CATHETER HANDLE WITH A LOCKING MECHANISM

A system (100) includes a handle (130), a sheath (122) attached to and distally extending from the handle (130), and a tubular component (102) slidingly disposed within the sheath (122). The handle (130) includes a locking mechanism (140) including an unlocked state in which the tubular component (102) is permitted to slide and rotate freely relative to the sheath (122), a locked state in which the tubular component (102) is not permitted to slide or rotate relative to the sheath (122), a first semi-locked state in which the tubular component (102) is permitted to slide freely relative to the sheath (122) and is not permitted to rotate freely in a circumferential direction relative to the sheath (122), and a second semi-locked state in which the tubular component (102) is not permitted to slide freely in a longitudinal direction relative to the sheath (122) and is permitted to rotate freely in a circumferential direction relative to the sheath (122).

FIELD

Embodiments hereof relate to catheters and more particularly to a delivery system having a torqueable catheter shaft.

BACKGROUND

A variety of catheters for delivering a therapy and/or monitoring a physiological condition have been implanted or proposed for implantation in patients. Catheters may deliver therapy to, and/or monitor conditions associated with, the heart, muscle, nerve, brain, stomach or other organs or tissue. Many catheters are tracked through the vasculature to locate a therapeutic or diagnostic portion of the catheter at a target site. Such catheters must have flexibility to navigate the twists and turns of the vasculature, sufficient stiffness in the proximal portion thereof to be pushed through the vasculature alone or over a guidewire or through a lumen, and the capability of orienting a distal portion thereof in alignment with an anatomical feature at the target site so that a diagnostic or therapeutic procedure can be completed. In general terms, the catheter body must also resist kinking and be capable of being advanced through access pathways that twist and turn, sometimes abruptly at acute angles.

For certain procedures, it may be necessary for the clinician to accurately steer or deflect the catheter so that a distal opening thereof may be aligned with an ostium of a branch or side vessel. The distal portions of catheters frequently need to be selectively curved or bent and straightened again while being advanced within the patient to steer the catheter distal end into a desired body lumen or chamber. For example, it may be necessary to direct the catheter distal end through tortuous anatomies and/or into a branch at a vessel bifurcation. In addition, some procedures require high accuracy in guidewire orientation. For example, often patient's arteries are irregularly shaped, highly tortuous and very narrow. The tortuous configuration of the arteries may present difficulties to a clinician in advancement of a catheter to a treatment site.

In addition to bending or deflecting the distal portion of the catheter during navigation, the clinician may also need to rotate or torque the catheter when advancing the catheter to a treatment site in order to achieve proper or desired alignment of the catheter. However, manually torqueing the delivery system may require significant force to combat recoiling forces.

Thus, a need in the art still generally exists for improved apparatuses and methods for navigating a catheter through or within a patient's anatomy.

BRIEF SUMMARY

According to a first embodiment hereof, the present disclosure provides a system which includes a handle, a sheath attached to and distally extending from the handle, and a tubular component slidingly disposed within the sheath. The handle includes a locking mechanism including an unlocked state in which the tubular component is permitted to slide freely in a longitudinal direction relative to the sheath and is permitted to rotate freely in a circumferential direction relative to the sheath, a locked state in which the tubular component is not permitted to slide freely in the longitudinal direction relative to the sheath and is not permitted to rotate freely in the circumferential direction relative to the sheath, a first semi-locked state in which the tubular component is permitted to slide freely in a longitudinal direction relative to the sheath and is not permitted to rotate freely in a circumferential direction relative to the sheath, and a second semi-locked state in which the tubular component is not permitted to slide freely in a longitudinal direction relative to the sheath and is permitted to rotate freely in a circumferential direction relative to the sheath.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the tubular component forms an outer tubular component of a balloon catheter.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the locking mechanism includes a collet, a locking collar, and a locking bearing, each of the locking collar and the locking bearing being slidingly disposed over the collet.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides a locking interface on an outer surface of the tubular component. The locking interface has an outer surface including a plurality of grooves and a plurality of ridges, each groove formed between a pair of adjacent ridges. The collet is disposed over the locking interface and the collet has an inner surface with a sinusoidal configuration including a plurality of peaks and a plurality of valleys, each valley formed between a pair of adjacent peaks. Each groove of the locking interface is configured to receive a pair of adjacent peaks of the collet.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that each of the locking collar and the locking bearing is configured to be axially translated by the user between at least a non-engaged position on the collet and an engaged position on the collet.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that each of the locking collar and the locking bearing is disposed in the non-engaged position on the collet when the locking mechanism is in the unlocked state.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that each of the locking collar and the locking bearing is disposed in the engaged position on the collet when the locking mechanism is in the locked state.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the locking collar is disposed in the engaged position and the locking bearing is disposed in the non-engaged position on the collet when the locking mechanism is in the first semi-locked state.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the locking collar is disposed in the non-engaged position on the collet and the locking bearing is disposed in the engaged position on the collet when the locking mechanism is in the second semi-locked state.

In an aspect of the first embodiment, and in combination with any other aspects herein, the disclosure provides that the handle further includes an indexing component configured to output a tactile click at one or more defined degrees of rotation of the treatment catheter.

According to a second embodiment hereof, the present disclosure provides a system which includes a treatment catheter and a guide catheter including a sheath configured to receive the treatment catheter and a handle coupled to the sheath. The handle includes a locking mechanism having an unlocked state in which the treatment catheter is permitted to slide freely in a longitudinal direction relative to the sheath and is permitted to rotate freely in a circumferential direction relative to the sheath, a locked state in which the treatment catheter is not permitted to slide freely in the longitudinal direction relative to the sheath and is not permitted to rotate freely in the circumferential direction relative to the sheath, a first semi-locked state in which the treatment catheter is permitted to slide freely in a longitudinal direction relative to the sheath and is not permitted to rotate freely in a circumferential direction relative to the sheath, and a second semi-locked state in which the treatment catheter is not permitted to slide freely in a longitudinal direction relative to the sheath and is permitted to rotate freely in a circumferential direction relative to the sheath.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that an outer surface of the treatment catheter includes a locking interface disposed thereon. The locking interface has an outer surface including a plurality of grooves and a plurality of ridges, each groove formed between a pair of adjacent ridges. The locking mechanism is disposed over the locking interface and has an inner surface with a sinusoidal configuration including a plurality of peaks and a plurality of valleys, each valley formed between a pair of adjacent peaks. Each groove of the locking interface is configured to receive a pair of adjacent peaks of the locking mechanism.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the locking mechanism includes a collet, a locking collar, and a locking bearing, each of the locking collar and the locking bearing being slidingly disposed over the collet.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the collet includes the inner surface including the plurality of peaks and the plurality of valleys.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that each of the locking collar and the locking bearing is configured to be axially translated by the user between at least a non-engaged position on the collet and an engaged position on the collet.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the each of the locking collar and the locking bearing is disposed in the non-engaged position on the collet when the locking mechanism is in the unlocked state.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that each of the locking collar and the locking bearing is disposed in the engaged position on the collet when the locking mechanism is in the locked state.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the locking collar is disposed in the engaged position and the locking bearing is disposed in the non-engaged position on the collet when the locking mechanism is in the first semi-locked state.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the locking collar is disposed in the non-engaged position on the collet and the locking bearing is disposed in the engaged position on the collet when the locking mechanism is in the second semi-locked state.

In an aspect of the second embodiment, and in combination with any other aspects herein, the disclosure provides that the handle further includes an indexing component configured to output a tactile click at one or more defined degrees of rotation of the treatment catheter.

According to a third embodiment hereof, the present disclosure provides a system including a catheter and a locking mechanism. An outer surface of the catheter includes a locking interface having an outer surface including a plurality of grooves and a plurality of ridges, each groove formed between a pair of adjacent ridges. The locking mechanism is disposed over the locking interface. The locking mechanism includes a collet, a locking collar, and a locking bearing. Each of the locking collar and the locking bearing is slidingly disposed over the collet. The collet has an inner surface with a sinusoidal configuration including a plurality of peaks and a plurality of valleys, each valley formed between a pair of adjacent peaks. Each groove of the locking interface is configured to receive a pair of adjacent peaks of the collet. At least one of the locking collar and the locking bearing is configured to be axially translated by the user between at least a non-engaged position on the collet and an engaged position on the collet.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the catheter is a balloon catheter.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that each of the locking collar and the locking bearing is configured to be axially translated by the user between at least a non-engaged position on the collet and an engaged position on the collet.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that only the locking collar is configured to be axially translated by the user between at least a non-engaged position on the collet and an engaged position on the collet.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the locking bearing is disposed on the collet in an engaged position.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that only the locking bearing is configured to be axially translated by the user between at least a non-engaged position on the collet and an engaged position on the collet.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the locking collar is disposed on the collet in an engaged position.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the locking collar is disposed on the collet in a non-engaged position.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the locking mechanism is disposed within a handle of a guide catheter and a sheath of the guide catheter is configured to slidingly receive the catheter.

