CN106073884B - A kind of PVP vertebral oriented dilated balloon-system and its manufacturing method - Google Patents

Abstract

The present invention is a medical device, specifically a PVP vertebral body directional dilation balloon device and a manufacturing method thereof, including a catheter and a guide rod, and also includes: a rotating assembly, the rotating assembly includes a fixed sleeve and is arranged on the The baffle piece on the fixed sleeve, the baffle piece includes: a baffle 1, rotating the fixed sleeve, so that the baffle 1 can cover a pre-blocking position; and at least one baffle 2, along the fixed sleeve Moving the blocking piece 2 in the circumferential direction can make the blocking piece 2 cover at least another pre-blocking position. The PVP vertebral body directional expansion balloon device provided by the present invention can provide a directional expansion function that cannot be solved at present. The position of the stop piece on the head of the fixed sleeve can be adjusted by the knob, and the position of the block moving in the slot can be adjusted. By adjusting the position of the stopper 2, multiple fractures that cannot be stretched can be blocked, so that the balloon can expand in the direction of the preset stretching and reset, so as not to aggravate the degree of fracture damage of the broken parts and avoid causing Refracture.

Description

A kind of PVP vertebral body directional expansion balloon device and its manufacturing method

technical field

The invention relates to the technical field of medical devices, in particular to a PVP vertebral body directional expansion balloon device and a manufacturing method thereof.

Background technique

Vertebral compression fractures have a high incidence in the elderly population. The degree of collapse and compression of each part of the vertebral body at the fracture site is different. For the part with a high degree of compression, it needs to be stretched and reset, and filled with bone cement and other fillers, referred to as PVP surgery. . After the bone cement solidifies, it can increase the strength and stability of the vertebral body, which ensures that the restored vertebral body will not be compressed again, and will not cause the height of the vertebral body and compress the nerve again. At present, there is no ideal solution for the expansion of the balloon clinically, and it can only be adjusted according to the doctor's operating feel.

Therefore, there is an urgent need for a new catheter that can precisely adjust the direction of balloon expansion to solve this clinical problem. Make the balloon expand in the direction of pre-set distraction and reset, gradually prop up the collapsed vertebral body until it returns to the clinical treatment requirements, and form a cavity for filling in bone cement and other bone fillers, avoiding Aggravate the degree of fracture injury at the broken part and the PVP vertebral body directional expansion balloon device that causes re-fracture.

Contents of the invention

In view of this, the present invention provides a method to expand the balloon to the preset direction of expansion and reduction, gradually prop up the collapsed vertebral body until it returns to the clinical treatment requirements, and form a cavity that can be filled for filling. Bone fillers such as bone cement should be inserted to avoid aggravating the degree of fracture injury at the broken site and the PVP vertebral body directional expansion balloon device that causes re-fracture.

To achieve the above object, the present invention provides the following technical solutions:

A PVP vertebral body directional dilation balloon device, comprising a catheter and a guide rod, one end of the catheter is connected with a Y-shaped connector, the other end of the catheter is connected with a balloon, and one end of the guide rod is sequentially passed through a joint of the Y-connector and the catheter extending rearwardly into the balloon, further comprising:

A rotating assembly, the rotating assembly is sheathed on the outside of the catheter, the rotating assembly includes a fixed sleeve and a blocking piece arranged on the fixed sleeve, the blocking piece is located on the balloon On the outside, the blocking piece is used to cover at least one pre-blocking position, wherein the blocking piece includes:

A blocking piece, the blocking piece is fixedly arranged on the fixed sleeve, rotating the fixed sleeve can make the blocking piece cover a pre-blocking position;

and at least one baffle piece 2, the baffle piece 2 is movably arranged on the outer periphery of the fixed sleeve, and the baffle piece 2 is moved along the circumferential direction of the fixed sleeve, so that the said baffle piece 2 can cover at least Another pre-blocking part;

Magnesium alloy stent, the surface of the magnesium alloy stent has a calcium-phosphorus coating. When in use, the balloon is put into the magnesium alloy stent, the magnesium alloy stent is closed into a rope shape, and the magnesium alloy stent After the stent is placed into the cavity available for filling formed by the expansion of the vertebral body, the balloon in the magnesium alloy stent is expanded, so that the magnesium alloy stent is expanded to form a balloon shape.

Further, a connecting rod is provided at the tail of the blocking piece 2, and a clamping block is provided at the tail of the connecting rod, and the clamping block is movably arranged on the outer circumference of the fixed sleeve, and the clamping block passes through the connecting rod The blocking piece 2 can be driven to move along the circumferential direction of the fixed sleeve.

Furthermore, the outer peripheral surface of the fixed sleeve is provided with a plurality of locking grooves which are slidably connected with the locking block.

Furthermore, the card slot is in a zigzag shape.

The present invention also provides a manufacturing method of a PVP vertebral body directional expansion balloon device, comprising the following steps:

Step S01, adding raw materials into the injection molding machine, injecting the melted raw materials into the mold of the Y-shaped connector, cooling for 10 to 15 minutes, opening the mold, taking out the blank of the Y-shaped connector, and expanding the Y-shaped connection with a hole expander The connection hole of the joint of the connector, use the chamferer to chamfer the connection hole of the joint of the Y-shaped connector;

Step S02, adding raw materials into the injection molding machine, injecting the raw materials into the mold of the fixed sleeve after melting, cooling for 5 minutes to 8 minutes, opening the mold, taking out the blank of the fixed sleeve, and expanding the inside of the fixed sleeve with a hole expander Hole, use a slotting device to open a slot on the fixed sleeve, and mill the front end of the fixed sleeve to form a stopper one;

Step S03, cut a thin tube, use a chamfer to remove the burr at the orifice of the thin tube to form a catheter, take a balloon, set the opening of the balloon on one end of the catheter, install it in a hot pressing mold, pressurize and heat Then take it out and cool it, the heating temperature is 130℃～195℃, the pressure is 0.5MPa～0.85MPa, the holding time is 1 minute to 2 minutes, and the cooling cycle time is 2 minutes to 3 minutes;

Step S04, set the other end of the conduit in a joint of the Y-shaped connector, install it in a hot pressing mold, pressurize and heat it, take it out and cool it, the heating temperature is 190°C-225°C, and the pressure is 0.8MPa-0.95 MPa, the holding time is 2 minutes to 5 minutes, and the cooling cycle time is 2 minutes to 5 minutes;

Step S05, passing one end of the guide rod sequentially through a joint of the Y-shaped connector and the catheter, and then extending into the balloon;

Step S06, installing a protective steel sheath on the balloon, passing the fixed sheath through the protective steel sheath, and removing the protective sheath after being installed on the catheter;

Step S07, engaging the clamping block in the clamping slot, and the second blocking piece is connected to the clamping block through a connecting rod.

Further, the cooling time in step S01 is 13 minutes.

Further, the cooling time in the step S02 is 6 minutes and 30 seconds.

Further, the heating temperature in the step S03 is 175° C., the pressure is 0.77 MPa, the holding time is 1 minute and 25 seconds, and the cooling cycle time is 2 minutes and 33 seconds.

Further, the heating temperature in the step S04 is 207° C., the pressure is 0.87 MPa, the holding time is 3 minutes and 52 seconds, and the cooling cycle time is 4 minutes.

It can be seen from the above-mentioned technical scheme that the advantage of the present invention is that the position of the stop piece at the front end of the fixed sleeve is adjusted by the knob, and the position of the stop piece two is adjusted by the position of the block moving in the slot, so that multiple A fracture site that cannot be distracted can be blocked, so that the balloon can expand to the preset direction of retraction and reset, so as not to aggravate the degree of fracture damage of the broken site and avoid re-fracture; by setting a scale on the outside of the catheter, The depth of balloon entry can be displayed.

In addition to the objects, features and advantages described above, the present invention has other objects, features and advantages. Hereinafter, the present invention will be described in further detail with reference to the drawings.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention. Those skilled in the art can also obtain other drawings based on these drawings without creative work. In the attached picture:

Fig. 1 is a structural schematic diagram of the present invention.

FIG. 2 is a partially enlarged schematic diagram of FIG. 1 .

Fig. 3 is a schematic diagram of the connection relationship between the locking block, the blocking piece 2 and the locking slot of the present invention.

Fig. 4 is a schematic diagram of the connection between the knob and the fixing sleeve of the present invention.

Marked in the figure: 1 is the catheter, 2 is the Y-shaped connector, 3 is the balloon, 4 is the guide rod, 5 is the block, 6 is the fixed sleeve, 7 is the block piece, 71 is the block one, 72 73 is a connecting rod, 8 is a knob, 9 is a draw-in groove, 10 is a through hole, 11 is a developing ring, and 12 is a handle.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

Embodiment one

As shown in Figure 1, Figure 2, Figure 3 and Figure 4, a PVP vertebral body directional dilation balloon device includes a catheter 1, a Y-shaped connector 2, a balloon 3 and a guide rod 4, and one end of the catheter 1 A Y-shaped connector 2 is connected, the other end of the catheter 1 is connected to the balloon 3, and one end of the guide rod 4 is sequentially passed through a joint of the Y-shaped connector 2 and the catheter 1 and then extends to the The balloon 3 also includes a rotating assembly sleeved on the outside of the catheter 1. The rotating assembly includes a fixed sleeve 6, a blocking piece 7 arranged at the front end of the fixed sleeve 6, and a The knob 8 at the tail and the block 5 that is movably arranged on the outer periphery of the fixed sleeve 6, the blocking piece 7 is arranged on the outside of the balloon 3, and the blocking piece 7 is composed of a blocking piece 71, a plurality of blocking pieces two 72 and the connecting rod 73 that is located at the end of the blocking piece two 72 are formed, the block 5 drives the blocking piece two 72 to move through the connecting rod 73, column osteoporotic fractures, vertebroplasty, and the design of the expandable balloon 3 can be used. The expanded material is assumed to be used by young patients, the balloon 3 expands, the cancellous bone graft heals, the balloon 3 shrinks, and the local environment returns to the natural physiological state.

Preferably, the number of the second blocking piece 72 is 1-6.

Optimally, the number of the second blocking piece 72 is two.

The outer peripheral surface of the fixed sleeve 6 is provided with a card slot 9 for the sliding connection of the block 5, and the card slot 9 is in a zigzag structure, and the catheter 1 is provided with a scale, which can display the ball The depth that the capsule 3 enters, the first stopper 71 is fixedly arranged on the front end of the fixed sleeve 6, and the first stopper 71 is a hollow structure, the knob 8 is provided with a There are through holes 10 connected to the passages of the balloon 3, and two development rings 11 are arranged on the upper ring of the guide rod 4 in the cavity of the balloon 3. The development rings 11 are made of radiopaque materials. When in use, the development rings 11 The specific position of the balloon 3 can be determined under the CT machine, the tail of the Y-shaped connector 2 is provided with a handle 12, and the handle 12 is fixedly connected with the other end of the guide rod 4 by threads. The guide rod can be firmly placed in the conduit, which plays a better role in supporting the entire structure. The knob 8 is provided with anti-skid lines to increase the friction between the hand and the knob, so that the entire blocking piece can be better rotated to the desired position. desired location.

The PVP vertebral body directional dilation balloon device also includes a magnesium alloy stent, the surface of the magnesium alloy stent has a calcium-phosphorus coating, and when in use, the balloon 3 is put into the magnesium alloy stent, and the magnesium alloy The alloy stent is closed into a cord shape, and after the magnesium alloy stent is placed into the cavity formed by the expansion of the vertebral body for filling, the balloon 3 in the magnesium alloy stent is expanded, so that the magnesium alloy stent is expanded form a balloon.

In the PVP vertebral body directional dilation balloon device provided by the present invention, a rotating assembly composed of a block 5, a fixed sleeve 6, a blocking piece 7 and a knob 8 is installed on the outside of the catheter 1, and the knob 8 can drive the entire blocking piece. When the piece 7 rotates, the block 5 can drive the second baffle 72 to rotate, so that the balloon 3 can expand toward the preset direction of stretching and resetting, so as not to aggravate the degree of fracture damage of the broken part and avoid causing Further fracture, further, by providing a scale on the outside of the catheter 1, the depth of entry of the balloon 3 can be displayed, and further, the knob 8 is provided with anti-slip lines to increase the friction between the hand and the knob, so that it can It is better to rotate the entire blocking piece to the desired position. Further, two developing rings 11 are arranged around the guide rod in the cavity of the balloon. The developing rings 11 are made of radiopaque materials. The development ring 11 can determine the specific position of the balloon under the CT machine. Further, the tail of the Y-shaped connector 2 is provided with a handle 12 for the fastening connection of the guide rod, and the joint end of the handle 12 and the Y-shaped connector 2 is threaded. connection, such a setting can securely place the guide rod in the catheter, which plays a better supporting role for the whole structure. Further, the magnesium alloy stent is located on the outside of the balloon 3 to expand the magnesium alloy The balloon 3 in the stent makes the magnesium alloy stent expand to form a balloon to compress the fracture and reset it.

The balloon 3 can be expanded and has a certain strength; the balloon 3 has a magnesium alloy stent, and the surface of the magnesium alloy stent has a calcium-phosphorus coating, so that the magnesium alloy stent can be absorbed, and when the magnesium alloy stent is closed, It has a mesh structure, and after expansion, it forms a balloon shape and stays in the injured part to play a role of fixation and support. The magnesium alloy stent can be filled with cancellous bone or bone cement, so the balloon 3 with the magnesium alloy stent not only It can realize the effect of repairing bone defect in vivo, and has excellent mechanical properties.

The use method of the vertebral body expansion balloon catheter provided by the present invention is: during the operation, the fixing sleeve 6 is inserted into the fractured vertebral body through the passage drilled in advance, and the head of the fixing sleeve 6 is adjusted through the knob 8 The position of the block piece 7, and the position of the block piece 2 72 is adjusted by the position of the block 5 moving in the slot 9, so that a plurality of fracture sites that cannot be stretched can be blocked, and the ball on the catheter can be blocked. After the balloon 3 extends from the fixed sleeve 6 to the fracture site that needs to be retracted, a certain volume of contrast agent is injected into the balloon 3 through another interface on the Y-shaped connector 2 to pressurize it to expand, so that the balloon 3 Expand toward the pre-set direction of expansion and reduction, gradually prop up the collapsed vertebral body until it returns to the clinical treatment requirements, and form a cavity for filling in bone cement and other bone fillers, and then place the The balloon 3 is contracted and taken out, and then the balloon 3 with the magnesium alloy stent on the catheter is re-inserted from the fixed sleeve 6 to the fracture site that needs to be retracted, and a certain volume of contrast agent is injected into the balloon 3 Pressurize to make it expand, and then expand the magnesium alloy stent to form a balloon shape, which plays a role of support and fixation, so that the degree of fracture damage at the broken part will not be aggravated, and re-fracture will be avoided, and the balloon 3 will be placed again Shrink and take it out, the balloon-shaped magnesium alloy stent stays inside, because the magnesium alloy stent has a certain strength, it can temporarily play the role of stent to fix the fracture, and then fill the bone cement or cancellous bone in the magnesium alloy stent bone, since the magnesium alloy scaffold can be absorbed, the bone graft heals after the magnesium alloy scaffold is degraded and dissolved.

Embodiment two

The manufacture method of the PVP vertebral body directional expansion balloon device as shown in Figure 1, Figure 2, Figure 3 and Figure 4, comprises the following steps:

Step S01, adding raw materials into the injection molding machine, injecting the melted raw materials into the mold of the Y-shaped connector 2, cooling for 10 to 15 minutes, opening the mold, taking out the blank of the Y-shaped connector 2, and enlarging the Y shape with a hole expander. The connection hole of the joint of the Y-shaped connector 2, the connection hole orifice of the joint of the Y-shaped connector 2 is chamfered with a chamferer;

Optimally, the cooling time in step S01 is 13 minutes.

Step S02, adding raw materials into the injection molding machine, injecting the raw materials into the mold of the fixed sleeve 6 after melting, cooling for 5 minutes to 8 minutes, opening the mold, taking out the blank of the fixed sleeve 6, and expanding the fixed sleeve with a hole expander 6, use a slotting device to open a slot 9 on the fixed sleeve 6, the slot 9 is located on the outer circumference of the fixed sleeve 6, and the front end of the fixed sleeve 6 is milled to form a stopper 71;

Preferably, the cooling in step S02 is 6 minutes and 30 seconds.

Step S03, cut a thin tube, use a chamferer to remove the burr at the orifice of the thin tube to form a catheter 1, take the balloon 3, set the opening of the balloon 3 on one end of the catheter 1, and install it in a hot pressing mold, After pressurizing and heating, take it out and cool it, the heating temperature is 130℃～195℃, the pressure is 0.5MPa～0.85MPa, the holding time is 1 minute to 2 minutes, and the cooling cycle time is 2 minutes to 3 minutes;

Preferably, the heating temperature in step S03 is 175° C., the pressure is 0.77 MPa, the dwell time is 1 minute and 25 seconds, and the cooling cycle time is 2 minutes and 33 seconds.

Step S04, set the other end of the conduit 1 in a joint of the Y-shaped connector 2, install it in a hot pressing mold, pressurize and heat it, take it out and cool it, the heating temperature is 190°C-225°C, and the pressure is 0.8MPa ～0.95MPa, the holding time is 2 minutes to 5 minutes, and the cooling cycle time is 2 minutes to 5 minutes;

Preferably, the heating temperature in step S04 is 207° C., the pressure is 0.87 MPa, the dwell time is 3 minutes and 52 seconds, and the cooling cycle time is 4 minutes.

Step S05, passing one end of the guide rod 4 sequentially through a joint of the Y-shaped connector 2 and the catheter 1, and then extending into the balloon 3;

Step S06, installing a protective steel sheath on the balloon 3, passing 6 sets of fixed sleeves through the protective steel sheath, and after installing it on the catheter 1, removing the protective steel sheath;

Step S07 , engaging the clamping block 5 in the clamping slot 9 , and the blocking piece 2 72 is connected to the clamping block 5 through the connecting rod 73 .

The above-mentioned cooling adopts air cooling, so that the deformation speed is slow and cracks are avoided.

The balloon 3 can be expanded and has a certain strength; the balloon 3 has a magnesium alloy stent, and the surface of the magnesium alloy stent has a calcium-phosphorus coating, so that the magnesium alloy stent can be absorbed, and when the magnesium alloy stent is closed, It has a net-like structure, and after expansion, it stays at the damaged site as a new balloon to play a role in fixing and supporting. The magnesium alloy stent can be filled with cancellous bone or bone cement, so the balloon 3 with the magnesium alloy stent not only It can realize the effect of repairing bone defect in vivo, and has excellent mechanical properties.

Embodiment three

As shown in Fig. 1, Fig. 2, Fig. 3 and Fig. 4, a kind of PVP vertebral body directional dilatation balloon device comprises catheter 1 and guide rod 4, and one end of described catheter 1 is connected with Y-shaped connector 2, and described The other end of the catheter 1 is connected to a balloon 3, and one end of the guide rod 4 is sequentially passed through a joint of the Y-shaped connector 2 and the catheter 1 and then extends into the balloon 3. Two development rings 11 are arranged on the upper ring of the guide rod 4 of the cavity of the balloon 3, and the development rings 11 are made of radiopaque materials. During use, the development rings 11 can determine the specific position of the balloon under the CT machine, and also Including a rotating assembly, the rotating assembly is sleeved on the outside of the catheter 1, the rotating assembly includes a fixed sleeve 6 and a blocking piece 7 arranged on the fixed sleeve 6, the blocking piece 7 Located on the outside of the balloon 3 , the blocking piece 7 is used to cover at least one pre-blocking position, and the catheter 1 is provided with a scale for displaying the penetration depth of the balloon 3 .

The blocking piece 7 includes a blocking piece one 71 and at least one blocking piece two 72, the blocking piece one 71 is fixedly arranged on the front end of the fixed sleeve 6, and the blocking piece one 71 is a hollow structure, Rotating the fixed sleeve 6 can make the first blocking piece 71 cover a pre-blocking position, so as to facilitate the adjustment of the blocking position; the second blocking piece 72 is movably arranged on the outer periphery of the fixed sleeve 6, along the Moving the second blocking piece 72 in the circumferential direction of the tube 6 can make the second blocking piece 72 cover at least another pre-blocking position, so as to facilitate the adjustment of the blocking position; the first blocking piece 71 is used in conjunction with the second blocking piece 72 A plurality of fracture sites that cannot be distracted can be blocked, so that the balloon 3 can expand to the preset direction of retraction and reset, so as not to aggravate the degree of fracture damage of the broken site and avoid causing re-fracture. The afterbody of two 72 is provided with connecting rod 73, and the afterbody of described connecting rod 73 is provided with clamping block 5, and described clamping block 5 is movably arranged on the outer periphery of described fixed sleeve 6, and described clamping block 5 passes connecting rod 73 can drive the stopper 2 72 to move along the circumferential direction of the fixed sleeve 6, column osteoporosis fracture, vertebroplasty, the design of the absorbable expandable balloon 3, using absorbable and expandable materials, It is assumed that the user population is young patients, the balloon 3 expands, the cancellous bone graft heals, the balloon 3 contracts, and the local environment returns to a natural physiological state.

Preferably, the number of the second blocking piece 72 and the locking block 5 is 1-6.

Optimally, there are two blocking pieces 72 and two blocks 5 .

The outer peripheral surface of the fixed sleeve 6 is provided with a plurality of slots 9 slidingly connected with the block 5, and the slots 9 are serrated, and the tail of the fixed sleeve 6 is provided with a knob 8. The knob 8 is provided with a through hole 10 communicating with the channel in the fixed sleeve 6, and the knob 8 is provided with anti-skid lines to increase the friction between the hand and the knob, so that it can be rotated better the entire blank piece into the desired position.

Preferably, the number of the card slots 9 is 1-6.

Optimally, the number of the card slots 9 is two.

The tail of the Y-shaped connector 2 is provided with a handle 12, and the handle 12 is fixedly connected to the other end of the guide rod 4, so that the guide rod can be firmly placed in the catheter, which has played a better role in this whole structure. supporting role.

The PVP vertebral body directional dilation balloon device also includes a magnesium alloy stent, the surface of the magnesium alloy stent has a calcium-phosphorus coating, and when in use, the balloon 3 is put into the magnesium alloy stent, and the magnesium alloy The alloy stent is closed into a cord shape, and after the magnesium alloy stent is placed into the cavity formed by the expansion of the vertebral body for filling, the balloon 3 in the magnesium alloy stent is expanded, so that the magnesium alloy stent is expanded form a balloon.

In the PVP vertebral body directional dilation balloon device provided by the present invention, a rotating assembly composed of a block 5, a fixed sleeve 6, a blocking piece 7 and a knob 8 is installed on the outside of the catheter 1, and the knob 8 can drive the entire blocking piece. When the piece 7 rotates, the block 5 can drive the second baffle 72 to rotate, so that the balloon 3 can expand toward the preset direction of stretching and resetting, so as not to aggravate the degree of fracture damage of the broken part and avoid causing Further fracture, further, by providing a scale on the outside of the catheter 1, the depth of entry of the balloon 3 can be displayed, and further, the knob 8 is provided with anti-slip lines to increase the friction between the hand and the knob, so that it can It is better to rotate the entire blocking piece to the desired position. Further, two developing rings 11 are arranged around the guide rod in the cavity of the balloon. The developing rings 11 are made of radiopaque materials. The development ring 11 can determine the specific position of the balloon under the CT machine. Further, the tail of the Y-shaped connector 2 is provided with a handle 12 for the fastening connection of the guide rod, and the joint end of the handle 12 and the Y-shaped connector 2 is threaded. connection, such a setting can securely place the guide rod in the catheter, which plays a better supporting role for the whole structure. Further, the magnesium alloy stent is located on the outside of the balloon 3 to expand the magnesium alloy The balloon 3 in the stent makes the magnesium alloy stent expand to form a balloon to compress the fracture and reset it.

The balloon 3 can be expanded and has a certain strength; the balloon 3 has a magnesium alloy stent, and the surface of the magnesium alloy stent has a calcium-phosphorus coating, so that the magnesium alloy stent can be absorbed, and when the magnesium alloy stent is closed, It has a mesh structure, and after expansion, it forms a balloon shape and stays in the injured part to play a role of fixation and support. The magnesium alloy stent can be filled with cancellous bone or bone cement, so the balloon 3 with the magnesium alloy stent not only It can realize the effect of repairing bone defect in vivo, and has excellent mechanical properties.

The use method of the vertebral body expansion balloon catheter provided by the present invention is: during the operation, the fixing sleeve 6 is inserted into the fractured vertebral body through the passage drilled in advance, and the head of the fixing sleeve 6 is adjusted through the knob 8 The position of the block piece 7, and the position of the block piece 2 72 is adjusted by the position of the block 5 moving in the slot 9, so that a plurality of fracture sites that cannot be stretched can be blocked, and the ball on the catheter can be blocked. After the balloon 3 extends from the fixed sleeve 6 to the fracture site that needs to be retracted, a certain volume of contrast agent is injected into the balloon 3 through another interface on the Y-shaped connector 2 to pressurize it to expand, so that the balloon 3 Expand toward the pre-set direction of expansion and reduction, gradually prop up the collapsed vertebral body until it returns to the clinical treatment requirements, and form a cavity for filling in bone cement and other bone fillers, and then place the The balloon 3 is contracted and taken out, and then the balloon 3 with the magnesium alloy stent on the catheter is re-inserted from the fixed sleeve 6 to the fracture site that needs to be retracted, and a certain volume of contrast agent is injected into the balloon 3 Pressurize to make it expand, and then expand the magnesium alloy stent to form a balloon shape, which plays a role of support and fixation, so that the degree of fracture damage at the broken part will not be aggravated, and re-fracture will be avoided, and the balloon 3 will be placed again Shrink, take out, and the balloon-shaped magnesium alloy stent stays inside. Because the magnesium alloy stent has a certain strength, it can temporarily play the role of stent to fix the fracture, and then fill the bone cement or cancellous substance in the magnesium alloy stent bone, since the magnesium alloy scaffold can be absorbed, the bone graft heals after the magnesium alloy scaffold is degraded and dissolved.

A method for manufacturing a PVP vertebral body directional expansion balloon device, comprising the following steps:

Step S01, adding raw materials into the injection molding machine, injecting the melted raw materials into the mold of the Y-shaped connector 2, cooling for 10 to 15 minutes, opening the mold, taking out the blank of the Y-shaped connector 2, and enlarging the Y shape with a hole expander. The connection hole of the joint of the Y-shaped connector 2, the connection hole orifice of the joint of the Y-shaped connector 2 is chamfered with a chamferer;

Optimally, the cooling time in step S01 is 13 minutes.

Step S02, adding raw materials into the injection molding machine, injecting the raw materials into the mold of the fixed sleeve 6 after melting, cooling for 5 minutes to 8 minutes, opening the mold, taking out the blank of the fixed sleeve 6, and expanding the fixed sleeve with a hole expander 6, use a slotting device to open a slot 9 on the fixed sleeve 6, the slot 9 is located on the outer circumference of the fixed sleeve 6, and the front end of the fixed sleeve 6 is milled to form a stopper 71;

Preferably, the cooling in step S02 is 6 minutes and 30 seconds.

Step S03, cut a thin tube, use a chamferer to remove the burr at the orifice of the thin tube to form a catheter 1, take the balloon 3, set the opening of the balloon 3 on one end of the catheter 1, and install it in a hot pressing mold, After pressurizing and heating, take it out and cool it, the heating temperature is 130℃～195℃, the pressure is 0.5MPa～0.85MPa, the holding time is 1 minute to 2 minutes, and the cooling cycle time is 2 minutes to 3 minutes;

Preferably, the heating temperature in step S03 is 175° C., the pressure is 0.77 MPa, the dwell time is 1 minute and 25 seconds, and the cooling cycle time is 2 minutes and 33 seconds.

Step S04, set the other end of the conduit 1 in a joint of the Y-shaped connector 2, install it in a hot pressing mold, pressurize and heat it, take it out and cool it, the heating temperature is 190°C-225°C, and the pressure is 0.8MPa ～0.95MPa, the holding time is 2 minutes to 5 minutes, and the cooling cycle time is 2 minutes to 5 minutes;

Preferably, the heating temperature in step S04 is 207° C., the pressure is 0.87 MPa, the dwell time is 3 minutes and 52 seconds, and the cooling cycle time is 4 minutes.

Step S05, passing one end of the guide rod 4 sequentially through a joint of the Y-shaped connector 2 and the catheter 1, and then extending into the balloon 3;

Step S06, installing a protective steel sheath on the balloon 3, passing 6 sets of fixed sleeves through the protective steel sheath, and after installing it on the catheter 1, removing the protective steel sheath;

Step S07 , engaging the clamping block 5 in the clamping slot 9 , and the blocking piece 2 72 is connected to the clamping block 5 through the connecting rod 73 .

The above-mentioned cooling adopts air cooling, so that the deformation speed is slow and cracks are avoided.

The above are only preferred embodiments of the present invention, and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and changes. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims (9)

1. a kind of PVP vertebral oriented dilated balloon-system, including conduit (1) and guide rod (4), one end connection of the conduit (1) Have Y-connection (2), the other end of the conduit (1) is connected with sacculus (3), and one end of the guide rod (4) is successively fed through institute It is extended in the sacculus (3) after stating a connector and the conduit (1) for Y-connection (2), which is characterized in that further include:

One rotary components, the rotary components are set in the outside of the conduit (1), and the rotary components include fixed sleeving (6) and be set to the fixed sleeving (6) on baffle part (7), the baffle part (7) is located at the outside of the sacculus (3), described Baffle part (7) is for sheltering from least one pre- stopper position, wherein the baffle part (7) includes:

