Self-tapping type distractable system for centrum

Abstract

The self-tapping type distracting system comprises a vertebral body implant and an implanting tool, and the vertebral body implant is sequentially provided with a self-tapping structure and a distracting unit capable of being distracted in the radial direction from the far end to the near end in the axial direction of the vertebral body implant; the implanting tool is detachably connected with the near end of the vertebral body implant, the implanting tool is used for applying rotating force to the vertebral body implant so as to drive the vertebral body implant to rotate synchronously and to be tapped into the vertebral body through the self-tapping structure, and the implanting tool is further used for driving the opening unit to open after the vertebral body implant moves to a preset position in the vertebral body. By the adoption of the scheme, after the implanting tool drives the self-tapping unit to tap into the preset position, the same implanting tool continues to drive the opening unit to conduct opening, the purpose that the vertebral body implant is installed at the preset position in the vertebral body is achieved without replacing the tool, and finally the vertebral body implant can be installed at the preset position in the vertebral body through the detachable connecting structure between the implanting tool and the vertebral body implant. The implanting tool can be conveniently detached, the operation efficiency is high, and the operation complexity is effectively reduced.

Description

Technical Field

[0001] This invention relates to the field of vertebral body expansion devices, and in particular to a self-tapping expandable system for vertebral bodies. Background Technology

[0002] For expandable vertebral body implants, the vertebroplasty kit is an indispensable set of disposable consumables used during the vertebroplasty procedure. This kit typically includes core components such as a puncture system and an expansion system. The expansion system mainly consists of a high-precision drill, guide needle, expansion cannula, and working cannula, and is used to establish and maintain a surgical channel from the body surface to the vertebral body, assisting in key steps such as vertebral body preparation and implant placement.

[0003] It is known that when the existing expandable implantable tool is inserted into the vertebral body, it is necessary to first use a hole-opening tool kit to create a groove in the bottom hole, and then use an auxiliary component to insert the implantable tool and complete the expansion of the implantable tool, which leads to a complicated surgical procedure. Summary of the Invention

[0004] Based on this, a self-tapping expandable system for the vertebral body is provided to solve the problem that the existing expandable device requires the use of multiple tools to insert into the vertebral body, resulting in complicated surgical procedures.

[0005] On one hand, the present invention provides a self-tapping expandable system for a vertebra, the self-tapping expandable system comprising: The vertebral implant has a self-tapping structure and a radially expandable expansion unit arranged sequentially from the distal end to the proximal end along its axial direction; The implantation tool is detachably connected to the proximal end of the vertebral body implant. It is used to apply rotational force to the vertebral body implant to drive the vertebral body implant to rotate synchronously and penetrate the vertebral body through a self-tapping structure. It is also used to drive the opening unit to open after the vertebral body implant has moved to a predetermined position in the vertebral body.

[0006] In one implementation, the expanding unit includes: The main body, whose axial distal end is connected to a self-tapping structure; Two expandable bodies are radially slidably connected to the main body, and the two expandable bodies have a closed state and an expanded state; When closed, the outer contours of the main body and the two open bodies together form a cylindrical surface; In the extended state, the two extended bodies move radially outward a set distance relative to the main body.

[0007] In one implementation, the expanding unit also includes: The slide groove and the slider are respectively set on the main body and on each supporting body, and the slider is movably set in the slide groove; The slide includes a first slide, the extension direction of the first slide makes an acute angle with the axial direction of the supporting unit; when the slider moves along the first slide, it drives the supporting body to move synchronously in the axial and radial directions.

[0008] In one implementation, the main body includes a mounting groove extending radially therethrough for accommodating two support bodies; the mounting groove has two opposing inner walls parallel to the axis of the main body, each inner wall having two first sliding grooves at the proximal end and two first sliding grooves at the distal end, and each support body having four sliders. Each expander is movably engaged with four first grooves via its four sliders; wherein two sliders engage with a proximal first groove and a distal first groove on one inner wall, and the other two sliders engage with a proximal first groove and a distal first groove on another inner wall. The chute also includes: The second groove has its proximal end connected to the distal end of the first groove located at the proximal end, and extends in a direction parallel to the axial direction. The third groove has its proximal end connected to the distal end of the first groove located at the distal end, and extends along a length direction parallel to the first groove.

[0009] In one implementation, the expanding unit also includes: The bone cement outlet hole is opened through the outer peripheral wall of the support body; The bone cement discharge opening, when the support body is in the supported state, forms an open gap between the proximal and / or distal ends of the support body and the outer surface of the main body, and the gap constitutes the bone cement discharge opening. The bone cement inlet channel is located and connected to the axial center of the vertebral implant and the implantation tool, and is connected to the bone cement outlet hole and the bone cement outlet opening, respectively.

[0010] In one implementation, the vertebral implant also includes a pusher and a threaded sleeve that are threadedly connected from distal to proximal. At least a portion of the pusher extends axially between two expanders. The pusher is provided with a protruding locking block, and the expanders are provided with strip-shaped locking grooves that mate with the locking blocks. The locking blocks are received in the locking grooves, allowing the expanders to move radially relative to the pusher, while the two cannot rotate relative to each other. Implantation tools include: The inner rod, the distal end of which is detachably connected axially to the proximal end of the threaded sleeve in a manner that can transmit torque; The outer tube is rotatably fitted over the inner rod, and its distal end is detachably threaded to the proximal end of the vertebral implant, with a first tooth provided at its proximal end; The connector and the inner rod form a mating structure that allows for axial relative movement and synchronous rotation through a keyway structure, and a second tooth is provided at its distal end; in, When the first tooth and the second tooth are in a meshing state, the inner rod, the outer tube, and the connecting parts rotate synchronously. When the first tooth and the second tooth are separated, the inner rod can move and rotate axially relative to the outer tube.

[0011] In one implementation, the vertebral implant also includes: The fastening unit is connected to the proximal end of the spreading unit, and its outer periphery is provided with external threads; The connecting unit is connected to the proximal end of the fastening unit and is detachably threaded to the outer tube.

[0012] In one implementation, the connecting unit has a U-shaped structure, with one bottom end of the U-shape connected to the fastening unit. The connecting unit includes: Two support arms are formed on the two side walls of the U-shape, and are provided with internal threads and connected to the external thread structure of the outer tube; The weak groove is located on both arms near the bottom of the U-shape, and its radial cross-sectional area is smaller than that of other parts of the arms. A connecting hole is radially through the bottom of the U-shape.

[0013] In one implementation, the self-attacking structure includes: The self-tapping unit has its proximal end connected to the distal end of the spreading unit, and its radial outer periphery is surrounded by self-tapping threads. The positioning unit has a distal end that is a pointed tip for positioning when it is inserted into the vertebral body, and its proximal end is connected to the distal end of the self-tapping unit.

[0014] In one implementation, the self-tapping expandable system also includes: The locator, detachably connected to the implantation tool, is used to position the vertebral implant for placement in the vertebral body.

