CN114904128A - Cervical dilation and drug delivery system and use method - Google Patents
Cervical dilation and drug delivery system and use method Download PDFInfo
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- CN114904128A CN114904128A CN202210531431.5A CN202210531431A CN114904128A CN 114904128 A CN114904128 A CN 114904128A CN 202210531431 A CN202210531431 A CN 202210531431A CN 114904128 A CN114904128 A CN 114904128A
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/14—Female reproductive, genital organs
- A61M2210/1433—Uterus
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The invention relates to a cervix uteri expansion and drug administration system and a using method thereof, wherein the system consists of a cervix uteri expansion and drug administration device, a guide tee joint, a fluid infusion tube and an injector; the cervical dilatation and drug delivery device comprises a liquid injection pipe and a liquid injection bag, wherein the liquid injection bag comprises a front bag, a middle bag and a rear bag which are communicated with each other, and a front end opening is formed in the side wall of the front end of the liquid injection pipe; the tail end is provided with a connecting part; the guide tee joint comprises a first interface, a second interface and a third interface; the guide tee joint is used for vacuumizing, liquid injection and pressure maintaining, liquid supplementing for many times and liquid changing; the liquid supplementing pipe is used for storing or replacing liquid; the injector is used for extracting or injecting liquid into the liquid injection pipe; and a guide valve is arranged on the guide tee joint and used for controlling the connection or disconnection of the first connector, the second connector and the third connector.
Description
Technical Field
The invention relates to the technical field of gynecological medical instruments, in particular to a cervical dilatation and drug delivery system and a using method thereof.
Background
According to incomplete statistics, about 30 to 40 percent of pregnant women can not be in real labor naturally, various methods are needed for induction of labor, the cervical maturity needs to be evaluated before induction of labor, and if the cervix is immature, the vaginal delivery rate is obviously reduced, so that the cervical maturity and dilation are promoted by a mechanical or medicinal method, and the clinical significance is high.
In the prior art, the most common technique is balloon dilatation, in which a balloon is placed over the cervical os, the fetal membrane is mechanically peeled off, the balloon is dilated by injecting liquid into the balloon, and the balloon is taken out in a short time, generally within 12 hours, such as a disposable cervical dilatation balloon catheter disclosed in chinese patent publication No. CN 109663201B.
In addition, the drug can be administered orally or vaginally, and uterine contraction is induced by local absorption of the drug. The slow release administration mode comprises the following modes: U.S. patent publication No. US20220016398a1 discloses a drug film coating that breaks and dissolves when the balloon is inflated; chinese patent publication No. CN113398440A discloses opening a hole in the device, and discharging the medicament under pressure; patent publication No. WO2022052524a1 discloses that the drug is deposited in depressions with different heights, which are ruptured when the capsule expands, releasing the drug. Because the absorption degree and the sensitivity are different after the drug administration, the precise drug administration is difficult, the above drug slow release modes only can solve the problem of simple drug administration, the time of the drug administration can not be adjusted, and the drug change can not be carried out in the process.
The two modes of balloon and vaginal medicine application have advantages and disadvantages respectively, and a device for promoting cervical ripening by mechanical expansion and precise controlled medicine application at the same time is not seen in the prior art.
Disclosure of Invention
The invention aims to provide a cervical dilatation and drug delivery system and a using method, and solves the technical problems of how to promote cervical dilatation and drug delivery simultaneously or in a longer time.
