CN105250050B - A non-tension suspension system with - Google Patents

A non-tension suspension system with Download PDF

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CN105250050B
CN105250050B CN 201510703366 CN201510703366A CN105250050B CN 105250050 B CN105250050 B CN 105250050B CN 201510703366 CN201510703366 CN 201510703366 CN 201510703366 A CN201510703366 A CN 201510703366A CN 105250050 B CN105250050 B CN 105250050B
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CN 201510703366
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CN105250050A (en )
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王国帅
赖奎霖
郭泽跃
袁玉宇
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深圳迈普再生医学科技有限公司
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Abstract

本发明公开一种无张力悬吊带系统。 The present invention discloses a system with a tension-free suspension. 所述无张力悬吊带系统包括吊带主体和包覆吊带主体表面的护套;所述吊带主体由纤维膜层构成;所述吊带主体设置有由多个通孔组成的镂空支架结构;所述护套的上表面或下表面上设置有孔。 The tension-free suspension system includes a sheath with a body harness and body harnesses coated surface; said strap body consists of a fiber layer; said strap body is provided with a hollow frame structure composed of a plurality of through-holes; said guard sleeve is provided with a hole on the upper or lower surface. 本发明所述的无张力悬吊带系统,通过对吊带主体和护套结构的设计,提高了吊带产品的自体化性能,通过在护套的一个面上设置孔,减少护套与人体组织的接触面积,从而显著减少护套取出时产生的阻力,大大提高了护套取出时的方便性和操作性。 Without contacting the suspension with the present invention, the tension system, and the body harness through the design of the jacket structure, improves the performance of the sling autologous product through a hole provided in the surface of the sheath, the sheath and the body tissue to reduce area, thereby significantly reducing the resistance generated when the sheath is removed, greatly improving the convenience and operability when the sheath removed.

Description

一种无张力悬吊带系统 A non-tension suspension system with

技术领域 FIELD

[0001] 本发明属于植入医疗领域,具体涉及一种用于治疗压力性尿失禁的无张力悬吊带系统。 [0001] The present invention belongs to the field of medical implants, particularly relates to a system with a tension-free suspension for the treatment of stress urinary incontinence.

背景技术 Background technique

[0002] 压力性尿失禁(Stress Urinary Incontinence,SUI):又称张力性尿失禁,是因腹内压增高,直立或行走时,由于尿道括约肌弛缓和无力形成的尿液不随意流出的疾病。 [0002] Stress urinary incontinence (Stress Urinary Incontinence, SUI): also known as stress urinary incontinence, is due to intra-abdominal pressure, erect or walking, since the weak urethral sphincter relaxation, and urine outflow formed involuntary disease. 发生在青少年时,多是先天性括约肌缺如或功能不佳,中年患者多由于损伤,生产造成损伤和肌张力减退,老年患者由于肌肉萎缩所致,此外久病后体弱,营养不良,糖尿病等也可导致本病的发生。 Occurs in young people, mostly congenital absence or sphincter dysfunction, and middle-aged patients with multiple injuries due to produce damage and hypotonia, in elderly patients due to muscle atrophy caused, in addition frail after a long illness, malnutrition, diabetes can also lead to the occurrence of the disease. 女性尿失禁的中位年龄为50〜60岁,发病率为10%〜40%。 The median age of female urinary incontinence was 50 to 60 years of age, the incidence rate of 10% ~ 40%. 尿失禁常会导致患者丧失自尊、尴尬,使患者的社会活动及性活动减少,长期将导致患者抑郁,失禁也是将老年人送交护理机构的最普遍原因。 Urinary incontinence often leads patients lose self-esteem, embarrassment, the patient's social activities and activities to reduce the long-term will lead to patients with depression, incontinence is the most common cause will be sent to the elderly care facility. 目前治疗SUI最有效、最彻底的方法是进行无张力吊带手术。 The most effective current treatment of SUI, most thorough method is tension-free sling procedure. 吊带治疗压力性尿失禁的原理是基于“吊床理论”,该理论认为盆腔内筋膜和阴道前壁组成一个“吊床”,尿道位于其上,当吊床功能缺陷时就会引起压力性尿失禁的发生。 Principle tape for surgical treatment of stress urinary incontinence is based on the "hammock theory," the theory that the pelvic fascia and the anterior vaginal wall to form a "hammock", urethra located on its, when the hammock functional defects can cause stress urinary incontinence occur. 吊带植入后吊带主体两端固定于肌肉和筋膜中,并对尿道起到承托的作用,使其解剖位置回复正常。 After implantation of the sling strap is fixed to the ends of the body muscles and fascia, and play a role in supporting the urethra, making it back to normal anatomical position.

[0003] 现有吊带产品主要为编织聚丙烯制成的,但该类产品长期植入人体会出现变形, 导致侵蚀、暴露、感染等并发症,侵蚀是指现有的吊带在植入后容易向膀胱、输尿管侵犯,且范围会渐渐扩大,暴露于腔内的吊带面积范围会逐渐变大,从而引起尿路刺激症、反复泌尿系感染、尿痿等相应部位的症状。 [0003] harness existing products are mainly made of woven polypropylene, but these products will be implanted in the body long-term deformation, leading to erosion, exposure, infection and other complications, erosion refers to the existing harness easily after implantation the bladder, ureter violations, and will gradually expand the range, the range of the area exposed to the harness cavity will gradually become larger, causing urinary tract irritation, recurrent urinary tract infection symptoms, and the like corresponding parts of the urinary atrophy. 使患者出现阴道异常分泌物增多、流血、性交困难、疼痛等。 The increase in patients with abnormal vaginal discharge, bleeding, dyspareunia, pain. 进一步地,由于吊带在植入过程需要穿插经过多个组织,常见地吊带易割伤经过的组织和脏器,容易造成疼痛甚至感染;而且,吊带在体内被牵引的过程中,脏器和组织与吊带发生的摩擦力,易使吊带发生形变并影响对“吊床”功能缺陷的修复的力学调节操作。 Further, since the harness is inserted through multiple implantation requires tissue, commonly harness easily cut through tissue and organ, is likely to cause pain or infection; and, in the process of the body harness is pulled, the organs and tissues and friction occurs sling, sling easy to make deform and affect the mechanical repair of "hammock" functional defects of the adjustment operation.

[0004] 纤维堆积增材制造技术是一种将聚合物溶液或熔融体在电学、力学、光学、生物或化学反应等作用下形成聚合物纤维,并有序或无序地堆积或沉积,构造成物件的方法。 [0004] The fiber stacking additive manufacturing technology is a polymer solution or a polymer melt formed fibers under the effect of electrical, mechanical, optical, biological or chemical reactions, and disorderly or orderly accumulation or deposition structure method to the object. 其中,静电纺丝、离心力纺丝、热恪喷丝、恪融电纺、电流体动力喷墨打印(EHD jet printing) 等技术都属于纤维堆积增材制造技术。 Wherein, electrospinning, centrifugal spinning, spinning heat Ke, Ke melt electrospinning, inkjet printing electrohydrodynamic (EHD jet printing) techniques are all bulk fiber additive manufacturing techniques. 纤维堆积增材制造技术是一种制备聚合物纤维简单而有效的加工方法,采用该方法制备的组织工程支架材料,在组织工程修复中得到了广泛的应用。 Bulk fiber additive manufacturing technology is a simple and effective preparation of a polymer fiber processing methods using tissue engineering scaffolds prepared by the method, it has been widely used in tissue engineering repair. 其制备的工程支架在一定程度上能有效地模拟天然细胞外基质结构,给细胞的生长和攀爬提供了良好的微环境,因而具有一定的仿生结构。 The preparation of scaffolds to some extent effective to mimic natural extracellular matrix structure, provides a good environment for the growth of micro-cells and climbing, which has a certain biomimetic structures. 目前这一特性使纤维堆积增材制造技术制备的纤维膜材料特别适用于生物医用领域,如生物膜、药物输送、组织工程等的支架材料等。 This feature currently deposited fiber material prepared Additive fiber membrane technology is particularly suitable for producing biomedical field, such as biofilms, drug delivery, tissue engineering scaffolds and the like. 尽管发明人此前已经有公开静电纺丝技术制备得到的无张力悬吊带,能够克服一些现有材料带来的并发症,由于并未对吊带产品的结构进行深入开发,因此依然存在改善的空间,以使病人获得生物相容性好,并发症低,便于手术操作的安全、有效的产品。 While the inventors have previously disclosed the preparation of electrospinning technology is tension-free sling, can overcome some of the complications brought about by existing materials, not due to the structure of the harness in-depth product development, there is still room for improvement, therefore, so that patients receive good biocompatibility, low complication of surgical procedures for safe and effective products.