[0015] In one implementation, the expander is expandably disposed in the mounting groove. The expander includes a first wall and two second walls, and the first wall and / or the second wall are provided with bone cement discharge holes. When closed, the expander is housed within the mounting slot; In the extended state, at least a portion of the extendable body protrudes from the mounting groove and forms a U-shaped structure. The first wall serves as the bottom of the U-shaped structure, and the second wall serves as the side wall of the U-shaped structure, together forming the U-shaped structure. The first wall, the two second walls, and the inner wall of the mounting groove together form a bone cement channel, which has a first opening facing the distal end. Both the bone cement discharge hole and the bone cement channel are connected to the bone cement inlet channel.

[0016] In one implementation, there are two supporting bodies, which are arranged radially symmetrically within the mounting groove.

[0017] In one implementation, in the extended state, the first wall extends fully out of the mounting groove, at least a portion of the second wall extends out of the mounting groove, and the bone cement channel also forms a second opening facing the proximal end.

[0018] In one implementation, the extended state includes a parallel extended state in which the extended body extends parallel to the mounting groove, and an inclined extended state in which the extended body extends obliquely to the mounting groove. In the parallel open state, the opening area of ​​the first opening is equal to the opening area of ​​the second opening; When tilted and open, the opening area of ​​the first opening is larger than the opening area of ​​the second opening.

[0019] In one implementation, the positioning unit is cone-shaped, with the distal end being the small end of the cone and the proximal end being the large end of the cone.

[0020] In one implementation, there are two blocks, which are arranged radially symmetrically on both sides of the pusher; the slot is opened on the second wall.

[0021] In one implementation, the self-attacking unit includes: The cutting section, which is frustoconical in shape and has multi-threaded outer periphery, is configured to cut bone tissue to form a bottom hole during vertebral implantation. The small, truncated cone-shaped end of the cutting part is located at the far end of the cutting part and connected to the near end of the positioning unit, while the large, truncated cone-shaped end of the cutting part is located at the near end of the cutting part.

[0022] In one implementation, the multi-start thread consists of multiple cutting teeth spaced apart along the circumferential direction, with chip removal grooves formed between adjacent cutting teeth, and the tooth crests of the cutting teeth being constructed as cutting edges.

[0023] In one implementation, five cutting teeth are evenly spaced on the outer periphery of the cutting section.

[0024] In one implementation, the self-attacking unit also includes: The thread forming part has its distal end connected to the proximal end of the cutting part. Its outer diameter is larger than the outer diameter of the large end of the frustum-shaped cutting part. Its outer periphery is provided with a first mechanical thread, which is configured to tap a first internal thread on the inner wall of the bottom hole.

[0025] In one implementation, the thread forming part is frustoconical, and the small end of the frustoconical part is connected to the cutting part.

[0026] In one implementation, the vertebral body dispersing device includes: The expansion unit can be radially expanded. Its outer diameter is smaller than the outer diameter of the large end of the frustum-shaped threaded part, and its far end is connected to the near end of the threaded part. The fastening unit has its distal end connected to the proximal end of the spreading unit, and its outer periphery is provided with a second mechanical thread; A connecting unit, the distal end of which is connected to the proximal end of a fastening unit; Wherein, the outer diameter of the second mechanical thread is not greater than the outer diameter of the large end of the frustum-shaped threaded portion; when the vertebral implant is inserted into the vertebral body, the second mechanical thread mates with the first internal thread; or The outer diameter of the second mechanical thread is larger than the outer diameter of the large end of the frustum-shaped thread forming part. When the vertebral implant is inserted into the vertebral body, the second mechanical thread taps out a second internal thread that mates with the second mechanical thread based on the first internal thread.

[0027] In one implementation, the outer diameter of the second mechanical thread is greater than the outer diameter of the large end of the frustum-shaped thread forming part, and the axial length of the second mechanical thread is greater than the axial length of the first mechanical thread.

[0028] In one implementation, the positioning unit is cone-shaped, with the distal end being the small end of the cone and the proximal end being the large end of the cone.

[0029] In one implementation, a transition unit is provided between the self-tapping unit and the positioning unit. The transition unit is also frustum-shaped. The small end of the frustum-shaped self-tapping unit is connected to the large end of the frustum-shaped transition unit, and the small end of the frustum-shaped transition unit is connected to the large end of the cone-shaped positioning unit.

[0030] The beneficial effects of this invention are as follows: This solution features a vertebral implant with a self-tapping structure, which taps the vertebral body without requiring additional tools for bottom-drilling. Furthermore, this solution uses an implantation tool in conjunction with the vertebral implant. After the implantation tool drives the self-tapping unit to the predetermined position, the same implantation tool continues to drive the expansion unit to expand it, eliminating the need to change tools and thus achieving the installation of the vertebral implant into the predetermined position within the vertebral body. Finally, the detachable connection structure between the implantation tool and the vertebral implant allows for easy removal of the implantation tool, completing the entire implantation process. In summary, this solution uses only an implantation tool to assist the vertebral implant in completing the self-tapping drilling and insertion of the vertebral implant into the vertebral body, as well as the expansion within the vertebral body, without requiring other tools. This results in high operational efficiency and effectively reduces surgical complexity. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of a self-tapping, expandable system for a vertebra in one embodiment. Figure 2 This is a schematic diagram of a self-tapping, expandable system for a vertebra in another embodiment; Figure 3 for Figure 2 Schematic diagram of the cross-sectional structure at point AA; Figure 4 for Figure 3 Enlarged structural diagram at point B; Figure 5 for Figure 3 Enlarged structural diagram at point C; Figure 6 for Figure 1 Enlarged structural diagram at point D; Figure 7 This is a schematic diagram of the structure of the expansion unit of the vertebral implant in the closed state in one embodiment; Figure 8 for Figure 7 Schematic diagram of the cross-sectional structure at the middle EE; Figure 9 for Figure 8 Enlarged structural diagram at point F; Figure 10 In the partially expanded state of the expansion unit and with Figure 9 A schematic diagram of the structure cut along the same location; Figure 11 In the fully expanded state of the expansion unit and with Figure 9 A schematic diagram of the structure cut along the same location; Figure 12 A schematic diagram of a partial structure of a vertebral implant; Figure 13 for Figure 12 Schematic diagram of the cross-sectional structure at the middle GG point; Figure 14 This is a partial structural diagram of the interior of the support unit in one embodiment; Figure 15 This is a schematic diagram of a partial structure inside the expander unit in another embodiment.

