Elongated-member-driving apparatus – Surgical stapler – With magazine
Reexamination Certificate
1997-12-10
2001-07-24
Dawson, Glenn (Department: 3761)
Elongated-member-driving apparatus
Surgical stapler
With magazine
C227S175100, C606S167000, C606S219000
Reexamination Certificate
active
06264086
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to surgical apparatus and procedures and specifically to surgical apparatus and procedures for resectioning, preferably endolumenally, diseased or otherwise undesirable portions of lumenal or other tissue and anastomizing remaining, healthy lumenal or other tissue.
LEXICON
This invention relates to surgical apparatus and procedures and accordingly, utilizes terminology from the medical and mechanical engineering fields. To facilitate understanding of this invention by workers in both fields, the following lexicon is provided; it is to be understood that plurals and close variants of these words also have the meanings indicated:
Anastomose: To connect or join by anastomosis; to communicate by anastomosis.
Anastomosis: The union of parts or branches (such as streams, blood vessels, or leaf veins) so as to intercommunicate; a product of anastomosizing, such as a network.
Anastomize: To cut in pieces in order to display or examine the structure and use of the parts; to dissect.
Appendicolith: A stone within the appendix.
Cannulation: Insertion within a lumen.
Endoscopy: Visual inspection of any cavity of the body by means of an endoscope.
Endolumenally: Pertaining to the intralumenal aspect of a hollow organ.
Enterotomy: Cutting completely through the bowel wall irrespective of the direction of cutting.
Laparotomy: surgical incision through the flank to gain access to the peritoneal cavity.
Lesion: Any pathological or traumatic discontinuity of tissue or loss of function of a body part.
Ligate: To tie or bani with a ligature in order to crush or strangulate.
Lumen: The cavity of a hollow organ.
Morbid: Of, relating to or characteristic of disease.
Mural: Pertaining or occurring in the wall of a cavity.
Polypectomy: Surgical removal of a polyp.
Resection: Surgical removal of part of an organ or structure.
Serosal: Pertaining to or composed of any serous membrane.
Sessile: Attached by a base; not pedunculated or stalked.
Staple: Tissue ligature or suture.
Submucosal: Pertaining to the submucosa; situated beneath the mucous membrane.
Transect: A section made across a long axis; a crosssection; division by cutting transversely.
Transmural: Through the wall of an organ, extending through or affecting the entire thickness of the wall of an organ or cavity.
DESCRIPTION OF THE PRIOR ART
Endoscopy studies the intra-lumenal aspects of hollow organs of the upper and lower intestine including the esophagus, stomach and the colon through cannulation of the lumen via the mouth or anus.
Endoscopic polypectomy is presently limited to a submucosal resection. The endoscopist is often unable to completely resect a sessile polyp or lesion and therefore the patient is subjected to subsequent definitive surgery, i.e. resection of the base of the tumor. Endoscopic polypectomy can be used to debunk sessile masses but it is unable to resect mural disease. Incomplete resection of a sessile polyp may destroy the biopsy specimen and alter the relationship of the gross specimen given to the pathologist thereby resulting in the pathologist possibly providing incorrect or incomplete study results. The endoscopist is also unable to correct uncommon but life threatening procedural complications such as perforations.
Surgical approaches for resectioning diseased tissue are largely practiced by making large laparotomy incisions or using minimally invasive techniques such as laparoscopic surgery in which tissues are resected and repaired through small incisions.
There are numerous surgical devices enabling surgeons to resect diseased tissue and subsequently anastomosize remaining tissue either through a conventional incision or using a laparoscope and making one or more relatively small incisions. Additionally, endoscopically assisted stapling devices are known which enable surgeons to remotely anastomose lumenal structures such as the bowel. Endoscopically assisted bowel anastomosis nevertheless typically requires extra-lumenal assistance via a traditional laparotomy incision or use of a laparoscope.
Trends in surgery are towards minimally invasive procedures as evidenced by developments including laparoscopic cholecystectomy, laparoscopic appendectomy and laparoscopically assisted partial colectomies and hernia repairs. All of these minimally invasive procedures involve introducing a laparoscope through the abdominal wall and creating other associated openings to gain access to the peritoneal cavity in order to perform the necessary surgical procedure. Typically, general anesthesia is required. Endoscopically possible procedures include polypectomy, mucosectomy, and cauterization.
Disadvantages of the laparoscopic method include the need to traverse the abdominal wall, increased operating time secondary to the lack of exposure for the procedure and possibly the need to convert to an “open” laparotomy in the course of performing the procedure.
Present stapling techniques in surgery are for the most part functionally adequate but limited. Devices exist including the GIA and EEA staplers which can be used to transect tissue in a linear and circular fashions respectively with subsequent anastomosis with staples. The linear GIA is relatively versatile. The EEA is primarily suited for lower colonic circular anastomosis after a lesion has been surgically removed (via laparotomy or laparoscopically) or during a colostomy take-down procedure.
The rigid post of the EEA stapler severely limits its use as well as requiring that an open procedure be utilized. The steerable endoscopic stapler is useful in allowing for more bowel accessibility; however, it remains dependent upon trans-abdominal surgical exposure prior to utilization.
While laparoscopic surgical instruments have been used for bowel anastomosis, in such procedures the bowel is anastomosized extracorporially or in an augmented stapled side-to-side fashion.
Possibly relevant to the patentability of this invention are U.S. Pat. Nos. 5,156,614; 5,170,925; 5,172,845; 5,180,092; 5,188,274; 5,188,638; 5,197,648; 5,197,649; 5,217,472; 5,219,111; 5,220,928; 5,221,036; and 5,242,457.
Non-patent prior art possibly relevant to the patentability of this invention includes the article “An Endoscopic Stapling Device: The Development of a New Flexible Endoscopically Controlled Device for Placing Multiple Transmural Staples in Gastrointestinal Tissue” appearing at pages 338 and 339 of Gastrointestinal Endoscopy, vol. 35, no. 4, published in 1989, and the article “An Endoscopic Sewing Machine” appearing at pages 36 through 38 of Gastrointestinal Endoscopy, vol. 32, no. 1, published in 1986.
OBJECTS OF THE INVENTION
An object of this invention is to provide methods and apparatus for performing transmural surgical procedures endolumenally without requiring incisions in the skin.
It is another object of this invention to provide methods and apparatus for endolumenal surgery resulting in decreased morbidity and mortality relating to or resulting from general anesthesia and further providing decreased post-operative recovery time secondarily to the lack of a body surface incision.
It is another object of this invention to provide methods and apparatus for improved treatment of lesions such as bowel tumors, providing the opportunity to diagnose, resect and cure patients without the need for subsequent open laparotomy or laparoscopic surgery.
It is another object of this invention to provide apparatus for endolumenal surgery where the apparatus is a coaxial unitary assembly.
It is another object of this invention to provide such apparatus which is flexible in order to reach any portion of the bowel or any other lumen into which the apparatus is inserted.
SUMMARY OF THE INVENTION
This invention facilitates preferably endoscopically or radiologically assisted, preferably visually guided endolumenal surgery to resect diseased tissue in a full transmural fashion. Once the resection has occurred, the invention facilitates anastomization of clean margins in either an end-to-end anastomosis or a simple enterotomy closure. The invention is not limite
Dawson Glenn
Kenyon & Kenyon
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