Patent Description:
This application relates generally to a medical tube assembly and, more specifically, to a device for clearing obstructions from a medical tube of the medical tube assembly.

Medical tubes can be used to deliver fluids or devices into a patient's body and/or to drain bodily fluids and secretions from compartments and structures within the body. For example, medical tubes can be used to drain fluid from one's bladder, from the colon or other portions of the alimentary tract, or from the lungs or other organs in conjunction with various therapies. As another example, medical tubes can be used to drain blood and other fluids that typically accumulate within the body cavity following traumatic surgery. As yet another example, medical tubes can be used to deliver fluids to a patient's body for nourishment or they can be used to provide access to the vasculature for removal or delivery of fluids or devices. Typically, a medical tube is inserted into the patient so that its distal end is provided in or adjacent the space where it is desired to remove or deliver material while a proximal portion remains outside the patient's body, where it can be connected, for example, to a suction source.

Fluids passing through a medical tube (particularly those including blood or blood platelets) can form clots or other obstructions within the medical tube, which can partially or totally obstruct the suction pathway within the tube. Obstruction of the medical tube can impact its effectiveness to remove or deliver the fluid and other material for which it was originally placed, eventually rendering the medical tube partially or totally non-functional. In some cases, a non-functional tube can have serious or potentially life-threatening consequences. For example, if there is a blockage in a chest tube following cardiac or pulmonary surgery, the resulting accumulation of fluid around the heart and lungs without adequate drainage can cause serious adverse events such as pericardial tamponade and pneumothorax.

Patent document n°<CIT> discloses a solution by providing a spool drive system for actuating a guide wire, the system comprises a spool housing having an inlet adapted to establish fluid communication between a medical tube and the spool housing. The system further comprises a spool resident within the spool housing, the spool being rotatable about an axis thereof to wind and unwind the guide wire on the spool, thereby withdrawing or advancing, respectively, the guide wire through the inlet. The system also includes a track spaced from and extending at least partially about a perimeter of the spool following a curvature thereof within the spool housing, the track is adapted to direct said guide wire onto or off of said spool about the perimeter thereof as the spool is rotated.

The invention is defined by the features of independent claim <NUM>. The following presents a simplified summary of the disclosure in order to provide a basic understanding of some example aspects described in the detailed description.

In accordance with a first aspect, a device for clearing obstructions from a medical tube includes a housing defining an interior, an exterior, and a port providing communication therebetween. The device further includes an elongated guide wire residing at least partially within the housing, a spool within the housing for dispensing and accumulating the elongated guide wire, the spool being rotatable relative to the housing about a spool axis and first and second rollers defining a nip therebetween. The guide wire is adapted to extend through the nip and be drivable for advancement and retraction thereof through the port via rotation of the rollers.

Optionally, the device includes a first roller shaft coupled to the first roller and being rotatable therewith about a first roller axis, a second roller shaft coupled to the second roller and being rotatable therewith about a second roller axis, and a transmission operatively connected to each of the first and second roller shafts and configured to synchronize rotation thereof about their associated roller axes in opposing directions. Optionally, the transmission includes a first gear fixed to the first roller shaft and a second gear fixed to the second roller shaft.

Optionally, the device includes a wall that defines a roller shaft opening, the first roller shaft extending through the roller shaft opening. The device optionally further includes a seal member provided about the first roller shaft that inhibits fluid communication through the roller shaft opening.

Optionally, the second roller is rotatably supported by a movable carriage configured to move between a disengaged position where the second roller does not interact with the first roller and an engaged position where the second roller interacts with the first roller to thereby define the nip therebetween.

Optionally, the carriage is pivotable about a carriage axis that is spaced from and substantially parallel to the second roller axis in order to move the carriage between the disengaged and engaged positions.

Optionally, the device includes an actuator that is accessible from the exterior to move the actuator from a first position to a second position, the actuator being configured to move the carriage from the disengaged position to the engaged position as the actuator is moved from the first position to the second position.

Optionally, the actuator includes a cam body with a cam surface that engages the carriage as the actuator is moved from the first position to the second position to move the carriage from the disengaged position to the engaged position.

Optionally, the device includes a guide passage having an inner surface, the actuator being slidably received through the guide passage. Moreover, the device optionally includes a seal member configured to establish a seal between the actuator and the inner surface of the guide passage.

Optionally, when the actuator is in the first position, the interior and exterior of the housing are in fluid communication through the guide passage. Moreover, when the actuator is in the second portion, the seal inhibits fluid communication through the guide passage.

Optionally, the device further includes a power circuit for supplying electrical energy to a motor for rotating at least one of the first and second rollers. The carriage is configured to open the power circuit when the carriage is in the disengaged position and to close the circuit when the carriage is in the engaged position.

Optionally, the elongated guide wire is coupled to the spool, and the spool is configured to freely rotate relative to the housing such that the spool passively rotates in response to compressive and tensile forces in the elongated guide wire as the elongated guide wire is driven through the nip.

Optionally, the device further includes a guide wall that extends at least partially about the circumference of the spool, the guide wall having an axis of curvature that is coaxial with the spool axis.

Optionally, the guide wall includes a rim and a plurality of guide projections that extend radially inward from the rim toward the spool and are circumferentially spaced about the spool.

Optionally, the device further includes a magnet coupled to the spool, and an encoder configured to detect a rotary position of the magnet about the spool axis.

Optionally, an outer surface portion of the housing is concave in order to accommodate a curvature of a patient's body to which the device is to be mounted in use.

Optionally, the device further includes a flexible substrate adhered and conforming to the concave outer surface portion and having an exposed surface with an adhesive for adhering the device to a patient's body in use.

Optionally, the device further includes a motor within the housing operable to drive at least one of the first roller and the second roller in order to drive the guide wire through the nip; a power supply within the housing coupled to the motor via a power circuit to supply electrical energy thereto; a user interface on the housing accessible from the exterior; and a controller within the housing operatively coupled to the motor and to the user interface, and configured to receive user inputs from the user interface for directing the advancement or withdrawal of the guide wire, and to control operation of the motor for driving the guide wire based on the user inputs. Optionally, the device is a self-contained, portable unit.

Optionally, the first and second rollers are located within the housing.

Optionally, a medical tube assembly includes the device, the medical tube, and a connector for connecting the device to the medical tube. Moreover, the connector includes a body that defines a distal branch, a proximal branch, and a drain branch, all of which being in fluid communication with one another via a common hub chamber. The proximal branch is rotatably coupled to the port in order to accommodate the guide wire therethrough.

Optionally, the connector includes one or more guide bodies within the proximal branch, each guide body being tubular in shape, with an outer diameter that approximates an inner diameter of the proximal branch, and a through-hole that extends through the guide body.

Optionally, the body of the connector defines an access branch in fluid communication with the hub chamber, and the connector further includes a valve assembly that is operable to provide selective communication through the access branch.

Optionally, a device for clearing obstructions from a medical tube includes a housing defining an interior, an exterior, and a port providing fluid communication therebetween. The device further includes an elongated guide wire residing at least partially within the housing. An outer surface portion of the housing is concave in order to accommodate a curvature of a patient's body to which the device is to be mounted in use. The guide wire is adapted to be drivable for advancement and retraction through the port and into a medical tube.

Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. Relative language used herein is best understood with reference to the drawings, in which like numerals are used to identify like or similar items. Further, in the drawings, certain features may be shown in schematic form.

It is to be noted that the terms "proximal" and "distal" as used herein when describing two ends or portions of a feature indicate a relative positioning that those two ends or portions will generally have along an in-line system relative to a patient, the distal end or portion being closer to (or more advanced within) the patient than the proximal end or portion. For example, in an in-line system comprising a tube that draws fluid from the patient through the tube along a flow path, a distal end or portion of the tube will be closer to (likely implanted within) a patient than a proximal end or portion, which will be outside the patient) along the flow path of the fluid.

It is further to be noted that the term "coupled" as used herein when describing two or more features means that the features can be integral with each other or that the features can be separate features that are removably or non-removably attached to each other using various means such as threads, fasteners, hooks, clips, adhesive, welds, or other means of attaching two separate features. The features may be movably coupled to each other such that each feature is movable (e.g., slidable, rotatable, etc.) relative to the other, or the features may be fixedly coupled to each other such that neither feature can substantially move relative to the other.

Examples will now be described more fully hereinafter with reference to the accompanying drawings in which example embodiments are shown. Whenever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts. However, aspects may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

As shown in <FIG>, an example medical tube assembly <NUM> includes a medical tube <NUM> and a device <NUM> for clearing obstructions from the medical tube <NUM>. The medical tube <NUM> is a tube having a length, an inner diameter, and an outer diameter that can each vary between different embodiments. Indeed, the medical tube <NUM> can have a variety of different shapes and configurations. The medical tube <NUM> can be used to drain bodily fluids and secretions from within body compartments and structures such as, for example, fluid from within a person's bladder, colon, lungs, brain, thoracic cavity, or any other body structure. The medical tube <NUM> can alternatively be used to deliver fluids, solids, semi-solids, or devices to a body compartment or structure. In some examples, the medical tube <NUM> can be used to both drain bodily fluids and deliver fluids.

The medical tube <NUM> has a distal opening <NUM> and a proximal opening <NUM> and can be inserted into a patient so that its distal opening <NUM> is provided in or adjacent the space where it is desired to remove or deliver material, while the proximal opening <NUM> remains outside the patient's body. In the example shown in <FIG>, the proximal opening <NUM> and distal opening <NUM> respectively coincide with proximal and distal ends of the medical tube <NUM>.

