WO2016036800A1

WO2016036800A1 - Sternal realignment system and method

Info

Publication number: WO2016036800A1
Application number: PCT/US2015/048057
Authority: WO
Inventors: Peter D. Winch; William Ray; Jeremy Patterson; Robert Strouse
Original assignee: Nationwide Childrens Hospital Inc
Current assignee: Nationwide Childrens Hospital Inc
Priority date: 2014-09-04
Filing date: 2015-09-02
Publication date: 2016-03-10
Anticipated expiration: 2017-03-04

Abstract

Systems, apparatuses and methods for aligning sections of a sternal bone are described herein. One example includes a frame supported by a plurality of generally longitudinal and lateral rails, A clamping fixture is secured to at least a portion of one of the rails, and a selectively moveable guide block is movably supported by the lateral rails. The guide block comprises a plurality of drill openings substantially parallel to the lateral rails for creating sagittal openings in sections of a sternal bone during use. Another example Includes a longitudinal alignment apparatus comprising a frame having first and second sides that support a plurality of rings with respective inner portions that are anchored to the sternal bone, A guide arrangement having a supporting member is positioned onto the plurality of inner portions, A slider apparatus, an aperture for receiving a drilling device, is inserted into the supporting member.

Description

TITLE: STER AL REALIGNMENT SYSTEMS AND METHODS

CROSS REFERENCES TO RELATED APPLICATIONS

0 f I The following application cla ms priority under 35 U.S.C. § 1 19(c) to copending U.S. Provisional Patent Application Serial No. 62/045,944 filed September 4, 2014 entitled STERNAL REALIGNMENT SYSTEM. AND METHOD. The above-identified application is incorporated herein by reference in its entirety for ail purposes.

TECHNICAL FIELD

[Θ 02] The present disclosure relates generally to a sternal realignment system, and more specifically, to a sterna! realignment apparatus and method of operation relating to the performance of a sternotomy that is believed to improve recovery time and increase general bone alignment, while reducing the risk of infection and wound dehiscence.

BACKGROUND ΘΘΘ3] Operations are frequently performed via a median sternotomy in order to expose the heart, lungs or other major vascular structures. This involves longitudinally sawing through the sternal bone and allowing the sternum to articulate at the margin with the rrst seven (7) ribs. At the conclusion of the operation, the sternum is closed and its original alignment typically approximated using heavy gauge wires, colloquially known as "wiring the chest". The wires provide a degree of stability to the sternum while the bone is healing din n the recovery period, typically eight (8) weeks, Since the sternum protects vital organs, a well healed sternum is essential for human health and survival.

[0004] Typically, many conventional sternal realignment methods also involve wires pulled together to approximate the original bone location. However, perfect realignment is rarely, if ever, assured. Indeed, the anterior/posterior stability of a sternum that has beers wired together often is very minimal. ¾ addition, obese patients pl ee considerable traction on the sternal wires, and the wires, under such traction, can. effectively saw through the ^'bone. Wound breakdown or dehiscence and sterna infection are potential risks with conventional reconstruction techniques from a sternotomy and are of serious clinical concern. A poorly approximated sternum will further cause pain with respiration; resulting in a decrease in tidal volumes, which can lead to pneumonia.

SUMMARY

[Θ005] One example embodiment of the present disclosure includes an apparatus and method for aligning sections of a sternal bone that includes a frame supported by a plurality of generally longitudinal and lateral rails. The apparatus further comprises a clamping fixture secured to at least a portion of one of the rails, and a selectively moveable guide block that is movabiy supported by the lateral rails. The guide block comprises a plurality of drill openings substantially parallel to the lateral rails for creating sagittal openings in sections of ·¾ sternal bone during use.

|Θ0Θ6| Another example embodiment of the present disclosure includes a method for aligning sections of a sternal bone, She method comprises the steps of inserting an alignment apparatus having a frame supported by a plurality of generally longitudinal and lateral rails, securing at least one clamping fixture that is fixedly attached to at least a portion of one of the longitudinal rails or the lateral rails to the sternal bone with a fastener that is adjustably attached to the clamping fixture, moving a guide block that is movabiy supported by the lateral rails, the guide block comprising a plurality of drill openings substantially parallel to the lateral rails, and drilling a plurality of sagittal openings through the drill openings in sections of a sternal bone, [O607J A further example embodiment of the present, disclosure includes a system for aligning sections of a sternal bone. The system comprises a longitudinal alignment apparatus comprising a frame having first and second sides, said first and second sides supporting a plurality of rings; said rings having respective inner portion anchored by a fastener during use to the sternal bone; a guide arrangement for positioning onto the plurality of inner portions of said rings once anchored by fasteners to the sternal bone, me guide arrangement having a supporting member; and a slider apparatus for insertion into said supporting member of said guide arrangement, wherein said slider apparatus comprises an aperture for receiving a drilling device.

