System for deploying an implant

Abstract

Systems and methods for deploying implants. The introducer device includes an actuator, a shaft, a tensioning element coupled to the actuator, and an anchor coupled to the tensioning element. The implant includes a proximal neck configured to be removably disposed within the distal portion of the shaft. The proximal neck defines a recess dimensioned to receive the anchor such that the distal portion of the shaft covers the anchor and prevents separation of the anchor from the recess when the tensioning element is in a tensioned condition. The actuator is configured to be actuated to release tension on the tensioning element to allow removal of the proximal neck from the distal portion of the shaft and separation of the anchor from the notch to separate the implant from the introducer device. The anchor and the proximal notch may include complementary sloped surfaces to facilitate the separation.

Description

[0001] Related Applications

[0002] This application claims priority to and all benefits of U.S. Provisional Patent Application No. 63 / 396,743, filed on August 10, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure is directed to systems and methods for deploying implants. More particularly, but not exclusively, the present disclosure relates to systems and methods for stabilizing a vertebral body by providing improved releasable engagement between an implant and an introducer device. Background Art

[0004] A common cause of back pain is a vertebral compression fracture, in which a weakened or injured vertebra loses height or collapses. The weakening of the vertebra may be due to an acute injury or, more commonly, due to degenerative changes such as osteoporosis. Compression fractures often show a wedge-shaped deformity on a lateral radiograph, with a greater loss of anterior height.

[0005] The way to restore the height of the vertebral body includes using an introducer device to deploy an implant in the vertebral body. The introducer device can be actuated to expand the implant, thereby raising or restoring the height of the vertebral body. The implant remains in the vertebral body to enhance and maintain the structural integrity of the vertebral body when it is raised or restored in height. During the actuation of the guide device and the expansion of the implant, if the implant is not fully rotationally fixed to the guide device, the implant may be twisted or misplaced. This may cause the implant to be improperly placed and / or expanded. In addition, usually when the implant is still attached to the introducer device, bone cement can be delivered to the implant and / or around it to be combined with the surrounding cancellous bone, thereby solidifying and stabilizing the implant in the vertebral body. Similarly, if the implant and the introducer device are not fully fixed, the bone cement may leak into the undesirable area of ​​the vertebral body and / or the force from the bone cement may prematurely disengage the implant from the introducer device. This disengagement may cause the implant to shift or move, thereby causing the implant to be incorrectly positioned.

[0006] Therefore, there is a need to keep the implant adequately secured to the introducer device during deployment and then detach in situ in an intuitive, ergonomic, and reproducible manner. Summary of the invention

[0007] The systems and methods disclosed herein overcome the above challenges. According to certain embodiments, 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 tensioning element connected to the actuator and extending along the shaft, and an anchor connected to the tensioning element. The implant includes a proximal neck configured to be removably arranged in the distal portion of the shaft. The proximal neck defines a recess, the size of which is designed to receive the anchor so that the distal portion of the shaft covers the anchor and prevents the anchor from separating from the recess when the tensioning element is in a tensioned state. The actuator is configured to be actuated to release the tension on the tensioning element, thereby allowing the proximal neck to be removed from the distal portion of the shaft and the anchor to separate from the recess, so that the implant is disengaged from the introducer device.

[0008] In certain embodiments, the system includes an access sleeve, an introducer device, and an implant. The introducer device includes a handle, an actuator, a shaft extending from the handle and capable of being deployed through the access sleeve, a tensioning element connected to the actuator and extending along the shaft, and an anchor connected to the tensioning element. The anchor includes a first inclined surface. The implant includes a proximal neck configured to be removably arranged in the distal portion of the shaft. The proximal neck includes a second inclined surface and defines a recess, the size of the recess being designed to receive the anchor so that the first inclined surface and the second inclined surface abut each other when the tensioning element is in a tensioned state. The actuator is configured to be actuated to release the tension on the tensioning element, thereby allowing the first inclined surface and the second inclined surface to slidably move past each other to facilitate the anchor to pop out of the recess and the implant to disengage from the introducer device.

