Everting leaflet delivery system with pivoting

A replacement heart valve may comprise a tubular anchor member actuatable between an elongated delivery configuration and an expanded deployed configuration, a buckle member fixedly attached to the anchor member, a post member axially translatable relative to the buckle member, an actuator member including a suture member forming a loop unreleasably attached to a distal end thereof, the actuator member being releasably connected to a proximal end of the post member by the loop, a release pin extending axially along the actuator member and through the loop in a first position, wherein axial translation of the release pin to a second position proximal the first position disconnects the actuator member from the post member, and a valve leaflet attached to the post member.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods for manufacturing and/or using medical devices. More particularly, the present disclosure pertains to locking mechanisms for a replacement heart valve.

BACKGROUND

SUMMARY

In a first aspect, a replacement heart valve locking mechanism may comprise a buckle member fixedly attached to a tubular anchor member, a post member axially translatable relative to the buckle member, an actuator member including a suture member forming a loop unreleasably attached to a distal end thereof, the actuator member being releasably connected to a proximal end of the post member by the loop, and a release pin extending axially along the actuator member and through the loop in a first position, wherein axial translation of the release pin to a second position proximal the first position disconnects the actuator member from the post member.

In addition or alternatively, and in a second aspect, the post member, when positioned within the buckle member, is movable distally relative to the buckle member when the release pin is in the first position.

In addition or alternatively, and in a third aspect, the post member includes a latch portion configured to engage the buckle member such that movement of the post member distally relative to the buckle member is prevented after the release pin is translated to the second position.

In addition or alternatively, and in a fourth aspect, the release pin extends through at least a portion of the actuator member.

In addition or alternatively, and in a fifth aspect, the post member includes a longitudinally-oriented groove configured to receive a distal portion of the release pin therein.

In addition or alternatively, and in a sixth aspect, the groove extends from a proximal end of the post member to a distal end of the post member.

In addition or alternatively, and in a seventh aspect, the distal portion of the release pin is axially translatable within the groove.

In addition or alternatively, and in an eighth aspect, the actuator member is pivotable relative to the post member.

In addition or alternatively, and in a ninth aspect, when the actuator member is releasably connected to a proximal end of the post member by the loop, the actuator member is axially translatable through the buckle member.

In addition or alternatively, and in a tenth aspect, when the release pin is in the first position, the loop passes through a proximal portion of the post member.

In addition or alternatively, and in an eleventh aspect, the loop extends distally from the distal end of the actuator member, passes transversely through the proximal portion of the post member, and then extends proximally past the distal end of the actuator member to an engagement location where the release pin extends through the loop when the release pin is in the first position.

In addition or alternatively, and in a twelfth aspect, a replacement heart valve may comprise a tubular anchor member actuatable between an elongated delivery configuration and an expanded deployed configuration, a buckle member fixedly attached to the anchor member, a post member axially translatable relative to the buckle member, an actuator member including a suture member forming a loop unreleasably attached to a distal end thereof, the actuator member being releasably connected to a proximal end of the post member by the loop, a release pin extending axially along the actuator member and through the loop in a first position, wherein axial translation of the release pin to a second position proximal the first position disconnects the actuator member from the post member, and a valve leaflet attached to the post member. The post member may be disposed distal of the anchor member when the anchor member is in the elongated delivery configuration, the post member including a latch portion configured to engage the buckle member when the anchor member is in the deployed configuration and the release pin is in the second position.

In addition or alternatively, and in a thirteenth aspect, the post member, when positioned within the buckle member, is movable distally relative to the buckle member when the release pin is in the first position.

In addition or alternatively, and in a fourteenth aspect, the latch portion is configured to engage the buckle member such that movement of the post member distally relative to the buckle member is prevented after the release pin is translated to the second position.

In addition or alternatively, and in a fifteenth aspect, the post member includes a longitudinally-oriented groove configured to receive a distal portion of the release pin therein.

In addition or alternatively, and in a sixteenth aspect, the groove extends from a proximal end of the post member to a distal end of the post member.

In addition or alternatively, and in a seventeenth aspect, the distal portion of the release pin is axially translatable within the groove.

In addition or alternatively, and in an eighteenth aspect, the actuator member is pivotable relative to the post member.

In addition or alternatively, and in a nineteenth aspect, when the anchor member is in the delivery configuration, the actuator member is positioned alongside the post member in a generally parallel, non-coaxial arrangement.

In addition or alternatively, and in a twentieth aspect, when the anchor member is in the deployed configuration, the actuator member is positioned in a generally coaxial, end-to-end arrangement with the post member.

The above summary of some embodiments, aspects, and/or examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the claimed invention. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the claimed invention.

