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Researchers Submit Patent Application, "Preparation Methods for Transcatheter Heart Valve Delivery Systems", for Approval

August 7, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventor Wang, Huisun (Maple Grove, MN), filed on March 17, 2014, was made available online on July 24, 2014.

The patent's assignee is St. Jude Medical, Cardiology Division, Inc.

News editors obtained the following quote from the background information supplied by the inventors: "The present invention is related to prosthetic heart valve replacement, and more particularly to devices, systems, and methods for transcatheter delivery of collapsible prosthetic heart valves.

"Prosthetic heart valves that are collapsible to a relatively small circumferential size can be delivered into a patient less invasively than valves that are not collapsible. For example, a collapsible valve may be delivered into a patient via a tube-like delivery apparatus such as a catheter, a trocar, a laparoscopic instrument, or the like. This collapsibility can avoid the need for a more invasive procedure such as full open-chest, open-heart surgery.

"Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent. There are two types of stents on which the valves structures are ordinarily mounted: a self-expanding stent and a balloon-expandable stent. To place such valves into a delivery apparatus and ultimately into a patient, the valve must first be collapsed or crimped to reduce its circumferential size.

"When a collapsed prosthetic valve has reached the desired implant site in the patient (e.g., at or near the annulus of the patient's heart valve that is to be replaced by the prosthetic valve), the prosthetic valve can be deployed or released from the delivery apparatus and re-expanded to full operating size. For balloon-expandable valves, this generally involves releasing the entire valve, assuring its proper location, and then expanding a balloon positioned within the valve stent. For self-expanding valves, on the other hand, the stent automatically begins to expand as the sheath covering the valve is withdrawn. Once a self-expanding valve has been fully deployed, it expands to a diameter larger than that of the sheath that previously retained the valve in the collapsed condition.

"Despite the various improvements that have been made to the collapsible prosthetic heart valve delivery process, conventional delivery devices, systems, and methods suffer from some shortcomings. There therefore is a need for further improvements to the devices, systems, and methods for transcatheter delivery of collapsible prosthetic heart valves."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventor's summary information for this patent application: "A delivery device for a collapsible prosthetic heart valve, a delivery system for a collapsible prosthetic heart valve, and a method of flushing a delivery device for a collapsible prosthetic heart valve are disclosed.

"A delivery device for a collapsible prosthetic heart valve includes a support shaft around which a compartment is defined, the compartment being adapted to receive the valve in an assembled condition, an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, the inner shaft having a lumen therethrough, a distal sheath operatively connected at a distal end to the inner shaft and slidable therewith, the distal sheath being adapted to selectively cover and uncover the compartment and the valve, and a first flow path providing flow communication between the lumen of the inner shaft and the compartment.

"The delivery device may also include a distal tip operatively connected to a distal end of the inner shaft, a distal retainer interposed between the distal tip and the compartment, and a pocket defined between the distal retainer and the distal tip. The delivery device may also include a second flow path providing flow communication between the pocket and the compartment. The second flow path may include at least one through-hole in the distal retainer. The first flow path may include an aperture in a wall of the inner shaft providing flow communication between the lumen of the inner shaft and the pocket. The delivery device may also include an insert disposed in the pocket and defining an empty space between the insert and the distal tip, the empty space being in flow communication with the lumen of the inner shaft, the insert including one or more liquid passages extending between the empty space and the pocket. The delivery device may also include a proximal retainer located at a proximal end of the compartment, and a cylindrical gap defined between a free end of the distal sheath and the proximal retainer.

"A delivery device for a collapsible prosthetic heart valve includes a support shaft around which a compartment is defined, the compartment being adapted to receive the valve in an assembled condition, an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, the inner shaft having a lumen therethrough, a distal sheath having a distal end operatively connected to the inner shaft and slidable therewith, the distal sheath being adapted to selectively cover and uncover the compartment and the valve, and a distal tip operatively connected to a distal end of the inner shaft, the distal tip having a passage therein providing flow communication between an exterior of the delivery device and the compartment. The passage may be adapted to self-seal such that liquid can not flow therethrough from the compartment to the exterior of the delivery device.