[0009] In certain embodiments, the system includes an introducer device and an implant. The introducer device includes a handle, an actuator, a shaft extending from the handle and including a distal portion defining a hole, a tensioning element coupled to the actuator and extending along the shaft, and an anchor coupled to the tensioning element. The implant includes a proximal neck that removably extends within the distal portion of the shaft. The proximal neck defines a recess that engages the anchor when the tensioning element is in a tensioned state. The actuator is configured to be actuated to release tension on the tensioning element, wherein the distance the tensioning element can slide within the handle is greater than the length of the distal portion within which the proximal neck removably extends, so as to facilitate disengagement of the implant from the introducer device.

[0010] In certain embodiments, the system includes an introducer device and an implant. The introducer device includes a handle, an actuator, a shaft extending from the handle, a tensioning element coupled to the actuator and extending along the shaft, and an anchor coupled to the tensioning element. The implant includes a proximal neck configured to be removably disposed within a distal portion of the shaft. The proximal neck defines a recess sized to receive the anchor when the tensioning element is in a tensioned state. The proximal neck includes an anti-rotation structure positioned radially offset from the recess and configured to engage a complementary anti-rotation structure of the distal portion of the shaft. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Advantages of the present invention may be better understood by referring to the following detailed description taken in conjunction with the accompanying drawings, whereby the advantages of the present invention will be readily appreciated.

[0012] Figure 1 is a schematic diagram of a portion of the spinal column showing three vertebrae separated by two intervertebral discs with an implant deployed within the vertebral body.

[0013] Figure 2 is an elevational view of a system including an implant, an access cannula, and an introducer device actuated to deploy the implant.

[0014] Figure 3 is Figure 2 An enlarged exploded view taken at reference numeral 3 in FIG. 1 shows the introducer device spaced apart from the implant.

[0015] Figure 4 is a partial perspective view of the system, wherein the proximal neck of the implant is disposed within the distal portion of the introducer device. The tensioning element of the introducer device may be in a tensioned state.

[0016] Figure 5 is another partial perspective view of the system, wherein the proximal neck is separated from the distal portion and the anchor of the introducer device is positioned within a recess defined by the proximal neck. The tensioning element may be in a released state.

[0017] Figure 6 is another partial perspective view of the system, wherein the anchor has been ejected or separated from the notch, allowing the implant to be disengaged from the introducer device. The tensioning element is in a released state.

[0018] Figure 7 is another partial perspective view of the system with the implant separated from the introducer device.An anti-rotation feature is associated with each of the proximal neck and the distal portion.

[0019] Figure 8 is a perspective view of an embodiment of an anchor.

[0020] Fig. 9is a perspective view of another embodiment of an anchor.

[0021] Fig. 10A is a partial cross-sectional view of an introducer device wherein an actuator maintains tension on a tensioning element.

[0022] Fig. 10B is another partial perspective view of the introducer device with the actuator actuated to release tension on the tensioning element.

[0023] Fig. 10C is another partial perspective view of the introducer device with a stop member engaging the geometry of the handle to prevent further movement of the tensioning element within the handle.

[0024] Fig.11A is a partial cross-sectional view of an introducer device wherein an actuator maintains tension on a tensioning element.

[0025] Fig. 11B is another partial perspective view of the introducer device with the actuator actuated to release tension on the tensioning element. DETAILED DESCRIPTION

[0026] refer to Figure 1 , provides a schematic diagram of vertebrae 14 separated by intervertebral discs 16. Each vertebra 14 includes a vertebral body 12, which defines an interior region having cancellous bone. According to standard medical practice, reference may also be made herein to anatomical directions; i.e., cranial or head side toward the patient's head or upward, caudal side toward the patient's feet or downward, distal side toward the end of the device that is first inserted into the patient's body (or away from the physician), and proximal side toward the physician.

[0027] The system 10 for stabilizing a vertebral body 12 may include an access cannula 18 , an introducer device 20 , and an implant 22 . Figure 1 The implant 22 is shown in a deployed configuration, which expands the vertebral body 12 to an elevated or restored height in a manner described below. When the vertebral body 12 is at a restored height, the end plates of the vertebral body 12 are spaced farther apart from each other than when the height is not restored, which can reduce or eliminate pain and other sequelae associated with compression fractures.

