A kind of intrauterine implantTechnical field
The present invention relates to gynecological's medical instruments field, particularly, the present invention relates to a kind of intrauterine implant.
Background technology
Intrauterine device (Intrauterine device, IUD) early than 1909 for contraception, be a kind of contraceptive effect good, safe, easy to use, economical, act on reversible long-acting contraception method.World Health Organization (WHO) statistics in 2002 show that existing 1.56 hundred million women in the whole world use IUD, and wherein Asian countries's user occupies the majority, and it is global 2/3 that Chinese user almost accounts for, and long-term use certificate understands that its safety can trust.
The present invention, on the product and shape basis of intrauterine device, removes the medicine and the copper product that play birth control effect, continues to use its safe mounting system, increases with the membrane structure of estrogen and progestogen medicine, to treat and to prevent in uterine cavity and the adhesion of cervix uteri.
Intrauterine adhesion claims again Asherman syndrome, refers to that uterine cavity flesh wall and/or neck tube are adhered mutually due to after uterine cavity due to various factors or neck tube basal layer inner film injury.Metrosynizesis is common gynecological disease, and basal layer endometrium sustains damage, and can produce fibrous connective tissue and be connected between uterine cavity inwall, even causes the disappearance of uterine cavity normal configuration, intrauterine adhesion sealing to no longer include lacuna when serious.Metrosynizesis is relevant with uterine neck diseases, repeatedly artificial abortion (particularly induced abortion), postoperative short-term sexual life and the operation lack of standardization of performing the operation with uterus.
Hysteroscope is the goldstandard of current intrauterine adhesion diagnosis and the prefered method for the treatment of, but follow-uply prevents that again in adhesion treatment, still there is no effectively in uterine cavity, to play barrier action carries out adhesion obstruct and promote the effective ways that inner membrance is grown.Meanwhile, for the prevention of the postoperative adhesion again of conventional intrauterine surgical, there is no good way yet.Conventional Therapeutic Method has several as follows at present:
1. intrauterine device
Current most scholar is using the classical way that after intrauterine adhesion exclusion, uterine cavity placement of intrauterine devices is adhered as prevention of postoperative for 2~3 months again.But not good enough for being adhered again effect after prevention severe intrauterine adhesion operation in patients, can not effectively intercept uterus front and rear wall; And may cause excessive inflammatory reaction, and cause a large amount of inflammatory mediators and urge being adhered formation release of cytokines, accelerate the postoperative formation being adhered again.
2. balloon expandable method
Commonly use clinically at present Foley sacculus urinary catheter as utricule.But there is retrograde infection, service time is shorter, use is inconvenient, sacculus water-filling pressure is difficult for the problems such as Accurate Measurement.
3. biogum class
At present clinical is mainly the hyaluronic derivant-self-crosslinking of latest generation polysaccharide gel (auto-cross-linked polysaccharides gel, ACPgel) for preventing the postoperative biogum that is adhered again formation of intrauterine adhesion.Can rest on for a long time the wound surface surface being adhered after separation, avoid wound surface to be affixed, inflammation-inhibiting cell migration, restriction Fibrinogen diffusion, thus play prevention of postoperative and be adhered again the effect of formation.Though ACPgel degradation time has clear improvement compared with HA, but the longest is 72 hours, though the effect that has prevention to be adhered again at the commitment of wound healing, but the wound healing later stage is adhered in the slow process of formation again, the effect of ACPgel is obviously not as good as intrauterine device and Foley sacculus urinary catheter, therefore expect that retention time is longer, more the biogum class of degradation resistant occurs.
