Valve leaflet resection device and methods

Abstract

A valve leaflet resection device is provided for concurrently cutting through multiple layers of leaflet tissue. The device includes a catheter defining an internal resection space with first and second catheter slots. An actuating member is at least partially located within the internal resection space and is configured for selective longitudinal sliding motion with respect to the first and second catheter slots. A grasping hook is configured for laterally oriented pivotal movement outward from the catheter body through the first catheter slot selectively between hook extended and hook retracted positions. A cutting plane extends parallel to a longitudinal length of the first catheter slot. The device is configured to interpose at least a portion of the unresected valve leaflet laterally between the catheter body and at least a portion of the grasping hook for selective severing. A method of resecting a valve leaflet is also provided.

Description

VALVE LEAFLET RESECTION DEVICE AND METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 649,497, filed May 20, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present technology is related generally to a valve leaflet resection device and related methods.BACKGROUND

[0003] Deployment of a second transcatheter heart valve prosthesis within a previously implanted surgical or transcatheter heart valve prosthesis is referred to as a valve -in- valve procedure. At a native mitral or other heart valve, coronary artery obstruction may occur when leaflets of the first implanted valve (or the native valve) are displaced towards the coronary ostia, sinotubular junction, or another bloodflow structure within the heart during deployment of the second transcatheter valve deployment, thus obstructing coronary blood flow.

[0004] Fig. 1 partially depicts an example heart valve 100 having at least one leaflet 102 (here, an anterior leaflet 102 held within a valve annulus 104). Chordae tendineae 106 attach the leaflet 102 to papillary muscles 108. In order to avoid left ventricular outflow tract obstruction, leaflets 102 of the native heart valve 100 (or a previously implanted artificial heart valve 100) may be resected, severed, or otherwise cut. There may be anatomical advantages to resecting a potentially obstructing leaflet in a triangular resection aperture 110 shape, with the “apex” 112 of the triangular aperture 110 pointing toward the valve annulus 104 and the “base” 114 of the triangular aperture 110 running along the free edge 116 of the leaflet 102.SUMMARY

[0005] The techniques of this disclosure generally relate to a valve leaflet resection device and associated methods for concurrently cutting through multiple layers of leaflet tissue.

[0006] In one aspect, alone or in combination with any other aspect, the present disclosure provides a valve leaflet resection device for concurrently cutting through multiple layersof leaflet tissue. The device includes an elongate guide catheter having proximal and distal catheter ends longitudinally separated by a catheter body. The catheter body defines an internal resection space in fluid communication with an ambient space via elongate first and second catheter slots diametrically spaced across the catheter body. An elongate actuating member has proximal and distal actuating ends longitudinally spaced by an actuating member body. The actuating member is at least partially located within the internal resection space and is configured for selective longitudinal sliding motion with respect to the first and second catheter slots responsive to a longitudinally oriented actuating force being applied to the proximal actuating end. The distal actuating end is configured for laterally oriented pivotal movement with respect to the proximal actuating end and to the internal resection space. An elongate linking arm has proximal and distal linking ends longitudinally spaced by a linking arm body. The proximal linking end is pivotally connected to the catheter body. The distal linking end is configured for laterally oriented pivotal movement with respect to the proximal linking end and to the internal resection space. An elongate grasping hook has proximal and distal hook ends longitudinally spaced by a hook body. The distal hook end is pivotally attached to the actuating member adjacent the distal actuating end. The grasping hook is carried by the actuating member. The distal hook end is configured for laterally oriented pivotal movement, concurrent with pivotal movement of the distal actuating end, with respect to the internal resection space. The proximal hook end is configured for laterally oriented pivotal movement outward from the catheter body through the first catheter slot selectively between hook extended and hook retracted positions. A cutting plane extends parallel to a longitudinal length of the first catheter slot and spans a transverse width of the first catheter slot. A portion of an unresected valve leaflet intersecting the cutting plane is positionable for selective severing. The device is configured to interpose at least a portion of the unresected valve leaflet laterally between the catheter body and at least a portion of the grasping hook when the grasping hook is in the hook extended position. The grasping hook is configured to pull at least a portion of the unresected valve leaflet into the internal resection space, with at least a target line portion of the unresected valve leaflet interposed laterally between the actuating member body and the hook body and at least two layers of the unresected valve leaflet extending through the first catheter slot and intersecting thecuting plane for selective severing, when the grasping hook is in the hook retracted position.

[0007] In another aspect, alone or in combination with any other aspect, the disclosure provides a method of operating a cuting device. The method includes providing the cuting device having an elongate guide catheter having proximal and distal catheter ends longitudinally separated by a catheter body. The catheter body defines an internal resection space in fluid communication with an ambient space via elongate first and second catheter slots diametrically spaced across the catheter body. An elongate actuating member has proximal and distal actuating ends longitudinally spaced by an actuating member body. The actuating member is at least partially located within the internal resection space. An elongate linking arm has proximal and distal linking ends longitudinally spaced by a linking arm body. The proximal linking end is pivotally connected to the catheter body. An elongate grasping hook has proximal and distal hook ends longitudinally spaced by a hook body. The distal hook end is pivotally attached to the actuating member adjacent the distal actuating end. The grasping hook is carried by the actuating member. A cuting plane extends parallel to a longitudinal length of the first catheter slot and spans a transverse width of the first catheter slot. The actuating member is translated in a selective longitudinal sliding motion with respect to the first and second catheter slots responsive to a longitudinally oriented actuating force being applied to the proximal actuating end. The distal actuating end of the actuating member is pivoted in a first laterally oriented pivotal movement toward the second catheter slot responsive to translation of the actuating member in a proximally directed longitudinal sliding motion along a first predetermined translation range. The proximal hook end of the grasping hook is pivoted in laterally oriented pivotal movement outward from the catheter body through the first catheter slot selectively between hook extended and hook retracted positions, responsive to pivoting of the distal actuating end of the actuating member in the first laterally oriented pivotal movement. The distal actuating end of the actuating member is pivoted in a second laterally oriented pivotal movement toward the second catheter slot, responsive to translation of the actuating member in a distally directed longitudinal sliding motion along a second predetermined translation range, at least partially distal to the first predetermined translation range. The proximal hook end of the grasping hook is pivoted in a laterally oriented pivotal movement toward the second catheter slot and the hookretracted position, responsive to pivoting of the distal actuating end of the actuating member in the second laterally oriented pivotal movement.

[0008] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0009] Fig. 1 is a schematic view of a prior art example use environment for a valve leaflet resection device;

[0010] Fig. 2 is a partial perspective front view of a valve leaflet resection device according to an aspect of the present disclosure, in a first condition;

[0011] Fig. 3 is a partial perspective front view of the valve leaflet resection device of Fig. 2, in the first condition and with a portion of an external structure removed;

[0012] Fig. 4 is a partial perspective rear view of the valve leaflet resection device of Fig. 2, in the first condition;

[0013] Fig. 5 is a partial perspective rear view of the valve leaflet resection device of Fig. 2, in the first condition and with a portion of an external structure removed;

[0014] Fig. 6 is an exploded view of the valve leaflet resection device of Fig. 2; and

[0015] Figs. 7A-7F schematically illustrate an example use sequence of the valve leaflet resection device of Fig. 2, optionally in the use environment of Fig. 1.DETAILED DESCRIPTION

[0016] As used herein, the singular forms “a”, “an”, and “the” can include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising”, as used herein, can specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0017] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items.

