Injection and hemostasis site

• US 20070066926A1
• Filed: 09/14/2006
• Published: 03/22/2007
• Est. Priority Date: 09/16/2004
• Status: Active Grant

• Current Assignee: Lifestream Medical Corporation
• Original Assignee: Lifestream Medical Corporation
• Inventors: Bell, David, Schnell, William, Utterberg, David
• Granted Patent: US 8,592,639 B2
• Time in Patent Office: Days
• US Class Current: 602/58
• CPC Class Codes: A61F 13/0203 with fluid retention members
• CPC Class Codes: A61F 2013/00417 pierced by needle
• CPC Class Codes: A61F 2013/00468 applying local pressure

Abstract

A pad of elastomeric material having a softness of typically no more than about durometer 50 Shore 00. The pad may carry adhesive and/or a housing for adhering the pad to a surface, either manually, or by adhesive tape, or another strap. Such a pad exhibits hemostatic and leak prevention properties against needle puncture holes in the skin or the wall of a hollow medical device. Particularly, hemostasis may be prevented with low pressure application of the pad to the skin. The pad may be previously applied to the skin of the patient or a wall of a medical device such as tubing or a solution bag, and the needle may then penetrate both the pad and the skin or medical device wall, to make a resealable puncture with leakage reduction and hemostasis when the needle is withdrawn.

Claims

1. The method which comprises:

applying a soft pad to the skin of a patient, said pad consisting essentially of an elastomer having a hardness of no more than about durometer 50 Shore 00;

passing a medical needle through the pad into the tissue of the patient; and

thereafter withdrawing said needle, whereby bleeding is substantially suppressed.

2. A soft, pad of elastomeric material having a hardness of no more than about durometer 50 Shore 00, said pad carrying a strap member for adhering the pad to a surface, whereby bleeding or leakage through the skin of a patient or a wall of a hollow medical device may be suppressed.

3. The pad of claim 2 in which said elastomeric material has an elongation to break of at least 500 percent.

4. The pad of claim 3 in which the hardness of said elastomeric material no more than about durometer 30 Shore 00.

5. The pad of claim 2, in which said strap member is adhesive tape.

6. The pad of claim 2 which is packaged in sterile condition.

7. The pad of claim 2 in which the elongation to break of said elastomer is about 900% to 1000%.

8. The pad of claim 2 which has at least one smooth face for contact with the patient.

9. A flexible, elastomeric hemostasis pad having a non-porous surface for use in preventing bleeding, said pad having a hardness of no more than about durometer 50 Shore 00.

10. The pad of claim 9 in which the hardness of the pad is no more than durometer 30 Shore 00.

11. The pad of claim 9 in which the pad is made of an elastomeric material which has an elongation to break of at least five hundred percent.

12. The pad of claim 9 in which the pad is packaged in sterile condition.

13. The pad of claim 9 which is substantially transparent.

14. The pad of claim 9 which has an upper surface with a raised profile, said pad being secured to patient'"'"'s skin by adhesive tape or other strap extending over said upper surface.

15. The method which comprises:

inserting a hollow cannula through a point in the skin of a patient;

thereafter placing a soft, elastomeric pad on the skin of the patient to cover with pressure the point of the skin through which the cannula penetrates; and

thereafter removing the cannula, said pad having a hardness of no more than about durometer 50 Shore 00, whereby bleeding is suppressed by the pad.

16. The method of claim 15 in which the soft, elastomeric pad is held against the skin of the patient, with adhesive tape or another strap, and the pad is substantially transparent.

17. The method of claim 16 in which the pad has an upper surface is of a raised profile shape.

18. A soft, nonporous-surfaced pad for hemostasis, said pad having a hardness of no more than about durometer 50 Shore 00, said pad being carried in a recess defined by a recess wall in a plastic sheet, said sheet also having a flat flange at least partially surrounding said recess wall, to be affixed to the skin of a patient, with the recess wall and the patient'"'"'s skin together enclosing the soft pad.

19. The pad and plastic sheet of claim 18 in which said pad and recess wall are of dome shape.

20. The pad and plastic sheet of claim 19 in which a peel-type closure is affixed to the flat flange to enclose the soft pad.

21. The pad and plastic sheet of claim 18 in which the flat flange carries skin adhesive.

22. The pad and plastic sheet of claim 18 in which the hardness of said elastomer no more than about durometer 30 Shore 00.

23. The pad and plastic sheet of claim 18 in which said plastic sheet is made of poly (ethylene-vinyl acetate).

24. The pad and plastic sheet of claim 18 in which said pad has a face that projects outwardly beyond said recess and plastic sheet.

25. A soft, hemostasis pad of elastomeric material having a hardness of no more than about durometer 50 Shore 00, said pad having an upper wall with a raised profile shape, with a flat bottom.

27. The soft, hemostasis pad of claim 25 in which the hardness is no more than about durometer 30 Shore 00.

30. The soft, hemostasis pad of claim 25 which includes a medicament.

31. The soft, hemostasis pad of claim 25 which is transparent.

26. The soft, hemostasis pad of claim 26, said flat bottom resting on the skin of a patient, and a cover sheet extending over the pad and attached to the skin.

28. The soft, hemostasis pad of claim 26, having an elongation to break of at least 500 percent.

29. The pad and plastic sheet of claim 28 in which said elastomer has a tear resistance of at least 800,000 dynes per cm.

32. A soft, elastomeric pad, affixed to the skin of a patient, said pad having a non-porous surface abutting and pressing against the skin of the patient, and having a hardness of no more than about durometer 50 Shore 00;

whereby bleeding is substantially suppressed.

33. The pad of claim 32 in which the hardness of said pad is no more than about durometer 30 Shore 00.

34. A soft, nonporous-surfaced elastomer pad for hemostasis, said pad having a hardness of no more than durometer 30 Shore 0, said pad having a flat face on one side thereof, said pad being carried by a wall on a side opposed to said one side, to permit said flat face of the pad to be pressed against the skin of a patient by pressure on said wall.

35. The pad of claim 34 in which adhesive tape, or another strap, attached to the skin of the patient, presses said flat face of the pad against the skin of the patient.

36. The pad of claim 34 in which the hardness of said pad is no more than about 50 Shore 00.

37. The pad of claim 34 in which said opposed side has a raised profile.

38. The pad of claim 34 which comprises a pair of opposed, parallel, equally sized major faces forming a flat sheet.

39. The pad of claim 34 in which a cannula extends through the pad and the skin of the patient.

40. The pad of claim 34 in which the softness of the pad is about equal to the softness of human skin.