A Proof-of-Concept Demonstration for a Novel Soft Ventricular Assist Device
Patients treated by current ventricular assist devices (VADs) suffer from various post implantation complications including gastrointestinal bleeding and arteriovenous malformation. These issues are related to intrinsically mismatch of generated flow by VADs and the physiological flow. In addition, the common primary drawback of available VADs is excessive surgical dissection during implantation, which limits these devices to less morbid patients. We investigated an alternative soft VAD (SVAD) system that generates physiological flow, and designed to be implanted using minimally invasive surgery by leveraging soft material...
Source: Journal of Medical Devices, Transactions of the ASME - April 16, 2019 Category: Medical Devices Source Type: research

Water Jet Applicator for Interface Tissue Removal in Minimally Invasive Hip Refixation: Testing the Principle and Design of Prototype
We describe the requirements for a waterjet applicator for interface tissue removal for this percutaneous hip refixation technique. The technical requirements were either obtained from a literature review, a theoretical analysis, or by experimental setup. Based on the requirements, a waterjet applicator is designed which is basically a flexible tube (outer diameter 3  mm) with two channels. One channel for the water supply (diameter 0.9 mm) and one for suction to evacuate water and morcellated interface tissue from the periprosthetic cavity. The applicator has a rigid tip (length 6 mm), which directs the water flow t...
Source: Journal of Medical Devices, Transactions of the ASME - April 16, 2019 Category: Medical Devices Source Type: research

An Electronic Force Sensor for Medical Jet Injection
In medical jet injection, a narrow fluid drug stream is propelled at high velocity into skin without a needle. Previous studies have shown that the volume delivered is highly dependent on a number of factors. This paper details the development of an electronic force sensor for medical jet injection and shows that the normal contact force exerted on the tissue by the nozzle is an additional factor affecting volume delivered. Using this sensor, we measure the forces at the nozzle tip in the normal direction with a sensitivity of 18  μN, calibrated over a range from 1  N to 8 N with a mean absolute error of 8 mN, and...
Source: Journal of Medical Devices, Transactions of the ASME - April 11, 2019 Category: Medical Devices Source Type: research

Measurement of Frictional Properties of Aortic Stent Grafts and Their Delivery Systems
The objective of this study was to determine the coefficients of friction of three commercially available stent grafts (Cook Zenith, Medtronic Endurant, and Vascutek Anaconda), their delivery sheaths, a porcine aorta, and two mock arterial materials. Stent grafts were obtained and separated into stents, graft fabric, and sheaths. Using a custom-made friction measurement apparatus, the coefficients of friction were measured between five material pairs: (i) the stents and inner surface of the sheath, (ii) the graft fabric and inner surface of the sheath, (iii) the outer surface of the sheath and a porcine aorta, (iv) the out...
Source: Journal of Medical Devices, Transactions of the ASME - April 11, 2019 Category: Medical Devices Source Type: research

Design and Modeling of a Three-Degree-of-Freedom Articulating Robotic Microsurgical Forceps for Trans-Oral Laser Microsurgery
Trans-oral laser microsurgery (TLM) is a surgical procedure for removing malignancies (e.g., cysts, polyps, tumors) of the laryngeal region through laser ablation. Intraoperative microsurgical forceps (i.e., microforceps) are used for tissue manipulation. The microforceps are rigid, single degree-of-freedom (DOF) devices (open –close) with precurved jaws to access different parts of the curved cylindrical laryngeal region. These microforceps are manually handled and are subject to hand tremors, poor reachability, and nonergonomic use, resulting in poor efficacy and efficiency in the surgery. A novel 3DOF motorized micro ...
Source: Journal of Medical Devices, Transactions of the ASME - April 4, 2019 Category: Medical Devices Source Type: research

Portable Device for Measuring Blood Test Hemolyzed Samples Based on Computer Vision and Neural Network
Hemolysis is a challenging problem and still represents a frequent source of errors in blood test laboratory practice. Due to the broad and heterogeneous bias induced in the measurement of several parameters by hemolysis, inaccurate results may be reported, and the patient may be required to repeat sample collection, delaying diagnosis. Existing automated laboratory devices including hemolysis detection are not suitable for lower volume and smaller sample collection sites. In many situations, hemolysis is still detected by visual inspection of the sample after centrifugation, during the blood test pre-analytical stage. Vis...
Source: Journal of Medical Devices, Transactions of the ASME - April 4, 2019 Category: Medical Devices Source Type: research

Compact Two Degrees-of-Freedom External Fixator System for Correction of Persistent Clubfoot Deformity
Bone deformities are often complex three-dimensional (3D) deformities, and correcting them is difficult. To correct persistent clubfoot deformity in adolescents or adults, an external fixator is sometimes used to encourage tissue growth and preserve healthy tissues. However, it is difficult to set up, resulting in long surgeries and steep learning curves for surgeons. It is also bulky and obstructs patient mobility. In this paper, we introduce a new approach of defining clubfoot deformity correction as a six degrees-of-freedom (6DOF) correction, and then reducing it to just two degrees-of-freedom (2DOF) using the axis-angl...
Source: Journal of Medical Devices, Transactions of the ASME - April 4, 2019 Category: Medical Devices Source Type: research

