CN104998344A - Memory alloy silicone rubber intrauterine sustained-release system - Google Patents
Memory alloy silicone rubber intrauterine sustained-release system Download PDFInfo
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- CN104998344A CN104998344A CN201510444908.6A CN201510444908A CN104998344A CN 104998344 A CN104998344 A CN 104998344A CN 201510444908 A CN201510444908 A CN 201510444908A CN 104998344 A CN104998344 A CN 104998344A
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Abstract
The invention discloses a memory alloy silicone rubber intrauterine sustained-release system. The system comprises a skeleton which is formed by winding super-elastic memory metal wires, a gap is arranged between two adjacent super-elastic memory metal wires, and the skeleton is wrapped in a silicone rubber tube wall prepared from a mixture of silicone rubber and nano-copper; the skeleton stores therein levonorgestrel particles which can penetrate the gaps and the tube wall pores of the silicone rubber tube wall. The memory alloy silicone rubber intrauterine sustained-release system is mainly used for the prevention and treatment of adenomyosis, and pelvic endometriosis, the treatment of menorrhagia, proliferative phase endometrium, and endometrium hyperplasia, the prevention of post-surgery recurrence of endometrial polyp and chocolate cyst, and the prevention of pregnancy.
Description
Technical field
The invention belongs to contraceptive and gyniatrics technical field, be specifically related to a kind of memorial alloy silica gel in utero slow-released system.
Background technology
Adenomyosis (adenomyosis) refers to that endometrial gland and interstitial are present in myometrium, and with compensatory hypertrophy and the hypertrophy of surrounding muscle layer cell, sickness rate reaches the 10%-47% of women population.Main clinical manifestation is menorrhagia, menostaxis and the dysmenorrhea of aggravating gradually, infertile etc.Its sickness rate increases year by year, has become common gynecological disease, frequently-occurring disease, and have a strong impact on patient's physical and mental health and quality of life, thus extremely industry is paid close attention to.
From the angle of pathology, Ectopic Endometrium in myometrium more is diffuse growth, involves rear wall in the majority, and Fructus Psoraleae palace is that uniformity increases, and increases obviously with anteroposterior diameter, spherical in shape.Because gland myopathy patient often exists the symptoms such as menorrhagia, dysmenorrhea be obvious (see 1. Nabeshima H, Murakami T, Nishimoto M, et al. Successful total laparoscopic cystic adenomyomectomy after unsuccessful open surgery using transtrocar ultrasonographic guiding. J Minim Invasive Gynecol, 2008,15 (2): 227 – 30.2. Parazzini F, Vercellini P, Panazza S, et al. The risk factors for adenomyosis. Hum Reprod 1997, 12: 1275–9。3. Vavilis D, Agorastos T, Tzafetas J, et al. Adenomyosis at hysterectomy:its prevalence and its relationship to the operative findings and the reproductive and the menstrual factors. Clin Exp Obstet Gynaecol, 1997,24:36-38.), patient generally can actively seek treatment.
The clinical treatment of gland myopathy receives much attention always, and clinical treatment totally can be divided into two classes, and a class is the pregnancies with conservative treatment of Reservations uterus, comprises Drug therapy, naturopathy and conservative surgeries in treating (lesion resection); Two classes are treatment and the hysterectomy of non-Reservations uterus.
