Abstract:
A medical device and method of using the device to reinforce and stabilize a compressed tissue is disclosed. The medical device is inserted into the tissue, typically a vertebral bone, cuts the tissue inside, and then a binding cement is injected into the pulped tissue without removing the tissue. The medical device is designed to disrupt and pulp the tissue without exerting a compressive force against the walls by using thin blades that buckle away from the core, and by rotating the blades while expanding/contracting the blades at the same time.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation-in part of patent application Ser. No. 11/836,731, filed on Aug. 9, 2007, which claims priority to provisional patent application Ser. No. 60/893,556, filed on Mar. 7, 2007, which are both hereby incorporated by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The field of the invention is tissue reinforcement surgery. 
       BACKGROUND OF THE INVENTION 
       [0003]    Weakened tissue, especially bone, can cause multiple complications if it can not bear a certain threshold of weight. For example, compression fractures of the spine are a common, painful and debilitating complication of osteoporosis or neoplastic diseases of the vertebral bodies. In many patients, the pain is very severe and patients are unable to bear their own weight. This can require prolonged bed rest, which is known to lead to further complications including pneumonia, thromboembolism, muscle-decay, and further bone demineralization. In addition to being painful and debilitating, compression fractures of vertebral bodies also typically result in a loss of vertebral height along the anterior margin of the involved vertebrae. This leads to an anterior wedge deformity that causes the kyphosis. Patients having compression fractures of the spine are generally treated by a procedure called percutaneous Vertebroplasty. 
         [0004]    Common Vertebroplasty procedures involve drilling into a vertebral cavity, removing tissue from within the cavity, and then delivering polymethylmethacrylate (PMM) cement or other physiologically acceptable binding material into the body of the fractured vertebra. For example, US 2007/0197861 to Reiley teaches using a rotatable loop and cutting blade to sever the tissue, and then uses a rotatable brush or a suction tube to remove material within a bone before adding PMM cement. US 2008/0009875 to Sankaran teaches using expandable, rotatable blades which are used to sever the interior tissue, but then injects a liquid into the cavity before sucking out the tissue. The process of removing the severed tissue can cause further trauma to the patient, and could cause the walls of the cavity to compress and seal, decreasing the areas where the PMM could interdigitate with the uncut tissue walls. 
         [0005]    Reiley, Sankaran, and all other extrinsic materials discussed herein are incorporated by reference in their entirety. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply. 
         [0006]    Other methods of restoring a vertebral height involve inflating a balloon within the cavity, or using another object to push against the cavity walls to restore a vertebral height. U.S. Pat. No. 6,676,665 to Foley teaches a surgical instrument that pushes against the interior of a cavity wall to restore a vertebral height. Such compression techniques, however, also cause the walls of the cavity to seal, decreasing the areas where injected PMM could interdigitate with the uncut tissue walls. 
         [0007]    In view of the current state of the art, there is still a need in the art for tissue surgery apparatus and methods for reinforcing weakened tissue. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention provides apparatus, systems, and methods in which a volume of tissue is disrupted, and then reinforced in situ with a physiologically acceptable binding material. 
         [0009]    In especially preferred embodiments, little or none of the disrupted material is excised, although it is contemplated that some of the material could be permanently removed, or even removed and then replaced. It is less preferred embodiments, larger amounts of the disrupted tissue could be removed and/or replaced, including up to 10 wt %, 20 wt %, 30 wt %, 40 wt %, 50 wt %, etc. 
         [0010]    It is also preferred that the disrupting process does not appreciably compress tissues adjacent the disrupted tissue, as for example would occur with a Kyphoplasty. 
         [0011]    The tissue is generally disrupted using a medical device with a plunger that has a blade, and with a manipulator functionally coupled to the plunger that has a first mechanism that can extend the blade. 
