Integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures

Abstract

The invention discloses an integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, comprising a track, a reduction arm, a hollow screw sleeve and an extended hollow screw; the track is provided with a length scale; the reduction arm connects the track and the extended hollow screw sleeve, the extended hollow screw is sleeved in the hollow screw sleeve, and the distal end of the extended hollow screw is designed as a spiral blade or a thread. The device combines the advantages of good reduction effect of traditional open reduction and internal fixation of thoracolumbar fractures with the advantages of PKP or PVP surgery in terms of immediate pain relief and rapid reconstruction of the stability of the injured vertebra, and achieves good correction of the physiological curvature of the spine, relieves pain and restores the function of the spine under the premise of minimally invasive, simple, safe and effective surgery.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures. Background Art

[0002] With the aging of the population and changes in lifestyle, osteoporosis has become a globally recognized public health issue and is the sixth most common chronic disease in the world. There are currently more than 200 million osteoporosis patients in my country. Osteoporotic vertebral compression fractures (OVCFs) are the most common complication of osteoporosis, and their incidence is increasing year by year, and is expected to reach 50 million cases in 2020. OVCFs cause vertebral collapse and spinal deformation, triggering a series of biomechanical changes in the spine and even nerve damage. [1-2] OVCF has become a major issue that threatens the survival of elderly patients and poses an unprecedented challenge to clinicians. [3] .

[0003] Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are important methods for treating OVCF. PVP is a percutaneous puncture to establish a pedicle channel and inject bone cement into the vertebral body through the above channel; PKP is a pedicle channel to insert an expandable balloon into the vertebral body to expand and reduce the fracture. After the compressed vertebral body is reduced to a satisfactory level, the balloon is removed and bone cement is injected into the vertebral body to finally achieve local stability of the vertebral fracture. [4-5] As early as 2001, Professor Garfin, former president of the North American Spine Society, wrote that OVCF minimally invasive surgery can relieve patients' back pain by 95% and improve their quality of life, which is beyond the reach of traditional treatments. [6] .

[0004] Previous studies have shown that kyphosis is closely related to patient survival. Excessive kyphosis is a potential risk factor for shortened life expectancy in the elderly, and this association increases with the increase of kyphosis. [7]The design principle of PVP and PKP products is to reduce the compressed fractured vertebrae by postural reduction or by expanding the balloon inserted into the vertebral body during surgery. It was found during PVP and PKP that some severely compressed vertebrae could not be effectively reduced, and obvious kyphosis of the spine still existed after surgery. The imbalance of the biomechanical line of the spine may lead to many complications: such as continuous loss of vertebral height after surgery, easy falls that induce another osteoporotic fracture, intractable thoracolumbar and back pain, decreased lung function, digestive system abnormalities, pain in the lower limb hip and knee joints, etc. [8] Some patients even need another surgery. [9] Bone cement leakage is a common complication of PVP and PKP surgery. When bone cement is injected into the vertebral body, it needs to have a certain fluidity. When under pressure, bone cement will flow to the fracture gap, the neurovenous plexus area in the bone defect area, and cause leakage.

[10] The destruction of the posterior wall structure will directly affect the surgical method, because the chance of intraspinal leakage is greatly increased when injecting bone cement during PVP or PKP surgery, and is listed as a contraindication for vertebroplasty in some literature.

[11] .

[0005] Traditional surgical treatment for spinal fractures is open reduction, reduction and fixation through internal fixation. The good reduction effect of fractures has been clinically confirmed by using the intact ligaments around the vertebral body through pedicle reduction.

[12] However, this type of surgery is very traumatic, takes a long time, causes a lot of bleeding, and slows postoperative recovery. OVCF is usually performed on elderly patients with complex and serious medical diseases, so many patients cannot tolerate traditional open internal fixation surgery. Severe osteoporosis internal fixation surgery may also cause adverse consequences such as loosening, breakage, and displacement of the internal fixation, forcing some patients to face another surgery.

[13] Therefore, there are fewer and fewer clinical reports on the traditional open reduction and internal fixation surgery for the treatment of OVCF.

[0006] In summary, exploring surgical treatments for OVCF that are minimally invasive, simple to operate, have good fracture reduction, are safe and reliable, and have definite efficacy remains the main direction for solving the above problems.

