Injection and hemostasis site

• US 8,017,826 B2
• Filed: 09/16/2004
• Issued: 09/13/2011
• Est. Priority Date: 09/16/2004
• Status: Expired due to Fees

• Current Assignee: Lifestream Medical Corporation
• Original Assignee: DSU Medical Corporation
• Inventors: Schnell, William J., Utterberg, David S.
• Primary Examiner(s): Lewis; Kim M
• Application Number:
  US10/943,106
• Publication Number:
  US 20070083138A1
• Time in Patent Office: 2,553 Days
• Field of Search: 604/304, 604/180, 604/174, 602/53, 602/52, 602 41- 43, 433/2, 433/8, 433/22
• US Class Current: 602/53
• CPC Class Codes: A61F 13/0243 characterised by the properties of the skin contacting layer, e.g. air-vapor permeability
• CPC Class Codes: A61F 13/0246 characterised by the skin-adhering layer
• 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 no more than about durometer 30 Shore 00. The pad may carry adhesive for adhering the pad to a surface, either directly or indirectly through an envelope which surrounds the pad and carries the adhesive. 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the skin or medical device wall, to make a resealable puncture with leakage reduction and hemostasis when the needle is withdrawn.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. A method of suppressing bleeding at tissue needle site which comprises:

pressing a soft pad against the skin of a patient, said soft pad being clear for direct visualization of a bleeding site underneath the pad without having to remove the pad, said pad consisting essentially of an elastomer having a hardness of no more than about durometer 30 Shore 0;

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

thereafter withdrawing said needle, whereby bleeding is suppressed by contact of the soft pad against the tissue needle site.

2. The method of claim 1 in which said pad has a thickness of no more than 0.5 cm.

3. The method of claim 1 in which the hardness of said elastomer is no more than durometer 30 Shore 00.

4. The method of claim 1 in which said pad is carried on or in a plastic sheet or envelope, said sheet or envelope carrying a skin adhesive on one side thereof to adhere said pad to the skin of the patient.

5. The method of claim 4 in which said plastic sheet or envelope defines a central opening to expose said pad carried therein.

6. The method of claim 4 in which said plastic envelope has a pair of opposed, major faces, each face defining a central opening to expose said pad carried therein.

7. The method of claim 1 in which said elastomer has a tear resistance of at least 300,000 dynes per square cm.

8. The method of claim 1 in which said pad has a smooth face in contact with the skin.

9. The method of claim 1 in which said pad has a thickness of greater than 0.5 cm.

10. The method of claim 1 in which the pad is substantially free of a compression-providing housing.

11. The method of claim 1 in which the elongation to break of said elastomer is at least about 500%.

12. The method of claim 1 including the step of palpitating a blood vessel under the skin and the pad, to locate a site for said medical needle to pass through the pad into said blood vessel, prior to passing said needle through the pad.

13. The method of claim 12 in which said pad has a durometer of no more than 30 Shore 00, and a thickness of no more than 0.5 cm.

14. The method of claim 1 in which said soft pad presses against the skin with an applied holding pressure of about 25 gm.

15. The method of claim 1 in which the soft pad has a glass-smooth face pressing against the skin.

16. The method of claim 15 in which said soft pad has a raised upper surface relative to other portions thereof.

17. A soft and non-absorbent pad of elastomeric material having a hardness of no more than about durometer 30 Shore 0, said soft pad being clear for direct visualization of a bleeding site underneath the pad without having to remove the pad, said pad carrying an adhesive or a strap member for securing the pad with a surface surrounding the bleeding site, the pad being configured to be pressed against the bleeding site, whereby bleeding or leakage through the skin of a patient or a wall of a hollow medical device is stopped by contact of the pad with the bleeding site.

18. The pad of claim 17 in which said elastomeric material has an elongation to break of at least 500 percent.

19. The pad of claim 18 in which the hardness of said elastomeric material is no more than durometer 30 Shore 00.

20. The pad of claim 19, which pad is carried on or in a plastic sheet or envelope, said sheet or envelope carrying said adhesive on one side thereof to adhere said pad to the skin of a patient or a wall of a hollow medical device.