The clearance device <NUM> includes a guide wire <NUM> that can be advanced or withdrawn through the medical tube <NUM> to help dislodge or draw obstructing material within the medical tube <NUM>. Moreover, one or more clearance members <NUM> can be coupled to a distal end <NUM> or other portions of the guide wire <NUM> to aid in dislodging or drawing of material as the guide wire <NUM> translates through the medical tube <NUM>. In the illustrated embodiment, the guide wire <NUM> is circular in cross-section and is made of a material with elastic or shape memory properties such as, for example, nickel-titanium. Moreover, a single clearance member <NUM> in the form of a bead is coupled to the distal end <NUM> of the guide wire <NUM>. However, the guide wire <NUM> may include or be made of other shapes or materials, and one or more clearance members <NUM> of other forms may be coupled to the guide wire <NUM> in other embodiments. Various examples of possible guide wires and clearance members are disclosed in <CIT> and <CIT> and <CIT>.

Turning to <FIG>, the clearance device <NUM> further includes a roller assembly <NUM> that, as discussed further below, is operable to advance or retract the guide wire <NUM> through the medical tube <NUM>. Moreover, the clearance device <NUM> includes a housing <NUM> configured to preserve a sterile field within the housing <NUM> for the roller assembly <NUM>, the guide wire <NUM> (or portion thereof) positioned within the clearance device <NUM>, as well as other internal components.

The housing <NUM> defines an interior <NUM> and an exterior <NUM>, and a port <NUM> for providing access to the interior <NUM> of the housing <NUM>. The guide wire <NUM> can reside at least partially within the housing <NUM>, and can be translated through the port <NUM> of the housing <NUM> to advance or retract the guide wire <NUM> within the medical tube <NUM>. In the illustrated embodiment, the housing <NUM> includes a first shell half <NUM> and a second shell half <NUM> that can be (optionally removably) connected to each other to seal the interior <NUM> from the exterior <NUM>, forming an enclosure. In particular, the shell halves <NUM>, <NUM> are connected together with fasteners (e.g., screws), and a seal member (e.g., gasket, adhesive) is provided between the shell halves <NUM>, <NUM> along their seam to inhibit fluid communication through the seam. However, the housing <NUM> may consist of a single shell or more than two shell components in other examples. It is to be appreciated that the shell components can be permanently or non-permanently secured together in any desired manner. For instance, two or more shell components can be connected via welding, such as ultrasonic welding, induction welding, laser welding, etc. or sealed by extruded-bead sealing or via suitable adhesives.

With reference now to <FIG>, the roller assembly <NUM> will be described in further detail. <FIG> shows a close-up of the roller assembly <NUM> within the housing <NUM>, <FIG> shows the roller assembly <NUM> separated from the housing <NUM>, and <FIG> shows an exploded view of the roller assembly <NUM>.

The roller assembly <NUM> includes a first roller shaft <NUM> and a second roller shaft <NUM> (best seen in <FIG>) that respectively define a first roller axis D<NUM> and a second roller axis D<NUM>. The roller shafts <NUM>, <NUM> are rotatable about their respective axes D<NUM>, D<NUM>. Moreover, the roller shafts <NUM>, <NUM> are arranged such that respective axes D<NUM>, D<NUM> are spaced apart and substantially parallel to each other.

The roller assembly <NUM> further includes first and second rollers <NUM>, <NUM> respectively fixed to the first and second roller shafts <NUM>, <NUM> such that the rollers <NUM>, <NUM> are rotatable with the roller shafts <NUM>, <NUM> about their respective axes D<NUM>, D<NUM>. In particular, the first roller <NUM> is fixed to and coaxial with the first roller shaft <NUM>, and the second roller <NUM> is fixed to and coaxial with the second roller shaft <NUM>.

The first and second rollers <NUM>, <NUM> can be axially aligned such that the outer circumferential surfaces of the rollers <NUM>, <NUM> face each other and define a nip <NUM> therebetween (see <FIG>). Moreover, the guide wire <NUM> can be arranged such that the guide wire <NUM> extends through the nip <NUM> and is engaged by (e.g. squeezed between) the rollers <NUM>, <NUM>. In this manner, the rollers <NUM>, <NUM> can be rotated about their respective axes D<NUM>, D<NUM> in opposite directions to drive the guide wire <NUM> through the nip <NUM> in either direction depending on the directions of rotation of the rollers <NUM>, <NUM>, to thereby advance or retract the guide wire <NUM> within the medical tube <NUM>. Preferably, at least one of the rollers <NUM>, <NUM> is coated with, or its respective circumferential surfaces is provided as, urethane or some other high-friction material to increase friction between the rollers <NUM>, <NUM> at their nip, to aid in driving the guide wire <NUM> through the nip <NUM> to facilitate translation of the guide wire <NUM> through the medical tube <NUM>. In addition or alternatively, the rollers <NUM>, <NUM> themselves may comprise urethane or some other high-friction material. For instance, at least one of the rollers <NUM>, <NUM> can be overmolded with urethane or other high friction material(s). A variety of different materials and/or coatings may be used for the rollers <NUM>, <NUM> without departing from the scope of this disclosure. At least one of the rollers <NUM>, <NUM> can comprise a rigid material, such as plastic or metal that is not necessarily a high friction material, while the opposing roller is (or has a coating of) high-friction or compressive material that can be pressed against the rigid-material roller to define a high-friction nip <NUM>. Additionally, as shown in <FIG>, at least one of the rollers <NUM>, <NUM> can include features to improve gripping, such as treads, radial lugs, ribs, grooves, etc. <FIG> illustrates a roller having a circumferential groove <NUM> therein. One or both rollers <NUM>, <NUM> can include one or more than one such circumferential groove to maintain the guide wire <NUM> within the nip <NUM> and to mitigate any walking or drifting of the guide wire <NUM> laterally within the nip <NUM>. The circumferential groove(s) can also facilitate gripping of the guide wire <NUM> within the nip <NUM>. <FIG> illustrates a roller having a tread pattern <NUM> around a circumference thereof. As noted above, the tread pattern <NUM> facilitates gripping of the wire <NUM> between the rollers <NUM>, <NUM>. Any other suitable tread configuration or other pattern can be provided around at least a portion of the circumference of at least one of the rollers <NUM>, <NUM> to improve gripping of the wire <NUM> within the nip <NUM>.

The roller shafts <NUM>, <NUM> and rollers <NUM>, <NUM> can be rotatably coupled to the housing <NUM> in a variety of ways. For instance, with respect to the first roller shaft <NUM> and first roller <NUM>, the roller assembly <NUM> can include a wall <NUM>, bracket, or the like, fixed within the housing <NUM>, wherein the wall <NUM> defines a roller shaft opening <NUM> for the first roller shaft <NUM> (see <FIG>). The first roller shaft <NUM> can extend through the opening <NUM> such that it is rotatable within the opening <NUM>. Moreover, one or more features can be provided to inhibit axial movement of the first roller shaft <NUM> through the opening <NUM>. For example, one or more collars <NUM> can be fixed on the first roller shaft <NUM> (e.g., via set screws, being integral to the first roller shaft <NUM>), and can be sized to interfere with axial movement of the first roller shaft <NUM> through the opening <NUM>. In addition or alternatively, one or more snap rings can be snapped into corresponding annular grooves along the first roller shaft <NUM>, and can also be sized to interfere with axial movement of the first roller shaft <NUM> through the opening <NUM>. Alternatively, or additionally, one or more collars <NUM> can be press fit onto the first roller shaft <NUM>, with or without adhesive and/or the first roller shaft <NUM> can be staked to maintain the collar(s) within a predetermined portion of the first roller shaft <NUM>. Alternatively, or additionally, the first roller shaft <NUM> can be press fit onto the roller <NUM>, with or without adhesive. The first roller shaft <NUM> can include at least one key feature, such as flat <NUM> shown in <FIG>, in order to mitigate slippage of the collar(s), roller <NUM>, and any other components coupled to the first roller shaft <NUM>.

With respect to the second roller shaft <NUM> and second roller <NUM>, the roller assembly <NUM> can include a carriage <NUM> that rotatably supports the second roller shaft <NUM>, such that it is rotatable relative to the carriage <NUM> about the second roller axis D<NUM>. The carriage <NUM> can be movably coupled to the wall <NUM> of the roller assembly <NUM> such that the carriage <NUM> is movable relative thereto. For example, the carriage <NUM> in the illustrated embodiment is pivotally coupled to the wall <NUM> such that the carriage <NUM> is pivotable about a carriage axis X<NUM> that is spaced from and substantially parallel to the second roller axis D<NUM>. Alternatively or additionally, the carriage <NUM> can be linearly translating, e.g., vertically or horizontally moveable within the housing <NUM>.

The movable carriage <NUM> enables the second roller shaft <NUM> and second roller <NUM> coupled thereto to be moved relative to the first roller shaft <NUM> and first roller <NUM> to vary the spacing between the first and second rollers <NUM>, <NUM>. In particular, the carriage <NUM> can be moved (e.g., pivoted about the carriage axis X<NUM>) in order to move the second roller <NUM> into a disengaged position wherein the rollers <NUM>, <NUM> are spaced apart to establish a clearance between the guide wire <NUM> and one or both rollers <NUM>, <NUM>. Conversely, the carriage <NUM> also can be moved (e.g. pivoted about axis X<NUM>) into an engaged position wherein the rollers <NUM>, <NUM> are closer to each other and appropriately distanced (and possibly contacting one another) to engage the guide wire <NUM> at the nip <NUM> defined therebetween. Thus, the second roller <NUM> can interact with the first roller <NUM> in the engaged position to drive the guide wire <NUM> through the nip <NUM> therebetween. Whereas, in a disengaged position as described above, no such interaction occurs. It is to be appreciated that the engaged position can include a position where the rollers <NUM>, <NUM> are in contact with one another, such as via a slip fit or interference fit, in which the rollers <NUM>, <NUM> are compressed against and around the guide wire <NUM>. Meanwhile, the second roller <NUM> can be spaced from the first roller <NUM> in the disengaged position to disable interaction of first and second rollers <NUM>, <NUM>. <FIG> illustrates the carriage <NUM> and second roller <NUM> in a disengaged position, with the wire <NUM> passing between, but not being forcibly engaged by, the opposing circumferential surfaces of the rollers <NUM>, <NUM>.

