Patent Description:
Patients suffering from various medical conditions or diseases may require surgery to install an implantable medical device. For example, valve regurgitation or stenotic calcification of leaflets of a heart valve may be treated with a heart valve replacement procedure. A traditional surgical valve replacement procedure requires a sternotomy and a cardiopulmonary bypass, which creates significant patient trauma and discomfort. Traditional surgical valve procedures may also require extensive recuperation times and may result in life-threatening complications.

One alternative to a traditional surgical valve replacement procedure is delivering implantable medical devices using minimally-invasive techniques. For example, a prosthetic heart valve can be percutaneously and transluminally delivered to an implant location. In such methods, the prosthetic heart valve can be compressed or crimped on a delivery catheter for insertion within a patient's vasculature; advanced to the implant location; and re-expanded to be deployed at the implant location. In this example, a catheter loaded with the prosthetic heart valve in a compressed arrangement can be introduced through an opening in a blood vessel, for example, the femoral artery, aortic artery, or the subclavian artery, and advanced to the heart. At the heart, the prosthetic heart valve can be re-expanded to be deployed at the implant location, e.g., the aortic valve annulus.

In minimally-invasive techniques, it is advantageous to have a small delivery profile for the implantable medical device and delivery system in order to treat a broader range of patient vasculatures. While the profile of the delivery system may be reduced, the given implantable medical device, e.g., a prosthetic heart valve will remain the same size. Accordingly, the reduction in the profile of the delivery system may lead to a higher packing density for the implantable medical device, i.e., the ratio of device volume to available volume. For a prosthetic heart valve, the higher packing density can lead to overlap in the prosthetic heart valve, which is a condition in which portions of the stent or frame of the prosthetic heart valve folds inward in order to fit the reduced space of the delivery system. If this overlap becomes concentrated, the overlap can create elevated crimp strain thereby impacting the structural integrity of the prosthetic heart valve.

<CIT> describes folding patterns and loading funnel for improved transcatheter valve loading forces. <CIT> describes a stent crimping system and method. <CIT> describes systems and methods for loading a valve prosthesis onto a catheter.

The techniques of this disclosure generally relate to loading systems for loading an implantable medical device onto a delivery device and converting the implantable medical device from an expanded (uncompressed) arrangement to a compressed (crimped) arrangement.

The first invention relates to a system for transitioning an implantable medical device from an uncompressed arrangement to a compressed arrangement. The system includes an inflow loading assembly configured to compress an inflow portion of the implantable medical device as the implantable medical device is advanced through the inflow loading assembly. The system also includes an outflow loading assembly removably coupled to the inflow loading assembly. The outflow loading assembly is configured to partially compress an outflow portion of the implantable medical device during coupling to the inflow loading assembly. The inflow loading assembly includes one or more biasing features that are configured to asymmetrically compress the inflow portion of the implantable medical device.

In another aspect of the present disclosure, in combination with any of the other aspects herein, the biasing features comprise one or more ridges formed on an interior surface of the inflow loading assembly.

In another aspect of the present disclosure, in combination with any of the other aspects herein, the biasing features comprise one or more bumps formed on an interior surface of the inflow loading assembly.

According to the first invention,
the inflow loading assembly comprises a first portion and a second portion extending therefrom, and wherein at least one of the first portion or the second portion comprises the one or more biasing features.

In another aspect of the present disclosure, in combination with any of the other aspects herein, the first portion has a constant cross-sectional area.

In another aspect of the present disclosure, in combination with any of the other aspects herein, the first portion and a second portion comprise a common continuous interior surface, the common continuous interior surface having a decreasing diameter from an opening of the second portion to a junction of the second portion and the first portion.

In another aspect of the present disclosure, in combination with any of the other aspects herein, the biasing features comprise one or more ridges formed on an interior surface of the inflow loading assembly that extend from an open end of the first portion to an open end of the second portion.

In another aspect of the present disclosure, in combination with any of the other aspects herein, the biasing features comprise one or more bumps formed on an interior surface of the inflow loading assembly that extend from an open end of the first portion to an open end of the second portion.

According to the first invention,
at least one of the first potion or the second portion is formed having a non-circular cross-section.

In another aspect of the present disclosure, in combination with any of the other aspects herein, the system is a loading system for transitioning an implantable medical device, in particular a prosthetic heart valve, from an uncompressed arrangement to a compressed arrangement.

In another aspect, the present disclosure provides a system for percutaneously delivering a prosthetic heart valve, the prosthetic heart valve being radially self-expandable from a compressed arrangement to an uncompressed arrangement. The system includes a delivery having a distal portion and a proximal control handle portion by which the distal portion is effectively controlled. The system also includes a loading system according to the the first invention. The loading system is configured to transition the prosthetic heart valve from the uncompressed arrangement to the compressed arrangement on the distal portion of the delivery device. The loading system includes an inflow loading assembly configured to compress an inflow portion of the prosthetic heart valve as the prosthetic heart valve is advanced through the inflow loading assembly. The inflow loading assembly includes one or more biasing features that are configured to asymmetrically compress the inflow portion of the implantable medical device. The loading system also includes an outflow loading assembly removably coupled to the inflow loading assembly. The outflow loading assembly is configured to partially compress an outflow portion of the prosthetic heart valve during coupling to the inflow loading assembly.

In another aspect of the present disclosure, in combination with any of the other aspects herein, the system is a percutaneous prosthetic heart valve delivery system.

The second invention relates to a crimper for altering an implantable medical device from an uncompressed arrangement to a compressed arrangement. The crimper includes a crimper housing that includes a plurality of crimper elements. The plurality of crimper elements defines a crimper channel. The plurality of crimper elements includes one or more biasing features that are configured to asymmetrically compress the implantable medical device. The crimper also includes handle configured to operate the crimper elements. The movement of the handle displaces the plurality of crimper elements. The displacement of the plurality of crimper elements decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed arrangement to the compressed arrangement.

In another aspect of the second invention,
the biasing features comprise one or more ridges formed on an interior surface of the plurality of crimper elements.

In another aspect of the second invention,
the biasing features comprise one or more bumps formed on an interior surface of the plurality of crimper elements.

In an example, the present disclosure provides an illustrative method (not claimed) for altering an implantable medical device from an uncompressed arrangement to a compressed arrangement. The illustrative method includes loading a first end of the implantable medical device include a loading system. The loading system includes an inflow loading assembly and an outflow loading assembly and at least one of the inflow loading assembly and the outflow loading assembly includes one or more one or more biasing features that are configured to asymmetrically compress the first end of the implantable medical device. The illustrative method also includes advancing the first end of the implantable medical device into the loading system. A volume of the inflow loading assembly or the outflow loading assembly asymmetrically transitions the first end of the implantable medical device from the uncompressed arrangement to the compressed arrangement.

In an example, the present disclosure provides an illustrative method (not claimed) for altering an implantable medical device from an uncompressed arrangement to a compressed arrangement. The illustrative method includes loading the implantable medical device into a crimper chamber of a crimper. The method further includes actuating a handle of the crimper. The actuation of the handle decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed arrangement to the compressed arrangement. The crimper chamber includes one or more biasing features that are configured to asymmetrically compress the implantable medical device.

The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the present disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure.

Specific embodiments of the present disclosure are now described with reference to the figures. The following detailed description describes examples of embodiments and is not intended to limit the present technology or the application and uses of the present technology. Although the description of embodiments hereof is in the context of a loading device, the present technology may also be used in other devices.

The terms "distal" and "proximal", when used in the following description to refer to a delivery system or catheter are with respect to a position or direction relative to the treating clinician. Thus, "distal" and "distally" refer to positions distant from, or in a direction away from the treating clinician, and the terms "proximal" and "proximally" refer to positions near, or in a direction toward the clinician.

Embodiments disclosed herein are directed to a loading system for loading an implantable medical device into or onto a delivery device and converting the implantable medical device from an uncompressed (expanded) arrangement to a compressed arrangement. The loading system includes one or more loading assemblies (e.g., inflow loading assemblies and/or outflow loading assemblies) that compress the implantable medical device into a non-circular shape. The loading assemblies induce specific shapes or patterns in structural components of the implantable medical device during loading. These shapes disperse the overlap of the structural components of the implantable medical device into several predetermined locations, reducing the global maximum strain on the structural components of the implantable medical device. As such, the loading system enables implantable medical devices to be loaded into smaller profile delivery systems, without compromising performance of the implantable medical devices. This may allow for an implantable medical device, such as a prosthetic heart valve, to maintain its performance in key areas such as paravalvular leakage, migration resistances, hemodynamics, durability, etc..

<FIG> illustrate an example of a loading system <NUM> in accordance with an embodiment hereof. One skilled in the art will realize that <FIG> illustrate one example of a loading system and that existing components illustrated in <FIG> may be removed and/or additional components may be added to the loading system <NUM>.

