Unitary subcutaneous only implantable cardioverter-defibrillator and optional pacer

• US 8,135,459 B2
• Filed: 10/23/2007
• Issued: 03/13/2012
• Est. Priority Date: 09/18/2000
• Status: Expired due to Term

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Bardy, Gust H., Cappato, Riccardo
• Primary Examiner(s): Bertram, Eric D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US11/877,323
• Publication Number:
  US 20080046014A1
• Time in Patent Office: 1,603 Days
• Field of Search: 607 4- 5, 607/9, 607/119
• US Class Current: 607/4
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence

Abstract

A unitary subcutaneous implantable cardioverter-defibrillator 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 cardioversion-defibrillation 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.

Claims

1. A method of implanting a cardiac stimulus device into a patient comprising:

developing a space for receiving the cardiac stimulus device beneath the skin and over the ribcage of the patient; and

inserting a unitary cardiac stimulus device into the developed space;

wherein;

the unitary cardiac stimulus device comprises power supply, electronics, and electrodes such that, once implantation is complete, each of the power supply, electronics and electrodes are disposed within the developed space between the skin and the ribcage of the patient;

the unitary cardiac stimulus device comprises an elongated housing that has an elongated shape that conforms to the shape of one of the patient'"'"'s ribs once implanted;

the unitary cardiac stimulus device lacks any transvenous leads;

all of the electrodes of the unitary cardiac stimulus device are disposed on the housing, such that the implantation is completed without inserting any transvenous leads into the patient; and

the step of inserting the unitary cardiac stimulus device into the developed space does not include accessing the patient'"'"'s venous system.

2. The method of claim 1 wherein the developed space extends between the posterior axillary line and the anterior mid-clavicular line of the patient.

3. The method of claim 1 wherein the elongated housing has an elongated curve, the elongated curve of the housing sized to extend from an anterior region to a posterior region of the patient when implanted into the developed space.

4. The method of claim 1 wherein the unitary cardiac stimulus device comprises an outer housing that contains and protects the electronics, wherein the electrodes are disposed on the housing such that, once implanted in the developed space, at least a first electrode is disposed in a posterior region of the patient and a second electrode is disposed in an anterior region of the patient, with a portion of the patient'"'"'s heart disposed therebetween.

5. The method of claim 1 wherein the unitary cardiac stimulus device includes at least three electrodes placed at spaced locations thereon;

and the method further comprises programming the unitary cardiac stimulus device, once implanted, to use two best sensing electrodes in analyzing cardiac activity; and

adapting the selection of two best sensing electrodes to changes in patient physiology over time.

6. The method of claim 5 wherein the unitary cardiac stimulus device comprises a canister having the electrodes thereon, the canister further comprising physical switches disposed thereon, and the step of programming the unitary cardiac stimulus device is done via the switches on the canister.

7. The method of claim 5 wherein the step of programming the unitary cardiac stimulus device is performed using a programming wand.

8. The method of claim 5 wherein the step of programming the unitary cardiac stimulus device is performed via a wireless connection.

9. The method of claim 5 wherein the space for implanting extends between the anterior mid-clavicular line and the posterior axillary line;

and

the step of inserting the unitary cardiac stimulus device is performed such that a first electrode is disposed near an end of the unitary cardiac stimulus device in a posterior region of the patient;

second and third electrodes are disposed in an anterior region of the patient; and

a fourth electrode is disposed near an end of the unitary cardiac stimulus device in an anterior region of the patient.

10. The method of claim 9 wherein the first and fourth electrodes are coupled to internal circuitry within the unitary cardiac stimulus device as defibrillation electrodes, and the second and third electrodes are coupled to the internal circuitry as sensing electrodes.

11. The method of claim 9 wherein the first and fourth electrodes are coupled to internal circuitry within the subcutaneous cardiac stimulus device as sensing electrodes, and the second and third electrodes are coupled to the internal circuitry as defibrillation electrodes.

12. The method of claim 5 wherein the unitary cardiac stimulus device has an elongated shape and generally conforms to one of the patient'"'"'s ribs once implanted into the patient.