Intervertebral fusion test mold and method capable of adjusting height and monitoring pressure

Abstract

The invention discloses a height-adjustable and pressure-monitoring intervertebral fusion test mold and method, and relates to the field of medical implantation tools, the test mold comprises a test mold main body, a guide tube and a holding device; the test mold main body comprises a height adjusting module, a pressure monitoring module and a data processing unit; the height adjusting module is located in the test mold body and adjusts the height of the test mold body through rotation of the screw. The pressure monitoring module is positioned on the contact surface of the test mold main body and is used for monitoring pressure distribution between the test mold and the upper and lower end plates of the cone in real time; the data processing unit is arranged in the test mold main body; the holding device comprises a display screen and an adjusting knob, and the display screen is located on the surface of the holding device; the adjusting knob is located at the end of the holding device and used for controlling the screw to rotate and adjusting the height of the height adjusting module. The device can be continuously adjusted within a certain range, the height size of an interbody fusion cage matched with a patient can be accurately adjusted, and the pressure between the interbody upper end plate and the interbody lower end plate borne by the test mold can be quantitatively output.

Description

Technical Field

[0001] This application relates to the field of medical implant tools, and more specifically, to an adjustable height and pressure monitoring interbody fusion prototype and method. Background Technology

[0002] Interbody fusion is a surgical procedure used to treat spinal diseases, which involves implanting a fusion cage between adjacent vertebrae to promote bone fusion. Currently, in clinical practice, different sizes of trial molds (8mm, 10mm, 12mm, and 14mm) are inserted into the intervertebral space either through a channel or directly. (See [link to relevant documentation]). Figure 1 The doctor observes the degree of matching between the mold and the intervertebral space, such as whether it can be placed stably and how well it fits the endplates of the upper and lower vertebral bodies. Then, the doctor selects the appropriate size fusion device based on his own experience and intraoperative C-arm fluoroscopy.

[0003] This approach, which relies entirely on the surgeon's experience, has the following main problems:

[0004] 1. Limited Accuracy: Even experienced physicians cannot perfectly determine the most suitable fusion cage size, and there may be some error. For example, if the selected fusion cage is too high, it may lead to difficulty in placement, excessive stretching of the intervertebral space, increasing the chance of nerve root traction injury, and increasing stress on adjacent segments, thus increasing the incidence of degeneration. Excessive load on the intervertebral fusion cage can also lead to problems such as increased subsidence rate. If the selected fusion cage is not high enough, it will not be able to restore the intervertebral height and lumbar lordosis, and may also lead to intervertebral fusion cage displacement and fusion failure.

[0005] 2. Low efficiency: It requires trying different models of molds one by one, which increases the operation time and has a certain adverse effect on both patients and doctors. The extended operation time may increase the risk of complications such as infection.

[0006] 3. Lack of unified standards: Currently, there is a lack of a comprehensive, detailed, and quantifiable standard system for the selection of interbody fusion devices, which forces doctors to rely on their own experience and judgment, making it difficult to eliminate individual differences.

[0007] Given that the current method of selecting interbody fusion devices relies entirely on the surgeon's experience, which has limitations in accuracy and efficiency, and that individual differences among doctors in selection criteria are difficult to quantify, it is necessary to carry out innovative design.

[0008] Prior art document 1 (CN117695065B) discloses a real-time stress monitoring intervertebral fusion test mold, relating to the field of intervertebral fusion surgery technology, including: a test mold body providing support, a deformation structure, and a strain structure. After the test mold body enters the intervertebral disc space, the deformation structure undergoes elastic deformation under pressure, and the strain structure measures the pressure it bears and provides feedback to the surgeon. However, because the stress-bearing shell of the test mold body entering the intervertebral space is made of elastic material, the test mold body will undergo elastic deformation under pressure. It is a pressure sensor based on the strain effect principle, which can only obtain the pressure value between the superior and inferior endplates of the intervertebral disc, but cannot obtain the height of the test mold under the corresponding pressure value, and therefore cannot guide the selection of the fusion cage size in clinical surgery.

