US-12623056-B2 - Scoring balloon catheter with enhanced pushability and maneuverability

US12623056B2US 12623056 B2US12623056 B2US 12623056B2US-12623056-B2

Abstract

A device for introduction into a body vessel includes a shaft ( 105 ), a balloon ( 115 ) positioned at the distal end of the shaft ( 105 ), and at least one longitudinal scoring wire ( 135 ) to score a vascular lesion attached to the distal end of the shaft ( 105 ), disposed over the balloon ( 115 ). The shaft ( 105 ) includes a support ( 119 ), such as a wire or tube having one or more spirally cut portions ( 119 A, 119 B), which improves pushability and trackability, thereby allowing for use with an external guidewire in a “short rapid exchange” (SRX) format. The balloon ( 115 ) expands when fluid is delivered to the balloon ( 115 ) through the inflation lumen. This expansion pushes the scoring wire and guidewire against the vascular lesion.

Inventors

Katherine Huffer
Mark Nicholas WRIGHT

Assignees

C.R. BARD, INC.

Dates

Publication Date: 20260512
Application Date: 20200610

Claims (15)

1 . A balloon catheter, comprising: a shaft having a proximal end section, a distal end section, and a support extending from the proximal end section to the distal end section of the shaft, at least a portion of the support comprising a solid wire with spiral cut portion; a hub mounted to the proximal end section of the shaft; an inflatable balloon mounted on the distal end section of the shaft, wherein at least a portion of the support positioned within the shaft between the proximal end section and the inflatable balloon; and at least one scoring wire having a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon; wherein the distal end section of the shaft includes a guidewire lumen having an inlet distal of the balloon and an outlet distal of the inflatable balloon.
2 . The balloon catheter of claim 1 , wherein the spiral cut portion of the wire is located within the distal end section of the shaft.
3 . The balloon catheter of claim 1 , wherein the spiral cut portion of the wire is located within the hub.
4 . The balloon catheter of claim 1 , further including a spring for connecting the second end of the scoring wire to the proximal end section of the shaft.
5 . The balloon catheter of claim 1 wherein the at least one scoring wire comprises two scoring wires, and the shaft includes a lumen for each scoring wire.
6 . The balloon catheter of claim 1 , further including a guidewire extending through the guidewire lumen and including a portion running alongside the balloon.
7 . A balloon catheter, comprising: a shaft having a proximal end section, a distal end section, and a support extending from the proximal end section to the distal end section, at least a portion of the support comprising a solid wire with a spiral cut portion; a hub mounted to the proximal end section of the shaft; an inflatable balloon mounted on the distal end section of the shaft, the distal end section of the shaft including a guidewire lumen having an inlet distal of the balloon and an outlet distal of the inflatable balloon; a guidewire adapted to pass through a lumen in a distal tip of the shaft; and at least one scoring wire having a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon.
8 . A balloon catheter, comprising: a shaft having a proximal end section, a distal end section, and a solid support wire extending at least partially within the shaft from the proximal end section to the distal end section, at least a portion of the solid support wire comprising a spiral cut portion; a hub mounted to the proximal end section of the shaft; an inflatable balloon mounted on the distal end section of the shaft; and a guidewire lumen having an inlet distal of the inflatable balloon and an outlet distal of the inflatable balloon.
9 . The balloon catheter according to claim 8 , further including at least one scoring wire having a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon.
10 . The balloon catheter according to claim 9 , wherein the second end is movably connected to the proximal end section of the shaft.
11 . The balloon catheter according to claim 10 , further including a spring for connecting the second end of the scoring wire to the proximal end section of the shaft.
12 . The balloon catheter of claim 8 wherein the at least one scoring wire comprises two scoring wires, and the shaft includes a lumen for each scoring wire.
13 . The balloon catheter of claim 8 , wherein the spiral cut portion of the support wire is located within the distal end section of the shaft.
14 . The balloon catheter of claim 8 , wherein the spiral cut portion of the support wire is located within the hub.
15 . The balloon catheter of claim 8 , further including a guidewire extending through the guidewire lumen and including a portion running alongside the balloon.

Description

INCORPORATION BY REFERENCE All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. BACKGROUND OF THE INVENTION Balloon dilatation catheters are used to treat lesions in vessels. However, difficulties are encountered in navigating tortuous anatomy and safely crossing very tight lesions. Moreover, some lesions are difficult to dilate using just a balloon, and require a focused force to dilate the lesion at safe inflation pressures. U.S. Pat. No. 6,394,995 to Solar et al. describes a system used to provide enhanced force to treat a lesion. This system has a flexible advancement member with a tracking member slidable over a guidewire, and a balloon having a distal end attached to the tracking member. This type of system provides limited focused force, and suffers from a lack of enhanced pushability (e.g, kink resistance) and maneuverability. SUMMARY OF THE INVENTION According to an aspect of the disclosure, a balloon catheter is provided with enhanced pushability and maneuverability, by virtue of the omission of an internal guidewire and the inclusion of a support, such as a wire or tube, having one or more spiral cut or spring-like portions. In one aspect, the disclosure pertains to a balloon catheter having a shaft with a proximal end section, a distal end section, and a support extending from the proximal end section to the distal end section of the shaft. At least a portion of the support comprises a spiral cut portion. A hub is mounted to the proximal end section of the shaft, and an inflatable balloon mounted on the distal end section of the shaft. At least one scoring wire is also provided, the at least one scoring wire having a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon. In one embodiment, the support comprises a tube. The spiral cut portion of the tube may be located within the distal end section of the shaft, within the hub, or both. The support may alternatively comprise a wire, which may also be located within the distal end section of the shaft, the hub, or both. The balloon catheter may include a spring for connecting the second end of the scoring wire to the proximal end section of the shaft. The at least one scoring wire may comprise two scoring wires, and the shaft may include a lumen for each scoring wire. The distal end section of the shaft includes a guidewire lumen having an inlet distal of the balloon and an outlet distal of the inflatable balloon. According to a further aspect of the disclosure, a balloon catheter includes a shaft having a proximal end section, a distal end section, and a support extending from the proximal end section to the distal end section, at least a portion of the support comprising a spiral cut portion. A hub is mounted to the proximal end section of the shaft, and an inflatable balloon is mounted on the distal end section of the shaft, the distal end section of the shaft including a guidewire lumen having an inlet distal of the balloon and an outlet distal of the inflatable balloon. At least one scoring wire includes a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon. In one embodiment, the second end of the at least one scoring wire is movably connected to the proximal end section of the shaft. The support may comprise a tube, with the spirally cut portion of the tube is located within the distal end section of the shaft or within the hub (or both). The support may alternatively comprise a wire, which may be similarly located. Still another aspect of the disclosure relates to a balloon catheter, comprising a shaft having a proximal end section, a distal end section, and a support wire extending from the proximal end section to the distal end section, at least a portion of the support wire comprising a spiral cut portion. A hub is mounted to the proximal end section of the shaft, and an inflatable balloon is mounted on the distal end section of the shaft. In one embodiment, the balloon catheter includes at least one scoring wire having a first end fixed on the shaft between a shaft distal end and the inflatable balloon, a second end connected to the proximal end section of the shaft, and an intermediate portion running alongside of the inflatable balloon. The second end is movably connected to the proximal end section of the shaft. A spring may also be provided for connecting the second end of the scoring wire to the proximal end section of the shaft. The at least one scoring wire may comprise two scoring wires, and t