4. estrogen
After intrauterine adhesion exclusion routine give oral or injection estrogen and progestogen sequentialartificial cycle 2~3 months or apply separately estrogenic measure prevention light-certainly, menstruation recovery and reproduction prognosis all obviously improve to be adhered in formation effect after moderate intrauterine adhesion patient is adhered exclusion again.But severe intrauterine adhesion patient effect is pessimistic, the postoperative rate that is adhered again can reach more than 50%.Suggest severe intrauterine adhesion patient inner membrance basal layer destroys serious, in the situation of estrogen deficiency reaction, emphasizes simply whether high estrogen level can cause some short factor level that is adhered to rise, and increases the weight of to be adhered and the generation of intimal fibrosis again.In addition, can the estrogen through liver metabolism cannot be determined the bioavailability of remaining inner membrance effective stimulus, and oral administration can produce stimulation to whole body target organ, can aggravate the stimulation of endometriosis focus and breast tumor cell, be unfavorable for the fertility expection that patient is final.Therefore the effect that, estrogen is adhered in formation after severe intrauterine adhesion patient is adhered exclusion again needs further to be inquired into.Separately, a large-scale Denmark comparative study shows, uses the women of the oral contraceptive that contains a small amount of or minute quantity estradiol, and the relative risk that thrombotic apoplexy and myocardial infarction (MI) occur is 1 ~ 2 times of user not.
5. Fiber-hysteroscope is detected and blunt separation art
Intrauterine adhesion patient from postoperative 2 weeks, every within 1~3 week, carry out primary fiber hysteroscope detect with mirror under the newborn loose band blunt separation art that is adhered, what be adhered with prevention of postoperative densification forms again.Not there is not problems such as " intrauterine device bring out chronic inflammatory disease, and Foley sacculus urinary catheter causes infecting and incompetence,cervical " in the method, but still does not solve the problem of prevention and daily obstruct adhesion, and patient compliance is poor.
There are two main problems in above-mentioned these methods: 1, the impact of systemic administration.2, additive method is in operational low effect, inconvenience and risk.Can be found out by above analysis, keep the screen effect of uterine cavity implant and pass through to increase medicine local sustained release to eliminate hormone medicine systemic administration disadvantage, and by controlling the indwelling time of implant and discharging medicament categories, realization has stage chemotherapy journey arrangement, can realize the good result of the treatment of uterine cavity implant and prevention metrosynizesis.
Using this kind of uterine cavity implant product as medical apparatus and instruments, the application for the treatment of and prevention metrosynizesis does not also have report.
Summary of the invention
The object of the invention is to, a kind of uterine cavity implant that contains estrogen and/or progestogen, can intercept endometrium contact is provided, overcome on the one hand the side effect causing thus in whole body administration; On the other hand, strengthened barrier action and interim targetedly, the result of use of targeting medication.
For achieving the above object, intrauterine implant of the present invention, comprisessupport 1 and is coated on thepastille diaphragm 3 onsupport 1.
According to intrauterine implant of the present invention, describedpastille diaphragm 3 is coated onsupport 1 and forms membrane layer.Further, describedpastille diaphragm 3 can also divide some sections to be coated on and onsupport 1, to form membrane layer spaced apart.
According to intrauterine implant of the present invention, preferably, on the three-dimensional region of outline that describedpastille diaphragm 3 integral coating form insupport 1, form membrane body.
According to intrauterine implant of the present invention, further, describedsupport 1 can be T shape, and the coated delta-shaped region forming with 1 liang of arm end points of support and vertical shaft bottom end points that is filled in ofpastille diaphragm 3 forms membrane body.
Or describedsupport 1 can be γ shape, the coated delta-shaped region forming with 1 liang of arm end points of support and bottom end points that is filled in ofpastille diaphragm 3 forms membrane body.
Describedsupport 1 shape can also be the distortion of above-mentioned T shape or γ shape, for example, each shape shown in the T-shaped or Fig. 6 of ring-type shown in Fig. 1, includes but not limited to γ shape, the fork-shaped etc. of the straight and sealing of V font, both arms that ring-type Y-shaped, Y-shaped, both arms are ring-type.
When above-mentionedsupport 1 is T shape, when γ shape or both distortion, described delta-shaped region forms membrane body, is not limited to regular triangle, also comprises the shape of irregular entirety structure triangular in shape, as triangle both sides are concavo-convex staggered structure.Particularly, for example both sides can be dentation, and described profile of tooth can be preferably trapezoidal or circular arc (as shown in figure 10).
