US20100286730A1 - Implant for correction of spinal deformity - Google Patents
Implant for correction of spinal deformity Download PDFInfo
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- US20100286730A1 US20100286730A1 US12/779,258 US77925810A US2010286730A1 US 20100286730 A1 US20100286730 A1 US 20100286730A1 US 77925810 A US77925810 A US 77925810A US 2010286730 A1 US2010286730 A1 US 2010286730A1
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- Prior art keywords
- end portion
- tension
- tension member
- cable
- implant
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- 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
- A61B17/7055—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant connected to sacrum, pelvis or skull
-
- 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
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7014—Longitudinal elements, e.g. rods with means for adjusting the distance between two screws or hooks
- A61B17/7016—Longitudinal elements, e.g. rods with means for adjusting the distance between two screws or hooks electric or electromagnetic means
-
- 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
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
- A61B17/7022—Tethers, i.e. longitudinal elements capable of transmitting tension only, e.g. straps, sutures or cables
-
- 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
- A61B17/7053—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
Definitions
- the present invention generally relates to a device for treatment of spine disorders, and in particular to the utilization of an implant to impose a corrective displacement on a vertebra of a patient so as to incrementally correct abnormal spinal curvature(s) of the patient.
- Scoliosis is a spinal deformity that has an abnormal lateral curvature of the spine when viewed from a posterior perspective.
- the abnormal curvature of the spine is commonly associated with abnormal spinal rotation causing ribs to protrude posteriorly into what is commonly referred to as “rib hump”.
- the scoliosis is classified with infantile scoliosis and adolescent idiopathic scoliosis.
- the adolescent idiopathic scoliosis is the most prevalent type of scoliosis which develops during adolescence in an otherwise healthy patient and typically ceases at the onset of skeletal maturity. The cause of the disease is presently unknown.
- a flaw in the conventional implants for correction of the spinal curvature deformity is that the implants are usually of a part of the load path of the spinal column.
- the Cotel-Dubousset system rigidly attaches stiff stainless steel rods to the spine.
- the stiffest member for transmission of a load. Therefore, loads exerted on an instrumented spine are transferred through the implant instead of through the spine.
- Spinal loads could be large, and the geometry of the implants used is such that they may not support such large loads indefinitely. Fatigue failure of the implant occurs if fusion is delayed.
- a further disadvantage of the conventional implants for correction of the spinal curvature deformity is the potential for neurologic damage. It has been shown that loads required for correction of the spinal curvature deformity during the surgery warrant concern for spinal cord trauma. For this reason, nerve functions are usually monitored during the surgery. Even after the surgery, the spinal loads could be large enough to cause nerve damages.
- viscoelastic properties of the spinal structures including the intervertebral discs, ligaments, nerves, muscles and other connective tissues have a time-dependent relationship between force and displacement: the stiffness of viscoelastic structures decreases with time under action of a sustained force. Stress-relaxation and creep are manifestations of viscoelasticity. The creep is gradual displacements under the action of the sustained force, while the stress-relaxation is gradual reductions of an internal force (resistance) under the action of an imposed displacement. It has been shown that dramatic stress-relaxation occurs within minutes of spinal curvature correction procedures. However, stiff instrumentation provides negligible additional correction even though resistive forces in the spine are decreasing.
- the present invention relates to a device for correction of a spinal deformity.
- the device includes a cable having a first end portion, and an opposite, second end portion, and a tension member having a cylindrical magnet, a leadscrew and a body.
- the leadscrew has a helically threaded exterior surface, an interior surface defining a bore for housing the cylindrical magnet rigidly, an axis therethrough the bore, a first end and an opposite, second end, and a length, L 2 , defined therebetween.
- the body has a first end portion and an opposite, second end portion defining a cylindrical chamber therebetween, a longitudinal axis therethrough the cylindrical chamber, a U-shape cut formed in the first end portion, and a length, L 1 , defined therebetween the first end portion and the second end portion, where L 1 >L 2 .
- the cylindrical chamber has a first chamber portion and a second chamber portion neighboring to the first chamber portion. The first chamber portion and the second chamber portion are sized with a diameter, d 1 , and d 2 , respectively, where d 2 >d 1 such that a step is formed at the junction of the first chamber portion and the second chamber portion.
- the first chamber portion is helically threaded for engaging with the leadscrew such that when the leadscrew is received in the cylindrical chamber, the axis of the leadscrew is substantially coincident with the longitudinal axis of the body and the leadscrew is capable of moving back and forth along the longitudinal axis as being rotated around the longitudinal axis.
- the tension member further has a first cap and a second cap attached to the first end and the second end of the leadscrew, respectively.
- the second cap is sized to fit the second chamber portion of the cylindrical chamber such that as assembled, the second cap prevents the leadscrew from moving out of the cylindrical chamber of the body of the tension member.
- the device includes a shackle.
- the shackle is formed in a clevis-shape and has a first end portion, a second end portion and a body portion defined therebetween, where in use the first end portion and the second end portion are secured to a pelvic bone, and the body portion is received in the U-shape cut of the body of the tension member such that the tension member is capable of rotating around a first axis and a second axis perpendicular to the first axis, respectively.
- the first axis and the second axis are perpendicular to the axis of the body of the tension member.
- the device includes a first engaging member mechanically engaging the first end portion of the cable with the tension member.
- the first engaging member includes a ball-and-socket joint mechanism.
- the first engaging member has a swaged ball attached to the first end portion of the cable, and a pivot cap having a shoulder and a hole formed on the shoulder. As assembled, the first end portion of the cable is received through the hole of the pivot cap and the pivot cap is attached to the first end cap of the tension member such that the swaged ball articulates with the shoulder of the pivot cap, and thus rotating the leadscrew around its axis does not cause the cable to rotate and twist.
- the device includes a second engaging member arranged, in use, mechanically engaging the second end portion of the cable with a vertebra such that the tension of the cable is adjustable for imposing a corrective displacement on the vertebra.
- the second engaging member has a bone screw having a screw head, at least one spherical recess formed on the screw head, a hole formed through the at least one spherical recess, and a body portion having helical threads for threading into the vertebra, a ball having a hole formed therethrough, and a crimp.
- the second end portion of the cable is received through the hole in the bone screw and the hole formed in the ball, respectively, and secured by the crimp such that a change in angulation between the tension member and the vertebra is accommodated by articulation of the ball with the spherical recess.
- the second end portion of the cable is formed with a loop portion
- the second engaging member has a pair of bone screws attached to the vertebra, a rod connected the pair of bone screws, and a crimp. As assembled, the loop portion of the second end portion of the cable engages with the rod and is secured with the crimp.
- the device also includes means for rotating the leadscrew of the tension member around the axis of the body of the tension member.
- the rotating means comprises an actuator.
- the actuator has a first axle and a second axle each having a first end and a second end, a first pulley and a second pulley mounted onto the second end of the first axle and the second end of the second axle, respectively, a cylindrical magnet magnetized diametrically and symmetrically formed on the second axle, a crank attached to the first end of the first axle such that when a torque is applied to the crank to cause the first axle to rotate, a torque is simultaneously applied to the first pulley, and a belt engaging with the first pulley and the second pulley for transferring torques from the first pulley to the second pulley so as to rotate the cylindrical magnet.
- the actuator is positioned such that when the cylindrical magnet of the actuator rotates, a magnetic filed generated by the cylindrical magnet of the actuator causes the cylindrical magnet of the tension member to rotate, which in turn causes the leadscrew of the tension member to rotate so as to cause the tension member to move from a first state to a second state that is different from the first state.
- the first state of the tension member is characterized by an angle, ⁇ , of the axis of the body of the tension member relative to a horizontal axis
- the second state of the tension member is characterized by an angle, ⁇ , of the axis of the body of the tension member relative to the horizontal axis, wherein 0 ⁇ /2, 0 ⁇ /2, and ⁇ .
- the cable is made of a biocompatible material.
- the biocompatible material includes a polymer, a composite, a metal, an alloy, or any combination thereof.
- the cable is coated with a material to reduce abrasion and adhesion of biologic tissues.
- the present invention relates to a device for correction of a spinal deformity.
- the device includes a cable having a first end portion, and an opposite, second end portion, a tension member, a first engaging member mechanically engaging the first end portion of the cable with the tension member, a second engaging member mechanically engaging the second end portion of the cable with a vertebra, and a third engaging member mechanically engaging the tension member with a pelvic bone.
- the tension member has a leadscrew which has a head, a shank extending from the head, and a threaded portion extending from the shank.
- the tension member further has a one-way clutch coupled with the shank such that when rotating in one of the clockwise and counterclockwise directions, the one-way clutch engages with the shank, and when rotating in the other of the clockwise and counterclockwise directions, the one-way clutch freewheels on the shank.
- the tension member also has a body having an interior surface complementarily threaded for receiving the leadscrew, an axis, a first end portion, an opposite, second end portion, and a U-shape cut and a hole formed in the second end portion, where the hole of the body has an axis perpendicular to the axis. Additionally, the tension member has a toggle.