The roller assembly <NUM> can be initially configured with the carriage <NUM> in its disengaged position. This initial configuration is particularly advantageous if the clearance device <NUM> will be stored for an extended period of time before use, so that the rollers <NUM>, <NUM> are not persistently engaged with the guide wire <NUM> during storage, which could negatively affect the guide wire <NUM> and/or rollers <NUM>, <NUM>. Moreover, the carriage <NUM> may be spring loaded in the open position (disengaged) so that forces experienced during shipping, etc., do not unintentionally engage the carriage (rollers, power, etc.). The spring <NUM> can be made of various materials such as foam or steel wire coil. As illustrated in <FIG>, the spring <NUM> is a foam cylinder positioned at the distal end of the carriage <NUM>. When it is desirable to use the clearance device <NUM> for translating the guide wire <NUM>, the carriage <NUM> can be moved from its disengaged position to its engaged position to enable driving of the guide wire <NUM> via the first and second rollers <NUM>, <NUM>. The clearance device <NUM> can include an actuator <NUM> that is operable to move the carriage <NUM> (and the second roller <NUM> coupled thereto) from its disengaged position to its engaged position. As discussed in further detail below, the actuator <NUM> can be movably coupled to the housing <NUM> such that the actuator <NUM> is accessible from the exterior <NUM> of the housing <NUM> and movable from a first position to a second position by a user from the exterior <NUM> thereof. Moreover, the actuator <NUM> can be configured to engage the carriage <NUM> as the actuator <NUM> is moved from its first position to its second position to move the carriage <NUM> from its disengaged position to its engaged position.

For instance, as shown in <FIG>, the actuator <NUM> can include an actuator shaft <NUM> that defines an actuator axis X<NUM>. Moreover, the actuator <NUM> can include a cam body <NUM> and a plug <NUM> that are provided on opposite ends of the actuator shaft <NUM>. The plug <NUM> may be radially larger than the actuator shaft <NUM>. Moreover, the cam body <NUM> has a cam surface <NUM> that is ramped relative to the actuator axis X<NUM> (i.e., the cam surface <NUM> extends in a direction oblique to the actuator axis X<NUM>). The cam surface <NUM> can be curved (as shown in the illustrated embodiment), or the cam surface <NUM> can be planar.

As further shown in <FIG>, the clearance device <NUM> can include a guide passage <NUM> (e.g., formed in the housing <NUM>) extending into the interior <NUM> of the housing <NUM> and configured to slidably receive the actuator <NUM>. The actuator guide passage <NUM> has an inner surface <NUM> that defines a guide channel <NUM> extending through the guide passage <NUM> from the exterior <NUM> of the housing <NUM> to its interior <NUM>. The actuator <NUM> can be slidably received within the guide passage <NUM> such that the actuator <NUM> is slidable through the guide channel <NUM> along the actuator axis X<NUM>. In particular, the housing <NUM> can include one or more guide arms <NUM> that extend inward from the inner surface <NUM> of the guide passage <NUM> and slidingly engage the shaft <NUM> of the actuator <NUM> to hold and center the actuator <NUM> within the guide passage <NUM>.

The actuator <NUM> can be arranged within the guide passage <NUM> such that its cam body <NUM> is aligned inward of its plug <NUM>, with the cam body <NUM> being located on the inner side of the guide arms <NUM> and the plug <NUM> being located on the outer side of the guide arms <NUM>. In this manner, the cam body <NUM> and plug <NUM> can limit axial movement of actuator <NUM> through the guide passage <NUM> in both directions.

The actuator <NUM> can be slid within the guide passage <NUM> along its actuator axis X<NUM> from a first position to a second position, the second position being further into the housing <NUM> along the actuator axis X<NUM> than the first position. More specifically, in the first position, the actuator <NUM> will be located along the actuator axis X<NUM> such that its plug <NUM> protrudes outwardly from, and optionally resides completely outside of, the guide channel <NUM> in the exterior <NUM> of the housing <NUM> (see e.g., <FIG>). Meanwhile, in the second position, the actuator <NUM> will be advanced along the actuator axis X<NUM> such that the plug <NUM> has been advanced inward through the guide channel <NUM>, and optionally that its outer surface is flush with the surrounding portion of the housing.

When the actuator <NUM> is in its first (withdrawn) position, the carriage <NUM> will assume its disengaged position. As the actuator <NUM> is moved (e.g., pushed or advanced) from its first position along the actuator axis X<NUM> into the housing <NUM>, the cam surface <NUM> of the actuator <NUM> is designed to engage an associated mating surface <NUM> of the carriage <NUM> (see <FIG>) and urge the carriage <NUM> from its disengaged position toward its engaged position, e.g. by pivoting the carriage <NUM> about the carriage axis X<NUM> or by translating the carriage <NUM> into position. For example, a cam may be used to translate the carriage vertically to engage the rollers.

The actuator <NUM> is advanced until the actuator <NUM> reaches its second position, at which point the carriage <NUM> will assume its engaged position. The carriage <NUM> may also be moved between its unengaged and engaged positions by action of a spring. For example, when a user engages the actuator <NUM>, via a button or the like, the carriage <NUM>, which can be spring loaded, is released. It is to be appreciated that if the carriage is spring loaded, this configuration can also be employed to maintain a predetermined compression force on the rollers <NUM>, <NUM>.

The clearance device <NUM> can include one or more features for locking the actuator <NUM> in its second position. For example, as shown in <FIG>, the clearance device <NUM> can include a catch <NUM> (e.g., formed by the housing <NUM>) that will mate with an associated recess <NUM> in the actuator <NUM> as the actuator <NUM> enters its second position, thereby locking the actuator <NUM> and inhibiting movement of the actuator <NUM> back toward its first position. In other examples, the catch <NUM> may be provided on the actuator <NUM> and a recess may be formed by the housing <NUM> that captures the catch <NUM> when the actuator <NUM> enters its second position. The actuator <NUM> may be locked in its second position in a variety of different ways without departing from the scope of the invention.

A seal member <NUM> is configured to establish a seal between the actuator <NUM> and the guide passage <NUM> based on the position of the actuator <NUM>. For instance, the seal member <NUM> can be an O-ring provided on the actuator <NUM> and extending circumferentially about the plug <NUM> of the actuator <NUM>. The seal member <NUM> can be configured such that when the actuator <NUM> is in its second position with the plug <NUM> residing at least partially within the guide channel <NUM>, the seal member <NUM> will establish a seal between the plug <NUM> and the inner surface <NUM> of the guide passage <NUM>, which inhibits fluid communication through the guide channel <NUM>. Meanwhile, when the actuator <NUM> is in its first position with the plug <NUM> (and seal member <NUM> coupled thereto) residing out of the guide channel <NUM>, in the illustrated embodiment fluid communication between the interior <NUM> and exterior <NUM> of the housing <NUM> will be permitted through the guide channel <NUM> between the actuator <NUM> and the inner surface <NUM> of the guide passage <NUM>.

The selective seal described above enables a sterile field to be maintained in the housing <NUM> when the actuator <NUM> is in the second position and the rollers <NUM>, <NUM> are engaged with the guide wire <NUM> and operable to advance or retract the guide wire <NUM>. The selective seal also enables a pressure (i.e. vacuum) to be maintained in the housing <NUM> when the actuator <NUM> is in the second position. Conversely, when the actuator <NUM> is in its first position and the rollers <NUM>, <NUM> are inoperable to advance or retract the guide wire <NUM>, fluid communication between the interior <NUM> and exterior <NUM> of the housing <NUM> will be permitted through the guide channel <NUM>. Such fluid communication can permit a sterilizing fluid (e.g., gas such as ethylene oxide) to be introduced and/or evacuated into and/or from the interior <NUM> of the housing <NUM> through the guide channel <NUM> for the purposes of sterilizing the interior <NUM>. Alternatively, a seal can be provided such that the sterile field is maintained within the housing <NUM> when the actuator <NUM> is in either the first or second position. Fluid communication between the interior <NUM> and exterior <NUM> of the housing <NUM> can be accomplished via one or more separate vent features, as desired.

The actuator <NUM> in the illustrated embodiment is designed such that the actuator <NUM> will be locked in its second position (i.e., via catch <NUM>) once moved thereto, and will not be returnable to its first position. However, in other examples, the actuator <NUM> can be releasable from its locked state and returnable to its first position, to return the carriage <NUM> to its disengaged position and (in select embodiments) enable fluid communication through the guide channel <NUM> for a sterilizing fluid to be introduced and/or evacuated into and/or from the housing <NUM>.

