Electrical stimulation leads with multiple anchoring units and methods of making and using

• US 9,364,658 B2
• Filed: 02/27/2015
• Issued: 06/14/2016
• Est. Priority Date: 03/03/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Wechter, David Ernest
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/634,253
• Publication Number:
  US 20150246217A1
• Time in Patent Office: 473 Days
• Field of Search: 607/119
• US Class Current: 1/1
• 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 1/0558 Anchoring or fixation means therefor

Abstract

An electrical stimulation lead includes a lead body; electrodes disposed along a distal end portion of the lead body; terminals disposed along a proximal end portion of the lead body; conductors electrically coupling the terminals to the electrodes; and anchoring units disposed along the distal end portion of the lead body. First and second anchoring units each have a wide end portion and a narrow end portion. The first anchoring unit is disposed closer to the proximal end portion of the lead body than any of the other anchoring units. The wide end portion of the first anchoring unit is disposed closer to the proximal end portion of the lead body than the narrow end portion. The narrow end portion of the second anchoring unit is disposed closer to the proximal end portion of the lead body than the wide end portion.

Claims

1. An electrical stimulation lead, comprising:

a lead body having a distal end portion, a proximal end portion, and a longitudinal length;

a plurality of electrodes disposed along the distal end portion of the lead body;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of conductors electrically coupling the terminals to the electrodes; and

a plurality of anchoring units disposed along the distal end portion of the lead body, the plurality of anchoring units comprising a first anchoring unit and a second anchoring unit, wherein the first and second anchoring units each comprise a wide end portion and a narrow end portion, wherein a largest outer radius of the wide end portion is larger than a largest outer radius of the narrow end portion,

wherein the first anchoring unit is disposed closer to the proximal end portion of the lead body than any other of the plurality of anchoring units, wherein the wide end portion of the first anchoring unit is disposed closer to the proximal end portion of the lead body than the narrow end portion of the first anchoring unit and the narrow end portion of the second anchoring unit is disposed closer to the proximal end portion of the lead body than the wide end portion of the second anchoring unit, and wherein at least one of the electrodes is disposed distal to all of the anchoring units.

2. The electrical stimulation lead of claim 1, wherein the plurality of anchoring units further comprises a third anchoring unit disposed adjacent the first anchoring unit, wherein the third anchoring unit comprises a wide end portion and a narrow end portion, wherein a largest outer radius of the wide end portion is larger than a largest outer radius of the narrow end portion, wherein the narrow end portion of the third anchoring unit is disposed closer to the proximal end portion of the lead body than the wide end portion of the third anchoring unit.

3. The electrical stimulation lead of claim 1, wherein the plurality of anchoring units further comprises a fourth anchoring unit disposed adjacent, and distal to, the second anchoring unit, wherein the fourth anchoring unit comprises a wide end portion and a narrow end portion, wherein a largest outer radius of the wide end portion is larger than a largest outer radius of the narrow end portion, wherein the wide end portion of the fourth anchoring unit is disposed closer to the proximal end portion of the lead body than the narrow end portion of the fourth anchoring unit.

4. The electrical stimulation lead of claim 3, wherein the plurality of anchoring units further comprises a fifth anchoring unit disposed adjacent, and proximal to, the second anchoring unit, wherein the fifth anchoring unit comprises a wide end portion and a narrow end portion, wherein a largest outer radius of the wide end portion is larger than a largest outer radius of the narrow end portion, wherein the wide end portion of the fifth anchoring unit is disposed closer to the proximal end portion of the lead body than the narrow end portion of the fifth anchoring unit.

6. The electrical stimulation lead of claim 1, wherein at least one of the electrodes is disposed between the first anchoring unit and the second anchoring unit.

7. The electrical stimulation lead of claim 1, where each of the plurality of anchoring units comprises a lead attachment element and a plurality of fins, each fin attached to, and extending away from, the lead attachment element.

8. An electrical stimulating system comprising:

the electrical stimulation lead of claim 1;

a control module coupleable to the electrical stimulation lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the electrical stimulation lead, the connector having a proximal end a distal end, and a longitudinal length, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end portion of the lead body of the electrical stimulation lead, and

a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed along the proximal end portion of the lead body of the electrical stimulation lead.

9. The electrical stimulation lead of claim 1, wherein

at least one of the anchoring units forms a wide end arrangement, the wide end arrangement comprising a distal end portion, a proximal end portion, and a middle portion,

wherein the proximal end portion and distal end portion of the wide end arrangement each have a largest outer radius that is larger than a largest outer radius of the middle portion of the wide end arrangement.

10. The electrical stimulation lead of claim 9, wherein at least one of the anchoring units forms a wide center arrangement, the wide center arrangement comprising a distal end portion, a proximal end portion, and a middle portion, wherein the proximal end portion and distal end portion of the wide center arrangement each have a largest outer radius that is smaller than a largest outer radius of the middle portion of the wide center arrangement.

11. The electrical stimulation lead of claim 9, wherein at least one of the anchoring units forms a combination arrangement, the combination arrangement comprising a distal end portion, a proximal end portion, a wide middle portion, and a narrow middle portion, wherein the proximal end portion and the wide middle portion of the combination arrangement each have a largest outer radius that is larger than a largest outer radius of each of the distal end portion and the narrow middle portion of the combination arrangement, wherein the narrow middle portion is positioned between the proximal end portion and the wide middle portion and the wide middle portion is positioned between the distal end portion and the narrow middle portion.

