US 20070093822 A1
Implants and methods for osteopathic augmentation and repositioning of vertebrae may comprise a chain having one or more beads or bodies configured for insertion into a vertebral body. The one or more bodies may be expandable. As the chain is inserted into the vertebral body, it may fill a central portion thereof and can push against the inner sides of the endplates of the vertebral body, thereby providing structural support and tending to restore the vertebral body to its original height. The one or more bodies may have a first configuration dimensioned to pass through a catheter or other introducer, and may expand to a second, larger configuration after insertion into the bone in order to secure the chain within the bone.
1. An apparatus for osteopathic augmentation comprising:
an anchoring element for securing to a vertebra;
a tensioning member for applying a tension to the anchoring element to move the vertebra into a desired position; and
a longitudinal fixation member for securing the tensioning member to fix the vertebra in the desired position, the longitudinal fixation member comprising one or more slots,
wherein each of the one or more slots have a first dimension configured to allow the tensioning member to be inserted through the one or more slots and a second dimension configured to releasably secure the tensioning member.
2. An apparatus according to
3. An apparatus according to
4. An apparatus according to
5. An apparatus according to
6. A method of repositioning a spine comprising the steps of:
inserting one or more anchor elements into one or more vertebrae;
attaching a tensioning member to each anchoring element using attachment means;
applying a tensioning force to the tensioning members to reposition the vertebrae and restore a desired curvature to the spine;
applying one or more longitudinal fixation members along a long axis of the spine, wherein the tensioning members pass through an opening in the longitudinal fixation member; and
securing the tensioning members to the longitudinal fixation members to maintain the desired spinal curvature.
7. A method according to
8. A method according to
9. An apparatus for osteopathic augmentation comprising:
a chain of expandable bodies linked by one or more linking members, the chain of expandable bodies configured for implantation into a bone,
wherein one or more of the expandable bodies in the chain changes from a first configuration before the implantation to a second configuration after the implantation.
10. An apparatus according to
11. An apparatus according to
12. An apparatus according to
13. An apparatus according to
14. An apparatus according to
15. An apparatus according to
16. An apparatus for repositioning bone, comprising:
an anchoring element for securing to a vertebra, the anchoring element comprising an expandable body adapted to expand from a first configuration before implantation within the vertebra to a second configuration after implantation within the vertebra;
a tensioning member for applying a tension to the anchoring element to move the vertebra into a desired position; and
a longitudinal fixation member for securing the tensioning member to fix the vertebra in the desired position, the longitudinal fixation member comprising one or more slots, each of the one or more slots having a first dimension configured to pass the tensioning member and a second dimension configured to releasably secure the tensioning member.
17. An apparatus according to
18. An apparatus for osteopathic augmentation comprising:
a chain comprising a plurality of linked bodies, the plurality of linked bodies being connected by segmented linking members,
wherein each of the plurality of linked bodies may comprise a shell formed from a resorbable membrane and the inside may comprise at least one of bone cement, osteoinductive, and osteoconductive material.
19. An apparatus according to
20. An apparatus according to
21. An apparatus according to
The present application claims priority to U.S. Provisional Application Nos. 60/725,773 filed Oct. 12, 2005; 60/715,188 filed Sep. 8, 2005; 60/728,442 filed Oct. 19, 2005; 60/730,909 filed Oct. 27, 2005; 60/733,026 filed Nov. 3, 2005; 60/722,064 filed Sep. 28, 2005; 60/726,835 filed Oct. 13, 2005; 60/733,647 filed Nov. 4, 2005; 60/753,782 filed Dec. 23, 2005; 60/789,956 filed Apr. 5, 2006; and 60/748,377 filed Dec. 8, 2005, and U.S. patent application Ser. No. 11/471,169 filed on Jun. 19, 2006.
The invention relates to surgical implants, and more particularly to minimally invasive apparatus and methods for augmenting and/or repositioning vertebrae and restoring of spinal lordosis.
