Hydrogel adhesive for attaching medical device to patient

• US 5,665,477 A
• Filed: 06/07/1995
• Issued: 09/09/1997
• Est. Priority Date: 04/04/1994
• Status: Expired due to Term

• Current Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Original Assignee: Graphic Controls Corporation (Nissha Co., Ltd.)
• Inventors: Meathrel, William G., Saleem, Mohammad, Binks, Shirley A.
• Primary Examiner(s): Lovering, Richard D.
• Application Number:
  US08/487,806
• Time in Patent Office: 825 Days
• Field of Search: 128/640, 252/315.4, 252/518, 522/42, 523/177, 524/916, 526/317.1, 427/516, 427/207.1, 427/2.12, 428/500
• US Class Current: 428/500
• CPC Class Codes: A61B 5/252 by suction
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: Y10S 524/916 Hydrogel compositions
• CPC Class Codes: Y10T 428/31692 Next to addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31855 Of addition polymer from unsaturated monomers

Abstract

A biocompatible hydrogel adhesive which is prepared from a precursor containing acrylic acid and an alcoholamine and is adhesive under both wet and dry conditions. The use of diisopropanolamine provides these unexpected and unique wet tack properties and permits adhesion to wet tissue. Additionally, the use of a polyol which contains hydroxyl groups, such as glycerine, and a diamine, such as 2-methylpentamethylenediamine, is found to provide a hydrogel having wet adhesive properties and longer shelf life. The hydrogel adhesive can be used as an attachment means in conjunction with a biomedical detection or monitoring means. The adhesive may be used to attach a sensor on the skin of an intrautero fetus and to monitor the well being of the fetus during labor and delivery. The hydrogel having wet adhesive properties permits the attachment of a sensor or sensors onto wet tissue. The biocompatible adhesive is used to attach a fetal probe securely to a fetus. The adhesive can be used as an attachment means for a drug delivery or prosthetic device or as an attachment means for fixing a contraceptive device to the wall of the uterus. The attachment means could also be used in the oral cavity to fix a sensor or for oral therapies.

Claims

1. In a process for producing a medical device attaching to a patient, the improvement comprising the steps of:

applying a coating of a precursor composition comprising acrylic acid monomer and an alcoholamine to said medical device; and

polymerizing said precursor composition to produce a hydrogel which is adhesive under both wet and dry conditions.

2. A process as recited in claim 1 wherein said alcoholamine is diisopropanolamine.

3. A process as recited in claim 2 wherein said device is a fetal pulse oximeter sensor attaching to a presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery.

4. A process as recited in claim 2 wherein said precursor further comprises water, a photoinitiator, and a crosslinking agent.

5. A process as recited in claim 4 wherein said device is a fetal pulse oximeter sensor attaching to a presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery.

6. A process as recited in claim 2 wherein said precursor comprises up to about 40% water, up to about 30% acrylic acid, 0.3-0.4% photoinitiator, 0.05-0.20% crosslinking agent, and up to about 30% diisopropanolamine.

7. A process as recited in claim 6 wherein said precursor comprises about 29% water, about 25% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.10% polyethylene glycol (400) diacrylate, and about 24% diisopropanolamine.

8. A process as recited in claim 6 wherein said precursor comprises about 39% water, about 29% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.10% polyethylene glycol diacrylate, and about 28% diisopropanolamine.

9. A process as recited in claim 6 wherein said precursor comprises about 35% water, about 18% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.10% polyethylene glycol (400) diacrylate, and about 30% diisopropanolamine.

10. A process as recited in claim 6 wherein said precursor comprises about 39% water, about 16% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.15% polyethylene glycol (400) diacrylate, about 28% diisopropanolamine, and about 13.0% vinyl pyrrolidone.

11. A process as recited in claim 6 wherein said precursor comprises about 25% water, about 19% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.10% polyethylene glycol (400) diacrylate, and about 8% diisopropanolamine.

12. A process as recited in claim 6 wherein said precursor comprises about 11% water, about 22% acrylic acid, about 0.33% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.17% polyethylene glycol (400) diacrylate, and about 14% diisopropanolamine.

13. A process as recited in claim 6 wherein said precursor comprises about 38% water, about 16% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.15% polyethylene glycol (400) diacrylate, about 28% diisopropanolamine, and about 13% vinyl pyrrolidone.

14. A process as recited in claim 6 wherein said device is a fetal pulse oximeter sensor attaching to a presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery.

