(19)
(11)EP 4 085 856 A1

(12)EUROPEAN PATENT APPLICATION
published in accordance with Art. 153(4) EPC

(43)Date of publication:
09.11.2022 Bulletin 2022/45

(21)Application number: 20909843.3

(22)Date of filing:  09.11.2020
(51)International Patent Classification (IPC): 
A61B 17/70(2006.01)
(86)International application number:
PCT/CN2020/127601
(87)International publication number:
WO 2021/135649 (08.07.2021 Gazette  2021/27)
(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated Extension States:
BA ME
Designated Validation States:
KH MA MD TN

(30)Priority: 30.12.2019 CN 201911402650

(71)Applicant: Ningbo Hicren Biotechnology Co., Ltd.
Ningbo, Zhejiang 315336 (CN)

(72)Inventors:
  • YU, Jie
    Hangzhou Bay New District Ningbo, Zhejiang 315336 (CN)
  • LI, Dong
    Hangzhou Bay New District Ningbo, Zhejiang 315336 (CN)
  • HU, Dong
    Hangzhou Bay New District Ningbo, Zhejiang 315336 (CN)
  • ZHANG, Pengyun
    Hangzhou Bay New District Ningbo, Zhejiang 315336 (CN)
  • LV, Shiwen
    Hangzhou Bay New District Ningbo, Zhejiang 315336 (CN)

(74)Representative: Lindner Blaumeier Patent- und Rechtsanwälte 
Partnerschaftsgesellschaft mbB Dr. Kurt-Schumacher-Str. 23
90402 Nürnberg
90402 Nürnberg (DE)

  


(54)MULTIFUNCTIONAL VERTEBRAL BODY FORMER


(57) The invention discloses a multifunctional vertebral body former, comprising a balloon structure and a conveying tube structure. The conveying tube structure comprises a shape memory alloy tube, a slider and an outer tube adjusting handle, the shape memory alloy tube is sleeved on the balloon outer tube and an exterior of the balloon, a proximal end of the shape memory alloy tube is fixedly connected with a distal end of the slider; a proximal end of the slider is detachably connected with the balloon structure through a first clamping lug; the slider is provided with a threaded outer surface, the outer tube adjusting handle having an internal thread structure is sleeved on the outer surface of the slider, the outer tube adjusting handle is rotated to drive the slider to move back and forth , so that the protruding amount of a distal end of the shape memory alloy tube relative to a distal end of the outer tube, and the protruding amount of a distal end of the balloon relative to the distal end of the shape memory alloy tube can be controlled. The multifunctional vertebral body former provided in the invention is simple in structure and easy to operate. Expansion of a bone drill and pre-expansion of a balloon catheter are integrated on one instrument. In this way, the operation is simplified, operation time is reduced, operation efficiency is improved, and requirements for physical strength of a doctor is decreased and economic burden on a patient is also reduced.




Description

BACKGROUND OF THE INVENTION


1. Field of the Invention



[0001] The invention relates to the field of medical instruments, and more particularly, to a multifunctional vertebral body former.

2. Description of the Related Art



[0002] 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.

[0003] Chinese Patent Application No. CN109431589A 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.

[0004] Chinese Patent Application No. CN109745114A discloses 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.

[0005] 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.

SUMMARY OF THE INVENTION



[0006] 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.

[0007] For achieving the above-mentioned purposes, the invention adopts the following technical solution:

a multifunctional vertebral body former, comprising:

a balloon structure comprising a balloon outer tube, a balloon handle and a balloon; an outer surface of a proximal end of the balloon outer tube is provided with, in a sequence from inside to outside, a balloon handle fitting, the balloon handle and a balloon delivery snap from the inside out, and all of those components are fixedly connected with each other; wherein the balloon handle is connected with the balloon delivery snap by a snap in a rotationally fixed manner; the balloon outer tube is fixedly connected with a distal end of the balloon , the balloon is sealed at distal end thereof;

a conveying tube structure, comprising a shape memory alloy tube, a slider, and an outer tube adjusting handle, wherein the shape memory alloy tube is sleeved on the balloon outer tube and an exterior of the balloon, the shape memory alloy tube is formed integrally with the slider by injection molding; a proximal end of the slider is detachably connected with the balloon deliver snap through a first clamping lug; the slider is provided with a threaded outer surface, the outer tube adjusting handle having an internal thread structure is sleeved on the outer surface of the slider, the outer tube adjusting handle (22) is operatively rotated to drive the slider to move back and forth, so that a protruding amount of a distal end of the shape memory alloy tube relative to a distal end of the outer tube, and a protruding amount of a distal end of the balloon relative to the distal end of the shape memory alloy tube are adjustably controlled.



