Patent Description:
A variety of maladies may affect an individual's body. Such maladies may be of the individual's heart, and may include maladies of the individual's heart valves, including the aortic, mitral, tricuspid, and pulmonary valves. Stenosis, for example, is a common and serious valve disease that may affect the operation of the heart valves and an individual's overall well-being.

Implants may be provided that may replace or repair portions of a patient's heart. Prosthetic implants, such as prosthetic heart valves, may be provided to replace a portion of a patient's heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided.

Implants may be deployed to the desired portion of the patient's body percutaneously, in a minimally invasive manner. Such deployment may occur transcatheter, in which a catheter may be deployed through the vasculature of an individual.

During deployment of such implants, the implants must be expanded to provide an expanded configuration for such implant. Care must be taken to properly expand the implants to a desired implantation site, and to avoid over expansion or under expansion of such implants.

<CIT> relates to a balloon catheter for mounting a stent on a balloon, preventing damage, and improving the passage and sliding properties of the balloon with the stent mounted thereon. The balloon catheter includes: a first balloon and a second balloon sequentially arranged from the distal end to the proximal end; a first tubular shaft having a first dilation lumen communicating with the first balloon; a second tubular shaft which has a second dilation lumen <NUM> communicating with the second balloon and where the first tubular shaft <NUM> is internally inserted therein; and a stent mounted on the second balloon.

<CIT> relates to apparatus and methods for delivering a stent into an ostium. The apparatus includes a catheter including a proximal end, a distal end, and proximal and distal balloons disposed adjacent one another on the distal end. The balloons are expandable independently of one another, and a stent is provided surrounding the balloons. During use, the distal end of the catheter is introduced into a main lumen, and the proximal balloon is inflated to flare a proximal portion of the stent. The distal end is then advanced into the ostium until the flared proximal portion contacts a wall of the main lumen surrounding the ostium. The distal balloon is inflated to expand a distal portion of the stent, e.g., to dilate a lesion within the branch and/or ostium.

Expandable implants may be expanded by inflatable bodies, which may comprise balloons or another form of inflatable body. Upon expansion of the expandable implants by the inflatable bodies, care must be taken to assure that the expandable implant is positioned in the desired location upon the inflatable body, to provide the desired implantation location and expansion size of the expandable implant. These concerns may be increased with "V" shaped implants, as "V" shaped implants might slip upon the inflatable body and produce an undesired position of the implant upon the inflatable body. Further, "V" shaped implants may have an expansion size that depends on the position of the implant upon an inflatable body.

Embodiments disclosed herein may be directed to improved positioning of an expandable implant upon one or more inflatable bodies upon expansion of the inflatable bodies. Embodiments may be utilized with a "V" shaped implant. The invention is directed to a system according to claim <NUM>.

The system includes a first inflatable body having a first outer diameter when in an inflated state. The system includes a second inflatable body positioned adjacent to the first inflatable body and having an outer surface configured to apply an expansion force to the expandable implant and having a shape that tapers downward in a direction towards the first inflatable body to a narrow portion having a second outer diameter that is less than the first outer diameter when the second inflatable body is in an inflated state.

Embodiments as disclosed herein may include a delivery system for an expandable implant. The delivery system may include a delivery apparatus configured to deliver the expandable implant to a location in a patient's body. The delivery apparatus may include an elongate shaft and a first inflatable body coupled to the elongate shaft and having a first outer diameter when in an inflated state. The delivery apparatus may include a second inflatable body coupled to the elongate shaft adjacent to the first inflatable body and having an outer surface configured to apply an expansion force to the expandable implant and having a shape that tapers downward in a direction towards the first inflatable body to a narrow portion having a second outer diameter that is less than the first outer diameter when the second inflatable body is in an inflated state.

Embodiments as disclosed herein may include a method. The method may include inflating a first inflatable body. The method may include radially expanding an expandable implant positioned around an outer surface of a second inflatable body by inflating the second inflatable body, the second inflatable body being positioned adjacent to the first inflatable body and having an outer surface having a shape that tapers downward in a direction towards the first inflatable body to a narrow portion, with an outer diameter of the narrow portion being less than an outer diameter of the first inflatable body.

These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the disclosure. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.

The following description and examples illustrate some example embodiments of the disclosure in detail. Those of skill in the art will recognize that there are numerous variations and modifications of the disclosure that are encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present disclosure.

<FIG> illustrates a side cross sectional view of a system <NUM> for expansion of an expandable implant <NUM>. The system includes an inflatable body <NUM>, which is referred to as a first or proximal inflatable body, and includes an inflatable body <NUM>, which is referred to as a second or distal inflatable body.

The inflatable body <NUM> may include an outer wall <NUM> forming an outer surface <NUM> of the inflatable body <NUM>. The inflatable body <NUM> may have a first end <NUM> and a second end <NUM>. The first end <NUM> may be coupled to a portion of the second inflatable body <NUM>, and the second end <NUM> may be coupled to an elongate shaft <NUM> of a delivery apparatus configured to deliver the expandable implant <NUM> to a location in a patient's body. The inflatable body <NUM> may extend axially along the length of the elongate shaft <NUM> of the delivery apparatus in both a deflated state as shown in <FIG> and in an inflated state as shown in <FIG>.

