Patent Description:
The disclosure relates generally to the field of medical devices and methods of using a medical device. More particularly, the disclosure relates to medical devices that include a trigger assembly for a rotatable catheter and methods of using a medical device that includes a trigger assembly for a rotatable catheter.

Medical devices such as implanted cardiac pacing systems, such as pacemakers and defibrillators, generally employ an implanted power source (e.g., pulse generator) and one more leads. The leads are attached to the pulse generator and the heart and include electrodes in direct contact with heart tissue to convey electrical stimulation of the heart muscle. Proper placement of the leads in the body is necessary to assure delivery of the electrical stimuli and accomplish electrical stimulation of the heart muscle. As a result, the leads are disposed within various portions of the body. For example, a lead can be positioned within an artery, a vein, or a chamber of the heart.

Subsequent to implantation, the body may react to the implanted cardiac pacing system by forming scar tissue along a lead and its associated electrode. While leads are generally designed
to be implanted permanently, there are instances in which it may be necessary to remove and/or replace a lead, such as when the patient develops an infection or the pacemaker or cardiac defibrillator has malfunctioned. The presence of any scar tissue, lesions, calcification, and/or plaque buildup around the lead and its associated electrode increases the difficultly associated with removing the lead.

Various lead removal devices have been developed to increase the efficiency of extracting an implanted lead. For example, some lead removal devices include a catheter and a dissecting tip disposed on the distal end of the catheter. The catheter is advanced over the lead and the dissecting tip assists with separating any lesions and calcifications from the lead such that it can be removed. However, these devices have drawbacks. For example, some lead extraction devices include drive mechanisms that have a minimal surface area that contacts the structure utilized to move a drive assembly between its first and second positions and/or include drive mechanisms that prevent a drive assembly from consistently alternating between a clockwise and a counterclockwise direction during use. These drawbacks increase the time required to complete a lead extraction procedure and the hand fatigue experienced by a user during completion of a procedure.

A need exists, therefore, for new and useful medical devices that include a trigger assembly for a rotatable catheter and methods of using a medical device that includes a trigger assembly for a rotatable catheter. <CIT> describes methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. <CIT> describes a rooter which includes a rotatable element, an actuator for causing the rotatable element to rotate, and a coupling feature for rotatably coupling an elongated medical instrument to the rotatable element. <CIT> describes an extraction device for removing an implanted structure, such as a cardiac lead, from a body vessel.

An aspect of the invention is set out in the independent claim and optional features are set out in the dependent claims. Methods for the treatment of the human or animal body by surgery or therapy are described as examples only.

Various example medical devices that include a trigger assembly for a rotatable catheter and methods of using a medical device that includes a trigger assembly for a rotatable catheter are described herein.

An example medical device that includes a trigger assembly for a rotatable catheter includes a housing, a catheter, a drive assembly, and a trigger assembly. The housing defines a chamber and a passageway in communication with the chamber. The catheter is partially disposed through the passageway and is rotatable relative to the housing. The drive assembly is disposed within the chamber and is moveable relative to the housing. Movement of the drive assembly results in rotation of the catheter. The trigger assembly is partially disposed within the chamber and includes a trigger, a drive initiator, a drive member, a flip drive, and a biasing member. The trigger is attached to the housing and is moveable between a first position and a second position relative to the housing. The drive initiator is attached to the trigger and is moveable between a first position and a second position relative to the trigger. The drive member is attached the drive initiator and is moveable relative to the trigger between a first position and a second position. The flip drive is attached to the trigger and is moveable between a neutral position, a first drive position, and a second drive position. The flip drive is in the neutral position when the drive initiator is in the first position. The flip drive is in the first drive position when the drive initiator is in the second position and the drive member is in the second position. The flip drive is in the second drive position when the drive initiator is in the second position and the drive member is in the first position. The biasing member is disposed within the chamber and biases the flip drive to the neutral position when the drive initiator is in the first position. The drive assembly moves relative to the housing when the flip drive is in the first drive position and the trigger is moved from its first position to its second position. The drive assembly moves relative to the housing when the flip drive is in the second drive position and the trigger is moved from its first position to its second position.

Another example medical device that includes a trigger assembly for a rotatable catheter includes a housing, a catheter, a drive assembly, and a trigger assembly. The housing defines a chamber and a passageway in communication with the chamber. The catheter is partially disposed through the passageway and is rotatable relative to the housing. The drive assembly is disposed within the chamber and is moveable relative to the housing. Movement of the drive assembly results in rotation of the catheter. The trigger assembly is partially disposed within the chamber and includes a trigger, a drive initiator, a drive member, a flip drive, and an extension spring. The trigger is attached to the housing and is moveable between a first position and a second position relative to the housing. The drive initiator is attached to the trigger and is moveable between a first position and a second position relative to the trigger. The drive member is attached the drive initiator and is moveable relative to the trigger between a first position and a second position. The flip drive is attached to the trigger and is moveable between a neutral position, a first drive position, and a second drive position. The flip drive is in the neutral position when the drive initiator is in the first position. The flip drive is in the first drive position when the drive initiator is in the second position and the drive member is in the second position. The flip drive is in the second drive position when the drive initiator is in the second position and the drive member is in the first position. The flip drive has a central portion, a first driver arm, and a second driver arm. Each of the first driver arm and the second driver arm is moveably attached to the central portion. Each of the first driver arm and second driver arm is attached to the central portion using a living hinge. The extension spring is attached to the flip drive and the trigger and biases the flip drive to the neutral position when the drive initiator is in the first position. The drive assembly moves relative to the housing when the flip drive is in the first drive position and the trigger is moved from its first position to its second position. The drive assembly moves relative to the housing when the flip drive is in the second drive position and the trigger is moved from its first position to its second position.

