MX2007014076A - Spinal correction system - Google Patents

Abstract

A spinal correction system (10) for the correction or arrest of scoliosis or spinal deformity in immature spines includes a bridge member (12), a pair of spaced apart legs (14) extending substantially perpendicularly therefrom, and a fastener retaining portion (16, 18) extending substantially longitudinally from each end of the bridge member (12).

Description

SYSTEM D? SPINAL CORRECTION FIELD OF THE INVENTION This invention relates to devices for use in correcting, stopping or delaying the abnormal curvature of the spine, including scoliosis, hyperlordosis and hypokyposis.

BACKGROUND OF THE INVENTION Adolescent and adolescent scoliosis is a developing spinal disorder in which a predominantly lateral curvature develops. Curves greater than 40a may require surgical correction due to the high risk of future progression during adulthood. A 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 removes the strong posterior muscles of the spine for bone exposure, then attaches two metal rods to the spine with hooks, wires or screws. An alternative scoliosis procedure is through the anterior chest via the thoracotomy or thoracoscopy. After discectomy and multi-level fusion, large screws are placed through the vertebral bodies, and SEFo §187571 then the screws and the vertebrae are compressed together by means of a vertical rod. Staples are often used in orthopedics to fix two bones or pieces of bones together, as may be required for osteotomy (bone cutting) or fracture stabilization. Staples typically used for these purposes are described in U.S. Patent Nos. 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. Orthopedic staples are also used in the fixation of soft tissue to the bone, such as tendons or shoulder tissues. Staples typically used for this purpose are described in U.S. Patent Nos. 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. In addition, several screws with a connecting plate or rod have been developed for fixing the anterior spine and are described in the Patents of the United States Nos. 5,324,290 to Zdeblick et al .; and 4,041,939 to Hall. U.S. Patents describe spine staples, e.g., U.S. Patent Nos. 4,047,523 to Hall; 4,047,524 to Hall; 5,395,372 to Holt et al .; D378,409 to Michelson; and D364,462 to Michelson. The inventors have developed a novel procedure and spinal correction system to correct scoliosis in children, which takes advantage of the future growth of the spine to correct scoliosis. This procedure relies on the growth retardation of the spinal epiphysis on the convex side of the scoliosis curve, with a new system of hepiphyseal spinal correction. The novel procedure that uses the spinal correction system requires only a quarter of the time necessary for conventional implantation techniques, and can be performed using minimally invasive endoscopic procedures. In addition, the novel spinal correction system has an extremely low profile that reduces the risk of neurological complications. This new procedure uses illustratively a new system of staples and screws to provide anterior non-fusion correction (without bone graft) of scoliosis in children with significant growth remaining. The procedure can be performed completely endoscopically in as little time as one hour of surgery. This procedure using the new spinal staple avoids the complex rod-screw connection of the current anterior scoliosis corrective systems. This contains the potential to perform correction on an external patient, minimizes blood loss during surgery. The existing spinal implants do not effectively take advantage of the principle of hemiepiphysiodesis to alter the growth of the spine and allow gradual correction through asymmetric growth. Fixing shake two bones or pieces of bones together, for example, are not designed to perform hemiepiphysiodesis, and are not designed or are able to withstand the forces of spinal movement and growth without significant extension. Orthopedic staples used to attach soft tissue to bone are not designed to span two bones or two pieces of bone. In this way, two staples are inapplicable to the new procedure for the correction of scoliosis in children. The other staples mentioned above were not designed for spinal hemiepiphysiodesis, and are rather intended for other purposes. For example, U.S. Patent No. 4,041,939 to Hall discloses small staples to stabilize a screw-bone interconnection and to prevent the migration or grooving of a screw through a bone. Similarly, U.S. Patent No. 4,047,524 to Hall discloses a spinal clamp intended to stabilize the screw-bone interconnection of a screw and rod system. U.S. Patent No. 4,047,523 to Hall discloses a surgical sacral anchor implant that is half a staple sheet adhered to a wire for attaching the lower end of the spine. U.S. Patent No. 5,395,372 to Holt et al., Is a spinal staple that holds a bone graft type post or strut in place, and is designed for use after vertebrectomy. Thus, there is a need for an effective spinal correction system that is small and designed to encompass the growth centers of the vertebral end plate on either side of a disc. It has been known that devices such as screws or staples for the treatment of the skeletal deformity disturb or cut through the bones during normal use. More particularly, epiphyseal devices for the arrest or correction of the spinal deformity can disturb the surrounding bone according to the high loads carried by the clamping mechanism, such as a leg of the staple. This disturbance, often referred to as "grooving of the bone," occurs under physiological stresses due to the growth and movement of the joints. Bone channeling can reduce the magnitudes of force applied to the bone growth plates and can also be associated with the deformation or detachment of the device. As a staple slots through the bone it can be partially detached, such that the staple crown moves away from the bone. As the crown of the staple moves away from the bone, a greater moment is placed around the leg of the staple, which can cause the staple to deviate or flex plastically and open the legs. In both cases, the staple may come off, resulting in other potential complications. As such, there is still a need for an effective spinal correction system that reduces the likelihood of bone grooving by spreading the load over a large area of the vertebral bone.

