Gastro-intestinal tube with dissolvable support bolster

• US 6,186,985 B1
• Filed: 10/03/1997
• Issued: 02/13/2001
• Est. Priority Date: 10/03/1997
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Snow, Todd
• Primary Examiner(s): Kennedy, Sharon
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US08/943,918
• Time in Patent Office: 1,229 Days
• Field of Search: 604/264, 604/265, 604/270, 604/174, 604/175
• US Class Current: 604/175
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0038 expandable, e.g. umbrella type
• CPC Class Codes: A61J 2200/60 biodegradable
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type

Abstract

A gastro-intestinal tube which provides rigid support during stomal formation, while allowing tube removal by pulling from outside the abdominal wall. The tube has proximal and distal ends, a deformable internal bolster attached to the distal end, and a dissolvable support bolster placed around the tube proximal to the internal bolster. The support bolster is made of a dissolvable material, such that the bolster provides a high degree of securement to the gastro-intestinal tube during formation of the stoma, and dissolves to allow tube removal after the stoma has formed. In an alternate embodiment, the bolster has a coating of a medicating agent.

Claims

1. A gastro-intestinal device for being placed within the anatomy comprising:

a tube having a shaft and proximal and distal ends;

an internal bolster attached to the distal end of the tube, internal bolster having a collapsible structure which allows removal of the device from within the anatomy; and

a dissolvable in-vivo internal support bolster which, when the device is properly placed within the anatomy, fits around the tube at the tube'"'"'s distal end and proximal to the internal bolster, within the anatomy, and which prevents inadvertent removal of the device.

2. A gastro-intestinal device as set forth in claim 1, wherein the support bolster comprises one or more of:

a(n) aliphatic polyester, poly(phosphoester), poly(anhydridc), poly(orthoester), poly(phosphazene), polysaccharide, peptide-based polymer, and poly(∝

-ester).

3. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has an outer diameter of approximately 2 cm.

4. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a dissolution time of between 2 and 4 weeks in vivo.

5. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a dissolution time of up to 6 months in vivo.

6. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has an external coating comprising an anti-inflammatory agent.

7. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has an external coating comprising an antibiotic agent.

8. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has an external coating comprising an antiviral agent.

9. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has an external coating comprising an antimicrobial agent.

10. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has an external coating comprising an antiencrustation agent.

11. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has an external coating comprising a disinfecting antgent.

12. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a porous structure capable of holding an anti-inflammatory agent within the pores.

13. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a porous structure capable of holding an antibiotic agent within the pores.

14. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a porous structure capable of holding an antiviral agent within the pores.

15. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a porous structure capable of holding an antimicrobial agent within the pores.

16. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a porous structure capable of holding an antiencrustation agent within the pores.

17. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a porous structure capable of holding an disinfecting agent within the pores.

18. A gastro-intestinal device as set forth in claim 1, wherein a portion of the tube shaft, proximally adjacent to the internal bolster is coated with an anti-inflammatory agent.

19. A gastro-intestinal device as set forth in claim 10, wherein the portion of the tube coated with an anti-inflammatory agent has a length of approximately 9 cm.

20. A gastro-intestinal device as set forth in claim 1, wherein a portion of the tube, proximally adjacent to the internal bolster, is coated with an antibiotic drug.

21. A gastro-intestinal device as set forth in claim 20, wherein the portion of the tube coated with an antibiotic drug has a length of approximately 9 cm.

22. A gastro-intestinal device as set forth in claim 1, wherein a medicating agent is incorporated into the support bolster.

23. A gastro-intestinal device as set forth in claim 1, wherein a medicating agent is incorporated into the support bolster and dispensed therefrom.

24. A gastro-intestinal device as set forth in claim 1, wherein a the support bolster has a membrane which limits the rate of dissolution of the support bolster.

25. A gastro-intestinal device as set forth in claim 22, wherein the support bolster has a membrane which limits the rate at which the medicating agent is dispensed.

26. A gastro-intestinal device as set forth in claim 1, wherein the internal bolster is concave, as viewed from a proximal vantage point.

27. A gastro-intestinal device as set forth in claim 1, wherein the internal bolster is convex, as viewed from a proximal vantage point.

28. A gastro-intestinal device as set forth in claim 1, wherein the support bolster is concave, as viewed from a proximal vantage point.

29. A gastro-intestinal device as set forth in claim 1, wherein the support bolster is convex, as viewed from a proximal vantage point.

30. A gastro-intestinal device as set forth in claim 1, wherein the support bolster is shaped as a disk.

31. A gastro-intestinal device as set forth in claim 1, wherein the support bolster has a convex distal surface, as viewed from a proximal vantage point, and a substantially planar proximal surface.

32. A gastro-intestinal device for being placed within the anatomy comprising:

a tube having a shaft with proximal and distal ends;

an internal bolster attached to the distal end of the tube, said internal bolster having a collapsible structure which allows traction removal of the tube from within the anatomy; and

a biocompatiblc, dissolvable in-vivo internal support bolster which when the device is properly placed within the anatomy, fits around the tube at the distal end and proximal to the internal bolster within the anatomy, wherein the internal support bolster prevents inadvertent removal of the device, and wherein the internal support bolster is made with one or more of a(n);

aliphatic polyester, poly(phosphoester), poly(anhydride), poly(orthoester), poly(phosphazane), polysaccharide, peptide-based polymer, and poly(∝

-ester).

33. A gastro-intestinal device for being placed within the anatomy comprising:

a tube having proximal and distal ends, a tube shaft extending from the proximal end to the distal end;

an internal bolster attached to the distal end of the tube having a collapsible structure which allows traction removal from within the anatomy; and

a biocompatible, dissolvable in-vivo internal support bolster which when the device is properly placed within the anatomy, fits around the tube at the distal end and proximal to the internal bolster within the anatomy, wherein the internal support bolster prevents inadvertent removal of the device from the anatomy and is made of biocompatible, dissolvable material, and the internal support bolster further having a coating of medicating agent.