Fixation system with leaflet capture assessment

Abstract

A fixation system includes a delivery device, a fixation device, and an optical coherence tomography (OCT) catheter. The delivery device includes a shaft defining a lumen. The fixture includes a first clamp, a second clamp, and a central portion. The central portion is releasably connected to a distal end of a shaft of the delivery device, and the first and second grips define respective first and second lateral ranges of the fixture device. The OCT catheter includes an imaging probe including a first end, a second end, and a first lens assembly disposed at the second end of the imaging probe. In an assembled state of the fixture system, the imaging probe extends through the lumen and out of the second end of the shaft such that the lens assembly is positioned between the first lateral extent and the second lateral extent of the fixture.

Description

Cross-references to related applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 579,824, filed on August 31, 2023, the disclosure of which is incorporated herein by reference. Background Technology

[0002] This disclosure generally relates to medical methods, apparatus, and systems. Specifically, this disclosure relates to methods, apparatus, and systems for endovascular, percutaneous, or minimally invasive surgical treatment of body tissues, such as tissue access or valve repair. More specifically, this disclosure relates to apparatus and methods for repairing heart and venous valves and for assessing the quality of valve leaflet capture and access via minimally invasive surgery.

[0003] Surgical repair of body tissues typically involves tissue proximity and securing these tissues within a proximal arrangement. When repairing valves, tissue proximity involves occluding the valve leaflets within a treatment arrangement; this occlusion can then be maintained by securing or fixing the leaflets. This occlusion can be used to treat regurgitation, most commonly found in the mitral valve, but less frequently also in the tricuspid valve.

[0004] Mitral and tricuspid regurgitation are characterized by backflow from the ventricles of the heart through a dysfunctional valve into the corresponding atrium. During the normal circulation of the heart (systole), the mitral and tricuspid valves act as check valves to prevent blood from flowing back into the left and right atria, respectively. In this way, oxygenated blood is pumped from the left ventricle into the aorta via the aortic valve, and deoxygenated blood is pumped from the right ventricle to the lungs via the pulmonary valve. Valvular regurgitation can significantly reduce the heart's pumping efficiency, thus putting patients at risk of severe, persistent heart failure.

[0005] Valvular regurgitation, whether mitral or tricuspid, can be caused by a variety of different mechanical defects in the valve or the corresponding ventricular wall. The valve leaflets, the chordae tendineae connecting the leaflets to the papillary muscles, the papillary muscles themselves, or the ventricular wall may be damaged or have other functional impairments. Typically, the valve annulus may be damaged, dilated, or weakened, thus limiting the valve's ability to close adequately against high ventricular pressure.

[0006] The most common treatments for mitral and tricuspid regurgitation rely on valve replacement or repair involving leaflet and / or annular remodeling, often referred to as annular plasty. A valve repair technique that relies on suturing adjacent segments of opposing leaflets together is known as the "bow tie" or "edge-to-edge" technique. While all these techniques can be effective, they typically require open-heart surgery, in which the patient's chest cavity is opened via a sternotomy, and a cardiopulmonary shunt is performed. The need to both open the chest cavity and perform a shunt is invasive and associated with high mortality and morbidity rates.

[0007] However, in some patients, edge-to-edge fixation can be achieved using fixation devices, which can be implanted into the heart using minimally invasive techniques. Fixation devices can hold opposing leaflets together and can reduce valvular regurgitation. One such device for clamping the anterior and posterior leaflets of the mitral valve together is the MitraClip® fixation device, sold by Abbott Vascular in Santa Clara, California, USA, and another such device for clamping opposing leaflets of the tricuspid valve together is the TriClip® fixation device, sold by Abbott Vascular in Santa Clara, California, USA. Summary of the Invention

[0008] In one example of this disclosure, a fixation system for engaging a patient's tissue includes a delivery device. The delivery device includes a shaft defining a lumen extending from a first end to a second end of the shaft. The system also includes an implantable fixation device having a first clamp, a second clamp, and a central portion connected to and extending between the first and second clamps. The central portion is releasably connected to a distal end of the shaft of the delivery device. The first clamp defines a first lateral extent of the fixation device, and the second clamp defines a second lateral extent of the fixation device. The system also includes a first optical coherence tomography (“OCT”) catheter configured for cardiovascular imaging and having a first imaging probe including a first end, a second end, and a first lens assembly disposed at the second end of the first imaging probe. The first imaging probe is configured to transmit light between the first and second ends of the first imaging probe. In the assembled state of the fixed system, the first imaging probe extends through the lumen and from the second end of the shaft, such that the first lens assembly is positioned between the first lateral range and the second lateral range of the fixed device.

[0009] Additionally, the first imaging probe may include a sheath and an optical fiber disposed within the sheath. A first lens assembly may be disposed at the end of the optical fiber. The optical fiber is rotatable and translatable within the sheath. Furthermore, the OCT conduit may include a flushing feature having an inlet port at a first end of the first imaging probe and an outlet port at a second end of the first imaging probe. The lens assembly may include a lens and a beam deflector. The beam deflector may be configured to deflect light transmitted through the first imaging probe in a direction radially outward from the central axis of the imaging probe. The beam deflector may also be configured to deflect light at a perpendicular angle relative to the central axis.

[0010] Furthermore, the delivery device may include a handle connected to a first end of the shaft. The handle may have an OCT probe engagement configured to receive and guide a first imaging probe into a lumen of the shaft. The lumen may be a first lumen among a plurality of lumens. The delivery device may also include an actuator rod extending through a second lumen among the plurality of lumens and extending from a second end of the shaft, at which the actuator rod engages a central portion. The actuator rod may be configured to move a first clamping member and a second clamping member from a first position to a second position.

[0011] Continuing the example, the first plane and the second plane can each bisect the central portion. The first plane can be orthogonal to the second plane and can intersect with the first clamping member and the second clamping member. The second plane can be positioned equidistant from each of the first and second clamping members. Alternatively, the first lens assembly can be positioned adjacent to the central portion such that the first plane intersects with the first lens assembly. Alternatively, the first lens assembly can be positioned adjacent to the central portion such that the second plane intersects with the first lens assembly. The first and second planes can also define four quadrants arranged around the central portion. As another alternative, the first lens assembly can be positioned adjacent to the central portion and located within one of the four quadrants.

[0012] Furthermore, the first clamping member may include a first proximal element and a first distal element. The second clamping member may include a second proximal element and a second distal element. The first imaging probe may extend distally along a central portion and proximally into the space between the first proximal element and the first distal element of the first clamping member, such that the first lens assembly is positioned within this space. The first distal element may include a crossbar extending across at least a portion of its mating surface. The first imaging probe may extend between the crossbar and the mating surface. The first lens assembly may be positioned at either the proximal end or the distal end of the crossbar.

[0013] Additionally, the first imaging probe can extend distally along the central portion and proximally along the proximal side of the proximal element. The first imaging probe can be connected to the first side of the proximal element.

[0014] The system may also include a second OCT catheter having a second imaging probe and a second lens assembly. The second imaging probe may extend from the axis of the delivery device such that the second lens assembly is positioned between a first lateral range and a second lateral range in any of the previously described arrangements with respect to the first imaging probe.

[0015] In another example of this disclosure, a fixation system for engaging a patient's tissue includes an implantable fixation device. The implantable fixation device includes a first fixation element and a second fixation element, each capable of defining a respective lateral extent of the fixation device. The implantable fixation device may further include: a first grasping element movable relative to the first fixation element between a first position and a second position; a second grasping element movable relative to the second fixation element between the first position and the second position; and a central portion. The system also includes a delivery device comprising a catheter. The catheter has a proximal end and a distal end, and defines at least one lumen extending between the proximal end and the distal end. The delivery device also includes a shaft extending through the lumen and releasably coupled to the central portion. Furthermore, the system includes a first optical coherence tomography (“OCT”) catheter configured for cardiovascular imaging and including a first imaging probe. The first imaging probe includes a first end, a second end, and a first lens assembly disposed at the second end of the first imaging probe. The first imaging probe is configured to transmit light between a first end and a second end of the first imaging probe. In the assembled state of the fixation system, the first imaging probe extends through at least one lumen and extends from a second end of the shaft, such that a first lens assembly is positioned between a first lateral range and a second lateral range of the fixation device.

[0016] Additionally, the first imaging probe may include a sheath and an optical fiber disposed within the sheath. The optical fiber is rotatable and translatable within the sheath. Furthermore, the first lens assembly may include a lens and a beam deflector. The first lens assembly may be disposed at the end of the optical fiber. The beam deflector may be configured to deflect light transmitted through the first imaging probe in a radially outward direction from the central axis of the imaging probe. The beam deflector may also be configured to deflect the light at a perpendicular angle relative to the central axis.

[0017] Furthermore, the delivery device may include a handle that can be connected to a first end of the shaft. The handle may have an OCT probe engagement configured to receive and guide a first imaging probe into a lumen of the shaft. Additionally, the delivery device may include a fixation control element that extends through at least one lumen from a second end of the shaft, at which the fixation control element may engage one of a central portion, a first gripping element, and a second gripping element. The fixation control element may be an actuator rod configured to move a fixation element from a first position to a second position. The fixation control element may also be a gripping element line configured to move either the first or second gripping element from a first position to a second position.

[0018] Continuing the example, the first plane and the second plane may each bisect the central portion. The first plane may be orthogonal to the second plane and may intersect with the first clamping element and the second clamping element. The second plane may be positioned equidistant from each of the first clamping element and the second clamping element. The first lens assembly may be positioned adjacent to the central portion such that the first plane intersects with the first lens assembly. Alternatively, the first lens assembly may be positioned adjacent to the central portion such that the second plane intersects with the first lens assembly. The first plane and the second plane may define four quadrants arranged around the central portion. In another alternative, the first lens assembly may be positioned adjacent to the central portion and located in one of the four quadrants. The first imaging probe may also extend distally and proximally along the central portion into the space between the first gripping element and the first fixing element, such that the first lens assembly is positioned within this space. The first fixing element may include a crossbar that may extend across at least a portion of the engagement surface of the first fixing element. The first imaging probe may extend between the crossbar and the engagement surface, and the first lens assembly may be positioned at either the proximal or distal end of the crossbar.

[0019] Additionally, the first imaging probe may extend distally along the central portion and proximally along the proximal side of the first gripping element. The first imaging probe may be connected to a first side of the first gripping element.

[0020] The system may also include a second OCT catheter having a second imaging probe and a second lens assembly. The second imaging probe may extend from the axis of the delivery device, such that the second lens assembly can be positioned between a first lateral range and a second lateral range. Attached Figure Description

[0021] The features, aspects, and advantages of the invention will become more readily understood from the following description, the appended claims, and the accompanying drawings, in which:

[0022] Figure 1The illustration shows a partial cross-sectional view of the left ventricle and left atrium of the heart during ventricular systole;

[0023] Figure 2A The illustration shows the free edge of the mitral valve leaflet during normal closure, and... Figure 2B The diagram illustrates the free edge during the backflow engagement.

[0024] Figures 3A to 3C The illustrations show the process of holding the leaflet with a fixing device, inverting the distal component of the fixing device, and removing the fixing device.

[0025] Figure 4 The illustration shows an example of the fixing device in the desired orientation relative to the leaflet;

[0026] Figures 5A to 5B , Figures 6A to 6B An exemplary coupling mechanism for attaching a fixation device to a shaft of a delivery catheter is illustrated;

[0027] Figure 7 An exemplary fastening device for connecting to a shaft is illustrated;

[0028] Figures 8A to 8B , Figures 9A to 9B , Figures 10A to 10B , Figures 11A to 11B as well as Figures 12 to 14 The illustration shows fixation devices in various example positions during the introduction and placement of the device inside the body to perform a therapeutic procedure;

[0029] Figures 15A to 15C The illustration shows a cover on a fixing device, which is in various positions;

[0030] Figure 16 The diagram illustrates a fixing device including a proximal element and a locking mechanism;

[0031] Figure 17 yes Figure 16 A cross-sectional view of the locking mechanism;

[0032] Figures 18 to 19 These are cross-sectional views of the locking mechanism in the unlocked and locked positions, respectively.

[0033] Figure 20A and Figure 20B It is a schematic insertion force diagram along the proximal and distal elements of the first and second fixing devices, which have different lengths, respectively;

[0034] Figure 21A This is a schematic diagram of an example of an OCT catheter system;

[0035] Figure 21B yes Figure 21AA partial cross-sectional view of the OCT probe of the OCT catheter system;

[0036] Figure 22A A perspective view of an embodiment of a delivery catheter for a fixation device is shown.

[0037] Figure 22B It is along Figure 22A A cross-sectional view of line BB;

[0038] Figure 23 This is a perspective view of an example of a multi-catheter guidance system according to embodiments of the present disclosure, wherein, Figure 22A The delivery catheter axis is positioned to pass through the multi-catheter guidance system;

[0039] Figure 24A This is a perspective view of an example of an OCT probe centrally positioned relative to a fixed device with a covering.

