CN109928062B - Condom system and packaging method thereof - Google Patents

Condom system and packaging method thereof Download PDF

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Publication number
CN109928062B
CN109928062B CN201910018430.9A CN201910018430A CN109928062B CN 109928062 B CN109928062 B CN 109928062B CN 201910018430 A CN201910018430 A CN 201910018430A CN 109928062 B CN109928062 B CN 109928062B
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Prior art keywords
condom
container
pressure
hard
rolled
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CN201910018430.9A
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CN109928062A (en
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李华智
袁永玲
卢智俊
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Guangzhou Wanfangjian Medicine Co ltd
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Guangzhou Wanfangjian Medicine Co ltd
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Priority to CN201910018430.9A priority Critical patent/CN109928062B/en
Priority to CN202110646228.8A priority patent/CN113353448B/en
Publication of CN109928062A publication Critical patent/CN109928062A/en
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • B65D75/367Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming several compartments
    • B65D75/368Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming several compartments the compartments being interconnected, e.g. by small channels

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  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Packages (AREA)

Abstract

The invention discloses a condom system, which comprises a rolled condom and a container, wherein the rolled condom is arranged in the container and comprises a lantern ring, a female side and a male side which are mutually isolated; the invention also discloses a packaging method of the condom system, which comprises the following steps: adding the agent "asymmetrically" within the condom and/or container; isolating the male and female sides of the condom; and sealing the condom within the container; after sealing, the rolled condom has its collar and/or mantle subjected to pressure. According to the condom system provided by the invention, reagents which are added asymmetrically in the condom system before sealing can be greatly reduced, and mutual migration between spaces at two sides of a rolled condom in the processes of carrying and storing can be realized; after long-time storage, reagents on two sides of the condom obviously keep an asymmetric state before sealing, and different requirements of women and men are met.

Description

Condom system and packaging method thereof
Technical Field
The present invention relates to the field of condoms, and more particularly to a condom system and method of packaging the same that reduces the migration of agents that are "asymmetrically" added to the condom system prior to sealing between the female and male (unless otherwise specified, either side is referred to as "one side" and both are collectively referred to as "both sides") spaces of a rolled condom during handling and storage. After the condom system is carried and stored for a long time, the female side and the male side of the condom are kept in a good isolation state, and reagents on the two sides of the condom are obviously kept in an asymmetric state before sealing, so that the requirements of the female and the male on the asymmetry of functions can be met respectively.
Background
Condoms are widely used in human sexual life and their general functions include contraception, protection against cross-infection by HIV (human immunodeficiency virus) and various sexually transmitted disease agents. The rolled condom (as shown in fig. 1) comprises a closed end 1 of the mantle, and a collar 2 formed by rolling a portion of the mantle, wherein the mantle at the closed end is divided into a female side 3 (the outside of the mantle in contact with the vaginal canal or the female) and a male side 4 (the inside of the mantle in contact with the male penis). The collar 2 when placed with the female side up is divided into an upper side 5, a lower side 6, an inner side 7 and an outer side 8. The inner perimeter of the lantern ring refers to the length of a closed curve formed on the inner side of the lantern ring, and the inner diameter of the lantern ring refers to the diameter corresponding to the inner perimeter when the lantern ring is a perfect circle; wherein the outer circumference of the lantern ring refers to the length of a closed curve formed outside the lantern ring, and the outer diameter of the lantern ring refers to the diameter corresponding to the outer circumference when the lantern ring is a perfect circle; wherein the diameter of the collar is the diameter of the cross section of the collar.
When using condoms in sexual life, women and men have different appeals for various purposes such as convenience of wearing, facilitation of sexual performance, prevention of infection, improvement of erectile function, prolongation of erectile time, enhancement of libido, and so on, and thus, they have different appeals for the amount and kind of agents on the female side and the male side when using condoms, which we call "asymmetric" functions.
These agents having a certain function may be administered in the form of a human lubricant or a pharmaceutical form (suppository, gel, tablet, etc.) which is packed separately, or the like. But for ease of use, direct addition into a condom or condom packaging system is clearly a better option.
The current method of adding condom lubricant is to add a certain amount and kind of lubricant to one side of the rolled condom or to the packaging material, and then to seal the rolled condom in the packaging material. There are also other methods of adding the agent, such as for anti-premature ejaculation agents, which are directly added in liquid or semi-solid state on the male side. In the prior art packaging technique, there is only one communicating space within the entire sealed package, and the male and female sides of the condom are not isolated from each other. Thus, during transport and storage, the agent added to either the female or male side will gradually migrate to the other side, and after several weeks this migration will approach 50%, i.e. the agent species and amount on both sides will tend to be consistent (i.e. "symmetrical"). As a result, no matter how "asymmetric" the initial state of the lubricant on the female and male sides of the condom prior to sealing is, upon storage for weeks into the consumer's hand, the reagents on both sides of the condom have already tended to be "symmetric", failing to satisfy the "asymmetric" appeal of male and female to the function (e.g. lubrication) of both sides of the condom.
In order to overcome the above technical problems, and to provide a condom having a distinct "asymmetrical" function and effect when used by the consumer, the skilled person has made various attempts:
european union patent EP1003448B1 discloses a design with an adhesive layer on the male side of the condom open end and a non-adhesive layer on the female side of the open end; the adhesive layer provides better adhesion of the condom to the penis while avoiding slippage, and the non-adhesive layer prevents the adhesive composition from adhering to the female side. However, the sticky components can cause user discomfort, make the sleeve difficult to roll well, and increase the risk of affecting the quality of the sleeve.
US4930522A discloses a device useful as a condom having a microcapsule of an anti-infective active substance affixed between two layers of elastomeric material; in use, the microcapsules are ruptured by friction to release the active substance. However, the absence of lubricant on the male side can lead to wearing difficulties, and the pressure created by rolling up the condom, external forces during delivery, etc. can stress the microcapsule wall leading to premature release of the active substance.
Chinese patent CN104921862B discloses a condom with a properly lubricated inner surface, which aims to prevent looseness and smoothness and is convenient to wear, and improves the satisfaction of users, however, the condom needs to coat the lubricant on the inner surface and the outer surface of the mantle for many times, the efficiency is low, and the use is not convenient. Therefore, there is a need for a condom system that reduces the migration of agents from one another on both sides of the condom, particularly in that the condom maintains "asymmetrical" functionality on both the female and male sides even after prolonged transport and storage when the condom is removed and used.
Disclosure of Invention
Based on the technical problems, in order to overcome the defects of the prior art, the invention provides a condom system and a packaging method thereof, the condom system provided by the invention can reduce reagent which is added asymmetrically in the condom system before sealing, and mutual migration between the female side space and the male side space of the rolled condom during the transportation and storage process; when the condom system is taken out and used after being carried and stored for a long time, the rolled condom keeps a good isolation state between the female side and the male side, and reagents on the female side and the male side of the condom obviously keep an asymmetric state before sealing, so that the asymmetric requirements of women and men on certain functions can be met respectively. The condom body is convenient to use.
