Patent Description:
<CIT> describes a system used to provide enhanced force to treat a lesion. This system has a flexible advancement member with a tracking member slidable over a guidewire, and a balloon having a distal end attached to the tracking member. This type of system provides limited focused force, and suffers from a lack of enhanced pushability (e. g, kink resistance) and maneuverability.

<CIT> discloses balloon catheter or stent delivery system for medical treatment of a patient has a proximal hub, a balloon, and an improved shaft design. The catheter shaft has a rapid-exchange configuration, and a tubular outer body that includes a hypotube extending from the catheter proximal end to a position at or near a proximal leg of the balloon.

The present invention is directed to the balloon catheter of claim <NUM>. The dependent claims refer to preferred embodiments.

According to an aspect of the disclosure, a balloon catheter is provided with enhanced pushability and maneuverability, by virtue of the omission of an internal guidewire and the inclusion of a support, such as a wire or tube, having one or more spiral cut or spring-like portions.

In one aspect, the disclosure pertains to a balloon catheter having a shaft with a proximal end section, a distal end section, and a support extending from the proximal end section to the distal end section of the shaft. At least a portion of the support comprises a spiral cut portion. A hub is mounted to the proximal end section of the shaft, and an inflatable balloon mounted on the distal end section of the shaft. At least one scoring wire is also provided, the at least one scoring wire having a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon.

In one embodiment, the support comprises a tube. The spiral cut portion of the tube may be located within the distal end section of the shaft, within the hub, or both. The support may alternatively comprise a wire, which may also be located within the distal end section of the shaft, the hub, or both.

The balloon catheter may include a spring for connecting the second end of the scoring wire to the proximal end section of the shaft. The at least one scoring wire may comprise two scoring wires, and the shaft may include a lumen for each scoring wire. The distal end section of the shaft includes a guidewire lumen having an inlet distal of the balloon and an outlet distal of the inflatable balloon.

According to a further aspect of the disclosure, a balloon catheter includes a shaft having a proximal end section, a distal end section, and a support extending from the proximal end section to the distal end section, at least a portion of the support comprising a spiral cut portion. A hub is mounted to the proximal end section of the shaft, and an inflatable balloon is mounted on the distal end section of the shaft, the distal end section of the shaft including a guidewire lumen having an inlet distal of the balloon and an outlet distal of the inflatable balloon. At least one scoring wire includes a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon.

In one embodiment, the second end of the at least one scoring wire is movably connected to the proximal end section of the shaft. The support may comprise a tube, with the spirally cut portion of the tube is located within the distal end section of the shaft or within the hub (or both). The support may alternatively comprise a wire, which may be similarly located.

According to claim <NUM>, the invention relates to a balloon catheter, comprising a shaft having a proximal end section, a distal end section, and a support wire extending from the proximal end section to the distal end section, at least a portion of the support wire comprising a spiral cut portion. A hub is mounted to the proximal end section of the shaft, and an inflatable balloon is mounted on the distal end section of the shaft.

In one optional embodiment, the balloon catheter includes at least one scoring wire having a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon. The second end is movably connected to the proximal end section of the shaft. A spring may also be provided for connecting the second end of the scoring wire to the proximal end section of the shaft. The at least one scoring wire may comprise two scoring wires, and the shaft may include a lumen for each scoring wire.

In one optional embodiment, the spirally cut portion of the support wire is located within the distal end section of the shaft. In another embodiment, the spirally cut portion of the support wire is located within the hub. The distal end section of the shaft may include a guidewire lumen having an inlet distal of the inflatable balloon and an outlet distal of the inflatable balloon.

The above and further advantages of the present invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which:.

The dimensions of some of the elements may be exaggerated relative to other elements for clarity or several physical components may be included in one functional block or element. Further, sometimes reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the blocks depicted in the drawings may be combined into a single function.

In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the present invention. The disclosed embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, components, or structures may not have been described in detail so as not to obscure the present invention.

The present disclosure is directed to systems and methods for treatment of a vessel. The principles and operation of systems and methods of the present invention may be better understood with reference to the drawings and accompanying descriptions.

The invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.

Certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.

