Abstract:
A device for delivering a material to an orthopedic target site is disclosed. The device can be used to deliver bone cement to an intra-vertebral site. The device can have a pusher rod within a tube. The tube can be loaded with the bone cement distal to the pusher rod. The pusher rod can have varying rigidity along the length of the pusher rod. The tube and pusher rod can navigate tortuous pathways from a percutaneous or transcutaneous insertion en route to the target site or to improve extracorporeal ergonomics. Methods for using the same are also disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Application No. 61/411,778, filed 9 Nov. 2010, which is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    Devices and methods for a delivering a material into an orthopedic target site are disclosed. For example, devices and methods for delivering bone cement to a vertebral body are disclosed. 
         [0004]    2. Description of Related Art 
         [0005]    It is common during orthopedic medical procedures to place materials in the bone. For instance, in vertebroplasty, bone cement is injected to stabilize a vertebral compression fracture. Similarly, in kyphoplasty, a balloon is first inserted into a vertebral body and inflated to create a void. The void is then filled with bone cement. 
         [0006]    Some devices for moving bone cement consist of a hand pump and a flexible tube. The tube is inserted into the orthopedic structure and bone cement is pumped through the tube and into the structure. The tube is long enough that the pump may be located up to several feet from the injection site. These devices have the advantage of allowing the physician to be removed from the injection site such that he or she is not exposed to the x-rays used to guide the filling procedure. However, tactile feedback is poor, excessive pressures can be generated and the bone cement remaining in the tube is all wasted in the end. Detaching the tube from the mass of injected bone cement can also be problematic. 
         [0007]    Some devices, such as those used for kyphoplasty, use a simple rigid hollow tube with a solid rigid pusher rod that slides down the tube. The hollow tube is filled with bone cement and the solid pusher rod drives the bone cement into the body. These devices have the advantage of excellent tactile feedback, simplicity, lack of waste and easy termination with the mass of injected bone cement. However, they have small volumes and, because they are used right at the injection site, may expose the physician to x-rays during the filling procedure. Finally, because of their material choices, they may require significant force to extrude cement as the cement hardens. 
         [0008]    What is needed is a device to place material into bone that protects physicians from X-ray exposure, has adequate volume, smooth operation, good haptics, minimizes waste and allows easy termination with the mass of injected bone cement. 
       SUMMARY OF THE INVENTION 
       [0009]    A device for delivering a material into an orthopedic target site is disclosed. The device can have a flexible tube having a first lumen having a first end and a second end. The first lumen can extend along all or part of the length of the flexible tube. The device can have a pusher having a pusher total length. The pusher can have a pusher first length along and a pusher second length. The pusher first length can abut or contact the pusher second length. The pusher first length can have a first rigidity. The pusher second length can have a second rigidity. The first rigidity can be less than or greater than the second rigidity. The pusher and tube can be configured for the pusher to be slidably received by a port at the proximal end of the first lumen. The material to be delivered can be located in the first lumen between the pusher and the distal end of the flexible tube. 
         [0010]    The pusher first length can be at least about 10% of the pusher total length. The pusher second length can be at least about 10% of the pusher total length. 
         [0011]    The material can be or have a bone cement. The flexible tube can have a low friction material configured to resist binding to the bone cement. 
         [0012]    The flexible tube can be translucent and/or transparent. The flexible tube can have a second lumen along all or part of the length of the flexible tube. The pusher second length can have a cable. 
         [0013]    A method for delivering a material into an orthopedic target site is disclosed. The method can include slidably positioning a pusher into a first lumen of a flexible tube. The first lumen can have a first port and a second port. The pusher can have a pusher first length and a pusher second length. The pusher first length can be more rigid or less rigid than the pusher second length. The method can include loading the first lumen with the material between the pusher second length and the second port. The method can include positioning the flexible tube so the flexible tube is configured to have at least a first curve, for example to navigate around an anatomical obstruction. Positioning the flexible tube can include the second port being located at the orthopedic target site. The method can include moving the pusher from a first pusher position to a second pusher position. Moving the pusher from the first pusher position to the second pusher position can include moving the pusher second length across the first curve. The method can include deploying the material from the lumen to the orthopedic target site. 
