WO2014107144A1

WO2014107144A1 - Surgical implant bending system and method

Info

Publication number: WO2014107144A1
Application number: PCT/US2013/000003
Authority: WO
Inventors: Osamu Horie; Noriaki Kawakami
Original assignee: Warsaw Orthopedic, Inc.
Priority date: 2013-01-03
Filing date: 2013-01-03
Publication date: 2014-07-10

Abstract

A surgical instrument comprises a first member including a first portion defining a longitudinal axis, a second transverse portion and a first mating portion. A second member includes a first portion defining a longitudinal axis, a second transverse portion and a second mating portion. A connecting member defines a first axis being disposed transverse to the longitudinal axes and extending between a first end and a second end. The first end engages the first mating portion and the second end engages the second mating portion such that the first member is spaced apart from the second member along the first axis to deform an implant. Systems and methods are disclosed.

Description

SURGICAL IMPLANT BENDING SYSTEM AND METHOD

TECHNICAL FIELD

[0001] The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and a method for treating a spine that includes one or more implants disposed with vertebrae.

BACKGROUND

[0002] Spinal pathologies and disorders such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumor, and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.

[0003] Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs such as vertebral rods are often used to provide stability to a treated region. Rods redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support the vertebral members. Such rods may be attached via fasteners to the exterior of two or more vertebral members. During surgical treatment, one or more rods may require bending for disposal with the vertebral members, for example, during implantation to bend a rod to a shape of the vertebral members. This disclosure describes an improvement over these prior art technologies. SUMMARY

[0004] In one embodiment, in accordance with the principles of the present disclosure, a surgical instrument is provided. The surgical instrument comprises a first member including a first portion defining a longitudinal axis and a second transverse portion being engageable with an implant such that the first member is configured to deform the implant. The first member includes a first mating portion. A second member includes a first portion defining a longitudinal axis and a second transverse portion being engageable with the implant such that the second member is configured to deform the implant. The second member includes a second mating portion. A connecting member defines a first axis being disposed transverse to the longitudinal axes and extending between a first end and a second end. The first end engages the first mating portion and the second end engages the second mating portion such that the first member is spaced apart from the second member along the first axis.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:

[0006] FIG. 1 is a perspective view of components of one particular embodiment of a system in accordance with the principles of the present disclosure;

[0007] FIG. 2 is a perspective view of a component of the system shown in

FIG. 1 ;

[0008] FIG. 3 is a perspective view of components of the system shown in FIG. 1 ; and

[0009] FIG. 4 is a plan view of one embodiment of a system in accordance with the principles of the present disclosure disposed with vertebrae. [0010] Like reference numerals indicate similar parts throughout the figures.

DETAILED DESCRIPTION

[0011] The exemplary embodiments of the surgical system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system and a method for treating a spine that includes one or more implants disposed with vertebrae. In one embodiment, the system includes a surgical instrument having an implant bender that can be used in situ without requiring removal of the implant during a surgical procedure. In one embodiment, the surgical instrument includes a connector having an adjustable length so that an implant, such as, for example, a vertebral rod, can be deformed and/or bent in a plurality of positions. In one embodiment, the surgical instrument is employed in a surgical procedure for treating scoliosis to bend metal spinal rods according to an anatomical curve of a patient's spine.

[0012] In some embodiments, the surgical instrument includes spinal rod benders discussed in terms of medical devices employed during surgical applications. In some embodiments, the surgical instrument includes spinal rod benders configured to bend a vertebral rod in situ. In some embodiments, the rod benders of the present disclosure allow for single-handed operation. In some embodiments, the rod benders of the present disclosure are configured to fit between adjacent bone fasteners to allow for placement in various sections of the spine. In some embodiments, the rod benders of the present disclosure bend a rod coronally between two bone fasteners. In some embodiments, the rod benders are adjustable to allow a medical practitioner to have more control over the plane in which the rod is bent, such as, for example, the coronal plane.

