Medical device anchor and method of manufacture thereof

• US 20070078399A1
• Filed: 03/07/2006
• Published: 04/05/2007
• Est. Priority Date: 03/07/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Olson, Robert
• Granted Patent: US 7,591,970 B2
• Time in Patent Office: Days
• US Class Current: 604/175
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 5/1418 Clips, separators or the like for supporting tubes or leads
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A medical device anchor for use with electrical stimulation leads or catheters, and method of manufacture thereof. The anchor may include a gripping structure and a body portion molded on the gripping structure. The gripping structure forms a serpentine arrangement of a continuous nature with axial segments alternately interconnected between shoulder segments and bridging segments. The shoulder segments extend radially outward relative to the through hole further than the axial segments. The body portion may be formed by molding to securely capture the shoulder in the body portion, with the body portion being molded of material that is softer and more compliant than the gripping structure.

Claims

1. A medical device anchor for use with electrical stimulation leads or catheters comprising:

a gripping structure having a generally tubular configuration defining axial and radial directions, the gripping structure being defined by an annular shoulder and a plurality of compressible beams extending axially from the annular shoulder wherein the shoulder extends radially outwardly beyond the beams;

a body portion formed by molding around the gripping structure and retain the shoulder within the body portion, the gripping means and body portion defining a lumen extending in the axial direction for receiving a lead or catheter.

2. The medical device anchor according to claim 1 wherein:

the gripping structure has a first end and a second end opposite the first end, each compressible beam having a first end corresponding to the first end of the gripping structure and a second end corresponding to the second end of the gripping structure;

the plurality of compressible beams being arranged in substantially parallel circumferentially spaced apart array defining the generally tubular configuration of the gripping structure

the annular shoulder comprises a plurality of shoulder segments separated from one another in alternating fashion by a plurality of shoulder gaps forming a generally annular array of shoulder segments and shoulder gaps, the first ends of the compressible beam being alternately bridged or unbridged by the shoulder segments and shoulder gaps;

the gripping structure further comprises a plurality of bridging segments separated from one another in alternating fashion by a plurality of unbridged gaps forming a generally annular array of bridging portions and unbridged gaps, the second ends of the compressible beam being alternately bridged or unbridged by the bridging segments and unbridged gaps such that the gripping structure forms a serpentine arrangement of a continuous nature with the compressible beams alternately interconnected between shoulder segments and bridging segments.

3. The medical device anchor of claim 2, wherein the body portion is formed of soft, resiliently compressible material, the gripping structure being formed of relatively stiff in comparison with the material of the body portion.

4. The medical device anchor of claim 3, wherein the outer surface of the body portion forms an array of geometric protrusions.

5. The medical device anchor of claim 3 further comprising a sleeve portion covering the compressible axial segments, the body portion being formed by molding the body portion around the sleeve portion and the shoulders.

6. The medical device anchor of claim 3 wherein each of the axial segments include a grip-enhancing texture along a radially-inwardly facing surface for engaging a lead or catheter in use of the medical device anchor.

7. The medical device anchor of claim 6 wherein the grip-enhancing texture is provided by threads or grooves formed along the radially-inwardly facing surfaces of the axial segments.

8. The medical device anchor of claim 7 wherein at least one of the shoulder segments has a portion extending axially beyond the first ends, the body portion being molded to substantially surround such portion.

9. The medical device anchor of claim 8 wherein the axial segment array defines a first infinite cylinder surrounding and tangent with the axial segment array, the at least one of the shoulder segments being substantially entirely radially outward of the first infinite cylinder.

10. The medical device of claim 9 wherein the axial segments define a second infinite cylinder tangent with the axial segment array and sandwiching the axial segment array between the second infinite cylinder and the first infinite cylinder, the bridging segments being substantially enclosed between the first and second infinite cylinders.

11. The medical device anchor of claim 9 wherein the plurality of shoulder segments are substantially entirely radially outward of the first infinite cylinder.

13. The medical device of claim 11 wherein the axial segments define a second infinite cylinder tangent with the axial segment array and sandwiching the axial segment array between the second infinite cylinder and the first infinite cylinder, the bridging segments being substantially enclosed between the first and second infinite cylinders.

12. The medical device anchor of claim 111 wherein the bridging segments are substantially entirely radially outward of the first infinite cylinder.

