Lock and release mechanism for a transcatheter implantable device

Abstract

A delivery system and catheter including a lock and release connector for an implantable device, and a method for holding, positioning, and deploying a medical device are disclosed. The lock and release connector may include a body and at least one door engaged with the body, the door being movable from a first position to a second position. The lock and release connector may further include at least one fastener connecting at least one end of the door to the body. The door may be integral with or connected to the body and may include a shape memory material and / or other material.

Description

Technical Field

[0001] Cross-reference This application claims the benefit of U.S. Provisional Patent Application No. 62 / 527,577, filed Jun. 30, 2017, and U.S. Patent Application No. 15 / 422,354, filed Feb. 1, 2017, which claims the benefit of U.S. Provisional Patent Application No. 62 / 292,142, filed Feb. 5, 2016, the entire disclosures of which are incorporated herein by reference in their entirety as if fully set forth herein.

[0002] The present invention relates to a delivery system for an implantable device, which includes a lock and release mechanism for an implantable medical device that can be used with a transcatheter delivery system for use in conduits, vessels, lumens, passages, or cavities of an anatomical structure including the heart and vasculature. Transcatheter implantable devices include docking stations, heart valve implants such as replacement valves, and transcatheter heart valves (“THVs”), stents, artificial valve rings, and other annuloplasty implants.

Background Art

[0003] Implantable medical devices can be used in many different parts of the body for a variety of applications, including orthopedics, pacemakers, cardiovascular stents, defibrillators, or neural prosthetics. Transcatheter technology can be used to introduce and implant an artificial heart valve or other medical device using a flexible catheter in a less invasive manner than open-heart surgery or other conventional surgeries. In this technique, the medical device is mounted in a crimped state on the distal end portion of the flexible catheter and can be advanced through blood vessels, ducts, or other body passages until the device reaches the implantation site. Next, the catheter tip of the device can be expanded to its functional size at the intended implantation site, such as by inflating a balloon on which the device is mounted. Optionally, the device can have an elastic, self-expanding stent or frame that expands the device to its functional size when advanced from a delivery sheath at the distal end of the catheter. The implantable medical device is maintained within the catheter until it is deployed and expanded within the patient.

Summary of the Invention

Problems to be Solved by the Invention

[0004] This summary is provided for the purpose of providing examples and is in no way intended to limit the scope of the present invention. For example, any feature included in the examples of this summary is not essential to the claims unless the claims expressly list that feature. The description discloses exemplary embodiments of locks and release connectors for transcatheter implantable devices and catheters for the implantation of medical devices. The locks and release connectors and the catheters can be constructed in a variety of ways.

Means for Solving the Problems

[0005] In an exemplary embodiment, a lock and release connector for a transcatheter implantable device may include a body and at least one door engageable with the body, the door being movable from a first position to a second position. Optionally, the door may be integral with the body. In some exemplary embodiments, the door may be connected to the body. Optionally, the door may be hingedly connected to the body. The door may be constructed in various ways and may include various different materials, for example, the door may include a nickel-titanium alloy. The lock and release connector may further include one or a plurality of fasteners that connect at least one portion or end of the door to the body.

[0006] In an exemplary embodiment, a system and / or catheter includes an outer tube having a distal opening. An inner tube may be disposed within the outer tube. An implantable medical device is disposed within the outer tube, and the medical device has an extension. The lock and release connector has a body and a door engaged with the body. The door is movable from a first position to a second position. When an inner tube is used, the lock and release connector may be connected to the inner tube. The extension may be disposed between the body and the door. Optionally, the implantable medical device may further include at least a second extension. In some exemplary embodiments, the lock and release connector further includes a second door. Optionally, the implantable medical device may be a docking station. The body may be hingedly connected to the door.

[0007] In an exemplary embodiment, a method of positioning a medical device includes connecting a lock and release connector to an inner tube of a catheter. The method may further include installing the inner tube inside an outer tube of the catheter. Further, an extension may be placed between a body and a door of the lock and release connector connected to the inner tube at a proximal end of the medical device. The method may further include positioning the medical device within the outer tube of the catheter and positioning a distal end of the catheter at a delivery site. Further, the outer tube may be displaced relative to, or with respect to, the inner tube and the lock and release connector until a distal end of the medical device is positioned outside the outer tube. The method may further include continuing to displace the outer tube relative to, or with respect to, the inner tube and the lock and release connector until the door opens and releases the extension from between the body and the door. Further, the proximal end of the medical device, and the extension, may be deployed to the delivery site. In some exemplary embodiments, the method further includes returning the lock and release connector to a position inside the outer tube.

[0008] Various features as described in other parts of this disclosure may be included in the embodiments summarized herein, and various methods and steps for using those embodiments and features may be used, including those as described in other parts of this disclosure, in various combinations.

[0009] A further understanding of the nature and advantages of the disclosed invention can be obtained from the following description and the claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.

[0010] To further clarify various aspects of the embodiments of the present disclosure, a more specific description of certain embodiments is provided by referring to various aspects of the accompanying drawings. These drawings depict only typical embodiments of the present disclosure and are therefore not considered to limit the scope of the disclosure. Further, although the drawings may be drawn to scale in some embodiments, they are not necessarily drawn to scale in all embodiments. Embodiments of the present disclosure are described and explained more specifically and in detail through the use of the accompanying drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0012] In the following description, reference is made to the accompanying drawings, which show certain embodiments of the invention. Other embodiments having different structures and operations are not outside the scope of the invention. Exemplary embodiments of the present disclosure are directed to a lock and release connector (e.g., referring to the lock and release connector 7000 of FIGS. 15A and 15B) for an implantable medical device 10 (e.g., for a transcatheter implantable device), as well as catheters, systems, and assemblies for medical device implantation. In some exemplary embodiments, the medical device 10 is shown as a docking station, e.g., a docking station for a THV used inside the pulmonary artery. However, the lock and release connectors described and shown herein can be used in other areas of anatomical structures for various medical devices, including many other conduits, lumens, vasculature, passages, or cavities of anatomical structures, including those for orthopedics, pacemakers, cardiovascular stents, grafts, coils, defibrillators, for neuroprosthetics, and also those within the heart and vascular structures. The use of the lock and release connectors and the inventive concepts disclosed herein are limited only by the creativity of the designer.

