US20160262798A1 - Spinal construct and method - Google Patents

Spinal construct and method Download PDF

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Publication number
US20160262798A1
US20160262798A1 US14/645,179 US201514645179A US2016262798A1 US 20160262798 A1 US20160262798 A1 US 20160262798A1 US 201514645179 A US201514645179 A US 201514645179A US 2016262798 A1 US2016262798 A1 US 2016262798A1
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United States
Prior art keywords
fastener
spinal construct
connector
members
construct
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
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US14/645,179
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US20170065302A9 (en
Inventor
William Alan Rezach
Jason M. May
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Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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Publication date
Application filed by Warsaw Orthopedic Inc filed Critical Warsaw Orthopedic Inc
Priority to US14/645,179 priority Critical patent/US20170065302A9/en
Publication of US20160262798A1 publication Critical patent/US20160262798A1/en
Publication of US20170065302A9 publication Critical patent/US20170065302A9/en
Priority to US15/499,447 priority patent/US10188427B2/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7014Longitudinal elements, e.g. rods with means for adjusting the distance between two screws or hooks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7004Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7019Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7025Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a sliding joint

Definitions

  • the present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and method for treating a spine.
  • Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, 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 pain, nerve damage, and partial or complete loss of mobility.
  • 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.
  • spinal constructs which include implants such as bone fasteners, connectors, plates and vertebral rods, are often used to provide stability to a treated region. These implants can redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support the vertebral members.
  • Surgical instruments are employed, for example, to engage the fasteners for attachment to the exterior of two or more vertebral members. This disclosure describes an improvement over these prior art technologies.
  • a spinal construct including a first fastener, a second fastener and a connector.
  • Each fastener includes a first end and a second end configured for penetrating tissue.
  • the connector has a first end including a first expandable member and a second end including a second expandable member. The first end of each fastener can engage with the expandable members of the connector to fix the fasteners to the connector. The first end and the second end of the connector are joined by a bridge.
  • a spinal construct including a first fastener, a second fastener, a connector and securing members for attaching the connector to the first and second fastener.
  • a method for treating a spinal disorder includes implanting a spinal construct comprising a first fastener, a second fastener and a connector.
  • the connector utilized in this method has two ends, a first end including and first expandable member and a second end including a second expandable member.
  • the method includes securing the first end of the connector to the first fastener with a first securing member and securing the second end of the connector to the second fastener with a second securing member.
  • the method provided herein is for treating a spinal disorder, wherein the spinal construct conforms to the curvature of the spine.
  • FIG. 1 is a perspective view of components of one embodiment of a surgical implant system in accordance with the principles of the present disclosure
  • FIG. 2 is a perspective view of the components shown in FIG. 1 ;
  • FIG. 3 is a perspective view of the components shown in FIG. 1 ;
  • FIG. 4 is a perspective view of components of one embodiment of a surgical implant system in accordance with the principles of the present disclosure.
  • FIG. 5 is a perspective view of components of one embodiment of a surgical implant system in accordance with the principles of the present disclosure.
  • FIG. 6 is a cross-section of the components shown in FIG. 5 .
  • the exemplary embodiments of a surgical system are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical implant system and a method for treating a spine.
  • the system comprises a spinal construct and related methods of use, which include a pop on, snap on, click on and/or slide on member that provides a universal connection system to spine surgeons.
  • the spinal construct allows the use of a singular bone screw component with multiple types of receivers thereby minimizing inventory while creating assemblies customized for a specific patient.
  • the present system comprises a low profile pedicle screw construct.
  • the present system comprises a spinal construct having a single level construct that is aligned with the bone screws, which do not include an implant receiver or head.
  • the single level spinal construct as described herein allows an intervertebral rod or connector to be disposed in-plane or in-line with the top of a bone screw or fastener instead of having a spinal rod lay on top of the bone screw sphere.
  • the construct includes at least one pop on, snap on, click on and/or slide on member that is engaged with a top of the bone screws or fasteners for fixation and/or locking therewith.
  • the screws include heads, such as, for example, spheres such that this configuration allows a spinal rod of the construct to be in-plane or in-line with the screw spheres.
  • the present system comprises a single vertebral level pop on construct.
  • the construct includes a first end having a pop on member, such as, for example, a receiver.
  • the pop on member in some embodiments, includes an expandable member, for example an expansion chamber configured for disposal of a retaining member or crown and a ring.
  • the ring is expandable to facilitate receiving a sphere of a bone screw within the chamber and then retracts or contracts to fix the sphere within the first end of the connector of the construct.
  • the sphere is seated with the crown in the expansion chamber in a retained configuration.
  • a set screw is threaded with the first end and engageable with crown to lock the screw with the construct.
  • the construct includes a connector having a first end having a pop on member and a second end having a pop on member, as described herein.
  • the construct includes securing members, for example set screws, for engagement with the first end and the second end, as described herein.
  • the construct is employed with a method such that bone screws are positioned with surgical site adjacent vertebrae.
  • the construct is aligned with the bone screws or fasteners, which can be implanted into one level of the spine.
