Source: http://www.google.com/patents/US8100977?dq=1886562
Timestamp: 2014-12-29 02:37:25
Document Index: 666184171

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'application No. 2010200382', 'Application No. 200680018453', 'Application No. 200680034261', 'Application No. 2008']

Patent US8100977 - Interlocked modular disc nucleus prosthesis - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA method and apparatus for repairing a damaged intervertebral disc nucleus in a minimally invasive manner utilizes a modular disc prosthesis. The modular disc prosthesis preferably comprises at least three modular segments. In one embodiment, each modular segment includes an inner core and an outer shell....http://www.google.com/patents/US8100977?utm_source=gb-gplus-sharePatent US8100977 - Interlocked modular disc nucleus prosthesisAdvanced Patent SearchPublication numberUS8100977 B2Publication typeGrantApplication numberUS 11/900,205Publication dateJan 24, 2012Filing dateSep 10, 2007Priority dateMar 9, 2005Also published asUS20080140206, WO2006127848A2, WO2006127848A3Publication number11900205, 900205, US 8100977 B2, US 8100977B2, US-B2-8100977, US8100977 B2, US8100977B2InventorsJeffrey C. FeltOriginal AssigneeVertebral Technologies, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (107), Non-Patent Citations (92), Classifications (25), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetInterlocked modular disc nucleus prosthesisUS 8100977 B2Abstract A method and apparatus for repairing a damaged intervertebral disc nucleus in a minimally invasive manner utilizes a modular disc prosthesis. The modular disc prosthesis preferably comprises at least three modular segments. In one embodiment, each modular segment includes an inner core and an outer shell. The modular segments are selectively interlockable in situ with each other. The modular segments form an implanted unitary device that closely mimics the geometry of the disc nucleus cavity.
1. A modular disc prosthesis that is adapted to be implanted in an evacuated disc nucleus space from a generally posterior approach, the prosthesis comprising:
at least three modular segments, each modular segment having a width defined by opposing sides, a proximal end, and a distal end, the modular segments being selectively interlockable with each other such that the prosthesis has:
an extended configuration in which the proximal end of one side of an outer modular segment is operably positioned proximate the distal end of one of the sides of an intermediate modular segment and the distal end of one side of another outer modular segment is operably positioned proximate the proximal end of another of the sides of an intermediate modular segment, and
an implanted configuration in which the modular segments are positioned within the evacuated disc nucleus space in a generally side by side relation with the proximal ends of each modular segment adjacent one another and the distal ends of each modular segment adjacent one another so as to define a unitary body having a generally continuous periphery in which an overall width of the modular segments generally corresponds to a width of the evacuated disc nucleus space,
wherein each modular segment comprises an outer shell of a layer of solid polymer material having a depth extending outward from an inner core, the inner core of each modular segment having a durometer hardness higher than a durometer hardness of the outer shell of each modular segment, the inner core of each modular segment including structure on at least one side that selectively interlocks with corresponding structure on at least one side of an adjacent modular segment, the outer shell substantially surrounding the inner core of each modular segment except for the at least one side having the structure that selectively interlocks adjacent modular segment.
2. The modular disc prosthesis of claim 1, further comprising at least two intermediate modular segments wherein the proximal end of one of the sides of one of the intermediate modular segments is operably positioned proximate the distal end of one of the sides of another of the intermediate modular segments.
3. The modular disc prosthesis of claim 1, wherein the inner core is comprised of a hygroscopic material and the outer shell is comprised of a polymer.
4. The modular disc prosthesis of claim 1, wherein the polymers of the inner core and the outer shell of each modular segment are copolymerized.
5. The modular disc prosthesis of claim 1, wherein the structures that selectively interlock adjacent modular segments are similar for all modular segments.
6. The modular disc prosthesis of claim 1, wherein the structures that selectively interlock adjacent modular segments comprise a ratchet on one side and a corresponding pawl on another side.
7. The modular disc prosthesis of claim 1, wherein at least a layer of the outer shell further comprises at least one medicant operably carried by the outer shell to be eluted after the prosthesis is implanted.
8. The modular disc prosthesis of claim 1, wherein the widths of the modular segments are substantially similar and define a width of the prosthesis in the extended configuration that determines a minimum width of an opening for insertion of the prosthesis into the evacuated disc nucleus space.
9. The modular disc prosthesis of claim 1, further comprising a tether threaded through an aperture in at least one of the modular segments to aid in aligning the modular disc prosthesis during implantation.
PRIORITY APPLICATIONS This application continuation of application Ser. No. 11/372,357 filed Mar. 9, 2006, now U.S. Pat. No. 7,267,690 which claims the benefit of U.S. Provisional Patent Application No. 60/660,107, entitled �MODULAR DISC PROSTHESIS,� filed Mar. 9, 2005, U.S. Provisional Patent Application No. 60/685,332, entitled �SPINE DISC NUCLEUS II,� filed May 24, 2005, and U.S. Provisional Patent Application No. 60/700,459, entitled �SPINE POLYMER PATENT,� filed Jul. 19, 2005, the disclosures of which are hereby incorporated by reference.
RELATED APPLICATIONS The present invention is also related to the co-pending application filed concurrently herewith entitled, �RAIL-BASED MODULAR DISC NUCLEUS PROSTHESIS�, a copy of which is attached hereto and the disclosure of which is hereby incorporated by reference.
FIELD OF THE INVENTION The present invention relates generally to an implantable prosthesis for repairing damaged intervertebral discs. More particularly, the present invention relates to an interlocked modular disc nucleus prosthesis of predetermined size and shape.
BACKGROUND OF THE INVENTION The spinal motion segment consists of a unit of spinal anatomy bounded by two vertebral bodies, including the two vertebral bodies, the interposed intervertebral disc, as well as the attached ligaments, muscles, and the facet joints. The disc consists of the end plates at the top and bottom of the vertebral bones, the soft inner core, called the nucleus and the annulus fibrosus running circumferentially around the nucleus. In normal discs, the nucleus cushions applied loads, thus protecting the other elements of the spinal motion segment. A normal disc responds to compression forces by bulging outward against the vertebral end plates and the annulus fibrosus. The annulus consists of collagen fibers and a smaller amount of elastic fibers, both of which are effective in resisting tension forces. However, the annulus on its own is not very effective in withstanding compression and shear forces.
As people age the intervertebral discs often degenerate naturally. Degeneration of the intervertebral discs may also occur in people as a result of degenerative disc disease. Degenerative disc disease of the spine is one of the most common conditions causing pain and disability in our population. When a disc degenerates, the nucleus dehydrates. When a nucleus dehydrates, its ability to act as a cushion is reduced. Because the dehydrated nucleus is no longer able to bear loads, the loads are transferred to the annulus and to the facet joints. The annulus and facet joints are not capable of withstanding their increased share of the applied compression and torsional loads, and as such, they gradually deteriorate. As the annulus and facet joints deteriorate, many other effects ensue, including the narrowing of the interspace, bony spur formation, fragmentation of the annulus, fracture and deterioration of the cartilaginous end plates, and deterioration of the cartilage of the facet joints. The annulus and facet joints lose their structural stability and subtle but pathologic motions occur between the spinal bones.
As the annulus loses stability it tends to bulge outward and may develop a tear allowing nucleus material to extrude. Breakdown products of the disc, including macroscopic debris, microscopic particles, and noxious biochemical substances build up. The particles and debris may produce sciatica and the noxious biochemical substances can irritate sensitive nerve endings in and around the disc and produce low back pain. Affected individuals experience muscle spasms, reduced flexibility of the low back, and pain when ordinary movements of the trunk are attempted.
