CN107951550A - A kind of degradable inner membrane of uterine cavity implant system - Google Patents

A kind of degradable inner membrane of uterine cavity implant system Download PDF

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Publication number
CN107951550A
CN107951550A CN201711340775.3A CN201711340775A CN107951550A CN 107951550 A CN107951550 A CN 107951550A CN 201711340775 A CN201711340775 A CN 201711340775A CN 107951550 A CN107951550 A CN 107951550A
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China
Prior art keywords
implant
uterine cavity
inner membrane
implant system
matrix
Prior art date
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Withdrawn
Application number
CN201711340775.3A
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Chinese (zh)
Inventor
夏佩佩
魏征
谢建
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Yi Purun (shanghai) Biological Technology Co Ltd
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Yi Purun (shanghai) Biological Technology Co Ltd
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Priority to CN201711340775.3A priority Critical patent/CN107951550A/en
Publication of CN107951550A publication Critical patent/CN107951550A/en
Withdrawn legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42Gynaecological or obstetrical instruments or methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42Gynaecological or obstetrical instruments or methods
    • A61B2017/4216Operations on uterus, e.g. endometrium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/14Female reproductive, genital organs
    • A61M2210/1433Uterus

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Medical Informatics (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Reproductive Health (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Medicinal Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)
  • Prostheses (AREA)

Abstract

The present invention relates to a kind of degradable inner membrane of uterine cavity implant system, including delivery pipe, push rod and implant, at least part push rod is contained in delivery pipe, implant is contained in delivery pipe and receives the promotion of push rod in the first state, implant is the membranaceous or laminated structure with medicine, implant includes the medicine of the matrix and load of biodegradable material on the substrate, and the through hole for connecting membranaceous or laminated structure both sides is provided with matrix.Degradable inner membrane of uterine cavity implant system according to the present invention, the commitment positions being placed in implant by means of push rod in uterine cavity body, the uterine veil of adhesion is isolated by the matrix of implant and supporting role, the inflammation and wound face on uterus surface are effectively repaired by the medicine of implant, wherein, which alleviates due to being taken out without the later stage and operates the pain caused by sufferer repeatedly.

