Unitary subcutaneous only implantable cardioverter-defibrillator and ...

(54) UNITARY SUBCUTANEOUS ONLY IMPLANTABLE CARDIOVERTERDEFIBRILLATOR AND OPTIONAL PACER

(75) Inventors: Gust H. Bardy, Seatlle, WA (US);

Riccardo Cappato, Ferrara (IT)

(73) Assignee: Cameron Health, SanClemente, CA (US)

( * ) Notice: Subject to any disclaimer, the term ol this patent is extended or adjusted under 35 U.S.C. 154(b) by 282 days.

(21) Appl. No.: 09/663,606

(22) Filed: Sep. 18, 2000

(51) Int. C I. A61N 1/39

(52) U.S. CI 607/5; 607/4; 607/36;

607/119

(58) Field of Search 607/4, 5, 9, 36,

607/119

(56) References Cited

U.S. PATENT DOCUMENTS

6,144,879 A * 11/2000 Gray 607/20

6,266,567 Bl * 7/2001 Ishikawa et al 607/36

6,280,462 Bl * 8/2001 Hauser et al 607/5

FOREIGN PATENT DOCUMENTS

EP 0 517 494 A3 12/1992

EP 0 517 494 A2 12/1992

EP 0 517 494 Bl 12/1992

EP 0 627 237 Al 12/1994

WO WO 97/29802 A3 8/1997

WO WO 97/29802 A2 8/1997

WO WO 99/53991 Al 10/1999

OTHER PUBLICATIONS

International Search Report dated Mar. 26, 2002, PCT/ US01/29168 filed Sep. 14, 2001, published as WO 02/22208 on Mar. 21, 2002, Subcutaneous Only Implantable Cardioverter Defibrlillator & Optional Pacer, Inventors: Gust H Bardy et al.

(List continued on next page.)

Primary Examiner—-Jeffrey R. Jastrzab

(74) Attorney, Agent, or Firm—Gottlieb, Rackman &

Reisman, PC.

(57) ABSTRACT

A unitary subcutaneous implantable cardioverterdefibrillator is disclosed which has a long thin housing in the shape of a patient's rib. The housing contains a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potentially fatal heart rhythms. Provided on the housing are cardioversion/defibrillation electrodes located to deliver electrical cardioversiondefibrillation energy when the operational circuitry senses a potentially fatal heart rhythm. The unitary subcutaneous implantable cardioverter-defibrillator does not have a transvenous, intracardiac, epicardial, or subcutaneous electrode.

104 Claims, 3 Drawing Sheets

OTHER PUBLICATIONS

Written Opinion dated Sep. 10, 2002, PCT/US01/29168 filed Sep. 14, 2001, published as WO 02/22208 on Mar. 21, 2002, Subcutaneous Only Implantable Cardioverter Defibrlillator & Optional Pacer, Inventors: Gust H Bardy et al. International Search Report dated Mar. 21, 2002,, PCT/ US01/29106 filed Sep. 14,2001, published as WO 02/24275 on Mar. 28, 2002, Unitary Subcutaneous Only Implantable Cardioverter Defibrillator & Optional Pacer, Inventors: Gust H Bardy et al.

Written Opinion dated Sep. 3, 2002, PCT/US01/29106 filed Sep. 14, 2001, published as WO 02/24275 on Mar. 28, 2002, Unitary Subcutaneous Only Implantable Cardioverter Defibrillator & Optional Pacer, Inventors: Gust H Bardy et al.

Journal of the American Medical Association (JAMA), Vol 214, No 6, 1123pp, Nov. 9, 1970, "Completely Implanted Defibrillator", an editorial comment by JC Schuder PhD. Amer Soc Trans Artif Int Organs, Vol XVI, 1970, 207-212pp, "Experimental Ventricular Defibrillation With An Automatic & Completely Implanted System", by JC Schuder PhD et al.

Archives of Internal Medicine (Specialized Journal of the AMA), Vol 127, Feb. 1971, Letters to the Editor 317pp, "Standby Implanted Defibrillators", an editirial comment by JC Schuder PhD.

Journal of the American Medical Association (JAMA), Vol 213, 615-616pp, 1970, "Automatic Detection & Defibrillation of Lethal Arrhythmias—A New Concept", by Mirkowski et al.

IEEE Transactions on Bio-Medical Engineering, Vol BME-18, No 6, Nov. 1971, 410-415pp, "Transthoracic Ventricular Defibrillation In The Dog With Truncated and Untruncated Exponential Stimuli", by JC Schuder PhD et al.

Pace, Vol 16, Part I, Jan. 1993, 95-124pp, "The Role Of An Engineering Oriented Medical Research Group In Developing Improved Methods & Devices For Achieving Ventricular Defibrillation: The University Of Missouri Experience", by JC Schuder PhD.

Journal of Cardiovascular Electrophysiology, Vol 12, No 3, Mar. 2001, 356-360pp, Copyright 2001, by Future Publishing Company Inc, Armonk-NY 1050-0418, "Nonthoracotomy Implantable Cardioverter Defibrillator Placement In Children", by Rainer Gradaus MD et al.

Journal of Cardiovascular Electrophysiology, Vol 12, No 3, Mar. 2001, 361-362pp, Copyright 2001, by Future Publishing Company Inc, Armonk-NY 1050-0418, "Implantable Defibrillators In Children: From Whence to Shock", by Richard A Friedman MD et al.

* cited by examiner