Design, fabrication, and evaluation of 3-D-printed cystotomy spoons as a retrieval method in dogs.

OBJECTIVE: Current cystotomy methods often implement the use of off-label devices, resulting in urocystolith extraction difficulty and potentially leading to postoperative complications and discomfort for the patient. The objective of this study was to create 3 novel 3-D printed cystotomy spoons that offer a dedicated solution for removing urocystoliths from a patient's urinary bladder. ANIMALS: Clinical use of the 3 novel 3-D printed cystotomy spoons were ultimately evaluated in 4 dogs and 1 cat that presented for urocystotlith removal at 3 different veterinary hospitals in northwest Arkansas. METHODS: The novel cystotomy spoons were designed using SolidWorks, 3-D printed with a Dental Surgical Guide resin, and underwent prototype testing that included chlorhexidine soaking, autoclave sterilization, 3-point bend testing, and Finite Element Analysis. The efficiency of the spoons was then evaluated through a limited proof-of-concept study utilizing a postoperative questionnaire for the participating clinicians. RESULTS: Practitioner feedback indicated positive experiences using 1 or more of the novel 3-D printed cystotomy spoons while performing a cystotomy surgery. However, successful use of the spoons was ultimately limited to dogs in the 23 to 34 kg weight range. CLINICAL RELEVANCE: Novel 3-D printed cystotomy spoons have the potential to mediate urocystolith extraction difficulty and reduce postoperative complications. Additionally, this research demonstrates how veterinarians might develop custom 3-D models and prints to meet patient-specific needs. As such, further development could impact the standard of healthcare and the veterinary industry by promoting the use of additive manufacturing in veterinary medicine.

In Vitro Blood Clot Formation and Dissolution for Testing New Stroke-Treatment Devices.

Strokes are among the leading causes of death worldwide. Ischemic stroke, due to plaque or other buildup blocking blood flow to the brain, is the most common type. Although ischemic stroke is treatable, current methods have severe shortcomings with high mortality rates. Clot retrieval devices, for example, can result in physically damaged vessels and death. This study aims to create blood clots that are representative of those found in vivo and demonstrate a new method of removing them. Static blood clots were formed using a 9:1 ratio of whole sheep blood and 2.45% calcium chloride solution. This mixture was heated in a water bath at 37 °C for approximately one hour until solidified. Following clot solidification, human plasmin was introduced by various methods, including soaking, injection, and membrane perfusion, and the resulting dissolution percentages were determined. Different clot types, representative of the wide range found physiologically, were also manufactured and their dissolution characteristics evaluated. A method to reproducibly create blood clots, characteristic of those found in vivo, is essential for the production of stroke retrieval devices that can efficiently and effectively remove clots from patients with low mortality rates and little/no damage to the surrounding vessels.

Critical Information from High Fidelity Arterial and Venous Pressure Waveforms During Anesthesia and Hemorrhage.

PURPOSE: Peripheral venous pressure (PVP) waveform analysis is a novel, minimally invasive, and inexpensive method of measuring intravascular volume changes. A porcine cohort was studied to determine how venous and arterial pressure waveforms change due to inhaled and infused anesthetics and acute hemorrhage. METHODS: Venous and arterial pressure waveforms were continuously collected, while each pig was under general anesthesia, by inserting Millar catheters into a neighboring peripheral artery and vein. The anesthetic was varied from inhaled to infused, then the pig underwent a controlled hemorrhage. Pearson correlation coefficients between the power of the venous and arterial pressure waveforms at each pig's heart rate frequency were calculated for each variation in the anesthetic, as well as before and after hemorrhage. An analysis of variance (ANOVA) test was computed to determine the significance in changes of the venous pressure waveform means caused by each variation. RESULTS: The Pearson correlation coefficients between venous and arterial waveforms decreased as anesthetic dosage increased. In an opposing fashion, the correlation coefficients increased as hemorrhage occurred. CONCLUSION: Anesthetics and hemorrhage alter venous pressure waveforms in distinctly different ways, making it critical for researchers and clinicians to consider these confounding variables when utilizing pressure waveforms. Further work needs to be done to determine how best to integrate PVP waveforms into clinical decision-making.

Customizable Angioplasty Balloon-Forming Machine: Towards Precision Medicine in Coronary Bifurcation Lesion Interventions.

The ability to customize the size and shape of angioplasty balloons may be useful in many clinical and research applications of coronary and endovascular intervention. Fully customizable balloons are outside the reach of most researchers due to their prohibitive cost. A small-scale balloon-forming machine was developed to produce fully customizable balloons. This study describes the creation of this customizable balloon-forming machine and identifies the key components of manufacturing a patient-specific balloon. Using a standard balloon-shaped mold created with a novel application of 3D stereolithography-printed resin, 104 PET balloon formation tests were conducted. A statistical study was conducted in which molding temperature and inflation air pressure were independent variables ranging from 100 to 130 °C and from 3.7 to 6.8 atm, respectively. The criteria for balloon-forming success were defined; pressure and temperature combined were found to have a significant impact on the success (p = 0.011), with 120 °C and 4.76 atm resulting in the highest chance for success based on a regression model.

In Vitro Mitral Valve Model with Unrestricted Ventricular Access: Using Vacuum to Close the Valve and Enable Static Trans-Mitral Pressure.