The subject matter of the invention is defined by the appended claims.

Turning to the invention embodiments, <FIG> depicts an embodiment of the invention device. In this invention embodiment, a scoring balloon catheter <NUM> is shown in a front view with selected sections shown in a magnified view. The catheter <NUM> comprises comprises a shaft <NUM> with a shaft proximal section <NUM> connected to shaft middle section <NUM> and shaft middle section <NUM> connected to shaft distal section <NUM>. Shaft tapered section <NUM> joins shaft proximal section <NUM> to shaft middle section <NUM>. Shaft <NUM> also comprises shaft wall <NUM>, which provides a degree of rigidity to shaft <NUM> such that shaft <NUM> is suitable for tracking into vasculature or tortuous vasculature being neither too rigid or too flexible. Shaft <NUM> may comprise a polymeric material, such as Pebax.

In some embodiments, shaft tapered section <NUM> is fixed to shaft middle section <NUM>. In some embodiments, shaft wall <NUM> ends before shaft distal end or tip <NUM> ends. Shaft distal end <NUM> is the end of shaft <NUM> that enters the patient first, and may comprise a tip <NUM> comprising a lumen adapted for receiving a guidewire G. This creates a so-called "short rapid exchange" or "SRX" arrangement, which is one in which the guidewire G runs external to the catheter <NUM> and thus avoids the need for an internally extending guidewire and the associated complexities that may arise from the same.

The catheter <NUM> further comprises inflatable balloon <NUM>. Inflatable balloon <NUM> mounts to shaft <NUM> along shaft distal section <NUM>. In some embodiments, inflatable balloon <NUM> ends to shaft distal end <NUM>. In these or other embodiments, inflatable balloon <NUM> is fixed to shaft <NUM>.

Inflatable balloon <NUM> comprises inflatable balloon proximal end <NUM> and distal end <NUM>. A typical embodiment has a flexible, polymeric film serving as inflatable balloon <NUM> and having an outer surface <NUM>. For this disclosure, inflatable balloon proximal end <NUM> is the portion of inflatable balloon <NUM> that attaches or fixes the proximal end of inflatable balloon <NUM> to shaft <NUM>. Inflatable balloon proximal end <NUM> is defined as the proximal portion of inflatable balloon <NUM> that remains contacting shaft <NUM> after inflatable balloon <NUM> is inflated.

For this disclosure, inflatable balloon distal end <NUM> is the portion of inflatable balloon <NUM> that distally attaches or fixes inflatable balloon <NUM> to shaft <NUM>. Inflatable balloon distal end <NUM> is defined as the distal portion of inflatable balloon <NUM> that remains contacting shaft <NUM> after inflatable balloon <NUM> in inflated. An inflation lumen <NUM> fluidly communicates with inflatable balloon <NUM>, which allows inflatable balloon <NUM> to be inflated by fluid passing therethrough.

Catheter <NUM> further comprises hub <NUM>. Hub <NUM> resides inside of shaft <NUM> within shaft proximal section <NUM>. Hub <NUM> comprises a passage <NUM> for the support <NUM> to pass through. Hub <NUM> further comprises one or more hub lumens <NUM>.

Catheter <NUM> further comprises a support <NUM>, which may take the form of a solid wire or, according to an alternative not falling under the claimed invention, a hollow tube (such as, for example, a hypotube) and may be made of a metal (such as, for example, stainless steel gold, silver, platinum , titanium, or any other biocompatible metal or like material). The support <NUM> may extend longitudinally from at least from shaft proximal end <NUM>, such as from within hub <NUM>, to adjacent the shaft distal end or tip <NUM>. At least a portion of the support <NUM>, such as the portion located within the hub <NUM>, may be functionally modified to provide enhanced flexibility. This may be achieved by providing this portion of the support <NUM> with a spiral cut portion 119A, as indicated in <FIG>. This spiral cut portion 119A may be achieved, for example, by laser cutting, and essentially creates a spring-like portion of the support <NUM>. This helps to provide shaft <NUM> with sufficient rigidity in view of the lack of an internal guidewire, and thus improves trackability of the catheter <NUM>, while maintaining a high degree of pushability. As a result of the expandability provided, this feature also helps to avoid kinking, especially when the balloon is inflated and the shaft <NUM> diameter grows as a result.

