Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-12-30
2004-03-02
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S004010, C604S507000, C604S508000, C604S093010, C604S096010, C604S006140
Reexamination Certificate
active
06699231
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the localized delivery of therapy to specific tissue structures in a patient. More particularly, the present invention relates to methods and apparatus for delivering therapeutic and diagnostic agents and other forms of therapy to a tissue structure while the tissue structure is isolated from systemic circulation.
Systemic chemotherapy for the treatment of cancer and other diseases can be effective, but suffers from a number of undesirable side-effects. Many chemotherapeutic agents are cytotoxic with selectivity for rapidly dividing neoplastic (cancerous) cells. It is desirable to use relatively high dosages of these agents in order to approach or achieve complete eradication of the cancerous cells. Such high dosages, however, can have a very harsh impact on the patient, including bone marrow toxicity, hair loss, nausea, fever, inability to digest food, and even death.
To lessen such systemic toxicity, isolated perfusion of organs and limbs with chemotherapeutic agents has been proposed. For example, limbs have been isolated from circulation using an externally applied tourniquet while an artificial blood circulation is maintained within the limb as the chemotherapeutic agent is administered. In another example, the liver has been isolated on the systemic venous side using a balloon catheter while a chemotherapeutic agent is injected into the liver. In a third example, a very complex shunt system has been surgically implanted for isolating the liver and recirculating oxygenated blood carrying a chemotherapeutic agent, as described in U.S. Pat. No. 4,192,302. Known methods, however, have not enabled complete isolation of an organ to eliminate the risks of systemic toxicity, with the ability to maintain localized circulation through the organ as well as systemic circulation to the remainder of the organism, by means of devices positioned solely through endovascular or less-invasive surgical access. Therefore, such methods have not gained wide acceptance for chemotherapy or other diagnostic and therapeutic procedures.
It would therefore be desirable to provide improved methods, systems, apparatus, and kits for the localized delivery of therapeutic agents, diagnostic agents, and other forms of therapy to organs and other tissue structures for the treatment and diagnosis of cancers and other diseases. Preferably, such systems will provide complete or substantially complete isolation of the organ or tissue structure. Both isolation and perfusion will preferably be achieved without major surgical incisions, more preferably via minimally invasive access routes, and most preferably via an endovascular access route through a peripheral or other connecting blood vessel to arteries or veins associated with the tissue structure. Isolation of the tissue structure should permit both total recirculation of blood or other oxygenated carrier within the tissue to be treated and alternatively once-through perfusion of the tissue. In all cases, it will preferably be possible to achieve tissue perfusion in either an antegrade, retrograde, or combination antegrade/retrograde manner. The present invention will meet these and other objectives.
2. Description of the Background Art
A shunt system for circulating a chemotherapeutic agent through the liver in an open surgical procedure is described in U.S. Pat. No. 4,192,302. Catheters and systems for the localized delivery of chemotherapeutic and other therapeutic agents are described in U.S. Pat. Nos. 5,411,479; 5,209,717; 5,135,474; 5,069,662; 4,883,459; 4,867,742; 4,820,261; 4,714,460; 4,345,588; and PCT Application WO 94/22519. Intravascular and other drug delivery catheters are described in U.S. Pat. Nos. 5,599,307; 5,556,389; 5,505,700; 5,328,470; 5,167,628; 5,163,905; 5,087,244; 5,007,897; and 4,540,402. Intravascular bypass catheter systems are described in U.S. Pat. Nos. 5,478,309; 5,458,574; and 5,451,207. A catheter for hyperthermic treatment of a lung malignancy employing a perfluorocarbon medium is described in U.S. Pat. No. 5,158,536. Isolated organ and limb perfusion is discussed in Wang et al. (1996) Int. J. Radiation Oncology Biol. Phys. 34:309-311; Fajimura et al. (1995) Hepato-Gastroenterology 42:878-884; Matsuzaki et al. (1995) Ann. Thorac. Surg. 59:127-131; Pogrebniak et al. (1994) Ann. Thorac. Surg. 57:1477-1483; Turrisi 91993) Chest 103:565-595; Fried et al. (1993) J. Extra-Corpor. Tech. 25:22-26; Watanabe et al. (1990) Jpn. J. Surg. 20:27-35; Minchin et al. (1984) J. Pharmacol. Exp. Therap. 229:193-198; and Johnston et al. (1983) Cancer 52:404-409.
SUMMARY OF THE INVENTION
The present invention provides improved methods, systems, apparatus, and kits for the isolated perfusion of organs and other tissue structures. The systems, including multiple catheters as described in more detail below, can provide for partial or complete isolation of the vasculature of a tissue structure from the remainder of the patient's circulatory system. By providing such isolation, the vasculature within the tissue structure may be perfused with a desired therapeutic or diagnostic agent, with added or varied concentrations of oxygen, typically via recirculation of blood or other oxygen-carrying medium through the vasculature of the tissue structure with minimum or no loss of the agent into systemic circulation. Perfusion and/or recirculation may be achieved in an antegrade direction, a retrograde direction, or some combination of antegrade and retrograde directions. Additionally, various parameters within the isolated organ, such as temperature, pressure, chemical concentrations, and vascular permeability, may be adjusted for maximum local effect without systemic effect. Thus, the apparatus and methods of the invention enable the perfusion of organs and other tissue structures with therapeutic agents which are currently unavailable for systemic delivery due to their toxicity, as well as perfusion with currently-utilized therapeutic agents, but at such dosage levels, pressures, and temperatures or under such other conditions that systemic delivery would be harmful.
Methods according to the present invention preferably rely on first isolating the tissue structure from the patient's circulatory system and then delivering a therapeutic agent to the tissue structure. The tissue structure is isolated by endovascularly positioning a first catheter in an artery which supplies blood to the tissue structure and, preferably, deploying a first occluding member on or over the catheter to occlude the artery. A second catheter is endovascularly positioned in a vein to which blood drains from the tissue structure and deploying a second occluding member on or over the second catheter to occlude the vein. The therapeutic or diagnostic agent is then perfused through the vasculature of the tissue structure via at least one of the first and second catheters, while blood circulation continues through the remainder of the patient circulatory system and the vasculature of the tissue structure remains isolated from the circulatory system. In some cases it may not be necessary to occlude the artery supplying blood to the target organ, since the direction of blood flow into the organ will inhibit leakage of the therapeutic agent into the remainder of the arterial system. However, in most cases occlusion of both the arteries supplying blood to the organ and veins draining blood from the organ will be preferred so as to enable total isolation and perfusion of the organ without risk of systemic effects. As used herein, the term “isolating” may be used to mean complete isolation of an organ, by occluding all arteries supplying blood to the organ and all veins draining blood from the organ, or for partial isolation of the organ, wherein only some of such arteries and/or veins are occluded. Thus, the invention may be used to reduce normal circulation through the organ by, for example, as little as 30%-50%, preferably by 60%-80%, and most preferably by as much as 100%.
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Gifford, III Hanson S.
Putnam Joe B.
Siegel Lawrence C.
Sterman Wesley D.
Stevens John H.
Casler Brian L.
Heartport Inc.
Williams Catherine S.
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