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2005 SAGES Abstracts

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EMERGING TECHNOLOGY LUNCH ORAL ABSTRACTS<br />

<strong>SAGES</strong> <strong>2005</strong><br />

and has limited precision of efficacy. Drugs only inhibit acid<br />

production; they do not address the physiologic dysfunction of<br />

the LES. Opportunity remains for a comprehensive treatment<br />

which is minimally invasive, safe and restores the LES to normal<br />

function. Our approach is to correct the LES by providing<br />

an implant to directly augment its function. It is our objective<br />

that this implant provides a precise pressure barrier in the<br />

LES. It is our further objective that the implant can actuate to<br />

allow normal swallow functions.<br />

The technology is an active implant which is attached to the<br />

distal esophagus. The implant provides a barrier to gastric<br />

pressures, yet yields to normal swallow pressures.<br />

At rest the implant provides a compressive resistance to opening<br />

of the esophagus with a magnitude of 10-20mm Hg.<br />

When swallowing, the implant?s resting tone barrier decreases.<br />

This allows the implant to distend to the maximum diameter<br />

of the esophagus and immediately return to the minimum<br />

diameter of the esophagus after the food bolus passes.<br />

The device has been extensively tested in animal studies both<br />

acutely and chronically. All animals have undergone pre- and<br />

post-implant manometry testing which consistently yields an<br />

average 15 mm-Hg pressure increase over baseline.<br />

Fluoroscopically viewed barium swallows were also performed<br />

to verify normal swallow function and device actuations; all<br />

have been normal. Additionally, histopathology assessment<br />

has demonstrated a stable healing process and incorporation<br />

of the implant.<br />

Pre-clinical testing of the device is being completed. The<br />

implant provides a definitive and physiologic increase in pressure<br />

resistance to gastric reflux. To date, data suggests the<br />

implant is safely incorporated to the esophagus and maintains<br />

its position. Additionally, the implant?s function of providing a<br />

gastric pressure barrier and allowing full distention for normal<br />

swallow function appears permanent.<br />

ET005<br />

MULTISPECTRAL THERAPEUTIC ENDOSCOPY—IMAGING<br />

AND INTERVENTION, John L Bala BS, Ronald Franzino MD,<br />

Micro Invasive Technology, Inc.<br />

OBJECTIVES: This paper’s objective is to redefine conventional<br />

endoscopes so that they can efficiently transmit Visible (VIS),<br />

Ultra Violet (UV) and Infrared (IR) images from within the<br />

body, and can guide laser energy into it.<br />

DESCRIPTION: Current endoscopes cannot combine visual<br />

imaging and therapeutic intervention because their light<br />

source is static; their fiber optic bandwidth is limited; and their<br />

optics are inefficient, responding only to light between 400-<br />

700nm. The multispectral endoscope uses Pulsed Xenon<br />

Flashtubes which offer a broad optical spectrum (190-1200nm),<br />

and which generate high-powered micro-second light pulses<br />

that convert non-visible light into visual images. These images<br />

can become visible with the use of photodynamic dyes or IR<br />

Sensors. Multiplexing technology can also direct lasers for<br />

ablation/coagulation by sharing the fiber optic illumination<br />

pathway into the body between intervention and imaging.<br />

Pulsed Xenon’s UV output can directly kill some infectious<br />

bacteria in seconds and also activate diagnostic dyes in situ.<br />

During laser surgery, this technology can also identify thermal<br />

variations in solid tissue temperature; the IR spectrum may be<br />

able to delineate solid tissue from blood vessels as well.<br />

The multispectral endoscope uses optical concepts that<br />

replace up to 22 optical elements with a single component to<br />

increase the transfer efficiency and resolution of visual and IR<br />

images. It can be equipped with different, interchangeable,<br />

low-cost, disposable illuminators which can be optimized for a<br />

given surgical procedure.<br />

RESULTS: Working prototypes of the “Pulsed Xenon Imaging<br />

and Intervention System “ demonstrate the efficacy of multiplexing.<br />

Laboratory tests utilized pulsed UV light to kill<br />