BRIEF DESCRIPTION OF THE INVENTION A spinal correction system according to an illustrative embodiment of the present invention includes a spinal staple having a bridge member of sufficient length to encompass the vertebral end plate growth centers on either side of a disc. vertebral A pair of wedge-shaped legs spaced apart extends downwardly from the end of the bridge member and are of such a length as to penetrate no more than about half the way into the depth of a vertebra. Holding retainer portions extend horizontally outwardly from the opposite ends of the bridge member and define passageways therethrough, adapted to receive the fasteners, such as screws and the like. The retainer portions of the fastener are provided so that when two or more spinal staples of the invention are accommodated in end-to-end attached relationship, the retainer portions of the fastener that extend from the abutment ends lie side by side. The legs of the staple are equipped with beards to resist backward movement or looseness of the staple after it has been fixed to a vertebra. In addition, the retainer portions of the fastener have beards or projections that extend from a bottom surface thereof to promote fixation of the clip in a vertebra. Optionally, the staple may be provided with a cannulated, threaded post extending upwardly from the upper surface of the bridge member, to allow engagement of a cannulated, removable, threaded impact device. In addition, the additional surgical equipment can be conveniently fixed to the staple by means of a threaded post. The staple may also include anti-rotation members that extend outwardly from the legs and configured to assist in the prevention of rotational deformity. The legs of the staple have a cross-sectional area (defined by the width and length of the legs) configured to ensure adequate contact surface against the vertebrae, to compress sufficient endplate growth areas, to provide a pattern appropriate compression distribution, to prevent grooving, and to reduce joint movement. Illustratively, the cross-sectional area of the legs is at least 10% of the cross-sectional area of the respective vertebra, and the length of the legs is up to 40% of the transverse width of the respective vertebra. The ratio of the width of the leg to its length is illustratively greater than about one means to accommodate variations in the mass and size of the patient, and the cross-sectional area of the vertebrae as a function of age and vertebral level. The invention will be further described and illustrated in conjunction with the following detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES The detailed description of the figures refers particularly to the appended figures in which: Figure 1 is a perspective view of a spinal clamp according to the invention; Figure 2 is a front elevation view of the spinal clamp of Figure 1; Figure 3 is a perspective view of the spinal staple showing the lower part of the staple; Figure 4 is a top silver view of the spinal staple; Figure 5 is a view in extreme elevation of the spinal staple; Figure 6 is a perspective view of two of the spinal staples according to the invention, aligned in end-to-end attached relationship; Figure 7 is a top silver view of three of the spinal staples of the invention installed on a spine in end-to-end relationship; Figure 8 is an elevation view in partial section of a spinal correction system according to the invention, fixed to two vertebrae, to encompass two centers of growth of end plate and an intervention disc; Figure 9 is a top plan view of an alternative embodiment of the spinal clamp according to the invention; Figure 10 is a perspective view of two of the spinal staples of the alternative embodiment, aligned in an end-to-end attached relationship; Fig. 11 is a top perspective view of a spinal staple of the additional illustrative embodiment; Figure 12 is a bottom perspective view of the spinal clamp of Figure 11; Fig. 13 is a side elevation view of the spinal staple of Fig. 11; Figure 14 is a cross-sectional view taken along line 14-14 of Figure 13; Fig. 15 is a cross-sectional view showing the spinal staple of Fig. 11 installed in a vertebra; Figure 16 is a perspective view of a spinal clamp of the additional illustrative embodiment; Figure 17 is a side elevation view of the spinal clamp of Figure 16; and Figure 18 is an end view of the spinal graph of Figure 16.

DETAILED DESCRIPTION OF THE INVENTION With reference to Figures 1-6, a spinal staple constructed in accordance with an illustrative embodiment of the invention is shown. The staple 10 includes a bridge member 12, a pair of spaced legs 14, a left fastener holding portion 16, a right fastener holding portion 18 and a coupling member, illustratively a threaded post 20. Although reference will be made to Throughout this description, the terms indicating direction such as left, right, front, back or rear, or higher and lower, these terms are used solely for convenience in the description of the staple 10, and should not be considered. as limitations of the staple 10 to some particular orientation. The bridge member 12 includes an upper surface or crown 22, an opposing lower surface 24, a front side 26, an opposite rear side 28, a left side 30 and an opposite right end 32. The top surface 22 is substantially planar in one direction. direction extending from the left end 30 towards the right end 32, and is convex in a front side direction 26 towards the rear side 28, as best seen in Figure 5, when the staple 10 is observed from one of the extremes. The lower surface 24 is concave in a direction from the left end 30 towards the right end 32, and from the front side 26 towards the rear side 28, as best seen in Figures 2 and 3. The bridge member 12 defines this way a pair of cooperative arcs, a first arc extending between the left and right ends 30 and 32, and a second arc extending between the front and back sides 26 and 28, respectively.

