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WO2016074647A1 - 子宫适形防粘连屏障装置及其使用方法 - Google Patents

子宫适形防粘连屏障装置及其使用方法 Download PDF

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Publication number
WO2016074647A1
WO2016074647A1 PCT/CN2015/094621 CN2015094621W WO2016074647A1 WO 2016074647 A1 WO2016074647 A1 WO 2016074647A1 CN 2015094621 W CN2015094621 W CN 2015094621W WO 2016074647 A1 WO2016074647 A1 WO 2016074647A1
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WO
WIPO (PCT)
Prior art keywords
expansion
liquid
contraction
capsule
adhesion
Prior art date
Application number
PCT/CN2015/094621
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English (en)
French (fr)
Inventor
段华
Original Assignee
段华
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
Priority claimed from CN201420679083.7U external-priority patent/CN204318873U/zh
Priority claimed from CN201410640564.1A external-priority patent/CN104436422A/zh
Priority claimed from CN201410640606.1A external-priority patent/CN104434277A/zh
Priority claimed from CN201420678162.6U external-priority patent/CN204319503U/zh
Priority claimed from CN201510763058.6A external-priority patent/CN105327442A/zh
Priority claimed from CN201520895407.5U external-priority patent/CN205163209U/zh
Application filed by 段华 filed Critical 段华
Publication of WO2016074647A1 publication Critical patent/WO2016074647A1/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
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • 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
    • 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
    • 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
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0815—Implantable devices for insertion in between organs or other soft tissues
    • A61B2090/0816—Implantable devices for insertion in between organs or other soft tissues for preventing adhesion
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1061—Balloon catheters with special features or adapted for special applications having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube

Definitions

  • the invention belongs to the technical field of medical instruments, and in particular relates to a uterine conformal anti-adhesion barrier device and a using method thereof.
  • Intrauterine adhesions are mainly due to uterine lining damage and scar formation caused by curettage, infection, is a common disease, frequently-occurring disease, especially prone to uterine surgery operation of pregnancy-related diseases, the incidence rate in such patients It is 30-40%.
  • intrauterine adhesions often occur in the clinic. Therefore, intrauterine adhesions are very common in China.
  • Intrauterine adhesions can cause menstrual flow, amenorrhea, infertility, severely affect the reproductive health of patients, and undermine the harmony and stability of the family and society.
  • there are many methods for preventing intrauterine adhesions at home and abroad mainly focusing on mechanical barriers and estrogens.
  • the Chinese patent document discloses a cloth-type uterus stent [application No.: 201310413884.9], which comprises a stent body, which is a biomimetic structure whose outer shape conforms to the uterus, and the stent body has an internal cavity therein.
  • a balloon is disposed in the inner cavity, and the balloon is in a full state, and is adapted to the shape of the internal cavity of the stent body, and the balloon connection is flooded a tube, the inner cavity is connected with a drug delivery tube, and the stent body is provided with a drug dispensing hole communicating with the inner cavity.
  • the above solution solves the problem that the existing barrier device cannot be applied to the adhesion site in the uterus to some extent, but the solution still has the following advantages: complicated structure, poor anti-adhesion effect, inconvenient operation, poor stability, and insufficient positioning. problem.
  • the object of the present invention is to provide a uterine conformal anti-adhesion barrier device with simple and reasonable structure and good stability in view of the above problems.
  • Another object of the present invention is to provide a method of using a uterine conformal anti-adhesion barrier device that is easy to operate and easy to implement in response to the above problems.
  • the sac is in an expanded state, it has a shape similar to that of the uterine cavity, and the tube body is further provided with a leakage preventing positioning mechanism under the anti-adhesive expansion and contraction capsule to prevent liquid leakage in the uterine cavity, and the anti-adhesion swell
  • the sac is connected with a first expansion and contraction control mechanism for controlling the expansion and contraction of the anti-adhesive expansion and contraction capsule.
  • the upper end of the tube body and the anti-adhesive expansion and contraction capsule are placed in the uterine cavity, and the positioning is realized by the leakage prevention positioning mechanism, and the liquid is input from the second liquid supply port and is outputted from the first liquid supply port into the uterine cavity, at the first
  • the anti-adhesive expansion and contraction capsule expands under the action of the expansion and contraction control mechanism. Because the anti-adhesive expansion and contraction capsule expands similarly to the shape of the uterine cavity, the liquid fills the inner wall of the uterine cavity, and the anti-adhesion effect is good, and the remaining liquid flows back from the first liquid-passing port.
  • the second liquid-passing port is discharged, and the leak-proof positioning mechanism can prevent liquid from leaking from the outside of the pipe body during the whole process, thereby avoiding waste of liquid and making the pipe body and the anti-adhesion expansion and contraction sac not easily escape from the uterine cavity.
  • the leak-proof positioning mechanism includes a leak-proof positioning pocket that is sleeved on the tube body, and the leakage-proof positioning capsule is connected with a third portion capable of controlling the expansion and contraction of the leak-proof positioning capsule.
  • Two expansion and contraction control mechanisms Obviously, the leak-proof positioning capsule is optimally disposed in the uterine cavity, that is, the second inflation-expanding control mechanism controls the expansion of the leak-proof positioning capsule to block the uterine cavity.
