Patent Description:
The present invention relates to vascular interventional devices, and, more particularly, to a vascular device insertion system and apparatus.

Some vascular procedures require a placement of a guidewire in a blood vessel as an initial step in the vascular procedure. However, at times it may be difficult for the physician to manually manipulate the guidewire through a blood vessel, such as in regions where the blood vessel is partially or totally occluded.

What is needed in the art is a vascular device insertion system and apparatus, which may be used to aid in the insertion and placement of a guidewire and/or a vascular catheter in a blood vessel. <CIT> discloses an endoscope having a hollow shaft movable in longitudinal direction, for driving a processing tool.

The present invention provides a vascular device insertion system and apparatus, which may be used to aid in the insertion and placement of a guidewire and/or a vascular catheter in a blood vessel.

According to a first aspect, there is provided a vascular device insertion system according to claim <NUM>. The system includes a support catheter, an insertion module housing containing a motor, and a motor controller. The support catheter has a hub, a flexible elongate member that extends distally from the hub, and a catheter lumen that extends through the hub and the flexible elongate member. The motor has a hollow motor shaft arranged along a longitudinal axis. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongate opening that extends from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft is configured to couple to the hub of the support catheter. The elongate opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous passage. The motor controller is electrically coupled to the motor. The motor controller is configured to control the motor so as to rotationally oscillate the hollow motor shaft about the longitudinal axis and to in turn rotationally oscillate the support catheter.

An advantage of the present invention is that the rotational oscillation provided by the motor shaft to the support catheter aids in longitudinally advancing the guidewire through an occlusion in the blood vessel.

Another advantage of the present invention is that a longitudinal reciprocation may be applied to the motor coincident with the rotational oscillation, so as to both longitudinal reciprocate and rotational oscillate the support catheter in the blood vessel.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment 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 a vascular device insertion system <NUM> which generally includes a vascular device insertion apparatus <NUM> and a vascular device <NUM>. Vascular device <NUM> may be, for example, a support catheter <NUM>, and which may be accompanied by a guidewire <NUM> and/or a vascular catheter, such as for example, an ultrasonic catheter <NUM>. In <FIG>, vascular device <NUM> and support catheter <NUM> are arranged along a longitudinal axis <NUM>.

Support catheter <NUM> includes a hub <NUM>-<NUM> and a flexible elongate member <NUM>-<NUM> that extends distally from hub <NUM>-<NUM>. A catheter lumen <NUM>-<NUM> extends through hub <NUM>-<NUM> and flexible elongate member <NUM>-<NUM>, i.e., through an entirety of the length of support catheter <NUM>. Hub <NUM>-<NUM> includes a mounting aperture <NUM>-<NUM> that forms a proximal part of catheter lumen <NUM>-<NUM>. Mounting aperture <NUM>-<NUM> of hub <NUM>-<NUM> has an enlarged diameter relative to the diameter of the remainder of catheter lumen <NUM>-<NUM>, and in the present embodiment, mounting aperture <NUM>-<NUM> of hub <NUM>-<NUM> has a distally extending interior taper <NUM>-<NUM> (e.g., frustoconical). Flexible elongate member <NUM>-<NUM> has a distal end portion <NUM>-<NUM>.

Guidewire <NUM> has a first end <NUM>-<NUM> and a second end <NUM>-<NUM>. Guidewire <NUM> is typical of that known in the art, and may be, for example, a flexible metal cable or wire, such as a nitinol wire or cable.

In the embodiment of <FIG>, the vascular catheter, which in the present embodiment is ultrasonic catheter <NUM>, has a catheter proximal portion <NUM>-<NUM>, a catheter distal portion <NUM>-<NUM>, and a guidewire lumen <NUM>-<NUM>. Guidewire lumen <NUM>-<NUM> is configured, e.g., in size and shape, to receive guidewire <NUM>, such that the vascular catheter, e.g., ultrasonic catheter <NUM>, may be guided to the region of interest by advancing the vascular catheter over guidewire <NUM> in a distal direction <NUM>. In the present embodiment, ultrasonic catheter <NUM> may include a core wire <NUM>-<NUM> that is configured to transfer vibrational energy to a work head <NUM>-<NUM> at catheter distal portion <NUM>-<NUM>.

