Balloon designed to expand a foreskin, system and kit for expanding a foreskin, mold and method for forming a balloon.
Patent Information
- Application Number
- BR112021024568
- Authority / Receiving Office
- BR · BR
- Patent Type
- Patents
- Current Assignee / Owner
- Publication Date
- 2026-09-01
Smart Images
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Abstract
Description
1 / 19 Balloon designed to expand a foreskin, system and kit for expanding a foreskin, mold and method for forming a balloon. FIELD OF TECHNIQUE
[001] This disclosure refers, in general, to balloons that are used to expand an orifice, such as the foreskin of a male individual. BACKGROUND
[002] Phimosis is a condition in which the male foreskin is unable to retract properly from the head of the penis (or glans) due to an unusually tight foreskin. Many men with this condition are born with it. Phimosis can also be caused by trauma, infection, or autoimmune disease. Zipper-related trauma is a well-documented cause of phimosis, and lichen sclerosus and balanitis xerotica obliterans (BXO) are autoimmune diseases known to trigger phimosis.
[003] Over time, phimosis can also be exacerbated by tearing of the foreskin opening, resulting in scarring. Phimosis can result in a higher likelihood of infection, an accumulation of smegma (the white substance under the foreskin), ballooning of the foreskin during urination, pain during sex, and a loss of sensation during sex. A more serious condition, paraphimosis, occurs when a tight foreskin recedes over the head of the penis and remains there, constricting blood flow. This can quickly lead to permanent damage and / or loss of the penis.
[004] The devices used to treat phimosis insert a balloon under the foreskin where the balloon is then gently inflated, which causes the foreskin to be stretched. This procedure is repeated over a course of a few days to a few months to treat phimosis. A problem with current balloons Petition 870210117444, dated 12 / 17 / 2021, page 10 / 34 2 / 19 is that they do not always remain in the correct position under the foreskin and they do not always have reproducible inflammation characteristics, which can make it difficult to provide consistent treatment for a patient.
[005] It should be understood that a reference in the present invention to prior art does not constitute an admission that the publication forms part of the common general knowledge in the art, in Australia or any other country. SUMMARY
[006] The disclosure provides, in a first aspect, a balloon for expanding an orifice. The balloon comprises a hollow body having a head, the body being closed at a distal end and open at a proximal end, the head extending from the distal end. The balloon also comprises a hollow neck positioned between the open proximal end and the distal end of the body. The neck wall thickness is greater than the head wall thickness.
[007] One advantage of having a neck wall thickness that is greater than a head wall thickness is that the neck may not expand, or there may be substantially minimized neck expansion, when the balloon is inflated. This can help ensure that the expansion of the head during inflation is approximately uniform, which can help ensure that constant pressure is applied to the orifice being expanded by the balloon. For example, when treating phimosis, the approximately uniform expansion of the balloon can apply constant pressure to the foreskin. The approximately uniform expansion of the balloon head can also help ensure that the balloon does not slip out of the orifice during use.
[008] In one embodiment, the wall thickness of the head at the distal end may be greater than the wall thickness of the remainder. Petition 870210117444, dated 12 / 17 / 2021, page 11 / 34 3 / 19 of the head. Having a head wall thickness at the distal end (e.g., a tip / end region of the head) that is greater than the wall thickness of the rest of the head may allow the balloon to expand in a radial direction more than in a longitudinal direction extending from the proximal end to the distal end of the body during inflation. In some embodiments, the head may expand only in a radial direction during inflation, i.e., the balloon head does not expand in the longitudinal direction. Limiting head expansion to a radial direction can help ensure that the balloon exerts only a radial force on the orifice rather than a force in a longitudinal direction. For tissue such as the foreskin, minimizing expansion in the longitudinal direction may help prevent the balloon from being ejected from under the foreskin during inflation.
[009] In one embodiment, a first neck end may extend from the proximal end of the body to a second, remote neck end. The first neck end may comprise a peripheral rim that projects outward from it. The neck may comprise a waist intermediate to its first and second ends. The wall thickness of the waist may be less than the wall thickness of a remainder of the neck. The waist may be formed as a progressive narrowing of the wall thickness of a section of the neck. Having a waist may help provide the body with some flexibility to allow the body to be removed from a mold during manufacturing. The waist may also help reduce the amount of material needed to form the balloon.