  • the leak-proof positioning capsule comprises a capsule which is cylindrical and sleeved on the tube body, and has a plurality of axially distributed arcuate convex rings on the outer wall of the capsule.
  • An arcuate annular groove is formed between the adjacent two arcuate convex rings.
  • a plurality of curved ring grooves enable the leak-proof positioning pocket to be securely positioned at the uterine cavity, and the anti-leakage effect is better.
  • the circumferential periphery of the arcuate ring groove is provided with at least one circumferential direction disposed on the leakage preventing positioning pocket and can prevent the arcuate ring groove circumference when the leakage preventing positioning pocket expands.
  • the circumferential inner side of the annular ferrule is bonded to the circumferential outer side of the arcuate ring groove by bonding or the circumferential direction of the annular ferrule and the curved ring groove
  • the outer side is connected in one piece.
  • the first expansion-contraction control mechanism includes a first passage axially disposed in the tubular body, the upper end of the first passage is in communication with the anti-adhesion expansion and contraction capsule, and the lower end is located
  • the second expansion and contraction control mechanism comprises a second passage axially disposed in the tubular body, the upper end of the second passage is in communication with the leakage prevention positioning pocket, and the lower end is located at the lower end of the tubular body.
  • the first passage and the second passage are disposed on the inner wall of the tubular body.
  • the first channel upper end side portion is provided with at least one first medium hole communicating with the anti-adhesion expansion and contraction capsule; and the second channel upper end side portion is provided with at least a second dielectric hole in communication with the leak-proof positioning pocket.
  • the first liquid passage and the second liquid passage communicate with each other through a liquid passage, and the liquid passage, the first passage and the second passage are both located in the tube. In vivo and independent of each other. Injecting fluid into the uterine cavity The body time and the first expansion and contraction control mechanism and the second expansion and contraction control mechanism do not interfere with each other when working, and the stability is good.
  • the lower end of the tubular body is provided with three independent branch pipes, and the liquid passage, the first passage and the second passage are respectively connected to one branch pipe, and at least one branch pipe is connected With control valve.
  • a control valve is provided on each of the branch pipes here to facilitate the steps.
  • the branch pipes are radially distributed and located on the same plane, and the branch pipes connected to the liquid passages are disposed centrally, and reinforcing plates are disposed between the inner ends of the adjacent two branch pipes;
  • the anti-adhesive expansion and contraction capsule and the leakage prevention positioning capsule are respectively made of a medical film material.
  • the structure makes the whole device have good stability and high strength.
  • the anti-adhesive expansion and contraction capsule and the leakage prevention positioning capsule are integrally connected with the tube body.
  • the above method for using the uterine conformal anti-adhesion barrier device is as follows: a method for using a uterine conformal anti-adhesion barrier device, characterized in that the adjustment method comprises the following steps: the method of using the method comprises the following steps : positioning is realized by a leak-proof positioning mechanism, and then liquid is input from the second liquid-passing port and outputted from the first liquid-passing port, and then the anti-adhesive expansion and contraction capsule is realized by the first expansion and contraction control mechanism to the anti-adhesion expansion and contraction capsule input medium.
  • the liquid is output through the first liquid passage port and the second liquid passage port, and the medium in the anti-adhesion expansion and contraction bladder is discharged through the first expansion and contraction control mechanism to realize the shrinkage of the anti-adhesion expansion and contraction capsule.
  • the leakage preventing positioning mechanism has the function of preventing leakage and positioning, and the expansion of the anti-adhesion expansion and contraction capsule enables the liquid to fill the entire uterine cavity, and the anti-adhesion effect is good, and the whole process is convenient to implement and convenient to operate.
  • the leak-proof positioning mechanism comprises a leakage-proof positioning pocket sleeved on the tube body, and the leakage-proof positioning capsule is connected with a leak-proof positioning capsule capable of controlling leakage prevention.
  • the contracted second expansion and contraction control mechanism realizes expansion or contraction of the leakage preventing positioning capsule by inputting or outputting a medium to the leakage preventing positioning capsule through the second expansion and contraction control mechanism. That is, the leak-proof positioning is performed by inputting a medium into the leak-proof positioning pocket to expand it.
  • the capsule is positioned at the uterine cavity and prevents fluid leakage.
  • the medium for inputting or outputting the first expansion and contraction control mechanism and the second expansion and contraction control mechanism is any one or more of gas, liquid and colloid.
  • the second fluid inlet and the liquid output by the first liquid outlet are composed of a liquid mixture including a gel, a medical amniotic membrane and an antibiotic.
  • the medium used herein is a liquid material, and the liquid input from the second liquid inlet 12 and outputted by the first liquid passage 11 can be replaced with other liquid materials which are non-toxic and harmless to the human body according to actual conditions.
  • the uterus conformal anti-adhesive barrier device and the method of using the same have the advantages of simple structure, convenient operation, convenient implementation, firm positioning during use, prevention of liquid leakage, and good anti-adhesion effect. , good stability and high strength.
  • Figure 1 is a schematic view of the structure provided by the present invention.
  • Figure 2 is a cross-sectional view of the present invention.
  • Figure 3 is an enlarged view of A in Figure 2.
  • Figure 4 is an enlarged view of B in Figure 2.
  • Figure 5 is an enlarged view of the portion C in Figure 2.
  • Fig. 6 is an enlarged view of the leakage preventing positioning mechanism of the second embodiment.