Catheter <NUM> may further comprise one or more scoring wires <NUM>, with only one such wire shown in the embodiment of <FIG> running alongside of balloon <NUM> (with the guidewire G also extending alongside balloon so as to provide a scoring function). This scoring wire <NUM> may have a fixed end <NUM>, a section <NUM> extending alongside the balloon, and a movable end <NUM>. Fixed end <NUM> connects within shaft distal section <NUM> distal of the inflatable balloon distal end <NUM>. In some embodiments, fixed end <NUM> attaches to the outer side of shaft wall <NUM>. Fixed end <NUM> may be attached using any method known to those of ordinary skill in the art. This configuration provides for a focused force element (scoring wire <NUM>) alongside inflatable balloon <NUM>.

The distance between scoring wire <NUM> and outer surface <NUM> can be any value recognized as useful by those of ordinary skill in the art. Once past inflatable balloon <NUM>, scoring wire <NUM> may extend below shaft wall <NUM> and proximally inside of shaft <NUM>. Movable end <NUM> sits inside of shaft <NUM> within shaft proximal section <NUM>. In some embodiments, scoring wire <NUM> occupies at least part of lumen <NUM> (see <FIG>).

<FIG> depict catheter <NUM> as having two scoring wires, one of which is translatable scoring wire <NUM>, and the other of which is guidewire G. In some embodiments, catheter <NUM> has <NUM>-<NUM>, <NUM>-<NUM>, or <NUM>-<NUM> scoring wires. In some embodiments the diameter of scoring wire <NUM> is between <NUM> inches and <NUM> inches, or <NUM> inches and <NUM> inches, <NUM> inches and <NUM> inches. In some embodiments, scoring wire <NUM> is <NUM> inches. Scoring wire <NUM> need not have a uniform diameter, and may have a larger diameter at a distal end as compared to a proximal end. In some embodiments, scoring wire <NUM> comprises metals, metal alloys, polymers, and shape memory materials that are metal-based or polymer-based.

In some embodiments, the interaction encompasses movable scoring wire end <NUM> connected in or to hub lumen <NUM>. In some embodiments, movable scoring wire end <NUM> is fixed to hub lumen <NUM>. In other embodiments, the interaction encompasses movable scoring wire end <NUM> being slidably engaged inside of hub lumen <NUM>. In some embodiments hub <NUM> comprises any biocompatible material such as metals, metal alloys, and polymers. In some embodiments hub <NUM> comprises nylon, Pebax, or any other suitable material.

In some embodiments hub <NUM> is substantially fixed inside shaft proximal section <NUM> with movable scoring wire end <NUM> slidably engaged or disposed within hub lumen <NUM>. In some embodiments, hub <NUM> is longitudinally movable or elastic, allowing movable scoring wire end <NUM> to move longitudinally by pulling hub <NUM> distally, by moving hub <NUM> or by stretching material of hub <NUM>. For instance, in some embodiments, hub <NUM> is elastic. When movable scoring wire end <NUM> is subjected to a distally directed force that causes it to move distally and when movable scoring wire end <NUM> is fixed to or within hub lumen <NUM>, the movement stretches hub <NUM>. The restoring force or force counter to that distal stretching (counterforce) tends to move movable scoring wire end <NUM> substantially back into place when the distally directed force is removed.

Scoring wire catheter <NUM> may further comprises handle assembly <NUM>. Handle assembly <NUM> associates with shaft proximal end <NUM>. Handle assembly <NUM> may comprise a transition subassembly <NUM> including a stepped-down portion <NUM>, in which the overall outside dimension has a step transition decreasing to a smaller diameter, sized to engage shaft proximal end <NUM>. In some embodiments, transition subassembly <NUM> does not have stepped-down portion <NUM>.