[010] An external diameter of the neck can be substantially constant for a given neck length. The external diameter of the neck can be in the range of about 5 mm to about 15 mm, such as about 10 Petition 870210117444, dated 12 / 17 / 2021, page 12 / 34 4 / 19 mm. One portion of the neck may have an external diameter that is substantially constant, and another portion of the neck may have an external diameter that is not constant. The head may have a diameter in the range of about 6 mm to about 18 mm in a deflated state. The opening at the proximal end may have a diameter in the range of about 5 mm to about 10 mm. In one embodiment, the diameter of the opening is about 8 mm. The proximal end may be configured to fit over an inflation device.
[011] The disclosure provides, in a second aspect, a balloon for expanding an orifice. The balloon comprises a hollow body having a head, the body being closed at a distal end and open at a proximal end with a longitudinal axis extending between them. The head extends from the distal end. The balloon is configured so that, when the balloon is inflated, the head expands in a greater radial direction than in the longitudinal direction and the diameter of the body remains approximately constant during inflation.
[012] A balloon length extending along the longitudinal direction may remain approximately constant during inflation. The body may define a neck that is positioned between the head and the proximal end. A neck diameter may remain substantially unchanged during inflation. The balloon of the second aspect may otherwise be as defined for the first aspect.
[013] In one embodiment of the dissemination, the balloon may be made from silicone. The body and head may be unitary with each other. The balloon may be self-supporting so that, in a deflated state, the balloon does not fall on itself. Having a self-supporting balloon may assist a user in inserting the balloon into an orifice. For example, when the orifice is an ear, a self-supporting balloon may allow a user to insert the balloon. Petition 870210117444, dated 12 / 17 / 2021, page 13 / 34 5 / 19 in the ear regardless of patient orientation, and when the orifice is the space between the foreskin and the head of a penis, the self-supporting balloon can assist with placement of the balloon under the foreskin.
[014] The disclosure also provides, in another aspect, a system for expanding an orifice, comprising: a balloon as set forth above, and an inflation device for inflating the balloon.
[015] The system may also comprise a flow regulator to regulate the flow of fluid into and out of the balloon. The flow regulator may be used to maintain the balloon in an inflated state. The system may also comprise a connector used to connect the balloon to the inflation device. The connector may function to attach the proximal end of the balloon to the flow regulator.
[016] The disclosure also provides, in another aspect, a kit comprising a system, as set forth above, and a container for housing the system. The container may be a box. The box may be made of cardboard and / or plastic. The kit may include instructions for operating the system.
[017] The disclosure also provides, in another aspect, a mold for forming a balloon which is used to expand an orifice. The balloon comprises a hollow body having a head, the body being closed at a distal end and open at a proximal end, and a hollow neck extending from the open proximal end of the body. The mold comprises a projection having a first region for forming the body and a second region for forming the head. The first region has a first diameter and the second region has a second diameter, and the first diameter is smaller than the second diameter.
[018] The protrusion may also include a third region to form a waist in the neck. The third region may have a third diameter. Petition 870210117444, dated 12 / 17 / 2021, page 14 / 34 6 / 19 which is smaller than the first diameter. The second region may comprise a recess that forms part of the proximal end of the body. The mold may further comprise a female section to receive the boss. The female section may have a hole that has an approximately constant inner diameter. The balloon may be as set forth above. The boss may be formed from two or more components that are connectable to each other to form the boss.
[019] A method for forming a balloon is also disclosed, the balloon being used to expand an orifice. The method comprises: providing the mold as set forth above; applying a balloon precursor to the mold; and curing the balloon precursor to form the balloon.
[020] The balloon precursor may be a silicone precursor material that is cured to form a silicone-based balloon. The method may further comprise a post-curing step to additionally cure the balloon. The balloon may be as set forth above. BRIEF DESCRIPTION OF THE FIGURES
[021] The modalities will be described only by way of example with reference to the attached non-limiting Figures, in which: Figure 1 is a side view of an embodiment of a publicity balloon in a deflated state when mounted on a protrusion. Figure 2 is a side view of the balloon from Figure 1 in an inflated state. Figure 3 shows a partial cross-section of one type of balloon. Figure 4 shows a partial cross-section of another type of balloon. Figure 5 shows a cross-section of another type of balloon. Petition 870210117444, dated 12 / 17 / 2021, page 15 / 34 7 / 19 Figure 6 shows a side view of one embodiment of a publicity balloon in a deflated state when mounted on a protrusion. Figure 7 shows a cross-section of a mold that is used to form a type of balloon. Figure 8 shows a male mold component that is used to form a modality of a balloon. DETAILED DESCRIPTION OF THE MODALITIES
[022] A balloon is shown to expand an orifice. Referring to Figures 1 and 2, balloon 10 has a hollow body in the form of a hollow cylinder 16. Cylinder 16 has a (first) proximal end in the form of a base 12. Extending from the base 12 is a neck 22. The neck 22 is integrally formed with the cylinder 16. As best shown in Figure 3, cylinder 16 has an inner face 34 and an outer face 32. The diameter of the outer face 32 remains approximately constant from the base 12 to the neck 22. Extending from the neck 22 is a head 18. Terminating at a distal end (i.e., tip) of balloon 10 is a tip-shaped region in the form of an end 20. The neck 22 has a first end close (proximal) to the base 12 and a second end distant (distal) from the base 12. Simply put, each end of the neck 22 is axially distanced from the other.
