A double-balloon vertebroplasty implant device

Abstract

The present invention relates to a double-balloon vertebroplasty implant device, comprising: an inner delivery assembly, an outer delivery assembly, and an outer tube assembly; a double-balloon vertebroplasty implant device of the present invention includes an inner balloon and an outer balloon. The inner balloon is not provided with micropores, and the outer balloon is provided with micropores. After the device establishes a cavity, bone filler is first injected into the inner balloon to expand the inner balloon in the vertebral body to reach the required height, which is beneficial to maintaining the mechanical structure inside the vertebral body; then bone filler is injected into the outer balloon, so that part of the bone filler oozes out from the micropores of the outer balloon, achieving a better riveting effect between the balloon and the vertebral body; the fixed bending angle part at the distal end of the outer tube is pre-installed in the adjustment tube, enabling the device to pass through the working channel straight, so that the operator does not need to laboriously place the device into the working channel, and the release and recovery of the fixed bending angle part at the distal end of the outer tube are realized by operating the adjustment tube handle.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a double-balloon vertebroplasty implant device. Background Art

[0002] Currently, percutaneous vertebroplasty (PVP) and balloon kyphoplasty (PKP) are generally used in the treatment of osteoporotic vertebral compression fractures. Due to the structure of the vertebra, in order to maintain the mechanical balance of the vertebra, the existing balloon kyphoplasty usually requires bilateral balloon dilation for each vertebra. And during the balloon dilation process, the original cracks in the vertebra are often enlarged, and the bone cement will leak along these cracks into the surrounding bone tissue or even outside the vertebra, causing serious complications, greater damage to the patient, and slow postoperative recovery. At the same time, after the balloon is withdrawn from the vertebra, the height originally expanded by the balloon will be lost to a certain extent, reducing the ability to correct kyphosis. Currently, there is a bone filler implantation system, which although solves the problem of large trauma caused by bilateral punctures in common PKP surgeries and reduces the risk of bone filler leakage outside the vertebra, however, the limitation of the micropores on the sac and the limitation of the sac shape determine the distribution of the amount of bone cement released into the vertebra. At the same time, more micropores reduce the pressure that the sac can withstand when expanding, resulting in insufficient height of the sac expansion, and there are still certain problems with maintaining the mechanical structure inside the vertebra for this bone filler implantation system.

[0003] Therefore, there is an urgent need for a double-balloon vertebroplasty implant device that implants an expandable sac into the center of the vertebra through a delivery device with a curved section at the distal end, injects bone filler into the sac through the delivery device, so as to achieve the purpose of restoring the vertebral height and avoiding bone filler leakage, not only reducing the problem of large trauma caused by bilateral punctures in common PKP surgeries and reducing the risk of bone filler leakage outside the vertebra, but also being able to effectively compress cancellous bone, and having a better effect on maintaining the internal mechanical structure after vertebroplasty. Summary of the Invention

[0004] The purpose of the present invention is to provide a double-balloon vertebroplasty implant device for the deficiencies in the prior art.

[0005] To achieve the above purpose, the technical solution adopted by the present invention is:

[0006] Provide a double-balloon vertebroplasty implant device, including: an inner delivery assembly, an outer delivery assembly, and an outer tube assembly;

[0007] The inner delivery assembly includes an inner balloon, an inner balloon connecting tube, an inner balloon pressing tube, and an inner balloon handle; the inner balloon, after being formed, is cylindrical, dumbbell-shaped, or multi-protrusion-shaped and has no micropores thereon, and a distal closed inner balloon head is fixedly provided at the distal end; the proximal end of the inner balloon head has a blind hole with an opening facing the inside of the inner balloon; the proximal end of the inner balloon is detachably connected to the distal end of the inner balloon connecting tube through the inner balloon pressing tube; the inner balloon handle includes an inner balloon connecting tube handle and an inner balloon pressing tube handle; by operating the inner balloon handle to cause relative movement between the inner balloon connecting tube handle and the inner balloon pressing tube handle, the disassembly of the inner balloon can be achieved; an inner balloon injection port is provided on the inner balloon pressing tube handle;

