CN1646067A - 用于治疗女性患者骨盆器官脱垂的方法和装置 - Google Patents

用于治疗女性患者骨盆器官脱垂的方法和装置 Download PDF

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CN1646067A
CN1646067A CNA038076225A CN03807622A CN1646067A CN 1646067 A CN1646067 A CN 1646067A CN A038076225 A CNA038076225 A CN A038076225A CN 03807622 A CN03807622 A CN 03807622A CN 1646067 A CN1646067 A CN 1646067A
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B·雅克坦
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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
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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
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure 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
    • A61F2/0036Closure 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
    • A61F2/0045Support slings
    • 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
    • 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

Abstract

适于治疗存在于女性患者的中心性和外侧膀胱膨出的前部植入物(10),其包括不依赖患者的盆筋膜腱弓用于支撑位于患者的膀胱和阴道之间的所述植入物的向外延伸的稳定带(42,44)。直肠膨出和子宫脱垂修补可通过使用单独的后部植入物(50)而实现,和前部植入物一样,其装备有用于支撑位于患者的直肠和阴道之间的所述植入物的向外延伸的稳定带(68,70)。

Description

用于治疗女性患者骨盆器官脱垂的方法和装置
发明的技术领域
本发明涉及用于治疗女性患者骨盆器官脱垂的手术装置和方法。
背景技术
女性,通常由于衰老,可出现三种基本的骨盆器官脱垂类型。这些脱垂或缺陷如下:膀胱膨出、子宫脱垂和直肠膨出。
膀胱膨出出现于膀胱突入阴道时。如果所述缺陷局限于中心区,其通常称为中心性膀胱膨出。如果所述缺陷向外侧延伸超过任何所述中心区,所述向外延伸部分通常称为外侧膀胱膨出。膀胱膨出通常经前部修补进行治疗,以往,所述前部修补包括缝合法或使用适于以吊带样形式支撑膀胱的植入物(参见例如美国专利5,840,011和世界知识产权组织(WIPO)公布WO 02/38079 A2)。已知的缝合法复发率高。尽管已经证实用于中心性膀胱膨出的治疗效果良好,但前述植入物本质上并非为治疗外侧膀胱膨出而设计。
直肠膨出出现于直肠突入阴道时。这种类型的缺陷经后部修补进行治疗,以往,所述后部修补包括阴道顶部至主韧带和子宫骶骨韧带的悬吊。这些方法的变异通过使用不同的网眼材料而实现。
子宫脱垂出现于子宫降入阴道,导致阴道穹窿下降时。所述缺陷的常规治疗是子宫切除术伴阴道穹窿悬吊,所述阴道穹窿悬吊通过,例如,将所产生的阴道断端和提肛肌、尾骨肌或骶棘韧带之一(而非双侧)相连而实现(Richter法)。
发明的公开