  • the construct comprises a single vertebral level construct and includes a first end that is snapped onto a first bone screw and a second end that is snapped onto a second bone screw.
  • the construct includes set screws that are fixed with the end of the construct to tighten the screws with the construct.
  • the construct has a low profile configuration comprising a 4-5 millimeter profile compared with multi-axial pedicle screws.
  • the construct comprises an adjustable element for a multi-span single vertebral level construct, which includes a first member that is translatable relative to a second member.
  • the second member is axially translatable relative to the first member and is slidable along a longitudinal axis of the construct.
  • the second member is rotatable relative to the first member about the longitudinal axis.
  • the second member is selectively axially translatable relative to the first member and the construct includes a set screw that fixes relative position of the members, as described herein.
  • the second member is engageable with the first member to selectively prevent rotation of the second member relative to the first member.
  • the first member and/or the second member includes a receiver having at least one pop on, snap on, click on and/or slide on member that is engaged with screws for fixation and/or locking therewith.
  • at least one of the members includes a C shaped receiver that allows a spinal rod to be inserted from a medial and/or lateral direction.
  • the system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures.
  • spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures.
  • the system the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics.
  • the disclosed system 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, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions.
  • the system of 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 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.
  • 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”.
  • 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.
  • 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).
  • 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.
  • 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.
  • tissue includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.
  • FIGS. 1-6 there are illustrated components of a surgical implant system comprising a spinal construct 100 , in accordance with the principles of the present disclosure.
  • the components of spinal construct 100 can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites.
  • the components of system 10 individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, 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., SKELITETM manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO 4 polymeric rubbers, polyethylene tere
  • Various components of 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 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 system 10 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.
  • the surgical implant system includes a spinal construct 100 , which is employed, for example, with an open or mini-open, minimal access and/or minimally invasive including percutaneous surgical technique for implantation at a surgical site within a body of a patient, for example, a section of a spine.
  • the components of surgical system are configured for fixation with tissue for a surgical treatment to treat various spine pathologies, such as those described herein.
  • a spinal construct 100 including a first fastener 110 , a second fastener 120 and a connector 140 .
  • Fastener 110 includes a first end 112 and a second end 114 configured for penetrating tissue.
  • the first end 112 and second end 114 of first fastener 110 are connected to each other by a shank 116 having an outer surface, which in some embodiments is threaded to allow the fastener to function as a bone screw, for example, a pedicle screw.
  • Second fastener 120 includes a first end 122 and a second end 124 configured for penetrating tissue.
  • first end 122 and second end 124 of second fastener 120 are connected to each other by a shank 126 having an outer surface, which in some embodiments is threaded to allow the fastener to function as a bone screw, for example, a pedicle screw.
  • Connector 140 has a first end 150 and a second end 170 .
  • the first end 150 of connector 140 includes a first expandable member 152 and the second end 170 includes a second expandable member 172 , both configured to receive the first end 112 of fastener 110 or the first end 122 of fastener 120 to fix each fastener to connector 140 .
  • the first end 112 of fastener 110 can be rounded and configured to fit within an interior cavity of the first expandable member while allowing rotation and articulation of fastener 110 .
  • shank 116 can have a cylindrical shaft configuration.
  • securing members 190 and 192 secure connector 140 to the first and second fastener, respectively.
  • first end 150 and second end 170 of connector 150 is joined by a bridge 160 disposed between the two connector ends.
  • Bridge 160 comprises an adjustable length between first end 150 and second end 170 of connector 140 .
  • the respective cross-sectional geometry of bridge 160 may have various configurations, for example, round, oval, rectangular, irregular, consistent, variable, uniform and non-uniform.
  • Bridge 160 can have various cross-sectional area, geometry, material or material property such as strength, modulus or flexibility.
  • connector 140 can be monolithic and the connector including first end 150 and second end 170 can be one piece.
  • bridge 160 of connector 140 comprises an axis A-A which is perpendicular to the longitudinal axes L 1 and L 2 of the first and second fastener, respectively.
  • each securing member can be a set screw.
  • the spinal construct 100 may be part of a larger orthopedic system comprising a plurality of longitudinal members (e.g., rods, plates, etc.), a plurality of bone fasteners, and/or a plurality of connectors.
  • the spinal construct 100 is particularly suited for use in the spinal column. It will be understood that various types of connectors (e.g., clamps) can be used in combination with the spinal construct 100 .
  • Shank 116 of fastener 110 defines a longitudinal axis L 1 and is configured for fixation to spinal vertebrae.
  • Shank 126 of fastener 120 defines a longitudinal axis L 2 and is configured for fixation to spinal vertebrae. It is contemplated that fastener 110 and/or fastener 120 may include alternate bone fixation elements, such as, for example, a nail configuration, barbs, and/or expanding elements.
  • fastener 110 can be variously dimensioned, for example, with regard to length, width, diameter and thickness. It is further contemplated that the respective cross-sectional geometry of fastener 110 may have various configurations, for example, round, oval, rectangular, irregular, consistent, variable, uniform and non-uniform. Fastener 110 may have a different cross-sectional area, geometry, material or material property such as strength, modulus or flexibility relative to shank 116 .
