STEERABLE AND CURVABLE VERTEBROPLASTY SYSTEM WITH CLOG-RESISTANT EXIT PORTS
Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. The distal end may be provided with one or two or more cavity creation elements, such as a bevel or diamond tip or inflatable balloons. A cavity creation element may include one or more filament layers. Systems are also disclosed, including the steerable and curvable injection needle, introducer and stylet. The system can also include various exit ports that can be configured with clog-resistant features. Methods are also disclosed.
1 .- 10 . (canceled)
11 . A method for treating a bone, comprising:
creating a pedicular access channel in a pedicle to access the interior of a vertebral body;
inserting an introducer cannula into the pedicle;
inserting a steerable injection needle through the introducer cannula into the interior of a vertebral body, the steerable injection needle having a proximal end, a tubular body having a longitudinal axis, and a distal end, a control for controlling deflection of the distal end, and an input port having a longitudinal axis and configured to receive bone cement, wherein the control is positioned proximally to the input port, wherein the longitudinal axis of the input port is not coaxial with the longitudinal axis of the tubular body, wherein the distal end has a first configuration substantially coaxial with the longitudinal axis of the tubular body, wherein the distal end comprises a closed distal-facing surface and a lateral-facing surface comprising an exit aperture in connection with a central lumen, the exit aperture defined by a first angled surface and a second angled surface, the first angled surface opposing and being non-parallel to the second angled surface;
adjusting the control to deflect the distal end of the steerable injection needle to a second configuration that is not substantially coaxial with the longitudinal axis of the tubular body; and
flowing bone cement through the steerable injection needle, out the exit aperture and into the interior of the vertebral body.
12 . The method of claim 11 , wherein the exit aperture has a first inner axial dimension at a junction with the central lumen and a second outer axial dimension where bone cement exits the needle, wherein the second axial dimension is greater than the first axial dimension.
13 . The method of claim 11 , wherein the first angled surface has a longitudinal axis and the second angled surface has a longitudinal axis, wherein the longitudinal axis of the first angled surface and the longitudinal axis of the second angled surface intersect and form an angle of between about 30 degrees and 150 degrees.
14 . The method of claim 11 , wherein the longitudinal axis of the first angled surface and the longitudinal axis of the second angled surface intersect and form an angle of between about 60 degrees and 120 degrees.
15 . The method of claim 11 , wherein the distal end comprises an end cap operably attached to the tubular body.
16 . The method of claim 11 , wherein the distal end comprises a zone having a radially inwardly tapering diameter.
17 . A steerable vertebroplasty device, comprising:
an elongate, tubular body having a proximal end, a distal end, a central lumen extending therethrough, and an opening on the distal end;
a deflectable zone on the distal end of the tubular body, deflectable through an angular range, the deflectable zone having a proximal portion and a distal portion, wherein the elongate tubular body has a first longitudinal axis extending from the proximal end to the proximal portion of the deflectable zone, wherein the deflectable zone is movable from a first substantially straight configuration in an unstressed state to a second deflected configuration;
a handle on the proximal end of the tubular body;
a deflection control on the handle actuated by rotation about the first longitudinal axis of the tubular body, wherein upon rotation of the deflection control a proximally directed force is exerted on a movable actuator attached to the tubular body to actively change the curvature of a distal portion of the tubular body;
an input port for receiving bone cement, the input port having a second longitudinal axis spaced apart from and at an angle with respect to the first longitudinal axis, the input port positioned distally on the elongate, tubular body relative to the deflection control; and
a cavity creating element carried by the deflectable zone, having a first layer and a second layer, wherein the second layer comprises a filament layer.
18 . The steerable vertebroplasty device of claim 17 , wherein the cavity creating element comprises a balloon.
19 . The steerable vertebroplasty device of claim 18 , wherein the balloon has a first compliance value when inflated to a first volume at a first pressure without being substantially constrained by the filament layer, wherein the balloon has a second compliance value when inflated to a second volume at a second pressure while being constrained by the filament layer, wherein the second volume is greater than the first volume, wherein the second compliance value is at least about 10% less than the first compliance value.
20 . A steerable and curvable system for delivering a hardenable media to an injection site, comprising:
a handle;
a deflection adjustment control on the handle; and
an elongate tubular body connected to the handle having a proximal end and a distal end, the distal end including a deflectable portion capable of deflection within an angular range, the degree of deflection controllable by the adjustment control;
wherein the elongate tubular body has a distal port and a proximal port in communication via a central lumen; and
an obturator removably carried by the central lumen.