MALE EXTERNAL CATHETER

Abstract

A male external catheter includes a tubular body, a flexible flange at the first end of the tubular body surrounding the first opening and including a first side portion and a second side portion, and first and second strap portions including first and second strap ends, respectively. When the first and second strap ends are disconnected, the first and second strap portions do not apply sufficient force to the first and second side portions of the flange, respectively, to deform a shape of the first opening and the first opening has a first width. When the first and second strap ends are connected, the first and second strap portions apply sufficient force to the first and second side portions of the flange, respectively, to deform a shape of the first opening and the first opening has a second width narrower than the first width.

Claims

1. A male external catheter that connects to tubing of a drainage bag, the male external catheter comprising: a tubular body including a first end having a first opening and a second end having a second opening; a flexible flange at the first end of the tubular body surrounding the first opening and including a first side portion and a second side portion on opposing sides of the first opening, wherein the first opening is configured to move between an undeformed configuration and a deformed configuration, the first opening having a first width in the undeformed configuration and a second width in the deformed configuration, the first width being greater than the second width; a first strap portion connected to the first side portion of the flexible flange; and a second strap portion connected to the second side portion of the flexible flange; wherein the first strap portion and the second strap portion are connected to each other and apply a force to the first and second side portions, respectively, of the flexible flange sufficient to maintain the first opening in the deformed configuration.

2. The male external catheter of claim 1, wherein the first and second side portions of the flexible flange include first and second strap openings, respectively, and the first and second strap portions include first and second strap ends, respectively, each configured to extend through the first and second strap openings, respectively, of the first and second side portions, respectively, of the flexible flange.

3. The male external catheter of claim 2, further comprising a strap including the first strap portion, the second strap portion, and a third strap portion, wherein the third strap portion is positioned adjacent the flexible flange around the tubular body.

4. The male external catheter of claim 1, wherein the flexible flange comprises a silicone material.

5. The male external catheter of claim 4, wherein the flexible flange is free from latex.

6. The male external catheter of claim 4, wherein the flexible flange is free from adhesive.

7. The male external catheter of claim 1, wherein the tubular body includes: a base portion adjacent to the flange and having a base wall thickness; a tip portion distal from the flange and including a tip configured to connect to the tubing of the drainage bag, wherein the tip portion has a tip wall thickness; and a central portion between the base portion and the tip portion and having a central wall thickness; wherein the central wall thickness is less than at least one of the base wall thickness and the tip wall thickness.

8. A method of using a male external catheter by a user, the method comprising the steps of: providing the male external catheter comprising: a tubular body including a first end having a first opening and a second end having a second opening; a flexible flange at the first end of the tubular body surrounding the first opening and including on opposing sides of the first opening, wherein the first opening is configured to move between an undeformed configuration and a deformed configuration; a first strap portion connected to the first side portion of the flexible flange; and a second strap portion connected to the second side portion of the flexible flange; wherein, when the first and second strap portions are disconnected from each other, the first opening is biased toward the undeformed configuration having a first width; and wherein, when the first and second strap portions are connected to each other in a position to apply a sufficient force to the first and second side portions of the flexible flange, respectively, the first opening moves into the deformed configuration having a second width narrower than the first width; expanding the first opening of the tubular body; inserting a penis of the user through the first opening and into the tubular body; releasing the first opening of the tubular body such that the first opening is positioned on the penis without the use of adhesive, the first opening being provided in the undeformed configuration having the first width; and pulling the first strap portion and the second strap portion to each other in a position to apply a sufficient force to the first and second side portions of the flexible flange, to cause the first opening to move into the deformed configuration having the second width narrower than the first width in order to secure the first opening snugly on the penis of the user without the use of adhesive; and connecting the first and second strap portions together.

9. The method of claim 8, wherein the first strap portion and the second strap portion are connected below the flexible flange.

10. The method of claim 8, wherein the male external catheter further comprises a strap including the first strap portion and the second strap portion; wherein each of the first and second side portions of the flexible flange includes first and second strap openings, respectively; and wherein the method further comprises the step of positioning the strap through the first and second strap openings.

