法国专利FR3014677A1 SYSTEM AND METHOD FOR SPINAL CORRECTION

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专利摘要:
A spinal structure (12) includes a spinal rod (14) and a reduction member (16) connected to the spinal rod (14) and engageable with a clip (50) connected to the spinal rod (14). The reduction member (16) is translatable relative to the clip (50) to arrange the spinal rod (14) with a fastener (40) configured to penetrate the tissue. Systems and methods are described.
公开号:FR3014677A1
申请号:FR1462189
申请日:2014-12-10
公开日:2015-06-19
发明作者:Joshua Simpson；Dennis Crandall；Jason May
申请人:Warsaw Orthopedic Inc；
IPC主号:

专利说明:

[0001] TECHNICAL FIELD The present description generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system for correcting a disorder of the spine. Background Vertebral disorders such as disc degeneration, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other deviation abnormalities, kyphosis, tumor and fracture may arise from other factors including trauma, disease and degenerative conditions caused by injury and aging. Vertebral disorders typically result in symptoms including pain, nerve damage, and partial or total loss of mobility. Non-surgical treatments, such as medical treatment, rehabilitation, and exercise may be effective, but may not be successful in reducing the symptoms associated with these disorders. Surgical treatment of these vertebral disorders including discectomy, laminectomy, fusion and implantable prostheses. The correction treatments used for the positioning and alignment of the vertebrae may use implants such as for example spinal structures. Spinal structures, which may include rods and bone screws, are manipulated with surgical instruments for engagement with the vertebrae to position and align one or more vertebrae. This description describes an improvement over these technologies of the prior art.
[0002] In one embodiment, a spinal structure is provided. The spinal structure includes a spinal rod and a reduction member connected to the spinal rod and engageable with a clip connected to the spinal rod. The reduction member is translatable relative to the clip to arrange the spinal rod with a fastener configured to penetrate the tissue. In some embodiments, systems and methods are provided.
[0003] Thus, the invention relates to a spinal structure comprising: a spinal rod; and a reduction element connected with the spinal rod and engageable with a fastener connected to the spinal rod, the reduction element being able to translate with respect to the fastener in order to arrange the spinal rod with a fastener configured to penetrate the fabric. According to one embodiment, the reduction element comprises a detent that can engage with the fastener. According to one embodiment, the reduction element comprises a crimp that resists the movement of the reduction element in at least one direction. In one embodiment, the crimp includes an inner surface having at least one penetrating member engageable with the fastener to resist movement in the at least one direction.
[0004] According to one embodiment, the reduction element can perform a translation movement in a first axial direction and there is a resistance to the translation of the reduction element in a second axial direction. According to one embodiment, the reduction element comprises a connector defining a cavity configured to arrange the spinal rod and couple the spinal rod with the clip. According to one embodiment, the fastener comprises a band.
[0005] In one embodiment, the spinal rod includes a first end attached to a bone screw secured with vertebrae and a second end connected to the attachment. According to one embodiment, the attachment comprises a head and a rod for penetrating the tissue, the head being rotatable relative to the rod. In one embodiment, the head includes a pivot that rotates about a shaft axis and an anchor connected to the fastener that rotates the fastener about an anchor axis relative to the pivot. According to one embodiment, the head rotates the fastener in a plurality of axial orientations relative to the rod. According to one embodiment, the fastener comprises a loop wrapped around the spinal rod. The invention also relates to a spinal implant system comprising: - a fastener; - an implant; and - a reduction member connected to the implant and engageable with the fastener so that the reduction member is movable in a first direction relative to the fastener to effect translational movement to the fastener; implant to a position adjacent a fixation configured to penetrate the tissue and is blocked in its movement in a second direction. In particular, the implant may be the spinal structure above.
[0006] According to one embodiment, the reduction element comprises a tensioning device engageable with the fastener. According to one embodiment, the tensioning device comprises a snap which pulls the fastener through the tensioning device. According to one embodiment, the attachment comprises a head and a rod for penetrating the tissue, the head being rotatable relative to the rod. In one embodiment, the head includes a pivot that rotates about a shaft axis and an anchor connected to the fastener that rotates the fastener about an anchor axis relative to the pivot.
[0007] According to one embodiment, the head rotates the fastener in a plurality of axial orientations relative to the rod. The invention also relates to a method for treating a spine, the method comprising the steps of: providing a fastener connectable to a fastener; - connect the fixation with the spinal tissue in a configuration to penetrate the spinal tissue; providing a spinal rod engageable with the fastener; and - causing the spinal rod to translate along the attachment to reduce the spinal rod with the attachment. According to one embodiment, the method further comprises the step of providing a reduction member engageable with the clip and connected with the spinal rod so that the reduction member is movable in a first direction by relative to the clip to translate the spinal rod to a position adjacent to the attachment and is prevented from moving in a second direction. BRIEF DESCRIPTION OF THE DRAWINGS The present description will become more apparent from the specific description accompanied by the following drawings, in which: FIG. 1 is a side view of the components of an embodiment of a system according to the principles of the present invention; description; Fig. 2 is a side sectional view of the components of the system shown in Fig. 1; Fig. 3 is a side sectional view of the components of the system shown in Fig. 1; Figure 4 is a sectional view of the components of the system shown in Figure 1; Figure 5 is a sectional view of the components of the system shown in Figure 1; Figure 6 is a plan view of the components of an embodiment of a system according to the principles of the present description, arranged with the vertebrae; Figure 7 is a side perspective view, partly in section, of the components of an embodiment of a system according to the principles of the present description; Fig. 8 is a detailed view of the components of the system shown in Fig. 7; Fig. 9 is a detailed view of the components of the system shown in Fig. 7; Fig. 10 is a detailed view of the components of an embodiment of a system according to the principles of the present description; and Fig. 11 is a side perspective view, partly in section, of the components of the system shown in Fig. 7.
