Patent Description:
Medical devices may be used to perform surgical procedures, such as for example, a vascular occlusion crossing procedure or an atherectomy procedure, so as to restore patency and blood flow that was lost due to one or more intravascular occlusions. One type of medical device is an ultrasonic device configured to perform the vascular occlusion crossing procedure and/or the atherectomy procedure. A crossing procedure is a procedure in which an opening is formed through the intravascular occlusion. An atherectomy procedure may include crossing, but also attempts to break up and remove the intravascular occlusion. The ultrasonic device may include an ultrasonic catheter and a support catheter for performing the procedures.

What is needed in the art is an adjustable interface device that may be interposed between, and connected to, two components of a medical device, wherein the adjustable interface device has an adjustable length.

<CIT> discloses objects and features that may be generally noted in catheter systems to simplify and ease access to one or more target anatomies in various medical procedures, thereby reducing procedure time and associated costs.

<CIT> discloses a medical instrument which allows an operator to confirm the projecting state of an outer cylinder and an inner cylinder at hand of the operator. The medical instrument disclosed includes: an outer needle; an inner cylinder inserted into the outer needle; and a treatment implement inserted into the inner cylinder. The outer needle is movable between a first position where the tip is projected from the forward end of the inner cylinder and a second position where the tip is retreated from the forward end of the inner cylinder. The base end part of the inner cylinder is provided with a projection member projected in the radial direction and a turning member for the outer cylinder, which is supported on the projection member so as to be freely turnable and can come close to and separate from the outer peripheral surface of the outer needle. The base end part of the outer needle is provided with an engaging member which can be engaged with the turning member for the outer cylinder. The turning member for the outer cylinder includes: a first engagement part for holding the outer needle in the first position by engagement with the engaging member ; and a second engagement part for holding the outer needle in the second position by engagement with the engaging member.

<CIT> discloses a Dottering Auger Catheter system designed for penetration of tight stenoses or total occlusions (called blockages) as a precursor to balloon angioplasty, atherectomy, or any other vessel opening means that requires an initial passageway. Specifically, the Dottering Auger Catheter system consists of a centering catheter and a Dottering auger catheter which is a catheter that opens a passageway through an arterial blockage by passing its wedge shaped distal end through that blockage causing outward plastic deformation of the plaque; i.e., angioplasty. A centering catheter that surrounds the Dottering Auger Catheter can be used to center the distal end of the auger catheter just proximal to the blockage. The purpose of the auger type of Dottering catheter is to penetrate through the blockage by means of a self-tapping screw at the catheter's distal end. Once the first thread of the screw is pushed into the blockage, rotation of the catheter resulting from turning a handle at the catheter's proximal end will cause the screw to pull itself through the blockage while a push force on the handle is also applied. Once the auger has Dottered a passageway through the blockage, the auger catheter is removed and replaced with a guide wire. Once the guide wire is in place through the newly opened passageway, the centering catheter is removed and conventional balloon angioplasty or atherectomy can be performed to further enlarge the hole through the blockage thus restoring adequate blood flow.

The present invention provides an adjustable interface device that may be interposed between, and connected to, two components of a medical device, wherein the adjustable interface device has an adjustable length.

The invention, in one form, is directed to an adjustable interface device for connecting two components of a medical device for an occlusion crossing or atherectomy procedure. The adjustable interface device includes an elongate body,an elongate member and an adapter. The elongate body has a first end, a second end, an interior channel, and a side wall that surrounds the interior channel. The interior channel is configured to extend between the first end and the second end. The elongate body has a longitudinal axis that longitudinally extends through the interior channel. The side wall is configured to define a first connector portion adjacent the second end. The first connector portion has an annular recess and is configured to attach to a respective one of the two components of the medical device. The elongate member has a head end portion and a shaft portion that longitudinally extends from the head end portion. The shaft portion is located at least partially in the interior channel of the elongate body. The shaft portion is configured to slidably move axially along the longitudinal axis to adjust a length of the adjustable interface device. The head end portion defines a second connector portion configured to attach to the other of the two components of the medical device. The adapter has a threaded end portion and a snap-fit end portion. The snap-fit end portion has an annular protrusion configured for engagement with the annular recess of the connector portion of the elongate body.