Description

A kind of degradable inner membrane of uterine cavity implant system
Technical field
The present invention relates to uterine cavity implantation instrument, relates more specifically to a kind of degradable inner membrane of uterine cavity implant system.
Background technology
Occurring for women Asherman's syndrom may be with the pregnant or non-pregnant factor of uteroventral operation history, and operation inflammatory factor Related etc. reason, Asherman's syndrom brings the even infertile pain of menstrual disorder directly to women.In order to be carried out to Asherman's syndrom Treatment, the means of the prior art are often complex and heavy financial burden is brought to patient.
The content of the invention
In order to solve the problems, such as the high cost of above-mentioned treatment Asherman's syndrom existing in the prior art, the present invention is intended to provide A kind of degradable inner membrane of uterine cavity implant system.
Degradable inner membrane of uterine cavity implant system of the present invention, including delivery pipe, push rod and implant, at least partly Push rod is contained in delivery pipe, and implant is contained in delivery pipe and receives the promotion of push rod in the first state, and implant is Membranaceous or laminated structure with medicine, implant include the medicine of the matrix and load of biodegradable material on the substrate, base The through hole for connecting membranaceous or laminated structure both sides is provided with matter.
The delivery pipe is circular tube structure, its madial wall is formed as step wall and limits the major diameter cavity of connection and small Diameter cavity.
Push rod is straight-bar structure, including the first enlarged diameter section, reduced diameter section and the second enlarged diameter section, wherein, reduced diameter section Between the first enlarged diameter section and the second enlarged diameter section, and the first enlarged diameter section is contained in major diameter cavity and coordinates.
Implant is ▽ types, Y types, orType.
Matrix is the gelatin film or independent gelatin film being supported on degradable skeleton.
Degradable skeleton is V-type.
Through hole is with the evenly spaced distribution of 2mm-3mm.
A diameter of 2mm-3mm of through hole.
- 7 exhausting hole of 5 row is set in matrix.
Indomethacin joint is blended for 17- β estradiol in medicine;Or single 17- β estradiol.
The daily burst size of medicine is 20-200 μ g.
Drug distribution is in the inside of matrix.
Implant, is placed in uterine cavity body by degradable inner membrane of uterine cavity implant system according to the present invention by means of push rod Commitment positions, the uterine veil of adhesion is isolated by the matrix of implant and supporting role, passes through the medicine of implant Inflammation and wound face to uterus surface are effectively repaired, wherein, which not only can be at 0.5 to 2 Month deenergized period interior orientation quantitatively slowly into uterine cavity wound face and inflammation administration with carry out continue and effectively repair with Solve the problems, such as Asherman's syndrom, and alleviate due to being taken out without the later stage and operate the pain caused by sufferer repeatedly.
Brief description of the drawings
Fig. 1 is the schematic perspective view of inner membrane of uterine cavity implant system degradable according to the present invention;
Fig. 2 is the schematic cross-sectional view of inner membrane of uterine cavity implant system degradable according to the present invention;
Fig. 3 shows the implant in Fig. 1;
Fig. 4 is the schematic diagram of another implant according to the present invention.
Embodiment
Below in conjunction with the accompanying drawings, presently preferred embodiments of the present invention is provided, and is described in detail.
Fig. 1-Fig. 2 shows inner membrane of uterine cavity implant system degradable according to the present invention, including delivery pipe 1,2 and of push rod Implant 3.In the present embodiment, delivery pipe 1 is circular tube structure, its madial wall is formed as step wall and limits the big of connection Diameter cavity 11 and minor diameter cavity 12.Push rod 2 is straight-bar structure, including the first enlarged diameter section 21, reduced diameter section 22 and second Enlarged diameter section 23, wherein, reduced diameter section 22 is between the first enlarged diameter section 21 and the second enlarged diameter section 23, and the first major diameter The diameter of section 21 is slightly less than the second enlarged diameter section 23.In the present embodiment, which is contained in major diameter cavity Coordinate in 11.Implant 3 is the membranaceous or laminated structure with medicine, it is contained in major diameter cavity 11 and can pushing away in push rod 2 Released under dynamic from delivery pipe 1.
During specifically used, the step wall of the first enlarged diameter section 21 of push rod 2 towards delivery pipe 1 is drawn first Go out so that the first enlarged diameter section 21 of push rod 2 in the major diameter cavity 11 against the step surface of delivery pipe 1, then will plant Enter thing 3 to be positioned in the major diameter cavity 11 of delivery pipe 1, the inner membrane of uterine cavity implant system is next arranged at appropriate position Put, promote push rod 2 towards implant 3 so that push rod 2 promotes the commitment positions that implant 3 is arrived in uterine cavity body, and can be with medicine Thing discharges.
The implant 3 is up-side down triangle, i.e. ▽ types.In fact, according to the profile in uterus, which can also basis Need to be adjusted to Y types orType etc..
The implant 3 includes the medicine of matrix and load on the substrate.So, on the one hand, the matrix of implant 3 can be with The uterine veil of adhesion is isolated and supporting role, on the other hand, the medicine of implant 3 can to the inflammation on uterus surface and Wound face is effectively repaired.
Matrix is biodegradable material.Preferably, in the period of 0.5~2 month of implant 3 after the implantation periodically Degraded, is not required to take out.In this way, not only 0.5 to 2 months deenergized period interior orientation quantitatively slowly into uterine cavity wound face and Inflammation administration is continued with carrying out and effectively repaired to solve the problems, such as Asherman's syndrom, and alleviate to operate repeatedly to make sufferer Into pain.
In one embodiment, the matrix of implant 3 is the gelatin film 32 being supported on degradable skeleton 31, such as Fig. 3 institutes Show.Wherein, which is rendered as V-type, to be supported to gelatin film 32, prevents gelatin film 32 in implantation process With the curling after implantation.In another embodiment, the matrix of implant 3 can be omitted degradable skeleton 31 and only by gelatin Film 32 is formed, as shown in Figure 4.
