The researchers demonstrated the effectiveness of the technology using healthy volunteers with different weights who assumed different positions.
The University of Texas at Arlington has patented a smart seat cushion that uses changes in air pressure to redistribute body weight and help prevent the painful ulcers caused by sitting for long periods of time in a wheelchair.
The same technology can be used to create prosthetic liners that adapt their shape to accommodate changes in body volume during the day and maintain a comfortable fit for the prosthesis. Poor prosthetic fit can cause skin damage and create sores in the residual limb of the wearer.
“Pressure ulcers caused by long periods of sitting without relieving pressure at boney regions such as the tailbone, frequently occur in people who spend significant amount of time on wheelchairs. In the case of prosthesis users, poor fitting of the prosthesis leads to pressure injuries for amputees that can severely affect their daily life,” says Muthu Wijesundara, co-inventor of the technology and chief research scientist at UTA’s Research Institute or UTARI.
“Our technology improves on existing solutions by including real-time pressure monitoring and automated pressure modulation capabilities to help combat the formation of pressure ulcers or sores.”
When a person sits on the cushion, a network of sensors generates a pressure map and identifies vulnerable areas where pressure relief is needed. Automated pressure modulation uses this data to reconfigure the seat cushion surface to offload and redistribute pressure from sensitive areas. Additionally, the seat cushion periodically changes the pressure profile to eliminate pressure buildup over time.
The researchers demonstrated the effectiveness of the technology using healthy volunteers with different weights who assumed different positions: leaning forward, backward, to the left or right. In all cases, the seat cushion measured the pressure immediately and automatically performed an effective pressure redistribution to offload pressure from sensitive areas.
“This technology has multitude of applications in biomedical fields,” Wijesundara notes. “We really feel that it shows great promise in helping patients and their caregivers avoid the pain of stress ulcers and sores.”
Mickey McCabe, director of UTARI, congratulated the UTA team on the recent patent issue.
“UTA’s Research Institute has the mission of taking inventions out of the lab and making them useful to society,” McCabe says. “This patented technology will do precisely that, helping patients avoid added trauma and reducing the burden of costs associated with ulcers and sores on the healthcare system. A real win-win for all sides."
Solvay’s Ixef PARA enables Intelligent Implant Systems for a medical device, a single-use instrument kit for anterior cervical fusion.
Alpharetta, Georgia – Solvay’s high stiffness, strength, gamma sterilization resistance, and biocompatibility of its Ixef polyarylamide (PARA) resin helped enable a new single-use instrument kit for anterior cervical fusion procedures. Developed by Intelligent Implant Systems, a medical device company specializing in solutions for spinal surgery, the MEDIANT Anterior Cervical Plating System leverages Solvay’s advanced polymer to help boost operating room (OR) efficiency, eliminate onsite sterile processing and reduce infection risk.
“The primary benefit of Solvay’s Ixef PARA in this application is its metal-like strength, which gives our single-use surgical instruments a very high level of performance without incurring the costs associated with machining metal and repeated steam sterilization,” notes Marc Richelsoph, president and CEO of Intelligent Implant Systems. “Although PEI also offered viable options for our surgical tool kit, we specified Ixef GS-1022 PARA because its superior stiffness and moldability was essential for the kit’s instruments.”
Ixef GS-1022 PARA forms the awl and pin-screwdriver handles, measuring caliper, and locking plier handles in Intelligent Implant Systems’ kit. The polymer’s excellent impact resistance also eliminated the need for a metal strike plate that had been part of the awl’s early designs. This reduced the cost and simplified the manufacture and assembly of the instrument, further supporting the economics of single-use instruments.
Ixef GS-1022 PARA provides excellent aesthetics, including an attractive surface finish. The material is available in a range of gamma-stabilized colors, including the signature green of the Mediant System’s tools. Together, these properties of Ixef PARA ensure Intelligent Implant Systems’ single-use instruments retain their visual appeal after they are gamma sterilized and packaged for delivery. Solvay’s PARA polymer has been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which helped streamline the Mediant kit’s navigation through regulatory approvals.
“Solvay was an early advocate of the healthcare industry’s shift toward single-use surgical instruments, and we sought to support customers by proactively developing a broad portfolio of biocompatible polymer alternatives to metal – complete with gamma-sterilized colors and master access files,” says Jeff Hrivnak, business manager for healthcare at Solvay’s Specialty Polymers Global Business Unit. “Yet while the industry’s growing adoption of our advanced polymers validates this early insight, we derive much greater satisfaction in working closely with innovators like Intelligent Implant Systems to help achieve unique new designs for improving patient results.”
