This invention relates to methods of constricting blood out-flow from a penis, and also to constriction rings, to assist in the maintenance of an erection in males with impotency difficulties or problems. Impotence may be defined as the inability to obtain an erection of the penis sufficient to complete sexual intercourse satisfactorily. Impotence may be complete, where no erection at all is achieved, or partial where an erection sufficient to obtain vaginal penetration can be achieved, but which subsequently wanes so that intercourse cannot be completed.

There have been several proposals for devices to assist in the achievement of an erection, and it is also known then to assist the maintenance of that erection by fitting a resilient constriction ring over the base of the penis, to restrict the draining of blood therefrom. Such a ring may be stretched over one end of an applicator, which may form a part of a device to assist the achievement of an erection, and then rolled off that applicator on to the base of the penis, when a sufficient erection has been achieved.

Though a conventional simple annular resilient constriction ring may be employed, it is important that the size of the ring is appropriate for the user's penis, in order that it might exert sufficient restriction and yet be comfortable when in use. Known forms of constriction ring therefore come in a wide range of sizes, but it is not easy for a male already having an impotency difficulty to choose an appropriate diameter of ring, by trial and error. As a consequence, he may have to purchase a number of different sizes of ring, but then never to use some of those sizes. Moreover, the size of the ring required may vary, from day to day. In an attempt to overcome the above problem, one

aspect of this invention provides a method of adjusting the constriction force of a constriction ring which controls the blood out-flow from a penis, comprising circu ferentially stretching a ring having an annulus of a resilient material and defining a principal opening and at least one secondary opening through the thickness of the material, to an extent sufficient to allow the root of the penis to be located within the principal opening, so-positioning the penis and then allowing the ring resiliently to contract therearound to exert a constricting force on the encircled penis, in which method the constricting force is adjusted by cutting through the material of the annulus from a periphery thereof into the secondary opening. The method of this invention allows the adjustment of the constriction provided by a constriction ring, so that a user may achieve the required degree of restriction to maintain an erection, in a comfortable manner-. The cutting through of a part of the radial width of the ring allows either a reduction in the effective cross-sectional area of the ring in the region of the secondary opening, or the incorporation into the circumference of the ring of a greater length of ring material. Either way, for a given degree of circumferential stretch of the ring, so as to enclose a given area, the constriction force may be reduced by effecting said cut through the material of the annulus, into the secondary opening.

Preferably, the cut through the material of the ring into the secondary opening is made prior to the ring being located on a penis. In this case, the cut may be made between the principal and secondary openings of the annulus. However, depending upon the precise configuration of the ring, it may be possible for a user to reduce the constriction by effecting a cut, as appropriate, after the ring has been stretched

over, and released to contract around, his penis.

The ring may be provided with a number of secondary openings, so that a number of cuts may be made through the ring, one into each secondary opening, respectively. It has been found that appropriate adjustment may be achieved if each such cut reduces the effective constriction provided by the ring (or increases the effective size of the ring) by 10 to 15%.

According to a second aspect of the present invention, there is provided an adjustable constriction ring for use in assisting the maintenance of an erection, which ring comprises an annulus of a resilient material defining a principal opening for receiving a penis, and there being at least one secondary opening through the thickness of the material of the annulus, whereby on circumferentially stretching the ring, the effective constricting force exerted thereby for a given stretched circumferential length may be reduced by cutting through the material of the annulus into the secondary opening, thereby increasing the effective size of the ring.

The adjustable constriction ring is specifically adapted for use in the method of this invention, as described above. Such a ring may have a plurality of secondary openings, each of which is defined by a bridging portion joining two spaced-apart regions around the annulus, the length of the bridging portion being different from the circumferential spacing of said two regions of the annulus, whereby the effective size of the ring may be increased by cutting through the shorter of the bridging portion and the material of the annulus between said two regions thereof so as to incorporate the longer of the bridging portion and the annulus in the effective length of the ring. The bridging portion could be formed internally of the annulus though it is preferred for that portion to

be formed externally thereof, the material of the annulus being cut through in order to increase the effective size of the ring.

