Apparatus and method for advancing catheters or other medical devices through a lumen

Inventors

Sardesai, Rajendra Gurudas • PANCHOLY, SAMIR BIPIN • Patel, Tejas Madhusudan

Assignees

Vasoinnovations Inc

Abstract

Devices, systems, and methods are disclosed that help deliver catheters or other medical devices to locations within a patient's body. The device includes a transporter catheter having a proximal end and a distal end, at least a first balloon located at the distal end, substantially at a tip of the transporter catheter, and at least a second balloon located between the distal end and the proximal end of the transporter catheter. The first balloon is an orienting balloon and the second balloon is an anchor balloon. The transporter catheter may include a single lumen or more than one lumen. The transporter catheter may include a shaft including an inner layer and an outer layer, the inner layer may be made of a material more flexible than the material of the outer layer. The outer layer may also include a braided-wire assembly, said braided-wire assembly being formed by braiding a plurality of flat wires or circular wires. The braided-wire assembly may wrap around the inner layer. The transporter catheter may include a shaft that may include a plurality of segments of varying degrees of hardness. The degree of hardness of the segment of the shaft of the transporter catheter located between the first balloon and the second balloon may be less than the degree of hardness of the segment of the shaft between the second balloon and the proximal end of the catheter.

Core Innovation

The document describes an intravascular treatment system in which a transporter catheter is assembled with an outer catheter, where the transporter catheter includes a shaft, at least one anchor balloon, and an orienting balloon. The outer catheter comprises a lumen, a proximal region and a distal region, and the transporter catheter is anchored inside the lumen of the outer catheter at least in the distal region of the outer catheter. The orienting balloon is situated proximal to a distal end of the transporter catheter and is inflated during advancement to support navigation and positioning in a vessel of interest.

To address a potential razor effect of an edge of the outer catheter, the orienting balloon is inflated such that a diameter of at least a protruding portion of the orienting balloon is greater than an outer diameter of the outer catheter, thereby reducing or eliminating the potential razor effect. The system further enables adjusting a stiffness of the intravascular treatment system at least in the distal region of the outer catheter by adjusting a pressure of a fluid inside the orienting balloon and/or the at least one anchor balloon.

The document also describes embodiments in which the transporter catheter is steerable via a steering mechanism connected to the transporter catheter and/or the outer catheter, and the catheter includes a radiopaque marker on at least a distal region. A guidewire is extended along an internal channel of the transporter catheter such that proximal and distal ends extend beyond ends of the transporter catheter, and the anchor balloon anchoring can include pressing against an inner surface of the lumen of the outer catheter in a distal region. Additionally, the document discloses delivery of a prosthetic heart valve by advancing a prosthetic heart valve toward a native diseased valve, separating the transporter catheter from the outer catheter by deflating an anchor balloon, and advancing the transporter catheter distally to position the prosthetic valve at a treatment site.

Claims Coverage

The document includes three independent claims for methods of intravascular treatment that share a common framework: assembling a transporter catheter with an outer catheter, inflating anchor and orienting balloons, adjusting stiffness by balloon-fluid pressure, and advancing while the outer catheter slidably engages a vessel wall. The independent claims add inventive elements related to razor-effect reduction, guidewire extension, steerability, and prosthetic heart valve delivery with anchor-balloon disengagement.

Overall, the independent claims cover a transporter catheter system and method where distal anchoring and proximal orientation are provided by inflatable balloons, stiffness is adjusted by balloon-fluid pressure, and advancement is performed while the outer catheter slidably engages the vessel wall; additional coverage includes razor-effect reduction via orienting balloon protrusion beyond the outer catheter diameter, guidewire extension along an internal channel, steerability via a steering mechanism, radiopaque marker placement, and prosthetic heart valve delivery using staged anchor-balloon disengagement.

Stated Advantages

Documented Applications