[0018] As used herein, phrases such as “between X and Y” and “between about X and Y” can be interpreted to include X and Y.

[0019] It will be understood that when an element is referred to as being “on”, “attached” to, “connected” to, “coupled” with, “contacting”, “adjacent”, etc., another element, it can be directly on, attached to, connected to, coupled with, contacting, or adjacent the other element, or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on”, “directly attached” to, “directly connected” to, “directly coupled” with, “directly contacting”, or “directly adjacent” another element, there are no intervening elements present. It will also be appreciated by those of ordinary skill in the art that references to a structure or feature that is disposed “directly adjacent” another feature may have portions that overlap or underlie the adjacent feature, whereas a structure or feature that is disposed “adjacent” another feature might not have portions that overlap or underlie the adjacent feature.

[0020] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper”, “proximal”, “distal”, and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms can encompass different orientations of a device in use or operation, in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features.

[0021] As used herein, the phrase “at least one of X and Y” can be interpreted to include X, Y, or a combination of X and Y. For example, if an element is described as having at least one of X and Y, the element may, at a particular time, include X, Y, or a combination of X and Y, the selection of which could vary from time to time. In contrast, the phrase “at least one of X” can be interpreted to include one or more Xs.

[0022] It will be understood that, although the terms “first”, “second”, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0023] The atached drawings are not shown at scale, and distances therein are not necessarily absolute or relative depictions of locations and interactions of the depicted structures. One of ordinary skill in the art will be able to interpret the drawings and specification of the present application for a particular use environment of the technology(ies) described and shown.

[0024] The “longitudinal” direction, as referenced herein, is substantially parallel to longitudinal arrow “Lo” in the Figures and is substantially vertical, in the orientation of Figs. 2-5.

[0025] The “lateral” direction, as referenced herein, is substantially parallel to the “La” arrow in the Figures and is substantially perpendicular to the longitudinal direction.

[0026] The “transverse” direction, as referenced herein, is substantially parallel to the “T” arrow in the Figures and is substantially perpendicular to both the longitudinal and lateral directions.

[0027] The term “hook” is used herein to indicate a functional pulling action but does not require or imply a curved, looped, and / or barbed structure.

[0028] The invention comprises, consists of, or consists essentially of the following features, in any combination.

[0029] Figs. 2-5 schematically depict a valve leaflet resection device 218 for concurrently cuting through multiple layers of leaflet 102 tissue. The device 218 is shown in Figs. 2-5 in a first, collapsed condition, as will be discussed in more detail below. With reference to Figs. 2-5, the device 218 includes an elongate guide catheter 220 having proximal and distal catheter ends (distal catheter end shown schematically at 222, proximal catheter end located remotely from the portion of the device 218 depicted in Figs. 2-5 and is shown schematically at block “PCA” in Fig. 2.) longitudinally separated by a catheter body 224. The catheter body 224 defines an internal resection space 226 which is in fluid communication with an ambient space 228 (as shown in the Figures, a space outside the device 218) via at least one catheter slot. In the described embodiment, elongate first and second catheter slots 230 and 232, respectively, are substantially spaced apart from one another across the catheter body 224. For use with the mechanism shown and described herein, the operative portions of the first and second catheter slots 230 and 232 will generally be substantially diametrically and laterally spaced apart from one another across the catheter body 224, but one of ordinary skill in the art will be able toreadily provide one or more suitably configured catheter slot(s) 230, 232 for a particular use environment. It should also be understood that, for reasons such as, but not limited to, ease of manufacture, assembly, sterilizing, or any combination thereof, the first and second catheter slots 230 and 232 may be at least partially “connected” to one another, such as along the distal catheter end 222 as shown. The internal resection space 226 may be located at a portion of the catheter body 224 adjacent the distal catheter end 222, and may intersect at least a portion of the distal catheter end 222 directly. It is contemplated that the distal catheter end 222 may be rounded or otherwise configured for nontraumatic insertion into a patient’s vasculature.

[0030] With reference now to the exploded view of Fig. 6, selected components of the device 218 will be described individually. An elongate actuating member 634 has proximal and distal actuating ends 636 and 638, respectively, longitudinally spaced by an actuating member body 640. The actuating member 634 is at least partially located within the internal resection space 226 and is configured for selective longitudinal sliding motion with respect to the first and second catheter slots 230 and 232 responsive to a longitudinally oriented actuating force being applied to the proximal actuating end 636. The distal actuating end 648 is configured for laterally oriented pivotal movement with respect to the proximal actuating end 636 and to the internal resection space 226. The first and second catheter slots 230 and 232 are spaced laterally apart along a diameter of the catheter body 224.

[0031] Also as shown in Fig. 6, an elongate linking arm 642 has proximal and distal linking ends 644 and 646, respectively, longitudinally spaced by a linking arm body 648. The proximal linking end 644 is pivotally connected to the catheter body 224, such as by being pinned or hinged to an internal surface of the internal resection space 226. The distal linking end 646 is configured for laterally oriented pivotal movement with respect to the proximal linking end 644 and to the internal resection space 226.

[0032] An elongate grasping hook, shown at 650 in Fig. 6, has proximal and distal hook ends 652 and 654, respectively, longitudinally spaced by a hook body 656. The distal hook end 654 is pivotally attached to the actuating member 634 (e.g., via a pinned or hinged connection) adjacent the distal actuating end 638. The grasping hook 650 is carried by the actuating member 634. The distal hook end 654 is configured for laterally oriented pivotal movement, concurrent with pivotal movement of the distal actuating end638, with respect to the internal resection space 226. The proximal hook end 652 is configured for laterally oriented pivotal movement outward from the catheter body 224 through the first catheter slot 230 selectively between hook extended and hook retracted positions, as will be discussed further with reference to Figs. 7A-7F.

[0033] As shown in the Figures and described herein, the guide catheter 220, the actuating member 634, the linking arm 642, and the grasping hook 650 may collectively form a four-bar mechanism, which could be considered to be a planar four-bar mechanism having sliding features. For example, in the example embodiment of the Figures, the guide catheter 220, the actuating member 634, the linking arm 642, and the grasping hook 650 may be all constrained to move within a longitudinally and laterally extending mechanism plane, which is substantially parallel to the plane of the page in Figs. 7A-7F. It is also contemplated that the components of the device 218 can be configured to provide predetermined mechanical advantages; transfer, absorption, application, or other interaction(s) of force; and / or to take into account spatial considerations. However, one of ordinary skill in the art can readily provide any desired component(s) and / or operational mechanism(s) for a device 218 to function as described in a particular use environment.

[0034] In order to facilitate desired action and / or motion of the four-bar mechanism, various components of the device 218 may include structural features for helping to direct, constrain, and / or facilitate motion of themselves or other components as desired. For example, and as shown in the Figures, the linking arm 642 may include a transversely extending blocking flange 658 for selective engagement with (e.g., contact with) the second catheter slot 232 to restrict pivoting of the distal linking end 646 toward the first catheter slot 230. As a result, the linking arm 642 is constrained from rotating further toward the first catheter slot 230 than desired. Optionally, at least one flange slot 560 can be provided on the catheter body 224, such as intersecting the second catheter slot 230, to assist with physically blocking the linking arm 642 from pivoting motion past a predetermined “stop” position.

