Patent Application
20130103153
The present disclosure generally relates to medical devices, systems and methods for the treatment of musculoskeletal disorders, and more particularly to an interbody implant system and method that provides stabilization and height restoration for treating a vertebral column while protecting the structural integrity of vertebral endplates.
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. For example, after a disc collapse, severe pain and discomfort can occur due to the pressure exerted on nerves and the spinal column.
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 fusion, fixation, discectomy, laminectomy and implantable prosthetics. These treatments may employ interbody implants. This disclosure describes an improvement over these prior art technologies.
Accordingly, an interbody implant system and method is provided that provides stabilization and height restoration for treating a vertebral column while protecting the structural integrity of vertebral endplates. It is contemplated that the interbody implant system and method may be employed for an arthrodesis treatment using minimally invasive and percutaneous techniques.
In one embodiment an interbody implant system comprising at least one endplate member defining a longitudinal axis, the endplate member configured for engagement with a vertebral endplate and permanent implantation is provided. The implant system having a permanent implant member having a selected configuration and being disposed adjacent the at least one endplate member within the intervertebral space. The at least one endplate member comprises a first member defining a first longitudinal axis and being engageable with a first vertebral endplate, and a second member defining a second longitudinal axis and engageable with a second opposing vertebral endplate.
In one embodiment, an interbody implant system is provided which includes at least one endplate member defining a longitudinal axis, a trial member and a permanent implant. The endplate member is configured for engagement with a vertebral endplate and permanent implantation. The trial member is configured for disposal adjacent the at least one endplate member within an intervertebral space. The permanent implant member has a configuration and dimension corresponding to the trial member, and is disposed adjacent the at least one endplate member within the intervertebral space.
In another embodiment, the interbody implant system includes a first member, a second member, a trial member and a permanent implant member. The first member is configured for alignment with a first vertebral endplate surface and permanent implantation therewith. The first member defines a longitudinal axis, a first surface engageable with the first vertebral endplate surface and a second surface oriented in an opposing direction. The second surface defines a first keyway. The second member is configured for alignment with a second vertebral endplate surface and permanent implantation therewith. The second member defines a longitudinal axis, a first surface engageable with the second vertebral endplate surface and a second surface oriented in an opposing direction. The second surface of the second member defines a second keyway. The trial member is configured for removable disposal with the first and second members between the first and second vertebral endplate surfaces. The trial member includes a first rail disposable in the first keyway and second rail disposable in the second keyway. The permanent implant member has a configuration and dimension corresponding to the trial member and is disposed with the first and second members between the first and second vertebral endplate surfaces.
In yet another embodiment, a method for treating a spine is provided. The method includes the steps of: (1) providing at least one endplate member; (2) delivering the at least one endplate member into an intervertebral space and into alignment with a vertebral endplate for permanent implantation; (3) providing at least one trial member; (4) delivering the at least one trial member adjacent the at least one endplate member within the intervertebral space; (5) selecting one of the at least one trial member to determine a configuration and dimension of the intervertebral space; (6) providing a permanent implant member based on the selected trial member; and (7) delivering the permanent implant member adjacent the at least one endplate member within the intervertebral space for permanent implantation.
The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:
Like reference numerals indicate similar parts throughout the figures.
The exemplary embodiments of the interbody implant system and related methods of use disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of an interbody implant that provides stabilization and height restoration for treating a vertebral column while protecting the structural integrity of vertebral endplates. It is envisioned that the interbody implant system may be employed for fusion and fixation treatments to provide decompression, restoration of lordosis and resistance of subsidence into tissue, for example, vertebral endplates. It is further envisioned that the interbody implant system and methods of use disclosed can be employed to obtain fusion of vertebrae through a minimally invasive or percutaneous technique. In one embodiment, the disclosed interbody implant system and methods of use can provide improved spinal treatment with two anatomically shaped plates that may be inserted into the disc space between two adjacent vertebrae to protect the vertebral endplates during trialing, in which the proper size and/or shape of an implant to be permanently inserted into the disc space is determined. Once the trialing is complete, a permanent implant member having and the proper size and/or shape is inserted between the anatomical plates to form a final assembled implant. Assembly may occur in situ. It is contemplated that the anatomical plates may be inserted independently, such that each plate is inserted using its own insertion instrument. It is also contemplated that the anatomical plates may be connected to an insertion instrument that couples both plates together. It is further contemplated that the insertion instrument may incorporate a hook to place over a retractor blade(s) to maintain the anatomical plates in place. The hook may include a sliding and locking feature so that the length of the retractor blade(s) may be adjusted. That is the length of the retractor blades determine the placement of the hooks and where the hooks are coupled or locked in place. This feature adjusts the length of the blades.
