Polymeric article having high tensile energy to break when hydrated

• US 4,883,699 A
• Filed: 01/23/1987
• Issued: 11/28/1989
• Est. Priority Date: 09/21/1984
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Menlo Care, Inc. (Johnson & Johnson)
• Inventors: Aniuk, Lawrence M., Dieck, Ronald L., Hardy, Dwayne
• Primary Examiner(s): Jacobs, Lewis T.
• Assistant Examiner(s): WOODWARD, ANA LUCRECIA
• Application Number:
  US07/008,117
• Time in Patent Office: 1,040 Days
• Field of Search: 523/113, 523/115, 523/106, 525/57, 525/409, 525/453, 525/937, 428/36.9
• US Class Current: 428/36.9
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: C08L 101/00 Compositions of unspecified macromolecular compounds
• CPC Class Codes: C08L 2203/02 for biomedical use
• CPC Class Codes: C08L 2666/02 Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: Y10S 525/937 Utility as body contact e.g. implant, contact lens or I.U.D.
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article

Abstract

An article, suitable for use as a body implant, is made from a novel composition comprising a multiple phase polymer composition comprising:

(a) a first phase which comprises a substantially non-hydrophilic polymeric component; and

(b) a second phase which comprises a hydrophilic polymeric component;

said composition (i) being capable of absorbing water to an extent that it softens with a softening ratio of at least about 2:1 and/or swells with a swelling ratio of at least about 1.3:1; and (ii) when substantially completely hydrated has an energy to break of at least about 700 N-cm/cm³ and a 2.5% Secant modulus of less than about 7,000 N/cm².

Claims

1. An article, suitable for use as a body implant, having been formed from a multiple phase polymeric composition comprising:

(a) a first phase which is continuous and comprises a substantially non-hydrophilic polymeric component capable of absorbing water in an amount of no more than about 30% by weight based on the weight of the non-hydrophilic polymer; and

(b) a second phase which comprises a hydrophilic polymeric component capable of absorbing at least about 50% water, by weight based on the weight of the hydrophilic polymer;

wherein said article (i) is capable of absorbing water to an extent that it softens with a softening ratio of at least about 2;

1 or swells with a swelling ratio of at least about 1.3;

1; and

(ii) has an energy to break of at least about 700 N-cm/cm³ and a 2.5% Secant modulus of less than about 7,000 N/cm², when substantially completely hydrated.

2. An article in accordance with claim 1, wherein said second phase is dispersed in said continuous first phase.

3. An article in accordance with claim 1, wherein said non-hydrophilic polymer component comprises a polyurethane an ethylene-vinyl acetate copolymer, an ethylene-ethyl acrylate copolymer, a low crystalline polyamide or an aliphatic polyester.

4. An article in accordance with claim 3, wherein the non-hydrophilic polymer component comprises a polyurethane.

5. An article in accordance with claim 1, wherein the hydrophilic polymeric component comprises polyvinyl alcohol, poly(ethylene oxide), polypropylene oxide, poly(ethylene glycol), polypropylene glycol, polytetramethylene oxide polyvinyl propylidene, polyacrylamide, poly(hydroxy ethyl acrylate) or poly(hydroxyethyl methacrylate).

6. An article in accordance with claim 5, wherein the hydrophilic polymeric component comprises poly(ethylene oxide).

7. An article in accordance with claim 1, wherein said multiple phase composition comprises a physical mixture of said polymeric components.

8. An article in accordance with claim 1, wherein said composition position is crosslinked.

9. An article in accordance with claim 1, wherein the composition position has a softening ratio of at least about 6:

1.

10. An article in accordance with claim 1, wherein the composition position has a softening ratio of at least about 10:

1.

11. An article in accordance with claim 1, wherein the composition has a swelling ratio of at least about 1.7:

1.

12. An article in accordance with claim 1, wherein the composition has a swelling ratio of at least about 2.0:

1.

13. An article in accordance with claim 1, wherein the composition has a energy to break of at least about 1400 N-cm/cm³.

14. An article in accordance with claim 1, wherein the composition has a 2.5% Secant modulus when hydrated of less than about 4,000 N/cm².

15. An article in accordance with claim 1, which is a tubular article, the walls of which are made of said composition.

16. An article in accordance with claim 15, which is a catheter or cannula.

17. An tubular article suitable for use as a catheter or cannula the walls of which have been formed from a multiple phase polymeric composition comprising a physical mixture of:

(a) a first phase which is continuous and comprises a substantially non-hydrophilic polymeric component capable of absorbing water in an amount of no more than about 30% by weight based on the weight of the non-hydrophilic polymer; and

(b) a second phase which comprises a hydrophilic polymeric component capable of absorbing at least about 50% water, by weight based on the weight of the hydrophilic polymer;

wherein said article (i) is capable of absorbing water to an extent that it softens with a softening ratio of at least about 2;

1 a swelling ratio of at least about 1.3;

1; and

(ii) has an energy to break of at least about 700 N-cm/cm³ and a 2.5% Secant modulus of less than about 7,000 N/cm², when substantially completely hydrated.

18. A tubular article in accordance with claim 17, wherein said non-hydrophilic polymeric component comprises a polyurethane.

19. A tubular article in accordance with claim 17, wherein said hydrophilic component comprises polyethylene oxide.

20. An article suitable for use as a body implant, having been formed from a multiple phase polymeric composition comprising:

(a) a first phase which is continuous and comprises a substantially non-hydrophilic polyurethane; and

(b) a second phase which comprises a hydrophilic polyethylene oxide;

wherein said article (i) is capable of absorbing water to an extent that it softens with a softening ratio of at least about 2;

1 or swells with a swelling ratio of at least about 1.3;

1; and

(ii) has an energy to break of at least about 700 N-cm/cm³ and a 2.5% Secant modulus of less than about 7,000 N/cm², when substantially completely hydrated.

21. An article in accordance with claim 20, wherein said second phase is dispersed in said continuous first phase.

22. An article in accordance with claim 21, wherein said multiple phase composition comprises a physical mixture of said polymeric components.

23. An article in accordance with claim 22, wherein said composition is crosslinked.

24. An article in accordance with claim 20, wherein the composition has a softening ratio of at least about 6:

1.

25. An article in accordance with claim 20, wherein the composition has a softening ratio of at least about 10:

1.

26. An article in accordance with claim 20, wherein the composition has a swelling ratio of at least about 1.7:

1.

27. An article in accordance with claim 20, wherein the composition has a swelling ratio of at least about 2.0:

1.

28. An article in accordance with claim 20, wherein the composition has a energy to break of at least about 1400 N-cm/cm³.

29. An article in accordance with claim 20, wherein the composition has a 2.5% Secant modulus when hydrated of less than about 4,000 N/cm².

30. A tubular article suitable for use as a catheter or cannular the walls of which have been formed from a multiple phase polymeric composition comprising a physical mixture of:

(a) a first phase which is continuous and comprises a substantially non-hydrophilic polyurethane; and

(b) a second phase which comprises a hydrophilic polyethylene oxide;

wherein said article (i) is capable of absorbing water to an extent that it softens with a softening ratio of at least about 2;

1 or swells with a swelling ratio of at least about 1.3;

1; and

(ii) has an energy to break of at least about 700 n-cm/cm³ and a 2.5% Secant modulus of less than about 7,000 N/cm², when substantially completely hydrated.