The inflatable body <NUM> may be configured to have a rounded profile when in an inflated state. Such a profile is shown for example in <FIG>. The inflatable body <NUM> may extend radially outward from the elongate shaft <NUM> when in an inflated state, and may extend around the axis of the elongate shaft <NUM>. The inflatable body <NUM> may have a bulb shape as shown in <FIG> for example when in an inflated state, or may have another shape as desired. The inflatable body <NUM> may have an outer diameter <NUM> (as shown in <FIG>) when in an inflated state.

The inflatable body <NUM> has a shoulder portion <NUM>. The shoulder portion <NUM> may be positioned proximate to a narrow portion <NUM> of the second inflatable body <NUM> (as marked in <FIG> and <FIG>). When the inflatable body <NUM> is in a deflated state, as shown in <FIG>, for example, the shoulder portion <NUM> may comprise a bump formed by the outer wall <NUM> of the inflatable body <NUM>. The bump may be formed by the outer wall <NUM> being a folded portion, as shown in <FIG>, or the outer wall <NUM> may include a thicker portion at the shoulder portion <NUM> to form the bump in embodiments as desired. As shown in <FIG>, as the inflatable body <NUM> is inflated, the shoulder portion <NUM> may form an outwardly extending and curved surface extending to an apex <NUM> of the inflatable body <NUM>. The inflatable body <NUM> may include a downwardly tapering portion <NUM> on the opposite side of the apex <NUM>, extending downward to the second end <NUM> of the inflatable body <NUM>.

The outer wall <NUM> of the inflatable body <NUM> may surround an interior chamber <NUM> of the inflatable body <NUM> that may be configured to hold fluid (for example, a liquid or other fluid in embodiments) for inflating the inflatable body <NUM>. The interior chamber <NUM> may comprise a single chamber as shown in <FIG>, or a plurality of chambers utilized to hold fluid for inflating the inflatable body <NUM>. The interior chamber <NUM> may be sealed from outside of the inflatable body <NUM> by the coupling of the ends <NUM>, <NUM> of the inflatable body <NUM> to the inflatable body <NUM> and the elongate shaft <NUM>, respectively.

An inflation lumen <NUM> may be provided for passing fluid into the interior chamber <NUM> of the inflatable body <NUM>. The inflation lumen <NUM> may extend along the elongate shaft <NUM> and may have a proximal end that couples to a port <NUM> (as shown in <FIG>) for passing fluid into and out of the inflation lumen <NUM>, and may have a distal end with an opening for passing fluid into and out of the interior chamber <NUM> of the inflatable body <NUM>. The configuration of the inflation lumen <NUM> may be varied in other embodiments.

The inflatable body <NUM> (or second or distal inflatable body), similar to the inflatable body <NUM>, includes an outer wall <NUM> forming an outer surface <NUM> of the inflatable body <NUM>. The outer surface <NUM> of the inflatable body <NUM> is configured to apply an expansion force to the expandable implant <NUM>. The inflatable body <NUM> may have a first end <NUM> and a second end <NUM>. The first end <NUM> and second end <NUM> may each be coupled to the elongate shaft <NUM> of the delivery apparatus for the expandable implant <NUM>. The inflatable body <NUM> may extend axially along the length of the elongate shaft <NUM> of the delivery apparatus in both a deflated state as shown in <FIG> and in an inflated state as shown in <FIG>.

The inflatable body <NUM> may extend radially outward from the elongate shaft <NUM> when in an inflated state, and may extend around the axis of the elongate shaft <NUM>. The inflatable body <NUM> may have a conical frustum shape as shown in <FIG> for example when in an inflated state, or may have another shape as desired.

The inflatable body <NUM> may include a shoulder portion <NUM> that may be positioned proximate the first end <NUM> of the inflatable body <NUM>. When the inflatable body <NUM> is in a deflated state, as shown in <FIG>, for example, the shoulder portion <NUM> may comprise a bump formed by the outer wall <NUM> of the inflatable body <NUM>. The bump may be formed by the outer wall <NUM> being a folded portion, as shown in <FIG>, or the outer wall <NUM> may include a thicker portion at the shoulder portion <NUM> to form the bump in embodiments as desired. As shown in <FIG>, as the inflatable body <NUM> is inflated, the shoulder portion <NUM> may form an outwardly extending and curved surface that is positioned offset from the expandable implant <NUM>. The shoulder portion <NUM> may include a surface extending from an apex <NUM> of the inflatable body <NUM> in a direction towards the second end <NUM> of the inflatable body <NUM>. The inflatable body <NUM> may include a downwardly tapering portion <NUM> on the opposite side of the apex <NUM>, extending downward to the first end <NUM> of the inflatable body <NUM>.