In order to achieve the purpose, the invention adopts the technical scheme that:
a condom system comprising a rolled condom and a container within which the rolled condom is disposed, the rolled condom comprising a condom ring, a female side and a male side of a condom film which are isolated from one another. The space in the container is divided into at least two isolated spaces, and the male side and the female side are respectively located in different isolated spaces. Thus, the mutual migration of agents on the female and male side can be reduced, and over a long period of time the condom is transported and stored, removed from the container and used, the condom still retains the female and male side 'asymmetric' agents and their functionality. It should be noted that the addition of the reagent to the female side or the male side in the present embodiment means, unless otherwise specified, addition to the space where the side is located; the term "asymmetric" addition, as used herein, means that the amount and/or type of reagent added to the female side and the male side are different from each other in the isolated female side space.
In this embodiment, the term "connecting" between the condom and the receptacle means that at least one or more sides of the collar and/or the mantle membrane are in close contact with one or more locations in the receptacle or a component (e.g., a ring-shaped protrusion, a ring-shaped groove, a rigid plate, etc.) in the receptacle or receptacle, thereby isolating the female side and the male side of the condom to reduce migration of the agent between the two sides of the condom.
The term "fixedly attached" as used herein means that the cylindrical protrusion, the annular groove and/or the rigid plate are integrally formed with the container.
The column-shaped bulge is a solid formed by at least one curved surface and/or plane, and the outer contours and the sizes of different horizontal sections of the column-shaped bulge can be changed.
Preferably, the collar and/or sleeve membrane is connected to the container to form the female and male sides of the condom in isolation from each other. The condom or container can be respectively added with appropriate pigment, essence, herba Menthae, insoluble particulate matter or suspended matter, heating or cooling material, etc.
Preferably, the rolled condom and/or container has an agent added thereto, which may be one or more of a lubricant, an anti-HIV agent, an anti-erectile dysfunction agent, an anti-premature ejaculation agent, an anti-infective agent, a haemostatic agent, an anti-epidermal mucosal damage agent, a libido enhancement agent, a sensitising agent, a health care agent. The lubricant can be one or more of water-soluble lubricant, oil-soluble lubricant, various emulsions formed by water and oil (including common emulsion, submicroemulsion and microemulsion), gel, soft capsule, suppository and solid preparation; the lubricant may contain polymers of varying molecular weights, such as one or more of dextran, cellulose, gums, pectins or pectins, bosom, calcium polycarbophil, hyaluronic acid, proteins, chitosan-containing extracts, aloe vera extracts, cell lysates, biologically safe oil matrices (such as silicone oils and their derivatives, castor oil, etc.), pharmaceutically acceptable sustained and controlled release materials, and the like.
Preferably, the condoms of the invention contain different amounts and/or types of agents on the female and male sides. The amount of the reagent on the female side is preferably 0.3 to 2.5ml, and the amount of the reagent on the male side is preferably 0 to 0.2 ml. The pH of the female side agent is preferably 3.8 to 5.8, and the pH of the male side agent is preferably 6.0 to 8.0.
Preferably, the anti-HIV agent is an agent having anti-HIV invasion, reverse transcription, intercalation, transcription, translation, assembly, etc. in vitro and in vivo or an agent inactivating HIV or an agent adsorbing HIV particles, including tenofovir, zidovudine, stavudine, dehydroxyglycoside, lamivudine, nevirapine, indinavir, efavirenz, terluwada, dolutegravir, complai, lativelawk, direiravir, vireid, activated carbon, resins, macromolecules with multiple branch terminal groups and their derivatives and/or one or more combinations of salts, zinc salts, sulfonates, etc.
Preferably, the anti-erectile dysfunction agent refers to an agent for improving erectile dysfunction in vitro, and comprises one or more combinations of PDE inhibitor drugs (such as sildenafil, tadalafil, vardenafil, avanafil, udenafil, milonafil), prostaglandins (such as alprostadil), yohimbine, extracts (such as extracted from traditional Chinese medicines, plants and animal tissues) and derivatives and/or salts thereof.
Preferably, the anti-premature ejaculation agent refers to an agent having anti-premature ejaculation or ejaculation delaying activity, and comprises one or more of lidocaine, benzocaine, bupivacaine, benzocaine, fluoxetine, paroxetine, duloxetine, dapoxetine, sertraline, estaphtalopram, extracts (such as extracted from traditional Chinese medicine, plants and animal tissues) and derivatives and/or salts thereof.
Preferably, the anti-infective agent is an agent having antibacterial (including bacteria, fungi, chlamydia, mycoplasma, trichomonas, parasites, viruses other than HIV such as HPV, CMV, HSV, hepatitis virus, etc.) or bacteriostatic activity, including miconazole, clotrimazole, butoconazole, fenticonazole, econazole, metronidazole, nifuratel, isoconazole, sertaconazole, terconazole, fluconazole, voriconazole, itraconazole, posaconazole, isavuconazole, oxiconazole, sulconazole, eidoconazole, itraconazole, naftifine, micaceponin, caspofungin, nystatin, amphotericin B, povidone iodine, tioconazole, clindamycin phosphate, ornidazole, lactein, ciprofloxacin, matrine, ciclopirox olamine, polymetaphrenol aldehyde, bifonazole, snake yellow, stilbengal, purofen, chlorazol, bitomycins, bitiacin, and the like, One or more combinations of recombinant human interferon, chlorhexidine, terbinafine and derivatives and/or salts thereof.
Preferably, the hemostatic agent is an agent having a local hemostatic effect, such as tranexamic acid, Yunnan white drug powder, hemostatic powder, and the like.
Preferably, the container comprises a flexible pouch; alternatively, the container is made of a hard material; alternatively, the container comprises a rigid box made of a hard material; alternatively, the container comprises a rigid case and a flexible pouch. Preferably, the container comprises a rigid box and a lid. The hard box body and the cover can be sealed by conventional methods such as heating, pressurizing, buckling, gluing and the like.
The packaging material for manufacturing the condom can adopt the packaging material of medical instruments, and can be a hard packaging material which does not deform greatly in a given pressure range and is connected with a rolled condom lantern ring and/or a condom film, such as a plastic plate, a novel polymer material plate, a metal plate, a high-strength paperboard, a rubber plate, a silica gel plate, a composite material with soft part and hard skeleton and the like; or flexible packaging materials which are easily deformable so as to be in relatively uniform contact with the rolled condom, such as plastic films, composite plastic films, cellophane, metal foils or sheets, and composite films thereof, or materials which are made of relatively hard materials which are folded or otherwise processed so as to be easily deformable in the sealed region, while otherwise locally retaining the material which is not easily deformed to a great extent, and the like.
Preferably, a groove for placing a condom is formed in the hard box body, and the diameter of the lantern ring is larger than the height of the groove. Thus, when the lid is sealed to the rigid body, the collar and/or mantle may be squeezed to effect separation between the female and male sides of the condom, to reduce the migration of "asymmetrically" added reagents between the rolled condom sides.
