolapse because improper tension is transmitted through the tendon to the leaflet. Although the other leaflets maintain their normal contours, the two leaflets do not meet properly and leakage from the left ventricle into the left atrium will occur. Such regurgitation can also occur in patients with ischemic heart disease, where the left ventricle does not make sufficient contact to provide proper closure.

(II. General overview)
The present invention provides methods and devices for grasping, approximating, and securing tissue, such as valve leaflets, to treat heart valve regurgitation, particularly mitral valve regurgitation. The present invention also provides features that allow repositioning and removal of the device if so desired, particularly in areas where removal may be impeded by anatomical features such as tendons CT. Such removal would allow the surgeon to re-approach the valve in a new manner, if so desired.

Grasping will preferably be atraumatic, offering several benefits. Atraumatic means that the devices and methods of the present invention can be applied to the leaflets and then removed without causing any significant clinical impairment of leaflet structure or function. The leaflets and valves continue to function substantially the same as before the present invention was applied. Therefore, some slight penetration or indentation of the tip can occur using the present invention and still meet the definition of "atraumatic." This allows the device of the invention to be applied to the diseased valve and removed or repositioned if desired without adversely affecting valve function. Additionally, in some cases it may be necessary or desirable to puncture or otherwise permanently affect the leaflet during either grasping, fixation, or both. I want to be understood. In some of these cases, grasping and fixation may be accomplished by a single device. Although several embodiments are provided to achieve these results, a general overview of the basic features will be presented herein. Such features are not intended to limit the scope of the invention, but are presented with the goal of providing a basis for the description of individual embodiments presented later in this application.

The devices and methods of the present invention rely on the use of an interventional tool that is positioned proximate the desired treatment site and used to grasp the target tissue. For intravascular applications, the interventional tool is typically an interventional catheter. In surgical applications, interventional tools are typically interventional instruments. In a preferred embodiment, fixation of the grasped tissue is accomplished by maintaining the grasp with a portion of the interventional tool that remains as an implant. Although the invention may have a variety of applications for tissue access and fixation throughout the body, it is particularly clear for the repair of valves, particularly heart valves such as the mitral and tricuspid valves. is adapted to.

1B-1 and 1B-2 illustrate the fixation device in both retrograde and antegrade configurations for deployment, respectively. The fixation device is attached to release bar 16 or 166 that is part of distal delivery catheter 499. In both surgical methods, the placement and position of the device remains unchanged. This may allow the fixed device to be deployed using a variety of entry points to best suit user needs. For illustrative purposes, an antegrade approach will primarily be described below.

2A-2H depict various embodiments of catheter-based fixation device delivery systems that may be used to deploy fixation devices. Knobs 502 and 503 connect the inner (14, 22) and outer (12, 20) arms of the fixation device to (14', 22') and (12', 20', respectively) to fix the two cusps LF. ) (and vice versa) (arm operation). Each knob may be configured to manipulate either the outer or inner arm of the device. Although only two handle systems are illustrated, the concept can be expanded to include three or more handle systems with a combination of fixed and/or steerable shaft systems.

FIG. 2A illustrates one embodiment of a delivery system that utilizes a fixed curve inserter sheath in combination with a four-way steerable delivery catheter. Arm operation knobs 502 and 503 are configured on the same catheter handle 508. Knobs 500 and 501 are used to steer the catheter's distal delivery shaft 499 in four directions, with each knob (500 and 501) providing two-way steering. Distal inserter sheath 498 maintains a fixed curve.

FIG. 2B illustrates a further embodiment of a delivery system that utilizes a fixed curve inserter sheath in combination with a bidirectional steerable delivery catheter. Arm operation knobs 502 and 503 are configured similarly to catheter handle 508. Knob 504 is used to orient the catheter's distal delivery shaft 499 in two directions and provide two-way steering. Distal inserter sheath 498 maintains a fixed curve.

FIG. 2C illustrates a further embodiment of a delivery system that utilizes a bi-directional steerable inserter sheath in combination with a delivery catheter. Inserter sheath handle 510 houses a two-way steering knob 505 for manipulating and steering distal sheath 498. This is arranged in conjunction with another handle 511, which in turn holds arm operating knobs 502 and 503. Off-the-shelf two-way steerable inserter sheath (HeartSpan® Steerable Sheath Introducer from Merit Medical, https://www.merit.com/cardiac-intervention/ep-and-crm /electrophysiology/heartspan-steerable- Note that sheath-introducer/) is shown as an example for illustrative purposes.