[0008] DETAILED DESCRIPTION The exemplary embodiments of the disclosed system and related methods of use are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of surgical system and method for the correction of musculoskeletal disorders. a vertebral disorder. In one embodiment, there is provided a surgical system comprising a reduction mechanism having a long range. In one embodiment, the reduction mechanism has variability in one direction of the range. In one embodiment, the surgical system includes a spinal tissue-coupled fastener via a bone fixation, such as, for example, a bone screw and a shaft such as, for example, a spinal rod. The spinal rod can be reduced to the spinal tissue by pulling the spinal rod down from the attachment. In one embodiment, a unidirectional crimp may be used to prevent the spinal rod from emerging from the bone screw. In one embodiment, the surgical system is used for a large reduction or reduction of hypercyphosis or reduction of spondylolisthesis. In one embodiment, the surgical system may be used for a translational correction technique. In one embodiment, the crimp is lockable with the bone screw for final tightening and can be a permanent implantable component of the surgical system. In one embodiment, the fastener is used in a reduction of spondylolisthesis to pull the vertebrae to the spinal rod. In one embodiment, there is provided a surgical system comprising a fixation of bone, such as for example a pedicle screw, a rod attachment, such as for example connectors, a tensioning device and a longitudinal element such as for example a spinal rod. In one embodiment, the pedicle screw comprises a head having two loops for fastening two fasteners, such as for example a broad band of synthetic polyester fibers of 4 millimeters (mm). In one embodiment, the pedicle screw is connected to a clip. In one embodiment, the pedicle screw includes a head having an anchor connected to the clip and pivotable relative to the pedicle screw. In one embodiment, the connector is engaged with the spinal rod and the clip to couple the spinal rod with the clip. In one embodiment, the connector locks the band on the rod. In one embodiment, the connector is an open connector. In one embodiment, the connector locks the 4 mm band on the spinal rod. In one embodiment, the tensioning device pulls the spinal rod along the band toward the pedicle screw. In one embodiment, the voltage device comprises a dispensing gun type configuration. In some embodiments, one or all of the components of the spinal correction system may be sterile disposable, peel-wrapped, pre-packaged devices. One or all of the system components may be reusable. The system can be configured as a kit with configured components and multiple size. In some embodiments, the present disclosure may be used to treat vertebral disorders such as, for example, disc degeneration, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other deviation abnormalities, kyphosis. , a tumor and fractures. In some embodiments, the present disclosure may be used with other osteotic and bone-related applications, including those associated with diagnostics and therapies. In some embodiments, the described system may alternatively be used for surgical treatment with a patient in a prone or back position, and / or use different surgical approaches to the spine including the anterior approaches, posterior, posterior medial, lateral lateral, posterolateral and / or anterolateral, and in other body regions. The present disclosure may also be used alternatively with procedures for treating the lumbar, cervical, thoracic and pelvic regions of a spinal column. The system and methods of the present disclosure can also be used on animals, bone models and other artificial substrates, such as for training, testing and demonstration purposes. The present description will become more apparent with reference to the following detailed description of the description taken in conjunction with the accompanying drawings which form part of this specification. It is to be understood that the present description is not limited to the specific devices, methods, conditions or parameters described and / or represented herein, and that the terminology used herein is intended to describe particular embodiments by way of example only. and is not understood to limit the description claimed. Also, as used in the appended claims, in some embodiments, the singular form "a" (a) and "the" (1a) include the plural and the reference to a particular numerical value includes at least that particular value unless the context clearly indicates otherwise. Ranges can be expressed here as "about" or "approximately" a particular value and / or up to "about" or "approximately" another particular value. When such a range is expressed, another embodiment comprises from the first particular value and / or up to the other particular value. Similarly, when the values are printed as approximations, using the "about" antecedent, it is to be understood that the particular value forms another embodiment. It should also be understood that all spatial references, such as, for example, horizontal, vertical, up, up, down, bottom, left and right are for illustrative purposes only and may be modified as part of the description. For example, the references "upper" and "lower" are relative and used only in context with respect to each other and are not necessarily "superior" and "lower". Furthermore, as used in the description and including the appended claims, the terms "treat" or "treat" a disease or condition refer to