US20090198338A1 - Medical implants and methods - Google Patents

Abstract

An apparatus includes a spacer and an actuator. The spacer has a first spacer member configured to engage an endplate of a first vertebra and a second spacer member configured to engage an endplate of a second vertebra. The actuator has a first actuator member and a second actuator member coupled to the first actuator member. Each of the first actuator member and the second actuator member is matingly and movably coupled to the first spacer member and the second spacer member. The actuator is configured to move the spacer between a first configuration and a second configuration. The first spacer member is in contact with the second spacer member when the spacer is in the first configuration. The first spacer member is spaced apart from the second spacer member by a non-zero distance when the spacer is in the second configuration.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims priority to U.S. Provisional Application Ser. No. 61/025,991, entitled “Medical Implants and Methods,” filed Feb. 4, 2008, which is incorporated herein by reference in its entirety.
• This application is related to U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2271, entitled “Tools and Methods for Insertion and Removal of Medical Implants,” KYPH-040/03US 305363-2270, entitled “Medical Implants and Methods,” and KYPH-040/04US 305363-2272, entitled “Spine Distraction Tools and Methods of Use,” each of which is filed herewith, and each of which is incorporated herein by reference in its entirety.
BACKGROUND
• The invention relates generally to the treatment of spinal conditions, and more particularly, to the treatment of spinal compression using percutaneous spinal implants for implantation between adjacent spinous processes and/or percutaneous spinal implants for implantation in a space associated with an intervertebral disc.
• Minimally-invasive procedures have been developed to provide access to the space between adjacent spinous processes such that major surgery is not required. Such known procedures, however, may not be suitable in conditions where the spinous processes are severely compressed. Moreover, such procedures typically involve large or multiple incisions. Further, some of the known implants configured to be inserted into a space associated with an intervertebral disc are non-expandable and involve an invasive open procedure.
• Thus, a need exists for improvements in spinal implants for implantation between adjacent spinous processes. Additionally, a need exists for improvements in spinal implants for implantation in a space associated with an intervertebral disc. A further need exists for improvements in the tools used in placing spinal implants.
SUMMARY
• Spinal implants and methods are described herein. In some embodiments, an apparatus includes a spacer and an actuator. The spacer has a first spacer member configured to engage an endplate of a first vertebra and a second spacer member configured to engage an endplate of a second vertebra. The second vertebra can be adjacent the first vertebra. The actuator has a first actuator member and a second actuator member coupled to the first actuator member. The first actuator member is matingly and movably coupled to the first spacer member. Similarly, the first actuator is matingly and movably coupled to the second spacer member. The second actuator member is matingly and movably coupled to the first spacer member. Similarly, the second actuator member is matingly and movably coupled to the second spacer member. The actuator is configured to move the spacer between a first configuration and a second configuration. The first spacer member is in contact with the second spacer member when the spacer is in the first configuration. The first spacer member is spaced apart from the second spacer member by a non-zero distance when the spacer is in the second configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS. 1 and 2 are schematic illustrations of an implant, according to an embodiment in a first configuration and a second configuration, respectively.
• FIGS. 3 and 4 are schematic illustrations of an implant, according to an embodiment in a first configuration and a second configuration, respectively.
• FIGS. 5 and 6 are schematic illustrations of an implant, according to an embodiment in a first configuration and a second configuration, respectively.
• FIGS. 7 and 8 are perspective views of an implant, according to an embodiment in a first configuration and a second configuration, respectively.
• FIG. 9 is a side view of the implant shown inFIG. 8 in the second configuration.
• FIG. 10 is a top view of the implant shown inFIG. 7 in the first configuration.
• FIG. 11 is a bottom view of the implant shown inFIG. 7 in the first configuration.
• FIG. 12 is a cross-sectional view of the implant shown inFIGS. 7,10 and11 in the first configuration, taken along line X-X inFIG. 10.
• FIG. 13 is a cross-sectional view of the implant shown inFIG. 12 in the second configuration.
• FIG. 14 is a top perspective view of an implant according to an embodiment, in a first configuration.
• FIG. 15 is a side perspective view of the implant shown inFIG. 14 in the first configuration.
• FIG. 16 is a cross-sectional view of the implant shown inFIGS. 14 and 15, taken along line X-X inFIG. 14.
• FIG. 17 is a top perspective view of the implant shown inFIG. 14 in a second configuration.
• FIG. 18 is a side perspective view of the implant shown inFIG. 14 in the second configuration.
• FIG. 19 is a cross-sectional view of the implant shown inFIGS. 17 and 18 in the second configuration.
• FIGS. 20 and 21 are exploded views of the implant illustrated inFIGS. 14-19.
• FIG. 22 is a perspective view of an implant according to an embodiment, in a first configuration.
• FIG. 23 is a cross-sectional view of the implant shown inFIG. 22 coupled to an insertion tool.
• FIGS. 24 and 25 are perspective views of an implant, according to an embodiment in a first configuration and a second configuration, respectively.
• FIG. 26 is a side view of the implant shown inFIG. 25 in the second configuration.
• FIG. 27 is a top view of the implant shown inFIG. 24 in the first configuration.
• FIG. 28 is a cross-sectional view of the implant shown inFIG. 24, taken along line X-X inFIG. 24.
• FIG. 29 is a cross-sectional view of the implant shown inFIG. 27, taken along line X-X inFIG. 27.
• FIG. 30 is a cross-sectional view of the implant shown inFIG. 29 in the second configuration.
• FIGS. 31 and 32 are perspective views of an implant, according to an embodiment in a first configuration and a second configuration, respectively.
• FIG. 33 is a cross-sectional view of the implant shown inFIG. 32 in the second configuration, taken along line X-X inFIG. 32.
• FIG. 34 is a top view of the implant shown inFIG. 31 in the first configuration.
• FIG. 35 is a side view of the implant shown inFIG. 31 in the first configuration.
• FIG. 36 is a side view of the implant shown inFIG. 32 in the second configuration.
• FIG. 37 is a cross-sectional view of the implant shown inFIG. 35, taken along line Y-Y inFIG. 35.
• FIG. 38 is a cross-sectional view of the implant shown inFIG. 34 in the first configuration, taken along line X-X inFIG. 34.
• FIG. 39 is a cross-sectional view of the implant shown inFIG. 38 in the second configuration.
• FIG. 40 is a perspective view of an insertion member of the implant shown inFIG. 31.
• FIG. 41 is a perspective view of a support member of the implant shown inFIG. 31.
• FIG. 42 is a perspective view of a retention member of the implant shown inFIG. 31.
• FIG. 43 is a perspective view of a tool engagement member of the implant shown inFIG. 31.
• FIG. 44 is a perspective view of a cap of the implant shown inFIG. 31.
• FIGS. 45 and 46 are schematic illustrations of an implant, according to an embodiment in a first configuration and a second configuration, respectively.
• FIGS. 47 and 48 are perspective views of an implant, according to an embodiment in a first configuration and a second configuration, respectively.
• FIGS. 49 and 50 are perspective views of the implant shown inFIG. 47 in a first configuration and a second configuration, respectively.
• FIG. 51 is a side view of the implant shown inFIG. 47 in the first configuration.
• FIG. 52 is a side view of the implant shown inFIG. 48 in the second configuration.
• FIG. 53 is a top view of the implant shown inFIG. 47 in the first configuration.
• FIG. 54 is a cross-sectional view of the implant shown inFIG. 53 in the first configuration, taken along line X-X inFIG. 53.
• FIG. 55 is a cross-sectional view of the implant shown inFIG. 54 in the second configuration.
• FIG. 56 is a cross-sectional view of the implant shown inFIG. 51 in the first configuration, taken along line X-X inFIG. 51.
• FIG. 57 is a perspective view of an insertion member of the implant shown inFIG. 47.
• FIG. 58 is a perspective view of a tool engagement member of the implant shown inFIG. 47.
• FIG. 59 is a perspective view of an intermediate member of the implant shown inFIG. 47.
• FIG. 60 is a perspective view of a central support member of the implant shown inFIG. 47.
• FIGS. 61-63 show various views of an implant according to an embodiment.
• FIG. 64 shows a connection portion of an implant according to an embodiment.
• FIG. 65 shows a connection portion of an implant according to an embodiment.
• FIG. 66 shows a connection portion of an implant according to an embodiment.
DETAILED DESCRIPTION
• In some embodiments, an apparatus includes a spacer, a proximal retention member, a distal retention member, and an actuator. The spacer defines a longitudinal axis and includes a proximal surface and a distal surface opposite the proximal surface. The spacer is configured to engage a first spinous process and a second spinous process. The proximal retention member is coupled to the spacer such that a portion of the proximal retention member is in contact with the proximal surface of the spacer. The distal retention member includes a first surface and a second surface. The distal retention member is movably coupled to the spacer such that the second surface is in contact with the distal surface of the spacer. An axis within a plane defined by the first surface of the distal retention member is non-parallel to and non-normal to the longitudinal axis defined by the spacer. The actuator is movably coupled to the spacer and is configured to move relative to the spacer along the longitudinal axis defined by the spacer. The actuator includes an actuation surface that is slidably coupled to and substantially parallel to the first surface of the distal retention member.
• In some embodiments, an apparatus includes an interspinous process implant. The interspinous process implant includes a central body, a proximal retention member, and a distal retention member, and defines a longitudinal axis. The central body includes a proximal surface, a distal surface and an outer surface. The proximal retention member has an engagement surface and an outer surface. The proximal retention member is movably coupled to the central body such that the engagement surface of the proximal retention member is slidably coupled to the proximal surface of the central body. The distal retention member has an engagement surface and an outer surface. The distal retention member is movably coupled to the central body such that the engagement surface of the distal retention member is slidably coupled to the distal surface of the central body. The interspinous process implant can be moved between a first configuration and a second configuration. The outer surface of the central body, the outer surface of the proximal retention member and the outer surface of the distal retention member are substantially aligned when the interspinous process implant is in the first configuration. The outer surface of the central body, a portion of the engagement surface of the proximal retention member and a portion of the engagement surface of the distal retention member collectively form a saddle when the interspinous process implant is in the second configuration. The saddle is configured to receive a spinous process.
• In some embodiments, an apparatus includes a spacer, a proximal retention member, a distal retention member, and an actuator. The spacer has a proximal surface and a distal surface opposite the proximal surface, and defines a longitudinal axis. The spacer is configured to engage a spinous process. The proximal retention member is coupled to the spacer such that a portion of the proximal retention member is in contact with the proximal surface of the spacer. The distal retention member includes a surface that defines a dovetail groove. The distal retention member is movably coupled to the spacer such that a portion of the distal retention member is in contact with the distal surface of the spacer. The actuator is movably coupled to the spacer and has an actuation surface having a dovetail protrusion. The dovetail protrusion of the actuation surface of the actuator is configured to be matingly received within the dovetail groove defined by the surface of the distal retention member.
• In some embodiments, an apparatus includes a spacer, a first retention member, a second retention member and an actuator. The spacer includes a surface and defines a longitudinal axis. The spacer is configured to engage a spinous process. The first retention member has a first surface and a second surface. The first retention member is movably coupled to the spacer such that the second surface of the first retention member is slidably coupled to the surface of the spacer. An axis within a plane defined by the first surface of the first retention member is non-parallel to and non-normal to the longitudinal axis defined by the spacer. The second retention member includes a first surface and a second surface. The second retention member is movably coupled to the spacer such that the second surface of the second retention member is slidably coupled to the surface of the spacer. The actuator is movably coupled to the spacer and includes a tapered portion having a first actuation surface and a second actuation surface. The first actuation surface is slidably coupled to and substantially parallel to the first surface of the first retention member. The second actuation surface is slidably coupled to and substantially parallel to the first surface of the second retention member.
• In some embodiments, an apparatus includes a spacer, a retention assembly and an actuator. The spacer is configured to engage adjacent spinous processes. The spacer has a first size along an axis normal to a longitudinal axis of the spacer when in a first configuration and a second size along the axis normal to the longitudinal axis when in a second configuration. The second size of the spacer is greater than the first size of the spacer. The retention assembly includes a first surface and a second surface. The retention assembly has a first size along the axis normal to the longitudinal axis of the spacer when in a first configuration and a second size along the axis normal to the longitudinal axis when in a second configuration. The second size of the retention assembly is greater than the first size of the retention assembly. The retention assembly is movably coupled to the spacer such that the second surface of the retention assembly is in contact with a surface of the spacer. An axis within a plane defined by the first surface of the retention assembly is non-parallel to and non-normal to the longitudinal axis of the spacer. The actuator is movably coupled to the spacer and includes an actuation surface slidably coupled to and substantially parallel to the first surface of the retention assembly. The actuator is configured to move the retention assembly between its first configuration and its second configuration. Further, the actuator is configured to move the spacer between its first configuration and its second configuration.
• As used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a member” is intended to mean a single member or a combination of members, “a material” is intended to mean one or more materials, or a combination thereof. Furthermore, the words “proximal” and “distal” refer to direction closer to and away from, respectively, an operator (e.g., surgeon, physician, nurse, technician, etc.) who would insert the medical device into the patient, with the tip-end (i.e., distal end) of the device inserted inside a patient's body first. Thus, for example, the implant end first inserted inside the patient's body would be the distal end of the implant, while the implant end to last enter the patient's body would be the proximal end of the implant.
• The term “parallel” is used herein to describe a relationship between two geometric constructions (e.g., two lines, two planes, a line and a plane, two curved surfaces, a line and a curved surface or the like) in which the two geometric constructions are substantially non-intersecting as they extend substantially to infinity. For example, as used herein, a line is said to be parallel to a curved surface when the line and the curved surface do not intersect as they extend to infinity. Similarly, when a planar surface (i.e., a two-dimensional surface) is said to be parallel to a line, every point along the line is spaced apart from the nearest portion of the surface by a substantially equal distance. Two geometric constructions are described herein as being “parallel” or “substantially parallel” to each other when they are nominally parallel to each other, such as for example, when they are parallel to each other within a tolerance. Such tolerances can include, for example, manufacturing tolerances, measurement tolerances or the like.
• The term “normal” is used herein to describe a relationship between two geometric constructions (e.g., two lines, two planes, a line and a plane, two curved surfaces, a line and a curved surface or the like) in which the two geometric constructions intersect at an angle of approximately 90 degrees within at least one plane. For example, as used herein, a line is said to be normal to a curved surface when the line and an axis tangent to the curved surface intersect at an angle of approximately 90 degrees within a plane. Two geometric constructions are described herein as being “normal” or “substantially normal” to each other when they are nominally normal to each other, such as for example, when they are normal to each other within a tolerance. Such tolerances can include, for example, manufacturing tolerances, measurement tolerances or the like.
• It should be understood that the references to geometric constructions are for purposes of discussion and illustration. The actual structures may differ from geometric ideal due to tolerances and/or other minor deviations from the geometric ideal.
• FIGS. 1 and 2 are schematic illustrations of animplant100, according to an embodiment, in a first configuration and a second configuration, respectively.Implant100 includes aspacer140, aproximal retention member160, adistal retention member120, and anactuator111. Thespacer140 of theimplant100 includes aproximal surface142, adistal surface143, and anouter surface141, and defines a longitudinal axis A_L. At least a portion of theimplant100 is configured to be disposed in a space between a first spinous process SP1 and a second spinous process SP2 such that thespacer140 of theimplant100 engages the first spinous process SP1 and the second spinous process SP2 during spinal extension, either directly or through surrounding tissue. Said another way, at least during spinal extension, theouter surface141 of thespacer140 is configured to directly engage and/or contact the spinous processes SP1, SP2 and/or the bodily tissue surrounding the spinous processes SP1, SP2 without any intervening structure associated with theimplant100. In some embodiments, for example, a portion of thespacer140 is disposed within an opening defined in the interspinous ligament (not shown). In this manner, thespacer140 can contact the spinous processes SP1, SP2 through the interspinous ligament. For purposes of clarity, however, the tissue surrounding the spinous processes SP1, SP2 is not illustrated.
• Theproximal retention member160 of theimplant100 is coupled to thespacer140 such that at least a portion of theproximal retention member160 is adjacent theproximal surface142 of thespacer140. In some embodiments, a portion of theproximal retention member160 can be in contact with theproximal surface142 of thespacer140. In other embodiments, theproximal retention member160 can be spaced apart from theproximal surface142 of thespacer140. In some embodiments, theproximal retention member160 can be movably coupled to thespacer140. In other embodiments, theproximal retention member160 can be removably coupled to thespacer140.
• Thedistal retention member120 of theimplant100 is movably coupled to thespacer140, and includes afirst surface122, asecond surface123, and anouter surface121. An axis A_pwithin a plane defined by thefirst surface122 of thedistal retention member120 is non-parallel to and non-normal to the longitudinal axis A_L. Said another way, thefirst surface122 of thedistal retention member120 is angularly offset from the longitudinal axis A_Lby an angle θ₁. The angle θ₁, which is defined by thefirst surface122 of thedistal retention member120 and the longitudinal axis A_L, is supplementary to the angle θ₂, which is defined by theactuation surface116 of theactuator111 and the longitudinal axis A_L, as further described herein. Moreover, thefirst surface122 of thedistal retention member120 is substantially parallel to theactuation surface116 of theactuator111.
• Thedistal retention member120 is coupled to thespacer140 such that thesecond surface123 of thedistal retention member120 is in contact with thedistal surface143 of thespacer140. As shown inFIGS. 1 and 2, thesecond surface123 of thedistal retention member120 is substantially normal to the longitudinal axis A_L. Moreover, thesecond surface123 of thedistal retention member120 is substantially parallel to thedistal surface143 of thespacer140. Said another way, thesecond surface123 of thedistal retention member120 defines an angle with respect to the longitudinal axis A_Lthat is supplementary to an angle defined by thedistal surface143 of thespacer140 with respect to the longitudinal axis A_L.
• Theactuator111 of theimplant100 is movably coupled to thespacer140, and includes anactuation surface116. Theactuation surface116 is slidably coupled to and substantially parallel to thefirst surface122 of thedistal retention member120. Said another way, the axis A′_Pis within a plane defined by theactuation surface116 of theactuator111. As shown inFIG. 1, theactuation surface116 of theactuator111 is angularly offset from the longitudinal axis A_Lby an angle θ₂. The angle θ₂, which is defined by theactuation surface116 of theactuator111 and the longitudinal axis A_L, is supplementary to the angle θ₁, as described above.
• As shown inFIGS. 1 and 2, theimplant100 is movable between a first configuration (FIG. 1) and a second configuration (FIG. 2). When theimplant100 is in the first configuration, theactuator111 is spaced apart from thedistal surface143 of thespacer140 along the longitudinal axis A_Lby a non-zero distance D1. When theimplant100 is in the first configuration, theouter surface121 of thedistal retention member120 is substantially aligned with theouter surface141 of thespacer140. Said another way, theouter surface121 of thedistal retention member140 and theouter surface141 of thespacer140 form a substantially continuous surface. Said yet another way, theouter surface121 of thedistal retention member120 is substantially flush with theouter surface141 of thespacer140. Said still another way, thesecond surface123 of thedistal retention member120 and thedistal surface143 of thespacer140 are aligned.
• To move theimplant100 to the second configuration, theactuator111 is moved along the longitudinal axis A_Lin the direction shown by the arrow AAA inFIG. 2. Movement of theactuator111 causes theactuation surface116 of theactuator111 to exert an axial force on thefirst surface122 of thedistal retention member120. Because theactuation surface116 of theactuator111 is at an angle θ₂with respect to the longitudinal axis A_L, a component of the axial force transmitted via theactuation surface116 to thefirst surface122 of thedistal retention member120 has a direction as shown by the arrow BBB inFIG. 2. Said another way, a component of the force exerted by theactuator111 on thedistal retention member120 has a direction that is substantially normal to the longitudinal axis A_L. Accordingly, the force exerted by theactuator111 on thedistal retention member120 causes thefirst surface122 of thedistal retention member120 to slide on theactuation surface116 of theactuator111, and causes thedistal retention member120 to move in the direction shown by the arrow BBB inFIG. 2.
• As shown inFIG. 2, when theimplant100 is in the second configuration, theactuator111 is spaced apart from thedistal surface143 of thespacer140 along the longitudinal axis A_Lby a non-zero distance D2, which is less than the distance D1. Although shown inFIG. 2 as being spaced apart by the distance D2, in other embodiments, theactuator111 can be in contact with thedistal surface143 of thespacer140 when theimplant100 is in the second configuration. In such embodiments, after theactuator111 moves a predetermined distance along the longitudinal axis A_L, theactuator111 can contact thedistal surface143 of thespacer140, limiting the range of motion of theactuator111 relative to thespacer140.
• When theimplant100 is in the second configuration, thedistal retention member120 is offset from thespacer140 in a direction substantially normal to the longitudinal axis A_L, as shown by the arrow BBB inFIG. 2. Said another way, theouter surface121 of thedistal retention member120 is not aligned with theouter surface141 of thespacer140 and is discontinuous with theouter surface141 of thespacer140. Said yet another way, theouter surface121 of thedistal retention member120 is spaced apart from theouter surface141 of thespacer140 by a non-zero distance D3. In this manner, thedistal retention member120, theproximal retention member160 and thespacer140 form a saddle, as further described herein.
• The angle θ₁of thefirst surface122 of thedistal retention member120 and the angle θ₂of theactuation surface116 of theactuator120 can be any suitable angle. The value of the angles θ₁and θ₂can influence the force to move theimplant100 from the first configuration to the second configuration and/or the axial distance through which theactuator111 travels when theimplant100 is moved from the first configuration to the second configuration. More particularly, if the angle θ₁is close to 180 degrees (e.g., between 165 and 180 degrees) and the angle θ₂is close to 0 degrees (e.g., between 0 and 15 degrees), the force to move theimplant100 from the first configuration to the second configuration will be less than the force needed if the angle θ₁and the angle θ₂are both close to 90 degrees. Said another way, when thefirst surface122 of thedistal retention member120 and theactuation surface116 of theactuator111 are close to being parallel to the longitudinal axis A_L, less force is needed to move theimplant100 to the second configuration than when thefirst surface122 of thedistal retention member120 and theactuation surface116 of theactuator111 are close to being normal to the longitudinal axis. If the angle θ₁is close to 180 degrees and the angle θ₂is close to 0 degrees, however, the distance theactuator111 travels along the longitudinal axis A_Lto move theimplant100 from the first configuration to the second configuration to achieve the desired offset of the retention member120 (e.g., D3), will be greater than the distance theactuator111 travels if the angle θ₁and the angle θ₂are both close to 90 degrees.
