Lead system for providing electrical stimulation to the Bundle of His

• US 7,027,876 B2
• Filed: 09/30/2002
• Issued: 04/11/2006
• Est. Priority Date: 10/12/2001
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Casavant, David A., Hess, Douglas N.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/261,313
• Publication Number:
  US 20030083727A1
• Time in Patent Office: 1,289 Days
• Field of Search: 607/119, 607/122, 607/123, 607126-127
• US Class Current: 607/126
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

Methods and endocardial screw-in leads for enabling provision of electrical stimulation to the heart, particularly the His Bundle in the intraventricular septal wall. An endocardial screw-in lead having a distal end coupled to a retractable fixation helix wherein a distal portion of the fixation helix extends beyond the lead distal end when the fixation helix is fully retracted or partially extended is positioned in proximity to the His Bundle in the septal wall. The lead body is rotated to attach the distal portion of the fixation helix into the septal wall. The fixation helix is rotated with respect to the lead body to fully extend the fixation helix so that a portion of the fixation helix is in proximity to the His Bundle, enabling provision of electrical stimulation to the His Bundle and/or to sense electrical signals of the heart traversing the His Bundle through the fixation helix.

Claims

1. A lead for providing electrical stimulation to a His Bundle of a heart, comprising:

a lead body having a distal end;

a conductor residing within the lead body and having a distal end;

a fixation mechanism coupled to the conductor distal end, the fixation mechanism having a length selected to allow a distal end of the fixation mechanism to be proximal to the Bundle of His when the fixation mechanism is affixed to tissue surrounding the Bundle of His, wherein a distal end of the fixation mechanism extends beyond the distal end of the lead body when the fixation mechanism is fully retracted.

2. The lead system of claim 1, wherein the fixation mechanism is a fixation helix.

3. The lead system of claim 2, wherein the fixation helix is substantially between 2.5 and 7 millimeters in length.

4. The lead system of claim 2, wherein the fixation helix is substantially between 3 and 5 millimeters in length.

5. The lead of claim 3, wherein substantially the entire length of the fixation helix resides within the lead body when the fixation helix is in a fully retracted state.

6. The lead of claim 1, and further comprising:

a second conductor residing within the lead body; and

a ring electrode coupled to the second conductor.

7. An electrode system for providing electrical stimulation to a His Bundle of a heart, comprising:

a housing member;

a fixation member positioned within the housing member, the fixation member being sized to penetrate tissue of the heart to contact the His Bundle, wherein the fixation member is a fixation helix a distal end of the fixation helix extends beyond the housing member when the fixation helix is fully retracted.

8. The electrode system of claim 7, wherein the fixation helix is substantially between 2.5 and 7 millimeters in length.

9. The electrode system of claim 7, wherein the fixation helix is substantially between 3 and 5 millimeters in length.

10. The electrode system of claim 7, wherein substantially the entire length of the fixation helix resides within the housing member when the fixation helix is in a fully retracted state.

11. A method for enabling provision of electrical stimulation to a heart and sensing of heart signals via a endocardial screw-in lead having a lead body distal end supporting an extendable and retractable fixation helix operable as a stimulation and sensing electrode, the method comprising:

advancing the catheter and lead into a ventricular heart chamber;

positioning the lead body distal end in proximity to the His Bundle in the septal wall of the ventricle;

rotating the lead body to attach the distal portion of the fixation helix into the septal wall of the heart;

rotating the fixation helix with respect to the lead body to extend the fixation helix into the septal wall to dispose the fixation helix in proximity to the His Bundle to enable provision of electrical sensing and stimulation through the fixation helix to the His Bundle, further comprising the step of performing pacing and sensing threshold tests following attachment of the distal portion of the fixation helix.

12. The method of claim 11, wherein the positioning step further comprises mapping the septal wall employing the distal fixation helix to ascertain the His Bundle location.

13. A method for enabling provision of electrical stimulation to a heart via an endocardial screw-in lead having a lead body distal end supporting an extendable and retractable fixation helix operable as a sensing and stimulation electrode, a distal portion of the fixation helix extending distally beyond the lead body distal end when a proximal portion of the fixation helix is fully retracted into a chamber of the lead body, the method comprising:

inserting the lead through a catheter lumen to dispose the distal portion of the fixation helix within the catheter lumen;

advancing the catheter and lead into a ventricular heart chamber;

positioning the lead body distal end in proximity to the His Bundle in the septal wall of the ventricle;

rotating the lead body to attach the distal portion of the fixation helix into the septal wall of the heart;

rotating the fixation helix with respect to the lead body to extend the proximal portion of the fixation helix into the septal wall to dispose the fixation helix in proximity to the His Bundle to enable provision of electrical sensing and stimulation through the fixation helix to the His Bundle, further comprising the step of performing pacing and sensing threshold tests following attachment of the distal portion of the fixation helix.

14. The method of claim 13, wherein the positioning step further comprises mapping the septal wall employing the distal fixation helix to ascertain the His Bundle location.

15. A method for enabling provision of electrical stimulation to a heart and sensing of heart signals via a endocardial screw-in lead having a lead body distal end supporting an extendable and retractable fixation helix operable as a stimulation and sensing electrode, the method comprising:

advancing the catheter and lead into a ventricular heart chamber;

positioning the lead body distal end in proximity to the His Bundle in the septal wall of the ventricle;

rotating the fixation helix with respect to the lead body to extend a distal portion of the fixation helix from the lead body distal end;

rotating the lead body to attach the distal portion of the fixation helix into the septal wall of the heart;

rotating the fixation helix with respect to the lead body to extend a proximal portion of the fixation helix into the septal wall to dispose the fixation helix in proximity to the His Bundle to enable provision of electrical stimulation and sensing through the fixation helix to the His Bundle; and

performing pacing and sensing threshold tests following attachment of the distal portion of the fixation helix.

16. The method of claim 15, wherein the positioning step further comprises mapping the septal wall employing the distal fixation helix to ascertain the His Bundle location.

17. A lead for providing electrical stimulation to a His Bundle of a heart, comprising:

a lead body having a distal end;

a conductor residing within the lead body and having a distal end;

an extendable fixation mechanism coupled to the conductor distal end and extendable from a retracted position to an extended position, wherein a portion of the fixation mechanism extends distal from the lead body and rotational movement between the fixation mechanism and the lead body is precluded when the fixation mechanism is in the retracted position.

18. The lead of claim 17, wherein the fixation mechanism is a fixation helix.

19. The lead of claim 18, wherein the fixation helix is substantially between 2.5 and 7 millimeters in length.

20. The lead of claim 18, wherein the fixation helix is substantially between 3 and 5 millimeters in length.

21. The lead of claim 17, and further comprising:

a second conductor residing within the lead body; and

a ring electrode coupled to the second conductor.

22. An electrode system for providing electrical stimulation to a His Bundle of a heart, comprising:

a housing member;

an extendable fixation member positioned within the housing member and moveable from a retracted position wherein the fixation member is locked with respect to the housing and an extended position wherein the fixation member is rotationally moveable relative to the housing, wherein a portion of the fixation member is exposed distally from the housing member when the fixation member is in the retracted position.