"A delivery system for a collapsible prosthetic heart valve includes a support shaft around which a compartment is defined, the compartment being adapted to receive the valve in an assembled condition, an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, the inner shaft having a lumen therethrough in flow communication with an exterior of the delivery device, a distal sheath operatively connected at a distal end to the inner shaft and slidable therewith, the distal sheath being adapted to selectively cover and uncover the compartment and the valve, a first flow path providing flow communication between the lumen of the inner shaft and the compartment, and a removable plug adapted for connection to the delivery device to occlude the flow communication between the lumen of the inner shaft and the exterior of the delivery device.

"The delivery system may also include a removable cap adapted for connection to a proximal end of the inner shaft to create a liquid-tight seal at the proximal end of the inner shaft. The delivery system may also include a distal tip operatively connected to a distal end of the inner shaft, and a flushing needle having a hollow needle shaft adapted to supply a flushing liquid to the compartment through the distal tip. The delivery system may also include a distal tip operatively connected to a distal end of the inner shaft, a distal retainer interposed between the distal tip and the compartment, and a pocket defined between the distal retainer and the distal tip. The delivery system may also include a second flow path providing flow communication between the pocket and the compartment. The second flow path may include at least one through-hole in the distal retainer. The first flow path may include an aperture in a wall of the inner shaft providing flow communication between the lumen of the inner shaft and the pocket. The delivery device may also include an insert disposed in the pocket and defining an empty space between the insert and the distal tip, the empty space being in flow communication with the lumen of the inner shaft, the insert including one or more liquid passages extending between the empty space and the pocket.

"A method of flushing a delivery device for a collapsible prosthetic heart valve may include providing a delivery device including a support shaft around which a compartment is defined, an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, and a distal sheath having a distal end operatively connected to the inner shaft and a proximal end, the distal sheath being slidable with the inner shaft, mounting a collapsible prosthetic heart valve in the compartment, sliding the distal sheath to cover the compartment and the valve, and flushing a liquid through the compartment from a distal end of the compartment to a proximal end of the compartment.

"The flushing step may include flowing the liquid out of the compartment through an opening at the proximal end of the distal sheath. The flushing step may include flowing the liquid through a lumen in the inner shaft in a direction from a proximal end of the inner shaft toward a distal end of the inner shaft, and flowing the liquid from the lumen of the inner shaft to the compartment. The flushing step may include flowing the liquid from the lumen of the inner shaft to the compartment through an aperture in a wall of the inner shaft. The delivery device may also include a distal tip operatively connected to the distal end of the inner shaft, a distal retainer interposed between the distal tip and the compartment, a pocket defined between the distal retainer and the distal tip, and an insert disposed in the pocket and defining an empty space between the insert and the distal tip. The flushing step may include flowing the liquid from the lumen of the inner shaft to the empty space, from the empty space through the insert to the pocket, and from the pocket through the distal retainer to the compartment. The flushing step may include flowing the liquid through a lumen in the inner shaft in a direction from a distal end of the inner shaft toward a proximal end of the inner shaft, and flowing the liquid from the lumen of the inner shaft to the compartment. The delivery device may also include a distal tip operatively connected to a distal end of the inner shaft, the distal tip having a passage therein. The flushing step may include flowing the liquid through the passage into the distal end of the compartment.

BRIEF DESCRIPTION OF THE DRAWINGS

"Various embodiments of the present invention will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only some embodiments of the invention and are therefore not to be considered limiting of its scope.

"FIG. 1 is a highly schematic side elevational view of a transapical delivery device for a collapsible prosthetic heart valve according to an embodiment of the invention, shown in partial cross-section and illustrating an exemplary flow of flushing liquid through the device;

"FIG. 2 is an enlarged partial cross-sectional view of a liquid communication assembly suitable for use in the delivery device of FIG. 1;

"FIG. 3 is a highly schematic side elevational view of a transapical delivery device for a collapsible prosthetic heart valve according to another embodiment of the present invention, shown in partial cross-section with a flushing needle; and

"FIG. 4 is a highly schematic side elevational view of a transapical delivery device for a collapsible prosthetic heart valve according to a further embodiment of the present invention, shown in partial cross-section with a flushing needle."

For additional information on this patent application, see: Wang, Huisun. Preparation Methods for Transcatheter Heart Valve Delivery Systems. Filed March 17, 2014 and posted July 24, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=5127&p=103&f=G&l=50&d=PG01&S1=20140717.PD.&OS=PD/20140717&RS=PD/20140717

Keywords for this news article include: St. Jude Medical Cardiology Division Inc.

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Source: Politics & Government Week


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