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

• US 7,146,225 B2
• Filed: 10/30/2002
• Issued: 12/05/2006
• Est. Priority Date: 10/30/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Guenst, Gary W., Forest, Gerard C.
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Kramer, Nicole R.
• Application Number:
  US10/283,794
• Publication Number:
  US 20040088035A1
• Time in Patent Office: 1,497 Days
• Field of Search: 607/119, 607/122, 607126-132, 600/374, 600386- 7
• US Class Current: 607/119
• 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 having an inner surface and an outer surface, the inner surface of the 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 installation tool body lumen such that the distal end of the implantation tool extends out from a distal end opening of the lumen to be disposed adjacent to a suction pad strut of the installation tool, the strut extending distally from the installation tool body distal end to a suction pad supported by the strut, the suction pad having at least one suction port;

grasping a handle of the installation tool to insert the electrode head, affixed to the lead implantation tool, through the skin incision, and to apply the suction pad against the epicardium;

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

rotating a thumbwheel coupled to a proximal end of the implantation tool with a same hand that still grasps the handle, after applying suction, to advance the implantation tool within the lumen of the installation tool body a distance defined by a threaded engagement between an outer surface of the implantation tool and the inner surface of the installation tool body, and, thereby, affixing manipulating the lead the distal fixation mechanism to the myocardium at the implantation site.

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.

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 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.

5. The method of claim 1, wherein:

the affixing step comprises inserting the distal electrode head between releasable gripping tongs comprising the distal end of the implantation tool.

6. The method of claim 5, further comprising the step of releasing the gripping tongs from the electrode head.

7. The method of claim 1, wherein the affixing step comprises wrapping the elongated lead body around the installation tool body.

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

9. 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 including;

an elongated tool body having an outer wall, an inner surface of the outer wall enclosing a tool body lumen extending between a tool body proximal end and a tool body distal end,

at least one suction pad strut extending distally from the outer wall in proximity to a distal end opening of the lumen to terminate in a suction pad that extends through an arc about a longitudinal axis of the lumen, the suction pad having a distal facing surface including at least one suction port, and

a suction lumen extending longitudinally within the outer wall of the tool body between the tool body proximal end and the at least one suction port;

a lead implantation tool including a proximal end and a distal end, the implantation tool extending through the installation tool body lumen such that the lead implantation tool distal end extends out the distal end opening of the lumen to be disposed adjacent the at least one suction pad strut, the lead implantation tool distal end adapted to engage the distal electrode head and the lead implantation tool proximal end being manipulable to affix the distal fixation mechanism at the implantation site, wherein mating threads are formed between an outer surface of the lead implantation tool and the inner surface of the installation tool body outer wall to enable controlled rotation and axial translation of the implantation tool with respect to the installation tool body lumen when the implantation tool proximal end is rotated; and

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

10. The system of claim 9, 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.

11. The system of claim 9, 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.

12. The system of claim 9, 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.

13. The system of claim 9, 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.

14. The system of claim 13, 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.

15. The system of claim 14, wherein mating threads are formed between an outer surface of the lead implantation tool and the inner surface of the installation tool body outer wall to enable controlled rotation and axial translation of the implantation tool with respect to the installation tool body lumen when the thumbwheel is rotated.

16. The system of claim 9, wherein:

the distal end of the lead implantation tool comprises releasable gripping tongs movable into a first position that engages the electrode head and movable into a second position that releases the electrode head.

17. The system of claim 16, wherein the implantation tool further includes means for simultaneously releasing the gripping tongs from the electrode head and halting the application of suction through the suction lumen.

18. The system of claim 9, further comprising means for emitting light from the tool body distal end to illuminate the implantation site.

19. The system of claim 18, wherein the means for emitting light comprises an external light source coupled to a light conductor and extending from the light source, along the installation tool body, to a window disposed in proximity to the tool body distal end.

20. The system of claim 19, wherein the window extends around the distal end opening of the tool body lumen.

21. The system of claim 19, wherein the window is formed by a transparent portion of the at least one suction pad strut.

22. The system of claim 19, wherein the window is formed by a transparent portion of the suction pad.

23. The system of claim 9, wherein the at least one suction pad strut is flexible to bend away from the longitudinal axis of the tool body lumen when loaded by an applied force.

24. The system of claim 9, wherein the arc through which the suction pad extends is approximately 45 degrees.

25. The system of claim 9, wherein the arc through which the suction pad extends is approximately 270 degrees.

26. The system of claim 9, wherein the arc through which the suction pad extends is approximately 360 degrees.

27. The system of claim 9, wherein the at least one suction pad strut comprises a pair of suction pad struts extending from the outer wall on opposing sides of the distal end opening of the installation tool body lumen.

28. The system of claim 9, wherein the distal facing surface of the suction pad is concave.

29. An epicardial lead implant system comprising:

an elongated implantation tool including a proximal end, a distal end adapted to reversibly engage an electrode head of an epicardial lead, a thumbwheel disposed in proximity to the proximal end, and an outer surface including a threaded portion; and

an elongated installation tool including a proximal end, a distal end, an outer wall extending from the installation tool proximal end to the installation tool distal end, a lumen enclosed by an inner surface of the wall and extending between the installation tool proximal end and the installation tool distal end, a handle disposed in proximity to the installation tool proximal end and extending laterally from the outer wall, a suction pad strut extending distally from the outer wall in proximity to a distal end opening of the lumen to terminate in a suction pad, and a suction lumen extending within the outer wall between the installation tool proximal end and the suction pad;

wherein the implantation tool is adapted to extend within the lumen of the installation tool such that the implantation tool distal end extends out the distal end opening of the lumen, to be disposed adjacent to the suction pad strut, and the thumbwheel is disposed proximal to a proximal end opening of the lumen and adjacent to the handle of the installation tool; and

the inner surface of the installation tool outer wall includes a threaded portion to mate with the threaded portion of the outer surface of the implantation tool, when the implantation tool extends within the lumen of the installation tool, such that rotation of the thumbwheel advances the implantation tool within the lumen.

30. The system of claim 29, wherein the suction pad extends through an arc about a longitudinal axis of the lumen.

31. The system of claim 29, wherein the suction pad strut is flexible to bend away from the longitudinal axis of the lumen when loaded by an applied force.