阅读说明：本技术 一种多功能椎体成形器 (Multifunctional vertebral body shaper ) 是由 喻杰 李�东 胡冬 张鹏云 吕世文 于 2019-12-30 设计创作，主要内容包括：本发明公开了一种多功能椎体成形器,包括球囊结构和输送管结构,其中输送管结构包括形状记忆合金管、滑块和外管调节手柄,形状记忆合金管套设于球囊外管和球囊的外部,形状记忆合金管的近端与滑块的远端固定连接；滑块的近端通过第一卡耳与球囊结构可拆卸连接；滑块外表面设有螺纹结构,具有内螺纹结构的外管调节手柄套设于滑块的外表面,通过旋转外管调节手柄带动滑块前后移动,从而控制形状记忆合金管远端相对于外管远端的突出量和球囊远端相对于形状记忆合金管远端的突出量。本发明提供的多功能椎体成形器结构简单、操作容易,将骨钻的扩椎、球囊导管的预扩集中在一个器械上,简化了手术操作,缩短了手术时间,提高了手术效率,同时降低了医生体力要求和患者经济负担。(The invention discloses a multifunctional vertebral body shaper, which comprises a balloon structure and a conveying pipe structure, wherein the conveying pipe structure comprises a shape memory alloy pipe, a sliding block and an outer pipe adjusting handle, the shape memory alloy pipe is sleeved outside the balloon outer pipe and the balloon, and the near end of the shape memory alloy pipe is fixedly connected with the far end of the sliding block; the near end of the sliding block is detachably connected with the balloon structure through a first clamping lug; the outer surface of the sliding block is provided with a thread structure, the outer tube adjusting handle with an internal thread structure is sleeved on the outer surface of the sliding block, and the sliding block is driven to move back and forth by rotating the outer tube adjusting handle, so that the protruding amount of the far end of the shape memory alloy tube relative to the far end of the outer tube and the protruding amount of the far end of the saccule relative to the far end of the shape memory alloy tube are controlled. The multifunctional vertebral body shaper provided by the invention has the advantages of simple structure and easiness in operation, integrates the vertebral expansion of a bone drill and the pre-expansion of a balloon catheter on one instrument, simplifies the operation, shortens the operation time, improves the operation efficiency, and simultaneously reduces the physical requirement of a doctor and the economic burden of a patient.)

1. A multifunctional vertebral body shaper is characterized by comprising

A balloon structure (1) comprising a balloon outer tube (16), a balloon handle (11) and a balloon (15); the outer surface of the near end of the balloon outer tube (16) is sleeved with a balloon handle accessory (12), a balloon handle (11) and a balloon conveying buckle (13) from inside to outside in sequence; wherein the balloon handle (11) is fixedly connected with the balloon delivery buckle (13) in a rotatable manner through a buckle, and the balloon handle fitting (12) is fixedly connected with the balloon handle (11); the far end of the balloon outer tube (16) is fixedly connected with the balloon (15), and the far end of the balloon (15) is sealed;

the conveying pipe structure (2) comprises a shape memory alloy pipe (21), a sliding block (23) and an outer pipe adjusting handle (22), the shape memory alloy pipe (21) is sleeved outside the balloon outer pipe (16) and the balloon (15), and the shape memory alloy pipe (21) and the sliding block (23) are integrally formed in an injection molding mode; the proximal end of the sliding block (23) is detachably connected with the balloon delivery buckle (13) through a first clamping lug (231); the outer surface of the sliding block (23) is provided with a thread structure, the outer tube adjusting handle (22) with an internal thread structure is sleeved on the outer surface of the sliding block (23), and the sliding block (23) is driven to move back and forth by rotating the outer tube adjusting handle (22), so that the protruding amount of the far end of the shape memory alloy tube (21) relative to the far end of the outer tube (28) and the protruding amount of the far end of the balloon (15) relative to the far end of the shape memory alloy tube (21) are controlled.

2. The multifunctional vertebral body shaper according to claim 1, wherein the balloon structure (1) further comprises a balloon delivery snap fitting (14) sleeved outside the balloon delivery snap fitting (13), the second snap lug (131) at the distal end of the balloon delivery snap fitting (13) is inserted into a slide groove (141) on the inner surface of the balloon delivery snap fitting (14), and a snap groove (142) is arranged at the distal end of the slide groove (141); the far end of the balloon conveying buckle fitting (14) is detachably connected with a limiting piece (24) sleeved outside the sliding block (23) through a buckle; the inner circle edge of the far end of the limiting piece (24) extends towards the far end direction along the outer surface of the sliding block (23) to form a plurality of arc-shaped parts (242) which are not connected with each other, the far end of each arc-shaped part (242) is fixed at the near end of an end cover (25) through a cylindrical pin (251), and the end cover (25) is matched and locked with the working sleeve handle (31) through a locking ring (26); the outer tube adjusting handle (22) is sleeved outside the arc-shaped portion (242), and a thread structure on the outer surface of the sliding block (23) extends out of a gap of the arc-shaped portion (242) and is matched with an internal thread structure of the outer tube adjusting handle (22).

3. The multi-functional vertebral body shaper according to claim 2, wherein the outer tube (28) is sleeved outside the shape memory alloy tube (21), the outer tube (28) being integrally injection molded with the end cap (25); a top block (261) is sleeved between the distal end of the end cover (25) and the locking ring (26) and is in threaded connection with the distal end of the end cover 25; the proximal end of the locking ring (26) is fixed by the end cap (25) and the top block (261), the proximal end of the locking ring (26) can rotate around the end cap (25), and the distal end of the locking ring (26) is fixed by matching with the working sleeve handle (31) through a snap.

4. The multifunctional vertebral body shaper according to claim 1, wherein a protrusion (111) extends from the proximal end of the balloon handle (11) relative to the proximal end of the balloon handle assembly (12) and the proximal end of the balloon delivery buckle (13), the proximal end surface of the protrusion (111) is sealed to form a cavity, and a cavity interface (112) is provided on the sidewall of the protrusion (111); the balloon outer tube (16) is communicated with the outside through the protruding part (111).

5. Multifunctional vertebral body shaper according to claim 4, characterized in that a support wire seat (113) is screwed onto the outside of the proximal end surface of the protrusion (111), the support wire seat (113) being fixedly connected to the proximal end of the support wire (18), the support wire (18) being inserted in sequence into the tunnel (114) on the proximal end surface of the protrusion (111), the balloon outer tube (16) and the balloon (15), and finally the distal end surface of the support wire (18) being in contact with the distal end of the balloon (15).

6. Multifunctional vertebral body shaper according to claim 5, characterized in that a balloon inner tube (17) is or is not provided between the balloon outer tube (16) and the support wire (18), that the proximal end of the balloon inner tube (17) is fixed in the tunnel (114) on the proximal end face of the protrusion (111), and that the distal end of the balloon inner tube (17) is fixedly connected to the distal end of the balloon (15).

7. Multifunctional vertebral body shaper according to claim 6, characterized in that the balloon inner tube (17) is absent, the balloon outer tube (16) is inserted directly from the balloon (15) proximal end to the balloon (15) distal end, both the balloon (15) proximal and distal ends are heat welded or laser welded with the balloon outer tube (16); an outer tube opening (161) is arranged on the balloon outer tube (16) positioned in the balloon (15); sealed by UV glue (153) or PU rod (154) within the balloon outer tube (16) distal to the balloon (15).

8. Multifunctional vertebral body shaper according to claim 6, characterized in that the balloon inner tube (17) is provided, the balloon (15) distal end is thermally or laser welded with the balloon inner tube (17) by means of a transition tube (152); after the near end of the plug (151) is welded with the far end of the support wire (18) in a laser mode, the near end face of the plug (151) and the far end face of the balloon (15) are bonded and sealed through medical glue.

9. The multifunctional vertebral body shaper according to claim 1, wherein a reinforcing tube (121) is further sleeved on the outer surface of the balloon outer tube (16), the reinforcing tube (121) is bonded with the balloon outer tube (16) through medical grade glue, and the reinforcing tube (121) and the balloon handle fitting (12) are integrally injection-molded.

10. Multifunctional vertebral body shaper according to claim 1, characterized in that the distal end of the shape memory alloy tube (21) is provided with a length of a bend (27).

Technical Field

The invention relates to the field of medical instruments, in particular to a multifunctional vertebral body shaper.

Background

In the existing PKP vertebral body kyphoplasty, an expandable balloon is placed into a collapsed vertebral body by percutaneous puncture, an end plate is lifted by expansion of the balloon, the height of the vertebral body is recovered, kyphotic deformity is corrected, a cavity with bone shells around is formed in the vertebral body, and high-viscosity bone cement is poured under lower pressure. In order to ensure that the saccule smoothly enters the vertebral body, a working channel is established by using a puncture needle and a working sleeve, then a working cavity channel of the saccule before expansion is drilled by using a bone drill, then the saccule is sent into the vertebral body, a cavity with bone shells around is formed in the vertebral body, then the saccule is withdrawn, and finally bone cement is injected. The operation steps are complicated, and meanwhile, due to the structure of the vertebral body, in order to keep the stress balance on the biomechanics of the vertebral body, balloon expansion on two sides and bone cement injection are needed to be carried out on each section of the vertebral body. The operation needs to be performed under the X-ray monitoring, the more tedious the operation process, the longer the time, the greater the health damage to the doctor, and the higher the requirements on physical strength and operation level; the bilateral balloon dilatation and the injection of bone cement have large trauma to the patient, high chance of complications and increase the economic burden of the patient, and the above disadvantages become more prominent in the case of the lesion of the multiple vertebral bodies.

Patent CN109431589A discloses an integrated multifunctional vertebroplasty device, which includes a balloon assembly, a corner angle adjusting assembly and a corner angle open cavity assembly, but does not disclose in detail the connection relationship and working manner of the components at the proximal end to realize multiple functions.

Patent CN109745114A discloses a multi-functional vertebroplasty device, including sacculus subassembly and division chamber subassembly, the outer tube subassembly in the division chamber subassembly includes outer tube and outer tube handle, and the outer tube axial has the rigidity that bears the thrust of organizing opening the chamber and do not warp, and the outer tube handle is provided with bone filler and pours into the cavity interface. The connection and operation of the various components of the proximal end are not disclosed in detail to achieve versatility.

Therefore, it is an urgent need to provide a vertebral body shaper with simple structure and easy operation to realize the versatility of the vertebral body shaper.

Disclosure of Invention

The invention aims to solve the defects in the prior art, provides the vertebral body shaper with simple structure and easy operation, and integrates the vertebral expansion of the bone drill and the pre-expansion of the balloon catheter on one instrument, thereby simplifying the operation, shortening the operation time, improving the operation efficiency, being beneficial to reducing the damage to the health of a doctor due to the operation under the monitoring of X-ray, and simultaneously reducing the requirements of the doctor on physical strength and operation.

In order to achieve the purpose, the invention adopts the following technical scheme:

a multifunctional vertebral body shaper comprises

The balloon structure comprises a balloon outer tube, a balloon handle and a balloon; the outer surface of the near end of the balloon outer tube is sequentially sleeved with a balloon handle accessory, a balloon handle and a balloon conveying buckle from inside to outside and fixedly connected with each other; the balloon handle and the balloon conveying buckle are rotatably fixed through the buckle; the balloon outer tube is fixedly connected with the balloon far end, and the balloon far end is sealed;

the conveying pipe structure comprises a shape memory alloy pipe, a sliding block and an outer pipe adjusting handle, wherein the shape memory alloy pipe is sleeved outside the balloon outer pipe and the balloon, and the shape memory alloy pipe and the sliding block are integrally formed in an injection molding mode; the near end of the sliding block is detachably connected with the balloon conveying buckle through a first clamping lug; the outer surface of the sliding block is provided with a thread structure, the outer tube adjusting handle with an internal thread structure is sleeved on the outer surface of the sliding block, and the sliding block is driven to move back and forth by rotating the outer tube adjusting handle, so that the protruding amount of the far end of the shape memory alloy tube relative to the far end of the outer tube and the protruding amount of the far end of the saccule relative to the far end of the shape memory alloy tube are controlled.

Preferably, the balloon structure further comprises a balloon conveying buckle fitting, the balloon conveying buckle fitting is sleeved outside the balloon conveying buckle, a second clamping lug at the far end of the balloon conveying buckle is inserted into a sliding groove in the inner surface of the balloon conveying buckle fitting, and a clamping groove is formed at the far end of the sliding groove; the far end of the balloon conveying buckle accessory is detachably connected with a limiting part sleeved outside the sliding block through a buckle; the inner circle edge of the far end of the limiting piece extends towards the far end direction along the outer surface of the sliding block to form a plurality of arc-shaped parts which are not connected with each other, the far ends of the arc-shaped parts are fixed at the near end of an end cover through cylindrical pins, and the end cover is matched and locked with a working sleeve handle through a locking ring; the outer tube adjusting handle is sleeved outside the arc-shaped portion, and the thread structure on the outer surface of the sliding block extends out of the gap of the arc-shaped portion and is matched with the internal thread structure of the outer tube adjusting handle.

Furthermore, the locking ring is sleeved outside the far end of the end cover, and a top block is sleeved between the far end of the end cover and the locking ring and is in threaded connection with the far end of the end cover; the near end of the locking ring is fixed with the top block through an end cover, the near end of the locking ring can rotate around the end cover, and the far end of the locking ring is matched and fixed with the working sleeve handle through a buckle.

Preferably, the outer pipe is sleeved outside the shape memory alloy pipe, and the outer pipe and the end cover are integrally formed in an injection molding mode.

The outer tube has certain rigidity, the distal end of the vertebral body shaper is assisted to enter an intervertebral designated position, and when the distal end of the released shape memory alloy tube presents a certain bending angle and needs to be recovered to the working sleeve, the distal end of the released shape memory alloy tube can be recovered to the outer tube firstly.

Preferably, a protruding part extends out of the proximal end of the balloon handle relative to the proximal end of the balloon handle fitting and the proximal end of the balloon delivery buckle, the proximal end surface of the protruding part is sealed to form a cavity, and a cavity interface is arranged on the side wall of the protruding part; the balloon outer tube is communicated with the outside through the protruding part.

Furthermore, a support wire seat is connected to the outer side of the near end face of the protruding portion through threads, the support wire seat is fixedly connected with the near end of the support wire, the support wire is sequentially inserted into the pore channel on the near end face of the protruding portion, the balloon outer tube and the balloon, and the far end of the support wire is in contact with the far end of the balloon.

The support wire is made of plastic materials, and when the shape memory alloy tube presents a certain bending angle, a force for bending the support wire is applied to the support wire, so that the far end of the whole balloon structure is bent, and the bending angle is the same as that of the shape memory alloy tube.

Preferably, the contact part of the balloon inner tube and the balloon handle is bonded by medical glue; the contact part of the balloon handle fitting and the balloon handle is bonded by medical-grade glue.

Preferably, a balloon inner tube is or is not arranged between the balloon outer tube and the support wire, the proximal end of the balloon inner tube is fixed in the pore channel on the proximal end face of the protruding part, and the distal end of the balloon inner tube is in contact with the distal end of the balloon.

Further, the balloon inner tube is not arranged, the balloon outer tube is directly inserted from the balloon proximal end to the balloon distal end, and the balloon proximal end and the balloon distal end are both in hot-melt welding or laser welding with the balloon outer tube; an opening is arranged on the balloon outer tube in the balloon; the balloon outer tube at the distal end of the balloon is sealed by UV glue or a PU rod.

Further, in an embodiment where a balloon inner tube is provided, the distal end of the balloon inner tube and the distal end of the balloon are welded by thermal fusion or laser, and sealed by UV glue in the balloon inner tube, and the support wire is in contact with the UV glue.

Further, in one embodiment with a balloon inner tube, the balloon distal end and the balloon inner tube are hot melt welded or laser welded by a transition tube; and after the near end of the plug is welded with the far end of the support wire in a laser mode, the near end face of the plug and the far end face of the balloon are bonded and sealed through medical-grade glue.

Preferably, the outer surface of the balloon outer tube is further sleeved with a reinforcing tube, the reinforcing tube is bonded with the balloon outer tube through medical-grade glue, and the reinforcing tube and the balloon handle fitting are integrally formed in an injection molding mode.

The sacculus outer tube is that the tubular product of PU material is softer relatively, and the effect of reinforced pipe has two: one is to protect the outer balloon tube and the second is to make it easier to deliver the balloon by using the rigidity of the stiffening tube.

Preferably, the distal end of the shape memory alloy tube is provided with a section of bending part; in the initial state, the balloon is positioned in the shape memory alloy tube, the distal end of the shape memory alloy tube can be sealed in a certain way, so that cancellous bone in the vertebral body is prevented from entering the shape memory alloy tube in the process of vertebral expansion, and the vertebral expansion is realized by extruding the cancellous bone in the vertebral body by using the head end of the shape memory alloy tube to establish a balloon channel.

By adopting the technical scheme, compared with the prior art, the invention has the following technical effects:

1. the multifunctional vertebral body shaper organically combines the functions of expanding the vertebral body of the bone drill, pre-expanding the balloon catheter and filling bone cement, reduces the number of surgical instruments, simplifies surgical steps, saves surgical time and reduces the economic burden of patients;

2. the shape memory alloy tube adopts a thread structure conveying mode, so that the adjusting precision is high, and the operation is safer;

3. the shape memory alloy tube can directly reach the opposite side of the vertebral body from one side of the vertebral body puncture through the bending angle, thereby reducing the operation steps and the pressure on the body of a patient, leading the vertebral body to complete the vertebral expansion (establishing a balloon channel), the balloon pre-expansion (establishing a cavity filled with bone cement) and the injection operation of the bone cement directly connected with a bone cement injection suite only by one-time puncture, and having simple and convenient operation.

Drawings

FIG. 1 is a schematic structural diagram of a multifunctional vertebral body shaper according to the present invention;

FIG. 2a is a first angled cross-sectional view of a multi-functional vertebral body shaper of the present invention;

FIG. 2b is a schematic structural view of the region A in FIG. 2 a;

FIG. 3a is a second angle sectional view of the multi-functional vertebral body shaper of the present invention;

FIG. 3B is a schematic structural diagram of the region B in FIG. 3 a;

FIG. 4 is a cross-sectional view showing the relative positions of the proximal components of a multi-functional vertebral body shaper in accordance with the present invention;

FIG. 5 is a schematic view of the connection between a balloon delivery buckle and a slider of the multifunctional vertebral body shaper according to the present invention;

FIG. 6 is a schematic view of a slider structure of a multifunctional vertebral body shaper according to the present invention;

FIG. 7 is a schematic structural view of the multifunctional vertebral body shaper inserted into a working cannula according to the present invention;

FIG. 8a is a schematic view of the position of a buckle before the multifunctional vertebral body shaper realizes balloon pre-expansion according to the present invention;

FIG. 8b is a schematic view of a fastening position after a balloon pre-expansion is implemented by the multifunctional vertebral body shaper of the present invention;

FIG. 9 is a schematic view of a multi-functional vertebral body shaper balloon delivery snap fitting of the present invention;

FIG. 10a is a schematic view of the operation of creating a balloon channel in embodiment 2 of a multifunctional vertebral body shaper according to the present invention;

FIG. 10b is a schematic view of a second mode of operation of the multifunctional vertebral body shaper of embodiment 3 for establishing a balloon passageway according to the present invention;

FIG. 11a is a schematic view of a multi-functional vertebral body shaper according to embodiment 2 of the present invention, in which a pre-balloon dilation operation is performed;

FIG. 11b is a schematic view of a multi-functional vertebral body shaper of embodiment 3 of the present invention for implementing a balloon pre-dilation operation;

FIG. 12a is a schematic view of the working of the balloon extraction structure in embodiment 2 of the multifunctional vertebral body shaper of the present invention;

FIG. 12b is a schematic view of the operation of the balloon-pulling-out structure in embodiment 3 of the multifunctional vertebral body shaper according to the present invention;

FIG. 13a is a cross-sectional view of the balloon delivering buckle and the limiting member at a relative position before the balloon structure is pulled out by the multifunctional vertebral body shaper in accordance with the present invention;

fig. 13b is a cross-sectional view of the relative position between the balloon delivering buckle and the limiting member after the balloon structure is pulled out by the multifunctional vertebral body shaper in accordance with the present invention;

FIG. 14 is a schematic view of a balloon structure of a multifunctional vertebral body shaper according to the present invention;

FIG. 15 is a schematic structural view of the multifunctional vertebral body shaper after the balloon structure is pulled out;

FIG. 16a is a schematic view of a treatment modality for the distal end of the first balloon of the multi-functional vertebroplasty device of the present invention;

FIG. 16b is a schematic representation of a treatment modality for the distal end of the second balloon of the multi-functional vertebroplasty device of the present invention;

FIG. 16c is a schematic view of a third balloon distal end treatment version of a multi-functional vertebroplasty device of the invention;

FIG. 16d is a schematic view of a fourth balloon distal end treatment version of a multi-functional vertebroplasty device of the present invention;

FIG. 16e is a schematic representation of a treatment modality for the distal end of the fifth balloon of the multi-functional vertebroplasty device of the present invention;

FIG. 16f is a schematic view of a treatment modality for the distal end of a sixth balloon of the multi-functional vertebroplasty device of the present invention;

FIG. 17 is a schematic structural view of an end cap of a multi-functional vertebroplasty device of the present invention;

the symbols in the drawings indicate the description:

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

2-delivery tube structure, 21-shape memory alloy tube, 22-outer tube adjusting handle, 23-sliding block, 231-first clamping lug, 24-limiting piece, 241-limiting clamping groove, 242-arc part, 25-end cover, 251-cylindrical pin, 26-locking ring, 261-top block, 27-bending part, 28-outer tube,

3-working cannula structure, 31-working cannula handle, 32-working cannula;

Detailed Description

The present invention will be described in detail and specifically with reference to the following examples to facilitate better understanding of the present invention, but the following examples do not limit the scope of the present invention.

In the embodiments described below, proximal refers to the direction toward the operator, and distal refers to the direction toward the patient; clockwise is a clockwise direction relative to the operator and counterclockwise is a counterclockwise direction relative to the operator.