Elongated-member-driving apparatus – Surgical stapler – With magazine
Reexamination Certificate
2002-11-04
2004-10-19
Smith, Scott A. (Department: 3721)
Elongated-member-driving apparatus
Surgical stapler
With magazine
C227S019000, C227S178100, C227S176100
Reexamination Certificate
active
06805273
ABSTRACT:
The invention relates to a surgical stapling instrument, which can be used, e.g., in the diagnosis and therapy of all pathologies best treated by a curved stapled resection. It provides a means to extend the transluminal exploitation of mechanical suturing devices introduced via the anal canal, mouth, stomas, and service accesses. The treatment of rectal pathologies will be described as most frequent, but not only use of the invention.
The current transanal surgical procedure of choice is Transanal Endoscopic Microsurgery, which, however is burdened with difficulty of execution and complications such as dehiscence and abscesses. Current endoscopic excisions of, e.g., peduncular polyps usually do not allow necessary histological examination. This is of particular concern when the sample turns out to be malignant and the site is no longer visible during follow-up surgery. In the case of sessile polyps, the endoscopic excision presents similar drawbacks, and in addition difficulties in retrieving the sample, a related high loss of blood, and a risk of perforation of the intestinal wall. Traditional surgical excisions, for example via Transanal Endoscopic Microsurgery, are complicated and involve the intraluminal dissemination of neoplastic cells.
WO 97/47231 discloses an endoscopic stapler including a stapling head which is removably located on the distal end of an endoscope. The stapling head includes a stationary part, which houses a removable staple cartridge, and a movable part which includes an anvil for receiving and bending the ends of staples fired from the staple cartridge. The stationary part has a circular cross-sectional area, but the staples are arranged in two semi-circular rows, in which the staples are staggered relative to each other. The cross-sectional shape of the anvil is semi-circular, generally matching the rows of staples. After tissue to be excised has been clamped by moving the anvil towards the stationary part, the staples are consecutively expelled from the staple cartridge, and a knife cuts the tissue to be excised by moving along a staple line. Since the access for manipulating the tissue in order to place it correctly in between the anvil and the stationary part is somewhat obstructed by the cross-sectional shape of the stationary part, a remote-controlled forceps device is provided in the region of the staples and the anvil.
In U.S. Pat. No. 5,355,897, a surgical stapler is shown which derives from the well-known circular staplers for performing an anastomosis. In order to enable the local excision of tissue by means of this instrument, instead of a circular anastomosis, a shield extending around part of the periphery of the stapling region prevents unwanted tissue from entering the head of the device. A similar instrument is known from U.S. Pat. No. 5,360,154. In both cases, the region between the anvil and the staple cartridge is not easily accessible.
Surgical staplers comprising a staple cartridge having one or more straight rows of staples and a cutting blade running in parallel to the staples are disclosed in U.S. Pat. Nos. 4,665,916 and 4,881,545. In these instruments, tissue to be stapled and excised can be clamped between the staple cartridge and an anvil which is pivotally connected to the staple cartridge at one of its ends. Staplers having straight rows of staples, in which the staple cartridge can be moved in parallel relationship with respect to a stationary anvil in order to clamp the tissue to be stapled and excised, are known from U.S. Pat. Nos. 4,527,724, 5,137,198, and 5,605,272; these staplers are not provided with an automated cutting device. Generally, in many applications, straight staplers are not anatomically correct, i.e. straight staple lines do not fit a circular lumen contour.
U.S. Pat. No. 4,617,928 discloses a surgical instrument for Practising mechanical sutures and biopsies. This instrument comprises a fixed anvil and a staple cartridge (including a knife), which can be moved towards the anvil in order to clamp tissue between the anvil and the staple cartridge. In one embodiment, there are two staple rows arranged in a V-shaped configuration around a V-shaped knife. In another embodiment, an approximately semi-circular double row of staples surrounds an approximately semi-circular knife. In this embodiment, which is designed for practising pulmonary biopsies, free access to the inner faces of the cartridge and the anvil is hindered by an arm supporting the cartridge.
The object of the present invention is to provide an economical surgical stapling instrument for stapling (and optionally resecting) tissue, in particular inside the digestive track, which can be operated and used in a safe, effective, and fast manner.
This problem is solved by a surgical stapling instrument having the features of claim
1
. Advantageous versions of the invention follow from the dependent claims.
The surgical stapling instrument according to the invention comprises a frame having a body portion and a handle extending from the body portion in the proximal end region of the instrument. A staple fastening assembly is mounted in the distal end region of the instrument. Here and in the following, the terms “proximal” and “distal” relate to the user as reference, which means that the parts of the instrument close to the user under normal operating conditions are designated as “proximal”.
The staple fastening assembly includes a curved cartridge, which comprises at least one curved open row of staples, and, at the distal end of the instrument, a curved anvil, which is adapted to cooperate with the cartridge for forming the ends of the staples exiting from the cartridge. The staple forming plane of the anvil is arranged transversally with respect to the longitudinal axis of the body portion of the instrument. The staple fastening assembly is adapted to allow unobstructed access towards the concave inner faces of the cartridge and the anvil and thus to the tissue to be resected.
A cartridge moving device is adapted to move the cartridge essentially in parallel relationship towards the anvil from a spaced position for positioning tissue therebetween to a closed position for clamping the tissue. The staples can be driven out of the cartridge towards the anvil by means of a staple driving device.
Herein, the term “staple” is used in a very general sense. It includes metal staples or clips, but also surgical fasteners made of synthetic material and similar fasteners. Synthetic fasteners usually have a counterpart (retainer member) held at the anvil. In this sense, the terms “anvil” and “staple forming plane” also have a broad meaning which includes, in the case of two-part synthetic fasteners, the anvil-like tool and its plane where the retainer members are held, and similar devices.
Preferably, a knife is contained within the cartridge and is positioned such that there is at least one row of staples on at least one side of the knife. The knife is moved towards the anvil by means of a knife actuating device. If the stapling instrument does not include a knife, tissue to be resected after stapling can be cut by means of a separat surgical instrument.
The main advantage of the surgical stapling instrument according to the invention is its ability to allow endoluminal tissue resections and stapling through direct vision. Additionally, separate optics (e.g., an endoscope) can be used as an option. When the instrument is introduced into, e.g., the anal canal, free view onto and access to the site of the tissue to be resected is not obstructed by any parts of the instrument. The tissue to be excised can be pulled into the area in between the anvil and the cartridge, when the cartridge is in a spaced or open position, by means of a separate gripping instrument. Because of the unobstructed access towards the concave inner faces of the cartridge and the anvil, the gripping instrument can be used easily, effectively and safely. Afterwards, the cartridge is moved towards the anvil in order to clamp the tissue. A particular advantage is that the surgeon can we
Bilotti Federico
Longo Antonio
Chukwurah Nathaniel
Smith Scott A.
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