In addition to tracheostomies typically performed by a surgeon, nurse or paramedic in the patient's throat for inserting a tracheostomy tube or endotracheal tube, stomas or wounds in other body locations may also be intentionally created for inserting a tube to drain bodily fluids or to introduce flushing fluids to the body. In order to support the drain and/or flush tube, a support means or holder device is used for maintaining placement of the tube and securing it adjacent to the body. A stoma/seal ring or pad used in cooperation with the holder device prevents the holder from causing trauma and irritation to the wound and adjacent skin as well as to prevent undue exposure to environmental issues, bacteria, moisture, etc., while maintaining integrity and stabilization of the tube during the continuing patient treatment.
The stoma pad/seal ring described herein is configured to cooperate with a fluid handling tube inserted into a body wound and comprises a flexible, resilient, gel-like annular pad having a generally flat bottom surface and a convex annular wall extending upwardly from the bottom surface, and a circular hole extending through the center of the annular wall and the bottom surface.
In one embodiment, the annular pad is provided with a slit from the outside surface of the annular wall to the circular hole whereby the circumference of the annular pad and hole can be expanded somewhat via the slit for attaching the pad to the tube and contracted due to its memory retaining resiliency to its original condition. In another embodiment, the single slit between one outside annular wall surface and the center hole is provided with a tongue-in-groove-like recess and flange arrangement for creating a more effective fluid seal. Other features and embodiments will be described further hereinafter.
Embodiments of support member/holding devices for securing the stoma pad/seal ring are also described.
In the embodiment illustrated in
In another embodiment, referring to
In another embodiment, the slit 26 is provided with a tongue-in-groove type of surface for creating a seal between the two facing slit surfaces. As particularly illustrated in
Referring again to the illustrated embodiment of the convex annular wall 12 of stoma pad 10, the distance across the convex upper or top connecting surface 22 is greater than the height of either of the inside or outside wall surfaces, which are generally of equal height. The thickness of the annular wall between the inside wall surface 18 and outside wall surface 20 is greater than the height of the annular wall. However, in other embodiments, the thickness of the annular wall and the dimension across the upper connecting surface may be substantially the same as or less than the height of the inside and outside wall surfaces. Moreover, the circumference of the pad at the outer and inner wall surfaces may be varied as desired to accommodate different size wounds as well as different size tubes. Thus, a great variety of different sizes of the pad may be formed and the size of the stoma pad described herein is not to be limited to specific heights or thickness of the annular pad nor to specific inside or outside wall surface circumferences.
In one embodiment, the stoma pad is formed of a very soft, and memory retaining flexible polyurethane or silicon rubber composition. A specific example of one material is polyurethane having a Shore durometer hardness of between about 15 and about 40. Another pad composition comprises a soft silicon gel encased in a thin-flexible, soft polyurethane cover, layer or skin. Such compositions and methods of manufacture of such materials are known to those skilled in the art. Again, the material may be very pliant and flexible whereby the surfaces can conform to surfaces of a holder as well as to securing the tube from passing fluid including air or moisture, etc. as well as for conforming to and stabilizing the wound to which it is compressed. The pad may also be treated with an anti-microbial material such as silver nitrate or other composition capable of releasing antiseptic or resisting and preventing infection of the patient's skin and wound against which the pad rests.
Embodiments of a stoma pad/seal described herein may be used in an assembly which includes a holder for maintaining the pad in place as well as stabilizing the fluid directing tube around which the pad is secured. Observing
A holder embodiment is shown in
In yet another embodiment, the stoma pad may be secured to the holder by adhesive, applied to either the bottom stoma pad surface or the pad engaging the holder surface, or both.
In another embodiment, an adhesive bandage holder, of the type described and shown in
The stoma pad/seal described herein is shaped, formed and configured to allow the pad to act as a seal preventing air and fluid leaks when the stoma to which it is engaged becomes enlarged or stretched as a fluid handling tube as previously described causes expansion of the stoma over time. The soft, flexible and pliable composition of the pad and smooth surface which gently is positioned on the wound is intended to prevent inflammation of the patient's skin adjacent to the stoma, and, unlike gauze pads or the like, does not need to be changed thereby substantially reducing the likelihood of contamination and irritation of the wound during such procedures.
This application claims priority to U.S. Provisional Patent Application No. 61/415,235 filed Nov. 18, 2010 which is incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
3422817 | Mishkin et al. | Jan 1969 | A |
4617691 | Monti et al. | Oct 1986 | A |
4931045 | Steer | Jun 1990 | A |
5058579 | Terry et al. | Oct 1991 | A |
5471980 | Varner | Dec 1995 | A |
D385741 | Lebenbaum | Nov 1997 | S |
5918599 | Shesol | Jul 1999 | A |
6105577 | Varner | Aug 2000 | A |
6689111 | Mulhauser et al. | Feb 2004 | B2 |
6793434 | Olson | Sep 2004 | B1 |
8469024 | Loescher | Jun 2013 | B2 |
20020077611 | von Dyck et al. | Jun 2002 | A1 |
20060122595 | Farin et al. | Jun 2006 | A1 |
20080119804 | Cline et al. | May 2008 | A1 |
20090318883 | Sugahara et al. | Dec 2009 | A1 |
Entry |
---|
Kapi-Gel tracheostoma spacer, Kapitex Healthcare Ltd, Sep. 1, 2010. |
The Provox® System Catalog 2010, Atos Medical AB, Aug. 5, 2010. |
Number | Date | Country | |
---|---|---|---|
20120130297 A1 | May 2012 | US |
Number | Date | Country | |
---|---|---|---|
61415235 | Nov 2010 | US |