performing a procedure which may include administering one or more multiple medications to a patient (human, normal or other, or other mammal), to relieve signs or symptoms of the disease or condition. Relief can occur before the signs or symptoms of the disease or condition appear, as well as after their onset. Thus, the terms "treat" or "treatment" include preventing or preventing the disease or undesirable condition (e.g., preventing the disease from appearing on a patient who may be susceptible to the disease but who has not yet been diagnosed as affected). In addition, treating or treatment does not require complete relief of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. The treatment may include inhibiting the disease, for example, by stopping its development or reducing the disease for example by causing the regression of the disease. For example, the treatment may include the reduction of acute or chronic inflammation; the relief of pain and the attenuation and induction of growth of a new ligament, bone or other tissues; as an adjunct to surgery; and / or in any restorative procedure. Also, as used in the specification and including the appended claims, the term "tissue" includes soft tissue, vessels, ligaments, tendons, cartilage and / or bone, unless otherwise indicated. The following discussion includes a description of a system according to the principles of the present description. Alternative embodiments are also described. Reference is made in detail to the embodiments of the present description given as examples, which are illustrated in the accompanying figures. With reference to FIGS. 1 to 6, components of a system, such as for example a spinal correction system 10 according to the principles of the present description, are illustrated.
[0009] The components of the system 10 may be made from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, bone material, tissue and / or their composites, depending on the particular application and / or the preference of a doctor. For example, system components 10, individually or collectively, can be made from materials such as stainless steel alloys, aluminum, pure commercial titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, stainless steel alloys, superelastic metal alloys (eg Nitinol, superelastic-plastics metals, such as GUM METAL® manufactured by Toyota Material Incorporated) in Japan), ceramics and their composites such as calcium phosphate (for example SKELITETM manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone ( PEK), carbon composites - PEEK, PEEK-BaSO4 polymer rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane opolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material comprising autograft, allograft, xenograft or transgenic cortical and / or cortico-cancellous bone, and tissue growth or differentiation factors , partially absorbable materials, such as, for example, metal composites and calcium-based ceramics, PEEK composites and calcium-based ceramics, PEEK composites with resorbable polymers, fully resorbable materials such as by example calcium-based ceramics such as calcium phosphate alkali, tricalcium diphosphate (TCP), hydroxyapatite (HA) -TCP, calcium sulfate, or other resorbable polymers such as polyacetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and combinations thereof. Different components of the system 10 may have material composites, including the above materials, to achieve various desired characteristics such as strength, stiffness, elasticity, flexibility, biomechanical performance, durability and radiolucency or the imaging preference. System components 10, individually or collectively, may also be made from a heterogeneous material, such as a combination of two or more of the materials described above. The components of the system 10 may be monolithically formed, integrally connected, or comprise elements and / or fasteners, as described herein. The system 10 comprises a spinal structure 12 comprising an implant, such as for example a spinal rod 14 and a reduction element 16 connected to the spinal rod 14. The reduction element 16 reduces the spinal rod 14 along a fastener 50 in a head 42 of a fixation, such as for example a bone screw 40 together with the treatment of a spinal deformity. The spinal rod 14 comprises an end 18 and an end 20 defining a longitudinal axis A1 between them. The end 18 is configured to be attached to a fastener, such as for example a bone screw 30 secured with vertebrae and the end 20 is configured for connection with the bone screw 40 secured with vertebrae so that the movement of the vertebrae is countered and / or prevented between them. The spinal rod 14 has a curved sectional configuration and is substantially cylindrical. In some embodiments, the spinal rod 14 has a configuration of differently shaped sections, such as, for example, round, oval, oblong, square, triangular, rectangular, irregular, uniform, nonuniform, constant and / or variable. In one embodiment, the spinal rod 14 is arranged to extend along an axial plane, such as for example a sagittal plane of the body of a patient. In some embodiments, the system 10 may include one or a plurality of spinal rods 14. In some embodiments, one or a plurality of spinal rods 14 may be arranged in different relative orientations, such as, for example, side by side, parallel, transverse, perpendicular or angular and / or arranged to extend along the coronal, sagittal and transverse planes of a body. The system 10 includes the clip 50. In some embodiments, the clip 50 comprises a band. The clip 50 extends between one end 54 and one end 56 connected with the head 42 of the bone screw 40. In one embodiment, the clip 50 comprises a loop surrounded around the spinal rod 14. In some embodiments embodiments, the clip 50 has a flexible configuration, which includes movement in a lateral or side-by-side direction and prevents expansion and / or extension in an axial direction following fixation with the vertebrae, as described right here. In some embodiments, all or a single fastener portion 50 may have a semi-rigid, rigid, flexible or elastic configuration and / or have elastic and / or flexible properties such as elastic and / or flexible properties corresponding to the examples of material described above so that the clip 50 provides a selective amount of expansion and / or extension in an axial direction. In some embodiments, the clip 50 may be compressible in an axial direction. The clip 50 may include a plurality of separately connectable