  • spinal construct 100 can have a low profile of from about 4 mm to about 5 mm, lower than a majority of other spinal constructs utilizing multiple axial pedicle screws.
  • the medical practitioner places fasteners 110 and 120 in a location appropriate for treating a spinal disorder. Subsequently, the surgeon can snap on the single level construct 100 onto fasteners 110 and 120 and tightened connector 140 with securing members 190 and 192 , for example set screws.
  • FIG. 2 illustrates the securing members 190 and 192 engaging connector 140 , which engages fasteners 110 and 120 .
  • Securing members 190 and 192 can be turned so that connector 140 can pop or snap onto fasteners 110 and 120 .
  • the securing members can be removed from connector 140 by a hand tool or by hand, for example, by rotating the security members in a reverse direction.
  • a tightened spinal construct 100 that has a low profile is illustrated in FIG. 3 .
  • bridge 260 of connector 240 comprises a coupling member 262 , for example, a set screw, fixedly attached to the first end 250 of connector 240 .
  • coupling member 262 is configured to receive second end 270 of connector 240 .
  • Second end 270 of connector 240 can have various configurations.
  • second end 270 can be threaded to function as a screw so as to rotate freely within coupling member 262 .
  • second end 270 of connector 240 can be configured to engage slidably the first end 250 of connector 240 .
  • Each end of connector 240 comprises an expandable member (not shown in FIG.
  • Each end of connector 240 defines a hole configured to receive a securing member, such as a set screw, and the hole can also receive the head of the fastener (e.g., bone screw), in some embodiments, the head is disposed opposite the securing member.
  • a securing member such as a set screw
  • the head of the fastener e.g., bone screw
  • first end 250 of connector 240 defines hole 252
  • second end 270 of connector 240 defines hole 272 .
  • second end 270 can rotate around the latitudinal axis of connector 240 and upon tightening, can also be used to prevent rotation once connector 240 is positioned in a desired location at a desired configuration.
  • bridge 260 can adjust to different lengths to extend or contract to the size of a vertebra.
  • the bridge of the connector can selectively extend to the desired length.
  • the coupling member 262 can extend or contract by a friction fitting between the bridge and the expandable members.
  • spinal construct 300 comprises a first expandable member 352 disposed in the first end 350 of connector 340 .
  • a second expandable member 372 is disposed in the second end 370 of connector 340 .
  • Each expandable member can comprise an expansion chamber having two ends; at one end, the expandable member comprises a retaining member 356 , 376 and an inner locking ring, 354 and 374 and at the other end, the expandable member defines a hole 380 , 382 to receive a securing member 390 , 392 .
  • Retaining members 356 and 376 can be expandable and are configured to receive the first end of the first fastener and/or the first end of the second fastener (not shown).
  • Each retaining member 356 , 376 of expandable members 352 , 372 can have various forms comprising a triangle, trapezoid, hexagon, circle, semi-circle, ellipse, rectangle, square or crown shaped adapted for receiving a similarly shaped first end of first and/or second fastener.
  • expandable members 352 , 372 define holes 380 , 382 configured to receive securing members 390 , 392 for attaching the connector 340 onto bone screws or fasteners.
  • securing members 390 and 392 can be set screws.
  • each expandable member 352 , 372 also comprise a notch 358 , 378 configured for receiving an inner locking ring therein. These expandable members are at opposite ends of bridge 360 .
  • Each inner locking ring, 354 and 374 can be expandable.
  • inner locking rings 354 , 374 can be made of silicone having a hardness from about 40 durameter to about 80 durameter. In use, when retaining members 356 and 376 contact the first end of a fastener (not shown), they expand radially and then collapse back to their original form thereby being able to engage the first end of a fastener into a tight grip.
  • the inner locking ring is pushed into the notch of the expandable member to provide a tight fit with the fastener. It will be understood that other mechanisms can be used including friction fit or locking assemblies to lock the connector on the head of the fastener.
  • First end 350 and second end 370 of connector 340 can have many different shapes, for example spherical, truncated spherical, cylindrical and the like.
  • end 350 and end 370 can be substantially C-shaped, having an upper leg, a lower leg including a foot portion extending from one end thereof, and an intermediate portion joining upper and lower legs opposite of foot portion.
  • Each end 350 and/or 370 can define a mouth between the upper leg and the foot portion that is opposite intermediate portion of the C-shaped end. The mouth opens into upper passage portion extending through first end 350 and/or second end 370 , with upper passage portion extending in an orthogonal relationship to the longitudinal axis of a fastener.
  • Upper leg has a threaded aperture into which an engaging member, for example a set screw can be threadingly engaged.
  • the surgical implant system including spinal construct 100 or 300 is employed with a surgical procedure for treatment of a spinal disorder affecting a section of a spine of a patient, as discussed herein.
