Patent Description:
Diseased or otherwise deficient heart valves can be repaired or replaced with an implanted prosthetic heart valve. Conventionally, heart valve replacement surgery is an open-heart procedure conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. Traditional open surgery inflicts significant patient trauma and discomfort, and exposes the patient to a number of potential risks, such as infection, stroke, renal failure, and adverse effects associated with the use of the heart-lung bypass machine, for example.

Due to the drawbacks of open-heart surgical procedures, there has been an increased interest in minimally invasive and percutaneous replacement of cardiac valves. With percutaneous transcatheter (or transluminal) techniques, a prosthetic heart valve is compacted for delivery in a catheter and then advanced, for example, through an opening in the femoral artery and through the descending aorta to the heart, where the prosthetic heart valve is then deployed in the annulus of the valve to be restored (e.g., the aortic valve annulus). Although transcatheter techniques have attained widespread acceptance with respect to the delivery of conventional stents to restore vessel patency, only mixed results have been realized with percutaneous delivery of the more complex prosthetic heart valve.

The present disclosure provides improvements relating to transcatheter delivery devices. <CIT> describes a guidewire adjuster and delivery-system control handle. <CIT> describes a control module for delivery systems.

The techniques of this disclosure generally relate to delivery devices for transcatheter delivery of a prosthesis. The delivery device includes a hollow shaft on which the prosthesis is supported. A handle assembly maintains the shaft. The delivery device further includes a guide wire that is selectively directed through the handle assembly and shaft. The guide wire directs the shaft to a target site at which the prosthesis is to be deployed. In practice, an operator managing the shaft or inner catheter controls the prosthesis positioning. The delivery devices disclosed herein are configured to ergonomically also allow the operator to control the position of the guide wire as the position of the guide wire influences the deployment position of the prosthesis. In this way, a second operator for positioning the guide wire can be omitted. Embodiments of the disclosure are believed to improve positioning predictability and ease of use.

The invention is directed to a delivery device according to independent claim <NUM>.

In an example (not claimed), the disclosure provides methods of controlling a guide wire. The method can include providing a delivery device having a handle assembly with a distal end and a proximal end. The handle assembly further including a body defining a lumen that extends from the distal end to the proximal end. The delivery device further includes a hollow shaft extending from the distal end of the handle assembly and a guide wire control. The guide wire control includes an actuator positioned at the distal end of the handle assembly and a lock positioned at the proximal end of the handle assembly. The actuator being interconnected to the lock with a connector positioned within the lumen. In this example, the guide wire control is provided in an unlocked state. The method further includes positioning a guide wire through the lumen and directing the guide wire through the lumen and into a vasculature of a patient proximate a target site by movement of the actuator. The method also includes transitioning the lock to the locked state.

Specific embodiments of the present disclosure 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. Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the scope of the present disclosure.

<FIG> illustrates two clinicians C1, C2 utilizing a delivery device <NUM> to deliver a prosthesis via a transcatehter procedure. The delivery device <NUM> can be of any known in the art that includes a handle assembly <NUM> connected to a hollow shaft <NUM> or the like on which the prosthesis (not visible) is supported. A guide wire <NUM> is provided and can be extended through the handle assembly <NUM> and shaft <NUM>. In one example, the prosthesis is supported on the shaft <NUM> and an outer catheter (not shown) is provided to selectively sheathe the shaft <NUM> and prosthesis. The prosthesis could be one of a number of prosthesis such as a stent, prosthetic heart valve, for example. In such a procedure, the first clinician C1 manages and controls the shaft <NUM> and outer catheter management. For example, the first operator C1 controls a depth of the shaft (and optional outer catheter) during prosthesis deployment. A second operator C2 directs a guide wire <NUM> through a proximal end of a handle assembly <NUM> of the device to a distal end of the device <NUM>, through the patient's vasculature to a target site. The second clinician C2 uses the guide wire for fine adjustment of the shaft/optional outer catheter and tension adjustment. It has been observed that with use of such delivery devices, the first operator C <NUM> usually holds onto the shaft <NUM> or outer catheter with one hand and reaches with an underhanded grip to the guide wire <NUM>. Then, the first operator C1 reaches over the second clinician C2 to move the guide wire <NUM>, which is ergonomically awkward. Optionally, a third clinician C3 is provided to retract an outer catheter, if provided.

<FIG> collectively illustrate a delivery device <NUM> for transcatheter delivery of a prosthesis <NUM>. The delivery device <NUM> includes a hollow shaft <NUM> on which the prosthesis <NUM> is supported. It is noted that in <FIG> the shaft <NUM> is not shown to scale and shaft <NUM> is shown as foreshortened for ease of illustration. The shaft <NUM> may be significantly longer in practice. The delivery device <NUM> can further include an outer catheter (not shown) selectively sheathing the shaft <NUM> and prosthesis <NUM> during delivery. A handle assembly <NUM> maintains the shaft <NUM> and outer catheter. In some embodiments, the handle assembly <NUM> is configured to allow an operator to control movement of the outer catheter with respect to the shaft <NUM>. The handle assembly <NUM> includes a body <NUM> having a distal and proximal end <NUM>, <NUM>. The body <NUM> defines an interior lumen <NUM> extending through the proximal end <NUM> and through the distal end <NUM>. The delivery device <NUM> further includes a guide wire <NUM> that is selectively directed through the lumen <NUM> of the handle assembly <NUM> and through the shaft <NUM>. It is envisioned that the guide wire <NUM> can be provided separate from the delivery device <NUM>. The guide wire <NUM> is threaded through the hollow shaft <NUM> to direct the prosthesis <NUM> to a target site at which the prosthesis <NUM> is to be deployed. In practice, an operator managing the shaft <NUM> controls the prosthesis <NUM> positioning. The delivery devices disclosed herein are configured to ergonomically also allow the operator to control the position of the guide wire as the position of the guide wire influences the deployment position of the prosthesis. In this way, a second operator for positioning the guide wire can be omitted. Embodiments of the disclosure are believed to improve positioning predictability and ease of use.

