TECHNICAL FIELD

The present disclosure relates generally to intravascular devices and, in particular, to catheters having a rapid-exchange port for receiving a guidewire.

BACKGROUND

In a traditional rapid-exchange interventional catheter (e.g., balloon catheter), with a long rapid exchange engagement (e.g., greater than 20 cm), the guidewire entry port on the catheter remains inside the guiding catheter throughout the interventional procedure. The guiding catheter constrains the guidewire to remain in close proximity and parallel to the interventional catheter, and it prevents either the guidewire or interventional catheter from bending significantly. Thus, when the guidewire is advanced, there is little possibility for the guidewire to buckle when resistance to movement within the rapid exchange lumen is encountered. Likewise, when the catheter is advanced over the guidewire, it is constrained from buckling/prolapse by the presence of the guiding catheter.

Rotational IVUS catheters and certain other interventional products (including OCT catheters) typically incorporate a relatively short rapid exchange segment at the tip of the catheter. The rotational IVUS catheter requires a very short rapid exchange tip to permit imaging in the distal segments of the coronary arteries. This short engagement length (typically ˜25 mm) is not ideal and it increases the risk of catheter prolapse, and entanglement of the catheter and guidewire, potentially resulting in damage to one or both devices, or even trauma to the patient's artery as the prolapsed and or entangled devices are removed. However, this short engagement length is required for imaging in the distal portions of the coronary circulation, since the imaging core must terminate proximal to the location where the guidewire enters the catheter. If the guidewire were to engage the rapid exchange port back inside the guiding catheter, then the imaging core could not advance beyond the guiding catheter.

Although this short engagement length is essential for rotational IVUS catheters, there is a weakness in moving the rapid exchange entry port outside the guiding catheter and into the native artery, where there is significantly more lumen space and flexibility. If there is any resistance to guidewire movement through the rapid exchange lumen, then either of two problematic scenarios might arise: (1) advancing the guidewire can cause the guidewire to buckle or prolapse where it is hung up at the entry port, or (2) advancing the catheter might cause the catheter to buckle at the weak spot created by the rapid exchange entry port.

Accordingly, there remains a need for intravascular devices, systems, and methods that include an improved rapid-exchange port.

SUMMARY

Embodiments of the present disclosure are directed to intravascular devices having an improved rapid-exchange port.

In some implementations, an intravascular imaging device is provided that includes: a main catheter body; a rotational imaging element positioned within a lumen of the main catheter body; a distal portion extending from the main catheter body, the distal portion having a rapid-exchange port in communication with a guidewire lumen, the rapid-exchange port and the guidewire lumen sized and shaped to receive a guidewire; and at least one reinforcing element positioned adjacent to the rapid-exchange port. In some instances, the at least one reinforcing element extends from a position proximal of the rapid-exchange port to a position distal of the rapid-exchange port. The at least one reinforcing element can be a wire, a rod, a tapered rod, a tube, a u-shaped trough, and/or a spring coil and formed of a metal, a metal alloy, and/or a plastic. Further, in some instances the guidewire lumen extends offset, but parallel to a central axis of the main catheter body.

Associated systems and methods are also provided. For example, in some implementations a processing system is in communication with the intravascular imaging device. The processing system can be configured to process data obtained by the intravascular imaging device. Further, the system can include a patient interface module configured to interface with a proximal portion of the intravascular imaging device and communicate with the processing system. A display in communication with the processing system can be utilized to visualize information obtained by the intravscular imaging device.

Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

