Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation application of U.S. patent application Ser. No. 12/260,971, filed Oct. 29, 2008, which is a continuation-in-part of PCT International Application No. PCT/US2007/067967, filed May 1, 2007, which claims the benefit of U.S. Provisional Application No. 60/796,915, filed May 1, 2006, each of which is herein incorporated by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
       [0002]    This invention relates to devices for providing support for biological tissue, for example to repair spinal compression fractures, and methods of using the same. 
       BRIEF SUMMARY OF THE INVENTION 
       [0003]    An expandable support device for performing completely or partially implantable spinal repair is disclosed. The device has a first strut and a second strut attached to, and/or integral with, the first strut. The first strut is substantially deformable. The second strut can be substantially inflexible. 
         [0004]    The device can be configured to expand in a radial direction during deployment in a bone. The device can be configured to contract in a longitudinal direction during deployment in a bone. 
         [0005]    An expandable support device for repairing damaged bone is disclosed. The expandable support device can have a longitudinal axis. The expandable support device can have a first strut having a first strut cross-section. The expandable support device can have a second strut attached to, and/or integral with, the first strut. The first strut can be substantially deformable. The first strut cross-section can be configured to encourage bone growth toward the longitudinal axis. 
         [0006]    The expandable support device can have a bone growth material. The first strut can have the bone growth material. The first strut can be coated with the bone growth material. The bone growth material can circumferentially surround the first strut cross-section. 
         [0007]    The first strut can have a first strut first side closer to the longitudinal axis and a first strut second side farther from the longitudinal axis than the first strut first side, and the bone growth material can be on the first strut first side. The first strut second side can be substantially uncoated with the bone growth material. 
         [0008]    The first strut cross-section can have a needle tip. The first strut cross-section can have a chisel tip. The first strut can have a thread extending radially therefrom. The first strut can have a longitudinal vane extending radially therefrom. 
         [0009]    An apparatus for deploying and retrieving an expandable support device is a bone is disclosed. The apparatus can have a deployment rod. The deployment rod can have an expandable support device engager. The apparatus can have a retrieval sheath translatably slidable with respect to the deployment rod. The retrieval sheath can be configured to radially compress the expandable support device. 
         [0010]    A method of retrieving a deployed expandable support device from a bone is disclosed. The method can include holding the expandable support device. The method can include translating a sheath over the expandable support device. Translating the sheath can include translating a rigid sheath. Holding can include holding a first end of the expandable support device. Translating can include radially compressing the expandable support device. The method can include translating the expandable support device out of the bone. 
         [0011]    A method of deploying an expandable support device having a radius in a bone is disclosed. The method can include positioning the expandable support device in the bone. The method can also include radially expanding the expandable support device through the bone. The method can also include creating track voids. The method can also include deploying a material into the track voids, wherein the material encourages bone growth. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  is a perspective view of a variation of the expandable support device in a radially expanded configuration. 
           [0013]      FIG. 2  is a side view of a variation of the expandable support device in a radially compressed configuration. 
           [0014]      FIG. 3  is a rear view of the variation of the expandable support device of  FIG. 2  in a radially compressed configuration. 
           [0015]      FIG. 4  is a perspective view of the variation of the expandable support device of  FIG. 2  in a radially compressed configuration. 
           [0016]      FIG. 5  is a close-up view of section AA of  FIG. 2 . 
           [0017]      FIG. 6  is a close-up view of section AB of  FIG. 2 . 
           [0018]      FIG. 7  illustrates a variation of the expandable support device in a radially contracted configuration. 
           [0019]      FIG. 8  illustrates a variation of a cell of the expandable support device of  FIG. 7 . 
           [0020]      FIG. 9  illustrates a variation of the expandable support device in a radially expanded configuration. 
           [0021]      FIG. 10  illustrates a variation of a cell of the expandable support device of  FIG. 9 . 
           [0022]      FIGS. 11-13  illustrate cross section B-B of various variations of the expandable support device. 
           [0023]      FIG. 14  illustrates cross-section C-C of the variation of the expandable support device in  FIG. 13 . 
           [0024]      FIG. 15  is a side view of a variation of the distal attachment element. 
           [0025]      FIG. 16  is a front view of a variation of the distal attachment element. 
           [0026]      FIG. 17  illustrates a variation of cross-section AC-AC of  FIG. 15 . 
           [0027]      FIG. 18  is a perspective view of a variation of cross-section AC-AC of  FIG. 15 . 
