WO2019169901A1 - 一种用于加强肌腱吻合口的肌腱防粘连膜 - Google Patents

一种用于加强肌腱吻合口的肌腱防粘连膜 Download PDF

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WO2019169901A1
WO2019169901A1 PCT/CN2018/116449 CN2018116449W WO2019169901A1 WO 2019169901 A1 WO2019169901 A1 WO 2019169901A1 CN 2018116449 W CN2018116449 W CN 2018116449W WO 2019169901 A1 WO2019169901 A1 WO 2019169901A1
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tendon
barbs
membrane
adhesion
anchor
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王志勇
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王志勇
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1146—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of tendons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/0084—Material properties low friction
    • A61B2017/00849—Material properties low friction with respect to tissue, e.g. hollow organs
    • 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
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132—End-to-end connections

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  • the invention relates to a medical material for surgery, in particular to a tendon anti-adhesion film for strengthening an anastomosis of a tendon.
  • Tendon rupture is a common clinical trauma.
  • the common techniques of clinical repair of tendon rupture injury at home and abroad are mainly sutured by various suturing methods. After suturing, the external fixation is performed for 3 ⁇ 4 weeks.
  • the postoperative problems are as follows: First, the anastomosis is in a pulling state, which is unfavorable for tendon healing. After surgery, it usually takes 3 to 4 weeks to move. Secondly, tendon adhesion is prone to occur. Most patients have to perform tendon release surgery to bring secondary trauma to the patient.
  • Tendon healing has both endogenous healing and exogenous healing. In order to prevent the formation of tendon adhesion, it should promote endogenous healing and inhibit exogenous healing.
  • the method for relieving the exogenous healing of tendon is mainly to use the mechanical barrier of the biological or non-biological material to make an anastomosis, and to perform moderate functional exercise early in the postoperative period.
  • excessive exercise after surgery tends to cause the tendon to break again or the broken end to be separated and requires surgery.
  • Invention patent 201210246728.3 (Chen Xiaoming, material for making tendon anastomat, tendon stapler using the same, and manufacturing method thereof, 2012.07.17) discloses a material for making a tendon anastomat, a tendon anastomat using the same and Production method.
  • the material is composed of 69-90% polylactic acid, 8-30% polycaprolactone, 0.5-2% silicone oil by mass percentage, and is prepared by melt blending modification technology, which can be used for flexibility with high strength. Anti-adhesion membrane and used in clinical practice.
  • invention patent 200910063739.6 (Li Jin, central tendon anastomat, 2005.8) and invention patent 200920227679.2 (Li Jin, central tendon anastomat, 2005.8) disclosed a body a central tendon anastomat consisting of two sutures and two suture needles, the body is made of a strip-shaped structure made of biodegradable biomaterial, the middle part is an elliptical cylinder, the ends are elliptical cones, and two sutures One end is connected to the body, and the other ends of the two sutures are respectively connected to the tails of the two suture needles.
  • the invention creatively uses the biological material to improve the quality and strength of the tendon anastomosis, can start the movement after 2 days of surgery, reduces the probability of tendon adhesion, and reduces the second operation.
  • the above-mentioned invention is inconvenient in that the surgical procedure is relatively complicated, the operation difficulty is relatively large, the fixation effect is unreliable, and the risk of tendon adhesion at the tendon suture is still large.
  • Invention invention patent 201520264694.X (Yang Fanwen, a novel tendon anastomat, 2015.04.28) discloses a method for using an anti-adhesion membrane for strengthening an anastomosis of a tendon, and the anti-adhesion membrane is made into a rectangular mesh belt body, the surface A plurality of through holes are evenly opened, and the tendons are anastomosed through the through holes when suturing.
  • the invention overcomes the shortcomings in the prior art that the direct suturing technique is easy to pull open, but the pulling force is still concentrated on the anastomosis mouth, the level of the tensile strength is limited, and the functional exercise is not suitable immediately after the operation.
  • Invention patent 201210246728.3 (Chen Xiaoming, material for making tendon anastomat, tendon stapler using the material and manufacturing method, 2012.07.17) also discloses a tendon anastomat, which is connected to the broken tendon during the tendon repair operation.
  • the stapler is wrapped at the interface of the broken tendon, and the tendon repair operation can be completed by locking the tendon with a self-locking mechanism.
