Needle and Guidewire Insertion System

LU 2021-006

INVENTORS
Paul Tannous, MD, PhD
Alan Nugent, MBBS
 
SHORT DESCRIPTION
A device that allows a single operator using the modified Seldinger technique to obtain endovascular or endoluminal access and advance a guidewire under continuous ultrasound guidance.  

BACKGROUND
Establishing endovascular and endoluminal access is a critical step in interventional cardiology, interventional radiology, and many other fields utilizing a percutaneous approach.  Ultrasound-guided modified Seldinger technique is the standard of care for most percutaneous procedures requiring endoluminal access, including to vascular, plural, pericardial, and peritoneal spaces. With current technology, a single operator advances the access needle under continuous ultrasound imaging, but must abandon the imaging probe, disconnect the access syringe, and then advance the guide wire. The time it takes to load the guidewire results in blood loss, and advancing the wire without ultrasound guidance increases the risk for malposition, perforation, or vessel dissection. A system in which a single operator can access the luminal space and advance the guidewire with continuous ultrasound imaging would significantly improve the safety profile of this procedure.

ABSTRACT
Interventional Cardiologists at Lurie Children’s Hospital have developed the PXTSidearm, a device that allows a single operator to maintain continuous ultrasound guidance while obtaining endovascular/endoluminal access and advancing a guidewire. This device is low-cost, single-use, and compatible with all commercially available access needles and guidewires. The device connects to the female luer fitting on the access needle and pre-loads the guidewire into its sidearm. The operator uses one hand to insert the needle and guidewire while using the other hand to manipulate the ultrasound probe. Once the needle is in the luminal space, the operator can immediately advance wire while maintaining continuous ultrasound imaging, thus decreasing the risk for vascular trauma and minimizing blood loss.  A protype device has successfully demonstrated proof of principle and ease of use in a high-fidelity vascular access model.  

APPLICATIONS

• Venous and arterial endovascular access
• Pericardial drain placement
• Chest tube placement

ADVANTAGES

• Allows for continuous ultrasound imaging of needle and wire when accessing the endovascular, pleural, or pericardial space
  • Left hand can continue directing ultrasound probe until guidewire is in desired position
• Compatible with all commercially available wire and needle systems
• No restriction on angle of approach or ultrasound probe used
  • In contrast to fixed-angle devices that attached to ultrasound probe head
• Minimizes blood loss during wire loading
• Easy manufacturing design – simple mold with nearly symmetric sides
• Low-cost, disposable, small storage space
  • Minimal friction to enter an institution’s supply chain
• Option to create custom wires for added ease of use
  • J tip, hash marks on wire to represent needle lengths to ensure wire remains within needle during stick

IP STATUS
Provisional and PCT applications have been filed.

Figure 1: Demonstration of device using a vascular access model.  The PXTSidearm gives a single operator the ability to advance the access needle and guidewire under continuous ultrasound guidance