[0008] 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.

[0009] 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.

[0010] 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.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] 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.

[0016] 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.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] The balloon outer tube is made of a PU material, so it is relatively softer. The reinforcing tube functions as: (1) protecting the balloon outer tube; and (2) making it easier to feed the balloon due to the rigidity of the reinforcing tube.

[0022] 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.

[0023] By adopting the above-mentioned technical solutions, the present invention has the beneficial effects over the prior art:
  1. 1. the multifunctional vertebral body former provided in the present application combines functions of expansion of a bone drill and pre-expansion of a balloon catheter, and filling of bone cement, so that the number of surgical instruments is reduced, surgical procedures are simplified, operation time is saved, and economic burden on a patient is also reduced;
  2. 2. the shape memory alloy tube is delivered by using a threaded structure, ensuring a higher adjustment precision and a safer operation;
  3. 3. the shape memory alloy tube can directly reach the opposite side of the vertebral body from a side of the vertebral body which has been punctured at a bending angle, allowing to reduce the operation procedures and to reduce stress on the patient's body; in this way, only one puncture is required to finish the following procedures: the vertebral expansion (i.e., forming the balloon passage), balloon pre-expansion (i.e., creating a cavity filled with the bone cement), and injection of the bone cement is completed by directly connecting to a bone cement injection kit, and all of those procedures are convenient to operate.

BRIEF DESCRIPTION OF THE DRAWINGS



[0024] 

Figure 1 is a schematic diagram showing a structure of a multifunctional vertebral body former according to the present invention;

Figure 2a is a cross-sectional view of a multifunctional vertebral body former at a first angle according to the present invention;

Figure 2b is a schematic diagram showing a structure of region A in Figure 2a;

Figure 3a is a cross-sectional view of a multifunctional vertebral body former at a second angle according to the present invention;

Figure 3b is a schematic diagram showing a structure of region B in Figure 2a;

Figure 4 is a cross-sectional view of the relative positional relationship of components at a proximal end of a multifunctional vertebral body former according to the present invention;

Figure 5 is a schematic diagram showing a connection status between a balloon delivery snap and a slider of a multifunctional vertebral body former according to the present invention;

Figure 6 is a schematic diagram showing a structure of the slider of a multifunctional vertebral body former according to the present invention;

Figure 7 is a schematic diagram showing a structure of a multifunctional vertebral body former after being inserted into a sleeve according to the present invention;

Figure 8a is a schematic diagram showing a position of the snap before a balloon of a multifunctional vertebral body former is pre-expanded according to the present invention;

Figure 8b is a schematic diagram showing a position of the snap after a balloon of a multifunctional vertebral body former is pre-expanded according to the present invention;

Figure 9 is a schematic diagram of a balloon delivery nap fitting of a multifunctional vertebral body former according to the present invention;

Figure 10a is a schematic diagram of a method for creating a balloon passage in example 2 of a multifunctional vertebral body former according to the present invention;

Figure 10b is a schematic diagram of a second method for creating a balloon passage in example 3 of a multifunctional vertebral body former according to the present invention;

Figure 11a is a schematic diagram of a working mode of balloon pre-expansion in example 2 of a multifunctional vertebral body former according to the present invention;

Figure 11b is a schematic diagram of a working mode of balloon pre-expansion in example 3 of a multifunctional vertebral body former according to the present invention;

Figure 12a is a schematic diagram of a working mode of pulling out a balloon structure from example 2 of a multifunctional vertebral body former according to the present invention;