FIG. 2D illustrates a similar embodiment of a delivery system that utilizes a four-way steerable inserter sheath in combination with a delivery catheter. Inserter sheath handle 510 houses two two-way steering knobs 506 and 507 to manipulate and steer distal sheath 498 and provide four-way steerability. This is arranged in conjunction with another handle 511, which in turn holds arm operating knobs 502 and 503.

FIG. 2E illustrates a further embodiment of a delivery system that utilizes a bi-directional steerable guide catheter in combination with a bi-directional steerable delivery catheter. Inserter sheath handle 510 houses a two-way steering knob 505 for manipulating and steering distal sheath 498. This is placed in conjunction with another handle 515, which in turn holds the arm manipulation knobs 502, 503, plus a knob 518 that provides two-way steering of the distal delivery shaft 499. Off-the-shelf two-way steerable inserter sheath (HeartSpan® Steerable Sheath Introducer from Merit Medical, https://www.merit.com/cardiac-intervention/ep-and-crm /electrophysiology/heartspan-steerable- Note that sheath-introducer/) is shown as an example for illustrative purposes.

FIG. 2F illustrates a further embodiment of a delivery system that utilizes a two-way steerable guide catheter in combination with a four-way steerable delivery catheter. Inserter sheath handle 510 houses a two-way steering knob 505 for manipulating and steering distal sheath 498. This is arranged in conjunction with another handle 517, which in turn holds the arm operation knobs 502, 503, and in addition provides two-way steering of the distal delivery shaft 499, respectively, providing four-way steering. Hold knobs 520 and 521 to provide orientation. Off-the-shelf two-way steerable inserter sheath (HeartSpan® Steerable Sheath Introducer from Merit Medical, https://www.merit.com/cardiac-intervention/ep-and-crm /electrophysiology/heartspan-steerable- Note that sheath-introducer/) is shown as an example for illustrative purposes.

FIG. 2G illustrates a further embodiment of a delivery system that utilizes a four-way steerable guide catheter in combination with a two-way steerable delivery catheter. Steerable guide catheter handle 523 houses two two-way steering knobs 529 and 528 for manipulating and four-way steering of distal sheath 498. This is placed in conjunction with another handle 515, which in turn holds the arm manipulation knobs 502, 503, plus a knob 518 that provides two-way steering of the distal delivery shaft 499. In some embodiments, knob 518 may be configured for arm manipulation instead of delivery catheter steering.

FIG. 2H illustrates a further embodiment of a delivery system that utilizes a four-way steerable inserter sheath in combination with a two-way steerable delivery catheter. Inserter sheath handle 523 houses two two-way steering knobs 529 and 528 for manipulating and four-way steering of distal sheath 498. This is arranged in conjunction with another handle 517, which in turn holds the arm operation knobs 502, 503, and in addition provides two-way steering of the distal delivery shaft 499, respectively, providing four-way steering. Hold knobs 520 and 521 to provide orientation.

2I-1 and 2I-2 illustrate movement of distal inserter sheath 498 with a two-way steering configuration.

2J-2Q depict a preferred embodiment of an exemplary 12Fr custom catheter-based delivery system used to deploy a fixation device within the heart.

FIG. 2J illustrates a further embodiment of an exemplary 12Fr delivery system that utilizes a four-way steerable guide catheter in combination with a delivery catheter, similar to FIG. 2G, but using custom handles 745, 747. . Steerable guide catheter handle 745 houses two two-way steering knobs 529 and 528 for four-way steering of sheath 498. The steerable guide is positioned in conjunction with delivery catheter handle 747, which in turn holds arm manipulation knobs 502, 503 and is additionally configured for arm manipulation in lieu of delivery catheter steerability. Hold knob 518. In a preferred embodiment, knob 502 is used to independently operate one inner arm, while knob 503 is used to independently operate the other inner arm. A third knob 518 is used to operate the two outer arms simultaneously.