[0008] The outer delivery assembly includes an outer balloon, an outer balloon connecting tube, an outer balloon pressing tube, and an outer balloon handle; the outer balloon, after being formed, is cylindrical, dumbbell-shaped, or multi-protrusion-shaped and has micropores thereon, and a distal closed outer balloon head is fixedly provided at the distal end; the proximal end of the outer balloon head has a blind hole with an opening facing the inside of the outer balloon; the proximal end of the outer balloon is detachably connected to the distal end of the outer balloon connecting tube through the outer balloon pressing tube; the outer balloon handle includes an outer balloon connecting tube handle and an outer balloon pressing tube handle; by operating the outer balloon handle to cause relative movement between the outer balloon connecting tube handle and the outer balloon pressing tube handle, the disassembly of the outer balloon can be achieved; an outer balloon injection port is provided on the outer balloon connecting tube handle;

[0009] The outer tube assembly includes an outer tube and an outer tube handle connected to the proximal end of the outer tube; the proximal part of the outer tube is a rigid section, and the distal part is a flexible section, and the flexible section is rigid in the radial direction;

[0010] Wherein, the distal end of the inner balloon head is sleeved and abutted against the blind hole of the outer balloon head; the inner balloon pressing tube handle is hermetically connected to the outer balloon connecting tube handle; the outer tube is sleeved outside the outer balloon pressing tube and the outer balloon;

[0011] During the operation, under fluoroscopic observation, the double-balloon vertebroplasty implant device enters the target vertebra through the working channel. After reaching the contralateral side of the target vertebra, the outer tube handle is operated, and the outer tube axially moves proximally towards the outer balloon pressing tube, exposing the balloon body. The inner balloon is opened through the inner delivery assembly, and the outer balloon is opened through the outer delivery assembly.

[0012] Preferably, the inner balloon is made of a medical polymer material.

[0013] Preferably, the distal end of the inner balloon connecting tube and / or the distal end of the inner balloon pressing tube are processed by deformation, so that when the distal ends of the inner balloon connecting tube and the inner balloon pressing tube are coaxially assembled, a line or surface contact is formed, thereby fixing the proximal end of the inner balloon between the inner balloon connecting tube and the inner balloon pressing tube.

[0014] More preferably, the deformation treatment includes flaring, necking, steps, fixing protrusions or expanding the inner cavity.

[0015] Preferably, the outer balloon is made of a medical polymer material.

[0016] Preferably, the distal end of the outer balloon connecting tube and / or the distal end of the outer balloon pressing tube are processed by deformation, so that when the distal ends of the outer balloon connecting tube and the outer balloon pressing tube are coaxially assembled, a line or surface contact is formed, thereby fixing the proximal end of the outer balloon between the outer balloon connecting tube and the outer balloon pressing tube.

[0017] More preferably, the deformation treatment includes flaring, necking, steps, fixing protrusions or expanding the inner cavity.

[0018] Preferably, the flexible section of the outer tube is formed in the following ways: formed by cutting a metal tube, made of a shape memory alloy, made of a spring, made of a medical polymer material, or composed of a combination of a metal material and a polymer material.

[0019] Preferably, it further includes: a liner core assembly;

[0020] The liner core assembly includes a liner core and a liner core handle; the liner core is slidably inserted into the inner balloon connecting tube and abuts against the blind hole of the inner balloon head; the liner core handle is arranged at the proximal end of the liner core.

[0021] More preferably, the outer tube and / or the liner core axially have a stiffness that can withstand the thrust of tissue cavity opening without deformation.

[0022] Preferably, it further includes: a bend angle adjustment assembly;

[0023] The bend angle adjustment assembly includes an adjustment handle and an adjustment tube; the adjustment handle is arranged at the proximal end of the adjustment tube; the distal curved section parts of the inner delivery assembly, the outer delivery assembly and the outer tube assembly are pre-installed in the adjustment tube, and the release and recovery of the curved section parts are realized by operating the adjustment handle.

