CA2318121A1 - Method of manufacturing a disposable cervical cap - Google Patents
Method of manufacturing a disposable cervical cap Download PDFInfo
- Publication number
- CA2318121A1 CA2318121A1 CA002318121A CA2318121A CA2318121A1 CA 2318121 A1 CA2318121 A1 CA 2318121A1 CA 002318121 A CA002318121 A CA 002318121A CA 2318121 A CA2318121 A CA 2318121A CA 2318121 A1 CA2318121 A1 CA 2318121A1
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- Prior art keywords
- cap
- dome
- cervical
- top portion
- cervical cap
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
- A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2083/00—Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
- B29K2083/005—LSR, i.e. liquid silicone rubbers, or derivatives thereof
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Reproductive Health (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Mechanical Engineering (AREA)
- Injection Moulding Of Plastics Or The Like (AREA)
- Prostheses (AREA)
Abstract
The present invention relates to an improved method of manufacturing a disposable cervical cap by injection molding and cervical caps produced thereby. The method includes providing an injection point at a top portion location of a heated mold cavity and injecting an elastomeric molding material into the heated mold cavity at the injection point. The material flows downwardly throughout the mold cavity, producing a molded cap (10) having a substantially thickened annular rim (18) and a form-assuming dome (12) with a generally thickened top portion (20) having an interior and exterior surface and a substantially thin middle portion (22).
Description
i . CA 02318121 2000-07-14 6 ~UL 1999 METHOD OF MANUFACTURING A DISPOSABLE CERVICAL CAP
Background of the Invention 1. Field of the Invention The present invention relates generally to a method of manufacturing a disposable cervical cap and a cervical cap produced thereby, and, more particularly, to a method of molding a cervical cap according to a generally thick to substantially thin to a substantiai~y hick system.
Background of the Invention 1. Field of the Invention The present invention relates generally to a method of manufacturing a disposable cervical cap and a cervical cap produced thereby, and, more particularly, to a method of molding a cervical cap according to a generally thick to substantially thin to a substantiai~y hick system.
2. Discussion of the Related Art Cervical caps composed of silicone rubber are typically molded by a traditional thick to thin hot runner system. This system includes injecting molding material into a bottom section of the mold~,ig cavity, forming a molded part having a thickened bottom portion and thin top portion. The product, however, typically has a seam where the streams of flowing molded material meet in the mold cavity, resulting in a molded part having a particularly weak area.
Additionally, this thick to thin system wastes up to about 23% of the molding material as a result of long inlet pipes or runs in which the material must travel to reach the mold. Thus, because of the nature of the material, the silicone material in the- runners cannot be reused.
The present invention provides an improved method of manufacturing disposable cervical caps which overcomes the aforementioned problems. The method o; the present invention reduces the excess waste of mold;og material and produces a molded product with minimal stress seams.
Sumrnaryi of the Invention The present invention relates to an improved method of manufacturing a disposable cervical cap by injection molding. The method includes providing an injection point at a top portion location ~f a heated mold cavity and injecting an elastomeric molding material into the heated mold cavity at the injection point.
The material then flows downwardly throughout the mold cavity, producing a molded cap having a substantially thickened annular rim and a form-assuming QED SHED' .'~'~~ 9 g / 0 ~. ~ 6 ~
~S ~ 6 ,!UL 1999 dome with a generally thickened top portion having an interior and exterior surface and a substantially thin middle portion. The method further includes the step of removing the moldea cap from the rr,nld cavity.
The present invention also provides an improved disposable cervical cap comprising a thin, form-assuming flexible dome having an interior and exterior surface. The dome comprises a top portion having first and second sections and a base portion. The first section of the top portion of the dome is about 0.35 millimeters thick and the second section of the top portion is about 0.25 millimeters thick. The cap also includes a flexible, annular rim integrally-molded 1 a with the base portion of the dome, where the rim has an inner and outer surface.
Additional advantages and features of the present invention will become apparent from the subsequent description and the appended claims, taken in conjunction with the accompanying drawings.
