Binding Component

• US 20080119892A1
• Filed: 12/06/2005
• Published: 05/22/2008
• Est. Priority Date: 12/06/2004
• Status: Active Grant

• Current Assignee: Ecole de technologie superieure
• Original Assignee: Institut De Cardiologie De Montrã©Al, Socovar Societe En Commandite
• Inventors: Cartier, Raymond, Baril, Yannick, Terriault, Patrick, Brailovski, Vladimir
• Granted Patent: US 8,308,761 B2
• Time in Patent Office: Days
• US Class Current: 606/215
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/82 for bone cerclage apparatus for manipulating wires or straps A61B17/8861; wires, bands or straps other than cerclage A61B17/842
• CPC Class Codes: A61B 17/823 for the sternum
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

A binding component for binding together a pair of biological tissues. The binding component includes an elongated body defining a body longitudinal axis, the body being made, at least in part, of a shape memory material. The body is configured and sized so as to be both substantially flexible and substantially compressible in a direction substantially perpendicular to said longitudinal axis.

Claims

1. A binding component for binding together a pair of biological tissues, said binding component comprising:

an elongated body defining a body longitudinal axis;

said body being made, at least in part, of a shape memory material;

said body being configured and sized so as to be both substantially flexible and substantially compressible in a direction substantially perpendicular to said longitudinal axis.

2. A binding component as recited in claim 1 wherein said body has a substantially uniform moment of inertia of bending in all directions.

3. A binding component as recited in claim 2 wherein said body has a substantially disc-shaped cross-sectional configuration when radially uncompressed.

4. A binding component as recited in claim 2 wherein said body has a substantially hollow tubular configuration.

5. A binding component as recited in claim 4 wherein said body has a substantially annular cross-sectional configuration when radially uncompressed.

6. A binding component as recited in claim 5 wherein said body is radially compressible towards a compressed configuration wherein said body has a substantially ovaloid cross-section.

7. A binding component as recited in claim 6 wherein said ovaloid configuration defines an oval long axis and an oval short axis, the ratio between said oval long and short axes being approximately between 1 and 3 when said binding component is at least partially bent around a section of a sternum.

8. A binding component as recited in claim 5 wherein said body defines a lumen extending longitudinally therethrough, said body defining a body inner diameter in contact with said lumen and a body outer diameter, said body defining a body thickness between said body inner and outer diameters, said body thickness having a value of approximately between 0.1 and 0.3 mm.

9. A binding component as recited in claim 5 wherein said body defines a lumen extending longitudinally therethrough, said body defining a body inner diameter in contact with said lumen and a body outer diameter, the ratio of said body outer diameter to said body inner diameter having a value of approximately between 1.1 and 1.3.

10. A binding component as recited in claim 5 wherein said body is made of braided filaments of a shape memory material, said shape memory material demonstrating superelastic properties when subjected to temperatures substantially in the range of expected human body temperatures.

11. A binding component as recited in claim 10 wherein said shape memory material is selected from the group consisting of nitinol, other biocompatible shape memory alloys and shape memory polymers.

12. A binding component as recited in claim 10 wherein said body is made up of between 16 and 72 braided filaments.

13. A binding component as recited in claim 12 wherein said body is made up of approximately 24 braided filaments.

14. A binding component as recited in claim 12 wherein the thread of said braided filaments varies between 10 mm and 30 mm.

15. A binding component as recited in claim 14 wherein the thread of said braided filaments is approximately 12.7 mm.

16. A binding component as recited in claim 10 wherein said body is made up of approximately 24 braided filaments, each of said braided filaments has a denier of approximately 5000, and the thread of said braided filaments is approximately 12.7 mm.

17. A binding component as recited in claim 10 wherein said filaments cross over each other on the surface of said body in a criss-cross pattern.

18. A method for binding biological tissues together, the biological tissues having a yield limit beyond which the biological tissues are irreversibly deformed, said method including the steps of:

selecting a suitable binding component comprising an elongated body defining a body longitudinal axis;

said body being made, at least in part, of a shape memory material;

said body being configured and sized so as to be both substantially flexible and substantially compressible in a direction substantially perpendicular to said longitudinal axis;

positioning said binding component in a binding configuration wherein said binding component biases said biological tissues in an opposite contacting relationship relative to each other; and

,

inducing a prestrain into at least part of said binding component.

