WO1989007428A1

WO1989007428A1 - Banded collagen condoms and method and apparatus for banding same

Info

Publication number: WO1989007428A1
Application number: PCT/US1989/000443
Authority: WO
Inventors: Harold A. Morelli; Eugene K. Lubbs
Original assignee: Schmid Laboratories, Inc.
Priority date: 1988-02-11
Filing date: 1989-02-03
Publication date: 1989-08-24
Also published as: JPH02503159A; EP0357720A1; EP0357720A4

Abstract

This invention relates collagen condoms advantageously banded to provide improved characteristics during use. The invention also relates to a method and apparatus for banding collagen condoms. According to the invention, an elastic band (3) is incorporated into the collagen gel body (11) of the condom (1) as an integral part thereof. The band (3) is sealed within adjacent layers of collagen film, made from collagen gel, said layers of film forming the condom body.

Description

BANDED COLLAGEN CONDOMS AND METHOD AND APPARATUS FOR BANDING SAME

This invention relates to collagen condoms with flexible elastic banding that provides improved characteristics during use. The invention also relates to a method and apparatus for banding collagen condoms.

Background of the Invention

It is desirable that a condom be held firmly and comfortably in place during use. Natural rubber or synthetic elastomer condoms, because they are highly elastic, are made smaller than the erect penis. These condoms are designed to stretch slightly when put on, and to contract firmly around the penis while being worn. The condom is held in place in this way during intercourse. These condoms are satisfactory in strength and thinness, and can be economically manufactured. However, they are notably inferior in sensitivity, are water impermeable, and are ineffective heat conductors. The elastic material relied upon to keep the condom in place often results in discomfort, is unduly dependent on the size of the penis, is known to become brittle, tear or fail during use more often than other types of condoms, and may deteriorate in the presence of commonly used petroleum-based lubricants.

Condoms made from natural membranes, such as lamb cecum, are satisfactory in strength and thinness, and offer improved sensitivity, permeability, and comfort. These condoms are virtually inelastic, and therefore must be made somewhat larger than the erect penis. To hold the condom in place, a slit is cut on each side of the open end of the condom, forming two flaps which can be folded down over an elastic band and glued in place. This simple gluing process can be used because the membrane is ry, and because i"t is supple due to the plasticizing effect of naturally occurring fat. Thus, the condom is held in place by an elastic band having a circumference adapted to contract around the penis, and not by contraction of the condom body.

In one banding method, the dry tubular cecum is placed mitten-like over a wide flat form, which flattens the condom. Starting at the top open end of the condom, slits about one-half inch long are cut on each side of the flattened .membrane, making two flaps. A rubber band is place over each cecum and is positioned just below, or at the apex, of the slits. Glue is applied in a stripe to both sides of the flattened condom. The flaps are folded over the rubber band and pressed into the glue. When the glue is dry, the condom is removed from the form and is wetted prior to subsequent processing.

This banding method requires that each condom be individually handled, and there is a high risk that incipient tears at the apex of the condom, at or neax the slits, will occur during processing. In addition, natural ceca are limited in availability and cecum condoms are expensive to manufacture. The final product also suffers from unavoidable surface irregularities which remain after processing of the thin natural membranes.

Efforts to develop condoms having the desirable strength and comfort characteristics of ceca-based products, but at a lower cost and without dependence on a natural resource of increasing rarity, have led to the development of collagen-based condoms, made from collagen gels. Homogeneous collagen gels capable of forming smooth films of uniform strength, and suitabl for use as a condom material, are disclosed in applicant's U.S. Patent, No. 4,626,286, the subject matter of which is incorporated herein by reference. Collagen condoms and methods for manufacturing them are also disclosed in U.S. Patent No. 4,406,853 and No. 4,349,026.

Thin film articles made from collagen gels have superior breaking and tear strength, and improved homogeneity, thinness, smoothness, sensitivity and appearance. They are also convenient and economical to manufacture.