An example method, not forming part of the present invention, of using a first medical device that includes a trigger assembly for a rotatable catheter to remove a second medical device attached to a portion of a body of an animal where the medical device is disposed within a bodily passage of the body includes: obtaining a first medical device that has a housing, a catheter, a drive assembly, and a trigger assembly, the trigger assembly includes a trigger, a drive initiator, a drive member, a flip drive, a biasing member, and a retaining cap, the drive member is in a first position; introducing a portion of a second medical device disposed within a bodily passage of a body of an animal into a lumen defined by the catheter; applying a proximally-directed force on the second medical device while maintaining the position of the first medical device until the second medical device is disposed proximal to the catheter; applying a distally-directed force on the first medical device while applying proximally-directed force on the second medical device such that the first medical device is introduced into the bodily passage; continuing the application of a distally-directed force on the first medical device while applying proximally-directed force on the second medical device such that the first medical device is advanced into the bodily passage; applying a proximally-directed force on the drive initiator and the trigger while maintaining the position of the grip such that the drive member moves to a second position, the flip drive contacts a portion of the drive assembly, and the catheter rotates and dissects tissue from the second medical device; stopping the application of a proximally-directed force on the trigger; applying a distally-directed force on the first medical device while applying a proximally-directed force on the second medical device such that the first medical device is advanced into the bodily passage; applying a proximally-directed force on the second medical device while maintaining the position of the first medical device until the second medical device is withdrawn from the bodily passage; applying a proximally-directed force on the first medical device until the first medical device (e.g., catheter r) is withdrawn from the bodily passage.

Additional understanding of these example medical devices that include a trigger assembly for a rotatable catheter and methods of using a medical device that includes a trigger assembly for a rotatable catheter can be obtained by review of the detailed description, below, and the appended drawings.

The following detailed description and the appended drawings describe and illustrate various example embodiments of medical devices that include a trigger assembly for a rotatable catheter and methods of using a medical device that includes a trigger assembly for a rotatable catheter. The description and illustration of these examples are provided to enable one skilled in the art to make and use a medical device that includes a trigger assembly for a rotatable catheter and practice a method of using a medical device that includes a trigger assembly for a rotatable catheter. They are not intended to limit the scope of the claims in any manner. The invention is capable of being practiced or carried out in various ways and the examples described and illustrated herein are merely selected examples of the various ways of practicing or carrying out the invention and are not considered exhaustive.

<FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> illustrate an example medical device <NUM> that includes a trigger assembly <NUM>. The medical device <NUM> is a transvenous lead extraction device useful for removing implanted cardiac pacing leads in a minimally invasive procedure. The medical device <NUM> has a housing <NUM>, a catheter <NUM>, a drive assembly <NUM>, and the trigger assembly <NUM> is partially disposed within the housing <NUM>. In the illustrated embodiment, the trigger assembly <NUM> includes a trigger <NUM>, a drive initiator <NUM>, a drive member <NUM>, a flip drive <NUM>, a biasing member <NUM>, and a retaining cap <NUM>.

In the illustrated embodiment, the housing <NUM> defines a grip <NUM>, a chamber <NUM>, a passageway <NUM>, and a slot <NUM>. Each of the passageway <NUM> and the slot <NUM> is in communication with the chamber <NUM>. The catheter <NUM> is partially disposed through the passageway <NUM> defined by the housing <NUM>, is partially disposed within the chamber <NUM> defined by the housing <NUM>, defines a lumen <NUM>, and is rotatable relative to the housing <NUM> in a first direction <NUM> (e.g., clockwise) and a second direction <NUM> (e.g., counterclockwise). The drive assembly <NUM> is disposed within the chamber <NUM> and is moveable relative to the housing <NUM> such that movement of the drive assembly <NUM> results in rotation of the catheter <NUM>. In the embodiment illustrated, the drive assembly <NUM> is moveable relative to the housing <NUM> in a first direction <NUM> and a second direction <NUM> such that movement of the drive assembly <NUM> in the first direction <NUM> results in rotation of the catheter <NUM> in the first direction <NUM> and movement of the drive assembly <NUM> in the second direction <NUM> results in rotation of the catheter <NUM> in the second direction <NUM>. In the illustrated embodiment, the drive assembly <NUM> contacts the housing <NUM> and the catheter <NUM> and includes a gear assembly <NUM> and a drive belt <NUM>. While a particular drive assembly <NUM> that includes a gear assembly <NUM> and a drive belt <NUM> has been illustrated, any suitable drive assembly can be included in a medical device.

The trigger assembly <NUM> is partially disposed within the chamber <NUM> defined by the housing <NUM>. The trigger <NUM> is moveably attached to the housing <NUM> and is moveable between a first position <NUM> and a second position <NUM> relative to the housing <NUM>, as shown in <FIG>, upon the application, and removal, of an axial force on the trigger <NUM> directed toward the grip <NUM>. The trigger <NUM> is disposed through the slot <NUM> defined by the housing <NUM>, is partially disposed within the chamber <NUM> defined by the housing <NUM>, and is biased to the first position <NUM> using a coil member <NUM> that is attached to trigger <NUM> and the housing <NUM>. The trigger <NUM> has a lengthwise axis <NUM>, a handle <NUM>, a base <NUM>, a projection <NUM>, and defines a first recess <NUM>, a second recess <NUM>, a slot <NUM>, and a track <NUM>. The handle <NUM> extends from the base <NUM> and away from the housing <NUM>, is disposed outside the chamber <NUM> defined by the housing <NUM>, and is sized to be received by the hand of a user. The handle <NUM> includes a biasing member <NUM> that extends from the handle <NUM> toward the drive initiator <NUM> and biases the drive initiator <NUM> in the first position, as described in more detail herein. Alternative embodiments, however, can include a spring, or other component, between a handle and a drive initiator to bias the drive initiator in the first position. The base <NUM> is disposed within the chamber <NUM> defined by the housing <NUM>, has a lengthwise axis <NUM>, a first end <NUM>, a second end <NUM>, and receives the drive initiator <NUM>, the drive member <NUM>, the flip drive <NUM>, the biasing member <NUM>, and the retaining cap <NUM>, as described herein. The projection <NUM> extends from the base <NUM> and away from the first end <NUM> of the base <NUM>. Each of the first recess <NUM> and the second recess <NUM> extends into the base <NUM> and is sized to receive a portion of the retaining cap <NUM>. The first recess <NUM> is disposed between the second end <NUM> and the slot <NUM>. The second recess <NUM> is disposed between the slot <NUM> and the first end <NUM> of the base <NUM>. The slot <NUM> is disposed between the first recess <NUM> and the second recess <NUM>, has a first end <NUM> and a second end <NUM>, and is sized to receive a portion of the drive initiator <NUM>. The track <NUM> extends around the base <NUM> and mates with a portion of the housing <NUM> to maintain the position of the trigger <NUM> relative to the housing <NUM> along the lengthwise axis <NUM> of the trigger <NUM> and allow the trigger <NUM> to move relative to the housing <NUM> along the lengthwise axis <NUM> of the base <NUM> and within the slot <NUM> defined by the housing <NUM>.