Preferably, the container comprises a soft bag and a hard box body with a multi-layer structure, the rolled condom is arranged in the soft bag, and the diameter of the lantern ring is larger than the distance between every two layers.
Preferably, a columnar protrusion is arranged in the container, and the lantern ring is sleeved on the columnar protrusion. Whereby the collar or the collar and sleeve membrane are attached to the surface of the cylindrical protrusion thereby isolating the female and male sides of the condom to reduce the migration of "asymmetrically" added agents between the rolled condom sides.
Preferably, at least one protrusion or indentation is arranged on the side wall of the columnar protrusion. More preferably, the top edge of the columnar protrusion has at least one outward protrusion. More preferably, the vertical surface of the inner side wall of the annular groove is provided with an invagination, so that the lantern ring can be more stably fixed on the columnar protrusion. More preferably, the side wall of the columnar bulge is provided with at least one inward recess, the distance between the inward recess and the diameter of the lantern ring is the same, and a column is arranged to enable the lantern ring to be tightly squeezed at the inward recess. Thereby, the collar can be prevented from slipping off the stud projection.
Preferably, the outer contour of the horizontal section of the columnar bulge is a closed curve, a polygon or a closed shape formed by connecting a curve and a straight line. More preferably, the columnar protrusion is one or more of a rotating body (including a cylinder, a truncated cone, a hemisphere, etc.), a cylinder (including an elliptic cylinder, a prism, a truncated pyramid, etc.).
Preferably, the columnar protrusions have a concave structure in the middle. Thus, agents may be added to the depression and/or a film of a condom may be placed.
Preferably, the bottom of the columnar projection is provided with at least one handle for facilitating the removal of the condom.
Preferably, the columnar protrusion is fixedly connected with the container.
Preferably, the outer perimeter of the columnar projections is greater than or equal to the inner perimeter of the collar.
Preferably, the container comprises an annular groove structure, the collar being embedded within the annular groove. Thus, the annular groove joins the inside and outside of the collar, thereby isolating the female and male sides of the condom to reduce the migration of "asymmetrically" added agents from one another between the two sides of the rolled condom.
The diameter of the condom ring is the average value of the diameter of the cross section of the condom ring, and the measuring method is that 20 condoms are taken, after the condoms are fully rolled, 10 points are uniformly selected for each condom ring to be subjected to contact measurement, and the average value of the measured values is the diameter of the condom ring.
Preferably, the side wall of the annular groove is provided with at least one protrusion or indentation. More preferably, the outer side wall of the annular groove is provided with at least one protrusion towards the groove. More preferably, one side wall of the annular groove is provided with at least one recess, and the other side wall is correspondingly provided with the protrusion with a complementary shape, so that the lantern ring is squeezed at the recess. Thereby, the condom is further prevented from falling out of the annular groove.
Preferably, the inner contour of the horizontal section of the annular groove is a closed curve, a polygon, or a closed shape formed by connecting a curve and a straight line.
Preferably, the inner wall of the annular groove extends upwards to form a columnar bulge, and a concave structure is arranged in the middle of the columnar bulge.
Preferably, the annular groove is fixedly connected with the container.
Preferably, one part of the annular groove extends outwards to form a valley; thereby, the condom can be conveniently taken out. More preferably, the bottom of the valley is lower than the bottom of the annular groove. More preferably, the valley is a slope, and the volume of the valley may be reduced. More preferably, the valley is a shallow groove-like valley, extends to the outside of the annular groove through the bottom of the annular groove, and a string or a hook can be placed in the valley, and the condom can be conveniently taken out by pulling the string or the hook.
Preferably, the width of the annular groove is less than or equal to the diameter of the collar +1.5 mm. Due to the wide variation in condom crimp size, average condom film thickness and thickness uniformity, the diameter of the rolled condom ring is not uniform at each point between condoms and within the same condom. The inventor finds that the maximum fluctuation range of the diameter of the lantern ring does not exceed 1.5mm through multi-point measurement and statistical analysis of a large number of samples. In addition, in the production process, on the premise of ensuring that the condom ring is well connected with the annular groove, in order to ensure the production efficiency of the packaging link and reduce the probability that the condom ring is not well embedded into the annular groove, the width of the annular groove needs to be set to be less than or equal to the diameter of the condom ring plus 1.5 mm.
Preferably, the outer wall and/or the inner wall of the annular groove are formed by arranging a plurality of columnar protrusions, and a gap is formed between two adjacent columnar protrusions in the plurality of columnar protrusions. Preferably, the columnar protrusion is one or more of a cylinder, an elliptic cylinder, a prism, a table, an arc-shaped cylinder and the like. Preferably, the plurality of columnar protrusions are annularly arranged into an inner layer and an outer layer, and the lantern ring is arranged between the annularly arranged columnar protrusions of the inner layer and the outer layer, so that the female side and the male side of the condom are isolated. More preferably, the plurality of stud bumps are fixedly connected with the container.
More preferably, the container is a hard box body, an annular groove structure is fixedly connected in the hard box body, the bottom of the annular groove is arc-shaped, the inner wall of the annular groove extends upwards to form a columnar protrusion, a concave structure is arranged in the middle of the columnar protrusion, at least one protrusion is arranged on the side wall of the annular groove, one part of the annular groove extends outwards to form an inclined plane valley, and the bottom of the inclined plane valley is lower than the bottom of the annular groove.
More preferably, the container is a hard box body, an annular groove structure is fixedly connected in the hard box body, the bottom of the annular groove is arc-shaped, the inner wall of the annular groove extends upwards to form a columnar protrusion, a concave structure is arranged in the middle of the columnar protrusion, at least one protrusion is arranged on the side wall of the annular groove, a trough in a shallow groove shape is arranged at one position of the annular groove through the bottom, the outwards extending side of the trough extends out of the annular groove, and a rope belt or a hook can be placed in the trough in the shallow groove shape.
Preferably, a hard plate is arranged in the container, and each surface of the hard plate can be a plane and/or a curved surface respectively. The hard plate is connected with at least one of the upper side, the lower side, the inner side, the outer side, the mantle female side and the mantle male side of the condom lantern ring. Thus, when a rigid sheet is attached to one side of the collar and/or the sleeve membrane, isolation between the female and male sides of the condom is achieved to reduce the migration of "asymmetrically" added agents between the rolled condom sides.
Preferably, the hard plate has a hollow structure, and the collar is connected to an inner side of the hard plate.
Preferably, the hard plate has a recessed structure that can accommodate reagents.
More preferably, the hard plate is fixedly connected with the hard box body.
More preferably, the rigid panel, which is placed on one side of the rolled condom, is fixedly connected to the container, which is placed on the other side of the rolled condom.
Preferably, there is pressure between the collar and/or sleeve membrane and the container; more preferably, the pressure value is 0.196-98N; most preferably, the pressure value is 0.490-49N.
Preferably, the pressure inside the container is less than the pressure outside the container; more preferably, the pressure inside the container is 0.002-0.095 MPa less than the pressure outside the container; most preferably, the pressure inside the container is 0.005 to 0.090 megapascals less than the pressure outside the container. The collar and the mantle are thus subjected to the above-mentioned pressure.
