CN-122003257-A - Ostomy skin barrier device

Abstract

The present invention provides an ostomy skin barrier device comprising a front side and a back side, wherein at least a portion of the front side comprises a medical adhesive, wherein the medical adhesive comprises at least one pregelatinized starch or pregelatinized modified starch, and an opening in the skin barrier device, the opening being capable of at least partially receiving a stoma in use.

Inventors

• D. HANSEN
• K. HANSEN
• N. Ricardo
• E.CHEN
• T. Flock

Assignees

• 康沃特克有限公司

Dates

Publication Date

20260508

Application Date

20241016

Priority Date

20231207

Claims (20)

1. 1. An ostomy skin barrier device comprising: a front side and a back side, wherein at least a portion of the front side comprises a medical adhesive, wherein the medical adhesive comprises pregelatinized starch or pregelatinized modified starch, and An opening in the skin barrier means for at least partially receiving a stoma in use.
2. 2. The ostomy skin barrier device of claim 1, wherein the pregelatinized starch or pregelatinized modified starch comprises no more than 5% by weight amylose.
3. 3. The ostomy skin barrier device according to claim 1 or 2, wherein the pregelatinized starch or pregelatinized modified starch comprises at least 95% by weight of amylopectin.
4. 4. The ostomy skin barrier device of any one of the preceding claims, wherein the pregelatinized starch or pregelatinized modified starch is uncrosslinked.
5. 5. A ostomy skin barrier device according to any one of claims 1 to 3, wherein the pregelatinized starch or pregelatinized modified starch is cross-linked.
6. 6. The ostomy skin barrier device according to any one of the preceding claims, wherein the amount of pregelatinized starch or pregelatinized modified starch is from 10 to 40% by weight of the total weight of the adhesive.
7. 7. The ostomy skin barrier device of any one of the preceding claims, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized di-starch.
8. 8. The ostomy skin barrier device of any one of the preceding claims, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized di-starch adipate or pregelatinized di-starch phosphate.
9. 9. The ostomy skin barrier device of any one of the preceding claims, wherein the pregelatinized starch or pregelatinized modified starch is pregelatinized acetylated distarch adipate or pregelatinized hydroxypropyl distarch phosphate.
10. 10. The ostomy skin barrier device of any one of the preceding claims, wherein the medical adhesive comprises pectin.
11. 11. The ostomy skin barrier device of claim 10, wherein the amount of pectin is 10 to 30 weight percent of the total weight of the adhesive.
12. 12. The ostomy skin barrier device of any one of the preceding claims, wherein the adhesive comprises polyisobutylene.
13. 13. The ostomy skin barrier device of claim 12, wherein the amount of polyisobutylene is 5 to 50 weight percent of the total weight of the adhesive.
14. 14. The ostomy skin barrier device according to any one of the preceding claims, wherein the adhesive composition comprises cellulose or a cellulose derivative.
15. 15. The ostomy skin barrier device of claim 14, wherein the cellulose derivative is carboxymethyl cellulose.
16. 16. The ostomy skin barrier device according to claim 14 or 15, wherein the amount of cellulose derivative is 10 to 30% by weight of the total weight of the adhesive.
17. 17. The ostomy skin barrier device of any one of the preceding claims, wherein the medical adhesive comprises: 10 to 40 wt% of pregelatinized starch or pregelatinized modified starch; 10 to 30% by weight pectin; 5 to 50% by weight of polyisobutene, and 10 To 30% by weight of cellulose or cellulose derivative.
18. 18. The ostomy skin barrier device according to any of the preceding claims, wherein the thickness of the adhesive layer is 0.05 to 2 mm.
19. 19. A medical adhesive comprising at least one starch or modified starch, wherein the starch or modified starch comprises no more than 5 wt% amylose.
20. 20. A medical adhesive comprising at least one starch or modified starch, wherein the starch or modified starch comprises at least 95 wt.% amylopectin.