Veterinarians removed a large cancerous tumor growing on a dachshund’s skull and replaced it with a 3D printed custom implant that fit in place like a puzzle piece.
When the University of Guelph's Ontario Veterinary College’s Dr. Michelle Oblak used a 3D printed custom titanium plate for surgery on a dog’s skull, the procedure not only marked a veterinary first in North America, but it also signaled a potential new breakthrough in cancer research.
In a difficult surgical procedure, Oblak and Cornell small-animal surgeon Dr. Galina Hayes removed a large cancerous tumor growing on a dachshund’s skull and replaced it with a 3D printed custom implant that fit in place like a puzzle piece.
“The technology has grown so quickly, and to be able to offer this incredible, customized, state-of-the-art plate in one of our canine patients was really amazing,” says Oblak, assistant co-director of the U of G’s Institute for Comparative Cancer Investigation and board-certified veterinary surgical oncologist at OVC.
In her translational research, Oblak is examining dogs as a disease model for cancer in humans. She studies use of digital rapid prototyping for advance planning for surgeries and 3D printed implants for reconstruction, using U of G’s rapid prototyping of patient-specific implants for dogs (RaPPID) working group.
Watch a video to learn more about the procedure.
Oblak performed the surgery on the dachshund, named Patches, at Cornell’s College of Veterinary Medicine with Hayes, a former OVC colleague. Hayes had asked Oblak for advice on how best to treat the dog’s tumor, a multilobular osteochondrosarcoma that had grown so large that it was weighing down the dog’s head and growing into her skull, pushing dangerously close to her brain and eye socket.
Dr. Michelle Oblak and Cornell small-animal surgeon Dr. Galina Hayes removed a large cancerous tumor growing on a Patches’ skull and replaced it with a 3D printed custom.
Working with the RaPPID team at OVC, Oblak mapped the tumor’s location and size. She worked with an engineer from Sheridan College’s Centre for Advanced Manufacturing Design and Technologies to create a 3D model of the dog’s head and tumor so she could “virtually” perform the surgery and see what would be left behind once the growth was removed.
I was able to do the surgery before I even walked into the operating room,” says Oblak, holding the small 3D printed model of Patches’ skull with a detachable model of the tumor.
Once she could determine the dimensions of the portion of skull she’d need to replace, she worked with ADEISS, a 3D medical printing company in London, Ont., to adapt software designed for human medicine. Together they created a skull plate to replace the part she planned to remove from Patches’ head.
Typically, she says, surgeries of this kind take a long time. Once the portion of skull is removed, surgeons must assess the damage and shape titanium mesh over the spot. The 3D printed plate fit into place perfectly. For these surgeries, said Oblak, the technique will eliminate the need to model an implant in the operating room and reduce patient risk by shortening the time spent under anesthesia.
Read more about how titanium mesh is used in surgeries to protect dogs’ brains.
Oblak and Hayes had to replace about 70% of the top surface of the dog’s skull, which left the brain unprotected over a large area.
“She was asleep for about five hours, and within about half an hour after surgery, Patches was alert and looking around. It was amazing,” Oblak notes.
“This is major for tumor reconstruction in many places on the head, limb prosthesis, developmental deformities after fractures and other traumas,” says Oblak, adding that she sees tremendous potential for 3D printed implant technology to be transferred to humans. “In human medicine, there is a lag in use of the available technology while regulations catch up. By performing these procedures in our animal patients, we can provide valuable information that can be used to show the value and safety of these implants for humans. These implants are the next big leap in personalized medicine that allows for every element of an individual’s medical care to be specifically tailored to their particular needs.”
Oblak and the U of G team can offer the surgery and customized skull plate through a veterinarian’s referral to the OVC Health Sciences Centre. Animals diagnosed with a skull tumor must be evaluated by a veterinary surgeon and have a CT scan performed to determine eligibility for this procedure.
US FDA approvals, mergers & acquisitions, funding, research & development and more medical device design and manufacturing news you may have missed.