Above-mentionedsupport 1 can also be annular, andpastille diaphragm 3 is coated and is filled in whole annular region.
Describedsupport 1 is when annular, as shown in Figure 5, can also but be not limited to petal or butterfly that the Pear-Shaped of biarc connecting composition, four circular arcs form, fan-shaped etc., can also as required, difform supporter be set in annulus.Can also be as required, bypastille diaphragm 3 hollow outs (as shown in figure 11) in annulus.
According to intrauterine implant of the present invention, describedpastille diaphragm 3 contained drugs are estrogen, progestogen or both mixture, and preferably, the outer medicine ofpastille diaphragm 3 is estrogen, and interior nuclear pharmaceuticals is estrogen, both mixture of progestogen.
According to intrauterine implant of the present invention, the nearly cervix uteri end of described intrauterine implant is provided with pastillecaudal vertebra 4, and described pastillecaudal vertebra 4 contained drugs are estrogen, progestogen or both mixture.
According to intrauterine implant of the present invention, while forming membrane body on the three-dimensional region of outline forming insupport 1 in above-mentionedpastille diaphragm 3 integral coating, can also onsupport 1, be provided with somepastille inclusion enclaves 2, describedpastille inclusion enclave 2 thickness are higher than pastille diaphragm 3.Thesepastille inclusion enclave 2 contained drugs are estrogen, progestogen or both mixture, and the outer medicine of describedpastille diaphragm 3 is estrogen, and interior nuclear pharmaceuticals is estrogen, both mixture of progestogen.
According to intrauterine implant of the present invention, the nearly cervix uteri end of described intrauterine implant can also be provided with pastillecaudal vertebra 4, and described pastillecaudal vertebra 4 contained drugs are estrogen, progestogen or both mixture.Described pastillecaudal vertebra 4, rests in cervix uteri, plays the effect that prevents cervical adhesion, and increases the convenience of placing and taking out intrauterine implant.
According to intrauterine implant of the present invention, the nearly cervix uteri end of above-mentioned all types of implants can also be provided withtailfiber 5, the implant of conveniently taking, and describedtailfiber 5 is medical polyester nylon wire.
According to intrauterine implant of the present invention, described support is medical corrosion-resistant metal materials support.Described pastille diaphragm, the material of pastille inclusion enclave and pastille caudal vertebra can be that medical anti-adhesive material is (such as silicone rubber, politef, ethyl cellulose nylon, medical natural polymer is (as osseocolla, gelatin, sodium alginate, agar, medical chitose (Medical Chitosan chitosan), hyaluronic acid and derivant thereof etc.), medical semisynthetic macromolecule (as cellulose derivative etc.), medical synthetic macromolecule is (as polydextrose acid, polylactic acid, polyglycolic acid, polyester, polydimethylsiloxane (PDMS) material) etc., wherein, being preferably silastic material makes.The diaphragm of making can folding and unfolding launches, and above-mentioned each parts contained drug is estrogen and/or progestogen, in uterine cavity slow release topical, prevent the general action of hormone medicine, the barrier action of performance medical grade silicon rubber material.
The present invention relates to a kind of uterine cavity implant containing estrogen and/or progestogen, improved significantly the stimulus effects implanting long-term uterine cavity implant uterus is caused, to Uterine mucosa repair effect the problem such as lower and drug-induced systemic effects of oral hormone class, and greatly improved effect and the personalized degree while use stage by stage.
Intrauterine implant of the present invention, describedpastille diaphragm 3 can also be replaced bypastille diaphragm 7 not, i.e. and intrauterine implant of the present invention comprisessupport 1 and is coated on the notpastille diaphragm 7 onsupport 1.
According to intrauterine implant of the present invention, preferably, on the three-dimensional region of outline that described notpastille diaphragm 7 integral coating form insupport 1, form membrane body.
According to intrauterine implant of the present invention, further, describedsupport 1 can be T shape, and the coated delta-shaped region forming with 1 liang of arm end points of support and vertical shaft bottom end points that is filled in ofpastille diaphragm 7 does not form membrane body.
