Stock material or miscellaneous articles – Web or sheet containing structurally defined element or... – Adhesive outermost layer
Reexamination Certificate
2003-01-23
2004-06-08
Seidleck, James J. (Department: 1711)
Stock material or miscellaneous articles
Web or sheet containing structurally defined element or...
Adhesive outermost layer
C428S3550CN, C428S336000, C428S315700, C428S317500, C428S317700
Reexamination Certificate
active
06746765
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a hydrocolloid adhesive tape useful in ostomy, wound and skin care applications.
BACKGROUND
As a result of a variety of medical conditions it may be in the best interests of the health of an individual to undergo ostomy surgery. In this procedure portion of the intestine or urinary tract is drawn through an opening made in the abdomen (stoma) and then sutured to the skin. Typically an odor-proof pouch is attached to the body to collect effluent from the stoma. Often this attachment is accomplished using an ostomy wafer that has been taken from a planar slab of adhesive and cut to fit the wearer. Attachment of a pouch to the wafer completes the device for collection of fecal or urinary output. Hydrocolloid adhesives of the type described by U.S. Pat. Nos. 3,339,546 or 4,551,490 have been demonstrated to be especially suited to this purpose since their unique ability to absorb moisture enables them to remain securely adhered to the skin for wearing times of up to a week or more.
Security of the device is a critical need of the ostomate because if the adhesive should fail even partially then effluent from the stoma will have an opportunity to attack the peristomal skin causing it to break down rapidly. It is known by those skilled in the art that the security of an ostomy adhesive depends strongly on its thickness. Thicker adhesives adhere more strongly. It is also desirable to have a thick adhesive next to the stoma to protect the peristomal skin. Thicker adhesives resist the corrosiveness of stoma output better than thin adhesives. Additionally, the overall wearing time of the adhesive will be longer for thicker adhesive. Hydrocolloid adhesives rely on absorbency to manage perspiration and remain attached to the skin of the wearer. The absorbing capacity of the device depends on the amount of hydrocolloid powders available. Thicker devices have more hydrocolloids per area of attachment and so remain viable on the skin for longer periods of time.
It is also known by those skilled in the art of hydrocolloid adhesives that several practical considerations limit how thick the adhesive can be. For example, the comfort of the wearer will be greatly improved if the adhesive can be made thin. Thin adhesives are more flexible. They feel lighter when worn. They also conform better to the abdomen as it twists and stretches in the normal course of everyday activities. Because thinner adhesives are less obvious they fulfill another important need of the wearer, discretion. Thinner adhesives also avoid the tendency of thick adhesives to lift at the edges. While a thick adhesive will strongly resist lifting at its center the same rigidity that helps it remain well attached at that point may also cause it to lift slightly along its perimeter. One final reason why thick adhesives are not always optimal is their tendency to leave more residue on the skin than thinner adhesives do.
For secure attachment to the skin it can be seen that thicker adhesives have several advantages. However, they also have drawbacks that can be addressed by reducing their thickness. A balance is required that considers the specific needs of the intended application. For an ostomy device, security is paramount. With the invention of hydrocolloid adhesives came the design of new ostomy products to take advantage of their superiority adhesive technology for this challenging application. Ostomy wafers for these products were designed to be thick to ensure that they would remain well adhered and achieve a long and consistent wear time. For this reason most ostomy wafers in the marketplace typically range in thickness from about 0.040 to 0.100 inch.
As development of ostomy devices progressed it was recognized that a composite wafer could be designed to be thick around the stoma and thin at the edges. U.S. Pat. No. 4,775,374 discloses such a device. In that patent a number of examples are described wherein a relatively thick disc of hydrocolloid adhesive is surrounded by a thinner tape-like adhesive attached at its perimeter. The advantage of this design is that the thicker adhesive provides the area around the stoma with secure adhesion, peristomal skin protection, and adequate absorption capacity for long wear times. The thinner adhesive at its edges prevents edge lifting, helps to minimize residue on the skin, and provides an overall lightness and flexibility that is dramatically more comfortable to wear.
The value of combining thick and thin adhesive profiles in the same ostomy device as disclosed in U.S. Pat. No. 4,775,374 has been confirmed by a number of other patents that have disclosed alternative methods to make adhesive wafers with variable adhesive thickness. For example, U.S. Pat. No. 5,074,852 discloses a composite wafer with a relatively thin extruded layer of occlusive hydrocolloid surrounding a thicker hydrocolloid disc. U.S. Pat. No 5,133,821 describes a process using a contouring roller to yield a hydrocolloid wound dressing. U.S. Pat. No. 5,716,475 describes a process for compression molding adhesive to yield a non-uniform thickness skin barrier. U.S. Pat. No. 5,811,116 describes embossing an adhesive, and U.S. Pat. No. 5,834,009 describes a contoured adhesive wafer with a thin peripheral section and a thick body section. Finally, U.S. Pat. No. 5,935,363 describes essentially a calendering process for producing shaped wafers.
It is believed these disclosures and others in the prior art all rely on thermoplastic methods of processing where the adhesive is heated and shaped to its final configuration before it is cooled. It has been found that the physical dimensions of the hydrocolloid powders establish a lower limit for the thickness of useful adhesives that can be produced by these processes. As the thickness of the adhesive decreases below about 0.010 inch thick it becomes more and more difficult to attain a uniform, continuous and useful layer of adhesive. The hydrocolloid powders interfere with flow of the adhesive and cause discontinuities in the product. They can stick out as lumps and interfere with the skin contacted needed for good adhesion. They can tear openings in the in-process adhesive. Below about 0.010 inch thick the adhesive has limited fluidity and strength and will not recover from these defects. It is believed that this reason explains why hydrocolloid adhesives produced by thermoplastic processes are not commercially available below a thickness of about 0.010 inch.
As previously mentioned U.S. Pat. No. 4,775,374 discloses an ostomy wafer wherein a relatively thick disc of hydrocolloid adhesive is surrounded by a thinner tape-like adhesive attached at its perimeter. According to the patent the tape-like adhesive disclosed can be of the acrylic type as in U.S. Pat No. 3,12,021, but is preferably made from the same hydrocolloid adhesive as the central disk component of the ostomy wafer. The microporosity of the thin adhesive further distinguishes it from the thicker adhesive, which is occlusive. The difference in permeability is explained to arise from a difference in processing methods. For both the acrylic and the hydrocolloid based formulations of the adhesive tape disclosed in '374 the need for microporosity results from the requirement that adhesive must manage perspiration to remain securely attached to the skin for extended wearing times. Neither the acrylic nor the hydrocolloid formulation will absorb an appreciable amount of moisture. Both rely of transmission of perspiration through the thickness of the device for their bond strength.
One limitation of the microporous nature of these adhesives is that they do not resist moisture from external sources well. For example, during bathing or showering water easily permeates through the adhesive backing and the adhesive itself. As a result, the tape collar can be overwhelmed with moisture at its interface with the skin, and the bond will fail. Very thin, microporous, hydrocolloid adhesives are especially vulnerable to this failure mode as they are water-loving structures t
Bristol--Myers Squibb Company
Krieger Stuart E.
Seidleck James J.
Tran Thao
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