Vertebral compression fractures, as illustrated in
More recently, minimally invasive surgical procedures for treating vertebral compression fractures have been developed. These procedures generally involve the use of a cannula or other access tool inserted into the posterior of the effected vertebral body through the pedicles. The most basic of these procedures is vertebroplasty, which literally means fixing the vertebral body, and may be done without first repositioning the bone.
Briefly, a cannula or special bone needle is passed slowly through the soft tissues of the back. Image guided x-ray, along with a small amount of x-ray dye, allows the position of the needle to be seen at all times. A small amount of polymethylmethacrylate (PMMA) or other orthopedic cement is pushed through the needle into the vertebral body. PMMA is a medical grade substance that has been used for many years in a variety of orthopedic procedures. Generally, the cement is mixed with an antibiotic to reduce the risk of infection, and a powder containing barium or tantalum, which allows it to be seen on the X-ray. Also, an iodine solution as an x-ray marker is often used in liquid form.
Vertebroplasty can be effective in the reduction or elimination of fracture pain, prevention of further collapse, and a return to mobility in patients. However, this procedure may not reposition the fractured bone and therefore may not address the problem of spinal deformity due to the fracture. It generally is not performed except in situations where the kyphosis between adjacent vertebral bodies in the effected area is less than 10 percent. Moreover, this procedure requires high-pressure cement injection using low-viscosity cement, and may lead to cement leaks in 30-80% of procedures, according to recent studies. In most cases, the cement leakage does no harm. In rare cases, however, polymethymethacrylate or other cement leaks into the spinal canal or the perivertebral venous system and causes pulmonary embolism, resulting in death of the patient.
More advanced treatments for vertebral compression fractures generally involve two phases: (1) reposition, or restoration of the original height of the vertebral body and consequent lordotic correction of the spinal curvature; and (2) augmentation, or addition of material to support or strengthen the fractured bone.
One such treatment, balloon kyphoplasty (Kyphon, Inc.), is illustrated in FIGS. 2A-D. A catheter having an expandable balloon tip is inserted through a cannula, sheath or other introducer into a central portion of a fractured vertebral body comprising relatively soft cancellous bone surrounded by fractured cortical bone (
Disadvantages of this procedure include the high cost, the repositioning of the endplates of the vertebral body may be lost after the removal of the balloon catheter, and the possible perforation of the vertebral endplates during the procedure. As with vertebroplasty, perhaps the most feared, albeit remote, complications related to kyphoplasty are related to leakage of bone cement. For example, a neurologic deficit may occur through leakage of bone cement into the spinal canal. Such a cement leak may occur through the low resistance veins of the vertebral body or through a crack in the bone which has not been appreciated previously. Other complications include; additional adjacent level vertebral fractures, infection and cement embolization. Cement embolization occurs by a similar mechanism to a cement leak. The cement may be forced into the low resistance venous system and travel to the lungs or brain resulting in a pulmonary embolism or stroke. Additional details regarding balloon kyphoplasty may be found, for example, in U.S. Pat. Nos. 6,423,083, 6,248,110, and 6,235,043 to Riley et al., each of which is incorporated by reference herein in its entirety.
Another approach for treating vertebral compression fractures is the Optimesh system (Spineology, Inc., Stillwater, Minn.), which provides minimally invasive delivery of a cement or allograft or autograft bone using an expandable mesh graft balloon, or containment device, within the involved vertebral body. The balloon graft remains inside the vertebral body after its inflation, which prevents an intraoperative loss of reposition, such as can occur during a kyphoplasty procedure when the balloon is withdrawn. One drawback of this system, however, is that the mesh implant is not well integrated in the vertebral body. This can lead to relative motion between the implant and vertebral body, and consequently to a postoperative loss of reposition. Additional details regarding this procedure may be found, for example, in published U.S. Patent Publication Number 20040073308, which is incorporated by reference herein in its entirety.
