BSD Medical (Salt Lake City) said it has filed a patent for a new non-invasive phased array breast treatment applicator developed to selectively heat breast cancer tumors. This capability is uniquely applicable to the 915 MHz operating frequency of the BSD-500 hyperthermia system, Hyrum Mead, CEO of BSD Medical, told Medical Device Daily.

"We have a system that delivers precisely-focused microwave energy to bring cancer up to therapeutic temperature — to heat it up to a therapeutic temperature," Mead said.

The company discovered through research that at 915 MHz the characteristics of breast tumors 4-5 centimeters in diameter (those typically treated with radiation and/or chemotherapy) selectively absorb microwave energy, while the microwaves largely pass through the other tissues of the breast, Mead said. The discovery of this selective heating capability could be used in numerous ways for better delivery of hyperthermia in treating breast cancer. However, one of the new applications is to use selective heating of breast tumors to release tiny heat-triggered capsules of chemotherapy drugs as they enter breast tumors through the blood stream, causing the capsules to burst inside the tumor, greatly multiplying the potency of the drug delivery, according to the company. In this case the breast applicator would serve as the "targeting system" to find and heat tumors and the heat-triggered drug capsules would become "smart bombs" that release when heated as they enter the tumor.

"Other than the fact that it allows chemotherapy to be delivered far more efficiently and directly, it also allows the system to be used with radiation therapy," Mead said.

Duke University (Durham, North Carolina) is already using BSD Medical's hyperthermia equipment to release chemotherapy drugs delivered in heat-triggered capsules, and one of the reasons for this new applicator development was to further support Duke's research already under way. This method of providing chemotherapy thus far has shown the ability to deliver 30 times more drug than would normally reach the tumor site with non-encapsulated drug, according to BSD Medical. In addition to releasing the chemotherapy capsules, heat (hyperthermia) therapy makes the tumor's blood vessels porous so that the capsules can pass from the bloodstream into the tumor. Hyperthermia also increases oxygen levels within tumors, and oxygen is critical to the proper functioning of certain chemotherapy agents. Hyperthermia also amplifies the level of genetic damage that chemotherapy inflicts on cells by inhibiting enzymes that normally repair the damage.

Breast cancer tumors that reach a diameter of 4 centimeters or larger are commonly treated by radical breast removal, the company noted. An important objective of this effort is to provide less invasive alternatives for treatment, it said.

In other patent-related news:

• CryoLife (Kennesaw, Georgia), a biomaterials, medical device, and tissue processing company, said it has been awarded a patent for BioFoam, a protein hydrogel foam for rapidly filling and sealing open wounds.

Scientists at CryoLife invented and developed this product as a hemostatic agent and tissue and organ sealant. CryoLife is continuing to develop BioFoam as an organ and tissue sealant. Other applications the company may explore include vascular sealing and tissue augmentation, it said.

Additionally, CryoLife has received funds from the U.S. Department of Defense (DOD), as part of its battlefield trauma program, for the development of protein hydrogel as a product to limit blood loss in soldiers injured in battle.

"When we began developing BioFoam, we quickly realized the many potential life-saving uses this product could have," said Steven Anderson, CryoLife president/CEO. "The granting of the patent validates our technology leadership, reflects our history of innovation and protects our intellectual property."

BioFoam contains an expansion agent and rapidly fills wounds when dispensed, the company said. It is easily applied and could potentially be used intraoperatively to control internal organ hemorrhage, limit blood loss, reduce the need for future operations, as well as to seal open wounds to improve outcomes in penetrating abdominal and chest injury. BioFoam is based on the same technology platform as the BioGlue Surgical Adhesive, a CryoLife product approved by the FDA to control bleeding as an adjunct to sutures and staples in open surgical repair of large vessels.

• Visicu (Baltimore), a healthcare information technology and clinical solutions company focused on critical care, said that the pending reexamination of its patent, filed by iMDSoft (Boston), has concluded successfully with 26 claims being allowed. The Visicu patent describes and claims a system and method for providing continuous, expert network critical care services from remote locations.

According to Visicu, the U.S. Patent and Trademark Office (USPTO) has concluded that the iMDSoft patent does not anticipate any of the claims of the company patent and in fact does not do automated processing of patient data as does the Visicu system. The 26 claims of the patent have each been differentiated from the many cited references in two separate reexaminations. The USPTO concluded that all of Visicu's claims, with clarifying amendments, are allowable over these references. The USPTO's action on the claims reaffirms Visicu's novel approach of centrally monitoring ICUs and determining when intervention is warranted, the company said.

More than 180 hospitals use Visicu's eICU Program featuring high fidelity telemedicine and proprietary early warning and intervention software, the company noted. Visicu says it is the first company to receive such U.S. patent protection and the first to bring remote critical care (eICU centers) to the marketplace.

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