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WO2016036800A1 - Système et méthode de réalignement sternal - Google Patents

Système et méthode de réalignement sternal Download PDF

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Publication number
WO2016036800A1
WO2016036800A1 PCT/US2015/048057 US2015048057W WO2016036800A1 WO 2016036800 A1 WO2016036800 A1 WO 2016036800A1 US 2015048057 W US2015048057 W US 2015048057W WO 2016036800 A1 WO2016036800 A1 WO 2016036800A1
Authority
WO
WIPO (PCT)
Prior art keywords
sternal
bone
sternal bone
sections
inner portions
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2015/048057
Other languages
English (en)
Inventor
Peter D. Winch
William Ray
Jeremy Patterson
Robert Strouse
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nationwide Childrens Hospital Inc
Original Assignee
Nationwide Childrens Hospital Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nationwide Childrens Hospital Inc filed Critical Nationwide Childrens Hospital Inc
Publication of WO2016036800A1 publication Critical patent/WO2016036800A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8866—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices for gripping or pushing bones, e.g. approximators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8076—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the ribs or the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1789—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the sternum

Definitions

  • 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.
  • 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 ⁇ 3 ⁇ 4 sternal bone during use.
  • 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.
  • 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.
  • 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
  • FIG, 3 is a perspective view of FIG. 2;
  • 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
  • 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
  • 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
  • FIG. 7 is a front elevation view of FIG. 5;
  • FIG. 8 is an end view of the sternal realignment apparatus constructed i accordance with one example embodiment of the present disclosure.
  • FIG. 9 is a side view of the sternal realignment apparatus constructed in accordance with one example embodiment of the present disclosure.
  • 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.
  • 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,
  • 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.
  • 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.
  • 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,
  • 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.
  • 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.
  • 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,
  • 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.
  • 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.
  • 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.
  • FIG. 21 is a perspective view of the longitudinal alignment apparatus of fee sternal alignment system shown in FIG. 10.
  • FIG, 22 is a side elevated view of the longitudinal alignment apparatus of FIG, 21.
  • FIG, 23 is a top view of the longitudinal alignment apparatus of FIG, 2L
  • FIG, 24 is a bottom view of the longitudinal alignment apparatus of FIG. 21 .
  • 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.
  • FIG. 27 is a perspective view of the longitudinal alignment apparatus of the sterna! alignment system shown in FIG, 19.
  • FIG. 28 is a side elevated view of the longitudinal allotment apparatus of FIG. 27.
  • FIG. 29 is a top view of the longitudinal alignment apparatus of FIG. 27.
  • FIG. 30 is a bottom view of the longitudinal alignment apparatus of FIG. 27,
  • FIG. 31 is a left view of the longitudinal alignment apparatus of FIG. 27,
  • FIG, 32 is a right view of the longitudinal alignment apparatus of FIG. 27.
  • FIG. 33 is a perspective view of the guide arrangement of the sternal alignment system having one supporting member shown in FIG. 14.
  • FIG. 34 is a side elevated view of the guide arrangement of FIG. 33.
  • FIG, 35 is a top view of the guide arrangement of FIG. 33.
  • FIG. 36 is a bottom view of the guide arrangement of HO. 33 .
  • FIG. 37 is a left view of trie guide arrangement of FIG. 33.
  • FIG, 38 is a right view ofl e guide arrangement of FIG. 33.
  • FIG. 39 is a perspective view of the guide arrangement of the sternal alignment system having three supporting members as shown in FIG. 19.
  • FIG, 40 is a side elevated view of the guide arrangement of FIG. 39.
  • FIG. 41 Is a top view of the guide arrangement of FIG. 39.
  • FIG, 42 s a bottom v ew of the guide arrangement of FIG. 39.
  • FIG. 43 is a left view of the guide arrangement of FIG. 39.
  • FIG. 44 is a right view of the guide arrangement of FIG, 39,
  • 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,
  • FIG . 46 is a side elevated view of the slider apparatus shown in FIG, 45,
  • FIG. 47 is a top view of the slider apparatus shown in FIG. 45.
  • FIG, 48 is a bottom view of the slider apparatus shown in FIG. 45.
  • FIG. 49 s a left view of the slider apparatus shown in FIG. 45.
  • FIG. 50 is a right view of the slider apparatus shown Irs FIG. 45,
  • 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.
  • FIG. 1 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.
  • 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 D 5 .
  • 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,
  • 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.
  • 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.
  • 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.
  • 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.
  • the sternal realignment apparatus 10 in the illustrated example embodiment is constructed from metal, for example, stainless steel
  • 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.
  • 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.
  • the substantially rectangular guide drill block 26 is substantially nine (9") inches in length along the top 40, one ( ⁇ ) 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.
  • 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.
