Patent Description:
The invention is defined by independent claim <NUM> as well as subsequent dependent claims <NUM> - <NUM>.

The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. While various aspects of the embodiments are presented in drawings, the drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:.

The various embodiments disclosed herein generally relate to catheters. More specifically, the various embodiments relate to balloon catheter systems, for example, balloon catheter assemblies, fixed wire balloon catheter assemblies, and related methods. In some embodiments, the balloon catheter assembly comprises a hub, an elongated member, an inflation balloon, and a support wire. Also disclosed herein are methods of unpackaging, utilizing, and repackaging a balloon catheter assembly.

Balloon catheter assemblies may also comprise a sleeve, wherein the sleeve may be disposed within the hub of the balloon catheter assembly. A proximal end of the support wire may be displaceable within the sleeve. For example, during insertion of the balloon catheter assembly, the support wire may transition to a position wherein the proximal end of the support wire abuts a proximal end of the sleeve. During removal of the balloon catheter assembly, the support wire may transition to a position wherein the proximal end of the support wire is distally removed from the proximal end of the sleeve.

It will be appreciated that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another.

Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the drawings herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus is not intended to limit the scope of the disclosure, but is merely representative of possible embodiments of the disclosure. In some cases, well-known structures, materials, or operations are not shown or described in detail.

The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.

The terms "proximal" and "distal" refer to opposite ends of a medical device, including the devices disclosed herein. As used herein, the proximal portion of a medical device is the portion nearest a practitioner during use, while the distal portion is a portion at the opposite end. For example, the proximal end of a balloon catheter assembly is defined as the end closest to the practitioner during insertion or utilization of the balloon catheter assembly. The distal end is the end opposite the proximal end, along the longitudinal direction of the balloon catheter assembly.

<FIG> illustrates a balloon catheter assembly <NUM> according to one embodiment of the present disclosure. The balloon catheter assembly <NUM> comprises a hub <NUM>, an elongated member <NUM>, and an inflation balloon <NUM>. The elongated member <NUM> may be configured to provide a passageway for components and/or substances between at least the hub <NUM> and the inflation balloon <NUM>. For example, in the illustrated embodiment, a distal end <NUM> of the elongated member <NUM> is coupled to the balloon segment <NUM>, which comprises the inflation balloon <NUM>, and a proximal end <NUM> of the elongated member <NUM> is coupled to the hub <NUM>.

In the illustrated embodiment, the elongated member <NUM> comprises a lumen <NUM> extending longitudinally therethrough. For example, the lumen <NUM> can be configured to serve as a passageway through which an inflation fluid (e.g., a gas or a liquid) may be introduced into and/or withdrawn from the inflation balloon <NUM>. In such embodiments, the lumen <NUM> may be referred to as an inflation/deflation lumen. In some other embodiments, the elongated member <NUM> may comprise a plurality of lumens extending longitudinally therethrough.

In certain embodiments, the elongated member <NUM> comprises a polymeric material. The polymeric material may be extruded to form the elongated member <NUM> using one or more extrusion techniques. The elongated member <NUM> may also be referred to as catheter tubing, an elongated tubular member, a tubular member, or a first tubular member.

The inflation balloon <NUM> is disposed at a distal portion <NUM> of the balloon catheter assembly <NUM>. An interior of the inflation balloon <NUM> is in fluid communication with the lumen <NUM> of the elongated member <NUM> (i.e., the inflation/deflation lumen). For example, inflation fluid may flow between the inflation/deflation lumen <NUM> of the elongated member <NUM> and the inflation balloon <NUM>, or the interior thereof, during both inflation and deflation procedures, as discussed further below.

<FIG> is a cross-sectional view of the balloon catheter assembly <NUM> of <FIG>. As discussed above, the balloon catheter assembly <NUM> comprises the inflation balloon <NUM>, the elongated member <NUM>, and the hub <NUM>. As further shown, the proximal end <NUM> of the elongated member <NUM> is coupled to the hub <NUM>, and the distal end <NUM> of the elongated member <NUM> is coupled to the balloon segment <NUM>. The balloon catheter assembly <NUM> further comprises a support wire <NUM> and a sleeve <NUM>.