The 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 opposing inner surface 36, such that the internal surfaces 36 are facing each other, a front surface 38, and an opposing rear surface 40. Each of the legs 14 has a width as measured from the front surface 38 towards the rear surface 40, which is substantially equal to the width of the bridge member 12 as measured from the front side 26 to the rear side 28. As shown in Figures 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 towards the inner surface 36. The legs 14 are narrowed slightly from the front surface 38 towards the rear surface 40. towards their respective tips 42 which are sharply tapering to define a blade or blade edge 43. The beards 44 project illustratively outwardly from each of the outer surfaces, in. triple, frontal and posterior, 34, 36, 38 and 40, respectively. Each beard 44 includes a retaining surface 45 generally facing away from the respective tip 42 and generally facing the bridge member 12. As such, the beards 44 are adapted to inhibit the withdrawal movement of the staple 10 a Once the staple 10 has been placed in its fixing environment, such as a vertebra. The inner surface 36 of the legs 14 are preferably extended, or angled, away from each other at an angle of about 10a to 20s as measured from a vertical plane 47 extending perpendicularly through the cross section of the bridge member 12. The external surfaces 34 of the legs 14 extend in a downward direction substantially perpendicular to the bridge member 12 and substantially parallel to the vertical plane 47. The left retainer portion 16 of the fastener extends outwardly from the end left 30 of the bridge member. The right holding portion 18 of the fastener extends outwardly from the right end 32 of the bridge member. Each of the fastener retaining portions 16, 18 defines a passageway 46 through them, adapted to receive therein, a fastener 68, such as a screw (figure 8). The retaining portions 16, 18 of the fastener, and the passageways 46 are adapted to guide a fastener 68 in a direction substantially parallel to the legs 14.