Current in vitro models of the left heart establish the pressure difference required to close the mitral valve by sealing and pressurizing the ventricular side of the valve, limiting important access to the subvalvular apparatus. This paper describes and evaluates a system that establishes physiological pressure differences across the valve using vacuum on the atrial side. The subvalvular apparatus is open to atmospheric pressure and accessible by tools and sensors, establishing a novel technique for experimentation on atrioventricular valves. Porcine mitral valves were excised and closed by vacuum within the atrial chamber. Images were used to document and analyze closure of the leaflets. Papillary muscle force and regurgitant flow rate were measured to be 4.07 N at 120 mmHg and approximately 12.1 ml/s respectively, both of which are within clinically relevant ranges. The relative ease of these measurements demonstrates the usefulness of improved ventricular access at peak pressure/force closure.

Development of Custom Wall-Less Cardiovascular Flow Phantoms with Tissue-Mimicking Gel.

PURPOSE: Flow phantoms are used in experimental settings to aid in the simulation of blood flow. Custom geometries are available, but current phantom materials present issues with degradability and/or mimicking the mechanical properties of human tissue. In this study, a method of fabricating custom wall-less flow phantoms from a tissue-mimicking gel using 3D printed inserts is developed. METHODS: A 3D blood vessel geometry example of a bifurcated artery model was 3D printed in polyvinyl alcohol, embedded in tissue-mimicking gel, and subsequently dissolved to create a phantom. Uniaxial compression testing was performed to determine the Young's moduli of the five gel types. Angle-independent, ultrasound-based imaging modalities, Vector Flow Imaging (VFI) and Blood Speckle Imaging (BSI), were utilized for flow visualization of a straight channel phantom. RESULTS: A wall-less phantom of the bifurcated artery was fabricated with minimal bubbles and continuous flow demonstrated. Additionally, flow was visualized through a straight channel phantom by VFI and BSI. The available gel types are suitable for mimicking a variety of tissue types, including cardiac tissue and blood vessels. CONCLUSION: Custom, tissue-mimicking flow phantoms can be fabricated using the developed methodology and have potential for use in a variety of applications, including ultrasound-based imaging methods. This is the first reported use of BSI with an in vitro flow phantom.

The Sinotubular Junction-to-Aortic Annulus Ratio as a Determinant of Supravalvar Aortic Stenosis Severity.

Supravalvar aortic stenosis (SVAS) severity guides management, including decisions for surgery. Physiologic and technical factors limit the determination of SVAS severity by Doppler echocardiography and cardiac catheterization in Williams syndrome (WS). We hypothesized SVAS severity could be determined by the sinotubular junction-to-aortic annulus ratio (STJ:An). We reviewed all preintervention echocardiograms in patients with WS with SVAS cared for at our center. We measured STJ, An, peak and mean Doppler gradients, and calculated STJ:An. We created 2 mean gradient prediction models. Model 1 used the simplified Bernoulli's equation, and model 2 used computational fluid dynamics (CFD). We compared STJ:An to Doppler-derived and CFD gradients. We reviewed catheterization gradients and the waveforms and analyzed gradient variability. We analyzed 168 echocardiograms in 54 children (58% male, median age at scan 1.2 years, interquartile range [IQR] 0.5 to 3.6, median echocardiograms 2, IQR 1 to 4). Median SVAS peak Doppler gradient was 24 mm Hg (IQR 14 to 46.5). Median SVAS mean Doppler gradient was 11 mm Hg (IQR 6 to 21). Median STJ:An was 0.76 (IQR 0.63 to 0.84). Model 1 underpredicted clinical gradients. Model 2 correlated well with STJ:An through all severity ranges and demonstrated increased pressure recovery distance with decreased STJ:An. The median potential variability in catheterization-derived gradients in a given patient was 14.5 mm Hg (IQR 7.5 to 19.3). SVAS severity in WS can be accurately assessed using STJ:An. CFD predicts clinical data well through all SVAS severity levels. STJ:An is independent of physiologic state and has fewer technical limitations than Doppler echocardiography and catheterization. STJ:An could augment traditional methods in guiding surgical management decisions.

High resolution imaging of the mitral valve in the natural state with 7 Tesla MRI.

Imaging techniques of the mitral valve have improved tremendously during the last decade, but challenges persist. The delicate changes in annulus shape and papillary muscle position throughout the cardiac cycle have significant impact on the stress distribution in the leaflets and chords, thus preservation of anatomically accurate positioning is critical. The aim of this study was to develop an in vitro method and apparatus for obtaining high-resolution 3D MRI images of porcine mitral valves in both the diastolic and systolic configurations with physiologically appropriate annular shape, papillary muscle positions and orientations, specific to the heart from which the valve was harvested. Positioning and mounting was achieved through novel, customized mounting hardware consisting of papillary muscle and annulus holders with geometries determined via pre-mortem ultrasonic intra-valve measurements. A semi-automatic process was developed and employed to tailor Computer Aided Design models of the holders used to mount the valve. All valve mounting hardware was 3D printed using a stereolithographic printer, and the material of all fasteners used were brass for MRI compatibility. The mounted valves were placed within a clear acrylic case, capable of holding a zero-pressure and pressurized liquid bath of a MRI-compatible fluid. Obtaining images from the valve submerged in liquid fluid mimics the natural environment surrounding the valve, avoiding artefacts due to tissue surface tension mismatch and gravitational impact on tissue shape when not neutrally buoyant. Fluid pressure was supplied by reservoirs held at differing elevations and monitored and controlled to within ±1mmHg to ensure that the valves remained steady. The valves were scanned in a 7 Tesla MRI system providing a voxel resolution of at least 80µm. The systematic approach produced 3D datasets of high quality which, when combined with physiologically accurate positioning by the apparatus, can serve as an important input for validated computational models.