Medical lead designs for lead placement through tissue

• US 20040215307A1
• Filed: 04/23/2003
• Published: 10/28/2004
• Est. Priority Date: 11/29/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lokhoff, Nicolaas M., Michels, Koen
• Granted Patent: US 7,546,166 B2
• Time in Patent Office: Days
• US Class Current: 607/126
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

The invention is directed to medical lead designs that facilitate implantation of the leads through tissue. For example, the leads can implanted though tissue for placement of distal tips of the leads in locations on the opposing side of the tissue. The leads include fixation elements, such as flexible tines, that facilitate fixation to the tissue. The fixation elements can protrude from lead at a location more than 5 millimeters from the distal-tip of the lead such that when the distal tip has passed through the tissue, the fixation elements anchor in the tissue.

Claims

1. A medical lead comprising:

a lead body that extends from a proximal end to a distal end; and

a tissue fixation element protruding from the lead body at a location at least five millimeters from the distal end.

2. The medical lead of claim 1, wherein the fixation element protrudes from the lead body at a location between 5 and 35 millimeters the distal end.

3. The medical lead of claim 2, wherein the fixation element protrudes from the lead body at a location between 10 and 20 millimeters the distal end.

4. The medical lead of claim 1, wherein a distal region of the lead forms a J-shape.

5. The medical lead of claim 4, wherein the J-shape spans a distal most 15-25 millimeters of the lead body.

6. The medical lead of claim 1, wherein the tissue fixation element comprises a flexible tine.

7. The medical lead of claim 6, wherein the tine is hollow.

8. The medical lead of claim 6, further comprising a plurality of flexible tines protruding from the lead body at the location at least five millimeters from the distal end.

9. The medical lead of claim 1, wherein the lead body is formed with a lumen to permit passage of a stylet.

10. The medical lead of claim 1, further comprising an electrode disposed at the distal end and an electrical contact element in proximity to the proximal end and electrically coupled to the electrode via one or more conductive elements that extend along the lead body.

11. A system comprising:

an implantable medical device; and

an implantable lead including;

a lead body that extends from a proximal end to a distal end, the proximal end being coupled to the implantable medical device; and

a tissue fixation element protruding from the lead body at a location at least five millimeters from the distal end.

12. The system of claim 11, wherein the fixation element protrudes from the lead body at a location between 10 and 20 millimeters the distal end.

13. The system of claim 11, wherein a distal region of the lead forms a J-shape that spans a distal most 15-25 millimeters of the lead body.

14. The system of claim 11, wherein the tissue fixation element comprises a flexible tine.

15. The system of claim 14, wherein the tine is hollow.

16. The system of claim 14, the medical lead further including a plurality of flexible tines protruding from the lead body at the location at least five millimeters from the distal end.

17. The system of claim 11, the medical lead further comprising an electrode disposed at the distal end and an electrical contact element in proximity to the proximal end, the electrical contact element being electrically coupled to the implantable medical device and electrically coupled to the electrode via one or more conductive elements that extend along the lead body.

18. A system comprising:

a catheter defining a proximal end and a distal end of the catheter and including fixation structures on the distal end of the catheter for fixation to tissue;

a medical lead for insertion through the catheter and including a lead body defining a lumen that extends from a proximal end to a distal end of the medical lead, and a tissue fixation element protruding from the lead body at a location at least five millimeters from the distal end of the medical lead; and

a stylet for insertion through the lumen of the lead body, wherein a distal end of the stylet defines a piercing element for piercing tissue.

19. The system of claim 18, wherein the fixation element protrudes from the lead body at a location between 10 and 20 millimeters the distal end of the lead body.

20. The system of claim 18, wherein a distal region of the lead body forms a J-shape that spans a distal most 15-25 millimeters of the lead body.

21. The system of claim 18, wherein the tissue fixation element of the medical lead comprises a flexible tine.

22. The system of claim 21, wherein the tine is hollow.

23. The system of claim 21, the medical lead further including a plurality of flexible tines protruding from the lead body at the location at least five millimeters from the distal end of the lead body.

24. The system of claim 18, the medical lead further comprising an electrode disposed at the distal end of the lead body and an electrical contact element in proximity to the proximal end of the lead body and electrically coupled to the electrode via one or more conductive elements that extend along the lead body.

25. A method comprising:

attaching a distal end of a catheter to a right ventricular wall of a patient;

inserting a stylet through a lumen of a medical lead to straighten a J-shaped distal region of the medical lead, the medical lead including a tissue fixation element protruding from the medical lead at a location at least five millimeters from a distal end of the medical lead;

inserting the stylet and medical lead through the catheter;

piercing an inter-ventricular septum with a distal end of the stylet; and

inserting the distal end of the medical lead into a left ventricle of the patient through the inter-ventricular septum such that the tissue fixation element is positioned in the inter-ventricular septum.

26. The method of claim 25, further comprising removing the stylet from the lumen to cause the distal region of the medical lead to re-assume the J-shape such that an electrode on the distal end of the medical lead contacts a left ventricular wall of the patient.

27. The medical lead of claim 26, further comprising:

removing the catheter; and

attaching a proximal end of the medical lead to an implantable medical device.

28. The method of claim 25, wherein the fixation element protrudes from the medical lead at a location between 10 and 20 millimeters the distal end of the medical lead.

29. The method of claim 25, wherein the tissue fixation element of the medical lead comprises a flexible tine.

30. The method of claim 29, wherein the medical lead further includes a plurality of flexible tines protruding from the medical lead at the location at least five millimeters from the distal end of the medical lead.