Also the fastener retaining portions 16, 18, each include front and rear sides 49 and 51 and are provided so that when two of the staples 10 are in end-to-end stop relationship as shown in Figure 6, then the retaining portions 16, 18 of the fastener extending from the stop ends are in side-by-side relation to each other. In other words, the left holding portion 16 of the fastener on a staple 10 lies along the right holding portion 18 of the fastener, of the other staple 10. In addition, the rear side 51 of the left holding portion 16 A fastener of a first staple 10 is positioned in proximity to and face the front side 49 of the right holding portion 18 of the fastener of a second adjacent staple 10. As best seen in Figure 4, a longitudinal axis 48 extends through the center of the staple 10 from the left end 30 towards the right end 32. In an illustrative embodiment, the fastener retaining portions, left and right 16, 18 lie on opposite sides of the longitudinal axis 48. In an alternative embodiment, shown in FIGS. 9 and 10, the retainer portions 16 and 18 of the fastener can extend from opposite ends of the bridge member 12, such that both portions 16 and 18 lie toward the same side of the longitudinal axis 48. In such an alternative embodiment, the staples 10 may be arranged end-to-end abutting by the adjunct staples rotatable end-to-end at 1802. Then, the portion 16 (18) left (right) of retention of the fastener of a staple 10 will lie along the left portion (18) of the staple of the attached clip 10. In addition, the back side 51 of a retaining portion 16, 18 of the fastener will be in proximity to and facing the rear side 51 of a second retainer portion 16, 18 of the fastener. Each of the retainer portions 16, 18 of the fastener includes a recess, illustratively a countersunk portion 50, adapted to receive the head of a fastener 68 therein. In addition, each retainer portion 16, 18 of the fastener also includes a lower surface 52 having a plurality of first pointed projections 54, which extend downwardly therefrom to engage the underlying bone. The second pointed projections or barbs 56 also extend downwardly from the retainer portions 16, 18 of the fastener. As shown in Figure 2, the pointed beards 56 have a longer length than the pointed projections 54 and are placed on external ends of the retaining portions 16 and 18, to resist the rotational movement of the staple 10 around its central 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 from the post 20 to the lower surface 24 of the bridge member 12. The threaded post 20 allows the coupling of physical equipment or additional instruments to the staple 10, while the passageway 58 allows the passage of a guide wire for movement along it, if desired. In addition, the cannulated threaded post 20 facilitates the engagement of a cannulated, removable, threaded impaction device. The staple 10 can be made of titanium, surgical stainless steel, or any other material that is strong enough to withstand the growth of a spinal column, to maintain sufficient mechanical fatigue properties, and that is sufficiently non-reactive in the environment of a living animal. With reference to figures 7 and 8, staples 10 are inserted into the vertebrae 60 of an animal having an immature or growing spine showing scoliosis or other spinal deformity. The staples 10 are of a size such that the legs 14 are spaced far enough apart so that the staples 10 will extend in longitudinally aligned bridge, joining the vertebrae 60 having centers of growth 62 of facing endplate, with predetermined thickness, and an intervention disk 64 between them. The staples 10 are urged towards an intermediate portion 66, between the centers of growth 62 of the end plate, of the attached vertebrae 60 on the convex side of the curved spine. The legs 14 are of such a length that they extend to the vertebrae 60 no more than half the transverse diameter of each vertebra 60, to ensure that pressure is applied only to one side of the vertebrae 60. When properly placed, the vertebrae 14 are completely embedded in the vertebrae 60, and the projections 54 and whiskers 56 of the retaining portions 16, 18 of the fastener engage the vertebral surfaces. Once a staple 10 is in place, the fasteners 68 such as screws including threaded portions, barbed stakes or the like, are inserted through the passageways 46 into the retainer portions 16, 18 of the fastener and inside the fastener portions 16, 18. the vertebrae 60. The spinal correction system, when installed on a growing spine having abnormal curvature defining a convex side and an opposite concave side, with the spine including a plurality of longitudinally attached vertebrae 60, each having a pair of centers of the extreme plate growth 62, or longitudinal growth plates, with an intermediate portion 66 therebetween, the vertebrae 60 also having a particular transverse diameter, particular width and thickness in a direction measured from the convex side to the side concave, it is widely observed to include a first means or paw 14 of bone engaging the convex side of a porc intermediate ion 66 of a first vertebra 60a at a depth of less than half the diameter of the first vertebrae 60a, a second means of engagement with the bone or leg 14 penetrating the convex side of an intermediate portion 66 of a second vertebrae 60b to a depth less than half the diameter of the second vertebra 60b, and a bridge member 12 that connects, illustratively rigidly, the first and second bone engaging means 14 (Figure 8). As can be seen, the concave bottom surface 24 of staple layer 10 substantially engages or follows the contour of the vertebral body defined by the vertebrae 60. The spinal correction system 10 thereby corrects the abnormal curve of the growing spine by inhibiting or retarding the growth of the centers of extreme plate growth 62, captured between the first and second means 14 of engaging the bone on the convex side of the spine, while allowing the unrestricted growth of the plate growth centers 62 extreme on the concave side of the spine. As the spine continues to grow, the concave side of the spine will grow faster relative to the convex side, which results in encouragement of the progression of the curve, and possibly flattening of the curvature and straightening of the spine. While the legs 14 are primarily responsible for restricting the growth of the extreme plate growth centers 62 captured therebetween, it will be noted that the retainer portions 16, 18 of the fastener and the fasteners 68 also contribute to restricting growth of the centers. of growth 62 of extreme plate captured between them. The legs 14 can even be omitted, with the proviso that the retainer portions 16, 18 of the fastener and the cooperative fasteners 68 are adapted to sufficiently resist the dispersion forces due to the longitudinal growth of the end plate growth centers 62. A spinal staple 10 'of a further exemplary embodiment is shown in Figures 11-14. Spinal staple 10 'includes many of the same characteristics as the spinal staple 10 described at the beginning. As such, in the following description, similar reference numbers are identified as similar components, as detailed with respect to the embodiment of Figures 1-10. The internal surfaces 36 of the left and right legs 14a 'and 14b' are configured to distribute the compression pressure on the centers of growth 62 of the end plate of the vertebrae 60 in a manner that retards growth unilaterally and which prevents the corrugation of the vertebrae. bone. Spinal staple 10 'is configured to induce a particular pattern of compression distribution. Factors affecting the pattern of compression distribution within the centers of extreme plate growth 62 include the length and width of the legs 14 'which jointly define the cross-sectional area of the legs 14', together with other features of the staple 10 and the placement of the layers 14 'of the vertebrae 60. The groove of the bone tends to relieve the place of therapeutic pressure on the centers 62 of growth of the end plate of the vertebrae 60, thereby allowing the disease progresses. Sufficient cross-sectional area of the legs 14 'ensures adequate contact surface against the vertebrae 60, to compress sufficient centers 62 of endplate growth, to provide an appropriate pattern of compression distribution, to prevent corrugation, and to reduce the movement of the joint. As shown in the illustrative embodiment of Figure 15, the cross-sectional area (LA) of the legs 14a 'and 14b' is at least 10% of the cross-sectional area (VA) of the first vertebra 60a and the second vertebra 60b, respectively. In an illustrative embodiment, 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). In the illustrative embodiment of Figure 14, the width (LW) of each silver 14 ', as generally measured from the front surface 38 to the back surface 40, is greater than about 6 millimeters (0.236 inches). In an illustrative embodiment, the width (LW) is between 7 millimeters (0.276 inches) and 14 millimeters (0.552 inches). In addition, as described above, the length (LL) of each leg 14 ', as measured generally from the intersection 70 of the inner surface 36 and the lower surface 24 to the tip edge 43, illustratively does not extend over one half of the vertebral diameter or the transverse width (VW Figure 15. In an illustrative embodiment, the length (LL) of each leg 14a 'and 14b' is between 10 percent and 40 percent of the transverse width (VW) of the first vertebrae 60a and the second vertebra, respectively. As such, based on the vertebral dimensions of skeletal immature children, the length (LL) of each leg 14a 'and 14b' is less than 24 millimeters (.945 inches). In an illustrative embodiment, the length (LL) is between 3 millimeters (0.118 inches) and 15 millimeters (0.59 inches).

