WO2018201636A1 - 一种成结医用缝线及其成结方法 - Google Patents
一种成结医用缝线及其成结方法 Download PDFInfo
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- WO2018201636A1 WO2018201636A1 PCT/CN2017/096121 CN2017096121W WO2018201636A1 WO 2018201636 A1 WO2018201636 A1 WO 2018201636A1 CN 2017096121 W CN2017096121 W CN 2017096121W WO 2018201636 A1 WO2018201636 A1 WO 2018201636A1
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- flexible anchor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
Definitions
- the invention belongs to the technical field of medical sutures, relates to a knotted medical suture and a method for forming the same, and particularly relates to a knotted medical suture for repairing soft tissue and a method for forming the same.
- the line anchor is to string the anchor on the suture and ensure that the anchor can slide freely on the left and right sides of the suture.
- anchors for wire anchoring devices are basically made of polymer, metal or biodegradable compounds. These anchors usually require surgical holes of the same diameter as themselves to be placed in the bone. If the device is loose, This may lead to the potential danger of a hard device in the joints of the human body, which may cause the patient to develop the risk of arthritis. Some polymerization devices, such as those made of polylactic acid, may weaken the bone and induce fractures in the patient. Metal devices can cause dispersion on the MRI, making subsequent MRF inaccurate.
- a soft anchoring implant made of a biaxial braid is mentioned in the patent CN104053406A.
- a suture anchor made of a tubular textile material is mentioned in the patent CN105163673A.
- a flexible fixing member made of a suture is mentioned in the patent CN104869920A.
- Wired anchors that use only flexible, resilient materials in repair have many advantages.
- the implant requires only a small hole, the material is not easily broken and soft, and there is no risk of turbulent joints in the hard device.
- MRI can be used after surgery, tissue dissociation is small, stronger fixation strength and less fracture risk.
- the advantage of the flexible anchor is that the diameter before and after implantation will change greatly.
- the diameter after implantation is at least 30% larger than that before implantation, which will greatly increase the fixing strength of the anchor and make it less likely to fall off.
- a soft anchoring implant made of a biaxial braid is mentioned. Similar to the technical solution of the present invention, the knotting scheme is to compress the columnar flexible braid with a suture and enlarge the braided cross of the columnar flexible braid. Angle, the flexible braid is compressed up and down, and finally resembles a spherical knot. This way of knotting, if you want to increase the diameter of the knot Increasing the fixation strength requires increasing the length or diameter of the soft anchor implant, which means that the diameter or length of the pre-drilled surgical hole needs to be increased, which increases the damage to the human body.
- the technical problem to be solved by the present invention is to increase the fixing strength of the flexible anchor without increasing the damage to the human body, to provide a method for forming a medical suture and a method for forming the same, and particularly to provide a knot for repairing soft tissue.
- Medical suture and its method of forming When anchoring is used in human soft tissue repair surgery, anchor implantation requires drilling holes or self-tapping holes on the bone, which may damage the human bone and affect the recovery of the patient.
- the anchor is required to be small in volume and strong in fixation, especially in the repair of some small joints or joint lips of the human body.
- the traditional anchor can not meet this requirement.
- the development of flexible anchor is to solve this technical problem.
- the flexible anchor is made of flexible material variability, implanted in a slender, small diameter shape, and passed after implantation. External forces force the anchor to form a knot and act as a fix. Achieve a small size, strong fixed strength.
- the invention provides a method for forming a medical suture and forming a spiral knot, which is a new flexible anchor.
- the knot shape of the flexible anchor is primarily determined by the manner in which the suture passes through the flexible anchor, and the present invention utilizes the softness of the suture as a flexible anchor.