[0008] Yet another example embodiment of the present disclosure includes a method for substantially symmetrically aligning sections of a sternal bone. The method comprising the steps of: placing a longitudinal alignment apparatus on a patient's sternal bone, the longitudinal alignment apparatus comprising first and second sides; securing a plurality of alignment inner portions that are removably attached to the longitudinal alignment apparatus into the patient's sternal bone; removing at least a portion of the longitudinal alignment apparatus from the patient's sternal bone, while leaving the alignment inner portions secured to the sternal bone; placing a guide arrangement onto the plurality of alignment. Inner portions on sectioned sides of the patient's sternal bone; inserting a slider apparatus into each side of the guide arrangement, wherein said slider apparatus comprises an opening for receiving a drilling device; and drilling a plurality of openings in sections of a sternal bone through the openings.

BRIEF DESCRIPTION OF THE DRAWINGS CI09| The foregoing and other features and advantages of the present disclosure will become apparent^' to one skilled in the art to which the present disclosure relates upon consideration of the following description of the invention with reference to the accompanying drawings, wherein like reference numerals, unless otherwise described refer to like parte throughout the drawings and in which:

fCK!!f!] FIG, 1 is a front elevation view of a sternum applied with guide markings in accordance with one example embodiment of the present disclosure;

FIG. 2 is a front elevation view of a sternal aligni-aent apparatus positioned during a medial sternotomy for realignment In accordance with one example embodiment of the present disclosure;

0012J FIG, 3 is a perspective view of FIG. 2;

|ΘΘΙ3] FIG. 4 is sternum positioned for realignment subsequent to the procedure performed by the sternal realignment apparatus in accordance with one example embodiment of the present disclosure;

[0014] FIG. 5 is a first perspective view of a sternal realignment apparatus with a guide block located at a first position, the sternal realignment apparatus constructed in accordance with one example embodiment of the present disclosure;

| 1S| FIG. 6 is a second perspective view of a sternal realignment apparatus with a guide block located at a second position, the sternal realignment apparatus constructed in accordance with one example embodiment of the present disclosure;

[CM! 1.6] FIG. 7 is a front elevation view of FIG. 5;

f§0!7] FIG. 8 is an end view of the sternal realignment apparatus constructed i accordance with one example embodiment of the present disclosure; and

ffM!iS] FIG. 9 is a side view of the sternal realignment apparatus constructed in accordance with one example embodiment of the present disclosure.

[0019] FIG. 10 is a front elevation view of a sternum with a longitudinal alignment apparatus, in an embodiment having one supporting member, applied to the sternal bone. [0020] FIG, 1 ! is a front elevation view of the sternum wife inner portions of the longitudinal apparatus secured to the sternal bone, while the rest of the longitudinal apparatus is removed,

[0021] FIG. 12 is a front elevation view of the left side of the sternum after surgical opening with inner portions of the longitudinal apparatus secured thereto.

[0Θ22] FIG. 13 is a front elevation vie of the right side of the sternum after surgical opening with inner portions of the longitudinal apparatus secured thereto.

[0023] FIG. 14 is a front elevation view of the sternum after the surgical opening with a guide arrangements placed onto the inner portions on each side of the sternum,

[0024] FIG. 15 is a front elevation view of the sternum after the surgical opening wife a slider apparatus inserted into a left side of a supporting member of the guide apparatus.

[0025] FIG, 36 is a front elevation view of the sternum after the surgical opening with a slider apparatus inserted into a right side of a supporting member of the guide apparatus.

[0026] FIG. 17 is a front elevation view of the sternum with a dowel inserted into one of fee holes drilled through the slider apparatus on each side,

[0027] FIG, 18 is a front elevation view of the sternum closed after surgery is complete wife the sternal alignment ensured by the embodiment of the sternal alignment system with one supporting member.

[0028] FIG. 19 is a front elevation view of a sternum with a longitudinal alignment apparatus, in an embodiment having three supporting members, applied to fee sternal bone.

[0029] FIG. 20 is a front elevation view of the sternum closed after surgery is complete with the sternal alignment ensured by the embodiment of the sternal alignment system with three supporting members.

|0030] FIG. 21 is a perspective view of the longitudinal alignment apparatus of fee sternal alignment system shown in FIG. 10. [0031] FIG, 22 is a side elevated view of the longitudinal alignment apparatus of FIG, 21.

[0032] FIG, 23 is a top view of the longitudinal alignment apparatus of FIG, 2L

[0033] FIG, 24 is a bottom view of the longitudinal alignment apparatus of FIG. 21 ,

[0034] FIG, 25 is a left view of the longitudinal alignment apparatus of FIG. 21, fDI SJ FIG. 26 is a right view of the longitudinal alignment apparatus of FIG. 21.

[0036] FIG. 27 is a perspective view of the longitudinal alignment apparatus of the sterna! alignment system shown in FIG, 19.

[0Θ37] FIG. 28 is a side elevated view of the longitudinal allotment apparatus of FIG. 27.

[0038] FIG. 29 is a top view of the longitudinal alignment apparatus of FIG. 27.

[0039] FIG. 30 is a bottom view of the longitudinal alignment apparatus of FIG. 27,

[0040] FIG. 31 is a left view of the longitudinal alignment apparatus of FIG. 27,

[0041] FIG, 32 is a right view of the longitudinal alignment apparatus of FIG. 27.