[0040] Figure 24B and Figure 24C They are Figure 24A A perspective view and a front view of the arrangement of the OCT probe and fixation device, wherein the fixation device is shown without a cover;

[0041] Figure 24D It is by Figure 24C The line DD represents the portion cut at the 50% leaflet insertion point. Figure 24A A cross-sectional schematic diagram of the OCT probe and fixing device arrangement structure;

[0042] Figure 24E yes Figure 24A A schematic diagram of the OCT probe and fixation device arrangement, in which the valve leaflet is inserted into the fixation device;

[0043] Figure 24F It was taken at the 50% leaflet insertion point. Figure 24E Cross-sectional OCT images of the valve leaflet insertion;

[0044] Figure 25 This is a schematic diagram of a cross-section taken at the 50% leaflet insertion position of an OCT probe positioned in another central location relative to the fixing device.

[0045] Figure 26 This is a schematic diagram of a cross-section taken at the 50% leaflet insertion position of the first and second OCT probes, which are centrally positioned relative to the fixing device.

[0046] Figure 27A This is a front view of the first and second OCT probes, which are arranged in another central position relative to the fixed device.

[0047] Figure 27B Is in Figure 27A A schematic diagram of the cross-section of the first and second OCT probes arranged in the center at the 50% leaflet insertion position;

[0048] Figure 28 This is a schematic diagram of a cross-section taken at the 50% leaflet insertion position by the first and second OCT probes, which are arranged in another central position.

[0049] Figure 29 This is a schematic diagram of a cross-section taken by the first and second OCT probes, which are arranged in another central position, at the 50% leaflet insertion position.

[0050] Figure 30A This is a front view of an example of a fixing device with a central spacer that houses the OCT probe and actuator rod;

[0051] Figure 30B It is along Figure 30A A cross-sectional view of the central spacer taken from line BB;

[0052] Figure 31A It is a perspective view of the first and second OCT probes, which are positioned in a clamping arrangement relative to a fixing device with a cover and are located within the corresponding distal element of the fixing device.

[0053] Figure 31B yes Figure 31A A perspective view of the clamping arrangement, wherein the fixing device is shown without a cover;

[0054] Figure 31C Is in Figure 31A A schematic diagram of the cross-section of the first and second OCT probes in the clamping arrangement at the 50% leaflet insertion position;

[0055] Figure 31D It is connected to Figure 31A A perspective view of the first OCT probe, which is positioned relative to the crossbar of the first distal element of the fixing device and in the first lens arrangement.

[0056] Figure 32 It is connected to Figure 31A A perspective view of the first distal element of the fixing device and the second OCT probe arranged in the second lens relative to the crossbar of the first element;

[0057] Figure 33 It is connected to Figure 31A A perspective view of the first OCT probe, which is positioned relative to the crossbar of the first distal element of the fixing device and arranged in a third lens configuration.

[0058] Figure 34A This is a front view of the first and second OCT probes, which are in a different clamping arrangement relative to the fixation device and located within the respective proximal elements of the fixation device.

[0059] Figure 34B Is in Figure 34A A schematic diagram of a cross-section taken at the 50% leaflet insertion position of the first and second OCT probes in the clamping arrangement; and

[0060] Figure 35 The illustration shows an example of a mitral valve surgery in which the OCT probe remains positioned within the first fixation device while the second fixation device is implanted. Detailed Implementation I. Introduction

[0061] Percutaneous edge-to-edge valve repair, whether mitral or tricuspid, is typically performed under transesophageal echocardiography (TEE) guidance using a fixation device, with varying degrees of success. TEE is a specialized imaging technique that uses ultrasound to obtain detailed images of the heart and its structures. In edge-to-edge valve repair, the TEE probe, also known as a transducer, is inserted into the esophagus, located posterior to and adjacent to the heart. From the esophagus, the TEE probe uses high-frequency sound waves to generate real-time two-dimensional cross-sectional views and three-dimensional frontal views of the target valve being repaired. The surgeon uses these views to guide the fixation device to the target valve and orient it relative to the commissural line between the opposing leaflets in the desired orientation.

[0062] However, considerable difficulty arises when it comes to capturing valve leaflets using a fixation device, as TEE is suboptimal for assessing the quality of the grasped leaflet tissue and the adequacy of leaflet capture. In this regard, surgeons typically use color Doppler to observe changes in leaflet motion during diastolic / systolic cycles (e.g., leaflet flail or leaflet absence) and reduced reflux into the associated atrium to estimate that one or more leaflets have been captured just before the device is released into the heart. However, this is only an estimate and heavily reliant on the surgeon's experience using suboptimal imaging. The suboptimal nature of TEE for assessing leaflet capture is even more pronounced when performing edge-to-edge repair on the tricuspid valve. Located in the anterior mediastinum, the tricuspid valve is relatively far from the standard mid-esophageal position of the TEE probe compared to the mitral valve, potentially resulting in lower image quality for assessment based on it.

[0063] Therefore, a substantial challenge remaining for percutaneous edge-to-edge valve repair is ensuring that high-quality leaflet tissue has been adequately grasped and captured within the implantable fixation device. Specifically, when leaflet insertion into the device is insufficient on either side of the device, there is an increased chance of leaflet slippage from one side of the device (single leaflet device attachment, SLDA) or an increased chance of both leaflets slipping from both sides of the device (device occlusion). Even without leaflet dissociation, inadequate leaflet insertion can lead to insufficient leaflet access and residual valve regurgitation, resulting in adverse patient outcomes. Adding to this problem is the current inability to adequately assess the quality of the captured tissue, as calcification and other structural issues at the grasping site may reduce the quality of tissue that could otherwise be adequately captured or may indicate that device implantation is entirely contraindicated.

[0064] Alternatives to address the current difficulties in leaflet capture have been envisioned, but they offer only minor improvements and introduce additional complications. For example, U.S. Patent No. 8,758,393 describes a suturing device for suturing an artificial chordae tendineae to a valve leaflet. This suturing device uses a bundle of optical fibers to separate blood from the valve leaflet between grippers used to shuttle the suture needle through the tissue.

[0065] In another example, U.S. Patent No. 7,635,329 describes a valve fixation device having an embedded sensor for determining the presence or absence of tissue within the device. The described sensor may be in the form of a conductor, strain gauge, radio sensor, optical sensor, ultrasound sensor, infrared sensor, resistive sensor, intravascular ultrasound sensor, pressure sensor, or resonant sensor responsive to magnetic energy.

[0066] While the devices described in these examples may differ, the information generated by each of these devices is typically in binary form, simply indicating the presence or absence of tissue in general space, and not necessarily indicating the length of tissue within the device, nor identifying defects such as tissue quality defects or other structural problems. Ultimately, the surgeon lacks good visualization and must rely on the techniques previously described regarding TEE to assess the quality of the grasp and the quality of the tissue itself. Furthermore, the devices envisioned by the foregoing examples often require a large footprint within the already limited space of a percutaneously delivered fixation device and may necessitate positioning the electrically active components within the electrically active heart, which is generally undesirable.

[0067] The following exemplary devices, systems, and methods address the problems and limitations associated with the prior art. While some descriptions in the following discussion of such exemplary devices, systems, and methods may apply to the treatment of mitral regurgitation, it should be understood that such discussion of exemplary devices, systems, and methods is also applicable to the treatment of tricuspid regurgitation. A. Cardiac Physiology

[0068] Figure 1 The diagram illustrates the left ventricle (LV) of a normal heart during ventricular contraction. The left ventricle (LV) contracts, and blood flows outward through the aortic valve (AV) in the direction of the arrow. Because the mitral valve is designed as a "check valve" to prevent backflow when the pressure in the left ventricle is higher than the pressure in the left atrium (LA), it prevents blood from flowing back or "regurgitating" through the mitral valve (MV). Figure 1 As illustrated, the mitral valve (MV) comprises a pair of leaflets with free edges (FE) that are uniformly joined together for closure. The opposite ends of the leaflets (LF) attach to surrounding cardiac structures along an annular region known as the valve annulus (AN). The free edges (FE) of the leaflets (LF) are secured to the lower portion of the left ventricle (LV) by chordae tendineae (CT) (hereinafter referred to as tendons), which consist of multiple branching tendons fixed to the lower surface of each leaflet within the valvular leaflet (LF). The chordae tendineae (CT) are further attached to the papillary muscles (PM) extending upward from the lower portion of the left ventricle, and to the ventricular septum (IVS).

[0069] Many structural defects in the heart can lead to mitral regurgitation. Regurgitation occurs when the valve leaflets do not close properly, allowing leakage from the ventricles to the atria. Figure 2A As shown, the free edges of the anterior lobule (LF) and posterior lobule (LF) typically meet along the suture line (C). Examples of defects leading to backflow are shown in... Figure 2B As shown in the diagram, the enlargement of the heart here causes the mitral valve annulus to enlarge, preventing the free edges (FE) from engaging during cardiac contraction. This results in a gap (G) that allows blood to leak through the valve during ventricular contraction. A ruptured or elongated tendon can also cause leaflet prolapse, as insufficient tension is transmitted to the leaflet via the tendon. When the other leaflet maintains its normal contour, the two leaflets do not engage properly, and leakage occurs from the left ventricle to the left atrium. This regurgitation can also occur in patients with ischemic heart disease, where the left ventricle does not contract sufficiently to achieve proper closure. II. General Overview of Valve Fixation Techniques

[0070] Fixation devices are used to grasp, access, and stabilize tissues such as valve leaflets to treat valvular regurgitation, particularly mitral regurgitation, and to a lesser extent, tricuspid regurgitation. Fixation devices also offer the feature of allowing repositioning and removal when desired, especially in areas where removal might be obstructed by anatomical features such as chordae tendineae. If necessary, this removal will allow the surgeon to re-access the valve in a new manner.

[0071] The grasping will preferably be non-invasive, thus providing several benefits. Non-invasive means that the device and method can be applied to the valve leaflet and then removed without causing any apparent clinical damage to the leaflet structure or function. The leaflet and valve continue to function substantially the same as before the application of the fixation device. Therefore, some minor perforation or indentation of the leaflet may occur with the device, but it still meets the definition of "non-invasive." Similarly, a small portion of the leaflet may be cut around the edge of the fixation device during disabling or removal. This non-invasive installation, disabling, or removal allows the device to be applied to diseased valves and, if necessary, removed or repositioned without negatively impacting valve function. Additionally, it will be understood that in some cases, it may be necessary or desirable to puncture or otherwise permanently affect the leaflet during grasping, fixation, and / or removal. In some cases, grasping and fixation can be accomplished with a single device.

[0072] Fixation devices can rely on the use of interventional instruments, which are positioned near the desired treatment site and used to grasp the target tissue. In endovascular applications, the interventional instrument is typically an interventional catheter. In surgical applications, the interventional instrument is typically an interventional device. The grasped tissue is secured by using the interventional instrument as part of the implant to maintain the grasp. Fixation devices are particularly suitable for valve repair, especially heart valves such as the mitral valve.

[0073] See also Figure 3A , Figure 3A An example of an interventional tool 10 with delivery devices such as shaft 12 and fixation device 14 is illustrated, which is shown approaching the mitral valve MV from the atrial side and grasping the leaflet LF. As mentioned above, the mitral valve can be accessed surgically or by using endovascular techniques, or by a retrograde method via the ventricle or an antegrade method via the atrium. For illustrative purposes, an antegrade method is described.

[0074] The fixation device 14 is releasably attached to the shaft 12 of the interventional tool 10 at its distal end. When describing the device of the invention herein, “proximal” should mean the direction toward the end of the device to be manipulated by a user outside the patient's body, and “distal” should mean the direction toward the working end of the device located at the treatment site and away from the user. For the mitral valve, proximal should refer to the atrial or upstream side of the valve leaflet, and distal should refer to the ventricular or downstream side of the valve leaflet.

[0075] The fixation device 14 typically includes a proximal element 16 (or grasping element) and a distal element 18 (or fixation element), which project radially outward and are positioned on opposite sides of the lobule LF as shown to capture or retain the lobule between the proximal element 16 and the distal element 18. The combination of a proximal element 16 and a distal element is referred to herein as a clamp or gripper because such features operate together to clamp, hold, hold, or otherwise grasp tissue, as explained in further detail below. The proximal element 16 preferably comprises cobalt-chromium, nitinol, or stainless steel, and the distal element 18 preferably comprises cobalt-chromium or stainless steel; however, any suitable material may be used. The fixation device 14 is connectable to the shaft 12 via a coupling mechanism 17. The coupling mechanism 17 allows the fixation device 14 to disengage and remain as an implant to retain the lobule together in an occlusal position.

[0076] In some cases, it may be necessary to reposition or remove the fixation device 14 after the proximal element 16, the distal element 18, or both have been deployed to capture the leaflet LF. Such repositioning or removal may be required for a variety of reasons, such as re-approaching the valve to attempt to achieve better valve function, to more optimally position the device 14 on the leaflet, to better grip the leaflet, to disentangle the device 14 from surrounding tissues such as tendons, to replace the device 14 with a device of a different design, or to abort the fixation process, to name a few. To facilitate the repositioning or removal of the fixation device 14, the distal element 18 may be released and optionally inverted to a configuration suitable for withdrawing the device 14 from the valve without entanglement, interference, or damage to tendons, leaflets, or other tissues. According to another embodiment, any of the endovascular methods described herein for disabling or removing a fixation device may also be used.