Brief Description of the Drawings FIG. 1 is a side view of a preferred embodiment of a cervical cap of the present invention;
FIG. 2 is a top elevational view of the cervical cap;
FIG. 3 is a sectional view, taken along line 3-3 in FIG. 2;
FIG. 4 is a side view of an alternate preferred embodiment cervical cap of the present invention; and FIG. 5 is a sectional view, taken along line 5-5 i~ FIG. 4.
Detailed Description of the Preferred Embodiment Generally thick to substantially thin to substantially thick injection molding at a top portion location of a mold cavity is an improved method in which to mold silicone rubber. Pather than injecting the silicone material into the bottom portion of the mold cavity or in :;~e rim portion of the mold, the present invention provides a step of injecting elastomeric molding material, such as silicone rubber, at a top portion location of a heated mold cavity. The method produces a molded cap having a form-assuming dome with a generally thickened top portion having interior and exterior surfaces and a substantially thin middle AMENDED SHEET
»:AlltlS 2 s ~ a ~ ~9 ~ 9' portion. The method produces a more cost efficient and effective cervical cap that includes a generally thickened uppermost top section and a substantially thinner middle section comprising the remaining portion of the dome. The thickened uppermost portion of the apex of the dome is preferably about 0.35 ~
0.03 millimeters, while the remaining top portion of the dome is preferably about 0.25 millimeters, and most preferably abet 0.22 ~ 0.03 millimeters of silicon.
The molded cap also includes a substantially thickened annular rim.
By employing a thick to thin to thick sys~em where elastomeric molding material is injected at a top portion location of a heated mold cavity producing a dome having a thickened top portion, the present invention utilizes substantially less molding material than traditional molding processes and results in a molded cervical cap with minimal seams. In addition, the use of a thickened top portion on the dome facilitates the removal of excess molding material at the injection point without damaging the dome integrity.
The excess waste associated with injecting molding material at the bottom of the mold cavity or rim portion of the cervical cap is a result of the long inlet pipes or runs in which the material must travel to reach the mold.
In a preferred embodiment of the present invention, the method further comprises a step of creating a reservoir at the top portion location for storing molding material as it is injected into the top portion location of the molding cavity. The reservoir allows the injected molding material to pool and remain wa.~,-n, building up the pressure necessary to cause the material to flow throug;~out the cavity before tha material hardens. The reservoir is preferably formed by thickening the interior surface of the top portion of the molded cap.
Alternatively, the reservoir is formed by thickening the exterior surface of the top portion.
The cervical cap produced by the method of manufacturing of the present invention preferably is a thin-walled, flexible, and pliant dome with an integrally-molded flexible retaining rim. In position, the flexible dome of the cervical cap conforms to the exocervical surface to closely fit the cervix upon contact.
Due to its thinness and pliability, the dome of the cap will continue to adhere to the AMENOtro SHEET
6 ~UL 1999 surface of the cervix until removed. Adherence to the dome of the cervix is further facilitated by the moist cervical surface.
The cervical cap produced by the process of the present invention may be employed as a contraceptive, or alternatively, as a conception device, depending on the desired result. The coy ~' ~ceptive device functions to prevent semen from entering the ;,ervicai canal (Os), while the conception device aids in fertilization when sperm is placed inside the cap and the device is placed over the cervix, thereby concentrating sperm at the opening of the Os.
Referring to FIG. 1, a areferred embodiment of a cervical cap of the present invention is illustrated and indicated generally by the numeral 10.
Generally speaking, cervical cap 10 comprises a flexible, thin, form-assuming dome 12, a top portion 14, a base portion 16, and an annular rim 18.
Dome 12 is generally thimble-shaped, with base portion 16 inwardly tapering toward top portion 14. The outer diameter of rim 18 is greater than that of base portion 16 of dome 12.