[0013] In one embodiment, the system and method of the present disclosure is employed during spinal surgery for bending spinal rods in applications for degenerative and deformity cases. In one embodiment, the system includes components having a high strength and/or stiffness to bend spinal rods.

[0014] In one embodiment, one or all of the components of the surgical system are disposable, peel-pack, pre-packed sterile devices used with an implant. One or all of the components of the surgical system may be reusable. The surgical system may be configured as a kit with multiple sized and configured components.

[0015] In some embodiments, the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, N osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some embodiments, the disclosed surgical system and methods may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, lateral, postero-lateral, and/or anterolateral approaches, and in other body regions. The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The system and methods of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.

[0016] The present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. Also, as used in the specification and including the appended claims, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and/or to "about" or "approximately" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references "upper" and "lower" are relative and used only in the context to the other, and are not necessarily "superior" and "inferior".

[0017] Further, as used in the specification and including the appended claims, "treating" or "treatment" of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), employing implantable devices, and/or employing instruments that treat the disease, such as, for example, microdiscectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. Also, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.

[0018] The following discussion includes a description of a surgical system and related methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning now to FIGS. 1-3, there is illustrated components of a surgical system, such as, for example, a spinal implant system 10 in accordance with the principles of the present disclosure.

[0019] The components of spinal implant system 10 can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the components of spinal implant system 10, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaS0₄ polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations. Various components of spinal implant system 10 may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of spinal implant system 10, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of spinal implant system 10 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.

[0020] Spinal implant system 10 is employed, for example, with a minimally invasive procedure, including percutaneous techniques, mini-open and open surgical techniques to deliver and introduce an implant, such as, for example, a spinal rod and/or bone fasteners, at a surgical site within a body of a patient, for example, a section of a spine. In one embodiment, spinal implant system 10 includes a surgical instrument, such as, for example, a bending device 12 that is employed, for example, to deform an implant during a surgical treatment to contour the implant to the configuration and/or dimension of the spine. In some embodiments, the contour can include adjustment and/or correction of the components of spinal implant system 10 including, for example, sagittal and coronal alignment.

[0021] Bending device 12 includes a member, such as, for example, a spinal implant bender 14. Bender 14 includes a portion, such as, for example, a handle 16 extending between an end 18 and an end 20. In one embodiment, handle 16 extends a length that allows end 20 to be positioned outside a patient's body, while a distal portion of bender 14 is engaged with an implant within the body of the patient, according to the requirements of a particular application.

[0022] Handle 16 has a substantially linear configuration and defines a longitudinal axis L1. In some embodiments, bender 14 can be variously configured, such as, for example, tubular, arcuate, undulating, staggered, offset, angled, irregular, uniform, non-uniform, variable, hollow and/or tapered. Handle 16 includes a wall 22 having a substantially rectangular cross section and defines a thickness that is substantially uniform. In some embodiments, wall 22 can have alternate cross-section and/or thickness configurations, such as, for example, arcuate, undulating, offset, staggered, tubular, oval, oblong, triangular, square, polygonal, irregular, non-uniform, variable, hollow and/or tapered. In some embodiments, all or only a portion of handle 16 may be disposed at various orientations, relative to axis L1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered.

[0023] Wall 22 has an outer surface 24 having a substantially smooth and/or even configuration. In some embodiments, surface 24 has alternate surface configurations, such as, for example, rough, friction, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured according to the requirements of a particular application. Handle 16 includes a gripping surface 26 extending from wall 22 and adjacent end 20. Gripping surface 26 is configured for manipulation by a practitioner and includes a plurality of openings 28 to enhance gripping. In some embodiments, surface 26 has alternate surface configurations, such as, for example, those alternatives described herein.

[0024] Bender 14 includes a portion, such as, for example, an extension 30 extending distally from handle 16. Extension 30 extends between an end 32 and an end 34. End 32 is connected to end 18 and extends therefrom in an angular orientation. In some embodiments, end 32 may extend from end 18 in various orientations, relative to axis L1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. End 32 is monolithically formed with end 18. In some embodiments, end 32 may be attached and integrally connected to end 18, and/or may be separate and connected via clips, a friction fit, an interference fit, pins and/or an adhesive.