The drive initiator <NUM> is moveably attached to the trigger <NUM> and is moveable between a first position <NUM> and a second position <NUM> relative to the trigger <NUM>, as shown in <FIG> and <FIG>. In the illustrated embodiment, the drive initiator <NUM> is partially disposed through the slot <NUM> defined by the trigger <NUM> and has a main body <NUM> and a post <NUM>. The main body <NUM> is disposed adjacent to the handle <NUM> of the trigger <NUM>. The post <NUM> extends from the main body <NUM>, through the slot <NUM> defined by the trigger <NUM>, and is disposed within the chamber <NUM> defined by the housing <NUM>. As shown in <FIG>, the drive initiator <NUM> is disposed a first distance <NUM> from the first end <NUM> of the base <NUM> of the trigger <NUM> when in the first position <NUM>. As shown in <FIG>, the drive initiator <NUM> is disposed a second distance <NUM> from the first end <NUM> of the base <NUM> of the trigger <NUM> when in the second position <NUM>. The second distance <NUM> is greater than the first distance <NUM>.

The drive member <NUM> is moveably attached the drive initiator <NUM> and is moveable relative to the trigger <NUM> and the flip drive <NUM> between a first position <NUM>, as shown in <FIG>, <FIG>, and <FIG>, and a second position <NUM>, as shown in <FIG>, <FIG>. In the first position <NUM>, and when the drive initiator <NUM> is in the first position <NUM>, a portion of the drive member <NUM> is disposed between a first set of guide pegs <NUM> of the retaining cap <NUM>, as described in more detail herein. In the second position <NUM>, and when the drive initiator <NUM> is in the first position <NUM>, the portion of the drive member <NUM> is disposed between a second set of guide pegs <NUM> of the retaining cap <NUM>, as described herein. In the illustrated embodiment, the drive member <NUM> has a lengthwise axis <NUM>, a nose <NUM>, and a tail <NUM>. The nose <NUM> has a first surface <NUM>, a second surface <NUM>, and defines a passageway <NUM> within which the post <NUM> of the drive initiator <NUM> is disposed. The drive member <NUM> is moveable on the post <NUM> between the first and second positions. The lengthwise axis <NUM> extends through the tail <NUM> and the passageway <NUM>. As shown in <FIG>, the first surface <NUM> is disposed at a first angle <NUM> relative to the lengthwise axis <NUM> of the drive member <NUM>. The second surface <NUM> is disposed at a second angle <NUM> relative to the lengthwise axis <NUM> of the drive member <NUM>. Each of the first and second surfaces <NUM>, <NUM> is adapted to contact a portion of the flip drive <NUM> to move the flip drive <NUM> between its first drive position <NUM> and its second drive position <NUM>, as described in more detail herein. The tail <NUM> extends from the nose <NUM> and has a tapered end <NUM> and a length <NUM>, as shown in <FIG> that extends from the tapered end <NUM> to the nose <NUM>. The length <NUM> of the tail <NUM> is less than the distance between the first guide peg <NUM> of the retaining cap <NUM> and the second end <NUM> of the slot <NUM> of the trigger <NUM>.

The flip drive <NUM> is moveably attached to the trigger <NUM> and is moveable between a neutral position <NUM>, a first drive position <NUM>, and a second drive position <NUM>. The flip drive <NUM> is in the neutral position when the trigger <NUM> is in the first position <NUM> and the drive initiator <NUM> is in the first position <NUM>. The flip drive <NUM> is in the first drive position <NUM> when the drive initiator <NUM> is in the second position <NUM> and the drive member <NUM> is in the second position <NUM>. The flip drive <NUM> is in the second drive position <NUM> when the drive initiator <NUM> is in the second position <NUM> and the drive member <NUM> is in the first position <NUM>. The flip drive <NUM> has a lengthwise axis <NUM>, a central portion <NUM>, a projection <NUM>, a first driver arm <NUM>, and a second driver arm <NUM>. The central portion <NUM> defines a first passageway <NUM>, as shown in <FIG>, through which the projection <NUM> of the retaining cap <NUM> is disposed and a second passageway <NUM> through which a portion of the biasing member <NUM> is disposed. The projection <NUM> extends from the central portion <NUM>, toward the drive member <NUM>, and, depending on the position of the drive member <NUM>, is adapted to contact either the first surface <NUM> or the second surface <NUM> of the drive member <NUM>. Each of the first and second driver arms <NUM>, <NUM> is moveably attached to the central portion <NUM> using a living hinge. The lengthwise axis <NUM> of the flip drive <NUM> is disposed at a first angle <NUM> relative to a plane <NUM> that contains the lengthwise axis <NUM> of the trigger <NUM> and the lengthwise axis <NUM> of the base <NUM> when in the neutral position <NUM>, as shown in <FIG>, is disposed at a second angle <NUM> relative to the plane <NUM> that contains the lengthwise axis <NUM> of the trigger <NUM> and the lengthwise axis <NUM> of the base <NUM> when in the first drive position <NUM>, as shown in <FIG>, and is disposed at a third angle <NUM> relative to the plane <NUM> that contains the lengthwise axis <NUM> of the trigger <NUM> and the lengthwise axis <NUM> of the base <NUM> when in the second drive position <NUM>, as shown in <FIG>. The first angle <NUM> is equal to about <NUM> degrees such that the lengthwise axis <NUM> of the flip drive <NUM> is disposed on the plane <NUM> that contains the lengthwise axis <NUM> of the trigger <NUM> and the lengthwise axis <NUM> of the base <NUM>. The second angle <NUM> is between about <NUM> degrees and about <NUM> degrees. The third angle <NUM> is between about <NUM> degrees and about <NUM> degrees. While particular angles have been described, a first angle, a second angle, and a third angle can be any suitable angle. In the illustrated embodiment, the flip drive <NUM> is formed as a single, continuous piece of material. However, in alternative embodiments, a flip drive can be formed of multiple pieces of material attached to one another.

