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EP-4740892-A2 - STEERABLE LOCKING CATHETER

EP4740892A2EP 4740892 A2EP4740892 A2EP 4740892A2EP-4740892-A2

Abstract

The steerable catheter invention facilitates the tracking and selection of branch vessels, as well as provide the means for stiffening the catheter body across the tortuosity to anchor the catheter and minimize the potential for the catheter backing out of position while delivering interventional devices to the distal anatomy.

Inventors

  • LORENZO, JUAN

Assignees

  • DePuy Synthes Products, Inc.

Dates

Publication Date
20260513
Application Date
20191223

Claims (5)

  1. A steerable catheter comprising: a flexible distal shaft comprising: a first primary direction of flexibility; a second primary direction of flexibility; a first secondary direction of flexibility; a second secondary direction of flexibility; an inner layer; a segmented mid-layer with different oriented notches comprising: a primary plurality of notches comprising a primary depth, a primary outer width, and a primary inner width; and wherein the primary depth, the primary outer width, and the primary inner width are related to the primary angle of flexibility; wherein the primary outer width is greater than the primary inner width; wherein the primary plurality of notches are configured to bend in the first primary direction of flexibility; a secondary plurality of notches comprising a secondary depth, a secondary outer width, and a secondary inner width; wherein the secondary depth, the secondary outer width, and the secondary inner width are related to the secondary angle of flexibility; the secondary outer width is greater than the secondary inner width; and wherein the secondary plurality of notches are configured to bend in the first secondary direction of flexibility; and an outer layer.
  2. The steerable catheter of claim 1, wherein the proximal hub comprising a label to indicate the first primary direction of flexibility and the first secondary direction of flexibility.
  3. The steerable catheter of claim 1 or claim 2, wherein the outer layer is elastic.
  4. The steerable catheter of any one of claims 1 to 3, wherein the outer layer comprises a radiopaque element to determine the first primary direction of flexibility.
  5. The steerable catheter of any one of claims 1 to 4, wherein the outer layer comprises a radiopaque element to determine the first secondary direction of flexibility.

Description

Field of Invention The present invention generally relates to medical instruments, and more particularly, to a steerable locking catheter system. Background Catheters can be pliable tubular structures that enter vasculature of a patient. Catheters can be used for a variety of purposes and applications. For example, they can be introduced into a particular area of interest within a vasculature and then act as a guide for introducing other peripheral, central venous, or arterial devices therein through its lumen. Such devices can include single or multi-lumen catheters, clot capturing devices, balloon catheters, and the like. Tracking of catheters through tortuous anatomy can be challenging, especially for larger diameter catheters. These catheters are difficult to track in the presence of tortuosity and selecting branch vessels makes it more difficult. In addition, once the catheter is tracked through tortuous vasculature, and an interventional device (such as a stent, clot retriever, aspiration catheter, etc.) is advanced through the lumen of the catheter, it often results in the catheter backing out of position. If this occurs, the physician must remove the interventional device and then re-access the tortuous segment with the catheter prior to re-attempting delivery of the interventional device. Therefore, there remains a need for new devices to safely and effectively advance catheters to locations of interest in a more controlled manner to resolve these and other problems of the art. Summary This invention facilitates the tracking and selection of branch vessels, as well as provide the means for stiffening the catheter body across the tortuosity to anchor the catheter and minimize the potential for the catheter backing out of position while delivering interventional devices to the distal anatomy. The catheter consists of a torqueable shaft with a flexible distal end. The flexible distal end can be configured to be flexible in one direction and stiffer in the opposite direction. The flexibility of the distal end governed by a feature in the distal assembly designed to facilitate bending in one direction, while resisting bending in the opposite direction. The feature comprising a laser cut tubular element configured to flex preferentially in one direction while opposing flexure in the opposite direction. The tubular element is encapsulated (fused) between layers of flexible polymer. The hub of the catheter is labeled to indicate the direction of flexibility so that the user can more easily steer the catheter through the vasculature. If the user approaches a bifurcation and desires to track down the vessel rather than in the direction of the bifurcated vessel, the user torques the shaft such that the flexible direction of the distal element is away from the bifurcation, thus facilitating tracking of the device away from the bifurcation. If the user desires to track in the direction of the bifurcation, the user will then torque the shaft such that the flexible direction of the distal element is in the direction of the bifurcation, thus facilitating access to the bifurcated vessel. To access through tortuosity and prevent the catheter from backing out of position, the user first aligns the flexible segment to access through tortuosity as described above. Once the catheter has crossed the tortuous segment, the user torques the catheter such that the flexible segment reverts inside of the dominant curve and the less flexible segment stiffens inside the curve. This results in the catheter locking itself in the curve and resisting backwards movement as interventional devices are tracked through its lumen. Disclosed herein are various exemplary devices for a steerable catheter or steerable locking catheter that can address tracking of catheter through tortuous anatomy and other problems of the art. The devices can generally include a proximal hub, a proximal shaft, an intermediate shaft, and a flexible distal shaft. The flexible distal shaft having a proximal end and a distal end. The intermediate shaft having a proximal end and a distal end wherein the distal end of the intermediate shaft is connected to the proximal end of the flexible distal shaft. The proximal shaft having a proximal end and a distal end, wherein the distal end of the proximal shaft is connected to the proximal end of the intermediate shaft. The proximal hub comprising a proximal end and a distal end, wherein the distal end of the proximal hub is connected to the proximal end of the proximal shaft. The devices can also generally include a flexible distal shaft that has a first direction of flexibility and a second direction of flexibility opposite to the first direction of flexibility. The flexible distal shaft can be torqued such that the first direction of flexibility is in the direction of the desired direction of travel, thus facilitating access to the bifurcation of the vasculature or a desired vessel. The devices can also generally inclu