Patent Publication Number: US-2017348115-A1

Title: Expandable support device and method of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 12/014,006, filed Jan. 14, 2008, which is a continuation of PCT Application No. PCT/US2006/027601, filed Jul. 14, 2006, which claims the benefit to U.S. Provisional Application Nos. 60/699,576 filed Jul. 14, 2005, and 60/752,183 filed Dec. 19, 2005, which are all herein incorporated by reference in their entireties. 
    
    
     BACKGROUND OF THE INVENTION 
     This invention relates to devices for providing support for biological tissue, for example to repair spinal compression fractures, and methods of using the same. 
     Vertebroplasty is an image-guided, minimally invasive, nonsurgical therapy used to strengthen a broken vertebra that has been weakened by disease, such as osteoporosis or cancer. Vertebroplasty is often used to treat compression fractures, such as those caused by osteoporosis, cancer, or stress. 
     Vertebroplasty is often performed on patients too elderly or frail to tolerate open spinal surgery, or with bones too weak for surgical spinal repair. Patients with vertebral damage due to a malignant tumor may sometimes benefit from vertebroplasty. The procedure can also be used in younger patients whose osteoporosis is caused by long-term steroid treatment or a metabolic disorder. 
     Vertebroplasty can increase the patient&#39;s functional abilities, allow a return to the previous level of activity, and prevent further vertebral collapse. Vertebroplasty attempts to also alleviate the pain caused by a compression fracture. 
     Vertebroplasty is often accomplished by injecting an orthopedic cement mixture through a needle into the fractured bone. The cement mixture can leak from the bone, potentially entering a dangerous location such as the spinal canal. The cement mixture, which is naturally viscous, is difficult to inject through small diameter needles, and thus many practitioners choose to “thin out” the cement mixture to improve cement injection, which ultimately exacerbates the leakage problems. The flow of the cement liquid also naturally follows the path of least resistance once it enters the bone—naturally along the cracks formed during the compression fracture. This further exacerbates the leakage. 
     The mixture also fills or substantially fills the cavity of the compression fracture and is limited to certain chemical composition, thereby limiting the amount of otherwise beneficial compounds that can be added to the fracture zone to improve healing. Further, a balloon must first be inserted in the compression fracture and the vertebra must be expanded before the cement is injected into the newly formed space. 
     A vertebroplasty device and method that eliminates or reduces the risks and complexity of the existing art is desired. A vertebroplasty device and method that is not based on injecting a liquid directly into the compression fracture zone is desired. 
     BRIEF SUMMARY OF THE INVENTION 
     An expandable support device for performing completely implantable spinal repair is disclosed. The device may include a near end portion and a far end portion with a number of backbone struts extending therebetween. The near and far end portions may be closed or have passage openings. In one variation of the invention the end portions can be non-expandable and can cause the implant to form a tapered profile when expanded. Adjacent backbone struts in the implant can be connected by a number of deformable support struts. The adjacent backbone struts can be affixed together or integral (e.g., when laser cut from a tube or other extrusion type piece). 
     The structure of the implant device can permit expansion in a number of directions. Variations of the implant can assume different cross-sectional shapes , where such shapes include a square, rectangular, triangular, or any such type of polygon where the sides are defined by the adjacent backbone struts and associated connecting support struts. Furthermore, the shapes may also be rounded, tapered, rectangular (e.g., where the aspect ratio may not be 1 to 1.) 
     An expandable support device for placement within or between spinal vertebral bodies is disclosed. The device can have a radially non-expandable near end portion, a radially non-expandable far end portion and a longitudinal axis extending therebetween. The device can have backbone struts parallel to the longitudinal axis. The backbone struts can each have a near end integral with the near end portion and a far end integral with the far end portion. The device can have deformable support struts located between each adjacent backbone strut. The support struts can have a support strut width perpendicular to the longitudinal axis. The support struts can have a support strut thickness parallel to the longitudinal axis. The support strut width can be greater than the support strut thickness. Each support strut can be deformable such that, upon longitudinal expansion of the expandable support device from a radially expanded configuration, the adjacent backbone struts approach each other while the support struts deform. One or more of the support struts can have a bend when the device is in a radially contracted configuration. The bend can define an edge having a surface that is coincidental with the outer surface of the expandable support device. When the device is in a radially contracted configuration a first length of the backbone struts can be the same shape as the first length of the backbone struts when the device is in a radially expanded configuration. When the device is in a radially expanded configuration, the device can have a lumen along the longitudinal axis. The lumen can be at least partially filled with a filler. An outer cross section of the device perpendicular to the longitudinal axis when the device is in a radially expanded configuration can be quadrilateral. Lengths of at least two backbone struts can be parallel with each other when the device is in a radially expanded configuration. 
     An expandable support device for placement within or between spinal vertebral bodies is disclosed. The device can have a radially non-expandable near end portion, a radially non-expandable far end portion and a longitudinal axis extending therebetween. The device can have backbone struts parallel to the longitudinal axis. The backbone struts can each have a near end integral with the near end portion and a far end integral with the far end portion. The device can have deformable support struts located between each adjacent backbone strut. Each support strut can be deformable such that, upon longitudinal expansion of the expandable support device from a radially expanded configuration, the adjacent backbone struts approach each other while the support struts deform. When the device is in a radially expanded configuration, the device can have a lumen along the longitudinal axis. The lumen can be at least partially filled with a filler. An outer cross section of the device perpendicular to the longitudinal axis when the device is in a radially expanded configuration can be quadrilateral. At least one support strut can have a bend when the device is in a radially contracted configuration. The bend can defines an edge having a surface that is coincidental with the outer surface of the expandable support device. 