In some embodiments, the support wire <NUM> is at least partially disposed within the lumen <NUM> of the elongated member <NUM>. For example, in the illustrated embodiment, the support wire <NUM> extends longitudinally within the lumen <NUM> of the elongated member <NUM> and into the inflation balloon <NUM>, or the interior of the inflation balloon <NUM>. In such embodiments, the support wire <NUM> is configured to add increased rigidity and/or stiffness to the elongated member <NUM> and/or the inflation balloon <NUM>, which may aid in insertion of the balloon catheter assembly <NUM> into a delivery lumen (e.g., an endoscope) and/or a body lumen during use by a practitioner. As further illustrated, a distal end <NUM> of the support wire <NUM> may be coupled to, fixedly coupled to, or attached to the distal end <NUM> of the inflation balloon <NUM>. Also, as depicted, a proximal end <NUM> of the support wire <NUM> is at least partially disposed within the sleeve <NUM>. In some embodiments, the proximal end <NUM> of the support wire <NUM> may be operatively coupled to the hub <NUM> and/or the sleeve <NUM> such that the support wire <NUM> transfers distally oriented forces exerted on the hub <NUM> but not proximally oriented forces exerted on the hub <NUM> (i.e., distally and/or proximally oriented forces exerted by a practitioner on the hub <NUM> during use of the balloon catheter assembly <NUM>, such as during a medical procedure, as described in more detail below). In some other embodiments, the proximal end <NUM> of the support wire <NUM> can be fixedly coupled to the hub <NUM>. In various embodiments, the illustrated balloon catheter assembly <NUM> may be referred to as a fixed wire balloon catheter assembly, as the support wire <NUM> may not be configured, nor intended, to be removed from the balloon catheter assembly <NUM>.

The support wire <NUM> may be operatively coupled to the balloon catheter assembly <NUM> such that the support wire <NUM> does not exert a longitudinally compressive force on the inflation balloon <NUM> and such that the support wire <NUM> longitudinally supports the inflation balloon <NUM> when the inflation balloon <NUM> is subjected to longitudinally compressive forces. For example, the support wire <NUM> of the balloon catheter assembly <NUM> may be configured such that the inflation balloon <NUM> resists longitudinal compression upon insertion or passage of the inflation balloon <NUM> into or through a delivery lumen and/or a body lumen.

In the illustrated embodiment of <FIG>, the sleeve <NUM> is at least partially disposed within the hub <NUM> of the balloon catheter assembly <NUM>. In some embodiments, the sleeve <NUM> is coupled to, fixedly coupled to, retained within, or attached to an inside of the hub <NUM>. For example, the sleeve <NUM> may be partially disposed or embedded into an inner wall of the hub <NUM>. In other embodiments, the sleeve <NUM> is partially molded within an inner wall of the hub <NUM>. In yet other embodiments, a portion of the sleeve <NUM> is forcibly inserted into an inner wall of the hub <NUM>.

The sleeve <NUM> may comprise a hollow tubular structure. The distal end <NUM> of the sleeve <NUM> is open. In some embodiments, the proximal end <NUM> of the sleeve <NUM> is closed. For example, the proximal end <NUM> of the sleeve <NUM> may be crimped closed. In other embodiments, the proximal end <NUM> of the sleeve <NUM> may be open.

The sleeve <NUM> may comprise a rigid material, such as a metal material. In other embodiments, a hard polymeric material may be used. Other materials may also be used. In some embodiments, the sleeve <NUM> is about an inch (<NUM>) long; however, other lengths may also be used. For example, the sleeve <NUM> may be larger or smaller depending on the size and type of the catheter for which it is configured.

In some other embodiments, the balloon catheter assembly <NUM> may not comprise a sleeve <NUM>. For example, the proximal end <NUM> of the support wire <NUM> may be operatively coupled to the hub <NUM> at the lumen <NUM> of the hub <NUM> or at another position in or adjacent to the hub <NUM>.

<FIG> illustrates a cross-sectional view of an embodiment of a balloon catheter assembly that can, in certain respects, resemble components of the balloon catheter assembly described in connection with <FIG> and <FIG>. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to "<NUM>. " For instance, the inflation balloon is designated "<NUM>" in <FIG> and <FIG>, and an analogous inflation balloon is designated as "<NUM>" in <FIG>. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the balloon catheter assembly and related components shown in <FIG> and <FIG> may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the balloon catheter assembly of <FIG>. Any suitable combination of the features, and variations of the same, described with respect to the balloon catheter assembly and components illustrated in <FIG> and <FIG> can be employed with the balloon catheter assembly and components of <FIG>, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter.

