Biodegradable drains for medical applications

• US 20060142736A1
• Filed: 11/03/2003
• Published: 06/29/2006
• Est. Priority Date: 11/01/2002
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Polyganics B.V. (Collagen Matrix, Inc.)
• Inventors: Hissink, Catharina Everdina, Steendam, Rob, Zuidema, Johan, Gibcus, Linda Joan
• Granted Patent: US 8,187,254 B2
• Time in Patent Office: Days
• US Class Current: 604/540
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61L 29/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0668 Middle ear
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

The invention relates, generally, to medical appliances. More particularly, it relates to tubular shaped devices used as drains for draining fluids (liquids and/or gases) from antrums or other parts of the human or animal body. According to the present invention a drain is provided, which is suitable for draining a human or animal antrum, which drain comprises a synthetic biodegradable material, preferably a biodegradable polymer.

Claims

1. Drain suitable for draining a human or animal antrum, organ or tissue, characterized in that it comprises an elastic biocompatible, biodegradable synthetic polymer, which polymer has at least one softening point (glass transition temperature) of at most mammalian body temperature.

2. Drain according to claim 1, which essentially entirely consists of said synthetic biodegradable polymer.

3. Drain according to claim 1, wherein the polymer has at least one softening point (glass transition temperature) of at most 37°

C.

4. Drain according to claim 1, wherein the biodegradable polymer comprises a polyester, polycarbonate, polyester-carbonate, polyanhydride, polyurethane and/or polyamide which are optionally combined with polyether groups.

5. Drain according to claim 4, wherein:

the polyester is selected from lactide polyester, ε

-caprolactone polyester, glycolide polyester, or copolymers thereof; and

/or

the polyether is selected from polyethyleneglycol, polypropyleneglycol, copolymers thereof and polytetramethyleneoxide (PTMO).

6. Drain according to claim 5, wherein the polyester is a random DL-Lactide-ε

-caprolactone copolyester, preferably having a lactide content of 20-75 mol %, more preferably 55-70 mol %, most preferably 62-69 mol %.

7. Drain according to claim 6, wherein the fraction of the L-enantiomer or the D-enantiomer of the lactide is from 65-95_mol %, preferably from 70-90 mol %, more preferably about 85 mol %.

8. Drain according to claim 4, wherein the polyester, polyester-carbonate and/or polyanhydride is a segmented or block copolymer with randomly or alternating segments or blocks and consisting of at least two blocks with different composition.

9. Drain according to claim 8, wherein the segments or blocks are phase separated hard and soft segments, characterized by at least two phase transitions, one of them being a glass transition temperature lower than 37°

C., the other a glass transition temperature or melting temperature higher than 37°

C.

10. Drain according to claim 8, wherein the segments or blocks forming the low temperature transition phase are composed of pre-polymers of (mixtures of) cyclic or non-cyclic monomers lactide, glycolide, ε

-caprolactone, δ

-valerolactone, trimethylenecarbonate, tetramethylenecarbonate, 1,5-dioxepane-2-one, para-dioxanone and/or hydroxyalkanoicacid.

11. Drains according to claim 8, wherein the copolymer or pre-polymers are obtained by a ring opening polymerization initiated by a diol or di-acid compound.

12. Drains according to claim 8, wherein the pre-polymers forming the segments are linked by a difunctional aliphatic compound, preferably a diisocyanate, more preferably 1,4-butanediisocyanate.

13. Drain according to claim 9, wherein the segment or block with highest temperature phase transition (hard segment or block) is formed by poly-caprolactone, poly-valerolactone, poly-lactide, poly(lactide-glycolide), poly-para-dioxanone, poly(hydroxybutyricacid), polysebacic acid, poly(dodecanedioicanhydride) pre-polymers, and combinations thereof.

14. Drain according to claim 4, wherein the biodegradable polymer comprises a polyurethane, which biodegradable polymer is a phase separated copolymer with a polyester, polyester-carbonate and/or polycarbonate soft segment and a urethane hard segment with uniform block length.

15. Drain according to claim 14, wherein the polyurethane is formed by diisocyanate linked pre-polymer and diol components having the formula [-A-B-C-B-]n, wherein A denotes the pre-polymer moiety, B denotes the diisocyanate moiety, C denotes the diol moiety, having a uniform block length;

and n represents an integer larger than 1.