All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about”, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Other uses of the term “about” (i.e., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

Relative terms such as “proximal”, “distal”, “advance”, “retract”, variants thereof, and the like, may be generally be considered with respect to the positioning, direction, and/or operation of various elements relative to a user/operator/manipulator of the device, wherein “proximal” and “retract” indicate or refer to closer to or toward the user and “distal” and “advance” indicate or refer to farther from or away from the user.

Diseases and/or medical conditions that impact the cardiovascular system are prevalent in the United States and throughout the world. Traditionally, treatment of the cardiovascular system was often conducted by directly accessing the impacted part of the system. For example, treatment of a blockage in one or more of the coronary arteries was traditionally treated using coronary artery bypass surgery. As can be readily appreciated, such therapies are rather invasive to the patient and require significant recovery times and/or treatments. More recently, less invasive therapies have been developed, for example, where a blocked coronary artery could be accessed and treated via a percutaneous catheter (e.g., angioplasty). Such therapies have gained wide acceptance among patients and clinicians.

Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. For example, failure of the aortic valve can have a serious effect on a human and could lead to serious health condition and/or death if not dealt with. Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve. Such therapies may be highly invasive to the patient. Disclosed herein are medical devices that may be used for delivering a medical device to a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system. At least some of the medical devices disclosed herein may be used to deliver and implant a replacement heart valve (e.g., a replacement aortic valve). In addition, the devices disclosed herein may deliver the replacement heart valve percutaneously and, thus, may be much less invasive to the patient. The devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below.

FIG. 1illustrates a portion of an example medical implant system10. It should be noted that some features of the medical implant system10are either not shown, or are shown schematically, inFIG. 1for simplicity. Additional details regarding some of the components of the medical implant system10may be provided in other figures in greater detail. A medical implant system10may be used to deliver and/or deploy a variety of medical devices to a number of locations within the anatomy. In at least some embodiments, the medical implant system10may be a replacement heart valve system (e.g., a replacement aortic valve system) that can be used for percutaneous delivery of a replacement heart valve. This, however, is not intended to be limiting as the medical implant system10may also be used for other interventions including mitral valve replacement, valve repair, valvuloplasty, and the like, or other similar interventions.

The medical implant system10may generally be described as a catheter system that includes a delivery system12and a medical implant14(i.e., a replacement heart valve, for example, which term may be used interchangeably with the term “medical implant” herein) which may be coupled to the delivery system12and disposed within a lumen of the delivery system12during delivery of the medical implant14. In some embodiments, a handle18may be disposed at a proximal end of the delivery system12, and may include one or more actuation means associated therewith. In general, the handle18may be configured to manipulate the position of the delivery system12and/or aid in the deployment of the medical implant14.

In use, the medical implant system10may be advanced percutaneously through the vasculature to a position adjacent to an area of interest. For example, the medical implant system10may be advanced through the vasculature and across the aortic arch to a position adjacent to a defective aortic valve. Alternative approaches to treat a defective aortic valve or other heart valve(s) are also contemplated with the medical implant system10. During delivery, the medical implant14may be generally disposed in an elongated and low profile “delivery” configuration within the delivery system12. Once positioned, the delivery system12may be retracted relative to the medical implant14to expose the medical implant14. In at least some embodiments, the medical implant14may be disposed in an “everted” configuration or a partially-everted configuration, as seen inFIG. 3, for example, while disposed within the delivery system12and/or immediately upon exposure after retracting the delivery system12. In some embodiments, the “delivery” configuration and the “everted” configuration may be substantially similar and/or may be used interchangeably herein. The medical implant14may be actuated using the handle18in order to translate the medical implant14into a generally shortened and larger profile “deployed” configuration suitable for implantation within the anatomy (as shown inFIG. 2, for example). When the medical implant14is suitably deployed within the anatomy, the delivery system12can be disconnected from the medical implant14and the delivery system12removed from the vasculature, leaving the medical implant14in place in a “released” configuration to function as, for example, a suitable replacement for the native aortic valve. In at least some interventions, the medical implant14may be deployed within the native valve (e.g., the native valve is left in place and not excised). Alternatively, the native valve may be removed and the medical implant14may be deployed in its place as a replacement.

In some embodiments, the delivery system12may include one or more lumens extending therethrough. For example, in some embodiments, the delivery system12may include a first lumen, a second lumen, a third lumen, and a fourth lumen. In general, the one or more lumens extend along an entire length of the delivery system12. Other embodiments are contemplated, however, where one or more of the one or more lumens extend along only a portion of the length of the delivery system12. For example, in some embodiments, the fourth lumen may stop just short of a distal end of the delivery system12and/or be filled in at its distal end to effectively end the fourth lumen proximal of the distal end of the delivery system12.

