Electrical stimulation leads and systems with folding anchoring units and methods of making and using

• US 9,669,210 B2
• Filed: 04/17/2015
• Issued: 06/06/2017
• Est. Priority Date: 04/22/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John M., Leven, Jacob B., Wechter, David Ernest
• Primary Examiner(s): WEHRHEIM, LINDSEY GAIL
• Application Number:
  US14/690,071
• Publication Number:
  US 20150297882A1
• Time in Patent Office: 781 Days
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• 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 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

An electrical stimulation lead includes at least one anchoring unit and each anchoring unit includes a lead attachment element. Some anchoring units include one or more anchoring fins attached to the lead attachment element and extending away from the lead attachment element when in a deployed position for contact with patient tissue to anchor the lead within the patient tissue. Each anchoring fin also has a retracted position in which the anchoring fin folds down and lies next to the lead attachment element. Other anchoring units include one or more anchoring tabs defined by the lead attachment element. Each anchoring tab is partially separated from a remainder of the lead attachment element by at least one cutout and extends away from the remainder of the lead attachment element when in a deployed position for contact with patient tissue to anchor the lead within the patient tissue.

Claims

1. An electrical stimulation lead, comprising:

a non-conductive lead body having an outer surface, 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 extending through the lead body, each conductor of the plurality of conductors electrically coupling each of the plurality of terminals to at least one of the plurality of electrodes; and

at least one anchoring unit disposed around the outer surface of a portion of the lead body, each of the at least one anchoring unit having a first end and a second end and comprising

a lead attachment element having a longitudinal length and a central lumen within which a portion of the lead body is received, and

a plurality of anchoring fins, wherein each anchoring fin is attached to the lead attachment element and each anchoring fin extends away from the lead attachment element when in a deployed position and is configured and arranged for contact with patient tissue to anchor the lead within the patient tissue, wherein each anchoring fin is configured and arranged to have a retracted position in which the anchoring fin folds down and lies next to the lead attachment element and does not overlap with any other of the plurality of anchoring fins in the retracted position, wherein each of the anchoring fins is attached to the lead attachment element along at least 90% of the longitudinal length of the lead attachment element.

2. The electrical stimulation lead of claim 1, wherein each anchoring fin increases in size from the first end to the second end of the at least one anchoring unit to which it is attached or each anchoring fin has a curled distal end.

3. The electrical stimulation lead of claim 1, wherein each anchoring fin has a first side and wherein, in the deployed position, the first side of at least one of the anchoring tins forms an angle with the lead attachment element of less than 90 degrees so that the anchoring fin preferentially folds down with the first side next to the lead attachment element.

4. The electrical stimulation lead of claim 1, wherein the central lumen of the lead attachment element defines a central axis and wherein at least one of the anchoring fins has a first end and a second end and extends from the first end to the second end of the anchoring fin along a line of attachment between the anchoring fin and the lead attachment element that is not parallel to the central axis of the central lumen.

5. The electrical stimulation lead of claim 1, wherein at least one of the anchoring fins has a first end and a second end and extends along a line of attachment between the anchoring fin and the lead attachment element from the first end to the second end of the anchoring fin along a non-linear curve.

6. The electrical stimulation lead of claim 1, wherein each of the anchoring fins is coupled in a curved attachment line between the anchoring fin and the lead attachment element.

7. The electrical stimulation lead of claim 1, wherein at least one of the anchoring fins comprises an opening through the anchoring fin to allow tissue in-growth through the opening.

8. The electrical stimulation lead of claim 1, wherein the at least one anchoring unit is a plurality of anchoring units and wherein either the anchoring fins of adjacent anchoring units are rotationally staggered or an outer diameter of the anchoring fins decreases between adjacent anchoring units.

9. An electrical stimulation 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.

10. An electrical stimulation lead, comprising:

a non-conductive lead body having an outer surface, 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 extending through the lead body, each conductor of the plurality of conductors electrically coupling each of the plurality of terminals to at least one of the plurality of electrodes; and

at least one anchoring unit disposed around the outer surface of a portion of the lead body, each of the at least one anchoring unit having a first end and a second end and comprising

a lead attachment element defining at least one anchoring tab and a central lumen within which the portion of the lead body is received, wherein each anchoring tab is partially separated from a remainder of the lead attachment element by at least one cutout, wherein each anchoring tab extends away from the remainder of the lead attachment element when in a deployed position and is configured and arranged for contact with patient tissue to anchor the lead within the patient tissue, wherein each anchoring tab is configured and arranged to have a retracted position in which the at least one anchoring tab form a cylindrical arrangement with the remainder of the lead attachment element.

11. The electrical stimulation lead of claim 10, wherein at least one of the at least one anchoring tab has an isosceles trapezoidal shape in the deployed position.

12. The electrical stimulation lead of claim 10, wherein at least one of the at least one anchoring tab has a right trapezoidal shape in the deployed position.

13. The electrical stimulation lead of claim 10, wherein the at least one anchoring tab comprises a first anchoring tab and a second anchoring tab opposite the first anchoring tab when both the first and second anchoring tabs are in the deployed position.

14. The electrical stimulation lead of claim 10, wherein the at least one anchoring tab is configured and arranged to deploy when heated within a body of a patient upon implantation.

15. The electrical stimulation lead of claim 10, wherein, in the deployed position, the at least one anchoring tab extends at an angle of at least 30 degrees with respect to the remainder of the lead attachment element.

16. The electrical stimulation lead of claim 10, Wherein the at least one anchoring tab is configured and arranged to deploy when the lead is rotated within a body of a patient after implantation.

17. The electrical stimulation lead of claim 10, wherein at least one of the at least one anchoring tab comprises an opening through the anchoring tab to allow tissue in-growth through the opening.

18. An electrical stimulation system, comprising:

the electrical stimulation lead of claim 10;

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 on the proximal end portion of the lead body of the electrical stimulation lead.