发明内容 SUMMARY

[0005] 本发明的发明目的,在于克服现有技术的不足,提供一种用于治疗压力性尿失禁的无张力悬吊带系统。 [0005] The invention object of the present invention is to overcome the disadvantages of the prior art by providing a system with a tension-free suspension for the treatment of stress urinary incontinence. 所述无张力悬吊带系统包括纤维膜层构成的吊带主体,该吊带主体具有良好的与自体组织一体化的性能,以及包裹吊带主体表面的护套,通过该护套可以防止在手术过程中吊带对组织脏器的切割,减低吊带发生活动时对组织的摩擦,并显著减小护套取出时产生的阻力,大大提高了手术的方便性和操作性。 The system comprises a tension-free sling strap body made of a fiber layer, which has good body harness with autologous tissue integration performance, and a sheath wrapped sling body surface, through which the sheath can be prevented sling during surgery organs for cutting tissue, reduce the friction of the tissue when the event occurs harness, and significantly reduces resistance generated when the sheath removed, greatly improving the convenience and operability of the operation.

[0006] 本发明的上述目的通过如下技术方案予以实现: [0006] The object of the present invention to be achieved through the following technical solutions:

[0007] 一种无张力悬吊带系统,所述无张力悬吊带系统包括吊带主体和包覆吊带主体表面的护套;所述吊带主体由纤维膜层构成,所述吊带主体为由多个通孔组成的镂空网格状支架结构;所述护套的上表面或下表面上设置有孔。 [0007] A tension-free sling system with a tension-free suspension system comprises a sling body and a sheath covering the body surface of the strap; the strap body is constituted by a fiber layer, by a plurality of said strap body through hollow grid-like support structure aperture thereof; provided with a hole on the upper surface or lower surface of the sheath.

[0008] 优选地,所述吊带主体由具有仿生结构的纤维膜层构成。 [0008] Preferably, the sling body is made of fibers having a biomimetic layer structure.

[0009] 优选地,所述具有仿生结构的纤维膜层由纤维堆积增材制造技术制得。 [0009] Preferably, the film layer having a fibrous structure made from fibers biomimetic bulk additive manufacturing techniques.

[0010] 优选地,所述纤维膜层是通过静电纺丝技术制得。 [0010] Preferably, the film layer is a fiber obtained by electrospinning techniques. Won] 所述仿生结构是指模拟天然细胞外基质的结构。 Won] The biomimetic structure refers to a structure, mimic natural extracellular matrix.

[0012] 所述吊带主体上的通孔,可以通过激光雕刻、冲压、局部压熔、机械切割等方法制得。 [0012] The through hole in the harness body, can be obtained by laser engraving, stamping, partial pressure melting, and the like mechanical cutting methods. 由于吊带主体上有多个通孔,其排列类似网格状,因而吊带主体呈镂空网格状支架结构。 Since a plurality of through holes on the harness body which are arranged grid-like shape, and thus as a hollow body sling mesh-like support structure.

[0013] 上述吊带主体上的镂空网格状支架结构设计有利于诱导自体细胞生长,形成结缔组织,强化尿道周边组织,且吊带主体具有优化的强度与弹性,同时所述通孔的边缘设计成弧边或圆滑过渡可以避免了尖锐角对组织的刺激。 [0013] hollow lattice-like structure on the stent body harness design facilitates self-induced cell growth, formation of connective tissue, reinforced periurethral tissue and body harness with optimized strength and flexibility, while an edge of the through hole is designed to arc edge or a smooth transition to avoid a sharp angle stimulation of tissue. 现有技术为减少了吊带主体植入过程的阻力,通常选择在吊带主体的表面增加一个护套。 The prior art to reduce the resistance body sling implantation procedure, a sheath is generally selected to increase the surface of the sling body. 然而,现有的护套通常是一个完整的平面结构,其与人体组织的接触面很大,因此在取出护套的过程中,受到较大的阻力。 However, the conventional sheath is usually complete a planar structure, with the large body tissue contact surface, so during the removal of the sheath, being greater resistance. 发明人发现,在护套的一个面上设置孔,可以减少护套与人体组织的接触面积,能够显著减少护套取出时产生的阻力,同时也能减少吊带植入过程中的阻力,大大提高了吊带植入手术的方便性和操作性。 The inventors have found that a hole is provided in the surface of the sheath, the sheath can reduce the area of ​​contact with human tissue, can significantly reduce the resistance generated when the sheath removed, but also can reduce the resistance during implantation of the sling, greatly improved a sling implantation of convenience and operability.

[0014] 本发明中,吊带在人体内活动主要包括在手术时对吊带进行的牵引,以及在手术完毕后,将护套从吊带主体上分离取出。 [0014] In the present invention, the main activity in the human body harness comprising harness for traction during surgery and after surgery is completed, the sheath is removed from the separating body harness.

[0015] 护套上的孔的面积大小与护套取出时产生的阻力变化成反比,孔的面积越大,护套取出时的阻力越小。 [0015] The extraction resistance generated when the holes in the jacket area size varies inversely with the sheath, the greater the area of ​​the holes, the smaller the resistance of the sheath removed. 优选地,所述护套上的孔的总面积占其所在的护套上表面或下表面总面积的10%以上。 Preferably, the total area of ​​the holes of the sheath on the sheath or of its lower surface is located more than 10% of the total area of ​​the surface. 为了更好地达到减少活动过程中对人体组织的阻力,优选所述护套上的孔的总面积占其所在的护套上表面或下表面总面积的20%〜50%。 In order to achieve better resistance to the process of reducing the activity of the human tissue, or the lower surface of the total area of ​​holes on the sheath on the sheath preferably accounts for 20% ~ 50% where the total area of ​​the surface.

[0016] 所述护套可以是一体成型的护套,也可以由两个子护套组成。 The [0016] The sheath may be integrally molded sheath, the sheath may be composed of two sub-components. 为了更好地使护套与吊带主体分离,优选使用子护套的形式。 For a better separation of the sheath and the body harness, preferably using the sub-sheath form. 因而,优选地,所述护套包括对称分布在吊带主体左半部和右半部的第一护套和第二护套;所述第一护套和第二护套分别由吊带主体的两端向吊带主体的中央延伸,且第一护套和第二护套各自独立;所述第一护套和第二护套的上的孔位于同一面。 Thus, preferably, the sheath comprising a body harness symmetrically left and right first sheath and the second sheath portion; the first sheath and second sheath are made of two body harness end extending toward the center of the sling body, and the first sheath and second sheath are each independently; said first sheath and second sheath holes located on the same side.

[0017] 护套上的孔的数量可以是一个或多个。 [0017] The number of holes in the sheath may be one or more.

[0018] 优选地,设于第一护套或第二护套上的孔的数量为1〜5个。 Quantity [0018] Preferably, the first sheath or holes provided in the second sheath is ~ 5 months.

[0019] 优选地,所述第一护套与第二护套在其相邻一端存在间隙。 [0019] Preferably, the first sheath and second sheath at an end thereof adjacent a gap. 优选地,所述间隙的距离为0 · Icm〜10cm。 Preferably, the gap distance is 0 · Icm~10cm.