Referring back to <FIG>, one or both the first and second rollers <NUM>, <NUM> can be driven by a motor. For instance, in the illustrated embodiment the roller assembly <NUM> includes a single motor <NUM> that is coupled to the first roller shaft <NUM> on an opposite side of the partition wall <NUM> from the first roller <NUM>. The motor <NUM> is operable to rotate the first roller shaft <NUM> and first roller <NUM> at a fixed or variable speed, to facilitate driving the guide wire <NUM> in both forward and reverse directions. The motor <NUM> preferably is a DC brushed gear motor, although other motors or drive mechanisms, such as a belt driven shaft, are possible in other examples. Moreover, it is to be appreciated that a similar motor may be similarly coupled to the second roller shaft <NUM> to rotate the second roller <NUM>, in addition or as an alternative to the motor <NUM> coupled to the first roller shaft <NUM>.

In some embodiments, one of the rollers <NUM>, <NUM> can be rotated by a motor or other drive mechanism, while the other of the rollers <NUM>, <NUM> is configured to passively rotate in response to rotation of the driven roller due to the frictional engagement between the rollers <NUM>, <NUM> and the intermediate guide wire <NUM> extending through the nip therebetween (if present). For example, the first roller <NUM> can be driven by the motor <NUM> described above while both rollers <NUM>, <NUM> are engaged with the guide wire <NUM>. Such rotation of the first roller <NUM> will exert a tangential force on the guide wire <NUM> that causes the guide wire <NUM> to translate through the nip <NUM> between the rollers <NUM>, <NUM>. The second roller <NUM>, in turn, can passively rotate in response to translation of the guide wire <NUM> (or to rotation of the first roller <NUM>, or both) due to its frictional engagement therewith. Likewise, if the rollers <NUM>, <NUM> are in direct contact, rotation of the driven roller will directly rotate the passive roller. The passive roller may include a bearing or similar structure in order to reduce friction and thus, power consumption.

In other embodiments, the clearance device <NUM> can include a transmission that enables both rollers <NUM>, <NUM> to be driven by a single motor (or other drive mechanism) in a synchronized manner. For instance, as shown in <FIG> and <FIG> the roller assembly <NUM> includes a transmission <NUM> having a first gear <NUM> that is coaxial with and fixed to the first roller shaft <NUM> such that the first gear <NUM> is rotatable with the first roller shaft <NUM> about the first roller axis D<NUM>. The transmission <NUM> further includes a second gear <NUM> that is coaxial with and fixed to the second roller shaft <NUM> such that the second gear <NUM> is rotatable with the second roller shaft <NUM> about the second roller axis D<NUM>. The first and second gears <NUM>, <NUM> of the transmission <NUM> are meshed with each other such that rotation of the first roller shaft <NUM> (e.g., via the motor <NUM>) in one direction (e.g., clockwise) is transmitted into rotation of the second roller shaft <NUM> in an opposite direction (e.g., counter-clockwise). However, the transmission <NUM> may include intermediate gears between the first and second gears <NUM>, <NUM> in other examples such that the first and second gears <NUM>, <NUM> are not directly meshed with each other but nonetheless transmit rotation therebetween via the intermediate gears.

The transmission <NUM> is thus configured to synchronize rotation of the first and second roller shafts <NUM>, <NUM> (and the first and second rollers <NUM>, <NUM> coupled thereto) about their associated roller axes D<NUM>, D<NUM> in opposing directions. Preferably, in embodiments wherein the rollers <NUM>, <NUM> are substantially similar in diameter, the transmission <NUM> is configured to synchronize rotation of the rollers <NUM>, <NUM> with a <NUM>:<NUM> ratio of angular velocities. However, other ratios of angular velocities are possible in other embodiments, particularly embodiments wherein the rollers <NUM>, <NUM> have different diameters where it may be desirable to ensure constant lineal velocities between their respective circumferential surfaces at the nip therebetween, resulting in unequal rotational velocities.

The two-roller assembly described herein is only an example of a configuration that can be employed to grip and feed the guide wire <NUM> through the device <NUM>. For instance, the device may include two sets of rollers positioned adjacent or near each other. Alternatively, the guide wire can be fed through a three roller system with one driven roller and two passive rollers. It is to be appreciated that any suitable configuration can be employed and is contemplated as falling within the scope of the present disclosure.

Turning to <FIG>, the clearance device <NUM> includes a spool <NUM> within the housing <NUM> for dispensing and accumulating the guide wire <NUM> as the guide wire <NUM> is advanced or retracted through the port <NUM> (and hence the medical tube <NUM>) by the roller assembly <NUM>. The spool <NUM> is rotatably coupled to the housing <NUM> such that the spool <NUM> is rotatable relative to the housing <NUM> about a spool axis Y<NUM>. Optionally, as shown in <FIG>, the spool <NUM> can be rotatably coupled in a bearing <NUM> within the housing <NUM> such that the spool <NUM> is rotatable relative to the housing about the spool axis Y<NUM>. Moreover, the guide wire <NUM> can be fixed to the spool <NUM> at its proximal end and wrapped at least partially about the spool <NUM> circumference, with a free portion of the guide wire <NUM> feeding off of the spool <NUM> and through the nip <NUM> between the first and second rollers <NUM>, <NUM>. The spool <NUM> can be configured to freely rotate relative to the housing <NUM> such that the spool <NUM> passively rotates about its spool axis Y<NUM> in response to compressive and tensile forces in the guide wire <NUM> as it is driven through the nip <NUM>. More specifically, as the roller assembly <NUM> is operated to advance the guide wire <NUM> through the nip <NUM> and into the medical tube <NUM>, the spool <NUM> can passively rotate to dispense the guide wire <NUM> off of the spool <NUM> and to the nip <NUM>. Conversely, as the roller assembly <NUM> is operated to retract the guide wire <NUM> through the nip <NUM> from the medical tube <NUM>, the spool <NUM> can passively rotate to accumulate the guide wire <NUM> from the nip <NUM> and onto the spool <NUM>.

However, it is to be appreciated that the spool <NUM> may be actively driven in other embodiments to accumulate or dispense guide wire <NUM> length as the guide wire translates through the nip <NUM>. For instance, as shown in <FIG>, the transmission <NUM> described above may be further configured so that the motor <NUM> drives the spool <NUM> in a synchronized manner with the rollers <NUM>, <NUM> to dispense or accumulate the guide wire <NUM> as the guide wire translates through the nip <NUM>. In particular, the transmission <NUM> can include one or more additional gears <NUM> that are configured to transmit rotation of the first roller shaft <NUM> by the motor <NUM> into synchronized rotation of the spool <NUM>.

The clearance device <NUM> can include one or more guide features within its housing <NUM> for directing the guide wire <NUM> through the nip between the rollers <NUM>, <NUM> and about the spool <NUM>, as will now be described in further detail.

For example, as shown in <FIG> & <FIG>, the roller assembly <NUM> can include a distal wire guide <NUM> and a proximal wire guide <NUM> arranged on opposite sides (e.g., distal and proximal sides) of the roller nip <NUM> that are configured to keep the guide wire <NUM> centered through the nip <NUM> of the rollers <NUM>, <NUM>. Each wire guide <NUM>, <NUM> can include a support body <NUM> that is fixed within the housing <NUM>; for example to the partition wall <NUM> of the roller assembly <NUM> as shown. Moreover, each wire guide <NUM>, <NUM> can include a guide ring <NUM> that is fixed to and supported by its support body <NUM>. In particular, each support body <NUM> can be fixed to the partition wall <NUM> within the housing <NUM>, and each guide ring <NUM> can include a Teflon O-ring, as shown in the illustrated embodiment. The guide wire <NUM> can be fed through the guide rings <NUM> of the distal and proximal wire guides <NUM>, <NUM>, which will center the guide wire <NUM> through the nip <NUM> of the rollers <NUM>, <NUM>. In this preferred configuration, each guide ring <NUM> reduces contact with the guide wire <NUM>, which results in reduced friction and reduced resistance to winding as the guide wire <NUM> is advanced or withdrawn.

As another example, the clearance device <NUM> can include a guide wall <NUM> (see <FIG>) that extends at least partially about the circumference of the spool <NUM>, which can constrain the guide wire <NUM> about the spool <NUM> and ensure that the guide wire <NUM> resides in close proximity to spool <NUM> about its circumference. In particular, the guide wall <NUM> can be a circular wall defining a circular recess at its center whose diameter approximates that of the spool <NUM>, within which the spool <NUM> may be seated so that the outermost portion of the spool opposes the guide wall <NUM> about the spool circumference. The guide wall <NUM> preferably is a curved wall with an axis of curvature Y<NUM> that is coaxial to the spool axis Y<NUM>. Moreover, the guide wall <NUM> can be defined by the housing <NUM> or some other portion fixed within the housing <NUM>.

In some examples, the guide wall <NUM> may have a smooth and continuous inner surface that faces and extends about the spool <NUM>. In the illustrated embodiment, the guide wall <NUM> includes a rim <NUM> and a plurality of guide projections <NUM> that extend radially inward from the rim <NUM> toward the spool <NUM> and are circumferentially spaced about the spool <NUM>, the guide projections <NUM> being separated by intermediate wall recesses <NUM>. The alternating projections <NUM> and wall recesses <NUM> can reduce the total amount of surface contact between the guide wall <NUM> and guide wire <NUM> (as compared to a guide wall <NUM> with a smooth and continuous inner surface), thereby reducing the amount of frictional resistance the guide wall <NUM> exerts on the guide wire <NUM> as the guide wire <NUM> is dispensed from or accumulated about the spool <NUM>. Lubricants, coatings and other mechanisms and techniques for reducing friction forces can also be used in the device. Lubricants and coatings may include PTFE, FEP, silicone or other oils, etc..

