Smart Devices for Peripheral Intravenous Catheterization

Peripheral intravenous catheterization (PIVC) is a medical procedure performed to create access to the venous system of patients. It is frequently required in hospitals, with over one billion operations performed each year worldwide.  

The PIVC operation is very difficult and characterized by very low success rates, especially for pediatrics or special patients. On average, only 53% of PIVCs on pediatric patients are successful on the first attempt, and about 10% of them require more than 4 attempts. Multiple needle insertions are painful and can lead to serious injuries and complications. Successful PIVC requires advanced techniques and medical expertise that normally takes years to acquire.

Our technologies eliminate these problems by allowing even non-experts to successfully perform PIVCs on challenging patients (like newborns).

The key enabling technology integrated in our smart PIVC devices is bioimpedance sensing. This is performed on the catheterization needle tip, allowing precise detection of venipuncture. This sensing system provides robust and highly accurate information. In fact, it demonstrated 100% accuracy during in-vivo trials.

SVEI - Smart Venous Entry Indicator

SVEI is designed to overcome the challenge of venipuncture detection. It is capable of fast and accurate venous entry detection, and lights an LED to inform the operator at the exact moment this happens. This provides a key feedback to the operator, leading to hugely improved success rates of the catheterization operations. Pre-clinical trials on a baby arm phantom demonstrated an increase in success rate for naïve operators from 12% to 86% when using SVEI.

CathBot – A hand-held robotic catheterization device

CathBot not only integrates a sensor on the catheterization needle tip to precisely detect venipuncture, but also includes a smart actuation module able to: 1) automatically stop the insertion motion of the catheterization needle inside the blood vessel, 2) insert the catheter and 3) retract the needle. All of these actions are performed under direct control of the medical operator, whose sole actions are simplified to the task of aiming at the target vessel and pushing the device towards it.

CathBot’s mechanism provides a very simple, comfortable and safe way to operate PIVC with accurate catheter insertion control. The medical operator just needs to push the handle of CathBot towards the target vein, and CathBot can automatically insert the cannula into the vein and retract the needle. CathBot can be used to achieve PIVC on flexible insertion sites.

Related publications: 

1. Mattos, L., Cheng, Z., Davies, B., Caldwell, D., “Hand-held device for assistive venous catheterization,” Italian Patent Application IT 102017000059659 (PT170362), International Patent Application PCT/EP2018/063871, May 31, 2017.
2. Zhuoqi Cheng, Brian L. Davies, Darwin G. Caldwell, and Leonardo S. Mattos. “A hand-held robot for precise and safe PIVC,” IEEE Robotics and Automation Letters (RA-L), vol. 4(2), pp. 655-661, ISSN: 2377-3766, https://doi.org/10.1109/LRA.2019.2892380, April 2019.
3. Cheng, Z., Davies, B., Caldwell, D., Mattos, L., “A new venous entry detection method based on electrical bio-impedance sensing,” Annals of Biomedical Engineering, pp. 1–10, https://doi.org/10.1007/s10439-018-2025-7, April 2018.
4. Cheng, Z., Davies, B., Caldwell, D., Barresi, G., Xu, Q., Mattos, L., “A hand-held robotic device for peripheral intravenous catheterization,” Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, Vol. 231, Issue 12, pp. 1165–1177, http://dx.doi.org/10.1177/0954411917737328, September 2017.
5. Cheng, Z., Davies, B., Caldwell, D., Mattos, L., “A handheld robot for pediatric PIVC: Device design and preclinical trial,” Journal of Medical Robotics Research, Vol. 3, Issue 2, http://dx.doi.org/10.1142/S2424905X18400032, September 2017.
6. Cheng, Z., Davies, B., Caldwell, D., Mattos, L., “A hand-held robot for safe and automatic PIVC,” Hamlyn Symposium on Medical Robotics, pp. 135-136, June 2018.
7. Cheng, Z., Davies, B., Caldwell, D., Mattos, L., “SDOP: A smart handheld device for over-puncture prevention during pediatric peripheral intravenous catheterization,” International Symposium on Medical Robotics, Atlanta, USA, https://doi.org/10.1109/ISMR.2018.8333283, March 1 – 3, 2018.
8. Cheng, Z., Davies, B., Caldwell, D., Mattos, L., “SAID: a Semi-Autonomous Intravenous access Device for pediatric peripheral intravenous catheterization,” Hamlyn Symposium on Medical Robotics, June 2017.
9. Cheng, Z., Davies, B., Caldwell, D., Mattos, L., “A venipuncture detection system for robot-assisted intravenous catheterization,” Proceedings of the 6th IEEE RAS/EMBS International Conference on Biomedical Robotics and Biomechatronics (BioRob 2016), pp. 80-86, Singapore, https://doi.org/10.1109/BIOROB.2016.7523602, June 26-29, 2016.