The present inventors have found, after numerous trials, that when the collar and/or the mantle is subjected to a pressure within the above-mentioned range, the female side and the male side of the condom are isolated from each other, which effectively reduces the mutual migration of the agent between the female side and the male side of the condom, and that the condom system maintains the "asymmetry" of the agent on the female side and the male side even after prolonged transport and storage, and removal of the condom.
The condom is made of one or more of natural rubber latex, polyurethane, polyisoprene, butyl rubber, silicon rubber or graphene.
As another aspect of the invention, the invention also provides a method of packaging a condom system comprising a rolled condom and a container, comprising the steps of:
adding one or more of a lubricant, an anti-HIV agent, an anti-erectile dysfunction agent, an anti-premature ejaculation agent, an anti-infective agent, a hemostatic agent, a libido enhancement agent within the condom and/or the container;
isolating the female side and the male side of the condom; and
sealing the condom in the container;
after sealing, the rolled condom ring and/or mantle is subjected to pressure.
It should be noted that in some cases (e.g., where the separation between the male and female sides of the rolled condom is dependent upon the collar having a diameter greater than the groove height of the rigid box), the step of separating the female and male sides of the condom is accomplished simultaneously with the step of sealing the condom.
Preferably, in the isolating step, the female side and the male side of the condom are isolated from each other by applying pressure between the container and the collar and/or the mantle of the condom; more preferably, the condom ring and/or condom film is subjected to a pressure of 0.196-98 newtons; most preferably, the condom ring and/or condom film is subjected to a pressure of from 0.490 to 49 newtons. The present inventors have found through numerous experiments that by isolating the female and male sides of the condom from each other when the collar and/or the mantle is subjected to a pressure in the above-mentioned range, the mutual migration of the agent between the female and male sides can be effectively reduced, and that the condom system can maintain the "asymmetric" agent and its function with the female and male sides even after a long period of transport and storage, after removal of the condom.
Preferably, in the sealing step, the air pressure inside the container is made lower than the air pressure outside the container by evacuating while the space on at least one side of the container in contact with the rolled condom and its packaging material are compressible. Thus, the collar and the mantle may be squeezed by the container, thereby isolating the female and male sides of the condom to reduce the migration of agents between the female and male sides of the condom.
Preferably, in the sealing step, the container is sealed in a low pressure space so that the pressure inside the container is lower than the pressure outside the container after being placed in a normal pressure environment, in a state where the space on at least one side of the container and the packaging material thereof, which are in contact with the rolled condom, are compressible. Thus, the collar and the mantle may be squeezed by the container, thereby isolating the female and male sides of the condom from each other to reduce migration of agents between the female and male sides of the condom.
It should be noted that the low pressure space is an operable space in which the apparatus to be sealed is placed at a pressure less than the atmospheric pressure of the normal environment, such that when the sealed container is transferred to the normal environment, a pressure differential between the inside and outside of the container is created, causing the collar and the condom membrane to be squeezed directly between the containers, thereby isolating the female and male sides of the condom from each other to reduce the migration of agents between the female and male sides of the condom.
Preferably, the air pressure in the container is 0.002-0.095 MPa less than the air pressure outside the container; most preferably, the pressure inside the container is 0.005 to 0.090 megapascals less than the pressure outside the container. The inventor of the present invention has found through a plurality of experiments that when the pressure difference between the inside and outside of the container is within the above range, the mutual migration of the agent between the female side and the male side of the condom can be effectively reduced, even after the condom is taken out after being transported and stored for a long time, the female side and the male side of the condom are still isolated, and the mutual migration of the agent between the female side and the male side of the condom can be reduced.
In conclusion, the beneficial effects of the invention are as follows:
the present invention provides an improved condom system in which the female and male sides are isolated from each other, which reduces the migration of agents between the female and male sides of the condom, and which maintains the "asymmetrical" agents and their functionality on the female and male sides of the condom over time during transport and storage, removal from the container and use of the condom.
Drawings
Fig. 1 is a schematic view of a rolled condom;
FIG. 2 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 3 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 4 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 5 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 6 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 7 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 8 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
fig. 9 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
fig. 10 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
fig. 11 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 12 is a schematic view of a structure in the container of FIG. 11;
fig. 13 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 14 is a schematic view of a structure in the container of FIG. 13;
FIG. 15 is a schematic cross-sectional view of one embodiment of a condom system of the invention
Fig. 16 is a schematic perspective view of an embodiment of a condom system according to the invention;
FIG. 17 is a schematic cross-sectional view of the container of FIG. 16;
fig. 18 is a schematic perspective view of an embodiment of a condom system according to the invention;
fig. 19 is a schematic cross-sectional view of one embodiment of a condom system of the invention;
FIG. 20 is a schematic view of a structure in the container of FIG. 19;
the sleeve comprises a sleeve body, a sleeve ring, a sleeve membrane female side, a sleeve membrane male side, a sleeve ring upper side, a sleeve ring lower side, a sleeve ring inner side, a sleeve ring outer side, a container, a rigid box body, a cover, a ring 12, an annular groove, a columnar bulge, a protrusion 14, a protrusion 15, a rigid plate, a recess structure 16, a recess 17, a handle, a valley 18, a valley 19, a hook, a bag 20, a soft bag 21 and a plate 1.
Detailed Description
"migration" as used herein means the transfer of an agent that rolls up one side of the condom to the other side of the condom by flowing or squeezing, including from the male side to the female side, from the female side to the male side, and between the two sides, and does not include the transfer and adhesion of agents to the inside of the container and the collar.
The term "migration rate" as used herein means a ratio of an amount of a certain reagent contained in one side that migrates from the other side (referred to as a migration amount of the reagent) to a sum of an amount of the reagent remaining in the other side (referred to as a remaining amount of the reagent) and the migration amount of the reagent when the rolled condom is taken out from a sealed package.
One reagent added to the female side of the condom at the time of packaging is denoted as F and one added to the male side is denoted as M. After transport and storage, the remaining amount of F agent in the female side was recorded as F when the condom was removed from the sealed packageThe residue is leftThe amount of M reagent transferred to the female side was designated as MMigration of(ii) a The remaining amount of M reagent in the male side was recorded as MThe residue is leftThe amount of F reagent transferred to the male side was designated as FMigration of. The calculation formula defining the mobility in the two directions is:
mobility of the M agent from male side to female side: rFor male=mMigration of/(mThe residue is left+mMigration of);
Mobility of the F agent from female side to male side: rWoman=fMigration of/(fThe residue is left+fMigration of)。
This mobility definition reflects the degree of symmetry in the type and amount of reagents on either side of the rolled condom; the closer the mobility of a reagent is to 0, indicating a lower symmetry of the amount of the reagent on both sides, and the closer the mobility of a reagent is to 50%, indicating a higher symmetry of the amount of the reagent on both sides.