     An expandable support device for placement within or between spinal vertebral bodies is disclosed. The device can have a radially non-expandable near end portion, a radially non-expandable far end portion and a longitudinal axis extending therebetween. The device can have backbone struts parallel to the longitudinal axis. The backbone struts can each have a near end integral with the near end portion and a far end integral with the far end portion. The device can have deformable support struts located between each adjacent backbone strut. At least a first support strut and a second support strut located between an adjacent pair of backbone struts can be flat when the device is in a radially expanded configuration. Each support strut can be deformable such that, upon longitudinal expansion of the expandable support device from a radially expanded configuration, the adjacent backbone struts approach each other while the support struts deform. When the device is in a radially contracted configuration a first length of the backbone struts can be the same shape as the first length of the backbone struts when the device is in a radially expanded configuration. When the device is in a radially expandable configuration, the device can have a lumen along the longitudinal axis. The lumen can be at least partially filled with a filler. An outer cross section of the device perpendicular to the longitudinal axis when the device is in a radially expanded configuration can be quadrilateral. At least one support strut can have a bend when the device is in a radially contracted configuration. The bend can define an edge having a surface that is coincidental with the outer surface of the expandable support device. A flat plane can be defined by the outer surfaces of the support struts between a first backbone strut and a second backbone strut adjacent to the first backbone strut. 
     A method for repairing a damaged section of a spine is also disclosed. The method can include expanding an expandable support device in a treatment site such as a damaged section of bone (e.g., vertebra) or soft tissue (e.g., vertebral disc). The expandable support device can be loaded on a balloon during the expanding. The expansion of the device may be accomplished as described herein. For example, the expansion may include can include inflation of a balloon-type expansion device. Inflating the balloon can include inflating the balloon equal to or greater than about 5,000 kPa of internal pressure, or equal to or greater than about 10,000 kPa of internal pressure. 
     Expandable support devices for orthopedic applications, deployment tools and methods for using that same that can be deployed in a minimally invasive procedure are disclosed. For example, the expandable support devices can be deployed through 0.25 in. to 0.5 in. incisions. The expandable support devices can be, for example, metal and/or polymer self-assembling, self-forming structures. Imaging modalities can be used to maneuver the expandable support device inside the patient. 
     Further, expandable support devices, deployment tools and methods are disclosed for removing, resizing, and repositioning the expandable support devices are disclosed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a perspective view of a variation of the implant in an unexpanded configuration. 
         FIG. 2  illustrates a perspective view of the variation of the implant of  FIG. 1  in an expanded configuration. 
         FIG. 3  illustrates a side view of the variation of the implant of  FIG. 1 . 
         FIG. 4  shows a variation of the view along line  4 - 4  in  FIG. 3 . 
         FIG. 5  illustrates a side view of the variation of the implant of  FIG. 1  in an expanded configuration. 
         FIG. 6  shows a variation of the view along line  6 - 6  in  FIG. 4   
         FIGS. 7 and 8  illustrate a variation of a method for using a delivery system for the expandable support element. 
         FIGS. 9 through 11  illustrate a variation of a method for accessing a treatment site in the vertebra. 
         FIG. 12  illustrates various variations of methods for deploying the expandable support device to the vertebral column. 
         FIGS. 13 through 15  illustrate a variation of a method for deploying the expandable support device into the treatment site in the vertebra. 
         FIGS. 16 and 17  illustrate a variation of a method for deploying the expandable support device into the treatment site in the vertebra. 
         FIGS. 18 and 19  illustrate a variation of a method for deploying one or more expandable support devices into one or more treatment sites in the vertebra. 
         FIG. 20  illustrates a variation of a method for deploying the expandable support device into the treatment site in the vertebra. 
         FIG. 21  illustrates a variation of a method for deploying the expandable support device into the treatment site in the vertebra. 
         FIG. 22  illustrates a variation of a method for deploying multiple expandable support devices into one or more treatment sites in the vertebra. 
         FIGS. 23 and 24  illustrate a variation of a method for deploying the expandable support device into the treatment site in the vertebra. 
         FIGS. 25 and 26  illustrate a variation of a method for deploying the expandable support device between vertebral bodies. 
         FIGS. 27 through 29  illustrate a variation of a method for adjusting and/or retracting the expandable support device with an engagement device. 
         FIGS. 30 through 32  illustrate a variation of a method for adjusting and/or retracting the expandable support device with an engagement device. 
         FIGS. 33 and 35  illustrate a variation of a method for splitting the expandable support device with an engagement device. 
         FIG. 34  illustrates a variation of the engagement device having a cutting blade. 
         FIGS. 36 a  and 36 b    illustrate variations of a first portion and second portion, respectively, of the expandable support device that has been slit. 
         FIG. 37  illustrates a variation of a method for adjusting and/or retracting the expandable support device. 
         FIG. 38  illustrates a cross-sectional view of a method for deploying the expandable support device in a bone. 
         FIGS. 39 through 41  illustrate a variation of a method for overdeploying the expandable support device. 
         FIGS. 42 through 46  illustrate a method for deploying the expandable support device. 
     
    
    
     DETAILED DESCRIPTION 
       FIGS. 1 and 2  illustrate a biocompatible implant used for tissue repair, including, but not limited to repair of bone fractures such as spinal compression fractures, and/or repairing soft tissue damage, such as herniated/diseased vertebral discs. The impant can be used to perform vertebroplasty, and/or the implant can be used as a partial and/or complete vertebra and/or vertebral disc replacement, and/or for vertebral fixation. The implant can be an expandable support device  2 , for example a stent. The expandable support device  2  can have a longitudinal axis  4 . 
