Systems and methods for folding and loading a prosthetic device

Abstract

Systems and methods are provided for collapsing and loading a prosthesis for delivery to a patient. The collapsing and loading systems described herein can facilitate more efficient and consistent positioning of a prosthesis with respect to a collapsor system and a corresponding delivery system. For example, the system can include a collapsor system having a base and a collapsor movably coupled to the base. The collapsor can define an orifice sized and shaped to receive a prosthesis (e.g., a prosthetic heart valve) at a first position and can be moved relative to the base to a second position for loading and collapsing the prosthesis onto the delivery system.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to systems and methods for manipulating implantable prosthetic devices, such as artificial heart valves, during pre-operative procedures prior to implantation of such devices. [Background technology]

[0002] In the field of heart valve surgery and interventional cardiology, the easy handling of medical devices and the reduction of the time required to perform safe and precise surgical interventions and procedures are central interests of medical and technological research. In connection with the implantation of expandable prosthetic heart valves, such as sutureless prosthetic heart valves, current practice dictates that prosthetic heart valves may need to be radially folded and connected to a delivery tool in order to be delivered to the patient's implantation site, e.g., in minimally invasive or percutaneous procedures. Folding an implantable prosthesis may present several significant challenges. Although devices have been devised to facilitate the folding operation, the operation may be rather poor and complicated to perform.

[0003] Examples of previously known systems for folding prosthetic devices, such as prosthetic heart valves, are described in U.S. Pat. No. 8,006,535 to Righini, U.S. Pat. No. 9,114,010 to Gaschino, U.S. Pat. No. 9,788,931 to Giordano, and U.S. Patent Application Publication No. 2021 / 0196442 to Giordano, each of which is assigned to the assignee of the present invention, the entire contents of each of which are incorporated by reference into this specification.

[0004] One challenge faced by practitioners when folding a prosthesis onto a delivery system is achieving the desired positioning, especially angular and longitudinal positioning, of the prosthesis with respect to both the folding system and the associated delivery system. In various prior art embodiments, the delivery system may provide indicia (e.g., markers intended to identify the commissures of the aortic or tricuspid valve) to assist the practitioner in correctly positioning the prosthesis at the implantation site. However, these embodiments may entail the risk of damaging the prosthesis when the practitioner adjusts its angular position within the orifice of the folding system by directly manipulating the prosthesis. Moreover, these embodiments still often require manual, and potentially time-consuming, orientation of the prosthesis with respect to other system components during the folding operation. Also, the system may not simultaneously facilitate axial and longitudinal alignment of the prosthesis with respect to both the folding and delivery systems.

[0005] Another challenge is to innovatively maintain the prosthesis in a folded state as the folding operation progresses from start to finish. Current systems include multi-stage folding operations, but these systems may not adequately maintain the prosthesis in a folded configuration on the delivery system.

[0006] Yet another challenge involves the problematic system configurations that are often required for initial loading of a prosthesis into the collapsor system: In various prior art embodiments, the prosthesis may only be loaded from the side of the collapsor system, which may further necessitate the use of additional holder devices.

[0007] In light of the foregoing, it is desirable to provide a system and method for collapsing and loading a prosthesis for delivery to a patient while facilitating more efficient and consistent positioning of the prosthesis relative to a collapsor system and associated delivery system.

[0008] It would further be desirable to provide a system and method for ensuring that the prosthesis remains collapsed on the delivery system after use of the collapsor system.

[0009] It further remains desirable to provide a system and method for simplified, user-friendly loading of a prosthesis into a collapsor system. Summary of the Invention

[0010] Provided herein are systems and methods for collapsing and loading a prosthesis in preparation for delivery to a patient. For example, the system may be a kit / pack of accessories provided with a prosthesis to enable a clinician to implant the prosthesis. In various embodiments, the present disclosure provides a means to make manipulation of an implantable prosthesis easier, safer, faster, and more accurate compared to previously known systems and methods. For example, provided herein are systems and methods for collapsing and loading a prosthesis (e.g., a prosthetic heart valve) onto a delivery system in an efficient and consistent manner. Preferably, the exemplary collapsor system allows the prosthesis to remain collapsed on the delivery system after use of the collapsor system to facilitate delivery of the collapsed prosthesis. The collapsor system also allows for simplified, user-friendly loading of the prosthesis (e.g., top loading) into the collapsor system, and further, simplified, user-friendly loading of the delivery system (e.g., side loading) to allow the prosthesis to be collapsed in preparation for delivery to a target implantation site, such as a congenitally defective heart valve.

[0011] According to some aspects, a system may include a collapsor system having a base and a collapsor movably coupled to the base. The collapsor preferably defines an orifice sized and shaped to receive the prosthesis in an expanded state when the collapsor is in a first position (e.g., a prosthesis loading position) relative to the base. The collapsor may be configured to move from the first position to a second position (e.g., a delivery device loading position) such that the orifice is oriented relative to the base in a different manner than in the first position. For example, the collapsor system may be designed to allow top loading of the prosthesis into the orifice of the collapsor in the first position, to allow movement of the collapsor relative to the base from the first position to a second position (e.g., from a horizontal position to a vertical position), and to allow side loading of a delivery system into the orifice of the collapsor in the second position. The collapsor may be further configured to reduce a size of the orifice from the first size to the second, smaller size to collapse the prosthesis on a delivery system while the collapsor is in the second position, thereby preparing the prosthesis for delivery to a patient in the collapsed state via the delivery system.