- a knotted medical suture according to the present invention comprises a flexible anchor and a load suture, the flexible anchor being a columnar flexible material; the load suture is semi-circularly wrapped around the flexible anchor;
- the load suture is composed of five parts in sequence: a wire head, a spiral winding section 1, a connecting section, a wire head 2 and a spiral winding section 2; the spiral winding section 1 has the same threading direction as the spiral winding section 2 and the spiral direction is uniform;
- the connecting section connects the spiral winding section 1 and the spiral winding section 2; the wire head 1 and the wire head 2 respectively pass through the flexible anchor inside from the two ends of the connecting end;
- the spiral winding section has the same angle and direction as the spiral winding section.
- the specific operation mode of the spiral anchor of the flexible anchor firstly determine the diameter R after the knot of the required flexible anchor and the diameter R 0 of the flexible anchor in the column before threading, and then select two threading points at the end of the flexible anchor as close as possible.
- the two threading points need to be parallel to the longitudinal direction of the column flexible anchor, and the distance between the two threading points is (RR 0 ).
- both ends of the load suture (line head 1 and head 2) start from 0° point through the inside of the columnar flexible anchor to 180 ° point, then left-handed to 270 ° point (or right-handed to 90 ° point), from the inside of the flexible anchor to form the first spiral winding section, the length of this winding section is (2 ⁇ R), then load the suture
- the two ends (the first end of the thread and the second end of the thread) are respectively rotated left around the cylindrical flexible anchor to a point of 270° (or right-handed to a 90° point), and pass through the inside of the flexible anchor to form a second spiral winding section.
- the length is (2 ⁇ R), and the subsequent threading is in accordance with the second spiral winding section. Threading way.
- the flexible anchor is a columnar braid, a columnar flexible rubber or a plastic, the length is 10 mm to 30 mm, and the diameter is controlled to be 0.3 mm to 5 mm; the columnar flexible anchor is selected from a textile material.
- the suture can be cut into 10mm ⁇ 30mm segments, and the ends of the flexible anchor need to be sealed to prevent the port from loosening.
- the sealing method is selected by high temperature hardening, glue bonding or filament stitching.
- the load suture is not limited to one, and two, three or more sutures in parallel may be selected.
- the spirally wound section is left-handed or right-handed together with the spirally wound section.
- the connecting section, the first head and the second end, respectively, pass from the flexible anchor through two sections of the connecting section, and the connecting section is parallel to the longitudinal direction of the cylindrical flexible anchor.
- the invention also provides a method for forming a knotted medical suture: after the flexible anchor is restrained, the thread head 1 and the thread head 2 of the load suture are simultaneously pulled, and the flexible anchor is deformed into a spiral knot. .
- the effective area of the spiral knot is 2 to 4 times the maximum circumscribed circle area of the flexible anchor section.
- the spiral knot of the invention has a spiral structure by changing the outer shape structure of the flexible body, and the maximum outer diameter of the spiral structure is 2 to 4 times larger than that before the knot formation, and the structure is stacked up and down, which greatly increases the stability of the knot. It enhances the fixation strength and stability in the bone hole.
- the technical solution of the present invention is to directly distort the shape of the columnar flexible braid, and spirally rotate to form a spiral knot.
- the structure of the spiral knot is stacked up and down and stabilized, and the diameter of the spiral is at least twice or more than that of the columnar shape.
- the spiral structure is more stable and the diameter after the knot is large.
- the thickness is thick, which provides a larger and more stable fixing force.
- Figure 1 is a schematic view of the threading of a medical suture
- FIG. 2 is a schematic view showing a spiral structure of a medical suture
- Figure 3 is a schematic view of the inserted medical suture loading inserter
- Figure 4 is a schematic view showing the implantation of a medical suture device
- Figure 5 is a schematic view showing the formation of a knotted medical suture after implantation
- 101 is a flexible anchor
- 102 is loaded with suture
- 103 is an outer tube (metal hollow rod)
- 104 is an inner tube (metal hollow rod)
- 105 is pre-drilled on the bone
- 201 is a threaded head of the load suture
- 203 and 206 are two adjacent sections of the spiral wound section of the load suture
- 204 and 207 are two adjacent sections of the spiral wound section of the load suture
- 205 is a load suture connection. segment.