FIG. 2K shows the distal segment of the catheter system shown in FIG. 2J. As can be seen, the exemplary 9Fr outer diameter delivery catheter shaft 499 passes through the lumen of the exemplary 12Fr inner diameter steerable guide catheter shaft 498.

FIG. 2L shows the steerable guide and delivery catheter handle side by side. Exemplary stainless steel tubing 623 provides a means for supporting and mounting the steerable guide catheter handle on a suitable stand (not shown). On the other hand, the exemplary stainless steel tube 615 provides a means for supporting and translating the delivery catheter when inside the steerable guide handle.

FIG. 2M shows a detailed view of the delivery catheter handle with flush port 715, which may optionally be used to measure hemodynamic pressure at release bar 16. Additionally, the figure shows an exemplary quarter turn lock release rod knob 550. Knob 550 can be used to manipulate release rod 18 and thereby release/deploy the fixation element.

FIG. 2N shows an exemplary distal segment of a custom delivery catheter.

FIG. 2O shows details of the steerable guide handle 745 with the dilator proximal shaft 403 and the quarter-turn locking dilator knob 730. In addition, the steerable guide catheter handle comprises a lockable and pinchable hemostasis valve 735. When unlocked and not clamped by a user, the hemostatic valve collapses tightly closed upon itself to provide a hemostatic seal. As shown in FIG. 2O, if dilator 403 (or delivery catheter) is present, this is then closed over dilator 403 (or delivery catheter), in addition to providing a hemostatic seal. will also constrain movement of the dilator 403 (or delivery catheter).

When locked using lock 727 as shown in FIG. 2P or clamped by the user, the hemostasis valve opens, allowing free movement or passage of the dilator (or delivery catheter). . Optional and exemplary indicia 700 and 702 indicate the steerable function of knobs 520 and 528.

FIG. 2Q-1 shows a detailed view of the distal segment of steerable guide catheter shaft 498. Shaft 498 is wire reinforced to provide the required kink resistance, torqueability, and pushability. Proximal shaft 405 is relatively stiff, while distal steerable shaft 402 is relatively flexible, and intermediate shaft 401 provides an intermediate level of mixed stiffness. Three radiopaque markers 400 are present to enhance visualization under fluoroscopy.

FIG. 2Q-2 shows one of the example indicators 702. Manipulation of the corresponding knob (528 as shown in FIGS. 2O, 2P) results in exemplary steering of the distal segment 402, 401 of the steerable guide catheter shaft 498.

3A-3C illustrate example prototypes of fixed device types.

Figure 3A shows an initial barebones prototype in which the inner and outer arms are fastened using sutures and pins. Additionally, in this exemplary prototype, the inner and outer arms are contoured to allow for additional gripping beyond the required coaptation of the native valve. The inner and outer arms of this example prototype were made from Nitinol.

FIG. 3B-1 shows yet another exemplary embodiment of a contour fixation device. As can be seen, this is a complete prototype of the fixation device (with inner arms 14, 22, outer arms 12, 20, base bracket 10, and fasteners 24). The inner and outer arms of this exemplary prototype are made from Nitinol, while the base bracket 10 and fasteners 24 are made from titanium.

FIG. 3B-2 shows the individual inner arms 14, 22 and outer arms 12, 20 of the fixation device shown in FIG. 3B-1. Note that the outer arms of FIGS. 3B-1 and 3B-2 have fewer barbs or friction elements when compared to the prototype outer arms shown in FIGS. 3A or 3C.

FIG. 3C shows yet another exemplary embodiment of a contour fixation device. As can be seen, this is a complete prototype of the fixation device (with inner arms 14, 22, outer arms 12, 20, base bracket 10, and fasteners 24). The inner and outer arms of this exemplary prototype are made from Nitinol, while the base bracket 10 and fasteners 24 are made from titanium. Compared to the fixation device profile prototype of FIGS. 3A and 3B-1, this prototype is primarily designed for the coaptation area of the native valve.

4A-4F depict arm operations to be controlled by knobs 502, 503, and/or 518, for example. Specifically, these figures illustrate the preferred stepwise deployment of the fixation device in the antegrade orientation.

Prior to insertion of the device and delivery assembly through the mitral valve, the device remains collapsed inside the steerable guide catheter shaft 498 and all arms are folded upward. This is illustrated in FIG. 4A by the position of arms 12, 20, 14, 22.