  • the uterine conformal anti-adhesive barrier device comprises a tube body 1, the upper end of the tube body 1 has a first liquid passage port 11, the lower end has a second liquid passage port 12, and the first liquid passage is provided.
  • the mouth 11 and the second liquid inlet 12 are connected to each other, and the outer end of the tube body 1 is sleeved with an anti-adhesion expansion and contraction capsule 2 and the upper end of the tube body 1 is penetrated through the anti-adhesion expansion and contraction capsule 2, and the anti-adhesion expansion and contraction capsule 2 is in an expanded state.
  • the tube body 1 is further provided with a leak-proof positioning mechanism 3 under the anti-adhesive expansion and contraction capsule 2 to prevent liquid leakage in the uterine cavity, and the anti-adhesion expansion and contraction capsule 2 is connected for control.
  • the liquid-passing port 12 is input and outputted from the first liquid-passing port 11 into the uterine cavity, and the anti-adhesive expansion and contraction sac 2 is expanded by the first expansion-contraction control mechanism 4, and the uterine cavity shape is expanded due to the expansion of the anti-adhesive sac.
  • the liquid is filled over the inner wall of the uterine cavity, and the anti-adhesion effect is good, and the remaining liquid flows back from the first liquid supply port 11 to the second liquid supply port 12 and Out, the whole process leakproof positioning mechanism 3 can prevent liquid leakage from an outside of the liquid tube, avoiding the waste such that the liquid and the tube 1 and the balloon dilations antiblocking departing from the uterine cavity 2 easy.
  • the leakage preventing positioning mechanism 3 in the embodiment includes a leakage preventing positioning bag 31 sleeved on the pipe body 1.
  • the leakage preventing positioning bag 31 is connected with a second expansion and contraction control mechanism capable of controlling the expansion and contraction of the leakage preventing positioning bag 31. 5.
  • the leakage preventing positioning capsule 31 is optimally disposed at the uterine cavity, that is, the second expansion and contraction control mechanism 5 controls the expansion of the leakage preventing positioning capsule 31 to block the uterine cavity.
  • the leakage preventing positioning bag 31 includes a capsule 311 which is cylindrical and sleeved on the tube body 1.
  • the outer wall of the capsule body 311 has a plurality of axially distributed arcuate convex rings 312, two adjacent arcs.
  • An arcuate annular groove 313 is formed between the convex rings 312, that is, a plurality of curved annular grooves 313 enable the leakage preventing positioning capsule 31 to be firmly positioned at the uterine cavity mouth, and the anti-leakage effect is better.
  • the first expansion and contraction control mechanism 4 herein includes a first passage 41 axially disposed in the tubular body 1, the upper end of the first passage 41 is in communication with the anti-adhesion expansion and contraction capsule 2, and the lower end is located at the lower end of the tubular body 1;
  • the expansion and contraction control mechanism 5 includes a second passage 51 axially disposed in the tubular body 1.
  • the upper end of the second passage 51 communicates with the leak-proof positioning pocket 31, and the lower end is located at the lower end of the tubular body 1, preferably, the first passage 41 here
  • the second passage 51 is correspondingly disposed on the inner wall of the pipe body 1.
  • the first liquid passage 11 and the second liquid passage 12 in the present embodiment communicate with each other through the liquid passage 13 , and the liquid passage 13 , the first passage 41 and the second passage 51 are both located in the pipe body 1 and mutually
  • the arrangement is independent, so that when the liquid is injected into the uterine cavity, the first expansion and contraction control mechanism 4 is operated and the second expansion and contraction control mechanism 5 is not interfered with each other, and the stability is good.
  • the upper end side of the first passage 41 is provided with at least one first medium hole 41a communicating with the anti-adhesion expansion and contraction capsule 2; and the upper end side of the second passage 51 is provided with at least one communication with the leakage prevention positioning pocket 31.
  • the second medium hole 51a is provided with at least one communication with the leakage prevention positioning pocket 31.
  • the lower end of the pipe body 1 is provided with three independent branch pipes 6, and the liquid passage 13, the first passage 41 and the second passage 51 are respectively connected to one branch pipe 6, and at least one branch pipe 6 is provided.
  • the control valve 7, preferably, a control valve 7 is provided on each of the branch pipes 6 here, which facilitates the various steps.
  • the control valve 7 on the liquid passage 13 adopts a ball valve
  • the control valve 7 on the first passage 41 and the second passage 51 adopts a check valve.
  • the branch pipes 6 are radially distributed and are located on the same plane, and the branch pipes 6 connected to the liquid passages 13 are disposed centrally, and the reinforcing plates 61 are disposed between the inner ends of the adjacent two branch pipes 6; the anti-adhesion expansion and contraction sacs 2 and the prevention
  • the leaky positioning capsules 31 are respectively made of a medical film material, which makes the whole device stable and high in strength.
  • the anti-adhesive expansion and contraction capsules 2 and the leakage preventing positioning capsules 31 are integrally connected to the tube body 1.