As disclosed herein, the loading system <NUM> can be utilized on implantable medical devices (e.g., prosthetic heart valves) that are to be delivered transluminally via portions of a delivery system, e.g., via a catheter, and that need to be loaded onto or into the portions of a delivery system. The loading system <NUM> can be utilized to radially compress components of the implantable medical device (e.g., stent or frame of a prosthetic heart valve) to have a small profile, e.g., until a diameter of the implantable medical device is as close to the portions of the delivery system as possible. Likewise, during the compression process, the loading system <NUM> can be utilized to load the implantable medical device (e.g., prosthetic heart valves) into/onto portions of a delivery system such that the implantable medical device can be delivered through the vessels to an implant location in a compressed arrangement, and then expanded at the implant location, for example, by a self-expanding stent/frame or a balloon of the delivery system to replace the native heart valve.

As illustrated in <FIG>, the loading system <NUM> includes an inflow loading assembly <NUM>, an outflow loading assembly <NUM>, a backplate <NUM>, a tip guide tube <NUM>, and a capsule guide <NUM>. The inflow loading assembly <NUM>, the outflow loading assembly <NUM>, the backplate <NUM>, the tip guide tube <NUM>, and the capsule guide <NUM> are configured to operate together to transition an implantable medical device (e.g., prosthetic heart valve) from an uncompressed arrangement to a compressed arrangement. In particular, the inflow loading assembly <NUM> and the outflow loading assembly <NUM> includes one or more tapered chambers and/or one or more reduced diameter chambers that apply a compression force on external surfaces of the implantable medical device when introduced to the loading system <NUM>. While transitioning the implantable medical device, the inflow loading assembly <NUM>, the outflow loading assembly <NUM>, the backplate <NUM>, the tip guide tube <NUM>, and the capsule guide <NUM> are configured to operate together to load the implantable medical device into/onto a delivery system.

Conventional loading systems are typically designed such that the portions of the loading system, which compress the implantable medical device, have a circular cross-section. For example, a conventional loading system may include one or more conical funnels and/or tubes with circular cross-sections that uniformly reduce in diameter to compress the implantable medical device, as illustrated in <FIG>, which is a cross-sectional view of a portion of a conventional loading system <NUM>. As illustrated in <FIG>, in the case of the loading system <NUM> with uniform circular reduction in diameter, uniform force is applied to an exterior surface of the implantable medical device. As such, structural components <NUM> of the implantable medical device (e.g., struts and crowns of a prosthetic heart valve) are compressed symmetrically. The symmetrical compression may cause pressure to build in random locations as all of the structural components <NUM> of the implantable medical device try to conform to a tight circular shape. The pressure build-up is typically released, unpredictably, by one or more structural components <NUM> buckling and filling a free space <NUM> inside the rest of the structural components <NUM>. As illustrated in <FIG>, the buckling may cause a concentration <NUM> of the structural components <NUM> to form within the free space <NUM> at an unpredictable location or unpredictable locations. The concentration <NUM> of the structural components <NUM> can create elevated crimp strain thereby impacting the structural integrity of the implantable medical device and may produce damage to components of the implantable medical device (e.g., valve leaflets in a prosthetic heart valve.

In embodiments, to address these drawbacks and allow loading in low profile delivery systems, the inflow loading assembly <NUM> and/or the outflow loading assembly <NUM> are designed to bias select portions of the implantable medical device towards a central axis of the implantable medical device. In some embodiments, the inflow loading assembly <NUM> and/or the outflow loading assembly <NUM> include one or more portions that have a non-circular cross-sections to compress the implantable medical device, as described below in further detail. In some embodiments, the inflow loading assembly <NUM> and/or the outflow loading assembly <NUM> include one or more biasing features <NUM> that apply a compression force, unevenly, to the exterior surfaces of the implantable medical device, as illustrated in <FIG> and discussed below in further detail. The biasing features <NUM> are designed to cause overlap of the structural components <NUM> of the implantable medical device at multiple and select locations. As such, the biasing features <NUM> distribute the overlap of the structural components evenly within the free space <NUM> of the implantable medical device, thereby reducing the occurrence of a concentration of the structural components of the implantable medical device. The distributed overlap may allow for safe loading the implantable medical device into lower profile delivery systems. For example, as illustrated in <FIG>, in the case of a non-uniform loading system, the structural components <NUM> are compressed asymmetrically. This prevents circumferential pressure build-up by biasing the structural components inwards in predefined areas. This gives predictability in where an overlap <NUM> of the structural components may occur.

Returning to <FIG>, in embodiments, the outflow loading assembly <NUM> is configured to couple with the inflow loading assembly <NUM>. The inflow loading assembly <NUM> is configured to hold the implantable medical device such that one end of the implantable medical device, e.g., an outflow portion of a prosthetic heart valve, can be compressed by the outflow loading assembly <NUM> and the capsule guide <NUM>. Additionally, or alternatively, the inflow loading assembly <NUM> is configured to crimp the other end of the medical device, e.g., an inflow portion of a prosthetic heart valve, and to hold the medical device at a compressed arrangement until the implantable medical device is loaded into/onto the delivery device. One example of the inflow loading assembly <NUM> is described in further detail below with reference to <FIG>. Additionally, another example of the inflow loading assembly <NUM> is described in further detail below with reference to <FIG> and <FIG>.

In embodiments, the outflow loading assembly <NUM> is configured to partially compress one end of implantable medical device, for example, an outflow end of a prosthetic heart valve. Additionally, or alternatively, the outflow loading assembly <NUM> is configured to operate in combination with the capsule guide <NUM> to compress one end of the implantable medical device and load the implantable medical device onto the delivery system. One example of the outflow loading assembly <NUM> is described in further detail below with reference to <FIG> and <FIG>.

In embodiments, the capsule guide <NUM> is configured to provide additional column support for protecting a distal portion of a delivery device, for example, a capsule of a delivery catheter, during loading. Additionally, or alternatively, the capsule guide <NUM> is configured to notify a user of a potential misload. The capsule guide <NUM> may also be configured to interface the coupling members of an implantable medical device, for example, paddles of a prosthetic heart valve, with the coupling members of the attachment member of the delivery device, for example, recesses in a spindle of a delivery catheter. The capsule guide <NUM> may be also configured to allow for inspection by a user that correct coupling has occurred, for example, that the paddles are correctly seated within the recess. One example of the capsule guide <NUM> is described in further detail below with reference to <FIG>.

In embodiments, the tip guide tube <NUM> is configured to allow a tip of a delivery device to pass atraumatically through the implantable medical device and to spread open one end of the medical device, e.g., the outflow end of a prosthetic heart valve including outflow crowns and paddles, to align the coupling members of the implantable medical device with the coupling members of the attachment member of the delivery device as described below. One example of the tip guide tube <NUM> is described in further detail below with reference to <FIG>.

In some embodiments, at least one portion of one or more components of the loading system <NUM> can be transparent. For example, the inflow loading assembly <NUM>, the outflow loading assembly <NUM>, the backplate <NUM>, the tip guide tube <NUM>, and the capsule guide <NUM> can each be transparent. This transparency allows a user to visually verify the proper orientation and coupling of an implantable medical device being loaded as further described below. Components of the loading system can made of any suitable material or materials. For example, the inflow loading assembly <NUM>, the outflow loading assembly <NUM>, the backplate <NUM>, the tip guide tube <NUM>, and the capsule guide <NUM> can be made of materials commonly used in medical device applications such as suitable polymeric materials, metals, and the like.

The loading system <NUM> is configured to convert an implantable medical device from its uncompressed arrangement to its compressed arrangement and to load the implantable medical device into/onto portions of a delivery system, as described below in further detail with reference to <FIG> and <FIG>. One example of a delivery system is described in further detail below with reference to <FIG> and <FIG>. One example of implantable medical device is described in further detail below with reference to <FIG> and <FIG>.

<FIG> illustrate an example of the inflow loading assembly <NUM> in accordance with an embodiment hereof. One skilled in the art will realize that <FIG> illustrate one example of an inflow loading assembly and that existing components illustrated in <FIG> may be removed and/or additional components may be added to the inflow loading assembly <NUM>.

As illustrated in <FIG> and <FIG>, which are perspective views of the inflow loading assembly <NUM> and <FIG>, which is a side view, the inflow loading assembly <NUM> includes a distal end <NUM> and a proximal end <NUM>. The inflow loading assembly <NUM>
includes a first potion <NUM> and a second portion <NUM>. As illustrated in <FIG> and <FIG>, which are axial views of the distal end <NUM> and the proximal end <NUM>, respectively, the inflow loading assembly <NUM> may define a channel <NUM> extending from the distal end <NUM> to the proximal end <NUM>, thereby forming a distal opening <NUM> and a proximal opening <NUM>, respectively. The channel <NUM> of the inflow loading assembly <NUM> may be configured to receive and to compress or partially compress one end of an implantable medical device. In some embodiments, as described below, the configuration of the channel reduces potential damage to the implantable medical device during compression. When the inflow loading assembly <NUM> is coupled to the outflow loading assembly <NUM>, the channel <NUM> extending from the distal end <NUM> to the proximal end <NUM> is coaxial with a channel extending from respective ends of the outflow loading assembly <NUM> (e.g., ends <NUM>, <NUM>, and channel <NUM> described below with reference to <FIG> and <FIG>). An inner dimension (e.g., cross-sectional area) of the proximal opening <NUM> is larger than an inner dimension (e.g., cross-sectional area) of the distal opening <NUM>.