Dome 12 further includes a thickened first section 20 and a second section 22. First section 20 is an inactive or non-functional area of the dome, while second section 22 is an active area that most effectively functions as the gripping portion of the dome to the cervix. The second section is preferably less than about one-third of a millimeter, most preferably less than about 0.25 of a millimeter, and still more preferably about 0.22 millimeters thick. The thickened first secticn is preferably about 0.35 millimeters thick.
In an alternate preferred ~-nbodiment, the cervical cap 10 further includes a loop 28 that serves as a handle, iacilitatE~ insertion and removal of cap 10, and is integrally-molded with annular rim 18.
In an additional preferred embodiment, referring particularly to FIGS. 2 and 3, annular rim 18 has an inner surface 24 and an outer surface 26. Thin, gripping finger 30 projects radially inwardly, as finger 30 is integrally-formed with inner surface 24. Finger 30 also defines an upper portion of a notched indentation 32 as viewed in FIG. 3. Annular rim 18 contains at least two gripping fingers 30 that are directly opposite or symmetrically opposed from each other QED St~tEE~' ca o23isi2i Zooo-o~-i4 ~~~V~ 7 n ~ U 1- i C~ ~
1l~A~l~IS
along inner surface 24. However, it will be appreciated to one skilled in the art that more than two fingers could be employed.
Fingers 30 have at least one notch 25 to parmit the fingers to bend towards crown section 14 of dome 12 during insertion of the cap. Fingers 30 5 and notches 25 effectively grip and hold cervical cap 10 over the cervix in order to prevent semen from enterir,~ the cervical canal or to aid in fertilization, depending on the desired result. Gripping fingers 30 and notches 25 essentially provide the effect of a Chinese finger puzzle by gripping the side walls of the cervix and holding the cap when the circumference of the rim 18 is fitted around the cervix and slightly expands. Cervical cap 10 is fixed in place by the use of gripping fingers 30 rather than merely by suction or surface viscosity.
Referring now to FIGS. 4 and 5, an alternate embodiment of the present invention provides a cervical cap 110 comprising a flexible, thin, form-assuming dome 112, an apex portion 114, a base portion 116, and an annular rim 118.
Dome 112 is generally thimble-shaped, with base portion 116 inwardly tapering toward apex portion 114. The outer diameter of rim 118 is greater than that of base portion 116 of dome 112.
Dome 112 further includes a thickened first section 120 and a second section 122. First section 120 is an inactive or non-functional area of the dome, while second section 122 is an active area that most effectively functions as the gripping portion of the dome to the cervix. The second section is preferably less than about one-third of a millimeter, most preferably less than about 0.25 of a millimeter, and still more preferably about 0.22 millimeters thick. The thickened first section is preferahw about 0.35 millimeters thick.
REferring particularly to FIG. 5, rim 118 has an inner surface 124 and an outer surface 126, bottom surface 128, and upper surfaces 130 and 132. Upper surface 130 extends leftward from base portion 116, as viewed in FIG. 5, and terminates at outer shoulder 134. Upper surface 132 extends rightward from base portion 116, as viewed in FIG. 5, and terminates at outer shoulder 136.
Upper surface 132 extends at an acute angle from adjacent base portion 116, preferably, for example, at about an 85 degree angle.
~TfDED SHEET
U2318121 2UUU-~~-14 ~~s 98 ~ o z z b I~~:AI~ ~ 6 J U L ~ 9 ~ 9 Annular rim 1 .8 has generally inwardly direc:ed annular groove 138. The side walls or annular groove 138 extend generally toward bottom surface 128 with the opening of annular groove 138 facing inwardly and upwardly as shown in FIG. 5. Adjacent to annular groove 138 are annular upper rim 140 and annular lower rim lip 142. As illustrated in FIG. 5, both ~pper rim lip 140 and lower rim lip 142 extend generally inwardly and upwardly at an angle acute to dome base portion 116. This lip configuration serves to grip the cervix wall and helps keep the cervical cap in position over the cervix as an alternate embodiment to the configuration shown in FIGS. 2 and 3.
In a further preferred embodiment, cervical cap 110 includes a loop 144 that serves as a handle, facilitates insertion and removal of cap 110, and is integrally-molded with annular rim 118.