Disposed within a first lumen of the delivery system12may be at least one actuator member50, such as an actuator member50for example, which may be used to actuate (i.e., expand and/or elongate) the medical implant14between a delivery configuration and a deployed configuration. In some cases, the actuator member(s)50may herein be referred to, or used interchangeably with, the term “actuator element”. In some embodiments, the medical implant system10may include at least one actuator member50. In some embodiments, the at least one actuator member50may include a plurality of actuator members50, two actuator members50, three actuator members50, four actuator members50, or another suitable or desired number of actuator members50. For the purpose of illustration only, the medical implant system10and/or the medical implant14is shown with three actuator members50. In some embodiments, the medical implant system10and/or the medical implant14may include at least one release pin20, which may be used to actuate the medical implant14from the deployed configuration to the released configuration, as will be made apparent herein. In some embodiments, the medical implant system10may include at least one release pin20. In some embodiments, the at least one release pin20may include two release pins20, three release pins20, four release pins20, or another suitable or desired number of release pins20. For the purpose of illustration only, the medical implant system10and/or the medical implant14is shown with three release pins20. In some embodiments, each of the at least one release pin20may correspond to and/or be paired with one or each of the at least one actuator member50.

In at least some embodiments, the first lumen may be lined with a low friction liner (e.g., a FEP liner). In some embodiments, disposed within a second lumen may be at least one release pin20(for example, one release pin20for each actuator member50). In some embodiments, the at least one release pin20may extend through at least a portion of corresponding actuator member(s)50within the first lumen. In at least some embodiments, the second lumen may be lined with a hypotube liner. A third lumen may be a guidewire lumen and in some embodiments, the third lumen may also be lined with a hypotube liner. In some embodiments, a fourth lumen may be used to house a non-stretch wire or other reinforcing member. The form of the non-stretch wire or other reinforcing member may vary. In some embodiments, the non-stretch wire may take the form of a stainless steel braid. The non-stretch wire may optionally include a pair of longitudinally-extending aramid and/or para aramid strands (for example, KEVLAR®) disposed on opposite sides of the braid. In general, rather than being “disposed within” the fourth lumen, the non-stretch wire may be embedded within the fourth lumen. In addition, the non-stretch wire may extend to a position adjacent to a distal end region but not fully to the distal end of the delivery system12. For example, a short distal segment of the fourth lumen may be filled in with polymer material adjacent to the distal end of the delivery system12.

The delivery system12may also include a guidewire tube extension that extends distally from the distal end region. In some embodiments, a nose cone may be attached to the guidewire tube extension. In some embodiments, the nose cone generally is designed to have an atraumatic shape. In some embodiments, the nose cone may also include a ridge or ledge that is configured to abut the distal tip of the delivery system12during delivery of the medical implant14.

FIGS. 2-3illustrate some selected components of the medical implant system10and/or the medical implant14in the deployed and/or everted configuration. For example, here it can be seen that the medical implant14may include a plurality of valve leaflets16(e.g., bovine pericardial) which may be secured to a tubular anchor member or braid40that is reversibly actuatable between a “delivery” and/or “everted” configuration, and a “deployed” configuration. In some embodiments, the anchor member or braid40may be substantially cylindrical in shape or configuration. In some embodiments, the anchor member or braid40may define a central longitudinal axis extending therethrough along a fluid flow path through the medical implant14. Other shapes and/or configurations are also contemplated. Some suitable but non-limiting materials for the anchor member or braid40, for example metallic materials or polymeric materials, may be described below.

In some embodiments, the medical implant14may include a plurality of locking mechanisms configured to secure the anchor member or braid40in the “deployed” configuration. In some embodiments, the at least one actuator member50may be configured to engage with the plurality of locking mechanisms and actuate the anchor member or braid40between the “delivery” configuration and the “deployed” configuration. In some embodiments, one actuator member50may correspond to, engage with, and/or actuate one locking mechanism. In some embodiments, one actuator member50may correspond to, engage with, and/or actuate more than one locking mechanism. Other configurations are also contemplated.

FIGS. 4-11illustrate the general relationship and operation of selected components of a locking mechanism configured to lock the medical implant14(and/or the anchor member or braid40) in the “deployed” configuration. For simplicity and clarity purposes, not all elements of the disclosed invention are necessarily shown in each figure. In some illustrative examples, only one of the fingers34of the coupler32, only one of the plurality of actuator members50, only one of the post members76, only one of the buckle members58, only one of the collars36, and only one of the release pins20are shown and discussed (the whole medical implant14and/or the anchor member or braid40is not shown to facilitate understanding of the locking mechanisms). However, it will be understood that the following discussion may apply equally to any and/or all of the components for which there are more than one within the medical implant14(i.e., the plurality of actuator members50, the buckle members58, the post members76, the release pins20, etc.) and/or the medical implant system10.

