Grip devices and methods for use in transcatheter delivery of prosthetic heart valves

Abstract

A grip device includes a first side and a second side that are movably coupled, via a hinge, to allow the grip device to be transitioned between open and closed configurations. The first side includes a first inner surface having first and second grooves that extend from a distal end to a proximal end of the first side. The second side includes a second inner surface having third and fourth grooves that extend from a distal end to a proximal end of the second side. When the grip device is in the closed configuration, the first and third grooves collectively form a first channel sized to receive and engage an outer surface of a first catheter and the second and fourth grooves collectively form a second channel having a diameter smaller than a diameter of the first channel to receive and engage an outer surface of a second catheter.

Description

Docket No.: VDYN-048 / 01WO 336983-2225GRIP DEVICES AND METHODS FOR USE IN TRANSCATHETER DELIVERY OF PROSTHETIC HEART VALVESCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 720,015, filed November 13, 2024, entitled “Grip Devices and Methods for Use in Transcatheter Delivery of Prosthetic Heart Valves,” the disclosure of which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Embodiments described herein relate generally to transcatheter delivery of medical devices and more particularly, to devices, systems, and / or methods for delivering sidedeliverable transcatheter prosthetic heart valves with a grip.

[0003] Prosthetic heart valves can pose challenges for delivery, deployment, and / or retrieval within a heart, particularly for delivery by catheters (“transcatheter”) through the patient’s vasculature rather than through an open surgical approach. Delivery of traditional transcatheter prosthetic valves generally includes compressing the valve in a radial direction and loading the valve into a delivery catheter such that a central axis of the valve (e.g., an axis along which blood flows or otherwise associated with a direction of blood flow through the prosthetic valve) is parallel to a lengthwise or longitudinal axis extending through a lumen of the delivery catheter. In other words, traditional prosthetic valves are loaded into a delivery catheter such that a radial extent of the valve is aligned with and / or fits within a radial extent of a lumen extending through the delivery catheter. The valves are deployed from an end of the delivery catheter and expanded outwardly in a radial direction from the central axis. The vasculature of a patient, however, places limitations on a diameter of the delivery catheter, which in turn, places limits on the radial extent of the lumen extending through the delivery catheter, and thus, limits the expanded size (e.g., diameter) of a prosthetic valve delivered using traditional, radially compressed delivery methods. The competing interest of minimizing delivery catheter size presents challenges to increasing the expanded diameter of radially compressed valves (e.g., trying to compress too much material and structure into too little space). Moreover, the orientation of the traditional valves during deployment can create additional challenges when trying to align the valves with the native valve annulus.

[0004] Some transcatheter prosthetic valves can be configured for side and / or orthogonal delivery, which can allow for an increase in an expanded diameter relative to traditionallyDocket No.: VDYN-048 / 01WO 336983-2225delivered valves. With side delivery, for example, the valve can be placed in a compressed or delivery configuration and loaded into a delivery catheter such that a central axis of the valve is substantially perpendicular and / or orthogonal to the lengthwise or longitudinal axis extending through the lumen of the delivery catheter. More particularly, the valve can be compressed axially (e.g., along the central axis) and laterally (e.g., along a lateral axis that is perpendicular to the central axis), and uncompressed or elongated longitudinally (e.g., along a longitudinal axis of the valve that is perpendicular to each of the central axis and the lateral axis). The compressed valve (e.g., the valve in a delivery configuration) can be loaded into a lumen of the delivery catheter in a side-ways or orthogonal orientation (e.g., an orientation in which the longitudinal axis of the prosthetic valve is parallel or substantially parallel to the lengthwise or longitudinal axis extending through the lumen of the delivery catheter), advanced through the lumen, and deployed from the end of the delivery catheter. Furthermore, in some instances, the side-ways or orthogonal orientation of the deployed side-delivered valve relative to the delivery catheter, in general, results in the valve being deployed in a desired orientation relative to the native valve annulus.

[0005] Transcatheter delivery and deployment of prosthetic valves (using traditional or sidedelivery methods) presents challenges. The prosthetic valve is compressed to fit into the lumen of the delivery catheter and, typically, is pushed along a length of the delivery catheter for delivery into the native annulus. Often, the compressed prosthetic valve pushes against an inner diameter of the lumen as the valve travels towards the native annulus. Friction between the inner diameter of the lumen and the compressed valve can cause resistance to the advancement of the valve, which can extend procedure times and / or otherwise can cause delays in the procedure. Additionally, structural and / or other physical constraints may make it difficult to exert the desired forces on the compressed valve and / or a catheter, pusher, etc. employed to move the compressed valve to advance the valve through the delivery catheter and into the heart.

[0006] Accordingly, a need exists for devices, systems, and / or methods for delivering sidedeliverable transcatheter prosthetic heart valves with a grip.SUMMARY

[0007] In some embodiments, a grip device for facilitating transcatheter delivery of medical devices such as prosthetic heart valves includes a first side, a second side, and a hinge movably coupling the first and second sides to allow the grip device to be transitioned between an openDocket No.: VDYN-048 / 01WO 336983-2225configuration and a closed configuration. The first side includes a first inner surface having a first groove and a second groove that extend along a longitudinal axis from a distal end to a proximal end of the first side. The second side includes a second inner surface having a third groove and a fourth groove that extend along a longitudinal axis from a distal end to a proximal end of the second side. The grip device is configured, in the closed configuration, such that the first groove and the third groove collectively form a first channel sized to receive and engage an outer surface of a first catheter and the second groove and the fourth groove collectively form a second channel having a diameter smaller than a diameter of the first channel to receive and engage an outer surface of a second catheter.

[0008] In some embodiments, a delivery system for transcatheter delivery of medical devices such as prosthetic heart valves includes a delivery catheter, an advancement catheter, a control catheter, and a grip device. The delivery catheter defines a lumen having an inner diameter configured to receive the prosthetic heart valve in a compressed configuration. The advancement catheter defines a lumen and has an outer diameter smaller than an inner diameter of the lumen of the delivery catheter. The control catheter includes a coupling member at a distal end that is configured to releasably couple to the prosthetic heart valve. The control catheter has an outer diameter that is smaller than the inner diameter of the advancement catheter. The grip device has a first side movably coupled to a second side via a hinge to allow the grip device to transition between an open configuration and a closed configuration. The first side has a first inner surface that defines a first groove and a second groove extending from a distal end to a proximal end of the first side and the second side has a second inner surface that defines a third groove and a fourth groove extending from a distal end to a proximal end of the second side. The grip device is configured, in the closed configuration, such that (i) the first groove and the third groove collectively form a first channel sized to receive and engage the advancement catheter, and (ii) the second groove and the fourth groove collectively form a second channel sized to receive and engage the control catheter.

[0009] In some embodiments, a grip device includes a first side and a second side movably coupled to the first side by a hinge. The first and second sides collectively form a first channel and a second channel. In some implementations, method for facilitating transcatheter delivery of a prosthetic heart valve using the grip device includes loading the prosthetic heart valve in a compressed configuration into a lumen of a delivery catheter of a delivery system, the delivery system including a first catheter and a second catheter extending through the first catheter, a distal end portion of the second catheter being distal to the first catheter andDocket No.: VDYN-048 / 01WO 336983-2225releasably coupled to the prosthetic heart valve. The grip device is manipulated such that a proximal portion of the first catheter is disposed in and frictionally engaged by the first channel. The proximal portion of the first catheter is disposed outside of, and proximal to, the delivery catheter. A distal end portion of the first catheter is disposed in the lumen of the delivery device. The method includes exerting a distally directed force on the grip device to advance each of the first catheter, the second catheter, and the prosthetic heart valve through the lumen of the delivery catheter to position the prosthetic heart valve at a distal end portion of the delivery catheter. The grip device is manipulated such that a proximal portion of the second catheter is disposed in and frictionally engaged by the second channel. The proximal portion of the second catheter is disposed outside of and proximal to the first catheter. The method further includes exerting a distally directed force on the grip device to advance the second catheter relative to the first catheter and release the prosthetic heart valve from the distal end portion of the delivery catheter.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 is a schematic illustration showing a front view of a grip device, shown in an open configuration, which can be implemented in a delivery system to facilitate movement of one or more catheters, medical devices, and / or the like, according to an embodiment.

[0011] FIG. 2 is a schematic illustration showing a front view of the grip device of FIG. 1 shown in a closed configuration.

[0012] FIGS. 3 and 4 are schematic illustrations showing a cross-sectional side view of the grip device of FIGS. 1 and 2 engaging a first portion of a delivery system and a second portion of a delivery system, respectively, according to an implementation.

[0013] FIGS. 5 and 6 are schematic illustrations showing the cross-sectional side view of the grip device of FIGS. 1 and 2 engaging the first and second portions of the delivery system, respectively, according to another implementation.

[0014] FIG. 7 illustrates a delivery system for delivering, for example, a side-deliverable prosthetic valve and a grip device configured to facilitate delivery of the prosthetic valve, according to an embodiment.

