The repair and reconstruction of bony structures is sometimes accomplished by fixing adjacent bony structures relative to one another, such as by a plate. In other instances, bone growth inducing material can be introduced between the adjacent bony structures, which over time results in a solid bony connection. In some instances, the adjacent bony structures are not sufficiently strong to maintain their patency as the bone heals or the bone grows between the adjacent structures through the bone growth inducing material. In these instances, mesh structures or cages have been provided to engage the adjacent bony structures to provide additional stability. The cages are generally hollow and can be configured to contact the harder cortical bone of the adjacent bony structures. The hollow portion of the cages can be filled with bone growth inducing material.
Devices have been positioned in a disc space between adjacent vertebrae to provide support while the adjacent vertebrae are fused to one another. Devices have also been provided to replace a removed vertebral body and to provide a support structure between the remaining vertebrae on either side of the one or more removed vertebral bodies. However, there remains a need for improved devices for replacing one or more vertebral bodies and/or to provide support of adjacent vertebrae with one or more devices in a disc space between adjacent vertebrae. The present invention is directed to satisfying these needs, among others.
There are provided devices for replacement of one or more vertebral bodies to support the remaining vertebrae. Also provided are one or more devices that support adjacent vertebrae in the disc space between the adjacent vertebrae.
According to one aspect, a spinal interbody fusion member comprises a body including an anterior side, a posterior side, and a pair of opposite sides extending between the anterior and posterior sides. The body also defines a superior bearing surface and an opposite inferior bearing surface. The superior bearing surface includes a convexly curved profile between the anterior and posterior sides and the inferior bearing surface includes a planar profile between the anterior and posterior sides.
According to another aspect, a spinal interbody fusion member comprises a body including an anterior wall, a posterior wall, and a pair of opposite sidewalls extending between the anterior and posterior walls. The walls define a superior bearing surface and an opposite inferior bearing surface and a chamber opening through the superior and inferior bearing surfaces. The superior bearing surface includes a convexly curved profile between the anterior and posterior walls and the inferior bearing surface includes a planar profile between the anterior and posterior walls. The inferior and superior bearing surfaces taper toward a leading end nose at a posterior side of the posterior wall.
According to another aspect, a vertebral body replacement device comprises a connecting member including a body extending along a longitudinal axis between a superior end and an opposite inferior end. The connecting member includes an upper extension extending from the superior end and a lower extension extending from the inferior end. The superior end further includes at least one planar surface section extending about the upper extension and the inferior end includes a concavely curved surface extending about the lower extension. The replacement device further includes upper and lower disc replacement members removably attached to the connecting body about respective ones of the upper and lower extensions. The upper disc replacement member includes a superior bearing surface for contacting an endplate of an adjacent vertebra and an opposite inferior bearing surface including at least one planar profile positioned in abutting engagement with the at least one planar surface section of the superior end of the connecting body. The lower disc replacement member includes an inferior bearing surface for contacting an endplate of an adjacent vertebra and an opposite superior bearing surface including a convexly curved profile positioned in abutting engagement with the concavely curved surface of the inferior end of the connecting body.
According to a further aspect, a vertebral body replacement device comprises a connecting member including a body extending along a longitudinal axis between a superior end and an opposite inferior end. The connecting member includes an upper extension extending from the superior end and a lower extension extending from the inferior end. The vertebral replacement device further comprises upper and lower disc replacement members removably attached to the connecting body about respective ones of the upper and lower extensions. The upper disc replacement member includes a superior bearing surface for contacting an endplate of an upper vertebra with the superior bearing surface including a convexly curved profile between anterior and posterior sides of the upper disc replacement member. The lower disc replacement member includes an inferior bearing surface for contacting an endplate of a lower vertebra with the inferior bearing surface including at least one planar profile extending over a substantial portion of the inferior bearing surface from an anterior side of the lower disc replacement member toward a posterior side of the lower disc replacement member.