FIG. 4A shows operations 60 and 61 of outer arms 12 and 20 to positions 12' and 20' after insertion of the device past the mitral leaflet LF.

FIG. 4B further illustrates this by showing the final position of the upwardly facing outer arms 12 and 20 directly below the leaflets LF.

FIG. 4C shows repositioning of the fixation device such that the mitral leaflet LF is fixed by the outer arms 20 and 12. This is accomplished by translating the device approximately 1 cm toward the atrium.

Figure 4D shows capture of leaflet LF by movement 62 and 63 of arms 14 and 22 to positions 14' and 22'. The barbed feature of the element secures the leaflet LF to the fixation device.

FIG. 4E further illustrates the final result of the capture in which arms 14, 22, 12, and 20 effectively captured the mitral leaflet LF.

FIG. 4F shows the deployment state of the fixation device. Note that FIG. 4F is the final state of all described procedures for deployment of the preferred embodiment.

5A-5D depict arm operations to be controlled by knobs 502, 503, and/or 518, for example. Specifically, these figures illustrate gradual deployment of the fixation device in an antegrade orientation, with inner arms 22 and 14 each independently capturing the leaflet.

FIG. 5A illustrates the preferred embodiment after its placement beneath the mitral leaflet LF, as previously described in FIG. 4C.

FIG. 5B depicts an independent operation 62 to lower the inner arm 22 to position 22' and capture the first leaflet LF.

FIG. 5C illustrates the advanced position of operation 62.

FIG. 5D depicts independent manipulation 63 of the second inner arm 14 into position 14' to capture the second leaflet LF. Note that the order of operations 62 and 63 can be permuted to meet preferred user needs.

6A-6D depict alternative variations of independent arm manipulation to continuously capture the cusp LF. Specifically, these figures illustrate stepwise deployment of the fixation device in an antegrade orientation for the purpose of expressing the idea.

FIG. 6A illustrates operation 60 of outer arm 20 to position 20'. The device must now be positioned such that the cusp LF is juxtaposed to the barbed feature of the arm 20.

FIG. 6B shows the position 22' of the inner arm 22. 6 shows capture of cusp LF by descent 62 to . This captures the first cusp LF.

The result of operation 60 followed by operation 62 is shown in FIG. 6C, where the device successfully captured one cusp LF. It also shows operation 61 for repositioning outer arm 12 to position 12'.

FIG. 6D illustrates the operation 63 of lowering the inner arm 14 to position 14' to capture the second leaflet LF.

Note that operation pairs (60, 62) and (61, 63) can be replaced to meet user needs.

The results of the operations depicted in FIGS. 6A-6D are illustrated in FIG. 4E, with arms 14, 22, 12, and 20 effectively capturing the mitral leaflet LF.

The preferred embodiment is designed to allow the user to abort device deployment following any complications. Additionally, an escape maneuver may be required to correct or reposition suboptimal capture of the leaflet. An example of an "escape" maneuver is illustrated in FIGS. 7A-7F.

FIG. 7A shows an exemplary fixation device after complete capture of the mitral leaflet LF.

FIG. 7B shows release of leaflet LF by lifting inner capture arms 22 and 14 to positions 22' and 14' via operations 64 and 65. FIG. 7C depicts the final results of operations 64 and 65. FIG. 7D illustrates actuation 51 and 52 of sutures 47 and 48 such that suture segments 42 and 44 are translated to positions 42' and 44'. Note that this translation lifts the cusp LF from the outer arms 12 and 20 to position LF'. FIG. 7E shows the final result of these operations 51 and 52. FIG. 7F shows a further embodiment of operations 51 and 52 in which arms 20 and 12 are completely collapsed upwards. At this stage, prolapse is complete and the fixation device can be retracted away from the mitral valve and into the atrium. The user may elect to retry the procedure or completely retract and remove the fixation device and delivery catheter 499 through the steerable guide catheter shaft 498.

8A-8D provide a more detailed depiction of movement and manipulation of the fixation device, focusing on the sutures connecting the fixation device to the delivery system.