[0024] The present invention adopts the above technical solutions, and compared with the prior art, has the following technical effects:

[0025] A double-balloon vertebroplasty implant device of the present invention includes an inner balloon and an outer balloon. The inner balloon is not provided with micropores, and the outer balloon is provided with micropores. After the device establishes a cavity, bone filler is first injected into the inner balloon to expand the inner balloon in the vertebral body to reach the required height, which is beneficial to maintaining the mechanical structure inside the vertebral body. Then, bone filler is injected into the outer balloon, so that part of the bone filler oozes out from the micropores of the outer balloon, achieving a better riveting effect between the balloon and the vertebral body. The fixed bending part at the distal end of the outer tube is pre-installed in the adjustment tube, enabling the device to pass through the working channel straight, so that the operator does not need to laboriously put the device into the working channel, and the release and recovery of the fixed bending part at the distal end of the outer tube are realized by operating the adjustment tube handle. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a schematic structural diagram of a double-balloon vertebroplasty implant device of the present invention;

[0027] Figure 2 is a schematic structural diagram of a double-balloon vertebroplasty implant device of the present invention;

[0028] Figure 3 is a schematic structural diagram of a double-balloon vertebroplasty implant device of the present invention;

[0029] Figure 4 is a schematic structural diagram of an inner delivery assembly of a double-balloon vertebroplasty implant device of the present invention;

[0030] Figure 5 is a schematic structural diagram of an inner delivery assembly of a double-balloon vertebroplasty implant device of the present invention;

[0031] Figure 6 is a schematic structural diagram of an inner delivery assembly of a double-balloon vertebroplasty implant device of the present invention;

[0032] Figure 7 is a schematic structural diagram of an outer delivery assembly of a double-balloon vertebroplasty implant device of the present invention;

[0033] Figure 8 is a schematic structural diagram of an outer delivery assembly of a double-balloon vertebroplasty implant device of the present invention;

[0034] Figure 9 is a schematic structural diagram of an outer delivery assembly of a double-balloon vertebroplasty implant device of the present invention;

[0035] Figure 10 is a schematic structural diagram of an outer tube assembly of a double-balloon vertebroplasty implant device of the present invention;

[0036] Figure 11 is a schematic structural diagram of a liner core assembly of a double-balloon vertebroplasty implant device of the present invention;

[0037] Figure 12 Surgical flowchart of Embodiment 1 of the present invention;

[0038] Figure 13 Schematic structural diagram of the bending angle adjustment assembly of a double-balloon vertebroplasty implant instrument of the present invention;

[0039] Figure 14 Schematic structural diagram of the bending angle adjustment assembly of a double-balloon vertebroplasty implant instrument of the present invention;

[0040] Figure 15 Schematic structural diagram of the bending angle adjustment assembly of a double-balloon vertebroplasty implant instrument of the present invention;

[0041] Figure 16 Surgical flowchart of Embodiment 2 of the present invention;

[0042] Among them, the reference numerals include: inner delivery assembly 1; inner balloon 11; inner balloon head 111; inner balloon connecting tube 12; inner balloon pressing tube 13; inner balloon handle 14; inner balloon connecting tube handle 141; inner balloon pressing tube handle 142; inner balloon injection port 1421; outer delivery assembly 2; outer balloon 21; outer balloon head 211; outer balloon connecting tube 22; outer balloon pressing tube 23; outer balloon handle 24; outer balloon connecting tube handle 241; outer balloon injection port 2411; outer balloon pressing tube handle 242; outer tube assembly 3; outer tube 31; outer tube handle 32; liner core assembly 4; liner core 41; liner core handle 42; bending angle adjustment assembly 5; adjustment handle 51; adjustment tube 52. Detailed implementation manners

[0043] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0044] It should be noted that, without conflict, the embodiments in the present invention and the features in the embodiments may be combined with each other.

[0045] Next, the present invention will be further described in conjunction with the accompanying drawings and specific embodiments, but it is not a limitation of the present invention.

[0046] Example 1

[0047] This embodiment provides a double-balloon vertebroplasty implant instrument, as Figures 1 - 3 shown, including: an inner delivery assembly 1, an outer delivery assembly 2, and an outer tube assembly 3;