[0007] References:

[0008] 1. Chen Hao, Yang Huilin, et al. Considerations on the diagnosis and treatment of osteoporotic vertebral compression fractures[J]. Chinese Journal of Traumatology and Orthopaedics, 2019, 21(4): 366-368.

[0009] 2. Yang Huilin, Liu Qiang, et al. Expert consensus on anti-osteoporosis standard treatment for patients with osteoporotic vertebral compression fractures[J]. Chinese Medical Journal, 2018, 98(11): 803-807.

[0010] 3.Wang G,Yang H,Chen K.Osteoporotic vertebral compression fractureswith intravertebral cleft treated by percutaneous balloon kyphoplasty[J].JBone Joint Surg Br,2010,92(11):1553-1557.

[0011] 4.Lee JH,Lee DO,Lee JH,et al.Comparison of radiological and clinicalresults of balloon kyphoplasty according to anterior height loss in theosteoporotic vertebral fracture[J].Spine,2014,14(10):2281-2289.

[0012] 5.Maestretti G,Sutter P,Monnard E,et al.A prospective study ofpercutaneous balloon kyphoplasty with calcium phosphatecement in traumaticvertebral fractures:10-year results[J].Eur Spine,2014,23(6):1354-1360.

[0013] 6.Garfin SR,Yuan HA,Reìley MA.New technologìes in spine:kyphoplastyand vertebroplasty for the treatment of painful osteoporotic compressionfracture[J].Spine(Phila Pa l976),2001,26(14):1511-1515.

[0014] 7.Kado DM,Duong T,Stone KL,et a1.Incident vertebral fractures andmortalityin older women:aprospective study.Osteoporos Int,2003,14(7):589-594.

[0015] 8.Yu W,Liang,Yao Z,et a1.Risk factors for recollapse of the augmemedvertebrae after percutaneous vertebroplasty for osteoporotic vertebralfractures with intravertebral vacuum eleft[J].Medicine,2017,96(2):e5675.

[0016] 9.Li X,Lu Y,Lin

[0017] 10. Vogl TJ, Pflugmacher R, Hierholzer J, et al. Cement directedkyphoplasty reduces cement leakage as compared with vertebroplasty: results of a controlled, randomized trial [J]. Spine, 2013, 38(20): 1730-1736.

[0018] 11. Lan Tao, Chen Yang, Yang Xinjian. Progress of refracture after vertebroplasty[J]. Chinese Journal of Spine and Spinal Cord, 2015, 25(2): 179-182.

[0019] 12. Wang Xuke, Li Changqing, et al. Combined unidirectional and universal pedicle screw percutaneous fixation of the injured vertebra for the treatment of thoracolumbar fractures[J]. Chinese Journal of Traumatology, 2013, 29(5): 431-437. DOI: 10.3760 / cma.j.issn.1001-8050.2013.05.010.

[0020] 13. Ma Jinfeng, Chen Bohua, Li Juan, et al. Treatment of thoracolumbar fractures by pedicle bone implantation and vertebroplasty combined with pedicle screw fixation[J]. Chinese Journal of Traumatology, 2013, 29(6): 513-515. DOI: 10.3760 / cma.i.issn.1001.8050.2013.06.009.

[0021] 14.Ailon T, Shaffrey CI, Lenke LC, et al. Progressive spinal kyphosis inaging puplation[J]. Neurosurgery, 2015, 77(Suppl 4): S164-172.

[0022] 15. Sadiqi S, Verlaan J, Lehr AM, et al. Measurement of kyphosis and bertebral body height loss in traumatic spine fractures: an international study[J]. Eur Spine J, 2017, 26(5): 1483-1491. Summary of the invention

[0023] In order to solve the above problems in the prior art, the present invention provides an integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, which has the advantages of simple operation, small trauma to patients, good fracture reduction, safety and reliability, etc.

[0024] The present invention provides a vertebral fracture percutaneous minimally invasive in vitro reduction integrated device, comprising a track, a reduction arm, a hollow screw sleeve and an extended hollow screw;

[0025] The track is provided with length scales;

[0026] The reset arm comprises a slide seat and a rotating sleeve which are nested and combined with each other; the slide seat is provided with a first through hole for the track to pass through, and a first locking piece for fixing the relative position of the track and the slide seat; a rotating part which can rotate relative to the rotating sleeve is installed at one end of the rotating sleeve, and a second through hole for the hollow screw sleeve to pass through is provided on the rotating part; a second locking piece for fixing the relative position of the rotating sleeve and the rotating part is also provided on the rotating part; an angle ruler is provided on the rotating sleeve;

[0027] The hollow screw sleeve is a hollow tubular structure;

[0028] The lengthened hollow screw is sleeved in the hollow screw sleeve and is a hollow tubular structure, and the distal end is designed as a spiral blade or a thread.