FIG. 8A illustrates the back side of the device (facing component 16) without showing the inner arms 14 and 22 to avoid illustration confusion. This depiction represents the position of all other device elements while outer arms 12 and 20 are ready for capture. Suture 95 follows the catheter tube and elements 28 and 16 and then advances through loop 98 to form segments 91 and 93. Suture 97 is advanced through catheter tube and elements 28 and 16 to form segments 92 and 94. The distal ends of sutures 91 and 92 are looped through hole 30 and onto release rod 18. Suture 96 also follows the catheter tube and the anterior side of elements 28 and 16, which in turn advances through feature 30 to be looped through loop 98. FIG. 8B is a zoomed-in image of FIG. 8A, designated by a circle drawn around feature 30. Note that the use of loop 98 may lose practical meaning by utilizing a loop at the distal end of suture 96.

FIG. 8C represents a further embodiment illustrated in FIG. 8A. Here, operations 110, 111, and 112 translate suture segments 93, 94, and 98 from their original positions held in FIG. 8A. Note that while operations 110 and 112 may be via a knob on the handle (e.g., knob 518), this removes the leaflet LF from its position on the outer arms 12 and 20 and allows evacuation. I want to be FIG. 8C is essentially a more detailed illustration of the preferred embodiment of FIG. 7E. FIG. 8D provides a zoomed image of the embodiment of FIG. 8C, designated by a black circle drawn around element 30. In a preferred exemplary embodiment, operations 110 and 112 may be active manipulations of knobs on the delivery handle (e.g., simultaneous pulling of both 110 and 112 using a single knob 518), while operation 111 is Note that it can be passive (e.g. applying constant tension using a spring).

9A-9D provide more detailed views of the mechanisms that operate inner arms 14 and 22. Note that the sutures and mechanisms involved in outer arms 12 and 20 are not shown in FIGS. 9A-9D for simplicity.

FIG. 9A illustrates the fixation device prior to operations 77 and 78 acting on sutures 75 and 76 to collapse inner arms 14 and 22. Note that suture 76 also consists of segments 74 and 72. Similarly, suture 75 consists of segments 73 and 71. The distal ends of segments 71 and 72 are looped around release rod 18 through feature 26 on deployment bar 16. FIG. 9B provides an enlarged view of the mechanism and suture described above, designated by the circle drawn around feature 26. FIG. 9C depicts a further embodiment of the fixation device in which suture segments 71 and 73 loop through separate suture loops 83 attached to inner arm 14. Similarly, suture segments 72 and 74 loop through separate suture loops 82 and suture loops through loops 83 and 82. FIG. 9D shows a fixation device in which continuation of operations 77 and 78 successfully collapsed inner arms 14 and 22. This is essential in escape procedures as it allows the device to become compact for retraction. Additionally, this maneuver to raise and lower the inner arm while keeping the outer arm lowered allows the user to make several attempts to capture the leaflet.

10A-10E illustrate deployment and separation of the fixation device from the delivery system.

FIG. 10A depicts the fixation device in its final position after capturing the mitral leaflet LF (not shown). FIG. 10B is a zoomed image of the circular portion of FIG. 10A, designated by a circle drawn around element 30. Here, operation 180 acts on release rod 18 as it is pulled out of the delivery system using, for example, release rod knob 550. The result of this operation is shown in FIG. 10C, where the fixation device is effectively separated from the deployment bar 16. FIG. 10D depicts the effect of operation 180 on suture segments 91 and 92, which are unlinked from the device due to removal of release rod 18 and retracted along their length up through the delivery system. Ru. Note that release of suture segments 71 and 72 occurs through the same mechanism through feature 26. The final result of release can be visualized in FIG. 10E, with the device successfully implanted within the heart and the distal delivery system ready for retraction.

FIG. 11 shows an example embodiment with inner (22, 14) and outer (12, 20) arm struts configured on the outside of the fixation device. Additionally, this is a flat pattern inside (22", 14") and outside (12", 20") to illustrate one method of manufacturing arms using laser or wire EDM cut Nitinol flats. Showing the arm.

FIG. 12 shows an example of a preferred embodiment with inner (22, 122) and outer (120, 20) arm struts configured on the outside of the fixation device. Note that the medial 122 and lateral 120 arms are shorter than 22 and 20 and accommodate shorter posterior mitral leaflets. Additionally, it shows inner (122") and outer (120") arms in a flat pattern to illustrate one method of manufacturing arms using laser or wire EDM cut Nitinol planes.

