WO2019109776A1 - 一种微创舒适性尿失禁吊带装置及其应用 - Google Patents

一种微创舒适性尿失禁吊带装置及其应用 Download PDF

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Publication number
WO2019109776A1
WO2019109776A1 PCT/CN2018/114752 CN2018114752W WO2019109776A1 WO 2019109776 A1 WO2019109776 A1 WO 2019109776A1 CN 2018114752 W CN2018114752 W CN 2018114752W WO 2019109776 A1 WO2019109776 A1 WO 2019109776A1
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WIPO (PCT)
Prior art keywords
sling
surgical mesh
urinary incontinence
minimally invasive
fascia
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PCT/CN2018/114752
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English (en)
French (fr)
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李建民
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苏州优迈医疗器械有限公司
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Publication of WO2019109776A1 publication Critical patent/WO2019109776A1/zh

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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
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament

Definitions

  • the invention belongs to a surgical instrument, in particular to a portable device for performing tension adjustment and locking of a surgical mesh belt after implantation of a surgical mesh belt for treating stress urinary incontinence and an application thereof.
  • Female urinary incontinence is a common disease in women. According to global statistics, the prevalence rate is close to 50%, and about half of them are Stress Urinary Incontinence (SUI). Stress urinary incontinence means that when the bladder pressure is greater than the maximum urethral pressure, in the absence of contraction of the bladder detrusor, the urine also involuntarily overflows from the external urethra, especially when the abdominal pressure suddenly increases, such as: laughing, sneezing, Coughing occurs at the same time. Postmenopausal populations are more susceptible to morbidity. Most of the causes of the disease are due to birth injury during childbirth, estrogen levels after menopause, and soft tissue relaxation at the pelvic floor.
  • SUI began to be considered one of the top five diseases affecting human health in the mid-1990s and is known as "social cancer.” Especially in China, with the further aging of the population, SUI has received more and more attention.
  • a group of foreigners reported 37.7% of women with urinary incontinence over 60 years of age. To this end, the search for effective methods for treating SUI has urgent and significant clinical significance.
  • Tension-free vaginal tape is the gold standard for SUI treatment in surgical treatment.
  • TVT is considered to have a high cure rate, simple operation, small trauma, rapid postoperative recovery, few complications, and low recurrence rate, and is widely used in clinical practice.
  • the sling of the surgical method needs to be cut and discarded, so the amount and waste of the sling is very large.
  • SIS transvaginal tension-free urethral suspension
  • the surgical mesh belt with closed-end anchors at both ends is used to position the closed-hole anchors on the corresponding closed-cell fascia, and the tension and position of the surgical mesh belt can be adjusted appropriately to complete the operation.
  • the operation time is greatly reduced and the wound is wounded. Healing faster.
  • due to the limited width of the incision in the current surgical procedure the difficulty in the implantation of the obturator anchor in the obturator fascia is overcome, and the adjustment of the tension of the surgical mesh belt and the locking of the positioning become the surgery of the relevant physician.
  • the extremely painful steps, and the equipment required to use the operation is cumbersome.
  • the technical solution for achieving the above object of the present invention is a minimally invasive comfort urinary incontinence sling device, characterized in that the sling device is composed of a locking anchor, a surgical mesh sling and a puncture assembly, wherein the locking anchor Only one and fixed to the directional end of the surgical mesh sling, the locking anchor is fixed on one side of the posterior pubic tissue or the obturator fascia, and the free end of the surgical mesh sling extending from the other side of the directional end passes
  • the puncture component is adjustable in tension and is placed in the microperforation of the abdominal wall and the inner side of the thigh or the outwardly facing periphery of the obturator fascia.
  • the surgical mesh sling is a mid-length sling having a length between the length of the single-cut sling and the length of the tension-free pubic sling.
  • the length of the surgical mesh sling is between 7.5 cm and 30 cm.
  • the length of the surgical mesh sling is between 9 cm and 23 cm.
  • the surgical net sling is a finished product that is customized at one time according to the length specification, or an improved product that fixes the locking anchor at one end of the closed-loop tension-free sling.
  • the technical solution of the present invention to achieve the above other object is an application of a minimally invasive comfort urinary incontinence sling device, characterized in that the device is applied to a single incision for the treatment of urinary incontinence sling implants in patients with hip joint dysfunction Single-hole surgery, in which the directional end of the surgical mesh sling is fixed to the pubic surrounding tissue by a single-incision sling implantation, and the free end of the surgical mesh sling is adjusted by tensioning through the vaginal urethral suspension and is fixed to the other.
