Patent Publication Number: US-2007123877-A1

Title: Inflatable Device for Restoring Anatomy of Fractured Bone

Description:
PRIORITY  
      The application claims priority from the disclosure of U.S. Provisional Patent Application Ser. No. 60/736,797, entitled “Inflatable Device For Restoring Anatomy Of Fracture Bone,” filed Nov. 15, 2005, which is herein incorporated by reference in its entirety, from the disclosure of U.S. Provisional Patent Application Ser. No. 60/822,440, entitled “Inflatable Device For Restoring Anatomy Of Fractured Bone,” filed Aug. 15, 2006, which is herein incorporated by reference in its entirety, and from the disclosure of U.S. Provisional Patent Application Ser. No. 60/737,287, entitled “Kyphoplasty Variation Bone Repair Procedure,” filed Nov. 16, 2005 which is herein incorporated by reference in its entirety. 
    
    
     BACKGROUND  
      Versions of the present invention relate to restoring the anatomy of fractured bone and, more particularly, to restoring the anatomy of fractured bone with an inflatable device. A variety of medical devices have been created and used, but no one prior to the inventor(s) has created or used the invention described in the appended claims. 
    
    
     BRIEF DESCRIPTION OF THE FIGURES  
      It is believed the present invention will be better understood from the following description taken in conjunction with the accompanying drawings. The drawings and detailed description that follow are intended to be merely illustrative and are not intended to limit the scope of the invention.  
       FIG. 1  presents a longitudinal cross-sectional view of a fractured bone shown with an inflatable device inserted therein.  
       FIG. 2  presents a longitudinal cross-sectional view of the fractured bone of  FIG. 1  shown knitting after the insertion and inflation of the inflatable device therein.  
       FIG. 3   a  presents a longitudinal cross-sectional view of a fractured bone shown with an inflatable device having a dumbbell shape with one end of the inflatable device shown passing through one end of the bone.  
       FIG. 3   b  presents a longitudinal cross-sectional view of a fractured bone shown with one version of an inflatable device having a dumbbell shape.  
       FIG. 3   c  presents a longitudinal cross-sectional view of a fractured bone shown with one version of an inflatable device having a tapered dumbbell shape.  
       FIG. 3   d  presents a longitudinal cross-sectional view of the inflatable device of  FIG. 3   b  shown placed within a fractured bone having a central fracture.  
       FIG. 3   e  presents a longitudinal cross-sectional view of the inflatable device of  FIG. 3   c  shown placed within a fractured bone having a central fracture.  
       FIG. 4  presents a longitudinal cross-sectional view of a fractured bone shown with an inflatable device surrounding a portion of the bone.  
       FIG. 5  presents a longitudinal cross-sectional view of a fractured bone shown with an inflatable device having a guide or spine therein.  
       FIG. 6  presents a cross-sectional view taken along line  6 - 6  of  FIG. 1  of one version of an inflatable device having multiple chambers therein.  
       FIG. 7  presents a side view of one version of an inflatable device having projections at both ends thereof.  
       FIG. 8  presents a cross-sectional view taken along line  8 - 8  of  FIG. 7  of one version of an inflatable device having projections incorporated into the inflatable geometry of the inflatable device.  
       FIG. 9   a  presents an alternate cross-sectional view taken along line  8 - 8  of  FIG. 7  of an inflatable device having external projections.  
       FIG. 9   b  presents an alternate cross-sectional view taken along line  8 - 8  of  FIG. 7  of an inflatable device having internal and external projections.  
       FIG. 10  presents a side view of one version of an inflatable device having separately inflatable longitudinal projections extending substantially along the length of the inflatable device.  
       FIG. 11  presents a side view of one version of an inflatable device having longitudinal projections provided in the center of the inflatable device.  
       FIG. 12  presents a side view of one version of an inflatable device having projections at one end.  
       FIG. 13  presents a side view of one version of an inflatable device having annular rings incorporated into the surface thereof.  
       FIG. 14  presents a partial view of one version of an inflatable device having a plurality of inwardly projecting annular rings.  
       FIG. 15  presents a partial view of one version of an inflatable device having a plurality of outwardly projecting annular rings.  
       FIG. 16   a  presents a section view of one version of an inflatable device having a plurality of toothed rings angled in a first direction and a plurality of toothed rings angled in a second direction.  
       FIG. 16   b  presents a longitudinal cross-sectional view taken along line  16   a - 16   a  of the inflatable device of  FIG. 16   a.    
       FIG. 16   c  presents a section view of an alternate version of an inflatable device having a plurality of toothed rings angled in first direction and a plurality of toothed rings angled in a second direction.  
       FIG. 16   d  presents a longitudinal cross-sectional view taken along line  16   d - 16   d  of the inflatable device of  FIG. 16   c.    
       FIG. 17  presents a side view of one version of a threaded inflatable device.  
       FIG. 18  presents a side view of one version of an inflatable device having a plurality of annular rings and a plurality of longitudinal projections provided at the ends thereof.  
       FIG. 19  presents a side view of one version of a textured inflatable device.  
       FIG. 20  presents a side view of an alternate version of a textured inflatable device.  
       FIG. 21  presents a side view of an alternate version of a textured inflatable device.  
       FIG. 22  presents one version of an inflatable device configured in a dumbbell shape having texture at the ends thereof and a plurality of projections about the center, where the inflatable device is shown associated with a syringe and a delivery lumen having markings to indicate proper placement of the inflatable device in a bone cavity.  
       FIG. 23  presents one version of an inflatable device having randomly positioned rods configured at a plurality of angles.  
       FIG. 24  presents a fractured bone in need of repair having a first bone portion and a second bone portion.  
       FIG. 25  presents one version of a first inflatable device having a first tether inserted through the second bone portion and into the first bone portion of the fractured bone illustrated in  FIG. 24 .  