According to another aspect, a method for supporting vertebrae of a spinal column comprises: accessing a space between the vertebrae from an anterior approach; and supporting the vertebrae with an interbody device between the vertebrae, wherein the interbody device includes a superior bearing surface contacting an endplate of one of the vertebrae with a convexly curved profile between anterior and posterior sides of the interbody device, the interbody device further including an inferior surface contacting an endplate of the other of the vertebrae with at least one planar profile extending along a substantial portion of the inferior surface from the anterior side toward the posterior side of the interbody device.
These and other aspects will be discussed further below.
For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the illustrated embodiments thereof and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any such alterations and further modifications in the invention, and any such further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
The disclosed embodiments relate to devices for replacing one or more vertebral bodies in the spinal column and/or one or more disc spaces between adjacent vertebrae. It is contemplated that the replacement devices will support vertebrae during fusion thereof. It is further contemplated that one or more components of the vertebral replacement devices are positionable in a disc space between adjacent vertebrae for supporting the adjacent vertebrae during fusion thereof. Applications in non-fusion procedures are also contemplated
The device is configured to engage the endplates of the vertebrae at opposite ends of the device. In one embodiment, the device has a tubular form with a hollow chamber extending therethrough and opening at each end. The vertebrae are supported by the device while the chamber contains bone growth inducing or osteogenetic material. The ends of the device include engaging members that engage the adjacent vertebral endplate. In a further embodiment, one of the ends of the device includes a convexly curved configuration while the other of the ends of the device includes a planar configuration.
In one embodiment, the device is a vertebral replacement device that includes a connecting member and an upper member attached to an upper end of the connecting member and a lower member attached to a lower end of the connecting member. The upper and lower members each have opposite end surfaces. The end surfaces of a respective upper or lower member have different configurations from one another. In one embodiment, one of the end surfaces has a convexly curved configuration and the opposite end surface has a planar configuration. The ends of the connecting member also include different configurations to accept respective ones of the curved and planar end surface configurations of the adjacent upper and lower member attached thereto.
Each of the upper and lower members and the connecting member has the same cross-sectional shape in the plane transverse to the central axis of the assembled device. In one embodiment, the shape is defined by a convexly curved anterior wall, a linear posterior wall, and opposite sidewalls that converge toward one another toward the posterior wall. Other cross-sectional shapes are also contemplated, including circular, racetrack-shaped, rectangular, square, oval, D-shaped, triangular, boomerang, kidney, or other polygonal shape. Each of the upper and lower members includes an interior chamber surrounded by the walls thereof. The connecting member can also include an interior chamber that generally aligns with the interior chambers of the upper and lower members when engaged thereto. Other embodiments contemplate one or more sides of the upper member, lower member or connecting member are open into the chamber.
In one embodiment, the upper and lower members are telescopically and non-rotatably engaged with the respective end of the connecting member. The connecting member includes an upper extension and a lower extension extending therefrom. The upper and lower extensions are in the form of substantially continuous rings extending around the respective ends of the connecting member. The upper and lower members are positioned about the respective adjacent extension and axially secured thereto with an engaging member extending between the extension and the upper or lower member positioned thereabout. In another embodiment, extensions are provided on the upper and lower members, and these extensions are received in an interior chamber or opening at respective ends of the connecting member. Each of the upper and lower extensions, and each of the chambers of the upper and lower members, has a non-circular cross-section and interface to prevent relative rotation between the connecting member and the upper or lower member positioned about the extension. In one embodiment, the upper and lower extensions of the connecting member each include an engaging member which fits into a receptacle in the inner wall surface of the respective upper and lower members to axially secure the respective upper and lower members to the connecting member.
