WO2013078779A1 - Biodegradable macromolecule reticular balloon, manufacturing thereof, balloon-sealing apparatus and balloon-transporting apparatus - Google Patents

Abstract

Provided are a biodegradable macromolecule reticular balloon, a manufacturing method therefor, a balloon-fixing/sealing apparatus, and a balloon-transporting apparatus. The balloon is a hollow balloon acquired by electrospinning a biodegradable polymer that is then received by a balloon-receiving apparatus. The fixing/sealing apparatus comprises a balloon-fixing inner sleeve-tube and a balloon-fixing outer sleeve-tube. The balloon-fixing inner sleeve-tube and the balloon-fixing outer sleeve-tube fix the tail end of the balloon. The balloon-transporting apparatus is combined with the balloon-fixing outer sleeve-tube.

Description

 Degradable polymer mesh balloon and preparation, balloon sealing device and conveying device

 The invention relates to a degradable polymer mesh balloon supporting surgical device, in particular to a degradable polymer mesh balloon and a preparation, a balloon sealing device and a conveying device.

Background technique

 Trauma, diseases (such as systemic diseases, tumors, etc.) and osteoporosis can cause vertebral fractures. Severe pain and limited mobility caused by vertebral fractures reduce the quality of life books, and may have secondary lesions, even paraplegia and death. The ideal treatment should be able to quickly reduce the pain caused by the fracture, correct the kyphosis caused by the fracture, and restore the patient's ability to move as soon as possible. There are currently three main treatment methods: traditional conservative treatment, traditional surgical open surgery and minimally invasive surgery. Compared with the other two methods, minimally invasive surgery has a short treatment time, small wounds, less pain, less blood loss, shorter recovery time and shorter hospital stay, so it is gradually being widely used and will become the mainstream treatment method in the future.

 Minimally invasive surgery such as percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are performed by directly perforating the needle into the fractured vertebral body, directly into the bone cement or dilating with a dilator. After the bone cement is injected, the height of the fractured vertebral body is restored to a certain extent, and the vertebral body is quickly reinforced to achieve the purpose of relieving pain and recovering as soon as possible. At present, there are two main problems in minimally invasive surgery. One is the problem caused by the bone cement used as the acrylic resin bone cement, and the other is the problem caused by the leakage of the bone cement. Acrylic resin bone cement has high hardness and does not promote bone growth, which can lead to the occurrence of secondary fractures and vertebral fracture signs of adjacent vertebral bodies, which cannot be applied to young people. It is therefore necessary to explore the clinical use of other bone cement substitutes.

Calcium phosphate cement has a microporous structure and a calcium component, and thus has many advantages, such as bone growth, which is conducive to the growth of new bone, recovery of vertebral bone mass and twist. However, due to its water collapse and low pressure bearing capacity, it cannot be applied to vertebral surgery. Some devices have been developed clinically to reduce the collapse of bone cement. For example, A-Spine Asia developed a Vessel-X filling net bag (Spine. 2007; 32: 2076-2082), which is made of non-elastic polyterephthalic acid. The ethylene glycol ester constitutes a two-layer mesh structure. Recently, Rotter R. et al. (Eur. Spine J. 2010; 19: 916-923) developed a metal mesh stent. However, these stents are non-elastic and non-degradable and may Bring long-term risks. In addition, Vessel-X filling mesh bags and metal mesh stents have mesh sizes of lOOMm and 100mm, respectively, which may not prevent the calcium phosphate cement from collapsing with water, and thus cannot be applied to the clinical use of calcium phosphate cement. In theory, if calcium phosphate cement is injected into a biodegradable and biocompatible balloon, the two limitations of the calcium-calcium cement can be suppressed. Moreover, during the degradation of the balloon, the calcium sulphate cement can be slowly exposed to the surrounding bone, thereby preserving the bone growth advantage of the calcium phosphate cement.

 In response to this situation, a new technology is needed not only to solve the problem of calcium acid cement bone cement collapse and leakage, but also to bear weight and other problems, but also to maintain the advantages of calcium phosphate cement, release calcium ions, promote new bone formation, and avoid Clinical secondary surgery. At the same time, the degradable polymer mesh balloon needs to be implanted into the injured vertebra and closed the tail end. It is necessary to avoid the bone cement overflowing from the balloon end, and reduce the collapse caused by excessive contact between the bone cement and the body fluid, and ensure the ball. After the bone cement is infused into the capsule, it is kept in an expanded state, and the height loss caused by the withdrawal of the bone expander in other ways of PKP is avoided. It is also necessary to design a fixed sealing device matched with the degradable polymer mesh balloon and Conveying device. Summary of the invention

 In view of the deficiencies in the prior art, the present invention aims to provide a degradable polymer mesh balloon and a preparation, a balloon sealing device and a delivery device.

