CN108601651B - 用于将囊袋引入身体口袋的套组 - Google Patents

用于将囊袋引入身体口袋的套组 Download PDF

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CN108601651B
CN108601651B CN201580085040.3A CN201580085040A CN108601651B CN 108601651 B CN108601651 B CN 108601651B CN 201580085040 A CN201580085040 A CN 201580085040A CN 108601651 B CN108601651 B CN 108601651B
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pouch
carrier
kit
needle
balloon
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CN108601651A (zh
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方旭伟
马克·伯曼
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Biotegy Corp
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Biotegy Corp
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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
    • A61F2/12Mammary prostheses and implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02Dilators made of swellable material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3468Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02Devices for expanding tissue, e.g. skin tissue
    • 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
    • A61F2220/0008Fixation appliances for connecting prostheses to the body

Abstract

本发明提供一种用于将囊袋引入身体口袋的套组。套组包含具有一内表面(12)、一外表面(14)及至少一个开口端(16)的承载器(10)、一球囊导管(20)、一缝针(40)以及一囊袋(30)。承载器(10)包括形成于外表面(14)上的针鞘(18);球囊导管(20)包含一球囊(22)及一导管(24)。缝针(40)以缝线(50)固定至囊袋(30)。囊袋(30)可置于承载器(10)中,而缝针(40)则收纳于针鞘(18)中。囊袋(30)可具有一入口(32)及一开口(34)。经由入口(32),可在囊袋(30)被放置进入身体口袋后,将球囊导管(20)及一身体假体引入囊袋(30)中,球囊导管(20)的导管(24)可经由开口(34)引出囊袋(30)外。

Description

用于将囊袋引入身体口袋的套组
技术领域
本发明关于一种用于将囊袋引入身体口袋的套组。更具体地,本发明关于一种用于将如美国第6,146,418号专利的囊袋引入身体口袋的套组。
背景技术
美国第6,146,418号专利(‘418专利)揭示一种身体植体以及植入的方法。如‘418专利所描述的植体具有由生物兼容的柔性聚合物所制成的独立囊袋,在该囊袋被引入皮下身体口袋后,可将移动装置或假体置入该囊袋中。通过身体组织长入该囊袋的孔洞中,使该囊袋形成具有最小球体包膜挛缩的人工疤痕。在本申请案中,申请人发展出一种适用于将这类囊袋引入并进行后续手术的完整套组。
发明内容
本发明提供一种用于将囊袋引入身体口袋的套组,其包含一承载器、一球囊导管、一囊袋及一缝针。该承载器具有一内表面、一外表面以及至少一个开口端。此外,该承载器包括形成在该承载器外表面上的一针鞘。该球囊导管包含一球囊及一导管。该缝针通过一缝线固定至该囊袋。该囊袋可置于该承载器中,而该缝针则收纳于该针鞘中。该囊袋具有一入口及一开口。在该囊袋放置进入该身体口袋后,该入口允许该球囊导管及一身体假体被依序地引入该囊袋中。另外,在将该球囊导管置入该囊袋后,可经由该开口将球囊导管的该导管引出该囊袋外。
在本发明的特定具体实施例中,该套组进一步包括一盖子。该盖子适于与该承载器及该针鞘结合,且在该缝针收纳于该针鞘中时,可用于覆盖该开口端及该缝针的针尖。
在本发明的一具体实施例中,该承载器进一步包括配置于该开口端的一相对端的推杆。该推杆可用于将该囊袋自该开口端推出而进入该身体口袋。
根据本发明,该承载器可包括三个或更多个、或四个或更多个,以等距而环绕地形成于该承载器的外表面的针鞘。因此,该套组可包含三个或更多个、或四个或更多个,各以缝线固定至该囊袋的缝针。
应理解的是,前述的一般性说明及以下的详细说明皆仅为示例性及说明性的,并不限制本发明。
附图说明
配合附图一起阅读时将能更佳地理解前述发明内容,以及以下的详细说明。在附图中:
图1A为根据本发明的一具体实施例的用于将一囊袋引入身体口袋的套组中的承载器的立体图。
图1B为根据本发明一个具体实施例的用于将一囊袋引入身体口袋的套组中的球囊导管的立体图。
图2A为根据本发明一个具体实施例的用于将一囊袋引入身体口袋的套组中的囊袋顶部的立体图。
图2B为根据本发明一个具体实施例的用于将一囊袋引入身体口袋的套组中的囊袋侧边的立体图。
图3为图1所示承载器的盖子的立体图。
具体实施方式
参照图1A-2B,所示为根据本发明的用于将囊袋引入身体口袋(未显示)中的一套组。该套组包含一承载器10、一球囊导管20、一囊袋30以及一个或多个缝针40。该承载器10具有一内表面12、一外表面14以及至少一开口端16。为了收纳一个或多个缝针40,该承载器10包括分别地形成于该承载器10的外表面14上的一个或多个针鞘18。此外,承载器10可进一步包括配置于该开口端16的相对端15的推杆19。该球囊导管20包含一球囊22以及一导管24。该球囊导管20可为连接于长约20cm且直径为3-4mm的硅胶管的硅胶球囊。该球囊22,在其收缩的形态下,能够从该导管露出的相同切口位置抽出。在其膨胀的形态下,球囊22可以生理食盐水膨胀至达300mL或400mL的容积,而180mL为最常建议的膨胀容积。囊袋30可为根据美国专利第6,146,418号(‘418专利)的囊袋,该专利通过引用而将其全文并入本文中。缝针40各通过一缝线50固定至该囊袋30(例如,不可吸收的双股单纤缝线50)。该囊袋30可被可拆卸地置于承载器10中,而缝针40则收纳在针鞘18中。另外,如图2所示,该囊袋30具有一入口32及一开口34。如‘418专利所述,将囊袋30放置进入身体口袋(未显示)中后,可将球囊导管20及一身体假体(例如,乳房植体)(未显示)经由该入口32引入囊袋30中;而该开口34用于将球囊导管20的导管24自该囊袋30内引出。
较佳地,该承载器10具有大致上为中空的圆柱型,但不限于此。该承载器10可由生物兼容性材料(诸如生物兼容性聚合物)制成。该缝针40的实例包括但不限于长度约3英寸的直缝针。
举例而言,为了进行乳房假体植入,在病患体内形成一个口袋,并制造一伤口作为该口袋的入口。包含囊袋30以及缝针40的承载器10被放置于该伤口上方。然后,一个接着一个地将缝针40从针鞘18移除,再分别从合适的位置穿进该口袋中,并从皮肤穿出。接着,该承载器10是由该承载器10的开口端16插入伤口而进入该口袋中,且以推杆19和缓地将囊袋30推入该口袋中。当然,若承载器10没有配置推杆时,亦可使用钳子将囊袋30推入口袋中。接着拉紧缝线50以进一步固定囊袋30,同时使开口34与伤口对齐。另可选择地,该囊袋30一开始可不包含入口32及/或开口34,而开口34在手术的此阶段可由开刀者制造。该缝线应暂时固定在右、左及内侧衬垫上(未显示)。然后,将球囊导管20经由入口32引入囊袋30中,且将球囊导管20的球囊22放置于合适的位置上(例如,最常是放在囊袋的前部)。接着,将球囊22的导管24经由开口34而引出至该囊袋30之外。这通常以蚊式钳通过一外部皮肤切口及通过囊袋的一开口(可通过简易的穿刺而制备或制造)引出。球囊导管的远程部位(导管部位)是由钳子抓着并通过皮肤开口抽出。接着,可将50-1,000mL的盐水(含有抗生素)注入囊袋30中。由入口32将乳房植体植入囊袋30中,然后以钝尖抽吸器(扬克氏装置;Yankauerdevice)将填满囊袋及口袋空间的盐水抽除,此时,即可将缝线50修剪并从囊袋30处移除。最后,经由导管24注入无菌的生理食盐水而使球囊导管20的球囊22膨胀,由此使囊袋30撑起至周边处而可最大地覆盖着口袋,并封闭伤口。进行手术后三天至一周,可将球囊导管20经由开口34自囊袋移除。
参照图3,为了安全,本发明的套组可进一步包括盖子60。盖子60适于与承载器10以及针鞘18结合,以在缝针40分别被收纳于针鞘18中时,覆盖开口端16以及缝针40的针尖。
应当理解,在不需进一步阐明的情况下,本发明所属领域的技术人员可依据本揭示而最广范围地利用本发明。因此,应理解所提供的说明为示例的目的,并不在任一方面限制本发明。