- the toggle in one embodiment, has a first end portion and an opposite, second end portion defining a chamber therebetween for housing the one-way clutch rigidly, a pair of wings radially protruding from the second end portion, and a hole formed on the first end portion.
- the first engaging member includes a ball-and-socket joint mechanism.
- the first engaging member has a swaged ball attached to the first end portion of the cable, and a pivot cap having a shoulder and a hole formed on the shoulder.
- the first end portion of the cable is received through the hole of the pivot cap and the pivot cap is attached to the head of the leadscrew of the tension member such that the swaged ball articulates with the shoulder of the pivot cap, and thus rotating the leadscrew around its axis does not cause the cable to rotate and twist.
- the first end portion of the cable is formed with a loop portion, and the first engaging member has a pin, and a crimp. As assembled, the loop portion of the first end portion of the cable engages with the pin and is secured with the crimp.
- the second engaging member in one embodiment, has a bone screw having a screw head, at least one spherical recess formed on the screw head, a hole formed through the at least one spherical recess, and a body portion having helical threads for threading into the vertebra, a ball having a hole formed therethrough, and a crimp.
- the second end portion of the cable is received through the hole in the bone screw and the hole formed in the ball, respectively, and secured by the crimp such that a change in angulation between the tension member and the vertebra is accommodated by articulation of the ball with the spherical recess.
- the second end portion of the cable is formed with a loop portion
- the second engaging member comprises a pair of bone screws attached to the vertebra, a rod connected with the pair of bone screws, and a crimp. As assembled, the loop portion of the second end portion of the cable engages with the rod and is secured with the crimp.
- the third engaging member includes a clevis-shape shackle.
- the clevis-shape shackle in one embodiment has a first end portion, a second end portion and a body portion defined therebetween, where in use the first end portion and the second end portion are secured to the pelvic bone, and the body portion is received in the U-shape cut of the body of the tension member and secured by placing a pin into the hole of the body of the tension member such that the tension member is capable of rotating around a first axis and a second axis, respectively.
- the first axis is substantially coincident with the axis of the hole of the body of the tension member, and wherein the second axis is perpendicular to the first axis and the axis of the body of the tension member, respectively.
- the one-way clutch rotates alternately in the clockwise and counterclockwise directions thereby causing the leadscrew to rotatably advance into the body so as to cause the tension member to move from a first state to a second state that is different from the first state, whereby the tension of the cable is adjustable for imposing a corrective displacement on the vertebra.
- the first state of the tension member is characterized by an angle, ⁇ , of the axis of the body of the tension member relative to a horizontal axis
- the second state of the tension member is characterized by an angle, ⁇ , of the axis of the body of the tension member relative to the horizontal axis, wherein 0 ⁇ /2, 0 ⁇ /2, and ⁇ .
- the present invention relates to a device for correction of a spinal deformity.
- the device includes a cable having a first end portion, and an opposite, second end portion attachable to a vertebra, means for adjusting the tension of the cable so as to impose a corrective displacement on the vertebra, and means for attaching the body to a pelvic bone.
- the adjusting means comprise a screw having a threaded portion and engaged with the first end portion of the cable, and a body having an interior surface complementarily threaded for receiving the screw such that when the screw rotatably advances into the body, the tension of the cable is adjusted.
- the present invention relates to a device for correction of a spinal deformity.
- the device includes a tension adjusting member having a first end, a second end, and a body defined therebetween the first end and the second end.
- the device further includes a tension member having a first end portion, a second end portion and a body portion defined therebetween the first end portion and the second end portion, and movably engaged with the body of the tension adjusting member such that the first end portion of the tension member is movable relative to the first end of the tension adjusting member for adjusting the tension of the tension member.
- the second end portion of the tension member is to be secured to a vertebra and the first end of the tension adjusting member is to be secured to a pelvic bone so that when the first end portion of the tension member moves away from or toward to the first end of the tension adjusting member, the tension of the tension member is adjusted so as to impose a corrective displacement on the vertebra.
- FIG. 1 a shows schematically a posterior view of a scoliotic human spine with an implanted device according to one embodiment of the present invention
- FIG. 1 b shows schematically a posterior view of a corrected human spine with the implanted device shown in FIG. 1 b;
- FIG. 2 shows a perspective exploded view of a device according to one embodiment of the present invention
- FIG. 3 shows a perspective view of the device shown in FIG. 2 ;
- FIG. 4 shows a sectioned view of the device shown in FIG. 2 in an extended configuration
- FIG. 5 shows a sectioned view of the device shown in FIG. 2 in a collapsed configuration
- FIG. 6 shows a perspective exploded view of a second engaging member according to one embodiment of the present invention.
- FIG. 7 shows a perspective view of the second engaging member shown in FIG. 6 ;
- FIG. 8 shows a perspective view of an actuator and a device according to one embodiment of the present invention.
- FIG. 9 shows a side view of the actuator and the device shown in FIG. 8 ;
- FIG. 10 is a cross-sectional view of the actuator and the device shown in FIG. 8 , showing magnetic flux lines;
- FIG. 11 shows schematically a posterior view of a scoliotic human spine with an implanted device according to another embodiment of the present invention
- FIG. 12 is a perspective view of an alternative embodiment of the second engaging member
- FIG. 13 is a perspective view of a device according to another embodiment of the present invention.
- FIG. 14 is a perspective exploded view of the device shown in FIG. 13 ;
- FIG. 15 shows a sectioned view of the device shown in FIG. 13 in an extended configuration
- FIG. 16 shows a sectioned view of the device shown in FIG. 13 in a collapsed configuration
- this invention in one aspect, relates to an implant for a surgical correction of abnormal spinal curvatures by imposing corrective displacements on abnormal spinal vertebras.
- the present invention is described with specific reference to scoliosis.
- the present invention disclosed herein is generally applicable to all classifications of spinal curvature disorders, including lordosis and kyphosis in the spine.
- FIG. 1 a a posterior view of a scoliotic spine 104 of a patient having an abnormal spinal curvature is shown schematically, where a device (implant) 200 is attached to a pelvic bone 102 and a vertebra 100 of the patient, respectively, according to one embodiment of the present invention.
- the invented device 200 includes a tension member 201 , a cable 204 having a first end portion 204 a and an opposite, second end portion 204 b, a first engaging member 207 mechanically engaging the first end portion 204 a of the cable 204 with the tension member 201 , a second engaging member 209 mechanically engaging the second end portion 204 b of the cable 204 with the vertebra 100 , and a shackle 202 mechanically engaging the tension member 201 with the pelvic bone 102 .
- the tension of the cable 204 is adjustable for imposing a corrective displacement on the vertebra 100 to correct the abnormal spinal curvature of the patient.
- the shackle 202 is mounted to the pelvic bone 102 with a shackle clevis screw 210 .
- the second engaging member 209 has a bone screw 412 and a ball 404 adapted for securing the second end portion 204 b of the cable 204 to the vertebra 100 .
- the tension member 201 forms an initial angle, ⁇ , relative to a horizontal plane 105 , hence defining an initial distance (length), L, between a first end 201 a of the tension member 201 and the bone screw 412 , where 0 ⁇ /2.
- FIG. 1 b shows a posterior view of the spine 104 of the patient after correction of the abnormal spinal curvature with the implanted device 200 .
- the angle between the tension member 201 and the horizontal plane 105 is indicated by ⁇ , where 0 ⁇ /2, and ⁇ .
- ⁇ the angle between the tension member 201 and the horizontal plane 105
- L′ the distance between the first end 201 a of the tension member 201 and the bone screw 412 has been changed from L to L′.
- L′ may be greater or less than L. In the embodiment shown in FIG. 1 b, L′ ⁇ L.
- device 200 is shown to have the tension member 201 , the cable 204 , the first engaging member 207 and the second engaging member 209 , and the third engaging member 202 according to one embodiment of the present invention.
- the cable 204 has a first end portion 204 a and an opposite, second end portion 204 b .
- the tension member 201 has a cylindrical magnet 220 magnetized diametrically.
- the cylindrical magnet 220 has a first semi-cylindrical portion and an opposite, second semi-cylindrical portion.
- the first semi-cylindrical portion and the second semi-cylindrical portion of the cylindrical magnet 220 are magnetized as a north pole, N, and a south pole, S, respectively, as shown in FIG. 8 .
- the tension member 201 further has a leadscrew 218 .
- the leadscrew 218 has a helically threaded exterior surface 218 a and an, interior surface 218 b, a first end 218 d and an opposite, second end 218 e, a cylindrical bore 234 defined by the interior surface 218 b and between the first end 218 d and the second end 218 e, an axis 218 c therethrough the cylindrical bore 234 , and a length, L 2 , defined by the first end 218 d and the second end 218 e .
- the cylindrical bore 234 is adapted for housing the cylindrical magnet 220 rigidly.