Degeneration of a disc is irreversible. In some cases, the body will eventually stiffen the joints of the motion segment, effectively re-stabilizing the discs. Even in the cases where re-stabilization occurs, the process can take many years and patients often continue to experience disabling pain. Extended painful episodes of longer than three months often leads patients to seek a surgical solution for their pain.
Several methods have been devised to attempt to stabilize the spinal motion segment. Some of these methods include: heating the annular region to destroy nerve endings and strengthen the annulus; applying rigid or semi-rigid support members on the sides of the motion segment or within the disc space; removing and replacing the entire disc with a generally rigid plastic, articulating artificial device; removing and replacing the nucleus; and spinal fusion involving permanently fusing the vertebrae adjacent the affected disc.
Until recently, spinal fusion has generally been regarded as the most effective surgical treatment to alleviate back pain due to degeneration of a disc. While this treatment is often effective at relieving back pain, all discal motion is lost in the fused spinal motion segment. The loss of motion in the affected spinal segment necessarily limits the overall spinal mobility of the patient. Ultimately, the spinal fusion places greater stress on the discs adjacent the fused segment as these segments attempt to compensate for lack of motion in the fused segment, often leading to early degeneration of these adjacent spinal segments.
Current developments are focusing on treatments that can preserve some or all of the motion of the affected spinal segment. One of these methods to stabilize the spinal motion segment without the disadvantages of spinal fusion is total disc replacement. Total disc replacement is a highly invasive and technically demanding procedure which accesses the disc from an anterior or frontal approach and includes dividing the anterior longitudinal ligament, removing the cartilaginous end plates between the vertebral bone and the disc, large portions of the outer annulus and the complete inner nucleus. Then an artificial total disc prosthesis is carefully placed in the evacuated disc space. Many of the artificial total disc replacements currently available consist of a generally rigid plastic such as ultra high molecular weight polyethylene (�UHMWPE�) as the nucleus that is interposed between two metal plates that are anchored or attached to the vertebral endplates. A summary of the history of early development and designs of artificial discs is set forth in Ray, �The Artificial Disc: Introduction, History and Socioeconomics,� Chpt. 21, Clinical Efficacy and Outcome in the Diagnosis of Low Back Pain, pgs. 205-225, Raven Press (1992). Examples of these layered total disc replacement devices are shown, for example, in U.S. Pat. Nos. 4,911,718, 5,458,643, 5,545,229 and 6,533,818.
These types of artificial total discs have several disadvantages. First, because the artificial disc replacements are relatively large, they require relatively large surgical exposures to accommodate their insertion. The larger the surgical exposure, the higher the chance of infection, hemorrhage or even morbidity. Also, in order to implant the prosthetic, a large portion of the annulus must be removed. Removing a large portion of the annulus reduces the stability of the motion segment, at least until healing occurs around the artificial disc. Further, because the devices are constructed from rigid materials, they can cause serious damage if they were to displace from the disc space and contact local nerve or vascular tissues. Another disadvantage is that rigid artificial disc replacements do not reproduce natural disc mechanics.
An alternative to total disc replacement is nucleus replacement. Like an artificial disc prosthesis, these nucleus replacements are also inert, non-rigid, non-biological replacements. The procedure for implanting a nucleus replacement is less invasive than the procedure for a total disc replacement and generally includes the removal of only the nucleus and replacement of the nucleus with a prosthesis that may be elastically compressible and provide cushioning that mimics a natural disc nucleus. Examples of implants used for nucleus replacement include: U.S. Pat. Nos. 4,772,287, 4,904,260, 5,192,326, 5,919,236 and 6,726,721.
Nucleus replacements are intended to more closely mimic natural disc mechanics. To that end, some nucleus replacements utilize hydrogels because of their water imbibing properties that enable these replacements to expand in situ to permit a more complete filling of the evacuated nucleus cavity. However, there is usually a trade-off in that the more expansion the hydrogel achieves, the less structural support the end product can provide. As a result, many hydrogel nucleus disc replacements have generally adopted the use of some form of a jacket or fabric to constrain the hydrogel material. For example, the implant described in U.S. Pat. Nos. 4,772,287 and 4,904,260 consists of a block of hydrogel encased in a plastic fabric casing. The implant described in U.S. Pat. No. 5,192,326 consists of hydrogel beads enclosed by a fabric shell. Without the jacket or other form of constraint, the hydrogel is susceptible to displacement because of the slippery nature of the hydrogel. Unfortunately, the jacket or fabric shell will be subject to long term abrasive wear issues that could result in failure of the jacket or shell's ability to constrain the hydrogel and thus the hydrogel may be subject to displacement.
Another approach to nucleus replacement involves implantation of a balloon or other container into the nucleus, which is then filled with a biocompatible material that hardens in situ. Examples of this in situ approach to nucleus replacement include U.S. Pat. Nos. 6,443,988 and 7,001,431. One of the problems with this approach is that the chemical hardening process is exothermic and can generate significant amounts of heat that may cause tissue damage. In addition, there is a possibility that the balloon may rupture during expansion, causing leakage of material into the disc cavity and surrounding tissues, which may cause undesirable complications.
Another technique for nucleus replacement involves implanting a multiplicity of individual support members, such as beads, one at a time in the evacuated disc nucleus cavity until the cavity is full. Examples of this approach include U.S. Pat. Nos. 5,702,454 and 5,755,797. Because each of the individual support members or beads is relatively small, there is a possibility that one or more of the individual support members or beads may extrude out of the evacuated disc nucleus cavity. From a mechanical perspective, this technique is limited in the ability to produce consistent and reproducible results because the location and interaction of the multiplicity of beads or support members is not controlled and the beads or support members can shift during and after implantation.
Accordingly, there is a need for a nucleus prosthesis that may be inserted using a minimally invasive procedure and that mimics the characteristics of a natural disc.
SUMMARY OF THE INVENTION The present invention provides a method and apparatus for repairing a damaged intervertebral disc nucleus in a minimally invasive manner utilizing a modular disc nucleus prosthesis. The modular disc prosthesis preferably comprises at least three modular segments. This configuration allows the prosthesis to be adapted for implantation through various surgical approaches, although the preferred method is the posterolateral (�posterior�) approach where the disc is accessed through the patient's back. In one embodiment, each modular segment includes an inner core and an outer shell. The modular segments are selectively interlockable in situ with each other. The modular segments form an implanted unitary device that closely mimics the geometry of the disc nucleus cavity.
In one embodiment, a modular disc nucleus prosthesis that is adapted to be implanted in an evacuated disc nucleus space includes at least three modular segments each having a width defined by opposing sides, a proximal end, and a distal end. The modular segments are selectively interlockable with each other such that the prosthesis has an extended configuration and an implanted configuration. In the extended configuration the proximal end of one side of an outer modular segment is operably positioned proximate the distal end of one of the sides of an intermediate modular segment and the distal end of one side of another outer modular segment is operably positioned proximate the proximal end of another of the sides of an intermediate modular segment. In the implanted configuration the modular segments are positioned within the evacuated nucleus disc space in a generally side by side relation with the proximal ends of each modular segment adjacent one another and the distal ends of each modular segment adjacent one another so as to define a unitary body having a generally continuous periphery in which an overall width of the modular segments generally corresponds to a width of the evacuated disc nucleus cavity.