The second portion <NUM>, including the proximal opening <NUM>, is configured to secure, to guide, and to position one end of an implantable medical device, e.g., an inflow end of a prosthetic heart valve, by an interference fit as described below referring to <FIG> and <FIG>. For example, beginning at the proximal opening <NUM> at the proximal end <NUM>, the second portion <NUM> can have a tapered or modified geometry that operates to compress a portion of the implantable medical device when advanced from the proximal opening <NUM> into the second portion <NUM>. In embodiments, the second portion <NUM> of the inflow loading assembly <NUM> is configured to compress one end of an implantable medical device, for example, the inflow portion of a prosthetic heart valve, as the implantable medical device slides against an inner surface <NUM> of the second portion <NUM>. The inner surface <NUM> decreases in internal diameter in a direction from the proximal end <NUM> to the distal end <NUM>. In some embodiments, the second portion <NUM> can be formed having a frustoconical inner surface. In some embodiments, the second portion <NUM> has a curved or stepped inner surface that tapers. Furthermore, although the inner surface <NUM> of the second portion <NUM> of the inflow loading assembly <NUM> is generally circular in cross-sectional shape as shown in <FIG>, other suitable shapes may be employed, as described below in further detail with reference to <FIG> and <FIG>. Additionally, although an outer surface of the second portion <NUM> has a shape that generally corresponds to the inner surface <NUM> of the second portion <NUM> in <FIG> and <FIG>, in some embodiments, the outer surface can be formed in a shape that differs from the inner surface <NUM> of the second portion <NUM> and can have any suitable shape.

While <FIG> illustrate the second portion <NUM> having a circular cross-section, the second portion <NUM> can be formed to have any non-circular cross-section that provides a non-uniform compression force. For example, the second portion <NUM> can be formed in a regular three-dimensional shape, such as a hollow geometric prism with four or more sides. Likewise, for example, the second portion <NUM> can be formed in an irregular three-dimensional shape.

The second portion <NUM> of the inflow loading assembly <NUM> also defines a slot <NUM> in communication with the channel <NUM> extending between the distal end <NUM> and the proximal end <NUM>. The slot <NUM> may be positioned at the proximal end <NUM> and configured to slidably receive the backplate <NUM>. In embodiments, the slot <NUM> can be defined by the tabs <NUM> positioned at opposing sides of the proximal opening <NUM>. A size and shape of slot <NUM> substantially corresponds to a cross-sectional shape of backplate <NUM>. For example, as shown in <FIG>, the slot <NUM> can be approximately rectangular, which corresponds to the rectangular cross-sectional shape of the backplate <NUM>, and can include one or more stops <NUM> for positioning the backplate <NUM>. In embodiments, the backplate <NUM> can operate as a stop for one end of the implantable medical device. The second portion <NUM> also includes tabs <NUM> that define engagement slots <NUM>. The tabs <NUM> are configured to engage with engagement tabs of the outflow loading assembly <NUM>, described below with reference to <FIG> and <FIG>. That is, the engagement tabs of the outflow loading assembly <NUM> are aligned with the tabs <NUM> of the inflow loading assembly <NUM>, and the outflow loading assembly <NUM> is advanced until the engagement tabs of the outflow loading assembly <NUM> enter the engagement slots <NUM> and engage the tabs <NUM>. In some embodiments, the tabs <NUM> can include one or more pins <NUM> that can engage with the outflow loading assembly <NUM>.

The first portion <NUM> of the inflow loading assembly <NUM> is configured to hold an implantable medical device at a compressed arrangement until the implantable medical device is loaded on a delivery device, for example, within a capsule of a delivery catheter. In some embodiments, the first portion <NUM> has an inner surface <NUM> having a circular cross-section. In some embodiments, as illustrated in <FIG> and discussed below in further detail, the first portion <NUM> can have a non-cylindrical inner surface <NUM> having a non-circular cross-section. In some embodiments, the first portion <NUM> can have a tapered inner surface that reduces in diameter.

As illustrated in <FIG>, the first portion <NUM> is adjacent and distal to the second portion <NUM> and are coupled at a junction <NUM>. In some embodiments, an inner dimension (e.g., cross-sectional surface area) of the first portion <NUM> is smaller than an inner dimension (e.g., cross-sectional surface area) of the junction <NUM> of the second portion <NUM> and the first portion <NUM>. In some embodiments, an inner dimension of the first portion <NUM> is sized such that the tip guide tube <NUM> can pass through an implantable medical device compressed and loaded within the first portion <NUM> and such that the implantable medical device is compressed as much as possible before being loaded within a portion of a delivery system, e.g., withdrawn into a delivery portion of a catheter. In some embodiments, an axial length of the first portion <NUM> is substantially equal to or greater than an axial length of the medical device. In some embodiments, the first portion <NUM> is separate from the second portion <NUM> and the first portion <NUM> is coupled to the second portion <NUM>, for example, by ultrasonic welding or a snap fit. In some embodiments, the first portion <NUM> is integral with the second portion <NUM>.

As illustrated in <FIG> and <FIG>, the inner surface <NUM> of the first portion <NUM> can be formed to have an approximate triangular shape formed by sidewalls <NUM> coupled at corners <NUM>, thereby defining the distal opening <NUM> with an approximately triangular shape. That is, the portion of the channel <NUM> formed by the first portion <NUM> can be formed in the three-dimensional shape of a hollow geometric prism with three sides. The triangular cross-sectional shape of the inner surface <NUM> of the first portion <NUM> is configured to provide an asymmetric compression force on the outer surfaces of the implantable medical device. For example, the implantable medical device may generally have a tubular shape with a circular or elliptical cross-section, for example, as illustrated in <FIG> and <FIG>. Accordingly, when the tubular-shaped implantable medical device is introduced to the portion of the channel <NUM> formed by the first portion <NUM>, the triangular cross-sectional shape of the inner surface <NUM> of the first portion <NUM> provides a compression force that is non-uniform on the exterior surfaces of the tubular-shaped implantable medical device, as discussed above with reference to <FIG>. Although an outer surface of the first portion <NUM> has a shape that generally corresponds to the inner surface <NUM> of the first portion <NUM> in <FIG>, <FIG>, and <FIG>, in some embodiments, the outer surface can be formed in a shape that differs from the inner surface <NUM> of the first portion <NUM> and can have any suitable shape.

While <FIG> illustrate the first portion <NUM> having a triangular cross-section, the first portion <NUM> can be formed to have any non-circular cross-section that provides a non-uniform compression force. For example, the first portion <NUM> can be formed in a regular three-dimensional shape, such as a hollow geometric prism with four or more sides. Likewise, for example, the first portion <NUM> can be formed in an irregular three-dimensional shape.

In embodiments, the proximal opening <NUM> is formed in an approximate equilateral triangular cross-section formed by sidewalls <NUM> that are coupled at corners <NUM>. Each sidewall <NUM> can be formed to a length, d<NUM>. The sidewalls <NUM> are formed with the length, d<NUM> so that the tip guide tube <NUM> can pass through an implantable medical device compressed and loaded within the first portion <NUM> and such that the implantable medical device is compressed as much as possible before being loaded with a portion of a delivery system, e.g., withdrawn into a delivery portion of a catheter. In embodiments, the length, d<NUM>, of the sidewalls <NUM> may depend on the French (FR) size of the catheter or the size of the implantable medical device. For example, the length, d<NUM>, of the sidewalls <NUM> may be formed to accommodate a <NUM>-<NUM> Fr catheter and/or a <NUM>-<NUM> implantable medical device.

As illustrated in <FIG> and <FIG>, the proximal opening <NUM> of the second portion <NUM> can be formed having a diameter, f<NUM>. The junction <NUM> of the first portion <NUM> and the second portion <NUM> can be formed having a diameter, f<NUM>. The inner surface 230of the second portion <NUM> forms a compression chamber defined by the decreasing diameter of the second portion <NUM> from the proximal opening <NUM> (the diameter,f<NUM>) and to the junction <NUM> (the diameter, f<NUM>). In some embodiments, the decreasing diameter of the compression chamber of the second portion <NUM> can be formed in an approximate funnel or cone shape. In embodiments, a rate or degree at which the diameter decreases from the proximal opening <NUM> to the junction <NUM>, e.g., slope, can affect the angle at which the implant attachment tabs exit the second portion <NUM>, with a longer taper improving the loading of an implantable medical device. The longer taper may provide a smoother transition for the implantable medical device during loading into the delivery device. In embodiments, the diameter decreases from the proximal opening <NUM> to the junction <NUM> and operates to apply a compression force on the implantable medical device as the implantable medical device is moved through the compression volume. In embodiments, the diameter, f<NUM> at the junction <NUM> of the second portion <NUM> and the first portion <NUM> may depend on the FR size of the catheter. For example, the diameter, f<NUM>, of the second portion <NUM> may be formed to accommodate a <NUM>-<NUM> Fr catheter. In embodiments, the diameter, f<NUM>, of the proximal opening <NUM> of the second portion <NUM> may depend on an outer diameter of the implantable medical device.