The outer surface <NUM> of the inflatable body has a shape that tapers downward in a direction towards the inflatable body <NUM> to a narrow portion <NUM> (as marked in <FIG> and <FIG>) when the inflatable body <NUM> is in an inflated state. The narrow portion <NUM> has have an outer diameter <NUM> (as shown in <FIG> and <FIG>) when in an inflated state. The outer diameter <NUM> of the narrow portion <NUM> is less than the outer diameter <NUM> of the inflatable body <NUM>.

The outer wall <NUM> of the inflatable body <NUM> may surround an interior chamber <NUM> of the inflatable body <NUM> that may be configured to hold fluid (for example, a liquid or other fluid in embodiments) for inflating the inflatable body <NUM>. The interior chamber <NUM> may comprise a single chamber as shown in <FIG>, or a plurality of chambers utilized to hold fluid for inflating the inflatable body <NUM>. The interior chamber <NUM> may be sealed from outside of the inflatable body <NUM> and from the interior chamber <NUM> of the inflatable body <NUM> by the coupling of the ends <NUM>, <NUM> of the inflatable body <NUM> to the shaft <NUM>.

An inflation lumen <NUM> may be provided for passing fluid into the interior chamber <NUM> of the inflatable body <NUM>. The inflation lumen <NUM> may extend along the elongate shaft <NUM> and may have a proximal end that couples to a port <NUM> (as shown in <FIG>) for passing fluid into and out of the inflation lumen, and may have a distal end with an opening for passing fluid into and out of the interior chamber <NUM> of the inflatable body <NUM>. The inflation lumen <NUM> may be configured to extend around an interior shaft <NUM> (e.g., a guide wire lumen) of the elongate shaft <NUM>, with the inflation lumen <NUM> extending around and concentric with the inflation lumen <NUM>. The configuration of the inflation lumen <NUM> may be varied in other embodiments.

Each inflatable body <NUM>, <NUM> may be configured to be inflated by fluid passing into the respective chambers <NUM>, <NUM> and may be configured to be deflated by fluid passing out of the respective chambers <NUM>, <NUM>. The inflatable bodies <NUM>, <NUM> may be configured to be separately inflated and deflated as desired. The inflatable bodies <NUM>, <NUM> in embodiments may comprise balloons, which may be non-compliant in embodiments. As such, the inflatable bodies <NUM>, <NUM> may be pre-formed to have the shapes in an inflated state as shown in <FIG> for example, and may then be inflated to that shape. In embodiments, the inflatable bodies <NUM>, <NUM> may be semi-compliant or compliant as desired. The inflatable bodies <NUM>, <NUM> may be pre-formed with the shapes shown in the inflated state as shown in <FIG> or may otherwise be configured to form the shapes shown in <FIG>.

The inflatable bodies <NUM>, <NUM> may be positioned adjacent to each other. The inflatable bodies <NUM>, <NUM> may be positioned adjacent to each other axially along the length of the elongate shaft <NUM>. The inflatable bodies <NUM>, <NUM> may be positioned with the first inflatable body <NUM> positioned proximal along the length of the elongate shaft <NUM> and the second inflatable body <NUM> positioned distal along the length of the elongate shaft <NUM> as shown in <FIG> for example. In embodiments, the inflatable bodies <NUM>, <NUM> may be positioned with the first inflatable body <NUM> positioned distal along the length of the elongate shaft <NUM> and the second inflatable body <NUM> positioned proximal along the length of the elongate shaft <NUM> as shown in <FIG> for example. The inflatable bodies <NUM>, <NUM> may positioned adjacent to each other and may be in contact with each other, or a gap may be positioned between the inflatable bodies <NUM>, <NUM>, or another device may be positioned between the inflatable bodies <NUM>, <NUM>.

In an embodiment as shown in <FIG>, a portion of one of the inflatable bodies <NUM>, <NUM> may overlap a portion of another of the inflatable bodies <NUM>, <NUM>. For example, as shown in <FIG>, the first end <NUM> of the first inflatable body <NUM> may comprise an overlap portion that overlaps the second inflatable body <NUM>. The first end <NUM> overlaps and couples to the narrow portion <NUM> of the second inflatable body <NUM>. The shoulder portion <NUM> of the first inflatable body <NUM> further comprises an overlap portion that overlaps the second end <NUM> of the second inflatable body <NUM>. The overlap of the first inflatable body <NUM> over the second inflatable body <NUM> may allow the first inflatable body <NUM> to increase in size along with the inflation of the second inflatable body <NUM>. For example, as shown in <FIG> and <FIG>, the first end <NUM> of the first inflatable body <NUM> is coupled to the narrow portion <NUM> of the second inflatable body <NUM> such that an inflation of the narrow portion <NUM> causes the first end <NUM> of the first inflatable body <NUM> to increase in size. In other embodiments, for example as shown in <FIG>, the inflatable bodies may not be coupled to each other.

