This invention relates to a facet joint implant and a method for distracting a facet joint and maintaining separation of the facet joint.
The facet joints, knees, and elbows are sometimes referred to as synovial joints. A synovial joint allows movement between two bones. In a synovial joint, the ends of the bones are covered with a material called articular cartilage. This material is a slick spongy material that allows the bones to glide against one another without much friction.
Surrounding the facet joint is a watertight sack made of soft tissue and ligaments. This sack creates what is called the “joint capsule”. The ligaments are soft tissue structures that hold the two sides of the facet joint together. The ligaments around the facet joint combine with the synovium to form the joint capsule that is filled with fluid (synovial fluid). This fluid lubricates the joint to decrease the friction.
The facet joint can often become painful during the degenerative process in the spine. Loss of disc height can reduce the separation of opposing facet joints and alters the biomechanics of those joints. The cartilage of the joint may become compromised or destroyed resulting in bone on bone contact in the joint. This may cause significant pain.
Currently, this type of pain is treated by anesthetic injections or surgical destruction of the nerves.
This invention provides a solution to one or more of the deficiencies and disadvantages described above.
In one broad respect, this invention is a method for repairing a facet joint of a human vertebra having a joint capsule surrounding the facet joint, comprising: introducing a synthetic elastic material into the facet joint. The synthetic elastic material can be introduced through the joint capsule into the facet joint or, alternatively, introduced through the bone into the facet joint to thereby maintain separation of the facet joint. In one representative embodiment, the synthetic elastic material can be a hydrogel. The synthetic elastic material can be introduced as a fully polymerized implant or, alternatively, as a polymerizable composition that polymerizes to form the hydrogel within the facet joint. The synthetic elastic material, in one embodiment, can be in a dehydrated or partially dehydrated form prior to introduction into the facet joint, and which swells upon hydration in the facet joint. In one embodiment, the method includes distracting the facet joint prior to introduction of the synthetic elastic material. In one embodiment, the synthetic elastic material is formed from polyacrylonitrile, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, poly methacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, epoxy polymers, or a combination of one or more of these materials.
In another broad respect, this invention is a method for repairing a facet joint of a human vertebra having a joint capsule surrounding the facet joint, comprising: introducing a solid swellable synthetic elastic material into the facet joint. In one embodiment, the synthetic elastic material is introduced through the joint capsule into the facet joint. In one embodiment, the synthetic elastic material is introduced through bone into the facet joint. In one embodiment, the method includes distracting the facet joint prior to introduction of the synthetic elastic material. In one embodiment, the elastic material swells after being introduced into the facet joint. In one embodiment, the synthetic elastic material is introduced in the form of a folded or rolled solid swellable polymerized implant. In one embodiment, the synthetic elastic material is an elastomer that is formed from polyacrylonitrile, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, poly methacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, epoxy polymers, or a combination of one or more of these materials.
In another broad respect, this invention is a method for repairing a facet joint of a human vertebra having a joint capsule surrounding the facet joint, comprising: introducing a polymerizable composition into the facet joint, wherein the polymerizable composition forms a synthetic elastic material in the facet joint. In one embodiment, the polymerizable composition is introduced through the joint capsule into the facet joint. In one embodiment, the polymerizable composition is introduced through bone into the facet joint. In one embodiment, the method includes distracting the facet joint prior to introduction of the polymerizable composition. In one embodiment, the synthetic elastic material is initially formed as a swellable polymerized composition which swells in the facet joint. In one embodiment, the synthetic elastic material is an elastomer that is formed from polyacrylonitrile, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, poly methacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, epoxy polymers, or a combination of one or more of these materials.
In another broad respect, this invention is an implant comprising a solid synthetic elastic material and adapted for use as a facet joint implant. The implant is thus of a size and dimensions during use that allow it to be used as a facet joint implant. The synthetic elastic material can be in the form of a swellable polymerized composition. The synthetic elastic material can be formed from polyacrylonitrile, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylic acid, poly methacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, epoxy polymers, or a combination of one or more of these materials. In one embodiment, the synthetic elastic material is in the form of a hydrogel.