         [0012]    The plunger can have more than one flexible blade that buckles from the plunger&#39;s core as the plunger squeezes two portions or positions of the blades towards one another. Typically, the ends of the blades are squeezed towards one another, and the positions that are squeezed can be more than 5 mm or 10 mm apart to enable the blades to extend farther from the core. Preferably, the blades can extend at least 10 mm from the plunger core. The blades are preferably flat, with have an average width of no more than 5 mm or 3 mm to minimize displacement of the disrupted tissue. Contemplated blades also include strong wire filaments or loops that slice through the tissue. Especially preferred blades have a width of 2-3 mm. Unless the context dictates otherwise, all ranges herein are to be deemed inclusive of their endpoints. 
         [0013]    The manipulator can have a second mechanism that rotates the blades around the axis, but preferably the same mechanism rotates and extends the blades. In an exemplary embodiment, the mechanism rotates and extends the blades at the same time, and retracts and rotates the blades at the same time. The simultaneous rotation and extension/retraction of the blades allows the blades to slice through the tissue while minimizing the amount of tissue displaced by the blade movement. 
         [0014]    Preferably, the plunger&#39;s distal end is no more than 5 mm in width or diameter and has a channel that is suitable for carrying a physiologically acceptable binding material into the disrupted tissue. 
         [0015]    To reinforce a weakened tissue, a skilled physician can insert the distal end of the claimed medical device, or another device with similar functionality, into a tissue. The physician disrupts a volume of the tissue with the device and injects a physiologically acceptable binding material into the disrupted volume of tissue, all without permanently removing or displacing at least 50 wt % of the disrupted volume. 
         [0016]    Typically the distal portion of the device is inserted through a cortex of a bone. A blade is then extended and rotated from that distal portion to disrupt a volume of tissue. The blade is preferably extended and rotated concurrently, and is retracted and rotated concurrently to minimize the amount of tissue that is displaced. The rotation of the blade can introduce multiple lacerations into the volume of tissue, and/or can pulp the volume of tissue. 
         [0017]    The physiologically acceptable binding material, for example PPM, is preferably injected directly into the disrupted volume of tissue. The binding material can be advantageously injected under pressure sufficient to interdigitate the material into the non-disrupted tissue, for example a lacerated tissue wall or an exposed trabecular bone. The physiologically acceptable binding material can be used to increase the height of a vertebral body, and thereby preferably restore the vertebral body to a normal, or at least more normal, anatomical height. 
         [0018]    Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawings in which like numerals represent like components. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIG. 1  is a partial cross-sectional view of an embodiment of a device of the present invention with its blades in a retracted position. 
           [0020]      FIG. 2  is a partial cross-sectional view of the embodiment depicted in  FIG. 1 . 
           [0021]      FIG. 3  is a top-down view of the embodiment depicted in  FIG. 2 . 
           [0022]      FIG. 4  is a partial cross-sectional view of an embodiment of a device of the present invention. 
           [0023]      FIG. 5  is a partial cross-sectional view of the embodiment depicted in  FIG. 4 . 
           [0024]      FIG. 6  is a partial side view illustrating an exemplary positioning of an embodiment of a device of the present invention within the vertebral body, wherein the blades of the device are in 11 retracted position. 
           [0025]      FIG. 7  is a partial side view illustrating the positioning of an embodiment of a device of the present invention, wherein the blades are in a deployed position and the vertebral height has been restored. 
           [0026]      FIG. 8  is a top-down view of an exemplary positioning of an embodiment of a device of the present invention within the vertebral body, wherein the device entered the vertebral body via the pedicle while avoiding the spinal canal. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    In the following paragraphs, the present invention will be described in detail by way of example with reference to the attached figures. Throughout this description, the preferred embodiment and examples shown should be considered as exemplars, rather than as limitations on the present invention. As used herein, the “present invention” refers to any one of the embodiments of the invention described herein, and any equivalents. Furthermore, reference to various feature(s) of the “present invention” throughout this document does not mean that all claimed embodiments or methods must include the referenced feature(s). 