It is envisioned that 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. It is contemplated that the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. It is further contemplated that the disclosed interbody implant 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, medial, lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic and pelvic regions of a spinal column. The interbody implant system and methods of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.
The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention 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 of the claimed invention. Also, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “superior” and “inferior” are relative and used only in the context to the other, and are not necessarily “upper” and “lower”.
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 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 an interbody implant system and related methods of employing the interbody implant system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference will now be made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning now to
The components of the interbody implant system can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the components of the interbody implant system, individually or collectively, can be fabricated from materials such as stainless steel alloys, commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-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, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations. Various components of the interbody implant system 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 the interbody implant system, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. For example, in one embodiment, the at least one endplate member 30 may be fabricated from titanium or titanium alloy, while the permanent implant member 34 may be fabricated from PEEK and/or PEEK composites.
The interbody implant system includes at least one endplate member 30, a trial member 32 and a permanent implant member 34. Endplate member 30 is anatomically configured for engagement and alignment with a vertebral endplate and permanent implantation thereto. In one embodiment, endplate member 30 includes a first member 36 defining a first longitudinal axis engageable with a first vertebral endplate and a second member 38 defining a second longitudinal axis engageable with a second opposing vertebral endplate. It is envisioned that the first and second longitudinal axes may be the same such that first and second members 36, 38 are aligned with one another. It is also envisioned that the first and second longitudinal axes may be different such that first and second members 36, 38 are disposed at an angle relative to one another.
First member 36 includes a proximal end 40, a distal end 42 opposite proximal end 40, upper and lower surfaces 44, 46, and side surfaces 48, 50. Upper surface 44 is configured to interface with a load bearing endplate of a vertebra and is convexly curved between proximal end 40 and distal end 42 such that the height of first member 36 at a point between proximal end 40 and distal end 42 is greater than the height of first member 36 at proximal end 40 and/or distal end 42. However, it is envisioned that upper surface 44 may also be planar along the length thereof such that upper surface 44 has a uniform height between proximal end 40 and distal end 42. Upper surface 44 may include bone engaging features 45 configured to reduce slipping or movement relative to the endplate of the vertebra upper surface 44 is configured to interface. Lower surface 46 is planar along the length thereof and is configured to interface with a corresponding surface of trial member 32 or permanent implant member 34. First member 36 has a width defined by the distance between side surfaces 48, 50 that is approximately the width of the endplate of the vertebra first member 36 is configured to interface. In some embodiments, the width defined by the distance between the side surfaces 48, 50, is less than the approximate width of the endplate of the vertebra first member 36 is configured o interface. First member 36 has a length defined by the distance between proximal end 40 and distal end 42 which is approximately the length of the endplate of the vertebra first member 36 is configured to interface. First member 36 may include an Opening 47 extending through upper and lower surfaces 44, 46 between side surfaces 48, 50.