[0035] Similarly, an inner surface of the internal resection space 226 may include a rotation block 362 for selective engagement with at least one of the distal hook end 654 and the distal actuating end 638 to restrict pivoting of the at least one of the distal hook end 654 and the distal actuating end 638 toward the first catheter slot 230. Fig. 3 depicts the distal hook end 654 and the distal actuating end 638 “tucked up” against the rotationblock 362, in a first condition in which the components of the four-bar mechanism are in a compact, stowed position (e.g., for storage and / or transportation through a patient’s vasculature). The rotation block 362 may also be useful in maintaining desired spacing of the two “sides” of the catheter body 224 at the distal catheter end 222, to prevent them splaying outward.

[0036] The actuating member 634 may include any desired structure and / or feature for assisting with generating desired operation of the device 218. For example, a cam bevel 362 could be provided adjacent the proximal actuating end 636 and configured to “ride” along a corresponding structure within the internal resection space 226 or elsewhere in the catheter body 224, in order to urge the actuating member 634 in a desired direction responsive to longitudinal motion of the actuating member 634. In some use environments, the actuating member 634 is longitudinally moved under a pushing or pulling force exerted by a proximally located user on a power wire (shown schematically at “PW” in Fig. 3, and extending through at least a portion of the catheter body 224), optionally via a mechanical advantage device— e.g., a gearbox, motor, spring-bias device, or any other force-generating and / or force-transmitting structure. Various directions and amounts of force exerted on the actuating member 634 can be used to produce a desired operation of the valve leaflet resection device 218, and can be configured by one of ordinary skill in the art for a particular use environment of the device 218.

[0037] For example, the distal linking end 646 of the linking arm 642 may contact the hook body 656 of the grasping hook 650 at a fulcrum location 666 spaced longitudinally apart from both the proximal and distal hook ends 652 and 654, as shown in Fig. 7B. The grasping hook 650 is then urged, by contact with the linking arm 642, into a pivoting motion about the fulcrum location 666 between the hook extended and hook retracted positions. This transitioning of the grasping hook 650 may be useful, for example, in engaging a target line (shown schematically at TL in Fig. 1) of a valve leaflet 102 tissue during operation of the device 218. This transitioning may be assisted, for example, by interaction between the distal actuating end 638 and the distal hook end 654, which may be configured for the actuating member 638 to exert force on the grasping hook 650 by contacting and / or being connected to each other.

[0038] A distalmost portion of at least one of the actuating member 634, the linking arm 642, and the grasping hook 650 may be configured to selectively pivot outward from theinternal resection space 226 laterally through the second catheter slot 232, as shown in at least Figs. 7B and 7D-7E and described further below. This selective pivoting motion outward from the internal resection space 226 could be helpful, for example, in accommodating, actuating, and / or reacting to motion of the grasping hook 650 to interact with a selected valve leaflet 102 as desired, may result from the configuration of the four- bar mechanism comprising the device 218, and may be provided by one of ordinary skill in the art for a particular use environment of the device 218.

[0039] The device 218 may be helpful, in some use environments, for resecting at least a portion of a valve leaflet 102 along at least two intersecting lines to create the aforementioned triangular aperture 110. In doing so, a resected leaflet tissue is severed from the unresected valve leaflet 102, as will be discussed further below with reference to Figs. 7A-7F. In order to resect the leaflet 102 tissue, the device 218 defines a cutting plane CP which extends parallel to a longitudinal length of the first catheter slot 230 and spans a transverse width of the first catheter slot 230. The cutting plane CP is shown schematically in at least Fig. 3. A portion of an unresected valve leaflet 102 intersecting the cutting plane CP is positionable for selective severing in any desired manner.

[0040] For example, and as shown in the Figures, the device 218 may include a blade carriage 668 configured for selective longitudinal movement along a cutting line CL laterally adjacent to the first catheter slot 230. The cutting line CL is contained within the cutting plane CP, to concurrently create at least two resection cuts at areas of the unresected valve leaflet 120 which are at least partially spaced from the target line TL portion. The two resection cuts collectively form the triangular aperture 110 by intersecting one another at the apex 112 and being spaced apart from one another by the leaflet free edge 116 at the base 114 of the triangular aperture 110. The at least two resection cuts in a blade carriage 668 configuration are concurrently created via longitudinal motion of a severing blade 670 carried by the blade carriage 668. In this mechanical cutting configuration, an inner surface of the internal resection space 226 may include a carriage slot 672 configured to guide longitudinal movement of the blade carriage 668 along the cutting line CL.

[0041] As another example of a suitable resection scheme which can be used in addition to or instead of the blade carriage 668, the cutting plane CP may include an electrosurgical member (shown schematically at 374 in Fig. 3 as extending longitudinally and locatedlaterally adjacent to the first catheter slot 230, for use in an electrical cutting configuration. When present, the electrosurgical member 374 defines the cutting line CL and / or the cutting plane CP. The electrosurgical member 374 is selectively energized to concurrently create at least two resection cuts at areas of the unresected valve leaflet 102 at least partially spaced from the target line TL portion. These electrically created resection cuts are concurrently generated via application of severing electrical energy spanning at least a portion of a transverse first slot width of the first catheter slot 230.

[0042] A cutting wire (shown schematically at CW in Fig. 3, and extending through at least a portion of the catheter body 224)) can be provided to transmit motive power to the blade carriage 668 and / or electrical power to the electrosurgical member 374. For example, the blade carriage can be longitudinally moved under a pushing or pulling force exerted by a proximally located user on the cutting wire CW, optionally via a mechanical advantage device— e.g., a gearbox, motor, spring-bias device, or any other force -generating and / or force-transmitting structure. As another example, electrical power could be selectively transmitted down the cutting wire CW from a power source outside the patient’s body when an electrosurgical member 374 is present. Various directions and amounts of mechanical and / or electrical force directed to the blade carriage 668 and / or the electrosurgical member 374 via the cutting wire CW can be used to produce a desired operation of the valve leaflet resection device 218, and can be configured by one of ordinary skill in the art for a particular use environment of the device 218. It should be understood that the blade carriage 668, carriage slot(s) 672, severing blade 679, electrosurgical member 374, or other leaflet-resecting component could be located other than as shown in the Figures, and one of ordinary skill in the art will understand that the cutting plane CP and cutting line CL are not rigidly defined by a certain location upon the device 218, but arise instead from a location of the leaflet-resecting component(s). The cutting plane CP and cutting line CL are “imaginary” constructs used for ease of description here and are defined by the leaflet-resecting component(s), rather than limiting a location or configuration of the leaflet-resecting component(s).

[0043] Any other or additional resection scheme may be provided for mechanically, electrically, or otherwise resecting the leaflet 102 tissue as desired. For example, a rotary blade, a pair of scissors-type shearing blades, a plasma cutter, or any other cutting mechanism / device or combination thereof could be readily provided by one of ordinaryskill in the art for a particular use application of the valve leaflet resection device 218. It is also contemplated that multiple resection cuts (sequentially and / or concurrently) could be made in a single resection procedure using a device 218 based upon the present teachings, and one of ordinary skill in the art can readily provide a device 218 configured for a particular use application.