In an aspect of the third embodiment, and in combination with any other aspects herein, the disclosure provides that the handle further includes an indexing component configured to output a tactile click at one or more defined degrees of rotation of the catheter.

According to a fourth embodiment hereof, the present disclosure provides a catheter configured for passing through vasculature to a target site. The catheter includes a proximal end portion and a distal end portion. The distal end portion includes a medical component and the proximal end portion has an outer surface. The outer surface has a plurality of grooves and at least one raised portion.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface forms an interface for coupling to a control apparatus.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface has a plurality of longitudinally extending grooves and the raised portion includes a longitudinally extending ridge extending between adjacent grooves.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface has a plurality of longitudinally extending grooves and a plurality of said raised portions. Each raised portion includes a longitudinally extending ridge extending between adjacent grooves.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface is integrally formed with the catheter.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the catheter includes a first tubular member and a second member that forms the outer surface. The first and second members are fixedly secured to one another.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the catheter is a treatment catheter and the medical component is a balloon.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the raised portion is a longitudinally extending ridge.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface includes a plurality of grooves and the raised portion extends longitudinally between adjacent grooves.

In an aspect of the fourth embodiment, and in combination with any other aspects herein, the disclosure provides that the catheter is a diagnostic catheter and the medical component is a sensor.

According to a fifth embodiment hereof, the present disclosure provides a catheter configured for passing through vasculature to a target site. The catheter includes a proximal end portion and a distal end portion. The distal end portion includes a medical component and the proximal end portion has an outer surface. The outer surface has a plurality of ridges and a groove extending between adjacent ridges.

In an aspect of the fifth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface forms an interface for coupling to a control apparatus.

In an aspect of the fifth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface has a plurality of longitudinally extending grooves and a longitudinally extending ridge extending between adjacent grooves.

In an aspect of the fifth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface has a plurality of longitudinally extending grooves and a plurality of longitudinally extending ridges, each longitudinally extending ridge extending between adjacent grooves.

In an aspect of the fifth embodiment, and in combination with any other aspects herein, the disclosure provides that the outer surface is integrally formed with the catheter.

In an aspect of the fifth embodiment, and in combination with any other aspects herein, the disclosure provides that the catheter includes a first tubular member and a second member that forms the outer surface. The first and second members being fixedly secured to one another.

In an aspect of the fifth embodiment, and in combination with any other aspects herein, the disclosure provides that the catheter is a treatment catheter and the medical component is a balloon.

In an aspect of the fifth embodiment, and in combination with any other aspects herein, the disclosure provides that the catheter is a diagnostic catheter and the medical component is a sensor.

DETAILED DESCRIPTION

Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” or “distally” are a position distant from or in a direction away from the clinician. “Proximal” and “proximally” are a position near or in a direction toward the clinician. In addition, “slidably” or “slidable” denotes back and forth movement in a longitudinal direction about a longitudinal axis LA of the system (shown inFIG.1) while “rotatably” or “rotatable” denotes movement or rotation about the longitudinal axis LA.

The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of the invention is in the context of delivery of a balloon-expandable prosthesis, the invention may also be used where it is deemed useful in endoscopic procedures, procedures in the coronary vessels, or procedures in the peripheral vessels. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

Embodiments hereof relate to a handle with a locking mechanism configured to selectively release a tubular component disposed within the handle in order to allow the user to rotate and/or axially translate the tubular component relative to the handle. In an embodiment, the handle is part of a guide catheter that also includes a sheath extending distally from the handle, and the tubular component disposed within the handle is part of a treatment catheter such as but not limited to a balloon catheter or a valve delivery catheter. The locking mechanism of the handle permits a user to selectively rotate and/or axially translate the treatment catheter relative to the sheath and the handle of the guide catheter. The locking mechanism includes an unlocked state or configuration in which the tubular component is permitted to slide freely in a longitudinal direction relative to the handle and is permitted to rotate freely in a circumferential direction relative to the handle, a locked state or configuration in which the tubular component is not permitted to slide freely in the longitudinal direction relative to the handle and is not permitted to rotate freely in the circumferential direction relative to the handle, a first semi-locked state or configuration in which the tubular component is permitted to slide freely in a longitudinal direction relative to the handle and is not permitted to rotate freely in a circumferential direction relative to the handle, and a second semi-locked state or configuration in which the tubular component is not permitted to slide freely in a longitudinal direction relative to the handle and is permitted to rotate freely in a circumferential direction relative to the handle. Stated another way, the locking mechanism of the handle may be considered a toggle switch that enables switching between four different states or configurations: (1) an unlocked state in which the treatment catheter is permitted move freely in both longitudinal and rotational directions relative to the guide catheter, (2) a locked state in which the treatment catheter is locked such that rotational and longitudinal movement relative to the guide catheter is prevented, (3) a first semi-locked state in which longitudinal movement of the treatment catheter relative to the guide catheter is permitted while preventing longitudinal movement thereof, and (4) a second semi-locked state in which rotational movement of the treatment catheter relative to the guide catheter is permitted while preventing longitudinal movement thereof. Controlled longitudinal and rotational movement of the treatment catheter relative to the guide catheter is beneficial for precise positioning of the treatment catheter in situ.

FIGS.1,1A, and2illustrates a system100according to an embodiment hereof. The system100includes a treatment catheter102and a guide catheter120. The guide catheter120includes a sheath122configured to receive the treatment catheter102and a handle130coupled to the sheath122. As will be explained in more detail herein, the handle130includes a locking mechanism140having an unlocked state or configuration in which the treatment catheter102is permitted to slide freely in a longitudinal direction relative to the sheath122and is permitted to rotate freely in a circumferential direction relative to the sheath122, a locked state or configuration in which the treatment catheter102is not permitted to slide freely in the longitudinal direction relative to the sheath122and is not permitted to rotate freely in the circumferential direction relative to the sheath122, a first semi-locked state or configuration in which the treatment catheter102is permitted to slide freely in a longitudinal direction relative to the sheath122and is not permitted to rotate freely in a circumferential direction relative to the sheath, and a second semi-locked state or configuration in which the treatment catheter102is not permitted to slide freely in a longitudinal direction relative to the sheath122and is permitted to rotate freely in a circumferential direction relative to the sheath122.

The sheath122of the guide catheter120is an elongated tubular component sized for insertion into a lumen, such as a blood vessel, within the human body. The sheath122of the guide catheter120has a proximal end124that extends outside of a patient, a distal end126, and defines a lumen128therethrough which other elements such as the treatment catheter102may be inserted. The handle130is coupled to the proximal end124of the sheath122and may be manipulated by an operator. The sheath122of the guide catheter120may be formed of a polymeric material, non-exhaustive examples of which include polyethylene, PEBA, polyamide and/or combinations thereof, either blended or co-extruded. Optionally, the sheath122of the guide catheter120or some portion thereof may be formed as a composite having a reinforcement material incorporated within a polymeric body in order to enhance strength and/or flexibility. Suitable reinforcement layers include braiding, wire mesh layers, embedded axial wires, embedded helical or circumferential wires, and the like.

The proximal end124of the sheath122extends into the handle130and is coupled thereto. The handle130includes a housing132, a strain relief component134at a proximal end thereof, a flush port136, an actuator138for controlling a steering mechanism of the guide catheter102, and the locking mechanism140. In an embodiment, the actuator138controls tensioning of one or more pull wires125(shown in the cross-sectional view ofFIG.1A) attached to the sheath122. The pull wire125is operable to bend the sheath122for steering the guide catheter120in situ and may be selectively tensioned via the user. The pull wire125may extend through a pull wire lumen123that extends adjacent or parallel to the lumen128, and terminates proximal to the distal end126of the sheath122. More particularly, the pull wire125is slidably disposed within the pull wire lumen123such that it may be selectively tensioned by the user to bend the distal portion of the guide catheter120. As used herein, “slidably” denotes back and forth movement in a longitudinal direction along or generally parallel to a central longitudinal axis LA of the assembly100. While the pull wire125is primarily housed or disposed within the pull wire lumen123of the sheath122, the proximal end thereof (not shown) proximally extends beyond the proximal end124of the sheath122and is accessible via the handle130to be pulled or pushed which results in controlled bending movement of the distal portion of the sheath122.