[0077] Now refer to another source Figure 3B The diagram illustrates an inverted position, where the distal element 18 can be moved to the inverted position in the direction of arrow 40. Similarly, the proximal element 16 can be raised if desired. In the inverted position, the device 14 can be repositioned to the desired orientation, wherein the distal element can then be restored to its original position. Figure 3A The gripping position against the leaflet is shown in the diagram. Alternatively, the fixing device 14 can be as follows: Figure 3C The device 14 is withdrawn from the leaflet (indicated by arrow 42). This inversion reduces damage to the leaflet and minimizes any entanglement of the device with surrounding tissue. Once the device 14 has been withdrawn through the valve leaflet, the proximal and distal elements can be moved to a closed position or configuration suitable for removal from the body or reinsertion via the mitral valve.

[0078] Now refer to another source Figure 4 The illustration shows an example position of the fixation device 14 relative to the leaflet LF in the desired orientation. This is a short-axis view of the mitral valve MV viewed from the atrial side; therefore, the proximal element 16 is shown in solid lines and the distal element 18 in dashed lines. According to an example of this disclosure, the proximal element 16 and the distal element 18 are positioned substantially perpendicular to the occlusal line C. In one example, the device 14 can be moved substantially along the occlusal line to the regurgitation position. The leaflet LF is held in place such that during ventricular diastole, as... Figure 4 As shown, the leaflet LF is held in a position between elements 16 and 18, surrounded by an opening or orifice O generated by the diastolic pressure gradient of the heart. Advantageously, the leaflet LF is anastomosed such that the proximal or upstream surfaces of the leaflet LF face each other in a vertical orientation parallel to the direction of blood flow through the mitral valve MV. According to examples of this disclosure, the upstream surfaces may come together to contact each other or may remain slightly separated, but will preferably be held in a vertical orientation in which the upstream surfaces face each other at the occlusion point. This mimics the dual-orifice geometry of a standard surgical bowtie repair. As discussed further below, the adequacy of the leaflet capture by the fixation device 14 can be evaluated. If desired or otherwise desired, one or more leaflets can be released and re-captured until optimal results are achieved, in which the leaflet LF is held in place and regurgitation is substantially reduced.

[0079] Once the leaflets are aligned in the desired arrangement, the fixation device 14 is then detached from the shaft 12 and remains as an implant to hold the leaflets together in the aligned position. As described above, in some examples, the fixation device 14 is connected to the shaft 12 via a coupling mechanism 17. Figures 5A to 5B , Figures 6A to 6B An example of this connecting mechanism is illustrated. Figure 5A An upper shaft 20 and a detachable lower shaft 22 are shown interlocking at the mating line or mating surface 24. The mating surface 24 may have any shape or curvature that allows or facilitates interlocking and subsequent separation. As shown, a tightly fitting outer sheath 26 is positioned on the shafts 20, 22 to cover the mating surface 24. Figure 5B The illustration shows the separation of the lower shaft 22 from the upper shaft 20 according to various examples. In this example, this can be achieved by retracting the outer sheath 26, exposing the mating surface 24, thereby allowing the shafts 20 and 22 to separate.

[0080] Now refer to another source Figure 6A Similarly, the diagram illustrates a tubular upper shaft 28 and a detachable tubular lower shaft 30 interlocking at mating surfaces 32. Likewise, mating surfaces 32 can have any shape or curvature that will allow or facilitate interlocking and subsequent separation. In one example, the tubular upper shaft 28 and tubular lower shaft 30 form an outer member with an axial channel. As shown, a tightly fitted rod 34 or inner member is inserted through the tubular shafts 28, 30 to bridge the mating surfaces 32. Figure 6B The diagram illustrates the separation of the lower shaft 30 from the upper shaft 28. According to an example of this disclosure, this is achieved by retracting the rod 34 to a position above the mating surface 32, which in turn allows the shafts 28 and 30 to separate.

[0081] In one example, mating surface 24 (or mating surface 32) is an S-curve defining a convex element and a concave element on the upper shaft 20 (or upper shaft 28), which interlock with corresponding concave and convex elements on the lower shaft 22 (or lower shaft 30), respectively. In one example, the lower shaft is the coupling mechanism 17 of the fixing device 14. Therefore, the shape of the selected mating surface will preferably provide at least some mating surfaces transverse to the axial axis of the mechanism 19 to facilitate the application of compressive and tensile forces to the fixing device 14 by the coupling mechanism 17, while minimizing disturbance when the fixing device 14 is to be released from the upper shaft. It will be understood that these coupling mechanisms are exemplary, and other coupling mechanisms may also be used. A. Exemplary fixing device

[0082] Also refer to Figure 7The illustration depicts an exemplary fixation device 14. Here, fixation device 14 is shown coupled to shaft 12 to form interventional tool 10. Fixation device 14 includes a coupling member 19 and a pair of opposing distal elements 18. The distal elements 18 include elongated arms 53, each arm having a proximal end 52 rotatably connected to the coupling member 19 and a free end 54. The free end 54 has a rounded shape to minimize disturbance and trauma to surrounding tissue structures. Preferably, each free end 54 defines a curvature about two axes, one of which is an axis 66 perpendicular to the longitudinal axis of the arm 53. Thus, the engagement surface 50 has a cup-shaped or concave shape for the surface area in contact with tissue and helps to grasp and retain the valve leaflet. This further allows the arm 53 to nest around shaft 12 in a closed position to minimize the profile of the device. Preferably, the arm 53 is at least partially cup-shaped or curved inward about its longitudinal axis 66. Similarly, preferably, each free end 54 defines a curvature about an axis 67 perpendicular to axis 66 or the longitudinal axis of the arm 53. This curvature is the reverse curvature along the distal portion of the free end 54. Similarly, in some examples, the longitudinal edge of the free end 54 may flare outward. Both the reverse curvature and the flare minimize trauma to the tissue engaging with the free end.

[0083] According to various non-limiting examples, for applicability to mitral valve repair, the lateral width across the abutment surface 50 (which determines the width of the abutted tissue) can be at least about 2 mm, typically 3 mm to 10 mm, and preferably about 4 mm to 6 mm. In some cases, a wider abutment is desired, wherein the abutment surface 50 is larger, for example, about 2 cm, or multiple fixation devices are used adjacent to each other. In some examples, the arm 53 and the abutment surface 50 are configured to abut a tissue length of about 4 mm to 10 mm, and preferably about 6 mm to 8 mm, along the longitudinal axis of the arm 53. In various examples, the arm 53 also includes multiple openings to enhance gripping and promote inward tissue growth after implantation.

[0084] The valve leaflet is held between the distal element 18 and the proximal element 16. In some examples, the proximal element 16 may be flexible, elastic, and suspended from the connecting member 19. The proximal element is preferably elastically biased toward the distal element. In one example, each proximal element 16 is shaped and positioned to be at least partially recessed within the concave portion of the distal element 18 in the absence of tissue. According to one example, when the fixation device 14 is in the open position, the proximal elements 16 are shaped such that each proximal element 16 is separated from the engagement surface 50 near the proximal end 52 of the arm 53 and inclined toward the engagement surface 50 near the free end 54, wherein the free end of the proximal element contacts the engagement surface 50, as shown below. Figure 7As illustrated in the figure. This shape of the proximal element 16 is adapted to valve leaflets or other tissues of varying thicknesses.

[0085] In various examples, the proximal element 16 includes a plurality of openings 63 and fan-shaped side edges 61 to increase gripping of the tissue. The proximal element 16 may optionally include friction attachments, friction features, or gripping enhancement elements to assist in gripping and / or retaining the leaflet. Friction attachments may include, for example, teeth or barbs 60 having tapered tips extending toward the mating surface 50. Any suitable friction attachment may be used, such as forks, coils, strips, barbs, grooves, channels, bumps, surface roughening, sintered portions, high-friction pads, coverings, coatings, or combinations thereof. Optionally, magnets may be present in the proximal and / or distal elements. It is understood that the mating surfaces may be made of or may include materials with opposite magnetic charges to generate an attractive force through magnetic force. For example, the proximal and distal elements may each include magnetic materials with opposite charges, such that the tissue is held between the proximal and distal elements under constant compression to promote faster tissue healing and inward growth. In addition to biasing the proximal element toward the distal element, or as an alternative, magnetic force can be used to pull the proximal element 16 toward the distal element 18. This can facilitate the unfolding of the proximal element 16. In another example, each of the distal elements 18 comprises a magnetic material with opposite charges, such that tissue positioned between the distal elements 18 is held between the distal elements 18 by magnetic force.

[0086] The proximal element 16 may be covered with a fabric or other flexible material as described below to enhance post-implantation grip and tissue inward growth. Preferably, when the fabric or covering is used in combination with barbs or other friction features, these features will protrude through the fabric or covering to access any tissue engaged by the proximal element 16.

[0087] In various examples, the proximal element 16 may be formed from a sheet of spring-like material using a stamping operation that produces an opening 63, a fan-shaped edge 61, and a barb 60. Alternatively, the proximal element 16 may comprise a spring-like material or be molded from a biocompatible polymer. Some types of friction attachments may permanently alter or cause some trauma to the tissue thereby joined, while other friction attachments will be non-invasive and will not cause clinically significant harm or otherwise affect the tissue. For example, in the case of the barb 60, it has been demonstrated that after engagement of the mitral valve leaflet by the fixation device 14, if the device is later removed during the procedure, the barb 60 will not leave significant permanent scarring or other damage to the leaflet tissue, and therefore the barb 60 is considered non-invasive.

[0088] In various examples, the fixing device 14 also includes an actuation mechanism 58. In some examples, the actuation mechanism 58 includes two linkage members or legs 68, each leg 68 having a first end 70 and a second end 72, the first end 70 being rotatably connected to one of the distal elements 18 at a riveted joint 76, and the second end 72 being rotatably connected to a stud 74. The legs 68 are preferably made of rigid or semi-rigid metals or polymers such as Elgiloy®, cobalt chromium, or stainless steel; however, any suitable material may be used. Although in the illustrated device both legs 68 are pinned to the stud 74 by a single rivet 78, it will be understood that each leg 68 may be individually attached to the stud 74 by a separate rivet or pin. The stud 74 can be connected to an actuator rod 64 (not shown) that extends through the shaft 12 and is axially extendable and retractable to move the stud 74 and thus the leg 68, thereby rotating the distal element 18 between a closed position, an open position, and an inverted position. Similarly, the retention of the stud 74 holds the leg 68 in place and thus holds the distal element 18 in the desired position. The stud 74 can also be locked in place by a locking feature, which will be described further in a later section.

[0089] In some examples, some mobility or flexibility may exist in the distal element 18 and / or proximal element 16 of the fixation device 14 in the closed position, allowing these elements to move or bend as the valve leaflets open or close. This provides shock absorption and thereby reduces the force on the leaflets and minimizes the possibility of leaflet tearing or other trauma. This mobility or flexibility can be provided by constructing the distal element 18 using a flexible, elastic metal or polymer of appropriate thickness. Furthermore, in some examples, the locking mechanism of the fixation device (described below) may be made of a flexible material to allow some slight movement of the proximal and distal elements, even when locked. Additionally, in some examples, the distal element 18 may be connected to the coupling mechanism 19 or actuation mechanism 58 via a mechanism that biases the distal element to the closed position (inward) but allows the arm to open slightly in response to the force exerted by the leaflets. For example, these components may be pinned via a slot rather than at a single point, the slot allowing the pin to translate slightly in response to the force against the arm. A spring may be used to bias the pinned component toward one end of the slot.

[0090] See also Figures 8A to 8B , Figures 9A to 9B , Figures 10A to 10B , Figures 11A to 11B and Figures 12 to 14 The illustration shows the process of introducing and placing the device 14 into the body to perform a treatment procedure. Figure 7 Various possible positions of the fixing device 14. Figure 8AAn example of an interventional tool 10 delivered via catheter 86 is illustrated. It should be understood that the interventional tool 10 may take the form of a catheter, and similarly, the catheter 86 may take the form of a guiding tube or a sheath. However, in this example, the terms interventional tool 10 and catheter 86 will be used. The interventional tool 10 includes a fixation device 14 coupled to shaft 12, and the fixation device 14 is shown in a closed position. Figure 8B A larger view illustrates the relationship with Figure 8A This is a similar device. In the closed position, a pair of opposing distal elements 18 are positioned such that the engagement surfaces 50 face each other. Each distal element 18 includes an elongated arm 53 having a cup-shaped or concave shape, such that the arms 53 together surround the shaft 12 and optionally contact each other on opposite sides of the shaft. This provides a small profile for the fixation device 14, which can easily pass through the catheter 86 and associated anatomical structures such as the mitral valve. Additionally, Figure 8B An example of an actuation mechanism 58 is also shown. The actuation mechanism 58 includes two legs 68, each movably coupled to a base 69. In one example, the base 69 is connected to an actuator rod 64 extending through the shaft 12 and used to manipulate the fixing device 14 (see [link to example]). Figure 10B The actuator rod 64 can be directly attached to the actuation mechanism 58, and particularly to the base 69. Alternatively, the actuator rod 64 can be attached to a stud 74, which in turn is attached to the base 69. The stud 74 can be threaded, allowing the actuator rod 64 to be attached to it via a helical action. However, the rod 64 and the stud 74 can be connected by any releasable mechanism to allow the retaining device 14 to be separated from the shaft 12.

