AU2017204475A1 - Steerable vertebroplasty system with cavity creation element - Google Patents

Abstract

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 a cavity creation element, such as an inflatable balloon. Systems are also disclosed, including the steerable injection needle, introducer and stylet. The system may additionally include a cement delivery gun, one-time use disposable cement cartridges and a cement mixing chamber. Methods are also disclosed. 31a

Description

2017204475 30Jun2017

STEERABLE VERTEBROPLASTY SYSTEM WITH CAVITY

CREATION ELEMENT

This application is a divisional of Australian Application No. 2014271326, the entire contents of which are incorporated herein by reference.

[0001] This application is a continuation-in-part of U.S. Patent Application No. 11/941,764 filed November 16, 2007, the disclosure of which is incorporated by reference herein in its entirety.

[0002] The present invention relates to bone augmentation devices and procedures. In particular, the present invention relates to steerable injection devices and systems for introducing conventional or novel bone cement formulations such as in performing vertebroplasty.

BACKGROUND OF THE INVENTION

[0003] According to the National Osteoporosis Foundation ten million Americans have osteoporosis, and an estimated 34 million with low bone mass are at risk of developing osteoporosis fhtto://www.nof.org/osteoporosis/diseasefacts.htm'>. Called the “silent disease,” OSP develops slowly over a number of years without symptoms. Eighty percent of those affected are women, particularly petite Caucasian and Asian women, although older men and women of all races and ethnicities are at significant risk.

[0004] In the United States, 700,000 people are diagnosed with vertebral compression fractures as a result of OSP each year. Morbidity associated with vertebral fractures includes severe back pain, loss of height and deformity, all of which negatively affect quality of life.

[0005] Once microfracture of the vertebra begins, there is little the clinician can do except palliative medical treatment using analgesics, bed rest and/or restriction of activity. With time, the microfractures widen at one level and without surgical intervention, the fractures cascade downward with increasing kyphosis or “hunching” of the back. Once a mechanical lesion develops, surgery is the only option. Vertebroplasty or kyphoplasty are the primary minimally-invasive surgical procedures performed for the treatment of compression-wedge fractures due to OSP. -1- PCT/US2008/083698 WO 2009/065085 2017204475 30Jun2017 [0006] Vertebroplasty stabilizes the collapsed vertebra by injecting polymethylmethacrylate (PMMA) or a substantially equivalent bone cement into cancellous bone space of the vertebrae. Besides providing structural support to the vertebra, the exothermic reaction of PMMA polymerization is said to kill off the nociceptors or pain receptors in the bone, although no proof of this hypothesis has been provided in the literature. This procedure is typically performed as an outpatient procedure and requires only a short-acting local or general anesthetic. Once the surgical area of the spine is anesthetized, the physician inserts one or two needles through small skin incisions into either the pedicle (uni-transpedicular) or the pedicles of the vertebral body i.e.5 bi-transpedicular. PMMA is injected through the needle and into the cancellous-bone space of the vertebra.

[0007] Kyphoplasty mirrors the vertebroplasty procedure but has the additional step of inserting and expanding a nylon balloon in the interior of the vertebral body. Expansion of the balloon under pressure reduces the compression fracture and creates a cavity. After withdrawal of the balloon, PMMA is injected into the cavity to stabilize the reduction. The kyphoplasty procedure may restore the vertebral body height. Kyphoplasty is an in-patient surgery that requires hospitalization and a general anesthetic. Kyphon Inc. claims over 275,000 spinal fractures have been treated using their PMMA derivative and their “balloon” kyphoplasty procedure worldwide (Sunnyvale, Calif., September 5,2006, (PR NEWS WIRE) Kyphon study 2006).

[00Q8] Bone cement for both vertebroplasty and kyphoplasty procedures currently employ variations of standard PMMA in a powder and a methyl methacrylate monomer liquid. When the powder and liquid monomer are mixed, an exothermic polymerization takes place resulting in the formation of a “dough-like” material, which is then inserted into the cancellous bone space. The dough, when hardened, becomes either the reinforcing structure or the grout between the bone and prosthesis.

[0009] The average clinical in vivo life of the PMMA grout is approximately 10 years due to corrosion fatigue of either the bone-cement/prosthesis and/or the bone cement/bone interfaces. Jasty et al, (1991) showed that in cemented total hip replacements: “Fractures in the cement mantle itself were found on cut sections around all prosfheses which had been in use for over three years.” Jasty et al. also noted: “In general, specimens less than -2- PCT/US2008/083698 WO 2009/065085 2017204475 30 Jun2017 10 years in situ showed small incomplete fractures while the specimens in place more than 10 years all showed large complete cement mantle fractures.” [0010] When an implant fails, a revision becomes mandatory. After removal of the cement and hardware, a cemented arthroplasty can be repeated if enough cancellous bone matrix exists to grip the new PMMA. Alternatively, cement-less prosthesis can be installed. Such a revision, however, can only be applied to total joint replacement failures. For vertebroplasty and/or kyphoplasty, a classical screw and plate internal fixation with autograft fusion is necessary.

[0011] Despite advances in the foregoing procedures, there remains a need for improved bone cement delivery systems which enable rapid and controllable deployment of bone cement for the treatment of conditions such as vertebral compression fractures.

SUMMARY OF THE INVENTION

[0012] There is provided in accordance with one aspect of the present invention, a steerable vertebroplasty device having a cavity , creation element. The vertebroplasty device comprises an elongate tubular body, having a proximal end, a distal end, and a central lumen extending therethrough. A deflectable zone is provided on the distal end of the tubular body, for deflection through an angular range. A handle is provided on the proximal end of the tubular body, having a deflection control thereon A cavity creating element may be carried by the deflectable zone. In one embodiment, the cavity creating element is an inflatable balloon, in communication with a proximal inflation port by way of an elongate inflation lumen extending throughout the length of the tubular body.

[0013] The deflection control may comprise a rotatable element, such as a knob rotatable about the longitudinal axis of the handle.

[0014] The distal end of the tubular body is provided with at least one exit port in communication with the central lumen. The exit port may open in a lateral direction, an axial direction, or along an inclined surface positioned distally of a transition point between the longitudinal side wall of the tubular body and the distal end of the distal tip.

[0015] Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred -3- WO 2009/065085 2017204475 30Jun2017 PCT/US2008/083698 embodiments which follows, when considered together with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a perspective view of a steerable injection needle in accordance with one aspect of the present invention.

[0017] Figure 2 is a perspective view of an introducer in accordance with one aspect of the present invention.

[0018] Figure 3 is a perspective view of a stylet in accordance with one aspect of the present invention.

[0019] Figure 4 is a side elevational view of the steerable injection needle moveably coaxially disposed within the introducer, in a substantially linear configuration.

[0020] Figure 5 is a side elevational view of the assembly of Figure 4, showing the steerable injection needle in a curved configuration.

[0021] Figure 6 is a side elevational schematic view of another steerable injection needle in accordance with the present invention.

[0022] Figure 7A is a schematic view of a distal portion of the steerable needle of Figure 6, shown in a linear configuration.

[0023] Figure 7B is a schematic view as in Figure 7A, following proximal retraction of a pull wire to laterally deflect the distal end.

[0024] Figure 8 is a schematic view of a distal portion of a steerable needle, having a side port.

[0025] Figure 9A is a schematic view of a distal portion of a steerable needle, positioned within an outer sheath.

[0026] Figure 9B is an illustration as in Figure 9A, with the distal sheath partially proximally retracted.

[0027] Figure 9C is an illustration as in Figure 9B, with the outer sheath proximally retracted a sufficient distance to fully expose the deflection zone.

[0028] Figures 1QA-1QC illustrate various aspects of an alternative deflectable needle in accordance with the present invention. PCT/US2008/083698 WO 2009/065085 2017204475 30Jun2017 [0029] Figures 11A through 11C illustrate various aspects of a further deflectable needle design in accordance with the present invention.

[0030] Figures 12 and 13 illustrate a further variation of the deflectable needle design in accordance with the present invention.

[0031] Figure 14 is a side elevational cross section through die proximal handle of the deflectable needle illustrated in Figure 13.

[0032] Figure 15 is a cross sectional detail view of the distal tip of the steerable needle illustrated in Figure 13.

[0033] Figures 15A through 15H illustrate various views of alternative distal tip designs. {0034] Figures 16A and 16B are schematic illustrations of the distal end of a steerable injection device in accordance with the present invention, having a cavity creating element thereon.

[0035] Figures 16C and 16D are alternative cross sectional views taken along the line 16C-16C in Figure 16A, showing different inflation lumen configurations.

[0036] Figures 17A and 17B illustrate an alternative steerable injection device having a cavity creation element thereon.

[0037] Figures 18A and 18B are schematic views of a bone cement delivery system in accordance with the present invention.