  • the spinal construct 100 or 300 may also be employed with other surgical procedures. It is contemplated that the surgical implant system including spinal construct 100 or 300 is attached to spinal vertebrae for fusion and/or dynamic stabilization applications of the affected section of the spine to facilitate healing and therapeutic treatment, while providing flexion, extension and/or torsion capabilities.
  • a medical practitioner obtains access to a surgical site including spinal vertebrae in any appropriate manner, such as through incision and retraction of tissues.
  • the surgical implant system including spinal construct 100 or 300 may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby spinal vertebrae are 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. The surgical implant system including spinal construct 100 or 300 is then employed to augment the surgical treatment.
  • the surgical implant system including spinal construct 100 or 300 can be delivered or implanted as a pre-assembled device or can be assembled in situ.
  • the surgical implant system may be completely or partially revised, removed or replaced, for example, replacing the connector and/or one or all of the components of spinal construct 100 or 300 .
  • Spinal construct 100 or 300 may be employed with a bone screw, pedicle screw or multi-axial screw used in spinal surgery. It is contemplated that spinal construct 100 or 300 may be coated with an osteoconductive material such as hydroxyapatite and/or osteoinductive agent such as a bone morphogenetic protein for enhanced bony fixation. Spinal construct 100 or 300 can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. Metallic or ceramic radiomarkers, such as tantalum beads, tantalum pins, titanium pins, titanium endcaps and platinum wires can be used, such as being disposed at the end portions of vertebral rod.
  • the spinal construct 100 or 300 may be employed with a vertebral rod or connector(s) having an arcuate configuration and an increased length providing the ability to extend over two or more intervertebral elements. It is contemplated that the configuration of the surgical implant system may provide load sharing, dynamic and/or flexible stabilization over a plurality of intervertebral levels, including treated and untreated vertebral and intervertebral levels.
  • the spinal construct includes an agent, which includes a bone growth promoting material, which may be disposed, packed or layered within, on or about the components and/or surfaces thereof.
  • the bone growth promoting material such as, for example, bone graft can be a particulate material, which may include an osteoconductive material such as hydroxyapatite and/or an osteoinductive agent such as a bone morphogenic protein (BMP) to enhance bony fixation of spinal construct 100 or 300 with the adjacent vertebrae.
  • BMP bone morphogenic protein
  • a method for treating a spinal disorder includes implanting a spinal construct comprising a first fastener, a second fastener and a connector.
  • the connector utilized in this method has two ends, a first end including and first expandable member and a second end including a second expandable member. Each expandable member of the connector is engageable with and can be snapped onto the first end of each fastener.
  • the method includes securing the first end of the connector to the first fastener with a first securing member and securing the second end of the connector to the second fastener with a second securing member.
  • the method provided herein is for treating a spinal disorder, wherein the spinal construct conforms to the curvature of the spine.
  • the at least two bone screws are implanted into at least one or more vertebrae and the connector is attached to the heads of each bone screw so that the connector pops or snaps on the head of the bone screw. In this way, the connector can easily be applied to the bone screw.

Abstract

A spinal construct is provided including a first fastener, a second fastener and a connector. Each fastener includes a first end and a second end configured for penetrating tissue. The connector has two ends. Each end of the connector includes an expandable member. The first end of each fastener is engageable to an expandable member of the connector to fix the fastener to the connector. The first and second ends of the connector are connected by a bridge. The spinal construct also includes securing members for attaching the connector to the fasteners. A method for treating a spinal disorder with the spinal construct is also provided.

Description

    TECHNICAL FIELD
  • The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and method for treating a spine.
  • BACKGROUND
  • Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, 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 pain, nerve damage, and partial or complete loss of mobility.
  • 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, which include implants such as bone fasteners, connectors, plates and vertebral rods, are often used to provide stability to a treated region. These implants can redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support the vertebral members. Surgical instruments are employed, for example, to engage the fasteners for attachment to the exterior of two or more vertebral members. This disclosure describes an improvement over these prior art technologies.
  • SUMMARY
  • In one embodiment, a spinal construct is provided including a first fastener, a second fastener and a connector. Each fastener includes a first end and a second end configured for penetrating tissue. The connector has a first end including a first expandable member and a second end including a second expandable member. The first end of each fastener can engage with the expandable members of the connector to fix the fasteners to the connector. The first end and the second end of the connector are joined by a bridge.
  • In another embodiment, a spinal construct is provided including a first fastener, a second fastener, a connector and securing members for attaching the connector to the first and second fastener.
  • In other embodiments, a method for treating a spinal disorder is provided. The method includes implanting a spinal construct comprising a first fastener, a second fastener and a connector. The connector utilized in this method has two ends, a first end including and first expandable member and a second end including a second expandable member. After the spinal construct is implanted, the method includes securing the first end of the connector to the first fastener with a first securing member and securing the second end of the connector to the second fastener with a second securing member. In various embodiments, the method provided herein is for treating a spinal disorder, wherein the spinal construct conforms to the curvature of the spine.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:
  • FIG. 1 is a perspective view of components of one embodiment of a surgical implant system in accordance with the principles of the present disclosure;
  • FIG. 2 is a perspective view of the components shown in FIG. 1;
  • FIG. 3 is a perspective view of the components shown in FIG. 1;
  • FIG. 4 is a perspective view of components of one embodiment of a surgical implant system in accordance with the principles of the present disclosure; and
  • FIG. 5 is a perspective view of components of one embodiment of a surgical implant system in accordance with the principles of the present disclosure.