The ratio of the width of the leg (LW) to the length (LL) can be adjusted to take into account the requirement or the size scale of the patient. In other words, in larger people a longer leg length (LL) can be adjusted. Similarly, the width (LW) must be wider to withstand a greater load relative to the patient's greater dynamic loads, muscle forces, movement forces, and vertebral / fiseal cross-sectional area. The greater the cross-sectional area of the center 62, of extreme plate growth, the greater the forces generated by the growth. Therefore, the ratio of leg width (LW) to leg length (LL) should be considered when taking into account the variation of the mass and size of the patient, and the cross-sectional area (VA) of vertebrae 60, as a function of age and vertebral level in particular. For example, the upper thoracic spine is much smaller than that of the lower thoracic spine 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 staple leg width (LW) is also important to generate the appropriate pattern of compressive tension gradient across the coronal plane of the center 62 of vertebral end plate growth , retarding or stopping the growth on the stapled side of the vertebra 60 and allowing unrestricted growth on the non-stapled side of the vertebra 60. In the illustrative embodiment, the ratio of the leg width (LW) to the length (LL) ) is greater than about one-half. In other words, the width (LW) of the staple leg 14 'is at least about 50% of its length (LL). With further reference to Figures 11-13 and 16-18, an anti-rotation member 80 is located outboard of each staple leg 14 'and abuts an adjacent fastener retention portion 16, 18. More particularly, a left anti-rotation member 80a extends between the retaining portion 16 of the left fastener and the left leg 14a, and a right anti-rotation member 80b extends between the right holding portion 18 of the fastener and the right leg 14b. The anti-rotation members 80 are placed outboard to the staple legs 14 for biting into the bone of the vertebrae 60, without cutting into the centers 62 of plate growth. The left and right anti-rotation members 80a and 80b are configured to reduce the relative rotation of the fastener retaining portions 16 and 18, left and right, 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 couple the bone to 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 can be sharpened such that it cuts into the vertebral bone. The lower edge 82 extends illustratively parallel to the longitudinal axis 48 and with upward direction of the leg 14 'towards the portion 16, 18 fastener retention, respectively. More particularly, each anti-rotation member 80 extends from the vicinity of the center of the external surface 34 of the leg 14 'to the retaining portion 16, 18 of the fastener. In the illustrative embodiment, the anti-rotation members 80 comprise triangular-shaped plates that appear as splice plates. However, it should be appreciated that the anti-rotation members 80 could be formed from 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 detach the staple 10 'from the relative rotation of the first and second vertebrae 60a and 60b bridged by the staple 10'. In addition, the anti-rotation members 80 can help prevent the bending of the legs 14 'relative to the bridge member 12, and the formation of the rotational deformity. The anti-rotation members 80 can also prevent the 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 can also reduce the likelihood of relative movement of the staple 10 'to the vertebrae 60 to improve stability. More particularly, the anti-rotation members 80 can help prevent the rotation of the staple 10 'relative to the first and second vertebrae 60a and 60b about the longitudinal axis of the spine and the shaft 74 extending through the opening 58 and the staple 10 '. Another spinal staple 100 of the illustrative embodiment is shown in Figures 16-18. Spinal staple 100 includes many of the same characteristics as spinal staples 10, 10 'described at the beginning. As such, in the following description, similar reference numbers identify similar components as detailed with respect to the modalities of Figures 1-15. The only significant distinction between the spinal staple 10 'of Figures 11, 15 and the spinal staple 100 of Figures 16-18, is that the legs 114a and 114b of the staple 100 include first and second portions 116 and 118 separated by a hollow or space 120. The reduced area of the 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. If the legs 114 are separated into individual portions 116 and 118, the collective dimensions thereof should illustratively satisfy the criteria detailed above, with respect to the legs 14 'of the staple 10'. More particularly, in order to ensure adequate contact surface against the vertebrae 60, the collective cross-sectional area (LA) of the portions 116 and 118 of each leg 114, is illustratively at least 10 percent, and in an embodiment illustrative not greater than 25 percent, of the vertebral transverse sectional area (VA) of the first vertebrae 60a and the second vertebrae 60b, respectively. In addition, the collective width (LW) of 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 the legs 114 does not extend over half of the transverse vertebral 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.