The balloon catheter assembly <NUM> of <FIG> comprises an elongated member <NUM>. As illustrated, and as discussed above in reference to <FIG> and <FIG>, the elongated member <NUM> comprises a lumen <NUM> extending longitudinally through the elongated member <NUM>. A balloon segment <NUM> is coupled to a distal end <NUM> of the elongated member <NUM>. In various embodiments, the elongated member <NUM> and the inflation balloon <NUM> may be integrally formed. In other embodiments, the elongated member <NUM> and the inflatable balloon <NUM> may be separately formed. Further, a hub <NUM> is coupled to a proximal end <NUM> of the elongated member <NUM>. The balloon catheter assembly <NUM>, as depicted, also comprises a support wire <NUM> disposed within at least a portion of the elongated member <NUM>. The distal end <NUM> of the support wire <NUM> is coupled to a distal end <NUM> of the inflation balloon <NUM>. A proximal end <NUM> of the support wire <NUM> is disposed within at least a portion of the hub <NUM>, wherein the proximal end <NUM> of the support wire <NUM> is longitudinally displaceable within the hub <NUM>. In some examples, at least a portion of the proximal end <NUM> of the support wire <NUM> may be disposed within at least a portion of the hub <NUM> such that the support wire <NUM> does not transfer, or is not configured to transfer, a proximal longitudinal force to the inflation balloon <NUM>.

The distal end <NUM> of the support wire <NUM>, as depicted in <FIG>, is coupled to a distal end <NUM> of the inflation balloon <NUM>. Additionally, a coupling portion <NUM> of the support wire <NUM> is coupled to a proximal end <NUM> of the inflation balloon <NUM> and/or a distal end <NUM> of the elongated member <NUM>. In certain embodiments, the support wire <NUM> may also, or alternatively, be coupled to the inflation balloon <NUM> and/or the elongated member <NUM> at other positions. In such embodiments, the support wire <NUM> may resist, or be configured to resist, longitudinal compression of the inflation balloon <NUM>. Stated another way, the support wire <NUM> may be coupled to the inflation balloon <NUM> such that a longitudinal compression of the inflation balloon <NUM> is at least partially inhibited when the inflation balloon <NUM> is being inserted into or withdrawn from a delivery lumen and/or a body lumen. Coupling of the support wire <NUM> to at least each of the proximal end <NUM> and the distal end <NUM> of the inflation balloon <NUM> may longitudinally support the inflation balloon <NUM>, as the inflation balloon <NUM> in such a configuration cannot substantially be longitudinally compressed without deforming at least a portion or a segment of the support wire <NUM> disposed between each of the proximal end <NUM> and the distal end <NUM> of the inflation balloon <NUM>.

<FIG> is a detail view, taken through line 3B, of a portion of the balloon catheter assembly <NUM> of <FIG>. Referring to <FIG> and <FIG>, the coupling portion <NUM> of the support wire <NUM> can be disposed, or at least partially disposed, within a second tubular member <NUM>. In certain embodiments, the coupling portion <NUM> of the support wire <NUM> may be coupled, or fixedly coupled, to the second tubular member <NUM>. As depicted, the coupling portion <NUM> of the support wire <NUM> is coupled to the distal end <NUM> of the elongated member <NUM> via the second tubular member <NUM>. Additionally, in the illustrated embodiment, the second tubular member <NUM> extends to the distal end <NUM> of the inflation balloon <NUM>. The second tubular member <NUM> may be bonded to the proximal end <NUM> and the distal end <NUM> of the inflation balloon <NUM>, thus securing the support wire <NUM> to the proximal end <NUM> and the distal end <NUM> of the inflation balloon <NUM>. In other embodiments, the second tubular member <NUM> may be shorter and/or may be coupled to just the proximal end <NUM> of the inflation balloon <NUM> or the distal end <NUM> of the inflation balloon <NUM>. Any embodiment wherein the second tubular member <NUM> or support wire <NUM> is coupled to the proximal end <NUM> of the inflation balloon <NUM> may be altered such that these elements are coupled to the distal end <NUM> of the elongated member <NUM>. Further, embodiments wherein the second tubular member <NUM> is shorter, and only coupled to the proximal end <NUM> of the inflation balloon <NUM>, may further comprise another second tubular member, similar to the second tubular member <NUM>, which may be positioned at the distal end <NUM> of the support wire <NUM> and may aid in coupling of the distal end <NUM> of the support wire <NUM> to the distal end <NUM> of the inflation balloon <NUM>. Second tubular members may also be utilized at other positions wherein the support wire <NUM> is coupled to a component of the balloon catheter assembly <NUM>. Such embodiments may enhance or improve the coupling of the support wire <NUM> to the inflation balloon <NUM> compared to some other embodiments lacking a second tubular member <NUM>. For example, when the coupling portion <NUM> of the support wire <NUM> is directly coupled to the elongated member <NUM> and/or the inflation balloon <NUM>, only a portion of a circumferential surface area of the coupling portion <NUM> may be coupled to or in contact with the elongated member <NUM> and/or the inflation balloon <NUM>. In contrast, when the coupling portion <NUM> of the support wire <NUM> is disposed within the second tubular member <NUM>, a greater portion of the circumferential surface area, or substantially all of the circumferential surface area, of the coupling portion <NUM> can be coupled to or in contact with the second tubular member <NUM>. Further, the second tubular member <NUM>, due at least in part to its greater diameter relative to a diameter of the coupling portion <NUM>, may then have a larger circumferential surface area relative to the circumferential surface area of the coupling portion <NUM>, that may be coupled to or in contact with the elongated tubular member <NUM> and/or the inflation balloon <NUM>.