The expandable implant <NUM> may comprise an implant <NUM> configured to be radially expanded outward via an expansion force applied by the inflatable body <NUM>. <FIG>, for example, illustrates a side view of such an implant <NUM>, including a frame <NUM> that is configured to allow the expandable implant <NUM> to expand. The frame <NUM> may be configured as a plurality of struts coupled to each other with spaces between the struts. The frame <NUM> may be configured such that as the implant <NUM> is expanded radially outward (for example in a direction shown by the arrows <NUM> extending outward from the implant axis <NUM>) the length <NUM> of the implant <NUM> may shorten. In addition, the frame <NUM> may be configured such that as the implant <NUM> is radially compressed, the length <NUM> of the implant <NUM> may increase.

Notably, the implant <NUM> may be configured to shorten in a direction. For example, the implant <NUM> as shown in <FIG> may include a first end <NUM> and a second end <NUM>. Upon the second end <NUM>, for example, being maintained in a position and the first end <NUM> being free to move, an expansion force against the implant <NUM> will cause the length <NUM> of the implant <NUM> to shorten in a direction towards the second end <NUM> (with the first end <NUM> moving towards the second end <NUM>). Similarly, if the first end <NUM> were maintained in a position and the second end <NUM> were free to move, an expansion force against the implant <NUM> will cause the length <NUM> of the implant <NUM> to shorten in a direction towards the first end <NUM> (with the second end <NUM> moving towards the first end <NUM>).

The expandable implant <NUM> may have a variety of forms. For example, the expandable implant <NUM> may be utilized as a prosthetic heart valve, which may be utilized for implantation in the native aortic, mitral, tricuspid, or pulmonary valves. Other forms of expandable implants may be utilized, including stents or other implants.

The expandable implant <NUM> may be configured to have a tapered profile. <FIG>, for example, illustrates a cross sectional view of the implant <NUM>. Features of the implant are not shown for clarity. For example, prosthetic heart valve leaflets may not be shown in <FIG> for clarity in an embodiment in which the implant <NUM> is a prosthetic heart valve. The implant <NUM> has an angled interior profile that faces an interior cavity <NUM> of the implant <NUM>. The second end <NUM> is narrower than the first end <NUM> and the implant <NUM> has an inner surface <NUM> forming an angled interior profile from the first end <NUM> to the second end <NUM>. The implant <NUM> may be considered a "V" shaped implant or otherwise an implant having a conical frustum interior shape, or may comprise another form of frustum in other embodiments (e.g., pyramidal or another shape). The implant may have an outer profile that is the same as the interior profile, or may be different in other embodiments.

An implant <NUM> comprising a "V" shaped implant may have a variety of benefits, including having the prosthetic heart valve leaflets open in a direction towards the wide end (e.g., first end <NUM>) of the implant <NUM>. The prosthetic heart valve leaflets accordingly may have a reduced possibility of contacting the inner surface <NUM> of the implant <NUM> upon the leaflets moving to the open state. Other benefits may be provided as desired.

In embodiments, implants other than "V" shaped implants may be utilized. For example, a cylindrical shaped implant or other shape of implant may be utilized, which may be expanded to a tapered profile via use of the system <NUM> shown in <FIG>.

An issue that may arise upon expanding expandable implants, particularly implants that are expandable with an inflatable body, is producing desired positioning of the expandable implants upon the inflatable body. This issue may produce difficulties in positioning the implant relative to the desired implantation site, and may produce difficulties in producing a desired size of expansion of the expandable implant. This issue may be enhanced with "V" shaped implants, as the "V" shaped implants may slip upon the inflatable body and produce an undesired position of the implant upon the inflatable body. Further, "V" shaped implants may have an expansion size that depends on the position of the implant upon the inflatable body. The system <NUM> as disclosed herein may reduce the possibility of such issues arising, and may improve the positioning of the expandable implants upon one or more inflatable bodies.

Referring to <FIG>, the inflatable bodies <NUM>, <NUM> are shown in a deflated state. The expandable implant <NUM> is shown crimped onto the outer surface <NUM> of the inflatable body <NUM> and positioned around the outer surface <NUM>. The expandable implant <NUM> may extend longitudinally along the axis of the elongate shaft <NUM> and over the inflatable body <NUM>. The expandable implant <NUM> may be crimped upon the inflatable body <NUM> with a cylindrical outer shape, and with the first end <NUM> (the wide end as shown in <FIG>) of the implant <NUM> positioned proximate the shoulder portion <NUM> of the second inflatable body <NUM> and the second end <NUM> (the narrow end as shown in <FIG>) of the implant <NUM> positioned proximate the shoulder portion <NUM> of the first inflatable body <NUM>. The expandable implant <NUM> may be in a compressed state and thus may have a length that is greater than a length of the expandable implant <NUM> in an expanded state.

The first inflatable body <NUM> may be positioned axially offset from the expandable implant <NUM>. The first end <NUM> of the first inflatable body <NUM> may however be sandwiched between the second end <NUM> of the expandable implant <NUM> and the second inflatable body <NUM> as shown in <FIG>. The shoulder portion <NUM> of the second inflatable body <NUM> may be axially offset from the expandable implant <NUM>. As such, the implant <NUM> may not cover a portion of the first inflatable body <NUM> or the second inflatable body <NUM> in embodiments, with a portion of the first inflatable body <NUM> or the second inflatable body <NUM> being axially offset from the implant <NUM>.