In embodiments, as illustrated in <FIG>, the first portion <NUM> and the second portion <NUM> can be formed having different cross-sectional shapes thereby defining the channel <NUM> having a different shape for the first portion <NUM> and a different shape for the second portion <NUM>. That is, the first portion <NUM> can have a triangular cross-section and the second portion <NUM> can have a circular cross-section.

Interior surfaces of the inflow loading assembly <NUM> include one or more biasing features that provide an asymmetric compression force. For example, as illustrated in <FIG> and <FIG>, the channel <NUM> can include three biasing features <NUM>. Each of the biasing features <NUM> can be formed as a rectangular ridge that extends on the inner surfaces of the first portion <NUM> and the second portion <NUM> from the distal opening <NUM> to the proximal opening <NUM>. In embodiments, when formed as a rectangular ridge, each of the biasing features <NUM> can be formed to any dimensions, e.g., width, depth, length, in order to provide an asymmetric compression force on the implantable medical device. In some embodiments, a width of a biasing feature <NUM> can range from approximately <NUM> millimeter (mm) to approximately <NUM>. In some embodiments, a length of a biasing feature <NUM> can range from approximately <NUM> to approximately <NUM>. In some embodiments, the dimensions of the biasing features <NUM> can be constant. In some embodiments, the dimensions of the biasing features <NUM> can vary. For example, the width and/or the depth of biasing features <NUM> can increase and/or decrease along the length of the biasing features <NUM>. That is, each of the biasing features <NUM> may have a larger width and/or the depth at the proximal opening <NUM> as compared to the distal opening <NUM>, or vice versa. While <FIG> illustrate biasing feature <NUM> as being rectangular ridge, one skilled in the art will realize that a biasing feature can be formed in any shape and/or size.

In embodiments, as illustrated in <FIG>, the biasing features <NUM> can be formed on interior surfaces of the first portion <NUM> and the second portion <NUM>. Likewise, in some embodiments, the biasing features <NUM> can be formed on only the interior surfaces the first portion <NUM> or the interior surfaces of the second portion <NUM>.

<FIG> and <FIG> illustrate simplified views of another example of the inflow loading assembly <NUM>. As illustrated in <FIG>, which is a side view, the inflow loading assembly <NUM> includes a distal end <NUM> and a proximal end <NUM>. The inflow loading assembly <NUM> includes a first portion <NUM> and a second portion <NUM>. As illustrated in <FIG>, which is a view of the proximal end <NUM>, the first portion <NUM> and the second portion <NUM> define a channel <NUM> that extends from a proximal opening <NUM> to a distal opening <NUM>. As illustrated, the first portion <NUM> and the second portion <NUM> can be formed having a same cross-sectional shape, e.g., a hollow geometric prism with three sides. For example, the first portion <NUM> and the second portion <NUM> can have an approximate triangular shape formed by the inner surface <NUM> of the first portion <NUM> and the inner surface <NUM> of the second portion <NUM>, thereby defining the distal opening <NUM> and the proximal opening <NUM> with an approximate triangular shape. The triangular cross-sectional shape of inner surfaces of the first portion <NUM> and the second portion <NUM> are configured to provide an asymmetric compression force on the outer surfaces of the implantable medical device.

In embodiments, as illustrated in <FIG> and <FIG>, the biasing features <NUM> can be formed as semi-circular bumps. The semi-circular bumps can be formed on the inner surface <NUM> of the first portion <NUM> and the inner surface <NUM> of the second portion <NUM>. In embodiments, when formed as semi-circular bumps, each of the biasing features <NUM> can be formed to any dimensions, e.g., radius, in order to provide an asymmetric compression force on the implantable medical device. In some embodiments, a radius of a biasing feature <NUM> can range from approximately <NUM> to approximately <NUM>. In some embodiments, the biasing features <NUM> can be formed as oval shaped bumps. In this embodiment, a width of the oval shape can range from approximately <NUM> to approximately <NUM>, and a length of the oval shape can range from approximately <NUM> to approximately <NUM>. In some embodiments, the dimensions of the biasing features <NUM> can be constant. In some embodiments, the dimensions of the biasing features <NUM> can vary. For example, the radius of biasing features <NUM> can increase and/or decrease along the length of the inflow loading assembly <NUM>. That is, each of the biasing features <NUM> may have a larger radius at the proximal opening <NUM> as compared to the distal opening <NUM>, or vice versa. While <FIG> and <FIG> illustrate biasing feature <NUM> as being discrete semi-circular bumps, one skilled in the art will realize that a biasing feature can be formed in any shape and/or size.

In embodiments, the biasing features <NUM>, as illustrated in <FIG> and <FIG>, can be formed on the inner surface <NUM> of the first portion <NUM> and/or the inner surface <NUM> the second portion <NUM>. Likewise, in some embodiments, the biasing features <NUM> can be formed on only the interior surfaces the first portion <NUM> or the inner surface <NUM> of the second portion <NUM>, as illustrated <FIG>. Likewise, while <FIG> and <FIG> illustrate the inflow loading assembly <NUM> including nine (<NUM>) biasing features <NUM>, three (<NUM>) on each side channel <NUM> in the second portion <NUM>, one skilled in the art will realize that the inflow loading assembly <NUM> can include any number of biasing features <NUM>.

Further, as illustrated in <FIG> and <FIG>, the first portion <NUM> and the second portion <NUM> can be formed having a same cross-sectional shape, e.g., a triangular shape. While <FIG> and <FIG> illustrate the first portion <NUM> and the second portion <NUM> having a triangular cross-section, the first portion <NUM> and the second portion <NUM> can be formed to have any non-circular cross-section that provides an asymmetric compression force. For example, the first portion <NUM> and the second portion <NUM> can be formed in a regular three-dimensional shape, such as a hollow geometric prism with four or more sides. Likewise, for example, the first portion <NUM> can be formed in an irregular three-dimensional shape.

<FIG> and <FIG> illustrate an example of the outflow loading assembly <NUM> in accordance with an embodiment hereof. One skilled in the art will realize that <FIG> and <FIG> illustrate one example of an outflow loading assembly and that existing components illustrated in <FIG> and <FIG> may be removed and/or additional components may be added to the outflow loading assembly <NUM>.

As illustrated in <FIG>, which is a perspective view, the outflow loading assembly <NUM> defines a channel <NUM> extending from a distal open end <NUM> to a proximal open end <NUM>. The outflow loading assembly <NUM> may include a portion <NUM> having a tapered inner surface <NUM> that has an inner dimension that decreases, as illustrated in <FIG>, which is a view from the distal open end <NUM>. In some embodiments, the tapered inner surface <NUM> continuously decreases, from the distal open end <NUM> to the proximal open end <NUM>. In embodiments, the inner dimension (e.g., cross-sectional area) of the proximal open end <NUM> is smaller than the inner dimension (e.g., cross-sectional area) of the distal open end <NUM>. The inner dimension of the proximal open end <NUM> is preferably sized to allow the capsule guide <NUM> to pass therethrough. The inner dimension of the distal open end <NUM> is preferably sized to receive an end of the implantable medical device, for example, an outflow end of a prosthetic heart valve, and compress the end the implantable medical device as the outflow loading assembly <NUM> is moved towards the inflow loading assembly <NUM>. The inner dimension of the distal open end <NUM> is preferably sufficient to encompass the end of the implantable medical device without damaging the implantable medical device. The angle of the tapered surface relative <NUM> to the longitudinal axis of the outflow loading assembly <NUM>, the inner diameter of the proximal open end <NUM>, and the length between the portion <NUM> and the proximal open end <NUM> may vary dependent on the size or design of the medical device to ensure a consistent interface with the delivery system.

In some embodiments, the portion <NUM> has a frustoconical inner surface. In some embodiments, the portion <NUM> has a curved or stepped inner surface that tapers. Furthermore, although the portion <NUM> of the outflow loading assembly <NUM> is generally circular in cross-section, other suitable shapes that load the medical device without damage may be employed. Additionally, although the outer surface of the portion <NUM> has a shape that generally corresponds to the inner surface of the portion <NUM>, as in <FIG> and <FIG>, in some embodiments, the outer surface does not corresponded to the tapered inner surface of the portion <NUM>.

The outflow loading assembly <NUM> is configured to couple with the inflow loading assembly <NUM>. For example, in some embodiments, the outflow loading assembly <NUM> includes one or more engagement tabs <NUM> configured to selectively couple to the inflow loading assembly <NUM>, for example, by coupling to respective tabs <NUM> defined by outflow loading assembly <NUM>, as described above with reference to <FIG>. As shown in <FIG>, the outflow loading assembly <NUM> can include an opposing pair of the engagement tabs <NUM> extending in a distal direction from the distal open end <NUM>. In some embodiments, the outflow loading assembly <NUM> can include one tab <NUM> or more than two tabs <NUM>.