14. A medical device anchor for use with electrical stimulation leads or catheters comprising:

a gripping structure forming a through hole having a circumference, wherein axial, circumferential and radial directions are defined relative to the through hole, the gripping structure having;

a plurality of compressible axial segments arranged in a generally parallel, spaced apart array along the circumference of the through hole, each axial segment having first and second ends; and

a plurality of shoulder segments separated from one another in alternating fashion by a plurality of shoulder gaps forming a generally annular array of shoulder segments and shoulder gaps, the first ends of the axial segments being alternately bridged or unbridged by the shoulder segments and shoulder gaps, the shoulder segments extending radially outward relative to the through hole further than the axial segments; and

a plurality of bridging segments separated from one another in alternating fashion by a plurality of unbridged gaps forming a generally annular array of bridging portions and unbridged gaps, the second ends of the axial segments being alternately bridged or unbridged by the bridging segments and unbridged gaps such that the gripping structure forms a serpentine arrangement of a continuous nature with the axial segments alternately interconnected between shoulder segments and bridging segments; and

a body portion formed by molding to retain the shoulders within the body portion, the gripping structure and body portion defining a lumen for receiving a lead or catheter.

15. The medical device anchor of claim 14 wherein at least one of the shoulder segments has a portion extending axially beyond the first ends, the body portion being molded to substantially surround such portion.

16. The medical device anchor of claim 15 wherein the axial segment array defines a first infinite cylinder surrounding and tangent with the axial segment array, the at least one of the shoulder segments being substantially entirely radially outward of the first infinite cylinder.

17. The medical device of claim 16 wherein the axial segments define a second infinite cylinder tangent with the axial segment array and sandwiching the axial segment array between the second infinite cylinder and the first infinite cylinder, the bridging segments being substantially enclosed between the first and second infinite cylinders.

18. The medical device anchor of claim 16 wherein the plurality of shoulder segments are substantially entirely radially outward of the first infinite cylinder.

19. The medical device anchor of claim 18 wherein the bridging segments are substantially entirely radially outward of the first infinite cylinder.

20. The medical device of claim 18 wherein the axial segments define a second infinite cylinder tangent with the axial segment array and sandwiching the axial segment array between the second infinite cylinder and the first infinite cylinder, the bridging segments being substantially enclosed between the first and second infinite cylinders.

21. The medical device anchor according to claim 20 wherein the gripping structure is formed of a material having different mechanical properties than the material of the body portion.

22. The medical device anchor of claim 21, wherein the body portion is formed of soft, resiliently compressible material, the gripping structure being formed of relatively stiff in comparison with the material of the body portion.

23. The medical device anchor of claim 22, wherein the outer surface of the body portion forms an array of geometric protrusions.

24. The medical device anchor of claim 14 wherein the bridging segments extend radially outward relative to the through hole further than the axial segments.

25. The medical device anchor of claim 14 further comprising a sleeve portion covering the compressible axial segments, the body portion being formed by molding body portion around the sleeve portion and the shoulders.

26. The medical device anchor of claim 14 wherein each of the axial segments include a grip-enhancing texture along a radially-inwardly facing surface for engaging a lead or catheter in use of the medical device anchor.

27. The medical device anchor of claim 26 wherein the grip-enhancing texture is provided by threads or grooves formed along the radially-inwardly facing surfaces of the axial segments.

29. The suture sleeve assembly of claim 27 wherein the two shoulders define the suture-receiving area of the suture sleeve assembly such that sutures are intended to be tied around the suture sleeve between the two shoulders.

30. The suture sleeve assembly of claim 27 wherein the two shoulders form structures that are securely held within the soft elastomeric material of the suture sleeve.