A proximal end of the pull wire125is coupled to the actuator138of the handle130and a distal end of the pull wire125is attached to the sidewall of the sheath122, adjacent to the distal end126of the sheath122. The pull wire125is thus accessible to a user via the actuator138of the handle130and the curvature of the distal portion of the guide catheter120can be changed based on the user manipulating the pull wire125via the actuator138of the handle130. In the embodiment depicted inFIG.1, the actuator138is a knob that is rotatable relative to the housing132of the handle130. When the knob is rotated in a first direction (i.e., one of clockwise or counter-clockwise), the pull wire125is retracted and placed under tension to bend or deflect the distal portion of the sheath122. Stated another way, when the pull wire125is retracted via actuation of the actuator138, the pull wire125is placed under tension and bends the distal portion of the sheath122. When the knob is rotated in a second direction opposite from the first direction (i.e., the other of clockwise or counter-clockwise), tension on the pull wire125is released and the distal portion of the sheath122resumes its straightened configuration. Accordingly, the distal portion of the guide catheter120may be bent in a first direction via activation of the pull wire125. If it is desired to bend or deflect the distal portion of the guide catheter120in an opposing direction (i.e., a second direction opposite from the first direction), the guide catheter120may be torqued or rotated approximately 180 degrees and then the pull wire125may be actuated to bend the distal portion of the guide catheter120. The dimension of the radius of curvature depends upon the intended application of the guide catheter120, the target anatomy for use of the guide catheter120, and/or the size or profile of the guide catheter120.

In the embodiment depicted inFIGS.1,1A, and2, the treatment catheter102is a balloon catheter having an inflatable balloon108for radially expanding a balloon-expandable prosthesis110mounted on the balloon108. The balloon-expandable prosthesis110is shown in its delivery or unexpanded configuration inFIG.1and is shown in an expanded or deployed configuration inFIG.2. As will be understood by those of ordinary skill in the art, the balloon-expandable prosthesis110is radially expanded or deployed in situ by the balloon108and released from the treatment catheter102at a desired location in a patient's body lumen. An exemplary balloon-expandable prosthesis, and the expanded or deployed configuration thereof, is described in more detail in U.S. patent application Ser. No. 16/778,688, filed Jan. 31, 2020, herein incorporated by reference in its entirety. However, the configuration of the balloon-expandable prosthesis110is merely exemplary, and it would be apparent to one of ordinary skill in the art that the treatment catheter102may be utilized for delivering and deploying various types or configurations of prostheses. Further, although depicted as a balloon catheter for delivering the balloon-expandable prosthesis110, the treatment catheter102is not required to be configured for delivering a prosthesis but rather the treatment catheter102may be utilized in other procedures or for other purposes including diagnostic purposes. In addition, although embodiments hereof are shown with the balloon-expandable prosthesis110mounted over the balloon108in a delivery configuration, the balloon-expandable prosthesis110may be mounted proximal to the balloon108during delivery and the balloon108may be proximally retracted in situ to position the balloon108under the balloon-expandable prosthesis110for deployment thereof.

The treatment catheter102includes a proximal portion111that extends out of the patient during clinical use and has a handle115. As would be understood by one of ordinary skill in the art of balloon catheter design, the handle115includes a bifurcated luer116or other type of fitting that may be connected to a source of inflation fluid and may be of another construction or configuration without departing from the scope of the present invention. A distal portion113of the treatment catheter102is positionable at a target treatment location and includes the balloon108, which is shown in an unexpanded configuration inFIG.1and is shown in an expanded or inflated configuration inFIG.2. Stated another way, the balloon108is expandable from a first diameter shown inFIG.1to a second diameter shown inFIG.2, the second diameter being greater than the first diameter. The balloon108may be made of a biocompatible material such as a thermoplastic polyurethane (TPU) resin, styrene-ethylene-butadiene-styrene (SEBS), PEBAX®, or other suitable polymeric material used for dilatation balloon manufacturing.

With reference to theFIG.1Awhich is a cross-sectional view taken along line A-A ofFIG.1, the treatment catheter102may have an over-the-wire coaxial catheter configuration with an outer tubular component or outer shaft104and an inner tubular component or inner shaft106. A proximal end of the outer shaft104is coupled to the handle115and a distal end of the outer shaft104is coupled to a proximal end of the balloon108. The inner shaft106is disposed through the outer shaft104. The inner shaft106defines a guidewire lumen114extending substantially the entire length of the treatment catheter102for accommodating a guidewire (not shown) such that the treatment catheter102may be slidingly disposed and tracked over the guidewire. The inner shaft106has a proximal end (obscured from view inFIGS.1and2) coupled to the handle115and a distal end terminating distally of the balloon108and defining a distal guidewire port. Stated another way, the guidewire lumen114is open at the distal end of the inner shaft106. A distal tip119is attached to the distal end of the inner shaft106, and the distal tip119forms the distal end of the treatment catheter102. The inner shaft106extends coaxially within the outer shaft104such that an annular inflation lumen112is defined between an inner surface of the outer shaft104and an outer surface of the inner shaft106. The annular inflation lumen112is in fluid communication with an interior of the balloon108, and extends through the outer shaft104and into the inner volume of the balloon108to allow inflation fluid received through an inflation port118of the bifurcated luer116of the handle115to be delivered to the balloon108. A distal end of the balloon108is coupled to the inner shaft106at a position proximal to the distal end of the inner shaft.

Other types of catheter construction are also amendable to the invention, such as, without limitation thereto, a catheter shaft formed by multi-lumen profile extrusion. For example, rather than including coaxial inner and outer catheter shafts, the balloon catheter may include a single catheter shaft that defines an inflation lumen and a guidewire lumen, each extending substantially the entire length of the catheter and parallel to each other. Stated another way, the inflation and guidewire lumens may be defined or preformed in a sidewall of a single catheter shaft. In yet another embodiment, the inflation lumen may alternatively be formed via an elongated inflation tube disposed within and attached to the outer shaft104, as will be understood by those of ordinary skill in the art of balloon catheter construction. In addition, the treatment catheter102may have a rapid-exchange configuration with the guidewire lumen extending only along a distal portion of the catheter, as understood by those of ordinary skill in the art.

When positioning the treatment catheter102in situ, it may be necessary to torque or rotate the treatment catheter102in order to properly position the balloon-expandable prosthesis110within a native annulus prior to deployment of the balloon-expandable prosthesis110. Steering of the system100is accomplished via the flexing or bending of the sheath122and manipulation of the pull wire125as described above, and permits the user to navigate the system100through curved anatomy such as the aortic arch. Rotation or torqueing of the treatment catheter102assists the user in properly aligning the balloon-expandable prosthesis110within the target site, i.e., the native annulus. For example, the balloon-expandable prosthesis110needs to be properly aligned, axially and annularly/circumferentially, so that the balloon-expandable prosthesis110properly engages the native leaflets/tissue of the target site, e.g., the aortic annulus, without causing conduction blockages by implanting too deep or causing an embolization of the balloon-expandable prosthesis110because it was implanted too high. Torqueing the treatment catheter102is accomplished via rotation thereof, and permits the user to circumferentially align the balloon-expandable prosthesis110within the target site, e.g., the native annulus AN, in situ. When being positioned in situ, it is very important to avoid blocking the ostia of the right coronary artery and/or the left main coronary artery. Proper circumferential or rotational orientation within the target site reduces the risk of blocking coronary access. In addition, it may be desired to rotationally align commissures of the balloon-expandable prosthesis110with the native valve commissures. Commissure to commissure alignment (prosthesis commissure to native commissure) may improve hemodynamics and leaflet durability of the balloon-expandable prosthesis110. To circumferentially align the balloon-expandable prosthesis110, the balloon-expandable prosthesis110can rotated in situ to be positioned in a desired circumferential or rotational alignment.

The locking mechanism140of the handle130permits precise positioning of the treatment catheter102relative to the guide catheter102. More particularly, the locking mechanism140permits a user to selectively rotate and/or axially translate the treatment catheter102in order to position the balloon-expandable prosthesis100as desired. The locking mechanism140includes an unlocked state or configuration in which the treatment catheter102is permitted to slide freely in a longitudinal direction relative to the guide catheter102and is permitted to rotate freely in a circumferential direction relative to the guide catheter102, and also includes a locked state or configuration in which the treatment catheter102is not permitted to slide freely in the longitudinal direction relative to the guide catheter120and is not permitted to rotate freely in the circumferential direction relative to the guide catheter120. In addition to the unlocked and locked configuration, the locking mechanism140further includes a first semi-locked state or configuration and a second semi-locked state or configuration. In the first semi-locked state, the treatment catheter102is permitted to slide freely in a longitudinal direction relative to the guide catheter120and is not permitted to rotate freely in a circumferential direction relative to the guide catheter120, thereby restricting the treatment catheter102to only longitudinal movement in the proximal or distal direction while preventing inadvertent rotation of the treatment catheter102. In the second semi-locked state or configuration, the treatment catheter102is not permitted to slide freely in a longitudinal direction relative to the guide catheter120and is permitted to rotate freely in a circumferential direction relative to the guide catheter120, thereby permitting torqueing or rotation of the treatment catheter102while preventing inadvertent translation of the treatment catheter102in the proximal or distal direction. During positioning of the balloon-expandable prosthesis110, a user may desire to only adjust the longitudinal position of the treatment catheter102or may desire to only adjust the circumferential position of the treatment catheter102. The locking mechanism140thus allows a user to control which type of movement, i.e., longitudinal and/or circumferential, of the treatment catheter102is permitted and prevents any undesirable movement of the treatment catheter102.