In one embodiment, each modular segment comprises an inner core and an outer shell. Outer shells of modular segments are preferably comprised of a polymeric material. In one embodiment, the inner cores of the modular segments are comprised of polyvinyl alcohol (PVA), which can be insert molded into the polymer outer shell. This softens the compression modulus of the modular disc prosthesis, allowing the device to more closely mimic the properties of a natural disc nucleus. In addition, PVA will cause the prosthesis to swell a small amount once inside the body, allowing the device to more fully fill the disc nucleus space.
In another embodiment, each modular segment comprises an inner core and an outer shell. The inner core includes structure that allows adjacent modular segments to mate with one another. The outer shell substantially surrounds the inner core, except for the sides having the mating structure. In one embodiment, the inner core of each modular segment and the outer shell of each modular segment are made of polymers of different durometers. In this embodiment, the inner core of each modular segment preferably has a compressive modulus from about 70-100 MPa and the outer shell of each modular segment has a compressive modulus from about 6-20 MPa. The use of a harder inner core and softer outer shell as part of an integrated unitary implanted device permits the modular prosthesis of the present invention to more closely mimic the stress response of a biological disc nucleus while simultaneously permitting effective operation of the slidable relationship between adjacent modular segments.
Another aspect of the present invention provides a method for implanting a modular disc nucleus prosthesis. The method is minimally invasive because the modular disc prosthesis is implanted incrementally, so the device can be implanted through an annulotomy much smaller than the size of the implanted configuration of the device. To implant modular disc prosthesis, the first modular segment is introduced into the patient's disc space and is placed partway into the disc nucleus space. The second modular segment is then attached to the first modular segment. When the first modular segment is mostly inserted into the disc nucleus space the second modular segment is slid up partway into the disc space and the third modular segment is attached to the second modular segment. The first modular segment is completely inserted at this point. The second modular segment is then extended into position along side of the first modular segment and is locked into place in the disc nucleus space. Finally, the third modular segment is inserted completely into the disc nucleus space and is locked in place with the other modular segments. The final implanted side by side configuration of modular segments of the modular disc prosthesis is sized and shaped to mimic the natural disc nucleus. It will be recognized that there may be more than three modular segments and that the modular segments may be attached to one another before or during the operation to form the expanded configuration as described.
Another aspect of the present invention provides an insertion tool for inserting the modular segments of modular disc nucleus prosthesis and interlocking the modular segments in situ. Insertion tool has a distal end having a mechanism that selectively engages and releases one or more modular segments and a proximal end having a means to activate the engagement and release mechanism. The distal end of insertion tool may also include a means to align a modular segment being inserted with one already positioned in the disc space.
FIG. 1 is a perspective view of a modular disc prosthesis according to the preferred embodiment of the present invention.
FIG. 2 is a top view of a modular disc prosthesis according to the preferred embodiment of the present invention.
FIG. 3A is a perspective view of a first modular segment according to the preferred embodiment of the present invention.
FIG. 3B is a top view of a first modular segment according to the preferred embodiment of the present invention.
FIG. 4 is a perspective view of a second modular segment according to the preferred embodiment of the present invention.
FIG. 5 is a perspective view of a third modular segment according to the preferred embodiment of the present invention.
FIG. 6 is a perspective view of a fourth modular segment according to the preferred embodiment of the present invention.
FIG. 7 is a partial view of a modular disc prosthesis according to the preferred embodiment of the present invention.
FIG. 8 is a top view of a modular disc prosthesis according to the preferred embodiment of the present invention.
FIG. 9 is a perspective view of a modular disc prosthesis according to an alternate embodiment of the present invention.
FIG. 10 is a perspective view of a modular disc prosthesis according to an alternate embodiment of the present invention.
DETAILED DESCRIPTION OF THE DRAWINGS Referring to FIGS. 1 and 2, there can be seen a modular disc prosthesis 100 according to the preferred embodiment of the present invention. In this embodiment, modular disc prosthesis 100 comprises first 102, second 104, third 106, and fourth 108 interlocking modular segments. One of skill in the art will recognize that in alternate embodiments the preferred embodiment can be easily modified to comprise greater or fewer modular segments, as long as there are at least three modular segments for a posterolateral approach and at least two modular segments for an anteriolateral approach.
Referring now to FIGS. 3A-3B there can be seen first modular segment 102 of modular disc prosthesis 100 according to the preferred embodiment of the present invention. First modular segment 102 is preferably comprised of an outer shell 102 a and an inner core 102 b. Inner core 102 b further includes a locking slide 110 for interlocking with an adjacent modular segment.
Second modular segment 104 according to the preferred embodiment of the present invention is depicted in FIG. 4. Second modular segment 104 is comprised of an outer shell 104 a and an inner core 104 b. Inner core 104 b further includes first 112 and second 114 slots into which locking slides of adjacent modular segments are inserted.
Referring to FIG. 5, third modular segment 106 of the preferred embodiment of modular disc prosthesis 100 is shown. Third modular segment 106 is comprised of an outer shell 106 a and an inner core 106 b. Inner core 106 b further includes first 116 and second 118 locking slides for insertion into slots in adjacent modular segments.
The fourth modular segment 108 according to the preferred embodiment of the present invention is shown in FIG. 6. Fourth modular segment 108 is comprised of an outer shell 108 a and an inner core 108 b. Inner core 108 b further includes a slot 120 for connecting to an adjacent modular segment.
As can be seen from the above description and the drawings, each modular segment 102, 104, 106, 108 is unique. The two outermost modular segments 102 and 108 have interlocking structure defined on only an inner facing side, whereas the intermediate modular segments 104 and 106 have interlocking structure defined on both side of the width of each module. The unique configuration of each module assures that the order of insertion of the modular segments cannot be mixed up and the proper number of modular segments is used. The four part design comes packaged sterile and ready for assembly at the surgical site. In alternate embodiments, modular segments may be of a uniform design (for example, a slot on one side and a locking slide on the other) in order to allow for the surgeon to freely add or subtract from the total number of modular segments or to select an intermediate modular segment of differing widths to change the size of modular disc prosthesis to better accommodate the disc nucleus space in a particular procedure.
As can be seen in FIG. 7, modular segments 102, 104, 106, 108 are capable of interlocking with one another by inserting locking slides 110, 116, 118 into slots 112, 114, 120. In the preferred embodiment, locking slides 110, 116, 118 and slots 112, 114, 120 have a tongue-in-groove design. Interlocking may be accomplished with ridges, dovetail, ratchet and pawl or any other suitable mechanical interface method. Interlocking may also be complimented by or entirely accomplished by material interface such as by forming the interlocking interface of materials that are hygroscopic and swell in situ or by forming a chemical bond across the interface.
Interlocking may be strengthened by providing locking elements, such as barbs, molded along the locking slides with corresponding locking ridges molded on the edges of slots. In an embodiment of the present invention, the disc nucleus device includes at least one bidirectional locking element to prevent forward and/or backward motion of the components. In another embodiment, the disc nucleus prosthesis may include at least two unidirectional locking elements. Wherein at least one of the locking elements prevents forward movement of the components and at least one of the other unidirectional locking elements prevents backward movement of the components. A ratchet release tool or other similar tool may be provided in case separation of modular segments is desired once they are locked together. One of skill in the art will recognize that modular segments can interlock through a variety of other means. In addition, modular segments may also be provided with an end block to ensure flush alignment between modular segments.