[0020] 为了达到较好的自体化效果,吊带的表面需要具有一定的粗糙度方便细胞的爬行及长入;另一方面,由于吊带植入位置为尿道和阴道前壁间隙,日常活动将导致吊带与柔软的尿道直接接触摩擦,当吊带表面粗糙度较大时,日常活动中,吊带将对尿道造成磨损,长时间的磨损将有可能导致尿道侵蚀的发生。 [0020] In order to achieve a better effect autologous, harness requires a certain surface roughness to facilitate cell ingrowth and reptiles; on the other hand, since the position of the sling implant anterior vaginal wall and the urethra gap, will result in daily activities urethral sling and a soft direct contact friction, when the sling surface roughness is large, daily activities, urethral sling will cause wear, long wear will likely lead to urethral erosion occurred. 优选地,所述吊带主体的上表面及下表面的粗糙度均为0. Iym〜50μπι。 Preferably, the sling body upper and lower surface roughness are 0. Iym~50μπι. 控制在此粗糙度的范围内,能更好地满足细胞爬行长入,并减少吊带对尿道的磨损。 Controlled roughness within this range, better meet the ingrowth cell migration, and to reduce wear on the sling to the urethra.

[0021] 吊带主体上的通孔的形状可以是规则的形状或不规则的形状。 [0021] The shape of the through hole in the harness body shape may be regular or irregular. 优选地,所述通孔的形状为圆形、椭圆形或设有倒角的多边形。 Preferably, the shape of the through hole is circular, elliptical or polygonal with chamfered.

[0022] 吊带主体上的通孔的孔径越大,越能提高无张力悬吊带与人体组织的相容性,优选地,所述通孔的孔径为1.5〜5mm。 [0022] The larger the diameter of the through hole on the strap body, the more we can improve the compatibility with the sling tension-free human tissue, preferably the passage hole is 1.5~5mm. 更优选地,所述通孔的孔径为3〜4.5mm。 More preferably, the diameter of the through-hole is 3~4.5mm. 更优选地,所述通孔的孔径为4mm。 More preferably, the diameter of the through hole is 4mm.

[0023] 吊带主体上的通孔的分布密度对无张力悬吊带的力学性能有一定的影响。 [0023] The distribution density of the through holes on the sling body has a certain influence on the mechanical properties of tension-free sling. 一般地,如果在吊带主体上的开孔量过多会导致无张力悬吊带的机械性能明显下降。 Generally, if the amount of opening in the sling body without excessive deterioration of mechanical properties sling tension decreased. 优选地,所述通孔在吊带主体上的分布密度为1〜10个/cm2。 Preferably, the distribution density of the through hole in the harness body is 1~10 number / cm2. 更优选地,所述通孔在吊带主体上的分布密度为2〜8个/cm2。 More preferably, the distribution density of the harness through hole in a body of 2~8 / cm2. 更优选地,所述通孔在吊带主体上的分布密度为3〜6个/cm2。 More preferably, the distribution density of the through hole in the harness body is 3 ~ 6 months / cm2.

[0024] 吊带主体的厚度越大,对周边组织的刺激越大,并发症发生几率越高,且病人术后将明显有异物感。 [0024] The larger the thickness of the strap body, the greater the irritation to the surrounding tissue, the higher the chance of complications, and the patient will be apparent after a foreign body sensation. 但过于薄的吊带将会对周边组织造成切割。 But too thin straps cut will cause the surrounding tissue.

[0025] 优选地,所述吊带主体的厚度为0. Imm〜I mm。 [0025] Preferably, the thickness of the body harness is 0. Imm~I mm. 优选吊带主体的厚度为0.2〜0.2 5mm; 由于吊带植入位置为阴道前壁,对于有性生活的使用者,较厚的吊带将使其感受到异物感及刺痛;当降低吊带的厚度为〇.25mm及以下时,病人异物感将显著降低。 The thickness of the harness body is preferably 0.2~0.2 5mm; because of the anterior vaginal wall sling implantation site, for users sexual life, will make it thicker straps and foreign body sensation felt tingling; when reducing the thickness of the sling when 〇.25mm and below, foreign body sensation, the patient will be significantly reduced.

[0026] 为了更便于医生进行手术操作,优选地,所述护套上设置有定位线。 [0026] In order to facilitate the surgical procedure doctors, preferably provided with a bit line on the sheath.

[0027] 对于一体成型的护套,为了更好地实现护套与吊带主体的分离,所述定位线可作为护套裁剪定位线,优选地,所述裁剪定位线与护套的在吊带主体的轴向上对称线重合。 [0027] For the integrally molded jacket, in order to better achieve the separation of the sheath body harness, may be used as the positioning line cut in the sheath body harness line positioning, preferably, the cut lines and positioning the sheath line of symmetry coincident in the axial direction.

[0028] 优选地,所述无张力悬吊带系统的两端设有导引线。 [0028] Preferably, the free ends of the tension belt system is provided with suspension guidewire. 导引线的设计,能更便于手术操作。 Design of the guide wire can be more convenient surgical procedure. 优选地,所述导引线与吊带主体的连接处设有用于保护导引线及方便穿刺的套管。 Preferably, said guide body wire harness and junction protection is provided for the guide wire and facilitate puncturing cannula. 导引线与吊带主体的连接处暴露在外,容易损坏,增设套管能提高连接处的寿命。 And the guide wire harness connection body exposed to the outside, easily damaged, can increase the life of an additional sleeve connection. 同时能够便于吊带系统穿过人体组织,植入人体体内。 At the same time it can facilitate harness system through human tissue implanted in the human body. 优选地,所述套管整体长度为5mm~20mm,更优选为I Omm〜16謹;套管直径为2mm〜8mm,优选3謹〜5謹。 Preferably, the entire length of the sleeve 5mm ~ 20mm, more preferably I Omm~16 wish; tube diameter of 2mm~8mm, preferably 3 ~ 5 wish to honor.

[0029] 所述无张力悬吊带系统的两端设有导引线和套管,所述套管的一端与护套及吊带主体连接,另一端呈锥体形;所述导引线的一端与护套及吊带主体连接,另一端穿过套管的锥体形端部开口延伸至套管外。 [0029] The free ends of the tension belt system is provided with a suspension and guide wire sleeve, one end of the sleeve and the sheath body harness, and the other end of the conical shape; end of the guide wire and and a harness connected to the sheath body, the other end of the cone-shaped end portion extends through the casing to the outer opening of the sleeve. 锥体形设计的套管,能减少穿刺过程的阻力。 Conical sleeve design, to reduce puncture resistance procedure.

[0030] 优选地,所述套管的一端与护套及吊带主体连接,另一端呈子弹头形状。 [0030] Preferably, one end of the sleeve and the sheath body harness and the other end as a bullet shape. 所述导引线的一端与护套及吊带主体连接,另一端穿过套管的子弹头形状的端部开口延伸至套管夕卜。 One end of said guide wire sheath and harness connector body, the end portion of the other end of the bullet-shaped opening extending through the sleeve to the sleeve Bu Xi. 优选地,套管包括由与护套及吊带主体连接的呈直管状的第一部分及呈子弹头状的第二部分。 Preferably, the sleeve comprises a first portion connected to the sheath body harness and a straight tubular shape and a second portion of the bullet-shaped. 更优选地,所述套管第一部分的长度为3mm~17mm,优选优选地,所述套管由具有高顺滑表面性质的聚全氟乙烯丙烯共聚物组成。 More preferably, the length of the first portion of the sleeve is 3mm ~ 17mm, preferably preferably, the sleeve comprises fluorinated ethylene propylene copolymer having a high surface smoothness properties of the composition. 采用上述形状和材料制备的套管, 能够减少穿刺过程中对组织及血管的损伤。 Preparation of the above-described shape and materials used in the casing can be reduced during the piercing and vascular tissue damage.