[0042] FIG. 33 is a perspective view of the guide arrangement of the sternal alignment system having one supporting member shown in FIG. 14.

[0043] FIG. 34 is a side elevated view of the guide arrangement of FIG. 33.

[Θ044] FIG, 35 is a top view of the guide arrangement of FIG. 33.

[0045] FIG. 36 is a bottom view of the guide arrangement of HO. 33 ,

[0046] FIG. 37 is a left view of trie guide arrangement of FIG. 33.

[0047] FIG, 38 is a right view ofl e guide arrangement of FIG. 33.

[0048] FIG. 39 is a perspective view of the guide arrangement of the sternal alignment system having three supporting members as shown in FIG. 19.

[0049] FIG, 40 is a side elevated view of the guide arrangement of FIG. 39. [0050] FIG. 41 Is a top view of the guide arrangement of FIG. 39.

[0051 FIG, 42 s a bottom v ew of the guide arrangement of FIG. 39.

10052] FIG. 43 is a left view of the guide arrangement of FIG. 39.

[Θ053] FIG. 44 is a right view of the guide arrangement of FIG, 39,

[CHI54J FIG,. 45 is a. perspective view of the slider apparatus for insertion into a supporting member of the guide arrangement shown in FIGS. 14 or 19,

[0055] FIG . 46 is a side elevated view of the slider apparatus shown in FIG, 45,

[ 0561 FIG. 47 is a top view of the slider apparatus shown in FIG. 45.

[0057] FIG, 48 is a bottom view of the slider apparatus shown in FIG. 45,

[0058] FIG. 49 s a left view of the slider apparatus shown in FIG. 45.

[0059} FIG. 50 is a right view of the slider apparatus shown Irs FIG. 45,

[0060] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may he exaggerated relative to other elements to help to improve understanding of embodiments of the present disclosure.

£0061] The apparatus and method components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details^' that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

DETAILED DESCRIPTION

[0062] Referring now to the figures wherein like numbered features shown therein refer to like elements throughout unless otherwise noted. The present disclosure relates generally to a sternal realignment system, and more specifically, to a sternal realignment apparatus and method of operation relating to the performance of a sternotomy that is believed to increase healing recovery time and general bone alignment, while reducing the risk of infection and wound dehiscence.

[0063] illustrated in FIG. 1 is a front elevation view of a sternum S applied with guide or pin markings A, B, and C in accordance with one example embodiment of the present disclosure, The guide markings are applied to the sternum of a patient prior to performing a sternotomy. The guide markings A, B, and C are applied by a template 5 that is placed over the sternum S before the sternotomy. The template 5 will have corresponding line openings A', B' and C" allow for the use of a writing or scribing utensil to mark guide markings A, B, and€ on the sternum.

[6Θ6 ] Section line D illustrates a sectioning line for a division of the sternum S into first SI and second 82 parts as illustrated in FIG, 2. The sectioning of the sternum along line D is accomplished by conventional methods., such as a bone saw as would be appreciated by one of skill in the art It should be appreciated that the section line D could also be applied with a utensil using the template 5 with a corresponding line D⁵. The marking lines A, S, C, and D are applied prior to the sternal division, so upon completion of the surgery, the two sections SI and S2 can be accurately realigned, which is believed to facilitate recovery time and general bone alignment, while reducing the risk of infection and wound dehiscence,

[0065] Referring now to FIGS. 2 and 3, illustrated are front elevation and perspective views of a sternal alignment apparatus 10 positioned during the medial sternotomy of sternum S. The sternal realignment apparatus 10 facilitates the realignment of sternal sections SI and S2 in accordance with one example embodiment, of the present disclosure. FIG, 4 illustrates a the sternum S positioned for realignment of sections SI and S2 subsequent to the procedure performed by the sterna! realignment apparatus I 0 in accordance wife one example embodiment of the present disclosure.

[0066] Referring now to FIGS. 5-9, various views of the sternal realignment apparatus 10 constructed in accordance with one example embodiment of the present disclosure are shown. The apparatus 10 comprises a frame 1 1 having four clamping assemblies 12, 14, 16, and 18 toner connected by a plurality of rails 20, 21, 22, and 24. In the illustrated example embodiment, the rails are inner connected with each other by welding, but it should be appreciated that other techniques are within the scope of this disclosure, such as for example connecting by the use of fasteners.

£0067] A guide block 26 is movabiy located on lateral rails 22 and 24 through apertures 27A and 27B that pass through the entire width of the block. The guide block 26 selectively translates along the lateral rails 22 and 24 during use by a medical physician, as discuss in more detail below. The guide block includes three alignment or drilling holes 28A, 28B, and 28C that pass through the block, providing an opening on the blocks first 30 and second 32 sides. Each alignment drill hole 28 includes & pressed drill bushing 34A, 34B, and 34C, allowing for accurate and substantially horizontal or transverse drilling into sagittal sections Si and S2 of the sternum S. The drill block 26 further comprises first and second ends 36, 38, respectively and a top 40 opposite a bottom 42 about the block's substantially rectangular body 44.

