Method of making blood gas sensors overcoats using permeable polymeric compositions

• US 5,670,097 A
• Filed: 12/08/1994
• Issued: 09/23/1997
• Est. Priority Date: 12/08/1994
• Status: Expired due to Fees

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: 3M Company
• Inventors: Howard, William L. Jr., Wood, Kenneth B., Duan, Daniel C., Fogarty, Terence M., Schaberg, Mark S.
• Primary Examiner(s): Vargot, Mathieu D.
• Application Number:
  US08/351,771
• Time in Patent Office: 1,020 Days
• Field of Search: 264/1.1, 264/1.24, 264/1.6, 264/232, 264/233, 264/2.6, 264/272.11, 264/272.15, 264/272.16, 427/162, 427/163.2, 385/12, 422/68.1, 128/634, 128/637
• US Class Current: 264/1.24
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters

Abstract

The present invention provides a shaped permeable polymeric material including a hydrophobic portion and a hydrophilic portion, wherein the material is crosslinked. This material is prepared by a method including the steps preparing a crosslinkable composition having a hydrophobic portion and a hydrophilic portion; placing the crosslinkable composition in a mold; gelling the crosslinkable composition to form a shaped gelled polymeric composition comprising a hydrophobic portion, a hydrophilic portion, and a liquid portion; and exchanging the liquid portion with an exchange liquid to form the permeable polymeric material. Preferably this material is used in a blood gas sensor.

Claims

1. A method for making a shaped permeable polymeric material, the method comprising:

(a) preparing a crosslinkable composition comprising a hydrophobic portion and a hydrophilic portion, wherein the hydrophobic portion is a polymeric material selected from the group consisting of a polysulfone, a polyethersulfone, a polyarylsulfone, a polyimide, a polyarylate, a cellulose acetate, a polyurethane, a polycarbonate, a polyester carbonate a phenoxy resin, a polyether imide, a cellulose acetate butyrate, a nylon, a polyvinyl butyral, a polyarylene oxide, a poly(urea urethane), a polyphenyl quinoxaline, and mixtures thereof;

(b) placing the crosslinkable composition in a mold;

(c) gelling the crosslinkable composition to form a shaped gelled composition comprising a hydrophobic portion, a hydrophilic portion, and a liquid portion; and

(d) exchanging the liquid portion with an exchange liquid to form a shaped permeable polymeric material having a tensile strength, when fully hydrated, of at least about 525 psi (3620 kPa).

2. The method of claim 1 wherein the step of gelling the crosslinkable composition is carded out in an oxygen-reduced environment.

3. The method of claim 1 further including a step of exposing the shaped gelled polymeric composition to a humid atmosphere prior to the step of exchanging the liquid portion with an exchange liquid.

4. The method of claim 1 wherein the mold is presoaked prior to placing the crosslinkable composition in the mold.

5. The method of claim 1 wherein the crosslinkable composition further includes a crosslinking agent.

12. The method of claim 1 wherein the hydrophilic portion of the crosslinkable composition comprises a hydrophilic monomeric material and the step of gelling comprises polymerizing at least a portion of the monomeric material and crosslinking the composition to form the shaped gelled composition.

13. The method of claim 12 wherein the liquid portion comprises an organic solvent.

14. The method of claim 1 wherein the hydrophobic and hydrophilic portions of the crosslinkable composition are part of a semihydrophilic polymer.

15. The method of claim 1 wherein the exchanging step comprises contacting the shaped gelled composition with a vapor of the exchange liquid.

31. The method of claim 1, wherein the method further includes a step of placing a portion of a blood gas sensor in the mold, and wherein the shaped permeable polymeric material is coated on the sensor.

36. The method of claim 5 wherein the permeable polymeric material has a tensile strength, when fully hydrated, of at least about 800 psi.

37. The method of claim 5 wherein the crosslinking agent comprises diallyl maleate.

6. A method for making a coated blood gas sensor, the method comprising:

(a) preparing a crosslinkable composition comprising a hydrophobic portion and a hydrophilic portion, wherein the hydrophobic portion of the crosslinkable composition comprises a hydrophobic polymeric material;

(b) placing the crosslinkable composition and a portion of the sensor in a mold;

(c) gelling the crosslinkable composition to form a shaped gelled composition comprising a hydrophobic portion, a hydrophilic portion, and a liquid portion; and

(d) exchanging the liquid portion with an exchange liquid to form a shaped permeable polymeric material coated on the sensor having a tensile strength, when fully hydrated, of at least about 650 psi (4482 kPa).