The outflow loading assembly <NUM> can be ergonomically designed to facilitate easy handling by a user. For example, as shown in <FIG>, the outflow loading assembly <NUM> can include one or more gripping tabs <NUM>. The gripping tabs <NUM> protrude from the exterior surface of the portion <NUM>. A user can easily place a thumb and index finger on the gripping tabs <NUM> to handle the outflow loading assembly <NUM>.

<FIG> illustrate an example of the capsule guide <NUM> in accordance with an embodiment hereof. One skilled in the art will realize that <FIG> illustrate one example of a capsule guide and that existing components illustrated in <FIG> may be removed and/or additional components may be added to the capsule guide <NUM>.

As illustrated in <FIG>, which is a side view, the capsule guide <NUM> includes a main body portion <NUM> having a distal open end <NUM> and a proximal open end <NUM>. As illustrated in <FIG>, which is an axial view of the distal open end <NUM>, the main body portion <NUM> preferably defines a channel having a distal open end <NUM> and a proximal open end <NUM>. In some embodiments, the main body portion <NUM> has a substantially cylindrical outer surface. The main body portion <NUM> can protect a delivery portion (e.g., capsule) of the delivery device by reducing or preventing the capsule from excessively bowing or being pinched by the user via additional column support. The capsule guide <NUM> can also comprise a tip <NUM>. In some embodiments, the tip <NUM> can be elastomeric. In some embodiments, the tip <NUM> has a tapered outer surface, where an outer dimension of the tip <NUM> decrease in a direction from the proximal open end <NUM> to the distal open end <NUM>. The outer dimension of main body portion <NUM> and tip <NUM> is preferably smaller than an inner dimension of the distal open end <NUM> and the proximal open end <NUM> of the outflow loading assembly <NUM>, and/or smaller than an inner dimension of the proximal end <NUM> and the second portion <NUM> of the inflow loading assembly <NUM>, so the main body portion <NUM> and the tip <NUM> can preferably pass into the channel collectively defined by the outflow loading assembly <NUM> and the inflow loading assembly <NUM>. In some embodiments, an inner dimension of the tip <NUM> is smaller than an outer dimension of a tip of a delivery device.

The exterior surface of the main body portion <NUM> defines an exterior shoulder <NUM> that extends radially outward at the distal open end <NUM>. As illustrated in <FIG>, the interior surface of the main body portion <NUM> may define an interior shoulder <NUM> that extends radially inward adjacent to the tip <NUM>. The interior shoulder <NUM> can be sized to prevent a capsule of a delivery device from distally advancing past the interior shoulder <NUM> and through distal open end <NUM> and into tip <NUM>. In some embodiments, a portion of main body portion <NUM> adjacent and proximal to interior shoulder <NUM> is configured to prevent the capsule of a delivery system from expanding during loading. In some embodiments, this portion of main body portion <NUM> adjacent interior shoulder <NUM> is a tight tolerance area that provides a tight fit with the capsule of the delivery system and/or substantially prevents the capsule from expanding during loading. In some embodiments, the inner dimension of a portion of main body portion <NUM> adjacent interior shoulder <NUM> is sized such that if there is a misload between the delivery catheter and the medical device, a noticeable increase in the amount of force required to load the medical device within the capsule will occur because the outer dimension of the medical device will be larger than the inner dimension of the portion of main body portion <NUM> adjacent interior shoulder <NUM>.

The capsule guide <NUM> can include, in some embodiments, a handle portion <NUM>. The handle portion <NUM> can be ergonomically designed to facilitate easy handling of the capsule guide <NUM>. In some embodiments, the handle portion <NUM> extends radially outward from the main body portion <NUM>. For example, as shown in <FIG>, the handle portion <NUM> can have a shape that allows handling by a user. The main body portion <NUM> can have an axial length such that when the handle portion <NUM> abuts proximal open end <NUM> of the outflow loading assembly <NUM>, the open end <NUM> is adjacent a proximal end <NUM> of the first portion <NUM> of the inflow loading assembly <NUM>.

In some embodiments, the handle portion <NUM> has an outside diameter that is larger than an inside diameter of the proximal open end <NUM> of the outflow loading assembly <NUM>. In such embodiments, the handle portion <NUM> can function as a stop preventing further distal movement of the capsule guide <NUM> relative to the outflow loading assembly <NUM>. The capsule guide <NUM> can include a locking collar <NUM> slidably coupled to the exterior surface of the main body portion <NUM>. The locking collar <NUM> is preferably configured to slide axially from the handle <NUM> to the tip <NUM>. In some embodiments, as illustrated in <FIG>, the locking collar <NUM> can be ergonomically designed to facilitate easy sliding of the locking collar <NUM>. In some embodiments, the main body portion <NUM> can be formed as separate halves. In this embodiment, the locking collar <NUM> can compress the two halves of the capsule guide <NUM> together. The compression of the capsule guide <NUM> can form a ring that limits a flare of the delivery system from expanding. Additionally, or alternatively, the compression of the locking collar <NUM> can protect components the delivery system and/or the capsule guide <NUM> from damage as the prosthetic heart valve <NUM> is being loaded. As such, the locking collar <NUM> can cause the capsule guide <NUM> and a flexible capsule to operate as rigid objects, while the locking collar <NUM> is engaged.

As illustrated in <FIG> and <FIG>, the main body portion <NUM> can include a substantially cylindrical inner surface that defines a channel <NUM> having a circular cross-section. In other embodiments, as illustrated in <FIG>, the main body portion <NUM> can include a substantially triangular inner surface that defines the channel <NUM> having a triangular cross-section. For example, the cross-sectional shape of the channel <NUM> can match the cross-section shape of the first portion <NUM> and/or the section portion <NUM> of the inflow loading assembly.

<FIG> illustrates an example of the tip guide tube <NUM> in accordance with an embodiment hereof. One skilled in the art will realize that <FIG> illustrates one example of a tip guide tube and that existing components illustrated in <FIG> may be removed and/or additional components may be added to the tip guide tube <NUM>.

The tip guide tube <NUM> can include a main body portion <NUM>. The main body portion <NUM> preferably isolates and protects an implantable medical device, for example, the valve material of a prosthetic valve, from a delivery system passing through the implantable medical device. The main body portion <NUM> may define a channel having an open end <NUM>. In some embodiments, the main body portion <NUM> has a substantially cylindrical outer surface. An outer diameter of the main body portion <NUM> is smaller than an inner dimension of distal open end <NUM> and second proximal open end <NUM> of the outflow loading assembly <NUM>, and/or smaller than an inner dimension of the proximal end <NUM> and the distal end <NUM> of the inflow the inflow loading assembly <NUM>, so the main body portion <NUM> can preferably pass through the channel collectively defined by the outflow loading assembly <NUM> and the inflow the inflow loading assembly <NUM> (and a slot defined by the backplate <NUM>).

The tip guide tube <NUM> can include, in some embodiments, a handle portion <NUM>. The handle portion <NUM> can be ergonomically designed to facilitate easy handling by a user. For example, as shown in <FIG>, the handle portion <NUM> can have a substantially flat paddle shape. The main body portion <NUM> has an axial length such that, when the outflow loading assembly <NUM> is coupled to the inflow loading assembly <NUM> and the main body portion <NUM> passes through the channel collectively defined by the outflow loading assembly <NUM> and the inflow loading assembly <NUM>, the open end <NUM> extends beyond the proximal open end <NUM> of the outflow loading assembly <NUM> and/or the handle portion <NUM> extends beyond the distal end <NUM> of the inflow loading assembly <NUM>.

In some embodiments, the handle portion <NUM> has an outer dimension that is larger than an inner dimension of the distal end <NUM>. In such embodiments, the handle portion <NUM> can function as a stop preventing further proximal movement of the tip guide tube <NUM> relative to the inflow loading assembly <NUM>. In some embodiments, when the handle portion <NUM> abuts the distal end <NUM> of the inflow loading assembly <NUM>, the open end <NUM> of the tip guide tube <NUM> extends beyond the second proximal open end <NUM> of the outflow loading assembly <NUM>. In some embodiments, the main body portion <NUM> has an axial length such that, when the handle portion <NUM> abuts the distal end <NUM> of the inflow loading assembly <NUM>, the open end <NUM> extends beyond the coupling members of a medical device extending from the open end <NUM> of the outflow loading assembly <NUM>.

In embodiments, an inner diameter of the open end <NUM> is sized to receive a tip of a delivery system. An outer diameter of the main body portion <NUM> is preferably sized so that the main body portion <NUM> can pass through the channel collectively defined by the outflow loading assembly <NUM> and the inflow the inflow loading assembly <NUM> (and a slot defined by a body the backplate <NUM>).

<FIG> and <FIG> illustrate an example of a delivery system <NUM> in accordance with an embodiment hereof. One skilled in the art will realize that <FIG> and <FIG> illustrate one example of a delivery system and that existing components illustrated in <FIG> and <FIG> may be removed and/or additional components may be added to the delivery system <NUM>.