Any one or all of the components of the vertebral replacement devices can be made from any biocompatible material, including synthetic or natural autograft, allograft or xenograft tissues, and can be resorbable or non-resorbable in nature. Examples of tissue materials include hard tissues, connective tissues, demineralized bone matrix and combinations thereof. Further examples of resorbable materials are polylactide, polyglycolide, tyrosine-derived polycarbonate, polyanhydride, polyorthoester, polyphosphazene, calcium phosphate, hydroxyapatite, bioactive glass, and combinations thereof. Further examples of non-resorbable materials are non-reinforced polymers, carbon-reinforced polymer composites, PEEK and PEEK composites, shape-memory alloys, titanium, titanium alloys, cobalt chrome alloys, stainless steel, ceramics and combinations thereof and others as well.
Any suitable osteogenetic material or composition is contemplated for placement within the chambers defined by the components or the vertebral replacement device. Such osteogenic material includes, for example, autograft, allograft, xenograft, demineralized bone, synthetic and natural bone graft substitutes, such as bioceramics and polymers, and osteoinductive factors. Where bony material is placed within the chambers of the components of the vertebral replacement device, the material can be pre-packed into the hollow chambers before the device is implanted, or can be pushed through the plurality of wall openings after the device is in position in the spinal column. A separate carrier to hold the materials within the chambers of the device can also be used. These carriers can include collagen-based carriers, bioceramic materials, such as BIOGLASS®, hydroxyapatite and calcium phosphate compositions. The carrier material can be provided in the form of a sponge, a block, folded sheet, putty, paste, graft material or other suitable form. Moreover, the osteogenetic compositions contained within the vertebral replacement device can comprise an effective amount of a bone morphogenetic protein, transforming growth factor β1, insulin-like growth factor 1, platelet-derived growth factor, fibroblast growth factor, LIM mineralization protein (LMP), and combinations thereof or other therapeutic or infection resistant agent, held within a suitable carrier material.
In
Vertebral replacement device 10 is illustrated with a tubular form that extends along a longitudinal axis 11 and defines a chamber 13 extending therethrough along axis 11. Bone growth can occur through this chamber for fusion between the vertebral bodies supported at each end of device 10. Connecting member 12 includes a body 14 extending between an upper end 16 and an opposite lower end 18. Upper member 30a is positioned with its inferior surface in abutting engagement with upper end 16, and lower member 30b is positioned with its superior surface in abutting engagement with lower end 18. Upper end 16 includes a planar arrangement to provide an intimate fit with the planar inferior surface profile of upper member 30. Lower end 18 includes a concavely curved arrangement to provide an intimate fit with the convexly curved superior surface profile of lower member 30b.
The wall of body 14 and the walls of upper and lower members 30 are shown solid. Other embodiments contemplate the walls of any one or combination of the members 12, 30 may include one or more apertures in communication with the interior chamber thereof. Various shapes for the apertures are also contemplated, including non-circular shapes such as a square, diamond, triangular, oval and/or rectangular shapes, circular shapes, and/or polygonal shapes. The wall of any one or combination of the members 12, 30 can also include a number of holes extending at least partially therethrough. The holes can be threaded or otherwise sized and/or configured for engagement with one or more insertion instruments (not shown.)
Referring further to
Walls 44, 46, 48 and 50 define superior surface 32 of member 30 and inferior surface 34 of member 30. Superior and inferior surfaces 32, 34 provide bearing surface areas that contact the adjacent vertebral endplate when used as a disc replacement member or the adjacent endplate and the end of connecting member 12 when used in vertebral replacement device 10. Surfaces 32, 34 include a number of recesses extending thereacross to form elongated engaging members 36, 38 extending between sidewalls 48, 50 that are interrupted by central chamber 42 opening through superior and inferior surfaces 32, 34. Anterior wall 44 includes a hole 52 to receive an inserter instrument. Hole 52 can be threaded or in any other suitable configuration for engaging an inserter instrument.
