EP1887949A1 - Systeme de correction de la colonne vertebrale - Google Patents

Systeme de correction de la colonne vertebrale

Info

Publication number
EP1887949A1
EP1887949A1 EP06770186A EP06770186A EP1887949A1 EP 1887949 A1 EP1887949 A1 EP 1887949A1 EP 06770186 A EP06770186 A EP 06770186A EP 06770186 A EP06770186 A EP 06770186A EP 1887949 A1 EP1887949 A1 EP 1887949A1
Authority
EP
European Patent Office
Prior art keywords
leg
vertebra
bridge member
width
left leg
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.)
Withdrawn
Application number
EP06770186A
Other languages
German (de)
English (en)
Other versions
EP1887949A4 (fr
Inventor
Eric J. Wall
Donita I. Bylski-Austrow
Joseph E. Reynolds
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.)
Cincinnati Childrens Hospital Medical Center
Spineform LLC
Original Assignee
Cincinnati Childrens Hospital Medical Center
Spineform LLC
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
Priority claimed from US11/126,782 external-priority patent/US8021403B2/en
Application filed by Cincinnati Childrens Hospital Medical Center, Spineform LLC filed Critical Cincinnati Childrens Hospital Medical Center
Publication of EP1887949A1 publication Critical patent/EP1887949A1/fr
Publication of EP1887949A4 publication Critical patent/EP1887949A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7059—Cortical plates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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
    • A61B17/809—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with bone-penetrating elements, e.g. blades or prongs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/92—Impactors or extractors, e.g. for removing intramedullary devices
    • A61B2017/922—Devices for impaction, impact element

Definitions

  • This invention relates to devices for use in the correction, arresting or slowing of abnormal curvature of the spine, including scoliosis, hyperlordosis and hypokyphosis.
  • Juvenile and adolescent scoliosis is a disorder of the growing spine in which a predominantly lateral curvature develops. Curves over 40° can require surgical correction due to the high risk of future progression during adulthood.
  • One typical procedure, often called "posterior approach scoliosis surgery,” is one of the most invasive human surgeries in orthopedics. During a typical three to eight hour procedure, a surgeon strips the strong posterior muscles off of the spine for bone exposure, then attaches two metal rods to the spine with hooks, wires, or screws.
  • scoliosis approach is through the anterior chest via thoracotomy or thoracoscopy. After multi-level discectomy and fusion, large screws are placed across the vertebral bodies, and then the screws and vertebrae are compressed together by means of a vertical rod.
  • Staples are often used in orthopaedics to fix two bones or pieces of bone together, such as would be required for osteotomy (bone cutting), or fracture stabilization. Staples typically used for these purposes are disclosed in U.S. Patents 4,434,796 by Karapetian; 3,862,621 to Austin; 4,841,960 to Garner; 4,848,328 to laboureau et al.; 5,449,359 to Groiso; 5,053,038 to Sheehan; and 4,913,144 to Del Medico.
  • Orthopaedic staples are also used in the fixation of soft tissue to bone, such as tendon or shoulder tissue. Staples typically used for these purposes are described in U.S. Patents 5,352,229 to Goble et al.; 4,462,395 to Johnson; 4,570,623 to Ellison et al.; 4,454,875 to Pratt et al.; D320,081 to Johnson; and D340,284 to Johnson.
  • the inventors have developed a novel procedure and spinal correction system for correcting scoliosis in children that takes advantage of future spine growth to correct the scoliosis. This procedure relies upon slowing spine epiphyseal growth on the convex side of the scoliosis curve with a novel hemiepiphyseal spinal correction system.
  • novel procedure using the novel spinal correction system requires only about one-fourth of the time necessary for conventional implantation techniques and may be performed using minimally invasive endoscopic procedures.
  • novel spinal correction system has an extremely low profile which reduces the risk of neurological complications.
  • This new procedure illustratively uses a novel system of staples and screws to provide anterior non-fusion (no bone graft) correction of scoliosis in children with significant growth remaining.
  • the procedure can be performed entirely endoscopically in as little as one hour of surgical time.
  • This procedure using the novel spinal staple avoids the complex rod-screw linkage of current anterior scoliosis corrective systems. It also holds the potential for making correction an outpatient procedure and minimizes blood loss during surgery.
