Method of implanting ICD and subcutaneous lead

• US 7,076,294 B2
• Filed: 03/01/2004
• Issued: 07/11/2006
• 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): Pezzuto, Robert E.
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US10/790,903
• Publication Number:
  US 20040172071A1
• Time in Patent Office: 862 Days
• Field of Search: 607/2, 607 4- 5, 607/115, 607/116, 607/119, 607/122, 607/123
• US Class Current: 607/5
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• 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

Abstract

A subcutaneous implantable cardioverter-defibrillator which has an electrically active canister which houses a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potentially fatal heart rhythms delivers cardioversion defibrillation energy between at least one subcutaneous lead and the electrically active canister. There are no transvenous, intracardiac, or epicardial electrodes. The electrically active canister and at least one lead is implanted utilizing a curved introducer to implant the electrically active canister subcutaneously at various locations around the thorax.

Claims

1. A method of implanting a subcutaneous cardioverter-defibrillator in a patient, the method comprising:

providing a subcutaneously implantable cardioverter-defibrillator including an electrically active canister that serves as either an anode or a cathode of the cardioverter-defibrillator, wherein the canister houses a source of electrical energy, a capacitor, and operational circuitry, and the cardioverter-defibrillator further includes a subcutaneous lead connected to the canister, the lead including a subcutaneous cardioversion-defibrillation electrode that serves as the opposite electrode from the canister such that electrical cardioversion-defibrillation energy is delivered between the subcutaneous electrically active canister and the subcutaneous cardioversion-defibrillation electrode;

inserting the subcutaneous canister in a predetermined subcutaneous position within the thorax of the patient;

inserting the subcutaneous lead in a predetermined subcutaneous path extending around a portion of the thorax of the patient so that the cardioversion-defibrillation electrode is positioned such that electrical cardioversion-defibrillation energy is delivered to the heart of the patient when electrical cardioversion-defibrillation energy is delivered between the subcutaneous electrically active canister and the subcutaneous cardioversion-defibrillation electrode.

2. The method of claim 1, wherein inserting the subcutaneous lead includes using a curved introducer to make the subcutaneous path, and inserting the lead into the subcutaneous path.

3. The method of claim 1, wherein inserting the subcutaneous canister and inserting the subcutaneous lead includes:

making a skin incision in the thoracic region of the patient;

inserting a curved introducer through the skin incision to make a subcutaneous path in the thoracic region such that the a portion of the path is disposed at a location that if a straight line were drawn from the skin incision to the path termination the line would intersect the heart of the patient;

inserting the lead into the subcutaneous path such that the cardioversion-defibrillation electrode is disposed within the portion of the path;

placing the canister subcutaneously at the skin incision point; and

closing the skin incision.

4. A method of providing anti-arrhythmia therapy to a patient having a heart, the method comprising:

providing a subcutaneous implantable cardioverter-defibrillator including a subcutaneous electrically active canister that serves as either an anode or a cathode of the cardioverter-defibrillator, wherein the canister houses a source of electrical energy, a capacitor, and operational circuitry, the cardioverter-defibrillator further including a subcutaneous lead connected to the canister, the lead including a subcutaneous cardioversion-defibrillation electrode spaced from the canister that serves as the opposite electrode from the canister;

inserting the subcutaneous canister in a predetermined subcutaneous position within the thorax of the patient;

inserting the subcutaneous lead in a predetermined subcutaneous path extending around a portion of the thorax of the patient such that the cardioversion-defibrillation electrode is positioned at a subcutaneous location spaced from the canister; and

delivering electrical cardioversion-defibrillation energy to the heart of the patient between the subcutaneous electrically active canister and the subcutaneous cardioversion-defibrillation electrode.

5. The method of claim 4, wherein inserting the subcutaneous lead includes using a curved introducer to make the subcutaneous path, and inserting the lead into the subcutaneous path.

6. The method of claim 4, wherein inserting the subcutaneous canister and inserting the subcutaneous lead includes:

making a skin incision in the thoracic region of the patient;

inserting a curved introducer through the skin incision to make a subcutaneous path in the thoracic region such that the a portion of the path is disposed at a location that if a straight line were drawn from the skin incision to the path termination the line would intersect the heart of the patient;

inserting the lead into the subcutaneous path such that the cardioversion-defibrillation electrode is disposed within the portion of the path;

placing the canister subcutaneously at the skin incision point; and

closing the skin incision.