Shaft <NUM> relates to handle assembly <NUM> through shaft proximal end <NUM> and stepped-down portion <NUM>. In some embodiments, shaft <NUM> connects to handle assembly <NUM>. For example, shaft proximal end <NUM> can slide over stepped-down portion <NUM> and the components can be fixed such as by welding, fusing, gluing, etc. The friction fit between shaft proximal end <NUM> and transition sub-assembly <NUM> can be strong enough to fix the components together. In some embodiments lacking stepped-down portion <NUM>, shaft proximal end <NUM> can connect to handle assembly <NUM> through a butt joint between shaft proximal end <NUM> and transition subassembly <NUM>.

The handle assembly <NUM> may comprise a port <NUM>. This port <NUM> carries gas or inflation fluid into inflatable balloon <NUM> via a lumen <NUM> to inflate it or carries gas or inflation fluid out of inflatable balloon <NUM> to deflate it.

Operationally, in the devices taught by the <FIG> embodiment, for treatment of calcified lesions, for example, a physician cuts through the patient's tissue until an appropriately sized vessel is revealed. The vessel must lead to the lesion site following a path that catheter <NUM> can follow. In some embodiments, the location of the lesion site may result in the selection of a more or less flexible shaft <NUM> or catheter <NUM>.

The physician opens the vessel, inserts a guidewire into the vessel, and advances the guidewire through the patient's vasculature under ultrasound, magnetic resonance, fluoroscopic, or some other type of guidance. Once the physician places the guidewire G at a satisfactory site, the physician threads the proximal end of the guidewire into the distal guidewire lumen associated with tip <NUM>, the entrance and exit of which lumen are distal of the balloon <NUM>. With the guidewire G in place and connected to catheter <NUM>, the physician maneuvers the catheter <NUM> along the guidewire G until inflatable balloon <NUM> reaches the desired position near the lesion site. Typically, this position will allow at least one scoring wire <NUM> to effectively engage the lesion. After that, the physician inflates inflatable balloon <NUM> until scoring wire <NUM> firmly presses into or cracks the lesion. Once lesion treatment with catheter <NUM> is complete, the physician deflates inflatable balloon <NUM>, which allows scoring wire <NUM> to relax away from the lesion and from the vessel wall.

Scoring wire <NUM> contacts the lesion as long as inflatable balloon <NUM> remains inflated. The inflation time corresponds to the time the physician chooses for scoring wire <NUM> to contact the lesion. Inflation times may range from <NUM> seconds to <NUM> minutes. The nature of the lesion may determine the appropriate inflation time and inflation speed.

As inflatable balloon <NUM> inflates, scoring wire (or wires) <NUM> expands outwardly, placing scoring wire <NUM> under longitudinal tension. A component of the force vector caused by that longitudinal tension points proximally from fixed end <NUM> and distally from movable end <NUM>. Therefore, any movement of scoring wire <NUM> occurs at movable end <NUM>. Hub <NUM> constrains the movement of movable end <NUM> allowing it to move longitudinally. This movement decreases the strain on inflatable balloon <NUM> helping to maintain its engineered shape and helping to avoid any kinking.

When the physician deflates the balloon <NUM>, the forces previously causing scoring wire <NUM> to expand disappear, allowing scoring wire <NUM> (and movable end <NUM>) to relax. Hub <NUM> constrains the relaxation of movable end <NUM>. Specifically, hub <NUM> guides movable end <NUM> into an arrangement similar to the initial arrangement of movable end <NUM> before balloon inflation. The action of hub <NUM> helps regularize the inflation and deflation steps increasing their predictability.

<FIG> is magnified view of shaft proximal section <NUM>. Shaft <NUM> ends at shaft proximal end <NUM> and receives hub <NUM>, which is either part of distal end <NUM> or not. Hub <NUM> can have one or more hub lumens <NUM> - <FIG> shows hub lumen <NUM>. The hub lumen <NUM> extends into hub <NUM> longitudinally in this embodiment. Catheter <NUM> does not need lengthwise hub lumen <NUM> to function correctly. Hub lumen <NUM> need only functions to slidably and reversibly receive movable end <NUM>. <FIG> shows hub lumen <NUM> extending into hub <NUM> approximately three quarters of the length of hub <NUM>, but this is not critical. In some embodiments, hub lumen <NUM> extends completely through hub <NUM>. Hub lumen <NUM> extends into hub <NUM> as far as or further than movable end <NUM> extends into hub lumen <NUM>.