It is preferred that the cervical cap of the present invention be constructed of a sperm-impermeable, tear-resistant medical elastomer, such as a silicone rubber, and formed by liquid injection molding. Other suitable materials, such as RTV thermoplastic that can be molded thin enough to be form-conforming and pliant may also be employed.
Preferred materials include a 40 durometer silicone, such as Silastic Q4840 (Dow Corning) or Silicone 4040 (Bayer). When thinly molded, these materials allow for up to a 600% stretch of the molded product.
The elastomer material may or may not be impregnated with biologically active components. These components may include, but are not limited to, spermicides, antibiotics, antifungan and hom-:m ~al replacements. For example, to increase its contraceptive effect, ;~ne cervical cap of the present invention may be pre-treated by coating or impregnating its surface with spermicidal agents during manufacture.
The biologically active components may also assist in fertilization, or may be mixed with sperm within the hollow body of the dome of thA cap in order to achieve the desired result. The use of biologically active materials may stimulate sperm motility, prolong the active life of the sperm or aid in gender selection.
Selectively eliminating or altering the behavior of some sperm by significantly changing the pH may bias the activity of the X or Y sperm, resulting in odds r ~IENDEO ~'-'~-~ ~
.~. ..__ ca o23isi2i Zooo-o~-i4 / U ~. / f?'+
~~~~~ y ~ ~ ~ ~ n 1499 which favor one particular sex over the other. These components may be released therefrom in an amount effective to achieve its purpose during use.
Although the description as set forth is in conjunction with human subjects, it will be further appreciated that the claimed products and methods may ' a readily adaptable for use with animal subjects having : cervix.
While it will be apparent thai the preferred embodiments disclosed are well calculated to provide the advantages and features above stated, it will be appreciated that the invention is susceptible to modification, variation, and change without departing from the proper sc~~e or fair meaning of the subjoined claims.
AMENDED SNEET
Additionally, this thick to thin system wastes up to about 23% of the molding material as a result of long inlet pipes or runs in which the material must travel to reach the mold. Thus, because of the nature of the material, the silicone material in the- runners cannot be reused.
The present invention provides an improved method of manufacturing disposable cervical caps which overcomes the aforementioned problems. The method o; the present invention reduces the excess waste of mold;og material and produces a molded product with minimal stress seams.
Sumrnaryi of the Invention The present invention relates to an improved method of manufacturing a disposable cervical cap by injection molding. The method includes providing an injection point at a top portion location ~f a heated mold cavity and injecting an elastomeric molding material into the heated mold cavity at the injection point.
The material then flows downwardly throughout the mold cavity, producing a molded cap having a substantially thickened annular rim and a form-assuming QED SHED' .'~'~~ 9 g / 0 ~. ~ 6 ~
~S ~ 6 ,!UL 1999 dome with a generally thickened top portion having an interior and exterior surface and a substantially thin middle portion. The method further includes the step of removing the moldea cap from the rr,nld cavity.
The present invention also provides an improved disposable cervical cap comprising a thin, form-assuming flexible dome having an interior and exterior surface. The dome comprises a top portion having first and second sections and a base portion. The first section of the top portion of the dome is about 0.35 millimeters thick and the second section of the top portion is about 0.25 millimeters thick. The cap also includes a flexible, annular rim integrally-molded 1 a with the base portion of the dome, where the rim has an inner and outer surface.
Additional advantages and features of the present invention will become apparent from the subsequent description and the appended claims, taken in conjunction with the accompanying drawings.
Brief Description of the Drawings FIG. 1 is a side view of a preferred embodiment of a cervical cap of the present invention;
FIG. 2 is a top elevational view of the cervical cap;
FIG. 3 is a sectional view, taken along line 3-3 in FIG. 2;
FIG. 4 is a side view of an alternate preferred embodiment cervical cap of the present invention; and FIG. 5 is a sectional view, taken along line 5-5 i~ FIG. 4.