The biasing member <NUM> is disposed within the chamber <NUM> of the housing <NUM>. The biasing member <NUM> is attached to the trigger <NUM> and the flip drive <NUM> and biases the flip drive <NUM> to the neutral position <NUM> when the drive initiator <NUM> is in the first position <NUM>. In the illustrated embodiment, the biasing member <NUM> is an extension spring <NUM> that has a first end <NUM> attached to the projection <NUM> of the trigger <NUM> and a second end <NUM> that is partially disposed within the second passageway <NUM> of the flip drive <NUM> such that the biasing member <NUM> is attached to the flip drive <NUM>. While an extension spring <NUM> has been illustrated, a biasing member <NUM> can comprise any suitable component capable of biasing a flip drive to its neutral position while allowing the flip drive to move between the neutral position, the first drive position, and the second drive position, as described herein.

The retaining cap <NUM> is attached to the trigger <NUM> and has a main body <NUM>, a projection <NUM>, a plurality of guide pegs <NUM>, a first drive belt track <NUM>, and a second drive belt track <NUM>. The projection <NUM> extends from the main body <NUM> toward the trigger <NUM>, through the first passageway <NUM> of the central portion <NUM> of the flip drive <NUM>, and into the first recess <NUM> of the trigger <NUM>. Each peg of the plurality of guide pegs <NUM> extends from the main body <NUM> and toward the trigger <NUM>. The plurality of guide pegs <NUM> includes a first guide peg <NUM>, a second guide peg <NUM>, and a third guide peg <NUM>. As shown in <FIG>, the first guide peg <NUM> has a first length <NUM> and each of the second and third guide pegs <NUM>, <NUM> has a second length <NUM> that is less than the first length <NUM>. The first guide peg <NUM> is disposed within the second recess <NUM> of the trigger <NUM>. The first and second drive belt tracks <NUM>, <NUM> provide a mechanism for maintaining the position of the drive belt <NUM> during use. The drive member <NUM> (e.g., tail <NUM>) is partially disposed between a first set of guide pegs <NUM> of the plurality of guide pegs <NUM> when the drive member <NUM> is in the first position <NUM>. The drive member <NUM> (e.g., tail <NUM>) is partially disposed between a second set of guide pegs <NUM> of the plurality of guide pegs <NUM> when the drive member <NUM> is in the second position <NUM>. The first set of guide pegs <NUM> includes the first guide peg <NUM> and the second guide peg <NUM>. The second set of guide pegs <NUM> includes the first guide peg <NUM> and the third guide peg <NUM>. Thus, the second set of guide pegs <NUM> is different than the first set of guide pegs <NUM>. Alternative embodiments can omit the inclusion of a retaining cap and include a projection, a plurality of guide pegs, a first drive belt track, and/or a second drive belt track on a trigger.

In use, the drive assembly <NUM> moves relative to the housing <NUM> when the flip drive <NUM> is in the first drive position <NUM> and the trigger <NUM> is moved from its first position <NUM> to its second position <NUM>. The drive assembly <NUM> moves relative to the housing <NUM> when the flip drive <NUM> is in the second drive position <NUM> and the trigger <NUM> is moved from its first position <NUM> to its second position <NUM>. The drive assembly <NUM> moves relative to the housing <NUM> in the first direction <NUM> when the flip drive <NUM> is in the first drive position <NUM> and the trigger <NUM> is moved from its first position <NUM> to its second position <NUM>. The drive assembly <NUM> moves relative to the housing <NUM> in the second direction <NUM> when the flip drive <NUM> is in the second drive position <NUM> and the trigger <NUM> is moved from its first position <NUM> to its second position <NUM>.

<FIG> illustrate the example medical device <NUM> during use. <FIG> illustrates the trigger <NUM> in the first position <NUM>, the drive initiator <NUM> in the first position <NUM>, the drive member <NUM> in the first position <NUM>, the flip drive <NUM> in the neutral position <NUM>, and the drive assembly <NUM> static relative to the housing <NUM>. Upon the application of a force on the drive initiator <NUM> directed toward the grip <NUM> while maintaining the position of the housing <NUM>, the drive initiator <NUM> moves from its first position <NUM> toward its second position <NUM>, the drive member <NUM> advances toward the flip drive <NUM>, and the drive member <NUM> contacts the flip drive <NUM> and positions the flip drive <NUM> between the neutral position <NUM> and the first drive position <NUM>. In the illustrated embodiment, the second surface <NUM> of the drive member <NUM> contacts the projection <NUM> of the flip drive <NUM>. <FIG> illustrates the trigger <NUM> in the first position <NUM>, the drive initiator <NUM> between the first position <NUM> and the second position <NUM>, the drive member <NUM> in the first position <NUM>, the flip drive <NUM> between the neutral position <NUM> and the first drive position <NUM>, and the drive assembly <NUM> static relative to the housing <NUM>.