  • the locking anchor is fixed on one side of the obturator fascia, and the free end of the surgical mesh sling penetrates the obturator fascia of the other side through the urethral bottom side and Inside the thigh, adjust the tension of the surgical mesh strap and fix it in the micro-perforations on the inside of the thigh.
  • the locking anchor is fixed on one side of the obturator fascia, and the free end of the surgical mesh sling passes through the urethral bottom side and penetrates the posterior pubic fascia from the posterior pubis And the patient wears the lower abdomen, adjusts the tension of the surgical mesh strap and fixes it in the micro-perforation of the abdominal wall.
  • the locking anchor is fixed on one side of the retropubic fascia, and the free end of the surgical mesh sling passes through the urethral bottom side and penetrates the retropubic fascia from the posterior pubic symphysis
  • the layer is worn by the patient's lower abdomen, and the tension of the surgical mesh strap is adjusted and fixed in the microperforation of the abdominal wall.
  • the locking anchor is fixed on one side of the retropubic fascia, and the free end of the surgical mesh sling passes through the urethral bottom side and penetrates the retropubic fascia from the posterior pubic symphysis
  • the layer is placed by the patient's lower abdomen through a surgical line connected to the surgical mesh sling, and the tension of the surgical mesh sling is adjusted and fixed in the posterior pubic fascia.
  • the minimally invasive comfort urinary incontinence sling device of the present invention is applied to a sling implantation operation, which has the advantages of simple structure and easy one-hand operation, reducing the trauma of the patient's multiple incisions and reducing the traditional TVT surgical sling
  • the dosage is large, and at the same time overcomes the problems of inconvenient adjustment, difficulty, and postoperative leg pain of the traditional SIS surgical strap tension.
  • FIG. 1 is a schematic view showing the structure and surgical application of the minimally invasive comfort urinary incontinence sling device of the present invention.
  • Figure 2 is a schematic illustration of another surgical application of the device of the present invention.
  • Figure 3 is a schematic view of another surgical application of the device of the present invention.
  • Figure 4 is a schematic illustration of another surgical application of the device of the present invention.
  • the designer of the present invention has conducted in-depth research on the traditional surgical sling implant device for treating stress urinary incontinence and its operation and use method, and has developed a minimally invasive and comfortable urinary incontinence sling device and its application, thereby solving the current problem.
  • Surgical mesh sling implanted instruments and their surgical problems are inadequate.
  • the minimally invasive comfort urinary incontinence sling device is comprised of a locking anchor 5, a surgical mesh sling 6 and a piercing assembly (not shown), wherein the locking anchor 5 requires only one use in the device. And fixed to the directional end of the surgical mesh sling 6.
  • the term "directional end" as used herein refers to the other side on which the tension adjustment of the sling occurs, or the other side of the unilateral movement disorder of the patient's body, relative to the surgeon's ease of operation.
  • the surgical mesh sling 6 is a mid-length sling of length between the length of the single-cut sling (SIS) and the length of the tension-free closed-hole sling (TVT-O).
  • the directional end of the surgical mesh sling 6 is fixed to the pubic surrounding tissue on one side, and the left obturator fascia 42 is visible in the present embodiment from the illustration.
  • the free end of the surgical mesh sling 6 is passed through the right side of the urethral fascia 41 through the puncture component (not shown), and is passed out from the inside of the patient's thigh, and the surgical mesh 7 is adjusted to the appropriate degree by the surgical line 7.
  • the posterior positioning is fixed in the microperforations on the inner side of the thigh.
  • the device of the present invention only needs to open a mouth on the upper wall of the vagina in the surgical operation, and then perform a puncture on the abdominal wall as needed, that is, a single incision plus a single hole.
  • the above surgical mesh harness can also be named as "1.5 incision strap” or TVT hybrid harness, TVT-C and the like.
  • the surgical mesh sling can be a one-time customized product according to the length specification, or an improved product of the locking anchor at one end of the closed-loop tension-free sling.
  • the length of the surgical mesh sling is 7.5cm - 30cm, and the recommended length for clinical application is 9cm-23cm.