  • the invention creatively uses the tendon anti-adhesion membrane to fix the tendon, reduce the tensile stress of the tendon fracture, and can immediately exercise after the operation, which can effectively reduce the risk of tendon adhesion.
  • Invention patent 201320008240.7 (Yang Fanwen, a bioabsorbent tendon anastomat with self-locking mechanism, 2013.01.08) put the ratchet of the prior patent on both sides, improving the patient's feeling of surrounding muscle discomfort and postoperative site
  • Both inventions directly use the anchor to compress the fixed tendon.
  • the ratchet can only be locked in one direction and cannot be adjusted, so it has an oppressive effect on the tendon, which is not conducive to the endogenous healing of the tendon.
  • the bayonet may affect the movement of the tendon, and the tensile strength of the anchor compression is not very reliable, and its application in clinical practice is still limited.
  • the object of the present invention is to provide a simple structure and convenient use, which can meet the normal activity requirements of tendon rupture after surgery, reduce the tension of the tendon anastomosis, and can immediately perform functional exercise after surgery, reduce the risk of tendon adhesion and improve the clinical operation effect. To avoid the tendon anti-adhesion membrane of the second operation.
  • a tendon anti-adhesion membrane for strengthening an anastomosis of a tendon comprising: a membrane body and an anchor, the membrane is a narrow strip of biomaterial film, and the membrane is uniformly distributed.
  • the membrane body is divided into a guiding section and a bonding section along the length thereof, and a plurality of anchor nails are arranged on the inner side surface of the bonding section, the barbs are provided with barbs, and the anchors are barbed
  • the positions of the barbs on the anchors of different positions or misalignments are the same, the overall structure of the anchors and barbs is made of biological materials, and the above biomaterials are polylactic acid biomaterials.
  • the anchor and barb integral structure is made of a titanium alloy.
  • micropores are 0.01-0.05 mm.
  • the invention adopts a narrow strip membrane structure made of biodegradable biomaterial, has strong strength and flexibility, can effectively ensure the limited operation space placement in the operation, and smooth the tension, ensures sufficient package and improves the anastomosis effect;
  • the initial section of the membrane body is a guiding section without anchors, the rear end is an anchor with a barb, the anchor is provided with a certain number of barbs, and the anchor and barb structure are made of degradable biomaterial. It is fused with human tissue, or titanium alloy, which has little reaction with human tissue, which effectively improves the safety of use and does not require secondary surgery.
  • the anchor is inserted into the tendon and firmly anchored by the barb so that the tendon anti-adhesive membrane is firmly fixed on the tendon without the need of external pressure fixation.
  • the membrane is guided around the circumference of the tendon by the guiding segment to force the tendon after suturing.
  • the point evenly divides the surface into a certain area around the anastomosis mouth, which overcomes the shortcomings of the existing stapler which requires the addition of a locking device, the compression of the tendon and the healing of the tendon.
  • the anchors are staggered to make the force points more uniform.
  • the tendon anti-adhesion membrane provided by the invention does not affect the endogenous and exogenous healing of the tendon, does not form a compression on the tendon, and provides sufficient tensile force during the healing period of the tendon, so that the tendon repair can immediately begin the rehabilitation activity without the need for Brake, thus avoiding adhesion between tendons and tissues around the tendons, greatly improving the quality and strength of tendon anastomosis, reducing secondary surgery, and improving medical safety and effectiveness.
  • Figure 1 is a schematic structural view of the present invention
  • Figure 2 is a diagram showing the state of use of the present invention.
  • the film body 1 the guiding section 2, the bonding section 3, the anchor nail 4, and the barb 5.
  • a tendon anti-adhesion membrane for strengthening the anastomosis of the tendon including the membrane body 1 and the anchor 4, the membrane is a narrow strip of biomaterial membrane, and the membrane body is uniformly covered with a plurality of micropores.
  • the micropores are 0.01-0.05 mm, and the membrane body is divided into a guiding section 2 and a bonding section 3 along the length thereof, and a plurality of anchors 4 are arranged on the inner side of the bonding section 3, and the anchor nails are provided with barbs 5.
  • the position of the barbs on the adjacent anchors is different or the position of the barbs on the misaligned anchors is the same.
  • the overall structure of the anchors and barbs is made of biological materials, and the above biological materials are polylactic acid biomaterials.
  • the anchor and the barb integral structure may also be made of a titanium alloy.