While the embodiments detailed above illustrate a simple staple 10, 10 ', 100 extending between the first and second vertebrae 60a and 60b, it should be appreciated that multiple laterally spaced staples 10, 10', 100 may be used. , the collective dimensions of the legs 14, 14 ', 114 within each vertebra 60a, 60b should illustratively satisfy the criteria detailed above with respect to the legs 14, 114 of the staple 10', 100. While the spinal correction system It is mainly intended to correct the abnormal lateral curvature of an immature or growing spine, this can also be used for spinal correction in humans that have mature or undeveloped spines. While the forms of the apparatus herein are preferred embodiments of this invention, it should be understood that the invention is not limited to these precise forms of apparatus, and that changes may be made therein without departing from the scope of the invention, which it is defined in the appended claims. It is noted that in relation to this date the best method known by the applicant to carry out the aforementioned invention is that which is clear from the present description of the invention.

Claims (34)

CLAIMS Having described the invention as above, the contents of the following claims are claimed as property:

1. A spinal staple, characterized in that it comprises: a bridge member having a top surface, an opposite bottom surface, a front side, an opposite back side, a left end, and an opposite right end; a left part extending from the lower surface of the bridge member near the left end to a tip configured to be inserted into a first vertebra, the left leg includes an external surface, an opposite internal surface, a front surface and a surface opposite posterior; the left leg further includes a width measured from the front surface to the rear surface and a length measured from the intersection of the inner surface of the left leg and the lower surface of the bridge member towards the tip, the width of the left leg being greater than about 6 millimeters and at least half the length of the left leg; a right leg extending from the undersurface of the bridge member near the right end to a tip configured to be inserted into a second vertebra, the left leg includes an outer surface, an opposing inner surface, a front surface, and a opposite posterior surface; and the right leg further includes a width measured from the front surface to the back surface and a length measured from the intersection of the inner surface of the right leg and the bottom surface of the bridge member toward the tip, the width of the right leg is greater than about 6 millimeters and at least half the length of the right leg 2.

The spinal clamp according to claim 1, characterized in that the first and second vertebra each include, predetermined transverse widths, the length of the leg Left is less than half the transverse width of the first vertebra, and the length of the right leg is less than half the transverse width of the second vertebra.

The spinal clamp according to claim 2, characterized in that the length of the left leg is not greater than 40 percent of the transverse width of the first vertebra, and the length of the right leg is not greater than 40 percent of the second vertebra.

4. The spinal clamp according to claim 1, characterized in that: the first and second vertebrae each include transverse sectional areas; the left leg includes a cross-sectional area extending from the front surface to the rear surface, the cross-sectional cross-sectional area being between 10 percent and 25 percent of the cross-sectional area to the first vertebra; and the right leg includes a cross-sectional area extending from the front surface to the rear surface, the cross-sectional cross-sectional area being between 10 percent and 25 percent of the cross-sectional area to the second vertebra.

5. The spinal clamp according to claim 1, characterized in that it further comprises: a left retaining portion of the fastener extending from the left end of the bridge member; a right holding portion of the fastener extending from the right end of the bridge member; a left fastener extending within the left hold portion of the fastener and configured to be inserted within the first vertebra; and a right bra that extends within the right hold portion of the clip and configured to be inserted into the second vertebra.

The spinal clamp according to claim 1, characterized in that it further comprises a passageway extending through the bridge member from the upper surface to the lower surface, the passageway is configured to receive a guide wire to guide the movement of the bridge member along the guide wire.

The spinal clamp according to claim 1, characterized in that the internal surfaces of the left leg and the right leg are extended outwardly away from each other as measured from a plane passing between the left leg and the right leg, substantially perpendicular to the bridge member.

8. A spinal correction system configured for use in a growing spine having abnormal curvature defining a convex side, the spine includes a plurality of first and second vertebrae attached longitudinally, each vertebra includes centers of growth of end plate with a intermediate portion between them, a transverse width and a transverse sectional area, the spinal correction system is characterized in that it comprises: at least one bridge member that includes a top surface, an opposite bottom surface, a front side, an opposite back side, a left end and an opposite right end; at least one left leg coupled to at least one bridge member and including a tip configured to be inserted into a first vertebra, each of at least the left leg includes an external surface, an opposite internal surface, a front surface, an opposing back surface, a width measured from the front surface towards the back surface, a length measured from the intersection of the inner surface of at least one left leg and the bottom surface of the bridge member toward the tip, and a sectional area cross section extending from the front surface towards the rear surface; the length of each of at least one left leg that is no greater than 40 percent of the transverse width of the first vertebra; the collective transverse sectional area of the internal surface of at least one left leg that is at least 10 percent of the cross-sectional area of the first vertebra; at least one right leg coupled to the bridge member and including a tip configured to be inserted into a second vertebra, each of at least one right leg includes an external surface, an opposite internal surface, a front surface, a rear surface opposite, a width measured from the front surface towards the back surface, a length measured from the intersection of the inner surface of at least one right leg and the bridge member from the bottom surface to the tip, and a cross sectional area that is extends from the front surface to the rear surface; the length of each of at least one right leg that is no greater than 40 percent of the transverse width of the first vertebra; and the collective transverse sectional area of the internal surface of at least one right leg is at least 10 percent of the cross-sectional area of the second vertebra.