The degradable skeleton 31 of implant 3 can be formed by any degradation material, include but not limited to polylactic acid (polylactic acid, PLA), l-polylactic acid (polyLlactic acid, PLLA or LPLA), polyglycolic acid/polylactic acid Copolymer (polyglycolic acid/polylactic acid, PGLA), polycaprolactone (polycaprolactone, PCL), polyhydroxybutyrate valerate (polyhydroxylbutyrate valerate, PHBV), polyacetylglutamic acid (polyacetylglutamicacid, PAGA), polyorthoesters (polyorthoesters, POE) and polyethylene glycol oxide/polybutene Copolymer (polyethylene oxide/polybutylene terephthalate, PEO/PBTP), polydioxanone (poly-p-dioxanone, PPDO), poly butylene succinate (Poly (butylene succinate), PBS), the poly- last of the ten Heavenly stems two Acid glyceride (poly (glycerol sebacate), PGS), chitosan, polyvinyl alcohol (Poly Vinyl Alcoho, PVA), And the copolymer or blend of above-mentioned material, and its homologue.
Through hole 321 is provided with the gelatin film 32 of implant 3, it connects the both sides of film.Preferably, the through hole 321 is with 2mm Or 3mm is evenly spaced distributed on film, the ventilative of film both sides is realized.
When carrying out the via design of film, the gas permeability of film and film strength are accounted for as two targets, at the same time Realize the function of this two aspects.The diameter of through hole has been designed as 2mm or 3mm by the experiment of early period, from Top to bottm designs more exhausting holes, as shown in table 1 below.Come after the completion of via design with two quantitative targets of permeability rate and tensile strength Investigate the gas permeability and intensity two indices of the film of setting.
Table 1
Experiment shows that the five exhausting holes design of scheme 3 and seven exhausting holes of scheme 4 design, in permeability rate and tensile strength Two targets delivery rate is high at the same time.If hole is too many, the relative density of film, which reduces tensile strength, to be reduced, and influences film strength With practical operation feasibility in art.If hole is very little, the gas permeability of film is affected, it is impossible to realizes that the material of film both sides is handed over Change, influence therapeutic effect.
The medicine of implant 3 can be female hormone, its targeted release repairs the wound face of inflammation or endometrium.According to The demand of Different Individual, 17- β estradiol 10% Indomethacin of blending that female hormone can be designed as 90% are used in combination;Or Independent 100% 17- β estradiol is used.Medicine may be designed as having different release behaviors, as shown in table 2 below.
Table 2
Medicine Daily burst size Total drug content
100%17- β estradiol ≤20μg 5mg
100%17- β estradiol ≤50μg 5mg
100%17- β estradiol ≤100μg 5mg
100%17- β estradiol ≤200μg 5mg
+ 10% Indomethacin of 90%17- β estradiol ≤20μg 5mg
+ 10% Indomethacin of 90%17- β estradiol ≤50μg 5mg
+ 10% Indomethacin of 90%17- β estradiol ≤100μg 5mg
+ 10% Indomethacin of 90%17- β estradiol ≤200μg 5mg
The amount of the insoluble drug release can be adhered the degree of adhesion according to uterine cavity, such as slight, the journey of moderate and moderate adhesion Corresponding burst size is selected after spending different progress type selectings, specifically can slightly select the burst size of 20 μ g or 50 μ g, moderate can To select the burst size of 100 μ g, severe can select the burst size of 200 μ g.Or according to judgement of the doctor to patient and according to warp Test use.
The medicine of implant 3 can be loaded in matrix by way of spraying or dip-coating.In one embodiment, by base Matter is positioned on spraying frame and fixes, and spraying equipment is with 1 μ g/s or 5 μ g/s or suitable spraying rate point spray thing.By nozzle Film-shaped products are sprayed back and forth, specific time 50s-200s, uniformly covers medicine on film-shaped products, so that real Now orient the purpose quantitatively discharged.It should be understood that the translational speed of spraying equipment may cause very much to spray uneven soon, speed is too Slow to influence production efficiency, analysis of experiments 1 μ g/s or 5 μ g/s are a rational velocity interval.In another embodiment, Matrix is positioned on dip-coating fixed frame and is fixed, fixed frame can be moved up and down with membranaceous implantation instrument, and matrix is complete It is complete be immersed in medicine after 30s-90s backed off after random containers, wait 5S, after reenter container.The process completes leaching after being repeated 3 times Technique is applied, uniformly covers medicine in matrix, the purpose quantitatively discharged so as to fulfill orientation.It should be understood that matrix submerges Overlong time influences production efficiency, and the time too short adhesive force and dose for influencing medicine, is conjunction through analysis of experiments 30s-90s The spray time of reason;And matrix exits the non-homogeneous immersion distribution of stand-by period too short then medicine of container, stand-by period long shadow Production efficiency is rung, through analysis of experiments, 5S is a suitable time.In yet another embodiment, the medicine of implant 3 can be The inside of matrix is distributed in the forming process of matrix, so as to be supported in matrix.For example, by the way that matrix estradiol molecules are molten The mode of coating film forming is processed making after gelatin solution.The biogelatin solution of configuration 1%~5% first, configures Under 48 DEG C~52 DEG C parameters, solution will be stirred evenly with certain rotating speed in quantitative estradiol addition solution after, with After be put into pure-natural biological crosslinking agent Geniposide, continue stirring 1~5 minute, with increase form a film after physical property.Test it PH value ensures the pH value average of solution near 7.0.Gelatin solution is evenly applied to shape particular design after the completion of test In polyester base model, it can be taken off being used after film drying.The step can ensure that estradiol uniformly divides in gelatin film Cloth, to realize the release of the estradiol in art and gelatin degradation while the effect of effect.
It is above-described, it is only presently preferred embodiments of the present invention, is not limited to the scope of the present invention, of the invention is upper Stating embodiment can also make a variety of changes.What i.e. every claims and description according to the present patent application were made Simply, equivalent changes and modifications, falls within the claims of patent of the present invention.The not detailed description of the present invention is Routine techniques content.