Vascular device insertion apparatus <NUM> includes an insertion module housing <NUM>, a motor <NUM>, a motor controller <NUM>, and a slider <NUM>. Motor <NUM> and motor controller <NUM> may be battery operated, and the battery may be contained in insertion module housing <NUM>.

Insertion module housing <NUM> includes a motor housing <NUM>-<NUM> and a base housing <NUM>-<NUM>. Motor housing <NUM>-<NUM> of insertion module housing <NUM> may include a chamber that contains and mounts motor <NUM>. Base housing <NUM>-<NUM> of insertion module housing <NUM> may include a chamber that contains and mounts motor controller <NUM>.

Motor <NUM> is slidably mounted to motor housing <NUM>-<NUM> of insertion module housing <NUM>, e.g., by rails, such that motor <NUM> is longitudinally movable along longitudinal axis <NUM> relative to insertion module housing <NUM>. Slider <NUM> may be mounted to a side wall <NUM>-<NUM> of insertion module housing <NUM>. Slider <NUM> is connected to motor <NUM> via a linkage <NUM>, such that a longitudinal movement of slider <NUM> in a proximal direction <NUM> or distal direction <NUM> causes a corresponding longitudinal movement of motor <NUM> in proximal direction <NUM> or distal direction <NUM>. Stated differently, slider <NUM> is configured to longitudinally reciprocate the motor <NUM> along longitudinal axis <NUM>, i.e., to alternatingly move in proximal direction <NUM> and distal direction <NUM>, by a reciprocating siding movement of slider <NUM> relative to insertion module housing <NUM>.

Insertion module housing <NUM> may further include a plurality of mounting features <NUM> for connection to an auxiliary device, as depicted in <FIG>. In the present embodiment, the plurality of mounting features <NUM> may be configured and arranged as a set of proximally extending posts, and the plurality of mounting features <NUM> may be magnetic. In the present embodiment, individual mounting features of the plurality of mounting features <NUM> are identified as mounting feature <NUM>-<NUM>, mounting feature <NUM>-<NUM>, and mounting feature <NUM>-<NUM>.

Motor <NUM> may be, for example, a DC-motor, such as a stepper motor. Motor <NUM> has a hollow motor shaft <NUM> arranged along longitudinal axis <NUM>. Hollow motor shaft <NUM> has a proximal end <NUM>-<NUM>, a distal end <NUM>-<NUM>, a distal end portion <NUM>-<NUM>, and an elongate opening <NUM>-<NUM>. Elongate opening <NUM>-<NUM> extends from proximal end <NUM>-<NUM> to distal end <NUM>-<NUM> along longitudinal axis <NUM>. Stated differently, elongate opening <NUM>-<NUM> extends through an entirety of the length of hollow motor shaft <NUM>. In the present embodiment, for example, elongate opening <NUM>-<NUM> may have the shape of a cylinder through an entirety of the length of hollow motor shaft <NUM>.

Distal end portion <NUM>-<NUM> of hollow motor shaft <NUM> is configured to couple to hub <NUM>-<NUM> of support catheter <NUM>. In the present embodiment, hollow motor shaft <NUM> has a distally extending exterior taper <NUM>-<NUM> that is sized and shaped to engage the distally extending interior taper <NUM>-<NUM> of hub <NUM>-<NUM> of support catheter <NUM> in a friction fit, so as to releasably connect hollow motor shaft <NUM> of motor <NUM> to hub <NUM>-<NUM> of support catheter <NUM>.

When distal end portion <NUM>-<NUM> of hollow motor shaft <NUM> is coupled to hub <NUM>-<NUM> of support catheter <NUM>, then elongate opening <NUM>-<NUM> of hollow motor shaft <NUM> and catheter lumen <NUM>-<NUM> of support catheter <NUM> together define a continuous passage <NUM> that longitudinally extends through the combination of support catheter <NUM> and hollow motor shaft <NUM> of motor <NUM>. Guidewire <NUM> may be located in, e.g., advanced through, continuous passage <NUM> defined by elongate opening <NUM>-<NUM> in hollow motor shaft <NUM> and catheter lumen <NUM>-<NUM> of support catheter <NUM>, wherein a first end portion <NUM>-<NUM> of guidewire <NUM> is proximal to proximal end <NUM>-<NUM> of hollow motor shaft <NUM>. Continuous passage <NUM> is configured, e.g., in size and shape, such that guidewire <NUM> may be freely movable, e.g., longitudinally, in continuous passage <NUM> by manual manipulation of first end portion <NUM>-<NUM> of guidewire <NUM>, such that second end <NUM>-<NUM> of guidewire <NUM> may distally extend from distal end portion <NUM>-<NUM> of support catheter <NUM>. As used herein, the term "freely movable" means to encounter non-substantial resistance to movement, wherein substantial resistance will result in buckling or bending of the member being longitudinally moved.