- FIG. 1 is a threading manner of a flexible anchor.
- the diameter R (see FIG. 2) and the diameter R 0 of the columnar flexible anchor are clearly required before the threading.
- the flexible anchor diameter is positioned clockwise in a 360° linear point, and the two end connecting lines of 205 are 0° around the diameter of 101, and the length of 205 is ( RR 0 ) is parallel to the length direction of 101, and 205 is as close as possible to one end of 101.
- 201 and 202 first pass through the inside of 101 from both ends of 205, respectively, 201 and 202 start from 0°, pass through 101, pass through 180°, and then twist right to 90°.
- FIG. 3 is a schematic view of a medical suture inserted into an inserter.
- the implantation of a medical suture can be realized by means of an inserter.
- the flexible anchor 101 for forming a medical suture is plugged by a syringe-like piston principle.
- the metal hollow rod 103 is inserted into the metal hollow rod 104 having a smaller inner diameter than the flexible anchor 101, and the flexible anchor 101 is placed on the head of the 103. Both ends of the load suture extend from the tail of the metal hollow rod 104. Assembly into a medical suture device
- FIG. 4 is a schematic diagram of implantation of a medical suture device, and a medical suture is used in a surgical operation.
- the device first needs to insert the medical suture device into the surgical hole, then the metal hollow rod 103 retreats, the metal hollow rod 104 does not move, the flexible anchor 101 is implanted into the surgical hole, and then the load suture is extended to extend out of the hollow rod.
- the flexible anchor will become a spiral knot and the implant will be successful (see Figure 5).
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Abstract