- the cylindrical magnet 220 and the leadscrew 218 are fixedly engaged such that the cylindrical magnet 220 does not rotate relative to the leadscrew 218 in operation.
- the engagement of the cylindrical magnet 220 with the leadscrew 218 is implemented by an anti-rotation means, for example, an adhesive or a mechanical interlock (not shown).
- an anti-rotation means for example, an adhesive or a mechanical interlock (not shown).
- the first end 218 d and the second end 218 e of the leadscrew 218 are hermetically sealed by a first cap 216 and a second cap 222 , respectively.
- the sealing process in one embodiment, is performed with a laser welding. Other sealing methods can also be used to practice the present invention.
- the tension member 201 also includes a body 203 .
- the body 203 has a first end portion 203 a and an opposite, second end portion 203 b defining a cylindrical chamber 229 therebetween, a longitudinal axis 203 c therethrough the cylindrical chamber 229 , a U-shape cut 203 d formed in the second end portion 203 b, and a length, L 1 , defined between the first end portion 229 a and the second end portion.
- L 1 >L 2 .
- the cylindrical chamber 229 has a first chamber portion 229 a and a second chamber portion 229 b neighboring to the first chamber portion 229 a.
- the first chamber portion 229 a and the second chamber portion 229 b are sized with a diameter, d 1 , and d 2 , respectively. In one embodiment, d 2 >d 1 , and thus a step 229 c is formed at the junction of the first chamber portion 229 a and the second chamber portion 229 b . In one embodiment, the first chamber portion 229 a is helically threaded for engaging with the leadscrew 218 .
- the axis 218 c of the leadscrew 218 is substantially coincident with the axis 203 c of the body 203 , and the leadscrew 218 is capable of moving back and forth along the axis 203 c of the body 203 as being rotated around the axis 203 c of the body 203 of the tension member 201 .
- the second cap is sized to fit the second chamber portion 229 b of the cylindrical chamber 229 such that as assembled, the second cap prevents the leadscrew 218 from moving out of the cylindrical chamber 229 of the body 203 of the tension member 201 .
- the second end cap maintains concentricity with and therefore alignment of the leadscrew 218 relative to the body 203 of the tension member 201 .
- the first engaging member 207 mechanically engages the first end portion 204 a of the cable 204 with the tension member 201 .
- the first engaging member 207 has a ball-and-socket joint mechanism in which a swaged ball 214 is fixedly attached to the first end portion 204 a of the cable 204 .
- the first engaging member 207 further has a pivot cap 208 that has a shoulder 215 , in which a hole 213 is formed.
- the first end portion 204 a of the cable 204 attached to the swaged ball 214 is received through the hole 213 of the pivot cap 208 and the pivot cap 208 is then fixedly attached to the first end cap 216 of the tension member 201 by welding or other attaching means.
- the swaged ball 214 articulates with the shoulder 215 of the pivot cap 208 , and thus rotating the leadscrew 218 around its axis 218 c does not cause the cable 204 to rotate and twist.
- the second engaging member 209 for mechanically engaging the second end portion 204 b of the cable 204 with the vertebra 100 in one embodiment, as shown in FIGS. 6 and 7 , includes a bone screw 402 having a screw head 412 , two spherical recesses 408 formed on two sides of the screw head 412 , respectively, a hole 410 formed through the two spherical recesses 408 , and a body portion 414 having helical threads for threading into the vertebra 100 , a ball 404 having a hole formed therethrough, and a crimp 406 .
- the second end portion 204 b of the cable 204 is received through the hole 410 in the bone screw 402 and the hole formed in the ball 404 , respectively, and secured by the crimp 406 such that a change in angulation between the tension member 201 and the vertebra 100 is accommodated by articulation of the ball 404 with the spherical recess 408 .
- the second engaging member 409 has a pair of bone screws 602 attached to the vertebra 100 , a rod 610 engaged with the pair of bone screws 602 , and a crimp 606 .
- the bone screws 602 has a polyaxial screw head 603 and a helical threaded body 608 extending from the polyaxial screw head 603 .
- a loop portion 600 formed in the second end portion 204 b of the cable 204 engages with the rod 610 and is secured with the crimp 606 .
- the rod 610 is secured to the pair of bone screws 602 by threading a pair of screw caps 604 into the polyaxial screw heads 603 of the pair of the bone screws 602 , respectively.
- the use of multiple bone screws enhances fixation of the device 200 to the spine 204 .
- the third engaging member 202 for mechanically engaging the tension member 201 with the pelvic bone 102 in one embodiment includes a shackle 202 .
- the shackle 202 is formed in a clevis-shape and has a first end portion 202 a, a second end portion 202 b and a body portion 202 c defined therebetween.
- Holes 205 and 226 are formed in the first end portion 202 a and the second end portion 202 b, respectively.
- one of the holes 205 and 226 is helically threaded for receiving a clevis screw 210 .
- the body portion 202 c is received in the U-shape cut 203 d of the body 203 of the tension member 201 and secured by placing a pin 206 into a hole 224 formed in the second end portion 203 b of the body 203 of the tension member 201 .
- the tension member 201 is not rigidly attached to the shackle 202 , but is capable of rotating around a first axis 230 and a second axis 232 perpendicular to the first axis 230 , respectively.
- the first axis 230 is substantially coincident with an axis 230 of the hole 224 in the body 203 of the tension member 201 .
- the first axis 230 , the second axis 232 and the axis 203 c of the body 203 of the tension member 201 are perpendicular to each other.
- the shackle 202 allows the tension element 201 to rotationally orient itself to a relatively straight path toward the spinal attachment site and causes changes in angulation of the tension element 201 relative to the horizontal plane 105 as indicated by angles ⁇ and ⁇ in FIGS. 1 a and 1 b , respectively.
- the first end portion 202 a and the second end portion 202 b are secured to the pelvic bone 102 . As shown in FIGS.
- a hole is drilled into the pelvic bone 102 , the clevis screw 210 is then fed through a hole 205 formed on the first end portion 202 a and the hole drilled in the pelvic bone 102 , and threaded into a threaded shackle hole 226 formed in the second end portion 202 b to secure the shackle 202 to the pelvis bone 102 .
- the device 200 also includes means for rotating the leadscrew 218 of the tension member 201 around the axis 203 c of the body 203 of the tension member 201 .
- the rotating means includes an actuator.
- actuator 300 has a first axle 314 and a second axle 316 parallelly attached to a frame 320 that has a support flange 310 .
- Each of the first axle 314 and the second axle 316 has a first end and a second end.
- the actuator 300 further has a first pulley 312 a and a second pulley 312 b rigidly mounted onto the second end of the first axle 314 and the second end of the second axle 316 , respectively.
- the actuator 300 also has a cylindrical magnet 302 magnetized diametrically and symmetrically formed on the second axle 316 . As shown in FIG. 8 , the cylindrical magnet 302 has a north pole, N, and a south pole, S. Additionally, the actuator 300 has a crank 306 that is fixedly attached to the first end of the first axle 314 such that when a torque is applied to the crank 306 to cause the first axle 314 to rotate, a torque is simultaneously applied to the first pulley 312 a.
- the actuator 300 has a belt 308 engaging with the first pulley 312 a and the second pulley 312 b for transferring torques from the first pulley 312 a to the second pulley 312 b so as to rotate the cylindrical magnet 302 .
- the flange 310 of the actuator 300 is placed against the external surface of a patient's skin in the vicinity of the tension member 201 , which is implanted beneath the patient's skin.
- the cylindrical magnet 302 of the actuator 300 rotationally aligns the cylindrical magnet 220 of the tension member 201 such that the north poles N of the cylindrical magnet 302 of the actuator 300 and the cylindrical magnet 220 of the tension member 201 are in the same direction.
- the cylindrical magnet 302 of the actuator 300 rotates, a magnetic field generated by the cylindrical magnet 302 of the actuator 300 causes the cylindrical magnet 220 of the tension member 201 to rotate, which in turn causes the leadscrew 218 of the tension member 201 to rotate so as to cause the tension member 201 to move from a first state to a second state that is different from the first state.
- the first state and the second state are corresponding to an extended configuration and a collapsed configuration of the tension member 201 , as shown in FIGS. 4 and 5 , respectively.
- the first state of the tension member 201 is characterized by an angle, ⁇ , of the axis 203 c of the body 203 relative to a horizontal axis
- the second state of the tension member 201 is characterized by an angle, ⁇ , of the axis 203 c of the body 203 of the tension member 201 relative to the horizontal axis, wherein 0 ⁇ /2, 0 ⁇ /2, and ⁇ , as shown in FIGS. 1 a and 1 b.
- crank 306 when the crank 306 is rotated in a direction 330 , it causes the leadscrew 218 of the tension member 201 rotatably to advance into the body 203 of the tension member 201 , which pulls the cable 204 into the body 203 of the tension member 201 in a direction arrow 250 , as shown in FIG. 8 . Therefore, the rotation of the crank 306 indirectly causes change or here reduction of the length L. Conversely, rotation of the crank 306 in the opposite direction increases length L.