Or describedsupport 1 can be γ shape, the coated delta-shaped region forming with 1 liang of arm end points of support and bottom end points that is filled in ofpastille diaphragm 7 does not form membrane body.
Describedsupport 1 shape can also be the distortion of above-mentioned T shape or γ shape, for example, each shape shown in the T-shaped or Fig. 6 of ring-type as shown in Figure 1, includes but not limited to γ shape, the fork-shaped etc. of the straight and sealing of V font, both arms that ring-type Y-shaped, Y-shaped, both arms are ring-type.Wherein, thepastille inclusion enclave 2 of above-mentioned each figure,pastille diaphragm 3 and pastillecaudal vertebra 4 bypastille inclusion enclave 6 not, notpastille diaphragm 7 and not pastillecaudal vertebra 8 replace.
When above-mentionedsupport 1 is T shape, when γ shape or both distortion, described delta-shaped region forms membrane body, is not limited to regular triangle, also comprises the shape of irregular entirety structure triangular in shape, as triangle both sides are concavo-convex staggered structure.Particularly, for example both sides can be dentation, and described profile of tooth can be preferably trapezoidal or circular arc (as shown in figure 10, each pastille part all not pastille).
Above-mentionedsupport 1 can also be annular, andpastille diaphragm 7 is not coated and is filled in whole annular region.
Describedsupport 1 is when annular, as shown in Figure 5, can also but be not limited to petal or butterfly that the Pear-Shaped of biarc connecting composition, four circular arcs form, fan-shaped etc., can also as required, difform supporter be set in annulus.Can also be as required, by notpastille diaphragm 7 hollow outs in annulus (as shown in figure 11, pastille part all not pastille).
According to intrauterine implant of the present invention, while forming membrane body on the three-dimensional region of outline forming insupport 1 in above-mentioned notpastille diaphragm 7 integral coating, can also onsupport 1, be provided with some notpastille inclusion enclaves 6, described notpastille inclusion enclave 6 thickness are higher thanpastille diaphragm 7 not.
According to intrauterine implant of the present invention, the nearly cervix uteri end of described intrauterine implant can also be provided with not pastillecaudal vertebra 8, rests in cervix uteri, plays the effect that prevents cervical adhesion, and increases the convenience of placing and taking out intrauterine implant.Tailfiber 5 can also be set conveniently takes simultaneously.
Above-mentioned notpastille inclusion enclave 6 of the present invention, notpastille diaphragm 7 and the material of pastillecaudal vertebra 8 not, identical with pastillecaudal vertebra 4 withpastille inclusion enclave 2,pastille diaphragm 3, be only not contain any medicine.
The difference of not pastille intrauterine implant of the present invention and pastille intrauterine implant is,pastille inclusion enclave 2 is replaced bypastille inclusion enclave 6 not, andpastille diaphragm 3 is replaced bypastille diaphragm 7 not, and pastillecaudal vertebra 4 is replaced by pastillecaudal vertebra 8 not.
Do not contain the uterine cavity implant of medicine, except the physical barriers effect that has pastille uterine cavity implant to play, advantage easy to use, owing to not containing medicine, can on existing doctors experience medication basis, carry out external drug treatment by the person's of being combined with practical situation, and dosage and operational phase are carried out to personalization adjustment; Still can reach the repairing accelerant effect to Uterine mucosa adhesion.
To sum up, the invention has the advantages that: 1, have physical barriers effect, be convenient to treat in uterine cavity, the adhesion of cervix uteri; 2, due to containing estrogen and/or progestogen, there is the impact of accelerating rehabilitation for endometrium; Reduce the side reaction of systemic administration; 3, can be flexibly according to the occupation mode of the state of an illness and progress adjustment medicine containing the uterine cavity implant of medicine; 4,, owing to including medicine components difference, can be prepared as respectively the several types that only contains estrogen, contains estrogen and progestogen mixture, only contains progestogen; Can be in the cycle of every 30 days, the situation of repairing according to endometrium, selects different use orders, collocation order, can accomplish personalized treatment; 5, for conventional intrauterine operation, more convenient as preventative placement, the generation that can lower greatly metrosynizesis situation.