In another broad respect, this invention is a method for manufacturing a facet implant, comprising forming a synthetic elastic material into an implant adapted for use as a facet implant in a human spine.
This invention provides a number of advantages, including but not limited to the following. The synthetic elastic material employed in the practice of this invention provides a surface to enhance lubrication within the facet joint, which can reduce pain associated with degenerated facet joints. The elastic material is relatively inexpensive. The method introduces the elastic material into the facet joint in a relatively non-invasive procedure. The elastic material is advantageously benign, biocompatible, elastic, and pliable, and can be formed from synthetic polymers previously used in the human body. Thus, at least some of the polymers that can be used in the practice of this invention are advantageously commercially available. When a solid elastic material is introduced into the facet joint, the elastic material can be introduced as an at least partially dehydrated solid in a shape that conforms to the cavity within the facet joint. In this regard, the at least partially dehydrated solid becomes re-hydrated after being introduced into the facet joint. The elastic material can thus swell to a larger size than the incision or hole that the elastic material is introduced through, thereby preventing the swelled elastic material from undesirably becoming expelled from the facet joint. Beneficially, the elastic material can be readily removed if, for example, it is later desired to remove the facet joint if a spinal fusion procedure is performed.
After it is determined that a facet joint is in need of the procedure discussed herein, it should be determined whether the facet joint should be distracted prior to introduction of the synthetic hydrogel into the facet joint 10. If needed, such as the size of the cavity is insufficient to allow introduction of the hydrogel, the distraction of the facet joint can be accomplished through techniques well known to one of skill in the art. In general, the distraction can be accomplished, for example, by wedging the facet joint apart, such as by using a ramped needle, screws, a wedge, an osteotome, or some specific delivery device.
Next, a synthetic elastomeric material is introduced into the cavity of the facet joint. The term “synthetic elastomeric material” refers to man-made materials such polymers, as opposed to naturally occurring materials such as collagen, naturally occurring proteins, cartilage and so on. In one embodiment, the synthetic elastomeric material is a hydrogel. As is known, hydrogels attract water. In general, the hydrogels used in the practice of this invention contain at least 25 percent by weight of water when fully hydrated and which contain this quantity of water in the facet joint. In one embodiment, the hydrogels contain at least 50 percent by weight of water and in certain embodiments contain at least 90 percent by weight of water. The hydrogels in general are inert, solid, elastic, pliable and biocompatible. The synthetic elastomeric material, such as a hydrogel, introduced into the facet joint provides relief from the facet joints rubbing each other, and may provide lubrication between the joints. The synthetic elastomeric material, including a hydrogel, can be fully hydrated when introduced into the facet joint, or can be, for example, introduced as a swellable material (e.g., a dehydrated sheet) that attracts water and swells/rehydrates once introduced into the joint.
The synthetic elastic material can be in the form of a polymerizable composition to be introduced into the facet joint or a fully polymerized composition. The final polymers can be cross-linked or not cross-linked. It should be appreciated that the polymerizable composition and the fully polymerized elastic material can be made from the same monomers and/or polymer precursors.
A polymerizable composition can be introduced into the cavity, which fully polymerizes within the cavity. The polymerizable material can be partially polymerized prior to introduction into the cavity. Depending on the type of polymerizable composition, a polymerization catalyst or initiator may be needed. In one embodiment, the polymerizable composition polymerizes in the facet joint to form an expandable elastic material, which swells up until its equilibrium water content is reached, i.e., a dehydrated elastic material is introduced into the cavity and swells as it rehydrates. The elastic material may be a hydrogel. However, the elastic material formed from the polymerizable composition in the joint need not necessarily be swellable to be useful in the practice of this invention.
