Patent Description:
Existing percutaneous kyphoplasty PKP is a procedure involves inserting an inflatable balloon into a collapsed vertebral body through percutaneous puncture, raising an endplate through the expansion of the balloon, restoring the height of the vertebral body, correcting the kyphosis, forming a cavity surrounded by a bone shell inside the vertebral body, and injecting high viscosity bone cement under a low pressure. In order to make the balloon enter the vertebral body smoothly, a working channel needs to be created with a puncture needle and a sleeve, then a working channel for the balloon before its expansion is drilled by using a bone drill, the balloon is sent into the vertebral body, and the balloon is withdrawn after a cavity surrounded by a bone shell is formed inside the vertebral body, the bone cement is finally injected. The operation procedures are quite complex. In addition, due to the structure of the vertebral body, in order to maintain the biomechanical force balance of the vertebral body, balloon expansion needs to be performed on both sides of each vertebral body and the bone cement needs to be injected therein. All operations need to be operated under X-ray monitoring. As a result, the more complex the operation, the longer time the operation, the greater damage to the doctor's health, and the higher the requirements for doctor's physical strength and professional skills; balloon expansion and injection of bone cement on both sides will cause great trauma to the patient and a higher chance of complications for the patient; moreover, it may increase an economic burden on the patient. All of the above-mentioned disadvantages are quite obvious in the case of lesions of multiple vertebral bodies.

Chinese Patent Application No. <CIT> discloses an integrated and multifunctional vertebral body former, comprising a balloon assembly, an angled adjustment assembly and an angled cavity opening assembly, but does not disclose in detail the connection relationship and working modes of various components at a proximal end to achieve multiple functions.

Chinese Patent Application No. <CIT> and <CIT> disclose a multifunctional vertebral body former, comprising a balloon assembly and a cavity opening assembly. An outer tube assembly in the cavity opening assembly comprises an outer tube and an outer tube handle. The outer tube has an axial rigidity capable of withstanding a trust load from the opening of cavity for a tissue without deforming. The outer tube handle is provided with a cavity interface for injection of bone cement. However, it does not disclose details about the connection relationship and working modes for various components at a proximal end to achieve multiple functions.

Therefore, there's an urgent need for a vertebral body former which is easy to operate and simple in structure, so as to achieve the versatility of the vertebral body former.

In order to solve the above-mentioned disadvantages in the prior art, the present invention provides a vertebral body former which is simple in structure and easy to operate. Expansion of a bone drill and pre-expansion of a balloon catheter are integrated in one instrument. In this way, the operation is simplified, operation time is reduced, operation efficiency is improved. In addition, since the operation needs to be performed under X-ray monitoring, shortening the operation time helps to reduce the damage to a doctor's health, and to reduce requirements for the doctor's physical strength and operational requirements.

For achieving the above-mentioned purposes, the invention adopts the following technical solution:
a multifunctional vertebral body former, comprising:.

Preferably, the balloon structure further comprises a balloon deliver snap fitting sleeved outside of the balloon delivery snap, a second clamping lug at a distal end of the balloon delivery snap is inserted into a sliding chute of an inner surface of the balloon deliver snap fitting, a distal end of the sliding chute is provided with a slot; a distal end of the balloon deliver snap fitting is detachably connected with a limiting member sleeved outside of the slider by a snap; an inner rounded edge at a distal end of the limiting member extends a plurality of arc-shaped portions which are not connected with each other along an outer surface of the slider in a direction towards the distal end, a distal end of each of the plurality of arc-shaped portions are fixed to a proximal end of an end cap by a cylindrical pin, the end cap is match with and locked to a sleeve handle by a locking ring; the outer tube adjusting handle is sleeved outside of the arc-shaped portions, the threaded structure on the outer surface of the slider extends beyond a gap of the arc-shaped portions, and matches with the internal threaded structure of the outer tube adjusting handle.