本发明的一个方面涉及一种新的并且改良了的前部植入物和使用其进行女性患者膀胱膨出的修复的方法。更具体地,所述前部植入物包括适于治疗外侧膀胱膨出的内侧区域和一对位于侧面的外侧区域,它们均适于治疗外侧膀胱膨出。将所述前部植入物的体部置于患者的膀胱和阴道之间后,将向外延伸带穿过患者的闭孔和患者会阴的相应的皮肤切口。所述延伸带在两侧发挥稳定所述前部植入物的作用,其不依赖患者的盆筋膜腱弓(arcus tendineous fascia pelvis)。在一个实施例中,所述前部植入物配有一对稳定带,所述植入物两侧一边一条。在另一个实施例中,所述前部植入物配有两对稳定带,一对自所述前部植入物的一侧向外延伸并且另一对自所述前部植入物的对侧向外延伸。
本发明的另一个方面涉及一种新的并且改良了的后部植入物和使用其治疗女性患者的直肠膨出和/或子宫脱垂的方法。所述后部植入物包括用于在直肠和阴道之间支撑后部植入物的体部的向外延伸带,并且还通过其对骶棘韧带的附着起进行阴道穹窿悬吊的作用。
附图简介
为了更好地理解本发明,参考下列各种典型实施方案的详细描述以及附图,其中:
图1为根据本发明所制作的前部植入物的一个典型实施方案的顶面图;
图2为根据本发明所制作的后部植入物的一个典型实施方案的顶面图;
图3为经手术方法使用图1和2的所述植入物后的女性骨盆解剖插图;
图4和5说明经闭孔通道的两个步骤,其作为图3所述及的手术方法的一部分被完成;
图6显示图1和2的所述植入物被植入女性患者体内;
图7显示图1的前部植入物在女性患者的膀胱和阴道之间的位置;
图8和9显示图2的后部植入物在女性患者的直肠和阴道之间的位置;
图10为根据本发明所制作的前部植入物的另一个典型实施方案的顶面图,并且
图11为根据本发明所制作的后部植入物的另一个典型实施方案的顶面图。
实施本发明的最佳方式
参阅图1,前部植入物10包括下方部分12和上方部分14。尽管被区分为两个独立的部分,但可以理解的是:前部植入物10优选用任何适宜的单片生物相容性网眼材料来制造,例如编织聚丙烯织物(如,美国,新泽西,萨默维尔的Ethicon公司销售的软PROLENE网眼织物)。因此,图1中用虚线表示不同部分的假想界线(即,在剖视图中)以便于前部植入物10的描述和讨论。
现回到图1,下方部分12(其为大体的漏斗样形状)通过长度范围自约2cm至约5cm的直的下部边缘16、长度范围自约8cm至约14cm的假想边界18(见图1中剖视图),和一对和女性患者骨盆解剖的弓形近似的呈复合弓形的凹形侧边20,22而界定。角24,26分别由下部边缘16和凹形侧边20,22汇合而形成。应当注意的是:下部边缘16可被延伸约3cm(如图1中剖视图所示)以实现下文中所述的目的。
下部边缘16和假想边界18之间的距离D1也随患者的骨盆解剖而定,但典型地在约4cm至约8cm的范围之内。当然,用于制造前部植入物10的网状织物的特性为:外科医生可修改下方部分12的大小和形状以满足特殊患者的需要。换句话说,前部植入物10的下方部分12可在手术台上被定制使其合身。
仍然参阅图1,上方部分14(其为大体的穹顶样形状)通过和下方部分12的假想边界18、有确定的半径(如,约2cm至约4cm)和弓形长度(如,约2cm至约4cm)以避免和患者的膀胱颈接触的弯曲的上部边缘28,和一对和盆筋膜腱弓(ATFP)的弓形近似的呈复合弓形的凸形侧边30,32而界定。上方部分14的凸形侧边30,32分别和下方部分12的凹形侧边20,22汇合,分别形成角34,36,而角38,40分别由上方边缘28与凸形侧边30,32汇合而成。
距离D2,其沿前部植入物10的中央纵轴(L)而测量并且位于假象边界18和上部边缘28之间,随患者的骨盆解剖而定。通常,距离D2在约3cm至约5cm的范围之内。和下方部分12一样,上方部分14适于在手术台上定制使其合身以满足患者的特殊需要。因此,可以理解的是:上方部分14的形状和大小可由外科医生在手术过程中进行制造后修正。