The spinal correction system according to claim 8, characterized in that at least one left leg includes an individual left leg and at least one right leg includes an individual right leg.

The spinal correction system according to claim 8, characterized in that at least one left leg includes first and second left legs, and at least one right leg includes first and second right legs.

The spinal correction system according to claim 8, characterized in that: the collective width of at least one left leg is at least one half of the average length of at least one left leg; and the collective width of at least one right leg is at least a half of the average length of at least one right leg.

The spinal correction system according to claim 8, characterized in that it further comprises: a left holding portion of the fastener extending from each of at least one left end of the bridge member; a right holding portion of the fastener extending from each of at least one right end of the bridge member; a left fastener extending within each left hold portion of the fastener and configured to be inserted within the first vertebra; and a right bra that extends within each right hold portion of the clip and configured to be inserted into the second vertebra.

13. The spinal correction system according to claim 8, characterized in that the internal surfaces of at least one left leg and at least one right leg are extended outwardly as measured from a plane passing between the left leg and the leg right, substantially perpendicular to at least one bridge member.

14. The spinal correction system configured for use in a growing spine having abnormal curvature defining a convex side, the spine includes a plurality of longitudinally attached vertebrae, each vertebra includes centers of extreme plate growth with an intermediate portion between these, a transverse width and a cross-sectional area, the spinal correction system is characterized in that it comprises: at least one bridge member that includes a top surface, an opposite bottom surface, a front side, an opposite rear side, an end left and an opposite right end; at least one left leg including a tip configured to be inserted into a first vertebra, each of the left leg includes an external surface, an opposing inner surface, a front surface and an opposing posterior surface; each of at least the left leg further includes a width measured from the front surface towards the back surface, and a length measured from the section of the inner surface of at least one left leg and the bottom surface of the bridge member towards the tip; the collective width of at least one left leg is greater than a half of the average length of at least one left leg; at least one right leg includes a tip configured to be inserted into a second vertebra, each of at least one right leg includes an outer surface, an opposing inner surface, a front surface and an opposing posterior surface; each of at least the right leg further includes a width measured from the front surface to the back surface, and a length measured from the intersection of the inner surface of at least one right leg and the bottom surface of the bridge member toward the tip; the collective width of at least one right leg is greater than a half of the average length of at least one right leg; each of at least one left leg includes a transverse sectional area extending from the front surface to the back surface, the collective transverse sectional area of the at least one left leg being substantially between 10 percent and 25 percent of the cross sectional area of the first vertebra; and each of at least one right leg includes a transverse sectional area extending from the front surface to the rear surface, the collective transverse sectional area of the at least one right leg is substantially between 10 percent and 25 percent of the sectional area cross section of the second vertebra.

15. The spinal correction system according to claim 14, characterized in that at least one left leg includes an individual left leg and at least one right leg includes a right leg invidual.

16. The spinal correction system according to claim 14, characterized in that at least one left leg includes first and second left legs and at least one right leg includes first and second right legs.

17. The spinal correction system according to claim 14, characterized in that: the collective width of at least one left leg is greater than about 6 millimeters; and the collective width of at least one right leg is greater than about 6 millimeters 18.

The spinal correction system according to claim 14, characterized in that the length of each of at least one left leg is not greater than 40 percent. of the transverse width of the first vertebra, and the length of the right leg is no greater than 40 percent of the transverse width of the second vertebra.

The spinal correction system according to claim 14, characterized in that the internal surfaces of each of at least one left leg and at least one right leg are extended outwardly as measured from a plane passing between minus one left leg and at least one right leg, substantially perpendicular to the bridge member.

20. A spinal correction system configured for use on a growing spine having an abnormal curvature defining a convex side, the spine includes a plurality of longitudinally attached vertebrae, each vertebra including centers of extreme plate growth with an intermediate portion between them, a transverse width and a cross sectional area, the spinal correction system is characterized in that it comprises: at least one bridge member that includes a top surface, an opposite bottom surface, a front side, an opposite rear side, an end left and one opposite right end; at least one left leg extends from the bottom surface of each of at least one bridge member near the left end to a tip configured to be inserted into a first vertebra, each of at least one left leg including an outer surface , an opposing inner surface, a front surface, and an opposing back surface, each of at least one left leg further includes a width measured from the front surface to the back surface, and a length measured from the intersection of the inner surface of at least one left leg and the bottom surface of at least one bridge member toward the tip; the collective width of at least one left leg is greater than about 6 millimeters and the length of each of at least one left leg is less than about 24 millimeters; a right leg extends from the bottom surface of each of at least one bridge member near the right end toward a tip configured to be inserted from a second vertebra, each of at least one right leg includes an outer surface, a opposite inner surface, a front surface, and an opposing back surface, each of at least one right leg further includes a width measured from the front surface to the rear surface, and a length measured from the intersection of the inner surface of the minus one right leg, and the bottom surface of at least one bridge member toward the tip; and the collective width of at least one right leg is greater than about 6 millimeters and the length of each of at least one right leg is less than about 24 millimeters.