         [0014]    The deploying of the material is concurrent with the moving of the pusher from the first pusher position to the second pusher position. The material to be delivered to the orthopedic target site can be or have a bone cement. 
         [0015]    The method can include stopping a flow of the material. The stopping of the flow can include ceasing a translational movement of the pusher with respect to the flexible tube. 
         [0016]    The method can include removing the flexible tube from the orthopedic target site. The method can include creating a void at the orthopedic target site. 
         [0017]    The method can include positioning a cannula at the orthopedic target site. The cannula can have a cannula distal port open to the orthopedic target site once the cannula is positioned. Positioning the flexible tube can include moving the flexible tube through the cannula, for example, until the distal port of the flexible tube exits the cannula distal port. 
         [0018]    A method for delivering a material into an orthopedic target site is disclosed. The method can include positioning a device at the orthopedic target site. The pusher or advancement rod can have an advancement rod first length and an advancement rod second length. The advancement rod first length can have a different rigidity than a rigidity of the advancement rod second length. The method can include advancing the advancement rod from an advancement rod proximal position to an advancement rod distal position. During the advancing of the advancement rod, the first length of the advancement rod can be non-collinear with the advancement rod second length. The method can include deploying the material from the device to the orthopedic target site. 
         [0019]    The material can be deployed preceding, subsequent to, concurrent with, or combinations thereof, the advancing of the advancement rod. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]      FIG. 1  illustrates a variation of a void creation tool. 
           [0021]      FIG. 2   a  illustrates a variation of the material delivery device. 
           [0022]      FIGS. 2   b  and  2   c  are cross-sections B-B and C-C, respectively, of a variation of the device. 
           [0023]      FIGS. 2   d  and  2   e  are cross-sections B-B and C-C, respectively, of a variation of the device. 
           [0024]      FIG. 3  illustrates a variation of the device dissembled. 
           [0025]      FIG. 4  illustrates a variation of the delivery device inner assembly in a curved configuration. 
           [0026]      FIG. 5  illustrates a variation of the delivery device outer assembly in a curved configuration. 
           [0027]      FIG. 6  is a close-up cross-section of a length of the device. 
           [0028]      FIG. 7  is a close-up view of a length of a variation of the device. 
           [0029]      FIG. 8  is a close-up view of a length of a variation of the proximal end of the device. 
           [0030]      FIG. 9  is a close-up view of a length of a variation of the distal end of the device. 
           [0031]      FIGS. 10A through 10E  illustrate variations of cross-section A-A. 
           [0032]      FIGS. 11   a  and  11   b  are close-up, phantom views of variations of the distal end of the device. 
           [0033]      FIGS. 12   a  and  12   b  illustrate a variation of a method for controllably closing the distal end of the device. 
           [0034]      FIGS. 13   a  and  13   b  illustrate a variation of a method for controllably closing the distal end of the device. 
           [0035]      FIGS. 14   a  and  14   c  illustrate a variation of a method for controllably opening and closing the distal end of the device. 
           [0036]      FIG. 15  is a sagittal section of a patient including a full view of a spine. 
           [0037]      FIG. 16  is a close-up transverse section of a patient including a vertebra and the adjacent nerves including the spinal cord. 
           [0038]      FIGS. 17A through 17   i  illustrate a method for creating one or more voids at a target site within a vertebral body, filling the voids with a filler material such as bone cement, and withdrawing surgical tools for creating the voids and delivering the filler material from the target site. 
           [0039]      FIG. 18  is a graph showing pressure verse diameter for variations of balloons including burst pressures. 
           [0040]      FIGS. 19 and 20  illustrate methods for using the delivery device. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]      FIG. 1  illustrates that an inflation system  470  can have an expandable void-creation volume such as balloon  20  that can be inflated by pushing inflation fluid, such as water, saline, a gel or dye, from the syringe  472 , into the inflation port  482 , through the hollow shaft lumen  154  and into the balloon  20 . The syringe  472  can be detachable or non-detachable from the remainder of the inflation system  470 . 