- FIG. 9 shows a side view of the actuator 300 and the cylindrical magnet 220 of the tension member 201 .
- FIG. 10 shows a cross-sectional view of the cylindrical magnet 302 of the actuator 300 and the cylindrical magnet 220 of the tension member 201 having magnet flux lines 500 and 502 , respectively.
- the device 700 which utilizes a toggle mechanism for correction of a spinal deformity, is shown according to an alternative embodiment of the present invention.
- the device 700 includes a cables 704 , a tension member 701 , a first engaging member for mechanically engaging the cable 704 with the tension member 701 , and a shackle 202 for mechanically engaging the tension member 701 with a pelvic bone.
- the tension member 701 has a leadscrew 718 that has a head 708 , a shank 710 extending from the head 708 , and a threaded portion 712 extending from the shank 710 .
- the tension member 701 further has a one-way clutch 714 coupled with the shank 710 .
- the one-way clutch 714 is configured such that when rotating in one of the clockwise and counterclockwise directions, the one-way clutch 714 engages with the shank 710 , and when rotating in the other of the clockwise and counterclockwise directions, the one-way clutch 714 freewheels on the shank 710 .
- the tension member 701 also has a body 703 , which has an interior surface complementarily threaded for receiving the leadscrew 718 , a first end portion 703 a, an opposite, second end portion 703 b, an axis 703 c, a U-shape cut 703 d and a hole 703 e formed in the second end portion 703 b, where the hole 703 e has an axis 730 perpendicular to the axis 703 c. Additionally, the tension member 701 has a toggle 702 .
- the toggle 702 in one embodiment, has a first end portion 702 a and an opposite, second end portion 702 b defining a chamber 729 therebetween for housing the one-way clutch 714 rigidly, a pair of wings 705 radially protruding from the second end portion 702 b, and a hole 715 formed on the first end portion 702 a.
- the first engaging member has a pin 716 , and a crimp 706 .
- loop portion 738 formed in the first end portion 704 a of the cable 704 engages with the pin 716 and is secured with the crimp 706 .
- the first engaging member in another embodiment includes a ball-and-socket joint mechanism.
- the device 700 also includes a second engaging member for mechanically engaging the cable 704 with a vertebra (not shown).
- the second engaging member is capable of accommodating changes in the rotational orientation of the cable as curvature is corrected.
- the shackle 202 mechanically engages the tension member 701 with a pelvic bone, according to the procedures as described above.
- Other engaging means of the tension member 701 with the pelvic bone can also be used to practice the present invention.
- the one-way clutch 714 rotates alternately in the clockwise and counterclockwise directions thereby causing the leadscrew 718 to rotatably advance into the body 703 , which in turn pulls the cable 704 into the body 703 of the tension member 701 , whereby the tension of the cable 204 is adjustable for imposing a corrective displacement on the vertebra 100 .
- This operation causes the tension member 201 to move from a first state to a second state that is different from the first state.
- the first state and the second state are corresponding to an extended configuration and a collapsed configuration of the tension member 701 , as shown in FIGS. 15 and 16 , respectively.
- the present invention relates to a device for correction of a spinal deformity.
- the device includes a cable having a first end portion 204 a, and an opposite, second end portion 204 b attachable to a vertebra 100 , means for adjusting the tension of the cable so as to impose a corrective displacement on the vertebra 100 , and means for attaching the body to a pelvic bone 102 .
- the adjusting means comprise a screw having a threaded portion and engaged with the first end portion of the cable, and a body having an interior surface complementarily threaded for receiving the screw such that when the screw rotatably advances into the body, the tension of the cable is adjusted.
- the adjusting means includes a magnet driving mechanism, a toggle driving mechanism, a hydraulic driving mechanism, or the likes.
- the cable is made of a biocompatible material.
- the biocompatible material comprises a polymer, a composite, a metal, an alloy, or any combination thereof.
- the cable is coated with a material to reduce abrasion and adhesion of biologic tissues.
- the present invention relates to a device for correction of a spinal deformity.
- the device includes a tension adjusting member having a first end, a second end, and a body defined therebetween the first end and the second end.
- the device further includes a tension member having a first end portion, a second end portion and a body portion defined therebetween the first end portion and the second end portion, and movably engaged with the body of the tension adjusting member such that the first end portion of the tension member is movable away from the first end of the tension adjusting member for adjusting the tension of the tension member.
- the second end portion of the tension member is to be secured to a vertebra 100 and the first end of the tension adjusting member is to be secured to a pelvic bone 102 so that when the first end portion of the tension member is movable away from or toward to the first end of the tension adjusting member, the tension of the tension member is adjusted so as to impose a corrective displacement on the vertebra 100 .
- a surgical procedure for implantation of the invented device includes the following steps: at first, a device having a tension member, a cable engaging with the tension member, and a shackle engaging with the tension member is provided according to one embodiment of the present invention. Then openings at a pelvis bone and a spinal attachment site are incised, respectively. A small hole is drilled through the pelvis bone at a pre-selected position, possibly at or near the iliac crest. The shackle is then secured to the pelvis bone with a screw, clamp or pin. Next, the cable is attached to the spinal attachment site through the openings with an engaging member including bone screws. Once the device is implanted, the wounds are closed and correction of the spinal deformity is performed incrementally and non-invasively according to the procedures as described above.
- the present invention discloses a non-invasive or minimal invasive device (implant) for correcting abnormal spinal curvatures of a patient.
- One of advantages of the present invention is the potential to correct the abnormal spinal curvatures without spinal fusion. Permanent correction of the abnormal spinal curvatures is achieved by gradually realigning the spinal column so that force imbalances in the spine no longer exist. In certain cases, the onset of skeletal maturity marks the end of curve progression due to the fact that the supporting structures of the spinal column have reacted to the abnormal spinal curvature and imbalances are eliminated. However, in extreme cases of scoliosis the spinal deformity exceeds a critical point and equilibrium may not be reached and therefore the curve progression continues even after the skeletal maturity.
Abstract
A device for correction of a spinal deformity includes an implant having a first end portion and an opposite second end portion, the first end portion being attachable to an extraspinal bone, the second end portion being attachable to a vertebra, the implant being configured for being adjusted without penetrating skin and thereby for adjusting a tension of the implant so as to impose a corrective displacement on the vertebra.
Description
- This is a continuation of U.S. patent application Ser. No. 11/215,725, entitled “IMPLANT FOR CORRECTION OF SPINAL DEFORMITY”, filed Aug. 30, 2005, which is incorporated herein by reference. U.S. patent application Ser. No. 11/215,725 is a non-provisional application based upon U.S. provisional patent application Ser. No. 60/605,548, entitled “IMPLANT FOR CORRECTION OF SPINAL DEFORMITY”, filed Aug. 30, 2004, which is incorporated herein by reference.
- 1. Field of the Invention
- The present invention generally relates to a device for treatment of spine disorders, and in particular to the utilization of an implant to impose a corrective displacement on a vertebra of a patient so as to incrementally correct abnormal spinal curvature(s) of the patient.
- 2. Description of the Related Art
- Scoliosis is a spinal deformity that has an abnormal lateral curvature of the spine when viewed from a posterior perspective. The abnormal curvature of the spine is commonly associated with abnormal spinal rotation causing ribs to protrude posteriorly into what is commonly referred to as “rib hump”. The scoliosis is classified with infantile scoliosis and adolescent idiopathic scoliosis. The adolescent idiopathic scoliosis is the most prevalent type of scoliosis which develops during adolescence in an otherwise healthy patient and typically ceases at the onset of skeletal maturity. The cause of the disease is presently unknown.
- Currently, surgical treatments of a spinal curvature deformity involve manipulation of the spinal column by attaching a correction device and then fusion of the spine. One such system, used primarily for scoliosis, is the Cotel-Dubousset system, as disclosed in U.S. Pat. No. 5,147,360 to Dubousset, which is understood to the use of rigidly attaching metal rods to the spine with plates and screws. The metal rods are then manipulated during the surgical procedure in an attempt to straighten the abnormal curvatures and reduce the rotation of the spinal column. The spine is then fused with a bone graft, typically requiring extensive discectomies, removal of spinous processes as the bone graft harvest, and injury to the spine itself to induce bleeding for improving the bone fusion. It is believed that the surgery is arduous, invasive, and has an array of potential complications including excessive blood loss. The discs above and below the fusion zone are in jeopardy of degeneration due to the increased biomechanical demands placed on them. Also, flat back syndrome could be problematic if normal lordosis and kyphosis are not restored. Recovery could be a lengthy and painful process. Even a successful procedure rarely results in a normal spinal curvature and the patient is left with an immobile spinal section.
- A flaw in the conventional implants for correction of the spinal curvature deformity is that the implants are usually of a part of the load path of the spinal column. For example, it is understood that the Cotel-Dubousset system rigidly attaches stiff stainless steel rods to the spine. For a structure having two members placed in parallel, it relies primarily on the stiffest member for transmission of a load. Therefore, loads exerted on an instrumented spine are transferred through the implant instead of through the spine. Spinal loads could be large, and the geometry of the implants used is such that they may not support such large loads indefinitely. Fatigue failure of the implant occurs if fusion is delayed.
