Blood aspiration assembly components and blunt needle aspirators

• US 5,531,672 A
• Filed: 01/11/1995
• Issued: 07/02/1996
• Est. Priority Date: 07/31/1987
• Status: Expired due to Term

• Current Assignee: Lawrence A. Lynn
• Original Assignee: Lawrence A. Lynn
• Inventors: Lynn, Lawrence A.
• Primary Examiner(s): Maglione, Corrine M.
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/371,127
• Time in Patent Office: 538 Days
• Field of Search: 604/4, 604/35, 604/36, 604/38, 604/83, 604/91, 604/122, 604/905, 604/27, 604/128, 604/257, 128/760, 128/762, 128/763, 128/765, 128/766
• US Class Current: 604/6.12
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61M 2005/3121 via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A blood aspiration assembly for use as a blood access device inserted in a patient'"'"'s blood vessel for obtaining undiluted blood samples. The assembly includes, in one embodiment, a first tubular portion defining a first internal volume. A distal end of the first segment is coupled to a blood access device and has a blood receiver at the proximal end thereof. The blood receiver permits a separate blood removal device to repetitively access its chamber. A second tubular portion or segment defining a third internal volume is coupled at its distal end to the blood receiver. A reservoir is coupled to the proximal end of the second segment so as to be in selective flow communication with it. The reservoir has a sufficient internal volume to selectively retrieve a volume X of fluid from the second segment, blood receiver, and first segment to insure that undiluted blood is present in the chamber of the blood aspirator. The third internal volume is sufficient such that when volume X is received by the reservoir the entire volume of mixed resident fluid and blood created by the flow of volume X into the reservoir is contained within the second segment.

Claims

1. An assembly for use with a blood access device inserted in a patient'"'"'s blood vessel for obtaining undiluted blood samples, the assembly comprising:

a sub-assembly including;

a first segment having distal and proximal ends and a flow path defined therethrough, defining a first internal volume which, in use, may be filled with a resident fluid, the first segment having means at said distal end thereof for coupling to a blood access device and having a blood receiver at said proximal end thereof and in flow communication therewith, said blood receiver having a chamber defined therein and a flow path defined therethrough together defining a second internal volume which, in use, may be filled with a resident fluid, the blood receiver having structure permitting a separate blood removal device to repetitively access the chamber; and

a second segment having distal and proximal ends and a flow path defined therethrough, defining a third internal volume which, in use, may be filled with a resident fluid, the second segment being operatively coupled at said distal end thereof to said blood receiver so as to be in flow communication therewith; and

a reservoir operatively coupled to the proximal end of said second segment so as to be in selective flow communication therewith, the reservoir having a sufficient internal volume to selectively receive a volume (X) of fluid from the sub-assembly sufficient to ensure that undiluted blood is selectively present in said chamber, said third internal volume being such that when said volume (X) is received by the reservoir an entire volume of mixed resident fluid and blood created by the flow of the volume (X) from the sub-assembly is contained within said second segment.

2. An assembly according to claim 1 further comprising a volume indicator for indicating when said volume (X) of fluid has entered said reservoir.

3. An assembly according to claim 1 wherein the internal volume of said second segment is fixed.

4. An assembly according to claim 1, further comprising structure for selectively varying the volume of said reservoir, and wherein the reservoir comprises a housing for containing fluid, the reservoir having means for reducing the pressure within said reservoir below the pressure within the blood vessel of the patient, and having means for increasing said reservoir pressure above said blood vessel pressure.

5. An assembly accordingly to claim 4, wherein the means for reducing reservoir pressure and means for increasing reservoir pressure comprises a piston movably mounted within the reservoir.

6. An assembly according to claim 1, wherein at least part of the second segment forms a capacitance segment which has an internal diameter greater than a diameter of the first segment.

