Implantation of an active medical device using the internal thoracic vasculature

• US 10,576,267 B2
• Filed: 08/02/2017
• Issued: 03/03/2020
• 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
• Primary Examiner(s): Lee, Erica S
• Application Number:
  US15/667,167
• Publication Number:
  US 20180036527A1
• Time in Patent Office: 944 Days
• Field of Search: None
• 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. 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 a selected one of left and right internal thoracic veins (ITV) to a desired location relative to the heart of a patient;

further comprising establishing percutaneous access to the musculophrenic vein at the lower rib margin and introducing the first lead through the musculophrenic vein and superiorly into the selected ITV.

2. The method of claim 1 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.

3. The method of claim 1 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.

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

performing the method of claim 1 to implant a lead in a patient;

implanting a pulse generator in the patient at a subcutaneous location; and

coupling the lead to the pulse generator.

5. The method of claim 1, wherein the first lead includes a plurality of electrodes including at least one ring or tip electrode and at least one coil electrode, wherein at least some of the plurality of electrodes are positioned in a distal electrode region of the first lead, wherein the first lead is inserted into the selected ITV to a position in which the distal electrode region extends at least between a top and a bottom of the patient'"'"'s heart.

6. The method of claim 5, wherein the at least one ring or tip electrode is a sensing electrode and the at least one coil electrode is a pacing electrode.

7. The method of claim 5, wherein the plurality of electrodes includes at least two coil electrodes and at least two ring or tip electrodes.

8. The method of claim 7, wherein the at least two coil electrodes are spaced apart along the first lead and at least one ring electrode is disposed between the at least two coil electrodes.

9. The method of claim 5, 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, wherein the at least one electrode on the second lead is positioned in a second distal electrode region of the second lead, wherein the second lead is inserted into the right ITV to a position in which the second distal electrode region extends at least between the top and bottom of the patient'"'"'s heart.

10. 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:

establishing access to a selected one of the left and right internal thoracic veins (ITV) through an intercostal space between two ribs including;

inserting a needle into the selected ITV through the intercostal space; and

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

advancing a distal end of the first lead through the sheath and into the selected ITV; and

inserting the first lead into the selected ITV to a desired location relative to the heart of a patient.

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:

establishing percutaneous access to a superior epigastric vein at a location inferior to the lower rib margin;

introducing the first lead through the epigastric vein and superiorly into a selected one of the left and right internal thoracic veins (ITV); and

inserting the first lead into the selected ITV to a desired location relative to the heart of a patient.