[0044] The device 218 may include an elongate outer sheath (shown schematically at 476 in Fig. 4) having proximal and distal sheath ends 478 and 480, respectively, longitudinally separated by a sheath body 482 defining a sheath lumen 484 configured to selectively accept the guide catheter 220 at least partially therethrough. At least one of the outer sheath 476 and the guide catheter 220 is manipulable to selectively extend a selected portion of the guide catheter 220 distally from the distal sheath end 476. For example, the guide catheter 220 could be contained at least partially within the outer sheath 476 and carried thereby for travel through the patient’s vasculature to the heart valve 100 area, and then the selected portion of the guide catheter 220 can be advanced distally from the distal sheath end 480 to carry out the described resection action. The selected portion of the guide catheter 220, for most use environments, will include the internal resection space 226, the actuating member 634, the linking arm 642, and the grasping hook 650. Stated otherwise, the sheath lumen 484 may be configured to wholly laterally contain the selected portion of the guide catheter 220 therein for travel of the selected portion of the guide catheter 220 through the vasculature of the patient.

[0045] It is contemplated that sheath(s), guidewire(s), steering mechanism(s), atraumatic tip(s), introducer(s), catheter(s), filter(s), and / or any other structures or combinations thereof could be provided by one of ordinary skill in the art for a particular use environment of the valve leaflet resection device 218, in addition to the specific structures described and shown herein, as well as equivalents thereof.

[0046] Functional aspects of the device 218 will now be discussed in detail with reference to Figs. 7A-7F, which schematically depict a method of operating a cutting device 218 such as that shown in Figs. 1-6 and described above. When the cutting device 218 is used to at least partially resect a heart valve leaflet, it can be considered to be a heart valve leaflet device 218 or a valve leaflet resection device 218. A mitral valve is used as an example use environment herein for the sake of discussion, but any suitable heart valve or other patient tissue could be the subject of use of the device 218.

[0047] First, the device 218 is carried to a target resection site, of any desired type. When that resection site is a heart valve 100 having at least one valve leaflet 102, the guide catheter 220 of the device 218 may be placed at least partially through an outer sheath 476 for transport. For example, the selected portion of the guide catheter 220 (i.e., a portion which includes the internal resection space 226, the actuating member 634, the linking arm 642, and the grasping hook 650, and is shown in Figs. 7A-7F) may be wholly laterally contained within the sheath lumen 484 for travel of the selected portion of the guide catheter 220 through a target lumen (e.g., a patient’s vasculature, when a valve leaflet 102 is to be resected). When the target resection site is an unresected valve leaflet 102, at least a distal portion of the device 218 can be inserted, in any suitable manner, into a patient’s body with the first catheter slot 230 located laterally adjacent a target line TL portion of the unresected valve leaflet 102.

[0048] When the device 218 has achieved a desired position adjacent the target resection site, at least one of the outer sheath 476 and the guide catheter 220 may be manipulated to selectively extend the selected portion of the guide catheter 220 distally from the distal sheath end 480. Alternatively, when no outer sheath 476 is provided, the selected portion of the guide catheter 220 may be positioned as desired adjacent the target resection site.

[0049] Regardless of how the device 218 achieves the desired positioning, Fig. 7A schematically depicts at least the selected portion of the guide catheter 220, and the components carried therein, adjacent a target resection site, represented here by the valve leaflet 102 and attached chordae 106. To move from the Fig. 7A arrangement to that of Fig. 7B, the actuating member 634 is translated in a selective longitudinal sliding motion with respect to the first and second catheter slots 230 and 232, responsive to a longitudinally oriented actuating force being applied to the proximal actuating end 636. For example, a power wire could be pulled on at the proximal catheter end to urge the actuating member 634 proximally, in the direction shown by arrow LI in Fig. 7A. That is, the grasping hook 650 can be manipulated into a hook extended position responsive to translation of the actuating member 634 in a proximally directed longitudinal sliding motion.

[0050] Responsive to translation of the actuating member 634 in a proximally directed longitudinal sliding motion (i.e., parallel to arrow LI) along a first predetermined translation range, the distal actuating end 638 of the actuating member 634 pivots in a firstlaterally oriented pivotal movement (i.e., in the direction of pivot arrow Pl in Fig. 7A) toward the second catheter slot 232. Responsive to pivoting of the distal actuating end 638 of the actuating member 634 in the first laterally oriented pivotal movement (i.e., parallel to arrow Pl), the proximal hook end 652 of the grasping hook 650 pivots in laterally oriented pivotal movement outward from the catheter body 224 through the first catheter slot 230, in the direction of pivot arrow P2 in Fig. 7A. As a result, the grasping hook 650 responsively shifts or pivots selectively between the hook extended position of Fig. 7B and the hook retracted position of Figs. 7A and 7C-7F. One of ordinary skill in the art can readily configure a device 218 for desired grasping hook 650 movement for a particular use environment, based upon the teachings of the present disclosure.

[0051] This action of the grasping hook 650 occurs due, at least in part, to the four-bar mechanism structure of the device, and may be aided by interaction of the linking arm 642 and the grasping hook 650 at the fulcrum location 666. More specifically, when the proximal hook end 652 pivots outward from the catheter body 224 through the first catheter slot 230, the hook body 656 of the grasping hook 650 is contacted with the distal linking end 646 at the fulcrum location 666 of the hook body 656, which is spaced longitudinally apart from both the proximal and distal hook ends 652 and 654. As a result, the grasping hook 650 can be selectively pivoted about the fulcrum location 666 responsive to pivoting of the distal actuating end 638 of the actuating member 634.

[0052] Once the grasping hook 650 has achieved the hook extended position of Fig. 7B (or during transition between hook retracted and hook extended positions) in a leaflet 102 resection use environment, the guide catheter 220 can be manipulated to interpose at least a portion of the unresected valve leaflet 102 laterally between the catheter body 224 and at least a portion of the grasping hook 650, when the grasping hook 650 is in the hook extended position. This manipulation may include, for example, longitudinal motion of all or part of the device 218, selective full or partial motion of the grasping hook 650 between the hook retracted and hook extended positions, any other self-provided or externally imposed motion of the device 218 or portions thereof, and / or any other desired physical / spatial control. As shown in progress in Fig. 7B, the grasping hook 650, in the hook extended position, can be moved to a location laterally separated from at least a portion of the first catheter slot 230 by an unresected valve leaflet 102. An underside (i.e.,a surface facing away from the device 218) of the unresected valve leaflet 102 can then be contacted with the grasping hook 650.

[0053] Once the device 218 has achieved the Fig. 7B configuration (with the unresected valve leaflet 102 at least partially positioned laterally between the hook body 656 and the first catheter slot 230), translation of the actuating member 634 in a distally directed longitudinal sliding motion along a second predetermined translation range— at least partially distal to the first predetermined translation range— responsively pivots the distal actuating end 638 of the actuating member 634 in a second laterally oriented pivotal movement toward the second catheter slot 232. The second laterally oriented pivotal movement is schematically represented by pivot arrow P3 in Fig. 7B. Such pivoting of the distal actuating end of the actuating member in the second laterally oriented pivotal movement responsively causes pivoting of the proximal hook end 652 of the grasping hook 650 in a laterally oriented pivotal movement toward the second catheter slot 232. This motion of the proximal hook end 652 toward the hook retracted position is represented schematically by pivot arrow P3 in Fig. 7B.