[0012] The collapsor may further include an actuator configured to, upon actuation, cause the collapsor to reduce the size of the orifice from the first size to the second smaller size such that the prosthesis is loaded into the delivery system in the collapsed state. The actuator may be configured to, upon further actuation, cause the collapsor to increase the size of the orifice from the second smaller size to the first size such that the prosthesis remains collapsed in the delivery system. In this manner, the delivery system with the collapsed prosthesis coupled thereto may be pulled out of the collapsor orifice to enable implantation of the prosthesis using the delivery system. The actuator may include a handle that is grasped and moved by a user for actuation. Additionally, the collapsor system may further include a movable base coupled to the collapsor and movably coupled to the base. A portion of the base may extend below the movable base. The collapsor may further enable top loading of the expanded prosthesis into the orifice in the first position and enable side loading of the delivery system through the orifice in the second position. The first position of the collapsor may further be substantially orthogonal to the second position (e.g., horizontal vs. vertical relative to the base).

[0013] The collapsor system may further include a lock configured to maintain the collapsor in the first position via an interface with the base. The lock may be releasable upon application of a predetermined force toward the second position. The lock may further include a flexible protrusion extending from the base and engaging a recess in an upper portion of the housing of the collapsor. The flexible protrusion may be configured to deflect upon application of the predetermined force to release the recess. The collapsor system may further include a ledge extending upwardly from the base. The ledge may be configured to contact the collapsor and securely maintain the collapsor in the first position. The collapsor system may further include a base lock configured to maintain the collapsor in the second position via an interface with the base.

[0014] The collapsing system may further include a handle support configured to support a handle of the delivery system while a distal portion of the delivery system is inserted into the orifice to collapse the prosthesis. The handle support may further include an alignment mechanism configured to engage a corresponding mechanism of the handle of the delivery system to longitudinally and axially align the delivery system during collapse of the prosthesis.

[0015] The collapsor may further include a housing configured to accommodate first and second collapsor sectors, each having a plurality of collapsor sector portions. The collapsor sector portions may be configured to move upon actuation to reduce the size of the orifice from the first size to the second smaller size. The collapsor may further include first and second annular bodies configured for relative rotation about an axis. The first and second annular bodies may each have a plurality of radially spaced curvilinear holes for receiving components of the first and second collapsor sectors, respectively. In some embodiments, the plurality of radially spaced curvilinear holes of the first and second annular bodies may be configured to self-lock when the first and second collapsor sectors are in positions corresponding to the second smaller size. A handle may further be coupled to the first and second annular bodies. For example, half of the handle may be integrally formed with the first and second annular bodies, respectively. The collapsor may further include a collapsor center frame configured to be positioned in the housing between the first and second annular bodies. The collapsor may further include a plurality of protrusions extending into the orifice and defining a void therebetween to facilitate alignment of the prosthesis within the orifice. The collapsor may further prevent a component at a distal portion of the delivery system (e.g., a sheath and / or a distal tip) from transitioning completely to the delivery state when the orifice is reduced to the second, smaller size.

[0016] Optionally, the system may further include components beyond the collapsor system. For example, the system may further include a delivery system. The system may further include a balloon catheter configured to expand the prosthesis after deployment from the delivery system. The system may further include the prosthesis. In a preferred embodiment, the prosthesis is a prosthetic heart valve.

[0017] According to another aspect of the present disclosure, a method for collapsing a prosthesis for delivery to a patient is provided, the method may include loading a prosthesis into an orifice of a collapsor while the collapsor is in a first position relative to a base, moving the collapsor from the first position to a second position while the base remains in place, inserting a distal portion of a delivery system through the prosthesis loaded in the orifice, and folding the prosthesis through the collapsor and onto the distal portion of the delivery system to prepare the prosthesis for delivery to a patient via the delivery system in a collapsed state. The method may further include, after collapsing the prosthesis, actuating the delivery system to move proximal and distal components of the delivery system toward one another to hold proximal and distal ends of the prosthesis in the collapsed state; and transitioning the collapsor from a smaller sized orifice to a larger sized orifice such that the prosthesis remains coupled to the distal portion of the delivery system in the collapsed state. Transitioning the collapsor from the smaller sized orifice to the larger sized orifice may further cause the proximal and distal components of the delivery system to move closer toward one another to securely hold the prosthesis in the collapsed state for delivery to the patient. The method may further include delivering the folded prosthesis to a target implantation site (e.g., the location of a defective heart valve that may have been surgically removed) using a delivery system, and transitioning the folded prosthesis from the folded state to an expanded state to implant the prosthesis at the target implantation site. [Brief description of the drawings]

[0018] [Figure 1] 1 illustrates an exemplary system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure.

[0019] [Figure 2A] 1 illustrates an exemplary collapsor system associated with a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 2B] 1 illustrates an exemplary collapsor system associated with a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 2C] 1 illustrates an exemplary collapsor system associated with a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 2D] 1 illustrates an exemplary collapsor system associated with a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 2E] 1 illustrates an exemplary collapsor system associated with a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 2F] 1 illustrates an exemplary collapsor system associated with a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure.

[0020] [Figure 2G] 1 illustrates an exemplary annulus of a collapsor system that includes structure for self-locking the collapsor when the orifice is in a collapsed position.

[0021] [Figure 2H] 1 illustrates various self-locking structures that may be incorporated into the collapsor system. [Figure 2I] 1 illustrates various self-locking structures that may be incorporated into the collapsor system. [Figure 2J] 1 illustrates various self-locking structures that may be incorporated into the collapsor system.

[0022] [Figure 3A]1 illustrates an exemplary delivery system related to a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 3B] 1 illustrates an exemplary delivery system related to a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 3C] 1 illustrates an exemplary delivery system related to a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 3D] 1 illustrates an exemplary delivery system related to a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 3E] 1 illustrates an exemplary delivery system related to a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 3F] 1 illustrates an exemplary delivery system related to a system for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure.