The invention in another form is directed to an ultrasonic device that includes a handpiece, a support catheter and an adjustable interface device. The handpiece includes a handpiece housing, and an ultrasonic catheter connected to the handpiece housing. The handpiece housing is configured with an outer shape and size to facilitate being grasped by an operator. The ultrasonic catheter has a first mounting portion. The support catheter has a catheter body and a catheter sheath connected to the catheter body. The catheter body has a second mounting portion. The catheter sheath has a distal end. The adjustable interface device includes an elongate body,an elongate member and an adapter, according to the device described above.

An advantage of the present invention is that the adjustable interface device may be used, for example, to selectively and easily adapt the ultrasonic device for use in each of a crossing procedure and an atherectomy procedure.

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 medical system <NUM> in accordance with an embodiment of the present invention, which may be used for performing a medical procedure, such as an occlusion crossing and/or an atherectomy procedure.

In the present embodiment, for example, medical system <NUM> may include a console <NUM> and a medical device, such as for example, an ultrasonic device <NUM>. Referring also to <FIG>, ultrasonic device <NUM> includes a handpiece <NUM>, a support catheter <NUM>, and an ultrasonic catheter <NUM>. Support catheter <NUM> is detachably attached to handpiece <NUM> by an adjustable interface device <NUM>, in accordance with an aspect of the present invention.

In the present embodiment, as depicted in <FIG>, console <NUM> includes a user interface <NUM>, a controller <NUM>, and an ultrasonic energy source <NUM> located in user interface <NUM>. Console <NUM> may include multiple components in separate housing units, as in the embodiment shown, or may include the multiple components in a single housing unit. Optionally, console <NUM> also may include a foot switch <NUM>.

In the present embodiment, handpiece <NUM> includes a handpiece housing <NUM> and an ultrasonic transducer <NUM> mounted internally to handpiece housing <NUM>. Ultrasonic catheter <NUM> is mechanically connected to ultrasonic transducer <NUM>, and to handpiece housing <NUM>. Handpiece housing <NUM> has an outer shape and size to facilitate being grasped by an operator during a crossing or atherectomy procedure. Handpiece housing <NUM> includes at its distal end a mounting portion <NUM> configured to facilitate connection to ultrasonic catheter <NUM>.

Ultrasonic transducer <NUM> may be, for example, a piezoelectric-type transducer. Ultrasonic transducer <NUM> of handpiece <NUM> is electrically connected to ultrasonic energy source <NUM> by an electrical cable <NUM>. Ultrasonic transducer <NUM> is configured to receive and convert the ultrasonic electrical excitation signals generated by ultrasonic energy source <NUM> into ultrasonic vibrational energy, which may be in a frequency range corresponding to that of the ultrasonic electrical excitation signal generated by ultrasonic energy source <NUM>.

User interface <NUM> of console <NUM> is connected to controller <NUM> via an electrical cable <NUM>, e.g., a multi-wire cable or USB, to provide electrical and communication interconnection. Alternatively, user interface <NUM> may be a wireless link, e.g., Bluetooth, which is communicatively coupled to controller <NUM>. User interface <NUM> may include, for example, a touchscreen display <NUM> and associated input and output processing circuitry. Touchscreen display <NUM> may include, for example, a liquid crystal display (LCD) or a light-emitting diode (LED) display. Alternatively, user interface <NUM> may be in the form of a laptop computer or tablet. User interface <NUM> is configured to generate control signals based on user input received by touchscreen display <NUM>. For example, a user may operate touchscreen display <NUM> of user interface <NUM> to provide the control signals to controller <NUM> to initiate and/or terminate operation of ultrasonic energy source <NUM>.