[0015] FIGS. 8-11 are various detailed views of a grip device that can be implemented in any of the delivery systems described herein.Docket No.: VDYN-048 / 01WO 336983-2225

[0016] FIG. 12 is a flowchart illustrating a method for facilitating transcatheter delivery of a prosthetic heart valve using a grip device, according to an embodiment.DETAILED DESCRIPTION

[0017] Disclosed embodiments are directed to grip devices and methods for use in transcatheter delivery of medical devices such as, for example, a prosthetic heart valve. For example, any of the delivery and / or deployment systems and / or methods described herein can be used and / or implemented for traditionally deliverable valves or orthogonal / side-deliverable valves unless clearly stated otherwise. Prosthetic valves configured for transcatheter delivery such as those described herein can be configured to transition (e.g., via balloon inflation or via one or more self-expanding structures) between a compressed delivery configuration for introduction into the body via a delivery catheter, and an expanded or deployment / deployed configuration for implanting at a desired location in the body. The delivery catheters used in transcatheter delivery procedures can be, for example, a 24-36 French (Fr) delivery catheter that are advanced through the vasculature of a patient and into a chamber of a heart. Transcatheter procedures are known to include cardiac access via the lumen of the femoral artery and / or vein, via the lumen of the brachial artery and / or vein, via the lumen of the carotid artery, via the lumen of the jugular vein, via the intercostal (rib) and / or sub-xiphoid space, and / or the like. Moreover, entry or access into a chamber of the heart can be via the inferior vena cava (IVC), superior vena cava (SVC), and / or via a trans-atrial (e.g., fossa ovalis or lower) approach.

[0018] Traditionally delivered / deliverable valves are configured to be compressed in, for example, a radial direction relative to the central axis or blood flow direction through the valve and inserted into and / or advanced through the delivery catheter such that the central axis of the compressed valve is parallel to a longitudinal or lengthwise axis of the delivery catheter used to deliver the valve. The valves are deployed from the end of the delivery catheter and expanded outwardly in a radial direction from the central cylinder axis. The delivery orientation of the valve generally means that the valve is completely released from the delivery catheter while in the atrium of the heart and reoriented relative to the annulus, which in some instances, can limit a size of the valve. Accordingly, in some implementations, traditional delivery can be used for relatively small diameter valves such as, for example, prosthetic pulmonary and / or aortic valves.Docket No.: VDYN-048 / 01WO 336983-2225

[0019] Orthogonal or side-delivered / deliverable valves are configured to be compressed in at least one of a lateral direction (orthogonal to the blood flow direction through the valve) or an axial direction (parallel to or aligned with the blood flow direction). In some embodiments, any of the valves can be compressed in two directions - the lateral direction and the axial direction - without compressing the valve in a direction along a lengthwise or longitudinal axis of the valve (orthogonal to the blood flow direction through the valve). In some embodiments, for example, a side delivered prosthetic valve can be transitioned to the compressed configuration by folding the prosthetic valve about or along the longitudinal axis (e.g., to laterally compress the prosthetic valve) and compressing the prosthetic valve axially along or in a direction of the central axis. With orthogonal or side-delivery, the compressed valve can be inserted and / or advanced through a delivery catheter such that the central axis of the compressed valve is substantially orthogonal or perpendicular to a longitudinal or lengthwise axis of the delivery catheter. Said another way, in orthogonal or side-delivery, the lengthwise or longitudinal axis of the valve can be substantially parallel to the lengthwise or longitudinal axis of the delivery catheter through which the valve is delivered. Thus, an orthogonally delivered and / or side delivered prosthetic valve is compressed and / or delivered sideways (e.g., at a roughly 90-degree angle) compared to traditional processes of compressing and delivering transcatheter prosthetic valves.

[0020] In some implementations, orthogonal or side delivery can allow a relatively large diameter valve (e.g., suitable for native mitral and / or tricuspid replacement) to be delivered using, for example, a 24-36 French (Fr) delivery catheter (i.e., a catheter with an outer diameter of about 8 millimeters (mm) to about 12 mm). For example, a relatively large side-deliverable prosthetic valve in an expanded configuration can have a height of about 5-60 mm and a diameter (e.g. a width and / or length) of about 20-80 mm, and in a compressed configuration can have a compressed height of about 8-12 mm, a width (e.g., in a lateral direction) of about 8-12 mm, and a length (e.g., in a longitudinal or lengthwise direction) of about 25-80 mm. As described in further detail herein, the grip devices and delivery methods described herein can aid in overcoming friction forces and / or other resistance associated with advancing such prosthetic valves through delivery catheters that are constrained (in terms of diameter and / or circumference) by a patient’s anatomy (e.g., vasculature).

[0021] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the full scope of the claims. Unless defined otherwise, allDocketNo.: VDYN-048 / 01WO 336983-2225technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0022] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. With respect to the use of substantially any plural and / or singular terms herein, those having skill in the art can translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for sake of clarity.

[0023] In general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” etc.). Similarly, the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, integers (or fractions thereof), steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers (or fractions thereof), steps, operations, elements, components, and / or groups thereof. As used in this document, the term “comprising” means “including, but not limited to.”

[0024] As used herein the term “and / or” includes any and all combinations of one or more of the associated listed items. It should be understood that any suitable disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, contemplates the possibilities of including one of the terms, either of the terms, or both / all terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A andB.”

[0025] All ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof unless expressly stated otherwise. Any listed range should be recognized as sufficiently describing and enabling the same range being broken down into at least equal subparts unless expressly stated otherwise. As will be understood by one skilled in the art, a range includes each individual member.

[0026] The embodiments herein, and / or the various features or advantageous details thereof, are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-Docket No.: VDYN-048 / 01WO 336983-2225known components, methods, processing techniques, etc. may be omitted so as to not obscure the embodiments herein. Like numbers refer to like elements throughout.

[0027] The examples and / or embodiments described herein are intended to facilitate an understanding of structures, functions, and / or aspects of the embodiments, ways in which the embodiments may be practiced, and / or to further enable those skilled in the art to practice the embodiments herein. Similarly, methods and / or ways of using the embodiments described herein are provided by way of example only and not limitation. Specific uses described herein are not provided to the exclusion of other uses unless the context expressly states otherwise. For example, while embodiments are described herein as including a delivery system configured to deliver a prosthetic heart valve, it should be understood that the embodiments and / or methods herein can be used to deliver any suitable medical device, including any number of catheters with or without separate medical devices disposed therein or coupled thereto. The prosthetic valves delivered by the embodiments and / or methods described herein can be used to replace any native valve of a human heart including, for example, a mitral valve, a tricuspid valve, an aortic valve, and / or a pulmonary valve. While some prosthetic valves are described herein in the context of replacing a native mitral valve or a native tricuspid valve, it should be understood that such a prosthetic valve can be used to replace any native valve unless expressly stated otherwise or unless one skilled in the art would clearly recognize that one or more components and / or features would otherwise make the prosthetic valve incompatible for such use. Accordingly, specific examples, embodiments, methods, and / or uses described herein should not be construed as limiting the scope of the disclosure and / or concepts herein.

[0028] FIGS. 1 and 2 are front views of a grip device 100 in an open configuration and a closed configuration, respectively. The grip device 100 (also referred to herein as “grip”) can be implemented in a delivery system 102 to facilitate movement of one or more catheters, medical devices, and / or combinations thereof. The grip includes a first side 108 and a second side 110. The first side 108 and the second side 110 are coupled together via a hinge 112, allowing the grip 100 to transition between the open configuration (FIG. 1) and the closed configuration (FIG. 2), as described in further detail herein. The grip 100 in the open configuration can allow the grip 100 to be positioned or disposed about a portion of one or more catheters.

[0029] As shown in FIG. 1, the first side 108 of the grip 100 includes an inner surface 114 (e.g., a first inner surface) having a first groove 116 and a second groove 118. The first and second grooves 116, 118 extend along a length of the grip 100 from a first face 120 (e.g., a distal face, side, or end) to a second face 122 (e.g., a proximal face, side, or end). Similarly,Docket No.: VDYN-048 / 01WO 336983-2225the second side 110 includes an inner surface 124 (e.g., a second inner surface) having a third groove 126 and a fourth groove 128. The third and fourth grooves 126, 128 extend along the length of the grip 100 from the first face 120 to the second face 122. The first and third grooves 116, 126 define a first opening or channel 130 that extends through the grip 100 when in the closed configuration between the first face 120 and the second face 122, and the second and fourth grooves 118, 128 define the second opening or channel 132 that extends through the grip 100 when in the closed configuration between the first face 120 and the second face 122. The grip 100 in the closed configuration, as shown in FIG. 2, allows the channels 130, 132 (collectively formed by the grooves 116, 126 and 118, 128, respectively) to engage a portion of one or more catheters with a desired amount of friction therebetween to transmit forces therebetween, as described in further detail herein.

[0030] The first side 108 of the grip 100 is movably coupled to the second side 110 of the grip 100 via the hinge 112. The hinge 112 can include a bias member configured to bias the grip 100 in the open configuration. As such, a force can be applied (e.g., a compressive force exerted by a hand of a user such as a surgeon) to the first side 108 and the second side 110 to move or transition the grip 100 to the closed configuration, whereas removal or absence of the force allows the grip 100 to expand to the open configuration naturally or with little to no force. The bias member can be any suitable device such as a spring, living hinge, or the like configured to bias the grip 100 in the open configuration.

[0031] FIGS. 3 and 4 are schematic illustrations of a cross-sectional side view of at least a portion of the delivery system 102. The delivery system 102 includes the grip 100, the first catheter 104, the second catheter 106, and a delivery catheter 136. The first catheter 104 and the second catheter 106 are positioned in a telescoping configuration, with the second catheter 106 configured to be positioned within and / or surrounded by the first catheter 104. As such, an outer diameter of the second catheter 106 is sized to fit within an inner diameter of an inner surface of the first catheter 104 defining a lumen thereof and to allow the second catheter 106 to be moved (e.g., advanced or retracted) through the lumen of the first catheter 104. Thus, the first catheter 104 includes an inner diameter that is larger than an outer diameter of the second catheter 106.

