Method and Apparatus for Tensioning a Suture

• US 20120059418A1
• Filed: 11/14/2011
• Published: 03/08/2012
• Est. Priority Date: 02/03/2006
• Status: Active Grant

• Current Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Denham, Gregory J., Stone, Kevin T., Wack, Michael A.
• Granted Patent: US 9,271,713 B2
• Time in Patent Office: Days
• US Class Current: 606/232
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• 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 17/683 comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
• CPC Class Codes: A61B 17/8076 for the ribs or the sternum
• CPC Class Codes: A61B 17/809 with bone-penetrating elements, e.g. blades or prongs bone staples A61B17/0642; intramedullary nails with a plate at an end A61B17/7233
• CPC Class Codes: A61B 17/823 for the sternum
• CPC Class Codes: A61B 17/842 Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61B 17/8869 Tensioning devices
• CPC Class Codes: A61B 2017/00858 high friction, non-slip on handles A61B2017/00429
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06185 hollow or tubular hollow suture needles A61B2017/061

Abstract

An apparatus can include a tensioning member having a body defining a first bone engaging surface, a second opposite suture receiving surface, and an outer perimeter. First and second suture attachment members can be positioned relative to the second surface and spaced apart from each other, and can be configured to be coupled to a suture. First and second suture engaging members can extend from the second surface and can be positioned in spaced relation to the first and second suture attachment members. Rotation of the tensioning member in a first direction can selectively engage the first and second suture receiving members with the suture, thereby forming a non-linear path of travel of the suture relative to the first and second suture attachment members and suture engaging members and increasing the tension in the suture.

Claims

1. An apparatus for applying tension to a suture, comprising:

a tensioning member including;

a body defining a first bone engaging surface, an opposite second suture receiving surface, and an outer perimeter;

first and second suture attachment members positioned relative to the second surface and spaced apart from each other, the first and second suture attachment members adapted to be coupled to the suture; and

first and second suture engaging members extending from the second surface and positioned in spaced relation to the respective first and second suture attachment members;

wherein rotation of the tensioning member in a first direction is adapted to selectively engage the first and second suture receiving members with the suture thereby forming a non-linear path of travel of the suture relative to the first and second suture attachment members and first and second suture engaging members and increasing the tension in the suture.

2. The apparatus of claim 1, wherein the first and second suture engaging members each comprise a ramped member having an upper surface inclined relative to the second surface of the body and adapted to facilitate sliding of the suture relative thereto, and a side surface extending relative to the second surface of the body and the ramped surface, the side surface sized and shaped to engage and retain the suture.

3. The apparatus of claim 2, wherein each ramped member is positioned proximate the outer perimeter;

and

wherein upon rotation of the tensioning member, the inclined surface of each ramped member is adapted to slidably engage the suture and facilitate the suture sliding over the inclined surface and engaging the side surface of each ramped member.

4. The apparatus of claim 3, wherein the ramped member of the first and second suture engaging members includes a plurality of ramped members, each of the plurality of ramped members being orientated consecutively along an arcuate path.

5. The apparatus of claim 4, wherein the outer perimeter of the body comprises a circular shape, and wherein each of the first and second plurality of ramped members is positioned along the arcuate path that substantially aligns with the circular perimeter of the body.

6. The apparatus of claim 2, wherein the first and second attachment members each comprise a post having an undercut adapted to receive the suture, the posts being centrally positioned relative to the outer perimeter of the body.

7. The apparatus of claim 2, wherein the suture comprises an adjustable suture construct having first and second adjustable loops extending from a passage portion, the first and second adjustable loops being received by one of the attachment members and the passage portion being received by the other of the attachment members.

8. The apparatus of claim 2, wherein the suture comprises an adjustable suture construct having first and second adjustable loops extending from a passage portion, the first and second adjustable loops being received by the respective first and second attachment members.

9. The apparatus of claim 8, wherein the adjustable suture construct includes a suture having a first end that extends through a first aperture defined by the suture into the passage portion and out a second aperture defined by the suture so that the first end is outside of the passage portion and defines the first adjustable loop, and having a second end that extends through the second aperture into the passage portion and out the first aperture so that the second end is outside of the passage portion and defines the second adjustable loop.

10. The apparatus of claim 2, further comprising at least one driver engaging aperture configured to receive a driver for rotating the tensioning member.

11. The apparatus of claim 10, wherein the at least one driver engaging aperture includes a hexagon shaped sidewall and is positioned in the body between the first and second attachment members.

12. The apparatus of claim 10, wherein the at least one driver engaging aperture includes first and second apertures positioned in the respective first and second suture attachment members, the first and second apertures configured to receive first and second projections extending from a distal end of the driver.

13. The apparatus of claim 2, wherein the first and second suture attachment members comprise first and second posts extending from the second surface of the body, the first and second posts having sidewalls positioned in opposed spaced relation to each other so as to form a channel therebetween, the channel adapted to receive the suture therethrough.