[0031] 为了更好地减少带有护套的吊带在人体内活动时与人体组织之间的阻力,优选所述护套具有光滑的表面,护套的材料优选为是聚乙烯或聚丙烯。 [0031] In order to reduce the resistance of the harness sheathed between human tissue, the sheath preferably has a smooth surface in the human body activity, the sheath material is preferably polyethylene or polypropylene.

[0032] 所述吊带主体的边缘设计弧形边缘,能少吊带边缘对组织的切割刺激,具有降低尿道及阴道侵蚀暴露几率的作用,同时,能够为吊带提供一定的固定力。 [0032] The arcuate edge design edge body harness, sling can be less stimulation tissue cutting edge, urethra and vagina with a reduced probability of corrosion exposure effect, while able to provide a certain fixing force harness. 特别对于纤维堆积增材制造技术制成的吊带主体,由于纤维堆积增材制造技术制成的吊带主体表面比较平整,不存在编织制成的吊带主体表面的毛刺或倒勾,因此纤维堆积增材制造技术制成的吊带主体与组织的固定力通常较低。 Sling especially for bulk body made of a fiber additive manufacturing technology, since the surface of the fiber sling body bulk additive manufacturing techniques made relatively flat, burrs or barbs of the strap body made of woven surface does not exist, the fiber material is deposited by manufacturing sling body tissue produced using the technique generally lower fixing force. 而将吊带主体边缘设计成弧形边缘,则可以提升纤维堆积增材制造技术制成的吊带主体的固定力。 The harness design curved edge to edge of the body, it can improve fixing force strap body made by bulk manufacturing techniques fiber material.

[0033] 优选地,所述弧形边缘由多个重复排列的弧形单元组成。 [0033] Preferably, the arcuate edges of the arcuate section composed of a plurality of repeatedly arranged. 进一步地,每个弧形单元的宽度为I mm〜I Omm,优选宽度为3〜7mm;相邻两个弧形单元的间距为为Omm〜I Omm,优选间距为3〜7mm〇 Further, the width of each element is arcuate I mm~I Omm, preferably a width of 3~7mm; two adjacent arcuate elements of pitch Omm~I Omm, preferably pitch 3~7mm〇

[0034] 所述吊带主体的机械性能要求可以参考现有吊带产品的机械性能,或参考正常女性阴道前壁的伸长率及尿失禁悬吊要求。 [0034] The mechanical properties of the body harness may be required mechanical properties of the conventional reference product of harness, a reference or normal female incontinence and elongation of the anterior vaginal wall suspension requirements. 优选地,所述吊带主体在承受2kg重力时的伸长率为10%〜50%,更优选为15%〜30%,更优选为20%〜25%。 Preferably, the sling body elongation when subjected to gravity 2kg 10% ~ 50%, more preferably 15% ~ 30%, more preferably 20% ~ 25%. 在此范围内,能提高吊带主体的自体化能力。 Within this range, can improve the ability of autologous sling body. 吊带主体的自体化能力是吊带修复效果的一个反映。 Since the main body of the ability to harness the restorative effects of a sling is reflected. 自体化能力越高,吊带主体更容易允许细胞、组织长入,与人体组织的粘附性强,生物相容性佳,吊带的材料及结构稳定,长期使用过程中无新释放出的材料和物质影响生物相容性,同时具有较好抗感染的能力。 Since the higher the capacity of the body, the body harness easier to allow the cells, tissue ingrowth, and human tissue strong adhesion, good biocompatibility, stability and structure of the sling material, no new long-term use and the release material biocompatible material impact, but also has a better ability to fight infection.

[0035] 所述吊带主体在承受2kg重力时的伸长率的测定方法是:将吊带主体裁剪为长度为50mm,宽I Imm的样条,采用万能拉力试验机进行测定,加载模式为定载荷模式,载荷数值设定为19.6N,然后用拉力试验机的夹具将吊带主体样条的两端夹住,拉力试验机调零后进行拉力测试,拉伸条件为:拉伸速度为50mm每分钟,夹具间距为40mm。 Method for measuring the elongation at the [0035] receiving said strap body is 2kg of gravity: the body harness cut into a length of 50mm, width I Imm spline, uses universal tensile testing machine was measured loading mode is given load mode, the value is set to 19.6N load, and clamp of the tensile tester with the both ends of the harness body sandwiched spline, a tensile test after tensile testing machine zero, stretching conditions as follows: tensile speed of 50mm per minute grip separation of 40mm. 记录吊带主体在19.6N 拉力时的拉伸伸长率。 Record body harness tensile elongation at a tensile force 19.6N.

[0036] 优选地,所述吊带主体的宽度为7〜15mm。 [0036] Preferably, the width of said strap body 7~15mm. 优选所述吊带主体的宽度为9mm〜11mm。 Preferably the width of said strap body is 9mm~11mm.

[0037] 制备本发明所述吊带主体的纤维膜层所用的材料,使用常规的不可降解材料制成。 [0037] Preparation of the fiber layer harness body of the present invention the materials used, made using a conventional non-degradable materials. 所述不可降解材料主要包括聚氟类材料(PVDF、PTFE等)、聚烯烃(聚乙烯、聚丙烯等)、聚氨酯类材料(PU、P⑶、TPU等)等不可降解材料。 The non-degradable materials include polyvinyl fluoride-based material (PVDF, PTFE, etc.), polyolefins (polyethylene, polypropylene, etc.), a polyurethane-based material (PU, P⑶, TPU and the like) and other non-degradable materials.

[0038] 更优选,将所述不可降解材料通过加工方法,制成具有一定蓬松度和稳定度的材料,如CN104645420A中所介绍的软组织修复补片,具备良好蓬松度,有利于细胞和组织的快速粘附和增殖、引导细胞分化,有利于组织之间的紧密贴合,同时其在长期的体内融合和演化过程中,保持孔隙尺寸和孔隙率的稳定。 [0038] More preferably, the non-degradable material by a processing method, made of a material having a certain degree of stability and bulkiness, soft tissue such as described in CN104645420A repair patch, have a good bulkiness, and is conducive to tissue cells rapid adhesion and proliferation, cell differentiation guide, facilitate close contact between the tissue, while its long-term evolution of the interbody fusion and to maintain stability of the pore size and porosity.

[0039] 优选地,所述纤维膜层为由直径在0.0ΐΜΐ~100μπι的纤维构成的纤维膜组织支架, 具有多孔状结构,其蓬松度为200~2000cm3/g,其纤维交接处发生融合形成纤维节点; [0039] Preferably, the diameter of the fiber layer by a tissue scaffold fibers 0.0ΐΜΐ ~ 100μπι fiber membrane composed of a porous structure having its bulkiness of 200 ~ 2000cm3 / g, the fiber fused to form a junction occurs fiber node;

[0040] 所述组织支架的稳定度S符合以下关系: [0040] The stability of the tissue stent S corresponding to the relationship:

Figure CN105250050BD00071

[0042] 其中T1为组织支架初始厚度,T2为力学疲劳试验后测得组织支架的厚度,厚度单位_1;3的数值为1~3〇 [0042] where T1 is the initial thickness of the tissue scaffold, T2 is the thickness measured after the tissue scaffold mechanical fatigue testing, the thickness of the unit _1; value is 1 to 3 3〇

[0043] 稳定度是指吊带主体材料的初始厚度与力学疲劳试验后测得吊带主体材料的厚度之比。 [0043] Stability is measured by means of the ratio of the thickness of the sling after the sling body material and mechanical fatigue test initial thickness of the host material. 所述组吊带主体的稳定度测试中,各参数的测试方式参考如下方法: The stability test set body harness, the test mode of the parameters refer to the following methods:

[0044] 所述吊带主体材料初始厚度的测试方法为利用FAST-I压缩性织物风格仪按照GB /T 7689.1-2001方法进行测试,表示吊带主体材料在2cN/cm2压强下厚度; [0044] The initial thickness of the test method for testing a material body harness according to GB / T 7689.1-2001 method, the host material represented by the thickness of the sling in 2cN / cm2 using a pressure of FAST-I compression fabric style instrument;

[0045] 所述力学疲劳试验为根据吊带主体材料,在IOMPa拉伸强度内,拉伸500000次。 The [0045] mechanical fatigue test according to harness host material within IOMPa tensile strength and 500,000 times.