In the illustrated embodiment, member 30 includes radiographic markers that are visible via a suitable surgical imaging system to determine the implanted location and orientation of body 40 without exposing the spinal column laterally. As shown in
Referring to
As shown in
In the illustrated embodiment, superior surface 32 and inferior surface 34 are generally linear in the direction between sidewalls 48, 50 so that opposite sides of body 40 have the same height when viewed in any section parallel to posterior wall 46. The height of body 40 tapers generally toward posterior wall 46 to provide a wedge-shaped profile in the anterior-posterior direction. Planar section 60a of inferior surface 34 extends along a substantial portion of the length L5. In the illustrated embodiment, planar section 60a extends along more than half of the length L5. The convexly curved profile of superior surface 32 extends along substantially the entire length L5.
Body 40 defines an overall maximum height H1 between the outermost ends of engaging members 36, 38. Maximum height H1 ranges from about 5 millimeters to about 14 millimeters, although maximum heights less than 5 millimeters and greater than 14 millimeters are also contemplated based on the anatomy. Body 40 also includes an anterior end wall height H2 at the outer surface of anterior wall 44. Height H2 is about one millimeter less than height H1 since the anterior-most engaging member 36a includes a truncated outermost end in the illustrated embodiment. Anterior endwall height H2 also ranges from about 5 millimeters to about 14 millimeters, but can also be less than 5 millimeters or greater than 14 millimeters depending on the spinal anatomy. Body 40 also includes a posterior height H3 between superior location 66 and inferior location 68. Posterior nose 62 is formed by tapering surfaces located between locations 66, 68 and taper to the posterior-most side of posterior wall 46, as discussed further below. Height H3 corresponds to the height between superior and inferior surfaces 32, 34 at the locations 66, 68. Posterior height H3 is about 1.4 millimeters less than height H1 in one specific embodiment, and can range from about 4 millimeters to about 13 millimeters, but can also be less than 4 millimeters or greater than 13 millimeters depending on the spinal anatomy.
The taper location 68 for inferior surface 34 is located a distance L1 from the posterior-most side of nose 62. Distance L1 is about 3.5 millimeters in one embodiment. Taper angle A1 extends from this taper location 68 to the posterior-most surface of posterior wall 46. The location 66 adjacent superior surface 32 is at the location where superior taper angle A2 intersects a superior extension of the posterior-most surface of posterior wall 46. Taper angle A2 extends from the intersection of anterior-most engaging member 36a and the anterior-most surface of anterior wall 44 toward posterior wall 46. Taper angle A2 is measured from a central axis 64 that is parallel to planar section 60a of inferior surface 34 and orthogonal to the anterior-most surface of anterior wall 44. In one embodiment taper angle A2 is between about 4 to 5 degrees. Other embodiments contemplate other taper angles A2.
Nose 62 includes a height measured at the posterior-most surface of posterior wall 46. The nose height corresponds to posterior height H3 less the inferior taper height H4 of section 60b of inferior surface 34, and also less the superior taper height between superior location 66 and posterior-most surface of posterior wall 46. In one embodiment, inferior taper height H4 is about 2 millimeters, and the superior taper height is formed by a superior taper surface extends at an angle A1 from the posterior-most engaging member 36b the posterior-most side of nose 62. Accordingly, nose 62 is formed by superior and inferior surfaces that converge posteriorly at angle A1 to the posterior-most surface of posterior wall 46.
Referring now
Referring now
Connecting member 12 further includes an upper extension 114 extending from upper end 100 and a lower extension 116 extending from lower end 102. Upper and lower extensions 114, 116 include an outer perimeter that matches the shape of interior chamber 42 so that inner wall surface 84 resides in close or intimate relationship with the respective upper and lower extensions 114, 116. Connecting member 12 further defines an axially extending central chamber 112 that extends through upper and lower ends 100, 102 and also through upper and lower extensions 114, 116. In the illustrated embodiment, chamber 112 includes an oval shape that is elongated in the direction between sidewalls 108, 110 as shown in
As shown in
As shown in
Connecting member 12 is employed with disc replacement members 30 attached at each end thereof for vertebral body replacement procedures. Bearing surfaces 120, 124 extend completely around the respective extensions 114, 116 to provide bearing support of the disc replacement members 30. Connecting member 12 can be provided with various heights between upper and lower ends depending on the number and size of the vertebrae to be replaced. Heights H6 ranging from about 5 millimeters to about 62 millimeters or more are contemplated. In one form, a set of connecting members 12 of various heights are provided in a kit along with a set of disc replacement members 30 of various heights. The connecting member and disc replacement members providing the desired overall height are selected and assembled to form a vertebral replacement device 10.