[0068] The sternal realignment apparatus 10 in the illustrated example embodiment is constructed from metal, for example, stainless steel However, it should be appreciated that the apparatus 10 could be constructed from other materials such as plastic and the like having similar strength without departing from the spirit and scope of the present disclosure. Moreover, in the illustrated example embodiment, the apparatus is approximately ten (10") inches in (lie longest direction, but it is contemplated that the apparatus could be larger or smaller in size. As well, in another example embodiment, the substantially rectangular guide drill block 26 is substantially nine (9") inches in length along the top 40, one (Γ) inch wide, measured by the first or second end 36, 38, and two (2") inches tall measured by the first or second side 30, 32. The width of the block 26 is such that it allows for smooth transition without racking or binding from a first drilling position 44 (see FIG. 2) to a second drilling position 46, as the block transitions in the transverse direction of arrow A.

[0069} As illustrated in FIGS. 2 and 3, the drill guide 26 is in the first drilling position 44 and located such that the second side 32 is in full contact with the section SI of the sternum S. Shown in phantom, the guide 26 is in the second drilling position 46. In this second position 46, the guide block 26 first side 30 is in Ml contact with the section S2 of the sternum S. Recesses 45A and 45B pass along the height of the guide block 26 on the first side 30 to allow for flush contact with the sterna section S2, thus avoiding projecting clamping fixtures 16 and 18, The guide block 26 is movahly transferrable between the first and second positions 44, 46, respectively along cylindrical inner connecting rails 22 and 24 as indicated by arrow A from the first, to the second position, and opposite the arrow A from the second position to the first position.

|IM 7 | In the illustrated example embodiment, the diameter of the cylindrical rails 22 and 24 are one-quarter to three-eighths of one inch (1/4-3/8") in diameter. Rails 20 and 21 although rectangular In shape share the same thickness and In another example embodiment are also cylindrical

[0071] As illustrated in FIG. 6, the cylindrical rails 22 and 24 pass through the guide block 26 and are welded along a location at first and second points 48, 50, respectively of inner connecting rail 20. Similarly, the cylindrical rails 22 and 24 pass through the guide block 26 and are welded to clamping fixtures 16 and 18. It should be appreciated mat the rails as illustrated can be secured to either the inner rails 20 and 21 or clamping fixtures 12- 18 without departing from tie spirit of the present disclosure.

I §072 J Secured at the ends of longitudinal rails 20 and 21 by welding are clamping fixtures 12, 14, 16, and 18. The clamping futures are each constructed the same and are used for securing the apparatus 10 to the respective sternal section SI and 82. in particular, each of the clamping fixtures comprise a c-shaped opening 52 for receiving the sternal section SI or S¾ fee opening is formed by upper and lower braces 54, 56, respectively connective!)-' spaced by a back member 58, as illustrated in FIGS. 6 and 8, Each upper brace 54 includes a tapped hole 62 for receiving a respective fastener 60, Examples of such fasteners include, but are not limited to set screws and socket head cap screws.

[0073] The fasteners 60 are used to draw the sternal bone section SI and S2 against the lower brace 56 in the direction of arrow B as illustrated in FIG, 8, The fasteners 60 are tightened when in the first or second positions 44, 46, such that the first or second side 30, 32 will be in flush contact with either section as the block 26 is translated along the rails 22, 24. The fasteners 60 when the drilling operation is- complete as farther described below are loosened to allow fee apparatus 10 to be removed from the sternal sections SI and S2.

1007 1 Once a patient's skin tissue is opened to reveal the sternal bone, the bone is marked with pin alignment lines A, B, and C with the template 5, as illustrated n Ft^'G. 1. The template 5 car; further be used to mark the section line D tor sectioning the sternal bone S into two pieces SI and S2 as illustrated in FIGS. 2-4. Once the sternal bone S is cut and spread apart along section line D, the sternal alignment apparatus 10 is inserted between the sections SI and 52 and the block 26 is shifted, so that the second side 32 of the block is in contact and flush, with section SI.

ff)§}7:5] Corresponding alignment block lines 64, 66. and 68 reside on the top 40 of the guide block 26 for aligning the alignment block lines with corresponding pin alignment lines A, B, and C on section SI as illustrated in FIG. 2, Once the block lines 64, 66, and 88 are aligned with matching distances from the template 5 and corresponding pin lines A, B, and C cm sternal section SI , the fasteners 60 are tightened on clamping blocks 12 and .14.