The locking mechanism140is described in more detail herein with reference toFIGS.3-16.FIG.3is a perspective view of the locking mechanism140removed from the handle130of the system100for sake of illustration, andFIG.3Ais a sectional line taken along line A-A ofFIG.3. The locking mechanism140includes a collet142, a locking collar170, and a locking bearing180. As will be described in more detail herein, each of the locking collar170and the locking bearing180is slidingly disposed over the collet142. Each of the locking collar170and the locking bearing180is configured to slide, translate, or move in a longitudinal direction by the user between at least a first or non-engaged position on the collet142and a second or engaged position on the collet142.

With reference toFIGS.3-6, the collet142is a generally tubular element having a first end144and a second or opposing end146.FIG.4is an end view of the locking mechanism140from the first end144of the collet142, andFIG.5is an end view of the locking mechanism140from the second end146of the collet142. A flange145is formed on the first end144. The collet142has a first wall thickness T1at the first end144and a second wall thickness T2at the second end146. The second wall thickness T2is less than the first wall thickness T1. The wall thickness of the collet142gradually tapers from the first wall thickness T1to the second wall thickness T2. As a result of the tapering wall thickness, the collet142has a first outer diameter D1at the first end144and a second outer diameter D2at the second end146. The second outer diameter D2is less than the first outer diameter D1. Approximately half or mid-way along the length of the collet142, the collet142has a third outer diameter D3that is less than the first outer diameter D1and is greater than the second outer diameter D2.

As best shown onFIGS.6and7, the collet142includes a first plurality of slots148extending from the first end144, towards the second end146.FIG.6is a perspective view of the collet142, andFIG.7is an end view of the collet142from the first end144of the collet142. The first plurality of slots148do not extend to the second end146, and therefore form a first plurality of integral tabs150that circumferentially spaced apart around the first end144of the collet142. Each tab150of the first plurality of integral tabs150is defined by a pair of adjacent slots148of the first plurality of slots148. The first plurality of slots148permit the first end144of the collet142to be radially compressible. When radially compressed, the width of the slots148decreases until adjacent tabs150of the first plurality of integral tabs150are wedged against each other.

As best shown inFIGS.6and8, the collet142similarly includes a second plurality of slots152extending from the second end146, towards the first end144.FIG.6is a perspective view of the collet142, andFIG.8is an end view of the collet142from the second end146of the collet142. The second plurality of slots152do not extend to the first end144, and therefore form a second plurality of integral tabs154that circumferentially spaced apart around the second end146of the collet142. Each tab154of the second plurality of integral tabs154is defined by a pair of adjacent slots152of the second plurality of slots152. The second plurality of slots152permit the second end146of the collet142to be radially compressible. When radially compressed, the width of the slots152decreases until adjacent tabs154of the second plurality of integral tabs154are wedged against each other. The first plurality of slots148are circumferentially offset from the second plurality of slots152, with each slot148extending approximately half-way between a pair of adjacent slots152and each slot152extending approximately half-way between a pair of adjacent slots148.

As shown in each ofFIGS.6,7, and8, the collet142includes an inner surface155with a sinusoidal configuration including a plurality of peaks156and a plurality of valleys158. Each valley158is formed between a pair of adjacent peaks156. Each tab150of the first plurality of integral tabs150includes two peaks156and a valley158formed therebetween. Similarly, each tab154of the second plurality of integral tabs154includes two peaks156and a valley158formed therebetween.

With reference toFIGS.3,4,5,7A, and8A, the treatment catheter102includes a locking interface160on an outer surface thereof. In an embodiment, the locking interface160is formed as a separate component and is disposed on an outer surface of the treatment catheter102via any suitable mechanical method such as laser welding, heat welding, over-molding, adhesive binding, or other mechanical locking feature such as a threaded interface or a snap fit feature. The locking interface160is secured or fixed to the outer surface of the treatment catheter102so as to move as a single or unitary assembly. Stated another way, the locking interface160is fixed relative to the treatment catheter102such that they cannot move rotationally or axially relative to each other. In another embodiment hereof, the locking interface160may be integrally formed on an outer surface of the treatment catheter102. The locking interface160has an outer surface162with a scalloped configuration including a plurality of grooves164and a plurality of ridges166. Each groove164is formed between a pair of adjacent ridges166. The collet142is disposed over the locking interface160and each groove164of the locking interface160is configured to receive a pair of adjacent peaks156of the collet142. Stated another way, each groove164of the locking interface160is sized to receive two adjacent peaks156of the inner surface155of the collet142. The scalloped configuration of the outer surface162of the locking interface is exemplary and the number of the plurality of grooves164and the plurality of ridges166may vary from that shown herein. For example, the locking interface160may include a fewer number of alternating ridges and grooves than shown, and the ridges and grooves are not required to be equally spaced around the outer surface162of the locking interface160. The number of grooves164are not required to match or equal the number of ridges166. Alternative embodiments of the scalloped configuration are described in more detail herein with respect toFIGS.20-22.

As best shown onFIG.7A, which is an end view of the first end144of the collet142and the locking interface160disposed therein, at the first end144of the collet142, each ridge166of the locking interface160aligns with a valley158of the inner surface155of the collet142. Further, at the first end144of the collet142, each slot148of the first plurality of slots148extends between the two adjacent peaks156that are received within the groove164of the locking interface160.

As best shown onFIG.8A, which is an end view of the second end146of the collet142and the locking interface160disposed therein, at the second end146of the collet142, each ridge166of the locking interface160aligns with a slot152of the second plurality of slots152. Further, at the second end146of the collet142, a valley158extends between the two adjacent peaks156that are received within the groove164of the locking interface160.

With additional reference toFIG.9, the locking collar170is an annular or ring element that is slidingly disposed over the outer surface of the collet142, and may be moved or translated in a longitudinal direction by the user. The locking collar170is accessible to the user via an actuator117, which may be a slider, switch, or any suitable mechanical device that extends through the housing132and is externally accessible such that the locking collar170may be manipulated or moved by the user. An inner surface174of the locking collar170is sized or configured to have a minimum inner diameter D4, which is equal to or substantially similar to the third outer diameter D3of the collet142and is less than the first outer diameter D1of the collet142. In an embodiment, as best shown inFIG.3A, the inner surface174of the locking collar170is angled or tapered to correspond or mate with the tapered outer surface of the collet142. In another embodiment, the inner surface174of the locking collar is not angled or tapered but rather has a cylindrical inner surface with the collet142having a tapered outer surface such that there is a point of contact between the sliding surfaces. In the first or non-engaged position on the collet142, as shown onFIG.9A, the locking collar170is disposed over a midportion of the collet142. In the first or non-engaged position on the collet142, the inner surface174of the locking collar170may contact the outer surface of the collet142but the locking collar170does not radially compress the collet142since the minimum inner diameter D4of the locking collar170is equal to or substantially similar to the third outer diameter D3of the collet142at the midportion of the collet142. In the second or engaged position on the collet142, which is shown onFIG.9B, the locking collar170is disposed adjacent to or near the first end144of the collet142. In the second or engaged position on the collet142, the inner surface174of the locking collar170contacts the outer surface of the collet142and the locking collar170radially compresses the collet142since the minimum inner diameter D4of the locking collar170is less than the first outer diameter D1of the collet142at the first end144thereof. Thus, as the locking collar170is moved from the first or non-engaged position on the collet142towards the second or engaged position on the collet142, the locking collar170radially compresses the first end144of the collet142.

When the locking collar170is in the second or engaged position on the collet142, the locking collar170radially compresses the collet142and thereby prevents or restricts rotation of the treatment catheter102. As best shown in the enlarged perspective view ofFIG.11, when the first end144of the collet142is radially compressed by the locking collar170, each ridge166of the locking interface160extends into or is received within a valley158of the inner surface155of the collet142. With the ridges166of the locking interface160protruding into valleys158of the collet142, the locking interface160and treatment catheter102attached thereto is prevented from rotating. Thus, when the locking collar170is in the second or engaged position on the collet142, the treatment catheter102is no longer permitted to be rotated relative to the guide catheter102. However, when the locking collar170is in the second or engaged position on the collet142, the locking collar170still permits axial translation of the treatment catheter102because the ridges166of the locking interface160are permitted to slide within the valleys158of the collet142.