[0032] The second catheter 106 is configured to be releasably coupled to a medical device such as, for example, a prosthetic valve 50. For example, the second catheter 106 can be a control catheter or the like that includes a coupling member at a distal end thereof configured to releasably couple to a portion of the prosthetic valve 50. The coupling member can be a yokeDocket No.: VDYN-048 / 01WO 336983-2225or any other suitable coupling member. The prosthetic valve 50 can be traditionally delivered, transcatheter prosthetic heart valve or a side-delivered, transcatheter prosthetic heart valve. The prosthetic valve 50 is configured to transition between a compressed configuration for transcatheter delivery and an expanded configuration for deployment in an annulus of a native heart valve. As shown in FIG. 3, the prosthetic valve 50 in the compressed configuration can be inserted in the first catheter 104. As such, the prosthetic valve 50 can have a size that allows the prosthetic valve 50 in the compressed configuration to be disposed in the lumen of the first catheter 104. Similarly stated, the first catheter 104 can have a size or at least an inner diameter that allows the compressed prosthetic valve 50 to be disposed in and advanced through the first catheter 104.

[0033] The delivery catheter 136 defines a lumen 138 that can receive the first catheter 104 (with or without the second catheter 106 and prosthetic valve 50 positioned therein) such that the first catheter 104 extends along a longitudinal direction of the delivery catheter 136. The delivery catheter 136 and the first catheter 104 are positioned in a telescoping configuration, with the first catheter 104 configured to be positioned within and / or surrounded by the delivery catheter 136. As such, an outer diameter of the first catheter 104 is sized to fit within an inner diameter of a surface of the delivery catheter 136 defining the lumen 138 and to allow the first catheter 104 to be moved (e.g., advanced or retracted) through the lumen 138. Thus, the lumen 138 includes a diameter that is larger than the outer diameters of each of the first and second catheters 104, 106. With the prosthetic valve 50 disposed in the first catheter 104, the first catheter 104 can be, for example, an advancement catheter configured to advance the compressed prosthetic valve 50 through the delivery catheter 136.

[0034] In transcatheter delivery of devices such as, for example, prosthetic heart valves, a diameter of a patient’s vasculature determines or restricts a size (diameter) of the delivery catheter 136, and in turn, a size of the delivery catheter 136 can determine or restrict a size of a device, catheter, and / or the like that can be delivered through the delivery catheter 136. In the context of heart valve replacements, restrictions on the size of a prosthetic heart valve that can be delivered through the delivery catheter 136 may exclude a portion of the patient population that may otherwise benefit from a prosthetic heart valve replacement (e.g., patients in which an annulus of their native heart valve is larger than the prosthetic valves that can be delivered through the delivery catheter 136). As such, it may be desirable to configure the first catheter 104 to include an outer diameter that is similar to or slightly smaller than the inner diameter of the lumen 138 of the delivery catheter 136 (e.g., to maximize a size of the firstDocket No.: VDYN-048 / 01WO 336983-2225catheter 104). Similarly, in some instances, it may be desirable to position in the first catheter 104 a relatively large prosthetic valve 50. Increasing or maximizing a size of a prosthetic valve and / or the first catheter 104 that are delivered through the delivery catheter 136 (having a size restricted by a patient’s vasculature) can result in relatively large forces being used to advance the first catheter 104 through the delivery catheter 136 and / or the prosthetic valve 50 through the first catheter 104. Thus, the grip 100 can be used to facilitate the application of the forces that (i) advance the compressed prosthetic valve 50, via the second catheter 106 (e.g., a control catheter), into the first catheter 104 (e.g., an advancement catheter) and (ii) advance the first catheter 104 through the delivery catheter 136.

[0035] For example, FIG. 3 shows the grip 100 in the closed configuration with the first side 108 of the grip 100 engaged with the second catheter 106 of the delivery system 102. FIG. 4 is a schematic illustration of a cross-sectional side view of the delivery system 102 with the grip 100 in a closed configuration showing the first side 108 of the grip 100 engaged with the first catheter 104 of the delivery system 102. Although not shown in FIGS. 3 and 4, the second side 110 of the grip 100 can also engage the catheters 104, 106 when the grip 100 is in the closed configuration.

[0036] In use, the grip 100 can be used to facilitate the transcatheter delivery of a medical device such as, for example, the prosthetic heart valve 50. The prosthetic heart valve 50 can be a traditional, radially compressed valve or can be a side-delivered valve. With either approach, the grip 100 can be used to selectively engage at least one of the first catheter 104 or the second catheter 106 to facilitate the application of a force operable to advance and / or retract the first catheter 104 or the second catheter 106 (e.g., relative to and / or through the delivery catheter 136). In the embodiment shown in FIGS. 3 and 4, the second catheter 106 can be, for example, a control catheter that includes a connection member at a distal end thereof that is configured to releasably couple to the prosthetic heart valve 50. The first catheter 104 can be, for example, an advancement catheter configured to be moved (e.g., advanced or retracted) within and / or through the lumen 138 of the delivery catheter 136.

[0037] The lumen of the first catheter 104 (e.g., the advancement catheter) can be configured to receive each of the second catheter 106 (e.g., control catheter) and the prosthetic valve 50 to which the connection member is releasably coupled. The prosthetic valve 50 is in a compressed configuration when disposed in the first catheter 104 (e.g., a radially compressed valve or a side / orthogonally compressed valve), as described above. In some embodiments, the prosthetic valve 50 and the delivery system 102 (or at least portions thereof) can be similar to orDocket No.: VDYN-048 / 01WO 336983-2225substantially the same as the prosthetic valves and delivery systems (respectively) described in detail in U.S. Pat. No. 11,166,814, filed March 5, 2021, entitled “Delivery and Retrieval Devices and Methods for Side-Deliverable Transcatheter Prosthetic Valves,” the disclosure of which is incorporated herein by reference in its entirety.

[0038] With the compressed prosthetic valve 50 in the first catheter 104, the grip 100 (in the open configuration of FIG. 2) can be positioned to surround the second catheter 106 such that when the grip 100 is moved, transitioned, closed, etc. to the closed configuration (FIG. 1), the second and fourth grooves 118, 128 surround the second catheter 106. Put differently, the second catheter 106 is positioned within the second and fourth grooves 118, 128. As such, the second catheter 106 extends through the second channel 132 extending through the grip 100 (e.g., towards the first catheter 104). In turn, the inner surfaces 114, 124 of the grip 100 at least partially grasp, pinch, squeeze, and / or otherwise engage an outer surface of the second catheter 106. Similarly stated, at least a portion of the inner surfaces 114, 124 that collectively form the second channel 132 frictionally engage a portion of the second catheter 106. In some instances, this arrangement can allow the grip 100 to control movement of the second catheter 106 along a length of the first catheter 104 (e.g., in a proximal-distal direction (advancement) and in a distal-proximal direction (retraction)). As such, the grip 100 can facilitate movement of the second catheter 106 with respect to, at least, the first catheter 104.

[0039] In some instances, without the use of the grip 100, exerting a desired amount of force to advance the second catheter 106 and the prosthetic valve 50 through the first catheter 104 can present challenges due to, for example, the use of personal protective equipment (i.e., gloves), the relatively small size of the second catheter 106, the amount of force associated with the advancement, etc. In contrast, the arrangement of the grip 100 in the closed configuration with the portion of the second catheter 106 in the second channel 132 can be such that forces exerted on the grip 100 are transmitted to or on the second catheter 106. In some embodiments, the grip 100 provides an ergonomic interface that allows a medical professional to exert the desired amount of force on the second catheter 106 to advance the second catheter 106 and the prosthetic valve 50 through the first catheter 104. Although not shown in FIGS. 1-4, in some embodiments, the first face 120 or distal end portion of the grip 100 can form flair or flange that can limit and / or substantially prevent a user’s hand from slipping in a distal direction relative to the grip 100. As such, a distally directed force exerted on the grip 100 can be used to advance the second catheter 106 through the first catheter 104 to place the prosthetic valve 50 in a desired position within the first catheter 104, as indicated by the arrow AA inDocket No.: VDYN-048 / 01WO 336983-2225FIG. 3. For example, it may be desirable to advance the second catheter 106 through the first catheter 104 to place the prosthetic valve 50 at or near a distal end of the first catheter 104.

[0040] With the second catheter 106 in a desired position relative to the first catheter 104, the grip 100 can be manipulated to disengage the second catheter 106 and selectively engage the first catheter 104 (FIG. 4). For example, a force operable to place the grip 100 in the closed configuration can be removed, allowing the grip 100 to at least partially transition to the open configuration, which in turn, allows the grip 100 to disengage the second catheter 106.

[0041] In some implementations, the coupling of the second catheter 106 to the prosthetic valve 50, the compression of the prosthetic valve 50 to the compressed configuration, the insertion of the compressed prosthetic valve 50 into the first catheter 104, and the advancement of the second catheter 106 / prosthetic valve 50 to a desired position along the first catheter 104 can be performed away from the patient (e.g., “at a bench” or otherwise not at the operating table or not at the patient. The delivery catheter 136 is placed in a patient and advanced to position a distal end portion of the delivery catheter 136 in a desired location (e.g., into a chamber of the heart). As such, the placement of the delivery catheter 136 is performed, for example, at the patient. Once the prosthetic valve 50 is in a desired position in the first catheter 104 (e.g., prepared for delivery), a portion of the delivery system 102 can be brought to the patient and the first catheter 104 can be inserted into the delivery catheter 136. In some instances, the placement of the delivery catheter 136 and the preparation of the prosthetic valve 50 can be done in at least partially parallel, simultaneous, and / or overlapping procedures.