[023] A strip-shaped bearing 26 is positioned on the base 12 on the outer face 32. The strip 26 acts to apply a compressive force when the base 12 is situated on a fitting that is associated with an inflation device to prevent fluid leakage when the balloon 10 is inflated with fluid. In Figures 1 and 2, the fitting is in the form of a protrusion 14. An outer surface of the protrusion 14 is in contact with the inner face 34 when the base 12 is situated on the protrusion 14, and the strip 26 acts Petition 870210117444, dated 12 / 17 / 2021, page 16 / 34 8 / 19 to compress the inner face 34 onto the outer surface of the protrusion 14. An auxiliary ring connector 28 is also fitted onto the cylinder 16 near the base 12 to compress the cylinder 16 onto the protrusion 14. The protrusion 14 may form part of a flow regulator. An auxiliary ring 28 acts as a fastener, like a saddle clamp, to apply a radially compressive force to the cylinder 16. The auxiliary ring 28 helps ensure that the base 12 of the balloon 10 remains attached to the protrusion 14. However, the auxiliary ring 28 is not required in all embodiments; see, for example, Figure 6 in which the balloon 10 is mounted on the protrusion without the auxiliary ring. Additionally, the resistance strip 26 is not required in all embodiments.
[024] Cylinder 16 has a waist positioned between the base 12 and the neck 22. In the embodiment shown in Figures 1 to 3, the waist is in the form of a channel or groove 24 that extends circumferentially around the inner face 34. The groove 24 has a depth that extends from the inner face 34 towards the outer face 32. The groove 24 is formed as a progressive narrowing of the wall thickness of cylinder 16.
[025] In the embodiment depicted in Figures 1 to 3, a wall thickness of cylinder 16 near base 12 is approximately similar to a wall thickness of neck 22. In some embodiments, neck 22 has a wall thickness that is less than or greater than the wall thickness of cylinder near base 12. Regardless of the wall thickness of neck 22 and cylinder 16, a wall thickness of groove 24, as defined by the narrowest thickness between the inner face at location 34a and the outer face at location 32a, is less than the wall thickness of base 12. The wall thickness of groove 24 is also less than the wall thickness of neck 22. The narrowest thickness between inner face 34a and the Petition 870210117444, dated 12 / 17 / 2021, page 17 / 34 9 / 19 The outer face 32a of groove 24 is generally located at the maximum groove depth, for example, at location 34a. The presence of groove 24 means that neck 22 is defined by a circumferential projection that has a semi-hemispherical or curved cross-section extending radially inward. However, in embodiments where groove 24 is positioned along cylinder 16 at a location that is more towards the base 12 than neck 22, neck 22 may simply be defined by the end region of cylinder 16. A wall thickness of neck 22 is defined by the greatest distance between the inner face 34 and the outer face 32. A longitudinal axis of balloon 10 is represented by the dashed line 36.
[026] The groove 24 is not required in all embodiments and, as shown in Figure 4, the wall thickness of cylinder 16 is constant from base 12 to neck 22.
[027] In the embodiments shown in Figures 1 to 4, the head 18 has a bulbous (mushroom) shape. However, in one embodiment, the head 18 is cylindrical and extends axially from the neck 22, as shown in Figure 5.
[028] The thickness of a side wall portion 19 of the head 18 is less than the wall thickness at the neck 22. The end 20 of the head 18 has a wall thickness that is greater than the side wall portion 19. The end 20 has a wall thickness that is generally less than the wall thickness of the neck 22, although in some embodiments the end 20 may have a wall thickness equal to that of the neck 22. The transition from the neck 22 to the head 18 is given as a progressive narrowing of the wall thickness of the cylinder 16 from the neck 22 to the side wall portion 19. Petition 870210117444, dated 12 / 17 / 2021, page 18 / 34 10 / 19
[029] The specific dimensions of an embodiment of balloon 10 in a deflated state (or uninflated state or unexpanded state) will be described with reference to Figure 5. It should be noted that the dimensions described in relation to the embodiment of Figure 5 are only illustrative and are not intended to limit the dimensions of the balloon as set out in this disclosure.
[030] In the balloon shown in Figure 5, the base 12 has a wall thickness A' which, in one embodiment, varies from about 1.0 mm to 2.0 mm, such as about 1.20 mm. In a specific embodiment, A' is 1.22 mm. The cylinder 16 has a wall thickness extending from the inner face 34a to the outer face 32a in the range of about 0.3 mm to 0.7 mm, such as about 0.50 mm. In a specific embodiment, a wall thickness extending from the inner face 34a to the outer face 32a is 0.52 mm. The neck 22 has a wall thickness B' in the range of about 1.0 mm to 2.0 mm, as well as about 1.20 mm. In a specific embodiment, B' is 1.21 mm. The side wall portion 19 of the head 18 has a wall thickness C' in the range of about 0.2 mm to 0.6 mm, such as about 0.3 mm to 0.4 mm. In a specific embodiment, C' is 0.35 mm. The end 20 has a wall thickness D' in the range of about 0.7 mm to 1.1 mm, such as about 0.90 mm. In a specific embodiment, D' is 0.89 mm.
[031] Referring again to Figure 5, a length I' from the base 12 to an intermediate point 16' of the cylinder 16 extending along an axial direction 36 of the balloon 10 varies from about 10 mm to 15 mm. In one specific embodiment, the length I' is about 13.5 mm. A length H' from the intermediate point 16' to a distal end 16'' of the cylinder 16 extending along the axial direction 36 of the balloon 10 varies from about 10 mm to 15 mm. In one specific embodiment, a length H' is about 12 mm. Petition 870210117444, dated 12 / 17 / 2021, p. 19 / 34 11 / 19 The neck 22 has a length G' extending along the axial direction 36 of the balloon 10 that varies from about 1.0 mm to 3.0 mm. In a specific embodiment, a length G' is about 2.0 mm. A length E' of the head 18 extending along the axial direction 36 of the neck 22 to the end 20 varies from about 10 mm to 15 mm. In a specific embodiment, a length E' is about 12.50 mm, such as 12.48 mm.
[032] Referring again to Figure 5, in one embodiment, a radius J' from the axis 36 to the inner wall 34 of the base 12 varies from about 3.0 mm to 4.5 mm. In a specific embodiment J' is 3.80 mm. In a specific embodiment, a radius K' from the longitudinal axis 36 to the outer wall 32 of the base 12 is about 5 mm. It should be noted that the radii of the various features from the axis 36 to the inner and outer walls of the respective feature will be dependent on the wall thickness of the respective feature and the overall diameter of the balloon 10. The dimensions of the balloon 10 described with reference to Figure 5 are applicable to the embodiments of the balloon 10 shown in Figures 1 to 4.
[033] In the embodiments shown in the Figures, cylinder 16, base 12, resistance strip 26, groove 24, neck 22, head 18 and end 20 are unitary with each other. However, in some embodiments, cylinder 16, base 12, resistance strip 26, groove 24, neck 22, head 18 and end 20 are not unitary with each other.
[034] When balloon 10 is inflated, such as when balloon 10 is used to stretch a patient's foreskin, a fluid passes through the protrusion 14, through the base 12 and into an interior space of balloon 10. The fluid is usually air, but may optionally be a liquid. Since the head 18 has the thinnest wall thickness among the cylinder 16, base 12 and neck 22, the head has the greatest stretching capacity (i.e., elasticity), which means that the head 18 is the first region of balloon 10 to expand. In addition Petition 870210117444, dated 12 / 17 / 2021, page 20 / 34 12 / 19 of this, the wall thickness of the neck 22 is chosen so that the neck 22 does not expand, or expands only minimally, when the balloon 10 is inflated. The wall thickness of the cylinder 16 (e.g., groove 24 and base 12) is also selected so that, during the inflation of the balloon 10, the cylinder 16 does not expand, i.e., the diameter of the cylinder 16 remains substantially unchanged. See, for example, Figures 1 and 2, where, in the inflated state (Figure 2), the diameter of the outer face 32 of the cylinder 16 including neck 22 remains substantially unchanged compared to the neck 22 in a deflated state (Figure 1). One advantage of balloon 10 is that the head region 18 expands preferentially compared to the cylinder 16 (i.e., body), and this means that, for small and delicate orifices, the head 18 is less likely to slip out of the orifice.In other words, the wall thickness of the neck 22 and cylinder 16 relative to the wall thickness of the head 18 helps to keep the fluid in the head (i.e., the distal end) of the balloon 10 in an inflated state.