Description

Ostomy skin barrier device Technical Field The present invention relates to an ostomy skin barrier device comprising a medical adhesive, and a medical adhesive. Background Medical adhesives typically contain gelatin, particularly gelatin of animal origin, which may have negative effects such as increased risk of viral infection. The use of medical adhesives containing gelatin may also be limited, for example, not for broken skin unless they meet the specifications for class II or class III medical devices. Patients requiring long-term use of medical adhesives, such as ostomy patients, may prefer to use alternatives that are free of animal-derived components, while not affecting the performance of the medical adhesive. It would therefore be advantageous to provide a gelatin-free medical adhesive for long-term use, such as for ostomy bags. It would also be advantageous to provide an ostomy skin barrier device for long term use comprising a gelatin-free medical adhesive. It would be advantageous to provide a skin barrier device comprising a medical adhesive, wherein the skin barrier device has good wet integrity, does not corrode in water, and is resistant to enzymes, and therefore does not corrode in the presence of enzymes. It would be advantageous to provide a skin barrier device for an ostomy bag comprising a medical adhesive, wherein the skin barrier device has good wet integrity, does not corrode in water, and is resistant to enzymes, thereby protecting the patient's skin from irritation. It would be advantageous to provide a skin barrier device for an ileostomy bag comprising a medical adhesive, wherein the skin barrier device has good wet integrity, does not corrode in water, and is resistant to enzymes, thereby protecting the patient's skin from irritation by enzyme-containing exudates. Embodiments of the present invention aim to overcome one or more of the problems of the prior art, whether or not such problems have been explicitly disclosed herein. Disclosure of Invention According to a first aspect of the present invention there is provided an ostomy skin barrier device comprising a front side and a back side, wherein at least a portion of the front side comprises a medical adhesive, wherein the medical adhesive comprises at least one pregelatinized starch (pre-gelatinized starch) or pregelatinized modified starch (pre-gelatinized modified starch), and an opening in the skin barrier device, which opening is capable of at least partially receiving a stoma in use. Pregelatinization refers to a precooking step in which starch or modified starch is heated with water to break intermolecular bonds in the starch molecules, and then the starch or modified starch is dried. An advantage of pregelatinized starch or pregelatinized modified starch is that pregelatinization can improve the interaction of starch or modified starch with other materials. In addition, pregelatinized starch or pregelatinized modified starch can improve wet integrity due to the reduced amount of modified starch lost from the binder in the presence of water, which is also one of its advantages. Pregelatinized starch or pregelatinized modified starch can be advantageous because medical adhesives containing pregelatinized starch or pregelatinized modified starch can absorb moisture at body temperature, thereby preserving the integrity of the medical adhesive upon exposure to water. The pregelatinized starch or pregelatinized modified starch can comprise no more than 5% by weight amylose. The pregelatinized starch or pregelatinized modified starch can comprise no more than 4 wt.%, 3 wt.%, 2 wt.%, 1 wt.%, 0.8 wt.%, 0.6 wt.%, 0.5 wt.%, 0.4 wt.%, 0.3 wt.%, 0.2 wt.% or 0.1 wt.% amylose. The pregelatinized starch or pregelatinized modified starch can be amylose-free or substantially amylose-free. Pregelatinized starch or pregelatinized modified starch that is amylose-free or substantially amylose-free may comprise only amylopectin polymer units (amylopectin) and no amylose polymer units (amylose). Pregelatinized starch or pregelatinized modified starch comprising low amounts of amylose or no amylose may be advantageous because it can result in adhesives having improved wet integrity properties. Pregelatinized or modified starches containing low amounts of amylose may also have advantageous wet integrity properties due to their higher water solubility and thus reduced wet integrity as a result of their linear structure and lower molecular weight. The pregelatinized starch or pregelatinized modified starch can comprise at least 95% by weight amylopectin. The pregelatinized starch or pregelatinized modified starch can comprise at least 96 wt.%, 97 wt.%, 98 wt.%, or at least 99 wt.% amylopectin. The pregelatinized starch or pregelatinized modified starch can comprise 100% by weight amylopectin. Pregelatinized starches or pregelatinized modified starches comprising high amounts of amylopectin can be advantageous in that they can produce adhesives h