Patent Description:
The present invention relates to an endovascular apparatus.

Efforts continue in the endovascular art to improve the accuracy of placement of devices within a patient in performing invasive procedures and/or to traverse diseased tissue safely. <CIT> relates to a catheter system and method for achieving total cardiopulmonary bypass during heart surgery. <CIT> relates to systems, devices and methods for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments.

The present invention relates to the endovascular apparatus of independent claim <NUM> and the endovascular apparatus of independent claim <NUM>. Optional features are recited in the dependent claims.

The invention in one form is directed to an endovascular apparatus that includes a first cannula, a second cannula, and an operator handle. The first cannula has a proximal end, a distal end, and a first lumen. The second cannula is slidably coupled to the first cannula. The second cannula has a proximal end portion, a distal end portion, and a second lumen. The distal end portion is extendable in a distal direction beyond the distal end of the first cannula. An operator handle is operably coupled to the second cannula. The operator handle may be configured to articulate the distal end portion of the second cannula relative to the first cannula. The operator handle is for operation by an operator.

The second cannula may include an articulation joint. The operator handle may be configured to extend, retract, and rotate the second cannula relative to the first cannula.

An aspect not part of the presently claimed invention is directed to an endovascular apparatus having a first cannula, a second cannula, a guide wire, an intravascular device, and a magnetic coupler. The guide wire is located in the first lumen of the first cannula. The guide wire is configured to project from the distal end of the first cannula. The intravascular device is received in the second lumen of the second cannula. The intravascular device has a distal working portion that extends distally from the distal end portion of the second cannula. The magnetic coupler is configured to generate a passive magnetic bond between the guide wire and the distal working portion of the intravascular device.

An advantage of some embodiments is that the cannula having the ability to extend or retract, rotate, and articulate may be more precisely positioned within a patient.

Another advantage is that in embodiments that include the guide wire and the intravascular device that are magnetically coupled, the intravascular device tracks the guide wire without separating, such that diseased tissue can be traversed safely.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

Referring now to the drawings, and more particularly to <FIG>, there is shown an endovascular apparatus <NUM> which generally includes an operator handle <NUM> and a cannula arrangement <NUM>. Operator handle <NUM> is operably coupled to cannula arrangement <NUM>. Cannula arrangement <NUM> includes a first cannula <NUM>, a second cannula <NUM>, and an elongate sheath <NUM>.

First cannula <NUM> is formed as an elongate tube having a proximal end <NUM>-<NUM>, a distal end <NUM>-<NUM>, a lumen <NUM>-<NUM>, and an exterior surface <NUM>-<NUM>. First cannula <NUM> has a longitudinal extent between the proximal end <NUM>-<NUM> and the distal end <NUM>-<NUM>.

Second cannula <NUM> has a proximal end portion <NUM>-<NUM>, a distal end portion <NUM>-<NUM>, a lumen <NUM>-<NUM>, an exterior surface <NUM>-<NUM>, and an articulation joint <NUM>-<NUM>. Articulation joint <NUM>-<NUM> is interposed between proximal end portion <NUM>-<NUM> and distal end portion <NUM>-<NUM>. Lumen <NUM>-<NUM> extends through each of proximal end portion <NUM>-<NUM>, distal end portion <NUM>-<NUM>, and articulation joint <NUM>-<NUM>.

Articulation joint <NUM>-<NUM> is formed as a flexible tube, and may be formed, for example, from a flexible polymer, such as Pebax® polymer, or as a polymer encased nitinol tube.

Elongate sheath <NUM> is an elongate tube having a proximal end <NUM>-<NUM>, a distal end <NUM>-<NUM>, and a sheath lumen <NUM>-<NUM>. Elongate sheath <NUM> is configured to receive both of first cannula <NUM> and second cannula <NUM> in sheath lumen <NUM>-<NUM>.