  • the method for using the uterine conformal anti-adhesion barrier device of the uterine conformal anti-adhesion barrier device comprises the steps of: positioning by the leak-proof positioning mechanism 3, and then inputting the liquid from the second liquid-passing port 12 and from the first pass Liquid port 11 output, and then pass the first
  • the expansion and contraction control mechanism 4 inputs the medium to the anti-adhesion expansion and contraction capsule 2 to realize the expansion of the anti-adhesion expansion and contraction capsule 2; when the use is completed, the liquid is output through the first liquid supply port 11 and the second liquid supply port 12, and passes through the first
  • the expansion and contraction control mechanism 4 discharges the medium in the anti-adhesive expansion and contraction capsule 2 to achieve the contraction of the anti-adhesive expansion and contraction capsule 2, and the leakage prevention positioning mechanism 3 has the function of preventing leakage and positioning, and the anti-adhesion expansion and contraction capsule 2
  • the expansion allows the liquid to fill the entire uterine cavity, the anti-adhesion effect is
  • the leakage preventing positioning mechanism 3 of the method comprises a leakage preventing positioning capsule 31 sleeved on the pipe body 1.
  • the leakage preventing positioning bag 31 is connected with a second expansion and contraction control mechanism 5 capable of controlling the expansion and contraction of the leakage preventing positioning bag 31,
  • the two expansion and contraction control mechanism 5 inputs or outputs a medium to the leakage preventing positioning capsule 31 to realize expansion or contraction of the leakage preventing positioning capsule 31, that is, by inserting a medium into the leakage preventing positioning pocket 31 to expand and thereby positioning the leakage preventing positioning capsule 31 at The mouth of the uterus can prevent liquid leakage.
  • the medium input or outputted by the first expansion and contraction control mechanism 4 and the second expansion and contraction control mechanism 5 herein is any one or more of gas, liquid and colloid;
  • the second liquid inlet 12 is input and is
  • the liquid outputted from a liquid outlet 11 is composed of a liquid mixture including a gel, a medical amniotic membrane and an antibiotic, wherein the medium is selected from a liquid material, and the second liquid inlet 12 is input therein and is output by the first liquid outlet 11.
  • the liquid can be replaced by other liquid materials that are non-toxic and harmless to the human body according to the actual situation.