Second member 38 has a configuration similar to first member 36 and includes a proximal end 52, a distal end 54 opposite proximal end 52, upper and lower surfaces 56, 58, and side surfaces 60, 62. Upper surface 56 is configured to interface with a load bearing endplate of a vertebra adjacent the endplate of the vertebra upper surface 44 of first member 36 is configured to interface and is convexly curved between proximal end 52 and distal end 52 such that the height of second member 38 at a point between proximal end 52 and distal end 54 is greater than the height of second member 38 at proximal end 52 and/or distal end 54. However, it is envisioned that upper surface 56 may also be planar along the length thereof such that upper surface 56 has a uniform height between proximal end 52 and distal end 54. Upper surface 56 may include bone engaging features 57 configured to reduce slipping or movement relative to the endplate of the vertebra upper surface 56 is configured to interface. Lower surface 58 is planar along the length thereof and is configured to interface with a corresponding surface of trial member 32 or permanent implant member 34. Second member 38 has a width defined by the distance between side surfaces 60, 62 that is approximately the width of the endplate of the vertebra second member 38 is configured to interface. Second member 38 has a length defined by the distance between proximal end 52 and distal end 54, which is approximately the length of the endplate of the vertebra second member 38, is configured to interface. Second member 38 may include an opening (not shown) extending through upper and lower surfaces 56, 58 between side surfaces 60, 62. The opening in second member 38 is configured to align with opening 47 in first member 36 such that the opening in second member 38 is in communication with opening 47.
In one embodiment, first member 36 includes a first locking part, such as, for example, a cavity 64 disposed in proximal end 40 between side surfaces 48, 50. Cavity 64 is disposed equidistant between side surfaces 48, 50. However, it is envisioned that cavity 64 may be disposed closer to side surface 48 than side surface 50, or vice versa. Cavity 64 extends through upper and lower surfaces 44, 46 such that cavity 64 defines an opening in upper and lower surfaces 44, 46 defining a passageway therethrough. However, it is envisioned that cavity 64 may extend through lower surface 46 without extending through upper surface 44. Cavity 64 is configured to receive a corresponding locking part of second member 38 to couple first and second members 36, 38 to one another.
Second member 38 includes a second coupling or locking part, such as, for example, a protrusion 66 disposed in proximal end 52 between side surfaces 60, 62 configured to be received within cavity 64. It is understood that although the term locked is used it includes embodiments where the parts are simply coupled together. Protrusion 66 is positioned equidistant between side surfaces 60, 62. However, it is envisioned that protrusion 66 may be positioned such that protrusion 66 is closer to side surface 60 than side surface 62, or vice versa. Protrusion 66 extends perpendicularly from lower surface 58 of second member 38 a distance such that trial member 32 or permanent implant member 34 may be placed between first and second members 36, 38 when protrusion 66 is received within cavity 64 to couple first and second members 36, 38 to one another. In one embodiment, cavity 64 and protrusion 66 have corresponding cylindrical cross-sections, such that protrusion 66 may be received within cavity 64. However, it is envisioned that cavity 64 and/or protrusion 66 may have other corresponding cross-sectional configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered. In one embodiment, protrusion 66 is moveably disposed in cavity 64 such that first and second members 36, 38 may pivot relative to one another to separate distal ends 42, 54 of first and second members 36, 38 to allow trial member 32 or permanent implant member 34 to be inserted between first and second members 36, 38. For example, protrusion 66 may include a ball at an end thereof configured to be received within a corresponding cavity 64 such that protrusion 66 can rotate within cavity 64. It is envisioned that first member may pivot axially about protrusion 66 relative to second member 38 such that first member 36 may be off-set from second member 38 at an angle. In one embodiment, protrusion 66 is fixed within cavity 64 in a configuration to align first and second members 36, 38. It is envisioned that protrusion 66 and cavity 64 could be positioned on both the first and second members so that both members have a protrusion and a cavity that couples them together.
First and second members 36, 38 are configured to be inserted in between the endplates of adjacent vertebrae to protect the endplates from undesirable engagement of a trial member with a vertebral endplate during trialing, in which various trial members, such as trial member 32, may be inserted between first and second members 36, 38 to determine the proper size and shape of an intervertebral space and hence an intervertebral implant. After the size and shape of the intervertebral space is determined, the trial member may be removed and a permanent implant member having the proper size and shape, such as permanent implant member 34, may be inserted in place of the trial member.