[0091] See also Figures 9A to 9B The illustration shows the retaining device 14 in the open position. According to an example of this disclosure, in the open position, the distal element 18 is rotated such that the engagement surface 50 faces a first direction. For example, by the action of the actuator rod 64, the stud 74 is advanced relative to the distal end of the connecting member 19, applying force to the distal element 18, which begins to rotate about the engagement portion 76 due to its degree of freedom of movement in that direction. This radially outward rotation and movement of the distal element 18 causes the leg 68 to rotate about the engagement portion 80, such that the leg 68 is slightly oriented outward. The stud 74 can be advanced to any desired distance related to the desired spacing of the distal element 18. In the open position, the engagement surfaces 50 are arranged at an acute angle relative to the axis 12, and preferably at an angle between 90 and 180 degrees relative to each other. In various examples of the open position, the span between the free ends 54 of the arms 53 can be about 10 mm to 20 mm, typically about 12 mm to 18 mm, and preferably about 14 mm to 16 mm.

[0092] In one example, the proximal element 16 is biased outward toward arm 53. In some examples, the proximal element 16 may be moved inward toward and held against axis 12 by means of a proximal element line 90 in the form of a suture, thread, nitinol wire, rod, cable, polymer wire, or other suitable structure. The proximal element line 90 can be connected to the proximal element 16 by passing the line 90 through it in various ways, which allows the proximal element 16 to move together and / or independently toward or away from the corresponding distal element 18 by tension or slack of the line 90. Figure 9A As shown in the example, when the proximal element 16 has a loop shape, the line 90 can pass through the loop and fold back. (As...) Figure 9B As shown in the example, when the proximal element 16 has an elongated solid shape, the line 90 can pass through one or more openings 63 in element 16. Furthermore, as also... Figure 9B As illustrated, a loop 48 may be present on the proximal element 16, through which the proximal element line 90 may pass and fold back. This loop 48 can be used to reduce friction on the proximal element line 90, or to attach the proximal element line 90 when the proximal element 16 is solid or has no other loops or openings. The proximal element line 90 may be attached to the proximal element 16 via a detachable device that allows a single line 90 to be attached to the proximal element 16 without folding back and allows a single line 90 to be directly detached from the proximal element 16 when needed. Examples of such detachable devices include hooks, loops, clamps, or fragile couplings, to name a few.

[0093] By applying sufficient tension to the proximal element line 90, the detachable device can be separated from the proximal element 16, for example, by the breakage of the coupling. Other mechanisms for disassembly can also be used. Similarly, locking line 92 ( Figure 16 It can be attached to and detached from the locking mechanism via a similar detachable device.

[0094] In the open position, the fixation device 14 can engage the tissue to be approached or treated. According to one example of this disclosure, Figures 7 to 9B The apparatus illustrated is suitable for repairing the mitral valve using an antegrade approach from the left atrium. The interventional tool 10 is advanced from the left atrium through the mitral valve into the left ventricle. The distal element 18 is oriented perpendicular to the chastity line and then positioned such that the engagement surface 50 contacts the ventricular surface of the valve leaflet, thereby grasping the leaflet. The proximal element 16 is held on the atrial side of the valve leaflet, such that the leaflet is positioned between the proximal and distal elements. The proximal element 16 has friction attachments, such as barbs 60 oriented toward the distal element 18. However, in one example, neither the proximal element 16 nor the barbs 60 contacts the leaflet at this time.

[0095] The intervention tool 10 can be repeatedly manipulated to reposition the fixing device 14 so that the leaflet is properly contacted or grasped at the desired location. Repositioning is achieved using the fixing device in the open position. In some cases, backflow can also be checked while the device 14 is in the open position. If the backflow is not satisfactorily reduced, the device can be repositioned and the backflow checked again until the desired result is obtained.

[0096] It is also desirable to invert the fixing device 14 to assist in the repositioning or removal of the fixing device 14. See also Figures 10A to 10B , Figures 10A to 10B The illustration shows an example of the fastening device 14 in an inverted position. By further advancing the stud 74 relative to the connecting member 19, the distal element 18 is further rotated such that the engagement surface 50 faces outward and the free end 54 points to the distal end, wherein each arm 53 forms an obtuse angle relative to the axis 12.

[0097] In various examples, when in the inverted position, the angle between the arms 53 is preferably in the range of about 270 to 360 degrees. Further advancement of the stud 74 causes the distal element 18 to rotate further about the junction 76. This radially outward rotation and movement of the distal element 18 causes the legs 68 to rotate about the junction 80, so that the legs 68 return to their initial position, which is generally parallel to each other. The stud 74 can be advanced to any desired distance associated with the desired inversion of the distal element 18. In some preferred examples, in the fully inverted position, the span between the free ends 54 does not exceed about 20 mm, is typically less than about 16 mm, and is most preferably about 12 to 14 mm. In this illustration, the proximal element 16 is held in position against the shaft 12 by applying tension on the proximal element line 90. Thus, a relatively large space can be created between the elements 16, 18 for repositioning. Additionally, the inverted position allows the fixation device 14 to be withdrawn through the valve while minimizing trauma to the leaflet. As the fixation device retracts proximally, the engagement surface 50 provides a non-traumatic surface for deflecting tissue. The barbs 60 are slightly angled in the distal direction (away from the free end of the proximal element 16), thereby reducing the risk that the barbs will snag or tear tissue when the fixation device is withdrawn.

[0098] Once the fixation device 14 has been positioned in the desired location against the valve leaflet, the leaflet can then be captured between the proximal element 16 and the distal element 18. Now refer to further details. Figures 11A to 11B The illustration shows an example of a fixing device 14 in this position. In this example, the proximal element 16 is lowered toward the engagement surface 50, such that the leaflet is held between the proximal element 16 and the engagement surface 50. Figure 11BIn the image, the proximal element 16 is shown including a barb 60, which can be used to provide non-invasive grasping of the lobule. Alternatively, larger, sharper barbs or other penetrating structures can be used to pierce the lobule to more aggressively assist in holding the lobule in place. This location is similar to... Figures 9A to 9B The proximal element 16 is now lowered toward the arm 53 by releasing tension on the proximal element line 90 to compress the lobular tissue between the proximal element 16 and the arm 53. At any time, if the backflow is not sufficiently reduced, the proximal element 16 can be raised and the distal element 18 can be adjusted or inverted to reposition the retaining device 14.

[0099] According to some examples of this disclosure, after the leaflet has been captured between the proximal element 16 and the distal element 18 in the desired arrangement, the distal element 18 can be locked to hold the leaflet in that position, or the fixing device 14 can return to or toward the closed position. Examples of such locking are described in later sections. See also... Figure 12 , Figure 12 The diagram illustrates the retaining device 14 in the closed position, where the leaflet (not shown) is captured and engaged. In one example, this is achieved by retracting the stud 74 proximally relative to the connecting member 19, causing the leg 68 of the actuating mechanism 58 to exert an upward force on the distal element 18, which in turn rotates the distal element 18 so that the engagement surfaces 50 face each other again. In some examples, the released proximal element 16, biased outward toward the distal element 18, is simultaneously pushed inward by the distal element 18. In various examples, the retaining device 14 can then be locked to hold the leaflet in this closed position, as described below.

[0100] Now refer to another source Figure 13 The fixing device 14 can then be released from the shaft 12. As mentioned, in various examples, the fixing device 14 can be releasably connected to the shaft 12 via the connecting member 19. Figure 13 The diagram illustrates a connection structure in which, according to one example, the connecting member 19 of the fixation device 14 is attached to a portion of the shaft 12. As shown, in one example, the proximal element line 90 can remain attached to the proximal element 16 after being separated from the shaft 12 to serve as a tether to maintain the connection between the fixation device 14 and the catheter 86. Alternatively, a separate tether connecting the shaft 12 and the fixation device 14 can be explicitly used for this purpose when the proximal element line 90 is removed. In any case, the repair of the lobule or tissue can be observed using non-invasive visualization techniques such as echocardiography to ensure the desired outcome. Then, if the repair is not as desired, the fixation device 14 can be retrieved using the tether or the proximal element line 90 to reconnect the connecting member 19 to the shaft 12.

[0101] In various examples, the proximal element line 90 may be an elongated, flexible thread, wire, cable, suture, or cord that extends through the shaft 12, loops through the proximal element 16, and extends back through the shaft 12 to the proximal end of the shaft 12. When separation is required, one end of each line may be released at the proximal end of the shaft 12, and the other end may be pulled to draw the free end of the line distally through the shaft 12 and the proximal element 16, thereby releasing the fastening device.

[0102] Now refer to another source Figure 14 The illustration shows an example of a released fixation device 14 in a closed position. As shown, the connecting member 19 remains separated from the shaft 12 of the intervention tool 10, and the proximal element 16 is deployed such that tissue (not shown) can be located between the proximal element 16 and the distal element 18.

[0103] Instead of using a push-open / pull-close mechanism to open and close the distal element 18, a pull-open / push-close mechanism can also be used in various examples. For example, the distal element 18 may be coupled to the stud 74 at its proximal end instead of to the connecting member 19, and the leg 68 may be coupled to the connecting member 19 at its proximal end instead of to the stud 74. In this example, when the stud 74 is pushed distally relative to the connecting member 19, the distal element 18 will close, while pulling the stud 74 proximally toward the connecting member 19 will open the distal element 18. B. Covers on the fixing device

[0104] The fixation device 14 may optionally include a covering. The covering may assist in tissue gripping and may subsequently provide a surface for tissue inward growth. Inward growth of surrounding tissue, such as valve leaflets, provides stability to the device 14 as the device 14 is further anchored in place and can be covered with natural tissue, thereby reducing the likelihood of an immune response. In various examples, the covering may comprise any biocompatible material, such as polyethylene terephthalate (PET), polyester, cotton, polyurethane, expanded polytetrafluoroethylene (ePTFE), silicone, or various polymers or fibers, and the covering may have any suitable form, such as fabric, mesh, textured braid, felt, loop, or porous structure. Typically, in some examples, the covering has a small profile so as not to interfere with delivery via the introducer sheath or with the gripping and occlusion of leaflets or tissue.

[0105] Now refer to another source Figures 15A to 15C The illustration shows an example cover 100 on the device 14 when the device 14 is in various positions. Additional description of such a cover can be found in PCT Publication No. WO 2004 / 103162, the contents of which are incorporated herein by reference in their entirety. C. Locking mechanism

[0106] As mentioned above, the fixing device 14 may optionally include a locking mechanism for locking the device 14 in a specific position, such as an open position, a closed position, or an inverted position, or any position between the open, closed, and inverted positions. It should be understood that the locking mechanism includes an unlocking mechanism that allows the device to be locked or unlocked. Various locking mechanisms can be used with the fixing device 14, such as the fixing device described in PCT Publication No. WO 2004 / 103162, which is incorporated herein by reference in its entirety. Reference is now also made to... Figures 16 to 19 The illustration depicts an exemplary locking mechanism 106. (Refer to...) Figure 16 In this example, a locking mechanism 106 is disposed between the connecting member 19 and the base 69 of the actuation mechanism 58. The base 69 is fixedly attached to a stud 74 extending through the locking mechanism 106. The stud 74 is releasably attached to an actuator rod 64 that passes through the connecting member 19 and the shaft 12 of the intervention tool 10. The base 69 is also connected to a leg 68 of the actuation mechanism 58, which in turn is connected to a distal element 18.

[0107] Figure 16 The diagram also illustrates a proximal element 16, which, according to this example, straddles the locking mechanism and is connected below the locking mechanism 106. The proximal element 16 is shown supported by a proximal element line 90. In this example, the proximal element 16 is raised and lowered by manipulating the proximal element line 90. Additionally, a locking line 92 is shown connected to a release harness 108 of the locking mechanism 106. The locking line 92 is used to lock and unlock the locking mechanism 106, as described below. The proximal element line 90 and the locking line 92 can comprise any suitable material, typically wire, nitinol wire, cable, suture, or thread, to name a few. Additionally, in some examples, the proximal element line 90 and / or the locking line 92 can comprise a coating, such as parylene. Parylene is a conformally conformal and biocompatible vapor-deposited, pinhole-free protective film. Parylene is inert and can be moisture-proof, chemical-proof, and charge-proof.