Leica Microsystems received 510(k) clearance from the U.S. FDA to market its Augmented Reality GLOW800 surgical fluorescence for vascular neurosurgery (pictured above). In combination with ICG (Indocyanine Green), GLOW800 allows surgeons to observe cerebral anatomy in natural color, augmented by real-time vascular flow in a single image, with full depth perception. This augmented reality solution provides the surgeon a complete view of anatomy and physiology to support crucial decisions and actions during vascular neurosurgery.
GLOW800 AR fluorescence is the first of many imaging modalities that will be based on the GLOW AR platform from Leica Microsystems. GLOW AR modalities can be fully integrated in the ARveo digital augmented reality microscope which launched earlier this year. Following the FDA 510(k) clearance of GLOW800, ARveo customers in the US can now experience the full advantages of augmented reality visualization in the operating room.
Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluvia drug-eluting vascular stent system, specifically developed for the treatment of peripheral artery disease (PAD). The Eluvia stent uses a drug-polymer combination to offer sustained release of the drug paclitaxel for a one-year timeframe, designed to prevent tissue regrowth that might otherwise block the stented artery.
(Left) Cook Medical's 5mm diameter Zilver PTX drug-eluting stent.
Cook Medical’s a new 5mm diameter version of Zilver PTX was approved by the U.S. FDA. It is the first 5mm drug-eluting stent in the U.S. with lengths available up to 140mm that is indicated to treat vessels as small as 4mm in diameter. The range of Zilver PTX stent diameters now available will address treatment of vessel sizes from 4mm to 7mm in diameter. The new diameter is better sized for smaller anatomy than previous sizes of the stent and provides an additional option to treat patients with lesions in their superficial femoral arteries (SFAs).
TransEnterix Inc., a medical device company digitizing the interface between surgeons and patients to improve minimally invasive surgery (MIS), has acquired substantially all of the assets of MST Medical Surgery Technologies Ltd., an Israel-based medical technology company, in a cash and stock transaction. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning, and data analytics.
The addition of MST's technology, IP portfolio, and R&D team supports and accelerates TransEnterix's vision to leverage its Senhance Surgical System to deliver digital laparoscopy, increasing control in the surgical environment and reducing surgical variability.
OrthoXel's Apex Femoral Nailing System has been granted US FDA 510(k) clearance, following regulatory clearances and first clinical implantations of the Apex Tibial Nailing System earlier this year. The Apex Femoral Nailing System features a modern anatomic nail curvature in a universal nail that can be surgically implanted from antegrade or retrograde orientations with a dedicated instrumentation kit. The system offers a comprehensive suite of versatile multiple-trajectory locking options including OrthoXel micromotion for controlled axial movement with exceptional torsional stability to promote callus formation. Additional locking options include recon and rigid interlocking for unstable proximal femoral fractures.
The U.S. Food and Drug Administration has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.
The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program, funded by Congressional appropriations and encourages clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases. The grants are intended for clinical studies evaluating the safety and effectiveness of products that could either result in, or substantially contribute to, the FDA approval of products targeted to the treatment of rare diseases. Grant applications were reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts, which included representatives from academia, the National Institutes of Health and the FDA.
The grant recipients, principal investigators and approximate funding amounts, listed alphabetically, are: Alkeus Pharmaceuticals Inc. (Cambridge, Massachusetts), Leonide Saad, phase 2 study of ALK-001 for the treatment of Stargardt disease – $1.75 million over four years
Arizona State University-Tempe Campus (Tempe, Arizona), Keith Lindor, phase 2 study of oral vancomycin for the treatment of primary sclerosing cholangitis – $2 million over four years
Cedars-Sinai Medical Center (Los Angeles), Shlomo Melmed, phase 2 study of seliciclib for the treatment of Cushing disease – $2 million over four years
Columbia University of New York (New York), Yvonne Saenger, phase 1 study of talimogene laherparepvec for the treatment for advanced pancreatic cancer – $750,000 over three years
Emory University (Atlanta), Eric Sorscher, phase 1/ 2 study of Ad/PNP fludarabine for the treatment of head and neck squamous cell carcinoma – $1.5 million over three years
Fibrocell Technologies Inc. (Exton, Pennsylvania), John Maslowski, phase 1/2 study of gene-modified ex-vivo autologous fibroblasts for the treatment of dystrophic epidermolysis bullosa – $1.5 million over four years
Johns Hopkins University (Baltimore), Amy Dezern, phase 1/2 study of CD8-reduced T cells for the treatment of myelodysplastic syndrome or acute myeloid leukemia – $750,000 over three years
Oncolmmune Inc. (Rockville, Maryland) Yang Liu, phase 2b study of CD24Fc for the prevention of graft versus host disease – $2 million over four years
Patagonia Pharmaceuticals, LLC (Woodcliff Lake, New Jersey), Zachary Rome, phase 2 study of PAT-001 (isotretinoin) for the treatment of congenital ichthyosis – $1.5 million over three years
The General Hospital Corporation (Boston), Stephanie Seminara, phase 2 study of kisspeptin for the treatment of dopamine agonist intolerant hyperprolactinemia – $1.4 million over four years
University of Minnesota (Minneapolis), Kyriakie Sarafoglou, phase 2a study of subcutaneous hydrocortisone infusion pump for the treatment of congenital adrenal hyperplasia – $1.4 million over three years
University of North Carolina at Chapel Hill (Chapel Hill, North Carolina), Matthew Laughon, phase 2 study of sildenafil for the prevention of bronchopulmonary dysplasia – $2 million over four years
BD uses Carbon’s Digital Light Synthesis technology for part prototyping, production; optimizing the manufacturing process to increase print speed by 55% and reducing resin usage by 7%.