Controller <NUM> is electrically connected and communicatively coupled to each of user interface <NUM> and ultrasonic energy source <NUM>. Controller <NUM> may include, for example, processor circuitry, interface circuitry, and electronic memory circuitry. Controller <NUM> is configured, for example, to execute program instructions to process signals received from touchscreen display <NUM> of user interface <NUM>, and to execute program instructions to provide output control signals to ultrasonic energy source <NUM> to control the operation of ultrasonic energy source <NUM>, such as for example, to control the frequency and/or electrical output power, of the ultrasonic electrical excitation signal generated by ultrasonic energy source <NUM>.

Ultrasonic energy source <NUM> is connected to ultrasonic transducer 36via an electrical cable <NUM>. Ultrasonic energy source <NUM> generates the ultrasonic electrical excitation signal that is delivered to ultrasonic transducer <NUM>. The frequency of the ultrasonic electrical excitation signal may be selectable, and or variable, in a range of <NUM> to <NUM>, for example. In some applications, for example, the ultrasonic frequency of the ultrasonic electrical excitation signal may be, or may initially be, at a frequency of <NUM>.

Foot switch <NUM> is connected to controller <NUM> via an electrical cable <NUM>. Foot switch <NUM> may provide auxiliary input signals to controller <NUM>, which in turn controller <NUM> may use to activate and deactivate system components, e.g., ultrasonic energy source <NUM> of medical system <NUM>.

Referring to <FIG> and <FIG>, support catheter <NUM> includes a catheter body <NUM>, a catheter sheath <NUM>, and a catheter lumen <NUM>. Catheter sheath <NUM> is connected to catheter body <NUM>. Catheter lumen <NUM> extends through an entirety of catheter body <NUM> and catheter sheath <NUM>. In the present embodiment, catheter body <NUM> and catheter sheath <NUM> may be formed as an integral unit, wherein a proximal end <NUM>-<NUM> catheter sheath <NUM> is permanently connected to catheter body <NUM>.

Catheter body <NUM> has a proximal end <NUM>-<NUM> that defines a proximal end of support catheter <NUM>. Catheter body <NUM> also includes, at proximal end <NUM>-<NUM>, a mounting portion <NUM> to facilitate connection to adjustable interface device <NUM>.

Catheter sheath <NUM> of support catheter <NUM> may be in the form of an elongate flexible tube, such as a polymer tube. Catheter sheath <NUM> of support catheter <NUM> includes proximal end <NUM>-<NUM> and a distal end <NUM>-<NUM>, and includes a portion of catheter lumen <NUM>. Distal end <NUM>-<NUM> of catheter sheath <NUM> defines a distal end of support catheter <NUM>. In the present embodiment, catheter lumen <NUM> is an elongate lumen that longitudinally extends through both of catheter body <NUM> and catheter sheath <NUM>, to distal end <NUM>-<NUM> of catheter sheath <NUM>, and may be formed as a central lumen, relative to the diameter, of catheter sheath <NUM>.

In the present embodiment, ultrasonic catheter <NUM> is an elongate member that includes a sheath that surrounds a flexible metal wire, e.g., nitinol. The sheath of ultrasonic catheter <NUM> is located in, and longitudinally extends within, catheter lumen <NUM> of catheter sheath <NUM> of support catheter <NUM>. In the present embodiment, ultrasonic catheter <NUM> may have a length greater than <NUM> centimeters (cm), and in some embodiments, for example, a length of <NUM> to <NUM>. Ultrasonic catheter <NUM> has a proximal end <NUM>-<NUM>, a distal tip <NUM>-<NUM>, a distal end portion <NUM>-<NUM>, and a handpiece <NUM>-<NUM>, wherein the sheath of ultrasonic catheter <NUM> longitudinally extends from handpiece <NUM>-<NUM>.

Proximal end <NUM>-<NUM> of ultrasonic catheter <NUM> is operably connected to ultrasonic transducer <NUM>, e.g., by a sonic connector, to receive the vibrational energy from ultrasonic transducer <NUM> so as to produce a vibrational motion of at least distal tip <NUM>-<NUM> of ultrasonic catheter <NUM>. The vibrational motion of ultrasonic catheter <NUM> may be longitudinal or a combination of longitudinal and transverse vibration.