Still another procedure used in the treatment of vertebral compression fractures is an inflatable polymer augmentation mass known as a SKy Bone Expander. This device can be expanded up to a pre-designed size and Cubic or Trapezoid configuration in a controlled manner. Like the Kyphon balloon, once optimal vertebra height and void are achieved, the SKy Bone Expander is removed and PMMA cement or other filler is injected into the void. This procedure therefore entails many of the same drawbacks and deficiencies described above with respect to kyphoplasty.
A wide variety of other instruments and methods are known for the repositioning of vertebral bodies to correct deformations in alignment or spinal curvature of the spine that may result from vertebral compression fractures or other disorders. Such instruments and methods can generally involve the use of bone screws, also referred to as bone anchors, that may be implanted in to vertebrae. Once implanted, the bone screws may be used to mount a suitable spinal fixation instrumentation, such as clamps, rods, or plates. Such spinal instrumentation can then be used, to achieve and maintain correction of the spinal deformity and to stabilize the repositioned vertebrae while the vertebrae fuse together. For example, referring to FIGS. 3A-D, various methods 30A, 30B, 30C and 30D can be used to apply forces (as shown by small arrows 32) to reposition fractured or displaced vertebrae, e.g., fractured vertebrae 35 and displaced vertebrae 36. Bone screws 38, rods 39 or other apparatus may be used to apply such forces 32 and to maintain proper alignment of the spine 34.
In other systems, a separate reduction mechanism grasps the head of a bone screw implanted in a misaligned vertebral body. In such systems, the bone screw is generally braced against a rod or other longitudinal support element, and the screw head may be pulled to realign the vertebra toward the rod. For example,
A drawback of all of the above-described apparatus and systems is that the rod or longitudinal element is fully pulled into a clamping mechanism of the screw or anchoring element, and firmly engaged. Such an arrangement can be cumbersome and difficult to maneuver into an appropriate position for moving the vertebrae in the desired direction, particularly considering the relatively large size of the components of most of the above-described systems.
Accordingly, there remains a need in the art to provide safe and effective apparatus and methods for minimally invasive osteopathic augmentation and to reposition vertebral bodies and restore lordosis of the spine.
The present invention provides an apparatus and methods for vertebral augmentation, preferably minimally invasive vertebral augmentation, and repositioning of vertebral bodies. In one embodiment, the present invention provides an implant and method for correction of vertebral fractures and other disorders of the spine. For example, a chain of linked bodies may be inserted into a vertebral body damaged by a vertebral compression fracture. As linked bodies are inserted into a vertebral body, they may fill a central portion of the vertebral body and may push against the inner sides of the endplates of the vertebral body, thereby providing structural support and tending to restore the vertebra to its original height. Additionally, the flexibility of the chain between the linked bodies may lead to a thorough integration of the implant into the bone. The chain may comprise one or more linked bodies that are configured to expand after insertion, e.g., to secure the chain within the vertebral body.
In other embodiments, a chain may be inserted into a bone such as a vertebral body, e.g., through the lumen of a cannula or other sheath, and such sheath may be removed after implantation within the bone. In such embodiments, the chain, or a portion thereof, can remain within vertebral body, for example, to continue augmenting the vertebra and maintain proper lordosis. In other embodiments, a PMMA or another bone cement or filler can be inserted into the augmented bone, e.g., through the sheath or cannula, prior to, together with or after the chain to further enhance fixation or repair of the damaged region. In other embodiments, the chain or portions thereof can be coated with bone cement or filler and inserted into the bone. The bone cement or filler coating can be inserted in an active or inactive state, and if inactive, the cement or filler can be later activated. In other embodiments, a portion of the chain implant may be left extending out of the vertebral body, such that the extended portion of the chain can function as a tensioning member to reposition or realign the vertebral body. In still other embodiments, some or all of the linked bodies of the chain can be removed after repositioning the bone, and PMMA or another filler can be injected into a void created by the chain.
