CN120420020B - Intelligent intervertebral spreader - Google Patents

Abstract

The invention relates to the technical field of medical appliances and discloses an intelligent intervertebral spreader which comprises a transverse central shaft, a plurality of longitudinal shafts which are arranged vertically on the central shaft in a clamping manner, a spreading unit which is arranged on two sides of the central shaft and is respectively connected with the spreading units in a sliding manner, wherein the spreading unit comprises sliding blocks, a spreading handle is connected below each sliding block and is used for being inserted between adjacent vertebrae, a driving mechanism is arranged between each sliding block and the longitudinal shaft, the spreading unit which is positioned in the middle of the central shaft is defined as a main spreader, the rest is an auxiliary spreader, a baroreceptor and a position receptor are arranged on the main spreader, the baroreceptor is arranged on the auxiliary spreader, and the intelligent intervertebral spreader further comprises a control unit, the baroreceptor, the position receptor and the driving mechanism are in communication connection with the control unit. According to the invention, the plurality of expanding units are arranged to synchronously expand the intervertebral space, so that the occurrence of fracture caused by stress concentration during the expansion of the vertebral body is avoided, the pressure born by each expanding unit and the expansion height of the middle part of the vertebral body can be monitored in real time, the dependence on subjective judgment is avoided, and the method is particularly suitable for osteoporosis patients.

Description

An intelligent intervertebral spacer

Technical Field

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

Background Art

During anterior cervical spine surgery, after resection of the diseased intervertebral disc and before decompression of the posterior disc herniation, a narrow intervertebral space can compromise intraoperative space and safety. In this situation, an intervertebral spacer is used to expand the narrow intervertebral space (Figure 1). Using a Caspar spacer, screws are inserted into the upper and lower vertebrae, acting as a fulcrum. The spacer handle then maintains the space (Figure 2), maintaining a suitable intervertebral height to facilitate the subsequent decompression and fusion device placement. During this procedure, in elderly patients, perimenopausal women, and those with osteoporosis or low bone density, the use of the intervertebral spacer (Figure 1) can lead to high localized stress due to the small contact points. This stress concentration can cause fracture or collapse of the upper and lower vertebral endplates (the interface between the vertebral body and the intervertebral disc). The use of the Caspar spacer requires the insertion of two screws in 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 lead to failure of fusion device implantation, resulting in surgical failure, massive bleeding, bone fragments falling into the spinal canal, resulting in compression of the spinal cord and paralysis, severe pain in patients after surgery, intraoperative fractures, and subsequent vertebral collapse or stress fractures in patients after surgery, among other serious clinical consequences. In addition, due to the different bone densities among different osteoporosis patients and in different locations of the endplates of the same patient, the maximum stress they can withstand is also different. When using existing intervertebral spacers for distraction, surgeons cannot judge the bone density and distraction pressure of different areas of the patient's endplates, and therefore cannot judge whether there is a risk of fracture during distraction; they cannot judge the distraction height (distance), resulting in the distraction height not matching the trial mold or the height of the implanted fusion device. Excessive distraction will apply excessive stress and increase the risk of fracture; insufficient distraction height will result in the inability to implant the fusion device. In summary, intraoperative distraction for osteoporosis patients faces difficulties, and there is an urgent need to design an intelligent intervertebral spacer suitable for osteoporosis patients.

Summary of the Invention

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.

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

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;

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

The beneficial effects of the present invention are:

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.

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.

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

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.

FIG1 is a schematic diagram of using an intervertebral spacer to expand a narrow intervertebral space in the prior art;

FIG. 2 is a schematic diagram of using a Caspar distractor to distract a narrow intervertebral space in the prior art.

FIG3 is a schematic top view of an embodiment of the present invention;

FIG4 is a schematic front view of an embodiment of the present invention;

FIG5 is a schematic side view of FIG4;

FIG6 is a schematic diagram of an application process according to an embodiment of the present invention;

FIG7 is a schematic structural diagram of a driving mechanism;

FIG8 is a schematic structural diagram of the control module.

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

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.

3 to 5, an intelligent intervertebral spacer comprises a transverse central axis 1, on which a plurality of longitudinal axes 2 arranged perpendicular thereto are clamped side by side, and on the longitudinal axis 2, expansion units are slidably connected on both sides of the central axis 1, and the expansion units comprise sliders 3, under each of which a expansion handle 4 is connected, and the expansion handle 4 is used to be inserted between adjacent vertebrae, and a driving mechanism is provided between the sliders 3 and the longitudinal axis 2, and the driving mechanism drives the sliders 3 to move linearly to both sides along the longitudinal axis 2 to drive the expansion handles 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.

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.

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, as shown in Figure 6 (a); the farthest end movable joint drives the expansion rod 41 at the end of the expansion handle 4 to rotate and probe the end plate, and when the pressure sensor 7 senses pressure, it stops, and the movable joints work in sequence from far to near, so that each expansion rod 41 is fitted with the end plate one by one starting from the end until the root of the expansion handle 4, and 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, as shown in Figure 6 (b).

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.

When the distraction handle 4 is fully aligned with the endplate, the control unit issues a command, causing the distraction units on the longitudinal axis 2 to move synchronously to the sides, slowly distracting the adjacent vertebrae, as shown in Figure 6(c). At this point, the pressure sensors 7 at the base of all distraction handles 4 are coupled and distracted synchronously, with all pressure sensors 7 evenly sharing the distraction stress. During the distraction process, the stress on the pressure sensors 7 at the base of the distraction handle 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 that longitudinal axis 2 then cease operation, while the remaining distraction handles 4 continue to evenly share the distraction stress and slowly distract. If the primary distractor 5 experiences a sudden decrease in stress, it maintains contact with the endplate (0 stress) and continues to move up and down with the other secondary distractors 6, ensuring its distance measurement function. Preferably, an indicator light 18 is provided on the slider 3 of each expansion unit, and the indicator light 18 is communicated with the control unit. The control unit controls the color of the indicator light 18 according to the results of the monitored pressure sensor 7. For example, when the expansion unit is in the expansion process, the indicator light 18 lights up green. When the expansion unit stops working, the indicator light 18 lights up red to give a prompt.

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.

Furthermore, the drive mechanism is communicatively connected with the control unit, and the control unit controls the start and stop of the drive mechanism. In a preferred embodiment, the drive mechanism includes a motor and a rack-and-pinion mechanism, as shown in FIG3 , the motor (not shown in the figure) is mounted on the slider 3, the output shaft of the motor is connected to the gear 10, the rack 11 is arranged 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 shown in FIG7 , the drive mechanism includes a motor and a ball screw, the motor is mounted 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.

Furthermore, it also includes a control module 14. As shown in Figure 8, 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. 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. The pre-expansion height is displayed on the display unit 15.

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.

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 (9)

1. The intelligent intervertebral spreader is characterized by comprising a transverse central shaft, a plurality of longitudinal shafts which are arranged vertically on the central shaft in a clamped manner, and a spreading unit which is arranged on two sides of the central shaft in a sliding manner, wherein the spreading unit comprises sliding blocks, a spreading handle is connected below each sliding block and is used for being inserted between adjacent vertebrae, a driving mechanism is arranged between each sliding block and the longitudinal shaft, and the driving mechanism drives the sliding blocks to do linear motion along the longitudinal shafts to two sides to drive the spreading handle to spread the adjacent vertebrae;

Defining a spreader unit connected to a longitudinal axis in the middle of a center shaft as a main spreader, arranging auxiliary spreaders on two sides of the main spreader, arranging baroreceptors and position receptors on two spreader handles of the main spreader, arranging baroreceptors on the two spreader handles of the auxiliary spreader, wherein the baroreceptors are used for monitoring the pressure applied by each spreader handle, and the position receptors are used for monitoring the spreader height;

The control unit is in communication connection with the baroreceptors, the position receptors and the driving mechanism, and controls the movement of the driving mechanism according to signals monitored by the baroreceptors and the position receptors;

The expansion handle is provided with an end plate fitting self-adaptive structure and comprises a plurality of expansion rods, movable joints are arranged between the adjacent expansion rods, and the adjacent expansion rods adjust relative angles through the movable joints so as to realize fitting with the end plate bone surfaces.

2. The intelligent intervertebral spreader of claim 1, wherein the movable joint comprises a rotating shaft and a rotating motor, the spreader bars of adjacent spreader bars, which are closer to the sliding block, are defined as proximal spreader bars, the spreader bars of the adjacent spreader bars are further away from the sliding block, the rotating shaft is fixedly arranged at the proximal ends of the distal spreader bars, the rotating shaft is rotationally connected with the proximal spreader bars, the rotating motor is fixedly arranged at the distal ends of the proximal spreader bars, the rotating motor is in transmission connection with the rotating shaft, and the rotating motor drives the rotating shaft to rotate so as to drive the distal spreader bars fixedly connected with the rotating motor to rotate around the rotating shaft.

3. The intelligent intervertebral spreader of claim 2, wherein the movable joints are in communication connection with the control unit, each movable joint is independently controlled, and the movable joints in the same spreading handle work from far to near in sequence to drive the spreading handle to sequentially attach to the end plates from the tail end to the root end.

4. The intelligent intervertebral spreader of claim 1, wherein the end of the spreading handle is provided with an electrical signal sensor which is in communication connection with the control unit.

5. The intelligent intervertebral distractor of claim 1, wherein the driving mechanism comprises a motor and a gear rack mechanism, the motor is arranged on the sliding block, an output shaft of the motor is connected with a gear in a transmission way, the rack is arranged on the longitudinal shaft, the gear is meshed with the rack, the motor drives the gear to rotate, and the gear moves along the rack to enable the sliding block to move on the longitudinal shaft.

6. The intelligent intervertebral spreader of claim 1, wherein the driving mechanism comprises a motor and a ball screw, the motor is arranged at one end of the longitudinal shaft, one end of a screw rod of the ball screw is connected with an output shaft of the motor through a coupler, the other end of the screw rod of the ball screw is rotationally connected with a mounting seat on the longitudinal shaft, a nut of the ball screw is fixedly connected with the sliding block, the motor drives the screw rod to rotate, and the sliding block is driven to linearly move on the longitudinal shaft through the nut.

7. The intelligent intervertebral spreader of claim 3, further comprising a control module, wherein the control unit is arranged in the control module, the control unit is in wireless communication connection with the spreading unit, the control module is further provided with a display unit, the display unit is used for displaying stress values monitored by baroreceptors and spreading heights monitored by position sensors, and the control module is provided with a control interaction key, and the control interaction key is electrically connected with the control unit.

8. The intelligent intervertebral spreader of claim 1, wherein the medial axis is arranged in sections and is provided with a plurality of medial axis segments, and adjacent medial axis segments are detachably connected.

9. The intelligent intervertebral distractor of claim 8 wherein adjacent central shaft segments are slidably connected by a clamping groove and a clamping block.