Patent ID: 12226339

DETAILED DESCRIPTION

While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described one or more embodiments with the understanding that the present disclosure is to be considered illustrative only and is not intended to limit the disclosure to any specific embodiment described or illustrated.

Referring toFIG.1, an ostomy collection and drainage system5includes an ostomy pouch10having an outer wall12defining an internal volume to form an internal collection area (not shown). The outer wall12may have an inlet opening14formed therein. The inlet opening14is disposed in fluid communication with the internal collection area and is configured to receive a stoma so that a discharge from the stoma may be received in the internal collection area and stored in the internal collection area as contents of the ostomy pouch10. The inlet opening14may be positioned at an upper portion of the ostomy pouch10.

An outlet body20is secured to the outer wall12. In one embodiment, the outlet body20is positioned at a lower portion of the ostomy pouch10and is configured to selectively allow drainage of the contents from the internal collection area, to seal against drainage of the contents from the internal collection area, and to connect to a high volume drainage system, such as a night drainage system, described further below. In one embodiment, the outlet body20may be secured to the outer wall12for example, by heat sealing, with an adhesive, or by being formed together with the outer wall12, for example in a molding process, such as a two-shot molding process. Preferably, the outlet body20is secured to the outer wall12in such a way that a seal is formed between the outlet body20and the outer wall12, to prevent or limit undesired leakage of the contents between the outer wall12and the outlet body20.

The ostomy collection and drainage system5further includes a closure40and an adapter60, each configured for removable and interchangeable coupling to the outlet body20. In one embodiment, the closure40and the adapter60are interchangeably coupled to the outlet body20such that in a first condition the adapter60is coupled to the outlet body20and in a second condition the closure40is coupled to the outlet body20. In one embodiment, the closure40and the adapter60may be interchangeably coupled to the outlet body20by way of a latch engaging a catch in friction or interference fit, including a snap fit, and optionally, a mechanical interlock to restrict movement of the closure40or adapter60relative to the outlet body20, for example, in an axial or substantially axial direction D1. A tube80may be connected to the adapter60to fluidically connect the ostomy pouch10to, for example, a night drainage bag (not shown).

FIG.2is a bottom perspective view of an outlet body120configured for connection to an ostomy pouch10in an ostomy collection and drainage system, according to an embodiment described herein.FIG.3is a front view of the outlet body120ofFIG.2. Referring toFIGS.2and3, the outlet body120generally includes an outlet opening122through which contents of the ostomy pouch10may be drained. The outlet opening122, in one embodiment, extends along a first axis A1. In one embodiment, the outlet opening122may have a width or diameter W of about 15 mm to about 25 mm. For example, in one embodiment, the outlet opening122may have a width or diameter W of about 16 mm to about 19 mm.

FIG.4is another side view of the outlet body120ofFIG.2. With reference toFIGS.2-4, the outlet body120includes one of a latch and a catch, which are configured for releasable engagement with one another as described further below. In one embodiment, the catch124is formed on the outlet body120. The catch124may be formed as a projection which extends radially outward and in a peripheral direction along at least a portion of a periphery on the outlet body120. In one embodiment, the outlet body120includes two catches124similarly formed and spaced apart from one another by a gap126in the peripheral direction.

In one embodiment, the catch124includes a first surface128which may be an upper surface of the catch124. It is understood however, that the directional term “upper” does not limit the outlet body120and the catch124to a particular orientation, but rather, is used only as example consistent with the orientation of the outlet body120and catch124as shown in the drawings. In one embodiment, the catch124includes at least one peak130formed as a section of increased height extending upwardly on the first surface128. In one embodiment, the catch124includes two peaks130spaced apart in the peripheral direction on the outlet body120.

As more clearly shown inFIGS.2and3, a closure140is configured for removable coupling to the outlet body120. For example, the closure140may be removably coupled to the outlet body120by way of a frictional engagement with the outlet body120in the outlet opening122. In one embodiment, the closure140includes a plug142having an outer surface configured to frictionally engage an inner surface131around the outlet opening122. Preferably, the frictional engagement between the plug140and the inner surface131is a sealed engagement to substantially prevent or limit unintended egress of the contents through the outlet opening122. In one embodiment, the plug142may include one or more ribs144. The one or more ribs144may extend either partially or entirely about an outer periphery on the plug140.

