There is real potential for 3-D printing technology to become a revolutionary tool in reconstructive medicine. Research led by Thomas Boland, Ph.D. at the University of Texas at El Paso points to development of 3-D printed breast implants for cancer patients who’ve undergone lumpectomies.
Lumpectomy surgery leaves healthy parts of the breast intact, but often creates greater challenges to addressing the disfigurement that results than does the more radical complete mastectomy where the entire breast is removed. Dr. Boland observes in a UTEP release that “About 150,000 women a year have lumpectomies due to breast cancer and they have no good option for reconstruction. Sometimes they even opt for the removal of the entire breast because then they can actually have a complete reconstruction – like Angelina Jolie did a few weeks ago.”
However, of the nearly 300,000 women the American Cancer Society projects will be diagnosed with breast cancer in 2013, according to the AARP, up to 75 percent will opt for lumpectomy.
Current methodologies for filling lumpectomy voids include fat grafting, a series of fat injections that may or may not prove successful, with healing further slowed by reabsorption into the body. An alternative is breast reduction and reconstruction, where the healthy breast is reduced in size to match the reconstructed breast in size and shape, or just doing nothing, with consequent deformity and asymmetry.
However, total breast removal and reconstruction is not without its risks. Women who opt for removal of the entire breast may face a immune system response to silicone or saline-filled implants, with symptoms that can include pain, scarring and tissue contraction in which the breast begins to appear abnormal and no longer symmetrical. Saline-filled implants have reportedly been known to rupture in rare instances.
The promise of 3-D printed breast implants is a technique where the patient’s own fat cells, harvested by liposuction, can be treated, printed to the appropriate contours, and fitted in to the lump removal void for implant, combining the advantages of more accurate restoration of appearance and elimination of tissue rejection. “What we’re going to do is take the patient’s very own cells and use them so that there won’t be a foreign body response,” says Dr. Boland,
“We have been investigating a biodegradable hydrogel which is derived from natural proteins and carbohydrates, creating a scaffold to use as a substrate to grow cells,” Dr. Boland is quoted observing. According to his research abstract, this hydrogel is a unique composite of gelatin and alginate, both of which have very high biocompatibility, promoting cells’ growth and vascularization. His HP Deskjet 340 printer uses HP 33 cartridges that have been modified to control temperature and deposition. An aluminum plate adapted to the printer uses the paper feeding sensor and two switches along the y-axis of the machine to evenly distribute the gelatin into the form.
ABC’s El Paso affiliate KVIA has posted a video profiling Dr. Boland’s research at UTEP here:
Biotech startup TeVido BioDevices LLC, the company that currently holds a license agreement with UTEP on Dr. Boland’s patent-pending technology, was formed to transition the research into the commercial space, and is initially working on development of a 3-D printing process that could fabricate breast tissue to be used in breast reconstruction after a lumpectomy. If funding can be secured, TeVido hopes to build several centralized, high-quality manufacturing facilities to produce breast tissue, possibly branching out into nipple reconstruction and breast augmentation using a patient’s own cells.
However, Dr. Boland, who is also co-founder and chief science officer of TeVido Biodevices, believes that 3-D printing technology is capable of printing larger implants as well for patients who have undergone complete mastectomies, repairing other forms of tissue damage, perhaps even someday in restoring part or all of amputated limbs, although more research is needed on printing larger volumes before that can be made a reality. In the future, researchers expect the technology to also be capable of helping patients with severe burns and chronic, non-healing wounds — whose sufferings range from pain, reduced quality of life, loss of productivity, and unsightly scarring, all the way to amputation of part or all of a limb when an ulcer becomes infected and gangrenous. These patients often face multiple surgeries, painful skin grafts, and frequent trips to wound-care clinics. According to TeVido BioDevices, estimates place the annual incidence of chronic wounds at almost 9 million worldwide and expanding due to aging populations, longer life expectancies, and specific increases in the prevalence of diabetes and obesity.
TeVido BioDevices’ CEO and founder Laura Bosworth-Bucher noted to Joe Velarde of University of Texas at El Paso news feed utepnews that “Foot ulcers affect approximately 10 to 15 percent of patients with diabetes throughout their lifetimes, and by 2025, it is estimated that 300 million people will have diabetes.”
Worldwide, wound care products are projected to grow to sales of ~$21B in 2015, with the emerging set of biotechnologies, biomaterials and tissue engineering expected to drive growth and make up ~20% of revenue, >$4B. The reconstructive surgery market (other than breast reconstruction) provides additional product opportunities for TeVido, whose 3-D printing process deposits materials, such as endothelial cells, in exact locations layer by layer. This allows creation of microvasculature channels throughout a skin-based structure. These channels, or capillaries, encourage blood flow and vascularization, a critical step in wound healing and graft “take” rates — qualities that do not exist in current therapies.
Ms. Bosworth-Bucher, who has a BS in Engineering from The University of Texas at El Paso, and over 25 years of cross-functional industry experience, hopes that working in partnership with Dr. Boland and the University of Texas at El Paso (where she is a member of the Advisory Board for UTEPs College of Engineering), she will be able to raise the tens of millions of dollars in funding that will be required for continued research and development of the 3-D printing technique. a third TeVido partner, chief technology officer Scott Collins, has a doctorate in biomedical engineering from the University of Texas at Austin and is also vice president of product development. TeVido has one full-time staff scientist, Maria Yanez.