CA1146828A - Vaginal diaphragm and method - Google Patents
Vaginal diaphragm and methodInfo
- Publication number
- CA1146828A CA1146828A CA000301674A CA301674A CA1146828A CA 1146828 A CA1146828 A CA 1146828A CA 000301674 A CA000301674 A CA 000301674A CA 301674 A CA301674 A CA 301674A CA 1146828 A CA1146828 A CA 1146828A
- Authority
- CA
- Canada
- Prior art keywords
- diaphragm
- rim
- dome
- thermoplastic
- comprised
- Prior art date
- 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.)
- Expired
Links
Classifications
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Reproductive Health (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Prostheses (AREA)
Abstract
VAGINAL DIAPHRAGM AND METHOD
Abstract of the Disclosure This invention relates to an improved vaginal diaphragm and to a method of making it. The diaphragm of the present invention is prepared from thermoplastic elastomers by means of injection molding.
Abstract of the Disclosure This invention relates to an improved vaginal diaphragm and to a method of making it. The diaphragm of the present invention is prepared from thermoplastic elastomers by means of injection molding.
Description
~:g~
This invention relates to an improved vaginal diaphragm and to a method of making it. In particular, the present invention relates to diaphragms prepared from thermoplastic elastomers.
A vaginal diaphragm commonly comprises an imperforate cup-shaped member made of a thin rubber-like material having a round, somewhat stiff kut resilient rim.
A spring iq generally incorporated therein to maintain the shape of the diaphragm. Opposite sides of the rim can be folded together to form a compact diaphragm unit to facilitate insertion of the diaphragm into the vagina.
The presence of the spring causes the diaphragm to assume a "bow" shape when folded. Without the spring the diaphragm would not be rigid enough to form the "bow"
shape and would, therefore, be difficult to insert. When the folded diaphragm is fully inserted within the vagina, release of the diaphragm establishes the round shape of the diaphragm rim which then makes the sealing engagement with the inner walls of the diaphragm around the cervix, which fits within the diaphragm. The seal formed by the rim prevents ingress of sperm cells into the cervical region.
Present day diaphragms generally consist of a latex membrane and a metal spring encapsulated in latex. They are generally prepared by compression molding. Generally speaking, the latex membrane comprises a molded rim and dome both of which are molded separately from the spring.
.
~a4~
Latex has certain properties which make it less than ideal as a material from which to make diaphragms.
It has been shown that latex because of its polyisoprenic structure will undergo some decomposition by autooxidation.
It has also been shown that some of the stabilizers, emulsifiers and decomposition by-products associated with the use of latex are potential cytotoxicological agents.
Rubber or rubber-like materials and certain thermoplastic substances such as plasticized polyvinyl chloride and polyethylene, for example, have also been employed in the making of diaphragms but these too have certain dis-advantages connected with their use. There is a need, therefore, for a material which can be made into films for use in the fabrication of diaphragms which has the resiliency and flexibility of the prior art materials but does not have the disadvantages inherent in the prior art materials.
One object of the present invention is to provide a vaginal diaphragm comprised of a thermoplas~ic elastomer which has sufficient resiliency and flexibility to allow easy insertion of the diaphragm by the user without the aid of an instrument.
A second object of the invention is to provide a method of making a diaphragm by means of which the several parts of a diaphragm are molded from a thermoplastic elastomer.
, ` .~8B
These and other objects of the invention will be better understood upon reference to the following description and the accompanying drawings in which:
Figure 1 is a perspective view of one embodiment of S the invention;
Figure 2 is a perspective view of the diaphragm of Figure 1 wherein the opposite peripheral portions are squeezed together in preparation for insertion and use;
Figure 3 i8 a top-plan view of the diaphragm of Figure 1 with a spring ring embedded within the rim;
Figure 4 is a sectional view taken at line 4 of the diaphragm of Figure 1.
Figure 5 is a top-plan view of the spring ring which is embedded within the rim of the diaphragm of Figure 3.
-Referring now specifically to the drawings, there i9 shown in Figure 1 a diaphragm 2 having a cup portion 3 and a rim 4. Figure 4 shows a rim and film formed by injection molding. As shown in-Figure 2, when the rim is thus squeezed together, the cup takes on something of a draped condition between the two ends of the bow formed by the rim. This facilitates insertion and proper place-ment of the diaphragm.
In accordance with the present invention, there is provided a vaginal diaphragm comprising a film and rim made from a thermoplastic elastomer. Both the film and the rim may be made from the ~ame or different elastomers.
