Automated vessel puncture device using three-dimensional(3d) near infrared (nir) imaging and a robotically driven needle

Abstract

The present invention is directed to an automated vessel puncture device, methods of mapping three-dimensional views of subcutaneous vessels and methods for providing simultaneous real-time diagnostic assay.

1 . A portable automated venipuncture device adapted for placement on an appendage of a human, comprising:
 i) a near infrared three-dimensional imaging system for illuminating a target vein for venipuncture comprising at least one infrared light source for emitting infrared light and at least one light detector for capturing reflected near infrared light from the target vessel;   ii) an automated robotic end-effector unit comprising a needle for target vessel puncture and a needle guidance system that utilizes haptic and force feedback profiles for positioning the needle at the target vessel; and   iii) a computer connected to the imaging system and end-effector unit, said computer receiving information from the imaging system and end-effector unit and generating haptic force and feedback profiles to position the needle and adjust the amount of force applied to the needle to puncture the target vessel of a human, such that when the imaging system and the end-effector unit are attached to an appendage of a human a three-dimensional map of subcutaneous vessel is generated and an optimal vessel is targeted for venipuncture.   
     
     
         2 . The portable automated venipuncture device of  claim 1 , wherein the near infrared light source has a frequency range from about 700 nm to about 910 nm. 
     
     
         3 . The portable automated venipuncture device of  claim 2 , wherein the near infrared light source has a frequency range from about 730 nm to about 850 nm. 
     
     
         4 . The portable automated venipuncture device of  claim 2 , wherein the near infrared light source is a light emitting diode. 
     
     
         5 . The portable automated venipuncture device of  claim 1 , wherein the light detector is selected from the group consisting of photodetectors, and near infrared charged-coupled device (CCD) cameras. 
     
     
         6 . The portable automated venipuncture device of  claim 1 , wherein the imaging system comprises an array of nine light emitting diodes and four photodetectors, wherein the array of light emitting diodes and photodetectors provides for sixteen light emitting diode/detector pairings, each corresponding to an orientation of a subcutaneous vessels of a human. 
     
     
         7 . The portable automated venipuncture device of  claim 6 , wherein a raw measurement of the imaging system is calculated using Formula (I):
   D=(fdeoxy,1-foxy,1)-(fdeoxy,2-foxy,2)   
       where  1  and  2  are two different light emitting diodes, D is a vector, having a magnitude representing the difference of differential absorption and a direction representing any two paths enumerate in  FIG. 8 . 
     
     
         8 . The portable automated venipuncture device of  claim 7 , wherein the measurement is used to reconstruct positioning and orientation of the subcutaneous veins. 
     
     
         9 . The portable automated venipuncture device of  claim 1 , wherein the light detector generates near infrared video images of the target vein based on the light reflected from the target vein. 
     
     
         10 . The portable automated venipuncture device of  claim 9 , wherein the video images are provided to the computer through an interface cable, and the computer captures still images of the target vein, the still images being stored in digital format on a digital storage device. 
     
     
         11 . The portable automated venipuncture device of  claim 10 , wherein the digital storage device is connected to the computer. 
     
     
         12 . The portable automated venipuncture device of  claim 10 , wherein the digital storage device is inside the computer. 
     
     
         13 . The portable automated venipuncture device of  claim 10 , wherein combining multiple near infrared images of the target vein are combined with diffuse optical tomography (DOT) techniques to generate a three dimensional representation of the target vessel. 
     
     
         14 . The portable automated venipuncture device of  claim 1 , wherein the light emitting diodes are at about a 0° to about 90° angle of dispersion for maximizing concentration of the light source at selected location within a target vessel. 
     
     
         15 . The portable automated venipuncture device of  claim 1 , wherein the light emitting diodes are at about a 15° to about a 30° angle of dispersion for maximizing concentration of the light source at selected location within a target vessel. 
     
     
         16 . The portable automated venipuncture device of  claim 1 , wherein the light source is secured to an imaging system housing plate. 
     
     
         17 . The portable automated venipuncture device of  claim 1 , wherein the imaging system housing plate is a printed circuit board with integrated contacts for connecting to a battery source. 
     
     
         18 . The portable automated venipuncture device of  claim 16 , wherein a position sensor for providing a measurement of the distance from the light source and needle to a target vessel is secured to the imaging system housing plate. 
     
     
         19 . The automated venipuncture device of  claim 1 , wherein the light detector further comprises a filter and lens. 
     
     
         20 . The automated venipuncture device of  claim 1 , wherein the light source and light detectors are fixed to a pivotable, motorized platform for providing image acquisition of target vessels from various angles. 
     
     
         21 . The automated venipuncture device of  claim 1 , wherein the imaging system and end effector unit are enclosed in a cuff. 
     
     
         22 . The portable automated venipuncture device of  claim 1 , wherein the automated robotic end-effector unit further comprises a needle device carrier, a needle device carrier housing and a plurality of servo motors for controlling the movement of the needle. 
     
     
         23 . The portable automated venipuncture device of  claim 1 , wherein the computer is a portable lap top computer. 
     
     
         24 . A method of mapping a three-dimensional view of subcutaneous veins for automated venipuncture utilizing the automated venipuncture device of  claim 1 , comprising:
 i) attaching the portable automated venipuncture device on an appendage of a human;   ii) capturing still images of subcutaneous vessels on the computer generated from the near infrared three-dimensional imaging system of the automated venipuncture device;   ii) creating an image threshold using profiles of pixel intensity values of the still images, and refining contrast and clarity of the image;   iii) conducting segment surface extraction and smoothing to define boarders and midline of subcutaneous vessels;   iv) conducting mesh generation to define a default three-dimensional geometry representing size and shape of the subcutaneous vessels;   v) optimizing the mesh generation using segmented images to generate a true three-dimensional representation of the subcutaneous vessels; and   vi) obtaining a final three-dimensional volumetric reconstruction of the subcutaneous veins.   
     
     
         25 . A method of controlling the needle positioning of the venipuncture device of  claim 1 , comprising the steps of:
 i) calculating a relative target position of the needle tip utilizing a three-dimensional volumetric reconstruction of subcutaneous vessels;   ii) calculating a reference distance of the needle tip utilizing a position sensor located on the imaging system;   iii) calculating the absolute target position of the needle tip based on the relative target position of step i) that is adjusted based on the reference distance of step ii);   iv) tracking the displacement of the needle device carrier by the position sensor;   v) evaluating 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; and   vi) ensuring the correct angle of injection utilizing fine motor positioning adjustments, such that venipuncture to an optimal vein is provided.   
     
     
         26 . The method of  claim 25 , wherein the fine motor positioning adjustments are performed by the servo motors. 
     
     
         27 . A method for providing simultaneous real-time diagnostic assays, comprising:
 i) obtaining a blood sample utilizing the self contained, automated venipuncture device of  claim 1 ; and   ii) simultaneously introducing said blood sample into a point of care diagnostic assay.