When a certain reagent dissolved or dispersed is added into one side of the rolled condom, the residual amount of the reagent and the migration amount to the other side can be obtained by respectively collecting the amount of the reagent on each side, further purifying if necessary, respectively carrying out quantitative analysis (such as various absorption/scattering/excitation-based chromatographic analyses, liquid/gas/mass spectrometry analyses, element analyses, scanning analyses, activity analyses and the like) on the reagent, and finally substituting the residual amount and the migration amount of the reagent on each side into the calculation formula to obtain the corresponding migration rate.
Condoms used in embodiments of the invention:
natural rubber latex condoms produced for industrial processes; the thickness of the covering film is 50 μm, the length is 188mm, the inner diameter and the outer diameter of the rolled covering film in a right circular shape are respectively 30mm and 37mm, and the diameter of the sleeve ring is 3.5 mm; the above values are averages.
To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to the accompanying drawings and specific embodiments.
Example 1
An embodiment of the condom system of the invention is shown in fig. 2, and comprises a rolled condom and a sealed container 9, wherein the rolled condom is arranged in the container 9, the rolled condom comprises a lantern ring 2, a female side 3 and a male side 4 of the condom which are mutually isolated, the container 9 is formed by heat sealing a hard box body 10 which is pressed by PVC material and a cover 11 of an aluminum-plastic composite film, and the lantern ring 2 is connected with the bottom of the hard box body 10 of the container 9 and the cover 11 to form the female side 3 and the male side 4 of the condom which are mutually isolated; the height of the groove of the rigid box 10 is smaller than the diameter of the collar 2 and the rolled condom and/or container is dosed with an agent.
Example 2
In one embodiment of the condom system of the invention, as shown in fig. 3, the container 9 comprises a flexible pouch 20 and a multi-layer structure made of a hard material, the condom is arranged in the flexible pouch 20 and is arranged in each layer of the multi-layer structure, and the upper and lower layer plates 21 of each layer directly or indirectly apply pressure to the collar 2.
Example 3
An embodiment of the condom system of the invention is shown in fig. 4, and comprises a rolled condom and a container 9, wherein the rolled condom is arranged in the container 9, the rolled condom comprises a lantern ring 2, a female side 3 and a male side 4 of the condom which are isolated from each other, reagents are added in the rolled condom and/or the container 9, the container 9 is formed by heat sealing a hard box body 10 formed by pressing PVC materials and a cover 11 of an aluminum-plastic composite film, an annular groove 12 is arranged in the container 9, the width of the annular groove 12 is less than or equal to the diameter +1.5mm of the lantern ring 2, the lantern ring 2 is embedded in the annular groove 12, and the inner side and the outer side of the lantern ring 2 are connected with the side wall of the annular groove 12 in the container to form the female side 3 and the male side 4 of the condom which are isolated from each other.
Wherein, the inner and outer contours of the horizontal section of the annular groove 12 are both circular, and the annular groove 12 is fixedly connected with the container 9.
Example 4
An embodiment of the condom system of the invention is shown in fig. 5, and comprises a rolled condom and a container 9, wherein the rolled condom is arranged in the container 9, the rolled condom comprises a lantern ring 2, a female side 3 and a male side 4 of the condom which are isolated from each other, a reagent is added in the rolled condom and/or the container 9, the container 9 is a soft bag made of aluminum-plastic composite film, the lantern ring 2 and the lantern film are connected with the container 9 due to negative pressure to form the female side 3 and the male side 4 of the condom which are isolated from each other, the air pressure in the container 9 is less than the air pressure outside the container 9, and the air pressure difference between the inside and the outside of the container 9 is 0.045 megapascal.
Example 5
An embodiment of the condom system of the invention, as shown in fig. 6, comprises a rolled condom and a container 9, the rolled condom is arranged in the container 9, the rolled condom comprises a collar 2, a female side 3 and a male side 4 of the condom which are isolated from each other, reagents are added in the rolled condom and/or the container 9, the container 9 is made of a hard box body 10 made of PET (polyethylene terephthalate) material and a cover 11 of an aluminum-plastic composite film by heat sealing, a columnar bulge 13 is arranged in the container 9, the collar 2 is sleeved on the columnar bulge 13, and the collar 2 and the male side of the condom film are connected with the columnar bulge 13 in the container to form the female side 3 and the male side 4 of the condom which are isolated from each other.
Wherein, the minimum outer circumference of the columnar bulge 13 is larger than or equal to the inner circumference of the lantern ring 2, the outer contour of the horizontal section of the columnar bulge 13 is oval, the inner side wall of the columnar bulge 13 is provided with a protrusion 14, and the columnar bulge 13 is fixedly connected with the container 9.
Example 6
An embodiment of the condom system of the invention, shown in fig. 7, comprises a rolled condom and a container 9, the container 9 comprising a rigid box 10 of PS (polystyrene) and an aluminium foil lid 11, the groove height of the rigid box 10 being less than the diameter of the collar 2.
The rolled condom is arranged in a container 9, the internal air pressure of the container 9 is less than the external air pressure of the container 9, and the difference between the internal air pressure and the external air pressure of the container 9 is 0.002-0.095 megapascal; the collar 2 and the mantle are attached to the bottom of the rigid box and the lid 11 to form the female side 3 and male side 4 of the condom, which are isolated from each other.
Example 7
An embodiment of a condom system according to the invention, as shown in fig. 8, comprises a rolled condom and a receptacle 9, the rolled condom being disposed in the receptacle 9, the rolled condom comprising a collar 2, a female side 3 and a male side 4 of the condom being isolated from each other, the receptacle 9 comprising a rigid box 10 and a lid 11 of an aluminium-plastic composite film, the receptacle 9 being provided with an annular groove 12, the rolled condom collar 2 being embedded in the annular groove 12, the collar 2 being connected to the side walls of the annular groove 12 and the lid 11 in the receptacle 9 to form the female side 3 and the male side 4 of the condom being isolated from each other.
Wherein, the height of annular groove 12 is less than the diameter of lantern ring 2, and the width of annular groove 12 is less than or equal to the diameter of lantern ring 2 +1.5mm, and the outer profile of the horizontal cross-section of annular groove 12 is closed decagon, and annular groove 12 and container 9 fixed connection.
Wherein the internal air pressure of the container 9 is less than the external air pressure of the container 9, and the internal and external air pressure difference of the container 9 is 0.002-0.095 megapascal.
Example 8
One embodiment of a method of packaging a condom system of the invention, the condom system comprising a rolled condom and a container, comprises the steps of:
(1) adding one or more of a lubricant, an anti-HIV agent, an anti-erectile dysfunction agent, an anti-premature ejaculation agent, an anti-infective agent, a hemostatic agent, a libido enhancement agent to at least one of the condom and container;
(2) isolating the female side and the male side of the condom; and
(3) and sealing the condom in the container to finish the packaging.