The film and rim can be formed individually or they can be made and formed in one piece employing the appropriate molding techniques. In the former method, the rim is formed individually by means of injection molding and sealed to a film of the thermoplastic material. The two parts can be ~oined together by various means such as radio frequency technique~, heat sealing or solvent or adhesive bonding, for example. Alternatively, the film and rim can be formed simultaneously by injection molding. The properties of thermopla tic elastomers are such that the rim once formed has the required rigidity but remains freely flexible. When the diaphragm 2 is in position, the rim 4 lie~ flat against adjacent organ surfaces and its flexibility permits it to accommodate itself to the contour of the ~urfaces. However, the rim 4 is rigid enough to hold the cup portion 3 of the diaphragm 2 in its extended position and is completely flexible throughout.
This not only adds to the comfort, but ensures the proper fitting of the diaphragm.
Thermoplastic elastomers are known in the art to be biocompatible and their long-term tissue compatibility is well known. Prior to the present invention, however, thermoplastic elastomers have not been employed in the preparation of diaphragms.
. --~ ORTH 310 Any thermoplastic elastomer may be employe~ to form the films used to prepare the diaphragm of the present - invention. However, in order to achieve a certain degree of softness for the dome and flexibility for the rim, it is preferred to use thermoplastic elastomers having an aver~ge Shore A hardness of about 50 to about 90. The most preferred range is from about 75 to 90. However, softer or harder thermoplastic elastomers can be employed; they can be compounded with compatible polymers such as ethylene 1~ propylene ela~tomers, plasticized polyvinyl chloride, or acrylonitrile-butadiene-styrene terpolymer, for example, to introduce the desired modulus. Suitable thermoplastic elastomers which may be employed in preparing the diaphragms include styrene-butadiene block copolymer, styrene-isoprene block copolymer, ethylene vinylacetate, ethylene propylene copolymer and ethylene propylene terpolymer. The preferred thermoplastic elastomers are the thermoplastic polyurethanes having a polyester or polyether linkage. Suitable thermopl~stic polyurethanes which can be employed include Pellathane (an Upjohn polyether based urethane elastoplastic polymer), Cyanoprene (an American Cyanamid Company fully-reacted polyester or polyether type urethane thermoplastic elastomer), Estane (a B. F. Goodrich Company thermoplastic polyurethane made from polyester or polyether based urethanes), Roylar (a Uniroyal Company thermoplastic polyurethane elastomer), Rucothane (a Hooker Chemical Company polyurethane thermoplastic elastomer), Q-Thane (a Quinn Company polyurethane thermoplastic elastomer) and *
Texin (a Mobay Chemical Company polyurethane thermoplastic elastomer).
* Trademark _~_ Thermoplastic elastomers and the thermoplastic polyurethanes in particular have been found to be superior to the priox art materials in physical strength. Films made from thermoplastic elastomers exhibit superior abrasion resistance and tear resistance properties and have greater tensile strength than the prior art materials.
In addition, the thermoplastic elastomers generally do not show a significant amount of absorption of materials like body enzymes or other proteins; these are properties which make them more desirable materials for the preparation of vaginal diaphragms.
In a preferred embodiment of the invention, the diaphragm consists of a dome-shaped thermoplastic polymeric film and a thermoplastic polymeric rim. The dome-shaped film and the rim can be made from the same or from different types of thermoplastic elastomers. In another embodiment of the invention, a spring comprising a flexible polymeric ring or metal coil may be embedded in ~he rim to give it added rigidity. One suitable form of metal coil comprises a helical spring which is bent into an annulus. The ends of the spring can be joined by any suitable means. They may be intermeshed, welded, or otherwise secured together so that the spring is annular.
The spring itself may be made from any material from which ~5 a spring of suitable characteristics may be formed. The spring, however, is an optional feature of this invention since the physical properties of the thermoplastic elastomers are sufficient to give the rim and diaphragm the rigidity required to assure proper fitting of the diaphragm after insertion.
ORT~ 310 When using a diaphragm of this type, it is common practice to place within the cup a quantity of spermacidal cream or jelly or other spermacide and the diaphragm is then inserted into the vagina. One end of the bow formed when the rims are squeezed together is then easily inserted rearwardly into the vagina, and the diaphragm is readily moved into position. Once the diaphragm has been moved into its proper position, the rim is released and the diaphragm is allowed to return to its original shape.
As previou~ly indicated, the flexible rim readily accommodates itself to the contour of the adjacent organ surfaces.