As shown in <FIG>, delivery system <NUM> generally comprises a catheter portion <NUM>, a distal portion <NUM>, and a proximal control handle portion <NUM> by which the distal portion <NUM> is effectively controlled. The catheter portion <NUM> is preferably of a length and size so as to permit a controlled delivery of the distal portion <NUM> to a desired implant location, for example, a patient's heart. In embodiments, the catheter portion <NUM> includes features to enhance maneuverability, steerability and advancement of the distal portion <NUM> to the point of implantation. The distal portion <NUM> preferably provides the means by which an implantable medical device, e.g., a prosthetic valve and stent, can be mounted for delivery to the implant location and further provides for allowing the expansion of the implantable medical device for effective deployment thereof. The control handle portion <NUM> preferably controls movements as translated to the distal portion <NUM> by way of elongate structure of the catheter portion <NUM>. Controlled functionality from the control handle portion <NUM> is preferably provided in order to permit expansion and deployment of the implantable medical device at a desired location, such as a heart valve annulus, and to provide for ease in the delivery and withdrawal of the delivery system through a patient's vasculature.

The catheter portion <NUM> of the delivery system <NUM> also preferably comprises an outer shaft <NUM> that is also operatively connected with the control handle portion <NUM> and that surrounds one or more inner shafts, e.g., an inner shaft <NUM> as illustrated in <FIG> which is an enlarged view of the distal portion <NUM>, over at least a part of its length. In embodiments, the outer shaft <NUM> comprises a lubricous inner layer (such as high density polyethylene HDPE or Polytetrafluoroethylene PTFE), braided stainless steel middle layer with a flexible plastic outer layer, such as comprised of Pebax <NUM>, or Nylon <NUM>. The outer shaft <NUM> may extend from the control handle portion <NUM> and may facilitate the advancement and steering of the delivery system along a guide wire and through a patient's vasculature, in particular by improving the pushability of the delivery system <NUM>.

The outer shaft <NUM> is preferably operatively connected with the control handle portion <NUM> so as to be movable by operation of the handle control portion and that is connected with a sheath or capsule <NUM> as further illustrated in <FIG>, which is an enlarged view of the distal portion <NUM>. Thus, telescopic movement of the outer shaft <NUM> by operation of the control handle portion <NUM> results in the longitudinal translational movement of the capsule <NUM>. The control handle portion <NUM> is designed, among other things, for controlling the advancement and the withdrawal of the capsule <NUM>.

As illustrated in <FIG>, the distal portion <NUM> may also include one or more attachment members, e.g., a spindle <NUM>, that is coupled to an inner shaft <NUM>. The spindle <NUM> may be configured to couple the implantable medical device to the catheter portion <NUM> of the delivery system <NUM>. The spindle <NUM> can include one or more coupling members, for example, two opposing pockets <NUM>. The pockets <NUM> can be recesses sized and shaped to closely correspond to the size and shape of coupling members of an implantable medical device, e.g., paddles of a prosthetic heart valve described below in <FIG>.

A nosecone <NUM> may be coupled to the inner shaft <NUM> and/or spindle <NUM> by a pin <NUM> at a distal end of the distal portion <NUM> and operates as the leading feature of delivery system <NUM>. The inner shaft <NUM> can also include an axial lumen (not shown) extending entirely through at least the inner shaft <NUM>, the spindle <NUM>, pin <NUM>, and the nosecone <NUM>, the purpose of which is for receiving a guidewire in order for the delivery system <NUM> to be guided along a patient's vasculature to an implant location. The guidewire, not shown, may be used in a conventional manner to guide the delivery system along it and with its distal end guided to its desired implant location.

In embodiments, the implantable medical devices useful with the present disclosure can be a prosthetic valve sold under the trade name CoreValve® available from Medtronic, Inc. , Evolut™ Pro+ available from Medtronic, Inc. , and the like. A non-limiting example of an implantable medical device useful with systems, devices and methods of the present disclosure is illustrated in <FIG> and <FIG>. In particular, <FIG> illustrates a side view of a prosthetic heart valve <NUM> in a normal or expanded (uncompressed) arrangement. <FIG> illustrates the prosthetic heart valve <NUM> in a compressed arrangement (e.g., when compressively retained within delivery system such as the distal portion <NUM> of the delivery system <NUM>). The prosthetic heart valve <NUM> includes a stent or frame <NUM> and a valve structure <NUM>. The stent <NUM> can assume any of the forms described above, and is generally constructed so as to be expandable from the compressed arrangement (<FIG>) to the uncompressed arrangement (<FIG>). In some embodiments, the stent <NUM> is self-expanding. In other embodiments, the stent <NUM> is designed to the expanded arrangement by a separate device (e.g., a balloon internally located within the stent <NUM>). The valve structure <NUM> is assembled to the stent <NUM> and provides two or more (typically three) leaflets <NUM>. The valve structure <NUM> can be assembled to the stent <NUM> in various manners, such as by sewing the valve structure <NUM> to one or more of the wire segments or commissure posts defined by the stent <NUM>.

The prosthetic heart valve <NUM> of <FIG> can be configured to replace or repair an aortic valve. Alternatively, other shapes are also envisioned, adapted to the specific anatomy of the valve to be repaired (e.g., stented prosthetic heart valves in accordance with the present disclosure can be shaped and/or sized for replacing a native mitral, pulmonic, or tricuspid valve). With the example of <FIG>, the valve structure <NUM> extends less than the entire length of the stent <NUM>, but in other embodiments can extend along an entirety, or a near entirety, of a length of the stent <NUM>. A wide variety of other constructions are also acceptable and within the scope of the present disclosure. For example, the stent <NUM> can have a more cylindrical shape in the normal, expanded arrangement.

The stent <NUM> includes support structures that comprise a number of struts or wire portions <NUM> arranged relative to each other to provide a desired compressibility and strength to the valve structure <NUM>. The stent <NUM> can also include one or more paddles <NUM> that removably couple the prosthetic heart valve <NUM> to a delivery system, e.g., the delivery system <NUM>. While <FIG> illustrate paddles <NUM>, one skilled in the art will realize that the paddles <NUM> can be replaced with other components such as eyelets, loops, slots, or any other suitable coupling member. The paddles <NUM> (or other portion of the stent <NUM>) can include one or more radiopaque markers that aid in the positioning and orientation of the prosthetic heart valve <NUM>. The struts or wire portions <NUM> form a lumen having an inflow end <NUM> and an outflow end <NUM>. The struts or wire portions <NUM> can be arranged such that the struts or wire portions <NUM> are capable of transitioning from the compressed arrangement to the uncompressed arrangement. These wires are arranged in such a way that the stent <NUM> allows for folding or compressing or crimping to the compressed arrangement in which the internal diameter is smaller than the internal diameter when in the uncompressed arrangement. In the compressed arrangement, such the stent <NUM> with attached valve structure <NUM> can be mounted onto a delivery system, such as the distal portion <NUM> the delivery system <NUM>. The stent <NUM> are configured so that they can be changed to an uncompressed arrangement when desired, such as by the relative movement of one or more sheaths relative to a length of the stent <NUM>.

In embodiments, the struts or wire portions <NUM> of the stent <NUM> can be formed of a metal or other material that can be expanded from a compressed arrangement to an uncompressed arrangement by an expansion device, e.g., balloon. In some embodiments, the wires of the support structure of the stent <NUM> in embodiments of the present disclosure can be formed from a shape memory material such as a nickel titanium alloy (e.g., Nitinol). With this material, the support structure is self-expandable from the compressed arrangement to the normal, expanded arrangement, such as by the application of heat, energy, and the like, or by the removal of external forces (e.g., compressive forces). This stent <NUM> can also be compressed and re-expanded multiple times without significantly damaging the structure of the stent frame. In addition, the stent <NUM> of such an embodiment may be laser-cut from a single piece of material or may be assembled from a number of different components or manufactured from a various other methods known in the art.

In embodiments, the stent <NUM> can generally be tubular support structures having an internal area in which the leaflets <NUM> can be secured. The leaflets <NUM> can be formed from a variety of materials, such as autologous tissue, xenograph material, or synthetics as are known in the art. In some embodiments, the leaflets <NUM> may be provided as a homogenous, biological valve structure, such as porcine, bovine, or equine valves. In some embodiments, the leaflets <NUM> can be provided independent of one another and subsequently assembled to the support structure of the stent <NUM>. In some embodiments, the stent <NUM> and the leaflets <NUM> can be fabricated at the same time, such as may be accomplished using high-strength nano-manufactured NiTi films produced at Advanced Bioprosthetic Surfaces (ABPS), for example. The stent <NUM> can be configured to accommodate at least two (typically three) of the leaflets <NUM> but can incorporate more or fewer than three of the leaflets <NUM>.