[0028] The access cannula 18 includes a distal end 24 configured to be guided through the pedicle to enter 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 length of the trocar may be slightly greater than the length of the cannula so that the sharp tip of the trocar pierces the cortical bone of the pedicle and the trocar prevents tissue coring from entering the lumen of the cannula 18. Once the distal end 24 of the access cannula 18 is positioned within the vertebral body 12, the trocar may be removed. The access cannula 18 provides a working channel leading to the interior region of the vertebral body 12 along the axis. 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 channel into the vertebral body 12. The cavity generator may be operated (e.g., rotated) to create a generally cylindrical cavity in the cancellous bone that is close to the size of the implant 22.

[0029] 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 extending to the distal end 28 of the introducer device 20. Figure 2-4 The distal portion 40 of the shaft 30 is generally coupled to the implant 22, and more specifically to the proximal neck 38 of the implant 22. The introducer device 20 may include a handle 34 and an implant actuator 36 configured to receive user input to deploy the implant 22 (see Figure 2 and Figures 10A-11B ). The implant actuator 36 can be operably coupled to the retaining element 32 of the implant 22 and 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 the cranial and caudal directions to restore the height of the vertebral body 12, in effect moving the implant 22 to the distal end of the vertebral body 12. Figure 1 The deployed configuration is shown. Additional operation of the introducer device 20 and its connection to the retaining element 32 of the implant 22 is described in commonly owned U.S. Pat. No. 8,986,386 issued on March 24, 2015 and U.S. Pat. No. 9,414,933 issued on August 16, 2016, each of which is incorporated herein by reference in its entirety. In a procedure utilizing a bipedicular approach, the workflow is repeated through the contralateral pedicle, which is reflected in Figure 1 , which shows two systems 10 deploying two implants 22 within the same vertebral body 12. Alternatively, a single pedicle approach may include utilizing a single system 10 with a single implant 22.

[0030] After the implant 22 is deployed, the rod 26 of the guide device 20 can be disengaged from the implant 22 and removed from the shaft 30 of the guide device 20. The shaft 30 remains coupled to the implant 22. Bone cement can be directed through the shaft 30 of the introducer device 20, which is in communication with the aperture of the retaining element 32, and out into the vertebral body 12 around the implant 22. Therefore, during the process of impregnating the vertebral body 12 with bone cement, the implant 22 must be adequately fixed to the shaft 30 of the introducer device 20, which may be associated with relatively large stiction forces. Once the desired amount of bone cement has been placed, there is a limited time period to disengage the introducer device 20 from the implant 22 and remove it from the access cannula 18 before the bone cement hardens.

[0031] The system 10 of the present disclosure addresses the above-mentioned concerns by securely coupling the implant 22 to the introducer device 20 such that any accidental displacement or disengagement between the implant 22 and the introducer device 20 is prevented. In addition, the introducer device 20 can be selectively separated from the implant 22 in an intuitive, ergonomic, and repeatable manner with little or no disruption to the position of the implant 22 within the vertebral body 12. Referring now to Figure 3 , the implant 22 includes a proximal neck 38 that can extend from or be formed as a proximal portion of the implant 22. The implant 22 can be coupled to the introducer device 20 by positioning the proximal neck 38 of the implant 22 within 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.

[0032] The introducer device 20 includes a coupling to an actuator 43 (see Figures 10A-11B ) and an anchor 44 coupled to the tensioning element 42. As will be discussed 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 engages 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 way, the distal portion 40 prevents the anchor 44 from separating or disengaging from the proximal neck 38. The proximal neck 38 may define a recess 62 sized to receive the anchor 44. The size and profile of the anchor 44 may be designed to conform to adjacent portions of the proximal neck 38 to define a generally semicircular profile. Therefore, when the anchor 44 is located within the recess 62, the inner diameter of the distal portion 40 of the shaft 30 snugly covers the anchor 44 received within the recess 62 (see Figure 4 ). The distal portion 40 of the shaft 30 surrounds the anchor 44 and prevents the anchor 44 from popping out or separating from the recess 62, while the proximal neck 38 is retained within the distal portion 40 of the shaft 30.