Programmable Multistable Mechanisms for Safe Surgical Puncturing
We present novel medical devices for safe surgical puncturing, in particular a cannula for the treatment of retinal vein occlusion (RVO). This passive mechanical device has an adjustable stroke and exerts a puncturing force independent of operator applied displacement. The innovative feature of this tool is that puncturing stroke is decoupled from operator input thereby minimizing the possibility of overpuncturing. This is achieved using our concept of stability programming, where the user modifies the mechanism strain energy as opposed to imposing direct displacement which is the case for standard bistable mechanisms. Ult...
Source: Journal of Medical Devices, Transactions of the ASME - March 21, 2019 Category: Medical Devices Source Type: research

The Role of Tissue Slip Feedback in Robot-Assisted Surgery
We report on a survey of 112 RAS surgeons, the results of which support the value of detecting and reducing slip in a variety of procedures. We conducted validation tests using a thermal slip sensor in a surgical grasper on tissue in vivo and ex vivo. The results of the surve y and validation informed a user study to assess whether tissue slip feedback can improve performance and reduce effort in a phantom tissue manipulation task. With slip feedback, experienced subjects were significantly faster to complete the task, dropped tissue less (3% versus 38%), and experienced decreased mental demands and situational stress. The...
Source: Journal of Medical Devices, Transactions of the ASME - March 21, 2019 Category: Medical Devices Source Type: research

Dynamic Compression Garments for Sensory Processing Disorder Treatment Using Integrated Active Materials
This study demonstrates the viability of SMA-based compression garments as an enabling technology for enhancing SPD (and other compression-based) treatment. (Source: Journal of Medical Devices, Transactions of the ASME)
Source: Journal of Medical Devices, Transactions of the ASME - March 6, 2019 Category: Medical Devices Source Type: research

Value-Based Care: A Review of Key Challenges and Opportunities Relevant to Medical Technology Innovators
Developed countries struggle with high healthcare spending, and cost is often cited as a barrier to the introduction of new patient care technologies. The core objective of this review article is to help familiarize medical technology innovators with trends in the health economic environment and the implications for the adoption of new technologies. We review and discuss this topic in language accessible to medical technology innovators. We assess macrolevel developments in healthcare spending and highlight measures already taken to control spending. We discuss practical implications for anyone involved in healthcare innov...
Source: Journal of Medical Devices, Transactions of the ASME - March 6, 2019 Category: Medical Devices Source Type: research

A Systematic Review of Noninvasive Electrocardiogram Monitoring Devices for the Evaluation of Suspected Cardiovascular Syncope
The aims of this study were (1) to identify research publications studying noninvasive electrocardiogram (ECG) monitoring devices, (2) to define and categorize current technology in noninvasive ECG recording, and (3) to discuss desirable noninvasive recording features for personalized syncope evaluation to guide technological advancement and future studies. We performed a systematic review of the literature that assessed noninvasive ECG-monitoring devices, regardless of the reason for monitoring. We performed an Internet search and corresponded with syncope experts and companies to help identify further eligible products. ...
Source: Journal of Medical Devices, Transactions of the ASME - March 6, 2019 Category: Medical Devices Source Type: research

Percutaneous Ultrasound Gastrostomy: A Novel Device and Bedside Procedure for Gastrostomy Tube Insertion Using Magnetic and Ultrasound Guidance
This paper describes a novel percutaneous ultrasound gastrostomy (PUG) procedure and the CoapTech point-of-care ultrasound magnet-aligned gastrostomy (PUMA-G) device, which were developed to allow the placement of gastrostomy tubes by physicians across a variety of specialties, using ultrasound equipment found in many nonspecialized medical locations while consuming fewer resources. The current practice for the placement of gastrostomy tubes requires highly specialized equipment and trained physicians, which can delay the performance of the procedure or make it inaccessible in some locations. The PUMA-G device consists of ...
Source: Journal of Medical Devices, Transactions of the ASME - March 6, 2019 Category: Medical Devices Source Type: research

A Real-Time Tracking and Visualization System for Robot-Assisted Template Location Method Applied to Lung Cancer Brachytherapy
The objective of this paper is to establish a real-time tracking and visualization system (RTVS) to monitor the robot-assisted location process distantly and confirm the ultimate location accuracy without redundant computed tomography (CT) scans. RTVS consists of tracking and visualization components. A quaternion-based iterative closest point (QICP) algorithm for higher accuracy was proposed for the premised module of spatial registration. Arithmetic accuracy of QICP and clinical performance of RTVS were both validated by a series of experiments in a CT room. Spatial registration experiment shows that QICP consistently pr...
Source: Journal of Medical Devices, Transactions of the ASME - January 31, 2019 Category: Medical Devices Source Type: research

A Robust Incubator to Improve Access to Microbiological Culture in Low Resource Environments
To help address the limitations of operating conventional microbiological culture incubators in low resource environments, a new incubator design was developed and tested to meet the requirements of operation in laboratories without reliable power (power outages up to 12 contiguous hours) or climate control (ambient indoor temperatures from 5  °C to 45 °C). The device is designed to enable adherence to incubation temperatures recommended for growth detection, identification, and drug susceptibility testing (DST) of human pathogenic bacteria. During power outages, stable temperatures are maintained in the device's int...
Source: Journal of Medical Devices, Transactions of the ASME - January 22, 2019 Category: Medical Devices Source Type: research