A multifunctional vertebroplasty device

Abstract

The present invention discloses a multi-functional vertebroplasty device, which includes a balloon structure and a delivery tube structure. The delivery tube structure includes a shape memory alloy tube, a slider, and an outer tube adjusting handle. The shape memory alloy tube is sleeved outside the balloon outer tube and the balloon. The proximal end of the shape memory alloy tube is fixedly connected to the distal end of the slider. The proximal end of the slider is detachably connected to the balloon structure through a first lug. The outer surface of the slider is provided with a threaded structure, and the outer tube adjusting handle with an internal threaded structure is sleeved on the outer surface of the slider. By rotating the outer tube adjusting handle, the slider is driven to move back and forth, so as to control the protrusion amount of the distal end of the shape memory alloy tube relative to the distal end of the outer tube and the protrusion amount of the distal end of the balloon relative to the distal end of the shape memory alloy tube. The multi-functional vertebroplasty device provided by the present invention has a simple structure and is easy to operate. It integrates the vertebral canal expansion of the bone drill and the pre-expansion of the balloon catheter on one instrument, simplifies the surgical operation, shortens the surgical time, improves the surgical efficiency, and at the same time reduces the physical requirements of doctors and the economic burden of patients.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a multifunctional vertebroplasty device. Background Art

[0002] In the existing percutaneous kyphoplasty (PKP), a dilatable balloon is percutaneously inserted into a collapsed vertebra. The balloon is inflated to lift the endplate, restore the height of the vertebra, correct kyphotic deformity, and form a cavity surrounded by a bone shell within the vertebra. High-viscosity bone cement is then injected under low pressure. To smoothly insert the balloon into the vertebra, a working channel needs to be established using a puncture needle and a working cannula first. Then, a bone drill is used to drill a working cavity for the balloon before inflation. The balloon is then inserted into the vertebra. After a cavity surrounded by a bone shell is formed within the vertebra, the balloon is withdrawn, and finally, bone cement is injected. This operation procedure is cumbersome. Also, due to the structure of the vertebra, to maintain the biomechanical force balance of the vertebra, bilateral balloon dilation and bone cement injection are required for each vertebra. The operation needs to be performed under X-ray monitoring. The more cumbersome the operation process and the longer the time, the greater the damage to the doctor's health, and the higher the requirements for physical strength and operation level. Bilateral balloon dilation and bone cement injection cause great trauma to the patient, have a high chance of complications, and also increase the economic burden on the patient. These drawbacks become more prominent in the case of multi-segment vertebral lesions.

[0003] Patent CN109431589A discloses an integrated multifunctional vertebroplasty device, including a balloon assembly, a bending angle adjustment assembly, and a bending angle cavity opening assembly, but does not disclose in detail the connection relationship and working mode of each component at the proximal end to achieve multifunctionality.

[0004] Patent CN109745114A discloses a multifunctional vertebroplasty device, including a balloon assembly and a cavity opening assembly. The outer tube assembly in the cavity opening assembly includes an outer tube and an outer tube handle. The outer tube has a stiffness to withstand the tissue cavity opening thrust without deformation in the axial direction, and the outer tube handle is provided with a bone filler injection cavity interface. However, it does not disclose in detail the connection relationship and working mode of each component at the proximal end to achieve multifunctionality.

[0005] Therefore, it is an urgent problem to be solved to provide a vertebroplasty device with easy operation and simple structure to achieve the multifunctionality of the vertebroplasty device. Summary of the Invention

[0006] To solve the above-mentioned defects in the prior art, the present invention provides a vertebroplasty device with simple structure and easy operation, which integrates the vertebral expansion of the bone drill and the pre-expansion of the balloon catheter on one device, simplifies the surgical operation, shortens the surgical time, and improves the surgical efficiency. Since the operation needs to be performed under X-ray monitoring, shortening the surgical time helps to reduce the damage to the doctor's health and at the same time reduces the requirements for the doctor's physical strength and operation.

[0007] To achieve the above object, the present invention adopts the following technical solutions:

[0008] A multifunctional vertebroplasty device, comprising

[0009] A balloon structure, which includes a balloon outer tube, a balloon handle and a balloon; the proximal outer surface of the balloon outer tube is sequentially sleeved with a balloon handle fitting, the balloon handle and a balloon delivery buckle from inside to outside, and are fixedly connected to each other; wherein, the balloon handle and the balloon delivery buckle are rotatably fixed by a buckle; the balloon outer tube is fixedly connected to the distal end of the balloon, and the distal end of the balloon is sealed;

[0010] A delivery tube structure, including a shape memory alloy tube, a slider and an outer tube adjusting handle, the shape memory alloy tube is sleeved outside the balloon outer tube and the balloon, and the shape memory alloy tube is integrally injection-molded with the slider; the proximal end of the slider is detachably connected to the balloon delivery buckle through a first ear; the outer surface of the slider is provided with a threaded structure, and the outer tube adjusting handle with an internal threaded structure is sleeved on the outer surface of the slider, and by rotating the outer tube adjusting handle, the slider is driven to move back and forth, so as to control the protruding amount of the distal end of the shape memory alloy tube relative to the distal end of the outer tube and the protruding amount of the distal end of the balloon relative to the distal end of the shape memory alloy tube.