As shown in
Alternatively, a fully polymerized synthetic elastic material can be introduced into the facet joint. In one embodiment, the polymer is an expandable synthetic elastic material (e.g., a hydrogel), which swells until its equilibrium water content is reached. For instance, a dehydrated synthetic elastic material is introduced into the cavity and swells as it rehydrates. If the synthetic elastic material used is a fully polymerized polymer to be introduced into the facet joint, it can be in the form of particles, or be in other forms such as in the form of a sheet or elongate rods (e.g., that resemble toothpicks). The sheet or elongate rods can be inserted through a minimally invasive hole either through the joint capsule or through the bone. If the sheet or elongate rods absorb water, the sheet or elongate rods expand upon absorbing water within the facet joint, thus creating a larger sheet or rod that will not exit the cavity through the hole in either the bone or the joint capsule. The implant, whether a sheet or otherwise, is of a size and shape adapted to be inserted into the cavity of the facet joint. In one embodiment, the sheet is inserted in a dehydrated, reduced size such as in a folded, coiled, wrapped, or rolled shape, which upon hydration opens into a sheet within the facet joint.
In the case of a fully polymerized, solid synthetic elastic material implant, an incision 22 can be made in the joint capsule 12 such as depicted in
Representative shapes of solid synthetic elastic materials are shown in
The polymers that can be used in the practice of this invention to make the polymerizable compositions and polymerized elastic materials (including hydrogels) include but are not limited to polyacrylonitrile, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, polymethacrylic acid, polyurethane, polyurea, polytetrafluoroethylene, cellulose triacetate, polydimethylsiloxane, polyacrylamide, polyethyleneoxide, copolymers of ethylene oxide and propylene oxide or hyaluronic acid, (pliable) epoxy polymers, and combinations thereof, as well as the monomers used to make such polymers. The polymers and copolymers of this invention can be made of monomers such as but not limited to that can be employed to make the polymers used in this invention include but are not limited to hydroxyalkyl acrylates such as 2-hydroxy ethyl methacrylate, acrylic acid, acrylonitrile, urea, ethylene oxide and propylene oxide, acrylamide, tetrafluoroethylene, dimethylsiloxane, monomers used to form polyurethane such as polyols and diisocyanates such as diphenylmethane diisocyanate (MDI), monomers used to form pliable epoxy resins, vinyl alcohol, methacrylates including alkyl methacrylates such as methyl methacrylate, N-vinyl monomers such as N-vinyl-2-pyrrolidone, ethylenically unsaturated acids such as methacrylic acid, ethylenically unsaturated bases such as 2-(diethylamino) ethyl methacrylate. The polymers can be made using well known techniques, and may be commercially available. Likewise, polymers can be readily formed into sheets and so on, as described herein, using well known techniques.
In general, if monomers and/or polymer precursors are introduced into the cavity, the monomers and/or polymer precursors react in the body to form the final polymeric composition. As used herein, “polymer precursor” (which can also be referred to as a “prepolymer”) refers to materials that are formed by the partial polymerization of monomers, such as to form chains by reaction of, for example, two to four monomer groups.
In some cases, depending on the type of monomers or polymer precursors employed, polymerization initiators or catalysts are required to cause polymerization. Such compounds can be, for example, free radical initiators. In other cases, heat or light (e.g., UV light) can serve to initiate polymerization.
Representative examples of suitable polymeric materials are described in U.S. Pat. No. 5,976,186, U.S. Pat. No. 6,264,695, U.S. Pat. No. 6,280,475, U.S. Pat. No. 6,443,988, and U.S. Pat. No. 6,595,998, each of which is incorporated herein by reference in their entirety.
The synthetic elastic materials can contain a variety of other additives, such as pharmaceutically active compounds, analgesics, antibiotics, nutrients, building blocks for tissue generation, and so on. Likewise, a lubricating composition may be introduced concurrent with the synthetic elastic materials, such as additional synovial fluid, hyaluronic acid, and so on. Also, the implants can include radiographic markers such as strips of tantalum wire.
Further modifications and alternative embodiments of this invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the manner of carrying out the invention. It is to be understood that the forms of the invention herein shown and described are to be taken as illustrative embodiments. Equivalent elements or materials may be substituted for those illustrated and described herein, and certain features of the invention may be utilized independently of the use of other features, all as would be apparent to one skilled in the art after having the benefit of this description of the invention.