<FIG> also shows scoring wire <NUM> and movable end <NUM>. In this embodiment, scoring wire <NUM> tapers or flares outwardly after proximally exiting lumen <NUM>. Movable end <NUM> occupies a portion of hub lumen <NUM>. In this embodiment, catheter <NUM> comprises one hub lumen <NUM> per movable end <NUM>, in case more than one scoring wire is present. Other embodiments exist in which a hub lumen can interact with more than one movable end <NUM>.

<FIG> depicts a magnified view of the region where scoring wire <NUM> distally exits lumen <NUM>. Scoring wire <NUM> has a path through part of catheter <NUM>. Lumen <NUM> is a lumen that receives scoring wire <NUM> along some or all of shaft middle section <NUM>. After exiting, scoring wire <NUM> flares outward as it progresses distally, extending in a substantially longitudinal direction until the wire is past the balloon distal end <NUM>. At that point scoring wire <NUM> turns inwardly until it reaches shaft distal section <NUM>. The scoring wire fixed end <NUM> attaches to catheter <NUM> distally of inflatable balloon <NUM> or at or near the point where balloon distal end <NUM> attaches to catheter <NUM>. The portion of scoring wire <NUM> within section <NUM> has a longitudinal region along inflatable balloon <NUM>.

In the operation of the group of embodiments represented by the device in <FIG>, a physician places inflatable balloon <NUM> as described above. The physician inflates inflatable balloon <NUM> through lumen port <NUM>. Balloon inflation first applies outward pressure on scoring wire <NUM> and guidewire G and forces the same to engage the lesion. Without wishing to be bound by any particular theory of operation, it is believed that, because movable end <NUM> is moveably connected, scoring wire <NUM> does not contribute to balloon or balloon deformation caused by inflation or overinflation. Since this wire <NUM> and guidewire G can move outwardly, their presence does not significantly cage the balloon, which prevents the balloon <NUM> from expanding past the wires. If inflation continues, some other portion of the balloon <NUM> will deform from the pressure exerted by the inflation fluid. In some cases, balloon deformation leads to problems with later deflating the balloon. Instead, the outwardly directed inflation pressure on scoring wire <NUM> causes movable end <NUM> to move distally, which lowers the counterforce that scoring wire <NUM> exerts against inflatable balloon <NUM>. As movable end <NUM> moves distally, it recedes from hub lumen <NUM>. In some embodiments, inflation pressure causes movable end <NUM> to pull out of hub lumen <NUM>. In other embodiments, movable end <NUM> remains inside of hub lumen <NUM>.

The physician maintains pressure in inflatable balloon <NUM> long enough for scoring wire <NUM> to have the desired effect. Afterward, the physician releases pressure, inflatable balloon <NUM> deflates, and movable end <NUM> re-extends into hub lumen <NUM>.

<FIG> depict a different embodiment of a scoring balloon catheter <NUM>, the main difference being the hub and the proximal scoring wire geometry. <FIG> depicts a hub <NUM> that has hub distal section <NUM> and hub proximal section <NUM>. Hub proximal section <NUM> through stepped-down portion <NUM> serves to connect shaft <NUM> with handle assembly <NUM>. Additionally, hub proximal section <NUM> serves as a stop for a spring <NUM>. Spring <NUM> comprises spring wire <NUM>, which adds resilience to the mechanism of scoring wire <NUM>.

Hub distal section <NUM> lies next to the distal end of spring <NUM>. Hub distal section <NUM> connects (attaches) to movable end <NUM>. In some embodiments, hub distal section <NUM> is fixed to movable end <NUM>. In other embodiments, hub distal section <NUM> comprises hub lumen <NUM>, which may be fixed to movable end <NUM>. Movable end <NUM> flares outwardly as it reaches hub distal section <NUM>. A guidewire G also extends through a guidewire lumen in the tip <NUM>, which is distal of the balloon distal end <NUM>.