[0076J The block 26 is then translated along rails 22 and 24 so that the first side 30 of fee block 26 is in contact and flush with section 52. Corresponding alignment block lines 64, 66, and 68 that reside on the top 40 of the guide block 26 are now aligned with corresponding pin alignment lines A, B, and C on section S2 as illustrated in dashed lines in FIG. 2. Once the block lines 64, 66, and 68 are aligned with matching distances from the template 5 and corresponding pin lines A, B, and C marked on sternal section S2, the fasteners 60 are tightened on clamping blocks 16 and IS,

[0077] At this stage of the procedure, the drill guide block 26 is moveably located on rails 22 and 24, and allows the block to be located in the first position 44 flush against the sternal hone. Drilling of the dowel pilots then occurs to form a blind holes 70A, 74B and 78C corresponding to pin lines A, B_» and C as illustrated in FIG. 4, Once pilot or blind holes 70, 74, and 78 are completed by a drilling operation on section Si of the sternum (for example by a right angled drill), the guide block 26 is translated to the other side of the sternal cavity along the rails 22 and 24 to the second position 46 where the drilling process is repeated. That is, drilling of the dowel pilots occurs to form a blind holes 72A, 76B and 80C corresponding to pin lines A, B, and C as illustrated in FIG, 4, completing the pilot hole drilling operation on section S2 of the sternum,

[ 0 81 Once the drilling operation is completed on both sections SI and S2, pins 82, 84. and 86 are then added (by a press or snug-fit connection) to one of the two corresponding holes 70-80 to mate the two sections for substantially perfect realignment and the sternal bone ^connection 100 as illustrated in FIG. 1. In one example embodiment, the pins 82, 84, and 86 are formed from a bone graph or a composite material compatible with bone tissue. in mother example embodiment, the pins 82, 84, and 86 are formed from a metal, such as stainless steel, it should be appreciated that while three alignment holes are shown in the sternum, greater or fewer alignment holes and pins could be used without departing from the spirit of the present disclosure,

[0079] This sternal bone reconneetion 100 achieved by the method and apparatus 10 described above is believed to advantageously increases healing recovery time and general bone alignment, while reducing the risk of infection and wound dehiscence. The sternal bone reconneetion 100 in the finished condition resembles that of the sternal bone in FIG, 1 because of the apparatus and method described herein. Moreover, the amount of wiring with screws or fasteners required for additional securing used in conventional sternotomy is reduced or possibly eliminated.

[0080] Another embodiment of the present disclosure, as illustrated in FIGS. 10-50 relates to sternal realignment system and associated methods. The sternal realignment system and associated methods can facilitate substantially perfect realignment and reconneetion of the sternal bone. The substantially perfect realignment and reconneetion is believed to increase healing, which is further believed to shorten a patient's recovery time, reduce the risk of infection and wound dehiscence. Additionally, the sternal realignment system -and methods can reduce or eliminate die amount of wiring with screws or fasteners required during conventional sternotomy.

[0081] Illustrated in FIG, 10 is a front elevation view of a sternum S\ A longitudinal alignment apparatus 200 of the sternal realignment system is applied to the sternum S'. For example, prior to a s ernoto , the longitudinal alignment apparatus 200 can be applied to a patient's sternal bone. As shown in FIG. 10, the longitudinal alignment apparatus 200 is substantially symmetrically positioned about section line D\ [0Θ§2| The longitud ial alignment apparatus 200 includes a frame 202 having a first side 202' and a second side 202" that mirrors the first side. For example, the first side 202^* can reside on the first part ST of the sternum and the second side 202" can reside on the second part S2' of the sternum. Optionally, the longitudinal alignment apparatus 200 can have one or more supporting membe s 208 that hold the mirrored sides 202' and 202" together in a predefined pattern.

[θ§§3] In the example shown in F G. 10, the first side 202' and the second side 202" each support a plurality of rings 204, Each of the plurality of rings 204 has a respective substantially annular inner portion 206 that is selectively removable from the longitodinal alignment apparatus 200, For example, fasteners 210 are used to separate the inner portions 206 from the rest of the longitudinal alignment apparatus 200, as well as to secure the inner portions to the patient's chest (e.g., to the sternal bone),

1)0841 A shown in FIG. 10, the fasteners are screws 2 0 (e.g., surgical screws, set screws, socket head cap screws, etc.), but other types of fasteners can be used within the scope of this disclosure. The fasteners can he constructed at least in part of a biocompatible material and can have a diameter sufficient to hold the inner portions 206 to the sternal bone through the rings 204 and, similarly, facilitate removal of the rings and frame 202 from the inner portion, in one example, the fasteners are 3.0 mm internal titanium surgical screws, 10 85) The rings 204 and frame 202 of the longitudinal alignment apparatus 200 are removed from the sternum S'„ while leaving the inner portions 206 secured to the sternal bone by the plurality of teeners 210. The rings 204 and frame 202 reassure the inner portions 206 are symmetrically positioned and aligned in a mirror-like image between both the first SI and second S2 parts when the frame and rings are removed.

[0086] In the illustrated example embodiment, the inner portions 206 are heid in position in all dimensions by the fasteners 210 (e.g., threaded by the fasteners) while the rest of the longitudinal alignment apparatus 200 is removed. FIG. 11 shows the sternum (S ) with the- inner portions 206 secured Into the sterna! bone by the plurality of fasteners 210, The sternum S' is surgically opened after the ner portions 206 are secured. For example, in a medial sternotomy procedure, (he sternum S' can be sectioned along line IT and split into the first part SP and the second part S2\ The sectioning is accomplished by conventional methods, such as using a bone saw or other appropriate methods as would be appreciated by one of skill in the art.