 According to an aspect of the invention, a degradable polymer reticular balloon for treating a vertebral body fracture is formed by electrospinning a biodegradable polymer material through a balloon receiving device. 2 〜1. 5 μ πι。 The diameter of the fiber is 0. 2~1. 5 μ πι.

 Preferably, the balloon is spherical or ellipsoidal.

 Preferably, the balloon has a burst pressure of 6-20 atmospheres.

 Preferably, the biodegradable polymer material is: polylactic acid, polycaprolactone, polyglycolic acid, lactic acid-glycolic acid copolymer, any two or two of block copolymers of lactic acid and caprolactone The above blends.

 Preferably, the polylactic acid is: D-type polylactic acid, L-type polylactic acid or a blended product of the two, or a copolymerized product of the two.

According to another aspect of the present invention, a method for preparing a degradable polymer reticular balloon for treating a vertebral body fracture is as follows: the specific steps of the method are: dissolving the biodegradable polymer material in an organic solvent to prepare a solution having a mass percentage of 1 to 30%; using an electrospinning method, and controlling the ejection rate to 0. l~2. 0mL / h, the voltage is 3~30kV _{; the} balloon receiving device is a titanium alloy rod, the distance between the ejector spout and the balloon receiving device is l~20cm, the balloon receiving device The rotation speed is l~100 rpm, and the discharged fibers are collected for a time of l~8h, that is, a degradable polymer mesh balloon is obtained.

 Preferably, the organic solvent is at least one of chloroform, methanol, ethanol, dichloromethane, acetone, dimethylformamide, toluene, trichloromethane and hexamethylene.

 According to another aspect of the present invention, a fixed closure device for a degradable polymeric mesh balloon includes a balloon-fixed inner cannula, a balloon-fixed outer cannula, and a threaded embolus, wherein the balloon is fixed The inner wall of the inner sleeve is provided with a threaded plug fixing thread, the inner wall of the balloon fixing outer sleeve is provided with a balloon delivery device fixing thread, and the threaded plug is provided with a balloon fixing inner sleeve fixing thread, The proximal end of the threaded plug is provided with a push rod fixing groove, the balloon fixing outer sleeve is sleeved outside the outer wall of the balloon tail end, and the inner wall of the balloon tail end is sleeved outside the balloon fixed inner sleeve Between the balloon-fixed inner cannula and the threaded emboss, the threaded screw and the balloon-fixed inner cannula are fixedly threaded by a matching screw thread, and the length of the balloon-fixed inner cannula is shorter than The balloon secures the length of the outer cannula.

 Preferably, the balloon delivery device fixing thread is only distributed in a proximal end region of the inner wall of the balloon-fixed outer cannula, and the distal end region of the inner wall of the balloon-fixing outer cannula is the outer wall contact surface of the balloon tail end, the balloon The inner wall of the fixed outer cannula is in close contact with the outer wall of the balloon distal end. The outer wall of the balloon fixed inner cannula is the inner wall contact surface of the balloon tail end, and the outer wall of the balloon fixed inner cannula is in close contact with the inner wall of the balloon distal end.

 Preferably, the outer diameter of the balloon-fixed inner cannula is slightly smaller than the inner diameter of the balloon-fixed outer cannula. Preferably, the push rod fixing groove is a slotted screwdriver groove.

 Preferably, the balloon-fixed inner cannula, the balloon-fixed outer cannula, and the threaded emboss are all made of a degradable material, or a titanium alloy material.

 According to another aspect of the present invention, there is also provided a delivery device for a degradable polymeric mesh balloon, comprising a balloon delivery device, and a pusher, wherein the balloon delivery device comprises a hollow tubular body portion, and a fixation a rod, a distal end of the hollow tubular body portion is provided with a balloon-fixing outer cannula fixing thread, a proximal end of the hollow tubular body portion is provided with a cementing device fixing thread, and the fixing rod is connected to the hollow tubular body The push rod includes a screwdriver portion and a push rod cap connected to a proximal end of the screwdriver portion, the distal end of the screwdriver portion is a threaded plug fixing a screwdriver head, and the screwdriver head is fixed with a threaded plug push rod The grooves match. The hollow tubular body portion of the balloon delivery device is sleeved outside the screwdriver portion of the pusher, and the screwdriver portion of the pusher is longer than the hollow tubular body portion of the balloon delivery device.

Preferably, the axial direction of the fixing rod is perpendicular to the axial direction of the hollow tubular body portion. Preferably, the threaded plug fixes the screwdriver head to be a slotted screwdriver head.

 Preferably, the balloon delivery device and the push rod are each made of a medical steel material, wherein the cemented material of the balloon delivery device and the push rod cap of the push rod may also be made of a plastic material.

 According to still another aspect of the present invention, there is also provided a fixed closure and delivery device for a degradable polymeric mesh balloon, comprising a balloon-fixed inner cannula, a balloon-fixed outer cannula, a threaded embolus, a balloon delivery device, and a push rod, wherein an inner wall of the balloon-fixing inner sleeve is provided with a threaded plug fixing thread, and an inner wall of the balloon-fixing outer sleeve is provided with a balloon delivery device fixing thread, and the threaded plug is provided with a ball The capsule fixing inner sleeve fixing thread, the proximal end of the threaded plug is provided with a push rod fixing groove, the balloon fixing outer sleeve is sleeved on the outer wall of the balloon tail end, and the inner end wall of the balloon tail end is sleeved on the In addition to the balloon-fixed inner cannula, the balloon-fixed inner cannula and the threaded plug are fixedly threaded by a matching threaded plug fixing thread and a balloon-fixed inner cannula, the balloon The length of the fixed inner cannula is shorter than the length of the balloon-fixed outer cannula; the balloon delivery device comprises a hollow tubular body portion, and a fixing rod, and the distal end of the hollow tubular body portion is provided with a balloon fixing jacket a tube fixing thread, a proximal end of the hollow tubular body portion is provided with a bone cement filling device fixing thread, the fixing rod is connected to the hollow tubular body portion, the push rod comprises a screwdriver portion, and is connected to the screwdriver portion a proximal push rod cap, the distal end of the screwdriver portion is a threaded plug fixing a screwdriver head, the hollow tubular body portion is sleeved outside the screwdriver portion, and the length of the screwdriver portion is longer than the hollow tubular body portion The length of the push rod fixing groove is matched with the threaded plug fixing screwdriver head, and the ball fixing fixed outer sleeve and the balloon conveying device fix the thread and the ball through the matched balloon conveying device The balloon is fixed to the outer sleeve to fix the threaded connection.

 Preferably, the balloon-fixed inner cannula, the balloon-fixed outer cannula, and the threaded emboss are all made of a degradable material, or a titanium alloy material.

 Preferably, the balloon-fixed inner cannula, the balloon-fixed outer cannula, and the threaded emboss are both made of a degradable material or a titanium alloy material; the balloon delivery device and the push rod can be made of medical steel material. The pusher cap for fixing the threaded portion of the cementing device of the balloon delivery device and the push rod may also be made of a plastic material.

The technical solution part of the degradable polymer mesh balloon and the preparation method thereof for treating vertebral body fracture according to the present invention is characterized in that the degradable polylactic acid and polycaprolactone block copolymer (PCLLA-CL) are used as raw materials. The PCLLA-CL fiber prepared by the electrospinning method has a microporous network-like balloon-like structure, and the balloon has a biodegradable polymer balloon with good mechanical properties, degradable, high mechanical strength and good flexibility. The prepared balloon has a nominal pressure of 8 atmospheres, a burst pressure of 14 atmospheres, and a tensile strength of 8 MPa. After the bone cement is injected into the balloon, a small amount of bone cement is observed to exude, so that the height of the compressed vertebral body can be raised or even completely recovered. The degradation quality in serum for two weeks is 10-20% (w/w). It solves the problems of bone cement collapse and leakage, which not only compensates for PVP and PKP defects, but also expands the scope of surgery. Moreover, the preparation process of the method of the invention is simple.

 The technical solution part of the degradable polymer mesh balloon sealing device and the conveying device of the present invention is achieved by fixing the balloon inner sleeve and the balloon fixing outer sleeve to fix the balloon tail end according to the following manner. The balloon-fixed outer cannula and the balloon delivery device are screwed together and delivered to the injured vertebra, and the bone cement is injected into the balloon through the balloon delivery device to expand the balloon and raise the height of the compressed vertebral body. The front end of the push rod is coupled to the threaded plug by a slotted screwdriver head, and the threaded plug is pushed to the position of the balloon-fixed inner sleeve and rotated to close the balloon. Finally, the push rod is directly withdrawn, and the balloon delivery device is rotated and separated from the fixture to be withdrawn. The invention solves the problem of fixed sealing of the degradable polymer mesh balloon and its operation operation. It can prevent bone cement from overflowing, reduce excessive contact between bone cement and body fluids, and cause bone cement to collapse, maximally keep the balloon inflated and prevent high intraoperative loss. The balloon fixation device is composed of degradable materials (polymer, metal, etc.) or titanium alloy. The former can be finally degraded in the body, and the latter has little effect on the healing of vertebral fractures.

DRAWINGS

 Other features, objects, and advantages of the present invention will become more apparent from the Detailed Description of Description

 Figure 1 shows a schematic view of the structure of an unexpanded balloon. In Fig. 1, subgraphs A, B, C, and D are a bottom view, a perspective view, a front view, and a left view, respectively, of the unexpanded balloon.

 Figure 2 shows a schematic view of the structure of the balloon-mounted inner cannula. In Fig. 2, subgraphs A, B, C, and D are a bottom view, a perspective view, a front view, and a left view, respectively, of the balloon-mounted inner cannula.

 Figure 3 shows a schematic view of the structure of the balloon-fixed outer cannula. In Fig. 3, subgraphs A, B, C, and D are a bottom view, a perspective view, a front view, and a left view, respectively, of the balloon-fixed outer cannula.

 Figure 4 shows a schematic view of the structure of the threaded plug. In Figure 4, subgraphs A, B, (:, and D are the bottom, perspective, front, and left views of the threaded plug, respectively.

 Fig. 5 shows a schematic structural view of a balloon delivery device. In Fig. 5, subgraphs A, B, and C are a bottom view, a front view, and a left side view, respectively, of the balloon delivery device.

Fig. 6 is a view showing the structure of the push rod. In Fig. 6, subgraphs A, B, and C are a bottom view, a front view, and a left view, respectively, of the push rod. Figure 7 is a schematic view showing the structure of the inflated balloon after the fixed closure device and its supporting instruments are operated. In Fig. 7, subgraphs A, B, C, and D are bottom view, partial enlarged view, front view, and left side view of the inflated balloon after the fixed closure device and its supporting instruments are respectively operated, wherein subgraph B is subgraph A. An enlarged view of the central balloon fixed inner cannula, the balloon distal end portion, the balloon-fixed outer cannula, the distal end portion of the hollow tubular body portion of the balloon delivery device, and the distal end portion of the pusher screwdriver portion.

 Fig. 8 is a structural schematic view showing the connection relationship between the fixed closed balloon, the balloon-fixed inner cannula, the balloon-fixed outer cannula, and the threaded emboss. In Fig. 8, subgraphs A, B, C, and D are bottom, perspective, front, and right views of the fixedly closed expanded balloon.

 Figure 9 shows a cross-sectional view of the inflated balloon after fixation.

 In the picture:

 1 is a balloon;

 10 is the end of the balloon;

 2 is a balloon fixed inner cannula;

 20 is a threaded plug fixing thread;

 3 is a balloon fixed outer sleeve;

 30 is a fixed thread of the balloon delivery device;

 4 is a threaded plug;

 41 is a balloon fixed inner sleeve fixing thread;

 42 is a push rod fixing groove;

 5 is a balloon delivery device;

 51 is a balloon fixed outer sleeve fixing thread;

 52 is a fixed rod;

 53 is a fixing thread of the bone cement filling device;

 6 is a putter;

 61 is a threaded plug to fix the screwdriver head;

 62 is a putter cap.

detailed description

The embodiments of the present invention are described in detail below with reference to the accompanying drawings. This embodiment is implemented on the premise of the technical solution of the present invention, and the detailed implementation manner and the specific operation process are given, but the protection of the present invention. The scope is not limited to the embodiments described below.

 The degradable polymer mesh balloon for treating vertebral body fracture of the present invention and the preparation method thereof are as follows:

 Example 1

 P (DLLA-CL) 0. 5g, placed in 10mL methanol and dichloromethane mixed solvent, placed at room temperature on a magnetic stirrer until the copolymer is completely dissolved, the solution is transparent; The solution is charged into the syringe in the spray device so that the injection rate is 0. 8 mL / h, a high voltage of 8000 volts is generated between the positive electrode of the needle tip and the negative electrode of the substrate, and the distance between the tip of the needle and the receiving device is 12, and the static electricity is collected. The spun fibers are spun to prepare a balloon. The sample obtained at this time was observed under a scanning electron microscope. The result is shown in Figure 2.

 Example 2:

 P (DLLA-CL) 0. 3 g, put it into a mixed solvent of 8 mL of dimethylformamide and dichloromethane, and place it on a magnetic stirrer at room temperature until the copolymer is completely dissolved. The solution is filled into a syringe in a spray device such that the injection rate is 1.2 mL/h, a high pressure of 12,000 volts is generated between the positive electrode of the needle tip and the negative electrode of the substrate, and the distance between the tip of the needle and the receiving device is 8 mm. The fibers ejected by electrospinning are collected to prepare a balloon. Figure 3 shows the balloon on the receiving device.

 Example 3:

 P (DLLA-CL) 1. 5 g, put it in 20 mL of chloroform solvent, place it on a magnetic stirrer at room temperature and stir until the copolymer is completely dissolved, the solution is transparent; put the above solution into the spray In the syringe in the device, the injection rate is 0.6 mL/h, a high pressure of 10000 volts is generated between the positive electrode of the needle tip and the negative electrode of the substrate, and the distance between the needle tip and the receiving device is 15 awake, and the collection is performed by electrospinning. Fiber, prepared to obtain a balloon.

 Example 4:

 P (DLLA-CL) 0. 8 g, put it into 10 mL of a mixed solvent of dimethylformamide and dichloromethane, and place it on a magnetic stirrer at room temperature until the copolymer is completely dissolved. The solution is filled into a syringe in a spray device such that the injection rate is 1.0 mL/h, a high pressure of 15,000 volts is generated between the positive electrode of the needle tip and the negative electrode of the substrate, and the distance between the tip of the needle and the receiving device is 10 Wake up, collect the fibers sputtered by electrospinning, and prepare a balloon.

The performance parameters of the prepared balloon are as follows: balloon inner diameter is 5 mm, balloon outer diameter is 5. 5 mm, named pressure is 8 atm, burst pressure is 14 atm, tensile strength is 8 MPa, bone cement is injected into the balloon After the microbone exudation, the degradation quality in serum within two weeks was 10-20% (w/w).

 The degradable polymer mesh balloon sealing device and the conveying device of the present invention are as shown in Fig. 1-9, and the specific embodiments thereof are as follows:

 The fixed sealing device and the conveying device of the degradable polymer mesh balloon provided by the invention are relatively simple and convenient to be processed, and can be processed according to the drawings shown in the specification. The fixed sealing device (balloon fixed inner cannula, balloon fixed outer cannula, threaded embossed) is composed of degradable material (degradable polymer, degradable metal, etc.) or titanium alloy, and the conveying device (balloon conveying device and The pusher can be made of medical steel material, wherein the cemented material of the balloon delivery device and the push rod cap of the push rod can also be made of plastic material. Made by metal machining, or injection molded from degradable or plastic materials.

 The fixed sealing device of the degradable polymer mesh balloon of the present invention and the supporting device thereof are also very simple and convenient to use. In a preferred embodiment of the present invention, the balloon fixed inner cannula and the balloon are fixed. The outer cannula fixes the balloon end, the balloon fixed outer cannula and the balloon delivery device are screwed together and delivered to the injured vertebra, and the bone cement is injected into the balloon through the balloon delivery device to expand the balloon and compress the vertebral body. The height is raised. The front end of the push rod is coupled to the threaded plug by a slotted screwdriver head, and the threaded plug is pushed to the position of the balloon-fixed inner sleeve and fixed by rotation to close the balloon. Finally, the push rod is directly withdrawn, and the balloon delivery device is rotated and separated from the fixture to be withdrawn.

 Specifically, a fixed sealing device for a degradable polymer mesh balloon according to a first embodiment of the present invention includes a balloon-fixed inner cannula 2, a balloon-fixed outer cannula 3, and a threaded plug 4, wherein The inner wall of the balloon-contained inner cannula 2 is provided with a threaded plug fixing thread 20, and the inner wall of the balloon-fixing outer sleeve 3 is provided with a balloon delivery device fixing thread 30, and the threaded plug 4 is provided with a balloon Fixing the inner sleeve fixing thread 41, the proximal end of the threaded plug 4 is provided with a push rod fixing groove 42, and the balloon fixing outer sleeve 3 is sleeved outside the outer wall of the balloon tail end 10, the balloon tail The inner wall of the end 10 is sleeved outside the balloon-fixed inner cannula 2, and the ball-fixing inner cannula 2 and the threaded plug 4 are fixed between the thread 20 and the balloon by the matching threaded plug. The cannula fixation thread 41 is threaded and the length of the balloon fixation inner cannula 2 is shorter than the length of the balloon fixation outer cannula 3.

In a preferred embodiment of the present embodiment, the balloon delivery device fixing thread 30 is distributed only in the proximal end region of the inner wall of the balloon-fixing outer cannula 3, and the distal end region of the inner wall of the balloon-fixing outer cannula 3 is The outer wall contact surface of the tail end 10, the inner wall of the balloon fixed outer sleeve 3 is in close contact with the outer wall of the balloon tail end 10, the outer wall of the balloon fixed inner sleeve is the inner wall contact surface of the balloon tail end 10, and the balloon is fixed to the inner sleeve. 2 outer wall and ball The inner wall of the sac end 10 is in intimate contact. The outer diameter of the balloon-fixed inner cannula 2 is slightly smaller than the inner diameter of the balloon-fixed outer cannula 3. The push rod fixing groove 42 is a slotted screwdriver groove. The balloon-fixed inner cannula 2, the balloon-fixed outer cannula 3, and the threaded plug 4 are each made of a degradable material, or a titanium alloy material.

 Further, a delivery device for a degradable polymer mesh balloon according to a second embodiment of the present invention includes a balloon delivery device 5 and a push rod 6, wherein the balloon delivery device 5 includes a hollow tubular body portion And a fixing rod 52, the distal end of the hollow tubular body portion is provided with a balloon fixing outer sleeve fixing thread 51, and the proximal end of the hollow tubular body portion is provided with a bone cement filling device fixing thread 53, the fixing rod 52 Connected to the hollow tubular body portion, the push rod 6 includes a screwdriver portion, and a push rod cap 62 connected to the proximal end of the screwdriver portion, and the distal end of the screwdriver portion is a threaded plug fixing the screwdriver head 61. The hollow tubular body portion of the balloon delivery device 5 is sheathed outside the screwdriver portion of the push rod 6, and the length of the screwdriver portion is longer than the length of the hollow tubular body portion.

 In a preferred embodiment of the embodiment, the axial direction of the fixing rod 52 is perpendicular to the axial direction of the hollow tubular body portion. The threaded plug fixing screwdriver head 61 is a slotted screwdriver head.

A fixed sealing and conveying device for a degradable polymer mesh balloon according to a third embodiment of the present invention, comprising a balloon fixed inner cannula 2, a balloon fixed outer cannula 3, a threaded plug 4, and a balloon delivery device 5 And the push rod 6, wherein the inner wall of the balloon-fixing inner sleeve 2 is provided with a threaded plug fixing thread 20, and the inner wall of the balloon-fixing outer sleeve 3 is provided with a balloon delivery device fixing thread 30, The threaded plug 4 is provided with a balloon-fixing inner sleeve fixing thread 41. The proximal end of the threaded plug 4 is provided with a push rod fixing groove 42, and the balloon fixing outer sleeve 3 is sleeved on the balloon. In addition to the inner sleeve 2, the balloon-fixed inner sleeve 2 and the threaded plug 4 are screwed by the matching threaded plug fixing thread 20 and the balloon-fixing inner sleeve fixing thread 41, The length of the balloon-fixed inner cannula 2 is shorter than the length of the balloon-fixed outer cannula 3; the balloon delivery device 5 includes a hollow tubular body portion, and a fixed rod 52, the distal end of which is disposed a balloon fixed outer sleeve fixing thread 51, the hollow The proximal end of the tubular body portion is provided with a bone cement filling device fixing thread 53, the fixing rod 52 is connected to the hollow tubular body portion, the push rod 6 includes a screwdriver portion, and a push connected to the proximal end of the screwdriver portion a rod cap 62, the distal end of the screwdriver portion is a threaded plug fixing the screwdriver head 61, and the hollow tubular body portion of the balloon delivery device 5 is sleeved outside the screwdriver portion of the push rod 6, the screwdriver portion The length is longer than the length of the hollow tubular body portion; wherein the push rod fixing groove 42 is matched with the threaded plug fixing screwdriver head 61, and the balloon fixing outer sleeve and the balloon conveying device are matched by The balloon delivery device fixation thread 30 is threadedly coupled to the balloon-fixed outer cannula fixation thread 51. The balloon is fixed inside The sleeve 2, the balloon-fixed outer sleeve 3, and the threaded plug 4 are all made of a degradable material, or a titanium alloy material.