           [0028]      FIG. 19  is a side view of a variation of the proximal attachment element. 
           [0029]      FIG. 20  is a rear view of a variation of the proximal attachment element. 
           [0030]      FIG. 21  illustrates a variation of cross-section AD-AD of  FIG. 19 . 
           [0031]      FIG. 22  is a perspective view of a variation of cross-section AD-AD of  FIG. 19 . 
           [0032]      FIGS. 23 through 38  illustrate various variations of section A-A of  FIG. 9 . 
           [0033]      FIG. 39  illustrates various methods for deploying the expandable support device. 
           [0034]      FIG. 40  illustrates a variation of a method of deploying the expandable support device with a deployment tool. 
           [0035]      FIG. 41  illustrates the variation of  FIG. 40  with the deployment tool in a partially disassembled configuration. 
           [0036]      FIGS. 42 and 43  illustrate cross-section D-D of a variation of a method for radially expanding the expandable support device of  FIG. 40 . 
           [0037]      FIGS. 44 through 46  illustrate a variation of the method of retrieving the expandable support device. 
           [0038]      FIG. 47  illustrates a variation of the deployment tool with the expandable support device removed from the vertebra. 
           [0039]      FIGS. 40, 41, and 44 through 47  illustrate the vertebra with a partial ventral sagittal cut-away for illustrative purposes. 
           [0040]      FIGS. 48 through 52  illustrate longitudinal cross-sectional views (similar to sectional view D-D) of a variation for the deployment and recovery of a variation of the expandable support device. 
           [0041]      FIG. 53  illustrates a variation of the expandable support device loaded on a variation of the deployment tool. 
           [0042]      FIG. 54  illustrate cross-sections E-E and F-F of the deployment rod and expandable support device, respectively, of  FIG. 53  in aligned unlocked configurations. 
           [0043]      FIG. 55  illustrate cross-sections E-E and F-F of the deployment rod and expandable support device, respectively, of  FIG. 53  in aligned locked configurations. 
           [0044]      FIGS. 56 and 57  illustrate variations of explants of the expandable support device with bone. 
           [0045]      FIG. 58  is a close-up view of section H of  FIG. 56 . 
           [0046]      FIGS. 59 through 61  illustrate various variations of cross-section G-G of  FIG. 57 . 
           [0047]      FIGS. 1, 40, 51, 45, 47, 56 and 57 , are shown with exemplary length scales labeled in 10 mm increments and tabbed in ½ mm and 1 mm increments. 
       
    
    
       [0048]    Dimensions shown in  FIGS. 15, 16, 17, 19 and 21  are merely examples. All dimensions can be from about 25% to about 400% of the dimensions shown in the figures, more narrowly from about 75% to about 125% of the dimensions shown in the figures. 
       DETAILED DESCRIPTION 
       [0049]      FIG. 1  illustrates an expandable support device  2  in a radially expanded and longitudinally contracted configuration. The expandable support device  2  can be configured to be deployed in a treatment site, such as a bone, to provide mechanical support, for example to treat compression or other fractures or other structural bone failures. The expandable support device  2  can have a radially contracted and longitudinally expanded configuration, for example before deployment into a treatment site. The expandable support device  2  can have a radially expanded and longitudinally contracted configuration, for example after deployment into the treatment site. 
         [0050]    The expandable support device  2  can have a longitudinal axis  4 . The expandable support device  2  can have a distal port  6  at a longitudinally distal end and a proximal port  8  at a longitudinally proximal end. The expandable support device  2  can have a device radial side  10 . The device side  10  can be substantially the surface defined by the cells  12  and pores  14 , and for example, can exclude the proximal port  8  and the distal port  6 . 
         [0051]    The expandable support device  2  can have a number of struts  16  connected at joints  18 . The struts  16  can be rigid and/or flexible. The struts  16  can be deformable and/or resilient. The joints  18  can be rigid and/or flexible. The joints  18  can be deformable and/or resilient. 
         [0052]    The struts  16  and joints  18  can form enclosed shapes, such as cells  12 . The cell  12  can dynamically act as a four-bar system (e.g., if the cell has four struts), five-bar system (e.g., if the cell has five struts), or another closed dynamic system correlating with the number of struts  16  and joints  18  of the cell. 
         [0053]    The interior area of each cell can be a pore  14 . The pores  14  can be open to the radial center of the expandable support device  2 . The pores  14  can be substantially unobstructed. The pores  14  can encourage tissue (e.g., bone) growth toward the lumen or longitudinal channel of the expandable support device  2 . 