[0042] As shown in FIG. 4, when the first catheter 104 is at least partially inserted into the lumen 138 of the delivery catheter 136, the grip 100 (in the open configuration of FIG. 2) can be positioned to surround the first catheter 104 such that when the grip 100 is moved to the closed configuration, the first and third grooves 116, 126 surround the first catheter 104. Put differently, the first catheter 104 is positioned within the first and third grooves 116, 126 when the grip 100 is in the closed configuration. As such, the first catheter 104 extends through the first channel 130 extending through the grip 100 (e.g., towards the delivery catheter 136). In turn, the inner surfaces 114, 124 of the grip 100 at least partially grasp, pinch, squeeze, and / or otherwise engage an outer surface of the first catheter 104. Similarly stated, at least a portion of the inner surfaces 114, 124 that collectively form the first channel 130 (having a diameter that is larger than a diameter of the second channel 132) frictionally engage a portion of the first catheter 104. The portion of the first catheter 104 can be, for example, a proximal portion of the first catheter 104 that is proximal to or otherwise disposed outside of the delivery catheterDocket No.: VDYN-048 / 01WO 336983-2225136. A force can then be exerted on the grip 100 to transition the grip 100 to the closed configuration such that the first catheter 104 is disposed within and / or extends through the first opening or channel 130, which has a diameter that is larger than the diameter of the second opening or channel 132.

[0043] In some instances, this arrangement can allow the grip 100 to control movement of the first catheter 104 along a length of the lumen 138 of the delivery catheter 136 (e.g., in a proximal-distal direction (advancement) and in a distal-proximal direction (retraction)). For example, the grip 100 can be used, manipulated, and / or controlled to advance the first catheter 104 toward a distal end of the delivery catheter 136, as indicated by the arrow BB in FIG. 4. In some embodiments, the grip 100 provides an ergonomic interface that allows a medical professional to exert the desired amount of force on the first catheter 104 to advance the first catheter 104 through the delivery catheter 136. As such, the grip 100 can facilitate movement of the first catheter 104 with respect to and / or through the delivery catheter 136. Moreover, with the prosthetic valve 50 in a desired position within the first catheter 104, the advancement of the first catheter 104 through the delivery catheter 136 also advances the prosthetic valve 50 through the delivery catheter 136. In some instances, the distally directed force can be exerted on the grip 100 to move the first catheter 104 (e.g., the advancement catheter) until the first catheter 104 is near, at, or distal to a distal end of the delivery catheter 136.

[0044] With the prosthetic valve 50 in a distal position within the first catheter 104 (e.g., the advancement catheter) and with the second catheter 1 06 in a distal position within the delivery catheter 136, the second catheter 106 (e.g., the control catheter) can be manipulated to release the prosthetic valve 50 from each of the first and delivery catheters 104, 136. In some implementations, a user may exert a force on the second catheter 106 without the use of the grip 100 to release the prosthetic valve 50 (e.g., because relatively limited additional movement is used to release the prosthetic valve 50). In other implementation, the user can manipulate the grip 100 to engage the proximal end portion of the second catheter 106 and exert a distally directed force operable to release the prosthetic valve 50. As such, the prosthetic valve 50 can be allowed to transition to an expanded or at least partially expanded configuration. One or more portions of the delivery system 102 can then be manipulated to deploy the prosthetic valve 50 in an annulus of a native heart valve (not shown in FIGS. 1-4).

[0045] Although not shown in FIGS. 1-4, in some embodiments, the grooves 116, 118, 126, and 128 (or any one or combination of the grooves) can include one or more features configured to enhance or facilitate engagement with the first or second catheters 104, 106. For example,Docket No.: VDYN-048 / 01WO 336983-2225in some embodiments, a relatively soft, ductile, and / or flexible material can be used as one or more liners disposed within the grooves 116, 126 and 118, 128 (e.g., on portions of the inner surfaces 114, 124 associated with the grooves). The relatively soft material can be a polymer having a low durometer such as silicone, rubber, thermoplastic, elastomer, plastic, and / or the like. The relatively soft material can, for example, provide friction and enhance the hold between the grip 100 and the first and / or second catheters 104, 106 (e.g., to reduce or limit relative movement therebetween). Moreover, in some embodiments, the relatively soft liner can be configured to provide an option of modulating an amount of force or pressure associated with the channels 130, 132 engaging the first and second catheters 104, 106, respectively. For example, a thickness of the liner(s) can be such that an inner surface formed by the liner(s) has a diameter that is slightly smaller than the first catheter 104 or the second catheter 106. With the liner(s) being made of a relatively soft or ductile material, the liner(s) can be compressed when engaging the first or second catheter 104, 106. As such, increasing or decreasing a compressive force associated with maintaining the grip in the closed configuration, can increase or decrease, respectively, the compression of the liner(s). This arrangement can allow a user to modulate a force associated with engaging the catheters 104, 106 by increasing or decreasing, for example, a compressive force exerted on the grip to maintain the grip in the closed configuration.

[0046] FIGS. 5 and 6 are schematic illustrations of the cross-sectional side view of at least a portion of the delivery system 102, according to another implementation. In this implementation, the delivery system 102 is configured such that the second catheter 106 extends through the first catheter 104’ and is releasably coupled to the prosthetic valve 50 at a distal end portion (e.g., via a connection member such as a yoke or the like). The prosthetic valve 50, however, is in a distal position relative to the first catheter 104’ (e.g., whether the prosthetic valve 50 is in the compressed configuration or the expanded configuration). While the first catheter 104 described above with reference to FIGS. 3 and 4 has an inner diameter that is sufficiently large to receive the compressed prosthetic valve 50, in the implementation shown in FIGS. 5 and 6, the first catheter 104’ can have a smaller diameter that is sufficiently large to receive a portion of the control catheter 106 but that is not sized to receive the prosthetic valve 50 in the compressed configuration.

[0047] In this implementation, the second catheter 106 can be, for example, a control catheter and the first catheter 104’ can be an advancement catheter. As such, the second catheter 106 is a flexible, controllable, and / or steerable catheter configured to be manipulated duringDocket No.: VDYN-048 / 01WO 336983-2225deployment to seat the prosthetic valve in an annulus of a native heart valve (e.g., tricuspid valve). The first catheter 104’ is disposed over at least a portion of the second catheter 106 to provide an increased column strength and / or rigidity that facilitates advancement of the prosthetic valve 50 through the delivery catheter 136. For example, in some instances, the flexibility of the second catheter 106 may lead to undesired flexing, bending, kinking, binding, etc. during delivery of the prosthetic valve 50 through the delivery catheter 136. As such, the first catheter 104’ can be positioned over the second catheter 106 to provide increased column strength, stiffness, rigidity, etc. that limits such undesired flexing, etc. of the second catheter 106. Moreover, while not shown in FIGS. 5 and 6, the delivery system 102 can include a coupler, lock, collet, and / or other securement feature configured to at least temporarily secure the second catheter 106 in a fixed position relative to the first catheter 104’. Thus, a distally directed force can be exerted on the first catheter 104’ to collectively move the first catheter 104’, the second catheter 106, and the prosthetic valve 50 in, though, and / or otherwise relative to the delivery catheter 136.

[0048] As described above, the grip 100 can be used to facilitate a process of using the delivery system 102 to deliver the prosthetic valve 50 to a chamber of the heart. For example, although not shown in FIGS. 5 and 6, the delivery process can include releasably coupling the second catheter 106 (e.g., a connection member, yoke, etc. at the distal end of the second catheter 106 to the prosthetic valve 50). The prosthetic valve 50 can be advanced (e.g., pulled) through a compression device, funnel, etc. to transition the prosthetic valve 50 from the expanded or at least partially expanded configuration to the compressed configuration for delivery via the delivery catheter 136. The compressed prosthetic valve 50 can be loaded into a capsule, loader, transfer device, etc. (not shown in FIGS. 5 and 6), which can be coupled (e.g., directly or indirectly) to a proximal end portion of the delivery catheter 136, allowing the compressed prosthetic valve 50 to be disposed in the proximal end portion of the delivery catheter 136 (e.g., in the lumen 138). With the prosthetic valve 50 in the compressed configuration disposed in the delivery catheter 136, a distally directed force can be exerted on one or more portions of the delivery system 102 to advance the prosthetic valve 50 through the delivery catheter 136 and into a chamber of the heart.

[0049] For example, in this implementation, the grip 100 (in the open configuration of FIG. 2) can be positioned to surround the first catheter 104’ (the advancement catheter) such that when the grip 100 is moved, transitioned, closed, etc. to the closed configuration (FIG. 1) the first and second grooves 116, 126 surround the first catheter 104’. Put differently, the first catheterDocket No.: VDYN-048 / 01WO 336983-2225104’ is positioned within the first opening or channel 130 extending through the grip 100 (e.g., towards the delivery catheter 136). In turn, the inner surfaces 114, 124 of the grip 100 at least partially grasp, pinch, squeeze, and / or otherwise engage an outer surface of the first catheter 104’.