In the preferred embodiment, modular disc prosthesis 100 is molded from elastomeric biomaterials, preferably polyurethane. Inner cores 102 b, 104 b, 106 b, 108 b are made from a hard durometer polyurethane, such as a polyurethane with a Shore D hardness of about 45 or above and compressive modulus in the range of about 70 to 100 MPa. Outer shells 102 a, 104 a, 106 a, 108 a are made from a softer durometer polyurethane, such as a polyurethane with a Shore A hardness ranging from about 40 to 80 and a compressive modulus in the range of about 6 to 20 MPa.
In the preferred embodiment, the two different durometer polyurethanes may be co-polymerized to create a chemical bond between the two portions of each modular segment 102, 104, 106, 108. In alternate embodiments, other polymers such as PEEK, polyethylene, silicones, acrylates, nylon, polyacetyls, and other similar biocompatible polymers may be used for the inner cores or the outer shells.
In an alternative embodiment, inner core 102 b, 104 b, 106 b, 108 b of modular segments 102, 104, 106, 108 is comprised of polyvinyl alcohol (PVA). PVA may be insert molded into the polyurethane shell. The PVA takes on much more water than the polyurethane, which serves two advantages. First, this softens the compression modulus of modular disc prosthesis 100, allowing the device to more closely mimic the properties of a natural disc nucleus. Second, it will swell the prosthesis 100 a small amount once inside the body, allowing the device to more fully fill the disc nucleus space. Those of skill in the art will understand how to select a PVA of appropriate hydrophilic characteristic to adjust the resultant compressive modulus of the prosthesis to a physiologically acceptable value. In alternate embodiments, the inner core may be comprised of any other suitable hygroscopic material.
In the preferred embodiment, the modular disc nucleus prosthesis is deformable in response to normal physiological forces of 30 to 300 pounds. Because of this deformability, the prosthesis produces a physiologically appropriate amount of loading on the end plates of the intervertebral disc. As a result, the end plates will not excessively deform over time and ultimately conform to the contours of the implant as is the case with many more rigid disc nucleus replacement implants.
The modular disc nucleus prosthesis may be introduced through an access tube that is inserted partially into the disc nucleus space. Access tube is at least 3 inches long and preferably about 6 inches long. It should be noted that although the insertion of modular disc prosthesis is described in relation to a preferred four-segment embodiment, embodiments having any other number of segment s would be inserted in a similar fashion.
An insertion tool may be used to aid in the insertion and positioning of the modular prosthesis. Such a tool has a distal end that selectively engages and releases the modular segments and a proximal end containing a means to activate the engagement and release mechanism. The engagement method of the insertion tool may include a full or partial sleeve that provides an interference fit with the outer surface of the modular segments, a rod possessing a tip that can be expanded to interlock in a corresponding cavity within each modular segment, two or more rods with shaped or angled tips that can be inserted and opposed into corresponding cavities within each modular segment, or other similar means apparent to one skilled in the art. The distal end of the insertion tool may also possess a wire, rod, rail, or other means to align a modular segment being inserted with one already positioned at least partly within the disc space. The insertion tool may be made out of any combination of plastics, metals, ceramics, or the like.
Upon inserting the access tube into the disc nucleus space, first modular segment 102, as shown in FIGS. 1 and 2, is inserted part way into the disc space using a first insertion tool. The distal end of the second modular segment 104 is then attached to the proximal end of the first modular segment 102 by sliding slot 112 onto locking slide 110 with a second insertion tool. When first modular segment 102 is preferably approximately 80% inserted into the disc nucleus space, the second modular segment 104 is transposed along the locking slide 110 of first modular segment 102 partway into the disc nucleus space and the distal end of the third modular segment 106 is attached to the proximal end of the second modular segment 104 by sliding locking slide 116 into slot 114 with a third insertion tool. First modular segment 102 is completely inserted at this point and is released from the first insertion tool. Second modular segment 104 is then extended into position along side of first modular segment 102, is locked into place in the disc nucleus space and is released from second insertion tool. Third modular segment 106 is now partway in the disc nucleus space and the distal end of fourth modular segment 108 is attached to the proximal end of third modular segment 106 by sliding slot 120 onto locking slide 118 with a fourth insertion tool. Third modular segment 106 is then completely inserted and locked into place and is released from third insertion tool. Finally, fourth modular segment 108 is inserted completely into the disc nucleus space, locked in place with the other modular segments, and released from fourth insertion tool. The final, locked configuration of modular disc prosthesis 100 of this embodiment is shown in FIG. 8.
In another embodiment, first modular segment is engaged by a first insertion tool and fully inserted into the nucleus cavity. Second modular segment is then attached to first modular segment using a second insertion tool and is fully inserted into the nucleus cavity. Subsequent modular segments are then attached in the same manner until the modular prosthesis is fully assembled. Alternatively, the insertion tool used with any of the embodiments of the present invention may be designed to engage two or more modular segments simultaneously to avoid requiring multiple insertion tools to perform the implantation procedure.
Alternatively, modular disc prosthesis may be implanted using an anterior lateral approach. An anterior lateral approach allows for a larger insertion opening to be used while still being minimally invasive. In this approach, the disc is accessed from the patient's side through the psoas muscle, which avoids major nerve and vascular tissues, and may be used in the presence of medical conditions mitigating against the posterior approach. This approach is essentially oriented 90� from the posterior approach.
The prosthesis consists of preformed components that are under direct surgeon control until the device is completely formed, thus, there is little chance of dislocation of the components as the components are inserted. The ability to control the components during insertion is an advantage over devices that employ individual support members, such as beads, which once inserted are beyond the surgeon's control and may move about in the evacuated disc space. Because the components of the present invention remain under the surgeon's direct control, the surgeon is able to place the components more precisely in the evacuated disc space with less chance of the components moving into an undesirable position during insertion of the device.
Further, the ability to predetermine the size of the modular disc prosthesis also allows for the nucleus cavity to be more completely filled and provides a greater degree of control over the uniformity of the stress response of the implant as compared to other kinds of minimally invasive implants. Because the stress response of the implant may be controlled, even with an incompetent posterior wall, the prosthesis should remain stable. The ability to tailor the size of the prosthesis and completely fill the nucleus cavity also prohibits the prosthesis from dislodging out of the nucleus cavity after the device is completely implanted as can happen with some hydrogel block implants.
Referring now to FIGS. 9 and 10 there can be seen an alternate embodiment of modular disc prosthesis 200. Modular disc prosthesis 200 is a three piece implant with tethers 216, 218 to help align the device. Modular disc prosthesis 200 comprises a first modular segment 202 with a slot 208 formed therein, a second modular segment 204 with first 210 and second 212 locking slides, and a third modular segment 206 having a slot 214. Modular disc prosthesis 200 further includes tethers 216, 218 that are threaded through holes 220, 222 in first modular segment 202 and third modular segment 206. One of skill in the art will recognize that the number and location of tethers 216, 218 may vary and that tethers may be used with modular disc prosthesis having different numbers of modular segments.
In an alternate embodiment, the outer shell of the modular disc nucleus prosthesis may be modified to provide for elution of medicants. Such medicants may include analgesics, antibiotics, antineoplastics or bioosteologics such as bone growth agents. While motion preservation is generally a principle goal in nucleus replacement, in certain indications it may be desirable to promote some bony fusion. Such indications may include nuclear replacements in the cervical spine.