[0013] FIGS. 1A - 12D show the human heart and illustrate examples of medical devices in which the lock and release mechanism 7000 can be used together, and these figures will be described in more detail later in the present disclosure. The implantable medical devices shown in FIGS. 2A - 12D are merely examples of many types of medical devices in which the lock and release connector 7000 can be used together. FIGS. 1A - 12D are obtained from co-pending U.S. Patent Application No. 15 / 422,354, which is hereby incorporated by reference in its entirety. FIGS. 1A - 14C will be described in more detail below to provide examples of the application of the lock and release mechanism and related concepts.

[0014] Lock and release connectors (see, e.g., the lock and release connector 7000 of FIGS. 15A and 15B), medical devices, and various embodiments of anchors / extensions on medical devices are disclosed herein, and it should be noted that any combination of the various features and options described or shown herein may be made, unless specifically excluded. For example, even if a particular combination is not explicitly described, any of the disclosed lock and release connectors may be used with any type of medical device, valve, and / or any delivery system. Similarly, even if the various configurations of the lock and release connectors and medical devices are not explicitly disclosed, they may be mixed and adapted, such as by combining any type / feature of lock and release connector, type / feature of medical device, etc. Briefly, the individual components of the disclosed systems may be combined, unless they are mutually exclusive or otherwise physically impossible.

[0015] For consistency, in these figures and others herein, medical devices such as docking stations are depicted with the pulmonary bifurcation end up and the ventricular end down. These directions may also be referred to as "distal" as a synonym for far, up, and / or the pulmonary bifurcation end, and "proximal" as a synonym for near, down, and / or the ventricular end, and these are terms relative to the perspective of the physician.

[0016] Figures 11A, 11B, and 12A - 12D show the distal portion of an exemplary embodiment of a catheter 3600 for delivering and deploying an implantable medical device 10. In the exemplary embodiment, the medical device 10 is described and discussed herein as a docking station, but the frame / covering frame may also represent a stent, a stent frame, a stent - graft, a frame including a valve (e.g., representing a trans - catheter heart valve THV), and other medical devices. The catheter 3600 can take a wide variety of different forms. In the illustrated example, the catheter 3600 includes an outer tube / sleeve 4910, an inner tube / sleeve 4912, a connector 4914 connected to the inner tube 4912, and an elongate nose cone 28 connected to the connector 4914 by a connecting tube 4916. In some embodiments, the connector 4914 is a lock and release connector 7000 (see, e.g., FIGS. 15A and 15B). The implantable medical device 10 is described / discussed as a docking station, but any medical device can be used. The inner tube 4912 can be disposed within the outer tube 4910.

[0017] The implantable medical device 10 can be disposed within the outer tube 4910 (see FIG. 11B). An extension 5000 can connect the medical device 10 to the connector 4914, which can be the lock and release connector 7000 described herein or a connector incorporating the inventive concepts described herein. The extension 5000 can be a holding portion, which can be longer than the remainder of the holding portion 414 (see FIGS. 12C - 12D). The catheter 3600 includes a guidewire lumen 6390 and can be sent over a guidewire 5002 to position the medical device 10 at the delivery site.

[0018] Referring to FIGS. 12A - 12D, when the medical device 10 is a docking station or includes an expandable frame, the outer tube 4910 can be gradually retracted relative to the medical device 10, the inner tube 4912, the connector 4914 (which can be either the lock and release connector 7000 described herein or a connector incorporating the inventive concept herein), and the elongated nose cone 28 to deploy the medical device 10. It is preferred to retract the outer tube relative to the medical device, inner tube, nose cone, connector, etc. (as depicted in FIGS. 12A - 12D) (i.e., these remain stationary, e.g., stationary relative to the proximal handle), but it is also possible to advance the medical device, inner tube, nose cone, and / or connector relative to the outer sheath. In FIG. 12A, the medical device 10 begins to expand from the outer tube 4910. In FIG. 12B, the distal end 14 of the medical device 10 expands from the outer tube 4910. In FIG. 12C, the medical device 10 expands from the outer tube 4910 except that the extension 5000 remains held by the connector 4914, e.g., the lock and release connector 7000 within the outer tube 4910. In FIG. 12D, the connector 4914, e.g., the lock and release connector 7000, extends from the outer tube 4910 to release the extension 5000, thereby expanding the frame and fully deploying the medical device. Similar steps can be used while deploying the medical device within the circulatory system, and the medical device can be deployed similarly.

[0019] Figures 13, 14A, 14B, and 14C show a non-limiting example of a method by which the medical device 10 can be coupled to the connector 4914, particularly the lock and release connector 7000. As shown by FIGS. 12A-12D, when the medical device 10 is pushed out of the outer tube 4910, the medical device self-expands in one exemplary embodiment. One approach to controlling the expansion of the medical device 10 is to secure at least one end of the stent, e.g., the proximal end 12, to the connector 4914, e.g., the lock and release connector 7000. This approach first expands the distal end 14 of the stent without expanding the proximal end (see FIG. 12B). Next, when the outer tube / sheath 4910 is moved rearward or retracted relative to the device 10 (or the stent is moved forward relative to the outer tube 4910), the proximal end 12 is disengaged from the connector 4914, e.g., the lock and release connector 7000, and the proximal end 12 of the medical device can expand (see FIG. 12D).

[0020] This can be facilitated by including one or more anchors or extensions 5000 on at least the proximal end of the device 10. In the illustrated embodiment, one or two extensions are included. However, any number of extensions 5000, such as one, two, three, four, five, etc., can be included. The extensions 5000 and / or the heads 5636 of the extensions can adopt a wide variety of different forms, shapes, sizes, etc. The extension 5000 can engage a connector 4914, such as a lock and release connector 7000, inside the outer tube 4910. The extension 5000 can include a face 5600 and can include a head 5636 with side faces 5640 that extend away from the straight portion 5638 at an angle β (see FIG. 14B), such as an angle between 30° and 60°. Such a head 5636 can generally be triangular as shown, or another shape (e.g., round, spherical, rectangular, pyramidal, etc.), and for example, the angled side faces 5640 can be connected to each other by another shape, such as a rounded shape, a rectangular shape, a pyramidal shape, or another shape. That is, the head 5636 can function in the same way as the shown triangular head even if it is not triangular.