14. The apparatus of claim 2, wherein the outer perimeter of the body includes a rectangular shape having a longitudinal centerline, the first suture attachment and suture engaging members being positioned on a first side of the longitudinal centerline and the second suture attachment and suture receiving members being positioned on a second opposite side of the longitudinal centerline.

15. A method for applying tension to a flexible member, comprising:

positioning a tensioning member relative to a first bone portion and a second bone portion, the tensioning member having first and second flexible member attachment members and a corresponding set of first and second flexible member engaging members extending therefrom;

positioning the flexible member about the first and second bone portions;

coupling the flexible member to the first and second attachment members;

tensioning the flexible member to draw the first and second bone portions toward each other under a first tension;

rotating the tensioning member such that the first and second attachment members draw the flexible member in opposite directions applying additional tension to the flexible member to place the flexible member and the first and second bone portions under a second tension;

engaging the flexible member with the first and second flexible member engaging members and creating a non-linearity in the flexible member about each of the flexible member engaging members; and

maintaining the second tension via engagement of the flexible member with the first and second attachment members and the first and second engagement members in an absence of an external force.

16. The method of claim 15, wherein positioning the flexible member about the first and second bone portions includes wrapping the flexible member around the first and second bone portions.

17. The method of claim 15, wherein coupling the flexible member to the first and second attachment members includes coupling a first adjustable loop of an adjustable suture construct formed from a suture to a first post and coupling a second adjustable loop of the adjustable suture construct to a second post, the first and second adjustable loops extending from a passage portion of the adjustable suture construct.

18. The method of claim 15, wherein coupling the flexible member to the first and second attachment members includes coupling an adjustable suture construct formed from a suture to the first and second attachment members, the adjustable suture construct having a first end of the suture that extends through a first aperture defined by the suture into the passage portion and out a second aperture defined by the suture so that the first end is outside of the passage portion and defines a first adjustable loop, and having a second end of the suture that extends through the second aperture into the passage portion and out the first aperture so that the second end is outside of the passage portion and defines a second adjustable loop.

19. The method of claim 18, wherein coupling the flexible member to the first and second attachment members includes coupling the first adjustable loop to the first attachment member and coupling the second adjustable loop to the second attachment member.

20. The method of claim 18, wherein coupling the flexible member to the first and second attachment members includes coupling the first and second adjustable loops to the first attachment member and coupling the passage portion to the second attachment member.

21. The method of claim 15, wherein tensioning the flexible member to draw the first and second bone portions toward each other under a first tension includes tensioning the flexible member relative to the first and second attachment members.

22. The method of claim 15, wherein rotating the tensioning member such that the attachment members draw the flexible member in opposite directions applying additional tension to the flexible member to place the flexible member and the first and second bone portions under a second tension includes engaging a driver with the tensioning member and rotating the driver to rotate the tensioning member.

23. The method of claim 15, wherein engaging the flexible member with the first and second flexible member engaging members includes:

sliding the flexible member over a first ramped surface of the flexible member engaging members; and

engaging the flexible member against a second side surface of the flexible member engaging member;

wherein the flexible member is bent around the second side surface of each flexible member engaging member thereby creating the non-linearity.

24. The method of claim 23, wherein the first and second flexible member engaging members include a first and second plurality of flexible member engaging members each having the first ramped surface and second side surface, each plurality of flexible member engaging members being positioned consecutively in a single row;

wherein continued rotation of the tensioning member slides the flexible member over consecutive flexible member engaging members of each of the first and second plurality of flexible member engaging members; and

wherein engaging the flexible member with each consecutive ramped member second side surface increases the second tension applied to the flexible member and first and second bone portions.

25. The method of claim 15, wherein tensioning the flexible member to draw the first and second bone portions toward each other under a first tension includes compressing the first and second bone portions of the same fractured bone.

26. The method of claim 15, wherein tensioning the flexible member to draw the first and second bone portions toward each other under a first tension includes drawing the first and second bone portions of a different bone toward each other.

27. The method of claim 15, wherein engaging the flexible member with the first and second flexible member engaging members and creating a non-linearity in the flexible member about each of the flexible member engaging members includes engaging a first side of the flexible member with the first engaging member and engaging a second side of the flexible member opposite the first side with the second engaging member.

28. The method of claim 15, wherein engaging the flexible member with the first and second flexible member engaging members and creating a non-linearity in the flexible member about each of the flexible member engaging members includes:

engaging a first side of the flexible member with the first attachment member and a second opposite side of the flexible member with the first engaging member; and

engaging the second side of the flexible member with the second attachment member and the first side of the flexible member with the second engaging member.