As yet another example, the clearance device <NUM> can include a guide conduit <NUM> (also shown in <FIG>) defining a confined path within the housing <NUM> for directing the guide wire <NUM> between the spool <NUM> and roller assembly <NUM>. The guide conduit <NUM> can include a pair of conduit walls <NUM> (e.g., defined by the housing <NUM>) that extend substantially parallel to each other and define a conduit channel <NUM> therebetween for the guide wire <NUM>. In the illustrated embodiment the guide conduit <NUM> extends substantially tangentially from the guide wall <NUM> and the spool circumference so that the guide wire <NUM> can follow a smooth path through the conduit <NUM> as it is being dispensed from or accumulated on the spool <NUM>. The guide conduit <NUM> can further include a plurality of guide projections <NUM> that extend from each conduit wall <NUM> into the conduit channel <NUM>, and which are spaced along the conduit channel <NUM> to define a plurality of conduit recesses <NUM> therebetween. Similar to the guide projections <NUM> and wall recesses <NUM> of the guide wall <NUM> described above, the alternating guide projections <NUM> and conduit recesses <NUM> of the conduit walls <NUM> can reduce the total amount of surface contact between the guide conduit <NUM> and guide wire <NUM>, thereby reducing the amount of frictional resistance the guide conduit <NUM> may assert on the guide wire <NUM> as the guide wire <NUM> translates through the guide conduit <NUM>.

As shown in <FIG>, similar to the guide projections <NUM>, <NUM> and wall/conduit recesses <NUM>, <NUM> in the guide wall <NUM> and conduit walls <NUM> that reduce contact area and thus friction forces, a shelf <NUM> of a spool compartment <NUM> includes a plurality of recesses <NUM>. Similar recesses can also be provided on an opposing surface (not shown) of the cover plate <NUM> (<FIG>), which provide reduced surface contact with the spool <NUM>. The recesses reduce surface area of contact, and thus, friction forces. In other words, when the spool <NUM> rotates between the shelf <NUM> and the cover plate <NUM>, the reduced surface contact between the spool <NUM>, shelf <NUM>, and cover plate <NUM> provided by the recesses <NUM> in both the shelf <NUM> and cover plate <NUM> results in reduced friction and reduced resistance to rotation of the spool <NUM>. Further, when the spool <NUM> rotates between the shelf <NUM> and the cover plate <NUM>, the reduced surface contact between the guide wire <NUM>, shelf <NUM>, and cover plate <NUM> provided by the recesses <NUM> in both the shelf <NUM> and cover plate <NUM> results in reduced friction and reduced resistance to rotation of the spool <NUM>. The shelf <NUM>, guide wall <NUM>, spool <NUM> and cover plate <NUM> define the spool compartment <NUM> in which the guide wire <NUM> is contained during spooling and unspooling. The recesses <NUM> on the shelf <NUM> can also serve to collect any debris or particulate that might be carried into the compartment <NUM> on the wire <NUM>, such as dried blood. For example, dried blood residue may be carried into the spool compartment <NUM> via the guide wire <NUM>, which may be removed from the guide wire <NUM> when it is wound on the spool <NUM>. The dried blood residue may collect in the recesses <NUM> so as to be removed from moving surfaces. Similar recesses <NUM> (i.e. illustrated in <FIG>) can also be provided in the guide conduit <NUM> that leads into the spool compartment <NUM> as well as other areas of wire contact. In another embodiment, the plurality of recesses <NUM> of the shelf <NUM> may be replaced with guide projections, similar to the guide projections <NUM> and <NUM> in the guide wall <NUM> and conduit walls <NUM>, respectively. Such projections on the shelf would reduce surface contact between the spool <NUM> and the shelf, which leads to reduced friction and reduced resistance to rotation of the spool <NUM>. In another embodiment, the guide projections <NUM> and wall recesses <NUM> in the guide wall <NUM> may be replaced with recesses, similar to the recesses <NUM> of the shelf <NUM>. These recesses would reduce surface contact between the guide wire <NUM> and the guide wall <NUM>, which leads to reduced friction and reduced resistance to rotation of the spool <NUM>. As noted above, lubricants, coatings and other mechanisms and techniques for reducing friction forces can also be used in the device. Lubricants and coatings may include PTFE, FEP, silicone or other oils, etc..

Referring back to <FIG>, the clearance device <NUM> can include a control system <NUM> configured to control operation of the roller assembly <NUM> (e.g., via the motor <NUM>) to advance or retract the guide wire <NUM>. In particular, the control system <NUM> can include a controller <NUM> such as a microprocessor that is in communication with the motor <NUM> and can selectively operate the motor <NUM> to rotate the first and second rollers <NUM>, <NUM> and translate the guide wire <NUM> through the nip <NUM>. The control system <NUM> can further include a user interface <NUM> in communication with the controller <NUM> that enables a user to interact with the control system <NUM> to control operation of the roller assembly <NUM>. The user interface <NUM> can include a display, a touch-screen, one or more switches or buttons, or any other feature that enables a user to interact with the control system <NUM> and control operation of the roller assembly <NUM>. The display can supply information to the user, such as position of the clearance member(s) <NUM>, direction of travel, etc. One example of a user interface is shown in <FIG>.

The controller <NUM> can be configured to operate the roller assembly <NUM> to advance or retract the guide wire <NUM> according to one or more predetermined stroke cycles. A 'stroke' can correspond to an actuation of the guide wire <NUM> from an advanced state to a retracted state and back to the advanced state. Alternatively, a stroke can correspond to an actuation of the guide wire <NUM> from a retracted state to an advanced state and back to the retracted state. In a further alternative, a stroke can correspond to actuation of the guide wire <NUM> only between the retracted and advanced states, or vice versa. The precise scope of actuation of the guide wire <NUM> constituting a stroke in a particular case may be determined in the judgment of the clinicians responsible for patient care. In that regard, a 'stroke' as used here can refer to any movement or sequence of movements of the guide wire <NUM>, via advancement or retraction thereof through the nip <NUM>, that can be executed by operation of the motor <NUM> (or motors if more than one is used) at successive or user-selected time intervals, or at selected moments in time.

The controller <NUM> can be configured to stroke the guide wire <NUM> according to a predetermined stroke cycle. For instance, in one example stroke cycle, the guide wire <NUM> can be stroked intermittently for a set number of strokes within a set period of time, wherein the time interval between strokes can be controlled. In another example, the guide wire <NUM> can be stroked continuously for a set number of strokes with no or substantially no time interval between strokes. In yet another example, the guide wire <NUM> can be stroked a single time, for example on demand based on a user input. The controller <NUM> can be configured to stroke the guide wire <NUM> according to a variety of different stroke cycles.

The user interface <NUM> can enable a user to initiate and/or terminate a stroking operation of the guide wire <NUM>. Moreover, the user interface <NUM> can enable a user to adjust the parameters of a predetermined stroke cycle such as, for example, how many times the guide wire <NUM> should be stroked, the time interval between strokes, a position of the guide wire <NUM> in the retracted state, or a position of the guide wire <NUM> in the advanced state. The interface <NUM> further can enable the user to select the speed at which the guide wire <NUM> is stroked; i.e. the speed at which it is advanced and/or retracted into/from the medical tube. Still further, the user interface <NUM> can display one or more operating parameters of a stroking operation such as, for example, the current position and/or direction of the guide wire <NUM>, the current position and/or direction of the clearance member(s) <NUM>, whether the guide wire <NUM> and clearance member(s) <NUM> are moving or stationary, the speed of the guide wire <NUM> and clearance member(s) <NUM>, and cycle indicators, such as the number of completed strokes, or the duration for which a stroking operation has been running.

In some embodiments, the control system <NUM> can include one or more sensors for detecting one or more operating parameters of the clearance device <NUM>. For instance, as shown in <FIG> and <FIG> the clearance device <NUM> can include a magnet <NUM> that is fixed to the spool <NUM> such that the magnet <NUM> is rotatable with the spool <NUM> about the spool axis Y<NUM>. Meanwhile, the control system <NUM> can include an encoder <NUM> (e.g. a Hall effect sensor) that is configured to detect a rotary position of the magnet <NUM> about the spool axis Y<NUM>. In this manner, the control system <NUM> can detect the rotary position and/or number of revolutions or rotational speed or direction of the spool <NUM> about the spool axis Y<NUM>, which can indicate the degree to which the guide wire <NUM> has been advanced or retracted, the current direction state of its movement, its rate (speed) of advancement or withdrawal, etc. Notably, many of these same parameters can be detected by inference based on the rotational speed of the rollers <NUM>, <NUM>. The rotational speed of the roller can be measured directly or can be inferred based on operation of the motor <NUM>. By comparing the rotational speed of the rollers <NUM>, <NUM> with the measured rotational speed and other parameters of the spool <NUM>, certain faults may be detected in order to generate an alarm or other output. For example, if the guide wire <NUM> is stuck due to obstruction in the medical tube <NUM> and therefore is not moving despite operation of the rollers <NUM>, <NUM>, the spool <NUM> will not move, and thus the spool <NUM> will not rotate. Mis-matched rotations detected between the rollers and the spool can be used to trigger an obstruction alarm to notify clinicians that corrective action is required.

In addition or alternatively to the encoder <NUM>, the control system <NUM> can include various other types of sensors that detect other types of parameters such as, for example, the rotary position of the first roller <NUM> and/or second roller <NUM>, the duration in which the motor <NUM> has been operated, or a torque being applied to the first roller shaft <NUM> and/or second roller shaft <NUM>. The control system <NUM> can include a variety of different sensors without departing from the scope of this disclosure. Such sensors can be used to detect parameters and generate data that can be used by the controller or by a remote computer (e.g. linked via cable or wirelessly) to infer clinical conditions. For example, the torque required to drive the guide wire <NUM> past an obstruction may be used to infer the composition or other features of the obstruction. The torque profile as the guide wire <NUM> is being advanced or withdrawn through the medical tube <NUM> may be used to infer the location of an obstruction within that tube, which might not otherwise be visible because it is located within a portion of the tube located inside a patient's body.