     The expandable support devices  2  can be used to provide structural reinforcement from inside one or more bones, as a replacement for one or more bones, or between bones. The expandable support devices can be used for a variety of orthopedic locations, such as in the vertebral column, for example, to treat compression fractures. Examples of expandable support devices and methods for use of expandable support devices, as well as devices for deploying the expandable support devices include those disclosed in the following applications which are all incorporated herein in their entireties: PCT Application Nos. US2005/034115, filed 21 Sep. 2005; US2005/034742, filed 26 Sep. 2005; US2005/034728, filed 26 Sep. 2005; US2005/037126, filed 12 Oct. 2005; U.S. Provisional Application Nos. 60/675,543, filed 27 Apr. 2005; 60/723,309, filed 4 Oct. 2005; 60/675,512, filed 27 Apr. 2005; 60/699,577, filed 14 Jul. 2005; 60/699,576, filed 14 Jul. 2005; and 60/752,183 filed 19 Dec. 2005. 
     The expandable support device  2  can have a plurality of backbone struts  12 . The backbone struts  12  can connect a near end portion  13  and a far end portion  14 . The backbone struts  12  can each have a near end and a far end affixed to the respective end portions  13  and  14 . The expandable support device  2  can be constructed of separate structures that are fixed, integrated or otherwise joined together. The expandable support device  2  can be fabricated from a uniform stock of material (e.g., via laser cutting or electrical discharge machining (EDM)). Adjacent backbone struts can be joined by a number of deformable support struts  10 . The support struts  10  can have a thinner cross sectional thickness than most of the remainder of the stent. This feature allows for pre-determined deformation of the stent  2  to take place. 
     The support struts  10  may also serve to distribute load across the backbone strut. In such cases, the number of support struts will determine the degree to which the backbone struts are supported. 
     The expansion ratio of the expandable support device  2  can be, for example, about 3 or about 4 times the initial diameter of the expandable support device  2 . The expansion ratio can be selected as required for the particular procedure. For example, in the pre-expanded configuration the expandable support device  2  can have an initial diameter of about 6.3 mm (0.25 in.), while in the expanded configuration, the diameter can be about 9.5 mm (0.37 in.). In a further example, the expandable support device  2  can have an initial diameter of about 5 mm (0.2 in.), while in the expanded configuration, the diameter can be about 20 mm (0.8 in.). 
     In the pre-expanded configuration, the cross-sectional shape of the expandable support device  2  can be circular, triangular, oval, rectangular, square, or any type of polygon and/or rounded, and/or tapered shape. Upon expansion, the expandable support device  2  can form a polygon-type shape, or other shape as discussed herein. 
       FIG. 2  illustrates that the expandable support device  2  can expand such that the backbone struts  12  can expand away from the longitudinal axis  4 . The backbone struts  12  can remain substantially parallel to the axis  4 . The support struts  10  can be configured to limit the expansion of the backbone struts  12 . The backbone struts  12  can be configured to prevent the backbone struts  12  from buckling. 
     The adjacent backbone struts  12  and accompanying support struts  10  can form a side of the implant. Although the variation illustrated in  FIGS. 1 through 6  shows four backbone struts  12 , and four support strutsl 0  per adjacent backbone struts  12  (and therefore four faces), the inventive device can have three or more sides, for example with the requisite number of backbone supports. The cross sectional areas of the expandable support device, can include triangular shapes, square shapes, rectangular shapes, and any type of polygon-shaped structure, for example when the expandable support device  2  is in an expanded configuration. The longitudinal length of each side of the expandable support device  2  can be equal to the other sides or sides of the expandable support device  2 . The longitudinal length of each side of the expandable support device  2  can be substantially different than the other sides or sides of the expandable support device  2 . 
     Any portion of the expandable support device  2  can have one or more ingrowth ports (not shown). The ingrowth ports can be configured to encourage biological tissue ingrowth therethrough during use. The ingrowth ports can be configured to releasably and/or fixedly attach to a deployment tool or other tool. The ingrowth ports can be configured to increase, and/or decrease, and/or focus pressure against the surrounding biological tissue during use. The ingrowth ports can be configured to increase and/or decrease the stiffness of either the backbone or support struts. 
     The expandable support device  2  can have any number of support struts  10 . The support struts  10  can have a substantially “V”-like shape that deforms or expands as the implant expands, such as shown in  FIG. 2 . The shape of the support struts  10  can be shapes other than the substantially “V”-like shape. The struts  10  can be configured as any shape to accommodate the expansion of the implant  2 . Such shapes can include a substantially “U”-like shape, a substantially “W”-like configuration, an substantially “S”-like configuration. The struts can have a combination of configurations in the same expandable support device  2 , for example, to time the expansion of portions of the implant or otherwise control the profile of the implant during expansion. 
     The expandable support device  2  can have a wall thickness from about 0.25 mm (0.098 in.) to about 5 mm (0.2 in.), for example about 1 mm (0.04 in.). The expandable support device  2  can have an inner diameter (e.g., between farthest opposing backbone structures). The inner diameter can be from about 1 mm (0.04 in.) to about 30 mm (1.2 in.), for example about 6 mm (0.2 in.). The wall thickness and/or the inner diameter can vary with respect to the length along the longitudinal axis  4 . The wall thickness and/or the inner diameter can vary with respect to the angle formed with a plane parallel to the longitudinal axis  4 . The wall thickness can be reduced at points where deformation is desired. For example, the wall thickness of the support struts  10  can be reduced where the backbone structure meets the end portions. 
       FIG. 3  illustrates that the implant  2  can have near and far end portions  13  and  14 . The near and far end portions  13  and  14  can be attached to each backbone strut via a near and far end of the backbone strut  12 . 
       FIG. 4  illustrates a front view of the implant  2  taken along the line  4 - 4  of  FIG. 3 . The end portions of the expandable support device  2  can have openings  16 . The opening  16  can be threaded to accommodate a threaded member. One or both of the end portions can be solid which allows for filling of the expandable support device  2  with materials described herein. The end portions can be expandable. The end portions can be non-expandable (i.e., rigid). 
