CN1226964C - 将支持线引入身体中以治疗妇女尿失禁的外科装置 - Google Patents

将支持线引入身体中以治疗妇女尿失禁的外科装置 Download PDF

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CN1226964C
CN1226964C CNB018203590A CN01820359A CN1226964C CN 1226964 C CN1226964 C CN 1226964C CN B018203590 A CNB018203590 A CN B018203590A CN 01820359 A CN01820359 A CN 01820359A CN 1226964 C CN1226964 C CN 1226964C
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J·莱赫
G·W·卡默雷尔
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Johnson and Johnson Medical SAS
Ethicon Inc
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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
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners

Abstract

一种用于将支持线引入身体中以治疗妇女尿失禁的外科装置，包括：一个细长弯曲的杆，该杆具有一个可插入身体内的末端，所述杆具有一个在其内沿所述杆长度的至少一部分延伸的空腔，所述空腔终止于所述末端，支持线可沿轴向通过所述空腔，所述杆具有一个设置于其外部表面上的槽，该槽沿长度的至少一部分与所述空腔是相通的，该槽起始于所述末端，该槽允许支持线侧向通过空腔而到达一个在杆之外的位置；一个带尖部件可移去地位于所述杆的所述末端上以使所述杆易于插入身体，该带尖部件的一端可连接支持线，所述带尖部件的尺寸可防止其在杆插入身体之时通过所述空腔；所述带尖部件是一个可弯曲的针，该针可滑动地容纳于所述空腔内，该针具有一个位于第一端部处的尖端和一个位于第二端部处的针眼，所述针眼可将线可移去地接纳于其内。

