Injection and hemostasis site

• US 20060079823A1
• Filed: 09/01/2005
• Published: 04/13/2006
• Est. Priority Date: 09/16/2004
• Status: Active Grant

• Current Assignee: Lifestream Medical Corporation
• Original Assignee: Lifestream Medical Corporation
• Inventors: Schnell, William J., Utterberg, David S., Bell, David
• Granted Patent: US 8,450,553 B2
• Time in Patent Office: Days
• 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 50 Shore 00. The pad may carry adhesive and/or a housing 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the skin or medical device wall, to make a resealable puncture with leakage reduction and hemostasis when the needle is withdrawn.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. 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.

26. The method of claim 1 in which said pad is substantially transparent.

2. A soft, pad of elastomeric material having a hardness of no more than about durometer 50 Shore 00, said pad carrying an adhesive or 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 is less than about durometer 30 Shore 00.

5. The pad of claim 2, 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.

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

7. The pad of claim 2, which comprises a pair of opposed, parallel, equally sized major faces forming a flat sheet.

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

9. The pad of claim 2 which has a thickness of less than 0.5 cm.

10. The pad of claim 2 which has length and width each of at least 10 cm.

11. The pad of claim 2 in which said strap member is present and comprises a pair of straps.

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

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

27. The pad of claim 2 which is substantially transparent.

14. The method which comprises:

applying a soft pad to the wall of a hollow medical device, 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 and the wall of said hollow medical device; and

thereafter withdrawing said needle, whereby leakage through a hole formed in the wall of said medical device is suppressed.

15. The method of suppressing bleeding through the skin of a patient, which comprises:

applying to the skin of the patient a soft, nonporous-surfaced pad of material having a hardness of no more than about durometer 50 Shore 00 to suppress said bleeding.

16. The method of claim 15 in which said pad comprises an elastomer which has an elongation to break of at least 500 percent.

17. The method of claim 16 in which the hardness of said elastomer is no more than durometer 30 Shore 00.

18. The method of claim 16 in which said pad has a thickness of no more than 0.5 cm.

19. The method of claim 15 in which said pad carries a strap member for adhering the pad to the skin.

20. The method of claim 15 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.

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

22. The method of claim 15 in which said pad is substantially free of compression.

23. The method of claim 15 in which said pad has a glass-smooth face in contact with the skin.

24. The method of claim 15 in which said pad has a thickness of greater than 0.5 cm.

25. The method of claim 15 in which said pad is substantially transparent.

28. The method of claim 15 in which said pad has a length and width each of at least 10 cm.

29. A flexible, 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.

30. The pad of claim 29 in which the hardness of the pad is no more than durometer 30 Shore 00.

31. The pad of claim 29 in which the pad is made of an elastomeric material which has an elongation to break of at least five hundred percent.

32. The pad of claim 29 in which the pad is packaged in sterile condition.

33. The pad of claim 29 which is substantially transparent.

34. The method which comprises:

wrapping the pad of claim 29 around an arm or leg of a patient, and overlapping retention straps carried by said pad along a portion of their lengths, whereby the pad is retained in position on the skin of the patient by natural tack adhesion between the retention straps.

35. The pad of claim 29 in which the pad comprises an elastomeric material.

36. 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 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.

37. The method of claim 36 is which the soft, elastomeric pad is affixed to the skin of the patient, and the pad is substantially transparent.

38. The method of claim 36 in which the pad is of a solid, domed shape.

39. The method of claim 38 in which said pad of solid, domed shape resides in a dome-shaped recess defined by a dome wall of a plastic sheet, said sheet also having a flat flange at least partially surrounding said dome wall, said flat flange being affixed to the skin of the patient, with the dome wall and the patient'"'"'s skin together enclosing the soft, elastomeric pad, and the pad abutting the skin.

40. The method of claim 39 in which said flat flange is affixed to the skin through an adhesive layer carried on the flange.