Referring still toFIGS.2and3, the closure140may also include a cap146configured, in one embodiment, to engage an axial end132of the outlet body120when the plug142is engaged in the outlet opening122, i.e., in the second condition. The cap146may be formed having a width greater than a width of the plug142. In one embodiment, the cap146and the plug142are formed as a single, continuous unit. Further still, in one embodiment, the closure140may be connected to the outlet body120with a flexible member150, such as a strap or living hinge.

Accordingly, in the embodiments shown inFIGS.2-4, the closure140may be coupled to the outlet body120by positioning the plug142in the outlet opening122in frictional engagement with the inner surface131. With the closure140so positioned, the ostomy pouch10is configured to collect and store discharge from a stoma. With the closure140removed from the outlet opening142, the contents (i.e., the stoma discharge) may be drained from the ostomy pouch10through the outlet opening122.

FIG.5is a front perspective view of an adapter160according to an embodiment described herein. The adapter160includes an adapter opening162extending therethrough. In one embodiment, the adapter opening162extends on a second axis A2.

The adapter160includes the other of the latch and the catch that is formed on the outlet body120. For example, in one embodiment, the adapter160includes a latch164configured to releasably engage the catch124. In one embodiment, the adapter160may include two or more latches164. In one embodiment, the number of latches164is equal to the number of catches124, but the present disclosure is not limited to such an embodiment. In addition, it is understood that in another embodiment the outlet body120may be formed with the latch164and the adapter160may be formed with the catch124.

The latch164and the catch124are configured for releasable engagement with one another by way of a friction or interference fit, including a snap fit, to couple the adapter60and outlet body120together. In addition, the latch164and the catch124may form a mechanical interlock to resist movement in, or substantially in, the axial direction D1of the adapter160relative to the outlet body120. In one embodiment, the latch164and the catch124may be brought into engagement by way of rotational movement relative to one another. In one embodiment, the relative rotational movement brings the latch164and catch124into a position where the mechanical interlock is formed, and the adapter160is coupled to the outlet body120.

In one embodiment, the latch164includes a first portion166extending generally in the axial direction D1. The latch164may also include a second portion168, formed as an inward projection, such as a hook, at a free end of the first portion166.

Referring still toFIG.5, the adapter160includes a first collar170and a second collar172. In one embodiment, the first collar170is configured to frictionally engage the outlet body120, for example, within the outlet opening122. Preferably, the frictional engagement of the first collar170within the outlet opening122is a sealed engagement. The first collar170may include a peripherally extending bead174configured for engagement with the inner surface131to form a localized section of increased pressure against the inner surface131.

FIG.6is a perspective view of the adapter160coupled to the outlet body120, according to an embodiment. Referring toFIG.6, the adapter160may be coupled to the outlet body120by way of releasable engagement between the latch164and the catch124, with the closure140removed from the outlet opening122. In one embodiment, the adapter opening162and the outlet opening122may be axially aligned and extend on a common axis A3through the coupled assembly adapter160and the outlet body120.

The adapter160may be coupled to the outlet body120by moving the adapter160toward the outlet body120, for example in the axial direction D1, to bring the first collar170into frictional engagement with the outlet body120within the outlet opening122. The latch164may be moved, for example, in the axial direction D1in the gap126. The adapter160may be rotated to bring the latch164into interfering contact with one of the peaks130of the catch124, thereby increasing resistance to the rotational movement. Continued rotational movement causes the latch164to deflect as it interferingly moves past the peak130, and return to its relatively un-deflected condition upon clearing the peak130. That is, rotation of the latch164past the peak130of the catch124brings the latch164and the catch124into an interference or snap fit engagement. The second portion168of the latch164, formed as an inward projection, engages the first surface128of the catch124to form a mechanical interlock to resist movement in the axial direction D1of the adapter160away from the outlet body120.