[035] For example, for current balloons used to dilate and stretch the foreskin, there is no preferential expansion formed inside the balloon and the shaft and head expand proportionally to each other. One result of this is that, for foreskins that are sufficiently tight, the balloon head is unable to expand and instead the shaft expands in place of the head. This results in the shaft applying pressure to an exterior of the foreskin that causes the head to come out from under the foreskin. This makes it difficult to treat patients reproducibly. Since the cylinder 16, including neck 22, does not expand during inflation, it is unlikely that the cylinder 16 (i.e., body) will apply a pulling pressure to the foreskin, which helps to keep the balloon head 18 under the foreskin. Therefore, a balloon 10 embodiment helps to reduce the occurrence of the head coming out of an orifice during use. Petition 870210117444, dated 12 / 17 / 2021, page 21 / 34 13 / 19
[036] It should be noted that the neck 22 and cylinder 16 may expand slightly during inflation, thereby increasing their respective diameters, but such expansion is minimal, i.e., the diameter of the neck 22 and cylinder 16 may expand by < 10%. In one embodiment, the head 18 expands to up to 100% of its deflated state. For example, in embodiments where the head 18, in a deflated state, has a diameter of about 12 mm and the neck 22 has a diameter of about 10 mm, the head 18, in the inflated state, may expand to have a diameter of up to 24 mm, such as 18 mm, and the diameter of the neck 22 may remain relatively unchanged, such as 10.5 mm. In one embodiment, the head 18 has an outer diameter in a deflated state in the range of about 6 mm to about 18 mm. In one embodiment, cylinder 16 has an outer diameter in a deflated state in the range of about 8 mm to about 12 mm.In some embodiments, the outer diameter of cylinder 16, in the deflated state, remains unchanged regardless of the diameter of the head 18 in the deflated state. In some embodiments, the neck 22 expands relative to the base 12, and the head 18 expands relative to the neck 22.
[037] A longitudinal length of balloon 10 extends in a direction that extends from base 12 to end 20, as depicted in dashed line 36. In one embodiment, the head 18 occupies approximately 20% to 30% of the length of balloon 10. In one embodiment, the neck 22 is positioned approximately 60% to 75% of the distance from base 12 to end 20. In one embodiment, a length of balloon 10 ranges from about 30 mm to about 50 mm. In one embodiment, the head extends from about 10 mm to about 25 mm from end 20 towards base 12. In one embodiment, a distance from base 12 to neck 22 ranges from about 20 mm to about 30 mm. Petition 870210117444, dated 12 / 17 / 2021, page 22 / 34 14 / 19
[038] In the embodiments shown in the Figures, the end 20 of the head 18 has a wall thickness that is greater than the side wall portion 19. Similar to the neck 22, the end 20 functions to limit the expansion of the balloon 10 in a region close to the end 20. Limiting the expansion of the end 20 helps ensure that the head 18 expands in a radial direction rather than in a longitudinal direction of the balloon 10 (e.g., in a direction along line 36 extending away from the base 12). In some embodiments, an overall length of the balloon 10 remains substantially unchanged (i.e., <15% change) between a deflated and inflated state.
[039] Balloon 10 is produced from a resiliently deformable material. In one embodiment, balloon 10 is formed from a material that allows balloon 10 to be self-supporting so that, in a deflated state, balloon 10 does not collapse on itself, as depicted in Figure 1. In one embodiment, the balloon is formed from a silicone-based material. For example, the balloon may be formed from a silicone rubber produced from a liquid silicone rubber precursor SILPURAN® 6000 / 40. In another embodiment, the balloon is formed from a polymeric material, such as rubber.
[040] Balloon 10 is used to dilate and stretch an orifice, such as that formed by a foreskin. In order to stretch a foreskin, the head 18 of balloon 18 is first inserted under the foreskin. Generally, the end 20 is positioned to be at or near the head of the penis. In one embodiment, an insertion implement, such as a rod, is used to push the head 18 under the foreskin. The insertion implement may be inserted into the interior of balloon 10 to help push the head 18 by Petition 870210117444, dated 12 / 17 / 2021, page 23 / 34 15 / 19 below the foreskin. Since balloon 10 can be self-supporting, this can help insert balloon 10 and keep balloon 10 under the foreskin.
