Source: https://patents.google.com/patent/US7347844B2/en
Timestamp: 2018-07-23 04:46:07
Document Index: 440397285

Matched Legal Cases: ['art 98', 'art 98', 'art 98', 'art 98', 'art 98', 'art 98', 'art 98', 'art 98', 'art 98', 'art 98', 'art 98']

US7347844B2 - Ostomy appliance having pressure applying member - Google Patents
US7347844B2
US7347844B2 US10397928 US39792803A US7347844B2 US 7347844 B2 US7347844 B2 US 7347844B2 US 10397928 US10397928 US 10397928 US 39792803 A US39792803 A US 39792803A US 7347844 B2 US7347844 B2 US 7347844B2
US20040193122A1 (en )
This application is a continuation-in-part of Ser. No. 10/107,998, filed Mar. 27, 2002 now U.S. Pat. No. 6,723,079 issued on Apr. 20, 2004.
Another aspect of the invention may relate to a sealing member for providing a seal around the stoma. Sealing against or around the stoma is difficult. As well as being comfortable for the ostomate to wear, any seal must not exert too high a pressure on the stoma. Too high a pressure may damage the stoma, and prevent blood flow to the tissue. Various moldable and non-moldable sealing members have been proposed in the art, but this aspect of the invention may relate to a substantially non-moldable, elastomeric sealing member. The term “non-moldable” may mean that the sealing member is not easily plastically deformable when in use, in contrast to a moldable sealing member which is intended to be manually shaped by the ostomate in use. For example, U.S. 60071268 describes an ostomy faceplate including a pad of a barrier adhesive, a non-moldable sealing ring of silicon foam, and a blotter-ring disposed between the pad and the sealing ring. The sealing ring is provided by a soft elastomeric doughnut (or other convex cross-section profile) which sits laterally (radially) outside the stoma to provide a gentle, laterally acting, O-ring type seal contacting the stoma. A potential disadvantage of such a seal is that the seal area is relatively limited. The seal may be relatively weak and vulnerable to leakage when contacted by human waste for extended periods of time, or under significant waste pressure (for example, in a controlled discharge device).
Means may be provided for directly or indirectly applying pressure to the sealing member to urge the sealing member against the stoma and/or peristomal skin. Such pressure applying means may, for example, comprise one or more of; a convex shape defining member; a resilient pressure applying member; an inflatable (or pre-inflated) member; a resiliently compressible material, such as foam. The pressure applying means may apply pressure directly or indirectly to a surface of the sealing member facing away from the skin.
The stoma engaging portion 34 may be configured to overlap the stoma 22 for sealing against the stoma 22. The stoma engaging portion 34 may have a stoma contacting surface 36 of a generally closed loop, concave configuration, surrounding an opening 38. The concave configuration may be generally curved in an axial direction (e.g. flared or dished), or generally straight in an axial direction (e.g. frusto conical). The concave configuration enables the stoma contacting surface 36 to at least partly cup the surface of the stoma 22. Such a concave or cupped contact can provide a relatively large sealing area, especially in contrast to a convex sealing member that arcs away from the stoma surface.
The sealing member 18 may, for example, be made of plastics foam or a low durometer elastomer such as Silicone or Urethane. These materials may provide excellent cushioning properties (e.g., for comfort), and excellent elastomeric conformity (e.g., to achieve a closely fitting seal). The sealing member 18 is preferably impermeable, and may be of closed cell foam, or of open cell foam having an impermeable surface or skin. The sealing member may also be of a composite structure with an impermeable bottom surface and an open cell upper element. Typically the sealing member 18 may be less than about 2 mm in thickness, for example, about 1mm thick. However, sealing members greater than 1 or 2 mm in thickness may be used as well. Composite sealing members consisting of two or more materials may be 10mm-13mm or more in thickness.