         [0028]    A. Devices of the Present Invention 
         [0029]    Referring now to the figures, which are illustrative of multiple embodiments of the present invention only and are not for purposes of limiting the same,  FIG. 1  depicts an expandable blade device  10  constructed in accordance with one embodiment of the present invention. The expansion blade device includes a rigid housing  12  which defines a lumen  13 . Preferably the housing  12  is roughly tubular, but it may be any suitable shape or configuration. Housing  12  may be any suitable material, such as a suitable polymer, plastic, metal, or alloy. In some embodiments, housing  12  may be flexible. The lumen  13  is preferably tubular, but it may be any suitable shape or configuration. In preferred embodiments, the device  10  of the present invention is insertable within a cannula  60  which has been placed within the injured vertebra. Preferably, cannula  60  is a large bore cannula between about eight gauge to about eleven gauge created within a cortex of a bone. 
         [0030]    The housing  12  has a proximal end  14  and a distal end  16 . Preferably, distal end  16  is closed. In some embodiments, proximal end  14  includes grip member  18  that may aid a user&#39;s ability to grip and/or manipulate device  10 . In some embodiments, grip member  18  is located at proximal end  14 , but grip member  18  may be located near proximal end  14  or at any suitable position on housing  12 . In the depicted embodiment, grip member  18  is a pair of wings where each wing extends outwardly from proximal end  14  in opposed relation to the other. In such an embodiment, a user&#39;s index finger may be placed over one of the wings comprising grip member  18 , while the user&#39;s middle finger may be placed over the other wing comprising grip member  18 , similar to the handling of a syringe. In other embodiments, grip member  18  may be any suitable structure that may aid user&#39;s ability to grip and/or manipulate device  10 , for example finger loops, depressions, grooves, or a textured surface. 
         [0031]    As illustrated in  FIGS. 1 and 2 , plunger  20  is disposed within the lumen  13  of housing  12  such that plunger  20  is movable relative to housing  12 . Similar to housing  12  and lumen  13 , plunger  20  may be any suitable diameter and length. In preferred embodiments, plunger  20  has a diameter slightly less than lumen  13  such that plunger  20  is movable along the axis of the housing, but exhibits little, if any, movement transverse to the axis of the housing. In some embodiments, plunger  20  may be equipped with a structure or structures that facilitate its movement within the lumen  13 . In some embodiments, plunger  20  may be flexible. 
         [0032]    A manipulator  22  is located at or near the proximal end of plunger  20 . Manipulator  22  may be any structure suitable to permit the user to move plunger  20  relative to housing  12 . In some embodiments manipulator  22  may be a loop a lever, handle, or dial. In preferred embodiments, manipulator  22  is connected, directly or indirectly, to plunger  20  and blades  26  such that force acting upon blades  26  is transferred to manipulator  22 . Accordingly, in preferred embodiments, the user of device  10  is provided with a tactile feel. 
         [0033]    Attached to the distal portion of plunger  20  is a plurality of blades  26 . The use of multiple blades, as opposed to a single blade, allows for more surface area to contact the vertebral endplate and promotes more reliable fluoroscopic imaging in multiple planes. Each blade  26  may have any suitable width and each blade  26  in a given device need not have the same width. In some embodiments the blades  26  may have a width of from about 0.5 mm to about 10 mm. Preferably, each blade  26  has a width of from about 2 mm to about 3 mm, although smaller wire blades (where the effective width is the diameter of the wire) are also contemplated. Wire blades are thought to be advantageous in that they could cut through the tissue as the blades rotate, without pushing the tissue radially as a thicker blade or a Kyphoplastic operation would tend to do. The blades  26  are disposed substantially parallel to the axis of housing  12  and do not protrude past the outer surface of housing  12  in their unexpanded state. Each blade  26  may be composed of any suitable material that can cut or shave trabecular bone and is resilient. In some embodiments, blades  26  may be made of any compliant polymer, plastic, metal or alloy. Preferably, blades  26  are made of metal. Embodiments of the invention may feature any number of blades  26 . In some embodiments there may be 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 blades. In a preferred embodiment, there are six blades  26 . In another preferred embodiment, there are two blades  26 . 