41. The method of claim 39 in which said plastic sheet is made of poly(ethylene-vinyl acetate).

42. The method of claim 39 in which said dome-shaped recess is cold formed in said plastic sheet.

43. The method of claim 39 in which the hardness of said elastomer is no more than about Durometer 30 Shore 00.

44. The method of claim 43 in which said elastomer has a tear resistance of at least about 800,000 dynes per cm.

45. The method of claim 44 in which the elongation to break of said elastomer is at least about 500 percent.

46. The method of claim 36 in which said pad has a glass-smooth face in contact with the skin.

47. The method of claim 36 in which said pad resides in a recess, defined by a recess wall of a plastic sheet, said sheet also having a flat flange at least partially surrounding said recess wall, said flat flange being affixed to the skin of the patient, with the recess wall and the patient'"'"'s skin together enclosing the soft, elastomeric pad, and the pad abutting the skin.

48. The method of claim 47 in which said flat flange is affixed to the skin through an adhesive layer carried on the flange.

49. The method of claim 47 in which said plastic sheet is made of poly(ethylene-vinyl acetate).

50. 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.

51. The pad and plastic sheet of claim 50 in which said pad and recess wall are of dome shape.

52. The pad and plastic sheet of claim 50 in which a peel-type closure is affixed to the flat flange to enclose the soft pad.

53. The pad and plastic sheet of claim 50 in which the flat flange carries skin adhesive.

54. The pad and plastic sheet of claim 50 in which the hardness of said elastomer is less than durometer 30 Shore 00.

55. The pad and plastic sheet of claim 54 in which said elastomer has a tear resistance of at least 800,000 dynes per cm.

56. The pad and plastic sheet of claim 54 in which the elongation to break of said elastomer is at least about 500 percent.

57. The pad and plastic sheet of claim 50 in which said flat flange is affixed to the skin of the patient through an adhesive layer.

58. The pad and plastic sheet of claim 50 in which said plastic sheet is made of poly (ethylene-vinyl acetate).

59. The pad and plastic sheet of claim 50 in which said pad defines a flat surface which is placed in contact with the skin, and is held in place by tape which adheres to the skin and passes over the dome-shaped recess wall.

60. The pad and plastic sheet of claim 50 in which said pad has a face that projects outwardly beyond said recess and plastic sheet.

61. The pad and plastic sheet of claim 54 which are packaged in sterile condition.

68. The soft pad of claim 50 in which said elastomeric pad includes a medicament.

69. The soft pad of claim 50 in which said pad is transparent.

62. A soft, hemostasis pad of elastomeric material having a hardness of no more than about durometer 50 Shore 00, said pad being of solid, dome shape with a flat bottom.

63. The soft, hemostasis pad of claim 62, said flat bottom resting on the skin of a patient, and a cover sheet extending over the dome-shaped pad and attached to the skin.

64. The soft, hemostasis pad of claim 62 in which the hardness is no more than about durometer 30 Shore 00.

65. The soft, hemostasis pad of claim 62, having an elongation to break of at least 500 percent.

66. The soft, hemostasis pad of claim 62 which includes a medicament.

67. The soft, hemostasis pad of claim 62 which is transparent.

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

whereby bleeding is substantially suppressed.

71. The pad of claim 70 in which the hardness of said pad is less than about durometer 30 Shore 00.

72. The pad of claim 70 which is transparent.

76. The pad of claim 70 which comprises a pair of opposed, parallel, equally sized major faces forming a flat sheet.

77. The pad of claim 70, which is elastomeric.

78. The pad of claim 70 which comprises an open or closed cell foam.

73. A soft pad, affixed to a needle pierceable wall of a medical fluid container, said pad consisting essentially of an elastomer having a hardness of no more than about durometer 50 Shore 00, whereby leakage is substantially suppressed.

74. The pad of claim 73 in which the hardness of said elastomer is no more than about durometer 30 Shore 00.

75. The pad of claim 73 which has a surface in contact with the wall of the medical fluid container, said surface being nonporous.