继续参阅图1,带42,44自上方部分14的相对的侧面向外延伸。更具体地,带42自上方部分14的凸形侧边30向外横向延伸,而带44自上方部分14的凸形侧边32向外横向延伸。带42,44,其功能将在下文中详细进行描述,典型地宽度范围自约0.5cm至约2cm,并且长度范围自约7cm至约15cm。尽管带42,44优选具有如图1所示的轻度弯曲,它们亦可分别自前部植入物10的凸形侧边30,32以线性方式延伸。如上所述,外科医生可容易地通过,例如,用剪刀或其它适宜的剪切工具剪切它们来改变带42,44的宽度和长度。
假想边界线46,48,其通常平行于中央纵轴(L)延伸,将前部植入物10的体部分为一个内侧区域A1和两个外侧区域A2、A3(其在内侧区域A1的侧面)。区域A1、A2和A3并非精确的。通常而言,区域A1指按照下文中详细描述的手术方法起修补中心性或内侧膀胱膨出作用的前部植入物10中的部分,而区域A2、A3指按照同样的方法起修补外侧膀胱膨出作用的前部植入物10中的那些部分。
现参阅图2,后部植入物50包括下方部分52,上方部分54和带状部分56。和前部植入物10一样,后部植入物50由任何适宜的单片生物相容性网状材料制成。尽管后部植入物50在图2中被分开并且独立于前部植入物10而描绘,但可以理解的是:正如将于下文中更加详细描述的那样,后部植入物50可和前部植入物10作为整体而形成。如同描述图1的前部植入物10那样,图2的后部植入物50的各个部分的假想边界也用虚线(即,在剖视图中)表示以便描述和讨论。
现回到图2,带状部分56,其被插入下方部分52和上方部分54中间,有一个以虚线60、62、64和66为界并且长度约5cm、宽度约0.5至2cm的近似长方形的假想中心区域58。带状部分56还包括一对自假想中心区域58的相对的两个末端向外延伸的带68,70。带68,70,其功能将于下文中进一步详细地描述,典型地宽度范围自约0.5cm至约2cm,长度约4cm(如果带68,70被连接至并终止于骶棘韧带的话),或长约20cm(如果带68,70经臀部穿过盆底并且穿过或不穿过骶棘韧带的话)。尽管带68,70优选具有如图2所示的轻微的弯曲,但它们亦可自后部植入物50的相对的两个侧面以线性方式延伸。给定用于制造后部植入物50的网状材料的特性,带68,70的宽度和长度可容易地由外科医生进行修正以满足特定患者的需要。
继续参阅图2,下方部分52,其为大体的三角形,自带状部分56向下垂。更具体地,下方部分52通过长度范围自约1.5cm至约3.5cm的直的下部边缘72和一对直的或轻度向内弯曲的向下的凹形侧边74,76而界定。尽管侧边74,76的长度典型地为约8cm至约12cm,但本领域技术人员可以理解的是:下方部分52的外形尺寸(包括侧边74,76的长度)随患者的骨盆解剖而变。更具体地,下方部分52的大小和形状经特别地选择用于修补直肠膨出的目的。本领域技术人员亦可理解:下方部分52的大小和形状可由外科医生进行制造后修正。在无需直肠膨出修补而只需要阴道穹窿悬吊的情况下,下方部分52和上方部分54均可从后部植入物50中去除,留下带状部分56进行阴道穹窿悬吊。
继续参阅图2,上方部分54,其游离端通过上方边缘78而界定并且近似于长度约3cm且宽约1cm的长方形的形状,自带状部分56向上延伸。上方部分54的主要用途在于提供连接后部植入物50至前部植入物10的方法。因此,对于不需要前部植入物10的患者,可以理解的是:后部植入物50的上方部分54可在将所述后部植入物50植入所述患者体内前被外科医生去除。同样可以理解的是:外科医生可另行修改上方部分54的大小和形状以满足他(她)的需要,例如当连接后部植入物50至前部植入物10时。例如,上方边缘78可被延伸约3cm(如图2中剖视图所示)以便于后部植入物50和前部植入物10的连接。此外,所述连接可通过延伸如上所述的前部植入物10的下方边缘16而变得容易。
前部植入物10和后部植入物50均可自一大块前面提到过的网状织物中剪切或冲压出。如果需要,剪断的纤维的游离端可通过本领域中已知的任何适宜的技术进行处理以防止散开。
前部植入物10和后部植入物50可以各种标准的形状和大小(例如,小号、中号和大号)被提供。比较这些标准植入物和特定患者的骨盆解剖后,外科医生可选择其中最符合患者需要的一个。如果需要对所选择的植入物的大小和/或形状进行任何修改,其可由外科医生在手术台上完成。