[0033] The tensioning element 42 cooperates with the aforementioned structure to facilitate the coupling and disconnection of the implant 22 and the introducer device 20. The tensioning element 42 can be removably arranged in the groove 64 of the proximal neck 38 to provide a generally semicircular profile. In the tensioned state, the tensioning element 42 prevents the implant 22 from being separated from the introducer device 20 by preventing the proximal neck 38 from being removed from the distal portion 40. In the released state with little or no tension on the tensioning element 42, the tensioning element 42 helps to disconnect the implant 22 from the introducer device 20 by allowing the proximal neck 38 to be removed from the distal portion 40, after which the anchor 44 can pop out or separate from the recess 62. Therefore, the tensioning element 42 and the anchor 44 are configured to prevent the implant 22 from being undesirably separated from the introducer device 20, and to allow the desired separation to be achieved in an efficient manner that will be described in more detail. The tensioning element 42 can be a wire, a ribbon, a braid, etc., and is made of any suitable material. It should be appreciated that the tensioning element 42 may include any number of wires, ribbons, etc., and may be flexible or rigid.

[0034] The shaft 30 may define a passage 46 extending longitudinally along the shaft 30, a shaft lumen 48, and an aperture 50 extending between an outer surface 52 of the shaft 30 and the shaft lumen 48 (see Figure 4 ). The channel 46 can be defined in the outer surface 52 of the shaft 30. The tensioning element 42 is disposed in the channel 46 and extends from the shaft lumen 48 of the distal portion 40 of the shaft 30 through the aperture 50. Alternatively, the channel 46 can be defined along the shaft lumen 48, wherein the tensioning element 42 may not necessarily pass through the aperture 50. It is contemplated that the shaft 30 can define any number of channels extending in any direction. It is further contemplated that the shaft 30 and the proximal neck 38 can be generally tubular as shown or have any suitable shape to facilitate the connection of the introducer device 20 and the implant 22.

[0035] Reference again Figure 3 , the proximal neck 38 of the implant 22 has a first length L1, which generally corresponds to the length of the proximal neck 38 extending into the distal portion 40 of the shaft 30. The length can be defined between the widened proximal portion located distal to the proximal neck 38 and the proximal end of the implant 22. The tensioning element 42 has a second length L2, and the tensioning element 42 is configured to extend to the second length L2 between the tensioned state and the released state. In other words, the transition between the tensioned state and the released state is configured to allow the anchor 44 to move at least the second length L2 away from the distal end of the shaft 30. The second length L2 of the tensioning element 42 is greater than the first length L1 of the proximal neck 38. Thus, in the released state, the second length L2 allows the anchor 44 to move a sufficient distance away from the distal end of the shaft 30 to allow the proximal neck 38 to be removed from the distal portion 40, after which the implant 22 can be separated from the recess 62.

[0036] The shapes of the recess 62 and the anchor 44 are designed to facilitate secure engagement between the guide 20 and the implant 22 in the tensioned state, and they are also designed to facilitate separation in the released state. In the illustrated embodiment, the anchor 44 includes a first inclined surface 66 and the recess 62 includes a second inclined surface 68. The second inclined surface 68 of the recess 62 is configured to engage the first inclined surface 66 of the anchor 44. With the anchor 44 enclosed within the distal portion 40 of the shaft 30, this arrangement applies resistance to the movement of the anchor 44. The first inclined surface 66 and the second inclined surface 68 are complementary oriented at a certain angle so as to allow the anchor 44 to slidably pop out of the recess 62 as the proximal neck 38 moves proximally relative to the distal portion 40 of the shaft 30. More specifically, once the tensioning element 42 is fully extended in the released state, the first inclined surface 66 and the second inclined surface 68 slide along each other. Further proximal movement of the introducer device 20 causes the tensioning element 42 to pull the anchor 44, which is then slidably ejected from the notch 62 for removal with the access cannula 18 with the introducer device 20. It should be appreciated that the notch 62 and anchor 44 may take any suitable complementary shapes, configurations, profiles, etc.

[0037] Figure 4-6 Various stages of coupling and disconnection of introducer device 20 and implant 22 are shown. Figure 4 Initially, the implant 22 is coupled to the introducer device 20. The proximal neck 38 is disposed within the distal portion 40. The anchor 44 is disposed within the recess 62. The first inclined surface 66 of the anchor 44 and the second inclined surface 68 of the proximal neck 38 abut against each other. The distal portion 40 covers the anchor 44 to prevent it from popping out of the recess 62. The tensioning element 42 may be in a tensioned state (or in a released state before the introducer device 20 is moved). In the tensioned state, the tensioning element 42 is tensioned and / or pulled proximally. In the tensioned state, the tensioning element 42 pulls the anchor 44 in the longitudinal direction so that the first inclined surface 66 of the anchor 44 and the second inclined surface 68 of the proximal neck 38 abut against each other. When the tensioning element 42 is in the tensioned state, the implant 22 and the introducer device 20 are substantially immovable relative to each other. In this way, the implant 22 is prevented from being separated from the introducer device 20, and the user can manipulate the introducer device 20, and the implant 22 will move accordingly.

