Methods and apparatus for accessing and stabilizing an area of the heart

• US 20040088035A1
• Filed: 10/30/2002
• Published: 05/06/2004
• Est. Priority Date: 10/30/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: W. Guenst, Gary, Forest, Gerard C.
• Granted Patent: US 7,146,225 B2
• Time in Patent Office: Days
• US Class Current: 607/131
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

An epicardial lead installation tool having an elongated tool body extending between a tool body proximal and distal ends and encloses a tool body lumen. At least one suction pad supported by a suction pad strut extends distally to a distal end surface of the tool body distal end. A lead implantation tool extending between implantation tool proximal and distal ends is inserted through the tool body lumen to dispose the implantation tool distal end proximate to the tool body distal end. The lead implantation tool distal end is adapted to engage the distal electrode head of an epicardial lead to enable the extension of the assembly of the of the lead installation tool, the lead implantation tool and the epicardial lead through a skin incision and to apply the suction pad against the epicardium. Suction is applied through the suction pad to affix it to the epicardium while the implantation tool proximal end is manipulated to affix the distal fixation mechanism to the myocardium at the implantation site.

Claims

1. A method of implanting an epicardial lead into the myocardium at an epicardial implantation site accessed through the thorax from a skin incision, the epicardial lead of the type having an elongated lead body extending between at least one proximal electrical connector element and a distal fixation mechanism extending from a distal electrode head, the lead body supporting at least one distal pace/sense electrode coupled through an electrical conductor to a proximal electrical connector element, the method comprising:

affixing the distal electrode head to a distal end of a lead implantation tool of an epicardial lead installation tool, the epicardial lead installation tool having an elongated tool body enclosing a tool body lumen extending between a tool body proximal end and a tool body distal end, the lead implantation tool extending through the tool body lumen to a lead implantation tool proximal end, the tool body having at least one suction pad having at least one suction port supported by a suction pad strut extending distally from a distal end surface and a suction lumen for supplying suction to the suction port;

inserting the lead implantation tool and the epicardial lead through the skin incision to apply the suction pad against the epicardium;

applying suction through the suction port of the suction pad to fix the tool body to the epicardium;

manipulating the lead implantation tool to affix the distal fixation mechanism to the myocardium at the implantation site; and

halting the suction to withdraw the epicardial lead installation tool.

2. The method of claim 1, wherein at least one threshold measurement electrode is disposed upon the suction pad and an electrical connector extends from the threshold measurement electrode to a proximal electrical connector adapted to be coupled to a threshold measurement device external to the patient'"'"'s body and further comprising:

measuring at least one of the stimulation and sensing thresholds of the heart through the threshold measurement electrode applied to the epicardium in the step of applying suction to the epicardium.

3. The method of claim 2, wherein the tool body incorporates a light conductor adapted to be coupled to a light source external to the patient'"'"'s body and having at least one light-emitting window and further comprising:

emitting light transmitted through the light conductor from the light source through the light-emitting window to illuminate the implantation site.

4. The method of claim 3, wherein the epicardial lead installation tool comprises a tool handle extending laterally to the tool body and the step of inserting the tool body comprises grasping the tool handle to aim the tool body distal end from the skin incision in a direction toward an implantation site of interest;

5. The method of claim 1, wherein the tool body incorporates a light conductor adapted to be coupled to a light source external to the patient'"'"'s body and having at least one light-emitting window and further comprising:

emitting light transmitted through the light conductor from the light source through the light-emitting window to illuminate the implantation site.

6. The method of claim 1, wherein the epicardial lead installation tool comprises a tool handle extending laterally to the tool body and the step of inserting the tool body comprises grasping the tool handle to aim the tool body distal end from the skin incision in a direction toward an implantation site of interest.

7. The method of claim 1, wherein the distal fixation mechanism comprises a fixation helix, and the manipulating step comprises rotating the proximal end of the lead implantation tool in a screw-in direction to screw the distal fixation helix into the myocardium.