[0029] Optionally or preferably, in the above-mentioned integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, the upper surface of the track is a rack-shaped length scale; the sliding seat is also provided with a accommodating sleeve, in which a rotating nut is installed, and the outer surface of the rotating nut is serrated and engages with the rack-shaped length scale of the track.

[0030] Optionally or preferably, in the above-mentioned integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, one end of the rotating sleeve close to the rotating part is cylindrical and has serrations on the outer surface to form an angle ruler, and the second button can be engaged and clamped with the serrations when pressed.

[0031] Optionally or preferably, in the above-mentioned integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, the second locking member is also equipped with a wrench, and the wrench is used to lock the second locking member.

[0032] Optionally or preferably, in the above-mentioned integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, the sliding seat is provided with an inner ring with a cylindrical outer circumference, the rotating sleeve is provided with a hollow annular outer ring, and the outer ring is provided with a through hole with an internal thread, the inner ring is nested in the outer ring, and the relative fixation of the inner ring and the outer ring is achieved by screwing a screw into the through hole.

[0033] Optionally or preferably, in the above-mentioned integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, the inner wall of the second through hole of the rotating part is provided with a groove, and the outer wall of the hollow screw sleeve is provided with a protrusion, which is inserted into the groove to fix the hollow screw sleeve in the second through hole.

[0034] Optionally or preferably, in the above-mentioned integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, the rotating part is provided with a blind hole for insertion into the rotating sleeve, and the side wall of the blind hole is provided with a through hole with an internal thread. After the rotating part and the rotating sleeve are inserted into each other, the rotating part and the rotating sleeve are relatively fixed by screwing a screw into the through hole.

[0035] Optionally or preferably, in the above-mentioned integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, the outer surface of the outer wall of the upper end of the elongated hollow screw is a flat structure.

[0036] Optionally or preferably, in the above-mentioned integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, the first locking member and the second locking member are both self-locking buckles with springs, the first locking member is fixed on the sliding seat and pressed on the track by the elastic force of the spring; the second locking member is fixed on the rotating part and pressed on the rotating sleeve by the elastic force of the spring.

[0037] The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures provided by the present invention has the following beneficial effects.

[0038] (1) The device realizes the universal adjustable function through the sliding seat and rotating sleeve of the reduction arm, which is more conducive to the flexible placement of the lengthened hollow screw, shortens the operation time, and reduces the difficulty of the operation; the lengthened hollow screw connected by the two reduction arms divides the anterior and posterior columns of the vertebral body into segments, and the reduction can be performed in steps, making the surgical steps more flexible and reasonable.

[0039] (2) The lengthened hollow screw with a spiral blade or thread can increase the axial contact area in the vertebral body, and the spiral insertion can reduce the loss of pedicle and vertebral bone, improve the reduction effect, and reduce the cutting of the vertebral body during reduction. The design of the percutaneous puncture combined with the lengthened hollow screw of this device improves the safety of puncture and screw placement during surgery and reduces the risk of damaging nerves and blood vessels.

[0040] (3) The length scale on the track and the angle scale on the rotation sleeve of the reduction arm facilitate reference to preoperative imaging measurement data, provide a more accurate reference during surgical reduction, quantify the surgical effect, avoid excessive distraction, and reduce damage to adjacent vertebrae.

[0041] (4) By providing the first locking member and the second locking member, the adjusted position can be locked after each length or angle adjustment. Preferably, when a self-locking buckle with a spring is used, the buckle can be automatically locked after each adjustment operation, thereby further simplifying the operation and shortening the operation time.