Collagen condoms are formed by repeatedly dipping a phallic mandrel into an aqueous collagen gel, withdrawing the mandrel and drying the resulting coating. The dipping process i repeated until a collagen film having the desired thickness is obtained. In one embodiment, the mandrel may be rotated in two directions, to achieve a film that is uniformly strong in both directions.

Collagen condoms must be moist in order to readily remove them from the dipping mandrel, and they remain moist throughout subsequent processing and sale.

Collagen condoms are inelastic, like those made from ceca, and they are made larger than the erect penis. A reliable means of holding the condom in place during use is therefore needed, but the known banding means have been unsatisfactory.

Glue cannot be applied to the collagen condom while it is wet.

Wheni dry, the condom material tends to be brittle, because the regenerated collagen film contains no fat. Efforts to slit and fold the dry brittle film for the known gluing process often result in tears and fractures in the condom. To delicately remov each condom from its mandrel while dry, and glue each band in place individually according to the known method, followed by a rewetting step for processing, is difficult and costly. Collage condoms also cannot be banded merely by rolling the top of the condom before curing, using the techniques heretofore employed for banding latex condoms.

These problems and disadvantages have been overcome, according to the present invention, by advantageously incorporating an elastic banding means into the condom during th dipping process. Objects of the Invention

It is an object of the invention to provide a strong, thin, resilient, and homogeneous regenerated collagen gel condom having a circumferential integral elastic band firmly and integrally incorporated therein, thereby achieving a product

.*» that is low in cost, but superior in strength, comfort and reliability.

It is another object of the invention to provide a novel and advantageous method of banding collagen condoms. It is yet another object of the invention to provide an apparatus for banding condoms according to the method of the invention.

These and other objects of the present invention will be apparent to those skilled in the art, in light of the accompanying description, drawings, and appended claims.

Summary of the Invention

Prior to dipping a phallic-shaped mandrel into a bath of collagen gel, an elastic band is placed at the top of the mandrel, away from the blunt tip. The mandrel is then dipped blunt-end first and coated with gel, to a depth just short of the elastic band. The gel is dried into a film, preferably in a drying tunnel. In a preferred embodiment, the mandrel is plastic or glass and may also be tapered toward the head to aid removal of -the .finished condom from the mandrel. In another embodiment, the dipping step may be achieved by raising a tank containing the collagen gel up and over the blunt tip of the mandrel, until the mandrel is submerged in the gel to the desired depth. This process is repeated as often as desired, to obtain a continuous film of desired uniform thickness and open at the top, thus forming a collagen condom. Preferably, 2-3 coats of collagen gel are applied. In a preferred embodiment, the mandrel is rotated during the application of each gel coat, and the direction of rotation can be reversed after each application.

When the desired number of gel coats have been applied and dried, the elastic band is rolled over the integrated layers of film and positioned near the top of the open end. Water is applied to at least a portion of the film above the band, using a spray, moistened sponge, brush, or similar applicator. This softens the film and makes it flexible. A coating of gel is applied with a brush or similar applicator below and optionally above the band. An upper flap comprising the moist flexible fil is folded down over band and pressed against the gel coating below the band. One or more additional coats of gel, extending over the entire band position, are applied to the entire mandrel by dipping, withdrawing and drying as previously described. In this manner, the band is enfolded and sealed, and becomes an integral part of the condom. This method is suitable for either rolled or folded condoms.

In a preferred embodiment, particularly for folded --condoms, the mandrel is advantageously provided with a cone- shaped portion at the top, which improves the band enfolding step. In another embodiment, specifically for rolled condoms, the cone extension to the mandrel is not necessary, the intermediary application of water and gel can be omitted, and the upper flap need not be folded over the band. Instead, additional coats of gel are applied to the mandrel directly over the band, and when processing is completed, the upper region of the moist condom incorporating the band is rolled down to create a donut- shaped item ready to be unrolled over the erect penis.

Brief Description of the Drawings Fig. 1 is a schematic view of a banding method for folded condoms, according to the invention;

Fig. 2 is a schematic view of a banding method for rolled condoms, according to the invention;

Fig. 3a is a plan view of an apparatus for banding condoms according to the invention;

Fig. 3b is a side view of an apparatus for banding condoms according to the invention; and

Fig. 4 is a schematic view of an automated apparatus according to the invention.