       FIG. 26  presents one version of a second inflatable device having a second tether inserted into the second portion of the fractured bone illustrated in  FIG. 24 .  
       FIG. 27  presents one version of the interaction of the first inflatable device and the second inflatable device, illustrated in  FIG. 26 , to provide a therapeutic effect.  
       FIG. 28  presents a fractured bone in need of repair having a first portion and a second portion.  
       FIG. 29  presents one version of an inflatable device having a first inflatable portion and a second inflatable portion, where the first inflatable portion is shown inflated in the first bone portion of the fractured bone, illustrated in  FIG. 28 , and the second inflatable portion is shown deflated.  
       FIG. 30  presents one version of the first bone portion and the second bone portion of the fractured bone, illustrated in  FIG. 28 , being compressed by drawing or urging the first inflatable portion of the inflatable device, illustrated in  FIG. 29 .  
       FIG. 31  presents one version of stabilizing the bone after the bone portions illustrated in  FIG. 30  have been joined, where the fractured bone is shown with the second inflatable portion of the inflatable device, illustrated in  FIG. 30 , inflated to provide stability to the bone.  
       FIG. 32  presents a fractured bone having a proximal portion and a distal portion with access holes therein, where the fractured bone is shown with wedge-shaped cavities removed from each end thereof.  
       FIG. 33  presents one version of an inflatable device having wedge-shaped portions corresponding to the wedge-shaped cavities of  FIG. 33 .  
       FIG. 34  presents one version of the inflatable device shown in  FIG. 33  being used to join fractured bone portions by applying pressure from the wedge-shaped portion of the inflatable device to the wedge-shaped cavities such that the proximal portion and the distal portion of the fractured bone are drawn together.  
       FIG. 35  presents a more detailed view of the relationship between the wedge-shaped portion of the inflatable device and the wedge-shaped cavity shown in  FIG. 34 .  
       FIG. 36  presents one version of an inflatable device, shown inserted into a fractured bone, having a first inflatable portion and a second inflatable portion, where the first inflatable portion is shown inflated and the second inflatable portion is shown deflated.  
       FIG. 37  presents one version of the inflatable device of  FIG. 36  shown with both the first inflatable portion and the second inflatable portion inflated.  
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      Versions of the present invention comprise an inflatable device for use in orthopedic procedures such as those directed towards restoring the anatomy of diseased or fractured bone. Any suitable bone, such as the humerus, may be prepped by providing a cavity therein in accordance with versions herein. Pre-existing cavities or pre-formed cavities, such as natural cavities formed within bones, may also be utilized. As will be discussed in greater detail, an inflatable device, such as a balloon, may then be inserted into the cavity. Once introduced, the inflatable device may be unfolded and/or inflated through the application of air, gas, fluid, a liquid matrix, bone paste, bone cement, bone matrix, or the like, via a lumen fluidly connected thereto. The terms “inflate” and “inflation” shall refer to distention with fluid and/or gas, an increase in volume, swelling, dilation, and/or expansion. The inflatable device may then be inflated intramedullarily with one of a plurality of lumens to apply outward pressure to the interior surface of the fractured bone. Applying pressure in the disclosed manner may provide a scaffolding upon which one or a plurality of bones may knit while the being maintained in a substantially natural shape and/or configuration.  
      For example, referring to  FIG. 1 , a fractured bone  100  is shown having an inflatable device  102  inserted therein, where the inflatable device  102  is shown uninflated.  FIG. 2  illustrates the fractured bone  100  of  FIG. 1  after the inflatable device  102  has been inflated, where inflation of the inflatable device  102  has substantially restored the geometry of the fractured bone  100 . The inflatable device  102  may be a single layer inflatable device, such as a balloon of predetermined size and/or shape, configured to conform to the internal cavity created in the bone  100  and to restore original anatomical shape and position of the bone  100 . For example, collapsed fractures of cortical bone may be treated by restoring the bone from an intramedullary approach. Inflation of the balloon with a fluid, gas, materials disclosed in greater detail herein, or the like, may take place via a delivery lumen  106 . Internal cavities in bone may be created using any suitable cutting technique or tool.  
      In one version, the inflatable device  102  may be any suitable device having elastomeric qualities, or partially elastomeric qualities, such as, for example, a balloon. The inflatable device may be provided associated with the fractured bone in any suitable mode or manner such that a therapeutic effect is achieved. For example referring to  FIG. 3   a , a through all hole in a bone  100  may be provided through which an inflatable device is inserted such that the distal end of the inflatable device passes through the bone and is positioned and inflated outside the distal end of the bone. The distal end of the inflatable device may be configured to inflate to a diameter greater than the through all hole where, after inflation, proximal tension may be applied to the inflatable device to tension the bone and provide therapeutic compression. It is further contemplated that an expandable portion of the inflatable device may be inflated within the bone to provide an outward pressure to stabilize the bone and to prevent fractured bone portions from collapsing upon each other.  
      As illustrated, for example, in  FIGS. 3   b - 3   e , the inflatable device  102  may be provided with multiple or one of a plurality of geometries such as, for example, a longitudinal shape, a dumbbell shape, a tapered dumbbell shape, a necklace shape having a plurality of in-line spheres, a circular shape, a collar shape, an annular shape, any other suitable shape or configuration, or combinations thereof. Additionally, the inflatable device  102 , or portions thereof, may be constructed from, or contain, a fibrous material configured to retain a desired geometry where, for example, increasing pressure within the inflatable device increases the rigidity of the device without substantially altering the shape of the inflatable device  102 . The inflatable device  102 , or portions thereof, may be made of a composite material having the flexibility and elastic characteristics of an elastomeric material, yet exhibit the growth limits of inelastic materials. Additionally, the inflatable device  102  may be placed in any suitable tissue such as a long bone having a single fracture, a long bone having a compound fracture, vertebrae, or any other suitable bone.  