[0054] When the device 218 is being used to resect a valve leaflet 102, the grasping hook 650 is configured to pull at least a portion of the unresected valve leaflet 102 into the internal resection space 226, with at least a target line TL portion of the unresected valve leaflet 102 interposed laterally between the actuating member body 640 and the grasping hook body 656. At least two layers of the unresected valve leaflet 102 extend through the first catheter slot 230 in this arrangement (shown schematically in Fig. 7C) and intersect the cutting plane CP for selective severing, when the grasping hook 650 is in the hook retracted position. (The cutting plane CP is shown edge-on in the orientation of Figs. 7A- 7F.) It is contemplated that at least a portion of at least one attached chorda tendinea 106 may be likewise pulled into the internal resection space 226, along with at least the target line TL portion of the unresected valve leaflet 102. The target line TL portion schematically represents a line of connection between the valve leaflet 102 and the grasping hook 650, with the apex 112 of the to-be-formed resection aperture 110 being intersected by the target line TL.

[0055] In summary, in the transition of the device 218 from the position of Fig. 7B to the position of 7C, the grasping hook 650 is manipulated from the hook extended position toward the hook retracted position with at least the target line portion of the unresectedvalve leaflet 102 interposed laterally between the actuating member body 640 and the hook body 656.

[0056] Once the device has achieved the hook-retracted position of Fig. 7C, with the unresected valve leaflet 102 drawn partially into the internal resection space 226 and at least two layers of the valve leaflet 102 tissue extending (optionally under a predetermined amount of tractioning force) through the first catheter slot 230, a distalmost portion of at least one of the actuating member 634, the linking arm 642, and the grasping hook 650 is pivoted outward from the internal resection space 226 laterally toward, and optionally through, the second catheter slot 232, in the direction of pivot arrow Pl in Fig. 7C, such as responsive to motion of the actuating member 634 longitudinally distally (along arrow L2 in Fig. 7C). Accordingly, the device 218 then moves into the configuration shown in Fig. 7D, where the at least two portions of the unresected valve leaflet 102 proximate, and on opposite sides of, the target line TL are drawn toward— and optionally at least partially through— the second catheter slot 232, in addition to being drawn across and intersecting the cutting plane CP. This “drawing” of the leaflet 102 tissue away from the valve annulus 104 holding the remaining portion of the valve leaflet 102 may help with steadying and tensioning the tissue for desired severing, as will be described with reference to the transition between Figs. 7D-7E.

[0057] As previously mentioned, the cutting plane CP may include at least one of a blade carriage 668 and an electrosurgical member 374 for concurrently at least partially severing the at least two layers of the unresected valve leaflet 102 which are intersecting the cutting plane CP, when the grasping hook 650 is in the hook retracted position. The at least one of a blade carriage 668 and an electrosurgical member 374 is used to concurrently create at least two resection cuts at areas of the unresected valve leaflet 102 which are at least partially spaced from the target line TL portion, and thus generate a resected leaflet tissue 786.

[0058] This severing, regardless of the manner in which it is carried out, creates or generates the resected leaflet tissue 786 which, in turn, leaves behind a notch or resection aperture 110 in the remaining portions of the valve leaflet 102 which has a desired substantially triangular, or three-sided, shape. The severing occurs concurrently for all of the at least two layers of leaflet 102 tissue which are drawn into the internal resection space 226 by the grasping hook 650. Mechanical severing via a blade carriage 668 isshown in Figs. 7D-7E, by way of example, but one of ordinary skill in the art will be able to provide electrical cutting and / or cauterizing via an electrosurgical member 374, additionally to or instead of the mechanical cutting, for a particular use environment.

[0059] More specifically, in order to resect the leaflet 102 tissue concurrently along the at least two resection cuts, the blade carriage 668 selectively moves longitudinally in a proximal -to-distal direction to resect the valve leaflet 102. This motion may occur, for example, by a cutting wire CW being pulled on at the proximal catheter end to urge the blade carriage 668 proximally, in the direction shown by arrow LI in Fig. 7D. The valve leaflet 102 is maintained in the resection position with the severing blade 670— carried by the blade carriage 668— spanning at least a portion of a transverse first slot width of the first catheter slot 230 to travel across and thus cut or resect the tissue of the valve leaflet 102 and accordingly reach the position of Fig. 7E. (The severing blade 670 is arranged in, and travels along, the cutting plane CP as defined here for ease of description.) More specifically, the blade carriage is selectively longitudinally moved along a cutting line CL laterally adjacent to the first catheter slot 230, the cutting line CL being contained within the cutting plane CP.

[0060] Longitudinal movement of the blade carriage 668 along the cutting line CL may be guided via at least one carriage slot 672 located on an inner surface of the internal resection space 226, in a guillotine-type manner. For example, two carriage slots 672 may be provided on inwardly transversely facing portions of the first catheter slot 230, with at least a portion of the blade carriage 668 being constrained to ride longitudinally within the carriage slot(s) 672, in a rail-type manner. It is contemplated that a rail-type elongated protrusion (not shown) could also or instead be provided on at least one transversely facing portion of the first catheter slot 230 and the blade carriage 668 could have a notch which tracks along the rail-type protrusion. Any other desired guiding and / or constraint scheme(s) for the blade carriage 668 may be provided by one of ordinary skill in the art for a particular use environment. It is also contemplated that the severing blade 670 could travel along, and define, the cutting line CL without an associated blade carriage, when desired.

[0061] It is contemplated that, instead of a mechanical severing blade 670, an electrosurgical member 374 could be provided extending longitudinally (and / or being carried longitudinally by a blade carriage or another structure) and located laterallyadjacent to the first catheter slot 230. When present, the electrosurgical member 670 may be selectively energized to apply severing electrical energy spanning at least a portion of a transverse first slot width of the first catheter slot 230 and accordingly sever the leaflet 102 tissue to create the resected leaflet tissue 786.

[0062] Regardless of how the resection cuts are made, the device 218 then moves from the position of Fig. 7E to the position of 7F via pivoting of the distalmost portion of at least one of the actuating member 634, the linking arm 642, and the grasping hook 650 is pivoted outward from the internal resection space 226 laterally toward the first catheter slot 230, in the direction of pivot arrow P3 in Fig. 7E. As a result, the device 218 reaches the position shown in Fig. 7F, in which the components are substantially returned to their initial position as shown in Fig. 7A, but now with the resected leaflet tissue 786 at least partially maintained within the internal resection space 226, such as via engagement with the grasping hook 650.

[0063] As in several other phases of operation, the blocking flange 658 of the linking arm 642 can interact with the flange slot(s) 560 of the catheter body 224 at the second catheter slot 232 to prevent further pivoting of the linking arm 642 in the direction of pivot arrow P3. The rotation block 362— also as in several other phases of operation— can prevent pivotal movement of the distal actuating end 638, distal linking end 646, and / or distal hook end 654 further in pivot arrow P3 direction, as well.

[0064] Once the resected leaflet tissue 786 (optionally along with a severed portion of at least one chordae 106) is at least partially maintained in the internal resection space 226, the device 218 may be removed from the patient’s body. It is contemplated that the internal resection space 226 could be configured with sufficient internal volume to accept a predetermined amount of resected leaflet tissue 786 therein. It is also contemplated that the guide catheter 220, with the remaining portions of the device— and the resected leaflet tissue 786— carried therein could be re-surrounded by a sheath lumen 484 of any provided outer sheath 476, via advancement of the outer sheath 476 and / or retraction of the catheter body 224. The use of an outer sheath 476 to laterally “jacket” the internal resection space 226 could be especially helpful if some amount of resected leaflet tissue 786 protrudes (intentionally or not) from the internal resection space 226, such as through the first and / or second catheter slots 230 and 232.

