IMPLANTATION OF AN ACTIVE MEDICAL DEVICE USING THE INTERNAL THORACIC VASCULATURE

• US 20180036527A1
• Filed: 08/02/2017
• Published: 02/08/2018
• Est. Priority Date: 08/05/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: REDDY, G. SHANTANU, GILKERSON, JAMES O., DE KOCK, ANDREW L., CAWTHRA, JR., JAMES K., HAMMILL, ERIC
• Granted Patent: US 10,576,267 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• 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 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Implantable devices and systems include one or more leads adapted to be emplaced in the internal thoracic vein (ITV) of a patient. The lead may include features to adapt the lead for such placement. An associated device for use with the lead may include operational circuitry adapted for use with a lead having an electrode for sensing and/or therapy purposes coupled thereto. Methods for implantation and use of such devices and systems are disclosed as well.

Claims

1. An implantable cardiac therapy system comprising:

a first lead configured for placement in an internal thoracic vein (ITV) of a patient, the first lead comprising at least a first electrode thereon for therapy delivery; and

an implantable canister for coupling to the first lead, the implantable canister housing operational circuitry configured to deliver output therapy in the form of at least one of bradycardia pacing, anti-tachycardia pacing, cardiac resynchronization therapy, or defibrillation, using at least the first electrode with the first lead in the ITV.

2. The system of claim 1 wherein the operational circuitry comprises a charger and capacitor bank adapted for use in delivering defibrillation via the ITV and having an adjustable output energy in the range of about 10 to about 60 joules.

3. The system of claim 1 wherein the operational circuitry comprises a pace therapy delivery circuit having a pace current output in the range of about 10 to about 50 milliamps.

4. The system of claim 1 wherein the operational circuitry comprises a pace therapy delivery circuit having an output voltage in the range of about 10 to about 30 volts.

5. The system of claim 1 wherein the first lead is configured for placement with a first portion in the ITV and with a second portion in an intercostal vein of the patient, by having an outer diameter in the range of about 2 to about 6 French.

6. The system of claim 1, further comprising:

a second lead having a second electrode for therapy delivery purposes, the second lead adapted to place the second electrode in a selected one of the azygos, hemiazygos, or accessory hemiazygos veins;

wherein the operational circuitry is configured to deliver therapy when the first electrode is disposed in the ITV and the second electrode is disposed in the selected one of the azygos, hemiazygos, or accessory hemiazygos veins.

7. The system of claim 6 wherein the implantable canister and first and second leads are adapted to facilitate placement of the canister in a location near the clavicle such that the first and second leads enter and pass through at least a portion of a brachiocephalic vein.

8. The system of claim 6 wherein the implantable canister and first and second leads are adapted to facilitate placement of the canister in the left axilla such that the first and second leads enter and pass through one or more intercostal veins.

9. The system of claim 6 wherein the first lead comprises a third therapy delivery electrode, and the operational circuitry is configured to shape therapy delivery to target a desired portion of the heart using the first, second and third electrodes.

10. The system of claim 6 wherein the second lead comprise a third therapy delivery electrode, and the operational circuitry is configured to shape therapy delivery to target a desired portion of the heart using the first, second and third electrodes.

11. A method of implanting a first lead for use in a cardiac stimulus system in a patient, the first lead having at least one electrode thereon;

the method comprising inserting the first lead into the internal thoracic vein (ITV) to a desired location relative to the heart of a patient.

12. The method of claim 11 further comprising establishing access to a brachiocephalic vein of the patient and advancing a distal portion of the first lead through the ostium of the ITV from the brachiocephalic vein.

13. The method of claim 11 further comprising establishing access to the ITV through an intercostal space between two ribs including:

inserting a needle into one of the ITV through the intercostal space; and

advancing a sheath into the intercostal space and into the ITV; and

wherein the step of inserting the lead comprises advancing the distal end of the first lead through the sheath and intro the ITV.

14. The method of claim 11 further comprising establishing access to the superior epigastric vein at a location inferior to the lower rib margin and introducing the first lead through the epigastric vein and superiorly into the ITV.

15. The method of claim 11 further comprising establishing access to the musculophrenic vein at the lower rib margin and introducing the first lead through the musculophrenic vein and superiorly into the ITV.

16. The method of claim 11 further comprising inserting a second lead having at least one electrode thereon into at least one of the azygos, hemiazygos, and accessory hemiazygos veins to a desired location relative to the heart of the patient, to establish a therapy vector between an electrode on the first lead and an electrode on the second lead passing at least partially anterior-posterior through the heart.

17. The method of claim 11 wherein the first lead is implanted into the left ITV, and the method further comprises inserting a second lead having at least one electrode thereon into the right ITV to a desired location relative to the heart of the patient.

18. A method of implanting a cardiac stimulus system comprising:

performing the method of claim 11 to implant a lead in a patient;

implanting a pulse generator in the patient; and

coupling the lead to the pulse generator.

19. A method of treating a patient comprising delivering therapy between a first electrode disposed on a lead which is placed in an internal thoracic vein (ITV) and at least a second electrode.

20. A method as in claim 19 wherein the second electrode is disposed on an internal pulse generator also implanted in the patient.