Systems, devices, and methods for generating shock waves in a forward direction

Inventors

Hasenberg, Thomas Charles • Betelia, Rainier • Lang, Michael • FRANCO, Jason B. • Zelenka, Robert • Ho, Thu Anh • Jenkins, Todd Weston • HUDON, Andrew James

Assignees

Shockwave Medical Inc

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Publication Number

US-12402899-B2

Patent

Publication Date

2025-09-02

Expiration Date


Abstract

An exemplary catheter for use in a body lumen comprises: a catheter body; and a plurality of shock wave emitters disposed at a distal end of the catheter body, each shock wave emitter configured to generate a shock wave that propagates distally of the catheter body, wherein the plurality of shock wave emitters are arrayed about a longitudinal axis of the catheter body such that shock waves emitted from the plurality of shock wave emitters can constructively interfere distally of the catheter body, and wherein each shock wave emitter comprises electrodes separated by a spark gap and at least one electrical connector that connects at least one of the electrodes to an electrode of another shock wave emitter of the plurality of shock wave emitters.

Core Innovation

The invention relates to a catheter for use in a body lumen having a catheter body and a plurality of shock wave emitters disposed at a distal end. Each shock wave emitter is configured to generate a shock wave that propagates distally of the catheter body, and at least one shock wave emitter includes electrodes separated by a spark gap and at least one electrical connection to an electrode of at least one other shock wave emitter, enabling coordinated shock-wave generation from a distal array.

The distal shock wave emitters include an emitter outermost surface positioned externally relative to an outer circumferential surface of the catheter body, or a distal-most surface that is flush with, or forward of, the distal-most surface of the distal end of the catheter body. The plurality of emitters is arranged so emitted shock waves can constructively interfere distally of the catheter body, including emitter spacing between 1 mm and 10 mm and arrangements having symmetry or asymmetry and corresponding axial positioning.

The invention further includes electrical connection configurations between electrodes of different shock wave emitters and operating arrangements such as series electrical connection, and optionally independent driving of emitters. An enclosure at the distal end, together with conductive fluid within the enclosure, is described as a way to control cavitation and thermal effects, and a central lumen and/or aspiration lumen may be provided for catheter functions in conjunction with the distal emitter array.

In medical use, the invention is directed to applying distal-propagating shock waves to break up target tissue so that a pacemaker lead can be removed, including fibrotic tissue at a target site. The disclosed shock-wave emission includes breaking up fibrotic tissue at a target site in the heart and optionally generating radially propagating shock waves to at least partially break up a calcified region of vasculature leading to a target site.

Claims Coverage

The partial content includes four independent claims, covering a distal array catheter with spark-gap electrode emitters and electrical connections, constructive distal interference variants, and a pacemaker-lead removal method using distal shock waves.

Externally positioned spark-gap shock-wave emitter array

A catheter comprising a catheter body and a plurality of shock wave emitters disposed at a distal end, each configured to generate a shock wave that propagates distally of the catheter body, wherein at least one shock wave emitter comprises electrodes separated by a spark gap and at least one electrical connection to an electrode of at least one other shock wave emitter, and wherein an outermost surface of a shock wave emitter is positioned externally relative to an outer circumferential surface of the catheter body.

Flush distal-most spark-gap emitter with electrical connections

A catheter for use in a body lumen comprising a catheter body and a plurality of shock wave emitters disposed at a distal end, each configured to generate a shock wave that propagates distally of the catheter body, wherein at least one shock wave emitter comprises electrodes separated by a spark gap, wherein a distal most surface of a shock wave emitter is flush with a distal most surface of the distal end of the catheter body, and at least one electrical connection to an electrode of at least one other shock wave emitter.

Forward positioned spark-gap emitter array

A catheter for use in a body lumen comprising a catheter body and a plurality of shock wave emitters disposed at a distal end, each configured to generate a shock wave that propagates distally of the catheter body, wherein at least one shock wave emitter comprises electrodes separated by a spark gap, wherein a distal most surface of a shock wave emitter is positioned forward of a distal most surface of the distal end of the catheter body, and at least one electrical connection to an electrode of at least one other shock wave emitter.

Pacemaker lead removal using distal shock-wave break-up of fibrotic tissue

A method for removing a pacemaker lead comprising advancing a catheter along the pacemaker lead to a target site comprising fibrotic tissue, the catheter having a catheter body and a plurality of shock wave emitters disposed at a distal end configured to generate shock waves that propagate distally, including at least one shock wave emitter with electrodes separated by a spark gap and at least one electrical connection to an electrode of at least one other shock wave emitter, and generating one or more shock waves to at least partially break up the fibrotic tissue so that the pacemaker lead can be removed.

Overall, the claim set in the partial content focuses on distal shock-wave emitter catheter embodiments where spark-gap electrode emitters are electrically connected within a distal array, with structural variations in how emitter surfaces are externally positioned and with wave-arrangement and electrical-connection variants. The method coverage uses the same distal shock-wave catheter to break up fibrotic tissue at a target site to enable pacemaker lead removal.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Removing a pacemaker lead by breaking up fibrotic tissue at a target site using one or more distally propagating shock waves.

Breaking up a calcified region of vasculature leading to a target site using radially propagating shock waves.

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