[0023] [Figure 4A] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4B] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4C] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4D] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4E]1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4F] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4G] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4H] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4I] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. [Figure 4J] 1 illustrates an exemplary system and method for folding and loading a prosthesis for delivery to a patient, according to some aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Provided herein are systems and methods for folding and loading a prosthesis for delivery to a patient, which may therefore be useful for safely and effectively manipulating an implantable prosthesis, such as a prosthetic heart valve, during pre-operative procedures prior to implanting such a device. For example, the systems of the present invention may be designed to fold sutureless prosthetic aortic valves, such as the PERCEVAL™ and PERCEVAL™ PLUS devices available from Corcym Srl (Milan, Italy). Examples of prostheses suitable for folding and delivery using the systems described herein include U.S. Pat. No. 7,857,845 to Stacchino and U.S. Patent Application Publication No. 2021 / 0205078 to Carlino, each of which is assigned to the assignee of the present invention and the entire contents of each of which are incorporated herein by reference. The folding and loading systems described herein are intended to facilitate more efficient and consistent positioning of a prosthesis, preferably a prosthetic heart valve, with respect to a collapsor system and associated delivery system for eventual delivery to a patient. Certain embodiments may be further designed, for example, to ensure that the prosthesis remains collapsed on the delivery system at a relative degree with respect to the current positioning of the collapsor system and / or to provide for top loading of the prosthesis into the collapsor system while the collapsor is in a procedural pre-folding orientation, either of which may facilitate more desirable functionality for practitioners.

[0025] 1, an exemplary system 100 for collapsing and loading a prosthesis for delivery to a patient is provided. System 100 preferably includes a collapsor system 200 and may optionally further include components for delivering the prosthesis to a patient, such as a delivery system 300 and / or a balloon catheter 400. In some embodiments, system 100 is a kit / pack of accessories provided with a prosthesis to enable a clinician to implant the prosthesis.

[0026] As illustrated, the collapsor system 200 may include a base 202 and a collapsor 204 coupled to the base 202. The collapsor system 200 generally facilitates folding and loading of a prosthesis onto a delivery system while the base 202 serves as a mounting fixture for the collapsor 204, which is the functional center of the folding and loading operation. The base 202 allows the collapsor system 200 to be stably positioned on a surface, such as a table in an operating room, and maintains the collapsor system 200 in a fixed position even while the collapsor 204 is moved between positions throughout the loading / folding process. The collapsor 204 defines an orifice 206 that is sized and shaped to receive the prosthesis in an expanded state. For example, as shown in FIG. 1, the orifice may receive the prosthesis in an initial prosthesis loading position. The collapsor 204 is designed to move relative to the base 202 to facilitate user-friendly and efficient loading of the prosthesis into the orifice 206 in one position, and subsequent insertion of a delivery device and folding of the prosthesis in a different position relative to the base 202. For example, in the second position, the orifice 206 is oriented differently relative to the base 202 than in the first position. The collapsor 204 may further reduce the size of the orifice 206 from a first size to a second, smaller size while the collapsor 204 is in the second position, in order to collapse the prosthesis onto a delivery system, such as exemplary delivery system 300, thereby preparing the prosthesis for delivery to a patient in a collapsed state.

[0027] The collapsor 204 may further include a plurality of protrusions 208 extending radially inward into the orifice 206 and defining a plurality of alignment voids 210 therebetween to facilitate alignment of the prosthesis to the orifice 206. The protrusions 208 may also extend longitudinally outward away from the orifice 206. In this manner, the prosthesis may be loaded into the orifice 206 only when the radially extending portion of the prosthesis is aligned with the voids 210. The protrusions 208 may be radially spaced around the orifice 206 in a predetermined manner. For example, there may be three protrusions 208 equally spaced around the orifice 206 (e.g., 120° apart from the center). The collapsor 204 may further include a plurality of arm supports 211 extending radially inward into the orifice 206. As illustrated, the arm supports 211 are each positioned in a respective cavity 210 and are longitudinally offset from the respective cavity 210. For example, the arm supports 211 may be longitudinally central to the orifice 206, while the projections 208 and the cavity 210 may be at an end of the orifice 206, such as the top loading end in a first position. Similar to the projections 208, the arm supports 211 may be radially spaced around the orifice in a predetermined manner, for example, there may be three arm supports 211 equally spaced around the orifice 206 (e.g., 120° apart from the center). The arm supports 211 are designed to contact radially extending portions of the prosthesis (e.g., fixation arms) to facilitate loading and folding of the prosthesis.

[0028] The collapsor 204 may include an actuator 212 configured to, upon actuation, cause the collapsor 204 to reduce the size of the orifice 206 from a first size to a second, smaller size. Upon further actuation, the actuator 212 may cause the collapsor 204 to increase the size of the orifice 206 from the second, smaller size to a larger size, which may be the same size as the first size, so that the prosthesis remains collapsed on the delivery system 300 and the delivery system 300 holding the collapsed prosthesis may be pulled from the collapsor. The actuator 212 may be in the form of a collapsor handle 214, which may be held and moved by a user during operation. Alternatively, the actuator 212 may be formed with other mechanisms, such as, for example, a button.

[0029] In addition, the collapsor system 200 may further include a movable base 216 coupled to the collapsor 204 and movably coupled to the base 202, which may facilitate repositioning of the collapsor 204 relative to the base 202 as part of the folding and loading operation. For example, the movable base 216 may be fixed to the collapsor 204 (e.g., via a central frame) while being movable relative to the base 202 (e.g., via a hinge). The collapsor 204 may further allow top loading of the prosthesis in an expanded state into the orifice 206 in a first position and side loading of the delivery system 300 through the orifice 206 in a second position, which will be described in more detail below.

