Imagine your religious beliefs laid between you and your life.
This is what happened in mid-April to Julie Penoyer, a 50-year-old U.K. heart patient and Jahovah’s Witness. Following her religious beliefs, her request when undergoing open-heart surgery was to not receive donated blood products. Without the ability to receive blood transfusions, doctors needed another way to transfer blood back to the patient’s body that could potentially save her life in case of blood spillage. Lucky for those surgeons, and Penoyer, Brightwake Ltd. developed a blood recycling machine, called Hemosep, using Stratasys’ Dimension 1200es 3-D printer.
The Hemosep recovers blood spilled during open-heart and major trauma surgery, concentrating the blood cells ready for transfusion back into the patient. This process, known as autotransfusion, reduces the volume of donor blood required and the problems associated with transfusion reaction. The prototype device features a number of Stratasys 3-D printed parts, including the main filtration and cooling systems, enabling the Brightwake team to functionally test the system in its intended environment, before the final device is produced from metal.
The device has been awarded the CE mark and is attracting global interest from distributors and health care providers. Successful clinical trials of over 100 open-heart surgery operations in Turkey confirmed the Hemosep’s ability to significantly reduce the need for bloods transfusions, and further trials are continuing in the U.K.
Penoyer was one of the first patients to benefit from the Hemosep device in U.K. trials. As the device captures, cleans and puts back lost blood from an operation, the Hemosep was the perfect solution for her and her beliefs. This solidified Hemosep as an option for patients across the globe whose religious beliefs mean receiving donated blood isn’t an option.
So why use Stratasys’ Dimension 3-D printer in the prototyping of the Hemosep?
“If you look at the device itself, what you will see is it contains and utilizes many different materials,” says Andy Middleton, GM and SVP, Stratasys EMEA, Germany. “For the Hemosep to be perfectly prototyped, it needed a technology which could first be extremely accurate and repeatable and second, able to print a variety of materials to simulate the final product."
“While the device is simple in what it does, it’s actually quite complex in its construction," says Middleton. The device consists of many different parts generated from the Dimension 3-D printer from many different materials ranging from heavy-duty plastics to metals.
The Dimension 1200 is a 3-D printer that uses fused deposition modeling (FDM) technology which takes raw materials, like an ABS-like plastic with great characteristics in terms of strength, repeatability and accuracy, and layer-by-layer sinters the material in a select CAD-derived image layout.
Not only was the printer sought for its broad materials, but it also was sought to help slash prototyping costs of the device. “It took the cost down about 96%,” says Middleton.
“What the company previously did was outsource their prototyping to different companies and have long lead times,” says Middleton. “If there was a revision needed, they would have to go through the whole process again—outsourcing, getting quotes, etc.”
The future of 3-D printing in medical devices
The adoption of 3-D printing has accelerated over the past few years with a growth rate of 30 to 50% year over year. And while medical is just one field 3-D printing is making a splash in, the technique and machines allow companies the ability to build from idea, to product concept design, to a functional prototype much faster and more accurately then previous traditional prototyping methods.
In the medical industry, apart from the standard requirement for prototyping parts, devices or instruments, Stratasys is making big inroads and introduced a new 3-D printer in the dental area. According to Middleton this will not only usher in a new option for the dental industry, it will become the standard for prototyping and developing dental products and devices. The company is working with their suppliers for integral scanners which allow, in the dental world, for digital production of either crowns, bridges or veneers. Middleton also notes that Stratasys’ 3-D printing technology will also be used for surgical guides, which will reduce patient time in the seat and make the whole experience of getting dental surgery more pleasant. Not to mention it will provide a cost-effective solution.
Stratasys is also looking at surgical planning, where their 3-D printer technology can take scan data or CT data from a head scan or MRI scan and flow that into a 1:1 model, a solid part or a visualized part of a patient, so that the surgeon can practice on the model with a high degree of confidence before they actually operate on the patient on the operation table. “This benefits a much higher success rate and much less time for the patient on the operating table,” says Middleton. “So that is one area we are going to put even more evidence to.”
FDA approval is of utmost importance for medical devices, this even applies to the prototyping process. Stratasys has received FDA approval on many of their materials that can prolong contact with human tissue, which will open new applications that the industry doesn’t even know of today. “It could be a surgical guide to allow more precise operations,” says Middleton. “It could influence precision drilling.” The more biomaterials that can be 3-D printed, the greater the scope for the industry. The sky is the limit.