Distal tip <NUM>-<NUM> of ultrasonic catheter <NUM> may be, for example, a blunt tip, e.g., a rounded tip, that is not pointed. In practice, catheter sheath <NUM> of support catheter <NUM> and ultrasonic catheter <NUM> are advanced into a blood vessel of the vasculature having a vascular occlusion, wherein distal tip <NUM>-<NUM> of ultrasonic catheter <NUM> engages the vascular occlusion.

Distal end portion <NUM>-<NUM> is the portion of ultrasonic catheter <NUM> that extends proximally from distal tip <NUM>-<NUM> of ultrasonic catheter <NUM>, and distal end portion <NUM>-<NUM> distally terminates at distal tip <NUM>-<NUM>.

Handpiece <NUM>-<NUM> of ultrasonic catheter <NUM> includes a mounting portion <NUM> to facilitate connection to adjustable interface device <NUM>.

Adjustable interface device <NUM> connects support catheter <NUM> to handpiece housing <NUM> of handpiece <NUM>. In the present embodiment, as depicted in <FIG> and <FIG>, adjustable interface device <NUM> is set to an intermediate length. <FIG> shows adjustable interface device <NUM> in a fully extended position <NUM>-<NUM>, and <FIG> shows adjustable interface device <NUM> in a fully retracted position <NUM>-<NUM>. A length of adjustable interface device <NUM> is adjustable between the fully extended position <NUM>-<NUM> and the fully retracted position <NUM>-<NUM> to accommodate both crossing and atherectomy procedures.

Referring again particularly to <FIG> and <FIG>, an adjustment of a length of adjustable interface device <NUM> in turn adjusts a position of distal end <NUM>-<NUM> of catheter sheath <NUM> relative to the distal tip <NUM>-<NUM> of ultrasonic catheter <NUM>, so as to adjust an amount of distal end portion <NUM>-<NUM> of ultrasonic catheter <NUM> that extends distally from distal end <NUM>-<NUM> of catheter sheath <NUM>. For example, in the fully extended position <NUM>-<NUM> of adjustable interface device <NUM>, distal end portion <NUM>-<NUM> of ultrasonic catheter <NUM> may be wholly disposed within the catheter lumen <NUM> of catheter sheath <NUM>. In the fully retracted position <NUM>-<NUM> of adjustable interface device <NUM>, distal tip <NUM>-<NUM> of ultrasonic catheter <NUM> will extend a maximum distance, e.g., <NUM> centimeters (cm), from distal end <NUM>-<NUM> of catheter sheath <NUM>, such that the entirety of distal end portion <NUM>-<NUM> of ultrasonic catheter <NUM> is exposed beyond distal end <NUM>-<NUM> of catheter sheath <NUM> of support catheter <NUM>.

Advantageously, adjustable interface device <NUM> provides more support to distal tip <NUM>-<NUM> of ultrasonic catheter <NUM> when extended, and adjustable interface device <NUM> provides more freedom to advance distal tip <NUM>-<NUM> of ultrasonic catheter <NUM> relative to support catheter <NUM> when retracted. Also, adjustable interface device <NUM> provides a general benefit of moving both support catheter <NUM> and ultrasonic catheter <NUM> as a unit during a procedure.

Referring to <FIG>, adjustable interface device <NUM> includes an elongate body <NUM> and an elongate member <NUM>. In the present embodiment, elongate member <NUM> is slidably and rotationally disposed in elongate body <NUM>. A length of adjustable interface device <NUM> is adjusted by longitudinally sliding elongate member <NUM> relative to elongate body <NUM>. In the present embodiment, after a desired length of adjustable interface device <NUM> is set, then the length of adjustable interface device <NUM> may be locked by rotating elongate member <NUM> relative to elongate body <NUM>, e.g., by a one-sixteenth to one-quarter turn of rotation of elongate member <NUM> relative to elongate body <NUM>.