The solid polymer outer shell of the modular disc nucleus prosthesis may provide for better and more controllable elution rates than some hydrogel materials. In an alternate embodiment, the modular disc nucleus prosthesis may include different elution rates for each polymer material. This would allow for varying elution rates for different medicants.
Various modifications to the disclosed apparatuses and methods may be apparent to one of skill in the art upon reading this disclosure. The above is not contemplated to limit the scope of the present invention, which is limited only by the claims below.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS3030951Apr 10, 1959Apr 24, 1962Michael P MandarinoMethods and materials for orthopedic surgeryUS3728742Jun 18, 1971Apr 24, 1973HowmedicaKnee or elbow prosthesisUS3815599Mar 2, 1973Jun 11, 1974W DeyerleFemoral shaft surgical rasp for use in hip prosthesis surgeryUS3848601Jun 14, 1972Nov 19, 1974G MaMethod for interbody fusion of the spineUS3867728Apr 5, 1973Feb 25, 1975Cutter LabProsthesis for spinal repairUS3867729Aug 17, 1973Feb 25, 1975Mere Ind IncIncineratorUS4081866Feb 2, 1977Apr 4, 1978Howmedica, Inc.Total anatomical knee prosthesisUS4203444Nov 7, 1977May 20, 1980Dyonics, Inc.Surgical instrument suitable for closed surgery such as of the kneeUS4349921Jun 16, 1980Sep 21, 1982Kuntz J DavidIntervertebral disc prosthesisUS4456745Jul 11, 1983Jun 26, 1984Ethyl CorporationPolyol formed by catalytic decyclization of cyclic carbonateUS4463141Jan 24, 1983Jul 31, 1984E. I. Du Pont De Nemours And CompanyPolyether carbonate diols and polyurethanes prepared therefromUS4476293Jan 24, 1983Oct 9, 1984E. I. Du Pont De Nemours And CompanyPolymeric carbonate diols of copolyether glycols and polyurethanes prepared therefromUS4477604Sep 20, 1982Oct 16, 1984Oechsle Iii Sixtus JContaining reinforcing graft copolymers polyols and polyethersiloxane stabilizerUS4502161Aug 19, 1983Mar 5, 1985Wall W HProsthetic meniscus for the repair of jointsUS4647643Nov 8, 1985Mar 3, 1987Becton, Dickinson And CompanySoft non-blocking polyurethanesUS4651736Feb 1, 1986Mar 24, 1987Bruce SandersMethods for temporomandibular joint small incision surgeryUS4711639Sep 10, 1985Dec 8, 1987S+G Implants GmbhAnchorage for tibia platesUS4722948Feb 13, 1986Feb 2, 1988Dynatech CorporationBone replacement and repair putty material from unsaturated polyester resin and vinyl pyrrolidoneUS4743256Jan 22, 1987May 10, 1988Brantigan John WSurgical prosthetic implant facilitating vertebral interbody fusion and methodUS4743632Feb 25, 1987May 10, 1988Pfizer Hospital Products Group, Inc.Polyetherurethane urea polymers as space filling tissue adhesivesUS4772287Aug 20, 1987Sep 20, 1988Cedar Surgical, Inc.Prosthetic disc and method of implantingUS4808691May 11, 1988Feb 28, 1989Bayer AktiengesellschaftPolyether-polycarbonate diols and processes for their production and useUS4834757Mar 28, 1988May 30, 1989Brantigan John WProsthetic implantUS4863476Aug 28, 1987Sep 5, 1989Shepperd John A NSpinal implantUS4873308Sep 30, 1988Oct 10, 1989Medtronic, Inc.Formation of soft prepolymer, reaction with diol and diisocyanate to form hard segment; both alcohol and ether freeUS4880610Apr 20, 1988Nov 14, 1989Norian CorporationNeutralization, crystallizationUS4904260Jul 25, 1988Feb 27, 1990Cedar Surgical, Inc.Prosthetic disc containing therapeutic materialUS4911718Jun 10, 1988Mar 27, 1990University Of Medicine & Dentistry Of N.J.Functional and biocompatible intervertebral disc spacerUS4969888Feb 9, 1989Nov 13, 1990Arie ScholtenSurgical protocol for fixation of osteoporotic bone using inflatable deviceUS5007940Jun 9, 1989Apr 16, 1991American Medical Systems, Inc.Injectable polymeric bodiesUS5047055Dec 21, 1990Sep 10, 1991Pfizer Hospital Products Group, Inc.Prosthetics; biocompatibility; compressive strengthUS5067964Dec 13, 1989Nov 26, 1991Stryker CorporationArticular surface repairUS5082803Sep 21, 1990Jan 21, 1992Asahi Kogaku Kogyo Kabushiki KaishaCeramics, pullulanUS5108404Aug 15, 1990Apr 28, 1992Arie ScholtenSurgical protocol for fixation of bone using inflatable deviceUS5109077Feb 13, 1990Apr 28, 1992Azko NvBiocompatible polyurethaneUS5143942Oct 28, 1991Sep 1, 1992Ethyl CorporationPolyurethanesUS5166115Feb 3, 1992Nov 24, 1992Brown William RAlkylthio-substituted toluenediamine monomers; polyureas; low density, tear and tensile strength, flexibilityUS5192326Sep 9, 1991Mar 9, 1993Pfizer Hospital Products Group, Inc.Prosthetic nucleus for implanting disks, hydrogel beads and semipermeable coverUS5192327Mar 22, 1991Mar 9, 1993Brantigan John WSurgical prosthetic implant for vertebraeUS5254662May 18, 1992Oct 19, 1993Polymedia Industries, Inc.Biostable polyurethane productsUS5263987May 28, 1991Nov 23, 1993Shah Mrugesh KMethod and apparatus for arthroscopically replacing a bone jointUS5278201Apr 24, 1990Jan 11, 1994Atrix Laboratories, Inc.Polymers biodegradable by enzyme hydrolysisUS5344458Aug 6, 1992Sep 6, 1994Bonutti Peter MArthroplasty componentUS5344459Mar 17, 1993Sep 6, 1994Swartz Stephen JArthroscopically implantable prosthesisUS5397364Oct 12, 1993Mar 14, 1995Danek Medical, Inc.Anterior interbody fusion deviceUS5458643Feb 1, 1994Oct 17, 1995Kyocera CorporationArtificial intervertebral discUS5509934Dec 7, 1994Apr 23, 1996Osteonics Corp.Prosthetic knee tibial component constructed of synthetic polymeric materialUS5514180Jan 14, 1994May 7, 1996Heggeness; Michael H.Prosthetic intervertebral devicesUS5522899Jun 7, 1995Jun 4, 1996Sofamor Danek Properties, Inc.Artificial spinal fusion implantsUS5525418Dec 23, 1994Jun 11, 1996Fuji Photo Film Co., Ltd.Magnetic recording medium having a magnetic layer containing ferromagnetic powder and a polyurethane resin obtained from a polyolefin polyol or a polybutadiene polyolUS5545229Jul 28, 1993Aug 13, 1996University Of Medicine And Dentistry Of NjFunctional and biocompatible intervertebral disc spacer containing