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Abstract

一种用于加强肌腱吻合口的肌腱防粘连膜，包括膜体（1）和锚钉（4），膜体（1）为窄条状生物材料膜，膜体（1）上均布有多个微孔，膜体（1）沿其长度方向分为引导段（2）和粘合段（3），粘合段（3）内侧面上均布设有多个锚钉（4），锚钉（4）上带有倒钩（5），相邻锚钉（4）上倒钩（5）位置不同或错位锚钉（4）上倒钩（5）位置相同，锚钉（4）和倒钩（5）整体结构采用生物材料，生物材料为聚乳酸生物材料。其结构简单、使用便捷，能满足肌腱断裂手术后肌腱正常活动需求，减轻肌腱吻合口的张力，手术后可病人可立即功能锻炼，降低肌腱粘连风险，提高临床手术效果，避免二次手术。

Description

一种用于加强肌腱吻合口的肌腱防粘连膜 技术领域
本发明涉及一种外科用医用材料，具体说是一种用于加强肌腱吻合口的肌腱防粘连膜。
背景技术
肌腱断裂是临床常见外伤。目前，国内外肌腱断裂损伤临床修复手术常用技术主要各种缝合方法直接缝合，缝合后外固定3‐4周，术后存在的问题有：一是吻合口处于牵拉状态，对肌腱愈合不利，手术后一般须固定3‐4周后才能活动；二是易出现肌腱粘连，多数患者不得不实施肌腱松解手术，给患者带来二次创伤。
针对上述采用手术线缝合修复肌腱损伤的不足，现通常的方法是用可吸收材料制作的防粘连膜将肌腱包裹，防止出现肌腱粘连。但术后仍需固定3‐4周，效果也不尽人意。也有学者认为防粘连膜用于二次肌腱松解手术时效果较为理想。
肌腱损伤术后导致粘连一直是手外科领域的一个难题。肌腱愈合既存在内源性愈合，又存在外源性愈合。为防止肌腱粘连的形成，应促进内源性愈合，抑制外源性愈合。减轻肌腱外源性愈合的方法主要是利用生物或非生物材料机械屏障吻合口，术后早期进行适度的功能锻炼。然而，由于现有的肌腱修复技术在缝合部位张力不够，术后过多的锻炼容易导致肌腱再次断裂或断端分离而需再次手术。
已有大量的研究证明生物材料用于防肌腱粘连的安全性，但主要用于将肌腱与周围组织分隔，未涉及提高吻合口的抗拉力。从肖森等人(肖森等.聚已内酯增韧聚乳酸共混材料的制备与性能研究.塑料丁业，2010,38(6):15‐18)的研究结果可知，可以使用共混材料的制备具用一定强度和韧性的生物材料。发明专利201210246728.3(陈晓明，制作肌腱吻合器的材料、使用该材料的肌腱吻合器及制作方法，2012.07.17)公开了一种用于制作肌腱吻合器的材料、使用该材料的肌腱吻合器及其制造方法。该材料按质量百分比，由69‐90％聚乳酸、8‐30％聚己内酯、0.5‐2％硅油组成，采用熔融共混改性技术制备，可制出用于具有较高强度的柔性防粘连膜并用于临床。
针对肌腱缝合手术后容易引发肌腱粘连的问题，发明专利200910063739.6(李进，中心式肌腱吻合器，2009.8)和发明专利200920227679.2(李进，中心式肌腱吻合器，2009.8)公开了一种由体部、两条缝合线和两根缝合针构成的中心式肌腱吻合器，体部由可降解生物材料制成的长条状结构，中段为椭圆柱体形，两端为椭圆锥体形，两条缝合线的一端分别与体部相连，两条缝合线的另一端分别与两根缝合针的尾部相连。该发明创造性地将生物材料用于提高了肌腱吻合质量与强度，手术2天后可开始运动，降低了肌腱粘连概率，减少二次手术。上述发明不足之处在于手术过程比较复杂，操作难度也比较大，固定效果不可靠，肌腱缝合处发生肌腱粘连的风险仍较大。
发明发明专利201520264694.X(阳范文，一种新型肌腱吻合器，2015.04.28)公开了一种将防粘连膜用于加强肌腱吻合口的方法，将防粘连膜制成矩形网带本体，表面均匀开设有若干通孔，缝合时通过通孔吻合肌腱。本发明克服了现有技术中直接缝合技术容易拉豁的不足，但拉力仍集中于吻合口，增加抗拉力水平有限，术后仍不宜立即功能锻炼。
发明专利201210246728.3(陈晓明，制作肌腱吻合器的材料、使用该材料的肌腱吻合器及制作方法，2012.07.17)同时还公开了一种肌腱吻合器，实施肌腱修复手术时将断裂的肌腱对接好，将吻合器包裹在断裂肌腱的接口处，利用自锁机构将肌腱锁紧就可完成肌腱修复手术。该发明创造性地将肌腱防粘连膜用于固定肌腱、降低肌腱断口张应力，手术后可立即锻炼，可有效降低肌腱粘连风险。发明专利201320008240.7(阳范文，一种具有自锁机构的生物吸收肌腱吻合器，2013.01.08)将前专利的棘齿改置于两侧，改善了术后初期患者感觉周围肌肉不适及术后患处欠美观的缺点。但二种发明均直接使用锚钉压迫固定肌腱，棘齿只能单向锁定，不可调整，因此对肌腱有压迫作用，不利于肌腱的内源性愈合。同时卡口可能 影响肌腱的运动，锚钉压迫所产生的抗拉力能力亦不十分可靠，在临床上应用仍有限。
因此，为了提高肌腱吻合手术效果，需要研究一种能更有效防止手术后肌腱粘连、可增强吻合口抗拉力能力的材料，同时需要设计一种能将该材料平整包裹肌腱、可操作性强的装置，彻底解决肌腱粘连的问题。
发明内容
本发明的目的是提供一种结构简单、使用便捷，能满足肌腱断裂手术后肌腱正常活动需求，减轻肌腱吻合口的张力，手术后可病人可立即功能锻炼，降低肌腱粘连风险，提高临床手术效果，避免二次手术的肌腱防粘连膜。
本发明的目的是通过以下方案实现：一种用于加强肌腱吻合口的肌腱防粘连膜，其特征在于：包括膜体和锚钉，膜体为窄条状生物材料膜，膜体上均布有多个微孔，膜体沿其长度方向分为引导段和粘合段，粘合段内侧面上均布设有多个锚钉，锚钉上带有倒钩，相邻锚钉上倒钩位置不同或错位锚钉上倒钩位置相同，锚钉和倒钩整体结构采用生物材料，上述生物材料为聚乳酸生物材料。
所述锚钉和倒钩整体结构采用钛合金。
任一锚钉圆周设有两只以上倒钩，相邻锚钉上倒钩位置不同，或同一锚钉上倒钩朝向不同。
所述微孔为0.01‐0.05mm。
本发明采用可降解的生物材料制成的窄条膜体结构，有较强的强度和柔性，能有效确保手术中有限操作空间放置，以及平整张力，确保包裹充分，提高吻合效果；膜体带有微孔，微孔大小0.01‐0.1mm，不降低防粘连膜抗张力的强度。膜体的起始段为不带锚钉的引导段，后端为布有带倒勾的锚钉，锚钉上加一定数量的倒勾，锚钉和倒钩结构用可降解生物材料制成，与人体组织融合生长，或是钛合金，与人体组织反应小，有效提高使用安全性能，且无需二次手术取出。锚钉插入肌腱，通过倒钩牢固锚接使肌腱防粘连膜膜体牢牢地固定在肌腱上，不需要外加压力固定，膜体经引导段引导绕肌腱圆周绕卷使缝合后肌腱的受力点均匀分面于吻合口周围一定区域内，克服了现有吻合器需外加锁定装置、对肌腱产生压迫、影响肌腱愈合的缺点。锚钉错开排列，可以使受力点更为均匀。
本发明提供的肌腱防粘连膜，不影响肌腱的内源和外源愈合，不对肌腱形成压迫，在肌腱愈合期始终提供足够的抗拉力，使肌腱修复术后能够即刻开始康复活动而不需要制动，从而避免了肌腱和肌腱周围组织之间发生粘连，大幅提高肌腱吻合质量与强度，减少二次手术，提高医疗安全和效果。
附图说明
图1为本发明结构示意图；
图2为本发明使用状态图。
图中：膜体1、引导段2、粘合段3、锚钉4、倒钩5。
具体实施方式
以下结合附图和实施例作进一步说明。
图1、2所示：一种用于加强肌腱吻合口的肌腱防粘连膜，包括膜体1和锚钉4，膜体为窄条状生物材料膜，膜体上均布有多个微孔，微孔为0.01‐0.05mm，膜体沿其长度方向分为引导段2和粘合段3，粘合段3内侧面上均布设有多个锚钉4，锚钉4上带有倒钩5，相邻锚钉上倒钩位置不同或错位锚钉上倒钩位置相同，锚钉和倒钩整体结构采用生物材料，上述生物材料为聚乳酸生物材料。
在上述实施例基础上，锚钉和倒钩整体结构还可采用钛合金。
在上述实施例基础上，任一锚钉圆周设有两只以上倒钩，相邻锚钉上倒钩位置不同，或同一锚钉上倒钩朝向不同。

Claims (4)

  1. 一种用于加强肌腱吻合口的肌腱防粘连膜，其特征在于：包括膜体和锚钉，膜体为窄条状生物材料膜，膜体上均布有多个微孔，膜体沿其长度方向分为引导段和粘合段，粘合段内侧面上均布设有多个锚钉，锚钉上带有倒钩，相邻锚钉上倒钩位置不同或错位锚钉上倒钩位置相同，锚钉和倒钩整体结构采用生物材料，上述生物材料为聚乳酸生物材料。
  2. 根据权利要求1所述的一种用于加强肌腱吻合口的肌腱防粘连膜，其特征在于：所述锚钉和倒钩整体结构采用钛合金。
  3. 根据权利要求1所述的一种用于加强肌腱吻合口的肌腱防粘连膜，其特征在于：任一锚钉圆周设有两只以上倒钩，相邻锚钉上倒钩位置不同，或同一锚钉上倒钩朝向不同。
  4. 根据权利要求1或4所述的一种用于加强肌腱吻合口的肌腱防粘连膜，其特征在于：所述微孔为0.01‐0.05mm。
PCT/CN2018/116449 2018-03-05 2018-11-20 一种用于加强肌腱吻合口的肌腱防粘连膜 WO2019169901A1 (zh)

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