Detailed Description of the Preferred Embodiment Generally thick to substantially thin to substantially thick injection molding at a top portion location of a mold cavity is an improved method in which to mold silicone rubber. Pather than injecting the silicone material into the bottom portion of the mold cavity or in :;~e rim portion of the mold, the present invention provides a step of injecting elastomeric molding material, such as silicone rubber, at a top portion location of a heated mold cavity. The method produces a molded cap having a form-assuming dome with a generally thickened top portion having interior and exterior surfaces and a substantially thin middle AMENDED SHEET
»:AlltlS 2 s ~ a ~ ~9 ~ 9' portion. The method produces a more cost efficient and effective cervical cap that includes a generally thickened uppermost top section and a substantially thinner middle section comprising the remaining portion of the dome. The thickened uppermost portion of the apex of the dome is preferably about 0.35 ~
0.03 millimeters, while the remaining top portion of the dome is preferably about 0.25 millimeters, and most preferably abet 0.22 ~ 0.03 millimeters of silicon.
The molded cap also includes a substantially thickened annular rim.
By employing a thick to thin to thick sys~em where elastomeric molding material is injected at a top portion location of a heated mold cavity producing a dome having a thickened top portion, the present invention utilizes substantially less molding material than traditional molding processes and results in a molded cervical cap with minimal seams. In addition, the use of a thickened top portion on the dome facilitates the removal of excess molding material at the injection point without damaging the dome integrity.
The excess waste associated with injecting molding material at the bottom of the mold cavity or rim portion of the cervical cap is a result of the long inlet pipes or runs in which the material must travel to reach the mold.
In a preferred embodiment of the present invention, the method further comprises a step of creating a reservoir at the top portion location for storing molding material as it is injected into the top portion location of the molding cavity. The reservoir allows the injected molding material to pool and remain wa.~,-n, building up the pressure necessary to cause the material to flow throug;~out the cavity before tha material hardens. The reservoir is preferably formed by thickening the interior surface of the top portion of the molded cap.
Alternatively, the reservoir is formed by thickening the exterior surface of the top portion.
The cervical cap produced by the method of manufacturing of the present invention preferably is a thin-walled, flexible, and pliant dome with an integrally-molded flexible retaining rim. In position, the flexible dome of the cervical cap conforms to the exocervical surface to closely fit the cervix upon contact.
Due to its thinness and pliability, the dome of the cap will continue to adhere to the AMENOtro SHEET
6 ~UL 1999 surface of the cervix until removed. Adherence to the dome of the cervix is further facilitated by the moist cervical surface.
The cervical cap produced by the process of the present invention may be employed as a contraceptive, or alternatively, as a conception device, depending on the desired result. The coy ~' ~ceptive device functions to prevent semen from entering the ;,ervicai canal (Os), while the conception device aids in fertilization when sperm is placed inside the cap and the device is placed over the cervix, thereby concentrating sperm at the opening of the Os.
Referring to FIG. 1, a areferred embodiment of a cervical cap of the present invention is illustrated and indicated generally by the numeral 10.
Generally speaking, cervical cap 10 comprises a flexible, thin, form-assuming dome 12, a top portion 14, a base portion 16, and an annular rim 18.
Dome 12 is generally thimble-shaped, with base portion 16 inwardly tapering toward top portion 14. The outer diameter of rim 18 is greater than that of base portion 16 of dome 12.
Dome 12 further includes a thickened first section 20 and a second section 22. First section 20 is an inactive or non-functional area of the dome, while second section 22 is an active area that most effectively functions as the gripping portion of the dome to the cervix. The second section is preferably less than about one-third of a millimeter, most preferably less than about 0.25 of a millimeter, and still more preferably about 0.22 millimeters thick. The thickened first secticn is preferably about 0.35 millimeters thick.
In an alternate preferred ~-nbodiment, the cervical cap 10 further includes a loop 28 that serves as a handle, iacilitatE~ insertion and removal of cap 10, and is integrally-molded with annular rim 18.