With the inflatable bodies <NUM>, <NUM> in the deflated state as shown in <FIG>, the shoulder portion <NUM> of the first inflatable body <NUM> is positioned adjacent to the second end <NUM> of the expandable implant <NUM>. The shoulder portion <NUM> may comprise a protrusion extending radially outward from the elongate shaft <NUM> of the delivery apparatus. The shoulder portion <NUM> may accordingly maintain the position of the second end <NUM> of the expandable implant <NUM>, with the second end <NUM> of the expandable implant <NUM> impeded from sliding in a direction towards the inflatable body <NUM>. The shoulder portion <NUM> is configured to contact the second end <NUM> of the expandable implant <NUM> to impede movement in the direction towards the inflatable body <NUM>. The shoulder portion <NUM> may have a diameter that is greater than a diameter of the implant <NUM> as shown in <FIG>.

Further, as shown in <FIG>, the shoulder portion <NUM> of the second inflatable body <NUM> may be positioned adjacent to the first end <NUM> of the expandable implant <NUM>. The shoulder portion <NUM> may comprise a protrusion extending radially outward from the elongate shaft <NUM> of the delivery apparatus. The shoulder portion <NUM> may accordingly impede the first end <NUM> of the expandable implant <NUM> from sliding in a direction away from the first inflatable body <NUM>. The shoulder portion <NUM> may contact the first end <NUM> of the expandable implant <NUM> to impede movement in the direction away from the first inflatable body <NUM>. The shoulder portion <NUM> may have a diameter that is greater than a diameter of the implant <NUM> as shown in <FIG>.

In operation, the expandable implant <NUM> may be delivered to a desired location within a patient's body such as an implantation site while being positioned upon the second inflatable body <NUM>, and with the system <NUM> in the configuration shown in <FIG>. The elongate shaft <NUM> may be moved to the desired implantation site as shown, for example in <FIG>, or via another method as desired.

Upon the expandable implant <NUM> being delivered to a desired implantation site, or prior to such movement, the first inflatable body <NUM> may be inflated as shown in <FIG>. Referring to <FIG>, fluid may be passed through the inflation lumen <NUM> and into the interior chamber <NUM> of the first inflatable body <NUM>. The first inflatable body <NUM> may be in an inflated state, and may have an increased outer diameter <NUM> of the inflatable body <NUM>. The size of the shoulder portion <NUM> may further increase. Notably, the shoulder portion <NUM> may continue to maintain the position of the second end <NUM> of the expandable implant <NUM>, by continuing to impede movement of the second end <NUM> of the expandable implant <NUM> in a direction towards the first inflatable body <NUM>. The second end <NUM> of the expandable implant <NUM> may remain in contact with the surface of the shoulder portion <NUM>.

Upon the first inflatable body <NUM> being inflated, the second inflatable body <NUM> may be at least partially inflated. <FIG>, for example, illustrates the second inflatable body <NUM> in an inflated state, being partially inflated. Fluid may be passed through the inflation lumen <NUM> and into the interior chamber <NUM> of the second inflatable body <NUM> to inflate the second inflatable body <NUM>. Upon inflation, the shoulder portion <NUM> of the second inflatable body <NUM> may be configured to first inflate, with inflation continuing in a direction towards the first inflatable body <NUM>. The increased diameter of the shoulder portion <NUM> may impede movement of the first end <NUM> of the expandable implant <NUM> in a direction away from the first inflatable body <NUM>. Further, the tapered shape of the outer surface <NUM> of the second inflatable body <NUM> may cause the outer surface <NUM> to apply an expansion force against the expandable implant <NUM> causing the first end <NUM> of the expandable implant <NUM> to move towards the first inflatable body <NUM>.

As discussed in regard to <FIG>, the shoulder portion <NUM> may continue to maintain the position of the second end <NUM> of the expandable implant <NUM>, by continuing to impede movement of the second end <NUM> of the expandable implant <NUM> in a direction (as indicated with arrow <NUM> in <FIG>) towards the first inflatable body <NUM>. As such, the outer surface <NUM> of the first inflatable body <NUM> may continue to apply a force to the expandable implant <NUM>, with the shoulder portion <NUM> providing a resistive counter force that maintains the position of the second end <NUM> of the expandable implant <NUM>. The first inflatable body <NUM> accordingly may comprise a stopper to impede movement of the second end <NUM> of the expandable implant <NUM>. As discussed in regard to <FIG>, with the first end <NUM> of the expandable implant <NUM> being free to move towards the first inflatable body <NUM> and the second end <NUM> being maintained in position, the expandable implant <NUM> shortens in a direction towards the second end <NUM> upon being radially expanded. Such movement is further enhanced by the direction of taper of the outer surface <NUM>. The expandable implant <NUM> may be configured to expand radially outward and have the length <NUM> of the expandable implant <NUM> shorten in a direction towards the first inflatable body <NUM> when the outer surface <NUM> applies the expansion force to the expandable implant <NUM>.