Elongate body <NUM> includes a first end <NUM>-<NUM>, a second end <NUM>-<NUM>, a side wall <NUM>-<NUM>, and an interior channel <NUM>-<NUM>. Side wall <NUM>-<NUM> radially surrounds interior channel <NUM>-<NUM>. Interior channel <NUM>-<NUM> extends between first end <NUM>-<NUM> and second end <NUM>-<NUM> of elongate body <NUM>. Elongate body <NUM> has a longitudinal axis <NUM> that longitudinally extends through interior channel <NUM>-<NUM>. Side wall <NUM>-<NUM> is configured to define a first connector portion <NUM> adjacent the second end <NUM>-<NUM>. First connector portion <NUM> of elongate body <NUM> is configured to attach to a respective one of mounting portion <NUM> of handpiece <NUM>-<NUM> of ultrasonic catheter <NUM> or mounting portion <NUM> of support catheter <NUM>, depending on an orientation of adjustable interface device <NUM> relative to handpiece <NUM>-<NUM> of ultrasonic catheter <NUM> and support catheter <NUM>.

As best shown in <FIG>, for ease of assembly, elongate body <NUM> is configured as a split housing having a pair of separable housing portions, namely, housing portion <NUM>-<NUM> and housing portion <NUM>-<NUM>, wherein housing portion <NUM>-<NUM> and housing portion <NUM>-<NUM> are connected together by sets of longitudinally spaced hook-latch members <NUM>-<NUM>.

Referring also to <FIG> and <FIG>, in the present embodiment, first connector portion <NUM> of elongate body <NUM> is configured to attach to mounting portion <NUM> of the support catheter <NUM>. Also, referring to <FIG> and <FIG>, in the present embodiment, first connector portion <NUM> of elongate body <NUM> and mounting portion <NUM> of the support catheter <NUM> is configured to form a screw-type coupling, e.g., a Luer connection. For example, first connector portion <NUM> of elongate body <NUM> may be configured as a female threaded portion <NUM>-<NUM> and mounting portion <NUM> of the support catheter <NUM> may be configured as a male threaded portion, or vice-versa.

<FIG> show an interference, e.g., snap fit, connection as an alternative to the configuration of the embodiment depicted in <FIG> and <FIG> that depict the screw-type coupling, e.g., a Luer connection, for connecting first connector portion <NUM> of elongate body <NUM> to mounting portion <NUM> of the support catheter <NUM>. <FIG> show that first connector portion <NUM> of elongate body <NUM> may be configured as a female portion having an annular recess <NUM>-<NUM>. In an embodiment not part of the present invention, mounting portion <NUM> of the support catheter <NUM> may be configured as a corresponding male portion having an annular protrusion. In operation, first connector portion <NUM> of elongate body <NUM> is moved longitudinally relative to mounting portion <NUM> of the support catheter <NUM> such that the annular recess <NUM>-<NUM> of first connector portion <NUM> of elongate body <NUM> is engaged by the annular protrusion of mounting portion <NUM> of the support catheter <NUM> so as to establish the snap fit (and rotatable) connection of support catheter <NUM> to adjustable interface device <NUM>.

Referring to <FIG>, the embodiment of body <NUM> shown in <FIG> is converted to a screw-type connector as depicted in <FIG> and <FIG> by the inclusion of an adapter <NUM>, in accordance with the present invention. Adapter <NUM> includes a body <NUM>-<NUM> having a threaded end portion <NUM>-<NUM> and a snap-fit end portion <NUM>-<NUM>. Snap-fit end portion <NUM>-<NUM> includes an annular protrusion <NUM>-<NUM>. Annular protrusion <NUM>-<NUM> is configured for engagement with annular recess <NUM>-<NUM> of first connector portion <NUM> of elongate body <NUM>. The use of adapter <NUM> facilitates connection of the embodiment of body <NUM> depicted in <FIG> to a threaded connector, while facilitating full rotation of adapter <NUM>, and therefore, also facilitating full rotation of support catheter <NUM>.