The medicine for the treatment of gland myopathy is various, as mifepristone, danazol, gestrinone, GnRH-a etc., have that Different therapeutical effect is large, side effect obviously, costly and the problem such as to recur after drug withdrawal (see 4. Yang J-H, Ho H-N, Yang Y-S. Current diagnostic and treatment strategies for adenomyosis. Expert Rev. Obstet. Gynecol, 2006,1 (1): 111-120.).Naturopathy mainly contains high intensity focused ultrasound (High Intensity Focused Ultrasound, HIFU), but there is apparatus expensive, to be non-ly generally suitable for, not thoroughly, easily the problem such as recurrence is (see 5. Dong X in treatment, Yang Z. High-intensity focused ultrasound ablation of uterine localized adenomyosis.Curr Opin Obstet Gynecol, 2010,22:326-330.6. Min Zhou, Jin-Yun Chen, Liang-Dan Tang, Wen-Zhi Chen, Zhi-Biao Wang. Ultrasound-guided high-intensity focused ultrasound ablation for adenomyosis: the clinical experience of a single center. Fertility and Sterility, 2011. 95(3): 900-905.）。Conservative operation dealing mainly contains uterine artery interventional embolization (Uterine artery embolization, UAE), hysteroscope TCRE (transcervical resection of endometrium, and uterine lesion excision (resection of uterine lesion, RUL) TCRE).These pregnancies with conservative treatment modes all exist that indication scope is little, not thoroughly, easily the problem such as recurrence is (see 7. Gupta in treatment, J. K, Sinha, A., Lumsden, et al. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database of Systematic Reviews. 2006,25 (1): CD005073.8. Vashisht A, Studd JW, Carey AH. "Fibroid Embolisation: A Technique Not Without Significant Complications". British Journal of Obstetrics & Gynecology.2000,107(9): 1166–1170。9 . Wang CJ, Yen CF, Lee CL, et al. Laparoscopic uterine artery ligation for treatment of symptomatic adenomyosis. J Am Assoc Gynecol Laparosc 2002, 9(3): 293-296。10. Xia Enlan, Duan Hua, Liu Yuhuan, Deng. the clinical practice of Transcervical Resection of Endometrium and late result analysis, China's journal of obstetrics and gynecology, 2004,39 (5): 296-300), thus make most of Patients with Adenomyosis, be that serious symptom and expectant treatment loser are finally forced to hysterectomize especially.
Uterus is the symbol of women and the important organ pipe of quality of life, and hysterectomy can cause many adverse effects to the physiology of women, psychology.Patients with Adenomyosis mostly is women at fertile age, in order to effective disease therapy, prevention of recurrence also retains patient uterine, applicant is through studying for a long period of time, propose according to Uterine lesion degree calibration, and select " Man Yuele (Mirena) three scheme " of therapeutic scheme to treat adenomyosis by calibration, and in wound " Shore Achates art (MUFU) " treatment, severe patient and additive method loser, achieve significant therapeutic effect (see 10. Xiao Yan ice, Zhao Jing, Li Qinghan, Deng. " flesh wall large portion excision-uterus Reconstruction " treatment in, severe adenomyosis---art formula and Research on safety. Zunyi Medical College's journal, 2012, 35 (4): 302-305.11. Zhao Jing, Li Qinghan, Fang Derong, etc. flesh wall large portion excision-uterus Reconstruction is combined in the happy treatment of the graceful moon, the curative effect [J] of severe adenomyosis. Chinese Human-Female children health care, 2013,15:2464-2466.12. side's morals are held, Zhao Jing, Li Qinghan, etc. the preliminary study [J] of happy treatment of graceful moon adenomyosis focus threshold value screening. Zunyi Medical College's journal, 2014,37 (4): 418-421).At present, applicant team has begun to take shape a whole set of system about the thought of adenomyosis calibration treatment, method, standard, scheme, operation and apparatus/drug research and development." happy three schemes of the graceful moon " and " Shore Achates art " based on calibration thought can avoid patient to hysterectomize because of gland myopathy from methodology.
The graceful moon, pleasure was a kind of New-type long-acting contraceptive device, was in recent years progressively applied to the correlational study in non-contraception field.Being happy to nineteen ninety the graceful moon goes on the market at European registration, and in 2000 in Discussion on Chinese Listed, in the same year, is gone on the market in the U.S. by FDA approval.The graceful moon, happy contained effective constituent was LNG (LNG, 52mg/ prop up), and LNG is the potent progestogen of synthetic, is the optically active body of racemization norgestrel, and activity is about 100 times of norethindrone.Levonorgestrel mainly acts on hypothalamus and hypophysis, and make the peak of midcycle FSH and LH level obviously reduce or disappear, ovary is not ovulated, and has obvious antiestrogenic, and cervical mucus retrogradation can be made to hinder Sperm penetration.Extremely strong progestin is shown to endometrial transformation, endometrium can be made thinning, and intimal epithelium cell is low cylindricality, and secretory function is bad, be unfavorable for implantation of ovum, thus have fabulous contraceptive effect (see: 13.http: //baike.baidu.com/view/569093.htm).