- A further disadvantage of the conventional implants for correction of the spinal curvature deformity is the potential for neurologic damage. It has been shown that loads required for correction of the spinal curvature deformity during the surgery warrant concern for spinal cord trauma. For this reason, nerve functions are usually monitored during the surgery. Even after the surgery, the spinal loads could be large enough to cause nerve damages.
- Additionally, viscoelastic properties of the spinal structures including the intervertebral discs, ligaments, nerves, muscles and other connective tissues have a time-dependent relationship between force and displacement: the stiffness of viscoelastic structures decreases with time under action of a sustained force. Stress-relaxation and creep are manifestations of viscoelasticity. The creep is gradual displacements under the action of the sustained force, while the stress-relaxation is gradual reductions of an internal force (resistance) under the action of an imposed displacement. It has been shown that dramatic stress-relaxation occurs within minutes of spinal curvature correction procedures. However, stiff instrumentation provides negligible additional correction even though resistive forces in the spine are decreasing.
- Therefore, a heretofore unaddressed need exists in the art to address the aforementioned deficiencies and inadequacies.
- In one aspect, the present invention relates to a device for correction of a spinal deformity. In one embodiment, the device includes a cable having a first end portion, and an opposite, second end portion, and a tension member having a cylindrical magnet, a leadscrew and a body. In one embodiment, the leadscrew has a helically threaded exterior surface, an interior surface defining a bore for housing the cylindrical magnet rigidly, an axis therethrough the bore, a first end and an opposite, second end, and a length, L2, defined therebetween. The body has a first end portion and an opposite, second end portion defining a cylindrical chamber therebetween, a longitudinal axis therethrough the cylindrical chamber, a U-shape cut formed in the first end portion, and a length, L1, defined therebetween the first end portion and the second end portion, where L1>L2. In one embodiment, the cylindrical chamber has a first chamber portion and a second chamber portion neighboring to the first chamber portion. The first chamber portion and the second chamber portion are sized with a diameter, d1, and d2, respectively, where d2>d1 such that a step is formed at the junction of the first chamber portion and the second chamber portion. The first chamber portion is helically threaded for engaging with the leadscrew such that when the leadscrew is received in the cylindrical chamber, the axis of the leadscrew is substantially coincident with the longitudinal axis of the body and the leadscrew is capable of moving back and forth along the longitudinal axis as being rotated around the longitudinal axis. In one embodiment, the tension member further has a first cap and a second cap attached to the first end and the second end of the leadscrew, respectively. The second cap is sized to fit the second chamber portion of the cylindrical chamber such that as assembled, the second cap prevents the leadscrew from moving out of the cylindrical chamber of the body of the tension member.
- Furthermore, the device includes a shackle. In one embodiment, the shackle is formed in a clevis-shape and has a first end portion, a second end portion and a body portion defined therebetween, where in use the first end portion and the second end portion are secured to a pelvic bone, and the body portion is received in the U-shape cut of the body of the tension member such that the tension member is capable of rotating around a first axis and a second axis perpendicular to the first axis, respectively. In one embodiment, the first axis and the second axis are perpendicular to the axis of the body of the tension member.
- Moreover, the device includes a first engaging member mechanically engaging the first end portion of the cable with the tension member. In one embodiment, the first engaging member includes a ball-and-socket joint mechanism. The first engaging member has a swaged ball attached to the first end portion of the cable, and a pivot cap having a shoulder and a hole formed on the shoulder. As assembled, the first end portion of the cable is received through the hole of the pivot cap and the pivot cap is attached to the first end cap of the tension member such that the swaged ball articulates with the shoulder of the pivot cap, and thus rotating the leadscrew around its axis does not cause the cable to rotate and twist.
- Additionally, the device includes a second engaging member arranged, in use, mechanically engaging the second end portion of the cable with a vertebra such that the tension of the cable is adjustable for imposing a corrective displacement on the vertebra. In one embodiment the second engaging member has a bone screw having a screw head, at least one spherical recess formed on the screw head, a hole formed through the at least one spherical recess, and a body portion having helical threads for threading into the vertebra, a ball having a hole formed therethrough, and a crimp. As assembled, the second end portion of the cable is received through the hole in the bone screw and the hole formed in the ball, respectively, and secured by the crimp such that a change in angulation between the tension member and the vertebra is accommodated by articulation of the ball with the spherical recess. In another embodiment, the second end portion of the cable is formed with a loop portion, and the second engaging member has a pair of bone screws attached to the vertebra, a rod connected the pair of bone screws, and a crimp. As assembled, the loop portion of the second end portion of the cable engages with the rod and is secured with the crimp.
- The device also includes means for rotating the leadscrew of the tension member around the axis of the body of the tension member. In one embodiment, the rotating means comprises an actuator. The actuator has a first axle and a second axle each having a first end and a second end, a first pulley and a second pulley mounted onto the second end of the first axle and the second end of the second axle, respectively, a cylindrical magnet magnetized diametrically and symmetrically formed on the second axle, a crank attached to the first end of the first axle such that when a torque is applied to the crank to cause the first axle to rotate, a torque is simultaneously applied to the first pulley, and a belt engaging with the first pulley and the second pulley for transferring torques from the first pulley to the second pulley so as to rotate the cylindrical magnet.
- In operation, the actuator is positioned such that when the cylindrical magnet of the actuator rotates, a magnetic filed generated by the cylindrical magnet of the actuator causes the cylindrical magnet of the tension member to rotate, which in turn causes the leadscrew of the tension member to rotate so as to cause the tension member to move from a first state to a second state that is different from the first state. In one embodiment, the first state of the tension member is characterized by an angle, α, of the axis of the body of the tension member relative to a horizontal axis, and the second state of the tension member is characterized by an angle, β, of the axis of the body of the tension member relative to the horizontal axis, wherein 0≦α<π/2, 0≦β<π/2, and β≠α.
- In one embodiment, the cable is made of a biocompatible material. The biocompatible material includes a polymer, a composite, a metal, an alloy, or any combination thereof. In one embodiment, the cable is coated with a material to reduce abrasion and adhesion of biologic tissues.
- In another aspect, the present invention relates to a device for correction of a spinal deformity. In one embodiment, the device includes a cable having a first end portion, and an opposite, second end portion, a tension member, a first engaging member mechanically engaging the first end portion of the cable with the tension member, a second engaging member mechanically engaging the second end portion of the cable with a vertebra, and a third engaging member mechanically engaging the tension member with a pelvic bone.
- In one embodiment, the tension member has a leadscrew which has a head, a shank extending from the head, and a threaded portion extending from the shank. The tension member further has a one-way clutch coupled with the shank such that when rotating in one of the clockwise and counterclockwise directions, the one-way clutch engages with the shank, and when rotating in the other of the clockwise and counterclockwise directions, the one-way clutch freewheels on the shank. The tension member also has a body having an interior surface complementarily threaded for receiving the leadscrew, an axis, a first end portion, an opposite, second end portion, and a U-shape cut and a hole formed in the second end portion, where the hole of the body has an axis perpendicular to the axis. Additionally, the tension member has a toggle. The toggle, in one embodiment, has a first end portion and an opposite, second end portion defining a chamber therebetween for housing the one-way clutch rigidly, a pair of wings radially protruding from the second end portion, and a hole formed on the first end portion.
- In one embodiment, the first engaging member includes a ball-and-socket joint mechanism. The first engaging member has a swaged ball attached to the first end portion of the cable, and a pivot cap having a shoulder and a hole formed on the shoulder. As assembled, the first end portion of the cable is received through the hole of the pivot cap and the pivot cap is attached to the head of the leadscrew of the tension member such that the swaged ball articulates with the shoulder of the pivot cap, and thus rotating the leadscrew around its axis does not cause the cable to rotate and twist. In another embodiment, the first end portion of the cable is formed with a loop portion, and the first engaging member has a pin, and a crimp. As assembled, the loop portion of the first end portion of the cable engages with the pin and is secured with the crimp.
- The second engaging member in one embodiment, has a bone screw having a screw head, at least one spherical recess formed on the screw head, a hole formed through the at least one spherical recess, and a body portion having helical threads for threading into the vertebra, a ball having a hole formed therethrough, and a crimp. As assembled, the second end portion of the cable is received through the hole in the bone screw and the hole formed in the ball, respectively, and secured by the crimp such that a change in angulation between the tension member and the vertebra is accommodated by articulation of the ball with the spherical recess. In another embodiment, the second end portion of the cable is formed with a loop portion, and the second engaging member comprises a pair of bone screws attached to the vertebra, a rod connected with the pair of bone screws, and a crimp. As assembled, the loop portion of the second end portion of the cable engages with the rod and is secured with the crimp.
