Intervertebral implant

Description

BACKGROUND
Field of the Invention

The present invention relates to medical devices and, more particularly, to an intervertebral implant.

Description of the Related Art

The human spine is a flexible weight bearing column formed from a plurality of bones called vertebrae. There are thirty three vertebrae, which can be grouped into one of five regions (cervical, thoracic, lumbar, sacral, and coccygeal). Moving down the spine, there are generally seven cervical vertebra, twelve thoracic vertebra, five lumbar vertebra, five sacral vertebra, and four coccygeal vertebra. The vertebra of the cervical, thoracic, and lumbar regions of the spine are typically separate throughout the life of an individual. In contrast, the vertebra of the sacral and coccygeal regions in an adult are fused to form two bones, the five sacral vertebra which form the sacrum and the four coccygeal vertebra which form the coccyx.

In general, each vertebra contains an anterior, solid segment or body and a posterior segment or arch. The arch is generally formed of two pedicles and two laminae, supporting seven processes—four articular, two transverse, and one spinous. There are exceptions to these general characteristics of a vertebra. For example, the first cervical vertebra (atlas vertebra) has neither a body nor spinous process. In addition, the second cervical vertebra (axis vertebra) has an odontoid process, which is a strong, prominent process, shaped like a tooth, rising perpendicularly from the upper surface of the body of the axis vertebra. Further details regarding the construction of the spine may be found in such common references as Gray's Anatomy, Crown Publishers, Inc., 1977, pp. 33-54, which is herein incorporated by reference.

The human vertebrae and associated connective elements are subjected to a variety of diseases and conditions which cause pain and disability. Among these diseases and conditions are spondylosis, spondylolisthesis, vertebral instability, spinal stenosis and degenerated, herniated, or degenerated and herniated intervertebral discs. Additionally, the vertebrae and associated connective elements are subject to injuries, including fractures and torn ligaments and surgical manipulations, including laminectomies.

The pain and disability related to the diseases and conditions often result from the displacement of all or part of a vertebra from the remainder of the vertebral column. Over the past two decades, a variety of methods have been developed to restore the displaced vertebra to their normal position and to fix them within the vertebral column. Spinal fusion is one such method. In spinal fusion, one or more of the vertebra of the spine are united together (“fused”) so that motion no longer occurs between them. Thus, spinal fusion is the process by which the damaged disc is replaced and the spacing between the vertebrae is restored, thereby eliminating the instability and removing the pressure on neurological elements that cause pain.

Spinal fusion can be accomplished by providing an intervertebral implant between adjacent vertebrae to recreate the natural intervertebral spacing between adjacent vertebrae. Once the implant is inserted into the intervertebral space, osteogenic substances, such as autogenous bone graft or bone allograft, can be strategically implanted adjacent the implant to prompt bone ingrowth in the intervertebral space. The bone ingrowth promotes long-term fixation of the adjacent vertebrae. Various posterior fixation devices (e.g., fixation rods, screws etc.) can also be utilize to provide additional stabilization during the fusion process.

Recently, intervertebral implants have been developed that allow the surgeon to adjust the height of the intervertebral implant. This provides an ability to intra-operatively tailor the intervertebral implant height to match the natural spacing between the vertebrae. This reduces the number of sizes that the hospital must keep on hand to match the variable anatomy of the patients.

In many of these adjustable intervertebral implants, the height of the intervertebral implant is adjusted by expanding an actuation mechanism through rotation of a member of the actuation mechanism. In some intervertebral implants, the actuation mechanism is a screw or threaded portion that is rotated in order to cause opposing plates of the implant to move apart. In other implants, the actuation mechanism is a helical body that is counter-rotated to cause the body to increase in diameter and expand thereby.

Furthermore, notwithstanding the variety of efforts in the prior art described above, these intervertebral implants and techniques are associated with another disadvantage. In particular, these techniques typically involve an open surgical procedure, which results higher cost, lengthy in-patient hospital stays and the pain associated with open procedures.

Therefore, there remains a need in the art for an improved intervertebral implant. Preferably, the implant is implantable through a minimally invasive procedure. Further, such devices are preferably easy to implant and deploy in such a narrow space and opening while providing adjustability and responsiveness to the clinician.

SUMMARY OF THE INVENTION

Accordingly, one embodiment of the present invention comprises a spinal fusion intervertebral implant that includes upper and lower body portions and an actuator shaft that can be sized and configured to be received therebetween. The upper and lower body portions can each have proximal surfaces disposed at proximal ends thereof. The actuator shaft can comprise an inner member and an outer sleeve member adapted to be translatable relative to the inner member. The inner member can have distal and proximal ends and at least one retention structure disposed therebetween. The outer sleeve member can have a proximal end and at least one complementary retention structure being sized and configured to engage the retention structure of the inner member to facilitate selective relative movement of the proximal end of the outer sleeve member toward the distal end of the inner member without rotation.

Further, the intervertebral implant can also include at least one proximal wedge member which can be disposed at the proximal end of the outer sleeve member. The proximal protrusion can be sized and configured to contact the proximal surfaces of the upper and lower body portions upon selective relative movement of the proximal end of the outer sleeve member toward the distal end of the inner member. The longitudinal movement of the proximal wedge member against the proximal surfaces can cause the separation of the upper and lower body portions.

In accordance with another embodiment, a spinal fusion intervertebral implant is provided that comprises upper and lower body portions each having proximal and distal surfaces at proximal and distal ends thereof. The proximal and distal surfaces of the upper and lower body portions can be configured to generally face each other. The implant can further comprise an actuator shaft received between the upper and lower body portions. The actuator shaft can comprise an inner member and an outer sleeve member selectively moveable relative to the inner member. The implant can further comprise a distal wedge member disposed at a distal end of the inner member. The distal wedge member can have an engagement surface configured to provide ratchet-type engagement with the distal surfaces of the upper and lower body portions upon selective relative movement of the distal end of the inner member toward the proximal end of the outer sleeve member. Further, the implant can comprise a proximal wedge member disposed at a proximal end of the outer sleeve member. The proximal wedge member can have an engagement surface configured to provide ratchet-type engagement with the proximal surfaces of the upper and lower body portions upon selective relative movement of the proximal end of the outer sleeve member toward the distal end of the inner member. In such an embodiment, longitudinal movement of the distal wedge member against the distal surfaces and the longitudinal movement of the proximal wedge member against the proximal surfaces can cause separation of the upper and lower body portions. Furthermore, the ratchet-type engagement between the distal and proximal wedge members and the respective ones of the proximal and distal surfaces of the upper and lower body portions can maintain separation of the upper and lower body portions.

In accordance with yet another embodiment, a method of implanting a implant is also provided. The method can comprise the steps of positioning the implant between two vertebral bodies and moving an inner member of an actuator shaft of the implant in an proximal direction relative to an outer sleeve member disposed about the inner sleeve member to force a proximal protrusion of the outer sleeve member against proximal surfaces of respective ones of upper and lower body portions of the implant to separate the upper and lower body portions to cause the implant to expand intermediate the vertebral bodies.

In accordance with yet another embodiment, a method of implanting a implant is also provided. The method can comprise the steps of positioning the implant between two vertebral bodies and rotating a screw mechanism of the implant to cause proximal and distal wedge members to converge toward each other and engage respective ones of proximal and distal surfaces of upper and lower body portions of the implant to separate the upper and lower body portions to cause the implant to expand.

In accordance with yet another embodiment, an adjustable spinal fusion intervertebral implant is provided that comprises upper and lower body portions, proximal and distal wedge members, and a pin.

The upper and lower body portions can each have proximal and distal surfaces at proximal and distal ends thereof. The proximal and distal surfaces of the upper and lower body portions can generally face each other. The proximal surfaces of the respective ones of the upper and lower body portions can each define a proximal slot therein. The distal surfaces of the respective ones of the upper and lower body portions can each define a distal slot therein.

The proximal wedge member can be disposed at the proximal ends of the respective ones of the upper and lower body portions. The proximal wedge member can comprise upper and lower guide members extending at least partially into the respective ones of the proximal slots of the upper and lower body portions with at least a portion of the proximal wedge member contacting the proximal surfaces of the upper and lower body portions. The distal wedge member can be disposed at the distal ends of the respective ones of the upper and lower body portions. The distal wedge member can comprise upper and lower guide members extending at least partially into the respective ones of the distal slots of the upper and lower body portions with at least a portion of the distal wedge member contacting the distal surfaces of the upper and lower body portions.

The actuator shaft can be received between the upper and lower body portions. The actuator shaft can extend intermediate the distal and proximal wedge members, wherein rotation of the actuator shaft causes the distal and proximal wedge members to be drawn together such that longitudinal movement of the distal wedge member against the distal surfaces and the longitudinal movement of the proximal wedge member against the proximal surfaces causes separation of the upper and lower body portions.

In such an embodiment, the upper body portion can further comprise a pair of downwardly extending side members and the lower body portion further comprises a pair of upwardly extending side members. The side members of the upper body portion can engage the side members of the lower body portion to facilitate linear translational movement of the upper body portion relative to the lower body portion. The side members of the upper body portion can each comprise a slot and the side members of the lower body portion each comprise a guide member. The guide members of the side members of the lower body portion can each be received into the slots of the side members of the upper body portion.

The implant can be configured wherein the proximal and distal surfaces of the upper and lower body portions are sloped. The slots of the proximal and distal surfaces of the upper and lower body portions can also be sloped. Further, the slots of the proximal and distal surfaces of the upper and lower body portions can be generally parallel to the respective proximal and distal surfaces of the upper and lower body portions. In other embodiments, the slots of the proximal and distal surfaces of the upper and lower body portions can be generally dove-tailed. The guide members of the proximal and distal wedge members can also be generally dovetailed. In other embodiments, the upper and lower body portions can comprise generally arcuate respective upper and lower exterior engagement surfaces.

The proximal wedge member can comprise an anti-rotational element. The anti-rotational engagement can be configured to be engaged by an implant tool for preventing rotation of the implant when the actuator shaft is rotated relative to the implant. The anti-rotational element can comprise a pair of apertures extending into the proximal wedge member.

In yet another embodiment, an implantation tool is provided for implanting an expandable intervertebral implant. The tool can comprise a handle section, a distal engagement section, and an anti-rotational engagement member. The handle section can comprise a fixed section and first and second rotatable members. The distal engagement section can comprise a fixed portion and first and second rotatable portions being operatively coupled to the respective ones of the first and second rotatable members. The first rotatable portion can comprise a distal attachment element. The distal engagement element can be operative to be removably attached to a distal end of at least a portion of the implant. The second rotatable portion can comprise a distal engagement member being configured to engage a proximal end of an actuator shaft of the implant for rotating the actuator shaft to thereby and expanding the implant from an unexpanded state to and expanded state. The anti-rotational engagement member can be used to engage an anti-rotational element of the implant.

In some embodiments, the first and second rotatable members of the tool can be coaxially aligned. Further, the first and second rotatable portions can be coaxially aligned. The first and second rotatable portions can be tubular, and the first rotatable portion can be disposed internally to the second rotatable portion. The fixed portion of the distal engagement section can be tubular and the first and second rotatable portions can be disposed internally to the fixed portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an intervertebral implant in an unexpanded state while positioned intermediate adjacent vertebrae, according to an embodiment.

FIG. 2 is a side view of the intervertebral implant shown in FIG. 1 in an expanded state.

FIG. 3 is a perspective view of the intervertebral implant shown in FIG. 1 in an unexpanded state.

FIG. 4 is a perspective view of the intervertebral implant shown in FIG. 3 in an expanded state.

FIG. 5 is a side cross sectional view of the intervertebral implant shown in FIG. 3 in an unexpanded state.

FIG. 6 is a side cross-sectional view of the intervertebral implant shown in FIG. 5 in an expanded state.

FIG. 7 is a side cross-sectional view of the intervertebral implant shown in FIG. 5 in an expanded state and wherein a portion of an actuator shaft has been removed.

FIG. 8 is a side cross sectional view of another embodiment of the actuator shaft of the intervertebral implant shown in FIG. 3, wherein the actuator shaft has an outer sleeve member and an inner sleeve member.

FIG. 9A is a side perspective view of a portion of a modified embodiment of the outer sleeve member.

FIG. 9B is an enlarged longitudinal cross-sectional view of a modified embodiment of the outer sleeve member with the portion shown in FIG. 9A.

FIG. 9C is a perspective view of another embodiment of an outer sleeve member.

FIGS. 9D and 9E are enlarged views of a portion of one embodiment of an outer sleeve member.

FIG. 9F is a front view of the outer sleeve member shown in FIG. 9C.

FIG. 10A is a side cross sectional view of another embodiment of an intervertebral implant.

FIG. 10B is an enlarged view of the section 10B shown in FIG. 10A.

FIG. 11 is a side cross-sectional view of another embodiment of an actuator shaft of the intervertebral implant shown in FIG. 10A.

FIG. 12 is a perspective view of the embodiment of the intervertebral implant shown in FIG. 10A in an unexpanded state.

FIG. 13 is a perspective view of the embodiment of the intervertebral implant shown in FIG. 10A in an expanded state.

FIG. 14A is a side view of another embodiment of the intervertebral implant wherein the upper and lower body portions have generally slanted configurations.

FIG. 14B is a top view of another embodiment of the intervertebral implant wherein the upper and lower body portions have semicircular upper and lower faces.

FIG. 14C is a top view of another embodiment of the intervertebral implant wherein the upper and lower body portions have generally square upper and lower faces.

FIG. 14D is a top view illustrating an embodiment of an application of the intervertebral implant utilizing a plurality of intervertebral implants disposed in an intervertebral space to support adjacent vertebrae.

FIG. 15 is a side cross-sectional view of another embodiment of the intervertebral implant wherein rotational movement can be utilized to expand the implant.

FIG. 16A is a perspective view of another embodiment of an intervertebral implant in an unexpanded state.

FIG. 16B is a perspective view of the intervertebral implant shown in FIG. 16A wherein the implant is in an expanded state.

FIG. 17 is a bottom view of the intervertebral implant shown in FIG. 16A.

FIG. 18 is a side view of the intervertebral implant shown in FIG. 16B.

FIG. 19 is a front cross-sectional view of the intervertebral implant shown in FIG. 16B taken along lines 19-19.

FIG. 20A is a bottom perspective view of a lower body portion of the intervertebral implant shown in FIG. 16A.

FIG. 20B is a top perspective view of the lower body portion of the intervertebral implant shown in FIG. 16A.

FIG. 21A is a bottom perspective view of an upper body portion of the intervertebral implant shown in FIG. 16A.

FIG. 21B is a top perspective view of the upper body portion of the intervertebral implant shown in FIG. 16A.

FIG. 22 is a perspective view of an actuator shaft of the intervertebral implant shown in FIG. 16A.

FIG. 23A is a front perspective view of a proximal wedge member of the intervertebral implant shown in FIG. 16A.

FIG. 23B is a rear perspective view of the proximal wedge member of the intervertebral implant shown in FIG. 16A.

FIG. 24A is a front perspective view of a distal wedge member of the intervertebral implant shown in FIG. 16A.

FIG. 24B is a rear perspective view of the distal wedge member of the intervertebral implant shown in FIG. 16A.

FIG. 25 is a perspective view of a deployment tool according to an embodiment.

FIG. 26 is a side cross-sectional view of the deployment tool shown in FIG. 25 wherein an expandable implant is attached to a distal end thereof.

DETAILED DESCRIPTION

In accordance with certain embodiments disclosed herein, an improved intervertebral implant is provided that allows the clinician to insert the intervertebral implant through a minimally invasive procedure. For example, in one embodiment, one or more intervertebral implants can be inserted percutaneously to reduce trauma to the patient and thereby enhance recovery and improve overall results of the surgery.

For example, in one embodiment, an intervertebral implant includes a plurality of body sections that are selectively separable and expandable upon contraction of a centrally disposed actuator. The actuator can be utilized to contract against faces of the body sections to cause the expansion thereof. The implant can also be configured such that the actuator provides for both the expansion and contraction of the body sections. The actuator can comprise an interaction between the body sections and another element, an action performed by another element, or a combination of interactions between various elements of the implant and its body sections. Further, the implant can be configured to allow either rough or fine incremental adjustments in the expansion of the implant.

The embodiments disclosed herein are discussed in the context of an intervertebral implant and spinal fusion because of the applicability and usefulness in such a field. As such, various embodiments can be used to properly space adjacent vertebrae in situations where a disc has ruptured or otherwise been damaged. As also disclosed herein, embodiments can also be used as vertebral body replacements. Thus, “adjacent” vertebrae can include those originally separated only by a disc or those that are separated by intermediate vertebra and discs. Such embodiments can therefore tend to recreate proper disc height and spinal curvature as required in order to restore normal anatomical locations and distances. However, it is contemplated that the teachings and embodiments disclosed herein can be beneficially implemented in a variety of other operational settings, for spinal surgery and otherwise.

For example, the implant disclosed herein can also be used as a vertebral body replacement. In such a use, the implant could be used as a replacement for a lumbar vertebra, such as one of the L1-L5 vertebrae. Thus, the implant could be appropriately sized and configured to be used intermediate adjacent vertebrae, or to entirely replace a damaged vertebra.

It is contemplated that the implant can be used as an interbody or intervertebral device or can be used to replace a vertebral body entirely. The implant can also be used in veterbal body compression fractures. Further, the implant can be used as a tool to expand an intervertebral space or bone in order to fill the space or bone with a cement; in such cases, the implant can be removed or left in once the cement is placed. Furthermore, the implant can also be used as a tool to predilate disc space. In some embodiments, the implant can be removed once the disc space is dilated, and a different implant (expandable or non-expandable) can then be implanted in the dilated disc space. Finally, the implant can also be introduced into the disc space anteriorly in an anterior lumbar interbody fusion (ALIF) procedure, posterior in an posterior lumbar interbody fusion (PILF) or posterial lateral interbody fusion, from extreme lateral position in an extreme lateral interbody fusion procedure, and transforaminal lumbar interbody fusion (TLIF), to name a few. Although the implant is primarily described herein as being used to expand in a vertical direction, it can also be implanted to expand in a horizontal direction in order to increase stability and/or increase surface area between adjacent vertebral bodies.

Additionally, the implant can comprise one or more height change mechanisms to facilitate expansion of the implant. For example, the implant can use a classic wedge system, a parallel bar and linkage system, a jack system, a pair of inclined planes, a screw jack system, a cam system, a balloon and bellows system, a hydraulic or pneumatic system, a longitudinal deformation/crush system (in which longitudinal contraction creates vertical expansion), or a stacking system, to name a few. Furthermore, the implant can comprise one or more height retention mechanisms. For example, the implant can use a pin ratchet system, a wedge ratchet system, a lead screw system with left or right-hand threads, or a lead screw system with left and right-hand threads, to name a few.

Therefore, it is contemplated that a number of advantages can be realized utilizing various embodiments disclosed herein. For example, as will be apparent from the disclosure, no external distraction of the spine is necessary. Further, no distraction device is required in order to install various embodiments disclosed herein. In this regard, embodiments of the implant can enable sufficient distraction of adjacent vertebra in order to properly restore disc height or to use the implant as a vertebral body replacement. Thus, normal anatomical locations, positions, and distances can be restored and preserved utilizing many of the embodiments disclosed herein.

Referring to FIG. 1, there is illustrated a side view of an embodiment of a intervertebral implant 10 in an unexpanded state while positioned generally between adjacent vertebrae of the lumbar portion of the spine 12. FIG. 2 illustrates the intervertebral implant 10 in an expanded state, thereby supporting the vertebrae in a desired orientation and spacing in preparation for spinal fusion. As is known in the art, spinal fusion is the process by which the adjacent vertebrae of the spine are united together (“fused”) so that motion no longer occurs between the vertebrae. Thus, the intervertebral implant 10 can be used to provide the proper spacing two vertebrae to each other pending the healing of a fusion. See also U.S. Patent Publication No. 2004/0127906, filed Jul. 18, 2003, application Ser. No. 10/623,193, the entirety of the disclosure of which is hereby incorporated by reference.

According to an embodiment, the implant can be installed in an operation that generally entails the following procedures. The damaged disc or vertebra can be decompressed, such as by distracting. The subject portion (or entire) disc or vertebra can then be removed. The adjacent vertebrae can be prepared by scraping the exposed adjacent portion or plates thereof (typically to facilitate bleeding and circulation in the area). Typically, most of the nucleus of the disc is removed and the annulus of the disc is thinned out. Although individual circumstances may vary, it may be unusual to remove all of the annulus or to perform a complete diskectomy. The implant can then be installed. In some embodiments, distraction of the disc may not be a separate step from placement of the implant; thus, distraction can be accomplished and can occur during placement of the implant. Finally, after implantation of the implant, osteogenic substances, such as autogenous bone graft, bone allograft, autograft foam, or bone morphogenic protein (BMP) can be strategically implanted adjacent the implant to prompt bone ingrowth in the intervertebral space. In this regard, as the implant is expanded, the spaces within the implant can be backfilled; otherwise, the implant can be prepacked with biologics.