[0108] See also Figure 17 , Figure 17 Provided Figure 16The front view of the locking mechanism 106. However, in this example, the proximal element 16 is supported by a single proximal element line 90 passing through both proximal elements 16. In this arrangement, the two elements 16 are simultaneously raised and lowered by the action of the single proximal element line 90. Whether the proximal element 16 is operated individually by a single proximal element line 90 or jointly by a single proximal element line 90, the proximal element line 90 can extend directly through an opening in the proximal element and / or through a layer or portion of the covering 100 on the proximal element, or through a suture loop above or below the covering 100.

[0109] Now refer to another source Figures 18 to 19 The illustration shows the locking mechanism 106 in both the unlocked and locked positions. (See reference...) Figure 18 In various examples, the locking mechanism 106 includes one or more wedging elements, such as rolling elements. In this example, the rolling element includes a pair of barbell-shaped members 110 disposed on opposite sides of the stud 74, each barbell-shaped member having a pair of generally cylindrical caps and an axle located between the pair of generally cylindrical caps. The barbell-shaped members 110 and the stud 74 are preferably made of cobalt chromium or stainless steel; however, any suitable material can be used. In one example, the barbell-shaped members 110 are actuated by hook-shaped ends 112 of the release harness 108. Figure 18 As shown, when locked by line 92 ( Figure 16 (As illustrated in the diagram) When an upward force is applied to the harness 108, the hook-shaped end 112 causes the barbell-shaped member 110 to rise against the spring 114. In one example, this pulls the barbell-shaped member 110 upward along the sidewall or inclined surface 116, thereby removing the barbell-shaped member 110 from the stud 74. In this position, the stud 74 is free to move. Therefore, when the locking line 92 rises or lifts the harness 108, the locking mechanism 106 is in the unlocked position, where the stud 74 allows the actuation mechanism 58 to move freely, and thus allows the distal element 18 to move to any desired position. In various examples, such as Figure 19As illustrated, the locking mechanism 106 is switched to the locked position by releasing the harness 108 via the locking line 92. By releasing an upward force on the barbell-shaped member 110 from the hook-shaped end 112, the spring 114 forces the barbell-shaped member 110 downward and weds it between the inclined surface 116 and the stud 74. This restricts the movement of the stud 74, which in turn locks the actuation mechanism 58 into place and thus locks the distal element 18 into place. Alternatively, in one example, the stud 74 may include one or more grooves 82 or recesses that receive the barbell-shaped member 110. This provides a faster and more aggressive locking by fixing the barbell-shaped member 110 in a defined position, increases the stability of the locking feature by further preventing movement of the barbell-shaped member 110, and provides the user with a tangible indication that the barbell-shaped member has reached the locked position. Additionally, the grooves 82 can be used to indicate the relative positions of the distal elements 18, particularly the distance between the distal elements 18. For example, each groove 82 can be positioned to correspond to a reduction of 0.5 mm or 1.0 mm in the distance between the distal elements 18. As the stud 74 moves, the barbell-shaped member 110 contacts the groove 82; by calculating the number of grooves 82 felt as the stud 74 moves, the user can determine the distance between the distal elements 18 and can provide the desired degree of engagement based on leaflet thickness, geometry, spacing, hemodynamics, and other factors. Therefore, in various examples of this disclosure, the groove 82 can provide tactile feedback to the user.

[0110] The locking mechanism 106 allows the fixation device 14 to remain in the unlocked position during attachment to the interventional tool 10 during grasping and repositioning, and then in the locked position while left as an implant. However, it is understood that the locking mechanism 106 can be repeatedly locked and unlocked throughout the placement of the fixation device 14 if necessary. In various examples of this disclosure, once the final placement position is determined, the locking line 92 and the proximal element line 90 are removed and the fixation device is left in place. III. Fixation system with improved leaflet capture assessment A. Leaflet safety

[0111] As previously described, opposing leaflets can be captured between the respective proximal element 16 and distal element 18 to improve leaflet-to-leaflet fusion and reduce valvular regurgitation. However, simply capturing valve tissue between the proximal element 16 and distal element 18 is often insufficient. Instead, the valve tissue must be adequately secured to realize the benefits of the fixation device 14 and reduce or eliminate the possibility of SLDA and / or implant embolism. Leaflet safety is generally determined by the significance of leaflet quality and the clamping force applied to the tissue by the fixation device 14. Factors that may affect leaflet quality include, for example, leaflet thickness and the presence, amount, and / or distribution of calcification. Leaflets that are too thin may not be held under the force applied by the fixation device or may not be adequately clamped by the fixation device 12. Calcification may interfere with the fixation device's ability to hold the tissue and may damage the tissue during grasping.

[0112] Finite element analysis has been performed to quantify the clamping forces within the corresponding proximal element 16 and distal element 18 to determine the appropriate insertion depth of the leaflet between the proximal element 16 and distal element 18 to ensure leaflet safety. Figure 20A The force distribution resulting from this analysis of the first clamping member 51 (or first clamp 51) including the proximal element 16 and the distal element 18 is shown in the figure, and Figure 20B The force distribution resulting from this analysis of the second, longer clamping member 51' (or second clamp 51') including the proximal element 16' and the distal element 18' is shown. As illustrated, regardless of the length of the clamping members 51, 51', most of the clamping force generated is applied to the tissue when approximately 50% or more of the maximum leaflet insertion depth is reached. Therefore, leaflet safety is ensured, and leaflet capture is adequate when the leaflet is inserted between the proximal elements 16, 16' and the distal elements 18, 18' to a depth greater than 50% of the maximum insertion depth. Figure 20A and Figure 20B The maximum insertion depth L described in the text 抓持 This is the maximum length along which the leaflet can be captured between the proximal elements 16, 16' and the distal elements 18, 18'. Maximum insertion depth L 抓持Measurements can be taken between the crotch 13 (considering any fabric covering on the fastener 14) formed between the distal ends 52, 55 of the proximal elements 16, 16' and the free ends 54, 57 of the proximal elements 16, 16' and the distal elements 18, 18'. The crotch 13 defines the closed ends of the clamps 51 and 51'. The free ends 54 and 57 define the open ends of the clamps 51 and 51'. Although the proximal elements 16, 16' and the distal elements 18, 18' typically capture tissue at approximately 60 degrees (120 degrees relative to each other) relative to the longitudinal axis defined by the shaft 12 and then move to a final closed position of 5 to 15 degrees (10 to 30 degrees relative to each other), it should be noted that the clamping force generally does not vary with the angle of the clamps 51, 51' until the initial capture angle of approximately 60 degrees. Therefore, the clamping force will be approximately the same throughout the entire range of motion from the initial capture to the final closed position.

[0113] Although lobule safety is an important aspect of achieving positive results in edge-to-edge repair, surgeons currently lack sufficient tools to assess it. TEE is typically relied upon to determine if lobule capture has been achieved, but this assessment is usually based solely on the surgeon's experience observing lobule movement characteristics in captured and uncaptured states and on reduced reflux. TEE does not provide surgeons with the ability to accurately and directly determine lobule safety, and particularly the factors that help ensure it.

[0114] The following describes a fixation system with improved leaflet capture assessment. According to various examples of this disclosure, such a system typically includes a fixation device 14, an optical coherence tomography (“OCT”) catheter system 200, a delivery device 300, and a guide tube assembly 400. B. OCT catheter system

[0115] Now refer to another source Figure 21A and Figure 21B It depicts an OCT catheter system 200. In one example, the OCT catheter system 200 typically includes an OCT catheter 210 and an OCT subsystem 230.

[0116] OCT catheter or imaging catheter 210 is configured for cardiovascular imaging. OCT catheter 210 may include an imaging probe 212. OCT catheter 210 may also include a flushing feature 215. OCT catheter may also include a connector 216. Imaging probe 212 extends from connector 216. Imaging probe 212 includes an optical fiber 217 and a transparent sheath 219 surrounding the optical fiber 217. Optical fiber 217 is configured to transmit light between a proximal end and a distal end of optical fiber 217. Optical fiber 217 may be made of glass or a polymer material, preferably bendable or flexible. Optical fiber 217 is positioned within a lumen 218 of sheath 219 and is rotatable about the central axis CA of imaging probe 212 and translates relative to sheath 219 along the central axis CA of imaging probe 212. Figure 21B The directional arrows shown illustrate this. Alternatively, the optical fiber 217 can rotate within the sheath 219, but is restricted to longitudinal translation or any movement relative to the sheath 219 is completely restricted. The distal end of the imaging probe forms a probe tip 220, which includes a lens assembly 222. The lens assembly 222 is disposed at the end of the optical fiber and includes a microlens 223 configured to focus light traveling through the optical fiber 217 at a distance from the lens 223 and capture a portion of the light guided back toward the lens assembly 222 for image generation. The particular embodiment depicted is a lateral scanning imaging probe, such that the lens assembly 222 may also include a beam deflector 224, which may be a mirror offset distally from the lens assembly 222 and configured to deflect light 226 passing through the lens 223 radially outward at a vertical angle relative to the central axis CA. For example, in other embodiments, lens assembly 222 may be configured to project light 226 radially outward at an angle or multiple angles relative to the central axis CA, such as an angle and the previously mentioned vertical angle or multiple angles. In yet another embodiment, probe 212 may be a forward scanning probe, such that no deflector 224 is provided, and light 226 is emitted from a probe aligned with the central axis CA to the intended target. Lens assembly 222 may be formed separately and attached to optical fiber 217, or may be molded onto optical fiber 217.

[0117] The light transmitted via fiber optic cable 217 for generating OCT images is in the infrared spectrum. Therefore, red blood cells and other objects with a red hue tend to absorb this light. To help remove red blood cells away from the probe tip 220 during image capture and potentially improve image resolution, a saline flushing feature 214 can be incorporated into the catheter 210. However, the flushing feature 214 is optional and can be, for example, incorporated in other parts of the system, such as the delivery device 300 described below. The saline flushing feature 214 of the OCT catheter 210 includes a flushing inlet port 215 at the proximal end of the catheter 210 for introducing saline solution and one or more flushing outlet ports 226 located within the probe tip near the lens assembly 222 for distributing saline solution around the probe tip 220. The inlet port 215 and outlet port 226 can communicate with the lumen 218, which facilitates the delivery of saline flushing from the inlet 215 to the outlet 226. In another example, the saline flushing feature 214 can be a liquid contrast feature or be used as such. In this respect, the liquid contrast agent can be introduced through inlet 215 and emitted through outlet 226 to help enhance the fluorescence fluoroscopic images of the fixation device 14 and surrounding tissues in situ.

[0118] In one example, connector 216 forms the proximal junction of OCT catheter 210. Connector 216 is capable of connecting to an OCT subsystem 230 positioned externally to the patient. OCT subsystem 230 may be a controller for controlling OCT catheter 210 and / or probe 220. For example, OCT subsystem 230 may be configured to generate light and transmit light through OCT catheter 210. In other examples, OCT subsystem 230 may be configured to receive and process light waves returned from probe tip 220. In still other examples, OCT subsystem may be configured to rotate and / or translate probe tip 220 during use. Thus, in some examples, OCT subsystem may include one or more drive motors 232. OCT subsystem 230 may also include or alternatively include one or more imaging engines 234. OCT subsystem 230 may also include or alternatively include one or more computing devices 236. OCT system may also include or alternatively include one or more displays 238. Figure 21A These possible components for the OCT subsystem 230 are depicted. However, it should be understood that the OCT subsystem 230 may include any combination of the depicted components, and such components are merely examples of possible components that may be provided in the OCT subsystem 230. Therefore, additional components not mentioned or shown may be provided in the OCT subsystem 230.

[0119] A drive motor 232 can be connected to an optical fiber 217. The drive motor 232 is configured to rotate and longitudinally translate the optical fiber 217 within a sheath 219. Therefore, the drive motor 232 can be, for example, a single motor with both rotary and linear actuators, or it can be more than one motor, such as a rotary drive motor and a linear drive motor. In any case, the drive motor 232 can provide rotation and pull-back functionality to the OCT catheter 210, which facilitates the acquisition of 360-degree images along a desired length. In other words, the drive motor 232 can be operated such that it continuously rotates the optical fiber 217 within the sheath 219 and selectively translates the optical fiber 217 proximal-to-distal (e.g., pull-back) within the sheath 219 as the optical fiber 217 rotates. Since the probe 212 guides the light radially outward, the captured image is a 360-degree stereoscopic view around the central axis CA of the probe 212. Utilizing the pull-back function, this 360-degree stereoscopic view extends along a pull-back length, for example, 10 mm to 20 mm. In some examples, the pull-back speed can reach 40 mm per second. In other examples, the pull-back speed can be approximately 10 to 20 mm per second. Compared to other current technologies, such as ultrasound, the OCT catheter 210 can capture approximately 180 frames per second to achieve relatively high resolution. While it is preferred that the OCT catheter 210 has both rotation and pull-back capabilities, the OCT catheter 210 may only be configured with rotation functionality, resulting in a 360-degree image in a fixed longitudinal position. In a further embodiment, the OCT catheter 210 may have neither rotation nor pull-back functionality, resulting in a fixed longitudinal position and rotational orientation of the generated image. In such an embodiment, the lens assembly 222 can be configured to have a wider field of view than when both rotation and pull-back functions are included.