In certain embodiments, the second tubular member <NUM> may be coupled (e.g., bonded or welded) to the distal end <NUM> of the elongated member <NUM> and/or the proximal end <NUM> of the inflation balloon <NUM>. In various embodiments, the support wire <NUM> may comprise a first material, and the second tubular member <NUM> may comprise a second material. For example, the support wire <NUM> may comprise a metal material, and the second tubular member <NUM> may comprise a polymeric material, or vice versa. For example, the second tubular member <NUM> may comprise a polymeric material, such as PEBAX, nylon, etc. Other suitable materials are also contemplated.

In other embodiments, the support wire <NUM>, or the coupling portion <NUM> of the support wire <NUM>, may be directly coupled to the elongated member <NUM> and/or the inflation balloon <NUM>. For example, no second tubular member <NUM> may be present in some embodiments.

At least a portion of the support wire <NUM> and/or at least a portion of the second tubular member <NUM> may comprise one or more radiopaque markers <NUM>. For example, at least a portion of the second tubular member <NUM> may comprise a radiopaque marker band <NUM>. A radiopaque marker, such as the radiopaque marker bands <NUM>, may assist the practitioner in positioning the inflation balloon <NUM> at a target site (e.g., at the location of an obstructed vessel) within a body lumen during use of the balloon catheter assembly <NUM>. Also, in certain embodiments, a radiopaque marker, such as the radiopaque marker band <NUM>, may crimp or secure the second tubular member <NUM> to the support wire <NUM>. Additionally or alternatively the second tubular member <NUM> may be crimpled around the support wire <NUM> independently of a radiopaque maker band <NUM>.

Coupling of the support wire <NUM> at or adjacent to each of the proximal end <NUM> and the distal end <NUM> of the inflation balloon <NUM> can ease disposition or insertion of the inflation balloon <NUM> into or through a delivery lumen and/or a body lumen of a patient. The support wire <NUM>, in such embodiments, can stabilize and/or increase the rigidity of the inflation balloon <NUM>. During disposition of inflation balloons through delivery lumens and/or body lumens, the inflation balloons may tend to longitudinally fold or collapse (i.e., in the manner of an accordion) due to, for example, a longitudinally compressive force. The configuration of the support wire <NUM> and the inflation balloon <NUM> as disclosed herein may act to inhibit or limit such folding or collapsing of the inflation balloon <NUM> upon displacement of the inflation balloon <NUM> through a delivery lumen and/or a body lumen (i.e., to a position at or adjacent a target site).

As described in reference to <FIG> and <FIG>, the illustrated balloon catheter assembly <NUM> of <FIG> also comprises a sleeve <NUM> that is coupled to, fixedly coupled to, or attached to the inside of the hub <NUM> (i.e., at least partially disposed inside an inner wall of the hub <NUM>). Further, the proximal end <NUM> of the support wire <NUM> is disposed within at least a portion of the sleeve <NUM>, wherein the proximal end <NUM> of the support wire <NUM> is longitudinally displaceable within the sleeve <NUM>. In some embodiments, the proximal end <NUM> of the support wire <NUM> can abut, or be configured to abut, a proximal end <NUM> of the sleeve <NUM> when the inflation balloon <NUM> is being inserted into a delivery lumen and/or a body lumen (i.e., by a practitioner).

