Lesion crossing shock wave catheter
Inventors
Phan, Huy • Nguyen, Hoa • Long, Chi • Jenkins, Todd
Assignees
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Publication Number
US-12232755-B2
Publication Date
2025-02-25
Expiration Date
Abstract
The present invention provides a catheter for treating occlusions in blood vessels. An exemplary catheter for treating occlusions in blood vessels comprises a tubular inner member including a base segment with a first lumen defining a fluid inlet port, and a second lumen defining a fluid outlet port. An extension segment is distal to the base segment. The extension segment has a reduced cross-section. An emitter assembly includes a first insulated wire extending through the second lumen and a second insulated wire, and a conductive sheath wrapped circumferentially around the first insulated wire, the second insulated wire, and the extension segment. A cap or balloon is sealably attached to the distal end of the catheter and surrounds the emitter assembly, said cap or balloon being fillable with conductive fluid.
Core Innovation
The invention relates to a low-profile intravascular shock wave catheter for treating occlusions in blood vessels, including calcified lesions and occlusions. The catheter is configured to cross such occlusions while carrying a bipolar shock-wave emitter assembly located within a flexible cap or angioplasty balloon. The distal catheter region has a reduced cross-section extension segment, optionally sized to receive a guidewire.
A bipolar electrical circuit is implemented using coplanar or low-profile electrode pairs formed by insulated wires and a circumferential conductive sheath. The conductive sheath defines two electrode pairs, and the design includes controlled wire-to-sheath gaps that are positioned to create an arc/plasma region at the gaps to generate shock waves. The insulation and conductive elements are arranged so the electrodes are radially inside the distal ends of the first and second wires and surrounded by a cylindrical insulation sheath.
To maintain the space around the electrodes and manage bubbles and debris, the catheter includes conductive fluid inlet/outlet lumens that enable flushing of the space around the electrodes during use. The cap or angioplasty balloon is sealably attached to the catheter, maintained in a non-folded low-profile configuration prior to insertion, and elastomeric or semi-compliant so it returns to a low profile after deflation. During operation, conductive fluid is used to immerse the electrodes, and pulsed high voltage is applied to generate first and second shock waves at the electrode pairs while flushing during the pulses.
The description also covers structural alternatives for the distal section, including multiple lumens (tri-lumen, quad-lumen, or quin-lumen) for inner members, a single-extrusion inner member with flutes, and configurations that define a return path for conductive fluid. Additional mechanical features include a reinforced braided wire sheath, an optional plastic liner, a soft atraumatic distal tip, and alternative sheath geometries such as a cylindrical or flattened circumferential conductive sheath.
Claims Coverage
The independent claim is clm-00001. It defines a catheter construction for treating occlusions in blood vessels with a tubular inner member, a bipolar electrode structure, and a flexible cap over the conductive and distal tip region, while also defining a conductive-fluid delivery/return structure. The listed dependent claims narrow construction details and specify functional relationships for shock-wave generation and conductive-fluid return connectivity.
Tubular inner member with circumferential flutes and four tubes
A catheter with a tubular inner member whose proximal portion has a first diameter and whose distal end portion has a second diameter smaller than the first diameter, with the proximal portion including four circumferentially positioned flutes, each flute receiving one of four tubes; the third tube is connectable to a source of conductive fluid, and the fourth tube is configured to define a return path for the conductive fluid, while first and second wires extend distally beyond their respective first and second tubes.
Cylindrical insulation sheath and cylindrical conductive sheath forming two electrode pairs
A cylindrical insulation sheath positioned around the distal portion of the inner member and radially inside the distal ends of the first and second wires, and a cylindrical conductive sheath surrounding the distal ends of the first and second wires and defining two electrode pairs.
Flexible cap surrounding the conductive sheath and distal tip
A sheath surrounding the proximal portion of the inner member and a flexible cap surrounding the conductive sheath and a distal tip of the catheter.
Voltage-triggered generation of two shock waves at uninsulated wire-to-sheath gaps
When voltage is applied to proximal ends of the first and second wires, current jumps each uninsulated wire-to-sheath gap to generate a first shock wave at the first gap and a second shock wave at the second gap.
Uninsulated wire-to-sheath gap for a first wire adjacent to the cylindrical conductive sheath
A distal end of the first wire is uninsulated and spaced from the cylindrical conductive sheath by a first gap.
Return path via a tube connectable to a source of conductive fluid or suction
The catheter includes a fourth tube connectable to a source of conductive fluid, and a fourth tube connectable to a source of suction, configured for the return/fluids pathway as described in the claim set.
Single-extrusion inner member
The catheter where the inner member is formed from a single extrusion.
Insulation sheath geometry with constant-diameter distal portion and tapered proximal portion
A cylindrical insulation sheath with a distal portion of constant diameter and a proximal portion that is tapered.
Overall, the claim coverage centers on a tubular inner member with flutes and four tubes (including conductive-fluid delivery and return path), a distal electrode region with a cylindrical insulation sheath and a cylindrical conductive sheath forming two electrode pairs, and a flexible cap over the distal region. Dependent claims further refine the inner-member construction (single extrusion), insulation-sheath geometry, and specify uninsulated wire-to-sheath gaps and how applying voltage generates first and second shock waves. The claim set also includes options for connecting the return/fluids pathway to a source of conductive fluid or suction as stated.
Stated Advantages
Documented Applications
Treating occlusions in blood vessels, including calcified lesions and occlusions.
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