 The specific embodiments of the present invention have been described above. It is to be understood that the invention is not limited to the specific embodiments described above, and various modifications and changes can be made by those skilled in the art without departing from the scope of the invention.

Claims

Claim A degradable polymer reticular balloon for treating a vertebral body fracture, characterized in that the reticular balloon is formed by biospinning a polymer material by electrospinning, and is received by a balloon receiving device. 2 〜1. 5 μ πι。 The diameter of the fiber is 0. 2~1. 5 μ πι.  The degradable polymer reticular balloon for treating a vertebral fracture according to claim 1, wherein the balloon is spherical or ellipsoidal.  The degradable polymer reticular balloon for treating a vertebral body fracture according to claim 1, wherein the balloon has a burst pressure of 6 to 20 atmospheres.  The degradable polymer reticular balloon for treating vertebral body fracture according to claim 1, wherein the biodegradable polymer material is: polylactic acid, polycaprolactone, polyglycolic acid, A blend of any two or more of a lactic acid-glycolic acid copolymer, a block copolymer of lactic acid and caprolactone.  The degradable polymer reticular balloon for treating vertebral body fracture according to claim 4, wherein the polylactic acid is: D-type polylactic acid, L-type polylactic acid or a blend product of the two. Or a copolymerization product of both. A method for preparing a degradable polymer reticular balloon for treating a vertebral body fracture according to any one of claims 1 to 5, characterized in that the specific steps of the method are: high biodegradable The molecular material is dissolved in an organic solvent to prepare a solution having a mass percentage of 1 to 30%; using an electrospinning method, and controlling the ejection rate to be 0. 1~2. OmL / h, voltage is 3 to 30 kV _; balloon receiving device For a titanium alloy rod, the distance between the ejector spout and the balloon receiving device is l~20 _Cm , the rotation speed of the balloon receiving device is l~100 rpm, and the ejected fiber is collected for a time of l~8h, that is, A degradable polymer mesh balloon is obtained.  7. The method of claim 6 wherein said organic solvent is at least one of chloroform, methanol, ethanol, dichloromethane, acetone, dimethylformamide, toluene, trichloromethane and n-hexane. One.  8. A fixed closure device for a degradable polymeric mesh balloon, comprising: a balloon-fixed inner cannula (2), a balloon-fixed outer cannula (3), and a threaded plug (4), wherein The inner wall of the balloon-fixing inner sleeve (2) is provided with a threaded plug fixing thread (20), and the balloon fixing the outer sleeve The inner wall of (3) is provided with a balloon delivery device fixing thread (30), and the threaded plug (4) is provided with a balloon fixing inner sleeve fixing thread (41), and the threaded plug (4) is near The end is provided with a push rod fixing concave a groove (42), the balloon-fixed outer sleeve (3) is for being sleeved outside the outer wall of the balloon tail end (10), and the inner wall of the balloon tail end (10) is sleeved on the balloon-fixed inner sleeve (2), the balloon-fixing inner cannula (2) is located inside the balloon-fixed outer cannula (3), the balloon-fixing inner cannula (2) and the threaded plug (4) Threaded by the matching threaded plug fixing thread (20) and the balloon fixing inner sleeve fixing thread (41), the length of the balloon fixing inner sleeve (2) is shorter than the balloon fixing The length of the outer casing (3).  9. The fixed closure device for a degradable polymer mesh balloon according to claim 8, wherein the balloon delivery device fixing thread (30) is distributed only on the balloon-fixed outer cannula (3) The proximal end region of the inner wall, the distal end region of the inner wall of the balloon fixed outer cannula (3) is the outer wall contact surface of the balloon tail end (10), and the inner wall of the balloon fixed outer cannula (3) is used for the end of the balloon (10) The outer wall is in close contact, the outer wall of the balloon fixed inner cannula is the inner wall contact surface of the balloon tail end (10), and the outer wall of the balloon fixed inner sleeve (2) is used for the inner wall of the balloon end (10) Close contact.  The fixed sealing device for a degradable polymer mesh balloon according to claim 8, wherein the outer diameter of the balloon-fixed inner cannula (2) is slightly smaller than the balloon-fixed outer cannula ( 3) The inner diameter.  The fixed sealing device for a degradable polymer mesh balloon according to claim 8, wherein the balloon fixed inner sleeve (2), the balloon fixed outer sleeve (3), and the threaded bolt The sub-(4) is made of a degradable material or a titanium alloy material.  