[0025] Extension 30 has a substantially linear configuration and defines an axis A1 disposed in a transverse orientation relative to longitudinal axis L1 . In some embodiments, extension 30 can be variously configured, such as, for example, those alternatives described herein. Extension 30 includes a wall 36 having a substantially rectangular cross section and defining a thickness that is substantially uniform. In some embodiments, wall 36 can have alternate cross-section and/or thickness configurations, such as, arcuate, undulating, offset, staggered, tubular, oval, oblong, triangular, square, polygonal, irregular, non-uniform, variable, hollow and/or tapered. In some embodiments, all or only a portion of extension 30 may be disposed at various orientations, relative to axis A1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In one embodiment, all or only a portion of extension 30 may be cannulated.

[0026] Wall 36 has an outer surface 38 having a substantially smooth and/or even configuration. In some embodiments, surface 38 has alternate surface configurations, such as, for example, those alternatives described herein. End 34 includes an inner surface 40 that defines an implant cavity configured for disposal of an implant, such as, for example, a longitudinal element (FIG. 4). Surface 40 is configured to engage the longitudinal element, such as, for example, a spinal rod within the body of the patient such that bender 14 is configured to deform the spinal rod.

[0027] End 34 includes a pair of spaced apart arms 42 such that inner surface 40 defines a U-shaped passageway 44. Passageway 44 is configured for disposal of an implant, such as a spinal rod. In some embodiments, all or only a portion of passageway 44 may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered. In some embodiments, arms 42 and/or the opening defined by arms 42 to receive the implant, may be disposed at alternate orientations, relative to axis A1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered.

[0028] Bender 14 includes a mating portion, such as, for example, a cylinder 46 laterally connected to end 32 of extension 30. Cylinder 46 is monolithically formed with outer surface 38. In some embodiments, cylinder 46 may extend from extension 30 in various orientations, such as, for example, angular orientations or coaxial. In some embodiments, cylinder 46 may be attached and integrally connected to end 32, and/or may be separate and connected via clips, a friction fit, an interference fit, pins and/or an adhesive.

[0029] Cylinder 46 includes a circumferential wall 48 having an inner surface 50. Inner surface 50 defines a cylindrical cavity 52 that is disposed along an axis A2 oriented transverse to axis L1 and spaced apart in an offset orientation and disposed in substantially parallel relation to axis A1. In some embodiments, cavity 52 may be disposed at alternate orientations, relative to axis L1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered. In some embodiments, all or only a portion of cavity 52 may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered.

[0030] Bending device 12 includes a member, such as, for example, a spinal implant bender 54. Bender 54 includes a portion, such as, for example, a handle 56 extending between an end 58 and an end 60. In one embodiment, handle 56 extends a length that allows end 60 to be positioned outside a patient's body, while a distal portion of bender 54 is engaged with an implant within the body of the patient, according to the requirements of a particular application.

[0031] Handle 56 has a substantially linear configuration and defines a longitudinal axis L2. In some embodiments, bender 54 can be variously configured, such as, for example, tubular, arcuate, undulating, staggered, offset, angled, irregular, uniform, non-uniform, variable, hollow and/or tapered. Handle 56 includes a wall 62 having a substantially rectangular cross section and defines a thickness that is substantially uniform. In some embodiments, wall 62 can have alternate cross-section and/or thickness configurations, such as, for example, arcuate, undulating, offset, staggered, tubular, oval, oblong, triangular, square, polygonal, irregular, non-uniform, variable, hollow and/or tapered. In some embodiments, all or only a portion of handle 56 may be disposed at various orientations, relative to axis L2, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered.