One or more instruments, such as instruments 68, 70, may be used to facilitate insertion of first member 36 and/or second member 38 into an intervertebral space. As discussed above, it is envisioned that first and second members 36, 38 may be inserted into an intervertebral space individually, or coupled to one another. As shown in
Trial member 32 is configured for disposal adjacent endplate member 30 within an intervertebral space to determine the height of the intervertebral space and/or lordotic angle. As best shown in
It is envisioned that the system of the present disclosure may include a plurality of trial members, each having differing heights and angles of lordosis, to determine the geometry of a permanent implant member that should be inserted between first and second members 36, 38. In one embodiment, distal end 78 is configured to engage an instrument, such as instrument 108, to manipulate trial member 32 such that trial member 32 can be inserted and/or removed from a location adjacent first and second members 36, 38 within an intervertebral space. In one embodiment, instrument 108 could be configured so that the trial member 32 is permanently attached to the instrument 108.
Trial member 32 is configured to be inserted between first and second members 36, 38 of endplate member 30. When first and second members 36, 38 are coupled to one another by inserting protrusion 66 of second member 38 into cavity 64 of first member 36, trial member 32 may be inserted between distal ends 42, 54 of first and second members 36, 38 leading with proximal end 76 and is advanced proximally until proximal end 76 engages protrusion 66 of second member 38, which prevents trial member 32 from advancing further.
Permanent implant member 34 has a configuration and dimension corresponding to trial member 32, and is disposed adjacent first and second members 36, 38 of endplate member 30 within an intervertebral space. As best shown in
The height of permanent implant member 34 is approximately the distance between the endplates of the adjacent vertebrae, which define an intervertebral space less the height of first and second members 36, 38. That is, first and second members 36, 38 and permanent implant member 34 combine to occupy the intervertebral space between two adjacent vertebrae. In one embodiment, in which only first member 36 or second member 38 is inserted into an intervertebral space, the height of permanent implant member 34 is approximately the distance between endplates of the adjacent vertebrae which define an intervertebral space less the height of first member 36 or second member 38. Permanent implant member 34 has a width defined by the distance between side surfaces 96, 98 that is approximately the width of first member 36 and/or second member 38. Permanent implant member 34 has a length defined by the distance between proximal end 88 and distal end 90, which is approximately the length of first member 36 and/or second member 38. Permanent implant member may include an opening 93 extending through upper and lower surfaces 92, 94 between side surfaces 96, 98 configured for disposal of a material, such as, for example, a bone growth material. Opening 93 may align with opening 47 in first member 36 and the opening in second member 38 such that all three openings are in communication. That is, the three openings define a passageway through first member 36, permanent implant member 34, and second member 38 such that a material disposed in opening 93 may reach the endplates through opening 47 and/or the opening in second member 38.
In one embodiment, distal end 90 of permanent implant member 34 is configured to engage an instrument to manipulate permanent implant member 34 such that permanent implant member 34 can be inserted and/or removed from a space between first and second members 36, 38, when first and second members 36, 38 are inserted in an intervertebral space. It is envisioned that permanent implant member 34 may include at least one recess 100 disposed in distal end 90 thereof configured to receive at least a portion of an instrument, as shown in
Permanent implant member 34 is configured to be inserted between first and second members 36, 38 of endplate member 30 when first and second members 36, 38 are coupled to one another by inserting protrusion 66 of second member 38 into cavity 64 of first member 36, permanent implant member 34 may be inserted between distal ends 42, 54 of first and second members 36, 38 leading with proximal end 88 and is advanced proximally until proximal end 88 engages protrusion 66 of second member 38, which prevents permanent implant member 34 from advancing further. Permanent implant member 34 may then be positioned by moving permanent implant member 34 relative to first member 36 and/or second member 38 such that permanent implant member 34 is aligned with first member 36 and/or second member 38.