[0065] Whether or not an outer sheath is provided 476, it is also contemplated that longitudinal movement of the blade carriage 668 along the cutting line CL can be at least partially generated by longitudinal movement of the guide catheter 220, either as part of the initial severing cut (e.g., when the blade carriage 668 moves from the position of Fig. 7D to that of Fig. 7E), or during retraction of the guide catheter 220 from the patient’s vasculature (e.g., if the cut is not fully completed via motion of the blade carriage 668 alone).

[0066] In summary, a person having ordinary skill in the art will understand that, alone or in combination with any other aspect, the present disclosure provides an example aspect 1 of a valve leaflet resection device for concurrently cutting through multiple layers of leaflet tissue. The device includes an elongate guide catheter having proximal and distal catheter ends longitudinally separated by a catheter body. The catheter body defines an internal resection space in fluid communication with an ambient space via elongate first and second catheter slots diametrically spaced across the catheter body. An elongate actuating member has proximal and distal actuating ends longitudinally spaced by an actuating member body. The actuating member is at least partially located within the internal resection space and is configured for selective longitudinal sliding motion with respect to the first and second catheter slots responsive to a longitudinally oriented actuating force being applied to the proximal actuating end. The distal actuating end is configured for laterally oriented pivotal movement with respect to the proximal actuating end and to the internal resection space. An elongate linking arm has proximal and distal linking ends longitudinally spaced by a linking arm body. The proximal linking end is pivotally connected to the catheter body. The distal linking end is configured for laterally oriented pivotal movement with respect to the proximal linking end and to the internal resection space. An elongate grasping hook has proximal and distal hook ends longitudinally spaced by a hook body. The distal hook end is pivotally attached to the actuating member adjacent the distal actuating end. The grasping hook is carried by the actuating member. The distal hook end is configured for laterally oriented pivotal movement, concurrent with pivotal movement of the distal actuating end, with respect to the internal resection space. The proximal hook end is configured for laterally oriented pivotal movement outward from the catheter body through the first catheter slot selectively between hook extended and hook retracted positions. A cutting plane extendsparallel to a longitudinal length of the first catheter slot and spans a transverse width of the first catheter slot. A portion of an unresected valve leaflet intersecting the cutting plane is positionable for selective severing. The device is configured to interpose at least a portion of the unresected valve leaflet laterally between the catheter body and at least a portion of the grasping hook when the grasping hook is in the hook extended position. The grasping hook is configured to pull at least a portion of the unresected valve leaflet into the internal resection space, with at least a target line portion of the unresected valve leaflet interposed laterally between the actuating member body and the hook body and at least two layers of the unresected valve leaflet extending through the first catheter slot and intersecting the cutting plane for selective severing, when the grasping hook is in the hook retracted position.

[0067] An example aspect 2 includes the valve leaflet resection device of example aspect 1, wherein the guide catheter, the actuating member, the linking arm, and the grasping hook collectively form a four-bar mechanism.

[0068] An example aspect 3 includes the valve leaflet resection device of example aspect 1, wherein the guide catheter, the actuating member, the linking arm, and the grasping hook all are constrained to move within a longitudinally and laterally extending mechanism plane.

[0069] An example aspect 4 includes the valve leaflet resection device of any of the preceding example aspects, wherein the internal resection space is located at a portion of the catheter body adjacent the distal catheter end.

[0070] An example aspect 5 includes the valve leaflet resection device of any of the preceding example aspects, wherein a distalmost portion of at least one of the actuating member, the linking arm, and the grasping hook selectively pivots outward from the internal resection space laterally through the second catheter slot.

[0071] An example aspect 6 includes the valve leaflet resection device of any of the preceding example aspects, wherein the device includes a blade carriage configured for selective longitudinal movement along a cutting line laterally adjacent to the first catheter slot, the cutting line being contained within the cutting plane, to concurrently create at least two resection cuts at areas of the unresected valve leaflet at least partially spaced from the target line portion via longitudinal motion of a severing blade carried by the blade carriage.

[0072] An example aspect 7 includes the valve leaflet resection device of example aspect 6, wherein the blade carriage selectively moves longitudinally in a proximal-to- distal direction to resect the valve leaflet maintained in the resection position with the severing blade spanning at least a portion of a transverse first slot width of the first catheter slot.

[0073] An example aspect 8 includes the valve leaflet resection device of example aspect 6, wherein longitudinal movement of the blade carriage along the cutting line is at least partially generated by longitudinal movement of the guide catheter.

[0074] An example aspect 9 includes the valve leaflet resection device of any of example aspects 6-8, wherein an inner surface of the internal resection space includes a carriage slot configured to guide longitudinal movement of the blade carriage along the cutting line.

[0075] An example aspect 10 includes the valve leaflet resection device of any of example aspects 1-5, wherein the device includes an electrosurgical member extending longitudinally and located laterally adjacent to the first catheter slot, the electrosurgical member being selectively energized to concurrently create at least two resection cuts at areas of the unresected valve leaflet at least partially spaced from the target line portion via application of severing electrical energy spanning at least a portion of a transverse first slot width of the first catheter slot.

[0076] An example aspect 11 includes the valve leaflet resection device of any of example aspects 1-5, wherein the device includes at least one of a blade carriage and an electrosurgical member for concurrently at least partially severing the at least two layers of the unresected valve leaflet intersecting the cutting plane, when the grasping hook is in the hook retracted position, to create a resected leaflet tissue.

[0077] An example aspect 12 includes the valve leaflet resection device of example aspect 11, wherein the resected leaflet tissue is at least partially maintained within the internal resection space via engagement with the grasping hook.

[0078] An example aspect 13 includes the valve leaflet resection device of any of the preceding example aspects, wherein the linking arm includes a transversely extending blocking flange for selective engagement with the second catheter slot to restrict pivoting of the distal linking end toward the first catheter slot.

[0079] An example aspect 14 includes the valve leaflet resection device of any of the preceding example aspects, wherein an inner surface of the internal resection space includes a rotation block for selective engagement with at least one of the distal hook end and the distal actuating end to restrict pivoting of the at least one of the distal hook end and the distal actuating end toward the first catheter slot.

[0080] An example aspect 15 includes the valve leaflet resection device of any of the preceding example aspects, wherein the distal linking end contacts the hook body of the grasping hook at a fulcrum location spaced longitudinally apart from both the proximal and distal hook ends, the grasping hook pivoting about the fulcrum location between the hook extended and hook retracted positions.

[0081] An example aspect 16 includes the valve leaflet resection device of any of the preceding example aspects, including an elongate outer sheath having proximal and distal sheath ends longitudinally separated by a sheath body defining a sheath lumen configured to selectively accept the guide catheter at least partially therethrough, at least one of the outer sheath and the guide catheter being manipulable to selectively extend a selected portion of the guide catheter including the internal resection space, the actuating member, the linking arm, and the grasping hook distally from the distal sheath end, the sheath lumen being configured to wholly laterally contain the selected portion of the guide catheter therein for travel of the selected portion of the guide catheter through a vasculature of a patient.