13A-13E illustrate various alternative embodiments of fixation devices. Note that any combination of these embodiments and those discussed above may be used to address desired user needs.

FIG. 13A illustrates an embodiment in which both outer arms are formed as a single continuous branch outer arm component 201 that grips the cusps on each side. Similarly, both inner arms are formed as a single continuous branch inner arm component 202 that grips the cusps on each side.

FIG. 13B shows an example of an embodiment of a fixation device in which there is a spacer 203 between the inner arms. The present spacer a) provides space for a thicker leaflet LF, b) provides additional flexibility to the inner arm, and c) provides an alternative site for removably coupling the fixation device with the delivery catheter. provide.

FIG. 13C illustrates an example of a valve clip fixation device embodiment having only two outer arms 204 and no inner arms, designed to capture leaflet LF. Additionally, FIG. 13C shows an example of an embodiment of a fixation device in which there is a spacer 203 between the arms. The spacer can be used to provide a gap for tissue capture or for attachment of a fixation device to a delivery catheter.

FIG. 13D illustrates a valve clip fixation device embodiment that uses pairs of outer arms 136, 132 and inner arms 134, 138 primarily to capture the leaflet LF along the coaptation line 205 of the native valve. In contrast to the previous embodiment where the capture arm diverges from the junction line when grasping the leaflet, the capture arm of FIGS. 13C and 13D is aligned parallel to the junction line when grasping the leaflet.

FIG. 13E shows an embodiment of a valve clip fixation device in which there are three pairs of inner and outer arms 206. This is for grasping three sets of leaflets such as the tricuspid valve.

13F-1 and 13F-2 illustrate an exemplary embodiment of the base bracket 10 with a sloped feature 11 that enhances easy removal onto the fixation device upon removal of the release rod 18 during deployment.

13G-1-13G-4 show an exemplary embodiment of a release bar 16 with two struts 17. The struts assist in spreading (or lowering) the outer arm during leaflet capture while allowing seamless removal from the fixation device during deployment.

13H-1 and 13H-2 illustrate the function of strut 17. 13H-1 and 13H-2 show rear and side views, respectively, of release bar 16 and base bracket 10 and release rod 18 subassemblies. Note that arms are not shown for clarity. In the starting position, the base bracket 10 is in a lower position and a gap 54 exists between the strut 17 and the base bracket 10.

In FIGS. 13I-1 and 13I-2, the base bracket is manipulated toward the strut 17 using, for example, a wire or suture connected to one of the delivery catheter handle knobs. This operation results in a reduction of the gap 54.

13J-1 and 13K-2 schematically show a portion of the front view of release bar 16, release rod 18, and outer arms 132, 136 and inner arms 134, 136. Figure 13J-1 shows the base bracket 10 in the starting position. In this exemplary embodiment, the inner and outer arms are typically made from a superelastic material such as Nitinol. The outer arm is shaped towards a vertical position while the inner arm is shaped towards a horizontal position. Thus, while there is a constant bias for the outer arm to move towards the vertical position as in Figure 13D, the inner arm is always biased towards the outer arm. Additionally, the outer arm is made stronger compared to the inner arm, for example by using a thicker outer arm. Further, the inner arm is positioned in the raised position, for example, using the technique described above in FIG. 9D. The outer arm is therefore constrained only by the struts 17. In FIG. 13J-2, the base bracket 10 is manipulated upwardly toward the post 17. This results in the desired lowering of the outer arms as they are forced down relative to the struts 17.

13K-1 and 13K-2 are similar to FIGS. 13J-1 and 13J-2, with the inner arms 134, 138 preset to the lowered position.

Although Figures 13G-1-13K-2 show the struts fixed to the release bar 16, it will be apparent to those skilled in the art that the struts could be made movable. For example, a strut can be mounted on a lever arm, hinged to the release bar 16, and used to operate the arm with the mechanical advantage of using a tether.