7. The method of claim 6 wherein the hydrophilic portion of the crosslinkable composition comprises a hydrophilic monomeric material and the step of gelling comprises polymerizing at least a portion of the hydrophilic monomeric material and crosslinking the composition to form the shaped gelled composition.

8. The method of claim 7 wherein the liquid portion comprises an organic solvent.

9. The method of claim 7 wherein the hydrophilic monomeric material comprises N-vinyl pyrrolidone and the hydrophobic polymeric material comprises polyurethane or poly(urea urethane).

10. The method of claim 6 wherein the hydrophilic portion of the crosslinkable composition comprises a hydrophilic polymeric material and the step of gelling comprises crosslinking at least a part of the hydrophobic or hydrophilic polymeric materials.

11. The method of claim 10 wherein the liquid portion comprises an organic solvent.

32. The method of claim 7, wherein the method further includes a step of placing a portion of a blood gas sensor in the mold, and wherein the shaped permeable polymeric material is coated on the sensor.

33. The method of claim 9, wherein the method further includes a step of placing a portion of a blood gas sensor in the mold, and wherein the shaped permeable polymeric material is coated on the sensor.

16. A method for making a shaped permeable polymeric material, the method comprising:

(a) preparing a crosslinkable composition comprising a hydrophobic polymeric material, a hydrophilic monomeric material, and an organic solvent, wherein the hydrophobic polymeric material is selected from the group consisting of a polysulfone, a polyethersulfone, a polyarylsulfone, a polyimide, a polyarylate, a cellulose acetate, a polyurethane, a polycarbonate, a polyester carbonate, a phenoxy resin, a polyether imide, a cellulose acetate butyrate, a nylon, a polyvinyl butyral, a polyarylene oxide, a poly(urea urethane), a polyphenyl quinoxaline, and mixtures thereof;

(b) placing the crosslinkable composition in a mold;

(c) gelling the crosslinkable composition to form a shaped gelled composition comprising a hydrophobic portion, a hydrophilic portion, and a liquid portion; and

(d) exchanging the liquid portion with an exchange liquid to form a shaped permeable polymeric material having a tensile strength, when fully hydrated, of at least about 525 psi (3620 kPa).

17. The method of claim 16 wherein the organic solvent is selected from the group consisting of N-methyl pyrrolidone, N,N-dimethyl formamide, and N,N-dimethyl acetamide.

18. The method of claim 16 wherein the crosslinkable composition further includes a crosslinking agent.

19. The method of claim 18 wherein the crosslinkable composition further includes an initiator.

20. The method of claim 16 wherein the hydrophilic monomeric material of the crosslinkable composition is selected from the group consisting of N-vinyl pyrrolidone, N,N-dimethyl acrylamide, N-vinyl-N-methyl acetamide, N-vinyl valerolactam, N-vinyl caprolactam, acrylamide, acrylic acid, hydroxy ethyl acrylate, hydroxy ethyl methacrylate, poly(ethylene glycol) methyl ether acrylate, and mixtures or copolymers thereof.

21. The method of claim 20 wherein the hydrophilic portion of the crosslinkable composition comprises N-vinyl pyrrolidone and the hydrophobic portion of the crosslinkable composition comprises poly(urethane) or poly(urea urethane).

34. The method of claim 20, wherein the method further includes a step of placing a portion of a blood gas sensor in the mold, and wherein the shaped permeable polymeric material is coated on the sensor.

38. The method of claim 16 wherein the permeable polymeric material has a tensile strength, when fully hydrated, of at least about 800 psi.