[0032] In the attached diagram, the components represented by each number are as follows: 1. Vertebral implant; 11. Positioning unit; 12. Self-tapping unit; 121. Cutting section; 1211. Cutting tooth; 1212. Chip groove; 1213. Cutting edge; 122. Thread forming part; 1221. First mechanical thread; 13. Expand the unit; 131. Main body; 1311. Mounting slot; 1312. Inner wall; 1313. Inner layer; 1314. Outer layer; 132. Support body; 1321. Slot; 1322. First wall; 1323. Second wall; 133, Slide groove; 1331, First slide groove; 1332, Second slide groove; 1333, Third slide groove; 134. Slider; 135. Bone cement discharge hole; 136. Bone cement discharge opening; 1361. First opening; 1362. Second opening; 137. Bone cement inlet channel; 14. Pushing component; 141. Locking block; 15. Threaded sleeve; 16. Fastening unit; 161. Second mechanical thread; 17. Connecting unit; 171. Support arm; 172. Weak groove; 173. Connecting hole; 18. Transition unit; 2. Implantation tool; 21. Inner rod; 22. Outer tube; 221. First tooth; 23. Connector; 231. Second tooth; 24. Handle; 3. Positioner. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of this application and are not intended to limit its scope. It should be noted that the illustrations provided in this embodiment are only schematic representations of the basic concept of the invention. Therefore, the drawings only show components relevant to the invention and are not drawn according to the actual number, shape, and size of the components. In actual implementation, the form, quantity, and proportion of each component can be arbitrarily changed, and the component layout may be more complex. The structures, proportions, sizes, etc., depicted in the accompanying drawings are only used to complement the content disclosed in the specification for those skilled in the art to understand and read, and are not intended to limit the conditions under which the invention can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to the size, without affecting the effects and objectives achieved by the invention, should still fall within the scope of the technical content disclosed in this invention.

[0034] A self-tapping, expandable system for the vertebral body, see [link / reference]. Figure 1 and Figure 2The self-tapping expandable system includes a vertebral implant 1 and an implantation tool 2. The vertebral implant 1 is provided with a self-tapping structure and a radially expandable expansion unit 13 along its axial direction from the distal end to the proximal end. The implantation tool 2 is detachably connected to the proximal end of the vertebral implant 1. The implantation tool 2 is used to apply a rotational force to the vertebral implant 1 to drive the vertebral implant 1 to rotate synchronously and penetrate the vertebral body through the self-tapping structure. The implantation tool 2 is also used to drive the expansion unit 13 to expand after the vertebral implant 1 moves to a predetermined position in the vertebral body.

[0035] This solution utilizes a vertebral implant 1 with a self-tapping structure to drill holes in the vertebral body, eliminating the need for additional bottom-drilling tools. Furthermore, the implantation tool 2 works in conjunction with the vertebral implant 1. After the self-tapping unit 12 is driven into the predetermined position by the implantation tool 2, the same tool 2 continues to drive the expansion unit 13 to expand the vertebral body. This eliminates the need to change tools, thus successfully placing the vertebral implant 1 into the predetermined position within the vertebral body. Finally, the detachable connection between the implantation tool 2 and the vertebral implant 1 allows for easy removal of the implantation tool 2, completing the entire implantation process. In summary, this solution uses only the implantation tool 2 to assist the vertebral implant 1 in drilling and inserting the implant into the vertebral body, as well as completing the expansion within the vertebral body. No other tools are required, resulting in high operational efficiency and effectively reducing surgical complexity.

[0036] In some embodiments, see Figure 7 and Figure 8 The spreading unit 13 includes a main body 131 and two spreading bodies 132. The distal end of the main body 131 is connected to a self-tapping structure along its axial direction. The two spreading bodies 132 are radially slidably connected to the main body 131 and have a closed state and an open state. In the closed state, the outer contours of the main body 131 and the two spreading bodies 132 together form a cylindrical surface. In the open state, the two spreading bodies 132 move radially outward a set distance relative to the main body 131. Thus, in the closed state, the outer wall of the spreading device is an easily penetrated cylindrical surface, facilitating insertion into the cone body.

[0037] In the embodiments, the expandable structure can be any specific structure that can achieve linear guidance function, such as "guide rail and slide 133", "guide post and guide hole", "cam and follower".

[0038] Figure 9 This is a schematic diagram of the open unit 13 in the closed state, with all the corresponding sliders 134 located within the first groove 1331; Figure 10 This is a schematic diagram of the expansion unit 13 in a partially expanded state, with all the corresponding sliders 134 located in the first groove 1331. After the expansion unit 13 is expanded, it is parallel to the axial direction. Figure 11 The diagram shows the expansion unit 13 in its fully expanded state. The four sliders 134 in the diagram are divided into two located at the near end and two located at the far end. The two sliders 134 located at the near end are both located in the second slide groove 1332, and the two sliders 134 located at the far end are both located in the third slide groove 1333.

[0039] In some embodiments, see Figure 8 and Figure 9 The expansion unit 13 also includes a slide groove 133 and a slider 134. One of the slide groove 133 and the slider 134 is disposed on the main body 131 and the other is disposed on each expansion body 132. The slider 134 is movably disposed in the slide groove 133. The slide groove 133 includes a first slide groove 1331. The extension direction of the first slide groove 1331 forms an acute angle with the axial direction of the expansion unit 13. When the slider 134 moves along the first slide groove 1331, it drives the expansion body 132 to move synchronously in the axial and radial directions. Thus, it is determined that the angle between the first slide groove 1331 and the axial direction is an acute angle, so that when the slider 134 moves along the first slide groove 1331, it drives the opening unit 13 to move synchronously in the axial and radial directions to complete the opening of the opening body 132. Specifically, there are two ways to set the slide groove 133 and the slider 134. The first is that the slide groove 133 is set on the main body 131 and the slider 134 is set on the opening body 132. The second is that the slide groove 133 is set on the opening body 132 and the slider 134 is set on the main body 131. The two methods are selected according to the specific structural settings and requirements.

[0040] In some embodiments, see Figure 9 and Figure 11 The main body 131 includes a radially extending mounting groove 1311 for accommodating two expanders 132. The mounting groove 1311 has two opposing inner walls 1312 parallel to the axis of the main body 131. Each inner wall 1312 has two proximal first sliding grooves 1331 and two distal first sliding grooves 1331. Each expander 132 is provided with four sliders 134. Each expander 132 is movably engaged with four first sliding grooves 1331 via its four sliders 134. Two sliders 134 engage with a proximal first sliding groove 1331 and a distal first sliding groove 1331 on one inner wall 1312, and the other two sliders 134 engage with a proximal first sliding groove 1331 and a distal first sliding groove 1331 on the other inner wall 1312. Thus, the structure of the three types of sliding grooves 133 and sliders 134 cooperating between the supporting unit 13 and the main body 131 is clarified; the second sliding groove 1332 is set at the near end and the third sliding groove 1333 is set at the far end, so that the sliding groove 133 can move continuously at the far end and the near end, so as to achieve the effect of tilting and supporting the supporting body 132.

[0041] See Figure 9 and Figure 11 The slide 133 further includes a second slide 1332 and a third slide 1333. The proximal end of the second slide 1332 is connected to the distal end of the first slide 1331 located at the proximal end, and the second slide 1332 extends in a direction parallel to the axial direction. The proximal end of the third slide 1333 is connected to the distal end of the first slide 1331 located at the distal end, and the third slide 1333 extends in a length direction parallel to the first slide 1331. In the parallel open state, the sliders 134 are all disposed in the first slide 1331. In the inclined open state, the distance between the distal end of the third slide 1333 and the axis is greater than the distance between the second slide 1332 and the axis. The sliders 134 located at the proximal end of the second wall 1323 are disposed in the second slide 1332, and the sliders 134 located at the distal end of the first wall 1322 are disposed in the third slide 1333. This leads to three types of slide groove 133 structures, clarifying the extension direction and interconnection of the three types of slide groove 133; the slider 134 slides within the three types of slide groove 133, and the slider 134 moves to different slide groove 133 to switch between parallel opening and inclined opening states.