The sensor(s) of the control system <NUM> can be in communication with the controller <NUM>, which can be configured to selectively operate the roller assembly <NUM> based on the operating parameter(s) detected by its sensor(s). For instance, the controller <NUM> can be configured to operate the roller assembly <NUM> based on the rotary position detected by the encoder <NUM> described above. In particular, a predetermined stroke cycle can be initiated with the user interface <NUM>, and the controller <NUM> can execute the stroke cycle, using the rotary position detected by the encoder <NUM> to determine when the guide wire <NUM> has reached an advanced or retracted state of the cycle.

In some examples, the control system <NUM> can include one or more alarms <NUM> for notifying a user about a particular circumstance. An alarm may correspond to, for example, a speaker that is operable to output a noise, or a diode that is operable to output a light. Each alarm <NUM> may be in communication with the controller <NUM>, which can operate the alarm <NUM> to generate an output in response to a particular condition detected by the sensor(s) of the control system <NUM>. For example, the controller <NUM> can operate an alarm <NUM> to generate an output if a torque detected in the first roller shaft <NUM> and/or second roller shaft <NUM> exceeds a predetermined threshold, or if a rotary position detected by the encoder <NUM> indicates that the spool <NUM> is improperly rotating (or not rotating). The control system can output various alarms, using various means, for indicating various circumstances detected by its sensor(s). For example, the control system may provide an alarm to a user via the user interface <NUM>.

Additionally, the control system <NUM> can facilitate remote control and monitoring of the device <NUM>. The control system <NUM> can be connected to a communication network, such as a wireless communication network, so that the device <NUM> can be monitored and/or controlled via a remote device, such as a computer or mobile device, e.g., a phone or tablet. Accordingly, any alarms <NUM> can be communicated over the network in order to send an alert to a device that may be in a remote or different location than the device <NUM>. In addition to the alarms described above, data regarding usage and current or past states of the device <NUM> may be transmitted over the network. Data from various sensors in the device <NUM> can be collected in order to monitor the status and performance of the device <NUM>. Examples of what can be monitored and/or controlled include: actuation cycles, drainage volume, location of clearance member, direction of movement of clearance member, pressure of system, battery power and status, alerts, alarms, errors, and fault codes. Also physiologic parameters such as drainage volumes and rates, air leak from lungs, CO<NUM> levels, ultrasound or echo data, drainage fluid parameters, hematocrit, activated clotting time, etc. can be monitored and/or controlled via the communication network. Moreover, the control system <NUM> can be configured to automatically change a status of the device <NUM> upon detecting a predetermined condition.

In some embodiments, the clearance device <NUM> can include a power supply <NUM> that can supply power to one or more of the features described above (e.g., the motor <NUM> and control system <NUM>). The power supply <NUM> can include a battery holder <NUM>, and one or more batteries <NUM> that can be inserted into the battery holder <NUM> to make electrical contact with battery terminals of the battery holder <NUM>. However, the power supply <NUM> may include other means for supplying power such as, for example, a power cord that can be connected to an electrical outlet, or a receiver that can receive power wirelessly from a transmitter via an inductive coupling.

Turning to <FIG>, the clearance device <NUM> can further include a power circuit <NUM> that can establish communication between the power supply <NUM> and the feature(s) requiring power. The power circuit <NUM> can include one or more wires, contacts, switches, or other circuit components for establishing communication along the power circuit <NUM>. The power circuit <NUM> illustrated in <FIG> is schematic and configured to establish communication between the power supply <NUM>, motor <NUM>, and control system <NUM>. However, it is to be appreciated that the power circuit <NUM> in <FIG> is merely an example, and may include alternative or additional paths and/or components in other examples.

In some examples, the power circuit <NUM> can be configured to enable selective communication between the power supply <NUM> and the powered feature(s). For example, the power circuit can include a first contact <NUM>, a second contact <NUM>, and a switch <NUM> that is movable relative to the first and second contacts <NUM>, <NUM> to enable selective communication between the first and second contacts <NUM>, <NUM> to selectively close the power circuit <NUM> between the first and second contacts <NUM>, <NUM>.

As shown in <FIG> and <FIG>, the first and second contacts <NUM>, <NUM> of the power circuit <NUM> can be fixed within the housing <NUM>. In particular, the first and second contacts <NUM>, <NUM> can be fixed to the partition wall <NUM> located within the housing <NUM>. Meanwhile, the carriage <NUM> described above can include a conductive portion <NUM> that corresponds to the switch <NUM> of the power circuit <NUM>. The contacts <NUM>, <NUM> and conductive portion <NUM> are arranged such that when the carriage <NUM> is in its disengaged position, the conductive portion <NUM> will be spaced from one or both contacts <NUM>, <NUM> such that the power circuit <NUM> is open between the contacts <NUM>, <NUM>. Conversely, when the carriage <NUM> is in its engaged position, the conductive portion <NUM> will connect with and establish communication between both contacts <NUM>, <NUM>, thereby closing the power circuit <NUM> between the contacts <NUM>, <NUM>. In this manner, the power circuit <NUM> can be opened when the carriage <NUM> is in its disengaged position, in order to preserve battery life of the power supply <NUM> and/or prevent undesirable operation of the roller assembly <NUM> when disengaged from the guide wire <NUM>. Further, when the spring <NUM> is a foam cylinder it may prevent accidental closure of the electronic circuit during use, transit, and storage of the device.

However, it is to be appreciated that the contacts <NUM>, <NUM> and switch <NUM> of the power circuit <NUM> can be fixed to other features of the clearance device <NUM> without departing from the scope of the disclosure. For example, the contacts <NUM>, <NUM> may be fixed to the carriage <NUM> and the switch <NUM> may correspond to a conductive portion of the wall <NUM> or some other feature of the device <NUM>. Alternatively, the clearance device <NUM> may include a user-accessible power switch somewhere else along the housing <NUM>, untethered to the carriage <NUM> or its operation.

As noted above, the housing <NUM> is designed to preserve a sterile field for the guide wire <NUM> and the roller assembly <NUM>. In particular, as shown in <FIG> and <FIG> the housing <NUM> defines an interior <NUM> wherein the guide wire <NUM> and rollers <NUM>, <NUM> of the roller assembly <NUM> reside. The housing <NUM> forms a barrier between its interior <NUM> and exterior <NUM> so that the interior <NUM> can be sterilized and preserved in its sterilized state for the guide wire <NUM> and rollers <NUM>, <NUM>. Moreover, the housing <NUM> can contain one or more other features of the device <NUM> such as, for example, the motor <NUM>, spool <NUM>, power supply <NUM>, and controller <NUM> described above.

A plurality of compartments can be defined within the housing <NUM> for the various features contained therein. For example, the housing <NUM> can define a roller compartment <NUM> that contains the first and second rollers <NUM>, <NUM>, a spool compartment <NUM> that contains the spool <NUM>, and a motor compartment <NUM> that contains the motor <NUM> and controller <NUM>.

Each compartment <NUM>, <NUM>, <NUM> can be defined by one or more walls of the device <NUM>. For example, the roller compartment <NUM> can be defined by the shell halves <NUM>, <NUM> of the housing <NUM>, and the partition wall <NUM> of the roller assembly <NUM> when fixed within the housing <NUM>. Moreover, the spool compartment <NUM> can be defined by one of the shell halves (e.g., shell half <NUM>), the guide wall <NUM> described above, and a cover plate <NUM> fixed to the guide wall <NUM> that covers the spool compartment <NUM>. Furthermore, the motor compartment <NUM> can correspond to the remaining space within the housing <NUM> that is defined by the shell halves <NUM>, <NUM>, the partition wall <NUM>, the guide wall <NUM>, and the cover plate <NUM>. However, it is to be appreciated that each compartment <NUM>, <NUM>, <NUM> can be defined by other various walls of the housing <NUM> for the clearance device <NUM>.

In examples wherein a plurality of compartments is defined within the housing <NUM>, each compartment can be isolated from one or more other compartments such that fluid communication is inhibited therebetween, and that differential pressures are maintained therebetween. For example, the cover plate <NUM> can isolate the spool compartment <NUM> from the motor compartment <NUM>, and a seal member <NUM> (e.g., gasket) can be provided along the guide wall <NUM> between the cover plate <NUM> and guide wall <NUM> to inhibit fluid communication between the guide wall <NUM> and cover plate <NUM>. As another example, the partition wall <NUM> can separate the roller compartment <NUM> from the motor compartment <NUM>. Moreover, a seal member <NUM> can be provided about the perimeter of the partition wall <NUM> to inhibit fluid communication between the partition wall <NUM> and the housing <NUM>. Furthermore, another seal member <NUM> (see <FIG>) can be provided about the first roller shaft <NUM> to inhibit fluid communication through the roller shaft opening <NUM> of the partition wall <NUM> separating the roller and motor compartments <NUM> and <NUM>.

However, it is to be appreciated that each compartment can be isolated from one or more other compartments in a variety of different manners without departing from the scope of the disclosure. As each compartment can be isolated, it is to be appreciated that one or more compartments may remain sterile, while others do not remain sterile. Furthermore, some compartments may actually be in communication with each other. For example, the roller compartment <NUM> and spool compartment <NUM> can be in communication with each other through the guide conduit <NUM> described above.