The intervertebral implant is often used in combination with posterior and/or anterior fixation devices (e.g., rods, plates, screws, etc. that span two or more vertebrae) to limit movement during the fusion process. U.S. Patent Publication No. 2004/0127906 discloses a particularly advantageous posterior fixation device and method which secures two adjacent vertebra to each other in a trans-laminar, trans-facet or facet-pedicle (e.g., the Boucher technique) application using fixation screws.

It should also be appreciated that in FIGS. 1 and 2 only one intervertebral implant 10 is shown positioned between the vertebrae 12. However, as will be discussed in more detail below, it is anticipated that two, three or more implants 10 can be inserted into the space between the vertebrae. Further, other devices, such as bone screws, can be used on the vertebrae as desired. For example, in a spinal fusion procedure, it is contemplated that one or more implants 10 can be used in conjunction with one or more bone screws and/or dynamic stabilization devices, such as those disclosed in the above-mentioned U.S. Patent Publication No. 2004/0127906, filed Jul. 18, 2003, application Ser. No. 10/623,193.

In another embodiment of use, the implant 10 can be used in combination with a dynamic stabilization devices such as those disclosed in U.S. Patent Publication No. 2006-0122609, filed Feb. 11, 2005, application Ser. No. 11/056,991; U.S. Patent Publication No. 2005/0033289, filed on May 6, 2004, now U.S. Pat. No. 6,951,561; U.S. Provisional Patent Application No. 60/942,998, filed on Jun. 8, 2007; U.S. Provisional Application No. 60/397,588 filed Jul. 19, 2002; U.S. Provisional Application No. 60/424,055, filed Nov. 5, 2002; Ser. No. 10/623,193; U.S. Provisional Application No. 60/397,588 filed Jul. 19, 2002 and Provisional Application 60/424,055 filed Nov. 5, 2002; the entireties of the disclosures of which are hereby incorporated by reference. In this manner, the implant 10 can be used to maintain height between vertebral bodies while the dynamic stabilization device provides limits in one or more degrees of movement.

The embodiment of the intervertebral implant 10 shown FIGS. 1 and 2 will now be described in more detail with reference FIGS. 3 and 4. FIG. 3 illustrates a perspective view the intervertebral implant 10 in an unexpanded state while FIG. 4 illustrates the intervertebral implant 10 in an expanded state. The intervertebral implant 10 can comprise an upper body portion 14 and a lower body portion 16. The upper and lower body portions 14, 16 can each have a proximally facing surface 18, 20 disposed at respective proximal ends 22, 24 thereof and generally facing each other. As will be explained below, the proximally facing surfaces 18, 20 can be inclined or otherwise curved with respect to the longitudinal axis of the body portions 14, 16.

In the illustrated embodiment, the upper and lower body portions 14, 16 are illustrated as being configured substantially as parallel plate like structures. As will be explained below, the upper and lower body portions 14, 16 can be variously configured and designed, such as being generally ovular, wedge-shaped, and other shapes. For example, instead of including smooth exterior surfaces, as shown, the upper and lower body portions 14, 16 can be configured to include a surface texture, such as one or more external teeth, in order to ensure that the intervertebral implant 10 is maintained in a given lateral position once expanded intermediate the adjacent vertebrae of the spine 12. Other such modifications can be implemented in embodiments disclosed herein, and may be readily understood by one of skill in the art.

The intervertebral implant 10 can further comprise an actuator shaft 30 that can be sized and configured to be received between the upper and lower body portions 14, 16. As described herein with respect to various embodiments, the actuator shaft 30 can be utilized not only to move the intervertebral implant 10 from the unexpanded to the expanded state, but also to maintain expansion of the intervertebral implant 10. The actuator shaft 30 can be utilized in several embodiments to provide numerous advantages, such as facilitating precise placement, access, and rapid deployment of the intervertebral implant 10.

As shown in FIGS. 5 and 6, the actuator shaft 30 can comprise an inner member 32 and an outer sleeve member 34. In accordance with an embodiment, the outer sleeve member 34 can be adapted to be translatable relative to the inner member 32 such that the distance between the distal end of the inner member 32 and the proximal end of the outer member 34 can be reduced or shortened. The inner member 32 can have a distal end 36, a proximal end 38, and at least one retention structure 40 disposed therebetween. The outer sleeve member 32 can also have a proximal end 42 and at least one complementary retention structure 44.

In general, the retention structures 40, 44 between the inner member 32 and the outer member 34 can be configured such that facilitate selective relative movement of the proximal end 42 of the outer sleeve member 34 with respect to the distal end 36 of the inner member 32. While permitting such selective relative movement, the structures 40, 44 are preferably configured to resist movement once the distance between the proximal end 42 of the outer sleeve member 34 with respect to the distal end 36 of the inner member 32 is set. As will be described below, the retention structures 40, 44 can comprise any of a variety threads or screw-like structures, ridges, ramps, and/or ratchet type mechanisms which those of skill in the art will recognize provide such movement.

In some embodiments, the movement of proximal end 42 of the outer sleeve member 34, which may be in a direction distal to the clinician, can be accomplished without rotation of the actuator shaft 30, or any portion thereof. Thus, some embodiments provide that the actuator shaft 30 can be advantageously moved to the engaged position using only substantially longitudinal movement along an axis of the actuator shaft 30. It is contemplated that this axial translation of the outer sleeve member 34 can aid the clinician and eliminate cumbersome movements such as rotation, clamping, or otherwise. In this regard, the clinician can insert, place, and deploy the intervertebral implant 10 percutaneously, reducing the size of any incision in the patient, and thereby improving recovery time, scarring, and the like. These, and other benefits are disclosed herein.

In accordance with another embodiment, the proximal end 38 of the actuator shaft 30 can also be provided with a structure 48 for permitting releasable engagement with an installation or a removal tool 50. The actuator shaft 30 can therefore be moved as required and the tool 50 can later be removed in order to eliminate any substantial protrusions from the intervertebral implant 10. This feature can allow the intervertebral implant 10 to have a discreet profile once implanted into the patient and thereby facilitate healing and bone growth, while providing the clinician with optimal control and use of the intervertebral implant 10.

For example, as shown in FIG. 5, structure 48 comprises interacting threads between the distal end of the tool 50 and the proximal end 38 of the inner member 32. In a modified embodiment, the structure 48 can comprise any of a variety of fixation devices (e.g., hooks, latches, threads, etc.) as will be apparent to those of skill in the art. The actuator shaft 30 can therefore be securely coupled to the tool 50 during implantation of the intervertebral implant 10. Once disposed in the intervertebral space, the clinician can grasp the tool 50 to maintain the inner member 32 of the actuator shaft 30 at a constant position while pushing the outer sleeve member 34 in the distal direction and/or pull on the tool to proximally retract the inner member 32 while maintaining the outer member 34 stationary. Thus, the clinician can effectuate movement of the actuator shaft 30 and/or apply a force the actuator shaft 30. As will be described further below, this movement can thereby cause the intervertebral implant 10 to move from the unexpanded to the expanded state.

Alternatively, the tool 50 can be omitted and/or combined with the actuator shaft 30 such that the actuator shaft 30 includes a proximal portion that extends proximally in order to allow the clinician to manipulate the actuator shaft 30 position, as described with respect to the tool 50. In such an embodiment, the actuator shaft 30 can be provided with a first break point to facilitate breaking a proximal portion of the actuator shaft 30 which projects proximally of the proximal end 42 of the outer sleeve member 34 following tensioning of the actuator shaft 30 and expansion of the intervertebral implant 10. The break point can comprise an annular recess or groove, which can provide a designed failure point if lateral force is applied to the proximal portion while the remainder of the attachment system is relatively securely fixed in the intervertebral space. At least a second break point can also be provided, depending upon the axial range of travel of the outer sleeve member 34 with respect to the inner member 32. Other features and embodiments can be implemented as described in U.S. Pat. No. 6,951,561, the disclosure of which is hereby incorporated by reference in its entirety.

The retention structures 40, 44 of the inner member 32 and the outer sleeve member 34 can thus permit proximal movement of the inner member 32 with respect to the outer sleeve member 34 but resist distal movement of the inner member 32 with respect to the outer sleeve member 34. As the outer sleeve member 34 moves in the distal direction, the complementary retention structures 44 can engage the retention structures 40 of the inner member 32 to allow advancement of the outer sleeve member 34 in a distal direction with respect to inner member 32, but which resist proximal motion of outer sleeve member with respect to inner member 32. This can result in one-way or ratchet-type movement. Thus, in such an embodiment, at least one of the complementary retention structures 44 and the retention structures can comprise a plurality of annular rings, ramps, or ratchet-type structures. As mentioned above, any of a variety of ratchet-type structures can be utilized.

The actuator shaft 30 can also be configured to include a noncircular cross section or to have a rotational link such as an axially-extending spline on the inner member 32 for cooperating with a complementary keyway on the outer sleeve member 34. In another embodiment, the retention structures 40, 44 can be provided on less than the entire circumference of the inner member 32 or outer sleeve member 34, as will be appreciated by those of skill in the art. Thus, ratchet structures can be aligned in an axial strip such as at the bottom of an axially extending channel in the surface of the inner member 32. In this manner, the outer sleeve member 34 can be rotated to a first position to bypass the retention structures 40, 44 during axial advancement and then rotated to a second position to engage the retention structures 40, 44.

In accordance with another embodiment, the retention structures 40 of the inner member 32 can comprise a plurality of threads, adapted to cooperate with the complimentary retention structures 44 on the outer sleeve member 34, which may be a complimentary plurality of threads. In such an embodiment, the outer sleeve member 34 can be distally advanced along the inner member 32 by rotation of the outer sleeve member 34 with respect to the inner member 32, thus causing expansion of the intervertebral implant 10. The outer sleeve member 34 can also advantageously be removed from the inner member 32 by reverse rotation, such as to permit contraction of the intervertebral implant 10 to the unexpanded state in order to adjust the position thereof within the intervertebral space or to facilitate the removal of the intervertebral implant 10 from the patient.

For such a purpose, the outer sleeve member 34 can be preferably provided with a gripping configuration, structure, or collar 52 (see e.g., FIG. 7) to permit a removal instrument to rotate the outer sleeve member 34 with respect to the inner member 32. For example, such an instrument can be concentrically placed about the tool 50 and engage the collar 52. Thus, while holding the tool 50 in a fixed position, the clinician can reverse rotate the instrument to move the outer sleeve member 34 in a proximal direction. Any of a variety of gripping configurations may be provided, such as one or more slots, flats, bores, or the like. In the illustrated embodiment, the collar 52 can be provided with a polygonal, and in particular, a hexagonal circumference, as seen in FIGS. 7 and 8.

Various embodiments and/or additional or alternative components of the actuator shaft 30 and the retention structures 40, 44 can be found in U.S. Patent Publication 2004/0127906 (U.S. patent application Ser. No. 10/623,193, filed Jul. 18, 2003) entitled “METHOD AND APPARATUS FOR SPINAL FUSION”, which is hereby incorporated by reference. Additional embodiments and/or alternative components of the actuator shaft 30 can be found in U.S. patent application Ser. No. 60/794,171, filed on Apr. 21, 2006, U.S. Pat. Nos. 6,951,561, 6,942,668, 6,908,465, and 6,890,333, which are also incorporated by reference. For example, as described in U.S. Pat. No. 6,951,561, the actuator shaft 30 can be configured with particular spacing between the retention structures 40, 44; the actuator shaft 30 dimensions, such as diameter and cross-section, can be variously configured; and the actuator shaft 30 can be manufactured of various types of materials.

FIGS. 9A and 9B illustrate a portion of a modified embodiment of an outer sleeve member and inner member that is similar to the embodiments described above. In this embodiment, the outer sleeve member preferably includes a recess 54 configured to receive an annular ring 55. In an embodiment, the annular ring 55 can be a split ring (i.e., having a least one gap) and can be interposed between the inner member 32 and the proximal recess 54 of the outer sleeve member. In another embodiment, the ring 55 can be formed from an elastic material configured to ratchet over and engage with the inner member 32. In the split ring embodiment, the ring 55 comprises a tubular housing 56 that may be configured to engage with the inner member 32 and defines a gap or space 57. In one embodiment, the gap 57 is defined by a pair of edges 58, 59. The edges 58, 59 can be generally straight and parallel to each other. However, the edges 58, 59 can have any other suitable configuration and orientation.

For example, in one embodiment, the edges 58, 59 are curved and at an angle to each other. Although not illustrated, it should be appreciated that in modified embodiments, the ring 55 can be formed without a gap. When the ring 55 is positioned along the inner member 32, the ring 55 preferably surrounds a substantial portion of the inner member 32. The ring 55 can be sized so that the ring 55 can flex or move radially outwardly in response to an axial force so that the ring 55 can be moved relative to the inner member 32. In one embodiment, the tubular housing 56 includes at least one and in the illustrated embodiment four teeth or flanges 60, which are configured to engage the retention structures 40 on the inner member 32. In the illustrated embodiment, the teeth or flanges include a first surface that generally faces the proximal direction and is inclined with respect to the longitudinal axis of the outer sleeve member and a second surface that faces distal direction and lies generally perpendicular to the longitudinal axis of the outer sleeve member. It is contemplated that the teeth or flanges 60 can have any suitable configuration for engaging with the retention structures 40 of the inner member 32.

As with the previous embodiment, the outer sleeve member can includes the annular recess 54 in which the annular ring 55 may be positioned. The body 56 of the ring 55 can be sized to prevent substantial axial movement between the ring 55 and the annular recess 54 (FIG. 9B) during use of the outer sleeve member. In one embodiment, the width of the annular recess 54 in the axial direction is slightly greater than the width of the annular ring 55 in the axial direction. This tolerance between the annular recess 54 and the annular ring 55 can inhibit, or prevent, oblique twisting of the annular ring 55 so that the body 56 of the ring 55 is generally parallel to the outer surface of the inner member 32.

Further, the recess 54 can be sized and dimensioned such that as the outer sleeve member is advanced distally over the inner member 32, the annular ring 55 can slide along the first surface and over the complementary retention structures 40 of the inner member 32. That is, the recess 54 can provide a space for the annular ring 55 to move radially away from the inner member 32 as the outer sleeve member is advanced distally. Of course, the annular ring 55 can be sized and dimensioned such that the ring 55 is biased inwardly to engage the retention structures 40 on the inner member 32. The bias of the annular ring 55 can result in effective engagement between the flanges 60 and the retention structures 40.

A distal portion 61 of the recess 54 can be sized and dimensioned such that after the outer sleeve member 53 is appropriately tensioned the annular ring 55 becomes wedged between the inner member 32 and an angled engagement surface of the distal portion 61. In this manner, proximal movement of the outer sleeve member 53 can be prevented.

FIGS. 9C-9F illustrate another embodiment of an outer sleeve member 53′. In this embodiment, the outer sleeve member 53′ includes a recess 54 configured to receive a split ring 55, as described above with reference to FIGS. 9A and 9B. As will be explained in detail below, the outer sleeve member 53′ can include an anti-rotation feature to limit or prevent rotation of the ring 55 within the outer sleeve member 53. In light of the disclosure herein, those of skill in the art will recognize various different configurations for limiting the rotation of the ring 55. However, a particularly advantageous arrangement will be described below with reference to the illustrated embodiment.

In the illustrated embodiment, the outer sleeve member 53′ has a tubular housing 62 that can engage with the inner member 32 or the tool 50, as described above. With reference to FIGS. 9D and 9F, the tubular housing 62 can comprise one or more anti-rotational features 63 in the form of a plurality of flat sides that are configured to mate corresponding anti-rotational features 64 or flat sides of the inner member 32 of the actuator shaft 30. As shown in FIG. 9F, in the illustrated embodiment, the inner member 32 has three flat sides 64. Disposed between the flat sides 64 are the portions of the inner member 32 which include the complementary locking structures such as threads or ratchet like structures as described above. The complementary locking structures interact with the ring 55 as described above to resist proximal movement of the outer sleeve member 53′ under normal use conditions while permitting distal movement of the outer sleeve member 53′ over the inner member 32.

As mentioned above, the ring 55 can be is positioned within the recess 54. In the illustrated embodiment, the recess 54 and ring 55 are positioned near to and proximal of the anti-rotational features 63. However, the ring 55 can be located at any suitable position along the tubular housing 62 such that the ring 55 can interact with the retention features of the inner member 32.

During operation, the ring 55 may rotate to a position such that the gap 57 between the ends 58, 59 of the ring 55 lies above the complementary retention structures on the inner member 32. When the ring 55 is in this position, there is a reduced contact area between the split ring 55 the complementary retention structures thereby reducing the locking strength between the outer sleeve member 53′ and the inner member 32. In the illustrated embodiment, for example, the locking strength may be reduced by about ⅓ when the gap 57 over the complementary retention structures between flat sides 64. As such, it is advantageous to position the gap 57 on the flat sides 64 of the inner member 32 that do not include complementary retention structures.

To achieve this goal, the illustrated embodiment includes a pair of tabs 65, 66 that extend radially inward from the interior of the outer sleeve member 53′. The tabs 65, 66 are configured to limit or prevent rotational movement of the ring 55 relative to the housing 62 of the outer sleeve member 53′. In this manner, the gap 57 of the ring 55 may be positioned over the flattened sides 64 of the inner member 32.

In the illustrated embodiment, the tabs 65, 66 have a generally rectangular shape and have a generally uniform thickness. However, it is contemplated that the tabs 65, 66 can be square, curved, or any other suitable shape for engaging with the ring 55 as described herein.

In the illustrated embodiment, the tabs 65, 66 can be formed by making an H-shaped cut 67 in the tubular housing 62 and bending the tabs 65, 66 inwardly as shown in FIG. 9F. As shown in FIG. 9F, the tabs 65, 66 (illustrated in phantom) are interposed between the edges 58, 59 of the ring 55. The edges 58, 59 of the ring 55 can contact the tabs to limit the rotational movement of the ring 55. Those skilled in the art will recognize that there are many suitable manners for forming the tabs 65, 66. In addition, in other embodiments, the tabs 65, 66 may be replaced by a one or more elements or protrusions attached to or formed on the interior of the outer sleeve member 53′.

Referring again to FIGS. 3-6, the actuator shaft 30 can also comprise at least one proximal wedge member 68 being disposed at the proximal end 42 of the outer sleeve member 34. The proximal wedge member 68 can be sized and configured to contact the proximal facing surfaces 18, 20 of the upper and lower body portions 14, 16 upon selective relative movement of the proximal end 42 of the outer sleeve member 34 toward the distal end 36 of the inner member 32. The longitudinal movement of the proximal wedge member 68 against the proximal surfaces 18, 20 can cause the separation of the upper and lower body portions 14, 16 in order to cause the intervertebral implant 10 to expand from the unexpanded state to the expanded state, as shown in FIGS. 5 and 6, respectively.

As illustrated in FIGS. 3-6, the proximal wedge member 68 can be formed separately from the outer sleeve member 34. In such an embodiment, proximal wedge member 68 can be carried on a ring or wedge-type structure that is fitted around or over the outer sleeve member 34. In the illustrated embodiment, the proximal wedge member 68 can taper axially in the distal direction. For example, as shown in FIGS. 3 and 4, the proximal wedge member 68 can have a triangle-like structure that is disposed about the actuator shaft 30 and pushed against the proximal surfaces 18, 20 by the collar 52 of the outer sleeve member 34.

However, in other embodiments, as shown in FIG. 8, the proximal wedge member 68 can also be integrally formed with and/or permanently coupled to the outer sleeve member 34. Such an embodiment can be advantageous in that fewer parts are required, which can facilitate manufacturing and use of the intervertebral implant 10.

Preferably, the proximal surfaces 18, 20 of the upper and lower body portions 14, 16 are configured to substantially match the outer configuration of the proximal wedge member 68. The proximal surfaces 18, 20 can be integrally formed with the upper and lower body portions 14, 16 and have a shape that generally tapers toward the proximal ends 22, 24. The proximal surfaces 18, 20 can be defined by a smooth and constant taper, a non-constant curve, or a contact curve, or other geometries as may be appropriate.

For example, curvature proximal surfaces 18, 20 can be advantageous because initial incremental movement of the proximal wedge member 68 relative to the distal end 36 of the inner member 32 can result in relatively larger incremental distances between the upper and lower body portions 14, 16 than may subsequent incremental movement of the proximal wedge member 68. Thus, these types of adjustments can allow the clinician to quickly expand the intervertebral implant 10 to an initial expanded state with few initial incremental movements, but to subsequently expand the intervertebral implant 10 in smaller and smaller increments in order to fine tune the placement or expanded state of the intervertebral implant 10. Thus, such embodiments can allow the efficiency of the operation to be improved and allow the clinician to fine tune the expansion of the intervertebral implant 10.