[0011] Preferably, the balloon structure further includes a balloon delivery buckle fitting, which is sleeved outside the balloon delivery buckle, the second ear at the distal end of the balloon delivery buckle is inserted into the chute on the inner surface of the balloon delivery buckle fitting, and a card slot is arranged at the distal end of the chute; the distal end of the balloon delivery buckle fitting is detachably connected to a limiting member sleeved outside the slider through a buckle; the inner circular edge at the distal end of the limiting member extends multiple non-connected arc-shaped parts along the outer surface of the slider towards the distal end direction, and the distal ends of the arc-shaped parts are fixed to the proximal end of the end cover through cylindrical pins, and the end cover is locked with the working sleeve handle through a locking ring; the outer tube adjusting handle is sleeved outside the arc-shaped part, and the threaded structure on the outer surface of the slider extends out of the gap of the arc-shaped part and cooperates with the internal threaded structure of the outer tube adjusting handle.

[0012] Furthermore, the locking ring is sleeved outside the distal end of the end cover, a top block is sleeved between the distal end of the end cover and the locking ring and is threadedly connected to the distal end of the end cover; the proximal end of the locking ring is fixed through the end cover and the top block, the proximal end of the locking ring can rotate around the end cover, and the distal end of the locking ring is fixedly connected to the working sleeve handle through a buckle.

[0013] Preferably, the outer tube is sleeved outside the shape memory alloy tube, and the outer tube is integrally injection-molded with the end cover.

[0014] The outer tube has a certain rigidity to assist the distal end of the vertebroplasty device to enter the specified position between vertebrae. When the distal end of the released shape memory alloy tube presents a certain bending angle and needs to be recovered into the working sleeve again, it can be first recovered into the outer tube.

[0015] Preferably, a protrusion extends from the proximal end of the balloon handle relative to the proximal ends of the balloon handle fitting and the balloon delivery buckle. The proximal end face of the protrusion is sealed to form a cavity, and a cavity interface is provided on the side wall of the protrusion; the balloon outer tube communicates with the outside through the protrusion.

[0016] Further, outside the proximal end face of the protrusion, a support wire seat is connected by threads. The support wire seat is fixedly connected to the proximal end of the support wire. The support wire is sequentially inserted into the hole on the proximal end face of the protrusion, the balloon outer tube and the balloon, and the distal end of the support wire contacts the distal end of the balloon.

[0017] The support wire is made of a plastic material. When the shape memory alloy tube presents a certain bending angle, a force is applied to the support wire to bend it, so that the distal end of the entire balloon structure is bent, and the bending angle is the same as that of the shape memory alloy tube.

[0018] Preferably, the part where the balloon inner tube contacts the balloon handle is bonded with a medical-grade glue; the part where the balloon handle fitting contacts the balloon handle is bonded with a medical-grade glue.

[0019] Preferably, a balloon inner tube is provided or not provided between the balloon outer tube and the support wire. The proximal end of the balloon inner tube is fixed in the hole on the proximal end face of the protrusion, and the distal end of the balloon inner tube contacts the distal end of the balloon.

[0020] Further, without the balloon inner tube, the balloon outer tube is directly inserted from the proximal end of the balloon to the distal end of the balloon. The proximal and distal ends of the balloon are both hot-melt welded or laser welded to the balloon outer tube; an opening is provided on the balloon outer tube inside the balloon; the inside of the balloon outer tube at the distal end of the balloon is sealed with UV glue or a PU rod.

[0021] Further, in an embodiment with a balloon inner tube, the distal end of the balloon inner tube is hot-melt welded or laser welded to the distal end of the balloon, and the inside of the balloon inner tube is sealed with UV glue, and the support wire contacts the UV glue.

[0022] Further, in an embodiment with a balloon inner tube, the distal end of the balloon is hot-melt welded or laser welded to the balloon inner tube through a transition tube; after the proximal end of the plug is laser welded to the distal end of the support wire, the proximal end face of the plug is adhesively sealed with the distal end face of the balloon using a medical-grade glue.

[0023] Preferably, a reinforcing tube is further sleeved on the outer surface of the balloon outer tube. The reinforcing tube is bonded to the balloon outer tube with medical-grade glue, and the reinforcing tube and the balloon handle fitting are integrally injection-molded.

[0024] The balloon outer tube is made of PU material and is relatively soft. The reinforcing tube has two functions: one is to protect the balloon outer tube, and the second is to make it easier to insert the balloon by utilizing the rigidity of the reinforcing tube.