[0046] 更优选地,所述纤维膜层为由直径在0.1μπι~10μπι的纤维构成的纤维膜组织支架。 [0046] More preferably, the fibrous layer fiber membrane by fiber diameter tissue scaffold composed 0.1μπι ~ 10μπι.

[0047] 所述纤维交接处发生融合形成纤维节点为在纤维间交叉搭接处发生融合形成的微观节点或在纤维间并排接触处发生融合形成的宏观节点。 [0047] The fibers forming the fiber fusion junction occurs as occurring microscopic node node formed by the fusion between the fibers or side by side at a macroscopic Intersection nodes occurring at the contact formed by the fusion between the fibers.

[0048] 优选地,所述微观节点的形状呈团状,平均直径为IOnm〜ΙΟμπι。 [0048] Preferably, the shape of the micro-nodes form of pellets, the average diameter of IOnm~ΙΟμπι.

[0049] 优选地,所述宏观节点呈线状、团状,线状宏观节点的线宽为25~1000μπι;团状宏观节点的平均直径为25〜ΙΟΟΟμπι。 [0049] Preferably, the macro node linearly slug, the macro node line width is 25 ~ 1000μπι; average diameter slug macro node is 25~ΙΟΟΟμπι.

[0050] 本发明中,所述的团状,包括表面规则的球形,或表面不规则的球形;该团状物是由于纤维融化后发生团聚形成的。 [0050] In the present invention, the slug, including regular spherical surface or spherical surface irregularities; regiment was melt agglomeration is due to fiber formation occurs.

[0051] 优选地,所述线状宏观节点的线宽为50~500μπι;团状宏观节点的直径为50~500μπι。 [0051] Preferably, the line width of the linear macro node 50 ~ 500μπι; macro node slug diameter of 50 ~ 500μπι.

[0052] 优选地,任意两个所述宏观节点的间距为100〜5000μπι。 [0052] Preferably, the pitch of any two of the macro node is 100~5000μπι. 更优选地,任意两个所述宏观节点的间距为1 〇〇〜I OOOym。 More preferably, the macrostructures of any two nodes spaced 1 〇〇~I OOOym.

[0053] 优选地,所述纤维膜层的蓬松度为200~2000 cm3/g。 [0053] Preferably, the bulkiness of the fiber layer is 200 ~ 2000 cm3 / g.

[0054] 优选地,所述纤维膜层的柔软度为50~500毫牛顿。 [0054] Preferably, the softness of the fiber layer is from 50 to 500 millinewtons.

[0055] 优选地,所述纤维膜层的柔软度为200~450毫牛顿。 [0055] Preferably, the softness of the fiber layer is 200 to 450 millinewtons.

[0056] 所述的蓬松度及柔软度可以参考CN103800096A,即本发明所述蓬松度是指由0.01 μπι~100μπι的纤维构成的组织支架的表观厚度与面密度之比的1000倍,即 [0056] The bulkiness and softness can refer CN103800096A, i.e., the present invention refers to the bulkiness of the tissue scaffold 1000 times greater than from 0.01 μπι ~ 100μπι fibers constituting the apparent thickness and surface density, i.e.,

[0057] 蓬松度=组织支架的表观厚度T3/面密度ω XlO3, [0057] bulkiness = apparent thickness of the tissue scaffold T3 / areal density ω XlO3,

[0058] 其中,蓬松度以cm3/g表示,表观厚度以mm表示,面密度以g/m2表示。 [0058] wherein bulkiness cm3 / g, said apparent thickness expressed in mm, the surface density is expressed in g / m2. 组织支架的表观厚度T3的测试方法是利用FAST-I压缩性织物风格仪按照GB/T 7689.1-2001方法进行测试,表示为组织支架在2cN/cm2压强下厚度(mm)与组织支架在lOOcN/cm2压强下厚度(mm)之差。 Test Method for Apparent thickness T3 is the use of a tissue scaffold FAST-I compression fabric style instrument tested in accordance with GB / T 7689.1-2001 method, expressed as a tissue scaffold at 2cN / cm2 pressure thickness (mm) tissue scaffold in lOOcN / cm2 pressure difference between the thickness (mm) of. 面密度ω的测试方式是在忽略组织支架的厚度的情况下,测定的单个面单位面积下的重量。 The areal density is the weight ω of the test mode in ignoring stent tissue thickness, measured per unit area of ​​a single face.

[0059] 所述的柔软度是指根据GB/T 8942-2002中方法测试出来的组织支架抗弯曲力和组织支架与缝隙处摩擦力的最大矢量之和,以毫牛顿表示,柔软度值越小说明膜越柔软。 Softness [0059] The means according to test out GB / T 8942-2002 in a tissue scaffold and tissue scaffold resistance to bending at the slot and the vector sum of the maximum frictional force, expressed in millinewtons, the softness value small description softer the film.

[0060] 上述所述吊带主体纤维膜的制备方法,可以参考CN103800096A、CN104645420A中记载的方法制备。 Preparation [0060] The method of the above-described body harness fiber membranes, reference may CN103800096A, CN104645420A preparation described.

[0061] 与现有技术相比,本发明具有如下有益效果: [0061] Compared with the prior art, the present invention has the following advantages:

[0062] 本发明所述的无张力悬吊带系统,通过对吊带主体和护套结构的设计,提高了吊带产品的自体化性能,通过在护套的一个面上设置孔,减少护套与人体组织的接触面积,从而显著减少带有护套的吊带的人体内活动时产生的阻力,大大提高了护套取出或对吊带进行牵引时的方便性和操作性。 [0062] sling tension-free system according to the present invention, the design of the harness body and the jacket structure, improves the performance of the sling autologous product through a hole provided in the surface of the sheath, the sheath and the body to reduce resistance generated when the contact area of ​​the tissue, thereby significantly reducing the body harness sheathed with activity, greatly improving the convenience and operability when a sheath or sling extraction traction. 所述吊带在植入人体的过程中,对人体组织的刺激小,长期植入后,能诱导自体细胞迅速沿吊带主体的纺丝纤维间的微孔生长,形成结缔组织并强化尿道周边组织,从而尿道周边组织恢复或接近正常的生理功能,本发明所述的无张力悬吊带系统能显著减少异物感及侵蚀、暴露、感染等并发症的发生。 The sling during implantation in the human body, a small stimulation of human tissue, after long-term implantation, the growth of the microporous body between the cells rapidly along the sling body can induce self-spun fiber, formed to strengthen the connective tissue and surrounding tissue urethra, periurethral tissue thereby restore or near normal physiological function, with a tension-free suspension system can significantly reduce the erosion and foreign body sensation to the present invention, exposure, infection and other complications.

附图说明 BRIEF DESCRIPTION

[0063] 图1为实施例1所述无张力悬吊带系统的一种结构示意图; [0063] FIG. 1 as a schematic structural diagram of the system with a tension-free suspension of the embodiment;

[0064] 图2为实施例1所述无张力悬吊带系统的一种结构示意图; [0064] FIG. 2 as a schematic structural diagram of the system with a tension-free suspension of the embodiment;

[0065] 图3为所述吊带主体上设置的通孔的结构示意图; [0065] FIG. 3 is a schematic view of the harness through hole provided on the body;

[0066] 图4为所述吊带主体边缘的结构示意图; [0066] FIG. 4 is a schematic view of an edge of the strap body;

[0067] 图5为所述套管的结构示意图。 [0067] FIG. 5 is a schematic view of the sleeve.