21. The spinal correction system according to claim 20, characterized in that: the collective width of at least one left leg is between 7 millimeters and 14 millimeters, and the length of each of at least one left leg is between 3 millimeters and 15 millimeters; and the collective width of at least one right leg is between 7 millimeters and 14 millimeters, and the length of each of at least one right leg is between about 3 millimeters and 15 millimeters.

22. The spinal correction system according to claim 20, characterized in that: the collective width of at least one left leg is at least one half of the average length of at least one left leg; and the collective width of at least one right leg is at least a half of the average length of at least one right leg.

23. The spinal correction system according to claim 20, characterized in that the length of each of at least one left leg is not greater than 40 percent of the transverse width of the first vertebra, and the length of each of at least one right leg is no greater than 40 percent of the transverse width of the second vertebra.

24. The spinal correction system according to claim 20, characterized in that: each of at least one left leg includes a transverse sectional area extending from the front surface toward the posterior surface, the collective transverse sectional area of at least one left leg is between 10 percent and 25 percent of the cross sectional area of the first vertebra; and each of at least one right leg includes a transverse sectional area extending from the front surface to the rear surface, the collective cross sectional area of at least one right leg is between 10 percent and 25 percent of the cross sectional area of the second vertebra.

25. The spinal correction system according to claim 20, characterized in that it further comprises: a left retaining portion of the fastener extending from the left end of each of at least one bridge member; a right hold portion of the fastener extending from the right end of each of at least one bridge member; a left fastener extending within the left hold portion of the fastener and configured to be inserted within the first vertebra; and a right bra that extends into the right hold portion of the clip and configured to be inserted into the second vertebra.

26. The spinal correction system according to claim 20, characterized in that the internal surfaces of each of at least one left leg and the right leg are extended outwardly as measured from a plane passing between at least one left leg and right leg, substantially perpendicular to at least one bridge member.

27. A spinal staple, characterized in that it comprises: a bridge member extending along a longitudinal axis and having the upper surface; an opposite lower surface, a front side, an opposite rear side, a left end and an opposite right end; a left holding portion of the fastener extending from the left end of the bridge member; a left fastener extending within the left hold portion of the fastener and configured to be inserted into a first vertebra; a right holding portion of the fastener extending from the right end of the bridge member; a right fastener extending within the right hold portion of the fastener and configured to be inserted into a second vertebra; a left leg extending from the lower surface of the bridge member near the left end and including a tip configured to be inserted into a first vertebra, the left leg further includes an external surface, an opposite internal surface, a front surface and an opposite posterior surface; a right leg extending from the undersurface of the bridge member near the right end and including a tip configured to be inserted into a second vertebra, the right leg further includes an outer surface, an opposite inner surface, a front surface and an opposite posterior surface; a left anti-rotation member extending between the left holding portion of the fastener and the right portion, the left anti-rotation member is configured to reduce the relative rotation of the left holding portion of the fastener about the longitudinal axis with respect to to the first vertebra; and a right anti-rotation member extending between the right holding portion of the fastener and the right portion, the right anti-rotation member is configured to reduce the relative rotation of the right holding portion of the fastener about the longitudinal axis with relationship to the second vertebra.

The spinal clamp according to claim 27, characterized in that the left anti-rotation member includes a lower edge configured to engage the first vertebra, and the right anti-rotation member includes a lower edge configured to engage the second vertebra.

29. The spinal clamp according to claim 28, characterized in that the lower edge of the left anti-rotation member extends in an upward direction from the left leg to the left fastener holding portion, and the lower edge of the right anti-rotation member. -rotation extends in an upward direction from the right leg to the right hold-down portion of the fastener.

30. The spinal clamp according to claim 27, characterized in that the left anti-rotation member and the right anti-rotation member extend parallel to the longitudinal axis.

31. The spinal clamp according to claim 27, characterized in that the left anti-rotation member extends outwardly from the vicinity of a center of the outer surface of the left leg, and the right anti-rotation member extends. with outward direction close to a center of the outer surface of the right leg.

32. The spinal clamp according to claim 27, characterized in that the anti-rotation members increase the load required to detach the staple from the relative rotation of the first and second vertebrae bridged by the staple.

33. The spinal clamp according to claim 27, characterized in that: the left leg includes a width measured from the front surface towards the posterior surface, and a length measured from the intersection of the inner surface of the left leg and the lower surface from the middle of the bridge to the tip, the width of the left leg is at least half the length of the left leg; and the right leg includes a width measured from the front surface towards the rear surface, and a length measured from the intersection of the inner surface of the right leg and the bottom surface of the bridge means towards the tip, the width of the right leg it is at least a half of the length of the right leg.

34. The spinal clamp according to claim 33, characterized in that the width of the left leg is greater than 6 millimeters and the width of the right leg is greater than 6 millimeters.