Detailed Description

The present invention provides a method for producing condoms comprising collagen films having an integral elastic band. First, a collagen gel is prepared and an^' elastic band is placed at the upper end of a phallic mandrel having a lower blunt end. Second, a set of primary coats of collagen gel are sequentially applied to the mandrel (not to the elastic band) and each coat is dried into a homogeneous layer, to form a condom body. Third, the elastic band is lowered over the condom body to a predetermined position, water is applied to at least a portion of the film above the band, and a stripe of collagen gel is applied to the condom body below and optionally above the band. Fourth, the uppermost portion of the condom body is folded over the elastic band in the form of a continuous flap, so that the band is enfolded and enclosed by the flap, which bonds with the condom body along the stripe of gel. Finally, additional coats of gel are applied to the condom body, over and including the flap and the enfolded elastic band, to complete the condom body and integrally seal the flap and band within the finished condom.

Example 1 - Preparation of Collagen Gel

The condoms of the invention are made using a collagen gel. Collagen gel was prepared from Bovine digital flexor tendon, which was ground through a plate with 3/16" diameter holes. From coarsely ground tendon containing 35.69 kg solids, a 853.79 g portion was dispersed into 13.62 kg of water at 15 degrees C, to which had been added 0.128 g of the enzyme Rhozyme-41. The total dispersion was passed once through a Stephen Microcutter with a -1mm blade clearance. The comminuted mass was allowed to stand at 24 degrees C to allow the enzyme to work. After 17 hours, 11.99 kg H20 containing 183 g starch, 17.5 ml formaldehyd (5%) and 140 ml lactic acid (88%) was stirred into the enzyme treated slurry. The resulting acidified mass was passed once through the microcutter to enhance swelling and to homogenize th resultant gel. The homogenized gel was transferred to a Ross planetary mixer and stirred under vacuum for 20 minutes to remov entrained air. The gel had a solid content of 2.17% and a viscosity of 2760 cps.

Example 2 - Preparation and Banding of Folded Condoms With reference to Fig. la, a ceramic, glass or plastic mandrel 1 with a blunt or phallic tip 12 and an enlarged cone- shaped portion 2 at the upper end is used for making banded condoms. Before dipping, a rubber band 3 with a 3" circumferenc and a 0.063" square cross section is placed on the mandrel in a first band position 4, above the cone-shaped portion 2. Three primary coats of gel 5, prepared according to Example l, are applied to the mandrel 1, up to a first dipping position 6 below the first band position 4, show in Fig. la as the region A.

In a preferred embodiment, the first dipping position is the top of the cone-shaped portion 2. Each gel coat is applied by dipping the mandrel l into the gel, withdrawing it from the gel at a speed of 1.83 inches/second, while rotating th mandrel 1 about its vertical axis at about 0.115 revolutions/inc of vertical travel. The direction of mandrel rotation is change for each dip. After each dip the gel coating is dried for about ^^""minutes in a stream of air at 80 degrees C (not shown) . The dipping and withdrawing steps can also be achieved by raising a tank containing the gel up and over the blunt end of the mandrel 1, until it is submerged to the depth of the first dipping position 6. Each dip lasts approximately 30 seconds. In 5 the embodiment using the raised tank, the tank should move upward at a slow speed upon fist contact of the gel with the mandrel, whereafter the dipping speed can be increased. The mandrels can be rotated during dipping into and withdrawal from the gel

After the third coat of gel is applied and dried, the 0 band 3 is rolled down over the three layers or primary coats 5 of dried film to a final band position 7 as shown in Fig. lb, at the bottom of the cone-shaped portion 2 of the mandrel 1. Using a moistened sponge, water was applied to a flap portion 8 of the film defined by the band 3 and the first dipping position 6, 5 shown in Fig. lb as the region B.

