Arrangement for implanting an endocardial cardiac lead

• US 6,132,456 A
• Filed: 03/10/1998
• Issued: 10/17/2000
• Est. Priority Date: 03/10/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lodes, Michael P., Sommer, John L.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/041,073
• Time in Patent Office: 952 Days
• Field of Search: 607/119, 607/122, 607/125-128, 607/116, 600/374, 600/375, 600/585, 606/129, 606/108
• US Class Current: 607/127
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/058 Fixing tools
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

An arrangement for transvenously introducing and fixing a cardiac electrode at a cardiac implantation site. The arrangement includes a pusher having an elongated body of flexible material, which may be coupled with a cardiac lead adjacent the distal end of the cardiac lead and may be employed to advance the cardiac lead transvenously. The pusher is provided with an engagement mechanism which engages the distal end of the cardiac lead while the lead extends proximally along side the exterior surface of the pusher and which engages the distal end of the lead body when the pusher body is advanced distally and disengages from the cardiac lead body when the pusher is withdrawn proximally. The pusher body has sufficient column strength to be advanced through a patient'"'"'s venous system to a desired implantation site within the heart. The cardiac lead may include a fixation helix extending from the distal end of the lead and the pusher body may be employed to apply torque to the distal end of the lead to screw the helix into cardiac tissue at a desired implantation site.

Claims

1. An arrangement to facilitate the introduction and advancement of an endocardial cardiac lead, comprising:

an endocardial cardiac lead including a lead body having a lead body diameter and extending between a proximal lead end and a distal lead end, a lead conductor extending within said lead body between said proximal and distal lead ends, and a cardiac electrode at or adjacent said distal lead end electrically connected to said lead conductor;

pusher means for engaging and advancing said cardiac lead transvenously, said pusher means further comprising;

an elongated pusher body having a pusher body exterior surface and extending between a proximal pusher body end and a distal pusher body end and formed of flexible material having sufficient column strength to be advanced transvenously with the cardiac lead body extending alongside said pusher body exterior surface; and

cardiac lead engaging means coupled with said distal pusher body end for engaging the cardiac lead at or adjacent the distal lead end while said lead body extends alongside said pusher body exterior surface; and

wherein said lead comprises cooperative engagement means formed at said distal lead end of said cardiac lead for engaging with said cardiac lead engaging means responsive to force applied to the pusher body to advance said pusher body distally and for disengaging from said cardiac lead engaging means at said distal lead end responsive to retraction of the pusher body proximally.

2. The arrangement of claim 1, wherein said pusher body is a torque cable.

3. The arrangement of claim 1, wherein said pusher body is rod or wire shaped and said cardiac lead engaging means is a tubular sleeve having a side wall surrounding a sleeve lumen extending between a proximal sleeve lumen opening and a distal sleeve lumen opening and formed to receive said distal lead end.

4. The arrangement of claim 3, wherein said pusher body is a torque cable.

5. The arrangement of claim 3, wherein said pusher body is a torque cable coated with an elastomeric compound.

6. The arrangement of claim 3, wherein said pusher body is coated with an elastomeric compound.

7. The arrangement of claim 1, wherein:

said cooperative engagement means comprises a shaped portion of said distal lead end; and

said cardiac lead engaging means formed at said distal pusher body end is of a shape which interlocks with said shaped portion of said distal lead end to allow said distal lead end to be advanced with advancement of said pusher body distally and to allow said shaped portion to disengage from said cardiac lead engagement means upon retraction of the pusher body and tubular sleeve proximally.

8. The arrangement of claim 7, further comprising at least one lead retainer located along the length of and fixed to said pusher body intermediate said proximal pusher body end and said distal pusher body end, each lead retainer having a lead body receiving slot that is dimensioned with respect to said lead body diameter to receive and loosely retain said lead body alongside said pusher body.

9. The arrangement of claim 1, wherein:

said pusher body is rod or wire shaped; and

said cardiac lead engaging means extends distally from said rod or wire shaped distal pusher body end and further comprises;

a tubular sleeve having a side wall surrounding a sleeve lumen extending between a proximal sleeve lumen opening and a distal sleeve lumen opening, said sleeve lumen dimensioned to receive said distal lead end therein; and

retention means engageable with said cooperative engagement means of said distal lead end in said sleeve lumen, for preventing said distal lead end from retracting proximally and out of said proximal sleeve lumen opening as said pusher body and said cardiac lead body are advanced distally and allowing said distal lead end to be released distally from said distal sleeve lumen opening upon retraction of said pusher body proximally.

10. The arrangement of claim 9, wherein said tubular sleeve is split to form a breech extending between said proximal sleeve lumen opening and said distal sleeve lumen opening having a breech width that is wide enough to allow a section of said lead body proximal to said distal lead end to be laterally inserted through said breech and into said sleeve lumen.

11. The arrangement of claim 10, wherein:

said cooperative engagement means comprises a shaped portion of said distal lead end; and

said cardiac lead engaging means formed at said distal pusher body end is formed in said tubular sleeve in a shape which interlocks with said shaped portion of said distal lead end while said distal lead end is received in said sleeve lumen to allow said distal lead end to be advanced with advancement of said pusher body and to allow said shaped portion to disengage from said cardiac lead engagement means upon retraction of the pusher body and tubular sleeve.