One baffle one (71), the baffle one (71) are fixed on the fixed sleeving (6), rotate the fixed sleeving (6), baffle one (71) can be made to shelter from a pre- stopper position；

With at least one baffle two (72), the baffle two (72) is movably arranged on the periphery of the fixed sleeving (6), along institute The mobile baffle two (72) of circumferential direction for stating fixed sleeving (6), can make the baffle two (72) shelter from least another pre- stopper Position；

Magnesium alloy bracket, the magnesium alloy bracket surface has calcium phosphor coating, in use, the sacculus (3) is put into the magnesium In alloy bracket, the magnesium alloy bracket is closed into it is streak, by the magnesium alloy bracket be put into centrum by expansion formed After the cavity of filling, the sacculus (3) in the magnesium alloy bracket is expanded, so that the magnesium alloy bracket to form ball by expanding Cryptomere.

2. PVP vertebral oriented dilated balloon-system according to claim 1, which is characterized in that the baffle two (72) Tail portion is equipped with connecting rod (73), and the tail portion of the connecting rod (73) is equipped with fixture block (5), and the fixture block (5) is movably arranged on described On the periphery of fixed sleeving (6), and the fixture block (5) can drive the baffle two (72) along the fixation by connecting rod (73) The circumferential movement of casing (6).

3. PVP vertebral oriented dilated balloon-system according to claim 2, which is characterized in that the fixed sleeving (6) Several card slots (9) being slidably connected with the fixture block (5) are equipped on outer circumference surface.

4. PVP vertebral oriented dilated balloon-system according to claim 3, which is characterized in that the card slot (9) is in sawtooth Shape.

5. a kind of manufacturing method of PVP vertebral oriented dilated balloon-system, which comprises the following steps:

Step S01, the adding raw materials into injection molding machine are 10 points cooling after raw material melting in injection molding to the mold of Y-connection (2) Clock~15 minute, opening mold take out the blank of Y-connection (2), expand the company of the connector of Y-connection (2) with reamer Hole is connect, falls the connecting hole aperture of the connector of Y-connection (2) with chamfering device；

Step S02, the adding raw materials into injection molding machine are 5 minutes cooling after raw material melting in injection molding to the mold of fixed sleeving (6) ~8 minutes, opening mold took out the blank of fixed sleeving (6), expands the inner hole of fixed sleeving (6) with reamer, was filled with fluting It sets and opens fabrication slot (9) on fixed sleeving (6), the preceding end milling of fixed sleeving 6 is formed into baffle one (71)；

Step S03 intercepts a section tubule, removes tubule aperture burr with chamfering device, is formed conduit (1), sacculus (3) are taken, by ball The opening of capsule (3) is set in one end of conduit (1), in hot pressing die, takes out cooling after pressurization, heating, heating temperature is 130 DEG C~195 DEG C, pressure is 0.5MPa~0.85MPa, and the dwell time is 1 minute~2 minutes, and the cooling cycle time is 2 minutes ~3 minutes；

The other end of conduit (1) is set in a connector of Y-connection (2) by step S04, in hot pressing die, is added Cooling is taken out after pressure, heating, heating temperature is 190 DEG C~225 DEG C, and pressure is 0.8MPa~0.95MPa, and the dwell time is 2 points Clock~5 minute, cooling cycle time are 2 minutes~5 minutes；

One end of guide rod (4) is successively fed through the connector and the conduit (1) of the Y-connection (2) by step S05 After extend in the sacculus (3)；

Step S06 loads onto protection steel bushing on sacculus (3), and fixed sleeving (6) set is passed through from protection steel bushing, is mounted in conduit (1) after on, remove protection steel bushing；

Fixture block (5) is fastened in card slot (9) by step S07, and the baffle two (72) is connected to fixture block by connecting rod (73) (5) on.

6. manufacturing method according to claim 5, which is characterized in that the cooling time in the step S01 is 13 minutes.

7. manufacturing method according to claim 5, which is characterized in that the cooling time in the step S02 is 6 minutes 30 Second.

8. manufacturing method according to claim 5, which is characterized in that the heating temperature in the step S03 is 175 DEG C, Pressure is 0.77MPa, and the dwell time is 25 seconds 1 minute, and the cooling cycle time is 33 seconds 2 minutes.

9. manufacturing method according to claim 5, which is characterized in that the heating temperature in the step S04 is 207 DEG C, Pressure is 0.87MPa, and the dwell time is 52 seconds 3 minutes, and the cooling cycle time is 4 minutes.