[0042] See Figure 10 and Figure 11 The slide groove 133 is disposed on the inner wall of the mounting groove 1311. Each second wall 1323 has a slider 134 disposed at its proximal and distal ends respectively. The first slide groove 1331 has multiple slide grooves and is disposed at the proximal and distal ends corresponding to the two sliders 134 on the second wall 1323 respectively. The angle between the extension direction of the first slide groove 1331 and the axial direction is an acute angle. Each second wall 1323 is engaged with the corresponding two first slide grooves 1331 through two sliders 134.

[0043] In the embodiments, see Figure 14 Each second wall 1323 is provided with a proximal slider 134 and a distal slider 134; the inner wall of the main body 131 is provided with a proximal groove 133 and a distal groove 133; see Figure 10The proximal slide 133 includes a first slide 1331 and a second slide 1332 connected together. The proximal end of the second slide 1332 communicates with the distal end of the first slide 1331 located at the proximal end. The extension direction of the first slide 1331 forms an acute angle with the axial direction, and the second slide 1332 extends in a direction parallel to the axial direction. The distal slide 133 includes a second slide 1332 and a third slide 1333 connected together. The proximal end of the third slide 1333 communicates with the distal end of the first slide 1331 located at the distal end. The extension direction of the first slide 1331 forms an acute angle with the axial direction, and the third slide 1333 extends in a length direction parallel to the first slide 1331. The proximal slider 134 slides within the proximal slide 133, and the distal slider 134 slides within the distal slide 133. Figure 8 Each main body 131 has two proximal sliding grooves 133 and two distal sliding grooves 133 on one side of its inner wall, which correspond to and match the sliders 134 on the two second walls 1323 of the two supporting bodies 132 on that side. The two proximal sliding grooves 133 are partially connected, and the two distal sliding grooves 133 are also partially connected. The direction of the sliders 134 in the sliding grooves 133 can be referred to Figures 9 to 11 .

[0044] In the embodiments, see Figure 14 and Figure 15 The slider 134 is disposed on the second wall 1323. The sliders 134 disposed on the same side of different supporting bodies 132 are staggered and are provided on the corresponding second wall 1323, so that the sliders 134 on the second wall 1323 of the two supporting bodies 132 can be engaged with the slide groove 133 on the main body 131.

[0045] In some embodiments, see Figure 3 , Figure 4 and Figure 11The expansion unit 13 also includes a bone cement discharge hole 135, a bone cement discharge opening 136, and a bone cement inlet channel 137; the bone cement discharge hole 135 is formed through the outer peripheral wall of the expansion body 132; when the expansion body 132 is in the expanded state, an open gap is formed between the proximal end and / or distal end of the expansion body 132 and the outer surface of the main body 131, and the gap constitutes the bone cement discharge opening 136; the bone cement inlet channel 137 is located in the axial middle of the vertebral implant 1 and the implantation tool 2 and is connected to them, and the bone cement inlet channel 137 is connected to the bone cement discharge hole 135 and the bone cement discharge opening 136 respectively. In this way, when the body is open, the bone cement can be discharged along the bone cement outlet 136 formed by the proximal, distal, or proximal and distal ends of the expander 132, so that the bone cement can fill the proximal, distal, or proximal and distal ends of the expander 132 when discharged. In addition, the bone cement can also be discharged along the bone cement outlet hole 135, so that the bone cement can be discharged along the circumference of the expander 132. The combination of these two methods improves the dispersion and uniformity of the bone cement during filling, so as to ensure the amount of bone cement filling at the distal end, improve the mechanical support effect after the bone cement has hardened, enhance the postoperative vertebral body strengthening effect, and reduce the risk of re-fracture after surgery.

[0046] In some embodiments, see Figure 4 The vertebral implant 1 also includes a pusher 14 and a threaded sleeve 15 threadedly connected distally to proximally, at least a portion of the pusher 14 extending axially between the two expanders 132, see [link to relevant documentation]. Figure 14 and Figure 15 The pushing member 14 is provided with a protruding locking block 141, and the expanding body 132 is provided with a strip-shaped locking groove 1321 that mates with the locking block 141. The locking block 141 is accommodated within the locking groove 1321, allowing the expanding body 132 to move radially relative to the pushing member 14 when it moves axially with the pushing member 14. A threaded sleeve 15 is threadedly connected to the proximal end of the pushing member 14. The pushing member 14 is configured to move axially when the threaded sleeve 15 rotates, thereby pushing the expanding body 132 to move distally while simultaneously expanding radially. See also... Figure 3 and Figure 5 The implantation tool 2 includes an inner rod 21, an outer tube 22, and a connector 23. The distal end of the inner rod 21 is detachably connected axially to the proximal end of the threaded sleeve 15 in a torque-transmitting manner. The outer tube 22 is rotatably fitted over the inner rod 21, and its distal end is detachably threadedly connected to the proximal end of the vertebral implant 1. The proximal end of the outer tube 22 has a first tooth 221. The connector 23 and the inner rod 21 form a mating structure that allows axial relative movement and synchronous rotation through a keyway structure. The distal end of the connector 23 has a second tooth 231. (See also...) Figure 5When the first tooth 221 and the second tooth 231 are engaged, the inner rod 21, the outer tube 22, and the connecting member 23 rotate synchronously. When the first tooth 221 and the second tooth 231 are disengaged, the inner rod 21 can move and rotate axially relative to the outer tube 22. Thus, the pusher 14 pushes the slider 134 to move within the groove 133, so that when the threaded sleeve 15 rotates, it drives the pusher 14 to move axially, thereby pushing the supporting body 132 to move. Through the cooperation structure of the groove 133 of the supporting body 132 and the slider 134, the supporting body 132 moves simultaneously in both the radial and axial directions.

[0047] For details, see Figure 14 and Figure 15 The pusher 14 pushes the slider 134 to move within the groove 133, so that when the threaded sleeve 15 rotates, the pusher 14 moves axially, thereby pushing the expansion body 132 to move. Through the cooperation structure of the groove 133 and the slider 134 of the expansion body 132, the expansion body 132 moves simultaneously radially and axially. The corresponding movement method is that when the threaded sleeve 15 is rotated under force, the main body 131 must be restricted from rotating. Since the pusher 14 is threadedly connected to the threaded sleeve 15 but the pusher 14 cannot rotate (the pusher 14 cannot rotate, which is essentially due to the main body 131 not being able to rotate, and the main body 131 not being able to rotate, which makes the expansion body 132 not being able to rotate, and the expansion body 132 and the pusher 14 cannot rotate relative to each other), the pusher 14 will move axially, that is, the pusher 14 will move towards the far end to drive the locking block 141 to move within the locking groove 1321, thereby driving the expansion body 132 to move towards the far end while simultaneously expanding radially.

[0048] Specifically, the length of the slot 1321 is arranged radially.