  • a spinal staple meant to stabilize the screw-bone interface of a screw and rod system.
  • U.S. Patent 4,047,523 to Hall discloses a surgical sacral anchor implant that is half of a staple blade affixed to a cable for the fixation of the lower end of the spine.
  • U.S. Patent 5,395,372 to Holt et al. is a spinal staple that holds a strut bone graft in place and is designed for use after vertebrectomy.
  • Bone plowing can reduce the force magnitudes applied to the bone's growth plates and may also be associated with device deformation or dislodgment. As a staple plows through bone it may partially dislodge such that the staple crown moves away from the bone.
  • a spinal correction system includes a spinal staple having a bridge member with a length sufficient to span the vertebral endplate growth centers on either side of a vertebral disk.
  • a pair of spaced apart wedged-shaped legs extend downwardly from the end of the bridge member and are of such a length as to penetrate no more than about half way into the depth of a vertebra.
  • Fastener retaining portions extend horizontally outward from the opposite ends of the bridge member and define passageways therethrough adapted to receive fasteners such as screws and the like. The fastener retaining portions are proportioned so that when two or more of the spinal staples of the invention are arranged in end-to-end adjoining relationship, the fastener retaining portions extending from the abutting ends lie side by side.
  • the legs of the staple are equipped with barbs to resist backing out or loosening of the staple after it has been affixed to a vertebra.
  • the fastener retaining portions have barbs or projections extending from a lower surface thereof to promote fixation of the staple in a vertebra.
  • the staple may be provided with a threaded cannulated post extending upward from the upper surface of the bridge member to allow attachment of a threaded removable, cannulated impaction device.
  • additional surgical hardware may be conveniently affixed to the staple by means of the threaded post.
  • the staple may also include anti-rotation members extending outwardly from the legs and configured to assist in the prevention of rotational deformity.
  • the legs of the staple have a transverse cross-sectional area (defined by width and length of the legs) configured to ensure adequate contact surface against the vertebra to compress sufficient endplate growth areas, to provide an appropriate pattern of compression distribution, to prevent plowing, and to reduce joint motion.
  • the transverse cross-sectional area of the legs is at least 10 percent of the cross-sectional area of the respective vertebra, and the length of the legs is up to 40 percent of the transverse width of the respective vertebra.
  • the ratio of the leg width to its length is illustratively greater than about one-half to accommodate variations in patient mass and size, and the cross-sectional area of the vertebrae as a function of age and vertebral level.
  • Fig. 1 is a perspective view of a spinal staple in accordance with the invention
  • Fig. 2 is a front elevation view of the spinal staple of Fig. 1;
  • Fig. 3 is a perspective view of the spinal staple showing the underside of the staple
  • Fig. 4 is a top plan view of the spinal staple
  • Fig. 5 is an end elevation view of the spinal staple
  • Fig. 6 is a perspective view of two of the spinal staples in accordance with the invention aligned in end-to-end adjoining relationship;
  • Fig. 7 is a top plan view of three of the spinal staples of the invention installed in a spine in end-to-end relationship;
  • Fig. 8 is an elevation view in partial section of a spinal correction system in accordance with the invention affixed to two vertebrae so as to span two endplate growth centers and an intervening disk;
  • Fig. 9 is a top plan view of an alternative embodiment of the spinal staple in accordance with the invention.
  • Fig. 10 is a perspective view of two of the alternative embodiment spinal staples aligned in end-to-end adjoining relationship;
  • Fig. 11 is a top perspective view of a further illustrative embodiment spinal staple
  • Fig. 12 is a bottom perspective view of the spinal staple of Fig. 11;
  • Fig. 13 is a side elevation view of the spinal staple of Fig. 11;
  • Fig. 14 is a transverse cross-sectional view taken along line 14-14 of Fig. 13;
  • Fig. 15 is a transverse cross-sectional view showing the spinal staple of Fig. 11 installed in a vertebra;
  • Fig. 16 is a perspective view of a further illustrative embodiment spinal staple;
  • Fig. 17 is a side elevation view of the spinal staple of Fig. 16.
  • Fig. 18 is an end view of the spinal staple of Fig. 16.