Alternatively, or supplemental to guidewire <NUM>, the vascular catheter, e.g., ultrasonic catheter <NUM>, may be located in continuous passage <NUM> defined by elongate opening <NUM>-<NUM> in hollow motor shaft <NUM> and catheter lumen <NUM>-<NUM> of support catheter <NUM>, wherein catheter proximal portion <NUM>-<NUM> of ultrasonic catheter <NUM> is proximal to proximal end <NUM>-<NUM> of hollow motor shaft <NUM>. Continuous passage <NUM> is configured, e.g., in size and shape, such that ultrasonic catheter <NUM> is freely movable, e.g., longitudinally, in continuous passage <NUM> by manual manipulation of catheter proximal portion <NUM>-<NUM> of ultrasonic catheter <NUM>, such that catheter distal portion <NUM>-<NUM> of ultrasonic catheter <NUM> may distally extend from distal end portion <NUM>-<NUM> of support catheter <NUM>.

Motor controller <NUM> is electrically coupled to motor <NUM>. For example, motor controller <NUM> may be electrically connected to motor <NUM> by an electrical cable <NUM>. Motor controller <NUM> is configured, e.g., through hardwired or programmable logic, to control motor <NUM> so as to rotationally oscillate hollow motor shaft <NUM> about longitudinal axis <NUM>, and to in turn rotationally oscillate support catheter <NUM>, e.g., alternatingly clockwise to counterclockwise. In embodiments where motor <NUM> is a stepper motor, for example, then motor controller <NUM> will be a stepper motor controller.

In one embodiment, for example, the rotational oscillation of hollow motor shaft <NUM> may be less than one full revolution of hollow motor shaft <NUM>, and optionally, may be variable as to the rotational extent. For example, the rotational oscillation of hollow motor shaft <NUM> may be variable between one-eighth revolution and one-half revolution, alternating between clockwise and counterclockwise rotational directions. In turn, support catheter <NUM> will also rotationally oscillate in accordance with the rotational oscillation of hollow motor shaft <NUM>.

While hollow motor shaft <NUM> of motor <NUM> and support catheter <NUM> are rotationally oscillated by motor <NUM> and/or longitudinally reciprocated by slider <NUM>, guidewire <NUM> may be manually manipulated and advanced by the user through continuous passage <NUM> formed by elongate opening <NUM>-<NUM> in hollow motor shaft <NUM> and catheter lumen <NUM>-<NUM> of support catheter <NUM>. For example, in a vascular procedure, the rotational oscillation and/or longitudinal reciprocation of distal end portion <NUM>-<NUM> of flexible elongate member <NUM>-<NUM> of support catheter <NUM> is intended to help advance second end <NUM>-<NUM> of guidewire <NUM> to pass through and extend beyond a vascular occlusion (partial or total) in a blood vessel.

Alternatively, or supplemental to guidewire <NUM>, the vascular catheter, such as ultrasonic catheter <NUM>, may be manually manipulated and advanced by the user through continuous passage <NUM> formed by elongate opening <NUM>-<NUM> in hollow motor shaft <NUM> and catheter lumen <NUM>-<NUM> of support catheter <NUM>. For example, in a vascular procedure, the rotational oscillation and/or longitudinal reciprocation of distal end portion <NUM>-<NUM> of flexible elongate member <NUM>-<NUM> of support catheter <NUM> may be used to help the user manually longitudinally advance work head <NUM>-<NUM> of catheter distal portion <NUM>-<NUM> of ultrasonic catheter <NUM> into engagement with, and to pass through, a vascular occlusion (partial or total) in a blood vessel.

Referring also to <FIG>, there is shown the vascular device insertion system <NUM> configured to include an ultrasonic system <NUM>. Ultrasonic system <NUM> includes an ultrasonic signal generator <NUM> and an ultrasonic device <NUM>.