         [0034]    In some embodiments, the distal portion of housing  12  has a plurality of slots  27 . Preferably the slots  27  are located close to the distal end  16 . The slots  27  maybe any shape and size so long as they do not impede radial expansion of the blades  26 . In the illustrated embodiment, the slots  27  are elongate rectangular in shape. 
         [0035]    Blades  26  are disposed such that when manipulator  22  is moved in a certain manner, the blades  26  will expand radially from the axis of the housing. In some embodiments, this is achieved by translating the distal movement of plunger  20  along the axis of housing  12 , for example as depicted in  FIG. 2 , in to the expansion or flexing of blades  26  radially away from the axis of the housing  12  and through slots  27 . In the illustrated embodiments such movement is achieved by attaching the proximal ends of blades  26  to plunger  20  and attaching the distal ends to housing  12 . 
         [0036]    Blades  26  may be attached to plunger  20  and housing  12  in any suitable manner, including indirectly. In some embodiments, blades  26  may be attached by welding, crimping, or with screws, rivets, or adhesives. The blades  26  may be attached to any suitable location of the plunger  20  and housing  12 . Preferably, the proximal ends of blades  26  are attached in proximity to the distal end  24  of plunger  20  and the distal ends of blades  26  are attached to an interior surface of the housing  12  at the distal end  16 . In a preferred embodiment, the proximal ends of blades  26  are each attached to a shoulder portion  25  of the plunger  20  which is located proximally to the distal end  24  of plunger  20 . 
         [0037]    The disposition of the blades  26  is also such that a diameter  100  of the blades  26  in the expanded configuration is variable.  FIG. 1  illustrates an embodiment where blades  26  are not expanded radially outward, whereas  FIG. 2  illustrates an embodiment that where the blades  26  are expanded to the maximum diameter. Although not depicted, the user may vary the extent of the expansion of the blades  26  and thereby vary the diameter  100  between the maximum and the unexpanded states. The user varies the diameter by varying the movement of the plunger  20  relative to the housing. The user may control this movement by acting upon the manipulator  22  and moving the manipulator  22  with respect to grip member  18 . Accordingly, for example, in  FIGS. 1 and 2  the user&#39;s movement of the manipulator  22  toward the distal end  16  of housing  12  moves plunger  20  toward the distal end  16  of housing  12 . In turn, the movement of plunger  20  moves the proximal end of blade  26  toward the distal end of blade  26 , thereby expanding blade  26  radially from the axis of housing  12 .  FIG. 3  depicts device  10  from a top-down perspective, with the blades  26  being in a fully deployed state illustrated in  FIG. 2 . As is illustrated in  FIG. 3 , each blade  26  protrudes through a slot  27  disposed within the rigid housing  12 . In some such embodiments, the distance of the movement of plunger  20  toward the distal end of housing  12  controls the amount of expansion of blade  26  and the diameter  100 . In a preferred embodiment, the maximum diameter between blades is about 2 cm. In some embodiments manipulator  22  is configured to display or otherwise notify the user of the cutting diameter of the blades  26 . For example, manipulator  22  or the distal portion of plunger  20  may have markings showing the extent of radial expansion of blades  26  achieved by a certain movement of manipulator  22 . 
         [0038]    While the blades may be biased in any suitable manner, or not biased at all, the blades are preferably biased to return to a straight configuration when no force is applied to plunger  20 . Blades  26  have shape memory properties, and are biased to return to their unexpanded position shown  FIG. 1 . In such embodiments, the blades  26  will remain expanded only so long as the user applies force to the manipulator  22  (and thereby to plunger  20 ). In alternative embodiments, the manipulator  22  is configured such that the user need not apply continuous force to maintain the expansion of blades  26 . In some such embodiments, the blades  26  may be maintained in a fully or partially expanded state through the use of a clamp, or some other fastening means (not shown) that is operable to maintain the plunger  20  in a prescribed position relative to the housing  12 . 