  • the staple 10 includes a bridge member 12, a pair of spaced apart legs 14, a left fastener retaining portion 16, a right fastener retaining portion 18, and an attachment member, illustratively a threaded post 20.
  • the bridge member 12 includes an upper surface or crown 22, an opposed lower surface 24, a front side 26, an opposed back side 28, a left end 30 and an opposed right end 32.
  • the upper surface 22 is substantially planar in a direction extending from the left end 30 to the right end 32, and is convex in a direction from the front side 26 to the back side 28, as may best be seen in Fig. 5 when the staple 10 is viewed from one of the ends.
  • the lower surface 24 is concave in a direction from the left end 30 to the right end 32 and from the front side 26 to the back side 28, as may best be seen in Figs. 2 and 3.
  • the bridge member 12 thus defines a pair of cooperating arches, a first arch extending between the left and right ends 30 and 32 and a second arch extending between the front and back sides 26 and 28.
  • Left and right legs 14a and 14b extend downwardly from the lower surface 24 at the left and right ends 30 and 32, and are substantially wedge-shaped.
  • Each leg 14 has an outer surface 34, an opposed inner surface 36 such that the inner surfaces 36 are facing each other, a front surface 38, and an opposed back surface 40.
  • Each of the legs 14 has a width as measured from the front surface 38 to the back surface 40, which is substantially equal to the width of the bridge member 12 as measured from the front side 26 to the back side 28. As shown in Figs. 1-3, the width of each leg 14 is several times greater than the thickness of the respective leg 14, as measured from the outer surface 34 to the inner surface 36.
  • the legs 14 narrow slightly from the front surface 38 to the back surface 40 toward their respective tips 42 which are sharply tapered to define a blade edge 43.
  • Barbs 44 illustratively project outwardly from each of the outer, inner, front, and back surfaces 34, 36, 38 and 40, respectively.
  • Each barb 44 includes a retaining surface 45 facing generally away from the respective tip 42 and facing generally toward the bridge member 12. As such, the barbs 44 are adapted to inhibit withdrawal movement of the staple 10 once the staple 10 has been positioned in its fixation environment, such as a vertebra.
  • the inner surface 36 of the legs 14 are preferably splayed, or angled, away from each other at an angle of about 10° to 20° as measured from a vertical plane 47 extending perpendicularly through the cross-section of the bridge member 12.
  • the outer surfaces 34 of the legs 14 extend downwardly substantially perpendicular to the bridge member 12 and substantially parallel to the vertical plane 47.
  • the left fastener retaining portion 16 extends outwardly from the bridge member left end 30.
  • the right fastener retaining portion 18 extends outwardly from the bridge member right end 32.
  • Each of the fastener retaining portions 16, 18 define a passageway 46 therethrough adapted to receive therein a fastener 68, such as a screw (Fig. 8).
  • the fastener retaining portions 16, 18 and the passageways 46 are adapted to guide a fastener 68 in a direction substantially parallel to the legs 14.
  • the fastener retaining portions 16, 18 each include front and back sides 49 and 51 and are proportioned so that when two of the staples 10 are in end-to-end abutting relation, as shown in Fig.
  • the fastener retaining portions 16, 18 extending from abutting ends are in side to-side adjoining relation to each other.
  • the left fastener retaining portion 16 on one staple 10 lies alongside the right fastener retaining portion 18 of the other staple 10.
  • the back side 51 of the left fastener retaining portion 16 of a first staple 10 is positioned in proximity to and facing the front side 49 of the right fastener retaining portion 18 of an adjacent second staple 10.
  • a longitudinal axis 48 extends through the center of the staple 10 from the left end 30 to the right end 32.
  • the left and right fastener retaining portions 16, 18 lie on opposite sides of the longitudinal axis 48.
  • the fastener retaining portions 16 and 18 may extend from opposite ends of the bridge member 12 such that both portions 16 and 18 lie to the same side of the longitudinal axis 48.
  • the staples 10 may be arranged in end-to-end abutting relation by rotating adjoining staples end-for-end 180°. Then, the left (right) fastener retaining portion 16 (18) of one staple 10 will lie alongside the left (right) fastener retaining portion 16 (18) of the adjoining staple 10. Moreover, the back side 51 of one fastener retaining portion 16, 18 will be in proximity to and facing the back side 51 of a second fastener retaining portion 16, 18.
