Surgery – Endoscope – With guide means for body insertion
Reexamination Certificate
2002-03-08
2004-09-21
Leubecker, John P. (Department: 3739)
Surgery
Endoscope
With guide means for body insertion
C604S526000, C604S527000
Reexamination Certificate
active
06793621
ABSTRACT:
INTRODUCTION
This invention relates to a colonic overtube for maintaining a section of a colon, such as a sigmoid colon, in a straightened configuration.
The lower gastrointestinal tract comprises the rectum, and the large intestine or colon. The colon, in a textbook arrangement of the human anatomy, extends upwards from the lower right quadrant, traverses the width of the body just below the diaphragm, travels downwards along the left side of the abdomen and then loops in an anterior retrograde manner before linking up with the rectum and the anus.
Even in such a textbook arrangement, the large intestine is difficult to cannulate with a colonoscope due to the flexible nature of the colonoscope and the floppy nature of the colon. This is even more difficult with the more realistic anatomies of actual people.
In some people, the sigmoid colon can be very long and is unfixed, except by its mesentery, and so can be extremely difficult to cannulate due to its predisposition to form loops when a colonoscope is pushed through it. Looping of the colonoscope within the sigmoid colon and transverse colon exacerbates the problems in traversing these areas.
Conventional colonoscopy procedures involve advancing a colonoscope through the floppy sigmoid colon to the proximal end of the descending colon. During advancement of the colonoscope through the sigmoid colon loops often form. It is difficult to then advance the colonoscope further, due to the looped nature of the sigmoid colon. Further pushing of the colonoscope simply increases the loops in the sigmoid colon without advancing the colonoscope into the descending colon.
The sigmoid colon is generally straightened by manipulation of the colonoscope. However advancing the colonoscope further, into the descending colon may cause the loops in the floppy sigmoid colon to reform.
It is known to use an overtube to prevent the reformation of loops by splinting the straightened sigmoid colon. The overtube is typically advanced over the colonoscope until the distal end of the overtube is at the proximal end of the descending colon. The overtube then maintains the sigmoid colon in the straightened configuration and prevents loops from reforming in the sigmoid colon during advancement of the colonoscope further, into the descending colon.
However, due to the potentially tortuous path through a colon, it is often difficult to advance an overtube over a colonoscope without kinking of the overtube occurring.
Furthermore, parts of the interior wall of a colon may become trapped between a colonoscope and an overtube during advancement of the overtube over the colonoscope. This may result in shearing off of the trapped part of the colon wall or puncturing of the colon wall.
In addition, in certain colonoscopy procedures, for example multiple polypectomy, it is necessary to insert and remove a colonoscope several times. This requires considerable skill on the part of the colonoscopist and takes a considerable length of time.
This invention is aimed at providing a colonic overtube which overcomes at least some of these problems.
STATEMENTS OF INVENTION
According to the invention there is provided a colonic overtube for maintaining a section of a colon in a straightened configuration, the overtube having a proximal end for location externally of a colon, a distal end for insertion into a colon, and a colonoscope lumen extending therethrough for passing the overtube over a colonoscope;
at least portion of the overtube being laterally flexible to facilitate flexing of the overtube substantially without kinking during advancement of the overtube through a colon.
The laterally flexible nature of the overtube of the invention enables the overtube to advance through a potentially tortuous path in a colon without kinking. This is particularly advantageous when the overtube is being advanced through a sharp bend in the colon, for example when advancing the overtube through the splenic or hepatic flexures or through parts of the sigmoid colon.
In one embodiment of the invention the laterally flexible portion of the overtube extends along the entire length of the overtube.
In another embodiment of the invention the overtube has more than one laterally flexible portion spaced along the overtube.
The laterally flexible portion may be provided by at least one corrugation. Preferably the corrugation extends along the overtube in a convoluted manner.
The corrugation may extend at least partially circumferentially around the overtube.
In a preferred embodiment of the invention the overtube comprises a plurality of corrugations. Ideally the corrugation is provided on an interior surface of the overtube. Most preferably an exterior surface of the overtube is smooth.
In another embodiment of the invention the overtube comprises a coating of a lubricious material.
The overtube may comprise a composite material. Preferably the overtube is of a layered construction. Ideally the overtube comprises a reinforcement means. The reinforcement means may be embedded in the overtube.
In one case the reinforcement means comprises a coil. In another embodiment the reinforcement means comprises a mesh. The reinforcement means may be of a braided construction.
Desirably the reinforcement means is of a metallic material.
In a preferred embodiment of the invention the overtube is of a material which is thermally stable in use. Ideally the overtube is of polytetrafluoroethylene.
In another preferred case the overtube is extendable between a shortened configuration and an elongated configuration for cannulating at least portion of a colon.
The overtube may comprise a flexible seal at the distal end for sealing between the overtube and a colonoscope extending through the colonoscope lumen.
In another aspect of the invention there is provided a colonic overtube for maintaining a section of a colon in a straightened configuration, the overtube having a proximal end for location externally of a colon, and a distal end for insertion into a colon, and a colonoscope lumen extending therethrough for passing the overtube over a colonoscope;
the overtube comprising a flexible seal at the distal end for sealing between the overtube and a colonoscope extending through the colonoscope lumen.
The colonic overtube of the invention has a flexible seal at the distal end of the overtube. The seal ensures that no parts of the colon wall become trapped between the overtube and the colonoscope during advancement of the overtube over the colonoscope. This arrangement prevents shearing off of the trapped part of the colon wall or puncturing of the colon wall.
In some colonoscopy procedures, air or some other gas is used to insufflate the colon, for example to blow a protruding piece of the wall of the colon laterally to clear a path for advancement of the overtube and/or the colonoscope further distally through the colon. A further advantage of the seal is that it prevents insufflation air from leaking proximally out of the colon between the colonoscope and overtube.
In addition the flexible nature of the seal enables the seal to adapt to the size of the colonoscope to achieve an effective seal between the overtube and the colonoscope for a variety of differently sized colonoscopes.
The seal preferably comprises a film material. The seal may comprise a sheath of film material. Ideally the seal comprises an inner sealing layer and an outer sealing layer around the inner sealing layer. Most preferably the seal is mounted to an exterior surface of the overtube. The seal may extend inwardly to seal between the overtube and a colonoscope extending through the colonoscope lumen. Desirably the seal extends distally of the distal end of the overtube.
According to another aspect of the invention there is provided a colonic overtube for maintaining a section of a colon in a straightened configuration, the overtube having a proximal end for location externally of a colon, a distal end for insertion into a colon, and a colonoscope lumen extending therethrough for passing the overtube over a colonoscope;
the overtube being of
Bonadio Frank
Brennan Edmund
Butler John
Gill Aoibheann
Atropos Limited
Leubecker John P.
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