portions or sections, such as strips or loops, or may be formed monolithically as a single continuous member. The fastener 50 has an outer surface 52 and a uniform thickness / diameter. In some embodiments, the outer surface 52 may have different surface configurations, such as, for example, rough, threaded for connection with surgical instruments, curved, corrugated, porous, semi-porous, wrinkled, polished and / or textured. In some embodiments, the thickness defined by the clip 50 may increase or decrease uniformly, or have alternative diameter dimensions along its length. In some embodiments, the fastener 50 may have different sectional configurations, such as oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, nonuniform, variable and / or tapered. In some embodiments, the fastener 50 may have different lengths. In some embodiments, the fastener 50 may be braided, such as a rope, or comprise a plurality of elongate members to provide a predetermined strength of strength. In some embodiments, the clip 50 may be made from an autograft and / or allograft, as described herein, and configured for resorbable or degradable applications.
[0010] In some embodiments, the fastener 50 may include one or a plurality of flexible threads, staples, cables, tapes, artificial and / or synthetic strands, stems, plates, springs, and combinations thereof. In one embodiment, the clip 50 is a cadaver tendon. In one embodiment, the fastener 50 is a solid core. In one embodiment, the clip 50 is tubular. The system 10 includes a bone screw 30 secured with the end 18 of the spinal rod 14 and connected with the spinal tissue, such as, for example, the vertebrae. The bone screw 30 comprises a first part, such as for example a head 32 and a second part such as for example an elongate rod 34 configured to penetrate into the tissue. The head 32 defines an internal surface defining a cavity, such as for example a U-shaped implant cavity, configured to arrange the end 18 of the spinal rod 14. The rod 34 has a cylindrical cross-sectional configuration and comprises an outer surface having an external threaded form. In some embodiments, the thread shape may comprise a single thread turn or a plurality of separate threads. In some embodiments, other engagement structures may be positioned on the shank 34, such as, for example, a nail pattern, tips, expansion members, raised elements, and / or spikes to facilitate placement. in engagement with the rod 34 with the tissue, for example, vertebrae. In some embodiments, all or only part of the rod 34 may have alternative sectional configurations, such as oval, oblong, triangular, square, polygonal, irregular, uniform, nonuniform, staggered, staggered, wavy, curved, variable and / or tapered. In some embodiments, the outer surface of the rod 34 may include one or a plurality of openings. In some embodiments, all or only a portion of the outer surface of the shank 34 may have alternate surface configurations to enhance attachment to the fabric, such as, for example, rough, curved, wavy, mesh porous, semi-porous, wrinkled and / or textured. In certain embodiments, all or only part of the rod 34 may be arranged in alternative orientations, with respect to the axis A1, such as, for example, transverse, perpendicular and / or angular orientations such as acute or obtuse, coaxial and / or may be staggered or staggered. In some embodiments, all or only a portion of the rod 34 may be fluted. The system 10 includes a bone screw 40, similar to the bone screw 30 described herein. The bone screw 40 is configured to engage spinal tissue spaced apart from the bone screw 30. The bone screw 40 is connected to the end 56 of the clip 50 and can be connected with the bone screw 40. 20 end of the spinal rod 14 following the reduction of the spinal rod 14 along the fastener 50 and in engagement with the bone screw 40. The bone screw 40 comprises a first portion, such as for example a head 42 and a second portion such as, for example, a rod 44 configured for penetrating engagement with the tissue, such as, for example, spinal tissue. The head 42 includes a pair of arms defining a U-shaped implant cavity 43 configured to arrange the spinal rod 14. The end 56 of the clip 50 may be monolithically shaped with, connected, or secured integrally. with attachment members to the head 42 of the bone screw 40. The bone screw 40 includes an engaging portion 46 disposed at a distal end of the head 42. In some embodiments, the portion The engaging member 46 is arranged with different head portions 42 of the bone screw 40, such as, for example, spaced arms within the U-shaped implant cavity 43 or the stem 44. 46 is a semicircular configuration and is configured to rotate the clip 50 about the latter so that the spinal rod 14 can translate along the clip 50 into the socket. implant 43. In some embodiments the engaging portion 46 is configured differently, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, U-shaped, horseshoe-shaped, bean shaped, variable and / or conical. In some embodiments, the clip 50 is connected to the head 42 by various fastening mechanisms, such as, for example, knobs, clips, snaps, friction fittings, compression fittings, expandable rivets, staples, nails and / or adhesives. In some embodiments, one or a plurality of bone screws may be connected with the clip 50. In some embodiments, the system 10 may include one or a plurality of bone screws, such as those described herein and / or fixation elements, which can be used with a single vertebral level or a plurality of vertebral levels. In some embodiments, the bone screws may be engaged with vertebrae in different orientations such as, for example, serially, parallel, staggered, staggered, and / or alternate vertebral levels. In some embodiments, the bone screws and / or the fixation members may comprise one or a plurality of multiaxial screws, sagittal screws, pedicle screws, monoaxial screws, flat screws, fixed screws, tissue screw, conventional screws, expansion screws, wedges, anchors, knobs, pliers, pressure, friction fittings, compression fittings, expandable rivets, staples, nails, adhesives, uprights, plates and / or mounting posts. These bone screws and / or fixation members may be covered with osteoinductive or osteoconductive material to enhance fixation and / or include one or a plurality of therapeutic agents. The reduction member 16 is connected with the spinal rod 14 and is engageable with the clip 50 to connect the clip 50 with the spinal rod 14. The reduction member 16 has a rectangular configuration. In some embodiments, the reduction member 16 is configured differently, such as cylindrical, oval, oblong, conical, uniform, non-uniform, curved, round, triangular, square, bean-shaped, polygonal, irregular, constant and / or variable. The reduction member 16 includes an inner surface 66 defining a cavity 68 that extends through its thickness configured to arrange the clip 50. The reduction member 16 can translate with respect to and along the the fastener 50 for arranging the spinal rod 14 with the implant cavity 43 of the bone screw 40. The reduction element 16 is movable, as for example able to perform a translation movement, in a first direction, as shown by the arrow C in FIG. 1. The translation of the reduction element 16 is counteracted and / or prevented in a second direction, as represented by the arrow D in FIG. 1. The reduction element 16 is movable in the first direction relative to the clip 50 to translate the spinal rod 14 to a position adjacent to the bone screw 40. In some embodiments, the direction of movement is acement of the element 16 relative to the fastener 50 may include linear translation, curved, staggered and / or staggered. In some embodiments, the translation of the reduction element 16 is counteracted and / or is selectively prevented in the second direction. The reduction element 16 comprises a connector 90, as shown in FIG. 3, connected to the spinal rod 14. The connector 90 couples the spinal rod 14 with the clip 50 so that the spinal rod 14 moves with the spinal rod 14. reduction member 16. The connector 90 comprises a curved arm 92 and a curved arm 94 together defining a cavity 96 configured to arrange the spinal rod 14. In some embodiments, the arms 92, 94 are relatively movable to expand and / or The connector 90 comprises a coupling element, such as for example a screw 98. The screw 98 is threadedly engaged with at least one of the arms 92, 94. With the spinal rod 14 arranged in the cavity 96, the screw 98 performs an axial translation movement in engagement with the spinal rod 14 so that the spinal rod 14 is captured in the cavity 96 between the arms 92, 94. In some embodiments, the connector 90 is connected integrally to or formed monolithically with the reduction member 16. In one embodiment, the end 20 of the spinal rod 14 includes a hole (not shown) extending through its thickness configured to arrange the spine. clip 50 so that the clip 50 can translate through the hole. In one embodiment, as shown in FIG. 4, the reduction element 16 comprises a crimp 70 which resists the movement of the reduction element 16 in at least one direction, as for example, in the direction represented by FIG. D. The crimp 70 includes an inner surface 66 which has at least one penetrating member, such as teeth 72, engageable with the clip 50 to resist movement in the at least one direction. The teeth 72 extend from the inner surface 66 into the cavity 68 in an angular orientation so that the teeth 72 penetrate the clip 50 as the crimp 70 moves in the second direction. In some embodiments, the teeth 72 may be arranged in alternative orientations, with respect to the inner surface 66 of the crimp 70, such as for example transverse, and / or other angular orientations such as acute or obtuse, coaxial and / or or may be staggered or staggered. In some embodiments, crimp 70 may include one or a plurality of penetrating members. In some embodiments, the teeth 72 may be configured in various ways, such as with nails, sawtooth, textured, staggered, irregular, corrugated, smooth, with tips and / or raised elements to facilitate coupling with the clip 50 during movement of the crimp 70 in the second direction.
[0011] In one embodiment, as shown in Fig. 5, the reduction member 16 includes a detent 80 engageable with the fastener 50. The detent 80 includes a series of linearly extending linear racks 82. from the inner surface 66 in the cavity 68 in an angular orientation so that the racks 82 engage the outer surface 52 of the clip 50 as the latch 80 moves in the second direction. The racks 82 have a tapered configuration from the inner surface 66 to the recess 68. In some embodiments, the racks 82 are differently configured, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular uniform, non-uniform, variable and / or tapered. In some embodiments, the clip 50 includes an engagement feature, such as a pawl (not shown) configured to engage the racks 82 during the movement of the ratchet 80 in the second direction. In operation, the bone screw 40 is connected with the end 56 of the clip 50. The bone screw 40 is connected with the spinal tissue, such as, for example, a selected first vertebral level, in a configuration to penetrate in the first vertebral level. The bone screw 30 is connected with the spinal tissue, such as, for example, a second vertebral level, remote from the first vertebral level. The end 18 of the spinal rod 14 is fixed with the bone screw 30 fixed with the second vertebral level and the end 20 of the spinal rod 14 is captured in the cavity 96 of the connector 90. The clip 50 is arranged in the cavity 68 of the reduction element 16 so that the spinal rod 14 is connected with the fastener 50. The tension is applied to the fastener 50 and the reduction element 16 translational movement relative to the 50, in the direction shown by the arrow C in Figure 1, causing a translational movement at the end 20 of the spinal rod 14 along the clip 50 to reduce the spinal rod 14 with the cavity U-shaped implant 43 of the bone screw 40 and / or an adjacent bone screw. In some embodiments, the translation of the spinal rod 14 along the clip 50 applies a correction force to the vertebrae to selectively align the vertebrae. In some embodiments, the clip 50 is detached from the bone screw 40 following the arrangement of the end 20 of the spinal rod 14 with the bone screw 40. During assembly, operation and In use, a surgical system comprising the spinal correction system 10, similar to the systems and methods described herein, is used with a surgical correction procedure. For example, the spinal correction system 10 may be used for surgical procedures to treat disorders of the spine, such as abnormal deviations of a spine including hypercyphosis. In some embodiments, one or all of the components of the spinal implant system 10 may be implanted or implanted as a pre-assembled device or may be assembled in situ. The components of the spinal correction system 10 may be completely or partially revised, removed