Description

将支持线引入身体中以治疗妇女尿失禁的外科装置
                       技术领域
本发明涉及外科方法及装置，更具体地说涉及一种通过植入一支持带来治疗妇女尿失禁的外科装置及相关方法。
                       背景技术
用于植入一在腹壁与尿道附近组织之间延伸的支持带或细丝以使尿道重新定位及给予其支持从而用来调整引起尿失禁的过度紧张的韧带的外科装置及方法是公知的。下面将对授予Petros的第512344号美国专利及授予Claren等的第5899909号专利进行进一步描述，以上两个专利中均公开了带尖的、弯曲的外科装置，所述装置具有可使其被引入进阴道、延伸通过阴道壁、围绕耻骨及通过腹壁以用于放置支持性的外科带或缝线的形状及尺寸。本发明提供另外一种可供选择的用于实现前述目的的装置和方法。
                       发明内容
本发明可克服与用于放置外科支持物以缓解妇女尿失禁的传统技术及装置相关的问题及缺点，本发明提供一种用于将支持线引入身体中以治疗妇女尿失禁的外科装置，包括：
一个细长弯曲的杆，该杆具有一个可插入身体内的末端，所述杆具有一个在其内沿所述杆长度的至少一部分延伸的空腔，所述空腔终止于所述末端，支持线可沿轴向通过所述空腔，所述杆具有一个设置于其外部表面上的槽，该槽沿长度的至少一部分与所述空腔是相通的，该槽起始于所述末端，该槽允许支持线侧向通过空腔而到达一个在杆之外的位置；一个带尖部件可移去地位于所述杆的所述末端上以使所述杆易于插入身体，该带尖部件的一端可连接支持线，所述带尖部件的尺寸可防止其在杆插入身体之时通过所述空腔；
所述带尖部件是一个可弯曲的针，该针可滑动地容纳于所述空腔内，该针具有一个位于第一端部处的尖端和一个位于第二端部处的针眼，所述针眼可将线可移去地接纳于其内。
                       附图说明
为了更好地理解本发明，下面将结合相应附图对示例性的实施例进行详细描述。其中：
附图1表示的是妇女生殖系统的前后向剖面图，其中尿道支持带处于合适的位置；
附图2表示的是生殖系统的前视图，其中也包含有附图1中所示的支持带；
附图3表示的是授予Petros的第5112344号美国专利中所述外科装置的分解图；
附图4表示的是与附图2相似的一幅视图，但其中显示的是现有技术中公知的另一种可供选择的带的位置；
附图5a和5b是表示Petros No.512344专利中所述装置在放置支持细丝操作中的局限性的两幅顺序相连的图；
附图6表示的是本发明中所述外科装置的透视图；
附图7表示的是本发明第二实施例中所述外科装置的透视图；
附图8表示的是沿附图7中所示装置中的VIII-VIII截面线且沿箭头所示方向看而获得的剖面视图；
附图9表示的是与附图8相似的一幅剖面视图，但其中显示的是本发明的第三个实施例。
                    具体实施方式
附图1和2表示出了一个环绕尿道U、在耻骨P周围延伸且穿过腹壁W的支持带10。可以通过公知的装置及方法来获得附图1中所示的结构，但附图1中所示的结构也是本发明的目的。例如第5899909号美国专利中就公开了一种用于将带10引入到附图1中所示身体位置处的外科装置及方法，鉴于该专利所给出的教导在此将其引入以作为参考。更具体地是，一段带10配置有一个连接于各端且针尖向外指的弯曲针(参见第5899909号专利)。第一针通过穿线连接于一个引入器手杆上，该针通过一个在阴道壁V上、围绕耻骨P且穿过腹壁W内表面的切口。将引入器从第一针上拆卸下来，将其连接于第二针上，该第二针被相类似地引导穿过身体中尿道U的另一侧以形成支持环。为了使支持带10易于通过患者组织，在带上覆盖一光滑的聚合物鞘。将带10置入体内后，将带切断以使之与针分离，将光滑鞘抽出以使带箍住其通过的组织且允许组织向内长。可从Somerville，N.J.公司Ethicon分部Gynecare买到这种装置。
在授予Petros的第5112344号美国专利中描述了另外一种外科装置及方法，其中所述装置I显示在附图3中，使用该装置可将一个支持细丝F放置在附图4所示位置处，鉴于该专利所给出的教导在此也将其引入以作为参考。更具体而言，Petros装置I具有一个细长弯曲的杆S，其内可滑动地容纳有一个可弯曲的针N，该针N具有一个尖端T和一个细丝F可穿过的针眼E。可在杆S上设置一个或多个握持件G以在其上形成杠杆系。根据Petros No.512344号专利，针N可置于杆S内，细丝F穿过且系于针眼E处。然后将针N和杆S的组合件引导进入阴道，尖端T穿透阴道壁V。按照附图1中带10所通过的大体弧形的路径引导杆S和针N通过人体，以便使尖端T穿过腹壁且允许将连接有细丝的针N从杆S中抽出。细丝F脱离针N以允许将杆S抽出。同时细丝F由从腹壁伸出的自由端所支持。将针N和杆S再次组装在一起且使之第二次再插入及穿过阴道壁V，且这次的位置转移到第一次插入位置的一侧。在针第二次从腹壁伸出时，将针N抽出(在该点处针上没有连接着细丝F)，作为装置I前次插入的结果而从腹壁延伸出的细丝F的自由端被连接到针N的眼部E处，且针N也被再次插入杆S中，由此携带细丝F的自由端进入阴道，细丝在此阴道处与针分开，之后将针N从杆S中移去且将杆S从人体中抽出。作为前述步骤的结果，如图4所示细丝在腹部表面上形成一个环且细丝的自由端延伸进入阴道。Petros No.512344专利还给出了下述教导：可以在疤痕组织形成之后将在那里起到带作用的细丝F从人体中抽出。
参见附图5a及5b，从图中可以看出：当附图3中所示装置I顺序两次从阴道V到腹壁W的前表面来穿入人体(附图5a中表示的是第一次穿入及附图5b中表示的是第二次穿入)时，该装置I不能被用来在尿道U周围形成细丝F环。更具体地，如附图5b所示，装置I本身陷入在细丝F环中以防止不剪断细丝F而将其移出的情况发生。
本发明中所述装置12显示在附图6中，该装置12在许多方面与附图3中所示装置I是相同的，也就是说与Petros No.512344中所给出的教导是一致的。更具体地说，装置12具有一个细长弯曲的杆14，其内可容纳针16，所述针的一端为一尖端18，所述针的另一端为一针眼20。杆具有多个从其一端处延伸的多个握持件22。装置12与Petros No.512344中所述装置的不同之处在于：杆14上具有沿其长度方向延伸的槽24，且所述槽与杆14的内腔26相通。槽24允许细丝F或附图1中所示的支持带10可从侧面引线穿过。因此槽24可弥补附图5b中所示情况，在不会破坏细丝F环的情况下，通过允许细丝14穿过槽24，槽24就可允许杆14与细丝F脱开。因此PetrosNo.512344中所描述的外科手术过程可改变为下述过程：在第一次插入装置12之后，可将针16插入杆14中且可将从阴道延伸的带10的自由端连于针16的眼部20中，其中这里所述的装置12的第一次插入是为了将细丝F或支持带10的第一部分从阴道携带到腹壁W的前表面处。然后再次将装置插入阴道且使之通过阴道壁而到达一个偏移开插入第一位置的另一位置处。当针16的尖端18穿透腹壁时，可将针16从杆14中抽出由此拖引着带10的自由端从阴道经过身体而到达一个相对于腹壁的外部位置处。然后将杆14从身体中抽出，将缝线或带10引穿过槽24以允许带10从杆14上脱开而将带10环完整地留在原处。然后通过拖拉从腹壁延伸的带10的自由端来对带10和尿道施加所需要的张力量。如果要将支持带10永久地留置在合适位置，则可按照类似于第5899909号美国专利中所公开的方法在阴道壁上切口以允许带在越过阴道壁的位置围绕尿道形成一个环。
附图7和8显示出了可供选择的另一装置112，该装置与前述的附图6中所示装置12具有相似的形状与功能。在下面的描述中，将采用相应的编号方式，即与前一实施例中具有类似功能的部件采用在前一实施例中所使用的相同附图标记只是在其前的百位上增加1后所组成的附图标记来表示。在附图7所示装置112中，支持带或细丝110的两端直接与尖端118型锻成形(附图7中只表示出了一端)。与前述相同，杆114的腔126小于尖端118，这样尖端118就被支持在杆114的端部上以在杆之前刺破组织从而允许杆114通过组织。与前面的实施例不同，槽124缩短了，其只沿杆114长度方向上的一部分延伸，起始于杆114的支持尖端118的那一端部附近。在利用装置112引导细丝110的一端以与上述相同方式通过身体之后，将杆114抽出且使之与细丝110脱开，将细丝110的相反一端置入杆114中，其中杆的末端部支持着相应的尖端118。尽管附图7显示出了细丝110直接与尖端118型锻成形的情况，但也可利用附图6中所示的具有针眼20和尖端18的可弯曲针16来作为将细丝110连接于其上的部件。在这种情况下，就不必要将细丝110的两端均连接于针16上了，而是可参见与附图6相应的描述来使针16与细丝110之间实现可移去地连接，这样就可进行重复使用了。
如附图9所示，杆214不必要沿其整个长度方向都是中空的，而是可以具有一个实心部分228，中空部分230从该实心部分处延伸。中空部分230包括有空腔或槽延伸部226以容纳细丝210。可通过在实心杆214中磨铣出槽延伸部226，槽延伸部226也可通过将杆214的一扁平部分辊压成管形而成形，也可通过锻压或浇铸成形。
应当理解为这里所描述的实施例仅仅是示例性的，本领域中的技术人员可以在本发明实质及范围的前提下进行多种变形或改变。