Ultrasonic signal generator <NUM> is typical of that known in the art, and may be configured to generate an ultrasonic electrical signal in the form of an ultrasonic excitation signal, e.g., in a frequency range of <NUM>-<NUM>, that is supplied to ultrasonic device <NUM> via an excitation signal cable <NUM>.

In the present embodiment, ultrasonic device <NUM> includes a device housing <NUM>, an ultrasonic transducer <NUM>, and ultrasonic catheter <NUM>. Core wire <NUM>-<NUM> (see <FIG>) of catheter proximal portion <NUM>-<NUM> of ultrasonic catheter <NUM> is operatively coupled to ultrasonic transducer <NUM>, e.g., via a sonic coupler <NUM>. Device housing <NUM> contains ultrasonic transducer <NUM>, which is mounted internally to device housing <NUM>. Device housing <NUM> may be constructed as a handpiece configured to be held by a user, such as for example, wherein device housing <NUM> has an outer shape and size to facilitate being grasped by the user during a medical procedure, such as for example, a vascular occlusion related procedure.

Ultrasonic transducer <NUM> may be, for example, a piezoelectric-type transducer. Ultrasonic transducer <NUM> of ultrasonic device <NUM> is electrically connected to ultrasonic signal generator <NUM> by excitation signal cable <NUM>, and ultrasonic transducer <NUM> is configured to receive and convert the ultrasonic excitation signal generated by ultrasonic signal generator <NUM> into ultrasonic vibrational energy, which may be in a frequency range corresponding to that of the ultrasonic excitation signal generated by ultrasonic signal generator <NUM>. For example, if the frequency of the ultrasonic excitation signal generated by ultrasonic signal generator <NUM> and supplied to ultrasonic transducer <NUM> is <NUM>, then the vibrational frequency of the output of ultrasonic transducer <NUM> correspondingly may be <NUM>, which in turn is supplied to core wire <NUM>-<NUM> (see <FIG>) of ultrasonic catheter <NUM>. As more fully described above with respect to <FIG>, continuous passage <NUM> of vascular device insertion apparatus <NUM> is configured such that ultrasonic catheter <NUM> is movable in continuous passage <NUM> to distally extend from support catheter <NUM>.

Device housing <NUM> includes a plurality of mounting features <NUM>. The plurality of mounting features <NUM> of device housing <NUM> is configured to releasably connect to the plurality of mounting features <NUM> insertion module housing <NUM>, so as to releasably mount device housing <NUM> to insertion module housing <NUM>. In the present embodiment, the plurality of mounting features <NUM> may be configured and arranged as a set of proximally extending posts or post receptacles (e.g., apertures). In the present embodiment, individual mounting features of the plurality of mounting features <NUM> are identified as mounting feature <NUM>-<NUM>, mounting feature <NUM>-<NUM>, and mounting feature <NUM>-<NUM>, which are configured (e.g., in size, shape, and function) to releasably connect to mounting feature <NUM>-<NUM>, mounting feature <NUM>-<NUM>, and mounting feature <NUM>-<NUM>, respectively, of insertion module housing <NUM>.

In one embodiment, for example, the plurality of mounting features <NUM> of insertion module housing <NUM> and the plurality of mounting features <NUM> of device housing <NUM> may be configured and arranged to couple together by magnetic attraction. In one implementation, for example, the opposing pairs (e.g., mounting feature <NUM>-<NUM> paired with mounting feature <NUM>-<NUM>) of each of the plurality of mounting features <NUM> of insertion module housing <NUM> and the plurality of mounting features <NUM> of device housing <NUM> may be a magnet, such that the magnetic attraction is by a North Pole/South Pole magnetic arrangement, so as to facilitate the magnetic coupling of device housing <NUM> of ultrasonic device <NUM> to insertion module housing <NUM> of vascular device insertion apparatus <NUM>. In another implementation, for example, one of the mounting features of the opposed pairs of mounting features (e.g., mounting feature <NUM>-<NUM> paired with mounting feature <NUM>-<NUM>) may be magnetic while the other is (or includes) a magnetic material, such as iron, so as to facilitate the magnetic coupling of device housing <NUM> of ultrasonic device <NUM> to insertion module housing <NUM> of vascular device insertion apparatus <NUM>.