      Referring to  FIG. 4 , the balloon or inflatable device  202  may be applied to the outer surface of the bone  100  to assist in healing a fracture, or the like. One or a plurality of inflatable devices  202  may be wrapped around, or otherwise associated with, the outer surface of the bone to target, for example, particular fractures in a bone. The inflatable device  202  may have a geometry tailored to mend the bone and to match the desired bone shape. The inflatable device  202  may be pressurized such that pressure is applied inward against the outer surface of the bone to mend fractures or the like. Providing an outer collar, for example, may provide a minimally invasive or non-invasive mode of healing damaged bones. In one version, a balloon applied to the outer surface of a bone may be used in combination with an inflatable device, such as the inflatable device  102  illustrated in  FIGS. 1-3   e , positioned within the bone, where the internal balloon may be inflated to exert outward pressure and the external balloon may be inflated to exert pressure inward to provide a therapeutic effect.  
      Referring to  FIG. 5 , in one version, the inflatable device  302  may be integrated with a rod or other spine member  304  to add support and/or guidance. The spine member  304  may be affixed to the inflatable device  302 , integral with the inflatable device  302 , flush with the inflatable device  302 , projecting from the inflatable device  302 , and/or otherwise suitable configured. The spine member  304  may be a central spine operably configured increase rigidity and to support compressive loads, tensile loads, bending loads, shearing loads, torsional loads, and rotational loads. Alternate versions of projections and rods are disclosed in more detail herein. It is contemplated that any suitable shape or configuration of inflatable device may be provided in accordance with versions herein. It is further contemplated that the inflatable device may have projections therefrom, such as inflatable or solid protrusions, which may be used to grasp, hold, and/or secure portions of the bone.  
      Referring to  FIG. 6 , a cross-sectional view of an inflatable device  402  is shown taken along line  6 - 6  of  FIG. 2 . The balloon or inflatable device  402  may have multiple layers, lumens, tubes, cavities, or the like to provide desired surface characteristics, resistance to puncture and tearing, or other beneficial properties. Additionally, the inflatable device may be provided with multiple discrete chambers, cavities, lumens, tubes, or the like adapted to perform various functions. For example, as illustrated, the inflatable device  402  includes an outer chamber  404  having a porous outer surface  406  that is connected to a delivery lumen (not shown), where an adhesive or the like may be administered through the delivery lumen into the outer chamber  404 . The addition of an adhesive, bone matrix, bone paste, bone cement, synthetic paste, therapeutic agent, healing agent, structural agent, or other suitable material, may assist or speed the healing process, assist in fitting the balloon properly, provide a dye or visual marker or the like to visually identify the position of the balloon in a bone through scans or x-ray, provide structural support, or serve any other suitable purpose. It will be appreciated that the outer chamber  404  is disclosed by way of example only, where any suitable number of chambers for any suitable purpose are contemplated.  
      For example, in an alternate version, the outer chamber may include one or a plurality of rods, bands, support members, stabilizers, projections, or the like that may be inflated via an independent delivery lumen. Inflating the projections, or the like, of an inflatable device may allow a user to tailor the amount of rigidity, stability, texture, or the like, of the inflatable device desirable for a given procedure. The pressure of the projections or texture may, for example, be controlled independently from the inflation of the inflatable device.  
      A second chamber  408 , connected to a delivery lumen (not shown), may be provided and configured to pressurize the bone in an intramedullary fashion. A third chamber  410 , connected to a delivery lumen (not shown), may be provided and configured to receive a liquid capable of solidifying within the bone to restore the original anatomical shape or size thereof. The first chamber  404 , the second chamber  408 , and the third chamber  410  may be used in combination to effectively treat and repair fractured bones. It will be appreciated that the illustrated chambers  404 ,  408 ,  410  are disclosed by way of example only and may be tubes, lumens, cavities, portions, inflatable elements, or the like and that any suitable number of configurations of chambers may be provided. For example, the inflatable device may have two chambers, three chambers, four chambers, five chambers, six chambers, or any other suitable number where, for example, each chamber may have a designated function.  
      Once the fractured bone has been sufficiently restored, the one or a plurality of balloons, inflatable devices, lumens, or the like may be deflated and/or removed, may be left inside the bone to degenerate, may be left in the bone as part of the new bone growth, or may otherwise be managed to provide a therapeutic effect. The inflatable device may be provided with luminous sections and/or regions of porosity for the delivery of therapeutic agents, bonding agents, or the like, and may be treated to exhibit regions of distinct compliance. In one version, a multi-luminal tube is operably configured to facilitate the insertion of therapeutic or bonding agents at, for example, the same rate that the balloon is being deflated such that the anatomical position and shape of the treated bone are substantially maintained where, for example, the third chamber  410  is filled with a liquid cement as the second chamber  408  is deflated.  
      Referring to  FIGS. 7-23 , versions of the inflatable device may have projections or the like extending therefrom to reduce the torsional and/or axial movement of the inflatable device during placement and/or to prevent slippage of the balloon or inflatable device. Referring to  FIG. 7 , an inflatable device  502  may include longitudinal ridges or projections  504  projecting laterally therefrom to provide torsional and/or longitudinal rigidity to the balloon, torsional and longitudinal stability to the bone, and/or to increase the friction coefficient of the balloon when it engages the inner surface of a bone. As illustrated, the projections  504  may be placed at each end of the balloon, or at any other suitable location.  