Preferably, the locking ring is sleeved on an area external to a distal end of the end cap, a top block is sleeved between the distal end of the end cap and the locking ring , and is in threaded connection with the distal end of the end cap; a proximal end of the locking ring is fixed to the top block through the end cap, the proximal end of the locking ring can rotate about the end cap, and a distal end of the locking ring is fixed with the sleeve handle by the snap.

Preferably, the outer tube is sleeved on the exterior of the shape memory alloy tube, the outer tube and the end cap are integrally injection molded.

Since the outer tube has certain rigidity, it facilitates a distal end of the vertebral body former to enter into a specific position between vertebral bodies. When the distal end of the released shape memory alloy tube has a certain bending angle, it can be withdrawn into the outer tube before being withdrawn into the sleeve.

Preferably, a proximal end of the balloon handle extends a protrusion relative to a proximal end of the balloon handle fitting and a proximal end of the balloon delivery snap, a proximal end surface of the protrusion is closed to form a cavity, a side wall of the protrusion is provided with a cavity interface; the balloon outer tube is in communication with the outside through the protrusion.

Furthermore, the outside of the proximal end surface of the protrusion is connected to a supporting wire seat through a screw thread, the supporting wire seat is fixedly connected with a proximal end of the supporting wire, the supporting wire is inserted into a pore channel at the proximal end surface of the protrusion, the balloon outer tube and the balloon in sequence, and finally, a distal end surface of the supporting wire is in contact with the distal end of the balloon.

The supporting wire is made of a plastic material, so when the shape memory alloy tube has a certain bending angle, a force on the supporting wire is applied to make it bent, so that the distal end of the whole balloon structure is bent, and the bending angle is equal to that of the shape memory allot tube.

Preferably, a balloon inner tube is bonded to the balloon handle with the medical grade glue; the balloon handle fitting is bonded to the balloon handle with medical grade glue.

Preferably, a balloon inner tube is further provided or not provided between the balloon outer tube and the supporting wire, a proximal end of the balloon inner tube is fixed to the pore channel on the proximal end surface of the protrusion, a distal end of the balloon inner tube is contacted with the distal end of the balloon.

Furthermore, the balloon inner tube is not provided, the balloon outer tube is inserted from the proximal end of the balloon into the distal end of the balloon, both the proximal end and the distal end of the balloon are welded to the balloon outer tube by sweat soldering or laser welding; an opening is provided on the balloon outer tube in an interior of the balloon; the balloon outer tube at the distal end of the balloon is sealed with UV adhesives or PU rods.

Furthermore, in an embodiment where the balloon inner tube is provided, the distal end of the balloon inner tube is welded to the distal end of the balloon by sweat soldering or laser welding, and they are sealed in the balloon inner tube by the UV adhesives, and the supporting wire is in contact with the UV adhesives.

Furthermore, in an embodiment where the balloon inner tube is provided, the distal end of the balloon is welded to the balloon inner tube through a transition tube by sweat soldering or laser welding; after a proximal end of a plug is welded to the distal end of the supporting wire by laser welding, the proximal end of a plug and the distal end of the balloon are bonded to and sealed with the medical grade glue.

Preferably, a reinforcing tube is also sleeved on an outer surface of the balloon outer tube, and the reinforcing tube is bonded to the balloon outer tube with the medical grade glue, and the reinforcing tube and the balloon handle fitting are integrally injection molded.

The balloon outer tube is made of a PU material, so it is relatively softer. The reinforcing tube functions as: (<NUM>) protecting the balloon outer tube; and (<NUM>) making it easier to feed the balloon due to the rigidity of the reinforcing tube.

Preferably, a section of a curved portion is provided at the distal end of the shape memory alloy tube; the balloon is located at an interior of the shape memory alloy tube in its initial state. In this way, the distal end of the shape memory alloy tube is sealed, to some extent, so that cancellous bone inside the vertebral body can be prevented from entering the shape memory alloy tube during the process of vertebral expansion. The vertebral expansion herein refers to a process in which a head end of the shape memory alloy tube squeezes the cancellous bone inside the vertebral body to form a balloon passage.

