Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
1999-11-12
2002-05-07
Dawson, Glenn K. (Department: 3764)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C606S001000, C600S201000
Reexamination Certificate
active
06383162
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to surgical appliances and methods, and more particularly to an improved apparatus and method for perfusion and lavage of an abdomino-pelvic area both during and after surgery; and in particular when using cell-cycle specific chemotherapy drugs which require long-term contact with tissues in order to achieve their optimal effect. By allowing prolonged and repeated access to an abdominal cavity the apparatus can assist in the management of serious intra-abdominal infections. Additionally, by permitting repeated access to the abdominal cavity, the apparatus is adapted for non-oncologic use in the treatment of intra-abdominal sepsis, peritonitis and pancreatitis.
BACKGROUND OF THE INVENTION
One of the mechanisms of the dissemination of gastrointestinal and gynecologic cancers is the intraperitoneal dissemination of the disease. Without special treatments all patients with peritoneal dissemination of cancer die; most patients die within one year. In an attempt to improve the control of intra-abdominal cancer, large doses of anti-cancer drugs can be injected directly into the peritoneal cavity. This therapy has shown beneficial effects in selected patients. Also other therapies in addition to intraperitoneal chemotherapy have been developed in an effort to better control the peritoneal dissemination of cancer.
It has been observed that hyperthermia seems to have a direct anti-cancer effect and synergy with some types of anti-cancer drugs, so that the toxicity for cancer cells is significantly increased at an elevated temperature. Examples of chemotherapy drugs which have been found effective in hyperthermic perfusion of the peritoneal cavity are cisplatin (CDDP) and mitomycin C (MMC). Accordingly, hyperthermic peritoneal lavage with a chemotherapy solution has been utilized to wash away free cancer cells in the peritoneal cavity by irrigation with a large volume of perfusate, to kill cancer cells by hyperthermia, and to kill cancer cells by the direct effects of chemotherapy. However, due to the inherent long and short term toxicity of chemotherapy solutions to operating room personnel, lavage with a chemotherapy solution can only be safely performed in a contained environment that prevents splashing, spillage and aerosol contaminants from escaping into the local atmosphere creating an environmental hazard to health care personnel.
Conventional techniques employing hyperthermic peritoneal lavage rely upon the use of a tube for infusion of heated fluid into the peritoneal cavity, and one or more drain tubes for removing the perfusate from the cavity. The lavage fluid can contain acid to lower pH, sugar to elevate glucose levels, antibiotics, chemotherapy (using single or multiple agents) and fibrinolytic agents, and can be exchanged to irrigate away cancer cells, fibrinous debris and other intra-abdominal contaminants. The tubes can be inserted through small stab incisions formed in a wall of the abdomen and guided by the surgeon into a general anatomic site in which irrigation is desired, or the surgeon can make a larger incision and visually place the tubes for appropriate irrigation of the peritoneal cavity.
Direct manipulation of the tubes and of the patient's viscera during chemotherapy perfusion of the abdomino-pelvic cavity in order to guarantee uniform distribution is impossible with the conventional stab-incision technique due to the lack of access to the patient's abdomino-pelvic cavity which is afforded to the surgeon. Although direct manipulation of the tubes and viscera may be accomplished in circumstances where large incisions are employed, the inability of these conventional open abdomen techniques to contain and prevent spillage of inherently toxic lavage fluid and its aerosols thus presents a significant risk of contamination of the surgical environment with a resultant unacceptable risk of exposure of health care personnel to toxic substances.
Heated intraperitoneal chemotherapy is used to bring as much dose intensity to the affected abdominal and pelvic surfaces as is possible. Heat by itself has been shown to have a greater toxicity for cancerous cells than for normal tissues. Heat also increases the penetration of chemotherapy into tissues. As the tissues soften in response to the heat the elevated interstitial pressure of a tumor mass may decrease thereby allowing improved drug penetration. Furthermore, heat increases the cytotoxicity of selected chemotherapy agents. This synergism occurs only at the interface of heat and body tissue, at the peritoneal surface. However, in conventional techniques the temperature of the lavage fluid is typically monitored on the inflow and outflow tubes but not throughout the peritoneal cavity, thereby reducing the accuracy of control over temperature and thus possibly increasing the danger of heat injury and reducing the effectiveness of the hyperthermic treatment.
The effectiveness of hyperthermic abdomino-pelvic perfusion using conventional techniques is further reduced because the heated chemotherapy solutions may not reach cancer cells between adherent surfaces in the deep areas of the peritoneum or mesenterium, and thus the perfusate incompletely eradicates cancer cells within the peritoneal cavity.
Moreover, assessment of the efficacy of treatments for peritoneal surface cancer by measuring the ascites volume or imaging a layer of cancer by computer tomography or ultra-sonography or the cytologic examination of ascites is remarkably ineffective in revealing residual or recurrent cancer in the peritoneal cavity.
Additionally, the inability to contain the environment within which conventional abdomino-pelvic perfusion is performed for an extended period of time further reduces its effectiveness because it limits or precludes the ability to use cell-cycle specific drugs such as 5-fluorouracil, which achieve their optimal effect through continuous long-term exposure of 5-10 days.
There are limited diagnostic methods available to establish the occurrence of peritoneal dissemination of cancer. In most patients, this pattern of dissemination is seen at the time of surgical removal of the primary gastrointestinal or ovarian cancer. In a small proportion of patients, the peritoneal recurrence of cancer can be imaged by abdominal computerized tomography. In other patients, the rise in a tumor marker can lead to the diagnosis of peritoneal dissemination. In some situations, a second look operation (SLO) is the only reliable procedure to assess the disease state of the cancer patient.
The SLO was introduced into gastrointestinal and gynecologic surgery to provide an oncologist with a means for assessing the status of the disease approximately one year after the initial operation, before advanced disease has occurred and before the reactivation of symptoms. In gynecology, especially, SLO has been gradually approved as a useful means for assessing tumor response, removing recurrent cancer, and planning subsequent treatment in the follow-up of patients with ovarian cancer.
In order to overcome at least some of the shortcomings of prior techniques, while at the same time taking advantage of the beneficial effect of intraperitoneal chemotherapy and hyperthermia in cancer therapies, a method and apparatus for continuous hyperthermic peritoneal perfusion in combination with the administration of anti-cancer drugs having synergism with hyperthermia was developed, and disclosed, in Takashi Fujimura, et al., “
Continuous Hyperthermic Peritoneal Perfusion for the Treatment of Peritoneal Dissemination in Gastric Cancers and Subsequent Second-Look Operation”, Cancer
65:65-71, 1990. Other similar methods and apparatuses are disclosed in Sugarbaker, U. S. Pat. No. 5,336,171, the contents of which is specifically incorporated herein in its entirety by reference, and Sugarbaker, “
Management of Peritoneal Surface Malignancy using Intraperitoneal Chemotherapy and Cytoreductive Surgery
”, The Ludann Company, November 1998, the entire contents of which is also incorporated herein by reference. Ne
Berkowitz Marvin C.
Dawson Glenn K.
Maynard Jennifer
Nath Gary M.
Nath & Associates PLLC
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