  • the length of the surgical mesh sling after the implantation of the other side of the obturator fascia is less than 9 cm in the operation of the soft tissue compression force (TVT-A). It is more suitable and easy to use, and when applied to single-side micro-perforation positioning surgery (TVT-O), the length of the surgical mesh sling is suitable for selection within 23 cm.
  • the length of the surgical mesh sling can also be limited to the right obturator fascia, without passing through the right thigh muscle, that is, the 9.5 cm length of the surgical mesh sling can meet the TVT-A surgery Application, which can effectively reduce leg muscle pain that may occur after surgery.
  • the minimally invasive comfort urinary incontinence sling device of the present invention concentrates on the clinical advantages of a tension-free retropubic sling (TVT), a tension-free meniscus sling (TVT-O) and a single-slit sling (SIS), while avoiding any of the above
  • the disadvantages of a single method The surgical mesh sling is fixed to the obturator fascia by a single-incision sling with a fixed anchor on one side, and the tension-free pubic sling implantation (TVT) or conventional transobturator sling is still used on the other side.
  • the surgical mesh sling can be pulled by the puncture assembly (or replaced with a surgical line or other traction tool) and passed through the pubic surrounding tissue (or obturator fascia) and from The lower abdomen or the inner thigh is worn out, and the tension of the surgical mesh sling can be effectively fixed by the closed fascia and the surrounding soft tissue under the action of the pressing force. Since most doctors use the right hand as the main operation hand, in this embodiment as shown in FIG. 1 , the device is fixed, and the fixed anchor of the directional end of the surgical mesh strap is set on the left side of the patient. On the right side of the patient, the puncture of the obturator fascia and the fixation of the surgical mesh sling are easier for the physician to operate in the opposite direction.
  • the device of the present invention is not limited by the habit of the right and left hands.
  • the pre-installation direction of the anchor of the directional end can be changed according to the doctor's hand.
  • the application of the minimally invasive comfort urinary incontinence sling device of the present invention in 1.5 incision surgery can also have many feasible embodiments, and the two examples of right-hand operation are as follows.
  • the surgical net sling is an improved product of a fixed locking anchor at one end of a conventional closed-cell tension-free sling.
  • the locking anchor 5 is first fixed in the posterior pubic fascia 2 by a special tool such as a puncture handle, and the other end of the surgical mesh sling 6 passes through the bottom side of the urethra 3 and punctures in a conventional TVT operation.
  • the "bone" (close to the patient's right pubic wall), after passing through the posterior pubic fascia 2, is passed through the abdominal wall 1 of the patient's lower abdomen to form an implant-like shape resembling a mirror-shaped J-shape.
  • the surgical net sling is also an improved product of a fixed locking anchor at one end of a conventional closed-cell tension-free sling.
  • the locking anchor 5 is first fixed in the obturator fascia 42 by a special tool such as a puncture handle, and the other end of the surgical mesh sling 6 is passed through the bottom side of the urethra 3 by a conventional TVT surgical procedure.
  • the ossicles (close to the pubic wall of the patient's right side), after passing through the posterior pubic fascia 2, are passed through the abdominal wall 1 of the patient's lower abdomen to form an L-shaped implant shape.
  • the surgical net sling is a finished product (single-cut sling) that is customized at one time according to the length specification.
  • the locking anchor 5 fixed at one end of the surgical mesh sling 6 is fixed in the posterior pubic fascia 2 by a special tool such as a puncture handle, and the other end of the surgical mesh sling 6 is connected for tension adjustment.
  • Surgical line, and the traditional TVT surgery through the urethra 3 bottom side puncture "bone” (close to the patient's right pubic wall), and then through the retropubic fascia 2, only the surgical line 7 from the patient's lower abdomen
  • the abdominal wall 1 is pierced to form a U-shaped implant shape.
  • the minimally invasive comfort urinary incontinence sling device of the present invention is superior to the clinical application of the tensionless retropubic sling (TVT) and the single incision sling (SIS), and, for a unilateral hip joint
  • TVT tensionless retropubic sling
  • SIS single incision sling
  • 1.5-incision sling and its surgical approach also have significant application and practicality.
  • the utility model has the advantages that the device is simple in structure and easy to be operated by one hand, thereby reducing the trauma caused by multiple incisions of the patient.