In one embodiment, movement of the latch164into engagement with the catch124, or vice versa, may provide an audible and/or tactile feedback to the user, in the form of a “click,” “pop” or the like, which may be heard and/or felt by the user. Visual feedback may be provided to the user by way of visually inspecting the position of the latch164relative to the catch124, for example, by determining that the latch164is positioned between the peaks130. Accordingly, a user can confirm that the adapter160is coupled to the outlet body120by one or more of an audible, tactile, or visual confirmation.

To remove the adapter160from the outlet body120, the adapter160may be rotated relative to the outlet body120to disengage the latch164from the catch124. During disengagement, the latch164interfering moves past one of the peaks130in a manner similar to that described above. With the latch164positioned in the gap126, the adapter160may be moved away from the outlet body120, the first collar170may be removed from frictional engagement in the outlet opening122, and the adapter160may be removed from the outlet body120. Audible, tactile and or visual feedback may be provided to the user when removing the adapter in response to the interfering movement of the latch164out of the catch124.

FIG.7is a top view of the outlet body120coupled to the adapter160, which corresponds to the first condition. Referring toFIG.7, in one embodiment, the adapter opening162and the outlet opening122may co-extend on a common axis A3(shown inFIG.6).

FIG.8shows a drainage tube180connected to the adapter160. In one embodiment, the second collar172(seeFIGS.5and6) may be positioned in the drainage tube180and frictionally engage the tube180. Preferably, the frictional engagement is a sealed engagement. Alternatively, the adapter160and drainage tube180may be connected using other suitable techniques, such as heat sealing, adhesive fastening or mechanical fastening.

Referring toFIGS.5,6and8, for example, the adapter160may further include a gripping collar176positioned axially between the first collar170and the second collar172. The gripping collar176is configured to be gripped by a user to manipulate the adapter160for example, for rotational and/or axial movement. In one embodiment, the latch164may extend from the gripping collar176. The gripping collar176may have an outer width that is greater than an outer width of the first collar170and the second collar172.

FIGS.9-11illustrate an outlet body220having a closure240according to another embodiment described herein. The outlet body220may be formed substantially the same as the outlet body120described above. Accordingly, further description of like parts of the outlet body220and the outlet body120may be omitted below.

FIG.9is a perspective view showing the closure240frictionally engaged in the outlet opening222of the outlet body220,FIG.10is a front view showing the closure240frictionally engaged in the outlet opening222of the outlet body220, andFIG.11is a front transparent view showing the closure240frictionally engaged in the outlet opening222of the outlet body220, according to embodiments described herein.

ReferringFIGS.9-11, the closure240may be a two-part closure. For example, the closure240may include a first plug portion242(seeFIG.11) configured to be removably positioned and frictionally engaged in the outlet opening222. In one embodiment, the first plug portion242may include one or more ribs244formed on an outer surface, configured to frictionally engage the inner surface231of the outlet body220. The two-part closure240may also include a first cap246configured to engage an axial end232of the outlet body220when the first plug portion242is disposed in the outlet opening222. The first cap246has a width that is greater than a width of the first plug portion242. In one embodiment, the first plug portion242and the first cap246are formed as a single, continuous piece.

Still referring to theFIGS.9-11, the two-part closure240may also include a second plug portion342, optionally formed with one or more ribs344on an outer surface, and a second cap346. The second cap346may have a width that is greater than a width of the second plug portion342. As more clearly shown inFIG.11, the first plug portion242and the first cap246include a closure opening322extending therethrough. With the first plug portion242positioned in the outlet opening222, the closure opening322is disposed in communication with the outlet opening222and may receive the contents ostomy pouch10to drain the contents through the closure opening322.

The second plug portion342is configured for removable positioning and frictional engagement in the closure opening322. In addition, the second cap346is configured to engage an axial end332of the first cap246. In one embodiment, the first cap246is formed with a recess or seat configured to receive at least a portion of the second cap346. Preferably the frictional engagement between the first plug portion242and the inner surface231of the outlet body220, and the frictional engagement between the second plug portion342and the inner surface331of the first plug portion242are sealed engagements.