[0042] (5) The only consumables required for the device are the puncture needle and the extended hollow screw. The rest are equipment that can be sterilized and reused repeatedly, which greatly reduces the cost of surgery, alleviates the economic burden on patients, and saves social resources. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 This is a schematic diagram of the overall structure of the integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures in Example 1;

[0044] Figure 2 It is a schematic diagram of the track structure, with length scale on the surface;

[0045] Figure 3 It is a schematic diagram of the structure on the back of the track;

[0046] Figure 4 It is a schematic diagram of the slide structure;

[0047] Figure 5 It is a schematic diagram of the rotating nut structure;

[0048] Figure 6 is a schematic diagram of the structure of the first locking member;

[0049] Figure 7 It is a schematic diagram of the rotating sleeve structure;

[0050] Figure 8is a schematic diagram of a second locking structure;

[0051] Fig. 9 is a schematic diagram of the wrench structure;

[0052] Fig.10 It is a schematic diagram of the split structure for locking the second locking member when the wrench is pressed down;

[0053] Fig.11 It is a schematic diagram of the rotating part structure;

[0054] Fig.12 It is a schematic diagram of the structure of an extended hollow screw sleeve;

[0055] Fig.13 This is a schematic diagram of the extended hollow screw structure.

[0056] In the figure:

[0057] 1: track, 11: length scale, 12: inner groove, 2: sliding seat, 21, accommodating sleeve, 211: observation hole, 22: inner ring, 23: locking groove, 24: fixed seat, 25: first through hole, 3: rotating sleeve, 31: outer ring, 32: screw hole, 33: angle ruler, 34: plug-in part, 4: hollow screw sleeve, 41: bump, 5: lengthened hollow screw, 51: hollow hole, 52: threaded or spiral blade, 6: rotating nut, 7: first locking member, 71: first clamping knife, 72: perforation, 73: first finger pressure plate, 8: second locking member, 81: left button, 82: right button, 83: second finger pressure plate, 84: second clamping knife, 85: return angle, 9: wrench, 10: rotating part, 101: second through hole, 102: groove, 103: screw hole. DETAILED DESCRIPTION

[0058] The technical solution of the present invention is explained and illustrated in detail below in conjunction with the accompanying drawings and embodiments, so that those skilled in the art can better understand the present invention and implement it.

[0059] Example 1

[0060] See also Figure 1 It is a type of integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, comprising a track 1, a slide seat 2, a rotating sleeve 3, a rotating part 10, a hollow screw sleeve 4 and an extended hollow screw.

[0061] The sliding seat 2, the rotating sleeve 3 and the rotating part 10 together form a resetting arm structure. The resetting arm is the rotation center of the anterior column of the vertebral body and the mechanical fulcrum for resetting the anterior column of the vertebral body by rotating the hollow screw sleeve 4.

[0062] See also Figure 2 and Figure 3The track 1 is a long plate-like structure with a serrated length scale 11 on the surface, and each serration is equal in size. An inner groove 12 is provided on the back, and the function of the inner groove 12 is to reduce weight and facilitate operation. The track 1 provides a track and a mechanical center for axial resetting.

[0063] See also Figure 4 Combination Figure 1 The slide seat 2 includes a receiving sleeve 21, a cylindrical inner ring 22, a locking groove 23, a fixing seat 24 and a first through hole 25. The first through hole 25 is used for the track 1 to pass through, and the locking groove 23 corresponds to the side of the track 1 with the length scale 11. Figure 5 The housing 21 is used to accommodate the rotating nut 6. The outer surface of the rotating nut 6 is serrated and engages with the rack-shaped length scale 11 of the track 1. The sliding seat 2 can be driven to move relative to the track 1 by rotating the rotating nut 6. The housing 21 is also provided with an observation hole 211 for easy cleaning after surgery. The cylindrical inner ring 22 is used to nest with the outer ring of the rotating sleeve 3. Figure 6 The fixing seat 24 is used to combine with the first locking member 7. The first locking member 7 is installed on the fixing seat 24 by using a fixing shaft with a spring through the through hole 72 of the first locking member 7. The two ends of the spring wire are extended to respectively abut against the first locking member 7 and the fixing seat 24. The position of the first clamping knife 71 corresponds to the locking groove 23. When no force is applied, the elastic action of the spring makes the first clamping knife 71 clamped into the length scale 11 of the track 1 to realize the automatic locking function. When the first finger pressure plate 73 is pressed, the first clamping knife 71 is separated from the track 1.