[0032] Wall 62 has an outer surface 64 having a substantially smooth and/or even configuration. In some embodiments, surface 64 has alternate surface configurations, such as, for example, rough, friction, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured according to the requirements of a particular application. Handle 56 includes a gripping surface 66 extending from wall 62 and adjacent end 60. Gripping surface 66 is configured for manipulation by a practitioner and includes a plurality of openings 68 to enhance gripping. In some embodiments, surface 66 has alternate surface configurations, such as, for example, those alternatives described herein.

[0033] Bender 54 includes a portion, such as, for example, an extension 70 extending distally from handle 56. Extension 70 extends between an end 72 and an end 74. End 72 is connected to end 58 and extends therefrom in an angular orientation. In some embodiments, end 72 may extend from end 58 in various orientations, relative to axis L2, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. End 72 is monolithically formed with end 58. In some embodiments, end 72 may be attached and integrally connected to end 58, and/or may be separate and connected via clips, a friction fit, an interference fit, pins and/or an adhesive.

[0034] Extension 70 has a substantially linear configuration and defines an axis A3 disposed in a transverse orientation relative to longitudinal axis L2. In some embodiments, extension 70 can be variously configured, such as, for example, those alternatives described herein. Extension 70 includes a wall 76 having a substantially rectangular cross section and defining a thickness that is substantially uniform. In some embodiments, wall 76 can have alternate cross-section and/or thickness configurations, such as, arcuate, undulating, offset, staggered, tubular, oval, oblong, triangular, square, polygonal, irregular, non-uniform, variable, hollow and/or tapered. In some embodiments, all or only a portion of extension 70 may be disposed at various orientations, relative to axis A3, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In one embodiment, all or only a portion of extension 70 may be cannulated.

[0035] Wall 76 has an outer surface 78 having a substantially smooth and/or even configuration. In some embodiments, surface 78 has alternate surface configurations, such as, for example, those alternatives described herein. End 74 includes an inner surface 80 that defines an implant cavity configured for disposal of an implant, such as, for example, a longitudinal element (FIG. 4). Surface 80 is configured to engage the longitudinal element, such as, for example, a spinal rod within the body of the patient such that bender 54 is configured to deform the spinal rod.

[0036] End 74 includes a pair of spaced apart arms 82 such that inner surface 80 defines a U-shaped passageway 84. Passageway 84 is configured for disposal of an implant, such as a spinal rod. In some embodiments, all or only a portion of passageway 84 may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered. In some embodiments, arms 82 and/or the opening defined by arms 82 to receive the implant, may be disposed at alternate orientations, relative to axis A3, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered.

[0037] Bender 54 includes a mating portion, such as, for example, a cylinder 86 laterally connected to end 72 of extension 70. Cylinder 86 is monolithically formed with outer surface 78. In some embodiments, cylinder 86 may extend from extension 70 in various orientations, such as, for example, angular orientations or coaxial. In some embodiments, cylinder 86 may be attached and integrally connected to end 72, and/or may be separate and connected via clips, a friction fit, an interference fit, pins and/or an adhesive.

[0038] Cylinder 86 includes a circumferential wall 88 having an inner surface 90. Inner surface 90 defines a cylindrical cavity 92 that is disposed along an axis A4 oriented transverse to axis L2 and spaced apart in an offset orientation and disposed in substantially parallel relation to axis A3. In some embodiments, cavity 90 may be disposed at alternate orientations, relative to axis L2, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered. In some embodiments, all or only a portion of cavity 90 may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, and/or tapered.

[0039] Bending device 12 includes a connecting member, such as, for example, a bridge 94 that connects bender 14 with bender 54. Bridge 94 includes a shaft 96 having a cylindrical cross section configuration and including an outer surface 98 having a substantially smooth and/or even configuration. In some embodiments, surface 98 has alternate surface configurations, such as, for example, those alternatives described herein. In some embodiments, all or only a portion of shaft 96 may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered.