  • At least one circumferential direction of the arcuate annular groove 313 is disposed on the leakage preventing positioning pocket 31 and can prevent the arcuate annular groove 313 from being extended when the leakage preventing positioning capsule 31 is inflated.
  • the circumferential ferrule 8 is circumferentially joined to the circumferential outer side of the arcuate ring groove 313 by bonding or the circumferential ferrule 8 and the circumferential outer side of the arcuate ring groove 313 are integrally formed.
  • each of the arcuate ring grooves 313 is provided with an annular ferrule 8 on the circumferential periphery.
  • the annular ferrule 8 herein is made of any one of a rubber material, a silicone material and a latex material.
  • the annular ferrule 8 can prevent the arcuate ring groove 313 from appearing when the leakage preventing positioning pocket 31 is inflated.
  • the phenomenon of the transition to the transition ensures the integrity of the shape of the arcuate ring groove 313 and the curved collar 312 in the expanded state, and at the same time improves the positioning and leakage prevention effect of the leakproof positioning pocket 31.
  • the tube body 1, the first liquid supply port 11, the second liquid supply port 12, the liquid passage 13, the anti-adhesion expansion and contraction capsule 2, the leakage prevention positioning mechanism 3, the leakage prevention positioning capsule 31, and the capsule are used more frequently.
  • the terms of the hole 51a, the branch pipe 6, the reinforcing plate 61, the control valve 7, the annular ferrule 8, etc. do not exclude the possibility of using other terms. These terms are only used to describe and explain the nature of the invention more conveniently; it is to be construed that any additional limitation is inconsistent with the spirit of the invention.

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Abstract

一种子宫适形防粘连屏障装置及其使用方法，解决了现有防粘连屏障装置定位不够牢固等问题。该装置包括管体（1），该管体（1）的上端具有第一通液口（11），下端具有第二通液口（12），且第一通液口（11）和第二通液口（12）相互连通，管体（1）上端外围套设有防粘连胀缩囊（2）且管体（1）上端贯穿防粘连胀缩囊（2），防粘连胀缩囊（2）处于膨胀状态时具有与宫腔相似的外形，在管体（1）上还设有位于防粘连胀缩囊（2）下方且能防止宫腔内的液体渗漏的防漏定位机构（3），防粘连胀缩囊（2）连接有用于控制防粘连胀缩囊（2）胀缩的第一胀缩控制机构（4）。子宫适形防粘连屏障装置及其使用方法的优点在于：结构简单，操作方便，便于实施，使用时定位牢固，具有防止液体渗漏的作用，防粘连效果好，稳定性好，强度高。

Description

子宫适形防粘连屏障装置及其使用方法 技术领域
本发明属于医疗器械技术领域，尤其是涉及一种子宫适形防粘连屏障装置及其使用方法。
背景技术
宫腔粘连主要是由于刮宫、感染所致子宫内膜基底层损伤和瘢痕形成，是一种常见病、多发病，特别容易发生于妊娠相关疾病的宫腔手术操作，在这类患者中发病率为30-40％。此外，不明原因的宫腔粘连在临床也常有出现。因此，宫腔粘连在我国非常常见。宫腔粘连可造成患者月经量减少、闭经、不孕，严重影响患者生殖健康，破坏了家庭和社会的和谐、稳定。目前国内、外预防宫腔粘连方法有很多，主要集中于机械屏障、雌激素素类药物。临床实践效果不理想，特别是对于重度粘连，粘连分离术后再粘连发生率在60％以上，例如机械屏障的方式有放置节育环、隔离膜片、子宫支架等，这些方式存在诸多缺陷，例如，防粘连效果差，操作不便，机械屏障置入宫颈时需要进行极大地扩展宫颈口，造成宫颈撕裂损伤，不易恢复，不能针对子宫内易发生粘连部位给药。