Referring again to <FIG>, elongate member <NUM> includes a head end portion <NUM>-<NUM> and a shaft portion <NUM>-<NUM>. Shaft portion <NUM>-<NUM> longitudinally extends from head end portion <NUM>-<NUM>. Shaft portion <NUM>-<NUM> is located in interior channel <NUM>-<NUM> of the elongate body <NUM>. Shaft portion <NUM>-<NUM> is configured to slidably move axially along the longitudinal axis <NUM> to adjust a length of the adjustable interface device <NUM>. Head end portion <NUM>-<NUM> defines a second connector portion <NUM> that is configured to attach to a respective one of mounting portion <NUM> of handpiece <NUM>-<NUM> of ultrasonic catheter <NUM> and mounting portion <NUM> of support catheter <NUM>, depending on an orientation of adjustable interface device <NUM> relative to handpiece <NUM> and support catheter <NUM>.

Referring to <FIG> and <FIG>, in the present embodiment, second connector portion <NUM> of elongate member <NUM> is configured to attach to mounting portion <NUM> of handpiece <NUM>-<NUM> of ultrasonic catheter <NUM>. Also, in the present embodiment, second connector portion <NUM> of elongate member <NUM> and mounting portion <NUM> of handpiece <NUM>-<NUM> of ultrasonic catheter <NUM> are configured to form an interference fit, e.g., via a snap-type coupling. For example, second connector portion <NUM> of elongate member <NUM> may be configured as a female portion having an annular recess, and mounting portion <NUM> of handpiece <NUM>-<NUM> of ultrasonic catheter <NUM> may be configured as a male portion having an annular protrusion, wherein second connector portion <NUM> of elongate member <NUM> is moved longitudinally relative to mounting portion <NUM> of handpiece <NUM>-<NUM> of ultrasonic catheter <NUM> such that the annular recess of second connector portion <NUM> of elongate member <NUM> is engaged by the annular protrusion of mounting portion <NUM> of handpiece <NUM>-<NUM> of ultrasonic catheter <NUM> so as to establish the snap fit connection of handpiece housing <NUM> to adjustable interface device <NUM>.

Referring to <FIG>, elongate member <NUM> includes an elongate passage <NUM>-<NUM> that is in communication with the interior channel <NUM>-<NUM> of the elongate body <NUM>. Elongate passage <NUM>-<NUM> of elongate member <NUM> and interior channel <NUM>-<NUM> of the elongate body <NUM> are configured to receive ultrasonic catheter <NUM> that is supported by the support catheter <NUM>, wherein ultrasonic catheter <NUM> longitudinally extends from handpiece <NUM> through each of elongate passage <NUM>-<NUM> of elongate member <NUM>, interior channel <NUM>-<NUM> of elongate body <NUM>, and catheter lumen <NUM> of support catheter <NUM>.

Optionally, as depicted in <FIG>, shaft portion <NUM>-<NUM> of elongate member <NUM> may include a plurality of length indicators <NUM> longitudinally spaced along the shaft portion <NUM>-<NUM>. The plurality of length indicators <NUM> are configured to indicate a distance associated with the length of adjustable interface device <NUM>. The plurality of length indicators <NUM> may be, for example, in the form of etched or painted bands, and may further include numerical length indicators, if desired.

Referring to <FIG> and <FIG>, adjustable interface device <NUM> further includes a locking mechanism <NUM> configured to lock a longitudinal position of elongate member <NUM> relative to elongate body <NUM>, after the length of the adjustable interface device <NUM> is set by a user to a desired length. In the present embodiment, locking mechanism <NUM> includes interior channel <NUM>-<NUM> of elongate body <NUM> and shaft portion <NUM>-<NUM> of the elongate member <NUM>, as further describe below.

Interior channel <NUM>-<NUM> of the elongate body <NUM> includes a longitudinal track <NUM> and a plurality of arcuate tracks <NUM> that are formed in side wall <NUM>-<NUM> of elongate body <NUM>. Longitudinal track <NUM> and the plurality of arcuate tracks <NUM> form the elongate body <NUM> portion of locking mechanism <NUM>. The plurality of arcuate tracks <NUM> are longitudinally spaced along longitudinal track <NUM> and circumferentially intersect the longitudinal track <NUM>, wherein each arcuate track of the plurality of arcuate tracks <NUM> is a branch extension of the longitudinal track <NUM>. The plurality of arcuate tracks <NUM> of the interior channel <NUM>-<NUM> of elongate body <NUM> define a plurality of discrete increments (e.g., <NUM> increments) of adjustment of the length of adjustable interface device <NUM>.