[0038] Figures 19A through 19F show stages in the method of accomplishing vertebroplasty in accordance with present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0039] The present invention provides improved delivery systems for delivery of a bone cement or bone cement composite for the treatment of vertebral compression fractures due to osteoporosis (OSP), osteo-trauma, and benign or malignant lesions such as metastatic cancers and myeloma, and associated access and deployment tools and procedures.

[0040] The primary materials in the preferred bone cement composite are methyl methacrylate and inorganic cancellous and/or cortical bone chips or particles. Suitable inorganic bone chips or particles are sold by Allosource, Osteotech and LifeNet (K053098); all have been cleared for marketing by FDA The preferred hone cement also may contain the -5- PCT/US2008/083698 WO 2009/065085 2017204475 30 Jun 2017 additives: barium sulfate for radio-opacity, benzoyl peroxide as an initiator, N,N-dimethyI-p-toluidine as a promoter and hydroquinone as a stabilizer. Other details of bone cements and systems are disclosed in U.S. Patent Application Serial No. 11/626,336, filed January 23, 2007, the disclosure of which is hereby incorporated in its entirely herein by reference.

[0041] One preferred bone cement implant procedure involves a two-step injection process with two different concentrations of the bone particle impregnated cement To facilitate the implant procedure the bone cement materials are packaged in separate cartridges containing specific bone cement and inorganic bone particle concentrations for each step. Tables 1 and 2, infra, list one example of the respective contents and concentrations in Cartridges 1A and IB for the first injection step, and Cartridges 2A and 2B for the second injection step.

[0042] The bone cement delivery system generally includes at least three main components: 1) stylet; 2) introducer cannula; and 3) steerable injection needle. See Figures 1-3. Packaged with the system or packaged separately is a cement dispensing pump. The complete system also preferably includes at least one cement cartridge having at least two chambers therein, and a spiral mixing nozzle.

[0043] The stylet is used to perforate a hole into the pedicle of the vertebra to gain access to the interior of the vertebral body.

[0044] The introducer cannula is used for bone access and as a guide for the steerable injection needle. The introducer cannula is sized to allow physicians to perform vertebroplasty or kyphoplasty on vertebrae with small pedicles such as the thoracic vertebra T5 as well as larger vertebrae. In addition, this system is designed for uni-transpedicular access and/or bi-pedicular access.

[0045] Once bone access has been achieved, the steerable injection needle can be inserted through the introducer cannula into the vertebra. The entire interior vertebral body may be accessed using the steerable injection needle. The distal end of the needle can be manually shaped to any desired radius within the product specifications. The radius is adjusted by means of a knob on the proximal end of the device.

[0046] The hand-held cement dispensing pump may be attached to the steerable injection needle by a slip-ring luer fitting. The pre-filled 2-chambered cartridges (1A and IB, -6- PCT/DS2008/083698 WO 2009/065085 2017204475 30 Jun 2017 and 2A and 2B) are loaded into die dispensing pump. As the handle of the dispensing pump is squeezed, each piston pushes the cartridge material into the spiral mixing tube. The materials are mixed in the spiral mixing nozzle prior to entering the steerable injection needle. The ratio of diameters of the cartridge chambers determines the mixing ratio for achieving the desired viscosity.

[0047] The bone cement implant procedures described herein use established vertebroplasty and kyphoplasty surgical procedures to stabilize the collapsed vertebra by injecting bone cement into cancellous bone.

[0048] The preferred procedure is designed for uni-transpedicular access and may be accomplished under either a local anesthetic or short-duration general anesthetic. Once the area of the spine is anesthetized, an incision is made and the stylet is used to perforate the vertebral pedicle and gain access to the interior of the vertebral body. The introducer cannula is then inserted and acts as a guide for the steerable injection needle.

[0049] Injection of the preferred bone cement involves a two-step procedure. The pre-filled Cartridges 1A and IB are loaded into the dispensing pump. As the dispensing pump handle is squeezed, each piston pushes material into the spiral mixing tube. The diameter of each chamber may be utilized to determine the mixing ratio for achieving the desired viscosity.

[0050] The first step involves injecting a small quantity of PMMA with more than about 35%, e.g., 60% inorganic bone particles, onto the outer periphery of the cancellous bone matrix, i.e., next to the inner wall of the cortical bone of the vertebral body. The cement composite is designed to harden relatively quickly, forming a firm but still pliable shell. This shell is intended to prevent bone marrow/PMMA content from being ejected through any venules or micro-fractures in the vertebral body wall. The second step of the procedure involves a second injection of PMMA with an approximately 30% inorganic bone particles to stabilize the remainder of the weakened, compressed cancellous bone.

[0051] Alternatively, the steerable needle disclosed herein and discussed in greater detail below, can he used in conventional vertebroplasty procedures, using a single step bone cement injection. -7- PCT/US2008/083698 WO 2009/065085 2017204475 30Jun2017 [0052] Injection control for the first and second steps is provided by a 2 mm ID flexible injection needle, which is coupled to the hand operated bone cement injection pump. The 60% (> 35%) and 30% ratio of inorganic bone particle to PMMA concentrations may be controlled by the pre-filled cartridge sets. 1A and IB, and 2A and 2B. At all times, the amount of the injectate is under the direct control of the surgeon or intervention radiologist and visualized by fluoroscopy. The introducer cannula is slowly withdrawn from the cancellous space as the second injection of bone cement begins to harden, thus preventing bone marrow/PMMA content from exiting the vertebral body. The procedure concludes with closure of the surgical incision with bone filler. In vitro and in vivo studies have shown that the 60% (> 35%) boue-particle impregnated bone cement hardens in 2-3 minutes and 30% bone-particle impregnated bone cement hardens between 4 to 10 minutes.

[0053] Details of the system components will be discussed below.

[0054] There is provided in accordance with the present invention a steerable injection device that can be used to introduce any of a variety of materials or devices for diagnostic or therapeutic purposes. In one embodiment, the system is used to inject bone cement, e.g., PMMA or any of the bone cement compositions disclosed elsewhere herein. The injection system most preferably includes a tubular body with a steerable (/. e., deflectable) distal portion for introducing bone cement into various locations displaced laterally from the longitudinal axis of the device within a vertebral body during a vertebroplasty procedure.

[0055] Referring to Figure 1, there is illustrated a side perspective view of a steerable injection needle 10 in accordance with one aspect of the present invention. The steerable injection needle 10 comprises an elongate tubular body 12 having a proximal end 14 and a distal end 16. The proximal end 14 is provided with a handle or manifold 18, adapted to remain outside of the patient and enable introduction and/or aspiration of bone cement or other media, and control of the distal end as will be described herein. In general, manifold 18 is provided with at least one injection port 20, which is in fluid communication with a central lumen (not illustrated) extending through tubular body 12 to at least one distal exit port 22. -8- PCT/US2008/083698 2017204475 30 Jun 2017 WO 2009/065085 {0056] The manifold 18 is additionally provided with a control 26 such as a rotatable knob, slider, or other moveable control, for controllably deflecting a deflection zone 24 on the distal end 16 of the tubular body 12. As is described elsewhere herein, the deflection zone 24 may be advanced from a relatively linear configuration as illustrated in Figure 1 to a deflected configuration throughout an angular range of motion.

[0057] Referring to Figure 2, there is illustrated an elongate tubular introducer 30, having a proximal end 32, a distal end 34 and an elongate tubular body 36 extending therebetween. A central lumen 3S (not shown) extends between a proximal access port 40 and a distal access port 42.

[0058] The central lumen 38 has an inside diameter which is adapted to slideably axially receive the steerable injection needle 10 therethrough. This enables placement of the distal end 34 adjacent a treatment site within the body, to establish an access pathway from outside of the body to the treatment site. As will be appreciated by those of skill in the art, the introducer 30 enables procedures deep within the body such as within the spine, through a minimally invasive and/or percutaneous access. The steerable injection needle 10 and/or other procedure tools may be introduced into port 40, through lumen 38 and out of port 42 to reach the treatment site.

[0059] The proximal end 32 of introducer 30 may be provided with a handle 44 for manipulation during the procedure. Handle 44 may be configured in any of a variety of ways, such as having a frame 46 with at least a first aperture 48 and a second aperture 50 to facilitate grasping by the clinician.

[0060] Referring to Figure 3, there is illustrated a perspective view of stylet 60. Stylet 60 comprises a proximal end 62, a distal end 64 and an elongate body 66 extending therebetween. The proximal end 62 may be provided with a stop 68 such as a grasping block, manifold or other structure, to facilitate manipulation by the clinician. In the illustrated embodiment, the block 68 is configured to nest within a recess 70 on the proximal end of the introducer 30.

[0061] As will be appreciated by those of skill in the art, the stylet 60 has an outside diameter which is adapted to coaxially slide within the central lumen on introducer 30. When block 68 is nested within recess 70, a distal end 64 of stylet 60 is exposed beyond -9- PCT/US2008/083698 WO 2009/065085 2017204475 30Jun2017 the distal end 34 of introducer 30. The distal end 64 of stylet 60 may be provided with a pointed tip 72, such as for anchoring into the surface of a bone.

[0062] Referring to Figure 4, there is illustrated a side elevational view of an assembly in accordance with the present invention in which a steerable injection needle 10 is coaxially positioned within an introducer 30. The introducer 30 is axially moveably carried on the steerable injection needle 10. In the illustration of Figure 4, the introducer 30 is illustrated in a distal position such that it covers at least a portion of the deflection zone 24 on injection needle 10.

[0063] Figure 5 illustrates an assembly as in Figure 4, in which the introducer 30 has been proximally retracted along flie injection needle 10 to fully expose the deflection zone 24 on injection needle 10. In addition, the control 26 has been manipulated to deflect the deflection zone 24 through an angle of approximately 90°. Additional details of the steerable needle will be discussed below.

[0064] Figure 6 illustrates a schematic perspective view of an alternate steerable vertebroplasty injector, according to one embodiment of the invention. The steerable injector 700 includes a body or shaft portion 702 that is preferably elongate and tubular, input port 704, adjustment control 706, and handle portion 708. The elongate shaft 702 preferably has a first proximal portion 710 and a second distal portion 712 which merge at a transition point 714. Shaft 702 may be made of stainless steel, such as 304 stainless steel, Nitinol, Elgiloy, or other appropriate material. Alternatively, the tubular body 702 may be extruded from any of a variety of polymers well known in the catheter arts, such as PEEK, PEBAX, nylon and various polyethylenes. Extruded tubular bodies 702 may be reinforced using metal or polymeric spiral wrapping or braided wall patterns, as is known in the art.

[0065] . The shaft 702 defines at least one lumen therethrough that is preferably configured to cany a flowable bone cement prior to hardening. Proximal portion 710 of shaft 702 is preferably relatively rigid, having sufficient column strength to push through cancellous bone. Distal portion 712 of shaft 702 is preferably flexible and/or deflectable and reversibly actuatable between a relatively straight configuration and one or more deflected configurations or curved configurations as illustrated, for example, in Figure S, as will be described in greater detail below. The distal portion 712 of shaft 702 may include a plurality -10- PCT/US2008/083698 WO 2009/065085 2017204475 30 Jun2017 of transverse slots 718 that extend partially circumferentially around the distal portion 712 of the shaft 702 to provide a plurality of flexion joints to facilitate bending.

[0066] input port 704 may be provided with a Luer lock connector although a wide variety of other connector configurations, e.g., hose barb or slip fit connectors can also be used. Lumen 705 of input port 704 is fluidly connected to central lumen 720 of shaft 702 such that material can flow from a source, through input port 704 into central lumen 720 of the shaft 702 and out the open distal end or out of a side opening on distal portion 712. Input port 704 is preferably at least about 20 gauge and may be at least about 18, 16, 14, or 12 gauge or larger in diameter.

[0067] Input port 704 advantageously allows for releasable connection of the steerable injection device 700 to a source of hardenable media, such as a bone cement mixing device described herein. In some embodiments, a plurality of input ports 704, such as 2, 3,4, or more ports are present, for example, for irrigation, aspiration, introduction of medication, hardenable media precursors, hardenable media components, catalysts or as a port for other tools, such as a light source, cautery, cutting tool, visualization devices, or the like. A first and second input port may be provided, for simultaneous introduction of first and second bone cement components such as from a dual chamber syringe or other dispenser. A mixing chamber may be provided within the injection device 700, such as within the proximal handle, or within the tubular shaft 702 [0068] A variety of adjustment controls 706 may be used with the steerable injection system, for actuating the curvature of the distal portion 712 of the shaft 702. Preferably, the adjustment control 706 advantageously allows for one-handed operation by a physician. In one embodiment, the adjustment control 706 is a rotatable member, such as a thumb wheel or dial. The dial can be operably connected to a proximal end of an axially movable actuator such as pull wire 724. See Figure 7A. When the dial is rotated in a first direction, a proximally directed tension force is exerted on the pull wire 724, actively changing the curvature of the distal portion 712 of the shaft 702 as desired. The degree of deflection can be observed fluoroscopically, and/or by printed or other indicium associated with the control 706. Alternative controls include rotatable knobs, slider switches, -11- PCT/US2008/083698 WO 2009/065085 2017204475 30 Jun 2017 compression grips, triggers such as on a gun grip handle, or other depending upon the desired functionality.

[0069] In some embodiments, the adjustment control 706 allows for continuous adjustment of the curvature of the distal portion 712 of shaft 702 throughout a working range. In other embodiments, the adjustment control is configured far discontinuous (i.e„ stepwise) adjustment, e.g., via a ratcheting mechanism, preset slots, deflecting stops, a rack and pinion system with stops, ratcheting band (adjustable zip-tie), adjustable cam, or a rotating dial of spring loaded stops. In still other embodiments^ the adjustment control 706 may include an automated mechanism, such as a motor or hydraulic system to facilitate adjustment.

[0070] The adjustment control may be configured to allow deflection of the distal portion 712 through a range of angular deviations from 0 degrees (i.e., linear) to at least about 15°, and often at least about 25°, 35°, 60°, 90°, 120°, 150°, or more degrees from linear.

[0071] In some embodiments, the length X of the flexible distal portion 712 of shaft 702 is at least about 10%, in some embodiments at least about 15%, 25%, 35%, 45%, or more of the length Y of the entire shaft 702 for optimal deliveiy of bone cement into a vertebral body. One of ordinary skill in the art will recognize that the ratio of lengths X:Y can vary depending on desired clinical application. In some embodiments, the maximum working length of needle 702 is no more than about 15”, 10”, 8”, 7”, 6”, or less depending upon the target and access pathway. In one embodiment, when the working length of needle 702 is no more than about 8”, the adjustable distal portion 712 of shaft has a length of at least about 1” and preferably at least about 1.5” or 2”.

[0072] Figures 7A-B are schematic perspective views of a distal portion of shaft 702 of a steerable vertebroplasty injector, according to one embodiment of the invention. Shown is the preferably rigid proximal portion 710 and deflectable distal portion 712. The distal portion 712 of shaft 702 includes a plurality of transverse slots 718 that extend partially circumferentially around the distal portion 712 of the shaft 702, leaving a relatively axially non-compressible spine 719 in die form of the unslotted portion of the tubular wall.

[0073] In some embodiments, the slots 718 can be machined or laser cut out of the tube stock that becomes shaft 702, and each slot may have a linear, chevron or other -12- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 shape. In other embodiments, the distal portion 712 of shaft 702 may be created from an elongate coil rather than a continuous tube.

[0074] Slots 718 provide small compression hinge joints to assist in die reversible deflection of distal portion 712 of shaft 702 between a relatively straightened configuration and one or more curved configurations. One of ordinary skill in the art will appreciate that adjusting the size, shape, and/or spacing of the slots 718 can impart various constraints on the radius of curvature and/or limits of deflection for a selected portion of the distal portion 712 of shaft 702. For example, the distal portion 712 of shaft 702 may be configured to assume a second, fully deflected shape with a relatively constant radius of curvature throughout its length. In other embodiments, the distal portion 712 may assume a progressive curve shape with a variable radius of curvature which may, for example, have a decreasing radius distally. In some embodiments, the distal portion may be laterally displaced through an arc having a radius of at least about 0.5”, 0.75”, 1.0”, 1.25”, or 1.5” minimum radius (fully deflected) to a> (straight) to optimize delivery of bone cement within a vertebral body. Wall patterns and deflection systems for bendable slotted tubes are disclosed, for example, in U.S. Patent Publication No. 2005/0060030 A1 to Lashinski et al., the disclosure of which is incorporated in its entirety by reference herein.

[0075] Still referring to Figures 7A-B, a pull wire 724 resides within the lumen 720 of shaft 702. The distal end 722 of the pull wire 724 is preferably operably attached, such as by adhesive, welding, soldering, crimping or the like, to an inner side wall of the distal portion 712 of the shaft 702. Preferably, the attachment point will be approximately 180° offset from the center of the axially extending spine 719. Proximal portion of pull wire 724 is preferably operably attached to adjustment control 706. The adjustment control 706 may be configured to provide an axial pulling force in the proximal direction toward the proximal end of pull wire 724. This in turn exerts a proximal traction on the distal portion 712 of shaft 702 operably attached to distal end 722 of pull wire 724. The slotted side of the tubular body shortens under compression, while the spine side 719 retains its axial length causing the distal portion 712 of shaft 702 to assume a relatively curved or deflected configuration. In some embodiments, a plurality of pull wires, such as two, three, four, or more pull wires 724 may be present within the lumen 720 with distal points of attachment spaced axially apart to -13- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 allow the distal portion 712 of shaft 702 to move through compound bending curves . depending on the desired bending characteristic. Distal axial advance of the actuator will cause a deflection in an opposite direction, by increasing the width of die slots 718.

[0076J A distal opening 728 is provided on shaft 702 in communication with central lumen 720 to permit expression of material, such as bone cement, from the injector 700. Some embodiments may include a filter such as mesh 812. Mesh structure 812 can advantageously control cement output by controlling bubbles and/or preventing undesired large or unwieldy aggregations of bone cement from being released at one location and thus promote a more even distribution of bone cement within the vertebral body. The mesh 812 may be created by a laser-cut cris-crossing pattern within distal end as shown, or can alternatively be separately formed and adhered, welded, or soldered on to the distal opening 728. Referring to Figure 8, the distal shaft portion 712 may also include an end cap 730 or other structure for occluding central lumen 720, and a distal opening 728 on the sidewall of shaft 702.

[0077] In some embodiments, the distal shaft 712 can generate a lateral force of at least about 0.125 pounds, 0.25 pounds, 0.5 pounds, 1 pound, 1.5 pounds, 2 pounds, 3 pounds, 4 pounds, 5 pounds, 6 pounds, 7 pounds, 8 pounds, 9 pounds, 10 pounds, or more by activating control 706. This can be advantageous to ensure that the distal portion 712 is sufficiently navigable laterally through cancellous bone to distribute cement to the desired locations. In some embodiments, the distal shaft 712 can generate a lateral force of at least about 0.125 pounds but no more than about 10 pounds; at least about 0.25 pounds but no more than about 7 pounds; or at least about 0.5 pounds but no more than about 5 pounds.

[0078] In some embodiments, the distal portion 712 of shaft 702 (or end cap 730) has visible indicia, such as, for example, a marker visible via one or more imaging techniques such as fluoroscopy, ultrasound, CT, or MRI.

[0079] Figures 9A-C illustrate in schematic cross-section another embodiment of a distal portion 734 of a steerable injection device 740. The tubular shaft 736 can include a distal portion 734 made of or containing, for example, a shape memory material that is biased into an arc when in an unconstrained configuration. Some materials that can be used for the distal curved portion 734 include Nitinol, Elgiloy, stainless steel, or a shape memory -14- PCT/US2008/083698 2017204475 30 Jun 2017 WO 2009/065085 polymer. A proximal portion 732 of the shaft 736 is preferably relatively straight as shown. Also shown is end cap 730, distal lateral opening 728 and mesh 812.

[0080] The distal curved portion 734 may be configured to be axially movably received within an outer tubular sheath 738. The sheath 738 is preferably configured to have sufficient rigidity and radial strength to maintain the curved distal portion 734 of shaft 732 in a relatively straightened configuration while the outer tubular sheath 738 coaxially covers the curved distal portion 734. Sheath 738 can be made of, for example, a metal such as stainless steel or various polymers known in the catheter arts. Axial proximal withdrawal of the sheath 738 with respect to tubular shaft 736 will expose an unconstrained portion of the shape memory distal end 734 which will revert to its unstressed arcuate configuration. Retraction of the sheath 738 may be accomplished by manual retraction by an operator at the proximal end, retraction of a pull wire attached to a distal portion of the sheath 738, or other ways as known in the art. The straightening function of the outer sheath 738 may alternatively be accomplished using an internal stiffening wire, which is axially movably positionable within a lumen extending through the tubular shaft 736. The length, specific curvature, and other details of the distal end may be as described elsewhere herein [0081] In another embodiment, as shown in Figures 10A-C, tubular shaft 802 of a steerable vertebroplasty injector may be generally substantially straight throughout its length in its unstressed state, or have a laterally biased distal end. A distally facing or side facing opening 810 is provided for the release of a material, such as bone cement. In this embodiment, introducer 800 includes an elongate tubular body 801 with a lumen 805 therethrough configured to receive the tubular shaft (also referred to as a needle) 802. Introducer 800 can be made of any appropriate material, such as, stainless steel and others disclosed elsewhere herein. Needle 802 may be made of a shape memory material, such as nitinol, with superelastic properties, and has an outside diameter within the range of between about 1 to about 3mm, about 1.5-2.5mm, or about 2.1mm in some embodiments.

[0082] Introducer 800 includes a needle-redirecting element 804 such as an inclined surface near its distal end. Needle-redirecting element 804 can be, for example, a laser-cut tang or a plug having a proximal surface configured such that when needle 802 is advanced distally into introducer 800 and comes in contact with the needle-redirecting -15- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 element 804, a distal portion 814 of needle 802 is redirected out an exit port 806 of introducer 800 at an angle 808, while proximal portion 816 of needle 802 remains in a relatively straightened configuration, as shown in Figure 10B. Bone cement can then be ejected from distal opening 810 on the end or side of needle 802 within bone 1000. Distal opening 810 may be present at the distal tip of the needle 802 (coaxial with the long axis of the needle 802) or alternatively located on a distal radial wall of needle 802 as shorn in Figure 10C. In some embodiments, the angle 808 is at least about 15 degrees and may be at least about 30,45, 60, 90,105 degrees or more with respect to the long axis of the introducer 800.

[0083] The illustrated embodiment of Figures 10A-C and other embodiments disclosed herein are steerable through multiple degrees of freedom to distribute bone cement to any area within a vertebral body. For example, the introducer 800 and needle 802 can both rotate about their longitudinal axes with respect to each other, and needle 802 can move coaxially with respect to the introducer 800, allowing an operator to actuate the injection system three dimensionally. The distal portion 814 of needle 802 can be deflected to a position that is angularly displaced from the long axis of proximal portion 816 of needle without requiring a discrete curved distal needle portion as shown in other embodiments herein, [0084] Figures 11A-C illustrate another embodiment of a steerable vertebroplasty injector. Figure 11A schematically shows handle portion 708, adjustment control 706, and elongate needle shaft 702, including proximal portion 710, distal portion 712, and transition point 714. Figure 1 IB is a vertical cross-section through line A-A of Figure 11A, and shows adjustment control 706 operably connected to pull wire 724 such as through a threaded engagement. Also shown is input port 704, and proximal portion 710 and distal portion 712 of needle shaft 702. Figure 11C illustrates a cross-sectional view of distal portion 712 of shaft 702. The distal end 722 of pull wire 724 is attached at an attachment point 723 to the distal portion 712 of shaft 702. Proximal retraction on pullwire 724 will collapse transverse slots 718 and deflect the injector as has been discussed. Also shown is an inner tubular sleeve 709, which can be advantageous to facilitate negotiation of objects or media such as bone cement, through the central lumen of the needle shaft 702. -16- PCT/US2008/083698 WO 2009/065085 2017204475 30Jun2017 [0085] The interior sleeve 709 is preferably in the form of a continuous, tubular flexible material, such as nylon or polyethylene. In an embodiment in which the needle 702 has an outside diameter of 0,095 inches (0.093 inch coil with a 0.001 inch thick outer sleeve) and an inside diameter of0.077 inches, the interior tubular sleeve 709 may have an exterior diameter in the area of about 0.074 inches and an interior diameter in the area of about 0.069 inches. The use of this thin walled tube 705 on the inside of the needle shaft 702 is particularly useful for guiding a fiber through the needle shaft 702. The interior tube 705 described above is additionally preferably fluid-tight, and can be used to either protect the implements transmitted therethrough from moisture, or can be used to transmit bone cement through die steerable needle.

[0086] In some embodiments, an outer tubular coating or sleeve (not shown) is provided for surrounding the steerable needle shaft at least partially throughout die distal end of the needle. The outer tubular sleeve may be provided in accordance with techniques known in the art and, in one embodiment, is a thin wall polyester (e.g., ABS) heat shrink tubing such as that available from Advanced Polymers, Inc. in Salem, N.H. Such heat shrink tubings have a wall thickness of as little as about 0,0002 inches and tube diameter as little as about 0.010 inches. The outer tubular sleeve enhances the structural integrity of the needle, and also provides a fluid seal and improved lubricity at the distal end over embodiments with distal joints 718. Furthermore the outer tubular sleeve tends to prevent the device from collapsing under a proximal force on a pull wire. The sleeve also improves pushability of the tubular members, and improves torque transmission.

[0087] In other embodiments, instead of a slotted tube, the needle shaft of a vertebroplasty injection system may include a metal or polymeric coil. Steerable helical coil-type devices are described, for example, in U.S. Patent Nos. 5,378,234 or 5,480,382 to Hammerslag et al., which are both incorporated by reference herein in their entirety.

[0088] An interior tubular sleeve (not illustrated) may be provided to facilitate flow of media through the central lumen as described elsewhere in the application. In some embodiments, a heat-shrink outer tubular sleeve as described elsewhere in the application is also provided to enhance the structural integrity of the sheath, provide a fluid seal across the chevrons or slots, as well as improve lubricity. -17- WO 2009/065085 PCT/US2008/083698 2017204475 30Jun2017 [0089] The steerable injection needle (also referred to as the injection shaft) may have an outside diameter of between about 8 to 24 gauge, more preferably between about 10 to 18 gauge, e.g., 12 gauge, 13 gauge (0.095” or 2.41 mm), 14 gauge, 15 gauge, or 16 gauge. In some embodiments, the inside diameter (luminal diameter) of the injection needle is between about 9 to 26 gauge, more preferably between about 11 to 19 gauge, e.g., 13 gauge, 14 gauge, 15 gauge, 16 gauge, or 17 gauge. In some embodiments, the inside diameter of the injection needle is no more than about 4 gauge, 3 gauge, 2 gauge, or 1 gauge smaller than Ihe outside diameter of the injection needle.

[0090] The inside luminal diameter of all of the embodiments disclosed herein is preferably optimized to allow a minimal exterior delivery profile while maximizing the amount of bone cement that can be carried by the needle. In one embodiment, the outside diameter of the injection needle is 13 gauge (0.095” or 2.41 mm) with a 0.077” (1.96 mm) lumen. In some embodiments, the percentage of the inside diameter with respect to the outside diameter of the injection needle is at least about 60%, 65%, 70%, 75%, 80%, 85%, or more.

[0091] Referring to Figures 12 and 13, there is illustrated a modification of the steerable injection needle 10, in accordance with the present invention. The injection needle 10 comprises an elongate tubular shaft 702, extending between a proximal portion 710 and a distal portion 712. The proximal portion 710 is carried by a proximal handle 708, which includes a deflection control 706 such as a rotatable knob or wheel. Rotation of the control 706 causes a lateral deflection or curvature of the distal steering region 24 as has been discussed.

[0092] Input port 704 is in fluid communication with a distal opening 728 on a distal tip 730, by way of an elongate central lumen 720. Input port 704 may be provided with any of a variety of releasable connectors, such as a luer or other threaded or mechanically interlocking connector known in the art. Bone cement or other media advanced through lumen 720 under pressure may be prevented from escaping through the plurality of slots 718 in the steering region 24 by the provision of a thin flexible tubular membrane carried either by the outside of tubular shaft 702, or on the interior surface defining central lumen 720. -18- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 [0093] Referring to Figure 14, the handle 708 is provided with an axially oriented central bore 732 having a first, female thread 733 thereon. A slider 734 having a second complementary male thread 735, is threadably engaged with the central bore 732. Rotation of the knob 706 relatively to the slider 734 thus causes the slider 734 to distally advance or proximally retract in an axial direction with respect to the handle 708. The slider 734 is mechanically linked to the pull wire 724, such as by the use of one or more set screws or other fastener 740.

[0094] Slider 734 is provided with at least one axially extending keyway or spline 742 for slideably engaging a slide dowel pin 744 linked to the handle 708. This allows rotation of the rotatable control 706, yet prevents rotation of the slider 734 while permitting axial reciprocal movement of the slider 734 as will be apparent to those of skill in the art One or more actuating knob dowel pins 746 permits rotation of the rotatable control 706 with respect to the handle 708 but prevents axial movement of the rotatable control 706 with respect to the handle 708.

[0095] Referring to Figure 15, the distal end of die shaft 702 may be provided with any of a variety of distal opening 728 orientations or distal tip 730 designs, depending upon the desired functionality. In the illustrated embodiment, the distal tip 730 is provided with an annular flange 748 which may be slip fit into the distal end of the tubular body 702, to facilitate attachment. The attachment of the distal tip 730 may be further secured by welding, crimping, adhesives, or other bonding technique.

[0096] In general, the distal tip 730 includes a proximal opening 750 for receiving media from the central lumen 720, and advancing media through distal opening 728. Distal opening 728 may be provided on a distally facing surface, on a laterally facing surface, or on an inclined surface of the distal tip 730.

[0097] Referring to Figures 15A and 15B, there is illustrated a distal tip 30 having a single inclined opening 728 thereon. In any of the designs disclosed herein, one or two or three or four or more distal ports 728 may be provided, depending upon the desired clinical performance. In the illustrated embodiment, the distal tip includes a rounded distal end 750 which transitions either smoothly or through an angular interface with an inclined portion 752. The distal opening 728 is positioned distally of a transition 754 at the proximal limit of -19- PCT/US2008/083698 2017204475 30Jun2017 WO 2009/065085 the inclined surface 752. This configuration enables the distal opening 728 to have a distal axially facing component, as compared to an embodiment having a side wall opening. See, for example, Figure 8.

[0098] Referring to Figure 15B, the tip 730 can be considered to have a central longitudinal axis 770. The aperture 728 may be considered as residing on an aperture plane 772, which intersects the distal most limit and die proximal most limit of the aperture 728. Aperture plane 772 intersects the longitudinal axis at an angle 6. In an embodiment having a side wall aperture, the aperture plane 772 and longitudinal axis 770 would be parallel. In an embodiment having a completely distally feeing aperture, the aperture plane 772 would intersect the longitudinal axis 770 at an angle of 90°.

[0099] In the illustrated embodiment, the inclined aperture 728 is defined by an aperture plane 772 intersecting the longitudinal axis 770 at an angle Θ which is at least about 5°, often at least about 15°, and in many embodiments, at least about 25° or more. Intersection angles within the range of from about 15° to about 45° may often be used, depending upon the desired clinical performance.

[0100] Referring to Figures 15C and 15D, an alternate distal tip 730 is illustrated. In this configuration, the distal opening 728 is in the form of a sculpted recess 756 extending axially in alignment with at least a portion of the central lumen 720. Sculpted recess 756 may be formed in any of a variety of ways, such as by molding, or by drilling an axial bore in an axial direction with respect to the tip 730. The sculpted recess 756 cooperates with the tubular body 702, as mounted, to provide a distal opening 728 having an inclined aspect as well as an axially distally facing aspect with respect to the longitudinal axis of the steerable needle.

[0101] Referring to Figures 15E and 15F, there is illustrated a distal tip 730 having a plurality of distally facing apertures 728. In the illustrated embodiment, four distal apertures are provided. The distal apertures 728 may be provided on the rounded distal end 750, or on an inclined surface 752 as has been discussed.

[0102] Referring to Figures 15G and 15H, there is illustrated an alternative distal tip 730. In this configuration, an opening 728 is oriented in a distally facing direction with respect to the longitudinal axis of the needle. The distal opening of the central lumen is -20- PCT/US2008/083698 2017204475 30Jun2017 WO 2009/065085 covered by at least one, preferably two, and, as illustrated, four leaflets 758 to provide a collet like configuration. Each of the adjacent leaflets 758 is separated by a slot 760 and is provided with a living hinge or other flexible zone 762.

[0103] In use, the distal tip 730 may be distally advanced through soft tissue, cortical or cancellous bone, with the distal opening 728 being maintained in a closed orientation. Following appropriate positioning of the distal tip 30, the introduction of bone cement or other media under pressure through the central lumen 720 forces the distal opening 728 open by radially outwardly inclining each leaflet 758 about its flection point 762. This configuration enables introduction of the needle without “coring” or occluding with bone or other tissue, while still permitting injection of bone cement or other media in a distal direction.

[0104] Any of the forgoing or other tip configurations may be separately formed and secured to the distal end of the tubular body 702, or may be machined, molded or otherwise formed integrally with the tube 702.

[0105] Alternatively, a distal opening aperture may be occluded by a blunt plug or cap, which prevents coring during distal advance of the device. Once positioned as desired, the distal cap may be pushed off of the distal end of the injector such as under the pressure of injected bone cement. The deployable cap may take any of a variety of forms depending upon the injector design. For example, it may be configured as illustrated in Figure 15A, only without the aperture 728. The flange 748 is slip fit within the distal end of the injector body, and retained only by friction, or by a mild bond which is sufficient to retain the cap 730 during manipulation of the injector, but insufficient to resist the force of injected bone cement. The deployable cap 730 may be made from any of a variety of materials, such as stainless steel, Nitinol, or other implantable metals; any of a wide variety of implantable polymers such as PEEK, nylon, PTFE; or of bone cement such as PMMA. Alternatively, any of a variety of bioabsorbable polymers may be utilized to form the deployable cap 730, including blends and polymers in the PLA-PGLA absorbable polymer families.

[0106] As a further alternative, coring during insertion of an injector having a distal opening may be prevented by positioning a removable obturator in the distal opening. The obturator comprises an elongate body, extending from a proximal end throughout the “21- PC17US2008/083698 2017204475 30Jun2017 WO 2009/065085 length of the injector to a blunt distal tip. The obturator is advanced axially in a distal direction through the central lumen, until the distal tip of the obturator extends slightly distally of the distal opening in the injector. This provides a blunt atraumatic tip for distal advance of the injector through tissue. Following positioning of the injector, the obturator may be proximally withdrawn from the. central lumen, and discarded. The obturator may be provided with any of a variety of structures for securing the obturator within the central lumen during the insertion step, such as a proximal cap for threadably engaging a complementary luer connector on the proximal opening of the central lumen.

[0107] In accordance with another aspect of the present invention, there is provided a combination device in which a steerable injector is additionally provided with a cavity formation element. Thus, the single device may be advanced into a treatment site within a bone, expanded to form a cavity, and used to infuse bone cement or other media into the cavity. Either or both of the expansion step and the infusion step may be accomplished following or with deflection of the distal portion of the injector.

[0108] Referring to Figures 16A and 16B, the distal portion 302 of a steerable injector 300 having a cavity formation element 320 thereon is schematically illustrated. The steerable injector 300 includes a relatively rigid proximal section 304 and a deflectable section 306 as has been discussed elsewhere herein. The lateral flexibility of distal section 306 may be accomplished in any of a variety of ways, such as by the provision of a plurality of transverse chevrons or slots 308. Slots 308 may be machined or laser cut into appropriate tube stock, such as stainless steel or any of a variety of rigid polymers.

[0109] The slots 308 oppose a column strength element such as an axially extending spine 310, for resisting axial elongation or compression of the device. A pull wire 312 axially moveably extends throughout the length of the tubular body, and is secured with respect to the tubular body distally of the transverse slots 308. The proximal end of the pull wire is operatively connected to a control on a proximal handpiece or manifold. The control may be any of a variety of structures, such as a lever, trigger, slider switch or rotatable thumb wheel or control knob. Axial proximal traction (or distal advance) of the pull wire 312 with respect to the tubular body causes a lateral deflection of the distal steering section 306, by axial compression or expansion of the transverse slots 308 relative to the spine 310. -22- PCT/DS2008/083698 2017204475 30 Jun2017 WO 2009/065085 [0110} A distal aperture 314 is in communication via a central lumen 316 with the proximal end of the steerable injector 300. Any of a variety of tip configurations may be used such as those disclosed elsewhere herein. The proximal end of the central lumen 316 may be provided with a luer connector, or other connection port to enable connection to a source of media such as bone cement to be infused. In the illustrated embodiment, the aperture 314 faces distally from the steerable injector 302, although other exit angles may be used as will be discussed below.

[0111] The steerable injector 300 is optionally provided with a cavity forming element 320, such as an inflatable balloon 322. In the illustrated embodiment, the inflatable balloon 322 is positioned in die vicinity of the steerable distal section 306. Preferably, the axial length of a distal leading segment 307 is minimized, so that 1he balloon 322 is relatively close to the distal end of the steerable injector 300. In this embodiment, the plurality of transverse slots 308 are preferably occluded, to prevent inflation media from escaping into the central lumen 316 or bone cement or other injectable media from escaping into the balloon 322. Occlusion of the transverse slots 308 may be accomplished in any of variety of ways, such as by positioning a thin tubular membrane coaxially about tire exterior surface of the tubular body and heat shrinking or otherwise securing the membrane across the openings. Any of a variety of heat shrinkable polymeric sleeves, comprising high density polyethylene or other materials, are well known in the catheter arts. Alternatively, a tubular liner may be provided within the central lumen 316, to isolate the central lumen from the transverse slots 308.

[0112] The balloon 322 is secured at a distal neck 309 to the leading segment 307 as is understood in the balloon catheter arts. The distal neck 309 may extend distally from the balloon, as illustrated, or may invert and extend proximally along the tubular body. In either event, the distal neck 309 of the balloon 322 is preferably provided with an annular seal 324 either directly to the tubular body 301 or to a polymeric liner positioned concentrically about the tubular body, depending upon the particular device design. This will provide an isolated chamber within balloon 322, which is in fluid communication with a proximal source of inflation media by way of an inflation lumen 326. -23- PCT/US2008/083698 2017204475 30Jun2017 WO 2009/065085 [0113J In the illustrated embodiment, the balloon 322 is provided with an elongate tubular proximal neck which extends throughout the length of the steerable injector 300, to a proximal port or other site for connection to a source of inflation media. This part can be blow molded within a capture tube as is well understood in the balloon catheter arts, to produce a one piece configuration. Alternatively, the balloon can be separately formed and bonded to a tubular sleeve. During assembly, the proximal neck or outer sleeve 328 may conveniently be proximally slipped over the tubular body 301, aud secured thereto, as will be appreciated by those of skill in the catheter manufacturing arts.

[0114] Referring to Figure 16C, the inflation lumen 326 may occupy an annular space between the outer sleeve 328 and the tubular body 301. This may be accomplished by sizing the inside dimension of the outer sleeve 328 slightly larger than the outside dimension of the tubular body 301, by an amount sufficient to enable the desired inflation flow rate as wiil be understood in the art. Alternatively, referring to Figure 16D, a discrete inflation lumen 326 may be provided while the remainder of the outer sleeve 328 is bonded or snuggly fit against the tubular body 301. This may be accomplished by positioning an elongate mandrel (not illustrated) between the outer sleeve 328 and the tubular body 301, and heat shrinking or otherwise reducing the outer sleeve 328, thereafter removing the mandrel to leave the discrete inflation lumen 326 in place. Alternatively, any of a variety of internal inflation lumen may be devised, within the central lumen 316 of tubular body 301.

[0115] Referring to Figures 17A and 17B, there is illustrated an alternative embodiment in which the distal aperture 314 is provided on a side wall of the tubular body. One or two or three or more distal apertures 314 may be provided in any of the embodiments disclosed herein, depending upon the desired clinical performance. In the illustrated embodiment, the distal aperture 314 is provided on the inside radius of curvature of the steerable section 306, as illustrated in Figure 17B. The aperture 314 may alternatively be provided on the opposite, outside radius of curvature, depending upon the desired clinical performance.

[0116] As a further alternative, the distal aperture or apertures 314 may be provided in any of a variety of configurations on a distal cap or tip, adapted to be secured to the tubular body. -24- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 [0117] The steerable injection systems described above are preferably used in conjunction with a mixing and dispensing pump for use with a multi-component cement. In some embodiments, a cement dispensing pump is a hand-held device having an interface such as a tray or chamber for receiving one or more cartridges, hr one embodiment, the pump is configured to removably receive a double-barreled cartridge for simultaneously dispensing first and second bone cement components. The system additionally includes a mixing chamber, for mixing the components sufficiently and reproducibly to fully automate the mixing and dispensing process within a closed system.

[0118] Bone cement components have conventionally been mixed, such as by hand, e.g., in mixing bowls in the operating room, which can be a time-consuming and unelegant process. The devices disclosed herein may be used with conventional bone cement formulations, such as manually mixed liquid-powder PMMA formulations. Alternatively, the use of a closed mixing device such as a double-barreled dispensing pump as disclosed herein is highly advantageous in reducing bone cement preparation time, preventing escape of fumes or ingredients, ensuring that premature cement curing does not occur (i.e., the components are mixed immediately prior to delivery into the body), and ensuring adequate mixing of components.

[0119] Two separate chambers contain respective materials to be mixed in a specific ratio. Manual dispensing (e.g., rotating a knob or squeezing a handle) forces both materials into a mixing nozzle, which may be a spiral mixing chamber within or in communication with a nozzle. In the spiral mixing nozzle, all or substantially all mixing preferably occurs prior to the bone cement entering the steerable injection needle and, subsequently, into the vertebra. The cement dispensing hand pump may be attached to the steerable injection needle permanently, or removably via a connector, such as slip-ring Luer fittings. A wide range of dispensing pumps can be modified for use with the present invention, including dispensing pumps described in, for example, U.S. Patent Nos. 5,184,757, 5,535,922, 6,484,904, and Patent Publication No. 2007/0114248, all of which are incorporated by reference in their entirety.

[0120] Currently favored bone cement compositions are normally stored as two separate components or precursors, for mixing at the clinical site shortly prior to -25- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 implantation. As has been described above, mixing of the bone cement components has traditionally been accomplished manually, such as by expressing the components into a mixing bowl in or near the operating room. In accordance with the present invention, the bone cement components may be transmitted from their storage and/or shipping containers, into a mixing chamber, and into the patient, all within a closed system. For this propose, the system of the present invention includes at least one mixing chamber positioned in the flow path between the bone cement component container and the distal opening on the bone cement injection needle. This permits uniform and automated or semi-automated mixing of the bone cement precursors, within a closed system, and thus not exposing any of the components or the mixing process at the clinical site.

[0121] Thus, the mixing chamber may be formed as a part of the cartridge, may be positioned downstream from the cartridge, such as in-between the cartridge and the proximal manifold on the injection needle, or within the proximal manifold on the injection needle or the injection needle itself, depending upon the desired performance of the device. The mixing chamber may be a discrete component which may be removably or permanently coupled in series flow communication with the other components of the invention, or may be integrally formed within any of the foregoing components.

[0122] In general, the mixing chamber includes an influent flow path for accommodating at least two bone cement components. The first and second incoming flow path are combined, and mixing structures for facilitating mixing of the components are provided. This may include any of a variety of structures, such as a helical flow path, baffles and or additional turbulence inducing structures.

[0123] Tables 1-2 below depict the contents and concentrations of one exemplary embodiment of bone cement precursors. Chambers 1A and IB contain precursors for a first cement composition for distribution around the periphery of the formed in place vertebral body implant with a higher particle concentration to promote osteoinduction, as discussed previously in the application. Chambers 2A and 2B contain precursors for a second cement composition for expression more centrally within the implanted mass within the vertebral body, for stability and crack arresting, as discussed previously in the application. -26- PCT/US2008/083698 WO 2009/065085 2017204475 30Jun2017 [0125] One of ordinary skill in the art will recognize that a wide variety of .chamber or cartridge configurations, and bone cements, can be used with the present injection system. For example, in one embodiment, a first cartridge includes pre-polymerized PMMA and a polymerization catalyst, while a. second cartridge includes a liquid monomer ofMMA as is common with some conventional bone cement formulations.

[0126] In some embodiments, the contents of two cartridges can be combined into a single cartridge having multiple (e.g., four) chambers. Chambers may be separated by a frangible membrane (e.g., 1A and 2A in a first cartridge and 15 and 2B in a second cartridge, each component separated by the frangible membrane or other pierceable or removable barrier). In other embodiments, contents of the below cartridges can be manually pre-mixed and loaded into the input port of the injection system without the use of a cement mixing dispenser.

Table 1.

Cham ber 1A Methyl methacrylate (balance) Hydroquinone (-75 ppm)(stabilizer) Ν,Ν-dimethyl-p-toluidine (~0.9%)(catalyst for polymerization) Sterile bone particles <>35 wt. %) Barium sulfate (-20 wt. %)(radio-opacifier) Cham ber IB Benzoyl peroxide (~2%)(activator for polymerization) Physiological saline or poppy seed oil (balance)

Table 2.

Cham >er2A Methyl methacrylate (balance) Hydroquinone (-75 ppm)(stabilizer) Ν,Ν-dimethyl-p-toluidine (~0.9%)(catalyst for polymerization) Sterile bone particles (-30 wt. %) Barium sulfate (~20 wt. %)(radio-opacifier) Cham )er2B Benzoyl peroxide (-2%)(activator for polymerization) Physiological saline or poppy seed oil (balance) -27- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 [0127] As illustrated in Figures 18A and 1 SB, in one embodiment, a system or kit for implanting bone cement includes at least some of the following components: a stylet configured to perforate a hole into the pedicle of the vertebral body; an introducer cannula 800 for providing an access pathway to the treatment site, a steerable injection needle 700 to deliver bone cement to a desired location, and, a cement dispensing pump 910 preferably configured to accommodate one or two or more dual chamber cartridges 1200 as well as a mixing nozzle 995.

[0128] The stylet may have a diameter of between about .030" to .300”, .050” to about .200” and preferably about ,100” in some embodiments. The introducer cannula 800 is between about 8-14 gauge, preferably between about 10-12 gauge, more preferably 11 gauge in some embodiments. The introducer cannula 800, which may be made of any appropriate material, such as stainless steel (e.g., 304 stainless steel) may have a maximum working length of no more than about 12”, 8", or 6” in some embodiments. One or two or more bone cement cartridges, each having one or two or more chambers, may also be provided. Various other details of the components have been described above in the application.

[0129] One embodiment of a method for delivering bone cement into a vertebral body is now described, and illustrated in Figures 19A-F. The method involves the general concept of vertebroplasty and kyphoplasty in which a collapsed or weakened vertebra is stabilized by injecting bone cement into cancellous bone.

[0130] The cement implantation procedure is designed for uni-transpedicular access and generally requires either a local anesthetic or short-duration general anesthetic for minimally invasive surgery. Once the area of the spine is anesthetized, as shown in Figures. 19A-B, the physician inserts a stylet 1302 to perforate a lumen 1304 into the pedicle wall 1300 of the vertebra 1308 to gain access to the interior of the vertebral body 1310. As illustrated in Figure 19C, the introducer cannula 800 is then inserted through the lumen 1304 for bone access as well as acting as the guide for the steerable injection needle 700. The introducer cannula 800 is sized to allow physicians to perform vertebroplasty or kyphoplasty on vertebrae with small pedicles 1300 such as the thoracic vertebra (e.g., T5) as well as larger vertebrae. In addition, this system and method is advantageously designed to allow uni- -28- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 transpedicular access as opposed to bi-pedicular access, resulting in a less invasive surgical procedure.

[0131] Once bone access has been achieved, as shown in Figure 19C the steerable injection needle 700 such as any of the devices described above can be inserted through the introducer cannula 800 and into the vertebra 1308. The entire interior 1310 of the target vertebral body may be accessed using the steerable injection needle 800. The distal end 712 of the needle 700 can be laterally deflected, rotated, and/or proximally retracted or distally advanced to position the bone cement effluent port at any desired site as previously described in the application. The radius can be adjusted by means of an adjustment control, such as a knob on the proximal end of the device as previously described.

[0132] The actual injection procedure may utilize either one or two basic steps. In a one step procedure, a homogenous bone cement is introduced as is done in conventional vertebroplasty. The first step in the two step injection involves injection of a small quantity of PMMA with more than about 35%, e.g., 60% particles such as inorganic bone particles onto the periphery of the treatment site, i.e., next to the cortical bone of the vertebral body as shown in Figure 19D. This first cement composite 1312 begins to harden rather quickly, forming a firm but still pliable shell, which is intended to minimize or prevent any bone marrow/PMMA content from being ejected tiuough any venules or micro-fractures in the vertebral body wall. The second step in the procedure involves an injection of a bolus of a second formulation of PMMA with a smaller concentration such as approximately 30% inorganic bone particles (second cement composite 1314) to stabilize the remainder of the weakened, compressed cancellous bone, as illustrated in Figure 19E.

[0133] Injection control for the first and second steps is provided by an approximately 2 mm inside diameter flexible introducer cannula 800 coupled to a bone cement injection pump (not shown) that is preferably hand-operated. Two separate cartridges containing respective bone cement and inorganic bone particle concentrations that are mixed in the 60% and 30% ratios are utilized to control inorganic bone particle to PMMA concentrations. The amount of the injectate is under the direct control of the surgeon or interventional radiologist by fluoroscopic observation. The introducer cannula 800 is slowly withdrawn from the cancellous space as the bolus begins to harden, thus preventing bone -29- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 marrow/PMMA content from exiting the vertebral body 1308. The procedure concludes with the surgical incision being closed, for example, with bone void filler 1306 as shown in Figure 19F. Both the high and low bone cement particle concentration cement composites 1312, 1314 harden after several minutes. In vitro and in vivo studies have shown that the . 60% bone-particle impregnated bone cement hardens in 2-3 minutes and 30% bone-particle impregnated bone cement hardens between 4 to 10 minutes.

[0134] The foregoing method can alternatively be accomplished utilizing the combination steerable needle of Figure 16A, having a cavity formation structure 320 thereon. Once the steerable injector 300 has been positioned as desired, such as either with deflection as illustrated in Figure 19C, or linearly, the cavity forming element 320 is enlarged, such as by introducing inflation media under pressure into the inflatable balloon 322. The cavity forming element 320 is thereafter reduced in cross sectional configuration, such as by aspirating inflation media from the inflatable balloon 322 to produce a cavity in the adjacent cancellous bone. The steerable injector 300 may thereafter by proximally withdrawn by a small distance, to position the distal opening 314 in communication with the newly formed cavity. Bone cement or other media may thereafter be infused into the cavity, as will be appreciated by those skill in the art.

[0135] At any time in the process, whether utilizing an injection needle having a cavity formation element or not, the steerable injector may be proximally withdrawn or distally advanced, rotated, and inclined to a greater degree or advanced into its linear configuration, and further distally advanced or proximally retracted, to position the distal opening 314 at any desired site for infusion of additional bone cement or other media. More than one cavity, such as two, or three or more, may be sequentially created using the cavity formation element, as will be appreciated by those of skill in the art [0136] The aforementioned bone cement implant procedure process eliminates the need for the external mixing of PMMA powder with MMA monomer. This mixing process sometimes entraps air in the dough, thus creating porosily in the hardened PMMA in the cancellous bone area. These pores weaken the PMMA. Direct mixing and hardening of the PMMA using an implant procedure such as the above eliminates this porosity since no air is -30- PCT/US2008/083698 2017204475 30 Jun2017 WO 2009/065085 entrapped in the injectate. This, too, eliminates further weakening, loosening, or migration of thePMMA.

[0137] While described herein primarily in the context of vertebroplasty, one of ordinary skill in the art will appreciate that the disclosed injection system can be used or modified in a wide range of clinical applications, such as, for example, other orthopedic applications such as kyphoplasty, treatment of any other bones, pulmonary, cardiovascular, gastrointestinal, gynecological, or genitourinary applications. While this invention has been particularly shown and described with references to embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention. For all of the embodiments described above, the steps of the methods need not be performed sequentially and the individual components of the devices may be combined permanently or be designed for removable attachment at the clinical site.

Throughout this specification, unless the context requires otherwise, the word "comprise" or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element or integer or method step or group of elements or integers or method steps but not the exclusion of any element or integer or method step or group of elements or integers or method steps.

Reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that this prior art forms part of the common general knowledge in any country. -31-

Claims (45)

CLAIMS:

1. A steerable vertebroplasty device, comprising: an elongate, tubular body, having a proximal end, a distal end, and a central lumen extending therethrough; a deflectable zone on the distal end of the tubular body, deflectable through an angular range; a handle on the proximal end of the tubular body; and a deflection control on the handle; and a cavity creating element carried by the deflectable zone.

2. A steerable vertebroplasty device as in Claim 1, wherein the deflection control comprises a rotatable element.

3. A steerable vertebroplasty device as in Claim 1, wherein die distal end comprises a distally facing exit port in communication with the central lumen.

4. A steerable vertebroplasty device as in Claim 1, wherein the distal end comprises a laterally feeing exit port in communication with the central lumen.

5. A steerable vertebroplasty device as in Claim 1, further comprising an actuator extending axially between the deflection control and the deflectable zone.

6. A steerable vertebroplasty device as in Claim 5, wherein the actuator comprises an axially moveable element.

7. A steerable vertebroplasty device as in Claim 1, wherein the cavity creating element comprises an inflatable balloon

8. A steerable vertebroplasty device as in Claim 7, wherein the inflatable balloon is disposed proximally of an exit port on the tubular body.

9. A steerable vertebroplasty device as in Claim 1, wherein the tubular body comprises a proximal zone and a distal, deflectable zone separated by a transition, and the transition is at least about 15% of the length of the tubular body from the distal end.

10. A steerable vertebroplasty device, comprising: an elongate, tubular body, having a proximal end, a distal end, and a central lumen extending therethrough; a deflectable zone on the distal end of the tubular body, deflectable through an angular range; a handle on the proximal end of the tubular body; and a deflection control on the handle; wherein the handle and deflection control are configured for single hand operation.

11. A steerable vertebroplasty device as in Claim 10, wherein the deflection control comprises a rotatable element.

12. A steerable vertebroplasty device as in Claim 10, wherein the distal end comprises a distally facing exit port in communication with the central lumea

13. A steerable vertebroplasty device as in Claim 10, wherein the distal end comprises a laterally facing exit port in communication with the central lumen.

14. A steerable vertebroplasty device as in Claim 10, further comprising an actuator extending axially between the deflection control and Ihe deflectable zone.

15. A steerable vertebroplasty device as in Claim 14, wherein the actuator comprises an axially moveable element.

16. A steerable vertebroplasty device as in Claim 10, further comprising a port on the proximal end of the vertebroplasty device, in communication with the central lumen.

17. A steerable vertebroplasty device as in Claim 16, wherein the deflectable zone is deflectable within a plane, and the port resides in the same plane.

IS. A steerable vertebroplasty device as in Claim 10, wherein the tubular body comprises a proximal zone and a distal, deflectable zone separated by a transition, and the transition is at least about 15% of the length of die tubular body fiom the distal end.

19. A system for performing vertebroplasty, comprising: a steerable injection needle with a proximal portion, elongate shaft, and a distal portion, the distal portion movable from a first substantially straight configuration to a second configuration not substantially coaxial with the proximal portion; and a cement dispensing pump comprising a first cartridge housing configured to house a cartridge containing two separate bone cement components; and a mixing nozzle for mixing the first bone cement component and second bone cement component material into a bone cement composite.

20. The system of Claim 19, further comprising a stylet for creating an access pathway in a pedicle.

21. The system of Claim 19, further comprising an introducer cannula

22. The system of Claim 19, further comprising the first bone cement component, wherein the first bone cement component comprises MMA.

23. The system of Claim 22, further comprising the second bone cement component, wherein the second bone cement component comprises from about 25% to about 35% by weight of bone particles.

24. The system of Claim 22, further comprising the second bone cement material, wherein the second bone cement material comprises at least about 35% weight percent of bone particles.

25. The system of Claim 19, wherein the steerable injection needle comprises an input port for receiving bone cement from the cement dispensing pump.

26. The system of Claim 25, wherein the input port comprises a Liter lock.

27. The system of Claim 19, wherein the steerable injection needle comprises an adjustment control configured to adjust the curvature of the distal end.

28. The system of Claim 19, wherein the steerable injection needle comprises an end cap on the distal end of the needle.

29. The system of Claim 19, wherein the steerable injection needle comprises a pull wire operably connected to the distal end of the needle.

30. The system of Claim 19, wherein foe steerable injection needle comprises a filter operably connected to a distal opening of the needle.

31. The system of Claim 19, wherein the distal portion of the steerable injection needle has a working length of at least about 20% of foe total working length of foe needle.

32. The system of Claim 19, wherein the steerable injection needle comprises a spring coil.

33. A closed vertebroplasty bone cement injection system, comprising: a cartridge containing at least a first chamber and a second chamber; a first bone cement component in the first chamber and a second bone cement component in the second chamber; a mixing chamber, for mixing the first and second bone cement components; an elongate injection needle, for directing bone cement into a treatment site in the spine; and a closed flow path for directing the first and second bone cement components from die first and second chambers, through the mixing chamber, through the injection needle and into the spine at the treatment site.

34. A closed vertebroplasty bone cement injection system as in Claim 33, wherein the cartridge is releaseably connected to die flow path.

35. A closed vertebroplasty bone cement injection system as in Claim 33, wherein the mixing chamber is releaseably connected to the flow path.

36. A closed vertebroplasty bone cement injection system as in Claim 33, wherein the injection needle is releaseably connected to the flow path.

37. A closed vertebroplasty bone cement injection system as in Claim 33, wherein the injection needle has a deflectable distal end.

38. 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 and a distal end, the distal end having a first configuration substantially coaxial with a long axis of the proximal end; rotating a control to deflect the distal end of the steerable injection needle to a second configuration that is not substantially coaxial with the long axis of the proximal end; and flowing bone cement through the steerable injection needle into the interior of the vertebral body.

39. (Original) The method of Claim 38, wherein the second configuration of the distal end of the steerable injection needle comprises a curved portion.

40. (Original) The method of Claim 38, wherein deflecting the distal end of the steerable injection needle is accomplished by exerting tension on a puli wire operably connected to the distal end.

41. (Original) The method of Claim 38, further comprising: providing a cement dispensing pump with a cartridge containing a first bone cement material and a second bone cement material out of contact with the first bone cement material, and a mixing nozzle; flowing the first bone cement material and the second bone cement material into Ihe mixing nozzle, creating a bone cement; and - flowing the bone cement into an input port of the steerable injection needle.

42. The method of Claim 38, wherein flowing bone cement through the steerable injection needle into the interior of the vertebral body comprises releasing a first bone cement within the interior of the vertebral body, the bone cement comprising at least 35% particles by weight

43. The method of Claim 42, wherein flowing bone cement through the steerable injection needle into the interior of the vertebral body additionally comprises releasing a second bone cement within the first bone cement, the second bone cement comprising less than about 35% particles by weight.

44. A method of injecting bone cement into a bone, comprising the steps of; providing a first chamber having a first bone cement component, and a second chamber having a second bone cement component, the first and second bone cement components formulated to form a hardenable bone cement following mixing; providing a mixing chamber for mixing the first and second bone cement components; providing an elongate, tubular injection needle; connecting the first and second bone cement chambers, the mixing chamber and the injection needle into a closed flow path; expressing first and second bone cement components through the mixing chamber, through the injection needle and into a first site; activating a control to deflect a distal end of the injection needle; and expressing first and second bone cement components through the mixing chamber, through the injection needle and into a second site.

45. A method of injecting bone cement as in Claim 44, wherein the first and second chambers are contained in a single cartridge.