      Referring to  FIG. 8 , shown is a cross-sectional view of the inflatable device  502  of  FIG. 7 . As illustrated, the projections  504  may be made from the geometry of the balloon surface when inflated. The outer surface  508  of the inflatable device  502  may take on a textured shape or the shape of a support member upon inflation, where portions of the balloon may function as longitudinal support members, annular support members, woven support members, or any other configuration of support member or texture inflated in association with the inflation of the inflatable device.  
      Referring to  FIG. 9   a , a cross-sectional view of an alternate version of an inflatable device  602  is shown having projections  604  that may be configured from hardened or shape retention material and may function as longitudinal support members, annular support members, woven support members, or any other configuration of support member or texture. The projections  604 , ridges, extensions, protuberances, surface changes, material changes, and/or texture may be configured from material that maintains the general shape of the projections or the like in the absence of inflation. The projections  604 , or the like, may be formed from hardened materials, semi-rigid materials, rigid material, memory retention material, or any other suitable material.  
      Referring to  FIG. 9   b , one version of an inflatable device is depicted having both internal projections  706  and external projections  704 . Providing both internal projections  706  and external projections  704  may further increase the axial and torsional rigidity of the inflatable device  702 . It will be appreciated that the projections, support members, or the like, may be integrated into the surface of the inflatable device, may be lateral outward projections, may be inward projections, or may have any other suitable configuration to improve the torsional rigidity and axial or longitudinal rigidity of the balloon, the longitudinal and torsional stability of the bone, and/or to diminish the slippage of the inflatable device.  
      Referring to  FIGS. 10-12  the torsional rigidity and the longitudinal or axial rigidity of the inflatable device may be improved by incorporating rods or tubes, such as semi-rigid longitudinal rods, into all or a portion of the inflatable device. The rods or tubes may extend longitudinally along the length or along a portion of the inflatable device and may be placed at more specific areas where longitudinal motion, torsion, and/or torsional slipping are more likely to occur. The projections or rods may be solid, may be inflatable, may be independently inflatable from the inflatable device, or have any other suitable configuration.  
      Referring to  FIG. 10 , an inflatable device  802  is shown having a delivery lumen  806  associated therewith and a plurality of projections  804 , where the projections  804  are independently inflatable via a delivery lumen  805 . With reference to all versions herein, the rods or tubes may be made of any suitable material such as balloon material, semi-rigid material, short segments of rigid material, tacky material, memory retention material, adhesive material, rigid material, elastomeric material, and/or any other suitable material. In one version, the rods, tubes, projections, texture or the like are inflatable via a lumen separate from that of the inflatable device. The tubes, texture, rods, or the like may then be pressurized or sized via the associated lumen to a desirable pressure, size, configuration, shape, or the like. Referring to  FIG. 11 , an inflatable device  902  is shown having projections  904  positioned at about the center thereof. Referring to  FIG. 12 , an inflatable device  1002  is shown having projections  1004  at about the distal end thereof.  
      The rods or projections, which include tubes, bars, spines, protuberances, extensions, support members, combinations thereof, or the like, may be inserted into, attached to, affixed to, coupled with, or formed integrally with the inflatable device in a linear configuration, in a non-linear configuration, in an annular configuration, in a lateral configuration, in a longitudinal configuration, in a wave-shaped configuration, in a random configuration, in a non-linear configuration, in a threaded configuration, and/or in any other suitable configuration. The inflation of the rods and other projections may be independent of the inflatable device or integral with the inflatable device. The projections or the like may project in any suitable direction or manner, such as outwardly from the inflatable device, as shown in  FIG. 7 , or inwardly towards the centroid of the balloon, as shown in  FIG. 9   b.    
      Referring to  FIG. 13 , an alternate version of an inflatable device  1102  is shown where the torsional rigidity and longitudinal rigidity of the balloon may be increased by altering the material characteristics of portions of the balloon. Portions of the inflatable device  1102  may be provided with hardened annular bands  1104  flush with the inflatable device  1102  to provide torsional and/or longitudinal rigidity and/or stability. The annular bands  1104  may be rigid, semi-rigid, deformable with memory retention capabilities, or have any other suitable configuration. It will be appreciated that any suitable portions, such as longitudinal strips or bands, of an inflatable device may be hardened or otherwise providing with modified material characteristics. The annular bands may be contiguous, intermittent, or have any other suitable configuration.  
      Referring to  FIG. 14 , adding annular band projections  1204  to an inflatable device  1202  that project inwardly may improve the torsional and longitudinal rigidity of the inflatable device and the torsional and longitudinal stability of the bone. The annular band projections  1204  may be configured from materials and in a manner similar to the longitudinal support members described herein. The annular band projections  1204  may be a separate inflatable device associated with a balloon, where the annular band projections may be inflated with a dedicated delivery lumen (not shown). The annular band projections  1204  may be tapered, beveled, rounded, or provided with any other suitable configuration.  
      Referring to  FIG. 15 , adding annular band projections  1304  to an inflatable device  1302  that project outwardly may improve the torsional and longitudinal rigidity of the inflatable device and the torsional and longitudinal stability of the bone. The annular band projections  1304  may be configured from materials and in a fashion similar to the longitudinal support members described herein. The annular band projections  1304  may be a separate inflatable device associated with a balloon, where the annular band projections may be inflated with a dedicated delivery lumen (not shown). It will be appreciated that an inflatable device may be provided with both internally and externally projecting annular band projections. It will be further appreciated that each of the annular bands may be a contiguous annulus or band, an intermittent band, or any other suitable configuration.  
      Referring to  FIGS. 16   a - 16   d , an inflatable device  1402  may be provided with ridges, teeth, or the like. As illustrated, the ridges may be angled teeth having a ratchet-like function such that upon insertion the inflatable device is resistant to movement or removal. The ridges may point in the same direction, in opposite directions at opposite ends, as illustrated by ridges  1404  and ridges  1406 , in a random configuration, in a threaded configuration, in an annular configuration, in a longitudinal configuration, in a contiguous configuration, in an intermittent configuration, and/or in any other suitable configuration. The ridges  1404  and ridges  1406  may maintain fractured bone portions in proximity to one another, yet also may provide resistance against the bone portions collapsing inward upon each other.  