Notably, although the locking collar170is described herein as having only two positions, i.e., a first or non-engaged position and a second or engaged position, it will be understood that the locking collar170has numerous positions intermediate or in between the first and second positions. As the locking collar170is advanced from the midportion of the collet142towards the first end144of the collet142, over the tapered outer surface of the collet142, gradual radial compression of the collet142occurs. As used herein, the first or non-engaged position includes a range of positions of the locking collar170relative to the collet142in which the locking collar170does not radially compress the collet142to the extent by which rotation of the treatment catheter102is prevented. Conversely, as used herein, the second or engaged position includes a range of positions of the locking collar170relative to the collet142in which the locking collar170radially compresses the collet142to the extent by which rotation of the treatment catheter102is prevented.

With additional reference toFIG.10, the locking bearing180is a ball bearing that is slidingly disposed over the outer surface of the collet142, and may be moved or translated in a longitudinal direction by the user. The locking bearing180is accessible to the user via an actuator121, which may be a slider, switch, or any suitable mechanical device that extends through the housing132and is externally accessible such that the locking bearing180may be manipulated or moved by the user. An inner surface184of the locking bearing180is sized or configured to have a minimum inner diameter D5, which is equal to or slightly greater than the second outer diameter D2of the collet142and is less than the third outer diameter D3of the collet142. In an embodiment, as best shown inFIG.3A, the inner surface184of the locking bearing180is angled or tapered to correspond or mate with the tapered outer surface of the collet142. In another embodiment, the inner surface184of the locking bearing is not angled or tapered but rather has a cylindrical inner surface with the collet142having a tapered outer surface such that there is a point of contact between the sliding surfaces. The locking bearing180includes an inner bearing race186, an outer bearing race188, and a plurality of balls190disposed between the inner and outer bearing races186,188. The inner and outer bearing races186,188are concentric annular or ring components, and the inner bearing race186is disposed or positioned within the outer bearing race188. When one of the inner bearing race186and the outer bearing race188rotates, the rotation thereof causes the balls190to rotate as well while the non-rotating bearing race stays stationary. For example, rotation of the inner bearing race186causes the balls190to rotate as well, such that the inner bearing race186and the balls190rotate relative to the outer bearing race188.

In the first or non-engaged position on the collet142, which is shown inFIG.10A, the locking bearing180is disposed over the second end146of the collet142. In the first or non-engaged position on the collet142, the inner surface184of the locking bearing180may contact the outer surface of the collet142but the locking bearing180does not radially compress the collet142since the minimum inner diameter D5of the locking bearing180is equal to or slightly greater than the second outer diameter D2of the collet142at the second end146of the collet142. In the second or engaged position on the collet142, the locking bearing180is disposed adjacent to or near the midportion of the collet142. In the second or engaged position on the collet142, which is shown inFIG.10B, the inner surface184of the locking bearing180contacts the outer surface of the collet142and the locking bearing180radially compresses the collet142since the minimum inner diameter D5of the locking bearing180is less than the third outer diameter D2of the collet142at the midportion thereof. Thus, as the locking bearing180is moved from the first or non-engaged position on the collet142towards the second or engaged position on the collet142, the locking bearing180radially compresses the midportion of the collet142.

When the locking bearing180is in the second or engaged position on the collet142, the locking bearing180radially compresses the collet142and thereby prevents or restricts axial translation of the treatment catheter102. As best shown on the enlarged perspective view ofFIG.12, when the midportion of the collet142is radially compressed by the locking bearing180, each tab154of the second plurality of tabs154are wedged into a groove164of the locking interface160. Each tab154of the second plurality of tabs154includes two adjacent peaks156and a valley158therebetween, with two slots152on either side of the tab154. With slots152on either side of each tab154, the tabs154are pushed into the grooves164of the locking interface160and the midportion of the collet142is radially compressed by the locking bearing180. With the tabs154wedged into the grooves164, the locking interface160and treatment catheter102attached thereto cannot move axially, or are not permitted to move axially, under normal operating conditions. Thus, when the locking bearing180is in the second or engaged position on the collet142, the treatment catheter102is no longer permitted to be axially translated or moved in a longitudinal direction relative to the guide catheter102.

However, when the locking bearing180is in the second or engaged position on the collet142, the locking bearing180still permits rotation of the treatment catheter102because the inner bearing race186rotates relative to the outer bearing race188. More particularly, with the tabs154of the collet142wedged into the grooves164of the locking interface160, the collet142is mechanically interlocked with the locking interface160. When a user rotates the treatment catheter102(thus rotating the locking interface160attached thereto), the assembly of the collet142and the inner bearing race186rotates therewith. Although the locking bearing180is radially compressing the midportion of the collet142, the locking bearing180still permits rotation of the collet since the locking bearing180is a ball bearing. The inner bearing race186and balls190rotate with the collet142, while outer bearing race188stays stationary.

Notably, although the locking bearing180is described herein as having only two positions, i.e., a first or non-engaged position and a second or engaged position, it will be understood that the locking bearing180has numerous positions intermediate or in between the first and second positions. As the locking bearing180is advanced from the second end146towards the midportion of the collet142, over the tapered outer surface of the collet142, gradual radial compression of the collet142occurs. As used herein, the first or non-engaged position includes a range of positions of the locking bearing180relative to the collet142in which the locking bearing180does not radially compress the collet142to the extent by which axial translation of the treatment catheter102is prevented. Conversely, as used herein, the second or engaged position includes a range of positions of the locking bearing180relative to the collet142in which the locking bearing180radially compresses the collet142to the extent by which axial translation of the treatment catheter102is prevented.

The four states or configurations of the locking mechanism140(a locked state, an unlocked state, a first semi-locked state, and a second semi-locked state) are described in turn in more detail below. As described above, the locking mechanism140includes an unlocked state or configuration in which the treatment catheter102is permitted to slide freely in a longitudinal direction relative to the guide catheter102and is permitted to rotate freely in a circumferential direction relative to the guide catheter102. In the unlocked state or configuration, which is shown inFIG.13, each of the locking collar170and the locking bearing180is disposed in the first or non-engaged position on the collet142. More particularly, in the first or non-engaged position on the collet142, the locking collar170is disposed over a midportion of the collet142and the locking bearing180is disposed over the second end146of the collet142. In the first or non-engaged position on the collet142, neither the locking collar170nor the locking bearing180radially compresses the collet142. Thus, in the unlocked state or configuration of the locking mechanism140, the collet142does not interact with the locking interface160of the treatment catheter102and the treatment catheter102may be axially translated and/or rotated relative to the collet142by user manipulation of the treatment catheter102. For example, a user can axially translation or rotate the treatment catheter102via manipulation of bifurcated luer116which extends proximally from the handle130. Each of the locking collar170and the locking bearing180contacts and abuts against the collet142when in their respective first or non-engaged position in order to maintain or hold the collet142centrally around the locking collar170and prevent any inadvertent movement thereof. Stated another way, the locking collar170and the locking bearing180in their respective first or non-engaged positions maintain or hold the collet142in a radially spaced position relative to the locking interface160.

The locking mechanism140also includes a locked state or configuration in which the treatment catheter102is not permitted to slide freely in the longitudinal direction relative to the guide catheter120and is not permitted to rotate freely in the circumferential direction relative to the guide catheter120. In the locked state or configuration, which is shown inFIG.14, each of the locking collar170and the locking bearing180is disposed in the second or engaged position on the collet142. More particularly, in the second or engaged position on the collet142, the locking collar170is disposed over the first end144of the collet142and the locking bearing180is disposed over the midportion of the collet142. In the second or engaged position on the collet142, both the locking collar170and the locking bearing180radially compresses the collet142.

More particularly, when the locking collar170is in the second or engaged position on the collet142, the locking collar170radially compresses the collet142and thereby prevents or restricts rotation of the treatment catheter102. When the first end144of the collet142is radially compressed by the locking collar170, each ridge166of the locking interface160extends into or is received within a valley158of the inner surface155of the collet142. With the ridges166of the locking interface160protruding into valleys158of the collet142, the locking interface160and treatment catheter102attached thereto is prevented from rotating. Thus, when the locking collar170is in the second or engaged position on the collet142, the treatment catheter102is no longer permitted to be rotated relative to the guide catheter102.

When the locking bearing180is in the second or engaged position on the collet142, the locking bearing180radially compresses the collet142and thereby prevents or restricts axial translation of the treatment catheter102. When the midportion of the collet142is radially compressed by the locking bearing180, each tab154of the second plurality of tabs154are wedged into a groove164of the locking interface160. Each tab154of the second plurality of tabs154includes two adjacent peaks156and a valley158therebetween, with two slots152on either side of the tab154. With slots152on either side of each tab154, the tabs154are pushed into the grooves164of the locking interface160the midportion of the collet142is radially compressed by the locking bearing180. With the tabs154wedged into the grooves164, the locking interface160and treatment catheter102attached thereto cannot move axially, or are not permitted to move axially, under normal operating conditions. Thus, when the locking bearing180is in the second or engaged position on the collet142, the treatment catheter102is no longer permitted to be axially translated or moved in a longitudinal direction relative to the guide catheter102.