In the step (2), the female side and the male side of the condom are isolated from each other by applying pressure to the lantern ring and/or the mantle membrane of the condom, and the pressure applied to the lantern ring and/or the mantle membrane of the condom is 0.196-98 newtons; and/or the pressure in the container is smaller than the pressure outside the container by vacuumizing, and the pressure difference between the inside and the outside of the container is 0.002-0.095 MPa;
or, the sequence of the step (2) and the step (3) is changed: completing the step (3) in a low-pressure space (lower than the ambient normal air pressure); and (3) after packaging, placing the packaged product in a normal environment, and finishing the step (2), wherein the pressure difference between the inside and the outside of the container is 0.002-0.095 MPa.
Example 9
An example of a method of packaging a condom system of the invention differs from example 8 only in that: the order of steps (1) and (2) was reversed.
Example 10
One example of testing the barrier effect of the condom system of the present invention is shown in fig. 9.
Rolling 440 condoms, S1、R1Two groups of 140 respectively, the rest 160 are divided into S, S2、 R、R2Four groups; 800mg and 160mg of dimethicone were added asymmetrically to each condom on the female 3 and male 4 sides, respectively, with 10mg of benzocaine evenly dispersed in the silicone oil on the male side.
S、S1、S2The three-pack container 9 comprises a rigid sheet 15 of transparent plasticAnd a composite aluminum plastic film. S, S1、S2The upper side and the lower side of the lantern ring of the three groups of condoms are uniformly clamped by transparent plastic hard plates 15 with the diameter of 37mm and the thickness of 1.8mm, the plastic hard plates 15 are tightly attached by composite aluminum-plastic films, and the condoms are sealed by hot pressing. The composite aluminium-plastic film extrudes the plastic hard plate 15 to form pressure on the upper side and the lower side of the lantern ring. R, R1、R2The three groups of condoms are directly heated and sealed by a composite aluminum-plastic film.
And (3) pressure measurement: taking 4 condoms of each group which are packaged and stored for different time as the time point for measuring the mobility, and measuring the average value H of the actual height of the condom ring in the packaged state; taking the same number of unencapsulated condom samples, uniformly clamping the upper side and the lower side of the unencapsulated condom samples by using the same hard plates, and uniformly applying pressure on a press from the upper side and the lower side until the height of the condom lantern ring reaches the corresponding H value of each group, wherein the corresponding pressure reading is the pressure value of the hard plates in the encapsulated samples on the upper side and the lower side of the lantern ring. Determined, S, S1、S2The condom rings in the three groups were subjected to an average pressure of 0.98 + -0.1 Newton, R, R1、R2The corresponding value of three groups is 0 newton; the above measurements did not change significantly with the time of storage.
The placing conditions are as follows: in order to simulate the actual transport and storage conditions of condoms, sealed condom samples are stored in three ways, namely S and R standing, and S1Group R and1group Low speed rotation (2 revolutions per minute), S2Group R and2the groups were rotated at high speed (120 rpm).
And (3) mobility determination: for the samples in the spin group, the samples were allowed to stand for about 15 minutes before sampling. Each group was sampled 4 at a time, the remaining amount and migration amount of benzocaine in the lubricant on both sides of the condom were measured by HPLC, and the migration rate (R) of the lubricant from the male side to the female side of the condom was calculatedFor male) Average value of (a). The results are summarized in Table 1 a.
TABLE 1a various groups R at different time pointsFor male
Figure RE-GDA0002043769230000171
Figure RE-GDA0002043769230000181
The results show that after the upper and lower sides of the rolled condom ring are sealed with a hard plate and then with a soft container, the upper and lower sides of the ring can be pressurized and the migration rate (R) of benzocaine from the male side to the female side of the condom under different rotation conditions can be achieved (R)For male) Substantially zero, maintaining the "asymmetry" of the lubricant on both sides of the rolled condom; the migration rate (R) of benzocaine under the same conditions by directly using a condom packaged by a soft bag and without pressureFor male) It is significantly faster, with further speeds after the spin is applied, and eventually the two-sided lubricant will tend to be substantially symmetrical.
S stored for more than 8 weeks according to the above conditions1、R1100 condoms each of the two groups were tested for use experience by 50 male volunteers. Two S are respectively randomly used by each volunteer1Sample and two R1And (5) filling the use effect by the experiencer according to the questionnaire. The main results are summarized in table 1b below.
TABLE 1b comparison of volunteer trial experience
Figure RE-GDA0002043769230000182
The results show that S decreases sexual sensitivity in women due to the migration of benzocaine into the female side in three main indicators of the experience of the volunteer (wrinkling of the mantle, upward lifting of the condom due to downward slippage, and reduced sexual sensitivity of the woman)1The group is obviously superior to R1And (4) grouping.
Example 11
One example of testing the barrier effect of the condom system of the present invention is shown in fig. 10.
The container 9 is provided with two curved hard plates 15 which are fixedly connected with the container into a whole, and the container and the curved hard plates are made of polypropylene (PP) materials. The condom is placed in a container 9, reagent is added in the container, and the female side 3 and the male side 4 of the condom film are respectively pressed by the two hard plates from the upper side and the lower side to form the female side and the male side 4 of the condom and the lantern ring 2 which are mutually isolated.
50 rolled condoms were divided equally into two groups S and R, each with 0.8ml of water soluble lubricant and 90mg of policresulen added to the female side. In group S, the condoms were placed in the containers and heat-sealed. The R group of condoms are packaged in a conventional condom packaging box and are heat-sealed by a composite aluminum plastic film. Both groups of sealed condoms were stored in low speed rotation (2 rpm).
The analysis method comprises the following steps: at different time points, respectively taking 5 condoms from each group, respectively drawing reagents on each side and combining; the content of the policresulen was measured by HPLC.
Calculating the migration rate (R) of policresulen from female side to male side according to the residual amount and migration amount of policresulen on both sides of the collarWoman) The results are summarized in Table 2.
TABLE 2 groups R at different time pointsWoman
Figure RE-GDA0002043769230000191
The results showed that the migration rate of policresulen (R) from female side to male side under the above-mentioned rotation conditions, in which the rolled condom film in the S group was isolated after the rolled condom film was pressed on both sides by the hard sheet, and the condom films on both sides of the rolled condom were isolatedWoman) Remain at zero at different times; in contrast, in the group R condoms sealed in a common rigid case, the migration rate of policresulen (R) from the female side to the male side is not the result of the barrier effectWoman) The increase is rapid and the symmetry is quickly approached on both sides.
Example 12
One example of testing the barrier effect of the condom system of the present invention is shown in fig. 11 and 12.
Equally dividing 325 rolled condoms into S1~S12Groups, R, each added 600mg of dimethicone to the female side 3 of the condom. The R group is used as a contrast, and is directly sealed by a soft composite aluminum-plastic film and then is rotated. At S1~S12A round hollow hard plate 15 is arranged on the inner side 7 of the lantern ring 2 of each condom in each group, the outer diameter of the hard plate is 30mm, and the thickness of the hard plate is 3 mm; then, soft composite aluminum-plastic films are used on two sides of each condom, and the condoms are heated and sealed after being vacuumized to different negative pressures by a vacuum plastic packaging machine with a pressure gauge. The negative pressure in the sealed package is directly displayed on the pressure gauge. Each group was stored under conditions of 40 ℃ temperature and high-speed rotation (120 rpm), and the remaining amount and the transferred amount of the lubricant on each side were sampled at different times to calculate the mobility (R)Woman). The results are given in Table 3 below.
