Lesion crossing shock wave catheter
The present invention provides a catheter for treating occlusions in blood vessels. The catheter includes at least one electrode pair positioned inside of a flexible angioplasty balloon at the distal end of the catheter. In some designs, the electrode pairs are arranged in a low-profile or coplanar configuration, reducing the diameter of the distal end of the device and permitting treatment of tight and hard-to-cross occlusions. The flexible angioplasty balloon has an extremely low profile and does need to be folded before insertion of the catheter into the cardiovascular system. During treatment, the balloon can be expanded a relatively small amount sufficient to immerse the electrode pairs in a conductive fluid before generating shock waves across the electrodes to treat the occlusion. The balloon can be made of material having elastomeric properties such that it returns to its original low profile configuration when it is deflated following treatment.
1 . A catheter for treating occlusions in blood vessels comprising:
a tubular guidewire sheath defining a first lumen for receiving a guidewire and a second lumen;
a shock wave generator located near a distal end of the catheter, said shock wave generator including at least one electrode pair, with electrodes of the at least one electrode pair being spaced apart to define at least one gap;
a first wire extending within the second lumen, with a proximal end of the first wire being connectable to a pulsed voltage source and with a distal end of the first wire being connected to a first electrode of the at least one electrode pair;
a reinforced wire sheath wrapped circumferentially around the tubular guidewire sheath, wherein a proximal end of the reinforced wire sheath is connectable to the pulsed voltage source and a distal end of the reinforced wire sheath is connected to a second electrode of the at least one electrode pair;
a distal tip positioned at the distal end of the catheter, the distal tip including a lumen for receiving the guidewire; and
a cap having a distal end sealably attached to the distal tip and a proximal end sealably attached to the tubular guidewire sheath, the cap surrounding the at least one electrode pair to define a chamber fillable with conductive fluid, wherein when the chamber is filled with the conductive fluid and high voltage pulses are applied across the reinforced wire sheath and the first wire, current flows across the at least one gap creating shock waves for treating an occlusion.
2 . The catheter of claim 1 , wherein the cap is flexible and can be expanded by inflation with the conductive fluid and wherein a maximum inflated diameter of the cap is no more than 15% greater than a deflated diameter of the cap.
3 . The catheter of claim 1 , wherein the cap is made of material having elastomeric properties such that, after being inflated, the cap returns to a low profile configuration when deflated.
4 . The catheter of claim 1 , wherein the at least one electrode pair comprises a first electrode pair, the first electrode pair comprising:
an insulation removed portion of the first wire; and
a cut out in a conductive sheath wrapped circumferentially around the tubular guidewire sheath.
5 . The catheter of claim 4 , wherein the cut out is defined by a hole in the conductive sheath.
6 . The catheter of claim 4 , wherein the tubular guidewire sheath comprises an aperture extending between an outer surface of the tubular guidewire sheath and the second lumen, wherein the aperture is positioned over the insulation removed portion of the first wire such that current flows through the aperture when the high voltage pulses are applied across the reinforced wire sheath and the first wire.
7 . The catheter of claim 4 , wherein the at least one electrode pair comprises a second electrode pair, the second electrode pair comprising:
an edge of the conductive sheath; and
a conductive emitter portion coplanar with the conductive sheath, wherein the emitter portion is electrically coupled to the reinforced wire sheath.
8 . The catheter of claim 7 , wherein the edge of the conductive sheath comprises a groove, and wherein the emitter portion comprises a coplanar tongue extending into the groove such that the tongue and groove define a U-shaped gap between the emitter portion and the edge of the conductive sheath.
9 . The catheter of claim 7 , wherein the first electrode pair and the second electrode pair are located approximately 180 degrees apart circumferentially around the conductive sheath.
10 . The catheter of claim 1 , wherein the tubular guidewire A sheath further defines one or more fluid lumens for carrying the conductive fluid between a proximal end of the catheter and the cap.
11 . The catheter of claim 1 , wherein the tubular guidewire sheath comprises a fluid inlet for flowing the conductive fluid into the cap and a fluid outlet for flowing the conductive fluid out of the cap, and wherein the at least one electrode pair is positioned between the fluid inlet and the fluid outlet such that the conductive fluid flowed through the cap flows across the at least one electrode pair.
12 . The catheter of claim 1 , wherein the reinforced wire sheath comprises at least one braided or coiled metal wire encapsulated in a polymer.
13 . The catheter of claim 12 , wherein the metal wire is flattened to reduce a profile of the reinforced wire sheath.
14 . The catheter of claim 12 , wherein the metal wire comprises at least one of copper and stainless steel.
15 . The catheter of claim 1 , wherein the distal tip is a soft tip that tapers toward the distal end of the catheter.