         [0039]    In some embodiments, device  10  may also have a guide wire engaging member  65  that functions to engage a structure that aids the insertion or other movement of device  10  within the body. In some embodiments, the guide wire engaging member  65  is within a hollow device  10  extending from its distal end  16  to the manipulator  22  (as depicted in  FIG. 1 ). In such an embodiment, plunger  20  would be hollow, as would manipulator  22  and distal end  16 . 
         [0040]      FIGS. 4 and 5  depict an alternative embodiment of a device of the present invention, device  10   a . Similarly to the device  10  depicted in  FIGS. 1 and 2 , device  10   a  comprises a housing  12   a  having a proximal end  14  and a distal end  16 , a grip member  18  (depicted as a pair of wings), lumen  13  and blades  26 . Device  10   a  may also have guide wire engaging member  65  (as illustrated in  FIG. 4 ). The depicted embodiment works in a manner similar to the embodiment depicted in  FIGS. 1 and 2 , but, among other differences, utilizes a manipulator  22   a , housing  12   a , and configuration of plunger  20   a  that are different than those in the embodiment depicted in  FIGS. 1 and 2 . 
         [0041]    In the embodiment depicted in  FIGS. 4 and 5 , a proximal portion of the interior surface of the housing  12   a  has a threaded region  36 . Similarly, a proximal portion of plunger  20   a  has a threaded region  32 . The threaded portion  32  is threadably engaged to the internally threaded portion  36  of the housing  12   a . As such, rotation of plunger  20   a  causes movement of plunger  20   a  along the axis of housing  12   a . Housing  12   a  does not extend to the distal end of the device  10   a  in this embodiment. Distal end  16  is near the proximal end of blades  26 . Blades  26  are attached at their proximal end to housing  12   a  and at their distal end to sleeve  34 . Sleeve  34  is rotatably connected to plunger  20   a  is an annular sleeve  34  which partially resides within a continuous, circumferentially extending groove  33  which is disposed in close proximity to distal end  38  of plunger  20   a . Sleeve  34  is capable of rotation relative to the screw unit  28  when the plunger  20   a  is rotated relative to the housing  12   a.    
         [0042]    Manipulator  22   a  in the depicted embodiment is a handle portion that extends radially from the axis of housing  12   a . In this embodiment, manipulator  22   a  is configured to allow the user to grasp and rotate manipulator  22   a  and, thereby rotate plunger  20   a . Of course, manipulator  22   a  can have any configuration capable of rotating plunger  20   a  relative to housing  12   a . In the depicted embodiment, blades  26  are extended by counter-clockwise rotation of manipulator  22   a  which, in turn, causes counter-clockwise rotation of plunger  20   a  relative to housing  12   a . In such an embodiment, the counter-clockwise rotation of manipulator  22   a  moves manipulator  22   a  away from the housing  12   a , thereby causing plunger  20   a  to move proximally along the axis of housing  12   a . Such movement decreases the distance between the distal end  16  of housing  12   a  and the distal end  38  of plunger  20   a  to decrease. Since the blades  26  are resilient and flexible and attached to the distal end  38  of plunger  20   a  and near the distal end  16  of housing  12   a , this decrease in distance forces the blades  26  to expand or flex (and hence deploy) radially from the axis of housing  12   a  in the manner illustrated in  FIG. 5 . Conversely, in the depicted embodiment, when manipulator  22   a  and plunger  20   a  are rotated in a clockwise direction, the distance between the distal ends  16  and  38  is effectively increased, causing the blades  26  to return to the initial, unexpanded position illustrated in  FIG. 4 . Like in device  10 , the blades  26  of device  10   a   10   a  may be partially expanded or deployed to a state lying anywhere between the extremes illustrated in  FIGS. 4 and 5  by selective variation in the degree of rotation of manipulator  22   a.    
         [0043]    Of course, one of skill in the art will appreciate that the device could be configured such that counter-clockwise movement contracts the blades  26  and clockwise movement expands the blades  26 . Blades  26  simultaneously cut through tissue and expand radially from the axis of housing  12   a  at in a predictable controlled manner since manipulator  22   a  follows the track of threaded region  36 . As a result, blades  26  cut tissue in spirally without exerting an outwardly radial, compressive force adjacent the disrupted tissue, as for example would occur with a Kyphoplasty or a thick blade that extends radially. Of course, thinner threads would tend to cut in a tighter spiral than thicker threads. It should also be appreciated that housing  12   a  can be rotated before rotating manipulator  22   a  counter-clockwise to contract blades  26  to cut the tissue along a separate spiral. By rotating manipulator  22   a  clockwise, rotating housing  12   a  a quarter turn, and then rotating manipulator  22   a  counter-clockwise, an operator can easily and efficiently pulp a relatively large volume of tissue. 
         [0044]    In some embodiments, the configuration of the screw mechanism is such that blades  26  will remain in a particular expanded state even though the user is not applying force to manipulator  22   a . Accordingly, the blades  26  can be maintained in the deployed position without continuous application of force by the user and without the need for any ancillary clamping or similar device. In such embodiments blades  26  will remain until plunger  20   a  is rotated in a clockwise manner and blades  26  are returned to their initial unexpanded position. 
         [0045]    In those instances when the user wants to rotate device  10  in its entirety, the user may simultaneously rotate the housing  12   a  and plunger  20   a . In another embodiment, such rotation may be assisted through the use of a clamp (not shown), or other fastening device or configuration operative to lock plunger  20   a  in place relative to the housing  12   a . In this case, when the clamp is locked, device  10   a  may be rotated in its entirety by either rotating the plunger  20   a  (or manipulator  22   a ) or the housing  12   a , without the user ensuring that the two are simultaneously rotating. 
         [0046]    B. Methods of the Present Invention 
         [0047]    In addition to the devices described above, the present invention also includes methods of using the devices of the present invention and any other suitable device. 
         [0048]      FIGS. 6-8  depict an embodiment of a method of the present invention useful to stabilize a vertebra fracture while also restoring the vertebral height. As depicted, the method uses device  10   a , but any suitable device may be used, including device  10  and any other embodiment of the devices of the present invention. 
         [0049]    The method initially involves getting access to the interior volume of vertebral body  42 . In some embodiments, this is done by percutaneously inserting a cannula  60 . In other embodiments, an open procedure may be used to get access to the interior volume of vertebral body  42 . Cannula  60  may be any structure suitable for providing access to vertebral body  42  and can be made of any suitable material. Preferably, cannula  60  is a hollow tube having a diameter slightly larger than the diameter of the device used in the procedure. In any event, the exterior surface of vertebral body  42 , for example a cortex of a bone, is drilled, cut, or otherwise compromised to permit access to the internal volume. Such maybe achieved by any suitable method and with any suitable device. 
         [0050]    The interior volume of vertebral body  42  can be accessed at any suitable position. In some embodiments, access may be through a side of vertebral body  42 . In other embodiments, access may be through the posterior of vertebral body  42 . In preferred embodiments, access to the internal volume of vertebral body  42  is through the pedicle  40 . As depicted in  FIG. 8 , by inserting cannula  60  into the vertebra body  42  through the pedicle  40 , the user is better able to avoid penetrating the spinal canal  50 , thereby preventing potentially permanent damage and paralysis to the patient. In some embodiments, the location of cannula  60  may be visualized by any suitable imaging technique, including those known in the art. Preferably, visualization is by fluoroscopic imaging techniques. 