29. A method for applying tension to a suture, comprising:

positioning a tensioning member relative to a first bone portion and a second bone portion, the tensioning member having first and second suture attachment members and a corresponding first and second plurality of suture engaging members extending therefrom;

positioning an adjustable suture construct about the first and second bone portions;

coupling first and second adjustable loops of the adjustable suture construct to the first and second attachment members;

tensioning free ends of the adjustable suture construct to reduce a size of the first and second adjustable loops and draw the first and second bone portions toward each other under a first tension;

rotating the tensioning member such that the first and second attachment members draw the adjustable suture construct in opposite directions applying additional tension to the suture construct to place the suture construct and the first and second bone portions under a second tension;

engaging the first and second adjustable loops with a respective one of the plurality of first and second suture engaging members and creating a non-linearity in the adjustable loops about each of the one of the plurality of first and second suture engaging members; and

maintaining the second tension via engagement of the first and second adjustable loops with the first and second suture attachment members and the one of the plurality of first and second suture engagement members in an absence of an external force.

30. The method of claim 29, wherein engaging the first and second adjustable loops with the respective one of the plurality of first and second suture engaging members and creating the non-linearity in the adjustable loops about each of the one of the plurality of first and second suture engaging members includes:

sliding the first and second adjustable loops over a ramped surface of the respective one of the plurality of first and second engaging members; and

engaging the first and second adjustable loops against a side surface of the respective one of the plurality of first and second engaging members;

wherein the first and second adjustable loops are bent around the side surfaces thereby creating the non-linearity.

31. The method of claim 30, wherein the first and second plurality of suture engaging members are each positioned consecutively in a single row, each consecutively positioned suture engaging member after a first suture engaging member of the first and second plurality of suture engaging members providing additional tension to the adjustable suture construct upon engagement with the respective first and second adjustable loops;

and

wherein sliding the first and second adjustable loops over the ramped surface of the respective one of the plurality of first and second engaging members includes rotating the tensioning member to slide the first and second adjustable loops over the ramped surfaces of a respective sub-plurality of the plurality of first and second suture engaging members.

32. The method of claim 29, wherein tensioning free ends of the adjustable suture construct to reduce a size of the first and second adjustable loops and draw the first and second bone portions toward each other under a first tension includes compressing the first and second bone portions of the same fractured bone.

33. The method of claim 32, wherein tensioning free ends of the adjustable suture construct to reduce a size of the first and second adjustable loops includes compressing the first and second bone portions of a sectioned sternum.

34. The method of claim 29, wherein tensioning free ends of the adjustable suture construct to reduce a size of the first and second adjustable loops and draw the first and second bone portions toward each other under a first tension includes drawing the first and second bone portions of a different bone toward each other.

35. A method for applying tension to a flexible member, comprising:

positioning a tensioning member in a first position relative to a first bone portion and a second bone portion, the tensioning member having first and second flexible member attachment members;

positioning the flexible member about the first and second bone portions;

coupling the flexible member to the first and second attachment members;

tensioning the flexible member to draw the first and second bone portions toward each other under a first tension;

rotating the tensioning member to a second position such that the first and second attachment members draw first and second ends of the flexible member in opposite directions applying additional tension to the flexible member to place the flexible member and the first and second bone portions under a second tension; and

securing the tensioning member in the second position to at least one of the first and second bone portions to maintain the second tension.

36. The method of claim 35, wherein positioning the flexible member about the first and second bone portions includes wrapping the flexible member around the first and second bone portions.

37. The method of claim 35, wherein coupling the flexible member to the first and second attachment members includes coupling a first adjustable loop of an adjustable suture construct formed from a suture to a first post and coupling a second adjustable loop of the adjustable suture construct to a second post, the first and second adjustable loops extending from a passage portion of the adjustable suture construct.

38. The method of claim 35, wherein tensioning the flexible member to draw the first and second bone portions toward each other under the first tension includes tensioning the flexible member relative to the first and second attachment members.

39. The method of claim 35, wherein securing the tensioning member in the second position to at least one of the first and second bone portions includes securing the tensioning member to at least one of the first and second bone portions with at least one bone screw.

40. The method of claim 35, wherein securing the tensioning member in the second position to at least one of the first and second bone portions includes securing the tensioning member to the first and second bone portions such that the tensioning member is positioned over a fracture between the first and second bone portions and at least one bone screw is positioned through the tensioning member and into each of the first and second bone portions.

41. The method of claim 35, wherein positioning the tensioning member in the first position relative to the first bone portion and the second bone portion includes positioning the tensioning member having a body with an I-shape in the first position relative to the first bone portion and the second bone portion.

42. The method of claim 41, wherein securing the tensioning member in the second position to at least one of the first and second bone portions to maintain the second tension includes positioning bone screws through end portions of the I-shaped body that are positioned perpendicular to a central portion of the I-shaped body.