According to another aspect of this invention, there is provided an adjustable constriction ring for use in assisting the maintenance of an erection, which ring comprises an annulus of a resilient material and defining a principal opening for a penis, the annulus being formed integrally with at least one bridging portion joining and arranged to hold adjacent one another two spaced-part regions of the annulus, whereby a cut made through the material of the bridging portion incorporates both spaced-apart regions within the circumferential length of the ring. The bridging portion may be a relatively narrow web adapted closely to hold together said regions of the annulus; in this case the web may be elongate and arranged to permit its severing for only a part of its length. For example, there may be one or more zones of reduced thickness, or secondary holes through the web, to define sections of the length of the web which may sequentially be severed. As with the previous embodiments, there may be a plurality of essentially similar web-like bridging portions arranged in an internally-spaced manner around the annulus.

Embodiments of ring of this invention are advantageously made from highly extensible synthetic polymers or from natural or synthetic rubbers such as silicon rubber. The materials may display elongations of at least 500%, and may have Shore hardnesses in the region of 40.

By way of example only, certain specific embodiments of constriction ring arranged in accordance with the present invention will now be described in detail, reference being made to the accompanying drawings in which:-

Figure 1 is a plan view of a first embodiment of constriction ring of this invention;

Figure 2 is a cross-section through the ring of Figure 1, taken on line II-II marked thereon; Figures 3A and 3B are views showing the ring of Figures 1 and 2 in use;

Figure 4 shows a second embodiment of constriction ring of this invention;

Figure 5 shows a third embodiment, adjustable through five stages to its maximum size;

Figures 6A to 6D show four further embodiments, all utilising similar principles to the ring of Figure 5, Figures 6C-I, 6C-II and 6C-III being sections taken on lines I-I, II-II and III-III respectively marked on Figures 6C;

Figure 7 is a side view of a cutting tool suitable for use with any of the previous embodiments of ring, either before, during or after use; and

Figure 8 is an edge view of the tool of Figure 7. Referring initially to Figures 1 and 2, there is shown a first embodiment of constriction ring of this invention, which ring is easily adjustable in size to allow a user to achieve a comfortable fit. The ring is moulded from a synthetic polymer such as polychloroprene, or from a silicon rubber material.

The ring material should have a minimum elongation of about 500% but more typically about 600%. The ring is in the form of an annulus 10, which defines a circular inner principal opening 11. Extending through the thickness of the material of the annulus are five secondary openings 12. The external contour of the ring is profiled to define bridging portions 13 around the secondary openings 12. The total cross-sectional area along any radius of the annulus is arranged to be of the same order of magnitude. As shown in Figure 2, area A may be approximately 25mm ² , area B approximately

— — lOmirr and area C approximately 32mm , when the ring is relaxed.

The wall of the annulus defining the principal opening 11 is rounded as shown at 14 in Figure 2, and the outer part of the annulus which defines each secondary opening 12 is given a conical profile as shown at 15 in Figure 2.

As moulded, the annulus defines the smallest size constriction ring - that is to say, a ring which, when in use and so stretched circumferentially to encircle a given area, exerts the greatest degree of constriction for out-flow of blood from a penis. The constriction for that stretch may be reduced by cutting generally radially through the material of the annulus either from the inner periphery or from the outer periphery, to any one of the secondary openings 12. Such a cut serves to reduce the total effective the cross- sectional area of the annulus along a radius including the cat and so allows that part of the annulus to elongate to a greater extent, for a given circumferential street.

Each cut effected into a secondary opening allows the ring to stretch further and so, for a given degree of constriction, the ring will have to encircle a greater area. Alternatively, for a given encircled area, the constriction will be less. In this way, the effective "size" of the ring may be adjusted, even though the ring, when relaxed, will still have substantially the same form and profile irrespective of those cuts. Each cut may increase the effective size of the ring by about 10 to 15%.

