CN114587703A - 一种可降解输尿管支架 - Google Patents

一种可降解输尿管支架 Download PDF

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CN114587703A
CN114587703A CN202210302180.3A CN202210302180A CN114587703A CN 114587703 A CN114587703 A CN 114587703A CN 202210302180 A CN202210302180 A CN 202210302180A CN 114587703 A CN114587703 A CN 114587703A
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main body
stent
degradable
ureteral stent
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曹烽
熊成东
包一红
陈和春
包一良
曹湘湘
徐秀忠
李宝春
陈栋梁
张志萍
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Zhejiang Zhongzai Medical Technology Co ltd
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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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/048Ureters
    • 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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

本发明涉及一种可降解输尿管支架,包括支架主体,支架主体的上端设置有口,支架主体的下端弯曲形成圆形阻力圈用于固定在膀胱内输尿管口处,支架主体上设置有能够向外延展的卡设部,卡设部和阻力圈间设置有一过渡条。本发明结构简单,设计紧凑,使用方便,输尿管支架能在体内完成降解后排出,避免了二次手术对输尿管造成的损害,减轻了患者的痛苦;卡设部坐卡在输尿管进入膀胱壁内部的入口处,固定支架不会向膀胱内发生移动,解决了可降解输尿管支架采用猪尾圈肾盂内悬挂固定方式降解时,产生的碎片从肾盂排出时间不可控的问题,支架主体上设置的过渡条有效阻止了膀胱尿液的返流。

Description

一种可降解输尿管支架
技术领域
本发明涉及一种可降解输尿管支架,属于医疗器械技术领域。
背景技术
临床通常使用的不可降解的输尿管支架是一根一头或两头弯成猪尾圈状的空心长管,具有保持输尿管通畅的作用。输尿管支架通常从膀胱输尿管口入路,以猪尾圈肾盂内悬挂固定方式保持输尿管支架在输尿管内的位置稳定,使用完毕后,需经二次手术拔出。不可降解输尿管支架的拔出,增加了患者的痛苦和经济负担,并有造成输尿管损伤的风险,由此也导致了对输尿管检查、治疗造成的可能损伤进行术后预防性保护的顾虑,因此,临床迫切期望可降解输尿管支架。
但是,采用肾盂内固定结构的可降解输尿管支架,经过降解断碎的管段,会较长时间地滞留在肾盂内,虽大部分降解产物会排出体外,但排出时间不可控,存在不良事件风险,容易影响肾脏健康和输尿管的后续治疗,另外,输尿管支架以空心圆管停留于输尿管壁内部,无论是否降解都会导致膀胱尿液返流。
发明内容
本发明的目的是为了解决上述问题,提供了一种结构简单,设计紧凑的可降解输尿管支架。
本发明采用如下技术方案:包括支架主体,所述支架主体的上端设置有开口,所述支架主体的下端弯曲形成圆形阻力圈用于固定在膀胱内输尿管口,所述支架主体上设置有向外延展的卡设部,卡设部能够固定在输尿管盆部与膀胱内壁部交界处,所述卡设部和阻力圈间设置有一过渡条。
进一步的,所述卡设部为弹性卡片,卡片至少为1个。
进一步的,所述卡片呈卷曲状。
进一步的,所述过渡条为C形弧条、直径小于支架主体管的实心细柱或直
条、边缘有波形的C形弧条。
进一步的,所述过渡条的长度为0.5-1.5cm。
进一步的,所述卡设部为伞状结构或其他骨架形结构。
进一步的,支架采用可生物降解聚合物制成。
进一步的,所述卡片设置在支架主体上与阻力圈最高点相距1.5-2cm位置处。
进一步的,所述卡片能够以与支架主体的连接点为支点展开形成任意角,角的开口朝向阻力圈方向,且卡片展开后能够卡设在输尿管盆部与膀胱壁内部交界处。
进一步的,所述支架主体上端的开口为水平开口或斜面开口。
本发明的有益效果:
(1)本发明结构简单,设计紧凑,使用方便,采用可生物降解聚合物材料能够在体内完成降解后排出,避免了二次手术对输尿管损害的风险,减轻了患者的痛苦。
(2)本发明采用卡设部坐卡在输尿管从盆部进入膀胱壁内部的入口处,固定方式简单稳固,支架不易移动,避免了采用猪尾圈进行肾盂内悬挂的固定方式,从根本上解决了支架降解产物对肾盂的影响。
(3)建立了支架排出时间与支架材料降解时间的直接应答,实现了临床上支架排出时间的可控性。
(4)支架主体上过渡条的设置,避免了圆形支架管对输尿管壁内部管腔闭合功能的阻碍,有效解决了膀胱尿液返流的问题。
附图说明
图1为本发明的结构示意图。
图2为本发明的结构示意图。
图3为本发明的结构示意图。
附图标记:支架主体1、卡设部2、过渡条3、阻力圈4。
具体实施方式
下面将结合附图对本发明作进一步的描述。
如图1所示,一种可降解输尿管支架,支架采用可生物降解材料制成,包括空心圆管的支架主体1,所述支架主体1的下端弯曲形成阻力圈4用于固定在膀胱内输尿管口,所述支架主体1的上端为水平开口,支架主体1的中间部分设置有向外延伸的弹性卡片,卡片设置在支架主体1上,卡片至少包括1片;卡片的根部设置在支架主体1上与阻力圈4最高点相距1.5-2cm位置处,卡片能够以与支架主体1的连接点为支点展开成任意角,且卡片展开后能够坐卡于输尿管盆部与膀胱壁内部交界处,卡片形状为长条卷曲状且端部呈圆形或者为其他任意形状,卡片进入输尿管盆部后展开的范围大于输尿管壁内部的直径,因此能够使支架稳固放置而不会滑入膀胱,卷曲状的卡片能够减轻对输尿管内膜的刺激,卡片对称地均布在支架主体上,支架主体1上设置有过渡条3,过渡条3包括C形弧条,C形弧条设置在阻力圈与卡片间,C形弧条与卡片间保留设置有一段支架主体管,C形弧条的长度为0.5--1.5cm,C形弧条的设置既能保证输尿管支架在置入过程中不受影响,又能保全输尿管壁内部的管腔闭合功能,从而起到阻止尿液由膀胱向输尿管返流的作用,支架主体上布设有多个透气小孔。
卡设部为伞状结构围绕设置在支架主体上或其他骨架形结构如网状设置在支架主体上,如图2所示,过渡条为有波浪形边缘的C形管;如图3所示,过渡条为直线实心细柱。
选择符合要求的可降解生物材料,按规格要求挤出支架原料管,截取设计规格长度的原料管作为支架主体,末端弯曲形成阻力圈,在直管内插入冲压垫丝,在直管上标记出与阻力圈最高点的定位点,根据定位点,采用冲压模具在支架主体上冲压出卡片,并处理卡片使其弯曲外翘呈卷曲状,冲压形成C形过渡弧条,标记刻度位置,完成加工工艺,包装灭菌形成输尿管支架产品。
使用方法:根据临床对输尿管支架置入时间长短的要求及患者输尿管检查结果选择适宜降解时间和规格的可降解输尿管支架;将可降解输尿管支架从膀胱输尿管口入路,循导丝推入尿道、膀胱、输尿管壁内部,支架主体上设置有刻度线,用于标记输尿管进入的长度,注意支架主体上的刻度提示,待卡片进入输尿管盆部时,即停止推送,回拉支架主体,感觉明显有阻力时停止,此时支架主体下端的阻力圈应贴住膀胱输尿口外,抽出导丝,输尿管支架放置完毕。卡片在回拉过程中被充分展开,能够坐卡于输尿管盆部与膀胱壁内部交界处,因此输尿管支架不会滑落。达到输尿管支架材料预定降解断裂时间后,卡片随支架主体一起降解断裂,支架残体可从输尿管直接进入膀胱,随之经尿道排出体外,达到“即废即排”的要求。根据支架所采用的可生物降解聚合物降解时间的不同,能够明确降解产物排出人体所需用的时间,从而使临床能够实施精准的治疗方案。