[0025] Preferably, a bent portion is provided at the distal end of the shape memory alloy tube; in the initial state, the balloon is located inside the shape memory alloy tube. In this way, a certain sealing effect can be achieved on the distal end of the shape memory alloy tube to prevent cancellous bone inside the vertebral body from entering the shape memory alloy tube during the vertebral body expansion process. The vertebral body expansion is to establish a balloon channel by squeezing the cancellous bone inside the vertebral body with the head end of the shape memory alloy tube.

[0026] Adopting the above technical solutions, the present invention has the following technical effects compared with the prior art:

[0027] 1. The multifunctional vertebroplasty device of the present application organically combines the functions of vertebral body expansion with a bone drill, pre-expansion with a balloon catheter, and bone cement filling, reducing the number of surgical instruments, simplifying the surgical procedure, saving surgical time, and reducing the economic burden on patients;

[0028] 2. The shape memory alloy tube is conveyed by a threaded structure, with high adjustment precision and safer surgery;

[0029] 3. The shape memory alloy tube can directly reach the opposite side of the vertebral body from one side of the vertebral body puncture through the bending angle, reducing the surgical procedure and the pressure on the patient's body, enabling the vertebral body to complete vertebral body expansion (establishing a balloon channel), balloon pre-expansion (establishing a cavity for bone cement filling), and directly connecting with a bone cement injection kit to complete the bone cement injection operation with only one puncture, which is simple and convenient to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a schematic structural diagram of a multifunctional vertebroplasty device of the present invention;

[0031] Figure 2a is a first-angle cross-sectional view of the structure of a multifunctional vertebroplasty device of the present invention;

[0032] Figure 2b is Figure 2a a schematic structural diagram of the area A in

[0033] Figure 3a is a second-angle cross-sectional view of the structure of a multifunctional vertebroplasty device of the present invention;

[0034] Figure 3b For Figure 3a Schematic diagram of the structure of area B in

[0035] Figure 4 Cross-sectional view of the relative positional relationship of each component at the proximal end of a multifunctional vertebroplasty device of the present invention;

[0036] Figure 5 Schematic diagram of the connection between the balloon delivery buckle and the slider of a multifunctional vertebroplasty device of the present invention;

[0037] Figure 6 Schematic diagram of the structure of the slider of a multifunctional vertebroplasty device of the present invention;

[0038] Figure 7 Schematic diagram of the structure after inserting a multifunctional vertebroplasty device into the working cannula of the present invention;

[0039] Figure 8a Schematic diagram of the position of the buckle before balloon pre-expansion of a multifunctional vertebroplasty device of the present invention;

[0040] Figure 8b Schematic diagram of the position of the buckle after balloon pre-expansion of a multifunctional vertebroplasty device of the present invention;

[0041] Figure 9 Schematic diagram of the balloon delivery buckle fitting of a multifunctional vertebroplasty device of the present invention;

[0042] Figure 10a Schematic diagram of the working mode of establishing a balloon channel in Example 2 of a multifunctional vertebroplasty device of the present invention;

[0043] Figure 10b Schematic diagram of the second working mode of establishing a balloon channel in Example 3 of a multifunctional vertebroplasty device of the present invention;

[0044] Figure 11a Schematic diagram of the working mode of realizing balloon pre-expansion in Example 2 of a multifunctional vertebroplasty device of the present invention;

[0045] Figure 11b Schematic diagram of the working mode of realizing balloon pre-expansion in Example 3 of a multifunctional vertebroplasty device of the present invention;

[0046] Figure 12a Schematic diagram of the working mode of pulling out the balloon structure in Example 2 of a multifunctional vertebroplasty device of the present invention;

[0047] Figure 12b Schematic diagram of the working mode of pulling out the balloon structure in Example 3 of a multifunctional vertebroplasty device of the present invention;

[0048] Figure 13aCross-sectional view of the relative position of the front balloon delivery buckle and the limiting member before the extraction balloon structure of a multifunctional vertebroplasty device according to the present invention;

[0049] Figure 13b Cross-sectional view of the relative position of the rear balloon delivery buckle and the limiting member after the extraction balloon structure of a multifunctional vertebroplasty device according to the present invention;

[0050] Figure 14 Schematic diagram of the balloon structure of a multifunctional vertebroplasty device according to the present invention;

[0051] Figure 15 Schematic diagram of the structure after the extraction balloon structure of a multifunctional vertebroplasty device according to the present invention;

[0052] Figure 16a Schematic diagram of the first treatment form of the distal end of the balloon of a multifunctional vertebroplasty device according to the present invention;

[0053] Figure 16b Schematic diagram of the second treatment form of the distal end of the balloon of a multifunctional vertebroplasty device according to the present invention;

[0054] Figure 16c Schematic diagram of the third treatment form of the distal end of the balloon of a multifunctional vertebroplasty device according to the present invention;

[0055] Figure 16d Schematic diagram of the fourth treatment form of the distal end of the balloon of a multifunctional vertebroplasty device according to the present invention;