[0038] The actuator 43 is actuated to move the tensioning element 42 from the tensioned state to the released state. The actuator 43 releases the tension on the tensioning element 42 to allow the tensioning element 42 to move relative to the handle 34 and relative to the shaft 30. Figure 5The tensioning element 42 is shown in a released state and the user moves the introducer device 20 away from the implant 22 to remove it from the access cannula 18. The anchor 44 may still be disposed in the recess 62 because the tensioning element 42 may still be allowed to move relative to the handle 34 when the handle 34 is moved proximally.

[0039] As described above, further proximal movement of the introducer device 20 ultimately causes the tensioning element 42 to pull the anchor 44, which is then slidably ejected from the notch 62 for removal with the access cannula 18 with the introducer device 20. In other words, actuation of the tensioning element 42 from the tensioned state to the released state allows the first inclined surface 66 of the anchor 44 and the second inclined surface 68 of the notch 62 to move past each other to facilitate ejection of the anchor 44 from the notch 62. Figure 6 The implant 22 is depicted as being disengaged from the introducer device 20. This functionality is particularly advantageous because the user can manipulate the introducer device 20 with a constraint when the introducer device 20 is disposed through the access cannula 18. In other words, the shaft 30 of the introducer device 20 is disposed to slideably pass through the access cannula 18 so that the user can only withdraw the introducer device 20 in the proximal direction. The anchor 44 and the recess 62 are configured to allow separation only by a proximal force acting on the anchor 44 from the tensioning element 42. The first inclined surface 66 and the second inclined surface 68 effectively convert the axial force into a combined axial-radial force to cause the anchor 44 to move upward within the recess 62 to be ejected.

[0040] In some configurations, the shaft 30 of the introducer device 20 can include a geometry configured to further secure the implant 22 to the introducer device 20 in a tensioned state, namely, an abutment feature 56 and / or an anti-rotation feature 72. The abutment feature 56 can be a surface of a counterbore that extends from the inner surface 58 of the shaft 30 by a third length L3 (see Figure 7 ). The third length L3 can be the same or substantially the same as the first length L1, so that the abutment feature 56 abuts the proximal end 70 of the proximal neck 38 of the implant 22. The anti-rotation feature 72 can be positioned to be radially offset from the recess 62 and include a flat feature 74. A complementary flat feature 75 can be formed in the opening 54 of the shaft 30. When the proximal neck 38 is disposed in the distal portion 40, the flat features 74, 75 engage to prevent the implant 22 from rotating relative to the introducer device 20. As shown, the axial cross-section of the proximal neck 38 of the implant 22 and the opening 54 of the shaft 30 is generally D-shaped. It should be understood that the proximal neck 38 and the distal portion 40 of the introducer device 20 may include additional geometric structures for preventing the implant 22 from rotating relative to the introducer device 20.

[0041] The proximal neck 38 may define an implant lumen 60 that is configured to be coaxially arranged with the shaft lumen 48. In addition, 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 retaining element 32, which includes a hole for guiding bone cement into the vertebral body adjacent to the implant 22. In this way, once the implant 22 has been deployed, the rod 26 can be disengaged from the retaining element 32, and a portion of the introducer device 20 can be removed, after which bone cement can be guided through the shaft lumen 48 and the implant lumen 60. It is noteworthy that the integration of the anchor-based mechanism of the present disclosure can be achieved without redesigning certain components and workflows of bone cement delivery that are familiar to users.