A~ indicated above, the vaginal contraceptive diaphragms in use today are made of rubber or rubber-like materials and are generally manufactured by compression molding. Flexible springs, where employed, are placed in the mold so that during compression in combination with heat, the molten rubber encaseY the spring and the dome and rim become fused.
The diaphragm of the present invention can be produced by injection molding. The method consists of melting the thermoplastic elastomer and injecting it into a split diaphragm mold containing one or more cavities each consisting of a ring and a thin dome-shaped area. The softened polymeric material is injected into the ring portion of the cavity and then forced into the dome area.
The amount of each shot injected is proportional to cavity size. The cycle time from injection to separation of the diaphragm from the mold can vary according to the speed of injection, temperatures used and efficiency of cooling the mold. In a typical process, the thermoplastic polyurethane i~ heated prior to injection to a temperature high enough to soften the polymer but low enough to prevent chemical breakdown. ThiS is generally accomplished at a temperature between about 400-450F. The mold temperature is generally maintained at about 70-120F during the operation. For a single cavity mold, a cycle time of about 5-10 seconds for filling, 5-10 seconds for holding and about 30 seconds for setup time prior to ejection of the diaphragm from the mold may generally be employed. The temperature and time employed in the molding step are not critical. The particular temperature range and cycle time employed in the molding step, however, will depend upon the particular thermoplastic elastomer employed and the time allowed for the elastomer to set.
Although preferred embodiments of this invention are illustrated, it is to be understood that various modifica-tions may be resorted to without departing from the scope of the invention disclosed and claimed herein.
This invention relates to an improved vaginal diaphragm and to a method of making it. In particular, the present invention relates to diaphragms prepared from thermoplastic elastomers.
A vaginal diaphragm commonly comprises an imperforate cup-shaped member made of a thin rubber-like material having a round, somewhat stiff kut resilient rim.
A spring iq generally incorporated therein to maintain the shape of the diaphragm. Opposite sides of the rim can be folded together to form a compact diaphragm unit to facilitate insertion of the diaphragm into the vagina.
The presence of the spring causes the diaphragm to assume a "bow" shape when folded. Without the spring the diaphragm would not be rigid enough to form the "bow"
shape and would, therefore, be difficult to insert. When the folded diaphragm is fully inserted within the vagina, release of the diaphragm establishes the round shape of the diaphragm rim which then makes the sealing engagement with the inner walls of the diaphragm around the cervix, which fits within the diaphragm. The seal formed by the rim prevents ingress of sperm cells into the cervical region.
Present day diaphragms generally consist of a latex membrane and a metal spring encapsulated in latex. They are generally prepared by compression molding. Generally speaking, the latex membrane comprises a molded rim and dome both of which are molded separately from the spring.
.
~a4~
Latex has certain properties which make it less than ideal as a material from which to make diaphragms.
It has been shown that latex because of its polyisoprenic structure will undergo some decomposition by autooxidation.
It has also been shown that some of the stabilizers, emulsifiers and decomposition by-products associated with the use of latex are potential cytotoxicological agents.
Rubber or rubber-like materials and certain thermoplastic substances such as plasticized polyvinyl chloride and polyethylene, for example, have also been employed in the making of diaphragms but these too have certain dis-advantages connected with their use. There is a need, therefore, for a material which can be made into films for use in the fabrication of diaphragms which has the resiliency and flexibility of the prior art materials but does not have the disadvantages inherent in the prior art materials.
One object of the present invention is to provide a vaginal diaphragm comprised of a thermoplas~ic elastomer which has sufficient resiliency and flexibility to allow easy insertion of the diaphragm by the user without the aid of an instrument.
A second object of the invention is to provide a method of making a diaphragm by means of which the several parts of a diaphragm are molded from a thermoplastic elastomer.
, ` .~8B
These and other objects of the invention will be better understood upon reference to the following description and the accompanying drawings in which:
Figure 1 is a perspective view of one embodiment of S the invention;
Figure 2 is a perspective view of the diaphragm of Figure 1 wherein the opposite peripheral portions are squeezed together in preparation for insertion and use;
Figure 3 i8 a top-plan view of the diaphragm of Figure 1 with a spring ring embedded within the rim;
Figure 4 is a sectional view taken at line 4 of the diaphragm of Figure 1.
Figure 5 is a top-plan view of the spring ring which is embedded within the rim of the diaphragm of Figure 3.
-Referring now specifically to the drawings, there i9 shown in Figure 1 a diaphragm 2 having a cup portion 3 and a rim 4. Figure 4 shows a rim and film formed by injection molding. As shown in-Figure 2, when the rim is thus squeezed together, the cup takes on something of a draped condition between the two ends of the bow formed by the rim. This facilitates insertion and proper place-ment of the diaphragm.