[0068] 图6为护套在被牵引或取出时的受力示意图。 [0068] FIG. 6 is a schematic view of the sheath stress when pulled or withdrawn.

具体实施方式 detailed description

[0069] 下面结合一些具体实施方式对本发明的无张力悬吊带系统做进一步描述。 [0069] below with reference to some specific embodiments of the belt tension-free suspension system of the present invention is further described. 具体实施例为进一步详细说明本发明,非限定本发明的保护范围。 Specific embodiments are described in further detail, the scope of the present invention is non-limiting of the present invention.

[0070] 实施例1 [0070] Example 1

[0071] 如图1显示了一种无张力悬吊带系统的实现形式,包括吊带主体1和包覆吊带主体表面的护套2和设于吊带主体两端的导引线4及用于保护导引线的套管3;所述吊带主体设置有由多个通孔11组成的镂空网格状结构,所述吊带主体为由纤维堆积增材制造技术制成的纤维层;所述通孔的边缘为弧边或直边,且当所述通孔的边缘为直边时,各直边之间圆滑过渡;所述吊带主体的边缘为弧形边缘;所述弧形边缘由多个重复排列的弧形单元12构成。 [0071] FIG 1 shows one form of tension to achieve no sling system, comprising a body harness and harness sheathing body 2 and the surface of the sling body provided at both ends of the guide wire 4 and for protecting the guide line of the sleeve 3; said strap body is provided with a hollow lattice-like structure consisting of a plurality of through-holes 11, the fiber sling body by stacking layers made of a fiber additive manufacturing techniques; edge of the through-hole an arc edge or a straight edge, and when the edge of the through hole is a straight edge, a smooth transition between the straight sides; said strap body edge is arcuate edges; said arcuate edges of a plurality of repeatedly arranged unit 12 is configured arcuate. 每个弧形重复单元的宽度为每个弧形重复单元的间距为〇_。 The arcuate width of each repeating unit pitch of each arcuate 〇_ repeating unit.

[0072] 所述护套2的上表面或下表面上设置有一个孔21,所述孔21的面积占其所在的护套上表面/下表面总面积的20%以上。 Is provided on the upper surface or the lower surface [0072] of the sheath 2 has a hole 21 or more, 20% of the total surface area / area of ​​the lower surface of the sheath of its hole 21 is located.

[0073] 图2显示了另一种无张力悬吊带系统的实现形式,包括吊带主体1和包覆吊带主体表面的护套2和设于吊带主体两端的导引线4及用于保护导引线的套管3;所述吊带主体设置有由多个通孔11组成的镂空网格状结构,所述吊带主体为由纤维堆积增材制造技术制成纤维层;所述通孔的边缘为弧边或直边,且当所述通孔的边缘为直边时,各直边之间圆滑过渡;所述吊带主体的边缘为弧形边缘;所述弧形边缘由多个重复排列的弧形单元12构成。 [0073] FIG. 2 shows another form of tension to achieve no sling system, comprising a body harness and harness sheathing body 2 and the surface of the sling body provided at both ends of the guide wire 4 and for protecting the guide line of the sleeve 3; said strap body is provided with a hollow lattice-like structure consisting of a plurality of through-holes 11, said strap body by stacking fibrous additive manufacturing technology is made of fibrous layer; edge of the through hole is arc edge or a straight edge, and when the edge of the through hole is a straight edge, a smooth transition between the straight sides; edge of the strap body is arcuate edges; repeating the arcuate edges by a plurality of arcs arranged shaped unit 12 is configured. 每个弧形重复单元的宽度为每个弧形重复单元的间距为〇_。 The arcuate width of each repeating unit pitch of each arcuate 〇_ repeating unit.

[0074] 所述护套2由对称分布的左护套22和右护套23组成,且左护套22和右护套23各自独立;所述左护套22和右护套23对应于吊带主体的同一面上分别设有孔221,231。 [0074] The sheath of the sheath 2 left and right symmetrical distribution 22 composed of sheath 23, the sheath 22 and the left and right jacket 23 is independently; sheath 22 of the left and right jacket 23 corresponding to the sling the same surface of the body is provided with holes 221, 231 respectively. 孔221, 231的面积占其所在的左护套上表面或右护套上表面面积的20%以上。 Hole 221, the sheath 231 left in the area of ​​its upper surface is located or the right 20% of the surface area of ​​the sheath above. 所述左护套22与右护套23在其相邻一端存在间隙,所述间隙的距离为O.lcm-lOcm。 The sheath 22 left and right sheath 23 adjacent one end thereof there is a gap, the gap distance is O.lcm-lOcm. 吊带主体1的宽度为7〜15mm〇 The width of the strap body 1 is 7~15mm〇

[0075] 图3展示了设于吊带主体上的通孔11的几种不同的形状,可以是椭圆形,圆形或四角圆滑过渡的方形。 [0075] Figure 3 shows several different through holes provided in the sling body 11 shape may be oval, round or square corners rounded transition.

[0076] 吊带主体1的弧形边缘12设计,如上所述可以是由多个重复排列的弧形单元12构成。 [0076] 1 strap body edge 12 of the arcuate design of the arcuate unit as described above may be a plurality of repeatedly arranged 12. 每个弧形重复单元的宽度为每个弧形重复单元的间距为Omm;或者如图4所示,每个弧形重复单元的存在小于IOmm的间距。 The arcuate width of each repeating unit is a repeating unit pitch of each of the arcuate Omm; or 4, the presence of each repeating unit is less than the arcuate distance IOmm.

[0077] 套管3的一端与吊带主体1连接,另一端呈锥体形。 [0077] One end of the sleeve body 3 and a harness connected to the other end of the conical shape. 优选地,所述套管3的形状如图5 所示,套管3包括由与吊带主体1连接的呈直管状的第一部分31及呈子弹头状的第二部分3 2。 Preferably, the shape of the sleeve 3 is shown in Figure 5, the sleeve 3 includes a body harness and connected to a straight tubular shape and a first portion 31 of the bullet-shaped second portion 32. 所述套管3的总长为5mm-20mm,优选I Omm-16mm;所述第一部分31的长度为3mm〜17mm,优选6mm〜13mm ;第一部分31的直径为2mm〜8mm,优选3mm〜5mm。 The total length of the sleeve 3 is 5mm-20mm, preferably I Omm-16mm; length of the first portion 31 is 3mm~17mm, preferably 6mm~13mm; diameter of the first portion 31 is 2mm~8mm, preferably 3mm~5mm.

[0078] 本实施例中,所述吊带主体为由直径在0.01μΐΉ~1 ΟΟμίΉ的静电纺丝纤维制成的组织支架,所用的材料可以是聚氟类材料(PVDF、PTFE等)、聚烯烃(聚乙烯、聚丙烯等)、聚氨酯类材料(PU、PCU、TPU等)等不可降解材料。 [0078] In this embodiment, the harness main body by tissue in the stent diameter 0.01μΐΉ ~ 1 ΟΟμίΉ electrostatic spun fibers made of the material used may be a polyvinyl fluoride-based material (PVDF, PTFE, etc.), polyolefin (polyethylene, polypropylene, etc.), a polyurethane-based material (PU, PCU, TPU and the like) and other non-degradable materials. 其蓬松度、稳定度不需要作额外的限制。 Its bulkiness, stability is no need for additional restrictions.

[0079] 为了更便于医生进行手术操作,优选地,所述护套上设置有定位线。 [0079] In order to facilitate the surgical procedure doctors, preferably provided with a bit line on the sheath. 优选地,所述定位线与护套在轴向上的对称线重合。 Preferably, the positioning wire sheath coincides with the axial line of symmetry. 对于图1的结构,由于护套2是一体成型,优选在定位线处设置撕裂线/裁剪线。 For the structure of Figure 1, since the sheath 2 is formed integrally, the tear line is preferably provided / trim line is positioned in line.

