Helical fixation elements for subcutaneous electrodes

• US 20040230280A1
• Filed: 12/18/2003
• Published: 11/18/2004
• Est. Priority Date: 04/11/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Shiroff, Jason Alan, Cates, Adam W., Heil, Ron, Lindstrom, Curtis Charles, Kelley, Pete
• Granted Patent: US 7,499,758 B2
• Time in Patent Office: Days
• US Class Current: 607/126
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Subcutaneous leads that incorporate active fixation elements including, for example, helical coils, provide for fixation of cardiac lead components within a patient. An implantable lead includes a lead body with a supported electrode configured for subcutaneous non-intrathoracic placement within a patient. A fixation element is provided on the implantable lead and configured to actively secure one or both of the subcutaneous electrode and the lead body in tissue. A delivery apparatus comprising a sheath may be employed that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location. Lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead supporting an electrode, advancing the lead through the sheath, actively fixing the lead to tissue, and thereafter removing the sheath from the patient.

Claims

1. An implantable lead, comprising:

a lead body having a body cross-sectional diameter;

a cardiac electrode supported by the lead body, the cardiac electrode configured for subcutaneous non-intrathoracic placement within a patient; and

a fixation element provided on the implantable lead, the fixation element configured to actively secure the lead in subcutaneous non-intrathoracic tissue.

2. The lead according to claim 1, wherein the fixation element has a fixation element cross-sectional diameter, and wherein the fixation element cross-sectional diameter is larger than the body cross-sectional diameter of the lead body.

3. The lead according to claim 2, wherein the fixation element comprises a helical coil.

4. The lead according to claim 3, wherein the helical coil is configured to be compressible while in a non-deployed configuration, a cross-sectional diameter of the helical coil substantially equal to or less than a body cross-sectional diameter while in the non-deployed configuration.

5. The lead according to claim 1, wherein the lead body has a lead longitudinal axis and the fixation element has a fixation element longitudinal axis, and wherein the lead longitudinal axis is non-coincident with respect to the fixation element longitudinal axis.

6. The lead according to claim 5, wherein the fixation element comprises a helical coil.

7. The lead according to claim 1, wherein the fixation element is formed from a material having a spring memory.

8. The lead according to claim 1, wherein the fixation element is electrically insulated from the electrode.

9. The lead according to claim 1, wherein the fixation element is part of the electrode.

10. The lead according to claim 1, wherein:

the lead body comprises a longitudinal axis; and

the fixation element comprises a longitudinal axis aligned in a non-coaxial parallel relationship with respect to the longitudinal axis of the lead body.

11. The lead according to claim 1, wherein:

the lead body comprises a longitudinal axis; and

the fixation element comprises a longitudinal axis aligned substantially perpendicular to the longitudinal axis of the lead body.

12. An implantable lead system, comprising:

a lead body having a body cross-sectional diameter;

a cardiac electrode supported by the lead body, the cardiac electrode configured for subcutaneous non-intrathoracic placement within a patient;

a fixation element provided on the implantable lead, the fixation element configured to actively secure the lead body or electrode in subcutaneous non-intrathoracic tissue; and

a delivery apparatus comprising a sheath configured to introduce the lead to a desired subcutaneous non-intrathoracic location within the patient.

13. The lead system according to claim 12, wherein the lead body has a lead longitudinal axis and the fixation element has a fixation element longitudinal axis, and wherein the lead longitudinal axis is non-coincident with the fixation element longitudinal axis.

14. The lead system according to claim 13, wherein the fixation element comprises a helical coil.

15. The lead according to claim 12, wherein:

the lead body comprises a longitudinal axis; and

the fixation element comprises a longitudinal axis aligned substantially perpendicular to the longitudinal axis of the lead body.

16. The lead system according to claim 12, wherein the fixation element has a fixation element cross-sectional diameter, and wherein the fixation element cross-sectional diameter is larger than the body cross-sectional diameter of the lead body.

17. The lead system according to claim 16, wherein the fixation element comprises a helical coil.

18. The lead system according to claim 12, wherein the fixation element is formed from a material having a spring memory.