         [0051]    After gaining access to the internal volume of vertebral body  42 , device  10   a  is inserted into that internal volume. In preferred embodiments, device  10   a  is inserted into and advanced through cannula  60 . In preferred embodiments, device  10   a  is inserted into the cannula with the blades  26  in an unexpanded state. In other embodiments, blades  26  may be expanded to some extent, so long as blades  26  do not prevent insertion of the device  10   a  into cannula  60  or into vertebral body  42 . The device  103  is advanced through the cannula so that the blades  26 ,  26  protrude beyond the distal end of the cannula  60  and into the internal volume of vertebral body  42 . In preferred embodiments, device  10   a  is moved or manipulated until blades  26  are near the anterior surface  44  of the vertebral body  42  as depicted in  FIG. 6 . In some embodiments, the extent of insertion of device  10   a  is monitored using a suitable imaging technique. 
         [0052]    When the device  10   a  is properly positioned within the vertebral body  42 , the blades  26  are expanded radially as needed to contact superior endplate  46 . The expansion of the blades  26  may be done by any suitable method, including those described herein. For example (and with reference to  FIGS. 4 and 5 ), in the case of device  10   a , the blades  26  may be expanded by rotating manipulator  22   a  counter-clockwise relative to housing  12   a , thereby causing plunger  20   a  to rotate counter-clockwise and decreasing the distance between the distal ends  16 ,  38 . Blades  26  are expanded such that they apply force to superior endplate  46  until the superior endplate  46  has been displaced into a desired position. In preferred embodiments, the desired position for superior endplate  46  is the normal anatomical position for the particular patient, for example as depicted in  FIG. 7 . Although the normal anatomical position of superior endplate  46  may be different for each patient or even each vertebrae of each patient, a preferred method, which will properly position the superior endplate  46  for many patients, contemplates expanding blades  26  to a diameter of about zero. 
         [0053]    In one embodiment, where the blades  26  are thin wires (1-3 mm dia.), the blades  26  are first rotated to cut a volume of tissue, and then are periodically rotated and slightly expanded to create lacerations in the tissue wall to help the physiologically acceptable binding material interdigitate with the tissue wall. In another embodiment, an outer surface of blades  26  is roughened to introduce multiple lacerations into the volume of tissue. 
         [0054]    In a preferred embodiment, the blades  26  are made of metal and are easily visualized using fluoroscopic methods. However, various other imaging techniques and methods, some capable of visualizing blades  26  that are not made of metal, may be used in other embodiments. However achieved, visualization of the blades  26  aids the user in expanding blades  26  as needed to achieve the desired orientation of the superior endplate  46 . Visualization may also aid the user in performing other aspects of the methods of the present invention. In some embodiments, the force of contact between blades  26  and superior endplate  46  is transmitted to the, user of device  10   a  through the manipulator. In some such embodiments, this tactile feel aids the user in determining if and when superior endplate has been moved to the desired position. In further embodiments the immediate tactile feedback provided to the user is combined with the visual fluoroscopic imaging, resulting in restoration of the vertebral height with minimal risk of rupturing the vertebral body itself. 
         [0055]    Expansion of the blades is also necessary for another aspect of the methods of the present invention that may be performed before or after the superior endplate  46  is restored-cutting, carving, shaving, or otherwise disrupting the volume of the trabecular bone  48  in the internal volume of vertebral body  42 . In preferred embodiments, the trabecular bone  48  is cut, carved, or shaved, preferably in a manner that leaves the trabecular bone with texture and/or pores that may receive a physiologically acceptable binding material. In a preferred embodiment once the blades  26  are expanded and the superior endplate  46  has been restored to the desired position, device  10   a  is rotated in its entirety to carve out the trabecular bone  48  within the vertebral body  42 , thereby creating a volume of disrupted tissue within the internal volume of the vertebral body  42 . 