In a preferred embodiment, the flap portion 8 covers the cone-shaped portion 2. Water is applied to soften the dried gel or film forming the flap portion 8 and make it flexible. Then, with a brush, a 1/2 inch wide strip 9 around the mandrel 1

20 and immediately below the band 3, shown in Fig. lb as the region C, is coated with the same collagen gel employed in the dipping step.

Referring to Fig. lc, the moistened, supple flap portion 8, overlying the cone, is folded down over the band 3

25. from a first flap position 8a through a plurality of intermediate positions illustrated as 8b, to a final flap position 8c. In its final position 8c, the flap portion 8 is pressed against the gel strip 9 below the band 3 to enclose the band within the flap portion 8.

Two more secondary gel coats 10, extending about 1/4 inch above the band 3, shown in Fig. Id as the region D, are applied and dried in the manner already described, sealing and incorporating the band 3 within an envelope region 11. The fina product, when removed from the mandrel 1, comprises a banded condom according to the invention. After dipping, and especially after the final dip, the gel may be treated with about 0.25% ammonia and rinsed with deionized water. The gel may also be treated with glutaraldehyde, as a tanning agent.

Example 3 - Preparation and Banding of Rolled Condoms A collagen gel is prepared according to Example 1.

Referring to Fig. 2, a ceramic, glass or plastic mandrel 21, without th cone-shaped portion, but having a top portion 22 and a tip 32, was used for an alternate banding method. As shown in Fig. 2a an elastic band 23 of the type previously described is placed on the phallic mandrel 21, approximately 10 inches up fro the tip, in a first band position 24. Two primary layers of gel 25 are formed on the mandrel 21 by dipping, withdrawing and drying according to the method previously described. The mandre 21^' is_ dipped into the gel to a depth of 7 1/2 inches, to a first dipping position 26. After the second primary gel coat 25 is dry, the band 23 is roiled down over the dry film to a final band position 27, 7 inches above the mandrel tip 32, as shown in Fig. 2b. Three secondary gel coats 30 were applied to a level 1/2 inch above the band 23 and dried in the manner described, and as illustrated in Fig. 2c. Thus, the band 23 was incorporated into the structure of the final condom product, within an envelope region 31.

After the final gel coat was dried, the mandrel was treated with a 0.25% ammonium hydroxide solution for 3 minutes, and then was washed with deionized water for 6 minutes, followed by treatment with a 0.06% glutaraldehyde solution for 3 minutes and a final 3 minute rinse with deionized water. After the final rinse, the banded condoms were removed from the dipping mandrels and washed for 30 minutes in deionized water.

Example 4 - Apparatus for Bandinσ Collagen Condoms

In a preferred embodiment, the flap portion 8 is folded over the band 3 with the apparatus of Fig. 3a and 3b. A compressed air ring 50 is raised over the dried primary coating 5, past the band 3 in its final position 7, with the air off. The air ring has an annular groove 51 with feeding holes 52 which selectively blow against the mandrel 1 at an angle chosen to direct the air at and then under the upper leading edge of the condom body and flap portion 8, preferably of 30 degrees. When the compressed air is turned on and the ring 50 is lowered, it confronts the upper portion of the mandrel and the upper leading edge of the flap portion 8, and acts to separate the flap from the mandrel, and to push the flap down and over the elastic band 3. The flap 8, which has been turned inside out, then seizes against the condom body and the primary coats 5, within the region C of Fig. lb. The air is pressurized, preferably at 70-80 PSI.

When the flap portion 8 seizes against the condom body, the air ring 50 continues its descent and exits the mandrel 1 at its tip 12. The mandrel 1 is then dipped again, as described, until in a preferred embodiment the resulting condom product has five gel layers with an integral flap portion 8 enveloping the band 3 within an envelope region 11, thereby affording maximum resistance to band separation by unusual tugging force.

Example 5 - Automated Banding Apparatus The air ring 50 can be raised and lowered manually, or by motorized or pneumatic means, and indeed the entire apparatus can be automated by conventional means. One such means is schematically illustrated in Fig. 4.

