McGowan Institute for Regenerative Medicine
affiliated faculty members Ernest Manders, MD (pictured top), residency program director for the Division of Plastic Surgery, medical director of the Facial Nerve Center, chief of plastic surgery at the Oakland VA Hospital, and plastic surgery chief of the University of Pittsburgh Cranial Base Surgery Program, and David Schwartzman, MD (pictured bottom), professor of medicine at the University of Pittsburgh, member of the UPMC Cardiovascular Institute, and director of the UPMC Atrial Fibrillation Center, were recently awarded U.S. patents for their inventions. Dr. Manders developed a patent for a dimensionally adjustable soft tissue expander for expanding breast skin. Dr. Schwartman is a co-inventor of a device and method of use for functional isolation of heart tissues.
Dr. Manders’ invention is an improved soft tissue expander with an adjustable base which maintains its shape during implantation and expansion so that the size of the expanded overlying skin and soft tissue expanded is determined by the size and shape of the expander base selected by the surgeon before the expander is implanted. A single expander may be used to expand different size areas of skin and soft tissue by adjusting the shape of the base prior to implanting the expander under the skin and soft tissue to be expanded.
An expander according to the invention is useful in expanding skin and soft tissue overlying the breast of the patient prior to implanting a breast prosthesis. This procedure forms a shaped layer of skin and soft tissue conforming to the shape of the breast and having sufficient area to replace the skin removed from the lower pole of the breast during a mastectomy. Accurate shaping of the expanded skin and soft tissue to simulate the natural breast is critically important to the success of the procedure.
The use of an adjustable base expander according to the invention for expanding breast skin and soft tissue permits the surgeon to use one expander for patients having different sized breasts with the base of the expander adjusted before implantation to meet the requirements of the particular patient. The size of the expander base is readily adjusted and does not change during implantation and inflation of the expander and overlying skin and soft tissue. The expander is also useful in other soft tissue expansion procedures.
Dr. Schwartzman is the co-inventor of a device and method of use for functional isolation of animal or human tissues of the heart. Embolic stroke is the nation's third leading killer for adults and a major cause of disability among older Americans. There are over 80,000 strokes per year in the United States alone. A common cause of embolic stroke is thrombus formation in the heart resulting from stagnant blood flow that occurs as a result of atrial fibrillation. Atrial fibrillation ("AF") is an extremely deleterious condition resulting in chaotic cardiac rhythms that typically precipitate lower cardiac output and irregular blood flow in various regions of the heart. There are over 5 million people worldwide with AF and about 400,000 new cases reported each year. Patients with AF are at approximately a 500 percent greater risk of embolic stroke due to the condition. Though pharmacologic treatments of AF are common, they are palliative rather than curative. Furthermore, a patient with AF commonly experiences a significantly decreased quality of life due, in large part, to the fear of a stroke and lifestyle restrictions associated with the attendant pharmaceutical regimen.
Patients with AF often develop thrombus in the left atrial appendage (LAA) of the heart. The LAA is a protrusion which looks like a small finger or windsock extending from the lateral wall of the left atrium between the mitral valve and root of the left pulmonary vein. The interior of the LAA is open to the left atrium allowing blood to flow from the left atrium into the appendage. The physiological function of the LAA is not fully understood. However it is known to be highly innervated indicating that it may have some neurological role. The LAA is also known to secrete substances leading to various theories of its endocrine and/or paracrine nature. Further, the LAA may function as a physical compliance chamber for the left atrium.
Direct surgical and thorascopic techniques have been used to obliterate the LAA. Nonetheless, many patients are unsuitable candidates for such surgical procedures due to a compromised condition (e.g. mitral valve disease) or those having previously undergone cardiac surgery. Furthermore, the perceived risks of even thorascopic surgical procedures often outweigh the potential benefits of this treatment modality.
What has been needed is a less invasive atraumatic method and device for isolating, excluding, closing or occluding a target tissue, body lumen, or appendage. Specifically, it would be desirable to provide an epicardial device and method for containment or elimination of thrombus formation in the LAA of patients with atrial fibrillation. The present invention satisfies these and other needs.
Accordingly, the present invention is directed to devices and methods to capture and isolate tissue. More particularly, this invention relates to devices and methods for selectively capturing, manipulating and isolating, excluding, occluding or ablating a target tissue, lumen or appendage using mechanical, electrical, radiative, chemical, or thermal energies. Preferably, the isolation, exclusion, occlusion or ablation results from a minimally invasive, external action upon the target tissue. For example, if the left atrial appendage were the target, isolation would be accomplished, in accordance with the present invention, by means of pericardial approach, gentle, non-invasive capture of the epicardial surface of the appendage (i.e. the epicardial surface is not penetrated), followed by subsequent isolation. Similarly, if the target tissue is the colonic appendage, the appendage would be accessed, in accordance with the present invention, via peritoneal approach, non-penetrating capture of the serosal surface and subsequent isolation.
A further aspect of the present invention is directed to devices and methods for functional isolation of tissue, by mechanical and/or electrical, radiative, chemical, or thermal means; particularly, isolation of the LAA, preferably by external/epicardial capture, manipulation, stabilization, and attachment of a closure device to the base of the LAA. One purpose of mechanically occluding the orifice between the LAA and the left atrium is to prevent formation within, or passage of embolic material from, the LAA into the left atrium and hence, into the bloodstream of a patient. Entry of these emboli into the patient's blood stream can have deleterious consequences including cerebral stroke.
Illustration: McGowan Institute for Regenerative Medicine.
U.S. Patents Awarded to Inventors in Pennsylvania
Dimensionally adjustable soft tissue expander, Ernest K. Manders
Device and method of use for functional isolation of animal or human tissues, Marco Zenati Marco, David Schwartzman, Mark Gartner, Daniel McKeel
Bio: Dr. Ernest Manders
Bio: Dr. David Schwartzman