  • Each of the fastener retaining portions 16 and 18 includes a recess, illustratively a counter sunk portion 50, adapted to receive the head of a fastener 68 therein.
  • each fastener retaining portion 16, 18 also includes a lower surface 52 having a plurality of first pointed projections 54 extending downwardly therefrom for engaging underlying bone.
  • Second pointed projections, or barbs 56 also extend downwardly from the fastener retaining portions 16, 18. As shown in Fig. 2, the pointed barbs 56 have a length greater than the pointed projections 54 and are positioned at outer extremities of the retaining portions 16 and 18 to resist rotational movement of the staple 10 about its center axis.
  • the threaded post 20 extends upwardly from the upper surface 22 of the bridge member 12.
  • the threaded post 20 cooperates with the bridge member 12 to define a passageway 58 coaxial with the post 20 and extending through the post 20 to the lower surface 24 of the bridge member 12.
  • the threaded post 20 permits the attachment of additional hardware or instruments to the staple 10, while the passageway 58 allows for the passage of a guide wire for movement therealong, if desired.
  • the cannulated threaded post 20 facilitates attachment of a threaded removable, cannulated impaction device.
  • the staple 10 may be made of titanium, surgical stainless steel, or any other material which is sufficiently strong to resist the growth of a spinal column, maintains sufficient mechanical fatigue properties, and is sufficiently non-reactive in the environment of a living animal.
  • the staples 10 are inserted into the vertebrae 60 of an animal having an immature or growing spine exhibiting scoliosis or other spinal deformity.
  • the staples 10 are of a size such that the legs 14 are spaced far enough apart that the staples 10 will bridge longitudinally or lengthwise aligned, adjoining vertebrae 60 having confronting endplate growth centers 62 with predetermined thicknesses, and an intervening disk 64 therebetween.
  • the staples 10 are driven into an intermediate portion 66, between endplate growth centers 62, of adjoining vertebrae 60 on the convex side of the curved spine.
  • the legs 14 are of such a length that they extend into the vertebrae 60 no more than one-half the transverse diameter of each vertebra 60 to ensure that pressure is applied to only one side of the vertebrae 60.
  • the legs 14 When positioned properly, the legs 14 are fully embedded in the vertebrae 60, and the projections 54 and barbs 56 of the fastener retaining portions 16, 18 engage the vertebral surfaces.
  • fasteners 68 such as screws including threaded portions, barbed stakes, or the like are inserted through the passageways 46 in the fastener retaining portions 16, 18 and into the vertebrae 60.
  • the spinal correction system when installed on a growing spine having abnormal curvature defining a convex side and an opposed concave side, with the spine including a plurality of lengthwise adjoining vertebrae 60 each having a pair of endplate growth centers 62, or longitudinal growth plates, with an intermediate portion 66 in between, the vertebrae 60 also having a particular transverse diameter, width, or thickness in a direction measured from the convex side to the concave side, is broadly seen to include a first bone engaging means or leg 14 that penetrates the convex side of an intermediate portion 66 of a first vertebra 60a to a depth of less than one-half the diameter of the first vertebra 60a, a second bone engaging means or leg 14 penetrating the convex side of an intermediate portion 66 of a second vertebra 60b to a depth of less than one-half the diameter of the second vertebra 60b, and a bridge member 12 connecting, illustratively rigidly, the first and second bone engaging means 14 (Fig. 8).
  • the spinal correction system 10 thus corrects the abnormal curvature of the growing spine by inhibiting or retarding the growth of the endplate growth centers 62 captured between the first and second bone engaging means 14 on the convex side of the spine, while permitting the unrestrained growth of the endplate growth centers 62 on the concave side of the spine.
  • the concave side of the spine will grow faster relative to the convex side, thereby resulting in slowing curve progression, and possibly in flattening of the curvature and straightening of the spine.
  • the legs 14 are primarily responsible for restraining the growth of the endplate growth centers 62 captured therebetween, it will be seen that the fastener retaining portions 16, 18 and fasteners 68 also contribute to restraining the growth of the endplate growth centers 62 captured therebetween.