[0021] Referring to FIGS. 14A and 14B, a head 5636 having side surfaces 5640 extending away from each other at an angle β, such as a triangular head. Referring to FIGS. 13, 14A, 14B, and 14C, the head 5636 fits within a T-shaped recess 5710 of the holder to hold the proximal end 12 of the medical device while the distal end self-expands inside the body. The connector 4914, or specifically the lock and release connector 7000, remains within the delivery catheter until it is relatively moved from the catheter (e.g., by retracting the outer tube / sleeve 4910 or advancing the connector 4914: see FIG. 12D). Referring to FIG. 13, the outer tube / sleeve 4910 of the catheter 3600 can be disposed adjacent to the connector 4914, whereby the head 5636 is captured within the recess 5710 (or between the recess 5710 and the door 7020 of the lock and release assembly: see FIG. 22) between the outer tube / sleeve 4910 and the body of the connector 4914. This capture within the recess 5710 holds the end of the medical device 10 when the medical device expands. Thus, the delivery of the medical device 10 is controlled and recapture of the at least partially deployed device is possible (e.g., FIGS. 12A and 12B show an example of a partially deployed device that can be recaptured).

[0022] Referring again to FIG. 12D, at the end of the expansion of the medical device 10, if the distal end of the medical device is already expanded, the connector 4914 or the lock and release connector 7000 moves relatively from the outer sleeve. The head 5636 then freely moves radially outward and disengages from the respective recess 5710 (see FIG. 13) or recess 5710 and door 7020 (see FIG. 24B). The head 5636 can open the door 7020 and / or the door can be opened in other ways as described below. Although referred to herein as a "door", the feature 7020 can be called a latch, lock, arm, hinge portion, or other descriptor.

[0023] In one embodiment, all of the extension portions 5000 are of the same length. When the connector is moved relative to the outer tube / sleeve 4910, the recess 5710 is simultaneously moved relative to the outer sleeve 4910. Since all of the extension portions 5000 are of the same length, the recesses 5710 all appear simultaneously from the outer sleeve 4910 together with the head 5636. Accordingly, the head 5636 and / or the door 7020 of the docking station move radially outward and are released all at once.

[0024] FIG. 15A is a perspective view of one embodiment of a lock and release connector 7000 for a transcatheter implantable device 10. The lock and release connector 7000 can be used to deploy a medical device 10 as shown in FIGS. 12A-12D. In an exemplary embodiment, the lock and release connector 7000 for the transcatheter implantable device 10 includes a body 7010 and at least one door 7020 engaged with the body 7010, and the door 7020 is movable from a first position to a second position. In some exemplary embodiments, the first position may be a closed position, including but not limited to a partially closed position. In other exemplary embodiments, the second position may be an open position, including but not limited to a partially open position. In some exemplary embodiments, the door 7020 may be integral with the body 7010 (not shown). In some exemplary embodiments, the door 7020 can be connected to the body 7010. The lock and release connector 7000 may include a body 7010 and at least one door 7020 hingedly connected to the body 7010. In the illustrated embodiment, the lock and release connector has two doors 7020. However, the lock and release connector 7000 can have any number of doors, including but not limited to one, two, one to two, two to five, three to four, one to six doors, or any other number of doors. Each door can be configured to grip / lock / hold a single extension 5000, or one or more doors (e.g., one or more doors 7020) can be configured to grip / lock / maintain a plurality of extensions. FIG. 15A shows an exemplary embodiment of the lock and release connector 7000 with the door 7020 closed and / or in the first position. FIG. 15B shows a perspective view of the lock and release connector 7000 with the door 7020 open and / or in the second position. FIG. 16 is an exploded view of the lock and release connector 7000. In some embodiments, the lock and release connector 7000 may further include at least one fastener 7040 that connects at least one end of the door 7020 to the body 7010. The body 7010 and the door 7020 can be hingedly connected by the fastener 7040.In some embodiments, the fastener 7040 may be a hinge pin. The fastener 7040 may be a wire, screw, hinge, suture, string, latch, pin, or the like. The body 7010 and the door 7020 may be hingedly connected by any fastener known in the art.

[0025] In some exemplary embodiments, the door 7020 is moved passively from a closed position to an open position. That is, in some embodiments, the lock and release connector 7000 does not include any mechanism for moving the door 7020 from a closed position to an open position or from an open position to a closed position. For example, the door 7020 may be opened by an external force, such as the force of expansion of a stent, docking station, or other medical device 10, when the device is deployed / released from the catheter.

[0026] In another exemplary embodiment, the door 7020 of the lock and release connector 7000 may optionally utilize a mechanism that translates the door 7020 from a first position to a second position, including from a closed state to an open state and from an open state to a closed state. In some exemplary embodiments, the door may be actively controlled to move from a first position to a second position. For example, the lock and release connector 7000 may further include at least one spring 7050 (or similar mechanism) that exerts a force on the door 7020 to bias the door open. In other embodiments, the door 7020 can be controlled by a control wire to translate the door 7020 from a first position to a second position, including from a closed state to an open state and from an open state to a closed state. In some exemplary embodiments, the door 7020 may be made of a shape memory or pseudoelastic material such as a shape memory alloy, including but not limited to copper-aluminum-nickel alloys and nickel-titanium alloys, an example of which is nitinol. With these shape memory materials, the door 7020 is pressed into a closed state, including but not limited to a partially closed position, to engage the body 7010, and then, when the compressive force is released (e.g., when deployed from a catheter), the door 7020 self-expands to return to its open state prior to the compression. In this embodiment, the shown fastener 7040 may be omitted. For example, the body 7010 and the door 7020 may be integrally formed or fixed to each other, and the door 7020 may bend from a first position to a second position, including from a closed position to an open position.

[0027] Figures 17A - 17B show a partial view of a catheter 3600 having an outer tube 4910 with a distal opening 7060. In the illustrated embodiment, the connector 4914 is specifically a lock and release connector 7000 having a body 7010 and a door 7020 connected to the body 7010. The lock and release connector 7000 can be used to hold the implantable medical device 10 within the delivery catheter 3600 until the medical device is moved relatively from the catheter 3600 or the outer tube / sleeve / sheath 4910 (e.g., by retracting the outer tube / sleeve / sheath 4910 or by advancing the lock and release connector 7000).

[0028] In some exemplary embodiments, the lock and release connector 7000 is connected to the inner tube 4912 in the same manner as to the connector 4914 (see FIG. 11B). FIGS. 18A - 21B show one way in which one or more extensions 5000 of the implantable medical device 10 are disposed between the body 7010 and the door 7020 of the lock and release connector 7000. Referring to FIG. 18A, the outer tube 4910 is gradually retracted relative to the lock and release connector 7000, whereby the door 7020 reaches the open position. Alternatively, the lock and release connector 7000 can be gradually advanced relative to the outer tube 4910 to open the door 7020 and / or reach a second position.

