Patent ID: 9743875
Date: 2017-08-29
CPC Classifications: A61B,A61M

Claim:
1. A portable automated venipuncture device adapted for placement on an appendage of a human to draw blood from an optimal target vessel, comprising: i) a near infrared three-dimensional imaging system enclosed in a cuff-like structure for attachment to an appendage of a human and configured to a subcutaneous target vessel of a human for venipuncture comprising at least one near infrared light source for emitting infrared light and a plurality of light detectors for capturing reflected near infrared light from the target vessel and configured to generate still images of subcutaneous vessels of the human, wherein the device comprises a plurality of near infrared light sources which are light emitting diodes, and the light emitting diodes are at a 15° to a 30° angle of dispersion for maximizing concentration of the light source at selected location within a target vessel; ii) an automated robotic end-effector unit comprising a needle for target vessel puncture and blood acquisition, a pressure sensor configured to detect stretching and deformation of the skin and a needle guidance system that utilizes haptic and force feedback profiles for positioning the needle at the target vessel, adjusting the amount of force applied to the needle, and guiding the needle into the target vessel; iii) a computer connected to the near infrared light source and robotic end-effector unit, said computer configured to receive the still images from the imaging system and generate an image threshold using profiles of pixel intensity values of the still images and refine contrast and clarity of the still images, the computer further configured to utilize the image threshold to conduct segment surface extraction and smoothing to define borders and midline of subcutaneous vessels and conduct mesh generation to define and optimize a true three-dimensional geometry representing size, shape and volumetric reconstruction of the subcutaneous vessels; the computer further configured to calculate (a) a relative target position of the needle tip utilizing the three-dimensional volumetric reconstruction of subcutaneous vessels; (b) a reference distance of the needle tip utilizing a position sensor located on the imaging system; and (c) the absolute target position of the needle tip based on the relative target position of step (a) that is adjusted based on the reference distance of step (b) to provide haptic force and feedback profiles, the computer configured to send the haptic force and feedback profiles to the needle guidance system to position the needle track the displacement of the needle device carrier by the position sensor, and evaluate the displacement of the needle verses the absolute target position utilizing a feedback loop within the automated venipuncture device, wherein needle placement is stopped when the needle displacement and absolute target position coincide, thereby ensuring the correct angle of injection utilizing fine motor positioning adjustments, such that when the imaging system and the robotic end-effector unit are attached to an appendage of a human, the combined use of haptic, imaging and force feedback profiles generate a three-dimensional map of subcutaneous vessel and an optimal vessel is targeted for venipuncture and the needle is guided into the optimal target vessel for blood acquisition; and (iv) a point of care diagnostic assay means, the portable automated venipuncture device configured to introduce a blood sample obtained by the robotic end-effector unit into the point of care diagnostic means to provide one or more assays on the blood sample.