WO2015010391A1 - 限制接触型侧球囊双孔导尿管 - Google Patents

限制接触型侧球囊双孔导尿管 Download PDF

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Publication number
WO2015010391A1
WO2015010391A1 PCT/CN2013/086922 CN2013086922W WO2015010391A1 WO 2015010391 A1 WO2015010391 A1 WO 2015010391A1 CN 2013086922 W CN2013086922 W CN 2013086922W WO 2015010391 A1 WO2015010391 A1 WO 2015010391A1
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Prior art keywords
balloon
hole
drainage
lumen
chamber
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PCT/CN2013/086922
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English (en)
French (fr)
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王亮
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Individual
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Individual
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Priority to US14/762,404 priority Critical patent/US20150352339A1/en
Priority to JP2016528296A priority patent/JP2016527013A/ja
Priority to EP13890218.4A priority patent/EP2932996A4/en
Publication of WO2015010391A1 publication Critical patent/WO2015010391A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0155—Tip steering devices with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/225—Flush valves, i.e. bypass valves for flushing line
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape

Definitions

  • the invention relates to a contact-type side balloon double-hole urinary catheter, which belongs to the technical field of medical auxiliary devices.
  • a urinary catheter is a commonly used medical aid that can be inserted into the bladder through the patient's urethra to direct the flow of urine. After the catheter is inserted into the bladder, there is a balloon near the head of the catheter to hold the catheter in the bladder without being easily released. The drainage portion of the catheter is connected to the urine bag to collect urine.
  • urinary tract infections are urinary tract infections, poor drainage, difficulty in extubation, bladder spasm or contracture, but the most common complication is urinary tract infection.
  • the bladder triangle is a good site for tumors, tuberculosis and inflammation. It is a key area for cystoscopy and has important clinical significance.
  • the object of the present invention is to overcome the existing balloon three-cavity catheter into the body, after the urine needs to be inserted about 3cm, in order to inject water or inflate, there is a gap between the drainage tube of the balloon catheter and the bottom of the bladder. 3-5cm distance, and a balloon at intervals, there is always some urine remaining in the bottom of the bladder, breeding bacteria, inflammation, formation of stones, causing leakage of urine; balloon wall continues to stimulate the bladder triangle, induce inflammation, patients have frequent urination Defects such as urgency, discomfort in the lower abdomen, etc., provide a two-hole catheter that restricts the contact-type side balloon.
  • the urine can be filled or inflated, not only firmly fixed, but also not prolapsed. Moreover, it does not cause irritation to the bladder triangle, no urine residue, no bladder irritation, no leakage of urine, and resolves various complications of the existing balloon catheter.
  • a contact-type side balloon double-hole urinary catheter including a tube body, a tip end, a side balloon, a balloon chamber, a drainage chamber drainage upper hole, a drainage chamber, and a passage Balloon infusion or insufflation lumen, drainage lumen drainage lower hole, through balloon infusion or infusion lumen through balloon orifice, irrigation lumen, irrigation lumen drainage orifice, balloon infusion or insufflation anti-reverse flow valve, drainage lumen
  • the tapered interface, the flushing chamber tapered interface, and the flushing chamber clamping switch are characterized in that: the tubular body is made of a polymer blend, and the side balloon of the catheter is placed near the tip end.
  • One side of the tubular body, the opposite side of the tubular body of the side balloon of the urinary catheter has a drainage chamber draining the lower hole near the bottom of the balloon, and a drainage chamber draining the upper hole near the top of the balloon, the irrigation lumen a liquid outlet hole is disposed at the tip end, and the side tube slope is located on the side of the drainage lumen drainage hole and the plane formed by the balloon injection or the gas injection lumen through the balloon hole, the guide How to use the urinary tube, see the urine to fill or inflate,
  • the side balloon of the catheter placed behind the bladder is automatically tilted to one side in the state of water injection or insufflation, and the frame space composed of the inclined side balloon and the catheter and the bottom of the bladder wall is sufficient to accommodate the bladder triangle, the balloon
  • the wall and the tube body are not in contact with or slightly contacted with the bladder triangle, and the catheter can be continuously fixed in the bladder without prolapse.
  • the side balloon of the catheter placed behind the bladder is not in the state of water injection or gas injection.
  • the bladder triangle is compressed, and the ureteral orifice is not pressed.
  • the lateral balloon placed behind the bladder is in a state of water injection or insufflation, and the lower hole of the drainage lumen is adjacent to the ureteral orifice.