The tapered shape of the outer surface <NUM> includes a narrow portion <NUM> having a diameter <NUM>. The diameter <NUM> of the first inflatable body <NUM> is greater than the diameter <NUM> of the narrow portion <NUM>, thus allowing the first inflatable body <NUM> to maintain the position of the second end <NUM> of the expandable implant <NUM>.

The second inflatable body <NUM> may continue to be inflated, with the expandable implant <NUM> radially expanded and a length of the expandable implant <NUM> continuing to shorten in a direction towards the second end <NUM> of the implant <NUM>. The expandable implant <NUM> may be radially expanded by inflating the second inflatable body <NUM>. <FIG>, for example, illustrates the second inflatable body <NUM> in a fully inflated state, with the expandable implant <NUM> shortened in a direction towards the first inflatable body <NUM>. The outer surface <NUM> continues to apply an expansion force upon the implant <NUM>. The shoulder portion <NUM> of the first inflatable body <NUM> continues to maintain a position of the second end <NUM> of the implant during radial expansion of the implant <NUM> by impeding movement of the second end <NUM> of the expandable implant <NUM> in a direction towards the first inflatable body <NUM>. The narrow portion <NUM> of the second inflatable body <NUM> has increased in size, yet remains smaller in diameter <NUM> than the diameter <NUM> of the first inflatable body <NUM>. The implant <NUM> may be fully deployed, and may have a tapered shape when radially expanded.

The axial position of the implant <NUM> upon the tapered outer surface <NUM> of the second inflatable body <NUM> defines the expansion diameter of the implant <NUM>. As such, with a defined position of the implant <NUM> upon the tapered outer surface <NUM>, the expansion diameter of the implant <NUM> may be known. The shape of outer surface <NUM> of the second inflatable body <NUM> may be defined to produce a desired tapered shape of the implant <NUM> upon expansion, as well as the expansion diameter of the implant <NUM>.

Upon the implant <NUM> being fully deployed, the inflatable bodies <NUM>, <NUM> may be deflated in a reverse sequence than shown in <FIG>. The inflatable bodies <NUM>, <NUM> and the elongate shaft <NUM> may be removed from the implantation site, with the deployed implant <NUM> remaining in position.

The system <NUM> as disclosed herein may provide a variety of benefits, including improved positioning of the implant <NUM> upon the inflatable body <NUM> and deployment of the implant <NUM> from the inflatable body <NUM>. The first inflatable body <NUM> may serve to impede movement of the second end <NUM> of the expandable implant <NUM> towards the first inflatable body <NUM>, thus defining a position of the second end <NUM> of the expandable implant upon deployment. As such, the second end <NUM> of the implant <NUM> may be aligned with the desired implantation site and will be impeded from moving undesirably proximally from this position. The implant <NUM> may be deployed with the position of the second end <NUM> of the implant being defined, thus reducing the possibility of undesired positioning of the implant <NUM> upon the inflatable body <NUM>. Further, undesired slippage or other undesired processes in the deployment process may be reduced.

<FIG> illustrates a perspective view of the system <NUM> in the configuration shown in <FIG>, with the expandable implant <NUM> excluded from view for clarity. The first inflatable body <NUM> is shown to have a bulb shape, and the second inflatable body <NUM> is shown to have a conical frustum shape.

Variations in the configuration of the system <NUM> may be provided as desired. <FIG>, for example, illustrates a side cross sectional view of an embodiment of the system in which the positions of the first inflatable body <NUM> and the second inflatable body <NUM> are reversed from the positions shown in <FIG> upon the elongate shaft <NUM> of the delivery apparatus. The second inflatable body <NUM> may be positioned proximal and the first inflatable body <NUM> may be positioned distal. Such a reversed configuration may allow for a different delivery orientation of the expandable implant <NUM> to the desired implantation site. For example, the wide end <NUM> of the expandable implant <NUM> may be positioned proximal and the narrow end <NUM> may be positioned distal. Such a reversed configuration may also allow for a different direction of delivery approach to the implantation site. For example, with regard to an aortic heart valve, one configuration may allow for a transvascular approach (e.g., over the aortic arch) and another reversed configuration may allow for a transapical approach. Various other approaches may be utilized for an implantation site as desired.

Other variations may be utilized. For example, <FIG> illustrates an embodiment in which an inflatable body <NUM> is not coupled to an adjacent inflatable body <NUM>. The inflatable body <NUM> may otherwise be configured similarly as the first inflatable body <NUM> shown in <FIG>, and the inflatable body <NUM> may otherwise be configured similarly as the second inflatable body <NUM> shown in <FIG>.

Other variations may include a configuration in which a single inflation lumen is utilized to inflate both the first inflatable body and the second inflatable body. The inflation lumen, for example, may include a valve or other device that may allow for selective inflation of the inflatable bodies. One or more inflation lumens may extend along the elongate shaft <NUM> and may be configured to inflate one or more of the first inflatable body or second inflatable body.