In one embodiment of the system of the present disclosure, a backout prevention member 102 is provided to maintain permanent implant member 34 in position between first and second members 36, 38, while maintaining the position of first member 36 relative to second member 38. Backout prevention member 102 is a tab which extends transversely across distal ends 42, 54, 90 of first member 36, second member 38 and permanent implant member 34 and includes a protrusion 104 configured to be received within recess 72 of first member 36 and a protrusion 106 configured to be received within recess 74 of second member 38. In one embodiment, protrusions 104 are separate screws or pins configured to lock the backout preventer member 102 in place. That is, at least a portion of protrusions 104, 106 are inserted into recesses 72, 74 to lock backout prevention member 102 in place which maintains first and second members 36, 38 in position relative to one another, and prevents permanent implant member 34 from backing out from its location between first and second members 36, 38. It is envisioned that backout prevention member 102 may be used to maintain a trial member, such as trial member 32, in position between first and second members 36, 38, while maintaining the position of first member 36 relative to second member 38.
As discussed above, endplate member 30 is configured to be inserted between the endplates of adjacent vertebrae. Prior to insertion, first and second members 36, 38 of endplate member 30 may be coupled to one another, as shown in
Once endplate member 30 is positioned within the intervertebral space, trial member 32 is then delivered adjacent endplate 30 member within the intervertebral space such that upper surface 80 of trial member 32 interfaces with lower surface 46 of first member 36 and lower surface 82 of trial member 32 interfaces with lower surface 58 of second member 38, as shown in
Permanent implant member 34 having a size and shape which corresponds to that of the selected trial member 32 may then be delivered adjacent endplate member 30 within the intervertebral space for permanent implantation. In particular, permanent implant member 34 is inserted between first and second members 36, 38 after trial member 32 is removed therefrom, as shown in
As discussed above, the system of the present disclosure may include a plurality of trial members, similar to trial member 32, but having differing heights and angles of lordosis, to determine the height of a permanent implant member that should be inserted between first and second members 36, 38. Shown in
In one embodiment, as shown in
In one embodiment, shown in
In one embodiment, first and second rails 281, 283 each extend from distal end 278 of trial member 232 to the proximal 1 end thereof However it is envisioned that first rail 281 may be extend along a portion of upper surface 280 between distal end 278 and the proximal end of trial member 232. Likewise, second rail 283 may extend along a portion of lower surface 282 between distal end 278 and the proximal end of trial member 232. In one embodiment, first and second rails 281, 283 each have a planar top portion between arcuate side surfaces. First and second rails 281, 283 each taper from the top portion of each rail to the surface of trial member 232 from which each rail extends such that the top portions of first and second rails 281, 283 each have a width which is greater than the width of first and second rails 281, 283 adjacent the surface of trial member 232 from which they extend. That is, first and second rails 281, 283 each have a T-shaped cross-section. However, it is envisioned that first and second rails 281, 283 may have cross-sections corresponding the size and shape of the keyways in first and second members 136, 138, including, for example, L-shaped, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered. In one embodiment, first and second rails 281, 283 are offset. That is, first rail 281 is disposed closer to side surface 286 than side surface 284 and second rail 283 is disposed closer to side surface 284 than side surface 286. However, it is envisioned that first rail 281 may be disposed closer to side surface 284 than side surface 286 and second rail 283 may be disposed closer to side surface 286 than side surface 284. Alternatively, first and second rails 281, 283 may be equidistant from side surfaces 284, 286.
First member 136 includes a first keyway 147 configured to receive first rail 281 and second member 138 includes a second keyway 159 configured to receive second rail 283. First and second keyways 147, 159 have cross-sections corresponding to the size and shape of first and second rails 281, 283, including, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered. Since the trial is used to determine the size of the implant that needs to go between the endplate members the keyways and rails do not necessarily need to perfectly match each other. In one embodiment, the endplate members can be lifted off the trial without the rails interfering. The rails are provided fir side-to-side positioning so as to facilitate easy permanent implant insertion. In one embodiment, first and second keyways 147, 149 have a diameter at the top of each keyway which is greater than the diameter at bottom of each keyway, the top of each keyway having a diameter at the top of each keyway which is greater than the diameter of the top portions of first and second rails 281, 283 and a diameter at the bottom of each keyway that is less than the diameter of the top portions of first and second rails 281, 283 such that the top portions of first and second rails 281, 283 are prevented from falling through the bottom of each keyway. First keyway 147 extends along the length of first member 136 through lower surface 146 of first member 136 without extending through upper surface 144. Second keyway 159 extends along the length of second member 138 through lower surface 158 of second member 138 without extending through upper surface 156.
