Anchoring units for implantable electrical stimulation systems and methods of making and using

• US 9,610,435 B2
• Filed: 05/22/2015
• Issued: 04/04/2017
• Est. Priority Date: 04/07/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Schleicher, Brett Daniel, Joo, Michael
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US14/720,718
• Publication Number:
  US 20150250998A1
• Time in Patent Office: 683 Days
• Field of Search: 607 2, 607116, 607126
• 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
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

An anchoring unit for an implantable lead includes a body, a plurality of anchoring members, and at least one connecting element coupling together at least two of the anchoring members that are positioned adjacent to one another. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end, a second end, and a longitudinal axis extending therebetween. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. Each anchoring member has a proximal end and a distal end. The proximal end of each anchoring member extends from the body and the distal end of each anchoring member anchors to patient tissue upon implantation of the anchoring unit into the patient.

Claims

1. An implantable lead, comprising:

a lead body having a proximal end portion, a distal end portion, and an outer surface;

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 electrodes to the terminals; and

at least one anchoring unit disposed along the lead body, each of the at least one anchoring unit comprising

a body configured and arranged for positioning along a portion of the outer surface of the lead body, the body having a first end and a second end and a longitudinal axis extending therebetween, the first end being configured and arranged for placement on the lead body so that the first end is positioned more distally on the lead than the second end;

a plurality of anchoring members extending from the body of the anchoring unit and away from the lead body, each anchoring member having a proximal end and a distal end, the proximal end of each anchoring member coupled to the body and the distal end of each anchoring member configured and arranged for extending into tissue of a patient to anchor the anchoring unit to the tissue of the patient upon implantation of the implantable lead into the patient; and

a conical sheath completely covering each of the plurality of anchoring member;

wherein each of the plurality of anchoring members and the sheath is configured and arranged to fold flat when the lead is inserted into a cannula.

2. The lead of claim 1, wherein the sheath comprises continuous, conical sheet stretching between and over the plurality of anchoring members.

3. The lead of claim 1, wherein at least one of the plurality of anchoring members extends from the second end of the body.

4. The lead of claim 1, wherein at least one of the plurality of anchoring members extends from the second end of the body such that the at least one anchoring member forms an angle with the longitudinal axis of the body that is at least ninety degrees.

5. The lead of claim 1, wherein at least one of the plurality of anchoring members extends from the first end of the body.

6. The lead of claim 1, wherein the distal end and the proximal end of at least one of the plurality of anchoring members have equal widths.

7. The lead of claim 1, wherein tissue ingrowth forms over at least a portion of the at least one anchoring unit during a useful lifespan of the at least one anchoring unit.

8. An electrical stimulating system comprising:

the lead of claim 1;

a control module configured and arranged to electrically couple to the proximal end portion of the lead body, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead, 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, and

a plurality of connector contacts disposed in the connector housing, the 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.

9. The electrical stimulating system of claim 8, wherein the connector is disposed on the control module.

10. The electrical stimulating system of claim 8, further comprising a lead extension, wherein the connector is disposed on a distal end of the lead extension.

11. The electrical stimulating system of claim 10, wherein the control module further comprises a second connector, wherein the lead extension has a proximal end that couples with the second connector disposed on the control module.

12. A method of stimulating patient tissue comprising:

providing the lead of claim 1;

inserting the lead into a patient such that the electrodes of the lead are in proximity to the patient tissue to be stimulated;

coupling the lead to a control module;

generating electrical signals using the control module; and

propagating the generated electrical signals to the electrodes of the lead.

13. An implantable lead, comprising:

a lead body having a proximal end portion, a distal end portion, and an outer surface;

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 electrodes to the terminals; and

at least one anchoring unit, each of the at least one anchoring unit comprising

a body configured and arranged for positioning along a portion of the outer surface of the lead body, the body having a first end and a second end and a longitudinal axis extending therebetween, the first end being configured and arranged for placement on the lead body so that the first end is positioned more distally on the lead than the second end; and

a sheath disposed concentrically around the lead body and extending outwardly from the body of the anchoring unit and away from the lead body, the sheath comprising a continuous, conical sheet and having a proximal unit and a distal end, the proximal end of the sheath coupled to the body of the anchoring unit and the distal end of the sheath configured and arranged for extending into tissue of a patient to anchor the anchoring unit to the tissue of the patient upon implantation of the implantable lead into the patient;

wherein each of the anchoring units is configured and arranged to fold flat against the outer surface of the lead body when the lead is inserted into a cannula.

14. The lead of claim 13, wherein the distal end of the sheath has a first inner diameter and the proximal end of the sheath has a second inner diameter, wherein the first inner diameter is greater than the second inner diameter.

15. The lead of claim 13, wherein the sheath is configured and arranged to fold when the lead is inserted into a cannula.

16. The lead of claim 13, wherein the lead is configured and arranged to permit ingrowth of tissue between the sheath and the lead body.

17. An electrical stimulating system comprising:

the lead of claim 13;

a control module configured and arranged to electrically couple to the proximal end portion of the lead body, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead of the lead assembly, 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, and

a plurality of connector contacts disposed in the connector housing, the 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.

18. A method of stimulating patient tissue comprising:

providing the lead of claim 13

inserting the lead into a patient such that the electrodes of the lead are in proximity to the patient tissue to be stimulated;

coupling the lead to a control module;

generating electrical signals using the control module; and

propagating the generated electrical signals to the electrodes of the lead.