19. The lead system according to claim 12, wherein the fixation element is electrically insulated from the electrode.

20. The lead system according to claim 12, wherein the fixation element is part of the electrode.

21. The lead system according to claim 12, wherein a lumen of the sheath is dimensioned to compress the fixation element while permitting axial displacement of the lead within the lumen.

22. A method of lead stabilization, comprising:

providing a lead comprising a lead body, a cardiac electrode configured for subcutaneous non-intrathoracic placement within a patient, and a fixation element; and

actively securing the lead to subcutaneous non-intrathoracic tissue at a fixation site using the fixation element.

23. The method according to claim 22, wherein actively securing the lead comprises acutely securing the lead to the subcutaneous non-intrathoracic tissue at

24. The method according to claim 22, wherein actively securing the lead comprises:

modifying, during lead delivery, a position or an orientation of the fixation element to facilitate axial displacement of the lead in a distal direction into the subcutaneous non-intrathoracic tissue; and

after lead delivery, rotating at least a portion of the lead about its longitudinal axis thereby fixing the fixation element in the subcutaneous non-intrathoracic tissue.

25. The method according to claim 22, wherein actively securing the lead comprises:

modifying, during lead delivery, a position or an orientation of the fixation element to facilitate axial displacement of the lead in a distal direction into the subcutaneous non-intrathoracic tissue; and

after lead delivery, rotating at least a portion of the fixation element thereby fixing the fixation element in the subcutaneous non-intrathoracic tissue.

26. The method according to claim 22, wherein actively securing the lead comprises:

modifying, during lead delivery, a position or an orientation of the fixation element to facilitate axial displacement of the lead in a distal direction into the subcutaneous non-intrathoracic tissue; and

after lead delivery, using the fixation elements to resist axial displacement of the lead.

27. The method according to claim 22, further comprising:

providing a removable sheath having a lumen; and

modifying a position or an orientation of the fixation element when the lead is advanced within the lumen.

28. The method according to claim 27, wherein modifying the position or orientation comprises compressing the fixation element when the lead is advanced within the lumen.

29. The method according to claim 27, wherein modifying the position or orientation comprises resiliently displacing the fixation element when the lead is advanced within the lumen.

30. The method according to claim 27, further comprising returning the fixation element to an initial position or orientation when the fixation element is advanced beyond, or retracted from, the lumen of the sheath.

31. An implantable lead, comprising:

a lead body;

a cardiac electrode supported by the lead body, the cardiac electrode configured for subcutaneous non-intrathoracic placement in a patient; and

means for actively fixing the lead body within subcutaneous non-intrathoracic tissue.

32. The lead according to claim 31, wherein the active fixing means comprises means for rotatably fixing one or both of the lead body and the cardiac electrode within the subcutaneous non-intrathoracic tissue.

33. The lead according to claim 31, further comprising means for modifying a position or an orientation of the fixing means.

34. The lead according to claim 31, further comprising means for delivering the lead within the patient, wherein a lumen of the delivery means is dimensioned to at least partially collapse the fixing means while permitting axial displacement of the lead body within the lumen.

35. A method of lead delivery, comprising:

introducing a sheath into a subcutaneous non-intrathoracic body location of a patient;

providing a lead comprising a lead body, a cardiac electrode configured for subcutaneous non-intrathoracic placement in a patient, and a fixation element;

advancing the lead through the sheath and to the subcutaneous non-intrathoracic body location;

actively fixing the lead to subcutaneous non-intrathoracic tissue using the fixation element; and

removing the sheath from the patient.

36. The method according to claim 35, wherein removing the sheath comprises longitudinally splitting the sheath when retracting the sheath from the patient.

37. The method according to claim 35, wherein removing the sheath comprises enabling a fixation element for active engagement with the subcutaneous non-intrathoracic tissue.

38. The method according to claim 35, wherein advancing the lead through the sheath comprises modifying a position or an orientation of the fixation element provided on the lead.

39. The method according to claim 35, wherein actively fixing the lead comprises rotating at least a portion of the lead about a longitudinal axis of the lead to fix the fixation element in the subcutaneous non-intrathoracic tissue.

40. The method according to claim 35, wherein actively fixing the lead comprises rotating at least a portion of the fixation element thereby fixing the fixation element in the subcutaneous non-intrathoracic tissue.