19. A method as recited in claim 18 wherein said prestrain corresponds to that generated by a stress having a magnitude between σ

_Ms and σ

_Mf.

20. A method as recited in claim 19, wherein:

said binding component is at least in part prestrained with a prestrain causing the generation of a force within an interval of from about 80 percent to about 95 percent of the yield limit after said positioning of said binding component;

the biological tissues are bones and the binding component has a binding component ultimate tensile strength, said binding component ultimate tensile strength being within the interval of from about 200 N to about 300 N;

said body has a composition, a configuration and dimensions such that an inflection point between an upper plateau of a force-displacement relationship of said binding component and a linear force-displacement relationship representing an elastic deformation of a stress-induced martensite phase in said binding component is substantially coincident with a force and a displacement representative of the prestrain in the binding component; and

said body has a composition, a configuration and dimensions such that a difference in force between a lower plateau of the force-displacement relationship of said binding component and the upper plateau is minimal.

21. A method for manufacturing a binding component, said method comprising:

braiding filaments of shape-memory material into an elongated body defining a body longitudinal axis;

said body being configured and sized so as to be both substantially flexible and substantially compressible in a direction substantially perpendicular to said longitudinal axis.

22. A method as recited in claim 21 further comprising the step of treating said body so that said shape memory material demonstrates superelastic properties when subjected to temperatures substantially in the range of expected human body temperatures

23. A method as recited in claim 21 further comprising the step of:

Subjecting said body to a thermal treatment at a temperature between 200°

C. and 700°

C. for a period of between 30 minutes and 30 hours.

24. A method as recited in claim 21 further comprising the step of applying to said body at least one therapeutic or prophylactic surgically useful substance.

25. A binding component for binding together a pair of biological tissues, said binding component comprising:

an elongated body defining a body longitudinal axis;

said body being made, at least in part, of a shape memory material;

said body being provided with at least one therapeutic or prophylactic surgically useful substance.

26. A binding component as recited in claim 25, wherein said substance is selected from the group including substances providing osteogenic capabilities, substances promoting wound repair and/or tissue growth, and substances having anti-microbial properties.

27. A binding component as recited in claim 25 wherein said body is designed to release to or around the sternum an osteogenic factor and/or an angiogenic factor.

28. A binding component as recited in claim 25 wherein said body allows selective distribution of substances taken from the group including HGF, VEGF, BMP, PDGF, aFGF, bFGF, TGF alpha, and TGF beta.

29. A binding component as recited in claim 28, wherein said body is designed to release the osteogenic factor and/or angiogenic factor in a controlled manner.

30. A method for binding biological tissues together, the biological tissues having a yield limit beyond which the biological tissues are irreversibly deformed, said method comprising:

selecting a suitable binding component comprising an elongated body defining a body longitudinal axis;

said body being made, at least in part, of a shape memory material;

positioning said binding component in a binding configuration wherein said binding component biases said biological tissues in an opposite contacting relationship relative to each other;

wherein said binding component is at least in part prestrained with a prestrain causing the generation of a force within an interval of from about 80 percent to about 95 percent of the yield limit after said positioning of said binding component.

31. A method as defined in claim 30, wherein said prestrain causes the generation of a force of about 90 percent of the yield limit after said positioning of said binding component.

32. A method as defined in claim 30, wherein the biological tissues are bones and the binding component has a binding component ultimate tensile strength, said binding component ultimate tensile strength being within the interval of from about 200 N to about 300 N.

33. A method as defined in claim 32, wherein said binding component ultimate tensile strength is about 250 N.

34. A method as defined in claim 30, wherein said prestrain corresponds to that generated by a stress having a magnitude between σ

_Ms and σ

_Mf.

35. A method as defined in claim 34, wherein said body has a composition, a configuration and dimensions such that an inflection point between an upper plateau of a force-displacement relationship of said binding component and a linear force-displacement relationship representing an elastic deformation of a stress-induced martensite phase in said binding component is substantially coincident with a force and a displacement representative of the prestrain in the binding component.

36. A method as defined in claim 35, wherein said body has a composition, a configuration and dimensions such that a difference in force between a lower plateau of the force-displacement relationship of said binding component and the upper plateau is minimal.

