WO2017049823A1 - 一种前列腺扩裂导管 - Google Patents

一种前列腺扩裂导管 Download PDF

Info

Publication number
WO2017049823A1
WO2017049823A1 PCT/CN2016/072130 CN2016072130W WO2017049823A1 WO 2017049823 A1 WO2017049823 A1 WO 2017049823A1 CN 2016072130 W CN2016072130 W CN 2016072130W WO 2017049823 A1 WO2017049823 A1 WO 2017049823A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
prostate
catheter
chamber
cracking
Prior art date
Application number
PCT/CN2016/072130
Other languages
English (en)
French (fr)
Inventor
郭应禄
张志超
袁亦铭
邢念增
田龙
王科
于胜强
赵宏江
荆学军
Original Assignee
北京优尼康通医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 北京优尼康通医疗科技有限公司 filed Critical 北京优尼康通医疗科技有限公司
Priority to JP2017544819A priority Critical patent/JP2017537755A/ja
Priority to KR1020177017815A priority patent/KR20170088979A/ko
Priority to US15/531,930 priority patent/US20170340868A1/en
Publication of WO2017049823A1 publication Critical patent/WO2017049823A1/zh

Links

Images

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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • 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
    • A61M25/1011—Multiple balloon catheters
    • 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
    • A61M25/10181—Means for forcing inflation fluid into the balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024—Expandable catheters or sheaths
    • 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
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A61M2029/025—Dilators made of swellable material characterised by the guiding element
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/16—Male reproductive, genital organs
    • A61M2210/166—Prostate

Definitions

  • the invention relates to a novel prostate expansion catheter, in particular to a composite rod-shaped water balloon prostate expansion catheter with an inner capsule at the front end of the outer capsule.
  • Benign prostatic hyperplasia is a common benign disease in older men. The incidence of over 60 years old accounts for 65%, and 25% of patients have clinical symptoms requiring medication or surgery. The traditional transurethral resection of the prostate or the effect of electric resection and laser surgery is determined, but the operation has a greater impact on the patient, and the elderly have relatively poor tolerance to the body and psychological capacity of the operation. Therefore, many elderly patients are afraid of surgery. . Long-term maintenance by the urinary catheter, and even only the suprapubic bladder fistula to solve dysuria. The quality of life is extremely poor. The use of posterior urethral expansion for the treatment of benign prostatic hyperplasia is currently the medical profession should pay attention to the study of the treatment of benign prostatic hyperplasia.
  • the outer capsule of most prostate expansion catheters in the prior art is circular, spherical, curved or streamlined, etc., and its structure is as shown in FIG.
  • the prostate expansion catheter of the application No. CN201010578449.8, which is filed by the applicant, includes an inner capsule and an outer capsule, the inner capsule is located in a front section of the outer capsule, and the front end of the inner and outer capsules Opening into the inner and outer capsules respectively, the outer capsule has a rod shape after expansion, and its structure is as shown in FIG. 2.
  • the outer capsule is positioned in the bladder neck, when the internal pressure is pressurized, the internal slip is not easy to control, and the expansion effect is unstable.
  • the outer capsule is columnar after expansion, it is not conducive to intraoperative sliding into the bladder to avoid prolonged compression of the external sphincter, and is not conducive to postoperative traction and compression to stop bleeding; Located at the back end of the outer capsule, it is not conducive to preoperative positioning and postoperative fixation of the catheter, there may be a risk of bladder spasm caused by postoperative internal capsule compression of the glandular fossa.
  • the present invention provides a novel prostate expansion catheter, wherein the outer capsule in the composite high pressure water bladder is a rod having a large head end and a small end, and the shape is expanded. After opening the neck of the bladder, the catheter will automatically move into the bladder, thereby relieving the compression of the external sphincter to prevent the occurrence of urinary incontinence.
  • the internal capsule is located at the inner end of the outer capsule, which is more conducive to preoperative positioning and postoperative fixation of the catheter. The appearance of bladder spasm caused by compression of the glandular fossa after surgery is avoided. Meanwhile, since the positioning ring is provided at the tail end of the outer capsule, whether or not the catheter moves into the bladder can be determined by touching the positioning ring.
  • the efficacy and safety results of the application of the prostate expansion catheter in the treatment of benign prostatic hyperplasia of the present invention are as follows: 35 cases of urinary excretion after 5 to 7 days of extubation, 1 case of transient urinary incontinence, recovered after one month.
  • the international prostate symptom score decreased from preoperative (26.7+2.5) points to (6.1+2.0) points; B-ultrasound determination of residual urine volume decreased from preoperative (132.2+5.2) ml to postoperative (24.1+3.6) ml; maximum urine The flow rate increased from preoperative (6.5+2.3) ml/s to (21.8+2.7) ml/s; the difference of urinary indexes before and after treatment was statistically significant (p ⁇ 0.05).
  • This method is a simple method. A safe, effective method for patients with various degrees of benign prostatic hyperplasia, including mid-lobular hyperplasia.
  • the object of the present invention is to provide a novel prostate cracking catheter which adopts such a shape that the catheter will automatically move into the bladder after expanding the neck of the bladder, thereby relieving the compression of the external sphincter to prevent the occurrence of urinary incontinence; Conducive to preoperative positioning and postoperative fixation of the catheter, can avoid The catheter is prevented from causing irritation to the glandular fossa after surgery; at the same time, since the positioning ring is provided at the end of the outer capsule, whether or not the catheter moves into the bladder can be determined by touching the positioning ring.
  • a novel prostate expansion catheter includes a main tube, wherein the main tube is provided with a catheterization chamber, an irrigation chamber, an inner capsule chamber and an outer capsule chamber, and an outlet of the catheterization chamber and a rear portion of the outlet of the irrigation chamber are provided.
  • a composite rod-shaped high-pressure water bladder comprising an inner capsule and an outer capsule, the inner capsule being located at a front end of the outer capsule, the front ends of the inner and outer capsules respectively opening In the inner capsule and outer capsule.
  • the inner bag is filled with water into the inner bag cavity through the inner bag pressurizing port
  • the outer bag is filled with water in the outer bag cavity through the outer bag pressurizing port
  • the inner capsule is spherical after being pressed for positioning, and the outer capsule is pressed into a rod shape with a thick front end and a narrow end, and is used for expanding the neck neck and the external sphincter.
  • flushing chamber communicates with the flushing chamber inlet and the flushing chamber outlet through an irrigation tube, and the inlet and outlet of the catheterizing chamber directly pass through the entire main tube.
  • the main tube at the rear of the outer bag is provided with a positioning ring or a positioning protrusion, which can be developed under X-ray or can be touched during rectal examination.
  • the positioning ring or the positioning protrusion is made of a metal material.
  • the outer capsule has a length of 7-13 cm and the inner capsule has a length of 2-5 cm.
  • the diameter of the main pipe is 5-6 cm
  • the material is PVC or PE
  • the materials of the inner bag and the outer bag are composite materials.
  • the diameter of the inner capsule is the same as the diameter of the front end of the outer capsule, and the diameter of the middle portion of the outer capsule is 2.5 cm - 4 cm.
  • the inner bag has a water filling capacity of 20-50 ml
  • the outer bag has a water filling pressure of 0.3 MPa. after the operation, the outer bag water is released to reduce the outer bag pressure to 0.1 mpa. Stop bleeding.
  • the catheter positioning is accurate and convenient. 2. After opening the prostate, it can automatically move inward to relieve the compression of the external sphincter, without excessive damage to the external sphincter and prevent urinary incontinence.
  • FIG. 1 to FIG. 6 Please refer to FIG. 1 to FIG. 6 , wherein
  • Figure 1-2 is a diagram of the prior art of the present invention.
  • Figure 3 is a front elevational view of Embodiment 1 of the present invention.
  • Figure 4 is a front elevational view of Embodiment 2 of the present invention.
  • Figure 5 is a cross-sectional view of Figure 3;
  • Figure 6 is a cross-sectional view of the main pipe.
  • connection In the description of the present invention, it should be noted that the terms “installation”, “connected”, and “connected” are to be understood broadly, and may be fixed or detachable, for example, unless otherwise explicitly defined and defined. Connected, or connected in one piece; can be mechanical or electrical; It is directly connected, or it can be connected indirectly through an intermediate medium, which can be the internal connection between two components.
  • intermediate medium which can be the internal connection between two components.
  • FIG. 1 is a front view of a first embodiment of the present invention
  • FIG. 4 is a front view of a third embodiment of the present invention
  • FIG. 3 is a cross-sectional view
  • FIG. 6 is a cross-sectional view of the main pipe.
  • the outer capsule is circular, spherical, curved or streamlined.
  • a disadvantage of the catheter of this shape is that the internal slip is not easily controlled when the inside of the outer capsule is pressurized, and the expansion effect is also unstable.
  • Figure 2 is a prostate cracking catheter of the applicant application number CN201010578449.8, comprising an inner capsule and an outer capsule, the inner capsule being located in a posterior segment of the outer capsule, the inner capsule and the outer capsule The front end of the cavity is respectively opened in the inner bag and the outer bag, and the shape of the outer bag after expansion is columnar.
  • a disadvantage of this type of catheter is that the inner capsule is located at the rear end of the outer capsule, which is not conducive to preoperative positioning and postoperative fixation of the catheter, and there may be a risk that the inner capsule compresses the glandular fossa to cause bladder spasm.
  • Figure 3 is a schematic view showing the structure of the first embodiment of the present invention.
  • a novel prostate expansion catheter includes a main tube 9 in which a catheterization chamber 11, an irrigation chamber 13, an inner capsule chamber 12 and an outer capsule chamber 14 are provided, and the catheter chamber outlet is provided. 8 and a rear portion of the flushing chamber outlet 7 is provided with a composite rod-shaped high-pressure water bladder including an inner bladder 3 and an outer bladder 4, the inner bladder 3 being located at a front end of the outer bladder 4, The front ends of the inner and outer capsules 12, 14 are opened in the inner and outer bladders 3, 4, respectively.
  • Figure 4 is a schematic view showing the structure of a second embodiment of the present invention.
  • the main tube 9 at the rear of the outer bag 4 is provided with a positioning ring or a positioning protrusion 10, which can be developed under X-ray or a rectal finger. Touched at the time of diagnosis.
  • the positioning ring or the positioning protrusion 10 is made of a metal material.
  • Figures 5 and 6 show the internal structure of the supervisor of the present invention.
  • the main tube 9 is provided with a catheter guiding chamber 11, an irrigation chamber 13, an inner capsule chamber 12 and an outer capsule chamber 14, and the flushing chamber 13 communicates with the flushing chamber inlet 7 through an irrigation tube 2a and The chamber outlet 2 is flushed, and the catheter inlet 1 and the catheter outlet 8 directly pass through the entire main tube 9.
  • the inner bag 3 is filled with water into the inner bag tube 3a through the inner bag pressurizing port 5, and the outer bag 4 is filled with water in the outer bag tube 4a through the outer bag pressurizing port 6.
  • the inner bag 3 is spherically used for positioning after being pressurized, and the outer bag 4 is pressed into a rod shape having a thick front end and a narrow end, and is used for expanding the neck neck and the external sphincter.
  • the outer capsule has a length of 7-13 cm and the inner capsule has a length of 2-5 cm.
  • the diameter of the inner capsule is the same as the diameter of the front end of the outer capsule, and the diameter of the middle portion of the outer capsule is 2.5 cm - 4 cm.
  • the main pipe has a circumference of 5-6 cm and is made of PVC or PE.
  • the inner and outer bladders are made of a composite material.
  • the catheter of the present invention is designed with two inner and outer capsules and a positioning ring.
  • the inner capsule is spherical for positioning, and the outer capsule is rod-shaped for expanding the neck and external sphincters of the bladder.
  • the catheter is inserted into the bladder through the urethra.
  • 20 ml of physiological saline is injected into the inner capsule.
  • the inner capsule is filled with water and then spherical, and then the catheter is positioned outward.
  • the pressure of the pressure can be controlled by the pressure device of the outer capsule to fill the outer capsule with physiological saline until the surface pressure of the outer capsule reaches 0.3 MPa.
  • the bladder neck and external sphincter are expanded, and the prostate and surgical capsule are expanded simultaneously, and then the outer capsule water is released to reduce the pressure of the outer capsule to 0.1 MPa for hemostasis.
  • the catheter Since the outer capsule is filled with water and has a thicker front end and a thinner rear end, the catheter will automatically move into the bladder after the bladder neck is opened, thereby relieving the compression of the external sphincter to prevent the occurrence of urinary incontinence. At the same time, it is possible to determine whether the catheter moves into the bladder by touching the positioning ring.
  • the outer capsule water can be completely released and the internal capsule pressure can be used to fix the catheter. Because the inner capsule is located at the inner head end of the outer capsule, it is more conducive to preoperative positioning and postoperative fixation of the catheter, and also avoids the appearance of bladder spasm caused by compression of the gland fossa after surgery.
  • the main pathological feature of hyperplasia is the interstitial hyperplasia of fibromuscular formation.
  • the proliferating glands protrude to both sides and the bladder, which makes the posterior urethra prolonged and the bladder outlet resistance increases.
  • the high-pressure water bladder after injecting physiological saline can bluntly rupture the prostate surgical capsule from the front, and the glandular leaves on both sides are also opened, and the surgeon extends the indication.
  • the rectum can visually sense the morphological changes of the anterior part of the prostate before and after the expansion.
  • the smooth muscle fibrosis and the reduction of collagen content make it unable to retract, the surrounding tissue is embedded in the cracked prostate capsule, and the split gland cannot be closed, thereby forming an upper mouth in the urethra. Wide and narrow cavity to achieve long-term patency of the urethra.
  • the rod After the outer capsule is filled with water, the rod has a thicker front end and a thinner rear end. Therefore, after the bladder neck is opened, the catheter will automatically move into the bladder, thereby relieving the pressure of the external sphincter to prevent the occurrence of urinary incontinence.
  • the inner capsule is located at the front end of the outer capsule, which is conducive to preoperative positioning and postoperative fixation of the catheter, effectively avoiding bladder spasm caused by postoperative compression of the glandular fossa.
  • the main tube at the back of the outer capsule is provided with a positioning ring or a positioning protrusion, which can be developed under X-ray or can be touched during rectal examination. By touching the positioning ring, it is judged whether the catheter moves into the bladder after insertion.

Abstract

一种前列腺扩裂导管，包括主管（9），主管（9）内设有导尿腔（11）、内囊腔（12）、外囊腔（14）和冲洗腔（13），导尿腔（11）的出口（8）和冲洗腔（13）的入口（7）的前部设有复合棒状高压水囊，该复合棒状高压水囊包括内囊（3）和外囊（4），内囊（3）位于外囊（4）内的前端，内囊腔（12）和外囊腔（14）的前端分别开口于该内囊（3）和外囊（4）中。采用这种结构使得扩开膀胱颈口后导管会自动向膀胱内移动，从而解除对外括约肌的压迫预防尿失禁的发生；此外，更有利于术前定位及术后固定导管，能够避免导管在手术后压迫腺窝引起膀胱痉挛。

Description

一种前列腺扩裂导管 技术领域
本发明涉及一种新型前列腺扩裂导管，尤其涉及一种内囊位于外囊前端的复合棒状水囊前列腺扩裂导管。
背景技术
前列腺增生症(BPH)是老年男性常见的良性病变。60岁以上的发病率占65％，25％患者出现临床症状需药物或外科治疗。传统的经膀胱前列腺摘除术或电切、激光手术效果是确定的，但手术对患者打击较大，且老年人对手术的身体承受能力及心理承受能力都相对较差，故许多老年患者恐惧手术。长期靠插尿管维持，甚至仅做耻骨上膀胱造瘘来解决排尿困难。生活质量极差。采用后尿道扩裂术治疗前列腺增生，是目前医学界应重视研究治疗前列腺增生的方法。
现有技术中的前列腺扩裂导管大致分为以下两类：
1、为了便于插入，现有技术中大部分前列腺扩裂导管的外囊呈圆形、球形、弧形或流线型等，其结构如附图1中所示。
2、本申请人所申请的申请号为CN201010578449.8的前列腺扩裂导管包括内囊和外囊，所述内囊位于所述外囊内的前段，所述内囊腔和外囊腔的前端分别开口于所述内囊和外囊中，所述外囊扩张后的形状呈棒状，其结构如附图2中所示。
对于第一类的前列腺扩裂导管而言，由于外囊定位于膀胱颈部，其内部充压时，内滑不易控制，且扩张效果不稳定。
对于第二类的前列腺扩裂导管而言，由于外囊在扩张之后呈柱状，不利于术中向膀胱内滑动避免长时间压迫外括约肌，也不利于术后牵拉压迫止血；此外，内囊位于外囊后端，不利于术前定位及术后固定导管，可能存在术后内囊压迫腺窝引起膀胱痉挛的危险。
针对现有技术中存在的上述缺陷，本发明提供一种新型的前列腺扩裂导管，其中的复合高压水囊中的外囊为头端较大，末端较小的棒状，采用这种形状使得扩开膀胱颈口后导管会自动向膀胱内移动，从而解除对外括约肌的压迫预防尿失禁的发生；此外，内囊位于外囊的内部头端，更有利于术前定位及术后固定导管，也避免了导管在手术后压迫腺窝引起膀胱痉挛的出现；同时，由于在外囊的尾端设置了定位环，导管是否向膀胱内移动可通过触摸定位环来确定。
通过临床试验，应用本发明中前列腺扩裂导管治疗前列腺增生症疗效及安全性结果如下：5～7天拔管后35例均排尿良好，1例一过性尿失禁，一个月后恢复。国际前列腺症状评分由术前(26.7+2.5)分下降到(6.1+2.0)分；B超测定残余尿量由手术前(132.2+5.2)ml降至术后(24.1+3.6)ml；最大尿流率由术前(6.5+2.3)ml/s升至(21.8+2.7)ml/s；治疗前后各项排尿指标比较差异均有统计学意义(p〈0.05)结论：本法是一种简便、安全、有效的方法，适应于包括中叶增生在内的各种程度前列腺增生的病人。
发明内容
本发明的目的在于，提供一种新型的前列腺扩裂导管，采用这种形状使得扩开膀胱颈口后导管会自动向膀胱内移动，从而解除对外括约肌的压迫预防尿失禁的发生；此外，更有利于术前定位及术后固定导管，能够避 免了导管在手术后对腺窝引起刺激；同时，由于在外囊的尾端设置了定位环，导管是否向膀胱内移动可通过触摸定位环来确定。
为了达到上述目的，本发明的技术方案是这样实现的：
一种新型前列腺扩裂导管，包括主管，所述主管内设有导尿腔、冲洗腔、内囊腔和外囊腔，所述导尿腔的出口和所述冲洗腔的出口的后部设有复合棒状高压水囊，所述复合棒状高压水囊包括内囊和外囊，所述内囊位于所述外囊内的前端，所述内囊腔和外囊腔的前端分别开口于所述内囊和外囊中。
进一步地，所述内囊通过内囊加压口向内囊腔中进行注水加压，所述外囊通过外囊加压口向外囊腔中进行注水加压。
进一步地，所述内囊加压后呈球形用于定位，所述外囊加压后呈前端粗后端细的棒状，用于扩开膀胱颈口及外括约肌。
进一步地，所述冲洗腔通过一根冲洗管连通冲洗腔入口和冲洗腔出口，所述导尿腔的入口和出口直接贯通整个主管。
进一步地，所述外囊后部的主管上设有定位环或定位突，可在X光下显影也可以做直肠指诊时触摸到。
进一步地，所述定位环或定位突为金属材质。
进一步地，所述外囊的长度为7-13cm，内囊的长度为2-5cm。
进一步地，所述主管直径径为5-6cm，材质为PVC或PE，所述内囊和外囊的材质均为复合材料。
进一步地，所述内囊直径与所述外囊前端直径相同，外囊中段直径为2.5cm－4cm。
进一步地，手术中，所述内囊的充水量为20-50毫升，所述外囊的充水压强为0.3MPa，手术后，将外囊水放出部分使外囊压强降至0.1mpa用于止血。
与目前市场上的扩开导管相比具有以下优势：1，导管定位准确方便。2.扩开前列腺后可自动向内移动，解除对外括约肌的压迫，不会过度损伤外括约肌，预防尿失禁。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本发明的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
请参考图1至图6，其中，
图1-2为本发明现有技术的图；
图3为本发明实施例1的主视图；
图4为本发明实施例2的主视图；
图5为图3的剖视图；
图6为主管的剖视图。
图1至图6中部件名称与附图标记的对应关系为：
1、导尿腔入口，2、冲洗腔出口，
3、内囊，4、外囊，
5、内囊加压口，6、外囊加压口，
7、冲洗腔入口，8、导尿腔出口，
9、主管，10、定位环，
11、导尿腔，12、内囊腔，
13、冲洗腔，14、外囊腔，
2a、冲洗管，3a、内囊管，
4a、外囊管。
具体实施方式
下面将结合附图对本发明的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
在本发明的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以 是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
请参考图1至图6，其中，图1-2为本发明现有技术的图；图3为本发明实施例1的主视图；图4为本发明实施例3的主视图；图5为图3的剖视图，图6为主管的剖视图。
下面结合附图对本发明进行进一步详细说明：
图1是现有技术中普遍存在的一类前列腺扩裂导管，为了便于插入，其外囊呈圆形、球形、弧形或流线型。这种形状的导管缺点在于，当外囊内部充压时，内滑不易控制，且扩张效果也不稳定。
图2是本申请人所申请的申请号为CN201010578449.8的前列腺扩裂导管，包括内囊和外囊，所述内囊位于所述外囊内的后段，所述内囊腔和外囊腔的前端分别开口于所述内囊和外囊中，所述外囊扩张后的形状呈柱状。这种形状的导管缺点在于，内囊位于外囊后端，不利于术前定位及术后固定导管，可能存在内囊压迫腺窝引起膀胱痉挛的危险。
图3是本发明第一种实施方式的结构示意图。
如图3所示，一种新型前列腺扩裂导管，包括主管9，所述主管9内设有导尿腔11、冲洗腔13、内囊腔12和外囊腔14，所述导尿腔出口8和所述冲洗腔出口7的后部设有复合棒状高压水囊，所述复合棒状高压水囊包括内囊3和外囊4，所述内囊3位于所述外囊4内的前端，所述内囊腔12和外囊腔14的前端分别开口于所述内囊3和外囊4中。
图4是本发明第二种实施方式的结构示意图。
如图4所示，在第一种实施方式的基础上，进一步地，所述外囊4后部的主管9上设有定位环或定位突10，可在X光下显影也可以做直肠指诊时触摸到。进一步地，所述定位环或定位突10为金属材质。
图5、图6揭示了本发明主管的内部结构图。
如图5、图6所示，主管9内设有导尿腔11、冲洗腔13、内囊腔12和外囊腔14，所述冲洗腔13通过一根冲洗管2a连通冲洗腔入口7和冲洗腔出口2，所述导尿腔入口1和导尿腔出口8直接贯通整个主管9。所述内囊3通过内囊加压口5向内囊管3a中进行注水加压，所述外囊4通过外囊加压口6向外囊管4a中进行注水加压。
所述内囊3加压后呈球形用于定位，所述外囊4加压后呈前端粗后端细的棒状，用于扩开膀胱颈口及外括约肌。
所述外囊的长度为7-13cm，内囊的长度为2-5cm。所述内囊直径与所述外囊前端直径相同，外囊中段直径为2.5cm－4cm。
所述主管周径为5-6cm，材质为PVC或PE，所述内囊和外囊的材质均为复合材料。
在实际手术中，本扩裂导管的具体操作如下：
本发明的导管设计有内外两个囊和一个定位环，内囊呈球形用于定位，外囊呈棒状用于扩开膀胱颈口及外括约肌。
操作时将导管经尿道插入膀胱，首先向内囊注入生理盐水20毫升，内囊充水后呈球形，然后向外牵拉导管定位。定位后通过可控制压强的加压仪器通过外囊加压口向外囊内充入生理盐水至外囊表面压强达到0.3MPa， 随着外囊的扩张扩开膀胱颈口和外括约肌，同时扩开前列腺及外科包膜，随后将外囊水放出部分使外囊压力降至0.1MPa用于止血。
由于外囊充水后呈前端较粗、后端较细的棒状，故扩开膀胱颈口后导管会自动向膀胱内移动，从而解除对外括约肌的压迫预防尿失禁的发生。同时可以通过触摸定位环来确定导管是否向膀胱内移动。
术后六小时，可将外囊水完全放出保留内囊压力用于固定导管。由于内囊位于外囊的内部头端，更有利于术前定位及术后固定导管，也避免了导管在手术后压迫腺窝引起膀胱痉挛的出现。
增生时的主要病理特征是纤维肌肉构成的间质增生。增生的腺体向两侧和膀胱内突出，使后尿道延长变窄，膀胱出口阻力增大。基于上述发病机制，采用本发明的扩裂导管，注入生理盐水后的高压水囊可以将前列腺外科包膜从前方钝性撕裂开，两侧腺叶也随之开，术者以示指伸入直肠，可以直观地感受扩裂前后前列腺前部的形态变化。之后裂开的前列腺组织炎性浸润，平滑肌纤维变性及胶原含量减少使其无法回缩，周围组织嵌入裂开的前列腺包膜处，裂开的腺体无法闭合，从而在尿道内口形成一个上宽下窄的腔隙，实现尿道的长期通畅。
与目前市场上的扩开导管相比具有以下优势：
1、外囊充水后呈前端较粗、后端较细的棒状，故扩开膀胱颈口后导管会自动向膀胱内移动，从而解除对外括约肌的压迫预防尿失禁的发生。
2、内囊位于外囊内部的前端，有利于术前定位及术后固定导管，有效地避免了术后压迫腺窝引起膀胱痉挛。
3、外囊后部的主管上设有定位环或定位突，可在X光下显影也可以做直肠指诊时触摸到，通过触摸该定位环来判断导管插入后是否向膀胱内移动。
通过本组35例BPH患者的手术治疗及随访结果来看：经尿道棒状水囊前列腺扩裂术对BPH患者实施治疗，中短期疗效显著，该术式安全性高，价格相对低廉，值得在临床推广应用，适用于各级医院。
最后应说明的是：以上各实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述各实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。

Claims (10)

  1. 一种前列腺扩裂导管，包括主管，所述主管内设有导尿腔、冲洗腔、内囊腔和外囊腔，所述导尿腔的出口和所述冲洗腔的出口的前方设有复合棒状高压水囊，所述复合棒状高压水囊包括内囊和外囊，其特征在于，所述内囊位于所述外囊内的前端，所述内囊腔和外囊腔的前端分别开口于所述内囊和外囊中。
  2. 根据权利要求1所述的前列腺扩裂导管，其特征在于，所述内囊通过内囊加压口向内囊腔中进行注水加压，所述外囊通过外囊加压口向外囊腔中进行注水加压。
  3. 根据权利要求2所述的前列腺扩裂导管，其特征在于，所述内囊加压后呈球形用于定位，所述外囊加压后呈前端粗后端细的棒状，用于扩开膀胱颈口及外括约肌。
  4. 根据权利要求1所述的前列腺扩裂导管，其特征在于，所述冲洗腔通过一根冲洗管连通冲洗腔入口和冲洗腔出口，所述导尿腔的入口和出口直接贯通整个主管。
  5. 根据权利要求1所述的前列腺扩裂导管，其特征在于，所述外囊后部的主管上设有定位环或定位突，做直肠指诊时能够触摸到。
  6. 根据权利要求5所述的前列腺扩裂导管，其特征在于：所述定位环或定位突为金属材质，可在x光下显影。
  7. 根据权利要求1所述的前列腺扩裂导管，其特征在于，所述外囊的长度为7-13cm，内囊的长度为2-5cm。
  8. 根据权利要求1所述的前列腺扩裂导管，其特征在于，所述主管直径为5-6cm，材质为PVC或PE，所述内囊和外囊的材质均为复合材料。
  9. 根据权利要求8所述的前列腺扩裂导管，其特征在于，所述内囊直径与所述外囊前段直径相同，外囊中段直径为2.5cm－4cm。
  10. 根据权利要求2所述的前列腺扩裂导管，其特征在于，所述内囊的充水量为20-50毫升，所述外囊的充水压强为0.3MPa。
PCT/CN2016/072130 2015-09-21 2016-01-26 一种前列腺扩裂导管 WO2017049823A1 (zh)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2017544819A JP2017537755A (ja) 2015-09-21 2016-01-26 前立腺拡張導管
KR1020177017815A KR20170088979A (ko) 2015-09-21 2016-01-26 전립선 확장 도관
US15/531,930 US20170340868A1 (en) 2015-09-21 2016-01-26 Prostate dilation catheter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201510602895.0 2015-09-21
CN201510602895.0A CN105079950A (zh) 2015-09-21 2015-09-21 一种新型前列腺扩裂导管

Publications (1)

Publication Number Publication Date
WO2017049823A1 true WO2017049823A1 (zh) 2017-03-30

Family

ID=54561851

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2016/072130 WO2017049823A1 (zh) 2015-09-21 2016-01-26 一种前列腺扩裂导管

Country Status (5)

Country Link
US (1) US20170340868A1 (zh)
JP (1) JP2017537755A (zh)
KR (1) KR20170088979A (zh)
CN (1) CN105079950A (zh)
WO (1) WO2017049823A1 (zh)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109701141A (zh) * 2019-01-14 2019-05-03 中国医学科学院肿瘤医院 定位前列腺与膀胱连接处的导尿管
CN112121288A (zh) * 2020-10-20 2020-12-25 常州市金坛区人民医院 一种持续性前列腺水囊扩张系统
CN114082008A (zh) * 2021-09-07 2022-02-25 四川大学华西医院 一种新型泌尿外科膀胱造瘘管

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105079950A (zh) * 2015-09-21 2015-11-25 北京优尼康通医疗科技有限公司 一种新型前列腺扩裂导管
CN107343980A (zh) * 2016-04-21 2017-11-14 青岛智辰生物科技有限公司 一种多腔道球囊导管
CN106581795B (zh) * 2016-12-28 2020-03-24 北京优尼康通医疗科技有限公司 内囊前移的复合柱状水囊前列腺扩裂导管的使用方法
CN107088260A (zh) * 2017-06-12 2017-08-25 广州优尼康通医疗科技有限公司 定位凸可调的复合柱状水囊前列腺扩裂导管
CN107174685A (zh) * 2017-06-22 2017-09-19 汪鑫 一种前列腺扩张管
CN107174677A (zh) * 2017-06-28 2017-09-19 九铭瑞华(北京)生物医学科技有限公司 一种导尿装置
CN107198811A (zh) * 2017-07-11 2017-09-26 广州优尼康通医疗科技有限公司 内囊前移的前列腺扩裂导管
CN107198815A (zh) * 2017-07-11 2017-09-26 广州优尼康通医疗科技有限公司 球部尿道可视化定位的前列腺扩裂管
KR102156619B1 (ko) 2018-06-01 2020-09-17 주식회사 나노메드 요도확장용 의료기구
CN109646793A (zh) * 2019-02-02 2019-04-19 江苏长寿棒科技有限公司 经尿道前列腺扩裂导管及其扩裂方法
CN109925589B (zh) * 2019-03-05 2021-09-21 江苏长寿棒科技有限公司 一种新型前列腺扩裂导管
CN110180075B (zh) * 2019-05-26 2022-02-11 靖璟 设防护端头的前列腺气囊扩张导管
CN111803780B (zh) * 2020-06-29 2022-02-11 中国人民解放军陆军军医大学第一附属医院 一种隧道式球囊
CN117224074B (zh) * 2023-09-28 2024-01-26 济南凯特工贸有限公司 可调节可视输尿管软镜通道鞘

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997028840A1 (en) * 1996-02-12 1997-08-14 Mentor Urology, Inc. Prostatic tissue expander
US6102929A (en) * 1994-09-15 2000-08-15 Mentor Urology, Inc. Prostatic tissue expander
CN201257219Y (zh) * 2008-07-22 2009-06-17 姜大磊 新型多腔高压水囊后尿道扩裂导管
CN102000384A (zh) * 2010-12-03 2011-04-06 北京优尼康通医疗科技有限公司 复合柱状水囊前列腺扩裂导管
CN202876065U (zh) * 2012-10-14 2013-04-17 刘加升 一种带定位囊的前列腺扩开导管
CN105079950A (zh) * 2015-09-21 2015-11-25 北京优尼康通医疗科技有限公司 一种新型前列腺扩裂导管
CN204932562U (zh) * 2015-09-21 2016-01-06 北京优尼康通医疗科技有限公司 一种新型前列腺扩裂导管

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3900033A (en) * 1973-03-07 1975-08-19 Ortho Pharma Corp Dilator for cervical canal
US5536252A (en) * 1994-10-28 1996-07-16 Intelliwire, Inc. Angioplasty catheter with multiple coaxial balloons
CN2399049Y (zh) * 1999-10-28 2000-10-04 山西省康健医用导管研究所 复合高压水囊前列腺扩张扩裂导管
JP2001198222A (ja) * 2000-01-17 2001-07-24 Sumitomo Bakelite Co Ltd 圧迫止血カテーテル
US8048101B2 (en) * 2004-02-25 2011-11-01 Femasys Inc. Methods and devices for conduit occlusion
US20060271092A1 (en) * 2005-05-27 2006-11-30 David Reed Balloon-in-balloon cervical canal dilator
US20080177127A1 (en) * 2006-12-19 2008-07-24 Donna Allan Asymmetric Radiation Dosing Devices and Methods for Brachytherapy
US8348890B2 (en) * 2011-03-01 2013-01-08 Sanovas, Inc. Nested balloon catheter for localized drug delivery
WO2014009809A1 (en) * 2012-07-09 2014-01-16 A.V. Medical Technologies, Ltd. Systems for blood vessel dilatation and visualization

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6102929A (en) * 1994-09-15 2000-08-15 Mentor Urology, Inc. Prostatic tissue expander
WO1997028840A1 (en) * 1996-02-12 1997-08-14 Mentor Urology, Inc. Prostatic tissue expander
CN201257219Y (zh) * 2008-07-22 2009-06-17 姜大磊 新型多腔高压水囊后尿道扩裂导管
CN102000384A (zh) * 2010-12-03 2011-04-06 北京优尼康通医疗科技有限公司 复合柱状水囊前列腺扩裂导管
CN202876065U (zh) * 2012-10-14 2013-04-17 刘加升 一种带定位囊的前列腺扩开导管
CN105079950A (zh) * 2015-09-21 2015-11-25 北京优尼康通医疗科技有限公司 一种新型前列腺扩裂导管
CN204932562U (zh) * 2015-09-21 2016-01-06 北京优尼康通医疗科技有限公司 一种新型前列腺扩裂导管

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109701141A (zh) * 2019-01-14 2019-05-03 中国医学科学院肿瘤医院 定位前列腺与膀胱连接处的导尿管
CN112121288A (zh) * 2020-10-20 2020-12-25 常州市金坛区人民医院 一种持续性前列腺水囊扩张系统
CN114082008A (zh) * 2021-09-07 2022-02-25 四川大学华西医院 一种新型泌尿外科膀胱造瘘管

Also Published As

Publication number Publication date
US20170340868A1 (en) 2017-11-30
KR20170088979A (ko) 2017-08-02
JP2017537755A (ja) 2017-12-21
CN105079950A (zh) 2015-11-25

Similar Documents

Publication Publication Date Title
WO2017049823A1 (zh) 一种前列腺扩裂导管
US3908637A (en) Rigid urethral instrument
US20060287570A1 (en) Endourethral device & method
CN203264017U (zh) 靶向扩张成形球囊导管
CN204932562U (zh) 一种新型前列腺扩裂导管
CN106581795B (zh) 内囊前移的复合柱状水囊前列腺扩裂导管的使用方法
CN107050624B (zh) 复合柱状水囊前列腺扩裂导管的使用方法
CN112190824A (zh) 一种多功能双球囊导尿管
CN207785590U (zh) 医用腔道内镜穿刺注液器
CN104415449A (zh) 膀胱冲洗防堵塞导尿管
CN208274818U (zh) 可视化定位的前列腺扩裂导管
CN207384587U (zh) 一种导尿管
CN107198815A (zh) 球部尿道可视化定位的前列腺扩裂管
CN205084187U (zh) 一种输尿管内置球囊扩张导管
CN104888338A (zh) 一种前列腺增生的球囊扩张导管
CN210170656U (zh) 一次性五腔双囊全可视超滑前列腺扩裂导管
CN210170657U (zh) 一次性四腔单囊全可视超滑前列腺扩裂导管
CN208065565U (zh) 带球囊的输尿管导管
CN212439678U (zh) 一种新型前列腺扩裂导管
CN205924121U (zh) 骶管留置针
CN111202916A (zh) 一种减轻超声治疗副反应的经直肠插入球囊装置
CN208927183U (zh) 一种男性用导丝引导的导尿管
CN212439677U (zh) 一种前列腺扩裂导管
CN210583330U (zh) 一种可视化前列腺扩裂器
CN212789404U (zh) 一种有窥视功能的前列腺扩张导管

Legal Events

Date Code Title Description
ENP Entry into the national phase

Ref document number: 2017544819

Country of ref document: JP

Kind code of ref document: A

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16847720

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 15531930

Country of ref document: US

ENP Entry into the national phase

Ref document number: 20177017815

Country of ref document: KR

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205A DATED 02/07/2018)

122 Ep: pct application non-entry in european phase

Ref document number: 16847720

Country of ref document: EP

Kind code of ref document: A1