[0009] Prior art document 2 (CN116712224A) discloses a variable-size intelligent trial mold tool, including: a size-adjustable measuring head and an adjustment device for adjusting the size of the measuring head, wherein the measuring head is connected to the adjustment device. The measuring head includes at least two surfaces and an elastic connecting part for connecting the surfaces into a sealed whole, and the pressure sensor group is disposed on the outer surface of each surface. However, on the one hand, it adjusts the size of the trial mold by the amount of gas injected. Since the volume of gas changes during the pressurization process, the height value may not be accurate, and there will be stability problems if there is no self-locking device. On the other hand, this invention trains the model by associating the experience of qualified surgeons with the selection of trial mold height through deep learning, but the selection of the interbody fusion cage is still in the trial mold detection stage during the operation. Therefore, it also uses existing fusion cages and cannot fundamentally achieve the goal of preoperative image judgment and individualized customization of fusion cages to achieve precision medicine. Summary of the Invention

[0010] To address the shortcomings of existing technologies, this invention provides an intervertebral fusion test model and method that can adjust the height and monitor pressure.

[0011] The present invention adopts the following technical solution.

[0012] The first aspect of the present invention discloses an adjustable height and pressure monitoring intervertebral fusion test mold, comprising a test mold body, a guide tube, and a holding device connected in sequence. The test mold body includes a height adjustment module, a pressure monitoring module, and a data processing unit, used to probe between the superior and inferior endplates of the patient's intervertebral disc to measure the height of the vertebral bodies that are adapted to different individuals. The height adjustment module is disposed inside the test mold body and adopts a screw and nut screw-nut screw mechanism, and the height of the height adjustment module is adjusted by rotating the screw.

[0013] The pressure monitoring module is set on the contact surface of the test mold body and includes multiple pressure sensors for real-time monitoring of the pressure distribution between the test mold and the vertebral body. The data processing unit is set inside the test mold body to receive and process the data from the pressure sensors.

[0014] The gripping device includes a display screen and an adjustment knob. The display screen is located on the surface of the gripping device and is used to receive and display pressure data. The adjustment knob is located at the end of the gripping device and is used to control the rotation of the screw and adjust the height of the height adjustment module.

[0015] Preferably, the height adjustment module includes a screw, a nut, and an adjustment block;

[0016] The adjusting block includes a first adjusting block and a second adjusting block, which are arranged opposite to each other. A nut is fixed inside the second adjusting block, and a screw passes through the first adjusting block and is connected and fixed to the nut.

[0017] Preferably, the height adjustment module further includes a moving block, which includes a first moving block and a second moving block. The first moving block and the second moving block are arranged opposite to each other and fixed to the inner surface of the mold body. Both the adjustment block and the moving block are trapezoidal structures, and the side of the adjustment block abuts against the side of the moving block.

[0018] Preferably, the screw is located inside the guide tube, with one end of the screw connected to the height adjustment module and the other end connected to the adjustment knob.

[0019] Preferably, the adjustment knob drives the screw to rotate, and the screw moves the adjustment block by cooperating with the nut inside the second adjustment block. When the first and second adjustment blocks move towards each other, the adjustment blocks squeeze and drive the two moving blocks to move away from each other, thereby opening the height adjustment module for height adjustment.

[0020] Preferably, the adjustment knob includes a dial and a pointer. The pointer of the adjustment knob corresponds to the value on the dial, which is the height of the height adjustment module. The adjustment range of the height adjustment module is 7-15mm, and the accuracy is 0.1mm.

[0021] Preferably, the thread lead on the screw is designed to be 0.5 mm / turn.

[0022] Preferably, the holding device further includes a locking structure, which is disposed on the adjustment knob, and locks the adjustment knob by means of the locking structure after adjustment is completed.

[0023] Preferably, the gripping device further includes a circuit board disposed inside the gripping device and electrically connected to the data processing unit and the display screen via wires for signal transmission.

[0024] A second aspect of the present invention discloses a method for adjusting an interbody fusion test model, based on the aforementioned adjustable height and pressure monitoring interbody fusion test model, comprising the following steps:

[0025] Rotate the adjustment knob to perform a trial mold zeroing;

[0026] The test mold body is placed between the upper and lower endplates of the intervertebral disc using a holding device;

[0027] Rotating the adjustment knob turns the screw, causing the height adjustment module to change height. The value on the dial corresponding to the pointer of the adjustment knob is the height of the height adjustment module. The pressure monitoring module monitors the pressure from between the upper and lower endplates and displays the pressure reading on the screen to provide feedback on the force on the test mold within the intervertebral space, thus completing the selection of the intervertebral fusion device.

[0028] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0029] 1. Addressing the technical problems of existing trial molds having fixed height dimensions and low accuracy in selecting interbody fusion devices, this invention provides a trial mold height that can be continuously adjusted within a certain range (7-15mm), allowing for the tailored determination of the appropriate interbody fusion device height for each patient, laying the foundation for individualized interbody implantation. Furthermore, it quantifies the pressure between the upper and lower endplates of the intervertebral disc during the height adjustment process, directly solving the problems of inconvenient height adjustment and insufficient accuracy of existing interbody fusion trial molds.