• In use, theimplant100 can be inserted between a first spinous process SP1 and a second spinous process SP2 when theimplant100 is in the first configuration (see e.g.,FIG. 1). For example, a medical practitioner can insert theimplant100 percutaneously into a body of a patient. In some embodiments, theimplant100 can be inserted percutaneously via a cannula. In some embodiments, a tool, such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for Insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety, can be used to insert theimplant100 into a body of a patient.
• After theimplant100 is between the first spinous process SP1 and the second spinous process SP2, theimplant100 can be moved from the first configuration to the second configuration (see e.g.,FIG. 2). In some embodiments, theimplant100 can be actuated using a tool (not shown) configured to move theactuator111 relative to thespacer140 when the implant is within the body. Such tools can include, for example, those tools described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for Insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. As stated above, when theimplant100 is in the second configuration, thedistal retention member120, theproximal retention member160 and thespacer140 form a saddle, within which the first spinous process SP1 is disposed. In this manner, when theimplant100 is in the second configuration, thedistal retention member120 and theproximal retention member160 can collectively limit movement of thespacer140 with respect to the first spinous process SP1 along the longitudinal axis A_L.
• A medical practitioner can remove theimplant100 from and/or reposition theimplant100 within the body. To remove from and/or reposition theimplant100 within the body, theimplant100 can be moved from the second configuration to the first configuration. This can be done by moving theactuator111 in a direction opposite the direction shown by the arrow AAA inFIG. 2. This causes theimplant100 to return to the first configuration. After theimplant100 is in the first configuration, the medical practitioner can remove theimplant100 from and/or reposition theimplant100 within the body.
• Although thedistal surface143 of thespacer140 is shown and described as being substantially normal to the longitudinal axis A_L, in some embodiments, thedistal surface143 of thespacer140 can be angularly offset from the longitudinal axis A_L. Said another way, in some embodiments, theproximal surface142 of thespacer140 and/or thedistal surface143 of thespacer140 can define an angle with respect to the longitudinal axis A_Lthat is not ninety degrees. For example, in some embodiments, thedistal surface143 of thespacer140 can define an obtuse angle with respect to the longitudinal axis A_L, and thesecond surface123 of thedistal retention member120 can define a supplementary acute angle with respect to the longitudinal axis A_L. In other embodiments, thedistal surface143 of thespacer140 can define an acute angle with respect to the longitudinal axis A_L, and thesecond surface123 of thedistal retention member120 can define a supplementary obtuse angle with respect to the longitudinal axis A_L. Such a non-normal arrangement of angles causes thedistal retention member120 to move in a direction substantially parallel to thedistal surface143 of thespacer140 when theimplant100 is moved from the first configuration to the second configuration. Thus, the angle of thedistal surface143 of thespacer140 affects the direction of movement of thedistal retention member120 when theimplant100 moves from the first configuration to the second configuration. In this manner, thedistal retention member120 can be configured to move in a direction non-normal to the longitudinal axis A_L. For example, in some embodiments, thedistal retention member120 can move distally (i.e., away from the spinous process SP1) relative to thespacer111 when theimplant100 moves from the first configuration to the second configuration. In other embodiments, thedistal retention member120 can move proximally (i.e., towards the spinous process SP1) relative to thespacer111 when theimplant100 moves from the first configuration to the second configuration. The proximal movement of thedistal retention member120 can be used, for example, to cause thedistal retention member120 to contact the spinous process SP1 when in the second configuration.
• Although theouter surface121 of thedistal retention member120 is shown and described as being substantially aligned with theouter surface141 of thespacer140 when theimplant100 is in the first configuration, in some embodiments, theouter surface121 of thedistal retention member120 can be offset from theouter surface141 of the spacer when theimplant100 is in the first configuration. Said another way, in some embodiments, theouter surface121 of thedistal retention member120 can be discontinuous with theouter surface141 of thespacer140 when theimplant100 is in the first configuration. Said yet another way, in some embodiments, theouter surface121 of thedistal retention member120 can be spaced apart from theouter surface141 of thespacer140 by a distance different than distance D3 (the distance theouter surface121 of thedistal retention member120 is spaced apart from theouter surface141 of thespacer140 when theimplant100 is in the second configuration) when theimplant100 is in the first configuration.
• FIGS. 3 and 4 are schematic illustrations of animplant200, according to an embodiment. Theimplant200 includes acentral body240, aproximal retention member260, and adistal retention member220, and defines a longitudinal axis A_L. Thecentral body240 includes aproximal surface242, adistal surface243 and anouter surface241. At least a portion of thecentral body240 ofimplant200 is configured to be disposed in a space between a first spinous process SP1 and a second spinous process SP2 such that theouter surface241 of thecentral body240 can engage a first spinous process SP1 and a second spinous process SP2, either directly or through surrounding tissue. Said another way, at least during spinal extension, theouter surface241 of thecentral body240 is configured to directly engage and/or contact the spinous processes SP1, SP2 and/or the bodily tissue surrounding the spinous processes SP1, SP2 without any intervening structure associated with theimplant200. In some embodiments, for example, a portion of thecentral body240 is disposed within an opening defined in the interspinous ligament (not shown). In this manner, thecentral body240 can contact the spinous processes SP1, SP2 through the interspinous ligament. For purposes of clarity, however, the tissue surrounding the spinous processes SP1, SP2 is not illustrated.
• Theproximal retention member260 of theimplant200 includes anouter surface261 and anengagement surface263. Theengagement surface263 is substantially normal to the longitudinal axis A_Land is slidably coupled to theproximal surface242 of thecentral body240. Accordingly, theproximal retention member260 can translate relative to thecentral body240 between a first position and a second position corresponding to a first configuration of theimplant200 and a second configuration of theimplant200, respectively, as described in further detail herein. Theengagement surface263 of theproximal retention member260 is substantially parallel to theproximal surface242 of thecentral body240. Said another way, the angle that theengagement surface263 defines with respect to the longitudinal axis A_Lis supplementary to the angle defined by theproximal surface242 of thecentral body240 with respect to the longitudinal axis A_L.
• Thedistal retention member220 of theimplant200 includes anouter surface221 and anengagement surface223. Theengagement surface223 is substantially normal to the longitudinal axis A_Land is slidably coupled to thedistal surface243 of thecentral body240. Accordingly, thedistal retention member220 can translate relative to thecentral body240 between a first position and a second position corresponding to the first configuration of theimplant200 and the second configuration of theimplant200, respectively, as described in further detail herein. Theengagement surface223 of thedistal retention member220 is substantially parallel to thedistal surface243 of thecentral body240. Said another way, the angle that theengagement surface223 defines with respect to the longitudinal axis A_Lis supplementary to the angle defined by thedistal surface243 of thecentral body240 with respect to the longitudinal axis A_L.
• As shown inFIGS. 3 and 4, theimplant200 is movable between a first configuration (FIG. 3) and a second configuration (FIG. 4). When theimplant200 is in the first configuration, theouter surface221 of thedistal retention member220, theouter surface261 of theproximal retention member260 and theouter surface241 of thecentral body240 are substantially aligned. Said another way, theouter surface221 of thedistal retention member220, theouter surface261 of theproximal retention member260 and theouter surface241 of thecentral body240 form a substantially continuous surface. Said yet another way, theouter surface221 of thedistal retention member220 and theouter surface261 of theproximal retention member260 are flush with theouter surface241 of thecentral body240.
• To move theimplant200 to the second configuration, theproximal retention member260 and thedistal retention member220 are moved from their first positions to their second positions by moving them in the direction shown by the arrow CCC inFIG. 4. More particularly, theproximal retention member260 and thedistal retention member220 translate relative to thecentral body240. Said another way, theproximal retention member260 and thedistal retention member220 move in a direction substantially normal to the longitudinal axis A_L. Said yet another way, theproximal retention member260 and thedistal retention member220 slide along theproximal surface242 of thecentral body240 and thedistal surface243 of thecentral body240, respectively. In some embodiments, theproximal retention member260 and thedistal retention member220 can be moved, for example, by a tool configured to engage theproximal retention member260 and/or thedistal retention member220. In some embodiments, theimplant200 can include actuators, similar toactuator111 of theimplant100, to move theproximal retention member260 and thedistal retention member220 between their respective first positions and their second positions.
• When theimplant200 is in the second configuration, thedistal retention member220 and theproximal retention member260 are offset from thecentral body240 in a direction normal to the longitudinal axis A_L. Said another way, at least a portion of theouter surface221 of thedistal retention member220 and at least a portion of theouter surface261 of theproximal retention member260 are spaced apart from theouter surface241 of thecentral body240 by a distance D4. In this manner, thedistal retention member220, theproximal retention member260 and thecentral member240 form a saddle, as further described herein.
• In use, theimplant200 can be inserted between a first spinous process SP1 and a second spinous process SP2 when theimplant200 is in the first configuration (see e.g.,FIG. 3). For example, a medical practitioner can insert theimplant200 percutaneously (e.g., through a cannula, over a guide wire, or the like) into a body of a patient. In some embodiments, a tool, such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety, can be used to insert theimplant200 into a body of a patient.
• After theimplant200 is between the first spinous process SP1 and the second spinous process SP2, theimplant200 can be moved from the first configuration to the second configuration (see e.g.,FIG. 4). In some embodiments, theimplant200 can be actuated using a tool (not shown) configured to move thedistal retention member220 and theproximal retention member260 relative to thecentral body240 when theimplant200 is within the body. Such tools can be configured to maintain thecentral body240 in a fixed position while exerting a force on thedistal retention member220 and/or theproximal retention member260. Such tools can include, for example, those tools described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for Insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. As stated above, when theimplant200 is in the second configuration, thedistal retention member220, theproximal retention member260 and thecentral body240 form a saddle, within which the first spinous process SP1 is disposed. In this manner, when theimplant200 is in the second configuration thedistal retention member220 and theproximal retention member260 can collectively limit movement of thecentral body240 with respect to the first spinous process SP1.
• A medical practitioner can remove from and/or reposition theimplant200 within the body multiple times. To remove from and/or reposition theimplant200 within the body, theimplant200 can be moved from the second configuration to the first configuration. This can be done by moving thedistal retention member220 and theproximal retention member260 to their first positions and thus theimplant200 to its first configuration. After theimplant200 is in the first configuration, the medical practitioner can remove from and/or reposition theimplant200 within the body.
• In some embodiments, thedistal retention member220 can include a tapered portion to facilitate insertion of theimplant200 into the body. More particularly, the tapered portion can distract, dilate and/or pierce a bodily tissue. In some embodiments, for example, the tapered portion can pierce a bodily tissue, such as the interspinous ligament, when theimplant200 is inserted into the body. In some embodiments, the tapered portion can dilate a bodily tissue, such as the interspinous ligament, when theimplant200 is inserted into the body. In some embodiments, the tapered portion can distract a space between adjacent spinous processes when theimplant200 is inserted into the body.
• FIGS. 5 and 6 are schematic illustrations of animplant300, according to an embodiment, in a first configuration and a second configuration, respectively. Theimplant300 includes aspacer340, afirst retention member320, asecond retention member330 and anactuator311. Thespacer340 includes aside surface343, anouter surface341, and defines a longitudinal axis A_L. At least a portion of thespacer340 ofimplant300 is configured to be disposed in a space between a first spinous process SP1 and a second spinous process SP2 such that theouter surface341 of thespacer340 can engage a first spinous process SP1 and a second spinous process SP2, either directly or through surrounding tissue. Said another way, at least during spinal extension, theouter surface341 of thespacer340 is configured to directly engage and/or contact the spinous processes SP1, SP2 and/or the bodily tissue surrounding the spinous processes SP1, SP2 without any intervening structure associated with theimplant300. In some embodiments, for example, a portion of thespacer340 is disposed within an opening defined in the interspinous ligament (not shown). In this manner, thespacer340 can contact the spinous processes SP1, SP2 through the interspinous ligament. For purposes of clarity, however, the tissue surrounding the spinous processes SP1, SP2 is not illustrated.
• Thefirst retention member320 of theimplant300 includes afirst surface322, asecond surface323, and anouter surface321. Thesecond surface323 of thefirst retention member320 is slidably coupled to theside surface343 of thespacer340. In this manner, thefirst retention member320 can move with respect to thespacer340. Thesecond surface323 of thefirst retention member320 is substantially normal to the longitudinal axis A_Land is substantially parallel to theside surface343 of thespacer340. Said another way, thesecond surface323 of thefirst retention member320 has an angle with respect to the longitudinal axis A_Lthat is supplementary to the angle defined by theside surface343 of thespacer340 and the longitudinal axis A_L.
• Thefirst surface322 of thefirst retention member320 is substantially parallel to thefirst actuation surface316 of theactuator311. An axis A_P1defined by a plane within thefirst surface322 of thefirst retention member320 is non-parallel to and non-normal to the longitudinal axis A_L. Said another way, thefirst surface322 of thefirst retention member320 is angularly offset from the longitudinal axis A_Lby an angle θ₃. The angle θ₃, which is defined by thefirst surface322 of thefirst retention member320 and the longitudinal axis A_L, is supplementary to the angle θ₄defined by thefirst actuation surface316 of theactuator311 and the longitudinal axis A_L.
• Thesecond retention member330 of theimplant300 includes afirst surface332, asecond surface333, and anouter surface331. Thesecond surface333 of thesecond retention member330 is slidably coupled to theside surface343 of thespacer340. In this manner, thesecond retention member330 can move with respect to thespacer340. Thesecond surface333 of thesecond retention member330 is substantially normal to the longitudinal axis A_Land is substantially parallel to theside surface343 of thespacer340. Said another way, thesecond surface333 of thesecond retention member330 has an angle with respect to the longitudinal axis A_Lthat is supplementary to the angle defined by theside surface343 of thespacer340 and the longitudinal axis A_L.
• Thefirst surface332 of thesecond retention member330 is substantially parallel to thesecond actuation surface317 of theactuator311. An axis A_P2within a plane defined by thefirst surface332 of thesecond retention member330 is non-parallel to and non-normal to the longitudinal axis A_L. Said another way, thefirst surface332 of thesecond retention member330 is angularly offset from the longitudinal axis A_Lby an angle θ₅. The angle θ₅, which is defined by thefirst surface332 of thesecond retention member330 and the longitudinal axis A_L, is supplementary to the angle θ₆defined by thesecond actuation surface317 of theactuator311 and the longitudinal axis A_L.
• Theactuator311 of theimplant300 includes a taperedportion305 having afirst actuation surface316 and asecond actuation surface317. As stated above, thefirst actuation surface316 is substantially parallel to thefirst surface322 of thefirst retention member320. Similarly, thesecond actuation surface317 is substantially parallel to thefirst surface332 of thesecond retention member330. As described above, the angle θ₄, which is defined by thefirst actuation surface316 of theactuator311 and the longitudinal axis A_L, is supplementary to the angle θ₃, which is defined by thefirst surface322 of thefirst retention member320 and the longitudinal axis A_L. Similarly, the angle θ₆, which is defined by thesecond actuation surface317 of theactuator311 and the longitudinal axis A_L, is supplementary to the angle θ₅, which is defined by thefirst surface332 of thesecond retention member330 and the longitudinal axis A_L.
• As shown inFIGS. 5 and 6, theimplant300 is movable between a first configuration (FIG. 5) and a second configuration (FIG. 6). When theimplant300 is in the first configuration, theactuator311 is spaced apart from theside surface343 of thespacer340 along the longitudinal axis A_Lby a distance D5. When theimplant300 is in the first configuration, theouter surface321 of thefirst retention member320 and theouter surface331 of thesecond retention member330 are substantially aligned with theouter surface341 of thespacer340. Said another way, theouter surface321 of thefirst retention member320 and theouter surface341 of thespacer340 form a substantially continuous surface. Similarly, theouter surface331 of thesecond retention member330 and theouter surface341 of thespacer340 form a substantially continuous surface. Said yet another way, theouter surface321 of thefirst retention member320 is substantially flush with theouter surface341 of thespacer340. Similarly, theouter surface331 of thesecond retention member330 is substantially flush with theouter surface341 of thespacer340. Said still another way, thesecond surface323 of thefirst retention member320 and thesecond surface333 of thesecond retention member330 are aligned with theside surface343 of thespacer340.
• To move theimplant300 to the second configuration, theactuator311 is moved along the longitudinal axis A_Lin the direction shown by the arrow DDD inFIG. 6. Movement of theactuator311 causes thefirst actuation surface316 of theactuator311 to exert an axial force on thefirst surface322 of thefirst retention member320. As described above, because thefirst actuation surface316 of theactuator311 is at an angle θ₄with respect to the longitudinal axis A_L, a component of the axial force transmitted via thefirst actuation surface316 to thefirst surface322 of thefirst retention member320 has a direction as shown by the arrow EEE inFIG. 6. Accordingly, the force exerted by theactuator311 on thefirst retention member320 causes thefirst surface322 of thefirst retention member320 to slide on thefirst actuation surface316 of theactuator311, and causes thefirst retention member320 to move in the direction shown by the arrow EEE inFIG. 6.
• Similarly, movement of theactuator311 in the direction shown by the arrow DDD inFIG. 6 causes thesecond actuation surface317 of the actuator to exert an axial force on thefirst surface332 of thesecond retention member330. Because thesecond actuation surface317 of theactuator311 is at an acute angle θ₆with respect to the longitudinal axis A_L, a component of the axial force transmitted via thesecond actuation surface317 to thefirst surface332 of thesecond retention member330 has a direction as shown by the arrow FFF inFIG. 6. Accordingly, the force exerted by theactuator311 on thesecond retention member330 causes thefirst surface332 of thesecond retention member330 to slide on thesecond actuation surface317 of theactuator311, and causes thesecond retention member330 to move in the direction shown by the arrow FFF inFIG. 6. Similar to implant100 described above, the values of the angles θ₃, θ₄, θ₅, θ₆, influence the force to move theimplant300 from the first configuration to the second configuration and the distance theactuator311 travels to move theimplant300 from the first configuration to the second configuration.
• As shown inFIG. 6, when theimplant300 is in the second configuration, theactuator311 is spaced apart from theside surface343 of thespacer340 along the longitudinal axis A_Lby a distance D6, which is less than D5. Although shown inFIG. 6 as being spaced apart by the distance D6, in other embodiments, theactuator311 can be in contact with theside surface343 of thespacer340 when theimplant300 is in the second configuration. In such embodiments, after theactuator311 moves a predetermined distance along the longitudinal axis A_L, theactuator311 can contact thespacer340, limiting the range of motion of theactuator311 relative to thespacer340.
• When theimplant300 is in the second configuration, thefirst retention member320 is offset from thespacer340 in a direction substantially normal to the longitudinal axis A_L, as shown by arrow EEE inFIG. 6. Said another way, theouter surface321 of thefirst retention member320 is spaced apart from theouter surface341 of thespacer340 by a distance D7. Similarly, thesecond retention member330 is offset from thespacer340 in a direction normal to the longitudinal axis A_L, as shown by arrow FFF inFIG. 6. Said another way, theouter surface331 of thesecond retention member330 is spaced apart from theouter surface341 of thespacer340 by a distance D8. Said yet another way, theouter surface321 of thefirst retention member320 and theouter surface331 of thesecond retention member330 are not aligned with theouter surface341 of thespacer340 and are discontinuous with theouter surface341 of thespacer340.
• In use, theimplant300 can be inserted between a first spinous process SP1 and a second spinous process SP2 when theimplant300 is in the first configuration (see e.g.,FIG. 5). For example, a medical practitioner can insert theimplant300 percutaneously (e.g., through a cannula, over a guide wire, or the like) into a body of a patient. In some embodiments, a tool, such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety, can be used to insert theimplant300 into a body of a patient.
• After theimplant300 is between the first spinous process SP1 and the second spinous process SP2, theimplant300 can be moved from the first configuration to the second configuration (see e.g.,FIG. 6). In some embodiments, theimplant300 can be actuated using a tool (not shown) configured to move theactuator311 relative to thespacer340 when theimplant300 is within the body. Such tools can be configured to maintain thespacer340 in a fixed position while exerting a force on theactuator311. Such tools can include, for example, those tools described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for Insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. When theimplant300 is in the second configuration, thefirst retention member320 and thesecond retention member330 limit the movement of theimplant300 in the direction shown by arrow DDD inFIG. 6, with respect to the first spinous process SP1 and the second spinous process SP2.
• A medical practitioner can remove from and/or reposition theimplant300 within the body multiple times. To remove from and/or reposition theimplant300 within the body, theimplant300 is moved from the second configuration to the first configuration. This can be done by moving thefirst retention member320 and the second retention member360 to their first positions and thus theimplant300 to its first configuration. After theimplant300 is in the first configuration, the medical practitioner can remove from and/or reposition theimplant300 within the body.
• In some embodiments, the actuator can have a second tapered portion to facilitate insertion of theimplant300 into the body. More particularly, the second tapered portion can distract, dilate and/or pierce bodily tissue. In some embodiments, for example, the second tapered portion can pierce a bodily tissue, such as an interspinous ligament, when theimplant300 is inserted into the body. In some embodiments, the second tapered portion can dilate a bodily tissue, such as the interspinous ligament, when theimplant300 is inserted into the body. In some embodiments, the second tapered portion can distract a space between adjacent spinous processes when theimplant300 is inserted into the body.
• In some embodiments, angle θ₃does not equal angle θ₅. In such an embodiment, when theimplant300 is in the second configuration, theouter surface321 of thefirst retention member320 and theouter surface331 of thesecond retention member330 are spaced apart from theouter surface341 by unequal distances. Accordingly, if angle θ₃is greater than angle θ₅, theouter surface331 of thesecond retention member330 will be spaced further apart from theouter surface341 of thespacer340 than theouter surface321 of thefirst retention member320. Said another way, distance D8 is greater than distance D7.
• FIGS. 7-13 show animplant1100, according to an embodiment.Implant1100 includes adistal end portion1110, acentral portion1140 and aproximal end portion1180. At least a portion of thecentral portion1140 is disposed between thedistal end portion1110 and theproximal end portion1180. Theimplant1100 defines alumen1146 and includes adrive screw1183 disposed within thelumen1146.Drive screw1183 has atool head1184 configured to mate with and/or receive an actuator of an insertion tool for rotating thedrive screw1183, as described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety.
• Distal end portion1110 ofimplant1100 includes anactuator1111 and adistal retention member1120.Actuator1111 includes a taperedsurface1112, a threaded portion1114 (seeFIG. 12), anengagement surface1116, and aprotrusion1118. The threadedportion1114 is disposed fixedly within thelumen1146 and is configured to receive thedrive screw1183. In other embodiments, theactuator1111 can include a captive nut configured to receive thedrive screw1183.