By continuing the application of a force on the drive initiator <NUM> directed toward the grip <NUM> while maintaining the position of the housing <NUM>, the drive initiator <NUM> continues to advance toward its second position <NUM>, the drive member <NUM> advances toward the flip drive <NUM>, and the drive member <NUM> contacts the flip drive <NUM> and positions the flip drive <NUM> between the neutral position <NUM> and the first drive position <NUM>. In the illustrated embodiment, the second surface <NUM> of the drive member <NUM> contacts the projection <NUM> of the flip drive <NUM>, the drive member <NUM> contacts the first driver arm <NUM> of the flip drive <NUM>, and the first driver arm <NUM> of the flip drive <NUM> contacts the drive belt <NUM> of the drive assembly <NUM>. <FIG> illustrates the trigger <NUM> in the first position <NUM>, the drive initiator <NUM> between the first position <NUM> and the second position <NUM>, the drive member <NUM> between the first position <NUM> and the second position <NUM>, the flip drive <NUM> between the neutral position <NUM> and the first drive position <NUM> and contacting the drive assembly <NUM> (e.g., drive belt <NUM>), and the drive assembly <NUM> static relative to the housing <NUM>.

By continuing the application of a force on the drive initiator <NUM> directed toward the grip <NUM> and applying a force on the trigger <NUM> directed toward the grip <NUM> while maintaining the position of the housing <NUM>, the drive initiator <NUM> advances to its second position <NUM>, the drive member <NUM> advances toward the flip drive <NUM>, and the drive member <NUM> contacts the flip drive <NUM> and positions the flip drive <NUM> in the first drive position <NUM>. In the illustrated embodiment, the second surface <NUM> of the drive member <NUM> contacts the projection <NUM> of the flip drive <NUM>, the first surface <NUM> of the drive member <NUM> contacts the first driver arm <NUM> of the flip drive <NUM>, and the first driver arm <NUM> of the flip drive <NUM> contacts the drive belt <NUM> of the drive assembly <NUM>. The structural configuration of the flip drive <NUM> provides a mechanism for moving the drive member <NUM> between its first and second positions during use. <FIG> illustrates the trigger <NUM> between the first position <NUM> and the second position <NUM>, the drive initiator <NUM> in the second position <NUM>, the drive member <NUM> in the second position <NUM>, the flip drive <NUM> in the first drive position <NUM> and contacting the drive assembly <NUM> (e.g., drive belt <NUM>), and the drive assembly <NUM> moving relative to the housing <NUM> in a first direction <NUM>.

The drive assembly <NUM> continues to move relative to the housing <NUM> in the first direction <NUM> as the trigger <NUM> is advanced to its second position <NUM>. By releasing the application of a force on the drive initiator <NUM> and the trigger <NUM>, the trigger <NUM> advances toward the first position <NUM> due to the bias of the coil member <NUM>, the drive initiator <NUM> advances toward its first position <NUM>, the drive member <NUM> advances away from the flip drive <NUM>, and the drive member <NUM> positions the flip drive <NUM> between the neutral position <NUM> and the first drive position <NUM>. In the illustrated embodiment, the second surface <NUM> of the drive member <NUM> contacts the projection <NUM> of the flip drive <NUM>. <FIG> illustrates the trigger <NUM> between the first position <NUM> and the second position <NUM>, the drive initiator <NUM> between the first position <NUM> and the second position <NUM>, the drive member <NUM> in the second position <NUM>, the flip drive <NUM> between the neutral position <NUM> and the first drive position <NUM>, and the drive assembly <NUM> static relative to the housing <NUM>. If it is desired to continue to move the drive assembly <NUM> relative to the housing in the first direction <NUM>, a user can re-apply a force on the drive initiator <NUM> and a force on the trigger <NUM> directed toward the grip <NUM> while maintaining the position of the housing <NUM>, as described above, and prior to the trigger <NUM> arriving at its first position <NUM> and the drive initiator <NUM> arriving at its first position <NUM>. This results in use of the drive assembly <NUM> in a uni-directional manner. The application and removal of a force can be repeated any suitable number of times to achieve movement of the drive assembly <NUM> in the first direction <NUM>.

<FIG> illustrates the trigger <NUM> in the first position <NUM>, the drive initiator <NUM> in the first position <NUM>, the drive member <NUM> in the second position <NUM>, the flip drive <NUM> in the neutral position <NUM>, and the drive assembly <NUM> static relative to the housing <NUM>.

Upon the application of a force on the drive initiator <NUM> directed toward the grip <NUM> while maintaining the position of the housing <NUM>, the drive initiator <NUM> advances toward its second position <NUM>, the drive member <NUM> advances toward the flip drive <NUM>, and the drive member <NUM> contacts the flip drive <NUM> and positions the flip drive <NUM> between the neutral position <NUM> and the second drive position <NUM>. In the illustrated embodiment, the first surface <NUM> of the drive member <NUM> contacts the projection <NUM> of the flip drive <NUM>, the drive member <NUM> contacts the second driver arm <NUM> of the flip drive <NUM>, and the second driver arm <NUM> of the flip drive <NUM> contacts the drive belt <NUM> of the drive assembly <NUM>. <FIG> illustrates the trigger <NUM> in the first position <NUM>, the drive initiator <NUM> between the first position <NUM> and the second position <NUM>, the drive member <NUM> between the first position <NUM> and the second position <NUM>, the flip drive <NUM> between the neutral position <NUM> and the second drive position <NUM> and contacting the drive assembly <NUM> (e.g., drive belt <NUM>), and the drive assembly <NUM> static relative to the housing <NUM>.