[0050] As described in detail above with reference to the implementation shown in FIGS. 3 and 4, with the grip 100 in the closed configuration, a distally directed force can be exerted on the grip 100 to advance the first catheter 104’ through the lumen of the delivery catheter 136. With the second catheter 106 being temporarily secured to the first catheter 104’, the second catheter 106 and the prosthetic valve 50 are similarly or concurrently advanced through the delivery catheter 136. In this manner, a distally directed force exerted on the grip 100 can be used to advance the first catheter 104’, the second catheter 106, and the prosthetic valve 50 through at least a portion of the delivery catheter 136, as indicated by the arrow CC in FIG. 5. In some embodiments, the arrangement of the delivery system 102 can be such that fully advancing the first catheter 104’ places the prosthetic valve 50 in a known position along the distal end portion of the delivery catheter 136. For example, each of the delivery catheter 136, the first catheter 104’, and the second catheter 106 has a predetermined, fixed, or known length. The length of the first catheter 104’ can be shorter than the length of the delivery catheter 136 such that when the first catheter 104’ is fully advanced relative to the delivery catheter 136, the prosthetic valve 50 is in a predetermined, known, predictable, and / or repeatable position within a distal end portion of the delivery catheter 136.

[0051] With the first catheter 104’ in a fully advanced position, the temporary securement or coupling between the second catheter 106 and first catheter 104’ can be released, allowing relative movement therebetween. The grip 100 can be manipulated to disengage the first catheter 104’ and selectively engage the second catheter 106, as described in detail above. For example, the grip 100 (in the open configuration of FIG. 2) can be positioned to surround the second catheter 106 such that when the grip 100 is moved to the closed configuration (FIG. 1) the second and fourth grooves 118, 128 surround the second catheter 106. Put differently, the second catheter 106 is positioned within the second opening or channel 132 extending through the grip 100 (e.g., towards the delivery catheter 136). In turn, the inner surfaces 114, 124 of the grip 100 at least partially grasp, pinch, squeeze, and / or otherwise engage an outer surface of the second catheter 106. As described in detail above, a distally directed force can be exerted on the grip 100 to advance the second catheter 106 relative to the first catheter 104’. The distal movement of the second catheter 106 moves the prosthetic valve 50 to release the prostheticDocket No.: VDYN-048 / 01WO 336983-2225valve 50 from the delivery catheter 136 and into the chamber of the heart (e.g., an atrium), which can allow at least a portion of the prosthetic valve to expand. With the prosthetic valve 50 released from the delivery catheter 136, the grip 100 can be disengaged from the second catheter 106. One or more portions of the delivery system 102 can then be manipulated to deploy the prosthetic valve 50 (e.g., via the second catheter 106 and any other suitable portion of the delivery system) in the annulus of the native heart valve.

[0052] While example implementations are described above with reference to FIGS. 3-4 and FIGS. 5-6, the grip 100 can be used to facilitate the transcatheter delivery of one or more devices according to any other suitable implementation. Thus, use of the grip 100 to, for example, facilitate a process of advancing one or more catheters, pushers, devices, etc. is not limited to the example implementations described above.

[0053] FIG. 7 illustrates a delivery and / or retrieval system 202 (“delivery system”) for sidedelivery of a prosthetic valve including a grip device 200. The delivery system 202 can facilitate the compression, loading, advancing, delivering, and / or deploying of a prosthetic valve to a desired position relative to a native valve annulus. The delivery system 202 includes a delivery device 240, a control device 242, and the grip device 200. The delivery device 240 includes a first handle 244 and a delivery catheter 236 extending therefrom. The delivery catheter 236 facilitates delivery of the prosthetic valve to a space within the heart such as an atrium. The control device 242 includes a second handle 246, a first catheter 204 (“advancement catheter”), a second catheter 206 (“control catheter”), and a connection member 208. The control device 242 controls and / or engages one or more portions of the prosthetic valve during delivery and / or retrieval.

[0054] In FIG. 7, the control device 242 and the delivery device 240 are shown in a disassembled or decoupled configuration such that the control device 242 is separated from the delivery device 240. In the disassembled configuration, the control device 242 can be prepared for a transcatheter delivery process by, for example, releasably coupling the connection member 208 at a distal end of the control catheter 206 to the prosthetic valve (not shown in FIG. 7). The prosthetic valve can be advanced (e.g., pulled) through a compression device, funnel, etc. to transition the prosthetic valve to a compressed configuration for delivery. In some implementation, the prosthetic valve can be a side deliverable prosthetic valve that can be, for example, compressed along a vertical axis (to reduce a vertical dimension of the valve) and a lateral axis (to reduce a lateral dimension of the valve) to place the valve in a compressed configuration. Alternatively, the prosthetic valve can be a traditionally deliverable valve thatDocket No.: VDYN-048 / 01WO 336983-2225can be, for example, radially compressed to the compressed configuration. The prosthetic valve in the compressed configuration can be loaded into a capsule, loader, transfer device, etc., which can be coupled to a proximal coupler 245 of the first handle 244. The prosthetic valve can then be advanced into the first handle 244 and / or a proximal end portion of the delivery catheter 236 disposed in the first handle 244.

[0055] In some embodiments, the control catheter 206 is a flexible and / or steerable catheter configured to be manipulated during deployment to seat the prosthetic valve in an annulus of a native heart valve (e.g., tricuspid valve). The control catheter 206 or at least a portion thereof can be disposed in the advancement catheter 204, which is configured to provide column strength and / or rigidity to facilitate advancement of the prosthetic valve through the delivery device 240. More specifically, the delivery system can include a collet 205A (or other suitable coupler, lock, feature, etc.) configured to temporarily secure the control catheter in a fixed position relative to the advancement catheter (as shown, for example, in FIG. 7).

[0056] As such, at least a portion of a force exerted on the advancement catheter 204 is transmitted or transferred to the control catheter 206, which in turn pushes the prosthetic valve via the connection member 208. More specifically, in the assembled configuration of the delivery system 202, a distally directed force can be exerted on the advancement catheter 204 to advance the advancement catheter 204, the control catheter 206, and the prosthetic valve toward a distal end of the delivery catheter 236. As such, a portion of the advancement catheter 204, at least a portion of the compressed prosthetic valve, and a portion of the control catheter 206 can be positioned within or surrounded by the delivery catheter 236 in the assembled configuration. In this manner, the distally directed force can be exerted on the advancement catheter 204 to push the prosthetic valve to a position at or near a distal end of the delivery catheter 236. The prosthetic valve can then be released from the delivery catheter 236 and / or advancement catheter 204 to deliver the prosthetic valve to a chamber of the heart. When the prosthetic valve has been delivered to the chamber of the heart (e.g., an atrium), the prosthetic valve can be allowed to expand and the delivery system 202 can be manipulated to deploy the prosthetic valve within an annulus of a native heart valve.

[0057] As described above with reference to the grip 100 shown in FIGS. 1-6, the grip 200 can facilitate movement of the control catheter 206 or the advancement catheter 204 with respect to at least the delivery catheter 236. The grip 200 of FIG. 7 is schematic in nature. As such, the sizing, shape, orientation, etc., of the grip 200 may be different than the illustration of FIG. 7. The grip 200 can have a generally cylindrical body having a first face 220 (e.g., a distal face,Docket No.: VDYN-048 / 01WO 336983-2225surface, end, portion, etc.) opposite a second face 222 (e.g., a proximal face, surface, end, portion, etc.). The grip 200 includes and / or defines a first opening or channel 230 and a second opening or channel 232, each of which extends along a longitudinal axis of the cylindrical body and through each of the first face 220 and the second face 222. The first opening or channel 230 is sized, fitted, and / or configured to receive, wrap, surround, and / or grip the advancement catheter 204 to facilitate movement thereof. For example, the first channel 230 or a portion of an inner surface of the grip 200 defining the first channel 230 engages with an outer surface of the advancement catheter 204 to allow one or more forces to be transmitted therebetween. Specifically, the first channel 230 can engage the outer surface of the advancement catheter 204 such that a distally directed force exerted on the grip 200 moves and / or advances the advancement catheter 204 at least partially through a lumen of the delivery catheter 236, as described in connection with FIG. 5.

[0058] More specifically, with the compressed valve at or near a proximal portion of the delivery catheter 236, the grip 200 can be used to push the advancement catheter 204 to advance the compressed valve (e.g., via the connection member 208 and the control catheter 206) within the delivery catheter 236 to or near a distal end portion of the delivery catheter 236. For example, the grip 200 can be manipulated to position the grip 200 (e.g., in an open configuration) about a portion of the advancement catheter 204 that is proximal to the delivery catheter 236. Once in a desired position, the grip 200 can be closed so that the portion of the advancement catheter 204 is disposed within the first opening or channel 230 of the grip 200. Accordingly, as described in detail above with reference to the grip 100 shown in FIGS. 1-6, a distally directed force can be exerted on the grip 200 to advance the advancement catheter 204 through the lumen of the delivery catheter 206. With advancement catheter 204 being at least temporarily fixed to the control catheter 206, and with the connection member 208 of the control catheter 206 releasably coupled the compressed prosthetic valve, the advancement of the advancement catheter 204 also advances the compressed prosthetic valve to or toward the distal end portion of the delivery catheter 236.