[0087] The inner portions 206 act as placement guides in all directions on either side SP, S2' of the surgically opened sternum, as shown in FIGS. 12-13. Stated another way, the inner portions are equally aligned on both sides of the sternum based on the construction even when the sternum .has been separated.

[0088] As shown in FIG. 14, a guide arrangement 220^s and 220" is placed onto the inner portions 206, one per sectioned side SP, S2' of the sternum. For example, the guide arrangement 220^* and 220" is constructed of two separate, but equivalent or mirror imaged parts that are attached to the inner portions 206 (or the fasteners 210 anchoring the inner portions) on each of the sectioned sides SI 82' of the sternum S\ Accordingly, each side of the guide arrangement 220' and 220" is positioned such that the guide arrangement would line up on both sides SP, S2' if the sternum were closed. The guide arrangement 220" and 220" includes a plurality of portions 222 (e.g., cups) that can overlay each of the inner portions 206, in the illustrated example embodiment, the cups 222 are snug or press-fit onto the inner portions 206,

[0089] in one example, the inner portions 206 include a recess or are counter-sunk for seating the fasteners 210 so that they are flush with an outer-most extremity of the inner portion. The guide arrangement 220' and 220" has a plurality of cups that are designed to overlay the inner portions 206. The fasteners 210 being flush allows a respective "cap" portion of the guide arrangement 220' and 220" to nest on the inner portion 206 without interference.

[0G90J The guide arrangement 220^s and 220" also includes one or more supporting members 224 thai support and anchor the cup portions 222 that o verlay the inner portions 206. The one or more supporting members 224 can also facilitate drilling holes on either side SI ', S2^! of the sternum S\ For example, the one or more supporting members 224 can be configured to accept the insertion of a slider apparatus 230, as shown in. FIGS. 15-16. In other words, the one or more supporting members 224 include one or more portions configured to mate with a portion of the slider apparatus 230. In the example shown in FIGS. 15-1.6, the one or more supporting members 224 can have one or more female connectors or openings 240 to receive or mate with guides 234 located on each slider apparatus 23(1 The mating is sufficient to secure the slider apparatus 230 within the supporting member 224.

[0091] Upon mating with the respective connector, the slider apparatus 230 overhangs from the guide arrangement 220' or 220" and into the sternum cavity in a direction substantially perpendicular to the guide arrangement The slider apparatus 230 can include a drill guide portion 232 including an opening (e.g., an alignment or drilling hole or aperture) to receive a drilling device. The opening is positioned on the slider apparatus 230 to allow for accurate and substantially horizontal or transverse drilling into sagittal sections SI' and S2' of the sternum S\ in other words, a drill bit is positioned in the same horizontal location for both sides of the sternum S' so that drill holes on each section SI S2' match to facilitate substantially symmetrical closure of the sternum. In the illustrated example embodiment, a dowel pin 250 is inserted within the holes 248, as shown in FIG. 17 to facilitate aligned closing with the application of side forces F.

[0(192] Once the drilling operation is completed on each section 81*, S2', the sternum S^* can be closed, as shown in FIG. 18. In the example shown in FIG. 18, at least portion of the system is not removed until after closure of the sternum S*. In other examples, after the holes 248 are drilled, a portion of the system (e,g,_s the guide arrangement 220' and 220" and/or the fasteners 210 and/or the inner portions 206) can be removed from the sternum S'. The sternal realignment system can provide a substantially perfect realignment and sternal bone reconnection. In the illustrated example embodiments, one or more closure devices 250 (e.g., a pin) can be added (e.g., by a press or snug-fit correction) to the holes 248 on both of the two sections SP or S2' to facilitate a mating of the sections. The pins, in one example, are termed from a bone graph or a composite material compatible with bone tissue. In another example embodiment, the pins are formed from a biocompatible metal, such as stainless steel. It should be appreciated that greater or fewer alignment holes and pins could be used without departing from the spirit of the present disclosure.

[1)093] An alternate example embodiment of the sternal realignment system is shown in FIGS. 1 and 20, In the illustrated embodiment, longitudinal alignment apparatus 300 {of FIG. 19) has three supporting members 302, 304, 306 and the guide apparatus 310 (shown in FIG. 20) has three supporting members 312, 314, 316 on each side, which correspond to the three supporting members of the longitudinal alignment apparatus, The functionality of this embodiment is similar to the functionality described with respect to FIGS. 10-18, but larger In scale for varying sized patients.

[0094] Referring now to FIGS..21-26, illustrated are various views of the longitudinal alignment apparatus 200 with one supporting member 208. The longitudinal alignment apparatus 200 includes a frame 202 having eight rings 204 (four on either side of the supporting member) on each longitudinal side. The frame can include a greater number or a fewer number of rings in each side of the supporting member. Within, each of the rings is a removable inner portion 206. The removable inner portion 206 provides a guidance that facilitates the realignment of the sternal sections SI' and S2^* subsequent to a surgical procedure that opens the sternum. FIGS. 27-32 show an alternate embodiment of the longitudinal alignment apparatus 300 with three supporting members 302, 304, 306 and a different number of rings surrounding the supporting members. In either embodiment, the longitudinal alignment apparatus 200, 300 is constructed from metal, for example, stainless steel, a polymer/plastic, or a combination of a metal and polymer/plastic. Moreover, the longitudinal alignment apparatus can be of a size for a baby, a child, an adult, or anywhere in between. For example, the longitudinal alignment apparatus,, when configured for an adult, is approximately ten (10") inches in the longest direction.