In the present embodiment, first cannula <NUM> and second cannula <NUM> are positioned in sheath lumen <NUM>-<NUM> of elongate sheath <NUM>, such that second cannula <NUM> is slidably coupled to first cannula <NUM>. More particularly, second cannula <NUM> is slidable relative to first cannula <NUM> within sheath lumen <NUM>-<NUM> of elongate sheath <NUM>. In one implementation, first cannula <NUM> may be fixedly attached, e.g., by adhesive, to elongate sheath <NUM> within sheath lumen <NUM>-<NUM> such that first cannula <NUM> is longitudinally stationary relative to elongate sheath <NUM>, while second cannula <NUM> remains longitudinally movable within sheath lumen <NUM>-<NUM>. In another implementation, each of first cannula <NUM> and second cannula <NUM> may be longitudinally and independently movable within sheath lumen <NUM>-<NUM> of elongate sheath <NUM>; in other words, neither first cannula <NUM> nor second cannula <NUM> is fixedly attached to elongate sheath <NUM>.

In the present embodiment, exterior surface <NUM>-<NUM> of second cannula <NUM> is in sliding contact with exterior surface <NUM>-<NUM> of first cannula <NUM>. Distal end portion <NUM>-<NUM> of second cannula <NUM> is extendable in a distal direction <NUM> by a distance D1 beyond distal end <NUM>-<NUM> of first cannula <NUM>, i.e., is extendable beyond the longitudinal extent of first cannula <NUM>. Distance D1 is a variable distance, i.e., a distance wherein the distance amount may be selected by the user. In a preferred implementation, both of distal end portion <NUM>-<NUM> and articulation joint <NUM>-<NUM> of second cannula <NUM> are positioned by the user to extend beyond distal end <NUM>-<NUM> of first cannula <NUM>, such that distal end portion <NUM>-<NUM> of second cannula <NUM> may be freely articulated relative to first cannula <NUM> and elongate sheath <NUM>.

In the present embodiment, more particularly, operator handle <NUM> is operably coupled to the second cannula <NUM>. Operator handle <NUM> is configured to articulate distal end portion <NUM>-<NUM> of second cannula <NUM> relative to first cannula <NUM>. Also, operator handle <NUM> is configured to selectively rotate (clockwise or counterclockwise) second cannula <NUM> relative to the first cannula <NUM>. In addition, operator handle <NUM> is configured to selectively move second cannula <NUM> longitudinally relative to the first cannula <NUM> in each of a distal direction <NUM> and in a proximal direction <NUM>. Distal direction <NUM> and proximal direction <NUM> are opposite longitudinal directions.

Operator handle <NUM> includes a housing <NUM>, a hub <NUM>, and a translation member <NUM>. In the present embodiment, housing <NUM> is transparent to show hub <NUM> and the connections thereto. Housing <NUM> is configured as a hollow structure having a cavity <NUM>-<NUM> and a side slot <NUM>-<NUM>. Hub <NUM> is positioned in cavity <NUM>-<NUM> and is pivotably coupled to second cannula <NUM> via a pivot mechanism <NUM> at a pivot axis <NUM>. Pivot mechanism <NUM> may be formed, for example, as a pin/hole arrangement. Hub <NUM> has an operator lever <NUM>-<NUM> that loosely extends through side slot <NUM>-<NUM>, such that hub <NUM> is rotatably and slidably movable relative to first cannula <NUM> and housing <NUM>. Hub <NUM> also has an offset location <NUM>-<NUM> to define a proximal connection location for translation member <NUM>. Offset location <NUM>-<NUM> is laterally offset from pivot axis <NUM> so as to form a lever advantage.

Translation member <NUM> is an elongate member, such as a metal or plastic wire, that extends though lumen <NUM>-<NUM> of second cannula <NUM>. Translation member <NUM> has a proximal end <NUM>-<NUM> and distal end <NUM>-<NUM>. Proximal end <NUM>-<NUM> of translation member <NUM> is connected to hub <NUM> at offset location <NUM>-<NUM> by a fastener, such as a screw, clamp, weld, adhesive, etc. Distal end <NUM>-<NUM> of translation member <NUM> is connected to distal end portion <NUM>-<NUM> of second cannula <NUM> by a fastener, such as a screw, clamp, weld, adhesive, etc..

