Devices, systems, and methods for delivering catheters or other medical devices to locations within a patients body

Inventors

Sardesai, Rajendra Gurudas • PANCHOLY, SAMIR BIPIN

Assignees

Vasoinnovations Inc

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Publication Number

US-11925775-B2

Patent

Publication Date

2024-03-12

Expiration Date


Abstract

Devices, systems, and methods are disclosed that help deliver catheters or other medical devices to locations within a patient's body. The device comprises 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 comprising 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 comprise 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 comprise 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 invention relates to advancing an introducer catheter towards a treatment site through a lumen in a patient's vasculature by assembling the introducer catheter with a transporter catheter. The transporter catheter extends within a lumen of the introducer catheter and includes a shaft with a proximal end and a distal end. The method uses inflatable balloon structures formed on the transporter catheter to establish temporary anchoring and orientation during advancement.

A first balloon function is provided by inflating at least one anchor balloon formed on the transporter catheter to anchor the transporter catheter to the introducer catheter. A second balloon function is provided by inflating at least one orienting balloon formed proximate a distal end of the transporter catheter, where the orienting balloon upon inflation protrudes at least partially outside the distal end of the introducer catheter and engages a wall of a lumen in the patient's vasculature. After the introducer catheter is advanced to a location of interest, the orienting balloon is deflated and the anchor balloon is deflated to remove the anchoring.

The transporter catheter system is further defined through guidewire support and steerable-guide advancement options. In embodiments, the introducer catheter includes at least one internal channel for a guidewire and the guidewire is extended so that a distal end extends beyond the distal end of the transporter catheter while a proximal end extends beyond the proximal end of the transporter catheter, and the distal end is advanced toward the location of interest. In additional embodiments, the introducer catheter is a steerable-guide catheter with a handle assembly including a deflecting mechanism connected to a distal end region to apply a deflecting force, and advancing is performed by selecting from pushing and/or torqueing of the steerable-guide catheter, the transporter catheter, or both. Shaft behavior is constrained by varying degrees of hardness, including a softer segment of the shaft located between the orienting balloon and the anchor balloon than the segment located between the anchor balloon and the proximal end of the transporter catheter.

Claims Coverage

The partial content provides three independent claims that share a balloon-anchored transporter approach for advancing an introducer catheter to a location of interest. Across the independent claims, the coverage centers on assembling an introducer and transporter system, using anchor and orienting balloons for anchoring and lumen engagement, advancing to the location of interest, and deflating balloons and removing the transporter catheter, with additional coverage for guidewire extension, steerable-guide pushing and/or torqueing, and shaft hardness relationships.

Assembling a transporter-in-introducer system

Assembling a system comprising an introducer catheter and a transporter catheter, wherein the transporter catheter extends within the lumen of the introducer catheter and the transporter catheter includes a shaft with a proximal end and a distal end.

Anchor-and-orient balloon control for positioning during advancement

Inflating at least one anchor balloon formed on the transporter catheter to anchor the transporter catheter to the introducer catheter, and inflating at least one orienting balloon formed proximate the distal end of the transporter catheter such that, upon inflation, the orienting balloon protrudes at least partially outside the distal end of the introducer catheter and engages a wall of a lumen in the patient's vasculature while advancing the introducer catheter to a location of interest.

Deflate and remove transporter after orienting advancement

Deflating the at least one orienting balloon, deflating the at least one anchor balloon to remove anchoring between the transporter catheter and the introducer catheter, and removing the transporter catheter from within the lumen of the introducer catheter after advancing to the location of interest.

Guidewire extension beyond transporter ends for target positioning

Providing at least one internal channel for a guidewire in the introducer catheter, extending the guidewire along the at least one internal channel of the transporter catheter with a proximal end extending beyond the proximal end of the transporter catheter and a distal end extending beyond the distal end of the transporter catheter, and advancing the distal end of the guidewire toward a location of interest.

Steerable-guide advancement by selecting pushing and/or torqueing

Defining the introducer catheter as a steerable-guide catheter comprising at least one handle assembly with a deflecting mechanism connected to a distal end region, and performing advancement through the patient's vasculature by selecting from pushing and/or torqueing the steerable-guide catheter, the transporter catheter, or both.

Anchor balloon located proximal to orienting balloon and shaft hardness segmentation

Locating at least one anchor balloon proximal to at least one orienting balloon, and providing the transporter shaft with plurality of segments having varying degrees of hardness such that the segment of the shaft between the at least one orienting balloon and the at least one anchor balloon has hardness less than the segment between the at least one anchor balloon and the proximal end of the transporter catheter.

Across the independent claims, the core claim coverage is a method that advances an introducer catheter to a location of interest by using inflated anchor and orienting balloons on a transporter catheter positioned within the introducer lumen, then deflating and removing the transporter catheter. Additional coverage includes extending a guidewire beyond both ends of the transporter catheter for target positioning, and employing a steerable-guide catheter where advancement is performed by selecting pushing and/or torqueing among the steerable-guide catheter, transporter catheter, or both, together with an anchor/proximal-to-orienting arrangement and a shaft segment hardness relationship.

Stated Advantages

Documented Applications

No documented applications found

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