[0080] 实施例2 [0080] Example 2

[0081] 本实施例所述无张力悬吊带系统结构与实施例1的图1或图2所述结构相同。 [0081] The present embodiment with the tension-free suspension system configuration diagram of an embodiment of FIG. 1 or 2 of the same configuration.

[0082] 其中,所述吊带主体为由直径在0.01μπι~100μπι的纤维构成的组织支架,具有多孔状结构,其蓬松度为200~2000Cm3/g,其纤维交接处发生融合形成纤维节点; [0082] wherein said strap body by tissue scaffold fiber diameter 0.01μπι ~ 100μπι composed of porous structure having its bulkiness of 200 ~ 2000Cm3 / g, which fiber fusion junction occurs to form a fiber node;

[0083] 所述组织支架的稳定度S符合以下关系: [0083] The stability of the tissue stent S corresponding to the relationship:

Figure CN105250050BD00101

[0085] 其中T1为组织支架初始厚度,T2为力学疲劳试验后测得组织支架的厚度,厚度单位111111;3的数值为1~3。 [0085] where T1 is the initial thickness of the tissue scaffold, T2 is the thickness measured after the tissue scaffold mechanical fatigue testing, the thickness of the unit 111111; 3 value of 1 to 3. 本实施例中所述的吊带主体可以参考0附0464542(^中记载的制备方法制备。 Said harness body of the present embodiment may be embodiments with reference to attached 0464542 0 (^ prepared as described in the claims.

[0086] 据信,具有上述性能的吊带主体的具有更好的力学性能和修复性能。 [0086] It is believed that the body harness having the above properties have better repair properties and mechanical properties.

[0087] 对比例1 [0087] Comparative Example 1

[0088] 本对比例的无张力悬吊带系统除护套上不设有孔(即护套的上下表面均为密闭整体)外,其余结构与实施例1的图1所述的结构相同。 [0088] This comparative tension-free except that no system is provided with a suspension hole (i.e., the upper and lower surfaces of the sheath are sealed integrally) on the outer sheath, the remaining structure of the same configuration as in FIG. 1 described in Example 1.

[0089] 阻力测试实验按照如下方法进行: [0089] The resistance test was carried out as follows:

[0090] 将包覆有护套的吊带主体从长25cm,厚度为8cm的瘦牛肉块中心穿过。 [0090] The main body covered with a sheath from the sling length 25cm, a thickness of lean beef passing through the center of 8cm. 在牛肉上放置重物,用于模拟手术过程吊带穿过人体时,肌肉及筋膜组织对吊带的压迫力。 Place heavy objects on beef, for simulating surgical procedures strap through the human body, muscles and fascia tissue compression force on the strap. 随后将吊带主体露出牛肉外的部分剪断,保持余下部分不动,缓慢牵引导引线将护套及多余的吊带主体部分抽出,读取指针式推拉力计上的力学数值,记录后按复位键归零,开始下一组测试。 Subsequently the exposed portion of the sling body outer beef cut, holding the rest of fixed, slowly pulling the sheath and the guide wire harness excess body portion out, read pointer value on the mechanical push force gauge recorded press the reset button zero, start the next set of tests.

[0091] 取出护套的阻力测试结果如表1所示 [0091] Remove the sheath resistance test results are shown in Table 1

[0092] 表1 [0092] TABLE 1

Figure CN105250050BD00102

[0094] 从上述对比可以看出,本发明所述的结构,能够减少取出护套时所用的力。 [0094] As can be seen from the above comparison, the structure of the present invention, the sheath can be removed to reduce the force used. 因此更便于操作。 Thus easier to operate.

[0095] 护套从人体组织中取出时的受力情况如图6所示。 [0095] When the force is removed from the sheath in the case of human tissue as shown in FIG. 由于吊带植入过程中通常会发生折叠,因此取出过程中需要克服护套与人体组织、护套与吊带主体的多重作用力。 Since the sling implantation procedure usually occurs folded, so the process need to remove the sheath and against the biasing force of multiple human tissue, the sheath and the body harness. 图6a展示以具有对比例1所述的护套的受力情况。 Figure 6a shows the forces to claim 1 having a pair of sheath ratio. 吊带在人体组织中处于折叠的状态,在C处裁断之后,取出护套时,每层护套与吊带主体的接触面都会产生摩擦力,此时,将护套往D方向抽离人体时,护套受吊带主体的摩擦力为阳=4yF压(式中,F摩为护套取出所受吊带主体的摩擦力,μ为摩擦系数,F压为吊带所受压力),图6b展示以具有图1所示结构的护套的受力情况,当护套的上表面或下表面开孔后,护套在植入过程中向设有开孔的一面折叠,此时取出护套时护套受到摩擦力为阳=2yFji。 Sling in human tissue in folded state after the cut C, when removing a sheath, the sheath will each contact surface of the sling body frictional force is generated at this time, the sheath body when pulled to the direction D, frictional force by a sheath of a male body harness = 4yF pressure (where, F friction suffered harness withdrawn friction body is sheathed, [mu] is the friction coefficient, F is the pressure of pressure on the harness), Figure 6b shows to have a subject to the forces of the sheath structure shown in FIG. 1, when the lower surface of the opening, the sheath or the sheath upper surface during implantation to the side opening is provided folded, then remove sheath sheath by friction as the sun = 2yFji. 可见,在护套的一个面上设置开孔后,护套的摩擦阻力显著减小。 Visible, after setting an opening of a surface of the sheath, the sheath is significantly reduced frictional resistance. 因此在护套的一个面上设有孔的设计能够消除吊带折叠内部的摩擦力,从而能够减少取出护套时所用的力。 Thus in one surface of the sheath is provided with holes designed to eliminate friction within a fold harness, thereby reducing the force used to remove the sheath.

[0096] 以上所述仅为本发明的实施例,并非因此限制本发明的专利范围,凡是利用本发明说明书内容所作的等效结构或等效流程变换,或直接或间接运用在其他相关的技术领域,均同理包括在本发明的专利保护范围内。 [0096] The foregoing is only embodiments of the present invention, not intended to limit the scope of the present invention, the present invention is usually made by using a description equivalent structures or equivalent process, or applied directly or indirectly to other related art art shall fall within the scope of protection of the present invention.

Claims (23)

