The present disclosure relates to ostomy appliances, and more particularly to a convex ring member for use with ostomy appliances for providing localized and customized convex support around a stoma.
Ostomy pouches for the collection of body waste output from a stoma are well known and used by individuals who have had surgery such as a colostomy, ileostomy or urostomy. Ostomy pouches are generally attached to a user via an ostomy barrier, which is configured to seal against peristomal skin surfaces and protect the peristomal surfaces from exposure to stomal effluent. However, the topography of stomas and peristomal surfaces surrounding stomas can vary among patients and providing a single ostomy appliance which can effectively seal against such different peristomal surfaces and stomas can be particularly challenging. For example, a stoma may protrude more or less, or may even be flush or recessed.
A person with an ostomy having a stoma that is flush or recessed may find that applying external support or pressure from a barrier in the peristomal region aids in directing the discharge of effluent from the stoma directly into the ostomy pouch which can prevent undesirable leakage of body waste output between the barrier and the pouch. Accordingly, the effectiveness of an adhesive seal between the ostomy barrier and the peristomal skin surface (i.e., a seal formed by the adhesive layer) may be prolonged. Thus, convex inserts and convex ostomy barriers, such as ADAPT® convex barrier rings available through the assignee of the present application, have been developed to apply pressure around such peristomal regions.
However, the convexity of a conventional convex ostomy barrier or insert is fixed and may not work efficiently for all ostomates. Thus, convex ostomy barriers and convex inserts of various convexity depths have been made available in the market. Further, an ostomate may wish to incrementally adjust the convexity of an ostomy barrier to achieve an optimal convexity for his/her topography of stoma.
Accordingly, for at least the above-noted reasons, there is a critical need in the art for a customizable ostomy appliance that can accommodate a variety of stomal features and provide a desired degree of convex support to particular localized regions around the stoma inlet/opening. There is further a desire to provide a customizable ostomy appliance that can provide varying degrees of support around the stoma inlet/opening and that can enable a user to adjust or set the amount of flexibility or rigidity to different support regions. There is further a need in the art for an ostomy appliance that can provide the necessary flexibility upon application without compromising the structural rigidity as a support when in use.
Embodiments presented herein are directed to an ostomy appliance comprising a ring member and a rib member. The ring member can have an interior surface and an engagement portion encircling a centrally-located input opening. The engagement portion can comprise a plurality of spaced-apart flexible tabs extending radially inward into the input opening. The flexible tabs can have opposing side edges and opposing interior and exterior surfaces with an opening extending therebetween. The opening can be centrally located between the opposing side edges. A plurality of spaced-apart teeth can extend radially inward from the inside surface of the ring member into the input opening. The teeth can be in alignment in a first direction with spaces between the plurality of flexible tabs and can have an inside surface facing the interior surface of the plurality of flexible tabs.
According to embodiments presented herein, the rib member can have a curved body portion with opposing inside and outside surfaces joined together by opposing top and bottom edges and opposing side edges. The rib member can have a dowel, pins and a notched section in the body portion. The dowel can extend radially inward from the inside surface of the body portion. The pins can extend axially away from the top edge of the body portion. The notched section can form a recess along the inside surface and bottom edge of the body portion. The rib member can be removably securable to the ring member whereby the pins of the rib member can be insertable into openings of adjacent flexible tabs of the plurality of flexible tabs and a first tooth of the plurality of spaced-apart teeth in alignment in the first direction with a space between the adjacent flexible tabs is received within the notched section of the rib member. The notched section can be seated on the inside surface of the tooth.
According to embodiments presented herein the ring member can further comprise an outer flange and a middle portion. The middle portion can be between the outer flange and the engagement portion and can be curved to elevate the engagement portion from the outer flange in the first direction. The plurality of spaced apart flexible tabs can encircle the entirety of the engagement portion and the input opening. Each of the plurality of spaced-apart tabs can be substantially equivalent in size and can be spaced a same distance apart from adjacent ones of the plurality of flexible tabs. A first distance can separate the openings of the adjacent flexible tabs and the pins of the rib member can be reciprocally spaced apart from one another by said first distance. The first tooth can be spaced halfway between the openings of the adjacent flexible tabs in a second direction perpendicular to the first direction. The ring member can be provided as an insert between layers of an ostomy barrier. The ring member can be removably securable to an ostomy barrier securable to a user. The plurality of spaced-apart flexible tabs can be curved. Upon being applied to a user, the inside surface of the plurality of flexible tabs can be configured to engage an adjacent parastomal region of the user and pull the adjacent parastomal region towards a pouch-side of the ring member. Upon securing the rib member to the ring member, the adjacent flexible tabs can have reduced flexibility. A plurality of rib members substantially identical to the rib member can be further provided, each of the plurality of rib members can be removably securable and repositionable between adjacent tabs of the plurality of flexible tabs and a tooth of the plurality of spaced apart teeth positioned between the adjacent tabs.