[0059] Once the compressed prosthetic valve is in a desired position (e.g., a distal position) at, near, or past the distal end of the delivery catheter 236, the securement between the control catheter 206 and the advancement catheter 204 can be released, allowing relative movement therebetween. The grip 200 can then be manipulated to position the grip 200 (e.g., in an open configuration) about a portion of the control catheter 206 (e.g., a proximal portion of the control catheter 206 that is proximal to the advancement catheter 204) and transitioned to the closedDocket No.: VDYN-048 / 01WO 336983-2225configuration so that the portion of the control catheter 206 is disposed within the second opening or channel 232 of the grip 200. Accordingly, as described in detail above with reference to the grip 100 shown in FIGS. 1-6, a distally directed force can be exerted on the grip 200 to advance the control catheter 206 relative to the advancement catheter 204 and the delivery catheter 236. The distal movement of the control catheter 206 can release the prosthetic valve from the delivery catheter 236 and into a chamber of the heart (e.g., an atrium), which can allow at least a portion of the prosthetic valve to expand. The delivery system 202 can then be manipulated to deploy the prosthetic valve (e.g., via the control catheter 206 and any other suitable portion of the delivery system) in the annulus of the native heart valve. Accordingly, the grip 200 can be similar, in at least form and / or function to the grip 100.

[0060] While the control device 242 is shown in FIG. 7 with the control catheter 206 extending through the advancement catheter 204 such that the connection member 208 is distal to a distal end of the advancement catheter 204, preparation of the control device 242 for transcatheter delivery of the prosthetic valve may include coupling the connection member 208 to the prosthetic valve, transitioning the prosthetic valve to the compressed configuration (as described above), and then loading the prosthetic valve in the compressed configuration into the lumen of the advancement catheter 204. The prosthetic valve is then advanced, via the control catheter 206, through the advancement catheter 204 such that the prosthetic valve is disposed within the advancement catheter 204 in a position at or near a distal end of the advancement catheter 204. In some implementations, the grip 200 can be manipulated to position a proximal portion of the control catheter 206 in the second channel 232 and used to exert a distally directed force on the control catheter 206 to advance the compressed prosthetic valve and the control catheter 206 through the advancement catheter 204. With the compressed valve in a desired position within the advancement catheter 204, the delivery system 202 can be transitioned to an assembled configuration.

[0061] Once the compressed prosthetic valve is in the desired (e.g., distal position), the delivery system 202 can be transitioned to the assembled configuration. For example, a distal end of the advancement catheter 204 can be inserted through the first handle 244 of the delivery device 240 and at least partially into a proximal portion of the delivery catheter 236. A distal coupler 205B disposed about a portion of the advancement catheter 204 can be coupled to the proximal coupler 245 of the first handle 244, thereby placing the delivery system 202 in the assembled configuration. In some implementations, with the advancement catheter 204 at least partially disposed in a proximal portion of the delivery catheter 236, the grip 200 can be usedDocket No.: VDYN-048 / 01WO 336983-2225to push the advancement catheter 204 to advance the advancement catheter 204 to or near a distal end portion of the delivery catheter 236. For example, the grip 200 can be manipulated to position the grip 200 (e.g., in an open configuration) about a portion of the advancement catheter 204 that is proximal to the coupler 205B. Once in a desired position, the grip 200 can be closed so that the portion of the advancement catheter 204 is disposed within the first opening or channel 230 of the grip 200. For example, the grip 200 engages with an outer surface of the advancement catheter 206 to move and / or advance the advancement catheter 206 at least partially into and / or through the lumen of the delivery catheter 236. Accordingly, as described in detail above with reference to the grip 100 shown and implemented as in FIGS. 3 and 4, a distally directed force can be exerted on the grip 200 to advance the advancement catheter 204 through the lumen of the delivery catheter 236. Once in a desired position at, near, or past the distal end of the delivery catheter 236, the delivery system 202 (e.g., the second handle 246 and / or any other suitable portion of the delivery system 202) can be manipulated to deploy the prosthetic valve in the annulus of the native heart valve. In some implementations, the manipulation of the delivery system 202 can include using the grip 200 to advance the control catheter 206 relative to the advancement catheter 204 and the delivery catheter 236. In other implementations, the prosthetic valve can be released from the delivery catheter 236 and into a chamber of the heart without using the grip 200.

[0062] FIGS. 8-11 are various detailed views of a grip 300 that can be implemented in the delivery system 102 and / or the delivery system 202. FIGS. 8-10 show the grip 300 in a closed configuration. FIG. 11 shows the grip 300 in an open configuration. The grip 300 includes a first side 308, a second side 310, a first face 320 (e.g., a distal face, surface, end, portion, etc.), a second face 322 (e.g., a proximal face, surface, end, portion, etc.), a hinge portion 312, an engagement portion 348, and a flange 350. The first side 308 is coupled to the second side 310 via the hinge portion 312. In some embodiments, the hinge portion 312 is a living hinge that can bend, flex, and / or otherwise reconfigure to allow the first side 308 to be moved (e.g., hinged, pivoted, or at least partially rotated) relative to the second side 310, and vice versa. In some embodiments, the hinge portion 312 can be a living hinge that includes or is formed by a material different from a material of the first and second sides 308, 310. The material of the living hinge can be flexible, malleable, ductile, etc., to withstand movement of the grip 300 between the open configuration and the closed configuration. Alternatively, as shown in the embodiment of FIGS. 8-11, the hinge portion 312 can include one or more springs (e.g., springs 352, 354) that can, for example, bias the grip 300 in or to an open configuration. The springDocket No.: VDYN-048 / 01WO 336983-2225352 is positioned on a first side of the hinge portion 312 (e.g., adjacent to the first face 320) and the spring 354 is positioned on a second side of the hinge portion 312 (e.g., adjacent to the second face 322).

[0063] The grip 300 includes the flange 350 and the engagement portion 348 to aid and / or facilitate interaction with a user of the grip 300. For example, the engagement portion 348 can include raised portions 356 such as ribs, ridges, protrusions, etc., which may have silicone and / or rubber portions to promote friction between a hand of the user and the grip 300. The raised portions 356 at least partially surround the cylindrical body of the grip 300 in a circumferential direction. Further, the raised portions 356 are spaced apart from one another along the longitudinal direction of the grip 300 from the first face 320 to the second face 322. Alternatively, the engagement portion 348 can include any suitable surface feature, finish, material, configuration, etc. configured to enhance the grip or ergonomics of the grip 300.

[0064] The flange 350 extends away from the cylindrical body of the grip 300 and includes and / or forms the first face 320 of the grip 300. Similarly stated, the flange 350 extends away from the proximal end portion of the cylindrical body of the grip 300. In some embodiments, the flange 350 can provide further engagement with the hand (e.g., at least one knuckle of the hand, the palm of the hand, one or more sides of the hand, etc.) as the user grips, pushes, moves, etc., the grip 300. As such, the flange 350 and the engagement portion 348 aid movement of the grip 300 as the grip 300 is used to advance one or more catheters.

[0065] As described above with reference to the grip 100 and / or the grip 200, the first side 308 of the grip 300 includes a first inner surface 314 having a first groove 316 and a second groove 318. The first and second grooves 316, 318 extend along a length of the grip 300 from the first face 320 to the second face 322. Similarly, the second side 310 includes a second inner surface 324 having a third groove 326 and a fourth groove 328. The third and fourth grooves 326, 328 extend along the length of the grip from the first face 320 to the second face 322. The first and third grooves 316, 326 define a first opening or channel 330 that extends through the grip 300 when in the closed configuration between the first face 320 and the second face 322, and the second and fourth grooves 318, 328 define the second opening or channel 332 that extends through the grip 300 when in the closed configuration between the first face 320 and the second face 322. The grip 300 includes liners 358, 360, 362, 364 (“liner”) disposed within respective first, second, third, and fourth grooves 316, 318, 326, 328 to promote friction and / or gripping between the grip 300 and outer surfaces of one or more catheters.Docket No.: VDYN-048 / 01WO 336983-2225

[0066] As described in detail above with reference to the grip 100 and / or 200, the grip 300 can be used to facilitate transcatheter delivery of a prosthetic heart valve. For example, a transcatheter delivery process can include preparing a control device by releasably coupling a prosthetic valve to a distal end portion of a control catheter, transitioning the prosthetic valve to a compressed configuration, loading the prosthetic valve into a capsule or transfer device, and advancing the prosthetic valve into a proximal end of a delivery catheter. The control catheter can extend through an advancement catheter, which can facilitate the advancement of the control catheter and prosthetic valve through the delivery catheter, as described above with reference to FIG. 5. In some implementations, with the compressed valve at or near a proximal portion of the delivery catheter, the grip 300 can be used to push the advancement catheter and the control catheter to advance the compressed valve within the delivery catheter to or near a distal end portion of the delivery catheter. For example, the grip 300 can be manipulated to position the grip 300 (e.g., in an open configuration) about a portion of the advancement catheter and transitioned to a closed configuration so that the portion of the advancement catheter is disposed within the first opening or channel 330 of the grip 300. Accordingly, as described in detail above with reference to the grip 100 shown in FIGS. 1-6, a distally directed force can be exerted on the grip 300 to advance the advancement catheter, the control catheter, and the prosthetic valve releasably coupled to the control catheter through the lumen of the delivery catheter.