FIG. 14 shows an example of an embodiment in which the outer arm does not have barbs or friction elements. Alternatively, the inner arm may or may not have barbs or friction elements. Additionally, the length of each individual medial or lateral arm is

Offset length A=0-100mm, B=0-100mm, C=0-100mm, D=0-100mm, and A≧B, or B≧A, or B≠A, C≧D, or D≧C , or C≠D, B≧D, or D≧B, or B≠D, A≧C, or C≧A, or C≠A. Note that although only offset lengths have been depicted, the same may apply to individual physical lengths of the entire arm or only the sections of the arm that engage the cusps. That is, each individual arm can be of different sizes in thickness, length, and width.

FIG. 15 shows final angles (Af, Bf, Cf, Df)=0 to 180 degrees, and angle Af≧angle Bf, or angle Af≦angle Bf, or angle Af≠angle Bf, angle Cf≧angle Df, or angle Cf≦Angle Df, or Angle Cf≠Angle Df, Angle Af≧Angle Cf, or Angle Af≦Angle Cf, or Angle Af≠Angle Cf, Angle Bf≧Angle Df, or Bf≦Angle Df, or Angle Bf≠Angle Df. 3 illustrates various configurations of fixation device embodiments such as; In a preferred configuration, the inner and outer arms are elastically or superelastically biased toward each other with sufficient force to ensure capture of the leaflet when placed between them. Please note.

FIG. 16 shows the final angle (As, Bs, Cs, Ds) = 0 to 180 degrees, and angle As≧angle Bs, or angle As≦angle Bs, or angle As≠angle Bs, angle Cs≧angle Ds, or angle Cs≦Angle Ds, or Angle Cs≠Angle Ds, Angle As≧Angle Cs, or Angle As≦Angle Cs, or Angle As≠Angle Cs, Angle Bs≧Angle Ds, or Angle Bs≦Angle Ds, or Angle Bs≠Angle. 3 illustrates various configurations of fixation device embodiments such as Ds. In a preferred embodiment, the final and shaping angles have the following relationships: angle Af≦angle As, angle Bf≦angle Bs, angle Cs≦angle Cf, angle Df≦angle Ds, angle As≠angle Bf, angle Cs ≠ may have an angle Ds.

FIG. 17A reproduces the MitraClip® embodiment (FIG. 11B, No. US 8,057,493 B2; Page 8/68) showing the inner gripping arm with barbs 60 exposed on the sides.

FIG. 17B shows a further embodiment of the present invention in which the MitraClip® external barb 60 of FIG. 17A is replaced with an internal barb 60' (FIG. 17B) and redesigned with it, consistent with the present invention. Depict. In the present invention, designing the arms such that the barbs are within the arms rather than external to the arms further ensures that tendons, tissues, or delivery device components (e.g., sutures or wires) may be unintentionally or accidentally to ensure that the fixation device does not become snagged, tangled, or structurally compromised during manipulation of the fixation device within the heart.

FIGS. 18A-18C illustrate embodiments to aid in fixed visualization during the procedure. This is accomplished via an optical camera with a light source 800 embedded inside a balloon 802 filled with a clear liquid such as saline or DI water. Alternatively, the in-situ camera and/or light source may be replaced with a fiber optic-based scope.

FIG. 18B shows an example embodiment in which the balloon is inflated through the delivery catheter lumen and optical visualization is achieved along the surface of the transparent balloon. In this embodiment, semi-compliant or variable stiffness balloon configurations may be used. During deployment, balloon 802 is inflated using clear saline or DI water to contact the clip and/or tissue and provide visual feedback via camera 800. Visual feedback can be used to plan and perform the procedure.

FIG. 18C shows an example of a porous outer balloon 804 surrounding a non-porous inner balloon 806 surrounding an optical camera with a light source 800, the porous outer balloon displacing surrounding blood for improved visualization. .

FIG. 18D shows an optical camera with a light source 800 on a retractable/steerable structure inside a balloon 808 with variable compliance. The high-compliance inner surface 812 of the balloon conforms to the top surface of the clip and leaflet, providing improved contact for increased visualization. The top surface 812 of the balloon may be more rigid to ensure full inflation of the balloon 810 over the clip and tip. Balloon 810 may be on a delivery catheter or implant, or as a standalone device.

FIG. 18E shows a pair of optical cameras or fiber optic sensors 820 housed within or on a balloon 822 mounted on a retractable/steerable structure 824. Alternatively, these sensors/cameras may be mounted on the steerable/retractable shaft 826.