The locking mechanism140also includes a first semi-locked state or configuration in which the treatment catheter102is permitted to slide freely in a longitudinal direction relative to the guide catheter120and is not permitted to rotate freely in a circumferential direction relative to the guide catheter120, thereby restricting the treatment catheter102to only longitudinal movement in the proximal or distal direction while preventing inadvertent rotation of the treatment catheter102. In the first semi-locked state or configuration, which is shown inFIG.15, the locking collar170is disposed in the second or engaged position and the locking bearing180is disposed in the first or non-engaged position on the collet. More particularly, the locking collar170is disposed over the first end144of the collet142and the locking bearing180is disposed over the second end146of the collet142.

In the first or non-engaged position on the collet142, the locking bearing180is disposed over the second end146of the collet142and does not radially compress the collet142. Thus, when the locking bearing180is in the first or non-engaged position on the collet142, the locking bearing180is not causing the collet142to restrict or prevent any movement of the treatment catheter102. Stated another way, with the locking bearing180at the second end146of the collet142, the second end146of the collet142does not interact with the locking interface160of the treatment catheter102and the treatment catheter102may be axially translated and/or rotated relative to the collet142by user manipulation of the treatment catheter102.

When the locking collar170is in the second or engaged position on the collet142, the locking collar170radially compresses the first end144of the collet142and thereby prevents or restricts rotation of the treatment catheter102. When the first end144of the collet142is radially compressed by the locking collar170, each ridge166of the locking interface160extends into or is received within a valley158of the inner surface155of the collet142. With the ridges166of the locking interface160protruding into valleys158of the collet142, the locking interface160and treatment catheter102attached thereto is prevented from rotating. Thus, when the locking collar170is in the second or engaged position on the collet142, the treatment catheter102is no longer permitted to be rotated relative to the guide catheter102. However, when the locking collar170is in the second or engaged position on the collet142, the locking collar170still permits axial translation of the treatment catheter102because the ridges166of the locking interface160are permitted to slide within the valleys158of the collet142. Stated another way, the degree or amount of radial compression required for the locking collar170to be in the second or engaged position (and thereby prevent rotation of the treatment catheter102) does not interfere with axial translation of the treatment catheter102. The degree or amount radial compression is sufficient to ensure each ridge166of the locking interface160extends into or is received within a valley158of the inner surface155of the collet142to prevent rotation, but the locking collar170does not compress the collet142to the extent which would prevent axial translation.

The locking mechanism140also includes a second semi-locked state or configuration in which the treatment catheter102is not permitted to slide freely in a longitudinal direction relative to the guide catheter120and is permitted to rotate freely in a circumferential direction relative to the guide catheter120, thereby permitting torqueing or rotation of the treatment catheter102while preventing inadvertent translation of the treatment catheter102in the proximal or distal direction. In the second semi-locked state or configuration, which is shown inFIG.16, the locking collar170is disposed in the first or non-engaged position on the collet142and the locking bearing180is disposed in the second or engaged position on the collet. More particularly, each of the locking collar170and the locking bearing180is disposed over the midportion of the collet142.

In the first or non-engaged position on the collet142, the locking collar170is disposed over the midportion of the collet142and does not radially compress the collet142. Thus, when the locking collar170is in the first or non-engaged position on the collet142, the locking collar170is not causing the collet142to restrict or prevent any movement of the treatment catheter102. Stated another way, with the locking collar170at the midportion of the collet142, the locking collar170is not causing the midportion of the collet142to interact with the locking interface160of the treatment catheter102and the treatment catheter102may be axially translated and/or rotated relative to the collet142by user manipulation of the treatment catheter102.

When the locking bearing180is in the second or engaged position on the collet142, the locking bearing180radially compresses the midportion of the collet142and thereby prevents or restricts axial translation of the treatment catheter102. When the midportion of the collet142is radially compressed by the locking bearing180, each tab154of the second plurality of tabs154are wedged into a groove164of the locking interface160. Each tab154of the second plurality of tabs154includes two adjacent peaks156and a valley158therebetween, with two slots152on either side of the tab154. With slots152on either side of each tab154, the tabs154are pushed into the grooves164of the locking interface160the midportion of the collet142is radially compressed by the locking bearing180. With the tabs154wedged into the grooves164, the locking interface160and treatment catheter102attached thereto cannot move axially, or are not permitted to move axially, under normal operating conditions. Thus, when the locking bearing180is in the second or engaged position on the collet142, the treatment catheter102is no longer permitted to be axially translated or moved in a longitudinal direction relative to the guide catheter102. However, when the locking bearing180is in the second or engaged position on the collet142, the locking bearing180still permits rotation of the treatment catheter102because the inner bearing race186rotates relative to the outer bearing race188. More particularly, with the tabs154of the collet142wedged into the grooves164of the locking interface160, the collet142is mechanically interlocked with the locking interface160. When a user rotates the treatment catheter102(thus rotating the locking interface160attached thereto), the assembly of the collet142and the inner bearing race186rotates therewith. Although the locking bearing180is radially compressing the midportion of the collet142, the locking bearing180still permits rotation of the collet since the locking bearing180is a ball bearing. The inner bearing race186and balls190rotate with the collet142, while outer bearing race188stays stationary.

The handle130may also include an indexing component configured to output a tactile click at one or more defined degrees of rotation of the treatment catheter102. The indexing feature tracks user rotation of the treatment catheter102in defined increments. An exemplary indexing component1792that may be utilized in embodiments hereof is depicted inFIG.17. In the embodiment ofFIG.17, the indexing component1792includes an indexing finger or lever1794.FIG.17illustrates the locking mechanism140and the indexing component1792removed from the housing132of the handle130for sake of illustration. When assembled into the housing132, the indexing finger1794is disposed within the handle130, and includes a first end (not shown) attached to an interior surface of the housing132of the handle130and a second end that is unattached or free. The second end includes a radially-extending protrusion1795with a pointed tip1796. The indexing finger1794is configured to interact with the locking interface160to track rotation of the treatment catheter102. More particularly, the pointed tip1796of the indexing finger1794is sized and configured to be received within a single groove164of the locking interface160. The pointed tip1796moves to an adjacent groove164when the treatment catheter102and locking interface160attached thereto rotates. In an embodiment in which the locking interface160includes a total of six grooves164, movement between each groove indicates rotation of 60 degrees. Stated another way, when the locking interface160includes a total of six grooves164, the indexing finger1794tracks rotation of the treatment catheter102in stepped increments of 60 degrees each. It will be apparent to one of ordinary skill in the art that the locking interface160may be modified to include a greater or lesser number of grooves, and a greater number of grooves results in smaller stepped increments and a lesser number of grooves results in larger stepped increments. For example, if the locking interface is modified to include a total of 12 grooves, movement between each groove would indicate rotation of 30 degrees. A tactile click is output each time the indexing finger1794moves into a new groove164in order to provide tactile feedback of rotation to the user.

The indexing component1792may be utilized to track user rotation of the treatment catheter102while the locking mechanism140is in the an unlocked state or configuration, as well as when the locking mechanism is in the second semi-locked state or configuration. As described above with respect toFIG.13, in the unlocked state or configuration, the treatment catheter102is permitted to slide freely in a longitudinal direction relative to the guide catheter102and is permitted to rotate freely in a circumferential direction relative to the guide catheter102. Further, as described above with respect toFIG.16, in the second semi-locked state or configuration, the treatment catheter102is not permitted to slide freely in a longitudinal direction relative to the guide catheter120and is permitted to rotate freely in a circumferential direction relative to the guide catheter120, thereby permitting torqueing or rotation of the treatment catheter102while preventing inadvertent translation of the treatment catheter102in the proximal or distal direction. Since the indexing component1792is configured to interact with the locking interface160, the indexing component1792tracks user rotation of the treatment catheter102when the locking mechanism140is in either of these configurations.