[0030] 2. This invention integrates high-precision pressure sensors at key stress-bearing locations on the trial mold, enabling real-time monitoring of pressure changes between the mold and the intervertebral space during height adjustments. The pressure sensors convert the monitored pressure signals into electrical signals, which are then transmitted wirelessly to a display screen. Doctors can observe the pressure data in real time while adjusting the height of the trial mold. Compared to traditional trial molds, this pressure monitoring function provides timely feedback on the stress on the mold within the intervertebral space, preventing excessive or insufficient pressure from affecting the fusion outcome. It provides crucial real-time data support for surgery, helping doctors better understand the mold's working status within the body, adjust surgical procedures promptly, and improve the safety and effectiveness of the surgery. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the intervertebral fusion test model described in this invention;

[0032] Figure 2 This is a schematic diagram of the structure of the prototype body described in this invention;

[0033] Figure 3 This is a schematic diagram of the structure of the holding device described in this invention;

[0034] Figure 4This is a schematic diagram of the prototype body in this invention positioned between the cones;

[0035] In the diagram: 1. Trial mold body; 101. Height adjustment module; 1001. Screw; 1002. Nut; 1003. First adjusting block; 1004. Second adjusting block; 1005. First moving block; 1006. Second moving block; 102. Pressure monitoring module; 103. Data processing unit;

[0036] 2. Guiding tube;

[0037] 3. Holding device; 301. Display screen; 302. Locking structure; 303. Adjustment knob. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of this invention. The embodiments described in this application are merely some embodiments of this invention, and not all embodiments. Based on the spirit of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this invention.

[0039] like Figure 1-3 As shown, the present invention provides an adjustable height and pressure monitoring interbody fusion test mold, comprising a test mold body 1, a guide tube 2 and a holding device 3 connected in sequence;

[0040] The test mold body 1 includes a height adjustment module 101, a pressure monitoring module 102, and a data processing unit 103. The test mold body 1 is made of titanium alloy and includes upper and lower contact surfaces. It is used to probe between the upper and lower endplates of the patient's intervertebral disc to provide support and measure the height of the fit between different individual vertebrae.

[0041] It is worth noting that, such as Figure 4 As shown, the front end of the test mold body 1 is set in a rounded arc shape, which can achieve a tight fit with the upper and lower endplates during the process of inserting the test mold between the vertebrae, adjusting the height and taking it out, and prevent the metal edges from damaging the upper and lower endplates.

[0042] The pressure monitoring module 102 is disposed on the contact surface, that is, multiple pressure sensors are embedded in the upper and lower contact surfaces of the test mold body to monitor the pressure distribution between the test mold and the cone body in real time, and send the data to an external display device through wires;

[0043] The height adjustment module 101 is located inside the test mold body 1 and adopts a spiral lifting structure with a micro titanium alloy screw and nut.

[0044] Specifically, the height adjustment module 101 includes a screw 1001, a nut 1002, an adjustment block, and a moving block;

[0045] The adjusting block includes a first adjusting block 1003 and a second adjusting block 1004, which are arranged opposite to each other. A nut 1002 is fixed inside the second adjusting block 1004. The screw 1001 passes through the first adjusting block 1003 and is connected and fixed to the nut 1002.

[0046] The moving block includes a first moving block 1005 and a second moving block 1006, which are arranged opposite to each other and fixed to the inner surface of the mold body 1 respectively.

[0047] Both the adjusting block and the moving block have a trapezoidal structure, with the side of the adjusting block abutting against the side of the moving block.

[0048] When the screw 1001 is rotated, the adjustment block moves by cooperating with the nut 1002 inside the second adjustment block. When the first adjustment block 1003 and the second adjustment block 1004 move towards each other, the adjustment block squeezes and drives the two moving blocks to move away from each other, thereby opening up the test mold body 1 and realizing the height adjustment of the test mold body 1, thus realizing the height adjustment of the intervertebral fusion test mold.

[0049] The data processing unit 103 is integrated inside the test mold body 1 and is used to receive and process data from the pressure sensor.

[0050] One end of the test mold body 1 is connected to the holding device 3 through the guide tube 2.

