Rotatable lead introducer

• US 20050004644A1
• Filed: 05/06/2004
• Published: 01/06/2005
• Est. Priority Date: 05/06/2003
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Enpath Medical, Inc. (Integer Holdings Corporation Inc)
• Inventors: Rundle, Kenneth P., Anderson, Kent D., Fell, Roger B., Erickson, Dave S., Kelsch, Daniel N., Jahns, Scott E., Mellor, James L., Fischer, Vincent A. III
• Granted Patent: US 7,544,197 B2
• Time in Patent Office: Days
• US Class Current: 607/131
• CPC Class Codes: A61B 17/8888 at its central region
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/2929 with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/2937 with flexible part
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: B25B 27/143 for installing wire thread inserts or tubular threaded inserts

Abstract

Minimally invasive introducers and methods that can be used for rotationally securing devices within the human body. Introducers can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.

Claims

1. A device for rotating and inserting an epicardial-myocardial cardiac lead including a helical electrode, an electrode head, and a lead body, the device comprising:

an elongate shaft having a proximal portion and a distal portion;

a first distal member pivotally coupled to the elongate shaft distal portion;

a second distal member rotatably coupled to the first distal member;

wherein the second distal member includes a portion for releasably engaging the lead head;

a rotatable tube having a proximal portion and a distal portion, the tube disposed around the elongate shaft and rotatably flexibly coupled over the first distal member pivotal coupling to the second distal member;

a first elongate member having a distal region operably coupled to the head releasable engagement member and having a proximal portion actuable from the device proximal portion to release the lead head;

a second elongate member having a distal region operably coupled to the first or second distal member for causing the first distal member to pivot relative to the elongate shaft, and having a proximal portion acuatable from the device proximal portion.

2. The device as in claim 1, wherein the elongate shaft is a tube having the first and second elongate members disposed within.

3. The device as in claim 2, wherein the first and second elongate members are slidably disposed within the elongate shaft.

4. The device as in claim 1, wherein the second elongate member operable coupling to the first or second distal member forms a lever arm with respect to the pivotal coupling of the elongate shaft to the first distal member.

5. The device as in claim 4, wherein the second elongate member actuates in both compression and in tension.

6. The device as in claim 1, in which the release engagement portion is reversibly transversely moveable relative to a central longitudinal axis of the engagement portion, wherein the first elongate member operable coupling is coupled to urge the releasable engagement portion transversely outward to release the lead head.

7. The device as in claim 6, in which the second distal member includes a collet having jaws, in which the first elongate member is operably coupled to an element for urging the jaws apart when the first elongate member is proximally retracted.

8. The device as in claim 7, wherein the first elongate member operably coupling releases a camming force on the jaws, allowing the jaws to open when the first elongate member is proximally retracted.

9. The device as in claim 1, wherein the first elongate member acts only in tension.

10. The device as in claim 1, wherein the second elongate member is operably coupled to the second distal member.

11. The device as in claim 1, further comprising a manually operable rotatable portion coupled to the outer tube, wherein the manually rotatable portion has a larger radius then the tube and is coupled to effect rotation of the tube.

12. The device as in claim 1, wherein the first elongate member proximal portion is actuatable through a slider element.

13. The device as in claim 1, further comprising at least one guide along the outer tube external surface to secure the lead body to the outer tube.

14. The device as in claim 13, in which the guide allows for axial movement of the lead body within the guide.

15. The device as in claim 1, in which the first distal member is a distal portion of a hinge and in which the second distal member includes a collet rotatably disposed about the hinge distal portion.

16. The device as in claim 1, in which the second distal member includes a collet and in which the collet includes jaws that can be urged apart through a camming action actuated from the device proximal portion using the first elongate member.

17. The device as in claim 16, in which the collet includes a plurality of inwardly protruding teeth.

18. A method for inserting an epicardial-myocardial cardiac lead having a lead head, a helical electrode, and a lead body, the method comprising:

advancing the lead head and lead body through a port or small incision into a human body, having the lead helical electrode oriented substantially in the direction of travel through the port or small incision;

bending the lead head to present the helical electrode substantially perpendicular to the epicardial surface; and

rotating the lead head to advance the helical electrode into the epicardium and myocardium.

19. The method as in claim 18, further comprising releasably engaging the lead head to the distal region of an elongate instrument prior to the advancing, and releasing the lead head from the elongate instrument distal region after the rotating.

20. The method as in claim 18, further comprising releasably securing the lead body to an elongate instrument outer tube such that the lead body rotates with the outer tube.

21. The method as in claim 19, in which the releasably engaging includes inserting the lead head into a lead gripping member biased to grip the lead head with at least three gripping members.

