Surgery – Instruments
Reexamination Certificate
2001-08-03
2004-06-15
Leubecker, John P. (Department: 3739)
Surgery
Instruments
C600S124000, C206S363000
Reexamination Certificate
active
06749601
ABSTRACT:
DESCRIPTION OF THE INVENTION
Field of the Invention
The invention relates to an endoscopic surgical instrument. More particularly, the invention relates to a protective sleeve to cover, for example, any potentially damaging protrusions or rough edges on such an instrument, and a related method of using that protective sleeve in an endoscopic procedure.
BACKGROUND OF THE INVENTION
An endoscopic surgical procedure is one of the lesser invasive surgical procedures available to treat many disorders. In an exemplary endoscopic procedure, an endoscope and/or other instruments is inserted into a body lumen, such as, for example, the esophagus. The operator guides the endoscope and instruments through the lumen until they reach the location within the patient where a surgical procedure is to be performed. Once the instruments are in position, the operator uses controls connected to the various instruments, but located outside the patient, to perform the desired procedure.
Some endoscopic procedures involve the introduction of a tube into the body lumen having passages through which other instruments are inserted, thus protecting the patient from any rough edges or protruding portions on those instruments. In other procedures, the instruments may be inserted directly into the body lumen itself. These instruments may include tools such as graspers, cutters, staplers, biopsy devices, etc., that can impinge upon and damage tissue as they are inserted and guided through the lumen to the location of the procedure to be performed.
An exemplary endoscopic procedure treats gastroesophageal reflux disease. Gastroesophageal reflux occurs when stomach acid enters the esophagus. This reflux of acid into the esophagus occurs naturally in healthy individuals, but also may become a pathological condition in others. Effects from gastroesophageal reflux range from mild to severe. Mild effects include heartburn, a burning sensation experienced behind the breastbone. More severe effects include a variety of complications, such as esophageal erosion, esophageal ulcers, esophageal stricture, abnormal epithelium (e.g., Barrett's esophagus), and/or pulmonary aspiration. These various clinical conditions and changes in tissue structure that result from reflux of stomach acid into the esophagus are referred to generally as gastroesophageal reflux disease (GERD).
A surgical procedure has been developed to prevent acid reflux in patients whose normal lower esophageal sphincter functioning has been impaired. This procedure, a Nissen fundoplication, involves bringing the fundus into closer proximity to the esophagus and suturing the fundus thereto, to help close off the esophageal opening into the stomach. Traditionally, this procedure has been performed as an open surgery, but also has been performed laparoscopically and endoscopically.
Less invasive endoscopic treatments of gastroesophageal reflux disease may utilize a remotely operable invagination device and a remotely operable surgical stapler, both of which are inserted transorally through the esophagus. The invagination device may be inserted first and used to clamp the gastroesophageal junction. The device is then moved distally, pulling the clamped gastroesophageal junction into the stomach, thereby invaginating the junction and involuting the surrounding fundic wall. The stapler then may be inserted transorally and delivered to the invaginated junction where it is used to staple the fundic wall. The stapling device must apply sufficient force to pierce the tissue that is to be fastened.
While the stapling device, grasper, and other instruments are often compact, they may contain edges or protrusions that could contact tissue as the device is inserted transorally. As these tools are inserted directly into the esophagus, they may impinge upon tissue and cause damage along the insertion path. Once the procedure has been performed, the same difficulty may be encountered in the removal of the various instruments.
This problem of damaging tissue during instrument insertion applies not only to GERD treatment procedures but also to many other endoscopic surgical procedures. The GERD treatment has been described as an example. Insertion of any endoscopic tool with rough edges or sharp protrusions through a body lumen has the potential for damage to the tissue along the path. Preventing this potential for damage would benefit endoscopic procedures.
SUMMARY OF THE INVENTION
In accordance with an aspect of the invention, a protective sleeve is provided for use with an endoscopic surgical instrument. The protective sleeve includes a flexible tube having an opening at each end of the tube and of a length to cover a desired portion of the surgical instrument. In addition, an elastic ring is provided proximate one end of the tube.
In accordance with another aspect of the invention, the protective sleeve is provided with a perforation running the length of the tube.
In accordance with yet another aspect of the invention, the flexible tube is transparent.
In accordance with another aspect of the invention, the protective sleeve further includes a ring of a fixed diameter located at the opposite end of the tube from the elastic band. In addition, a circumferential perforation is provided at the end of the tube with the fixed diameter ring.
In accordance with another aspect of the invention, the protective sleeve further includes a second elastic ring located opposite the first elastic ring.
In accordance with another aspect of the invention, the sleeve is folded in on itself and a third ring is added to affix the end of the sleeve at a point proximal to the distal end of the instrument and the second ring is located at the fold of the sleeve.
In accordance with another aspect of the invention, the sleeve further includes a pocket at the distal end of the sleeve to house the second and third rings.
In accordance with an additional aspect of the invention, the flexible tube may be coated with a lubricating material.
In accordance with yet another aspect of the invention, a method for using the protective sleeve in conjunction with a surgical instrument is provided wherein a protective sleeve is provided over a distal portion of the surgical instrument. The instrument is then inserted into a body lumen and placed in a desired location along the lumen. A distal end of the protective sleeve is then moved toward a proximal end of the sleeve to reveal the instrument.
In accordance with another aspect of the invention, a surgical procedure is then performed and the sleeve is moved back into position over the distal end of the surgical instrument. The instrument is then removed from the body lumen.
In accordance with another aspect of the invention, the protective sleeve is removed entirely from the instrument by tearing the sleeve along one or more perforations located along the length of the sleeve.
In accordance with yet another aspect of the invention, a fixed ring is used to hold the proximal end of the sleeve in place and the sleeve is removed by additionally tearing the sleeve along a circumferential perforation located at the same end of the sleeve as the fixed band.
Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
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patent: 60
Finnegan Henderson Farabow Garrett & Dunner L.L.P.
Leubecker John P.
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