CN106821542A - 用于成人腹股沟疝tape术式修补的支架性补片 - Google Patents

用于成人腹股沟疝tape术式修补的支架性补片 Download PDF

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CN106821542A
CN106821542A CN201710089188.5A CN201710089188A CN106821542A CN 106821542 A CN106821542 A CN 106821542A CN 201710089188 A CN201710089188 A CN 201710089188A CN 106821542 A CN106821542 A CN 106821542A
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周建平
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0008Rounded shapes, e.g. with rounded corners elliptical or oval
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
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Abstract

本发明公开了一种用于成人腹股沟疝TAPE术式修补的支架性补片,包括椭圆形的封堵网片,所述封堵网片内侧部的外侧面固定设有半椭圆形的内侧部支架,所述封堵网片外侧部的外侧面固定设有平面月牙形的外侧部支架,所述内侧部支架的外侧边与所述封堵网片的边缘重合,所述内侧部支架的内侧边为朝向所述外侧边拱起的圆弧边,所述外侧部支架的外弧边与所述封堵网片的边缘重合且外侧部支架下方的尖部去除。本发明具有机械固定牢固、术中操作性好、在体内长期机械稳定性好、不移位、不卷曲变形等优点。

Description

用于成人腹股沟疝TAPE术式修补的支架性补片
技术领域
本发明涉及用于成人腹股沟疝修补的复合材料,尤其涉及一种用于成人腹股沟疝TAPE术式修补的支架性补片。
背景技术
成人腹股沟疝是人类的一种常见病,发生原因是由于封闭肌耻骨孔的腹横筋膜出现先天性缺陷或后天性退行性变导致该区域薄弱或缺损。目前,手术修补是治愈这种疾病的唯一有效方法,手术方法包括经前路的传统修补术、使用人工材料的无张力疝修补术和经后路的肌耻骨孔封堵术。无张力疝修补术以其复发率低、恢复快等优势逐步取代了传统的有张力疝修补术,成为了目前的主流手术方式。但经前路的无张力修补术尚存在以下问题:1.手术经路性损伤没有减少,术后恢复时间还是相对较长;2.人工材料容易导致并发症;3.术后存在慢性疼痛现象。
近年逐渐开展的后路修补TAPP术式及TEP术式减少了经路性损伤,但人工材料导致的并发症仍然存在,且技术要求较高,医生的学习曲线时间较长。从理论上讲,TAPE(transabdominal partial extraperitoneal)修补是最合理的手术方式,具有经路损伤小、手术操作简单、材料并发症少、符合人体解剖结构等优点,但目前尚缺乏一种针对TAPE术式修补的专用材料。
发明内容
本发明要解决的技术问题是克服现有技术的不足,提供一种机械固定牢固、术中操作性好、在体内长期机械稳定性好、不移位、不卷曲变形的用于成人腹股沟疝TAPE术式修补的支架性补片。
为解决上述技术问题,本发明采用以下技术方案:
一种用于成人腹股沟疝TAPE术式修补的支架性补片,包括椭圆形的封堵网片,所述封堵网片内侧部的外侧面固定设有半椭圆形的内侧部支架,所述封堵网片外侧部的外侧面固定设有平面月牙形的外侧部支架,所述内侧部支架的外侧边与所述封堵网片的边缘重合,所述内侧部支架的内侧边为朝向所述外侧边拱起的圆弧边,所述外侧部支架的外弧边与所述封堵网片的边缘重合且外侧部支架下方的尖部去除。
作为上述技术方案的进一步改进:
所述内侧部支架和所述外侧部支架上均开设有多个多边形网孔。
所述多边形网孔为正六边形网孔且对边距离为3mm-4mm。
所述封堵网片外侧部的内侧面设有防粘边涂层,所述防粘边涂层布满所在的半椭圆区域。
所述内侧部支架和所述外侧部支架均采用车线缝制于所述封堵网片上。
所述内侧部支架和所述外侧部支架均为镍钛合金支架;所述封堵网片为聚丙烯网片。
所述防粘边涂层术后完全吸收的时间为85~95天。
所述内侧部支架的内侧边上下两端与外侧边之间均通过圆弧连接,所述外侧部支架的内弧边上端与外弧边上端通过圆弧连接,所述外侧部支架的内弧边下端与外弧边下端通过直线连接。
与现有技术相比,本发明的优点在于:本发明公开的用于成人腹股沟疝TAPE术式修补的支架性补片,利用封堵网片进行封堵,由于发生腹股沟疝的这个区域没有运动功能,同时肌耻骨孔是一个半肌半骨性边缘,这为采用支架性补片提供了可靠的固定区,在封堵网片上固定设置不同形状的内侧部支架和外侧部支架,内侧部支架的外侧边与封堵网片的边缘重合,内侧部支架的内侧边为朝向外侧边拱起的圆弧边,外侧部支架的外弧边与封堵网片的边缘重合且外侧部支架下方的尖部去除,可以保证补片机械固定牢靠,在体内长期机械稳定性好、不移位、不卷曲变形,避免了现有补片太软不易展平的缺陷,可以保证术中良好的手术操作性,放置补片方便快捷,且两个支架充分避开了患者手术区域的血管和神经等,临床试验表明本发明的补片可以达到手术损伤小、手术并发症少、病人康复快、医生学习曲线时间短的作用,最大程度地降低伤口感染、慢性疼痛等。