[0064] See also Figure 7 , Fig.11 Combination Figure 1 The rotating sleeve 3 includes an outer ring 31, an angle ruler 33 and a plug-in portion 34. Figure 4 The outer ring 31 is used to be inserted into the inner ring 22 of the slide 2 to achieve a rotational connection with the slide 2. The outer ring 31 is also provided with a screw hole 32. When the outer ring 31 is rotated to a suitable position, a screw can be screwed into the screw hole 32 to press against the inner ring 22 and then fixed, so that the rotating sleeve 3 and the slide 2 are relatively fixed. The rotating sleeve 3 is plugged with the rotating part 10 through the plug-in part 34. The plug-in part 34 and the outer ring 31 at one end of the rotating sleeve close to the rotating part 10 are cylindrical and have serrations on the outer surface to form an angle ruler 33. The second locking member 8 can be engaged with the serrations of the angle ruler 33 and clamped.

[0065] See also Figure 8 The second locking member 8 is composed of a left button 81 and a right button 82 connected by a fixed shaft (not shown) with a spring, and the two ends of the spring wire are extended to respectively press against the left button 81 and the right button 82. Figure 1The right button 82 is fixed on the rotating part 10, and the upper part of the left button 82 is provided with a second finger pressure plate 83, and the lower part is provided with a second clamping knife 84. When no force is applied, the elastic action of the spring causes the second clamping knife 84 to clamp into the sawtooth of the angle ruler 33, thereby realizing the automatic locking function.

[0066] See also Fig. 9 The wrench 9 is installed on the second locking member 8 to lock the second locking member 8. The wrench 9 is a structure that can rotate within a 90° angle relative to the second locking member 8, similar to the blade of a guillotine. The wrench 9 is provided with a connecting hole, and is installed on the locking member 8 through a rivet or other structure. The connection between the wrench 9 and the second locking member 8 is provided with two baffles: an outer baffle and an inner baffle. Figure 8 After installation, the outer baffle is located on the outside of the right button 82, and the inner baffle is located on the inside of the right button 82 (between the right button 82 and the left button 81). The right button 82 has a folded angle 85 on its side. When the wrench 9 is lifted, the wrench 9 is close to the right-angle structure of the two baffles and away from the second locking member 8. At this time, pinch the left and right buttons 81 and 82, and the folded angle 85 can pass over the side of the left button 81, so that the left and right buttons can move relative to each other (the second finger pressure plate 83 is close to or away from the right button 82). At this time, the second locking member 8 can drive the rotating part 10 and the hollow screw sleeve 4 connected thereto to rotate relative to the reset arm, so that it is convenient to adjust to the expected position. After adjusting to the expected position, press the wrench 9 down again ( Figure 1 The state in Figure 1 Only one wrench 9 is shown, but there are actually two wrenches 9, each of which is equipped with a wrench 9 for each of the two second locking members 8. Fig.10 Combination Figure 1 After pressing the wrench 9, the right-angle structure of the wrench 9 is stuck at the return angle 85 of the right button 82, so that the left button 81 and the right button 82 cannot move relative to each other, that is, the second finger-pressing plate 83 cannot be pinched, thereby fixing the rotating part 10 in a suitable position, which is convenient for later operation. When readjustment is needed, the wrench 9 can be restored by simply lifting it.

[0067] See also Fig.10 The rotating part 10 has a blind hole (not shown) at one end for the plug-in part 34 to be plugged in, and a second through hole 101 at the other end for the hollow screw sleeve 4 to be inserted into. A groove 102 is also provided at the position of the second through hole 101. Fig.12, a protrusion 41 is provided on the outer wall of the hollow screw sleeve 4. When the hollow screw sleeve 4 is inserted into the second through hole 101, the protrusion 41 is inserted into the groove 102 to fix the two to each other. In addition, a screw hole 103 is also provided on the side wall of the blind hole of the rotating part 10. Since the plug-in part 34 of the rotating sleeve 3 is cylindrical, the rotating part 10 can rotate relative to the rotating sleeve 3 after plugging. When adjusted to a suitable rotation position, the rotating sleeve 3 and the rotating part 10 can be relatively fixed by screwing the screw hole 103 against the plug-in part 34.

[0068] See also Fig.12 , 13 The lengthened hollow screw 5 is inserted into the lengthened hollow screw sleeve 4. The lengthened hollow screw 5 is provided with a central hole 51 along the axis and a thread or spiral blade 52 at the lower end. The hollow screw sleeve 4 serves to connect the lengthened hollow screw 5 with the reduction arm, strengthen the strength of the lengthened hollow screw 5, transfer the force on the reduction arm to the surface of the pedicle, and shorten the force arm during the reduction process. The lengthened hollow screw 5 is used for percutaneous minimally invasive placement into the normal vertebra adjacent to the fractured vertebra, providing a mechanical fulcrum for the reduction of the fractured vertebra.