238 http://www.sages.org/<br />

Staphylococcus. In vivo tests demonstrated multiplexing of<br />

lasers with visual imaging. Image-guided intestinal biopsies<br />

using a disposable illuminator multispectral endoscope integrated<br />

with a snare were performed.<br />

CONCLUSIONS/FUTURE DIRECTION: Current results represent<br />

“proof of concept” rather than FDA clinical test requirements.<br />

These results demonstrate the multispectral endoscope’s<br />

potential as a therapeutic surgical imaging device. Integrating<br />

laser targeting with visual imaging will further increase the<br />

capability of both technologies. Multispectral imaging and<br />

intervention, combined with application-based optics, is the<br />

enabling technology for the future of endoscopy.<br />

ET006<br />

NICKEL TITANIUM (NITI) CLIP FOR SIDE-TO-SIDE BOWEL<br />

COMPRESSION ANASTOMOSIS. PRELIMINARY RESULTS IN<br />

HUMANS., Amir Szold MD, Doron Kopelman MD,Shlomo<br />

Lelcuk MD, Tel Aviv Sourasky Medical Center, Ha’emek<br />

Medical Center, Rabin Medical Center<br />

Aim: NiTi is a Shape-memory alloy with unique physical properties.<br />

These properties were used to design a device for sideto-side<br />

bowel anastomosis. After preliminary testing in animals<br />

proved safety and efficacy, and after a feasibility proof of<br />

concept in limited number of humans, the device was first<br />

used in humans over the past year.<br />

Methods: The device consists of a double coil inserted sideways<br />

into the two bowel loops to be anastomosed, through<br />

small incisions. A deployment instrument inserts the device<br />

and creates a small slit between the bowel loops to allow passage<br />

of gas and fluids until the anastomosis is patent. The clip<br />

has memory shape; it is inserted after cooling, allowing<br />

spreading of the coil for easy introduction and after warming<br />

to body temperature it closes over the tissue in constant and<br />

controlled force. During 5-10 days following the procedure the<br />

clip compresses the bowel loops. Pressure necrosis and fibrosis<br />

that take place simultaneously create a healed anastomosis<br />

within that time period, and the device detaches and is<br />

expelled naturally.<br />

Results: Following animal studies the device was used in over<br />

60 patients for the creation of small bowel and large bowel<br />

anastomoses. Following some design adjustments the device<br />

was found to be easy to use, and effective. There were no<br />

adverse effects attributable to the device, and the anastomoses<br />

functioned within 3-6 days following the operation.<br />

Conclusions: The NiTi device was found to be safe and effective.<br />

A large, multi-center is currently undertaken to further<br />

study the use of this side-to-side compression Anastomosis<br />

device.<br />

ET007<br />

DEPLOYMENT & EARLY EXPERIENCE WITH REMOTE PRES-<br />

ENCE ROBOTIC-ASSISTED PATIENT CARE IN A COMMUNITY<br />

HOSPITAL, Joseph B Petelin MD, Jonathan Goodman MD,<br />

Surgix Minimally Invasive Surgery Institute, Univ of Kansas<br />

School of Medicine Dept of Surgery<br />

Introduction: Telemedicine has been discussed for decades.<br />

The widespread implementation of a remote true patientphysician<br />

interaction has awaited useful devices, adequate<br />

communication bandwidth, and protocols that would make it<br />

practical. The introduction of the RP-6? (InTouch Health, Santa<br />

Barbara) remote presence ?robot? appears to be a useful<br />

telemedicine device. The authors describe the deployment and<br />

early experience with the RP-6? in a community hospital, and<br />

provide a live demonstration of the system.<br />

Methods: The RP6? is a 5?4? tall, 215 pound robot that can be<br />

remotely controlled from an appropriately configured computer<br />

located anywhere on the Internet (i.e. this planet). The system<br />

is composed of a control station (a computer), a mechanical<br />

robot, a wireless network (at the home facility—the hospital),<br />

and a high-speed Internet connection at both the home<br />

(hospital) and remote locations. The robot itself houses a<br />

rechargeable power supply. Its hardware and software allows<br />

communication over the Internet with the remote station,<br />

interpretation of commands from the remote station and conversion<br />

of the commands into mechanical and non-mechanical

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