[0067] Similarly, once the compressed valve is in the desired position (e.g., a distal position within the delivery catheter), the securement between the control catheter and the advancement catheter can be released, allowing the control catheter to be moved relative to the advancement catheter. The grip 300 can then be manipulated to position the grip 300 (e.g., in an open configuration) about a portion of the control catheter (e.g., a proximal portion of the control catheter that is proximal to the advancement catheter) and transitioned to the closed configuration so that the portion of the control catheter is disposed within the second first opening or channel 332 of the grip 300. Accordingly, as described in detail above with reference to the grip 100 shown in FIGS. 1-6, a distally directed force can be exerted on the grip 300 to advance the control catheter through the lumen of the advancement catheter and the lumen of the delivery catheter. The distal movement of the control catheter can release the prosthetic valve from the delivery catheter and into a chamber of the heart (e.g., an atrium), which can allow at least a portion of the prosthetic valve to expand. The delivery system can then be manipulated to deploy the prosthetic valve (e.g., via the control catheter and any otherDocket No.: VDYN-048 / 01WO 336983-2225suitable portion of the delivery system) in the annulus of the native heart valve. Accordingly, the grip 300 can be similar, in at least form and / or function to the grip 100 and / or the grip 200 described in detail above.

[0068] FIG. 12 is a flowchart illustrating a method 10 for facilitating transcatheter delivery of a prosthetic heart valve using, for example, a grip device, according to an embodiment. In transcatheter delivery of devices such as, for example, prosthetic heart valves, a diameter of a patient’s vasculature determines or restricts a size (diameter) of a delivery catheter, which in turn, determines or restricts a size of a device, catheter, and / or the like that can be delivered through the delivery catheter. In transcatheter delivery of prosthetic heart valves, the size of the valve, a length of the delivery catheter, and / or other practical considerations, can result in relatively large forces being exerted on portions of a delivery system to advance a prosthetic heart valve through a delivery catheter and into the heart for deployment in an annulus of a native heart valve. As such, it may be desirable to use any of the grip devices described herein to facilitate the application of the forces associated with delivery.

[0069] In some embodiments, a delivery system for transcatheter delivery of a medical device such as a prosthetic heart valve includes, inter alia, a delivery catheter, a first catheter, a second catheter, and a grip device. The delivery catheter can be, for example, a 24-36 French catheter that is inserted into a body of a patient and advanced to a desired location. For example, in some instances, the delivery catheter can be inserted into a femoral vein of the patient and advanced (e.g., along a placed guidewire) through the vasculature until a distal end portion of the delivery catheter is disposed in an atrium of the heart (e.g., the right atrium via the inferior vena cava). In other instances, the delivery catheter can be inserted into a jugular vein and advanced into the atrium (e.g., via the superior vena cava).

[0070] Although not shown in FIG. 12, in some embodiments, the method 10 can include releasably coupling the second catheter to a portion of the prosthetic heart valve and transitioning the prosthetic heart valve to a compressed configuration. In some implementations, the second catheter can be a control catheter having a connection member, coupling member, and / or the like configured to be in contact with and at least temporarily coupled to a supra-annular portion of the prosthetic heart valve. For example, a distal end portion of the control catheter can include a yoke that is releasably coupled to a supra-annular portion of the prosthetic valve via one or more sutures, tethers, couplers, etc. The second catheter can extend through a lumen of the first catheter (e.g., an advancement catheter) such that the prosthetic valve is disposed outside of and distal (or substantially distal) to a distal endDocket No.: VDYN-048 / 01WO 336983-2225of the advancement catheter, as described in detail above with respect to specific embodiments. In some implementations, the prosthetic valve can be transitioned to the compressed configuration by folding or compressing the prosthetic valve in a lateral direction (e.g., at or along a longitudinal axis) and compressing the prosthetic valve in a vertical or blood flow direction (e.g., along a central axis). In some implementation, one or more fixture(s), device(s), mechanism(s), etc. can be used to facilitate the compressing of the prosthetic valve to the compressed configuration.

[0071] As shown in FIG. 12, the method 10 includes loading the prosthetic valve in the compressed configuration into a lumen of a delivery catheter, at 11. For example, the prosthetic valve in the compressed configuration can be loaded into a capsule, loader, transfer device, etc. that is configured to facilitate the insertion or loading of the prosthetic valve into the proximal end portion of the delivery catheter. The loading of the prosthetic valve can be such that a distal end portion of the first catheter and a distal end portion of the second catheter are also loaded or disposed in the proximal end portion of the delivery catheter.

[0072] The method 10 includes manipulating the grip device such that a proximal portion of the first catheter (e.g., the advancement catheter) is disposed in and frictionally engaged by the first channel of the grip, at 12. For example, the grip device can be similar to or substantially the same as any of the grips described herein (e.g., the grip 100, 200, and / or 300). The grip device (also referred to herein as “grip”) can have include a first side and a second side that are movably coupled via one or more hinges. An inner surface of the first side forms or defines a first groove and a second groove and an inner surface of the second side forms or defines a third groove and a fourth groove. The one or more hinges are configured to allow or enable the grip to be transitioned or moved between an open configuration and a closed configuration. In some embodiments, the arrangement of the one or more hinges can be such that the grip is biased in the open configuration. The manipulating of the grip can include, for example, positioning the grip in the open configuration about, around, or relative to the proximal portion of the first catheter and exerting a force (e.g., a compressive force) on an outer surface of the grip to transition the grip to the closed configuration (e.g., the move or transition the grip at the one or more hinges to bring the inner surfaces of the first and second sides together). The proximal portion of the first catheter can include a portion of the first catheter that is proximal to and outside of the delivery catheter.

[0073] When the grip is in the closed configuration, the first groove and the third groove collectively form the first channel and the second groove and the fourth groove collectivelyDocket No.: VDYN-048 / 01WO 336983-2225form the second channel. The first channel can be sized, shaped, and / or configured to receive and engage an outer surface of the first catheter (e.g., the advancement catheter) and the second channel can be sized, shaped, and / or configured to receive and engage an outer surface of the second catheter (e.g., the control catheter), as described in detail above with reference to the grip 100, 200, and / or 300. In some embodiments, the first channel can have a diameter that is larger than a diameter of the second channel. In some embodiments, the grooves can include a relatively soft liner, coating, and / or the like configured to increase an amount of friction associated with the first channel engaging the outer surface of the first catheter and / or the second channel engaging the outer surface of the second catheter.

[0074] A distally directed force is exerted on the grip to advance each of the first catheter, the second catheter, and the prosthetic valve through the lumen of the delivery catheter to a position at a distal end portion of the delivery catheter, at 13. For example, with the proximal portion of the first catheter disposed in the first channel of the grip (e.g., in the closed configuration), the first channel (or collectively the surfaces of the first groove and the third groove) frictionally engage the outer surface of the first catheter. The friction associated with the engagement can be sufficient to limit or substantially prevent movement of the grip relative to or along the first catheter. Thus, at least a portion of the distally directed force exerted on the grip is transmitted and / or transferred to the first catheter, which in turn, is moved in the distal direction within the lumen of the delivery catheter. In some embodiments, the delivery system can include a securement feature, coupler, collet, and / or the like configured to selectively and / or temporarily secure or could the second catheter to the first catheter. As such, the securement feature, coupler, collet, and / or the like can selectively and / or temporarily retain the relative positions between the first catheter and the second catheter. Thus, with the distal end portion of the second catheter coupled to the compressed prosthetic valve, at least a portion of the distally directed force exerted on the grip is operable to advance each of the first catheter, the second catheter, and the prosthetic valve through the lumen of the delivery catheter.

[0075] In some instances, it may be desirable to position the grip about the control catheter at a position that is relatively close to a proximal end of the advancement catheter. As such, the process or step of exerting the distally directed force on the grip can be repeated any number of times to move or advance the first catheter, the second catheter, and the prosthetic valve through the delivery catheter. As described in detail above with reference to the delivery system 102, the first catheter can have a predetermined or known length that is shorter than a length of the delivery catheter. In some instances, the distally directed force can be exerted on the gripDocket No.: VDYN-048 / 01WO 336983-2225to fully advance the first catheter through the delivery catheter. With the predetermined or known length of the first catheter being shorter than the predetermined or known length of the delivery catheter, fully advancing the first catheter can place the prosthetic valve in a predetermined, known, predictable, and / or repeatable position at, near, and / or along the distal end portion of the delivery catheter.

[0076] With the prosthetic valve in the desired position at, near, and / or along the distal end portion of the delivery system, the method 10 further includes manipulating the grip such that a proximal portion of the second catheter is disposed in and frictionally engaged by the second channel of the grip, at 14. More specifically, the manipulation of the grip can include releasing at least a portion of the compressive force exerted on the grip that otherwise maintains the grip in the closed configuration. As such, the grip can be allowed to transition to or toward the open configuration and then moved to a desired position relative to the second catheter. The compressive force can again be exerted on the grip to transition the grip to the closed configuration (e.g., with the proximal portion of the second catheter disposed in and frictionally engaged by the second channel). In some implementations, prior to or in conjunction with manipulating the grip, the securement and / or coupling between the first catheter and the second catheter can be released, allowing relative movement therebetween.