37. A method as defined in claim 30, wherein

the biological tissues are bones and the binding component has a binding component ultimate tensile strength, said binding component ultimate tensile strength being within the interval of from about 200 N to about 300 N;

said prestrain corresponds to that generated by a stress having a magnitude between σ

_Ms and σ

_Mf;

said body has a composition, a configuration and dimensions such that an inflection point between an upper plateau of a force-displacement relationship of said binding component and a linear force-displacement relationship representing an elastic deformation of a stress-induced martensite phase in said binding component is substantially coincident with a force and a displacement representative of the prestrain in the binding component; and

said body has a composition, a configuration and dimensions such that a difference in force between a lower plateau of the force-displacement relationship of said binding component and the upper plateau is minimal.

38. A method as defined in claim 37, wherein said body is configured and sized so as to be both substantially flexible and substantially compressible in a direction substantially perpendicular to said longitudinal axis.

39. A method as defined in claim 38, further comprising measuring the density of the bones and determining the yield limit of the bones using at least in part the measured density of the bones.

40. A method for manufacturing a binding component for binding bones, said method comprising:

braiding filaments of shape-memory material into an elongated body defining a body longitudinal axis;

said body being configured and sized so as to be both substantially flexible and substantially compressible in a direction substantially perpendicular to said longitudinal axis;

setting the composition, dimensions and configuration of said body by modeling the bones as a linear elastic material having a yield limit beyond which the bones are irreversibly deformed and modeling the shape-memory material as having a stress-strain relationship including an hysteresis, and ensuring that;

said binding component has a binding component ultimate tensile strength within the interval of from about 200 N to about 300 N;

said body is at least in part prestrained with a prestrain corresponds to that generated by a stress having a magnitude between σ

_Ms and σ

_Mf, said prestrain corresponding to that generated by a force having a magnitude within an interval of from about 80 percent to about 95 percent of the yield limit;

an inflection point between an upper plateau of a force-displacement relationship of said binding component and a linear force-displacement relationship representing an elastic deformation of a stress-induced martensite phase in said binding component is substantially coincident with a force and a displacement representative of the prestrain in the binding component; and

a difference in force between a lower plateau of the force-displacement relationship of said binding component and the upper plateau is minimized.

41. A binding component for binding together a pair of bones, said binding component comprising:

an elongated body defining a body longitudinal axis;

said body having a substantially hollow tubular configuration defining a tube outer diameter;

said body being made of braided filaments of a shape memory material, said shape memory material demonstrating superelastic properties when subjected to temperatures substantially in the range of expected human body temperatures;

said binding component having a binding component ultimate tensile strength, said binding component ultimate tensile strength being within the interval of from about 200 N to about 300 N;

said body being at least in part prestrained with a prestrain corresponding to that generated by a stress having a magnitude between σ

_Ms and σ

_Mf;

said body having a composition, a configuration and dimensions such that an inflection point between an upper plateau of a force-displacement relationship of said binding component and a linear force-displacement relationship representing an elastic deformation of a stress-induced martensite phase in said binding component is substantially coincident with a force and a displacement representative of the prestrain in the body component; and

said body having a composition, a configuration and dimensions such that a difference in force between a lower plateau of the force-displacement relationship of said binding component and the upper plateau of the force-displacement relationship of said binding component is minimal.

42. A binding component as recited in claim 41, wherein a difference in force between the lower plateau of the force-displacement relationship of said binding component and the upper plateau of the force-displacement relationship of said binding component is equal to from about 10 percent to about 30 percent of the force to which the prestrain corresponds.

43. A binding component as recited in claim 41, wherein said body is at least in part prestrained with a prestrain corresponding to that generated by a force having a magnitude of from about 55 N to about 65 N.

44. A binding component as recited in claim 43, wherein said body is at least in part prestrained with a prestrain corresponding to that generated by a force having a magnitude of about 60 N.

45. A binding component as recited in claim 41, wherein said body is made up of approximately 24 braided filaments having a diameter of about 0.075 mm, the thread of said braided filaments being of about 12.5 mm, said tube outer diameter being of about 3 mm.

46. A binding component as recited in claim 41 wherein said shape memory material is selected from the group consisting of Nitinol, other biocompatible shape memory alloys and shape memory polymers.