By continuing the application of a force on the drive initiator <NUM> directed toward the grip <NUM> and applying a force on the trigger <NUM> directed toward the grip <NUM> while maintaining the position of the housing <NUM>, the drive initiator <NUM> advances to its second position <NUM>, the drive member <NUM> advances toward the flip drive <NUM>, and the drive member <NUM> contacts the flip drive <NUM> and positions the flip drive <NUM> in the second drive position <NUM>. In the illustrated embodiment, the first surface <NUM> of the drive member <NUM> contacts the projection <NUM> of the flip drive <NUM>, the second surface <NUM> of the drive member <NUM> contacts the second driver arm <NUM> of the flip drive <NUM>, and the second driver arm <NUM> of the flip drive <NUM> contacts the drive belt <NUM> of the drive assembly <NUM>. The structural configuration of the flip drive <NUM> provides a mechanism for moving the drive member <NUM> between its second and first positions during use. <FIG> illustrates the trigger <NUM> between the first position <NUM> and the second position <NUM>, the drive initiator <NUM> in the second position <NUM>, the drive member <NUM> in the first position <NUM>, the flip drive <NUM> in the second drive position <NUM> and contacting the drive assembly <NUM> (e.g., drive belt <NUM>), and the drive assembly <NUM> moving relative to the housing <NUM> in a second direction <NUM>.

The drive assembly <NUM> continues to move relative to the housing <NUM> in the second direction <NUM> as the trigger <NUM> is advanced to its second position <NUM>. By releasing the application of a force on the drive initiator <NUM> and the trigger <NUM>, the trigger <NUM> advances toward the first position <NUM> due to the bias of the coil member <NUM>, the drive initiator <NUM> advances toward its first position <NUM>, the drive member <NUM> advances away from the flip drive <NUM>, and the drive member <NUM> positions the flip drive <NUM> between the neutral position <NUM> and the second drive position <NUM>. In the illustrated embodiment, the first surface <NUM> of the drive member <NUM> contacts the projection <NUM> of the flip drive <NUM>. <FIG> illustrates the trigger <NUM> between the first position <NUM> and the second position <NUM>, the drive initiator <NUM> between the first position <NUM> and the second position <NUM>, the drive member <NUM> in the first position <NUM>, the flip drive <NUM> between the neutral position <NUM> and the second drive position <NUM>, and the drive assembly <NUM> static relative to the housing <NUM>. If it is desired to continue to move the drive assembly <NUM> relative to the housing in the second direction <NUM>, a user can re-apply a force on the drive initiator <NUM> and a force on the trigger <NUM> directed toward the grip <NUM> while maintaining the position of the housing <NUM>, as described above, and prior to the trigger <NUM> arriving at its first position <NUM> and the drive initiator <NUM> arriving at its first position <NUM>. This results in use of the drive assembly <NUM> in a uni-directional manner. The application and removal of a force can be repeated any suitable number of times to achieve movement of the drive assembly <NUM> in the first direction <NUM>.

<FIG> illustrates another example flip drive <NUM>' that can be included in a medical device. The flip drive <NUM>' is similar to the flip drive <NUM> illustrated in <FIG> and described above, except as detailed below.

In the illustrated embodiment, the flip drive <NUM>' has a lengthwise axis <NUM>', a central portion <NUM>', a projection <NUM>', a first driver arm <NUM>', and a second driver arm <NUM>'. The central portion <NUM>' defines a first passageway <NUM>' through which a projection of a retaining cap can be disposed and a hook <NUM>' to which a portion of a biasing member can be attached. The projection <NUM>' extends from the central portion <NUM>' and each of the first and second driver arms <NUM>', <NUM>' is moveably attached to the central portion <NUM>' using a living hinge. In the embodiment shown, the first driver arm <NUM>' includes a first projection <NUM>' and the second driver arm <NUM>' includes a second projection <NUM>'. The first projection <NUM>' extends from the end <NUM>' of the first driver arm <NUM>' and towards the central portion <NUM>' and the second projection <NUM>' extends from the end <NUM>' of the second driver arm <NUM>' and towards the central portion <NUM>'.

<FIG> illustrates another example trigger assembly <NUM> that can be included in a medical device. The trigger assembly <NUM> is similar to the trigger assembly <NUM> illustrated in <FIG> and described above, except as detailed below. In the illustrated embodiment, the trigger assembly <NUM> includes a trigger <NUM>, a drive initiator <NUM>, a drive member <NUM>, a flip drive <NUM>, a biasing member <NUM>, and a retaining cap <NUM>.

In the illustrated embodiment, the drive member <NUM> is moveably attached to the drive initiator <NUM> and is moveable relative to the trigger <NUM> and the flip drive <NUM> between first and second positions.

The flip drive <NUM> is moveably attached to the trigger <NUM> and is moveable between a neutral position, a first drive position, and a second drive position. <FIG> illustrates the flip drive in the neutral position. The flip drive <NUM> has a central portion <NUM>, a projection <NUM>, a first driver arm <NUM>, and a second driver arm <NUM>. The central portion <NUM> defines a first passageway <NUM> through which a portion of the retaining cap <NUM> is disposed and a second passageway <NUM> within which a first magnet <NUM> of the biasing member <NUM> is disposed. The projection <NUM> extends from the central portion <NUM>, toward the drive member <NUM>, and is adapted to contact the drive member <NUM>.

The biasing member <NUM> is attached to the trigger <NUM> and the flip drive <NUM> as biases the flip drive <NUM> to the neutral position <NUM>. In the illustrated embodiment, the biasing member <NUM> includes a first magnet <NUM> and a second magnet <NUM>. The first magnet <NUM> is disposed within the second passageway <NUM> defined by the flip drive <NUM> and is attached to the flip drive <NUM>. The second magnet <NUM> is attached to the projection <NUM> of the trigger <NUM>.

<FIG> illustrates another example trigger assembly <NUM> that can be included in a medical device. The trigger assembly <NUM> is similar to the trigger assembly <NUM> illustrated in <FIG> and described above, except as detailed below. In the illustrated embodiment, the trigger assembly <NUM> includes a trigger <NUM>, a drive initiator <NUM>, a drive member <NUM>, a flip drive <NUM>, and a biasing member <NUM>.

