Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2000-08-22
2002-09-17
Reip, David O. (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S153000, C606S213000, C227S175100
Reexamination Certificate
active
06451029
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to surgical devices and methods, and, more particularly, to such devices and methods for stapling a resected passageway together.
2. Description of Related Art
Low anterior bowel resection is a procedure typically used to treat colon or rectal cancer. One of the most serious complications following this procedure is the development of a leak from the anastomosis, which is the region at which the two cut sections of the passage are joined together end to end. Leaks following the resection of, for example, distal rectal lesions can result in death or at minimum prolonged or permanent colostomy, with great expenditure incurred in additional hospital days and medication.
Despite the known potential complications, little progress has been made in alleviating this problem, as leak rates have remained constant. Leaks may be caused by a number of factors, including poor blood supply, tension, or holes/defects in the staple lines. Currently used stapling devices, such as the Endopath Proximate ILS Curved Intraluminal Stapler, do not permit testing for leaks; rather, the device must be removed and another device such as a rigid proctoscope inserted to permit air insufflation for leak testing.
Another problem associated with such procedures is that the stapling device can be difficult to insert into the anus if the rectal vault has collapsed.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a device that tests an anastomosis for integrity of the joined region.
It is a further object to provide such a device that both staples and performs the leak testing.
It is another object to provide such a device that is insertable into a collapsed orifice.
It is an additional object to provide a method of leak testing an intestinal anastomosis.
It is yet a further object to provide such a method for stapling and leak testing with a common instrument.
It is yet another object to provide such a method for expanding a collapsed orifice to facilitate instrument insertion.
These and other objects are attained with the present invention, a stapler and associated methods for joining resected passageways together and leak testing the anastomosis. The stapler comprises an elongated member having a length sufficient to extend from an area outside a surgical site to a region at the surgical site having two sections of tissue desired to be joined. At the distal end of the elongated member is positioned means for joining the tissue sections together. Means for activating the joining means is positioned adjacent the proximal end.
The elongated member has a lumen extending from adjacent the distal end to adjacent the proximal end. Affixable to an opening at the proximal end of the lumen is means for insufflation for introducing a fluid into the lumen and out through an opening at the distal end of the lumen.
A method of the present invention includes joining two tissue segments together with an instrument and leak testing the anastomosis with the same instrument. A further aspect of the method comprises the step of facilitating the instrument's insertion into a passageway by insufflating the passageway if it is in a collapsed state.
REFERENCES:
patent: 5309927 (1994-05-01), Welch
patent: 5350355 (1994-09-01), Sklar
patent: 5533661 (1996-07-01), Main et al.
Reip David O.
Saliwanchik Lloyd & Saliwanchik
University of South Florida
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