一种成结医用缝线及其成结方法,包括柔性锚(101)和负载缝合线(102),所述柔性锚(101)为柱状柔性物;所述负载缝合线(102)半包围螺旋缠绕于柔性锚(101)。一种成结医用缝线的成结方法:将所述柔性锚(101)限位后,同时拉动所述负载缝合线(102)的线头一(201)和线头二(202),所述柔性锚(101)即变形为螺旋状结;所述螺旋状结的有效面积为所述柔性锚(101)截面最大外接圆面积的2~4倍。成结医用缝合线是一种柔性的带线锚钉,柱状体时植入,植入后变成螺旋结固定在骨内,成为固定点,被外科医生用来修复人体损伤的软组织。和现有技术相比,它成结后的直径更大,结构更稳定,能提供更大和更稳定的固定强力。
Description
本发明属医用缝合线技术领域,涉及一种成结医用缝线及其成结方法,特别是涉及一种用于修复软组织的成结医用缝线及其成结方法。
软组织的损伤多数是肌腱、韧带或其他软组织从骨完全或部分脱离,主要发生在人体的关节部位,由于运动过度或者随着年龄偏大,软组织受力过度造成的损伤,通常需要外科手术。目前外科手术中常用修复方式是用带线锚钉装置来把脱离的软组织固定到骨。
带线锚钉就是把锚钉串在缝合线上,并保证锚钉能在缝合线上左右自由滑动。
目前常用的带线锚钉装置的锚钉基本都是采用聚合物、金属或可生物降解的化合物,这些锚钉植入通常需要和本身直径差不多的手术孔,才能放置入骨内,若装置松动,就可能引发在人体关节中出现硬装置的潜在危险,有可能使患者发展成关节炎的风险,有些聚合装置,比如聚乳酸所制成的可能消弱骨,诱发患者骨折。金属装置可能引起在MRI上的分散,使后续的MRF不准确。
同时对于人体如手、足等小关节损伤的修复,现有的硬性锚钉体积太大,无法植入,而柔性锚钉体积小,固定强力高,很好的解决这一技术难题。
为解决这些问题,开发了用柔性,有弹性的材料制成的带线锚钉
在专利CN104053406A中提到了用双轴编织物制成软锚固植入物。
在专利CN105163673A中提到了用管状纺织材料制成的缝线锚。
在专利CN104869920A中提到了用缝合线制成柔性固定部件。
这些专利提到的都用柔性材料制成的带线锚钉。
在修复中仅使用柔性、有弹性的材料的带线锚钉具有许多优势。
植入仅需要更小的孔,材料不易破碎且柔软,不会发生硬装置涕流关节内的风险,术后可以使用MRI,组织排异性小,更强的固定强力以及更小的骨折风险。
柔性锚钉的优势还在于,植入前后的直径会发生很大的变化,植入后的直径至少比植入前大30%,这样会大大增加锚钉的固定强力,使其更不易脱落。
在专利CN104053406A中提到了用双轴编织物制成软锚固植入物,与本发明技术方案类似,它的成结方案是利用缝合线压缩柱状柔性编织物,加大柱状柔性编织物的编织交叉角度,把柔性编织物上下压缩,最终类似球形的结。这种成结方式,如果要通过增加成结的直径来
增加固定强力就需要增加软锚植入物的长度或直径,这就意味着需要增加预钻手术孔的直径或长度,增加了对人体的损伤。
发明内容
本发明所要解决的技术问题是在不增加对人体损伤的基础上增加柔性锚钉固定强力,提供一种成结医用缝线及其成结方法,特别是提供一种用于修复软组织的成结医用缝线及其成结方法。在人体软组织修复手术中使用锚定固定时,锚钉植入需要在骨上钻孔或自攻孔,这就对人体骨有损伤,影响病人的恢复。临床上就要求锚钉体积小,固定强力大,特别是在人体一些小关节或关节盂唇的修复时,更是如此。而传统锚钉满足不了这个要求,柔性锚钉的开发就是为了解决这个技术难题,柔性锚钉就是利用柔性的材料可变性的特性,以细长、小直径的形状植入,在植入后通过外力迫使锚钉变形成结,起固定作用。实现了体积小,固定强力大。
本发明提供一种用成结医用缝合线及成螺旋结的方法,是一种新的柔性锚钉。柔性锚的成结形状主要由缝合线穿过柔性锚的方式来决定,本发明利用缝合线柔软的特性,把它作为柔性锚。
本发明的一种成结医用缝线,包括柔性锚和负载缝合线,所述柔性锚为柱状柔性物;所述负载缝合线半包围螺旋缠绕于柔性锚;
所述负载缝合线由五部分依次构成:线头一、螺旋缠绕段一、连接段、线头二和螺旋缠绕段二;所述螺旋缠绕段一与螺旋缠绕段二的穿线方向相同且螺旋方向一致;
所述连接段连接所述螺旋缠绕段一和螺旋缠绕段二;线头一和线头二分别从连接端的两端开始从柔性锚内部穿过;
所述螺旋缠绕是指所述负载缝合线的线头一和线头二在所述柔性锚上螺旋绕行一定角度后从所述柔性锚的内部穿过,然后在绕行相同的角度再从所述柔性锚的内部穿过,以此类推;
所述螺旋缠绕段一与螺旋缠绕段二绕行的角度和方向一致。