In the illustrated embodiment, the trigger assembly <NUM> includes a single guide peg <NUM> that is disposed on the trigger <NUM>, which provides a mechanism to move the drive member <NUM> between its first and second positions, as described herein. In addition, in the embodiment illustrated, the biasing member <NUM> is attached to the trigger <NUM> and the flip drive <NUM> as biases the flip drive <NUM> to the neutral position <NUM> when the drive initiator <NUM> is in the first position <NUM>. In the illustrated embodiment, the biasing member <NUM> is an elongate member <NUM> that has a first end <NUM> attached to the projection <NUM> of the trigger <NUM> and a second end <NUM> that is attached to the flip drive <NUM>. The biasing member <NUM> can include any suitable structural arrangement (e.g., weakened portions, portions with a reduced thickness) to accomplish biasing the flip drive <NUM> to its neutral position <NUM> while allowing the flip drive <NUM> to move between the neutral position <NUM>, the first drive position, and the second drive position, as described herein.

While the medical devices that include a trigger assembly for a rotatable catheter, and their associated components, have been illustrated herein as having particular structural arrangements, other structural arrangements are considered suitable and a medical device that includes a trigger assembly for a rotatable catheter, and any associated component, can be formed of any suitable material and using any suitable technique or method of manufacture. Selection of a suitable structural arrangement, material, and/or suitable technique or method of manufacture can be based on various considerations, including the intended use of the medical device that includes a trigger assembly for a rotatable catheter. Examples of materials considered suitable to form a medical device that includes a trigger assembly for a rotatable catheter, and/or any component of a medical device that includes a trigger assembly for a rotatable catheter, include biocompatible materials, materials that can be made biocompatible, braided materials, coiled materials, metals, such as <NUM> stainless and <NUM> stainless, Nitinol, corrosion resistant materials, plastics, polymers, polyethylene, such as high-density polyethylene (HDPE), polypropylene, polycarbonates, silicone, Delrin, transparent materials, opaque materials, combinations of the materials described herein, layered materials, and any other material considered suitable for a particular embodiment.

The trigger assemblies described herein are considered advantageous relative to previous trigger assemblies at least because the position of a drive member (e.g., drive member <NUM>) can be maintained prior to engagement with a flip drive (e.g., flip drive <NUM>) through use of one or more guide pegs, as described herein. In addition, the structural arrangement and fit between a drive member and a flip drive: <NUM>) increases the surface area of a drive member that contacts a flip drive during use; <NUM>) allows a user to maintain the directionality of the drive assembly when a trigger is moved to its second position and it is prevented from returning to its first position; and <NUM>) provides an efficient transition of the drive member between its first and second positions during use. Furthermore, the position of a tail of a drive member relative to one or more guide pegs can be alternated and maintained every time a trigger is advanced to its second position. Each of these advantages increases the efficiency of the movement of the drive assembly between its first and second directions, reducing the time required to complete a procedure and the hand fatigue experienced by a user during use of the medical device.

Various methods of using a medical device that includes a trigger assembly for a rotatable catheter are described herein. While the methods described herein are shown and described as a series of acts, it is to be understood and appreciated that the methods are not limited by the order of acts, as some acts may in accordance with these methods, occur in the order shown and/or described, in different orders, and/or concurrently with other acts described herein.

<FIG> is a schematic illustration of an example method <NUM> of using a first medical device that includes a trigger assembly for a rotatable catheter. Method <NUM> can be used to remove a second medical device attached to a portion of a body of an animal, such as a human. The second medical device can be disposed within a bodily passage of the body of the animal.

A step <NUM> comprises obtaining a first medical device that includes a trigger assembly for a rotatable catheter that has a housing, a catheter, a drive assembly, and a trigger assembly. The trigger assembly includes a trigger, a drive initiator, a drive member, a flip drive, a biasing member, and a retaining cap. The drive member is in the first position. Another step <NUM> comprises introducing a portion of a second medical device disposed within a bodily passage of a body of an animal into a lumen defined by the catheter. Another step <NUM> comprises applying a proximally-directed force on the second medical device while maintaining the position of the first medical device until the second medical device is disposed proximal to the catheter. Another step <NUM> comprises applying a distally-directed force on the first medical device while applying proximally-directed force on the second medical device such that the first medical device is introduced into the bodily passage (e.g., vessel). Another step <NUM> comprises continuing the application of a distally-directed force on the first medical device while applying proximally-directed force on the second medical device such that the first medical device is advanced into the bodily passage. Another step <NUM> comprises applying a proximally-directed force on the drive initiator and the trigger while maintaining the position of the grip such that the drive member moves to the second position, the flip drive contacts a portion of the drive assembly, and the catheter rotates and dissects tissue (e.g., encapsulated tissue) from the second medical device. Another step <NUM> comprises stopping the application of a proximally-directed force on the drive initiator and trigger. Another step <NUM> comprises applying a distally-directed force on the first medical device while applying a proximally-directed force on the second medical device such that the first medical device is advanced into the bodily passage. Another step <NUM> comprises applying a proximally-directed force on the second medical device while maintaining the position of the first medical device until the second medical device is withdrawn from the bodily passage. Another step <NUM> comprises applying a proximally-directed force on the first medical device until the first medical device (e.g., catheter) is withdrawn from the bodily passage.

Optional steps that can be completed prior to step <NUM> when completing a superior approach (e.g., through the subclavian vein) include: surgically exposing a proximal end of the second medical device; removing the second medical device from any connections; removing any suture and/or tie-down materials attached to, or disposed over, the second medical device; removing any proximal fittings attached to the second medical device; introducing a wire guide into a lumen defined by the second medical device; advancing the wire guide through lumen of the second medical device to confirm patency of the lumen defined by the second medical device; withdrawing the wire guide from the lumen defined by the second medical device; introducing a locking stylet into the lumen defined by the second medical device; advancing the locking stylet to the distal end of the second medical device; locking the locking stylet in place; when the second medical device comprises an active fixation type lead, another optional step comprises applying torque to the second medical device to unscrew the second medical device from tissue (e.g., cardiac tissue).

Step <NUM> can be accomplished using any suitable medical device that includes a trigger assembly for a rotatable catheter, such as those described herein. For example, medical device <NUM> illustrated in <FIG>, a medical device that includes the flip drive <NUM>' illustrated in <FIG>, a medical device that includes the trigger assembly <NUM> illustrated in <FIG>, or a medical device that include the trigger assembly <NUM> illustrated in <FIG> can be used.

