Injection and hemostasis site

• US 8,592,639 B2
• Filed: 09/14/2006
• Issued: 11/26/2013
• 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:
  US11/521,203
• Publication Number:
  US 20070066926A1
• Time in Patent Office: 2,630 Days
• Field of Search: 602/53, 602/41, 602/42, 602/43, 602/54, 602/52, 604/179, 604/180
• US Class Current: 602/53
• 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the skin or medical device wall, to make a resealable puncture with leakage reduction and hemostasis when the needle is withdrawn.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. An apparatus comprising:

a soft pad of elastomeric material having a hardness of no more than about durometer 50 Shore 00;

a strap member carried by the pad and adapted to apply the pad in direct contact with a site of bleeding or leakage,

whereby the bleeding or leakage is stopped by the pad with a pressure of approximately 25 grams.

2. The apparatus of claim 1 wherein the elastomeric material has an elongation to break of at least 500 percent.

3. The apparatus of claim 1 wherein the hardness of the elastomeric material is no more than about durometer 30 Shore 00.

4. The apparatus of claim 1, wherein the strap member is adhesive tape.

5. The apparatus of claim 1 wherein the elongation to break of the elastomeric material is about 900 percent to about 1000 percent.

6. The apparatus of claim 1 further comprising a smooth face adapted to contact the site.

7. An apparatus comprising:

an elastomeric hemostasis pad having a substantially nonporous surface adapted to prevent bleeding of a wound by being directly applied to the wound, and an upper surface with a raised profile;

a band extending over the upper surface of the pad to automatically apply a pressure to the wound, the band being selected from the group consisting essentially of an adhesive-backed tape or a strap;

wherein the pad is constructed of a material having a hardness of no more than about durometer 50 Shore 00.

8. The apparatus of claim 7 wherein the hardness of the pad is no more than about durometer 30 Shore 00.

9. The apparatus of claim 7 wherein the pad is constructed of an elastomeric material having an elongation to break of at least 500 percent.

10. The apparatus of claim 7 wherein the pad is packaged in a sterile condition.

11. The apparatus of claim 7 wherein the pad is substantially transparent.

12. A method comprising:

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

placing a soft, non-absorbent and elastomeric pad on the skin of the patient to apply pressure to the point of the skin; and

removing the cannula,

wherein the pad has a hardness of no more than about durometer 50 Shore 00, whereby bleeding is stopped by the pad under a pressure of about 25 grams.

13. The method of claim 12 wherein the pad is held against the skin of the patient with adhesive tape or a strap, and the pad is substantially transparent.

14. The method of claim 13 wherein the pad has an upper surface that is dome-shaped.

15. The method of claim 12 wherein the softness of the pad is about equal to the softness of human skin.

16. A soft, hemostasis pad comprising:

an upper wall with a raised profile; and

a flat bottom wall adapted to be applied to a wound of a patient for hemostasis,

wherein

the pad is constructed of an elastomeric material having a hardness of no more than about durometer 50 Shore 00, and

the pad is substantially clear.

17. The soft, hemostasis pad of claim 16, wherein the bottom is adapted to rest on skin of a patient, and wherein the pad is adapted to be covered by a cover sheet extending over the pad and adapted to be attached to the skin.

18. The soft, hemostasis pad of claim 16 wherein the hardness is no more than about durometer 30 Shore 00.

19. The soft, hemostasis pad of claim 17, wherein the pad is constructed of a material having an elongation to break of at least 500 percent.

20. The soft, hemostasis pad of claim 19 wherein the elastomeric material has a tear resistance of at least 800,000 dynes per cm.

21. The soft, hemostasis pad of claim 16 wherein the pad is transparent.