[0051] The gripping device 3 includes a display screen 301, a locking structure 302, and an adjustment knob 303;

[0052] The display screen 301 is disposed on the upper surface of the gripping device 3 and is used to receive and display pressure data to assist doctors in making surgical decisions. The gripping device 3 also contains a circuit board, which is electrically connected to the data processing unit 103 and the display screen 301 via wires for signal transmission.

[0053] The adjustment knob 303 is located at the rear end of the gripping device 3, the locking structure 302 is located on the adjustment knob 303, and the screw 1001 is located inside the guide tube 2, with one end connected to the height adjustment module 101 and the other end connected to the adjustment knob 303.

[0054] By rotating the adjustment knob 303 on the handle, the screw 1001 is rotated, and the height adjustment module 101 is raised and lowered, thereby driving the distance between the upper and lower contact surfaces of the mold body 1 to change, so as to realize the continuous adjustment of the mold height.

[0055] In a preferred but non-limiting embodiment of the present invention, the adjustment knob 303 can be connected to an external wrench to increase the lever arm. By rotating the external wrench, the height adjustment module 101 can be adjusted more easily.

[0056] The adjustment knob 303 includes a scale and a pointer. The value on the scale corresponding to the pointer of the adjustment knob 303 is the height of the test mold body 1. Its adjustment range is 7-15mm, and the accuracy can reach 0.1mm.

[0057] Furthermore, the thread lead on the screw 1001 is designed to be 0.5 mm / turn, thus enabling millimeter-level fine-tuning (e.g., 1 turn = 1 mm of opening height) precision control.

[0058] After adjustment, the mold body is fixed by locking structure 302 to prevent it from retracting during the operation. Locking structure 302 can be a ratchet or a threaded self-locking mechanism.

[0059] It is worth noting that this invention employs a unique height adjustment structure within the main body of the trial mold. By operating the adjustment knob, the guide tube rotates, driving the main body of the trial mold to move precisely up and down, thereby achieving accurate adjustment of the trial mold's height. Compared to existing fixed trial molds, this structure offers high adjustment precision and stability, meeting the personalized needs of different patients for intervertebral disc height, and playing a crucial role in improving the accuracy and success rate of surgery.

[0060] Embodiment 2 of the present invention provides a method for adjusting an interbody fusion trial model based on adjustable height and pressure monitoring, comprising the following steps:

[0061] Step 1: Perform trial molding and zeroing;

[0062] Specifically, rotate the adjustment knob 303 until the pointer points to the smallest mark 7 on the dial. At this point, the height of the test mold body is 7mm.

[0063] Step 2: Place the test mold body 1 between the upper and lower endplates of the intervertebral disc using the holding device 3;

[0064] Step 3: Rotate the adjustment knob 303. The screw in the guide tube 2 rotates, causing the height adjustment module 101 of the test mold body 1 to change in height. The value on the dial corresponding to the pointer of the adjustment knob 303 is the height of the test mold body. The pressure monitoring module 102 monitors the pressure from between the upper and lower end plates and transmits it to the circuit board through wires. The pressure reading is displayed on the screen to provide feedback on the force situation of the test mold in the intervertebral space.

[0065] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0066] 1. Addressing the technical problems of existing trial molds having fixed height dimensions and low accuracy in selecting interbody fusion devices, this invention provides a trial mold height that can be continuously adjusted within a certain range (7-15mm), allowing for the tailored determination of the appropriate interbody fusion device height for each patient, laying the foundation for individualized interbody implantation. Furthermore, it quantifies the pressure between the upper and lower endplates of the intervertebral disc during the height adjustment process, directly solving the problems of inconvenient height adjustment and insufficient accuracy of existing interbody fusion trial molds.

[0067] 2. This invention integrates high-precision pressure sensors at key stress-bearing locations on the trial mold, enabling real-time monitoring of pressure changes between the mold and the intervertebral space during height adjustments. The pressure sensors convert the monitored pressure signals into electrical signals, which are then transmitted wirelessly to a display screen. Doctors can observe the pressure data in real time while adjusting the height of the trial mold. Compared to traditional trial molds, this pressure monitoring function provides timely feedback on the stress on the mold within the intervertebral space, preventing excessive or insufficient pressure from affecting the fusion outcome. It provides crucial real-time data support for surgery, helping doctors better understand the mold's working status within the body, adjust surgical procedures promptly, and improve the safety and effectiveness of the surgery.

[0068] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the specific implementation of the present invention. Any modifications or equivalent substitutions that do not depart from the spirit and scope of the present invention should be covered within the protection scope of the claims of the present invention.