Embodiments presented herein are further directed to a convex support for an ostomy appliance. The convex support can comprise an annular ring member having an interior surface and an engagement portion encircling a centrally-located input opening. The engagement portion can comprise a plurality of spaced-apart flexible tabs extending radially inward into the input opening. The flexible tabs can have opposing side edges and opposing interior and exterior surfaces with an opening extending therebetween. The opening can be centrally located between the opposing side edges. A plurality of spaced-apart teeth can extend radially inward from the inside surface of the ring member into the input opening. The teeth can be in alignment in a first direction with spaces between the plurality of flexible tabs and can have an inside surface facing the interior surface of the plurality of flexible tabs.
According to embodiments presented herein, the convex support can further comprise a rib member. The rib member can have a curved body portion with opposing inside and outside surfaces joined together by opposing top and bottom edges and opposing side edges. The rib member can have a dowel, pins and a notched section in the body portion. The dowel can extend radially inward from the inside surface of the body portion. The pins can extend axially away from the top edge of the body portion. The notched section can form a recess along the inside surface and bottom edge of the body portion. The rib member can be removably securable to the ring member whereby the pins of the rib member can be insertable into openings of adjacent flexible tabs of the plurality of flexible tabs and a first tooth of the plurality of spaced-apart teeth in alignment in the first direction with a space between the adjacent flexible tabs is received within the notched section of the rib member. The notched section can be seated on the inside surface of the tooth.
According to embodiments presented herein the plurality of flexible tabs of the convex support can comprise sixteen tabs that encircle the entirety of the engagement portion and the input opening. Each of the sixteen tabs can be substantially equivalent in size and being spaced a same distance apart from one another. The plurality of spaced-apart teeth can comprise sixteen teeth equivalently spaced apart from one another around the interior side of the ring member. A plurality of rib members substantially identical to the rib member can further be provided and the plurality of rib members can be of a quantity between two and eight. The plurality of spaced-apart teeth can comprise a distal end having an elevated barbed section to retain the rib member thereon. The plurality of spaced-apart teeth can comprise the first tooth, a second tooth and a third tooth located in sequence along a portion of the ring member and the plurality of spaced apart flexible tabs can comprise a first and second tab. The first tab can be aligned in the first direction between the first tooth and the second tooth and the second tab can be aligned in the first direction between the second tooth and the third tooth.
According to embodiments presented herein, the rib member of the convex support can be secured to the ring member. A first portion of the bottom edge of the body portion can be between the first tooth and the second tooth and a second potion of the bottom edge of the body portion can be between the second tooth and the third tooth. The rib member can comprise a first rib member and a second rib member substantially identical to the first rib member. The first and second rib members can be securable to the ring member in adjacent positions alongside one another and upon being secured in the adjacent positions, the first tooth can be between one of the opposing side edges of the first rib member and one of an opposing side edge of the second rib member. The rib member can be securable to the ring member by being snap fit thereon whereby the outside surface of the rib member snaps into place against the interior surface of the ring member.
Other objects, advantages and features of the present disclosure will be understood and appreciated by persons of ordinary skill in the art from consideration of the following specification taken in conjunction with the accompanying drawings.
While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiment illustrated.
Referring now to the accompanying figures, and
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According to embodiments presented herein, the convex ring member 10 can be applied to a user by inserting the stoma through the inlet opening such that the ring member 10 encircles the stoma with the body side 22 facing inward towards the user's body and the pouch-side 24 is facing outward away from the user. In placing the ring member 10 around the stoma, the soft, flexible composition of the ring member 10 and tabs 18a . . . n can gently push on the peristomal skin surrounding the stoma to protrude or project the stoma outward to aid in directing the discharge of effluent from the stoma directly into the ostomy pouch. Upon being applied around the stoma, the user can apply the rib members 40 as desired.
From the subject disclosure, it will be recognized and appreciated, that upon application of ring member 10 around a stoma, the rib members 40 can be snapped into place along the ring member 10 at particular locations where the adjacent stomal area requires deeper convexity or additional firmness or rigidity to be adequately supported. According to embodiments, it will be recognized that the ring member 10 can alternatively be applied to a user with the rib members 40 already in place, such as for example, where a user has knowledge and familiarity with stomal locations that are in need of deeper convexity support and has previously customized the appliance accordingly.
It will be recognized that such capabilities can provide a more customizable ostomy appliance that is adjustable to suit the particular conditions or needs of an individual user. It will be further recognized that such capabilities can reduce the need for providing, or manufacturing multiple different types of specialized ostomy appliances to attempt to suit different individuals which can be commercially impractical. Accordingly, embodiments presented herein can provide adjustable convexity to account for stomal variations between individual users and also stomal changes that may evolve over time with regard to a specific individual user who may need additional support to different areas at different times. According to embodiments presented herein, such individual can add or reduce support to particular stomal areas by modifying use and positioning of the rib members 10. It will be appreciated that such functionality can better prevent undesirable leakage of body waste output which can improve sanitation and reduce embarrassment.
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.