      Referring to  FIG. 17 , an inflatable device  1502  may be provided with one or a plurality of threaded projections  1504 . The threaded projections  1504  may extend internally and/or externally and may increase the torsional and/or axial rigidity of the inflatable device. In one version, the inflatable device may be provided with a rod, tube, material property, or the like, flush with the surface thereof to increase the torsional or axial rigidity.  
      Referring to  FIG. 18 , in one version of an inflatable device  1602  a plurality of annular bands  1604  may be combined with a plurality of rods  1606  to improve the torsional and longitudinal rigidity of the inflatable device and/or to reduce slippage on the bone. It will be appreciated that any combination of texture, projections, support, configuration, shape, size, or the like of embodiments disclosed herein is contemplated.  
      Referring to  FIGS. 19-23 , the surface of a balloon or inflatable device may be textured or otherwise modified or altered to decrease slippage and to prevent torsion or axial movement of at least a portion of the balloon. Texture or surface effect may also increase the rigidity of the balloon. The surface texturing may be combined with or may include rods, support members, annular bands, tubes, projections, or the like, to increase the rigidity and reduce the slippage of the inflatable device.  
      Surface texture or a surface effect may be accomplished with attachments, projections, additives, protuberances, extensions, or the like from the balloon surface. The projections may be, for example, affixed pieces of plastic, injection molded projections, particles sprayed on with an adhesive, an abraded surface, or the like, where the texture or surface effect may otherwise be affixed to, inserted into, created on, or constructed integrally with the balloon.  
      The projections, for example, may be circular in shape, rod-like in shape, amorphous in shape, symmetrical in shape, asymmetrical in shape, of varying size, of varying shape, of uniform size, of uniform shape, of varying height, of uniform height, or combinations thereof. Referring to  FIG. 19 , surface texture  1704  may be provided to an inflatable device  1702  at any suitable location, including those areas where slippage is likely to occur, where bending strength is most needed, and/or where torsional and axial rigidity is most desirable, such as at about the ends of the inflatable device  1702 .  
      Referring to  FIG. 20 , the surface effect or texture  1804  of a portion or all of the inflatable device  1802  may be particulate or granular to prevent or reduce slippage of the inflatable device  1802 . For example, sand, granular, or particulate matter may be incorporated into the surface of the balloon at both ends thereof. The particulate may be manufactured integrally with the inflatable device, may be affixed by spraying on the particulate with an adhesive, or may otherwise be suitably attached. It will be appreciated that versions illustrated herein may be combined to provide a desirable combination of torsional rigidity, longitudinal rigidity, and/or reduced slippage.  
      Referring to  FIG. 21 , the texture or friction coefficient of the balloon may be increased with a woven portion, tread portion, raised portion, and/or patterned portion  1904  present on at least a portion of the surface of the inflatable device  1902 . The raised or patterned portion  1904  of the balloon may be configured from the same material as the inflatable device  1904 , a semi-rigid material, a thread-like material, a fibrous material, a memory retention material, a rigid material, or any other suitable material to provide the inflatable device  1902  with a woven or patterned tread. The patterned portion  1904  of the inflatable device  1902  may be created integrally with the balloon upon construction, may be added to the balloon at a second time, may be woven around the inflatable device, may be affixed with an adhesive, and/or may otherwise be suitably attached. It will be further appreciated that various materials having different friction coefficients may be combined to reduce slippage of the inflatable device  1902  at, for example, different locations on the inflatable device  1902 . For example, particulates of different grades may be utilized at various locations, different patterns may be utilized, different combinations of projections and particulates may be utilized, or any other suitable combination.  
      Referring to  FIG. 22 , the inflatable device  2002  or balloon may be any suitable shape including, as illustrated, a dumbbell-shaped balloon. It is further contemplated that the inflatable device or balloon shapes may be linear, amorphous, symmetrical, tapered, tapered dumbbell, pearl necklace-shaped, shaped to correspond to a particular anatomy, curved, round, spherical, or any other suitable shape. The inflatable device  2002  may include, for example, texture, projections, or protuberances  2004  on a first dumbbell portion  2006  and a second dumbbell portion  2008  of the inflatable device  2002  to prevent slippage of the inflatable device  2002 . In addition to the texture, projections, or protuberances  2004 , the inflatable device  2002  may include rods or support members  2010 , such as along the central portion  2012  of the inflatable device  2002 , to increase the torsional rigidity, axial rigidity, and bending strength of the inflatable device  2002 .  
      Still referring to  FIG. 22 , the inflatable device  2002  may be inflated with any suitable inflation device  2020 , such as a syringe, via a delivery lumen  2018 , where fluid, air, gas, gel, hardening agents, scaffolding agents, adhesive agents, therapeutic agents, dye agents, and/or any other suitable substance may be injected or otherwise inserted into or around the inflatable device  2002 . A tube or delivery lumen  2018  may connect the syringe or inflation device  2020  to the inflatable device  2002 , where the delivery lumen  2018  may be provided with incremental markings to indicate how far the inflatable device  2002  has been inserted into a bone  2000  in order to determine proper placement. For example, a series of lines may be provided along a tube or lumen to indicate when the distal end of the balloon has been inserted into the distal end of the bone cavity.  
      Referring to  FIG. 23 , disclosed is one version of a longitudinal inflatable device  2102  having a plurality of projections  2104  positioned thereon. The projections  2104  may be rods of substantially identical or similar shape positioned at random about portions of the inflatable device  2102 , such as at the ends thereof, to increase torsional rigidity, longitudinal rigidity, and/or to prevent slippage. In one version, such projections  2104  may be placed in a pre-selected pattern, where the location of the projections  2104  on the inflatable device  2102  is uniform, but the rotational orientation of each of the projections  2104  is selected randomly such that the projections  2104  generally point in a variety of directions. Alternate versions include providing any suitable shape such as star shapes, cross shapes, or spirals.  
      Referring to  FIGS. 24-27 , one version of a system and method for healing a fractured bone  2200  is disclosed.  FIG. 24  illustrates a fractured bone  2200  split into a first portion  2202  and a second portion  2204 . The illustrated bone  2000  depicts a first cavity  2206  and a second cavity  2208  that may be created through an access point  2210  at one end of the bone, via access points at both ends of the bone, or by any other suitable device, method, mechanism, or mode at any suitable location. One or a plurality of cavities having any suitable shape or configuration may be created in the fractured bone prior to insertion of one or a plurality of inflatable devices. The cavities may include one or a plurality of central bores through, for example, long bones.  
       FIG. 25  illustrates one version of a first inflatable device  2302  that is inserted through an access point  2210  in the second portion  2204  of the fractured bone  2000  into a cavity  2206  of the first portion  2202  of the fractured bone  2200 . The first inflatable device  2302  may include a first tether  2304  extending proximally therefrom that extends back through the access hole  2210  and out of the body for manipulation by a clinician. The first tether  2304  may be a tube, a cannulated member, a flexible cord, a rigid rod, a semi-rigid rod, a guide, or any other suitable connection. The first tether  2304  may be a delivery lumen, a support rod, an actuator, an indicator of position or placement, and/or any other suitable device.  
      The first inflatable device  2302  may be inserted into the first portion  2202  of the fractured bone  2000  in a deflated state where, upon placement and positioning, the first inflatable device  2302  is inflated to a size greater than the access point  2210  in the second portion  2204  of the bone or to a size sufficiently large to substantially secure the first inflatable device  2302  within the bone. The inflation of the first inflatable device  2302  may secure the first inflatable device  2302  within the first bone portion  2202  by pressing against the inside surface of the bone.  
      Referring to  FIG. 26 , after placement of the first inflatable device  2302 , a second inflatable device  2352  may be inserted into the cavity  2208  of the second bone portion  2204  through the access point  2210 . The second inflatable device  2352  may have a second tether  2354  associated therewith that passes proximally through the access point  2210  and out of the body for manipulation by a clinician. The second tether  2354  may be a tube, a cannulated member, a flexible cord, a rigid rod, a semi-rigid rod, a guide, or any suitable connection and may include a delivery lumen for inflation. The second inflatable device  2354  may include a passageway  2356 , such as a central bore, through which the first tether  2304  of the first inflatable device  2302  may pass. The first tether  2303  of the first inflatable device  2303  may act as a guideline along which the second inflatable device  2352  may be inserted into the fractured bone  2000 .  
      The second inflatable device  2352  may be placed at any location along the fractured bone  2200  such as, for example, forward of the fracture  2207 , at about the fracture  2207 , or rearward of the fracture  2207 . Upon insertion and placement, such as in the second bone portion  2204 , the second inflatable device  2352  may be inflated such that it is retained within the cavity  2208 . The inflation of the second inflatable device  2352  may secure the second inflatable device  2352  within the second bone portion  2204  by pressing against the inside surface of the bone and/or by inflating to a size greater than a reduced diameter portion of the bone. It will be appreciated that any of the disclosed steps may be performed in any suitable order where the second inflatable device, for example, may be placed prior to the placement of the first inflatable device.  
      Referring to  FIG. 27 , one method of rejoining the first and second bone portions  2202 ,  2204  of the fractured bone  2200  is disclosed. After inflating both the first inflatable device  2302  and the second inflatable device  2352 , the first inflatable device  2302  may be drawn proximally, in the direction of the access point  2210 , with the first tether  2304  towards the second bone portion  2204 . The second bone portion  2204  may be held static or pushed proximally with the second tether  2354  to facilitate reconnection. By manipulating the bone portions  2202 ,  2204  with the first and second tethers  2304 ,  2354 , respectively, the clinician may rejoin the bone portions to encourage knitting. It will be appreciated that the tethers  2304 ,  2354  may be tensioned or otherwise configured or manipulated to restrict the bone portions from collapsing upon one another or otherwise improperly healing.  
      To join the fractured bone portions  2202 ,  2204 , it will be appreciated that the first bone portion  2202  may be held substantially still while the second bone portion  2204  is urged distally, the first bone portion  2202  may be pulled proximally while the second bone portion  2204  is pushed distally, or the first bone portion  2202  may be pulled proximally in the direction of the access point  2210  while the second bone portion  2204  is held substantially still. The tethers  2304 ,  2354  may be adjusted or manipulated by the clinician such that the desired fit and/or compressive force between the bone portions  2202 ,  2204  is achieved, where the force may be sufficient to reconnect the bone portions  2202 ,  2204  but not over compressed such that the bone portions  2202 ,  2204  collapse upon each other. It will be appreciated that the illustrated example discloses two portions of a fractured bone by way of example only, where a plurality of inflatable devices may be used to rejoin and/or compress a plurality of bone portions in a compound or multi-piece bone fracture. It will be appreciated that methods of reconnection disclosed herein may include the incorporation of texture, projections, or the like into the inflatable devices.  
      Referring to  FIGS. 28-31 , an alternate version of a system and method for healing a fractured bone  2200  is disclosed.  FIG. 28  illustrates a fractured bone  2200  split into a first bone portion  2202  having a first cavity  2206  and a second bone portion  2204  having a second cavity  2208  provided therein. The cavities  2206 ,  2208  may be provided by any suitable mode, method, or device. It will be appreciated that pre-cut cavities may not be provided where, for example, the device may be directly inserted into a portion of a bone or existing bone cavities may be used.  