[0069] The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures is used in combination with PVP or PKP surgery and can effectively solve the following problems:

[0070] (1) When OVCF is performed with PVP or PKP alone, the compressed fractured vertebrae in some patients cannot be satisfactorily repositioned and corrected. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures can more effectively and accurately reposition the compressed vertebrae, restore the lost height of the vertebrae, and correct kyphosis.

[0071] (2) Bone cement leakage is a common and serious complication during PVP and PKP surgery, especially posterior vertebral wall fracture, which was once a contraindication for the above surgery. The dual forces of the tension band during the reduction of the vertebral fracture percutaneous minimally invasive extracorporeal reduction device and the balloon expansion of the vertebral body when necessary are used to maximize the restoration of vertebral height and expand the vertebral volume. For patients with posterior vertebral wall fractures, the risk of bone cement leakage during the next PVP\PKP surgical operation is effectively reduced, the safety of the operation is improved, and the surgical indications are expanded.

[0072] (3) Traditional open reduction and internal fixation of spinal fractures has the disadvantages of large trauma, heavy bleeding, long operation time, slow postoperative recovery, internal fixation devices left in the body, stress concentration in adjacent segments of the fixed segment leading to accelerated disc degeneration or vertebral fracture, and high surgical costs. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures is an extracorporeal percutaneous temporary distraction reduction. Combined with PVP or PKP surgery, it can complete reduction under tiny incisions and shorten the operation time and reduce intraoperative bleeding. It not only achieves the effect of open reduction, but also avoids the related complications after internal fixation, reducing the reoperation rate.

[0073] (4) In order to reduce the damage to the adjacent vertebral bodies during the screw placement and reduction process, a spiral blade-shaped pedicle lengthened hollow screw is specially designed. During the screw placement process, the screw head continuously squeezes the surrounding cancellous bone to achieve the effect of bone grafting. Compared with the design of the threaded structure, it can significantly reduce the damage to the adjacent vertebral bodies. At the same time, the screw with a spiral blade head has a larger and stronger contact surface in the vertebral body, which enhances the holding force of the hollow screw and reduces the cutting of the normal vertebral body by the screw during the reduction process.

[0074] The steps are as follows:

[0075] After satisfactory general anesthesia, the patient lies prone on a fluoroscopic operating table, with cushions placed on the chest and bilateral anterior superior iliac spines to suspend the abdomen. Routine disinfection and draping are performed, and sterile surgical films are applied.

[0076] According to the preoperative imaging, the side with the heaviest vertebral compression is selected. Under the fluoroscopic positioning of the C-arm X-ray fluoroscopy machine, the screw insertion point of the pedicle of the same side of the upper and lower vertebrae adjacent to the injured vertebra is determined. An incision of about 0.5 cm is cut on the body surface, and the pedicle puncture needle is inserted along the pedicle. After the C-arm X-ray fluoroscopy machine monitors and determines that the puncture needle position is satisfactory, the guide needle is inserted, the puncture needle is removed, and two elongated hollow screws 5 are inserted into the vertebral body by tapping along the guide needle direction with a bone hammer. The C-arm X-ray fluoroscopy machine determines that the position of the elongated hollow screw 5 is satisfactory (the screw head is located on the line of the spinous process in the anteroposterior position and close to the anterior edge of the vertebral body in the lateral position). The hollow screw sleeve 4 is installed on the elongated hollow screw 5 to ensure that the hollow screw sleeve 4 reaches the surface of the articular process joint, and the track 1 is as close to the skin surface as possible. The external reduction integrated device is connected, and the reduction arm and the track 1 are locked. According to the data of vertebral height loss and angulation measured by preoperative imaging, the injured vertebra was gradually reduced using an extracorporeal reduction device under the monitoring of a C-arm X-ray fluoroscopy machine and with the scale on track 1 as a marker.