7. An assembly according to claim 6, further comprising a third segment having distal and proximal ends and a flow path defined therethrough, the third segment being operatively coupled at said distal end thereof to said second segment so as to be in flow communication therewith, the third segment being operatively coupled at said proximal end thereof to a liquid source having a pressure greater than the pressure within the blood vessel of the patient, and wherein said third segment comprises a conduit which is in liquid flow connection with the capacitance segment, the conduit having a smaller internal diameter than the internal diameter of the capacitance segment.

8. An assembly according to claim 6, wherein the capacitance segment comprises a coil segment.

9. In combination with a blood access device inserted in a blood vessel of a patient and a separate blood removal device to remove blood from the patient, an assembly comprising:

(a) a reservoir having a target displacement volume;

(b) an aspirator receiver having a chamber and defining a blood flow path therethrough;

(c) a first conduit for connecting the blood access device to the aspirator receiver so that the first conduit is in liquid flow communication with said chamber;

(d) a second conduit connecting the aspirator receiver to the reservoir so that the second conduit is in selective flow communication with said chamber;

the second conduit, said chamber, the first conduit, and the blood access device being substantially filled with a fluid for maintaining patency thereof;

the second conduit having an internal volume which is greater than the target displacement volume of the reservoir;

the target displacement volume being sufficiently greater than an internal volume of said chamber plus an internal volume of said first conduit volume plus an internal volume of said blood access device such that displacement of a volume equal to said target displacement volume from the patient toward said reservoir presents substantially undiluted blood in said chamber, no blood in said reservoir, and substantially no blood in a segment of said second conduit immediately adjacent and distal to said reservoir;

(e) the aspirator receiver being selectively engageable with said blood removal device to allow the blood removal device to be in blood flow communication with said chamber so that a portion of the undiluted blood drawn into said chamber and the first conduit by the displacement of the volume equal to said target displacement volume can be withdrawn from said chamber and the first conduit into the blood removal device.

10. An assembly as in claim 9, wherein said target displacement volume is a total fluid receipt volume of said reservoir.

11. In combination with a blood access device that has an internal volume and is inserted into a blood vessel of a patient, a separate removal device to remove a blood sample from the patient, and an aspirator receiver having a chamber having an internal volume, an assembly comprising;

a first conduit having an internal volume operatively coupled to the blood access device and operatively coupled to the aspirator receiver so that the first conduit is in liquid flow communication with said chamber;

a second conduit having an internal volume, the second conduit, said chamber, the first conduit, and the blood access device being substantially filled with a resident fluid for maintaining patency thereof, prior to blood sampling; and

a reservoir for receiving by flow at least a specific displacement volume of fluid, said second conduit being operatively coupled to the aspirator receiver and operatively coupled to the reservoir so that the second conduit is in selective flow communication with said chamber, said displacement volume of said reservoir being sufficiently greater than the sum of the internal volumes of said chamber, the first conduit, and the blood access device, so that the displacement of said displacement volume of liquid into said reservoir causes a displacement volume of blood equal to said specific displacement volume to flow from the blood vessel of the patient toward the reservoir to displace by flow substantially all of the resident fluid within the blood access device, the first conduit, and the chamber to thereby present substantially undiluted blood in the chamber for sampling, at least a portion of said displacement volume of blood mixing with said resident fluid,

the second conduit having sufficient internal volume to receive by flow substantially all of the volume of blood which directly mixes with resident fluid in addition to substantially all of the volume of resident fluid which directly mixes with blood so that when the reservoir receives said displacement volume, the second conduit receives substantially all of the volume of blood and fluid add mixture, and undiluted blood is presented in the chamber without requiring blood to flow into the reservoir.