In accordance with the present invention, there is provided a vaginal diaphragm comprising a film and rim made from a thermoplastic elastomer. Both the film and the rim may be made from the ~ame or different elastomers.
The film and rim can be formed individually or they can be made and formed in one piece employing the appropriate molding techniques. In the former method, the rim is formed individually by means of injection molding and sealed to a film of the thermoplastic material. The two parts can be ~oined together by various means such as radio frequency technique~, heat sealing or solvent or adhesive bonding, for example. Alternatively, the film and rim can be formed simultaneously by injection molding. The properties of thermopla tic elastomers are such that the rim once formed has the required rigidity but remains freely flexible. When the diaphragm 2 is in position, the rim 4 lie~ flat against adjacent organ surfaces and its flexibility permits it to accommodate itself to the contour of the ~urfaces. However, the rim 4 is rigid enough to hold the cup portion 3 of the diaphragm 2 in its extended position and is completely flexible throughout.
This not only adds to the comfort, but ensures the proper fitting of the diaphragm.
Thermoplastic elastomers are known in the art to be biocompatible and their long-term tissue compatibility is well known. Prior to the present invention, however, thermoplastic elastomers have not been employed in the preparation of diaphragms.
. --~ ORTH 310 Any thermoplastic elastomer may be employe~ to form the films used to prepare the diaphragm of the present - invention. However, in order to achieve a certain degree of softness for the dome and flexibility for the rim, it is preferred to use thermoplastic elastomers having an aver~ge Shore A hardness of about 50 to about 90. The most preferred range is from about 75 to 90. However, softer or harder thermoplastic elastomers can be employed; they can be compounded with compatible polymers such as ethylene 1~ propylene ela~tomers, plasticized polyvinyl chloride, or acrylonitrile-butadiene-styrene terpolymer, for example, to introduce the desired modulus. Suitable thermoplastic elastomers which may be employed in preparing the diaphragms include styrene-butadiene block copolymer, styrene-isoprene block copolymer, ethylene vinylacetate, ethylene propylene copolymer and ethylene propylene terpolymer. The preferred thermoplastic elastomers are the thermoplastic polyurethanes having a polyester or polyether linkage. Suitable thermopl~stic polyurethanes which can be employed include Pellathane (an Upjohn polyether based urethane elastoplastic polymer), Cyanoprene (an American Cyanamid Company fully-reacted polyester or polyether type urethane thermoplastic elastomer), Estane (a B. F. Goodrich Company thermoplastic polyurethane made from polyester or polyether based urethanes), Roylar (a Uniroyal Company thermoplastic polyurethane elastomer), Rucothane (a Hooker Chemical Company polyurethane thermoplastic elastomer), Q-Thane (a Quinn Company polyurethane thermoplastic elastomer) and *
Texin (a Mobay Chemical Company polyurethane thermoplastic elastomer).
* Trademark _~_ Thermoplastic elastomers and the thermoplastic polyurethanes in particular have been found to be superior to the priox art materials in physical strength. Films made from thermoplastic elastomers exhibit superior abrasion resistance and tear resistance properties and have greater tensile strength than the prior art materials.
In addition, the thermoplastic elastomers generally do not show a significant amount of absorption of materials like body enzymes or other proteins; these are properties which make them more desirable materials for the preparation of vaginal diaphragms.
In a preferred embodiment of the invention, the diaphragm consists of a dome-shaped thermoplastic polymeric film and a thermoplastic polymeric rim. The dome-shaped film and the rim can be made from the same or from different types of thermoplastic elastomers. In another embodiment of the invention, a spring comprising a flexible polymeric ring or metal coil may be embedded in ~he rim to give it added rigidity. One suitable form of metal coil comprises a helical spring which is bent into an annulus. The ends of the spring can be joined by any suitable means. They may be intermeshed, welded, or otherwise secured together so that the spring is annular.
The spring itself may be made from any material from which ~5 a spring of suitable characteristics may be formed. The spring, however, is an optional feature of this invention since the physical properties of the thermoplastic elastomers are sufficient to give the rim and diaphragm the rigidity required to assure proper fitting of the diaphragm after insertion.
ORT~ 310 When using a diaphragm of this type, it is common practice to place within the cup a quantity of spermacidal cream or jelly or other spermacide and the diaphragm is then inserted into the vagina. One end of the bow formed when the rims are squeezed together is then easily inserted rearwardly into the vagina, and the diaphragm is readily moved into position. Once the diaphragm has been moved into its proper position, the rim is released and the diaphragm is allowed to return to its original shape.