进一步地,在内侧部支架和外侧部支架上设置多个多边形网孔,使得两个支架可以保持与局部解剖结构良好的适应性,且组织长入后形成较少的疤痕,同时长期力学稳定性良好。
进一步地,在封堵网片外侧部的内侧面设置防粘边涂层,防粘边涂层术后完全吸收的时间为为3个月左右,在吸收过程中逐渐为腹膜长入的内皮细胞覆盖,可以减少对腹腔内脏的干扰。
附图说明
图1是右侧腹股沟斜疝进行TAPE术式修补置入补片时的状态。
图2是左侧腹股沟斜疝进行TAPE术式修补后补片固定后的状态。
图3是本发明用于成人腹股沟疝TAPE术式修补的支架性补片正面的结构示意图。
图4是本发明用于成人腹股沟疝TAPE术式修补的支架性补片背面的结构示意图。
图5是本发明中的封堵网片的结构示意图。
图中各标号表示:1、封堵网片;2、内侧部支架;21、外侧边;22、内侧边;3、外侧部支架;31、外弧边;32、内弧边;4、多边形网孔;5、防粘边涂层。
具体实施方式
以下将结合说明书附图和具体实施例对本发明做进一步详细说明。
如图3、图4和图5所示,本实施例的用于成人腹股沟疝TAPE术式修补的支架性补片,包括椭圆形的封堵网片1,封堵网片1内侧部的外侧面(图示中为长轴左端的正面)固定设有半椭圆形(沿椭圆短轴处分开所形成)的内侧部支架2,封堵网片1外侧部的外侧面(图示中为长轴右端的正面)固定设有平面月牙形的外侧部支架3,内侧部支架2的外侧边21与封堵网片1的边缘重合,内侧部支架2的内侧边22为朝向外侧边21拱起的圆弧边,外侧部支架3的外弧边31与封堵网片1的边缘重合且外侧部支架3下方的尖部去除。
该用于成人腹股沟疝TAPE术式修补的支架性补片,利用封堵网片1进行封堵,由于发生腹股沟疝的这个区域没有运动功能,同时肌耻骨孔是一个半肌半骨性边缘,这为采用支架性补片提供了可靠的固定区,在封堵网片1上固定设置不同形状的内侧部支架2和外侧部支架3,内侧部支架2的外侧边21与封堵网片1的边缘重合,内侧部支架2的内侧边22为朝向外侧边21拱起的圆弧边,外侧部支架3的外弧边31与封堵网片1的边缘重合且外侧部支架3下方的尖部去除,可以保证补片机械固定牢靠,在体内长期机械稳定性好、不移位、不卷曲变形,避免了现有补片太软不易展平的缺陷,可以保证术中良好的手术操作性,放置补片方便快捷,且两个支架充分避开了患者手术区域的血管和神经等,临床试验表明本发明的补片可以达到手术损伤小、手术并发症少、病人康复快、医生学习曲线时间短的作用,最大程度地降低伤口感染、慢性疼痛等。
内侧部支架2和外侧部支架3上均开设有多个多边形网孔4。本实施例中,多边形网孔4为正六边形网孔且对边距离为3mm-4mm(即内切圆直径为3mm-4mm),在支架上设置多边形网孔4,使得两个支架可以保持与局部解剖结构良好的适应性,且组织长入后形成较少的疤痕,同时长期力学稳定性良好。
本实施例中,封堵网片1外侧部的内侧面(图示中长轴右端的背面)设有防粘边涂层5,防粘边涂层5布满所在的半椭圆(沿椭圆短轴处分开所形成)区域,防粘边涂层5术后完全吸收的时间为90天左右,在吸收过程中逐渐为腹膜长入的内皮细胞覆盖,可以减少对腹腔内脏的干扰。
本实施例中,内侧部支架2和外侧部支架3均采用车线缝制于封堵网片1上,车线可采用连续式或多点(多段)断开式。
本实施例中,内侧部支架2和外侧部支架3均为镍钛合金支架,钛合金支架长期力学性能稳定,与组织相容性好;封堵网片1为聚丙烯网片,聚丙烯网片质量轻、机械性能稳定,与组织相容性好。
本实施例中,内侧部支架2的内侧边22上下两端与外侧边21之间均通过圆弧连接,外侧部支架3的内弧边32上端与外弧边31上端通过圆弧连接,可避免支架本身产生应力集中;外侧部支架3的内弧边32下端与外弧边31下端通过直线连接,便于裁剪。
本发明的用于成人腹股沟疝TAPE术式修补的支架性补片,其使用方法是:
S1在脐部上或下取一1cm长的横切口作为观察孔,切开皮肤达皮下,置入一直径10mm-12mm Trocar(套管针/套针),进入腹腔;平脐水平的腹直肌外侧缘,左、右侧分别置入5mm Trocar进入腹腔作为操作孔。
S2观察腹腔内情况,明确腹股沟疝的类型:斜疝于内环处作内荷包缝合,高位结扎疝囊;直疝或股疝分离出疝囊,分离出患侧耻骨膀胱间隙,显露耻骨梳韧带及耻骨结节,直疝的假疝囊予以回拖并固定于耻骨梳韧带或作间断缝合处理。
S3置入本发明的补片,于标志点用专用钉固定补片,相应的疼痛区和危险三角区采用可吸收缝合固定补片,采用缝合或用胶水将脐内侧韧带固定至补片上,完成手术。
虽然本发明已以较佳实施例揭露如上,然而并非用以限定本发明。任何熟悉本领域的技术人员,在不脱离本发明技术方案范围的情况下,都可利用上述揭示的技术内容对本发明技术方案做出许多可能的变动和修饰,或修改为等同变化的等效实施例。因此,凡是未脱离本发明技术方案的内容,依据本发明技术实质对以上实施例所做的任何简单修改、等同变化及修饰,均应落在本发明技术方案保护的范围内。

Claims (8)

1.一种用于成人腹股沟疝TAPE术式修补的支架性补片,其特征在于:包括椭圆形的封堵网片(1),所述封堵网片(1)内侧部的外侧面固定设有半椭圆形的内侧部支架(2),所述封堵网片(1)外侧部的外侧面固定设有平面月牙形的外侧部支架(3),所述内侧部支架(2)的外侧边(21)与所述封堵网片(1)的边缘重合,所述内侧部支架(2)的内侧边(22)为朝向所述外侧边(21)拱起的圆弧边,所述外侧部支架(3)的外弧边(31)与所述封堵网片(1)的边缘重合且外侧部支架(3)下方的尖部去除。
2.根据权利要求1所述的用于成人腹股沟疝TAPE术式修补的支架性补片,其特征在于:所述内侧部支架(2)和所述外侧部支架(3)上均开设有多个多边形网孔(4)。
3.根据权利要求2所述的用于成人腹股沟疝TAPE术式修补的支架性补片,其特征在于:所述多边形网孔(4)为正六边形网孔且对边距离为3mm-4mm。
4.根据权利要求1或2或3所述的用于成人腹股沟疝TAPE术式修补的支架性补片,其特征在于:所述封堵网片(1)外侧部的内侧面设有防粘边涂层(5),所述防粘边涂层(5)布满所在的半椭圆区域。
5.根据权利要求4所述的用于成人腹股沟疝TAPE术式修补的支架性补片,其特征在于:所述内侧部支架(2)和所述外侧部支架(3)均采用车线缝制于所述封堵网片(1)上。
6.根据权利要求4所述的用于成人腹股沟疝TAPE术式修补的支架性补片,其特征在于:所述内侧部支架(2)和所述外侧部支架(3)均为镍钛合金支架;所述封堵网片(1)为聚丙烯网片。
7.根据权利要求4所述的用于成人腹股沟疝TAPE术式修补的支架性补片,其特征在于:所述防粘边涂层(5)术后完全吸收的时间为85~95天。
8.根据权利要求1或2或3所述的用于成人腹股沟疝TAPE术式修补的支架性补片,其特征在于:所述内侧部支架(2)的内侧边(22)上下两端与外侧边(21)之间均通过圆弧连接,所述外侧部支架(3)的内弧边(32)上端与外弧边(31)上端通过圆弧连接,所述外侧部支架(3)的内弧边(32)下端与外弧边(31)下端通过直线连接。
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