  • the legs 14 may even be omitted provided that the fastener retaining portions 16, 18 and cooperating fasteners 68 are adapted to sufficiently resist the spreading forces due to lengthwise growth of the endplate growth centers 62.
  • FIG. 11-14 A further illustrative embodiment spinal staple 10' is shown in Figs. 11-14.
  • the spinal staple 10' includes many of the same features of the earlier described spinal staple 10. As such, in the following description, like reference numbers identify like components as detailed with respect to the embodiment of Figs. 1-10.
  • the inner surfaces 36 of the left and right legs 14a' and 14b' are configured to distribute compression pressure on the endplate growth centers 62 of vertebrae 60 in a manner slowing growth unilaterally and avoiding bone plowing.
  • the spinal staple 10' is configured to induce a particular pattern of compression distribution. Factors that affect the distribution pattern of the compression within the endplate growth centers 62 include the length and width of the legs 14', which together define the transverse cross-sectional area of the legs 14', along with other structural features of the staple 10 and the placement of the legs 14' within the vertebrae 60. Bone plowing tends to relieve the therapeutic pressure place on the endplate grow centers 62 of the vertebrae 60, thereby allowing the disease to progress.
  • the transverse cross-sectional area (LA) of the legs 14a' and 14b' is at least 10 percent of the cross-sectional area (VA) of the first vertebra 60a and the second vertebra 60b, respectively.
  • the cross-sectional area (LA) of the legs 14a' and 14b' is between 10 percent and 25 percent of the vertebral cross-sectional area (VA).
  • the width (LW) of each leg 14' is greater than about 6 millimeters (0.236 inches), hi one illustrative embodiment, the width (LW) is between 7 millimeters (0.276 inches) and 14 millimeters (0.552 inches).
  • the length (LL) of each leg 14' illustratively does not extend over one-half of the vertebral diameter or transverse width (VW) (Fig. 15).
  • the length (LL) of each leg 14a' and 14b' is between 10 percent and 40 percent of the transverse width (VW) of the first vertebra 60a and the second vertebra 60b, respectively.
  • the length (LL) of each leg 14a' and 14b' is less than 24 millimeters (.945 inches).
  • the length (LL) is between 3 millimeters (0.118 inches) and 15 millimeters (0.59 inches).
  • leg width (LW) to length (LL) may be adjusted to take into account the patient's size requirement or scale, hi other words, in larger people a longer leg length (LL) may be justified.
  • the width (LW) should be wider to support a greater load related to the patient's greater dynamic loads, muscle forces, forces of motion, and vertebral/physeal cross-sectional area.
  • the upper thoracic spine is much smaller than that of the lower thoracic or lumbar spine, and the vertebral bodies of a young child are generally smaller than those of an adolescent.
  • the ratio of staple leg length (LL) to the staple leg width (LW) is also important to generate the proper pattern of compressive stress gradient across the coronal plane of the vertebral endplate growth center 62, slowing or stopping growth on the stapled side of the vertebrae 60 and allowing unrestrained growth on the unstapled side of the vertebrae 60.
  • the ratio of leg width (LW) to length (LL) is greater than about one-half. In other words, the width (LW) of the staple leg 14' is at least about 50 percent of its length (LL).
  • an anti-rotation member 80 is located outboard of each staple leg 14' and abuts an adjacent fastener retaining portion 16, 18. More particularly, a left anti-rotation member 80a extends between the left fastener retaining portion 16 and the left leg 14a, and a right anti-rotation member 80b extends between the right fastener retaining portion 18 and the right leg 14b.
  • the anti-rotation members 80 are positioned outboard to the staple legs 14 to bite into the bone of vertebrae 60 without cutting into the endplate growth centers 62.
  • the left and right anti-rotation members 80a and 80b are configured to reduce relative rotation of the left and right fastener retaining portions 16 and 18 about the longitudinal axis 48 relative to the first and second vertebrae 60a and 60b, respectively.
  • Each anti-rotation member 80 includes a lower edge 82 configured to engage the bone of the vertebra 60 such that it is anchored. More particularly, the lower edge 82 of the left anti-rotation member 80a is configured to engage the first vertebra 60a, and the lower edge 82 of the right anti-rotation member 80b is configured to engage the second vertebra 60b. As such, the lower edge 82 may be sharpened such that it cuts into the vertebral bone.