         [0054]    The device side can have a device side area  10 . The radially (e.g., with respect to the longitudinal axis) external area joints  18  and struts  16  can be a solid surface area. The radially (e.g., with respect to the longitudinal axis) external area of the pores  14  can be a pore area. The ratio of the pore area to the device side area can be a pore ratio. With the expandable support device  2  in a radially expanded configuration, the pore ratio can be from about 20% to about 99%, more narrowly from about 50% to about 98%, yet more narrowly from about 75% to about 95%, for example about 80% or about 85% or about 90%. 
         [0055]    Additional exemplary variations, features, elements and methods of use of the expandable support device and tools for deploying the expandable support device are described in PCT Patent Application Serial Numbers PCT/US05/034115 filed 21 Sep. 2005; PCT/US05/034742 filed 27 Sep. 2005; PCT/US05/034728 filed 27 Sep. 2005; PCT/US2005/037126 filed 12 Oct. 2005; and U.S. Provisional Patent Application Nos. 60/675,543 filed 27 Apr. 2005; 60/741,201 filed 1 Dec. 2005; 60/741,197 filed 1 Dec. 2005; 60/751,882 filed 19 Dec. 2005; 60/675,512 filed 27 Apr. 2005; 60/752,180 filed 19 Dec. 2005; 60/699,577 filed 14 Jul. 2005; 60/699,576 filed 14 Jul. 2005; 60/754,492 filed 28 Dec. 2005; 60/751,390 filed 15 Dec. 2005; 60/752,186 filed 19 Dec. 2005; 60/754,377 filed 27 Dec. 2005; 60/754,227 filed 28 Dec. 2005; 60/752,185 filed 19 Dec. 2005; and 60/752,182 filed 19 Dec. 2005; all of which are incorporated by reference herein in their entireties. 
         [0056]      FIGS. 2, 3 and 4  illustrate that a distal end of the expandable support device  2  can be attached to and/or integral with a distal releasable attachment element  20 . The proximal end of the expandable support device  2  can be attached to and/or integral with a proximal releasable attachment element  22 . 
         [0057]      FIG. 5  illustrates that the distal releasable attachment element  20  can be fixedly or removably attached to the expandable support device  2  at one or more attachment points  24 . The attachment points  24  can be welds, press fits, adhesive, integrated elements, or combinations thereof. 
         [0058]      FIG. 6  illustrates that the proximal releasable attachment element  22  can be fixedly or removably attached to the expandable support device  2  at one or more attachment points  24 . The proximal releasable attachment element  22  can have a varying outer diameter along its length. The outer diameter of the proximal releasable attachment element  22  act as an interface, for example to be engaged by a deployment tool. 
         [0059]      FIG. 7  illustrates that the expandable support device  2  can have a radially contracted configuration. The expandable support device  2  can have a contracted diameter  26  and an expanded length  28 . The expandable support device  2  can have a substantially cylindrical shape. 
         [0060]      FIG. 8  illustrates that the cell  12  can have at least one longitudinal cell angle  30 . The longitudinal cell angle  30  can be the angle formed between a first strut  32  and a second strut  34 . The longitudinal cell angle  30  can face in a substantially parallel, or otherwise aligned, direction to the longitudinal axis  4 . 
         [0061]    The cell  12  can have at least one transverse cell angle  36 . The transverse cell angle  36  can be the angle formed between the first strut  32  and a third strut  38 . The transverse cell angle  36  can face in a substantially perpendicular or otherwise misaligned direction to the longitudinal axis  4 . The transverse cell angle  36  can face in a substantially perpendicular or otherwise misaligned direction to the longitudinal cell angle  30 . 
         [0062]      FIG. 9  illustrates that the expandable support device  2  can have a radially expanded configuration. The expandable support device  2  can have an expanded diameter  40  and a contracted length  42 . The expanded diameter  2  can be greater than the contracted diameter  26 . The contracted length  42  can be less than the expanded length  28 . The expandable support device  2  can have a substantially spherical, toroid or cubical shape. 
         [0063]      FIG. 10  illustrates that transverse cell angle  36  in the cell  12  from the expandable support device  2  having the radially expanded configuration can be smaller than the cell angle  36  in the cell from the expandable support device  2  having the radially contracted configuration. The longitudinal cell angle  30  in the cell  12  from the expandable support device  2  having the radially expanded configuration can be larger than the cell angle  36  in the cell  12  from the expandable support device  2  having the radially contracted configuration. 
