An intelligent intervertebral spacer

Abstract

The present invention relates to the field of medical device technology, and discloses an intelligent intervertebral spacer, comprising a transverse central axis, a plurality of longitudinal axes arranged perpendicular thereto and clamped side by side on the central axis, and a spacer unit slidably connected to each other on the longitudinal axis on both sides of the central axis, the spacer unit comprising a slider, a spacer handle connected below each slider, the spacer handle being used to be inserted between adjacent vertebrae, and a drive mechanism being provided between the slider and the longitudinal axis; the spacer unit located in the middle of the central axis is defined as a main spacer, and the remaining spacers are defined as auxiliary spacers, the main spacer is provided with a pressure sensor and a position sensor, and the auxiliary spacer is provided with a pressure sensor; and a control unit is further provided, the pressure sensor, the position sensor, and the drive mechanism being communicatively connected to the control unit. The present invention, by providing multiple spacer units to simultaneously space the intervertebral space, avoids stress concentration and fractures during vertebral spacer expansion, and can monitor the pressure exerted on each spacer unit and the spaced height of the middle vertebrae in real time, avoiding reliance on subjective judgment, and is particularly suitable for patients with osteoporosis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular discloses an intelligent intervertebral spacer. Background Art

[0002] In anterior cervical spine surgery, after the diseased intervertebral disc is removed and before the posterior protruding disc is decompressed, the narrow intervertebral space will affect the operating space and safety during the operation. At this time, an intervertebral spacer is needed to expand the narrow intervertebral space ( Figure 1 ); and use the Caspar distractor to insert distractor pins into the upper and lower vertebrae as a fulcrum, and then use the distractor handle to distract and maintain ( Figure 2 ), maintain a reasonable height of the intervertebral space to facilitate the next step of decompression and fusion device implantation. In this process, if the patient is an elderly patient, perimenopausal woman or other patient with osteoporosis or low bone density, Figure 1 When the intervertebral spacer shown is used for distraction, the contact points are small, resulting in high local stress. This stress concentration can lead to fracture or collapse of the upper and lower vertebral endplates (the interface between the vertebral body and the intervertebral disc). Using the Caspar spacer requires inserting two screws into the anterior vertebral body, an invasive procedure that inherently traumatizes the vertebral body. For patients with osteoporosis, the drilling and screw insertion process can cause vertebral fractures. Endplate or vertebral fractures can prevent fusion device implantation, leading to surgical failure, heavy bleeding, bone fragments falling into the spinal canal, causing spinal cord compression and paralysis, severe postoperative pain, and intraoperative fractures, leading to vertebral collapse or stress fractures after surgery. Furthermore, because bone density varies between osteoporosis patients and at different locations on the endplate within the same patient, the maximum stress they can withstand also varies. When using existing intervertebral spacers for distraction, surgeons cannot determine the bone density and distraction pressure of different regions of the patient's endplates, and therefore cannot determine whether there is a risk of fracture during distraction. They also cannot determine the distraction height (distance), resulting in a mismatch between the distraction height and the trial model and the height of the implanted fusion device. Excessive distraction will apply excessive stress, increasing the risk of fracture; insufficient distraction height will prevent the fusion device from being implanted. All of these factors lead to difficulties in intraoperative distraction for osteoporosis patients, and there is an urgent need to design an intelligent intervertebral spacer suitable for osteoporosis patients. Summary of the Invention

[0003] To address the deficiencies in the prior art, the present invention provides an intelligent intervertebral spacer, which is particularly suitable for patients with osteoporosis and increases contact points and contact areas during spacer expansion, thereby reducing stress concentration.