[041] Balloon 10 is inflated once balloon 10 is positioned under the foreskin. To inflate balloon 10, an inflation device is connected to the base 12 and a fluid passes into the balloon 10. The bump 14 forms part of an inflation device. An example of an inflation device includes a syringe or a compression bulb. In some embodiments, the inflation device has a flow regulator, such as a tap or valve, which can be used to regulate a flow of fluid into and out of balloon 10. The valve may be a one-way valve. The flow regulator is operable to maintain balloon 10 in an inflated (expanded) state. In the embodiments of Figures 1 and 2, the auxiliary ring 28 is placed over balloon 10 to secure balloon 10 to the bump 14. However, the auxiliary ring 28 is not required in all embodiments, as shown in Figure 6.
[042] In some embodiments, a kit is provided comprising the balloon 10 and a container housing the balloon 10. In some embodiments, a kit is provided comprising the system comprising the balloon 10, and a container housing the system. The container may be made from cardboard and / or plastic. The container may contain recesses to house the balloon 10 and / or system. For example, a container may contain a first recess to hold a plurality of balloons 10, and a second recess to hold the system.
[043] Referring to Figure 7, a mold 100 is shown which is used to form the balloon 10. The mold 100 has a first component in the form of a female component 110. The female component 110 has a cavity 120. In one embodiment, the cavity 120 is defined by an elongated blind hole that has an approximately constant diameter and a rounded base. Petition 870210117444, dated 12 / 17 / 2021, pp. 24 / 34 The upper region of cavity 120 is defined by the cavity side wall 112. Extending from the cavity side wall 112 is a curved wall 124. One end of cavity 120 is defined by a base wall 126. The base wall 126 extends from the curved wall 124. The cavity side wall 112, curved wall 124, and base wall 126 are collectively referred to as the cavity wall. The cavity wall defines an outer surface of the balloon 10. In one embodiment, the female component 110 is formed from Calmax tool steel.
[044] Mold 100 has a second component in the form of a male component which, in Figure 7, is shown as boss 114. Boss 114 has a base 125 that extends from a base block 131. The base block 131 is engaged in the female mold 110 to limit movement of the boss 114 in the cavity 120. Extending from the base 125 is a first boss region in the form of base region 127 to form the base 12 and cylinder 16 of the balloon 10. A second boss region in the form of head region 118 extends from the base region 127. The head region 118 is used to define the head 18 of the balloon 10. One diameter of the base region 127 is smaller than one diameter of the head region 118. Positioned between the base region 127 and the Head region 118 is an intermediate region 116 which is used to define groove 24 of balloon 10.The diameter of the intermediate region 116 may be the same as or smaller than the diameter of the head region 118, but the diameter of the intermediate region 116 is larger than the diameter of the base region 127.
[045] In the embodiment of Figure 7, the neck 22 is formed around a neck region 128 that is positioned between the intermediate region 116 and the head region 118. In embodiments of mold 100 that do not have the intermediate region 116, the neck 22 is defined by the transition of the base region 127 Petition 870210117444, dated 12 / 17 / 2021, page 25 / 34 17 / 19 for the head region 118. In one version, the 114 bump is formed from 7000 series aluminum.
[046] The dimensions of balloon features 10 described with reference to Figure 5, such as wall thickness, length, and diameter, are at least in part defined by the dimensions of the cavity 120, base region 127, head region 118, intermediate region 116, and neck region 128. Adjusting the dimensions of the cavity 120, base region 127, head region 118, intermediate region 116, and / or neck region 128 will adjust the dimensions of the respective balloon feature 10. For example, decreasing the diameter of the base region 127 while maintaining the diameter of the cavity 120 will increase the wall thickness of the cylinder 16.
[047] In one embodiment, the boss 114 is formed from two or more components that are connectable to each other. The formation of the boss from two or more components can aid in the removal of a balloon from the mold. In one embodiment, the base region 127, intermediate region 116, and optionally the neck region 128 are defined by a first boss component, and the head region 118 and optionally the neck region 128 are defined by a second boss component that is connectable to the first boss component. In one embodiment, the neck region is positioned on the first boss component, on the second boss component. The neck region 128 can be defined when the first boss component and the second boss component are connected to each other.