Another exemplary indexing component1892that may be utilized in embodiments hereof is depicted inFIG.18. In the embodiment ofFIG.18, the indexing component1792includes a spring loaded ball bearing1894. The spring loaded ball bearing1894includes a housing1897, a spring1898disposed within the housing1897, and a sphere or ball1899partially disposed within the housing1897. The spring1898biases the sphere1899into an extended configuration or position, but permits the sphere1899to move within the housing1897when sufficient force is applied thereto.FIG.18illustrates the locking mechanism140and the indexing component1892removed from the housing132of the handle130for sake of illustration. When assembled into the housing132, the spring loaded ball bearing1894is disposed within the handle130, and includes a first end attached to an interior surface of the housing132of the handle130and a second end that is unattached or free. The second end includes the sphere1899. The sphere1899is configured to interact with the locking interface160to track rotation of the treatment catheter102. More particularly, the sphere1899of the spring loaded ball bearing1894is sized and configured to be received within a single groove164of the locking interface160. The sphere1899moves to an adjacent groove164when the treatment catheter102and locking interface160attached thereto rotates. When the treatment catheter102and locking interface160attached thereto is rotated, the sphere1899is pushed or moved into the housing1897due to longitudinal compression of the spring1898. Once the sphere1899is aligned with a groove164, the spring1898resumes its initial configuration and pushes or advanced the sphere1899back to the extended configuration in which the sphere1899is received within the groove164. In an embodiment in which the locking interface160includes a total of six grooves164, movement between each groove indicates rotation of 60 degrees. Stated another way, when the locking interface160includes a total of six grooves164, the spring loaded ball bearing1894tracks rotation of the treatment catheter102in stepped increments of 60 degrees each. It will be apparent to one of ordinary skill in the art that the locking interface160may be modified to include a greater or lesser number of grooves, and a greater number of grooves results in smaller stepped increments and a lesser number of grooves results in larger stepped increments. For example, if the locking interface is modified to include a total of 12 grooves, movement between each groove would indicate rotation of 30 degrees. A tactile click is output each time the sphere1899moves into a new groove164in order to provide tactile feedback of rotation to the user.

The indexing component1892may be utilized to track user rotation of the treatment catheter102while the locking mechanism140is in the an unlocked state or configuration, as well as when the locking mechanism is in the second semi-locked state or configuration. As described above with respect toFIG.13, in the unlocked state or configuration, the treatment catheter102is permitted to slide freely in a longitudinal direction relative to the guide catheter102and is permitted to rotate freely in a circumferential direction relative to the guide catheter102. Further, as described above with respect toFIG.16, in the second semi-locked state or configuration, the treatment catheter102is not permitted to slide freely in a longitudinal direction relative to the guide catheter120and is permitted to rotate freely in a circumferential direction relative to the guide catheter120, thereby permitting torqueing or rotation of the treatment catheter102while preventing inadvertent translation of the treatment catheter102in the proximal or distal direction. Since the indexing component1892is configured to interact with the locking interface160, the indexing component1792tracks user rotation of the treatment catheter102when the locking mechanism140is in either of these configurations.

Although indexing components1794,1894are described above as being configured to interact with the grooves164of the locking interface160, the indexing components may alternatively be configured to interact with the locking bearing180. More particularly, with reference toFIG.19, a locking bearing1980is shown that is configured to interact with indexing components1794,1894. The locking bearing1980includes an inner bearing race1986that includes an extension which is longer or extended relative to an outer bearing race1988thereof. The extension may be integral to or attached to the inner bearing race1986. When assembled over the treatment catheter102, the extension of the inner bearing race1986would be coaxially disposed over the locking interface160thereof (not shown inFIG.19). The extension of the inner bearing race1986provides an outer or exposed surface1987that includes a plurality of grooves1964formed thereon that are configured to interact with the indexing components1794,1894in a similar manner as the grooves164of the locking interface160. In this embodiment, however, the number of grooves1964on the extension of the inner bearing race1986may be solely chosen to optimize the increments for tracking rotation of the treatment catheter102. For example, in an embodiment hereof, in which the outer surface1987includes a total of thirty-six grooves1964, movement between each groove indicates rotation of 10 degrees. Stated another way, when the extension of the inner bearing race1986includes a total of thirty-six grooves1964on the outer surface1987thereof, the indexing component1794,1894tracks rotation of the treatment catheter102in stepped increments of 10 degrees each. It will be apparent to one of ordinary skill in the art that the extension of the inner bearing race1986may be modified to include a greater or lesser number of grooves, and a greater number of grooves results in smaller stepped increments and a lesser number of grooves results in larger stepped increments. For example, if the outer surface of the extension of the inner bearing race is modified to include a total of 18 grooves, movement between each groove would indicate rotation of 20 degrees.

In the embodiment ofFIG.19, the indexing component1792,1892may be utilized to track user rotation of the treatment catheter102while the locking mechanism140is in the second semi-locked state or configuration only. As described above with respect toFIG.16, in the second semi-locked state or configuration, the treatment catheter102is not permitted to slide freely in a longitudinal direction relative to the guide catheter120and is permitted to rotate freely in a circumferential direction relative to the guide catheter120, thereby permitting torqueing or rotation of the treatment catheter102while preventing inadvertent translation of the treatment catheter102in the proximal or distal direction. Since the indexing component1792,1892is configured to interact with the locking bearing1980, the indexing component1792,1892tracks user rotation of the treatment catheter102only when the inner bearing race1986is engaged and rotated via rotation of the treatment catheter102.

Although the locking mechanism140described herein includes a total of four states or configurations including a locked state, an unlocked state, a first semi-locked state, and a second semi-locked state, the locking mechanism140may be modified to permit various combinations of the above-referenced states. For example, in another embodiment hereof, the locking mechanism140may be modified such that only the locking collar170is permitted to switch between the engaged and non-engaged positions, while the locking bearing180is disposed at the engaged position. In such an embodiment, the locking mechanism would have only two states or configurations: (1) a first position in which the locking collar170is in the engaged position and neither longitudinal nor rotational movement of the treatment catheter102is permitted, and (2) a second position in which the locking collar170is in the non-engaged position and the locking mechanism allows the treatment catheter102to rotate relative to the guide catheter120but does not allow for longitudinal movement of the treatment catheter102. In such an embodiment, the locking collar170essentially functions as a switch which when toggled can permit or prevent rotation of the treatment catheter102relative to the guide catheter120. This embodiment may be desirable if the user has already located the balloon-expandable prosthesis110longitudinally and does not want the prosthesis to move longitudinally when rotated or torqued.

In another embodiment hereof, the locking mechanism140may be modified such that only the locking bearing180is permitted to switch between the engaged and non-engaged positions, while the locking collar170is disposed at the engaged position. In such an embodiment, the locking mechanism would have only two states or configurations: (1) a first position in which the locking bearing180is in the engaged position and neither longitudinal nor rotational movement of the treatment catheter102is permitted, and (2) a second position in which the locking bearing180is in the non-engaged position and the locking mechanism allows the treatment catheter102to move longitudinally relative to the guide catheter120but does not allow for rotation of the treatment catheter102. In such an embodiment, the locking bearing180essentially functions as a switch which when toggled can permit or prevent axial translation of the treatment catheter102relative to the guide catheter120.

In another embodiment hereof, the locking mechanism140may be modified such that only the locking bearing180is permitted to switch between the engaged and non-engaged positions, while the locking collar170is disposed at the non-engaged position. In such an embodiment, the locking mechanism would have only two states or configurations: (1) a first position in which the locking bearing180is in the engaged position and only rotational movement of the treatment catheter102is permitted, but does not allow for axial translation of the treatment catheter102, and (2) a second position in which the locking bearing180is in the non-engaged position and the locking mechanism allows for both rotational and longitudinal movement of the treatment catheter102. In such an embodiment, the locking bearing180essentially functions as a switch which when toggled can permit or prevent axial translation of the treatment catheter102relative to the guide catheter120.

The locking mechanism140is described herein for controlling relative movement between the treatment catheter102and the guide catheter120. However, the locking mechanism140may be utilized for controlling relative movement between any two catheter-type devices. The treatment catheter102is not required to be a balloon catheter but rather can any treatment or diagnostic catheter device, including for example, a stent delivery catheter, a drug delivery catheter, or an imaging catheter. The treatment catheter102may, for example, be a diagnostic catheter for measuring one or more hemodynamic conditions including ejection fraction, pressure differential, aortic jet velocity, or doppler velocity index. In another embodiment, the treatment catheter102may be configured for use in a valvuloplasty procedure or a catheter configured to deliver a device for repairing a native valve such as but not limited to an annuloplasty ring or band. Depending on the type of treatment or diagnostic catheter, the distal end portion thereof may include various types of medical components attached to or formed thereon. For example, if the catheter is a balloon catheter as described herein, the medical component at a distal end portion thereof is a balloon. In another embodiment, the catheter may be a diagnostic catheter and the medical component at a distal portion thereof includes a sensor or imaging device. In another embodiment, the catheter may be a treatment catheter such as a drug delivery catheter and the medical component at a distal portion thereof includes a drug delivery port.

As previously stated above, the scalloped configuration of the outer surface162of the locking interface is exemplary and the number of the plurality of grooves164and the plurality of ridges166may vary from that shown herein. For example, the locking interface160may include a fewer number of alternating ridges and grooves than shown, and the ridges and grooves are not required to be equally spaced around the outer surface162of the locking interface160. The number of grooves164are not required to match or equal the number of ridges166. In an embodiment, the locking interface may include single raised portion or ridge and at least two grooves formed on the outer surface. In another embodiment, the locking interface may include a single groove and at least two raised portions or ridges formed on the outer surface.