The bodies of the chain may be comprised of any biocompatible material having desired characteristics, for example a biocompatible polymer, metal, ceramic, composite, a shape memory alloy, or any combination thereof. The bodies may be joined in series by flexible or semi-flexible links, which may be comprised of any biocompatible material having desired characteristics of flexibility, strength, and the like. For example, in some embodiments the links between bodies may be comprised of a thread or other relatively thin structure, for example a fiber or strand, of a biocompatible polymer, metal, ceramic, composite or other material having desired characteristics. In some embodiments, the bodies and/or links may be resorbable.
In some embodiments, a method of treating bone may include inserting inside a fractured bone, for example a vertebrae, a chain comprising one or more linked bodies. A bone cement or other filler may be added with or without the implanted device to aid in stabilizing the bone and securing the implant in place within the bone. For example, bone graphing material, such as bone chips or demineralized bone may be added within the bone, and about the chain a small plug of bone cement may be used to fix the chain in the vertebrae. In some embodiments, an additional implant, e.g., a pedicle screw or other implant, may be used in combination with the chain implant.
In some embodiments, a method of restoring lordosis and/or repositioning a vertebral body may comprise implanting one or more chains into a vertebral body through a pedicle, wherein a portion of the one or more chains may extend posteriorly from the pedicle, and applying a tensioning force to the extended portion of the chain to alter the position of the vertebra. The chain may comprise expandable bodies or other structures that increase in size or otherwise change configuration after insertion, e.g., to secure the chain within the vertebra. The chain may or may not be further stabilized by bone cement or bone morphogenic materials (bone graft materials) inserted into the vertebrae and may or may not be further supplemented with bone cement to plug the opening and hold the chain in position. The extended portion of the chain may be secured to a fixation member inside or outside the body of the patient to maintain the desired position of the vertebra.
In some embodiments, an apparatus for correcting curvature of a spine may comprise at least one longitudinal fixation member, one or more anchoring elements for securing to one or more vertebrae, and one or more tensioning members securing each anchoring element to the longitudinal fixation member. Methods of using such apparatus for restoring and maintaining a desired spinal curvature may comprise inserting one or more anchoring elements into one or more vertebrae; attaching a tensioning member to each anchoring element using a fastener or other attachment means; applying a tension force to the tensioning members to reposition the vertebrae and restore a desired curvature to spine; applying one or more longitudinal fixation members along the long axis of the spine; and fixing the tensioning members to the longitudinal fixation to maintain the desired spinal curvature.
In another embodiment, a kit comprises various combinations of assemblies and components according to the present invention. A kit may include, for example, a cannula and a chain of linked bodies according to the present invention. In other embodiments, a kit may include an implant, a tensioning member and/or a longitudinal fixation member. Such embodiments may also comprise a syringe or other apparatus for injecting a cement or other filler into a vertebral body.
The invention and further developments of the invention are explained in even greater detail in the following exemplary drawings. The present invention can be better understood by reference to the following drawings, wherein like references numerals represent like elements. The drawings are merely exemplary to illustrate certain features that may be used singularly or in combination with other features and the present invention should not be limited to the embodiments shown.
FIGS. 2A-D are illustrations of a prior art method for treating a vertical compression fracture;
FIGS. 3A-D are schematic illustrations depicting various methods for applying forces to reposition fractured or displaced vertebrae;
FIGS. 18A-E are side cross-sectional view illustrations of a method of augmenting a vertebral body using a chain of linked bodies according to an embodiment of the present invention;
FIGS. 22A-D are side cross-sectional view illustrations of apparatus for repositioning, augmenting and stabilizing vertebral bodies according to an embodiment of the present invention;
FIGS. 23A-C are side cross-sectional view illustrations of a method of repositioning a damaged vertebral body according to an embodiment of the present invention;
FIGS. 32A-E are side cross-sectional view illustrations of apparatus for treating spinal deformities according to various embodiments of the present invention;
FIGS. 33 are side view illustrations depicting different configurations of linked bodies and chains according to various embodiments of the present invention;
A. Vertebral Augmentation Using Linked Bodies
In some embodiments, bodies 100 may be threaded upon a continuous or segmented thread, wire, fiber, strand or other elongated linking member 110. In other embodiments, each body 100 may be joined with adjacent bodies 100 by a segmented linking member. The one or more linking members 110 may be comprised of any biocompatible material having desired characteristics of flexibility, strength, and the like. For example, in some embodiments the linking members 110 between bodies 100 may be comprised of a wire or thread or other relatively thin structure of a biocompatible nylon, polymer, metal or any other material having desired characteristics. In some embodiments, bodies 100 and/or linking member 110 may be resorbable. The bodies 100 may be spaced along the linking member at uniform or nonuniform space increments, such that bodies 100 may or may not contact adjacent bodies.