By adopting the above-mentioned technical solutions, the present invention has the beneficial effects over the prior art:.

Reference numerals in the accompanying drawings:.

For better understanding of the invention, the present invention will be described clearly and fully hereinafter with reference to the particular embodiments, but the invention is not limited thereto.

In the following examples, a proximal end refers to a direction close to an operator, and a distal end refers to a direction close to a patient; clockwise refers to the clockwise direction relative to the operator, and counterclockwise refers to the counterclockwise direction relative to the operator.

The embodiment of the invention provides a multifunctional vertebral body former, as shown in <FIG> and <FIG>, comprising:.

In this embodiment, as shown in <FIG>, <FIG>, the balloon structure <NUM> further comprises a balloon deliver snap fitting <NUM> sleeved outside of the balloon delivery snap <NUM>, a second clamping lug <NUM> at a distal end of the balloon delivery snap <NUM> is inserted into a sliding chute <NUM> of an inner surface of the balloon deliver snap fitting <NUM>, a distal end of the sliding chute <NUM> is provided with a slot <NUM>; a distal end of the balloon deliver snap fitting <NUM> is detachably connected with a limiting member <NUM> sleeved outside of the slider <NUM> by a snap; an inner rounded edge at a distal end of the limiting member <NUM> extends a plurality of arc-shaped portions <NUM> which are not connected with each other along an outer surface of the slider <NUM> in a direction towards the distal end, a distal end of each of the plurality of arc-shaped portions <NUM> are fixed to a proximal end of an end cap <NUM> by a cylindrical pin <NUM>, the end cap <NUM> is match with and locked to a sleeve handle <NUM> by a locking ring <NUM>; the outer tube adjusting handle <NUM> is sleeved outside of the arc-shaped portions <NUM>, the threaded structure on the outer surface of the slider <NUM> extends beyond a gap of the arc-shaped portions <NUM>, and matches with the internal threaded structure of the outer tube adjusting handle <NUM>.

In this embodiment, the locking ring <NUM> is sleeved on an area external to a distal end of the end cap <NUM>, a top block <NUM> is sleeved between the distal end of the end cap <NUM> and the locking ring <NUM>, and is in threaded connection with the distal end of the end cap <NUM>; a proximal end of the locking ring <NUM> is fixed to the top block <NUM> through the end cap <NUM>, the proximal end of the locking ring <NUM> can rotate about the end cap <NUM>, and a distal end of the locking ring <NUM> is fixed with the sleeve handle <NUM> by the snap.

In this embodiment, as shown in <FIG>, <FIG>, the outer tube <NUM> is sleeved on the exterior of the shape memory alloy tube <NUM>, the outer tube <NUM> is formed integrally with the end cap <NUM> by injection molding. Since the outer tube <NUM> has certain rigidity, it facilitates a distal end of the vertebral body former to enter into a specific position between vertebral bodies. When the distal end of the released shape memory alloy tube <NUM> has a certain bending angle, it can be withdrawn into the outer tube <NUM> before being withdrawn into the sleeve <NUM>.

In this embodiment, as shown in <FIG>, a proximal end of the balloon handle <NUM> extends a protrusion <NUM> relative to a proximal end of the balloon handle fitting <NUM> and a proximal end of the balloon delivery snap <NUM>, a proximal end surface of the protrusion <NUM> is closed to form a cavity, a side wall of the protrusion <NUM> is provided with a cavity interface <NUM>; the balloon outer tube <NUM> is in communication with the outside through the protrusion <NUM>.

In this embodiment, as shown in <FIG>, <FIG>, <FIG>, the outside of the proximal end surface of the protrusion <NUM> is connected to a supporting wire seat <NUM> through a screw thread, the supporting wire seat <NUM> is fixedly connected with a proximal end of the supporting wire <NUM>, the supporting wire <NUM> is inserted into a pore channel <NUM> at the proximal end surface of the protrusion <NUM>, the balloon outer tube <NUM> and the balloon <NUM> in sequence, and finally, a distal end surface of the supporting wire <NUM> is in contact with the distal end of the balloon <NUM>; when the distal end of the supporting wire <NUM> is not provided with the plug <NUM> welded thereto, it can be separated from the supporting seat by rotating the supporting wire seat <NUM>, and then the whole supporting wire <NUM> is pulled out.

In an embodiment of the invention, in <FIG>, a section of a curved portion <NUM> is provided at the distal end of the shape memory alloy tube <NUM>; the balloon <NUM> is located at an interior of the shape memory alloy tube <NUM> in its initial state. In this way, the distal end of the shape memory alloy tube <NUM> is sealed, to some extent, so that cancellous bone inside the vertebral body can be prevented from entering the shape memory alloy tube <NUM> during the process of vertebral expansion. The vertebral expansion herein refers to a process in which a head end of the shape memory alloy tube squeezes the cancellous bone inside the vertebral body to form a balloon passage; preferably, the shape memory alloy tube itself is a memory metal, and the shape memory alloy tube can form a bending angle of <NUM>° after heat treatment through a shaping angle designed on a shaping die; the aim of the heat treatment is to reduce its Af point (the temperature when it returns to the cornered state) to obtain superelasticity, so the shape memory alloy tube can return to the cornered state by virtue of its own memory properties and the superelasticity obtained from the heat treatment after extending beyond the outer tube; furthermore, in this embodiment, after heat-setting the shape memory alloy tube by the heat treatment, the Af point is controlled at a temperature of about <NUM>, when a temperature is higher than the Af point, the shape memory alloy tube can quickly return to the cornered state. When the balloon passage is established, the shape memory alloy tube enters the inside of the vertebral body, and the temperature inside the human body is about <NUM>, so when the shape memory alloy tube comes out of a sleeve, it will create the balloon passage inside the vertebral body at a determined bending angel, so that the shape memory alloy tube can reach the opposite side of the vertebral body from a side of the vertebral body which has been punctured through the curved portion.

In this embodiment, the supporting wire <NUM> is made of semi-rigid material, which provides sufficient rigidity to the distal end of the balloon structure <NUM> so that it can enter into an area between the vertebral bodies; the distal end of the shape memory alloy tube <NUM> has a curved portion <NUM>. As shown in <FIG>, when the shape memory alloy tube <NUM> exhibits a certain bending angle, a force is applied to the supporting wire <NUM> to make it bent, so that the distal end of the entire balloon structure <NUM> becomes bent, and the bending angle is the same as that of the shape memory alloy tube <NUM>, as shown in <FIG>.

In this embodiment, as shown in <FIG>, <FIG>, a reinforcing tube <NUM> is also sleeved on an outer surface of the balloon outer tube <NUM>, and the reinforcing tube <NUM> is bonded with the balloon outer tube <NUM> with the medical grade glue, and the reinforcing tube <NUM> and the balloon handle fitting <NUM> are integrally injection molded.

In this embodiment, as shown in <FIG>, the distal end of the balloon outer tube <NUM> is welded to the proximal end of the balloon <NUM> by sweat soldering or laser welding, and the distal end of the balloon <NUM> is sealed with the UV adhesives <NUM>.

In an embodiment of the invention, as shown in <FIG>, the distal end of the balloon outer tube <NUM> is welded to the proximal end of the balloon <NUM> by sweat soldering or laser welding, and the distal end of the balloon <NUM> is sealed with the balloon through PU rods <NUM> by sweat soldering or laser welding.

In an embodiment of the invention, as shown in <FIG>, the balloon outer tube <NUM> is directly inserted from the proximal end of the balloon <NUM> into the distal end of the balloon <NUM>, both the proximal end and the distal end of the balloon <NUM> are welded to the balloon outer tube <NUM> by sweat soldering or laser welding; an outer tube opening <NUM> is provided on the balloon outer tube <NUM> in an interior of the balloon <NUM>; the balloon outer tube <NUM> at the distal end of the balloon <NUM> is sealed with UV adhesives <NUM>.