The sealing member 18 seals the gap between the edge of the adhesive member 12 and the stoma 22, to prevent body waste from contacting, and potentially leaking under, the adhesive member 12. The adhesive member 12 may erode if contacted by body waste, and the adhesive bond to the skin 20 may also be weakened or lose integrity. The resilience of the sealing member 18 can ensure a comfortable, yet snug fit around the stoma, and provide a reliable seal against waste egress. The concave configuration of the stoma contacting portion 34 provides a large sealing area.
Referring to FIG. 4, the faceplate 10 of the third embodiment is similar to that of the preceding embodiments, except that an additional shape defining member 50 is provided. The shape defining member 50 is shaped to define a convex bulge 51 to apply pressure to the skin 20 peristomally. The shape defining member 50 is preferably relatively stiff at least compared to the sealing member 18. The shape defining member 50 may be made of any suitable material, such as plastics (for example, polyethylene) or metal (for example, stainless steel). The shape defining member 50 may be substantially rigid, or resilient. In the present embodiment, the shape defining member 50 comprises a spring, in the form of a diaphragm spring having a support portion 52 engaged under the undercut lug 42 (described in the second embodiment), and a convex tapered (e.g. conical) portion 54. A spring is preferred to be able to adapt to different individual's stomas 22, and to provide a degree of cushioning for a comfortable fit.
The sealing member 150 and/or the adhesive pad 12 may be pre-sized, or one or both of these elements may be cut to a desired shape and/or size by the ostomate. Although not illustrated explicitly in FIG. 19, a shape defining member 50/80 of one or more of the preceding embodiments may be used in the eighth embodiment, to further increase the sealing force exerted through the sealing member 18.
Referring to FIG. 10, the ninth embodiment relates to a controlled discharge device 90 which may include the faceplate 10 and elastomeric sealing member 18 of any of the preceding embodiments. In FIG. 10, the sealing member 18 is depicted schematically to, have a peristomal bulge 18 a, and a stoma contacting surface, but it will be appreciated that the specific shape and configuration of the sealing member 18 and/or the shape defining member 50/80 (if provided), and the adhesive member 12, may vary, for example, as illustrated in the preceding embodiments.
When the balloon 94 is inflated, a stoma occluding surface 100 of the balloon 94 may be urged against the stoma 22. The stoma occluding surface 100 may drape over the stoma 22, and also over the stoma engaging portion 34 of the elastomeric sealing member 18. The stoma occluding surface 100 may be profiled (e.g. pleated or constrained, or molded) to have a non-planar shape. For example, the stoma occluding surface may have a natural concave shape generally to complement the shape of the stoma 22. Alternatively, the stoma occluding surface 100 may have a natural planar shape which may crease and/or fold as the stoma occluding surface 100 is pressed against the projecting stoma 22, to adapt to the projecting shape.
Referring to FIG. 21, the nineteenth embodiment is similar to the eighteenth embodiment, except for the configuration of the confinement volume seal. In FIG. 20, the foam wall 110 does not extend the entire height of the cap. Instead, an inflatable confinement member 160 is disposed on the underside of the cap to bear on the foam wall 110. The confinement member 160 may be generally annular or toroidal and, in the example illustrated, has a width approximately equal to that of the foam wall 110.
The confinement member 160 is configured such that it does not apply a force directly to the stoma 22. As in the eighteenth embodiment, the elastomeric sealing member is in the form of a gasket 150 that overlaps the inner edge 12 c of the adhesive pad 12. A portion 150 c of the gasket may bear against the peristomal skin 20. In this embodiment, the gasket 150 may be configured not to apply a sealing pressure directly to the stoma 22.
In the example illustrated, the balloon 94 is supported by the second cap part 98 b that is coupled to the collector 102. The second cap part 98 b is coupled to an outer cap cover 98 d to depend from the cover 98 d. The cover 98 d has a skirt or sidewall 98 e that extends towards the faceplate 10, and is releasably secured to the first cap part 98 a by the releasable connection 98c. In this example, the releasable connection 98 c is a mechanical catch. The height of the sidewall 98 e may determine the “height” of the second cap part 98 above the faceplate 10, and hence can control the extent to which the balloon 94 is pressed against the stoma 22. A range of outer covers 98d having different sidewall heights 98 e may be produced. An ostomate may choose (or be prescribed) an appliance having a particular sidewall height to suit his or her stoma.