前部植入物10常用于进行膀胱膨出的前部修补,而后部植入物50常用于进行直肠膨出的后部修补。阴道穹窿悬吊可使用前部植入物10和/或后部植入物50进行。所有这些治疗方法将在下文中进行更详细地讨论。
I.概述
标准的阴道子宫切除术通常先于所有根据本发明进行的盆底修补术。因此,如图3所示,阴道(V)没有被绘制成和子宫相连。
继续参阅图3,膀胱膨出通过用图1的前部植入物10进行前部修补而治疗。简而言之,所述治疗包括前部植入物10在阴道(V)和膀胱(B)之间的放置。
图3还对如何通过图2的后部植入物50进行后部修补治疗直肠膨出进行了描绘。简而言之,所述治疗包括后部植入物50在阴道(V)和直肠(R)之间的放置。
由于子宫(未显示)已经从阴道(V)上摘除,图3中还对顶部修补进行了描绘。简而言之,所述修补包括使用前部植入物10和/或后部植入物50进行阴道穹窿悬吊。
II.前部和侧面的修补
A. 阴道前壁的切开
纵向切开阴道前壁全层厚度以生成一个适当大小的前部阴道切口。如果顾及膀胱颈区和阴道顶部,前中部阴道切开术可始于距阴道穹窿3cm处并且终于距膀胱颈至少1cm处。如果只顾及膀胱颈区,前中部阴道切开术可始于阴道穹窿并且终于距膀胱颈至少1cm处。尽管附图中没有描绘,但这些过程为本领域中专业人员所熟知。
B. 膀胱分离
这是众所周知的过程,其在附图中没有被描绘,它包括侧面分离直到阴道的直肠子宫陷凹。随后检查内骨盆筋膜(endopelvic fascia)的完整性。
在没有缺损的情况下,所述分离沿所述筋膜面进行直到到达耻骨支的下缘。将剪刀插入肛提肌和骨之间后,将手指穿过所形成的开口并且随后推进至其得以触及闭孔膜。所述过程通常被称为提肌上通道。
另一方面,如果发现侧面缺损或筋膜非常薄,首先用手指打开膀胱旁窝。由于盆筋膜腱弓的完全分离是没有必要的,因此手指通过肌性骨盆侧壁(肛提肌和闭孔肌)触摸闭孔。所述过程通常被称为经提肌通道。
C. 膀胱前筋膜折叠术
该过程典型地使用2/0可吸收单丝线连续缝合而完成。尽管附图中没有描绘,但所述过程已为本领域技术人员所熟知。
D. 经闭孔通道
该过程在图4和5中进行了描绘。用于所述通道的理想区域是闭孔的下部和中部,稍高于坐骨耻骨支(PR)。其位于腱弓水平以内并且外科上可通过两指触诊确定。
参阅图4,外科医生可使用手术刀(K),例如解剖刀,在大阴唇外侧顶着外科医生的食指(IF)尖划出一个5mm的皮肤切口(SI1)。将适于穿线(S1)的常规的弯曲并且有眼的针(N)穿过闭孔(OF)并且随后在坐骨耻骨支(PR)周围推进直到其得以触及外科医生的食指(IF)尖。
现在参阅图5,用外科医生的食指(IF)引导所述针(N)并且穿过前部阴道切口(未显示)推进至其到达阴道口(VO)。外科医生现在可用他(她)的食指钩住线(S1)的环形末端,通过阴道口(VO)将其从患者体内抽出。将线(S1)自针(N)上卸下并且将针(N)经皮肤切口(SI1)退回后,线(S1)随意地置于经闭孔通道内准备如下文将述及的那样用于图1的前部植入物10的固定。
随后可在患者的对侧使用同一根针(N)或另一个同样的针进行同样的过程。结果将是:现在有两根自两个皮肤切口(SI1)和(SI2)延伸至阴道口(VO)的线(S1)和(S2),它们被准备用于固定前部植入物10(见图6)。
E. 前部植入物固定
具体参阅图6,两根线(S1)和(S2)被显示分别和前部植入物10的带42,44连接。如图6所描绘,线(S1)和(S2)分别被按箭头AR1和AR2的方向拉紧,同时外科医生将前部植入物10通过阴道口(VO)并且随后经前部阴道切口(未显示)插入患者体内。当线(S1)和(S2)继续分别经皮肤切口(SI1)和(SI2)被取回时,带42,44穿过它们相应的闭孔膜,最终分别经皮肤切口(SI1)和(SI2)显露出来。带42,44均被给予恰当的拉力以便前部植入物10尽可能地适应患者的周围的组织。随后带42,44在皮肤表面被切断并无需任何额外固定地被弃置。前部植入物10现在可如图3所示被侧面固定于膀胱(B)和阴道(V)之间。当内盆筋膜强壮时,可将带42,44从前部植入物10上切断,从而避免所述经闭孔通道。在这种情况下,前部植入物10可通过其两侧的两根线被侧面固定。