Hub <NUM> is axially movable within housing <NUM> along a rotational axis <NUM> in distal direction <NUM> to extend the second cannula <NUM> relative to the first cannula <NUM>, and hub <NUM> is axially movable along rotational axis <NUM> in proximal direction <NUM> to retract the second cannula <NUM> relative to the first cannula <NUM>. Hub <NUM> is rotatable within housing <NUM> about rotational axis <NUM> to rotate second cannula <NUM> within elongate sheath <NUM> relative to first cannula <NUM>. Also, hub <NUM> is pivotable within housing <NUM> about pivot axis <NUM> to articulate distal end portion <NUM>-<NUM> of the second cannula <NUM> by exerting a pulling (tension) force on translation member <NUM> in proximal direction <NUM> or a pushing force on translation member <NUM> in distal direction <NUM>, so as to selectively bend distal end portion <NUM>-<NUM> relative to proximal end portion <NUM>-<NUM> at articulation joint <NUM>-<NUM> to achieve the desired angular direction of distal end portion <NUM>-<NUM> relative to proximal end portion <NUM>-<NUM> of second cannula <NUM>.

Alternatively, in embodiments wherein articulation joint <NUM>-<NUM> includes a memory material, such as nitinol, and the relaxed state of articulation joint <NUM>-<NUM> is straight, then translation member <NUM> need only be capable of applying a pulling (tension) force, and articulation joint <NUM>-<NUM> will return to the relaxed (straight) state when the tension applied by translation member <NUM> is released. Thus, the amount of angle generated at articulation joint <NUM>-<NUM> is dependent, at least in part, upon the amount of tension applied by translation member <NUM>. Also, since in this implementation translation member <NUM> need only be capable of applying a pulling (tension) force, translation member <NUM> may be in the form of a thread, string, or wire.

Accordingly, when distal end portion <NUM>-<NUM> and articulation joint <NUM>-<NUM> are extended in a distal direction <NUM> beyond the distal end <NUM>-<NUM> of first cannula <NUM>, then second cannula <NUM> may be articulated at the articulation joint <NUM>-<NUM> by operation of hub <NUM> of operator handle <NUM>.

Referring to <FIG> and <FIG>, endovascular apparatus <NUM> may further include an intravascular device <NUM>, such as a core wire of an ultrasonic device, e.g., an ultrasonic core wire, received in the lumen <NUM>-<NUM> of the second cannula <NUM>. Intravascular device <NUM> has a distal working portion <NUM>-<NUM> that extends distally from the distal end portion <NUM>-<NUM> of second cannula <NUM>.

Referring to <FIG> and <FIG>, endovascular apparatus <NUM> may further include a guide wire <NUM> that is located in lumen <NUM>-<NUM> of first cannula <NUM>. Guide wire <NUM> may have a length sufficient such that guide wire <NUM> projects from each of proximal end <NUM>-<NUM> and distal end <NUM>-<NUM> of first cannula <NUM>.

Referring also to <FIG>, intravascular device <NUM> and guide wire <NUM> may be configured to form a magnetic coupler <NUM> that is configured to generate a passive magnetic bond between guide wire <NUM> and distal working portion <NUM>-<NUM> of intravascular device <NUM>. In embodiments wherein intravascular device <NUM> is an ultrasonic core wire, intravascular device <NUM> is configured to be coupled to an ultrasonic energy source to receive an ultrasonic vibrational wave and to transmit the ultrasonic vibrational wave to distal working portion <NUM>-<NUM>. The passive magnetic bond between guide wire <NUM> and distal working portion <NUM>-<NUM> of intravascular device <NUM> is broken when the ultrasonic vibrational wave (energy) is applied to intravascular device <NUM> by the ultrasonic energy source. It is contemplated that other types of mechanisms may be used to break the magnetic bond, so long as the mechanism generates a greater force than the attraction force of the selected magnet and ferromagnetic material.

In the embodiment shown in <FIG>, guide wire <NUM> has an attraction section <NUM>-<NUM> that extends from the distal end <NUM>-<NUM> of the first cannula <NUM>. Also, as shown in <FIG>, distal working portion <NUM>-<NUM> of intravascular device <NUM> has an attraction member <NUM>-<NUM>. Referring to <FIG>, at least one of attraction section <NUM>-<NUM> of guide wire <NUM> and attraction member <NUM>-<NUM> of intravascular device <NUM> has a magnet, e.g., a permanent magnet, to generate a magnetic force to magnetically bond distal working portion <NUM>-<NUM> of intravascular device <NUM> to attraction section <NUM>-<NUM> of guide wire <NUM>, and the other of attraction section <NUM>-<NUM> of guide wire <NUM> and attraction member <NUM>-<NUM> of intravascular device <NUM> is a ferromagnetic material, e.g., an iron alloy or a material that includes iron particles, that is magnetically attracted to the magnet.