43. The method of claim 35, further comprising rotatably coupling the tensioning member to one of the first and second bone portions to form a pivot point;

and

wherein rotating the tensioning member to the second position such that the first and second attachment members draw first and second ends of the flexible member in opposite directions includes rotating the tensioning member about the pivot point.

44. The method of claim 43, wherein rotatably coupling the tensioning member to one of the first and second bone portions includes rotatably coupling the tensioning member to one of the first and second bone portions with a bone screw.

45. An apparatus for applying tension to a suture, comprising:

a tensioning member assembly including;

a first member having a body defining a first bone engaging surface, an opposite second surface, and a pocket formed in the second surface and extending toward the first surface, the pocket including a first retention arrangement; and

a second member sized and shaped to be received in the pocket, the second member including a first lower surface and a second upper surface, the second upper surface including first and second suture attachment members spaced apart from each other, the first and second suture attachment members adapted to be coupled to the suture, the second member configured to be positioned at least partially into the pocket and including a second retention arrangement operable to engage the first retention arrangement;

wherein the second member is configured to be rotated relative to the first member to impart tension onto the suture, and wherein the first retention arrangement is configured to engage the second retention arrangement to prevent rotation of the second member relative to the first member in at least one rotational direction.

46. The apparatus of claim 45, wherein the pocket includes a sidewall having a circular shape, and the second member includes an outer perimeter having a circular shape and a second diameter sized to be complimentary to a first diameter of the pocket.

47. The apparatus of claim 46, wherein the first retention arrangement includes a first spline configuration on the sidewall of the pocket, and the second retention arrangement includes a complimentary second spline configuration on the outer perimeter of the second member.

48. The apparatus of claim 46, wherein the sidewall of the pocket includes a first or lower end adjacent to a floor of the pocket and a second or upper end adjacent to the second surface, the first spline configuration extending along a first portion of the sidewall from the first end partially toward the second end such that a second portion of the sidewall extending from the first portion to the second end is not splined.

49. The apparatus of claim 48, wherein the second member is configured to be received in the pocket in a first position whereby the outer perimeter is positioned along the second portion of the sidewall such that the second member can be rotated relative to the first member to impart tension onto the suture while being guided by the pocket, and then further inserted into the pocket to a second position where the second spline configuration engages the first spline configuration on the first portion of the sidewall to prevent rotation of the second member relative to the first member.

50. The apparatus of claim 46, wherein the first retention arrangement includes a plurality of first ramped members positioned on a floor of the pocket, each of the first ramped members including a first inclined surface and a first end face, and wherein the second retention arrangement includes a plurality of second ramped members positioned on the first lower surface of the second member, each of the second ramped members including a second inclined surface and a second end face.

51. The apparatus of claim 50, wherein upon positioning the second member in the pocket, the plurality of first ramped members are configured to cooperate with the plurality of second ramped members to allow rotation of the second member relative to the first member in a first direction to impart tension onto the suture and to prevent rotation in a second opposite direction to maintain the tension on the suture.

52. The apparatus of claim 51, wherein the first and second inclined surfaces are configured to cooperate with each other to allow rotation in the first direction, and wherein the first and second end faces are configured to cooperate with each other to prevent rotation in the second direction.

53. A method for applying tension to a flexible member, comprising:

positioning a first member of a tensioning member assembly relative to a first bone portion and a second bone portion, the tensioning member including a pocket formed therein on an upper surface opposite a lower bone engaging surface;

positioning the flexible member about the first and second bone portions;

coupling the flexible member to first and second attachment members associated with a second member of the tensioning member assembly;

rotating the second member in a first rotational direction relative to the pocket of the first member to impart tension onto the flexible member; and

positioning the second member in the pocket of the first member such that a second retention arrangement associated with the second member engages a first retention arrangement associated with the pocket of the first member to prevent rotation of the second member relative to the first member in a second rotational direction opposite the first rotational direction to maintain the tension imparted onto the flexible member.

54. The method of claim 53, further comprising securing the first member to at least one of the first and second bone portions prior to rotating the second member.

55. The method of claim 53, further comprising positioning the second member in the pocket of the first member prior to rotating the second member.

56. The method of claim 53, wherein preventing rotation of the second member in the second rotational direction includes engaging a second retention arrangement on a lower side of the first member with a first retention arrangement on a floor of the pocket of the first member.

57. The method of claim 53, further comprising:

positioning the second member partially into the pocket of the first member to a first position such that the second member can be rotated relative to the pocket, wherein rotating the second member includes rotating the second member in the first position; and

positioning the second member further into the pocket to a second position where the second retention arrangement associated with the second member engages the first retention arrangement associated with the pocket of the first member.

58. The method of claim 57, wherein the first retention arrangement includes a first spline configuration associated with a portion of a sidewall of the pocket, and the second retention arrangement includes a second spline configuration associated with a perimeter of the second member.