<FIG> and <FIG> illustrates an example of a method <NUM> for loading an implantable medical device using the loading system <NUM>, in accordance with an embodiment hereof. One skilled in the art will realize that <FIG> and <FIG> illustrate one example of a method using the loading system <NUM> and that existing operations illustrated in <FIG> and <FIG> may be removed and/or additional operations may be added to the method <NUM>. In some embodiments, some or all of the operations of loading an implantable medical device are performed in a liquid bath, for example, a cold saline bath. Accordingly, in some embodiments, the materials used for components of the loading system <NUM> are relatively dimensionally stable when exposed to temperatures at or relatively near the temperature of the liquid bath being used.

In step <NUM>, a capsule guide can be moved to an unlocked position. For example, as illustrated in <FIG>, the locking collar <NUM> of the capsule guide <NUM> can be retracted to abut the handle <NUM>, thereby being in an unlocked position. In step <NUM>, the capsule guide <NUM> can be positioned on a delivery system and advanced. For example, as illustrated in <FIG>, the capsule guide <NUM> in the unlocked position, can be advanced over the distal portion <NUM> of the delivery system <NUM> by inserting the distal end of the delivery system into the handle <NUM> of the capsule guide <NUM> and advancing the capsule guide <NUM> proximally until the distal open end <NUM> of the guide tube <NUM> is between the spindle <NUM> of the catheter portion <NUM> and the nosecone <NUM>.

In step <NUM>, the capsule guide is locked and positioned. For example, as illustrated in <FIG>, the locking collar <NUM> of the capsule guide <NUM> can be moved toward the distal open end <NUM>. The locking collar <NUM> locks the capsule guide <NUM> prior to advancing the capsule guide <NUM> over the distal portion <NUM>, e.g., a capsule. In embodiments, the locking collar <NUM> can cause the capsule guide <NUM> and a flexible capsule to operate as rigid objects, while the locking collar <NUM> is engaged. The locking collar <NUM> can compress the two halves of the capsule guide <NUM> together. The compression of the capsule guide <NUM> can form a ring that limits a flare of the delivery system from expanding. Additionally, the compression of the locking collar <NUM> can protect components the delivery system and the capsule guide <NUM> from damage as the prosthetic heart valve <NUM> is being loaded.

In step <NUM>, one end of the implantable medical device is inserted into an inflow loading assembly. For example, as illustrated in <FIG>, with the backplate <NUM> inserted, an implantable medical device, e.g., the prosthetic heart valve <NUM>, is inserted into the inflow loading assembly <NUM>. In this example, the inflow end <NUM> of the prosthetic heart valve <NUM> can be aligned and inserted into the proximal opening <NUM> at the proximal end <NUM> of the inflow loading assembly <NUM>. As discussed above, an inner surface of second portion <NUM> of the inflow loading assembly <NUM> can be sized to create an interference fit with the inflow end <NUM> of the prosthetic heart valve <NUM>. The prosthetic heart valve <NUM> can be oriented such that the paddles <NUM> are substantially in a vertical plane and one of the paddles <NUM> is aligned with the backplate <NUM> extending from the inflow loading assembly <NUM>. Once inserted, the inflow end <NUM> of the prosthetic heart valve <NUM> can be adjacent to and can abut the backplate <NUM>.

In step <NUM>, an outflow loading assembly is attached to the inflow loading assembly. For example, as illustrated in <FIG>, the outflow loading assembly <NUM> is advanced over the outflow end <NUM> of the prosthetic heart valve <NUM> thereby partially compressing the stent <NUM>. The outflow end <NUM> of the prosthetic heart valve <NUM> may be advanced along the tapered interior surface of the portion <NUM> of the outflow loading assembly <NUM> to compress the outflow end <NUM> of the prosthetic heart valve <NUM>. The compression occurs by advancing the outflow loading assembly <NUM>, with distal open end <NUM> facing the prosthetic heart valve <NUM>, towards the prosthetic heart valve <NUM> seated in the inflow loading assembly <NUM>.

The outflow loading assembly <NUM> may be advanced over the prosthetic heart valve <NUM> until the outflow loading assembly <NUM> couples with the inflow loading assembly <NUM>. The outflow loading assembly <NUM> can be advanced until the distal open end <NUM> of the outflow loading assembly <NUM> is adjacent the proximal end <NUM> of the inflow loading assembly <NUM>. That is, the engagement tabs <NUM> of the outflow loading assembly <NUM> are aligned with the tabs <NUM> of the inflow loading assembly <NUM>, and the outflow loading assembly <NUM> is advanced until the engagement tabs <NUM> and the tabs <NUM> engage. The backplate <NUM> can apply an axial force to advance the prosthetic heart valve <NUM> relative to the outflow loading assembly <NUM> into a desired final position within the outflow loading assembly <NUM>. For example, the inflow end <NUM> of the prosthetic heart valve <NUM> contacts the backplate <NUM>.

In step <NUM>, a tip guide tube is inserted into the inflow loading assembly. For example, as illustrated in <FIG>, the tip guide tube <NUM> can be inserted in the distal opening <NUM> at the distal end <NUM> of the inflow loading assembly <NUM>. The tip guide tube <NUM> can be introduced into the distal opening <NUM> at the distal end <NUM> of the inflow loading assembly <NUM> and advanced within the inflow loading assembly <NUM> and the outflow loading assembly <NUM> until the tip guide tube <NUM> contacts the outflow end <NUM> of the prosthetic heart valve <NUM>, for example, an inner surface of stent <NUM> of the prosthetic heart valve <NUM>. Movement of the tip guide tube <NUM> in a proximal direction through the prosthetic heart valve <NUM> can properly orient the leaflets <NUM> of the valve structure <NUM> such that the risk of damaging the leaflets <NUM> is reduced while the prosthetic heart valve <NUM> is further reduced is radial size.

In some embodiments, the tip guide tube <NUM> can be further advanced to pass through the proximal open end <NUM> of the outflow loading assembly <NUM> such that the tip guide tube <NUM> contacts the portion of the prosthetic heart valve <NUM> extending beyond through the proximal open end <NUM> of the outflow loading assembly <NUM>. The tip guide tube <NUM> contact expands this portion of the outflow end <NUM> of the prosthetic heart valve <NUM>, spreading open the stent <NUM>. The tip guide tube <NUM> can contact the portion of prosthetic heart valve <NUM> extending beyond the proximal open end <NUM> when handle portion <NUM> of the tip guide tube <NUM> is adjacent to or abuts the distal end <NUM> of the inflow loading assembly <NUM>.

At this point, a user can inspect outflow crowns of the stent <NUM> to ensure that the outflow crowns are evenly spaced and that the paddles <NUM> are opposite from each other. If a misalignment exists, a user can manually adjust the stent <NUM> to achieve the desired configuration. For example, a user can directly inspect the outflow crowns and the paddle(s) <NUM> directly facing the user, and can indirectly inspect the outflow crowns and the paddle(s) <NUM> facing away from the user by using a mirror in a loading tray used to load the prosthetic heart valve <NUM> into the delivery system <NUM>.

In step <NUM>, the implantable medical device is coupled to the delivery system. For example, as illustrated in <FIG>, the prosthetic heart valve <NUM> and the loading system <NUM> are positioned over the nosecone <NUM>. That is, the nosecone <NUM> is inserted into the tip guide tube <NUM> and advanced. The distal portion <NUM> is advanced until the paddles <NUM> of the stent <NUM> are aligned with the attachment location of the distal portion <NUM>, e.g., the pockets <NUM> of the spindle <NUM>. The distal portion <NUM> can be advanced using the capsule guide <NUM>.

Once approximately aligned, the tip guide tube <NUM> is retracted in order to seat the paddles <NUM> with the pockets <NUM> of the spindle <NUM>. That is, the tip guide tube <NUM> is distally retracted relative to prosthetic heart valve <NUM>, releasing contact between the tip guide tube <NUM> and the outflow end <NUM> of the prosthetic heart valve <NUM> extending beyond the proximal open end <NUM> of the outflow loading assembly <NUM>. As illustrated in <FIG>, the contact release allows outflow portion of the prosthetic heart valve <NUM> to contract such that the paddles of the stent <NUM> of engage the pockets <NUM> of the spindle <NUM>.

At this point, a user can inspect that the prosthetic heart valve <NUM> is correctly coupled to the delivery system. For example, a user can inspect that the paddles <NUM> of the prosthetic heart valve <NUM> are correctly seated within the pockets <NUM> of the spindle <NUM>. A user can directly inspect this coupling facing the user and can indirectly inspect the coupling facing away from the user by using the mirror, as illustrated in <FIG>. If a misalignment exists, a user can manually adjust the paddles <NUM> to achieve the desired seating configuration.

In step <NUM>, the capsule guide is advanced and an end of the implantable medical device is secured within the delivery system. For example, as illustrated in <FIG>, a force is applied the capsule guide <NUM> is advanced towards the outflow loading assembly <NUM> until the open distal end <NUM> covers the spindle <NUM>. Then, as illustrated in <FIG>, the control handle portion <NUM> can be actuated and to advance the capsule <NUM> until the capsule <NUM> covers the spindle <NUM>. As such, the capsule <NUM> secures the paddles <NUM> within the pockets <NUM> of the spindle <NUM>. Then, as illustrated in <FIG>, the capsule tube <NUM> can first be advanced over the commissure pads of the prosthetic heart valve <NUM>. Subsequently, the control handle portion <NUM> can be actuated and to advance the capsule <NUM> until the capsule <NUM> covers the commissure pads of the prosthetic heart valve <NUM>.