[048] During use, the bump 114 is inserted into the cavity 120. An annular space 122 formed between the cavity wall and an outer surface of the bump defines a volume that is filled with a balloon precursor material that is cured to form the balloon. In one embodiment, the material of Petition 870210117444, dated 12 / 17 / 2021, pp. 26 / 34 Balloon precursor 18 / 19 is liquid silicone rubber precursor SILPURAN® 6000 / 40. Once balloon 10 is formed, the bump 114 is removed from the cavity 120 and then balloon 10 is removed from the bump 114. In one embodiment, after balloon 10 is formed, the balloon is post-cured. Post-curing can be at an elevated temperature, such as about 200 °C. However, post-curing is not necessary in all embodiments. A suitable release agent is used to allow balloon 10 to be released from the mold 100.
[049] One embodiment of a boss is shown in Figure 8 (multiple bosses are shown in Figure 8). Boss 150 has base region 127 and intermediate region 116. Boss 150 extends from a base block 131. In Figure 8, the base block 131 has a plurality of bosses 150 located on it. A female component that is used to form the mold 100 is provided with a respective number of cavities to accommodate each boss among the plurality of bosses 150.
[050] Although the specific embodiments of balloon 10 have been described with reference to stretching a foreskin, the balloon of the present disclosure is not limited to use for stretching and dilating a foreskin and may be used to dilate and stretch other orifices, such as an ear canal, nasal passage, sinus, anus and vagina.
[051] Furthermore, the balloon embodiments described above were designed for specific use in stretching a foreskin. However, for use with other orifices, other features of the balloon 10, such as a portion of the cylinder 16, may expand similarly or more than the head 18 during use. For example, in some embodiments, the balloon, in an expanded form, may adopt a “dog bone” shape, with two expanded portions being axially spaced apart from each other. Petition 870210117444, dated 12 / 17 / 2021, page 27 / 34 19 / 19
[052] Having described the subject matter of the present disclosure in detail and by way of reference to specific embodiments thereof, it is noted that the various details disclosed in the present invention should not be considered as implying that these details refer to elements that are essential components of the various embodiments described in the present invention, even in cases where a particular element is illustrated in each of the drawings accompanying the present description. Furthermore, it will be evident that modifications and variations are possible without departing from the scope of this disclosure, including, but not limited to, the embodiments defined in the appended claims. More specifically, although some aspects of the present disclosure may be identified in the present invention as preferred or particularly advantageous, it is contemplated that the present disclosure is not necessarily limited to these aspects.
[053] In the following claims and in the preceding description, except where the context requires otherwise due to expressed language or necessary implication, the word comprehend or variations, such as comprehends or comprehending, is used in an inclusive sense, that is, to specify the presence of the established features, but not to exclude the presence or addition of additional features in various modalities. Petition 870210117444, dated 12 / 17 / 2021, pages 28 / 34
Claims
1 / 5 CLAIMS 1. Balloon (10) configured to expand a foreskin, the balloon characterized in that it comprises: a hollow body (16) having a head (18) and a neck (22), the body (16) being closed at a distal end and open at a proximal end with a longitudinal axis (36) extending between them, the head (18) extending from the distal end of the body (16), the body (16) defining the neck (22) positioned between the head (18) and the proximal end, a first end of the neck (22) extending from the proximal end of the body (16) to a second remote end of the neck (22), the body (16) having an inner face (34) and an outer face (32) defining a body wall thickness (16);wherein a neck wall thickness (22) is greater than a head wall thickness (18), a head wall thickness (18) at the distal end is greater than the wall thickness of a remaining head (18), and, in a deflated state, an outer diameter of the head (18) is greater than an outer diameter of the neck (22), such that, when the balloon (10) is inflated, the head (18) expands in a greater radial direction than in a longitudinal axis direction (36) and a diameter of an outer face (32) of the neck (16) remains constant over the length of the neck (22) during inflation.; 2. Balloon (10), according to claim 1, characterized in that a length of the balloon (10) extending along the direction of the longitudinal axis (36) remains constant during inflation.
3. Balloon (10), according to claim 1 or 2, characterized in that the first end of the neck (22) comprises a peripheral rim (26) projecting outwards from it. Petition 870260074140, dated 24 / 07 / 2026, page 14 / 18 2 / 5 4. Balloon (10), according to any one of claims 1 to 3, characterized in that the neck (22) comprises a waist (24) intermediate to its first and second ends.
5. Balloon (10), according to claim 4, characterized in that the wall thickness of the waist (24) is less than the wall thickness of the neck remainder (22).