TABLE 3 mobility (R) for each group at different time pointsWoman) Variations of (2)
Figure RE-GDA0002043769230000201
The results show that when negative pressure is present in the sealed pouch, a certain "asymmetry" of the lubricant on both sides of the condom can be maintained during storage and rotation; when the sealed soft bag is vacuumized until the negative pressure is 0.002-0.095 MPa, effective isolation can be formed between two sides of the condom, the round hollow hard plate on the inner side of the lantern ring limits the lantern ring to move in the sealed package and better keeps the isolation effect, and at the moment, the mobility of the lubricant is still low when the condom rotates at a high speed for 8 weeks, so that the asymmetry of the lubricant is better maintained; when the vacuum pressure inside the sealed package is above 0.095 megapascals, too high a pressure causes a portion of the lubricant to squeeze out of the female side 3 of the sleeve.
Example 13
One example of testing the barrier effect of the condom system of the present invention is shown in fig. 13 and 14.
As shown in fig. 13, the container 9 is a soft bag made of a composite aluminum-plastic film, a columnar protrusion 13 is arranged in the soft bag, as shown in fig. 14, the columnar protrusion is a cylinder (with an outer circumference of 104mm and a height of 4.5mm), a segment-shaped concave structure 16 (with a volume of 0.42ml) is arranged in the middle of the columnar protrusion, 4 protrusions 14 (for preventing a condom ring from falling off) are arranged at the top of the side wall of the columnar protrusion, and 2 handles 17 are arranged at the bottom of the side wall of the columnar protrusion, so that the condom can be taken and used conveniently.
The 240 rolled condoms were equally divided into S, S1、S2、R、R1、R2Six groups, 0.8ml of water-based lubricant and 40mg of metronidazole were added to the female side of each condom, and 0.25ml of the same water-based lubricant and 5mg of lidocaine hydrochloride were added to the male side of each condom.
At S, S1、S2In three groups, the condom ring 2 is sleeved outside the columnar bulges, and then the columnar bulges 13 are placed in the soft bag for heat sealing. R, R1、R2Three groups are used as control, and the composite aluminum plastic film is directly used for heating and sealing.
Method for determining the pressure exerted on the inside of a condom ring: measuring the median circumference C (namely the average value of the inner circumference and the outer circumference of the lantern ring) of the lantern ring sleeved on the columnar bulge; corresponding to the C value of each group, taking 10 condoms, and dividing the corresponding tension value by 2 to obtain the pressure value on the inner side of the condom ring when the condom ring is pulled on a tension machine until the circumference of the middle position of the condom ring is equal to C.
The pressure measurement value of the inner side of each group of condom ring is as follows: s, S1、S2Three groups are 4.9 + -0.5 Newton, R, R1、R2Three groups are 0 newtons; these pressure values did not vary significantly depending on the storage time and conditions of the sealed condom.
Storage conditions were as follows: for analog transportation and storage, S, S is added1、S2、R、R1、R2The six groups were placed under different conditions as in example 10.
And (3) mobility determination: at different time points, respectively taking 4 condoms from each group, respectively drawing reagents on each side and combining; and (3) respectively measuring the content of each reagent by using HPLC (high performance liquid chromatography), so as to obtain the residual amount and the migration amount of the lidocaine hydrochloride and the metronidazole on the male side and the female side respectively, and calculating the migration rate of the reagents.
The mobility results are shown in table 4 below. Wherein R isFor maleIs the mobility of the reagent lidocaine hydrochloride from the male side to the female side, RWomanIs the mobility of the agent metronidazole from the female side to the male side.
TABLE 4 mobility (R) of drugs in each group at different time pointsFor maleAnd RWoman)
Figure RE-GDA0002043769230000221
The results show that the mobility of the two agents between the two sides of the rolled condom, directly enclosed in a soft pouch, is already close to 50% at weeks 4-8 (i.e. symmetrical); while in the sample rolled up inside the condom collar, nested in the above cylindrical protrusion and then resealed, the reagents added on either side of the collar did not migrate, whether at rest or under different rotation conditions, remaining with the asymmetry that the two reagents formed when added.
Example 14
One example of testing the barrier effect of the condom system of the present invention is shown in fig. 15.
The container 9 is provided with a cylindrical projection 13 having a diameter of 25mm and a height of 5.0mm, and a segment-shaped recess 16 (recess volume of 0.7ml) is provided in the middle portion of the cylindrical projection.
50 rolled condoms were divided equally into two S and R groups, each with 0.5ml of water-based lubricant and 50mg of tranexamic acid added to female side 3. In group S, the columnar bulges are placed on the inner side 5 of the condom lantern ring and are sealed by a composite aluminum plastic film through hot pressing. The composite aluminum-plastic film and the columnar protrusions clamp the closed end and apply pressure to the closed end sleeve film, and reagents on the closed end and the female side are contained in the spherical segment-shaped depressions. The R group condoms are directly heat sealed by a composite aluminum plastic film. Both groups of sealed condoms were stored in low speed rotation (2 rpm).
The analysis method comprises the following steps: at different time points, 5 condoms from each group were withdrawn separately from each side and the reagents were combined and subjected to HPLC for tranexamic acid content.
Calculating the migration rate (R) of tranexamic acid from the female side to the male side of the condom based on the remaining amount and migration amount of tranexamic acid on each side of the condomWoman) The results are summarized in Table 5.
TABLE 5 groups R at different time pointsWoman
Figure RE-GDA0002043769230000231
The results show that the migration rate (R) of tranexamic acid from the female side to the male side under low speed rotation conditions after the above-described columnar protruding structure was added to the package and only the condom film was pressedWoman) Remain at zero at different times; while for condoms sealed in flexible bags, the migration rate (R) of tranexamic acid from the female side to the male sideWoman) The increase is rapid and the symmetry is quickly approached on both sides.
Example 15
One example of testing the barrier effect of the condom system of the present invention is shown in fig. 16 and 17.
An annular groove 12 is arranged in the container 9, the height of the annular groove is 4.0mm, the maximum width of the top of the annular groove is 3.8mm, the diameter of the circular arc bottom of the annular groove is 3.3mm, the inner wall of the annular groove extends upwards to form a columnar bulge 13 (the outer circumference is 95.8mm), the middle part of the columnar bulge is provided with a segment-shaped recess 16 (the recess volume is 0.42ml), the inner wall of the annular groove is provided with three protrusions 14 (the maximum point of the protrusion is 0.6mm), one part of the annular groove extends outwards to form a valley 18 of an inclined plane (so that a finger can take out the condom along the valley), and the bottom of the valley is 1.5mm lower than the bottom of the annular groove.
Divide 120 rolled condoms equally into S, S1、S2、R、R1、R2Six groups, each with 800mg of dimethicone added to the female side. S, S1, S2 three groups of condom collars are placed in the annular groove of the hard box body and are sealed by aluminum plastic film through hot pressing. R, R1、R2The three groups of condoms are directly heated and sealed by a composite aluminum-plastic film.