  • 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
  • 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.
  • each of the clamping fixtures comprise a c-shaped opening 52 for receiving the sternal section SI or S3 ⁇ 4 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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,
  • 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.
  • the pins 82, 84, and 86 are formed from a bone graph or a composite material compatible with bone tissue.
  • 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,
  • 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.
  • the amount of wiring with screws or fasteners required for additional securing used in conventional sternotomy is reduced or possibly eliminated.
  • FIGS. 10-50 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.
  • the sternal realignment system -and methods can reduce or eliminate die amount of wiring with screws or fasteners required during conventional sternotomy.
  • FIG, 10 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'.
  • the longitudinal alignment apparatus 200 can be applied to a patient's sternal bone.
  • the longitudinal alignment apparatus 200 is substantially symmetrically positioned about section line D ⁇ [0 ⁇ 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.
  • 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.
  • 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.
  • 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,
  • 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),
  • 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'rome 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.
  • 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.
  • 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.
  • 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.
  • a guide arrangement 220 s and 220" is placed onto the inner portions 206, one per sectioned side SP, S2' of the sternum.
  • 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,
  • 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.
  • 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 ⁇
  • 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.
  • the one or more supporting members 224 include one or more portions configured to mate with a portion of the slider apparatus 230.
  • 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.
  • the slider apparatus 230 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.
  • 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.
  • the sternum S * can be closed, as shown in FIG. 18.
  • at least portion of the system is not removed until after closure of the sternum S*.
  • 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.
  • one or more closure devices 250 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.
  • 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.
  • FIGS. 1 and 20 An alternate example embodiment of the sternal realignment system is shown in FIGS. 1 and 20,
  • 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.
  • 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.
  • 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.
  • 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.
  • the longitudinal alignment apparatus can be of a size for a baby, a child, an adult, or anywhere in between.
  • the longitudinal alignment apparatus when configured for an adult, is approximately ten (10") inches in the longest direction.
  • FIGS. 33-38 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.
  • the supporting members 220, 310 can have a guiding portion that can accept a slider apparatus therewithin.
  • the supporting members e.g., 204. 312, 314, 316
  • the supporting members can have a female connector that can mate with a male connector of a slider apparatus and secure the slider apparatus in position.
  • FIGS. 45-50 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.
  • 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.
  • the sternal realignment system and methods can reduce or eliminate the amount of wiring with screws or fasteners required during conventional sternotomy.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurology (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des systèmes, des appareils et des méthodes permettant d'aligner des sections d'un os sternal. Un exemple comprend une structure supportée par une pluralité de rails généralement longitudinaux et latéraux. Un dispositif de serrage est fixé à au moins une partie de l'un des rails, et un bloc de guidage sélectivement mobile est supporté de manière mobile par les rails latéraux. Le bloc de guidage comprend une pluralité d'orifices de forage sensiblement parallèles aux rails latéraux permettant de créer des orifices sagittaux dans lesdites sections d'un os sternal au cours de l'utilisation. Un autre exemple comprend un appareil d'alignement longitudinal comprenant une structure ayant un premier et un second côté qui supportent une pluralité d'anneaux comprenant des parties internes respectives qui sont ancrées dans l'os sternal. Un système de guidage comprenant un élément de support est positionné sur la pluralité de parties internes. Un appareil à glissière, une ouverture destinée à recevoir un dispositif de forage, est inséré dans l'élément de support.
PCT/US2015/048057 2014-09-04 2015-09-02 Système et méthode de réalignement sternal Ceased WO2016036800A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462045944P 2014-09-04 2014-09-04
US62/045,944 2014-09-04

Publications (1)

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WO2016036800A1 true WO2016036800A1 (fr) 2016-03-10

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5928231A (en) * 1995-05-19 1999-07-27 Klein; Jean-Michel Implantable osteosynthesis device
US20070038218A1 (en) * 2005-08-12 2007-02-15 Mark Grevious Sternal closure device
US20090118775A1 (en) * 2007-11-01 2009-05-07 Burke Shawn M Sternal Clamp

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5928231A (en) * 1995-05-19 1999-07-27 Klein; Jean-Michel Implantable osteosynthesis device
US20070038218A1 (en) * 2005-08-12 2007-02-15 Mark Grevious Sternal closure device
US20090118775A1 (en) * 2007-11-01 2009-05-07 Burke Shawn M Sternal Clamp

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