In the present embodiment, longitudinal track <NUM> of interior channel <NUM>-<NUM> of elongate body <NUM> includes a pair of diametrically opposed longitudinal track sections <NUM>-<NUM>, <NUM>-<NUM>, and each of the pair of diametrically opposed longitudinal track sections <NUM>-<NUM>, <NUM>-<NUM> includes a respective plurality of complimentary arcuate track extensions formed by a respective portion of the plurality of arcuate tracks <NUM>. Notwithstanding, it is contemplated that longitudinal track <NUM> may be formed by a single longitudinal track section, or multiple longitudinal track sections.

Shaft portion <NUM>-<NUM> of the elongate member <NUM> has an outer surface <NUM>-<NUM> and a tail end portion <NUM>-<NUM>. Tail end portion <NUM>-<NUM> includes an engagement member <NUM> that extends radially outwardly from the outer surface <NUM>-<NUM>. In the present embodiment, engagement member <NUM> includes a pair of diametrically opposed tabs <NUM>-<NUM>, <NUM>-<NUM> that respectively slidably engage longitudinal track sections <NUM>-<NUM>, <NUM>-<NUM>. While in the present embodiment, engagement member <NUM> includes a pair of diametrically opposed tabs <NUM>-<NUM>, <NUM>-<NUM>, it is contemplated that engagement member <NUM> may be formed by a single tab, if desired.

With shaft portion <NUM>-<NUM> of the elongate member <NUM> positioned in interior channel <NUM>-<NUM> of elongate body <NUM>, engagement member <NUM> engages and slides along longitudinal track <NUM> to facilitate longitudinal movement of elongate member <NUM> relative to elongate body <NUM> of adjustable interface device <NUM>, so as to adjust a length of adjustable interface device <NUM>. However, in order to lock adjustable interface device <NUM> to a desired length, engagement member <NUM> is configured to be rotatably received into a selected one of the plurality of arcuate tracks <NUM> of elongate body <NUM> so as to lock the longitudinal position of the elongate member <NUM> relative to the elongate body <NUM>. For example, when elongate member <NUM> and elongate body <NUM> of adjustable interface device <NUM> are longitudinally positioned such that engagement member <NUM> is radially aligned with one of the plurality of arcuate tracks <NUM>, then a rotation of elongate member <NUM> relative to elongate body <NUM> causes engagement member <NUM> to depart from longitudinal track <NUM> and enter the respective arcuate track of the plurality of arcuate tracks <NUM> of elongate body <NUM>, thereby impeding longitudinal movement of elongate member <NUM> and elongate body <NUM>.

Also, in locking mechanism <NUM>, each arcuate track of the plurality of arcuate tracks <NUM> may include a pair of tapered walls <NUM>-<NUM>, <NUM>-<NUM>. The pair of tapered walls <NUM>-<NUM>, <NUM>-<NUM> is configured such that when engagement member <NUM> is rotatably received into a selected one of the plurality of arcuate tracks <NUM>, engagement member <NUM> of elongate member <NUM> is wedged between the pair of tapered walls <NUM>-<NUM>, <NUM>-<NUM> so as to maintain both the rotational and longitudinal position of elongate member <NUM> relative to the elongate body <NUM>, and further to impede both rotational and longitudinal movement of the elongate member <NUM> relative to the elongate body <NUM>, as well as to allow for selection of length.

<FIG> depict an alternative embodiment for a locking mechanism, in the form of a locking mechanism <NUM>. It is contemplated that locking mechanism <NUM> may serve as a supplemental locking mechanism to that of locking mechanism <NUM>, or may serve as a replacement for locking mechanism <NUM>, if desired.

Locking mechanism <NUM> includes a pivot member <NUM>, locking lever <NUM>, and a stow clip <NUM>.