[0029] The door 7020 is passive and can be opened by the extension 5000 of the medical device or can be opened and / or reach a second position using various active mechanisms. In a passive embodiment, the door is opened or translated to the second position by the release of potential energy stored in the implantable device or the "stent" itself when the outer tube 4910 is retracted.

[0030] In some embodiments, the stationary state of door 7020 is open and / or in a second position, such that door 7020 is passively repositioned when outer tube 4910 is retracted. In some embodiments, door 7020 opens or translates to the second position by releasing the potential energy stored in spring 7050 disposed between door 7020 and body 7010 (shown schematically in FIG. 27). In some embodiments, door 7020 is controlled by a control wire or guide wire 5002 to translate door 7020 from a first position to a second position, including from a closed state to an open state and from an open state to a closed state. In some embodiments, door 7020 is composed of a shape memory material such as a nickel-titanium alloy like nitinol. With these shape memory materials, door 7020 is compressed into a closed state when confined inside outer tube 4910, and then, when the compressive force is released, door 7020 self-expands to return to its open state prior to compression. In this embodiment, the shown movable connection between door 7020 and body 7010 may be omitted. The door is fixedly attached to the body and can bend from a closed position to an open position.

[0031] As shown in FIGS. 18B - 20B, to connect the implantable medical device 10 (see, e.g., FIGS. 9 and 11B) to the lock and release connector 7000, the extension 5000 is placed between the body 7010 and the door 7020 of the lock and release connector 7000. As shown in FIG. 18B, the extension 5000 is brought into proximity with the lock and release mechanism 7000. In FIG. 19A, the extensions 5000 are being compressed towards each other. In FIG. 19B, the extensions 5000 are being moved into the space between the door 7020 and the body 7010. FIG. 20A shows the extension 5000 installed in the cutout or recess 5710 within the body 7010. FIG. 20B shows the door 7020 closed to connect the implantable medical device to the lock and release connector. The door 7020 can be closed as shown in FIG. 20 when the door is controlled by a control wire (not shown) that is connected to the door and extends through the catheter 3600 to the proximal end of the catheter. However, the door 7020 can be closed simply by advancing the outer tube / sleeve / sheath 4910 over the lock and release connector 7000, or by retracting the lock and release device 7000 into the outer tube 4910 of the catheter. That is, the distal opening 7060 or the outer surface of the outer tube 4910 engages the door 7020 to close the door when the lock and release device is covered by the tube 4910.

[0032] As shown in FIGS. 21A-21B, once the extension part is installed, until each door 7020 closes to lock each extension part 5000 in a predetermined position within the cutout part or recess 5710, the outer tube 4910 is advanced (or the lock and release device 7000 is retracted) to cover the lock and release connector 7000. FIGS. 22-23 are cutaway views showing the lock and release connector 7000 inside the outer tube 4910 with the door 7020 in the closed and / or first position where the extension part is locked in a predetermined position. The head 5636 of each extension part 5000 fits into the T-shaped recess 5710 within the lock and release device 7000 and holds the proximal end portion 12 of the medical device 10. When the outer tube / sleeve 4910 of the catheter 3600 is disposed in proximity over the lock and release connector 7000, the head 5636 is captured between the body 7010 and the door 7020 within the recess 5710. By this capture within the recess 5710, the end portion of the medical device 10 is held when the medical device expands. In this way, the delivery of the medical device 10 is controlled. When the device 10 is partially deployed, the device 10 can also be recaptured by advancing the outer tube / sheath over the device 10 again or by retracting the device 10 into the outer tube / sheath.

[0033] Figures 24A - 25B show exemplary embodiments of the release of the extension 5000 of the implantable medical device 10 from between the body 7010 of the lock and release connector 7000 and the door 7020. Referring to FIGS. 24A - 24B, the outer tube 4910 is gradually retracted relative to the lock and release connector 7000, whereby the door 7020 opens and / or reaches a second position. Optionally, the lock and release connector 7000 can be gradually advanced relative to the outer tube 4910 to open the door 7020 and / or cause it to reach a second position, or the lock and release connector 7000 can be advanced simultaneously with the retraction of the outer tube / sheath. Once the door 7020 opens, the extension 5000 is released. For example, the potential energy stored in the extension 5000 can be used to open the door 7020 and expand the extension outward from the door. Referring to FIGS. 25A - 25B, when the outer tube 4910 advances over the lock and release connector 7000, the door 7020 is pushed closed and / or to a first position by the outer tube 4910.

[0034] Figures 26A - 26B show another embodiment of the lock and release connector 7000 in which the door 7020 is simplified and minimized. In this example, the door 7020 has a small, simple rectangular shape. However, the door 7020 can have any shape including, but not limited to, a T - shape, a triangle, an octagon, a square, a cylinder, or any other shape adapted to hold the extension 5000 within the lock and release connector 7000.

[0035] The lock and release connector 7000 can be configured to retract or withdraw the medical device into the catheter assembly after partial deployment, e.g., when the outer tube 4910 exposes a portion of the medical device but the lock and release connector 7000 is advanced far enough to prevent the release of the extension 5000. For example, 30% to 90% (or any range within 30% to 90%, including but not limited to 20% to 80%, 30% to 60%, 40% to 90%, 60% to 40%, 50% to 80%, etc.) of the length of the implantable medical device 10 can be exposed from the outer tube 4910 while the door 7020 still holds the implantable medical device 10 and allows the implantable medical device 10 to be retracted back into the tube 4910. If the lock and release connector 7000 cannot release the extension 5000, the implantable medical device 10 is withdrawn back into the catheter to reposition the catheter prior to redeployment of the medical device, thus allowing the medical device to be retrieved and repositioned after partial deployment.

[0036] As described above, the lock and release connector 7000 can be used to controllably deploy a wide variety of different medical devices in a wide variety of different applications. The human heart H is one of many locations where the lock and release connector 7000 can be used. The lock and release connector 7000 can be used to deploy a wide variety of different devices into the heart. Some details of the human heart and a docking station for providing a landing zone are described below to provide an example of one of many applications where the connector 7000 can be used.

[0037] Referring again to FIGS. 1A and 1B, the human heart H is shown in diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA, respectively, by the tricuspid valve TV and the mitral valve MV, i.e., the atrioventricular valves. Further, the aortic valve AV separates the left ventricle LV from the (not identified) ascending aorta, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has a flexible valve leaflet that extends inwardly across each orifice where the flowstream converges or "joins" to form a one-way fluid occluding surface.