Referring again to <FIG>, attraction section <NUM>-<NUM> of guide wire <NUM> may include a plurality of attraction elements <NUM> that are spaced along a longitudinal extent of guide wire <NUM>, wherein all of the plurality of attraction elements <NUM> is a respective magnet or all of the plurality of attraction elements <NUM> is a respective ferromagnetic material element. Each of the plurality of attraction elements <NUM> may form an annular band around guide wire <NUM>. It is contemplated that the plurality of attraction elements <NUM> may also serve as locator markings for identifying a location of guide wire <NUM> within a patient, or signifying a distance based on the spacing between adjacent pairs of the plurality of attraction elements <NUM>.

<FIG> are directed to another embodiment of a cannula arrangement <NUM> that may be used as an alternative to cannula arrangement <NUM> depicted in <FIG>. Thus, in the discussion that follows, it is to be understood that cannula arrangement <NUM> replaces cannula arrangement <NUM> in endovascular apparatus <NUM> of <FIG>. Cannula arrangement <NUM> has a sheath tube <NUM>, first cannula <NUM>, and second cannula <NUM>. Also, <FIG> shows a placement of translation member <NUM>, wherein translation member <NUM> is located inside lumen <NUM>-<NUM> of second cannula <NUM>. It is further contemplated that translation member <NUM> may be a formed as a plurality of pull wires, e.g., diametrically opposed at distal end portion <NUM>-<NUM>, to effect both a bending and straightening of second cannula <NUM>.

Sheath tube <NUM> has an exterior surface <NUM>-<NUM>, a guide lumen <NUM>-<NUM>, a proximal end <NUM>-<NUM>, and a distal end <NUM>-<NUM>. Proximal end <NUM>-<NUM> may be connected to operator handle <NUM> (see <FIG>). Distal end <NUM>-<NUM> may be beveled. Exterior surface <NUM>-<NUM> of sheath tube <NUM> is fixedly attached to exterior surface <NUM>-<NUM> of first cannula <NUM> along the longitudinal extent of first cannula <NUM>. Second cannula <NUM> is positioned in guide lumen <NUM>-<NUM> of the sheath tube <NUM> for slidable movement within the guide lumen <NUM>-<NUM> of sheath tube <NUM>. Distal end portion <NUM>-<NUM> and articulation joint <NUM>-<NUM> of second cannula <NUM> are extendable in distal direction <NUM> beyond the distal end <NUM>-<NUM> of sheath tube <NUM>. Second cannula <NUM> may be articulated at the articulation joint <NUM>-<NUM> by operation of operator handle <NUM>.

Referring to <FIG>, intravascular device <NUM> and guide wire <NUM> may be used with cannula arrangement <NUM> in the same manner as described above with respect to cannula arrangement <NUM>.

Alternatively, it is to be understood that embodiments that include intravascular device <NUM> and guide wire <NUM> may be practiced in the absence of the articulation features of the embodiments described with respect to <FIG>. Such alternative embodiments are not dependent on a particular cannula arrangement so long as attraction section <NUM>-<NUM> of guide wire <NUM> and attraction member <NUM>-<NUM> of intravascular device <NUM> are in proximity such that the magnetic bond may be formed between attraction member <NUM>-<NUM> at distal working portion <NUM>-<NUM> of intravascular device <NUM> and attraction section <NUM>-<NUM> of guide wire <NUM>.

Also, alternatively, it is contemplated to apply the magnetic coupling principles described above to cannula arrangement <NUM> of <FIG>, wherein first cannula <NUM> and second cannula <NUM> incorporate magnetic coupler <NUM>. More particularly, magnetic coupler <NUM> is configured to generate a passive magnetic bond between first cannula <NUM> and second cannula <NUM>. For example, first cannula <NUM> may include attraction member <NUM>-<NUM> at distal end <NUM>-<NUM>, and second cannula <NUM> may include an attraction element <NUM> at distal end portion <NUM>-<NUM>. In this configuration, the retractable second cannula <NUM> may be magnetically coupled to the fixed first cannula <NUM> when second cannula <NUM> is retracted to a pre-specific, e.g., zero, position. For example, the user may rotate or extend second cannula <NUM>, but once second cannula <NUM> is retracted close to the zero position, then second cannula <NUM> would magnetically snap back to the zero position by the attractive force of the passive magnetic field generated by magnetic coupler <NUM>. This would provide a tactile response to the user that they are at the pre-specified, e.g., zero, position.