       FIG. 5  illustrates that after expansion the backbone struts  18  can remain parallel to the longitudinal axis  4  and the ends of the backbone struts can form a taper with the near and far end portions  13  and  14 . 
       FIG. 6  illustrates a front view taken along the line  6 - 6  of  FIG. 5  of the expandable support device  2 . The expandable support device  2  can have a square cross sectional shape as the backbone struts  12  remain parallel to the longitudinal axis  4 . 
     The expandable support device  2  can have one or more protrusions on the surface of the expandable support device  2 . The protrusions can have features such as tissue hooks, and/or barbs, and/or cleats. The protrusions can be integral with and/or fixedly or removably attached to the expandable support device  2 . The expandable support device  2  can be configured (e.g., on the support struts  10  or other parts of the implant) to burrow into soft bone (e.g., cancellous or diseased), for example, until the device fully expands, or until the device hits the harder vertebral endplates. 
     Any or all elements of the expandable support device  2  and/or other devices or apparatuses described herein (e.g., including all deployment tools and their elements described below) can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyethylene teraphathalate (PET), polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, aromatic polyesters, such as liquid crystal polymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high molecular weight polyethylene (i.e., extended chain, high-modulus or high-performance polyethylene) fiber and/or yarn (e.g., SPECTRA® Fiber and SPECTRA® Guard, from Honeywell International, Inc., Morris Township, N.J., or DYNEEMA® from Royal DSM N.V., Heerlen, the Netherlands), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft, xenograft, bone cement, morselized bone, osteogenic powder, beads of bone) any of the other materials listed herein or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold. 
     Any or all elements of the expandable support device  2  and/or other devices or apparatuses described herein (e.g., including all deployment tools and their elements described below), can be, have, and/or be completely or partially coated with agents and/or a matrix a matrix for cell ingrowth or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix and/or fabric can be, for example, polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof. 
     The expandable support device  2  and/or elements of the expandable support device  2  and/or other devices or apparatuses described herein (e.g., including all deployment tools and their elements described below) and/or the fabric can be filled, coated, layered and/or otherwise made with and/or from cements, fillers, glues, and/or an agent delivery matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. Any of these cements and/or fillers and/or glues can be osteogenic and osteoinductive growth factors. 
     Examples of such cements and/or fillers includes bone chips, demineralized bone matrix (DBM), calcium sulfate, coralline hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate, polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs) such as recombinant human bone morphogenetic proteins (rhBMPs), other materials described herein, or combinations thereof. 
     The agents within these matrices can include any agent disclosed herein or combinations thereof, including radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck &amp; Co., Inc., Whitehouse Station, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®, from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Examples of other agents are provided in Walton et al, Inhibition of Prostoglandin E 2  Synthesis in Abdominal Aortic Aneurysms,  Circulation,  Jul. 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae,  Brit. J. Surgery  88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis,  Brit. J. Surgery  86 (6), 771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium,  J. Biological Chemistry  275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms,  J. Clinical Investigation  105 (11), 1641-1649 which are all incorporated by reference in their entireties. 
     Method of Use 
       FIG. 7  illustrates that the expandable support device  2  can be loaded in a collapsed (i.e., contracted) configuration onto a deployment tool  38 . The deployment tool  38  can have an expandable balloon catheter as known to those having an ordinary level of skill in the art. The deployment tool  38  can have a catheter  40 . The catheter  40  can have a fluid conduit  42 . The fluid conduit  42  can be in fluid communication with a balloon  44 . The balloon  44  and the deployment tool  38  can be the balloon  44  and deployment tool  38  as described by PCT Application No. US2005/033965 filed 21 Sep. 2005, which is herein incorporated by reference in its entirety. The balloon  44  can be configured to receive a fluid pressure of at least about 5,000 kPa (50 atm), more narrowly at least about 10,000 kPa (100 atm), for example at least about 14,000 kPa (140 atm). 
     The expandable support device  2  can be deployed and/or expanded with a force from a mechanical actuation device (e.g., as opposed to the balloon expansion). For example, the ends of the expandable support device  2  can move, or be moved, together to expand the backbone struts outward. The expandable support device  2  can be configured to be self-expand upon the removal of a restraint (e.g., when the expandable support device  2  is constructed from a resilient or super-elastic material). The expandable support device  2  can be made from a shape memory alloy that can have a pre-determined transition temperature such that expansion takes place due to temperature changes passively (e.g., from the patient&#39;s body heat) or actively (e.g., from thermal and/or electrical energy delivered to the expandable support device  2  from outside the patient) created during or after implantation. 
     The expandable support device  2  can be locked into the expanded configured with a locking structure (e.g., a center strut, ratchet type mechanism, screw, locking arm, combinations thereof) that can be integral with or separate from the remainder of the expandable support device  2 . The expandable support device  2  can be “locked” into the expanded position by filing the expandable support device  2  with cement, filler (bone chips, calcium sulfate, coralline hydroxyapatite, Biocoral, tricalcium phosphate, calcium phosphate, PMMA, bone morphogenic proteins, other materials described herein, or combinations thereof. 
     The deployment tool  38  can be a pair of wedges, an expandable jack, other expansion tools, or combinations thereof 
       FIG. 8  illustrates that the fluid pressure in the fluid conduit  42  and balloon can increase, thereby inflating the balloon  44 , as shown by arrows. The expandable support device  2  can expand, for example, due to pressure from the balloon  44 . 