31. The suture sleeve assembly of claim 30 in combination with a suture tied thereon.

32. The suture sleeve assembly of claim 31 further in combination with a lead or catheter anchored thereby.

28. A suture sleeve assembly comprising a suture sleeve made of soft elastomeric material and means associated with the suture sleeve for enhancing gripping of a lead body by the suture sleeve, said suture sleeve comprising a tubular sleeve having a throughbore adapted to receive a lead body or catheter, the gripping enhancing means being made of a material that is different than the material of the suture sleeve and which is stiff but flexible, and said gripping enhancing means being positioned to extend within and longitudinally of an elongate axis of the suture sleeve in a suture-receiving area of the suture sleeve intended to receive one or more sutures thereby to disperse any stress placed upon said suture sleeve when sutures are tied along the suture-receiving area, and the suture sleeve assembly being radially compressible upon the placement and tying of a suture around the suture sleeve assembly in the suture-receiving area to facilitate generally uniform gripping of the lead body or catheter by the suture sleeve assembly along the length of the gripping enhancing means, the gripping enhancing means comprising a cylindrical flexible framework within a suture sleeve forming a cylindrical envelope, the framework being defined by an undulating or sinuous arrangement of a continuous rib extending in axial segments connected by arcuate segments wherein the arcuate segments define two shoulders extending radially outwardly relative to the through bore farther than the axial segments, and the two shoulders define the suture-receiving area.

33. A method of manufacturing the medical device anchor, the method comprising:

forming a gripping structure defining a through hole having a circumference, wherein axial, circumferential and radial directions are defined relative to the through hole, the gripping structure forming a continuous, serpentine arrangement having a plurality of compressible axial segments arranged in a generally parallel, spaced apart array along the circumference of the through hole, each axial segment having first and second ends; and

a plurality of shoulder segments separated from one another in alternating fashion by a plurality of shoulder gaps forming a generally annular array of shoulder segments and shoulder gaps, the first ends of the axial segments being alternately bridged or unbridged by the shoulder segments and shoulder gaps, the shoulder segments extending radially outward relative to the through hole further than the axial segments;

a plurality of bridging segments separated from one another in alternating fashion by a plurality of unbridged gaps forming a generally annular array of bridging portions and unbridged gaps, the second ends of the axial segments being alternately bridged or unbridged by the bridging segments and unbridged gaps such that the gripping structure forms a serpentine arrangement of a continuous nature with the compressible beams alternately interconnected between shoulder segments and bridging segments; and

molding a body portion on the gripping structure to securely capture the shoulder in the body portion, the body portion being molded of material that is softer and more compliant than the gripping structure.

34. The medical device anchor of claim 33 wherein the step of forming a gripping structure further includes:

forming a grip-enhancing texture along a radially-inwardly facing surface of each axial segment, the grip-enhancing texture being formed for frictional engagement with a lead or catheter in use of the medical device anchor.

35. The medical device anchor of claim 34 wherein the step of forming a grip-enhancing texture along a radially-inwardly facing surface of each axial segment further includes:

forming threads or grooves along the radially-inwardly facing surfaces of the axial segments.

36. A method of manufacturing the medical device anchor, the method comprising:

forming a gripping structure defining a through hole having a circumference, wherein axial, circumferential and radial directions are defined relative to the through hole, the gripping structure forming a continuous, serpentine arrangement having a plurality of compressible axial segments arranged in a generally parallel, spaced apart array along the circumference of the through hole, each axial segment having first and second ends; and

a plurality of shoulder segments separated from one another in alternating fashion by a plurality of shoulder gaps forming a generally annular array of shoulder segments and shoulder gaps, the first ends of the axial segments being alternately bridged or unbridged by the shoulder segments and shoulder gaps, the shoulder segments extending radially outward relative to the through hole further than the axial segments;

a plurality of bridging segments separated from one another in alternating fashion by a plurality of unbridged gaps forming a generally annular array of bridging portions and unbridged gaps, the second ends of the axial segments being alternately bridged or unbridged by the bridging segments and unbridged gaps such that the gripping structure forms a serpentine arrangement of a continuous nature with the axial segments alternately interconnected between shoulder segments and bridging segments; and

stretching a body portion on the gripping structure with the shoulder segments securely captured by the body portion, the body portion being molded of material that is softer and more compliant than the gripping structure.

37. The medical device anchor of claim 36 wherein the step of forming a gripping structure further includes:

forming a grip-enhancing texture along a radially-inwardly facing surface of each axial segment, the grip-enhancing texture being formed for frictional engagement with a lead or catheter in use of the medical device anchor.

38. The medical device anchor of claim 37 wherein the step of forming a grip-enhancing texture along a radially-inwardly facing surface of each axial segment further includes:

forming threads or grooves along the radially-inwardly facing surfaces of the axial segments.