Accompanying drawing explanation
Fig. 1 intrauterine implant structure of the present invention schematic diagram (T annular).
Fig. 2 intrauterine implant structure of the present invention schematic diagram (T shape).
Fig. 3 intrauterine implant structure of the present invention schematic diagram (γ shape).
Fig. 4 intrauterine implant structure of the present invention schematic diagram (annular).
The schematic diagram of Fig. 5 intrauterine implant of the present invention annular related variation.
The schematic diagram of Fig. 6 intrauterine implant of the present invention T shape or γ shape related variation.
Fig. 7 intrauterine implant of the present invention is placed taking-up instrument.
Fig. 8 intrauterine implant structure of the present invention schematic diagram (T shape membrane body form)
Fig. 9 intrauterine implant structure of the present invention schematic diagram (T shape segmentation membrane body form)
Figure 10 intrauterine implant structure of the present invention schematic diagram (T shape dentation membrane body form)
Figure 11 intrauterine implant structure of the present invention schematic diagram (annular hollow out membrane body form)
Figure 12 intrauterine implant structure of the present invention schematic diagram (not pastille)
Accompanying drawing mark
1,support 2,pastille inclusion enclave 3, pastille diaphragm
4, pastillecaudal vertebra 5,tailfiber 6, pastille inclusion enclave not
7, notpastille diaphragm 8, pastille caudal vertebra not
The specific embodiment
In order to understand better technical scheme of the present invention, below in conjunction with accompanying drawing, implementation step of the present invention is further described.
Intrauterine implant of the present invention, comprisessupport 1 and is coated on thepastille diaphragm 3 onsupport 1.
According to intrauterine implant of the present invention, as shown in Figure 8, describedpastille diaphragm 3 is coated onsupport 1 and forms membrane layer.Further, as shown in Figure 9, describedpastille diaphragm 3 can also divide some sections to be coated on and onsupport 1, to form membrane layer spaced apart.
According to intrauterine implant of the present invention, preferably, on the three-dimensional region of outline that describedpastille diaphragm 3 integral coating form insupport 1, form membrane body.
As illustrated in fig. 1 and 2, intrauterine implant of the present invention, describedsupport 1 can be T shape, or according to the ring-type T shape of T deformation, the coated delta-shaped region forming with 1 liang of arm end points of support and vertical shaft bottom end points that is filled in ofpastille diaphragm 3 forms membrane body.
As shown in Figure 3, intrauterine implant of the present invention, describedsupport 3 can be γ shape, is provided withpastille inclusion enclave 2 at support two arms and ring bodies both sides,pastille diaphragm 3 parcels are filled in the Delta Region forming with support two arm end points and ring bodies lower extreme point.Described support shape can also be the distortion of above-mentioned T shape, T annular or γ shape, as shown in Figure 6, includes but not limited to γ shape, the fork-shaped etc. of the straight and sealing of V font, both arms that Y word annular, Y-shaped, both arms are ring-type.The implant bottom of above-mentioned each shape is provided with pastille caudal vertebra 4.Described pastillecaudal vertebra 4 preferred materials are silica gel, rest in cervix uteri, play the effect that prevents cervical adhesion, and increase the convenience of placing and taking out intrauterine implant.
As shown in Figure 4, according to intrauterine implant of the present invention, it can also be annular,pastille diaphragm 3 is coated and is filled in whole annular region, as shown in Figure 5, described ring support, can also but be not limited to the petal or butterfly, fan-shaped etc. of the Pear-Shaped of biarc connecting composition, four circular arc compositions, can also as required, difform supporter be set in annulus.
The nearly cervix uteri end of above-mentioned each intrauterine implant also can be provided with pastille caudal vertebra 4.Described pastillecaudal vertebra 4 contained drugs are estrogen, progestogen or both mixture.
Above-mentionedpastille diaphragm 3 contained drugs are estrogen, progestogen or both mixture.Particularly preferably, preparing inpastille diaphragm 3 processes, designing peripheral medicine is estrogen, and interior nuclear pharmaceuticals is estrogen, both mixture of progestogen.