12. The electrical stimulation lead of claim 9, wherein the wide end arrangement is formed by two of the anchoring units.

13. The electrical stimulation lead of claim 9, where each of the plurality of anchoring units comprises a lead attachment element and a plurality of fins, each fin attached to, and extending away from, the lead attachment element.

5. An electrical stimulation lead, comprising:

a lead body having a distal end portion, a proximal end portion, and a longitudinal length;

a plurality of electrodes disposed along the distal end portion of the lead body;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of conductors electrically coupling the terminals to the electrodes; and

a plurality of anchoring units disposed along the distal end portion of the lead body, the plurality of anchoring units comprising a first anchoring unit and a second anchoring unit, wherein the first and second anchoring units each comprise a wide end portion and a narrow end portion, wherein a largest outer radius of the wide end portion is larger than a largest outer radius of the narrow end portion,

wherein the first anchoring unit is disposed closer to the proximal end portion of the lead body than any other of the plurality of anchoring units, wherein the wide end portion of the first anchoring unit is disposed closer to the proximal end portion of the lead body than the narrow end portion of the first anchoring unit and the narrow end portion of the second anchoring unit is disposed closer to the proximal end portion of the lead body than the wide end portion of the second anchoring unit, and

wherein at least one of the electrodes is disposed proximal to all of the anchoring units.

14. An electrical stimulation lead, comprising:

a lead body having a distal end portion, a proximal end portion, and a longitudinal length;

a plurality of electrodes disposed along the distal end portion of the lead body;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of conductors electrically coupling the terminals to the electrodes; and

a plurality of anchoring units disposed along the distal end portion of the lead body, each of the anchoring units comprising a lead attachment element and a plurality of fins, each fin attached to, and extending away from, the lead attachment element, the plurality of anchoring units comprising a first anchoring unit and a second anchoring unit, wherein the first and second anchoring units each comprise a wide portion where the fins extend furthest from the lead attachment element and a narrow portion where the fins extend least from the lead attachment element,

wherein the first anchoring unit is disposed closer to the proximal end portion of the lead body than any other of the plurality of anchoring units, wherein the wide portion of the first anchoring unit is disposed closer to the proximal end portion of the lead body than the narrow portion of the first anchoring unit and the narrow portion of the second anchoring unit is disposed closer to the proximal end portion of the lead body than the wide portion of the second anchoring unit, and wherein at least one of the electrodes is disposed distal to all of the anchoring units.

15. The electrical stimulation lead of claim 14, wherein the plurality of anchoring units further comprises a third anchoring unit disposed adjacent the first anchoring unit, wherein the third anchoring unit comprises a wide portion where the fins extend furthest from the lead attachment element and a narrow portion where the fins extend least from the lead attachment element, wherein the narrow portion of the third anchoring unit is disposed closer to the proximal end portion of the lead body than the wide portion of the third anchoring unit.

16. The electrical stimulation lead of claim 15, wherein the first and third anchoring units form a wide end arrangement comprising a distal end portion, a proximal end portion, and a middle portion, wherein the proximal end portion and distal end portion of the wide end arrangement each have a largest outer radius that is larger than a largest outer radius of the middle portion of the wide end arrangement.

17. The electrical stimulation lead of claim 14, wherein the plurality of anchoring units further comprises a fourth anchoring unit disposed adjacent, and distal to, the second anchoring unit, wherein the fourth anchoring unit comprises a wide portion where the fins extend furthest from the lead attachment element and a narrow portion where the fins extend least from the lead attachment element, wherein the wide portion of the fourth anchoring unit is disposed closer to the proximal end portion of the lead body than the narrow end portion of the fourth anchoring unit.

18. The electrical stimulation lead of claim 17, wherein the second and fourth anchoring units form a wide center arrangement comprising a distal end portion, a proximal end portion, and a middle portion, wherein the proximal end portion and distal end portion of the wide end arrangement each have a largest outer radius that is smaller than a largest outer radius of the middle portion of the wide end arrangement.

19. The electrical stimulation lead of claim 17, wherein the plurality of anchoring units further comprises a fifth anchoring unit disposed adjacent, and proximal to, the second anchoring unit, wherein the fifth anchoring unit comprises a wide portion where the fins extend furthest from the lead attachment element and a narrow portion where the fins extend least from the lead attachment element, wherein the wide portion of the fifth anchoring unit is disposed closer to the proximal end portion of the lead body than the narrow end portion of the fifth anchoring unit.

20. The electrical stimulation lead of claim 19, wherein the second, fourth, and fifth anchoring units form a combination arrangement comprising a distal end portion, a proximal end portion, a wide middle portion, and a narrow middle portion, wherein the proximal end portion and the wide middle portion of the combination arrangement each have a largest outer radius that is larger than a largest outer radius of each of the distal end portion and the narrow middle portion of the combination arrangement, wherein the narrow middle portion is between the proximal end portion and the wide middle portion and the wide middle portion is between the distal end portion and the narrow middle portion.