Figure 12b is a schematic diagram of a working mode of pulling out a balloon structure from example 3 of a multifunctional vertebral body former according to the present invention;

Figure 13a is a cross-sectional diagram of the relative position between a balloon delivery snap and a limiting member before the balloon structure is pulled out by a multifunctional vertebral body former according to the present invention;

Figure 13b is a cross-sectional diagram of the relative position between a balloon delivery snap and a limiting member after the balloon structure is pulled out from a multifunctional vertebral body former according to the present invention;

Figure 14 is a schematic diagram of a balloon structure of a multifunctional vertebral body former according to the present invention;

Figure 15 is a schematic diagram showing a structure of a multifunctional vertebral body former from which a balloon structure is pulled out according to the present invention;

Figure 16a is a schematic diagram showing a processing mode of a distal end of a first balloon of a multifunctional vertebral body former according to the present invention;

Figure 16b is a schematic diagram showing a processing mode of a distal end of a second balloon of a multifunctional vertebral body former according to the present invention;

Figure 16c is a schematic diagram showing a processing mode of a distal end of a third balloon of a multifunctional vertebral body former according to the present invention;

Figure 16d is a schematic diagram showing a processing mode of a distal end of a fourth balloon of a multifunctional vertebral body former according to the present invention;

Figure 16e is a schematic diagram showing a processing mode of a distal end of a fifth balloon of a multifunctional vertebral body former according to the present invention;

Figure 16f is a schematic diagram showing a processing mode of a distal end of a six balloon of a multifunctional vertebral body former according to the present invention; and

Figure 17 is a schematic diagram showing a structure of an end cap of a multifunctional vertebral body former according to the present invention.


Reference numerals in the accompanying drawings:



[0025] 

1-balloon structure, 11-balloon handle, 111-protrusion, 112- cavity interface, 113-supporting wire seat, 114-pore channel, 12-balloon handle fitting, 121-reinforcing tube, 13-balloon delivery snap, 131-second clamping lug; 132-fourth clamping lug, 14-balloon delivery snap fitting, 141-chute, 142-slot, 143-third clamping lug, 15-balloon, 151-plug, 152-transition tube, 153- UV adhesive, 154- PU rod, 16- balloon outer tube, 161-outer tube opening, 17-balloon inner tube, 18-supporting wire,

2-conveying tube structure, 21-shape memory alloy tube, 22-outer tube adjusting handle, 23-slider, 231- first clamping lug, 24-limiting member, 241-limiting slot, 242-arc-shaped portion, 25-end cap, 251-cylinderical pin, 26-locking ring, 261-top block, 27-curved portion, 28-outer tube,

3-sleeve structure, 31-sleeve handle, 32-sleeve.


DETAILED DESCRIPTION



[0026] 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.

[0027] 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.

Example 1



[0028] The embodiment of the invention provides a multifunctional vertebral body former, as shown in Figures1, 2a-2b and 3a-3b, comprising:

a balloon structure 1 comprising a balloon outer tube 16, a balloon handle 11 and a balloon 15; an outer surface of a proximal end of the balloon outer tube 16 is provided with, in a sequence from inside to outside, a balloon handle fitting 12, the balloon handle 11 and a balloon delivery snap 13; wherein the balloon handle 11 is connected with the balloon delivery snap 13 by a fourth clamping lug 132 on the balloon delivery snap 13 and a slot on the balloon handle 11 in a rotationally fixed manner; the balloon handle fitting 12 is fixedly connected with the balloon handle 11; a distal end of the balloon outer tube 16 is fixedly connected with the balloon 15, and the balloon 15 is sealed at a distal end thereof;

a conveying tube structure 2, comprising a shape memory alloy tube 21, a slider 23, and an outer tube adjusting handle 22, wherein the shape memory alloy tube 21 is sleeved on the balloon outer tube 16 and an exterior of the balloon 15, the shape memory alloy tube 21 is formed integrally with the slider 23 by injection molding; a proximal end of the slider 23 is detachably connected with the balloon deliver snap 13 through a first clamping lug 231; the slider 23 is provided with a threaded outer surface, the outer tube adjusting handle 22 having an internal thread structure is sleeved on the outer surface of the slider 23, the outer tube adjusting handle 22 is operatively rotated to drive the slider 23 to move back and forth, so that a protruding amount of a distal end of the shape memory alloy tube 21 relative to a distal end of the outer tube 28, and a protruding amount of a distal end of the balloon 15 relative to the distal end of the shape memory alloy tube 21 are adjustably controlled.