Claims (12)

1. a kind of degradable inner membrane of uterine cavity implant system, including delivery pipe, push rod and implant, at least part push rod are contained in In delivery pipe, implant is contained in delivery pipe and receives the promotion of push rod in the first state, and implant is with the membranaceous of medicine Or laminated structure, implant include the medicine of the matrix and load of biodegradable material on the substrate, are provided with matrix Connect the through hole of membranaceous or laminated structure both sides.
2. inner membrane of uterine cavity implant system according to claim 1, it is characterised in that the delivery pipe is circular tube structure, in it Side wall is formed as step wall and limits the major diameter cavity and minor diameter cavity of connection.
3. inner membrane of uterine cavity implant system according to claim 2, it is characterised in that push rod is straight-bar structure, including first Enlarged diameter section, reduced diameter section and the second enlarged diameter section, wherein, reduced diameter section be located at the first enlarged diameter section and the second enlarged diameter section it Between, and the first enlarged diameter section is contained in major diameter cavity and coordinates.
4. inner membrane of uterine cavity implant system according to claim 1, it is characterised in that implant is ▽ types, Y types, orType.
5. inner membrane of uterine cavity implant system according to claim 1, it is characterised in that matrix is to be supported on degradable skeleton Gelatin film or independent gelatin film.
6. inner membrane of uterine cavity implant system according to claim 5, it is characterised in that degradable skeleton is V-type.
7. inner membrane of uterine cavity implant system according to claim 1, it is characterised in that through hole is uniform with the spacing of 2mm-3mm Ground is distributed.
8. inner membrane of uterine cavity implant system according to claim 1, it is characterised in that a diameter of 2mm-3mm of through hole.
9. inner membrane of uterine cavity implant system according to claim 1, it is characterised in that -7 exhausting hole of 5 row is set in matrix.
10. inner membrane of uterine cavity implant system according to claim 1, it is characterised in that Yin is blended for 17- β estradiol in medicine The U.S. pungent joint of diindyl;Or single 17- β estradiol.
11. inner membrane of uterine cavity implant system according to claim 10, it is characterised in that the daily burst size of medicine is 20- 200μg。
12. inner membrane of uterine cavity implant system according to claim 1, it is characterised in that drug distribution is in the inside of matrix.
CN201711340775.3A 2017-12-14 2017-12-14 A kind of degradable inner membrane of uterine cavity implant system Withdrawn CN107951550A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110384830A (en) * 2018-04-19 2019-10-29 易浦润(上海)生物技术有限公司 Has the isolation film and preparation method thereof for reactivating inner membrance substrate layer function in a kind of uterine cavity
CN113262332A (en) * 2018-04-19 2021-08-17 易浦润(上海)生物技术有限公司 Elastic film

