Fetal blood sampling instrument

• US 4,660,570 A
• Filed: 09/08/1986
• Issued: 04/28/1987
• Est. Priority Date: 06/28/1984
• Status: Expired due to Fees

• Current Assignee: Mitchell P. Dombrowski
• Original Assignee: Mitchell P. Dombrowski
• Inventors: Dombrowski, Mitchell P.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Hindenburg, Max F.
• Application Number:
  US06/906,561
• Time in Patent Office: 232 Days
• Field of Search: 128/763-770, 128/698, 604/14-16, 604/21, 604/51, 604/54, 604/55, 604/115, 604/133, 604/264, 604/272, 604/327, 604/330, 604/331, 604/403, 604/411
• US Class Current: 600/578
• CPC Class Codes: A61B 5/150015 Source of blood
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes

Abstract

An instrument (10) for obtaining a fetal blood sample including an elongated member (12) having an open end portion (14) and a membrane (16) disposed over the open end portion (14) for perfecting a seal about the open end portion (14). A lancet (18) in the form of a blade (64) or a sharp ended capillary tube (48) is disposed in the elongated member (12) for piercing the membrane (16) and making an incision in the skin of a fetus (20). A plunger (26) is supported within the elongated member (12) and is movable to create a suction within the open end portion (14) to draw fetal blood from the incision through the pierced membrane (16) and into the open end portion (14).

Claims

1. An instrument (10) for obtaining a fetal blood sample comprising:

an elongated member (12) having an open end portion (14), said open end portion (14) being hollow;

tissue thin membrane means (16) disposed in sheet-like fashion over said open end portion (14) for perfecting a seal about said open end portion (14) to close said open end portion (14) to outside contaminants;

lancing means (18) slidably supported within said elongated member (12) for piercing said membrane means (16) and making an incision in the skin (20); and

suction means for creating a suction within said open end portion (14) while maintaining the open end portion (14) and pierced membrane means (16) thereunder sealed against the skin and from outside contaminants to draw blood from the incision in the skin through said pierced membrane means (16) and into said hollow open end portion (14), gripping means (28,30,32) for holding the open end portion (14) and pierced membrane means (16) sealed against the skin while moving said lancing means (18) outward to pierce said membrane means (16) and adjacent skin and while withdrawing said lancing means (18) back out of the incision and said membrane means (16) and into said open end portion (14) and while actuating said suction means to draw blood into said open end portion (14).

2. An instrument as set forth in claim 1 wherein said elongated member (12) includes an inner chamber (22) having an inner wall (24) and including said open end portion (14), said instrument (10) including a plunger (26) slidably supported within said inner chamber (22), said suction means including sealing means mounted on said plunger (26) and slidably engaging said inner wall (24) to perfect a seal therewith whereby retraction of said plunger (26) moves said sealing means to create a suction within said open end portion (14) thereby drawing fetal blood through said pierced membrane means (16) and into said open end portion (14).

3. An instrument as set forth in claim 2 wherein said sealing means includes at least one annular gasket (34,38) disposed around a portion (36) of said plunger (26), said gasket (34,38) slidably engaging said inner wall (24) thereby perfecting a sliding seal therewith.

4. An instrument as set forth in claim 3 wherein said plunger (26) is slidably supported between an inserted position extending said lancing means (18) through said membrane means (16) and a retracted position wherein said lancing means (18) is disposed within said open end portion (14), said instrument (10) including biasing means (40) for biasing said plunger (26) to said retracted position.

5. An instrument as set forth in claim 4 wherein said plunger (26) is slidably mounted for movement to a third position beyond said retracted position to move said sealing means to create a suction within said open end portion (14) thereby drawing fluid through said pierced membrane means (16) and into said open end portion (14).

6. An instrument as set forth in claim 5 including motion limiting means for limiting the motion of said plunger (26) between said depressed and retracted positions.

7. An instrument as set forth in claim 6 wherein said motion limiting means including a guide tube (42) slidably housed within said elongated member (10) and a shoulder portion (44) extending into said inner chamber (22), said plunger (26) being housed within said guide tube (42) for movement therewith between said inserted position wherein said guide tube (42) engages said shoulder portion (44) and said retracted position wherein said guide tube (42) is axially spaced from said shoulder portion (44).

8. An instrument as set forth in claim 7 wherein said biasing means comprises a biasing member (40) disposed between said guide tube (42) and said shoulder portion (46) for biasing said guide tube (42) and said plunger (26) housed therein to said retracted position.

9. An instrument as set forth in claim 8 including a capillary tube (48) and capillary tube support means for slidably supporting said capillary tube (48) within said elongated member (10), said capillary tube (48) having a sharp end portion defining said lancing means (18), said capillary tube (48) being operatively connected to said plunger (26) and movable therewith between said depressed position wherein said sharp end portion extends through said membrane means (16) a predetermined distance and said retracted position wherein said sharp end portion is disposed within said open end portion (14) of said elongated member (12).

10. An instrument as set forth in claim 9 wherein said elongated member (12) includes a first sleeve (52) housing said guide tube (42) and said plunger (26), said elongated member (12) including a second sleeve (54) having one end detachably connected to said first sleeve (52) and a second end defining said open end portions (14) having said membrane means (16) disposed thereover, said capillary tube (48) being disposed within said second sleeve (54), said assembly 10 including potential volume limiting means within said second sleeve (54) for limiting the potential volume of said open end portion (14) whereby the blood sample is drawn into said capillary tube (48) rather than being consumed by the volume of said open end portion (14).

11. An instrument as set forth in claim 10 wherein said potential volume limiting means includes an O-shaped gasket (49) disposed about said capillary tube (48) and in sealing engagement with said inner wall of sleeve (54) thereby perfecting a seal therebetween.

12. An instrument as set forth in claim 9 wherein said capillary tube support means includes a constricted end portion (46) of said guide tube (42) for frictionally retaining said capillary tube (48) therein.

13. An instrument as set forth in claim 9 wherein said constricted end portion (46) of said guide tube (42) merges with the remainder of said guide tube (42) at a second shoulder portion (50), said plunger (26) being slidably movable within said guide tube (42) to said third position wherein said sealing means is axially spaced from said second shoulder portion (50) thereby creating a suction within said capillary tube (48) to draw fluid into said capillary tube (48).

14. An instrument as set forth in claim 2 including valve means having an open condition for allowing air to escape out of said open end portion (14) as said plunger (26) is moved from said retracted position to said depressed position prior to puncturing said membrane means (16) and said valve means having a closed condition preventing air flow into said open end portion (14) as said plunger (26) is moved to said retracted position thereby forming a suction within said open end portion (14) to draw fetal blood into said open end portion (14) through said pierced membrane means (16).

15. An instrument as set forth in claim 14 wherein said plunger (26) includes an end portion (70) and a piston (36), said sealing means being disposed about said piston (36) in slidably sealing engagement with said inner wall (24) of said inner chamber (22), said piston (36) having at least one opening (72) extending therethrough for air communication between said open end portion (14) and the remainder of said inner chamber (22), said valve means including a plug member mounted on the end portion (70) of said plunger (26) and a boot (76) mounted on said piston (36) over said openings (72) and having a boot opening (78), said plug member (74) being slidably retained within said boot opening (78) for engaging said boot (76) to sealingly close said boot opening (78) as said plunger (26) is retracted and for being spaced from said boot opening (78) as said plunger (26) is inserted.

16. An instrument as set forth in claim 14 wherein said inner wall (24) of said open end portion (14) includes at least one slot (80) extending therethrough, said valve means including a flexible gasket (82) disposed over said slot (80) whereby said gasket (82) allows one way outflow of air from said open end portion (14) through said slot (80) during movement of said plunger (26) to said depressed position while sealing off said slot (80) preventing inflow of fluid through said slot (80) as said plunger (26) is moved to said retracted position.

17. An instrument as set forth in claim 16 wherein said membrane means (16) includes a cup shaped elastic membrane including a thin tissue-like base portion (84) disposed over said open end portion (14) of said elongated member (12) and a thicker annular wall portion defining said gasket (82) and being disposed over said slot (80).

18. An instrument as set forth in claim 2 wherein said lancing means (18) including a lancet blade (64) mounted on the end of said plunger (26).

19. An instrument as set forth in claim 9 wherein said elongated member comprises a single sleeve (63).

20. An instrument as set forth in claim 19 wherein said sleeve (63) includes a cup shaped end portion (66) opposite said open end portion (14), said plunger (26) including bias abutment member (68) for engaging said biasing means (40), said biasing member (40) being mounted on said plunger (26) between said cup shaped end portion (66) and said abutment means (68).

21. A method for obtaining a blood sample comprising the steps of:

disposing a tissue thin membrane means (16) over the open hollow end portion (14) of a blood sampling instrument (10) to close the open end portion (14) to outside contaminants;

inserting the open end portion (14) to contact the presenting skin with the membrane means (16) pressed against the skin by the open end portion (14);

inserting a lancet (18) from within the open end portion (14) of the instrument (10) intradermally to make an incision in the membrane means (16) and the skin;

removing the lancet (18) from the incision and the membrane means (16) and into the instrument (10) while maintaining the pierced membrane means (16) and open end portion (14) sealed against the skin; and

creating a suction within the open end portion (14) of the instrument (10) to draw blood into the open end portion (14) from the incision in the skin and through the pierced membrane (16) by continuing said suction.

22. A method for obtaining a fetal blood sample as set forth in claim 21 including the steps of releasing the suction once the sample is drawn and removing the instrument (10).

23. A method for obtaining a fetal blood sample as set forth in claim 22 wherein a membrane (16) is disposed over the open end portion (14), said method further defined by contacting the membrane (16) to the presenting fetal skin, piercing the membrane (16) with the lancet (18) as the lancet (18) then cuts the fetal skin, and drawing the blood from the incision and through the membrane (16).

24. A method for obtaining a fetal blood sample as set forth in claim 23 wherein the step of releasing the suction is further defined by sealing off the open end portion (14) with the membrane (16) as the suction is released and withdrawing the sealed open end portion (14) from the incision.

25. A method for obtaining a fetal blood sample as set forth in claim 21 wherein the step of drawing blood is further defined as increasing the suction a predetermined amount to create a vacuum within the open end portion (14) to draw a predetermined amount of blood.

26. A method for obtaining a fetal blood sample as set forth in claim 21 wherein the instrument in inserted trans-vaginally to contact the presenting skin by palpation.

27. A method for obtaining a fetal blood sample as set forth in claim 21 further including the step of physically opening the incision in the skin by the suction slightly pulling the skin into an open end portion (14).