[0029] In this embodiment, as shown in Figures 2a-2b, 3a-3b, the balloon structure 1 further comprises a balloon deliver snap fitting 14 sleeved outside of the balloon delivery snap 13, a second clamping lug 131 at a distal end of the balloon delivery snap 13 is inserted into a sliding chute 141 of an inner surface of the balloon deliver snap fitting 14, a distal end of the sliding chute 141 is provided with a slot 142; a distal end of the balloon deliver snap fitting 14 is detachably connected with a limiting member 24 sleeved outside of the slider 23 by a snap; an inner rounded edge at a distal end of the limiting member 24 extends a plurality of arc-shaped portions 242 which are not connected with each other along an outer surface of the slider 23 in a direction towards the distal end, a distal end of each of the plurality of arc-shaped portions 242 are fixed to a proximal end of an end cap 25 by a cylindrical pin 252, the end cap 25 is match with and locked to a sleeve handle 31 by a locking ring 26; the outer tube adjusting handle 22 is sleeved outside of the arc-shaped portions 242, the threaded structure on the outer surface of the slider 23 extends beyond a gap of the arc-shaped portions 242, and matches with the internal threaded structure of the outer tube adjusting handle 22.

[0030] In this embodiment, the locking ring 26 is sleeved on an area external to a distal end of the end cap 25, a top block 261 is sleeved between the distal end of the end cap 25 and the locking ring 26, and is in threaded connection with the distal end of the end cap 25; a proximal end of the locking ring 26 is fixed to the top block 261 through the end cap 25, the proximal end of the locking ring 26 can rotate about the end cap 25, and a distal end of the locking ring 26 is fixed with the sleeve handle 31 by the snap.

[0031] In this embodiment, as shown in Figures 1, 17, the outer tube 28 is sleeved on the exterior of the shape memory alloy tube 21, the outer tube 28 is formed integrally with the end cap 25 by injection molding. Since the outer tube 28 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 21 has a certain bending angle, it can be withdrawn into the outer tube 28 before being withdrawn into the sleeve 32.

[0032] In this embodiment, as shown in Figure 4, a proximal end of the balloon handle 11 extends a protrusion 111 relative to a proximal end of the balloon handle fitting 12 and a proximal end of the balloon delivery snap 13, a proximal end surface of the protrusion 111 is closed to form a cavity, a side wall of the protrusion 111 is provided with a cavity interface 112; the balloon outer tube 16 is in communication with the outside through the protrusion 111.

[0033] In this embodiment, as shown in Figures 2a, 3a, 4, 16a-16f, the outside of the proximal end surface of the protrusion 111 is connected to a supporting wire seat 113 through a screw thread, the supporting wire seat 113 is fixedly connected with a proximal end of the supporting wire 18, the supporting wire 18 is inserted into a pore channel 114 at the proximal end surface of the protrusion 111, the balloon outer tube 16 and the balloon 15 in sequence, and finally, a distal end surface of the supporting wire 18 is in contact with the distal end of the balloon 15; when the distal end of the supporting wire 18 is not provided with the plug 151 welded thereto, it can be separated from the supporting seat by rotating the supporting wire seat 113, and then the whole supporting wire 18 is pulled out.

[0034] In an embodiment of the invention, in Figure 10b, a section of a curved portion 27 is provided at the distal end of the shape memory alloy tube 21; the balloon 15 is located at an interior of the shape memory alloy tube 21 in its initial state. In this way, the distal end of the shape memory alloy tube 21 is sealed, to some extent, so that cancellous bone inside the vertebral body can be prevented from entering the shape memory alloy tube 21 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 90° 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 20 °C, 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 37°C, 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.

[0035] In this embodiment, the supporting wire 18 is made of semi-rigid material, which provides sufficient rigidity to the distal end of the balloon structure 1 so that it can enter into an area between the vertebral bodies; the distal end of the shape memory alloy tube 21 has a curved portion 27. As shown in Figure 10b, when the shape memory alloy tube 21 exhibits a certain bending angle, a force is applied to the supporting wire 18 to make it bent, so that the distal end of the entire balloon structure 1 becomes bent, and the bending angle is the same as that of the shape memory alloy tube 21, as shown in Figure 11b.

[0036] In this embodiment, as shown in Figures 4, 16a-16b, a reinforcing tube 121 is also sleeved on an outer surface of the balloon outer tube 16, and the reinforcing tube 121 is bonded with the balloon outer tube 16 with the medical grade glue, and the reinforcing tube 121 and the balloon handle fitting 12 are integrally injection molded.

[0037] In this embodiment, as shown in Figure 16a, the distal end of the balloon outer tube 16 is welded to the proximal end of the balloon 15 by sweat soldering or laser welding, and the distal end of the balloon 15 is sealed with the UV adhesives 153.

[0038] In an embodiment of the invention, as shown in Figure 16b, the distal end of the balloon outer tube 16 is welded to the proximal end of the balloon 15 by sweat soldering or laser welding, and the distal end of the balloon 15 is sealed with the balloon through PU rods 154 by sweat soldering or laser welding.

[0039] In an embodiment of the invention, as shown in Figure 16c, the balloon outer tube 16 is directly inserted from the proximal end of the balloon 15 into the distal end of the balloon 15, both the proximal end and the distal end of the balloon 15 are welded to the balloon outer tube 16 by sweat soldering or laser welding; an outer tube opening 161 is provided on the balloon outer tube 16 in an interior of the balloon 15; the balloon outer tube 16 at the distal end of the balloon 15 is sealed with UV adhesives 153.

[0040] In an embodiment of the invention, as shown in Figure 16d, the balloon outer tube 16 is directly inserted from the proximal end of the balloon 15 into the distal end of the balloon 15, both the proximal end and the distal end of the balloon 15 are welded to the balloon outer tube 16 by sweat soldering or laser welding; an outer tube opening 161 is provided on the balloon outer tube 16 in an interior of the balloon 15; the balloon outer tube 16 at the distal end of the balloon 15 is sealed with the balloon through the PU rods 154 by sweat soldering or laser welding.

[0041] In an embodiment of the invention, as shown in Figures 16e-16f, the distal end of the balloon outer tube 16 is welded to the proximal end of the balloon 15 by sweat soldering or laser welding; a balloon inner tube 17 is provided between the balloon outer tube 16 and the supporting wire 18, a proximal end of the balloon inner tube 17 is fixed to the pore channel 114 at a surface of the proximal end of the protrusion 111, a distal end of the balloon inner tube 17 is fixedly connected with the distal end of the balloon 15.

[0042] In an embodiment of the invention, as shown in Figure 16e, the distal end of the balloon 15 is welded to the balloon inner tube 17 through a transition tube 152 by sweat soldering or laser welding; the balloon inner tube 17 is sealed with the UV adhesives 153, and the distal end of the supporting wire 18 bears against the UV adhesives 153.

[0043] In an embodiment of the invention, as shown in Figure 16f, the distal end of the balloon 15 is welded to the balloon inner tube 17 through the transition tube 152 by sweat soldering or laser welding; after a proximal end of a plug 151 is welded to the distal end of the supporting wire 18 by laser welding, the proximal end surface of a plug 151 and the distal end surface of the balloon 15 are bonded to and sealed with the medical grade glue.

Example 2



[0044] This embodiment provides a working principle of the multifunctional vertebral body former as described in Example 1.
  1. (1) before it works, as shown in Figures 2a, 3a, 5, 14-15, the conveying tube structure 2 is connected to an area outside of the balloon structure 1 by a snap, the first clamping lug 231 on the slider 23 is clamped on the slot at the distal end of the balloon delivery snap 13, the third clamping lug 143 on the balloon delivery snap fitting 14 is clamped on the limiting slot 241 on the limiting member 24; as shown in Figures 1 and 5, after a working channel is established, the multifunctional vertebral body former provided in Example 1 is inserted into the sleeve structure 3, rotating the locking ring 26 to make the multifunctional vertebral body former fixed to the sleeve handle 31 on the sleeve structure 3;
  2. (2) as shown in Figure 10a, rotating the outer tube adjusting handle 22 clockwise, and driving the balloon structure 1 and the slider 23 to move forward through the thread transmission of the outer tube adjusting handle 22 and the slider 23, so that the balloon 15 follows the shape memory alloy tube 21 to extend into the interior of the vertebral body until the shape memory alloy tube 21 extends to a preset position, so as to achieve vertebral expansion and establish a balloon passage; as shown in Figure 9, after the balloon passage is established, the second clamping lug 131 on the balloon delivery snap 13 is located at a bottom of the chute 141 of the balloon delivery snap fitting 14;
  3. (3) as shown in Figures 8a-8b,Figure 9, and Figure 11, rotating the balloon delivery snap 13 counterclockwise to make the first clamping lug 231 on the slider 23 completely free from the restriction of the slot at the distal end of the balloon delivery snap 13, and thus to make the slider 23 completely free from the restriction of the balloon delivery snap 13, and rotating the second clamping lug 131 into the slot 142 at a bottom of the chute 141 of the balloon delivery snap fitting 14; then rotating the outer tube adjusting handle 22 counterclockwise so that the shape memory alloy tube 21 can be withdrawn into the outer tube 28, and the balloon 15 is completely placed into the well-established balloon passage;
  4. (4) a connection to a pressure pump is established through the cavity interface 112 on the balloon handle 11, and contrast agent is injected into the balloon 15 to reset the vertebral body for compression fractures and create a cavity filled with bone cement to achieve unilateral balloon pre-expansion; after the unilateral balloon pre-expansion is completed, the contrast agent injected into the balloon 15 is withdrawn by the pressure pump;
  5. (5) the vertebral body is punctured at the other side using the same other surgical device, so as to achieve balloon pre-expansion at the other side of the vertebral body, after the balloon pre-expansion is completed, the contrast agent injected into the balloon 15 is withdrawn by the pressure pump;
  6. (6) as shown in Figures 13a-13b and 12a, rotating the balloon delivery snap fitting 14 clockwise to make the two third clamping lugs 143 on the balloon delivery snap fitting 14 free from the restriction of the limiting member 24, and then pulling out the balloon structure as shown in Figure 14;
  7. (7) after the bone cement injection kit is connected to a joint on the slider 23 in a structure as shown in Figure 15, the bone cement is injected into the established bone cement filling cavity, and finally the sleeve is withdrawn and the operation is completed.

