Injection and hemostasis site

• US 8,450,553 B2
• Filed: 09/01/2005
• Issued: 05/28/2013
• Est. Priority Date: 09/16/2004
• Status: Expired due to Fees

• Current Assignee: Lifestream Medical Corporation
• Original Assignee: DSU Medical Corporation
• Inventors: Utterberg, David S., Schnell, William J., Bell, David
• Primary Examiner(s): Lewis, Kim M
• Application Number:
  US11/218,220
• Publication Number:
  US 20060079823A1
• Time in Patent Office: 2,826 Days
• Field of Search: 604/304, 604/180, 604/174, 602/53, 602 41- 43, 602/58, 433/2, 433/8, 433/22, 606201-204, 606/213
• 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the skin or medical device wall, to make a resealable puncture with leakage reduction and hemostasis when the needle is withdrawn.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. A method of suppressing bleeding at a needle insertion site, comprising the steps of:

inserting a hollow cannula through a point in skin in a vessel 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 into the vessel; and

thereafter removing the cannula while simultaneously compressing the pad toward said point in the skin by a force insufficient to collapse the cannulated vessel, said pad having a hardness of no more than about durometer 50 Shore 00, whereby bleeding is immediately terminated and clotting is promoted by the pad.

2. The method of claim 1 is which the soft, elastomeric pad is affixed to the skin of the patient, and the pad is substantially transparent.

3. The method of claim 1 in which the pad is of a solid, domed shape.

4. The method of claim 3 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.

5. The method of claim 4 in which said flat flange is affixed to the skin through an adhesive layer carried on the flange.

6. The method of claim 4 in which said plastic sheet is made of poly(ethylene-vinyl acetate).

7. The method of claim 4 in which said dome-shaped recess is cold formed in said plastic sheet.

8. The method of claim 4 in which the hardness of said elastomer is no more than about Durometer 30 Shore 00.

9. The method of claim 8 in which said elastomer has a tear resistance of at least about 800,000 dynes per cm.

10. The method of claim 9 in which an elongation to break of said elastomer is at least about 500 percent.

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

12. The method of claim 1 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.

13. The method of claim 12 in which said flat flange is affixed to the skin through an adhesive layer carried on the flange.

14. The method of claim 12 in which said plastic sheet is made of poly(ethylene-vinyl acetate).

15. The method of claim 1 in which the soft, elastomeric pad is affixed against the skin by an adhesive member extending over the pad on the skin to press the pad against the skin.

16. The method of claim 15 in which the pad is substantially transparent.

17. A flexible, hemostasis pad having a flat non-porous surface immediately terminating bleeding upon application of said flat, non-porous surface to a bleeding vessel at a pressure insufficient to collapse said bleeding vessel, said pad having a rounded, convex outer surface, and a hardness of no more than about durometer 50 Shore 00, wherein a central portion of said pad is at least twice as thick as a peripheral portion of the pad at the edge of the pad.

18. A flexible, hemostasis pad having a non-porous surface immediately terminating bleeding upon application of said pad to a bleeding vessel at a pressure insufficient to collapse said bleeding vessel, said pad having a rounded, convex outer surface, and a hardness of no more than about durometer 50 Shore 00, the pad being substantially transparent, wherein a central portion of said pad is at least twice as thick as a peripheral portion of the pad at the edge of the pad.

19. The pad of claim 18 in which said non-porous surface is a flat surface.

20. A flexible, hemostasis pad having a non-porous surface immediately terminating bleeding upon application of said pad to a bleeding vessel at a pressure insufficient to collapse said bleeding vessel, said pad having a rounded, convex outer surface, and a hardness of no more than about durometer 50 Shore 00, wherein the pad comprises an elastomeric material, and said pad is substantially transparent and has a central portion which is substantially at least twice as thick as a peripheral portion of the pad at the edge of the pad.

21. The pad of claim 20 in which the non-porous surface is a flat surface.

22. A method of suppressing bleeding at a needle insertion site, comprising the steps of:

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

positioning a nonporous surface of a substantially transparent, soft pad against the skin of the patient to cover the point on the skin through which the cannula penetrates, and thereafter removing the cannula, while simultaneously during the removal process pressing said pad against said point and surrounding skin with a force insufficient to collapse the cannulated vessel, said pad being substantially transparent and having a hardness of no more than about durometer 50 Shore 00, whereby bleeding from said point is immediately terminated and clotting is promoted by the pad.

23. The method of claim 22 in which said pad has a rounded, convex outer surface.

24. The method of claim 22 in which a central portion of the pad is at least twice as thick as a peripheral portion of the pad at the edge.

25. The method of claim 24 in which the pad pressing against the skin at and surrounding the patient is accomplished by an adhesive bearing strap attached to the patient.

26. The method of claim 24 in which said pad pressing against the skin at and surrounding said point is accomplished manually.

27. The pad of claim 22 in which the non-porous surface is a flat surface.