[0077] (1) Reducing the height of the posterior column in the vertebral body: ① Lock the position of the hollow screw sleeve 4 relative to the rotating sleeve 3 through the second locking piece 8 on the reduction arm; ② Rotate the rotating nut 6 on the track 1, refer to the length scale 11 on the track 1, gradually expand the reduction arm along the track 1, and restore the height of the posterior column in the vertebral body; After the axial reduction is completed, the track 1 is automatically locked relative to the reduction arm through the first locking piece 7.

[0078] (2) Restore the height of the anterior column of the vertebral body: ① With the axis of the reduction arm as the center, refer to the angle scale 33 of the rotating sleeve 3 on the reduction arm, and gradually rotate the extended hollow screw sleeve 4 on the side of the vertebral end plate compression and collapse in the opposite direction of the vertebral body compression. After the reduction of the anterior column of the vertebral body is satisfactory, the second locking piece 8 is automatically locked; ② If both the upper and lower end plates are compressed, rotate the distal and proximal extended hollow screw sleeves 4 respectively to reduce the height.

[0079] Under the fluoroscopy of the C-arm X-ray machine, puncture the injured vertebra unilaterally through the pedicle. After the puncture needle enters the vertebral body, remove the inner core of the puncture needle and slowly drill the bone drill into the vertebral body along the working sleeve. Remove the bone drill after the drill tip is about 0.5 cm from the front edge of the vertebral body. Place the expansion balloon connected to the pressurizer filled with contrast agent into the vertebral body along the working sleeve so that the balloon is located in the middle of the vertebral body in the anteroposterior position and about 0.5 cm from the front edge of the vertebral body in the lateral position. Under the monitoring of the C-arm X-ray machine, refer to the pressure reading of the pressurizer and the injection volume scale reading, gradually expand the balloon, further restore the vertebral height, and reposition the collapsed end plate. Prepare and stir the bone cement to the "toothpaste period" and inject it into the special bone cement push rod. Slowly, in small amounts, and in multiple injections of bone cement through the working sleeve of the pedicle of the injured vertebra. Observe the diffusion of bone cement in the vertebral body under the fluoroscopy of the C-arm X-ray machine to avoid leakage and overflow.

[0080] Wait for the bone cement to heat up and solidify before removing the percutaneous minimally invasive in vitro reduction integrated device for vertebral fracture and vertebroplasty instrument. Rinse with saline and suture the incision. Apply sterile dressing.

[0081] After the operation, the patient's vital signs are observed to be stable and there are no neurological symptoms after awakening from anesthesia, and the patient can return to the ward. On the first day after the operation, the patient will undergo an X-ray examination, wear a thoracolumbar brace, and walk and be discharged.

[0082] Alternative methods: (1) The anesthesia method can be flexibly selected according to the patient's condition: general anesthesia, local anesthesia + intravenous combined anesthesia or local infiltration anesthesia. (2) Whether the vertebral fracture needs to be temporarily reduced by a percutaneous minimally invasive extracorporeal reduction integrated device and whether balloon dilatation is needed depends on the actual reduction of the vertebral body during each step of the operation: if the vertebral body has been satisfactorily reduced when the patient is in the prone position, there is no need for temporary reduction through the pedicle; if the vertebral body has been reduced after temporary reduction through the pedicle, there is no need for PKP but only PVP; if the reduction is not satisfactory, further assisted reduction with a balloon is required.

[0083] The design concept and advantages of the present invention:

[0084] ① Concept: Double internal and external reduction, direct reduction plus indirect reduction, better reduction effect. Indirect reduction: the tension band principle of pedicle reduction (using the fiber ring, anterior longitudinal ligament and posterior longitudinal ligament connected to the adjacent vertebrae to pull the fractured vertebral body to reduce the fracture fragments of the vertebral body); direct reduction: balloon kyphoplasty (after the balloon placed in the fractured vertebral body is expanded, direct reduction is performed from the inside of the compressed vertebral body).

[0085] ②Advantages: The two surgical methods complement each other and maximize the benefits for patients. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures combines the advantages of traditional open reduction and internal fixation with the advantages of PKP or PVP surgery in immediate pain relief and rapid reconstruction of the stability of the injured vertebra. It avoids the shortcomings of traditional surgery such as large trauma, heavy bleeding, and slow postoperative recovery, as well as the shortcomings of simple PKP or PVP surgery for vertebral compression fractures, high bone cement leakage rate, etc. Under the premise of minimally invasive, simple, safe and effective surgery, it can achieve good correction of the physiological curvature of the spine and restore the patient and spinal function.