As seen inFIG. 2, and discussed in more detail below, each actuator member50and associated release pin20extends through a guide38adjacent to and covering a finger34of the coupler32, through a collar36coupling and/or locking the finger34to a buckle member58, through the buckle member58, and connected to a post member76.

While a plurality of actuator members50, release pins20, other elements, and/or corresponding locking mechanisms may be included in a medical implant14, for clarity and brevity, much of the following discussion will be limited to a single instance of these elements. The skilled person will readily recognize that the features and operation of the examples discussed below may apply equally to and across all instances of the disclosed elements (i.e., each locking mechanism, each actuator member50, each release pin20, etc.). Some suitable but non-limiting materials for the locking mechanisms, the actuator members50, the release pins20, etc., for example metallic materials or polymeric materials, may be described below.

In some embodiments, the plurality of locking mechanisms may each comprise an axially movable post member76, for example at the commissure portions of the valve leaflets16(post member76may sometimes be referred to as a “commissure post”, which may serve to secure the valve leaflets16, or the post member76may be connected and/or attached to (or otherwise be considered a part of) a commissure post72, which itself may have one or more post elements), and a buckle member58fixedly attached to the anchor member or braid40. In some embodiments, the commissure post72and the post member76may be a single, unitary and/or monolithic structure. In some embodiments, the commissure post72and the post member76may be fixed and/or generally non-movable relative to each other (i.e., prevented from rotating, prevented from sliding, prevented from translating, etc. relative to each other). In at least some embodiments, a medical implant14may include a plurality of post members76and/or commissure posts72, and a corresponding plurality of buckle members58. Other configurations and correspondences are also contemplated.

In some embodiments, the post member76may engage the buckle member58in the “deployed” configuration, and consequently, in the “released” configuration. In some embodiments, the post member76may be axially and/or longitudinally spaced apart from the buckle member58in the “delivery” configuration and/or the “everted” configuration. Some suitable but non-limiting materials for the post member76and/or the buckle member58, for example metallic materials or polymeric materials, may be described below.

In some embodiments, a distal end of the axially movable post member76and/or the commissure post72may be secured and/or attached (i.e., fixedly attached, movably attached, removably attached, etc.) to a distal portion of the anchor member or braid40, such as by a suture74, a tether, adhesives, or other suitable element. In some embodiments, the post member76may be movable relative to the anchor member or braid40, and the buckle member58. In some embodiments, the post member76may be axially or longitudinally movable relative to the anchor member or braid40, and the buckle member58. In some embodiments, the buckle member58may be fixedly attached to the anchor member or braid40. Other embodiments are contemplated where the buckle member58may be movably or removably attached to the anchor member or braid40. In some embodiments, the post member76may be fixedly attached to the anchor member or braid40and the buckle member58may be fixedly attached to the anchor member or braid40. In some embodiments, one of the post member76and the buckle member58may be fixedly attached to the anchor member or braid40and the other may be movably or removably attached to the anchor member or braid40. In some embodiments, the post member76may be movably or removably attached to the anchor member or braid40and the buckle member58may be movably or removably attached to the anchor member or braid40. In some embodiments, the post member76may be secured or attached (i.e., fixedly attached, movably attached, removably attached, etc.) to a distal end of the anchor member or braid40. In some embodiments, the buckle member58may be fixed or attached to a proximal portion of the anchor member or braid40. In some embodiments, the buckle member58may be fixed or attached at or to a proximal end of the anchor member or braid40.

In some embodiments, the medical implant14may include one or more of the plurality of valve leaflets16secured to the anchor member or braid40at, adjacent to, and/or using (at least in part) individual, corresponding commissure posts72and/or post members76. In some embodiments, the plurality of valve leaflets16may also be secured to a base, or the distal end, of the anchor member or braid40. As such, when the commissure post72and/or the post member76is pulled proximally to engage the buckle member58, as will be described herein, the distal end of the anchor member or braid40is also pulled proximally relative to the buckle member58, thereby transitioning from the “delivery” configuration and/or the “everted” configuration toward the “deployed” configuration. In some embodiments, the plurality of valve leaflets16may be coupled and/or secured (i.e., to the commissure post72, to the anchor member or braid40, and/or back to themselves) using one or more sutures, threads, wires, filaments, or other suitable elements. In some embodiments, the plurality of valve leaflets16may be coupled and/or secured (i.e., to the commissure post72, to the anchor member or braid40, and/or back to themselves) using an adhesive, a bonding agent, or other suitable securing means. In some embodiments, the plurality of valve leaflets16may be coupled and/or secured (i.e., to the commissure post72, to the anchor member or braid40, and/or back to themselves) using a fabric, a textile, or other thin flexible material.