8. The method of claim 7, wherein the distal fixation helix is mounted to the distal electrode head to extend distally away from the distal electrode head in substantially axial alignment with the lead body, and the lead implantation tool comprises an introducer extending between an introducer proximal end and an introducer distal end and enclosing an introducer lumen, and wherein:

the affixing step comprises inserting the lead body through the introducer lumen to support the distal fixation helix extending distally away from the introducer distal end; and

the manipulating step comprises rotating and distally advancing the introducer proximal end to screw the distal fixation helix into the myocardium at the implantation site.

9. The method of claim 7, wherein the distal fixation helix is mounted to the distal electrode head to extend distally away from the distal electrode head at an acute angle to the lead body, and the lead implantation tool comprises releasable gripping tongs at the implantation tool distal end for engaging the electrode head, and wherein:

the affixing step comprises inserting the distal electrode head between the gripping tongs to support the distal fixation helix extending distally away from the implantation tool distal end; and

the manipulating step comprises rotating and distally advancing the implantation tool proximal end to screw the distal fixation helix into the myocardium at the implantation site.

10. The method of claim 9, wherein the affixing step further comprises wrapping the elongated lead body around the tool body.

11. The method of claim 9, further comprising the step of releasing the gripping tongs from the electrode head.

12. The method of claim 9, further comprising the step of simultaneously releasing the gripping tongs from the electrode head with the step of halting the suction.

13. The method of claim 1, further comprising the step of emitting light from the tool body distal end to illuminate the implantation site.

14. A system for implanting an epicardial lead into the myocardium at an epicardial implantation site accessed through the thorax from a skin incision, the epicardial lead of the type having an elongated lead body extending between at least one proximal electrical connector element and a distal fixation mechanism extending from a distal electrode head, the lead body supporting at least one distal pace/sense electrode coupled through an electrical conductor to a proximal electrical connector element, the system comprising:

an epicardial lead installation tool having an elongated tool body extending between a tool body proximal end and a tool body distal end and enclosing a tool body lumen extending to a distal end surface of the tool body distal end, at least one suction pad having at least one suction port and supported by a suction pad strut extending distally to the distal end surface;

a lead implantation tool extending between a lead implantation tool proximal end and a lead implantation tool distal end, the lead implantation tool extending through the tool body lumen to dispose the lead implantation tool distal end proximate to the tool body distal end, the lead implantation tool distal end adapted to engage the distal electrode head to enable the extension of the assembly of the of the lead installation tool, the lead implantation tool and the epicardial lead through the skin incision to apply the suction pad against the epicardium; and

means for applying suction through the suction lumen to fix the suction pad to the epicardium,

whereby the lead implantation tool proximal end is manipulable to affix the distal fixation mechanism to the myocardium at the implantation site.

15. The system of claim 14, wherein at least one threshold measurement electrode is disposed upon the suction pad and an electrical connector extends from the threshold measurement electrode to a proximal electrical connector adapted to be coupled to a threshold measurement device external to the patient'"'"'s body for measuring at least one of the stimulation and sensing thresholds of the heart through the threshold measurement electrode applied to the epicardium through suction.

16. The system of claim 14, wherein the tool body incorporates a light conductor adapted to be coupled to a light source external to the patient'"'"'s body and having at least one light-emitting window for emitting light transmitted through the light conductor from the light source through the light-emitting window to illuminate the implantation site.

17. The system of claim 14, wherein the epicardial lead installation tool further comprises a tool handle extending laterally to the tool body that can be manually grasped to aim the tool body distal end from the skin incision in a direction toward an implantation site of interest;

18. The system of claim 14, wherein the tool body incorporates a light conductor adapted to be coupled to a light source external to the patient'"'"'s body and having at least one light-emitting window for emitting light transmitted through the light conductor from the light source through the light-emitting window to illuminate the implantation site.

