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

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Publication Number

US-10821267-B1

Patent

Publication Date

2020-11-03

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 a transporter catheter system for advancing through a patient's vasculature in tortuous lumens. The system uses at least one orienting balloon positioned on the shaft adjacent to the distal end and configured to slidably engage an inner surface of a patient's vasculature when pressurized, and at least one anchoring balloon positioned on the shaft between the orienting balloon and the proximal end and configured to non-slidably engage and anchor the transporter catheter to an inner surface of an outer catheter when pressurized.

The shaft includes at least one lumen for a guidewire, and at least a portion of the guidewire lumen is configured not to constrict under pressure when the anchoring balloon is pressurized and when the orienting balloon is pressurized, whereby the transporter catheter is not locked to the guidewire. The outer catheter is configured to slidably engage a vessel wall as the transporter catheter is pushed and/or torqued to advance with both balloons pressurized for their respective engagement modes.

The catheter system further incorporates structural and functional features for maneuverability and torque transfer, including reinforcement to prevent constriction and locking under balloon pressure. Reinforcement includes a braided-wire assembly or plait matrix or a helical coil torque-transfer layer, and the shaft can include varying shaft hardness along segments to enhance maneuverability and kink resistance.

Additional embodiments include perfusion or flow lumens across balloons, optional steerability using pull-wires, steerable-guide catheter embodiments with deflecting mechanisms, balloon surface features such as serrations and raised projections for enhanced anchoring friction, imaging via radiopaque markers, and hydraulic advancement using a piston and a hydraulic fluid lumen.

Claims Coverage

The document provides coverage for three independent transporter-catheter claims, centered on balloon-based orientation and anchoring, maintaining a non-constricting guidewire lumen to avoid locking, and advancing the catheter while the outer catheter slidably engages the vessel wall. Dependent refinements include structural reinforcement for guidewire lumen regions, steering via pull-wires, separate balloon inflation and deflation lumens, torque-transfer layers, anchoring-friction structures, and radio-opaque visibility markers.

Dual-balloon orienting and anchoring engagement with outer catheter

A shaft comprising at least one orienting balloon configured to slidably engage an inner surface of a patient's vasculature when pressurized, and at least one anchoring balloon positioned between the orienting balloon and the proximal end configured to non-slidably engage and anchor the transporter catheter to an inner surface of an outer catheter when pressurized.

Non-constricting guidewire lumen to prevent locking

At least a portion of the at least one lumen for the guidewire configured not to constrict under pressure when the anchoring balloon is pressurized and when the orienting balloon is pressurized, whereby the transporter catheter is not locked to the guidewire.

Advancing by pushing and/or torquing with both balloons pressurized

The outer catheter configured to slidably engage a vessel wall in the patient's vasculature as the transporter catheter is pushed and/or torqued to advance through the patient's vasculature with both the at least one orienting balloon pressurized to slidably engage the inner surface of the patient's vasculature and the at least one anchoring balloon pressurized to non-slidably engage the inner surface of the outer catheter.

Reinforced guidewire lumen under balloon regions

A guidewire lumen reinforced with a tube covering over portions located beneath the anchoring balloon and the orienting balloon, where the tube covering material is more rigid than the shaft core material, or a guidewire lumen reinforced with a braided-wire plait matrix over portions located beneath the anchoring balloon and the orienting balloon.

Separate lumens for orienting and anchoring balloon inflation/deflation

The shaft comprising a first lumen to inflate and deflate the orienting balloon and a second lumen to inflate and deflate the anchoring balloon.

Pull-wire steerability

The transporter catheter steerable by at least one longitudinal pull-wire disposed along a length of the transporter catheter.

Helical coil and/or plait-matrix torque-transfer layer

A torque-transfer layer in the shaft comprising a helical coil and/or a plait-matrix.

Friction-based anchoring between anchoring balloon and outer catheter

The anchoring balloon uses a friction-based mechanism between the anchoring balloon's outer surface and the inner surface of the outer catheter.

Radio-opaque marker for visibility

At least one radio-opaque marker included in the transporter catheter.

Across the independent claims, the core coverage is the combination of an orienting balloon for slidably engaging the patient vasculature, an anchoring balloon for non-slidably anchoring to an outer catheter, and maintaining a guidewire lumen that does not constrict under balloon pressure to avoid locking to the guidewire while the transporter catheter is pushed and/or torqued with both balloons pressurized. The claim set also supports dependent refinements that add guidewire lumen reinforcement, separate balloon inflation and deflation lumens, steering via pull-wires, torque-transfer layers, friction-based anchoring structures, and radio-opaque markers.

Stated Advantages

Allows the transporter catheter to advance through tortuous lumens while the orienting balloon slidably engages the inner surface and the anchoring balloon non-slidably anchors to the outer catheter.

Prevents the transporter catheter from being locked to the guidewire when either the anchoring balloon or the orienting balloon is pressurized.

Supports pushing and/or torquing advancement while the outer catheter slidably engages the vessel wall as the balloons maintain their respective engagement modes.

Enhances maneuverability and kink resistance through varying shaft hardness along segments and balloon surface features enhancing anchoring friction.

Provides reinforcement to prevent constriction and locking under balloon pressure and provides torque-transfer reinforcement through specified torque-transfer layers.

Enables imaging and visibility via radio-opaque marker.

Reduces razor effect and allows use of thinner-walled outer catheters.

Documented Applications

Transporter catheter advancement through a patient's vasculature, including advancement in tortuous lumens, using orienting and anchoring balloons and an outer catheter while pushing and/or torquing.

Perfusion or flow through the catheter system via lumens across balloons.

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