Claims (6)

1.一种用于将支持线引入身体中以治疗妇女尿失禁的外科装置，包括：
一个细长弯曲的杆，该杆具有一个可插入身体内的末端，所述杆具有一个在其内沿所述杆长度的至少一部分延伸的空腔，所述空腔终止于所述末端，支持线可沿轴向通过所述空腔，所述杆具有一个设置于其外部表面上的槽，该槽沿长度的至少一部分与所述空腔是相通的，该槽起始于所述末端，该槽允许支持线侧向通过空腔而到达一个在杆之外的位置；一个带尖部件可移去地位于所述杆的所述末端上以使所述杆易于插入身体，该带尖部件的一端可连接支持线，所述带尖部件的尺寸可防止其在杆插入身体之时通过所述空腔；
所述带尖部件是一个可弯曲的针，该针可滑动地容纳于所述空腔内，该针具有一个位于第一端部处的尖端和一个位于第二端部处的针眼，所述针眼可将线可移去地接纳于其内。
2.如权利要求1所述的装置，还包括有可与支持线的第二端相连接的第二个带尖部件。
3.如权利要求1所述的装置，其特征在于：所述槽小于所述针的直径以防止所述针侧向通过所述杆，所述针具有一个大于所述空腔的长度，以便于在将所述针插入所述空腔内时所述针眼伸出在所述杆之外。
4.如权利要求1所述的装置，其特征在于：所述杆具有一个呈实心横截面的第一部分和一个从第一部分延伸在其内具有所述空腔的第二部分。
5.如权利要求1所述的装置，其特征在于：所述空腔延伸通过所述杆的整个长度。
6.如权利要求1所述的装置，还包括有设置在所述杆上邻近所述相反端部的握持部。
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CA2426456C (en) 2009-11-17
AU9309501A (en) 2002-04-29
AU2001293095B2 (en) 2006-07-20
CN1484514A (zh) 2004-03-24
ES2356430T3 (es) 2011-04-08
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EP1335670A2 (en) 2003-08-20
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CA2426456A1 (en) 2002-04-25
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