or replaced. For example, the spinal correction system 10 may be used with a surgical correction treatment of an applicable condition or injury of an affected section of a spine and adjacent areas within a body, such as by For example, in order to treat a selected section of the vertebrae V, a physician obtains access to a surgical site comprising the vertebrae V in any appropriate manner, for example incising and retracting the tissues. In some embodiments, the spinal correction system 10 may be used with any surgical method or surgical technique including open surgery, mini open surgery, minimally invasive surgery, and percutaneous surgical implantation. whereby the vertebrae V are accessible by a mini incision or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure can be performed to treat the vertebral disorder. One or a plurality of incisions are made in the body of a patient and the cutting instrument (not shown) creates one or a plurality of surgical pathways and / or openings for implantation of the system components. spinal correction 10. A preparation instrument (not shown) may be used to prepare vertebral tissue surfaces V, as well as aspiration and irrigation of a surgical area.
[0012] Pilot holes (not shown) are made bilaterally in selected levels of the vertebrae V, for example, the vertebrae V1, V2 for receiving the bone screws 30, 40. The rods 34, 44 are inserted, drilled or fixed. in another manner on the vertebrae V1, V2 to attach the bone screws 30, 40 to the vertebrae V. Each of the bone screws 40 is connected with a separate fastener 50. The spinal rod 14 and a spinal rod 13, similar to the spinal rod 14 described here, are placed along the surgical passageway to the surgical site adjacent to the vertebrae V. In some embodiments, the spinal rods 13, 14 and the spinal structure 12 and / or the bone screws 30, 40 can be laid or implanted as pre-assembled components or can be assembled in situ. The spinal rods 13, 14 are positioned to be arranged within the U-shaped implant cavities of the bone screws 30 to connect the spinal rods 13, 14 with the bone screws 30. In some embodiments the spinal rods 13, 14 may be attached to the vertebrae V with a plurality of bone attachments on a plurality of vertebral levels. The spinal rods 13, 14 are arranged with the vertebrae in a side-by-side orientation. In some embodiments, the spinal rods 13, 14 are oriented in different configurations, as described herein. The clamping screws (not shown) are coupled and screwed with threads of the U-shaped implant cavities of the selected bone screws to secure the spinal rods 13, 14 with the vertebrae V2. For example, the clamping screws capture the end 18 of the spinal rod 14 within the U-shaped implant cavities of the bone screws 30. The bone screw 40 is connected with the end 56 of the spinal rod 14. The end 20 of the spinal rod 14 is captured in the cavity 96 of the connector 90. The clip 50 is arranged in the cavity 68 of the reduction element 16 so that the spinal rod 14 is connected with the fastener 50. The tension is applied to the fastener 50 and the reduction element 16 translates with respect to the fastener 50, in the direction represented by the arrow C in FIG. translation movement at the end 20 of the spinal rod 14 along the attachment 50 to reduce the spinal rod 14 with the U-shaped implant cavity 43 of the bone screw 40 and to arrange the rod 14 with the screw 40. The translation of the spinal rod 14 along the fastener 50 applies a force of co in some embodiments, the clip 50 is detached from the bone screw 40 following the arrangement of the end 20 of the spinal rod 14 with the screw In some embodiments, the tension is applied to the clip 50 and the member 16 translates along the clip 50 to translate the pin 14 and / or or removing the receiving device from the screw 40 until the rod 14 is received. In some embodiments, the member 16 may reduce the rod 14 with the screw 40 incrementally or continuously. In some embodiments, the spinal implant system 10 may comprise a spinal structure comprising one or a plurality of spinal structures 12 which may each be attached with a selected vertebral level of the vertebrae V or two or more selected vertebral levels of the vertebrae V The spinal correction system 10 accepts growth of the vertebrae of a selected section of the spine for correction treatment to treat various vertebral pathologies, such as, for example, adolescent idiopathic scoliosis and Scheuermann's kyphosis. In one embodiment, the spinal correction system 10 comprises an agent that can be arranged, packaged, coated, or layered within, on, or around the components and / or surfaces of the spinal correction system 10. In some embodiments, the agent may comprise a bone growth promoting material, such as, for example, a bone graft to improve attachment of the components and / or surfaces of the spinal correction system 10 with the vertebrae. In some embodiments, the agent may include one or a plurality of therapeutic agents and / or pharmacologic agents for release, including sustained release, to treat for example, pain, inflammation and degeneration. At the end of the procedure, the surgical instruments, sets and non-implanted components of the spinal correction system 10 are removed and the incision is closed. The spinal correction system 10 can be made with radiolucent materials such as polymers. Radiolabels may be included for X-ray, X-ray, CT or other imaging techniques. In some embodiments, the use of surgical, microsurgical, and image-guided navigation technologies to access, view, and repair spinal deterioration or spinal damage may be provided using the spinal correction system. In some embodiments, the spinal correction system 10 may include one or a plurality of plates, connectors, and / or bone fixtures for use with a single vertebral level or a plurality of vertebral levels. In one embodiment, as shown in FIGS. 7 to 11, the spinal correction system 10, similar to the systems and methods described with respect to FIGS. 1 to 6, comprises a spinal structure 212, similar to the spinal structure 12 described by 1 to 6. The spinal structure 212 comprises an implant, such as, for example, the spinal rod 14 and a reduction element, such as, for example, a tensioning device 216.
[0013] The tensioning device 216 is connected with the spinal rod 14 via a connector and can be engaged with the clip 50. The tensioning device 216 comprises a body 218 extending between an end 219 and an end 221. The body 218 has a cylindrical configuration. The body 218 includes an inner surface 266 defining a passageway 268 extending through a length of the tensioning device 216 configured to arrange the clip 50. The body 218 includes an arm 220 extending in an angular orientation from of the last. The arm 220 is pivotally connected to the body 218 so that the arm 220 is pivotable relative to the body 218 between a first configuration as shown in Fig. 7 and a second configuration as shown in Fig. 11. In some embodiments, the arm 220 is resiliently biased in the second configuration. The arm 220 includes a latch 280, similar to the snap 80 described herein, extending into the cavity 268 and engageable with the clip 50 to resist the movement of the tensioner 216 relative to the clip 50 in a direction represented by the arrow G in FIG. 7. The detent 280 comprises a series of teeth 281 that can frictionally engage the fastener 50 to facilitate the movement of the device 216, in the direction represented by FIG. arrow I, as described here. Actuation of the arm 220 via a force applied to the arm 220, in a direction shown by the arrow H in FIG. 7, engages the teeth 281 of the latch 280 with the clip 50. The clip 50 is pulled through the passageway 268 of the tensioning device 216, in the direction represented by the arrow G, so that the tensioning device 216 translates with respect to and along the fastener 50, in the the direction shown by the arrow I in FIG. 7. The tensioning device 216, similar to the reduction element 16 described here, can translate with respect to the fastener 50 so as to arrange the spinal rod 14 with a bone screw 140. The spinal structure 212 comprises a connector, such as for example a C-shaped clamp 290 connected to the spinal rod 14 and engageable with the clip 50, similar to the connector 90 described herein. The C-shaped clip 290 connects the spinal rod 14 with the clip 50 so that the spinal rod 14 is movable along the clip 50. The C-shaped clip 290 includes an inner surface 292 defining a cavity 294 configured to arrange the spinal rod 14. The C-shaped clamp 290 comprises a locking member, such as for example a screw 296. The screw 296 is threadingly engaged with the C-shaped clip 290. With the rod spinal 214 arranged in the cavity 294, the screw 296 translates into engagement with the spinal rod 14 so that the spinal rod 14 is captured in the cavity 294. The C-shaped gripper 290 comprises a portion of hook 298 that can be arranged around the clip 50, coupling the clip 50 with the C-shaped clip 290 so that the C-shaped clip 290, which is engaged with the spinal rod 14, can perform a translation movement along the clip 50. The hook portion 298 includes a grooved inner surface 299, as shown in FIG. 8. In some embodiments, the surface 299 is smooth or even. The clip 50 is engaged with the bone screw 140, similar to the bone screw 40 described herein. In one embodiment, as shown in Fig. 10, a head 142 of the bone screw 140 includes a pivot 148 which rotates about an axis A2 so that the head 142 is rotatable relative to a rod 144, the direction represented by the arrows A. The pivot 148 has a disk-shaped configuration. In some embodiments, the pivot 148 is formed differently, such as those variants described herein. The pivot 148 comprises an anchor 160 connected to the end 56 of the fastener 50 which rotates the fastener 50 about an axis A3 with respect to the pivot 148, in the direction represented by the arrows B. The anchor 160 comprises a pair of spaced apart ends 162 attached to the pivot 148 and a post 164 disposed therebetween. The amount 164 is rotatably engaged at the ends 162.
[0014] The clip 50 is connected to the post 164 so that the head 142 rotates the clip 50 in a plurality of axial orientations relative to the rod 144. In one embodiment, as shown in FIG. 148 does not include a pivot 148 and the anchor 160 comprises a first end comprising an opening 161 and a second end comprising an opening 163. A passageway 165 is arranged between the openings 161 and 163. The openings 161, 163 and the passageway 165 are configured for insertion and arrangement of the clip 50. In operation, the bone screw 140 is connected with the end 56 of the clip 50 via the anchor 160. The bone screw 140 is connected with the spinal tissue in a configuration to penetrate the spinal tissue. The bone screw 30 (Fig. 1) is connected with the spinal tissue and away from the bone screw 140. The end 20 of the spinal rod 14 is captured in the cavity 294 of the C-shaped clip 290. The fastener 50 is arranged in the hook portion 298 of the C-shaped clamp 290 and in the cavity 268 of the tensioner 216.
[0015] The snap 280 is engaged with the clip 50. A force is applied to the arm 220, in the direction shown by the arrow H, to engage the teeth 281 of the snap 280 with the clip 50. The fastener 50 is pulled by the passageway 268 of the tensioning device 216, in the direction shown by the arrow G, so that the tensioning device 216 translates with respect to and along the fastener. 50, in the direction represented by the arrow I. The translation of the tensioning device 216 along the fastener 50 engages the tensioning device 216 with the C-shaped gripper 290 to apply a force to the shaped clip C 290, in the direction represented by the arrow I. When the tensioning device 216 pulls the fastener, the tensioning device 216 causes a translational movement to the C-shaped gripper 290, which is coupled to the rod spinal 14, along the clip 50 so arranging the spinal rod 14 with the bone screw 140. Releasing the force applied to the arm 220 allows the arm 220 to rotate from the first configuration to the second configuration. The arm 220 is actuated several times and released only when the C-shaped clamp 290 is arranged with the bone screw 140. The translation of the spinal rod 14 along the clip 50 arranges the spinal rod 14 adjacent to the vertebrae on a surgical site for connection to the vertebrae, which applies a correction force on the vertebrae to selectively align the vertebrae, as described herein. In some embodiments, the tensioning device 216 is monolithically formed with, connected to, or securely attached via fasteners to the C-shaped gripper 290. It should be understood that various modifications can be made to the embodiment described here. Therefore, the above description should not be construed as limiting, but merely by way of illustration of the various embodiments. Those skilled in the art will consider further modifications in the scope and spirit of the appended claims.