柔性锚的成螺旋结的具体操作方式:在穿线前先确定所需要柔性锚成结后的直径R和柱状时柔性锚的直径R0,然后在尽量靠近柱状柔性锚的一端选取两个穿线点作为负载缝合线的两端(线头一和线头二)穿柔性锚的起始点,这两个穿线点连线需要和柱状柔性锚长度方向平行,且两个穿线点的距离为(R-R0),以2个穿线点为0°点,绕柱状柔性锚顺时针方向有360°点,然后负载缝合线的两端(线头一和线头二)分别开始从0°点穿过柱状柔性锚内部到180°点,然后左旋到270°点(或右旋到90°点),从柔性锚内部穿过到,形成第一个螺旋缠绕段,这个缠绕段的长度且为(2πR),然后负载缝合线的两端(线头一和线头二)再分
别绕柱状柔性锚左旋到270°点(或右旋到90°点),从柔性锚内部穿过,形成第二个螺旋缠绕段,这个缠绕段的长度且为(2πR),后续穿线按照第二个螺旋缠绕段穿线方式来。
作为优选的技术方案:
如上所述的一种成结医用缝线,所述螺旋缠绕段一与所述螺旋缠绕段二缠绕于所述柔性锚的每小段长度相等且等于成结后柔性锚的最大外围周长。
如上所述的一种成结医用缝线,所述柔性锚为柱状编织物、柱状柔性橡胶或塑料,长度为10mm~30mm,直径控制在0.3mm~5mm;柱状柔性锚选用纺织材料编织缝合线的,缝合线可以切割成10mm~30mm每段,且柔性锚的两端需要封口以防端口松散,封口方式选择高温硬化、胶水粘合或细丝缝合方式。
如上所述的一种成结医用缝线,所述负载缝合线为5-0~7#医用缝合线。所述的负载缝合线不限于一根,可以选用并行的两根、三根或三根以上的缝合线。
如上所述的一种成结医用缝线,所述螺旋缠绕段一的螺旋参数:绕行角为45°~135°。
如上所述的一种成结医用缝线,所述螺旋缠绕段一与所述螺旋缠绕段二同为左旋或同为右旋。
如上所述的一种成结医用缝线,所述连接段,线头一和线头二分别从连接段的两段开始从柔性锚穿过,且连接段与柱状柔性锚长度方向平行。
如上所述的一种成结医用缝线,所述柔性锚和所述负载缝合线的材质为分子量在50~300万之间的高分子量聚乙烯、聚酯或尼龙。
本发明还提供了一种成结医用缝线的成结方法:将所述柔性锚限位后,同时拉动所述负载缝合线的线头一和线头二,所述柔性锚即变形为螺旋状结。
如上所述的成结方法,所述螺旋状结的有效面积为所述柔性锚截面最大外接圆面积的2~4倍。
本发明的螺旋结,通过改变柔性体的外形结构,使其成螺旋结构,螺旋结构的最大外围直径比成结前要大2~4倍,并且结构上下堆叠,很好的增加了结的稳定性,使其在骨孔内的固定性强力和稳定性增强。
本发明的技术方案是直接扭曲柱状柔性编织物的形状,使其螺旋旋转形成螺旋结,螺旋结的结构上下堆叠,稳定,螺旋的直径至少是柱状时的2倍以上。
相比球形结,螺旋结构更稳定,成结后的直径大。厚度厚,这样就能提供更大和更稳定的固定强力。
图1为医用缝合线穿线示意图;
图2为医用缝合线的成螺旋结构示意图;
图3为成结医用缝合线装入插入器示意图;
图4为成结医用缝合装置植入示意图;
图5为成结医用缝合线植入后成结示意图;
其中,101为柔性锚,102负载缝合线,103为外管(金属空心杆),104内管(金属空心杆),105骨上的手术预钻孔,201为负载缝合线的线头一,201为负载缝合线的线头二,203和206为负载缝合线的螺旋缠绕段一相邻的两段,204和207为负载缝合线的螺旋缠绕段二相邻的两段,205为负载缝合线连接段。
下面结合具体实施方式,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明讲授的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1:图1是柔性锚的穿线方式,在穿线线前明确需要该柔性锚成结后的直径R(见图2)和柱状柔性锚的直径R0。以柱状柔性锚以中心轴为中心线,把柔性锚直径外围沿顺时针方向定位成360°的线性点,以205的两个端点连接线为101直径外围的0°点,205的长度为(R-R0)且与101长度方向平行,205尽量靠近101的一端。201和202首先从205的两端分别开始从101内部穿过,201和202从0°点开始穿入,从101内部穿过,180°点穿出,然后右旋到90°点穿入,从101内部穿过,270°点穿出,分别形成两个螺旋缠绕段203和204,203和204的长度为(2πR),然后再右旋到90°点穿入,从101内部穿过,270°点穿出,分别形成两个螺旋缠绕段206和207,206和207的长度为(2πR)。此时穿线完成。如果此时还没有穿线到柔性锚101的另一个端点,则按照206和207的形成方式继续穿线,直到穿线到柔性锚的另一个端点.