为了解决现有技术存在的问题，人们进行了长期的探索，提出了各式各样的解决方案。例如，中国专利文献公开了一种布药型子宫支架[申请号：201310413884.9]，包括支架本体，所述支架本体为外部形状与子宫相适应的仿生结构，所述支架本体内具有内部空腔，所述内部空腔中设有球囊，所述球囊在充满状态下，与所述支架本体的内部空腔的形状相适应，所述球囊连接有充斥 管，所述内部空腔连接有给药管，所述支架本体上设有与所述内部空腔连通的布药孔。
上述方案在一定程度上解决了现有屏障装置不能针对子宫内易发生粘连部位给药的问题，但是该方案依然存在着：结构复杂，防粘连效果差，操作不便，稳定性差，定位不够牢固的问题。
发明内容
本发明的目的是针对上述问题，提供一种结构简单合理，稳定性好的子宫适形防粘连屏障装置。
本发明的另一个目的是针对上述问题，提供一种操作方便，便于实施的子宫适形防粘连屏障装置的使用方法。
为达到上述目的，本发明采用了下列技术方案：本子宫适形防粘连屏障装置，包括管体，该管体的上端具有第一通液口，下端具有第二通液口，且第一通液口和第二通液口相互连通，其特征在于，所述的管体上端外围套设有防粘连胀缩囊且管体上端贯穿所述的防粘连胀缩囊，所述的防粘连胀缩囊处于膨胀状态时具有与宫腔相似的外形，在管体上还设有位于防粘连胀缩囊下方且能防止宫腔内的液体渗漏的防漏定位机构，所述的防粘连胀缩囊连接有用于控制防粘连胀缩囊胀缩的第一胀缩控制机构。
使用时管体上端及其防粘连胀缩囊置于宫腔内，通过防漏定位机构实现定位，液体由第二通液口输入并自第一通液口输出至宫腔内，在第一胀缩控制机构作用下防粘连胀缩囊膨胀，由于防粘连胀缩囊膨胀时与宫腔外形相似使得液体布满整个宫腔内壁，防粘连效果好，剩余液体由第一通液口流回第二通液口并排出，整个过程中防漏定位机构能防止液体从管体外侧液体渗漏，避免了液体的浪费且使得管体与防粘连胀缩囊不易脱离宫腔。
在上述的子宫适形防粘连屏障装置中，所述的防漏定位机构包括套设于管体的防漏定位囊，所述的防漏定位囊连接有能控制防漏定位囊胀缩的第二胀缩控制机构。显然，这里的防漏定位囊设置在宫腔口时效果最佳，即通过第二胀缩控制机构控制防漏定位囊膨胀使其将宫腔口封堵。
在上述的子宫适形防粘连屏障装置中，所述的防漏定位囊包括呈筒状且套固在管体上的囊体，在囊体外壁具有若干轴向分布的弧形凸环，相邻的两个弧形凸环之间形成弧形环槽。多个弧形环槽能使防漏定位囊牢固地定位在宫腔口，且防渗漏效果更好。
在上述的子宫适形防粘连屏障装置中，所述的弧形环槽周向外围设有至少一个周向设置在防漏定位囊上且当防漏定位囊膨胀时能防止弧形环槽周向膨胀的环形箍圈。
在上述的子宫适形防粘连屏障装置中，所述的环形箍圈周向内侧通过粘接方式与弧形环槽的周向外侧相连或者所述的环形箍圈与弧形环槽的周向外侧连为一体式结构。
在上述的子宫适形防粘连屏障装置中，所述的第一胀缩控制机构包括轴向设置在管体内的第一通道，所述的第一通道上端与防粘连胀缩囊连通，下端位于管体下端；所述的第二胀缩控制机构包括轴向设置在管体内的第二通道，所述的第二通道上端与防漏定位囊连通，下端位于管体下端。优选地，这里的第一通道与第二通道对应设置在管体的内壁上。
在上述的子宫适形防粘连屏障装置中，所述的第一通道上端侧部设有至少一个与防粘连胀缩囊连通的第一介质孔；所述的第二通道上端侧部设有至少一个与防漏定位囊连通的第二介质孔。
在上述的子宫适形防粘连屏障装置中，所述的第一通液口和第二通液口通过通液通道相互连通，所述的通液通道、第一通道和第二通道均位于管体内且相互独立设置。使得向宫腔内注入液 体时和第一胀缩控制机构工作时以及第二胀缩控制机构工作时相互之间互不干扰，稳定性好。
在上述的子宫适形防粘连屏障装置中，所述的管体下端设有三根相互独立的支管，且通液通道、第一通道和第二通道分别与一根支管相连，至少一根支管上设有控制阀。优选地，这里的每一根支管上均设置一个控制阀，这样便于各个步骤的进行。
在上述的子宫适形防粘连屏障装置中，所述的支管呈放射状分布且位于同一平面上，与通液通道相连的支管居中设置，相邻的两根支管内端之间设有加强板；所述的防粘连胀缩囊和防漏定位囊分别由医用膜材料制成。该结构使得整个装置稳定性好，强度高，优选地，这里的防粘连胀缩囊与防漏定位囊均与管体连为一体。
上述的子宫适形防粘连屏障装置的使用方法如下所述：子宫适形防粘连屏障装置的使用方法，其特征在于，本调整方法包括下述步骤：其特征在于，本使用方法包括下述步骤：通过防漏定位机构实现定位，然后将液体由第二通液口输入并自第一通液口输出，再通过第一胀缩控制机构向防粘连胀缩囊输入介质实现防粘连胀缩囊的膨胀；当使用完毕后，通过第一通液口和第二通液口将液体输出，通过第一胀缩控制机构将防粘连胀缩囊中的介质排出实现防粘连胀缩囊的收缩。该方法中防漏定位机构具有防止渗漏与定位的作用，防粘连胀缩囊的膨胀使得液体能布满整个宫腔，防粘连效果好，且整个过程便于实施，操作方便。
在上述的子宫适形防粘连屏障装置的使用方法中，所述的防漏定位机构包括套设于管体的防漏定位囊，所述的防漏定位囊连接有能控制防漏定位囊胀缩的第二胀缩控制机构，通过第二胀缩控制机构向防漏定位囊输入或输出介质实现防漏定位囊的膨胀或收缩。即通过向防漏定位囊内输入介质使其膨胀从而将防漏定位 囊定位在宫腔口，且能防止液体渗漏。
在上述的子宫适形防粘连屏障装置的使用方法中，所述的第一胀缩控制机构和第二胀缩控制机构输入或输出的介质为气体、液体与胶体中的任意一种或多种；所述的第二通液口输入且由第一通液口输出的液体由包括凝胶、医用羊膜和抗生素在内的液态混合物构成。这里的介质选用液体材料，这里的第二通液口12输入且由第一通液口11输出的液体可以根据实际情况选择其他对人体无毒无害的液态材料进行替代。
与现有的技术相比，本子宫适形防粘连屏障装置及其使用方法的优点在于：结构简单，操作方便，便于实施，使用时定位牢固，具有防止液体渗漏的作用，防粘连效果好，稳定性好，强度高。
附图说明
图1为本发明提供的结构示意图。
图2为本发明提供的剖视图。
图3为图2中A处的放大图。
图4为图2中B处的放大图。
图5为图2中C处的放大图。
图6为实施例2的防漏定位机构的放大图。