In some embodiments, the anchor member or braid40may have a total of three buckle members58and three post members76attached and/or secured thereto. Similarly, one actuator member50may be operatively associated with each post member76and buckle member58, for a total of three actuator members50in the illustrated examples. Other embodiments are contemplated where fewer or more buckle members58, commissure posts72, post members76, actuator members50, and release pins20may be utilized. In some embodiments, a seal44may be disposed about the anchor member or braid40and, as the term suggests, may help to seal an exterior of the medical implant14within and/or against a target site or area of interest upon deployment, thereby preventing leakage around the medical implant14.

In some embodiments, attachment between the medical implant14and the delivery system12may be effected through the use of a coupler32. In some embodiments, the coupler32may generally include a cylindrical base (not shown) that may be disposed about, attached to, and/or extending from the delivery system12. Projecting distally from the base is a plurality of fingers34(e.g., two, three, four, etc.) that are each configured to engage with the medical implant14at a proximal end of one of the buckle members58. A collar36may be disposed about the fingers34of the coupler32to further assist in holding together the fingers34and the buckle members58, as will be described in more detail below. As mentioned above, a release pin20may be slidably associated with, disposed slidably alongside, and/or axially extending through at least a portion of each actuator member50. A guide38may be disposed over each of the fingers34proximal of the collar36and may serve to keep the fingers34of the coupler32associated with the plurality of actuator members50(and corresponding release pins20) extending adjacent to (and axially slidable relative to) the fingers34of the coupler32. Finally, the release pin20and/or a suture member30may be a linking structure that keeps post members76, buckle members58, and actuator members50associated with one another. Some suitable but non-limiting materials for the coupler32, the plurality of fingers34, the collar36, the guide38, the handle18, and/or the plurality of individual release pins20, for example metallic materials or polymeric materials, may be described below.

In some embodiments, a buckle member58may include a proximal end and a distal end disposed opposite the proximal end. In some embodiments, the buckle member58may include a back wall extending from the proximal end to the distal end. In some embodiments, the buckle member58may include two axially-extending side walls extending radially inward toward the central longitudinal axis away from the back wall and/or the anchor member or braid40, when the buckle member58is attached thereto. In some embodiments, the back wall may be configured to matingly engage a radially inner surface of the anchor member or braid40, such that the back wall is disposed radially distant from the central longitudinal axis of the anchor member or braid40relative to the two side walls. In some embodiments, the back wall may include a curved outer surface configured to mate with and/or lie against an inner surface of the tubular anchor member or braid40. In some embodiments, the buckle member58may be fixedly attached to the anchor member or braid40.

In some embodiments, the buckle member58may include a flap portion60disposed opposite the back wall and self-biased radially outward toward the back wall. In at least some embodiments, the flap portion60may be configured to deflect and/or flex radially inward toward the central longitudinal axis when the post member76is disposed within the buckle member58between the back wall and the flap portion60.

In some embodiments, the buckle member58may be substantially rigid. In some embodiments, the buckle member58may be formed from a metallic material, a polymeric material, a ceramic material, a composite material, or other suitable materials or combinations thereof. In some embodiments, the buckle member58may be partially rigid and/or partially flexible. In some embodiments, a buckle member58may permit an actuator member50and/or a post member76to be slidably received within and/or axially translate therethrough. In some embodiments, the buckle member58may be configured to prevent the actuator member50and/or the post member76from exiting the buckle member58in a radially inward direction toward the central longitudinal axis of the anchor member or braid40, thereby limiting motion of the actuator member50and/or the post member76within the anchor member or braid40to axial translation.

In some embodiments, a post member76may include a proximal end and/or a latch portion80, and a distal end. In some embodiments, the post member76may be reversibly actuatable between a first orientation, wherein the proximal end and/or the latch portion80extends distally of a remainder of the post member76(e.g., in the “delivery” and/or “everted” configuration), and a second orientation, wherein the proximal end and/or the latch portion80extends proximally of the remainder of the post member76.

In some embodiments, the post member76may be axially translatable relative to the buckle member58. In some embodiments, the proximal end and/or the latch portion80may include an aperture or passage passing transversely or circumferentially (with respect to the anchor member or braid40and/or the central longitudinal axis) therethrough configured to receive a suture member30therethrough. In some embodiments, the latch portion80may include a transversely-oriented ridge configured to engage with the flap portion60of the buckle member58when the post member76is in the second orientation, such that movement of the post member76distally relative to the buckle member58is prevented. In some embodiments, the post member76may include a longitudinally-oriented groove78extending along a length thereof. In some embodiments, the longitudinally-oriented groove78may extend from a proximal end and/or a latch portion80of the post member76to a distal end of the post member76. In some embodiments, the longitudinally-oriented groove78may extend along a radially-inward surface of the post member76relative to the central longitudinal axis when the post member76is disposed in the second orientation. In some embodiments, the longitudinally-oriented groove78may open radially inward toward the central longitudinal axis when the post member76is disposed in the second orientation.

