(12) United States Patent ao) Patent No.: us 6,280,414 Bi
Shah et al. (45) Date of Patent: Aug. 28,2001
(54) METHOD AND APPARATUS FOR LOCAL DELIVERY OF THERAPEUTIC AGENT
(75) Inventors: Chirag B. Shah, Nashua, NH (US);
Richard A. Gambale, Tynsboro;
Stephen J. Forcucci, Arlington, both ol
(73) Assignee: Medtronic AVE, Inc., Santa Rosa, CA (US)
( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.
(21) Appl. No.: 09/164,171
(22) Filed: Sep. 30, 1998
(51) Int. C I. A61M 29/00
(52) U.S. CI 604/104; 604/107
(58) Field of Search 604/96, 101, 104-109,
604/264, 508, 509, 523; 606/192, 194,
(56) References Cited
U.S. PATENT DOCUMENTS
5,161,534 * 11/1992 Berthiaume .
5,554,119 9/1996 Harrison et al. .
5,713,860 * 2/1998 Kaplan et al 604/96
5,713,863 * 2/1998 Vigil et al 604/104
5,752,518 5/1998 McGee et al. .
5,772,590 6/1998 Webster, Jr. .
FOREIGN PATENT DOCUMENTS
0 841 040 Al 5/1998 (EP) .
Steven R. Bailey, Mechanisms of Delivery and Local Drug Delivery Technologies, Semin Intervent Cardiol 1996, pp. 17-23.
* cited by examiner
Primary Examiner—Sharon Kennedy
(74) Attorney, Agent, or Firm—Sterne, Kessler, Goldstein
& Fox P.L.L.C.
The present invention provides a device and method for delivering a therapeutic substance to a treatment site within a patient such as a vessel that has undergone angioplasty. The device provides flexible conduits placed together in the vessel along with a shaft that is attached to their distal ends. After being navigated to the treatment site, the shaft may be moved relative to the conduits causing them to buckle and bow radially outward into contact with the tissue to be treated. The therapeutic substance is then pressurized to be delivered through perfusion ports along the distal portion of the conduits. Because the conduits can be expanded into contact with the treatment site without the assistance of an inflatable member, blood flow through the region during delivery of the therapeutic substance is not interrupted in any significant way. Alternatively, the present invention may be used in conjunction with a balloon angioplasty catheter to deliver therapeutic substances after the dilatation procedure. As with the first embodiment, the delivery conduits may be expanded independently from the dilatation balloon so that blood flow will not be interrupted during delivery of the therapeutic substance.
33 Claims, 6 Drawing Sheets