CN109157311B - A minimally invasive implantable shape memory interbody cage - Google Patents
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Abstract
本发明申请是201410358699.9的分案申请,本发明涉及一种用于脊柱外科的微创置入形状记忆椎间融合器。本微创置入形状记忆椎间融合器为框架式中空结构,由若干根立柱轴、正梁、侧梁、记忆变形侧梁、记忆变形正梁、若干个轴周环和一个开放窗口组成。正梁、侧梁、记忆变形侧梁、记忆变形正梁两端通过卡槽结构和凸头结构和轴周环互相连接,不同层面的轴周环互相对应的套在立柱轴上。其中,记忆变形侧梁和记忆变形正梁是由具有形状记忆功能的医用钛-镍记忆合金制作而成。本发明可以通过目前微小的通道进入椎间隙,不仅有创伤小、痛苦轻、恢复快、并发症少等优点,其撑开后可以增加和椎体上下终板的接触面积,更多的植入骨质,提高融合率。
The application of the present invention is a divisional application of 201410358699.9, and the present invention relates to a minimally invasive implanted shape memory interbody fusion cage for spinal surgery. The minimally invasive implanted shape memory intervertebral cage is a frame-type hollow structure, which consists of several column shafts, main beams, side beams, memory deformation side beams, memory deformation main beams, several shaft rings and an open window. The front beam, the side beam, the memory deformation side beam, and the memory deformation front beam are connected to each other through the groove structure, the convex head structure and the shaft peripheral ring, and the shaft peripheral rings of different levels are sleeved on the column shaft correspondingly. Among them, the memory deformation side beam and the memory deformation main beam are made of medical titanium-nickel memory alloy with shape memory function. The invention can enter the intervertebral space through the current tiny channel, not only has the advantages of less trauma, less pain, quick recovery, less complications, etc., but also can increase the contact area with the upper and lower endplates of the vertebral body after being stretched, and more implantation Bone, improve fusion rate.
Description
本发明专利申请是分案申请,原案的申请号是:201410358699.9,申请日是:2014年7月27日,发明名称是:一种微创置入形状记忆椎间融合器。The patent application of the present invention is a divisional application, the application number of the original case is: 201410358699.9, the application date is: July 27, 2014, and the name of the invention is: a minimally invasive implanted shape memory interbody fusion device.
技术领域technical field
本发明涉及一种用于医学领域、脊柱外科的微创置入形状记忆椎间融合器。The invention relates to a minimally invasive inserting shape memory intervertebral fusion cage used in the medical field and spine surgery.
背景技术Background technique
脊柱退行性变引起的颈椎间盘突出症、颈椎管狭窄症、颈椎节段不稳、胸椎间盘突出症、腰椎间盘突出症、腰椎管狭窄症、腰椎节段不稳、腰椎滑移等疾病在临床上十分常见。腰椎椎间融合术疗效确切,已有百年应用历史,是治疗此类疾病的主要手段,也是脊柱外科应用最为广泛的手术方式之一。Cervical disc herniation, cervical spinal stenosis, cervical segmental instability, thoracic disc herniation, lumbar disc herniation, lumbar spinal stenosis, lumbar segmental instability, lumbar spondylolisthesis and other diseases caused by spinal degeneration very common. Lumbar interbody fusion has a definite curative effect and has been used for over a hundred years.
椎间融合术包括前路椎间融合术,后路椎间融合术、经椎间孔入路腰椎椎间融合术、腰椎侧方入路椎间融合术等。Interbody fusion includes anterior interbody fusion, posterior interbody fusion, transforaminal lumbar interbody fusion, and lateral lumbar interbody fusion.