In an additional preferred embodiment, referring particularly to FIGS. 2 and 3, annular rim 18 has an inner surface 24 and an outer surface 26. Thin, gripping finger 30 projects radially inwardly, as finger 30 is integrally-formed with inner surface 24. Finger 30 also defines an upper portion of a notched indentation 32 as viewed in FIG. 3. Annular rim 18 contains at least two gripping fingers 30 that are directly opposite or symmetrically opposed from each other QED St~tEE~' ca o23isi2i Zooo-o~-i4 ~~~V~ 7 n ~ U 1- i C~ ~
1l~A~l~IS
along inner surface 24. However, it will be appreciated to one skilled in the art that more than two fingers could be employed.
Fingers 30 have at least one notch 25 to parmit the fingers to bend towards crown section 14 of dome 12 during insertion of the cap. Fingers 30 5 and notches 25 effectively grip and hold cervical cap 10 over the cervix in order to prevent semen from enterir,~ the cervical canal or to aid in fertilization, depending on the desired result. Gripping fingers 30 and notches 25 essentially provide the effect of a Chinese finger puzzle by gripping the side walls of the cervix and holding the cap when the circumference of the rim 18 is fitted around the cervix and slightly expands. Cervical cap 10 is fixed in place by the use of gripping fingers 30 rather than merely by suction or surface viscosity.
Referring now to FIGS. 4 and 5, an alternate embodiment of the present invention provides a cervical cap 110 comprising a flexible, thin, form-assuming dome 112, an apex portion 114, a base portion 116, and an annular rim 118.
Dome 112 is generally thimble-shaped, with base portion 116 inwardly tapering toward apex portion 114. The outer diameter of rim 118 is greater than that of base portion 116 of dome 112.
Dome 112 further includes a thickened first section 120 and a second section 122. First section 120 is an inactive or non-functional area of the dome, while second section 122 is an active area that most effectively functions as the gripping portion of the dome to the cervix. The second section is preferably less than about one-third of a millimeter, most preferably less than about 0.25 of a millimeter, and still more preferably about 0.22 millimeters thick. The thickened first section is preferahw about 0.35 millimeters thick.
REferring particularly to FIG. 5, rim 118 has an inner surface 124 and an outer surface 126, bottom surface 128, and upper surfaces 130 and 132. Upper surface 130 extends leftward from base portion 116, as viewed in FIG. 5, and terminates at outer shoulder 134. Upper surface 132 extends rightward from base portion 116, as viewed in FIG. 5, and terminates at outer shoulder 136.
Upper surface 132 extends at an acute angle from adjacent base portion 116, preferably, for example, at about an 85 degree angle.
~TfDED SHEET
U2318121 2UUU-~~-14 ~~s 98 ~ o z z b I~~:AI~ ~ 6 J U L ~ 9 ~ 9 Annular rim 1 .8 has generally inwardly direc:ed annular groove 138. The side walls or annular groove 138 extend generally toward bottom surface 128 with the opening of annular groove 138 facing inwardly and upwardly as shown in FIG. 5. Adjacent to annular groove 138 are annular upper rim 140 and annular lower rim lip 142. As illustrated in FIG. 5, both ~pper rim lip 140 and lower rim lip 142 extend generally inwardly and upwardly at an angle acute to dome base portion 116. This lip configuration serves to grip the cervix wall and helps keep the cervical cap in position over the cervix as an alternate embodiment to the configuration shown in FIGS. 2 and 3.
In a further preferred embodiment, cervical cap 110 includes a loop 144 that serves as a handle, facilitates insertion and removal of cap 110, and is integrally-molded with annular rim 118.
It is preferred that the cervical cap of the present invention be constructed of a sperm-impermeable, tear-resistant medical elastomer, such as a silicone rubber, and formed by liquid injection molding. Other suitable materials, such as RTV thermoplastic that can be molded thin enough to be form-conforming and pliant may also be employed.
Preferred materials include a 40 durometer silicone, such as Silastic Q4840 (Dow Corning) or Silicone 4040 (Bayer). When thinly molded, these materials allow for up to a 600% stretch of the molded product.
