Sternal closure method and system

• US 10,639,084 B2
• Filed: 11/13/2019
• Issued: 05/05/2020
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Zimmer Biomet CMF and Thoracic, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Biomet CMF and Thoracic, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Garcia, Saddy, Wilcox, Bryan, Witten, Benjamin
• Primary Examiner(s): Sevilla, Christian A
• Application Number:
  US16/682,775
• Publication Number:
  US 20200078063A1
• Time in Patent Office: 174 Days
• CPC Class Codes: A61B 17/0466 Suture bridges
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/1606 of forceps type, i.e. having two jaw elements moving relative to each other
• CPC Class Codes: A61B 17/1611 the two jaw elements being integral with respective elongate shaft elements
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1728 for holes for bone plates or plate screws
• CPC Class Codes: A61B 17/1789 for the sternum
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• 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 17/7053 with parts attached to bones or to each other by flexible wires, straps, sutures or cables
• CPC Class Codes: A61B 17/8076 for the ribs or the sternum
• CPC Class Codes: A61B 17/808 Instruments for holding or positioning bone plates, or for adjusting screw-to-plate locking mechanisms
• 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 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8861 : Apparatus for manipulating flexible wires or straps devices for inserting Kirschner wires A61B17/1697
• CPC Class Codes: A61B 17/8869 : Tensioning devices
• CPC Class Codes: A61B 2017/00734 : battery operated
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06038 : soldered or brazed or welded for connecting prosthetic parts A61F2002/30451, A61F2220/0058
• CPC Class Codes: A61B 2017/06057 : Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06071 : with an abrupt angle formed between two adjacent sections
• CPC Class Codes: A61B 2017/0608 : J-shaped
• CPC Class Codes: A61B 2017/06104 : interconnected at their distal ends, e.g. two hollow needles forming a loop for passing a suture
• CPC Class Codes: A61B 2017/0619 : thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it suture cutters A61B17/0467; ultrasonic cutters A61B17/320068; electrically heated instruments A61B18/08

Abstract

A system including a bone punch tool and a needle guide. The bone punch tool can include a support arm having a support arm proximal portion and a support arm distal portion, a pivot arm having a pivot arm proximal portion and a pivot arm distal portion, and an arcuate punch configured to punch through bone. The pivot arm distal portion can be pivotably coupled to the support arm distal portion, such that the pivot arm proximal portion is configured to be moved away from the support arm proximal portion to extend the arcuate punch into a punch position to punch an arcuate hole through bone. The needle guide can be configured to guide a needle through the arcuate hole.

Claims

1. A method of closing a severed sternum, the method comprising:

providing or receiving a plate having plate apertures sized to receive a fastener;

providing or receiving a guide unit having tubular-shaped fastener guides sized to releasably hold the fastener, each of the fastener guides having a proximal opening for loading the fastener and a distal opening for discharging the fastener;

providing or receiving the fastener for each of the fastener guides;

positioning the plate over a first sternal bone portion and a second sternal bone portion;

positioning the guide unit over the plate such that the distal opening of each of the fastener guides is aligned with a corresponding one of the plate apertures;

driving each fastener out of the guide unit and tubular-shaped fastener guides and into plate apertures and at least one of the first sternal bone portion and the second sternal bone portion; and

withdrawing the guide unit from the plate,

wherein an outer peripheral shape of the guide unit corresponds to an outer peripheral shape of the plate.

2. The method of claim 1, further comprising moving the first sternal bone portion towards the second sternal bone portion so as to reapproximate sides of the severed sternum.

3. The method of claim 1, further comprising loading fasteners into the guide unit prior to positioning the guide unit over the plate.

4. The method of claim 1, wherein the fastener guides have a slit extending from the proximal opening down toward the distal opening.

5. The method of claim 1, wherein the plate apertures are circular and the fasteners are screws.

6. The method of claim 1, further comprising:

providing or receiving a cerclage;

wrapping the cerclage around at least a portion of each of the first and second sternal bone portions.

7. The method of claim 6, wherein placing the bracket comprises placing the bracket over or adjacent the cerclage.

8. The method of claim 6, further comprising:

tensioning the cerclage to secure the first sternal bone portion to the second sternal bone portion.

9. The method of claim 6, wherein the cerclage is a band formed of metallic or polymeric material.

10. The method of claim 6, wherein two ends of the cerclage are twisted together to connect the two ends together.

11. The method of claim 1, further comprising:

coupling the guide unit to the plate via mounting tabs.

12. The method of claim 11, wherein withdrawing the guide unit from the plate comprises separating the mounting tabs from the plate.

13. The method claim 1, wherein the fastener guides are positioned on a periphery of the guide unit.

14. The method of claim 1, wherein each of the plate apertures of the plate are linked to each other by a narrower neck portion between adjacent plate apertures.

15. The method of claim 1, wherein driving each fastener comprises driving a first fastener into the first sternal bone portion and then driving a second fastener into the second sternal bone portion.

16. The method of claim 1, wherein placing the bracket comprises placing the bracket such that it conforms to contours of at least one of the first and second sternal pone portions.

17. The method of claim 1, wherein positioning the guide unit over the plate comprises aligning the outer peripheral shape of the guide unit with at least a portion of the outer peripheral shape of the plate.

18. A sternal closure system, comprising:

a plate including a plurality of circular plate apertures, the plate configured to be secured to first and second sternal bone portions, and

a guide unit comprising fastener guides, wherein each of the fastener guides is a tube configured to releasably hold a fastener, the tube having a proximal opening for loading the fastener into the tube and for access by a driver and a distal opening to allow for discharging the fastener from the tube,

wherein the fastener guides are configured to be aligned with the plate apertures such that the distal opening of each tube aligns with a corresponding one of the plurality of circular plate apertures,

wherein an outer peripheral shape of the guide unit corresponds to an outer peripheral shape of the plate,

wherein the fastener is configured to be driven into a plate aperture of the plurality of plate apertures and into at least one of the first sternal bone portion or the second sternal bone portion, and

wherein the tube has a slit extending from the proximal opening down at least a portion of the tube.

19. The closure system of claim 18, wherein the fastener guides are positioned on a periphery of the guide unit.

20. The closure system of claim 18, wherein the guide unit includes mounting tabs configured to couple the guide unit to the plate.

21. The closure system of claim 18, wherein the plate is configured to conform to contours of at least one of the first and second sternal bone portions.

22. The closure system of claim 18, further comprising:

a cerclage configured to be wrapped around at least a portion of each of the first and second sternal bone portions.

23. The closure system of claim 22, wherein the plate is structured to allow the cerclage to extend beneath the plate.

24. The closure system of claim 18, wherein the plate includes a body and a plurality of feet extending from the body, wherein a bottom surface of the body is raised relative to a bottom surface of at least one foot of the plurality of feet.

25. The closure system of claim 18, wherein each of the plate apertures of the plate are linked to each other by a narrower neck portion between adjacent plate apertures.