Becton, Dickinson and Company (BD) has long recognized the potential of additive manufacturing (AM) for its applications. The company identified products struggling with part geometries or economies of scale with both injection molding and milling, and initiated a program to examine additive processes, materials, and companies claiming to meet demanding medical applications.
The Advanced Prototyping, Corporate Computer-Aided Engineering (CAE) team led by Larry Monahan in Research Triangle Park, North Carolina, tasked Carbon with the goal of accelerating product development throughout various business units. The engineering groups within each BD business unit would then use the parts to rapidly iterate on new designs and test the function of the printed parts.
The BD team soon proved that the Carbon technology could be useful for prototyping through production. This case study examines how they identified an ideal application for additive manufacturing and why they ultimately selected Carbon and MPU 100 for production.
The BD Rhapsody single-cell analysis system (pictured above)
In mid-2017, the corporate CAE team began providing parts to the BD Life Sciences – Genomics group based in Menlo Park, California. The BD Genomics team was building a single-cell genomic analysis system that makes it possible to understand cellular form and function on the basis of individual cells. Traditional assays such as microarrays and bulk RNA sequencing, which take an average of measurements across multiple cells, hide subtle differences between individual cells. The BD Rhapsody system overcomes this limitation and makes it possible to identify and characterize rare cell types, allowing researchers to understand biological processes in fields ranging from immunology to oncology.
The product development challenge A critical component of this product is the hemocytometer adapter, which integrates a fluidic microwell component into an optical system. The fabricated holder must accommodate the dimensions and operational requirements of both a fluidic “slide” and the existing imaging technology.
Part design requirements The key design requirements for this part were the sliding surfaces and the central fluidics holder, which required flush surfaces to fit with the other components in the assembly. Other key features included trapped negative space for the slide holder, undercut structures, and a window for optics.
Desired Process Improvements For this component, injection molding and milling were inherently limited with respect to:
As a result, BD viewed additive manufacturing as a potential solution. The right additive process had to deliver cost and speed benefits without compromising on the part’s design requirements.
A decision for Digital Light Synthesis BD chose Carbon’s technology for these key reasons:
Monahan mentions, “We worked closely with the Carbon team to leverage the biocompatibility and sterilization data already generated for MPU 100 material. Then we partnered with BD’s toxicology group to generate our own internal data.”
BD stores this data in an internal database so that engineers across the organization can identify which materials are appropriate for a given application.
The first prints for the hemocytometer adapter were a success, but it was clear that the part’s printability could be significantly improved through a redesign that leveraged Carbon’s process.
Optimizing the design for Digital Light Synthesis Jamie Cone, an engineer on the Corporate CAE team, worked closely with Carbon to improve throughput and reduce the cost per unit by optimizing the part for production.
Conclusion With the combination of Carbon technology and service, the hemocytometer adapter for the BD Rhapsody single-cell genomic analysis system will be BD’s first production part using additive manufacturing. This project offered BD a cost-effective solution to address difficult to mold geometries without sacrificing part quality. By transitioning this part to a digital manufacturing process, BD could iterate at will, integrating feedback from Carbon to improve their product and optimize the manufacturing process to increase print speed by 55% and reduce resin usage by 7%.