Elongated-member-driving apparatus – Surgical stapler – With magazine
Reexamination Certificate
2000-08-04
2001-10-16
Smith, Scott A. (Department: 3721)
Elongated-member-driving apparatus
Surgical stapler
With magazine
C227S019000, C227S178100, C227S180100
Reexamination Certificate
active
06302311
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a surgical stapler for applying surgical staples to tissue. More particularly, the present invention relates to a surgical stapler which is attached to an endoscope. The present invention has particular application to transanal or transoral surgical procedures, although it is not limited thereto.
2. State of the Art
It has been long known in the surgical arts that surgical staplers provide an expeditious and efficient way of joining or repairing tissue. In fact, in certain types of surgical procedures, the use of surgical staples has become the preferred method of joining tissue as opposed to suturing. A common use of surgical staplers relates to the repair of the colon after a portion of the colon has been removed. For example, when a tumor is found in the colon, it is not uncommon to remove a large portion of the colon. The remaining sections of the colon are then joined together in a surgical procedure called anastomosis, where the tubular sections are joined together to form a continuous tubular pathway.
In the anastomosis procedure, the abdominal cavity of the patient is typically opened to expose the diseased portion of the colon. The diseased portions of the colon are then surgically removed, and the remaining portions of the colon are joined together. Prior to the use of staplers, the anastomosis procedure was laborious and lengthy as the surgeon had to cut and precisely align the ends of the intestine and maintain the alignment while joining the ends with sutures. The development of circular staplers greatly simplified the anastomosis procedure by permitting the surgeon to simultaneously provide one or more rows of staples which join sections of the colon while cutting away excess tissue which would otherwise occlude the tubular passageway. However, even with the use of the circular stapler, it is still necessary to create an access port in an otherwise healthy portion of the colon for entry and removal of the stapler. After the stapler is used for anastomosis, and then removed from the colon through the access port, it is necessary to repair the colon at the access port via suturing or linear stapling.
Many different circular staplers are known in the art, and several are commercially available. For example, circular staplers are sold under the PROXIMATE brand by Ethicon Inc., Somerville, N.J. such as are described in U.S. Pat. No. 5,205,459 to Brinkerhoff et al., U.S. Pat. No. 5,261,920 to Main et al., U.S. Pat. No. 5,271,544 to Fox et al., U.S. Pat. No. 5,285,945 to Brinkerhoff et al., U.S. Pat. No. 5,333,773 to Main et al, and U.S. Pat. No. 5,445,644 to Pietrafitta et al., all of which are hereby incorporated by reference herein in their entireties. Other circular staplers are sold under the AUTO SUTURE brand by United States Surgical Corporation, Norwalk, Conn. and are described in U.S. Pat. No. 4,576,167 to Noiles, U.S. Pat. No. 5,005,749 to Aranhi, U.S. Pat. No. 5,193,731 to Aranyi, No. U.S. Pat. No. 5,360,154 to Green, U.S. Pat. No. 5,443,198 to Viola et al., U.S. Pat. No. 5,437,684 to Calabrese et al., U.S. Pat. No. 5,447,514 to Gerry et al., U.S. Pat. No. 5,454,825 to Van Leeuwen et al., and U.S. Pat. No. 5,474,223 to Viola et al., all of which are also hereby incorporated by reference herein in their entireties. Generally common to all circular staplers are several elements, including a staple head assembly, a shaft assembly, and a handle assembly. The staple head assemblies all include a staple holder which holds a plurality of staples arranged around a circular periphery, a circular anvil which acts to form the ends of staples driven through the tissue, a circular knife or scalpel, and a driver which drives the staples from the staple holder and actuates the knife. The shaft assembly typically includes a substantially rigid longitudinally curved shaft which holds a tension member for transmitting tension from an actuator handle to the anvil to resist forces on the anvil, a compression member for transmitting a compressive force from the actuator handle assembly for advancing the staple driver to drive the staples into the tissue and to drive the knife through the tissue adjacent the staples. The handle assembly typically includes a handle, and one or more levers and/or knobs. The levers and knobs are used for moving the anvil relative to the staple holder, and for firing the staples and the knife.
While great improvements in circular staplers have been made over the years, it will be appreciated by those skilled in the art that the anastomosis procedure is still an extremely invasive procedure which leaves both external and internal scars. Indeed, not only must the abdominal cavity be opened, but a large segment of the colon is typically removed to avoid the possibility of recurrence, as recurrence would lead to another traumatic surgery. Moreover, as described above, the colon must be punctured at a healthy location to provide a port for the circular stapler, and this puncture must then be sutured or stapled (as must the abdominal cavity).
Clearly, it is desirable to avoid excessive trauma to healthy portions of the colon during the anastomosis procedure. Toward that end, various flexible surgical staplers have been proposed which theoretically can be introduced transanally such that the colon need not be punctured at a healthy location to provide an access port for the stapler. These flexible shaft staplers are disclosed inter alia in U.S. Pat. No. 4,671,445 to Barker et al., U.S. Pat. No. 4,473,077 to Noiles et al., U.S. Pat. No. 4,488,523 to Shichman, U.S. Pat. No. 4,754,909 to Barker et al., U.S. Pat. No. 5,258,008 to Wilk, U.S. Pat. No. 5,271,543 to Grant et al., and U.S. Pat. No. 5,433,721 to Hooven et al., and PCT application WO 93/15668 to Blanco et al., all of which are incorporated by reference herein in their entireties. While these flexible shaft staplers provide one advantage, they do not obviate the need for abdominal surgery, as when the stapler is in place, there is no manner of viewing the surgical site other than via laparoscopic or open abdominal surgery. In addition, the flexible shaft staplers suffer from other shortcomings. In particular, some of the flexible shaft staplers do not have long shafts which would permit them to reach well up into the colon. Others of the flexible shaft staplers have shaft assemblies which are cumbersome and/or impractical and expensive to build. Others of the flexible shaft staplers have stiffening problems due to the force required for the simultaneous firing of multiple staples which are circumferentially disposed. Regardless of the particular nature of the shortcomings, they have apparently been such that the flexible shaft staplers have not been commercially successful.
In a similar vein to the flexible surgical staplers is U.S. Pat. No. #5,197,649 to Bessler et al. which is hereby incorporated by reference herein in its entirety, and which provides a steerable endoscopic stapler which is introduced via the rectum, but which requires that the diseased portion of the colon be already removed using invasive surgical tools. The steerable endoscopic stapler of Bessler et al. proposes a custom instrument which includes the basic steering and ocular capabilities of a standard endoscope, a circular staple head assembly at the distal end of the endoscope, and a cable and pulley system for bringing the anvil and stapler of the staple head together and firing the staples and knife. While the concept of combining the visual apparatus of the endoscope with the stapler in a single device has certain advantages, it will be appreciated by those skilled in the art that an entire re-engineering of the commonly used endoscopes is undesirable. Indeed, staplers are typically disposable instruments because of difficulties in cleaning and controlling critical dimensions, while endoscopes are very expensive reusable instruments. A combination instrument as proposed by Bessler et al. would therefore be economically unfeasi
Adams Ronald David
Gordon David P.
Main Lauren O.
Pugsley, Jr. Charles H.
Swaffar Scott E.
Boston Scientific Corporation
Kenyon & Kenyon
Smith Scott A.
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