Claims (9)

1.一种可降解输尿管支架,其特征在于:包括支架主体(1),所述支架主体(1)的上端设置有开口,所述支架主体(1)的下端弯曲形成圆形阻力圈(4)用于固定在膀胱输尿管口,所述支架主体(1)上设置有向外延展的卡设部(2),卡设部(2)能够固定在输尿管盆部与膀胱壁内部交界处,所述卡设部(2)和阻力圈(4)间设置有一过渡条(3)。
2.如权利要求1所述的可降解输尿管支架,其特征在于:所述卡设部为弹性卡片,卡片至少为1个。
3.如权利要求2所述的可降解输尿管支架,其特征在于:所述卡片外翘呈卷曲状。
4.如权利要求2所述的可降解输尿管支架,其特征在于:所述卡片能够以与支架主体(1)的连接点为支点展开形成任意角,角的开口朝向阻力圈(4)方向,且卡片展开后能够卡设在输尿管盆部与膀胱壁内部交界处。
5.如权利要求1所述的可降解输尿管支架,其特征在于:所述卡设部(2)为伞状结构或其他骨架形结构。
6.如权利要求1所述的可降解输尿管支架,其特征在于:所述过渡条(3)为C型弧条、直径小于支架主体管的实心细柱或直条、边缘有波形的C形弧条。
7.如权利要求1所述的可降解输尿管支架,其特征在于:所述过渡条(3)的长度为0.5-1.5cm。
8.如权利要求1所述的可降解输尿管支架,其特征在于:所述卡设部(2)设置在支架主体(1)上与阻力圈(4)最高点相距1.5-2cm位置处。
9.如权利要求1所述的可降解输尿管支架,其特征在于:所述支架主体(1)上端的开口为水平开口或斜面开口。
CN202210302180.3A 2022-03-24 2022-03-24 一种可降解输尿管支架 Pending CN114587703A (zh)

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