  • the lower edge 82 illustratively extends parallel to the longitudinal axis 48 and upwardly from the leg 14' to the respective fastener retaining portion 16, 18. More particularly, each anti-rotation member 80 extends from proximate the center of the outer surface 34 of leg 14' to the fastener retaining portion 16, 18.
  • the anti-rotation members 80 comprise triangular shaped plates that appear as gussets.
  • the anti-rotation members 80 could be formed of plates defining other shapes, such as rectangles or semi-circles.
  • the anchoring of the anti-rotation members 80 within the bone increases the load required to dislodge the staple 10' from relative rotation of the first and second vertebrae 60a and 60b bridged by the staple 10'.
  • the anti-rotation members 80 may assist in preventing the bending of the legs 14' relative to the bridge member 12, and the formation of rotational deformity.
  • the anti-rotation members 80 may also help prevent relative rotation between the first and second vertebrae 60a and 60b about the longitudinal axis of the spine and the flexion-extension axis.
  • the anti- rotation members 80 also may reduce the likelihood of relative movement of the staple 10' to the vertebrae 60 to improve stability.
  • the anti-rotation members 80 may help prevent rotation of the staple 10' relative to the first and second vertebrae 60a and 60b about the longitudinal axis of the spine and the axis 74 extending through the opening 58 of the staple 10'.
  • spinal staple 100 is shown in Figs. 16-18.
  • the spinal staple 100 include many of the same features of the earlier described spinal staples 10, 10'. As such, in the following description, like reference numbers identify like components as detailed with respect to the embodiments of Figs. 1-15.
  • the spinal staple 10' of Figs. 11-15 and the spinal staple 100 of Figs. 16-18 are first and second portions 116 and 118 separated by a void or space 120.
  • the reduced area of tip edges 122 of the portions 116 and 118 may result in easier insertion of the legs 114 into the bone of the vertebrae 60.
  • the collective dimensions thereof should illustratively satisfy the criteria detailed above with respect to the legs 14' of staple 10'. More particularly, in order to ensure adequate contact surface against the vertebrae 60, the collective transverse cross- sectional area (LA) of the portions 116 and 118 of each leg 114 is illustratively at least 10 percent, and in one illustrative embodiment not more than 25 percent, of the vertebral cross sectional area (VA) of the first vertebra 60a and the second vertebra 60b, respectively.
  • each leg 114 is greater than about 6 millimeters (0.236 inches), and illustratively between 7 millimeters (0.276 inches) and 14 millimeters (0.552 inches). Also, the length (LL) of each portion 116 and 118 of legs 114 does not extend over one-half of the vertebral transverse width (VW), and is illustratively less than 24 millimeters (.945 inches). Finally, the collective leg width (LW) of each leg 114 is illustratively at least about 50 percent of the average length (LL) of the portions 116 and 118.
  • spinal correction system is intended primarily for correcting abnormal lateral curvature of an immature or growing spine, it may also be used for spinal correction in humans having mature or non-growing spines.

Abstract

L’invention concerne un système de correction de la colonne vertébrale (10) permettant de corriger ou d’enrayer la scoliose ou les déformations des colonnes vertébrales immatures. Le système comporte un élément de raccord (12), une paire de pieds espacés (14) se prolongeant sensiblement perpendiculairement à celui-ci, et une partie de maintien de fixation (16, 18) se prolongeant sensiblement longitudinalement de chaque extrémité de l’élément de raccord (12).
EP06770186A 2005-05-11 2006-05-11 Systeme de correction de la colonne vertebrale Withdrawn EP1887949A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US67988605P 2005-05-11 2005-05-11
US11/126,782 US8021403B2 (en) 1999-07-07 2005-05-11 Spinal staple system
PCT/US2006/018110 WO2006122194A1 (fr) 2005-05-11 2006-05-11 Systeme de correction de la colonne vertebrale

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AU2006244021A1 (en) 2006-11-16
CA2607921C (fr) 2013-07-16
WO2006122194A1 (fr) 2006-11-16
CA2607921A1 (fr) 2006-11-16
KR101272242B1 (ko) 2013-06-11
EP1887949A4 (fr) 2011-08-24

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