The delivery device <NUM> includes a guide wire control <NUM> including an actuator <NUM> at the distal end <NUM> of the body <NUM> of the handle assembly <NUM>. In some embodiments, the actuator <NUM> is positioned on the shaft <NUM>. The actuator <NUM> is configured to control advancement of the guide wire <NUM>. In one example, the actuator <NUM> has thumbwheel <NUM> secured to a slider <NUM> (schematically shown) that engages and advances the guide wire <NUM> routed through an opening or lumen <NUM> in the slider <NUM>. One embodiment of this would be utilization of a rack and pinion mechanism where the thumbwheel <NUM> is the diving pinion and the rack is attached to the guide wire <NUM>. Any other actuator capable of advancing the guide wire <NUM> and connection to the connector <NUM> is suitable.

The guide wire control <NUM> further includes a connector <NUM> extending through the lumen <NUM> of the body <NUM> and interconnecting the actuator <NUM> to a lock <NUM> that is positioned at a proximal end <NUM> of the body <NUM>. The connector <NUM> can be welded or otherwise secured to both the actuator <NUM> and the lock <NUM>. In one embodiment, the lock <NUM> is mounted to one or more support rods <NUM> extending from the proximal end <NUM>. In various embodiments, the connector <NUM> includes a lumen <NUM> through which the guide wire <NUM> is routed. In such embodiments, the lumen <NUM> of the connector <NUM> is coaxial with the lumen <NUM> of the actuator/slider <NUM>. In one embodiment, the connector <NUM> is not hollow but is a rod (i.e. stiff wire or rigid shaft) and the guide wire <NUM> is routed parallel to and spaced from the connector <NUM>. Movement of the actuator <NUM> back and forth, via the thumbwheel <NUM> or the like correspondingly pulls and pushes the lock <NUM> and connector <NUM> with respect to the body <NUM> of the handle assembly <NUM> when the lock <NUM> is in the unlocked state.

The lock <NUM> includes a lumen or opening <NUM> through which the guide wire <NUM> is routed and is configured to have an unlocked state in which the guide wire <NUM> can move longitudinally through both the lumens <NUM>, <NUM>, <NUM> of the lock <NUM>, the body <NUM> and slider <NUM>. The lock <NUM> is further configured to have a locked state in which the guide wire <NUM> is locked and maintained in longitudinal position with respect to both the handle assembly <NUM> and the shaft <NUM>. In one example of use, the lock <NUM> is left in its unlocked state until the shaft <NUM> is tracked and in its initial position, proximate a target site. The guide wire <NUM> is then locked with the lock <NUM> allowing an operator to take over from the patient side (i.e. distal end <NUM> of the handle assembly <NUM>) allowing for single operator positioning control during prosthesis deployment. In one example, the lock <NUM> can be a Tuohy Borst type connector.

The devices (e.g., delivery device <NUM>) of the disclosure can be used in methods of controlling a guide wire <NUM>. The method can include providing the delivery device <NUM>. The prosthesis <NUM>, such as a stent or prosthetic heart valve, for example, can be provided on or collapsed onto the shaft <NUM>. In this example, the guide wire control <NUM> is provided in the unlocked state. The method further includes positioning the guide wire <NUM> through the lumens <NUM>, <NUM>, <NUM> of the lock <NUM>, handle assembly <NUM> and actuator <NUM> and directing the guide wire <NUM> into a vasculature of a patient proximate a target site by movement or other actuation of the actuator <NUM>. In one example where the connector <NUM> includes a lumen <NUM>, the guide wire <NUM> can also be routed through the connector <NUM>. The shaft <NUM> is advanced along the guide wire <NUM> until the prosthesis <NUM> is guided to the target site for deployment. The method also includes transitioning the lock <NUM> to the locked state so that the longitudinal position of the guide wire <NUM> is maintained with respect to the handle assembly <NUM> and the shaft <NUM> during shaft/prosthesis <NUM>/<NUM> positioning and prosthesis <NUM> deployment.

Claim 1:
A delivery device (<NUM>) comprising:
a handle assembly (<NUM>) having a distal end (<NUM>) and a proximal end (<NUM>), the handle assembly further including a body (<NUM>) defining a lumen (<NUM>) that extends from the distal end to the proximal end;
a hollow shaft (<NUM>) extending from the distal end of the handle assembly;
a guide wire (<NUM>) extending through the lumen; and
a guide wire control (<NUM>); the guide wire control including an actuator (<NUM>) positioned at the distal end of the handle assembly and a lock (<NUM>) positioned at the proximal end of the handle assembly, the actuator interconnected to the lock with a connector (<NUM>) positioned within the lumen; wherein the guide wire control has an unlocked state, in which the guide wire (<NUM>) can move longitudinally through the lumen (<NUM>) of the body (<NUM>) and through a lumen (<NUM>) of the lock (<NUM>), and the guide wire control further having a locked state in which the guide wire (<NUM>) is locked with the lock (<NUM>) and in which the actuator is configured to control advancement of the guide wire (<NUM>).