[0038] The right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC and the inferior vena cava IVC. The superior vena cava SVC enters the right atrium from above, and the inferior vena cava IVC enters the right atrium from below. The coronary sinus CS is a group of veins that converge to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium) and delivers it to the right atrium RA. During diastole, or heart relaxation, as seen in FIG. 1A, the venous blood that collects in the right atrium RA passes through the tricuspid valve TV when the right ventricle RV expands. During systole, or heart contraction, as seen in FIG. 1B, the right ventricle RV contracts and pumps the venous blood into the lungs through the pulmonary valve PV and the pulmonary artery. During heart contraction, the valve leaflets of the tricuspid valve TV close to prevent the backflow of venous blood into the right atrium RA.

[0039] As described above, the lock and release connectors can be used to hold and release a wide variety of implantable medical devices. Referring to FIGS. 2A-2B, in an exemplary embodiment, the implantable medical device 10 is depicted as an expandable docking station that includes one or more seal portions 410, a valve seat 18, and one or more retention portions 414. The seal portion 410 provides a seal between the medical device 10 and the inner surface 416 of the circulatory system. The valve seat 18 provides a support surface that can be used to attach a valve to the device 10 or to implant or deploy a valve (e.g., a THV) into the device 10 (configured as a docking station) after the device / docking station has been implanted in the circulatory system. The retention portion 414 can assist in holding the medical device 10 (e.g., the docking station) and the valve in an implanted position or deployment site within the circulatory system. The expandable docking station, as described or illustrated in various embodiments herein, also represents various docking stations, valves, and / or other medical devices 10 that are known or may be developed.

[0040] FIGS. 2A-2B schematically illustrate an exemplary deployment of the medical device 10. In some exemplary embodiments, the medical device is in a compressed form / configuration and is introduced into a deployment site within the circulatory system. For example, the medical device 10 can be positioned at a deployment site within the pulmonary artery by a catheter (e.g., catheter 3600 as shown in FIGS. 12A-12D). Referring to FIG. 2B, the medical device 10 is expanded within the circulatory system such that the seal portion 410 and the retention portion 414 engage the inner surface 416 of a portion of the circulatory system.

[0041] The medical device can be made from highly flexible metals, metal alloys, or polymers. Examples of metals and metal alloys that can be used include, but are not limited to, Nitinol, Elgiloy, and stainless steel, and other metals and highly elastic or flexible non-metallic materials can be used. For example, the medical device 10 can have a frame or a part of the frame (e.g., a self-expanding frame, a retaining portion, a sealing portion, a valve seat, etc.) made of these materials, such as a shape memory material like Nitinol. With these materials, the frame is compressed to a small size, and then, when the compressive force is released, the frame self-expands and returns to its diameter before compression.

[0042] Referring to FIG. 3, the medical device 10 is illustrated and is held in the pulmonary artery PA, for example, by radially expanding one or more of the retaining portions 414 into the region of the pulmonary artery PA. For example, the retaining portion 414 can be configured to extend radially outward into the lung bifurcation 210 and / or the opening 212 of the pulmonary artery into the right ventricle.

[0043] FIGS. 4 - 8 show exemplary embodiments of the frame 1500 or body of an implantable medical device 10 (e.g., a docking station, a stent, a stent-graft, a THV, etc.). The frame 1500 or body can take a wide variety of different forms, and FIGS. 4, 5, 6, 7, and 8 show only one of many possible configurations. The device 10 has a relatively wide proximal inflow end 12 and a distal outflow end 14, and a relatively narrow portion 16 that forms a seat 18 (e.g., that can be used to mount / attach or dock a valve internally) between the ends 12, 14. In the embodiments shown by FIGS. 4, 5, 7, and 8, the frame 1500 of the device 10 is depicted as a stent composed of a plurality of metal struts 1502 that form cells 1504. In the embodiments of FIGS. 4, 5, and 7 - 10, the frame 1500 has a generally hourglass shape with a narrow portion 16 that forms the valve seat 18 and is covered by an outer sheath / material 21 between the proximal end 12 and the distal end 14.

[0044] Figures 4, 5, 7, and 8 show the frame 1500 in an unconstrained, expanded state / configuration. In this exemplary embodiment, the retention portion 414 includes the ends 1510 of the metal struts 1502 at the proximal end 12 and the distal end 14. The seal portion 410 is shown between the retention portion 414 and the constriction 16. In the unconstrained state, the retention portion 414 generally extends radially outward and is radially outside of the seal portion 410. FIG. 6 shows the frame 1500 in a compressed state for delivery and expansion by a catheter. The device 10 can be made of a very elastic or flexible material to accommodate large variations in anatomical structures. For example, the docking station can be made of highly flexible metals, metal alloys, and / or polymers. An example of a highly elastic metal is nitinol, although other metals and highly elastic or flexible non-metallic materials can be used. The device 10 can be self-expandable, manually expandable (e.g., expandable using a balloon), mechanically expandable, or a combination thereof.

[0045] Figures 9, 9A, and 9B show the frame 1500 with a sheath / material 21 (e.g., an impermeable or semi-permeable material) attached to the frame 1500. The band 20 can extend around the constriction or narrow portion 16 or can be integral with the constriction to form a non-expandable or substantially non-expandable valve seat 18. The band 20 can harden the constriction and can make the constriction / valve seat non-expandable or relatively non-expandable in the deployed configuration once deployed as the docking station is deployed and expanded.

[0046] FIG. 10 shows the implantable device 10 of FIG. 9 after being implanted into the cardiovascular system (e.g., pulmonary artery, IVC, SVC, aorta, etc.) using a connector 4914, such as a lock and release connector 7000. The seal portion 410 provides a seal between the device 10 and the internal surface 416 within the cardiovascular system. The seal portion 410 may include the outer sheath / material 21 and a rounded, radially outwardly extending portion 2000 below the frame 1500, and may form an impermeable or substantially impermeable portion 1404. In one embodiment, this directs blood flow towards the valve seat 18 (and the valve once installed or deployed in the valve seat). In one embodiment, blood can flow between the device 10 and the surface 416, i.e., in and out of the region 2100, until it reaches the seal portion 410. With the optional permeable portion 1400, blood can flow in and out of the region 2130 as indicated by the arrow 2132.