         [0056]    The physiologically acceptable binding material may be instilled into the vertebral body by any suitable method using any suitable device. In one embodiment, device  10   a  is first removed and the physiologically acceptable binding material is instilled through the cannula  60  and into the vertebral body  42 , as is known in the art. Preferably, the device has a channel that allows a user to inject physiologically acceptable binding material into the volume of disrupted tissue without having to remove the device, and without actively removing any of the disrupted tissue. Any amount of physiologically acceptable binding material sufficient to add stability to vertebral body  42  may be used. Preferably, physiologically acceptable binding material is added until the height of vertebral body  42  is increased, or is restored to a normal anatomical height. In preferred embodiments where trabecular bone  48  has been cut, carved, or shaved, the physiologically acceptable binding material is injected under a pressure sufficient to interdigitate with the exposed trabecular bone  48 . In such embodiments, the interdigitation of the physiologically acceptable binding material and the trabecular bone  48  forms a bond that is capable of maintaining the restored vertebral height even after the subsequent placement of mechanical loading on the spine. 
         [0057]    Once the superior endplate  46  has been restored to the desired position, device  10   a  is withdrawn from the interior volume of the vertebral body  42 . Preferably, blades  26  are returned to their unexpanded state prior to removal of device  10   a . As used herein, a physiologically acceptable binding material is any material suitable for placement in an internal portion of a bone in a human body and that is capable of providing stability and/or added strength to such a bone. Preferably, the physiologically acceptable binding material is also capable of interdigitating with internal surfaces of a bone, such as trabecular bone. Examples of physiologically acceptable binding materials include, but are not limited to, cements containing polymethylmetacrylate (PMM) and materials utilizing biological or synthetic bone. The referred physiologically acceptable binding material is a cement that contains PMM. In some embodiments, the physiologically acceptable binding material may contain additional substances, such as antibiotics or compounds that aid imaging of the physiologically acceptable binding material once it is added to the body. In some embodiments, the physiologically acceptable binding material may contain barium to aid fluoroscopic imaging of the physiologically acceptable binding material. It is seen that devices and methods are provided. One skilled in the art will appreciate that the present invention can be practiced by other than the various embodiments and preferred embodiments, which are presented in this description for purposes of illustration and not of limitation, and the present invention is limited only by the claims that follow. It is noted that equivalents for the particular embodiments discussed in, this description may practice the invention as well. 
         [0058]    While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not of limitation. Likewise, the various diagrams may depict an example configuration for the invention, which is done to aid in understanding the features and functionality that may be included in the invention. The invention is not restricted to the illustrated example configurations, but the desired features may be implemented using a variety of alternative configurations. Indeed, it will be apparent to one of skill in the art how alternative functional or physical configurations may be implemented to implement the desired features of the present invention. Additionally, with regard to operational descriptions and method claims, the order in which the steps are presented herein shall not mandate that various embodiments be implemented to perform the recited functionality in the same order unless the context dictates otherwise. 
         [0059]    Although the invention is described above in terms of various exemplary embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead may be applied, alone or in various combinations, to one or more of the other embodiments of the invention, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments. 
         [0060]    Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one’ “one or more” or the like; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known,” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future. 
         [0061]    A group of items linked with the conjunction “and” should not be read as requiring that each and every one of those items be present in the grouping; but rather should be read as “and/or” unless expressly stated otherwise. Similarly, a group of items linked with the conjunction “or” should not be read as requiring mutual exclusivity among that group; but rather should also be read as “and/or” unless expressly stated otherwise. Furthermore, although items, elements or components of the invention may be described or claimed in the singular, the plural is contemplated to be within the scope thereof unless limitation to the singular is explicitly stated. 
         [0062]    The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. 
         [0063]    Additionally; the various embodiments set forth herein are described in terms of exemplary illustrations and figures. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives may be implemented without confinement to the illustrated examples. 
         [0064]    Thus, specific embodiments and applications of reinforcing a tissue have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C . . . and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.