Figures 3A and 3B show diagrammatically the ring in use. The part of the ring shown in Figure 3A has not been cut and it can be seen that the ring has been stretched so as to elongate the secondary openings 12. The part 15 of the annulus on the inside of the opening

12 is stretched more than the bridging part 13, and thus offers the greatest resistance to the outward forces of the constriction. When this inner part 15 of the annulus has been cut (as shown in Figure 3B), the circumferential force straightens the outer bridging part 13 which then takes its share of the forces. The ring adjusts to the greater circumference and lessening of the cross-section in this region, and therefore gives less constriction overall. The embodiment of ring shown in Figure 4 is somewhat similar to that illustrated in Figures 1 and 2, but as moulded, the regions 17 of the ring internally of the secondary openings 18 have a greater length than the corresponding regions 19 externally of the openings. Thus, on cutting through an external region 19 at one of the positions shown at 20, ^" the corresponding internal region 17 will be incorporated in the circumferential length of the ring, so increasing its effective diameter. Again, this may increase the effective size of the ring by about 10 to 15%.

As compared to the rings of Figures 1 and 2, the ring of Figure 4 may be favoured by some, since there are no cut edges on the inner surface of the ring. In turn, this allows the use of a harder, or a slightly less resilient, material for the ring, which might give rise to discomfort should such a material be used for the ring of Figures 1 and 2.

The embodiment of Figure 5 is somewhat similar to that of Figures 1 and 2 but relatively narrow bridging webs 26 serve to hold two circumferentially-adjacent portions 27 and 28 of the principal annulus 25 closely next to one another, side-by-side. On cutting through a web, the adjacent two portions 27 and 28 are released from one another, so permitting the incorporation of the combined lengths of those portions in the

circumferential length of the ring. The web 26 is relatively thin as compared to the maximum thickness of the material of the annulus, and the web terminates at a circular secondary opening 29. This serves to reduce the likelihood of the material of the annulus (as distinct from the web) being cut or torn when the web is being cut to adjust the length of the ring. Each cut made through a web again serves to increase the effective size of the ring by approximately 10 to 15%. Figures 6A to 6D show four further embodiments of ring of this invention, all utilising at least one interconnecting bridging portion 30, arranged to be cut to allow adjustment of the ring size. However, in each of these embodiments, the effective diameter of the ring may be adjusted in stages, by cutting through a part only of the length of the bridging portion, for each extra stage of enlargement. Each of these stages is defined by a secondary hole 31 through the respective bridging portion, serving as a stop for the cutting action.

The embodiment of Figure 6A is adjustable in four stages from a minimum size up to a maximum size, by cutting successively along the length of the single bridging portion, each time to the next secondary hole 31. The same adjustability is obtained with the embodiment of Figure 6B, but the unused portion of the ring, projecting from the effective diameter of the ring when in its smaller sizes, is less significant than with the embodiment of Figure 6A. The ring of Figure 6C is similar to that of Figure 6B, but allows for two further stages of adjustment, between its minimum and maximum diameters. The ring of Figure 6D allows the same adjustment as that of Figure 6C, but has the same advantage over the ring of Figure 6C as does the ring of Figure 6B over that of Figure 6A.

Turning now to Figures 7 and 8, there is shown a cutting tool suitable for use with any of the embodiments of ring described above, firstly to allow adjustment of the ring size before use, and secondly to facilitate the removal of the ring, following its use. The tool 35 has a moulded plastics material body 36 having a finger-opening 37 to facilitate use of the tool, the body 36 also defining a V-shaped slot 38 at the end thereof remote from the finger opening. Mounted in the body 36 so as to project across the inner end of the slot 38 is a blade 39 having a cutting edge 40. The end 41 of the body defining part of the slot may taper towards its free end, but still have a rounded profile, to facilitate the insertion of a part of a ring into the slot 38.