[0030] The system 100 may further include a delivery system 300 onto which the prosthesis may be folded and loaded by a user for delivery to an implantation site in a patient. The delivery system 300 may be constructed in a manner similar to the system described in WO 2019 / 224581 (corresponding to U.S. Ser. No. 17 / 057,502), which is assigned to the assignee of the present invention and is incorporated herein by reference in its entirety. The delivery system 300 may have a proximal portion 302 coupled to a distal portion 304 via a shaft 306. The proximal portion 302 is designed to be positioned outside the patient during an implantation procedure and is manipulated by a user, while the distal portion 304 is configured to receive the folded prosthesis and to be introduced inside the patient to implant the prosthesis during the procedure. The distal portion 304 is sized to be inserted through the prosthesis once loaded into the orifice 206 to fold the prosthesis onto the distal portion 304. Once folded, components at the distal portion 304 may be manipulated to releasably hold and maintain the prosthesis in the folded state for delivery to a patient. The proximal portion 302 may include a handle 308 and / or a handle aligner 310. The handle 308 is sized to be held by a user during operation, while the handle aligner 310 may be used as a temporary fixation point to facilitate longitudinal and axial alignment of the delivery system 300 with respect to the collapsor system 200, as described in further detail below.

[0031] The collapsor system 200 may further include a handle support 218 for supporting the handle 308 of the delivery system 300 while the distal portion 304 is inserted into the orifice 206 for collapsing the prosthesis. The handle support 218 may be formed as part of the base 202 as illustrated, and preferably extends upwardly a distance such that the delivery device 300 remains parallel to the ground contacting portion of the base 202 when the handle 308 is located within the prosthesis at the orifice 206 and the handle support 218 and distal portion 304 are located. The handle support 218 may have a shape that corresponds to the shape of the handle 308 such that the handle support 218 conformably receives the handle 308 in a seated configuration. For example, the handle support 218 may have an elongated recess sized to hold a majority of the handle 308. The handle support 218 may further include a handle support aligner 220 that engages a corresponding handle aligner 310 on the handle 308 of the delivery system 300 to longitudinally and axially align the delivery system 300 during folding of the prosthesis. The handle support aligner 220 may be a protrusion extending from a portion of a recess, and the handle aligner 310 may be a recess that receives the protrusion to longitudinally and axially align the delivery system 300.

[0032] System 100 may further still include a balloon catheter 400 designed to expand the prosthesis at the implantation site after deployment from the delivery system. Balloon catheter 400 includes catheter 402 and balloon 404 for expanding the prosthesis as a further step of implantation.

[0033] 2A-2F, an exemplary collapsor system 200 for collapsing and loading a prosthesis for delivery to a patient is described in further detail. FIG. 2A is an exploded view illustrating exemplary components of the collapsor system 200. As shown in FIG. 2A, the collapsor system 200 includes a collapsor 204 coupled to a base 202. The internal components of the collapsor 204 are held in a collapsor housing 222, which may be formed from one or more pieces, such as collapsor covers 224, 226, as illustrated. The collapsor cover 224 may include protrusions 208 to facilitate desired alignment of the prosthesis within the collapsor 204, as described above. The internal components housed between the collapsor covers 224, 226 may include first and second collapsor sectors 228, 230, first and second annular bodies 234, 236, and / or a central frame 240. As illustrated, the central frame 240 may be in the middle of the collapsor 204 with the first and second annular bodies 234, 236 on either side of the central frame 240. The first and second collapsor sectors 228, 230 are between the first and second annular bodies 234, 236, and the collapsor covers 224, 226, respectively. Each of the components preferably defines a central orifice such that when coupled together, the components define the orifice 206.

[0034] The first and second collapsing sectors 228, 230 may each have a plurality of collapsing sector portions 232. As illustrated, each collapsing sector portion 232 may be an angled plate that narrows at one end. The plurality of collapsing sector portions 232 preferably rotate upon actuation such that they physically restrict the opening of the orifice 206, thus reducing the size of the orifice 206 from a first size to a second, smaller size. The first and second collapsing sectors 228, 230 may each have a plurality of components (e.g., posts) that extend outwardly to engage the respective annulus and / or the respective collapsing cover 224, 226. For example, each collapsing sector portion 232 may include a protruding component at each of its ends.

[0035] The first and second collapsing rings 234, 236 are each designed for relative rotation about an axis in response to actuation. The first and second collapsing rings 234, 236 may each have a plurality of curvilinear, radially spaced holes 238 for receiving components (e.g., posts) of the first and second collapsing sectors 228, 230, respectively. The collapsing handle 214 may further be coupled to or integrally formed with the first and second collapsing rings 234, 236. In this manner, movement of the collapsing handle 214 rotates the rings 234, 236, thereby causing the collapsing sectors 228, 230 to collapse onto their respective ends of the prosthesis without the central portion of the prosthesis contacting the collapsing sectors 228, 230. In this manner, the collapsor system 200 allows for selected portions of a prosthesis to be collapsed.

[0036] The central frame 240 may be coupled (e.g., fixedly coupled) to the movable base 216. The central frame 240 may include arm supports 211 for contacting the fixation arms of the prosthesis during the folding process. The central frame 240 may be positioned between the first and second collapsor annular bodies 234, 236 in the collapsor housing 222. The components of the collapsor housing 222 may be secured via fasteners, such as screws 242.

[0037] The movable base 216 may be coupled to the collapsor 204, for example, via a base pin 244, and may be movably coupled to the main base 202 via a hinge, which may be formed by a connecting hinge 246 and a connecting pin 248. A portion of the base 202, namely the base extension 250, may extend below the movable base 216 while the collapsor 204 is in the second position, forming a fixed surface on which the movable base 216 may temporarily rest during collapsing of the prosthesis and subsequent loading onto a delivery system. The movable base 216 may include a recess in its underside for receiving the base extension 250 when in the second position. The base 202 may further include user instructions 252 illustrating (e.g., via text and / or images) step-by-step instructions for a user to use the collapsor system 200.