[0047] Referring to FIGS. 9, 9A, and 9B, the frame 1500 may include one or more of various extensions 5000. As described, the frame 1500 may include one or more extensions 5000, which may be longer than the remainder of the holding portion 414 and may be held by the connector 4914. For example, this may be a lock and release connector 7000 within the outer tube 4910. The extension 5000 is designed such that at least one extension 5000 (e.g., the entire extension or a portion of the extension, such as the head 5636) can be held by the connector 4914. In one embodiment, the extension (e.g., the entire extension or a portion thereof) is releasably held between the T-shaped recess 5710 and the door 7020 of the lock and release connector 7000. The extension 5000 maintains or otherwise controls the position of the frame 1500 after all or substantially all (e.g., 90% or more) of the frame 1500 has been moved distally beyond the distal opening 7060 of the outer tube 4910 and / or after the frame 1500 has expanded substantially or fully radially outward.

[0048] As shown in FIG. 9, the frame 1500 may include two extensions 5000 extending from one end of the frame 1500, for example, the proximal end 12. The extensions 5000 may be of substantially the same length, whereby the head 5636 of each extension 5000 is at substantially the same distance from the remainder of the frame 1500. In such a configuration, the extensions 5000 may be released from the connector 4914, for example, the lock and release connector 7000, substantially simultaneously, as described below. The extensions 5000 may be radially spaced around the proximal end 12 of the frame 1500 in any configuration. In the illustrated embodiment, the extensions 5000 are disposed substantially on both sides of the frame 1500. However, the extensions 5000 may be arranged in other configurations. For example, there may be any number of equally spaced extensions, any number of unequally spaced extensions, and / or the extensions 5000 may extend from adjacent struts 1502.

[0049] As shown in FIG. 9A, the frame 1500 may include one or more first extensions 5000a and one or more second extensions 5000b that extend from one end of the frame 1500, such as the proximal end 12. The first extension 5000a and the second extension 5000b may be longer than the remaining portion of the optional additional holding portion 414 and may be held by a connector 4914, such as a lock and release connector 7000 within an outer tube 4910. The first extension 5000a and the second extension 5000b may be substantially similar to the extension 5000 of FIG. 9, however, the lengths of the first extension 5000a and the second extension 5000b may be different from each other. For example, the second extension 5000b may be longer than the first extension 5000a. The first extension 5000a may be the same length as the extension 5000 of FIG. 9. However, the first extension 5000a may be shorter or longer than the extension 5000 of FIG. 9. In such a configuration, the first extension 5000a may be released from the connector 4914, such as the lock and release connector 7000, while the second extension 5000b remains held by the connector 4914, as will be described in detail below. The first extension 5000a and the second extension 5000b may be distally spaced around the proximal end 12 of the frame 1500 in any configuration. In the illustrated embodiment, the first extension 5000a and the second extension 5000b are disposed substantially on opposite sides of the frame 1500. However, the first extension 5000a and the second extension 5000b may be arranged in other configurations. For example, there may be one, two, three, four, five, or any number of first extensions 5000a and one second extension 5000b. For example, there may be any number of equally spaced extensions 5000a, any number of unequally spaced extensions 5000b, and / or the extensions 5000a and / or 5000b may extend from adjacent struts 1502. The various extensions may be radially spaced around the perimeter of the frame in various configurations.

[0050] As shown in FIG. 9B, the frame 1500 may include a single extension 5000 extending from one end of the frame 1500, for example, the proximal end 12. The extension 5000 may be of any size and may extend proximally beyond the remainder of the frame 1500 and may be held by a connector 4914, for example, a lock and release connector 7000 within the outer tube 4910. The extension 5000 may be substantially similar to the extension 5000 of FIG. 9.

[0051] Although the frame 1500 has been described as having one or two extensions 5000, any number of extensions 5000 may be included. For example, the frame 1500 may include one, two, one to two, two to five, three to four, one to six extensions, or any other number of extensions, without limitation.

[0052] FIGS. 28A and 28B show some examples of extensions that may be used. One or more extensions 5000, or one or more first extensions 5000a or second extensions 5000b, may take various forms. For example, as shown in FIG. 28A, the extension 5000 may be spring-like (other spring-like configurations are possible, for example, coiled). By including a spring-like second extension 5000, the frame 1500 can smoothly extend from the outer tube 4910 when the frame 1500 expands radially when moving distally from the distal opening 7060 of the outer tube 4910. As shown in FIG. 28B, the second extension 5000 may be rod-like and may be stiffer than the extension of FIG. 28A. By including a rod-like extension 5000, the frame 1500 can be positioned or otherwise moved when the frame 1500 expands radially when moving distally from the outer tube 4910. However, one or more second extensions 5000 may take other forms. For example, the extension 5000 may be curved, twisted, bent, coiled, or otherwise shaped according to the desired deployment and / or control of the frame 1500 from the outer tube 4910.

[0053] Next, referring to FIGS. 14A - 16 and FIGS. 29A - 30E, the connector body 4914, for example, the connector body of the lock and release connector 7000, can take various forms. The somewhat diverse forms may be based on the proximal end portion 12 of the frame 1500. For example, the connector body 4914 can have one recess 5710 (e.g., a T - shaped recess) (FIGS. 29A - 29C) and hold one extension portion 5000, or can include a plurality of recesses and hold a plurality of extension portions (e.g., two T - shaped recesses 5710 that hold two extension portions 5000 while the distal end portion of the frame 1500 expands). Each recess 5710 includes a door 7020 connected (e.g., hinged, flexibly connected, etc.) to the connector body 4914 as described above and can receive the head 5636 of the corresponding extension portion 5000. The recess 5710 and the door 7020 can correspond to the number, shape, spacing, and size of the extension portions 5000 of the frame 1500. Optionally, one or more fasteners 7040 (see FIG. 16) can be used to connect the door 7020 to the connector body 4914. In some embodiments, the fastener 7040 can be a hinge pin. The fastener can be a wire, screw, hinge, suture, string, pin, etc. The body 7010 and the door 7020 can be hingedly connected or flexibly attached by any fastener known in the art.

[0054] Connector 4914, such as a lock and release connector 7000, may further include a mechanism (e.g., one or more springs 7050 or similar mechanism) that can exert a force on door 7020 to bias the door open. In some embodiments, door 7020 is controlled by one or more control wires to translate door 7020 from a first position to a second position, including from a closed state to an open state and from an open state to a closed state. In some embodiments, door 7020 may be made of a shape memory or pseudoelastic material, such as a shape memory alloy, including but not limited to copper-aluminum-nickel alloys and nickel-titanium alloys, an example of which is nitinol. Due to the shape memory material or superelastic material, door 7020 can be compressed into a closed state, including but not limited to a partially closed position, to engage with body 7010. Thereafter, when the compressive force is released (e.g., when deployed from a catheter), door 7020 self-expands to return to its open state prior to compression. In this embodiment, fastener 7040 may be omitted. For example, body 7010 and door 7020 may be integrally formed or fixed to each other, and door 7020 may bend from a first position to a second position, including from a closed position to an open position.