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Abstract

一种微创舒适性尿失禁吊带装置及其应用，由锁定锚钉（5）、手术网吊带（6）和穿刺组件构成，手术网吊带（6）的定向端通过锁定锚钉（5）实现单切口吊带的固定和植入方式，而手术网吊带（6）的自由端通过穿刺组件实现经闭孔吊带的固定和植入方式；其中定向端固定于一侧耻骨后的周边组织或左侧闭孔筋膜（42）上，自由端通过穿刺组件穿接并定位于腹壁（1）及大腿内侧的微穿孔中或右侧闭孔筋膜（41）上。微创舒适性尿失禁吊带装置应用于吊带植入手术，其优点为微创舒适性尿失禁吊带装置结构简单且易于单手操作，减轻了患者多切口所带来的创伤感，减少了传统TVT手术吊带用量大、同时克服了传统SIS手术吊带张力调节不便、难度大、TOT术后腿疼痛等问题。

Description

一种微创舒适性尿失禁吊带装置及其应用 技术领域
本发明属于外科手术器械，具体涉及一种用于治疗压力性尿失禁的手术网带植入后进行手术网带张力调节和锁固的便用型装置及其应用。
背景技术
女性尿失禁是女性常见病，目前据全球统计，患病率接近50％，其中约一半为压力性尿失禁(Stress Urinary Incontinence，SUI)。压力性尿失禁是指膀胱压大于最大尿道压时，在无膀胱逼尿肌收缩的状态下，尿液也不由自主地由尿道外口溢出，多在腹压突然增加时例如：大笑、喷嚏、咳嗽等时发生。绝经后人群更易发病。发病原因多数因为分娩时产伤，绝经后雌激素水平下降，盆底软组织松弛等。SUI在90年代中期开始被认为是影响人类健康的五大疾病之一，被称为“社交癌”。特别是在我国，随着人口进一步老龄化，SUI越来越受到人们的重视。最近一项单纯北京地区尿失禁发病率调查发现，女性人群中23％-45％有不同程度的尿失禁，7％左右有明显的尿失禁症状，其中约50％为压力性尿失禁。国外一组报道60岁以上尿失禁发病率女性37.7％。为此，寻求有效的治疗SUI的方法，具有迫切的、重大的临床意义。
在手术治疗中无张力经阴道尿道中段悬吊术(Tension-free vaginal tape，TVT)是SUI治疗的金标准。目前认为TVT治愈率高、操作简便、创伤小、术后恢复快、并发症少、复发率低等优点并在临床上得到广泛应用。但该手术方法的吊带需要裁剪遗弃，因此吊带用量和浪费甚巨。近年来，为减少创伤面，一种单切口经阴道无张力尿道中段悬吊术(SIS)便应运而生并实践性地日渐成熟。采用两端连接闭孔锚的手术网带，将闭孔锚分两侧先后定位于对应的闭孔筋膜上，并适度调节手术网带张力和位置即可完成手术，手术时间大幅降低且创伤愈合速度较快。而现有此类手术过程中由于切口幅面有限，在闭孔锚植入定位在闭孔筋膜的难度被克服基础上，对于手术网带张力的调节和定位锁死成为了相关医师进行手术时所极为头疼的步骤，而所需用到的器械操作繁琐。即在可视条件较差的情况手术网带张力调节 不便，而且当手术网带张力调节合适情况下进行定位锁结时造成的张力变化幅度较大，且同时存在因张力调节失当造成闭孔筋膜撕裂，固定锚钉脱落等风险，不适于医师高效而可靠地完成此类手术。
发明内容
鉴于上述现有技术的缺陷，本发明的目的旨在提出一种微创舒适性尿失禁吊带装置及其应用。
本发明实现上述一个目的的技术解决方案是，一种微创舒适性尿失禁吊带装置，其特征在于：所述吊带装置由锁定锚钉、手术网吊带和穿刺组件构成，其中所述锁定锚钉仅一个且固接于手术网吊带的定向端，所述锁定锚钉固定于一侧耻骨后的周边组织或闭孔筋膜上，所述手术网吊带相对定向端另一侧延伸的自由端通过穿刺组件张力可调并穿接定位于腹壁及大腿内侧的微穿孔中或闭孔筋膜外向周边。