权利要求:
Claims (10)
[0001]
REVENDICATIONS1. A spinal structure (12) comprising: a spinal rod (14); and a reduction member (16) connected with the spinal rod (14) and engageable with a clip (50) connected to the spinal rod (14), the reduction member (16) being able to translate relative to the clip (50) to arrange the spinal rod (f4) with a fastener (40) configured to penetrate the tissue. 10
[0002]
The spinal structure (12) of claim 1, wherein the reduction member (16) comprises a detent (80) engageable with the clip (50); or wherein the reduction member (16) comprises a crimp (70) which resists the movement of the reduction member (16) in at least one direction, the crimp (70) preferably including an inner surface (66). ) having at least one penetrating member (72) engageable with the fastener (50) to resist movement in the at least one direction.
[0003]
The spinal structure (12) of claim 1 or 2, wherein the reduction member (16) is configured to translate in a first axial direction and to experience resistance to translation of the element. reduction device (16) in a second axial direction.
[0004]
Spinal structure (12) according to one of claims 1 to 3, wherein the reduction element (16) comprises a connector (90) defining a cavity (96) configured to arrange the spinal rod (14) and coupling the spinal rod (14) with the clip (50).
[0005]
The spinal structure (12) according to one of claims 1 to 4, wherein the spinal rod (14) comprises a first end (18) attached to a bone screw (30) attached to vertebrae and a second end (20) connected with the fastener (4a).
[0006]
The spinal structure (12) according to one of claims 1 to 5, wherein the attachment (40) comprises a head (42) and a shaft (44) for penetrating the tissue, the head (42) being rotatable by relative to the rod (44); and wherein, preferably; The head (142) includes a pivot (148) which rotates about a stem axis (144) and an anchor (160) connected to the clip (50) which rotates the clip (50) about an anchor pin (A3) with respect to the pivot (148); the head (142) preferably rotating the fastener (50) in a plurality of axial orientations relative to the shank (144).
[0007]
7. spinal structure (12) according to one of claims 1 to 6, wherein the fastener (50) comprises a loop wound around the spinal rod (14).
[0008]
A spinal implant system (10) comprising the spinal structure (12) according to one of claims 1 to 7, as well as the fastener (50); and wherein, preferably, the reduction member (16) is movable in a first direction relative to the clip (50) to effect translational movement to the spinal structure (12) to a position adjacent to the attachment (40), and is locked in its movement in a second direction.
[0009]
The spinal implant system (10) according to claim 8, wherein the reduction member (16) comprises a tensioning device (216) engageable with the clip (50), the tensioning device (216) preferably comprising a snap (280) which pulls the clip (50) through the tensioning device (216).
[0010]
The spinal implant system (10) according to one of claims 8 to 9, wherein the clip (50) comprises a strip.

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法律状态:
2015-12-17| PLFP| Fee payment|Year of fee payment: 2 |

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2016-12-27| PLFP| Fee payment|Year of fee payment: 3 |

2017-12-27| PLFP| Fee payment|Year of fee payment: 4 |

2018-03-02| PLSC| Publication of the preliminary search report|Effective date: 20180302 |

2019-11-20| PLFP| Fee payment|Year of fee payment: 6 |

2020-11-20| PLFP| Fee payment|Year of fee payment: 7 |

2021-11-18| PLFP| Fee payment|Year of fee payment: 8 |

优先权:

申请号 | 申请日 | 专利标题

US14104131|2013-12-12|

US14/104,131|US9872713B2|2013-12-12|2013-12-12|Spinal correction system and method|

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