Subcutaneous cardioverter-defibrillator

• US 20060247688A1
• Filed: 04/28/2005
• Published: 11/02/2006
• Est. Priority Date: 04/28/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Olson, Walter H., Prokop, Gary F., Moy, King Y., Stilwell, Gary J., Nakayama, Joey G.
• Granted Patent: US 7,684,864 B2
• Time in Patent Office: Days
• US Class Current: 607/5
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence

Abstract

SubQ ICDs are disclosed that are entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and provide distributed cardioversion-defibrillation sense and stimulation electrodes for delivery of cardioversion-defibrillation shock and pacing therapies across the heart when necessary. Configurations include one hermetically sealed housing with 1 or, optionally, 2 subcutaneous sensing and cardioversion-defibrillation therapy delivery leads or alternatively, 2 hermetically sealed housings interconnected by a power/signal cable. The housings are generally dynamically configurable to adjust to varying rib structure and associated articulation of the thoracic cavity and muscles. Further the housings may optionally be flexibly adjusted for ease of implant and patient comfort.

Claims

1. A housing for a subcutaneous cardioverter defibrillator (SubQ ICD), the housing comprising:

an electrode having at least one of a proximal and distal location relative to the housing;

a fourth order elliptical structure forming a convex and concave opposing surface and further having a curvilinear edge around a perimeter thereof adapted for deployment in a subcutaneous location; and

a cardioversion defibrillation circuit within the housing and coupled to the electrode.

2. The housing of claim 1 wherein said proximal electrode includes an active-electrode on the housing.

3. The housing of claim 1 wherein at least one lead connector port on the housing is adapted to electrically couple the circuit to the distal electrode located at the end of a medical electrical lead.

4. The housing of claim 1 wherein said subcutaneous location includes the left anterior portion of a patient'"'"'s thorax between the patient'"'"'s third and sixth ribs.

5. The housing of claim 1 wherein said subcutaneous location includes one of a location adjacent a portion of latissimus dorsi muscle of the patient;

a location adjacent a portion of the external abdominal oblique muscle of the patient; and

a location adjacent an overlaying portion of the sternum of the patient.

6. The housing of claim 1 wherein said subcutaneous location includes one of a location adjacent or portion of a ______ major muscle of the patient;

a location associated with a portion of an infranginous muscle of the patient;

a location adjacent a portion of a teres minus muscle of the patient; and

a portion adjacent the cardiac notch of the patient.

7. A device adapted to provide cardioversion defibrillation, the device comprising:

a subcutaneously implantable cardioverter defibrillator (SubQ ICD) active-housing deice adapted to deliver anti-tachycardia therapy, said SubQ ICD further comprising;

an active electrode SubQ ICD housing adapted to conform to a first location adjacent at least a portion of a cardiac notch of a patient said SubQ ICD housing including at least one lead connector port electrically coupled to high energy defibrillation circuitry disposed within the SubQ ICD housing wherein two major opposing exterior faces of said SubQ ICD housing are disposed in a substantially parallel spaced-apart relations having a common lateral radius; and

at least one electrode adapted for deployment to a second location, wherein said second location establishes an energy vector with said active-electrode SubQ ICD housing and wherein said energy vector includes a majority of myocardial tissue of the patient.

8. An apparatus according to claim 7 wherein the cardiac notch comprises one of a subcutaneous and submuscular location adjacent the anterior area of the pericardium in direct contact with the sternum.

9. An apparatus according to claim 7 wherein the first location also includes a portion of one of the fourth and the fifth intercostals space of the patient.

10. An apparatus according to claim 9 wherein the first location also includes a location immediately medial to the midclavicular line.

11. An apparatus according to claim 7 wherein the first location also includes an overlapping portion of the sternum of the patient.

12. An apparatus according to claim 7 wherein the at least one electrode comprises an elongated metallic coil-type electrode.

13. An apparatus according to claim 12 wherein the elongated metallic coil-type electrode comprises a substantially isodiametric member with a length of between about 12 centimeters and 25 centimeters.

14. An apparatus according to claim 7 wherein the at least one electrode comprises at least one of:

at least two metallic coil-type electrodes, a patch type electrode, a subcutaneous electrode array, a mesh and a serpigneous array.

15. An apparatus according to claim 7 wherein the second location comprises one of:

a location adjacent a portion of a latissimus dorsi muscle of the patient;

a location adjacent a portion of a teres major muscle of the patient;

a location adjacent a portion of a teres major muscle of the patient;

a location associated with a portion of an infraspinous muscle of the patient; and

a location adjacent a portion of an external oblique muscle of the patient.

16. An apparatus according to claim 7 wherein the first location comprises one of a subcutaneous location and a submuscular location.

17. An apparatus according to claim 7 further comprising another electrode.

18. An apparatus according to claim 17 wherein the another electrode comprises one of:

a metallic coil-type electrode, a patch-type electrode, a paddle-type electrode, a mesh, a canister, and a serpigenous array.

19. An apparatus according to claim 18 wherein the another electrode provides an effective surface area approximately equal to the surface area of an 11 French elongated coil-type defibrillator coil having a length of between about 15 centimeters and 25 centimeters.

20. An apparatus according to claim 19 wherein the another electrode is disposed adjacent at least one of:

a location adjacent a portion of a latissimus dorsi muscle of the patient;

a location adjacent a portion of a teres major muscle of the patient;

a location adjacent a portion of a teres major muscle of the patient;

a location associated with a portion of an infraspinous muscle of the patient; and

a location adjacent a portion of an external oblique muscle of the patient.

21. An apparatus according to claim 7 wherein the active—

electrode SQ-ID housing comprises one of a metallic portion of said housing and said portion electrically couples to said high energy defibrillation circuitry and forms a discrete electrode wherein a dielectric material surrounds said discrete electrode.

22. An apparatus for delivering high-energy cardiac therapy to the myocardium of a patient, comprising:

means for determining a defibrillation threshold for a patient;

means for programming a defibrillation therapy energy output to a value above the determined defibrillation threshold;

means for detecting a potentially lethal cardiac arrhythmia of the patient; and

means for delivering a high-energy cardiac therapy to the myocardium of the patient along a therapy delivery vector lying between a first location and a second location in response to affirmative detection of the potentially lethal cardiac arrhythmia, wherein said therapy delivery vector includes a volume of myocardial tissue of a patient;

wherein the first location comprises one of a subcutaneous location and a submuscular location with each such location adjacent at least a portion of a cardiac notch of the patient; and

wherein the second location comprises one of;

a location associated with a portion of a latissimus dorsi muscle of the patient;

a location associated with a portion of a teres major muscle of the patient;

a location associated with a portion of a teres minor muscle of the patient, a location associated with a portion of an external oblique muscle of the patient, a location associated with a portion of an infraspinous muscle of the patient.

23. An apparatus according to claim 22 further comprising another electrode adapted to be disposed in one of a submuscular and a subcutaneous location and defining a unique therapy delivery vector between one of the first location and the second location, wherein said unique vector includes at least a portion of the myocardium of the patient.

24. An apparatus according to claim 23 further comprising:

means for automatically activating different therapy delivery vectors among the respective electrodes to render a plurality of sensing vector data sets representative of cardiac activity of the subject; and

means for comparing at least two of the plurality of sensing vector data sets.

25. An apparatus according to claim 24, further comprising:

means for utilizing a pair of the different pairs for subsequent sensing of cardiac activity of the subject based at least in part on the comparison of the sensing vector data sets.

26. An apparatus according to claim 25, further comprising:

means for storing in a memory structure at least one metric related to at least one pair of the different pairs.