This is a National Stage Application of International Patent Application No. PCT/US2023/066160, filed Apr. 25, 2023, which claims the benefit of and priority to U.S. Provisional Application No. 63/403,098, filed Sep. 1, 2022, the entireties of which are incorporated fully herein by references.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2023/066160 | 4/25/2023 | WO |
Number | Name | Date | Kind |
---|---|---|---|
3970085 | Mersan | Jul 1976 | A |
4219023 | Galindo | Aug 1980 | A |
4419100 | Alexander | Dec 1983 | A |
4592750 | Kay | Jun 1986 | A |
4596566 | Kay | Jun 1986 | A |
4610676 | Schneider | Sep 1986 | A |
4834731 | Nowak | May 1989 | A |
4950223 | Silvanov | Aug 1990 | A |
4973323 | Kaczmarek | Nov 1990 | A |
5004464 | Leise, Jr. | Apr 1991 | A |
5163930 | Blum | Nov 1992 | A |
5195996 | Edwards | Mar 1993 | A |
5257981 | Takahashi | Nov 1993 | A |
5429625 | Holmberg | Jul 1995 | A |
5607413 | Holmberg | Mar 1997 | A |
5730735 | Holmberg | Mar 1998 | A |
6071268 | Wagner | Jun 2000 | A |
6210384 | Cline | Apr 2001 | B1 |
6673056 | Metz et al. | Jan 2004 | B2 |
6689111 | Mulhauser | Feb 2004 | B2 |
6740067 | Leise, Jr. | May 2004 | B2 |
6840924 | Buglino | Jan 2005 | B2 |
7258661 | Davies et al. | Aug 2007 | B2 |
7347844 | Cline | Mar 2008 | B2 |
7857796 | Cline | Dec 2010 | B2 |
8845606 | Nguyen-Demary | Sep 2014 | B2 |
8998862 | Hanuka | Apr 2015 | B2 |
8998867 | Sabeti | Apr 2015 | B2 |
9149265 | Ehrenreich | Oct 2015 | B2 |
9345612 | Hanuka | May 2016 | B2 |
9517157 | Hanuka et al. | Dec 2016 | B2 |
9770359 | Edvardsen et al. | Sep 2017 | B2 |
9943436 | Nguyen-Demary | Apr 2018 | B2 |
10335509 | Kutsukake | Jul 2019 | B2 |
10512562 | Kavanagh et al. | Dec 2019 | B2 |
10524953 | Hanuka | Jan 2020 | B2 |
10537461 | Hanuka | Jan 2020 | B2 |
10653551 | Apolinario | May 2020 | B2 |
10893974 | Nyberg | Jan 2021 | B2 |
20030088219 | Metz | May 2003 | A1 |
20040006320 | Buglino | Jan 2004 | A1 |
20040193122 | Cline | Sep 2004 | A1 |
20050054997 | Buglino | Mar 2005 | A1 |
20060206069 | Cline | Sep 2006 | A1 |
20080119804 | Cline | May 2008 | A1 |
20120059341 | Masters | Mar 2012 | A1 |
20120136324 | Hanuka | May 2012 | A1 |
20130030397 | Sabeti | Jan 2013 | A1 |
20140316360 | Ekfeldt | Oct 2014 | A1 |
20140324002 | Luce | Oct 2014 | A1 |
20160074206 | Nassopoulos | Mar 2016 | A1 |
20160302959 | Kavanagh | Oct 2016 | A1 |
20180333290 | Jones | Nov 2018 | A1 |
20190231580 | Czaplewski | Aug 2019 | A1 |
20190254864 | Czaplewski | Aug 2019 | A1 |
20190380860 | Eggert | Dec 2019 | A1 |
20200100931 | Schoess | Apr 2020 | A1 |
20200253777 | Jones | Aug 2020 | A1 |
20210307952 | Nielsen | Oct 2021 | A1 |
20210369492 | O'Grady | Dec 2021 | A1 |
20220168131 | Heckler | Jun 2022 | A1 |
Number | Date | Country |
---|---|---|
0381393 | Jun 1993 | EP |
1348412 | Jul 2011 | EP |
2370030 | Oct 2011 | EP |
2482767 | Dec 2015 | EP |
2950761 | Dec 2015 | EP |
2497449 | Jan 2016 | EP |
1485048 | Jun 2016 | EP |
3238671 | Nov 2017 | EP |
3270835 | Jan 2018 | EP |
2950761 | Sep 2020 | EP |
9930653 | Jun 1999 | WO |
2015132779 | Sep 2015 | WO |
2020200382 | Oct 2020 | WO |
2020220025 | Oct 2020 | WO |
WO-2020200382 | Oct 2020 | WO |
Entry |
---|
International Search Report issued by ISA/EPO in connection with PCT/US2023/066160 dated Jul. 14, 2023. |
Written Opinion ssued by ISA/EPO in connection with PCT/US2023/066160 dated Jul. 14, 2023. |
Number | Date | Country | |
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63403098 | Sep 2022 | US |