With reference to FIGS. 1 and 5, in the illustrated embodiment, the upper and lower body portions 14, 16 can each have distally facing distal surfaces 70, 72 disposed at distal ends 74, 76 thereof, as similarly mentioned above with respect to the proximal surfaces 18, 20. For example, the distal surfaces 70, 72 can be inclined or otherwise curved with respect to the longitudinal axis of the body portions 14, 16. Other features, designs, and configurations of the proximal surfaces 18, 20, as disclosed herein, are not repeated with respect to the distal surfaces 70, 72, but it is understood that such features, designs, and configurations can similarly be incorporated into the design of the distal surfaces 70, 72.

In such an embodiment, the actuator shaft 30 of the intervertebral implant 10 can further comprise at least one distal wedge member 80 that can be disposed at the distal end 36 of the inner member 32. The distal wedge member 80 can be sized and configured to contact the distal surfaces 70, 72 of the respective ones of the upper and lower body portions 14, 16 upon selective relative movement of the distal end 36 of the inner member 32 toward the proximal end 42 of the outer sleeve member 34. As similarly described above with respect to the proximal wedge member 68, the longitudinal movement of the distal wedge member 80 against the distal surfaces 70, 72 can cause the separation of the upper and lower body portions 14, 16 thereby resulting in expansion of the intervertebral implant 10.

The description of the proximal wedge member 68 and its interaction with the proximal surfaces 18, 20, as well as the corresponding structures and embodiments thereof, can likewise be implemented with respect to the distal wedge member 80 and the distal surfaces 70, 72. Therefore, discussion of alternative embodiments, structures, and functions of the distal wedge member 80 and the distal surfaces 70, 72 need not be repeated in detail, but can include those mentioned above with respect to the distal wedge member 80 and the distal surfaces 70, 72.

In accordance with yet another embodiment illustrated in FIGS. 10A-11, at least one of the proximal and distal wedge members 68, 80 can be configured to include engagement surfaces 90, 92. The engagement surfaces 90, 92 can include any variety of surface textures, such as ridges, protrusions, and the like in order to enhance the engagement between the proximal and distal wedge members 68, 80 and the respective ones of the proximal and distal surfaces 18, 20 and 70, 72. In the embodiment illustrated in FIGS. 10A-11, the engagement surfaces 90, 92 can include stepped contours 94, 96, such as comprising a plurality of ridges.

As illustrated in the detail section view of FIG. 10B, the stepped contours 94, 96 of the engagement surfaces 90, 92 can be preferably configured to be inclined or oriented obliquely with respect to the axis of the actuator shaft 30. The use of the engagement surfaces 90, 92 can permit one-way, ratchet type longitudinal movement of proximal and distal wedge members 68, 80 relative to the proximal and distal surfaces 18, 20 and 70, 72 in order to maintain the upper and lower body portions 14, 16 at a given separation distance.

Additionally, at least one of the proximal and distal surfaces 18, 20 and 70, 72 of the upper and lower body portions 14, 16 can include complimentary engagement surfaces 100, 102, 104, 106. The complimentary engagement surfaces 100, 102, 104, 106 can similarly include any variety of surface textures, such as ridges, protrusions, and the like in order to enhance the engagement between the respective ones of the distal and proximal protrusions 68, 80.

In accordance with the embodiment shown in FIGS. 10A-11, the complimentary engagement surfaces 100, 102, 104, 106 can be configured as stepped contours 108, 110 and 112, 114, such as including a plurality of ridges. As shown best in the detail section view of FIG. 10, the stepped contours 108, 110, 112, 114 can also be configured to be inclined or oriented obliquely with respect to the axis of the actuator shaft 30. However, the stepped contours 108, 110, 112, 114 are preferably inclined in a direction opposite to the stepped contours 94, 96 of the proximal and distal wedge members 68, 80.

In such an embodiment, the stepped contours 108, 110, 112, 114 can engage the stepped contours 94, 96 of the wedge members 68, 80 to permit one-way ratcheting of the proximal and distal wedge members 68, 80 along the proximal and distal surfaces 18, 20, 70, 72. This advantageous feature can be incorporated into various embodiments disclosed herein in order to, inter alia, further improve the deployment and stabilization of the intervertebral implant 10.

As shown in FIG. 10A, in this embodiment, the inner member 32 and the outer sleeve member 34 do not include complementary retention structures as described above with reference to FIGS. 3 and 4. Thus, in this embodiment the inner members 32 can be moved with respect to the outer sleeve member 34, and the above-described engagement between the proximal and distal wedge members 68, 80 and the respective ones of the distal and proximal surfaces 18, 20 and 70, 72 can provide ratchet-type movement and maintain expansion of the implant 10. However, in modified embodiments, the retention structures 40, 44 of the actuator shaft 30 can also be provided in addition to the engagement of the proximal and distal wedge members 68, 80 and the respective ones of the distal and proximal surfaces 18, 20 and 70, 72.

Referring again to FIGS. 3 and 4, according to the illustrated embodiment, the intervertebral implant 10 can further comprise at least one alignment guide 120. The alignment guide 120 can be connected to the upper and lower body portions 14, 16 and be operative to facilitate separation of the first and second body portions 14, 16. As shown in FIGS. 3 and 4, the alignment guide 120 can comprise a plurality of guide rods 122 that are disposed through corresponding bores in the upper and lower body portions 14, 16. The rods 122 can be configured to orient the upper body portion 14 substantially orthogonally with respect to an axis of the actuator shaft 30 and with respect to the lower body portion 16. In such an embodiment, the rods 122 can each include a telescoping mechanism to enable and stabilize expansion of the intervertebral implant 30. Preferably, the alignment guide 120 also facilitates expansion or separation of the upper and lower body portions 14, 16 in a direction substantially orthogonal to an axis of the actuator shaft 30, such as in the axial direction of the rods 122.

In accordance with another embodiment illustrated in FIGS. 12 and 13, the alignment guide 120 can also be configured to include a first pair of side rails 130 extending from the upper body portion 14 toward the lower body portion 16 for aligning the upper body portion 14 with the lower body portion 16 to facilitate separation of the upper and lower body portions 14, 16 in a direction substantially orthogonal to an axis of the actuator shaft 30. Further, the alignment guide 120 can also include a second pair of side rails 132 extending from the lower body portion 16 toward the upper body portion 14 for cooperating with the first pair of side rails 130 in aligning the upper body portion 14 with the lower body portion 16 to facilitate separation of the upper and lower body portions 14, 16 in a direction substantially orthogonal to the axis of the actuator shaft 30.

As shown, the first and second pairs of side rails 130, 132 can be configured to extend substantially orthogonally from the respective ones of the upper and lower body portions 14, 16. In this regard, although the upper and lower body portions 14, 16 are illustrated as being configured substantially as parallel plates, any variety of configurations can be provided, such as generally ovular, wedge-shaped, and others, as mentioned above. Thus, the first and second pairs of side rails 130, 132 can be configured accordingly depending upon the configuration and design of the upper and lower body portions 14, 16.

For example, it is contemplated that the first and second pairs of side rails 130, 132 can be configured to ensure that the spacing between the proximal ends 22, 24 of the respective ones of the upper and lower body portions 14, 16 is equal to the spacing between the distal ends 74, 76 thereof. However, the first and second pairs of side rails 130, 132 can also be configured to orient exterior surfaces of the upper and lower body portions 14, 16 at an oblique angle relative to each other. Thus, the spacing between the proximal ends 22, 24 of the respective ones of the upper and lower body portions 14, 16 can be different from the spacing between the distal ends 74, 76 thereof. Thus, in one embodiment, such orientation can be created depending upon the desired configuration of the first and second pairs of side rails 130, 132.

Further, it is contemplated that the first and second pairs of side rails 130, 132 can be linear or planar in shape, as well as to generally conform to the shape of a curve in the longitudinal direction. Furthermore, the first and second pairs of side rails 130, 132 can also be configured to include mating surfaces to facilitate expansion and alignment of the intervertebral implant 10. Finally, the first and second pairs of side rails 130, 132, although illustrated as solid, can include perforations or other apertures to provide circulation through the intervertebral space.

In accordance with yet another embodiment, a method of implanting or installing the spinal fusion implant 10 is also provided. The method can comprise the steps of positioning the intervertebral implant 10 between two vertebral bodies and moving the inner member 32 of the actuator shaft 30 in an proximal direction relative to the outer sleeve member 34 to force the proximal wedge member 68 and distal wedge member 80 against the proximal and distal surfaces 18, 20, 70, 72 of upper and lower body portions 14, 16 of the intervertebral implant 10 to separate the upper and lower body portions 14, 16 to cause the intervertebral implant 10 to expand intermediate the vertebral bodies. The method can be accomplished utilizing the various embodiments as described herein.

For any of the embodiments disclosed above, installation can be simplified through the use of the installation equipment. The installation equipment can comprise a pistol grip or plier-type grip so that the clinician can, for example, position the equipment at the proximal extension of actuator shaft 30, against the proximal end 42 of the outer sleeve member 34, and through one or more contractions with the hand, the proximal end 42 of the outer sleeve member 34 and the distal end 36 of the inner member 32 can be drawn together to appropriately tension.

In particular, while proximal traction is applied to the proximal end 38 of the inner member 32, appropriate tensioning of the actuator shaft 30 is accomplished by tactile feedback or through the use of a calibration device for applying a predetermined load on the actuator shaft 30. Following appropriate tensioning of the actuator shaft 30, the proximal extension of the actuator shaft 30 (or the tool 50) is preferably removed, such as by being unscrewed, cut off or snapped off. Such a cut can be made using conventional saws, cutters or bone forceps which are routinely available in the clinical setting.

In certain embodiments, the proximal extension of the actuator shaft 30 may be removed by cauterizing. Cauterizing the proximal extension may advantageously fuse the proximal end 38 of the inner member 32 to the distal end 42 of the outer sleeve member 34, thereby adding to the retention force between the outer sleeve member 34 and the inner member 30 and between the proximal and distal protrusions 68, 80 and the respective ones of the distal and proximal surfaces 18, 20 and 70, 72, if applicable. Such fusion between the proximal end 38 of the inner member 32 to the distal end 42 of the outer sleeve member 34 may be particularly advantageous if the intervertebral implant 10 is made from a bioabsorbable and/or biodegradable material. In this manner, as the material of the proximal anchor and/or the actuator shaft is absorbed or degrades, the fusion caused by the cauterizing continues to provide retention force between the proximal anchor and the pin.

Following trimming the proximal end of actuator shaft 30, the access site may be closed and dressed in accordance with conventional wound closure techniques.

Preferably, the clinician will have access to an array of intervertebral implants 10, having different widths and axial lengths. These may be packaged one or more per package in sterile envelopes or peelable pouches. Upon encountering an intervertebral space for which the use of a intervertebral implant 10 is deemed appropriate, the clinician will assess the dimensions and load requirements of the spine 12, and select an intervertebral implant 10 from the array which meets the desired specifications.

The embodiments described above may be used in other anatomical settings beside the spine. As mentioned above, the embodiments described herein may be used for spinal fixation. In embodiments optimized for spinal fixation in an adult human population, the upper and lower portions 14, 15 will generally be within the range of from about 10-60 mm in length and within the range of from about 5-30 mm in maximum width and the device can expand from a height of about 5 mm to about 30 mm.

For the embodiments discussed herein, the intervertebral implant components can be manufactured in accordance with any of a variety of techniques which are well known in the art, using any of a variety of medical-grade construction materials. For example, the upper and lower body portions 14, 16, the actuator shaft 30, and other components can be injection-molded from a variety of medical-grade polymers including high or other density polyethylene, PEEK™ polymers, nylon and polypropylene. Retention structures 40, 44 can also be integrally molded with the actuator shaft 30. Alternatively, retention structures 40, 44 can be machined or pressed into the actuator shaft 30 in a post-molding operation, or secured using other techniques depending upon the particular design. The retention structures 40, 44 can also be made of a different material.

The intervertebral implant 10 components can be molded, formed or machined from biocompatible metals such as Nitinol, stainless steel, titanium, and others known in the art. Non-metal materials such as plastics, PEEK™ polymers, and rubbers can also be used. Further, the implant components can be made of combinations of PEEK™ polymers and metals. In one embodiment, the intervertebral implant components can be injection-molded from a bioabsorbable material, to eliminate the need for a post-healing removal step.

The intervertebral implant components may contain one or more bioactive substances, such as antibiotics, chemotherapeutic substances, angiogenic growth factors, substances for accelerating the healing of the wound, growth hormones, antithrombogenic agents, bone growth accelerators or agents, and the like. Such bioactive implants may be desirable because they contribute to the healing of the injury in addition to providing mechanical support.

In addition, the intervertebral implant components may be provided with any of a variety of structural modifications to accomplish various objectives, such as osteoincorporation, or more rapid or uniform absorption into the body. For example, osteoincorporation may be enhanced by providing a micropitted or otherwise textured surface on the intervertebral implant components. Alternatively, capillary pathways may be provided throughout the intervertebral implant, such as by manufacturing the intervertebral implant components from an open cell foam material, which produces tortuous pathways through the device. This construction increases the surface area of the device which is exposed to body fluids, thereby generally increasing the absorption rate. Capillary pathways may alternatively be provided by laser drilling or other technique, which will be understood by those of skill in the art in view of the disclosure herein. Additionally, apertures can be provided in the implant to facilitate packing of biologics into the implant, backfilling, and/or osseointegration of the implant. In general, the extent to which the intervertebral implant can be permeated by capillary pathways or open cell foam passageways may be determined by balancing the desired structural integrity of the device with the desired reabsorption time, taking into account the particular strength and absorption characteristics of the desired polymer.

The intervertebral implant may be sterilized by any of the well known sterilization techniques, depending on the type of material. Suitable sterilization techniques include heat sterilization, radiation sterilization, such as cobalt irradiation or electron beams, ethylene oxide sterilization, and the like.

Referring now to FIGS. 14A-14D, various modified configurations and applications of the implant are illustrated. As mentioned above, the embodiments, applications, and arrangements disclosed herein can be readily modified by one of skill in order to suit the requirements of the clinician. It will therefore be appreciated that embodiments disclosed herein are not limited to those illustrated, but can be combined and/or modified.

FIG. 14A is a side view of another embodiment of an intervertebral implant 10 wherein the upper and lower body portions 14, 16 have generally slanted configurations. As illustrated, the upper and lower body portions 14, 16 can define generally convex upper and lower surfaces 140, 142, respectively. Such an embodiment can be beneficial especially in applications where the implant 10 must complement the natural curvature of the spine. The upper and lower surfaces 140, 142 can generally match the concavity of adjacent upper and lower vertebral bodies. It will be appreciated that the slanted configuration can be modified and a range of curvatures can be accommodated as required. Furthermore, the upper and lower surfaces 140, 142 can be generally planar and oriented at an angle relative to each other. In some embodiments, the upper and lower surfaces 140, 142 of the implant 10 can be formed such that the implant defines a generally wedge-shaped design. The dimensions of the implant 10 can be varied as desired.

As illustrated in FIG. 14A, the upper and lower body portions 14, 16 can be configured such that exterior surfaces thereof are oriented obliquely with respect to interior surfaces thereof. For example, in some embodiments, the upper and lower body portions 14, 16 can be configured generally as wedges. However, as also mentioned with regard to FIGS. 12 and 13, it is also contemplated that the actuation mechanism of the implant can allow the spacing between the proximal ends of the respective ones of the upper and lower body portions to be different from of the spacing between the distal ends thereof due to the overall configuration of the implant.

In this regard, the angular relationship between the upper and lower body portions 14, 16 can be varied as desired. For example, the spacing of the distal ends of the upper and lower body portions 14, 16 can increase at a greater rate as the implant is expanded that the spacing between the proximal ends of the upper and lower body portions 14, 16, or vice versa. This feature can result from the interaction of the actuator shaft with the implant, the wedges with the upper and lower body portions 14, 16, or the actuator shaft with the wedges. It is contemplated, for example, that the distal and proximal wedges can have different configurations with different angular relationships between their contact surfaces. Further, the actuator shaft can have different thread configurations such that one wedge advances faster than the other wedge upon rotation of the pin. Alternative embodiments can also be developed based on the present disclosure.

Referring now to FIG. 14B, a top view of another embodiment of an intervertebral implant 10 is provided wherein the implant 10 has a generally clamshell configuration. Such an embodiment can be beneficial in applications where the clinician desires to support the vertebrae principally about their peripheral aspects.

For example, at least one of the upper and lower body portions 14, 16 can be configured to have a semicircular face. When such an embodiment is implanted and deployed in a patient, the outwardly bowed portions of the upper and lower body portions 14, 16 provide a footprint that allows the implant 10 to contact the vertebrae about their periphery, as opposed to merely supporting the vertebrae in a substantially central or axial location. In such embodiments, the upper and lower body portions 14, 16 can thus be banana or crescent shaped to facilitate contact with cortical bone. Thus, such embodiments can employ the more durable, harder structure of the periphery of the vertebrae to support the spine.

In an additional embodiment, FIG. 14C shows a top view of an intervertebral implant 10 illustrating that the implant 10 can have a generally square configuration and footprint when implanted into the intervertebral space of the spine 12. Such a configuration would likely be utilized in a more invasive procedure, rather than in percutaneous applications. As mentioned above with respect to FIG. 14B, the footprint of such an embodiment can allow the implant 10 to more fully contact the more durable, harder portions of the vertebrae to facilitate support and healing of the spine. Alternative embodiments can be created that provide ovular, circular, hexagonal, rectangular, and any other shaped footprint.

Furthermore, FIG. 14D is a top view of the spine 12 illustrating an exemplary application of the intervertebral implant. In this example, a plurality of intervertebral implants 10′ and 10″ (shown in hidden lines) can be disposed in an intervertebral space of the spine 12 to support adjacent vertebrae. As mentioned above, one of the beneficial aspects of embodiments of the implant provides that the implant can be used in percutaneous applications.

In FIG. 14D, it is illustrated that one or more implants 10′ can be implanted and oriented substantially parallel with respect to each other in order to support the adjacent vertebrae. Also shown, at least two implants 10″ can be implanted and oriented transversely with respect to each other in order to support the adjacent vertebrae. In addition, it is contemplated that a cross-midline approach can be used wherein a single implant is placed into the intervertebral space in an orientation as depicted for one of the implants 10′, although more centrally. Thus, the angular orientation of the implant(s) can be varied. Further, the number of implants used in the spinal fusion procedure can also be varied to include one or more. Other such configurations, orientations, and operational parameters are contemplated in order to aid the clinician in ensuring that the adjacent vertebrae are properly supported, and that such procedure is performed in a minimally invasive manner.

Referring now to FIG. 15, yet another embodiment is provided. FIG. 15 is a side view of an intervertebral implant 10 in an unexpanded state in which a screw mechanism 150 can be utilized to draw the proximal and distal wedged members 68, 80 together to cause the implant to move to an expanded state. Thus, a rotational motion, instead of a translational motion (as discussed above in reference to other embodiments) can be utilized to cause the implant 10 to move to its expanded state.

In some embodiments, the screw mechanism 150 can comprise an Archimedes screw, a jack bolt, or other fastener that can cause the convergence of two elements that are axially coupled to the fastener. The screw mechanism 150 can have at least one thread disposed along at least a portion thereof, if not along the entire length thereof. Further, the screw mechanism can be threadably attached to one or both of the proximal and distal wedge members 68, 80. As illustrated in FIG. 15, the distal wedge member 80 can also be freely rotatably attached to the screw mechanism 150 while the proximal wedge member 68 is threadably attached thereto. Further, as disclosed above with respect to the pin, the screw mechanism 150 can also be configured such that a proximal portion of the screw mechanism 150 can be removed after the implant 10 has been expanded in order to eliminate any proximal protrusion of the screw mechanism 150.

Therefore, in the illustrated embodiment, it is contemplated that upon rotation of the screw mechanism 150, the proximal and distal wedged members 68, 80 can be axially drawn closer together. As a result of this axial translation, the proximal and distal wedged members 68, 80 can contact the respective ones of the proximal and distal surfaces 18, 20 and 70, 72 in order to facilitate separation of the upper and lower body portions 14, 16, as similarly disclosed above.

The screw mechanism 150 can be utilized to provide a stabilizing axial force to the proximal and distal wedge members 68, 80 in order to maintain the expansion of the implant 10. However, it is also contemplated that other features can be incorporated into such an embodiment to facilitate the maintenance of the expansion. In this regard, although the axial force provided by the screw mechanism 150 can tend to maintain the position and stability of the proximal and distal wedge members 68, 80, additional features can be employed to ensure the strength and stability of the implant 10 when in its expanded state.

For example, as discussed above with respect to FIGS. 10A-10B, the proximal and distal wedge members 68, 80 can include engagement surfaces 90, 92, such as stepped contours 94, 96. As discussed above, the use of the engagement surfaces 90, 92 can permit one-way, ratchet type longitudinal movement of proximal and distal wedge members 68, 80 relative to the proximal and distal surfaces 18, 20 and 70, 72 in order to maintain the upper and lower body portions 14, 16 at a given separation distance.