Example 3



[0045] This embodiment provides a working principle of the multifunctional vertebral body former as described in Example 1.
  1. (1) before it works, as shown in Figures 2a, 3a, 5, 14-15, the conveying tube structure 2 is connected to an area outside of the balloon structure 1 by a snap, the first clamping lug 231 on the slider 23 is clamped on the slot at the distal end of the balloon delivery snap 13, the third clamping lug 143 on the balloon delivery snap fitting 14 is clamped on the limiting slot 241 on the limiting member 24; as shown in Figures 1 and 5, after a working channel is established, the multifunctional vertebral body former provided in Example 1 is inserted into the sleeve structure 3, rotating the locking ring 26 to make the multifunctional vertebral body former fixed to the sleeve handle 31 on the sleeve structure 3;
  2. (2) as shown in Figure 10b, rotating the outer tube adjusting handle 22 clockwise, and driving the balloon structure 1 and the slider 23 to move forward through the thread transmission of the outer tube adjusting handle 22 and the slider 23, so that the balloon 15 follows the shape memory alloy tube 21 to extend into the interior of the vertebral body until the shape memory alloy tube 21 extends to a preset position, so as to achieve vertebral expansion and establish a balloon passage, the shape memory alloy tube 21 can directly reach the opposite side of the vertebral body by puncturing at one side of the vertebral body through the curved portion 27; as shown in Figure 9, after the balloon passage is established, the second clamping lug 131 on the balloon delivery snap 13 is located at a bottom of the chute 141 of the balloon delivery snap fitting 14;
  3. (3) as shown in Figures 8a-8b, Figure 9, and Figure 11b, rotating the balloon delivery snap 13 counterclockwise to make the first clamping lug 231 on the slider 23 completely free from the restriction of the slot at the distal end of the balloon delivery snap 13, and thus to make the slider 23 completely free from the restriction of the balloon delivery snap 13, and rotating the second clamping lug 131 into the slot 142 at a bottom of the chute 141 of the balloon delivery snap fitting 14, the balloon delivery snap 13 is locked with the balloon delivery snap fitting 14; then rotating the outer tube adjusting handle 22 counterclockwise so that the shape memory alloy tube 21 can be withdrawn into the outer tube 28, and the balloon 15 is completely placed into the well-established balloon passage;
  4. (4) a connection to a pressure pump is established through the cavity interface 112 on the balloon handle 11, and contrast agent is injected into the balloon 15 to reset the vertebral body for compression fractures and create a cavity filled with bone cement to achieve unilateral balloon pre-expansion; after the unilateral balloon pre-expansion is completed, the contrast agent injected into the balloon 15 is withdrawn by the pressure pump;
  5. (5) as shown in Figures 12a and 13a-13b, rotating the balloon delivery snap fitting 14 clockwise to make the two third clamping lugs 143 on the balloon delivery snap fitting 14 free from the restriction of the limiting member 24, and then pulling out the balloon structure as shown in Figure 14;
  6. (6) after the bone cement injection kit is connected to a joint on the slider 23 in a structure as shown in Figure 15, the bone cement is injected into the established bone cement filling cavity, and finally the sleeve is withdrawn and the operation is completed.


[0046] The above descriptions are only the preferred embodiments of the invention, not thus limiting the embodiments and scope of the invention. Those skilled in the art should be able to realize that the schemes obtained from the content of specification and drawings of the invention are within the scope of the invention.


Claims

1. A multifunctional vertebral body former, comprising:

a balloon structure (1) comprising a balloon outer tube (16), a balloon handle (11) and a balloon (15); an outer surface of a proximal end of the balloon outer tube (16) is provided with, in a sequence from inside to outside, a balloon handle fitting (12), the balloon handle (11) and a balloon delivery snap (13) ; wherein the balloon handle (11) is connected with the balloon delivery snap (13) by a snap in a rotationally fixed manner, the balloon handle fitting (12) is fixedly connected with the balloon handle (11); a distal end of the balloon outer tube (16) is fixedly connected with the balloon (15), the balloon (15) is sealed at a distal end thereof;

a conveying tube structure (2), comprising a shape memory alloy tube (21), a slider (23), and an outer tube adjusting handle (22), wherein the shape memory alloy tube (21) is sleeved on the balloon outer tube (16) and an exterior of the balloon (15), the shape memory alloy tube (21) is formed integrally with the slider (13) by injection molding ; a proximal end of the slider (23) is detachably connected with the balloon deliver snap (13) through a first clamping lug (231); the slider (23) is provided with a threaded outer surface, the outer tube adjusting handle (22) having an internal thread structure is sleeved on the outer surface of the slider (23), wherein the outer tube adjusting handle (22) is operatively rotated to drive the slider (23) to move back and forth, so that a protruding amount of a distal end of the shape memory alloy tube (21) relative to a distal end of the outer tube (28), and a protruding amount of a distal end of the balloon (15) relative to the distal end of the shape memory alloy tube (21) are adjustably controlled.