The following items also relate to the invention:.

In one form, the invention relates to an endovascular apparatus having a first cannula, a second cannula, and an operator handle. The first cannula has a proximal end, a distal end, and a first lumen. The second cannula is slidably coupled to the first cannula. The second cannula has a proximal end portion, a distal end portion, and a second lumen. The distal end portion is extendable in a distal direction beyond the distal end of the first cannula. The operator handle is operably coupled to the second cannula. The operator handle is configured to articulate the distal end portion of the second cannula relative to the first cannula and/or to rotate (clockwise and/or counterclockwise) the second cannula relative to the first cannula and/or to selectively move the second cannula longitudinally relative to the first cannula. The endovascular apparatus is configured to articulate the distal end portion of the second cannula relative to the first cannula and/or to rotate (clockwise and/or counterclockwise) the second cannula relative to the first cannula and/or to selectively move the second cannula longitudinally relative to the first cannula, upon respective operation of the operator handle.

Optionally, the apparatus may include an elongate sheath that has a sheath lumen. Each of the first cannula and the second cannula may be positioned in the sheath lumen of the elongate sheath. The second cannula is slidable relative to the first cannula within the sheath lumen of the elongate sheath.

The first cannula may have a first exterior surface and the second cannula may have a second exterior surface. The second exterior surface of the second cannula may be in sliding contact with the first exterior surface of the first cannula.

Optionally, the apparatus may include a sheath tube that is fixedly attached to the first cannula along the longitudinal extent of the first cannula. The sheath tube may have a guide lumen, wherein the second cannula is positioned in the guide lumen of the sheath tube for slidable movement within the guide lumen of the sheath tube.

In any of the embodiments, the second cannula may have an articulation joint interposed between the proximal end portion and the distal end portion. The distal end portion and the articulation joint may be extendable in a distal direction beyond the distal end of the first cannula. The second cannula may be articulated at the articulation joint by operation of the operator handle.

In any of the embodiments, the operator handle may be configured to rotate the second cannula relative to the first cannula.

In any of the embodiments, the apparatus may include a translation member having a first end and a second end. The first end is attached to the distal end portion of the second cannula and second end is attached to the operator handle.

In any of the embodiments, the operator handle may be configured to extend the second cannula relative to the first cannula, to retract the second cannula relative to the first cannula, and/or to rotate the second cannula relative to the first cannula.

In any of the embodiments, the apparatus may include an intravascular device received in the second lumen of the second cannula. The intravascular device has a distal working portion that extends distally from the distal end portion of the second cannula.

In any of the embodiments, the apparatus may include a guide wire located in the first lumen of the first cannula. The guide wire may be configured to project from each of the proximal end and the distal end of the first cannula.

In any of the embodiments, the apparatus may include a guide wire, an intravascular device, and a magnetic coupler. The guide wire may be located in the first lumen of the first cannula. The guide wire may be configured to project from the distal end of the first cannula. The intravascular device may be received in the second lumen of the second cannula. The intravascular device has a distal working portion that extends distally from the distal end portion of the second cannula. The magnetic coupler is configured to generate a passive magnetic bond between the guide wire and the distal working portion of the intravascular device.

Optionally, the passive magnetic bond may be broken when vibrational energy is applied to the intravascular device.

In any of the embodiments, the apparatus may include a guide wire and an intravascular device. The guide wire may be located in the first lumen of the first cannula. The guide wire may be configured to project from each of the proximal end and the distal end of the first cannula. The guide wire may have an attraction section that extends from the distal end of the first cannula. The intravascular device may be received in the second lumen of the second cannula. The intravascular device may have a distal working portion that extends distally from the distal end portion of the second cannula. The distal working portion has an attraction member. At least one of the attraction section and the attraction member has a magnet to generate a magnetic force to magnetically bond the distal working portion of the intravascular device to the attraction section of the guide wire, and, optionally, the other of the attraction section and the attraction member is a ferromagnetic material that is magnetically attracted to the magnet.

