Anchor sleeve for implantable lead

• US 8,849,418 B2
• Filed: 03/11/2011
• Issued: 09/30/2014
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Daglow, Terry Douglas
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US13/045,947
• Publication Number:
  US 20120232626A1
• Time in Patent Office: 1,299 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 comprising a primary lumen extending along an axis, and an outer surface with a plurality of suture grooves oriented substantially concentric to the axis;

an inner sleeve comprising a plurality of beams connected at deflection regions arranged around a secondary lumen, the inner sleeve located in the primary lumen adjacent to the suture grooves 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 that facilitate localized deformation of the inner sleeve in response to a radially inward force applied around the suture grooves by a suture material, 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 comprises distal portions extending beyond the inner sleeve.

3. The anchor of claim 1, wherein at least a portion of the primary lumen comprises grooves adapted to receive a medical adhesive.

4. The anchor of claim 1, wherein the outer sleeve comprises one or more fill ports adapted to direct a medical adhesive to at least the primary lumen.

5. The anchor of claim 1, wherein the outer sleeve comprises at least one fill port with a connector to receive a dispenser containing a medical adhesive.

6. The anchor of claim 1, wherein the inner sleeve comprises a material that plastically deforms in response to the radially inward force.

7. The anchor of claim 1, wherein the inner sleeve comprises one of a thermoplastic material, stainless steel, or Nitinol.

8. The anchor of claim 1, wherein the locations of weakness comprise discontinuities in the beams, including one or more of holes, recesses, or regions thinning.

9. The anchor of claim 1, wherein the localized deformation comprises one or more of bending, twisting, elongation, compression, or a combination thereof.

10. 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 outer surface including a suture groove oriented substantially concentrically to the 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 adjacent to the suture groove 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 that facilitate localized deformation of the inner sleeve in response to a radially inward force applied around the suture grooves by a suture material, 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.

11. The anchor of claim 10, wherein the outer sleeve includes distal portions extending beyond the inner sleeve.

12. The anchor of claim 10, wherein at least a portion of the primary lumen includes a medical adhesive receiving groove.

13. The anchor of claim 10, wherein the outer sleeve includes a fill port adapted to direct a medical adhesive to at least the primary lumen.

14. The anchor of claim 13, wherein the outer sleeve includes more than one fill port.

15. The anchor of claim 13, wherein the fill port is fluidly coupled to a medical adhesive receiving groove of the primary lumen.

16. The anchor of claim 13, wherein the fill port includes a connector configured to receive a medical adhesive dispenser.

17. 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 outer surface including a suture groove oriented substantially concentrically to the axis; and

an inner sleeve disposed within the outer sleeve adjacent the suture groove of the outer surface, 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 applied around the suture grooves by a suture material, 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.

18. The anchor of claim 17, wherein the at least two beams includes 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.

19. The anchor of claim 18, wherein the secondary lumen is substantially concentric with the primary lumen.

20. The anchor of claim 17, 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.

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

a deformable outer sleeve providing a primary lumen extending along a longitudinal axis, the outer sleeve including an outer surface with a plurality of suture grooves oriented substantially concentric to the axis; and

an inner sleeve received in and fixed within the primary lumen of the outer sleeve, the inner sleeve including;

at least four inner beams, each inner beam including a beam width extending from a first edge to a second edge, the beam width being perpendicular to a beam length extending from a beam proximal end to a beam distal end, wherein each beam is spaced from the longitudinal axis;

at least a first proximal deflection portion and a second proximal deflection portion, and at least a third distal deflection portion and a fourth distal deflection portion, wherein proximal ends of the first and second beams are connected at spaced locations to the first proximal deflection portion, distal ends of the second and third beams are connected at spaced locations to the third distal deflection portion, proximal ends of the third and fourth beams are connected at spaced locations to the second proximal deflection portion, and distal ends of the fourth and first beams are connected at spaced locations to the fourth distal deflection portion to thereby create a first axial opening extending from between the fourth and third distal deflection portions and between the first and second beams terminating at the first proximal deflection portion, a second axial opening extending from between the first and second proximal deflection portions and between the second and third beams terminating at the third distal deflection portion, a third axial opening extending from between the third and fourth distal deflection portions and between the third and fourth beams terminating at the second proximal deflection portion, and a fourth axial opening extending from between the second and first proximal deflection portions and between the fourth and first beams terminating at the fourth distal deflection portion; and

a plurality of slits extending part-way through the beam width of each of the inner beams from both the first beam edge and the second beam edge, wherein the slits alternate from extending into the 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 a radially inward force imparted to the outer sleeve to thereby contact a therapy delivery element disposed within the inner sleeve.

22. The anchor of claim 21, wherein each of the plurality of slits extends beyond an imaginary line bisecting the width of a beam and extending from the beam proximal end to the beam distal end.