[0120] Imaging engine 234 includes other OCT components typically used to facilitate the operation of OCT catheter 210 and to generate image signals from light traveling back from probe tip 220. For example, imaging engine 234 may include an interferometer. The interferometer may have several components, such as a light source (e.g., a laser, laser diode, etc.), a beam splitter, a reflector, and a detector.

[0121] Imaging engine 234 can be coupled to computing device 236, which may include a processor and memory. Computing device 236 is connected to display 238 and converts signals received from imaging engine 234, such as from detectors of imaging engine 234, so that OCT images can be presented to the surgeon on display 238 in real time. Exemplary OCT subsystems that can be used alternatively with OCT catheter 210 are the OPTIS™ Mobile System, OPTIS™ Integrated Next-Generation Imaging System, and OPTIS™ Mobile Next-Generation Imaging System, each with a drive motor and optical controller (DOC), sold by Abbott Vascular of Santa Clara, California, USA. Such systems (e.g., the OPTIS Mobile Next-Generation Imaging System) may include artificial intelligence that can be trained to recognize and highlight (e.g., by applying contours and / or colors) structural components and lobular tissues of fixation device 14 to make them easier for the surgeon to visualize. The computing device 236 can also be connected to one or more other imaging systems, such as an angiography system, to further display on the display 238 the location where OCT images were captured within the anatomical structures of the heart. C. Delivery device

[0122] Now refer to another source Figure 22A The illustration provides a perspective view of an embodiment of a delivery device or delivery catheter 300, which can be used to introduce and position the fixation device 14 as described above. The delivery device 300 can also be configured to receive and position an OCT probe 212 within the fixation device 14, as described in more detail below. In one example, the delivery device 300 includes a shaft 302 having a proximal end 322 and a distal end 324, and a handle 304 attached to the proximal end 322.

[0123] The shaft 302 is shown with a nose 318 near its distal end 324. In this embodiment, the nose 318 has a flange shape. This flange shape prevents the nose 318 from retracting into the guide tube or inlet, as described below. However, it should be understood that the nose 318 can have any shape, including bullet-shaped, round, blunt, or pointed, to name just a few. It should also be understood that in other embodiments, the shaft 302 may not have a nose 318, such that the shaft 302 can retract into and pass through the guide tube. The nose 318 may have openings corresponding to and communicating with a plurality of lumens 331 to 339 extending longitudinally through the shaft 302. Figure 22BAs shown in the cross-sectional view, shaft 302 may include up to nine lumens 331 to 339. Therefore, although nine lumens are depicted, shaft 302 may include more or fewer than nine lumens. In one example, each lumen 331 to 339 may house a separate control element from handle 304 to nose 318 for controlling various mechanisms of the fixture 14.

[0124] For example, as previously discussed Figures 16 to 19 The aforementioned fixing device 14 may include a locking mechanism 106, which includes a release harness 108. A locking line 92 is connected to the release harness 108 to lock and unlock the locking mechanism 106. The locking line 92 extends from the handle 304 through one or more of the lumens 331 to 338 and exits through the nose 318. Additionally, raising and lowering of the proximal element 16 is performed by manipulating the proximal element line 90, as previously described. The proximal element line 90 may also extend from the handle 304 through one or more of the lumens 331 to 338 and exit through the nose 318, where it is connected to the proximal element 16. Furthermore, actuation of the distal element 18 is performed by manipulating an actuator rod 64, which can be connected to the fixing device 14, for example, to a stud 74. Actuator rod 64 extends from handle 304 through lumen 339 and exits from nose 318, lumen 339 being positioned substantially centrally within shaft 302. In this embodiment, the connecting structure of shaft 12 extends from the distal end 324 of shaft 302 and is configured to connect to connecting member 19 of fixing device 14. Actuator rod 64 extends through shaft 12, as... Figure 22A As shown in the example.

[0125] In addition to the exemplary control elements 64, 90, and 92 described above, in various examples, the shaft 302 of the delivery device 300 may also accommodate one or more OCT probes 212. For example, the OCT probes 212 may extend from the handle 304 through any of the lumens 331 to 338, such that the probe tip 220 extends from the nose 318 adjacent to the shaft 12 and the actuator rod 64, as... Figure 22A As shown in the image. Further description follows, in addition to... Figure 22A Various arrangements beyond the OCT probe 212 shown are included. These include up to nine lumens allowing the OCT probe 212 to pass through any of the lumens 331 to 338, such that the probe tip 220 is positioned relative to the fixture 14 in a desired location, while also allowing control elements to be positioned as needed. Furthermore, as previously mentioned, providing saline flushing near the lens assembly 222 may be beneficial to aid image capture. Figure 22AAs shown, a flushing inlet port 317 may be provided in the handle 304. This inlet port 317 may communicate with one or more lumens 331 to 338, allowing the saline flush to be sprayed toward the fixture 14 connected to the shaft 302 and out of the nose 318.

[0126] Handle 304 is attached to the proximal end 322 of shaft 302. Handle 3010 is used to manipulate the coupled fixation device 14 and optionally disengage the fixation device 14 for permanent implantation. In this regard, an example of handle 304 typically includes actuator rod controller 314, actuator rod handle 316, locking line handle 310, and proximal element line handle 312. As described, fixation device 14 is primarily manipulated by actuator rod 64, proximal element line 90, and locking line 92. In one example, actuator rod 64 manipulates distal element 18, proximal element line 90 manipulates proximal element 16, and locking line 92 manipulates locking mechanism 106. According to one example, actuator rod 64 can translate (extend or retract) to manipulate distal element 18 from handle 304. This is achieved, for example, by using actuator rod controller 314. Actuator rod 64 can also rotate to engage or disengage the threaded stud 74 of fixation device 14. This is achieved using actuator lever handle 316. Furthermore, the proximal element line 90 can be extended, retracted, tensioned to various amounts, or removed using the proximal element line handle 312. The locking line 92 can be extended, retracted, tensioned to various amounts, or removed using the locking line handle 310. According to one example, the actuator lever handle 316, actuator lever controller 314, proximal element line handle 312, and locking line handle 310 are all engaged with a body 308, within which the actuator lever 64, proximal element line 90, and locking line 92 are guided into the shaft 302. The example handle 304 also includes a support base 306 connected to the body 308. In one example, the body 308 is capable of sliding along the support base 306 to provide translation of the shaft 302. Furthermore, in one example, the body 308 is capable of rotating about the support base 306 to rotate the shaft 302. Although only one locking line handle 310 and one proximal element handle 312 are shown, it should be understood that more than one handle may be provided for each handle 310, 312.

[0127] According to one example, the handle 304 may also include an OCT probe engagement 315, which provides an opening allowing an OCT probe 212 to be inserted through the handle 304 and into corresponding lumens 331 to 338 of the shaft 302. As mentioned, more than one OCT probe 212 can be used with the delivery device 300. Therefore, more than one OCT probe engagement 315 can be provided. Although not shown, a hemostatic valve can be provided at the OCT probe engagement 315 to prevent backflow and reduce the possibility of air introduction when the OCT probe 315 is inserted into the handle 304. D. Guiding tube assembly

[0128] Now refer to another source Figure 23 This illustration depicts an embodiment of the multi-catheter guidance system or guiding catheter assembly 400 of the present disclosure. System 400 includes an external guiding catheter 410 having a proximal end 414, a distal end 416, and a central lumen 418 passing through the proximal end 414 and the distal end 416. System 400 also includes an internal guiding catheter 420 having a proximal end 424, a distal end 426, and a central lumen 428 passing through the proximal end 424 and the distal end 426. As shown, the internal guiding catheter 420 is coaxially positioned within the central lumen 418 of the external guiding catheter 400. The distal ends 416 and 426 of the catheters 410 and 420 are sized to pass through body cavities, typically through body lumens such as blood vessels. Therefore, in various examples, the distal end 416 preferably has an outer diameter in the range of approximately 0.040 inches to 0.500 inches (1.02 mm to 12.7 mm), more preferably in the range of 0.130 inches to 0.320 inches (3.30 mm to 8.13 mm). In various examples, the central lumen 418 is sized to allow the inner guide tube 420 to pass through; the distal end 426 preferably has an outer diameter in the range of approximately 0.035 inches to 0.280 inches (0.89 mm to 7.11 mm), more preferably in the range of 0.120 inches to 0.200 inches (3.05 mm to 5.08 mm). The central lumen 428 is sized to allow various devices, such as the shaft 20 of the delivery device 300 in one example, to pass through. Therefore, the central lumen 428 preferably has an inner diameter in the range of about 0.026 inches to 0.450 inches (0.66 mm to 11.43 mm), more preferably in the range of 0.100 inches to 0.180 inches (2.54 mm to 4.57 mm).

[0129] According to various examples, the outer guide tube 410 and / or the inner guide tube 420 are pre-bent and / or have a steering mechanism to position the distal ends 416, 426 in a desired direction. The pre-bending or steering of the outer guide tube 410 guides the distal end 416 in a first direction to generate a primary curve, while the pre-bending and / or steering of the inner guide tube 420 guides the distal end 426 in a second direction different from the first direction to generate a secondary curve. In one example, the primary curve and the secondary curve together form a composite curve. As shown, the shaft 302 of the delivery device 300 can be advanced through and guided by the guide tubes 410, 420. The delivery device shaft 302 is advanced through the coaxial guide tubes 410, 420, which guides the shaft 302 in the desired direction, typically through the compound curve in a direction that will allow the distal end 324 of the shaft 302 and the fixing device 14 connected to the distal end 324 to reach their target, such as the mitral or tricuspid valve.

[0130] The steering of the outer guide tube 410 and the inner guide tube 420 can be achieved by actuating one or more steering mechanisms. In some examples, the steering mechanism is actuated using actuators that are typically located on a handle connected to each of the tubes 410 and 420. Figure 23 As illustrated, handle 456 is connected to the proximal end 414 of the external guide tube 410 and remains outside the patient's body during use. Handle 456 includes a steering actuator 450, which can be used to bend, arc, or reshape the external guide tube 410, for example, to form a primary curve. As shown, handle 457 is connected to the proximal end (not shown) of the internal guide tube 420 and can optionally be connected to handle 456 to form a larger handle. Handle 457 includes a steering actuator 452, which can be used to bend, arc, or reshape the internal guide tube 420, for example, to form a secondary curve, and to move the distal end 426 of the internal guide tube 420 through a desired angle.

[0131] Additionally, in some examples, locking actuators 458 and 460 may be used to actuate the locking mechanism to lock conduits 410 and 420 in a specific position. Actuators 450, 452, 458, and 460 are illustrated as buttons; however, it will be understood that these and any additional actuators located on handles 456 and 457 may have any suitable form, including knobs, wheel, lever, switch, latch, sensor, or other device.

[0132] Additionally, in some examples, handle 456 may include a digital or graphical display 461 for information such as data indicating the position of conduits 410, 420 or the force on the actuator. It is also understood that actuators 450, 452, 458, 460 and any other buttons or screens may be located on a single handle connected to both conduits 410, 420.

[0133] Figure 23 The diagram also illustrates that, in some examples, the shaft 302 of the delivery device 300 can extend through handles 456 and 457 and be located within the inner guide tube 420. According to examples of this disclosure, the shaft 302 can extend distally from the distal end 426 of the inner guide tube 416 and the distal end 428 of the outer guide tube 426, allowing the fixation device 14 connected to the distal end 324 of the shaft 302 and the OCT probe 220 extending from the shaft 302 to be positioned within the target valve. As mentioned above, in one example, the shaft 302 may include a flanged nose portion 318 forming a stop. This stop prevents the distal end 324 of the shaft 302 from entering the central lumen 428 of the inner guide tube 420. Therefore, the shaft 302 can advance and retract until the nose portion 318 contacts the distal end 426 of the inner guide tube 420, thus preventing further retraction. This can provide certain advantages during some procedures. It is understood that in embodiments including this stop 318, the shaft 302 will be preloaded within the inner guiding catheter 420 for advancement through the outer guiding catheter 410, or both the shaft 302 and the inner guiding catheter 420 will be preloaded into the outer guiding catheter 410 for advancement to the target valve. This is because the nose 318 prevents the shaft 318 from advancing through the inner guiding catheter 420. However, in other embodiments where the shaft 302 does not include the nose 318, the distal end 324 can be retracted into the inner guiding catheter 420. This allows the shaft 302 to be withdrawn from the guiding catheter assembly 400 while the assembly 400 remains in place within the patient's vascular system. Therefore, another delivery device 300, or the same delivery device 300 having another fixation device 14 connected thereto, can be guided to the same target valve for deployment of the additional fixation device 14. F. OCT probe placement

[0134] When used in conjunction with the fixation device 14, the OCT probe 212 can be arranged in any of a variety of different configurations relative to the fixation device 14. Such configurations allow the surgeon to use the OCT catheter system 200 during surgery to observe and / or visualize the fixation device 14 to assess leaflet capture and / or safety. i. Centrally placed

[0135] Now refer to another source Figures 24A to 24FThis depicts an example of an OCT imaging probe 212 arranged centrally relative to a fixation device 14. In one example, the fixation device 14 includes a first clamp 51a (or a first gripper 51a) and a second clamp 51b (or a second gripper 51b), the first clamp 51a including a first proximal element 16a and a first distal element 18a, and the second clamp 51b including a second proximal element 16a and a second distal element 18b. In one example, the first distal element 18a defines a first lateral extent of the fixation device. The second distal element 18b defines a second lateral extent of the fixation device 14. This is in Figure 24C As shown in the diagram. In some examples, the imaging probe 212 extends through the delivery device 300 and extends distally from the shaft 302, such as from the lumen 335, such that the probe tip 220 is positioned within the lateral range of the fixation device 14. More specifically, in some examples, the probe tip 220 is centrally positioned between clamps 51a and 51b adjacent to and substantially parallel to the central body (or central portion) of the fixation device 14. In the depicted embodiment, the fixation device 14 may include a connecting member 19 and a stud 74, such as Figure 24B The best example shown is...