进一步地，所述手术网吊带为长度介于单切口吊带长度和无张力耻骨后吊带长度之间的中长型吊带。
进一步地，所述手术网吊带的长度介于7.5cm-30cm。
更进一步地，所述手术网吊带的长度介于9cm-23cm。
进一步地，所述手术网吊带为根据长度规格一次性定制的成品，或为经闭孔无张力吊带一端固接锁定锚钉的改良品。
本发明实现上述另一个目的的技术解决方案是，一种微创舒适性尿失禁吊带装置的应用，其特征在于：所述装置应用于髋关节活动障碍患者治疗尿失禁吊带植入的单切口加单孔手术，其中手术网吊带的定向端通过单切口吊带植入方式固定于一侧耻骨周边组织，手术网吊带的自由端通过经阴道尿道中段悬吊植入方式调节张力并穿接固定于另一侧耻骨周边组织及微穿孔中。
进一步地，单切口加单孔手术中，所述锁定锚钉固定于一侧的闭孔筋膜上，所述手术网吊带的自由端经尿道底侧穿透另一侧的闭孔筋膜和大腿内侧，调节手术网吊带张力并固定于大腿内侧的微穿孔中。
进一步地，单切口加单孔手术中，所述锁定锚钉固定于一侧的闭孔筋膜上，所述手术网 吊带的自由端经尿道底侧、从耻骨后穿透耻骨后筋膜层，并由患者小腹穿出，调节手术网吊带张力并固定于腹壁微穿孔中。
进一步地，单切口加单孔手术中，所述锁定锚钉固定于一侧的耻骨后筋膜层上，所述手术网吊带的自由端经尿道底侧、从耻骨后穿透耻骨后筋膜层，并由患者小腹穿出，调节手术网吊带张力并固定于腹壁微穿孔中。
进一步地，单切口加单孔手术中，所述锁定锚钉固定于一侧的耻骨后筋膜层上，所述手术网吊带的自由端经尿道底侧、从耻骨后穿透耻骨后筋膜层，并由患者小腹穿出与手术网吊带牵引相连的手术线，调节手术网吊带张力并固定于耻骨后筋膜层中。
应用本发明的微创舒适性尿失禁吊带装置于吊带植入手术，其优点是：该装置结构简单且易于单手操作，减轻了患者多切口所带来的创伤感，减少了传统TVT手术吊带用量大、同时克服了传统SIS手术吊带张力调节不便、难度大、术后腿疼痛等问题。
附图说明
图1是本发明微创舒适性尿失禁吊带装置的结构及其手术应用示意图。
图2是本发明装置另一手术应用示意图。
图3是本发明装置再一手术应用示意图。
图4是本发明装置又一手术应用示意图。
具体实施方式
以下便结合实施例附图，对本发明的具体实施方式作进一步的详述，以使本发明技术方案更易于理解、掌握，从而对本发明的保护范围做出更为清晰的界定。
本发明设计者针对传统治疗压力性尿失禁的手术网吊带植入器械及其操作使用方法进行了深入研究，开拓思路创新提出了一种微创舒适性尿失禁吊带装置及其应用，从而解决当前手术网吊带植入器械及其手术多方面不足的问题。
如图1所示，是本发明微创舒适性尿失禁吊带装置的结构及其手术应用示意图。作为一个优选实施例，该微创舒适性尿失禁吊带装置由锁定锚钉5、手术网吊带6和穿刺组件(未图示)构成，其中该锁定锚钉5在本装置中仅需使用一个，且固接于手术网吊带6的定向 端。这里所谓定向端，指的是相对手术操作的医师顺手性而言，吊带张力调节发生所在的另一侧，或者患者躯体单侧活动障碍的另侧。另外，该手术网吊带6为长度介于单切口吊带(SIS)长度和无张力经闭孔吊带(TVT-O)长度之间的中长型吊带。该手术网吊带6的定向端固定于一侧耻骨周边组织，从图示可见本实施例中为左侧闭孔筋膜42。而且手术网吊带6的自由端通过穿刺组件(未图示)经尿道底侧穿接右侧闭孔筋膜41，并从患者大腿内侧穿出，以手术线7调节手术网吊带张力至合适程度后定位固定于大腿内侧的微穿孔中。从手术分类上而言，本发明装置在手术操作上仅需要在阴道上壁开设一切口，并随之按需在腹壁实施穿刺，也就是单切口加单孔的手术。可理解为1.5切口的手术方式，与之对应地，上述手术网吊带也可命名为“1.5切口吊带”或TVT混合吊带，TVT-C等。而且，从应用角度来看，该手术网吊带可以是根据长度规格一次性定制的成品，也可以是经闭孔无张力吊带一端固接锁定锚钉的改良品。从长度规格来看，该手术网吊带的长度为7.5cm–30cm，临床应用的建议长度为9cm-23cm。而据本发明设计者的进一步研制和试验，该手术网吊带在植入另一侧闭孔筋膜后余留小段由软组织挤压力固定的手术(TVT-A)中的长度为9cm左右时较为合适、易用，而当应用于单侧穿出微穿孔定位手术(TVT-O)时手术网吊带的长度则适于选用23cm以内为宜。
上述实施例的手术描述，手术网吊带的长度也可以以穿过右侧闭孔筋膜为限，而不穿过右侧大腿肌肉，即9.5cm长度的手术网吊带即可满足TVT-A手术应用，从而能有效降低术后可能发生的腿部肌肉疼痛。
此外，需要说明的是，上述穿刺组件在当前TVT手术中被广泛应用，具有较大器材范围的可选性，本领域技术人员及医师均熟知，故省略图示和具体描述及限定。而为了便于图示仅用非规则手术线替代，实际使用时具有更具体、更强操作易用性的器械可选。
本发明该微创舒适性尿失禁吊带装置集中了无张力耻骨后吊带(TVT)，无张力经闭孔吊带(TVT-O)和单切口吊带(SIS)的临床优点，又同时避免了以上任何单个方法的缺点。一侧采用固定锚钉通过单切口吊带植入方式将手术网吊带固定于闭孔筋膜上，而另一侧仍旧采用无张力耻骨后吊带植入方式(TVT)或传统经闭孔吊带植入方式(TVT-O)，在张力调节完成后手术网吊带可以由穿刺组件(或用手术线或其它牵引工具替代)将手术网吊带拉入并 通过耻骨周边组织(或闭孔筋膜)并从小腹或大腿内侧穿出，而手术网吊带的张力可由闭孔筋膜及其周围的软组织在挤压力作用下被有效固定。由于绝大多数医师都是以右手为主要操作手的，为此如图1所示的本实施例中该装置在手术中，手术网吊带定向端的固定锚钉被设在病人的左侧，而病人的右侧则穿刺闭孔筋膜引出并固定手术网吊带更易于医师的对向操作。
然而本发明该装置并非受左右手习惯的限制，在具体手术操作过程中，可以根据医师顺手情况改变定向端固定锚钉的预装方向即可。
除上述实施例外，本发明该微创舒适性尿失禁吊带装置在1.5切口手术中的应用还可以有诸多可行的实施方式，均已右手操作举例两项如下。
另一较佳实施例：如图2所示，本实施例中该手术网吊带则为传统经闭孔无张力吊带一端固接锁定锚钉的改良品。在手术作业过程中，先将锁定锚钉5通过穿刺手柄等专用工具固定于耻骨后筋膜层2之中，而手术网吊带6另一端则以传统TVT的手术方式经过尿道3底侧、穿刺“抱骨”(紧贴病人的右侧耻骨壁)、再经过耻骨后筋膜层2后由患者小腹的腹壁1穿出，形成类似镜像J字形的植入形状。当然，在完成手术网吊带的穿刺通过后还需要调节手术网吊带所需的张力，以便利用耻骨周边组织和腹壁组织的挤压力将其固定于腹壁的微穿孔中。
再一较佳实施例：如图3所示，本实施例中该手术网吊带同样为传统经闭孔无张力吊带一端固接锁定锚钉的改良品。在手术作业过程中，先将锁定锚钉5通过穿刺手柄等专用工具固定于闭孔筋膜42之中，而手术网吊带6另一端则以传统TVT的手术方式经过尿道3底侧、穿刺“抱骨”(紧贴病人的右侧耻骨壁)、再经过耻骨后筋膜层2后由患者小腹的腹壁1穿出，形成类似L字形的植入形状。当然，在完成手术网吊带的穿刺通过后也需要调节手术网吊带所需的张力，以便利用耻骨周边组织和腹壁组织的挤压力将其固定于腹壁的微穿孔中。