[0038] 2B is another exploded view illustrating exemplary components of the collapser system 200. As shown in FIG. 2B, the collapsor covers 224, 226 may include a plurality of curvilinear, radially spaced internal tracks for receiving components (e.g., posts) of the first and second collapsor sectors 228, 230, respectively, to further facilitate secure folding. The plurality of curvilinear, radially spaced internal tracks may correspond to the same shape and orientation as the corresponding curvilinear, radially spaced holes 238 of the first and second collapsor annular bodies 234, 236. Additionally, each of the plurality of collapser sector portions 232 of the first and second collapsor sectors 228, 230 may have a triangular shape (e.g., an obtuse triangular shape), as shown in FIG. 2B.

[0039] FIG. 2C shows a front view of the collapsor system 200 in an initial position for top-loading of a prosthesis. As shown in FIG. 2C, the collapsor system 200 may further include a shelf 254 extending upward from the base 202. The shelf 254 may be integrally formed with the base 202. The shelf 254 preferably contacts the collapsor 204 to securely maintain the collapsor 204 in the first position. For example, the shelf 254 may contact an upper portion of a housing of the collapsor 204 to hold the collapsor in a generally horizontal position for top-loading of a prosthesis. As shown, in the first position, a gap 256 may be defined between the base 202 and the collapsor 204, for example, due to the shelf 254.

[0040] FIG. 2D illustrates a cross-sectional view of the collapsor system 200 of FIG. 2C. As shown in FIG. 2D, the collapsor system 200 may further include a lock 258 for maintaining the collapsor 204 in a first position via coupling with the base 202. The lock 258 may be located upward from the shelf 254 as shown. The lock 258 may be releasable upon application of a predetermined force toward the second position. For example, a user may pull up on a handle of the collapsor 204 with a predetermined force or greater to release the lock 258 for movement to the second position. However, the lock 258 is sufficiently secured such that the collapsor 204 is not unintentionally disengaged from the base 202, for example, during shipping, when a user removes and lifts the collapsor system 200 from its packaging / box, or during top loading. Alternatively or additionally, the lock 258 may be released upon actuation by a user, for example, pressing a button. The lock 258 may include a flexible protrusion 260 extending from the base 202 to engage a collapsor housing recess 262 on the top of the collapsor housing 222. The flexible protrusion 260 may flex upon application of a predetermined force to disengage from the collapsor housing recess 262, thereby releasing the lock 258.

[0041] FIG. 2E shows a front view of the collapsor system 200 in a position for loading a prosthesis onto the delivery system. As shown by comparing FIG. 2E with FIG. 2C, the collapsor 204 has been moved from a first position to a second position. In the second position, the orifice 206 is oriented with respect to the base 202 in a different manner than in the first position. For example, in the first loading position, the longitudinal axis extending through the orifice 206 is perpendicular to the elongated portion of the base 202, while in the second position, the longitudinal axis is parallel to the elongated portion of the base 202. As such, the second position may also be substantially orthogonal to the first position to facilitate top loading of a prosthesis into the orifice 206 when the collapsor 204 is in the first position, and subsequent side loading of a delivery system through the same orifice 206 once the collapsor 204 has been moved to the second position.

[0042] FIG. 2F shows a cross-sectional view of the collapsor system 200 of FIG. 2E. As shown in FIG. 2F, the collapsor system 200 may further include a base lock 264 for maintaining the collapsor 204 in the second position via coupling with the base 202. The base lock 264 may be located at an end of the base 202, e.g., at an end of the base extension 250 for releasable coupling with the movable base 216. The base lock 264 is preferably released upon actuation by a user, e.g., pressing a flexible protrusion to disengage. Alternatively or additionally, the base lock 264 may be releasable upon application of a predetermined force (e.g., using a handle) toward the first position. The base lock 264 may include a flexible protrusion 266 extending from the base 202 (e.g., the base extension 250) for engaging a recess 268 in the movable base 216. The flexible projection 266 may flex upon actuation by a user to disengage and release it from the recess 268, thereby releasing the base lock 268. Preferably, the base lock 264 is only disengaged for unfolding the prosthesis.

[0043] FIG. 2G illustrates an annular body 236' that may be used in the collapsor system 200 to self-lock the collapsor when the orifice is in a collapsed position. The annular body 236' corresponds to the second annular body 236 (or first annular body 234) above, while the multiple radially spaced curved holes 238' of the first and second annular bodies self-lock when the first and second collapsor sectors are in a position corresponding to the second, smaller size of the orifice. For example, the multiple curved, radially spaced holes may include a feature at the end (e.g., proximal end) with a locking system that keeps the collapsor sectors closed at the minimum / collapsed diameter without the need to apply force against the collapsor handle. The feature may be an abrupt change in curvature at the proximal end of the curved holes.

[0044] 2H-2J illustrate various self-locking structures that may be incorporated into the collapsor system. FIG. 2H illustrates a self-lock 270 at the end of the curved hole 238′ where the hole curvature changes to a tangential profile at an inflection point 272. As such, as corresponding components (e.g., posts) of the first and second collapsor sectors 228, 230 move along the curved hole 238′, the components are reoriented to lock the collapsor system 200 in place at the self-lock 270 in the collapsed state without the need to push against the handle. FIG. 2I illustrates an alternative self-lock 274 at the curved hole 238″ where the hole curvature changes to an inverted curve profile at an inflection point 276 compared to the curvature prior to the inflection point 276. 2J illustrates yet another alternative self-lock 278 in curved bore 238''', where the end includes a snap 280 that extends into curved bore 238''' to prevent corresponding components (e.g., posts) of first and second collapsing sectors 228, 230 from moving back along curved bore 238''' without disengaging snap 280 to disengage self-lock 278. As shown in FIG. 2J, the radius of curvature of curved bore 238''' may be maintained along the length of the bore in this embodiment.