11. The method of claim 10, wherein the strap further includes a third strap portion positioned around the tubular body on a side opposite of the connected first and second strap portions.

12. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The drawing figures depict one or more implementations in accord with the present concepts, by way of example only, not by way of limitations. In the figures, like reference numerals refer to the same or similar elements.

[0032] FIG. 1 is a perspective view from above of the male external catheter of the present application.

[0033] FIG. 2 is a perspective view from below of the male external catheter of FIG. 1.

[0034] FIG. 3 is a bottom plan view of the male external catheter of FIG. 1

[0035] FIG. 4 is a side elevational view of the male external catheter of FIG. 1.

[0036] FIG. 5 illustrates the male external catheter of FIG. 1 configured for a first method of use featuring a strap extending around the user's waist.

[0037] FIGS. 6A and 6B are a perspective view and a bottom plan view of the male external catheter of FIG. 1, respectively, of the present application, configured for a second method of use featuring disconnected strap ends adjacent to the catheter.

[0038] FIGS. 7A and 7B are a perspective view and a bottom plan view of the male external catheter of FIG. 1, respectively, of the present application configured for a second method of use featuring connected strap ends adjacent to the catheter.

[0039] FIGS. 8A and 8B are bottom plan and side elevational views, respectively, of the male external catheter of FIG. 1, illustrating dimensions.

DETAILED DESCRIPTION

[0040] FIGS. 1-8B illustrate an example of a male external catheter 100 according to the present disclosure. Referring to FIGS. 1 and 2, the male external catheter or condom catheter 100 includes a body 102 having a tubular shape that extends from a flexible flange or base 104. The flange 104 is a body 105 providing a frame or structural support for a first opening 106a at a first end 102a of the body 102 through which the penis extends during use, as shown in FIG. 5. The tubular shape of the body 102 of the male external catheter 100 varies in cross-section along a height H (FIG. 4) thereof. The body 102 also includes a second opening 106b at a second end 102b for connection to tubing of a drainage bag.

[0041] Referring to FIGS. 2 and 3, the opening 106a on the flange 104 of the male external catheter 100 defines an expandable sphincter that changes in size so that the opening 106a may conform to a diameter of a penis of the patient. The expandable sphincter provides a near liquid-tight seal between the male external catheter 100 and the penis so that urine may not easily escape. The expandable nature of the sphincter may also provide a comfortable fit for the patient and reduce the incidence of skin irritation as the body 102 of the condom catheter 100 does not slide or substantially shift when positioned on the penis.

[0042] As shown in FIG. 3, the flange 104 includes first and second side portions 108a, 108b on opposite sides of the opening 106a. Each side portion 108a, 108b has strap opening 110a, 110b for receiving a strap 112, 113 (FIGS. 5-7B). In some embodiments, the strap openings 110a, 110b have a slot shape.

[0043] During one example method of use illustrated in FIG. 5, a strap 112 may be fixedly or removably attached to the strap openings 110a, 110b of the base 104 and extend around the waist of the user to reinforce the positioning of the male external catheter 100 on the patient's body.

[0044] In another example method of use illustrated in FIGS. 6A-7B, a strap 113 may be fixedly or removably attached to the strap openings 110a, 110b of the flange 104 and connected together near the flange 104 so as to apply sufficient force to the first and second side portions 108a, 108b of the flange 104, respectively, to deform a shape of the opening 106a. In this embodiment, the strap 113 includes a first strap portion 113a and a second strap portion 113b connected to the first and second side portions 108a, 108b of the flange 104, respectively. The first and second strap portions 113a, 113b, respectively, include first and second strap ends 113c, 113d.

[0045] Referring to FIGS. 6A and 6B, the first and second strap ends 113c, 113d are initially disconnected such that the first and second strap portions 113a, 113b do not apply sufficient force to the first and second side portions 108a, 108b of the flange 104, respectively. The opening 106a, as a result, is not deformed and defines a first width W.sub.1 of the opening 106a when in an undeformed configuration.