First and second keyways 147, 159 are offset such that the position of first keyway 147 corresponds to the position of first rail 281 and the position of second keyway 159 corresponds to the position of second rail 283 when first and second members 136, 138 are aligned with trial member 232. That is, first and second members 136, 138 and trial member 232 are configured such that first rail 281 is received within first keyway 147 and second rail 283 is received within second keyway 159 when first and second members 136, 138 are aligned with trial member 232. In particular, trial member 232 is inserted between the distal ends 142 & 154 of first and second members 136, 138 leading with the proximal end 276 such that first rail 281 is received within first keyway 147 and second rail 283 is received within second keyway 159. Trial member 232 is then advanced toward proximal ends 140, 152 with first and second members 136, 138 aligned with trial member 232.
In one embodiment, shown in
In one embodiment, first and second rails 293, 295 each extend from distal end 290 of permanent implant member 234 to the proximal end thereof However it is envisioned that first rail 293 may be extend along a portion of upper surface 292 between distal end 290 and the proximal end of permanent implant member 234. Likewise, second rail 295 may extend along a portion of lower surface 294 between distal end 290 and the proximal end of permanent implant member 234. In one embodiment, first and second rails 293, 295 each have a planar top portion between arcuate side surfaces. First and second rails 293, 295 each taper from the top portion of each rail to the surface of permanent implant member 234 from which each rail extends such that the top portions of first and second rails 293, 295 each have a width which is greater than the width of first and second rails 293, 295 adjacent the surface of permanent implant member 234 from which they extend. That is, first and second rails 293, 295 each have a T-shaped cross-section or dovetail cross-section. However, it is envisioned that first and second rails 293, 295 may have cross-sections corresponding the size and shape of the keyways in first and second members 136, 138, including, for example, L-shaped, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable and/or tapered.
In one embodiment, first and second rails 293, 295 are offset. That is, first rail 293 is disposed closer to side surface 298 than side surface 296 and second rail 295 is disposed closer to side surface 296 than side surface 298. However, it is envisioned that first rail 293 may be disposed closer to side surface 296 than side surface 298 and second rail 295 may be disposed closer to side surface 298 than side surface 296. Alternatively, first and second rails 293, 295 may each be equidistant from side surfaces 296, 298. Permanent implant member 234 is inserted between the distal ends 142, 154 of first and second members 136, 138 leading with the proximal end 288 such that first rail 293 is received within first keyway 147 and second rail 295 is received within second keyway 159. Permanent implant member 234 is then advanced toward proximal ends 140, 152 with first and second members 136, 138 aligned with permanent member 234.
In one embodiment, shown in
In one embodiment, shown in
In one embodiment, shown in
Second member 438 includes rail 481 extending perpendicularly therefrom configured to be disposed in second keyway 495. Rail 481has a cross-sectional configuration corresponding the size and shape of second keyway 495. It is envisioned that first member 436 may include a rail 497 extending perpendicularly therefrom configured to be disposed in first keyway 493. Accordingly, rails may extend from a trial member, as shown in
In assembly, operation and use, the interbody implant system is employed with a surgical procedure such as a fusion treatment of a spine of a patient including vertebrae, intervertebral disc space, as discussed herein. The interbody implant system may also be employed with other surgical procedures, such as, for example, discectomy, laminotomy, laminectomy, nerve root retraction, foramenotomy, facetectomy, decompression, and spinal, nucleus or disc replacement.
For example, the interbody implant system can be employed with a surgical procedure to provide height restoration between vertebral bodies for treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body, such as, for example, intervertebral disc space between the endplates of adjacent vertebrae. It is contemplated that the interbody implant system can be inserted within an intervertebral space-to-space apart articular joint surfaces, provide support and maximize stabilization of the vertebrae.