22. A device for rotating and inserting an epicardial-myocardial cardiac lead including a helical electrode, an electrode head, and a lead body, the device comprising:

an elongate shaft having a proximal portion and a distal portion;

a rotatable tube disposed over the elongate shaft and having a distal portion; and

a distal member pivotally coupled to the elongate shaft distal portion and rotatably coupled to the rotatable tube;

wherein the distal member is configured for releasably engaging the lead head.

23. The device of claim 22, in which the distal member for releasably engaging the lead head is controlled from the shaft proximal portion.

24. The device of claim 22, in which the shaft is a rotatable tube.

25. The device of claim 22, in which the rotatable coupling between the rotatable tube and the distal member includes a flexible outer coupling.

26. A method for determining placement of an epicardial-myocardial pacing lead in a heart, the pacing lead including a lead head having a head diameter, the method comprising:

placing a mapping lead head in a lead introducer distal portion, the mapping lead head having a head diameter about the same size as the pacing lead head diameter, the mapping lead having an electrode not configured to remain securely attached to the heart;

advancing the lead introducer carrying the mapping lead head through an incision or port in the patient;

bringing the mapping lead electrode to bear against the heart and measuring at least one electrical property; and

determining a location for placement of the pacing at least in part on the electrical property measured.

27. The method as in claim 26, in which the measuring includes measuring impedance.

28. The method as in claim 26, in which the measuring includes determining a location on the left ventricle that has the latest activation.

29. The method as in claim 26, in which the mapping electrode has the electrode dull and not capable in penetrating the heart.

30. The method of claim 26, in which the mapping electrode has the electrode as a substantially straight needle.

31. A method for attaching an epicardial-myocardial lead helical electrode to the heart of a patient, the method comprising:

securing the electrode head to the distal end of a lead introducer having an outer tube;

advancing the lead introducer through an incision in the patient;

bringing the lead electrode to bear against the heart; and

rotating the lead introducer distal end to screw the lead helical end into the heart while rotating the outer tube and lead body and maintaining the position of the lead relative to the outer tube.

32. The method of claim 31, further comprising bending the distal end of the lead introducer while the lead introducer is within the patient.

33. A device for rotating and inserting an epicardial-myocardial cardiac lead including a helical electrode, an electrode head, and a lead body, the device having a proximal portion and a distal portion, the device comprising:

means for releasably engaging the electrode head disposed in the device distal portion;

means for controlling the releasable engaging means from the device proximal portion;

means for controllably bending the device distal portion;

means for controlling the controllable bending means from the device distal portion;

means for controllably rotating the releasable engaging means; and

means for controlling the controllable rotating means from the device proximal portion.

34. The device for rotating and inserting an epicardial-myocardial cardiac lead as in claim 33, wherein the means for controllably rotating includes means for limiting torque applied to the electrode head.

35. The device for rotating and inserting an epicardial-myocardial cardiac lead as in claim 33, wherein the device further includes a mapping lead including a lead body, a lead head, and a lead electrode, wherein the mapping lead electrode has either a dull shape or a straight needle shape, for reversibly contacting at least the epicardial surface.

36. The device for rotating and inserting an epicardial-myocardial cardiac lead as in claim 35, wherein the device further includes an impedance measuring circuit for measuring the impedance between two electrodes contacting the heart.

37. A device for rotating and inserting an epicardial-myocardial cardiac lead including a helical electrode, an electrode head, and a lead body, the device having a proximal portion and a distal portion, the device comprising:

an elongate shaft having a proximal portion and a distal portion;

a hinge having a proximal portion coupled to the elongate shaft distal portion, and a distal portion;

a lead grasping member rotatably coupled to the hinge distal portion;

wherein the lead grasping member includes jaws configured and dimensioned to releasably grasp an epicedial-myocardial pacing lead, and an internal camming surface coupled to the jaws;

a camming element disposed within the lead grasping member and biased to apply force to the camming surface to open the jaws;

a first elongate member having a distal region coupled to the camming element to reduce the bias when the first elongate member is proximally retracted, and a proximal portion actuatable from the device proximal portion;

a second elongate element having a distal region operably coupled to the hinge distal portion and a proximal region actuatable from the device proximal portion; and

a tube rotatably disposed over the elongate shaft and rotatably coupled to the lead grasping member over the hinge.

38. The device of claim 37, in which the lead grasping member includes a collet having teeth disposed to be located about the lead head and having an inter-tooth spacing of no greater than about 100 degrees.

39. The device of claim 37, having at least one lead body guide for holding the lead body along the rotatable tube while the tube is rotating.