前路椎间融合术从前方进入椎间隙,能更有效地撑开和恢复椎间隙高度,同时前方入路能更彻底地清除变性的椎间盘,而且ALIF无须牵拉硬膜囊和神经根,从而避免了神经根和硬膜囊的损伤。另外,ALIF还保护了椎板、小关节等腰椎后部结构的完整。颈椎手术前路常见,但是腰椎手术前方入路易损伤大血管和交感神经丛,导致逆行性射精及小便障碍等并发症。Anterior intervertebral fusion can enter the intervertebral space from the front, which can spread and restore the height of the intervertebral space more effectively. At the same time, the anterior approach can more thoroughly remove the degenerated intervertebral disc, and ALIF does not need to pull the dural sac and nerve root, so Damage to nerve roots and dural sac is avoided. In addition, ALIF also protects the integrity of the posterior structures of the lumbar spine, such as the lamina and facet joints. The anterior approach of cervical spine surgery is common, but the anterior approach of lumbar spine surgery damages the great blood vessels and sympathetic plexus, leading to complications such as retrograde ejaculation and urinary disturbance.
后路椎间融合术是经后路椎管完成椎间融合,以获得腰椎前中柱的稳定,经椎间孔入路腰椎椎间融合术是从单侧椎间孔入路进入腰椎间隙,完成椎间盘切除、植骨、椎间融合器植入等一系列过程,也能提供腰椎双侧的前、中柱支撑,而附加后外侧植骨和坚强的内固定,也可以获得腰椎的四周融合。腰椎侧方入路椎间融合术是通过侧方分离肌肉达到腰椎侧方,进行减压融合的手术。Posterior lumbar interbody fusion is to complete intervertebral fusion through the posterior spinal canal to obtain the stability of the anterior and central lumbar spine. Transforaminal lumbar interbody fusion is to enter the lumbar intervertebral space from a unilateral foraminal approach. Complete a series of procedures such as intervertebral discectomy, bone grafting, and interbody cage implantation, and can also provide bilateral anterior and central column support for the lumbar vertebrae. With the addition of posterolateral bone grafting and strong internal fixation, peripheral fusion of the lumbar vertebrae can also be obtained. . Lateral lumbar interbody fusion is an operation that separates the muscles laterally to the side of the lumbar spine and performs decompression and fusion.
各种手术方式均为开放手术,创伤较大,并发症较多;随着医用手术器械高精技术、数码成像技术及电脑智能化技术等的迅速发展,微创外科的理念不断的被外科医师认可和接受,具有创伤小、痛苦轻、恢复快、并发症少等多种优点的微创手术方式被外科不断探索。Various surgical methods are open surgery, with larger trauma and more complications; with the rapid development of high-precision medical surgical instrument technology, digital imaging technology and computer intelligent technology, the concept of minimally invasive surgery is constantly being adopted by surgeons. Recognized and accepted, minimally invasive surgical methods with many advantages such as less trauma, less pain, faster recovery, and fewer complications are constantly explored by surgery.
如小切口结合特制的内镜拉钩或电视内镜辅助下行前路椎间融合术、侧方入路椎间融合术,后路内镜辅助下行后路脊柱椎间融合术、经椎间孔腰椎椎间融合术。Such as small incision combined with special endoscopic retractor or video endoscope-assisted anterior interbody fusion, lateral interbody fusion, posterior endoscopic-assisted posterior spinal fusion, transforaminal lumbar spine Interbody fusion.
国外Grob等利用两枚斜向螺钉对上位椎体前移大于25%同时椎间隙高度小于75%的患者行腰椎融合术(Direct pediculo-body fixation),Birkenmaier等将本技术认为非滑移患者也是本手术的指征,同时在导航下开展本手术,命名为:导航斜向腰椎椎间融合术(Guided Oblique Lumbar Interbody Fusion,GO-LIF)。Foreign Grob et al. used two oblique screws to perform lumbar fusion (Direct pediculo-body fixation) for patients with an anterior displacement of the upper vertebral body greater than 25% and a disc space height of less than 75%. Birkenmaier et al. The indication for this operation, and this operation is carried out under navigation, is named: Guided Oblique Lumbar Interbody Fusion (GO-LIF).
以上这些微创术式均具有创伤小、痛苦轻、恢复快、并发症少等多种优点。These minimally invasive procedures all have the advantages of less trauma, less pain, faster recovery, and fewer complications.
但传统的椎间融合器因为切口变小,无法适用,需要新型的小型椎间融合器,但如果椎间融合器体积过小又会导致和上下终板的接触面积变小,无法实现理想的椎间融合,导致手术失败。However, the traditional cage cannot be used due to the smaller incision, and a new type of small cage is needed. However, if the size of the cage is too small, the contact area with the upper and lower endplates will become smaller, and the ideal cage cannot be achieved. Intervertebral fusion, resulting in a failed operation.
随着椎间融合器的改进,目前已有报道可膨胀性椎间融合器(如:B-twin产品,Disc-O-tech Medical Technologies,Ltd.Israel),可以采用经皮的方式植入,植入后膨胀,达到椎间融合的目的。但是其采用机械旋转压缩方式,中间植骨面积小,仅呈花蕾状散开。With the improvement of intervertebral cages, expandable intervertebral cages (such as B-twin products, Disc-O-tech Medical Technologies, Ltd. Israel) have been reported, which can be implanted percutaneously. Expanded after implantation to achieve the purpose of intervertebral fusion. However, it adopts the mechanical rotation compression method, and the bone graft area in the middle is small, and it only spreads out in a bud shape.
目前记忆合金技术可以达到微小植入,在体内撑开的作用,之前的公开专利(公开号CN1449725A,专利号:03113393.2)描述了一种通过滚圆式技术撑开的形状记忆合金微创椎体间融合器,该技术利用了记忆合金形状记忆的功能,但是撑开后,出上下接触上下终板外,周围无阻挡栅栏,骨质容易向周围渗漏。但形状记忆合金是微创椎间融合器的一大优势材料。At present, memory alloy technology can achieve the effect of micro-implantation and expansion in the body. The previous published patent (publication number CN1449725A, patent number: 03113393.2) describes a shape memory alloy minimally invasive intervertebral body that is opened by spheronization technology Cage, this technology utilizes the shape memory function of memory alloys, but after being stretched, the upper and lower endplates come out to contact the upper and lower endplates. There is no blocking fence around, and the bone is easy to leak to the surrounding. But shape memory alloys are a major advantage of minimally invasive cages.
发明内容SUMMARY OF THE INVENTION
如何达到微创通道下置入椎间融合器,使其在体内撑开,同时可以很好的进行植骨融合。我们设计了这种微创置入形状记忆椎间融合器。How to insert an intervertebral cage under the minimally invasive channel, so that it can be stretched in the body, and at the same time, bone graft fusion can be performed well. We designed this minimally invasive implantable shape memory cage.
本发明是通过以下技术方案实现的:The present invention is achieved through the following technical solutions:
1、本微创置入形状记忆椎间融合器为框架式中空结构,由若干根立柱轴、正梁、侧梁、记忆变形侧梁、记忆变形正梁、若干个轴周环和一个开放窗口组成。1. The minimally invasive implanted shape memory interbody cage is a frame-type hollow structure, which consists of several column shafts, main beams, side beams, memory deformation side beams, memory deformation main beams, several axial rings and an open window. composition.
2、正梁、侧梁、记忆变形侧梁、记忆变形正梁两端均设有卡槽结构或凸头结构中的一种结构,轴周环的周缘360度范围也设有卡槽结构或凸头结构中的一种结构,如果正梁、侧梁、记忆变形侧梁、记忆变形正梁两端设卡槽结构,则轴周环的周缘360度范围设凸头结构;如果正梁、侧梁、记忆变形侧梁、记忆变形正梁两端设凸头结构,则轴周环的周缘360度范围设卡槽结构,即正梁、侧梁、记忆变形侧梁、记忆变形正梁两端通过卡槽结构和凸头结构和轴周环互相连接,使正梁、侧梁、记忆变形侧梁、记忆变形正梁可以绕轴周环的周缘旋转移动。2. The front beam, the side beam, the memory deformation side beam, and the memory deformation front beam are provided with a card groove structure or one of the convex head structures at both ends. One of the convex head structures, if the main beam, the side beam, the memory deformation side beam, and the memory deformation main beam are provided with a slot structure, then the 360-degree range of the periphery of the shaft peripheral ring is provided with a convex head structure; if the main beam, The side beams, the memory deformation side beams, and the memory deformation main beams are provided with convex head structures at both ends, and the 360-degree range of the periphery of the shaft ring is provided with a slot structure, that is, the main beam, the side beams, the memory deformation side beams, and the memory deformation main beams. The ends are connected to each other through the groove structure, the convex head structure and the shaft peripheral ring, so that the main beam, the side beam, the memory deformation side beam, and the memory deformation main beam can rotate and move around the periphery of the shaft peripheral ring.