elastomeric material of varying hardnessUS5549683Apr 28, 1994Aug 27, 1996Bonutti; Peter M.Anthroplasty componentUS5554191Jan 23, 1995Sep 10, 1996BiomatIntersomatic vertebral cageUS5556429May 6, 1994Sep 17, 1996Advanced Bio Surfaces, Inc.BiocompatibilityUS5562736Oct 17, 1994Oct 8, 1996Raymedica, Inc.Method for surgical implantation of a prosthetic spinal disc nucleusUS5609635Jun 7, 1995Mar 11, 1997Michelson; Gary K.Lordotic interbody spinal fusion implantsUS5624463Apr 25, 1994Apr 29, 1997Regen Biologics, Inc.Prosthetic articular cartilageUS5674294Sep 14, 1994Oct 7, 1997Commissariat A L'energie AtomiqueIntervertebral disk prosthesisUS5702453May 13, 1996Dec 30, 1997Sofamor Danek GroupAdjustable vertebral body replacementUS5702454May 29, 1996Dec 30, 1997Sulzer Orthopadie AgProcess for implanting an invertebral prosthesisUS5725531Dec 27, 1995Mar 10, 1998Shapiro; Jules S.For removing cartilage from the end of a boneUS5755797Oct 2, 1996May 26, 1998Sulzer Medizinaltechnik AgIntervertebral prosthesis and a process for implanting such a prosthesisUS5772661Feb 27, 1995Jun 30, 1998Michelson; Gary KarlinMethods and instrumentation for the surgical correction of human thoracic and lumbar spinal disease from the antero-lateral aspect of the spineUS5776199May 2, 1997Jul 7, 1998Sofamor Danek PropertiesArtificial spinal fusion implantsUS5795353Nov 2, 1996Aug 18, 1998Advanced Bio Surfaces, Inc.Joint resurfacing systemUS5800547Oct 24, 1996Sep 1, 1998Schafer Micomed GmbhVentral intervertebral implantUS5824093Jun 6, 1997Oct 20, 1998Raymedica, Inc.Prosthetic spinal disc nucleusUS5860973Oct 30, 1996Jan 19, 1999Michelson; Gary KarlinTranslateral spinal implantUS5861041Apr 7, 1997Jan 19, 1999Arthit SitisoIntervertebral disk prosthesis and method of making the sameUS5888220Jan 23, 1996Mar 30, 1999Advanced Bio Surfaces, Inc.Articulating joint repairUS5888227Oct 3, 1996Mar 30, 1999Synthes (U.S.A.)Inter-vertebral implantUS5888228Oct 20, 1995Mar 30, 1999Synthes (U.S.A.)Intervertebral implant with cage and rotating elementUS5893889Jun 20, 1997Apr 13, 1999Harrington; MichaelArtificial discUS5919236Aug 22, 1997Jul 6, 1999Cerasiv Gmbh - Innovatives Keramik EngineeringJoint prosthesisUS5944759Sep 10, 1997Aug 31, 1999Waldemar Link (Gmbh & Co)Joint endoprosthesisUS5980522Nov 21, 1997Nov 9, 1999Koros; TiborExpandable spinal implantsUS5989289Oct 9, 1997Nov 23, 1999Sdgi Holdings, Inc.Bone graftsUS5989291Feb 26, 1998Nov 23, 1999Third Millennium Engineering, LlcIntervertebral spacer deviceUS6033438Jun 3, 1997Mar 7, 2000Sdgi Holdings, Inc.Open intervertebral spacerUS6048345Apr 8, 1999Apr 11, 2000Joseph J. BerkeMotorized reciprocating surgical file apparatus and methodUS6079868Mar 2, 1998Jun 27, 2000Advanced Bio Surfaces, Inc.Static mixerUS6080193Sep 15, 1998Jun 27, 2000Spinal Concepts, Inc.Adjustable height fusion deviceUS6096038Jun 7, 1995Aug 1, 2000Michelson; Gary KarlinApparatus for inserting spinal implantsUS6096080Feb 10, 1999Aug 1, 2000Cortek, Inc.Apparatus for spinal fusion using implanted devicesUS6102950Jan 19, 1999Aug 15, 2000Vaccaro; AlexIntervertebral body fusion deviceUS6110210Apr 8, 1999Aug 29, 2000Raymedica, Inc.Prosthetic spinal disc nucleus having selectively coupled bodiesUS6113638Feb 26, 1999Sep 5, 2000Williams; Lytton A.Method and apparatus for intervertebral implant anchorageUS6117174Sep 16, 1998Sep 12, 2000Nolan; Wesley A.Spinal implant deviceUS6132472Mar 5, 1999Oct 17, 2000Bonutti; Peter M.Tissue press and systemUS6139579Oct 31, 1997Oct 31, 2000Depuy Motech Acromed, Inc.Spinal discUS6140452Nov 18, 1998Oct 31, 2000Advanced Bio Surfaces, Inc.Polyetherurethane prepolymer reacted with hydrophobic hydroxy-or amine-endcapped addition polymerUS6143033Dec 23, 1998Nov 7, 2000Synthes (Usa)Allogenic intervertebral implantUS6146422Jan 25, 1999Nov 14, 2000Lawson; Kevin JonProsthetic nucleus replacement for surgical reconstruction of intervertebral discs and treatment methodUS6159211Oct 22, 1998Dec 12, 2000Depuy Acromed, Inc.Stackable cage system for corpectomy/vertebrectomyUS6174311Oct 28, 1998Jan 16, 2001Sdgi Holdings, Inc.Interbody fusion grafts and instrumentationUS6176882Feb 19, 1999Jan 23, 2001Biedermann Motech GmbhIntervertebral implantUS6183517Dec 16, 1998Feb 6, 2001Loubert SuddabyExpandable intervertebral fusion implant and applicatorUS6190414Oct 31, 1996Feb 20, 2001Surgical Dynamics Inc.Apparatus for fusion of adjacent bone structuresUS6206923Jan 8, 1999Mar 27, 2001Sdgi Holdings, Inc.Flexible implant using partially demineralized boneUS6652587 *Jun 12, 2002Nov 25, 2003Advanced Bio Surfaces, Inc.Method and system for mammalian joint resurfacingUS7267690 *Mar 9, 2006Sep 11, 2007Vertebral Technologies, Inc.Interlocked modular disc nucleus prosthesisUS7591853 *Mar 9, 2006Sep 22, 2009Vertebral Technologies, Inc.Rail-based modular disc nucleus prosthesisUS20050154463 *Jan 6, 2005Jul 14, 2005Trieu Hal H.Spinal nucleus replacement implants and methodsUS20060142858 *Dec 16, 2005Jun 29, 2006Dennis ColleranExpandable implants for spinal disc replacementUS20060167550 *Oct 8, 2003Jul 27, 2006Robert SnellHigh precision manufacture of polyurethane products such as spinal disc implants having a gradual modulus variationUS20060259144 *Jul 17, 2006Nov 16, 2006Warsaw Orthopedic Inc.Hybrid intervertebral disc systemUS20080133017 *Nov 15, 2005Jun 5, 2008Disc-O- Tech Medical TechnologyAssembled Prosthesis Such as a Disc* Cited by examinerNon-Patent CitationsReference1"Get ADR.com Top Surgeons-Latest Orthopedic Options (Artificial Disc Replacement)", http://www.getadr.com, Nov. 29, 2005. 3 pages.2"Get ADR.com Top Surgeons-Latest Orthopedic Options (Prestige Cervical ADR)", http://www.getadr.com/prestige.htm, Nov. 29, 2005. 2 pages.3"Get ADR.com Top Surgeons-Latest Orthopedic Options", http://www.getadr.com/link.htm, Nov. 29, 2005. 2 pages.4"Get ADR.com Top Surgeons-Latest Orthopedic Options", http://www.getadr.com/maverick.htm, Nov. 29, 2005. 