Disposable skin perforator and blood testing device

• US 5,054,499 A
• Filed: 08/10/1990
• Issued: 10/08/1991
• Est. Priority Date: 03/27/1989
• Status: Expired due to Fees

• Current Assignee: Remi D. Swierczek
• Original Assignee: Remi D. Swierczek
• Inventors: Swierczek, Remi D.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/566,160
• Time in Patent Office: 424 Days
• Field of Search: 128/770, 128/762, 128/767, 128/637, 128/743, 604/22, 606/167, 606/222, 606/223, 606/224, 606/227, 606/182, 606/185, 206/367, 206/365, 206/339, 206/571
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A device that pierces the skin due to the collapsing of dome between the fingertips. Immediately after a puncture is made, a blood or exudate sample can be collected on an absorbent test strip laminated on the pressure plate. Flow enhancement of blood or exudate from the puncture site is achieved by maintenance of pressure around the site and on the imparting of a vacuum within the device.

Claims

1. A skin perforator for obtaining a sample of blood by puncturing the skin comprising:

(a) a pressure plate containing an aperture formed therein wherein said pressure plate is placed adjacent to the area of skin to be punctured;

(b) a cover plate having a resilient convex panel formed therein, said cover plate being attached to said pressure plate and said convex panel having a point penetrating barb formed integrally therefrom and directed inward toward said aperture in said pressure plate wherein a pressure applied to the convex panel and directed toward said pressure plate overcomes the resistance of said convex panel and said convex panel undergoes at least a partial inversion to cause said barb to suddenly and rapidly penetrate the skin causing a puncture, said convex panel having a memory so as to resiliently return to its original convex shape upon removal of said pressure thereby withdrawing the barb from the skin.

2. The skin perforator as recited in claim 1 wherein said perforator further comprises a means for effecting at least a partial vacuum around said puncture during withdrawal of the barb from the skin.

3. The skin perforator as recited in claim 2 wherein said perforator further comprises a sealing means around at least a substantial portion of a periphery of said pressure plate and said cover plate.

4. The skin perforator as recited in claim 2 wherein said perforator further comprises at least one step formed along a periphery between said pressure plate and said cover plate.

5. The disposable skin perforator as recited in claim 4 wherein at least one step formed along a periphery between said pressure plate and said cover plate extends inwardly to a region such that said step contacts said convex panel upon said convex panel'"'"'s collapse.

6. The skin perforator as recited in claim 1 wherein said perforator further comprises a means for controlling the penetration depth of said skin by said barb.

7. The skin perforator as recited in claim 6 wherein said penetration controlling means comprises a shelf formed around said aperture in said pressure plate.

8. The skin perforator as recited in claim 1 wherein said perforator further comprises an absorbent test strip attached to said pressure plate to absorb blood or exudate flowing from a puncture site formed by the penetration of said barb.

9. The skin perforator as recited in claim 8 wherein said test strip is treated with at least one reagent for medical analysis.

10. The skin perforator as recited in claim 8 wherein said test strip further comprises an aperture therein and positioned to allow passage of at least a portion of said barb.

11. A skin perforator for obtaining and collecting a sample of blood by puncturing the skin comprising:

a pressure plate containing an aperture wherein said pressure plate is placed adjacent to the area of skin to be punctured;

an absorbent test strip attached to said pressure plate to absorb blood or exudate flowing from a puncture site formed by the penetration of a barb;

a cover plate having a resilient convex panel formed therein, said cover plate being attached to said pressure plate and said convex panel having a point penetrating barb formed integrally therefrom and directed inward toward said aperture in said pressure plate wherein a pressure applied to the convex panel and directed toward said pressure plate overcomes the resistance of said convex panel and said convex panel undergoes at least a partial inversion to cause said barb to suddenly and rapidly penetrate the skin causing a puncture, said convex panel having a memory so as to resistantly return to its original convex shape upon removal of said pressure thereby withdrawing the barb from the skin.

12. The skin perforator as recited in claim 11 wherein said perforator further comprises a means for effecting at least a partial vacuum during withdraw of the barb from the skin.

13. The skin perforator as recited in claim 12 wherein said perforator further comprises a sealing means around at least a periphery between said pressure plate and said cover plate.

14. The skin perforator as recited in claim 12 wherein said perforator further comprises at least one strip formed along a periphery between said pressure plate and said cover plate.

15. The skin perforator as recited in claim 14 wherein at least one step formed along a periphery between said pressure plate and said cover plate extends inwardly to a region such that said step contacts said convex panel upon said convex panels collapse.

16. A skin perforator as recited in claim 11 wherein said perforator further comprises a means for controlling the penetration depth of said skin by said barb.

17. The skin perforator as recited in claim 16 wherein said penetration controlling means comprises a shelf formed around said aperture in said pressure plate.

18. The skin perforator as recited in claim 11 wherein said strip is treated with at least on reagent for medical analysis.

19. The skin perforator as recited in claim 11 wherein said test strip further comprises an aperture formed therein and positioned to allow passage of a least a portion of said barb.

20. The skin perforator as recited in claim 11 wherein said aperture is sized to enhance blood blow from the puncture when slight pressure is maintained upon said pressure plate.

21. A method for puncturing the skin and collecting a blood sample comprising:

(a) isolating an area of skin to be punctured;

(b) placing a skin perforator device adjacent to the area to be punctured, said skin perforator device comprising a pressure plate containing an aperture surrounding the area of skin to be punctured, an absorbent test strip attached to said pressure plate to absorb blood or exudate flowing from a puncture site formed by the penetration of a barb, a cover plate having resilient convex panel formed therein, said cover plate being attached to said pressure plate and said convex panel having a point penetrating barb formed integrally therefrom and directed inward toward said aperture in said pressure plate;

(c) applying a pressure to overcome the resistance of said convex panel and to cause at least a partial inversion of said convex panel and a rapid and sudden penetration of the skin by said barb;

(d) reducing said pressure such that said convex panel resiliently returns to its original convex shape thereby withdrawing the barb from said skin;

(e) maintaining a pressure upon said skin perforator to enhance blood flow from the puncture and obtain essentially immediate collection of blood or exudate by said test strip.

22. The method according to claim 21, comprising a further step, inserted following step c:

effecting at least a partial vacuum to the area immediately adjacent to the puncture site to enhance blood flow from the puncture site.