Other variations may include a configuration in which the first inflatable body and the second inflatable body are comprised of a unitary body. The first inflatable body, for example, may be made of a material that more easily inflates than the second inflatable body. Upon inflation, the first inflatable body may then inflate first, due to the relatively reduced force at which the first inflatable body inflates. As the first inflatable body reaches its maximum size, the resistance to inflation of the first inflatable body may increase, and thus the second inflatable body may begin to expand due to inflation. The second inflatable body may then inflate until it reaches its maximum size. In this manner, the first inflatable body and second inflatable body may utilize a single fluid chamber and a single inflation lumen may be utilized. The sequence of the first inflatable body being inflated first and the second inflatable body being inflated second may be maintained due to the different materials of the first inflatable body and the second inflatable body, or other configuration of the bodies.

In embodiments, portions of the first inflatable body and second inflatable body may be covered with materials. For example, coatings or other coverings may be positioned over the inflatable bodies. A coating may cover the outer surface of the second inflatable body, yet the outer surface may apply an expansion force to the expandable implant through the coating. Combinations of features across various embodiments and other variations may be utilized as desired.

The system may be utilized as part of a delivery system for the expandable implant. <FIG>, for example, illustrates a delivery apparatus <NUM> that may be utilized to deliver the expandable implant <NUM> to a location in a patient's body. The delivery apparatus <NUM> may include the elongate shaft <NUM>, which may have a distal portion <NUM> and a proximal portion <NUM>. The system <NUM> including the inflatable bodies <NUM>, <NUM> may be positioned on the distal portion <NUM> of the elongate shaft <NUM>. The elongate shaft <NUM> may include a nose cone <NUM>, which may couple to an interior shaft <NUM> of the elongate shaft <NUM> (as shown in <FIG>). The interior shaft <NUM> may comprise a guide wire lumen for a guide wire to extend through as the delivery apparatus <NUM> approaches an implantation site. The nose cone <NUM> may be positioned distal of the inflatable bodies <NUM>, <NUM>. In embodiments, the second inflatable body <NUM> may be positioned adjacent to the nose cone <NUM> (or the first inflatable body <NUM> may be positioned adjacent to the nose cone <NUM> in an embodiment as shown in <FIG>).

The proximal portion <NUM> of the elongate shaft <NUM> may be coupled to a housing in the form of a handle <NUM>. The handle <NUM> may be configured to be gripped by a user to control movement of the elongate shaft <NUM>. The delivery apparatus <NUM> may include an actuation mechanism <NUM> for actuating operation of the delivery apparatus <NUM>, which may include deflecting the elongate shaft <NUM> into a desired orientation. For example, the elongate shaft <NUM> may be configured to be flexible to deflect to the desired portion of the patient's body, and may be steerable with operation of the actuation mechanism <NUM>.

A proximal end of the delivery apparatus <NUM> may include a port <NUM> for passing fluid into and out of one or more of the inflation lumens <NUM>, <NUM>.

The configuration of the delivery apparatus may vary from the configuration shown in <FIG>. Other types of delivery apparatuses may be utilized than shown in <FIG>.

<FIG> illustrate an exemplary method of utilizing systems disclosed herein. Methods disclosed herein may vary from the steps shown in <FIG>. Referring to <FIG>, the systems may be utilized in the deployment of an expandable implant <NUM> that is a prosthetic heart valve. The prosthetic heart valve may comprise a prosthetic aortic heart valve, or in other embodiments may comprise another form of prosthetic heart valve such as a mitral, tricuspid, or pulmonary heart valve. The implant in other embodiments may be utilized for repair, which may comprise repair of a portion of a heart, including heart valve repair. The implant may comprise a "V" shaped implant as shown in <FIG> and <FIG>. The implant in other embodiments may comprise other forms of medical implants including stents, among others.

<FIG> illustrates a step in a method of replacing an aortic heart valve. A delivery apparatus <NUM> for example as shown in <FIG> may be utilized to approach the native aortic heart valve <NUM>. The elongate shaft <NUM> may be deflected to allow the "V" shaped implant <NUM> to approach the native aortic heart valve <NUM> through the aortic arch.

The inflatable bodies <NUM>, <NUM> may be in an orientation relative to each other as shown in <FIG>, with the first inflatable body <NUM> being positioned distal and the second inflatable body <NUM> being positioned proximal. Such an orientation may allow for an expansion of the implant <NUM> with the wide end of the "V" shaped implant positioned proximal and the narrow end of the implant positioned distal. The inflatable bodies <NUM>, <NUM> may be in a deflated state, for example as shown in <FIG>.

Referring to <FIG>, the system may be advanced to position the expandable implant <NUM> in the desired implantation location. The first inflatable body <NUM> may first be inflated to a diameter as described in regard to <FIG>. The first inflatable body <NUM> may include the shoulder portion <NUM> that may impede movement of the narrow end <NUM> of the implant <NUM> in the distal direction. As such, the narrow end <NUM> of the implant <NUM> may be aligned and positioned with a desired implantation location for the implant <NUM>.