[0045] 3A-3F, an exemplary delivery system 300 for delivering an exemplary prosthesis 500 to a patient is provided. FIG. 3A illustrates a perspective view of the delivery system 300 prior to folding and loading a prosthesis thereon. As shown in FIG. 3A, the distal portion 304 of the delivery system 300 may include a sheath 312, a constraining configuration 314, and a distal tip 316 extending in a proximal-to-distal direction along a shaft 306. Prior to folding and loading a prosthesis onto the delivery system 300, the distal portion 304 may receive the prosthesis in an expanded state between the sheath 312 and the distal tip 316 such that the sheath 312 does not contact the prosthesis. Preferably, a frame of the prosthesis is designed to be coupled to the constraining configuration 314.

[0046] 3B shows a perspective view of the delivery system 300 with a prosthesis 500 folded and loaded thereon. Illustratively, the prosthesis 500 is a prosthetic heart valve. As shown in FIG. 3B, the prosthesis 500 may include a frame 502 having anchoring arms 504 extending radially outward. The frame 502 may be structured to facilitate folding and expansion of the prosthesis 500, while the anchoring arms 504 function to position the prosthesis 500 in a preferred location at the patient's delivery site (e.g., where a defective heart valve, such as an aortic valve, was located). The prosthesis 500 may be folded and loaded onto the delivery system 300 between the constraining configuration 314 and the distal tip 316 such that the sheath 312 contracts longitudinally relative to the distal tip 316 so as to maintain one end of the prosthesis 500 (e.g., the outflow end) in a folded state and the distal tip 316 maintains the other end of the prosthesis 500 (e.g., the inflow end) in a folded state, thereby enabling it to be delivered to a patient for implantation.

[0047] 3C shows an exploded view of the delivery system 300. As shown in FIG. 3C, the proximal portion 302 may include a delivery housing 318 and a delivery actuator 320. The delivery actuator 320 is designed to be actuated by a user to cause corresponding movement of components in the distal portion 304 of the delivery system 300. Upon actuation, the sheath 312 may slide longitudinally along the distal portion 304 from the shaft 306 toward the distal tip 316 to facilitate folding of the prosthesis. The delivery actuator 320 may further include a delivery knob 322, which may rest against a delivery cap 324. The delivery knob 322 may be turned by a user to facilitate actuation of the delivery system 300, as described in further detail below.

[0048] 3D shows a cross-sectional perspective view of the delivery system 300 with the prosthesis 500 folded and loaded thereon. As shown in FIG. 3D, the proximal portion 302 of the delivery system 300 may further include an outer slider 326, a spring 328, a pusher 330, an inner slider 332, an inner tube 334, and an outer tube 336, which together are configured to reduce the longitudinal distance between the sheath 312 and the distal tip 316 to the point of engagement of the corresponding end of the prosthesis 500 upon actuation via the delivery actuator 320. The distal portion 304 may further include a delivery bushing 338 and a delivery support 340 to facilitate such actuation.

[0049] FIG. 3E shows a cross-sectional front view of the delivery system 300 prior to folding and loading a prosthesis thereon.

[0050] 3F shows a cross-sectional front view of delivery system 300 with prosthesis 500 folded and loaded thereon. As shown in FIGs. 3E and 3F, spring 328, upon actuation by delivery actuator 320, may urge longitudinally toward distal portion 304, causing corresponding movement of sheath 312 toward distal tip 316 until sheath 312 engages prosthesis 500. Further details regarding delivery system 300 may be found in the above-incorporated WO 2019 / 224581 (corresponding to U.S. Ser. No. 17 / 057,502).

[0051] 4A-4J, an exemplary method for collapsing and loading a prosthesis for delivery to a patient is provided. As shown in FIGs. 4A-4J, a system 100 may be provided with a collapsing system 200 and, optionally, a delivery system 300. System 100 may further optionally include a prosthesis 500, which may be a prosthetic heart valve.

[0052] 4A, a collapsor system 200 is provided. The collapsor system 200 may be in a first position, which may be an initial position. The collapsor system 200 may be supplied in an accessory package / kit provided with a prosthesis to enable a clinician to implant the prosthesis.

[0053] The prosthesis 500 is provided as shown in FIG. 4B. For example, the prosthesis may be provided in a bottle of sterile fluid that is opened in an operating room in a sterile environment. Advantageously, in some embodiments, the prosthesis 500 can be inserted into the collapsor system 200 without any additional components, such as a holder device, being connected thereto. As shown in FIG. 4B, the collapsor system 200 may allow top loading of the prosthesis 500 in an expanded state into the orifice 206 in a first position. The projection 208 and the cavity 210 therebetween allow the user to align the prosthesis 500 for loading into the orifice 206. For example, the projection 208 extends into the orifice 206 such that the anchoring arm 504 extending radially outward is necessarily aligned with the cavity 210 to be inserted into the orifice 206. Upon insertion, the arm supports 211 may contact the respective anchoring arms 504 and limit the depth of loading of the prosthesis 500 into the orifice 206. Thus, the collapsor system 200 may be configured to ensure that the prosthesis 500 is desirably aligned with respect to both the axial orientation and positioning of the inflow end 506 (which may include multiple artificial leaflets) and the outflow end 508 of the prosthesis 500.