[0086] The economic and social benefits of the invention are:

[0087] ① The percutaneous minimally invasive extracorporeal reduction integrated device for vertebral fractures is designed to restore the normal force line lost due to vertebral compression fractures, avoiding the continuous loss of vertebral height caused by spinal imbalance after surgery, easy falls and induce osteoporotic fractures again, intractable chest and waist pain, decreased lung function, digestive system abnormalities, pain in the lower limb hip and knee joints, etc. [8] , improved the functions of multiple organs such as lung function, improved the quality of life of patients after surgery, and reduced the mortality rate caused by OVCF

[14] ;

[0088] ② The whole process is minimally invasive surgery, with little surgical trauma, safe and effective. More patients are more likely to accept and tolerate the surgery, which expands the beneficiary population and reduces the serious complications and high treatment costs caused by conservative treatment for patients who have not undergone surgery or cannot tolerate surgery; ③ Compared with patients with uncorrected spinal alignment, patients with good spinal alignment can reduce the risk of falling and fractures again, reduce the cost of re-hospitalization and related surgeries, and better save social resources. [7，9，15] .

[0089] The invention concept is described in detail using specific examples herein, and the description of the above embodiments is only used to help understand the core idea of ​​the invention. It should be pointed out that any obvious modification, equivalent substitution or other improvement made by a person of ordinary skill in the art without departing from the invention concept should be included in the protection scope of the present invention.

Claims

1. An integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures, characterized in that: It includes a track, a resetting arm, a hollow screw sleeve and an extended hollow screw; The track is provided with length scales; The reset arm comprises a slide seat and a rotating sleeve which are nested and combined with each other, the slide seat is provided with an inner ring with a cylindrical outer circumference, the rotating sleeve is provided with a hollow annular outer ring, and the outer ring is provided with a through hole with an internal thread, the inner ring is nested in the outer ring, and the inner ring and the outer ring are relatively fixed by screwing a screw into the through hole; the slide seat is provided with a first through hole for the track to pass through, and a first locking piece for fixing the relative position of the track and the slide seat; a rotating part is installed at one end of the rotating sleeve, and a blind hole is provided on the rotating part for plugging with the rotating sleeve so that the rotating part can rotate relative to the rotating sleeve; a second through hole is provided on the rotating part for the hollow screw sleeve to pass through; the rotating part is also provided with a second locking piece for fixing the relative position of the rotating sleeve and the rotating part; the rotating sleeve is provided with an angle ruler; The hollow screw sleeve is a hollow tubular structure; The lengthened hollow screw is sleeved in the hollow screw sleeve and is a hollow tubular structure, and the distal end is designed as a spiral blade or a thread.

2. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures according to claim 1, characterized in that: The upper surface of the track is a rack-shaped length scale; the slide seat is also provided with a housing sleeve, in which a rotating nut is installed, and the outer surface of the rotating nut is serrated and engages with the rack-shaped length scale of the track.

3. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures according to claim 1, characterized in that: One end of the rotating sleeve close to the rotating part is cylindrical and has saw teeth on the outer surface to form an angle ruler, and the second locking piece can be engaged and clamped with the saw teeth.

4. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures according to claim 3, characterized in that: The second locking member is also equipped with a wrench, which is used to lock the second locking member.

5. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures according to claim 1, characterized in that: A groove is provided on the inner wall of the second through hole of the rotating part, and a protrusion is provided on the outer wall of the hollow screw sleeve. The protrusion is inserted into the groove so that the hollow screw sleeve is fixed in the second through hole.

6. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures according to claim 1, characterized in that: A through hole with an internal thread is provided on the side wall of the blind hole. After the rotating part and the rotating sleeve are plugged in, the rotating part and the rotating sleeve are relatively fixed by screwing the screw into the through hole.

7. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures according to claim 1, characterized in that: The outer surface of the outer wall at the upper end of the lengthened hollow screw is a flat structure.

8. The integrated device for percutaneous minimally invasive extracorporeal reduction of vertebral fractures according to any one of claims 1 to 7, characterized in that: The first locking member and the second locking member are both self-locking buckles with springs. The first locking member is fixed on the slide and pressed against the track by the elastic force of the spring; the second locking member is fixed on the rotating part and pressed against the rotating sleeve by the elastic force of the spring.

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