         [0042]    The stiffening rod  474  can be removed from the inflation system  470  or left in place to stiffen the inflation system  470  while positioning the balloon  20  in the body. The stiffening rod tip  484  can have atraumatic geometry, or a soft plastic or elastomeric tip that will minimize puncture or damage the distal end of the balloon. The inflation system  470  can have a stiffening rod control  480 , for example a knob or handle on the proximal end of the inflation system  470  to control the position of the stiffening rod  474 . A seal  286  adjacent to the stiffening rod control can prevent pressure from escaping from the hollow shaft lumen. When the balloon  20  is at the target site, the stiffening rod  474  can be removed from the inflation system or left in place. 
         [0043]      FIG. 2   a  illustrates a delivery service or system that may be used to deliver a material, such as one or more bone cements, morselized bone, or combinations thereof, into the body. Cement delivery device  996  may be comprised of cement delivery device outer assembly  1000  and cement delivery device inner assembly  1008 . Inner assembly  1008  may be inserted into outer assembly  1000  such that the inner assembly  1008  can slide relative to the outer assembly  1000 . 
         [0044]      FIG. 3  shows that the cement delivery device outer assembly  1000  may comprise outer assembly tube  1002 , outer assembly handle  1004 , outer assembly tube end  1006  with an outer assembly tube end length  1007  and bone cement filling fitting  1032 . Outer assembly tube  1002  may be comprised of a low-friction material such as PTFE, LDPE or the like. For instance, tube  1002  may be made of a material that has a dynamic coefficient of friction with steel of less than 0.3, more narrowly less than 0.2, still more narrowly less than 0.1. The low-friction material can resist binding to the bone cement. 
         [0045]    Outer assembly tube  1002  may be flexible, rigid, semi-flexible, or combinations thereof, for example alternating along the length of the outer assembly tube  1002 . Outer assembly tube  1002  may be opaque, clear, transparent, translucent or combinations thereof. Outer assembly tube  1002  may comprise a fiber reinforcement element, such as a braid. This fiber reinforcement element may increase radial stiffness when the tube  1002  is pressurized. Outer assembly tube  1002  may have an outer diameter of less than about 0.32 inches (8.1 mm), more narrowly less than 0.2 inches (5 mm). Outer assembly tube  1002  may have a length of 12-32 inches (304-813 mm). Outer assembly tube  1002  may have about a 0.138 inch (3.50 mm) outer diameter and about a 0.108 inch (2.74 mm) inner diameter and about a length of 20 inches (508 mm). 
         [0046]      FIG. 3  shows that the cement delivery device inner assembly  1008  may comprise an inner assembly pushing device  1014  and an inner assembly handle  1012 . Pusher, advancement rod, or inner assembly pushing device  1014  may comprise a pushing device rigid portion  1020  with a pushing device rigid portion length  1028 , and a pushing device flexible portion  1016  with a pushing device flexible portion length  1024  and a pushing device flexible portion tip  1018 . 
         [0047]    The pushing device rigid portion length  1028  can be about 10% or more, or yet more narrowly greater than or equal to about 25%, for example about 65% of the entire length of the inner assembly pushing device  1014 . The pushing device flexible portion length  1024  can be about 10% or more, or, yet more narrowly greater than or equal to about 25%, or for example about 35% of the entire length of the inner assembly pushing device  1014 . The pushing device rigid portion length  1028  and the pushing device flexible portion length  1024  can combine to be about the entire length of the inner assembly pushing device  1014 . 
         [0048]    The pushing device rigid portion  1020  can abut, be integral with, or contact the pushing device flexible portion  1016 . For example, the pushing device flexible portion  1016  can be a cable fused, hound, clipped, wedged into a port in the distal end of the pushing device rigid portion  1020 , or combinations thereof. 
         [0049]    The pushing device rigid portion  1020  may be a rod or a tube or a semi-rigid cable with an outside diameter of about 0.050-0.090 inches (1.27-2.29 mm). The pushing device rigid portion length  1028  may be about 7-15 inches (178-381 mm). The pushing device flexible portion  1016  may be a semi-rigid cable or semi-flexible cable with a diameter of about, 0.040-0.080 inches (1.02-2.03 mm), more narrowly 1/16 of an inch (1.59 mm). The pushing device flexible portion  1016  may be attached to the pushing device rigid portion  1020  by a bond, a crimp, a weld, a braze or some combination thereof. The pushing device flexible portion length  1024  may be about 1-7 inches (25-178 mm). The pushing device flexible portion tip  1018  may be comprised of an additional short section of tubing, a tightly bonded termination of the cable, a crimp fitting, or combinations thereof. The pushing device flexible portion  1016  may be omitted entirely from the inner assembly pushing device  1014 . 
         [0050]      FIGS. 2   b  and  2   c  illustrate a variation of cross-sections B-B and C-C respectively.  FIG. 2   b  illustrates that the tube  1002  can have a lumen  1100 . The tube  1002  can have multiple, separated lumens. The lumen  1100  can extend all or a part of the length of the tube  1002 . Along the pushing device rigid portion length  1028  the pushing device rigid portion  1020  of the inner assembly  1008  can have a uniform solid or hollow circular cross-section.  FIG. 2   c  illustrates that along the pushing device flexible portion length  1024 , the pushing device flexible portion  1016  of the inner assembly  1008  can be porous, woven and/or braided, for example, as a cable. 
         [0051]    The diameter of the pushing device rigid portion  1020  can be greater than, equal to, or less than the diameter of the pushing device flexible portion  1016 . The gap between the radially inner surface of the tube  1002  and the radially outer surface of the pushing device rigid portion  1020  and/or the pushing device flexible portion  1016  can be nominal (e.g., sufficient to allow sliding), or large enough to allow deployment delivery of bone cement or other materials through the gap. 
         [0052]      FIGS. 2   d  and  2   e  illustrate a variation of cross-sections B-B and C-C respectively.  FIG. 2   d  illustrates that along the pushing device rigid portion length  1028  the pushing device rigid portion  1020  of the inner assembly  1008  can have a circular cross-section or cylindrical core  1102 . The core  1102  can be radially surrounded by a solid or cabled stiffening sheath  1104 . The core  1102  can have a smaller radius than the stiffening sheath  1104 . The core can be made from the same material  1102  or a different material than the sheath  1104 .  FIG. 2   e  illustrates that along the pushing device flexible portion length  1024 , the pushing device flexible portion  1016  of the inner assembly  1008  can have the core  1102 , for example unsurrounded by the stiffening sheath  1104 . 
         [0053]      FIG. 4  shows that flexible portion  1016  may be bent to form an angle  1092  by applying a force  1088  normal to the longitudinal axis of flexible portion  1016  using, for instance, operator hand  1084 . Angle  1092  may be greater than about 45 degrees, more narrowly greater than about 90 degrees. Force  1088  may be less than 30 newtons, more narrowly less than 15 newtons, more narrowly less than 5 newtons, still more narrowly less than 2.5 newtons For instance, pushing device flexible portion length may  1024  may be about 3 inches long, force  1088  may be about 1 newton and angle  1092  may be about 90 degrees. Applying and then removing force  1088  to flexible portion  1016  may not result in any significant permanent deformation in the shape of flexible portion  1016 . 
         [0054]    The flexible portion  1016  can be straight and/or bend having a radius of curvature of greater than or equal to about 4 in., more narrowly about 3 in, yet more narrowly about 1 in. The tube  1002 , for example along the length at which the flexible portion  1016  is positioned, can curve to a radius of curvature about equal to the radius of curvature of about the radius of curvature of the flexible portion  1016 , e.g., being straight, having a radius of curvature of greater than or equal to about 4 in., more narrowly about 3 in, yet more narrowly about 1 in. 
         [0055]      FIG. 5  shows that outer assembly  1000  can be flexible. For instance, tube  1002  can be deformed into a circle without any significant permanent deformation. 
         [0056]      FIG. 6  shows the pushing device flexible portion  1016  and the pushing devise flexible portion tip  1018  sliding within outer assembly tube  1002 . As shown, pushing device flexible portion  1016  and the pushing device flexible portion tip  1018  may be visible through the walls of outer assembly tube  1002 . 
         [0057]      FIG. 7  shows that outer assembly tube  1002  may be made in a curved or spiral shape. Outer assembly tube  1002  may comprise a tube reinforcement spring  1036  wrapped around the outside diameter of the tube. Spring  1036  may make tube  1002  stiffer and/or give tube  1002  a higher burst pressure. 
         [0058]      FIG. 8  shows outer assembly handle  1004  and bone cement filling fitting  1032  attached to outer assembly tube  1002 . Bone cement filling fitting  1032  may be, for instance, a luer fitting. 
         [0059]      FIG. 9  shows a possible configuration of the outer assembly tube end  1006 . Tube end  1006  may be a fitting with a smaller inside diameter than outer assembly tube  1002 . Tube end  1006  can be a straight rigid tube. Outer assembly tube end  1006  may be made of a material that bonds well to bone cement. For instance, it could be made of a metal, or a porous material that bone cement may flow into. 
         [0060]      FIGS. 10A-E  show variations of cross-section A-A of outer assembly tube end  1006 . Tube end  1006  can have one or more vanes  1040  that extend over all or part of the length  1007  of tube end  1006 . The vanes can furcate (e.g., bifurcate, trifurcate, quadfurcate) the tube end  1006  or entire tube  1008  into multiple lumens. Vanes  1040  maybe made of a material that forms a strong bond with bone cement. Vanes  1040  may increase the area available for bone cement to bond in tube end  1006 , thus increasing bond strength. Tube end  1006  may be solid except for holes  1042  that pass lengthwise through end  1006 . For instance, tube end  1006  may have 1, 2, 3, 4, 5, more than 5, more than 10 or more than 50 lengthwise holes  1042 . Each hole  1042  can be in fluid communication with a single lumen in the tube or each hole  1042  can be in communication with separate lumens in the tube. 
         [0061]      FIGS. 11   a  and  11   b  show tube  1002  with tube end  1006 . Tube end  1006  is, for instance, a plug which half covers the exits of tube  1002 . Inner tube  1076  is sized to pass thru the inner diameter of tube  1002  and has and end plug which covers about half the exit of inner tube  1076 . In one rotational orientation of inner tube  1076 , shown in  FIG. 11   a , material may exit tube  1002  at tube end  1006 . In a second rotational orientation of inner tube  1076 , shown in  FIG. 11   b , material is blocked from exiting tube  1002 . By rotating inner tube  1076  within tube end  1006 , the distal end of tube  1002  may be closed. This closing may serve to sever tube end  1006  from the material immediately distal to tube end  1006 . 
         [0062]      FIGS. 12   a - 12   b  shows a material flow valve  1048 . The valve  1048  may consist of a circular flapper mounted on a pivot. In  FIG. 12   a , the flapper is turned vertically allowing material to flow. In  FIG. 12   b , the flapper is turned horizontally, stopping the flow of material. 
         [0063]      FIGS. 13   a - 13   b  show that outer assembly tube  1002  can be circumferentially closed by pulling cable  1044 . 
         [0064]      FIGS. 14   a - 14   c  show a material flow valve that is activated passively. In  FIG. 14   a , bone cement  445  is flowing towards cement flow valve  1048 . In  FIG. 14   b , the bone cement  445  has reached cement flow valve  1048  and the back pressure on the bone cement  445  has caused cement flow valve  1048  to open. In  FIG. 14   c , the back pressure on the bone cement  445  is now not sufficient to hold cement flow valve  1048  open and it closes automatically. 
         [0065]      FIG. 15  illustrates a sagittal view of a patient and the spine  406 . The spine  406  can have vertebrae  408  and cervical, thoracic, lumbar and sacral regions  410 ,  412 ,  414 , and  416 . The device  470  and  996  can be used in or between vertebrae  408  in any region of the spine  406 . 
         [0066]      FIG. 16  illustrates a vertebrae  408  that can have cortical bone  418  and cancellous bone  420 . The vertebrae  408  can have a vertebral body  422  a vertebral process  424  and pedicles  426 . 
         [0067]      FIGS. 17A through 17   i  illustrate a method for deploying balloons  20  bilaterally, for example including one balloon inserted through each of opposing pedicles  426   a  and  426   b.    
         [0068]      FIG. 17A  illustrates that a first delivery tube  428   a , such as a cannula, can be placed through the left pedicle  426   a . The delivery tube  428  may have a inside diameter of less than about 6 mm, more narrowly from about 2 mm to about 4.5 mm. A bone drill can be passed through the delivery tube to form a first drill void  430   a  on the left side of the vertebral body. A second delivery tube  428   b  can be through the right pedicle  426   b . A second drill void  430   b  can be formed on the left side of the vertebral body. 
         [0069]      FIG. 17B  illustrates that a first balloon  20   a  can be inserted into the left side of the vertebral body through the first delivery tube  428   a . A second balloon  20   b  can be inserted into the right side of the vertebral body through the second delivery tube  428   b . The balloons  20   a  and  20   b  may be part of an inflation system  470 , such as that shown in  FIG. 1 . 
         [0070]      FIG. 17C  illustrates that fluid pressure can be delivered, as shown by arrow  438 , through the hollow shaft  2000  to the balloon  20 . The balloon  20  can inflate and expand, as shown by arrows  440   a  and  440   b . The expanding balloon can compress the cancellous bone surrounding the drill void, creating a larger balloon void  442 . The first and second balloons can form a first void segment  454   a  and a second void segment  454   b , respectively, of the balloon void  442 . The void segments  454  may overlap, as shown. The void segments  454  may be separate. 
         [0071]      FIG. 18  illustrates that the diametric elasticity of existing medical inflatable devices can be approximately 0.06 in/ATM and that a typical burst pressure can be about 3 ATM. Balloon  20  can have an exemplary diametric elasticity of 0.0004 in./ATM and a burst pressure above 20 ATM (290 psi). For example, the burst pressure can be from about 290 psi to about 1500 psi. More narrowly, the burst pressure can be from about 500 psi to about 1000 psi. For example, the burst pressure can be about 500 psi, about 750 psi, about 1000 psi, about 1500 psi, or higher than 1500 psi. For example, the burst pressure can be greater than 4 ATM with a diameter of greater than 20 mm, with a diametric compliance of less than about 15%, or less than about 10% or less than 5%. 
         [0072]      FIG. 17D  illustrates that the second balloon  20   b  can be deflated, contracted and removed from the balloon void. 
         [0073]      FIG. 17E  illustrates that a second cement conduit  444   b  can be inserted through the second delivery tube  428   b  and into the second void segment  454   b . Bone cement  445  can be delivered through the second cement conduit  444   b  and into the second void segment  454   b . Cement conduits  444   a  and  444   b  may each be equivalent to outer assembly tube  1002 . 
         [0074]      FIG. 17F  illustrates that the bone cement  445  can fill the second void segment  454   b  and/or contact the first balloon  20   a . The second cement conduit  444   b  can be removed from the balloon void. The bone cement delivered to the second void segment can cure. The first balloon  20   a  may not erode, decay or bond to the cement. 
         [0075]      FIG. 17G  illustrates that the first balloon  20   a  can be deflated, contracted and withdrawn from the first void segment  454   a.    
         [0076]      FIG. 17H  illustrates that a first cement conduit  444   a  can be inserted through the first delivery tube  428   a  and into the first void segment  454   a . Bone cement  445  can be delivered through the first cement conduit  444   a  and into the first void segment  454   a.    
         [0077]      FIG. 17   i  illustrates that the first and second delivery tubes  428  can be removed from the patient. The balloon voids  454   a  and  454   b  can be substantially filled with bone cement  445 . The bone cement  445  can cure. 
