For more than a century, surgeons have envisioned reshaping tissue without the use of scalpels and sutures. Recently, novel lasers and electrical devices have brought this vision closer to reality through the development of new procedures and minimally invasive devices for treating skin and other tissues. In the emerging field of shape change surgery, compelling and innovative results have been reported in the reshaping of frameworks of the face and in skin rejuvenation. Correcting defects in the face and neck that result from trauma, burns, cancer surgery, or birth defects have led to the development of surgical techniques to reshape cartilage in order to restore or recreate damaged or absent structures. Conventional surgery requires carving, crushing, scoring, or suturing cartilage tissue to change its shape, and has many disadvantages including complications from harvesting cartilage grafts, waste of excess graft tissue, incomplete shape change, lack of control over warping (particularly with rib cartilage), and the need for anesthesia, scalpels, and large incisions.

Reshaping living tissues is an emerging area of study, and most techniques rely upon precisely controlled heat generation to soften tissues and remodel tissues such as cartilage. Extensive study of the use of heat-generating lasers by the PI and colleagues at the University of California, Irvine, led directly to a spin-off technology, which we refer to as electromechanical reshaping (EMR), or electroforming. EMR is a novel and patented tissue-reshaping technique that may allow surgeons to bend cartilage into the shape they desire by simply inserting platinum-plated needles, then applying electrical current from a source as common as a disposable battery.

EMR will potentially provide surgeons with a new way to change the shape of cartilage tissue in a much more elegant manner without having to crush, carve, or suture. EMR can be used to reshape cartilage structures in the face (ear, nose) and neck (trachea, voicebox). This is particularly important in combat-related casualties, because the face and neck often go unprotected as body armor covers mainly the chest, abdomen, arms, legs, and skull. These combat related injuries often require total reconstruction of the ear or nose, and to do so, vast amounts of cartilage are needed. Unfortunately, there is little "free" cartilage in the body, and generally what is available is inadequate for total facial reconstruction (e.g., both ears, nose). Ribs harbor massive amounts of cartilage, but most of it warps when cut, and cannot be used for facial reconstruction using conventional methods. EMR may allow surgeons to better tap this vast source of cartilage, and expand its use to rebuild the face. Civilian applications include the correction of deviated septums (septoplasty) ~250,000/year, nasal deformities (rhinoplasty) ~ 300,000/year, protuberant ears (otoplasty) ~present in one in 5,000 births, and correct trachea problems as well (~1% to 8% of critically ill patients). Because EMR is simple to implement, it can be used in endoscopic surgery or minimally invasive techniques that will not require large incisions.

Moving EMR from the lab bench to bedside is a process that begins with the work described in this proposal, as we need to know more about the relationship between shape change, voltage, and time, and how tissue grows and remodels in a living animal. Because the EMR process does not generate any toxic chemical or waste products, does not use radiation, or any biohazards, and therefore is a very low-risk technology, we believe it can be rapidly moved into study in patients. While human studies are not proposed as part of this proposal, we envision starting evaluation in humans within two years after the completion of the studies described here.

The development of EMR technologies to reshape cartilage has potentially immense impact on facial reconstructive surgery. First of all, this method reduces waste of otherwise good cartilage tissue, which may make available the vast costal (rib) cartilage reservoir for reconstruction. EMR is compelling because it potentially stabilizes any new shape even in cartilage specimens that surgeons would deem unacceptable using traditional criteria. Since EMR can be performed using existing hardware already available and batteries purchased anywhere, it is an inexpensive technology to implement, on par with sutures and scalpels. EMR can provide a new means to reshape existing cartilaginous structures in the face as well as reshape costal cartilage tissues that can then be fully exploited to rebuild the face and airway.