Furthermore, when device 10 is employed in vertebral body replacement procedures, the endplates of the vertebrae to be supported may not extend parallel to one another but rather are angled to diverge from another in the anterior direction. Connecting member 12 is provided with various angular orientations between upper and lower ends 100, 102 and the outer ends 128, 130 of the upper and lower extensions 114, 116. For example, upper and lower ends 100, 102 can be formed with an angle A6 between planar section 124a and the axis 132 extending between the anterior and posterior sides of bearing surface 120 at lower end 102. Angle A7 is defined between axis 132 and a central axis 134 that extends orthogonally to the central longitudinal axis 11. Angle A8 is defined between axis 134 and outer end 128. Outer end 130 and axis 134 also define an angle A8 therebetween.
In one application, the angulation at the ends of connecting member 12 provides an attachment arrangement to permit superior and inferior ends of the disc replacement devices 30 attached to the respective ends of connecting member 12 to converge posteriorly (diverge anteriorly) to better fit with the endplates of the vertebrae remaining to be supported. The shorter the span between vertebrae, the less angulation is provided between the disc replacement members 30. In one embodiment, where height H6 is small and about 5 millimeters, angle A6 is between about 1 and 2 degrees, angle A7 is between about 1 to 2 degrees, and angle A8 is about 3 degrees. In another embodiment where height H6 is large and about 62 millimeters, angle A6 is between about 19 to 20 degrees, angle A7 is between about 7 to 8 degrees, and angle A8 is about 12 degrees. Other lengths contemplate other angular arrangements between ends 128, 130 and other portions of the connecting body 12 to provide the desired fit with the spinal column anatomy. For example, ends 128, 130 extend parallel to one another in one embodiment. In another embodiment, ends 128, 130 are angled to converge anteriorly and diverge posteriorly.
Vertebral replacement device 10 can be used to replace a vertebra that has been removed from the spinal column segment using known techniques. Device 10 is assembled by securing upper member 30a to upper end 100 of connecting member 12 and securing lower member 30b to the lower end 102 of connecting member 12. This provides a vertebral replacement device 10 that has an overall anterior height that is equal to the sum of the height H6 of body 14 and the height of members heights H2 upper and lower members 30a, 30b.
Although not required, it is contemplated that height H6 is representative of that of the removed vertebra or vertebrae and heights H2 are representative of the heights of the respective disc spaces between the removed vertebrae and the remaining vertebrae V1, V3. Although not shown, it is also contemplate that a stabilization construct may be engaged to and extending between vertebrae V1, V3 or vertebrae V1, V2 along the exterior surfaces thereof outside the space between the vertebrae to provide additional support and stabilize the spinal column segment before, during and, if the construct is non-resorbable and left in the patient, after fusion. The stabilization construct can be a rod system, plate system or artificial ligament system. It is further contemplated that stabilization construct could be attached to any portion of the vertebrae, including the anterior, antero-lateral, lateral, postero-lateral or posterior portions.
It is also contemplated that connecting member 12 could be provided with one end configured to bear against a vertebral endplate, and that only one of the upper and lower members 30a, 30b is engaged to the other end of connecting member 12. The assembled device could then be placed between adjacent vertebrae with an end of connecting member 12 and an end of the selected upper or lower member 30a, 30b in contact with the adjacent vertebral endplates.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the invention are desired to be protected.