[0082] An example aspect 17 includes the valve leaflet resection device of any of the preceding example aspects, wherein the grasping hook is configured to pull at least a portion of the unresected valve leaflet and a portion of at least one attached chorda tendinea into the internal resection space, with at least a target line portion of the unresected valve leaflet interposed laterally between the actuating member body and the hook body and at least two layers of the unresected valve leaflet and the at least one attached chorda tendinea extending through the first catheter slot and intersecting the cutting plane for selective severing, when the grasping hook is in the hook retracted position.

[0083] An example aspect 18 includes a method of resecting a valve leaflet, the method comprising:

[0084] providing the device of any of example aspects 1-5;

[0085] inserting at least a distal portion of the device into a patient’s body with the first catheter slot laterally adjacent the target line portion of the unresected valve leaflet;

[0086] manipulating the grasping hook into the hook extended position responsive to translation of the actuating member in a proximally directed longitudinal sliding motion;

[0087] moving the grasping hook, in the hook extended position, to a location laterally separated from at least a portion of the first catheter slot by an unresected valve leaflet;

[0088] contacting an underside of the unresected valve leaflet with the grasping hook;

[0089] manipulating the grasping hook from the hook extended position toward the hook retracted position with at least the target line portion of the unresected valve leaflet interposed laterally between the actuating member body and the hook body;

[0090] with the grasping hook, urging the at least two layers of the unresected valve leaflet into the first catheter slot and into a position intersecting the cutting plane;

[0091] actuating at least one of a blade carriage and an electrosurgical member to concurrently create at least two resection cuts at areas of the unresected valve leaflet at least partially spaced from the target line portion and thus generate a resected leaflet tissue; and

[0092] maintaining the resected leaflet tissue at least partially within the internal resection space.

[0093] An example aspect 19 includes the method of example aspect 18, including removing the device, with the resected leaflet maintained at least partially within the internal resection space, from the patient’s body.

[0094] Additionally, a person having ordinary skill in the art will understand that, alone or in combination with any other aspect, the present disclosure provides another example aspect 20 of a method of operating a cutting device. The method includes providing the cutting device having an elongate guide catheter having proximal and distal catheter ends longitudinally separated by a catheter body. The catheter body defines an internal resection space in fluid communication with an ambient space via elongate first and second catheter slots diametrically spaced across the catheter body. An elongate actuating member has proximal and distal actuating ends longitudinally spaced by an actuating member body. The actuating member is at least partially located within the internal resection space. An elongate linking arm has proximal and distal linking ends longitudinally spaced by a linking arm body. The proximal linking end is pivotallyconnected to the catheter body. An elongate grasping hook has proximal and distal hook ends longitudinally spaced by a hook body. The distal hook end is pivotally attached to the actuating member adjacent the distal actuating end. The grasping hook is carried by the actuating member. A cutting plane extends parallel to a longitudinal length of the first catheter slot and spans a transverse width of the first catheter slot. The actuating member is translated in a selective longitudinal sliding motion with respect to the first and second catheter slots responsive to a longitudinally oriented actuating force being applied to the proximal actuating end. The distal actuating end of the actuating member is pivoted in a first laterally oriented pivotal movement toward the second catheter slot responsive to translation of the actuating member in a proximally directed longitudinal sliding motion along a first predetermined translation range. The proximal hook end of the grasping hook is pivoted in laterally oriented pivotal movement outward from the catheter body through the first catheter slot selectively between hook extended and hook retracted positions, responsive to pivoting of the distal actuating end of the actuating member in the first laterally oriented pivotal movement. The distal actuating end of the actuating member is pivoted in a second laterally oriented pivotal movement toward the second catheter slot, responsive to translation of the actuating member in a distally directed longitudinal sliding motion along a second predetermined translation range, at least partially distal to the first predetermined translation range. The proximal hook end of the grasping hook is pivoted in a laterally oriented pivotal movement toward the second catheter slot and the hook retracted position, responsive to pivoting of the distal actuating end of the actuating member in the second laterally oriented pivotal movement.

[0095] An example aspect 21 includes the method of example aspect 20, including selectively pivoting a distalmost portion of at least one of the actuating member, the linking arm, and the grasping hook outward from the internal resection space laterally toward the second catheter slot.

[0096] An example aspect 22 includes the method of any of example aspects 20-21, including

[0097] providing the device with a blade carriage carrying a severing blade; and

[0098] selectively longitudinally moving the blade carriage along a cutting line laterally adjacent to the first catheter slot, the cutting line being contained within the cutting plane.

[0099] An example aspect 23 includes the method of example aspect 22, including

[0100] selectively moving the blade carriage longitudinally in a proximal-to-distal direction with the severing blade spanning at least a portion of a transverse first slot width of the first catheter slot.

[0101] An example aspect 24 includes the method of example aspect 23, including at least partially generating longitudinal movement of the blade carriage along the cutting line by longitudinal movement of the guide catheter.

[0102] An example aspect 25 includes the method of any of example aspects 21-24, including

[0103] guiding longitudinal movement of the blade carriage along the cutting line via a carriage slot located on an inner surface of the internal resection space.

[0104] An example aspect 26 includes the method of any of example aspects 20-21, including

[0105] providing the device with an electrosurgical member extending longitudinally and located laterally adjacent to the first catheter slot; and

[0106] selectively energizing the electrosurgical member to apply severing electrical energy spanning at least a portion of a transverse first slot width of the first catheter slot.

[0107] An example aspect 27 includes the method of example aspect 20, wherein the step of pivoting the proximal hook end of the grasping hook in laterally oriented pivotal movement outward from the catheter body through the first catheter slot selectively between hook extended and hook retracted positions includes

[0108] contacting the hook body of the grasping hook with the distal linking end at a fulcrum location of the hook body spaced longitudinally apart from both the proximal and distal hook ends; and

[0109] pivoting the grasping hook about the fulcrum location responsive to pivoting of the distal actuating end of the actuating member.

[0110] An example aspect 28 includes the method of any of the preceding example aspects, including

[0111] providing an elongate outer sheath having proximal and distal sheath ends longitudinally separated by a sheath body defining a sheath lumen;

[0112] placing the guide catheter at least partially through the outer sheath; and

[0113] manipulating at least one of the outer sheath and the guide catheter to selectively extend a selected portion of the guide catheter including the internal resection space, theactuating member, the linking arm, and the grasping hook distally from the distal sheath end.

[0114] An example aspect 29 includes the method of example aspect 28, including wholly laterally containing the selected portion of the guide catheter in the sheath lumen for travel of the selected portion of the guide catheter through a target lumen.

[0115] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0116] While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means / options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and / or any suitable material or combinations of materials; however, the chosen material(s) should be biocompatible for many applications. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment. A “predetermined” status may be determined at any time before the structures being manipulated actually reach that status, the “predetermination” being made as late as immediately before the structure achieves the predetermined status.The term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified— a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item. Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations. A device or method incorporating any of these features should be understood to fall under the scope of this disclosure as determined based upon the claims below and any equivalents thereof.