         [0064]      FIG. 11  illustrates that the expandable support device  2  can have releasable attachment elements at the distal and/or proximal ends. For example, the expandable support device  2  can have distal device threads  44  and/or proximal device threads  46 . The device mid-length section  48  can be bare of threads. The releasable attachment elements can be controllably removably attached to a deployment tool and/or the remainder of the expandable support device  2 . 
         [0065]      FIG. 12  illustrates that the device threads  50  can be continuous and/or substantially continuous from the proximal to the distal end (i.e., including the device mid-length section  48 ) of the expandable support device  2 . 
         [0066]      FIGS. 13 and 14  illustrates that the releasable attachment element, such as the proximal releasable attachment element  22 , can be one or more device keys  52 . The device keys  52  can have device key distal ends  54 . The device key distal ends  54  can protrude in the distal direction and, for example can be sharpened. Device key ports  56  can be angularly between the device keys  52 . The releasable attachment devices can be threads, keys, tabs, luers, or combinations thereof. 
         [0067]      FIGS. 15, 16, 17 and 18  illustrate that the distal releasable attachment element  20  can have an internal channel  58 . The internal channel  58  can have an internal channel diameter  59 . The internal channel diameter  59  can be from about 1 mm (0.4 in.) to about 3 mm (0.1 in.), for example about 1.99 mm (0.0785 in.) 
         [0068]    The distal releasable attachment element  20  can have distal device threads  44  (shown in  FIG. 18 ). 
         [0069]    The distal releasable attachment element  20  can have a sharpened distal end. The sharpened distal end can be used, for example, to push through bone during use. The sharpened distal end can have a sharpened distal end angle  61 . The sharpened distal end angle  61  can be from about 20° to about 70°, for example about 45°. 
         [0070]    The distal releasable attachment element  20  can have a distal releasable attachment element length  63 . The distal releasable attachment element length  63  can be from about 13 mm (0.051 in.) to about 5 mm (0.2 in.), for example about 2.92 mm (0.115 in.). 
         [0071]    The distal releasable attachment element  20  can have a distal releasable attachment element outer diameter  65 . The distal releasable attachment outer diameter  65  can be from about 2.5 mm (0.098 in.) to about 10 mm (0.4 in.), for example about 4.78 mm (0.188 in.). 
         [0072]    The distal releasable attachment element  20  can have an inner chamfer  67 . The inner chamfer  67  can have an angle of about 45° from the adjacent sides and can have a length of about 0.2 mm (0.009 in.). 
         [0073]      FIGS. 19, 20, 21 and 22  illustrate that the proximal releasable attachment element  22  can have the internal channel  58 . The distal releasable attachment element  20  can have distal device threads  44  (shown in  FIG. 18 ). The distal releasable attachment element  20  can have an engagable (e.g., lipped or notched) proximal end. The engagable proximal end can be configured, for example, to releasably engage a deployment tool. 
         [0074]      FIG. 23  illustrates that the struts  16  can define a circular or oval cross-section of the expandable support device  2  in a given cross-section A-A. The pores  14  can have pore angles  60  with respect to the longitudinal axis  4  in cross-section, as shown. The pore angles  60  can vary around the cross-section of the expandable support device  2  (i.e., as the pores get closer to distal and proximal joints, the pore angles approach zero). The struts  16  can have uniform (as shown) or various cross-sectional configurations. The struts  16  can have substantially circular cross-sections, as shown in  FIG. 10 . 
         [0075]      FIG. 24  illustrates that the struts  16  can form a square or rectangular cross-section of the expandable support device  2  in a given cross-section A-A. One or more of the struts  16  can have markers  62 , such as radiopaque and/or echogenic markers. The markers  62  can be unique for each strut  16 . For example, the markers  62  can identify the deployment orientation, as shown (e.g., arrows pointing in the up direction for deployment, with the top strut&#39;s marker showing a top arrow; the left strut&#39;s marker showing an arrow with only a left arrow-end; the right strut&#39;s marker showing an arrow with only a left arrow-end; and the bottom strut&#39;s marker showing an arrow with the arrowhead near the bottom of the arrow). 