[0042] refer to Figure 8 and Fig. 9 , provides an exemplary configuration of the anchor 44. The anchor 44 includes at least two arcuate surfaces 79 contoured to provide a generally semicircular profile of the proximal neck 38, such that when the anchor 44 is disposed within the recess 62, the inner diameter of the distal portion 40 can be conformed and slidably disposed thereon. Figure 8 The anchor 44 is shown defining a recess 76 that is configured to receive a portion of the tensioning element 42. In other words, the tensioning element 42 can be coupled to the anchor 44 at a location within the recess 76. The tensioning element 42 can be coupled to the anchor 44 in any suitable manner, such as welding, laser welding, adhesive bonding, interference fit, etc. The anchor 44 can also define a slot 77 adjacent to the recess 76 to receive a portion of the tensioning element 42. The slot 77 can extend to the second inclined surface 68. The slot 77 causes the tensioning element 42 to be recessed below the upper surface 81 of the anchor 44, thereby further facilitating the generally semi-circular profile of the proximal neck 38 when the anchor 44 is located within the recess 62. Fig. 9 The embodiment of FIG. 4 shows that the anchor 44 includes a head portion 78 and a tail portion 80 extending from the head portion 78. The head portion 78 includes the second inclined surface 68, and the tail portion 80 can extend from the second inclined surface 68. The tensioning element 42 can be coupled to the tail portion 80.

[0043] Figure 2 The actuator 43 is shown to be of a general form and is provided on the handle 34. Referring now to Figures 10A-11B, shows a more specific exemplary configuration of the actuator 43, wherein the actuator 43 maintains tension on the tensioning element 42 in the tensioned state, and releases the tension on the tensioning element 42 when actuated. As described above, the tensioning element 42 is movable relative to the handle 34 in the released state. For example, the tensioning element 42 may be slidable within the handle 34. Thus, in order to place the tensioning element 42 in the tensioned state, the user may pull the tensioning element 42 proximally within the handle 34. The user may simultaneously actuate the actuator 43 to allow the tensioning element 42 to be pulled proximally. Pulling proximally may be achieved by exposing the proximal end of the tensioning element 42 (i.e., exposed outside the handle), and the user may pinch the proximal end and pull it tight (see Fig.11A and 11B ). Once sufficient resistance is felt due to the engagement between the anchor 44 and the notch 62, the user can release the actuator 43 to maintain the tensioning element 34 in the tensioned state. Alternatively, a tensioning actuator (not shown) or other mechanism can be disposed on the handle 34 and configured to pull the tensioning element 42 proximally within the handle 34 until the resistance is achieved.

[0044] like Figures 10A-10C As shown, the actuator 43 is a button 82. A biasing member 84 can be coupled to the button 82, and actuation of the button 82 is performed against the bias of the biasing member 84. When the button 82 is not actuated, the button 82 is biased to maintain the tensioning element 42 in a tensioned state (or to maintain it in a current state if it is not tensioned). More specifically, the actuator 43 is configured to clamp the tensioning element 42 within the handle 34 to maintain the tensioning element 42 in a tensioned state (see Fig. 10A ). The user can effectively grasp the handle 34 and apply a downward force on the button 82 to actuate the button 82. The actuation of the button 82 releases the tensioning element 42 within the handle 34 to allow the tensioning element 42 to slide relative to the handle 34 (see Fig. 10B ). Although the button 82 is shown as being positioned on the top side of the introducer device 20, it should be understood that the button 82 can be positioned on any side relative to the introducer device 20 and / or at any position relative to the introducer device 20, including any component of the introducer device 20, such as the handle 34. For example, the button 82 can be positioned on the left side of the introducer device 20 so that a user who grasps the handle 34 with his right hand can apply force to the button 82 in a lateral direction with his thumb. Figures 11A-11B The internal components of the handle 34 are shown, wherein the actuator 43 is a lever. The actuator 43 may include a spindle 88 and a biasing member 84 coupled to the spindle 88. The lever is coupled to the spindle 88 and extends outside the handle 34 (not shown). The biasing member 84 may be a torsion spring. The lever 86 may be actuated against the bias of the biasing member 84 by twisting or wrapping the tensioning element 42 around the spindle 88 (see Fig.11A ) to maintain the tensioning element 42 in the tensioned state (or current state). The lever 86 can be actuated by twisting, rotating, pulling, bending, etc. Once the lever 86 is released, the biasing member 84 causes the lever 86 and the spindle 88 to move in the opposite direction to allow the tensioning element 42 to be movable within the handle 34 (see Fig. 11B ). It should be understood that the actuator 43 can be more than one actuator and / or any type of component that can release the tension on the tensioning element, such as but not limited to a sliding switch, a knob, a palm or finger trigger, etc.