         [0078]    The procedure described in  FIGS. 17   a  to  17   i  and  FIG. 18  may also be performed with the omission of one of the two delivery tubes  428  and wherein only a single void  454  is created with one balloon  20  using access through the remaining tube  428 . 
         [0079]    Cement delivery device outer assembly  1000  may be filled with uncured bone cement by injecting it from, for instance, a syringe attached to bone cement filling fitting  1032 . Cement delivery device inner assembly  1008  may be inserted into cement device outer assembly  1000  such that advancing the inner assembly causes bone cement to be expelled at outer assembly tube end  1006 . The design of outer assembly tube  1002  (such as, for instance, the choice of low friction materials) may make the movement of bone cement particularly smooth and easy, regardless of the state of cure of the bone cement. For instance, advancing inner assembly handle  1012  may require from 2-8 lbs of force. Outer assembly tube  1002  may not bond at all to bone cement as it cures. Tip  1018  may fit the inside diameter of outer assembly tube  1002  such that the tip can move freely forward without allowing any bone cement to pass around the tip  1018 . 
         [0080]      FIGS. 19 and 20  show a method for placing material in the body, for instance for placing bone cement  445  in a vertebral body  422 . The bone cement  445  to be deployed from the cement delivery device  996  can be loaded into the device  996  between the distal end of the flexible portion  1016  and/or the tip  1018  and the distal port at the distal end of the device  996 . 
         [0081]    As shown in  FIGS. 19 and 20 , the cement delivery device  996  may be inserted through a cannula or delivery tube  428 . The distal end of the device outer assembly  1000  can exit the distal end of the delivery tube  428  into the target site of the void  442 . C-arm head  1080  may produce imaging x-rays for use by an operator during the procedure. Operator hands  1084  may not be in the direct x-ray path. The tube  1002  can be configured to have a curve, such as a 90° turn, while in the patient and/or outside the patient after the tube  1002  exits the patient. The tube  1002  can turn away from the C-arm head  1080 , for example enabling a user (e.g., physician) to use the device to insert the bone cement  445  into the patient without exposing, or minimizing exposure of, the energy (e.g., radiation) emitted from the head  1080 . 
         [0082]    In  FIG. 19 , a portion of cement  445  has been placed into void  442  by translatably, slidably advancing the device inner assembly  1008  with respect to the device outer assembly  1000 . Tip  1018 , flexible portion  1016  and rigid portion  1020  may be visible to the operator through tube  1002 . Flexible portion  1016  has no significant bend in  FIG. 19 . 
         [0083]    In  FIG. 20 , inner assembly  1008  has been advanced distally from the position shown in  FIG. 19 . Flexible portion  1016  can be bent around a curve (e.g., for ergonomic improvement and/or to keep the user&#39;s hands clear of energy emitted by the C-arm head  1080 , and/or to navigate around an anatomical obstacle in vivo) in tube  1002 . Tip  1018  may not enter delivery tube  428 . The assembly may be held as shown in  FIG. 20  until the bone cement cures. Tube end  1006  may be broken free (for instance, by twisting or bending). The design of tube end  1006 , such as described supra, may give a very strong bond with the cone cement in tube end  1006 . This bond may make it easier to break tube end  1006  free. Cement delivery device  996  and delivery tube  428  may be removed. 
         [0084]    The internal volume of tube  1002  may contain sufficient bone cement to fill one third of the void  442  in a vertebral body, more narrowly one half of the void  442 , still more narrowly all of the cavity in a vertebral body. Inner assembly handle  1012  may give a precise haptic feedback to the user about pressure in the void  442  while bone cement  445  is being placed in the void  442 . 
         [0085]    U.S. patent application Ser. Nos. 12/537,166, filed 6 Aug. 2009; and 12/477,057, filed 2 Jun. 2009 are incorporated by reference herein in their entireties. 
         [0086]    Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one), and plural elements can be used individually. Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The term “comprising” is not meant to be limiting. The above-described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.