 
2. The multifunctional vertebral body former of claim 1, wherein the balloon structure (1) further comprises a balloon deliver snap fitting (14) sleeved outside of the balloon delivery snap (13), a second clamping lug (131) at a distal end of the balloon delivery snap (13) is inserted into a sliding chute (141) of an inner surface of the balloon deliver snap fitting (14), a distal end of the sliding chute (141) is provided with a slot (142); a distal end of the balloon deliver snap fitting (14) is detachably connected with a limiting member (24) sleeved outside of the slider (23) by a snap; an inner rounded edge at a distal end of the limiting member (24) extends a plurality of arc-shaped portions (242) which are not connected with each other along an outer surface of the slider (23) in a direction towards the distal end, a distal end of each of the plurality of arc-shaped portions (242) are fixed to a proximal end of an end cap (25) by a cylindrical pin (251), the end cap (25) is match with and locked to a sleeve handle (31) by a locking ring (26); the outer tube adjusting handle (22) is sleeved outside of the arc-shaped portions (242), the threaded structure on the outer surface of the slider (23) extends beyond a gap of the arc-shaped portions (242), and matches with the internal threaded structure of the outer tube adjusting handle (22).
 
3. The multifunctional vertebral body former of claim 2, wherein the outer tube (28) is sleeved on the exterior of the shape memory alloy tube (21), the outer tube (28) is formed integrally with the end cap (25) by injection molding; a top block (261) is sleeved between a distal end of the end cap (25) and the locking ring (26), and is in threaded connection with the distal end of the end cap (25); a proximal end of the locking ring (26) is fixed to the top block (261) through the end cap (25), the proximal end of the locking ring (26) can rotate about the end cap (25), and a distal end of the locking ring (26) is fixed with the sleeve handle (31) by the snap.
 
4. The multifunctional vertebral body former of claim 1, wherein a proximal end of the balloon handle (11) extends a protrusion (111) relative to a proximal end of the balloon handle fitting (12) and a proximal end of the balloon delivery snap (13), a proximal end surface of the protrusion (111) is closed to form a cavity, a side wall of the protrusion (111) is provided with a cavity interface (112); the balloon outer tube (16) is in communication with the outside through the protrusion (111).
 
5. The multifunctional vertebral body former of claim 4, wherein the outside of the proximal end surface of the protrusion (111) is connected to a supporting wire seat (113) through a screw thread, the supporting wire seat (113) is fixedly connected with a proximal end of the supporting wire (18), the supporting wire (18) is inserted into a pore channel (114) at the proximal end surface of the protrusion (111), the balloon outer tube (16) and the balloon (15) in sequence, and finally, a distal end surface of the supporting wire (18) is in contact with the distal end of the balloon (15).
 
6. The multifunctional vertebral body former of claim 5, wherein a balloon inner tube (17) is further provided or not provided between the balloon outer tube (16) and the supporting wire (18), a proximal end of the balloon inner tube (17) is fixed to the pore channel (114) on the proximal end surface of the protrusion (111), a distal end of the balloon inner tube (17) is fixedly connected with the distal end of the balloon (15).
 
7. The multifunctional vertebral body former of claim 6, wherein the balloon inner tube (17) is not provided, the balloon outer tube (16) is inserted from the proximal end of the balloon (15) into the distal end of the balloon (15), both the proximal end and the distal end of the balloon (15) are welded to the balloon outer tube (16) by sweat soldering or laser welding; an outer tube opening (161) is provided on the balloon outer tube (16) in an interior of the balloon (15); the balloon outer tube (16) at the distal end of the balloon (15) is sealed with UV adhesives (153) or PU rods (154) .
 
8. The multifunctional vertebral body former of claim 6, wherein the balloon inner tube (17) is provided, the distal end of the balloon (15) is welded to the balloon inner tube (17) through a transition tube (152) by sweat soldering or laser welding; after a proximal end of a plug (151) is welded to the distal end of the supporting wire (18) by laser welding, the proximal end of a plug (151) and the distal end of the balloon (15) are bonded to and sealed with medical grade glue.
 
9. The multifunctional vertebral body former of claim 1, wherein a reinforcing tube (121) is also sleeved on an outer surface of the balloon outer tube (16), and the reinforcing tube (121) is bonded to the balloon outer tube (16) with the medical grade glue, and the reinforcing tube (121) and the balloon handle fitting (12) are integrally injection molded.
 
10. The multifunctional vertebral body former of claim 1, wherein a section of a curved portion (27) is provided at the distal end of the shape memory alloy tube (21).
 




Drawing




























Search report













Cited references

REFERENCES CITED IN THE DESCRIPTION



This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

Patent documents cited in the description