[0046] The opening 106a of the flange 104 of the male external catheter 100 is then stretched open and the penis is then inserted into the stretched, enlarged opening 106a, as described in greater detail below.

[0047] Once the male external catheter 100 is positioned on the user, the first and second strap ends 113c, 113d are connected at a point 115 as shown in FIGS. 7A and 7B such that the first and second strap portions 113a, 113b apply sufficient force to the first and second side portions 108a, 108b of the flange 104, respectively, to deform the shape of the opening 106a. Specifically, the first and second strap ends 113c, 113d connect together and cause the first and second side portions 108a, 108b of the flange 104 to bend towards the body 102 of the catheter 100, causing the opening 106a to move into a deformed configuration seen in FIG. 7B. When the strap ends 113c, 113d are connected, the deformed configuration of the opening 106a has a second width W.sub.2 that is narrower than the first width W.sub.1 of the undeformed configuration.

[0048] In the embodiment illustrated in FIGS. 6A-7B, the strap 113 is threaded through the strap openings 110a, 110b such that a third strap portion 113e between the first and second strap portions 113a, 113b extends below the flange 104 between the side portions 108a, 108b. During use, the third strap portion 113e extends below the flange 104 on a side opposite of the connected strap ends 113c, 113d. The third strap portion 113e provides additional reinforcement to tightly secure the opening 106a about the user's penis to prevent leaks.

[0049] When connecting the first and second strap ends 113c, 113d, the amount of tension needed is minimal in that the goal is to simply bend the side portions 108a, 108b of the flange 104 toward the body 102 of the catheter 100. Connecting the strap ends 113c, 113d too tightly and/or at a point 115 that is too close to the flange 104 may cause excessive deformation to the opening 106a and/or body 102, resulting in discomfort to the user. The amount of tension/force should be at least a minimum amount to cause the side portions 108a, 108b to bend towards the body 102 but less than a maximum amount to avoid excessive deformation and discomfort. Additionally, the first and second strap ends 113c, 113d are connected together below the flange 104 to avoid contact with the skin of the user.

[0050] After the strap ends 113c, 113d are connected, the flange 104 can be separated from the penile skin without much pressure. During use, urine flows from the body 102 through tubing into the drainage bag. A urine column forms between the body 102 of the catheter 100 and the drainage bag, and remains in place due to the negative pressure within the male external catheter 100. The user may briefly separate the flange 104 from the penile skin to allow airflow into the body 102 of the catheter 100, releasing the negative pressure therein and allowing urine within the tubing to drain into the drainage bag. The user can then allow the flange 104 to return to the deformed configuration, snugly fitting around the penis.

[0051] In other embodiments, the first and second strap portions 113a, 113b may be discrete components. Each strap portion 113c, 113d, 113d may be formed integrally with the respective side portion 108 of the flange 104 or may be connected through a hole and peg, an adhesive, or another suitable connection means.

[0052] In some embodiments, the strap 112, 113 may comprise an elastic, non-latex, and/or silicone material. In one example, the strap 113 comprises an elastic, non-latex material having a width of about 0.5 in and a length of about 12 in. In other embodiments, the strap 112, 113 may comprise an inelastic material. In still further embodiments, the strap 113 may comprise an elastic or inelastic material that connects together through a hook and loop fastener, an adhesive, or another suitable means of connection.

[0053] Referring to FIGS. 1 and 2, the body 105 includes a first surface 105a and a second surface 105b opposite the first surface 105a. In the illustrated embodiment, the first surface 105a is contoured to improve comfort and fit during use. The contoured first surface 105a is slightly concave. The body 102 of the male external catheter 100 extends from the second surface 105b, with the tubular shape thereof formed around the opening 106a of the flange 104.

[0054] Referring to FIG. 4, the body 102 includes a base portion 102a, a central portion 102b, and a tip portion 102c. The base portion 102a is adjacent to the base 104 and the tip portion 102c is distal from the base 104. The tip portion 102c is configured to connect to tubing of a drainage bag.