[0049] In some embodiments, see Figure 14 and Figure 15 There are two locking blocks 141, which are symmetrically arranged radially on both sides of the pusher 14; the slots 1321 are formed on the second wall 1323. In this way, the number of locking blocks 141 is the same as the number of expanding bodies 132. The two locking blocks 141 are used to maintain a locking state with the slots 1321 of the two expanding bodies 132, so as to push the expanding bodies 132 to open and make the expanding bodies 132 and the pusher 14 form a structure of synchronous rotation.

[0050] For details, see Figure 14 and Figure 15The locking block 141 can be in the form of a cross structure. The cross structure has two first protrusions arranged along a first direction and extending in opposite directions, and two second protrusions arranged along a second direction and extending in opposite directions. The first protrusions and the second protrusions are arranged in mutually perpendicular directions. The two first protrusions are respectively locked into the corresponding slots 1321 of the second wall 1323, and the two second protrusions are arranged between the two second walls 1323 to improve the structural stability of the entire locking block 141.

[0051] Specifically, the locking block 141 of the pusher 14 is located at the axial center of the support body 132, and is engaged with the support body 132 through the locking block 141, so as to form a structure in which the pusher 14 and the support body 132 cannot rotate relative to each other.

[0052] In some embodiments, see Figure 2 and Figure 7 The vertebral implant 1 also includes a fastening unit 16 and a connecting unit 17. The fastening unit 16 is connected to the proximal end of the spreading unit 13, and the outer periphery of the fastening unit 16 is provided with external threads. The connecting unit 17 is connected to the proximal end of the fastening unit 16, and the connecting unit 17 is detachably threadedly connected to the outer tube 22. Thus, When the implantation tool 2 drives the vertebral implant 1 to rotate and penetrate into the vertebral body, the first tooth 221 and the second tooth 231 mesh, and the inner rod 21, the outer tube 22 and the connector 23 rotate synchronously to drive the vertebral implant 1 and the implantation tool 2 to rotate synchronously. When the implantation tool 2 drives the vertebral implant 1 to open, the first tooth 221 separates from the second tooth 231, and the inner rod 21 can move and rotate axially relative to the outer tube 22. The distal end of the inner rod 21 is detachably connected axially to the proximal end of the threaded sleeve 15 in a torque-transmitting manner. The pusher 14 and the threaded sleeve 15 are threadedly connected. The outer tube 22 is restricted from rotating, so that the connecting unit 17 connected to the outer tube 22 does not rotate, so that the main body 131 of the opening unit 13 does not rotate, thereby preventing the opening body 132 from rotating. The opening body 132 can move radially relative to the pusher 14, but the two cannot rotate relative to each other, that is, the pusher 14 can only move axially. Thus, when the inner rod 21 rotates relative to the outer tube 22, it drives the pusher 14 to move linearly, so that the opening body 132 is opened radially.

[0053] In the embodiments, see Figure 2 The proximal end of the inner rod 21 is connected to a detachable handle 24.

[0054] In this embodiment, the main body 131 is divided into inner and outer layer structures, see [link / reference]. Figure 12-13 This corresponds to the inner structure of the main body 131.

[0055] In some embodiments, see Figure 7 and Figure 8The connecting unit 17 has a U-shaped structure, with one bottom end of the U-shape connected to the fastening unit 16. The connecting unit 17 includes two support arms 171, a weak groove 172, and a connecting hole 173. The two support arms 171 are formed on the two side walls of the U-shape, and are provided with internal threads that connect to the external thread structure of the outer tube 22. The weak groove 172 is located on the two support arms 171 near the bottom of the U-shape, and the radial cross-sectional area of ​​the weak groove 172 is smaller than that of other parts of the support arms 171. The connecting hole 173 is radially through the bottom of the U-shape. In this way, the specific structure of the second connecting part is revealed, and the support arms 171 of the connecting unit 17 are provided so that the support arms 171 are used to connect the implantation tool 2 during implantation, facilitating the threaded connection between the implantation tool 2 and the vertebral implant 1. After the auxiliary implantation tool 2 is inserted into the vertebral body, the support arms 171 can be broken off to remove the excessively long support arms 171.

[0056] Bone tissue consists of an outer cortical bone and an inner cancellous bone. The cortical bone is hard and forms the outer shell of the bone, while the cancellous bone is spongy and located inside the bone. The vertebral body, as the main weight-bearing part of the vertebra, is filled with cancellous bone and is covered by a thin layer of cortical bone.

[0057] In some embodiments, see Figure 6 The self-tapping structure includes a self-tapping unit 12 and a positioning unit 11. The proximal end of the self-tapping unit 12 is connected to the distal end of the spreading unit 13, and the radial outer periphery of the self-tapping unit 12 is surrounded by self-tapping threads. The distal end of the positioning unit 11 is a pointed tip used for positioning when it is inserted into the vertebral body. The proximal end of the positioning unit 11 is connected to the distal end of the self-tapping unit 12, and the distal end of the positioning unit 11 is a pointed tip. In this way, the positioning unit 11 is inserted into the vertebral body for positioning, and then the self-tapping unit 12 with self-tapping threads is rotated to penetrate. This facilitates the insertion of the positioning unit 11 into the cortical bone of the outer layer of the vertebral body and positions the vertebral implant 1 on the cortical bone, so as to facilitate the positioning of the self-tapping unit 12 when it penetrates the vertebral body, and allows the self-tapping unit 12 to penetrate the vertebral body in a fixed direction, thereby avoiding slippage of the self-tapping unit 12.

[0058] Specifically, the tip of the positioning unit 11 includes, but is not limited to, a regular circular sharp structure, as well as the small end of a hollow frustum, with the small end of the frustum being a ring-shaped sharp structure; in addition, other sharp structures that can stably penetrate the cortical bone and rotate synchronously with the self-tapping unit without shifting their axial position should all be included in the interpretation of the tip of this solution.

[0059] Correspondingly, the outer periphery of the vertebra is lined with hard cortical bone, see [link to relevant documentation]. Figure 2The vertebral implant 1 in this design has a distal end and a proximal end. A self-tapping unit 12 and a positioning unit 11 are provided at the distal end of the vertebral implant 1. When the vertebral implant 1 is placed into the vertebral body, the positioning unit 11 positions it on the cortical bone of the outer layer of the vertebral body to avoid slippage when the self-tapping unit 12 is used for drilling. Therefore, by setting the positioning unit 11 and the self-tapping unit 12 at the distal end of the vertebral implant 1, this design allows for direct positioning followed by drilling. The positioning unit 11 is used to first position the implant on the cortical bone of the vertebral body, and then the self-tapping unit 12 is used to drill a hole in the vertebral body. This prevents the self-tapping unit 12 from slipping on the cortical bone during drilling. This design eliminates the need for a dedicated drilling tool to create a hole in the cortical bone of the vertebral body, as is required in existing technologies, before implanting the implant into the vertebral body using a self-tapping device. This reduces the number of instruments and procedures required for the surgery, lowers the complexity of the procedure, and shortens the surgical time.

[0060] In some embodiments, see Figure 1 The self-tapping, expandable system also includes a locator 3, which is detachably connected to the implantation tool 2. The locator 3 is used to position the vertebral implant 1 within the vertebral body. In this way, the locator 3 positions the implant within the vertebral body so that the operator can monitor the position of the implant in real time.