[0048] AsFigures 4 - 6 As shown, the inner delivery component 1 includes an inner balloon 11, an inner balloon connecting tube 12, an inner balloon pressing tube 13 and an inner balloon handle 14; the inner balloon 11 is made of medical polymer material, and after being formed, it is cylindrical, dumbbell-shaped or multi-convex and has no micropores, and a distally closed inner balloon head 111 is fixedly provided at the distal end; the proximal end of the inner balloon head 111 has a blind hole opening toward the inside of the inner balloon 11; the proximal end of the inner balloon 11 is detachably connected to the distal end of the inner balloon connecting tube 12 through the inner balloon pressing tube 13; the distal end of the inner balloon connecting tube 12 and / or the distal end of the inner balloon pressing tube 13 is deformed (including expanding the mouth , closing, step, fixed protrusion or expanding the inner cavity), so that the distal end of the inner balloon connecting tube 12 and the distal end of the inner balloon pressing tube 13 form a line or surface contact when coaxially assembled, so that the proximal end of the inner balloon 11 is fixed between the inner balloon connecting tube 12 and the inner balloon pressing tube 13; the inner balloon handle 14 includes an inner balloon connecting tube handle 141 and an inner balloon pressing tube handle 142; the inner balloon 11 can be disassembled by operating the inner balloon handle 14 to make the inner balloon connecting tube handle 141 and the inner balloon pressing tube handle 142 produce relative movement; the inner balloon pressing tube handle 142 is provided with an inner balloon injection port 1421;

[0049] like Figures 7 - 9 As shown, the outer delivery component 2 includes an outer balloon 21, an outer balloon connecting tube 22, an outer balloon pressing tube 23 and an outer balloon handle 24; the outer balloon 21 is made of medical polymer material, and after being formed, it is cylindrical, dumbbell-shaped or multi-convex and is provided with micropores, and the distal end is also fixedly provided with an outer balloon head 211 with a distal end closed; the proximal end of the outer balloon head 211 has a blind hole opening toward the inside of the outer balloon 21; the proximal end of the outer balloon 21 is detachably connected to the distal end of the outer balloon connecting tube 22 through the outer balloon pressing tube 23; the distal end of the outer balloon connecting tube 22 and / or the distal end of the outer balloon pressing tube 23 is deformed (including expansion, The outer balloon 21 is provided with an outer balloon connecting tube handle 241 and an outer balloon pressing tube handle 242. The outer balloon 21 is disassembled by operating the outer balloon handle 24 to make the outer balloon connecting tube handle 241 and the outer balloon pressing tube handle 242 move relative to each other. The outer balloon 21 is provided with an outer balloon injection port 2411.

[0050] like Figure 10As shown, the outer tube assembly 3 includes an outer tube 31 and an outer tube handle 32 connected to the proximal end of the outer tube 31; the outer tube 31 has an axial stiffness that can withstand the thrust for tissue cavity opening without deformation, with the proximal part being a rigid section and the distal part being a flexible section. The flexible section is rigid in the radial direction and is formed by cutting a metal tube, made of a shape memory alloy, made of a spring, made of a medical polymer material, or composed of a combination of a metal material and a polymer material;

[0051] Wherein, the distal end of the inner balloon head 111 is sleeved and abutted against the blind hole of the outer balloon head 211; the inner balloon pressing tube handle 142 is hermetically connected to the outer balloon connecting tube handle 241; the outer tube 31 is sleeved outside the outer balloon pressing tube 23 and the outer balloon 21.

[0052] Example 2

[0053] This embodiment provides a double-balloon vertebroplasty implant device, such as Figures 1 - 3 As shown, it includes: an inner delivery assembly 1, an outer delivery assembly 2, an outer tube assembly 3, and a liner core assembly 4;

[0054] Such as Figures 4 - 6 As shown, the inner delivery assembly 1 includes an inner balloon 11, an inner balloon connecting tube 12, an inner balloon pressing tube 13, and an inner balloon handle 14; the inner balloon 11 is made of a medical polymer material, and after forming, it is in a cylindrical shape, dumbbell shape, or multi-protrusion shape and has no micropores provided thereon. A distal closed inner balloon head 111 is also fixedly provided at the distal end; the proximal end of the inner balloon head 111 has a blind hole with an opening facing the inside of the inner balloon 11; the proximal end of the inner balloon 11 is detachably connected to the distal end of the inner balloon connecting tube 12 through the inner balloon pressing tube 13; the distal end of the inner balloon connecting tube 12 and / or the distal end of the inner balloon pressing tube 13 are subjected to deformation treatment (including flaring, necking, steps, fixed protrusions, or enlarging the inner cavity), so that when the distal ends of the inner balloon connecting tube 12 and the inner balloon pressing tube 13 are coaxially assembled, a line or surface contact is formed, thereby fixing the proximal end of the inner balloon 11 between the inner balloon connecting tube 12 and the inner balloon pressing tube 13; the inner balloon handle 14 includes an inner balloon connecting tube handle 141 and an inner balloon pressing tube handle 142; by operating the inner balloon handle 14 to make the inner balloon connecting tube handle 141 and the inner balloon pressing tube handle 142 move relatively, the disassembly of the inner balloon 11 can be achieved; an inner balloon injection port 1421 is provided on the inner balloon pressing tube handle 142;