现在参阅图7,以及图3,前部植入物10在角38,40附近用一针可吸收0号编织线双侧固定于邻近其插入处的耻尾肌(PM)的前部,从而实现所述装置的前部固定。前部植入物10还在角24,26附近用一针编织可吸收0号线双侧固定于距阴道断端(VC)1至2cm的子宫骶骨韧带(US1)和(US2)。或者,如果进行后部修补,前部植入物10的所述后部固定可通过双侧和骶棘韧带(SS1)和(SS2)或和后部植入物50相连而实现。
如果不打算进行后部修补,则按照需要进行简单的阴道切除术,其被限于阴道切口的边缘。随后通过连续的可吸收0号线将前部阴道切口关闭(如图3和7所示)直至阴道顶部,确认阴道壁不存在张力。
继续参阅图3和7,本领域技术人员可容易地理解:前部植入物10起修补外侧膀胱膨出以及内侧或中央性膀胱膨出的作用。还可以理解的是:前部植入物10的带42,44提供充分的侧向固定以排除将凸形侧边30,32缝或钉至盆筋膜腱弓(ATFP)的必要,从而避免非常困难并且耗时的缝合或钉的过程。
III. 后部修补
A. 会阴的切开
本过程在本领域内众所周知并且在附图中没有描绘,其包括两个基本步骤。这些步骤如下:(1)会阴皮肤的三角形切口和切除;和(2)会阴体的分离。
B. 阴道后壁的切开
自会阴切口纵向切开阴道后壁全层厚度至距阴道顶部2cm或至阴道顶部,从而产生一个适当大小的后部阴道切口。尽管本过程在附图中没有被描绘,但其在本领域中众所周知。
C. 直肠分离
将直肠的前壁和侧壁自阴道钝性分离。由于本过程已为本领域技术人员所熟知,其在附图中没有被描绘。
D. 直肠旁间隙分离
首先,经双侧轻度分离进入直肠旁间隙。随后更深地分离至骶棘韧带(Sacro-spinuous Iigament)被暴露或仅被触及。同样,尽管本过程在附图中没有被描绘,但其在本领域中众所周知。
E. 直肠前筋膜折叠术
本过程典型地使用2/0可吸收单丝线连续缝合而完成。因为本过程在本领域中众所周知,其在附图中亦未被描绘。
F. 后部植入物固定
参阅图6,图2的后部植入物50的侧面固定通过分别将不可吸收0号编织线(BS1)和(BS2)插入骶棘韧带(SS1)和(SS2)而完成,平均至患者身体两侧的坐骨棘2至3cm。分别将后部植入物50的带68,70和编织线(BS1)和(BS2)连接,所述植入物通过阴道口(VO)并且随后通过后部阴道切口(未显示)被插入患者体内。随后用所述编织线(BS1)和(BS2)将与它们相连的带68,70分别连接至骶棘韧带(SS1)和(SS2),从而后部植入物50如最佳图8中所描绘的那样被置于阴道(V)和直肠(R)之间。使用胶、钉、粗针、固定器(例如,MITEK的“Fastin”螺纹固定器或INFLUENCE的“Raz”软组织固定系统)或缝合装置如美国外科学会的“内缝合(Endostitch)”机械装置将带68,70连接至骶棘韧带(SS1)和(SS2)也是可能的。
现参阅图8,以及图3,后部植入物50的上方固定通过将上方部分54连接至没有任何固定的高位直肠的前壁而实现。或者,根据图3,后部植入物50的上方部分54可通过缝合或任何其它适宜的本领域中已知的方法被固定于子宫骶骨韧带(US1)和(US2);或,如果已经进行了前部修补,其可被折叠于阴道断端(VC)上并且随后在角24,26之间和前部植入物10的下方部分12相连。
继续参阅图3、8和9,后部植入物50的下方固定通过将所述植入物的下方部分52连接至中和低位直肠的前壁而实现。下方部分52的边74,76通过一或两针可吸收编织2/0线被固定于耻骨直肠肌(见图3和8)。为了治疗或预防相关的会阴下降,下方部分52的下方边缘72(即,游离边缘)被连接至会阴体(见图9)。
后部植入物50被适当地置于阴道(V)和直肠(R)之间时,后部修补则被完成。后方阴道切口(未显示)的关闭典型地通过自阴道顶部起的连续可吸收0号缝合而实现,确信后方阴道壁不存在张力。随后进行标准的会阴修复术覆盖后部植入物50的远端。