  • FIG. 6 is a cross-section of the components shown in FIG. 5.
  • DETAILED DESCRIPTION
  • The exemplary embodiments of a surgical system are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical implant system and a method for treating a spine. In some embodiments, the system comprises a spinal construct and related methods of use, which include a pop on, snap on, click on and/or slide on member that provides a universal connection system to spine surgeons. In some embodiments, the spinal construct allows the use of a singular bone screw component with multiple types of receivers thereby minimizing inventory while creating assemblies customized for a specific patient.
  • In one embodiment, the present system comprises a low profile pedicle screw construct. In some embodiments, the present system comprises a spinal construct having a single level construct that is aligned with the bone screws, which do not include an implant receiver or head. The single level spinal construct as described herein allows an intervertebral rod or connector to be disposed in-plane or in-line with the top of a bone screw or fastener instead of having a spinal rod lay on top of the bone screw sphere. The construct includes at least one pop on, snap on, click on and/or slide on member that is engaged with a top of the bone screws or fasteners for fixation and/or locking therewith. In some embodiments, the screws include heads, such as, for example, spheres such that this configuration allows a spinal rod of the construct to be in-plane or in-line with the screw spheres.
  • In one embodiment, the present system comprises a single vertebral level pop on construct. In this embodiment, the construct includes a first end having a pop on member, such as, for example, a receiver. The pop on member, in some embodiments, includes an expandable member, for example an expansion chamber configured for disposal of a retaining member or crown and a ring. The ring is expandable to facilitate receiving a sphere of a bone screw within the chamber and then retracts or contracts to fix the sphere within the first end of the connector of the construct. The sphere is seated with the crown in the expansion chamber in a retained configuration. A set screw is threaded with the first end and engageable with crown to lock the screw with the construct. In some embodiments, the construct includes a connector having a first end having a pop on member and a second end having a pop on member, as described herein. In some embodiments, the construct includes securing members, for example set screws, for engagement with the first end and the second end, as described herein.
  • In one embodiment, the construct is employed with a method such that bone screws are positioned with surgical site adjacent vertebrae. The construct is aligned with the bone screws or fasteners, which can be implanted into one level of the spine. In some embodiments, the construct comprises a single vertebral level construct and includes a first end that is snapped onto a first bone screw and a second end that is snapped onto a second bone screw. The construct includes set screws that are fixed with the end of the construct to tighten the screws with the construct. In one embodiment, the construct has a low profile configuration comprising a 4-5 millimeter profile compared with multi-axial pedicle screws.
  • In one embodiment, the construct comprises an adjustable element for a multi-span single vertebral level construct, which includes a first member that is translatable relative to a second member. In one embodiment, the second member is axially translatable relative to the first member and is slidable along a longitudinal axis of the construct. In one embodiment, the second member is rotatable relative to the first member about the longitudinal axis. In one embodiment, the second member is selectively axially translatable relative to the first member and the construct includes a set screw that fixes relative position of the members, as described herein. In one embodiment, the second member is engageable with the first member to selectively prevent rotation of the second member relative to the first member. In one embodiment, the first member and/or the second member includes a receiver having at least one pop on, snap on, click on and/or slide on member that is engaged with screws for fixation and/or locking therewith. In one embodiment, at least one of the members includes a C shaped receiver that allows a spinal rod to be inserted from a medial and/or lateral direction.
  • In some embodiments, the system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the system 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 system 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, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The system of 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 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.
  • The system of 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, in some embodiments, 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”.
  • 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.
  • The following discussion includes a description of a surgical system including a surgical instrument, related components and methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to FIGS. 1-6, there are illustrated components of a surgical implant system comprising a spinal construct 100, in accordance with the principles of the present disclosure.
  • The components of spinal construct 100 can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of system 10, individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, 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-BaSO4 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, elastometic 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 polylactide, polyglycolide, polytyrosine carbonate, polycaprolactone and their combinations. Various components of 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 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 system 10 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.
  • The surgical implant system includes a spinal construct 100, which is employed, for example, with an open or mini-open, minimal access and/or minimally invasive including percutaneous surgical technique for implantation at a surgical site within a body of a patient, for example, a section of a spine. In one embodiment, the components of surgical system are configured for fixation with tissue for a surgical treatment to treat various spine pathologies, such as those described herein.