Furthermore, as also disclosed above, at least one of the proximal and distal surfaces 18, 20 and 70, 72 of the upper and lower body portions 14, 16 can include complimentary engagement surfaces 100, 102, 104, 106 to enhance the engagement between the respective ones of the distal and proximal protrusions 68, 80. In an embodiment, the complimentary engagement surfaces 100, 102, 104, 106 can be configured as stepped contours 108, 110 and 112, 114. Thus, the stepped contours 108, 110, 112, 114 can engage the stepped contours 94, 96 of the wedge members 68, 80 to permit one-way ratcheting of the proximal and distal wedge members 68, 80 along the proximal and distal surfaces 18, 20, 70, 72.

Therefore, some embodiments can be configured such that a rotational motion can be exerted on the actuator shaft or screw mechanism, instead of a pulling or translational motion, in order to expand an embodiment of the implant from an unexpanded state (such as that illustrated in FIG. 12) to an expanded state (such as that illustrated in FIG. 13). Such embodiments can be advantageous in certain clinical conditions and can provide the clinician with a variety of options for the benefit of the patient. Further, the various advantageous features discussed herein with respect to other embodiments can also be incorporated into such embodiments.

Referring now to FIG. 16A-19, another embodiment of the implant is illustrated. FIG. 16A is a perspective view of an intervertebral implant 200 in an unexpanded state. The implant 200 can comprise upper and lower body portions 202, 204, proximal and distal wedge members 206, 208, and an actuator shaft 210. In the unexpanded state, the upper and lower body portions 202, 204 can be generally abutting with a height of the implant 200 being minimized. However, the implant 200 can be expanded, as shown in FIG. 16B to increase the height of the implant 200 when implanted into the intervertebral space of the spine.

In some embodiments, the height of the implant 200 can be between approximately 7-15 mm, and more preferably, between approximately 8-13 mm. The width of the implant can be between approximately 7-11 mm, and preferably approximately 9 mm. The length of the implant 200 can be between approximately 18-30 mm, and preferably approximately 22 mm. Thus, the implant 200 can have a preferred aspect ratio of between approximately 7:11 and 15:7, and preferably approximately between 8:9 and 13:9. It is contemplated that various modifications to the dimension disclosed herein can be made by one of skill and the mentioned dimensions shall not be construed as limiting.

Additionally, as noted above, the implant 200 can also be made using non-metal materials such as plastics, PEEK™ polymers, and rubbers. Further, the implant components can be made of combinations of PEEK™ polymers and metals. Accordingly, the implant 200 can be at least partially radiolucent, which radiolucency can allow a doctor to perceive the degree of bone growth around and through the implant. The individual components of the implant 200 can be fabricated of such materials based on needed structural, biological and optical properties.

As discussed generally above with respect to FIG. 15, it is contemplated that the actuator shaft 210 can be rotated to cause the proximal and distal wedge members to move toward each other, thus causing the upper and lower body portions 202, 204 to be separated. Although, the present embodiment is illustrated using this mode of expansion, it is contemplated that other modes of expansion described above (e.g., one way-ratchet type mechanism) can be combined with or interchanged herewith.

In some embodiments, the implant 200 can be configured such that the proximal and distal wedge members 206, 208 are interlinked with the upper and lower body portions 202, 204 to improve the stability and alignment of the implant 200. For example, the upper and lower body portions 202, 204 can be configured to include slots (slot 220 is shown in FIG. 16A, and slots 220, 222 are shown in FIG. 16B; the configuration of such an embodiment of the upper and lower body portions 202, 204 is also shown in FIGS. 20A-21B, discussed below). In such an embodiment, the proximal and distal wedge members 206, 208 can be configured to include at least one guide member (an upper guide member 230 of the proximal wedge member 206 is shown in FIG. 16A and an upper guide member 232 of the distal wedge member 208 is shown in FIG. 18) that at least partially extends into a respective slot of the upper and lower body portions. The arrangement of the slots and the guide members can enhance the structural stability and alignment of the implant 200.

In addition, it is contemplated that some embodiments of the implant 200 can be configured such that the upper and lower body portions 202, 204 each include side portions (shown as upper side portion 240 of the upper body portion 202 and lower side portion 242 of the lower body portion 204) that project therefrom and facilitate the alignment, interconnection, and stability of the components of the implant 200. FIG. 16B is a perspective view of the implant 200 wherein the implant 200 is in the expanded state. The upper and lower side portions 240, 242 can be configured to have complementary structures that enable the upper and lower body portions 202, 204 to move in a vertical direction. Further, the complementary structures can ensure that the proximal ends of the upper and lower body portions 202, 204 generally maintain spacing equal to that of the distal ends of the upper and lower body portions 202, 204. The complementary structures are discussed further below with regard to FIGS. 17-21B.

Furthermore, as described further below, the complementary structures can also include motion limiting portions that prevent expansion of the implant beyond a certain height. This feature can also tend to ensure that the implant is stable and does not disassemble during use.

In some embodiments, the actuator shaft 210 can facilitate expansion of the implant 200 through rotation, longitudinal contract of the pin, or other mechanisms. The actuator shaft 210 can include threads that threadably engage at least one of the proximal and distal wedge members 206, 208. The actuator shaft 210 can also facilitate expansion through longitudinal contraction of the actuator shaft as proximal and distal collars disposed on inner and outer sleeves move closer to each other to in turn move the proximal and distal wedge members closer together, as described above with respect to actuator shaft 30 shown in FIGS. 5-6. It is contemplated that in other embodiments, at least a portion of the actuator shaft can be axially fixed relative to one of the proximal and distal wedge members 206, 208 with the actuator shaft being operative to move the other one of the proximal and distal wedge members 206, 208 via rotational movement or longitudinal contraction of the pin.

Further, in embodiments wherein the actuator shaft 210 is threaded, it is contemplated that the actuator shaft 210 can be configured to bring the proximal and distal wedge members closer together at different rates. In such embodiments, the implant 200 could be expanded to a V-configuration or wedged shape. For example, the actuator shaft 210 can comprise a variable pitch thread that causes longitudinal advancement of the distal and proximal wedge members at different rates. The advancement of one of the wedge members at a faster rate than the other could cause one end of the implant to expand more rapidly and therefore have a different height that the other end. Such a configuration can be advantageous depending on the intervertebral geometry and circumstantial needs.

In other embodiments, the implant 200 can be configured to include anti-torque structures 250. The anti-torque structures 250 can interact with at least a portion of a deployment tool during deployment of the implant to ensure that the implant maintains its desired orientation (see FIGS. 25-26 and related discussion). For example, when the implant 200 is being deployed and a rotational force is exerted on the actuator shaft 210, the anti-torque structures 250 can be engaged by a non-rotating structure of the deployment tool to maintain the rotational orientation of the implant 200 while the actuator shaft 210 is rotated. The anti-torque structures 250 can comprise one or more inwardly extending holes or indentations on the proximal wedge member 206, which are shown as a pair of holes in FIGS. 16A-B. However, the anti-torque structures 250 can also comprise one or more outwardly extending structures.

According to yet other embodiments, the implant 200 can be configured to include one or more apertures 252 to facilitate osseointegration of the implant 200 within the intervertebral space. As mentioned above, the implant 200 may contain one or more bioactive substances, such as antibiotics, chemotherapeutic substances, angiogenic growth factors, substances for accelerating the healing of the wound, growth hormones, antithrombogenic agents, bone growth accelerators or agents, and the like. Indeed, various biologics can be used with the implant 200 and can be inserted into the disc space or inserted along with the implant 200. The apertures 252 can facilitate circulation and bone growth throughout the intervertebral space and through the implant 200. In such implementations, the apertures 252 can thereby allow bone growth through the implant 200 and integration of the implant 200 with the surrounding materials.

FIG. 17 is a bottom view of the implant 200 shown in FIG. 16A. As shown therein, the implant 200 can comprise one or more protrusions 260 on a bottom surface 262 of the lower body portion 204. Although not shown in this FIG., the upper body portion 204 can also define a top surface having one or more protrusions thereon. The protrusions 260 can allow the implant 200 to engage the adjacent vertebrae when the implant 200 is expanded to ensure that the implant 200 maintains a desired position in the intervertebral space.

The protrusions 260 can be configured in various patterns. As shown, the protrusions 260 can be formed from grooves extending widthwise along the bottom surface 262 of the implant 200 (also shown extending from a top surface 264 of the upper body portion 202 of the implant 200). The protrusions 260 can become increasingly narrow and pointed toward their apex. However, it is contemplated that the protrusions 260 can be one or more raised points, cross-wise ridges, or the like.

FIG. 17 also illustrates a bottom view of the profile of an embodiment of the upper side portion 240 and the profile of the lower side portion 242. As mentioned above, the upper and lower side portions 240, 242 can each include complementary structures to facilitate the alignment, interconnection, and stability of the components of the implant 200. FIG. 17 also shows that in some embodiments, having a pair of each of upper and lower side portions 240, 242 can ensure that the upper and lower body portions 202, 204 do not translate relative to each other, thus further ensuring the stability of the implant 200.

As illustrated in FIG. 17, the upper side portion 240 can comprise a groove 266 and the lower side portion can comprise a rib 268 configured to generally mate with the groove 266. The groove 266 and rib 268 can ensure that the axial position of the upper body portion 202 is maintained generally constant relative to the lower body portion 204. Further, in this embodiment, the grooves 266 and rib 268 can also ensure that the proximal ends of the upper and lower body portions 202, 204 generally maintain spacing equal to that of the distal ends of the upper and lower body portions 202, 204. This configuration is also illustratively shown in FIG. 18.

Referring again to FIG. 17, the implant 200 is illustrated in the unexpanded state with each of the respective slots 222 of the lower body portion 204 and lower guide members 270, 272 of the respective ones of the proximal and distal wedge members 206, 208. In some embodiments, as shown in FIGS. 16A-17 and 19-21B, the slots and guide members can be configured to incorporate a generally dovetail shape. Thus, once a given guide member is slid into engagement with a slot, the guide member can only slide longitudinally within the slot and not vertically from the slot. This arrangement can ensure that the proximal and distal wedge members 206, 208 are securely engaged with the upper and lower body portions 202, 204.

Furthermore, in FIG. 18, a side view of the embodiment of the implant 200 in the expanded state illustrates the angular relationship of the proximal and distal wedge members 206, 208 and the upper and lower body portions 202, 204. As mentioned above, the dovetail shape of the slots and guide members ensures that for each given slot and guide member, a given wedge member is generally interlocked with the give slot to only provide one degree of freedom of movement of the guide member, and thus the wedge member, in the longitudinal direction of the given slot.

Accordingly, in such an embodiment, the wedge members 206, 208 may not be separable from the implant when the implant 200 is in the unexpanded state (as shown in FIG. 16A) due to the geometric constraints of the angular orientation of the slots and guide members with the actuator shaft inhibiting longitudinal relative movement of the wedge members 206, 208 relative to the upper and lower body portions 202, 204. Such a configuration ensures that the implant 200 is stable and structurally sound when in the unexpanded state or during expansion thereof, thus facilitating insertion and deployment of the implant 200.

Such an embodiment of the implant 200 can therefore be assembled by placing or engaging the wedge members 206, 208 with the actuator shaft 210, moving the wedge members 206, 208 axially together, and inserting the upper guide members 230, 232 into the slots 220 of the upper body portion 202 and the lower guide members 270, 272 into the slots 222 of the lower body portion 204. The wedge members 206, 208 can then be moved apart, which movement can cause the guide members and slots to engage and bring the upper and lower body portions toward each other. The implant 200 can then be prepared for insertion and deployment by reducing the implant 200 to the unexpanded state.

During assembly of the implant 200, the upper and lower body portions 202, 204 can be configured to snap together to limit expansion of the implant 200. For example, the upper and lower side portions 240, 242 can comprise upper and lower motion-limiting structures 280, 282, as shown in the cross-sectional view of FIG. 19. After the wedge members 206, 208 are engaged with the upper and lower body portions 202, 204 and axially separated to bring the upper and lower body portions 202, 204 together, the upper motion-limiting structure 280 can engage the lower motion-limiting structure 282. This engagement can occur due to deflection of at least one of the upper and lower side portions 240, 242. However, the motion-limiting structures 280, 282 preferably comprise interlocking lips or shoulders to engage one another when the implant 200 has reached maximum expansion. Accordingly, after the wedge members 206, 208 are assembled with the upper and lower body portions 202, 204, these components can be securely interconnected to thereby form a stable implant 200.

Referring again to FIG. 18, the implant 200 can define generally convex top and bottom surfaces 264, 262. This shape, as discussed above with respect to FIG. 14A, can be configured to generally match the concavity of adjacent vertebral bodies.

FIGS. 20A-B illustrate perspective views of the lower body portion 204 of the implant 200, according to an embodiment. These FIGS. provide additional clarity as to the configuration of the slots 222, the lower side portions 242, and the lower motion-limiting members 282 of the lower body portion 204. Similarly, FIGS. 21A-B illustrate perspective views of the upper body portion 202 of the implant 200, according to an embodiment. These FIGS. provide additional clarity as to the configuration of the slots 220, the upper side portions 240, and the upper motion-limiting members 280 of the upper body portion 202. Additionally, the upper and lower body portions 202, 204 can also define a central receptacle 290 wherein the actuator shaft can be received. Further, as mentioned above, the upper and lower body portions 202, 204 can define one or more apertures 252 to facilitate osseointegration.

FIG. 22 is a perspective view of an actuator shaft 210 of the implant 200 shown in FIG. 16A. In this embodiment, the actuator shaft 210 can be a single, continuous component having threads 294 disposed thereon for engaging the proximal and distal wedge members 206, 208. The threads can be configured to be left hand threads at a distal end of the actuator shaft 210 and right hand threads at a proximal other end of the actuator shaft for engaging the respective ones of the distal and proximal wedge members 208, 206. Accordingly, upon rotation of the actuator shaft 210, the wedge members 206, 208 can be caused to move toward or away from each other to facilitate expansion or contraction of the implant 200. Further, as noted above, although this embodiment is described and illustrated as having the actuator shaft 210 with threads 294, it is also contemplated that relative movement of the wedge members can be achieved through the use of the actuator shaft 30 described in reference to FIGS. 5-6, and that such an actuator shaft could likewise be used with the embodiment shown in FIGS. 16A-19.

In accordance with an embodiment, the actuator shaft 210 can also comprise a tool engagement section 296 and a proximal engagement section 298. The tool engagement section 296 can be configured as a to be engaged by a tool, as described further below. The tool engagement section 296 can be shaped as a polygon, such as a hex shape. As shown, the tool engagement section 296 is star shaped and includes six points, which configuration tends to facilitate the transfer of torque to the actuator shaft 210 from the tool. Other shapes and configurations can also be used.

Furthermore, the proximal engagement section 298 of the actuator shaft 210 can comprise a threaded aperture. The threaded aperture can be used to engage a portion of the tool for temporarily connecting the tool to the implant 200. It is also contemplated that the proximal engagement section 298 can also engage with the tool via a snap or press fit.

FIG. 23A-B illustrate perspective views of the proximal wedge member 206 of the implant 200. As described above, the proximal wedge member can include one or more anti-torque structures 250. Further, the guide members 230, 270 are also illustrated. The proximal wedge member 206 can comprise a central aperture 300 wherethrough an actuator shaft can be received. When actuator shaft 210 is used in an embodiment, the central aperture 300 can be threaded to correspond to the threads 294 of the actuator shaft 210. In other embodiments, the actuator shaft can engage other portions of the wedge member 206 for causing expansion or contraction thereof.

FIG. 24A-B illustrate perspective views of the distal wedge member 208 of the implant 200. As similarly discussed above with respect to the proximal wedge member 206, the guide members 232, 272 and a central aperture 302 of the proximal wedge member 206 are illustrated. The central aperture 302 can be configured to receive an actuator shaft therethrough. When actuator shaft 210 is used in an embodiment, the central aperture 302 can be threaded to correspond to the threads 294 of the actuator shaft 210. In other embodiments, the actuator shaft can engage other portions of the wedge member 208 for causing expansion or contraction thereof.

Referring now to FIG. 25, there is illustrated a perspective view of a deployment tool 400 according to another embodiment. The tool 400 can comprise a handle section 402 and a distal engagement section 404. The handle portion 402 can be configured to be held by a user and can comprise various features to facilitate implantation and deployment of the implant.

According to an embodiment, the handle section 402 can comprise a fixed portion 410, and one or more rotatable portions, such as the rotatable deployment portion 412 and the rotatable teathering portion 414. In such an embodiment, the teathering portion 414 can be used to attach the implant to the tool 400 prior to insertion and deployment. The deployment portion 412 can be used to actuate the implant and rotate the actuator shaft thereof for expanding the implant. Then, after the implant is expanded and properly placed, the teathering portion 414 can again be used to unteather or decouple the implant from the tool 400.

Further, the distal engagement section 404 can comprise a fixed portion 420, an anti-torque component 422, a teathering rod (element 424 shown in FIG. 26), and a shaft actuator rod (element 426 shown in FIG. 26) to facilitate engagement with and actuation of the implant 200. The anti-torque component 422 can be coupled to the fixed portion 420. As described above with reference to FIGS. 16A-B, in an embodiment, the implant 200 can comprise one or more anti-torque structures 250. The anti-torque component 422 can comprise one or more protrusions that engage the anti-torque structures 250 to prevent movement of the implant 200 when a rotational force is applied to the actuator shaft 210 via the tool 400. As illustrated, the anti-torque component 422 can comprise a pair of pins that extend from a distal end of the tool 400. However, it is contemplated that the implant 200 and tool 400 can be variously configured such that the anti-torque structures 250 and the anti-torque component 422 interconnect to prevent a torque being transferred to the implant 200. The generation of the rotational force will be explained in greater detail below with reference to FIG. 26, which is a side-cross sectional view of the tool 400 illustrating the interrelationship of the components of the handle section 402 and the distal engagement section 404.

For example, as illustrated in FIG. 26, the fixed portion 410 of the handle section 402 can be interconnected with the fixed portion 420 of the distal engagement section 404. The distal engagement section 404 can be configured with the deployment portion 412 being coupled with the shaft actuator rod 426 and the teathering portion 414 being coupled with the teathering rod 424. Although these portions can be coupled to each other respectively, they can move independently of each other and independently of the fixed portions. Thus, while holding the fixed portion 410 of the handle section 402, the deployment portion 412 and the teathering portion 414 can be moved to selectively expand or contract the implant or to attach the implant to the tool, respectively. In the illustrated embodiment, these portions 412, 414 can be rotated to cause rotation of an actuator shaft 210 of an implant 200 engaged with the tool 400.

As shown in FIG. 26, the teather rod 424 can comprise a distal engagement member 430 being configured to engage a proximal end of the actuator shaft 210 of the implant 200 for rotating the actuator shaft 210 to thereby expand the implant from an unexpanded state to and expanded state. The teather rod 424 can be configured with the distal engagement member 430 being a threaded distal section of the rod 424 that can be threadably coupled to an interior threaded portion of the actuator shaft 210.

In some embodiments, the tool 400 can be prepared for a single-use and can be packaged with an implant preloaded onto the tool 400. This arrangement can facilitate the use of the implant and also provide a sterile implant and tool for an operation. Thus, the tool 400 can be disposable after use in deploying the implant.

Referring again to FIG. 25, an embodiment of the tool 400 can also comprise an expansion indicator gauge 440 and a reset button 450. The expansion indicator gauge 440 can be configured to provide a visual indication corresponding to the expansion of the implant 200. For example, the gauge 440 can illustrate an exact height of the implant 200 as it is expanded or the amount of expansion. As shown in FIG. 26, the tool 400 can comprise a centrally disposed slider element 452 that can be in threaded engagement with a thread component 454 coupled to the deployment portion 412.

In an embodiment, the slider element 452 and an internal cavity 456 of the tool can be configured such that the slider element 452 is provided only translational movement in the longitudinal direction of the tool 400. Accordingly, as the deployment portion 412 is rotated, the thread component 454 is also rotated. In such an embodiment, as the thread component 454 rotates and is in engagement with the slider component 452, the slider element 452 can be incrementally moved from an initial position within the cavity 456 in response to the rotation of the deployment portion 412. An indicator 458 can thus be longitudinally moved and viewed to allow the gauge 440 to visually indicate the expansion and/or height of the implant 200. In such an embodiment, the gauge 440 can comprises a transparent window through which the indicator 458 on the slider element 452 can be seen. In the illustrated embodiment, the indicator 458 can be a marking on an exterior surface of the slider element 452.

In embodiments where the tool 400 can be reused, the reset button 450 can be utilized to zero out the gauge 440 to a pre-expansion setting. In such an embodiment, the slider element 452 can be spring-loaded, as shown with the spring 460 in FIG. 26. The reset button 450 can disengage the slider element 452 and the thread component 454 to allow the slider element 452 to be forced back to the initial position.

The specific dimensions of any of the embodiment disclosed herein can be readily varied depending upon the intended application, as will be apparent to those of skill in the art in view of the disclosure herein. Moreover, although the present inventions have been described in terms of certain preferred embodiments, other embodiments of the inventions including variations in the number of parts, dimensions, configuration and materials will be apparent to those of skill in the art in view of the disclosure herein. In addition, all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein to form various combinations and sub-combinations. The use of different terms or reference numerals for similar features in different embodiments does not imply differences other than those which may be expressly set forth. Accordingly, the present inventions are intended to be described solely by reference to the appended claims, and not limited to the preferred embodiments disclosed herein.