In the embodiments shown inFIGS.9-11, with the first and second plug portions242,342positioned in the outlet opening222and the closure opening322, respectively, the outlet body220may be substantially closed and sealed against egress of the contents from the ostomy pouch10. Accordingly, the ostomy pouch10may collect and store the discharge from the stoma. One or both of the first and second plug portions242,342may be removed from the outlet opening222, or closure opening322, respectively, to drain the contents from the ostomy pouch10.

In one embodiment, the first plug portion242and the first cap246may be connected to the outlet body220by a first flexible member250, such as a strap or a living hinge. The second plug portion342and the second cap346may be connected to the first plug portion242and the first cap246with a second flexible member350, such as a second strap or second living hinge. In one embodiment, the closure member240may be formed as a single, continuous unit, for example, in a molding process.

FIGS.12-14show the outlet body220and closure240together with an adapter260and drainage tube280, according to an embodiment described herein. In one embodiment, the adapter260is formed the same as the adapter160described above. Accordingly, further description of like parts in the adapter260and the adapter160may be omitted below.

FIG.12is a top perspective view of an assembly formed by the outlet body220, closure240, adapter260and drainage tube280, according to an embodiment, and used in an ostomy collection and drainage system.FIG.13is a front view of the assembly shown inFIG.12, andFIG.14is a transparent view of the assembly shown inFIG.12, according to an embodiment. Referring toFIGS.12-14, the closure240may be removed from frictional engagement with the outlet body220so that the contents of the ostomy pouch10may be drained through the outlet opening222. The adapter260may be removably coupled to the outlet body220in the manner described above with respect to the adapter160and outlet body120. That is, in one embodiment, the adapter260may be coupled to the outlet body220by way of engagement between the latch264and the catch224. The resulting mechanical interlock between the latch264and the catch224resists relative axial movement. Frictional engagement of the first collar270in the outlet opening222also resists relative axial movement and preferably forms a sealed connection. Further, the second collar272may be frictionally engaged with the drainage tube280.

Accordingly, in the embodiments shown inFIGS.12-14, the contents of the ostomy pouch10may be drained through the outlet opening222of the outlet body220, the adapter opening262of the adapter260and into the tube280. The tube280, at an end opposite to the adapter260, may be coupled to a high volume bag, such as a night drainage bag (not shown).

FIGS.15-17show the outlet body220and closure240together with an adapter360and a tube380, according to another embodiment described herein.FIG.15is a top perspective view of an assembly formed by the outlet body220, closure240, adapter360and tube380, according to an embodiment.FIG.16is a front view of the assembly shown inFIG.15, andFIG.17is a transparent view of the assembly shown inFIG.15, according to an embodiment.

Referring toFIGS.15-17, the closure240may be removed from frictional engagement with the outlet body220so that the contents of the ostomy pouch10may be drained through the outlet opening222. The adapter360may be removably coupled to the outlet body220in the manner described above with respect to the adapter160and outlet body120. That is, in one embodiment, the adapter360may be coupled to the outlet body220by way of engagement between the latch364and the catch224, and frictional engagement of the first collar370in the outlet opening222. Further, the second collar372may be connected with the tube380for example, in frictional engagement, by way of heat sealing, using an adhesive or mechanical fastener, or combinations thereof.

However, in the embodiments shown inFIGS.15-17, the second collar372and tube380are sized and shaped for use in conjunction with a Foley catheter. For example, each of the second collar372and the tube380have a width, or diameter, that is less than a width, or diameter, of the second collar272and tube280in the embodiments above and shown inFIGS.12-14. In addition, with reference toFIG.16, for example, the second collar372may be formed having one or more sections of variable outer widths, or diameters. For example, each section may have a decreasing width from a first end to a second end.