12. An assembly for use in combination with a catheter inserted into a blood vessel of a patient and a separate blood removal device to remove blood from the assembly, the assembly including a variable volume reservoir and further including a segment operatively coupled at one end thereof to and being in flow communication with the variable volume reservoir and including means at another end thereof for coupling a catheter inserted into a blood vessel of a patient, said segment having an internal volume, said segment further comprising a blood sampling port and a mixed fluid volume receiving section, the receiving section having an internal potential volume, said segment further being filled with resident fluid, said variable volume reservoir having an internal potential volume which is at least sufficient to receive by flow a displacement volume of resident liquid from said segment which allows an equal displacement volume of blood to enter said segment through the means for coupling, the displacement volume of blood being sufficient to displace substantially all resident fluid from said segment adjacent said port, a fraction of said volume of blood mixing with a fraction of the resident fluid when the blood enters the catheter and the assembly, the sum of the volume of blood fraction which directly mixes with resident fluid and the volume of resident fluid fraction which directly mixes with blood comprising a mixed fluid volume, said receiving section having sufficient internal potential volume to receive substantially all said mixed fluid volume so that when said displacement volume of resident fluid enters the reservoir and undiluted blood has filled the assembly adjacent the sampling port, blood does not enter the reservoir.

13. The assembly of claim 12 wherein said receiving section has a fixed internal potential volume.

14. An assembly for use with a blood access device inserted in a patient'"'"'s blood vessel for obtaining undiluted blood samples characterized in that:

the assembly comprises a tubular portion, having a potential internal fluid volume, said tubular portion being adapted to be filled with a liquid and being operatively coupled to and in selective fluid communication at one end thereof with a said blood access device and at another end with at least a variable volume reservoir, said tubular portion further including a blood receiver having a chamber and having structure permitting a separate blood removal device to repetitively access said chamber, said variable volume reservoir having sufficient internal volume to selectively receive at least a first volume of fluid from said tubular portion, said first volume being sufficient to ensure that undiluted blood is drawn into and substantially fills said chamber, said potential internal volume of said tubular portion being sufficiently greater than said first volume so that no blood is drawn into said variable volume reservoir when said reservoir receives said first volume.

15. An assembly as in claim 14 further comprising a volume indicator for indicating when said volume of blood equal to said first volume has entered said tubular portion.

16. An assembly as in claim 14, wherein the potential internal volume of said tubular portion is fixed.

17. An assembly as in claim 14, wherein the internal volume of said tubular portion is filled with a resident fluid and includes a mixed fluid volume storage section positioned intermediate said chamber and said reservoir, said mixed fluid volume storage section having an internal volume sufficient to receive substantially all of a fraction of blood and a fraction of resident fluid that intermix upon the flow of said first volume into said reservoir.

18. An assembly as in claim 17, wherein, upon the flow of said first volume into said reservoir, a volume of blood substantially equal to said first volume enters said tubular portion, said volume of blood being sufficient to displace substantially all resident fluid from said chamber.

19. An assembly for use with a blood access device inserted in a patient'"'"'s blood vessel for obtaining undiluted blood samples, the assembly comprising:

a sub-assembly including;

a first segment having distal and proximal ends and a flow path defined therethrough, defining a first internal volume which, in use, may be filled with a resident fluid, the first segment having means at said distal end thereof for coupling to a blood access device and having a blood receiver at said proximal end thereof and in flow communication therewith, said blood receiver having a chamber defined therein and a flow path defined therethrough, together defining a second internal volume which, in use, may be filled with a resident fluid, the blood receiver having structure permitting a separate blood removal device to repetitively access the chamber; and

a second segment having a flow path defined therethrough, selectively defining a third internal volume, the second segment being operatively coupled at one end thereof to said blood receiver so as to be in flow communication therewith; and

a reservoir operatively coupled to an end of said second segment opposite said one end so as to be in selective flow communication therewith, the reservoir selectively having a sufficient internal volume to selectively receive a volume (X) of fluid from the sub-assembly, said volume (X) being a maximum volume of said reservoir, said volume (X) and said third volume being sufficient to ensure that undiluted blood is selectively present in said chamber, said third internal volume being such that when said volume (X) is received by the reservoir and said third volume is received by said second segment, an entire volume of mixed resident fluid and blood created by the flow of the volume (X) from the sub-assembly is contained within said second segment.