Claims

1. An adjustable spinal fusion intervertebral implant comprising: first and second body portions each having first and second surfaces at first and second ends thereof, respectively, the first surfaces of the first and second body portions generally facing each other, and the second surfaces of the first and second body portions generally facing each other, the first surface of each of the first and second body portions defining a respective first slot therein, and the second surface of each of the first and second body portions defining a respective second slot therein;a first wedge member disposed at the first ends of the first and second body portions, the first wedge member comprising guide members that extend at least partially into respective ones of the first slots of the first and second body portions with at least a portion of the first wedge member contacting the first surfaces of the first and second body portions;a second wedge member disposed at the second ends of the first and second body portions, the second wedge member comprising respective guide members that extend at least partially into respective ones of the second slots of the first and second body portions with at least a portion of the second wedge member contacting the second surfaces of the first and second body portions; andan actuator shaft received between the first and second body portions, the actuator shaft extending intermediate the first and second wedge members, wherein rotation of the actuator shaft causes the first and second wedge members to be drawn together such that longitudinal movement of the first wedge member against the first surfaces and longitudinal movement of the second wedge member against the second surfaces causes separation of the first and second body portions;wherein the first body portion further comprises a pair of side portions that extend toward the second body portion, the side portions each defining a groove, and the second body portion further comprises a pair of side portions that each include at least one rib that extends toward the first body portion, the at least one groove engaging the at least one rib to facilitate linear translational movement of the first body portion relative to the second body portion.
2. The adjustable spinal fusion intervertebral implant of claim 1, wherein the first and second surfaces of the first and second body portions are sloped.
3. The adjustable spinal fusion intervertebral implant of claim 2, wherein the slots of the first and second surfaces of the first and second body portions are sloped.
4. The adjustable spinal fusion intervertebral implant of claim 3, wherein the slots of the first and second surfaces of the first and second body portions are generally parallel to the respective first and second surfaces of the first and second body portions.
5. The adjustable spinal fusion intervertebral implant of claim 1, wherein the slots of the first and second surfaces of the first and second body portions are generally dove-tailed.
6. The adjustable spinal fusion intervertebral implant of claim 5, wherein the guide members of the first and second wedge members are generally dovetailed.
7. The adjustable spinal fusion intervertebral implant of claim 1, wherein the first and second body portions comprise generally arcuate respective first and second exterior engagement surfaces.
8. The adjustable spinal fusion intervertebral implant of claim 1, wherein the first wedge member comprises an anti-rotational element, the anti-rotational engagement being configured to be engaged by an implant tool for preventing rotation of the implant when the actuator shaft is rotated relative to the implant.
9. The adjustable spinal fusion intervertebral implant of claim 8, wherein the anti-rotational element comprises a pair of apertures extending into the first wedge member.
10. The adjustable spinal fusion intervertebral implant of claim 1, wherein the side portions of the first body portion each comprises an expansion limiting structure that engages with a complementary expansion limiting structure on each of the side portions of the second body portion so as to limit the linear translational movement of the first body portion relative to the second body portion.

PRIORITY INFORMATION

The present application is a divisional of U.S. application Ser. No. 13/845,644 filed Mar. 18, 2013, which is a continuation of U.S. application Ser. No. 13/334,526, filed Dec. 22, 2011 (now issued as U.S. Pat. No. 8,568,481), which is a continuation of U.S. application Ser. No. 11/952,900, filed Dec. 7, 2007 (now issued as U.S. Pat. No. 8,105,382), which claims the priority benefit of U.S. Provisional Application Ser. No. 60/869,088, filed Dec. 7, 2006. The entire contents of these applications are hereby incorporated by reference herein.

US Referenced Citations (1247)

Number	Name	Date	Kind
1802560	Kerwin	Apr 1931	A
1924695	Olson	Aug 1933	A
2077804	Morrison	Apr 1937	A
2121193	Hanicke	Jun 1938	A
2173655	Neracher et al.	Sep 1939	A
2243717	Moreira	May 1941	A
2381050	Hardinge	Aug 1945	A
2388056	Hendricks	Oct 1945	A
2485531	William et al.	Oct 1949	A
2489870	Dzus	Nov 1949	A
2570465	Lundholm	Oct 1951	A
2677369	Knowles	May 1954	A
3115804	Johnson	Dec 1963	A
3312139	Di Cristina	Apr 1967	A
3486505	Morrison	Dec 1969	A
3489143	Halloran	Jan 1970	A
3698391	Mahony	Oct 1972	A
3760802	Fischer et al.	Sep 1973	A
3805775	Fischer et al.	Apr 1974	A
3811449	Gravlee et al.	May 1974	A
3842825	Wagner	Oct 1974	A
3848601	Ma et al.	Nov 1974	A
3867728	Stubstad et al.	Feb 1975	A
3986504	Avila	Oct 1976	A
4013071	Rosenberg	Mar 1977	A
4052988	Doddi et al.	Oct 1977	A
4091806	Aginsky	May 1978	A
4175555	Herbert	Nov 1979	A
4236512	Aginsky	Dec 1980	A
4262665	Roalstad et al.	Apr 1981	A
4275717	Bolesky	Jun 1981	A
4312353	Shahbabian	Jan 1982	A
4341206	Perrett et al.	Jul 1982	A
4349921	Kuntz	Sep 1982	A
4350151	Scott	Sep 1982	A
4369790	McCarthy	Jan 1983	A
4401112	Rezaian	Aug 1983	A
4401433	Luther	Aug 1983	A
4409974	Freedland	Oct 1983	A
4449532	Storz	May 1984	A
4451256	Weikl et al.	May 1984	A
4456005	Lichty	Jun 1984	A
4463753	Gustilo	Aug 1984	A
4488543	Tornier	Dec 1984	A
4494535	Haig	Jan 1985	A
4532660	Field	Aug 1985	A
4537185	Stednitz	Aug 1985	A
4545374	Jacobson	Oct 1985	A
4573448	Kambin	Mar 1986	A
4601710	Moll	Jul 1986	A
4625725	Davison et al.	Dec 1986	A
4629450	Suzuki et al.	Dec 1986	A
4632101	Freedland	Dec 1986	A
4640271	Lower	Feb 1987	A
4641640	Griggs	Feb 1987	A
4653489	Tronzo	Mar 1987	A
4667663	Miyata	May 1987	A
4686984	Bonnet	Aug 1987	A
4688561	Reese	Aug 1987	A
4721103	Freedland	Jan 1988	A
4723544	Moore et al.	Feb 1988	A
4743257	Toermaelae et al.	May 1988	A
4759766	Buettner-Janz et al.	Jul 1988	A
4760843	Fischer et al.	Aug 1988	A
4790304	Rosenberg	Dec 1988	A
4790817	Luther	Dec 1988	A
4796612	Reese	Jan 1989	A
4802479	Haber et al.	Feb 1989	A
4815909	Simons	Mar 1989	A
4827917	Brumfield	May 1989	A
4858601	Glisson	Aug 1989	A
4862891	Smith	Sep 1989	A
4863476	Shepperd	Sep 1989	A
4873976	Schreiber	Oct 1989	A
4898186	Ikada et al.	Feb 1990	A
4903692	Reese	Feb 1990	A
4917554	Bronn	Apr 1990	A
4940467	Tronzo	Jul 1990	A
4959064	Engelhardt	Sep 1990	A
4963144	Huene	Oct 1990	A
4966587	Baumgart	Oct 1990	A
4968317	Toermaelae et al.	Nov 1990	A
4978334	Toye et al.	Dec 1990	A
4978349	Frigg	Dec 1990	A
4981482	Ichikawa	Jan 1991	A
4988351	Paulos et al.	Jan 1991	A
4994027	Farrell	Feb 1991	A
5002557	Hasson	Mar 1991	A
5011484	Breard	Apr 1991	A
5013315	Barrows	May 1991	A
5013316	Goble et al.	May 1991	A
5059193	Kuslich	Oct 1991	A
5062849	Schelhas	Nov 1991	A
5080662	Paul	Jan 1992	A
5084043	Hertzmann et al.	Jan 1992	A
5092891	Kummer et al.	Mar 1992	A
5098241	Aldridge et al.	Mar 1992	A
5098433	Freedland	Mar 1992	A
5098435	Stednitz et al.	Mar 1992	A
5114407	Burbank	May 1992	A
5116336	Frigg	May 1992	A
5120171	Lasner	Jun 1992	A
5122133	Evans	Jun 1992	A
5122141	Simpson et al.	Jun 1992	A
5123926	Pisharodi	Jun 1992	A
5139486	Moss	Aug 1992	A
5158543	Lazarus	Oct 1992	A
5167663	Brumfield	Dec 1992	A
5167664	Hodorek	Dec 1992	A
5169400	Muehling et al.	Dec 1992	A
5171278	Pisharodi	Dec 1992	A
5171279	Mathews	Dec 1992	A
5171280	Baumgartner	Dec 1992	A
5176651	Allgood et al.	Jan 1993	A
5176697	Hasson et al.	Jan 1993	A
5178501	Carstairs	Jan 1993	A
5183464	Dubrul et al.	Feb 1993	A
5188118	Terwilliger	Feb 1993	A
5195506	Hulfish	Mar 1993	A
5201742	Hasson	Apr 1993	A
5217462	Asnis et al.	Jun 1993	A
5217486	Rice et al.	Jun 1993	A
5224952	Deniega et al.	Jul 1993	A
5234431	Keller	Aug 1993	A
5241972	Bonati	Sep 1993	A
5242410	Melker	Sep 1993	A
5242447	Borzone	Sep 1993	A
5246441	Ross et al.	Sep 1993	A
5250049	Michael	Oct 1993	A
5269797	Bonati et al.	Dec 1993	A
5280782	Wilk	Jan 1994	A
5286001	Rafeld	Feb 1994	A
5290243	Chodorow et al.	Mar 1994	A
5290312	Kojimoto et al.	Mar 1994	A
5300074	Frigg	Apr 1994	A
5304142	Liebl et al.	Apr 1994	A
5308327	Heaven et al.	May 1994	A
5308352	Koutrouvelis	May 1994	A
5312410	Miller et al.	May 1994	A
5312417	Wilk	May 1994	A
5314477	Marnay	May 1994	A
5324261	Amundson et al.	Jun 1994	A
5334184	Bimman	Aug 1994	A
5334204	Clewett et al.	Aug 1994	A
5342365	Waldman	Aug 1994	A
5342382	Brinkerhoff et al.	Aug 1994	A
5344252	Kakimoto	Sep 1994	A
5364398	Chapman et al.	Nov 1994	A
5370646	Reese et al.	Dec 1994	A
5370647	Graber et al.	Dec 1994	A
5370661	Branch	Dec 1994	A
5370697	Baumgartner	Dec 1994	A
5382248	Jacobson et al.	Jan 1995	A
5387213	Breard et al.	Feb 1995	A
5387215	Fisher	Feb 1995	A
5390683	Pisharodi	Feb 1995	A
5395317	Kambin	Mar 1995	A
5395371	Miller et al.	Mar 1995	A
5401269	Buettner-Janz et al.	Mar 1995	A
5407430	Peters	Apr 1995	A
5415661	Holmes	May 1995	A
5424773	Saito	Jun 1995	A
5425773	Boyd et al.	Jun 1995	A
5443514	Steffee	Aug 1995	A
5449359	Groiso	Sep 1995	A
5449361	Preissman	Sep 1995	A
5452748	Simmons et al.	Sep 1995	A
5454790	Dubrul	Oct 1995	A
5464427	Curtis et al.	Nov 1995	A
5470333	Ray	Nov 1995	A
5472426	Bonati et al.	Dec 1995	A
5474539	Costa et al.	Dec 1995	A
5486190	Green	Jan 1996	A
5496318	Howland et al.	Mar 1996	A
5498265	Asnis et al.	Mar 1996	A
5501695	Anspach et al.	Mar 1996	A
5505710	Dorsey, III	Apr 1996	A
5507816	Bullivant	Apr 1996	A
5512037	Russell et al.	Apr 1996	A
5514180	Heggeness et al.	May 1996	A
5520690	Errico et al.	May 1996	A
5520896	De et al.	May 1996	A
5522899	Michelson	Jun 1996	A
5527312	Ray	Jun 1996	A
5534029	Shima	Jul 1996	A
5536127	Pennig	Jul 1996	A
5540688	Navas	Jul 1996	A
5540693	Fisher	Jul 1996	A
5545164	Howland	Aug 1996	A
5549610	Russell et al.	Aug 1996	A
5554191	Lahille et al.	Sep 1996	A
5556431	Buettner-Janz	Sep 1996	A
5558674	Heggeness et al.	Sep 1996	A
D374287	Goble et al.	Oct 1996	S
5562738	Boyd et al.	Oct 1996	A
5564926	Braanemark	Oct 1996	A
5569248	Mathews	Oct 1996	A
5569251	Baker et al.	Oct 1996	A
5569290	McAfee	Oct 1996	A
5569548	Koike et al.	Oct 1996	A
5591168	Judet et al.	Jan 1997	A
5609634	Voydeville	Mar 1997	A
5609635	Michelson	Mar 1997	A
5613950	Yoon	Mar 1997	A
5618142	Sonden et al.	Apr 1997	A
5618314	Harwin et al.	Apr 1997	A
5624447	Myers	Apr 1997	A
5626613	Schmieding	May 1997	A
5628751	Sander et al.	May 1997	A
5628752	Asnis et al.	May 1997	A
5639276	Weinstock et al.	Jun 1997	A
5643320	Lower et al.	Jul 1997	A
5645589	Li	Jul 1997	A
5645599	Samani	Jul 1997	A
5647857	Anderson et al.	Jul 1997	A
5649931	Bryant et al.	Jul 1997	A
5653763	Errico et al.	Aug 1997	A
5658335	Allen	Aug 1997	A
5662683	Kay	Sep 1997	A
5665095	Jacobson et al.	Sep 1997	A
5665122	Kambin	Sep 1997	A
5667508	Errico et al.	Sep 1997	A
5669915	Caspar et al.	Sep 1997	A
5676701	Yuan et al.	Oct 1997	A
5683465	Shinn et al.	Nov 1997	A
5693100	Pisharodi	Dec 1997	A
5697977	Pisharodi	Dec 1997	A
5702391	Lin	Dec 1997	A
5707359	Bufalini	Jan 1998	A
5713870	Yoon	Feb 1998	A
5713903	Sander et al.	Feb 1998	A
5716415	Steffee	Feb 1998	A
5716416	Lin	Feb 1998	A
5720753	Sander et al.	Feb 1998	A
5725541	Anspach et al.	Mar 1998	A
5725588	Errico et al.	Mar 1998	A
5728097	Mathews	Mar 1998	A
5728116	Rosenman	Mar 1998	A
5735853	Olerud	Apr 1998	A
5741282	Anspach et al.	Apr 1998	A
5743881	Demco	Apr 1998	A
5743912	Lahille et al.	Apr 1998	A
5743914	Skiba	Apr 1998	A
5749889	Bacich et al.	May 1998	A
5752969	Cunci et al.	May 1998	A
5762500	Lazarof	Jun 1998	A
5762629	Kambin	Jun 1998	A
5772661	Michelson	Jun 1998	A
5772662	Chapman et al.	Jun 1998	A
5772678	Thomason et al.	Jun 1998	A
5776156	Shikhman	Jul 1998	A
5782800	Yoon	Jul 1998	A
5782832	Larsen et al.	Jul 1998	A
5782865	Grotz	Jul 1998	A
5792044	Foley et al.	Aug 1998	A
5810721	Mueller et al.	Sep 1998	A
5810821	Vandewalle	Sep 1998	A
5810866	Yoon	Sep 1998	A
5814084	Grivas et al.	Sep 1998	A
5836948	Zucherman et al.	Nov 1998	A
5846259	Berthiaume	Dec 1998	A
5849004	Bramlet	Dec 1998	A
5851216	Allen	Dec 1998	A
5860973	Michelson	Jan 1999	A
5860977	Zucherman et al.	Jan 1999	A
5865848	Baker	Feb 1999	A
5871485	Rao et al.	Feb 1999	A
5873854	Wolvek	Feb 1999	A
5876404	Zucherman et al.	Mar 1999	A
5888223	Bray, Jr.	Mar 1999	A
5888224	Beckers et al.	Mar 1999	A
5888226	Rogozinski	Mar 1999	A
5888228	Knothe et al.	Mar 1999	A
5893850	Cachia	Apr 1999	A
5893889	Harrington	Apr 1999	A
5893890	Pisharodi	Apr 1999	A
5895428	Berry	Apr 1999	A
5902231	Foley et al.	May 1999	A
5904696	Rosenman	May 1999	A
5908422	Bresina	Jun 1999	A
5928235	Friedl	Jul 1999	A
5928244	Tovey et al.	Jul 1999	A
5928422	Uchiyama et al.	Jul 1999	A
5931870	Cuckler et al.	Aug 1999	A
5935129	McDevitt et al.	Aug 1999	A
5947999	Groiso	Sep 1999	A
5948000	Larsen et al.	Sep 1999	A
5954722	Bono	Sep 1999	A
5954747	Clark	Sep 1999	A
5957902	Teves	Sep 1999	A
5957924	Toermaelae et al.	Sep 1999	A
5964730	Williams et al.	Oct 1999	A
5964761	Kambin	Oct 1999	A
5967783	Ura	Oct 1999	A
5967970	Cowan et al.	Oct 1999	A
5968044	Nicholson et al.	Oct 1999	A
5968098	Winslow	Oct 1999	A
5976139	Bramlet	Nov 1999	A
5976146	Ogawa et al.	Nov 1999	A
5976186	Bao et al.	Nov 1999	A
5980522	Koros et al.	Nov 1999	A
5984927	Wenstrom et al.	Nov 1999	A
5984966	Kiema et al.	Nov 1999	A
5989255	Pepper et al.	Nov 1999	A
5989291	Ralph et al.	Nov 1999	A
5993459	Larsen et al.	Nov 1999	A
5997510	Schwemberger	Dec 1999	A
5997538	Asnis et al.	Dec 1999	A
5997541	Schenk	Dec 1999	A
6001100	Sherman et al.	Dec 1999	A
6001101	Augagneur et al.	Dec 1999	A
6004327	Asnis et al.	Dec 1999	A
6005161	Brekke	Dec 1999	A
6007519	Rosselli	Dec 1999	A
6007566	Wenstrom, Jr.	Dec 1999	A
6007580	Lehto et al.	Dec 1999	A
6010513	Toermaelae et al.	Jan 2000	A
6015410	Toermaelae et al.	Jan 2000	A
6019762	Cole	Feb 2000	A
6022352	Vandewalle	Feb 2000	A
6030162	Huebner	Feb 2000	A
6030364	Durgin et al.	Feb 2000	A
6033406	Mathews	Mar 2000	A
6036701	Rosenman	Mar 2000	A
6039761	Li et al.	Mar 2000	A
6039763	Shelokov	Mar 2000	A
6045579	Hochschuler et al.	Apr 2000	A
6048309	Flom et al.	Apr 2000	A
6048342	Zucherman et al.	Apr 2000	A
6053935	Brenneman et al.	Apr 2000	A
6066142	Serbousek et al.	May 2000	A
6068630	Zucherman et al.	May 2000	A
6068648	Cole et al.	May 2000	A
6074390	Zucherman et al.	Jun 2000	A
6080193	Hochschuler et al.	Jun 2000	A
6083244	Lubbers et al.	Jul 2000	A
6090112	Zucherman et al.	Jul 2000	A
6099531	Bonutti	Aug 2000	A
6102914	Bulstra et al.	Aug 2000	A
6102950	Vaccaro	Aug 2000	A
6106557	Robioneck et al.	Aug 2000	A
6113637	Gill et al.	Sep 2000	A
6113638	Williams et al.	Sep 2000	A
6117174	Nolan	Sep 2000	A
6123711	Winters	Sep 2000	A
6126661	Faccioli et al.	Oct 2000	A
6126663	Hair	Oct 2000	A
6127597	Beyar et al.	Oct 2000	A
6129762	Li	Oct 2000	A
6129763	Chauvin et al.	Oct 2000	A
6146384	Lee et al.	Nov 2000	A
6146387	Trott et al.	Nov 2000	A
6149652	Zucherman et al.	Nov 2000	A
6152926	Zucherman et al.	Nov 2000	A
6156038	Zucherman et al.	Dec 2000	A
6159179	Simonson	Dec 2000	A
6161350	Espinosa	Dec 2000	A
6162234	Freedland et al.	Dec 2000	A
6162236	Osada	Dec 2000	A
6168595	Durham et al.	Jan 2001	B1
6168597	Biedermann et al.	Jan 2001	B1
6175758	Kambin	Jan 2001	B1
6176882	Biedermann et al.	Jan 2001	B1
6179794	Burras	Jan 2001	B1
6179873	Zientek	Jan 2001	B1
6183471	Zucherman et al.	Feb 2001	B1
6183472	Lutz	Feb 2001	B1
6183474	Bramlet et al.	Feb 2001	B1
6183517	Suddaby	Feb 2001	B1
6190387	Zucherman et al.	Feb 2001	B1
6193757	Foley et al.	Feb 2001	B1
6197041	Shichman et al.	Mar 2001	B1
6200322	Branch et al.	Mar 2001	B1
6206826	Mathews et al.	Mar 2001	B1
6206922	Zdeblick et al.	Mar 2001	B1
6213957	Milliman et al.	Apr 2001	B1
6217509	Foley et al.	Apr 2001	B1
6221082	Marino et al.	Apr 2001	B1
6228058	Dennis et al.	May 2001	B1
6231606	Graf et al.	May 2001	B1
6235030	Zucherman et al.	May 2001	B1
6238397	Zucherman et al.	May 2001	B1
6245107	Ferree	Jun 2001	B1
6248108	Toermaelae et al.	Jun 2001	B1
6251111	Barker et al.	Jun 2001	B1
6264676	Gellman et al.	Jul 2001	B1
6267765	Taylor et al.	Jul 2001	B1
6267767	Strobel et al.	Jul 2001	B1
6280444	Zucherman et al.	Aug 2001	B1
6287313	Sasso	Sep 2001	B1
6293909	Chu et al.	Sep 2001	B1
6293952	Brosens et al.	Sep 2001	B1
6296647	Robioneck et al.	Oct 2001	B1
6302914	Michelson	Oct 2001	B1
6306136	Baccelli	Oct 2001	B1
6319254	Giet et al.	Nov 2001	B1
6319272	Brenneman et al.	Nov 2001	B1
6332882	Zucherman et al.	Dec 2001	B1
6332883	Zucherman et al.	Dec 2001	B1
6332895	Suddaby	Dec 2001	B1
6346092	Leschinsky	Feb 2002	B1
6348053	Cachia	Feb 2002	B1
6355043	Adam	Mar 2002	B1
6361537	Anderson	Mar 2002	B1
6361538	Fenaroli et al.	Mar 2002	B1
6361557	Gittings et al.	Mar 2002	B1
6364897	Bonutti	Apr 2002	B1
6368350	Erickson et al.	Apr 2002	B1
6368351	Glenn et al.	Apr 2002	B1
6371971	Tsugita et al.	Apr 2002	B1
6371989	Chauvin et al.	Apr 2002	B1
6375682	Fleischmann et al.	Apr 2002	B1
6379355	Zucherman et al.	Apr 2002	B1
6379363	Herrington et al.	Apr 2002	B1
6387130	Stone et al.	May 2002	B1
6409766	Brett	Jun 2002	B1
6409767	Perice et al.	Jun 2002	B1
6419676	Zucherman et al.	Jul 2002	B1
6419677	Zucherman et al.	Jul 2002	B2
6419704	Ferree	Jul 2002	B1
6419705	Erickson	Jul 2002	B1
6419706	Graf	Jul 2002	B1
6423061	Bryant	Jul 2002	B1
6423067	Eisermann	Jul 2002	B1
6425919	Lambrecht	Jul 2002	B1
6428541	Boyd et al.	Aug 2002	B1
6428556	Chin	Aug 2002	B1
6436140	Liu et al.	Aug 2002	B1
6436143	Ross et al.	Aug 2002	B1
6440154	Gellman et al.	Aug 2002	B2
6440169	Elberg et al.	Aug 2002	B1
6443989	Jackson	Sep 2002	B1
6447527	Thompson et al.	Sep 2002	B1
6447540	Fontaine et al.	Sep 2002	B1
6450989	Dubrul et al.	Sep 2002	B2
6451019	Zucherman et al.	Sep 2002	B1
6451020	Zucherman et al.	Sep 2002	B1
6454806	Cohen et al.	Sep 2002	B1
6454807	Jackson	Sep 2002	B1
6458134	Songer et al.	Oct 2002	B1
6468277	Justin et al.	Oct 2002	B1
6468309	Lieberman	Oct 2002	B1
6468310	Ralph et al.	Oct 2002	B1
6471724	Zdeblick et al.	Oct 2002	B2
6475226	Belef et al.	Nov 2002	B1
6478029	Boyd et al.	Nov 2002	B1
6478796	Zucherman et al.	Nov 2002	B2
6485491	Farris et al.	Nov 2002	B1
6485518	Cornwall et al.	Nov 2002	B1
6488693	Gannoe et al.	Dec 2002	B2
6488710	Besselink	Dec 2002	B2
6489309	Singh et al.	Dec 2002	B1
6491714	Bennett	Dec 2002	B1
6494860	Rocamora et al.	Dec 2002	B2
6494893	Dubrul et al.	Dec 2002	B2
6500178	Zucherman et al.	Dec 2002	B2
6506192	Gertzman et al.	Jan 2003	B1
6511481	Von et al.	Jan 2003	B2
6514256	Zucherman et al.	Feb 2003	B2
6517543	Berrevoets et al.	Feb 2003	B1
6517580	Ramadan et al.	Feb 2003	B1
6520907	Foley et al.	Feb 2003	B1
6527774	Lieberman	Mar 2003	B2
6527803	Crozet et al.	Mar 2003	B1
6527804	Gauchet et al.	Mar 2003	B1
6540747	Marino	Apr 2003	B1
6544265	Lieberman	Apr 2003	B2
6547793	McGuire	Apr 2003	B1
6547795	Schneiderman	Apr 2003	B2
6551319	Lieberman	Apr 2003	B2
6551322	Lieberman	Apr 2003	B1
6554831	Rivard et al.	Apr 2003	B1
6554852	Oberlander	Apr 2003	B1
6558389	Clark et al.	May 2003	B2
6558424	Thalgott	May 2003	B2
6562046	Sasso	May 2003	B2
6562049	Norlander et al.	May 2003	B1
6562074	Gerbec et al.	May 2003	B2
6575979	Cragg	Jun 2003	B1
6576016	Hochshuler et al.	Jun 2003	B1
6579293	Chandran	Jun 2003	B1
6582390	Sanderson	Jun 2003	B1
6582431	Ray	Jun 2003	B1
6582433	Yun	Jun 2003	B2
6582437	Dorchak et al.	Jun 2003	B2
6582441	He et al.	Jun 2003	B1
6582453	Tran et al.	Jun 2003	B1
6582468	Gauchet	Jun 2003	B1
6585730	Foerster	Jul 2003	B1
6585740	Schlapfer et al.	Jul 2003	B2
6589240	Hinchliffe	Jul 2003	B2
6589249	Sater et al.	Jul 2003	B2
6592553	Zhang et al.	Jul 2003	B2
6595998	Johnson et al.	Jul 2003	B2
6596008	Kambin	Jul 2003	B1
6599297	Carlsson et al.	Jul 2003	B1
6607530	Carl et al.	Aug 2003	B1
6610091	Reiley	Aug 2003	B1
6610094	Husson	Aug 2003	B2
6613050	Wagner et al.	Sep 2003	B1
6616678	Nishtala et al.	Sep 2003	B2
6620196	Trieu	Sep 2003	B1
6626944	Taylor	Sep 2003	B1
6632224	Cachia et al.	Oct 2003	B2
6635059	Randall et al.	Oct 2003	B2
6635362	Zheng	Oct 2003	B2
6641564	Kraus	Nov 2003	B1
6641614	Wagner et al.	Nov 2003	B1
6645248	Casutt	Nov 2003	B2
6648890	Culbert et al.	Nov 2003	B2
6648893	Dudasik	Nov 2003	B2
6648917	Gerbec et al.	Nov 2003	B2
6652527	Zucherman et al.	Nov 2003	B2
6655962	Kennard	Dec 2003	B1
6666891	Boehm et al.	Dec 2003	B2
6669698	Tromanhauser et al.	Dec 2003	B1
6669729	Chin	Dec 2003	B2
6673074	Shluzas	Jan 2004	B2
6676664	Al-Assir	Jan 2004	B1
6676665	Foley et al.	Jan 2004	B2
6679833	Smith et al.	Jan 2004	B2
6682535	Hoogland	Jan 2004	B2
6685706	Padget et al.	Feb 2004	B2
6685742	Jackson	Feb 2004	B1
6689152	Balceta et al.	Feb 2004	B2
6692499	Toermaelae et al.	Feb 2004	B2
6695842	Zucherman et al.	Feb 2004	B2
6695851	Zdeblick et al.	Feb 2004	B2
6699246	Zucherman et al.	Mar 2004	B2
6699247	Zucherman et al.	Mar 2004	B2
6706070	Wagner et al.	Mar 2004	B1
6712819	Zucherman et al.	Mar 2004	B2
6716247	Michelson	Apr 2004	B2
6719760	Dorchak et al.	Apr 2004	B2
6719796	Cohen et al.	Apr 2004	B2
6723096	Dorchak et al.	Apr 2004	B1
6723126	Berry	Apr 2004	B1
6730126	Boehm et al.	May 2004	B2
6733093	Deland et al.	May 2004	B2
6733460	Ogura	May 2004	B2
6733532	Gauchet et al.	May 2004	B1
6733534	Sherman	May 2004	B2
6733535	Michelson	May 2004	B2
6733635	Ozawa et al.	May 2004	B1
6740090	Cragg et al.	May 2004	B1
6740093	Hochschuler et al.	May 2004	B2
6740117	Ralph et al.	May 2004	B2
6743166	Berci et al.	Jun 2004	B2
6743255	Ferree	Jun 2004	B2
6746451	Middleton et al.	Jun 2004	B2
6752831	Sybert et al.	Jun 2004	B2
6761720	Senegas	Jul 2004	B1
6770075	Howland	Aug 2004	B2
6773460	Jackson	Aug 2004	B2
6790210	Cragg et al.	Sep 2004	B1
6793656	Mathews	Sep 2004	B1
6793678	Hawkins	Sep 2004	B2
6796983	Zucherman et al.	Sep 2004	B1
6805685	Taylor	Oct 2004	B2
6805695	Keith et al.	Oct 2004	B2
6805714	Sutcliffe	Oct 2004	B2
6808526	Magerl et al.	Oct 2004	B1
6808537	Michelson	Oct 2004	B2
6821298	Jackson	Nov 2004	B1
6830589	Erickson	Dec 2004	B2
6835205	Atkinson et al.	Dec 2004	B2
6835206	Jackson	Dec 2004	B2
6852129	Gerbec et al.	Feb 2005	B2
6855167	Shimp et al.	Feb 2005	B2
6863673	Gerbec et al.	Mar 2005	B2
6875215	Taras et al.	Apr 2005	B2
6881229	Khandkar et al.	Apr 2005	B2
6887243	Culbert	May 2005	B2
6890333	Von et al.	May 2005	B2
6893464	Kiester	May 2005	B2
6893466	Trieu	May 2005	B2
6902566	Zucherman et al.	Jun 2005	B2
6908465	Von et al.	Jun 2005	B2
6916323	Kitchens	Jul 2005	B2
6921403	Cragg et al.	Jul 2005	B2
6923811	Carl et al.	Aug 2005	B1
6929606	Ritland	Aug 2005	B2
6936071	Marnay et al.	Aug 2005	B1
6936072	Lambrecht et al.	Aug 2005	B2
6942668	Padget et al.	Sep 2005	B2
6945975	Dalton	Sep 2005	B2
6946000	Senegas et al.	Sep 2005	B2
6949100	Venturini	Sep 2005	B1
6951561	Warren et al.	Oct 2005	B2
6953477	Berry	Oct 2005	B2
6955691	Chae et al.	Oct 2005	B2
6969404	Ferree	Nov 2005	B2
6969405	Suddaby	Nov 2005	B2
6972035	Michelson	Dec 2005	B2
6997929	Manzi et al.	Feb 2006	B2
7004945	Boyd et al.	Feb 2006	B2
7018412	Ferreira et al.	Mar 2006	B2
7018415	McKay	Mar 2006	B1
7018416	Hanson et al.	Mar 2006	B2
7025746	Tal	Apr 2006	B2
7029473	Zucherman et al.	Apr 2006	B2
7037339	Houfburg	May 2006	B2
7041107	Pohjonen et al.	May 2006	B2
7048736	Robinson et al.	May 2006	B2
7060068	Tromanhauser et al.	Jun 2006	B2
7063701	Michelson	Jun 2006	B2
7063702	Michelson	Jun 2006	B2
7066960	Dickman	Jun 2006	B1
7066961	Michelson	Jun 2006	B2
7070601	Culbert et al.	Jul 2006	B2
7074203	Johanson et al.	Jul 2006	B1
7083650	Moskowitz et al.	Aug 2006	B2
7087083	Pasquet et al.	Aug 2006	B2
7094239	Michelson	Aug 2006	B1
7094257	Mujwid et al.	Aug 2006	B2
7094258	Lambrecht et al.	Aug 2006	B2
7101375	Zucherman et al.	Sep 2006	B2
7114501	Johnson et al.	Oct 2006	B2
7118572	Bramlet et al.	Oct 2006	B2
7118579	Michelson	Oct 2006	B2
7118598	Michelson	Oct 2006	B2
7128760	Michelson	Oct 2006	B2
7153305	Johnson et al.	Dec 2006	B2
D536096	Hoogland et al.	Jan 2007	S
7156876	Moumene et al.	Jan 2007	B2
7163558	Senegas et al.	Jan 2007	B2
7172612	Ishikawa	Feb 2007	B2
7179294	Eisermann et al.	Feb 2007	B2
7201751	Zucherman et al.	Apr 2007	B2
7211112	Baynham et al.	May 2007	B2
7217293	Branch, Jr.	May 2007	B2
7220280	Kast et al.	May 2007	B2
7223292	Messerli et al.	May 2007	B2
7226481	Kuslich	Jun 2007	B2
7226483	Gerber et al.	Jun 2007	B2
7235101	Berry et al.	Jun 2007	B2
7238204	Le et al.	Jul 2007	B2
7267683	Sharkey et al.	Sep 2007	B2
7282061	Sharkey et al.	Oct 2007	B2
7306628	Zucherman et al.	Dec 2007	B2
7309357	Kim	Dec 2007	B2
7326211	Padget et al.	Feb 2008	B2
7326248	Michelson	Feb 2008	B2
7335203	Winslow et al.	Feb 2008	B2
7361140	Ries et al.	Apr 2008	B2
7371238	Soboleski et al.	May 2008	B2
7377942	Berry	May 2008	B2
7400930	Sharkey et al.	Jul 2008	B2
7410501	Michelson	Aug 2008	B2
7413576	Sybert et al.	Aug 2008	B2
7422594	Zander	Sep 2008	B2
7434325	Foley et al.	Oct 2008	B2
7445636	Michelson	Nov 2008	B2
7445637	Taylor	Nov 2008	B2
D584812	Ries	Jan 2009	S
7473256	Assell et al.	Jan 2009	B2
7473268	Zucherman et al.	Jan 2009	B2
7476251	Zucherman et al.	Jan 2009	B2
7488326	Elliott	Feb 2009	B2
7503933	Michelson	Mar 2009	B2
7507241	Levy et al.	Mar 2009	B2
7517363	Rogers et al.	Apr 2009	B2
7520888	Trieu	Apr 2009	B2
7547317	Cragg	Jun 2009	B2
7556629	Von et al.	Jul 2009	B2
7556651	Humphreys et al.	Jul 2009	B2
7569074	Eisermann et al.	Aug 2009	B2
7588574	Assell et al.	Sep 2009	B2
7618458	Biedermann et al.	Nov 2009	B2
7621950	Globerman et al.	Nov 2009	B1
7621960	Boyd et al.	Nov 2009	B2
7625378	Foley	Dec 2009	B2
7641657	Cragg	Jan 2010	B2
7641670	Davison et al.	Jan 2010	B2
7647123	Sharkey et al.	Jan 2010	B2
7648523	Mirkovic et al.	Jan 2010	B2
7670354	Davison et al.	Mar 2010	B2
7674273	Davison et al.	Mar 2010	B2
7682370	Pagliuca et al.	Mar 2010	B2
7691120	Shluzas et al.	Apr 2010	B2
7691147	Guetlin et al.	Apr 2010	B2
7699878	Pavlov et al.	Apr 2010	B2
7703727	Selness	Apr 2010	B2
7717944	Foley et al.	May 2010	B2
7722530	Davison	May 2010	B2
7722612	Sala et al.	May 2010	B2
7722674	Grotz	May 2010	B1
7727263	Cragg	Jun 2010	B2
7740633	Assell et al.	Jun 2010	B2
7744599	Cragg	Jun 2010	B2
7749270	Peterman	Jul 2010	B2
7762995	Eversull et al.	Jul 2010	B2
7763025	Ainsworth	Jul 2010	B2
7763055	Foley	Jul 2010	B2
7766930	DiPoto et al.	Aug 2010	B2
7771473	Thramann	Aug 2010	B2
7771479	Humphreys et al.	Aug 2010	B2
7785368	Schaller	Aug 2010	B2
7789914	Michelson	Sep 2010	B2
7794463	Cragg	Sep 2010	B2
7799032	Assell et al.	Sep 2010	B2
7799033	Assell et al.	Sep 2010	B2
7799036	Davison et al.	Sep 2010	B2
D626233	Cipoletti et al.	Oct 2010	S
7814429	Buffet et al.	Oct 2010	B2
7819921	Grotz	Oct 2010	B2
7824410	Simonson et al.	Nov 2010	B2
7824429	Culbert et al.	Nov 2010	B2
7824445	Biro et al.	Nov 2010	B2
7837734	Zucherman et al.	Nov 2010	B2
7846183	Blain	Dec 2010	B2
7846206	Oglaza et al.	Dec 2010	B2
7850695	Pagliuca et al.	Dec 2010	B2
7850733	Baynham et al.	Dec 2010	B2
7854766	Moskowitz et al.	Dec 2010	B2
7857832	Culbert et al.	Dec 2010	B2
7862590	Lim et al.	Jan 2011	B2
7862595	Foley et al.	Jan 2011	B2
7867259	Foley et al.	Jan 2011	B2
7874980	Sonnenschein et al.	Jan 2011	B2
7875077	Humphreys et al.	Jan 2011	B2
7879098	Simmons, Jr.	Feb 2011	B1
7887589	Glenn et al.	Feb 2011	B2
7892171	Davison et al.	Feb 2011	B2
7892249	Davison et al.	Feb 2011	B2
7901438	Culbert et al.	Mar 2011	B2
7901459	Hodges et al.	Mar 2011	B2
7909870	Kraus	Mar 2011	B2
7922729	Michelson	Apr 2011	B2
7931689	Hochschuler et al.	Apr 2011	B2
7938832	Culbert et al.	May 2011	B2
7951199	Miller	May 2011	B2
7985231	Sankaran	Jul 2011	B2
7993403	Foley et al.	Aug 2011	B2
7998176	Culbert	Aug 2011	B2
8021424	Beger et al.	Sep 2011	B2
8021426	Segal et al.	Sep 2011	B2
8025697	McClellan et al.	Sep 2011	B2
8034109	Zwirkoski	Oct 2011	B2
8043381	Hestad et al.	Oct 2011	B2
8062375	Glerum et al.	Nov 2011	B2
8075621	Michelson	Dec 2011	B2
8105382	Olmos	Jan 2012	B2
8109977	Culbert et al.	Feb 2012	B2
8118871	Gordon	Feb 2012	B2
8133232	Levy et al.	Mar 2012	B2
8177812	Sankaran	May 2012	B2
8192495	Simpson et al.	Jun 2012	B2
8221501	Eisermann et al.	Jul 2012	B2
8221502	Branch, Jr.	Jul 2012	B2
8231681	Castleman et al.	Jul 2012	B2
8236058	Fabian et al.	Aug 2012	B2
8241358	Butler et al.	Aug 2012	B2
8257440	Gordon et al.	Sep 2012	B2
8257442	Edie et al.	Sep 2012	B2
8262666	Baynham et al.	Sep 2012	B2
8262736	Michelson	Sep 2012	B2
8267939	Cipoletti et al.	Sep 2012	B2
8273128	Oh et al.	Sep 2012	B2
8273129	Baynham et al.	Sep 2012	B2
8287599	McGuckin, Jr.	Oct 2012	B2
8303663	Jimenez et al.	Nov 2012	B2
8317866	Palmatier et al.	Nov 2012	B2
8323345	Sledge	Dec 2012	B2
8328852	Zehavi et al.	Dec 2012	B2
8337559	Hansell et al.	Dec 2012	B2
8353961	McClintock et al.	Jan 2013	B2
8366777	Matthis et al.	Feb 2013	B2
8382842	Greenhalgh et al.	Feb 2013	B2
8394129	Morgenstern et al.	Mar 2013	B2
8398713	Weiman	Mar 2013	B2
8403990	Dryer et al.	Mar 2013	B2
8409291	Blackwell et al.	Apr 2013	B2
8435298	Weiman	May 2013	B2
8454617	Schaller et al.	Jun 2013	B2
8486148	Butler et al.	Jul 2013	B2
8491657	Attia et al.	Jul 2013	B2
8491659	Weiman	Jul 2013	B2
8506635	Palmatier et al.	Aug 2013	B2
8518087	Lopez et al.	Aug 2013	B2
8518120	Glerum et al.	Aug 2013	B2
8551173	Lechmann et al.	Oct 2013	B2
8556979	Glerum et al.	Oct 2013	B2
8568481	Olmos et al.	Oct 2013	B2
8579977	Fabian	Nov 2013	B2
8579981	Lim et al.	Nov 2013	B2
8591585	McLaughlin et al.	Nov 2013	B2
8597333	Morgenstern et al.	Dec 2013	B2
8603170	Cipoletti et al.	Dec 2013	B2
8628576	Triplett et al.	Jan 2014	B2
8628578	Miller et al.	Jan 2014	B2
8632595	Weiman	Jan 2014	B2
8663329	Ernst	Mar 2014	B2
8668740	Rhoda et al.	Mar 2014	B2
8679183	Glerum et al.	Mar 2014	B2
8685098	Glerum et al.	Apr 2014	B2
8696751	Ashley et al.	Apr 2014	B2
8709086	Glerum	Apr 2014	B2
8715351	Pinto	May 2014	B1
8721723	Hansell et al.	May 2014	B2
8728160	Globerman et al.	May 2014	B2
8753398	Gordon et al.	Jun 2014	B2
8771360	Jimenez et al.	Jul 2014	B2
8778025	Ragab et al.	Jul 2014	B2
8795366	Varela	Aug 2014	B2
8828085	Jensen	Sep 2014	B1
8845731	Weiman	Sep 2014	B2
8845732	Weiman	Sep 2014	B2
8845734	Weiman	Sep 2014	B2
8852242	Morgenstern et al.	Oct 2014	B2
8852243	Morgenstern et al.	Oct 2014	B2
8852279	Weiman	Oct 2014	B2
8864833	Glerum et al.	Oct 2014	B2
8888853	Glerum et al.	Nov 2014	B2
8888854	Glerum et al.	Nov 2014	B2
8900307	Hawkins et al.	Dec 2014	B2
8936641	Cain	Jan 2015	B2
8940052	Lechmann et al.	Jan 2015	B2
9095446	Landry et al.	Aug 2015	B2
9095447	Barreiro et al.	Aug 2015	B2
9277928	Morgenstern Lopez	Mar 2016	B2
9402739	Weiman et al.	Aug 2016	B2
9433510	Lechmann et al.	Sep 2016	B2
9597197	Lechmann et al.	Mar 2017	B2
20010012950	Nishtala et al.	Aug 2001	A1
20010027320	Sasso	Oct 2001	A1
20010037126	Stack et al.	Nov 2001	A1
20010039452	Zucherman et al.	Nov 2001	A1
20010049529	Cachia et al.	Dec 2001	A1
20010049530	Culbert et al.	Dec 2001	A1
20020001476	Nagamine et al.	Jan 2002	A1
20020010070	Cales et al.	Jan 2002	A1
20020032462	Houser et al.	Mar 2002	A1
20020055740	Lieberman	May 2002	A1
20020068976	Jackson	Jun 2002	A1
20020068977	Jackson	Jun 2002	A1
20020087152	Mikus et al.	Jul 2002	A1
20020091387	Hoogland	Jul 2002	A1
20020120335	Angelucci et al.	Aug 2002	A1
20020128715	Bryan et al.	Sep 2002	A1
20020128716	Cohen et al.	Sep 2002	A1
20020138146	Jackson	Sep 2002	A1
20020143331	Zucherman et al.	Oct 2002	A1
20020143334	Hoffmann et al.	Oct 2002	A1
20020143335	Von et al.	Oct 2002	A1
20020151895	Soboleski et al.	Oct 2002	A1
20020151976	Foley et al.	Oct 2002	A1
20020161444	Choi	Oct 2002	A1
20020165612	Gerber et al.	Nov 2002	A1
20020183848	Ray et al.	Dec 2002	A1
20030004575	Erickson	Jan 2003	A1
20030004576	Thalgott	Jan 2003	A1
20030023305	McKay	Jan 2003	A1
20030028250	Reiley et al.	Feb 2003	A1
20030040799	Boyd et al.	Feb 2003	A1
20030063582	Mizell et al.	Apr 2003	A1
20030065330	Zucherman et al.	Apr 2003	A1
20030065396	Michelson	Apr 2003	A1
20030069582	Culbert	Apr 2003	A1
20030078667	Manasas et al.	Apr 2003	A1
20030083688	Simonson	May 2003	A1
20030130739	Gerbec et al.	Jul 2003	A1
20030135275	Garcia et al.	Jul 2003	A1
20030139648	Foley et al.	Jul 2003	A1
20030139812	Garcia et al.	Jul 2003	A1
20030139813	Messerli et al.	Jul 2003	A1
20030153874	Tal	Aug 2003	A1
20030187431	Simonson	Oct 2003	A1
20030208122	Melkent et al.	Nov 2003	A1
20030208220	Worley et al.	Nov 2003	A1
20030220643	Ferree	Nov 2003	A1
20030229350	Kay	Dec 2003	A1
20030233102	Nakamura et al.	Dec 2003	A1
20030233145	Landry et al.	Dec 2003	A1
20040006391	Reiley	Jan 2004	A1
20040008949	Liu et al.	Jan 2004	A1
20040019359	Worley et al.	Jan 2004	A1
20040024463	Thomas et al.	Feb 2004	A1
20040030387	Landry et al.	Feb 2004	A1
20040049190	Biedermann et al.	Mar 2004	A1
20040049223	Nishtala et al.	Mar 2004	A1
20040054412	Gerbec et al.	Mar 2004	A1
20040059339	Roehm et al.	Mar 2004	A1
20040059350	Gordon et al.	Mar 2004	A1
20040064144	Johnson et al.	Apr 2004	A1
20040087947	Lim et al.	May 2004	A1
20040088055	Hanson et al.	May 2004	A1
20040093083	Branch et al.	May 2004	A1
20040097924	Lambrecht et al.	May 2004	A1
20040097941	Weiner et al.	May 2004	A1
20040097973	Loshakove et al.	May 2004	A1
20040106925	Culbert	Jun 2004	A1
20040127906	Culbert et al.	Jul 2004	A1
20040127991	Ferree	Jul 2004	A1
20040133280	Trieu	Jul 2004	A1
20040143284	Chin	Jul 2004	A1
20040143734	Buer et al.	Jul 2004	A1
20040147877	Heuser	Jul 2004	A1
20040147950	Mueller et al.	Jul 2004	A1
20040148027	Errico et al.	Jul 2004	A1
20040153065	Lim	Aug 2004	A1
20040153156	Cohen	Aug 2004	A1
20040153160	Carrasco	Aug 2004	A1
20040158258	Bonati et al.	Aug 2004	A1
20040162617	Zucherman et al.	Aug 2004	A1
20040162618	Mujwid et al.	Aug 2004	A1
20040172133	Gerber et al.	Sep 2004	A1
20040172134	Berry	Sep 2004	A1
20040186471	Trieu	Sep 2004	A1
20040186482	Kolb et al.	Sep 2004	A1
20040186570	Rapp	Sep 2004	A1
20040186577	Ferree	Sep 2004	A1
20040199162	Von et al.	Oct 2004	A1
20040215343	Hochschuler et al.	Oct 2004	A1
20040215344	Hochschuler et al.	Oct 2004	A1
20040220580	Johnson et al.	Nov 2004	A1
20040225292	Sasso et al.	Nov 2004	A1
20040225361	Glenn et al.	Nov 2004	A1
20040230309	DiMauro et al.	Nov 2004	A1
20040243239	Taylor	Dec 2004	A1
20040249466	Liu et al.	Dec 2004	A1
20040254575	Obenchain et al.	Dec 2004	A1
20040260297	Padget et al.	Dec 2004	A1
20040266257	Ries et al.	Dec 2004	A1
20050010292	Carrasco	Jan 2005	A1
20050033289	Warren et al.	Feb 2005	A1
20050033434	Berry	Feb 2005	A1
20050038515	Kunzler	Feb 2005	A1
20050043796	Grant et al.	Feb 2005	A1
20050065610	Pisharodi	Mar 2005	A1
20050090443	Michael	Apr 2005	A1
20050090833	DiPoto	Apr 2005	A1
20050102202	Linden et al.	May 2005	A1
20050113916	Branch, Jr.	May 2005	A1
20050113917	Chae et al.	May 2005	A1
20050113927	Malek	May 2005	A1
20050118550	Turri	Jun 2005	A1
20050119657	Goldsmith	Jun 2005	A1
20050125062	Biedermann et al.	Jun 2005	A1
20050130929	Boyd	Jun 2005	A1
20050131406	Reiley et al.	Jun 2005	A1
20050131409	Chervitz et al.	Jun 2005	A1
20050131411	Culbert	Jun 2005	A1
20050131538	Chervitz et al.	Jun 2005	A1
20050137595	Hoffmann et al.	Jun 2005	A1
20050143734	Cachia et al.	Jun 2005	A1
20050149030	Serhan et al.	Jul 2005	A1
20050154467	Peterman et al.	Jul 2005	A1
20050165398	Reiley	Jul 2005	A1
20050165485	Trieu	Jul 2005	A1
20050171552	Johnson et al.	Aug 2005	A1
20050171608	Peterman et al.	Aug 2005	A1
20050171610	Humphreys et al.	Aug 2005	A1
20050177235	Baynham et al.	Aug 2005	A1
20050177240	Blain	Aug 2005	A1
20050182414	Manzi et al.	Aug 2005	A1
20050182418	Boyd et al.	Aug 2005	A1
20050187558	Johnson et al.	Aug 2005	A1
20050187559	Raymond et al.	Aug 2005	A1
20050203512	Hawkins et al.	Sep 2005	A1
20050216026	Culbert	Sep 2005	A1
20050222681	Richley et al.	Oct 2005	A1
20050251142	Hoffmann et al.	Nov 2005	A1
20050256525	Culbert et al.	Nov 2005	A1
20050256576	Moskowitz et al.	Nov 2005	A1
20050261769	Moskowitz et al.	Nov 2005	A1
20050278026	Gordon et al.	Dec 2005	A1
20050283238	Reiley	Dec 2005	A1
20060004326	Collins et al.	Jan 2006	A1
20060004457	Collins et al.	Jan 2006	A1
20060004458	Collins et al.	Jan 2006	A1
20060009778	Collins et al.	Jan 2006	A1
20060009779	Collins et al.	Jan 2006	A1
20060009851	Collins et al.	Jan 2006	A1
20060015105	Warren et al.	Jan 2006	A1
20060020284	Foley et al.	Jan 2006	A1
20060022180	Selness	Feb 2006	A1
20060030872	Culbert et al.	Feb 2006	A1
20060036246	Carl et al.	Feb 2006	A1
20060036256	Carl et al.	Feb 2006	A1
20060036259	Carl et al.	Feb 2006	A1
20060036323	Carl et al.	Feb 2006	A1
20060036324	Sachs et al.	Feb 2006	A1
20060041314	Millard	Feb 2006	A1
20060058790	Carl et al.	Mar 2006	A1
20060058807	Landry et al.	Mar 2006	A1
20060058876	McKinley	Mar 2006	A1
20060058880	Wysocki et al.	Mar 2006	A1
20060079908	Lieberman	Apr 2006	A1
20060084977	Lieberman	Apr 2006	A1
20060084988	Kim	Apr 2006	A1
20060085010	Lieberman	Apr 2006	A1
20060100706	Shadduck et al.	May 2006	A1
20060100707	Stinson et al.	May 2006	A1
20060106381	Ferree et al.	May 2006	A1
20060119629	An et al.	Jun 2006	A1
20060122609	Mirkovic et al.	Jun 2006	A1
20060122610	Culbert et al.	Jun 2006	A1
20060122701	Kiester	Jun 2006	A1
20060122703	Aebi et al.	Jun 2006	A1
20060129244	Ensign	Jun 2006	A1
20060136062	Dinello et al.	Jun 2006	A1
20060142759	Arnin et al.	Jun 2006	A1
20060142765	Dixon et al.	Jun 2006	A9
20060142776	Iwanari	Jun 2006	A1
20060142858	Colleran et al.	Jun 2006	A1
20060161166	Johnson et al.	Jul 2006	A1
20060178743	Carter	Aug 2006	A1
20060195103	Padget et al.	Aug 2006	A1
20060206207	Dryer et al.	Sep 2006	A1
20060217711	Stevens et al.	Sep 2006	A1
20060229629	Manzi et al.	Oct 2006	A1
20060235403	Blain	Oct 2006	A1
20060235412	Blain	Oct 2006	A1
20060235531	Buettner-Janz	Oct 2006	A1
20060247634	Warner et al.	Nov 2006	A1
20060253201	McLuen	Nov 2006	A1
20060265075	Baumgartner et al.	Nov 2006	A1
20060265077	Zwirkoski	Nov 2006	A1
20060276899	Zipnick et al.	Dec 2006	A1
20060276901	Zipnick et al.	Dec 2006	A1
20060276902	Zipnick et al.	Dec 2006	A1
20060293662	Boyer et al.	Dec 2006	A1
20060293663	Walkenhorst et al.	Dec 2006	A1
20070010826	Rhoda et al.	Jan 2007	A1
20070010886	Banick et al.	Jan 2007	A1
20070016191	Culbert et al.	Jan 2007	A1
20070032790	Aschmann et al.	Feb 2007	A1
20070055236	Hudgins et al.	Mar 2007	A1
20070055377	Hanson et al.	Mar 2007	A1
20070067035	Falahee	Mar 2007	A1
20070073399	Zipnick et al.	Mar 2007	A1
20070118132	Culbert et al.	May 2007	A1
20070118222	Lang	May 2007	A1
20070118223	Allard et al.	May 2007	A1
20070123868	Culbert et al.	May 2007	A1
20070123891	Ries et al.	May 2007	A1
20070123892	Ries et al.	May 2007	A1
20070129730	Woods et al.	Jun 2007	A1
20070149978	Shezifi et al.	Jun 2007	A1
20070162005	Peterson et al.	Jul 2007	A1
20070162138	Heinz	Jul 2007	A1
20070168036	Ainsworth et al.	Jul 2007	A1
20070173939	Kim et al.	Jul 2007	A1
20070173940	Hestad et al.	Jul 2007	A1
20070191954	Hansell et al.	Aug 2007	A1
20070191959	Hartmann et al.	Aug 2007	A1
20070198089	Moskowitz et al.	Aug 2007	A1
20070203491	Pasquet et al.	Aug 2007	A1
20070208423	Messerli et al.	Sep 2007	A1
20070219634	Greenhalgh et al.	Sep 2007	A1
20070233083	Abdou	Oct 2007	A1
20070233089	DiPoto et al.	Oct 2007	A1
20070233244	Lopez et al.	Oct 2007	A1
20070270954	Wu	Nov 2007	A1
20070270968	Baynham et al.	Nov 2007	A1
20070276375	Rapp	Nov 2007	A1
20070282449	De et al.	Dec 2007	A1
20070299521	Glenn et al.	Dec 2007	A1
20080009877	Sankaran et al.	Jan 2008	A1
20080015701	Garcia et al.	Jan 2008	A1
20080021556	Edie	Jan 2008	A1
20080021558	Thramann	Jan 2008	A1
20080027550	Link et al.	Jan 2008	A1
20080033440	Moskowitz et al.	Feb 2008	A1
20080058598	Ries et al.	Mar 2008	A1
20080058944	Duplessis et al.	Mar 2008	A1
20080065219	Dye	Mar 2008	A1
20080077148	Ries et al.	Mar 2008	A1
20080082172	Jackson	Apr 2008	A1
20080082173	Delurio et al.	Apr 2008	A1
20080097436	Culbert et al.	Apr 2008	A1
20080103601	Biro et al.	May 2008	A1
20080108996	Padget et al.	May 2008	A1
20080132934	Reiley et al.	Jun 2008	A1
20080140207	Olmos et al.	Jun 2008	A1
20080147193	Matthis et al.	Jun 2008	A1
20080161927	Savage et al.	Jul 2008	A1
20080167657	Greenhalgh	Jul 2008	A1
20080177388	Patterson et al.	Jul 2008	A1
20080183204	Greenhalgh et al.	Jul 2008	A1
20080195209	Garcia et al.	Aug 2008	A1
20080243251	Stad et al.	Oct 2008	A1
20080243254	Butler	Oct 2008	A1
20080249622	Gray	Oct 2008	A1
20080255618	Fisher et al.	Oct 2008	A1
20080262619	Ray	Oct 2008	A1
20080269904	Voorhies	Oct 2008	A1
20080281425	Thalgott et al.	Nov 2008	A1
20080287981	Culbert et al.	Nov 2008	A1
20080287997	Altarac et al.	Nov 2008	A1
20080300685	Carls et al.	Dec 2008	A1
20080306537	Culbert	Dec 2008	A1
20090005870	Hawkins et al.	Jan 2009	A1
20090005873	Slivka et al.	Jan 2009	A1
20090030423	Puno	Jan 2009	A1
20090048631	Bhatnagar et al.	Feb 2009	A1
20090054991	Biyani et al.	Feb 2009	A1
20090069813	Von et al.	Mar 2009	A1
20090076610	Afzal	Mar 2009	A1
20090099568	Lowry et al.	Apr 2009	A1
20090105745	Culbert	Apr 2009	A1
20090112320	Kraus	Apr 2009	A1
20090112324	Refai et al.	Apr 2009	A1
20090131986	Lee et al.	May 2009	A1
20090149857	Culbert et al.	Jun 2009	A1
20090164020	Janowski et al.	Jun 2009	A1
20090177284	Rogers et al.	Jul 2009	A1
20090182429	Humphreys et al.	Jul 2009	A1
20090222096	Trieu	Sep 2009	A1
20090222099	Liu et al.	Sep 2009	A1
20090222100	Cipoletti et al.	Sep 2009	A1
20090234398	Chirico et al.	Sep 2009	A1
20090240335	Arcenio et al.	Sep 2009	A1
20090248159	Aflatoon	Oct 2009	A1
20090275890	Leibowitz et al.	Nov 2009	A1
20090292361	Lopez	Nov 2009	A1
20100016905	Greenhalgh et al.	Jan 2010	A1
20100040332	Van et al.	Feb 2010	A1
20100076492	Warner et al.	Mar 2010	A1
20100076559	Bagga et al.	Mar 2010	A1
20100082109	Greenhalgh et al.	Apr 2010	A1
20100094424	Woodburn et al.	Apr 2010	A1
20100114147	Biyani	May 2010	A1
20100174314	Mirkovic et al.	Jul 2010	A1
20100179594	Theofilos et al.	Jul 2010	A1
20100191336	Greenhalgh	Jul 2010	A1
20100211176	Greenhalgh	Aug 2010	A1
20100234956	Attia et al.	Sep 2010	A1
20100262240	Chavatte et al.	Oct 2010	A1
20100268231	Kuslich et al.	Oct 2010	A1
20100286783	Lechmann et al.	Nov 2010	A1
20100292700	Ries	Nov 2010	A1
20100298938	Humphreys et al.	Nov 2010	A1
20100324607	Davis	Dec 2010	A1
20100331891	Culbert et al.	Dec 2010	A1
20110004308	Marino et al.	Jan 2011	A1
20110004310	Michelson	Jan 2011	A1
20110015747	McManus et al.	Jan 2011	A1
20110029082	Hall	Feb 2011	A1
20110035011	Cain	Feb 2011	A1
20110054538	Zehavi et al.	Mar 2011	A1
20110071527	Nelson et al.	Mar 2011	A1
20110093074	Glerum et al.	Apr 2011	A1
20110098531	To	Apr 2011	A1
20110098628	Yeung et al.	Apr 2011	A1
20110130835	Ashley et al.	Jun 2011	A1
20110130838	Morgenstern Lopez	Jun 2011	A1
20110144753	Marchek et al.	Jun 2011	A1
20110153020	Abdelgany et al.	Jun 2011	A1
20110172716	Glerum	Jul 2011	A1
20110172774	Varela	Jul 2011	A1
20110238072	Tyndall	Sep 2011	A1
20110270261	Mast et al.	Nov 2011	A1
20110270401	McKay	Nov 2011	A1
20110282453	Greenhalgh et al.	Nov 2011	A1
20110301711	Palmatier et al.	Dec 2011	A1
20110301712	Palmatier et al.	Dec 2011	A1
20110307010	Pradhan	Dec 2011	A1
20110313465	Warren et al.	Dec 2011	A1
20120004726	Greenhalgh et al.	Jan 2012	A1
20120004732	Goel et al.	Jan 2012	A1
20120022654	Farris et al.	Jan 2012	A1
20120029636	Ragab et al.	Feb 2012	A1
20120059474	Weiman	Mar 2012	A1
20120059475	Weiman	Mar 2012	A1
20120071977	Oglaza et al.	Mar 2012	A1
20120071980	Purcell et al.	Mar 2012	A1
20120083889	Purcell et al.	Apr 2012	A1
20120123546	Medina	May 2012	A1
20120150304	Glerum et al.	Jun 2012	A1
20120150305	Glerum et al.	Jun 2012	A1
20120158146	Glerum et al.	Jun 2012	A1
20120158147	Glerum et al.	Jun 2012	A1
20120158148	Glerum et al.	Jun 2012	A1
20120185049	Varela	Jul 2012	A1
20120197403	Merves	Aug 2012	A1
20120197405	Cuevas et al.	Aug 2012	A1
20120203290	Warren et al.	Aug 2012	A1
20120203347	Glerum et al.	Aug 2012	A1
20120215262	Culbert et al.	Aug 2012	A1
20120226357	Varela	Sep 2012	A1
20120232552	Morgenstern et al.	Sep 2012	A1
20120232658	Morgenstern et al.	Sep 2012	A1
20120265309	Glerum et al.	Oct 2012	A1
20120277795	Von et al.	Nov 2012	A1
20120290090	Glerum et al.	Nov 2012	A1
20120290097	Cipoletti et al.	Nov 2012	A1
20120310350	Farris et al.	Dec 2012	A1
20120310352	Dimauro et al.	Dec 2012	A1
20120323328	Weiman	Dec 2012	A1
20120330421	Weiman	Dec 2012	A1
20120330422	Weiman	Dec 2012	A1
20130006361	Glerum et al.	Jan 2013	A1
20130023993	Weiman	Jan 2013	A1
20130023994	Glerum	Jan 2013	A1
20130030536	Rhoda	Jan 2013	A1
20130085572	Glerum et al.	Apr 2013	A1
20130085574	Sledge	Apr 2013	A1
20130116791	Theofilos	May 2013	A1
20130123924	Butler et al.	May 2013	A1
20130123927	Malandain	May 2013	A1
20130138214	Greenhalgh et al.	May 2013	A1
20130144387	Walker et al.	Jun 2013	A1
20130144388	Emery et al.	Jun 2013	A1
20130158663	Miller et al.	Jun 2013	A1
20130158664	Palmatier et al.	Jun 2013	A1
20130158667	Tabor et al.	Jun 2013	A1
20130158668	Nichols et al.	Jun 2013	A1
20130158669	Sungarian et al.	Jun 2013	A1
20130173004	Greenhalgh et al.	Jul 2013	A1
20130190876	Drochner et al.	Jul 2013	A1
20130190877	Medina	Jul 2013	A1
20130204371	McLuen et al.	Aug 2013	A1
20130211525	McLuen et al.	Aug 2013	A1
20130211526	Alheidt et al.	Aug 2013	A1
20130310939	Fabian et al.	Nov 2013	A1
20140039622	Glerum et al.	Feb 2014	A1
20140046333	Johnson et al.	Feb 2014	A1
20140058513	Gahman et al.	Feb 2014	A1
20140067073	Hauck	Mar 2014	A1
20140094916	Glerum et al.	Apr 2014	A1
20140114423	Suedkamp et al.	Apr 2014	A1
20140128977	Glerum et al.	May 2014	A1
20140135934	Hansell et al.	May 2014	A1
20140142706	Hansell et al.	May 2014	A1
20140163683	Seifert et al.	Jun 2014	A1
20140172106	To et al.	Jun 2014	A1
20140180421	Glerum et al.	Jun 2014	A1
20140249629	Moskowitz et al.	Sep 2014	A1
20140249630	Weiman	Sep 2014	A1
20140257484	Flower et al.	Sep 2014	A1
20140257486	Alheidt	Sep 2014	A1
20140277139	Vrionis et al.	Sep 2014	A1
20140277204	Sandhu	Sep 2014	A1
20140303731	Glerum	Oct 2014	A1
20140303732	Rhoda et al.	Oct 2014	A1
20140324171	Glerum et al.	Oct 2014	A1
20150045894	Hawkins et al.	Feb 2015	A1
20150094610	Morgenstern et al.	Apr 2015	A1
20150094812	Cain	Apr 2015	A1
20150094813	Lechmann et al.	Apr 2015	A1
20150112398	Morgenstern et al.	Apr 2015	A1
20150320571	Lechmann et al.	Nov 2015	A1
20160331546	Lechmann et al.	Nov 2016	A1
20160367265	Morgenstern Lopez	Dec 2016	A1
20170290674	Olmos et al.	Oct 2017	A1

Foreign Referenced Citations (145)

Number	Date	Country
2005314079	Jun 2006	AU
1177918	Apr 1998	CN
101087566	Dec 2007	CN
101631516	Jan 2010	CN
101909548	Dec 2010	CN
2804936	Aug 1979	DE
3023353	Apr 1981	DE
3911610	Oct 1990	DE
4012622	Jul 1991	DE
19832798	Nov 1999	DE
20101793	May 2001	DE
202008001079	Mar 2008	DE
0077159	Apr 1983	EP
0260044	Mar 1988	EP
0270704	Jun 1988	EP
0282161	Sep 1988	EP
0433717	Jun 1991	EP
0525352	Feb 1993	EP
0611557	Aug 1994	EP
0625336	Nov 1994	EP
0678489	Oct 1995	EP
0853929	Jul 1998	EP
1046376	Oct 2000	EP
1290985	Mar 2003	EP
1374784	Jan 2004	EP
1378205	Jan 2004	EP
1532949	May 2005	EP
1541096	Jun 2005	EP
1683593	Jul 2006	EP
1698305	Sep 2006	EP
1843723	Oct 2007	EP
1845874	Oct 2007	EP
2331023	Jun 2011	EP
2368529	Sep 2011	EP
2237748	Sep 2012	EP
2764851	Aug 2014	EP
2649311	Jan 1991	FR
2699065	Jun 1994	FR
2718635	Oct 1995	FR
2728778	Jul 1996	FR
2730159	Aug 1996	FR
2745709	Sep 1997	FR
2800601	May 2001	FR
2801189	May 2001	FR
2808182	Nov 2001	FR
2874814	Mar 2006	FR
2157788	Oct 1985	GB
2173565	Oct 1986	GB
64-052439	Feb 1989	JP
6452439	Feb 1989	JP
06-500039	Jan 1994	JP
06-319742	Nov 1994	JP
07-502419	Mar 1995	JP
07-184922	Jul 1995	JP
10-085232	Apr 1998	JP
11-089854	Apr 1999	JP
2003-010197	Jan 2003	JP
2003-126266	May 2003	JP
2003-526457	Sep 2003	JP
2006-516456	Jul 2006	JP
2007-054666	Mar 2007	JP
2008-126085	Jun 2008	JP
2011-509766	Mar 2011	JP
2011-520580	Jul 2011	JP
4988203	Aug 2012	JP
5164571	Mar 2013	JP
9109572	Jul 1991	WO
9304652	Mar 1993	WO
9404100	Mar 1994	WO
9531158	Nov 1995	WO
9628100	Sep 1996	WO
9700054	Jan 1997	WO
9942062	Aug 1999	WO
9952478	Oct 1999	WO
9953871	Oct 1999	WO
9962417	Dec 1999	WO
0012033	Mar 2000	WO
0067652	May 2000	WO
0053127	Sep 2000	WO
0076409	Dec 2000	WO
2000074605	Dec 2000	WO
0101893	Jan 2001	WO
0101895	Jan 2001	WO
0112054	Feb 2001	WO
0117464	Mar 2001	WO
0168004	Sep 2001	WO
0180751	Nov 2001	WO
0243601	Jun 2002	WO
0321308	Mar 2003	WO
0343488	May 2003	WO
2004008949	Jan 2004	WO
2004064603	Aug 2004	WO
2004078220	Sep 2004	WO
2004078221	Sep 2004	WO
2004098453	Nov 2004	WO
2005112834	Dec 2005	WO
2005112835	Dec 2005	WO
2006017507	Feb 2006	WO
2006047587	May 2006	WO
2006058281	Jun 2006	WO
2006063083	Jun 2006	WO
2006065419	Jun 2006	WO
2006081843	Aug 2006	WO
2006108067	Oct 2006	WO
2007009107	Jan 2007	WO
2007028098	Mar 2007	WO
2007048012	Apr 2007	WO
2007119212	Oct 2007	WO
2007124130	Nov 2007	WO
2008044057	Apr 2008	WO
2008064842	Jun 2008	WO
2008070863	Jun 2008	WO
2009064787	May 2009	WO
2009092102	Jul 2009	WO
2009124269	Oct 2009	WO
2009143496	Nov 2009	WO
2009147527	Dec 2009	WO
2009152919	Dec 2009	WO
2010068725	Jun 2010	WO
2010136170	Dec 2010	WO
2010148112	Dec 2010	WO
2011079910	Jul 2011	WO
2011142761	Nov 2011	WO
2011150350	Dec 2011	WO
2012009152	Jan 2012	WO
2012089317	Jul 2012	WO
2012122294	Sep 2012	WO
2012135764	Oct 2012	WO
2013006669	Jan 2013	WO
2013023096	Feb 2013	WO
2013025876	Feb 2013	WO
2013043850	Mar 2013	WO
2013062903	May 2013	WO
2013082184	Jun 2013	WO
2013158294	Oct 2013	WO
2013173767	Nov 2013	WO
2013184946	Dec 2013	WO
2014018098	Jan 2014	WO
2014026007	Feb 2014	WO
2014035962	Mar 2014	WO
2014088521	Jun 2014	WO
2014116891	Jul 2014	WO
2014144696	Sep 2014	WO
2016069796	May 2016	WO
2016127139	Aug 2016	WO

Non-Patent Literature Citations (80)

Entry
Zucherman, “A Multicenter, Prospective, Randomized Trial Evaluating the X STOP Interspinous Process Decompression System for the Treatment of Neurogenic Intermittent Claudication”, Spine, vol. 30, No. 12, pp. 1351-1358, 2005.
Talwar “Insertion loads of the X STOP interspinous process distraction system designed to treat neurogenic intermittent claudication”, Eur Spine J. (2006) 15: pp. 908-912.
Spine Solutions Brochure—Prodisc 2001, 16 pages.
Slivka et al., In vitro compression testing of fiber-reinforced, bioabsorbable, porous implants. Synthetic Bioabsorbable Polymers for Implants. STP1396, pp. 124-135, ATSM International, Jul. 2000.
Shin, “Posterior Lumbar Interbody Fusion via a Unilateral Approach”, Yonsei Medical Journal, 2006, pp. 319-325, vol. 47(3).
Sep. 7, 2009 Office Action for European Application No. 05 853 282.1 filed Dec. 8, 2005.
Sep. 19, 2005 Office Action received in Australian Application No. 2002250488 filed Mar. 29, 2002.
Sep. 10, 2010 Supplementary European Search Report of European Application No. EP 0 674 0 578 filed on Apr. 4, 2006.
ProMap TM EMG Navigation Probe. Technical Brochure Spineology Inc, Dated May 2009.
Polikeit, “The Importance of the Endplate for Interbody Cages in the Lumbar Spine”, Eur. Spine J., 2003, pp. 556-561, vol. 12.
Paul D. Fuchs, “The use of an interspinous implant in conjunction with a graded facetectomy procedure”, Spine vol. 30, No. 11, pp. 1266-1272, 2005.
Niosi, Christina A., “Biomechanical Characterization of the three-dimentinoal kinematic behavior of the Dynesys dynamic stabilization system: an in vitro study”, Eur Spine J. (2006) 15: pp. 913-922.
Morgenstern R; “Transforaminal Endoscopic Stenosis Surgery—A Comparative Study of Laser and Reamed Foraminoplasty”, in European Musculoskeletal Review, Issue 1, 2009.
Method and Apparatus for Spinal Stabilization, U.S. Appl. No. 60/942,998.
Method and apparatus for spinal fixation, U.S. Appl. No. 60/424,055.
Method and apparatus for spinal fixation, U.S. Appl. No. 60/397,588.
Medco Forum, “Percutaneous Lumbar Fixation via PERPOS System From Interventional Spine”, Oct. 2007, vol. 14, No. 49.
Medco Forum, “Percutaneous Lumbar Fixation via PERPOS PLS System Interventional Spine”, Sep. 2008, vol. 15, No. 37.
May 27, 2009 Office Action for Japanese Patent Application No. 2005-50552 filed on Jul. 18, 2003.
May 25, 2012 Office Action for EP Application No. 04716128.6.
May 25, 2009 Notice of Allowance received in Canadian Application No. 2,442,334 filed Mar. 29, 2002.
Mar. 31, 2010 Office Action for Japanese Patent Application No. 2005-505552 filed Jul. 18, 2003.
Mar. 23, 2011 Office Action for Japanese Application No. 2005-505552 filed Jul. 18, 2003.
Mar. 14, 2012 Supplemental European Search Report for Application No. EP 05 77 7628.
Mar. 12, 2009 International Preliminary Report on Patentability, received in corresponding PCT Application No. PCT/US2007/009794 filed Apr. 20, 2007 in 5 pages.
Manal Siddiqui, “The Positional Magnetic Resonance Imaging Changes in the Lumbar Spine Following Insertion of a Novel Interspinous Process Distraction Device”, Spine vol. 30, No. 23, pp. 2677-2682.
Mahar et al., “Biomechanical Comparison of Novel Percutaneous Transfacet Device and a Traditional Posterior System for Single Level Fusion”, Journal of Spinal Disorders & Techniques, Dec. 2006, vol. 19, No. 8, pp. 591-594.
Link SB Charite Brochure—Intervertebral Prosthesis 1988, 29 pages.
Krbec, “Replacement of the Vertebral Body with an Expansion Implant (Synex)”, Acta Chir Orthop Traumatol Cech, 2002, pp. 158-162, vol. 69(3).
King, M.D., Don, “Internal Fixation for Lumbosacral Fusion”, The Journal of Bone and Joint Surgery, J. Bone Joint Surg Am., 1948; 30: 560-578.
Kambin et al., “Percutaneous Lateral Discectomy of the Lumbar Spine: A Preliminary Report”, Clin. Orthop,: 1983, 174: 127-132.
Jun. 25, 2012 International Search Report and Written Opinion for PCT Application No. PCT/US2012/028110, the PCT counterpart of the present application.
Jun. 22, 2006 European Search Report for Application No. 02719402.6 filed Mar. 29, 2002.
Jun. 18, 2007 Notice of Acceptance received in Australian Application No. 2002250488 filed Mar. 29, 2002.
Jul. 7, 2008 International Search Report and Written Opinion received in co-pending PCT Application No. PCT/US2005/027431 filed Aug. 2, 2005.
Jul. 3, 2008 Office Action received for Canadian Application No. 2,442,334 filed Mar. 29, 2002.
Jul. 2, 2009 Office Action for U.S. Appl. No. 11/308,767, filed May 1, 2006.
Jul. 7 5, 2011 Office Action (Rejection Notice dated Jul. 13, 2011) for Japanese Application No. 2007-545602.
Jan. 9, 2008 Supplemental Partial European Search Report received in corresponding European Application No. 0471618.
Jan. 27, 2011 Office Action for Australian Application No. 2005314079 filed Dec. 8, 2005.
Jan. 26, 2005 International Search Report and Written Opinion received in corresponding PCT App. No. PCT/US04/06129, 13 pages.
Iprenburg et al., “Transforaminal Endoscopic Surgery in Lumbar Disc Herniation in an Economic Crisis—The TESSYS Method”, US Musculoskeletal, 2008, p. 47-49.
International Search Report and Written Opinion received in co-pending PCT application No. PCT/US2007/086866 dated Jul. 7, 2008, 11 pages.
International Search Report & Written Opinion received in corresponding PCT Application No. PCT/US2006/012728 dated May 30, 2008, 9 pages.
Hunt, “Expandable Cage Placement via a Posterolateral Approach in Lumbar Spine Reconstructions”, Journal of Neurosurgery: Spine, Sep. 2006, pp. 271-274, vol. 5.
Hoogland et al., “Total Lumar Intervertebral Disc Replacement: Testing a New Articulating Space in Human Cadaver Spines—24 1”, Annual ORS, Dallas, TX, Feb. 21-23, 1978, 8 pages.
Gray's Anatomy, Crown Publishers, Inc., 1977, pp. 33-54.
Gore, “Technique of Cervical Interbody Fusion”, Clinical Orthopaedics and Related Research, Sep. 1984, pp. 191-195, No. 188.
Folman, Posterior Lumbar Interbody Fusion for Degenerative Disc Disease Using a Minimally Invasive B-Twin Expandable Spinal Spacer, Journal of Spinal Disorders & Techniques, 2003, pp. 455-460, vol. 16(5).
Feb. 7, 2011 Office Action for Japanese Application No. 2007-524917 filed Aug. 2, 2005.
Feb. 24, 2012 Office Action for Japanese Application No. 2007-524917 filed Aug. 2, 2005.
Expandable Intervertebral Implant, U.S. Appl. No. 14/685,402.
Expandable Intervertebral Implant, U.S. Appl. No. 14/685,358.
Expandable Intervertebral Implant, U.S. Appl. No. 14/640,220.
Expandable Implant, U.S. Appl. No. 61/675,975.
Expandable Implant, U.S. Appl. No. 14/790,866.
Chin, Kingsley R., M.D. “Early Results of the Triage Medical Percutaneous Transfacet Pedicular BONE-LOK Compression Device for Lumbar Fusion”, accessed online Jul. 10, 2017, 10 pages.
Chiang, “Biomechanical Comparison of Instrumented Posterior Lumbar Interbody Fusion with One or Two Cages by Finite Element Analysis”, Spine, Sep. 2006, pp. E682- E689, vol. 31(19), Lippincott Williams & Wilkins, Inc.
Brooks et al., “Efficacy of Supplemental Posterior Transfacet Pedicle Device Fixation in the Setting of One- or Two-Level Anterior Lumbar Interbody Fusion”, Retrieved Jun. 19, 2017, 6 pages.
Brochure for PERPOS PLS System Surgical Technique by Interventional Spine, 2008, 8 pages.
Aug. 4, 2009 Extended European Search Report received in European Application No. 09164698.4, 5 pages.
Aug. 4, 2005 EPO Examination Report for App. No. 01 932 643.8.
Apr. 6, 2007 Office Action received in Chinese Application No. 0281039.7 filed Mar. 29, 2002.
Apr. 3, 2009 Extended European Search Report received in European Application No. 09152476.9 in 5 pages.
Apr. 29, 2008 Notice of Preliminary Rejection in Korean Application No. 2003-7012847 filed Mar. 29, 2002.
Apr. 28, 2011 Supplementary European Search Report for Application No. EP 07 75 5880 filed Apr. 20, 2007.
Apr. 22, 2008 Supplemental ISR received in corresponding EP Application No. 04716129.4.
Apr. 22, 2004 International Search Repon for App. No. PCT/US03/23645 filed Jul. 18, 2003.
Apr. 20, 2010 International Search Report and Written Opinion in co-pending PCT Application No. PCT/IB2009/005972 in 19 pages.
Apr. 2, 2012 Office Action (to proceed and to respond to Search Report) for Application No. 0577628.8.
Apr. 19, 2007 Office Action for European Application No. 02 719 402.6 filed Mar. 29, 2002.
Apr. 18, 2007 EPO Examination Report for App. No. 01 932 643.8.
Apr. 17, 2008 International Search Report and Written Opinion from corresponding PCT Application No. PCT/US07/09794 filed Apr. 20, 2007 in 8 pages.
Apr. 13, 2006 International Search Report for App. No. PCT/US2005/044321.
Alfen et al., “Developments in the area of Endoscopic Spine Surgery”, European Musculoskeletal Review 2006, pp. 23-24, ThessysTM, Transforaminal Endoscopic Spine Systems, joi max Medical Solutions.
U.S. Appl. No. 60/942,998, Method and Apparatus for Spinal Stabilization, filed Jun. 8, 2007.
U.S. Appl. No. 61/675,975, Expandable Implant, filed Jul. 26, 2012.
U.S. Appl. No. 60/397,588, Method and apparatus for spinal fixation, filed Jul. 19, 2002.
U.S. Appl. No. 60/794,171, Method and apparatus for spinal fixation, filed Apr. 21, 2006.
U.S. Appl. No. 60/424,055, filed Nov. 5, 2002, entitled Method and apparatus for spinal fixation.

Related Publications (1)

	Number	Date	Country
	20170290678 A1	Oct 2017	US

Provisional Applications (1)

	Number	Date	Country
	60869088	Dec 2006	US

Divisions (1)

	Number	Date	Country
Parent	13845644	Mar 2013	US
Child	15629071		US

Continuations (1)

	Number	Date	Country
Parent	13334526	Dec 2011	US
Child	13845644		US

Intervertebral implant

Information

Patent Number

Date Filed

Date Issued

Inventors

Original Assignees

Examiners

Agents

CPC

Field of Search

CPC

International Classifications

Disclaimer

Term Extension

Abstract