News Column

"Shockwave Catheter" in Patent Application Approval Process

July 3, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- A patent application by the inventors HAWKINS, Daniel (Pleasanton, CA); ADAMS, John M. (Snohomish, WA), filed on August 1, 2013, was made available online on June 19, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents.

This patent application is assigned to Shockwave Medical, Inc.

The following quote was obtained by the news editors from the background information supplied by the inventors: "Patients suffering from aortic valve stenosis often have calcified aortic valve leaflets. Shockwave therapy for the treatment of aortic valve stenosis has been previously described in, for example U.S. Pat. Pub. No. 2010/0114020A1, the disclosure of which is incorporated herein by reference. As described therein, a valvuloplasty catheter includes a balloon that is inflatable with a fluid. When the balloon is inflated, it is configured to be adjacent valve leaflets, such as the valve leaflets of an aortic valve. Within the balloon, there is disposed a shock wave generator. The shock wave generator includes at least two electrodes. When a high voltage pulse is applied across the electrodes, an electrical arc is formed. The electrical arc creates a shock wave within the fluid that propagates to the balloon walls to impinge upon the valve leaflets and the calcification on the valve. Repeated shock waves cause the calcification to break-up.

"The distance between the shock wave generator (the electrodes) and the valve leaflets of the catheter described above is variable and not controlled. It has been found that shock wave therapy designed to break calcium deposits is most effective at certain distances from a radiating shock wave source. This is particularly the case when the source is a point source without a reflector. Generally, the effectiveness of the shock waves falls off or decreases with the square of the distance from the source.

"When a valvuloplasty balloon and a shock wave generator are combined as described above, the distance between the shock wave generator and the balloon walls generally increases as the valve is opened by balloon expansion occasioned by effective treatment and valvuloplasty pressure. As the distance changes and becomes greater, the effectiveness of the therapy decreases. This increases both the time and the number of shock waves required for complete and effective treatment. Hence, there is a need for a shock wave valvuloplasty catheter that maintains therapy effectiveness at a desired level until the valve being treated is dilated the desired amount."

In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventors' summary information for this patent application: "According to embodiments shown and described herein, a catheter, which may find use, for example, in valvuloplasty, includes an elongated body and an inflatable balloon carried by the elongated body. The balloon has an inner surface and an outer surface. The catheter further includes at least one shock wave source within the inflatable balloon and a follower arrangement that maintains the at least one shock wave source a substantially fixed distance from the inner surface of the balloon.

"The follower arrangement may be carried by the at least one shock wave source within the inflatable balloon. The at least one shock wave source may be an arc generator including an electrode pair.

"The follower arrangement may include at least one stand-off extending from the electrode pair. The stand-off may be formed of flexible material.

"The arc generator may include an elongated lead. The electrode pair may be carried by the elongated lead, and the elongated lead may be biased in a direction towards the inner surface of the inflatable balloon. The elongated lead may include at least one bend that biases the elongated lead towards the inner surface of the inflatable balloon.

"The catheter may further include a biasing member carried by the elongated lead that biases the elongated lead towards the inner surface of the inflatable balloon. The biasing member may be a spring.

"The at least one shock wave source may include an arc generator. The follower arrangement may include a stand-off carried by the arc generator and the arc generator may be biased towards the inner surface of the inflatable balloon.

"The catheter may further include a frame structure that carries the at least one shock wave source. The frame structure may be arranged to expand with inflation of the inflatable balloon to maintain the at least one shock wave source a substantially fixed distance from the inner surface of the balloon. The frame structure may include at least one stand-off adjacent the at least one shock wave source to maintain the at least one shock wave source a substantially fixed distance from the inner surface of the balloon.

"In other embodiments, a method includes the steps of providing a catheter including an elongated body, an inflatable balloon carried by the elongated body and having an inner surface and an outer surface, and at least one shock wave source within the inflatable balloon. The method further includes the steps of inserting the catheter into a vein or artery of a patient and placing the balloon adjacent to an anatomical structure to be treated, inflating the balloon with a fluid, causing the shock wave source to provide shock waves within the balloon that propagate through the liquid to treat the anatomical structure, and maintaining the at least one shock wave source a substantially fixed distance from the inner surface of the balloon while the shock waves are provided by the at least one shock wave source.

"The catheter may further include a follower carried by the shock wave generator, and the maintaining step may include biasing the follower against the inner wall of the balloon.

"The catheter may include a frame structure that carries the at least one shock wave source. The maintaining step may include expanding the frame structure with inflation of the inflatable balloon to maintain the at least one shock wave source the substantially fixed distance from the inner surface of the balloon.

BRIEF DESCRIPTION OF THE DRAWINGS

"The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The various described embodiments of the invention, together with representative features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein:

"FIG. 1 is a partial cut away view of a heart and a catheter embodying aspects of the invention within the aortic valve of the heart;

"FIG. 2 is a side view of a shock wave generator which may be used to advantage within the catheter of FIG. 1 and which embodies aspects of the invention;

"FIG. 3 is a partial cut away view of the heart of FIG. 1 illustrating the catheter as it is delivering therapy to the aortic valve of the heart;

"FIG. 4 is a partial cut away view of the heart of FIG. 1 illustrating the catheter upon completion of therapy to the aortic valve of the heart;

"FIG. 5 is a partial cut away view of another heart and another catheter embodying further aspects of the invention within the aortic valve of the heart; and

"FIG. 6 is a partial view to an exploded scale illustrating particular aspects of the catheter of FIG. 5."

URL and more information on this patent application, see: HAWKINS, Daniel; ADAMS, John M. Shockwave Catheter. Filed August 1, 2013 and posted June 19, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1659&p=34&f=G&l=50&d=PG01&S1=20140612.PD.&OS=PD/20140612&RS=PD/20140612

Keywords for this news article include: Therapy, Stenosis, Angiology, Shockwave Medical Inc..

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Source: Politics & Government Week