As shown in FIGS. 33A-C, linked bodies and chains described herein may have any desired geometry and/or configuration. For example, chain 1000 (
As shown in
A passageway may be formed into the interior of the vertebral body using a drill or other instrument. The chain 1000 may then be inserted in the passageway and may compact or compress the bone material inside the vertebral body. Alternatively, after the passageway is formed in the vertebral body, instruments such as, for example, currettes or balloon catheter may be used to compress and compact the bone inside the vertebral body to create a cavity. The cavity in the vertebral body 12 also may be formed by removing bone material as opposed to compacting the bone. For example, a reamer, currette or other apparatus could be used to remove bone material from the inside of the vertebral body. Also, curettes and other instruments may be used to move the endplates of the vertebrae to correct curvature of the spine.
As more linked bodies 100 of chain 1000 are inserted into vertebral body 12, they may fill central portion 1112 and can push against inner sides of endplates 1114 and 1116, thereby tending to restore vertebral body 12 to its original height and provide structural support to stabilize vertebral body 12. Additionally, the flexibility of one or more linking members 110 between linked bodies 100 may allow bending of the chain within space 1112, e.g., in a uniform pattern or in a non-uniform or tortuous configuration, to aid in ensuring a thorough integration of the implant 1000 within the bone 12. Bone cement or other filler material may be used in conjunction with the inserted bodies 100 to move the vertebrae endplates to correct curvature of the spine.
In other embodiments, chain 1000 may be inserted into a bone such as a vertebral body 12, e.g., through the lumen of a cannula 1102 or other sheath, and such sheath may be removed after implantation within the bone 12. In such embodiments, chain 1000, or a portion thereof, may remain in vertebral body 12, for example, to continue augmenting the vertebra and maintain proper lordosis. In other embodiments, PMMA or another bone cement or filler (for example bone chips) may be inserted into vertebral body 12, e.g., through shaft and/or a cannula 1102, along with linked bodies 100 to further enhance fixation or repair of the damaged region. In other embodiments, some or all linked bodies 100 of chain 1000 may be removed after repositioning the bone, and PMMA or another bone cement or filler may be injected into a void created by chain 1000. Alternatively, a bone growth promoting filler may be inserted into vertebral body 12 and a plug of base cement utilized to hold the linked bodies and filler material in the vertebrae.
In some embodiments, chains 1000 may be implanted completely within vertebral body 12 as shown in
As shown in
FIGS. 18A-E are side cross-sectional view illustrations of a method of augmenting a vertebral body 12 using a chain 1000 of linked bodies according to one embodiment. As shown in
As shown in
In some embodiments, a cement or other substance (such as, for example, a polymer) may be injected into a bone, e.g., vertebra 12 along with chain 1000 of linked beads or bodies 100, simultaneously or otherwise. For example, a double lumen catheter (not shown) can be used, wherein the cement is injected through one lumen and the beads or bodies through another lumen. The cement and beads in the double lumen catheter could exit the catheter at different or the same places, and materials from the two lumens could enter vertebrae without mixing or contacting until they are injected into the vertebral space. Alternatively, the double lumen catheter could have one or more exit ports distributed throughout its length, or at least at one location, such that all or some of the cement contacts and is distributed over the beads before injection into the vertebrae or other bone. The catheter could remain a double lumen catheter or converge into a single lumen. Also, the beads and cement can be injected simultaneously through the same lumen. Alternatively, the beads can be injected through the lumen of the catheter and subsequently the cement or other material can be injected through the lumen in the catheter after the beads have been placed in the vertebrae, but while the beads still extend out of the vertebrae opening and while beads are still present in the catheter. Alternatively, or in addition, the cement or other material can be injected or placed in vertebrae before the beads.
In some embodiments, flexible chain 1000 may be coated with an adhesive or a polymer coating, such that chain 1000 may inserted into vertebral body 12 in a flexible state and may become hardened, tangled and/or convoluted during or after insertion. After insertion, bodies 100 may become attached together by the adhesive so that the flexible chain becomes a mass that may be locked into the vertebral body, or otherwise secured such that chain 1000 may not be easily removed through the insertion opening.
In other embodiments, linked bodies 100 may be coated with an adhesive and the chain may be inserted, with or without becoming tangled or convoluted, into a vertebral body 12. During or after insertion of some or all linking bodies 100 of a chain 1000, a portion of chain 1000 may be exposed to an energy source (e.g., an ultraviolet light, ultrasonic radiation, radio waves, heat, electric field, magnetic field), for example to activate the adhesive, such that the exposed portion of chain 1000 becomes joined to form a mass, or becomes rigid, or both, thereby further augmenting the vertebral body 12 and/or preventing removal of chain 1000 through the insertion opening.
B. Vertebral Repositioning and Restoration of Lordosis Using Linked Bodies
After repositioning the vertebral bodies 12 a and 12 b as shown in
As shown in
Referring now to FIGS. 22A-D, another method and apparatus for repositioning, augmenting and/or stabilizing vertebral bodies may comprise using an elongated fixation member 2200 having slotted holes 2202 or other features to releasably and adjustably secure chains 1000. For example, as shown in
In use, fixation member 2200 and chains 1000 may be used in a similar manner as described above with respect to
As shown in
In other embodiments, as shown in FIGS. 23A-C, vertebral bodies 12 a, 12 b and 12 c may be repositioned and/or augmented with fixation member 2200 remaining substantially outside of the body of the patient, e.g., outside skin 2010. Again using an example of a vertebral body 12 b damaged due to a compression fracture, adjacent vertebral bodies 12 a and 12 c may be augmented with chains 1000 and/or filler 1802 as described above. Ends 1002 of chains may extend posteriorly from vertebrae 12 a and 12 c and to the outside of the patient's body. An anchoring element 2300 may be inserted and/or secured into a posterior aspect of vertebra 12 b, for example through a pedicle. In some embodiments, anchoring element 2300 may be a screw or bolt, for example a monoaxial or polyaxial top loading pedicle screw, which may or may not have threads for securing to vertebra 12 b, and may or may not include a lumen 2304. In some embodiments, a needle 2306 or other elongated member may be passed through lumen 2304 of anchoring element 2300, for example to secure vertebra 12 b and/or provide a passage for injecting a bone filler or other material. Anchoring element 2300 may also include a flange, nut, fastener or other stop 2302 to secure against elongated fixation member 2200.
To reposition the alignment of vertebrae 12 a, 12 b and 12 c, and to increase the height of vertebra 12 b, tensioning forces 2312 and 2314 may be applied to chains 1000, and an opposing force 2310 may be applied to anchoring element as shown in
In some embodiments, as shown in
Turning now to
Exemplary methods of using the apparatus 2500 of
Referring now to
As shown in
Referring to FIGS. 32A-E, various different structures may be used to perform the functions of the anchoring element and/or tensioning member. For example, as shown in
In other embodiments, a bone screw 2510 or other anchoring element may be attached to: a wire 3210, for example as shown in
C. Expandable Linked Bodies
As shown in
In some embodiments, a chain implant 5000 may comprise one or more bodies or beads 5100 having expandable structures 5110, e.g. wings or other structures which may be conical or another desired shape, as shown for example in
As shown in
In other embodiments, the expandable beads may comprise coiled or rolled structure 5120, e.g., a ribbon as shown in
In other embodiments, expandable wings or other structures 5140 may be clipped or otherwise attached to a bead or linking member 5200 between beads 5100, e.g., as shown in
In other embodiments, the wings or other expandable structures on the bead or chain may be expanded by application of a energy source (e.g., an ultraviolet light, ultrasonic radiation, radio waves, heat, electric filed, magnetic field). For example, an expandable wing or other structure may comprise an electroactive polymer that may change shape or other configuration with a small electric current. Alternatively, the beads or bodies may comprise or be coated with a polymer or polymeric cement, which may be porous, that may expand or otherwise change configuration after contact with body fluids, saline, or another fluid or substance that may be present within the implanted area. The activating fluid or substance also may be administered into the implanted area at a desired time before, during or after injection of the beads or bodies. This may allow the beads to expand and lock in place in the vertebrae.
Another alternative to injecting cement with the beads is to utilize bodies or beads 5300 with cement, glue, polymer, or other adhesive or filler inside of the beads, e.g., within a hollow core or other cavity as shown in
As shown in
Expandable bodies and/or chains comprising one or more of such expandable bodies may be incorporated within any of the apparatus and methods described herein, e.g., for augmenting and/or repositioning vertebral bodies or other bones or structures.
D. Other Embodiments
Although the apparatus and methods described herein thus far have been described in the context of repositioning and augmenting vertebrae in the context of vertebral compression fractures and deformations in spinal curvature, various other uses and methods are envisioned. For example, in some embodiments, an implantable chain 1000 of linked bodies 100 may be used to reposition and/or augment other damaged bone regions such as a fractured or weak proximal femur 3700 as shown in
In some embodiments, the implants and methods described herein may be used in conjunction with other apparatus and methods to restore lordosis and augment vertebral body. For example, one or more chains 1000 or bone anchors 2510 may be used in conjunction with known procedures, e.g., a balloon kyphoplasty, that may be used to begin repositioning of a vertebral body and/or create a space within the body for chain 1000. In other embodiments, chains 1000, anchors 2510, tensioning members 2530 or other elements or devices described herein may be used in conjunction with other tools or external fixation apparatus for helping to manipulate or fix the vertebrae or other bones in a desired position.
In another embodiment, a kit comprises various combinations of assemblies and components may be provided. A kit may include, for example, a cannula and one or more chains 1000 of linked bodies 100 and/or expandable linked bodies according to the present invention. The one or more chains may be provided in different sizes, e.g., different lengths and/or diameters (widths). In other embodiments, a kit may include a cannula and/or sheath, one or more chains, and a syringe or other apparatus for injecting a cement or other filler into a vertebral body. In other embodiments, a kit may comprise one or more anchoring elements, one or more tensioning members, and one or more longitudinal fixation members. Such kit may also include, for example, a syringe or other container of a cement or other bone filler material. One skilled in the art will appreciate that various other combinations of devices, components and assemblies can be made and are intended to fall within the scope of the present invention.
In other embodiments, various minimally invasive implants and methods for alleviating discomfort associated with the spinal column may employ anchors and other implants described herein. For example, an implant comprising one or more linked bodies, for example within an expandable container (not shown), may be implanted between spinous processes of adjacent vertebrae to distract the processes and alleviate pain and other problems caused for example by spinal stenosis, facet arthropathy, and the like. For example, augmentation systems described herein may be used instead of or in addition to expandable interspinous process apparatus and methods described in U.S. Patent Publication number 2004/018128 and U.S. patent application Ser. No. 6,419,676 to Zucherman et al.
While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be understood that various additions, modifications and substitutions may be made therein without departing from the spirit and scope of the present invention as defined in the accompanying claims. In particular, it will be clear to those skilled in the art that the present invention may be embodied in other specific forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the spirit or essential characteristics thereof. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the foregoing description.