FIGS.18-20show front, side and bottom perspective views, respectively, of an outlet body420and closure440according to another embodiment described herein. Referring toFIGS.18-20, the outlet body420is configured for connection to the ostomy pouch10in the manner described above with respect to the outlet body120. The outlet body420includes an outlet opening422configured to receive and allow draining of the contents from the ostomy pouch10. The outlet opening422is defined at least in part by the inner surface431of the outlet body420. In one embodiment, the outlet body420is formed with a catch424configured for removable engagement with a latch, as described further below. In one embodiment, the outlet body420includes two catches424. In one embodiment, the outlet opening422may have a width or diameter W of 15 mm to 25 mm. For example, in one embodiment, the outlet opening422may have a width or diameter W of 16 mm to 19 mm.

FIGS.21-23are enlarged views showing different perspectives of the catch424, according to an embodiment. Referring toFIGS.18-23, the catch424is generally formed as a recess at or near an axial end426of the outlet body420, and includes a first portion428open to the axial end426and a second portion430spaced from the axial end426. In one embodiment, the second portion430may be spaced from the axial end426by an arm432. A guide surface434may be formed along a portion of catch424. The catch424may also include a protrusion436. In one embodiment, the protrusion436is disposed in the second portion430.

In one embodiment, the outlet body420may include an alignment edge438on an outer surface. The alignment edge438may define, for example, a line or curve, and may be formed as an angled or rounded corner, a channel or other external structural feature and/or visible marking. In one embodiment, the alignment edge438may extend substantially in the axial direction D1. The alignment edge438may include a first section extending on the outlet body, and a second section extending on the arm432, aligned with the first section. In one embodiment, the protrusion436may be aligned with the alignment edge438as well.

FIGS.24-26are perspective views of an adapter460configured for removable coupling with the outlet body420and connection to a drainage tube480, according to an embodiment. Referring toFIGS.24-26, the adapter460includes an adapter opening461extending therethrough, a first inner collar462around a portion of the adapter opening461, and a first latch464having a first base466and a first lug468. A first notch470may be formed on the first latch464, for example on the first lug468. The adapter460also includes a first axial face472and a first groove473formed between the first axial face472and the first lug468. The adapter460may also include an adapter guide surface474and an adapter alignment edge476. Further, a first radial gap478may be formed between an outer surface of the first inner collar462and an inner surface of the first latch464. In one embodiment, the adapter460includes two first latches464which may be similarly formed.

FIG.27is an enlarged bottom view of the closure440andFIG.28is a bottom perspective view of the closure440, according to an embodiment described herein. In one embodiment, the closure440may be substantially identical to the adapter460, except that the closure440does not include an opening through which the contents of the ostomy pouch10may flow. That is, the closure440does not have a part which corresponds to the adapter opening461.

Accordingly, in one embodiment, and with reference toFIGS.18,20,27and28, the closure440includes a second inner collar442and a second latch444having a second base446and a second lug448. A second notch450may be formed on an inner surface of the second latch444, for example on the second lug448. The second lug448is spaced from a second axial face452by a second groove453. The second latch444may also include a closure guide surface454. The closure440may also include a closure alignment edge456on an exterior surface of the closure440. The closure alignment edge456may be formed substantially the same as the alignment edge436of the outlet body420. The second inner collar442and the second latch444are spaced apart by a second radial gap458. In one embodiment, a portion of the outlet body420may be received in the second radial gap458when the closure440is coupled to the outlet body.

In one embodiment, the second inner collar442, the second latch444, the second base446, the second lug448, the second notch450, the second axial face452, the second groove453, the closure guide surface454, the closure alignment edge456and the second radial gap458of the closure440correspond, respectively, to the first inner collar462, the first latch464, the first base466, the first lug468, the first notch470, the first axial face472, the first groove473, the adapter guide surface474, the adapter alignment edge476and the first radial gap478of the adapter460. That is, the parts of the closure440described above may be formed having substantially the same size, shape and relative positioning, for example, as the corresponding parts on the adapter460. Accordingly, the adapter460and the closure440may be interchangeably coupled to the outlet body by engagement of the first latch464or second latch444to the catch424.

FIGS.29-37show different views of the adapter460coupled to the outlet body420according to an embodiment. Referring generally toFIGS.29-37, the adapter460may be coupled to the outlet body420by moving the first latch464into engagement with the catch424. For example, the latch464may be moved into a friction or interference fit engagement with the catch424, and also form a mechanical interlock to restrict axial movement of the adapter460relative to the outlet body420.