         [0076]      FIG. 25  illustrates that the struts  16  can have substantially square or rectangular cross-sectional configurations. The struts  16  and joints  14  (not shown, and understood to be substantially represented when describing the struts in cross-sections A-A) can have first rectilinear axes  64 . The first rectilinear axes  64  can substantially or completely intersect the longitudinal axis  4  in a given cross-section A-A. Expandable support devices  2  that do not have circular or ovular transverse cross-sections (i.e., the shapes defined by the struts and pores shown in cross-section A-A), such as square, rectangular, triangular transverse cross-sections, or combinations thereof, can have one or more struts  16  with rectilinear axes  64  that do not substantially intersect the longitudinal axis  4  in a given cross-section A-A. 
         [0077]      FIG. 26  illustrates that the struts  16  and joints  14  (not shown) can have diametric or diagonal axes  66  in a given cross-section A-A. The diametric or diagonal axes  66  can substantially or completely intersect the longitudinal axis  4 . Expandable support devices  2  that do not have circular or ovular transverse cross-sections (i.e., the shapes defined by the struts and pores shown in cross-section A-A), such as square, rectangular, triangular transverse cross-sections, or combinations thereof, can have one or more struts  16  with diametric or diagonal axes  66  that do not substantially intersect the longitudinal axis  4  in a given cross-section A-A. The struts  16  can have square or rectangular cross-sectional configurations. 
         [0078]      FIG. 27  illustrates that the struts  16  and joints  14  (not shown) can have rectangular or oval (as shown) cross-sectional configurations or other cross-sectional configurations with primary and secondary axes. The oval cross-sections can each have a major (i.e., primary) axis  68 . The oval cross-sections can each have a minor (i.e., secondary) axis  70  in a given cross-section A-A. The major axes  68  can substantially or completely intersect the longitudinal axis  4 . The minor axes  70  can substantially or completely intersect the longitudinal axis  4 . Expandable support devices  2  that do not have circular or ovular transverse cross-sections (i.e., the shapes defined by the struts and pores shown in cross-section A-A), such as square, rectangular, triangular transverse cross-sections, or combinations thereof, can have one or more struts  16  with major  68  and/or minor axes  70  that do not substantially traverse the longitudinal axis  4  in a given cross-section A-A. 
         [0079]      FIG. 28  illustrates that the struts  16  and joints  14  (not shown) can have triangular (e.g., diagonal, right, isosceles, equilateral) cross-sectional configurations. The triangular configurations can each have the major axis  68 . 
         [0080]      FIG. 29  illustrates that the struts  16  and joints  14  (not shown) can have needle tips  72 , for example with a triangular configuration cross-sectional configuration. The needle tip  72  can have a first needle side  74  and a second needle side  76 . One or both needle sides can be concave inward. The needle tip  72  can have a needle tip angle from about 0.1° to about 30°, more narrowly from about 0.5° to about 25°, yet more narrowly from about 2° to about 20°, for example about 5° or about 10° or about 15°. 
         [0081]      FIG. 30  illustrates that the struts  16  and joints  14  (not shown) can each have a first needle tip  78  pointed radially outward, and a second needle tip  80  pointed radially inward. The major axis  68  can be the major axis for the first and second needle tips  78 ,  80 . 
         [0082]      FIG. 31  illustrates that the struts  16  and joints  14  (not shown) can have a first tip  82  and a second tip  84  along the major axis  68 . The struts  16  can be of nominal or otherwise substantially no thickness in directions other than the major axis  68 . 
         [0083]      FIG. 32  illustrates that the struts  16  and joints  14  (not shown) can have a nail-like configuration. The struts  16  can have a tip  86  running on the major axis  68 . The struts  16  can have a head  88 , for example, at about a 90° angle to the tip  86  and/or to the major axis  68 . 
         [0084]      FIG. 33  illustrates that the struts  16  and joints  14  (not shown) can have chisel tips  90 . The struts  16  can have quadrilateral (e.g., bicentric quadrilateral, cyclic quadrilateral, orthocentric quadrilateral, rational quadrilateral), parallelogram (e.g., medial parallelogram), rhombus (e.g., golden rhombus), kite, lozenge, trapezoid (e.g., isosceles trapezoid), tetrahedron cross-sectional configuration or combinations thereof. 
         [0085]      FIG. 34  illustrates that the struts  16  and joints  14  (not shown) can have randomly-shaped surface  92  configurations. The randomly-shaped surface  92  configurations can have an irregular surface defined by a random or quasi-random configuration. 