The air ring 50 is mounted on a supporting armature (not shown) which serves to raise and lower the air ring 50 about a central axis A, which corresponds with the central vertical axis 70 of the mandrel 1. After the primary gel coat 5 are applied to the mandrel 1 in the manner previously described, and the band 3 is lowered to its final position 7, the air ring 50 is raised up and over the bottom of the mandrel along the axis A, by conventional pneumatic means, from a rest position (not shown) below the mandrel to a ready position above the flap portion 8 (shown) .

When the ring 50 is in the ready position, a water supply means 59 supplies water to a water applicator 60, which selectively moistens the primary coats 5 within a region proximate to the band 3 and generally coextensive with the flap portion 8. In the embodiment shown, the water applicator 60 moves by conventional means into an operative position proximate to the flap region 8 after the air ring 50 reaches its ready position.

After the primary coats 5 of the flap region 8 are moistened, a gel applicator 62 moves by conventional means into an operative position proximate to the flap region 8. The gel applicator 62 is supplied with collagen gel by a gel supply 61. In the embodiment shown, the gel applicator 62 is a brush, which applies one or more stripes of gel to the primary coats 5 within a region proximate to the band 3 and generally coextensive with the flap portion 8.

In a preferred embodiment, the mandrel 1 is rotated about the axis A by the shaft 70 during the application of water by the water applicator 60 and the application of gel by the gel applicator 62. The water applicator 60 and gel applicator 62 ar supported by conventional structural elements which are not show in-the figures. When the band 3 and flap portion 8 are moistened with water and striped with gel, the air ring 50 is activated while i its ready position. First, compressed air, preferably at 70-80 PSI is supplied to an annular groove 51 (Figs. 3a and 3b) by an air supply means 55. The compressed air is circumferentially directed through feeding holes 52, which direct a plurality of air streams at the upper surface of the mandrel 1, and at the leading edge of the flap portion 8 of the primary coats 5. The position of the ring 50 and the angle of the holes 52 are chosen so that the air streams are directed between the leading edge of the flap portion 8 and the mandrel 1, causing the flap portion 8 to separate from the mandrel 1. Contemporaneous with this separation, the air ring 50 is lowered over the mandrel 1 and the primary coats 5, with the air on, so that the flap portion 8 is pushed downward and is folded over the elastic band 3, to form a continuous envelope of gel around the band 3. When the flap portion 8 is folded, it is turned inside out, so that its outer surface becomes an inner surface that is pressed into contact with the pre-moistened and gel-striped region of the primary coats 5 proximate to the band 3. In this manner, the flap portion 8 is sealed around the band 3 in the form of a continuous envelope.

The compressed air may be turned off once the air ring 50 is lowered past the folded flap portion 8, and in a preferred embodiment the mandrel 1 is not rotated during the folding step, i.e. while the compressed air is on. Once the air ring 50 is turned off and lowered past th mahdrel 1 and back to its ready position, additional coats of ge are applied and dried over the mandrel, including the flap portion 8 and the band 6, in the manner described in previous examples, but not shown in Fig. 4. In this manner, the elastic band 3 and flap portion 8 are integrally sealed within the finished condom body, resulting in a superior banded collagen condom according to the invention.

Example 6 - Comparative Tests _>

The strength of the integral elastic banding of the invention was compared with the prior art in a series of experiments.

A 1/2 inch ring containing the rubber band was cut from 8 condoms of each type. The force required to break the collagen ring enclosing the rubber band was measured on an Instron testing machine. As shown in TABLE 1, the average breaking force for rings from condoms made on cone-shaped mandrels by folding the flap over the band was 6.24 kg. The average force required to break rings from condoms made on straight mandrels by dipping over the bands was 4.32 kg.

In operation, the banded condom according to the invention, comprising a solidified collagen gel and an integrated elastic band, provides superior strength, comfort, and reliability — all at relatively low cost.

The elastic bands are held more securely in condoms banded -using the method of the invention. This is important becaus-e^' inadvertent separation of the band from the condom sheath can cause the condom to fail, and may result in an undesired pregnancy.

TABLE 1

BREAKING FORCE (Kg) OF COLLAGEN RING ENCOMPASSING BAND

THE PRIOR ART

It will be understood by skilled .practitioners that the foregoing description and examples are illustrative, and do not serve to limit the scope of the invention or the appended claims,

Claims

WE CLAIM:

1. A banded collagen condom comprising: a condom body of collagen gel having an open end, a blunt end, and inner and outer surfaces, an elastic band encircling the outer surface of said condom body, and a flap comprising a portion of the condom body extending a predetermined distance from said open end, enclosing said elastic band within said distance, and adhering to said outer surface.

2. A banded collagen condom comprising: a plurality of integrated layers of collagen film solidified from regenerated collagen gel by applying a corresponding plurality of coats of said gel over a phallic mandrel in at least two coating stages, to obtain a condom body of homogeneous composition and predetermined size and length, having a predetermined thickness over each of at least one region within its length, and being open at one end, and an elastic band proximate to the open end of said condom body, sealed during the second of any two said coating stages between any two or more adjacent layers of said collagen film, said adjacent layers forming an envelope around said elastic band, which band is incorporated thereby into said condom body as an integral part thereof, said envelope additionally comprising at least one flap of said collagen film folded over said elastic band before the second of any two said coating stages.

3. A banded condom according to claim 2, wherein said flap is in the form of an unbroken circumferential cuff having inner and outer surfaces, said cuff being folded over said elastic band and having a leading edge defined by said open end of said layers forming said condom body prior to the second of any two said coating stages, said leading edge and at least part of said inner surface being placed in circumferential contact with said condom body prior to the second of any two said coating stages, and said leading edge and at least part of said outer surface being covered by at least one said layer of collagen fil during at least one of any of said second coating stages.

4. A banded condom according to claim 3, wherein said cuff is in the shape of a section of a cone.

. .

5. A banded condom according to claim 2, wherein each of said coatings is applied by dipping less than the entire length of the mandrel headfirst into a bath of said collagen gel to a predetermined depth.

6. A banded collagen condom comprising: a plurality of integrated layers of collagen film solidified from regenerated collagen gel by applying a corresponding plurality of coats of said gel over a phallic mandrel to obtain a condom body of homogeneous composition and predetermined size, thickness and length, and being open at one end, and an elastic band proximate to the open end of said condom body, sealed between any two adjacent layers of said collagen film, said adjacent layers forming an envelope around said elastic band, which band is incorporated thereby into said condom body and becomes an integral part thereof, said envelope additionally comprising at least one flap of said collagen film in the form of a circumferential cuff having inner and outer surfaces and having the shape of a sectio of a cone, said cuff being folded over said elastic band, at least part of said inner surface being placed in circumferential contact with said condom body and at least part of said outer surface being covered by at least one said layer o collagen film.

7. A banded collagen condom according to claim 2 wherein each said layer has a uniform thickness extending over the entir length of the condom body.

8. A banded collagen condom according to claim 6 wherein each said layer has a uniform thickness extending over the entir length of the condom body.

9. A method of banding collagen condoms comprising the steps of: placing an elastic band in a first band position on a phallic mandrel having a head and a tail end, said first positio being proximate to the tail end, applying a coat of regenerated collagen gel over a bod region of said mandrel extending from the head toward the tail end, said body region approaching but not including the first banding position, drying said coat to form a corresponding collagen film layer having a size and shape corresponding to the mandrel over said body region and being open toward said tail end; repeating said applying and drying steps a predetermined number of times, to form a corresponding number of integrated inner collagen film layers extending over at least part of said body region, each said layer having a homogeneous composition and a predetermined thickness, the layers together forming an inner sheath extending over said body region of said mandrel, displacing said band in the direction of said head to a final band position proximate to said open end and encircling said inner sheath, resuming and repeating said applying and drying steps a predetermined number of times, to form a corresponding number of integrated outer collagen film layers extending over at least a portion of said body region and covering said final banding position, said outer layers forming an outer sheath, said band being enveloped by said inner and outer sheaths, and said sheath together forming a condom body having said band incorporated therein as an integral part thereof, and removing said condom body and integral band from said mandrel.

