System for deploying implants

Abstract

A system and method for deploying an implant. The introducer device includes an actuator, a shaft, a tension element coupled to the actuator, and an anchor coupled to the tension element. The implant includes a proximal neck configured to be removably disposed within a distal portion of the shaft. The proximal neck defines a notch sized to receive the anchor, such that the distal portion of the shaft covers the anchor and prevents separation of the anchor from the notch when the tension element is under tension. The actuator is configured to operate to release tension on the tension element to enable removal of the proximal neck from the distal portion of the shaft and separation of the anchor from the notch, thereby decoupling the implant from the introducer device. The anchor and the proximal notch may include complementary sloped surfaces to facilitate separation.

Description

[Technical Field]

[0001] This application claims priority to and the entire benefit of U.S. Provisional Patent Application No. 63 / 396,743, filed August 10, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to systems and methods for deploying implants, and more particularly, but not exclusively, to systems and methods for stabilizing vertebral bodies by providing an improved releasable engagement between an implant and an introducer device. [Background technology]

[0003] A common cause of back pain is vertebral compression fractures, in which weakened or injured vertebral bodies lose height or collapse. The weakening of the vertebral bodies can result from acute injury or, more often, from degenerative changes such as osteoporosis. Compression fractures often appear on lateral radiographs as a wedge-shaped deformity with greater height loss anteriorly.

[0004] One method of restoring vertebral body height involves deploying an implant within the vertebral body using an introducer device. The introducer device can be actuated to expand the implant, lifting or restoring the vertebral body height. The implant remains within the vertebral body to reinforce and maintain the structural integrity of the vertebral body at the lifted or restored height. During actuation of the introducer device and implant expansion, if the implant is not sufficiently rotationally secured to the introducer device, the implant may twist or become dislocated. This can lead to improper placement and / or expansion of the implant. Furthermore, bone cement is often delivered into and / or around the implant while it remains attached to the introducer device, interdigitating with the surrounding cancellous bone to harden and stabilize the implant within the vertebral body. Furthermore, if the implant and introducer device are not sufficiently secured, the bone cement may leak into undesired areas of the vertebral body and / or forces from the bone cement may cause the implant to prematurely detach from the introducer device. Such detachment can lead to implant misalignment or movement, resulting in improper placement of the implant.

[0005] Therefore, there is a need for an implant that remains sufficiently secured to an introducer device during deployment and then detaches in situ in an intuitive, ergonomic, and repeatable manner. Summary of the Invention

[0006] The systems and methods disclosed herein overcome the above-mentioned challenges. According to certain implementations, a system for stabilizing a vertebral body is provided. The system includes an introducer device and an implant. The introducer device includes a handle, an actuator, a shaft extending from the handle, a tension element coupled to the actuator and extending along the shaft, and an anchor coupled to the tension element. The implant includes a proximal neck configured to be removably disposed within a distal portion of the shaft. The proximal neck defines a notch sized to receive the anchor, and the distal portion of the shaft covers the anchor and prevents separation of the anchor from the notch when the tension element is under tension. The actuator is configured to actuate to release tension on the tension element to enable removal of the proximal neck from the distal portion of the shaft and separation of the anchor from the notch, thereby disconnecting the implant from the introducer device.

[0007] In certain implementations, the system includes an access cannula, an introducer device, and an implant. The introducer device includes a handle, an actuator, a shaft extending from the handle and deployable through the access cannula, a tension element coupled to the actuator and extending along the shaft, and an anchor coupled to the tension element. The anchor includes a first angled surface. The implant includes a proximal neck configured to be removably disposed within a distal portion of the shaft. The proximal neck includes a second angled surface and defines a notch sized to receive the anchor such that the first and second angled surfaces abut each other when the tension element is in a tensioned state. The actuator is configured to operate to release tension on the tension element to allow the first and second angled surfaces to slidably move past each other to facilitate removal of the anchor from the notch and decouple the implant from the introducer device.

[0008] In certain implementations, the system includes an introducer device and an implant. The introducer device includes a handle, an actuator, a shaft extending from the handle and having a distal portion defining a bore, a tension element coupled to the actuator and extending along the shaft, and an anchor coupled to the tension element. The implant includes a proximal neck removably extending into the distal portion of the shaft. The proximal neck defines a notch that engages with the anchor when the tension element is under tension. The actuator is configured to operate to release tension on the tension element, and the tension element is slidable within the handle a distance greater than the length of the distal portion through which the proximal neck removably extends to facilitate detachment of the implant from the introducer device.

[0009] In certain implementations, the system includes an introducer device and an implant. The introducer device includes a handle, an actuator, a shaft extending from the handle, a tension element coupled to the actuator and extending along the shaft, and an anchor coupled to the tension element. The implant includes a proximal neck configured to be removably disposed within a distal portion of the shaft. The proximal neck defines a notch sized to receive the anchor when the tension element is in a tensioned state. The proximal neck includes an anti-rotation feature radially offset from the notch and configured to engage a complementary anti-rotation feature on the distal portion of the shaft.

[0010] Advantages of the present disclosure will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a diagram of a portion of a spinal column showing three vertebrae separated by two intervertebral discs with implants deployed within the vertebral bodies. [Figure 2]1 is an elevational view of a system including an implant, an access cannula, and an introducer device operable to deploy the implant. [Figure 3] FIG. 3 is an enlarged exploded view of item 3 of FIG. 2 showing the introducer device separated from the implant. [Figure 4] 1 is a partial perspective view of a system in which a proximal neck of an implant is disposed within a distal portion of an introducer device, and a tensioning element of the introducer device can be in tension. [Figure 5] 1 is another partial perspective view of the system with the proximal neck of the implant separated from the distal portion and the anchor of the introducer device in the notch defined by the proximal neck. The tension element may be in a released state. [Figure 6] 10 is another partial perspective view of the system with the anchor removed or separated from the notch to disconnect the implant from the introducer device, and the tension element in a released state. [Figure 7]

[0023] Figure 10 is another partial perspective view of the system with the implant disconnected from the introducer device.

[0024] An anti-rotation feature is associated with each of the proximal neck and distal portion. [Figure 8] FIG. 1 is a perspective view of an implementation of an anchor. [Figure 9] FIG. 10 is a perspective view of another implementation of the anchor. [Figure 10A] FIG. 10 is a partial cross-sectional view of an introducer device with an actuator maintaining tension on a tension element. [Figure 10B] FIG. 10 is another partial perspective view of the introducer device with the actuator actuated to release tension on the tension element. [Figure 10C] FIG. 10 is another partial perspective view of the introducer device, where the stop member engages with the geometry of the handle to prevent further movement of the tension element within the handle. [Figure 11A] FIG. 10 is a partial cross-sectional view of an introducer device with an actuator maintaining tension on a tension element. [Figure 11B] FIG. 10 is another partial perspective view of the introducer device with the actuator actuated to release tension on the tension element. DETAILED DESCRIPTION OF THE INVENTION

[0012] 1, a diagram of vertebrae 14 separated by intervertebral discs 16 is provided. Each of the vertebrae 14 includes a vertebral body 12 that defines an interior region having cancellous bone. Also herein, in accordance with standard medical practice, reference may be made to anatomical directions: cephalad, toward the patient's head or upward; caudal, toward the patient's feet or downward; distal, toward the end of the device that is inserted first into the patient (or away from the practitioner); and proximal, toward the practitioner.

[0013] The system 10 for stabilizing the vertebral body 12 may include an access cannula 18, an introducer device 20, and an implant 22. Figure 1 shows the implant 22 in a deployed configuration that augments the vertebral body 12 to an elevated or restored height in a manner described below. When the vertebral body 12 is at the restored height, the endplates of the vertebral body 12 are spaced farther from each other than when at an unrestored height, which may reduce or eliminate pain and other sequelae associated with compression fractures.

[0014] The access cannula 18 includes a distal end 24 configured to be guided through the pedicle to reach the interior region of the vertebral body 12. A trocar (not shown) may include a solid shaft sized to be removably disposed within the access cannula 18. The trocar may include a length slightly greater than the length of the cannula so that the sharp tip of the trocar penetrates the cortical bone of the pedicle, preventing the excavation of tissue within the lumen of the access cannula 18. Once the distal end 24 of the access cannula 18 is positioned within the vertebral body 12, the trocar is removed. The access cannula 18 provides a working passageway along the axis into the interior region of the vertebral body 12. The inner diameter of the access cannula 18 is at least sufficient to receive the introducer device 20 and the implant 22 to be deployed. A cavity generator (not shown) may be guided through the working passageway into the vertebral body 12. The cavity generator may be operated (eg, rotated) to create a generally cylindrical cavity in the cancellous bone, the cavity being approximately the size of the implant 22 .

[0015] The introducer device 20 includes a proximal end, a distal end 28, and a shaft 30 extending distally from a handle 34. The shaft 30 has a distal portion 40 that extends to the distal end 28 of the introducer device 20. FIGS. 2-4 generally reflect that the distal portion 40 of the shaft 30 is coupled to the implant 22, and more specifically to the proximal neck 38 of the implant 22. The introducer device 20 may include the handle 34 and an implant actuator 36 (see FIGS. 2 and 10A-11B) configured to receive user input to deploy the implant 22. The implant actuator 36 may be operably coupled to the retention element 32 of the implant 22 and may be configured to pull the distal end of the implant 22 proximally. The upper and lower plates of the implant 22 move away from each other in a craniocaudal direction to restore the height of the vertebral body 12, in effect moving the implant 22 to the deployed configuration shown in FIG. 1. Further operation of the introducer device 20 and its interface with the retention element 32 of the implant 22 are described in commonly owned U.S. Patent No. 8,986,386, issued March 24, 2015, and U.S. Patent No. 9,414,933, issued August 16, 2016, the entire contents of each of which are incorporated herein by reference. In a procedure utilizing a bipedicular approach, the workflow is repeated through the contralateral pedicle, as reflected in FIG. 1 , which shows two systems 10 deploying two implants 22 within the same vertebral body 12. Alternatively, a unipedicular approach may involve utilizing a single system 10 with a single implant 22.

[0016] With the implant 22 deployed, the rod 26 of the introducer device 20 can be decoupled from the implant 22 and removed from the shaft 30 of the introducer device 20, with the shaft 30 remaining connected to the implant 22. Bone cement can be directed through the shaft 30 of the introducer device 20, which communicates with the opening in the retention element 32, and ejected into the vertebral body 12 surrounding the implant 22. Thus, the implant 22 must be sufficiently secured to the shaft 30 of the introducer device 20 during filling of the vertebral body 12 with the bone cement, which can involve significant viscous forces. Once the desired amount of bone cement has been placed, there is a limited time to decouple the introducer device 20 from the implant 22 and remove it from the access cannula 18 before the bone cement hardens.

[0017] The presently disclosed system 10 addresses the above-mentioned considerations by securely coupling the implant 22 to the introducer device 20 such that any unintentional slippage or disconnection between the implant 22 and the introducer device 20 is prevented. Furthermore, the introducer device 20 can be selectively separated from the implant 22 in an intuitive, ergonomic, and repeatable manner with little or no disturbance to the position of the implant 22 within the vertebral body 12. Referring now to FIG. 3 , the implant 22 includes a proximal neck 38, which can extend from or be formed as the proximal end of the implant 22. The implant 22 can be coupled to the introducer device 20 by placing the proximal neck 38 of the implant 22 in an opening or counterbore 54 defined by the distal portion 40 of the shaft 30. The distal portion 40 of the shaft 30 overlaps at least a portion of the proximal neck 38 of the implant 22.

[0018] The introducer device 20 includes a tension element 42 coupled to an actuator 43 (see FIGS. 10A-11B) and an anchor 44 coupled to the tension element 42. As described in more detail below, the anchor 44 is configured to engage the proximal neck 38 of the implant 22. When the anchor 44 of the introducer device 20 is engaged with the proximal neck 38 of the implant 22, the distal portion 40 of the shaft 30 covers at least a portion of the proximal neck 38 engaged by the anchor 44. In this manner, the distal portion 40 prevents the anchor 44 from separating or disengaging from the proximal neck 38. The proximal neck 38 may define a notch 62 sized to receive the anchor 44. The anchor 44 may be sized and contoured relative to the adjacent portion of the proximal neck 38 to define a generally semicircular contour. Thus, with anchor 44 disposed within notch 62, the inner diameter of distal portion 40 of shaft 30 closely covers anchor 44 received within notch 62 (see FIG. 4 ). Distal portion 40 of shaft 30 encases anchor 44, preventing anchor 44 from exiting or separating from notch 62 while proximal neck 38 is maintained within distal portion 40 of shaft 30.

[0019] The tension element 42, in cooperation with the above-described structure, facilitates coupling and detachment of the implant 22 from the introducer device 20. The tension element 42 may be removably disposed within the groove 64 in the proximal neck 38 to provide a generally semicircular profile. In a tensioned state, the tension element 42 prevents the proximal neck 38 from detaching from the distal portion 40, thereby preventing separation of the implant 22 from the introducer device 20. In a relaxed state, with little or no tension on the tension element 42, the tension element 42 facilitates detachment of the implant 22 from the introducer device 20 by allowing the proximal neck 38 to detach from the distal portion 40, after which the anchor 44 can exit or separate from the notch 62. Thus, the tension element 42 and anchor 44 are configured to prevent undesired separation of the implant 22 from the introducer device 20 and enable desired separation in an effective manner, which will be described in more detail. The tension element 42 may be a wire, band, braid, or the like, and may be made of any suitable material. It will be appreciated that the tension element 42 may include any number of wires, bands, or the like, and may be flexible or rigid.

[0020] The shaft 30 may define a passageway 46 extending longitudinally along the shaft 30, a shaft lumen 48, and an opening 50 extending between an outer surface 52 of the shaft 30 and the shaft lumen 48 (see FIG. 4 ). The passageway 46 may be defined in the outer surface 52 of the shaft 30. The tension element 42 is disposed within the passageway 46 and extends through the opening 50 out of the shaft lumen 48 of the distal portion 40 of the shaft 30. Alternatively, the passageway 46 may be defined along the shaft lumen 48, in which case the tension element 42 does not necessarily have to pass through the opening 50. It is contemplated that the shaft 30 may define any number of passageways extending in any direction. It is further contemplated that the shaft 30 and the proximal neck 38 may be generally tubular, as shown, or may have any suitable shape that facilitates coupling of the introducer device 20 and the implant 22.

[0021] Referring again to FIG. 3 , the proximal neck 38 of the implant 22 has a first length L1 that generally corresponds to the length the proximal neck 38 extends into the distal portion 40 of the shaft 30. This length may be defined between a wider proximal end of the proximal neck 38 and the proximal end of the implant 22. The tension element 42 has a second length L2, and the tension element 42 is configured to extend the second length L2 between a tensioned state and a relaxed state. In other words, the transition between the tensioned state and the relaxed state allows the anchor 44 to move away from the distal end of the shaft 30 by at least the second length L2. The second length L2 of the tension element 42 is greater than the first length L1 of the proximal neck 38. In this manner, in the released state, the second length L2 allows the anchor 44 to be spaced from the distal end of the shaft 30 a sufficient distance to allow the proximal neck 38 to be detached from the distal portion 40, after which the implant 22 can be separated from the notch 62.

[0022] The notch 62 and anchor 44 are shaped to facilitate secure engagement between the introducer device 20 and the implant 22 under tension and further shaped to facilitate separation under release. In the illustrated implementation, the anchor 44 includes a first angled surface 66 and the notch 62 includes a second angled surface 68. The second angled surface 68 of the notch 62 is configured to engage with the first angled surface 66 of the anchor 44. This arrangement encases the anchor 44 within the distal portion 40 of the shaft 30 and resists movement of the anchor 44. The first angled surface 66 and the second angled surface 68 are obliquely and complementary oriented to allow the anchor 44 to slidably exit the notch 62 by proximal movement of the proximal neck 38 relative to the distal portion 40 of the shaft 30. More specifically, first angled surface 66 and second angled surface 68 slide along one another when tension element 42 is fully extended in the relaxed state. As introducer device 20 is moved further proximally, tension element 42 pulls on anchor 44, which then slides out of notch 62 and is removed along with access cannula 18 with introducer device 20. It should be understood that notch 62 and anchor 44 may assume any suitable complementary shape, configuration, geometry, etc.

[0023] 4-6 illustrate various stages of coupling and detachment between introducer device 20 and implant 22. Starting with FIG. 4, implant 22 is coupled to introducer device 20. Proximal neck 38 is disposed within distal portion 40. Anchor 44 is disposed within notch 62. A first angled surface 66 of anchor 44 and a second angled surface 68 of proximal neck 38 abut one another. Distal portion 40 covers anchor 44 to prevent anchor 44 from exiting notch 62. Tensioning element 42 can be in a tensioned state (or a relaxed state prior to movement of introducer device 20). In the tensioned state, tensioning element 42 is tensioned and / or pulled proximally. In the tensioned state, the tensioning element 42 pulls the anchor 44 longitudinally such that the first angled surface 66 of the anchor 44 and the second angled surface 68 of the proximal neck 38 abut one another. The implant 22 and the introducer device 20 do not move substantially relative to one another while the tensioning element 42 is in the tensioned state. In this manner, the implant 22 is prevented from separating from the introducer device 20, and the user can manipulate the introducer device 20 with corresponding movement of the implant 22.

[0024] Actuator 43 operates to move tension element 42 from a tensioned state to a released state. Actuator 43 releases the tension on tension element 42, allowing tension element 42 to move relative to handle 34 and relative to shaft 30. Figure 5 shows tension element 42 in the released state and the user moving introducer 20 away from implant 22 to remove it from access cannula 18. When handle 34 is moved proximally, tension element 42 can still move relative to handle 34, allowing anchor 44 to still be disposed in notch 62.

[0025] As mentioned, further proximal movement of introducer device 20 eventually causes tension element 42 to pull anchor 44, which then slides out of notch 62 and is removed along with access cannula 18 carrying introducer device 20. In other words, actuation of tension element 42 from a tensioned state to a released state allows first angled surface 66 of anchor 44 and second angled surface 68 of notch 62 to move past each other, facilitating removal of anchor 44 from notch 62. FIG. 6 shows implant 22 detached from introducer device 20. Such functionality is particularly advantageous due to the constraint that a user may manipulate introducer device 20 while it is disposed through access cannula 18. In other words, shaft 30 of introducer device 20 is slidably disposed through access cannula 18, and thus a user may withdraw introducer device 20 only in the proximal direction. Anchor 44 and notch 62 are configured to be separable solely by a proximal force from tension element 42 to anchor 44. First ramp 66 and second ramp 68 effectively convert the axial force into a combined axial-radial force to move anchor 44 upwardly within notch 62 and remove it.

[0026] In certain configurations, the shaft 30 of the introducer device 20 may include geometries, i.e., an abutment feature 56 and / or an anti-rotation feature 72, configured to further secure the implant 22 to the introducer device 20 under tension. The abutment feature 56 may be a surface from a counterbore extending a third length L3 (see FIG. 7 ) from the inner surface 58 of the shaft 30. The third length L3 may be the same or substantially the same distance as the first length L1 such that the abutment feature 56 abuts the proximal end 70 of the proximal neck 38 of the implant 22. The anti-rotation feature 72 may be radially offset from the notch 62 and may include a flat feature 74. A complementary flat feature 75 may be formed in the opening 54 of the shaft 30. With the proximal neck 38 disposed within the distal portion 40, the flat features 74, 75 engage to prevent rotation of the implant 22 relative to the introducer device 20. As shown, the proximal neck 38 of the implant 22 and the opening 54 of the shaft 30 are substantially D-shaped in axial cross-section. It should be understood that the proximal neck 38 and the distal portion 40 of the introducer device 20 may include additional geometric features to prevent rotation of the implant 22 relative to the introducer device 20.

[0027] The proximal neck 38 may define an implant lumen 60 configured to be coaxially disposed with the shaft lumen 48. Additionally, the handle 34 may be cannulated to provide fluid communication between the handle 34, the shaft lumen 48, and the implant lumen 60. The implant lumen 60 is in fluid communication with the retention element 32, which in turn includes an opening for directing bone cement into the vertebral body adjacent to the implant 22. Thus, once the implant 22 is deployed, the rod 26 may be decoupled from the retention element 32, a portion of the introducer device 20 may be removed, and bone cement may then be directed through the shaft lumen 48 and the implant lumen 60. It should be noted that the integration of the anchor-type mechanism of the present disclosure is achieved without requiring redesign of specific components and bone cement delivery workflows familiar to users.

[0028] 8 and 9, an exemplary configuration of anchor 44 is provided. Anchor 44 includes at least two arcuate surfaces 79 contoured to provide a generally semicircular contour of proximal neck 38 such that, when anchor 44 is disposed within notch 62, the inner diameter of distal portion 40 can be slidably disposed thereover. FIG. 8 shows anchor 44 defining a recess 76 configured to receive a portion of tension element 42. In other words, tension element 42 can be coupled to anchor 44 at a location within recess 76. Tension element 42 can be coupled to anchor 44 in any suitable manner, such as, for example, soldering, laser welding, adhesive bonding, or an interference fit. Anchor 44 can further define a groove 77 adjacent recess 76 for receiving a portion of tension element 42. Groove 77 can extend to second angled surface 68. Groove 77 positions tension element 42 below top surface 81 of anchor 44, which, together with anchor 44 disposed within notch 62, further facilitates the generally semicircular profile of proximal neck 38. The implementation in FIG. 9 shows anchor 44 including a head portion 78 and a tail portion 80 extending from head portion 78. Head portion 78 may include second angled surface 68, and tail portion 80 may extend from second angled surface 68. Tension element 42 may be coupled to tail portion 80.

[0029] FIG. 2 shows the actuator 43 in its general form, disposed on the handle 34. Referring now to FIGS. 10A-11B, a more specific exemplary configuration of the actuator 43 is shown, which, in a tensioned state, maintains tension on the tension element 42 and, when actuated, releases tension on the tension element 42. As noted, the tension element 42 is movable relative to the handle 34 in a released state. For example, the tension element 42 may be slidable within the handle 34. Thus, to place the tension element 42 in a tensioned state, a user may pull the tension element 42 proximally within the handle 34. The user may simultaneously actuate the actuator 43 to enable the tension element 42 to be pulled proximally. Pulling proximally may be accomplished by the proximal end of the tension element 42 being exposed (i.e., external to the handle), which the user may pinch and pull taut (see FIGS. 11A and 11B). After pulling sufficiently to feel resistance from the engagement between anchor 44 and notch 62, the user may release actuator 43 to maintain tension element 34 in a tensioned state. Alternatively, a tension actuator (not shown) or other mechanism may be disposed in handle 34 and configured to pull tension element 42 proximally within handle 34 until resistance is achieved.

[0030] As shown in FIGS. 10A-10C, the actuator 43 is a push button 82. A biasing member 84 may be coupled to the push button 82, such that actuation of the push button 82 resists the bias of the biasing member 84. When the push button 82 is not actuated, the push button 82 is biased to maintain the tension element 42 in a tensioned state (or in its current state if not tensioned). More specifically, the actuator 43 is configured to tighten (clamp) the tension element 42 within the handle 34 to maintain the tension element 42 in a tensioned state (see FIG. 10A). A user may actuate the push button 82 by effectively grasping the handle 34 and exerting a downward force on the push button 82. Actuation of the push button 82 releases the tension element 42 within the handle 34, allowing the tension element 42 to slide relative to the handle 34 (see FIG. 10B). Although the push button 82 is illustrated as being located on the top side of the introducer device 20, it will be understood that the push button 82 may be located on any side of the introducer device 20 and / or may be located anywhere relative to the introducer device 20, including any component of the introducer device 20, such as the handle 34. For example, the push button 82 may be located on the left side of the introducer device 20 so that a user holding the handle 34 in their right hand can apply a lateral force to the push button 82 with their thumb. FIGS. 11A-11B show the internal components of the handle 34, where the actuator 43 is a lever. The actuator 43 may include a stem 88 and a biasing member 84 coupled to the stem 88. The lever is coupled to the stem 88 and extends externally of the handle 34 (not shown). The biasing member 84 may be a torsion spring. Actuation of lever 86 against the bias of biasing member 84 may maintain tension element 42 in a tensioned (or current) state by twisting or wrapping tension element 42 around mandrel 88 (see FIG. 11A). Lever 86 may be actuated by twisting, rotating, pulling, bending, etc. Releasing lever 86 causes biasing member 84 to cause opposing movement of lever 86 and mandrel 88, allowing tension element 42 to move within handle 34 (see FIG. 11B).It should be understood that actuator 43 may be two or more actuators and / or any type of component capable of releasing tension on a tension element, such as, but not limited to, a slide switch, a knob, a palm or finger trigger, etc.

[0031] As previously mentioned, the tension element 42 may be slidable within the handle 34 a distance greater than the length of the distal portion 40 through which the proximal neck 38 removably extends. The tension element 42 may include a stop member 90 at its proximal end to prevent detachment of the tension element 42 from the handle 34. For example, the stop member 90 may be a blocking member configured to interfere with the geometry of the shaft lumen 48 or the interior of the handle 34 (see FIG. 10C ). In another example, the stop member 90 may be a retention loop. In the released state, proximal movement of the introducer device 20 causes the tension element 42 to pull on the anchor 44, which then slides out of the notch 62 and is removed along with the access cannula 18 that carries the introducer device 20. The end-ended stop member 90 may provide a proximal force pulling on the anchor 44 (as opposed to the tension element 42 continuing to slide within the handle 34). Once anchor 44 is separated from notch 62, anchor 44 may be free to sag or hang from tension element 42. When introducer device 20 is removed from access cannula 18, anchor 44 is withdrawn through access cannula 18. Access cannula 18 then remains within the pedicle to provide a working channel through which any additional steps of the procedure may be performed, as mentioned.

[0032] Further inventive aspects of the present disclosure can be made with reference to the following exemplary clauses.

[0033] Clause 1 1. A method for stabilizing a vertebral body with an implant releasably coupled to an introducer device having an actuator, a tension element coupled to the actuator, and an anchor coupled to the tension element, the implant including a proximal neck defining a notch; providing a working channel into the vertebral body with an access cannula; directing the implant through the access cannula with the tensioning element in a tensioned state, wherein a distal portion of the shaft covers the anchor while the tensioning element is in a tensioned state, thereby preventing the anchor from separating from the notch; actuating the actuator to move the tension element to a released state in which tension on the element is released; With the tension element in the released state, beginning to withdraw the introducer device from the access cannula, wherein the proximal neck of the implant is exposed from the distal portion of the shaft to allow separation of the anchor from the notch and detachment of the implant from the introducer device; withdrawing the introducer device from the access cannula; A method comprising:

[0034] Clause 2 10. The method of claim 1, further comprising the step of delivering bone cement through an implant cavity defined by the proximal neck prior to the step of actuating the actuator.

[0035] Clause 3 3. The method of clause 2, further comprising rotating the introducer device to rotate the implant having an anti-rotation feature disposed at the proximal neck of the implant and within the distal portion of the shaft.

[0036] Clause 4 tensioning the tension element to move the tension element into the tensioned state while simultaneously actuating the actuator; 4. The method of any one of clauses 1 to 3, further comprising: releasing the actuator to maintain the tension element in the tensioned state.

[0037] Clause 5 actuating an implant actuator to expand the implant; Detaching the rod of the introducer device from the implant; 5. The method of any one of clauses 1 to 4, further comprising the step of removing the rod through the proximal neck of the implant.

[0038] While the foregoing description sets forth several configurations, the configurations described herein are not intended to be exhaustive. The terminology used is intended to be in the nature of words of description rather than limitation, and many variations and modifications are possible in light of the above disclosure. The features of the described configurations may and can be employed in a variety of other surgical and non-surgical applications, particularly where it is desirable to prevent unintended implant detachment. For example, the systems described herein may be used to deploy implants for orthopedic surgery, ENT surgery, and the like.

Claims

1. 1. A system for deploying an implant, comprising: an introducer device including a handle, an actuator, a shaft extending from the handle, a tension element coupled to the actuator and extending along the shaft, and an anchor coupled to the tension element; an implant including a proximal neck configured to be removably disposed within a distal portion of the shaft, the proximal neck defining a notch sized to receive the anchor, the distal portion of the shaft covering the anchor to prevent separation of the anchor from the notch when the tension element is under tension; Equipped with the actuator is configured to operate to release tension on the tension element to allow detachment of the proximal neck from the distal portion of the shaft and separation of the anchor from the notch, thereby disconnecting the implant from the introducer device. system.

2. 2. The system of claim 1, wherein the anchor further comprises a first angled surface and the proximal neck further comprises a second angled surface configured to engage the first angled surface when the tension element is in the tensioned state.

3. 3. The system of claim 2, wherein the first angled surface is oriented obliquely relative to a longitudinal axis of the shaft such that proximal movement of the proximal neck relative to the distal portion of the shaft allows the anchor to slidably exit the notch.

4. 1. A system for deploying an implant, comprising: an access cannula; an introducer device including a handle, an actuator, a shaft extending from the handle and deployable through the access cannula, a tension element coupled to the actuator and extending along the shaft, and an anchor coupled to the tension element, the anchor including a first angled surface; an implant including a proximal neck configured to be removably disposed within a distal portion of the shaft, the proximal neck including a second angled surface and defining a notch sized to receive the anchor such that the first angled surface and the second angled surface abut one another when the tensioning element is under tension; Equipped with the actuator is configured to operate to release tension on the tension element to allow the first angled surface and the second angled surface to slidably move past one another to facilitate removal of the anchor from the notch and to decouple the implant from the introducer device. system.

5. 5. The system of claim 4, wherein the anchor further comprises a head portion including the first angled surface and a tail portion extending from the head portion, the tension element being coupled to the tail portion.

6. The system of claim 1 , wherein the tension element is configured to slide within the handle when the tension on the tension element is released.

7. 1. A system for deploying an implant, comprising: an introducer device including a handle, an actuator, a shaft extending from the handle and having a distal portion defining a bore, a tension element coupled to the actuator and extending along the shaft, and an anchor coupled to the tension element; an implant including a proximal neck removably extending into the distal portion of the shaft, the proximal neck defining a notch into which the tension element engages the anchor under tension; Equipped with the actuator is configured to operate to release tension on the tension element, the tension element being slidable within the handle a distance greater than the length of the distal portion through which the proximal neck removably extends to facilitate detachment of the implant from the introducer device. system.

8. 8. The system of claim 6 or 7, wherein a distal end of the tension element is coupled to the anchor, and the tension element further includes a proximal end defining a stop member, the stop member configured to engage the actuator to prevent detachment of the tension element from the handle.

9. The system of claim 1 , wherein the proximal neck further comprises an anti-rotation feature disposed radially offset from the notch.

10. The system of claim 9 , wherein the proximal neck is substantially D-shaped in axial cross-section and has a flat feature that provides the anti-rotation feature.

11. 1. A system for deploying an implant, comprising: an introducer device including a handle, an actuator, a shaft extending from the handle, a tension element coupled to the actuator and extending along the shaft, and an anchor coupled to the tension element; an implant including a proximal neck configured to be removably disposed within a distal portion of the shaft, the proximal neck defining a notch sized to receive the anchor with the tension element in a tensioned state; Equipped with the proximal neck includes an anti-rotation feature disposed radially offset from the notch and configured to engage a complementary anti-rotation feature on the distal portion of the shaft. system.

12. The system of claim 11 , wherein the proximal neck is substantially D-shaped in axial cross-section and has a flat feature that provides the anti-rotation feature.

13. 13. The system of claim 1, wherein the shaft of the introducer device defines a passageway extending longitudinally along the shaft, and the tension element is disposed within the passageway.

14. 14. The system of claim 13, wherein the passage is defined in an outer surface of the shaft, the shaft being tubular and further defining a shaft lumen and an opening extending between the outer surface and the shaft lumen, the tension element passing through the opening and extending out of the shaft lumen at the distal portion of the shaft.

15. 14. The system of any one of claims 1 to 13, wherein the handle is cannulated, the shaft is tubular and defines a shaft lumen, the proximal neck is tubular and defines an implant lumen, and the cannulated handle, shaft lumen, and implant lumen are coaxially arranged and configured to receive instrumentation for deployment of the implant within a vertebral body.

16. 16. The system of any one of claims 1 to 15, wherein the proximal neck of the implant defines a groove, and the tension element is removably disposed within the groove with the anchor disposed within the notch.

17. The system of claim 1 , wherein the anchor defines a recess configured to receive a portion of the tension element.

18. 18. The system of any one of claims 1 to 17, wherein the actuator is a push button, further comprising a biasing member coupled to the push button, wherein actuation of the push button against the bias of the biasing member is configured to tighten the tension element within the handle to maintain the tensioned state.

19. 18. The system of any one of claims 1 to 17, wherein the actuator is a lever and further comprises a stem and a biasing member coupled to the lever, wherein actuation of the lever against the bias of the biasing member is configured to twist the tension element about the stem to maintain the tension element in the tensioned state.

20. 20. The system of any one of claims 1 to 19, wherein the implant is an intraspinal implant, and the system is configured to deploy the intraspinal implant to stabilize a vertebral body.

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