[0056] Figure 16e Schematic diagram of the fifth treatment form of the distal end of the balloon of a multifunctional vertebroplasty device according to the present invention;

[0057] Figure 16f Schematic diagram of the sixth treatment form of the distal end of the balloon of a multifunctional vertebroplasty device according to the present invention;

[0058] Figure 17 Schematic diagram of the end cap structure of a multifunctional vertebroplasty device according to the present invention;

[0059] Explanation of the markings in the figure:

[0060] 1 - Balloon structure, 11 - Balloon handle, 111 - Protrusion, 112 - Cavity interface, 113 - Support wire seat, 114 - Channel, 12 - Balloon handle fitting, 121 - Reinforcing tube, 13 - Balloon delivery buckle, 131 - Second ear, 132 - Fourth ear, 14 - Balloon delivery buckle fitting, 141 - Slide groove, 142 - Card slot, 143 - Third ear, 15 - Balloon, 151 - Plug, 152 - Transition tube, 153 - UV glue, 154 - PU rod, 16 - Balloon outer tube, 161 - Outer tube opening, 17 - Balloon inner tube, 18 - Support wire

[0061] 2 - Delivery tube structure, 21 - Shape memory alloy tube, 22 - Outer tube adjustment handle, 23 - Slide block, 231 - First ear, 24 - Limiting member, 241 - Limiting card slot, 242 - Arc portion, 25 - End cap, 251 - Cylindrical pin, 26 - Locking ring, 261 - Top block, 27 - Bending portion, 28 - Outer tube

[0062] 3 - Working sleeve structure, 31 - Working sleeve handle, 32 - Working sleeve Detailed implementation mode

[0063] The present invention will be introduced in detail and specifically through specific embodiments to better understand the present invention. However, the following embodiments do not limit the scope of the present invention.

[0064] In the following embodiments, the proximal end represents the direction close to the operator, and the distal end represents the direction close to the patient; clockwise is the clockwise direction relative to the operator, and counterclockwise is the counterclockwise direction relative to the operator.

[0065] Embodiment 1

[0066] This embodiment provides a multifunctional vertebroplasty device, as shown in Figure 1 , 2a -2b and 3a - 3b, which includes

[0067] A balloon structure 1, which includes a balloon outer tube 16, a balloon handle 11 and a balloon 15; the proximal outer surface of the balloon outer tube 16 is sequentially sleeved with a balloon handle fitting 12, the balloon handle 11, and a balloon delivery buckle 13 from the inside to the outside; wherein, the balloon handle 11 and the balloon delivery buckle 13 are rotatably fixed by the cooperation of the fourth ear 132 on the balloon delivery buckle 13 and the card slot on the balloon handle 11; the balloon handle fitting 12 is fixedly connected to the balloon handle 11; the distal end of the balloon outer tube 16 is fixedly connected to the balloon 15, and the distal end of the balloon 15 is sealed.

[0068] A delivery tube structure 2, including a shape memory alloy tube 21, a slide block 23 and an outer tube adjustment handle 22, the shape memory alloy tube 21 is sleeved outside the balloon outer tube 16 and the balloon 15, and the shape memory alloy tube 21 is integrally injection molded with the slide block 23; the proximal end of the slide block 23 is detachably connected to the balloon delivery buckle 13 through the first ear 231; the outer surface of the slide block 23 is provided with a threaded structure, and the outer tube adjustment handle 22 with an internal threaded structure is sleeved on the outer surface of the slide block 23. By rotating the outer tube adjustment handle 22, the slide block 23 is driven to move back and forth, so as to control the protrusion amount of the distal end of the shape memory alloy tube 21 relative to the distal end of the outer tube 28 and the protrusion amount of the distal end of the balloon 15 relative to the distal end of the shape memory alloy tube 21.

[0069] In this embodiment, as shown in Figures 2a - 2b Figures 3a - 3b, the balloon structure 1 further includes a balloon delivery buckle fitting 14, which is sleeved outside the balloon delivery buckle 13. The second lug 131 at the distal end of the balloon delivery buckle 13 is inserted into the chute 141 on the inner surface of the balloon delivery buckle fitting 14, and a card slot 142 is provided at the distal end of the chute 141. The distal end of the balloon delivery buckle fitting 14 is detachably connected to a limiting member 24 sleeved outside the slider 23 through a buckle. The inner circular edge at the distal end of the limiting member 24 extends a plurality of non - connected arc - shaped portions 242 along the outer surface of the slider 23 towards the distal end. The distal ends of the arc - shaped portions 242 are fixed to the proximal end of the end cap 25 through a cylindrical pin 251. The end cap 25 is locked with the working sleeve handle 31 through a locking ring 26. The outer tube adjusting handle 22 is sleeved outside the arc - shaped portions 242, and the threaded structure on the outer surface of the slider 23 extends out of the gap of the arc - shaped portions 242 and cooperates with the internal threaded structure of the outer tube adjusting handle 22.

[0070] In this embodiment, the locking ring 26 is sleeved outside the distal end of the end cap 25. A top block 261 is sleeved between the distal end of the end cap 25 and the locking ring 26 and is threadedly connected to the distal end of the end cap 25. The proximal end of the locking ring 26 is fixed through the end cap 25 and the top block 261. The proximal end of the locking ring 26 can rotate around the end cap 25, and the distal end of the locking ring 26 is fixed in cooperation with the working sleeve handle 31 through a buckle.

[0071] In this embodiment, as shown in Figure 1 Figures 17 ..., the outer tube 28 is sleeved outside the shape - memory alloy tube 21, and the outer tube 28 is integrally injection - molded with the end cap 25. The outer tube 28 has a certain rigidity to assist the distal end of the vertebral body forming device to enter the specified position between vertebrae. When the distal end of the released shape - memory alloy tube 21 presents a certain bending angle and needs to be recovered into the working sleeve 32 again, it can be first recovered into the outer tube 28.

[0072] In this embodiment, as shown in Figure 4 Figure..., a protruding portion 111 extends from the proximal end of the balloon handle 11 relative to the proximal ends of the balloon handle fitting 12 and the balloon delivery buckle 13. The proximal end surface of the protruding portion 111 is sealed to form a cavity, and a cavity interface 112 is provided on the side wall of the protruding portion 111. The balloon outer tube 16 is communicated with the outside through the protruding portion 111.

[0073] In this embodiment, as shown in Figure 2a Figures 3aAmong 4, 16a - 16f, outside the proximal end face of the protrusion 111, a support wire seat 113 is connected by thread. The support wire seat 113 is fixedly connected to the proximal end of the support wire 18. The support wire 118 is sequentially inserted into the pore channel 114 on the proximal end face of the protrusion 111, the balloon outer tube 16, and the balloon 15. Finally, the distal end face of the support wire 18 contacts the distal end of the balloon 15. When there is no plug 151 welded to the distal end of the support wire 18, the support wire seat 113 can be rotated to separate from the support seat, and then the entire support wire 18 can be withdrawn.

[0074] In an embodiment of the present invention, Figure 10b Among them, a bent portion 27 is provided at the distal end of the shape memory alloy tube 21. In the initial state, the balloon 15 is located inside the shape memory alloy tube 21, which can play a certain sealing role at the distal end of the shape memory alloy tube 21 to prevent the cancellous bone inside the vertebral body from entering the shape memory alloy tube 21 during the process of vertebral body expansion. The vertebral body expansion is to establish a balloon channel by squeezing the cancellous bone inside the vertebral body with the head end of the shape memory alloy tube. Preferably, the shape memory alloy tube itself is a memory metal. Through the shaping angle designed on the shaping die, the shape memory alloy tube can present a 90° bend angle after heat treatment. The purpose of heat treatment of the shape memory alloy tube is to reduce its Af point (the temperature when returning to the bent angle state) to obtain superelasticity. Therefore, after the shape memory alloy tube extends out of the outer tube, it can automatically return to the bent angle state by using its own memory performance and the superelasticity after heat treatment. Further, in this embodiment, the Af point of the shape memory alloy tube is controlled at about 20°C after heat treatment shaping. When the temperature is higher than the Af point, the shape memory alloy tube can quickly return to the bent angle state. When establishing the balloon channel, the shape memory alloy tube enters the vertebral body. The temperature inside the human body is about 37°C. Therefore, when the shape memory alloy tube comes out of the sleeve, it will establish a balloon channel in the vertebral body in the shaped bent angle state. Thus, the shape memory alloy tube can directly reach the opposite side of the vertebral body from one side of the vertebral puncture through the bent portion.

[0075] In this embodiment, the support wire 18 is made of semi - rigid material, providing sufficient rigidity to the distal end of the balloon structure 1 so that it can enter between the vertebral bodies. There is a bent portion 27 at the distal end of the shape memory alloy tube 21 as Figure 10b shown. When the shape memory alloy tube 21 presents a certain bending angle, a force is applied to the support wire 18 to make it bend, so that the distal end of the entire balloon structure 1 becomes bent, and the bending angle is the same as that of the shape memory alloy tube 21 as Figure 11b shown.

[0076] In this embodiment, as Figure 4 、 16aIn - 16f, a reinforcing tube 121 is also sleeved on the outer surface of the balloon outer tube 16. The reinforcing tube 121 is bonded to the balloon outer tube 16 with medical - grade glue, and the reinforcing tube 121 and the balloon handle fitting 12 are integrally injection - molded.

[0077] In this embodiment, as Figure 16a described, the distal end of the balloon outer tube 16 is hot - melt welded or laser - welded to the proximal end of the balloon 15; the distal end of the balloon 15 is sealed with UV glue 153.

[0078] In an embodiment of the present invention, as Figure 16b described, the distal end of the balloon outer tube 16 is hot - melt welded or laser - welded to the proximal end of the balloon 15; the distal end of the balloon 15 is hot - melt welded or laser - welded and sealed with the balloon through a PU rod 154.