  • With reference to FIGS. 1-3, in an embodiment, there is provided a spinal construct 100 including a first fastener 110, a second fastener 120 and a connector 140. Fastener 110 includes a first end 112 and a second end 114 configured for penetrating tissue. The first end 112 and second end 114 of first fastener 110 are connected to each other by a shank 116 having an outer surface, which in some embodiments is threaded to allow the fastener to function as a bone screw, for example, a pedicle screw. Second fastener 120 includes a first end 122 and a second end 124 configured for penetrating tissue. The first end 122 and second end 124 of second fastener 120 are connected to each other by a shank 126 having an outer surface, which in some embodiments is threaded to allow the fastener to function as a bone screw, for example, a pedicle screw.
  • Connector 140 has a first end 150 and a second end 170. The first end 150 of connector 140 includes a first expandable member 152 and the second end 170 includes a second expandable member 172, both configured to receive the first end 112 of fastener 110 or the first end 122 of fastener 120 to fix each fastener to connector 140. The first end 112 of fastener 110 can be rounded and configured to fit within an interior cavity of the first expandable member while allowing rotation and articulation of fastener 110. In some embodiments, shank 116 can have a cylindrical shaft configuration. In various embodiments, securing members 190 and 192 secure connector 140 to the first and second fastener, respectively. In certain embodiments, the first end 150 and second end 170 of connector 150 is joined by a bridge 160 disposed between the two connector ends. Bridge 160, in some embodiments, comprises an adjustable length between first end 150 and second end 170 of connector 140. It is contemplated that the respective cross-sectional geometry of bridge 160 may have various configurations, for example, round, oval, rectangular, irregular, consistent, variable, uniform and non-uniform. Bridge 160 can have various cross-sectional area, geometry, material or material property such as strength, modulus or flexibility. In some embodiments, connector 140 can be monolithic and the connector including first end 150 and second end 170 can be one piece.
  • With further reference to FIG, 1, in various embodiments, bridge 160 of connector 140 comprises an axis A-A which is perpendicular to the longitudinal axes L1 and L2 of the first and second fastener, respectively.
  • In some embodiments, each securing member can be a set screw. The spinal construct 100 may be part of a larger orthopedic system comprising a plurality of longitudinal members (e.g., rods, plates, etc.), a plurality of bone fasteners, and/or a plurality of connectors. In some embodiments, the spinal construct 100 is particularly suited for use in the spinal column. It will be understood that various types of connectors (e.g., clamps) can be used in combination with the spinal construct 100.
  • Shank 116 of fastener 110 defines a longitudinal axis L1 and is configured for fixation to spinal vertebrae. Shank 126 of fastener 120 defines a longitudinal axis L2 and is configured for fixation to spinal vertebrae. It is contemplated that fastener 110 and/or fastener 120 may include alternate bone fixation elements, such as, for example, a nail configuration, barbs, and/or expanding elements.
  • It is contemplated that fastener 110 can be variously dimensioned, for example, with regard to length, width, diameter and thickness. It is further contemplated that the respective cross-sectional geometry of fastener 110 may have various configurations, for example, round, oval, rectangular, irregular, consistent, variable, uniform and non-uniform. Fastener 110 may have a different cross-sectional area, geometry, material or material property such as strength, modulus or flexibility relative to shank 116.
  • In some embodiments, as illustrated in FIGS. 1-3, as a result of this application, spinal construct 100 can have a low profile of from about 4 mm to about 5 mm, lower than a majority of other spinal constructs utilizing multiple axial pedicle screws. In use, the medical practitioner, places fasteners 110 and 120 in a location appropriate for treating a spinal disorder. Subsequently, the surgeon can snap on the single level construct 100 onto fasteners 110 and 120 and tightened connector 140 with securing members 190 and 192, for example set screws. FIG. 2 illustrates the securing members 190 and 192 engaging connector 140, which engages fasteners 110 and 120. Securing members 190 and 192 (e.g., set screws) can be turned so that connector 140 can pop or snap onto fasteners 110 and 120. The securing members can be removed from connector 140 by a hand tool or by hand, for example, by rotating the security members in a reverse direction. A tightened spinal construct 100 that has a low profile is illustrated in FIG. 3.
  • With reference to FIG. 4, in various embodiments, bridge 260 of connector 240 comprises a coupling member 262, for example, a set screw, fixedly attached to the first end 250 of connector 240. At an end opposite first end of connector 240, coupling member 262 is configured to receive second end 270 of connector 240. Second end 270 of connector 240 can have various configurations. For example, second end 270 can be threaded to function as a screw so as to rotate freely within coupling member 262. In other embodiments, second end 270 of connector 240 can be configured to engage slidably the first end 250 of connector 240. Each end of connector 240 comprises an expandable member (not shown in FIG. 4) at one end configured to engage the first end of a bone screw or fastener. Each end of connector 240 defines a hole configured to receive a securing member, such as a set screw, and the hole can also receive the head of the fastener (e.g., bone screw), in some embodiments, the head is disposed opposite the securing member. For example, first end 250 of connector 240 defines hole 252 and second end 270 of connector 240 defines hole 272. In use, second end 270 can rotate around the latitudinal axis of connector 240 and upon tightening, can also be used to prevent rotation once connector 240 is positioned in a desired location at a desired configuration.