The attraction section may include a plurality of attraction elements spaced along a longitudinal extent of the guide wire, wherein each of the plurality of attraction elements is one of a magnet and a ferromagnetic material.

Optionally, the attraction section may include a plurality of annular bands spaced along a longitudinal extent of the guide wire, wherein each of the plurality of annular bands is one of a magnet and a ferromagnetic material.

In another form, the invention relates to an endovascular apparatus having a first cannula, a second cannula, a guide wire, an intravascular device, and a magnetic coupler. The first cannula has a proximal end, a distal end, and a first lumen. The second cannula has a proximal end portion, a distal end portion, and a second lumen. The guide wire is located in the first lumen of the first cannula. The guide wire is configured to project from the distal end of the first cannula. The intravascular device is received in the second lumen of the second cannula. The intravascular device has a distal working portion that extends distally from the distal end portion of the second cannula. The magnetic coupler is configured to generate a passive magnetic bond between the guide wire and the distal working portion of the intravascular device. The endovascular apparatus is configured to generate a passive magnetic bond between the guide wire and the distal working portion of the intravascular device, by means of the magnetic coupler.

The intravascular device may be configured to be coupled to an ultrasonic source to receive a vibrational wave and to transmit the vibrational wave to the distal working portion, and wherein the passive magnetic bond may be broken when vibrational energy is applied to the intravascular device.

In any of the embodiments, the apparatus may include an operator handle operably coupled to the second cannula. The operator handle may be configured to articulate the distal end portion of the second cannula relative to the first cannula.

In any of the embodiments, optionally, the apparatus may include an elongate sheath having a sheath lumen. The first cannula and the second cannula may be positioned in the sheath lumen of the elongate sheath. The second cannula is slidable relative to the first cannula within the sheath lumen of the elongate sheath.

Alternatively, the apparatus may include a sheath tube fixedly attached to the first cannula along the longitudinal extent of the first cannula. The sheath tube has a guide lumen, wherein the second cannula may be positioned in the guide lumen of the sheath tube for slidable movement within the guide lumen of the sheath tube.

In any of the embodiments, the second cannula may have an articulation joint interposed between the proximal end portion and the distal end portion. The distal end portion and the articulation joint may be extendable in a distal direction beyond the distal end of the first cannula. The second cannula may be articulated at the articulation joint.

In any of the embodiments, an operator handle may operably be coupled to the second cannula, the operator handle configured to articulate the distal end portion of the second cannula relative to the first cannula and/or to rotate (clockwise and/or counterclockwise) the second cannula relative to the first cannula and/or to selectively move the second cannula longitudinally relative to the first cannula.

Claim 1:
An endovascular apparatus (<NUM>), comprising:
a first cannula (<NUM>) having a proximal end (<NUM>-<NUM>), a distal end (<NUM>-<NUM>), and a first lumen (<NUM>-<NUM>), wherein the first cannula (<NUM>) has a longitudinal extent between the proximal end (<NUM>-<NUM>) and the distal end (<NUM>-<NUM>);
a second cannula (<NUM>) slidably coupled to the first cannula (<NUM>), the second cannula (<NUM>) having a proximal end portion (<NUM>-<NUM>), a distal end portion (<NUM>-<NUM>), and a second lumen (<NUM>-<NUM>), the distal end portion (<NUM>-<NUM>) being extendable in a distal direction (<NUM>) beyond the distal end (<NUM>-<NUM>) of the first cannula (<NUM>); and
an operator handle (<NUM>) operably coupled to the second cannula (<NUM>), the operator handle (<NUM>) having a hub (<NUM>) pivotably coupled to the second cannula (<NUM>), the hub (<NUM>) configured to articulate the distal end portion (<NUM>-<NUM>) of the second cannula (<NUM>) relative to the first cannula (<NUM>); and
a sheath tube (<NUM>) fixedly attached to the first cannula (<NUM>) along the longitudinal extent, the sheath tube (<NUM>) having a guide lumen (<NUM>-<NUM>), wherein the second cannula (<NUM>) is positioned in the guide lumen (<NUM>-<NUM>) of the sheath tube (<NUM>) for slidable movement within the guide lumen (<NUM>-<NUM>) of the sheath tube (<NUM>).