         [0086]      FIG. 35  illustrates that the struts  16  can have a textured (e.g., non-randomly surfaced) surface  94  configuration. For example, the textured surface  94  configuration can have a knurled, convex or concave dimpled or bumped, transversely and/or longitudinally and/or diagonally checkered or grooved (as shown), or brushed configuration, or combinations thereof. 
         [0087]      FIG. 36  illustrates that the struts  16  can each have one or more threads and/or longitudinal vanes  96  attached to or integral therewith. The threads and/or vanes  96  can extend radially toward the longitudinal axis  4 . The threads and/or vanes  96  can have a coating or be made partially or completely from any material listed herein, such as cements and/or fillers and/or glues (e.g., bone morphogenic protein, morselized bone, additional examples listed infra), such as for soliciting or otherwise encouraging bone growth. The threads and/or vanes  96  can be flexible or rigid. The threads and/or vanes  96  can be resilient and/or deformable. The threads and/or vanes  96  can be made in whole or part from a bioresorbable, bioabsorbable or biodegradable material. The various threads and/or vanes  96  can have uniform or variable lengths. 
         [0088]      FIG. 37  illustrates that the struts  16  can be wholly (as shown) or partially coated and/or otherwise covered by a coating and/or matrix  98  of any material listed herein.  FIG. 38  illustrates that the struts  16  can be coated and/or be otherwise covered by a material listed herein on the side of the strut  16  facing the longitudinal axis  4 . The side of the strut  16  not facing the longitudinal axis  4  can have no coating neither/nor be otherwise covered by a material other than the material of the original non-coated/covered strut. 
         [0089]    Any or all elements of the expandable support device  2  and/or deployment tool and/or other devices or apparatuses described herein 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. 
         [0090]    Any or all elements of the expandable support device  2  and/or deployment tool and/or other devices or apparatuses described herein, 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. 
         [0091]    The expandable support device  2  and/or deployment tool and/or elements of the expandable support device  2  and/or elements of the deployment tool and/or other devices or apparatuses described herein 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. 
         [0092]    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. 
         [0093]    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 
       [0094]      FIG. 39  illustrates that a first deployment tool  100  can enter through the subject&#39;s back. The first deployment tool  100  can enter through a first incision  102  in skin  104  on the posterior side of the subject near the vertebral column  106 . The first deployment tool  100  can be translated, as shown by arrow  108 , to position a first expandable support device  110  into a first damage site  112 . The first access port  114  can be on the posterior side of the vertebra  116 . 
         [0095]    A second deployment tool  118  can enter through a second incision  120  (as shown) in the skin  104  on the posterior or the first incision  102 . The second deployment tool  118  can be translated through muscle (not shown), around nerves  122 , and anterior of the vertebral column  106 . The second deployment tool  118  can be steerable. The second deployment tool  118  can be steered, as shown by arrow  124 , to align the distal tip of the second expandable support device  126  with a second access port  128  on a second damage site  130 . The second access port  128  can face anteriorly. The second deployment tool  118  can translate, as shown by arrow  132 , to position the second expandable support device  126  in the second damage site  130 . 
         [0096]    The vertebra  116  can have multiple damage sites  112 ,  130  and expandable support devices  2  deployed therein. The expandable support devices  2  can be deployed from the anterior, posterior, both lateral, superior, inferior, any angle, or combinations of the directions thereof. 
         [0097]    As shown in applications incorporated by reference herein, the expandable support device  2  can be inserted in the vertebra  116  in a radially contracted configuration. The expandable support device  2  can then be radially expanded. 
         [0098]      FIG. 40  illustrates the expandable support device  2  in a partially deployed, radially expanded configuration in the vertebra  116 . The expandable support device  2  can be removably attached to the deployment tool  134 . The deployment tool  134  can have a deployment rod sheath  136 , as shown. The expandable support device  2  can be attached to a deployment rod and/or the deployment rod sheath  136 . 
         [0099]      FIG. 41  illustrates  FIG. 40  with the deployment tool  134  partially disassembled for illustrative purposes. The deployment tool  134  can have a recovery sheath  138 . The recovery sheath  138  can be slidably attached over the deployment rod and/or the deployment rod sheath  136 . The recovery sheath  138  can be hollow cylinder. The recovery sheath  138  can be translatably controlled by the deployment tool  134 . The deployment rod sheath  136  can be slidably or fixedly attached to the deployment rod and/or the remainder of the deployment tool  134 . 