In an embodiment of the invention, as shown in <FIG>, the balloon outer tube <NUM> is directly inserted from the proximal end of the balloon <NUM> into the distal end of the balloon <NUM>, both the proximal end and the distal end of the balloon <NUM> are welded to the balloon outer tube <NUM> by sweat soldering or laser welding; an outer tube opening <NUM> is provided on the balloon outer tube <NUM> in an interior of the balloon <NUM>; the balloon outer tube <NUM> at the distal end of the balloon <NUM> is sealed with the balloon through the PU rods <NUM> by sweat soldering or laser welding.

In an embodiment of the invention, as shown in <FIG>, the distal end of the balloon outer tube <NUM> is welded to the proximal end of the balloon <NUM> by sweat soldering or laser welding; a balloon inner tube <NUM> is provided between the balloon outer tube <NUM> and the supporting wire <NUM>, a proximal end of the balloon inner tube <NUM> is fixed to the pore channel <NUM> at a surface of the proximal end of the protrusion <NUM>, a distal end of the balloon inner tube <NUM> is fixedly connected with the distal end of the balloon <NUM>.

In an embodiment of the invention, as shown in <FIG>, the distal end of the balloon <NUM> is welded to the balloon inner tube <NUM> through a transition tube <NUM> by sweat soldering or laser welding; the balloon inner tube <NUM> is sealed with the UV adhesives <NUM>, and the distal end of the supporting wire <NUM> bears against the UV adhesives <NUM>.

In an embodiment of the invention, as shown in <FIG>, the distal end of the balloon <NUM> is welded to the balloon inner tube <NUM> through the transition tube <NUM> by sweat soldering or laser welding; after a proximal end of a plug <NUM> is welded to the distal end of the supporting wire <NUM> by laser welding, the proximal end surface of a plug <NUM> and the distal end surface of the balloon <NUM> are bonded to and sealed with the medical grade glue.

This embodiment provides a working principle of the multifunctional vertebral body former as described in Example <NUM>.

Claim 1:
A multifunctional vertebral body former, comprising:
a balloon structure (<NUM>) comprising a balloon outer tube (<NUM>), a balloon handle (<NUM>) and a balloon (<NUM>); an outer surface of a proximal end of the balloon outer tube (<NUM>) is provided with, in a sequence from inside to outside, a balloon handle fitting (<NUM>), the balloon handle (<NUM>) and a balloon delivery snap (<NUM>) ; wherein the balloon handle (<NUM>) is connected with the balloon delivery snap (<NUM>) by a snap in a rotationally fixed manner, the balloon handle fitting (<NUM>) is fixedly connected with the balloon handle (<NUM>); a distal end of the balloon outer tube (<NUM>) is fixedly connected with the balloon (<NUM>), the balloon (<NUM>) is sealed at a distal end thereof;
a conveying tube structure (<NUM>), comprising a shape memory alloy tube (<NUM>), a slider (<NUM>), and an outer tube adjusting handle (<NUM>), wherein the shape memory alloy tube (<NUM>) is sleeved on the balloon outer tube (<NUM>) and an exterior of the balloon (<NUM>), the shape memory alloy tube (<NUM>) is formed integrally with the slider (<NUM>) by injection molding ; a proximal end of the slider (<NUM>) is detachably connected with the balloon deliver snap (<NUM>) through a first clamping lug (<NUM>); the slider (<NUM>) is provided with a threaded outer surface, the outer tube adjusting handle (<NUM>) having an internal thread structure is sleeved on the outer surface of the slider (<NUM>), wherein the outer tube adjusting handle (<NUM>) is operatively rotated to drive the slider (<NUM>) to move back and forth, so that a protruding amount of a distal end of the shape memory alloy tube (<NUM>) relative to a distal end of the outer tube (<NUM>), and a protruding amount of a distal end of the balloon (<NUM>) relative to the distal end of the shape memory alloy tube (<NUM>) are adjustably controlled.