       FIGS. 9  (side view) and  10  (top view) illustrates a group of bones, such as vertebral column  46 , that can have one or more bones, such as vertebra  48 , separated from the other vertebra  48  by soft tissue, such as vertebral discs  50 . The vertebra  48  can have a target or damage site  52 , for example a compression fracture. 
     An access tool  54  can be used to gain access to the damage site  52  and or increase the size of the damage site  52  to allow deployment of the expandable support device  2 . The access tool  54  can be a rotating or vibrating drill  56  that can have a handle  58 . The drill  56  can be operating, as shown by arrows  60 . The drill  56  can then be translated, as shown by arrow  62 , toward and into the vertebra  48  so as to pass into the damage site  52 . 
       FIG. 11  illustrates that the access tool  54  can be translated, as shown by arrow, to remove tissue at the damage site  52 . The access tool  54  can create an access port  64  at the surface of the vertebra  48 . The access port  64  can open to the damage site  52 . The access tool  54  can then be removed from the vertebra  48 . 
       FIG. 12  illustrates that a first deployment tool  38   a  can enter through the subject&#39;s back. The first deployment tool  38   a  can enter through a first incision  66   a  in skin  68  on the posterior side of the subject near the vertebral column  46 . The first deployment tool  38   a  can be translated, as shown by arrow  70 , to position a first expandable support device  2   a  into a first damage site  52   a.  The first access port  64   a  can be on the posterior side of the vertebra  48 . 
     A second deployment tool  38   b  can enter through a second incision  66   b  (as shown) in the skin  68  on the posterior or the first incision  66   a . The second deployment tool  38   b  can be translated through muscle (not shown), around nerves  72 , and anterior of the vertebral column  46 . The second deployment tool  38   b  can be steerable. The second deployment tool  38   b  can be steered, as shown by arrow  74 , to align the distal tip of the second expandable support device  2   b  with a second access port  64   b  on a second damage site  52   b . The second access port  64   b  can face anteriorly. The second deployment tool  38   b  can translate, as shown by arrow  76 , to position the second expandable support device  2  in the second damage site  52   b.    
     The vertebra  48  can have multiple damage sites  52  and expandable support devices  2  deployed therein. The expandable support devices  2  can be deployed from the anterior, posterior, either or both lateral, superior, inferior, any angle, or combinations of the directions thereof. 
       FIGS. 13 and 14  illustrate translating, as shown by arrow, the deployment tool  38  loaded with the expandable support device  2  through the access port  64 .  FIG. 15  illustrates locating the expandable support device  2  on the deployment tool  38  in the damage site  52 . 
       FIGS. 16 and 17  illustrate that the deployment tool  38  can be deployed from the posterior side of the vertebral column  46 . The deployment tool  38  can be deployed off-center, for example, when approaching the posterior side of the vertebral column  46 . 
       FIGS. 18 and 19  illustrate that first and second deployment tools  38   a  and  38   b  can position and deploy first and second expandable support devices  2   a  and  2   b  simultaneously, and/or in the same vertebra  48  and into the same or different damage sites  52   a  and  52   b.    
       FIG. 20  illustrates that the fluid pressure in the fluid conduit  42  and the balloon  44  can increase, thereby inflating the balloon  44 , as shown by arrows. The expandable support device  2  can expand, for example, due to pressure from the balloon  44 . The balloon  44  can be expanded until the expandable support device  2  is substantially fixed to the vertebra  48 . The balloon  44  and/or the expandable support device  2  can reshape the vertebral column  46  to a more natural configuration during expansion of the balloon  44 . 
       FIG. 21  illustrates that the access port  64  can be made close to the disc  50 , for example when the damage site  52  is close to the disc  50 . The deployment tool  38  can be inserted through the access port  64  and the expandable support device  2  can be deployed as described supra. 
       FIG. 22 , a front view of the vertebral column, illustrates that more than one expandable support device  2  can be deployed into a single vertebra  48 . For example, a first expandable support device (not shown) can be inserted through a first access port  64   a  and deployed in a first damage site  52   a , and a second expandable support device (not shown) can be inserted through a first access port  64   a  and deployed in a second damage site  52   b.    
     The first access port  64   a  can be substantially centered with respect to the first damage site  52   a . The first expandable support device (not shown) can expand, as shown by arrows  78 , substantially equidirectionally, aligned with the center of the first access port  64   a . The second access port  64   b  can be substantially not centered with respect to the second damage site  52   b . The second expandable support device (not shown) can substantially anchor to a side of the damage site  52  and/or the surface of the disc  50 , and then expand, as shown by arrows  80 , substantially directionally away from the disc  50 . 
       FIG. 23  illustrates that the fluid pressure can be released from the balloon  44 , and the balloon  44  can return to a pre-deployment configuration, leaving the expandable support element substantially fixed to the vertebra  48  at the damage site  52 . 
     The access port  64  can have an access port diameter  82 . The access port diameter  82  can be from about 1.5 mm (0.060 in.) to about 40 mm (2 in.), for example about 8 mm (0.3 in.). The access port diameter  82  can be a result of the size of the access tool  54 . After the expandable support device  2  is deployed, the damage site  52  can have a deployed diameter  84 . The deployed diameter  84  can be from about 1.5 mm (0.060 in.) to about 120 mm (4.7 in.), for example about 20 mm (0.8 in.). The deployed diameter  84  can be greater than, equal to, or less than the access port diameter  82 . 
       FIG. 24  illustrates that the deployment tool  38  can be removed, as shown by arrow, from the vertebra  48  after the expandable support device  2  is deployed. 
       FIGS. 25 and 26  illustrate the expandable support device  2  can be placed between the vertebral bodies into a defect  52  of the vertebral disc.  FIG. 25  illustrates an anterior approach to inserting the expandable support member between vertebral bodies.  FIG. 26  illustrates a posterior approach to inserting the expandable support member. The expandable support member can also be inserted from a lateral approach. 