         [0100]      FIG. 42  illustrates that a deployment tool  134  can have a distal tool head  140  at the distal end of a distal tool shaft  142 . The distal tool shaft  142  can be removably attached to the distal end of the expandable support device  2  (e.g., interference fit and/or threadably attached). The deployment tool  134  can have an engagement element  144  that can be removably attached (e.g., threadably attached and/or interference fit) to the proximal end of the expandable support device  2 . For example, one or more struts  16  at the proximal end of the expandable support device  2  can be releasably compressed between the engagement element  144  and a proximal anvil  146  that can be attached to or integral with the deployment rod  148 . 
         [0101]    The distal tool shaft  142  can be translated proximally, as shown by arrow  150 . The distal tool head  140  and the proximal anvil  146  can longitudinally compress, as shown by arrow  152 , the expandable support device  2 . The expandable support device  2  can then radially expand, as shown by arrow  154 . 
         [0102]      FIG. 43  illustrates that the distal tool head  140  can be removably attached (e.g., unscrewable, or unlockable—as a key, or retractable (e.g., rotatably, or otherwise compressably or condensably)) attached to the distal tool shaft  142 . The distal tool head  140  can be retracted and the distal tool shaft  142  can be translated out of the expandable support device, as shown by arrow  150 . 
         [0103]      FIGS. 44 and 45  illustrate that the expandable support device  2  can be in a radially expanded configuration in the vertebra. The expandable support device  2  can be attached to the deployment tool  134  (e.g., never released during deployment or released and re-attached/re-engaged). The expandable support device  2  can be in an incorrect location, improperly radially expanded, or otherwise desirous of being removed, repositioned, or otherwise redeployed. The recovery sheath  138  can be translated, as shown by arrow  156 , toward and onto the expandable support device  2 . The expandable support device  2 , substantially other than the recovery sheath  138 , can be substantially stationary with respect to the expandable support device  2 . The recovery sheath  138  can begin to radial compress, as shown by arrows  158 , the expandable support device  2 . 
         [0104]      FIG. 46  illustrates that the recovery sheath  138  can be additionally translated, as shown by arrow  156 , over the expandable support device  2 . The expandable support device  2  can radially contract, as shown by arrows  158 , for example into a substantially radially contracted configuration. The deployment tool  134  can then by translated, as shown by arrow  160 , away from the vertebra  116 . The deployment tool  134  can reposition the expandable support device  2  and retract the recovery sheath  138 , and for example radially expand the expandable support device  2  in the vertebra  116  (e.g., with or without removing the expandable support device from the vertebra). 
         [0105]      FIG. 47  illustrates that the deployment tool  134  can completely remove the expandable support device  2  from the vertebra  116 . The same or a different expandable support device  2  can then be deployed into the vertebra  116 . 
         [0106]      FIG. 48  illustrates that the expandable support device  2  can be releasably attached to the deployment tool  134 . The deployment tool  134  can have the deployment rod  148  extending from the deployment rod sheath  136 . The deployment tool  148  can have distal rod threads  162 . The distal rod threads  162  can be releasably (e.g., rotatably) attached to the distal device threads  44 . The deployment rod  148  can have proximal rod threads  164  between the distal rod threads  162  and the proximal device threads  46 . The deployment tool  134  can have a deployment rod sheath  136 . The deployment rod sheath  136  can abut, interference fit or otherwise attach to the proximal end of the expandable support device  2 . 
         [0107]      FIG. 49  illustrates that the deployment rod  148  can be forcibly proximally translated, as shown by arrow  166 . The expandable support device  2  can then be longitudinally compressed, as shown by arrow  168 , between the distal device threads  44  and the deployment rod sheath  136  and/or other proximal attachment device (not shown). The expandable support device  2  can radially expand, as shown by arrows  170 , for example due to the longitudinal compression  152 . 
         [0108]      FIG. 50  illustrates that, with the expandable support device  2  in a radially expanded configuration, the deployment rod  148  can be proximally translated, as shown by arrow  166 . The translation of the deployment rod can, for example, be due to rotation of the deployment rod  148 , as shown by arrow  172 , and the threading of distal rod threads  162  through the distal device threads  44 . 
         [0109]    The proximal rod threads  164  can thread into the proximal device threads  46 . If the placement and configuration of the expandable support device  2  is satisfactory, the proximal rod threads  164  can be rotatably removed from the proximal device threads  46 . The deployment device can then be removed entirely. If the placement and configuration of the expandable support device  2  is not satisfactory, the expandable support device  2  can be radially contracted and removed from the treatment site, as described infra. 
