Medical assay cassette

• US 5,744,095 A
• Filed: 11/14/1995
• Issued: 04/28/1998
• Est. Priority Date: 11/14/1995
• Status: Expired due to Fees

• Current Assignee: Smith, Henry J.
• Original Assignee: Smith, Henry J.
• Inventors: Smith, Henry J.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Swartz, Rodney P.
• Application Number:
  US08/557,336
• Time in Patent Office: 896 Days
• Field of Search: 128/743, 128/770, 128/771, 604/48, 604/49, 604/51, 604/93, 604/264, 604/272, 604/403, 606/167, 606/185, 422/50, 422/58, 422/79, 435/287.1, 435/805, 435/810, 436/46, 436/518
• US Class Current: 422/410
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/56988 HIV or HTLV
• CPC Class Codes: G01N 33/5761 Hepatitis B
• CPC Class Codes: Y10T 436/112499 with sample on test slide

Abstract

Over the counter assay cassette for clinical or home use for testing human conditions such as, HIV and Hepatitis B, having a blood well for receiving blood and viewing aperture for viewing an indication of the assay results and a membrane strip disposed within the cassette for receiving the blood and providing an indication of the human condition, is improved with an integrally disposed needle and an outer covering which, in a first position exposes the needle for drawing of the blood and exposes the blood well but covers the viewing aperture, and in a second position, covers the needle and exposes to the viewing aperture, so that, the human can view the results of the assay while the covered needle reduces the risk of secondary inadvertent puncturing by the used needle to reduce the risk of transmission of infectious disease.

Claims

1. A cassette for assaying a human condition comprising a casing defining a cavity within said cassette, a viewing aperture disposed in said casing and extending to said cavity for viewing an indication of said human condition of a human, a blood well disposed in said casing and extending to said cavity for receiving human blood to be assayed, an assay membrane disposed in said cavity for absorbing said human blood through the blood well and providing said indication, said human blood diffuses from said blood well through said assay membrane towards said viewing aperture, wherein improvement comprises,

a needle for puncturing said human to draw said human blood, said needle disposed in said cavity and extending outwardly through said casing of said cassette, said needle having a base end secured within said casing and having a needle end extending outwardly from said casing of said cassette for puncturing said human, and

a covering means mounted onto said cassette, said covering means having a first cover position for exposing said needle end while covering said viewing aperture and a second cover position for covering said needle end while exposing said viewing aperture.

2. The cassette of claim 1 wherein, said casing having a side and a face, said covering means is a sleeve having an covering aperture through which is disposed said cassette, said improvement further comprising,

a first stop means disposed on said face for positioning said sleeve in said first cover position for exposing said needle end at said side, for exposing said blood well on said face, and for covering said viewing aperture on said face, and

a second stop means disposed on said face for positioning said sleeve in said second cover position for covering said needle end at said side, for covering said blood well on said face, and for exposing said viewing aperture on said face.

3. The cassette of claim 1 wherein said improvement further comprises,

a needle aperture within said casing of said cassette for receiving a human finger of said human, said needle end extending into said needle aperture for puncturing said human finger to draw said human blood when said human finger is received and pressed into said needle aperture.

4. The cassette of claim 1 wherein said improvement further comprises,

a needle aperture within casing of said cassette for receiving a human finger of said human, said needle end extending into said needle aperture for puncturing said human finger to draw said human blood when said human finger is received and pressed into said needle aperture, and

a cap disposed within said needle aperture for covering said needle end prior to puncturing said human finger.

5. The cassette of claim 1 wherein said casing comprises a top and bottom fitted together to define said cavity, said improvement further comprises,

a needle base disposed within said cavity between said top and bottom of said casing, said needle integrally formed in said needle base at said base end, said needle extending from said needle base,

a needle stop disposed around said needle end and exposing a needle tip of said needle end, said needle stop buttressing said needle base, said needle stop defining a depth of puncture by said needle tip,

a needle aperture within said top and bottom of said casing of said cassette for receiving a human finger, said needle tip for puncturing at said depth said human finger to draw said human blood, and

a cap disposed within said needle aperture for covering said needle tip extending into said needle aperture for preventing puncturing of said human finger when said cassette is not in use.

6. The cassette of claim 1 wherein, said casing comprises a top and bottom fitted together to define said cavity, said improvement further comprises,

a needle base disposed within said cavity between said top and bottom of said casing, said cavity for positioning said needle base in a first needle position or a second needle position, said needle integrally formed in said needle base at said base end, said needle extending from said base end of said needle base, said needle end disposed within said cavity when said needle base is in said first needle position, said needle end exposed outside of said cavity for puncturing a first human finger to draw said human blood when said needle base is in said second needle position, and

a plunger aperture within said top and bottom of said casing of said cassette for receiving a second human finger and for exposing said base end of said needle base when said needle base is in said first needle position, said plunger aperture for receiving said second human finger for pressing against said base end of the needle base for moving said needle base from said first needle position to said second needle position for exposing said needle end.

7. The cassette of claim 6 wherein said casing has a side and a face, said covering means is a cover for covering said side and face of said cassette, said improvement further comprising,

a first stop means disposed on said face for positioning said cover in said first cover position for exposing said needle end extending outwardly from said side of said cassette, for exposing said blood well disposed on said face, and for covering said viewing aperture disposed on said face,

a second stop means disposed on said face for positioning said cover in said second cover position for covering said needle end, for covering said blood well, and for exposing said viewing aperture, and

a friction means disposed on said face and buttressing said cover, said friction means is disposed between said first and second stop means to resist movement of said cover from said first cover position to said second cover position.

8. The cassette of claim 1 wherein said casing comprises a top and bottom fitted together to define said cavity, said improvement further comprises,

a needle base disposed within said cavity between said top and bottom of said casing, said cavity for positioning said needle base in a first needle position or a second needle position, said needle integrally formed in said needle base at said base end, said needle extending from said base end of said needle base, said needle end disposed within said cavity when said needle base is in said first needle position, said needle end exposed outside of said cavity for puncturing a first human finger to draw said blood when said needle base is in said second needle position, and

a spring means disposed within said cavity and buttressing said needle base and said cavity of said casing for spring action between said cavity and said needle base for spring loading said needle base to said first needle position and for resisting movement of said needle base to said second needle position, and

a plunger aperture within said top and bottom of said casing of said cassette for receiving a second human finger and for exposing said base end of said needle base when said needle base is in said first needle position, said plunger aperture for receiving said second finger for pressing against said base end of said needle base for compressing said spring and moving said needle base from said first needle position to said second needle position.

9. The cassette of claim 8 wherein said improvement further comprises,

a needle aperture within said casing of said cassette for receiving a human finger of said human, said needle end extending into said needle aperture for puncturing said human finger to draw said human blood when said human finger is received and pressed into said needle aperture, and

a cap disposed within said needle aperture for covering said needle end prior to puncturing said first human finger.

10. The cassette of claim 8 wherein said improvement further comprises,

a needle stop disposed around said needle end and exposing a needle tip of said needle end, said needle stop buttressing said needle base, said needle stop defining a depth of puncture of said first human finger by said needle tip.