<FIG> and <FIG> illustrate the hub <NUM> of the balloon catheter assembly <NUM> of <FIG> in a first configuration and a second configuration, respectively. As shown, the sleeve <NUM> is at least partially disposed within the hub <NUM>. For example, the proximal end <NUM> of the sleeve <NUM> comprises a sharp point that has been inserted into an inner wall of the hub <NUM>. The proximal end <NUM> of the sleeve <NUM> is also closed. However, as previously stated, in other embodiments the proximal end <NUM> of the sleeve <NUM> could be open. In such embodiments, the open proximal end <NUM> of the sleeve <NUM> may abut material within the inner wall of the hub <NUM> to prevent proximal movement of the support wire <NUM> beyond the proximal end <NUM> of the sleeve <NUM>.

As further illustrated, the proximal end <NUM> of the sleeve <NUM> is disposed at an angle that is offset from a lumen <NUM> of the hub <NUM>. The sleeve <NUM> is also bent. In other embodiments, the sleeve <NUM> may be straight, or substantially straight. In such embodiments, the proximal end <NUM> of the straight, or substantially straight, sleeve <NUM> may be inserted into the inner wall of the hub <NUM>, for example, at an angle that is offset from the lumen <NUM> of the hub <NUM>.

As further illustrated in <FIG> and <FIG>, the distal end <NUM> of the sleeve <NUM> may extend distally into the proximal end <NUM> of the elongated member <NUM> and/or beyond the hub <NUM>. The distal end <NUM> of the sleeve <NUM> is open and the support wire <NUM> extends from within the elongated member <NUM> to the inside of the sleeve <NUM>. In the illustrated embodiment, the proximal end <NUM> of the support wire <NUM> is disposed within the sleeve <NUM>. The support wire <NUM> is not fixedly coupled to the sleeve <NUM>. Further, the support wire <NUM> is longitudinally displaceable within the sleeve <NUM>, as indicated by the reference arrows. For example, as the elongated member <NUM> is inserted into a delivery lumen and/or a body lumen, resistance on the elongated member <NUM> may cause the support wire <NUM> to transition or otherwise move proximally toward the proximal end <NUM> of the sleeve <NUM>. Once the support wire <NUM> abuts the proximal end <NUM> of the sleeve <NUM>, it is no longer proximally displaceable (see <FIG>). At this position, the support wire <NUM> may provide increased support and strength to the elongated member <NUM> during insertion into the delivery lumen and/or the body lumen.

After use, the inflation balloon may be deflated and the elongated member <NUM> may be withdrawn from the delivery lumen and/or the body lumen. In some instances, removal of the balloon catheter assembly requires force. For example, the deflated inflation balloon may have a tendency to catch or snag on introducer sheaths, scopes, and/or other insertion devices. The forces applied during removal may also cause the elongated member <NUM> to stretch. For example, the elongated member <NUM> may stretch longitudinally or otherwise become elongated in response to the removal forces that are being applied.

As the elongated member <NUM> elongates, the support wire <NUM>, which is coupled to the proximal end and/or the distal end of the inflation balloon, may transition and/or move distally within the sleeve <NUM>. For example, the support wire <NUM> moves distally from a position wherein the proximal end <NUM> of the support wire <NUM> is adjacent to, or closer to, the proximal end <NUM> of the sleeve <NUM>, as illustrated in <FIG>, to a position wherein the proximal end <NUM> of the support wire <NUM> is closer to the distal end <NUM> of the sleeve <NUM>, as illustrated in <FIG>. In other words, the proximal end <NUM> of the support wire <NUM> transitions to a position wherein it is distally, or more distally, spaced from the proximal end <NUM> of the sleeve <NUM>. In yet other embodiments, the proximal end <NUM> of the support wire <NUM> may distally move beyond the distal end <NUM> of the sleeve <NUM> such that the support wire is no longer disposed within the sleeve. The ability of the proximal end <NUM> of the support wire <NUM> to move distally during removal of the balloon catheter assembly alleviates and/or negates many complications that are encountered in the removal process.