     The expandable support device  2  can be configured to create a cavity or otherwise displaces bone and/or tissue to form a space within the target sites during deployment (e.g., during radial expansion). For example, the struts of the expandable support device  2  can be configured so the radial expansion of the expandable support device  2  can move and/or compact bone/tissue. The struts can be configured to be narrow such that, on expansion, the struts move a relatively smaller amount of bone and/or tissue such that the struts do not compact the tissue. 
     After the expandable support device  2  has been initially deployed (i.e., inserted, and/or radially expanded) into the treatment site, the expandable support device  2  can be retracted, removed, resized, repositioned, and combinations thereof. The expandable support device  2  can be retracted and/or removed, and/or resized, and/or repositioned, for example, about 0 to about 2 months after initial deployment and/or the latest removal, and/or resizing, and/or repositioning. 
       FIG. 27  illustrates that the deployment tool  38 , such as an engagement device, can be configured to attach to the implanted expandable support device. The engagement device can have one or more engagement elements  100 , such as first and second engagement elements  100   a  and  100   b . The engagement elements  100  can be on the radial inside and/or radial outside of the engagement device. For example, the engagement elements can be on an inner rod  102  that can be translatably and/or rotationally slidably attached to an outer handle  104 . The engagement elements  100  can be a screw thread, a keyed slot, a toggle, ball and socket, an interference fit, a clip, a ratchet, a magnet, glue, an expanding anchor clip, an abutment, a hook, or combinations thereof. The engagement device can be the deployment device (e.g., the deployment tool or other device originally used to deploy the expandable support device  2 ). 
       FIG. 27  illustrates that the engagement device  38  can attach to the expandable support device  2 . The expandable support device  2  can be configured to releasably attach to the engagement elements  100  at discrete locations (e.g., along discrete lengths of the inner diameter of the expandable support device  2 ). 
     The first engagement element  100   a  can attach to the proximal end of the expandable support device  2 . The first engagement element  100   a  can be an abutment. The second engagement element  100   b  can attach to the distal end of the expandable support device  2 . The second engagement element  100   b  can be a threaded outer surface. The expandable support device  2  can have a threaded inner radius, for example, that can be configured to engage the threaded outer surface of the second engagement element  100   b.    
       FIG. 28  illustrates that a tensile force, as shown by arrows  106 , can be applied to the ends of the expandable support device  2 , for example, via the engagement device  38  and the first and second engagement elements  100   a  and  100   b . For example, the inner rod  102  can be pushed distally while the outer handle  104  can be concurrently pulled proximally. The radius of the expandable support device  2  can contract, as shown by arrows  108 . 
       FIG. 29  illustrates that the tensile force, shown by arrows  106 , can longitudinally expand the expandable support device. The expandable support device can radially contract, for example, until the expandable support device  2  is in a configuration completely or substantially equivalent to the configuration of the expandable support device  2  before the original deployment of the expandable support device to the treatment site. For example, the expandable support device  2  can have a maximum outer radius that is equal to or smaller than the inner radius of the portion (e.g., the outer handle  104 ) of the deployment tool  38  into which the expandable support device  2  can be configured to retract. 
     The expandable support device  2  can be withdrawn from the target site, and/or retracted into the engagement device  38 . 
       FIG. 30  illustrates that the outer handle  104  can be a sheath and/or a sheath can be radially outside or inside of the outer handle  104 . The sheath can have a sheath entry  110 . The sheath entry  110  can be at the distal end of the sheath. The sheath entry  110  can have a hard material edge, and/or a slippery polymer edge, and/or a tapered edge, and/or an expanding slotted tube front edge, and/or a sacrificial (e.g., breakaway) edge. 
       FIG. 31  illustrates that the sheath can be forced over the expandable support device  2 , and/or the expandable support device  2  can be drawn, as shown by arrow  112 , into the sheath. 
       FIG. 31  illustrates that the expandable support device  2  can radially contract, as shown by arrows  114 , as the expandable support device  2  is completely or partially translated (e.g., withdrawn, retracted), as shown by arrow  112 , into the sheath. The radial contraction of the expandable support device  2  can be resilient or forced deformation. 
       FIG. 32  illustrates that the expandable support device  2  can be completely withdrawn or retracted into the sheath. In a radially contracted configuration, the outer radius of the expandable support device  2  can be about equal to and/or smaller than the inner radius of the sheath. The deployment tool  38  and expandable support device  2  can be removed from the target site. 
       FIG. 33  illustrates a side view of the engagement device  38  deployed through the expandable support device  2 . The engagement device  38  can be deployed extending through the expandable support device  2 , for example through a center channel or port. 
       FIG. 34  illustrates that the engagement device  38  can have an engagement element  100  that can be configured to unbuckle, tear, split, destroy, separate, cut, break or combinations thereof, the struts  10 . The engagement element  100  can be a cutter saw  116 , and/or otherwise have a bladed or sharp proximal side. 
       FIG. 35  illustrates that the engagement device  38  can be longitudinally translated, as shown by arrow, for example, drawing the engagement element  100  through the struts  10 . The engagement element  100  can unbuckle, tear, split, destroy, separate, cut, break or combinations thereof, the struts  10 . The engagement element  100  can partially or completely collapse or buckle the expandable support device  2 , for example within the target or treatment site (e.g., bone cavity). 
       FIGS. 36 a  and 36 b    illustrate that the expandable support device  2  can be separated into two or more expandable support device pieces  118 . The expandable support device pieces  118  can be removed and/or repositioned and/or resized individually and/or together from the target site. 