The elastomer material may or may not be impregnated with biologically active components. These components may include, but are not limited to, spermicides, antibiotics, antifungan and hom-:m ~al replacements. For example, to increase its contraceptive effect, ;~ne cervical cap of the present invention may be pre-treated by coating or impregnating its surface with spermicidal agents during manufacture.
The biologically active components may also assist in fertilization, or may be mixed with sperm within the hollow body of the dome of thA cap in order to achieve the desired result. The use of biologically active materials may stimulate sperm motility, prolong the active life of the sperm or aid in gender selection.
Selectively eliminating or altering the behavior of some sperm by significantly changing the pH may bias the activity of the X or Y sperm, resulting in odds r ~IENDEO ~'-'~-~ ~
.~. ..__ ca o23isi2i Zooo-o~-i4 / U ~. / f?'+
~~~~~ y ~ ~ ~ ~ n 1499 which favor one particular sex over the other. These components may be released therefrom in an amount effective to achieve its purpose during use.
Although the description as set forth is in conjunction with human subjects, it will be further appreciated that the claimed products and methods may ' a readily adaptable for use with animal subjects having : cervix.
While it will be apparent thai the preferred embodiments disclosed are well calculated to provide the advantages and features above stated, it will be appreciated that the invention is susceptible to modification, variation, and change without departing from the proper sc~~e or fair meaning of the subjoined claims.
AMENDED SNEET
Claims (20)
1. An improved method of manufacturing a disposable cervical cap comprising the steps of:
(a) providing an injection point at a top portion location of a heated mold cavity (b) injecting an elastomeric molding material into said heated mold cavity at said injection point, wherein said material flows downwardly throughout said mold cavity, producing a molded cap having a substantially thickened annular rim and a form-assuming dome with a generally thickened top portion having an interior and exterior surface and a substantially thin middle portion;
and (d) removing said molded cap from said mold cavity.
(a) providing an injection point at a top portion location of a heated mold cavity (b) injecting an elastomeric molding material into said heated mold cavity at said injection point, wherein said material flows downwardly throughout said mold cavity, producing a molded cap having a substantially thickened annular rim and a form-assuming dome with a generally thickened top portion having an interior and exterior surface and a substantially thin middle portion;
and (d) removing said molded cap from said mold cavity.
2. The method of claim 1 further comprising the step of creating a reservoir at said top portion location for storing molding material.
3. The method of claim 2 wherein a reservoir is created by thickening said interior surface of said top portion of said molded cap.
4. The method of claim 2 wherein a reservoir .s created by thickening said exterior surface of said top portion of said molded cap.
5. The method of claim 1 wherein said thickened top portion is about 0.35 millimeters thick.
6. The methoa of claim 1 wherein said substantially thin middle portion is about 0.25 miiiimeters.
7. The method of claim 1 wherein said substantially thin middle portion is about 0.22 millimeters thick.
8. An improved disposable cervical cap comprising:
(a) a thin, form-assuming flexible dome having a hollow body and an interior and exterior surface, said dome comprising a top portion having first and second sections, and a base portion; and (b) a flexible, annular rim integrally-molded with said base portion and having an inner and outer surface;
wherein said first section of said top portion of said dome is about 0.35 millimeters thick and said second section of said top portion is about 0.25 millimeters thick.
(a) a thin, form-assuming flexible dome having a hollow body and an interior and exterior surface, said dome comprising a top portion having first and second sections, and a base portion; and (b) a flexible, annular rim integrally-molded with said base portion and having an inner and outer surface;
wherein said first section of said top portion of said dome is about 0.35 millimeters thick and said second section of said top portion is about 0.25 millimeters thick.
9. The cervical cap of claim 8, wherein said second section is about 0.22 millimeters thick.
10. The cervical cap of claim 8, wherein said cap further comprises at least two thin, gripping fingers projecting radially inwardly, and at least two circumferentially spaced apart notches disposed between said fingers to permit said fingers to bend towards said crown section of said dome during insertion of said cap and to effectively grip and hold said cap over said cervix.