[0040] Shaft 96 defines an axis A5 that is disposed transverse to longitudinal axes L1 , L2 and axes A1 , A2, A3, A4. Bridge 94 is configured to selectively space apart bender 14 from bender 54 a dimension d along axis A5. In some embodiments, all or only a portion of shaft 96 may be disposed at alternate orientations, relative to one, a plurality or all of the axes, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered.

[0041] Bridge 94 extends between an end 100 and an end 102. End 100 is configured for engaging cylinder 46 and end 102 is configured for engaging cylinder 86 such that benders 14, 54 are spaced apart along axis A5 for deforming a spinal rod. End 100 includes a transverse shaft 104 having an enlarged diameter portion 106 and a pin 108 configured for disposal with cavity 52. Pin 108 includes a reduced diameter tip 110 configured to guide pin 108 into cavity 52. Pin 108 slides into cavity 52 and an outer surface of pin 108 slidably engages inner surface 50 for removable and/or releasable attachment of pin 108 with cylinder 46. In one embodiment, the outer surface of pin 108 and inner surface 50 are threaded for threaded fixation therebetween and removable and/or releasable attachment of pin 108 with cylinder 46.

[0042] End 102 includes a transverse shaft 112 having an enlarged diameter portion 114 and a pin 116 configured for disposal with cavity 92. Pin 116 includes a reduced diameter tip 118 configured to guide pin 116 into cavity 92. Pin 116 slides into cavity 92 and an outer surface of pin 116 slidably engages inner surface 90 for removable and/or releasable attachment of pin 116 with cylinder 86. The releasable configuration of pins 108, 116 with cylinders 46, 86 provide removable connection of bridge 94 with benders 14, 54. In one embodiment, the outer surface of pin 116 and inner surface 90 are threaded for threaded fixation therebetween and removable and/or releasable attachment of pin 116 with cylinder 86.

[0043] Portion 106 includes a transverse passageway 120 configured for movable disposal of shaft 96. Portion 114 includes a transverse passageway 122 configured for movable disposal of shaft 96. Shaft 96 includes a fixed stop, such as, for example, an enlarged diameter portion 124 that resists disengagement of shaft 96 from end 100. Shaft 96 is axially translatable through passageways 120, 112, in a direction shown by arrow A in FIG. 3, in a range of movement having a stop limit defined by engagement of portion 124 with the surface of portion 106. [0044] Shaft 96 includes a removable stop, such as, for example, a spring biased pin 126. Pin 126 is movable between a first orientation such that pin 126 resists disengagement of shaft 96 from end 102 and a second orientation such that shaft 96 is releasable from end 102. In one embodiment, in the second orientation of pin 126, shaft 96 translates and is releasable from end 100. Pin 126 is biased to the first orientation, as shown in FIG. 3. As such, in the first orientation of pin 126, shaft 96 is axially translatable through passageways 120, 1 12, in a direction shown by arrow B in FIG. 3, in a range of movement having a stop limit defined by engagement of pin 126 with the surface of portion 1 14. In the second orientation of pin 126, pin 126 is recessed into shaft 96 and shaft 96 is axially translatable through passageways 120, 1 12, in a direction shown by arrow B, in a range of movement such that shaft 96 is removable from ends 100, 102.

[0045] Portion 106 includes a threaded inner surface 128 that defines an axial passageway 130 configured for disposal of a locking element, such as, for example, a thumb screw 132. Portion 1 14 includes a threaded inner surface 134 that defines an axial passageway 136 configured for disposal of a locking element, such as, for example, a thumb screw 138. Screws 132, 138 are threaded with passageways 130, 136 for translation relative to portions 106, 114 and into fixed engagement with shaft 96 to selectively space apart benders 14, 54 a fixed distance d, as shown in FIG. 1 , for a locked orientation of bending device 12.