In some embodiments, the post member76may be unitary with and/or integrally formed with the latch portion80as and/or from a single piece of material. In some embodiments, the post member76may be formed from a single piece of wire, flat stock, or other suitable material as discussed herein. In some embodiments, the post member76may be formed by further processing the single piece of wire, flat stock, or other suitable material, such as by machining, stamping, laser cutting, etc. Some suitable but non-limiting materials for the post member76and/or the latch portion80, for example metallic materials or polymeric materials, may be described below.

In some embodiments, an example actuator member50may include a proximal end and a distal end. In use, the proximal end may be connected to and/or manipulated or otherwise actuated by a user, for example using the handle18, to shift the medical implant14from a “delivery” configuration to a “deployed” configuration, and later to a “released” configuration. In some embodiments, the actuator member50may be axially translatable within and/or through the buckle member58. In some embodiments, the actuator member50may include an elongated rod and a distal end portion having one or more transverse or circumferential apertures extending therethrough. In some embodiments, the distal end portion may be integrally formed with or as a part of the elongated rod as a single monolithic structure. In some embodiments, the actuator member50may be prevented from rotating (i.e., is non-rotatable) relative to the buckle member58when the actuator member50is engaged with the buckle member58. In some embodiments, the actuator member50may be prevented from rotating (i.e., is non-rotatable) relative to the post member76when the actuator member50is engaged with and/or connected to the post member76.

In some embodiments, the actuator member50may include a suture member30forming a loop unreleasably attached to the distal end thereof. In some embodiments, the suture member30may extend and/or pass through the one or more transverse or circumferential apertures extending through the distal end portion of the actuator member50. In some embodiments, the distal end and/or the distal end portion of the actuator member50may be releasably connected to the proximal end and/or the latch portion80of the post member76by the loop. In some embodiments, the distal end portion may include an axial passage extending therethrough generally parallel to a longitudinal axis of the actuator member50. In at least some embodiments, the actuator member50may be pivotable relative to the post member76.

In some embodiments, the elongated rod may be generally round, oblong, ovoid, rectangular, polygonal (i.e., two-sided, three-sided, four-sided, five-sided, six-sided, etc.), etc. in shape. Other shapes, both regular and irregular, are also contemplated. In some embodiments, the actuator member50may be formed from a single piece of wire, round stock, or other suitable material. In some embodiments, the actuator member50may be formed by further processing the single piece of wire, round stock, or other suitable material, such as by machining, stamping, laser cutting, etc. Some suitable but non-limiting materials for the actuator member50, the elongated rod, and/or the distal end portion, for example metallic materials or polymeric materials, may be described below.

In some embodiments, an example release pin20may have a proximal end and a distal end. In use, the proximal end may be connected to and/or manipulated or otherwise actuated by a user, for example using the handle18, to shift the medical implant14into a “deployed” configuration, and later to a “released” configuration. In some embodiments, the release pin20may be disposed and/or axially translatable within and/or through the buckle member58, the longitudinally-oriented groove78of the post member76, and/or the axial passage of the distal end portion of the actuator member50. In some embodiments, the release pin20may extend through at least a portion of the actuator member50, for example the axial passage formed within the distal end portion of the actuator member50. In some embodiments, the post member76includes a longitudinally-oriented groove78configured to receive a distal portion of the release pin20therein. In some embodiments, a distal end portion of the actuator member50may include a longitudinally-oriented axial passage that may be aligned with the longitudinally-oriented groove78of the post member76when the post member76is disposed in the second orientation. When so aligned, a distal portion of the release pin20may be slidably and/or translatably disposed within the longitudinally-oriented groove78when the release pin20is in the first position.

In some embodiments, the release pin20may be axially translatable between a first position and a second position proximal the first position. In some embodiments, when the release pin20is in the first position, the loop of the suture member30may pass through the aperture or passage passing transversely or circumferentially through the proximal end and/or the latch portion80of the post member76. In other words, when the release pin20is in the first position, the loop of the suture member30may pass transversely through a proximal portion of the post member76. In some embodiments, when the release pin20is in the first position, the loop of the suture member30extends distally from the distal end and/or the distal end portion of the actuator member50, passes transversely through the proximal portion of the post member76(and/or the proximal end and/or the latch portion80of the post member76), and then extends proximally past the distal end of the actuator member50to an engagement location where the release pin20extends through the loop of the suture member30, thereby releasably connecting the actuator member50to the proximal end and/or the latch portion80of the post member76. In at least some embodiments, the engagement location may be disposed proximal of the distal end portion of the actuator member50.