With respect toFIGS.20-22, an alternative embodiment is shown in which the locking interface includes a single longitudinally extending ridge for interfacing with the collet142. More particularly, a locking interface2060is shown that includes single ridge2066and a pair of adjacent grooves2064formed on an outer surface2062thereof. In this embodiment, the single ridge2066is formed between the pair of adjacent grooves2064. Each groove2064of the pair of adjacent grooves2064is longitudinally extending, and extends at least the length of the collet142disposed thereover. Similarly, the single ridge2066is longitudinally extending, and extends at least the length of the collet142disposed thereover.

The collet142is disposed over the locking interface2060. At the first end144of the collet142, as best shown inFIG.21, the single ridge2066of the locking interface2060aligns with a valley158of the inner surface of the collet142. At the second end146of the collet142, as best shown inFIG.22, the single ridge2066of the locking interface2060aligns with a slot152of the second plurality of slots152.

When the locking collar170is in the second or engaged position on the collet142, the locking collar170radially compresses the collet142and thereby prevents or restricts rotation of the treatment catheter102. With reference toFIG.21, when the first end144of the collet142is radially compressed by the locking collar170, the single ridge2066of the locking interface2060extends into or is received within a valley158of the inner surface of the collet142. With the single ridge2066of the locking interface2060protruding into a valley158of the collet142, the locking interface160and treatment catheter102attached thereto is prevented from rotating because the single ridge2066is disposed within the valley158, between two adjacent peaks156of the collet142. However, when the locking collar170is in the second or engaged position on the collet142, the locking collar170still permits axial translation of the treatment catheter102because the single ridge2066of the locking interface2060is permitted to slide within the valley158of the collet142.

When the locking bearing180is in the second or engaged position on the collet142, the locking bearing180radially compresses the collet142and thereby prevents or restricts axial translation of the treatment catheter102. With reference toFIG.22, when the midportion of the collet142is radially compressed by the locking bearing180, the single ridge2066is wedged into a slot152of the second plurality of slots152. With the single ridge2066is wedged into a slot152, the locking interface2060and treatment catheter102attached thereto cannot move axially, or are not permitted to move axially, under normal operating conditions. Thus, when the locking bearing180is in the second or engaged position on the collet142, the treatment catheter102is no longer permitted to be axially translated or moved in a longitudinal direction relative to the guide catheter102. However, when the locking bearing180is in the second or engaged position on the collet142, the locking bearing180still permits rotation of the treatment catheter102because the inner bearing race186rotates relative to the outer bearing race188. More particularly, with the single ridge2066is wedged into a slot152, the collet142is mechanically interlocked with the locking interface2060. When a user rotates the treatment catheter102(thus rotating the locking interface2060attached thereto), the assembly of the collet142and the inner bearing race186rotates therewith. Although the locking bearing180is radially compressing the midportion of the collet142, the locking bearing180still permits rotation of the collet since the locking bearing180is a ball bearing. The inner bearing race186and balls190rotate with the collet142, while outer bearing race188stays stationary.

The configuration of the inner surface of the collet142is also exemplary and the number of the peaks and valleys formed thereon may vary from that shown herein. For example, the collet142may include a fewer number of alternating peaks and valleys than shown, and the peaks and valleys are not required to be equally spaced around the inner surface of the collet142. The number of peaks are not required to match or equal the number of grooves. In an embodiment, the collet may include a pair of peaks and a single groove formed on the inner surface thereof.

For example,FIGS.23-26illustrate an alternative embodiment of a collet2342for interfacing with the locking interface160. More particularly, the collet2342is a generally tubular element having a first end2344and a second or opposing end2346.FIG.23is a perspective end view from the first end2344of the collet2342, andFIG.24is a perspective end view from the second end2346of the collet2342. Similar to collet142, a flange2345is formed on the first end2344of the collet2342and the wall thickness of the collet2342tapers from a first wall thickness at the first end2344to a second wall thickness at the second end2346.

The collet2342includes a first plurality of slots2348extending from the first end2344, towards the second end2346. The first plurality of slots2348do not extend to the second end2346, and therefore form a first plurality of integral tabs2350that circumferentially spaced apart around the first end2344of the collet2342. Each tab2350of the first plurality of integral tabs2350is defined by a pair of adjacent slots2348of the first plurality of slots2348. The first plurality of slots2348permit the first end2344of the collet2342to be radially compressible. When radially compressed, the width of the slots2348decreases until adjacent tabs2350of the first plurality of integral tabs2350are wedged against each other.

The collet2342similarly includes a second plurality of slots2352extending from the second end2346, towards the first end2344. The second plurality of slots2352do not extend to the first end2344, and therefore form a second plurality of integral tabs2354that circumferentially spaced apart around the second end2346of the collet2342. Each tab2354of the second plurality of integral tabs2354is defined by a pair of adjacent slots2352of the second plurality of slots2352. The second plurality of slots2352permit the second end2346of the collet2342to be radially compressible. When radially compressed, the width of the slots2352decreases until adjacent tabs2354of the second plurality of integral tabs2354are wedged against each other. The first plurality of slots2348are circumferentially offset from the second plurality of slots2352, with each slot2348extending approximately half-way between a pair of adjacent slots2352and each slot2352extending approximately half-way between a pair of adjacent slots2348.

The collet2342includes an inner surface with a pair of peaks2356and a valley2358. The valley2358is formed between the adjacent peaks2356. In this embodiment, two adjacent tabs2350of the plurality of tabs2350each include a single peak2356of the pair of peaks2356and a single tab2354of the second plurality of integral tabs2354includes the pair of peaks2356and the valley2358formed therebetween. As best shown onFIG.25, which is a perspective end view of the first end2344of the collet2342and the locking interface160disposed therein, at the first end2344of the collet2342, the pair of peaks2356is aligned within a groove164of the locking interface160at the first end2344of the collet2342. When the locking collar170is in the second or engaged position on the collet2342, the locking collar170radially compresses the collet2342and thereby prevents or restricts rotation of the treatment catheter102. When the first end2344of the collet2342is radially compressed by the locking collar170, the pair of peaks2356are compressed into the groove164such that the pair of peaks2356are sandwiched or disposed between two ridges166of the locking interface160. With the pair of peaks2356compressed into the groove164, the locking interface160and treatment catheter102attached thereto is prevented from rotating. Thus, when the locking collar170is in the second or engaged position on the collet2342, the treatment catheter102is no longer permitted to be rotated relative to the guide catheter102. However, when the locking collar170is in the second or engaged position on the collet2342, the locking collar170still permits axial translation of the treatment catheter102because the pair of peaks2356compressed into the groove164are permitted to slide within the groove164.

As best shown onFIG.26, which is a perspective end view of the second end2346of the collet2342and the locking interface160disposed therein, at the second end2346of the collet2342, the single tab2354of the second plurality of integral tabs2354which includes the pair of peaks2356and the valley2358formed therebetween is aligned with a groove164of the locking interface. When the locking bearing180is in the second or engaged position on the collet2342, the locking bearing180radially compresses the collet2342and thereby prevents or restricts axial translation of the treatment catheter102. When the midportion of the collet2342is radially compressed by the locking bearing180, the single tab of the second plurality of integral tabs2354that includes the pair of peaks2356and the valley2358formed therebetween is wedged into a groove164of the locking interface160. With slots2352on either side of this single tab2354, the single tab of the second plurality of integral tabs2354which includes the pair of peaks2356and the valley2358formed therebetween is pushed into a groove164of the locking interface160and the midportion of the collet2342is radially compressed by the locking bearing180. With the single tab of the second plurality of integral tabs2354which includes the pair of peaks2356and the valley2358formed therebetween wedged into a groove164, the locking interface160and treatment catheter102attached thereto cannot move axially, or are not permitted to move axially, under normal operating conditions. Thus, when the locking bearing180is in the second or engaged position on the collet2342, the treatment catheter102is no longer permitted to be axially translated or moved in a longitudinal direction relative to the guide catheter102.

However, when the locking bearing180is in the second or engaged position on the collet2342, the locking bearing180still permits rotation of the treatment catheter102because the inner bearing race186rotates relative to the outer bearing race188. More particularly, with the single tab of the second plurality of integral tabs2354which includes the pair of peaks2356and the valley2358formed therebetween wedged into a groove164of the locking interface160, the collet2342is mechanically interlocked with the locking interface160. When a user rotates the treatment catheter102(thus rotating the locking interface160attached thereto), the assembly of the collet2342and the inner bearing race186rotates therewith. Although the locking bearing180is radially compressing the midportion of the collet2342, the locking bearing180still permits rotation of the collet since the locking bearing180is a ball bearing. The inner bearing race186and balls190rotate with the collet2342, while outer bearing race188stays stationary.