Referring to <FIG>, upon the first inflatable body <NUM> being inflated and in the desired position, the second inflatable body <NUM> may then be subsequently inflated in a process as described in <FIG> and <FIG>. The implant <NUM> may be expanded and deployed to the implantation site, which is the native aortic valve <NUM> as shown in <FIG>. The implant <NUM> may be positioned between the leaflets of the native aortic valve <NUM>. The wide end <NUM> of the implant <NUM> may be positioned proximal and the narrow end <NUM> of the implant may be positioned distal.

The inflatable bodies <NUM>, <NUM> may then be deflated and removed from the patient's body. The expandable implant <NUM> may remain deployed within the patient's body at the implantation site as shown in <FIG>.

The steps of the method disclosed herein may be varied as desired. The steps may be utilized with other embodiments of systems disclosed herein. The delivery apparatus shown in <FIG> is disclosed as being utilized, however, other forms of delivery apparatuses may be utilized. The delivery apparatuses may be configured to deploy implants in the form of prosthetic heart valves, or may be configured to deploy the other forms of implants such as stents or filters, or diagnostic devices, among others.

The other forms of implants such as stents or filters, among others, may be configured similarly as the implants disclosed herein. For example, the implants utilized according to embodiments herein may have an angled interior profile as discussed herein, or may have other profiles as desired. The implants may be cylindrical and may have a uniform interior profile in embodiments, for example. The implants may be configured to expand radially outward from an axis that the implant surrounds, for example a longitudinal axis of the implant.

The delivery apparatus and apparatuses and the systems disclosed herein may be used in a variety of procedures, which may include transcatheter aortic valve implantation (TAVI). The delivery apparatus and the systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a patient's heart. In embodiments, the delivery apparatus may be utilized for mitral, tricuspid, and pulmonary replacement and repair as well. The delivery systems may be utilized in transcatheter percutaneous procedures, including transarterial procedures, which may be transfemoral or transjugular. Transapical procedures, among others, may also be utilized.

Methods as disclosed herein may be utilized in locations that do not utilize native valves, including a pulmonary artery and in the vena cava, among other locations (other arteries, blood vessels, or other vasculature of a patient's body, among other portions of a patient's body). An implant such as a stent or other form of implant may be delivered to such portions of the patient's body.

The user as disclosed herein may comprise a surgeon, physician, or other medical professional, among other users.

Features of embodiments may be modified, substituted, excluded, or combined.

In addition, the methods herein are not limited to the methods specifically described, and may include methods of utilizing the systems and apparatuses disclosed herein.

The steps of the method may be modified, excluded, or added to, with systems, apparatuses, and methods disclosed herein.

The features of the embodiments disclosed herein may be implemented independently of the delivery apparatuses, or independent of other components disclosed herein. The various apparatuses of the systems may be implemented independently.

In closing, it is to be understood that although aspects of the present specification are highlighted by referring to specific embodiments, one skilled in the art will readily appreciate that these disclosed embodiments are only illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular methodology, protocol, and/or reagent, etc., described herein. As such, various modifications or changes to or alternative configurations of the disclosed subject matter can be made in accordance with the teachings herein. Lastly, the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of systems, apparatuses, and methods as disclosed herein, which is defined solely by the claims.

Certain embodiments of systems, apparatuses, and methods are described herein, including the best mode known to the inventors for carrying out the same. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the systems, apparatuses, and methods to be practiced otherwise than specifically described herein.

Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term "about. " As used herein, the term "about" means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses an approximation that may vary, yet is capable of performing the desired operation or process discussed herein.

The terms "a," "an," "the" and similar referents used in the context of describing the systems, apparatuses, and methods (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the systems, apparatuses, and methods and does not pose a limitation on the scope of the systems, apparatuses, and methods otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of the systems, apparatuses, and methods.

Claim 1:
A system for expansion of an expandable implant (<NUM>) having a first end (<NUM>) and a second end (<NUM>), the system comprising:
a first inflatable body (<NUM>) having a first outer diameter (<NUM>) when in an inflated state; and
a second inflatable body (<NUM>) positioned adjacent to the first inflatable body (<NUM>) and having an outer surface (<NUM>) configured to apply an expansion force to the expandable implant (<NUM>), the outer surface (<NUM>) having a shape that tapers downward in a direction towards the first inflatable body (<NUM>) to a narrow portion (<NUM>) having a second outer diameter (<NUM>) that is less than the first outer diameter (<NUM>) when the second inflatable body (<NUM>) is in an inflated state;
wherein the first inflatable body (<NUM>) includes a shoulder portion (<NUM>) and wherein, when the first inflatable body is in a deflated state, the shoulder portion (<NUM>) is configured to contact the second end (<NUM>) of the expandable implant (<NUM>) to impede movement of the expandable implant (<NUM>) in a direction (<NUM>) towards the first inflatable body (<NUM>).