[0046] In one embodiment, distance d is adjustable such that screws 132, 138 are disengaged from shaft 96 and benders 14, 54 are manipulated to adjust distance d according to the requirements of an application. Upon desired adjustment and/or spacing of benders 14, 54, screws 132, 138 are translated into fixation with shaft 96 for a locked orientation of bending device 12. In some embodiments, distance d can be adjusted in a range of: no separation of benders 14, 54 to a distance limit defined by engagement of benders 14, 54 with the surfaces of the bone fasteners supporting a section of a spinal rod disposed therebetween. In some embodiments, distance d can be adjusted within a range of 0 through 50 millimeters (mm). [0047] In one embodiment, spinal implant system 10 comprises a kit, which includes a plurality of shafts 96. Each shaft 96 having a separate and alternate dimension of length along axis A5. In some embodiments, the kit of spinal implant system 10 can include a plurality of shafts 96, each shaft 96 having a length within a range defined by the overall distance up to a distance limit provided by engagement of benders 14, 54 with the surfaces of the bone fasteners supporting a section of a spinal rod disposed therebetween. In some embodiments, the kit of spinal implant system 10 can include a plurality of shafts 96, each shaft 96 having a length within an overall range of 0 through 50 mm.

[0048] Spinal implant system 10 includes an implant, such as, for example, a spinal rod 140, as shown in FIG. 4. Rod 140 extends between an end 142 and an end 144. In some embodiments, all or only a portion of rod 140 may have a semi-rigid, rigid or elastic configuration, and/or have elastic properties, such as the elastic properties corresponding to the material examples described above. In some embodiments, rod 140 can include a plurality of separately attachable or connectable portions or sections, or may be monolithically formed as a single continuous element. In some embodiments, rod 140 is configured to extend over one or a plurality of vertebral levels.

[0049] Rod 140 can have a uniform thickness/diameter. In some embodiments, rod 140 may have various surface configurations, such as, for example, rough, threaded for connection with surgical instruments, arcuate, undulating, porous, semi-porous, dimpled, polished and/or textured according to the requirements of a particular application. In some embodiments, the thickness defined by rod 140 may be uniformly increasing or decreasing, or have alternate diameter dimensions along its length. In some embodiments, rod 140 may have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered.

[0050] In some embodiments, rod 140 may have various lengths, according to the requirements of a particular application. In some embodiments, rod 140 may comprise a tether and be braided, such as a rope, or include a plurality elongated elements to provide a predetermined force resistance.

[0051] Spinal implant system 10 includes implants, such as, for example, a plurality of bone fasteners 146 for attaching spinal rod 140 to vertebrae V, as shown in FIG. 4. In some embodiments, spinal implant system 10 can include one or a plurality of bone fasteners such as those described herein and/or fixation elements, which may be employed with a single vertebral level. In some embodiments, the bone fasteners and/or fixation elements may be engaged with vertebrae in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, the bone fasteners and/or fixation elements may include one or a plurality of anchors, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts.

[0052] In assembly, operation and use, spinal implant system 10, similar to that described herein, is employed with a surgical procedure for treatment of a spinal disorder affecting a section of a spine of a patient, as discussed herein. Spinal implant system 10 may also be employed with other surgical procedures. For example, spinal implant system 10 can be used with a surgical procedure for treatment of a condition or injury, such as, for example, a correction treatment to treat adolescent idiopathic scoliosis and/or Scheuermann's kyphosis of a spine.

[0053] In use, as shown in FIG. 4, to treat the affected section of vertebrae V, a medical practitioner obtains access to a surgical site including vertebrae V in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, spinal implant system 10 may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery, and percutaneous surgical implantation, whereby vertebrae V is accessed through a micro- incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure is performed for treating the spinal disorder. Spinal implant system 10 is then employed to augment the surgical treatment. Pilot holes are made in selected vertebra of vertebrae V for receiving bone fasteners 146. Bone fasteners 146 are fastened with vertebrae V for attachment with rod 140 and connecting rod 140 with vertebrae V.

[0054] In some embodiments, during the surgical procedure, the contour of vertebrae V and/or other portions of an anatomy of a patient selected for disposal and/or attachment of an implant, such as, for example, spinal rod 140 and bone fasteners 146, can be measured and/or determined in situ. In one embodiment, the contour measurement, which may include implant geometry, relative angular orientation of the implant to vertebrae V and/or respective portions of the implant, can be measured and/or determined using medical imaging, gauges, provisional, working and/or trial implants and treated using bending device 12. In one embodiment, implant bending device 12, similar to that described, is used to deform, shape, bend and/or conform rod 140 according to the contour measurements and requirements of a particular application.

[0055] In one embodiment, implant bending device 12, similar to that described, is used to deform, shape, bend and/or conform rod 140 in a deformity correction procedure, which includes in situ coronal bending for residual coronal or sagittal deformity. For example, benders 14, 54 are assembled with bridge 94, as described herein. Ends 34, 74 are oriented such that a portion 150 of rod 140 is disposed with passageway 44 and a portion 152 of rod 140 is disposed with passageway 84. Benders 14, 54 are spaced apart such that ends 32, 72 are spaced apart a selected distance d. Screws 132, 138 are threaded with passageways 130, 136 for translation relative to portions 106, 1 14 and into fixed engagement with shaft 96 to selectively space apart benders 14, 54 fixed distance d for a locked orientation of bending device 12.

[0056] Extensions 30, 70 engage rod 140 in a substantially sagittal plane of vertebrae V and handles 16, 56 define a working plane. The working plane is spaced apart and disposed in substantially parallel relation to a substantially coronal plane of vertebrae V such that benders 14, 54 are configured to deform rod 140 in the substantially coronal plane. Benders 14, 54 are manipulated, in the direction shown by arrows C in FIG. 4, to provide adjustments to vertebrae V in the coronal plane. In some embodiments, derotation, correction and sagittal adjustments can be performed.

[0057] In some embodiments, spinal implant system 10 includes an agent, which may be disposed, packed or layered within, on or about the components and/or surfaces of spinal implant system 10. In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of bone fasteners 146 with vertebrae V. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration.

[0058] The components of spinal implant system 10 can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, the use of microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of spinal implant system 10. Upon completion of the procedure, the surgical instruments, assemblies and non-implant components of spinal implant system 10 are removed from the surgical site and the incision is closed.

[0059] In some embodiments, the components of spinal implant system 10 may be employed to treat progressive idiopathic scoliosis with or without sagittal deformity in either infantile or juvenile patients, including but not limited to prepubescent children, adolescents from 10-12 years old with continued growth potential, and/or older children whose growth spurt is late or who otherwise retain growth potential. In some embodiments, the components of spinal implant system 10 and methods of use may be used to prevent or minimize curve progression in individuals of various ages.

[0060] It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

WHAT IS CLAIMED IS:

1. A surgical instrument comprising: a first member including a first portion defining a longitudinal axis and a second transverse portion being engageable with an implant such that the first member is configured to deform the implant, the first member further including a first mating portion; a second member including a first portion defining a longitudinal axis and a second transverse portion being engageable with the implant such that the second member is configured to deform the implant, the second member further including a second mating portion; and a connecting member defining a first axis being disposed transverse to the longitudinal axes and extending between a first end and a second end, the first end engaging the first mating portion and the second end engaging the second mating portion such that the first member is spaced apart from the second member along the first axis.

2. A surgical instrument as recited in claim 1 , wherein at least one of the mating portions comprise a wall that defines a cavity configured for disposal of a respective end, the cavity being disposed along an axis oriented transverse to a respective longitudinal axis.

3. A surgical instrument as recited in claim 1 , wherein the mating portions each comprise a cylinder that defines a cavity configured for disposal of a respective end that comprises a shaft, the cavity being disposed along an axis oriented transverse to a respective longitudinal axis.

4. A surgical instrument as recited in claim 1 , wherein the mating portions each include threaded inner surfaces defining a cavity, the ends being configured for threaded fixation with the inner surfaces such that the connecting member is removably engaged with the first member and the second member.