As shown in <FIG>, the clearance device <NUM> can be coupled to the medical tube <NUM> such that the guide wire <NUM> extends through the port <NUM> of the housing <NUM> and into the medical tube <NUM> through its proximal opening <NUM>. Moreover, as discussed above, the clearance device <NUM> can be operated to advance and retract the guide wire <NUM> within the medical tube <NUM>. In its fully retracted state, the guide wire <NUM> may be completely removed from the medical tube <NUM> and may reside completely within the housing <NUM> of the clearance device <NUM>. Alternatively, the guide wire <NUM> may reside partially within the housing <NUM> and may extend partially into the medical tube <NUM>. Meanwhile, in its fully advanced state, the guide wire <NUM> may extend through the medical tube <NUM> and out of its distal opening <NUM>. Alternatively, the guide wire <NUM> may extend only partially through the medical tube <NUM> such that the guide wire <NUM> does not extend through its distal opening <NUM>. It is to be appreciated that the guide wire <NUM> may assume a variety of different positions in its fully retracted and advanced states, the precise locations of which can be selected by the clinicians when configuring the clearance device <NUM> for a particular patient, pre-programmed by the manufacturer, or determined by physical stops, electrical sensors, or some combination thereof. Accordingly, it will be appreciated that a clinician or user can tune custom stroke lengths, as well as specify particular fully advanced and fully retracted positions for the guide wire <NUM> and any clearance member <NUM> attached thereto within the medical tube. Accordingly, the fully inserted position in a given, user- or pre-selected configuration need not be such that the distal end of the guide wire <NUM> or a clearance member <NUM> is received all the way adjacent to the distal end of the medical tube <NUM>; and likewise the fully withdrawn position in a given, user- or pre-selected configuration need not be such that the distal end of that guide wire <NUM>, or a clearance member <NUM>, is located all the way adjacent to the proximal end of the medical tube <NUM>, or withdrawn completely therefrom. Both fully inserted and fully withdrawn positions for a given stroke cycle can be defined at respective positions relative to the medical tube not corresponding to its distal and proximal ends.

In order to couple the clearance device <NUM> to the medical tube <NUM>, the clearance device <NUM> can include a coupling portion <NUM> that defines its port <NUM>. The coupling portion <NUM> can be defined by the housing <NUM> in a variety of configurations for directly or indirectly coupling to the medical tube <NUM>. For example, the coupling portion <NUM> can have a frustoconical body that can be inserted directly into the proximal opening <NUM> of the medical tube <NUM>. In another example, the coupling portion <NUM> can be indirectly coupled to the medical tube <NUM> via a connector <NUM>, which is described in further detail below. At least one of the coupling portion <NUM> and the connector <NUM> includes a cleaning and/or lubricating element configured to wipe the guide wire <NUM> before it enters the device housing <NUM>. For instance, the cleaning/lubricating element can be made from a foam material and configured to clear any blood residue from the guide wire <NUM>. Additionally or alternatively, a reservoir can be coupled to the cleaning/lubricating element that includes at least one of a cleaning agent and/or a lubricating agent that is applied to the guide wire <NUM> during movement. The lubricant aids in reducing friction thereby reducing the required force to advance and retract the wire which in turn reduces power consumption. The cleaning/lubricating element can also be provided within the device housing <NUM>.

As shown in <FIG>, the connector <NUM> includes a body <NUM> that defines multiple branches including a distal branch <NUM>, a proximal branch <NUM>, a drain branch <NUM>, and an access branch <NUM>. Each branch <NUM>, <NUM>, <NUM>, <NUM> defines an opening <NUM> and a passageway <NUM> that extends into the body <NUM> from its opening <NUM>. Moreover, the passageways <NUM> of the branches <NUM>, <NUM>, <NUM>, <NUM> intersect at a hub chamber <NUM> within the body <NUM> such that the passageways <NUM> can communicate with each other via the hub chamber <NUM>.

In the illustrated embodiment, the passageways <NUM> of the distal branch <NUM> and the proximal branch <NUM> are coaxial with a first connector axis Z<NUM>, and the passageways <NUM> of the drain branch <NUM> and the access branch <NUM> are coaxial with a second connector axis Z<NUM> that is substantially perpendicular to and intersects the first connector axis Z<NUM>. However, the first and second connector axes Z<NUM>, Z<NUM> may be oblique to each other, and may not necessarily intersect with each other. Furthermore, one or both of the passageways <NUM> of the distal branch <NUM> and proximal branch <NUM> may be skewed relative to the first connector axis Z<NUM>, and one or both of the passageways <NUM> of the drain branch <NUM> and access branch <NUM> may be skewed relative to the second connector axis Z<NUM>. The passageways <NUM> can comprise a variety of different alignments without departing from the scope of the disclosure. Moreover, the number of passageways <NUM> can be varied as desired. For example, branch <NUM> may not be present in some configurations.

The distal branch <NUM> of the connector <NUM> can be directly coupled to the medical tube <NUM> such that the passageway <NUM> of the distal branch <NUM> is in fluid communication with the medical tube <NUM> via the opening <NUM> of the distal branch <NUM>. Moreover, the proximal branch <NUM> can be directly coupled to the coupling portion <NUM> of the device <NUM> such that the passageway <NUM> of the proximal branch <NUM> is in fluid communication with the interior <NUM> of the device <NUM> via the opening <NUM> of the proximal branch <NUM>. In this manner, the guide wire <NUM> can extend from the clearance device <NUM> through the passageways <NUM> of the distal and proximal branches <NUM>, <NUM> of the connector <NUM> and into the medical tube <NUM>. Moreover, because the passageways <NUM> of the distal and proximal branches <NUM>, <NUM> are coaxial with a common, linear axis (i.e., first connector axis Z<NUM>), the guide wire <NUM> can extend through the connector <NUM> along a linear path without having to navigate through any sharp bends or curves.

The drain branch <NUM>, meanwhile, can be directly coupled to a drain tube <NUM> (see <FIG>), which can drain fluids or other materials that are drawn into the connector <NUM> from the medical tube <NUM>. In some examples, the drain tube <NUM> can be connected to a vacuum source, which will apply a vacuum to the drain tube <NUM> that facilitates the drawing of fluids or other materials from the medical tube <NUM> and through the connector <NUM> into the drain tube <NUM>. In this manner, materials and fluids withdrawn from the medical tube <NUM> are withdrawn from the connector <NUM> via a pathway distinct from that leading to the clearance device <NUM>, such that fouling and obstructing material is not drawn back into that device <NUM>.

The access branch <NUM> can provide access to the interior of the connector <NUM> through its opening <NUM> and passageway <NUM>. Such access may be achieved by intermittent or continuous connection through the access branch <NUM> and is desirable for clearing obstructions within the connector <NUM> and/or drain tube <NUM>, delivering or removing fluids, gases, or other materials into the medical tube <NUM> or drain tube <NUM> through the access branch <NUM> and distal branch <NUM>, or other various purposes. Clots, blood, gases, and/or other fluids can be withdrawn through the connector for purposes of clearing an obstruction and/or sampling for testing. Additionally, in some examples, a cleaning fluid can be introduced into the connector <NUM> through the access branch <NUM> to dislodge obstructions in the connector <NUM>. The fluid and obstructions can then be drained via the drain branch <NUM> and drain tube <NUM>. In other examples, a pressure resulting from the injection or withdrawal of a fluid and/or gas into the connector <NUM> through the access branch <NUM> is used to clear obstructions from the medical tube <NUM> or the drain tube <NUM>. That is, upon injecting a fluid the air and other gas within the drain branch and the medical tube becomes compressed behind any present obstruction. If a substantially incompressible liquid (e.g. water or aqueous solution) is injected, then the increased gas pressure will be due to the consumption by the injected liquid of available air space. Alternatively, if air or another gas (or combination of gases) is/are injected, then the increased gas pressure will be due to the addition of additional gaseous mass within the same volume behind the obstructing debris. In either case, the resulting additional pressure, itself or in combination with other features herein disclosed, can be useful to dislodge occluding debris within the medical tube <NUM>. Conversely, withdrawal of fluid in front of (i.e. toward the proximal end of the tube <NUM>) obstructing debris can yield a negative pressure in the associated tube space, which will tend to suck the obstructing debris out from the tube <NUM>.

The connector <NUM> can include a valve assembly <NUM> that is operable to provide selective or continuous communication through the access branch <NUM>. The valve assembly <NUM> can include a stem body <NUM> inserted into the passageway <NUM> of the access branch <NUM>. The stem body <NUM> is a tubular body that defines a valve passage <NUM> extending through the stem body <NUM>. Moreover, the stem body <NUM> is sized such that an outer diameter of the stem body <NUM> is substantially similar to the internal diameter of the access branch <NUM>. In this manner, a seal can be established between the outer surface of the stem body <NUM> and the inner surface of the access branch <NUM>. Meanwhile, the valve assembly <NUM> can further include a cap <NUM> that can be threadably connected to the stem body <NUM>. The cap <NUM> includes a plug member <NUM> that will be inserted into the valve passage <NUM> of the stem body <NUM> when the cap <NUM> is completely threaded onto the stem body <NUM>, thereby inhibiting fluid communication through the valve passage <NUM> and access branch <NUM>. As the cap <NUM> is loosened from the stem body <NUM>, the plug member <NUM> will be withdrawn from the valve passage <NUM> and fluid communication will be enabled through the valve passage <NUM> and access branch <NUM>. The cap <NUM> can be completely removed from the stem body <NUM> to provide maximum communication through the valve passage <NUM> and access branch <NUM>. However, it is to be appreciated that the valve assembly can be self-sealing without cap <NUM>. Additionally, the access branch <NUM> and/or valve may be integral with the connector <NUM>.

