PACING CATHETER WITH STENT ELECTRODE

• US 20090318989A1
• Filed: 06/15/2009
• Published: 12/24/2009
• Est. Priority Date: 06/19/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hastings, Roger, Eidenschink, Tracee, Tomaschko, Daniel K., Olson, Richard J., Broman, David James
• Granted Patent: US 8,639,357 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Cardioprotective pacing is applied to prevent and/or reduce cardiac injury associated with myocardial infarction (MI) and revascularization procedure. Pacing pulses are generated from a pacemaker and delivered through one or more pacing electrodes incorporated onto one or more percutaneous transluminal vascular intervention (PTVI) devices during the revascularization procedure. In one embodiment, at least one pacing electrode is constructed as, or incorporated onto, a stent at a distal end portion of a stent catheter.

Claims

1. A percutaneous transluminal vascular intervention (PTVI) device assembly for use during revascularization of a blood vessel, the PTVI device assembly comprising:

a stent catheter including a catheter proximal end portion, a catheter distal end portion, an elongate catheter shaft coupled between the catheter proximal end portion and the catheter distal end portion, a stent connected to the catheter distal end portion and including a first pacing electrode, a first connector at the catheter proximal end portion, and a first conductor electrically connecting the first pacing electrode to the first connector;

a sheath including a sheath proximal opening and a sheath distal opening, the sheath configured to accommodate a portion of the stent catheter and allow the stent to exit through the distal opening; and

a pacemaker configured to be connected to the first connector, the pacemaker including;

a pacing output circuit configured to deliver pacing pulses through the first pacing electrode; and

a control circuit coupled to the pacing output circuit and configured to execute a cardioprotective pacing protocol specifying one or more cardiac protection pacing sequences each including alternating pacing and non-pacing periods, the pacing periods each having a pacing duration during which a plurality of the pacing pulses is delivered, the non-pacing periods each having a non-pacing duration during which none of the pacing pulses is delivered.

2. The PTVI device assembly of claim 1, wherein the sheath comprises a guide catheter.

3. The PTVI device assembly of claim 1, wherein the stent catheter comprises a stent delivery catheter, and the stent is detachably connected to the catheter distal end portion.

4. The PTVI device assembly of claim 3, comprising a dissolvable connector connecting between the stent and the catheter distal end portion, the dissolvable connector being electrically conductive and dissolvable by electrolysis after being exposed to blood.

5. The PTVI device assembly of claim 1, wherein the stent is configured to self-expand upon exiting the sheath distal opening.

6. The PTVI device assembly of claim 5, wherein the stent is configured to be retractable into the sheath through the sheath distal opening.

7. The PTVI device assembly of claim 1, comprising a second pacing electrode, a second connector, and a second conductor electrically connecting the second pacing electrode to the second connector, and wherein the pacemaker is configured to be connected to the first connector and the second connector.

8. The PTVI device assembly of claim 7, wherein the stent catheter comprises the second pacing electrode, and the catheter proximal end portion comprises the second connector.

9. The PTVI device assembly of claim 8, wherein the stent comprises the first pacing electrode and the second pacing electrode.

10. The PTVI device assembly of claim 8, wherein the stent comprises a mesh, the first pacing electrode comprises a first metal portion of the mesh, and the second pacing electrode comprises a second metal portion of the mesh, the second metal portion insulated from the first metal portion.

11. The PTVI device assembly of claim 8, wherein the second pacing electrode is incorporated onto the catheter shaft.

12. The PTVI device assembly of claim 7, comprising a guide wire including a guide wire proximal end portion including the second connector, a guide wire distal end portion including the second pacing electrode, and an elongate guide wire shaft coupled between the guide wire proximal end portion and the guide wire distal end portion, and wherein the stent catheter comprises a catheter lumen extending within the catheter shaft between the catheter proximal end portion and the catheter distal end portion, the catheter lumen configured to accommodate a portion of the guide wire.

13. The PTVI device assembly of claim 12, wherein the second pacing electrode is incorporated onto the guide wire.

14. The PTVI device assembly of claim 7, wherein the second pacing electrode is incorporated onto the sheath.

15. A method for cardioprotective pacing during revascularization of a blood vessel, the method comprising:

delivering pacing pulses using a stent connected to a percutaneous transluminal stent catheter including a portion placed in a sheath, the stent including a first pacing electrode; and

controlling the delivery of the pacing pulses by executing a cardioprotective pacing protocol specifying one or more cardiac protection pacing sequences each including alternating pacing and non-pacing periods, the pacing periods each having a pacing duration during which a plurality of the pacing pulses is delivered, the non-pacing periods each having a non-pacing duration during which none of the pacing pulses is delivered.

16. The method of claim 15, comprising disconnecting the stent from the stent catheter after the delivery of the pacing pulses, the stent remaining in the blood vessel after the disconnection.

17. The method of claim 16, wherein disconnecting the stent from the stent catheter comprises using a connector that is dissolvable by electrolysis when exposed to blood.

18. The method of claim 15, comprising expanding the stent by pulling the sheath such that the first pacing electrode exits the sheath before the delivery of the pacing pulses.

19. The method of claim 18, comprising contacting the first pacing electrode by pushing the sheath such that the first pacing electrode retracts into the sheath after the delivery of the pacing pulses.

20. The method of claim 15, wherein delivering the pacing pulses comprises delivering the pacing pulses using a stent including the first pacing electrode and a second pacing electrode.

21. The method of claim 15, wherein delivering the pacing pulses comprises delivering the pacing pulses through the first pacing electrode and a second pacing electrode incorporated onto a shaft of the stent catheter.

22. The method of claim 15, wherein delivering the pacing pulses comprises delivering the pacing pulses through the first pacing electrode and a second pacing electrode incorporated onto the sheath.

23. The method of claim 15, wherein delivering the pacing pulses comprises delivering the pacing pulses through the first pacing electrode and a second pacing electrode incorporated onto a guide wire, and wherein the stent catheter comprises a lumen accommodating a portion of the guide wire.