[0117] Other aspects, objects, and advantages can be obtained from a study of the drawings, the disclosure, and the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A valve leaflet resection device for concurrently cutting through multiple layers of leaflet tissue, the device comprising: an elongate guide catheter having proximal and distal catheter ends longitudinally separated by a catheter body, the catheter body defining an internal resection space in fluid communication with an ambient space via elongate first and second catheter slots diametrically spaced across the catheter body; an elongate actuating member having proximal and distal actuating ends longitudinally spaced by an actuating member body, the actuating member being at least partially located within the internal resection space and configured for selective longitudinal sliding motion with respect to the first and second catheter slots responsive to a longitudinally oriented actuating force being applied to the proximal actuating end, and wherein the distal actuating end is configured for laterally oriented pivotal movement with respect to the proximal actuating end and to the internal resection space; an elongate linking arm having proximal and distal linking ends longitudinally spaced by a linking arm body, the proximal linking end being pivotally connected to the catheter body, and the distal linking end being configured for laterally oriented pivotal movement with respect to the proximal linking end and to the internal resection space; an elongate grasping hook having proximal and distal hook ends longitudinally spaced by a hook body, the distal hook end being pivotally attached to the actuating member adjacent the distal actuating end, the grasping hook being carried by the actuating member, the distal hook end being configured for laterally oriented pivotal movement, concurrent with pivotal movement of the distal actuating end, with respect to the internal resection space, and the proximal hook end being configured for laterally oriented pivotal movement outward from the catheter body through the first catheter slot selectively between hook extended and hook retracted positions; and a cutting plane extending parallel to a longitudinal length of the first catheter slot and spanning a transverse width of the first catheter slot, wherein a portion of an unresected valve leaflet intersecting the cutting plane is positionable for selective severing;wherein the device is configured to interpose at least a portion of the unresected valve leaflet laterally between the catheter body and at least a portion of the grasping hook when the grasping hook is in the hook extended position; and wherein the grasping hook is configured to pull at least a portion of the unresected valve leaflet into the internal resection space, with at least a target line portion of the unresected valve leaflet interposed laterally between the actuating member body and the hook body and at least two layers of the unresected valve leaflet extending through the first catheter slot and intersecting the cutting plane for selective severing, when the grasping hook is in the hook retracted position.

2. The valve leaflet resection device of claim 1, wherein the guide catheter, the actuating member, the linking arm, and the grasping hook collectively form a four-bar mechanism.

3. The valve leaflet resection device of any of the preceding claims, wherein the internal resection space is located at a portion of the catheter body adjacent the distal catheter end.

4. The valve leaflet resection device of any of the preceding claims, wherein a distalmost portion of at least one of the actuating member, the linking arm, and the grasping hook selectively pivots outward from the internal resection space laterally through the second catheter slot.

5. The valve leaflet resection device of any of the preceding claims, wherein the device includes a blade carriage configured for selective longitudinal movement along a cutting line laterally adjacent to the first catheter slot, the cutting line being contained within the cutting plane, to concurrently create at least two resection cuts at areas of the unresected valve leaflet at least partially spaced from the target line portion via longitudinal motion of a severing blade carried by the blade carriage.

6. The valve leaflet resection device of claim 5, wherein longitudinal movement of the blade carriage along the cutting line is at least partially generated by longitudinal movement of the guide catheter.

7. The valve leaflet resection device of any of claims 1-4, wherein the device includes an electrosurgical member extending longitudinally and located laterally adjacent to the first catheter slot, the electrosurgical member being selectively energized to concurrently create at least two resection cuts at areas of the unresected valve leaflet at least partially spaced from the target line portion via application of severing electrical energy spanning at least a portion of a transverse first slot width of the first catheter slot.

8. The valve leaflet resection device of any of the preceding claims, including an elongate outer sheath having proximal and distal sheath ends longitudinally separated by a sheath body defining a sheath lumen configured to selectively accept the guide catheter at least partially therethrough, at least one of the outer sheath and the guide catheter being manipulable to selectively extend a selected portion of the guide catheter including the internal resection space, the actuating member, the linking arm, and the grasping hook distally from the distal sheath end, the sheath lumen being configured to wholly laterally contain the selected portion of the guide catheter therein for travel of the selected portion of the guide catheter through a vasculature of a patient.

9. A method of operating a cutting device, the method comprising: providing the cutting device including an elongate guide catheter having proximal and distal catheter ends longitudinally separated by a catheter body, the catheter body defining an internal resection space in fluid communication with an ambient space via elongate first and second catheter slots diametrically spaced across the catheter body, an elongate actuating member having proximal and distal actuating ends longitudinally spaced by an actuating member body, the actuating member being at least partially located within the internal resection space,an elongate linking arm having proximal and distal linking ends longitudinally spaced by a linking arm body, the proximal linking end being pivotally connected to the catheter body, an elongate grasping hook having proximal and distal hook ends longitudinally spaced by a hook body, the distal hook end being pivotally attached to the actuating member adjacent the distal actuating end, the grasping hook being carried by the actuating member, and a cutting plane extending parallel to a longitudinal length of the first catheter slot and spanning a transverse width of the first catheter slot; translating the actuating member in a selective longitudinal sliding motion with respect to the first and second catheter slots responsive to a longitudinally oriented actuating force being applied to the proximal actuating end; pivoting the distal actuating end of the actuating member in a first laterally oriented pivotal movement toward the second catheter slot responsive to translation of the actuating member in a proximally directed longitudinal sliding motion along a first predetermined translation range; pivoting the proximal hook end of the grasping hook in laterally oriented pivotal movement outward from the catheter body through the first catheter slot selectively between hook extended and hook retracted positions, responsive to pivoting of the distal actuating end of the actuating member in the first laterally oriented pivotal movement; pivoting the distal actuating end of the actuating member in a second laterally oriented pivotal movement toward the second catheter slot, responsive to translation of the actuating member in a distally directed longitudinal sliding motion along a second predetermined translation range, at least partially distal to the first predetermined translation range; and pivoting the proximal hook end of the grasping hook in a laterally oriented pivotal movement toward the second catheter slot and the hook retracted position, responsive to pivoting of the distal actuating end of the actuating member in the second laterally oriented pivotal movement.

10. The method of claim 9, including selectively pivoting a distalmost portion of at least one of the actuating member, the linking arm, and the grasping hook outward from the internal resection space laterally toward the second catheter slot.

11. The method of any of claims 9-10, including providing the device with a blade carriage carrying a severing blade; and selectively longitudinally moving the blade carriage along a cutting line laterally adjacent to the first catheter slot, the cutting line being contained within the cutting plane.

12. The method of claim 11, including selectively moving the blade carriage longitudinally in a proximal-to-distal direction with the severing blade spanning at least a portion of a transverse first slot width of the first catheter slot.

13. The method of claim 11, including at least partially generating longitudinal movement of the blade carriage along the cutting line by longitudinal movement of the guide catheter.

14. The method of any of claims 9-10, including providing the device with an electrosurgical member extending longitudinally and located laterally adjacent to the first catheter slot; and selectively energizing the electrosurgical member to apply severing electrical energy spanning at least a portion of a transverse first slot width of the first catheter slot.

15. The method of any of claims 9-14, including providing an elongate outer sheath having proximal and distal sheath ends longitudinally separated by a sheath body defining a sheath lumen; placing the guide catheter at least partially through the outer sheath; and manipulating at least one of the outer sheath and the guide catheter to selectively extend a selected portion of the guide catheter including the internal resection space, the actuating member, the linking arm, and the grasping hook distally from the distal sheath end.

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