- In one embodiment, the third engaging member includes a clevis-shape shackle. The clevis-shape shackle in one embodiment has a first end portion, a second end portion and a body portion defined therebetween, where in use the first end portion and the second end portion are secured to the pelvic bone, and the body portion is received in the U-shape cut of the body of the tension member and secured by placing a pin into the hole of the body of the tension member such that the tension member is capable of rotating around a first axis and a second axis, respectively. In one embodiment, the first axis is substantially coincident with the axis of the hole of the body of the tension member, and wherein the second axis is perpendicular to the first axis and the axis of the body of the tension member, respectively.
- In operation, by pressing alternately on each of the pair of wings of the toggle of the tension member, the one-way clutch rotates alternately in the clockwise and counterclockwise directions thereby causing the leadscrew to rotatably advance into the body so as to cause the tension member to move from a first state to a second state that is different from the first state, whereby the tension of the cable is adjustable for imposing a corrective displacement on the vertebra. In one embodiment, the first state of the tension member is characterized by an angle, α, of the axis of the body of the tension member relative to a horizontal axis, and the second state of the tension member is characterized by an angle, β, of the axis of the body of the tension member relative to the horizontal axis, wherein 0≦α<π/2, 0≦β<π/2, and β≠α.
- In yet another aspect, the present invention relates to a device for correction of a spinal deformity. In one embodiment, the device includes a cable having a first end portion, and an opposite, second end portion attachable to a vertebra, means for adjusting the tension of the cable so as to impose a corrective displacement on the vertebra, and means for attaching the body to a pelvic bone. In one embodiment, the adjusting means comprise a screw having a threaded portion and engaged with the first end portion of the cable, and a body having an interior surface complementarily threaded for receiving the screw such that when the screw rotatably advances into the body, the tension of the cable is adjusted.
- In yet a further aspect, the present invention relates to a device for correction of a spinal deformity. In one embodiment, the device includes a tension adjusting member having a first end, a second end, and a body defined therebetween the first end and the second end. The device further includes a tension member having a first end portion, a second end portion and a body portion defined therebetween the first end portion and the second end portion, and movably engaged with the body of the tension adjusting member such that the first end portion of the tension member is movable relative to the first end of the tension adjusting member for adjusting the tension of the tension member. In use, the second end portion of the tension member is to be secured to a vertebra and the first end of the tension adjusting member is to be secured to a pelvic bone so that when the first end portion of the tension member moves away from or toward to the first end of the tension adjusting member, the tension of the tension member is adjusted so as to impose a corrective displacement on the vertebra.
- These and other aspects of the present invention will become apparent from the following description of the preferred embodiment taken in conjunction with the following drawings, although variations and modifications therein may be affected without departing from the spirit and scope of the novel concepts of the disclosure.
- The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
-
FIG. 1 a shows schematically a posterior view of a scoliotic human spine with an implanted device according to one embodiment of the present invention; -
FIG. 1 b shows schematically a posterior view of a corrected human spine with the implanted device shown inFIG. 1 b; -
FIG. 2 shows a perspective exploded view of a device according to one embodiment of the present invention; -
FIG. 3 shows a perspective view of the device shown inFIG. 2 ; -
FIG. 4 shows a sectioned view of the device shown inFIG. 2 in an extended configuration; -
FIG. 5 shows a sectioned view of the device shown inFIG. 2 in a collapsed configuration; -
FIG. 6 shows a perspective exploded view of a second engaging member according to one embodiment of the present invention; -
FIG. 7 shows a perspective view of the second engaging member shown inFIG. 6 ; -
FIG. 8 shows a perspective view of an actuator and a device according to one embodiment of the present invention; -
FIG. 9 shows a side view of the actuator and the device shown inFIG. 8 ; -
FIG. 10 is a cross-sectional view of the actuator and the device shown inFIG. 8 , showing magnetic flux lines; -
FIG. 11 shows schematically a posterior view of a scoliotic human spine with an implanted device according to another embodiment of the present invention; -
FIG. 12 is a perspective view of an alternative embodiment of the second engaging member; -
FIG. 13 is a perspective view of a device according to another embodiment of the present invention; -
FIG. 14 is a perspective exploded view of the device shown inFIG. 13 ; -
FIG. 15 shows a sectioned view of the device shown inFIG. 13 in an extended configuration; and -
FIG. 16 shows a sectioned view of the device shown inFIG. 13 in a collapsed configuration; - Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
- The present invention is more particularly described in the following examples that are intended as illustrative only since numerous modifications and variations therein will be apparent to those skilled in the art. Various embodiments of the invention are now described in detail. Referring to the drawings, like numbers indicate like parts throughout the views. As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein and throughout the claims that follow, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
- The description will be made as to the embodiments of the present invention in conjunction with the accompanying drawings 1-16. In accordance with the purposes of this invention, as embodied and broadly described herein, this invention, in one aspect, relates to an implant for a surgical correction of abnormal spinal curvatures by imposing corrective displacements on abnormal spinal vertebras. For ease of understanding, the present invention is described with specific reference to scoliosis. However, the present invention disclosed herein is generally applicable to all classifications of spinal curvature disorders, including lordosis and kyphosis in the spine.
- Referring to
FIG. 1 a, a posterior view of ascoliotic spine 104 of a patient having an abnormal spinal curvature is shown schematically, where a device (implant) 200 is attached to apelvic bone 102 and avertebra 100 of the patient, respectively, according to one embodiment of the present invention. The inventeddevice 200, as described in details below, includes atension member 201, acable 204 having afirst end portion 204 a and an opposite,second end portion 204 b, a first engagingmember 207 mechanically engaging thefirst end portion 204 a of thecable 204 with thetension member 201, a second engagingmember 209 mechanically engaging thesecond end portion 204 b of thecable 204 with thevertebra 100, and ashackle 202 mechanically engaging thetension member 201 with thepelvic bone 102. The tension of thecable 204 is adjustable for imposing a corrective displacement on thevertebra 100 to correct the abnormal spinal curvature of the patient. Theshackle 202 is mounted to thepelvic bone 102 with ashackle clevis screw 210. In one embodiment, the second engagingmember 209 has abone screw 412 and aball 404 adapted for securing thesecond end portion 204 b of thecable 204 to thevertebra 100. As implanted in relation to apelvic bone 102 and avertebra 100, thetension member 201 forms an initial angle, α, relative to ahorizontal plane 105, hence defining an initial distance (length), L, between afirst end 201 a of thetension member 201 and thebone screw 412, where 0≦α<π/2. -
FIG. 1 b shows a posterior view of thespine 104 of the patient after correction of the abnormal spinal curvature with the implanteddevice 200. As shown inFIG. 1 b, after the correction, the angle between thetension member 201 and thehorizontal plane 105 is indicated by β, where 0≦β<π/2, and β≠α. In this exemplary embodiment, β<α. The distance between thefirst end 201 a of thetension member 201 and thebone screw 412 has been changed from L to L′. L′ may be greater or less than L. In the embodiment shown inFIG. 1 b, L′<L. - Referring now to
FIGS. 2-12 and first toFIGS. 2 and 3 ,device 200 is shown to have thetension member 201, thecable 204, the first engagingmember 207 and the second engagingmember 209, and the third engagingmember 202 according to one embodiment of the present invention. Thecable 204 has afirst end portion 204 a and an opposite,second end portion 204 b. Thetension member 201 has acylindrical magnet 220 magnetized diametrically. In one embodiment, thecylindrical magnet 220 has a first semi-cylindrical portion and an opposite, second semi-cylindrical portion. The first semi-cylindrical portion and the second semi-cylindrical portion of thecylindrical magnet 220 are magnetized as a north pole, N, and a south pole, S, respectively, as shown inFIG. 8 . - The
tension member 201 further has aleadscrew 218. In one embodiment, theleadscrew 218 has a helically threadedexterior surface 218 a and an,interior surface 218 b, afirst end 218 d and an opposite,second end 218 e, acylindrical bore 234 defined by theinterior surface 218 b and between thefirst end 218 d and thesecond end 218 e, anaxis 218 c therethrough thecylindrical bore 234, and a length, L2, defined by thefirst end 218 d and thesecond end 218 e. Thecylindrical bore 234 is adapted for housing thecylindrical magnet 220 rigidly. As assembled, thecylindrical magnet 220 and theleadscrew 218 are fixedly engaged such that thecylindrical magnet 220 does not rotate relative to theleadscrew 218 in operation. In one embodiment, the engagement of thecylindrical magnet 220 with theleadscrew 218 is implemented by an anti-rotation means, for example, an adhesive or a mechanical interlock (not shown). After thecylindrical magnet 220 is received into thecylindrical bore 234 of theleadscrew 218, thefirst end 218 d and thesecond end 218 e of theleadscrew 218 are hermetically sealed by afirst cap 216 and asecond cap 222, respectively. The sealing process, in one embodiment, is performed with a laser welding. Other sealing methods can also be used to practice the present invention. - The