15. A process as recited in claim 1 wherein said hydrogel is conductive.

16. A process as recited in claim 1 wherein said device is a non-invasive fetal probe attaching to a presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery, said probe comprising:

a body having a surface adapted for securing the probe to the fetus to be monitored, said body comprised of said hydrogel which is adhesive under both wet and dry conditions;

a sensor carried by said body and detecting at least one fetal parameter; and

means for communicating the fetal parameter detected by said sensor from said sensor to a monitor.

17. A process as recited in claim 16 wherein said body of said non-invasive fetal probe has a diameter of 10-20 mm.

18. A process as recited in claim 16 wherein said body of said non-invasive fetal probe is comprised entirely of said hydrogel.

19. A process as recited in claim 16 wherein said body of said non-invasive fetal probe further comprises a shell, and said hydrogel is coated on said shell and forms said concave surface of said body facing the fetus.

20. A process as recited in claim 19 wherein said shell of said non-invasive fetal probe is polymeric.

21. A process as recited in claim 19 wherein said shell of said non-invasive fetal probe has an outer perimeter forming a member which is one of a ledge and a ridge isolating said hydrogel from fluids in the environment surrounding the probe.

22. A process as recited in claim 21 wherein said member formed by said outer perimeter of said shell is a ridge having a top edge and a lower edge and wherein said hydrogel extends to said top edge of said ridge.

23. A process as recited in claim 21 wherein said member formed by said outer perimeter of said shell is a ledge having a side surface, a top surface, and a bottom surface and wherein said hydrogel is disposed on said top surface.

24. A process as recited in claim 1 wherein said device is a fetal pulse oximeter sensor attaching to a presenting part of a fetus and monitoring at least one fetal parameter during labor and delivery.

25. A process as recited in claim 24 wherein said hydrogel is a suction cup.

26. The product produced by the process recited in claim 1.

27. A process for producing a hydrogel adhesive comprising the steps of:

providing a precursor composition comprising acrylic acid monomer and an alcoholamine; and

polymerizing said precursor composition to produce a water-insoluble hydrogel adhesive which is adhesive under both wet and dry conditions.

28. A process as recited in claim 27 wherein said alcoholamine is diisopropanolamine.

29. The product produced by the process recited in claim 27.

30. A process for producing a hydrogel adhesive comprising the steps of:

providing a precursor composition comprising acrylic acid, diisopropanolamine, water, a photoinitiator, and a crosslinking agent; and

polymerizing said precursor composition to produce a hydrogel adhesive which is adhesive under both wet and dry conditions.

31. A process as recited in claim 30 wherein said precursor further comprises an electrolyte.

32. A process for producing a hydrogel adhesive comprising the steps of:

providing a precursor composition comprising up to about 40% water, up to about 30% acrylic acid, 0.3-0.4% photoinitiator, 0.05-0.20% crosslinking agent, and up to about 30% diisopropanolamine; and

polymerizing said precursor composition to produce a hydrogel adhesive which is adhesive under both wet and dry conditions.

33. A process as recited in claim 32 wherein said precursor comprises about 29% water, about 25% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.10% polyethylene glycol (400) diacrylate, and about 24% diisopropanolamine.

34. A process as recited in claim 32 wherein said precursor comprises about 39% water, about 29% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.10% polyethylene glycol (400) diacrylate, and about 28% diisopropanolamine.

35. A process as recited in claim 32 wherein said precursor comprises about 35% water, about 18% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.10% polyethylene glycol (400) diacrylate, and about 30% diisopropanolamine.

36. A process as recited in claim 32 wherein said precursor comprises about 39% water, about 16% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.15% polyethylene glycol (400) diacrylate, about 28% diisopropanolamine, and about 13.0% vinyl pyrrolidone.

37. A process as recited in claim 32 wherein said precursor comprises about 25% water, about 19% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.10% polyethylene glycol (400) diacrylate, and about 8% diisopropanolamine.

38. A process as recited in claim 32 wherein said precursor comprises about 11% water, about 22% acrylic acid, about 0.33% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.17% polyethylene glycol (400) diacrylate, and about 14% diisopropanolamine.

39. A process as recited in claim 32 wherein said precursor comprises about 38% water, about 16% acrylic acid, about 0.35% 2-hydroxy-2-methyl-1-phenyl-propane-1-one, about 0.15% polyethylene glycol (400) diacrylate, about 28% diisopropanolamine, and about 13% vinyl pyrrolidone.