After the graceful moon, pleasure inserted cavity of uterus, the LNG left in vertical tube can quantitatively discharge (20 μm/d).Research shows, have the effect of prevention gynecopathy progress and recurrence after Man Yuele in utero places, and has certain therapeutical effect (see 14. Bednarek, P. H. to part gland myopathy (focus smaller), Jensen, J. T. Safety, efficacy and patient acceptability of the contraceptive and non-contraceptive uses of the LNG-IUS. International journal of women's health, 2010, 9 (1): 45 – 58.), its mechanism may be a kind of efficient progestogen at LNG contained in the inner, this hormone can keep high concentration and continuous action by film in uterus, fundamentally can change endometrial pathological state (see 15. Wan YL, Holland C. The efficacy of levonorgestrel intrauterine systems for endometrial protection:a systematic review. Climacteric. 2011, 14 (6): 622-32.), even if be there is dystopy by improved inner membrance in these, also can not cause the generation of gynecopathy (see: 16. bright scapes and. the Railway Project of the basic and clinic studies of endometriosis. Chinese practical gynecological and obstetrics' magazine, 2002, 18 (3): 129-130.16. bright scapes and. the basic and clinic studies [M] of endometriosis. Beijing: publishing house of China Concord Medical Science University, 2003,244-245.).These pharmacological properties of LNG, make Man Yuele have contraception concurrently, the effect of the diseases such as treatment gland myopathy, irregular menstruation.
But, find in the process of clinical practice, the following problems of happy existence of the graceful moon:
(1) the graceful moon, happy shape was "T"-shaped, therefore ring easily moves down, even obscission is obvious, and because its active ingredient (LNG) is stored in longitudinal tubule (L tubule), therefore, once ring moves down, its therapeutic effect will be affected or not have effect;
(2) support that the graceful moon is happy is organic plastics, when the LNG release in longitudinal tubule (L tubule) is complete or after a large amount of decay, because plastics are inert material, its contraceptive effect is by bright decline;
(3) the LNG dosage stored in longitudinal tubule (L tubule) is less than normal (52mg), is used for the treatment of object effect not ideal;
(4) expensive (1200 yuan ~ 1400 yuan /), once ring moves down, comes off or poor effect, can bring larger financial burden to patient.
Summary of the invention
In view of this, the object of the present invention is to provide a kind of memorial alloy silica gel in utero slow-released system, it has prevention, treatment adenomyosis and some other gynaecopathia, has the effect of contraceptive effect simultaneously.
For achieving the above object, the invention provides following technical scheme:
A kind of memorial alloy silica gel in utero slow-released system, comprise skeleton, described skeleton adopts super elastic memory metal silk to be entwined, and is provided with gap between adjacent two described super elastic memory metal silks, and on described skeleton, parcel is provided with the silica gel tube wall adopting the mixture of silica gel and Nanometer Copper to make; The LNG microgranule that can pass the tube wall aperture of described gap and described silica gel tube wall is stored in described skeleton.
Further, described skeleton adopts titanium-nickel memory alloy wires to be entwined.
Further, rounded, the palace shape of described skeleton or be inverted Ω shape.
Beneficial effect of the present invention is:
Memorial alloy silica gel of the present invention in utero slow-released system, according to physicochemical property, the pharmacological property of LNG, the nanotechnology feature of silica gel, in conjunction with modern intrauterine device (IUD) production technology, provide one and there is prevention, treatment adenomyosis and some other gynaecopathia, there is the IUD of contraceptive effect simultaneously; Memorial alloy silica gel of the present invention in utero slow-released system has following advantage:
1. adopt super elastic memory metal silk to be wound around and make skeleton, make IUD deformable, the placement of favourable IUD and taking-up;
2. skeleton is all silica gel tube wall parcel, can avoid the generation of bare mental stents IUD incarceration phenomenon;
The copper 3. with contraceptive efficacy exists with nano-form, naked copper IUD can be avoided to there is the burst release phenomenon (releasing product based on the oxide of copper, the oxidation product of the excessive release of this copper ion and a large amount of copper of generation may cause putting metrorrhagia, pain etc. after device) of copper ion at the placement initial stage;
4. being stored in LNG in skeleton can with microgranule individualism, or mixes with other materials and store, can by controlling the size in silica gel tube cinclides footpath, realize the quantitative release (slow release or control slow) of LNG;
5. the profile of memorial alloy silica gel of the present invention in utero slow-released system is not " circular, palace shape or be inverted Ω shape ", primarily of skeleton and silica gel composition, can keep intrinsic shape and some tension in uterine cavity, yielding and come off;
6. can adjust LNG dosage in silica gel tube easily, by this system respectively or combine for contraception or therapeutic purposes.
Memorial alloy silica gel of the present invention in utero slow-released system can be used for:
1. Prevention and Curation adenomyosis, endometriosis of pelvis;
2. menorrhagia, proliferative phase of endometrium, endometrial hyperplasia is treated;
3. endometrial polyp and chocolate cyst postoperative recurrence is prevented;
4. female contraception.
Accompanying drawing explanation
In order to make object of the present invention, technical scheme and beneficial effect clearly, the invention provides following accompanying drawing and being described:
Fig. 1 is the cross section structure schematic diagram of memorial alloy silica gel of the present invention in utero slow-released system;
Fig. 2 is the structural representation of rounded super elastic memory metal silk skeleton;
Fig. 3 is the structural representation of the super elastic memory metal silk skeleton in palace shape;
Fig. 4 is the structural representation in the super elastic memory metal silk skeleton being inverted Ω shape.
Detailed description of the invention
Below in conjunction with the drawings and specific embodiments, the invention will be further described, can better understand the present invention and can be implemented, but illustrated embodiment is not as a limitation of the invention to make those skilled in the art.
As shown in Figure 1, be the cross section structure schematic diagram of memorial alloy silica gel of the present invention in utero slow-released system.The memorial alloy silica gel in utero slow-released system of the present embodiment, comprise skeleton 1, described skeleton 1 adopts super elastic memory metal silk 2 to be entwined, be provided with gap 3 between adjacent two described super elastic memory metal silks 2, on described skeleton 1, parcel is provided with the silica gel tube wall 4 adopting the mixture of silica gel and Nanometer Copper to make.The LNG microgranule 5 that can pass the tube wall aperture of described gap 3 and described silica gel tube wall 4 is stored in described skeleton 1.
Further, described skeleton 1 adopts titanium-nickel memory alloy wires to be entwined, and skeleton 1 can be set to rounded, palace shape or be inverted Ω shape, and respectively as shown in figs 2-4, the super elastic memory metal silk skeleton 1 of the present embodiment is set to palace shape.
The memorial alloy silica gel in utero slow-released system of the present embodiment, according to physicochemical property, the pharmacological property of LNG, the nanotechnology feature of silica gel, in conjunction with modern intrauterine device (IUD) production technology, provide one and there is prevention, treatment adenomyosis and some other gynaecopathia, there is the IUD of contraceptive effect simultaneously; Memorial alloy silica gel of the present invention in utero slow-released system has following advantage:
1. adopt super elastic memory metal silk to be wound around and make skeleton, make IUD deformable, the placement of favourable IUD and taking-up;
2. skeleton is all silica gel tube wall parcel, can avoid the generation of bare mental stents IUD incarceration phenomenon;
The copper 3. with contraceptive efficacy exists with nano-form, naked copper IUD can be avoided to there is the burst release phenomenon (releasing product based on the oxide of copper, the oxidation product of the excessive release of this copper ion and a large amount of copper of generation may cause putting metrorrhagia, pain etc. after device) of copper ion at the placement initial stage;
4. being stored in LNG in skeleton can with microgranule individualism, or mixes with other materials and store, can by controlling the size in silica gel tube cinclides footpath, realize the quantitative release (slow release or control slow) of LNG;
5. the profile of memorial alloy silica gel of the present invention in utero slow-released system is not " circular, palace shape or be inverted Ω shape ", primarily of skeleton and silica gel composition, can keep intrinsic shape and some tension in uterine cavity, yielding and come off;
6. can adjust LNG dosage in silica gel tube easily, by this system respectively or combine for contraception or therapeutic purposes.
The memorial alloy silica gel of the present embodiment in utero slow-released system can be used for:
1. Prevention and Curation adenomyosis, endometriosis of pelvis;
2. menorrhagia, proliferative phase of endometrium, endometrial hyperplasia is treated;
3. endometrial polyp and chocolate cyst postoperative recurrence is prevented;
4. female contraception.
The above embodiment is only that protection scope of the present invention is not limited thereto in order to absolutely prove the preferred embodiment that the present invention lifts.The equivalent alternative or conversion that those skilled in the art do on basis of the present invention, all within protection scope of the present invention.Protection scope of the present invention is as the criterion with claims.
Claims (3)
1. a memorial alloy silica gel in utero slow-released system, it is characterized in that: comprise skeleton, described skeleton adopts super elastic memory metal silk to be entwined, be provided with gap between adjacent two described super elastic memory metal silks, on described skeleton, parcel is provided with the silica gel tube wall adopting the mixture of silica gel and Nanometer Copper to make; The LNG microgranule that can pass the tube wall aperture of described gap and described silica gel tube wall is stored in described skeleton.
2. memorial alloy silica gel according to claim 1 in utero slow-released system, is characterized in that: described skeleton adopts titanium-nickel memory alloy wires to be entwined.
3. memorial alloy silica gel according to claim 1 in utero slow-released system, is characterized in that: described skeleton is rounded, palace shape or be inverted Ω shape.
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| CN201510444908.6A CN104998344A (en) | 2015-07-27 | 2015-07-27 | Memory alloy silicone rubber intrauterine sustained-release system |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110418658A (en) * | 2017-02-01 | 2019-11-05 | 塔里斯生物医药公司 | The method of vivo drug delivery device and drug delivery |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2090248U (en) * | 1991-02-01 | 1991-12-11 | 重庆市南桐矿区人民医院 | Uterus-form intrauterine contraceptive device with function of releasing cupric ions slowly |
| CN1903148A (en) * | 2006-08-09 | 2007-01-31 | 华中科技大学 | Active endouterine contraceptive device made of composite material |
| CN202821784U (en) * | 2012-09-20 | 2013-03-27 | 冯秀芝 | Anti-dropping intrauterine contraceptive device with adjuvant therapy function |
| CN204745334U (en) * | 2015-07-27 | 2015-11-11 | 肖雁冰 | Memory alloy silica gel is slow release system in utero |
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2015
- 2015-07-27 CN CN201510444908.6A patent/CN104998344A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2090248U (en) * | 1991-02-01 | 1991-12-11 | 重庆市南桐矿区人民医院 | Uterus-form intrauterine contraceptive device with function of releasing cupric ions slowly |
| CN1903148A (en) * | 2006-08-09 | 2007-01-31 | 华中科技大学 | Active endouterine contraceptive device made of composite material |
| CN202821784U (en) * | 2012-09-20 | 2013-03-27 | 冯秀芝 | Anti-dropping intrauterine contraceptive device with adjuvant therapy function |
| CN204745334U (en) * | 2015-07-27 | 2015-11-11 | 肖雁冰 | Memory alloy silica gel is slow release system in utero |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110418658A (en) * | 2017-02-01 | 2019-11-05 | 塔里斯生物医药公司 | The method of vivo drug delivery device and drug delivery |
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Application publication date: 20151028 |