As in the above embodiment, as inflatable balloon <NUM> inflates, the counterforce that scoring wire <NUM> would otherwise apply, is moderated by movable end <NUM>. Movable end <NUM> moves distally as before, but hub distal section <NUM> also moves distally. The arrangement of hub distal section <NUM>, spring <NUM>, and hub proximal section <NUM> imparts force, through hub distal section <NUM>, to movable end <NUM>. This force tends to proximally bias movable end <NUM>. And when the physician deflates the balloon as before, movable end <NUM> moves proximally, substantially back to its initial position, aided by the force of spring <NUM>.

<FIG> discloses an embodiment of the distal section of the catheter <NUM>. As indicated, the support <NUM> may extend the entire length of the balloon <NUM> to the tip <NUM> of the catheter <NUM>. This figure further shows that the portion of the support <NUM> extending along the balloon <NUM> may be functionally modified as noted above, such as by being formed of a spiral cut wire or tube, thus creating a spring-like portion. Again, this helps to provide shaft <NUM> with sufficient rigidity in view of the lack of an internal guidewire, and thus improves trackability of the catheter <NUM>, while maintaining a high degree of pushability.

<FIG> illustrates that, according to the invention, the support <NUM> comprises an elongated wire having a spiral cut portion 119A. While shown at the distal end, it can be appreciated that it may be located elsewhere, such as at the proximal end. More than one spiral cut portion, such as portion 119B, may also be provided. It can also be understood from <FIG> that the support <NUM> may have a length L, which may be at least as great as the distance D from the distal tip <NUM> of the catheter to the proximal end of the hub <NUM>, as indicated in <FIG>. <FIG> also shows that the support <NUM> when in the form of a wire has a solid cross-sectional area, save for the spiral cut portion 119A, but as noted above, in an alternative not falling under the claimed invention, the support may also comprise a hollow tube. In any case, the resulting portion 119A, 119B is spring-like and flexible as a result of being spirally cut as proposed.

<FIG> depicts section BB of <FIG>. It shows scoring wire <NUM>, guidewire G, inflatable balloon <NUM>, inflation lumen <NUM>, and support <NUM>. As can be seen, section plane BB cuts through catheter <NUM> at shaft distal section <NUM>. The plane also cuts inflatable balloon <NUM>; cuts scoring wire <NUM> at balloon section <NUM> showing cross-section <NUM>. <FIG> depicts a similar embodiment, but with two scoring wires <NUM> present, as well as guidewire G which may also provide scoring functionality.

<FIG> depicts section AA of <FIG>. It shows two lumens <NUM> in shaft <NUM> sitting side-by-side for receiving the scoring wires (not shown) if two are present. It also shows inflation lumen <NUM> and lumen <NUM> for receiving support <NUM> (wire or rod). Lumen <NUM> need not adopt a side-by-side configuration, as shown in this figure, but can adopt a configuration distributed around the perimeter of shaft <NUM>. A single lumen <NUM> may also be provided.

<FIG> shows a different embodiment with two lumens <NUM>, each for receiving a scoring wire (not shown) distributed across from each other in shaft <NUM>. This distribution need not be symmetric and, only one scoring wire may be present, in which case only one such lumen would be needed. Also in this figure, a lumen <NUM> for support lies within shaft <NUM>, and is coaxial with dual inflation lumens <NUM>.

In any of the embodiments set out above, inflatable balloon <NUM> can have any of a variety of diameters ranging from <NUM>-<NUM> or <NUM>-<NUM>. In any of the embodiments set out above, inflatable balloon <NUM> can have any of a variety of lengths such as <NUM>-<NUM> or <NUM>-<NUM>. Long balloons may be particularly useful for treating peripheral lesions, which often have long diseased portions.

Claim 1:
A balloon catheter (<NUM>), comprising:
a shaft (<NUM>) having a proximal end section (<NUM>), a distal end section (<NUM>), and a support wire (<NUM>) extending from the proximal end section (<NUM>) to the distal end section (<NUM>), at least a portion of the support wire (<NUM>) comprising a spiral cut portion (119A);
a hub (<NUM>) mounted to the proximal end section (<NUM>) of the shaft; and
an inflatable balloon (<NUM>) mounted on the distal end section (<NUM>) of the shaft.