图中，管体1、第一通液口11、第二通液口12、通液通道13、防粘连胀缩囊2、防漏定位机构3、防漏定位囊31、囊体311、弧形凸环312、弧形环槽313、第一胀缩控制机构4、第一通道41、第一介质孔41a、第二胀缩控制机构5、第二通道51、第二介质孔51a、支管6、加强板61、控制阀7、环形箍圈8。
具体实施方式
下面结合附图和具体实施方式对本发明做进一步详细的说明。
实施例1：
如图1-5所示，本子宫适形防粘连屏障装置，包括管体1，该管体1的上端具有第一通液口11，下端具有第二通液口12，且第一通液口11和第二通液口12相互连通，管体1上端外围套设有防粘连胀缩囊2且管体1上端贯穿防粘连胀缩囊2，防粘连胀缩囊2处于膨胀状态时具有与宫腔相似的外形，在管体1上还设有位于防粘连胀缩囊2下方且能防止宫腔内的液体渗漏的防漏定位机构3，防粘连胀缩囊2连接有用于控制防粘连胀缩囊2胀缩的第一胀缩控制机构4，使用时管体1上端及其防粘连胀缩囊2置于宫腔内，通过防漏定位机构3实现定位，液体由第二通液口12输入并自第一通液口11输出至宫腔内，在第一胀缩控制机构4作用下防粘连胀缩囊2膨胀，由于防粘连胀缩囊2膨胀时与宫腔外形相似使得液体布满整个宫腔内壁，防粘连效果好，剩余液体由第一通液口11流回第二通液口12并排出，整个过程中防漏定位机构3能防止液体从管体1外侧液体渗漏，避免了液体的浪费且使得管体1与防粘连胀缩囊2不易脱离宫腔。
优选地，本实施例中的防漏定位机构3包括套设于管体1的防漏定位囊31，防漏定位囊31连接有能控制防漏定位囊31胀缩的第二胀缩控制机构5，显然，这里的防漏定位囊31设置在宫腔口时效果最佳，即通过第二胀缩控制机构5控制防漏定位囊31膨胀使其将宫腔口封堵。其中，这里的防漏定位囊31包括呈筒状且套固在管体1上的囊体311，在囊体311外壁具有若干轴向分布的弧形凸环312，相邻的两个弧形凸环312之间形成弧形环槽313，即多个弧形环槽313能使防漏定位囊31牢固地定位在宫腔口，且防渗漏效果更好。
进一步地，这里的第一胀缩控制机构4包括轴向设置在管体1内的第一通道41，第一通道41上端与防粘连胀缩囊2连通，下端位于管体1下端；第二胀缩控制机构5包括轴向设置在管体1内的第二通道51，第二通道51上端与防漏定位囊31连通，下端位于管体1下端，优选地，这里的第一通道41与第二通道51对应设置在管体1的内壁上。其中，本实施例中的第一通液口11和第二通液口12通过通液通道13相互连通，通液通道13、第一通道41和第二通道51均位于管体1内且相互独立设置，这样使得向宫腔内注入液体时和第一胀缩控制机构4工作时以及第二胀缩控制机构5工作时相互之间互不干扰，稳定性好。具体地，第一通道41上端侧部设有至少一个与防粘连胀缩囊2连通的第一介质孔41a；所述的第二通道51上端侧部设有至少一个与防漏定位囊31连通的第二介质孔51a。
更进一步地，这里的管体1下端设有三根相互独立的支管6，且通液通道13、第一通道41和第二通道51分别与一根支管6相连，至少一根支管6上设有控制阀7，优选地，这里的每一根支管6上均设置一个控制阀7，这样便于各个步骤的进行。其中，通液通道13上的控制阀7采用球阀，第一通道41和第二通道51上的控制阀7采用单向阀。这里的支管6呈放射状分布且位于同一平面上，与通液通道13相连的支管6居中设置，相邻的两根支管6内端之间设有加强板61；防粘连胀缩囊2和防漏定位囊31分别由医用膜材料制成，该结构使得整个装置稳定性好，强度高，优选地，这里的防粘连胀缩囊2与防漏定位囊31均与管体1连为一体。
本子宫适形防粘连屏障装置的子宫适形防粘连屏障装置的使用方法，包括下述步骤：通过防漏定位机构3实现定位，然后将液体由第二通液口12输入并自第一通液口11输出，再通过第一 胀缩控制机构4向防粘连胀缩囊2输入介质实现防粘连胀缩囊2的膨胀；当使用完毕后，通过第一通液口11和第二通液口12将液体输出，通过第一胀缩控制机构4将防粘连胀缩囊2中的介质排出实现防粘连胀缩囊2的收缩，该方法中防漏定位机构3具有防止渗漏与定位的作用，防粘连胀缩囊2的膨胀使得液体能布满整个宫腔，防粘连效果好，且整个过程便于实施，操作方便。
本方法中的防漏定位机构3包括套设于管体1的防漏定位囊31，防漏定位囊31连接有能控制防漏定位囊31胀缩的第二胀缩控制机构5，通过第二胀缩控制机构5向防漏定位囊31输入或输出介质实现防漏定位囊31的膨胀或收缩，即通过向防漏定位囊31内输入介质使其膨胀从而将防漏定位囊31定位在宫腔口，且能防止液体渗漏。具体地，这里的第一胀缩控制机构4和第二胀缩控制机构5输入或输出的介质为气体、液体与胶体中的任意一种或多种；第二通液口12输入且由第一通液口11输出的液体由包括凝胶、医用羊膜和抗生素在内的液态混合物构成，这里的介质选用液体材料，这里的第二通液口12输入且由第一通液口11输出的液体可以根据实际情况选择其他对人体无毒无害的液态材料进行替代。
实施例2：
如图6所示，本实施例中，弧形环槽313周向外围设有至少一个周向设置在防漏定位囊31上且当防漏定位囊31膨胀时能防止弧形环槽313周向膨胀的环形箍圈8。环形箍圈8周向内侧通过粘接方式与弧形环槽313的周向外侧相连或者环形箍圈8与弧形环槽313的周向外侧连为一体式结构。本实施例中，每个弧形环槽313周向外围分别设置一个环形箍圈8。优选地，这里的环形箍圈8由橡胶材料、硅胶材料与乳胶材料中的任意一种材料制成。环形箍圈8能避免防漏定位囊31膨胀时弧形环槽313出现周 向过渡膨胀的现象，这样保证了防漏定位囊31在膨胀状态下时弧形环槽313和弧形凸环312形态的完整性，同时提高了防漏定位囊31的定位与防泄漏效果。
本文中所描述的具体实施例仅仅是对本发明精神作举例说明。本发明所属技术领域的技术人员可以对所描述的具体实施例做各种各样的修改或补充或采用类似的方式替代，但并不会偏离本发明的精神或者超越所附权利要求书所定义的范围。
尽管本文较多地使用了管体1、第一通液口11、第二通液口12、通液通道13、防粘连胀缩囊2、防漏定位机构3、防漏定位囊31、囊体311、弧形凸环312、弧形环槽313、第一胀缩控制机构4、第一通道41、第一介质孔41a、第二胀缩控制机构5、第二通道51、第二介质孔51a、支管6、加强板61、控制阀7、环形箍圈8等术语，但并不排除使用其它术语的可能性。使用这些术语仅仅是为了更方便地描述和解释本发明的本质；把它们解释成任何一种附加的限制都是与本发明精神相违背的。