[0136] Figure 24D This is a schematic cross-sectional view taken at 50% leaflet insertion depth, further illustrating this relationship within a Cartesian coordinate system established by a first plane P1 and a second plane P2. The first plane P1 is orthogonal to the second plane P2, and each plane P1, P2 bisects the axis 12, the actuator rod 64, and the connecting member 19. This intersection defines the origin O. The origin O is also generally the center of the fixing device 14 and coincides with the central axis of the axis 12, the actuator rod 64, and the connecting member 19. The first plane P1 also intersects the first clamping member 51a and the second clamping member 51b. On the other hand, the second plane P2 is substantially equidistant from each of the clamping members 51a to 51b.

[0137] In this example of a first central arrangement, the probe tip 220 intersects the second plane P2, positioning the probe tip 220 equidistant from the clamps 51a to 51b. However, since the shaft 12 and connecting member 19 occupy the origin O, the probe tip 220 is positioned offset from the first plane P1. In other words, the probe tip 220 is oriented 90 degrees clockwise relative to the first plane P1 about the origin O. In this example, the lens assembly 222 can be positioned at a height or position corresponding to 50% insertion depth of the clamps 51a to 51b. In this regard, an OCT cross-sectional image can be generated by the OCT catheter system 200 at this height, which will allow the surgeon to assess whether the lobular tissue in any of the clamps 51a to 51b has reached beyond the critical depth. Figure 24FThis cross-sectional image depicts a 50% lobule insertion depth. As illustrated, the proximal elements 16a to 16b and distal elements 18a to 18b of the first clamp 51a and the second clamp 51b are visible in the OCT image. Furthermore, the lobule tissue is visible between the first clamp 51a and the second clamp 51b, indicating that a depth exceeding the 50% lobule insertion depth threshold has been achieved. The light used by the imaging probe 212 to generate the OCT image penetrates the lobule tissue to a sufficient depth to allow measurement of the lobule thickness at this insertion depth. Therefore, the surgeon can assess the quality of the grasped tissue and the depth of lobule insertion to ensure that the lobule has been adequately secured by the clamps 51a to 51b.

[0138] It should be understood that the clamping elements 51a to 51b can be rotated to various positions relative to the central axis of the fixation device, which may affect the height at which the lens assembly 222 should be positioned at 50% of the lobule insertion depth. However, lobule capture typically occurs at a 60-degree orientation, and therefore the position of the lens assembly can be determined based on this 60-degree orientation. Nevertheless, the lens assembly 222 does not need to be fixed at a specific height. As previously described, the imaging probe 212 may have a pull-back function, allowing the lens assembly 222 to travel longitudinally along the length of the axis 12 and the connecting member 19. In this regard, a three-dimensional 360-degree image from within the fixation device 14 can be generated by the OCT catheter system 200, allowing the surgeon to visualize the entire depth of lobule insertion and the structure of the grasped tissue. Additionally, each proximal element 16a to 16b and / or distal element 18a to 18b may include a reflector 62 positioned at 50% of the lobule insertion depth, such as Figure 24C The best illustration is shown below. In some examples, such a reflector 62 can provide a visual reference in the OCT image for comparison with the depth of the leaflet. Thus, according to an example of this disclosure, if the leaflet depth does not exceed 50% of the leaflet insertion depth indicated by the reflector 62, the surgeon can determine to attempt to re-grasp the leaflet. Therefore, at least one advantage of using the OCT system 200 with the fixation device 14 is the surgeon's ability to create direct cues based on the OCT images generated by the system 200 regarding when to re-grasp the leaflet.

[0139] During operation, the OCT probe catheter 210 can be pre-coupled to the delivery device 300 relative to the fixation device 14, or it can be assembled with the delivery device in the operating room before or after the fixation device 14 is introduced into the patient's heart during surgery. Once the imaging probe tip 212 is in the desired arrangement, the optical fiber 217 rotates and / or translates about the central axis CA of the imaging probe 212. Light 226 is emitted radially outward toward the first clamp 51a and the second clamp 51b, as well as the valve leaflet. The reflected light is captured by the probe tip 220 and transmitted proximally through the optical fiber 217 to the OCT subsystem 230, where this light is used to generate a signal that is converted into a real-time image displayed on the monitor 238. If it is determined that the valve leaflet is not within one of the clamps 51a to 51b, in one example, the surgeon may attempt to re-grasp the leaflet until a depth exceeding 50% of the leaflet depth is achieved.

[0140] Now refer to another source Figure 25 This depicts an example of a second imaging probe centrally arranged within the lateral range of the fixture 14. This arrangement is generally the same as the first arrangement described above, except that the probe tip 220 is positioned on the opposite side of the first plane P1 and the shaft 12 / connecting member 19. In other words, in one example, the probe tip 220 is oriented 90 degrees counterclockwise (i.e., 270 degrees clockwise) relative to the first plane P1 about the origin O. Therefore, the probe tip 220 intersects the second plane P2 and deviates from the first plane P1 along the second plane P2.

[0141] Now refer to another source Figure 26 This illustrates an example of a central arrangement of dual imaging probes. In this example arrangement, the first probe tip 220a and the second probe tip 220b each intersect the second plane P2 and are positioned on opposite sides of the axis 12, offset from the first plane P1. Therefore, the first probe 220a is located in the same position as the first central arrangement described above, and the second probe 220b is located in the same position as the second central arrangement described above. Thus, in this example, the first probe tip 220a is oriented 180 degrees relative to the second probe tip 220b. Although the imaging probes 212a to 212b can each be used to generate their own images from their relative perspectives within the fixture 14, such images can be integrated by the computing device 236 and displayed as a single image on the display 238. Furthermore, although a single imaging probe 212 may be sufficient to visualize both lobes, because the axis 12 is positioned at the origin O of the first plane P1 and the second plane P2, the axis 12 may obstruct a segment of the field of view of either probe. The use of probes 212a to 212b can overcome this obstacle, allowing a full 360-degree field of view to be obtained.

[0142] Now refer to another source Figure 27A and Figure 27B This describes another embodiment of a dual-probe central arrangement. In this example arrangement, the first imaging probe 220a and the second imaging probe 220b each intersect a first plane P1 and are positioned offset from a second plane P2. In other words, the tip of the first probe 220a is oriented 90 degrees clockwise relative to P2 about the origin O, the second imaging probe 220b is oriented 90 degrees counterclockwise relative to P2 about the origin O, and the probes 220a to 220b are oriented 180 degrees relative to each other. Therefore, the tip of the first probe 220a is positioned closer to the first clamp 51a than the tip of the second probe 220b, and the tip of the second probe 220b is positioned closer to the second clamp 51b than the tip of the first probe 220a. This example arrangement can facilitate higher resolution because, compared to other arrangements previously described, the corresponding lens assemblies 222 of the first probe 212a and the second probe 212b are generally closer to their respective clamps 51a to 51b. However, because the probe tips 220a to 220b are positioned directly between the proximal elements 16a to 16b and the shaft 12, the fixation device 14 may not close completely when it is advanced through the guide tube assembly 400. Alternatively, in some examples, after the fixation device 14 is positioned at the target valve and the proximal elements 16a to 16b are moved to a position that provides clearance for the probe tips 220a to 220b, the probes 212a to 212b can be introduced through their respective lumens, such as lumens 337 and 333.

[0143] Now refer to another source Figure 28 and Figure 29 This describes a further example of a dual-probe central arrangement. A first plane P1 and a second plane P2 define four quadrants I to IV around axis 12, such that first quadrant I and second quadrant II are closest to the second clamp 51b, and third and fourth quadrants are closest to the first clamp 51a. In these arrangements, the first probe tip 220a and the second probe tip 220b can extend from their respective lumens of axis 302, such that the first probe tip 220a and the second probe tip 220b are positioned within their respective quadrants.

[0144] For example, such as Figure 28As shown, the first probe tip 220a is located in the third quadrant III, while the second imaging probe 220b is located in the first quadrant I. More specifically, the first probe tip 220a is oriented approximately 45 degrees clockwise relative to P2 about the origin O, while the second probe tip 220b is oriented approximately 45 degrees counterclockwise relative to P1 about the origin O. Therefore, the first probe tip 220a is positioned closer to the first clamp 51a, and the second imaging probe 220b is positioned closer to the second clamp 51b. However, it should be understood that the imaging probes 220a to 220b can occupy any angle between P1 and P2 within their respective quadrants. However, it is preferred that the probe tips 220a to 220b are oriented 180 degrees relative to each other. Except that the first probe tip 220a is positioned in the fourth quadrant IV and the second probe tip 220b is positioned in the second quadrant II, Figure 29 Another example shown is substantially the same as the one just described. Any of these arrangements can be chosen to position the probe tips 220a to 220b closer to the corresponding clamps 51a to 51b, while avoiding interference with the proximal elements 16a to 16b. It is also conceivable that, instead of utilizing a dual-probe configuration, a single probe 212 could be positioned in any of quadrants I to IV if the shaft 12 does not interfere with the probe's ability to capture tissue distal to the probe 212.

[0145] Although in each of the aforementioned dual-probe arrangements, the first probe tip 220a and the second probe tip 220b are depicted at the same height relative to the shaft 12 / connecting member 19, it should be understood that the probe tips 220a to 220b can be positioned at different heights such that the corresponding lens assemblies 222 of the probe tips 220a to 220b can image the clamps 51a to 51b and the valve leaflets at such heights, respectively. For example, the first probe 212a can be positioned such that its lens assembly 222 is positioned at 50% or greater than the leaflet insertion depth (e.g., 50% to 75%), while the second probe tip 220b can be positioned such that its lens assembly 222 is positioned at less than 50% of the leaflet insertion depth (e.g., 25% to 45%). This allows the surgeon to observe multiple leaflet depths without using a pull-back feature. This could be useful in situations where the tortuous path through a vascular system restricts the translational movement of fiber 217.

[0146] Now refer to another source Figure 30A and Figure 30BThe illustration depicts an example fastening device 14', which includes a central body serving as a central spacer 15. In one example, the central spacer 15 is positioned between a first clamping member 51a and a second clamping member 51b. The central spacer 15 may have an oval cross-sectional shape, such as... Figure 30B As shown in the diagram. The central spacer can taper inwards along the longitudinal direction, as... Figure 30A As shown in the diagram. However, the central spacer 15 can have other shapes, such as a teardrop shape. The spacer 15 has a housing or sidewall 15a that defines an internal space 15b. The internal space 15b includes actuator rods 64 for actuating the distal elements 18a to 18b. One or more probe tips 220 may also be disposed within the internal space 15b. For example, as Figure 30B As shown, a single probe tip 220 is positioned adjacent to and generally parallel to the actuator rod 64. Although shown in the same position relative to the actuator rod 64 as the first central arrangement described above, it should be understood that the probe tip 220 can be located in any of the other positions also described above, although within the spacer housing 15a. It should also be understood that a second probe tip can be positioned within the spacer 15 in any of the positions described above with respect to the dual-probe arrangement. The central spacer 15 can be made of a biocompatible polymer material that is translucent to the wavelength of light emitted from the probe tip 220, so that the material will not interfere with the transmission of such light. After the fixation device 14' is attached to the valve tissue, the actuator rod 64 and / or the imaging probe 212 can be removed from the internal space 15b. ii. Example of remote component placement

[0147] Now refer to another source Figures 31A to 31D The diagram depicts an arrangement of dual imaging probe holders relative to a fixing device 14. In this arrangement, the tips 220a and 220b of the first and second imaging probes are positioned within the lateral range of the fixing device 14. However, the probe tips 220a and 220b are positioned within the first and second holders 51a and 51b, respectively, rather than being centrally located. More specifically, the first imaging probe 212a is arranged such that the first probe tip 220a is positioned within the first distal element 18a between the first proximal element 16a and the first distal element 18a, and the second imaging probe 220b is arranged such that the second probe tip 212b is positioned within the second distal element 18b between the second proximal element 16b and the second distal element 18b.