[0055] Each of the base portion 102a, the central portion 102b, and the tip portion 102c include a base wall thickness t.sub.b, a central wall thickness t.sub.c, and a tip wall thickness t.sub.t, respectively. In the illustrated embodiment, the central wall thickness t.sub.c is less than each of the base wall thickness t.sub.b and the tip wall thickness t.sub.t. In some embodiments, the central wall thickness t.sub.c is less than one of the base wall thickness t.sub.b and the tip wall thickness t.sub.t. This difference in wall thicknesses enables the central portion 102b of the body 102 to collapse around the user's penis while urine flows through the tip portion 102c and tip into the drainage bag.

[0056] In some embodiments, the ratio of the central wall thickness t.sub.c to one or both of the base wall thickness t.sub.b and the tip wall thickness t.sub.t is at least 1:1.1, preferably 1:1.2. In other embodiments, the ratio of the central wall thickness t.sub.c to one or both of the base wall thickness t.sub.b and the tip wall thickness t.sub.t is at least 1:1.5, and in still further embodiments, the ratio of the central wall thickness t.sub.c to one or both of the base wall thickness t.sub.b and the tip wall thickness tris at least 1:2.

[0057] The base portion 102a of the body 102 may be formed integrally with the base 104 and has a base height hb of approximately 0.830 in, although the base height hb may vary as desired or required during manufacturing. In one embodiment, the base wall thickness t.sub.b is preferably about 0.060 in at the greatest point, although the base wall thickness t.sub.b may vary as desired or as required during manufacturing. In one embodiment, the base wall thickness t.sub.b tapers from a predominant base wall thickness t.sub.b-p to the central wall thickness t.sub.c near the juncture of the base portion 102a and the central portion 102b. In one embodiment, the predominant base wall thickness t.sub.b-p is about 0.060 in.

[0058] The central portion 102b of the body 102 includes a planar section 102b-1 adjacent the base portion 102a and a bellowed section 102b-2 adjacent the tip portion 102c. The bellowed section 102b-2 includes horizontal bellows 114 transverse to the height H of the body 102, and the planar section 102b-1 may include optional vertical ribbing 116 connected to the horizontal bellows 114. The vertical ribs 116 may be evenly positioned along the perimeter of the body 102 near the juncture of the planar section 102b-1 and the bellowed section 102b-2.

[0059] In one embodiment, the central portion 102b has a central height h.sub.c of about 1.514 in, although the central height h.sub.c may vary as desired or required during manufacturing. The central wall thickness t.sub.c is preferably about 0.030 in, although the central wall thickness t.sub.c may vary as desired or as required during manufacturing.

[0060] The tip portion 102c of the body 102 has a tip height h.sub.t of about 1.315 in, although the tip height h.sub.t may vary as desired or required during manufacturing. The tip wall thickness t.sub.t is preferably about 0.060 in although the tip wall thickness t.sub.t may vary as desired or required during manufacturing. In some embodiments, the tip portion includes horizontal ribbing along the perimeter of the cylindrical body.

[0061] Shown in FIG. 4, the height H of the male external catheter 100 extends from the first surface 105a of the base 104 to a tip end surface 116.

[0062] The male external catheter 100 of the present application may come in different sizes to accommodate differently sized patients. While the dimensions of the structure may vary, the base wall thickness, the central wall thickness, and the tip wall thickness remain the same. In other words, while the diameter of the body may vary between sizes, the central wall thickness is preferably about 0.030 in while the base wall thickness and the tip wall thickness is about 0.060 in.

[0063] In the embodiment illustrated in FIGS. 1-7B, the male external catheter 100 may have the dimensions recited in the following table in reference to FIGS. 6A and 6B for a small-medium size and a medium-large size. It is understood that the dimensions are exemplary only and do not limit the scope of any claims herein, except as may be recited thereby, together with equivalents thereof. The dimensions may vary depending during the manufacturing process or as otherwise desired.