IV. 顶部修补
顶部固定可按照三种不同的方法而实现。以下将对各种方法进行描述。
按照方法一,阴道穹窿通过子宫骶骨韧带和前部植入物10和/或后部植入物50之间的连接而被固定(见图3)。如果子宫骶骨韧带仍然分离,则使用横向缝合,如果所述韧带被按照McCall式culdeplasty集中,则使用纵向缝合。
另一种方法涉及通过横跨固定的可吸收2/0编织线将阴道穹窿连接至前部植入物10和/或后部植入物50。和前面的方法一样,本方法使用植入物10,50之一或两者同时使用以完成所希望的顶部固定。
其它的顶部固定方法没有直接使用前部植入物10或后部植入物50。更具体地,阴道穹窿不依赖于植入物10,50而通过标准的双侧骶棘固定术被固定。
以下是前面所提及并且在图10和11中被描绘的两个备用实施方案的描述。在这些备用实施方案的描述中,同以上在图1和2的实施方案中所描述的元件相对应的元件可通过相应的参考数字加上100而被标明。除非另行说明,图10和11的备用实施方案分别用和图1和2的实施方案同样的方式进行建造和手术。
参阅图10,这里显示了前部植入物110,其与图1的前部植入物10相比的主要差异涉及前部植入物110的一侧上设有2两根带142并且前部植入物110的对侧上设有两根带144。两根带142均穿过患者一侧的闭孔,而两根带144均穿过患者身体的另一侧的闭孔。每根带142通过相应的身体一侧的会阴(即,腹股沟)上的两个小的皮肤切口之一穿出患者的身体。同样,每根带144通过相应的身体另一侧的会阴(即,腹股沟)上的两个小的皮肤切口之一穿出患者的身体。和前部植入物10相比,由于额外带有一套带142,144,前部植入物110在使用中可提供增强的侧面支持,它们的位置使得所生产的前部植入物110不带有前部植入物10所特有的角34,36和38,40。
参阅图11,这里显示了后部植入物150,其与图2的后部植入物50相比的主要差异涉及带168,170和后部植入物150的中央纵轴(L)形成的锐角。所述角度被特别地选定以便植入患者体内时在后部植入物150收缩的情况下减小直肠缩窄的量。
可以理解的是:这里所描述的各种实施方案仅仅作为示范并且本领域技术人员可进行更多的改变和修饰而不背离所附的权利要求中所定义的本发明的精神和范围。例如,如果子宫被保留(即,不进行子宫切除术),前部植入物10的后部固定在子宫颈的前部进行,同时后部植入物50的上方部分54被固定于子宫颈的后部。同样,一旦根据本发明完成脱垂修补,阴道切口可在中尿道水平被制造并且尿道下悬带根据众所周知的用于应激性尿失禁的疗法被插入。这些和任何所有其它改变和修饰被认为包括于如所附的权利要求中所定义的本发明的范围之内。

Claims (31)

1.用于治疗女性患者的中心性和外侧膀胱膨出的植入物(10;110),其特征为一个有中央纵轴(L)的体部(12,14;112,114)、一个所述中央纵轴贯穿的内侧区域(A1),所述内侧区域具有便于修补中心性膀胱膨出的大小和形状、至少一个位于所述内侧区域的至少一侧的外侧区域(A2和/或A3),所述的至少一个外侧区域具有便于修补外侧膀胱膨出的大小和形状,和用于不依赖患者的盆筋膜腱弓而在其两侧侧面稳定所述体部的稳定部件(42,44;142,144)。
2.根据权利要求1的植入物(10;110),其特征在于所述稳定部件包括至少一对自所述体部的相对的侧面向外侧延伸的带(42,44;142,144),每根所述带的长度足以穿过患者的相应的闭孔之一并且从在患者的会阴附近形成的相应的皮肤切口穿出。
3.根据权利要求2的植入物(10;110),其特征在于所述至少一对带包括自所述体部的一侧向外侧延伸的第一根带(42;142)和自所述体部的另一侧向外侧延伸的第二根带(44;144)。
4.根据权利要求3的植入物(10;110),其特征在于所述至少一个外侧区域包括在所述内侧区域(A1)的一侧的第一个外侧区域(A2)和在所述内侧区域(A1)的对侧的第二个外侧区域(A3)。
5.根据权利要求4的植入物(10;110),其特征在于所述体部包括一个大体的圆顶状部分(14;114),其具有作为所述第一外侧区域(A2)的至少一部分边界的第一外侧边(30;130)和作为所述第二外侧区域(A3)的至少一部分边界的第二外侧边(32;132)。