5. A surgical instrument as recited in claim 1 , wherein the ends each include a transverse pin configured for engagement with a respective mating portion, the pin having a reduced diameter tip configured to guide the pin into attachment with the mating portion.

6. A surgical instrument as recited in claim 1 , wherein the connecting member is configured to selectively space apart the first member and the second member a dimension of length along the first axis.

7. A surgical instrument as recited in claim 1 , wherein the connecting element includes a shaft having at least one stop configured to resist disengagement from the ends.

8. A surgical instrument as recited in claim 1 , wherein the connecting member includes a fixed stop that resists disengagement of the connecting member from the first end and a removable stop that is movable between a first orientation such that the removable stop resists disengagement of the connecting member from the second end and a second orientation such that the connecting member is releasable from the second end.

9. A surgical instrument as recited in claim 1 , wherein the connecting member includes at least one locking element for selectively spacing apart the members a fixed distance.

10. A surgical instrument as recited in claim 9, wherein the at least one locking element includes a thumb screw.

11. A surgical instrument as recited in claim 1 , wherein the connecting member is removably connected to the members.

12. A surgical instrument as recited in claim 1 , wherein the second portion of the first member includes a surface defining an implant cavity configured for disposal of a first portion of the implant and the second portion of the second member includes a surface defining an implant cavity configured for disposal of a second portion of the implant, the members being configured to deform the implant in a substantially coronal plane of a body.

13. A surgical instrument as recited in claim 1 , wherein the second portions are configured to engage the implant in a substantially sagittal plane of a body and the first portions define a working plane, the working plane being spaced apart and disposed in substantially parallel relation to a substantially coronal plane of the body.

14. A surgical instrument comprising: a first spinal implant bender including a handle defining a longitudinal axis and an extension defining a transverse axis, the extension being engageable with a spinal implant such that the bender is configured to deform the spinal implant, the bender further including a cylinder that defines a cavity disposed along an axis oriented transverse to the longitudinal axis; a second spinal implant bender including a handle defining a longitudinal axis and an extension defining a transverse axis, the extension of the second bender being engageable with the spinal implant such that the second bender is configured to deform the spinal implant, the second bender further including a cylinder that defines a cavity disposed along an axis oriented transverse to the longitudinal axis of the handle of the second bender; and a bridge defining a first axis being disposed transverse to the longitudinal axes and extending between a first end including a transverse shaft and a second end including a transverse shaft, the shafts being disposable with the cavities and configured for mating engagement with the cylinders such that the first member is spaced apart from the second member along the first axis.

15. A surgical instrument as recited in claim 14, wherein the bridge is removably connected to the benders.

16. A surgical instrument as recited in claim 14, wherein the bridge includes at least one locking element for selectively spacing apart the benders a fixed distance.

17. A surgical instrument as recited in claim 14, wherein the bridge is configured to selectively space apart the first bender and the second bender a dimension of length along the first axis.

18. A surgical instrument as recited in claim 14, wherein the extensions are configured to engage the spinal implant in a substantially sagittal plane of a body and the handles define a working plane, the working plane being spaced apart and disposed in substantially parallel relation to a substantially coronal plane of the body.

19. A spinal implant system comprising: a surgical instrument comprising: a first member including a first portion defining a longitudinal axis, a second transverse portion and a first mating portion, a second member including a first portion defining a longitudinal axis, a second transverse portion and a second mating portion, and at least one connecting member defining a first axis being disposed transverse to the longitudinal axes and extending between a first end and a second end, the first end engaging the first mating portion and the second end engaging the second mating portion such that the first member is spaced apart from the second member along the first axis; and a spinal rod, wherein the second transverse portions are engageable the spinal rod in a substantially sagittal plane of a body and the first portions define a working plane, the working plane being spaced apart and disposed in substantially parallel relation to a substantially coronal plane of the body such that the members are configured to deform the spinal rod in the substantially coronal plane.

20. A spinal implant system as recited in claim 19, wherein the at least one connecting member includes a plurality of connecting members, each connecting member having an alternate dimension of length along the axis.