• Theengagement surface1116 of theactuator1111 is angularly offset from the longitudinal axis A_Lof theimplant1100 by an angle between 0 degrees and 90 degrees. Said another way, theengagement surface1116 of theactuator1111 is angularly offset from the longitudinal axis A_Lof theimplant1100 by an acute angle. As described above, the angular offset of theengagement surface1116 is associated with moving theimplant1100 between a first configuration (FIG. 7) and a second configuration (FIG. 8).
• Theprotrusion1118 of theengagement surface1116 has an undercut such that thedistal retention member1120 is slidably coupled to theactuator1111. More particularly, theprotrusion1118 has a trapezoidal cross-sectional shape. In this embodiment, theprotrusion1118 is a dovetail protrusion.
• Distal retention member1120 includes anouter surface1121, afirst engagement surface1122, and asecond engagement surface1123 opposite thefirst engagement surface1122. Thedistal retention member1120 defines a notch1128 (seeFIG. 11) configured to allow thedrive screw1183 to pass through thedistal retention member1120 when theimplant1100 is in the first configuration. Said another way, when theimplant1100 is in the first configuration, thenotch1128 is aligned with thelumen1146.
• Thefirst engagement surface1122 of thedistal retention member1120 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant1100 by an angle between 90 degrees and 180 degrees. Said another way, thefirst engagement surface1122 of thedistal retention member1120 defines a plane that is angularly offset from the longitudinal axis A_Lby an obtuse angle. Moreover, thefirst engagement surface1122 of thedistal retention member1120 is substantially parallel to theengagement surface1116 of theactuator1111. Said another way, the angular offset of thefirst engagement surface1122 of thedistal retention member1120 is supplementary with the angular offset of theengagement surface1116 of theactuator1111. Accordingly, thedistal retention member1120 is slidably disposed againstactuator1111.
• Thefirst engagement surface1122 of thedistal retention member1120 defines afirst groove1124 having a trapezoidal cross-sectional shape. In this embodiment, thefirst groove1124 has a dovetail shape that corresponds to the shape of theprotrusion1118 of theactuator1111. Thefirst groove1124 is configured to slidingly receive theprotrusion1118 of theactuator1111. The undercut of theprotrusion1118 of theactuator1111 slidably maintains theprotrusion1118 of theactuator1111 within thefirst groove1124. Thefirst groove1124 of thefirst engagement surface1122 and theprotrusion1118 of theactuator1111 collectively allow movement of thedistal retention member1120, with respect to theactuator1111, in a direction substantially parallel to thefirst engagement surface1122 of thedistal retention member1120. Moreover, thefirst groove1124 of thefirst engagement surface1122 and theprotrusion1118 of theactuator1111 collectively limit movement of thedistal retention member1120, with respect to theactuator1111, in a direction substantially normal to thefirst engagement surface1122 of thedistal retention member1120. Thefirst engagement surface1122 of thedistal retention member1120 contacts and is configured to slide along theengagement surface1116 of theactuator1111 when thefirst groove1124 slides about theprotrusion1118 of theactuator1111. In this manner, thefirst groove1124 and theprotrusion1118 collectively maintain theactuator1111 in sliding contact with thedistal retention member1120.
• Thesecond engagement surface1123 of thedistal retention member1120 is substantially parallel to thedistal engagement surface1143 of thecentral portion1140 and defines a plane substantially normal to the longitudinal axis A_Lof theimplant1100. Thesecond engagement surface1123 of thedistal retention member1120 defines asecond groove1126. Thesecond groove1126 has a shape that corresponds to the shape of thedistal protrusion1145 of thecentral portion1140. Thesecond engagement surface1123 of thedistal retention member1120 is slidably disposed against and/or coupled to thecentral portion1140 of theimplant1100, as described in more detail herein.
• Proximal end portion1180 ofimplant1100 includes atool engagement member1182 and aproximal retention member1160.Tool engagement member1182 is configured to mate with and/or receive an insertion tool, as described in more detail below.Tool engagement member1182 includes anengagement surface1186 and aprotrusion1188. Theengagement surface1186 of thetool engagement member1182 is angularly offset from the longitudinal axis A_Lof theimplant1100 by an angle between 0 degrees and 90 degrees. Said another way, theengagement surface1186 of thetool engagement member1182 is angularly offset from the longitudinal axis A_Lof theimplant1100 by an acute angle. As described above, the angular offset of theengagement surface1186 is associated with moving theimplant1100 between a first configuration (FIG. 7) and a second configuration (FIG. 8).
• Theprotrusion1188 of theengagement surface1186 has an undercut such that theproximal retention member1160 can be slidably coupled to thetool engagement member1182. More particularly, theprotrusion1188 has a trapezoidal cross-sectional shape. In some embodiments, theprotrusion1188 is a dovetail protrusion.
• Proximal retention member1160 includes anouter surface1161, afirst engagement surface1162, and asecond engagement surface1163 opposite thefirst engagement surface1162. Theproximal retention member1160 defines a notch1168 (seeFIG. 11) configured to allow thedrive screw1183 to pass through theproximal retention member1160 when theimplant1100 is in the first configuration. Said another way, when theimplant1100 is in the first configuration, thenotch1168 is aligned with thelumen1146.
• Thefirst engagement surface1162 of theproximal retention member1160 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant1160 by an angle between 90 degrees and 180 degrees. Thefirst engagement surface1162 of theproximal retention member1160 is substantially parallel to theengagement surface1186 of thetool engagement member1182. Said another way, the angular offset of thefirst engagement surface1162 of theproximal retention member1160 is supplementary with the angular offset of theengagement surface1186 of thetool engagement member1182. Accordingly, theproximal retention member1160 is slidably disposed against thetool engagement member1182.
• Moreover, thefirst engagement surface1162 of theproximal retention member1160 defines afirst groove1164 having a trapezoidal cross-sectional shape. In this embodiment, thefirst groove1164 has a dovetail shape that corresponds to the shape of theprotrusion1188 of thetool engagement member1182. Thefirst groove1164 is configured to slidably receive theprotrusion1188 of thetool engagement member1182. The undercut of theprotrusion1188 of thetool engagement member1182 maintains theprotrusion1188 of thetool engagement member1182 within thefirst groove1164. Thefirst groove1164 of thefirst engagement surface1162 and theprotrusion1188 of thetool engagement member1182 collectively allow movement of theproximal retention member1160, with respect to thetool engagement member1182, in a direction substantially parallel to thesecond engagement surface1163 of theproximal retention member1160. Moreover, thefirst groove1164 of thefirst engagement surface1162 and theprotrusion1188 of thetool engagement member1182 collectively limit movement of theproximal retention member1160, with respect to thetool engagement member1182, in a direction substantially normal to thesecond engagement surface1163 of theproximal retention member1160. Thefirst engagement surface1162 of theproximal retention member1160 contacts and is configured to slide along theengagement surface1186 of thetool engagement member1182 when thefirst groove1164 of theproximal retention member1160 slides along theprotrusion1188 of thetool engagement member1182. In this manner, thefirst groove1164 and theprotrusion1188 collectively maintain thetool engagement member1182 in sliding contact with theproximal retention member1160.
• Thesecond engagement surface1163 of theproximal retention member1160 is substantially parallel to theproximal engagement surface1142 of thecentral portion1140 and defines a plane substantially normal to the longitudinal axis A_Lof theimplant1100. In other embodiments, however, the plane defined by thesecond engagement surface1163 of theproximal retention member1160 can be angularly offset from the longitudinal axis A_Lof theimplant1100 by an angle other than 90 degrees. Moreover, thesecond engagement surface1163 of theproximal retention member1160 defines asecond groove1166. Thesecond groove1166 has a shape that corresponds to the shape of theproximal protrusion1144 of thecentral portion1140. Thesecond engagement surface1163 of theproximal retention member1160 is slidably disposed against and/or coupled to thecentral portion1140 of theimplant1100, as described in more detail herein.
• Thecentral portion1140 ofimplant1100 includes aproximal engagement surface1142, adistal engagement surface1143, aproximal protrusion1144, adistal protrusion1145 and anouter surface1141. Thedistal retention member1120 is slidably coupled to thecentral portion1140. More particularly, thesecond groove1126 of thedistal retention member1120 is configured to slidingly receive thedistal protrusion1145 of thecentral portion1140. Thesecond engagement surface1123 of thedistal retention member1120 contacts and is configured to slide along thedistal engagement surface1143 of thecentral portion1140 when thesecond groove1126 of thedistal retention member1120 slides along thedistal protrusion1145 of thecentral portion1140.
• Similarly, theproximal retention member1160 is slidably coupled to thecentral portion1140. Thesecond groove1166 of theproximal retention member1160 is configured to slidingly receive theproximal protrusion1144 of thecentral portion1140. Theproximal protrusion1144 of thecentral portion1140 is slidably maintained within thesecond groove1166 of theproximal retention member1160. Thesecond engagement surface1163 of theproximal retention member1160 contacts and is configured to slide along theproximal engagement surface1142 of thecentral portion1140 when thesecond groove1166 of theproximal retention member1160 slides along theproximal protrusion1144 of thecentral portion1140.
• Implant1100 has a first configuration (FIG. 7) and a second configuration (FIG. 8). As shown inFIG. 7, when theimplant1100 is in the first configuration, theproximal end portion1180, thedistal end portion1110 and thecentral portion1140 are substantially coaxial (i.e., substantially share a common longitudinal axis). Said another way, when theimplant1100 is in the first configuration, theouter surface1121 of thedistal retention member1120 and theouter surface1161 of theproximal retention member1160 are substantially aligned with theouter surface1141 of thecentral portion1140. Said another way, theouter surface1121 of thedistal retention member1120, theouter surface1161 of theproximal retention member1160, and theouter surface1141 of thecentral portion1140 form a substantially continuous surface. Said yet another way, theouter surface1121 of thedistal retention member1120 and theouter surface1161 of theproximal retention member1160 are flush with theouter surface1141 of thecentral portion1140.
• Theimplant1100 can be moved between the first configuration and the second configuration as illustrated inFIG. 8. To move theimplant1100 from the first configuration to the second configuration, thedrive screw1183 is rotated as indicated by the arrow CC inFIG. 7. When thedrive screw1183 is rotated, thedrive screw1183 moves theactuator1111 and thetool engagement member1182 toward thecentral portion1140. More particularly, when thedrive screw1183 is rotated, theengagement surface1116 of theactuator1111 exerts an axial force on thefirst engagement surface1122 of thedistal retention member1120. Because theengagement surface1116 of theactuator1111 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via theengagement surface1116 to thefirst engagement surface1122 of thedistal retention member1120 has a direction as shown by the arrow AA inFIG. 8. Said another way, a component of the force exerted by theactuator1111 on thedistal retention member1120 has a direction that is substantially normal to the longitudinal axis A_L. This force causes thedistal retention member1120 to slide on theengagement surface1116 of theactuator1111 causing thedistal retention member1120 to move in the direction AA and into the second configuration. Once thedistal retention member1120 slides on theengagement surface1116 of the actuator1111 a predetermined distance, a portion of theengagement surface1116 of the actuator1111 contacts a portion of thedistal engagement surface1143 of the central portion1140 (see e.g.,FIG. 9) preventing thedistal retention member1120 from sliding further.
• Similarly, when thedrive screw1183 is rotated as indicated by the arrow CC inFIG. 7, theengagement surface1186 of thetool engagement member1182 exerts an axial force on thefirst engagement surface1162 of theproximal retention member1160. Because theengagement surface1186 of thetool engagement member1182 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via theengagement surface1186 to thefirst engagement surface1162 of theproximal retention member1160 has a direction as shown by the arrow AA inFIG. 8. Said another way, a component of the force exerted by thetool engagement member1182 on theproximal retention member1160 has a direction that is substantially normal to the longitudinal axis A_L. This force causes theproximal retention member1160 to slide on theengagement surface1186 of thetool engagement member1182 causing theproximal retention member1160 to move in the direction AA and into the second configuration. Once theproximal retention member1160 slides on theengagement surface1186 of the tool engagement member1182 a predetermined distance, a portion of theengagement surface1186 of thetool engagement member1182 contacts theproximal engagement surface1142 of thecentral portion1140 preventing theproximal retention member1160 from sliding further.
• When theimplant1100 is in the second configuration thedistal retention member1120 and/or theproximal retention member1160 are offset from thecentral portion1140 in a direction substantially normal to the longitudinal axis A_L. Said another way, theouter surface1121 of thedistal retention member1120 and/or theouter surface1161 of theproximal retention member1160 are not aligned with theouter surface1141 of thecentral portion1140 and are discontinuous with theouter surface1141 of thecentral portion1140.
• In use,implant1100 in the first configuration, is inserted percutaneously between a pair of adjacent spinous processes (not shown inFIGS. 7-13). For example, a medical practitioner can insert theimplant1100 percutaneously (e.g., through a cannula, over a guide wire, or the like) into a body of a patient. In some embodiments, an insertion tool such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety, can be used to insert theimplant1100 into a body of a patient. The insertion tool can be configured to be removably coupled to thetool engagement member1182 such that rotation of thetool engagement member1182 relative to the insertion tool about the longitudinal axis A_Lis limited. In some embodiments, the insertion tool can be configured to be removably coupled to thetool engagement member1182 such that axial movement of thetool engagement member1182 relative to the insertion tool is limited. In some embodiments, for example, the insertion tool can be coupled to an outer surface of thetool engagement member1182. In such embodiments, the outer surface of thetool engagement member1182 can be configured to facilitate the docking of the insertion tool (not shown) to theimplant1100. For example, in some embodiments, the outer surface of thetool engagement member1182 can include a lead-in chamfer, a tapered portion and/or a beveled edge to facilitate the docking of the insertion tool onto thetool engagement member1182 of theimplant1100. In other embodiments, the insertion tool can be matingly coupled to a protrusion and/or a recess of the tool engagement member. The insertion tool can include an actuator configured to be inserted into thetool head1184 of thedrive screw1183 to rotate thedrive screw1183 about the longitudinal axis A_L. This arrangement allows thedrive screw1183 to be rotated without rotating the other portions of theimplant1100.
• When inserting theimplant1100 into a body of a patient, thedistal end portion1110 of theimplant1100 is inserted first and is moved past the spinous processes until at least a portion of thecentral portion1140 is positioned within a space between the spinous processes. In this manner, thecentral portion1140 of theimplant1100 can distract and/or maintain a minimal spacing between the adjacent spinous processes. The distance between the top portion and the bottom portion of theouter surface1141 of thecentral portion1140 can be slightly smaller than the space between the spinous processes to account for surrounding ligaments and tissue. Similar to thecentral portion140 ofimplant100, in some embodiments, thecentral portion1140 in the first configuration directly contacts the spinous processes between which it is positioned. In some embodiments, thecentral portion1140 ofimplant1100 is a relatively fixed size and is not substantially compressible or expandable.
• Once between the spinous processes, theimplant1100 can be moved from the first configuration to the second configuration. As described above, theimplant1100 can be moved between the first configuration and the second configuration in situ using an insertion tool. In the second configuration, theproximal retention member1160 and thedistal retention member1120 are offset from thecentral portion1140 and positioned to limit lateral movement of theimplant1100 with respect to the spinous processes. Theproximal retention member1160 and thedistal retention member1120 are configured to engage the superior spinous process (i.e., either directly or through surrounding tissue) and/or be adjacent to the superior spinous process when in the second configuration. Said another way, thedistal retention member1120, theproximal retention member1160 and thespacer1140 form a saddle, within which a spinous process can be disposed. Once theimplant1100 is in the second configuration, theimplant1100 can be released from the insertion tool and the insertion tool can be removed from the patient's body. Although described as engaging the superior spinous process, in other embodiments, theimplant1100 can be oriented within the body such that theproximal retention member1160 and thedistal retention member1120 engage the inferior spinous process when actuated.
• To remove from and/or reposition theimplant1100 within the body, thedrive screw1183 is rotated as indicated by the arrow DD inFIG. 7, by for example, a removal tool (may be similar to an insertion tool). Rotating the drive screw in direction DD causes the dovetail configuration of theprotrusion1118 of theactuator1111 and/or the dovetail configuration of theprotrusion1188 of thetool engagement member1182 to pull thedistal retention member1120 and theproximal retention member1160 back into the first configuration. After theimplant1100 is in the first configuration, a medical practitioner can remove theimplant1100 from and/or reposition theimplant1100 within the body.
• FIGS. 14-21 show animplant2100, according to an embodiment.Implant2100 includes adistal end portion2110, acentral portion2140 and aproximal end portion2180. At least a portion of thecentral portion2140 is disposed between thedistal end portion2110 and theproximal end portion2180. Theimplant2100 defines a lumen2146 (see e.g.,FIGS. 20 and 21) and includes adrive screw2183 disposed within thelumen2146.Drive screw2183 has atool head2184 configured to mate with and/or receive a tool for rotating thedrive screw2183, as further described herein.
• Thedistal end portion2110 ofimplant2100 includes anactuator2111 and adistal retention member2120.Actuator2111 includes a taperedsurface2112, a threaded portion2114 (seeFIG. 16), and anengagement surface2116. The threadedportion2114 is disposed fixedly within thelumen2146 and is configured to receive thedrive screw2183, as described above. Theengagement surface2116 of theactuator2111 is angularly offset from the longitudinal axis A_Lof theimplant2100 by an angle between 0 degrees and 90 degrees. As described in more detail herein, the angular offset of theengagement surface2116 is associated with moving theimplant2100 between a first configuration (FIG. 14) and a second configuration (FIG. 17). Theengagement surface2116 includes aprotrusion2118 having an undercut such that thedistal retention member2120 can be coupled to theactuator2111. More particularly, theprotrusion2118 has a trapezoidal cross-sectional shape. In some embodiments, theprotrusion2118 is a dovetail protrusion.
• Distal retention member2120 includes anouter surface2121, afirst engagement surface2122, and asecond engagement surface2123 opposite thefirst engagement surface2122. Thedistal retention member2120 defines a notch2128 (seeFIG. 19) configured to allow thedrive screw2183 to pass through thedistal retention member2120 when theimplant2100 is in the first configuration. Thefirst engagement surface2122 of thedistal retention member2120 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant2100 by an angle between 90 degrees and 180 degrees. Moreover, thefirst engagement surface2122 of thedistal retention member2120 is substantially parallel to theengagement surface2116 of theactuator2111. Accordingly, thedistal retention member2120 is slidably disposed againstactuator2111.
• Thefirst engagement surface2122 of thedistal retention member2120 defines afirst groove2124 having a trapezoidal cross-sectional shape. In this embodiment, thefirst groove2124 has a dovetail shape that corresponds to the shape of theprotrusion2118 of theactuator2111. Thefirst groove2124 of thefirst engagement surface2122 and theprotrusion2118 of theactuator2111 collectively allow movement of thedistal retention member2120, with respect to theactuator2111, in a direction substantially parallel to thesecond engagement surface2123 of thedistal retention member2120. Moreover, thefirst groove2124 of thefirst engagement surface2122 and theprotrusion2118 of theactuator2111 collectively limit movement of thedistal retention member2120, with respect to theactuator2111, in a direction substantially normal to thesecond engagement surface2123 of thedistal retention member2120. Thefirst engagement surface2122 of thedistal retention member2120 contacts and is configured to slide along theengagement surface2116 of theactuator2111 when thefirst groove2124 slides along theprotrusion2118 of theactuator2111.
• Thesecond engagement surface2123 of thedistal retention member2120 is substantially parallel to thedistal engagement surface2143 of thecentral portion2140 and defines a plane substantially normal to the longitudinal axis A_Lof theimplant2100. Thesecond engagement surface2123 of thedistal retention member2120 defines asecond groove2126 having a trapezoidal cross-sectional shape. In this embodiment, thesecond groove2126 has a dovetail shape that corresponds to the shape of thedistal protrusion2145 of thecentral portion2140. Thesecond groove2126 of thesecond engagement surface2123 and thedistal protrusion2145 of thecentral body2140 collectively limit movement of thedistal retention member2120, with respect to thecentral portion2140, in a direction substantially normal to thesecond engagement surface2123 of thedistal retention member2120. Thesecond engagement surface2123 of thedistal retention member2120 is slidably disposed against and/or coupled to thecentral portion2140 of theimplant2100, as described in more detail herein.
• As shown inFIGS. 18-19, thefirst engagement surface2122 of thedistal retention member2120 is non-parallel to thesecond engagement surface2123 of thedistal retention member2120. The mating protrusion and grooves, as discussed above, and the non-parallel arrangement of thefirst engagement surface2122 and thesecond engagement surface2123 collectively lock thedistal retention member2120 between theactuator2111 and thecentral body2140. Said another way, because thefirst groove2124 and theprotrusion2118 of theactuator2111 collectively limit movement of thedistal retention member2120, with respect to theactuator2111, in a direction substantially normal to thesecond engagement surface2123 and thesecond groove2126 and thedistal protrusion2145 of thecentral body2140 collectively limit movement of thedistal retention member2120, with respect to thecentral portion2140, in a direction substantially normal to thesecond engagement surface2123, thedistal retention member2120 cannot move unless theactuator2111 is moved. This arrangement prevents thedistal retention member2120 from becoming inadvertently decoupled from theactuator2111 and/or thecentral body2140.
• Proximal end portion2180 ofimplant2100 includes atool engagement member2182 and aproximal retention member2160.Tool engagement member2182 is configured to mate with and/or receive an insertion tool.Tool engagement member2182 includes anengagement surface2186 and ahex portion2185. Thehex portion2185 includes a hexagonal shaped outer surface configured to be matingly received within a portion of an insertion tool. In this manner, thehex portion2185 of thetool engagement member2182 can limit rotational motion of theimplant2100 about the longitudinal axis A_L, when theimplant2100 is coupled to an insertion tool. In some embodiments, the hexagonal shaped outer surface of thehex portion2185 can be configured to facilitate the docking of the insertion tool (not shown) onto thehex portion2185 of theimplant2100. For example, in some embodiments, the outer surface of thehex portion2185 can include a lead-in chamfer, a tapered portion and/or a beveled edge to facilitate the docking of the insertion tool onto thehex portion2185 of theimplant2100.
• Thehex portion2185 defines a threadedportion2190 configured to mate with and/or receive a corresponding threaded portion of an insertion tool (not shown). In some embodiments, for example, the threadedportion2190 can receive a portion of the threaded intermediate shaft1430 of the tool shown and described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. In this manner, the threadedportion2190 can limit axial movement of theimplant2100 with respect to the insertion tool when theimplant2100 is inserted into a body of a patient, as described in further detail below. Moreover, when the shaft of the insertion tool is coupled within the threadedportion2190, movement of thedrive screw2183 along the longitudinal axis relative to thetool engagement member2182 is limited. In this manner, the coupling of an insertion tool within the threadedportion2190 can prevent thedrive screw2183 from moving, thereby maintaining theimplant2100 in the first configuration. In other embodiments, the threadedportion2190 can include a retainer (e.g., a snap ring, an E-ring or the like) to prevent translation of thedrive screw2183 relative to thetool engagement member2182.
• Similar to theengagement surface1186 of thetool engagement member1182, theengagement surface2186 of thetool engagement member2182 is angularly offset from the longitudinal axis A_Lof theimplant2100 by an angle between 0 degrees and 90 degrees. Theengagement surface2186 includes aprotrusion2188 having an undercut such that theproximal retention member2160 can be coupled to thetool engagement member2182. More particularly, theprotrusion2188 has a trapezoidal cross-sectional shape. In this embodiment, theprotrusion2188 is a dovetail protrusion.
• Proximal retention member2160 includes anouter surface2161, afirst engagement surface2162, and asecond engagement surface2163 opposite thefirst engagement surface2162. Theproximal retention member2160 defines a notch2168 (seeFIG. 21) configured to allow thedrive screw2183 to pass through theproximal retention member2160 when theimplant2100 is in the first configuration. Thefirst engagement surface2162 of theproximal retention member2160 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant2160 by an angle between 90 degrees and 180 degrees. Moreover, thefirst engagement surface2162 of theproximal retention member2160 is substantially parallel to theengagement surface2186 of thetool engagement member2182. Accordingly, theproximal retention member2160 is slidably disposed against thetool engagement member2182.
• Thefirst engagement surface2162 of theproximal retention member2160 defines afirst groove2164 having a trapezoidal cross-sectional shape. In this embodiment, thefirst groove2164 has a dovetail shape that corresponds to the shape of theprotrusion2188 of thetool engagement member2182. The undercut of theprotrusion2188 of thetool engagement member2182 slidably maintains theprotrusion2188 of thetool engagement member2182 within thefirst groove2164. More particularly, thefirst groove2164 of thefirst engagement surface2162 and theprotrusion2188 of thetool engagement member2182 collectively allow movement of theproximal retention member2160, with respect to thetool engagement member2182, in a direction substantially parallel to thesecond engagement surface2163 of theproximal retention member2160. Moreover, thefirst groove2164 of thefirst engagement surface2162 and theprotrusion2188 of thetool engagement member2182 collectively limit movement of theproximal retention member2160, with respect to thetool engagement member2182, in a direction substantially normal to thesecond engagement surface2163 of theproximal retention member2160. Thefirst engagement surface2162 of theproximal retention member2160 contacts and is configured to slide along theengagement surface2186 of thetool engagement member2182 when thefirst groove2164 of theproximal retention member2160 slides along theprotrusion2188 of thetool engagement member2182.
• Thesecond engagement surface2163 of theproximal retention member2160 is substantially parallel to theproximal engagement surface2142 of thecentral portion2140 and defines a plane substantially normal to the longitudinal axis A_Lof theimplant2100. Thesecond engagement surface2163 of theproximal retention member2160 defines asecond groove2166 having a trapezoidal cross-sectional shape. In this embodiment, thesecond groove2166 has a dovetail shape that corresponds to the shape of theproximal protrusion2144 of thecentral portion2140. Thesecond groove2166 of thesecond engagement surface2163 and theproximal protrusion2144 of thecentral portion2140 collectively limit movement of theproximal retention member2160, with respect to thecentral body2140, in a direction substantially normal to thesecond engagement surface2163 of theproximal retention member2160. Thesecond engagement surface2163 of theproximal retention member2160 is slidably disposed against and/or coupled to thecentral portion2140 of theimplant2100, as described in more detail herein.
• As shown inFIGS. 18-19, thefirst engagement surface2162 of theproximal retention member2160 is non-parallel to thesecond engagement surface2163 of theproximal retention member2160. The mating protrusion and grooves, as discussed above, and the non-parallel arrangement of thefirst engagement surface2162 and thesecond engagement surface2163 collectively lock theproximal retention member2160 between thetool engagement member2182 and thecentral body2140. Said another way, because thefirst groove2164 and theprotrusion2188 of thetool engagement member2182 collectively limit movement of theproximal retention member2160, with respect to thetool engagement member2182, in a direction substantially normal to thefirst engagement surface2162 and thesecond groove2166 and theproximal protrusion2144 of thecentral body2140 collectively limit movement of theproximal retention member2160, with respect to thecentral portion2140, in a direction substantially normal to thesecond engagement surface2163, theproximal retention member2160 cannot move unless thetool engagement member2182 is moved. This arrangement prevents theproximal retention member2160 from becoming inadvertently decoupled from thetool engagement member2182 and/or thecentral body2140.
• Thecentral portion2140 ofimplant2100 includes aproximal engagement surface2142, adistal engagement surface2143, aproximal protrusion2144, adistal protrusion2145 and anouter surface2141. Thedistal retention member2120 is slidably coupled to thecentral portion2140. Thesecond groove2126 of thedistal retention member2120 is configured to slidingly receive thedistal protrusion2145 of thecentral portion2140. Thedistal protrusion2145 of thecentral portion2140 has a dovetail shape slidably maintaining it within thesecond groove2126 of thedistal retention member2120. Thesecond engagement surface2123 of thedistal retention member2120 contacts and is configured to slide along thedistal engagement surface2143 of thecentral portion2140 when thesecond groove2126 of thedistal retention member2120 slides along thedistal protrusion2145 of thecentral portion2140.
• Similarly, theproximal retention member2160 is slidably coupled to thecentral portion2140. Thesecond groove2166 of theproximal retention member2160 is configured to slidingly receive theproximal protrusion2144 of thecentral portion2140. Theproximal protrusion2144 of thecentral portion2140 has a dovetail shape slidably maintaining it within thesecond groove2166 of theproximal retention member2160. Thesecond engagement surface2163 of theproximal retention member2160 contacts and is configured to slide along theproximal engagement surface2142 of thecentral portion2140 when thesecond groove2166 of theproximal retention member2160 slides along theproximal protrusion2144 of thecentral portion2140.
• Theimplant2100 has a first configuration (FIG. 14) and a second configuration (FIG. 18). When theimplant2100 is in the first configuration, theproximal end portion2180, thedistal end portion2110 and thecentral portion2140 are substantially coaxial (i.e., substantially share a common longitudinal axis). As described above, theimplant2100 can be moved between the first configuration and the second configuration by rotating thedrive screw2183. When thedrive screw2183 is rotated as indicated by the arrow CC inFIG. 15, thedrive screw2183 moves theactuator2111 and thetool engagement member2182 toward thecentral portion2140. Theengagement surface2116 of theactuator2111 exerts an axial force on thefirst engagement surface2122 of thedistal retention member2120. Because theengagement surface2116 of theactuator2111 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via theengagement surface2116 to thefirst engagement surface2122 of thedistal retention member2120 has a direction as shown by the arrow AA inFIG. 18. Said another way, a component of the force exerted by theactuator2111 on thedistal retention member2120 has a direction that is substantially normal to the longitudinal axis A_L. This force causes thedistal retention member2120 to slide on theengagement surface2116 of theactuator2111 causing thedistal retention member2120 to move in the direction AA and into the second configuration. Once thedistal retention member2120 slides on theengagement surface2116 of the actuator2111 a predetermined distance, a portion of theengagement surface2116 of the actuator2111 contacts a portion of thedistal engagement surface2143 of thecentral portion2140 preventing thedistal retention member2120 from sliding further.
• Similarly, when thedrive screw2183 is rotated as indicated by the arrow CC inFIG. 15, theengagement surface2186 of thetool engagement member2182 exerts an axial force on thefirst engagement surface2162 of theproximal retention member2160. Because theengagement surface2186 of thetool engagement member2182 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via theengagement surface2186 to thefirst engagement surface2162 of theproximal retention member2160 has a direction as shown by the arrow AA inFIG. 18. Said another way, a component of the force exerted by thetool engagement member2182 on theproximal retention member2160 has a direction that is substantially normal to the longitudinal axis A_L. This force causes theproximal retention member2160 to slide on theengagement surface2186 of thetool engagement member2182 causing theproximal retention member2160 to move in the direction AA and into the second configuration. Once theproximal retention member2160 slides on theengagement surface2186 of the tool engagement member2180 a predetermined distance, a portion of theengagement surface2186 of thetool engagement member2180 contacts theproximal engagement surface2142 of thecentral portion2140 preventing theproximal retention member2160 from sliding further. Similar to implant1100, when theimplant2100 is in the second configuration thedistal retention member2120 and/or theproximal retention member2160 are offset from thecentral portion2140 in a direction substantially normal to the longitudinal axis A_L.
• In use,implant2100 in the first configuration, is inserted percutaneously between a pair of adjacent spinous processes (not shown inFIGS. 14-21). For example, a medical practitioner can insert theimplant2100 percutaneously (e.g., through a cannula, over a guide wire, or the like) into a body of a patient. In some embodiments, an insertion tool such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety, can be used to insert theimplant2100 into a body of a patient. The insertion tool can be configured to be removably coupled to thetool engagement member2182 such that rotation of thetool engagement member2182 relative to the insertion tool about the longitudinal axis A_Lis limited. More particularly, a portion of the insertion tool can be disposed about thehex portion2185 of thetool engagement member2182 such that rotational motion about the longitudinal axis A_Lis limited. Additionally, the insertion tool can include a threaded portion configured to be threadedly coupled within the threadedportion2190 of thehex portion2185. In this manner, the insertion tool can be removably coupled to thetool engagement member2182 such that axial movement of thetool engagement member2182 relative to the insertion tool is limited.
• The insertion tool can include actuator configured to be inserted into thetool head2184 of thedrive screw2183 to rotate thedrive screw2183 about the longitudinal axis A_L. This arrangement allows thedrive screw2183 to be rotated without rotating the other portions of theimplant2100. Accordingly, theimplant2100 can be inserted into, repositioned within and/or removed from a body, as described above.
• Once between the spinous processes, theimplant2100 can be moved from the first configuration to the second configuration. In the second configuration, theproximal retention member2160 and thedistal retention member2120 are offset from thecentral portion2140 and positioned to limit lateral movement of theimplant2100 with respect to the spinous processes. Theproximal retention member2160 and thedistal retention member2120 are configured to engage a spinous process (i.e., either directly or through surrounding tissue) and/or be adjacent to a spinous process when in the second configuration. Said another way, thedistal retention member2120, theproximal retention member2160 and thecentral portion2140 form a saddle, within which a spinous process can be disposed.
• FIGS. 22-23 show animplant3100, according to an embodiment. As shown inFIG. 22, theimplant3100 includes anactuator3111, adistal retention member3120, acentral portion3140, aproximal retention member3160, and atool engagement member3182. The structure and operation of theactuator3111,distal retention member3120,central portion3140, andproximal retention member3160 are similar to the structure and operation of theactuator2111,distal retention member2120,central portion2140, andproximal retention member2160, respectively. Accordingly, only thetool engagement member3182 is described in detail below.
• Tool engagement member3182 includes anengagement surface3186 and acoupling protrusion3185. Theengagement surface3186 includes adovetail protrusion3188, which is similar to the structure and operation of theengagement surface2186 and theprotrusion2188 ofimplant2100, respectively. As such, theengagement surface3186 and thedovetail protrusion3188 are not described in detail.
• Thetool coupling protrusion3185 is configured to be removably coupled to aninsertion tool3195. Details of theinsertion tool3195 are described in more detail in copending U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. Specifically, thetool coupling protrusion3185 is configured receive ashaft3197 of theinsertion tool3195. The end of theshaft3197 is configured to engage atool head3184 of adrive screw3183. In use, theshaft3197 can rotate thedrive screw3183 to move theimplant3100 between a first configuration and a second configuration, as described above.
• Moreover, thetool coupling protrusion3185 includes agroove3190 configured to receive a snap-ring3196 of theinsertion tool3195. The snap-ring3196 can be, for example, spring coil. In this manner, theinsertion tool3195 can retain theimplant3100, when theimplant3100 is inserted into a body of a patient. More particularly, the snap-ring3196 and thegroove3190 can collectively form an interference fit such both axial and rotation movement of theimplant3100 relative to theinsertion tool3195 is limited.
• Thetool coupling protrusion3185 includes a lead-inchamfer3181 to facilitate the docking of theinsertion tool3195 to theimplant3100. Although not shown inFIG. 23, in some embodiments, the lumen defined by thecoupling protrusion3185 can also include a lead-in chamfer, a tapered portion and/or a beveled edge to facilitate the insertion of theshaft3197 theinsertion tool3195 into thecoupling protrusion3185. Said another way, in some embodiments, thecoupling protrusion3185 can include an inner-diameter chamfer.
• FIGS. 24-30 show animplant4100, according to an embodiment.Implant4100 includes adistal end portion4110, acentral portion4140 and aproximal end portion4180. At least a portion of thecentral portion4140 is between thedistal end portion4110 and theproximal end portion4180. Theimplant4100 defines alumen4146 and includes adrive screw4183 disposed within thelumen4146. Thedrive screw4183 has atool head4184 configured to mate with and/or receive a tool for rotating thedrive screw4183, as further described herein.
• Distal end portion4110 ofimplant4100 includes anactuator4111, a firstdistal retention member4120 and a seconddistal retention member4130.Actuator4111 includes a taperedsurface4112, a threaded portion4114 (seeFIG. 28), afirst engagement surface4116, asecond engagement surface4117, afirst protrusion4118, asecond protrusion4119, a first stabilizingpin4113 and a second stabilizing pin4115 (seeFIG. 28). The threadedportion4114 is disposed fixedly within thelumen4146 and is configured to receive thedrive screw4183. In other embodiments, the insertion member can include a captive nut configured to receive the drive screw. The first stabilizingpin4113 and the second stabilizingpin4115 of theactuator4111 are elongated members configured to slidably couple theactuator4111 to thecentral portion4140 to prevent independent rotational movement of theactuator4111 with respect to thecentral portion4140.
• Thefirst engagement surface4116 of theactuator4111 is angularly offset from the longitudinal axis A_Lof theimplant4100 by an angle between 0 degrees and 90 degrees. As described in more detail herein, the angular offset of thefirst engagement surface4116 is associated with moving theimplant4100 between a first configuration (FIG. 24) and a second configuration (FIG. 25).
• Thefirst engagement surface4116 includes afirst protrusion4118 having an undercut. More particularly, thefirst protrusion4118 has a trapezoidal cross-sectional shape. In this embodiment, thefirst protrusion4118 is a dovetail protrusion. Thefirst protrusion4118 is configured to engage agroove4124 of the firstdistal retention member4120. Similarly, thesecond engagement surface4117 includes asecond protrusion4119 having an undercut. More particularly, thesecond protrusion4119 has a trapezoidal cross-sectional shape. In this embodiment, thesecond protrusion4119 is a dovetail protrusion. Thesecond protrusion4119 is configured to engage agroove4134 of the seconddistal retention member4130.
• The firstdistal retention member4120 includes anouter surface4121, afirst engagement surface4122, and asecond engagement surface4123, opposite thefirst engagement surface4122. The firstdistal retention member4120 defines a notch4128 configured to allow thedrive screw4183 to pass therethrough when theimplant4100 is in the first configuration. Said another way, when theimplant4100 is in the first configuration, the notch4128 is aligned with thelumen4146.
• Thefirst engagement surface4122 of the firstdistal retention member4120 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant4100 by an angle between 90 degrees and 180 degrees. Said another way, thefirst engagement surface4122 of the firstdistal retention member4120 defines a plane that is angularly offset from the longitudinal axis A_Lby an obtuse angle. Moreover, thefirst engagement surface4122 of the firstdistal retention member4120 is substantially parallel to thefirst engagement surface4116 of theactuator4111. Said another way, the angular offset of thefirst engagement surface4122 of thedistal retention member4120 is supplementary to the angular offset of thefirst engagement surface4116 of theactuator4111. Accordingly, the firstdistal retention member4120 is slidably disposed againstactuator4111.
• Moreover, thefirst engagement surface4122 of the firstdistal retention member4120 defines agroove4124. Thegroove4124 has a trapezoidal cross-sectional shape. In this embodiment, thegroove4124 has a dovetail shape that corresponds to the shape of thefirst protrusion4118 of theactuator4111. Thegroove4124 is configured to slidingly receive thefirst protrusion4118 of theactuator4111. The undercut of thefirst protrusion4118 of theactuator4111 slidably maintains thefirst protrusion4118 of theactuator4111 within thegroove4124. Thegroove4124 of thefirst engagement surface4122 and theprotrusion4118 of theactuator4111 collectively allow movement of the firstdistal retention member4120, with respect to theactuator4111, in a direction substantially parallel to thefirst engagement surface4122 of the firstdistal retention member4120. Moreover, thegroove4124 of thefirst engagement surface4122 and theprotrusion4118 of theactuator4111 collectively limit movement of the firstdistal retention member4120, with respect to theactuator4111, in a direction substantially normal to thefirst engagement surface4122 of thedistal retention member4120. Thefirst engagement surface4122 of the firstdistal retention member4120 contacts and is configured to slide along thefirst engagement surface4116 of theactuator4111 when thegroove4124 slides along thefirst protrusion4118 of theactuator4111.
• Thesecond engagement surface4123 of the firstdistal retention member4120 is substantially parallel to thedistal engagement surface4143 of thecentral portion4140 and defines a plane substantially normal to the longitudinal axis A_Lof theimplant4100. Thesecond engagement surface4123 of the firstdistal retention member4120 can be slidably disposed against and/or coupled to thecentral portion4140 of theimplant4100.
• The seconddistal retention member4130 includes anouter surface4131, afirst engagement surface4132, and asecond engagement surface4133, opposite thefirst engagement surface4132. The seconddistal retention member4130 defines a notch4138 configured to allow thedrive screw4183 to pass therethrough when theimplant4100 is in the first configuration. Moreover, thefirst engagement surface4132 of the seconddistal retention member4130 defines agroove4134. The structure and function of seconddistal retention member4130 is similar to that of the firstdistal retention member4120, and is therefore not described in detail.
• Proximal end portion4180 ofimplant4100 includes atool engagement member4182, a firstproximal retention member4160 and a secondproximal retention member4170.Tool engagement member4182 is configured to mate with and/or receive an insertion tool, such as those described in copending U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. In some embodiments, for example, an insertion tool (not shown) can be coupled to an outer surface of thetool engagement member4182. In such embodiments, the outer surface of thetool engagement member4182 can be configured to facilitate the docking of the insertion tool (not shown) to theimplant4100. For example, in some embodiments, the outer surface of thetool engagement member4182 can include a lead-in chamfer, a tapered portion and/or a beveled edge to facilitate the docking of the insertion tool onto thetool engagement member4182 of theimplant4100.
• Tool engagement member4182 includes afirst engagement surface4186, asecond engagement surface4187, a first stabilizingpin4181 and a second stabilizing pin4185 (seeFIG. 28). The first stabilizingpin4181 and the second stabilizingpin4185 of thetool engagement member4182 are elongated members configured to slidably couple thetool engagement member4182 to thecentral portion4140 to prevent independent rotational movement of thetool engagement member4182 with respect to thecentral portion4140.
• Thefirst engagement surface4186 of thetool engagement member4182 is angularly offset from the longitudinal axis A_Lof theimplant4100 by an angle between 0 degrees and 90 degrees. As described in more detail herein, the angular offset of thefirst engagement surface4186 is associated with moving theimplant4100 between a first configuration (FIG. 24) and a second configuration (FIG. 25).
• Thefirst engagement surface4186 includes afirst protrusion4188 having an undercut. More particularly, thefirst protrusion4188 has a trapezoidal cross-sectional shape. In this embodiment, thefirst protrusion4188 is a dovetail protrusion. Thefirst protrusion4188 is configured to engage agroove4164 of the firstproximal retention member4160. Similarly, thesecond engagement surface4187 of thetool engagement member4182 includes asecond protrusion4189 having an undercut. More particularly, thesecond protrusion4189 has a trapezoidal cross-sectional shape. In this embodiment, thesecond protrusion4189 is a dovetail protrusion. Thesecond protrusion4189 is configured to engage agroove4174 of the secondproximal retention member4170.
• The firstproximal retention member4160 includes anouter surface4161, afirst engagement surface4162, and asecond engagement surface4163, opposite thefirst engagement surface4162. The firstproximal retention member4160 defines a notch4168 configured to allow thedrive screw4183 to pass therethrough when theimplant4100 is in the first configuration. Said another way, when theimplant4100 is in the first configuration, the notch4168 is aligned with thelumen4146.
• Thefirst engagement surface4162 of the firstproximal retention member4160 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant4100 by an angle between 90 degrees and 180 degrees. Moreover, thefirst engagement surface4162 of the firstproximal retention member4120 is substantially parallel to thefirst engagement surface4186 of thetool engagement member4182. Said another way, the angular offset of thefirst engagement surface4162 of the firstproximal retention member4160 is supplementary with the angular offset of thefirst engagement surface4186 of thetool engagement member4182. Accordingly, the firstproximal retention member4160 is slidably disposed against thetool engagement member4182.
• Thefirst engagement surface4162 of the firstproximal retention member4160 defines agroove4164. Thegroove4164 has a trapezoidal cross-sectional shape. In this embodiment, thegroove4164 has a dovetail shape that corresponds to the shape of thefirst protrusion4188 of thetool engagement member4182. Thegroove4164 is configured to slidingly receive thefirst protrusion4188 of thetool engagement member4182. The undercut of thefirst protrusion4188 of thetool engagement member4182 slidably maintains thefirst protrusion4188 of thetool engagement member4182 within thefirst groove1124. Thegroove4164 of thefirst engagement surface4162 and thefirst protrusion4188 of thetool engagement member4182 collectively allow movement of the firstproximal retention member4160, with respect to thetool engagement member4182, in a direction substantially parallel to thesecond engagement surface4163 of first theproximal retention member4160. Moreover, thegroove4164 of thefirst engagement surface4162 and thefirst protrusion4188 of thetool engagement member4182 collectively limit movement of the firstproximal retention member4160, with respect to thetool engagement member4182, in a direction substantially normal to thefirst engagement surface4162 of the firstproximal retention member4160. Thefirst engagement surface4162 of the firstproximal retention member4160 contacts and is configured to slide along thefirst engagement surface4186 of thetool engagement member4182 when thegroove4164 slides along thefirst protrusion4188 of thetool engagement member4182.
• Thesecond engagement surface4163 of the firstproximal retention member4160 is substantially parallel to theproximal engagement surface4142 of thecentral portion4140 and defines a plane substantially normal to the longitudinal axis A_Lof theimplant4100. In other embodiments, the plane defined by thesecond engagement surface4163 of the firstproximal retention member4160 can be angularly offset from the longitudinal axis A_Lof theimplant4100 by an angle other than 90 degrees. Thesecond engagement surface4163 of the firstproximal retention member4160 can be slidably disposed against and/or coupled to thecentral portion4140 of theimplant4100.
• The secondproximal retention member4170 includes anouter surface4171, afirst engagement surface4172, and asecond engagement surface4173, opposite thefirst engagement surface4172. The secondproximal retention member4170 defines a notch4178 configured to allow thedrive screw4183 to pass through the secondproximal retention member4170 when theimplant4100 is in the first configuration. Moreover, thefirst engagement surface4172 of the secondproximal retention member4170 defines agroove4174. The secondproximal retention member4170 is configured similar to the firstproximal retention member4160, and is therefore not discussed in detail below.
• Thecentral portion4140 ofimplant4100 includes anouter surface4141, aproximal engagement surface4142 and adistal engagement surface4143. Thecentral portion4140 also defines a firstproximal stabilizing groove4144, a second proximal stabilizing groove (not shown inFIG. 28), a first distal stabilizing groove (not shown inFIG. 28) and a second distal stabilizing groove1149 (seeFIG. 28).
• Thesecond engagement surface4163 of the firstproximal retention member4160 and thesecond engagement surface4173 of the secondproximal retention member4170 are both configured to slide along theproximal engagement surface4142 of thecentral portion4140. Likewise, thesecond engagement surface4123 of the firstdistal retention member4120 and thesecond engagement surface4133 of the seconddistal retention member4130 are both configured to slide along thedistal engagement surface4143 of thecentral portion4140.
• FIG. 28 is a cross-sectional view of the implant illustrated inFIG. 24, taken along line X-X inFIG. 24. The first distal stabilizing groove (not shown inFIG. 28) and the second distal stabilizinggroove4149 of thecentral portion4140 are configured to receive thefirst stabilization pin4113 and thesecond stabilization pin4115 of theactuator4111 respectively. Likewise, the firstproximal stabilizing groove4144 and the second proximal stabilizing groove (not shown inFIG. 28) of thecentral portion4140 are configured to receive thefirst stabilization pin4181 and thesecond stabilization pin4185 of thetool engagement member4182 respectively. This configuration prevents theproximal end portion4180 and thedistal end portion4110 from rotating with respect to thecentral portion4140.
• Implant4100 has a first configuration and a second configuration.FIG. 24 shows theimplant4100 in a first configuration. When theimplant4100 is in the first configuration, theproximal end portion4180, thedistal end portion4110 and thecentral portion4140 are substantially coaxial (i.e., substantially share a common longitudinal axis). Said another way, when theimplant4100 is in the first configuration, theouter surface4121 of the firstdistal retention member4120 and theouter surface4161 of the firstproximal retention member4160 are substantially aligned with theouter surface4141 of thecentral portion4140. Said another way, theouter surface4121 of the firstdistal retention member4120, theouter surface4161 of the firstproximal retention member4160, and theouter surface4141 of thecentral portion4140 form a substantially continuous surface. Similarly, theouter surface4131 of the seconddistal retention member4130 and theouter surface4171 of the secondproximal retention member4170 are similarly aligned with theouter surface4141 of thecentral portion4140 when theimplant4100 is in the first configuration.
• Theimplant4100 can be moved between the first configuration and the second configuration as illustrated inFIG. 25. To move theimplant4100 from the first configuration to the second configuration, thedrive screw4183 is rotated. When thedrive screw4183 is rotated as indicated by the arrow CC inFIG. 24, thedrive screw4183 pulls theactuator4111 and thetool engagement member4182 toward thecentral portion4140. Thefirst engagement surface4116 of theactuator4111 exerts an axial force on thefirst engagement surface4122 of the firstdistal retention member4120 and thesecond engagement surface4117 of theactuator4111 exerts an axial force on thefirst engagement surface4132 of the seconddistal retention member4130. Because thefirst engagement surface4116 of theactuator4111 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via thefirst engagement surface4116 of theactuator4111 to thefirst engagement surface4122 of the firstdistal retention member4120 has a direction as shown by the arrow AA inFIG. 25. Similarly, because thesecond engagement surface4117 of theactuator4111 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via thesecond engagement surface4117 of theactuator4111 to thefirst engagement surface4132 of the seconddistal retention member4130 has a direction as shown by the arrow BB inFIG. 25. Said another way, a component of the forces exerted by theactuator4111 on the firstdistal retention member4120 and the seconddistal retention member4130 has a direction that is substantially normal to the longitudinal axis A_L. These forces cause the firstdistal retention member4120 to slide on thefirst engagement surface4116 of theactuator4111 causing the firstdistal retention member4120 to move in the direction AA and the seconddistal retention member4130 to slide on thesecond engagement surface4117 of theactuator4111 causing the seconddistal retention member4130 to move in the direction BB.
• Similarly, when thedrive screw4183 is rotated as indicated by the arrow CC inFIG. 24, thefirst engagement surface4186 of thetool engagement member4182 exerts an axial force on thefirst engagement surface4182 of the firstproximal retention member4160 and thesecond engagement surface4187 of thetool engagement member4182 exerts an axial force on thefirst engagement surface4172 of the secondproximal retention member4170. Because thefirst engagement surface4186 of thetool engagement member4182 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via thefirst engagement surface4186 of thetool engagement member4182 to thefirst engagement surface4162 of the firstproximal retention member4160 has a direction as shown by the arrow AA inFIG. 25. Similarly, because thesecond engagement surface4187 of thetool engagement member4182 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via thesecond engagement surface4187 of thetool engagement member4182 to thefirst engagement surface4172 of the secondproximal retention member4170 has a direction as shown by the arrow BB inFIG. 25. Said another way, a component of the forces exerted by thetool engagement member4182 on the firstproximal retention member4160 and the secondproximal retention member4170 has a direction that is substantially normal to the longitudinal axis A_L. These forces cause the firstproximal retention member4160 to slide on thefirst engagement surface4186 of thetool engagement member4182 causing the firstproximal retention member4160 to move in the direction AA and the secondproximal retention member4170 to slide on thesecond engagement surface4187 of thetool engagement member4182 causing the secondproximal retention member4170 to move in the direction BB. The dovetail configuration of thegrooves4124,4134,4164,4174 of theretention members4120,4130,4160,4170 prevents theretention members4120,4130,4160,4170 from sliding past the second configuration.
• When theimplant4100 is in the second configuration the firstdistal retention member4120, the seconddistal retention member4130, the firstproximal retention member4160 and/or the secondproximal retention member4170 are offset from thecentral portion4140 in a direction substantially normal to the longitudinal axis A_L. Said another way, theouter surface4121 of the firstdistal retention member4120 and/or theouter surface4161 of the firstproximal retention member4160 are not aligned with theouter surface4141 of thecentral portion4140 and are discontinuous with theouter surface4141 of thecentral portion4140. Similarly, theouter surface4131 of the seconddistal retention member4130 and theouter surface4171 of the secondproximal retention member4170 are similarly situated with respect to theouter surface4141 of thecentral portion4140 when theimplant4100 is in the second configuration.
• As described above, when theimplant4100 is positioned between the spinous processes, theimplant4100 can be moved from the first configuration to the second configuration. In the second configuration, the firstdistal retention member4120 and the firstproximal retention member4160 are offset from thecentral portion4140 to limit lateral movement of theimplant4100 with respect to the spinous processes. Said another way, the firstdistal retention member4120, the firstproximal retention member4160 and thecentral portion4140 form a saddle, within which a first spinous process can be disposed. Similarly, in the second configuration, the seconddistal retention member4130 and the secondproximal retention member4170 are offset from thecentral portion4140 to limit lateral movement of theimplant4100 with respect to the spinous processes. Said another way, the seconddistal retention member4130, the secondproximal retention member4170 and thecentral portion4140 form a saddle, within which a second spinous process can be disposed.
• FIGS. 31-44 show animplant5100, according to an embodiment.Implant5100 includes adistal end portion5110, acentral portion5140 and aproximal end portion5180. Thecentral portion5140 is coupled between thedistal end portion5110 and theproximal end portion5180. Theimplant5100 defines alumen5146 and includes adrive screw5183 disposed within the lumen5146 (seeFIG. 37). Thedrive screw5183 has atool head5184 configured to mate with and/or receive a tool for rotating thedrive screw5183, as further described herein.
• Distal end portion5110 ofimplant5100 includes anactuator5111, a firstdistal retention member5120 and a seconddistal retention member5130.Actuator5111 includes a taperedsurface5112, a threaded portion5114 (seeFIG. 37), afirst engagement surface5116, asecond engagement surface5117, afirst protrusion5118 and asecond protrusion5119. The threadedportion5114 is disposed fixedly within thelumen5146 and is configured to receive thedrive screw5183. In other embodiments, theactuator5111 can include a captive nut configured to receive thedrive screw5183.
• Thefirst engagement surface5116 of theactuator5111 is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 0 degrees and 90 degrees. Thefirst engagement surface5116 includes afirst protrusion5118 having a trapezoidal cross-sectional shape. In this embodiment, thefirst protrusion5118 is a dovetail protrusion. As described in more detail below, the firstdistal retention member5120 is maintained in sliding contact with theactuator5111 via thefirst protrusion5118.
• Thesecond engagement surface5117 of theactuator5111 is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 0 degrees and 90 degrees. Thesecond engagement surface5117 includes asecond protrusion5119 having a trapezoidal cross-sectional shape. In this embodiment, thesecond protrusion5119 is a dovetail protrusion. As described in more detail below, the seconddistal retention member5130 is maintained in sliding contact with theactuator5111 via thesecond protrusion5119.
• The firstdistal retention member5120 includes anouter surface5121, afirst engagement surface5122, asecond engagement surface5123 opposite thefirst engagement surface5122, and aprotrusion5126. The firstdistal retention member5120 defines a notch5128 (seeFIG. 42) configured to allow thedrive screw5183 to pass through the firstdistal retention member5120 when theimplant5100 is in the first configuration. Said another way, when theimplant5100 is in the first configuration, thenotch5128 is aligned with thelumen5146.
• Theprotrusion5126 has a trapezoidal cross-sectional shape and is configured to be received within a groove of thefirst support member5141. In this embodiment, thesecond protrusion5126 is a dovetail protrusion. In this manner, the firstdistal retention member5120 is maintained in sliding contact with thefirst support member5141 via theprotrusion5126. Additionally, theprotrusion5126 of the firstdistal retention member5120 is configured to engage a portion of the first support member5141 (see e.g.,FIG. 33) to limit movement of the firstdistal retention member5120 relative to thefirst support member5141 and/or move thefirst support member5141 in a direction normal to the longitudinal axis A_L.
• Thefirst engagement surface5122 of the firstdistal retention member5120 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 90 degrees and 180 degrees. Moreover, thefirst engagement surface5122 of the firstdistal retention member5120 is substantially parallel to thefirst engagement surface5116 of theactuator5111. Accordingly, the firstdistal retention member5120 is slidably disposed against theactuator5111.
• Thefirst engagement surface5122 of the firstdistal retention member5120 defines agroove5124. Thegroove5124 has a trapezoidal cross-sectional shape. In this embodiment, thegroove5124 has a dovetail shape that corresponds to the shape of thefirst protrusion5118 of theactuator5111. Thegroove5124 is configured to slidingly receive thefirst protrusion5118 of theactuator5111. The undercut of thefirst protrusion5118 of theactuator5111 slidably maintains thefirst protrusion5118 of theactuator5111 within thegroove5124. Thegroove5124 of thefirst engagement surface5122 and thefirst protrusion5118 of theactuator5111 collectively allow movement of the firstdistal retention member5120, with respect to theactuator5111, in a direction substantially parallel to thefirst engagement surface5122 of the firstdistal retention member5120. Moreover, thegroove5124 of thefirst engagement surface5122 and thefirst protrusion5118 of theactuator5111 collectively limit movement of the firstdistal retention member5120, with respect to theactuator5111, in a direction substantially normal to thefirst engagement surface5122 of the firstdistal retention member5120. Thefirst engagement surface5122 of the firstdistal retention member5120 contacts and is configured to slide along thefirst engagement surface5116 of theactuator5111 when thegroove5124 slides along thefirst protrusion5118 of theactuator5111.
• Thesecond engagement surface5123 of the firstdistal retention member5120 is substantially parallel to thedistal engagement surface5143 of thefirst support member5141 of thecentral portion5140, and defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 0 degrees and 90 degrees. Moreover, the angular offset of thesecond engagement surface5123 of the firstdistal retention member5120 is different than the angular offset of thefirst engagement surface5122 of the firstdistal retention member5120. Accordingly, the firstdistal retention member5120 is slidably disposed against thefirst support member5141 of thecentral portion5140.
• The seconddistal retention member5130 includes anouter surface5131, afirst engagement surface5132, asecond engagement surface5133 opposite thefirst engagement surface5132, and aprotrusion5136. The seconddistal retention member5130 defines a notch5138 configured to allow thedrive screw5183 to pass the seconddistal retention member5130 when theimplant5100 is in the first configuration. Moreover, thefirst engagement surface5132 of the seconddistal retention member5130 defines agroove5134. The seconddistal retention member5130 is configured similar to the firstdistal retention member5120, and is therefore not described in detail.
• Theproximal end portion5180 ofimplant5100 includes atool engagement member5182, a firstproximal retention member5160 and a secondproximal retention member5170.Tool engagement member5182 is configured to mate with and/or receive an insertion tool, such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. In some embodiments, for example, an insertion tool can be coupled to an outer surface of thetool engagement member5182. In such embodiments, the outer surface of thetool engagement member5182 can be configured to facilitate the docking of the insertion tool (not shown) to theimplant5100. For example, in some embodiments, the outer surface of thetool engagement member5182 can include a lead-in chamfer, a tapered portion and/or a beveled edge to facilitate the docking of the insertion tool onto thetool engagement member5182 of theimplant5100.Tool engagement member5182 includes afirst engagement surface5186, asecond engagement surface5187, afirst protrusion5188, asecond protrusion5189 and acap5185. Thecap5185 is configured to hold thedrive screw5183 in place, preventing axial movement of thedrive screw5183.
• Thefirst engagement surface5186 of thetool engagement member5182 is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 0 degrees and 90 degrees. Said another way, thefirst engagement surface5186 of thetool engagement member5182 is angularly offset from the longitudinal axis A_Lof theimplant5100 by an acute angle. As described in more detail herein, the angular offset of thefirst engagement surface5186 is associated with moving theimplant5100 between a first configuration (FIG. 31) and a second configuration (FIG. 32).
• Thefirst protrusion5188 of thetool engagement member5182 has an undercut such that the firstproximal retention member5160 can be slidably coupled to thetool engagement member5182. Thefirst protrusion5188 has a trapezoidal cross-sectional shape. In this embodiment, thefirst protrusion5188 is a dovetail protrusion.
• Thesecond engagement surface5187 of thetool engagement member5182 is similar to thefirst engagement surface5186 of thetool engagement member5182. Thesecond protrusion5189 of thetool engagement member5182 has an undercut such that the secondproximal retention member5170 can be slidably coupled to thetool engagement member5182. Thesecond protrusion5189 has a trapezoidal cross-sectional shape. In this embodiment, thesecond protrusion5189 is a dovetail protrusion.
• The firstproximal retention member5160 includes anouter surface4161, afirst engagement surface5162, asecond engagement surface5163 opposite thefirst engagement surface5162, and aprotrusion5166. Theprotrusion5166 of the firstproximal retention member5160 has an undercut such that thefirst support member5141 of thecentral portion5140 can be slidably coupled to the firstproximal retention member5160. Theprotrusion5166 has a trapezoidal cross-sectional shape. In this embodiment, theprotrusion5166 is a dovetail protrusion. The firstproximal retention member5160 defines a notch5168 configured to allow thedrive screw5183 to pass through the firstproximal retention member5160 when theimplant5100 is in the first configuration. Said another way, when theimplant5100 is in the first configuration, the notch5168 is aligned with thelumen5146.
• Thefirst engagement surface5162 of the firstproximal retention member5160 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 90 degrees and 180 degrees. Said another way, thefirst engagement surface5162 of the firstproximal retention member5160 defines a plane that is angularly offset from the longitudinal axis A_Lby an obtuse angle. Moreover, thefirst engagement surface5162 of the firstproximal retention member5120 is substantially parallel to thefirst engagement surface5186 of thetool engagement member5182. Said another way, the angular offset of thefirst engagement surface5162 of the firstproximal retention member5160 is supplementary with the angular offset of thefirst engagement surface5186 of thetool engagement member5182. Accordingly, the firstproximal retention member5160 is slidably disposed against thetool engagement member5182.
• Moreover, thefirst engagement surface5162 of the firstproximal retention member5160 defines agroove5164. Thegroove5164 has a trapezoidal cross-sectional shape. In this embodiment, thegroove5164 has a dovetail shape that corresponds to the shape of thefirst protrusion5188 of thetool engagement member5182. Thegroove5164 is configured to slidingly receive thefirst protrusion5188 of thetool engagement member5182. The undercut of thefirst protrusion5188 of thetool engagement member5182 slidably maintains thefirst protrusion5188 of thetool engagement member5182 within thegroove5164. Thegroove5164 of thefirst engagement surface5162 and thefirst protrusion5188 of thetool engagement member5182 collectively allow movement of the firstproximal retention member5160, with respect to thecentral portion5140, in a direction substantially parallel to thesecond engagement surface5163 of the firstproximal retention member5160. Moreover, thegroove5164 of thefirst engagement surface5162 and thefirst protrusion5188 of thetool engagement member5182 collectively limit movement of the firstproximal retention member5160, with respect to thecentral portion5140, in a direction substantially normal to thesecond engagement surface5163 of the firstproximal retention member5160. Thefirst engagement surface5162 of the firstproximal retention member5160 contacts and is configured to slide along thefirst engagement surface5186 of thetool engagement member5182 when thegroove5164 slides along thefirst protrusion5188 of thetool engagement member5182.
• Thesecond engagement surface5163 of the firstproximal retention member5160 is substantially parallel to theproximal engagement surface5142 of thefirst support member5141 of thecentral portion5140, and defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 0 degrees and 90 degrees. Moreover, the angular offset of thesecond engagement surface5163 of the firstproximal retention member5160 is supplementary with the angular offset of theproximal engagement surface5142 of thefirst support member5141 of thecentral portion5140. Accordingly, the firstproximal retention member5160 is slidably disposed against thefirst support member5141 of thecentral portion5140. In other embodiments, the plane defined by thesecond engagement surface5163 of the firstproximal retention member5160 can be normal to the longitudinal axis A_Lof theimplant5100.
• The secondproximal retention member5170 includes anouter surface4171, afirst engagement surface5172, asecond engagement surface5173 opposite thefirst engagement surface5172, and aprotrusion5176. Theprotrusion5176 of the secondproximal retention member5170 has an undercut such that thesecond support member5151 of thecentral portion5140 can be slidably coupled to the secondproximal retention member5170. Theprotrusion5176 has a trapezoidal cross-sectional shape. In this embodiment, theprotrusion5176 is a dovetail protrusion. Additionally, the secondproximal retention member5170 defines a notch5178 configured to allow thedrive screw5183 to pass through the secondproximal retention member5170 when theimplant5100 is in the first configuration. Moreover, thefirst engagement surface5172 of the secondproximal retention member5170 defines agroove5174. The secondproximal retention member5170 is configured similar to the firstproximal retention member5160.
• Thecentral portion5140 ofimplant5100 includes afirst support member5141 and asecond support member5151. Thefirst support member5141 includes anouter surface5149, aproximal engagement surface5142, and adistal engagement surface5143. Thefirst support member5141 defines a notch5148 (seeFIG. 41) configured to allow thedrive screw5183 to pass through thefirst support member5141 when theimplant5100 is in the first configuration. Said another way, when theimplant5100 is in the first configuration, thenotch5148 is aligned with thelumen5146.
• Thedistal engagement surface5143 of thefirst support member5141 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 90 degrees and 180 degrees. Moreover, the angular offset of thedistal engagement surface5143 of thefirst support member5141 is supplementary with the angular offset of thesecond engagement surface5123 of the firstdistal retention member5120. Accordingly, thefirst support member5141 is slidably disposed against the firstdistal retention member5120.
• Moreover, thedistal engagement surface5143 of thefirst support member5141 defines adistal groove5145. Thedistal groove5145 is configured to slidingly receive theprotrusion5126 of the firstdistal retention member5120. The undercut of theprotrusion5126 of the firstdistal retention member5120 slidably maintains theprotrusion5126 of the firstdistal retention member5120 within thedistal groove5145. Thedistal engagement surface5143 of thefirst support member5141 contacts and is configured to slide along thesecond engagement surface5123 of the firstdistal retention member5120 when thedistal groove5145 slides along theprotrusion5126 of the firstdistal retention member5120.
• Theproximal engagement surface5142 of thefirst support member5141 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant5100 by an angle between 90 degrees and 180 degrees. Moreover, the angular offset of theproximal engagement surface5142 of thefirst support member5141 is supplementary with the angular offset of thesecond engagement surface5163 of the firstproximal retention member5160. Accordingly, thefirst support member5141 is slidably disposed against the firstproximal retention member5160.
• Moreover, theproximal engagement surface5142 of thefirst support member5141 defines aproximal groove5144. Theproximal groove5144 is configured to slidingly receive theprotrusion5166 of the firstproximal retention member5160. The undercut of theprotrusion5166 of the firstproximal retention member5160 slidably maintains theprotrusion5166 of the firstproximal retention member5160 within theproximal groove5144. Theproximal engagement surface5142 of thefirst support member5141 contacts and is configured to slide along thesecond engagement surface5163 of the firstproximal retention member5160 when theproximal groove5144 slides along theprotrusion5166 of the firstproximal retention member5160.
• Likewise, thesecond support member5151 of thecentral portion5140 includes anouter surface5159, aproximal engagement surface5152, and adistal engagement surface5153. Thesecond support member5151 defines a notch5156 configured to allow thedrive screw5183 to pass through thesecond support member5151 when theimplant5100 is in the first configuration. Theproximal engagement surface5152 defines aproximal groove5154 and thedistal engagement surface5153 defines adistal groove5155. Thesecond support member5151 is configured similar to thefirst support member5141.
• Implant5100 has a first configuration and a second configuration.FIG. 31 shows theimplant5100 in a first configuration. When theimplant5100 is in the first configuration, theproximal end portion5180, thedistal end portion5110 and thecentral portion5140 are substantially coaxial (i.e., substantially share a common longitudinal axis). Said another way, when theimplant5100 is in the first configuration, theouter surface5121 of the firstdistal retention member5120 and theouter surface5161 of the firstproximal retention member5160 are substantially aligned with theouter surface5149 of thefirst support member5141 of thecentral portion5140. Said another way, theouter surface5121 of the firstdistal retention member5120, theouter surface5161 of the firstproximal retention member5160, and theouter surface5149 of thefirst support member5141 of thecentral portion5140 form a substantially continuous surface. Said yet another way, theouter surface5121 of the firstdistal retention member5120 and theouter surface5161 of the firstproximal retention member5160 are flush with theouter surface5149 of thefirst support member5141 of thecentral portion5140. Similarly, theouter surface5131 of the seconddistal retention member5130 and theouter surface5171 of the secondproximal retention member5170 are similarly aligned with theouter surface5159 of thesecond support member5151 of thecentral portion5140 when theimplant5100 is in the first configuration.
• Theimplant5100 can be moved between the first configuration and the second configuration as illustrated inFIG. 32. To move theimplant5100 from the first configuration to the second configuration, thedrive screw5183 is rotated. When thedrive screw5183 is rotated as indicated by the arrow CC inFIG. 31, thedrive screw5183 pulls theactuator5111 and thetool engagement member5182 toward thecentral portion5140. Thefirst engagement surface5116 of theactuator5111 exerts an axial force on thefirst engagement surface5122 of the firstdistal retention member5120 and thesecond engagement surface5117 of theactuator5111 exerts an axial force on thefirst engagement surface5132 of the seconddistal retention member5130. Because thefirst engagement surface5116 of theactuator5111 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via thefirst engagement surface5116 of theactuator5111 to thefirst engagement surface5122 of the firstdistal retention member5120 has a direction as shown by the arrow AA inFIG. 31. Similarly, because thesecond engagement surface5117 of theactuator5111 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via thesecond engagement surface5117 of theactuator5111 to thefirst engagement surface5132 of the seconddistal retention member5130 has a direction as shown by the arrow BB inFIG. 31. Said another way, a component of the forces exerted by theactuator5111 on the firstdistal retention member5120 and the seconddistal retention member5130 has a direction that is substantially normal to the longitudinal axis A_L. These forces cause the firstdistal retention member5120 to slide on thefirst engagement surface5116 of theactuator5111 causing the firstdistal retention member5120 to move in the direction AA and the seconddistal retention member5130 to slide on thesecond engagement surface5117 of theactuator5111 causing the seconddistal retention member5130 to move in the direction BB.
• Similarly, when thedrive screw5183 is rotated as indicated by the arrow CC inFIG. 31, thefirst engagement surface5186 of thetool engagement member5182 exerts an axial force on thefirst engagement surface5182 of the firstproximal retention member5160 and thesecond engagement surface5187 of thetool engagement member5182 exerts an axial force on thefirst engagement surface5172 of the secondproximal retention member5170. Because thefirst engagement surface5186 of thetool engagement member5182 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via thefirst engagement surface5186 of thetool engagement member5182 to thefirst engagement surface5162 of the firstproximal retention member5160 has a direction as shown by the arrow AA inFIG. 31. Similarly, because thesecond engagement surface5187 of thetool engagement member5182 is at an acute angle with respect to the longitudinal axis A_L, a component of the axial force transmitted via thesecond engagement surface5187 of thetool engagement member5182 to thefirst engagement surface5172 of the secondproximal retention member5170 has a direction as shown by the arrow BB inFIG. 31. Said another way, a component of the forces exerted by thetool engagement member5182 on the firstproximal retention member5160 and the secondproximal retention member5170 has a direction that is substantially normal to the longitudinal axis A_L. These forces cause the firstproximal retention member5160 to slide on thefirst engagement surface5186 of thetool engagement member5182 causing the firstproximal retention member5160 to move in the direction AA and the secondproximal retention member5170 to slide on thesecond engagement surface5187 of thetool engagement member5182 causing the secondproximal retention member5170 to move in the direction BB.
• As the firstproximal retention member5160 and the firstdistal retention member5120 move in direction AA, theprotrusions5166,5126 of the firstproximal retention member5160 and the firstdistal retention member5120, respectively, contact the upper surface of theproximal groove5144 and thedistal groove5145 of thefirst support member5141 respectively, causing thefirst support member5141 to move in the direction AA. In the second configuration, as seen inFIG. 33, thefirst support member5141 is displaced from its position in the first configuration in the direction AA. Likewise, as the secondproximal retention member5170 and the seconddistal retention member5130 move in direction BB, theprotrusions5176,5136 of the secondproximal retention member5170 and the seconddistal retention member5130, respectively, contact the upper surface of theproximal groove5154 and thedistal groove5155 of thesecond support member5151 respectively, causing thesecond support member5151 to move in the direction BB. In the second configuration, as seen inFIG. 33, thesecond support member5151 is displaced from its position in the first configuration in the direction BB. In this manner, thefirst support member5141 and thesecond support member5151 can distract the adjacent spinous processes.
• When theimplant5100 is in the second configuration the firstdistal retention member5120, the seconddistal retention member5130, the firstproximal retention member5160 and/or the secondproximal retention member5170 are offset from thecentral portion5140. Said another way, theouter surface5121 of the firstdistal retention member5120 and/or theouter surface5161 of the firstproximal retention member4160 are not aligned with theouter surface5149 of thefirst support member5141 of thecentral portion5140 and are discontinuous with theouter surface5149 of thefirst support member5141 of thecentral portion5140. Similarly, theouter surface5131 of the seconddistal retention member5130 and theouter surface5171 of the secondproximal retention member5170 are similarly situated with respect to theouter surface5159 of thesecond support member5151 of thecentral portion5140 when theimplant5100 is in the second configuration. Moreover, when the implant is in the second configuration, thefirst support member5141 of thecentral portion5140 and thesecond support member5151 of thecentral portion5140 are offset from the longitudinal axis A_Lin a direction substantially normal to the longitudinal axis A_L.
• In use,implant5100 is inserted percutaneously between a pair of adjacent spinous processes (not shown inFIGS. 31-44), in the first configuration. For example, a medical practitioner can insert theimplant5100 percutaneously (e.g., through a cannula, over a guide wire, or the like) into a body of a patient. An insertion tool, such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety, can be used to insert theimplant5100 into a body of a patient. The insertion tool is configured to be removably coupled to thetool engagement member5182. In this manner, the insertion tool retains theimplant5100. Said another way, the insertion tool limits the rotational movement of theimplant5100, with respect to the insertion tool, about the longitudinal axis A_Land limits the axial movement of theimplant5100, with respect to the insertion tool, about the longitudinal axis A_L. The insertion tool has an actuator configured to be inserted into thetool head5184 of thedrive screw5183. The actuator of the insertion tool is configured to rotate thedrive screw5183 about the longitudinal axis A_L, without rotating the other components of theimplant5100. Said another way, the insertion tool limits rotational movement of thetool engagement member5182 while rotating thedrive screw5183 about the longitudinal axis A_L.
• When inserting theimplant5100 into a body of a patient, thedistal end portion5110 is inserted first and is moved past the spinous processes until thecentral portion5140 is positioned between the spinous processes. In this manner, thecentral portion5140 of theimplant5100 can distract and/or maintain a minimal spacing between the adjacent spinous processes. The distance between the top surface and the bottom surface of thecentral portion5140 can be slightly smaller than the space between the spinous processes to account for surrounding ligaments and tissue. Similar to implant100, in some embodiments, thecentral portion5140 in its first configuration directly contacts the spinous processes between which it is positioned.
• Once between the spinous processes, theimplant5100 can be moved from the first configuration to the second configuration. In the second configuration, the first and secondproximal retention members5160,5170 and the first and seconddistal retention members5120,5130 are offset from theactuator5111 and thetool engagement member5182, and positioned to limit lateral movement of theimplant5100 with respect to the spinous processes. Said another way, the firstdistal retention member5120, the firstproximal retention member5160 and thecentral portion5140 form a saddle, within which a first spinous process can be disposed. Similarly, the seconddistal retention member5130, the secondproximal retention member5170 and thecentral portion5140 form a saddle, within which a second spinous process can be disposed. The first and secondproximal retention members5160,5170 and the first and seconddistal retention members5120,5130 can also further distract the spinous processes. Theproximal retention member5160 and thedistal retention member5120 are configured to engage the superior spinous processes (i.e., either directly or through surrounding tissue) and the secondproximal retention member5170 and the seconddistal retention member5130 are configured to engage the inferior spinous process (i.e., either directly or through surrounding tissue) in the second configuration. Additionally, in the second configuration, thefirst support member5141 of thecentral portion5140 and thesecond support member5151 of the central portion are offset from theactuator5111 and thetool engagement member5182 and positioned to distract the spinous processes. Once in the second configuration, theimplant5100 can be released from the insertion tool and the insertion tool can be removed from the patient's body.
• To remove from and/or reposition theimplant5100 within the body, thedrive screw5183 is rotated as indicated by the arrow DD inFIG. 31, by for example, a removal tool (may be similar to an insertion tool). Rotating the drive screw in direction DD, causes the dovetail configuration of theprotrusions5118,5119 of theinsertion member1111 and the dovetail configurations of theprotrusions5188,5189 of thetool engagement member5182 to pull thedistal retention members5120,5130 and theproximal retention members5160,5170 back into the first configuration. This causes the dovetail configurations of theprotrusions5126,5136 of thedistal retention members5120,5130 and the dovetail configurations of theprotrusions5166,5176 of theproximal retention members5160,5170 to pull thesupport members5141,5151 back into the first configuration. After theimplant5100 is in the first configuration, a medical practitioner can remove from and/or reposition theimplant5100 within the body.
• Although theimplant5100 is shown is being movable between a first configuration (FIG. 31) and a second configuration (FIG. 32), theimplant5100 can be maintained in any number of different configurations. For example, theimplant5100 can be maintained in any suitable configuration between the first configuration and the second configuration. Said another way, theimplant5100 can be placed in an infinite number of different configurations between the first configuration and the second configuration. Thus, the spinous processes can be distracted by thefirst support member5141 and thesecond support member5151 by any desired amount within a predetermined range. In this manner, asingle implant5100 can be used to treat a wide range of conditions and/or locations within the body requiring different amounts of distraction. Moreover, this arrangement allows the amount of distraction to be varied in situ over time.
• For example, in some embodiments, the amount of distraction can be varied within a range of approximately 10 mm to 16 mm. Within this range, the size of thecentral portion5140 can be adjusted to any desired amount by rotating the drive screw5183 a predetermined amount, as described above. In other embodiments, the range of distraction can be approximately 3 mm (e.g., a range from 10 mm to 13 mm, a range from 12 mm to 15 mm, or the like). In yet other embodiments, the range of distraction can be approximately 2 mm (e.g., a range from 10 mm to 12 mm, a range from 12 mm to 14 mm, or the like).
• Although the implants shown and described above are configured to be disposed within a space between adjacent spinous processes, in other embodiments an implant can be configured to be disposed within a spinal disc space, for example, to stabilize and/or distract a spinal segment after disc material is removed from the disc space. In some embodiments, for example, an apparatus includes a spacer and an actuator. The spacer has a first spacer member configured to engage an endplate of a first vertebra and a second spacer member configured to engage an endplate of a second vertebra. The second vertebra can be adjacent the first vertebra. The actuator has a first actuator member and a second actuator member coupled to the first actuator member. The first actuator member is matingly and movably coupled to the first spacer member. Similarly, the first actuator is matingly and movably coupled to the second spacer member. The second actuator member is matingly and movably coupled to the first spacer member. Similarly, the second actuator member is matingly and movably coupled to the second spacer member. The actuator is configured to move the spacer between a first configuration and a second configuration. The first spacer member is in contact with the second spacer member when the spacer is in the first configuration. The first spacer member is spaced apart from the second spacer member by a non-zero distance when the spacer is in the second configuration. This arrangement can, for example, allow for the insertion of bone material and/or bone growth enhancing substances between the first spacer member and the second spacer member.
• In some embodiments, a disc implant can include one or more components having mating surfaces that are non-parallel to and non-normal to a longitudinal axis of the implant. For example, in some embodiments, a disc implant can include a spacer and an actuator. The spacer defines a longitudinal axis and has a first spacer member and a second spacer member. The first spacer member is configured to engage an endplate of a first vertebra, and has a first surface and a second surface. An axis within a plane defined by the first surface of the first spacer member is non-parallel to and non-normal to the longitudinal axis. An axis within a plane defined by the second surface of the first spacer member is non-parallel to and non-normal to the longitudinal axis. The second spacer member is configured to engage an endplate of a second vertebra, the second vertebra being adjacent the first vertebra. The second spacer member has a first surface and a second surface. An axis within a plane defined by the first surface of the second spacer member is non-parallel to and non-normal to the longitudinal axis. An axis within a plane defined by the second surface of the second spacer member is non-parallel to and non-normal to the longitudinal axis. The actuator has a first actuator member and a second actuator member movably coupled to the first actuator member. A first surface of the first actuator member is in contact with and substantially parallel to the first surface of the first spacer member. A second surface of the first actuator member is in contact with and substantially parallel to the first surface of the second spacer member. A first surface of the second actuator member is in contact with and substantially parallel to the second surface of the first spacer member. A second surface of the second actuator member is in contact with and substantially parallel to the second surface of the second spacer member. The actuator is configured to move the spacer between a first configuration and a second configuration. The first spacer member is in contact with the second spacer member when the spacer is in the first configuration. The first spacer member is spaced apart from the second spacer member by a non-zero distance when the spacer is in the second configuration.
• In some embodiments, an apparatus includes a spacer and an actuator. The spacer defines a longitudinal axis and has a first spacer member configured to engage an endplate of a first vertebra, and a second spacer member configured to engage an endplate of a second vertebra. The first spacer member has a first surface and a second surface. The second spacer member has a first surface and a second surface. The actuator has a first actuator member and a second actuator member movably coupled to the first actuator member. A first surface of the first actuator member is matingly and movably coupled to the first surface of the first spacer member. A second surface of the first actuator is matingly and movably coupled to the first surface of the second spacer member. A first surface of the second actuator member is matingly and movably coupled to the second surface of the first spacer member. A second surface of the second actuator member is matingly and movably coupled to the second surface of the second spacer member. The actuator is configured to move the spacer between a first configuration and a second configuration. The spacer has a first size along a first axis substantially normal to the longitudinal axis and a second size along a second axis substantially normal to the longitudinal axis and substantially normal to the first axis. The first size when the spacer is in the second configuration is greater than the first size when the spacer is in the first configuration. The second size when the spacer is in the second configuration is substantially equal to the second size when the spacer is in the first configuration.
• FIGS. 45 and 46 are schematic illustrations of animplant400 according to an embodiment, in a first configuration and a second configuration, respectively. As shown, theimplant400 is configured to be disposed within a disc space DS. The disc space DS is bounded by a first endplate EP1, a second endplate EP2, and an annulus fibrosis AF of the disc (shown by the dashed lines inFIGS. 45 and 46). Theimplant400 includes aspacer440 and anactuator405. Thespacer440 has afirst spacer member441 and asecond spacer member451, and defines a center line C_L. The center line C_Lcan be, for example, parallel to a longitudinal axis of thespacer440. As shown inFIG. 46, thefirst spacer member441 is configured to engage the first endplate EP1. Similarly, the second spacer member551 is configured to engage the second endplate EP2.
• Theactuator405 has afirst actuator member411 and asecond actuator member482 coupled to thefirst actuator member411. As shown inFIGS. 45 and 46, thefirst actuator member411 is matingly and movably coupled to thefirst spacer member441 and thesecond spacer member451. Similarly, thesecond actuator member482 is matingly and movably coupled to thefirst spacer member441 and thesecond spacer member451. Thefirst actuator member411 and/or thesecond actuator member482 can be matingly coupled to thefirst spacer member441 and/or thesecond spacer member451 in any suitable manner. For example, in some embodiments, thefirst actuator member411 and/or thesecond actuator member482 can include a dovetail protrusion and/or dovetail groove, of the types shown and described above, configured to matingly engage a dovetail protrusion and/or dovetail groove of thefirst spacer member441 and/or thesecond spacer member451. In this manner, thefirst spacer member441 and/or thesecond spacer member451 can be maintained in movable contact with thefirst actuator member411 and/or thesecond actuator member482. Similarly stated, such an arrangement allows thefirst spacer member441 and/or thesecond spacer member451 to remain in sliding contact with thefirst actuator member411 and/or thesecond actuator member482 over a range of motion. Said another way, such an arrangement prevents movement of thefirst spacer member441 and/or thesecond spacer member451 in a first direction relative to thefirst actuator member411 and/or thesecond actuator member482 while allowing movement of thefirst spacer member441 and/or thesecond spacer member451 in a second direction relative to thefirst actuator member411 and/or thesecond actuator member482.
• Theactuator405 is configured to move thespacer440 between a first configuration (FIG. 45) and a second configuration (FIG. 46). Theactuator405 can move thespacer440 between the first configuration and the second configuration by any suitable mechanism. For example, in some embodiments, theactuator405 can include a biasing member configured to move thespacer440 between the first configuration and the second configuration. In other embodiments, theactuator405 can move between a first position and a second position (not shown inFIGS. 45 and 46) to move thespacer440 between the first configuration and the second configuration. In yet other embodiments, thefirst actuator member411 can be configured to move relative to thesecond actuator member482 to move thespacer440 between the first configuration and the second configuration.
• As shown inFIG. 45, thefirst spacer member441 is in contact with thesecond spacer member451 when thespacer440 is in the first configuration. More particularly, asurface447 of thefirst spacer member441 is in contact with asurface457 of thesecond spacer member451 when thespacer440 is in the first configuration. Moreover, thespacer440 has a first size S1 along an axis substantially normal to the center line C_L(e.g., a vertical axis as shown inFIG. 45) when thespacer440 is in the first configuration.
• When theactuator405 moves thespacer440 from the first configuration to the second configuration, thefirst spacer member441 moves relative to thesecond spacer member451 in a direction substantially normal to the center line C_L, as shown by the arrow GGG inFIG. 46. Similarly stated, when theactuator405 moves thespacer440 from the first configuration to the second configuration, thesecond spacer member451 moves relative to thefirst spacer member441 in a direction substantially normal to the center line C_L, as shown by the arrow HHH inFIG. 46. Said another way, when theactuator405 moves thespacer440 from the first configuration to the second configuration, thefirst spacer member441 is moved apart from thesecond spacer member451.
• Accordingly, when thespacer440 is in the second configuration, thefirst spacer member441 is spaced apart from thesecond spacer member451 by a non-zero distance. Said another way, a lower portion of thesurface447 of thefirst spacer member441 is spaced apart from an upper portion of thesurface457 of thesecond spacer member451 by a non-zero distance d when thespacer440 is in the second configuration. Said yet another way, thefirst spacer member441 and thesecond spacer member451 collectively define anopening450 when thespacer440 is in the second configuration. In this manner, bone material and/or bone growth enhancing substances can be disposed between thefirst spacer member441 and the second spacer member451 (e.g., within the opening450) when thespacer440 is in the second configuration. Also, bone growth can occur through theopening450, promoting better fusion between the end plate EP1 and the end plate EP2.
• Moreover, thespacer440 has a second size S2 along the axis substantially normal to the center line C_L, greater than the size S1, when thespacer440 is in the second configuration. Similarly stated, the size of thespacer440 along at least one axis is increased when thespacer440 is moved from the first configuration to the second configuration. Accordingly, in use, theimplant400 can be inserted into the disc space DS when theimplant400 is in the first configuration (see e.g.,FIG. 45). For example, a user can insert theimplant400 percutaneously (e.g., through a cannula, over a guide wire, or the like) into a body of a patient. In some embodiments, a tool, such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety can be used to insert theimplant400 into a body of a patient and/or actuate theimplant400, as described above.
• In some embodiments, thespacer440 can be repeatedly moved between the first configuration and the second configuration. In this manner, a user can remove theimplant400 from and/or reposition theimplant400 within the body in a minimally-invasive manner.
• In use,implant400 can be inserted percutaneously into a disc space (not shown). In this manner, theimplant400 can be used, for example, as a fusion cage. Theimplant400 can be inserted when in the first configuration, by, for example, an insertion tool as shown and described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. Once in the disc space, theimplant400 can be moved from the first configuration to the second configuration. In this manner, thefirst spacer member441 and thesecond spacer member451 can distract and/or maintain a minimal spacing of the disc space. More particularly, thefirst spacer member441 and thesecond spacer member451 can contact the vertebral endplates to stabilize the spinal segment within which theimplant400 is disposed.
• FIGS. 47-60 show animplant1200, according to an embodiment.Implant1200 includes adistal end portion1210, acentral portion1240 and aproximal end portion1280. Thecentral portion1240 is disposed between thedistal end portion1210 and theproximal end portion1280. Theimplant1200 defines a lumen1246 (seeFIG. 54) and includes adrive screw1283 disposed within thelumen1246. Thedrive screw1283 has atool head1284 configured to mate with and/or receive a tool for rotating thedrive screw1283, as described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety.
• Thedistal end portion1210 ofimplant1200 includes anactuator1211, a first distalintermediate member1220 and a second distalintermediate member1230.Actuator1211 includes a taperedsurface1212, a threaded portion1214 (seeFIG. 55), afirst engagement surface1216, asecond engagement surface1217, afirst protrusion1218 and asecond protrusion1219. The threadedportion1214 is disposed fixedly within thelumen1246 and is configured to receive thedrive screw1283. In other embodiments, the insertion member can include a captive nut configured to receive thedrive screw1283.
• Thefirst engagement surface1216 of theactuator1211 is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 0 degrees and 90 degrees. Similarly, thesecond engagement surface1217 of theactuator1211 is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 0 degrees and 90 degrees. As described above, the angular offset of theengagement surfaces1216 and1217 are associated with moving theimplant1200 between a first configuration (FIG. 47) and a second configuration (FIG. 48). More particularly, the angular offsets of theengagement surfaces1216 and1217 are associated with the force to move theimplant1200 between the first configuration and the second configuration. The angular offsets of the of theengagement surfaces1216 and1217 are also associated with the distance through which various components of theimplant1200 are moved when theimplant1200 is moved between the first configuration and the second configuration. Although theengagement surfaces1216 and1217 are shown and described as being non-parallel to and non-normal to the longitudinal axis A_Lof theimplant1200, in other embodiments, theengagement surfaces1216 and1217 can be substantially parallel to or substantially normal to the longitudinal axis A_Lof theimplant1200.
• As shown inFIG. 57, thefirst protrusion1218 of theactuator1211 has an undercut such that the first distalintermediate member1220 can be slidably coupled to theactuator1211. More particularly, thefirst protrusion1218 has a trapezoidal cross-sectional shape. In this embodiment, thefirst protrusion1218 is a dovetail protrusion. Similarly, thesecond protrusion1219 of theactuator1211 has an undercut such that the second distalintermediate member1230 can be slidably coupled to theactuator1211. More particularly, thesecond protrusion1219 has a trapezoidal cross-sectional shape. In this embodiment, thesecond protrusion1219 is a dovetail protrusion.
• The first distalintermediate member1220 includes afirst engagement surface1222, asecond engagement surface1223 opposite thefirst engagement surface1222 and aprotrusion1226. The first distalintermediate member1220 defines a notch1228 (seeFIG. 59) configured to allow thedrive screw1283 to pass through the first distalintermediate member1220 when theimplant1200 is in the first configuration. Said another way, when theimplant1200 is in the first configuration, thenotch1228 is aligned with thelumen1246.
• Theprotrusion1226 of the first distalintermediate member1220 extends from thesecond engagement surface1223 and has a trapezoidal cross-sectional shape. In this embodiment, theprotrusion1226 is a dovetail protrusion configured to matingly and movably couple the firstcentral support member1241 of thecentral portion1240 to the first distalintermediate member1220.
• Thefirst engagement surface1222 of the first distalintermediate member1220 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 90 degrees and 180 degrees. Moreover, thefirst engagement surface1222 of the first distalintermediate member1220 is substantially parallel to theengagement surface1216 of theactuator1211. Said another way, the angular offset of thefirst engagement surface1222 of thedistal retention member1220 is supplementary with the angular offset of theengagement surface1216 of theactuator1211.
• Thefirst engagement surface1222 of the first distalintermediate member1220 defines agroove1224 having a trapezoidal cross-sectional shape. In this embodiment, thegroove1224 has a dovetail shape that corresponds to the shape of thefirst protrusion1218 of theactuator1211. Accordingly, the first distalintermediate member1220 and theactuator1211 are matingly and movably coupled by thegroove1224 and thefirst protrusion1218. Similarly stated, thegroove1224 and thefirst protrusion1218 are collectively configured to limit movement of the first distalintermediate member1220 relative to theactuator1211 in a direction substantially normal to thefirst engagement surface1222 of the first distalintermediate member1220. Moreover, thegroove1224 and thefirst protrusion1218 of theactuator1211 collectively allow movement of the first distalintermediate member1220 relative to theactuator1211 in a direction substantially parallel to thefirst engagement surface1222 of the first distalintermediate member1220.
• Thesecond engagement surface1223 of the first distalintermediate member1220 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 0 degrees and 90 degrees. Accordingly, the first distalintermediate member1220 is slidably disposed against the firstcentral support member1241 of thecentral portion1240.
• The second distalintermediate member1230 includes afirst engagement surface1232, asecond engagement surface1233 opposite thefirst engagement surface1232, and aprotrusion1236. Theprotrusion1236 of the second distalintermediate member1230 extends from thesecond engagement surface1233 and has a trapezoidal cross-sectional shape. In this embodiment, theprotrusion1236 is a dovetail protrusion configured to matingly and movably couple the secondcentral support member1251 of thecentral portion1240 to the second distalintermediate member1230.
• Additionally, the second distalintermediate member1230 defines a notch1238 configured to allow thedrive screw1283 to pass through the second distalintermediate member1230 when theimplant1200 is in the first configuration. Moreover, thefirst engagement surface1232 of the second distalintermediate member1230 defines agroove1234. The second distalintermediate member1230 is configured similar to the first distalintermediate member1220, and is therefore not described in detail herein.
• Proximal end portion1280 ofimplant1200 includes atool engagement member1282, a first proximalintermediate member1260 and a second proximalintermediate member1270.Tool engagement member1282 is configured to mate with and/or receive an insertion tool, such as those described herein.Tool engagement member1282 includes afirst engagement surface1286, asecond engagement surface1287, afirst protrusion1288 and asecond protrusion1289.
• Thefirst engagement surface1286 of thetool engagement member1282 is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 0 degrees and 90 degrees. Similarly, thesecond engagement surface1287 of thetool engagement member1282 is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 0 degrees and 90 degrees.
• Thefirst protrusion1288 of thetool engagement member1282 has an undercut such that the first proximalintermediate member1260 can be slidably coupled to thetool engagement member1282. More particularly, thefirst protrusion1288 has a trapezoidal cross-sectional shape. In this embodiment, thefirst protrusion1288 is a dovetail protrusion. Similarly, thesecond protrusion1289 of thetool engagement member1282 has an undercut such that the second proximalintermediate member1270 can be slidably coupled to thetool engagement member1282.
• The first proximalintermediate member1260 includes afirst engagement surface1262, asecond engagement surface1263 opposite thefirst engagement surface1262 and aprotrusion1266. The first proximalintermediate member1260 defines anotch1268 configured to allow thedrive screw1283 to pass through the first proximalintermediate member1260 when theimplant1200 is in the first configuration. Said another way, when theimplant1200 is in the first configuration, thenotch1268 is aligned with thelumen1246.
• Theprotrusion1266 of the first proximalintermediate member1260 extends from thesecond engagement surface1263 and has a trapezoidal cross-sectional shape. In this embodiment, theprotrusion1266 is a dovetail protrusion configured to matingly and movably couple the firstcentral support member1241 of thecentral portion1240 to the first proximalintermediate member1260.
• Thefirst engagement surface1262 of the first proximalintermediate member1260 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 90 degrees and 180 degrees. Moreover, thefirst engagement surface1262 of the first proximalintermediate member1260 is substantially parallel to thefirst engagement surface1286 of thetool engagement member1282.
• Thefirst engagement surface1262 of the first proximalintermediate member1260 defines agroove1264 having a trapezoidal cross-sectional shape. In this embodiment, thegroove1264 has a dovetail shape that corresponds to the shape of thefirst protrusion1288 of thetool engagement member1282. Accordingly, the first proximalintermediate member1260 and thetool engagement member1282 are matingly and movably coupled by thegroove1264 and thefirst protrusion1288. Similarly stated, thegroove1264 and thefirst protrusion1288 are collectively configured to limit movement of the first proximalintermediate member1260 relative to thetool engagement member1282 in a direction substantially normal to thefirst engagement surface1262 of the first proximalintermediate member1260. Moreover, thegroove1264 and thefirst protrusion1288 of thetool engagement member1282 collectively allow movement of the first proximalintermediate member1260 relative to thetool engagement member1282 in a direction substantially parallel to thefirst engagement surface1262 of the first proximalintermediate member1260.
• Thesecond engagement surface1263 of the first proximalintermediate member1260 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 0 degrees and 90 degrees. Accordingly, the first proximalintermediate member1260 is slidably disposed against the firstcentral support member1241 of thecentral portion1240.
• The second proximalintermediate member1270 includes afirst engagement surface1272, asecond engagement surface1273 opposite thefirst engagement surface1272, and aprotrusion1276. Theprotrusion1276 of the second proximalintermediate member1270 extends from thesecond engagement surface1273 and has a trapezoidal cross-sectional shape. In this embodiment, theprotrusion1276 is a dovetail protrusion configured to matingly and movably couple the secondcentral support member1251 of thecentral portion1240 to the second proximalintermediate member1270.
• Additionally, the second proximalintermediate member1270 defines a notch configured to allow thedrive screw1283 to pass through the second proximalintermediate member1270 when theimplant1200 is in the first configuration. Moreover, thefirst engagement surface1272 of the second proximalintermediate member1270 defines a groove. The second proximalintermediate member1270 is configured similar to the first proximalintermediate member1260, and is therefore not described in detail herein.
• Thecentral portion1240 ofimplant1200 includes a firstcentral support member1241 and a secondcentral support member1251. The firstcentral support member1241 includes aproximal engagement surface1242 and adistal engagement surface1243. The firstcentral support member1241 defines anotch1246 configured to allow thedrive screw1283 to pass through the firstcentral support member1241 when theimplant1200 is in the first configuration. Said another way, when theimplant1200 is in the first configuration, thenotch1246 is aligned with thelumen1246.
• Thedistal engagement surface1243 of the firstcentral support member1241 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 90 degrees and 180 degrees. Moreover, the angular offset of thedistal engagement surface1243 of the firstcentral support member1241 is supplementary with the angular offset of thesecond engagement surface1223 of the first distalintermediate member1220. Accordingly, the firstcentral support member1241 is slidably disposed against the first distalintermediate member1220.
• Moreover, thedistal engagement surface1243 of the firstcentral support member1241 defines adistal groove1245. Thedistal groove1245 is configured to receive and to slide along theprotrusion1226 of the first distalintermediate member1220. The trapezoidal cross-section of theprotrusion1226 of the first distalintermediate member1220 slidably maintains theprotrusion1226 of the first distalintermediate member1220 within thedistal groove1245. Thedistal engagement surface1243 of the firstcentral support member1241 contacts and is configured to slide along thesecond engagement surface1223 of the first distalintermediate member1220 when thedistal groove1245 slides along theprotrusion1226 of the first distalintermediate member1220.
• Theproximal engagement surface1242 of the firstcentral support member1241 defines a plane that is angularly offset from the longitudinal axis A_Lof theimplant1200 by an angle between 90 degrees and 180 degrees. Moreover, the angular offset of theproximal engagement surface1242 of the firstcentral support member1241 is supplementary with the angular offset of thesecond engagement surface1263 of the first proximalintermediate member1260. Accordingly, the firstcentral support member1241 is slidably disposed against the first proximalintermediate member1260.
• Moreover, theproximal engagement surface1242 of the firstcentral support member1241 defines aproximal groove1244. Theproximal groove1244 is configured to receive and to slide along theprotrusion1266 of the first proximalintermediate member1260. The trapezoidal cross-section of theprotrusion1266 of the first proximalintermediate member1260 slidably maintains theprotrusion1266 of the first proximalintermediate member1260 within theproximal groove1244. Theproximal engagement surface1242 of the firstcentral support member1241 contacts and is configured to slide along thesecond engagement surface1263 of the first proximalintermediate member1260 when theproximal groove1244 slides along theprotrusion1266 of the first proximalintermediate member1260.
• Likewise, the secondcentral support member1251 of thecentral portion1240 includes aproximal engagement surface1252 and adistal engagement surface1253. The secondcentral support member1251 defines anotch1256 configured to allow thedrive screw1283 to pass through the secondcentral support member1251 when theimplant1200 is in the first configuration. Theproximal engagement surface1252 defines aproximal groove1254 and thedistal engagement surface1253 defines adistal groove1255. The secondcentral support member1251 is configured similar to the firstcentral support member1241 described above.
• Implant1200 has multiple configurations.FIG. 47 shows theimplant1200 in a first configuration. In the first configuration, theproximal end portion1280, thedistal end portion1210 and thecentral portion1240 are substantially coaxial (i.e., substantially share a common longitudinal axis). Moreover, the firstcentral support member1241 is in contact with the secondcentral support member1251.
• Theimplant1200 can be moved from the first configuration to a second configuration as illustrated inFIG. 48. In the second configuration the first distalintermediate member1220, the second distalintermediate member1230, the first proximalintermediate member1260, the second proximalintermediate member1270, the firstcentral support member1241 and/or the secondcentral support member1251 can be offset from theactuator1211 and thetool engagement member1282.
• In use,implant1200 can be inserted percutaneously into a disc space (not shown inFIGS. 47-60). In this manner, theimplant1200 can be used, for example, as a fusion cage. Accordingly, in some embodiments, various portions of the implant1200 (e.g., the outer surfaces of the central element1240) can include features to enhance its biomechanical performance. Such features can include, for example, holes and/or textured surfaces within which bone material and/or bone growth enhancing substances can be disposed.
• Theimplant1200 can be inserted when in the first configuration, by, for example, an insertion tool as shown herein. Thedistal end portion1210 can be inserted first and is moved past the center of the disc space until at least thecentral portion1240 is positioned within the disc space. Once in the disc space, theimplant1200 can be moved from the first configuration to the second configuration. In the second configuration, the first and second proximalintermediate members1260,1270 and the first and second distalintermediate members1220,1230 can be offset from theactuator1211 and thetool engagement member1282. This causes the firstcentral support member1241 of thecentral portion1240 and the secondcentral support member1251 of thecentral portion1240 to move in relation to theactuator1211 and thetool engagement member1282 as further described herein. In this manner, the firstcentral support member1241 and the secondcentral support member1251 can distract and/or maintain a minimal spacing of the disc space. More particularly, the firstcentral support member1241 and the secondcentral support member1251 can contact the vertebral endplates to stabilize the spinal segment within which theimplant1200 is disposed.
• To move theimplant1200 from the first configuration to the second configuration, thedrive screw1283 is rotated within theactuator1211. In some embodiments, thedrive screw1283 can be rotated by an insertion tool such as those described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. The insertion tool (not shown) can be configured to be removably coupled to thetool engagement member1282 such that rotation of thetool engagement member1282 relative to the insertion tool about the longitudinal axis A_Lis limited. In some embodiments, the insertion tool can be configured to be removably coupled to thetool engagement member1282 such that axial movement of thetool engagement member1282 relative to the insertion tool is limited. In some embodiments, for example, the insertion tool can be coupled to an outer surface of thetool engagement member1282. In such embodiments, the outer surface of thetool engagement member1282 can be configured to facilitate the docking of the insertion tool (not shown) to theimplant1200. For example, in some embodiments, the outer surface of thetool engagement member1282 can include a lead-in chamfer, a tapered portion and/or a beveled edge to facilitate the docking of the insertion to onto thetool engagement member1282 of theimplant1200. In other embodiments, the insertion tool can be matingly coupled to a protrusion and/or a recess of thetool engagement member1282. The insertion tool can include an actuator configured to be inserted into thetool head1284 of thedrive screw1283 to rotate thedrive screw1283 about the longitudinal axis A_L. This arrangement allows thedrive screw1283 to be rotated without rotating the other portions of theimplant1200.
• When thedrive screw1283 is rotated as indicated by the arrow CC inFIG. 49, thedrive screw1283 moves theactuator1211 relative to thetool engagement member1282, and towards thecentral portion1240. Accordingly, thefirst engagement surface1216 of theactuator1211 exerts a force on thefirst engagement surface1222 of the first distalintermediate member1220, and thesecond engagement surface1217 of theactuator1211 exerts a force on thefirst engagement surface1232 of the second distalintermediate member1230. These forces cause the first distalintermediate member1220 to slide on thefirst engagement surface1216 of theactuator1211 causing the first distalintermediate member1220 to move in the direction AA (seeFIG. 50), and the second distalintermediate member1230 to slide on thesecond engagement surface1217 of theactuator1211 causing the second distalintermediate member1230 to move in the direction BB.
• Similarly, when thedrive screw1283 is rotated as indicated by the arrow CC inFIG. 49, thefirst engagement surface1286 of thetool engagement member1282 exerts a force on thefirst engagement surface1262 of the first proximalintermediate member1260 and thesecond engagement surface1287 of thetool engagement member1282 exerts a force on thefirst engagement surface1272 of the second proximalintermediate member1270. These forces cause the first proximalintermediate member1260 to slide on thefirst engagement surface1286 of thetool engagement member1282 causing the first proximalintermediate member1260 to move in the direction AA, and the second proximalintermediate member1270 to slide on thesecond engagement surface1287 of thetool engagement member1282 causing the second proximalintermediate member1270 to move in the direction BB.
• As the first distalintermediate member1220 slides on thefirst engagement surface1216 of theactuator1211, thesecond engagement surface1223 of the first distalintermediate member1220 exerts a force on thedistal engagement surface1243 of the firstcentral support member1241 of thecentral portion1240. Likewise, as the first proximalintermediate member1260 slides on thefirst engagement surface1286 of thetool engagement portion1282, thesecond engagement surface1263 of the first distalintermediate member1260 exerts a force on theproximal engagement surface1242 of the firstcentral support member1241 of thecentral portion1240. The force exerted on thedistal engagement surface1243 of the firstcentral support member1241 and the force exerted on theproximal engagement surface1242 of the firstcentral support member1241 cause the firstcentral support member1241 to move in the direction AA.
• Furthermore, as the second distalintermediate member1230 slides on thesecond engagement surface1217 of theactuator1211, thesecond engagement surface1233 of the second distalintermediate member1230 exerts a force on thedistal engagement surface1253 of the secondcentral support member1251 of thecentral portion1240. Likewise, as the second proximalintermediate member1270 slides on thesecond engagement surface1287 of thetool engagement portion1282, thesecond engagement surface1273 of the second distalintermediate member1270 exerts a force on theproximal engagement surface1252 of the secondcentral support member1251 of thecentral portion1240. The force exerted on thedistal engagement surface1253 of the secondcentral support member1251 and the force exerted on theproximal engagement surface1252 of the secondcentral support member1251 causes the secondcentral support member1251 to move in the direction AA.
• To remove and/or reposition theimplant1200, thedrive screw1283 is rotated as indicated by the arrow DD inFIG. 49, by for example, a removal tool (may be similar to an insertion tool). Rotating thedrive screw1283 in direction DD, causes the dovetail configuration of theprotrusions1218,1219 of theactuator1211 and the dovetail configurations of theprotrusions1288,1289 of thetool engagement member1282 to pull the distalintermediate members1220,1230 and the proximalintermediate members1260,1270 back into the first configuration. This causes the dovetail configurations of theprotrusions1226,1236 of the distalintermediate members1220,1230 and the dovetail configurations of theprotrusions1266,1276 of the proximalintermediate members1260,1270 to pull thesupport members1241,1251 back into the first configuration.
• Although theimplant1200 is shown is being movable between a first configuration (FIG. 49) and a second configuration (FIG. 50), theimplant1200 can be maintained in any number of different configurations. For example, theimplant1200 can be maintained in any suitable configuration between the first configuration and the second configuration. Said another way, theimplant1200 can be placed in an infinite number of different configurations between the first configuration and the second configuration. Thus, the disc space can be distracted by the firstcentral support member1241 and the secondcentral support member1251 by any desired amount within a predetermined range. In this manner, asingle implant1200 can be used to treat a wide range of conditions and/or locations within the body requiring different amounts of distraction. Moreover, this arrangement allows the amount of distraction to be varied in situ over time.
• For example, in some embodiments, the amount of distraction can be varied within a range of approximately 8 mm to 16 mm. Within this range, the size of thecentral portion1240 can be adjusted to any desired amount by rotating the drive screw1283 a predetermined amount, as described above. In other embodiments, the range of distraction can be approximately 4 mm (e.g., a range from 5 mm to 9 mm, a range from 12 mm to 16 mm, or the like). In yet other embodiments, the range of distraction can be approximately 3 mm (e.g., a range from 10 mm to 13 mm, a range from 12 mm to 15 mm, or the like).
• FIGS. 61-63 show animplant2200 according to an embodiment. Theimplant2200 is structured like and functions similar to theimplant1220 without intermediate members2220,2230,2260 and2270, but with a single central support member.FIG. 61 shows various views of theimplant2200 in a first configuration and a second configuration.FIGS. 62 and 63 show exploded views of theimplant2200. In use,implant2200 is inserted percutaneously into a disc space (not shown inFIGS. 61-63), in the first configuration, by, for example, an insertion tool as described in U.S. patent application Attorney Docket No. KYPH-040/02US 305363-2272 entitled “Tools and Methods for insertion and Removal of Medical Implants,” which is incorporated herein by reference in its entirety. Theimplant2200 can then be moved into the second configuration to maintain a minimal spacing of the disc space. Theimplant2200 may also be used as a distraction tool; in such a use, theimplant2200 can be moved into the second configuration to move the spinous processes.
• The various implants, deployment/insertion tools, and guide members described herein can be constructed with various biocompatible materials such as, for example, titanium, titanium alloyed, surgical steel, biocompatible metal alloys, stainless steel, plastic, polyetheretherketone (PEEK), carbon fiber, ultra-high molecular weight (UHMW) polyethylene, biocompatible polymeric materials, etc. The material of a central portion of the implant can have, for example, a compressive strength similar to or higher than that of bone. In one embodiment, the central portion of the implant, which is placed between the two adjacent spinous processes, is configured with a material having an elastic modulus higher than the elastic modulus of the bone, which forms the spinous processes. In another embodiment, the central portion of the implant is configured with a material having a higher elastic modulus than the materials used to configure the distal and proximal portions of the implant. For example, the central portion of the implant may have an elastic modulus higher than bone, while the proximal and distal portions have a lower elastic modulus than bone. In yet another embodiment, the implant is configured with an outer shell and an inner core. The outer shell can be configured with material having a higher elastic modulus than the inner core (e.g., outer shell is made with titanium alloyed, while the inner core is made with a polymeric material). Alternatively, the outer shell can be configured with a material having a lower elastic modulus than the inner core (e.g., the outer shell is made with a polymeric material while the inner core is made with a titanium alloyed material).
• While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.
• Although theinterspinous process implant1100 and thedisc implant1200 are shown and described as including protrusions and grooves configured to matingly couple various components thereof, in other embodiments, an interspinous process implant and/or a disc implant need not include components that are matingly coupled. For example, in some embodiments, a disc implant can include an actuator configured to actuate a spacer that is devoid of mating protrusions and/or grooves. Similarly, in some embodiments, an interspinous process implant can include an actuator configured to actuate a retention member that is devoid of mating protrusions and/or grooves. For example, in such embodiments, a retention member can be magnetically coupled to the actuator.
• Although the engagement surfaces are shown and described above as being planar, in some embodiments, an implant can include an engagement surface that is curved.
• In some embodiments, the implants shown and described can be biased in the first configuration or the second configuration. For example in some embodiments, an implant can include a spring and/or the like to bias a portion of the implant as desired. Additionally, in some embodiments an implant can include a locking member to temporally maintain the implant in a particular configuration. Similarly stated, in some embodiments an implant can include a locking member configured to temporally maintain the implant in the first configuration if the implant is biased to be in the second configuration, and vise versa. For example, a locking member can be disposed within a retention member such that an end portion of the locking member is received within a recess of a central body to temporarily maintain the implant in a first and/or a second configuration. In other embodiments, an implant can include a first locking member or detent to temporarily maintain the implant in a first configuration and/or a second locking member or detent to temporarily maintain the implant in a second configuration.
• As discussed herein, the implants shown and described above can be inserted into the body percutaneously and/or in a minimally-invasive manner. For example, in some embodiments, an implant of the types shown and described above can be inserted through a skin incision of less than 20 mm in length. In other embodiments, an implant of the types shown and described above can be inserted through a skin incision of less than 15 mm in length. In yet other embodiments, an implant of the types shown and described above can be inserted through a skin incision of less than 10 mm in length.
• Although many of the implants shown and described above include components (e.g., an actuator) having a dovetail protrusion configured to be matingly and movably coupled to other components (e.g., a retention member or spacer) having a dovetail groove, it should be understood that either component can include the protrusion and/or the groove. Moreover, although the protrusions and/or grooves are described above as being dovetail protrusions and/or grooves, in other embodiments, an implant can include components that are matingly and movably coupled together by any suitable type of protrusion and groove. For example,FIGS. 64-66 show examples of protrusions and grooves that can be used to matingly and movably couple components of any of the implants described herein.FIG. 64 shows afirst implant component10 matingly and movably coupled to asecond implant component20. Thefirst implant component10 has aprotrusion12 having an undercut14. Thesecond implant20 defines agroove22 having an undercut24. Theprotrusion12 is disposed within thegroove22 such that thefirst implant component10 can move relative to the second implant component20 (e.g., in a direction normal to the plane shown inFIG. 64), while remaining coupled together.
• FIG. 65 shows afirst implant component10′ matingly and movably coupled to asecond implant component20′. Thefirst implant component10′ has acurved protrusion12′ having an undercut14′. Thesecond implant20′ defines agroove22′ having a curved shape and having an undercut24′. Theprotrusion12′ is disposed within thegroove22′ such that thefirst implant component10′ can move relative to thesecond implant component20′ (e.g., in a direction normal to the plane shown inFIG. 65), while remaining coupled together.
• FIG. 66 shows afirst implant component10″ matingly and movably coupled to asecond implant component20″. Thefirst implant component10″ has acircular protrusion12″ having an undercut14″. Theprotrusion12″ can also be a substantially spherical protrusion. Thesecond implant20″ defines agroove22″ having a circular (or substantially spherical) shape and having an undercut24″. Theprotrusion12″ is disposed within thegroove22″ such that thefirst implant component10″ can move relative to thesecond implant component20″ (e.g., in a direction normal to the plane shown inFIG. 66), while remaining coupled together.
• Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments where appropriate. For example, in some embodiments, a disc implant similar to theimplant1200 can include a tool engagement portion similar to the tool engagement portion of theimplant3100.

Claims (26)

1. An apparatus, comprising:

a spacer having a first spacer member configured to engage an endplate of a first vertebra and a second spacer member configured to engage an endplate of a second vertebra, the second vertebra adjacent the first vertebra; and

an actuator having a first actuator member and a second actuator member coupled to the first actuator member, the first actuator member being matingly and movably coupled to the first spacer member, the first actuator being matingly and movably coupled to the second spacer member, the second actuator member being matingly and movably coupled to the first spacer member, the second actuator member being matingly and movably coupled to the second spacer member,

the actuator configured to move the spacer between a first configuration and a second configuration, the first spacer member being in contact with the second spacer member when the spacer is in the first configuration, the first spacer member being spaced apart from the second spacer member by a non-zero distance when the spacer is in the second configuration.

2. The apparatus ofclaim 1, wherein:

the first spacer member has a first surface and a second surface, the second spacer member having a first surface and a second surface;

a first surface of the first actuator member is matingly and movably coupled to the first surface of the first spacer member, a second surface of the first actuator is matingly and movably coupled to the first surface of the second spacer member; and

a first surface of the second actuator member is matingly and movably coupled to the second surface of the first spacer member, a second surface of the second actuator member is matingly and movably coupled to the second surface of the second spacer member.

3. The apparatus ofclaim 1, wherein the first spacer member and the second spacer member collectively define an opening when the spacer is in the second configuration.

4. The apparatus ofclaim 1, wherein a first surface of the first actuator member is matingly and movably coupled to a first surface of the first spacer member such that the first actuator member remains in sliding contact with the first spacer member over a range of motion.

5. The apparatus ofclaim 1, wherein a first surface of the first actuator member is matingly and movably coupled to a first surface of the first spacer member such that movement of the first spacer member relative to first actuator member in direction substantially normal to the first surface of the first actuator member is limited.

6. The apparatus ofclaim 1, wherein:

a first surface of the first spacer member defines a groove having a trapezoidal cross-sectional shape; and

a first surface of the first actuator member includes a protrusion having a trapezoidal cross-sectional shape, the protrusion configured to be matingly received within the groove such that the first surface of the first actuator member is matingly and movably coupled to the first surface of the first spacer member.

7. The apparatus ofclaim 1, wherein:

a first surface of the first spacer member defines a first groove, a second surface of the first spacer member defines a second groove;

a first surface of the first actuator member has a protrusion configured to be matingly received within the first groove, the first groove and the protrusion of the first surface of the first actuator member collectively configured to limit movement of the first spacer member relative to the first actuator member in a direction substantially normal to the first surface of the first actuator member; and

a first surface of the second actuator member has a protrusion configured to be matingly received within the second groove, the second groove and the protrusion of the first surface of the second actuator member collectively configured to limit movement of the first spacer member relative to the second actuator member in a direction substantially normal to the first surface of the second actuator member.

8. The apparatus ofclaim 1, wherein:

a first surface of the first spacer member defines a groove, a second surface of the first spacer member defines a groove;

a first surface of the second spacer member defines a groove, a second surface of the second spacer member defines a groove;

a first surface of the first actuator member has a protrusion configured to be matingly received within the groove of the first surface of the first spacer member, the groove of the first surface of the first spacer member and the protrusion of the first surface of the first actuator member collectively configured to maintain the first actuator member in sliding contact with the first spacer member;

a first surface of the second actuator member has a protrusion configured to be matingly received within the groove of the second surface of the first spacer member, the groove of the second surface of the first spacer member and the protrusion of the first surface of the second actuator member collectively configured to maintain the second actuator member in sliding contact with the first spacer member;

a second surface of the first actuator member has a protrusion configured to be matingly received within the groove of the first surface of the second spacer member, the groove of the first surface of the second spacer member and the protrusion of the second surface of the first actuator member collectively configured to maintain the first actuator member in sliding contact with the second spacer member; and

a second surface of the second actuator member has a protrusion configured to be matingly received within the groove of the second surface of the second spacer member, the groove of the second surface of the second spacer member and the protrusion of the second surface of the second actuator member collectively configured to maintain the second actuator member in sliding contact with the second spacer member.

9. The apparatus ofclaim 1, wherein:

the first spacer member has a first surface and a second surface, an axis within a plane defined by the first surface of the first spacer member is non-parallel to and non-normal to a longitudinal axis of the spacer, an axis within a plane defined by the second surface of the first spacer member is non-parallel to and non-normal to the longitudinal axis;

a first surface of the first actuator member is matingly and movably coupled to the first surface of the first spacer member; and

a first surface of the second actuator member is matingly and movably coupled to the second surface of the first spacer member.

10. The apparatus ofclaim 1, wherein the first spacer member is configured to translate relative to the second spacer member in a direction substantially normal to a longitudinal axis of the spacer when the spacer is moved from the first configuration to the second configuration.

11. The apparatus ofclaim 1, wherein:

the spacer has a first size along a first axis substantially normal to a longitudinal axis of the spacer and a second size along a second axis substantially normal to the longitudinal axis and substantially normal to the first axis,

the first size when the spacer is in the second configuration being greater than the first size when the spacer is in the first configuration,

the second size when the spacer is in the second configuration being substantially equal to the second size when the spacer is in the first configuration.

12. An apparatus, comprising:

a spacer defining a longitudinal axis and having a first spacer member and a second spacer member, the first spacer member configured to engage an endplate of a first vertebra, the first spacer member having a first surface and a second surface, an axis within a plane defined by the first surface of the first spacer member being non-parallel to and non-normal to the longitudinal axis, an axis within a plane defined by the second surface of the first spacer member being non-parallel to and non-normal to the longitudinal axis,

the second spacer member configured to engage an endplate of a second vertebra, the second vertebra adjacent the first vertebra, the second spacer member having a first surface and a second surface, an axis within a plane defined by the first surface of the second spacer member being non-parallel to and non-normal to the longitudinal axis, an axis within a plane defined by the second surface of the second spacer member being non-parallel to and non-normal to the longitudinal axis; and

an actuator having a first actuator member and a second actuator member movably coupled to the first actuator member, a first surface of the first actuator member in contact with and substantially parallel to the first surface of the first spacer member, a second surface of the first actuator member in contact with and substantially parallel to the first surface of the second spacer member,

a first surface of the second actuator member in contact with and substantially parallel to the second surface of the first spacer member, a second surface of the second actuator member in contact with and substantially parallel to the second surface of the second spacer member,

the actuator configured to move the spacer between a first configuration and a second configuration, the first spacer member being in contact with the second spacer member when the spacer is in the first configuration, the first spacer member being spaced apart from the second spacer member by a non-zero distance when the spacer is in the second configuration.

13. The apparatus ofclaim 12, wherein the first spacer member and the second spacer member collectively define an opening when the spacer is in the second configuration.

14. The apparatus ofclaim 12, wherein the first surface of the first actuator member is matingly coupled to the first surface of the first spacer member.

15. The apparatus ofclaim 12, wherein the first surface of the first actuator member is matingly coupled to the first surface of the first spacer member such that the first actuator member remains in sliding contact with the first spacer member over a range of motion.

16. The apparatus ofclaim 12, wherein:

the first surface of the first spacer member defines a groove having a trapezoidal cross-sectional shape; and

the first surface of the first actuator member includes a protrusion having a trapezoidal cross-sectional shape, the protrusion configured to be matingly received within the groove.

17. The apparatus ofclaim 12, wherein the first spacer member translates relative to second spacer member in a direction substantially normal to the longitudinal axis when the spacer is moved from the first configuration to the second configuration.

18. The apparatus ofclaim 12, wherein:

the spacer has a first size along a first axis substantially normal to the longitudinal axis and a second size along a second axis substantially normal to the longitudinal axis and substantially normal to the first axis,

the first size when the spacer is in the second configuration being greater than the first size when the spacer is in the first configuration,

the second size when the spacer is in the second configuration being substantially equal to the second size when the spacer is in the first configuration.

19. The apparatus ofclaim 12, wherein the first spacer member and the second spacer member are collectively configured to distract the endplate of the first vertebra and the endplate of the second vertebra a distance of between approximately 8 millimeters and approximately 16 millimeters.

20. The apparatus ofclaim 12, wherein the actuator is configured to move the spacer between a plurality of configurations such that the first spacer member can be spaced apart from the second spacer member by a plurality of distances within between approximately 0 millimeters and approximately 4 millimeters.

21. An apparatus, comprising:

a spacer defining a longitudinal axis and having a first spacer member configured to engage an endplate of a first vertebra and a second spacer member configured to engage an endplate of a second vertebra, the second vertebra adjacent the first vertebra, the first spacer member having a first surface and a second surface, the second spacer member having a first surface and a second surface; and

an actuator having a first actuator member and a second actuator member movably coupled to the first actuator member, a first surface of the first actuator member being matingly and movably coupled to the first surface of the first spacer member, a second surface of the first actuator being matingly and movably coupled to the first surface of the second spacer member,

a first surface of the second actuator member being matingly and movably coupled to the second surface of the first spacer member, a second surface of the second actuator member being matingly and movably coupled to the second surface of the second spacer member,

the actuator configured to move the spacer between a first configuration and a second configuration, the spacer having a first size along a first axis substantially normal to the longitudinal axis and a second size along a second axis substantially normal to the longitudinal axis and substantially normal to the first axis, the first size when the spacer is in the second configuration being greater than the first size when the spacer is in the first configuration, the second size when the spacer is in the second configuration being substantially equal to the second size when the spacer is in the first configuration.

22. The apparatus ofclaim 21, wherein the first spacer member and the second spacer member collectively define an opening when the spacer is in the second configuration.

23. The apparatus ofclaim 21, wherein the first surface of the first actuator member is matingly and movably coupled to the first surface of the first spacer member such that the first actuator member remains in sliding contact with the first spacer member over a range of motion.

24. The apparatus ofclaim 21, wherein:

the first surface of the first spacer member defines a groove having a trapezoidal cross-sectional shape; and

the first surface of the first actuator member includes a protrusion having a trapezoidal cross-sectional shape, the protrusion configured to be matingly received within the groove.

25. The apparatus ofclaim 21, wherein the first spacer member is configured to translate relative to second spacer member in a direction substantially normal to the longitudinal axis when the spacer is moved from the first configuration to the second configuration.

26. The apparatus ofclaim 21, wherein:

the first surface of the first spacer member defines a groove, the second surface of the first spacer member defines a groove;

the first surface of the second spacer member defines a groove, the second surface of the second spacer member defines a groove;

the first surface of the first actuator member has a protrusion configured to be matingly received within the groove of the first surface of the first spacer member, the groove the first surface of the first spacer member and the protrusion of the first surface of the first actuator member collectively configured to maintain the first actuator member in sliding contact with the first spacer member;

the first surface of the second actuator member has a protrusion configured to be matingly received within the groove of the second surface of the first spacer member, the groove of the second surface of the first spacer member and the protrusion of the first surface of the second actuator member collectively configured to maintain the second actuator member in sliding contact with the first spacer member;

the second surface of the first actuator member has a protrusion configured to be matingly received within the groove of the first surface of the second spacer member, the groove of the first surface of the second spacer member and the protrusion of the second surface of the first actuator member collectively configured to maintain the first actuator member in sliding contact with the second spacer member; and

the second surface of the second actuator member has a protrusion configured to be matingly received within the groove of the second surface of the second spacer member, the groove of the second surface of the second spacer member and the protrusion of the second surface of the second actuator member collectively configured to maintain the second actuator member in sliding contact with the second spacer member.

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