[0077] A distally directed force is exerted on the grip to advance the second catheter (e.g., the control catheter with the compressed prosthetic valve releasably coupled to the distal end portion thereof) relative to the first catheter and release the prosthetic valve from the distal end portion of the delivery catheter, at 15. For example, the distally directed force exerted on the second catheter can move the second catheter in a distal direction through and / or relative to the first catheter and out of and distal to the delivery catheter, thereby releasing the prosthetic valve into the atrium of the heart. The prosthetic valve can be configured and / or allowed to transition from the compressed configuration to an expanded configuration when released or positioned in the atrium. With the prosthetic valve released from the delivery catheter and disposed in the atrium, the grip can be manipulated to disengage or release the second catheter (e.g., by releasing the compressive force exerted on the outer surface of the grip). The second catheter (e.g., a flexible and / or steerable control catheter) can then be manipulated to deploy the prosthetic valve in an annulus of a native heart valve (e.g., a native tricuspid valve). Once the prosthetic valve is deployed, seated, and / or secured in the annulus, the second catheter can be released or decoupled from the prosthetic valve and the delivery system can be withdrawn from the patient.Docket No.: VDYN-048 / 01WO 336983-2225

[0078] The specific terminology used herein is for the purpose of describing particular embodiments and / or features or components thereof and is not intended to be limiting. While various schematics, embodiments, and / or implementations have been described above, it should be understood that they have been presented by way of example only, and not limitation. Various modifications, changes, and / or variations in form and / or detail may be made without departing from the scope and / or spirit of the disclosure and / or without altering the function and / or advantages thereof unless expressly stated otherwise. Likewise, while embodiments (and / or features, components, configurations, aspects, etc. thereof) may be described above in the context of certain implementations, it should be understood that such implementations are presented by way of example only, and not limitation. Any of the embodiments (and / or features, components, configurations, aspects, etc. thereof) can be used in, and / or adapted for use in, other implementations unless expressly stated otherwise. Functionally equivalent embodiments, implementations, and / or methods, in addition to those described herein, will be apparent to those skilled in the art from the foregoing descriptions and are intended to fall within the scope and / or spirit of the disclosure.

[0079] Where schematics, embodiments, and / or implementations described above indicate certain components arranged in certain orientations, configurations, or positions, the arrangement of components may be modified. Although various embodiments have been described as having particular features, configurations, and / or combinations of components, other embodiments are possible having a combination of any features, configurations, and / or components from any of embodiments described herein, except mutually exclusive combinations. The embodiments described herein can include various combinations and / or sub-combinations of the functions, components, configurations, and / or features of the different embodiments described.

[0080] The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired or intended usage. Thus, it should be understood that the size, shape, and / or arrangement of the embodiments and / or components thereof can be adapted for a given use unless the context explicitly states otherwise.

[0081] Where methods described above indicate certain events, steps, and / or procedures occurring in certain order, the ordering of certain events, steps, and / or procedures may beDocket No.: VDYN-048 / 01WO 336983-2225modified. Additionally, certain of the events, steps, and / or procedures may be performed concurrently in a parallel process, when possible, as well as performed sequentially as described above. While methods have been described as having particular steps and / or combinations of steps, other methods are possible having a combination of any steps from any of methods described herein, except mutually exclusive combinations and / or unless the context clearly states otherwise.

Claims

Docket No.: VDYN-048 / 01WO 336983-2225What is claimed is:

1. A grip device for facilitating transcatheter delivery of medical devices, the grip device comprising:a first side comprising a first inner surface having a first groove and a second groove, the first groove and the second groove extending along a longitudinal axis from a distal end to a proximal end of the first side;a second side comprising a second inner surface having a third groove and a fourth groove, the third groove and the fourth groove extending along the longitudinal axis from a distal end to a proximal end of the second side; anda hinge movably coupling the first side to the second side to allow the grip device to be transitioned between an open configuration and a closed configuration,wherein the grip device in the closed configuration being such that the first groove and the third groove collectively form a first channel sized to receive and engage an outer surface of a first catheter and the second groove and the fourth groove collectively form a second channel having a diameter smaller than a diameter of the first channel to receive and engage an outer surface of a second catheter.

2. The grip device of claim 1, wherein the hinge is configured to movably couple the first side and the second side such that the grip device is biased toward the open configuration.

3. The grip device of claim 1, wherein the hinge comprises at least one spring or at least one living hinge.

4. The grip device of claim 1, wherein each groove comprises a liner configured to frictionally engage one of the first catheter or the second catheter.

5. The grip device of claim 1, wherein the first catheter is an advancement catheter and the second catheter is a control catheter, the control catheter extending through the advancement catheter, a distal end portion of the control catheter configured to be releasably coupled to a prosthetic heart valve.Docket No.: VDYN-048 / 01WO 336983-22256. The grip device of claim 1, wherein an outer surface of the first side and an outer surface of the second side collectively form a cylindrical body of the grip device when the grip device is in the closed configuration.

7. The grip device of claim 6, wherein the outer surfaces of the first side and the second side collectively form a flange at a distal end portion of the grip device.

8. A delivery system for transcatheter delivery of a prosthetic heart valve, the delivery system comprising:a delivery catheter defining a lumen having an inner diameter configured to receive the prosthetic heart valve in a compressed configuration;an advancement catheter defining a lumen, the advancement catheter having an outer diameter smaller than an inner diameter of the delivery catheter;a control catheter including a coupling member at a distal end configured to releasably couple to the prosthetic heart valve, the control catheter having an outer diameter that is smaller than the inner diameter of the advancement catheter; anda grip device comprising a first side movably coupled to a second side via a hinge to allow the grip device to transition between an open configuration and a closed configuration, the first side of the grip device having a first inner surface defining a first groove and a second groove extending from a distal end to a proximal end of the first side, the second side of the grip device having a second inner surface defining a third groove and a fourth groove extending from a distal end to a proximal end of the second side,the grip device in the closed configuration being such that (i) the first groove and the third groove collectively form a first channel sized to receive and engage the advancement catheter, and (ii) the second groove and the fourth groove collectively form a second channel sized to receive and engage the control catheter.

9. The delivery system of claim 8, wherein the first channel has a first diameter and the second channel has a second diameter smaller than the first diameter.

10. The delivery system of claim 8, wherein the hinge is configured to bias the grip device toward the open configuration to allow the grip device to be disposed about the advancement catheter and the control catheter.Docket No.: VDYN-048 / 01WO 336983-222511. The delivery system of claim 10, wherein the hinge comprises at least one spring or at least one living hinge.

12. The delivery system of claim 8, wherein an outer surface of the first side and an outer surface of the second side collectively form a cylindrical body of the grip device when the grip device is in the closed configuration.

13. The delivery system of claim 12, wherein the outer surfaces of the first side and the second side collectively form a flange at a distal end portion of the grip device.

14. A method for facilitating transcatheter delivery of a prosthetic heart valve using a grip device, the grip device comprising a first side and a second side coupled to the first side by a hinge, the first side and the second side collectively forming a first channel and a second channel, the method comprising:loading the prosthetic heart valve in a compressed configuration into a lumen of a delivery catheter of a delivery system, the delivery system including a first catheter and a second catheter extending through the first catheter, a distal end portion of the second catheter being distal to the first catheter and releasably coupled to the prosthetic heart valve;manipulating the grip device such that a proximal portion of the first catheter is disposed in and frictionally engaged by the first channel, a distal portion of the first catheter being disposed in the lumen of the delivery catheter, the proximal portion of the first catheter being disposed outside of and proximal to the delivery catheter;exerting a distally directed force on the grip device to advance each of the first catheter, the second catheter, and the prosthetic heart valve through the lumen of the delivery catheter to position the prosthetic heart valve at a distal end portion of the delivery catheter;manipulating the grip device such that a proximal portion of the second catheter is disposed in and frictionally engaged by the second channel, the proximal portion of the second catheter being disposed outside of and proximal to the first catheter; andexerting a distally directed force on the grip device to advance the second catheter relative to the first catheter and release the prosthetic heart valve from the distal end portion of the delivery catheter.Docket No.: VDYN-048 / 01WO 336983-222515. The method of claim 14, wherein the manipulating the grip device such that the proximal portion of the first catheter is disposed in and frictionally engaged by the first channel comprises:positioning the grip device in an open configuration about the proximal portion of the first catheter, andexerting a compressive force on the grip device to transition the grip device from the open configuration to a closed configuration such that the proximal portion of the first catheter is disposed in and frictionally engaged by the first channel.

16. The method of claim 15, wherein the hinge is configured to bias the grip device in the open configuration, the manipulating the grip device such that the proximal portion of the second catheter is disposed in and frictionally engaged by the second channel comprises: releasing the compressive force on the grip device to allow the grip device to transition to the open configuration,positioning the grip device in the open configuration about the proximal portion of the second catheter, andexerting the compressive force on the grip device to transition the grip device from the open configuration to the closed configuration such that the proximal portion of the second catheter is disposed in and frictionally engaged by the second channel.

17. The method of claim 14, wherein:the first side of the grip device comprises a first inner surface having a first groove and a second groove that extend in a direction along a longitudinal axis of the grip device, the second side of the grip device comprises a second inner surface having a third groove and a fourth groove that extend in the direction along the longitudinal axis, and the grip device is configured to transition, via the hinge, between an open configuration and a closed configuration, the grip device in the closed configuration being such that the first groove and the third groove collectively define the first channel and the second groove and the fourth groove collectively define the second channel.

18. The method of claim 17, wherein each groove of the grip device comprises a liner configured to frictionally engage one of the first catheter or the second catheter.

19. The method of claim 14, further comprising:Docket No.: VDYN-048 / 01WO 336983-2225releasably coupling the distal end portion of second catheter to a portion of the prosthetic heart valve; andtransitioning the prosthetic heart valve from an expanded configuration to the compressed configuration by folding the prosthetic heart valve along a longitudinal axis of the prosthetic heart valve and compressing the prosthetic heart valve along a vertical axis that is perpendicular to the longitudinal axis.

20. The method of claim 14, further comprising:manipulating the grip device to disengage the second catheter after the prosthetic heart valve is released from the distal end portion of the delivery device.

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