Referring to FIG. 27, the twenty third embodiment is similar to the twenty first embodiment. The main difference lies in the implementation of the releasable connection 98 c between the outer cap cover 98 d and the first cap part 98 a. In the present embodiment, a screw threaded connection is formed between a first screw thread 180 on the first cap part 98 a, and a second screw thread 182 on the side wall 98 e of the outer cap cover 98 d. An ostomate can adjust the volume (and hence pressure) of the balloon 94 by rotation of the outer cap cover 98 d relative to the first cap part 98 a. Rotation in one direction (e.g. counterclockwise) may increase the distance of the outer cap cover 98 d (and hence the second cap part 98 b) from the first cap part 98 a. Rotation in the other direction (clockwise) may reduce the distance of the outer cap cover 98 d (and hence the second cap part 98 b) from the first cap part 98 a.
adhesive means secured to the ostomy appliance for removably adhering the ostomy appliance to an ostomate's skin, adhesive means including an adhesive member having an inner periphery and a stomal aperture;
sealing and protecting means for sealing the inner periphery of the adhesive member around the stomal aperture and protecting the adhesive member from contact by stomal discharge, said sealing and protecting means including a pressurizable elastometric sealing member having an outer surface facing away from the ostomate's skin; and
pressure producing and applying means for producing pressure from a source external to a stoma and applying said externally sourced pressure directly or indirectly to said outer surface of said pressurizable elastometric sealing member and urging said sealing member towards the skin, said producing and applying means including a cap on said adhesive member defining a space therebetween containing at least a portion of said pressure producing and applying means.
2. The ostomy appliance according to claim 1, wherein the sealing member at least partly overlaps an edge of the adhesive member, to define an overlapped seal.
3. The ostomy appliance according to claim 1, wherein the sealing member projects inwardly of the inner periphery of the adhesive member.
4. The ostomy appliance according to claim 3, wherein the sealing member comprises a tissue contacting portion for contacting a portion of the ostomate's tissue.
5. The ostomy appliance according to claim 4, wherein the tissue contacting portion comprises a peristomal skin contacting portion.
6. The ostomy appliance according to claim 5, wherein the sealing member is configured not to contact the stoma.
7. The ostomy appliance according to claim 4, wherein the tissue contacting portion comprises a stoma contacting portion.
8. The ostomy appliance according to claim 1, wherein the pressure producing and applying means is configured to apply pressure directly or indirectly to the adhesive member.
9. The ostomy appliance according to claim 1, wherein the pressure producing and applying means is configured to apply pressure directly or indirectly to a region of the sealing member projecting radially inward of the inner periphery of the adhesive member.
10. The ostomy appliance according to claim 1, wherein the pressure producing and applying means comprises a resiliently compressible member.
11. The ostomy appliance according to claim 10, wherein the pressure producing and applying means comprises resiliently compressible foam.
12. The ostomy appliance according to claim 1, wherein the ostomy appliance includes a controlled discharge device.
13. The ostomy appliance according to claim 1, wherein the ostomy appliance includes a collection pouch.
US20040193122A1 true US20040193122A1 (en) 2004-09-30
US7347844B2 true US7347844B2 (en) 2008-03-25
US3612053A (en) 1969-06-23 1971-10-12 Minnesota Mining & Mfg Ostomy sealing washer
US4062361A (en) 1974-07-08 1977-12-13 Coloplast International A/S Bilaminar ostomy sealing disc
US5330455A (en) 1992-04-15 1994-07-19 Mckay Lester M Enterostomy appliance
Search report for EP 1 348 411 A1, dated Jun. 25, 2003. *