In one embodiment, the adapter460may be moved toward the outlet body420, in the axial direction D1for example, to position the first base466in the first portion428of the catch424. The respective guide surfaces434,474may be moved into contact with another, and such contact may cause rotation of the adapter460relative to the outlet body420. Alternatively, the user may manually rotate the adapter460relative to the out body420.

Movement of the adapter460toward the outlet body420positions the first inner collar462is in the outlet opening422. In addition, the first lug468is clear of the arm432and moved past the arm432. Rotation of the adapter460, referred to above, causes first lug468to move into the second portion430of the catch424. The first notch470is configured to engage the protrusion436in a friction or interference fit. In addition, the arm432is received in the first groove473to form the mechanical interlock. The adapter460may be coupled to the outlet body420in the first condition.

The adapter460may be removed from the outlet body420by rotating the adapter460relative to the outlet body420, or vice versa, to disengage the first notch470from the protrusion436. Accordingly, the first lug468may be moved out of the second portion430and out of the mechanical interlock with the arm432. The adapter460may then be moved away from the outlet body420, for example in the axial direction D1, and the first collar462may be removed from the outlet opening422.

In the embodiments above, an audible, tactile and/or visual feedback may be provided to the user to confirm coupling of the adapter460to the outlet body420by way of engagement of the first latch464and the catch424. For example, in one embodiment, the first notch470and the protrusion436may be brought into a friction or interference fit to provide an audible or tactile “click,” “pop,” or the like which may be heard or felt by the user. Visual feedback and confirmation may be provided by aligning of the alignment edge438and the adapter alignment edge476. Conversely, similar feedback may be provided to the user when removing the adapter460from the outlet body420, in response to disengagement of the first notch470from the protrusion436, and respective alignment edges438,476being moved out of alignment with one another.

In one embodiment, the closure440may be coupled, interchangeably with the adapter460, to the outlet body420, by way of engagement between the second latch444and the catch424. As detailed above, the closure440is formed similarly to the adapter460, except that the closure is closed (i.e., does not have an opening extending therethrough) to prevent or limit egress of the contents from the pouch through the outlet opening422. Accordingly, the closure440may be coupled to the outlet body420in substantially the same manner as the adapter460described above.

For example, in one embodiment, the closure440is moved toward the outlet body420to position the second inner collar442in the outlet opening422and the second base446in the first portion428of the catch424. The closure440may be rotated, for example, by way of continued movement toward the outlet body420and contact between the respective guide surfaces434,454, or by manual rotation. Rotation of the closure440moves the second lug448into the second portion430of the catch424. The second notch450may engage the protrusion436in a friction or interference fit and provide audible and/or tactile feedback in response to such engagement. The second lug448also forms a mechanical interlock with the arm432received in the second groove453to restrict movement of the closure440away from the outlet body420when coupled to the outlet body420. Visual confirmation of coupling between the closure440and the outlet body420may be provided by alignment of the respective alignment edges438,456on the outlet body420and the closure440, respectively.

Referring to the transparent views shown inFIGS.35and36, the drainage tube480may be coupled to the adapter460to connect the ostomy pouch10, outlet body420and adapter460to a high-volume collection pouch, such as a night drainage bag (not shown). The tube480may be connected to the adapter460, for example, by friction fit, heat sealing, adhesive, a mechanical fastener, combinations thereof or other suitable techniques.

FIG.37is a top perspective view of the outlet body420coupled to drainage tube480via the adapter460. As shown inFIG.37, the outlet opening422is disposed in communication with the adapter opening461and the drainage tube480to allow for flow of the contents from the ostomy pouch10through the outlet body420, adapter460and drainage tube480, for example, to a high-volume collection pouch.