[0054] FIG. 4C is a perspective view of the prosthesis 500 loaded into the orifice 206 of the collapsor system 200 prior to collapsing. As shown by comparing FIGS. 4C-4D, the collapsor 204 of the collapsor system 200 has been moved from a first position to a second position shown in FIG. 4D. For example, a user may pull up on the handle 214 of the collapsor system 200 with a predetermined force or greater to release the lock 258 for movement to the second position. Upon application of such force, the flexible projection 260 of the lock 258 flexes and disengages from the collapsor housing recess 262, thereby releasing the lock 258. In the second position, the base lock 264 locks the collapsor 204 in place. For example, a flexible protrusion 266 of a base lock 264 extending from the base 202 (e.g., on the base extension 250) fits into and engages a recess 268 in the movable base 216. Preferably, the base lock 264 is disengaged only if the prosthesis 500 needs to be later re-folded.

[0055] 4E, a delivery system 300 is provided. The delivery system 300 is positioned on the collapsor system 200 to allow the collapsor 204 to collapse the prosthesis 500 onto the delivery system 300. For example, the collapsor 204 may allow side loading of the delivery system 300 through the orifice 206. The handle support 218 supports the handle 308 of the delivery system 300 while the distal portion 304 is inserted through the prosthesis 500 positioned in the orifice 206 to collapse the prosthesis 500.

[0056] FIG. 4F shows a perspective view of the delivery system 300 positioned on the collapsor system 200 in a manner that allows for folding of the prosthesis 500. As shown in FIG. 4F, the collapsor system 200 and the corresponding delivery system 300 are positioned to facilitate accurate folding and loading of the prosthesis 500 onto the delivery system 300. Accordingly, the collapsor 204 may include a number of protrusions 208 that extend into the orifice 206 and define a number of alignment voids 210 therebetween to facilitate initial alignment of the prosthesis 500 into the orifice 206. Additionally, the handle support 218 of the collapsor system 200 may include a handle support aligner 220. When the handle 308 of the delivery system 300 is placed on the handle support 218, the handle support aligner 220 engages the handle aligner 310 of the handle 308. As a result, the delivery system 300 can be aligned longitudinally and axially in a desired position for folding and loading the prosthesis 500 installed in the orifice 206 .

[0057] FIG. 4G shows a perspective view of the delivery system 300 positioned on the collapsor system 200 after actuation with the actuator 212 to collapse the prosthesis 500. Upon actuation by the user, the size of the orifice 206 is reduced from a first size (shown in FIG. 4F) to a second, smaller size (shown in FIG. 4G) to collapse the prosthesis 500 onto the delivery system 300 while the collapsor 204 is in the second position. The collapsor sector portion 232 is reoriented upon actuation to reduce the size of the orifice 206 from the first size to the second, smaller size. For example, the collapsor sectors 228, 230 may collapse onto each end of the prosthesis 500 while the center of the prosthesis 500 is not in contact with the collapsor sectors 228, 230.

[0058] While the collapsor 204 remains in the collapsed position shown in FIG. 4G, a user may actuate the delivery system 300 to move components at a distal portion of the delivery system toward a delivery state. In some embodiments, actuation of the delivery system 300 causes the proximal and distal components of the delivery system 300 to move toward each other to hold the first and second ends of the prosthesis in the collapsed state.

[0059] For example, a user may actuate actuator 320 (e.g., by rotating knob 322) to move sheath 312 distally and move distal tip proximally, as shown in FIG. 4H. In this manner, sheath 312 may partially hold one end (e.g., the outflow end) of prosthesis 500 in a collapsed position, and distal tip may partially hold the other end (e.g., the inflow end) of prosthesis 500 in a collapsed position. However, in some embodiments, collapsor 204 creates an opening smaller than sheath 312 and distal tip in the collapsed position shown in FIG. 4H, thereby preventing delivery system 300 from transitioning fully to the delivery state by limiting longitudinal movement of sheath 312 relative to collapsor sectors 228, 230. However, the delivery system 300 is further deflected (eg, via a spring such as spring 328 in FIG. 3D) such that the sheath 312 is unable to perform a full stroke because it stops against the collapse sector.

[0060] As described above, the collapsor system 200 may include a mechanism for self-locking the actuator 212 in the collapsed position shown in Figures 4G and 4H, such as a mechanism at the end of the plurality of curved, radially spaced holes in the toroid. In this manner, the user does not need to apply force to the collapsor handle while the collapsor 204 is in the collapsed position, thereby freeing the user's hands to perform other tasks, such as actuating the delivery system to transition the delivery system toward the delivery state.

[0061] FIG. 4I shows a perspective view of the delivery system 300 positioned on the collapsor system 200 after further actuation of the actuator 212 to transition the orifice 206 of the collapsor 204 from the collapsed position to a larger open position. In some embodiments, the user manipulates the actuator 212 to disengage the self-lock holding the actuator 212 in the collapsed position, such as by moving the component past an inflection point and / or disengaging the component. As shown, the prosthesis 500 remains coupled to the distal portion of the delivery system in the collapsed state. In some embodiments, upon further actuation, the collapsor is transitioned from a smaller sized orifice to a larger sized orifice, moving the proximal and distal components of the delivery system closer together to securely hold the prosthesis in the collapsed state for delivery to the patient. Thus, upon further actuation, the components at the distal portion of the delivery system 300 may be fully transitioned to the delivery state. For example, pulling the collapsor handle to open the sectors can allow the delivery system 300 to fully unspring, thereby allowing the sheath and distal tip to fully capture the end of the prosthesis.

[0062] FIG. 4J shows the delivery system 300 with the prosthesis 500 folded and loaded thereon after being removed from the collapsor system 200. The prosthesis 500 may then be delivered in a folded state using the delivery system 300 to a target implantation site (e.g., the location of a defective heart valve that may have been surgically removed). Once at the target implantation site, the prosthesis 500 may transition from the folded state to an expanded state in order to implant the prosthesis 500 at the target implantation site. The distal portion of the delivery system may then be withdrawn from the patient. Further, expansion of the prosthesis 500 may be performed using the balloon catheter 400. In this manner, for example, the prosthesis may be implanted to treat a defective heart valve.