  • Normal urine and abnormal urine in the bladder Liquid, timely emptying, no residual in the bladder, the tip of the catheter, the side balloon, the balloon cavity, the drainage cavity drainage hole, the drainage cavity, the balloon injection or the infusion lumen, the drainage cavity drainage Lower hole, through balloon infusion or insufflation lumen through balloon, irrigation lumen, irrigation lumen outlet, balloon infusion or insufflation anti-backflow valve, drainage chamber tapered interface, irrigation chamber tapered interface, flush Cavity clip switch Through the tube together into a whole piece.
  • the side balloon placed behind the bladder is in a state of water injection or injecting, and the lower hole of the drainage lumen is adjacent to the ureteral orifice, and the bladder can be completely absorbed by adsorption, negative pressure, siphon, etc.
  • the normal urine and abnormal urine in the urine are drained into the body without residue.
  • the tubular portion of the catheter is made of a squeezable and moldable material, such as a silica gel, or a silica gel mixture, or a latex mixture, or a polyolefin, such as Polyethylene (PE) or polypropylene (PP), or a copolymer of polyethylene, such as ethylene vinyl acetate (EVA) or polyvinyl chloride (PVC) or polyvinylidene, by injection molding, extrusion Forming and / or blow molding, or a combination of adhesive bonding, the tip of the catheter, the side balloon, the balloon cavity, the drainage cavity, the drainage hole, the drainage cavity, the balloon through the desired material Water injection or gas injection lumen, drainage cavity drainage lower hole, through balloon injection or gas injection lumen through balloon hole, irrigation lumen, irrigation lumen discharge hole, balloon injection or gas injection anti-backflow valve, drainage chamber cone
  • the interface, the flushing chamber conical interface, and the flushing chamber clamping switch are made in one piece.
  • the Shore hardness of the material for preparing and constituting the tubular portion of the catheter A range is 75-85, Preferably, the range is 78-82; and is radiation resistant to enable it to withstand at least 50 kGy without substantial degradation; it should also have a melting of more than 90 ° C, preferably more than 110 ° C, and most preferably more than 130 ° C. Temperature; The material used to prepare and form the body portion of the catheter should exhibit low elasticity, good kink performance, and good dimensional stability.
  • the polymer blend comprises at least 80% by weight of a polyolefin and in which a medicinal oil and/or a paraffin wax may be blended.
  • balloon water injection or gas injection anti-backflow valve tail pipe and the flushing chamber switch are made of a hard material, and the flushing chamber switch can be separated from the pipe body.
  • the tip of the catheter is smooth, and after the patient realizes the restriction of the contact type side balloon double-port catheter, the urine can be filled or inflated, and the side ball of the head end after water or gas is injected.
  • the balloon is swollen and automatically tilted to one side.
  • the inclined balloon and the urinary catheter and the bottom of the bladder wall have a frame space sufficient to accommodate the bladder triangle.
  • the balloon wall and the tube body are not in contact with the bladder triangle or have a little contact.
  • the drainage lumen is adjacent to the two ureteral orifices, the normal urine in the bladder and the abnormal urine in the bladder, through adsorption , negative pressure, siphoning, etc., can drain all normal urine and abnormal urine in the bladder to the outside of the body, there is no residue in the bladder, and the irrigation lumen is placed on either side of the tip.
  • the inclined surface is connected to the flushing chamber through the irrigation lumen, and the irrigation chamber tapered interface can function as a connector of the catheter, which can be connected to other devices, and the irrigation chamber switch is placed in the irrigation chamber cone Interfaces use the irrigation lumen may be completely blocked, can be injected into the bladder irrigation fluid drug through this channel, if necessary, can be emergency diversion of urine, the patient no pain, remarkable clinical application.
  • FIG. 1 is a schematic view showing the structure of a contact-type side balloon double-port catheter balloon after water injection or gas injection according to the present invention
  • FIG. 2 is a schematic cross-sectional view showing the longitudinal section of the tube end of the contact-type side balloon double-hole urinary catheter through the balloon injection or the infusion lumen;
  • FIG. 3 is a schematic cross-sectional view showing the longitudinal section of the tubular end of the contact-type side balloon double-hole urinary catheter in the middle of the flushing lumen;
  • Figure 4 is a schematic cross-sectional view showing the transverse section of the upper end of the drainage body of the contact-type side balloon double-hole urinary catheter through the drainage cavity of the present invention (after water injection or gas injection, enlarged);
  • Figure 5 is a schematic cross-sectional view showing the transverse cross-sectional structure of the tubular body of the contact-type side balloon double-hole urinary catheter through the balloon injection or the infusion lumen through the balloon hole (after water injection or gas injection, enlarged);
  • Figure 6 is a cross-sectional view of the tube of the contact-type side balloon double-pore catheter of the present invention through the drainage cavity Schematic diagram of the section structure (after filling or injecting gas, zoom in);
  • Figure 7 is a schematic cross-sectional view showing the cross-sectional structure of the tubular body of the contact-type side balloon double-hole urinary catheter through the balloon injection or the infusion lumen through the balloon hole (without water injection or gas injection, enlargement);
  • Figure 8 is a cross-sectional view showing the cross-sectional structure of the tube of the contact-type side balloon double-hole catheter D of the present invention (amplified);
  • Figure 9 is a schematic view showing the structure of the tail end of the contact-type side balloon double-hole urinary catheter according to the present invention.
  • a contact-type side balloon double-hole urinary catheter includes a tube body 1, a tip end 2, a side balloon 15, a balloon chamber 3, and a drainage chamber draining hole 4, Excretion chamber 5, water injection or insufflation lumen 6, drainage chamber drainage lower hole 7, through balloon infusion or insufflation lumen through balloon orifice 8, irrigation lumen 9, irrigation lumen ejection orifice 10, balloon
  • the water injection or gas injection anti-backflow valve 11, the discharge chamber conical interface 12, the flushing chamber conical interface 13, the flushing chamber clamping switch 14, the side balloon 15 of the catheter is placed near the tube 1 of the tip 2
  • the opposite side of the tubular body 15 of the urinary catheter is located near the bottom of the balloon 15 and has a drainage chamber for draining the lower hole 7.
  • the body 1 is beveled. After the patient realizes the restriction of the contact type side balloon double-port catheter, the patient can be filled with water or inflated by the balloon through the balloon or the gas-filled anti-reflux valve 11 to the lateral balloon chamber 3, sterile water. Or the gas enters the balloon injection or the insufflation lumen 6 from the valve 11.
  • the side balloon 15 of the head end is automatically inclined to one side, forming an inflation balloon in the bladder, forming an obstacle, and fixing the catheter.
  • the inclined side balloon 15 is supported by the tubular body 1 of the catheter and the bottom of the bladder wall to accommodate the bladder triangle and the drainage chamber.
  • the lower hole 7 is drained, and the balloon wall is not in contact with the bladder triangle or has a little contact.
  • the catheter can be continuously fixed in the bladder, does not come out, does not compress the bladder triangle, and both sides of the ureteral orifice, draining the lumen under the drainage
  • the hole 7 is adjacent to the two ureteral orifices, and the bladder is positive Urine, abnormal urine and abnormal urine, through the adsorption, negative pressure, siphon, etc., can completely drain the normal urine and abnormal urine in the bladder through the excretory cavity 5, the excretory cavity cone interface 12 to the outside of the body, in the bladder No residue, the drainage chamber tapered interface 12 can function as a connector for the catheter, which can be connected to other devices, such as a collection bag, a drainage tube, a syringe, etc., the irrigation lumen outlet 10 is placed in the The slope of any side tube 1 of the tip 2 is connected to the irrigation chamber conical interface 13 through the irrigation lumen 9, and the irrigation chamber conical interface 13 can function as a connector for the catheter, which can be connected to other devices, rinse
  • the cavity switch 14 is placed in the

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)

Abstract

一种限制接触型侧球囊双孔导尿管，管体（1）由一种聚合物共混物制造，侧球囊（15）置于靠近尖端（2）的管体（1）的一侧，另一侧有排泄腔引流下孔（7）和上孔（4），冲洗管腔出液孔（10）置于尖端（2）。导尿管置于膀胱后，侧球囊（15）在注水或注气状态下，自动倾斜，球囊壁及管体（1）不压迫膀胱三角和输尿管口，排泄管腔引流下孔（7）与输尿管口毗邻，彻底排空膀胱，尿液内无残存。导尿管的尖端（2）、侧球囊（15）、排泄腔引流下孔（7）和上孔（4）、排泄腔（5）、注水或注气管腔（6）、冲洗管腔（9）、冲洗管腔出液孔（10）、抗逆流阀门（11）、排泄腔锥形接口（12）、冲洗腔锥形接口（13）、冲洗腔夹闭开关（14）通过管体（1）连成一个整体件，临床应用成效显著。

Description

说明书
限制接触型侧球囊双孔导尿管 技术领域
本发明涉及一种限制接触型侧球囊双孔导尿管， 属医疗辅助器械技术领域。
背景技术
在医学领域内科疾病、 外科疾病、 妇产科疾病、 骨科疾病及泌尿科疾病需插入导尿管， 留置导尿。 导尿管是一种常用的医疗辅助器械， 可以经由病人尿道插入膀胱以便引导尿液流 出。 导尿管插入膀胱后， 靠近导尿管头端有一个球囊， 用以使导尿管固定留置在膀胱内而不 易脱出， 导尿管的引流部分连接尿袋收集尿液。 留置尿管常见问题有尿路感染、 引流不畅、 拔管困难、 膀胱痉挛或挛缩等， 但最常见的并发症为泌尿系感染。 膀胱底内面的一个三角 形区域,位于两输尿管口与尿道内口之间。 膀胱三角是肿瘤、 结核和炎症的好发部位， 是膀胱镜检查的重点区域,有重要的临床意义。
现有球囊三腔导尿管排泄腔引流孔与膀胱底之间有 3-5cm距离， 并间隔有一球囊， 始终有部分尿液持续残留于膀胱底部； 膀胱内的尿液一般无菌， 但尿液同时也是细菌 适合的环境， 容易滋生细菌； 尿液无法完全排空时， 尿液留在膀胱底部， 任由细菌生 成， 也就容易发炎； 导尿管作为异物长期滞留于膀胱内与残存尿液接触， 易将结石盐沉积 于尿管末端， 形成结石； 球囊充水或充气后呈圆形， 气囊壁持续剌激摩擦膀胱三角， 诱发 炎症， 病人出现尿频、 尿急、 下腹部憋胀不适； 尿道松弛而致漏尿， 老年女性， 颅内病变， 截瘫的患者盆底肌和尿道括约肌松弛而引起漏尿； 传统的导尿管使用方法， 见尿后需要插入 3cm左右， 才能注水或注气。 发明内容 本发明的目的是克服现有球囊三腔导尿管置入体内， 见尿后需要再插入 3cm左右， 才 能注水或充气，球囊导尿管排泄腔引流孔与膀胱底之间有 3-5cm距离，并间隔有一球囊， 始终有部分尿液持续残留于膀胱底部， 滋生细菌， 发生炎症， 形成结石， 引起漏尿； 气 囊壁持续剌激摩擦膀胱三角， 诱发炎症， 病人出现尿频、 尿急、 下腹部憋胀不适等缺陷， 提供了一种限制接触型侧球囊双孔导尿管， 该导尿管置入膀胱后见尿即可注水或充气， 不但 固定牢固， 不脱出， 而且对膀胱三角不产生剌激， 无尿液残留， 无膀胱剌激症， 无漏尿现象， 化解了现有球囊导尿管产生的多种并发症。 为达到上述目的， 采用的技术方案是： 一种限制接触型侧球囊双孔导尿管， 包括管体、 尖端、 侧球囊、 球囊囊腔、 排泄腔引流上孔、 排泄腔、 通球囊注水或注气管腔、 排泄腔引流 下孔、 通球囊注水或注气管腔通球囊孔、 冲洗管腔、 冲洗管腔出液孔、 球囊注水或注气抗逆 流阀门、 排泄腔锥形接口、 冲洗腔锥形接口、 冲洗腔夹闭开关组成， 其特征在于： 所述管体 是由一种聚合物共混物制造， 所述导尿管的侧球囊置于靠近尖端的管体的一侧， 所述导尿管 的侧球囊的管体的对侧靠近球囊的底部有一排泄腔引流下孔，靠近球囊的顶部有一排泄腔引 流上孔， 所述冲洗管腔出液孔置于所述尖端， 位于所述排泄管腔引流孔和所述通球囊注水或 注气管腔通球囊孔形成的平面的两侧中的任一侧管体斜面， 所述导尿管使用方法， 见尿即可 注水或充气， 所述导尿管置于膀胱后的侧球囊在注水或注气状态下， 自动向一侧倾斜， 倾斜 的侧球囊及导尿管与膀胱壁底部组成的构架空间足够容纳膀胱三角，球囊壁及管体与膀胱三 角不接触或有少许接触， 可持续固定所述导尿管于膀胱内， 不脱出， 所述导尿管置于膀胱后 的侧球囊在注水或注气状态下不压迫膀胱三角， 不压迫输尿管口， 所述导尿管置于膀胱后的 侧球囊在注水或注气状态下， 排泄管腔引流下孔与输尿管口毗邻， 膀胱内正常尿液及病变异 常尿液， 及时彻底排空， 膀胱内无残存， 所述导尿管的尖端、 侧球囊、 球囊囊腔、 排泄腔引 流上孔、 排泄腔、 通球囊注水或注气管腔、 排泄腔引流下孔、 通球囊注水或注气管腔通球囊 孔、 冲洗管腔、 冲洗管腔出液孔、 球囊注水或注气抗逆流阀门、 排泄腔锥形接口、 冲洗腔锥 形接口、 冲洗腔夹闭开关通过管体连成一个整体件。
进一步， 所述导尿管置于膀胱后的侧球囊在注水或注气状态下， 由于排泄管腔引流下孔 与输尿管口相邻， 通过吸附、 负压、 虹吸等作用， 可完全使膀胱内的正常尿液及病变异常尿 液引流到体外， 无残留。
进一步， 所述导尿管的管体部分由一种可挤压及可模塑材料制成， 例如由一种硅胶， 或 一种硅胶混合物， 或一种乳胶混合物， 或一种聚烯烃， 如聚乙烯 （PE) 或聚丙烯 （PP)， 或 一种聚乙烯的共聚物， 如乙烯醋酸乙烯酯 （EVA)或聚氯乙烯 (PVC)或聚偏乙烯制成， 通过注 射模塑， 挤压成形和 /或吹塑成形， 或黏附粘接的结合， 通过所需材料可将所述导尿管的尖 端、 侧球囊、 球囊囊腔、 排泄腔引流上孔、 排泄腔、 通球囊注水或注气管腔、 排泄腔引流下 孔、 通球囊注水或注气管腔通球囊孔、 冲洗管腔、 冲洗管腔出液孔、 球囊注水或注气抗逆流 阀门、 排泄腔锥形接口、 冲洗腔锥形接口、 冲洗腔夹闭开关制成一个整体件。
进一步， 为了得到良好的机械性能， 获得足够的硬度用于预期用途， 能通过已知的灭菌 方法彻底灭菌， 用于制备和构成所述导尿管的管体部分的材料的肖氏硬度 A范围为 75-85， 优选范围为 78-82; 且具有辐射抗性以使其能够耐受至少 50kGy而基本上没有降解； 还应具 有超过 90°C， 优选超过 110°C， 并且最优选为超过 130°C的熔融温度； 用于制备和构成所述 导尿管的管体部分的材料应显示出低弹性， 具有良好的扭结性能， 良好的尺寸稳定性。
进一步， 所述聚合物共混物包括至少 80重量％的聚烯烃并且其中可能掺混了医药油和 / 或石蜡。
进一步， 所述球囊注水或注气抗逆流阀门尾部管道和所述冲洗腔开关由硬性材料制作， 所述冲洗腔开关可与所述管体分离。
本发明的有益效果是： 导尿管尖端平滑， 病人实现限制接触型侧球囊双孔导尿管的人体 置入后， 见尿即可注水或充气， 注水或气后所述头端的侧球囊胀大并自动向一侧倾斜， 倾斜 的球囊及导尿管与膀胱壁底部组成的构架空间足够容纳膀胱三角，所述球囊壁及管体与膀胱 三角不接触或有少许接触， 可持续固定所述导尿管于膀胱内， 不脱出， 不压迫膀胱三角， 及 两侧输尿管口， 排泄管腔引流下孔与两输尿管口毗邻， 膀胱内正常尿液及病变异常尿液， 通 过吸附、 负压、 虹吸等作用， 可使膀胱内的正常尿液及病变异常尿液全部引流到体外， 膀胱 内无残留，所述冲洗管腔出液孔置于所述尖端的任一侧管体斜面通过冲洗管腔与冲洗腔锥形 接口接通， 冲洗腔锥形接口可起到导尿管的连接器作用， 其可连接到其它装置， 冲洗腔开关 置于冲洗腔锥形接口， 使用时可完全阻断所述冲洗管腔， 可通过此通道向膀胱内注入冲洗药 液， 必要时可应急导流尿液， 患者无痛苦， 临床应用成效显著。 附图说明 以下结合附图说明和具体实施方式对本发明作进一步说明：
图 1为本发明限制接触型侧球囊双孔导尿管球囊注水或注气后的结构示意图；
图 2为本发明限制接触型侧球囊双孔导尿管的管体头端经通球囊注水或注气管腔正中的纵 形截剖面结构示意图；
图 3为本发明限制接触型侧球囊双孔导尿管的管体头端经冲洗管腔正中的纵形截剖面结构 示意图；
图 4为本发明限制接触型侧球囊双孔导尿管的管体经排泄腔引流上孔正中的横形截剖面结 构示意图 （注水或注气后， 放大）；
图 5为本发明限制接触型侧球囊双孔导尿管的管体经通球囊注水或注气管腔通球囊孔正中 的横形截剖面结构示意图 （注水或注气后， 放大）；
图 6为本发明本发明限制接触型侧球囊双孔导尿管的管体经排泄腔引流下孔正中的横形截 剖面结构示意图 （注水或注气后， 放大）；
图 7为本发明限制接触型侧球囊双孔导尿管的管体经通球囊注水或注气管腔通球囊孔正中 的横形截剖面结构示意图 （未注水或注气， 放大）；
图 8为图 9本发明限制接触型侧球囊双孔导尿管 D处管体的横形截剖面结构示意图 （放 大)；
图 9为本发明本发明限制接触型侧球囊双孔导尿管的尾端结构示意图；
图中： 1—管体； 2—尖端； 3—球囊囊腔； 4一排泄腔引流上孔； 5—排泄腔； 6—通球囊注 水或注气管腔； 7—排泄腔引流下孔； 8—通球囊注水或注气管腔通球囊孔； 9一冲洗管腔； 10—冲洗管腔出液孔； 11一球囊注水或注气抗逆流阀门； 12—排泄腔锥形接口； 13—冲洗腔 锥形接口； 14一冲洗腔夹闭开关； 15—侧球囊； A—管体经排泄腔引流上孔正中的横形截剖 面； B—管体经通球囊注水或注气管腔通球囊孔正中的横形截剖面； C一管体经排泄腔引流 下孔正中的横形截剖面； D—管体的横形截剖面； E—管体头端经冲洗管腔正中的纵形截剖 面； F—管体头端经通球囊注水或注气管腔正中的纵形截剖面。 具体实施方式
在附图 1至附图 9中， 一种限制接触型侧球囊双孔导尿管， 包括管体 1、 尖端 2、 侧球 囊 15、 球囊囊腔 3、 排泄腔引流上孔 4、 排泄腔 5、 通球囊注水或注气管腔 6、 排泄腔引流下 孔 7、 通球囊注水或注气管腔通球囊孔 8、 冲洗管腔 9、 冲洗管腔出液孔 10、 球囊注水或注 气抗逆流阀门 11、排泄腔锥形接口 12、冲洗腔锥形接口 13、冲洗腔夹闭开关 14组成， 导尿 管的侧球囊 15置于靠近尖端 2的管体 1的一侧，导尿管的侧球囊 15的所处管体 1的对侧靠 近球囊 15的底部有一排泄腔引流下孔 7， 靠近球囊 15的顶部有一排泄腔引流上孔 4， 冲洗 管腔出液孔 10置于尖端 2， 位于排泄管腔引流上孔 4、排泄管腔引流下孔 7和通球囊注水或 注气管腔通球囊孔 8形成的平面的两侧中的任一侧管体 1斜面。 病人实现限制接触型侧球囊双孔导尿管的人体置入后，见尿即可用注射器经球囊注水或 注气抗逆流阀门 11向侧球囊囊腔 3同时注水或充气， 无菌水或气体自阀门 11进入通球囊注 水或注气管腔 6，注水或气后所述头端的侧球囊 15 自动向一侧倾斜，在膀胱内形成膨胀球囊， 形成障碍， 固定导尿管， 确保限制接触型侧球囊双孔导尿管不从尿道中脱出， 倾斜的侧球囊 15在导尿管的管体 1支撑下与膀胱壁底部组成的构架空间，足够容纳膀胱三角、排泄腔引流 下孔 7， 而球囊壁与膀胱三角不接触或有少许接触， 可持续固定所述导尿管于膀胱内， 不脱 出， 不压迫膀胱三角， 及两侧输尿管口， 排泄管腔引流下孔 7与两输尿管口毗邻， 膀胱内正 常尿液及病变异常尿液， 通过吸附、 负压、 虹吸等作用， 可完全使膀胱内的正常尿液及病变 异常尿液通过排泄腔 5、 排泄腔锥形接口 12引流到体外， 膀胱内无残留， 排泄腔锥形接口 12可起到导尿管的连接器作用， 其可连接到其它装置， 例如收集袋、 引流管、 注射器等， 所 述冲洗管腔出液孔 10置于所述尖端 2的任一侧管体 1斜面通过冲洗管腔 9与冲洗腔锥形接 口 13接通， 冲洗腔锥形接口 13可起到导尿管的连接器作用， 其可连接到其它装置， 冲洗腔 开关 14置于冲洗腔锥形接口 13， 使用时可完全阻断所述冲洗管腔， 可通过此通道向膀胱内 注入冲洗药液， 必要时可应急导流尿液， 患者无痛苦， 临床应用成效显著。 最后说明的是， 以上实施例仅用以说明本发明的技术方案而非限制， 尽管参照较佳实施 例对本发明进行了详细说明， 本领域的普通技术人员应当理解， 可以对本发明的技术方案进 行修改或者等同替换， 而不脱离本发明技术方案的宗旨和范围， 其应涵盖在本发明的权利要 求范围当中。

Claims

权利要求书
1， 一种限制接触型侧球囊双孔导尿管， 包括管体、 尖端、 侧球囊、 球囊囊腔、 排泄腔引流上孔、 排泄腔、 通球囊注水或注气管腔、 排泄腔引流下孔、 通球囊注水或 注气管腔通球囊孔、 冲洗管腔、 冲洗管腔出液孔、 球囊注水或注气抗逆流阀门、 排泄 腔锥形接口、 冲洗腔锥形接口、 冲洗腔夹闭开关， 其特征在于： 所述管体是由一种聚 合物共混物制造， 所述导尿管的侧球囊置于靠近尖端的管体的一侧， 所述导尿管的侧 球囊的管体的对侧靠近球囊的底部有一排泄腔引流下孔，靠近球囊的顶部有一排泄腔 引流上孔， 所述冲洗管腔出液孔置于导尿管的尖端， 位于所述排泄腔引流上孔、 排泄 腔引流下孔和所述通球囊注水或注气管腔通球囊孔形成的平面的两侧中的任一侧管 体斜面， 所述导尿管的尖端、 侧球囊、 球囊囊腔、 排泄腔引流上孔、 排泄腔、 通球囊 注水或注气管腔、 排泄腔引流下孔、 通球囊注水或注气管腔通球囊孔、 冲洗管腔、 冲 洗管腔出液孔、 球囊注水或注气抗逆流阀门、 排泄腔锥形接口、 冲洗腔锥形接口、 冲 洗腔夹闭开关通过所述管体连成一体。
2， 根据权利要求 1所述一种限制接触型侧球囊双孔导尿管， 其特征在于： 所述 导尿管置于膀胱后的侧球囊在注水或注气状态下， 排泄管腔引流下孔与输尿管口相 邻， 可排空膀胱内尿液， 无残留。
3， 根据权利要求 1或 2所述的限制接触型侧球囊双孔导尿管， 其特征在于： 所 述管体由一种可挤压及可模塑材料制成。
4， 根据权利要求 1或 2所述的限制接触型侧球囊双孔导尿管， 其特征在于： 所 述球囊注水或注气抗逆流阀门尾部管道和所述冲洗腔开关由硬性材料制作，所述冲洗 腔开关可与所述管体分离。
5， 根据权利要求 1或 2所述的限制接触型侧球囊双孔导尿管， 其特征在于： 所 述聚合物共混物包括至少 80重量％的聚烯烃， 并且其中掺混医药油和 /或石蜡。
6， 根据权利要求 1或 2所述的限制接触型侧球囊双孔导尿管， 其特征在于： 所 述基体的肖氏硬度 A范围为 75-85。
7， 根据权利要求 1或 2所述的限制接触型侧球囊双孔导尿管， 其特征在于： 所 述基体具有辐射抗性以使其能够耐受至少 50kGy而基本上没有降解。
8， 根据权利要求 1或 2所述的限制接触型侧球囊双孔导尿管， 其特征在于： 所 述基体具有超过 90°C的熔融温度。
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JP2016527013A (ja) 2016-09-08

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