In some embodiments, the release pin20may be disposed and/or positioned alongside, and/or aligned generally parallel with the actuator member50. In some embodiments, the release pin20may engage with the flap portion60of the buckle member58and/or may prevent engagement of the flap portion60of the buckle member58with the latch portion80of the post member76when the release pin20is in the first position and the post member76is engaged with and/or disposed within the buckle member58. In some embodiments, the latch portion80of the post member76may be configured to engage the flap portion60of the buckle member58such that movement of the post member76distally relative to the buckle member58is prevented after the release pin20is translated to the second position proximal of the first position. In some embodiments, when the release pin20is translated axially from the first position proximally to the second position, the release pin20is pulled through the loop of the suture member30, thereby releasing the loop of the suture member30and/or disconnecting the actuator member50from the post member76. In other words, after the release pin20has been translated to the second position, the latch portion80of the post member76engages the flap portion60of the buckle member58, distal movement of the post member76relative to the buckle member58is prevented, and the actuator member50may be pulled proximally away from the post member76and/or the buckle member58to leave the medical implant in the “released” configuration, as seen inFIG. 12for example.

General operation of some embodiments may be described as follows herein. During delivery, the medical implant14may be secured at the distal end of the delivery system12by virtue of the association of the fingers34of the coupler32being coupled with a projecting proximal end of the buckle member58(and being held in place with the collar36disposed over the connection) and by virtue of the release pins20securing together the actuator member50and the post member76, as described herein. As can be appreciated, a proximal end of the post member76and a distal end of the buckle member58may be longitudinally separated (as seen inFIGS. 3-4, for example) and, accordingly, the medical implant14may be in an elongated and generally low-profile “delivery” configuration and/or “everted” configuration suitable for percutaneous translation through a patient's anatomy to an area of interest and/or target site.

After the medical implant14is advanced to the target site or area of interest within a distal end of the delivery system12in the “delivery” configuration, as seen inFIG. 1for example, the delivery system12may be withdrawn or retracted to expose the medical implant14(or the medical implant14may be advanced distally relative to the delivery system12) in the “everted” configuration, as seen inFIG. 3for example. In the “delivery” configuration and/or the “everted” configuration, the actuator member50passes through the buckle member58and is positioned alongside the corresponding post member76in a generally parallel, non-coaxial arrangement. In the “delivery” configuration and/or the “everted” configuration, the post member76may be disposed in a first orientation, wherein the proximal end and/or the latch portion80of the post member76is disposed distal of the anchor member or braid40and/or the proximal end and/or the latch portion80is disposed distally of a remainder of the post member76.

Then, the handle18and/or the plurality of actuator members50can be used to axially shorten and/or radially expand and “lock” the medical implant14and/or the anchor member or braid40from the “delivery” configuration and/or the “everted” configuration toward an expanded or “deployed” configuration (as shown inFIG. 2, for example) by proximally retracting the actuator member50through the buckle member58, thereby causing the post member76to pivot relative to the actuator member50to rotate and/or pull the post member76from the first orientation through the anchor member or braid40and into a second orientation, wherein the proximal end and/or the latch portion80of the post member76is disposed proximally of the remainder of the post member76, and is disposed adjacent to and/or aligned with the buckle member58, as seen inFIGS. 4-6for example. As the post member76pivots and/or rotates through the anchor member or braid40, the proximal end and/or the latch portion80extends toward the central longitudinal axis of the anchor member or braid40. The actuator member50, releasably connected to the proximal end and/or the latch portion80of the post member76, may resiliently flex radially inwardly from the buckle member58toward the central longitudinal axis of the anchor member or braid40and then back outwardly toward the anchor member or braid40as the proximal end and/or the latch portion80of the post member76rotates over center (i.e., flips about a distal end thereof) such that the proximal end and/or the latch portion80is disposed proximally of the remainder of the post member76. As the post member76pivots and/or rotates through the anchor member or braid40and into the second orientation, a distal portion of the release pin20, which extends distally of a distal end of the actuator member50in a first position, is aligned with and/or received within the longitudinally-oriented groove78of the post member76. When the post member76is disposed in the second orientation, the actuator member50is positioned in a generally coaxial, end-to-end arrangement with the post member76.

Further proximal retraction of the actuator member50brings the proximal end and/or the latch portion80of the post member76into engagement with the buckle member58, as seen inFIGS. 7-9for example, wherein the post member76, when positioned within buckle member58, is movable distally relative to the buckle member58when the release pin20is in the first position. In other words, the actuator member50and/or the post member76may be translated distally relative to the buckle member58to actuate the anchor member or braid40back towards the “everted” configuration, so as to permit re-placement and/or re-sheathing of the medical implant14.

Finally, once the physician is satisfied with the placement and/or positioning of the medical implant14, the release pin20may be translated proximally from the first position wherein the release pin20is engaged with a longitudinally-oriented groove78in the post member76, to a second position proximal the first position, wherein the latch portion80engages the flap portion60of the buckle member58in the “deployed” configuration, as seen inFIGS. 10-11for example. In at least some embodiments, the release pin20may be movable independently of the actuator member50.