Referring again toFIG.1, the closure40is removably coupled to the outlet body20to selectively open and close the outlet body20, and in turn, the ostomy pouch10. With the closure40coupled to the outlet body20(i.e., the second condition) the outlet body20and ostomy pouch10are in a closed condition such that the ostomy pouch10may collect and store stoma discharge as contents within the internal collection area, and unintended egress of the contents is substantially prevented or limited by way of the closure40. The closure40may be removed from the outlet body20to allow for emptying or drainage of the ostomy pouch10through an outlet body20.

The closure40and adapter60may be interchangeably coupled to outlet body20. Thus, adapter60may be removably coupled to the outlet body20when the closure40is not coupled to the outlet body20. The adapter60may be connected to the drainage tube80to allow for drainage of the contents of the ostomy pouch10through the outlet body20, adapter60and drainage tube80to, for example, a high-volume collection pouch, such as a night drainage bag.

FIGS.38-44further illustrate the outlet body20, closure40, adapter60and drainage tube80shown inFIG.1.FIG.39is a perspective view of the adapter60. The adapter60may include an adapter opening62and a first latch64. In one embodiment, the first latch64is generally formed as a recess having a first shoulder68therein. The recess may be open at a top surface of the adapter60and a second surface, adjacent to the top surface and extending at an angle relative to the top surface so as to intersect a direction of rotation of the adapter60when coupling the adapter60to the outlet body20. The adapter60also includes an adapter alignment edge68.

FIG.40is a perspective view of the outlet body20, according to an embodiment. The outlet body20includes, for example, an outlet opening22, through which the contents of the ostomy pouch10may be drained. The outlet body20also includes a catch24. In one embodiment, the outlet body20may include two catches24. The catch24may have a foot26at a free end thereof. The outlet body20also includes an alignment edge28.

FIG.41is a top view of the closure40, according to an embodiment. The closure40may be formed substantially the same as the adapter60, except that the closure40is formed with a plug42and cap46instead of an adapter opening62extending therethrough. Accordingly, the closure40may be coupled to the outlet body20to substantially prevent or limit egress of the contents from the ostomy pouch10through the outlet body20. In one embodiment, the closure40includes a second latch44formed as a recess having a second shoulder48. The closure40may also include a closure alignment edge50. In one embodiment, the closure40includes two second latches44. In one embodiment, the second latch44and shoulder48may be configured substantially the same as the first latch64and first shoulder66, respectively. In one embodiment, the plug42is configured to frictionally engage the outlet body20within the outlet opening22. Preferably, the frictional engagement between the plug42and the outlet body20is a sealing engagement.

In one embodiment, the second latch44and the second shoulder48may be formed having substantially the same, or the same size, shape and relative position on the closure40as the first latch64and the first shoulder66on the adapter60. Accordingly, the closure40is configured for removable coupling to the outlet body20in substantially the same manner as the adapter60, as described further below.

FIG.42is an exploded view of the closure40and the outlet body20ofFIG.1, andFIG.43shows the closure40coupled to the outlet body20. Referring toFIGS.42and43, to couple the closure40to the outlet body20, the second latch44is held at a position rotationally offset from the catch24with the plug42generally aligned with the outlet opening22. The closure40may then be moved toward to the outlet body20, or vice versa, for example in the axial direction D1, such that the plug42is received in the outlet opening22. The closure40may be rotated relative to the outlet body20to move the second latch44into engagement with the catch24. In one embodiment, the second latch44and the catch24engage one another. For example, the second shoulder48may engage the foot26in a friction or interference fit. The foot26and shoulder48may be sized and shaped such that an audible and/or tactile “click,” “pop” or the like may be provided when the closure40is coupled to the outlet body20in response to the engagement of the second latch44and the catch24.

Further, in one embodiment, visual confirmation of coupling may be provided by alignment of the alignment edge28of the outlet body20and the closure alignment edge50of the closure40.

To remove the closure40from the outlet body20, the closure40may be rotated in an opposite direction to that above, such that the second latch44is moved outward from the catch24. Disengagement of the second latch44from the catch24, for example, disengagement of the second shoulder48and foot26, may provide an audible and/or tactile “click,” “pop” or the like. In addition, the rotation may move the alignment edge28out of alignment with the closure alignment edge50, thereby providing visual confirmation that the closure40is no longer coupled to the outlet body20. The closure40may then be moved away from the outlet body20, for example in the axial direction D1, to remove the plug42from the outlet opening22.