[0055] Referring to FIGS. 29A-29E, the connector 4914 includes a recess 5710 (e.g., one T-shaped recess, or a recess of another type of shape) and can receive the head 5636 of the elongated extension 5000, e.g., the single elongated extension 5000 of FIG. 9B. The length of the recess 5710 can correspond to the length of the elongated extension 5000 and can be longer than the recess 5710 of FIGS. 14A-16. The cross portion of the recess 5710 can be remote from the distal end of the connector 4914, whereby the door 7020 does not open and / or move to a second position until the connector body 4914 is further moved from the catheter. Since the recess 5710 (e.g., the T-shaped recess) is disposed more distally rearward on the connector body 4914, the connector assembly 7000 can hold the extension 5000 of the frame 1500 longer than the connector of FIGS. 14A-16 when the outer tube / sheath 4910 is moved rearward or retracted relative to the device 10 (or when the stent is moved forward relative to the outer tube 4910).

[0056] Door 7020 can have a variety of different sizes and shapes. Door 7020 can be made shorter such that the end of door 7020 does not reach the end of connector body 4914 (FIG. 29D), or door 7020 can be made longer such that the end of door 7020 aligns with or extends beyond the end of connector body 4914 (FIG. 29E). As shown in FIG. 29D, the shorter door 7020 can hold the head 5636 of the elongate extension 5000, with the remainder of the extension 5000 being free. With the shorter door 7020, the elongate extension 5000 can bend or otherwise be further adjusted before opening door 7020 and releasing frame 1500. Thereby, frame 1500 can expand radially more smoothly when frame 1500 is moved distally beyond the distal opening 7060 of outer tube 4910. As shown in FIG. 29E, the elongate door 7020 aligns with the end of the connector body and can hold the head 5636 and a substantial portion of the elongate extension 5000. The elongate door 7020 allows for further control of the position of extension 5000 before opening door 7020 and releasing frame 1500. Thereby, the position of frame 1500 is more easily maintained or otherwise controlled when frame 1500 is moved distally beyond the distal opening 7060 of outer tube 4910. In either of these configurations, the elongate extension 5000 of frame 1500 can be held by door 7020 after frame 1500 is substantially deployed from outer tube 4910 and substantially or fully expanded radially outward.

[0057] Referring to FIGS. 30A - 30E, the connector body 4914 includes a first recess 5710a (e.g., a first T-shaped recess or other shape) and a second recess 5710b (e.g., a second T-shaped recess or other shape) and can receive the heads 5636 (e.g., the two heads of FIG. 9B) of the two different length extensions 5000a, 5000b. The first recess 5710a and the second recess 5710b can be arranged on the connector body 4914 in any manner corresponding to the extensions 5000a, 5000b of the frame 1500. In the illustrated embodiment, the first recess 5710a and the second recess 5710b are arranged substantially on both sides of the connector body 4914. However, the first recess 5710a and the second recess 5710b may be arranged in other arrangements. For example, the first recess 5710a and the second recess 5710b can be arranged adjacent to each other to correspond to the extensions 1500 arranged on the adjacent struts 1502 of the frame 1500. The first recess 5710a can be covered by a corresponding first door 7020a, and the second recess 5710b can be covered by a corresponding second door 7020b that is hingedly connected to the connector body 4914, e.g., the lock and release connector 7000, in any of the manners described above.

[0058] The first recess 5710a may be elongated to receive the head 5636 of an elongated extension 5000, e.g., the elongated second extension 5000b of FIG. 9A. Similar to the recess 5710 of FIGS. 29A-29C, in the illustrated T-shaped embodiment, the cross portion of the first recess 5710a may be disposed proximally away from the distal end of the connector body 4914, whereby the pivot connection of the first door 7020a is disposed further rearward on the connector body 4914. Since the pivot connection of the first door 7020a is disposed further rearward on the connector body 4914, the first door 7020a can hold the extension 5000 of the frame 1500 longer than the connector of FIGS. 14A-16 when the outer tube / sheath 4910 is moved rearward or retracted relative to the device 10 (or when the stent is moved forward relative to the outer tube 4910). Similar to the door 7020 of FIGS. 29D and 29E, the first door 7020a may be elongated or shortened.

[0059] The second recess 5710b may be sized similar to the recess 5710 of FIGS. 14A-16 and may receive the head 5636 of the shorter extension 5000a of FIG. 9A. In the illustrated T-shaped embodiment, the cross portion of the second recess 5710b and the pivot connection of the door are disposed proximally closer to the distal end of the connector body 4914 than the first recess 5710a and the pivot connection of the first door. Since the pivot connection of the second door 7020b is disposed proximally closer to the distal end of the connector body 4914, the second door 7020b can release the extension 5000a of the frame 1500 earlier than the first door 7020a when the outer tube / sheath 4910 is moved rearward or retracted relative to the device 10 (or when the stent is moved forward relative to the outer tube 4910).

[0060] In use, one elongated extension 5000b of the frame 1500 can be held within the first recess 5710a by the first door 7020a, and one shorter extension 5000a of the frame 1500 can be held within the second recess 5710b by the second door 7020b. When the outer tube / sheath 4910 is moved rearward or retracted relative to the device 10 (or when the stent is moved forward relative to the outer tube 4910), the second door 7020b moves through the distal opening 7060 of the outer tube 4910, releasing the held extension 5000a, and the elongated extension 5000b is held within the first recess 5710a by the first door 7020a. While the elongated extension 5000b is held within the first recess 5710a, the position of the frame 1500 can be maintained or otherwise controlled. Once the frame 1500 is radially expanded at the desired position, the outer tube / sheath 4910 can be moved rearward or retracted relative to the device 10 (or the stent can be moved forward relative to the outer tube 4910), whereby the first door 7020a is moved distally beyond the distal opening 7060 of the outer tube 4910, thereby releasing the elongated extension 5000b. By successively releasing the extensions 5000a, 5000b, the frame 1500 can expand radially more smoothly when the frame 1500 is moved distally beyond the distal opening 7060 of the outer tube 4910, and the position of the frame 1500 can be more easily maintained or otherwise controlled when the frame 1500 is moved distally beyond the distal opening 7060 of the outer tube 4910.