  1. 1. 一种无张力悬吊带系统,其特征在于,所述无张力悬吊带系统包括吊带主体和包覆吊带主体表面的护套;所述吊带主体由纤维膜层构成,所述吊带主体为由多个通孔组成的镂空网格状支架结构;所述护套的上表面或下表面上设置有孔。 A sling tension-free system, wherein said system comprises a tension-free sling strap body and a sheath covering the body surface of the strap; the strap body composed of fibrous layers, said strap body by hollow lattice support structure composed of a plurality of through-holes; a hole provided on the upper surface or lower surface of the sheath.
  2. 2. 根据权利要求1所述无张力悬吊带系统,其特征在于,所述护套上的孔的总面积占其所在的护套上表面或下表面总面积的10%以上。 1 according to the tension-free sling system of claim wherein the total area of ​​the holes of the sheath on the sheath or of its lower surface is located more than 10% of the total area of ​​the surface.
  3. 3. 根据权利要求2所述无张力悬吊带系统,其特征在于,所述护套上的孔的总面积占其所在的护套上表面或下表面总面积的20%〜50%。 3. The belt 2 tension-free suspension system as claimed in claim, characterized in that the upper or lower surface of the sheath of the total area of ​​the holes is located on said sheath accounted for 20% ~ 50% of the total area of ​​the surface.
  4. 4. 根据权利要求1所述无张力悬吊带系统,其特征在于,所述护套包括对称分布在吊带主体左半部和右半部的第一护套和第二护套;所述第一护套和第二护套分别由吊带主体的两端向吊带主体的中央延伸,且第一护套和第二护套各自独立;所述第一护套和第二护套上的孔位于同一面。 1 according to the sling tension-free system of claim wherein said jacket comprises a body harness symmetrically left and right first sheath and the second sheath portion; the first sheath and the second sheath extending respectively from opposite ends of the central body strap sling body, and the first sheath and second sheath are each independently; said first sheath and second sheath holes located in the same surface.
  5. 5. 根据权利要求4所述无张力悬吊带系统,其特征在于,设于第一护套和/或第二护套上的孔的数量为1〜5个。 5. The belt 4 tension-free suspension system according to claim, characterized in that the number provided in the first sheath and / or holes in the second sheath is ~ 5 months.
  6. 6. 根据权利要求4所述无张力悬吊带系统,其特征在于,所述第一护套与第二护套在其相邻一端存在间隙,所述间隙的距离为〇. I cm〜10cm。 6. The belt 4 tension-free suspension system as claimed in claim, wherein said first sheath and the second sheath in the presence of an end thereof adjacent to the gap, the gap distance is square. I cm~10cm.
  7. 7. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述吊带主体的上表面及下表面的粗糙度均为0. Iym〜50μηι。 According to claim any one of claims 1 to 6, with a tension-free suspension system, wherein said strap body upper and lower surface roughness are 0. Iym~50μηι.
  8. 8. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述吊带主体上的通孔的形状为圆形、椭圆形或设有倒角的多边形。 According to claim any one of claims 1 to 6, with the tension-free suspension system, characterized in that the shape of the harness through hole in the body is a circular, oval or polygonal with chamfered.
  9. 9. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述吊带主体上的通孔的孔径为1.5~5_。 As claimed in any one of claims 1 to 6, with the tension-free suspension system, characterized in that the diameter of the through-hole of the strap on the body is 1.5 ~ 5_.
  10. 10. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述吊带主体上的通孔在吊带主体上的分布密度为1〜10个/cm2。 According to claim any one of claims 1 to 6, with a tension-free suspension system, wherein a distribution density of said strap body through holes in the sling body is 1~10 number / cm2.
  11. 11. 根据权利要求6所述无张力悬吊带系统,其特征在于,所述吊带主体的上表面及下表面的粗糙度均为〇. Iym〜50μπι,所述吊带主体上的通孔的形状为圆形、椭圆形或设有倒角的多边形,所述吊带主体上的通孔的孔径为1.5〜5mm,所述吊带主体上的通孔在吊带主体上的分布密度为1〜10个/cm2。 11. The belt 6 tension-free suspension system as claimed in claim, characterized in that the roughness of the upper and lower surfaces of the sling body are square. Iym~50μπι, the through holes on said strap body is circular, elliptical, polygonal or provided with a chamfer, the diameter of the through holes on said strap body is 1.5~5mm, distribution density of the through holes on said strap body in the harness body is 1~10 / cm2 or .
  12. 12. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述吊带主体的厚度为〇· Imm〜lmm〇 According to claim any one of claims 1 to 6, with a tension-free suspension system, wherein a thickness of said strap body is square-Imm~lmm〇
  13. 13. 根据权利要求1至6任意一项所述无张力悬吊带系统,所述护套上设置有定位线。 As claimed in any one of claims 1 to 6, with the tension-free suspension system is provided with a bit line on the sheath.
  14. 14. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述无张力悬吊带系统的两端设有导引线和套管。 According to claim any one of claims 1 to 6, with a tension-free suspension system, characterized in that the free ends of the tension belt system is provided with suspension guidewire and sleeve.
  15. 15. 根据权利要求14所述无张力悬吊带系统,其特征在于,所述套管的一端与护套及吊带主体连接,另一端呈锥体形;所述导引线的一端与护套及吊带主体连接,另一端穿过套管的锥体形端部的开口延伸至套管外。 15. The suspension belt 14 tension-free system according to claim, characterized in that one end of the sleeve and the sheath body harness, and the other end of the conical shape; end of the sheath and guide wire harness connector body, the opening end of the cone-shaped portion and the other end extending through the sleeve to the outer sleeve.
  16. 16. 根据权利要求14所述的无张力悬吊带系统,所述套管的一端与护套和吊带主体连接,另一端呈子弹头形状;所述导引线的一端与护套及吊带主体连接,另一端穿过套管的子弹头形状端部的开口延伸至套管外。 16. A tension-free sling system as recited in claim 14, one end of the sleeve sheath and sling body, and the other end of the bullet shaped form; end of the sheath and guide wire harness connection body opening bullet shaped end portion and the other end extending through the sleeve to the outer sleeve.
  17. 17. 根据权利要求1至6任意一项所述的无张力悬吊带系统,所述吊带主体的边缘为弧形边缘,所述弧形边缘由多个重复排列的弧形单元组成;每个弧形单元的弧边的宽度为Imm 〜10mm,相邻两个弧形单元的间距为Omm〜10mm。 According to claim any one of claims 1 to 6, tension-free sling system, said strap body edge arcuate edge, said arcuate edges of the arcuate section of a plurality of repeatedly arranged; each arc the width of the arc-shaped side unit is Imm ~10mm, two adjacent arcuate units pitch Omm~10mm.
  18. 18. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述吊带主体在承受2kg重力时的伸长率为10%〜50%。 According to claim any one of claims 1 to 6, with a tension-free suspension system, wherein the body harness elongation at 2kg subjected gravity 10% ~ 50%.
  19. 19. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述吊带主体的宽度为7~15mm。 19. claimed in claim any one of claims 1 to 6, with a tension-free suspension system, wherein a width of said strap body 7 ~ 15mm.
  20. 20. 根据权利要求14所述无张力悬吊带系统,其特征在于,所述吊带主体的边缘为弧形边缘,所述弧形边缘由多个重复排列的弧形单元组成;每个弧形单元的弧边的宽度为lmm~ 10mm,相邻两个弧形单元的间距为Omm〜10mm;所述吊带主体在承受2kg重力时的伸长率为10%-50%〇 20. The suspension belt 14 tension-free system as claimed in claim, wherein an edge of the strap body is arcuate edges, the arcuate edges of the arcuate section of a plurality of repeatedly arranged; each arcuate section the width of the arc edge of lmm ~ 10mm, two adjacent arcuate units pitch Omm~10mm; elongation when subjected to the body harness 10% -50% 2kg gravity billion
  21. 21. 根据权利要求1至6任意一项所述无张力悬吊带系统,其特征在于,所述纤维膜层为由直径在0.01μπι~100μπι的纤维构成的纤维膜组织支架,具有多孔状结构,其蓬松度为200~ 2000cm3/g,其纤维交接处发生融合形成纤维节点; 所述组织支架的稳定度S符合以下关系: 21. A according to claim any one of claims 1 to 6, with a tension-free suspension system, characterized in that the fiber layer by the tissue scaffold fiber diameter 0.01μπι ~ 100μπι film fibers made of, having a porous structure, its bulkiness of 200 ~ 2000cm3 / g, the fiber forming a fiber node fusion junction occurs; S stability of the tissue scaffold corresponding to the relationship:
    Figure CN105250050BC00031
    其中T1为组织支架初始厚度,T2为力学疲劳试验后测得组织支架的厚度,厚度单位mm;S 的数值为1~3。 Wherein the tissue scaffold is the initial thickness T1, T2 of the measured thickness of the tissue scaffold after mechanical fatigue testing, thickness in mm; value S is 1 to 3.
  22. 22. 根据权利要求21所述无张力悬吊带系统,其特征在于,所述纤维膜层为由直径在 22. The suspension belt 21 tension-free system as claimed in claim, wherein the diameter of the fiber layer by
  23. 0.1μπι~10μπι的纤维构成的纤维膜组织支架。 Fibrous tissue scaffold fiber membrane composed 0.1μπι ~ 10μπι.
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