Originally Published EMDM May/June 2002
SPECIAL REPORT
Surgical Equipment, Instruments, and Supplies
Thermal Cautery Unit Model 150
A surgical device coagulates small bleeders during outpatient procedures
The Geiger Thermal Cautery Unit (TCU) is a surgical device designed to coagulate small bleeders and to destroy lesions by applying high levels of heat via a wire. The device is used primarily in an outpatient setting by dermatologists, plastic surgeons, veterinarians, general and family practitioners, ENTs, and ophthalmologists.
The device uses a single handpiece connector (versus two in the company's previous model) and a single, easily cleaned, flexible multiple-wire cable. The ergonomics of the reusable handpiece were improved with grip grooves in the area of hand contact, an activation button that is tall enough to function with ill-fitting gloves and that is placed and shaped for maximum comfort. The handpiece is also balanced to compensate for the stainless-steel shroud that covers the distal end.
One of the project's design challenges involved the tremendous level of heat generated at the electrode site during procedures and the high current levels passing through the activation switch. The thermal cautery electrode is mounted in the hand-piece; at full power, the electrode tip attains 2200°F. During lengthy procedures, heat migrates toward the handheld portion of the device. In the original design, internal components would begin to self-destruct as the temperature rose. The current passing through the switch is more than 10 A, and, if not properly designed, the failure rates would be unacceptable. The handpiece also must be capable of withstanding multiple autoclave cycles.
To overcome these issues, high-melt-temperature plastics were employed, a stainless-steel shroud was added to dissipate heat away from the handheld button area, and custom silver contacts were added to the switch. A warning label was also added to the handpiece to warn against extended, uninterrupted use. The result is a vast reduction in the number of handpiece failures. Geiger Medical Technologies Inc., Monarch Beach, CA, USA; 3gen LLC, Dana Point, CA, USA; and Translite, Sugarland, TX, USA.
Treon Treatment Guidance System
A navigation system guides surgical instruments
The Treon is a navigation system that is used in the operating room (OR) by neurologic and orthopaedic surgeons to guide their surgical instruments. The system imports a patient scan (such as MRI or CT data) and translates it into a 3-D map of the patient. During surgery, it displays the location of the surgeon's instrument superimposed on the patient data. The system uses an optical localizer to track the instruments and the patient in concert, displaying the results on a high-resolution flat-panel display.
The mobile stand-alone viewing component enables the user to cost-effectively view images in several ORs, and to view electronic imagery immediately adjacent to the OR table instead of peering across the room at static images on film hanging on a lightbox.
The use of an 18-in. high-resolution flat-panel touch screen and the design of the mounting arm to enable a large range of positioning possibilities provide glare-free viewing for the surgeon and all other OR personnel. The touch screen is very lightweight (compared with a conventional monitor) and can be extended to the surgeon in the sterile field for ergonomic viewing and direct system control. The extension of the arm also enables the rest of the system to be positioned away from the OR table, which is critical because space is of the utmost importance. The ability to use a sterile stylus to control the touch screen eliminates the need to place a sterile drape over the screen, which would cause a degradation in image quality.
The optical-camera support arm is multijointed and extremely flexible. Its large reach means that the base can be positioned conveniently, then the camera can be swung into the optimal position or repositioned as necessary throughout the procedure. A new design of the camera arm's "wrist" joint provides multiple positioning possibilities. MPE Inc., Milwaukee, WI, USA, and Medtronic SNT, Louisville, CO, USA.
UltraCision Harmonic Scalpel Generator 300
An advanced surgical system is used for soft-tissue incisions
The UltraCision Harmonic Scalpel Generator 300 is the second generation of Ethicon Endo-Surgery's harmonic scalpel generator product line. It is used for surgical procedures in which soft-tissue incisions will be made and in which bleeding control and minimal lateral thermal damage to tissue are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels.
The harmonic scalpel uses ultrasonic technology, an energy form that allows both cutting and coagulation at the point of impact. When compared with electrosurgery, fewer instrument exchanges are needed, less tissue charring and desiccation occur, and visibility in the surgical field is improved.
The system consists of a generator, a handpiece with a connecting cable, an instrument end effector (specific types include blade or shears), a foot pedal, and a hand-switching adaptor that mounts on the hand piece. The generator is a high-frequency–switching DSP-controlled, power supply that drives the acoustic system in the handpiece. The transducer, located in the handpiece, consists of piezoelectric ceramics that expand, contract, and convert the electrical energy from the generator into mechanical vibration. The ultrasonic vibration is transmitted from the transducer through an extending rod that acts as an acoustic waveguide to the instrument end effector, which is used to cut and coagulate soft tissue. Nominal longitudinal displacement at the end effector is in the range of 50 to 100 µm, depending on the type of instrument, and is a function of power level. Plexus Technology Group Inc., Neenah, WI, USA; and Ethicon Endo-Surgery, Cincinnati, OH, USA.
ESD Flexible Endoscopic Suturing Device
An endoscopic device enables suturing of gastrointestinal tissue through existing body orifices
The ESD flexible endoscopic suturing device provides surgeons and physicians with a minimally invasive solution for closing gastrointestinal wounds through existing body orifices. Facilitating beneficial therapeutic intervention with minimal discomfort, this supple, flexible product enables the closure of wound sites that would otherwise be inaccessible without violating the integrity of the patient's digestive tract, skin, or other protective structures. The device is suited for use on sites within 70 cm of the mouth or anus, and does not require general anaesthesia or leave painful secondary wounds. Enabling novel procedures, the ESD device also may reduce the need for postoperative patient medication and speeds the conversion of existing surgical procedures to minimally invasive techniques.
Packaged in a sterile blister tray, the ESD device kit consists of an external accessory channel, a Sew-Right suture-delivery device, and a Ti-Knot crimper. Constructed of a two-layer plastic tube with wire mesh, the accessory channel ensures secure endoscope attachment. As only the distal tip of the channel is fixed to the gastroscope, the channel also enhances steering by allowing movement relative to the rest of the scope. The automated Sew-Right device is used to control the specialized needles that traverse the wound tissue and pick up the suture ends. A vacuum mechanism integrated into this component eliminates the problems associated with remote tissue positioning and holding. When the wound has been approximated by suture, the Ti-Knot mechanism installs a metal crimp and cuts away suture tails. LSI Solutions, Victor, NY, USA.
CBYON Suite
Surgeons can visualize internal anatomical structures that are beyond or behind their direct field of view
The CBYON Suite converts 2-D radiological images into a 3-D volumetric model of a patient's unique anatomy, called the Virtual Patient. The Virtual Patient can be viewed from the perspective of surgical instruments to enable enhanced visual understanding of a patient's internal anatomy. Via dynamic data filtering, surgeons can make the Virtual Patient's anatomical structures transparent to target pathology and avoid critical structures. During presurgical planning, the surgeon can perform virtual surgery on the Virtual Patient. During the actual intervention, instrument location and perspective are displayed on the same Virtual Patient images. This enables visual exposure to the targeted pathology and critical structures even before an incision is made. In the postoperative phase, CBYON Suite and the Virtual Patient can be used to verify the results of the surgical procedure and provide the necessary new baseline used in recurring-disease cases.
Traditionally, to see anything deeper than the current incision, the surgeon must rely on CT/MR and fluoroscopic images. Although radiologists are experts in reviewing these images, surgeons typically are not. Surgeons operate in a three-dimensional world, and the radiology images contain 2-D slices of that three-dimensional world. This requires the surgeon to use the 2-D slices to recreate a 3-D patient in their mind's eye. To solve this problem, the Virtual Patient is capable of generating medical-quality images in near real time. By creating a software-driven solution, CBYON Suite offers 15-Hz (frames per second) image updates. This solution allows surgeons interactivity and reduces the product price to one that is more easily acceptable to medical facilities.
A benefit of the software-based design is the ability to upgrade the system by adding application modules. This allows the hospital to purchase a system for use in neurosurgery departments and to convert it for use in ENT surgery units without purchasing another system. CBYON Inc., Palo Alto, CA, USA.
Copyright ©2002 European Medical Device Manufacturer
