Diagnostic blood testing is the most ubiquitous clinical procedure in the US, with over one billion tests performed annually. The traditional method of blood testing involves performing a venipuncture, transporting samples to a centralized lab, analyzing the samples using large benchtop instruments, relaying the results to the clinician, and following up with the patient. This is a labor intensive, time consuming, and expensive process with unexpected delays often arising from difficulties to successfully perform the venipuncture or the time needed to transport and analyze the sample. Particularly in the hospital emergency department (ED), rapid changes in a patient’s condition necessitate immediate response, and thus delays can be life threatening.
Read MorePoint of care testing
Arterial vs venous blood
Point of care (PoC) blood testing has emerged as a way to potentially reduce turnaround times, and several devices based on capillary blood draws have achieved commercial translation. However, in comparison to centralized testing, the quantity of available assays remains limited for existing PoC testing, and the accuracy of results obtained with capillary blood remains controversial. Thus there is a significant unmet need for diagnostic tools that combine the breadth and accuracy of traditional laboratory testing with the speed and convenience of PoC devices.
To address these challenges, we have developed a portable robotic device for automated venipuncture that has the potential to improve vein visualization, first-stick accuracy, and completion time independently of patient physiology and practitioner skill. The outcomes of our studies have demonstrated: (1) the device is more readily able to detect peripheral forearm veins compared to one trained phlebotomist, especially in patients with comparatively difficult demographic profiles, and (2) high cannulation accuracies and low completion times can be achieved on a phantom model.
Imaging of veins and robotics for cannulation
Venous Pro uses 3D near infrared optical imaging to visualize peripheral veins
In the image of veins being identified, we allowed the phlebotomist to utilize visual and tactile techniques to find veins. In the majority of cases, the phlebotomist identified the median cubital vein in the antecubital fossa as the primary target for blood draws, and veins along the anterior lower forearm for IV infusions. Currently, the device suggests a cannulation target based on an aggregated score of various image features and displays the decision on the touchscreen interface in an overlay of the real time video. The clinician can either agree with the decision or select an alternative site of cannulation. Improving the decision model to incorporate higher-level information, such as vein structure and anatomical prior knowledge, may allow the device to more closely replicate the deductive reasoning of the clinician. Near Infrared Light (NIR), particularly at 940nm, was observed to significantly improve the detection of peripheral upper limb veins compared to visible light. In our most recent prototypes, we have dramatically enhanced our imaging and robotic capabilities. This enhanced device operates in real-time, combining near-infrared and ultrasound imaging, image analysis, and a 7-Degree-of-Freedom (DOF) robotic system to perform the venipuncture. The robotic device consists of a 3-DOF gantry to image the patient’s peripheral forearm veins, and a 4-DOF serial arm to guide the cannula into the selected vein under closed loop kinematic controls.
VascuLogic, Inc.
Rendering of the Vasculogic VenousPro device
VascuLogic is a medical device development company located in Piscataway, NJ and the creator of VenousPro Automatic Venipuncture Robot based on Dr. Yarmush’s original concepts. The reasoning behind Vasculogic is that automated phlebotomy offers several key advantages over the current gold standard; these advantages include improving vein visualization for higher first-stick accuracy, mitigating clinical variability and human error, and increasing workflow. As an automated system, the device can furthermore enhance practitioner safety by minimizing the chance of needle-stick injury and associated blood-borne infections.
VascuLogic is a company dedicated to generating and commercializing patented image-guided medical and biotechnology devices. The overall goal of the company is to establish their products and services as the preeminent technological substitute for human based procedures. Their initial and primary technology, the VenousProTM is a robotically-driven, automated venipuncture device that allows for first attempt venous access across age, ethnicity, gender, and BMI, and especially aids in cases of difficult venous access (such as in cases of infants and the elderly). In their early stage proof of concept studies, the company has achieved greater than 99% success in rapid and effective venous access.
Relevant publications
Chen A, Balter M, Nikitczuk K, Nikitzuk J, Maguire T, Yarmush ML. Portable robot for autonomous peripheral venous access using 3D near infrared image guidance. Technology. 2013 Nov;1(1):72-80
Chen A, Balter M, Maguire T, Yarmush ML. Evaluation of a portable image-guided robotic device for autonomous venipuncture on customized multi-layered tissue phantoms. IEEE Transactions on Biomedical Engineering, 2014 (under review)
Ghodbane M, Kulesa A, Yu H, Maguire T, Schloss R, Ramachandran, et al. Development of a low volume, highly sensitive microimmunoassay using computational fluid dynamics driven multi-objective optimization. Microfluidics and Nanofluidics, 2014 (under review)
Karabacak NM, Spuhler PS, Fachin F, Lim EJ, Pai V, Ozkumur E, et al. Microfluidic, marker-free isolation of circulating tumor cells from blood samples. Nat Protoc. 2014 Mar;9(3):694-710. PubMed PMID: 24577360; PubMed Central PMCID: PMC4179254
| Martin L. Yarmush, MD, PhD | Timothy Maguire, PhD | |
| [email protected] | [email protected] | |
| 617-371-4882 |