       FIG. 29  illustrates one version of a first inflatable device  2402  that is inserted through an access point  2210  in the fractured bone  2200  into a cavity  2206  of the fractured bone  2200 . The first inflatable device  2402  may include a first tether  2404  extending proximally therefrom that extends back through the access hole  2210  and out of the body for manipulation by a clinician. The first tether  2404  may be a tube, a cannulated member, a flexible cord, a rigid rod, a semi-rigid rod, a guide, and/or any other suitable connection. The first inflatable device  2402  may be inserted into the first bone portion  2202  of the fractured bone  2200  in a deflated state where, upon placement and positioning, the first inflatable device  2402  is inflated to a size greater than a region of the bone having a lesser diameter. The inflation of the first inflatable device  2402  may secure the first inflatable device  2402  within the first bone portion  2202  by pressing against the inside surface of the bone and/or by inflating to a size greater than the access point  2210  to the first bone portion  2202 . Surface effects, configuration of the inflatable device, and/or the material provided may facilitate securing the inflatable devices within the bone.  
      In an alternate version, the first inflatable device may be configured for placement within the shaft of a bone, such as where the first inflatable device has a cylindrical configuration (not shown), where inflation of the cylinder may exert pressure on the interior surface of the bone for stability or movement. It will be appreciated that any inflatable devices or balloons disclosed and described in accordance with methods herein is by way of example only where, for example, a balloon shown inflated within a cavity may be replaced by a balloon inflated along a bone shaft, or the like, and vice versa.  
      Still referring to  FIG. 29 , a second inflatable device  2452  is provided that may be used in cooperation with the first inflatable device  2402 . The second inflatable device  2452  may be placed in proximity to, coupled with, or affixed to the first inflatable device  2402 . The second inflatable device  2452  may include a second tether  2454  for manipulation and/or inflation and may include a passageway  2456 , such as a central bore, therethrough to accommodate the first tether  2404 . The second inflatable device  2452  may be an elongated balloon positioned proximal to the first inflatable device  2402  in the direction of the access point  2210 . The second inflatable device  2452  may be positioned forward of the bone fracture  2207 , at about the fracture  2207 , or rearward of the fracture  2207 .  
      Referring to  FIG. 30 , the first bone portion  2202  of the fractured bone  2200  may be drawn by the first tether  2404  towards the second bone portion  2204 . Once rejoined, the first tether  2404  may be used to provide compressive force between the bone portions  2202 ,  2204 . As with all compressive loading versions herein, the tether may be secured such that compressive loading of the bone portions is maintained to sustain a therapeutic level for knitting without overloading or over compressing the bone coupling such that the portions collapse upon each other.  
      Referring to  FIG. 31 , the fractured bone  2200  may be further encouraged to heal by inflating the second inflatable device  2452  after the fractured bone portions  2202 ,  2204  have been joined. The second inflatable device  2452  may be inflated via the second tether  2454  associated therewith such that pressure is applied outwardly against the inner surface of the bone. The longitudinal compressive load provided by the first inflatable device  2402  and first tether  2404 , in combination with the stabilizing force provided by the second inflatable device  2454 , may serve to speed the healing process of the fractured bone  2200  and may encourage the bone to mend in a manner substantially consistent with the original anatomy of the bone.  
      Upon healing or joining of the fractured bone  2200 , the first and second inflatable devices  2402 ,  2452  may be deflated, the inflatable devices  2402 ,  2452  may be removed from the bone, the inflatable devices  2402 ,  2452  may be left as they were during the healing process, and/or the inflatable devices  2402 ,  2452  or cavities  2206 ,  2208  may be filled. The inflatable devices  2402 ,  2452  or cavities  2206 ,  2208  may be filled with cement, bone matrix, bone paste, synthetic paste, hydroxy appetite, PMMA, a balloon inflated with fluid or air, materials disclosed herein, and/or any other suitable material. In the alternative, the inflatable devices  2402 ,  2452  or cavities  2206 ,  2208  may be left unfilled. It will be appreciated that any suitable number of inflatable devices configured to provide a compressive force and inflatable device configured to provide stabilization may be combined depending on the anatomy of a fracture or the needs of a procedure. It will be further appreciated that the method and system disclosed in  FIGS. 24-27  may be used in combination with the method and system disclosed in  FIGS. 28-31  to effectively mend fractured bones.  
      Referring to  FIG. 32-34 , one version of a system and method for healing a fractured bone  2500  is disclosed.  FIG. 32  illustrates a fractured bone  2500  split into a first bone portion  2502  having a first wedge shaped cavity  2506  and a second bone portion  2504  having a second wedge shaped cavity  2508  formed therein. In the illustrated version, the first and second bone portions  2502 ,  2504  of the fractured bone  2500  have been provided with wedge shaped cavities  2506 ,  2508  via access points  2510 ,  2511 , respectively, where the wedge-shaped cavities  2506 ,  2508  may be provided by any suitable cutting instrument and may be joined by a hollow bore  2513 . It will be appreciated that the cavities may be formed via one or a plurality of access points or by any other suitable method or mode.  
       FIG. 33  illustrates one version of an inflatable device  2602  that is inserted through an access point  2510  in the fractured bone  2500 , illustrated in  FIG. 22 , and into the wedge-shaped cavities  2506 ,  2508  formed therein. The inflatable device  2602  may have a first wedge-shaped end  2606  and a second wedge shaped end  2608  substantially corresponding to the wedge-shaped cavities  2506 ,  2508 , respectively, in the portions of the fractured bone  2500  and a central longitudinal portion  2613  corresponding to the central bore  2513 . The inflatable device  2602  may include a tether  2620  extending therefrom that extends back through an access hole and out of the body for manipulation by a clinician. The tether  2620  may be a tube, a cannulated member, a flexible cord, a rigid rod, a semi-rigid rod, a guide, or any suitable connection and may have a delivery lumen for inflation.  