[0061] In some embodiments, see Figure 14 and Figure 15 The expander 132 includes a first wall 1322 and two second walls 1323, with bone cement discharge holes 135 provided on the first wall 1322 and / or the second wall 1323. In the closed state, the expander 132 is received within the mounting groove 1311. In the expanded state, at least a portion of the expander 132 extends out of the mounting groove 1311 and forms a U-shaped structure, wherein the first wall 1322 is the bottom of the U-shaped structure, and the second walls 1323 are the side walls of the U-shaped structure. Two opposing second walls 1323 are provided on opposite sides, together forming the U-shaped structure. At least a portion of the first wall 1322 and at least a portion of the two second walls 1323 extend out of the mounting groove, and the extended portion of the first wall 1322 is further away from the main body 131, so that the first wall 1322, the two second walls 1323, and the inner wall of the mounting groove 1311 together form a bone cement channel, and the bone cement channel forms a first opening 1361 with an opening facing the distal end. See also Figure 4Both the bone cement outlet 135 and the bone cement channel are connected to the bone cement inlet channel 137. Thus, in the expanded state, a first opening 1361 facing the distal end is formed on the expanding device, which, together with the radially arranged bone cement outlet 135, allows bone cement to simultaneously fill the distal end and radial direction of the expanding device, improving the dispersion and uniformity of the bone cement during filling. Specifically, the expanding body 132 has a U-shaped structure in the expanded state. Regarding the actual shape of the expanding body 132: the expanding body 132 can be a single unit with a U-shaped structure; the expanding body 132 can also include a separate first wall 1322 and two second walls 1323, which move under the drive of the driving mechanism and form a U-shaped structure in the expanded state.

[0062] For details, see Figure 7 Since the support body 132 can be accommodated in the mounting groove 1311, it can be known that the main body 131 has a cavity inside. The mounting groove 1311 that is radially through the main body 131 can be understood as the mounting groove 1311 penetrating one side wall of the main body 131, or penetrating two side walls of the main body in the radial direction. The number of mounting grooves 1311 penetrating the side walls of the main body 131 corresponds to the number of support bodies 132.

[0063] Specifically, the supporting body 132 has a U-shaped structure, which can be understood as the cross-sectional structure of the supporting body 132 having a U-shaped structure. The distribution of the first wall and the second wall of the supporting body 132 does not have to completely follow the U-shaped structure.

[0064] In some embodiments, see Figure 14 and Figure 15 The two second walls 1323 are connected to the two opposite sides of the first wall 1322. In this way, the first wall 1322 and the second wall 1323 are connected as a whole, so that when the drive mechanism pushes the supporting body 132, it can push the supporting body 132 as a whole, without setting up separate drive mechanisms to drive the second wall 1323 and the first wall 1322 separately.

[0065] In some embodiments, see Figure 10 and Figure 11In the extended state, the first wall 1322 extends fully out of the mounting groove, at least a portion of the second wall 1323 extends out of the mounting groove, and the bone cement channel also forms a second opening 1362 facing the proximal end. Thus, in the expanded state, the first wall 1322 fully extends out of the mounting groove, forming a scheme with a second opening 1362 based on the first opening 1361. Corresponding bone cement outlets are provided at both the proximal and distal ends, namely the first opening 1361 and the second opening 1362, so that bone cement has outlets at both the proximal and distal ends of the expanded body 132, which is conducive to the bone cement fully filling the proximal and distal ends of the expanded body 132. The bone cement discharge hole 135 provided on the first wall 1322 and / or the second wall 1323 of the expanded body 132 allows the bone cement to be discharged along the circumference of the expanded body 132, which is conducive to the bone cement fully filling the circumferential direction of the expanded body 132. In summary, the coordinated arrangement of the bone cement discharge hole 135, the first opening 1361 and the second opening 1362 is conducive to improving the uniformity of bone cement diffusion in the circumferential direction of the expanded device.

[0066] In some embodiments, see Figure 10 and Figure 11 Bone cement outlet holes 135 are provided on both the first wall 1322 and the two second walls 1323. This arrangement of bone cement outlet holes 135 on both the first wall 1322 and the two second walls 1323 results in a wider distribution range of the bone cement outlet holes 135 and an increased number of corresponding angles, which facilitates more uniform dispersion of bone cement within the vertebral body. The bone cement outlet holes 135 are evenly distributed.

[0067] In some embodiments, see Figure 10 and Figure 11 The extended state includes a parallel extended state where the extender 132 extends parallel to the mounting groove, and an inclined extended state where the extender 132 extends obliquely to the mounting groove; see also Figure 10 In the parallel extended state, the opening area of ​​the first opening 1361 is equal to the opening area of ​​the second opening 1362; see also Figure 11 In the inclined open state, the opening area of ​​the first opening 1361 is larger than the opening area of ​​the second opening 1362. This leads to the two open states of the open body 132. The choice between the parallel open state and the inclined open state can be made according to the requirements.

[0068] In some embodiments, see Figure 11In the tilted expansion state, the distal opening is larger than the proximal opening, that is, the opening area of ​​the first opening 1361 is larger than the opening area of ​​the second opening 1362. In the vertebral body, the distal expansion angle is larger than the proximal angle. This expansion method can more effectively pull the posterior ligament structure, thereby more fully expanding the area of ​​the spinal canal and nerve root canal. Compared with parallel expansion, it can achieve more effective indirect decompression and provide more space for the nerve root.

[0069] In the embodiments, see Figure 3 and Figure 4 After the vertebral implant 1 is placed into the vertebral body, the implantation tool 2 can engage with the threaded sleeve 15 to form a synchronously rotating structure, such as the engagement method of a hexagonal inner hole. The implantation tool 2 drives the threaded sleeve 15 to rotate, thereby driving the pusher 14, which is threadedly connected to the threaded sleeve 15 but cannot rotate, to move axially to the distal end. The pusher 14 drives the locking block 141 to move in the locking groove 1321, thereby driving the expander 132 to move distally and expand radially. After expanding to the set position, bone cement is introduced into the vertebral body through the bone cement inlet channel 137 set in the vertebral implant 1 and the bone cement inlet channel 137 set in the middle of the implantation tool 2. When in the tilted expanded state, the bone cement is simultaneously discharged from the vertebral implant 1 along the first opening 1361, the second opening 1362 and the bone cement outlet hole 135.

[0070] See Figure 14 and Figure 15 For the non-rotatable connection structure formed by the supporting body 132 and the pushing member 14, the supporting body 132 is provided with a slot 1321, and the pushing member 14 is provided with a locking block 141. The locking block 141 is engaged in the slot 1321, so that the supporting body 132 and the pushing member 14 can only rotate synchronously and cannot rotate relative to each other. Furthermore, see... Figure 1 The supporting body 132 cannot rotate relative to the main body 131. The supporting body 132 can only move a certain distance relative to the main body 131 in the radial and axial directions when it is opened. It can be inferred that the supporting body 132 and the main body 131 can only rotate synchronously and cannot rotate relative to each other.