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102120059A (en) * 2011-03-11 2011-07-13 东南大学 Medicinal stent-graft for preventing and treating intrauterine adhesion
CN202843666U (en) * 2012-10-26 2013-04-03 丁书贵 Intrauterine anti-adhesion diaphragm
CN203074772U (en) * 2013-02-01 2013-07-24 浙江大学医学院附属妇产科医院 Absorbable anti-adhesion diaphragm in uterine cavity of uterus
CN103784244A (en) * 2012-10-30 2014-05-14 饶永 Intrauterine implant
CN204049793U (en) * 2014-07-26 2014-12-31 徐大宝 Intrauterine adhesion control device
CN206239777U (en) * 2016-06-23 2017-06-13 刘芸 Thing is inserted in uterus and the imbedding system of thing is inserted in uterus
CN106983918A (en) * 2017-03-03 2017-07-28 北京博辉瑞进生物科技有限公司 A kind of biological adherence preventing material, preparation method and applications
CN208573803U (en) * 2017-12-14 2019-03-05 易浦润(上海)生物技术有限公司 A kind of degradable inner membrane of uterine cavity implant system

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102120059A (en) * 2011-03-11 2011-07-13 东南大学 Medicinal stent-graft for preventing and treating intrauterine adhesion
CN202843666U (en) * 2012-10-26 2013-04-03 丁书贵 Intrauterine anti-adhesion diaphragm
CN103784244A (en) * 2012-10-30 2014-05-14 饶永 Intrauterine implant
CN203074772U (en) * 2013-02-01 2013-07-24 浙江大学医学院附属妇产科医院 Absorbable anti-adhesion diaphragm in uterine cavity of uterus
CN204049793U (en) * 2014-07-26 2014-12-31 徐大宝 Intrauterine adhesion control device
CN206239777U (en) * 2016-06-23 2017-06-13 刘芸 Thing is inserted in uterus and the imbedding system of thing is inserted in uterus
CN106983918A (en) * 2017-03-03 2017-07-28 北京博辉瑞进生物科技有限公司 A kind of biological adherence preventing material, preparation method and applications
CN208573803U (en) * 2017-12-14 2019-03-05 易浦润(上海)生物技术有限公司 A kind of degradable inner membrane of uterine cavity implant system

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110384830A (en) * 2018-04-19 2019-10-29 易浦润(上海)生物技术有限公司 Has the isolation film and preparation method thereof for reactivating inner membrance substrate layer function in a kind of uterine cavity
CN113262332A (en) * 2018-04-19 2021-08-17 易浦润(上海)生物技术有限公司 Elastic film
CN110384830B (en) * 2018-04-19 2022-06-17 易浦润(上海)生物技术有限公司 Isolating membrane with function of reactivating intima-media basal layer in uterine cavity and preparation method thereof
CN113262332B (en) * 2018-04-19 2022-06-24 易浦润(上海)生物技术有限公司 Elastic film

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Application publication date: 20180424