[0045] As previously described, the distance that the tensioning element 42 can slide within the handle 34 is greater than the length of the distal portion 40 within which the proximal neck 38 removably extends. The tensioning element 42 can include a stop member 90 at its proximal end for preventing the tensioning element 42 from being disengaged from the handle 34. For example, the stop member 90 can be a blocking member configured to interfere with the internal geometry of the shaft lumen 48 or the handle 34 (see Fig. 10C ). In another example, the stop member 90 can be a retaining ring. In the released state, proximal movement of the introducer device 20 causes the tensioning element 42 to pull the anchor 44, after which the anchor is slidably ejected from the recess 62 to be removed from the access sleeve 18 together with the introducer device 20. The stop member 90 reaching the end point can provide a proximal force to pull the anchor 44 (as opposed to the tensioning element 42 continuing to slide within the handle 34). Once the anchor 44 is separated from the recess 62, the anchor 44 can hang or dangle freely with the tensioning element 42. When the introducer device 20 is removed from the access sleeve 18, the anchor 44 is pulled through the access sleeve 18. Thereafter, the access sleeve 18 remains in the pedicle to provide a working channel, and any other steps of the procedure can be performed through the channel as indicated.

[0046] Other inventive aspects of the present disclosure may be referenced to the following exemplary clauses.

[0047] Item 1 - A method for stabilizing a vertebral body using an implant releasably connected to an introducer device, the introducer device having an actuator, a tensioning element connected to the actuator, and an anchor connected to the tensioning element, wherein the implant includes a proximal neck defining a notch, the method comprising: using an access sleeve to provide a working channel leading to the vertebral body; guiding the implant through the access sleeve with the tensioning element in a tensioned state, wherein the anchor is prevented from separating from the notch by covering the anchor with the distal portion of the shaft; actuating the actuator to move the tensioning element to a released state, in which the tension on the element is released; with the tensioning element in the released state, beginning to withdraw the introducer device from the access sleeve, wherein the proximal neck of the implant is exposed from the distal portion of the shaft to allow the anchor to separate from the notch and the implant to be detached from the introducer device; and withdrawing the introducer device from the access sleeve.

[0048] Clause 2 - The method of clause 1, further comprising delivering bone cement through an implant lumen defined by the proximal neck prior to the step of actuating the actuator.

[0049] Clause 3 - The method of clause 2, further comprising rotating the introducer device to rotate the implant, wherein an anti-rotation feature is disposed on a proximal neck of the implant and within a distal portion of the shaft.

[0050] Clause 4 - The method of any of clauses 1-3, further comprising actuating an actuator while tensioning the tensioning element to move the tensioning element to a tensioned state; and releasing the actuator to maintain the tensioning element in the tensioned state.

[0051] Clause 5 - The method of any of Clauses 1-4, further comprising actuating an implant actuator to expand the implant; disengaging a rod of the introducer device from the implant; and removing the rod through the proximal neck of the implant.

[0052] Several configurations have been discussed in the foregoing description; however, the configurations discussed herein are not exhaustive, the terms used are descriptive rather than restrictive, and many modifications and variations are possible in light of the above disclosure. Specifically, the functionality of the configurations described can and can be used in a variety of other surgical and non-surgical applications where it is desirable to prevent accidental separation of an implant. For example, the systems described herein can be used to deploy implants for plastic surgery, ENT surgery, and the like.

Claims

1. A system for deploying an implant, the system comprising: an introducer device including a handle, an actuator, a shaft extending from the handle, a tensioning element coupled to the actuator and extending along the shaft, and an anchor coupled to the tensioning element; and an implant comprising a proximal neck configured to be removably disposed within a distal portion of a shaft, the proximal neck defining a recess sized to receive an anchor, such that the distal portion of the shaft covers the anchor and prevents separation of the anchor from the recess when the tensioning element is in a tensioned state, Therein, the actuator is configured to be actuated to release tension on the tensioning element to allow the proximal neck to be removed from the distal portion of the shaft and the anchor to be separated from the recess, thereby disengaging the implant from the introducer device.

2. The system according to claim 1, wherein: The anchor further includes a first inclined surface and the proximal neck further includes a second inclined surface configured to engage the first inclined surface when the tensioning element is in a tensioned state.

