Surgery – Internal organ support or sling
Reexamination Certificate
2002-05-15
2004-02-03
Lacyk, John P. (Department: 3736)
Surgery
Internal organ support or sling
C600S207000, C606S114000, C606S127000
Reexamination Certificate
active
06685628
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates in one embodiment to a method of performing an ovarian cystectomy by laparoscopy using a spill-proof endoscopic device. A spill-proof endoscopic device is also disclosed.
2. Description of the Related Art
Within the context of one embodiment of the present invention, ovarian cystectomy refers to the removal of a cyst from an ovary. Laparotomy refers to the traditional method of opening up the abdomen by making a large incision, typically about 12-14 cm in length. Oophorectomy is defined as the removal of the entire ovary. Laparoscopy is a method of performing intra-abdominal surgery via very small incisions, often 1 cm or less in length. Laparoscopic ovarian cystectomy is the removal of a cyst from the ovary using the technique of laparoscopy.
Ovarian cystectomy is a commonly performed procedure in gynecology. An attendant risk to this procedure, especially if done via laparoscopy, is the accidental leakage of the cyst content into the peritoneal cavity, which occurs most often during the separation of the cyst from the ovary. This can worsen the prognosis if the cyst turns out to be malignant or can lead to peritonitis if the cyst is a dermoid or mucinous cyst. Because of this hazard, ovarian cystectomy by laparoscopy requires more skill, time, and effort than that done via laparotomy if the cyst is to be removed without spillage. Consequently, many surgeons will opt to go directly to a laparotomy or perform a laparoscopic oophorectomy (which has a much lower risk of cyst leakage because the cyst is not separated from the ovary) instead of a laparoscopic cystectomy if he or she is uncertain about the nature of the cyst.
In addition, there is often no way to know in advance if the cyst is malignant, dermoid, mucinous, or otherwise. The physician must rely upon a combination of imprecise diagnostic indicators and guess work to determine whether or not a laparoscopic cystectomy can be safely attempted. This uncertainty and the fear of spillage cause many physicians not to attempt laparoscopic ovarian cystectomy or to feel very uncomfortable doing it.
Thus, a need exists for methods and apparatuses for performing a laparoscopic ovarian cystectomy safely and easily, without spilling the contents of the cyst into the peritoneal cavity. This will reduce the number of patients who suffer the harmful consequences of cyst spillage. This will also allow more laparoscopic ovarian cystectomies, instead of laparotomies or oophorectomies, to be performed.
The prior art discloses several types of endo-bags for use during a laparoscopic procedure. U.S. Pat. No. 5,215,521 to Cochran et al. discloses an entrapment envelope which is inserted through a laparoscopic port for removal of a surgically severed organ.
U.S. Pat. No. 6,059,793 to Pagedas discloses a reusable bag for retrieval of a mass, such as an excised organ, through a laparoscopic sleeve and also allows for morsellizing the severed organ.
U.S. Pat. No. 6,270,505 to Yoshida et al. discloses an inflatable endo-bag for organ removal, ports for surgical instruments and a closing string.
All of the prior art references discussed above are drawn to encapsulation of an organ after it has been surgically severed from its attachments to the body. In particular, all of these prior art references address the problem of transport of an organ outside the abdominal cavity after it has been laparoscopically excised inside the abdominal cavity. Accordingly, these prior art references do not address the special problem of separating a mass, such as a cyst, from a live, intact organ such as an ovary without rupture of the cyst and spillage of its contents.
U.S. Pat. No. 5,279,539 to Bohan et al. discloses a bioabsorbable surgical pouch which can be placed over an ovary after a surgical procedure to prevent surgical adhesions. However, Bohan et al. do not disclose the use of the pouch during a surgical procedure such as performing an ovarian cystectomy.
There are typically two steps involved in the removal of an ovarian cyst by laparoscopy. The first step is the separation of the cyst from the ovary. The second step is the transport of the cyst outside of the abdominal cavity once it has been separated from the ovary. There are problems associated with each step. The problem in the first step is how to separate the cyst from the ovary without rupturing the cyst and spilling its contents. The problem with the second step is how to transport a large cyst outside the abdominal cavity through a small opening in the abdomen. All of the prior art discussed above are involved only with the problem associated with the second step, that is, transport of a mass or organ outside the abdomen after it has been excised.
SUMMARY OF THE INVENTION
Preferred embodiments of the present invention address the first problem, specifically, separation of a mass such as a cyst from an ovary without spilling its contents into the abdominal cavity. It will be appreciated, however, that the methods and apparatuses discussed herein are not limited to ovarian cystectomies, and therefore, may have applicability to any procedure wherein it is desired to remove biological or other material from an organ, or to remove an organ itself, in a contained environment.
Several unique features are disclosed by the preferred embodiments discussed below. First, in one embodiment, an intact organ is encapsulated, preferably with a non-permeable bag-type structure, while it is still attached to the body. As used herein, an intact organ is defined as an organ that is still attached to the body as found in its natural state. The intact organ is preferably a live intact organ. However, intact organs which contain dead tissue are also encompassed within the present invention. The encapsulation of an intact organ is in contrast to the prior art references discussed above, wherein encapsulation can only occur after the organ or mass has been completely separated from its attachment to the body. Thus, in the prior art discussed above, the organ or mass is first completely excised and then encapsulated. In preferred embodiments of the present invention, the organ or mass is first encapsulated and then the process of excision is performed. These embodiments advantageously allow a mass, such as an ovarian cyst, for example, to be separated from the ovary without spilling its contents into the abdominal cavity.
In one embodiment, the disclosed bag surrounding the intact organ is provide with multiple openings for insertion of one or more instruments. These instruments may be inserted simultaneously to perform operations on an intact organ such as removal of a cyst from an ovary, or other desired procedures. In one embodiment, openings are provided with a one-way valve.
In one embodiment, the bag is a balloon-like structure designed to prevent spillage of the cyst content into the peritoneal cavity and thus make laparoscopic ovarian cystectomy safe and easy. The balloon-like structure preferably comprises an inflatable, water-tight, fire-retardant bag with an opening on a distal side thereof and a gas nozzle on a proximal side hereof. In a preferred embodiment, the bag is funnel-shaped and has a large noose-like opening at the distal end. In one embodiment, the proximal end is long and tapered. In a preferred embodiment, the distal end has a relatively large opening, at least large enough to encapsulate an ovary or other organ.
The bag in one embodiment used for laparoscopic ovarian cystectomy is introduced into the peritoneal cavity through a laparoscopic port, the proximal end with the gas nozzle being retained on the outside of the body for gas infusion. Once inside the peritoneal cavity, the large distal opening of the bag is then placed over the ovary and fastened. In a preferred embodiment, a noose is tightened down over the ovarian pedicle and locked in using a fastening device such as a trumpet valve. As used herein, the term “pedicle” is used in its ordinary sense and refers to any stem-like structure that extends from an or
Knobbe Martens Olson & Bear LLP
Lacyk John P.
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