Claims (9)

1.一种用于将囊袋引入身体口袋的套组,其包含:
(a)一承载器,其具有一内表面、一外表面及至少一开口端,该承载器包括形成于该外表面上的一针鞘;
(b)一球囊导管,其包含一球囊及一导管;
(c)一囊袋,其可拆卸地放置于该承载器中;及
(d)一缝针,其通过缝线固定至该囊袋。
2.根据权利要求1所述的套组,其进一步包含适于与该承载器及该针鞘结合的一盖子,以在该缝针收纳于该针鞘中时,覆盖该开口端及该缝针的针尖。
3.根据权利要求1所述的套组,其中,该承载器进一步包含一推杆,其配置于该开口端的一相对端。
4.根据权利要求1所述的套组,其中,该承载器包含三个或更多个针鞘,其等距而环绕地形成于该承载器的该外表面。
5.根据权利要求4所述的套组,其包含三个或更多个缝针,其各以缝线固定至该囊袋。
6.根据权利要求1所述的套组,其中该承载器包含四个或更多个针鞘,其等距而环绕地形成于该承载器的该外表面。
7.根据权利要求6所述的套组,其包含四个或更多个缝针,其各以缝线固定至该囊袋。
8.根据权利要求1所述的套组,其中,该囊袋具有一入口,在该囊袋被放置进入该身体口袋后,能够经由该入口将该球囊导管及一身体假体引入该囊袋中。
9.根据权利要求1所述的套组,其中,该囊袋进一步包含一开口,经由该开口能够将该球囊导管的该导管引出该囊袋外。
CN201580085040.3A 2015-12-03 2015-12-03 用于将囊袋引入身体口袋的套组 Expired - Fee Related CN108601651B (zh)

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US6146418A (en) * 1997-02-28 2000-11-14 Berman; Mark Body implant and method of implanting
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CN108601651A (zh) 2018-09-28
EP3383316A4 (en) 2019-07-31
EP3383316A1 (en) 2018-10-10
WO2017091999A1 (en) 2017-06-08
KR102092489B1 (ko) 2020-03-24
KR20180098257A (ko) 2018-09-03
BR112018010920A2 (pt) 2018-11-21

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