6. Balloon (10), according to claim 4 or 5, characterized in that the waist (24) is formed as a progressive narrowing of the wall thickness of a neck section (22).
7. Balloon (10), according to any one of claims 1 to 6, characterized in that the outer diameter of the neck (22) varies from 5 mm to 15 mm.
8. Balloon (10), according to any one of claims 1 to 7, characterized in that the head (18) has a diameter ranging from 6 mm to 18 mm in a deflated state.
9. Balloon (10), according to any one of claims 1 to 8, characterized in that the opening at the proximal end has a diameter ranging from 5 mm to 10 mm, such as 8 mm.
10. Balloon (10), according to any one of claims 1 to 9, characterized in that the balloon (10) is formed from silicone.
11. Balloon (10), according to claim 10, characterized in that the balloon (10) is formed from a liquid silicone rubber precursor.
12. Balloon (10), according to any one of claims 1 to 11, characterized in that the body (16) and the head (18) are unitary with each other.
13. Balloon (10), according to any of claims 1 to 12, Petition 870260074140, dated 24 / 07 / 2026, page 15 / 18 3 / 5 characterized in that it is self-supporting so that, in a deflated state, the balloon (10) does not fall on itself.
14. System for expanding a foreskin, characterized in that it comprises: the balloon (10) defined in any one of claims 1 to 13; and an inflation device for inflating the balloon (10).
15. System according to claim 14, characterized in that it further comprises a flow regulator for regulating the flow of fluid into and out of the balloon (10), wherein the flow regulator is used to maintain the balloon (10) in an inflated state.
16. System according to claim 14 or 15, characterized in that it further comprises a connector used to connect the balloon (10) to the inflation device.
17. Kit for expanding a foreskin, characterized in that it comprises: the system defined in any one of claims 14 to 16; and a container housing the system.
18. Mold (100) for forming a balloon (10) characterized in that it is used to expand a foreskin, the balloon (10) comprising a hollow body (16) having a head (18), the body (16) being closed at a distal end and open at a proximal end with a longitudinal axis (36) extending between them, the head (18) extending from the distal end of the body (16), the body (16) defining a neck (22) positioned between the head (18) and the proximal end, a first end of the neck (22) extending from the proximal end of the body (16) to a second remote end of the neck (22), the body (16) having an inner face (34) and an outer face (32) defining a Petition 870260074140, dated 24 / 07 / 2026, page.16 / 18 4 / 5 body wall thickness (16); wherein a neck wall thickness (22) is greater than a head wall thickness (18), a head wall thickness (18) at the distal end is greater than the wall thickness of a remaining head (18), and, in a deflated state, an outer diameter of the head (18) is greater than an outer diameter of the neck (22), such that, when the balloon (10) is inflated, the head (18) expands in a greater radial direction than in a longitudinal axis direction (36) and a diameter of an outer face (32) of the neck (22) remains constant over the length of the neck (22) during inflation, the mold (100) comprising: a projection (114) having a first region (127) to form the body (16) and a second region (118) to form the head (18), the first region (127) having a first diameter and the second region (118) having a second diameter, the first diameter being smaller than the second diameter.
19. Mold (100), according to claim 18, characterized in that the projection (114) further comprises a third region (116) to form a waist (24) in the neck (22), the third region (116) having a third diameter which is larger than the first diameter.
20. Mold (100), according to claim 18 or 19, characterized in that it further comprises a female section (110) for receiving the shoulder (114), the female section (110) having a hole (120) having a constant internal diameter.
21. Mold (100), according to any one of claims 18 to 20, characterized in that the balloon (10) is otherwise defined in any one of claims 1 to 13.
22. Method for forming a balloon (10), characterized in that Petition 870260074140, dated 07 / 24 / 2026, page 17 / 18 5 / 5 the balloon (10) is used to expand a foreskin, the method comprising: providing the mold (100) defined in any of claims 18 to 21, applying a balloon precursor (10) to the mold (100); and curing the balloon precursor (10) to form the balloon (10).
23. Method according to claim 22, characterized in that the balloon precursor (10) is a silicone precursor material that is cured to form a silicone-based balloon (10).
24. Method according to claim 22 or 23, characterized in that it further comprises a post-cure step to further cure the balloon (10).
25. Method, according to any one of claims 22 to 24, characterized in that the balloon (10) is otherwise defined in any one of claims 1 to 13. Petition 870260074140, dated 24 / 07 / 2026, page 18 / 18