21. The pad of claim 20 in which said plastic sheet or envelope defines a central opening to expose said pad carried therein.

22. The pad of claim 20 in which said pad carries a strap member which may wrapped around the arm or leg of the patient, for retention of said pad at a site of bleeding or other leakage through the skin of a patient.

23. The pad of claim 17 which has a thickness of less than 0.5 cm.

24. The pad of claim 17 which has length and width each of at least 10 cm.

25. The pad of claim 17 which carries said strap member, and said strap member comprises a pair of straps.

26. The pad of claim 17 in which the elongation to break of said elastomer is about 900% to 1000%.

27. The pad of claim 17 which has at least one glass-smooth face for contact with the patient.

28. The pad of claim 17 which is substantially transparent.

29. The pad of claim 17 in which the elastomeric material contains an effective dosage of vitamin E.

30. The pad of claim 17 which presses against the skin with an applied holding pressure of about 25 gm.

31. The method of claim 17 in which said pad has a raised upper surface relative to other portions thereof.

32. A method of suppressing bleeding from a bleeding site from the skin of a patient, which comprises:

providing a clear, soft and non-absorbent pad of elastomeric material having a hardness, less than about durometer 30 Shore 0; and

suppressing said bleeding, including applying in firm contact with the bleeding site of the patient the clear, soft pad whereby said clear, soft pad permits direct visualization of the bleeding site underneath the pad without having to remove the pad.

33. The method of claim 32 in which said elastomer has an elongation to break of at least 500 percent.

34. The method of claim 33 in which the hardness of said elastomer is no more than durometer 30 Shore 00.

35. The method of claim 34 in which said pad has a thickness of no more than 0.5 cm.

36. The method of claim 32 in which said pad carries a strap member for adhering the pad to the skin.

37. The method of claim 36 in which said pad is carried on or in a plastic sheet or envelope, said sheet or envelope carrying said adhesive on one side thereof to adhere said pad to the skin of a patient during use.

38. The method of claim 37 in which said plastic envelope defines a central opening to expose said pad carried therein to the skin.

39. The method of claim 37 in which said plastic envelope has a pair of opposed major faces, each face defining a central opening to expose said pad carried therein.

40. The method of claim 32 in which said pad has a glass-smooth face in contact with the skin.

41. The method of claim 32 in which said pad has a thickness of greater than 0.5 cm.

42. The method of claim 32 in which said pad has a length and width each of at least 10 cm.

43. The method of claim 32 which further comprises applying a flexible strip over said soft pad on the skin, to apply low force by the pad against the skin to suppress bleeding without pressing shut an underlying vessel.

44. The method of claim 43 in which the hardness of said pad is no more than durometer 30 Shore 00.

45. The method of claim 44, in which said pad is substantially transparent and said strip comprises adhesive tape.

46. The method of claim 43 in which said pad is substantially transparent.

47. The method of claim 32 in which said soft pad presses against the skin with an applied holding pressure of about 25 gm.

48. The method of claim 32 in which said pad has a raised upper surface relative to other portions thereof.

49. A soft, clear and non-absorbent pad for hemostasis of elastomeric material having a hardness of no more than about durometer 30 Shore 0, said pad being configured to be pressed against a wound or cannulation site, whereby bleeding or leakage through the skin of a patient is stopped due to contact of the pad with the wound or cannulation site, and whereby the wound or cannulation site can be directly visualized through the pad without having to remove the pad.

50. The soft pad of claim 49 that has a raised upper surface relative to other portions thereof.

51. The soft pad of claim 50 whereby the pad is manually applied and held against the wound or cannulation site.

52. The soft pad of claim 50 whereby the pad is applied and held against the wound or cannulation site by adhesive tape.

53. The pad of claim 50 in which the pad has a glass smooth face pressing against the skin with an applied holding pressure of about 25 gm.

54. The soft pad of claim 49 whereby the elastomer hardness is no more than about 30 Shore 00.