As device housing <NUM> is moved into engagement with insertion module housing <NUM>, ultrasonic catheter <NUM> longitudinally moves in continuous passage <NUM>, e.g., through elongate opening <NUM>-<NUM> of hollow motor shaft <NUM> and catheter lumen <NUM>-<NUM> of support catheter <NUM>, is longitudinally moved in distal direction <NUM>. In embodiments that include guidewire <NUM> in continuous passage <NUM>, then guidewire <NUM> may be received in guidewire lumen <NUM>-<NUM> (see <FIG>) of ultrasonic catheter <NUM>, such that ultrasonic catheter <NUM> moves distally through continuous passage <NUM> along guidewire <NUM> as ultrasonic catheter <NUM> is moved longitudinally in distal direction <NUM>.

The operation of vascular device insertion apparatus <NUM>, as depicted in <FIG>, will now be described with respect to a vascular procedure to locate guidewire <NUM> in a blood vessel of a patient. Support catheter <NUM> is connected to hollow motor shaft <NUM> of motor <NUM>, so as to establish continuous passage <NUM> of vascular device insertion system <NUM>. Support catheter <NUM> is inserted into a blood vessel of the patient, followed by the threading of guidewire <NUM> into elongate opening <NUM>-<NUM> (of hollow motor shaft <NUM>) that forms the initial portion of continuous passage <NUM> of vascular device insertion system <NUM>. Motor <NUM> is then actuated by motor controller <NUM> so that hollow motor shaft <NUM> of motor <NUM> and support catheter <NUM> (including distal end portion <NUM>-<NUM> of flexible elongate member <NUM>-<NUM> of support catheter <NUM>) are rotationally oscillated, in unison, so as to aid in the distal advancement of support catheter <NUM> through the blood vessel to the vascular occlusion site. Optionally, motor <NUM> and support catheter <NUM> also may be longitudinally displaced, e.g., reciprocated, by slider <NUM>, alone or in combination with the rotational oscillation. While hollow motor shaft <NUM> of motor <NUM> and support catheter <NUM> are rotationally oscillated, guidewire <NUM> is manually manipulated and advanced by the physician through the continuous passage <NUM> formed by elongate opening <NUM>-<NUM> in hollow motor shaft <NUM> and catheter lumen <NUM>-<NUM> of support catheter <NUM>, and second end <NUM>-<NUM> of guidewire <NUM> is advanced into engagement with the vascular occlusion in the blood vessel. The rotational oscillation and/or longitudinal reciprocation of distal end portion <NUM>-<NUM> of flexible elongate member <NUM>-<NUM> of support catheter <NUM> helps the physician to further advance second end <NUM>-<NUM> of guidewire <NUM> to pass through and extend beyond a vascular occlusion (partial or total) in the blood vessel.

With reference to <FIG> and <FIG>, after guidewire <NUM> is placed at the desired location in the blood vessel of the patient, first end <NUM>-<NUM> of guidewire <NUM> may then be threaded into and through guidewire lumen <NUM>-<NUM> of ultrasonic catheter <NUM> of ultrasonic device <NUM>, such that ultrasonic catheter <NUM> may be advanced distally through continuous passage <NUM> along guidewire <NUM> as ultrasonic catheter <NUM> is moved longitudinally in distal direction <NUM>. Ultrasonic signal generator <NUM> may then be energized to send the ultrasonic excitation signal to ultrasonic transducer <NUM>. Ultrasonic transducer <NUM> receives and converts the ultrasonic excitation signal into ultrasonic vibrational energy, which in turn is supplied to core wire <NUM>-<NUM> (see <FIG>) of ultrasonic catheter <NUM> so as to transmit vibrational energy to work head <NUM>-<NUM> which engages and bores into a proximal cap of the vascular occlusion.

While in some of the examples and embodiments above the structure and operation of vascular device insertion apparatus <NUM> has been described in terms of aiding insertion of a guidewire <NUM> in a blood vessel to a desired location, e.g., so as to guide the positioning of a vascular catheter, such as ultrasonic catheter <NUM>, it is to be understood that in some procedures vascular device insertion apparatus <NUM> may be used to aid in directly inserting the vascular catheter to a desired location in the blood vessel without using guidewire <NUM>, if desired.