         [0110]      FIG. 51  illustrates that the recovery sheath  138  can be translated, as shown by arrow  156 , toward the expandable support device  2 , and/or the expandable support device  2  can be translated (e.g., via translation of the attached deployment rod  148 ) toward the recovery sheath  138 . 
         [0111]      FIG. 52  illustrates that the recovery sheath  138  can be translated onto the expandable support device  2 , as shown by arrow  171 , and/or the expandable support device  2  (e.g., via translation of the attached deployment rod  148 ) can be translated, as shown by arrow  173 , into the recovery sheath  138  and/or the expandable support device  2  can be translated toward the recovery sheath  138 . As the expandable support device  2  is translated into the recovery sheath  138 , the expandable support device  2  can be radially contracted, as shown by arrows  174 . When the expandable support device  2  is sufficiently radially contracted  174  and/or in the recovery sheath  138 , the deployment tool  134  and the expandable support device  2  can be removed from the treatment site. 
         [0112]      FIGS. 53 and 54  illustrates that the deployment tool  134  can have a deployment rod key  176 . The deployment rod key  176  can be configured to interference fit against the device key  52  when the expandable support device  2  and the deployment tool  134  are in a locked configuration, as shown in  FIG. 54 . As shown in  FIG. 55 , when the deployment rod  148  is rotated into an unlocked configuration, as shown by arrow, the deployment rod key  176  can be configured to translate through the device key port  56 , and the device key  52  can translate through the deployment rod key port  178 . 
         [0113]    After being radially expanded, the expandable deployment device  2  can be detached from the deployment tool  134  by turning the deployment rod  148  to the unlocked configuration, and then proximally translating the deployment rod  148 . The expandable support device  2  can be radially contracted into the recovery sheath  138  by turning the deployment rod  148  to the locked configuration, and then distally translating the recovery sheath  138  while holding and/or proximally translating the deployment rod  148 . 
         [0114]      FIGS. 56  though  58  illustrate an expandable support device  2  explanted from a bone  180  can have bone substantially surrounding the struts  16 . The bone  180  can pass through the pores  14 . The struts  16  and joints  18  can be forced through the bone  180  during deployment of the expandable support device  2  in the bone  180 . The bone  180  can grow around the struts  16  and joints  18  after deployment. 
         [0115]      FIG. 59  illustrates the struts  16  can deploy through the bone  180 . When the struts  16  expand (e.g., during radial expansion of the expandable support device  170 ), the struts  16  can create voids or struts tracks  182 . The struts  16  can have a wide enough dimension transverse to the direction of radial expansion that the strut tracks  182  can be large enough to access and fill partially or completely with any material (e.g., BMP, bone cement, morselized bone, bone growth matrix). The struck tracks  182  can also be filled partially or completely with the threads or longitudinal vanes  96 . 
         [0116]      FIG. 60  illustrates that the strut  16  can be configured to leave a large or small strut track  182  during radial expansion of the expandable support device  170 . The width of the track  182  can correspond to the strut width. The struts  16  can have a narrow dimension transverse to the direction of radial expansion. For example, the strut  16  can have a diamond-shaped cross-section with a longer dimension in the radial dimension than the angular dimension (i.e., the strut dimension transverse to the radial dimension). The visco-elastic nature of bone (e.g., cancellous bone and/or cortical bone) can cause the bone to back-fill the tracks  182  as shown in  FIG. 60 . 
         [0117]      FIG. 61  illustrates that the strut  16  can be configured to leave a nominal or no strut track during radial expansion of the expandable support device  170 . The struts  16  can have a nominal or otherwise substantially no thickness in the angular dimension (i.e., the strut dimension transverse to the radial dimension). 
         [0118]    The expandable support device  2  can also be used for various other medical and non-medical applications: to immobilize and/or stabilize orthopedic trauma, hip fractures and other trauma, clavicle fractures and other trauma, small bones (e.g., carpals, tarsals, talus, other hand, feet and ankle bones) fractures and other trauma, other long bone repair (e.g., internal bone splinting), spinal fusion, use as an intermedullary canal implant to anchor an artificial joint, use as a bone anchor for a tendon repair or ligament implant (e.g., for anterior cruciate ligament repair or replacement), or combinations thereof. 
         [0119]    Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one). Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The above-described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination. All devices, apparatuses, systems, and methods described herein can be used for medical (e.g., diagnostic, therapeutic or rehabilitative) or non-medical purposes.

Technology Category: 1