Step <NUM> can be accomplished by inserting any suitable portion of any suitable second medical device into a lumen defined by the catheter. A second medical device used to complete method <NUM> has a proximal end, a distal end, and defines a lumen within which multiple components are disposed. For example, a second medical device can comprise a cardiac lead that extends from the proximal end, which can be disposed outside of a bodily passage (e.g., subclavian vein), through the bodily passage (e.g., subclavian vein, superior vena cava, and right cardiac chamber(s)), to the distal end. The distal end of the second medical device is attached to tissue (e.g., cardiac tissue within right atrium, cardiac tissue within right ventricle). While a cardiac lead has been described as an example of a second medical device that can be used to complete method <NUM>, the medical devices that include a trigger assembly for a rotatable catheter described herein can be used on any suitable tubular member and/or second medical device disposed within a body.

In an alternative embodiment, step <NUM> can be omitted and step <NUM> can comprise introducing a portion of a second medical device disposed within a bodily passage of a body of an animal into a lumen defined by a catheter of a first medical device. The first medical device includes a trigger assembly for a rotatable catheter that has a housing, the catheter, a drive assembly, and a trigger assembly. The trigger assembly includes a trigger, a drive initiator, a drive member, a flip drive, a biasing member, and a retaining cap. The drive member is in the first position.

Step <NUM> can alternatively comprise applying a proximally-directed force on the second medical device while applying a distally-directed force on the first medical device until the second medical device is disposed proximal to the catheter or comprise applying a distally-directed force on the first medical device while maintaining the position of the second medical device until the second medical device is disposed proximal to the catheter.

Step <NUM> can be accomplished by introducing the first medical device into any suitable bodily passage and such that the first medical device is tracked over the second medical device, which is disposed within the lumen defined by the catheter, and the catheter is introduced into the bodily passage. Examples of bodily passages within which it is considered suitable to introduce a first medical device, such as those described herein, include veins, such as the subclavian vein, arteries, and any other bodily passage considered suitable for a particular embodiment.

Step <NUM> can be accomplished by advancing the first medical device over the second medical device and into any suitable bodily passage such that the catheter is advanced into the bodily passage. Examples of bodily passages within which it is considered suitable to advance a first medical device, such as those described herein, include the veins, such as the subclavian vein, the superior vena cava, arteries, the right atrium, the right ventricle, and any other bodily passage considered suitable for a particular embodiment.

Step <NUM> can be accomplished in instances in which the first medical device encounters tissue encapsulation (e.g., calcification, fibrous tissue) while being tracked over the second medical device. Alternatively, in embodiments in which tissue encapsulation is not encountered, step <NUM> and step <NUM> can be omitted from method <NUM>. An optional step that can be completed concurrently with step <NUM> comprises applying a proximally-directed force on the first medical device or a distally-directed force on the first medical device. Optionally, step <NUM> can be repeated any suitable number of times, such as when any additional tissue encapsulation and/or calcification is encountered. If repeated, the application of a proximally-directed force on the drive initiator and the trigger while maintaining the position of the grip results in the drive member moving between its first and second positions, contact between the flip drive and a portion of the drive assembly, and rotation of the catheter such that it dissects tissue (e.g., encapsulated tissue) from the second medical device.

Step <NUM> can be accomplished as described above with respect to step <NUM>.

Any of the steps described in method <NUM> can be accomplished while visualizing the first medical device, the second medical device, the bodily passage, and/or tissue using any suitable technique or method of visualization. For example, any of the steps described in method <NUM> can be accomplished under fluoroscopic monitoring. The methods described herein may comprise methods which are not methods of treatment of the human or animal body by surgery or therapy. For example such methods may be carried out on non-living models of the human or animal anatomy such as dummies and cadavers.

As described herein, the present disclosure provides medical devices that include a trigger assembly for a rotatable catheter (and methods of use have also been described herein). Aspects of the present disclosure provide a medical device that includes a housing, a catheter, a drive assembly, and a trigger assembly. The trigger assembly is partially disposed within the housing and includes a trigger, a drive initiator, a drive member, a flip drive, and a biasing member. The trigger is moveable between a first position and a second position relative to the housing. The flip drive is moveable between a neutral position, a first drive position, and a second drive position. The drive assembly moves relative to the housing when the flip drive is in the first drive position and the trigger is moved from its first position to its second position.

Claim 1:
A medical device (<NUM>) comprising:
a housing (<NUM>) defining a chamber (<NUM>) and a passageway (<NUM>) in communication with the chamber;
a catheter (<NUM>) partially disposed through the passageway and rotatable relative to the housing;
a drive assembly (<NUM>) disposed within the chamber and moveable relative to the housing, movement of the drive assembly resulting in rotation of the catheter; and
a trigger assembly (<NUM>) partially disposed within the chamber, the trigger assembly comprising:
a trigger (<NUM>) attached to the housing and moveable between a first position and a second position relative to the housing;
characterised by:
a drive initiator (<NUM>) attached to the trigger and moveable between a first position and a second position relative to the trigger;
a drive member (<NUM>) attached the drive initiator and moveable relative to the trigger between a first position and a second position;
a flip drive (<NUM>) attached to the trigger (<NUM>) and moveable between a neutral position, a first drive position, and a second drive position, the flip drive in the neutral position when the drive initiator is in the first position, the flip drive in the first drive position when the drive initiator is in the second position and the drive member is in the second position, the flip drive in the second drive position when the drive initiator is in the second position and the drive member is in the first position; and
a biasing member (<NUM>) disposed within the chamber and biasing the flip drive to the neutral position when the drive initiator is in the first position;
wherein the drive assembly moves relative to the housing when the flip drive is in the first drive position and the trigger is moved from its first position to its second position; and
wherein the drive assembly moves relative to the housing when the flip drive is in the second drive position and the trigger is moved from its first position to its second position.