19. The system of claim 14, wherein the epicardial lead installation tool further comprises a tool handle extending laterally to the tool body that can be manually grasped to aim the tool body distal end from the skin incision in a direction toward an implantation site of interest;

20. The system of claim 14, wherein the distal fixation mechanism comprises a fixation helix that is adapted to be rotated through rotation of the proximal end of the lead implantation tool in a screw-in direction to screw the distal fixation helix into the myocardium.

21. The system of claim 20, further comprising a thumbwheel mounted to the proximal end of the lead implantation tool to facilitate rotation of the lead implantation tool within the tool body lumen.

22. The system of claim 21, wherein mating threads are formed between an outer surface of the lead implantation tool and an inner surface of the tool body lumen to enable controlled rotation and axial translation of the implantation tool with respect to the tool body lumen when the implantation tool proximal end is rotated.

23. The system of claim 20, wherein mating threads are formed between an outer surface of the lead implantation tool and an inner surface of the tool body lumen to enable controlled rotation and axial translation of the implantation tool with respect to the tool body lumen when the thumbwheel at the implantation tool proximal end is rotated.

24. The system of claim 14, wherein the distal fixation mechanism comprises a fixation helix mounted to the distal electrode head to extend distally away from the distal electrode head in substantially axial alignment with the lead body, and the lead implantation tool comprises an introducer extending between an introducer proximal end and an introducer distal end and enclosing an introducer lumen through which the lead body can be extended with the distal fixation helix extending distally away from the introducer distal end in proximity to the tool body distal end, whereby the introducer proximal end is rotatable to screw the distal fixation helix into the myocardium at the implantation site.

25. The system of claim 24, further comprising a thumbwheel mounted to the introducer proximal end to facilitate rotation of the lead implantation tool within the tool body lumen.

26. The system of claim 25, wherein mating threads are formed between an outer surface of the introducer and an inner surface of the tool body lumen to enable controlled rotation and axial translation of the introducer with respect to the tool body lumen when the introducer proximal end is rotated.

27. The system of claim 24, wherein mating threads are formed between an outer surface of the lead introducer and an inner surface of the tool body lumen to enable controlled rotation and axial translation of the introducer with respect to the tool body lumen when the thumbwheel at the introducer proximal end is rotated.

28. The system of claim 14, wherein:

the distal fixation mechanism comprises a fixation helix mounted to the distal electrode head to extend distally away from the distal electrode head at an acute angle to the lead body

the lead implantation tool comprises releasable gripping tongs at the implantation tool distal end movable into a position that engages the electrode head to support the distal fixation helix extending distally away from the implantation tool distal end and movable into a position that releases the electrode head.

29. The system of claim 28, further comprising a thumbwheel mounted to the proximal end of the lead implantation tool to facilitate rotation of the lead implantation tool within the tool body lumen and the rotation of the tongs to screw the distal fixation helix into the myocardium.

30. The system of claim 29, wherein mating threads are formed between an outer surface of the lead implantation tool and an inner surface of the tool body lumen to enable controlled rotation and axial translation of the implantation tool with respect to the tool body lumen when the implantation tool proximal end is rotated.

31. The system of claim 28, wherein mating threads are formed between an outer surface of the lead implantation tool and an inner surface of the tool body lumen to enable controlled rotation and axial translation of the implantation tool with respect to the tool body lumen when the thumbwheel at the implantation tool proximal end is rotated.

32. The system of claim 31, wherein the implantation tool further comprises means for releasing the gripping tongs from the electrode head.

33. The system of claim 28, wherein the implantation tool further comprises means for releasing the gripping tongs from the electrode head.

34. The system of claim 28, wherein the implantation tool further comprises means for simultaneously releasing the gripping tongs from the electrode head and halting the application of suction through the at least one suction port.

35. The system of claim 14, further comprising means for emitting light from the tool body distal end to illuminate the implantation site.