Pivot member <NUM> is connected to the elongate body <NUM>. Pivot member <NUM> defines a pivot axis <NUM>.

Locking lever <NUM> has a pivot end <NUM>-<NUM> and a locking end <NUM>-<NUM>. In the present embodiment, locking end <NUM>-<NUM> of locking lever <NUM> has a U-shaped yoke <NUM>-<NUM> configured to clip over shaft portion <NUM>-<NUM> of the elongate member <NUM> in a snug fit, at a location adjacent, e.g., proximal, to head end portion <NUM>-<NUM> of elongate member <NUM>.

Pivot end <NUM>-<NUM> of locking lever <NUM> is rotatably connected to pivot member <NUM> of elongate body <NUM> by a pivot joint <NUM> located at pivot axis <NUM>. Pivot joint <NUM> may be, for example, a pin-hole arrangement. Locking lever <NUM> is configured to pivot at pivot joint <NUM> of pivot member <NUM> between a stowed position <NUM> as shown in <FIG> and a locking position <NUM> shown in <FIG>.

In stowed position <NUM>, shown in <FIG>, locking lever <NUM> is disengaged from shaft portion <NUM>-<NUM> of elongate member <NUM>, such that elongate member <NUM> may move longitudinally relative to elongate body <NUM>. Locking lever <NUM> is stowed by rotating locking lever <NUM> about pivot axis <NUM> until locking lever <NUM> engages stow clip <NUM>.

In the locking position <NUM>, shown in <FIG>, U-shaped yoke <NUM>-<NUM> of locking end <NUM>-<NUM> of locking lever <NUM> is engaged with, i.e., clips to, shaft portion <NUM>-<NUM> of the elongate member <NUM> adjacent to head end portion <NUM>-<NUM> of elongate member <NUM>, thereby preventing a shortening of adjustable interface device <NUM>. In operation, elongate member <NUM> is lengthened relative to elongate body <NUM>, and locking lever <NUM> is rotated about pivot axis <NUM> until U-shaped yoke <NUM>-<NUM> of locking end <NUM>-<NUM> of locking lever <NUM> engages, i.e., clips, to shaft portion <NUM>-<NUM> of the elongate member <NUM> adjacent to head end portion <NUM>-<NUM> of elongate member <NUM>.

While adjustable interface device <NUM> has been described above with respect to a medical system having an ultrasonic device with a particular configuration as an example of use, those skilled in the art will recognize that the adjustable interface device <NUM> may be adapted for use in other types of medical devices, including other types of ultrasonic devices, wherein a spacing between two medical components is to be controllably adjusted.

For definitional purposes, unless specified, the terms "connected" or "attached" are intended to embrace any operationally functional connection, whether direct or indirect.

Claim 1:
An adjustable interface device (<NUM>) for connecting two components of a medical device for an occlusion crossing or atherectomy procedure, comprising:
an elongate body (<NUM>) having a first end (<NUM>-<NUM>), a second end (<NUM>-<NUM>), an interior channel (<NUM>-<NUM>), and a side wall (<NUM>-<NUM>) that surrounds the interior channel, the interior channel configured to extend between the first end and the second end, the elongate body having a longitudinal axis (<NUM>) that longitudinally extends through the interior channel, the side wall configured to define a first connector portion (<NUM>) adjacent the second end, the first connector portion having an annular recess (<NUM>-<NUM>), the first connector portion configured to attach to a respective one of the two components of the medical device;
an elongate member (<NUM>) having a head end portion (<NUM>-<NUM>) and a shaft portion (<NUM>-<NUM>) that longitudinally extends from the head end portion, the shaft portion being located at least partially in the interior channel of the elongate body, the shaft portion configured to slidably move axially along the longitudinal axis to adjust a length of the adjustable interface device, the head end portion defining a second connector portion configured to attach to the other of the two components of the medical device; and
an adapter (<NUM>) having a threaded end portion (<NUM>-<NUM>) and a snap-fit end portion (<NUM>-<NUM>), the snap-fit end portion having an annular protrusion (<NUM>-<NUM>) configured for engagement with the annular recess of the first connector portion of the elongate body.