tension member 201 also includes abody 203. Thebody 203 has afirst end portion 203 a and an opposite,second end portion 203 b defining a cylindrical chamber 229 therebetween, alongitudinal axis 203 c therethrough the cylindrical chamber 229, aU-shape cut 203 d formed in thesecond end portion 203 b, and a length, L1, defined between thefirst end portion 229 a and the second end portion. In one embodiment, L1>L2. The cylindrical chamber 229 has afirst chamber portion 229 a and asecond chamber portion 229 b neighboring to thefirst chamber portion 229 a. Thefirst chamber portion 229 a and thesecond chamber portion 229 b are sized with a diameter, d1, and d2, respectively. In one embodiment, d2>d1, and thus astep 229 c is formed at the junction of thefirst chamber portion 229 a and thesecond chamber portion 229 b. In one embodiment, thefirst chamber portion 229 a is helically threaded for engaging with theleadscrew 218. When theleadscrew 218 is received in the cylindrical chamber 229, theaxis 218 c of theleadscrew 218 is substantially coincident with theaxis 203 c of thebody 203, and theleadscrew 218 is capable of moving back and forth along theaxis 203 c of thebody 203 as being rotated around theaxis 203 c of thebody 203 of thetension member 201. In one embodiment, the second cap is sized to fit thesecond chamber portion 229 b of the cylindrical chamber 229 such that as assembled, the second cap prevents the leadscrew 218 from moving out of the cylindrical chamber 229 of thebody 203 of thetension member 201. The second end cap maintains concentricity with and therefore alignment of theleadscrew 218 relative to thebody 203 of thetension member 201. - The first engaging
member 207 mechanically engages thefirst end portion 204 a of thecable 204 with thetension member 201. In one embodiment as shown inFIG. 2 , the first engagingmember 207 has a ball-and-socket joint mechanism in which a swagedball 214 is fixedly attached to thefirst end portion 204 a of thecable 204. The first engagingmember 207 further has apivot cap 208 that has ashoulder 215, in which ahole 213 is formed. As assembled, thefirst end portion 204 a of thecable 204 attached to the swagedball 214 is received through thehole 213 of thepivot cap 208 and thepivot cap 208 is then fixedly attached to thefirst end cap 216 of thetension member 201 by welding or other attaching means. In this embodiment, the swagedball 214 articulates with theshoulder 215 of thepivot cap 208, and thus rotating theleadscrew 218 around itsaxis 218 c does not cause thecable 204 to rotate and twist. - The second engaging
member 209 for mechanically engaging thesecond end portion 204 b of thecable 204 with thevertebra 100, in one embodiment, as shown inFIGS. 6 and 7 , includes abone screw 402 having ascrew head 412, twospherical recesses 408 formed on two sides of thescrew head 412, respectively, ahole 410 formed through the twospherical recesses 408, and abody portion 414 having helical threads for threading into thevertebra 100, aball 404 having a hole formed therethrough, and acrimp 406. As assembled, thesecond end portion 204 b of thecable 204 is received through thehole 410 in thebone screw 402 and the hole formed in theball 404, respectively, and secured by thecrimp 406 such that a change in angulation between thetension member 201 and thevertebra 100 is accommodated by articulation of theball 404 with thespherical recess 408. - In another embodiment, as shown in
FIGS. 11 and 12 , the second engagingmember 409 has a pair of bone screws 602 attached to thevertebra 100, arod 610 engaged with the pair of bone screws 602, and acrimp 606. The bone screws 602 has apolyaxial screw head 603 and a helical threadedbody 608 extending from thepolyaxial screw head 603. As assembled, aloop portion 600 formed in thesecond end portion 204 b of thecable 204 engages with therod 610 and is secured with thecrimp 606. In one embodiment, therod 610 is secured to the pair of bone screws 602 by threading a pair ofscrew caps 604 into the polyaxial screw heads 603 of the pair of the bone screws 602, respectively. The use of multiple bone screws enhances fixation of thedevice 200 to thespine 204. - The third engaging
member 202 for mechanically engaging thetension member 201 with thepelvic bone 102 in one embodiment includes ashackle 202. As shown inFIGS. 2-5 , theshackle 202 is formed in a clevis-shape and has afirst end portion 202 a, asecond end portion 202 b and abody portion 202 c defined therebetween.Holes first end portion 202 a and thesecond end portion 202 b, respectively. In one embodiment, one of theholes clevis screw 210. Thebody portion 202 c is received in theU-shape cut 203 d of thebody 203 of thetension member 201 and secured by placing apin 206 into ahole 224 formed in thesecond end portion 203 b of thebody 203 of thetension member 201. Thetension member 201 is not rigidly attached to theshackle 202, but is capable of rotating around afirst axis 230 and asecond axis 232 perpendicular to thefirst axis 230, respectively. In one embodiment, thefirst axis 230 is substantially coincident with anaxis 230 of thehole 224 in thebody 203 of thetension member 201. Thefirst axis 230, thesecond axis 232 and theaxis 203 c of thebody 203 of thetension member 201 are perpendicular to each other. In this embodiment, theshackle 202 allows thetension element 201 to rotationally orient itself to a relatively straight path toward the spinal attachment site and causes changes in angulation of thetension element 201 relative to thehorizontal plane 105 as indicated by angles α and β inFIGS. 1 a and 1 b, respectively. In one embodiment, thefirst end portion 202 a and thesecond end portion 202 b are secured to thepelvic bone 102. As shown inFIGS. 1 a and 1 b, a hole is drilled into thepelvic bone 102, theclevis screw 210 is then fed through ahole 205 formed on thefirst end portion 202 a and the hole drilled in thepelvic bone 102, and threaded into a threadedshackle hole 226 formed in thesecond end portion 202 b to secure theshackle 202 to thepelvis bone 102. - The
device 200 also includes means for rotating theleadscrew 218 of thetension member 201 around theaxis 203 c of thebody 203 of thetension member 201. In one embodiment, the rotating means includes an actuator. As shown inFIG. 8 ,actuator 300 has afirst axle 314 and asecond axle 316 parallelly attached to aframe 320 that has asupport flange 310. Each of thefirst axle 314 and thesecond axle 316 has a first end and a second end. Theactuator 300 further has a first pulley 312 a and asecond pulley 312 b rigidly mounted onto the second end of thefirst axle 314 and the second end of thesecond axle 316, respectively. Theactuator 300 also has acylindrical magnet 302 magnetized diametrically and symmetrically formed on thesecond axle 316. As shown inFIG. 8 , thecylindrical magnet 302 has a north pole, N, and a south pole, S. Additionally, theactuator 300 has acrank 306 that is fixedly attached to the first end of thefirst axle 314 such that when a torque is applied to the crank 306 to cause thefirst axle 314 to rotate, a torque is simultaneously applied to the first pulley 312 a. Moreover, theactuator 300 has abelt 308 engaging with the first pulley 312 a and thesecond pulley 312 b for transferring torques from the first pulley 312 a to thesecond pulley 312 b so as to rotate thecylindrical magnet 302. - In operation, the
flange 310 of theactuator 300 is placed against the external surface of a patient's skin in the vicinity of thetension member 201, which is implanted beneath the patient's skin. As shown inFIG. 8 , thecylindrical magnet 302 of theactuator 300 rotationally aligns thecylindrical magnet 220 of thetension member 201 such that the north poles N of thecylindrical magnet 302 of theactuator 300 and thecylindrical magnet 220 of thetension member 201 are in the same direction. When thecylindrical magnet 302 of theactuator 300 rotates, a magnetic field generated by thecylindrical magnet 302 of theactuator 300 causes thecylindrical magnet 220 of thetension member 201 to rotate, which in turn causes theleadscrew 218 of thetension member 201 to rotate so as to cause thetension member 201 to move from a first state to a second state that is different from the first state. In one embodiment, the first state and the second state are corresponding to an extended configuration and a collapsed configuration of thetension member 201, as shown inFIGS. 4 and 5 , respectively. The first state of thetension member 201 is characterized by an angle, α, of theaxis 203 c of thebody 203 relative to a horizontal axis, and the second state of thetension member 201 is characterized by an angle, β, of theaxis 203 c of thebody 203 of thetension member 201 relative to the horizontal axis, wherein 0≦α<π/2, 0≦β<π/2, and β≠α, as shown inFIGS. 1 a and 1 b. In one embodiment, when thecrank 306 is rotated in adirection 330, it causes theleadscrew 218 of thetension member 201 rotatably to advance into thebody 203 of thetension member 201, which pulls thecable 204 into thebody 203 of thetension member 201 in adirection arrow 250, as shown inFIG. 8 . Therefore, the rotation of thecrank 306 indirectly causes change or here reduction of the length L. Conversely, rotation of thecrank 306 in the opposite direction increases length L.FIG. 9 shows a side view of theactuator 300 and thecylindrical magnet 220 of thetension member 201.FIG. 10 shows a cross-sectional view of thecylindrical magnet 302 of theactuator 300 and thecylindrical magnet 220 of thetension member 201 havingmagnet flux lines 500 and 502, respectively. - Referring to
FIG. 13-16 , adevice 700, which utilizes a toggle mechanism for correction of a spinal deformity, is shown according to an alternative embodiment of the present invention. Thedevice 700 includes acables 704, atension member 701, a first engaging member for mechanically engaging thecable 704 with thetension member 701, and ashackle 202 for mechanically engaging thetension member 701 with a pelvic bone. - In one embodiment, the