In some embodiments, the proximal end <NUM> of the elongated member <NUM> may be fixedly coupled to the hub <NUM>, and the distal end <NUM> of the elongated member <NUM> may be fixedly coupled to the proximal end <NUM> of the inflation balloon <NUM>. Additionally, the proximal end <NUM> of the support wire <NUM> may not be fixedly coupled with the hub <NUM> (i.e., the proximal end <NUM> of the support wire <NUM> may be longitudinally displaceable within at least a portion of the hub <NUM> or sleeve <NUM>); however, the coupling portion <NUM> of the support wire <NUM> may be fixedly coupled to the distal end <NUM> of the elongated member <NUM> and/or the proximal end <NUM> of the inflation balloon <NUM>. In such a configuration, application of a proximal longitudinal force to the hub <NUM> may be transferred to at least the proximal end <NUM> of the inflation balloon <NUM> via the elongated member <NUM>, but the proximal longitudinal force may not be transferred to the inflation balloon <NUM> via the support wire <NUM>. Transfer of the proximal longitudinal force to the proximal end <NUM> of the inflation balloon <NUM> via the elongated member <NUM> may inhibit or resist longitudinal compression of the inflation balloon <NUM> upon proximal displacement of the inflation balloon <NUM> into or through a delivery lumen and/or body lumen.

In other embodiments the proximal end <NUM> of the support wire <NUM> may be fixedly coupled to the hub <NUM>, and the coupling portion <NUM> of the support wire <NUM> may be fixedly coupled to the proximal end <NUM> of the inflation balloon <NUM>. In such a configuration, application of a proximal longitudinal force to the hub <NUM> may be transferred via the support wire <NUM> to the proximal end <NUM> of the inflation balloon <NUM>, such that the proximal longitudinal force may be applied to the proximal end <NUM> of the inflation balloon <NUM> via the support wire <NUM>. Transfer of the proximal longitudinal force to the proximal end <NUM> of the inflation balloon <NUM> via the support wire <NUM> may also inhibit or resist longitudinal compression of the inflation balloon <NUM> upon proximal displacement of the inflation balloon <NUM> into or through a delivery lumen and/or body lumen. Configurations wherein the proximal longitudinal force is transferred from the hub <NUM> to the proximal end <NUM> of the inflation balloon <NUM> via both of the elongated member <NUM> and the support wire <NUM> are also within the scope of the present disclosure.

An illustrative method of positioning the balloon catheter assembly may comprise applying a force (i.e., by a practitioner during a medical procedure) to displace the balloon catheter assembly within a delivery lumen and/or a body lumen. The applied force can be transferred to or from the support wire such that the support wire does not exert a longitudinally compressive force on the inflation balloon. For example, as discussed above, in embodiments wherein the support wire is coupled to each of the distal end and the proximal end of the inflation balloon, the support wire can add increased rigidity and/or stiffness to the inflation balloon such that longitudinal compression of the inflation balloon may be inhibited or resisted. The method of positioning the balloon catheter assembly may further comprise deploying or inflating the inflation balloon at or adjacent to a target site. In some embodiments, the method may also comprise applying a proximal longitudinal force to the inflation balloon via the elongated member to retrieve the inflation balloon from the delivery lumen and/or the body lumen, wherein the proximal longitudinal force is not transferred to the inflation balloon via the support wire. Stated another way, the distal end of the support wire may be fixedly coupled to the inflation balloon, but the proximal end of the support wire may be longitudinally displaceable within the hub, as illustrated in <FIG> and <FIG>, such that a proximal longitudinal force may be applied to the inflation balloon via the elongated member but not via the support wire. In other embodiments, the method may comprise applying the proximal longitudinal force to a proximal end of the inflation balloon via the support wire. For example, the proximal end of the support wire may be fixedly coupled to the hub, and the coupling portion of the support wire may be fixedly coupled to the proximal end of the inflation balloon such that the proximal longitudinal force may be applied to the proximal end of the inflation balloon via the support wire.

<FIG> illustrate a portion of a balloon catheter assembly, according to another embodiment, not forming part of the present invention, of the present disclosure. As shown in <FIG>, in some embodiments, the balloon catheter assembly comprises a sheath or covering <NUM> that is configured to cover the balloon segment <NUM> when the inflation balloon <NUM> is in a packaged configuration. The sheath <NUM> may comprise various materials, including polymeric materials. In some embodiments, the proximal and/or distal end of the sheath <NUM> may be flared outwardly as desired.