11. The cervical cap of claim 8, wherein said annular rim further comprises an inner and outer surface and a bottom surface, said inner surface having an annular groove descending acutely from an inner wall toward said bottom surface of said rim, whereby said annular groove defines an ascending lip on said inner surface of said rim.
12. The cervical cap of claim 11, wherein said rim includes an cuter shoulder beveled with respect to said exterior surface of said dome.
13. The cervical cap of claim 8, wherein said cap further comprises a loop integrally-molded to said annular rim.
14. The cervical cap of claim 8, wherein said cap is comprised of a sperm-impermeable medical elastomer.
15. The cervical cap of claim 8, wherein said cap is comprised of silicone rubber.
16. The cervical cap of claim 8, wherein said cap is comprised of a biologically active material.
17. The cervical cap of claim 8, wherein said cap further comprises sperm within said body of said dome.
18. The cervical cap of claim 8, wherein a biologically active material is mixed with sperm within said hollow body of said dome.
19. The cervical cap of claim 8, wherein said cap is of a size suitable for use with a human.
20. The cervical cap of claim 8, wherein said cap is of a size suitable for use with an animal.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US1998/001264 WO1999037259A1 (en) | 1998-01-21 | 1998-01-21 | Method of manufacturing a disposable cervical cap |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2318121A1 true CA2318121A1 (en) | 1999-07-29 |
Family
ID=22266249
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002318121A Abandoned CA2318121A1 (en) | 1998-01-21 | 1998-01-21 | Method of manufacturing a disposable cervical cap |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP1051137A4 (en) |
| AU (1) | AU6036698A (en) |
| CA (1) | CA2318121A1 (en) |
| WO (1) | WO1999037259A1 (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8454493B2 (en) | 2007-03-28 | 2013-06-04 | Conceivex, Inc. | Conception device and related methods |
| US20080242919A1 (en) * | 2007-03-28 | 2008-10-02 | Melrock Ltd. | Conception cap and related methods |
| US10874432B2 (en) | 2018-05-01 | 2020-12-29 | Conceivex, Inc. | Conception device and related methods |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US806589A (en) * | 1905-07-29 | 1905-12-05 | William H Lawrence | Pessary. |
| US2551618A (en) * | 1948-02-07 | 1951-05-08 | Fram Ette Inc Di | Pessary |
| US3397266A (en) * | 1966-10-31 | 1968-08-13 | Dow Chemical Co | Method and apparatus for the injection molding of elongate cylindrical articles |
| US4093490A (en) * | 1977-04-29 | 1978-06-06 | Ortho Pharmaceutical Corporation | Method of making vaginal diaphragm |
| US4696294A (en) * | 1981-08-31 | 1987-09-29 | Reyner Franklin C | Contraceptive device and related method |
| US4427477A (en) * | 1983-03-11 | 1984-01-24 | Milex Products, Incorporated | Method for making a lipped vaginal contraceptive diaphragm |
| US4743420A (en) * | 1986-09-16 | 1988-05-10 | Sun Coast Plastics, Inc. | Method and apparatus for injection molding a thin-walled plastic can |
| US4785804A (en) * | 1987-07-20 | 1988-11-22 | Page Hanes, Inc. | Disposable cervical cap |
-
1998
- 1998-01-21 WO PCT/US1998/001264 patent/WO1999037259A1/en not_active Application Discontinuation
- 1998-01-21 CA CA002318121A patent/CA2318121A1/en not_active Abandoned
- 1998-01-21 AU AU60366/98A patent/AU6036698A/en not_active Abandoned
- 1998-01-21 EP EP98903657A patent/EP1051137A4/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| EP1051137A1 (en) | 2000-11-15 |
| WO1999037259A1 (en) | 1999-07-29 |
| AU6036698A (en) | 1999-08-09 |
| EP1051137A4 (en) | 2001-09-05 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |