Method and Apparatus for Sternal Closure

• US 20110106153A1
• Filed: 11/03/2010
• Published: 05/05/2011
• 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: Wagner, Zachary, Berelsman, Brian K., Stone, Kevin T.
• Granted Patent: US 8,597,327 B2
• Time in Patent Office: Days
• US Class Current: 606/228
• 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 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• 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 17/823 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 2017/0404 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

A method and apparatus for securing a fractured or sectioned sternum in a patient'"'"'s body is disclosed. The apparatus can include an attachment member and an adjustable flexible member construct. The attachment member can have a flexible member holder. The adjustable flexible member construct can have first and second ends and a body defining at least one passage portion. The first and second ends can be passed into and through the at least one passage portion via first and second openings associated with the at least one passage portion of the adjustable flexible member construct to form a pair of loops. The attachment member can be configured to be coupled to at least one of the formed pair of loops. The adjustable flexible member construct can be positioned about the sternum and can be reduced to compress the fractured or sectioned sternum.

Claims

1. An apparatus for securing a fractured or sectioned sternum in a patient'"'"'s body, comprising:

an attachment member having a flexible member holder; and

an adjustable flexible member construct having a body extending from a first end to a second end and defining at least one passage portion, the first and second ends being passed into and through the at least one passage portion via at least first and second openings associated with the at least one passage portion of the adjustable flexible member construct to form a pair of loops;

wherein the attachment member is configured to be coupled to at least one of the formed pair of loops.

2. The apparatus of claim 1, wherein the at least one passage portion includes first and second passage portions each having at least the first and second openings and spaced apart from each other by a first portion of the adjustable flexible member construct, the first end being passed into and through the second passage portion and then into and through the first passage portion to form a first adjustable loop of the pair of loops, the second end being passed though the first passage portion and then through the second passage portion to form a second adjustable loop of the pair of loops, the first and second loops having a first side adjacent the first portion and a second side opposite the first portion.

3. The apparatus of claim 2, wherein the first and second ends are passed through both the first passage portion in opposite directions and the second passage portion in opposite directions.

4. The apparatus of claim 3, wherein the first end is passed through the second passage portion from the first opening to the second opening thereof and is passed through the first passage portion from second opening to the first opening thereof;

and

wherein the second end is passed through the first passage portion from the first opening to the second opening thereof and is passed through the second passage portion from second opening to the first opening thereof.

5. The apparatus of claim 3, wherein the first and second ends are moveable relative to the first and second passage portions such that the first and second loops can be adjusted in size relative to the first and second passage portions.

6. The apparatus of claim 3, wherein the first portion is fixed in length between the first and second passage portions.

7. The apparatus of claim 1, wherein the adjustable flexible member construct comprises a suture formed of a braided or woven structure.

8. The apparatus of claim 2, wherein the attachment member includes a first portion and a second portion positioned substantially perpendicular to the first portion to form a generally T-shaped configuration;

and wherein the flexible member holder includes an aperture formed in the first portion proximate an end opposite the second portion.

9. The apparatus of claim 8, wherein the first and second loops are passed through the aperture of the attachment member to slidably couple the attachment member thereto.

10. The apparatus of claim 2, further comprising a passing member detachably coupled to the first portion.

11. The apparatus of claim 2, further comprising a tensioning member removably coupled to the first and second ends of the adjustable flexible member construct.

13. The apparatus of claim 1, wherein the attachment member comprises a pair of attachment members having a substantially arcuate configuration and including an aperture at one end thereof, each of the attachment members coupled to a respective loop of the pair of loops.

14. The apparatus of claim 1, wherein the attachment member includes a frame having flexible member attachment portions at opposite ends thereof, the attachment portions are each configured to secure a respective loop of the pair of loops.

15. The apparatus of claim 14, wherein the frame further comprises a channel extending along a length of the frame and between the pair of attachment portions, the channel configured to receive the at least one passage portion therein.

16. The apparatus of claim 1, wherein the attachment member includes a frame having a lower surface and an opposite upper surface, the upper surface including a post extending therefrom, the post having a base portion coupled to the upper surface and a head portion coupled to the base portion and having a larger width than the base portion;

and

wherein the post is configured to secure the pair of loops thereto.

17. A method for securing a fractured or sectioned sternum in a patient'"'"'s body, comprising:

forming an adjustable flexible member construct including;

providing a flexible member having first and second ends and a body defining first and second passage portions spaced apart from each other by a first portion of the flexible member;

passing the first end into and through the second passage portion and then into and through the first passage portion to form a first loop;

passing the second end into and through the first passage portion in an opposite direction as the first end and then into and through the second passage portion in an opposite direction as the first end to form a second loop; and

coupling an attachment member to the first and second loops;

encircling the fractured or sectioned sternum by at least partially wrapping the formed adjustable flexible member construct about the sternum;

coupling the first portion of the adjustable flexible member construct opposite the loops to the attachment member; and

reducing the adjustable flexible member construct to compress the fractured or sectioned sternum.

18. The method of claim 17, wherein reducing the adjustable flexible member construct to compress the fractured or sectioned sternum comprises applying tension to the first and second ends of the adjustable flexible member construct such that a size of the first and second loops is decreased thereby compressing the fractured or sectioned sternum;

and wherein the adjustable flexible member construct automatically remains in a reduced position about the sternum.

19. The method of claim 18, further comprising:

forming first and second pairs of holes through a manubrium of the sternum, each pair of holes being on opposed sides of a section or fracture of the sternum;

wherein forming a flexible member construct includes forming a plurality of flexible member constructs;

passing a first flexible member construct of the plurality of formed flexible member constructs through the first pair of holes and a second flexible member construct of the plurality of formed flexible member constructs through the second pair of holes such that the attachment members and passing portions of the first and second flexible member constructs are on an anterior side of the sternum;

coupling first portion of the first and second flexible member constructs opposite the loops to their respective attachment members; and

reducing the first and second constructs to compress the fractured or sectioned sternum.

20. The method of claim 19, further comprising passing the first and second flexible member constructs through the first and second pairs of holes such that the first and second constructs overlap each other so as to form an X-shaped pattern.

21. The method of claim 19, further comprising:

encircling the sternum with a third flexible member construct of the plurality of formed flexible member constructs adjacent an intercostal space;

coupling the first portion of the third flexible member construct opposite the loops to its respective attachment member; and

reducing the third adjustable flexible member construct to compress the fractured or sectioned sternum.

22. The method of claim 19, further comprising:

providing a single passage portion adjustable flexible member construct;

coupling the single passage portion adjustable flexible member construct to the first and second adjustable flexible member constructs before coupling the first portion of the first and second adjustable flexible member constructs to their respective attachment members; and

tensioning the single passage portion adjustable flexible member construct to a reduced size after reducing the first and second constructs to reduce the fractured or sectioned sternum, the single passage portion adjustable flexible member construct automatically maintaining the reduced size.

23. The method of claim 22, wherein the single passage portion adjustable flexible member construct is orientated substantially perpendicular to the first and second adjustable flexible member constructs.

24. The method of claim 17, wherein encircling the fractured or sectioned sternum further comprises passing the adjustable flexible member construct around the posterior side of the sternum with a needle passing member detachably coupled to the first portion of the adjustable flexible member construct.

25. The method of claim 17, wherein forming an adjustable flexible member construct includes coupling the first and second ends to a tensioning member;

and

wherein reducing the adjustable flexible member construct to compress the fractured or sectioned sternum includes engaging the tensioning member to simultaneously decrease a size of the first and second loops to compress the fractured or sectioned sternum.

26. The method of claim 17, further comprising applying an orthopedic mesh to at least an anterior side of the fractured or sectioned sternum such that at least a portion of the adjustable flexible member construct rests on the orthopedic mesh.

27. The method of claim 26, further comprising applying a platelet concentrate, antibiotic concentrate, or combinations thereof, to the adjustable flexible member construct, the orthopedic mesh, or combinations thereof.