The invention aims to solve the defects of the prior art and provides a cervical dilatation and drug delivery system, which consists of a cervical dilatation and drug delivery device, a guide tee joint, a fluid infusion tube and an injector; the cervical dilatation and drug delivery device comprises an injection tube and an injection sac, wherein the injection sac is fixed on a front end hot pressing fixing ring and a middle part hot pressing fixing ring on the injection tube through hot pressing; the liquid injection sac comprises three columnar sacs which are communicated with each other, the three columnar sacs are respectively a front sac, a middle sac and a rear sac, the front sac and the rear sac are oblate columnar and used for positioning and maintaining at a cervical orifice, the middle sac is long and round columnar, and the length of the middle sac is matched with the length of the cervix of an adult female and used for expanding the cervical orifice; the liquid injection pipe is of a hollow long-strip tubular structure, and a front end opening is formed in the side wall of the front end of the liquid injection pipe; the tail end of the liquid injection pipe is provided with a connecting part, and the end part of the connecting part is provided with an opening; the guide tee joint comprises a first interface, a second interface and a third interface; the first interface is connected with the opening; the second interface is connected with the liquid supplementing pipe; the third interface is connected with the injector; the guide tee joint is used for vacuumizing, injecting and maintaining pressure, supplementing liquid for many times and replacing liquid; the liquid supplementing pipe is used for storing or replacing liquid; the injector is used for extracting or injecting liquid into the liquid injection pipe; and the guide tee joint is provided with a guide valve for controlling the connection or disconnection of the first interface, the second interface and the third interface.
Preferably, the front end of the liquid injection pipe is conical.
Preferably, the liquid injection pipe is provided with a check valve at a position close to the tail part, and the check valve is used for preventing liquid from flowing back and air from entering.
Preferably, in the case of targeted drug delivery permeation, when the pressure in the capsule reaches a preset range, the holes on the capsule wall will be opened to form a semi-permeable membrane; the medicine molecules dissolved in the capsule permeate to the outside of the capsule through the holes on the capsule wall under the action of pressure, and infiltrate into tissues around the cervix; the high polymer outside the capsule can not permeate into the liquid injection capsule through the capsule wall, so that secondary pollution is avoided.
Preferably, in order to control accurate local administration, the front capsule, the rear capsule and the middle capsule are made of materials with different permeability.
Preferably, the front bag, the middle bag and the rear bag are fixed together through hot pressing, and the diameter of the hot pressing part is larger than that of the liquid injection pipe, so that the front bag and the rear bag are communicated.
Preferably, the front end of the front bag is provided with a front bag opening, the rear end of the rear bag is provided with a rear bag opening, and the front bag opening is hot-pressed on the front end hot-pressing fixing ring of the liquid injection pipe; the rear bag opening is hot-pressed on the hot-pressing fixing ring at the middle part of the liquid injection pipe.
Preferably, the front bag, the middle bag and the rear bag are made of elastic materials with different shapes, and the volume change amount of the front bag, the middle bag and the rear bag expanding along with the increase of the pressure is different.
Further preferably, the front bag, the rear bag and the middle bag of the liquid injection bag have different expansion coefficients and different expansion starting points along with the change of pressure; the front and back sacs play a role in fixation, and the middle sac plays a role in expansion.
The invention also provides a method for using the cervical dilatation and drug delivery system, which comprises two modes of non-drug delivery dilatation and targeted drug delivery infiltration, wherein the non-drug delivery dilatation is suitable for improving the cervical condition when the cervix of the pregnant woman is immature before delivery; the targeted drug delivery infiltration is suitable for simultaneous drug delivery in the process of promoting cervical ripening of a parturient so as to achieve the effect of promoting cervical ripening or local treatment;
the drug-free expansion comprises the following steps:
firstly, connecting and fastening a guide tee joint and a cervical dilatation and administration device through threads, and then connecting the guide tee joint by using an injector;
secondly, opening a guide valve of the guide tee joint, extracting the injector, extracting residual air in the cervical dilatation and administration device, rotating the guide valve, closing the first channel, opening the second channel and pushing the injector to discharge the extracted air; wherein the first channel is a channel between the liquid injection pipe and the injector; the second channel is a channel between the second interface of the guide tee and the injector;
thirdly, connecting a liquid supplementing pipe on a second interface of the guide tee joint, pulling the injector to extract liquid, rotating the guide valve, closing the second channel, opening the first channel, pushing the injector, and pushing the liquid into the cervical dilatation and administration device; the liquid in the fluid infusion tube does not contain a production process intervention medicament, and only contains physiological saline or liquid without specific functions;
fourthly, when the liquid required by the cervical dilatation and administration device is larger than the capacity of the syringe, repeating the step of the third step;
fifthly, when the pressure in the liquid injection sac reaches a preset maximum value or the uterine orifice is expanded to a limit, rotating the guide valve, and closing the first channel for pressure maintaining;
sixthly, when the uterine orifice expansion is no longer needed, the first channel is opened, the syringe is pulled to draw out the liquid in the cervical dilatation and administration device, and the liquid injection sac rebounds along with the release of the pressure and discharges the liquid;
the step of the targeted drug permeation is the same as the step of the non-drug expansion, and the liquid in the fluid supply pipe contains the birth process intervention medicament during the targeted drug permeation; when the pressure in the liquid injection bag adopted by targeted drug delivery permeation reaches a preset range, micropores on the bag wall are opened to form a semipermeable membrane; the medicine molecules dissolved in the capsule permeate to the outside of the capsule through the micropores on the capsule wall under the action of pressure, and infiltrate into tissues around the cervix; the high polymer outside the capsule can not permeate into the liquid injection capsule through the capsule wall, so that secondary pollution is avoided.