The valve assembly <NUM> described above can thus provide selective or continuous communication through the access branch <NUM>, by loosening or tightening the threaded connection of its stem body <NUM> and cap <NUM>. In this manner, the access branch <NUM> can be opened and closed as desired to provide selective access to the interior of the connector <NUM>. However, it is to be appreciated that the connector <NUM> can include a variety of different valve assemblies for providing selective communication through the access branch <NUM>. For example, the valve assembly <NUM> may be connected to a fluid or gas source in order to automatically introduce or remove materials (fluids, gas, solids, semi-solids) from the device <NUM> based on data from the various sensors in the device <NUM>. The fluid or gas source may be a reservoir containing a sterile fluid or gas, filter atmospheric air, etc. If the sensors detect an obstruction in any of the tubes or pathways, the control system <NUM> can be configured to automatically introduce the fluid or gas from the fluid or gas source into the tube or pathway via the valve assembly <NUM>. As noted above, the distal branch <NUM> of the connector <NUM> can be directly coupled to the medical tube <NUM>, and the proximal branch <NUM> can be directly coupled to the coupling portion <NUM> of the clearance device <NUM>. Moreover, the drain branch <NUM> can be directly coupled to a drain tube <NUM>. Each of these branches <NUM>, <NUM>, <NUM> can have a variety of different configurations for directly coupling to their associated structures. For instance, each branch <NUM>, <NUM>, <NUM> can have a frustoconical body that can be inserted into its associated structure to couple the branch thereto.

Preferably, the proximal branch <NUM> of the connector <NUM> is configured to be rotatably coupled to the coupling portion <NUM> of the clearance device <NUM> such that the connector <NUM> is rotatable relative to the coupling portion <NUM> about the first connector axis Z<NUM>. For example, the proximal branch <NUM> can be inserted into the coupling portion <NUM> of the clearance device <NUM>, and one or more seals, such as O-rings <NUM>, or any other suitable seal can be provided around the proximal branch <NUM> that establish a seal between the proximal branch <NUM> and the coupling portion <NUM> and permit the proximal branch <NUM> to rotate relative to the coupling portion <NUM> while maintaining their seal. This rotatable coupling of the connector <NUM> and coupling portion <NUM> can permit the connector <NUM> to be rotated relative to the clearance device <NUM> to accommodate different placements of that device <NUM>, for example to ensure that the drain tube <NUM> has a downward orientation for gravity purposes.

However, it is to be appreciated that the proximal branch <NUM> of the connector <NUM> can be rotatably coupled to the coupling portion <NUM> of the clearance device <NUM> in a variety of different ways without departing from the scope of this disclosure. Furthermore, one or both of the distal branch <NUM> and drain branch <NUM> of the connector <NUM> may be similarly rotatably coupled to the medical tube <NUM> and drain tube <NUM>.

The connector <NUM> can include one or more guide bodies <NUM> within its proximal branch <NUM> to center the guide wire <NUM> through the connector <NUM>. Each guide body <NUM> can be tubular in shape, with an outer diameter that closely approximates the inner diameter of the proximal branch <NUM>, and a through-hole <NUM> that is coaxial with the first connector axis Z<NUM>. The diameter of the through-hole <NUM> can closely approximate the diameter of the guide wire <NUM>, although the diameter may be larger such that a small clearance is provided between the guide wire <NUM> and guide body <NUM>. Alternatively, the diameter of the through-hole <NUM> can be smaller than the guide wire <NUM> in order to create an interference fit with the guide wire <NUM>.

In the illustrated embodiment, the connector <NUM> includes three guide bodies <NUM> (260a, 260b, and 260c) arranged within its proximal branch <NUM> that are aligned along the first connector axis Z<NUM>. The middle guide body 260b is made of thermoplastic polyurethane or some other material such as, silicone, other types of rubber, thermoplastic elastomers, etc. that can establish a seal between the guide wire <NUM> and proximal branch <NUM>. The middle guide body 260b acts as a septum forming a seal with the guide wire <NUM> as it translates that can preserve a vacuum within the connector <NUM> from the drain tube <NUM>. Meanwhile, the outer guide bodies 260a, 260c can be made of Teflon or some other material such as PEEK, acetal plastic, etc. that can minimize friction between the guide bodies <NUM> and guide wire <NUM> passing through. The guide bodies <NUM> act to seal and separate the housing <NUM> from a blood path. In addition, when the guide wire <NUM> passes through the guide bodies <NUM>, the internal diameter of the guide bodies <NUM> are configured to wipe the guide wire <NUM> clean to limit travel of blood or other material carried by the guide wire <NUM> into the device housing <NUM>.

The number and arrangement of guide bodies <NUM> may vary in other examples, as well as the materials of the guide bodies <NUM>. A seal is provided between an outer portion of the guide bodies <NUM> and the connector <NUM>, to restrict fluid flow around and between the guide bodies <NUM>. This seals assists in the maintenance of a vacuum in the tube system, mitigates the ingress of fluids into the enclosure, and maintains sterility of the medical tube circuit. The seals can be achieved by positioning a seal member between one or more of the guide bodies <NUM> and the connector <NUM>. The seal member can be RTV silicone, O-rings, or other means that are integral or coupled to at least one of the guide bod(ies) <NUM> or the connector <NUM>.

The clearance device <NUM> described above can be a modular, self-contained unit including all of the foregoing features. In the illustrated embodiments, the modular clearance device <NUM> is a portable device that can be placed on a patient's body, for example, preferably close to where the medical tube <NUM> exits the body. To ensure that the device <NUM> remains properly seated on the patient's body, the device <NUM> can include a substrate <NUM> (see <FIG>) having adhesive, e.g. an acrylic adhesive designed for skin contact or a hydrocolloid type material, on its exposed surface that can be adhered to the patient's body. The substrate <NUM> preferably is made from foam or some other flexible material that can flex to accommodate variable, curved or irregular profiles of the patient's body while remaining adhered to the housing <NUM> at its opposite surface. In another embodiment, the adhesive pad may have a carrier or other features that allow securement and detachment of the device <NUM> to and from the patient without removing and reapplying the adhesive pad. The carrier may be plastic and allow snap connection or could have other fastening mechanisms, such as a hook and loop fasteners. Alternatively, the device <NUM> may be secured to the patient via a strap, such as a belt strap, or as part of a garment, such as a vest that can secure the device within pockets, loops, or other features. Or, the device <NUM> may not be coupled to the patient at all. The device <NUM> can be secured to other devices or equipment, such as walkers, beds, IV poles, etc. through similar fastening mechanisms discussed above.

As further shown in <FIG>, the housing <NUM> can have a contour designed to conform better to a patient's body (as compared to, for example, a flat profile). More specifically, the housing <NUM> can define a lower surface <NUM> that is intended to face and rest on the patient's body. The lower surface <NUM> can be concave so as to more naturally accommodate the curvature of a patient's body (for example the patient's leg or abdomen) against or to which it rests or is adhered in practice. One side of the substrate <NUM> described above can be adhered to this lower surface <NUM>, while the opposite side of the substrate <NUM> is available for adhesion to the patient's body, e.g. via medical-grade adhesive. In this manner, the housing <NUM> can be conveniently fixed, temporarily, to and against the patient's body.

The modular clearance device <NUM>, including the controller <NUM>, user interface <NUM>, roller assembly <NUM>, and spool <NUM> can be configured so that the device <NUM> is reusable between different patients. For example, the foam substrate <NUM> may be removable and discarded as a consumable item, and the clearance device <NUM> itself, including its housing <NUM> and all interior components, can be reprocessed for subsequent use with additional patients. Accordingly, the device <NUM> can be a modular, portable device usable successively for different patients, and can be conveniently stored and transported to different treatment sites or rooms within a hospital or other clinical setting. In such examples, the actuator <NUM> described above can be released from its locked state and returned to its second position after use with a patient, in order to return the carriage <NUM> to its disengaged position and enable fluid communication through the guide channel <NUM> for a sterilizing fluid to be introduced and/or evacuated into and/or from the housing <NUM>. In some embodiments, for single use or multi-use, the device <NUM> can have one or more battery compartments in which replaceable batteries can be accessed without compromising the sterile barrier or vacuum seal. Additionally or alternatively, the device <NUM> may include a mechanism for recharging internal batteries either through direct electrical connection or inductive charging.

Alternatively, the device <NUM> may be disposable so that after the device <NUM> is used with a patient, the device <NUM> may be discarded. Indeed, in such embodiments, the device <NUM> can include one or more locking features (e.g., the catch <NUM> described above) that prohibit the actuator <NUM> from returning to its second position, thus preventing a technician from re-establishing fluid communication through the guide channel <NUM> for a sterilizing fluid.

Claim 1:
A device for clearing obstructions from a medical tube (<NUM>), comprising:
a housing (<NUM>) defining an interior (<NUM>), an exterior (<NUM>), and a port (<NUM>) providing communication therebetween;
an elongated guide wire (<NUM>) residing at least partially within the housing (<NUM>);
a spool (<NUM>) within the housing (<NUM>) for dispensing and accumulating the elongated guide wire (<NUM>), the spool (<NUM>) being rotatable relative to the housing (<NUM>) about a spool axis; and characterized by
first and second rollers (<NUM>, <NUM>) adapted to define a nip (<NUM>) therebetween;
said guide wire (<NUM>) is adapted to extend through said nip (<NUM>) and is drivable for advancement and retraction thereof through said port (<NUM>) via rotation of said rollers (<NUM>, <NUM>).