The following items also relate to the invention:
In one form, the invention relates to a vascular device insertion system, which may be configured to advance a support catheter in a vessel to facilitate the positioning of an auxiliary device, such as a guidewire and/or an ultrasonic catheter. The system may comprise a support catheter that has a hub, a flexible elongate member that extends distally from the hub, and a catheter lumen that extends through the hub and the flexible elongate member. The support catheter may be arranged along a longitudinal axis. The system also may comprise an insertion module housing that may (be configured to) contain a motor that has a hollow motor shaft arranged along a longitudinal axis. In other words, the system may comprise the motor. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongate opening that may extend from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft may be configured to couple, e.g., in a direct connection, to the hub of the support catheter. The elongate opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous passage. A motor controller may be electrically coupled to the motor. The motor controller may be configured to control the motor so as to rotationally oscillate the hollow motor shaft about the longitudinal axis, and to in turn rotationally oscillate the support catheter. Hence, the system is configured such that the motor may (be configured to) rotationally oscillate the hollow motor shaft about the longitudinal axis, and in turn rotationally oscillate the support catheter. In other words, the hollow motor shaft and the support catheter may be (configured to be) rotationally oscillated in unison around the (common) longitudinal axis, by the motor.

In some embodiments, a slider may be coupled to the motor. The slider may be configured to longitudinally reciprocate the motor along the longitudinal axis.

In some embodiments, the system may be configured to facilitate a positioning of a guidewire. The guidewire has a first end and a second end. The guidewire may be located in the continuous passage defined by the elongate opening in the hollow motor shaft and the catheter lumen of the support catheter, wherein a first end portion of the guidewire may be proximal to the proximal end of the hollow motor shaft. The continuous passage may be configured such that the guidewire may be manually movable in the continuous passage to distally extend from the support catheter.

In some embodiments, the system may comprise an ultrasonic catheter that has a catheter proximal portion and a catheter distal portion. The ultrasonic catheter may be located in the continuous passage defined by the elongate opening in the hollow motor shaft and the catheter lumen of the support catheter, wherein the catheter proximal portion of the ultrasonic catheter may be proximal to the proximal end of the hollow motor shaft. The continuous passage may be configured such that the ultrasonic catheter may be movable in the continuous passage to distally extend from the support catheter.

In embodiments that include the ultrasonic catheter, the ultrasonic catheter may include a guidewire lumen configured to receive the guidewire.

In some embodiments, the system may comprise an ultrasonic device. The ultrasonic device may comprise an ultrasonic transducer, a device housing configured to contain the ultrasonic transducer, and an ultrasonic catheter that has a catheter proximal portion and a catheter distal portion. The catheter proximal portion may be operatively coupled to the ultrasonic transducer. The continuous passage may be configured such that the ultrasonic catheter may be movable in the continuous passage to distally extend from the support catheter.

In the embodiment of the previous paragraph, the ultrasonic catheter may have a guidewire lumen configured to receive a guidewire. The system may be configured such that the ultrasonic catheter may be guided through the continuous passage along the guidewire as the ultrasonic catheter is moved in a distal direction over the guidewire.

In the embodiments that include the insertion module housing and the device housing, the insertion module housing may include a first plurality of mounting features and the device housing may include a second plurality of mounting features. The first plurality of mounting features may be configured to releasably connect to the second plurality of mounting features to mount the device housing to the insertion module housing. The system may be configured such that the first plurality of mounting features may be configured to releasably connect to the second plurality of mounting features to mount the device housing to the insertion module housing.

In the embodiment of the previous paragraph, the first plurality of mounting features of the insertion module housing and the second plurality of mounting features of the device housing may be configured to form a magnetic connection, e.g., may be magnetic.

In some embodiments that include an ultrasonic transducer as a part of the system, the system may comprise an ultrasonic signal generator that may be electrically coupled to the ultrasonic transducer. The ultrasonic signal generator may be configured to supply an electrical excitation signal to the ultrasonic transducer.

In another form, the invention relates to a vascular device insertion system that may comprise a support catheter that has a hub, a flexible elongate member that extends distally from the hub, and a catheter lumen that extends through the hub and the flexible elongate member. An insertion module housing may be configured to contain a motor that has a hollow motor shaft arranged along a longitudinal axis. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongate opening that may extend from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft may be configured to couple to the hub of the support catheter. The elongate opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous passage. A guidewire has a first end and a second end, therein the guidewire may be located in the continuous passage defined by the elongate opening in the hollow motor shaft and the catheter lumen of the support catheter. A first end portion of the guidewire may be proximal to the proximal end of the hollow motor shaft. The continuous passage may be configured such that the guidewire may be freely manually movable in the continuous passage by manual manipulation of the first end portion of the guidewire. A motor controller may be electrically coupled to the motor. The motor controller may be configured to rotationally oscillate the hollow motor shaft about the longitudinal axis to in turn rotationally oscillate the support catheter. The features of par. [<NUM>] also apply to this form of the invention.