In step <NUM>, the end of the implantable medical device is compressed using the inflow loading assembly. For example, the backplate <NUM> and the tip guide tube <NUM> can be removed from the inflow loading assembly <NUM>. Once removed, the capsule guide <NUM> can be held stationary, and the inflow loading assembly <NUM> can be advanced over the inflow end of the prosthetic heart valve <NUM>, as illustrated in <FIG>. Once the prosthetic heart valve <NUM> is compressed, the capsule <NUM> can be advanced to the nosecone <NUM> thereby covering the prosthetic heart valve <NUM>. The capsule guide <NUM> can then be removed from the catheter portion <NUM> by moving the locking collar <NUM> to the unlock position and sliding the capsule guide <NUM> over the distal potion <NUM> and off the distal end of the catheter potion <NUM>.

As discussed above, the inflow loading assembly <NUM> includes one or more portions that have a non-circular cross-sections and one or more biasing features, as illustrated in <FIG> and <FIG> and <FIG> that apply a compression force, unevenly, to the exterior surfaces of the implantable medical device. The non-circular cross-sections and/or one or more biasing features are designed to cause overlap of the structural components of the prosthetic heart valve <NUM> (e.g., struts and crowns) at multiple and select locations. This prevents circumferential pressure build-up by biasing the structural components inwards in predefined areas. As such, the non-circular cross-sections and/or one or more biasing features distribute the overlap of the structural components evenly within interior free spaces of the prosthetic heart valve <NUM>. As such, the non-circular cross-sections and/or one or more biasing features may reduce the occurrence of a concentration of the structural components of the prosthetic heart valve <NUM> and provide predictability of the location of the overlap. The distributed overlap may allow for safe loading the prosthetic heart valve <NUM> into lower profile delivery systems.

Although <FIG> described above illustrate the loading system <NUM> with a prosthetic heart valve, the loading system <NUM> can be used to load any suitable medical device, for example, implants, stents, and other implantable or temporary prostheses that do not include a valve assembly.

<FIG> and <FIG> illustrate an example of a crimper <NUM> in accordance with an embodiment hereof. One skilled in the art will realize that <FIG> and <FIG> illustrate one example of a crimper and that existing components illustrated in <FIG> and <FIG> may be removed and/or additional components may be added to the crimper <NUM>.

As illustrated in <FIG>, the crimper <NUM> includes a handle <NUM>, a crimper housing <NUM>, and a base <NUM>. The crimper housing <NUM> may include an opening <NUM> from a first side <NUM> of the crimper housing <NUM> to a second side (not shown) of the crimper housing <NUM> that is opposite the first side <NUM>. The opening <NUM> can be formed in an approximate circular cross-sectional shape. The opening <NUM> can allow access to a crimper chamber <NUM> of the crimper <NUM> as described in further detail below. The crimper chamber <NUM> is formed by a plurality of crimper elements <NUM>. The handle <NUM> extends into the crimper housing <NUM> and may couple to one or more actuating mechanisms (not shown), e.g., rods, cams, actuator rings, etc..

In embodiments, the one or more actuating mechanisms are coupled to a plurality of crimper elements <NUM>. The one or more actuating mechanisms may operate to translate the rotational movement of the handle <NUM> to the crimper elements <NUM>. In operation, the crimper elements <NUM> are displaced by the movement of the handle <NUM>. That is, as the handle <NUM> is moved, the two cams <NUM> may rotate and the rods <NUM> may function to translate the rotational motion of the handle <NUM> into linear motion of the crimper elements <NUM>. As such, the crimper elements <NUM> of the crimper housing <NUM> may function as an iris to decrease or increase the volume of the crimper chamber <NUM> through the movement of the handle <NUM>, as described below in further detail. The crimper chamber <NUM> can define a volume that approximates a cylinder. While the crimper chamber <NUM> is described above as defining a cylindrically shaped volume, one skilled in the art will realize that the shape and dimension of the lobes can be changed to create a differently shaped volume as required by the implantable medical device being compressed and positioned.

In embodiments, as illustrated in <FIG>, the crimper <NUM> operates to convert an implantable medical device from its uncompressed arrangement to its compressed arrangement. In operation, the implantable medical device, e.g., prosthetic heart valve <NUM>, is loaded into the crimper chamber <NUM> and positioned in a direction that is parallel to the long axis of the base <NUM>. Portions of delivery system, e.g., catheter <NUM> of the delivery system <NUM>, can also be positioned and aligned relative to the implantable medical device. Similar to the loading system <NUM>, to address these drawbacks and allow loading in low profile delivery systems, the crimper element <NUM> are designed to bias select portions of the implantable medical device towards a central axis of the implantable medical device.

Each of the crimper elements <NUM> may include a crimper lobe <NUM>. <FIG> illustrated a detailed view of a crimper lobe <NUM>. The crimper lobe <NUM> preferably includes a bottom surface <NUM>. The bottom surface <NUM> defines a portion of the crimper chamber <NUM>. In embodiments, the bottom surface <NUM> of the crimper lobe <NUM> includes one or more biasing features <NUM> that apply compression force unevenly to the exterior surfaces of the implantable medical device, as illustrated in <FIG> and discussed below in further detail. The biasing features <NUM> are designed to cause overlap of the structural components of the implantable medical device at multiple and select locations. As such, the biasing features <NUM> distribute the overlap of the structural components evenly within the free space of the implantable medical device, thereby reducing the occurrence of a concentration of the structural components of the implantable medical device. The distributed overlap may allow for safe loading the implantable medical device into lower profile delivery systems. The structural components are crimped asymmetrically. This prevents circumferential pressure build-up by biasing the structural components inwards in predefined areas. This gives predictability in where an overlap of the structural components may occur.

As illustrated in <FIG>, the bottom surface <NUM> of the crimper lobe <NUM> can include two of the biasing features <NUM>. Each of the biasing features <NUM> can be formed as a semi-circular ridge that extends on the bottom surface <NUM> from a front of the crimper lobe <NUM> to a back of the crimper lobe <NUM>. In embodiments, when formed as a semi-circular ridge, each of the biasing features <NUM> can be formed to any dimensions, e.g., radius and length, in order to provide an asymmetric compression force on the implantable medical device. In some embodiment, a radius of a biasing feature <NUM> can range from approximately <NUM> to approximately <NUM>. In some embodiments, a length of the biasing feature <NUM> can range between approximately <NUM> to approximately <NUM>. In some embodiments, the dimensions of the biasing features <NUM> can be constant. In some embodiments, the dimensions of the biasing features <NUM> can vary. For example, the radius of biasing features <NUM> can increase and/or decrease along the length of the biasing features <NUM>. That is, each of the biasing features <NUM> may have a larger radius at the front of the crimper lobe <NUM> as compared to the back of the crimper lobe <NUM>, or vice versa.

In some embodiments, as illustrated in <FIG>, the biasing feature <NUM> can extend an entire length of the bottom surface <NUM>, e.g., from the front of the crimper lobe <NUM> to the back of the crimper lobe <NUM>. In some embodiments, the biasing feature <NUM> can extend only a portion of the length of the bottom surface <NUM>, e.g., from the front of the crimper lobe <NUM> to the back of the crimper lobe <NUM>. While <FIG> illustrates the biasing features <NUM> as being semi-circular ridge, one skilled in the art will realize that a biasing feature can be formed in any shape and/or size. Likewise, while <FIG> illustrates two of the biasing features <NUM>, one skilled in the art will realize that the crimper lobe <NUM> can include any number of biasing features <NUM>.

While the components of the crimper <NUM> are described above with relative terms "first," "second," "proximal," and "distal," one skilled in the art will realize that the use of these terms is intended only to identify components of the crimper <NUM> and do not define any preferred or ordinal arrangement of the components of crimper <NUM>.

Claim 1:
A system for transitioning an implantable medical device from an uncompressed arrangement to a compressed arrangement, the device comprising:
an inflow loading assembly (<NUM>) configured to compress an inflow portion of the implantable medical device as the implantable medical device is advanced through the inflow loading assembly; and
an outflow loading assembly (<NUM>) removably coupled to the inflow loading assembly, wherein:
the outflow loading assembly is configured to partially compress an outflow portion of the implantable medical device during coupling to the inflow loading assembly, and
the inflow loading assembly comprises one or more biasing features (<NUM>, <NUM>, <NUM>) that are configured to asymmetrically compress the inflow portion of the implantable medical device by biasing structural components of the implantable medical device inwards in predefined areas;
wherein the inflow loading assembly comprises a first portion (<NUM>, <NUM>) and a second portion (<NUM>, <NUM>) extending therefrom, and wherein at least one of the first portion or the second portion comprises the one or more biasing features; and
wherein at least one of the first portion or the second portion is formed having a non-circular cross-section that provides a non-uniform compression force.