TABLE-US-00001 TABLE 1 Dimensions (in) Small-Medium Size Medium-Large Size FIG. 8A A 2.250 2.250 B 1.737 1.737 C 1.842 1.842 FIG. 8B F 4.280 4.280 G 2.965 2.965 H 1.315 1.315 J 1.514 1.514 K 0.830 0.830 L 0.260 0.160 M 0.100 0.080 N 0.160 0.080 P 4.280 4.280 Q 1.842 1.607 R 0.827 1.062 U 1.003 1.003 V 0.747 0.747 W 0.887 1.122 X 0.947 1.182 Y 0.410 0.410 AA 0.060 0.060 BB 0.030 0.030 CC 0.060 0.060

[0064] In one embodiment, the male external catheter 100 is made of a silicone rubber compound, although other suitable materials may be used. The silicone rubber compound may be a peroxide-cured silicone elastomer including polydimethylsiloxane with vinyl functional groups. In one embodiment, the compound comprises approximately 70% to approximately 90% by weight polydimethylsiloxane. The silicone rubber material may be hardness (Shore A hardness test) of 20 points, a tensile strength of 800 psi, an elongation at rupture of 800%, and a specific gravity of 1.2. In some embodiments, the male external catheter 100 is latex free. In other embodiments, the body 102 and the flange 104 may be composed of the same material or different materials.

[0065] During use of the device as shown in FIG. 5, the patient is placed in a supine position and the elastic strap is positioned under the lower back of the patient. The opening 106a of the flange 104 of the male external catheter 100 is stretched open using index and middle fingers. The height H of the male external catheter 100 is compressed, using thumbs to push the tip portion 102c of the body 102 toward the base 104. The penis is then inserted into the stretched, enlarged opening 106a, and the base portion 102a of the body 102 is pulled and pushed over and above the glans penis towards the base of the penis as far as possible.

[0066] A first end of the elastic strap 112 is extended from a first side of the patient across the lower abdomen and secured to the side portion 108 opposite the first side of the patient. A second end of the elastic strap 112 is then extended from a second side of the patient across the lower abdomen and secured to the side portion 108 opposite the second side of the patient.

[0067] Referring to use of the device as shown in FIGS. 6A-7B, the patient is placed in a supine position. The opening 106a of the base 104 of the male external catheter 100 is stretched open using index and middle fingers. The height H of the male external catheter 100 is compressed, using thumbs to push the tip portion 102c of the body 102 toward the base 104. The penis is then inserted into the stretched, enlarged opening 106a, and the base portion 102a of the body 102 is pulled and pushed over and above the glans penis towards the base of the penis as far as possible.

[0068] The first end 113c and the second end 113d of the strap 113 are drawn together in front of the body 102 below the flange 104 and tied such that sufficient force is applied to the first and second side portions 108a, 108b of the flange 104, respectively, to deform a shape of the opening 106a.

[0069] In particular, the deformation of the opening 106a from the first width W.sub.1 to the second width W.sub.2 combined with the variation in wall thickness of the body 102 provides a male external catheter that maintains positioning on the user's penis with minimal to no leakage and without undue pressure on the penis during use. Use of the external male catheter 100 as shown in FIGS. 6A-7B eliminates the use of a strap around the body as shown in FIG. 5 as well as the use of adhesives, foam straps, or additional straps that often lead to slippage, frequency changes, and skin erosion and damage.

[0070] Further, a negative pressure exists within the body 102 of the male external catheter 100 is being used to drain urine to the drainage bag such that urine remains in the tubing between the male external catheter 100 and the drainage back. A tool, a finger, or another object may be used to separate the flange 104 from the penis of the user during use to release the negative pressure. This release of negative pressure allows the urine to flow freely through the tubing to the drainage bag, away from the male external catheter 100.

[0071] It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. For example, various embodiments of the systems and methods may be provided based on various combinations of the features and functions from the subject matter provided herein