6.根据权利要求5的植入物(10;110),其特征在于所述第一根带(42;142)自所述圆顶状部分(14;114)的所述第一外侧边(30;130)向外侧延伸并且所述第二根带(44;144)自所述圆顶状部分(14;114)的所述第二外侧边(32;132)向外侧延伸。
7.根据权利要求6的植入物(10;110),其特征在于所述第一外侧边(30;130)为大体的凸形,其基本上和患者身体一侧的盆筋膜腱弓的形状相匹配并且所述第二外侧边(32;132)为大体的凸形,其基本上和患者身体另一侧的盆筋膜腱弓的形状相匹配。
8.根据权利要求7的植入物(10;110),其特征在于所述体部包括一个大体的漏斗形部分(12;112),其有一个在其宽边处汇入所述圆顶状部分(14;114)的宽部和自所述圆顶状部分的所述宽边向远处延伸的窄部,所述窄部呈便于使所述漏斗状部分(12;112)和患者的子宫骶骨韧带相连的大小和形状。
9.根据权利要求8的植入物(10;110),其特征在于,与所述圆顶状部分的所述宽边相对的所述圆顶状部分的一边包括一个凹形边缘(28;128),其汇入所述圆顶状部分(14;114)的所述第一和第二外侧边(30,32;130,132),所述凹形边缘(28;128)的大小和形状使其可以避免和患者的膀胱颈接触而又允许所述圆顶状部分(14;114)和患者的耻尾肌相连。
10.根据权利要求9的植入物(10),其特征在于所述第一根带(42)被置于所述圆顶状部分(14)的所述第一外侧边(30)的相对的末端(34,38)的中间并且所述第二根带(44)被置于所述圆顶状部分(14)的所述第二外侧边(32)的相对的末端(36,40)的中间。
11.根据权利要求9的植入物(110),其特征在于所述至少一对带包括第三根带(142),其沿所述圆顶状部分(114)的所述第一外侧边(130)自所述体部的所述一边向外侧延伸;和第四根带(144),其沿所述圆顶状部分(114)的所述第二外侧边(132)自所述体部的所述另一边向外侧延伸。
12.根据权利要求11的植入物(110),其特征在于所述第一和第二根带(142,144)被置于邻近所述圆顶状部分(114)的所述凹形边缘(128)处且所述第三和第四根带(142,144)被置于邻近所述圆顶状部分(114)的所述宽边处。
13.根据权利要求2的植入物(10;110),其特征在于所述体部(12,14;112,114)用单片生物相容性网状材料制成,因此所述至少一对带(42,44;142,144)和所述体部作为一体而形成。
14.根据权利要求1的植入物(10;110),其特征在于所述体部(12,14;112,114)和另一个适于治疗直肠膨出和/或子宫脱垂的植入物(50;150)作为一体而形成。
15.用于治疗女性患者的直肠膨出和子宫脱垂的植入物(50;150),其特征为一个有中央纵轴(L)的体部(52,54;152,154)、一个被所述中央纵轴(L)贯穿的大体的三角形部分(52;152),所述三角形部分(52;152)具有便于修补直肠膨出的大小和形状并且有沿所述中央纵轴(L)的一侧延伸的第一条边(74;174)和沿所述中央纵轴(L)的对侧延伸的第二条边(76;176)、和邻近所述三角形部分的宽边处的所述第一条边(74;174)连接并且从那里向外侧延伸的第一条带(68;168),以及和邻近所述三角形部分的所述宽边处的所述第二条边(76;176)连接并且从那里向外侧延伸的第二条带(70;170),所述第一和第二条带(68,70;168,170)和所述体部的中间部分(58;158)共同构成一个大小和形状便于进行阴道穹窿悬吊的大体的弓形带状部分。
16.根据权利要求15的植入物(50),其特征在于所述体部(52,54)包括用于将所述植入物(50;150)和适于治疗膀胱膨出的另一个植入物(10,110)连接的连接部件(54;154)。