FIG. 19 shows one or more optical coherence tomography (OCT) sensors 830 attached to the distal shaft 832 of the delivery system. These sensors 830 may be mounted in multiples or on a retractable and/or steerable shaft 834. This would allow high resolution tissue and delivery device imaging during implantation.

FIG. 20 shows one or more ultrasound sensors 840 attached to the distal shaft 842 of the delivery system. These sensors 840 may be mounted in multiples or on a retractable and/or steerable shaft 844. This would allow 2D, 3D, and Doppler modalities to be integrated to help navigate and perform the procedure.

Note that any combination of the embodiments illustrated in FIGS. 18A-E-20 may be used as part of the present invention to accomplish visualization. In preferred embodiments, these visualization ideas disclosed should be sufficient to replace transesophageal echocardiography (TEE) and/or fluoroscopy. TEE is one of the major reasons patients receive general anesthesia during the procedure. Therefore, eliminating the requirement for TEE during the procedure reduces the risks associated with general anesthesia. On the other hand, reducing fluoroscopy reduces the risk from X-rays.

Sensors and actuators that can be used in connection with the present invention are to improve the safety, ease of use, and effectiveness of delivery systems and fixation devices. Sensors and actuators can be used to assist and evaluate device delivery (acute) and efficacy (acute or chronic). Sensors and actuators may be active or passive, removable or implantable, and may provide acute or chronic physiological or non-physiological data to determine or assess patient health. Sensors and actuators may be active or passive, removable or implantable, provide acute or chronic physiological or non-physiological data to determine or assess implant integrity, and/or Functional sensors may be used for visualization; thermal, optical, ultrasound (including ICE), OCT, fluorescence sensors and actuators may be electrical, mechanical, magnetic, RF, chemical, or a combination. obtain. Sensors and actuators may be wired or wireless and may communicate with mobile or fixed external interfaces. Catheters of the invention can be used as conduits for external sensors, such as pressure sensors to replace Swan-Ganz catheters. The terms sensor and actuator may be used interchangeably. The sensors and actuators listed are examples only. Any suitable metallic or polymeric or ceramic, organic or inorganic, flexible or rigid, matrix or material, and combinations thereof, may be used to produce the desired sensors and actuators.

All implant embodiments described in this invention may optionally be coated, deposited, coated, or the like to improve biocompatibility and tissue interfaces. Suitable covers may be woven, woven, fibrous, braided, woven, or non-woven. The coating can be metallic, ceramic, polymeric, or a combination thereof. Suitable metal coatings include titanium, TiN, tantalum, gold, platinum, and alloys thereof. Suitable ceramic and inorganic coatings include titanium dioxide, hydroxyapatite, CaP, and the like. Suitable polymeric coatings include fluoropolymers such as PTFE, PFA, FEP, ECTFE, ETFE, parylene, polyester, PET, polypropylene, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, THV, and the like. Suitable biodegradable materials include poly(lactic acid), poly(glycolic acid), polydioxanone, poly(ε-caprolactone), polyanhydride, poly(orthoester), copoly(ether-ester), polyamide, polylactone, including poly(propylene fumaric acid), and combinations thereof. Such metallic, ceramic and/or polymeric coatings are listed by way of example only. Any suitable metals, ceramics, polymers, and combinations thereof may be used to produce the desired coating.

Below is a list of reference numbers used in this application.

Although many embodiments of the present disclosure have been described in detail, certain variations and modifications will become apparent to those skilled in the art, including embodiments that do not provide all of the features and benefits described herein. Dew. It will be understood by those skilled in the art that this disclosure extends beyond the specifically disclosed embodiments to other alternative or additional embodiments and/or uses and obvious modifications and equivalents thereof. . Additionally, while some variations have been shown and described in varying detail, other modifications that are within the scope of this disclosure will be readily apparent to those skilled in the art based on this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the disclosure. Thus, it is to be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for each other to form variable modes of the present disclosure. Therefore, it is intended that the scope of the disclosure herein should not be limited by the particular disclosed embodiments described above. For all of the embodiments described above, any method steps need not be performed sequentially.

Claims (1)

such as tissue grasping devices or related methods.