[0061] Having only one extension or only one elongated extension on a self-expandable frame acts to prevent the frame from protruding from the distal end of the catheter and disturbing the placement. As the proximal end of the frame approaches the distal opening of the delivery catheter, a force can build up between the proximal end of the frame and the distal opening of the catheter, and this force can cause the frame to project forward from the catheter. By having a plurality of extensions at the proximal most end of the frame, the extensions can act against each other and create opposing forces against the distal end of the catheter, thus increasing the likelihood of projection. If the frame has only one elongated extension (regardless of the presence or absence of additional shorter extensions) or only one extension, the frame can expand sufficiently while being held by the single extension, and then this one remaining extension can release the frame without causing projection.

[0062] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the embodiments shown are merely preferred examples of the invention and are not to be understood as limiting the scope of the invention. All combinations and sub - combinations of the features of the foregoing exemplary embodiments are contemplated by this application. Similarly, all combinations and sub - combinations of the steps / methods of the foregoing embodiments are contemplated, and the steps described may be combined in various ways and orders. The scope of the invention is defined by the following claims. Accordingly, all that is included in the spirit and scope of these claims is claimed as the invention.

Description of the Reference Numerals

[0063] 10 Implantable medical device 12 Proximal inflow end 14 Distal outflow end 16 Narrow portion 18 Valve seat 21 Outer covering / material 28 Nose cone 212 Opening 410 Seal portion 414 Retaining portion 416 Inner surface 1400 Permeable portion 1404 Impermeable portion 1500 Frame 1502 Metal strut 1504 Cell 1510 End 2000 Portion extending radially outward 2100 Region 2130 Region 3600 Catheter 4910 Outer tube 4912 Inner tube 4914 Connector 4916 Connecting tube 5000 Extension 5000a First extension 5000b Second extension 6390 Guide wire lumen 5002 Guide wire 5600 Surface 5636 Head 5638 Straight portion 5640 Side surface 5710 T-shaped recess 5710a First recess 5710b Second recess 7000 Lock and release connector 7010 Body 7020 Door 7020a First door 7020b Second door 7040 Fastener 7050 Spring 7060 Distal opening H Heart RV Right ventricle LV Left ventricle TV Tricuspid valve MV Mitral valve RA Right atrium LA Left atrium AV Aortic valve PV Pulmonary valve PA Pulmonary Artery SVC Superior Vena Cava IVC Inferior Vena Cava CS Coronary Sinus

Claims

1. A system comprising a body, and a lock and release connector including at least two first and second doors engaged with the body, the first and second doors being movable from a first position to a second position, the lock and release connector; an outer tube having a distal opening; an implantable medical device disposed within the outer tube, the medical device having a first extension; the first extension being disposed between the body and the first door; the implantable medical device further including at least a second extension; a distal end of the second extension extending beyond a distal end of the first extension in a direction from a distal end of the implantable medical device to a proximal end of the implantable medical device; the lock and release connector being configured to release the first extension before releasing the second extension, whereby the implantable medical device is fully extensible after the first extension is released and before the second extension is released; the first and second doors being continuously movable from their respective first positions to their respective second positions; the lock and release connector further including at least two springs that exert a force on the first and second doors and are separate from the first and second doors.

2. The system of claim 1, wherein the door is integral with the body.

3. The system of claim 1 or 2, wherein the door is connected to the body.

4. The system according to any one of claims 1 to 3, wherein the door is hingedly connected to the body.

5. The door comprises a shape memory material and is the system according to any one of claims 1 to 4.

6. The system according to any one of claims 1 to 5, further comprising at least one fastener connecting at least one end of the door to the body.

7. The system according to any one of claims 1 to 6, wherein the door is actively controlled to move from a first position to a second position.

8. The system according to any one of claims 1 to 7, further comprising a wire, a screw, a separate hinge, or a pin connecting the body and the door.

9. A catheter assembly, comprising a body and a lock and release connector including at least two first and second doors engaged with the body, wherein the first and second doors are movable from a first position to a second position, the lock and release connector, an outer tube having a distal opening, an inner tube disposed within the outer tube, an implantable medical device disposed within the outer tube, the medical device having a first extension, the implantable medical device, and, the lock and release connector is connected to the inner tube, the first extension is disposed between the body and the first door, the implantable medical device further comprises at least a second extension, a distal end of the second extension extends further than a distal end of the first extension in a direction from a distal end of the implantable medical device to a proximal end of the implantable medical device, The lock and release connector is configured to release the first extension before releasing the second extension, whereby the implantable medical device is fully expandable after the first extension is released and before the second extension is released. The first and second doors are each continuously movable from their respective first positions to their respective second positions. The lock and release connector further includes at least two springs that exert a force on the first and second doors and are separate from the first and second doors, a catheter assembly.

10. The first extension moves the first door from the first position to the second position, the catheter assembly according to claim 9.

11. A lock and release connector for a transcatheter implantable device, A body, At least two first and second doors engaged with the body, the doors being movable from a first position to a second position, at least two first and second doors, comprising. The transcatheter implantable device has a first extension, The first extension is disposed between the body and the first door. The transcatheter implantable device further includes at least a second extension, The distal end of the second extension extends further than the distal end of the first extension in a direction from the distal end of the transcatheter implantable device to the proximal end of the transcatheter implantable device. The lock and release connector is configured to release the first extension before releasing the second extension, whereby the transcatheter implantable device is fully expandable after the first extension is released and before the second extension is released. The first and second doors are each movable continuously from their respective first positions to their respective second positions. The lock and release connector further includes at least two springs that exert force on the first and second doors and are separate from the first and second doors.

12. The door is integral with the body, the lock and release connector according to claim 11.

13. The door is connected to the body, the lock and release connector according to claim 11 or 12.

14. The door is hingedly connected to the body, the lock and release connector according to any one of claims 11 to 13.

15. The door includes a shape memory material, the lock and release connector according to any one of claims 11 to 14.

16. The door includes a nickel-titanium alloy, the lock and release connector according to any one of claims 11 to 15.

17. The lock and release connector according to any one of claims 11 to 16 further includes at least one fastener that connects at least one end of the door to the body.

18. The door is actively controlled to move from a first position to a second position, the lock and release connector according to any one of claims 11 to 17.

19. The lock and release connector according to any one of claims 11 to 18 further includes a wire, screw, separate hinge, or pin that connects the body and the door.

20. The lock and release connector according to claim 11, further configured to move the first door to the second position such that the first implantable medical device extension is releasable from the first door and the second extension continues to be held under the second door.

Images