10. A method of banding collagen condoms according to clai 9, comprising the additional steps, after said displacing step and prior to said resuming step, of: moistening at least part of a tailward region of said inner sheath proximate to said band in its final band position, said tailward region terminating at said open end, applying a coat of said regenerated collagen gel to a headward region of said inner sheath proximate to said band in its final band position, folding at least part of said tailward region over sai band in its final band position, said folded part forming at least one flap having an inner and an outer surface, and contacting at least part of the inner surface of said • flap with said coated headward region, thereby enfolding said band.

11. A method of banding collagen condoms according to clai 10, wherein said flap is in the form of one unbroken circumferential cuff.

12. A method according to claim 11 wherein said cuff is in the shape of a section of a cone.

13. A method according to claim 12 wherein said mandrel is provided with a cone-shaped tailward extension, at least part of which is included within said body region.

14. A method according to claim 9 wherein said applying an drying steps provide that each said layer is of predetermined an uniform length_, and thickness.

15. A method according to claim 10 wherein said applying and drying steps provide that each said layer is of predetermine and uniform^' length and thickness.

16. A method according to claim 9 wherein said applying step comprises dipping said mandrel headfirst into a bath of sai regenerated collagen gel.

.

17. A method according to claim 10 wherein said applying step comprises dipping said mandrel headfirst into a bath of sai regenerated collagen gel.

18. A method according to claim 10 wherein said repeating and resuming steps are performed between one and two times, ^thereby providing an inner sheath having from two to three integral film layers, and an outer sheath having from one to two said film layers.

19. A method according to claim 10 wherein said drying step is performed in a drying tunnel.

20. A method according to claim 16 wherein said mandrel is plastic and wherein said mandrel is rotated during at least said dipping step.

21. A method according to claim 17 wherein said mandrel is plastic and wherein said mandrel is rotated during at least said dipping step.

22. A method according to claim 10 wherein said folding and contacting steps comprise blowing compressed air against said moistened tailward portion at a predetermined angle.

23. A method according to claim 11 wherein said folding and contacting steps comprise blowing compressed air against said moistened tailward portion at a predetermined angle.

24. A method according to claim 12 wherein said folding an contacting steps comprise blowing compressed air against said moistened tailward portion at a predetermined angle.

25. An apparatus for banding collagen condoms comprising: phallic mandrel having a lower head end, an upper tail end, a central vertical axis, and an elastic band in a first band position proximate to the uppermost portion of said tail end, means for selectively rotating said mandrel about its vertical axis, a supply of regenerated collagen gel proximate to said mandrel, first means for selectively and sequentially applying plurality of primary homogeneous coats of said collagen gel from said supply of regenerated collagen gel to the surface of said mandrel, each said primary coat having a uniform thickness over predetermined length of the mandrel and extending from and including said head end to an. upper edge proximate to but not including said elastic band in its first position, first means for drying each said primary coat to form solidified homogeneous primary layer of collagen gel, said plurality of primary layers forming an inner sheath about said mandrel, means for displacing said elastic band from its first band- position to a predetermined second band position below said edge and surrounding said inner sheath and proximate to said tai end, second means for selectively and sequentially applying a plurality of secondary homogeneous coats of said collagen gel from said supply of regenerated collagen gel to the surface of said inner sheath, each said secondary coat having a uniform thickness extending from said head end over a predetermined length of the mandrel including said elastic band, second means for drying each said secondary coat to form a solidified homogeneous secondary layer of collagen gel, said plurality of secondary layers forming an outer shea~h about said inner sheath and said elastic band, the inner and outer sheaths together forming a condom body, means for removing said condom body from said mandrel.

26. An apparatus according to claim 25, additionally comprising: means for moistening said inner sheath at least within a region proximate to said elastic band in its second position, means for applying at least one stripe of collagen gel to said inner sheath within a region at least proximate to said elastic band in its second position, and means for folding a continuous upper circumferential flap portion of said inner sheath down and over said elastic ban in- its second position, said flap portion extending axially from said edge to said elastic band in a first unfolded position, and from said elastic band to a lower terminal position proximate to said band in a second folded position.