Claims (13)

  1. 一种子宫适形防粘连屏障装置，包括管体(1)，该管体(1)的上端具有第一通液口(11)，下端具有第二通液口(12)，且第一通液口(11)和第二通液口(12)相互连通，其特征在于，所述的管体(1)上端外围套设有防粘连胀缩囊(2)且管体(1)上端贯穿所述的防粘连胀缩囊(2)，所述的防粘连胀缩囊(2)处于膨胀状态时具有与宫腔相似的外形，在管体(1)上还设有位于防粘连胀缩囊(2)下方且能防止宫腔内的液体渗漏的防漏定位机构(3)，所述的防粘连胀缩囊(2)连接有用于控制防粘连胀缩囊(2)胀缩的第一胀缩控制机构(4)。
  2. 根据权利要求1所述的子宫适形防粘连屏障装置，其特征在于，所述的防漏定位机构(3)包括套设于管体(1)的防漏定位囊(31)，所述的防漏定位囊(31)连接有能控制防漏定位囊(31)胀缩的第二胀缩控制机构(5)。
  3. 根据权利要求2所述的子宫适形防粘连屏障装置，其特征在于，所述的防漏定位囊(31)包括呈筒状且套固在管体(1)上的囊体(311)，在囊体(311)外壁具有若干轴向分布的弧形凸环(312)，相邻的两个弧形凸环(312)之间形成弧形环槽(313)。
  4. 根据权利要求3所述的子宫适形防粘连屏障装置，其特征在于，所述的弧形环槽(313)周向外围设有至少一个周向设置在防漏定位囊(31)上且当防漏定位囊(31)膨胀时能防止弧形环槽(313)周向膨胀的环形箍圈(8)。
  5. 根据权利要求4所述的子宫适形防粘连屏障装置，其特征在于，所述的环形箍圈(8)周向内侧通过粘接方式与弧形环槽(313)的周向外侧相连或者所述的环形箍圈(8)与弧形环槽(313)的周向外侧连为一体式结构。
  6. 根据权利要求3或4或5所述的子宫适形防粘连屏障装置，其特征在于，所述的第一胀缩控制机构(4)包括轴向设置在管体(1)内的第一通道(41)，所述的第一通道(41)上端与防粘连 胀缩囊(2)连通，下端位于管体(1)下端；所述的第二胀缩控制机构(5)包括轴向设置在管体(1)内的第二通道(51)，所述的第二通道(51)上端与防漏定位囊(31)连通，下端位于管体(1)下端。
  7. 根据权利要求6所述的子宫适形防粘连屏障装置，其特征在于，所述的第一通道(41)上端侧部设有至少一个与防粘连胀缩囊(2)连通的第一介质孔(41a)；所述的第二通道(51)上端侧部设有至少一个与防漏定位囊(31)连通的第二介质孔(51a)。
  8. 根据权利要求6所述的子宫适形防粘连屏障装置，其特征在于，所述的第一通液口(11)和第二通液口(12)通过通液通道(13)相互连通，所述的通液通道(13)、第一通道(41)和第二通道(51)均位于管体(1)内且相互独立设置。
  9. 根据权利要求8所述的子宫适形防粘连屏障装置，其特征在于，所述的管体(1)下端设有三根相互独立的支管(6)，且通液通道(13)、第一通道(41)和第二通道(51)分别与一根支管(6)相连，至少一根支管(6)上设有控制阀(7)。
  10. 根据权利要求9所述的子宫适形防粘连屏障装置，其特征在于，所述的支管(6)呈放射状分布且位于同一平面上，与通液通道(13)相连的支管(6)居中设置，相邻的两根支管(6)内端之间设有加强板(61)；所述的防粘连胀缩囊(2)和防漏定位囊(31)分别由医用膜材料制成。
  11. 一种根据权利要求1-10中任意一项所述的子宫适形防粘连屏障装置的使用方法，其特征在于，本使用方法包括下述步骤：通过防漏定位机构(3)实现定位，然后将液体由第二通液口(12)输入并自第一通液口(11)输出，再通过第一胀缩控制机构(4)向防粘连胀缩囊(2)输入介质实现防粘连胀缩囊(2)的膨胀；当使用完毕后，通过第一通液口(11)和第二通液口(12)将液体输出，通过第一胀缩控制机构(4)将防粘连胀缩囊(2)中的 介质排出实现防粘连胀缩囊(2)的收缩。
  12. 根据权利要求11所述的子宫适形防粘连屏障装置的使用方法，其特征在于，所述的防漏定位机构(3)包括套设于管体(1)的防漏定位囊(31)，所述的防漏定位囊(31)连接有能控制防漏定位囊(31)胀缩的第二胀缩控制机构(5)，通过第二胀缩控制机构(5)向防漏定位囊(31)输入或输出介质实现防漏定位囊(31)的膨胀或收缩。
  13. 根据权利要求12所述的子宫适形防粘连屏障装置的使用方法，其特征在于，所述的第一胀缩控制机构(4)和第二胀缩控制机构(5)输入或输出的介质为气体、液体与胶体中的任意一种或多种；所述的第二通液口(12)输入且由第一通液口(11)输出的液体由包括凝胶、医用羊膜和抗生素在内的液态混合物构成。
PCT/CN2015/094621 2014-11-13 2015-11-13 子宫适形防粘连屏障装置及其使用方法 WO2016074647A1 (zh)

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CN201420679083.7 2014-11-13
CN201410640564.1A CN104436422A (zh) 2014-11-13 2014-11-13 宫腔防粘连屏障系统
CN201410640606.1A CN104434277A (zh) 2014-11-13 2014-11-13 子宫适形防粘连屏障装置及其使用方法
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CN201420678162.6U CN204319503U (zh) 2014-11-13 2014-11-13 宫腔防粘连屏障系统
CN201510763058.6A CN105327442A (zh) 2015-11-10 2015-11-10 子宫适形防粘连屏障装置及其使用方法
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CN201520895407.5U CN205163209U (zh) 2015-11-11 2015-11-11 子宫适形防粘连屏障系统的防漏定位结构
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