      Referring to  FIGS. 34-35 , the inflatable device  2602  may be inserted into the wedge-shaped cavities  2506 ,  2508  of the fractured bone  2500  in a deflated state where, upon placement and positioning, the wedge-shaped dumbbell balloon may be inflated. Inflation of the wedge-shaped ends of  2606 ,  2608  of the inflatable device  2602  may compress the surface of the corresponding wedge-shaped cavities  2506 ,  2508  such that the expansion of the inflatable device  2602  urges the fractured bone portions  2502 ,  2504  towards one another. The inflatable device  2602  may also be configured to provide outward resistance or compressive force such that the bone portions  2502 ,  2504  do not collapse upon each other. Securing the bone portions in both directions may be accomplished, for example, with cavities having a diamond shape corresponding to a balloon having diamond-shaped ends. Still referring to  FIGS. 34-35 , the wedge-shaped portions or ends  2606 ,  2608  of the inflatable device  2602  may be inflated until the bone portions  2502 ,  2504  are rejoined and a desired compressive force is achieved. The compression may be retained, removed, reduced, adjusted, or otherwise manipulated or maintained therapeutically until the bone heals.  
      Although wedge-shaped cavities and a wedge-shaped dumbbell inflatable device are disclosed by way of example, it will be appreciated that any suitable inflatable device and cavity configuration that, by inflation, rejoins portions of a bone or assists in orthopedic therapy, is contemplated. For example, the inflatable device may have a dumbbell configuration with substantially spherical ends corresponding to spherical cavities. Providing such an inflatable device may beneficially assist in mending bones by providing a compressive force that facilitates bone knitting. Additionally, the central portion of the inflatable device may be inflatable such that an outward pressure is applied to the fractured bone to improve bone stability, shape, and/or healing.  
      Referring to  FIG. 36 , one version of an inflatable device  2802  is depicted having a first portion  2804  and a second portion  2806  shown inserted into a fractured bone  2700 . The illustrated bone is shown with a first bored or bullet-shaped cavity  2706  and a second bored or bullet shaped cavity  2708  formed in a first bone portion  2702  and a second bone portion  2704 , respectively. The cavities  2706 ,  2708  may be formed in any suitable configuration, such as in a dumbbell shape, a straight bore, or a bullet shape, via access holes  2710 ,  2711 , or the like, and may be created with a bone cutter or any other suitable device. It will be appreciated that the cavities may be formed via one or a plurality of access points or by any other suitable mode.  
      In one version, the inflatable device  2802  is inserted into an access hole  2710 , through the second bone portion  2704 , and at least partially into the first bone portion  2702 . Once inserted, the first portion  2804  of the inflatable device  2802 , which may be a substantially cylindrical balloon portion, may be inflated to engage the inner surface of the first bone portion  2702 . The inflation may be accomplished via a first tube  2820 , cannulated member, lumen, rod, tether, or the like, where the first tube  2820  passes through the second portion  2806  of the inflatable device  2802  and extends out of the inflatable device  2802  through the access hole  2710 . In one version, the first tube is configured to pass around the outer perimeter of the second portion of the inflatable device where, for example, the second portion of the balloon does not have a central bore therethrough. It will be appreciated that any suitable arrangement or configuration of tubes, tethers, inflatable devices, balloons, and/or balloon portions is contemplated. The arrangement may be configured to provide stabilization of the bone segments such that they do not compress and collapse the bone.  
      Referring to  FIG. 37 , after inflation of the first portion  2804  of the inflatable device  2802 , the first tube  2820  may be pulled or urged proximally in the direction of the access point  2710  such that the first bone portion  2702  engages and/or compresses the second bone portion  2704 . After coupling the bone portions  2702 ,  2704 , the second portion  2806  of the inflatable device  2802 , which may be a substantially cylindrical balloon portion sharing at least one face with the first portion  2804  of the inflatable device  2802 , may be inflated. The second portion  2806  of the inflatable device  2804  may be inflated by a second tube  2822 , or the like, such that the inner surface of the fractured bone  2700  is compressed to increase bone stability, or for any other suitable therapeutic benefit.  
      Providing an inflatable device with at least two chambers, cavities, sections, or the like, may allow various therapeutic functions to be accomplished with a single balloon. For example, as illustrated in  FIG. 37 , the first portion  2804  of the inflatable device  2802  may be used to grab and axially urge the first bone portion  2702  into contact with the second bone portion  2704 . Following this connection or joining of the bone portions  2702 ,  2704 , the second bone portion  2806  may be used to stabilize the bone radially by expanding outward against the inner wall of the bone. Inflating both portions  2804 ,  2806  of the inflatable device  2802  may allow an axial load and a lateral or radial compressive load to be applied to a bone simultaneously. Such a combination may speed the healing process and may facilitate returning the bone to the original anatomical form. It will be appreciated that any suitable number of chambers having any suitable configuration may be provided in an inflatable device. Multiple chambered inflatable devices with multiple shared or independent lumens are contemplated. A plurality of inflatable devices each having multiple chambers are contemplated. The relationship between inflatable devices, portions of inflatable devices, or combinations thereof, may provide stabilization of the bone segments so that they do not compress and collapse the bone.  
      It will be appreciated that versions herein have been shown in relation to a long bone, but that versions of the balloon may be configured for any suitable orthopedic application including vertebrae of the spine, the femur, the tibia, the ulna, the radius, or any other suitable bone. While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.