[0004] In order to achieve the above technical objectives, the technical solution adopted by the present invention is:

[0005] An intelligent intervertebral spacer comprises a transverse central axis, on which a plurality of longitudinal axes arranged perpendicular thereto are clamped side by side, and on the longitudinal axis, two expansion units are slidably connected respectively on both sides of the central axis, the expansion units comprising sliders, each of which is connected to a expansion handle below, the expansion handle being used to be inserted between adjacent vertebrae, a driving mechanism is provided between the slider and the longitudinal axis, the driving mechanism drives the slider to perform linear motion along both sides of the longitudinal axis to drive the expansion handle to expand the adjacent vertebrae; a power module is provided on the longitudinal axis, the power module provides electrical energy to the driving mechanism;

[0006] The expansion unit connected to the longitudinal axis in the middle of the central axis is defined as the main expander, and the units located on both sides of the main expander are secondary expanders. The two expansion handles of the main expander are both equipped with pressure sensors and position sensors. The two expansion handles of the secondary expander are also equipped with pressure sensors. The pressure sensors are used to monitor the pressure applied to each expansion handle, and the position sensors are used to monitor the expansion height.

[0007] It also includes a control unit. The pressure sensor, position sensor, and driving mechanism are communicatively connected to the control unit. The control unit controls the movement of the driving mechanism according to the signals monitored by the pressure sensor and position sensor.

[0008] As an optimal technical solution, the spreader handle is provided with an end plate fitting adaptive structure, including multiple spreader rods, and movable joints are provided between adjacent spreader rods. Adjacent spreader rods adjust relative angles through the movable joints to achieve fitting with the end plate bone surface.

[0009] As a preferred technical solution, the movable joint includes a rotating shaft and a rotating motor. The adjacent stretching rods that are closer to the slider are defined as proximal stretching rods, and the ones that are farther away are defined as distal stretching rods. The rotating shaft is fixed at the proximal end of the distal stretching rod, and the rotating shaft is rotatably connected to the proximal stretching rod. The rotating motor is fixed at the distal end of the proximal stretching rod, and the rotating motor is transmission-connected to the rotating shaft. The rotating motor drives the rotating shaft to rotate, thereby driving the distal stretching rod fixed to it to rotate around the rotating shaft.

[0010] As a preferred technical solution, the movable joints are communicatively connected to the control unit, each movable joint is controlled individually, and the movable joints in the same expansion handle work sequentially from far to near, driving the expansion handle to fit the end plate sequentially from the end to the root.

[0011] As a preferred technical solution, an electric signal receptor is provided at the end of the spreading handle, and the electric signal receptor is communicatively connected with the control unit.

[0012] As a preferred technical solution, the driving mechanism includes a motor and a gear rack mechanism. The motor is installed on the slider, the output shaft of the motor is connected to the gear, the rack is set on the longitudinal axis, the gear is meshed with the rack, the motor drives the gear to rotate, and the gear moves along the rack to make the slider move on the longitudinal axis.

[0013] As a preferred technical solution, the driving mechanism includes a motor and a ball screw. The motor is installed at one end of the longitudinal axis. One end of the screw of the ball screw is connected to the output shaft of the motor through a coupling, and the other end is rotatably connected to the mounting seat on the longitudinal axis. The nut of the ball screw is fixedly connected to the slider. The motor drives the screw to rotate, and drives the slider to move linearly on the longitudinal axis through the nut.

[0014] As a preferred technical solution, it also includes a control module, the control unit is arranged in the control module, the control unit is wirelessly connected to the expansion unit, the control module is also provided with a display unit, the display unit is used to display the stress value monitored by the pressure sensor and the expansion height monitored by the position sensor; the control module is provided with a control interaction button, and the control interaction button is electrically connected to the control unit.

[0015] As a preferred technical solution, the central axis is segmented and provided with a plurality of central axis segments, and adjacent central axis segments are detachably connected.

[0016] As a preferred technical solution, adjacent central axis segments are slidably connected via a slot and a block.

[0017] The beneficial effects of the present invention are:

[0018] The intelligent intervertebral spacer of the present invention, by arranging multiple distraction units to simultaneously distract the intervertebral space, avoids stress concentration and fractures during vertebral distraction, and can monitor the pressure on each distraction unit and the distraction height of the middle part of the vertebra in real time. Once the stress suddenly decreases, it is determined that a microfracture has occurred, and the corresponding distraction handle immediately stops distraction. It can avoid the problems of unknown fractures caused by the distraction process, excessive or insufficient distraction height, and the need to rely on the surgeon's experience for subjective judgment. The surgeon can select an appropriate distraction distance according to the height of the fusion device to facilitate the placement of the fusion device. The present invention can avoid stress concentration and vertebral trauma, reduce the risk of fractures, and is particularly suitable for patients with osteoporosis.

[0019] The intelligent intervertebral spacer of the present invention has an endplate-fitting adaptive structure of the spacer handle, which enables the spacer handle to fit the endplate, increasing the contact points and contact surface with the endplate, and further reducing stress concentration.

[0020] The intelligent intervertebral spacer of the present invention has a segmented central axis, and the central axis segments and the spacer units are detachable. After the spacer is opened, the central central axis segments and the spacer units can be removed, while the spacer units at the outermost edges on both sides continue to provide support, which can provide operating space for subsequent intervertebral operations and facilitate surgical operations; it also simplifies the intraoperative spacer process and the number of instruments used. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0022] Figure 1 It is a schematic diagram of using an intervertebral spacer to open a narrow intervertebral space in the prior art;

[0023] Figure 2 It is a schematic diagram of using a Caspar distractor to distract a narrow intervertebral space in the prior art.

[0024] Figure 3 is a schematic top view of an embodiment of the present invention;

[0025] Figure 4 is a front view schematic diagram of an embodiment of the present invention;

[0026] Figure 5 yes Figure 4 A side view schematic diagram of

[0027] Figure 6 is a schematic diagram of the application process of an embodiment of the present invention;

[0028] Figure 7 It is a structural diagram of the driving mechanism;

[0029] Figure 8 It is a structural diagram of the control module.

[0030] Figure markings: 1-central axis, 2-longitudinal axis, 3-slider, 4-spreading handle, 41-spreading rod, 42-movable joint, 5-main spreader, 6-auxiliary spreader, 7-pressure sensor, 8-position sensor, 9-electrical signal sensor, 10-gear, 11-rack, 12-screw, 13-nut, 14-control module, 15-display unit, 16-control button, 17-power module, 18-indicator light, 101-central axis segment, 102-card slot, 103-card block. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the application for protection, but merely represents the selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0032] An intelligent intervertebral spacer, such as Figure 3-Figure 5 As shown, it includes a transverse central axis 1, on which a plurality of longitudinal axes 2 arranged perpendicular to the central axis 1 are clamped side by side, and the longitudinal axis 2 is slidably connected to the expansion units on both sides of the central axis 1, and the expansion units include a slider 3, and a expansion handle 4 is connected below each slider 3, and the expansion handle 4 is used to be inserted between adjacent vertebrae. A driving mechanism is provided between the slider 3 and the longitudinal axis 2, and the driving mechanism drives the slider 3 to move linearly to both sides along the longitudinal axis 2 to drive the expansion handle 4 to expand the adjacent vertebrae; a power supply module 17 is provided on the longitudinal axis, and the power supply module 17 provides electrical energy for the driving mechanism; the expansion unit connected to the longitudinal axis 2 in the middle of the central axis 1 is defined as a main expander 5, and located on both sides of the main expander 5 are auxiliary expanders 6, and the two expansion handles 4 of the main expander 5 are provided with pressure sensors 7 and position sensors 8 at the roots, and the two expansion handles 4 of the auxiliary expander 6 are provided with pressure sensors 7 at the roots, and the pressure sensors 7 are used to monitor the pressure on each expansion handle 4, and the position sensors 8 are used to monitor the expansion height; It also includes a control unit. The pressure sensor 7, the position sensor 8, and the driving mechanism are in communication with the control unit. The control unit controls the movement of the driving mechanism according to the signals monitored by the pressure sensor 7 and the position sensor 8.

[0033] Furthermore, the spreader handle 4 is provided with an end plate fitting adaptive structure, including a plurality of spreader rods 41, and a movable joint 42 is provided between adjacent spreader rods 41. Adjacent spreader rods 41 adjust their relative angles through the movable joint 42 to achieve the effect of fitting with the irregularly shaped end plate bone surface. Preferably, the movable joint 42 includes a rotating shaft and a rotary motor, and the spreader rod closer to the slider 3 among the adjacent spreader rods is defined as the proximal spreader rod, and the one farther away is the distal spreader rod. The rotating shaft is fixed to the proximal end of the distal spreader rod, and the rotating shaft is rotatably connected to the proximal spreader rod. The rotary motor is fixed to the distal end of the proximal spreader rod, and the rotary motor is transmission-connected to the rotating shaft. The rotary motor drives the rotating shaft to rotate, thereby driving the distal spreader rod fixed thereto to rotate around the rotating shaft to achieve the adjustment of the relative angle between the proximal spreader rod and the distal spreader rod. The movable joint 42 is communicatively connected to the control unit, and each movable joint 42 is controlled separately.

[0034] The working process of the end plate fitting adaptive structure is as follows: after the diseased intervertebral disc is removed during surgery, when the intervertebral space needs to be expanded, the expansion handle 4 is inserted into the intervertebral space, such as Figure 6 As shown in (a); the farthest movable joint drives the expansion rod 41 at the end of the expansion handle 4 to rotate and probe the end plate. When the pressure sensor 7 senses pressure, it stops. The movable joints work in sequence from far to near, so that each expansion rod 41 fits with the end plate one by one starting from the end until the root of the expansion handle 4. At the same time, the driving mechanism drives the slider 3 to slide toward the end plate until the expansion handle 4 is completely fitted with the end plate. Figure 6 (b)

[0035] Preferably, an electrical signal receptor 9 is provided at the end of the expansion handle 4, and the electrical signal receptor 9 is communicatively connected to the control unit. When the end of the expansion handle 4 contacts the spinal cord, the electrical signal receptor 9 can sense the instantaneous change of the electrical signal and transmit the signal to the control unit. The control unit controls the activation of the farthest movable joint 42, so that the expansion rod 41 at the end of the expansion handle rotates to reach the end plate, thereby avoiding further damage to the spinal cord.

[0036] When the expansion handle 4 is completely attached to the end plate, the control unit sends a command to make the expansion units on the longitudinal axis 2 move synchronously to both sides to slowly expand the adjacent vertebrae. Figure 6As shown in (c), at this point, the pressure sensors 7 at the base of all distraction handles 4 are coupled and synchronously distracted, with all pressure sensors 7 sharing the distraction stress equally. During the distraction process, the stress on the pressure sensors 7 at the base of the distraction handles 4 should normally increase gradually. If the stress on any pressure sensor 7 suddenly drops, it is determined that a microfracture has occurred at that location. The two distraction units connected to the longitudinal axis 2 then cease operation, while the remaining distraction handles 4 continue to distribute the distraction stress equally and slowly distract. If the primary distractor 5 encounters a sudden decrease in stress, it maintains contact with the endplate (zero stress) and continues to move up and down with the remaining secondary distractors 6, ensuring its distance measurement function. Preferably, an indicator light 18 is provided on the slider 3 of each distraction unit. This indicator light 18 is in communication with a control unit, which controls the color of the indicator light 18 based on the monitoring results of the pressure sensors 7. For example, when a distraction unit is distracting, the indicator light 18 illuminates green. When the distraction unit stops operating, the indicator light 18 illuminates red, providing a prompt.

[0037] The two position sensors 8 on the main expander 5 are responsible for detecting the expansion height and transmitting it to the control unit. It should be noted that because the intervertebral disc height of the human cervical spine (including the thoracic and lumbar vertebrae) is greatest in the center and gradually decreases toward the sides, the expansion height is measured at the center (main expander) to prevent insufficient expansion. When the position sensors 8 on the main expander 5 detect that the desired expansion height has been reached, expansion is terminated. At this point, all expanders remain in their expanded state, maintaining the expansion effect, except for the expander that stops expanding due to a sudden decrease in stress.

[0038] Furthermore, the driving mechanism is in communication with the control unit, and the control unit controls the start and stop of the driving mechanism. In a preferred embodiment, the driving mechanism includes a motor and a rack and pinion mechanism, such as Figure 3 As shown, the motor (not shown in the figure) is installed on the slider 3, the output shaft of the motor is connected to the gear 10, and the rack 11 is set on the longitudinal axis 2. The gear 10 is meshed with the rack 11. The motor drives the gear 10 to rotate, and the gear 10 moves along the rack 11, thereby causing the slider 3 to move on the longitudinal axis 2. In another preferred embodiment, as Figure 7 As shown, the driving mechanism includes a motor and a ball screw. The motor is installed at one end of the longitudinal axis 2. One end of the screw 12 of the ball screw is connected to the output shaft of the motor through a coupling, and the other end is rotatably connected to the mounting seat on the longitudinal axis 2. The nut 13 of the ball screw is fixedly connected to the slider 3. The motor drives the screw 12 to rotate, and drives the slider 3 to move linearly on the longitudinal axis 2 through the nut 13.

[0039] Furthermore, it also includes a control module 14, such as Figure 8As shown, the control unit is arranged in the control module 14, and the control unit is wirelessly connected to the expansion unit. The control module 14 is also provided with a display unit 15, and the display unit 15 is used to display the stress value monitored by the pressure sensor 7 and the expansion height monitored by the position sensor 8; the control module 14 is provided with a control button 16, and the control button 16 includes "adaptive fit", "expansion start", "expansion end" and a setting button. The setting button includes "distance +" and "distance -", which are used to set the pre-expansion height, and the pre-expansion height is displayed on the display unit 15.

[0040] Furthermore, the central axis 1 is divided into sections and is provided with a plurality of central axis segments 101, and adjacent central axis segments 101 are detachably connected. Preferably, adjacent central axis segments 101 are slidably connected by means of a slot 102 and a block 103. Preferably, the slot 102 and the block 103 are in a "T" shape. After the distraction is completed, because the surgeon may need to perform further operations on the intervertebral space, and the next step is to maintain the distraction height to implant the fusion device, all central axis segments and distractors except the most edge central axis segment 101 and the auxiliary distractor 6 are removed by sliding the slot 102 and the block 103, while maintaining the distraction state, leaving the central area for the surgeon to operate. The two outermost auxiliary distractors are left to support the uncovertebral joint area, that is, the hardest part of the upper and lower endplate cortical bones, which can withstand the corresponding stress, and the implanted fusion device does not cover the uncovertebral joint area on both sides. The retention of these two auxiliary distractors will not affect the implantation of the fusion device. After completing all operations, loosen the auxiliary spreaders at the outermost edges on both sides to complete the operation.

[0041] Of course, the present invention may have many other embodiments. Without departing from the spirit and essence of the present invention, those skilled in the art may make various corresponding changes and modifications based on the present invention, but these corresponding changes and modifications should all fall within the scope of protection of the claims attached to the present invention.

Claims

1. An intelligent intervertebral spacer, characterized by: It includes a transverse central axis, on which a plurality of longitudinal axes arranged perpendicular thereto are clamped side by side, and on the longitudinal axis, two sides of the central axis are respectively slidably connected to the expansion units, the expansion units include sliders, and a expansion handle is connected below each slider, and the expansion handle is used to be inserted between adjacent vertebrae. A driving mechanism is provided between the slider and the longitudinal axis, and the driving mechanism drives the slider to make a linear motion along both sides of the longitudinal axis to drive the expansion handle to expand the adjacent vertebrae; a power module is provided on the longitudinal axis, and the power module provides electrical energy to the driving mechanism; The expansion unit connected to the longitudinal axis in the middle of the central axis is defined as the main expander, and the units located on both sides of the main expander are secondary expanders. The two expansion handles of the main expander are both equipped with pressure sensors and position sensors. The two expansion handles of the secondary expander are also equipped with pressure sensors. The pressure sensors are used to monitor the pressure applied to each expansion handle, and the position sensors are used to monitor the expansion height. The apparatus further comprises a control unit, wherein the pressure sensor, the position sensor, and the driving mechanism are in communication with the control unit, and the control unit controls the movement of the driving mechanism according to the signals monitored by the pressure sensor and the position sensor; The spreader handle is provided with an end plate fitting adaptive structure, including a plurality of spreader rods, and movable joints are provided between adjacent spreader rods. Adjacent spreader rods adjust relative angles through the movable joints to achieve fitting with the end plate bone surface.

2. The intelligent intervertebral spacer according to claim 1, characterized in that: The movable joint includes a rotating shaft and a rotating motor. The adjacent stretching rods that are closer to the slider are defined as the proximal stretching rod, and the ones that are farther away are defined as the distal stretching rod. The rotating shaft is fixed at the proximal end of the distal stretching rod, and the rotating shaft is rotatably connected to the proximal stretching rod. The rotating motor is fixed at the distal end of the proximal stretching rod, and the rotating motor is transmission-connected to the rotating shaft. The rotating motor drives the rotating shaft to rotate, thereby driving the distal stretching rod fixed to it to rotate around the rotating shaft.

3. The intelligent intervertebral spacer according to claim 2, characterized in that: The movable joints are in communication with the control unit, and each movable joint is controlled individually. The movable joints in the same spreader handle work in sequence from far to near, driving the spreader handle to fit the end plate in sequence from the end to the root.

4. The intelligent intervertebral spacer according to claim 1, characterized in that: An electric signal receptor is provided at the end of the spreading handle, and the electric signal receptor is communicatively connected with the control unit.

5. The intelligent intervertebral spacer according to claim 1, characterized in that: The driving mechanism includes a motor and a gear rack mechanism. The motor is installed on the slider. The output shaft of the motor is connected to the gear. The rack is set on the longitudinal axis. The gear is meshed with the rack. The motor drives the gear to rotate, and the gear moves along the rack to make the slider move on the longitudinal axis.

6. The intelligent intervertebral spacer according to claim 1, characterized in that: The driving mechanism includes a motor and a ball screw. The motor is installed at one end of the longitudinal axis. One end of the screw of the ball screw is connected to the output shaft of the motor through a coupling, and the other end is rotatably connected to the mounting seat on the longitudinal axis. The nut of the ball screw is fixedly connected to the slider. The motor drives the screw to rotate, and drives the slider to move linearly on the longitudinal axis through the nut.

7. The intelligent intervertebral spacer according to claim 3, characterized in that: It also includes a control module, the control unit is arranged in the control module, the control unit is wirelessly connected to the expansion unit, the control module is also provided with a display unit, the display unit is used to display the stress value monitored by the pressure sensor and the expansion height monitored by the position sensor; the control module is provided with a control interaction button, and the control interaction button is electrically connected to the control unit.

8. The intelligent intervertebral spacer according to claim 1, characterized in that: The central axis is divided into sections and is provided with a plurality of central axis segments, and adjacent central axis segments are detachably connected.

9. The intelligent intervertebral spacer according to claim 8, characterized in that: Adjacent central shaft segments are slidably connected via clamping grooves and clamping blocks.

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