  • It will be understood that bridge 260 can adjust to different lengths to extend or contract to the size of a vertebra. In some embodiments, the bridge of the connector can selectively extend to the desired length. In some embodiments, the coupling member 262 can extend or contract by a friction fitting between the bridge and the expandable members.
  • In various embodiments, with reference to FIGS. 5-6, spinal construct 300 comprises a first expandable member 352 disposed in the first end 350 of connector 340. A second expandable member 372 is disposed in the second end 370 of connector 340. Each expandable member can comprise an expansion chamber having two ends; at one end, the expandable member comprises a retaining member 356, 376 and an inner locking ring, 354 and 374 and at the other end, the expandable member defines a hole 380, 382 to receive a securing member 390, 392. Retaining members 356 and 376 can be expandable and are configured to receive the first end of the first fastener and/or the first end of the second fastener (not shown). Each retaining member 356, 376 of expandable members 352, 372 can have various forms comprising a triangle, trapezoid, hexagon, circle, semi-circle, ellipse, rectangle, square or crown shaped adapted for receiving a similarly shaped first end of first and/or second fastener. At the end opposite from the end configured to receive a fastener, expandable members 352, 372 define holes 380, 382 configured to receive securing members 390, 392 for attaching the connector 340 onto bone screws or fasteners. In some embodiments, securing members 390 and 392 can be set screws.
  • With further reference to FIG. 6, each expandable member 352, 372 also comprise a notch 358, 378 configured for receiving an inner locking ring therein. These expandable members are at opposite ends of bridge 360. Each inner locking ring, 354 and 374 can be expandable. In various embodiments, inner locking rings 354, 374 can be made of silicone having a hardness from about 40 durameter to about 80 durameter. In use, when retaining members 356 and 376 contact the first end of a fastener (not shown), they expand radially and then collapse back to their original form thereby being able to engage the first end of a fastener into a tight grip. Once, the first end of a fastener has been received by the retaining member at the end of the connector, the inner locking ring is pushed into the notch of the expandable member to provide a tight fit with the fastener. It will be understood that other mechanisms can be used including friction fit or locking assemblies to lock the connector on the head of the fastener.
  • First end 350 and second end 370 of connector 340 can have many different shapes, for example spherical, truncated spherical, cylindrical and the like. In certain embodiments, end 350 and end 370 can be substantially C-shaped, having an upper leg, a lower leg including a foot portion extending from one end thereof, and an intermediate portion joining upper and lower legs opposite of foot portion. Each end 350 and/or 370 can define a mouth between the upper leg and the foot portion that is opposite intermediate portion of the C-shaped end. The mouth opens into upper passage portion extending through first end 350 and/or second end 370, with upper passage portion extending in an orthogonal relationship to the longitudinal axis of a fastener. Upper leg has a threaded aperture into which an engaging member, for example a set screw can be threadingly engaged.
  • In assembly, operation and use, the surgical implant system including spinal construct 100 or 300 is employed with a surgical procedure for treatment of a spinal disorder affecting a section of a spine of a patient, as discussed herein. The spinal construct 100 or 300 may also be employed with other surgical procedures. It is contemplated that the surgical implant system including spinal construct 100 or 300 is attached to spinal vertebrae for fusion and/or dynamic stabilization applications of the affected section of the spine to facilitate healing and therapeutic treatment, while providing flexion, extension and/or torsion capabilities.
  • In use, to treat the affected section of the spine, a medical practitioner obtains access to a surgical site including spinal vertebrae in any appropriate manner, such as through incision and retraction of tissues. It is envisioned that the surgical implant system including spinal construct 100 or 300 may be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby spinal vertebrae are 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. The surgical implant system including spinal construct 100 or 300 is then employed to augment the surgical treatment. The surgical implant system including spinal construct 100 or 300 can be delivered or implanted as a pre-assembled device or can be assembled in situ. The surgical implant system may be completely or partially revised, removed or replaced, for example, replacing the connector and/or one or all of the components of spinal construct 100 or 300.
  • Spinal construct 100 or 300 may be employed with a bone screw, pedicle screw or multi-axial screw used in spinal surgery. It is contemplated that spinal construct 100 or 300 may be coated with an osteoconductive material such as hydroxyapatite and/or osteoinductive agent such as a bone morphogenetic protein for enhanced bony fixation. Spinal construct 100 or 300 can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. Metallic or ceramic radiomarkers, such as tantalum beads, tantalum pins, titanium pins, titanium endcaps and platinum wires can be used, such as being disposed at the end portions of vertebral rod.
  • It is envisioned that the spinal construct 100 or 300 may be employed with a vertebral rod or connector(s) having an arcuate configuration and an increased length providing the ability to extend over two or more intervertebral elements. It is contemplated that the configuration of the surgical implant system may provide load sharing, dynamic and/or flexible stabilization over a plurality of intervertebral levels, including treated and untreated vertebral and intervertebral levels.