3. The system according to claim 2, wherein: The first angled surface is oriented at an angle relative to the longitudinal axis of the shaft to allow the anchor to slidably pop out of the notch when the proximal neck is moved proximally relative to the distal portion of the shaft.

4. A system for deploying an implant, the system comprising: Enter the casing; An introducer device comprising a handle, an actuator, a shaft extending from the handle and deployable through an access cannula, a tensioning element coupled to the actuator and extending along the shaft, and an anchor coupled to the tensioning element, wherein the anchor comprises a first angled surface; and An implant comprising a proximal neck configured to be removably disposed within a distal portion of a shaft, the proximal neck comprising a second inclined surface and defining a recess sized to receive an anchor such that the first inclined surface and the second inclined surface abut each other when the tensioning element is in a tensioned state, Wherein, the actuator is configured to be actuated to release tension on the tensioning element to allow the first inclined surface and the second inclined surface to slidably move past each other to assist in ejection of the anchor from the recess and disengagement of the implant from the introducer device.

5. The system according to claim 4, wherein: The anchor also includes a head portion and a tail portion extending from the head portion, the head portion including the first angled surface, wherein the tensioning element is coupled to the tail portion.

6. The system according to any one of claims 1 to 5, wherein: The tensioning element is configured to slide within the handle when the tension is released on the tensioning element.

7. A system for deploying an implant, the system comprising: an introducer device including a handle, an actuator, a shaft extending from the handle and including a distal portion defining a bore, a tensioning element coupled to the actuator and extending along the shaft, and an anchor coupled to the tensioning element; and an implant comprising a proximal neck removably extending within a distal portion of a shaft, the proximal neck defining a recess for engaging the anchor when the tensioning element is in a tensioned state, wherein the actuator is configured to be actuated to release tension on a tensioning element, wherein the tensioning element is slidable within the handle a distance greater than a length of a distal portion within which the proximal neck removably extends, to assist in disengagement of the implant from the introducer device.

8. The system according to claim 6 or 7, wherein: The distal end of the tensioning element is coupled to the anchor, the tensioning element further comprising a proximal end defining a stop member, and wherein the stop member is configured to engage the actuator to prevent the tensioning element from being disengaged from the handle.

9. The system according to any one of claims 1 to 8, wherein: The proximal neck also includes an anti-rotation feature positioned radially offset from the notch.

10. The system according to claim 9, wherein: The proximal neck is generally D-shaped in axial cross-section, with a flat feature that provides the anti-rotation feature.

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

12. The system according to claim 11, wherein: The proximal neck is generally D-shaped in axial cross-section, with a flat feature that provides the anti-rotation feature.

13. The system according to any one of claims 1 to 12, wherein: The shaft of the introducer device defines a channel extending longitudinally along the shaft, and wherein the tensioning element is disposed within the channel.

14. The system according to claim 13, wherein: The channel is defined on an outer surface of the shaft, wherein the shaft is tubular and further defines a shaft lumen, and an aperture extending between the outer surface and the shaft lumen, and wherein the tensioning element passes through the aperture to extend from the shaft lumen at a distal portion of the shaft.

15. The system according to any one of claims 1 to 13, wherein: The handle is cannula-shaped, wherein the shaft is tubular and defines a shaft lumen, wherein the proximal neck is tubular and defines an implant lumen, wherein the cannula-shaped handle, the shaft lumen and the implant lumen are coaxially arranged and configured to receive instruments for deploying the implant within the vertebral body.

16. The system according to any one of claims 1 to 15, wherein: The proximal neck of the implant defines a slot, and wherein the tensioning element is removably disposed within the slot when the anchor is disposed within the recess.

17. The system according to any one of claims 1 to 16, wherein: The anchor defines a recess configured to receive a portion of a tensioning element.

18. The system according to any one of claims 1 to 17, wherein: The actuator is a button and further includes a biasing member coupled to the button, wherein actuating the button against the bias of the biasing member is configured to clamp the tensioning element within the handle to retain the tensioning element in a tensioned state.

19. The system according to any one of claims 1 to 17, wherein: The actuator is a lever and further includes a spindle, and a biasing member coupled to the lever, wherein actuating the lever against a bias of the biasing member is configured to twist the tensioning element about the spindle to maintain the tensioning element in a tensioned state.

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

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