27. Apparatus according to claim 25, wherein said mandrel is made of a material selected from the group consisting of plastic, glass and ceramic.

28. Apparatus according to claim 26, wherein said mandrel is provided at its tail end with a cone-shaped portion having a lower apex, is made of a material selected from the group consisting of plastic, glass and ceramic, and wherein said displacing means displaces said elastic band to a second positio corresponding to said lower apex.

29. Apparatus according to claim 25, wherein said means fo supplying collagen gel comprises a bath of collagen gel below an proximate to* said head end of said mandrel and perpendicular to said central axis.

30. Apparatus according to claim 26, wherein said means fo supplying collagen gel comprises a bath of collagen gel below an proximate to said head end of said mandrel and perpendicular to. said central axis.

31. Apparatus according to claim 25, wherein said first an second means for applying collagen gel are the same, and said first and second means for drying are the same.

32. Apparatus according to claim 26, wherein said first and second means for applying collagen gel are the same, and said first and second means for drying are the same.

33. Apparatus according to claim 29 wherein at least one of said means for applying collagen gel comprises a means for dipping said mandrel in said bath.

34. Apparatus according to claim 30 wherein at least one of said means for applying collagen gel comprises a means for dipping said mandrel in said bath.

35. Apparatus according to claim 29 wherein at least one of said means for applying collagen gel comprises a means for raising said bath over said mandrel.

36. Apparatus according to claim 30 wherein at least one of said means for applying collagen gel comprises a means for raising said bath over said mandrel.

37. Apparatus according to claim 25 wherein said drying means comprises a stream of air directed toward said mandrel and having a temperature of approximately 80 degrees C.

38_. Apparatus according to claim 26 wherein said drying means 'comprises a stream of air directed toward said mandrel and having a temperature of approximately 80 degrees C.

39. Apparatus according to claim 26, wherein said moistening means comprises a water supply and a movable nozzle selectively directed toward said mandrel, and said means for applying a stripe of gel comprises a secondary gel supply and a selectively movable brush adapted to transfer gel from said secondary gel supply to said sheath.

40. Apparatus according to claim 26, wherein said folding means comprises: a supply of compressed air, a plurality of air nozzles circumferentially confronting said mandrel and adapted to selectively direct compressed air in the direction of the mandrel from the supply of compressed air, said plurality of nozzles being selectively movable in a direction parallel to the central axis of said mandrel, between a lower rest position beneath the head of said mandrel and a predetermined upper tail position above said elastic band in its first position.

41. Apparatus according to claim 39, wherein said plurality of nozzles are oriented at a predetermined angle with respect to the surface of the mandrel at least during an operative distance -^"of travel within a region proximate to said elastic band in its second position.

42. Apparatus according to claim 41, wherein said predetermined angle is an acute angle with respect to the surface of said mandrel.

43. Apparatus according to claim 42, wherein said angle is 30 degrees.

44. Apparatus according to claim 39, wherein said compressed air is delivered at a pressure of from 70 to 80 PSI.

45. Apparatus according to claim 26, wherein said folding means comprises: a supply of compressed air, a ring having a front and rear face, a plurality of nozzles circumferentially disposed about said front face, and an annular chamber between said faces and in communication with said supply of compressed air and with said plurality of nozzles, said nozzles being adapted to selectively direct compressed air in the direction of the mandrel, and said ring being selectively movable in a direction parallel to the central axis of said mandrel between a lower rest position beneath the head of said mandrel and a predetermined upper tail position above said elastic band in its first position.

46. Apparatus according to claim 45, wherein said plurality of nozzles are oriented at a predetermined angle with respect to said front face, and with respect to the surface of the mandrel at least during an operative distance of travel within a region proximate to said elastic band in its second position.

47. Apparatus according to claim 46, wherein said predetermined angle is an acute angle with respect to the front face of the ring and the surface of said mandrel.

48. Apparatus according to claim 47, wherein said angle is 30 degrees.

49. Apparatus according to claim 45, wherein said compressed air is delivered at a pressure of from 70 to 80 PSI.