2 pages.5"Get ADR.com Top Surgeons�Latest Orthopedic Options (Artificial Disc Replacement)", http://www.getadr.com, Nov. 29, 2005. 3 pages.6"Get ADR.com Top Surgeons�Latest Orthopedic Options (Prestige Cervical ADR)", http://www.getadr.com/prestige.htm, Nov. 29, 2005. 2 pages.7"Get ADR.com Top Surgeons�Latest Orthopedic Options", http://www.getadr.com/link.htm, Nov. 29, 2005. 2 pages.8"Get ADR.com Top Surgeons�Latest Orthopedic Options", http://www.getadr.com/maverick.htm, Nov. 29, 2005. 2 pages.9Anderson et al., "Macintosh Arthroplasty in Rheumatoid Arthritis," Department of Orthopaedic Surgery and Department of Rheumatology, The London Hospital, London, England, 1974, pp. 245-259.10Application and File History for U.S. Appl. No. 10/098,601, filed Mar. 15, 2002, inventor Felt.11Application and File History for U.S. Appl. No. 10/167,963, filed Jun. 12, 2002, inventor Felt.12Application and File History for U.S. Appl. No. 10/722,019, filed Nov. 24, 2003, inventor Felt.13Application and File History for U.S. Appl. No. 11/328,498, filed Jan. 9, 2006, inventor Sweeney et al.14Application and File History for U.S. Appl. No. 11/328,498, filed Jan. 9, 2006, inventor Sweeney II.15Application and File History for U.S. Appl. No. 11/372,357, filed Mar. 9, 2006, inventor Felt.16Application and File History for U.S. Appl. No. 11/372,477, filed Mar. 9, 2006, inventor Felt.17Application and File History for U.S. Appl. No. 11/489,264, filed Jul. 19, 2006, inventor Palm.18Application and File History for U.S. Appl. No. 11/900,209, filed Sep. 10, 2007, inventor Felt.19Application and File History for U.S. Appl. No. 11/900,209, filed Sep. 9, 2007, inventor Felt.20Application and File History for U.S. Appl. No. 11/953,203, filed Dec. 10, 2007, inventor Felt et al.21Application and File History for U.S. Appl. No. 11/953,203, filed Dec. 10, 2007, inventor Felt.22Application and File History for U.S. Appl. No. 11/974,185, filed Oct. 11, 2007, inventor Felt.23Application and File History for U.S. Appl. No. 12/435,087, filed May 4, 2009, inventor Felt.24Application and File History for U.S. Appl. No. 12/479,402, filed Jun. 5, 2009, inventor Felt et al.25Application and File History for U.S. Appl. No. 12/479,402, filed Jun. 5, 2009, inventor Felt.26Application and File History for U.S. Appl. No. 12/548,225, filed Aug. 26, 2009, inventor Felt et al.27Application and File History for U.S. Appl. No. 12/548,225, filed Aug. 26, 2009, inventor Felt.28Australian Office Action for Australian patent application No. 2010200382 dated Mar. 24, 2011.29Cameron et al., "Review ofa Failed Knee Replacement and Some Observations on the Design of a Knee Resurfacing Prosthesis," Archives of Orthopaedic and Traumatic Surgery, vol. 97, No. 1, 1980, pp. 87-89.30Chinese Office Action for Chinese Application No. 200680018453.0 (Details of the First Office Action) dated Jan. 12, 2011.31Chinese Office Action for Chinese Application No. 200680034261.9 dated Jun. 4, 2010.32Clary et al., "Experience with the MacIntosh Knee Prosthesis," Southern Medical Journal, Journal of the Southern Medical Association, Mar. 1972, vol. 65, No. 3, pp. 265-272.33Cluett, "Discetomy-Spinal Surgery to remove herniated disc", Nov. 29, 2005. 3 pages. http://orthopedica.about.com/cs/herniateddisk/a/repturedisk-3.htm.34Cluett, "Discetomy�Spinal Surgery to remove herniated disc", Nov. 29, 2005. 3 pages. http://orthopedica.about.com/cs/herniateddisk/a/repturedisk�3.htm.35Cluett. Jonathan, "Discectomy-Spinal Surgery to Remove a Herniated Disc", http://orthopedics.about.com/cs/herniateddisk/a/ruptureddisk-3.htm, Nov. 29, 2005. 3 pages.36Cluett. Jonathan, "Discectomy�Spinal Surgery to Remove a Herniated Disc", http://orthopedics.about.com/cs/herniateddisk/a/ruptureddisk�3.htm, Nov. 29, 2005. 3 pages.37Conaty, "Surgery of the Hip and Knee in Patients with Rheumatoid Arthritis," The Arthritis Servie (surgery) of Rancho, Los Amigos Hospital, Downey, Mar. 1973, vol. 55-A, No. 2, pp. 301-314.38Emerson et al., "The Use of the McKeever metallic Hemiarthroplasty for Unicompartmental Arthritis," The Journal of Bone and Joint Surgery, 1985, pp. 208-212.39Get ADR.com Top Surgeons-Latest Orthopedic Options (Artificial Disc Replacement) . Nov. 29, 2005. 3 pages http://www.getadr.com.40Get ADR.com Top Surgeons�Latest Orthopedic Options (Artificial Disc Replacement) . Nov. 29, 2005. 3 pages http://www.getadr.com.41Get ADR.com Top Surgeons-Latest Orthopedic Options (Prestige Cervical ADR) . Nov. 29, 2005. 3 pages http://www.getadr.com/prestige.htm.42Get ADR.com Top Surgeons�Latest Orthopedic Options (Prestige Cervical ADR) . Nov. 29, 2005. 3 pages http://www.getadr.com/prestige.htm.43Get ADR.com Top Surgeons-Latest Orthopedic Options. Nov. 29, 2005. 2 pages http://www.getadr.com/link.htm.44Get ADR.com Top Surgeons�Latest Orthopedic Options. Nov. 29, 2005. 2 pages http://www.getadr.com/link.htm.45Get ADR.com Top Surgeons-Latest Orthopedic Options. Nov. 29, 2005. 2 pages http://www.getadr.com/maverick.htm.46Get ADR.com Top Surgeons�Latest Orthopedic Options. Nov. 29, 2005. 