Claims

1. An adjustable height and pressure monitoring interbody fusion trial, comprising a trial body (1), a guide tube (2) and a holding device (3) connected in sequence, characterized in that: the trial body (1) comprises a height adjustment module (101), a pressure monitoring module (102) and a data processing unit (103), which is used to explore between the upper and lower endplates of the patient's intervertebral disc, measure the height of the intervertebral body adaptation of different individuals; the height adjustment module (101) is arranged inside the trial body (1), adopts a screw and nut matched screw lifting structure, and adjusts the height of the height adjustment module (101) through the rotation of the screw; the pressure monitoring module (102) is arranged on the contact surface of the trial body (1) and comprises a plurality of pressure sensors for real-time monitoring of the pressure distribution between the trial and the vertebral body; the data processing unit (103) is arranged inside the trial body (1) and receives and processes the data of the pressure sensor; the holding device (3) comprises a display screen (301) and an adjustment knob (303), the display screen (301) is arranged on the surface of the holding device (3) and is used to receive and display pressure data; the adjustment knob (303) is arranged at the end of the holding device (3) and is used to control the rotation of the screw and adjust the height of the height adjustment module (101).

2. The adjustable height and pressure monitoring interbody fusion trial according to claim 1, characterized in that: the height adjustment module (101) comprises a screw (1001), a nut (1002) and an adjustment block; the adjustment block comprises a first adjustment block (1003) and a second adjustment block (1004), which are oppositely arranged, the nut (1002) is fixed inside the second adjustment block (1004), and the screw (1001) is connected and fixed with the nut (1002) through the first adjustment block (1003).

3. The adjustable height and pressure monitoring interbody fusion trial according to claim 2, characterized in that: the height adjustment module (101) further comprises a moving block, the moving block comprises a first moving block (1005) and a second moving block (1006), the first moving block (1005) and the second moving block (1006) are oppositely arranged and respectively fixed to the inner surface of the trial body (1), the adjustment block and the moving block are both ladder structures, and the side surface of the adjustment block abuts against the side surface of the moving block.

4. The adjustable height and pressure monitoring interbody fusion trial according to claim 2, characterized in that: the screw (1001) is located in the guide tube (2), one end of the screw (1001) is connected with the height adjustment module (101), and the other end is connected with the adjustment knob (303).

5. The adjustable height and pressure monitoring interbody fusion trial according to claim 2, characterized in that: ​ The adjusting knob (303) drives the screw rod (1001) to rotate, and moves the adjusting block by cooperating with the nut (1002) inside the second adjusting block. When the first adjusting block (1003) and the second adjusting block (1004) move towards each other, the adjusting block extrudes and drives the two moving blocks to move away from each other, thereby expanding the height adjustment module (101) to adjust the height.

6. The height-adjustable and pressure-monitored interbody fusion cage according to claim 1, characterized in that: The adjusting knob (303) includes a scale and a pointer, and the value on the scale corresponding to the pointer of the adjusting knob (303) is the height of the height adjustment module (101). The adjustment range of the height adjustment module (101) is 7-15 mm, and the accuracy is 0.1 mm.

7. The height-adjustable and pressure-monitored interbody fusion cage according to claim 2, characterized in that: The pitch of the screw thread on the screw rod (1001) is designed to be 0.5 mm / turn.

8. The height-adjustable and pressure-monitored interbody fusion cage according to claim 1, characterized in that: The holding device (3) further includes a locking structure (302) arranged on the adjusting knob (303), which locks the adjusting knob (303) after the adjustment is completed.

9. The height-adjustable and pressure-monitored interbody fusion cage according to claim 1, characterized in that: The holding device (3) further includes a circuit board arranged inside the holding device (3) and electrically connected to the data processing unit (103) and the display screen (301) through wires for signal transmission.

10. An interbody fusion cage adjusting method based on the height-adjustable and pressure-monitored interbody fusion cage according to any one of claims 1-9, characterized in that: The method includes the following steps: Rotating the adjusting knob (303) to adjust the zero of the cage; Placing the cage body (1) between the upper and lower endplates of the intervertebral space through the holding device (3); Rotating the adjusting knob (303) to rotate the screw rod and drive the height adjustment module (101) to change the height. The value on the scale corresponding to the pointer of the adjusting knob (303) is the height of the height adjustment module (101). The pressure monitoring module (102) monitors the pressure from the upper and lower endplates, and the display screen (301) displays the pressure reading to feedback the stress condition of the cage in the intervertebral space, and completes the selection of the interbody fusion cage.

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