Preferably, the parturient based agent comprises: a tocolytic drug, an anti-infective drug, a lubricant, or a combination thereof.
Advantageous effects
Compared with the prior art, the invention has the beneficial effects that:
the cervix dilation and drug delivery system and the use method can play a role in cervix dilation, and can be matched with drugs for controlled release drug delivery; in response to the problem that the risk of infection may increase due to long balloon placement time, the associated risk may be reduced by local administration of sensitive antibiotics.
Drawings
The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention.
Fig. 1 is a schematic view of the cervical dilation and administration set of the present invention in an initial configuration.
Fig. 2 is a schematic structural view of the cervical dilatation and drug delivery device of the present invention in an infusion state.
FIG. 3 is a graphical representation of the amount of inflation of the front, rear and middle bladders of the infusion bladder of the present invention as a function of pressure.
Fig. 4 is a schematic structural view of the cervical dilation and delivery system of the present invention.
Detailed Description
The present invention is described in more detail below to facilitate an understanding of the present invention.
As shown in fig. 1 to 4, the cervical dilation and administration system of the present invention comprises a cervical dilation and administration apparatus 20, a guide tee 12, a fluid infusion tube 13 and a syringe 14; the cervical dilatation and drug delivery device 20 comprises an injection tube 1 and an injection sac 2, wherein the injection sac is fixed on a front end hot pressing fixing ring 10 and a middle part hot pressing fixing ring 11 on the injection tube through hot pressing; the liquid injection sac comprises three columnar sacs which are communicated with each other, the three columnar sacs are respectively a front sac 3, a middle sac 4 and a rear sac 5, the front sac 3 and the rear sac 5 are oblate columnar and used for positioning and maintaining at the cervical orifice, the middle sac 4 is long cylindrical, and the length of the middle sac 4 is matched with the length of the cervix of an adult female and used for expanding the cervical orifice; the liquid injection pipe is of a hollow long tubular structure, and a front end opening 7 is formed in the side wall of the front end of the liquid injection pipe; the tail end of the liquid injection pipe is provided with a connecting part 8, and the end part of the connecting part is provided with an opening 9 with threads; the guide tee 12 comprises a first interface, a second interface and a third interface; the first interface is connected with the threaded opening 9 in a plug-in mode of threaded fastening; the second interface is connected with the liquid supplementing pipe 13 in a plugging mode with threaded fastening; the third interface and the injector 14 are connected in a plug-in mode with thread fastening; the guide tee joint is used for vacuumizing, injecting and maintaining pressure, supplementing liquid for many times and replacing liquid; the liquid supplementing pipe 13 is used for storing or replacing liquid; the injector is used for extracting or injecting liquid into the liquid injection pipe; and the guide tee joint is provided with a guide valve 15 for controlling the connection or disconnection of the first interface, the second interface and the third interface.
Preferably, the front end of the liquid injection pipe is conical.
Preferably, the liquid injection pipe is provided with a check valve 6 at a position close to the tail part, and the check valve is used for preventing liquid from flowing back and air from entering.
Preferably, the threaded opening 9 at the end of the connection is able to be connected to a common syringe or to a guide tee.
Preferably, the liquid injection pipe is made of rubber, resin and other materials suitable for medical use, has certain hardness, and is convenient to place in the cervical orifice because the front end of the liquid injection pipe is conical.
Preferably, the front bag, the middle bag and the rear bag are fixed together through hot pressing, and the diameter of the hot pressing part is larger than that of the liquid injection pipe, so that the front bag and the rear bag are communicated.
Preferably, the front end of the front bag is provided with a front bag opening, the rear end of the rear bag is provided with a rear bag opening, and the front bag opening is hot-pressed on the front hot-pressing fixing ring 10 of the liquid injection pipe; the rear bag opening is hot-pressed on the middle hot-pressing fixing ring 11 of the liquid injection pipe.
Preferably, in the initial state, the liquid injection bag is in a vacuum shape and is attached to the surface of the liquid injection pipe, so that the liquid injection bag is convenient to place at the cervical orifice.
Preferably, the front bag, the middle bag and the rear bag are made of elastic materials with different shapes, and the volume change amount of the front bag, the middle bag and the rear bag expanding along with the increase of the pressure is different.
Further preferably, the front bag, the rear bag and the middle bag of the infusion bag have different expansion coefficients and expansion starting points along with the change of pressure, as shown in fig. 3; the front and back sacs play a role in fixation, and the middle sac plays a role in expansion.
When the pressure in the liquid injection sac reaches a certain value, the front sac and the rear sac basically do not increase along with the pressure, and the middle sac changes along with the pressure so as to meet the requirement of expanding the opening of the uterine orifice along with the progress of the labor process. Therefore, the compression and expansion sequence and the size of the front and the back bags and the middle bag are different, and the difference can better meet the requirement of the expansion of the uterine orifice.
When liquid is injected into the liquid injection sac, the liquid injection sac expands along with pressure, the front liquid injection sac and the rear liquid injection sac expand firstly to reach a given oblate cylindrical shape, and the cervical dilatation and administration device is fixed at the cervical orifice. Along with the increase of the liquid, the pressure in the sac is increased, the middle sac begins to swell, and the pressure is gradually applied to the cervix, so that the effect of expanding the uterine orifice is achieved.
The cervical dilation and drug delivery device provided by the invention has two using methods: (1) dilating the cervix; (2) and (4) administration.
The cervical dilatation and drug delivery system can simultaneously solve the problems of vacuumizing, drug delivery, drug supplement, drug change and the like in the drug delivery process.
The liquid injection pipe is of a long-strip tubular structure, the front end of the liquid injection pipe is conical, and a hole is formed in the position close to the front end. The liquid injection pipe is provided with a check valve near the tail part to prevent liquid from flowing back and air from entering. The tail end is provided with a connecting part, an opening and a thread are arranged in the connecting part, and the connecting part can be connected with a common injector or a guide tee.
The liquid injection pipe is made of rubber, resin, silica gel and other medical materials, has certain hardness, and is convenient to place in the cervical orifice due to the conical front end.
The liquid injection bag is set into three columnar bags which are mutually communicated, the two bags at the front end and the rear end are in oblate columns and are used for positioning and keeping at the cervical orifice, the middle bag is in a long column shape, and the length of the middle bag is matched with the length of the cervix of an adult female and is used for expanding the cervical orifice. The front bag, the middle bag and the rear bag are fixed together through hot pressing, and the diameter of the hot pressing part is larger than that of the liquid injection pipe, so that the front bag and the rear bag are communicated. The front end of the front bag is provided with an opening, the rear end of the rear bag is provided with an opening, and the openings are respectively hot-pressed on the front end part and the annular belt in the middle part of the liquid injection pipe.
In the initial state, the liquid injection bag is in a vacuum state and is attached to the surface of the liquid injection pipe, so that the liquid injection bag is convenient to place at the cervical orifice.
Preferably, the three bags of the infusion bag are made of elastic materials with different shapes, and the three bags are expanded along with pressure.
The front and rear bags and the intermediate bag of the infusion bag have different expansion coefficients and expansion starting points along with the change of pressure, as shown in figure 3. The front and back sacs play a role in fixation, and the middle sac plays a role in expansion.
When the pressure in the sacs reaches a certain value, the front and rear sacs basically do not increase along with the pressure, and the middle sac changes along with the pressure so as to meet the requirement of expanding the opening of the uterine orifice along with the progress of the labor process. Therefore, the compression and expansion sequence and the size of the front and the back bags and the middle bag are different, and the difference can better meet the requirement of the expansion of the uterine orifice.
When liquid is injected into the liquid injection sac, the liquid injection sac expands along with pressure, the front liquid injection sac and the rear liquid injection sac expand firstly to reach a given oblate cylindrical shape, and the cervical dilatation and administration device is fixed at the cervical orifice. Along with the increase of the liquid, the pressure in the sac is increased, the middle sac begins to swell, and the pressure is gradually applied to the cervix, so that the effect of expanding the uterine orifice is achieved.
The cervical dilation and administration system of the invention comprises a cervical dilation and administration device, a guide tee joint, a fluid infusion tube, an injector and the like, and is shown in figure 4. The injector, the liquid supplementing pipe and the guide tee joint, and the guide tee joint and the cervical dilatation and administration device are connected in a threaded fastening insertion mode, the injector is used for extracting or injecting liquid into the liquid injection pipe, the liquid supplementing pipe is used for storing or replacing the liquid, and the guide tee joint is provided with a guide valve used for controlling the connection or disconnection of a liquid passage.
Alternatively, when a pilot valve is provided, a check valve at the rear end of the pour tube is not necessarily provided.
The main functions of the guide tee are as follows:
(1) and (6) vacuumizing. It is difficult to ensure a complete vacuum when the cervical dilation and administration device is shipped, and once air enters the body, serious problems can result.
(2) And injecting liquid and maintaining pressure. The injection channel (the injection pipe < - - > injector, namely the channel between the injection pipe and the injector is the injection channel) is opened through the guide valve, the injection is carried out, the injection is stopped when a certain pressure is reached, and the guide valve is closed to keep the pressure.
(3) Multiple times of fluid infusion. When the injection dosage is not enough, the injector does not need to be drawn out or inserted, thereby being convenient for pressure maintaining and avoiding air mixing.
(4) And (6) changing the liquid. The liquid in the cervical dilatation and administration device is pumped out by the injector, removed and the liquid supplementing tube with the liquid medicine is replaced, thus the liquid can be replaced.
A liquid injection channel (a liquid injection pipe < - > injector, namely a channel between the liquid injection pipe and the injector is a liquid injection channel) is defined as a first channel, and a liquid supplementing channel (a liquid supplementing pipe < - > injector, namely a channel between the liquid supplementing pipe and the injector is a liquid supplementing channel) is defined as a second channel.
With the function of the pilot valve different, the position of use is shown in the following table:
the method for using the cervical dilatation and drug delivery system comprises two modes of non-drug delivery dilatation and targeted drug delivery infiltration, and is specifically described in the following two examples.
EXAMPLE one, No expansion by drug administration
The non-administration dilatation is suitable for improving cervical condition of pregnant women when cervix is immature before delivery.
In this case, the liquid in the infusion tube does not contain a midwifery intervention drug, and generally contains only physiological saline or a liquid having no specific function.
The liquid injection process is as follows:
(1) the guide tee joint and the cervical dilatation and drug delivery device are connected and fastened through threads, and then the guide tee joint is connected through an injector.
(2) Opening a guide valve of the guide tee joint, extracting the syringe, extracting residual air in the cervical dilatation and drug delivery device, rotating the guide valve, closing the first channel, simultaneously opening the second channel, and pushing the syringe to discharge the extracted air.
(3) And the second channel is connected with a liquid supplementing pipe, after the syringe is pulled to extract liquid, the guide valve is rotated, the second channel is closed, meanwhile, the first channel is opened, the syringe is pushed, and the liquid is pushed into the cervical dilatation and administration device.
(4) When the syringe capacity is small and the cervix dilation and administration device requires more liquid, step (3) is repeated.
When the liquid is injected into the cervical dilatation and administration device, the liquid injection bags expand along with the pressure generated by the increase of the liquid, the front and the rear liquid injection bags expand firstly to reach the preset flat cylindrical shape, the clamping is carried out at the uterine orifice and the fornix, and the cervical dilatation and administration device is fixed at the cervical orifice. The continuous administration increases the pressure in the sac along with the continuous increase of the liquid, the middle sac begins to swell, and the pressure is gradually applied to the cervix so as to achieve the effect of expanding the uterine orifice.
(5) And when the pressure reaches a preset maximum value or the uterine orifice is expanded to the limit, rotating the guide valve, and closing the first passage to maintain pressure.
(6) When the expansion of the uterine orifice is no longer needed, the first channel is opened, the syringe is pulled to extract the liquid of the cervical dilatation and drug delivery device, and the liquid injection sac rebounds along with the release of the pressure and discharges the liquid.
When the non-drug-administration expansion is adopted, the material of the infusion bag is not limited by the material characteristics of the targeted drug administration permeation.
Example two, targeted drug delivery permeation
The targeted drug penetration is suitable for simultaneous drug administration in the process of promoting cervical ripening of puerpera so as to achieve the effect of promoting cervical ripening or local treatment. The administration mode can independently allocate the titer and the slow release time of the medicament according to individual difference, and can be adjusted in real time along with the cervical dilatation, namely, the cervical dilatation and the administration function are considered at the same time.
The liquid injection bag is made of one or more materials such as silicon rubber, silicon-fluorine rubber, ethylene propylene rubber, polyurethane, polyethylene, polypropylene or polytetrafluoroethylene, has a film shape and elasticity, can separate substances with different molecular weights, and is a characteristic of targeted drug delivery and permeation.
The liquid injection bag expands under the condition of liquid injection, and when the liquid injection bag expands to a certain degree and the pressure in the bag meets a certain range (for example, the pressure is 0.2M-0.8 MPa), micropores on the bag wall are opened to form a semipermeable membrane. The drug molecules dissolved in the capsule, with the solute having a molecular weight within a certain range (e.g., <400 daltons), will permeate under pressure through the micropores in the capsule wall to the outside of the capsule, infiltrating the tissue around the cervix. The high molecules containing amniotic fluid, blood, body fluid and the like outside the capsule can not permeate into the liquid injection capsule through the capsule wall (the size of the high molecules is larger than that of micropores on the capsule wall after the liquid injection capsule is expanded), so that secondary pollution is avoided.
The materials of the liquid injection bags are different, and the permeability and the release rate are different. Preferably, in order to control accurate local administration, the front capsule, the rear capsule and the middle capsule can be made of materials with different permeability.
The step of targeted drug delivery and permeation is basically the same as the step of liquid injection without drug delivery and expansion, and the liquid in the fluid infusion tube contains the medicament for parturition intervention; in order to ensure the continuous permeation, continuous fluid infusion and pressure maintaining are needed in the fluid injection bag; the medicine can be changed in the middle of the course according to the requirement.
Optionally, the guide valve is used in combination to open or close the first channel and the second channel, so as to conveniently replace the liquid medicine in the cervical dilatation and administration device.
The parturient intervention type agents include intervention drugs and lubricants, and there are two main types of intervention drugs: uterine contraction-promoting drugs and anti-infective drugs, the most common drugs, such as misoprostol and metronidazole.
(1) Uterine contraction promoting medicine
The existing local administration dosage form for promoting uterine contraction, such as prostaglandin E2 suppository, is a controlled release system which releases prostaglandin E2 at a constant speed of 0.3mg per hour, but clinically, cases with strong uterine contraction are seen, even adverse fates are caused, and local administration is assisted by matching with injection sac expansion, so that the dosage of the drug for promoting uterine contraction can be reduced, and related risks are reduced.
The common clinical medicine for promoting uterine contraction is misoprostol, the molecular weight of the misoprostol is 282, the medicine is slowly released by adopting the device, the injection capsule forms a semipermeable membrane, when the pressure in the capsule reaches 0.6MPa, the misoprostol can slowly permeate out through the semipermeable membrane, the release rate after 2 hours is about 60 percent, and the release rate after 4 hours is about 90 percent.
(2) Anti-infective agents
The risk of infection during childbirth is increased by the bacterial culture of the cervix, if pathogenic bacteria are present, so that in certain cases antibiotics, such as metronidazole, with a molecular weight of 171, can be applied topically. In the prior art, the pessary is generally adopted for slow release, local application at the cervix cannot be formed, and the titer of the medicament cannot be prepared according to individual difference.
Adopt this device slowly-releasing to administer, annotate the liquid bag and form the pellicle, when pressure reached 0.4MPa in the bag, metronidazole can permeate away through the pellicle slowly, and the release rate after 0.5 hour is 70%, and the release rate of 2 hours is 90%.
(3) Lubricant agent
The device can simply promote the delivery of the fetus during delivery, and can also be used as a drug delivery liquid by adding a lubricant into physiological saline to infiltrate and slowly release the lubricant. The molecular weight of the lubricant for childbirth is about 260-320 generally, the lubricant is slowly released by adopting the device, when the pressure of the injection sac reaches 0.4-0.7 MPa, the lubricant can slowly permeate out through a semipermeable membrane, and the release rate after 2 hours is about 50-70%.
The foregoing describes preferred embodiments of the present invention, but is not intended to limit the invention thereto. Modifications and variations of the embodiments disclosed herein may be made by those skilled in the art without departing from the scope and spirit of the invention.
Claims (10)
1. A cervix uteri expansion and drug delivery system is characterized in that the cervix uteri expansion and drug delivery system consists of a cervix uteri expansion and drug delivery device, a guide tee joint, a fluid infusion tube and an injector; the cervical dilatation and drug delivery device comprises an injection tube and an injection sac, wherein the injection sac is fixed on a front end hot pressing fixing ring and a middle part hot pressing fixing ring on the injection tube through hot pressing; the liquid injection bag comprises three columnar bags which are communicated with each other, the three columnar bags are respectively a front bag, a middle bag and a rear bag, the front bag and the rear bag are oblate columnar and are used for positioning and maintaining the front bag and the rear bag at the cervical orifice, and the middle bag is in a long column shape and is used for expanding the cervical orifice; the liquid injection pipe is of a hollow long-strip tubular structure, and a front end opening is formed in the side wall of the front end of the liquid injection pipe; the tail end of the liquid injection pipe is provided with a connecting part, and the end part of the connecting part is provided with an opening; the guide tee joint comprises a first interface, a second interface and a third interface; the first interface is connected with the opening; the second interface is connected with the liquid supplementing pipe; the third interface is connected with the injector; the guide tee joint is used for vacuumizing, liquid injection and pressure maintaining, liquid supplementing for many times and liquid changing; the liquid supplementing pipe is used for storing or replacing liquid; the injector is used for extracting or injecting liquid into the liquid injection pipe; and the guide tee is provided with a guide valve for controlling the connection or disconnection of the first connector, the second connector and the third connector.
2. The cervical dilation and administration system of claim 1, wherein the front end of the infusion tube is conical.
3. The cervical dilation and administration system according to claim 1, wherein the filling tube is provided with a check valve at a position near the tail portion for preventing liquid backflow and air entrance.
4. The cervical dilation and administration system according to claim 1, wherein in the case of targeted drug penetration, when the pressure in the sac reaches a predetermined range, the micro-pores on the sac wall will open to form a semi-permeable membrane; the drug molecules dissolved in the capsule penetrate to the outside of the capsule through the micropores on the capsule wall under the action of pressure and infiltrate into tissues around the cervix; the high polymer outside the capsule can not permeate into the liquid injection capsule through the capsule wall, so that secondary pollution is avoided.
5. The cervical dilation and administration system of claim 1, wherein the anterior capsule, the posterior capsule and the medial capsule are selected from materials having different permeabilities for controlled precise local administration.
6. The cervical dilation and administration system according to claim 1, wherein the anterior sac, the middle sac and the posterior sac are fixed together by a heat pressing, and the diameter of the heat pressing part is larger than that of the liquid injection tube, so as to ensure the front and back communication of the three sacs.
7. The cervical dilation and drug delivery system according to claim 6, wherein the front end of the front balloon is provided with a front balloon opening, the rear end of the rear balloon is provided with a rear balloon opening, and the front balloon opening is heat pressed on the front end heat pressing fixing ring of the infusion tube; the rear bag opening is hot-pressed on the middle hot-pressing fixing ring of the liquid injection pipe.
8. The cervical dilation and administration system according to claim 1, wherein the anterior capsule, the middle capsule and the posterior capsule are made of elastic materials with different shapes, and the volume change of the anterior capsule, the middle capsule and the posterior capsule is different as the pressure is increased; the expansion coefficients and the expansion starting points of the front bag, the rear bag and the middle bag of the liquid injection bag along with the pressure change are different; the front and back sacs play a role in fixation, and the middle sac plays a role in expansion.
9. A method of using the cervical dilation and administration system according to any one of claims 1 to 8, wherein the method of use includes both non-administration dilation and targeted administration penetration, wherein said non-administration dilation is suitable for use in improving cervical conditions in pregnant women when the cervix is immature prior to delivery; the targeted drug delivery infiltration is suitable for simultaneous drug delivery in the process of promoting cervical ripening of a parturient so as to achieve the effects of promoting cervical ripening or local treatment;
the non-drug-administration expansion comprises the following steps:
firstly, connecting and fastening a guide tee joint and a cervical dilatation and administration device through threads, and then connecting the guide tee joint by using an injector;
secondly, opening a guide valve of the guide tee joint, extracting the injector, extracting residual air in the cervical dilatation and administration device, rotating the guide valve, closing the first channel, opening the second channel and pushing the injector to discharge the extracted air; wherein the first channel is a channel between the liquid injection pipe and the injector; the second channel is a channel between the second interface of the guide tee and the injector;
thirdly, connecting a liquid supplementing pipe on a second interface of the guide tee joint, pulling the injector to extract liquid, rotating the guide valve, closing the second channel, opening the first channel, pushing the injector, and pushing the liquid into the cervical dilatation and administration device; the liquid in the fluid infusion tube does not contain a production process intervention medicament, and only contains physiological saline or liquid without specific functions;
fourthly, when the liquid required by the cervical dilatation and administration device is larger than the capacity of the injector, repeating the step of the third step;
fifthly, when the pressure in the liquid injection sac reaches a preset maximum value or the uterine orifice is expanded to a limit, rotating the guide valve, and closing the first channel for pressure maintaining;
sixthly, when the uterine orifice expansion is no longer needed, the first channel is opened, the syringe is pulled to draw out the liquid in the cervical dilatation and administration device, and the liquid injection sac rebounds along with the release of the pressure and discharges the liquid;
the step of the targeted drug permeation is the same as the step of the non-drug expansion, and the liquid in the fluid supply pipe contains the birth process intervention medicament during the targeted drug permeation; when the pressure in the liquid injection bag adopted by targeted drug delivery permeation reaches a preset range, micropores on the bag wall are opened to form a semipermeable membrane; the medicine molecules dissolved in the capsule permeate to the outside of the capsule through the micropores on the capsule wall under the action of pressure, and infiltrate into tissues around the cervix; the high polymer outside the capsule can not permeate into the liquid injection capsule through the capsule wall, so that secondary pollution is avoided.
10. The method of use of claim 9, wherein the partum intervention class agent comprises: a tocolytic drug, an anti-infective drug, a lubricant, or a combination thereof.
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