Development and Characterization of an Ex Vivo Testing Platform for Evaluating Automated Central Vascular Access Device Performance

Boice, Emily N.; Berard, David; Torres, Sofia I. Hernandez; Avital, Guy; Snider, Eric J.

doi:10.3390/jpm12081287

Cited by 3 publications

(1 citation statement)

References 14 publications

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“…Swine tissue was utilized due to the similarities between human and swine femoral vessels [40][41][42]. Using previously developed methodologies [43], we cannulated the distal superficial femoral artery using a 14G catheter (MedOfficeDirect, Naples, FL, USA). Proximal cannulations for both vessels were made using 8Fr PCI introducers (Argon Medical Devices, Athens, TX, USA) and secured using silk ligatures.…”

Section: Ex Vivo Swine Model Setupmentioning

confidence: 99%

Toward Smart, Automated Junctional Tourniquets—AI Models to Interpret Vessel Occlusion at Physiological Pressure Points

Avital,

Hernandez Torres,

Knowlton

et al. 2024

Bioengineering

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Hemorrhage is the leading cause of preventable death in both civilian and military medicine. Junctional hemorrhages are especially difficult to manage since traditional tourniquet placement is often not possible. Ultrasound can be used to visualize and guide the caretaker to apply pressure at physiological pressure points to stop hemorrhage. However, this process is technically challenging, requiring the vessel to be properly positioned over rigid boney surfaces and applying sufficient pressure to maintain proper occlusion. As a first step toward automating this life-saving intervention, we demonstrate an artificial intelligence algorithm that classifies a vessel as patent or occluded, which can guide a user to apply the appropriate pressure required to stop flow. Neural network models were trained using images captured from a custom tissue-mimicking phantom and an ex vivo swine model of the inguinal region, as pressure was applied using an ultrasound probe with and without color Doppler overlays. Using these images, we developed an image classification algorithm suitable for the determination of patency or occlusion in an ultrasound image containing color Doppler overlay. Separate AI models for both test platforms were able to accurately detect occlusion status in test-image sets to more than 93% accuracy. In conclusion, this methodology can be utilized for guiding and monitoring proper vessel occlusion, which, when combined with automated actuation and other AI models, can allow for automated junctional tourniquet application.

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Section: Ex Vivo Swine Model Setupmentioning

confidence: 99%

Toward Smart, Automated Junctional Tourniquets—AI Models to Interpret Vessel Occlusion at Physiological Pressure Points

Avital,

Hernandez Torres,

Knowlton

et al. 2024

Bioengineering

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Evaluation of a Semi-Automated Ultrasound Guidance System for Central Vascular Access

Hernandez Torres,

Caldwell,

Snider

2024

Bioengineering

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Hemorrhage remains a leading cause of death in both military and civilian trauma settings. Oftentimes, the control and treatment of hemorrhage requires central vascular access and well-trained medical personnel. Automated technology is being developed that can lower the skill threshold for life-saving interventions. Here, we conduct independent evaluation testing of one such device, the Vu-Path™ Ultrasound Guidance system, or Vu-Path™. The device was designed to simplify needle insertion using a needle holder that ensures the needle is within the ultrasound field of view during its insertion into tissue, along with guidance lines shown on the user interface. We evaluated the performance of this device in a range of laboratory, animal, and human testing platforms. Overall, the device had a high success rate, achieving an 83% insertion accuracy in live animal testing across both normal and hypotensive blood pressures. Vu-Path™ was faster than manual, ultrasound-guided needle insertion and was nearly 1.5 times quicker for arterial and 2.3 times quicker for venous access. Human usability feedback highlighted that 80% of the participants would use this device for central line placement. Study users noted that the guidance lines and small form factor were useful design features. However, issues were raised regarding the needle insertion angle being too steep, with potential positioning challenges as the needle remains fixed to the ultrasound probe. Regardless, 75% of the participants believed that personnel with any level of clinical background could use the device for central vascular access. Overall, Vu-Path™ performed well across a range of testing situations, and potential design improvements were noted. With adjustments to the device, central vascular access can be made more accessible on battlefields in the future.

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Development of a Modular Tissue Phantom for Evaluating Vascular Access Devices

et al. 2022

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Central vascular access (CVA) may be critical for trauma care and stabilizing the casualty. However, it requires skilled personnel, often unavailable during remote medical situations and combat casualty care scenarios. Automated CVA medical devices have the potential to make life-saving therapeutics available in these resource-limited scenarios, but they must be properly designed. Unfortunately, currently available tissue phantoms are inadequate for this use, resulting in delayed product development. Here, we present a tissue phantom that is modular in design, allowing for adjustable flow rate, circulating fluid pressure, vessel diameter, and vessel positions. The phantom consists of a gelatin cast using a 3D-printed mold with inserts representing vessels and bone locations. These removable inserts allow for tubing insertion which can mimic normal and hypovolemic flow, as well as pressure and vessel diameters. Trauma to the vessel wall is assessed using quantification of leak rates from the tubing after removal from the model. Lastly, the phantom can be adjusted to swine or human anatomy, including modeling the entire neurovascular bundle. Overall, this model can better recreate severe hypovolemic trauma cases and subject variability than commercial CVA trainers and may potentially accelerate automated CVA device development.

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Development and Characterization of an Ex Vivo Testing Platform for Evaluating Automated Central Vascular Access Device Performance

Cited by 3 publications

References 14 publications

Toward Smart, Automated Junctional Tourniquets—AI Models to Interpret Vessel Occlusion at Physiological Pressure Points

Toward Smart, Automated Junctional Tourniquets—AI Models to Interpret Vessel Occlusion at Physiological Pressure Points

Evaluation of a Semi-Automated Ultrasound Guidance System for Central Vascular Access

Development of a Modular Tissue Phantom for Evaluating Vascular Access Devices

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