[0055] Such as Figures 7 - 9As shown in the figure, the outer delivery assembly 2 includes an outer balloon 21, an outer balloon connecting tube 22, an outer balloon pressing tube 23, and an outer balloon handle 24; the outer balloon 21 is made of a medical polymer material, and after forming, it is cylindrical, dumbbell-shaped or multi-protrusion-shaped and is provided with micropores thereon, and a distal closed outer balloon head 211 is fixedly provided at the distal end; the proximal end of the outer balloon head 211 has a blind hole with an opening facing the inside of the outer balloon 21; the proximal end of the outer balloon 21 is detachably connected to the distal end of the outer balloon connecting tube 22 through the outer balloon pressing tube 23; the distal end of the outer balloon connecting tube 22 and / or the distal end of the outer balloon pressing tube 23 are subjected to deformation treatment (including flaring, necking, steps, fixing protrusions or expanding the inner cavity), so that when the distal ends of the outer balloon connecting tube 22 and the outer balloon pressing tube 23 are coaxially assembled, they form a line or surface contact, thereby fixing the proximal end of the outer balloon 21 between the outer balloon connecting tube 22 and the outer balloon pressing tube 23; the outer balloon handle 24 includes an outer balloon connecting tube handle 241 and an outer balloon pressing tube handle 242; by operating the outer balloon handle 24 to make the outer balloon connecting tube handle 241 and the outer balloon pressing tube handle 242 generate relative movement, the disassembly of the outer balloon 21 can be achieved; an outer balloon injection port 2411 is provided on the outer balloon connecting tube handle 241;

[0056] As Figure 10 shown in the figure, the outer tube assembly 3 includes an outer tube 31 and an outer tube handle 32 connected to the proximal end of the outer tube 31; the proximal part of the outer tube 31 is a rigid section, and the distal part is a flexible section, and the flexible section is rigid in the radial direction and is formed by cutting a metal tube, made of a shape memory alloy, made of a spring, made of a medical polymer material, or composed of a combination of a metal material and a polymer material;

[0057] As Figure 11 shown in the figure, the core component 4 includes a core 41 and a core handle 42; the core 41 is slidably inserted into the inner balloon connecting tube 12 and abuts against the blind hole of the inner balloon head 111; the core handle 42 is provided at the proximal end of the core 41;

[0058] Among them, the distal end of the inner balloon head 111 is sleeved and abuts against the blind hole of the outer balloon head 211; the inner balloon pressing tube handle 142 is hermetically connected to the outer balloon connecting tube handle 241; the outer tube 31 is sleeved outside the outer balloon pressing tube 23 and the outer balloon 21; the outer tube 31 and / or the core 41 have a stiffness in the axial direction that can withstand the thrust of tissue cavity opening without deformation.

[0059] As Figure 12 shown in the figure, the specific surgical procedure is as follows:

[0060] S1, inserting the double-balloon vertebroplasty implant into the target vertebra along the working channel, and withdrawing the outer tube 31 by operating the outer tube handle 32 until the outer balloon 21 is completely exposed;

[0061] S2, operate the liner handle 42, withdraw the liner handle 42 from the inner balloon connecting tube 12, and inject the bone filler into the inner balloon 11 through the inner balloon injection port 1421 to expand the inner balloon 11;

[0062] S3, injecting a bone filler into the outer balloon 21 through the outer balloon injection port 2411, so that the outer balloon 21 expands and the bone filler seeps out from the micropores, so that the outer balloon 21 is riveted to the vertebral body;

[0063] S4, respectively operate the inner balloon connecting tube handle 141 and the outer balloon pressing tube 23 to release the inner balloon 11 and the outer balloon 21, and finally withdraw the instruments to complete the operation.

[0064] Example 3

[0065] This embodiment provides a double-balloon vertebroplasty implant device, such as Figures 1 - 3 As shown, it includes: an inner conveying assembly 1, an outer conveying assembly 2, an outer tube assembly 3, a liner core assembly 4 and a bend angle adjustment assembly 5;

[0066] like Figures 4 - 6 As shown, the inner delivery component 1 includes an inner balloon 11, an inner balloon connecting tube 12, an inner balloon pressing tube 13 and an inner balloon handle 14; the inner balloon 11 is made of medical polymer material, and after being formed, it is cylindrical, dumbbell-shaped or multi-convex and has no micropores, and a distally closed inner balloon head 111 is fixedly provided at the distal end; the proximal end of the inner balloon head 111 has a blind hole opening toward the inside of the inner balloon 11; the proximal end of the inner balloon 11 is detachably connected to the distal end of the inner balloon connecting tube 12 through the inner balloon pressing tube 13; the distal end of the inner balloon connecting tube 12 and / or the distal end of the inner balloon pressing tube 13 is deformed (including expanding the mouth , closing, step, fixed protrusion or expanding the inner cavity), so that the distal end of the inner balloon connecting tube 12 and the distal end of the inner balloon pressing tube 13 form a line or surface contact when coaxially assembled, so that the proximal end of the inner balloon 11 is fixed between the inner balloon connecting tube 12 and the inner balloon pressing tube 13; the inner balloon handle 14 includes an inner balloon connecting tube handle 141 and an inner balloon pressing tube handle 142; the inner balloon 11 can be disassembled by operating the inner balloon handle 14 to make the inner balloon connecting tube handle 141 and the inner balloon pressing tube handle 142 produce relative movement; the inner balloon pressing tube handle 142 is provided with an inner balloon injection port 1421;

[0067] As Figures 7 - 9 shown, the outer delivery assembly 2 includes an outer balloon 21, an outer balloon connecting tube 22, an outer balloon pressing tube 23, and an outer balloon handle 24; the outer balloon 21 is made of a medical polymer material, and after forming, it is cylindrical, dumbbell-shaped, or multi-protrusion-shaped and is provided with micropores thereon, and a distal closed outer balloon head 211 is fixedly provided at the distal end; the proximal end of the outer balloon head 211 has a blind hole with an opening facing the inside of the outer balloon 21; the proximal end of the outer balloon 21 is detachably connected to the distal end of the outer balloon connecting tube 22 through the outer balloon pressing tube 23; the distal end of the outer balloon connecting tube 22 and / or the distal end of the outer balloon pressing tube 23 are subjected to deformation treatment (including flaring, necking, steps, fixing protrusions, or expanding the inner cavity), so that when the distal ends of the outer balloon connecting tube 22 and the outer balloon pressing tube 23 are coaxially assembled, they form a line or surface contact, thereby fixing the proximal end of the outer balloon 21 between the outer balloon connecting tube 22 and the outer balloon pressing tube 23; the outer balloon handle 24 includes an outer balloon connecting tube handle 241 and an outer balloon pressing tube handle 242; by operating the outer balloon handle 24 to make the outer balloon connecting tube handle 241 and the outer balloon pressing tube handle 242 move relative to each other, the disassembly of the outer balloon 21 can be achieved; an outer balloon injection port 2411 is provided on the outer balloon connecting tube handle 241;

[0068] As Figure 10 shown, the outer tube assembly 3 includes an outer tube 31 and an outer tube handle 32 connected to the proximal end of the outer tube 31; the proximal part of the outer tube 31 is a rigid section, and the distal part is a flexible section, and the flexible section is rigid in the radial direction and is formed by cutting a metal tube, made of a shape memory alloy, made of a spring, made of a medical polymer material, or composed of a combination of a metal material and a polymer material;

[0069] As Figure 11 shown, the core assembly 4 includes a core 41 and a core handle 42; the core 41 is slidably inserted into the inner balloon connecting tube 12 and abuts against the blind hole of the inner balloon head 111; the core handle 42 is provided at the proximal end of the core 41;

[0070] As Figures 13 - 15 shown, the bend angle adjustment assembly 5 includes an adjustment handle 51 and an adjustment tube 52; the adjustment handle 51 is provided at the proximal end of the adjustment tube 52; the distal curved section parts of the inner delivery assembly 1, the outer delivery assembly 2, and the outer tube assembly 3 are pre-installed in the adjustment tube 52, and the release and recovery of the curved section parts are realized by operating the adjustment handle 51.

[0071] The distal end of the inner balloon sealing head 111 is sleeved against the blind hole of the outer balloon sealing head 211; the inner balloon compression tube handle 142 is sealed and connected to the outer balloon connecting tube handle 241; the outer tube 31 is sleeved on the outer balloon compression tube 23 and the outer balloon 21; the outer tube 31 and / or the liner core 41 have axial rigidity to withstand the thrust of tissue cavitation without deformation.

[0072] like Figure 16 and Figure 12 The specific surgical procedures are as follows:

[0073] S1, inserting the double-balloon vertebroplasty implant along the working channel, and operating the adjustment handle 51 to allow the inner delivery component 1, the outer delivery component 2 and the curved section of the outer tube component 3 to enter the vertebral body;

[0074] S2, withdrawing the outer tube 31 by operating the outer tube handle 32 until the outer balloon 21 is completely exposed;

[0075] S3, operate the liner handle 42, withdraw the liner handle 42 from the inner balloon connecting tube 12, and inject the bone filler into the inner balloon 11 through the inner balloon injection port 1421 to expand the inner balloon 11;

[0076] S4, injecting a bone filler into the outer balloon 21 through the outer balloon injection port 2411, so that the outer balloon 21 expands and the bone filler seeps out from the micropores, so that the outer balloon 21 is riveted to the vertebral body;

[0077] S5. Operate the inner balloon connecting tube handle 141 and the outer balloon pressing tube 23 respectively to release the inner balloon 11 and the outer balloon 21, and finally withdraw the instruments to complete the operation.

[0078] To summarize, a double-balloon vertebroplasty implant device of the present invention comprises an inner balloon and an outer balloon, wherein the inner balloon is not provided with micropores, and the outer balloon is provided with micropores. After the device establishes a cavity, a bone filler is first injected into the inner balloon, so that the inner balloon is expanded to a required height in the vertebral body, which is beneficial to maintaining the mechanical structure inside the vertebral body; then the bone filler is injected into the outer balloon, so that part of the bone filler seeps out from the micropores of the outer balloon, so that the balloon and the vertebral body achieve a better riveting effect; the fixed angle portion at the distal end of the outer tube is pre-installed in the adjusting tube, so that the device can pass through the working channel straightly, so that the operator does not need to laboriously put the device into the working channel, and the fixed angle portion at the distal end of the outer tube is released and recovered by operating the adjusting tube handle.

[0079] The above are only the preferred embodiments of the present invention, and do not limit the implementation manners and protection scope of the present invention. For those skilled in the art, it should be realized that all the equivalent replacements and obvious changes made by using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims

1. A double-balloon vertebroplasty implant device, characterized in that, it comprises: an inner delivery assembly (1), an outer delivery assembly (2) and an outer tube assembly (3); The inner delivery assembly (1) includes an inner balloon (11), an inner balloon connecting tube (12), an inner balloon pressing tube (13) and an inner balloon handle (14); the inner balloon (11) is cylindrical, dumbbell-shaped or multi-protrusion-shaped after forming and has no micropores thereon, and a distal closed inner balloon head (111) is fixedly arranged at the distal end; the proximal end of the inner balloon head (111) has a blind hole with an opening facing the inside of the inner balloon (11); the proximal end of the inner balloon (11) is detachably connected to the distal end of the inner balloon connecting tube (12) through the inner balloon pressing tube (13); the inner balloon handle (14) includes an inner balloon connecting tube handle (141) and an inner balloon pressing tube handle (142); by operating the inner balloon handle (14) to make the inner balloon connecting tube handle (141) and the inner balloon pressing tube handle (142) move relatively, the disassembly of the inner balloon (11) can be achieved; an inner balloon injection port (1421) is arranged on the inner balloon pressing tube handle (142); The outer delivery assembly (2) includes an outer balloon (21), an outer balloon connecting tube (22), an outer balloon pressing tube (23) and an outer balloon handle (24); the outer balloon (21) is cylindrical, dumbbell-shaped or multi-protrusion-shaped after forming and has micropores thereon, and a distal closed outer balloon head (211) is fixedly arranged at the distal end; the proximal end of the outer balloon head (211) has a blind hole with an opening facing the inside of the outer balloon (21); the proximal end of the outer balloon (21) is detachably connected to the distal end of the outer balloon connecting tube (22) through the outer balloon pressing tube (23); the outer balloon handle (24) includes an outer balloon connecting tube handle (241) and an outer balloon pressing tube handle (242); by operating the outer balloon handle (24) to make the outer balloon connecting tube handle (241) and the outer balloon pressing tube handle (242) move relatively, the disassembly of the outer balloon (21) can be achieved; an outer balloon injection port (2411) is arranged on the outer balloon connecting tube handle (241); The outer tube assembly (3) includes an outer tube (31) and an outer tube handle (32) connected to the proximal end of the outer tube (31); the proximal part of the outer tube (31) is a rigid section, and the distal part is a flexible section, and the flexible section is rigid in the radial direction; wherein, the distal end of the inner balloon head (111) is sleeved and abutted against the blind hole of the outer balloon head (211); the inner balloon pressing tube handle (142) is hermetically connected to the outer balloon connecting tube handle (241); the outer tube (31) is sleeved outside the outer balloon pressing tube (23) and the outer balloon (21).

2. The double-balloon vertebroplasty implant device according to claim 1, characterized in that, the inner balloon (11) is made of a medical polymer material.

3. The double-balloon vertebroplasty implant device according to claim 1, characterized in that, The distal end of the inner balloon connecting tube (12) and / or the distal end of the inner balloon pressing tube (13) are subjected to deformation treatment, such that when the distal ends of the inner balloon connecting tube (12) and the inner balloon pressing tube (13) are coaxially assembled, a line or surface contact is formed, thereby fixing the proximal end of the inner balloon (11) between the inner balloon connecting tube (12) and the inner balloon pressing tube (13).

4. The double-balloon vertebroplasty implant device according to claim 1, wherein, the outer balloon (21) is made of a medical polymer material.

5. The double-balloon vertebroplasty implant device according to claim 1, wherein, The distal end of the outer balloon connecting tube (22) and / or the distal end of the outer balloon pressing tube (23) are subjected to deformation treatment, such that when the distal ends of the outer balloon connecting tube (22) and the outer balloon pressing tube (23) are coaxially assembled, a line or surface contact is formed, thereby fixing the proximal end of the outer balloon (21) between the outer balloon connecting tube (22) and the outer balloon pressing tube (23).

6. The double-balloon vertebroplasty implant device according to claim 3 or 5, wherein, the deformation treatment includes flaring, necking, steps, fixing protrusions or enlarging the inner cavity.

7. The double-balloon vertebroplasty implant device according to claim 1, wherein, The flexible section of the outer tube (31) is formed in the following ways: formed by cutting a metal tube, formed by a shape memory alloy, formed by a spring, formed by a medical polymer material, or formed by a combination of a metal material and a polymer material.

8. The double-balloon vertebroplasty implant device according to claim 1, wherein, further comprising: a liner core assembly (4); The liner core assembly (4) includes a liner core (41) and a liner core handle (42); the liner core (41) is slidably inserted into the inner balloon connecting tube (12) and abuts against the blind hole of the inner balloon head (111); the liner core handle (42) is provided at the proximal end of the liner core (41).

9. The double-balloon vertebroplasty implant device according to claim 8, wherein, The outer tube (31) and / or the liner core (41) axially have a stiffness that can withstand the thrust of tissue cavity opening without deformation.

10. The double-balloon vertebroplasty implant device according to claim 1, wherein, further comprising: an angulation adjustment assembly (5); The angulation adjustment assembly (5) includes an adjustment handle (51) and an adjustment tube (52); the adjustment handle (51) is provided at the proximal end of the adjustment tube (52); the distal curved section parts of the inner delivery assembly (1), the outer delivery assembly (2) and the outer tube assembly (3) are pre-installed in the adjustment tube (52), and the release and recovery of the curved section parts are realized by operating the adjustment handle (51).

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