12. The arrangement of claim 9, wherein:

said distal lead end is formed at least in part with a distal lead end side wall having a distal lead end diameter that exceeds said lead body diameter and said breech width and fits within said sleeve lumen;

said retention means comprises a lead retention slot extending proximally a predetermined distance in the sleeve side wall from the distal sleeve lumen opening; and

said cooperative engagement means comprises a key extending outward of said distal lead end side wall and dimensioned to be received and seated in said lead retention slot following insertion of said lead body through said breech and into said sleeve lumen, alignment of said key with said lead retention slot, and retraction of said distal lead end into said distal sleeve lumen opening to draw said key into said lead retention slot.

13. The arrangement of claim 1, further comprising at least one lead retainer located along the length of and fixed to said pusher body intermediate said proximal pusher body end and said distal pusher body end, each lead retainer having a lead body receiving slot that is dimensioned with respect to said lead body diameter to receive and loosely retain said lead body alongside said pusher body.

14. A method of introducing and advancing the arrangement of claim 1 comprising:

fitting said cooperative engagement means formed at said distal lead end of said cardiac lead into engagement with said cardiac lead engaging means;

applying force to the pusher body to advance said pusher body and said cardiac lead body distally to a cardiac implantation site;

disengaging said cardiac lead engaging means from said lead cooperative engagement means; and

retracting said pusher body.

15. An arrangement to facilitate the introduction and advancement of an endocardial cardiac lead, comprising:

an endocardial cardiac lead including a lead body having a lead body diameter and extending between a proximal lead end and a distal lead end, a lead conductor extending within said lead body between said proximal and distal lead ends, a cardiac electrode at or adjacent said distal lead end electrically connected to said lead conductor, and an active fixation helix extending distally from said distal lead end;

pusher means for engaging and advancing said cardiac lead transvenously, said pusher means comprising;

an elongated pusher body having a pusher body exterior surface and extending between a proximal pusher body end and a distal pusher body end formed of flexible material having sufficient column strength to be advanced transvenously with the cardiac lead body extending alongside said pusher body exterior surface;

cardiac lead engaging means coupled with said distal pusher body end for engaging the cardiac lead at or adjacent the distal lead end while said lead body extends alongside said pusher body exterior surface; and

wherein said lead comprises cooperative engagement means formed at the distal lead end thereof for engaging with said cardiac lead engaging means responsive to force applied to the pusher body to advance said pusher body distally and for transmitting torque to said helix and adapted to screw said helix into cardiac tissue upon rotation of said pusher body and for disengaging from said cardiac lead engaging means at said distal lead end upon retraction of the pusher body proximally.

16. The arrangement of claim 15, wherein:

said pusher body is rod or wire shaped; and

said cardiac lead engaging means extends distally from said rod or wire shaped distal pusher body end and further comprises a tubular sleeve having a side wall surrounding a sleeve lumen extending between a proximal sleeve lumen opening and a distal sleeve lumen opening, said sleeve lumen dimensioned to receive said distal lead end therein.

17. The arrangement of claim 16, wherein:

said cooperative engagement means comprises a shank portion of said helix extending radially from said distal lead end and connecting said helix with said distal lead end; and

said tubular sleeve further comprises retention means for engaging said shank portion in said sleeve lumen to prevent said distal lead end and helix from retracting proximally and out of said proximal sleeve lumen opening as said pusher body and said cardiac lead body are advanced proximally and transmitting torque to said helix upon rotation of said pusher body end and allowing said distal lead end to be released distally from said distal sleeve lumen opening upon retraction of said pusher body proximally.

18. The arrangement of claim 17, wherein said tubular sleeve is split to form a breech extending between said proximal sleeve lumen opening and said distal sleeve lumen opening having a breech width that is wide enough to allow a section of said lead body proximal to said distal lead end to be laterally inserted through said breech and into said sleeve lumen.

19. The arrangement of claim 18, wherein:

said distal lead end is formed at least in part with a distal lead end side wall having a distal lead end diameter that exceeds said lead body diameter and said breech width and fits within said sleeve lumen to present said helix extending distally from said distal sleeve lumen opening; and

said retention means comprises a lead retention slot extending proximally a predetermined distance in the sleeve side wall from the distal sleeve lumen opening; and

wherein;

said shank portion extends outward of said distal lead end side wall and is dimensioned to be received and seated in said lead retention slot following insertion of said lead body through said breech and into said sleeve lumen, alignment of said shank portion with said lead retention slot, and retraction of said distal lead end into said distal sleeve lumen opening to draw said shank portion into said lead retention slot.

20. The arrangement of claim 15, further comprising at least one lead retainer located along the length of and fixed to said pusher body intermediate said proximal pusher body end and said distal pusher body end, each lead retainer having a lead body receiving slot that is dimensioned with respect to said lead body diameter to receive and loosely retain said lead body alongside said pusher body.

21. A method of introducing and advancing the arrangement of claim 18 comprising:

fitting said cooperative engagement means formed at said distal lead end of said cardiac lead into engagement with said cardiac lead engaging means;

applying force to the pusher body to advance said pusher body and said cardiac lead body distally to a cardiac implantation site;

transmitting torque to said helix to screw said helix into cardiac tissue;

disengaging said cardiac lead engaging means from said lead cooperative engagement means; and

retracting said pusher body.