Vascular targeting system

Inventors

Blackbourne, Lorne H.Salinas, JoseGrisell, Ronald D.

Assignees

United States Department of the Army

Publication Number

US-10765400-B2

Publication Date

2020-09-08

Expiration Date

2036-04-25

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Abstract

An embodiment of the invention provides a method including obtaining ultrasonic images of one or more vessel to be catheterized with an ultrasonic imaging device 212 and identifying the center(s) of the vessel(s) with the ultrasonic images. One of the vessels is punctured with a needle 220 based on the identifying of the center of the vessel. A guide wire 230 is inserted into the vessel and maneuvered with guide wire ultrasonic feedback control. The guide wire ultrasonic feedback control includes obtaining ultrasonic images of the vessel and the guide wire 230 in the vessel, and displaying the ultrasonic images of the vessel and the guide wire 230 in the vessel to a user. A catheter sheath 240 is inserted over the guide wire 230 and maneuvered with sheath ultrasonic feedback control. The guide wire 230 is removed and a catheter 250 is inserted into the catheter sheath 240 and maneuvered with catheter ultrasonic feedback control.

Core Innovation

The invention provides a vascular targeting system and associated methods for the accurate catheterization of blood vessels, using ultrasonic imaging to obtain images of the vessel to be catheterized and identifying the vessel's center automatically via a processor. A needle punctures the vessel at the identified center, and a guide wire is inserted and maneuvered with ultrasonic feedback control. Subsequent insertion of a catheter sheath over the guide wire and, later, a catheter through the sheath, are also performed with ultrasonic imaging feedback and display to the user to ensure precision and safety throughout the procedure.

The method and system include a laser targeting system that projects a laser beam onto the skin surface to accurately designate the puncture point for the needle, with the laser aligned and aimed through computational control according to the ultrasonic imagery data. The system monitors the position and insertion angles, providing visual and audible feedback, alerts when unsafe conditions arise such as excessive force or proximity to vessel walls, and controls inflation of a catheter balloon based on the position within the vessel and blood flow measurements.

The problem solved addresses the difficulties associated with blind or manual insertion of needles and catheters into vessels, complications arising from noisy ultrasonic imagery, false reflections, and uncertainty in vessel identification, which can lead to vessel damage, hemorrhage, or improper catheter placement. The invention improves safety and accuracy by automating vessel center identification, providing visual feedback at each insertion stage, and facilitating rapid and reliable vessel access especially in urgent or austere medical situations.

Claims Coverage

The patent includes independent claims covering both method and system aspects of the vascular targeting invention. There are three main independent claims that detail various inventive features associated with ultrasonic imaging guided catheterization, laser targeting, and feedback-controlled device maneuvering.

Method for ultrasonic guided vessel catheterization with laser targeting and automatic balloon inflation

A method comprising automated identification of the vessel center using ultrasonic images; laser designation of the puncture point on the skin based on the vessel center; puncturing the vessel with a needle; insertion and maneuvering of a guide wire, catheter sheath, and catheter within the vessel all with ultrasonic feedback control; displaying ultrasonic images of vessel and devices to the user; identifying when the catheter reaches a predetermined distance from the puncture point; and automatic inflation of a catheter balloon upon reaching said distance.

Adjustment of catheter balloon inflation based on measured blood flow

Measuring blood flow rate in the vessel and adjusting the amount of air in the catheter balloon accordingly to manage blood flow and hemorrhage control.

Handheld system integrating ultrasonic imaging, laser targeting, and computer control for vessel catheterization

A system comprising a handheld ultrasonic probe for imaging vessels and catheter components; a laser device for directing a puncture point; a display for showing ultrasonic images to the user; and a computer control device that automatically identifies vessel centers, controls the laser for puncture point designation, analyzes images to determine catheter position, and automatically inflates a catheter balloon upon reaching a set distance.

Integration of needle, guidewire, catheter sheath, and catheter with ultrasonic feedback control

The system includes components configured to be controlled by ultrasonic imaging feedback: a needle that punctures the identified vessel center; a guide wire inserted and maneuvered with ultrasonic feedback; a catheter sheath inserted and maneuvered over the guide wire with feedback; and finally a catheter inserted and maneuvered within the sheath with ultrasonic feedback.

Laser targeting methods with motor-controlled, software-computed aiming

Illuminating the skin puncture spot by a laser mounted relative to the ultrasound beam and movable by motors controlled by software which computes aiming angles based on ultrasonic imaging to direct the laser beam through the center of the target vessel at the cross-section plane.

Ultrasonic image processing and vessel identification via histogram line intersections and compression rules

Methods for locating arteries and veins by intersecting histogram intensity peaks in various directions; disambiguation of vessel candidates by geometric configurations; and vessel type differentiation by assessing vessel compressibility and Doppler blood flow signals.

The claims collectively cover a comprehensive method and system for ultrasound-guided vascular access employing automated vessel center identification, laser-guided puncture targeting, real-time ultrasonic feedback control for maneuvering guide wires, sheaths, and catheters, and adaptive biometric-based balloon inflation, supported by advanced image processing and tracking algorithms enhancing vessel identification and safety during catheterization.

Stated Advantages

Enables safer and more accurate catheterization by guiding the needle and catheter insertion precisely to the vessel center using ultrasonic imaging and laser targeting.

Provides visual and auditory feedback during insertion to reduce chances of vessel damage and failed insertions.

Facilitates rapid training of medical personnel by automating vessel identification and insertion guidance.

Allows catheter balloon inflation to be controlled automatically based on catheter position and blood flow measurements, aiding hemorrhage control.

Integrates multiple components including imaging, laser targeting, force sensing, and control algorithms into a portable device suitable for austere and battlefield environments.

Documented Applications

Insertion of central venous catheters including central line catheters and peripherally inserted central catheters (PICC lines).

Insertion of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) catheters for hemorrhage control.

Insertion of chest drains, PEG tubes, pacemaker leads, and other critical vascular access procedures.

Targeted bleeding control in areas such as the iliac artery proximal to the iliac bifurcation, major artery in upper arm, suprapubic artery for abdominal hemorrhage, and subxiphoid artery for pericardial bleeding.

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