又一较佳实施例：如图4所示，本实施例中该手术网吊带为根据长度规格一次性定制的成品(单切口吊带)。在手术作业过程中，先将手术网吊带6一端固连的锁定锚钉5通过穿刺手柄等专用工具固定于耻骨后筋膜层2之中，而手术网吊带6另一端则连接张力调节用的 手术线，并以传统TVT的手术方式经过尿道3底侧、穿刺“抱骨”(紧贴病人的右侧耻骨壁)、再经过耻骨后筋膜层2后，仅将手术线7由患者小腹的腹壁1穿出，形成类似U字形的植入形状。当然，在完成手术线7的穿刺通过后也需要调节手术网吊带所需的张力，并利用耻骨周边组织的挤压力将其固定于耻骨后筋膜层2中。
以上多个实施例的详细介绍可见，本发明该微创舒适性尿失禁吊带装置优于无张力耻骨后吊带(TVT)和单切口吊带(SIS)的临床应用，而且，对于有单侧髋关节活动障碍的患者，该1.5切口吊带及其手术方式同样具有显著的应用及实用性。
综上关于本发明拉结式调锁装置实施例的详细描述可见，其应用于吊带植入手术，其优点是：该装置结构简单且易于单手操作，减轻了患者多切口所带来的创伤感，减少了传统TVT手术吊带用量大、同时克服了传统SIS手术吊带张力调节不便、难度大、术后腿疼痛等问题。

Claims (10)

  1. 一种微创舒适性尿失禁吊带装置，其特征在于：所述吊带装置由锁定锚钉、手术网吊带和穿刺组件构成，其中所述锁定锚钉仅一个且固接于手术网吊带的定向端，所述锁定锚钉固定于一侧耻骨后的周边组织或闭孔筋膜上，所述手术网吊带相对定向端另一侧延伸的自由端通过穿刺组件张力可调并穿接定位于腹壁及大腿内侧的微穿孔中或闭孔筋膜外向周边。
  2. 根据权利要求1所述微创舒适性尿失禁吊带装置，其特征在于：所述手术网吊带为长度介于单切口吊带长度和无张力耻骨后吊带长度之间的中长型吊带。
  3. 根据权利要求1或2所述微创舒适性尿失禁吊带装置，其特征在于：所述手术网吊带的长度介于7.5cm-30cm。
  4. 根据权利要求3所述微创舒适性尿失禁吊带装置，其特征在于：所述手术网吊带的长度介于9cm-23cm。
  5. 根据权利要求1所述微创舒适性尿失禁吊带装置，其特征在于：所述手术网吊带为根据长度规格一次性定制的成品，或为经闭孔无张力吊带一端固接锁定锚钉的改良品。
  6. 一种微创舒适性尿失禁吊带装置的应用，其特征在于：所述装置应用于髋关节活动障碍患者治疗尿失禁吊带植入的单切口加单孔手术，其中手术网吊带的定向端通过单切口吊带植入方式固定于一侧耻骨周边组织，手术网吊带的自由端通过经阴道尿道中段悬吊植入方式调节张力并穿接固定于另一侧耻骨周边组织及微穿孔中。
  7. 根据权利要求6所述微创舒适性尿失禁吊带装置的应用，其特征在于：单切口加单孔手术中，所述锁定锚钉固定于一侧的闭孔筋膜上，所述手术网吊带的自由端经尿道底侧穿透另一侧的闭孔筋膜和大腿内侧，调节手术网吊带张力并固定于大腿内侧的微穿孔中。
  8. 根据权利要求6所述微创舒适性尿失禁吊带装置的应用，其特征在于：单切口加单孔手术中，所述锁定锚钉固定于一侧的闭孔筋膜上，所述手术网吊带的自由端经尿道底侧、从耻骨后穿透耻骨后筋膜层，并由患者小腹穿出，调节手术网吊带张力并固定于腹壁的微穿孔中。
  9. 根据权利要求6所述微创舒适性尿失禁吊带装置的应用，其特征在于：单切口加单孔手术中，所述锁定锚钉固定于一侧的耻骨后筋膜层上，所述手术网吊带的自由端经尿道底侧、从耻骨后穿透耻骨后筋膜层，并由患者小腹穿出，调节手术网吊带张力并固定于腹壁的微穿 孔中。
  10. 根据权利要求6所述微创舒适性尿失禁吊带装置的应用，其特征在于：单切口加单孔手术中，所述锁定锚钉固定于一侧的耻骨后筋膜层上，所述手术网吊带的自由端经尿道底侧、从耻骨后穿透耻骨后筋膜层，并由患者小腹穿出与手术网吊带牵引相连的手术线，调节手术网吊带张力并固定于耻骨后筋膜层中。
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