17.根据权利要求16的植入物(50;150),其特征在于所述连接部件包括一个在其所述宽边处汇入所述三角形部分(52;152)的大体的长方形部分(54;154),其中,当沿着所述体部的所述中央纵轴(L)测量时,所述长方形部分(54;154)具有足以允许所述长方形部分(54;154)被折叠于患者的阴道断端上的尺寸。
18.根据权利要求15的植入物(50;150),其特征在于所述第一和第二根带(68,70;168,170)的长度足以连接至患者的骶棘韧带。
19.根据权利要求15的植入物(50;150),其特征在于所述第一和第二根带(68,70;168,170)的长度足以延伸穿过并且超出患者的骶棘韧带。
20.根据权利要求15的植入物(50;150),其特征在于所述体部(52,54;152,154)由单片生物相容性网状材料制成,由此所述第一和第二根带(68,70;168,170)和所述三角形部分(52;152)作为一体而形成。
21.根据权利要求15的植入物(50;150),其特征在于所述体部(52,54;152,154)和适于治疗膀胱膨出的另一个植入物(10;110)作为一体而形成。
22.根据权利要求15的植入物(150),其特征在于所述第一和第二根带(168,170)向着所述三角形部分(152)的所述宽边延伸并且超出所述宽边,和所述中央纵轴(L)形成一个锐角。
23.用于治疗女性患者的膀胱膨出的方法,其特征在于包括以下步骤:在患者的会阴邻近闭孔之一处制造一个第一皮肤切口;在患者的会阴邻近另一个闭孔处制造一个第二皮肤切口;提供具有至少一对向外延伸的带(42,44;142,144)的前部植入物(10;110);经患者的阴道口和阴道壁前部的切口将所述前部植入物(10;110)插入患者的骨盆区;将所述带之一(42;142)穿过所述的一个闭孔并且自所述第一皮肤切口穿出;将另一根所述带(44;144)穿过所述的另一个闭孔并且自所述第二皮肤切口穿出;并且拉紧所述一根带(42;142)和所述另一根带(44;144)直到所述前部植入物(10;110)被适当地放置于患者的膀胱和阴道之间以修补膀胱膨出。
24.根据权利要求23的方法,其特征在于还包括将所述前部植入物(10;110)和适于治疗直肠膨出和/或子宫脱垂的后部植入物(50;150)相连接的步骤。
25.根据权利要求24的方法,其特征在于所述前部(10;110)和后部(50;150)植入物在其引入患者体内后被相互连接。
26.根据权利要求24的方法,其特征在于所述前部(10;110)和后部(50;150)植入物在其引入患者体内前被相互连接。
27.用于治疗女性患者的直肠膨出和子宫脱垂的方法,其特征在于包括以下步骤:提供一个带有一对向侧面延伸的带(68,70;168,170)的后部植入物(50;150);将所述后部植入物(50;150)经患者的阴道口和阴道壁后部的切口插入患者的骨盆区;将所述后部植入物(50;150)置于患者的直肠和阴道之间以修补直肠膨出;将所述带之一(68;168)和患者的骶棘韧带之一相连;并且将另一根所述带(70;170)和患者的另一个骶棘韧带相连,从而修补患者的子宫脱垂。
28.根据权利要求27的方法,其特征在于还包括将所述后部植入物(50;150)和适于修补膀胱膨出的前部植入物(10;110)相连接的步骤。
29.根据权利要求28的方法,其特征在于所述前部(10;110)和后部(50;150)植入物在其引入患者体内后被相互连接。
30.根据权利要求28的方法,其特征在于所述前部(10;110)和后部(50;150)植入物在其引入患者体内前被相互连接。
31.根据权利要求27的方法,其特征在于所述一根带(68;168)延伸穿过并且超出其相关的骶棘韧带并且所述另一根带(70;170)延伸穿过并且超出其相关的骶棘韧带。
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CN105769380A (zh) * 2016-05-30 2016-07-20 周建 骨盆腔内膀胱底外支架和植入方法
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