2 pages http://www.getadr.com/maverick.htm.47Hastings, "Double Hemiarthroplasty of the Knee in Rheumatoid Arthritis," The Journal of Bone and Joint Surgery, Feb., 1973, vol. 55 B, No. 1, pp. 112-118.48Image File Wrapper for US. Appl. No. 12/479,402.49Image File Wrapper for US. Appl. No. 12/548,225.50International Preliminary Report on Patentability for International Application No. PCT/US2007/024262 dated Jun. 4, 2009.51International Search Report for International Application No. PCT/US06/20152 dated Sep. 12, 2008.52International Search Report for International Application No. PCT/US07/24262 dated Oct. 30, 2008.53International Search Report for International Application No. PCT/US2006/000558 dated Jul. 18, 2006.54Jessop et al., "Follow-up of the Macintosh Arthroplasty of the Knee Joint," Rheum. Phys. Med., 1972, vol. XI, No. 5, pp. 224.55Kay et al., "The Macintosh Tibial Plateau Hemiprosthesis for the Rheumatoid Knee," The Journal of Bone and Joint Surgery, May 1972, vol. 54B, No. 2, pp. 256-262.56Kozinn et al., "Surgical Treatment of Unicompartmental Degenerative Arthritis of the Knee," Rheumatic Disease Clinics of North America, Dec. 1988, vol. 14, No. 3, pp. 545-564.57Macintosh et al., "The Use of the Hemiarthroplasty Prosthesis for Advanced Osteoarthritis and Rheumatoid Arthritis of the Knee," The Journal of Bone and Joint Surgery,May 1972, vol. 54 B, No. 2, pp. 244-255.58McCallum et al., "Duplication of Medial Erosion in Unicompartmental Knee Arthroplasties," The Journal of Bone and Joint Surgery, 1995, pp. 726-728.59McCollum et al., "Tibial Plateau Prosthesis in Arthroplasty of the Knee," The Journal of Bone and Joint Surgery, Jun. 1970, vol. 52-A., No. 4, pp. 827-828.60McKeever, "Tibial Plateau Prosthesis," The Classic, pp. 3-12, Jan.-Feb. 1985.61Office Action, dated Jul. 26, 2010, of related U.S. Appl. No. 11/953,203.62Office Action, dated Jul. 7, 2010, of related U.S. Appl. No. 11/900,209.63Porter, "MacIntosh Athroplasty: a long-term review," J.R. Coll. Surg. Edinb., Aug. 1988, vol. 33, pp. 199-201.64Potter, "Arthroplasty of the Knee in Rheumatoid Arthritis and Osteoarthritis," The Journal of Bone and Joint Surgery, Jan. 1972, vol. 54-A, No. 1, pp. 1-24.65Potter, "Arthroplasty of the Knee with Tibial Metallic Implants of the McKeever and MacIntosh Design," Surgical Clinics of North America, Aug. 1969, vol. 49, No. 4, pp. 903-915.66Powers et al., "Minimally Invasive Fusion and Fixation Techniques," Neurosurg. Clin N Am, 2006, pp. 477-489.67RSB Spine, LLC, "510(k) Summary," Sep. 18, 2007, 4 pages, Cleveland, Ohio.68Ryortho, "Here comes ProDisc" Orthopedics This Week, vol. 2, Issue 3.(published prior to Janary 19, 2006).69Sbarbaro, "Hemitibial plateau prosthesis ten years experience in 500 knee arthroplasties," Acta Orthopaedica Belgica, 1973, pp. 91-100.70Schorn et al., "MacIntosh Arthroplasty in Rheumatoid Arthritis," Rheumatology and Rehabilitation, vol. XVII, No. 3, pp. 155-163.71Scott et al., "McKeever Metallic Hemiarthroplasty of the Knee in Unicompartmental Degenerative Arthritis," The Journal of Bone and Joint Surgery, Feb. 1985, vol. 67-A, No. 2, pp. 203-207.72Shin et al., "Posterior Lumbar Interbody Fusion via a Unilateral Approach," Yonsei Medical Journal, 2006, vol. 47, pp. 319-325.73Spine-Tech, Inc., "Summary of Safety and Effectiveness," May 23, 1996, 100 pages, Minneapolis, Minnesota.74Stauffer et al., "The MacIntosh Prosthesis, Prospective Clinical and Gait Evaluation," Arch Surg, Jun. 1975, vol. 110, pp. 717-720.75Summarized English Translation of Japanese Office Action for Japanese Application No. 2008-513686 dated Feb. 1, 2011.76Swanson et al., "Unicompartmental and Bicompartmental Arthroplasty of the Knee with a Finned Metal Tibial-Plateau Implant," The Journal of Bone and Joint Surgery, Oct. 1985, vol. 67-A, No. 8, pp. 1175-1182.77Synthes Spine, "510 (k) Summary-Revised Sep. 2007" 5 pages, Sep. 14, 2007West Chester, Pennsylvania.78Synthes Spine, "510 (k) Summary�Revised Sep. 2007" 5 pages, Sep. 14, 2007West Chester, Pennsylvania.79Tan et al., Interbody Device Shape and Size are Important to Strengthen the Vertebra-Implant Interface, SPINE 2005. vol. 30, No. 6. pp. 638-644.80Tan et al., Interbody Device Shape and Size are Important to Strengthen the Vertebra�Implant Interface, SPINE 2005. vol. 30, No. 6. pp. 638-644.81Taylor et al., "MacIntosh arthroplasty in rheumatoid arthritis," Proceedings and Reports of Universities, Colleges, Councils and Associations, pp. 119-120.82Toth et al., "Polyehteretherketone as a biomaterial for spinal applications," Biomaterials, 2006, pp. 324-334.83Transaction History for U.S. Appl. No. 10/121,455, filed Apr. 12, 2002, inventor Felt.84U.S. Appl. No. 12/479,402, filed Jun. 5, 2009, Felt et al.85U.S. Appl. No. 12/548,225, filed Aug. 26, 2009, Felt et al.86Vadapalli et al., "Biomechanical Rationale for Using Polyetheretherketone (PEEK) Spacers for Lumbar Interbody Fusion-A Finite Element Study," SPINE, 2006, vol. 31, No. 26, pp. E992-E998.87Vadapalli et al., "Biomechanical Rationale for Using Polyetheretherketone (PEEK) Spacers for Lumbar Interbody Fusion�A Finite Element Study," SPINE, 2006, vol. 31, No. 26, pp. E992-E998.88Vertebral Technologies, "InterFuse � Interbody Fusion System," 2009, pamphlet.89Wayne, "Use of the McIntosh Prosthesis in Surgical Reconstruction of the Knee," Abstracts of the 1971 Proceedings, Jun. 1972, No. 85, pp. 292-293.90Wordsworth et al., "MacIntosh Arthroplasty for the rheumatoid knee: a 10-year follow up," Annals of the Rheumatic Diseases, 1985, pp. 738-741.91Zwillich, Artificial Spinal Disc Nears Approval. WebMD Medical News. Nov. 29, 2005. 4 pages. http://www.webmd.com/content/article/88/9801.htm.92Zwillich, Todd, "Artificial Spinal Disc Nears Approval", WebMD Medical News, http://www.webmd.com/content/article/88/99801.htm, Nov. 29, 2005. 4 pages.Classifications U.S. Classification623/17.16International ClassificationA61F2/44Cooperative ClassificationA61F2/4611, A61F2002/444, A61F2002/30604, A61F2002/30016, A61F2002/30166, A61F2002/30387, A61F2002/30563, A61F2002/30235, A61F2002/4627, A61F2002/30014, A61F2220/0025, A61F2230/0069, A61F2/4455, A61F2002/30677, A61F2002/3052, A61F2/442, A61F2/3094, A61F2002/30561, A61F2250/0018, A61F2230/0028, A61F2002/30594European ClassificationA61F2/46B7, A61F2/44DLegal EventsDateCodeEventDescriptionFeb 1, 2012ASAssignmentOwner name: SUMMIT FINANCIAL RESOURCES, L.P., UTAHFree format text: SECURITY AGREEMENT;ASSIGNOR:VERTEBRAL TECHNOLOGIES, INC.;REEL/FRAME:027631/0930Effective date: 20120127Feb 18, 2008ASAssignmentOwner name: VERTEBRAL TECHNOLOGIES, INC., MINNESOTAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:FELT, JEFFREY;REEL/FRAME:020521/0585Effective date: 20071105RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google