22. A method for making a shaped permeable polymeric material, the method comprising:

(a) preparing a crosslinkable composition comprising a hydrophobic portion and a hydrophilic portion, wherein the hydrophobic portion is a polymeric material selected from the group consisting of a polysulfone, a polyethersulfone, a polyarylsulfone, a polyimide, a polyarylate, a cellulose acetate, a polyurethane, a polycarbonate, a polyester carbonate, a phenoxy resin, a polyether imide, a cellulose acetate butyrate, a nylon, a polyvinyl butyral, a polyarylene oxide, a poly(urea urethane), a polyphenyl quinoxaline, and mixtures thereof;

(b) placing the crosslinkable composition in a mold;

(c) gelling the crosslinkable composition to form a shaped gelled composition comprising a hydrophobic portion, a hydrophilic portion, and a liquid portion;

(d) evaporating the liquid portion; and

(e) adding an exchange liquid to form a shaped permeable polymeric material having a tensile strength, when fully hydrated, of at least about 525 psi.

23. The method of claim 22 wherein the crosslinkable composition further includes an organic solvent.

24. The method of claim 23 wherein the hydrophilic portion of the crosslinkable composition comprises N-vinyl pyrrolidone and the hydrophobic portion of the crosslinkable composition comprises poly(urethane) or poly(urea urethane).

35. The method of claim 24, wherein the method further includes a step of placing a portion of a blood gas sensor in the mold, and wherein the shaped permeable polymeric material is coated on the sensor.

25. A method for making a coated blood gas sensor, the method comprising:

(a) preparing a crosslinkable composition comprising a hydrophobic portion and a hydrophilic portion;

(b) placing the crosslinkable composition and a portion of the sensor in a mold;

(c) gelling the crosslinkable composition to form a shaped gelled composition comprising a hydrophobic portion, a hydrophilic portion, and a liquid portion; and

(d) exchanging the liquid portion with an exchange liquid to form a shaped permeable polymeric material coated on the sensor having a tensile strength, when fully hydrated, of at least about 525 psi.

26. The method of claim 25 wherein the blood gas sensor comprises a pH sensor, a CO₂ sensor, and an O₂ sensor.

27. The method of claim 25 wherein the gelling step is performed in an oxygen-reduced environment.

28. The method of claim 25 wherein the crosslinkable composition further includes an organic solvent.

29. The method of claim 28 wherein the hydrophobic portion of the crosslinkable composition is selected from the group consisting of a polysulfone, a polyethersulfone, a polyarylsulfone, a polyimide, a polyarylate, a cellulose acetate, a polyurethane, a polycarbonate, a polyester carbonate, a phenoxy resin, a silicone, a polyether imide, a cellulose acetate butyrate, a nylon, a polyvinyl butyral, a polyarylene oxide, a poly(urea urethane), a polyphenyl quinoxaline, and mixtures thereof.

30. The method of claim 29 wherein the hydrophilic portion of the crosslinkable composition is selected from the group consisting of N-vinyl pyrrolidone, N,N-dimethyl acrylamide, N-vinyl-N-methyl acetamide, N-vinyl valerolactam, N-vinyl caprolactam, acrylamide, acrylic acid, hydroxy ethyl acrylate, hydroxy ethyl methacrylate, poly(ethylene glycol) methyl ether acrylate, and mixtures or copolymers thereof.

39. A method for making a coated blood gas sensor, the method comprising:

(a) preparing a crosslinkable composition comprising a hydrophobic portion selected from the group consisting of a polysulfone, a polyethersulfone, a polyarylsulfone, a polyimide, a polyarylate, a cellulose acetate, a polyurethane, a polycarbonate, a polyester carbonate, a phenoxy resin, a silicone, a polyether imide, a cellulose acetate butyrate, a nylon, a polyvinyl butyral, a polyarylene oxide, a poly(urea urethane), a polyphenyl quinoxaline, and mixtures thereof, and a hydrophilic portion selected from the group consisting of N-vinyl pyrrolidone, N,N-dimethyl acrylamide, N-vinyl-N-methyl acetamide, N-vinyl valerolactam, N-vinyl caprolactam, acrylamide, acrylic acid, hydroxy ethyl acrylate, hydroxy ethyl methacrylate, poly(ethylene glycol) methyl ether acrylate, and mixtures or copolymers thereof;

(b) placing the crosslinkable composition and a portion of the sensor in a mold;

(c) gelling the crosslinkable composition to form a shaped gelled composition comprising a hydrophobic portion, a hydrophilic portion, and a liquid portion; and

(d) exchanging the liquid portion with an exchange liquid to form a shaped permeable polymeric material coated on the blood gas sensor.