Intravascular lithotripsy catheter with oscillating impactor

Inventors

Nguyen, Hoa D.Stephens, Patrick

Assignees

Shockwave Medical Inc

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Publication Number

US-12426904-B2

Patent

Publication Date

2025-09-30

Expiration Date


Abstract

Catheter devices for treating occlusions in body lumen are described herein. The catheter devices may include a tubular body having a distal end, an distal portion elastically connected to the distal end of the tubular body, an impactor connected to the distal portion and separated by a space from the distal end of the tubular body, a distal shock wave emitter located adjacent to the space and connected to a power source, and an enclosure at least partially surrounding each of the distal end of the tubular body, the elastic distal portion, the impactor, and the distal shock wave emitter. The impactor may be configured to move in response to shock waves generated from the distal shock wave emitter, such that a length of the space in the proximal-distal direction increases by between 0.05 mm and 0.6 mm.

Core Innovation

The invention relates to an intravascular lithotripsy catheter for treating an occlusion in a body lumen by producing one or more shock waves. A tubular body includes a distal portion configured to move relative to a proximal portion, and an impactor is mounted on, and at least partially encircling, the distal portion. A voltage source applies a voltage pulse to a conductor so that current flows across a gap between the conductor and a conductive portion of the impactor, and this current generates one or more shock waves that cause the impactor to move in a distal direction.

The catheter architecture separates the impactor from the distal end by a space and positions a distal shock-wave emitter adjacent to the space. Shock waves generated at the distal shock-wave emitter drive movement of the impactor in a distal direction, producing an oscillating jackhammer effect in which the impactor chisel/penetrates resistant calcified fibrotic tissue to form a tunnel. An enclosure at least partially surrounds the distal end, the elastic distal portion, the impactor, and the distal shock wave emitter, and permits length change to accommodate impactor motion while maintaining shock-wave generation and propagation.

The enclosure is configured so that the length of the space in the proximal-distal direction increases by between 0.05 mm and 0.6 mm in response to shock-wave-driven impactor movement. In related catheter configurations, a shock wave emitter is located on or proximate the tubular body, and the enclosure surrounding the shock wave emitter includes a proximal region that expands in the distal-proximal direction in conjunction with distal movement of the impactor and contracts in the distal-proximal direction in conjunction with proximal movement of the impactor.

Claims Coverage

The independent claims identified are clm-00001, clm-00022, and clm-00023. Across these independent claims, the coverage centers on electrically generating shock waves via a conductor-to-conductive-portion gap and driving impactor motion, and on structural enclosure arrangements that accommodate and quantify proximal-distal space changes in response to shock-wave operation.

Voltage-pulse-driven shock waves across a conductor-to-impactor gap

A catheter including a conductor configured to receive a voltage pulse; an impactor mounted on, and at least partially encircling, a distal portion and having a conductive portion adjacent to a distal end of the conductor; wherein current flows across a gap between the conductor and the conductive portion when the voltage pulse is applied to generate one or more shock waves that cause the impactor to move in a distal direction.

Elastically connected distal portion with enclosure-defined space increase

A catheter with a tubular body distal end; a distal portion elastically connected to the distal end; an impactor connected to, and at least partially encircling, the distal portion and separated by a space from the distal end; a distal shock wave emitter located adjacent to the space; and an enclosure at least partially surrounding each of the distal end, the elastic distal portion, the impactor, and the distal shock wave emitter; wherein the impactor moves in response to a shock wave from the distal shock wave emitter such that a length of the space in a proximal-distal direction increases by between 0.05 mm and 0.6 mm.

Shock-wave emitter and enclosure proximal region that expands and contracts with impactor motion

A catheter with a tubular body comprising a distal end; a distal portion elastically connected to the distal end; an impactor connected to, and at least partially encircling, the distal portion and configured to move in a distal-proximal direction; a shock wave emitter located on or proximate the tubular body; and an enclosure surrounding the shock wave emitter including a proximal region configured to expand in the distal-proximal direction in conjunction with distal movement of the impactor and contract in the distal-proximal direction in conjunction with proximal movement of the impactor.

The independent claim set collectively covers an intravascular lithotripsy catheter where a voltage pulse drives shock-wave generation using current across a gap to move a conductive impactor, and where an enclosure surrounds the distal end, emitter, and impactor and accommodates impactor motion, including quantified proximal-distal space increase and enclosure proximal region expansion and contraction tied to impactor motion.

Stated Advantages

Generates one or more shock waves that cause the impactor to move in a distal direction.

Drives impactor movement in response to a shock wave generated from a distal shock wave emitter such that the proximal-distal length of a space increases by between 0.05 mm and 0.6 mm.

Provides an enclosure configuration with a proximal region that expands and contracts in conjunction with distal and proximal movement of the impactor.

Enables an oscillating jackhammer effect to chisel/penetrate resistant calcified fibrotic tissue to form a tunnel.

Documented Applications

Treating an occlusion in a body lumen, including intravascular occlusions such as coronary chronic total occlusions (CTOs).

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