In some embodiments, a slider may be coupled to the motor, wherein the slider may be configured to longitudinally reciprocate the motor along the longitudinal axis.

In some embodiments, the system may comprise an ultrasonic device that may comprise an ultrasonic transducer, a device housing configured to contain the ultrasonic transducer, and an ultrasonic catheter that has a catheter proximal portion, a catheter distal portion, and a guidewire lumen. The catheter proximal portion may be operatively coupled to the ultrasonic transducer. The guidewire lumen may be configured to receive the guidewire. The system may be configured such that the ultrasonic catheter longitudinally moves in the continuous passage along the guidewire when the ultrasonic catheter is longitudinally moved.

In any of the embodiments that has the insertion module housing and the device housing, the insertion module housing may include a first plurality of mounting features and the device housing may include a second plurality of mounting features. The first plurality of mounting features may be configured to releasably connect to the second plurality of mounting features to mount the device housing to the insertion module housing.

In the embodiment according to the previous paragraph, the first plurality of mounting features of the insertion module housing and the second plurality of mounting features of the device housing may be configured to form a magnetic connection, e.g., may be magnetic.

In any of the embodiments that has the device housing, the device housing may be a handpiece configured to be held by a user.

In any of the embodiments that includes the ultrasonic transducer, the system may comprise an ultrasonic signal generator that may be electrically coupled to the ultrasonic transducer. The ultrasonic signal generator may be configured to supply an electrical excitation signal to the ultrasonic transducer.

In another form, the invention relates to a vascular device insertion apparatus that may be configured for (use in) advancing a support catheter and a guide wire in a vessel. The support catheter may have a hub, a flexible elongate member that extends distally from the hub, and a catheter lumen that extends through the hub and the flexible elongate member. The vascular device insertion apparatus may comprise an insertion module housing that is configured to contain a motor that has a hollow motor shaft arranged along a longitudinal axis. The hollow motor shaft may have a proximal end, a distal end, a distal end portion, and an elongate opening that may extend from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft may be configured to couple to the hub of the support catheter, wherein the elongate opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous passage. The continuous passage may be configured to receive the guidewire. A motor controller may be electrically coupled to the motor. The motor controller may be configured to rotationally oscillate the hollow motor shaft about the longitudinal axis to in turn rotationally oscillate the support catheter. This form of the invention is directed to the vascular device insertion system of par. [<NUM>], wherein the continuous passage may be configured to receive the guidewire. The features of par. [<NUM>] to [<NUM>] also apply to this form of the invention.

In any of the embodiments, the insertion module housing may optionally include a plurality of mounting features configured to mount to a device housing of an ultrasonic transducer.

As used herein, words of degree are relative modifiers intended to indicate permissible variation from the characteristic so modified. Such terms are not intended to be limited to the absolute value of the characteristic which it modifies, but rather possessing more of the physical or functional characteristic than the opposite.

Claim 1:
A vascular device insertion system (<NUM>), comprising:
a support catheter (<NUM>) having a hub (<NUM>-<NUM>), a flexible elongate member (<NUM>-<NUM>) that extends distally from the hub, and a catheter lumen (<NUM>-<NUM>) that extends through the hub and the flexible elongate member;
an insertion module housing (<NUM>) configured to contain a motor (<NUM>) having a hollow motor shaft (<NUM>) arranged along a longitudinal axis, the hollow motor shaft having a proximal end (<NUM>-<NUM>), a distal end (<NUM>-<NUM>), a distal end portion (<NUM>-<NUM>), and an elongate opening (<NUM>-<NUM>) that extends from the proximal end to the distal end along the longitudinal axis, the distal end portion of the hollow motor shaft configured to couple to the hub of the support catheter, and wherein the elongate opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous passage (<NUM>); and
a motor controller (<NUM>) electrically coupled to the motor, the motor controller configured to control the motor so as to rotationally oscillate the hollow motor shaft about the longitudinal axis, and to in turn rotationally oscillate the support catheter.