However, with the release pin20disposed in the first position, the actuator member50is still connected to the post member76, and it may be possible to urge the actuator member50distally to elongate and/or evert the medical implant14, thereby allowing for repositioning and/or retraction of the medical implant14. When the actuator member50is urged distally, the actuator member50may be translated distally relative to the buckle member58. This distal axial translation of the actuator member50may cause a portion of the elongated rod, extending distally of the delivery system12and through the buckle member58to deflect and or bend radially inward toward the central longitudinal axis as the post member76rotates and pivots relative to the actuator member50from the second orientation to the first orientation.

Axial translation of the release pin20from the first position to the second position proximal the first position pulls the release pin20proximally through the loop of the suture member30and therefore decouples and/or disconnects the actuator member50from the post member76. After the release pin20is translated to the second position, the latch portion80is configured to engage the flap portion60of the buckle member58such that movement of the post member76distally relative to the buckle member58is prevented. Additionally, after the release pin20is translated to the second position, proximal withdrawal of the actuator member50will pull the suture member30through the proximal end and/or the latch portion80of the post member76and away from the post member76and/or the anchor member or braid40and the distal end portion of the actuator member50may contact the collar36, thereby withdrawing the collar36proximally as the actuator member50is withdrawn proximally to permit the fingers34to disengage from the buckle member58, as seen inFIG. 12for example. Similarly, after the release pin20is translated to the second position, the plurality of actuator members50and the fingers34of the coupler32may be withdrawn from the medical implant14thereby leaving the medical implant14(and/or the anchor member or braid40) at the target site or area of interest in a “released” configuration, as seen inFIG. 12for example.

In some embodiments, when the release pin20is in the first position, and the post member76is in the second orientation, the actuator member50is positioned in a generally coaxial, end-to-end arrangement with the post member76. In some embodiments, when the release pin20is in the first position, and the anchor member or braid40would be in the “deployed” configuration except for the release pin20being engaged with the flap portion60of the buckle member58, the actuator member50is positioned in a generally coaxial, end-to-end arrangement with the post member76. In some embodiments, as the release pin20is translated to the second position and the anchor member or braid40is disposed in the “deployed” configuration, the actuator member50is positioned in a generally coaxial, end-to-end arrangement with the post member76. In some embodiments, after the release pin20has been translated to the second position and the anchor member or braid40is disposed in the “deployed” configuration, the actuator member50is positioned in a generally coaxial, end-to-end arrangement with the post member76.

After the release pin20is translated to the second position, further retraction of the actuator member50may cause the distal end portion of the actuator member50to engage the collar36and cause the collar36to slide proximally along the finger34of the coupler32as the actuator member50is retracted proximally. In doing so, a forked end, which has a groove formed therein, of the finger34of the coupler32, is exposed and can be uncoupled from a rail, which has a projection formed thereon that is configured to matingly engage with the groove, on the proximal end of the buckle member58, as shown inFIG. 12. After the forked end has disengaged from the rail, further proximal retraction of the actuator member50causes the finger34of the coupler32to retract proximally from the locking mechanism and the medical implant14, thereby leaving the medical implant14disposed at the target site in the “released” configuration. Lastly, after releasing the medical implant14at the target site, the delivery system12may be re-sheathed, re-stowed, and or otherwise made ready to be removed from the patient's vasculature, and then withdrawn from the vasculature.

The materials that can be used for the various components of the medical implant system10(and/or other systems disclosed herein) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the delivery system12and/or the medical implant14. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the anchor member or braid40, the actuator member50, the post member76, the buckle member58, the release pin20, and/or elements or components thereof.

In some embodiments, an exterior surface of the medical implant system10(including, for example, the exterior surface of the delivery system12) may be sandblasted, beadblasted, sodium bicarbonate-blasted, electropolished, etc. In these as well as in some other embodiments, a coating, for example a lubricious, a hydrophilic, a protective, or other type of coating may be applied over portions or all of the sheath, or in embodiments without a sheath over portion of the delivery system12, or other portions of the medical implant system10. Alternatively, the sheath may comprise a lubricious, hydrophilic, protective, or other type of coating. Hydrophobic coatings such as fluoropolymers provide a dry lubricity which improves device handling and device exchanges. Lubricious coatings improve steerability and improve lesion crossing capability. Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof. Hydrophilic polymers may be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding, and solubility.

The coating and/or sheath may be formed, for example, by coating, extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or fusing several segments end-to-end. The layer may have a uniform stiffness or a gradual reduction in stiffness from the proximal end to the distal end thereof. The gradual reduction in stiffness may be continuous as by ILC or may be stepped as by fusing together separate extruded tubular segments. The outer layer may be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without deviating from the scope of the present invention.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.