       FIG. 37  illustrates a cross-sectional view of a method of adjusting the expandable support device similar to the method illustrated in  FIGS. 27 through 29 . The first engagement element  100   a  can be threading on the radial inside of the outer handle. The first engagement element  100   a  can be forced toward the second engagement element  100   b  (e.g., by pushing the outer handle  104  distally and pulling the inner rod  102  proximally), for example to radially expand and longitudinally contract the expandable support device  2 . The first engagement element  100   a  can be forced away from the second engagement element  100   b  (e.g., by pulling the outer handle  104  proximally and pushing the inner rod  102  distally), for example to radially contract and longitudinally expand the expandable support device  2   
     The deployment tool  38  can be rotatably attached to and detached from the expandable support device  2 . The outer handle  104  can contact the expandable support device  2  by completely encircling the first engagement element  100   a , and/or by discretely contacting the first engagement element  100   a , for example with a set of individual radially translatable arms that can be detached from the first engagement element  100   a  by translating the arms radially outward (or inward if necessary) from the first engagement element  100   a.    
     The outer handle  104  and inner rod  102  can be detached and/or reattached in any combination to the expandable support device  2 . For example, the expandable support device  2  can be positioned in the target site. The expandable support device  2  can then be radially expanded (e.g., by applying a longitudinally compressive force). The inner rod  102  can then be detached from the expandable support device  2 . The expandable support device  2  can be repositioned by manipulating the expandable support device  2  with the outer handle  104 . The outer handle  104  can then be detached from the expandable support device  2  and the deployment tool can be withdrawn from the target site and/or the inner rod  102  can be reattached to the expandable support device  2  and the expandable support device can be radially expanded, and/or radially contracted, and/or repositioned within the target site, and/or removed from the target site. 
       FIG. 38  illustrates a cross section of the expandable support device  2  implanted at a treatment site  52  in a bone  48 . The expandable support device  2  can have one or more markers, such as a first marker  120   a  and/or a second marker  120   b , attach to and/or be integral with the expandable support device  2 . Any number of markers  120  can extend out of the bone  52 . The markers  120  can be radiopaque and/or echogenic. The markers  120  can be used, for example, to locate the expandable support device  2  (e.g., once the bone  48  has regrown around the treatment site  52 ). 
     The expandable support device  2  can be configured to radially contract when a rotational (e.g., twisting) force is applied to the expandable support device  2 . The expandable support device  2  can have a completely or partially coiled or otherwise spiral configuration. The expandable support device  2  can have a radius or height reduction based on a twisting effect. 
     The expandable support device  2  can be configured to be overdeployable. When the expandable support device  2  is overdeployed, the expandable support device  2  can return to a substantially pre-deployment configuration (e.g., having a pre-deployment radius, but in a different configuration otherwise). 
       FIGS. 39 through 41  illustrate that the configuration of the struts  10  can cause the expandable support device  2  to have an overdeployment radius substantially equivalent to a pre-deployment radius  122 .  FIG. 39  illustrates the expandable support device  2  in a pre-deployment configuration. A longitudinally compressive force, as shown by arrows  124 , can be applied. Radial expansion, as shown by arrows  126 , can begin, for example due to the longitudinally compressive force. 
       FIG. 40  illustrates that when the expandable support device  2  is fully deployed, the expandable support device  2  has no radial expansion. The longitudinally compressive forces, as shown by arrows  124 , can begin to force the struts longitudinally inward, for example beyond a configuration at the maximum radial expansion of the expandable support device  2 . This overdeployment can cause a decrease in the radius of the expandable support device  2 . 
       FIG. 41  illustrates that when the expandable support device  2  is overdeployed, the expandable support device  2  can radially contract, as shown by arrows  128 . The expandable support device  2  can have an overdeployment radius  130  substantially equivalent to, or less than, or greater than the pre-deployment radius  122 . 
       FIG. 42  illustrates that the expandable support device  2  can have a control element, such as internal control shaft  132 . The internal control shaft  132  can be removably attached to the inner rod  102 . The remainder of the expandable support element  2  can be removably and/or rotatably attached to the interenal control shaft  132 . 
     The internal control shaft  132  can have the first and second engagement elements  100   a  and  100   b . The expandable support element  2  can have discrete first and second receivers  136   a  and  136   b  configured to removably attach to the first and second engagement elements  100   a  and  100   b , respectively. For example, the first and second receivers  136   a  and  136   b  can be threaded. 
     The first engagement element  100   a  can have a stop or brake thread  140 , for example configured to interference fit the first receiver  136   a.    
     In an undeployed or pre-deployed (e.g., radially contracted) configuration, the second engagement element  100   b  can be attached to the second receiver  136   b . The first engagement element  100   a  can be unattached to the first receiver  136   a.    
       FIG. 43  illustrates that a compression force, shown by arrows  142 , can be applied to the expandable support device  2 . For example, the sliding rod  102  can be pulled proximally and the outside handle  104  can be pushed distally. The expandable support device  2  can be attached to the sliding rod  102  via the second engagement element  100   b  and the second receiver  136   b . The expandable support device  2  can be attached to the outside handle  104  via abutting or otherwise engaging at the first receiver  136   a  or other element. The compression force can produce radial expansion, as shown by arrows  144 , in the expandable support device  2 . 
       FIG. 44  illustrates that once the expandable support device  2  is substantially radial expanded, the inner rod can be rotated, as shown by arrow  146 , with respect to the expandable support device  2  with the exception of the inner control shaft  148 . (The expandable support device can be held rotationally stationary by the target site and/or by engagement between the outside handle and the expandable support device  2 .) The inner control shaft  132  can rotate as shown by arrow  148 . The rotation of the second engagement element  100   b  with respect to the second receiver  136   b  can force the control shaft  132  to translate, as shown by arrow  150 , with respect to the expandable support device  2 . The expandable support device  2  can radially expand during the translation shown by the arrow  150 . 