  • In one embodiment, the spinal construct includes an agent, which includes a bone growth promoting material, which may be disposed, packed or layered within, on or about the components and/or surfaces thereof. The bone growth promoting material, such as, for example, bone graft can be a particulate material, which may include an osteoconductive material such as hydroxyapatite and/or an osteoinductive agent such as a bone morphogenic protein (BMP) to enhance bony fixation of spinal construct 100 or 300 with the adjacent vertebrae.
  • In other embodiments, a method for treating a spinal disorder is provided. The method includes implanting a spinal construct comprising a first fastener, a second fastener and a connector. The connector utilized in this method has two ends, a first end including and first expandable member and a second end including a second expandable member. Each expandable member of the connector is engageable with and can be snapped onto the first end of each fastener. After the spinal construct is implanted, the method includes securing the first end of the connector to the first fastener with a first securing member and securing the second end of the connector to the second fastener with a second securing member. In various embodiments, the method provided herein is for treating a spinal disorder, wherein the spinal construct conforms to the curvature of the spine.
  • In some embodiments, the at least two bone screws are implanted into at least one or more vertebrae and the connector is attached to the heads of each bone screw so that the connector pops or snaps on the head of the bone screw. In this way, the connector can easily be applied to the bone screw.
  • 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 (23)

1. A spinal construct comprising:
a first fastener including a first end and a second end configured for penetrating tissue;
a second fastener including a first end and a second end configured for penetrating tissue;
a connector having a first end including a first expandable member and a second end including a second expandable member, the first end of each fastener being engageable with the members to fix the fasteners to the connectors;
a bridge disposed between the members, the bridge being fixed to the members; and
securing members for attaching the connector to the fasteners.
2-3. (canceled)
4. A spinal construct of claim 1, wherein the securing members comprise set screws.
5. A spinal construct of claim 1, wherein the bridge comprises an axis that is perpendicular to the longitudinal axis of the first fastener and/or the second fastener.
6-9. (canceled)
10. A spinal construct of claim 1, wherein the first end of the connector or the second end of the connector or both comprise a C-shape.
11. A spinal construct of claim 1, wherein each expandable member comprises an expansion chamber, each expansion chamber comprising a retaining member and an inner locking ring.
12. A spinal construct of claim 11, wherein the retaining member, the inner locking ring or both are expandable.
13. A spinal construct of claim 11, wherein each expansion chamber further comprises notches configured for receiving the inner locking ring.
14. A spinal construct of claim 11, wherein each retaining member is configured to receive the first end of the first fastener or the second fastener.
15. A spinal construct of claim 11, wherein each retaining member comprises a hexagon, a circle, an ellipse, a rectangle or a square shape.
16. A spinal construct of claim 1, further comprising a marker disposed on the spinal construct for indicating the position of the construct.
17. A spinal construct of claim 1, wherein the first fastener and/or the second fastener comprise a pedicle screw.
18. A spinal construct system comprising:
a first fastener including a first end and a second end configured for penetrating tissue;
a second fastener including a first end and a second end configured for penetrating tissue;
a connector having a first end including a first expandable member and a second end including a second expandable member, the first end of each fastener being engageable with the expandable members to fix the fasteners to the connector;
a bridge disposed between the members, the bridge being fixed to the members; and
a first set screw for securing the first end of the connector to the first fastener and a second set screw for securing the second end of the connector to the second fastener.
19-20. (canceled)
21. A spinal construct of claim 1, wherein the expandable members each include a threaded inner surface and the securing members each include a threaded outer surface configured to engage the threaded inner surfaces.
22. A spinal construct of claim 11, wherein the inner locking ring comprises silicone.
23. A spinal construct of claim 11, wherein the inner locking ring comprises silicone having a hardness from about 40 durameter to about 80 durometer.
24. A spinal construct of claim 11, wherein the expansion chambers each comprise a ledge and a notch configured for receiving the inner locking ring, the expansion chambers each having a uniform diameter between the ledge and the notch.
25. A spinal construct of claim 18, wherein the expandable members each include a threaded inner surface and the set screws each include a threaded outer surface configured to engage the threaded inner surfaces.
26. A spinal construct comprising:
a first fastener including a first end and a second end configured for penetrating tissue;
a second fastener including a first end and a second end configured for penetrating tissue;
a connector having a first member and a second member, the first end of each fastener being engageable with the members to fix the fasteners to the connector, the members each including a chamber defined by an inner wall and a ledge, the first ends of the fasteners being disposed within the chambers, the inner walls each including a notch, the members each including a threaded inner surface defining a hole that extends through the ledge;
a bridge disposed between the members, the bridge being fixed to the members;
a retaining member disposed in each of the chambers such that the first ends of the fasteners engage the retaining members;
a locking ring disposed in each of the notches such that the locking rings surround the first ends of the fasteners; and
securing members each including a threaded outer surface configured to engage the threaded inner surfaces.
27. A spinal construct of claim 26, wherein the ledges extend transverse to the inner walls.
28. A spinal construct of claim 26, wherein the inner walls each include a chamber between the notches and distal ends of the walls, the chambers each including an opening that extends through the distal ends of the walls.
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