[0148] like Figure 31A and Figure 31DAs best shown, the first imaging probe 221a has a first straight section 221a, a second straight section 221c, and a curved section 221b between the first straight section 221a and the second straight section 221c. The first straight section 221a extends from a lumen of the shaft 302. For example, such a lumen may be lumen 334 or 335. The first straight section 221a extends adjacent to the shaft 12 / connecting member 19 and along the length of the shaft 12 / connecting member 19 toward the distal end 52 of the first distal element 18a. The curved section 221b extends from the distal end of the first straight section 221a and bends toward the engagement surface 50 of the distal element 18a. The second straight section 221c, including a probe tip 220a, extends from the curved section 221b and along the engagement surface 50 in the proximal direction. In this respect, the probe tip 220a is positioned along most of the length of the distal element 18a and parallel to the engagement surface 50. A second straight section 221c is disposed between the mating surface 50 and a crossbar 11 extending across the mating surface 50, the crossbar 11 helping to retain the straight section 221c within the distal element 18a. In other embodiments, the second straight section 221c may replace the cover 100 embedded along the entire length of the distal element 18a (see [link to documentation]). Figure 15A )Inside.

[0149] The crossbar 11 can be positioned at 50% of the leaflet insertion depth of the first clamping member 51a. For example... Figure 31A and Figure 31D As shown, lens assembly 222a can be positioned and secured to the proximal end of crossbar 11. The positioning of lens assembly 222a relative to crossbar 11 at this location allows the surgeon to determine whether a depth exceeding 50% of the leaflet insertion depth has been achieved. Figure 32 In another embodiment shown, the lens assembly 222a can be positioned and fixed to the distal end of the crossbar 11. Figure 33 In another embodiment shown, the first lens assembly 222aa is positioned at the proximal end of the crossbar 11, and the second lens assembly 222ab is positioned at the distal end of the crossbar 11. Alternatively, the first lens assembly 222aa and the second lens assembly 222ab may be disposed on two separate imaging probes disposed in the first distal element 18a.

[0150] Although in some embodiments the lens assembly 222a may be located in a fixed position within the first distal element 18a, other embodiments of the first imaging probe 212a may have a pull-back function. In such embodiments, the optical fiber 217 of the first imaging probe 212a may have a minimum diameter and / or be made of a flexible material to reduce bending stress and facilitate rotational and translational movement of the optical fiber 217 within the sheath 219 to help overcome the small curvature of the curved section 221b. Additionally, the lumen through which the first straight section 221a of the shaft 302 extends may be selected to provide the maximum possible radius of curvature for the first curved section 221b, which further facilitates pull-back. For the first imaging probe 212a, the lumen may be as follows: Figure 31C The lumen 335 shown is positioned along the second plane P2, or the lumen 334 is located in the second quadrant II, offset from P1 and P2. When pull-back is provided, the lens assembly 222a can be translated along most of the length of the first distal element 18a. This allows the surgeon to observe the precise depth at which the lobule is captured. The crossbar 11 can appear as a metallic artifact in the OCT image, indicating a 50% lobule insertion depth threshold to the surgeon and allowing the surgeon to determine that the lobule has been inserted beyond that threshold depth. Alternatively, a reflector, such as reflector 62, can be provided to indicate the critical depth.

[0151] It should be understood that the second imaging probe 212b may be configured identically to the first imaging probe 212a and extend into the second distal element 18b in the same manner as described just with respect to the first imaging probe 212a. Alternatively, the second imaging probe may be configured to be located in a centrally positioned arrangement to provide an alternative visualization perspective. iii. Placement of near-end components

[0152] See also Figure 34A and Figure 34B This describes another example of a dual-probe clamping arrangement. In this arrangement, the tip 220a of the first imaging probe and the tip 220b of the second imaging probe are positioned between the lateral portions of the clamping device 14. However, the probe tips 220a to 220b are respectively disposed on the exterior of the clamping members 51a to 51b and on the proximal elements 16a to 16b, rather than within the clamping members 51a to 51b. More specifically, the first imaging probe 212a is arranged such that the first probe tip 220a is positioned along the proximal side of the first proximal element 16a, and the second imaging probe 220b is arranged such that the second probe tip 212b is positioned along the second proximal element 16b. Similar to the above regarding... Figures 31A to 31DIn the described embodiment, the first imaging probe 212a may have a first straight section 221a, a second straight section 221c, and a curved section 221b extending between the first straight section 221a and the second straight section 221c. The first straight section 221a extends from the delivery device shaft 302 toward the distal end of the fixing device 14. The curved section 221b extends from the distal end of the first straight section 221a toward the first proximal element 16a. The second straight section 221c extends from the curved section 221b and along the proximal side of the first proximal element 16a, and may be fixed to the proximal side of the first proximal element 16a, for example, via an eyelet 65 or a cover covering the element 16a. The first lens assembly 222a may be fixed at 50% of the leaflet insertion depth. However, in other embodiments, a pullback may be provided such that the lens assembly 222a traverses a large portion of the length of the first proximal element 16a. The second imaging probe 212b is similarly constructed and extends along the proximal side of the second proximal element 16b in the same manner as described just with respect to the first imaging probe 212a. Alternatively, the second imaging probe may be constructed in a centrally positioned arrangement or in a distal element placement to provide alternative visualization perspectives. iv. Continuous monitoring and advance reconnaissance

[0153] As shown in the attached figures, or other references... Figure 35 As illustrated, some edge-to-edge repair processes may involve the implantation of more than one fixation device 14. After implanting the first fixation device 14a using OCT imaging, it may be desirable to continuously monitor the first fixation device 14a using the first imaging probe 212a while implanting the second fixation device 14b. Figure 35An implementation of a system facilitating such continuous monitoring is described. In this embodiment, the first imaging probe 212a may extend through the lumen in the guiding conduit assembly 400, rather than through the axis 302 of the delivery device 300. Although the first imaging probe 212a may extend through the lumen in the guiding conduit assembly 400, it can still be positioned relative to the first fixation device 14a in any of the aforementioned relationships. Once the first fixation device 14a is implanted, the delivery device 300 can be withdrawn from the guiding conduit assembly 400 while the first imaging probe 212a remains in place within the fixation device 14a. Another delivery device 300, or an identical delivery device 300 with a second fixation device 14b connected thereto, can be reintroduced to guide the guiding conduit assembly 400 for subsequent implantation. In the sense that repositioning of the guiding conduit assembly 400 may be necessary to place the second fixation device 14b, the first imaging probe 212a may be bent during movement of the assembly 400 to prevent unintentional removal of the probe 212a from the first fixation device 14a. Then, the second imaging probe 212b can be used to assist in the implantation of the second fixation device 14b, and in this case, the second imaging probe 212b can extend through the delivery device 300 as in any of the embodiments described above.

[0154] It is also understood that the first imaging probe 212a can provide preliminary reconnaissance and diagnosis prior to the implantation of the first fixation device 14a. For example, the first imaging probe 212a, or a separate imaging probe, can be advanced from the guiding catheter assembly 400 to the target valve before advancing the first fixation device 14a from the guiding catheter assembly 400. In this regard, the first imaging probe 212a can be advanced to a location between the leaflets (LF) where an OCT scan can be performed. This initial scan can help the surgeon identify an ideal location for implantation and assess leaflet quality before performing the surgery. Anterior or lateral scanning imaging probes can be used for this purpose. G. System Advantages

[0155] The fixation system with leaflet capture assessment described herein offers numerous advantages over currently known techniques and systems. In this regard, as described, using an imaging probe with the fixation device allows surgeons to obtain high-resolution two- and three-dimensional images from within the fixation device and to observe the valve leaflets while they are being grasped. Leaflet thickness can also be measured. The quality of the grasped tissue can also be assessed. Therefore, surgeons can develop direct diagnostic cues around this technique, which simplifies decision-making during surgery.

[0156] Furthermore, the OCT method detailed in this paper is far more accurate than other modalities such as ultrasound. For example, current OCT technology can resolve features / depths at a resolution of 20 μm, which is far superior to conventional intravascular ultrasound (70 μm to 200 μm) in resolving small features. Additionally, OCT devices are much simpler to construct than intravascular ultrasound and can therefore accommodate much smaller probe profiles (e.g., 3 French or less). Moreover, OCT imaging is non-electric within the patient's body because light is passively transmitted through optical fibers, thereby eliminating any need for electrical isolation and any concerns about introducing electrically active components into an electrically active heart. The OCT technology envisioned in this paper could also enhance the performance of tricuspid valve repair and overcome the additional limitations of TEE for this surgical intervention.

[0157] Although the invention described herein has been illustrated with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the invention. Therefore, it should be understood that many modifications can be made to the illustrative embodiments, and other arrangements can be designed, without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A fixation system for engaging a patient's tissue, the fixation system comprising: A delivery device having a shaft defining a lumen extending from a first end of the shaft to a second end; An implantable fixation device having a first clamp, a second clamp, and a central portion connected to and extending between the first and second clamps, the central portion being releasably connected to a distal end of the shaft of a delivery device, the first clamp defining a first lateral extent of the fixation device, and the second clamp defining a second lateral extent of the fixation device; and A first optical coherence tomography (OCT) catheter, configured for cardiovascular imaging, has a first imaging probe including a first end, a second end, and a first lens assembly disposed at the second end of the first imaging probe. The first imaging probe is configured to transmit light between the first end and the second end of the first imaging probe. In the assembled state of the fixing system, the first imaging probe extends through the lumen and out from the second end of the shaft, such that the first lens assembly is positioned between the first lateral range and the second lateral range of the fixing device.

2. The system according to claim 1, wherein, The first imaging probe includes a sheath and an optical fiber disposed within the sheath, and the first lens assembly is disposed at the end of the optical fiber.

3. The system according to claim 2, wherein, The optical fiber is capable of rotating and translating within the sheath.

4. The system according to any one of the preceding claims, wherein, The OCT catheter includes a flushing feature having an inlet port at a first end of the first imaging probe and an outlet port at a second end of the first imaging probe.

5. The system according to any one of the preceding claims, wherein, The first lens assembly includes a lens and a beam deflector configured to deflect light transmitted through the first imaging probe in a radially outward direction from the central axis of the imaging probe.

6. The system according to claim 5, wherein, The beam deflector is configured to deflect the light at a perpendicular angle relative to the central axis.

7. The system according to any one of the preceding claims, wherein, The delivery device includes a handle connected to the first end of the shaft, the handle having an OCT probe engagement configured to receive the first imaging probe and guide the first imaging probe into the lumen of the shaft.

8. The system according to claim 7, wherein, The lumen is a first lumen among a plurality of lumens, and the delivery device further includes an actuator rod extending through a second lumen among the plurality of lumens and extending from a second end of the shaft, at the second end engaging the central portion, the actuator rod being configured to move the first clamping member and the second clamping member from a first position to a second position.

9. The system according to any one of the preceding claims, wherein, The first plane and the second plane each bisect the central portion. The first plane is orthogonal to the second plane and intersects with the first clamping member and the second clamping member. The second plane is positioned equidistant from each of the first clamping member and the second clamping member.

10. The system according to claim 9, wherein, The first lens assembly is positioned adjacent to the central portion such that the first plane intersects with the first lens assembly.

11. The system according to claim 9, wherein, The first lens assembly is positioned adjacent to the central portion such that the second plane intersects with the first lens assembly.

12. The system according to claim 9, wherein, The first plane and the second plane define four quadrants arranged around the central portion, and the first lens assembly is positioned adjacent to the central portion and within one of the four quadrants.

13. The system according to any one of the preceding claims, wherein, The first clamping member includes a first proximal element and a first distal element, and the second clamping member includes a second proximal element and a second distal element.

14. The system according to claim 13, wherein, The first imaging probe extends distally along the central portion and proximally into the space between the first proximal element and the first distal element of the first clamping member, such that the first lens assembly is positioned within the space.

15. The system according to claim 14, wherein, The first distal element includes a crossbar extending across at least a portion of the engagement surface of the first distal element, and the first imaging probe extends between the crossbar and the engagement surface.

16. The system according to claim 15, wherein, The first lens assembly is positioned at one of the proximal end and the distal end of the crossbar.

17. The system according to claim 13, wherein, The first imaging probe extends distally along the central portion and proximally along the proximal side of the proximal element, and the first imaging probe is connected to the first side of the proximal element.

18. The system according to any one of the preceding claims further includes a second OCT conduit having a second imaging probe and a second lens assembly, the second imaging probe extending from the axis of the delivery device such that the second lens assembly is positioned between the first lateral range and the second lateral range.

19. The system according to any one of the preceding claims, wherein, Each of the first clamping member and the second clamping member has a first end portion defining an opening for receiving a leaflet into the clamping member, a second end portion defining a closed end portion of the clamping member, and a length extending between the first end portion and the second end portion defining a maximum leaflet insertion depth.

20. The system according to claim 19, wherein, The lens assembly is positioned relative to the first and second clamps such that light emitted from the lens assembly intersects at 50% of the maximum leaflet insertion depth of the first and second clamps.

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