       FIG. 45  illustrates that during the translation shown by arrow  150  in  FIG. 44 , the first engagement element  100   a  can engage the first receiver  136   a . The second engagement element  100   b  can remain engaged to the second receiver  136   b . The inner rod  102 , control shaft  132 , and first engagement element  136   a  can rotate with respect to the remainder of the expandable support device  2 , for example until a safety element, such as the brake thread  140 , stops the rotation. The brake thread  140  can interference fit with the first receiver  136   a . The brake thread  140  can provide sufficient resistance to friction fit with the first receiver  136   a . The safety element (e.g., stop or brake thread) can be on the first and/or second engagement elements  100   a  and/or  100   b  and/or first and/or second receivers  136   a  and/or  136   b.    
       FIG. 46  illustrates that the inner control shaft  132  can be detached from the inner rod  102 , for example at a coupling point  152 . The coupling point  152  can include one or more detachable attachment elements, such as hooks, pegs and holes, thread knots and holes, radially translatable arms, teeth, threads, or combinations thereof. The inner control shaft  132  can have corresponding detachable attachment elements, such as threads  154 . The threads can be in the same direction (e.g., with higher coefficients of friction) as the threads of the first and second engagement elements  100   a  and  100   b , or counter-threaded with respect to the threads of the first and second engagement elements  100   a  and  100   b . The coupling point  152  can be detached by deactivating or otherwise detaching the detachable attachment elements. For example, the inner rod  102  can be rotated or counter rotated as necessary, as shown by arrow. The inner control shaft  132  can remain rotationally fixed because, for example, the target site has substantially fixed the expandable support device and the brake thread  140  can fix the inner control shaft  132  to the expandable support device  2 . 
     The deployment tool  38  can be removed from the target site. The expandable support device  2  can remain in the target site, for example, fixed in the deployed configuration (e.g., unable to substantially radially or longitudinally expand or contract) and/or bolstered by the inner control shaft  132 . The deployment tool  38  can re-engage the expandable support device  2  and the above steps can be reversed to radially contract and retract, reposition, and/or remove the expandable support device  2  in or from the target site. 
     The expandable support device  2  can have a mechanical key or locking bar that can fix the expandable support device  2  in an expanded or otherwise deployed configuration. When the key or locking bar is removed from the expandable support device  2 , the expandable support device  2  can be repositioned, and/or removed and/or resized (e.g., deconstructed), for example, automatically, resiliently radially compressed. 
     The expandable support device can be subject to fatigue, for example, to increase material brittleness resulting in fracture. The fractured pieces of the expandable support device can be removed, for example, by suction and irrigation. The engagement element can be a small grabber or gripper. The engagement element can induce oscillating motion in the struts. The oscillating motion can cause strut fatigue and failure, for example in the struts and/or in the joints. The oscillating motion can be ultrasonic, mechanical, hydraulic, pneumatic, or combinations thereof. 
     The expandable support device  2  can have receiving elements to engage the engagement elements. For example, the receiving elements can be hooks, barbs, threads, flanges, wedge shaped slots, dovetails, hinges, key holes, or combinations thereof. 
     The expandable support device  2  can have a leader. The leader can be a heavy wire. The leader can guide the engagement device into and/or over the implant. The engagement device  38  can radially contract the implant, for example, using a method described herein. The engagement device  38  and/or another tool can drill or otherwise destroy bone and/or other tissue to access the expandable support device  2 . 
     The tissue surrounding the expandable support device  2  can be destroyed (e.g., chemically and/or electrically and/or thermally, such as by cauterization or electro-cauterization). The expandable support device  2  can be removed and/or repositioned and/or resized once the surrounding tissue is completely or substantially destroyed. 
     The expandable support device  2  can be mechanically destroyed. For example, the expandable support device can be mechanically compressed, for example by applying external radially and/or axially (i.e., longitudinally) contracting jaws. A snipper and/or microgrinder and/or saw can mechanically destroy the expandable support device. 
     The expandable support device  2  can be chemically destroyed using RF energy. For example UV energy can be delivered to dissolve a plastic expandable support device. 
     The expandable support device  2  can be biodegradable. The expandable support device  2  can be made from biodegradable materials known to those having ordinary skill in the art. The expandable support device  2  can be made from a magnesium based alloy that can degrade or a biodegrading polymer for example, PGA, PLA, PLLA, PCL. 
     The expandable support device  2  can be configured to device designed to dissolve when exposed to selected materials (e.g., in solution). For example, acetone can be applied to the expandable support device (e.g., made from PMMA). The surrounding tissues can be protected and/or the expandable support device can be fluidly contained before the dissolving solution is applied. 
     The expandable support device  2  can be dissolved, for example, by exposing the expandable support device to an electrolyte and electricity. 
     Imaging methods can be used in combination with the methods for deploying the expandable support device described herein. For example, imaging methods can be used to guide the expandable support device during deployment. The expandable support device  2  can have imaging markers (e.g., echogenic, radiopaque), for example to signal the three-dimensinal orientation and location of the expandable support device during use of an imaging modality. Imaging modalities include ultrasound, magnetic resonance imaging (MRI, fMRI), computer tomography (CT scans) and computed axial tomography (CAT scans), radiographs (x-rays), fluoroscopy, diffuse optical tomography, elastography, electrical impedance tomography, optoacoustic imaging, positron emission tomography, and combinations thereof. 
     It is apparent to one skilled in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the spirit and scope of the invention. Elements expressed herein as singular or plural can be used in the alternative (i.e., singular as plural and plural as singular). Elements shown with any embodiment are exemplary for the specific embodiment and can be used in combination on or with other embodiments within this disclosure.