Anchor sleeve for implantable lead

• US 9,026,227 B2
• Filed: 07/14/2014
• Issued: 05/05/2015
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Daglow, Terry D.
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US14/330,033
• Publication Number:
  US 20140323972A1
• Time in Patent Office: 295 Days
• Field of Search: None
• US Class Current: 607/116
• CPC Class Codes: A61M 2005/1416 placed on the body of the patient
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

An anchor sleeve for securing a therapy delivery element, such as a stimulation lead or catheter, within a living body, that includes an inner sleeve with pre-formed locations of weakness that facilitate localized deformation. The anchor includes a deformable outer sleeve with a primary lumen extending along an axis. The outer surface of the outer sleeve includes a plurality of suture grooves oriented generally concentric to the axis. The inner sleeve includes a plurality of beams connected at deflection regions arranged around a secondary lumen. The inner sleeve is located in the primary lumen adjacent to the suture grooves so that the secondary lumen is generally concentric with the primary lumen. A plurality of locations of weakness are preformed in each of the beams to facilitate localized deformation in response to a radially inward force applied around the suture grooves by a suture material.

Claims

1. An anchor for securing a therapy delivery element to a desired location within a living body, the anchor comprising:

a deformable outer sleeve including a primary lumen extending along an axis;

an inner sleeve including a plurality of beams connected at deflection regions arranged around a secondary lumen, the inner sleeve located in and substantially concentric with the primary lumen, wherein the inner sleeve is fixed within the primary lumen of the outer sleeve; and

a plurality of locations of weakness in each of the beams that facilitate localized deformation of the inner sleeve in response to a radially inward force, the plurality of locations of weakness including a plurality of slits extending part-way through a beam width from both a first beam edge and a second beam edge, wherein the slits alternate from extending into the beam width from the first edge to extending from the second edge without being in open communication with each other as the slits extend along the length of the beam, wherein the inner sleeve buckles at the slits in response to the radially inward force to grip the therapy delivery element disposed within the inner sleeve.

2. The anchor of claim 1, wherein the outer sleeve includes an outer surface including at least one suture-receiving portion.

3. The anchor of claim 2, wherein the at least one suture-receiving portion includes at least one suture groove oriented substantially concentrically to the axis.

4. The anchor of claim 2, wherein the radially inward force is applied around the suture-receiving portion by a suture material.

5. The anchor of claim 1, wherein the outer sleeve includes at least a portion extending beyond the inner sleeve.

6. The anchor of claim 1, wherein at least a portion of the primary lumen includes a medical adhesive receiving groove.

7. The anchor of claim 1, wherein the outer sleeve includes a fill port adapted to direct a medical adhesive to at least the primary lumen.

8. An anchor for securing a therapy delivery element to a desired location within a living body, the anchor comprising:

a deformable outer sleeve including a primary lumen extending along an axis; and

an inner sleeve disposed within the outer sleeve, the inner sleeve being fixed within the primary lumen of the outer sleeve, the inner sleeve including at least two beams and a location of weakness within at least one of the beams configured to facilitate localized deformation of the inner sleeve in response to a radially inward force, the location of weakness including at least a first slit and a second slit each extending part-way through a beam width, wherein the first slit extends into the beam width from a first edge and the second slit extends into the beam width from a second edge without being in open communication with each other, wherein the inner sleeve buckles at the location of weakness in response to the radially inward force to contact the therapy delivery element disposed within the inner sleeve.

9. The anchor of claim 8, wherein the outer sleeve includes an outer surface including at least one suture-receiving portion.

10. The anchor of claim 9, wherein the at least one suture-receiving portion includes at least one suture groove oriented substantially concentrically to the axis.

11. The anchor of claim 9, wherein the radially inward force is applied around the suture-receiving portion by a suture material.

12. The anchor of claim 8, wherein the at least two beams include a plurality of beams circumferentially disposed around and defining a secondary lumen of the inner sleeve, wherein a pair of adjacent beams of the plurality of beams are circumferentially connected at a deflection region, the pair of adjacent beams of the plurality of beams being otherwise separated from one another by a gap.

13. The anchor of claim 12, wherein the secondary lumen is substantially concentric with the primary lumen.

14. The anchor of claim 8, wherein the first slit and the second slit each extend radially, with respect to the inner sleeve, through the at least one beam from an inner surface to an outer surface of the at least one beam.

15. An anchor for securing a therapy delivery element to a desired location within a living body, the anchor comprising:

a deformable outer sleeve including a primary lumen extending along an axis;

an inner sleeve including a plurality of beams connected at deflection regions arranged around a secondary lumen, the inner sleeve located in the primary lumen so that the secondary lumen is substantially concentric with the primary lumen, wherein the inner sleeve is fixed within the primary lumen of the outer sleeve; and

a plurality of locations of weakness in each of the beams, the plurality of locations of weakness configured to facilitate localized deformation of the inner sleeve in response to a radially inward force applied around the outer sleeve, the plurality of locations of weakness including a plurality of slits extending part-way through a beam width from both a first beam edge and a second beam edge, wherein the slits alternate from extending into the beam width from the first edge to extending from the second edge without being in open communication with each other as the slits extend along the length of the beam, wherein the inner sleeve buckles at the slits in response to the radially inward force to grip the therapy delivery element disposed within the inner sleeve.

16. The anchor of claim 15, wherein the outer sleeve includes an outer surface including at least one suture-receiving portion.

17. The anchor of claim 16, wherein the at least one suture-receiving portion includes at least one suture groove.

18. The anchor of claim 16, wherein the radially inward force is applied around the suture-receiving portion by a suture material.

19. The anchor of claim 15, wherein the outer sleeve includes at least a portion extending beyond the inner sleeve.

20. The anchor of claim 15, wherein the inner sleeve includes a material configured to plastically deform in response to the radially inward force.