3、正梁两端均连接在一个和侧梁的一端连接的轴周环上。3. Both ends of the front beam are connected to a shaft peripheral ring connected to one end of the side beam.
4、侧梁的一端连接在一个和正梁的一端连接的轴周环上,另一端连接在一个和记忆变形侧梁与记忆变形正梁连接的轴周环上。4. One end of the side beam is connected to a shaft peripheral ring connected to one end of the main beam, and the other end is connected to a shaft peripheral ring connected to the memory deformation side beam and the memory deformation main beam.
5、记忆变形侧梁和记忆变形正梁的两端分别连接在一个和和侧梁的一端连接的轴周环上。5. Both ends of the memory-deformable side beam and the memory-deformation main beam are respectively connected to a shaft peripheral ring connected to one end of the side beam.
6、不同层面的轴周环互相对应的套在立柱轴上,可以绕立柱轴旋转,组成了本发明的立体空间结构。6. The shaft peripheral rings at different levels are sleeved on the column shaft corresponding to each other, and can rotate around the column shaft to form the three-dimensional space structure of the present invention.
7、记忆变形侧梁和记忆变形正梁是由具有形状记忆功能的医用钛-镍记忆合金制作而成,其形状因为温度不同而发生变化,从而达到植入人体后,在37摄氏度左右变直,使整体变大,增加和椎体上下终板的接触面积,更多的植入骨质,提高融合率。7. The memory deformation side beam and the memory deformation main beam are made of medical titanium-nickel memory alloy with shape memory function, and their shape changes due to different temperatures, so that after implantation into the human body, it becomes straight at about 37 degrees Celsius , make the whole larger, increase the contact area with the upper and lower endplates of the vertebral body, more implanted bone, and improve the fusion rate.
8、若干根不同层面的正梁组成的面上设有开放窗口,人工骨或者自体骨可以通过开放窗口置入本发明内部。8. There are open windows on the surface composed of several main beams at different levels, and artificial bone or autologous bone can be inserted into the present invention through the open windows.
9、本发明的正梁和侧梁中的一部分正梁和侧梁是由不透X光线的材料制成,可以为手术提供位置判断作用。9. A part of the front beam and the side beams of the present invention are made of materials that are opaque to X-rays, which can provide a position judgment function for the operation.
本发明可以达到的有益效果The beneficial effects that the present invention can achieve
这种微创置入形状记忆椎间融合器未变形前体积微小,可以通过目前微小的通道进入椎间隙,当进入体内后,温度达到37摄氏度左右时,记忆变形侧梁和记忆变形正梁变直,使整体变大,从而达到目的,本发明联合目前多种多样的微创椎间融合术,可以满足其小通道植入的要求。The minimally invasive implanted shape memory interbody cage has a small volume before deformation, and can enter the intervertebral space through the current tiny channel. Straight, making the whole larger, so as to achieve the purpose, the present invention can meet the requirements of the small channel implantation in combination with the current various minimally invasive interbody fusion.
因此,本发明结合微创技术,不仅有创伤小、痛苦轻、恢复快、并发症少等优点,其撑开后可以增加和椎体上下终板的接触面积,更多的植入骨质,提高融合率。Therefore, combined with the minimally invasive technology, the present invention not only has the advantages of less trauma, less pain, faster recovery, less complications, etc., but also can increase the contact area with the upper and lower endplates of the vertebral body after being stretched, and more implanted bone, Improve fusion rate.
附图说明Description of drawings
附图:图1:本发明未变形前的结构示意图。Accompanying drawing: Fig. 1: The structural schematic diagram of the present invention before deformation.