As previou~ly indicated, the flexible rim readily accommodates itself to the contour of the adjacent organ surfaces.
A~ indicated above, the vaginal contraceptive diaphragms in use today are made of rubber or rubber-like materials and are generally manufactured by compression molding. Flexible springs, where employed, are placed in the mold so that during compression in combination with heat, the molten rubber encaseY the spring and the dome and rim become fused.
The diaphragm of the present invention can be produced by injection molding. The method consists of melting the thermoplastic elastomer and injecting it into a split diaphragm mold containing one or more cavities each consisting of a ring and a thin dome-shaped area. The softened polymeric material is injected into the ring portion of the cavity and then forced into the dome area.
The amount of each shot injected is proportional to cavity size. The cycle time from injection to separation of the diaphragm from the mold can vary according to the speed of injection, temperatures used and efficiency of cooling the mold. In a typical process, the thermoplastic polyurethane i~ heated prior to injection to a temperature high enough to soften the polymer but low enough to prevent chemical breakdown. ThiS is generally accomplished at a temperature between about 400-450F. The mold temperature is generally maintained at about 70-120F during the operation. For a single cavity mold, a cycle time of about 5-10 seconds for filling, 5-10 seconds for holding and about 30 seconds for setup time prior to ejection of the diaphragm from the mold may generally be employed. The temperature and time employed in the molding step are not critical. The particular temperature range and cycle time employed in the molding step, however, will depend upon the particular thermoplastic elastomer employed and the time allowed for the elastomer to set.
Although preferred embodiments of this invention are illustrated, it is to be understood that various modifica-tions may be resorted to without departing from the scope of the invention disclosed and claimed herein.
Claims (9)
1. A vaginal diaphragm comprising a thin cup-like member which is dome-shaped having an annular somewhat stiff but resilient rim for making sealing engagement with the walls of the vagina, said diaphragm being sufficiently flexible to enable opposite sides of the rim to be folded to facilitate insertion thereof into the vagina, wherein said dome-shaped member and said rim are comprised of the same or different thermoplastic polyurethane elastomers.
2. The vaginal diaphragm of Claim 1 wherein the rim and dome are comprised of the same thermoplastic elastomer.
3. The vaginal diaphragm of Claim 1 wherein the rim and dome are comprised of different thermoplastic elastomers.
4. The vaginal diaphragm of Claim 1 wherein the thermoplastic polyurethane elastomer has a Shore A hardness of between 75-90.
5. The vaginal diaphragm of Claim 1 wherein a spring is molded integrally within said rim.
6. The method for making a diaphragm which comprises molding a rim for the diaphragm and integrally molding a dome with said rim, said rim and said dome being comprised of the same or different thermoplastic, polyurethane elastomers.
7. The process of Claim 6 wherein the thermoplastic polyurethane elastomer has a Shore A hardness of between 75-90.
8. The process of Claim 6 wherein the dome and the ring are comprised of the same thermoplastic elastomer.
9. The process of Claim 6 wherein the dome and the ring are comprised of different thermoplastic elastomers.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US79238277A | 1977-04-29 | 1977-04-29 | |
| US792,382 | 1977-04-29 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1146828A true CA1146828A (en) | 1983-05-24 |
Family
ID=25156716
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000301674A Expired CA1146828A (en) | 1977-04-29 | 1978-04-21 | Vaginal diaphragm and method |
Country Status (4)
| Country | Link |
|---|---|
| JP (1) | JPS54139292A (en) |
| BE (1) | BE866498A (en) |
| CA (1) | CA1146828A (en) |
| ZA (1) | ZA782456B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103298519B (en) | 2010-11-12 | 2016-09-14 | 犹他大学研究基金会 | Intravaginal device for the transmission of controlled type lubricant |
-
1978
- 1978-04-21 CA CA000301674A patent/CA1146828A/en not_active Expired
- 1978-04-27 BE BE187216A patent/BE866498A/en not_active IP Right Cessation
- 1978-04-28 JP JP5221178A patent/JPS54139292A/en active Granted
- 1978-04-28 ZA ZA00782456A patent/ZA782456B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JPS6340101B2 (en) | 1988-08-09 |
| ZA782456B (en) | 1979-11-28 |
| JPS54139292A (en) | 1979-10-29 |
| BE866498A (en) | 1978-10-27 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |