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Colon Grasping Device
From its inception several years ago, Endoscape has carried out a methodical search for and subsequent development of a simple and low cost solutions (Insertion Accessory Devices) for solving the technical difficulties of a deep colon intubation, that is, deployment of a flexible tubular instrument (an endoscope or a lavage tube) all the way to the cecum.
These disposable device solutions, Colon Grasping Devices, are designed to allow an operator to engage, and actively manipulate and pleat the patient¡¯s colon without causing trauma to the colon and enable the use of a new deployment method different from the present, forcible insertion method of a flexible endoscope, which frequently causes episodes of severe discomfort.
Characteristics of the Colon Grasping Devices ¡¤ Provides variable engagement force sufficient for manipulating the colon ¡¤ Disposable, easy and safe-to-use accessory ¡¤ Actively engage the colon with engagement force spread over a large area ¡¤ Weighs less than a few grams (primary component) and no moving parts ¡¤ Low cost
Regulatory Profile of Insertion Accessory Devices in Korea and the US ¡¤ Clearance based on predicate devices (e.g., 510(k)) ¡¤ Only scientific test data (no animal/clinical data) needed for proof of safety and efficacy ¡¤ Product sterilization optional
Colon Intubation: Insertion of a Flexible Tubular Instrument
To perform a colonoscopy or colon lavage, it is necessary to insert into the colon a flexible tubular instrument, be it endoscope or lavage tube, until the tip of instrument reaches the cecum, the deepest part of colon where the small intestine joins the colon.
Until today there has been only one way to accomplish this and that is to push the instrument from outside the patient while employing a complex set of maneuvers to navigate the instrument through the tortuousness of the colon in its native disposition in the pelvic and abdominal cavities.
With a means, such as the Colon Grasping Device, for engaging and manipulating the colon, an operator can now choose to pull and pleat the pliable and mobile colon over the instrument shaft, in effect, brining the tip of the instrument closer to the cecum without having to advance the instrument by pushing.
This highly intuitive technique helps ease or sometimes eliminate the numerous bends in the colon making many of the conventional intubation maneuvers for dealing with the tortuousness of the colon not as critical as before.
Combination of pleating and pushing techniques has rapidly become the standard practice in the Small Bowel Enteroscopy since the fairly recent introduction of the Balloon assisted enteroscopy and later, Spiral enteroscopy making active pleating of the small bowel for the first time.
Despite known technical shortcomings, such as slippage of the engagement device with respect to the bowel wall, these devices and ¡°Push and Pull¡± Enteroscopy techniques made it possible to reach the depth in the small bowel not readily accessible with the conventional Push Enteroscopy.
Unfortunately, attempts to employ these devices and techniques to facilitate the colon intubation have not been very successful. One of the reasons for the failure is believed to be the non-uniform geometry of the colon making the engagement between the engagement device and the colon wall even weaker than in the small bowel.
Products for a ¡°Push and Pull¡± Colonoscopy that are effective and easy to use are yet to reach the market.
Endoscape has been pioneering a number of ground-breaking endoscope technologies, which will profoundly alter how endoscopic procedures are performed in today¡¯s typical endoscopy suites with potentially wide ranging ramifications on practice efficiency, quality of patient care and clinical outcomes. Please see here for the latest information. |
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