12. A delivery device for a degradable polymeric mesh balloon, comprising: a balloon delivery device (5), and a pusher (6), wherein the balloon delivery device (5) comprises a hollow tubular a body portion, and a fixing rod (52), the distal end of the hollow tubular body portion is provided with a balloon fixing outer sleeve fixing thread (51), the proximal end of the hollow tubular body portion is provided with a bone cement filling device fixing thread (53), the fixing rod (52) is connected to the hollow tubular body portion, and the push rod (6) comprises a screwdriver And a push rod cap (62) connected to the proximal end of the screwdriver portion, the distal end of the screwdriver portion is a threaded plug fixing a screwdriver head (61), the screwdriver head and the threaded plug (4) push rod The fixing groove (42) is matched, the hollow tubular body portion of the balloon conveying device (5) is sleeved outside the screwdriver portion of the push rod (6), and the screwdriver portion is longer than the hollow tubular body portion . The transport device for a degradable polymer mesh balloon according to claim 12, wherein an axial direction of the fixing rod (52) is perpendicular to an axial direction of the hollow tubular body portion. The fixed sealing device for a degradable polymer mesh balloon according to claim 8, or the transport device for a degradable polymer mesh balloon according to claim 12, wherein the threaded plug The fixed screwdriver head (61) is a flat-blade screwdriver head.  15. The apparatus for degradable polymeric mesh balloon according to claim 12, wherein:  - the balloon delivery device (5) and the push rod (6) are both made of medical steel material; or  - the balloon-fixing outer cannula fixing thread (51) and the fixing rod (52) of the balloon delivery device (5), and the screwdriver portion of the push rod (6) are made of medical steel material, the balloon delivery device (5) The cementing device (53) and the pusher cap (62) of the pusher (6) are made of plastic material.  16. A fixed closure and delivery device for a degradable polymeric mesh balloon, comprising: a balloon-fixed inner cannula (2), a balloon-fixed outer cannula (3), a threaded plug (4), Balloon delivery device (5), and a push rod (6), wherein the inner wall of the balloon-fixing inner sleeve (2) is provided with a threaded plug fixing thread (20), and the inner wall of the balloon fixing outer sleeve (3) is set There is a balloon delivery device fixing thread (30), the threaded plug (4) is provided with a balloon fixing inner sleeve fixing thread (41), and the proximal end of the threaded plug (4) is provided with a push rod fixing a groove (42), the balloon fixing outer sleeve (3) is sleeved on the outer wall of the balloon tail end (10), and the inner wall of the balloon tail end (10) is sleeved on the balloon fixed inner sleeve ( 2), the balloon-fixing inner cannula (2) is located within the balloon-fixed outer cannula (3), between the balloon-fixing inner cannula (2) and the threaded plug (4) Threaded by the matched threaded plug fixing thread (20) and the balloon fixed inner sleeve fixing thread (41), the length of the balloon fixing inner sleeve (2) is shorter than the balloon fixing jacket a length of the tube (3); the balloon delivery device (5) comprising a hollow tubular body portion, and a fixing rod (52), the hollow tubular body portion The distal end of the hollow tubular body portion is provided with a bone cement perfusion device fixing thread (53), and the fixing rod (52) is connected to the hollow tube a body portion, the push rod (6) includes a screwdriver portion, and a push rod cap (62) connected to a proximal end of the screwdriver portion, the distal end of the screwdriver portion is a threaded plug fixing a screwdriver head (61) The hollow tubular body portion of the balloon delivery device (5) is sleeved outside the screwdriver portion of the push rod (6), the screwdriver portion is longer than the hollow tubular body portion; wherein the push rod fixing groove (42) mating with a threaded plug fixing screwdriver head (61), the ball fixing outer sleeve and the balloon delivery device are fixed by the matching balloon delivery device (30) Threaded connection to the balloon-fixed outer cannula retaining thread (51). The fixed sealing and conveying device for a degradable polymer mesh balloon according to claim 16, wherein the balloon fixing inner sleeve (2), the balloon fixing outer sleeve (3), and The threaded plugs (4) are made of degradable materials or titanium alloy materials, of which:  - the balloon delivery device (5) and the push rod (6) are both made of medical steel material; or - the balloon-fixing outer cannula fixing thread (51) and the fixing rod (52) of the balloon delivery device (5), and the screwdriver portion of the push rod (6) are made of medical steel material, the balloon delivery device (5) The cementing device (53) and the pusher cap (62) of the pusher (6) are made of plastic material.