[0063] Although various exemplary embodiments of the present invention have been described above, it will be apparent to those skilled in the art that various changes and modifications may be made herein without departing from the invention. It is intended that the appended claims cover all such changes and modifications that fall within the true scope of the present invention.

Claims

1. 1. A system for folding a prosthesis for delivery to a patient, the system comprising: Base; and a collapsor coupled to the base, the collapsor having an orifice sized and shaped to receive the prosthesis in an expanded state while the collapsor is in a first position relative to the base, the collapsor configured to move from the first position to a second position such that the orifice is oriented in a different direction relative to the base than when the collapsor is in the first position, the collapsor further configured to reduce a size of the orifice from a first size to a second, smaller size while the collapsor is in the second position to collapse the prosthesis onto a delivery system, thereby preparing the prosthesis for delivery in a collapsed state to a patient via the delivery system.

2. 10. The system of claim 1, wherein the collapsor further comprises an actuator configured, upon actuation, to cause the collapsor to reduce the size of the orifice from the first size to the second, smaller size such that the prosthesis is loaded into the delivery system in the collapsed state.

3. 3. The system of claim 2, wherein the actuator is configured to, upon further actuation, cause the collapsor to increase the size of the orifice from the second, smaller size to the first size such that the prosthesis remains collapsed in the delivery system.

4. The system of claim 2 or 3, wherein the actuator comprises a handle.

5. The system of claim 1 , further comprising a movable base coupled to the collapsor and movably coupled to the base.

6. The system of claim 5 , wherein a portion of the base extends below the movable base.

7. 7. The system of claim 1, wherein the collapsor in the first position allows top-loading of a prosthesis in the expanded state into the orifice and in the second position allows side-loading of the delivery system into the orifice.

8. The system of claim 1 , further comprising a lock configured to maintain the collapsor in the first position via an interface with the base.

9. The system of claim 8 , wherein the lock is releasable upon application of a predetermined force toward the second position.

10. 10. The system of claim 9, wherein the lock includes a flexible protrusion extending from the base and engaging a recess in a top of the collapsor housing, the flexible protrusion configured to deflect upon application of the predetermined force to release the recess.

11. The system of claim 1 , further comprising a base lock configured to maintain the collapsor in the second position via an interlock with the base.

12. 12. The system of claim 1, further comprising a handle support configured to support a handle of the delivery system while a distal portion of the delivery system is inserted into the orifice to collapse the prosthesis.

13. 13. The system of claim 12, wherein the handle support includes an alignment mechanism configured to engage a corresponding mechanism on the handle of the delivery system to longitudinally and axially align the delivery system during folding of the prosthesis.

14. a shelf extending upwardly from the base; 14. The system of claim 1, wherein the shelf is configured to contact the collapsor and securely maintain the collapsor in the first position.

15. The system of claim 1 , wherein the first position is substantially orthogonal to the second position.

16. 16. The system of claim 1, wherein the collapsor includes a housing configured to accommodate a first collapsor sector and a second collapsor sector, each having a plurality of collapsor sector portions, the plurality of collapsor sector portions configured to move upon actuation to reduce the size of the orifice from the first size to the second smaller size.

17. 17. The system of claim 16, wherein the collapsor includes a first annular body and a second annular body configured for relative rotation about an axis, the first annular body and the second annular body each further including a plurality of radially spaced curvilinear holes for receiving components of the first collapsor sector and the second collapsor sector, respectively.

18. 20. The system of claim 17, wherein the plurality of radially spaced curvilinear holes of the first and second annular bodies are configured to self-lock when the first and second collapsing sectors are in a position corresponding to the second, smaller size.

19. 19. The system of claim 17 or 18, wherein a handle is coupled to the first annular body and the second annular body.

20. 20. The system of claim 17, wherein the collapsor further comprises a collapsor center frame configured to be positioned in the housing between the first annular body and the second annular body.

21. 21. The system of claim 1, wherein the collapsor further comprises a plurality of protrusions extending into the orifice and defining spaces therebetween to facilitate alignment of the prosthesis within the orifice.

22. 22. The system of any one of claims 1-21, wherein in the second, smaller size, the collapsor prevents components at a distal portion of the delivery system from transitioning completely to a delivery state.

23. 23. The system of claim 1, further comprising the supply system.

24. 24. The system of any one of claims 1 to 23, further comprising a balloon catheter configured to expand the prosthesis after deployment from the delivery system.

25. 25. The system of claim 1, further comprising the prosthesis, the prosthesis comprising a prosthetic heart valve.

26. 1. A method for folding a prosthesis for delivery to a patient, comprising: loading a prosthesis into an orifice of the collapsor while the collapsor is in a first position relative to the base; moving the collapsor from the first position to a second position while leaving the base in place; inserting a distal portion of a delivery system into the prosthesis loaded within the orifice while the collapsor is in the second position; and folding the prosthesis onto the distal portion of the delivery system via the collapsor to prepare the prosthesis for delivery to a patient in a folded state via the delivery system. A method comprising:

27. after folding the prosthesis, actuating the delivery system to move proximal and distal components of the delivery system toward one another to hold the proximal and distal ends of the prosthesis in the folded condition; and transitioning the collapsor from a smaller sized orifice to a larger sized orifice such that the prosthesis remains coupled to the distal portion of the delivery system in the collapsed state.

27. The method of claim 26, further comprising:

28. 28. The method of claim 27, wherein the step of transitioning the collapsor from the smaller sized orifice to the larger sized orifice causes the proximal and distal components of the delivery system to move closer toward one another to securely hold the prosthesis in the collapsed state for delivery to the patient.

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