The placing conditions are as follows: s group and R group standing storage, S1Group R and1the groups were stored in low speed rotation (2 rev/min), the S2 groups and the R2 groups were stored in high speed rotation (120 rev/min).
The determination method comprises the following steps: the remaining amount and the migration amount of the lubricant on both sides were measured in 4 of the respective samples at different time points, and the migration rate (R) of the dimethylsilicone oil from the female side to the male side was calculatedWoman). The results are summarized in Table 6.
TABLE 6 groups R at different time pointsWoman
Figure RE-GDA0002043769230000241
The results show the dimethicone migration rate (R) from the female side to the male side at various times and rotations after the rolled condom collar is inserted into the groove structureWoman) Keeping low, highly preserving the "asymmetry" of the lubricant on both sides of the rolled condom; the condom directly sealed in the soft bag has obviously faster mobility of the simethicone under the same time and condition, wherein the mobility of the simethicone is further accelerated after the rotation is applied, and finally, the lubricants on two sides are basically symmetrical.
Example 16
The condom system of this example was identical to that of example 15 except for the following: one part of the annular groove 12 is provided with a shallow groove-shaped valley 18 (the depth is 0.5mm, and the width is 5mm) with uniform depth and uniform width from the bottom of the circular arc; a hook 19 of the same shape can be placed in the shallow groove-like valleys 18, and after the hook 19 is placed, the whole structure forms a complete annular groove (see fig. 18).
Using the same experimental protocol and method as in example 15, the mobility (R) of dimethicone from the female side to the male side was obtainedWoman). The results are summarized in Table 7.
TABLE 7 groups R at different time pointsWoman
Figure RE-GDA0002043769230000251
The results show that after the rolled condom ring is embedded into the groove structure, the asymmetry of the dimethyl silicon oil on the two sides of the rolled condom is highly maintained under different time and rotation conditions; the simethicone on the two sides of the condom directly sealed in the soft bag tends to be symmetrical quickly.
Example 17
One embodiment of a condom system of the invention is shown in Figs. 19 and 20. The container is internally provided with an inner layer of columnar bulges 13 and an outer layer of columnar bulges 13, wherein the columnar bulges on the inner layer are uniformly arranged by 8 cylinders with the diameter of 6.0mm according to a regular octagon, and the columnar bulges on the outer layer are uniformly arranged by 8 cylinders with the diameter of 8mm according to the regular octagon, so that the minimum clearance between each outer side cylinder and two adjacent inner side cylinders is equal.
The condom products provided by the embodiments 1-17 of the invention are tested according to ISO4074-2015, and the results are all qualified.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that the technical solutions of the present invention can be combined, modified or equivalent replaced without departing from the spirit and scope of the technical solutions of the present invention.

Claims (14)

1. A condom assembly comprising a rolled condom and a container within which the rolled condom is disposed, the rolled condom comprising a collar, a condom membrane female side and a male side which are isolated from one another; pressure exists between the lantern ring and/or the mantle and the container;
the container comprises a hard box body and a cover which are made of hard materials, wherein a columnar bulge is arranged in the hard box body, the columnar bulge is provided with a top surface and a side wall, and the hard box body is also provided with an edge part; the edge part is provided with an edge upper top surface, and the top surface and the edge upper top surface are positioned on the same plane;
the lantern ring is sleeved on the columnar bulge, the outer circumference of the columnar bulge is larger than or equal to the inner circumference of the lantern ring,
the container comprises an annular groove, the lantern ring is embedded into the annular groove, one part of the annular groove extends outwards to form a valley of the inclined plane, and the bottom of the valley is lower than that of the annular groove.
2. The condom assembly of claim 1, wherein the rolled condom and/or container has an agent added thereto, the agent being of a different kind and/or amount on the female and male sides of the condom.
3. The condom assembly of claim 1, wherein the side wall of the stud bump is provided with at least one protrusion or indentation.
4. The condom assembly of claim 1, wherein the columnar protrusions have a concave structure in the middle.
5. The condom assembly of claim 4, wherein the width of the annular groove is less than or equal to +1.5mm of the diameter of the collar.
6. A condom assembly comprising a rolled condom and a container within which the rolled condom is disposed, the rolled condom comprising a collar, a condom membrane female side and a male side which are isolated from one another; pressure exists between the lantern ring and/or the mantle and the container;
the container comprises a hard box body made of hard materials, the hard box body comprises a first hard plate and a second hard plate, the first hard plate and the second hard plate are both provided with hollow structures, and the lantern ring is placed in the hollow structures;
the middle part of the first hard board protrudes to the female side of the mantle, so as to form a first hard board protrusion, the middle part of the second hard board protrudes to the male side of the mantle, so as to form a second hard board protrusion, and the first hard board protrusion and the second hard board protrusion form a containing space for containing part of the mantle of the closed end of the condom; the first and second hard plates further having planar extensions, the planar extensions of the first hard plate and the planar extensions of the second hard plate surrounding the first and second hard plate protrusions, respectively; the planar extension of the first rigid plate is in contact with the female side of the condom; the male side of the condom membrane is in contact with the planar extension of the second rigid panel.
7. The condom assembly of any one of claims 1-6, wherein the pressure is between 0.196-98 newtons.
8. The condom assembly of any one of claims 1-6 wherein the pressure of the gas inside the container is less than the pressure of the gas outside the container.
9. The condom assembly of claim 8 wherein the gas pressure inside the container is 0.002-0.095 megapascals less than the gas pressure outside the container.
10. The condom assembly of claim 8 wherein the gas pressure inside the container is 0.005 to 0.090 megapascals less than the gas pressure outside the container.
11. A method of packaging a condom assembly including a rolled condom and a container according to any one of claims 1 to 10, including the steps of:
adding one or more of a lubricant, a dissolved or dispersed anti-HIV agent, an anti-erectile dysfunction agent, an anti-premature ejaculation agent, an anti-infective agent, a hemostatic agent, a libido enhancement agent within the condom and/or the container;
isolating the female side and the male side of the condom and sealing the condom within a container;
wherein pressure is applied between the collar and/or the mantle of the condom and the container by an isolation step and a sealing step;
the condom ring and/or condom membrane is subjected to a pressure of from 0.196 to 98 newtons.
12. The method of packaging of claim 11, wherein the condom ring and/or condom film is subjected to a pressure of from 0.490 to 49 newtons.
13. The method of claim 11, wherein the sealing step is performed by evacuating the container so that a pressure of the gas in the container is 0.002 to 0.095 mpa less than a pressure of the gas outside the container.
14. The method of claim 11, wherein the sealing step is performed by evacuating the container so that the pressure inside the container is less than the pressure outside the container by 0.005 to 0.090 megapascals.
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CN110251737A (en) * 2019-08-06 2019-09-20 湖南优感觉生物科技有限公司 A kind of latex prophylactic being added to sodium hyaluronate

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