图2:本发明变形后的结构示意图。Figure 2: Schematic diagram of the deformed structure of the present invention.
图3:本发明未变形前俯视图。Figure 3: A top plan view of the present invention before deformation.
图4:本发明变形后俯视图。Figure 4: Top view of the present invention after deformation.
图5:本发明卡槽结构和凸头结构的截面示意图。FIG. 5 is a schematic cross-sectional view of the slot structure and the protruding head structure of the present invention.
图中:1.侧梁;2.轴周环;3.立柱轴;4.记忆变形侧梁;5.记忆变形正梁;6.正梁;7.开放窗口;8.凸头结构;9.卡槽结构。In the figure: 1. Side beam; 2. Shaft ring; 3. Column shaft; 4. Memory deformation side beam; 5. Memory deformation front beam; 6. Front beam; 7. Open window; 8. Protruding head structure; 9 .Card slot structure.
具体实施方式Detailed ways
实施例1:Example 1:
脊柱前路融合术,在微创条件下或者开放条件下,达到脊柱前方,确认病椎,再次椎间盘,磨除骨质,充分减压。取合适大小的未变形本发明一个,置入椎间隙中,此时,记忆变形侧梁4和记忆变形正梁5在体内慢慢变直,变成图2中模样,在C臂X光机下确认位置可以后,通过特制的配套漏斗,植入人工骨或者自体骨。Anterior spinal fusion, under minimally invasive or open conditions, reaches the front of the spine, confirms the diseased vertebra, re-discs, grinds bone, and fully decompresses. Take an undeformed one of the present invention of a suitable size and place it in the intervertebral space. At this time, the memory
实施例2:Example 2:
经椎弓根经椎间盘斜向螺钉内固定术联合椎间融合器置入术,在内镜下或者开放传统手术条件下,通过后方手术入路或者通过经椎间孔手术入路,摘除椎间盘,磨除上下终板,减压充分后,取合适大小的未变形本发明一个,置入椎间隙中,此时,记忆变形侧梁4和记忆变形正梁5在体内慢慢变直,变成图2中模样,在C臂X光机下确认位置可以后,通过特制的配套漏斗,植入人工骨或者自体骨。Transpedicular and intervertebral disc oblique screw fixation combined with intervertebral cage placement, under endoscopic or open traditional surgical conditions, through the posterior surgical approach or through the transforaminal surgical approach, the intervertebral disc is removed, Grind off the upper and lower endplates, and after the decompression is sufficient, take an undeformed one of the present invention of a suitable size and place it in the intervertebral space. As shown in Figure 2, after confirming the position under the C-arm X-ray machine, artificial bone or autologous bone is implanted through a special matching funnel.
实施例3Example 3
脊柱后路减压四钉二棒内固定术联合椎间融合器置入术,在内镜下或者开放传统手术条件下,通过后方手术入路或者通过经椎间孔手术入路,摘除椎间盘,磨除上下终板,减压充分后,取合适大小的未变形本发明一个,置入椎间隙中,此时,记忆变形侧梁4和记忆变形正梁5在体内慢慢变直,变成图2中模样,在C臂X光机下确认位置可以后,通过特制的配套漏斗,植入人工骨或者自体骨。Posterior spinal decompression with four screws and two rods and internal fixation combined with intervertebral cage placement, under the condition of endoscopic or open traditional surgery, through the posterior surgical approach or through the transforaminal surgical approach, the intervertebral disc is removed, Grind off the upper and lower endplates, and after the decompression is sufficient, take an undeformed one of the appropriate size and place it in the intervertebral space. As shown in Figure 2, after confirming the position under the C-arm X-ray machine, artificial bone or autologous bone is implanted through a special matching funnel.