FIG.43is a perspective view showing the adapter60and drainage tube80positioned relative to the outlet body20, with the closure40coupled to the outlet body. The closure40may be removed from the outlet body20in the manner discussed above. The adapter60may then be coupled to the outlet body20.

Accordingly, in the embodiments above, a frictional engagement or interference fit between the latch or the second latch and the catch allows for additional security and retention when the adapter or closure is coupled to the outlet body. For example, the adapter or the closure may have increased resistance to rotation out of a coupled condition due to the engagement of that latch or the second latch and the catch. In addition, the engagement of the latch or the second latch and the catch may form a mechanical interlock which resists movement of the adapter or the closure away from the outlet body, for example, in a substantially axial direction. Thus, the closure and adapter may be less susceptible to inadvertent removal from outlet body.

In addition, engagement of the latch or the second latch and the tab may provide audible and/or tactile feedback to the user to confirm that the adapter or closure is properly coupled to the outlet body, such that the adapter or closure is less susceptible to inadvertent removal from the outlet body. Conversely, audible and/or tactile feedback may be provided to the user when the latch or the second latch and the tab become disengaged. Further, the outlet body, the adapter and/or the closure may include external structural features which are moved into alignment with one another when the adapter or closure are properly coupled to the outlet body, thereby providing visual feedback of proper coupling. Conversely, the structural features may be moved out of align member when the adapter or closure is moved from the proper coupling position.

Although only referred to and discussed with reference to the embodiments shown inFIGS.2and20, it is understood that the outlet opening of the various embodiments above may have a width or diameter W of 15 mm-25 mm. For example, in one embodiment, the outlet opening may have a width or diameter W of 16 mm-19 mm.

Referring toFIGS.45-50, an outlet body520with a closure540tethered thereto according to an embodiment is shown.FIG.45is a perspective view showing the outlet body520attached to an ostomy pouch500and an adapter560coupled to the outlet body520. The ostomy pouch500is connected to a night drainage bag590via a drainage tube580, which is attached to the adapter560at one end and to the night drainage bag590at the other end. The outlet body520and the adapter560may be formed substantially the same as the outlet body120and the adapter160described above. Accordingly, further description of like parts of the outlet body520and the outlet body120and like parts of the adapter560and the adapter160may be omitted below.

In this embodiment, the outlet body520may include a docking system configured to hold the closure540in place when the closure540is not engaged in an outlet opening522of the outlet body520. The docking system may be configured to dock the closure540at a fixed place away from the outlet opening522, such that the closure540does not interfere with draining of body waste collected in the ostomy pouch500through the outlet opening522.

FIGS.46-49are various views of the outlet body520comprising the docking system including a first docking part502and a second docking part504according to an embodiment. In this embodiment, the first docking part502may be provided on the outlet body520. The first docking part502may be formed as a handle like projection, which extends generally radially outward from the outlet body520to provide an opening506for receiving the second docking part504. The second docking part504may be provided on a flexible member550, which connects the closure540to the outlet body520. The second docking part504may be configured as a tab like projection extending from a side surface of the flexible member550. To dock the closure540, a user may grab the closure540and manipulate the flexible member550to insert the second docking part504into the opening506defined in the first docking part502. The first and second docking parts502,504may be configured to fixedly hold the closure540away from the outlet opening522.

In other embodiments, the first and second parts of the docking system may be provided in various different forms, wherein the first and second docking parts are configured to engage with each other to dock the closure540proximate the outlet body520away from the outlet opening522. For example, the first and second docking parts may be provided as hook and loop fasteners, latch and catch, or other known mechanical or adhesive coupling systems.

Any patents referred to herein, are hereby incorporated herein in their entirety, by reference, whether or not specifically indicated as such within the text of this disclosure. Various features of the embodiments above may be used together with or replace other features of different embodiments above.

In the present disclosure, the words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.