[0079] In an embodiment of the present invention, as Figure 16c described, the balloon outer tube 16 is directly inserted from the proximal end of the balloon 15 to the distal end of the balloon 15. Both the proximal end and the distal end of the balloon 15 are hot - melt welded or laser - welded to the balloon outer tube 16. An outer tube opening 161 is provided on the balloon outer tube 16 inside the balloon 15; UV glue 153 is applied at a point inside the balloon outer tube 16 at the distal end of the balloon for sealing.

[0080] In an embodiment of the present invention, as Figure 16d described, the balloon outer tube 16 is directly inserted from the proximal end of the balloon 15 to the distal end of the balloon 15. Both the proximal end and the distal end of the balloon 15 are hot - melt welded or laser - welded to the balloon outer tube 16. An outer tube opening 161 is provided on the balloon outer tube 16 inside the balloon 15; the balloon outer tube 16 at the distal end of the balloon is hot - melt welded or laser - welded and sealed with the balloon through a PU rod 154.

[0081] In an embodiment of the present invention, as Figures 16e - 16f described, the distal end of the balloon outer tube 16 is hot - melt welded or laser - welded to the proximal end of the balloon 15. There is also a balloon inner tube 17 between the balloon outer tube 16 and the support wire 18. The proximal end of the balloon inner tube 17 is fixed in the channel 114 on the proximal - face of the protrusion 111, and the distal end of the balloon inner tube 17 is fixedly connected to the distal end of the balloon 15.

[0082] In an embodiment of the present invention, as Figure 16e described, the distal end of the balloon 15 is hot - melt welded or laser - welded to the balloon inner tube 17 through a transition tube 152; the balloon inner tube 17 is sealed with UV glue 153, and the distal end of the support wire 18 abuts against the UV glue 153.

[0083] In an embodiment of the present invention, asFigure 16f In this case, the distal end of the balloon 15 and the inner tube 17 of the balloon are heat-sealed or laser-welded through a transition tube 152; after the proximal end of the plug 151 and the distal end of the support wire 18 are laser-welded, the proximal end face of the plug 151 and the distal end face of the balloon 15 are adhesively sealed with medical-grade glue.

[0084] Embodiment 2

[0085] In this embodiment, the working principle of the multifunctional vertebroplasty device described in Embodiment 1 is provided.

[0086] (1) Before the operation starts, as Figure 2a 、 3a 、5, 14 - 15 show, connect the delivery tube structure 2 to the outside of the balloon structure 1 through a buckle. The first ear 231 on the slider 23 is clamped in the card slot at the distal end of the balloon delivery buckle 13, and the third ear 143 on the balloon delivery buckle fitting 14 is clamped in the limit card slot 241 on the limiting member 24; as Figure 1 and Figure 5 show, after establishing the working channel, insert the multifunctional vertebroplasty device provided in Embodiment 1 into the working sleeve structure 3, and rotate the locking ring 26 to fix the multifunctional vertebroplasty device to the working sleeve handle 31 on the working sleeve structure 3;

[0087] (2) As Figure 10a shows, rotate the outer tube adjustment handle 22 clockwise. Through the threaded drive between the outer tube adjustment handle 22 and the slider 23, drive the balloon structure 1 and the slider 23 to move forward, so that the balloon 15 follows the shape memory alloy tube 21 and extends into the vertebral body until the shape memory alloy tube 21 extends to the preset position to expand the vertebra and establish a balloon channel; as Figure 9 shows, after the balloon channel is established, the second ear 131 on the balloon delivery buckle 13 is located at the bottom of the chute 141 of the balloon delivery buckle fitting 14;

[0088] (3) As Figures 8a - 8b 、 Figure 9 、 Figure 11a shows, rotate the balloon delivery buckle 13 counterclockwise to completely release the restriction of the first ear 231 on the slider 23 from the card slot at the distal end of the balloon delivery buckle 13, so that the slider 23 is completely released from the restriction of the balloon delivery buckle 13, and screw the second ear 131 into the card slot 142 at the bottom of the chute 141 of the balloon delivery buckle fitting 14; then rotate the outer tube adjustment handle 22 counterclockwise to retract the shape memory alloy tube 21 back into the outer tube 28. Thus, the balloon 15 is completely placed in the established balloon channel;

[0089] (4) Connect to a pressure pump through the cavity interface 112 on the balloon handle 11, inject contrast agent into the balloon 15, reduce the fractured vertebra and create a cavity filled with bone cement to achieve unilateral balloon pre-expansion; after the unilateral balloon pre-expansion is completed, withdraw the contrast agent injected into the balloon 15 through the pressure pump;

[0090] (5) Then use the same another set of surgical device to achieve balloon pre-expansion on the other side of the vertebra by puncturing the other side of the vertebra. After the balloon pre-expansion is completed, withdraw the contrast agent injected into the balloon 15 through the pressure pump;

[0091] (6) As Figures 13a - 13b and shown in 12a, at this time, rotate the balloon delivery buckle fitting 14 clockwise to disengage the two third lugs 143 on the balloon delivery buckle fitting 14 from the restriction of the stopper 24, and then pull out the balloon structure as shown in Figure 14 ;

[0092] (7) Connect the bone cement injection kit to the joint on the slider 23 in the structure as shown in Figure 15 , inject bone cement into the established bone cement filling cavity, and finally withdraw the working sleeve to complete the operation.

[0093] Embodiment 3

[0094] This embodiment provides the working principle of the multifunctional vertebroplasty device described in Embodiment 1.

[0095] (1) Before the operation starts, as shown in Figure 2a , 3a , 5, 14 - 15, connect the delivery tube structure 2 to the outside of the balloon structure 1 through a buckle. The first lug 231 on the slider 23 is clamped in the slot at the distal end of the balloon delivery buckle 13, and the third lug 143 on the balloon delivery buckle fitting 14 is clamped in the limit slot 241 on the stopper 24; as shown in Figure 1 and Figure 5 , after establishing the working channel, insert the multifunctional vertebroplasty device provided in Embodiment 1 into the working sleeve structure 3, and rotate the locking ring 26 to fix the multifunctional vertebroplasty device to the working sleeve handle 31 on the working sleeve structure 3;

[0096] (2) As shown in Figure 10b , rotate the outer tube adjustment handle 22 clockwise. Drive the balloon structure 1 and the slider 23 to move forward through the threaded structure transmission between the outer tube adjustment handle 22 and the slider 23, so that the balloon 15 follows the shape memory alloy tube 21 and extends into the vertebra until the shape memory alloy tube 21 extends to the preset position to achieve vertebral expansion and establish a balloon channel. The shape memory alloy tube 21 can directly puncture from one side of the vertebra to the other side of the vertebra through the bending part 27; as shown in Figure 9As shown, after the balloon channel is established, the second lug 131 on the balloon delivery buckle 13 is located at the bottom of the chute 141 of the balloon delivery buckle fitting 14;

[0097] (3) As shown in Figures 8a - 8b , Figure 9 , Figure 11b Rotate the balloon delivery buckle 13 counterclockwise so that the first lug 231 on the slider 23 is completely released from the restriction of the distal slot of the balloon delivery buckle 13, so that the slider 23 is completely released from the restriction of the balloon delivery buckle 13, and rotate the second lug 131 into the slot 142 at the bottom of the chute 141 of the balloon delivery buckle fitting 14. At this time, the balloon delivery buckle 13 is locked with the balloon delivery buckle fitting 14; then rotate the outer tube adjustment handle 22 counterclockwise to withdraw the shape memory alloy tube 21 into the outer tube 28. Thus, the balloon 15 is completely placed in the established balloon channel;

[0098] (4) Connect to the pressure pump through the cavity interface 112 on the balloon handle 11, inject contrast agent into the balloon 15, reduce the compressed fractured vertebra and create a cavity filled with bone cement to achieve unilateral balloon pre-expansion; after the unilateral balloon pre-expansion is completed, withdraw the contrast agent injected into the balloon 15 through the pressure pump;

[0099] (5) As shown in Figure 12b and 13a -13b, rotate the balloon delivery buckle fitting 14 clockwise at this time so that the two third lugs 143 on the balloon delivery buckle fitting 14 are released from the restriction of the stopper 24, and then pull out the balloon structure as shown in Figure 14 ;

[0100] (6) Connect the bone cement injection kit to the joint on the slider 23 in the structure as shown in Figure 15 , inject bone cement into the established bone cement-filled cavity, and finally withdraw the working sleeve to complete the operation.

[0101] The specific embodiments of the present invention have been described in detail above, but they are only examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions made to the present invention are also within the scope of the present invention. Therefore, equivalent transformations and modifications made without departing from the spirit and scope of the present invention should all be covered within the scope of the present invention.

Claims

1. A multifunctional vertebroplasty device, characterized in that, it comprises a balloon structure (1), which includes a balloon outer tube (16), a balloon handle (11) and a balloon (15); on the outer surface of the proximal end of the balloon outer tube (16), a balloon handle fitting (12), the balloon handle (11), and a balloon delivery buckle (13) are sequentially sleeved from the inside to the outside; wherein, the balloon handle (11) and the balloon delivery buckle (13) are rotatably and fixedly connected by a buckle, and the balloon handle fitting (12) is fixedly connected to the balloon handle (11); the distal end of the balloon outer tube (16) is fixedly connected to the balloon (15), and the distal end of the balloon (15) is sealed; a delivery tube structure (2), which includes a shape memory alloy tube (21), a slider (23) and an outer tube adjusting handle (22), the shape memory alloy tube (21) is sleeved outside the balloon outer tube (16) and the balloon (15), and the shape memory alloy tube (21) and the slider (23) are integrally injection molded; the proximal end of the slider (23) is detachably connected to the balloon delivery buckle (13) through a first lug (231); the outer surface of the slider (23) is provided with a threaded structure, and the outer tube adjusting handle (22) with an internal threaded structure is sleeved on the outer surface of the slider (23), and by rotating the outer tube adjusting handle (22), the slider (23) is driven to move back and forth, so as to control the protruding amount of the distal end of the shape memory alloy tube (21) relative to the distal end of the outer tube (28) and the protruding amount of the distal end of the balloon (15) relative to the distal end of the shape memory alloy tube (21); the balloon structure (1) further includes a balloon delivery buckle fitting (14), which is sleeved outside the balloon delivery buckle (13), the second lug (131) at the distal end of the balloon delivery buckle (13) is inserted into the chute (141) on the inner surface of the balloon delivery buckle fitting (14), and a card slot (142) is arranged at the distal end of the chute (141); the distal end of the balloon delivery buckle fitting (14) is detachably connected to a limiting member (24) sleeved outside the slider (23) through a buckle; the inner circular edge at the distal end of the limiting member (24) extends a plurality of non-connected arc-shaped parts (242) along the outer surface of the slider (23) towards the distal end direction, and the distal ends of the arc-shaped parts (242) are fixed to the proximal end of an end cap (25) through a cylindrical pin (251), and the end cap (25) is locked with a working sleeve handle (31) through a locking ring (26); the outer tube adjusting handle (22) is sleeved outside the arc-shaped parts (242), and the threaded structure on the outer surface of the slider (23) extends out of the gap of the arc-shaped parts (242) and cooperates with the internal threaded structure of the outer tube adjusting handle (22); The outer tube (28) is sleeved outside the shape memory alloy tube (21), and the outer tube (28) and the end cap (25) are integrally injection-molded; a top block (261) is sleeved between the distal end of the end cap (25) and the locking ring (26), and is threadedly connected to the distal end of the end cap (25); the proximal end of the locking ring (26) is fixed by the end cap (25) and the top block (261), the proximal end of the locking ring (26) can rotate around the end cap (25), and the distal end of the locking ring (26) is fixed in cooperation with the working sleeve handle (31) through a buckle.

2. The multifunctional vertebroplasty device according to claim 1, wherein, a protruding portion (111) extends from the proximal end of the balloon handle (11) relative to the proximal ends of the balloon handle fitting (12) and the balloon delivery buckle (13), the proximal end face of the protruding portion (111) is sealed to form a cavity, and a cavity interface (112) is provided on the side wall of the protruding portion (111); the balloon outer tube (16) communicates with the outside through the protruding portion (111).

3. The multifunctional vertebroplasty device according to claim 2, wherein, a support wire seat (113) is threadedly connected to the outside of the proximal end face of the protruding portion (111), the support wire seat (113) is fixedly connected to the proximal end of the support wire (18), the support wire (18) is sequentially inserted into the hole (114) on the proximal end face of the protruding portion (111), the balloon outer tube (16) and the balloon (15), and finally the distal end face of the support wire (18) contacts the distal end of the balloon (15).

4. The multifunctional vertebroplasty device according to claim 3, wherein, a balloon inner tube (17) is provided or not provided between the balloon outer tube (16) and the support wire (18), the proximal end of the balloon inner tube (17) is fixed in the hole (114) on the proximal end face of the protruding portion (111), and the distal end of the balloon inner tube (17) is fixedly connected to the distal end of the balloon (15).

5. The multifunctional vertebroplasty device according to claim 4, wherein, without the balloon inner tube (17), the balloon outer tube (16) is directly inserted from the proximal end of the balloon (15) to the distal end of the balloon (15), and both the proximal and distal ends of the balloon (15) are heat-sealed or laser-welded to the balloon outer tube (16); an outer tube opening (161) is provided on the balloon outer tube (16) inside the balloon (15); the inside of the balloon outer tube (16) at the distal end of the balloon (15) is sealed with UV glue (153) or a PU rod (154).

6. The multifunctional vertebroplasty device according to claim 4, wherein, A balloon inner tube (17) is provided. The distal end of the balloon (15) and the balloon inner tube (17) are joined by hot melt welding or laser welding through a transition tube (152). After the proximal end of the plug (151) and the distal end of the support wire (18) are joined by laser welding, the proximal end face of the plug (151) and the distal end face of the balloon (15) are adhesively sealed with a medical-grade glue.

7. The multifunctional vertebroplasty device according to claim 1, characterized in that a reinforcing tube (121) is further sleeved on the outer surface of the balloon outer tube (16). The reinforcing tube (121) and the balloon outer tube (16) are adhesively joined with a medical-grade glue, and the reinforcing tube (121) and the balloon handle fitting (12) are integrally injection molded.

8. The multifunctional vertebroplasty device according to claim 1, characterized in that a bent portion (27) is provided at the distal end of the shape memory alloy tube (21).

Images