While forming membrane body on the three-dimensional region of outline forming insupport 1 in above-mentionedpastille diaphragm 3 integral coating, can also onsupport 1, be provided with somepastille inclusion enclaves 2, thesepastille inclusion enclave 2 contained drugs are estrogen, progestogen or both mixture, and the outer medicine of describedpastille diaphragm 3 is estrogen, interior nuclear pharmaceuticals is estrogen, both mixture of progestogen.
Intrauterine implant of the present invention is provided withtailfiber 5 at nearly cervix uteri end, can conveniently take, and describedtailfiber 5 is medical polyester nylon wire.
Intrauterine implant of the present invention, specifically apply and operate as follows:
According to intrauterine implant of the present invention, in the time making pastille inclusion enclave, pastille diaphragm or pastille caudal vertebra, can be as required, after described estrogen, progestogen or the two mixture are mixed homogeneously with raw material (medical anti-adhesive material), molding, fill with mould, make corresponding pastille inclusion enclave, pastille diaphragm or pastille caudal vertebra.
The medication amount of putting into is added as basis take general knowledge known in this field, and preferably, each medicine requires the concentration discharging to see thefollowing form 1 every day.
Table 1 medicine burst size every day
Medicine | Require burst size every day |
Estradiol | 30 mg/day and following |
Natural progesterone | 40 micro-grams/day and following |
Levonorgestrel | 20 micro-grams/day and following |
1, according to metrosynizesis and loosen postoperative situation, select the intrauterine implant that only containing estrogen, only contains progestogen or contain estrogen and progestogen mixture, generally only contain estrogenic type in just postoperative selection, use 30 days, then check, optionally have or not improvement and doctor's judgement, then select an intrauterine implant that only contains estrogen or only contain progestogen or contain estrogen and progestogen mixture.
2, according to doctor's judgement, select suitable uterine cavity implant take 30 days as one treatment cycle, can end in advance and change the intrauterine implant of variety classes (different pharmaceutical).
3,, according to doctor's judgement, can select one or more treatment cycle, to reach treatment and preventive effect.
4, laying method as IUD laying method, but will be bytailfiber 5 from intracavity extends to cervix uteri mouth.Place taking-up instrument as shown in Figure 7.
Intrauterine implant of the present invention, describedpastille inclusion enclave 2,pastille diaphragm 3 and pastillecaudal vertebra 4 can be respectively bypastille inclusion enclave 6 not,pastille diaphragm 7 is not replaced with pastillecaudal vertebra 8 not, makes intrauterine implant entirety of the present invention containing medicine.Wherein an example as shown in figure 12.
The concrete application of intrauterine implant and the operation of not pastille of the present invention are as follows:
According to intrauterine implant of the present invention, in the time making, directly use raw material (medical anti-adhesive material), molding, filling mould, makes accordingly not pastille inclusion enclave, not pastille diaphragm or pastille caudal vertebra not.
1, according to metrosynizesis and loosen postoperative situation, select this intrauterine implant, use 30 days, then check, optionally has or not improvement and doctor's judgement, then selects new this intrauterine implant.At therapeutic process simultaneously, doctor should assist with external drug (oral or external) to reach therapeutic effect, and the medication amount that use is take general knowledge known in this field as basis.
2, according to doctor's judgement, select suitable uterine cavity implant take 30 days as one treatment cycle, can end in advance and change the intrauterine implant of variety classes (different pharmaceutical).
3,, according to doctor's judgement, can select one or more treatment cycle, to reach treatment and preventive effect.
4, laying method as IUD laying method, but will be bytailfiber 5 from intracavity extends to cervix uteri mouth.Place taking-up instrument as shown in Figure 7.
It should be noted last that, above embodiment is only unrestricted in order to technical scheme of the present invention to be described.Although the present invention is had been described in detail with reference to embodiment, those of ordinary skill in the art is to be understood that, technical scheme of the present invention is modified or is equal to replacement, do not depart from the spirit and scope of technical solution of the present invention, it all should be encompassed in the middle of claim scope of the present invention.