H9:5| Various views of two sides of the guide apparatus 220 with one supporting member 224 are shown in FIGS. 33-38. The guide apparatus 220 can include two separate, matching halves (e.g., 220' and 220") that are configured to be placed above the inner portions 206 of the longitudinal alignment apparatus 200. The guide apparatus 220, for example, can include cap-like structures 222 that are configured to overlay the respective inner portions 206. Indeed, the guide apparatus 220 can have a different number of caps, as long as the number of caps is not less than the number of inner portions. Each cap-like structure 222 aligns with each inner portion 206 to facilitate the realignment of the sternal sections SI' and S2', FIGS. 39-44 illustrate various views of an alternate embodiment of the guide apparatus 310 with three supporting members 312, 314, 316 and a different number of caps surrounding the supporting members.

[0Θ96] In either embodiment, the supporting members 220, 310 can have a guiding portion that can accept a slider apparatus therewithin. As illustrated, the supporting members (e.g., 204. 312, 314, 316) can have a female connector that can mate with a male connector of a slider apparatus and secure the slider apparatus in position. Various views of example of the slider apparatus 230 are shown in FIGS. 45-50. The slider apparatus 230 can include a drill guide 232 and one or more male connectors 234. The male connectors 234 can mate wish the female connectors of the supporting members (e.g., 204, 312, 314, 316) to hold the drill guide 232 of the slider apparatus 230 in place. The drill guide 232 facilitates drilling holes in i e sternum at substantially the same location on either side. The drill guide 232 facilitates drilling holes in the sternum at substantially the same location on either side. The drill guide 232 is of a shape that can hold a drill bit to ensure that the drill bit does not slip while drilling the holes in the sternum. The holes can be used to facilitate substantially perfect realignment and reconneetios of the sterna! bone after the sternal surgery. Accordingly, the sternal realignment system and associated methods can be used to achieve a substantially perfect realignment and ^connection of fee sternal bone, believed to increase healing, and further believed to reduce the risk of infection and wound dehiscence. Additionally, the sternal realignment system and methods can reduce or eliminate the amount of wiring with screws or fasteners required during conventional sternotomy.

[ΌΘ97] In the foregoing specification, specific embodiments have been described. However, one of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the disclosure as set forth in the claims below. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present teachings.

Θβ98] The benefits, advantages, solutions to problems, and any elements) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements of any or all the claims. The disclosure is defined solely by the appended claims including any amendments made during the pendency of this application and all equivalents of those claims as issued.

| 99J Moreover in this document, relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terns "comprises," "comprising," "has", "having," "includes", "including," "contains'', "containing" or any other variation thereof, are intended to cover a non-exclusive inclusion, such thai a process, method, article, or apparatus that comprises, has, includes, contains a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises ...a", "has ...a", "includes ...a", "contains ...a'" does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises, has, includes, contains the element. The terras "a" and "an" are defined as one or more unless explicitly stated otherwise herein. The terms "substantially'⁵, "essentially", "approximately", "about" or any other version thereof, are defined as being close to as understood by one of ordinary skill in the art. Tn one non-limiting embodiment the terms are defined to be within for example 10%, in another possible embodiment within 5%, in another possible embodiment within 1%, and in another possible embodiment within 0.5%, The term "coupled" as used herein is defined as connected or in contact either temporarily or permanently, although not necessarily directly and not necessarily mechanically. A device or structure that is "configured" in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

[001001 To the extent that the materials for any of the foregoing embodiments or components thereof are not specified, it is to be appreciated that suitable materials would be known by one of ordinary skill in the art for the intended purposes.

[001011 The Abstract of the Disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, In the foregoing Detailed Description, it can be seen that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter iies in less than all features of a single disclosed embodiment. Thus the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.

Claims

What is claimed is:

1 , An apparatus for aligning sections of a sterna! bone comprising:

a frame supported by a plurality of generally longitudinal and lateral rails;

a damping fixture secured to at least a portion of one of said longitudinal rails or said lateral rails, the clamping fixture for securing said apparatus a section to the sterna! bone during use; and

a selectively moveable guide block that is raovabiy supported by said lateral rails, the guide block comprising a plurality of drill openings substantially parallel to said lateral rails for creating sagittal openings in sections of a sternal bone during rise,

2, The apparatus for aligning sections of the sterna! bone of claim ! wherein said moveable guide block further comprises drill block alignment lines on the surface of the guide block that are aligned to corresponding pin lines marked on the sternal bone sections during use.