tension member 701 has aleadscrew 718 that has ahead 708, ashank 710 extending from thehead 708, and a threadedportion 712 extending from theshank 710. Thetension member 701 further has a one-way clutch 714 coupled with theshank 710. The one-way clutch 714 is configured such that when rotating in one of the clockwise and counterclockwise directions, the one-way clutch 714 engages with theshank 710, and when rotating in the other of the clockwise and counterclockwise directions, the one-way clutch 714 freewheels on theshank 710. Thetension member 701 also has abody 703, which has an interior surface complementarily threaded for receiving theleadscrew 718, afirst end portion 703 a, an opposite,second end portion 703 b, anaxis 703 c, aU-shape cut 703 d and a hole 703 e formed in thesecond end portion 703 b, where the hole 703 e has anaxis 730 perpendicular to theaxis 703 c. Additionally, thetension member 701 has atoggle 702. Thetoggle 702, in one embodiment, has afirst end portion 702 a and an opposite,second end portion 702 b defining achamber 729 therebetween for housing the one-way clutch 714 rigidly, a pair ofwings 705 radially protruding from thesecond end portion 702 b, and a hole 715 formed on thefirst end portion 702 a. - In one embodiment, as shown in
FIG. 14 , the first engaging member has apin 716, and acrimp 706. As assembled,loop portion 738 formed in the first end portion 704 a of thecable 704 engages with thepin 716 and is secured with thecrimp 706. The first engaging member in another embodiment includes a ball-and-socket joint mechanism. - The
device 700 also includes a second engaging member for mechanically engaging thecable 704 with a vertebra (not shown). Preferably, the second engaging member is capable of accommodating changes in the rotational orientation of the cable as curvature is corrected. - The
shackle 202 mechanically engages thetension member 701 with a pelvic bone, according to the procedures as described above. Other engaging means of thetension member 701 with the pelvic bone can also be used to practice the present invention. - In operation, by pressing alternately on each of the pair of
wings 705 of thetoggle 702, the one-way clutch 714 rotates alternately in the clockwise and counterclockwise directions thereby causing theleadscrew 718 to rotatably advance into thebody 703, which in turn pulls thecable 704 into thebody 703 of thetension member 701, whereby the tension of thecable 204 is adjustable for imposing a corrective displacement on thevertebra 100. This operation causes thetension member 201 to move from a first state to a second state that is different from the first state. In one embodiment, the first state and the second state are corresponding to an extended configuration and a collapsed configuration of thetension member 701, as shown inFIGS. 15 and 16 , respectively. - In one aspect, the present invention relates to a device for correction of a spinal deformity. In one embodiment, the device includes a cable having a
first end portion 204 a, and an opposite,second end portion 204 b attachable to avertebra 100, means for adjusting the tension of the cable so as to impose a corrective displacement on thevertebra 100, and means for attaching the body to apelvic bone 102. In one embodiment, the adjusting means comprise a screw having a threaded portion and engaged with the first end portion of the cable, and a body having an interior surface complementarily threaded for receiving the screw such that when the screw rotatably advances into the body, the tension of the cable is adjusted. The adjusting means includes a magnet driving mechanism, a toggle driving mechanism, a hydraulic driving mechanism, or the likes. - In one embodiment, the cable is made of a biocompatible material. The biocompatible material comprises a polymer, a composite, a metal, an alloy, or any combination thereof. In one embodiment, the cable is coated with a material to reduce abrasion and adhesion of biologic tissues.
- In yet a further aspect, the present invention relates to a device for correction of a spinal deformity. In one embodiment, the device includes a tension adjusting member having a first end, a second end, and a body defined therebetween the first end and the second end. The device further includes a tension member having a first end portion, a second end portion and a body portion defined therebetween the first end portion and the second end portion, and movably engaged with the body of the tension adjusting member such that the first end portion of the tension member is movable away from the first end of the tension adjusting member for adjusting the tension of the tension member. In use, the second end portion of the tension member is to be secured to a
vertebra 100 and the first end of the tension adjusting member is to be secured to apelvic bone 102 so that when the first end portion of the tension member is movable away from or toward to the first end of the tension adjusting member, the tension of the tension member is adjusted so as to impose a corrective displacement on thevertebra 100. - A surgical procedure for implantation of the invented device, in one embodiment, includes the following steps: at first, a device having a tension member, a cable engaging with the tension member, and a shackle engaging with the tension member is provided according to one embodiment of the present invention. Then openings at a pelvis bone and a spinal attachment site are incised, respectively. A small hole is drilled through the pelvis bone at a pre-selected position, possibly at or near the iliac crest. The shackle is then secured to the pelvis bone with a screw, clamp or pin. Next, the cable is attached to the spinal attachment site through the openings with an engaging member including bone screws. Once the device is implanted, the wounds are closed and correction of the spinal deformity is performed incrementally and non-invasively according to the procedures as described above.
- The present invention, among other unique features, discloses a non-invasive or minimal invasive device (implant) for correcting abnormal spinal curvatures of a patient. One of advantages of the present invention is the potential to correct the abnormal spinal curvatures without spinal fusion. Permanent correction of the abnormal spinal curvatures is achieved by gradually realigning the spinal column so that force imbalances in the spine no longer exist. In certain cases, the onset of skeletal maturity marks the end of curve progression due to the fact that the supporting structures of the spinal column have reacted to the abnormal spinal curvature and imbalances are eliminated. However, in extreme cases of scoliosis the spinal deformity exceeds a critical point and equilibrium may not be reached and therefore the curve progression continues even after the skeletal maturity. It would appear that correcting the curvature and therefore eliminating the imbalances long enough to allow the viscoelastic properties of the supporting structures of the spinal column to react would result in a permanent curvature correction without the need for fusion. However, if the fusion is required, the implanted device would be removed and the fusion would be performed in a procedure known to the people skilled in the art.
- The foregoing description of the exemplary embodiments of the invention has been presented only for the purposes of illustration and description and is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in light of the above teaching.
- The embodiments were chosen and described in order to explain the principles of the invention and their practical application so as to enable others skilled in the art to utilize the invention and various embodiments and with various modifications as are suited to the particular use contemplated. Alternative embodiments will become apparent to those skilled in the art to which the present invention pertains without departing from its spirit and scope. Accordingly, the scope of the present invention is defined by the appended claims rather than the foregoing description and the exemplary embodiments described therein.
Claims (6)
1. A device for correction of a spinal deformity, comprising:
an implant having a first end portion and an opposite second end portion, said first end portion being attachable to an extraspinal bone, said second end portion being attachable to a vertebra, said implant being configured for being adjusted without penetrating skin and thereby for adjusting a tension of said implant so as to impose a corrective displacement on said vertebra.
2. The device of claim 1 , wherein said implant includes a cable and an adjustment device coupled with said cable, said adjustment device including said first end portion of said implant, said cable including a third end portion and a fourth end portion, said fourth end portion being said second end portion of said implant, said adjustment device being configured for adjusting said tension of said implant so as to impose said corrective displacement on said vertebra, said adjustment device including a screw and a body, said screw having a threaded portion and being engaged with said third end portion of said cable, said body having an interior surface complementarily threaded for receiving said screw such that when said screw rotatably advances into said body said tension of said cable is adjusted.
3. The device of claim 2 , wherein said implant includes a structure configured for attaching said body to a pelvic bone.
4. A device for correction of a spinal deformity, comprising:
a. a tension adjusting member having a first end, a second end, and a body defined therebetween; and
b. a tension member having a first end portion, a second end portion, and a body portion defined therebetween, said tension member being movably engaged with said body of said tension adjusting member such that said first end portion of said tension member is linearly movable relative to said first end of said tension adjusting member for adjusting a tension of said tension member.
5. The device of claim 4 , wherein said second end portion of said tension member is configured for being secured to a vertebra and said first end of said tension adjusting member is configured for being secured to an extraspinal bone so that when said first end portion of said tension member moves one of away from and toward said first end of said tension adjusting member said tension of said tension member is adjusted so that said device is configured for imposing a corrective displacement on said vertebra.
6. A method for correcting a spinal deformity, said method comprising the steps of:
providing an implant including a first end portion and a second end portion opposite said first end portion;
attaching said first end portion to an extraspinal bone;
attaching said second end portion to a vertebra; and
adjusting said implant without penetrating skin and thereby adjusting a tension of said implant.
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US12/779,258 US20100286730A1 (en) | 2004-08-30 | 2010-05-13 | Implant for correction of spinal deformity |
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