[0071] In some embodiments, see Figure 6 The self-tapping unit 12 includes a cutting portion 121, which is frustoconical in shape and has multi-threaded outer periphery. The cutting portion 121 is configured to cut bone tissue to form a bottom hole during vertebral implantation. The smaller end of the frustoconical cutting portion 121 is located at the distal end of the cutting portion 121 and connects to the proximal end of the positioning unit 11, while the larger end of the frustoconical cutting portion 121 is located at the proximal end of the cutting portion 121. Thus, the self-tapping unit 12, with its cutting portion 121, can quickly penetrate the vertebral body through its multi-threaded structure. Specifically, after the positioning unit is pressed against the vertebral body, the smaller end of the frustoconical cutting portion 121 directly contacts the vertebral body and performs the tapping.

[0072] The proximal end of the self-tapping unit 12 is connected to the distal end of the spreading unit 13, and the distal end of the self-tapping unit 12 is connected to the proximal end of the positioning unit 11. The self-tapping unit 12 is used to self-tape into the vertebral body.

[0073] Specifically, the advantages of using multi-start threaded tapping are: the distance traveled per revolution is longer, requiring fewer revolutions to achieve the same implantation depth compared to ordinary mechanical threads; the time for continuous friction and heat generation between the multi-start thread and bone material is shorter, reducing torque peaks, decreasing the feeling of jamming, and significantly reducing the risk of thermal necrosis, providing a better biological environment for bone healing; it has good anti-dislodgement performance, effectively preventing loosening and withdrawal; the multi-start thread is equivalent to "parallel" multiple force paths on the screw, and the stress is more evenly distributed across more thread surfaces during implantation, reducing stress concentration on individual threads and improving the overall pull-out strength and long-term stability of the screw.

[0074] In some embodiments, see Figure 6 The multi-start thread consists of multiple cutting teeth 1211 spaced apart along the circumferential direction. Chip removal grooves 1212 are formed between adjacent cutting teeth 1211, and the crests of the cutting teeth 1211 are constructed as cutting edges 1213. In this way, the structure of the multi-start thread with its spaced cutting teeth 1211 and chip removal grooves 1212 allows the cutting edges 1213 of the cutting teeth 1211 to cut bone to perform cutting and hole enlargement, so that bone chips can enter the adjacent chip removal grooves 1212 and be discharged in a timely manner.

[0075] In some embodiments, see Figure 6 The cutting teeth 1211 are evenly spaced on the outer periphery of the cutting part 121, and there are five of them. In this way, the teeth of the cutting part 121 are evenly distributed in the circumferential direction to achieve a symmetrical balance of forces, thereby ensuring the centering, stability and high efficiency of the cone-shaped opening device with self-tapping structure during the penetration process.

[0076] In some embodiments, see Figure 6 The self-tapping unit 12 also includes a thread forming part 122, the distal end of which is connected to the proximal end of the cutting part 121. Its outer diameter is larger than the outer diameter of the large end of the frustum-shaped cutting part 121, and its outer periphery is provided with a first mechanical thread 1221, which is configured to tap a first internal thread on the inner wall 1312 of the bottom hole. In this way, the self-tapping section is provided with a thread forming part 122, which taps a more precise internal hole compared to the coarser bottom hole tapped by the cutting part 121; if only the cutting part 121 is used to tap the hole, the tapped bottom hole will be larger than required; in addition, the first internal thread tapped by the first mechanical thread 1221 can provide the internal thread connection structure required for the threaded fastening connection of subsequent units.

[0077] In some embodiments, see Figure 9 The thread forming part 122 is truncated cone-shaped, and the small end of the truncated cone of the thread forming part 122 is connected to the cutting part 121. In this way, the truncated cone-shaped structure of the thread forming part 122 allows for better connection between the thread forming part 122 and the cutting part 121.

[0078] In some embodiments, see Figure 7 and Figure 8 The vertebral body expansion device includes an expansion unit 13, a fastening unit 16, and a connecting unit 17. The expansion unit 13 can be radially expanded, and the outer diameter of the expansion unit 13 is smaller than the outer diameter of the large end of the frustum-shaped threaded part 122. The distal end of the expansion unit 13 is connected to the proximal end of the threaded part 122. The distal end of the fastening unit 16 is connected to the proximal end of the expansion unit 13, and the outer periphery of the fastening unit 16 is provided with a second mechanical thread 161. The distal end of the connecting unit 17 is connected to the proximal end of the fastening unit 16. The outer diameter of the second mechanical thread 161 is not greater than the outer diameter of the large end of the frustum-shaped threaded part 122. When the vertebral body implant 1 is implanted into the vertebral body, the second mechanical thread 161 engages with the first internal thread. Alternatively, the outer diameter of the second mechanical thread 161 is greater than the outer diameter of the large end of the frustum-shaped threaded part 122. When the vertebral body implant 1 is implanted into the vertebral body, the second mechanical thread 161 taps out a second internal thread that engages with the second mechanical thread 161 based on the first internal thread. Thus, the spreading unit 13 spreads the vertebral body after the spreading device is inserted into the vertebral body at the set position; the fastening unit 16 achieves a threaded connection with the vertebral body through the second mechanical thread 161 set on the outer periphery, including two cases: the first case is that the second mechanical thread 161 cooperates with the first internal thread to form a threaded connection structure; the second case is that when the outer diameter of the second mechanical thread 161 is larger than the outer diameter of the large end of the frustum-shaped thread forming part 122, the second mechanical thread 161 will tap a second internal thread that cooperates with the second mechanical thread 161 on the basis of the bottom hole of the first internal thread; the connecting unit 17 is used as a connection structure with the device that assists the spreading device in entering the vertebral body, such as the connecting unit 17 being connected to the implantation tool 2, and the spreading device is driven to rotate and enter the vertebral body under the rotation of the implantation tool 2.

[0079] In some embodiments, see Figure 7 The outer diameter of the second mechanical thread 161 is larger than the outer diameter of the large end of the frustum-shaped thread forming part 122, and the axial length of the second mechanical thread 161 is larger than the axial length of the first mechanical thread 1221. Thus, the outer diameter of the second mechanical thread 161 being larger than the outer diameter of the large end of the frustum-shaped thread forming part 122 allows for re-expansion and tapping when the fastening section is inserted, resulting in a tighter threaded connection between the fastening section and the cone body.

[0080] In some embodiments, see Figure 6 and Figure 9The positioning unit 11 is conical, with the distal end of the positioning unit 11 being the small end of the cone and the proximal end being the large end of the cone. This defines the conical structure of the positioning unit 11, allowing it to connect better with the self-tapping unit 12.

[0081] In the embodiments, see Figure 6 A transition unit 18 is provided between the self-tapping unit 12 and the positioning unit 11. The transition unit 18 is also in the shape of a frustum. The small end of the frustum of the self-tapping unit 12 is connected to the large end of the frustum of the transition unit 18, and the small end of the frustum of the transition unit 18 is connected to the large end of the cone of the positioning unit 11.

[0082] Specifically, the implantation tool 2 is connected to the connecting unit 17 so that the implantation tool 2 and the connecting unit 17 can rotate synchronously. The implantation tool 2 drives the connecting unit 17 to rotate, thereby driving the entire vertebral body implant 1 to rotate and penetrate into the vertebral body. When penetrating the vertebral body, the tip of the positioning unit 11 first penetrates the cortical bone for positioning, and then penetrates into the vertebral body through the self-tapping unit 12. Then it gradually penetrates into the vertebral body to the set position, and then the vertebral body implant 1 is opened to complete the implantation of the vertebral body implant 1. Finally, the implantation tool 2 is removed.

[0083] In the embodiments, see Figure 11 and Figure 12 The main body 131 is divided into an inner layer 1313 and an outer layer 1314, which are nested together to form the main body 131.

[0084] In the description of this invention, it should be understood that the terms "center," "length," "axial," "radial," "circumferential," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In this invention, unless otherwise expressly specified and limited, the terms "installed," "connected," "joined," "fixed," etc., should be interpreted broadly. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0085] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0086] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A self-tapping, expandable system for a vertebral body, characterized in that, The self-tapping expandable system includes: The vertebral implant (1) has a self-tapping structure and a radially expandable expansion unit (13) arranged sequentially from the distal end to the proximal end along its axial direction. The implantation tool (2) is detachably connected to the proximal end of the vertebral implant (1) and is used to apply a rotational force to the vertebral implant (1) to drive the vertebral implant (1) to rotate synchronously and penetrate the vertebral body through the self-tapping structure. It is also used to drive the opening unit (13) to open after the vertebral implant (1) moves to a predetermined position in the vertebral body.

2. The self-tapping expandable system for a vertebral body according to claim 1, characterized in that, The expanding unit (13) includes: The main body (131) has its axial distal end connected to the self-tapping structure; Two expandable bodies (132) are radially slidably connected to the main body (131), and the two expandable bodies (132) have a closed state and an expanded state; In the closed state, the outer contours of the main body (131) and the two supporting bodies (132) together form a cylindrical surface; In the extended state, the two extending bodies (132) move radially outward a set distance relative to the main body (131).

3. The self-tapping expandable system for a vertebral body according to claim 2, characterized in that, The expanding unit (13) further includes: A groove (133) and a slider (134) are provided, one on the main body (131) and the other on each of the supporting bodies (132), and the slider (134) is movably provided in the groove (133); The slide (133) includes a first slide (1331), the extension direction of the first slide (1331) forms an acute angle with the axial direction of the supporting unit (13); when the slider (134) moves along the first slide (1331), it drives the supporting body (132) to move synchronously in the axial and radial directions.

4. The self-tapping expandable system for a vertebral body according to claim 3, characterized in that, The main body (131) includes a mounting groove (1311) extending radially therethrough for accommodating two of the expanders (132); the mounting groove (1311) has two opposing inner walls (1312) parallel to the axis of the main body (131), each inner wall (1312) having two first sliding grooves (1331) located at the proximal end and two first sliding grooves (1331) located at the distal end, and each expander (132) having four sliders (134). Each of the aforementioned expanders (132) is movably engaged with the four aforementioned sliders (134) and the four aforementioned first grooves (1331); wherein two of the aforementioned sliders (134) engage with a proximal first groove (1331) and a distal first groove (1331) on one of the aforementioned inner walls (1312), and the other two of the aforementioned sliders (134) engage with a proximal first groove (1331) and a distal first groove (1331) on another of the aforementioned inner walls (1312); The groove (133) further includes: The second groove (1332) has its proximal end connected to the distal end of the first groove (1331) located at the proximal end, and extends in a direction parallel to the axial direction. The third groove (1333) has its proximal end connected to the distal end of the first groove (1331) located at the distal end, and extends along a length direction parallel to the first groove (1331).

5. The self-tapping expandable system for a vertebral body according to claim 4, characterized in that, The expanding unit (13) further includes: Bone cement discharge hole (135) is opened through the outer peripheral wall of the support body (132); The bone cement discharge opening (136) forms an open gap between the proximal and / or distal ends of the support body (132) and the outer surface of the main body (131) when the support body (132) is in the supported state, and the gap constitutes the bone cement discharge opening (136). The bone cement inlet channel (137) is located in the middle of the axial direction of the vertebral implant (1) and the implantation tool (2) and is connected to the bone cement outlet hole (135) and the bone cement outlet opening (136), respectively.

6. The self-tapping expandable system for a vertebral body according to claim 2, characterized in that, The vertebral implant (1) further includes a pusher (14) and a threaded sleeve (15) connected by threads from the distal end to the proximal end. At least a portion of the pusher (14) extends axially between the two expanders (132). The pusher (14) is provided with a protruding locking block (141). The expander (132) is provided with a strip-shaped locking groove (1321) that mates with the locking block (141). The locking block (141) is accommodated in the locking groove (1321) so that the expander (132) can move radially relative to the pusher (14) when it moves axially with the pusher (14). The threaded sleeve (15) is threaded to the proximal end of the pusher (14); The implantation tool (2) includes: The inner rod (21) is axially detachably connected at its distal end to the proximal end of the threaded sleeve (15) in a manner that can transmit torque; The outer tube (22) is rotatably sleeved on the outer side of the inner rod (21), and its distal end is detachably threaded to the proximal end of the vertebral implant (1), and its proximal end is provided with a first tooth (221). The connector (23) and the inner rod (21) form a mating structure that can move axially relative to each other and rotate synchronously through a keyway structure, and a second tooth (231) is provided at its far end. in, When the first tooth (221) and the second tooth (231) are in a meshing state, the inner rod (21), the outer tube (22) and the connector (23) rotate synchronously; When the first tooth (221) and the second tooth (231) are separated, the inner rod (21) can move and rotate axially relative to the outer tube (22).

7. The self-tapping expandable system for a vertebral body according to claim 6, characterized in that, The vertebral implant (1) also includes: The fastening unit (16) is connected to the proximal end of the spreading unit (13), and its outer periphery is provided with external threads; The connecting unit (17) is connected to the proximal end of the fastening unit (16) and is detachably threaded to the outer tube (22).

8. The self-tapping expandable system for a vertebral body according to claim 7, characterized in that, The connecting unit (17) has a U-shaped structure, and one bottom end of the U-shape is connected to the fastening unit (16). The connecting unit (17) includes: Two support arms (171) are formed on the two side walls of the U-shape, and are provided with internal threads and connected to the external thread structure of the outer tube (22); A weak groove (172) is provided on the two support arms (171) near the bottom of the U-shape, and the radial cross-sectional area of ​​the weak groove (172) is smaller than that of other parts of the support arms (171); A connecting hole (173) is radially opened at the bottom of the U-shape.

9. The self-tapping expandable system for a vertebral body according to claim 1, characterized in that, The self-tapping structure includes: The self-tapping unit (12) has its proximal end connected to the distal end of the spreading unit (13), and its radial outer periphery is surrounded by self-tapping threads; The positioning unit (11) has a distal end that is a pointed tip for positioning when it is inserted into the vertebral body, and its proximal end is connected to the distal end of the self-tapping unit (12).

10. The self-tapping expandable system for a vertebral body according to claim 1, characterized in that, The self-tapping expandable system also includes: The locator (3) is detachably connected to the implantation tool (2) and is used to locate the position of the vertebral implant (1) placed into the vertebral body.

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