实施例2:图3是成结医用缝合线装入插入器示意图,成结医用缝合线的植入需要借助插入器才能实现,利用类似注射器活塞原理,把成结医用缝合线的柔性锚101塞入金属空心杆103,然后再插入内径比柔性锚101直径小的金属空心杆104,把柔性锚101顶在103的头部,负载缝合线的两端都从金属空心杆104的尾部延伸出去,组装成了成结医用缝合线装置
实施例3:图4是成结医用缝合线装置植入示意图,在外科手术中使用成结医用缝合线
装置,首先需要把成结医用缝合线装置插入手术孔中,然后金属空心杆103后退,金属空心杆104不动,把柔性锚101植入手术孔,然后拉动负载缝合线延伸出空心杆的两端(线头一和线头二),柔性锚就会成螺旋结,植入成功(见图5)。
Claims (10)
- 一种成结医用缝线,其特征是:包括柔性锚和负载缝合线,所述柔性锚为柱状柔性物;所述负载缝合线半包围螺旋缠绕于柔性锚;所述负载缝合线由五部分依次构成:线头一、螺旋缠绕段一、连接段、线头二和螺旋缠绕段二;所述螺旋缠绕段一与螺旋缠绕段二的穿线方向相同且螺旋方向一致;所述连接段连接所述螺旋缠绕段一和螺旋缠绕段二;线头一和线头二分别从连接端的两端开始从柔性锚内部穿过;所述螺旋缠绕是指所述负载缝合线的线头一和线头二在所述柔性锚上螺旋绕行一定角度后从所述柔性锚的内部穿过,然后再绕行相同的角度再从所述柔性锚的内部穿过,以此类推;所述螺旋缠绕段一与螺旋缠绕段二绕行的角度和方向一致。
- 根据权利要求1所述的一种成结医用缝线,其特征在于,所述螺旋缠绕段一与所述螺旋缠绕段二缠绕于所述柔性锚的每段长度相等且等于成结后柔性锚的最大外围周长。
- 根据权利要求1所述的一种成结医用缝线,其特征在于,所述柔性锚为柱状编织物、柱状柔性橡胶或塑料,长度为10mm~30mm,直径控制在0.3mm~5mm;且柔性锚的两端需要封口以防端口松散,封口方式选择高温硬化、胶水粘合或细丝缝合方式。
- 根据权利要求1所述的一种成结医用缝线,其特征在于,所述负载缝合线为5-0~7#医用缝合线。
- 根据权利要求1所述的一种成结医用缝线,其特征在于,所述螺旋缠绕段一的螺旋参数:绕行角为45°~135°。
- 根据权利要求1所述的一种成结医用缝线,其特征在于,所述螺旋缠绕段一与所述螺旋缠绕段二同为左旋或同为右旋。
- 根据权利要求1所述的一种成结医用缝线,其特征在于,所述连接段,线头一和线头二分别从连接段的两段开始从柔性锚穿过,且连接段与柱状柔性锚长度方向平行。
- 根据权利要求1所述的一种成结医用缝线,其特征在于,所述柔性锚和所述负载缝合线的材质为分子量在50~300万之间的高分子量聚乙烯、聚酯或尼龙。
- 如权利要求1所述的一种成结医用缝线的成结方法,其特征是:将所述柔性锚限位后,同时拉动所述负载缝合线的线头一和线头二,所述柔性锚即变形为螺旋状结。
- 根据权利要求9所述的成结方法,其特征在于,所述螺旋状结的有效面积为所述柔性锚截面最大外接圆面积的2~4倍。
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