28. A method for securing a fractured or sectioned sternum in a patient'"'"'s body, comprising:

providing an adjustable flexible member construct having first and second ends and a body defining at least one passage portion therebetween, the first and second ends being passed into and through the at least one passage portion via at least first and second apertures associated with the at least one passage portion of the adjustable flexible member construct to form a pair of loops;

positioning the adjustable flexible member construct across a fracture or section of the fractured or sectioned sternum;

providing a fixation arrangement;

coupling the pair of loops to the fixation arrangement;

reducing the adjustable flexible member construct to a reduced position to compress the fractured or sectioned sternum by applying tension to the first and second ends of the adjustable flexible member construct and thereby reducing a size of the pair of loops; and

automatically maintaining the adjustable flexible member construct in the reduced position.

29. The method of claim 28, wherein providing a fixation arrangement includes providing first and second attachment members each having a C-channel configuration;

wherein coupling the pair of loops to the fixation arrangement includes coupling one loop of the pair of loops to the first attachment member and the other loop to the second attachment member; and

wherein reducing the flexible member construct further comprises positioning the first and second attachment members about opposed lateral sides of the fractured or sectioned sternum such that the adjustable flexible member construct spans the fracture or section.

30. The method of claim 28, further comprising forming a bore through the sternum extending from a medial side to a lateral side thereof;

and

positioning the flexible member construct through the bore such that the at least one passage portion is positioned within the bore;

wherein providing a fixation arrangement includes providing a pair of flexible anchors and wherein coupling the fixation arrangement to the pair of loops includes coupling each flexible anchor of the pair of flexible anchors to a respective loop of the pair of loops;

wherein reducing the adjustable flexible member construct further comprises positioning the flexible anchors coupled to the respective loops outside the bore and relative to the medial and lateral sides of the sternum.

31. The method of claim 30, further comprising applying an orthopedic mesh about at least a portion of the anterior and medial and lateral sides of the sternum;

and

passing the adjustable flexible member construct through the orthopedic mesh such that the orthopedic mesh is between each flexible anchor and the respective medial and lateral sides of the sternum.

32. The method of claim 28, wherein providing a fixation arrangement comprises providing a frame having first and second attachment portions positioned about opposed ends of the frame, and positioning the frame about an anterior side of the sternum;

and

wherein coupling the pair of loops to the fixation arrangement includes coupling one loop of the pair of loops to the first attachment portion, passing the adjustable flexible member construct around a posterior side of the sternum, and coupling another loop of the pair of loops to the second attachment portion.

33. The method of claim 28, wherein providing a fixation arrangement comprises providing a frame having first and second attachment portions positioned about opposed ends of the frame and a channel extending across a top surface of the frame between the opposed ends, and positioning the frame about an anterior side of the sternum;

and

wherein coupling the pair of loops to the fixation arrangement includes positioning the at least one passing portion in the channel, wrapping a first loop of the pair of loops around a posterior side of the sternum in a first direction and coupling the first loop to the first attachment portion, and wrapping a second loop of the pair of loops around the posterior side of the sternum in a second direction opposite the first direction and coupling the second loop to the second attachment portion.

34. The method of claim 28, further comprising:

providing first and second separate loops;

positioning the first and second loops laterally about a posterior side of the sternum such that respective opposed ends of each loop extend to an anterior side of the sternum;

providing a fixation arrangement that includes four attachment members each having an aperture formed therein, and wherein coupling the fixation arrangement to the pair of loops includes integrally coupling each of the four attachment members to the pair of loops of the adjustable flexible member construct; and

coupling the opposed ends of the first loop to two of the four attachment members that are positioned relative to respective medial and lateral sides of the sternum, and coupling the opposed ends of the second loop to another two of the four attachment members that are positioned relative to the respective medial and lateral sides of the sternum.

35. The method of claim 34, wherein the first and second loops each include an adjustable loop or a continuous fixed loop, the first and second loops are spaced apart from each other and are each positioned around the posterior side of the sternum relative to different intercostal spaces.