实施例4:Example 4:
行脊柱侧方入路椎间融合术,在内镜下或者开放传统手术条件下,通过侧方腰部肌肉或者肌间隙入路,摘除椎间盘,磨除上下终板,减压充分后,取合适大小的未变形本发明一个,置入椎间隙中,此时,记忆变形侧梁4和记忆变形正梁5在体内慢慢变直,变成图2中模样,在C臂X光机下确认位置可以后,通过特制的配套漏斗,植入人工骨或者自体骨。Under the condition of endoscopic or open traditional surgery, the intervertebral disc is removed through the lateral lumbar muscle or muscle space approach, and the upper and lower endplates are removed. After sufficient decompression, the appropriate size is selected. The undeformed one of the present invention is placed in the intervertebral space. At this time, the memory
Claims (3)
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| CN201811176168.2A CN109157311B (en) | 2014-07-27 | 2014-07-27 | A minimally invasive implantable shape memory interbody cage |
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| CN201410358699.9A CN105310803B (en) | 2014-07-27 | 2014-07-27 | A minimally invasive shape memory intervertebral fusion device |
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| CN106510906B (en) * | 2017-01-01 | 2019-01-25 | 常州华森医疗器械有限公司 | The support construction portion of POROUS TITANIUM Invasive lumbar fusion device |
| CN106667626B (en) * | 2017-01-01 | 2019-02-01 | 常州华森医疗器械有限公司 | POROUS TITANIUM Invasive lumbar fusion device and preparation method thereof |
| CN112674916B (en) * | 2020-12-17 | 2022-12-27 | 湖南华翔医疗科技有限公司 | Intervertebral fusion cage |
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| US6019793A (en) * | 1996-10-21 | 2000-02-01 | Synthes | Surgical prosthetic device |
| WO2001001895A1 (en) * | 1999-07-02 | 2001-01-11 | Petrus Besselink | Reinforced expandable cage |
| US6991653B2 (en) * | 2002-03-21 | 2006-01-31 | Sdgi Holdings, Inc. | Vertebral body and disc space replacement devices |
| US20040010315A1 (en) * | 2002-03-29 | 2004-01-15 | Song John K. | Self-expanding intervertebral device |
| CN2579357Y (en) * | 2002-11-29 | 2003-10-15 | 王建华 | Lumber vertebrae anastomat |
| CN1188091C (en) * | 2003-05-01 | 2005-02-09 | 东南大学 | Microwound vertebral body fusion device made of shape memory alloy |
| US7344564B2 (en) * | 2004-06-08 | 2008-03-18 | Spinal Generations, Llc | Expandable spinal stabilization device |
| CN2910134Y (en) * | 2005-11-24 | 2007-06-13 | 袁文 | Self-opening Ni-Ti memory alloy interspinous fusion device for cervical vertebrae |
| US20070233255A1 (en) * | 2006-03-06 | 2007-10-04 | Vermillion Technologies, Llc | Intervertebral disc replacement prosthesis |
| US8808380B2 (en) * | 2007-08-27 | 2014-08-19 | William Casey Fox | Method and apparatus for an osteotomy fixation or arthrodesis cage |
| CN201551419U (en) * | 2009-11-19 | 2010-08-18 | 甘肃国脉生物科技有限责任公司 | Memory alloy vertebral body bracket |
| CN201558198U (en) * | 2009-11-24 | 2010-08-25 | 孙正义 | Memory alloy anterior lumbar interbody fusion device |
| JP5885270B2 (en) * | 2010-10-05 | 2016-03-15 | ロリオ,モーガン,ピー. | Intervertebral device and method of use |
| KR101052833B1 (en) * | 2010-10-28 | 2011-07-29 | 박경우 | Flexible intervertebral cage |
| CN101999951B (en) * | 2010-12-04 | 2013-09-11 | 兰州西脉记忆合金股份有限公司 | Memory alloy artificial cervical intervertebral disc |
| AU2012236149B2 (en) * | 2011-03-30 | 2016-05-19 | Trinity Orthopedics, Llc | Articulating interbody cage and methods thereof |
| EP2606860B1 (en) * | 2011-12-22 | 2016-07-20 | Biedermann Technologies GmbH & Co. KG | Expandable intervertebral implant |
| KR101371418B1 (en) * | 2013-03-06 | 2014-03-25 | (주)강앤박메디컬 | Intervertebral fusion device |
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| CN105310803B (en) | 2018-11-23 |
| CN109157311A (en) | 2019-01-08 |
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