Implantable lead and coronary venous pressure sensor apparatus and method

• US 8,594,792 B2
• Filed: 11/30/2012
• Issued: 11/26/2013
• Est. Priority Date: 08/12/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Liu, Lili, Krishnan, Mohan, Wulfman, David R., Tockman, Bruce A
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US13/690,068
• Publication Number:
  US 20130090701A1
• Time in Patent Office: 361 Days
• Field of Search: 607 23- 25
• US Class Current: 607/23
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A cardiac rhythm management system comprises a medical electrical lead, a pressure sensing element, and an implantable pulse generator. The lead is sized to be advanced through the right atrium and coronary sinus into a coronary vein adjacent to the left ventricle. The lead includes an opening intermediate its proximal and distal ends, and a lumen extending longitudinally within the body in communication with the opening. The pressure sensing element is movably disposed in lead lumen and is dimensioned to extend through the opening in the lead, and includes a flexible, elongated conductive member having a distal end, and a pressure transducer coupled to the distal end of the conductive member. The pulse generator is configured to receive cardiac rhythm signals from the electrode and fluid pressure signals from the pressure transducer.

Claims

1. A method of optimizing implant parameters for an implantable cardiac rhythm management system including an implantable pulse generator and a coronary venous lead, the coronary venous lead including:

an elongate, flexible lead body made of an electrically insulative material, the body having a proximal end and a distal end, the body being sized to permit the distal end to be advanced through a right atrium and a coronary sinus and into a first coronary vein adjacent to a left ventricle of a patient'"'"'s heart;

a first opening in the body at a point intermediate the proximal and distal ends;

a lumen extending longitudinally within the lead body and in communication with the first opening; and

at least one pace/sense electrode coupled to the body proximate the distal end, the method comprising;

positioning the electrode within the first coronary vein adjacent the left ventricle;

operatively coupling the electrode to the implantable pulse generator or a pacing system analyzer device;

deploying a pressure transducer through the lumen and out the first opening in the lead so as to position the pressure transducer in the first coronary vein or a second coronary vein;

generating an acute baseline pressure waveform based on an output signal from the pressure transducer over a plurality of cardiac cycles;

applying an electrical stimulus to the left ventricle through the electrode using the implantable pulse generator or the pacing system analyzer; and

adjusting one or more CRM system parameters while monitoring changes in the pressure waveform relative to the baseline.

2. The method of claim 1 wherein adjusting one or more CRM system parameters includes relocating the electrode to a second location within the first coronary vein, the second coronary vein, or a third coronary vein.

3. The method of claim 1 wherein adjusting one or more CRM system parameters includes adjusting A-V delay and/or V-V delay.

4. The method of claim 1 wherein adjusting one or more CRM system parameters further includes adjusting one or more CRM system parameters while monitoring changes in mechanical timing in addition to changes in the pressure waveform relative to the baseline.

5. The method of claim 1 wherein a portion of the lead is pre-formed into a helical shape defining an interior space, and wherein the pressure transducer is deployed through the first opening and positioned within the interior space.

6. The method of claim 1 wherein the lead includes a plurality of openings at selected locations along the lead body, and the pressure transducer may be deployed out through any of the plurality of openings.

7. A method of optimizing implant parameters for an implantable cardiac rhythm management system including an implantable pulse generator and a coronary venous lead, the coronary venous lead including:

an elongate, flexible lead body made of an electrically insulative material, the body having a proximal end and a distal end, the body being sized to permit the distal end to be advanced through a right atrium and a coronary sinus and into a first coronary vein adjacent to a left ventricle of a patient'"'"'s heart;

a first opening in the body at a point intermediate the proximal and distal ends;

a lumen extending longitudinally within the lead body and in communication with the first opening; and

at least one pace/sense electrode coupled to the body proximate the distal end, the method comprising;

positioning the electrode within the first coronary vein adjacent the left ventricle;

operatively coupling the electrode to the implantable pulse generator or a pacing system analyzer device;

deploying a pressure transducer through the lumen and adjacent the first opening in the lead;

generating an acute baseline pressure waveform based on an output signal from the pressure transducer over a plurality of cardiac cycles;

applying an electrical stimulus to the left ventricle through the electrode using the implantable pulse generator or the pacing system analyzer; and

adjusting one or more CRM system parameters while monitoring changes in the pressure waveform relative to the baseline.

8. The method of claim 7 wherein the lead includes a plurality of openings at selected locations along the lead body, and the pressure transducer may be deployed adjacent any of the plurality of openings.

9. The method of claim 7 wherein adjusting one or more CRM system parameters includes relocating the electrode to a second location within the first coronary vein, the second coronary vein, or a third coronary vein.

10. The method of claim 7 wherein adjusting one or more CRM system parameters includes adjusting A-V delay and/or V-V delay.

11. The method of claim 7 wherein adjusting one or more CRM system parameters further includes adjusting one or more CRM system parameters while monitoring changes in mechanical timing in addition to changes in the pressure waveform relative to the baseline.