It is envisioned that the interbody implant system can be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby vertebrae are accessed through 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 is performed for treating the spine disorder. The interbody implant system is then employed to augment the surgical treatment. It is contemplated that one or all of the components of the interbody implant system can be delivered to the surgical site via manual manipulation and/or a free hand technique. It is further contemplated that the components of the interbody implant system may be inserted posteriorly, and then manipulated anteriorly and/or lateral and/or medial.
It is envisioned that the components of the interbody implant system can be delivered to the surgical site via alternate approaches, such as, for example, delivery through the surgical pathway along a direct lateral approach, a transforaminal lumbar interbody fusion approach and a posterior lumbar interbody fusion.
In one embodiment, the interbody implant system includes at least one agent, which may be disposed, packed or layered within, on or about the components and/or surfaces thereof. For example, at least one agent may be configured for disposal within endplate member 30 and/or permanent implant member 34. The at least one agent can include bone growth promoting material, such as, for example, a bone graft. The 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 endplate member 30 with the endplates of adjacent vertebrae.
It is contemplated that the bone graft may include therapeutic polynucleotides or polypeptides. It is further contemplated that the bone graft may include biocompatible materials, such as, for example, biocompatible metals and/or rigid polymers, such as, titanium elements, metal powders of titanium or titanium compositions, sterile bone materials, such as allograft or xenograft materials, synthetic bone materials such as coral and calcium compositions, such as hydroxyapatite, calcium phosphate and calcium sulfite, biologically active agents, for example, gradual release compositions such as by blending in a bioresorbable polymer that releases the biologically active agent or agents in an appropriate time dependent fashion as the polymer degrades within the patient. Suitable biologically active agents include, for example, BMP, Growth and Differentiation Factors proteins (GDF) and cytokines.
It is envisioned that the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration. The agents may include pharmacological agents, such as, for example, antibiotics, anti-inflammatory drugs including but not limited to steroids, anti-viral and anti-retroviral compounds, therapeutic proteins or peptides, therapeutic nucleic acids (as naked plasmid or a component of an integrating or non-integrating gene therapy vector system), and combinations thereof.
The agent may also include analgesics or anesthetics such as acetic acid derivatives, COX-2 selective inhibitors, COX-2 inhibitors, enolic acid derivatives, propionic acid derivatives, salicylic acid derivatives, opioids, opioid/nonopioid combination products, adjuvant analgesics, and general and regional/local anesthetics.
The agent may also include antibiotics such as, for example, amoxicillin, beta-lactamases, aminoglycosides, beta-lactam (glycopeptide), clindamycin, chloramphenicol, cephalosporins, ciprofloxacin, erythromycin, fluoroquinolones, macrolides, metronidazole, periicillins, quinolones, rapamycin, rifampin, streptomycin, sulfonamide, tetracyclines, trimethoprim, trimethoprim-sulfamthoxazole, and vancomycin.
The agent may also include immunosuppressives agents, such as, for example, steroids, cyclosporine, cyclosporine analogs, cyclophosphamide, methylprednisone, prednisone, azathioprine, FK-506, 15-deoxyspergualin, prednisolone, methotrexate, thalidomide, methoxsalen, rapamycin, leflunomide, mizoribine (bredinin™), brequinar, deoxyspergualin, and azaspirane (SKF 105685), Orthoclone OKT™ 3 (muromonab-CD3). Sandimmune™, Neoral™, Sangdya™ (cyclosporine), Prograf™ (FK506, tacrolimus), Cellcept™ (mycophenolate motefil, of which the active metabolite is mycophenolic acid), Imuran™ (azathioprine), glucocorticosteroids, adrenocortical steroids such as Deltasone™ (prednisone) and Hydeltrasol™ (prednisolone), Folex™ and Mexate™ (methotrxate), Oxsoralen-Ultra™ (methoxsalen) and Rapamuen™ (sirolimus).
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.