In the packaged configuration, the inflation balloon <NUM> is in a folded and deflated state. The sheath <NUM> is configured to be longitudinally and/or axially displaceable along the balloon segment <NUM> and the elongated member <NUM>. As indicated by the reference arrow, a practitioner may remove the sheath <NUM> from the balloon segment <NUM> by sliding or otherwise moving the sheath <NUM> in the proximal direction along the elongated member <NUM>. With the sheath <NUM> disposed at a position that is proximal to the balloon segment <NUM>, the balloon segment <NUM> may be introduced into a body lumen and inflated. If desired, the practitioner can also remove the sheath <NUM> distally and off of the elongated member <NUM> entirely.

<FIG> and <FIG> illustrate the portion of the balloon catheter assembly of <FIG> in an unpackaged configuration, after the sheath <NUM> has been proximally removed from the balloon segment <NUM>. For example, the sheath <NUM> is disposed around the elongated member <NUM> at a location that is proximal to the balloon segment <NUM>. In <FIG>, the inflation balloon <NUM> is depicted in an inflated state. After the medical procedure is completed, the practitioner may deflate the inflation balloon <NUM>, as depicted in <FIG>. After the medical procedure is completed, the practitioner may also remove the balloon segment <NUM> from the body lumen. The sheath <NUM> can then be moved distally (e.g., slid) to a position that covers, or partially covers, the balloon segment <NUM> comprising the inflation balloon <NUM>, as indicated by the reference arrows.

<FIG> depicts the portion of the balloon catheter assembly of <FIG> in a repackaged configuration. In the repackaged configuration, the sheath <NUM> has been returned to a position wherein the sheath <NUM> is disposed around at least a portion of the balloon segment <NUM> and the inflation balloon <NUM>. For example, in the illustrated embodiment, the deflated inflation balloon <NUM> is compressed, crumpled, forced, or otherwise folded within the sheath <NUM>. If desired, the practitioner may remove the sheath <NUM> by proximally moving the sheath <NUM> along the elongated member <NUM> prior to a second medical procedure, as indicated by the reference arrow.

With continued reference to <FIG>, an illustrative method of employing the disclosed balloon catheter assembly may comprise a step of obtaining a packaged balloon catheter assembly, the packaged balloon catheter assembly comprising: an elongated member <NUM> having a distal end <NUM> that is coupled to a balloon segment <NUM>, comprising an inflation balloon <NUM>; and a sheath <NUM> disposed around the balloon segment <NUM>, the sheath <NUM> being longitudinally displaceable along the balloon segment <NUM> and the elongated member <NUM>. The method may further comprise a step of unpackaging the balloon catheter assembly, wherein unpackaging the balloon catheter assembly comprises longitudinally sliding the sheath <NUM> in a proximal direction to a position on the elongated member <NUM> that is proximal to the balloon segment <NUM>. The method may further comprise a step of repackaging the balloon catheter assembly, wherein repackaging the balloon catheter assembly comprises longitudinally sliding the sheath <NUM> in a distal direction to a position wherein the sheath <NUM> is disposed around at least a portion of the balloon segment <NUM>.

References to approximations are made throughout this specification, such as by use of the term "substantially. " For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as "about" and "substantially" are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term "substantially straight" is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely straight configuration.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim.

The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.

Claim 1:
A balloon catheter assembly (<NUM>, <NUM>), comprising:
an elongated member (<NUM>, <NUM>) having a lumen (<NUM>, <NUM>) extending longitudinally therethrough;
a hub (<NUM>, <NUM>) coupled to a proximal end (<NUM>, <NUM>) of the elongated member;
a sleeve (<NUM>, <NUM>), that is fixedly coupled to an inside of the hub;
a support wire (<NUM>, <NUM>) disposed within the elongated member; and
an inflation balloon (<NUM>, <NUM>);
wherein a distal end (<NUM>, <NUM>) of the inflation balloon is coupled to a distal end of the support wire (<NUM>, <NUM>), and wherein a proximal end of the support wire is disposed within the sleeve and the proximal end (<NUM>, <NUM>) of the support wire is longitudinally displaceable within the sleeve, the proximal end of the support wire being operatively coupled to the hub such that the support wire transfers distally oriented forces exerted on the hub but not proximally oriented forces exerted on the hub, and the support wire is operatively coupled to the balloon catheter assembly such that the support wire does not exert a longitudinally compressive force on the inflation balloon.