3, A method for aligning sections of a sternal bone, the method comprising the steps of:

inserting an alignment apparatus having a frame supported by a plurality of generally longitudinal and lateral rails;

securing at least one clamping fixture that is fixedly attached to at least a portion of one of said longitudinal rails or said lateral rails to the sternal bone with a fastener that is adjustably attached to the clamping fixture;

moving a guide block that is movably supported by said lateral rails, the guide block comprising a plurality of drill openings substantially parallel to said lateral rails; and drilling a plurality of sagittal openings through said drill openings in sections of a sternal bone.

4. The method for aligning sections of the sternal bone of claim 3 further comprising the step of aligning at least one block line located on a surface of said guide block with a corresponding pin line located on a section of a sternal bone.

5, The method for aligning sections of the sternal bone of claim 4 further comprising the step marking a sternal bone with said pin line for alignment with said block line located on said surface of said guide block.

6, A system for aligning sections of a sternal bone comprising:

a longitudinal alignment apparatus comprising a frame having first and second sides, said first and second s des supporting a plurality of rings;

said rings having a respective inner portion anchored by a fastener during use to the sternal bone;

a guide arrangement for positioning onto the plurality of irmer portions of said rings once anchored by fasteners to the sternal bone, the guide arrangement having a supporting member; and

a slider apparatus for insertion into said supporting member of said guide

arrangement, wherein said slider apparatus comprises an aperture for receiving a drilling device,

7. The system for aligning sections of the sternal bone of claim 6, wherein said inner portions of said rings are selectively removable from said rings.

8. The system for aligning sections of the sternal bone of claim 6, wherein said inner portions operate as a position guide for the guide arrangement,

9. The system for aligning sections of the sternal bone of claim 6, wherein the guide arrangement is arranged onto the plurality of inner portions on each side of the patient's sternum after the sternum has heen surgically opened,

10. The system for aligning sections of die sternal bone of claim 6 further comprises a respective fastener for each inner portion of said ring, said fasteners securing said inner portions to said sternal bones during use, and allowing the separation of said rings from said inner portions once the Inner portions are anchored to the sterna! bone, said inner portions further comprising a recess for seating said fasteners such that the fasteners are flush with an outer-most extremity of said inner portion and allowing a respective cap on said guide arrangement to nest without interference onto a respective inner portion.

! 1. A method for substantially symmetrically aligning sections of a sternal bone, the method comprising the steps of:

placing a longitudinal alignment apparatus on a patient's sternal bone, the longitudinal alignment apparatus comprising first and second sides;

securing a plurality of alignment inner portions that are removably attached to the longitudinal alignment apparatus into the patient's sternal bone;

removing at least a portion of the longitudinal alignment apparatus from the patient's sternal bone, while leaving the alignment inner portions secured to the sternal bone;

placing a guide arrangement onto the plurality of alignment inner portions on sectioned sides of the patient's sternal bone;

inserting a slider apparatus into each side of the guide arrangement, wherein said slider apparatus comprises an opening for receiving a drilling device; and drilling a plurality of openings hi sections of a sternal bone through the openings,

12, The method for substantially symmetrically aligning sections of the sternal bone of claim 1 1, wherei the steps of placing the longitudinal alignment apparatus on the patient's sternal bone, securing the plurality of alignment inner portions the patient's sternal bone; and removing at least the portion of the longitudinal alignment apparatus from the patient's sternal bone occur before the sternum is surgically opened.

13. The method for substantially symmetrically aligning sections of the sternal bone of claim 11_» wherein the steps of placing the guide arrangement onto the plurality of alignment inner portions on sectioned sides of the patient's sternal bone; inserting the slider apparatus into each side of the guide arrangement; and drilling a plurality of openings in sections of a sternal bone through the openings occur after the sternum is surgically opened.

14. The method for substantially symmetrically aligning sections of the sternal bone of claim 11, wherein the longitudinal alignment apparatus further comprises a frame apparatus with a. plurality of longitudinally symmetric rings and respective alignment inner portions inside the plurality of longitudinally symmetric rings.

15. The method for substantially symmetrically aligning sections of the sternal bone of claim 14, wherein the plurality of alignment inner portions are secured by a plurality of screws threaded into Hie respective alignment inner portions.

16. The method for substantially symmetrically aligning sections of the sternal bone of claim 15, wherein an outer portion of the alignment apparatus is removed, while the alignment inner portions remain secured by the plurality of screws,

17. The method for substantially symmetrically aligning sections of the sternal bone of claim I I. wherein at least a portion of the slider apparatus extends in a direction perpendicular to the guide arrangement

18, The method for substantially symmetrically aligning sections of the sternal bone of claim 11, wherein the step of drilling the plurality of openings further comprises positioning -a drill bit in the same horizontal location on both sides the sternum based on the slider apparatus.

19, The method for substantially symmetrically aligning sections of the sternal bone of claim 1 1, further comprising inserting a dowel through the drilled openings to facilitate aligning the sections of the sternal bone,

20. The method for substantially symmetrically aligning sections of the stema! bone of claim 11, further comprising removing the guide arrangement after the step of drilling the plurality of openings.