16. Drain according to claim 15, wherein the diol component is a linear aliphatic diol (X) with general structure HO—

(CH₂)_n-OH with n=2-8 or HO—

(CH₂CH₂—

O—

CH₂CH₂)_n-OH with n=2-8 or the diol (XYX) is a reaction product of two moles of the diol (X) with said diisocyanate.

17. Drain according to claim 15, wherein the diisocyanate is 1,4-butanediisocyanate.

18. Drain according to claim 15, wherein the pre-polymer is formed by ring opening polymerization initiated by a diol or polyethyleneglycol compound of the cyclic monomers lactide, glycolide, ε

-caprolactone, δ

-valerolactone, trimethylenecarbonate, tetramethylenecarbonate, 1,5-dioxepane-2-one and/or para-dioxanone.

19. Drain according to claim 14, wherein the polyester is a poly(DL-lactide-ε

-caprolactone) and the diol compound is the reaction product of two moles of 1,4-butanediol and one mole of 1,4-butanediisocyanate.

20. Drain according to claim 14, wherein the polyester is a poly(DL-lactide-ε

-caprolactone) and the diol compound is the reaction product of two moles of diethyleneglycol and one mole of 1,4-butanediisocyanate.

21. Drain according to claim 14, wherein the soft segment is a combination of a pre-polymer with a polyether pre-polymer, preferably a polyethyleneglycol.

22. Drain according to claim 21 wherein the polyethyleneglycol has a molecular weight of 1500.

23. Drain according to claim 14, wherein the polyurethane contains 1-25 wt. % polyethyleneglycol, preferably 5-15%, being present as a pre-polymer initiator, and the polyester is a poly(DL-lactide-ε

-caprolactone) and the diol compound is the reaction product of two moles of 1,4-butanediol and one mole of 1,4-butanediisocyanate.

24. Drain according to claim 23, wherein the polyethyleneglycol has a molecular weight of 1000.

25. Drain according to claim 1, wherein the polymer comprises a polyurethane and a polyester, polyestercarbonate or a polycarbonate, obtainable by solution blending.

26. Drain according to claim 25, wherein the polyurethane is based on a DL-lactide-ε

-caprolactone soft segment pre-polymer and the polyester is a poly(DL-lactide-ε

-caprolactone) copolymer.

27. Drain according to claim 1, wherein said polymer is loaded with radiopaque fillers and/or pharmaceutical components such as antibiotics, anti-inflammatory agents, peptides and proteins.

28. Drain according to claim 1, which is provided with perforations.

29. Nasal drain according claim 1.

30. Drain, particularly a nasal drain, according to claim 1, having a wall thickness of 0.05-5.0 mm.

31. Drain according to claim 1, having a total length of 3-300 mm.

32. Drain according to claim 1, having an outer diameter of 0.5-50 mm.

33. Drain according to claim 1, comprising a funnel shaped element on at least one end.

34. Drain according to claim 33, having a funnel length of 2-20 mm and preferably a funnel diameter of 3-30 mm.

35. Drain according to claim 1, which is obtainable by dip-coating or spray coating of a polymer solution on a mandrel or extrusion of a polymer.

36. Use of a drain according to claim 21 used for performing coloanal anastomosis.

37. Method for treating a disorder associated with dysfunction of natural drainage of body fluids from an antrum, organ or tissue comprising introducing a drain according to claim 1 in said antrum, organ or tissue, such that said antrum, organ or tissue is connected with the environment or another location within the body, after which said drain degrades over time and degradation products of said drain are cleared through the digestive channel and/or said antrum, organ or tissue and/or absorbed and subsequently metabolized and/or secreted by the body.

38. Method according to claim 37, wherein said disorder is selected from (chronic) sinusitis, inflammation of the middle ear, liver disorders, disorders of the gastro-intestinal tract, tear duct disorder, surgical wound drainage, and thoracic disorder.

39. Method according to claim 37, wherein said drain is introduced in said antrum using at least one of:

sealant;

suture; and

staple.

40. Use of a drain according to claim 1 in the preparation of a medicament or kit for the treatment of a disorder as defined in claim 37.