Blood aspiration assembly and method

• US 4,838,855 A
• Filed: 07/31/1987
• Issued: 06/13/1989
• 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): Rosenbaum, C. Fred
• Assistant Examiner(s): Costantino, Mario
• Application Number:
  US07/080,406
• Time in Patent Office: 683 Days
• Field of Search: 128/760, 128/762, 128/764-766, 128/768, 128/771, 604/4, 604/8, 604/9, 604/48-50, 604/80-86, 604/118, 604/121, 604/124, 604/125, 604/131-135, 604/93, 604/181, 604/183, 604/184, 604/186, 604/187, 604/201, 604/205 , 604/208, 604/236, 604/240, 604/244, 604/246, 604/248, 604/256, 604/280, 604/283, 604/284, 604/218, 604/220, 604/221, 604/222, 604/228, 604/27-29, 604/32, 604/35, 604/38
• US Class Current: 604/540
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• 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: A61M 2005/31506 formed as a single piece, e.g. moulded
• CPC Class Codes: A61M 2005/31508 provided on the piston-rod
• CPC Class Codes: A61M 39/02 Access sites

Abstract

A blood aspiration assembly and method has proximal, intermediate and distal tubing, a reservoir having an adjustable volume and an aspirator receiver. A two-way valve can connect the reservoir to the intermediate tube and block flow to the proximal tubing, or can connect the intermediate and proximal tubing while blocking flow to the reservoir. The reservoir can be locked into selected withdrawal and discharge positions. The intermediate tube is connected with the aspirator receiver. The receiver is connected with the distal tubing. The receiver has a housing comprising a rigid casing and a resilient plug. The valve and reservoir can be operated to withdraw resident fluid from the assembly flow channels distal thereto into the reservoir, and draw blood from the patient into the intermediate tube to remove resident fluid from the aspiration chamber. A needle from a separate syringe is inserted through the plug into the aspirator chamber and a blood sample withdrawn. The reservoir has a predetermined potential maximum fluid volume equal to that volume which, when withdrawn into the reservoir from the intermediate tube, results in the replacement of essentially all resident fluid in the aspiration chamber and that portion of the apparatus distal to the aspiration chamber by essentially undiluted blood. The reservoir volume is less than the total internal volume of the apparatus distal to the reservoir whereby withdrawal of fluid into the reservoir does not cause blood to flow into the reservoir. The intermediate tube can have an enlarged section of be spiralled.

Claims

1. A blood aspiration assembly for use with a blood removal means inserted in a blood vessel of a patient and a separate aspirating means to remove blood from a patient, comprising:

(a) means for providing a reservoir having a maximum displacement volume;

(b) an aspirator receiver means having a chamber for permitting blood flow therein;

(c) means for providing a first conduit for connecting the blood removal means to the aspirator receiver means so that the first conduit means is in liquid flow connection with the receiver chamber;

(d) means for providing a second conduit connecting the aspirator receiver to the reservoir means so that the second conduit means can be in liquid flow connection with the receiver chamber;

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

(e) the aspirator receiver having a portion for receiving a part of the aspirating means to allow the aspirating means to be in blood flow connection with the aspirator receiver chamber so that blood drawn into the receiver chamber and into the first conduit means can be withdrawn from the aspirator receiver chamber and the first conduit means into the aspirating means.

2. The blood aspiration assembly of claim 1 further comprising means for making a volume of blood equal to the maximum displacement volume of the reservoir to flow from the blood vessel into the blood removal means, into the first conduit means, into the aspiration receiver chamber, and into a portion of the second conduit means, the second conduit means providing a capacitance function so that blood does not flow into the reservoir means.

3. The blood aspiration assembly of claim 1, further comprising the said receiver portion having means for sealing itself to block blood flow therethrough when the aspirating means is removed from the aspirator receiver.

4. The blood aspiration assembly of claim 1 further comprising means for inhibiting liquid flow through the second conduit so that when the aspirating means aspirates liquid from the receiver chamber, substantial liquid located within the second conduit does not flow into the aspiration receiver chamber.

5. The blood aspiration assembly of claim 4 wherein said means for inhibiting liquid flow through said second conduit comprises a liquid flow blocking means located between the reservoir and said aspirator receiver chamber.

6. The blood aspiration assembly of claim 5 wherein said means for inhibiting flow comprises a clamp located on the second conduit.

7. The blood aspiration assembly of claim 3 wherein the receiving portion of the receiver means comprises a resilient material.

8. The blood aspiration assembly of claim 7 wherein the resilient material comprises silicone.

9. The blood aspiration assembly of claim 7 wherein the receiver comprises a rigid section to which the receiving portion is associated, the rigid section extending to a side of the chamber opposite the resilient portion, the rigid section having a hardness and being sized to resist puncture by the aspirating means when normal forces are applied to the aspirating means against the rigid portion.

10. The blood aspiration assembly of claim 2 wherein the means for making blood flow includes the reservoir comprising a housing for containing liquid, the housing being in liquid flow connection with the second conduit means, means for creating suction in the housing to draw liquid from the second conduit into the reservoir housing, and to cause liquid flow from the blood removal means, the first conduit means and the receiver chamber toward the reservoir housing.

11. The blood aspiration assembly of claim 10 wherein the means for creating suction comprises the reservoir housing having a piston movably mounted therein so that piston movement in a selected direction creates suction to draw liquid from the second conduit into the reservoir housing.

12. The blood aspiration assembly of claim 11 further comprising the piston having a stroke for discharging liquid from the housing and for withdrawing liquid into the housing, and where means for inhibiting liquid flow through the second conduit comprises means for locking the piston in fixed position relative to the housing when the piston is in a fully withdrawn position.

13. The blood aspiration assembly of claim 12 further comprising means for locking the piston in fixed position relative to the housing when the piston is in a fully discharged position.

14. The blood aspiration assembly of claim 1 further comprising means for blocking liquid flow from the second conduit means to the reservoir.

15. The blood aspiration assembly of claim 14 wherein the means for blocking flow between the second conduit and the reservoir is a valve.

16. The blood aspiration assembly of claim 1 further comprising means for providing a third conduit, the third conduit having means for liquid flow connection to the second conduit.

17. The blood aspiration assembly of claim 16 wherein the means for liquid flow connection comprises a valve having a first position and a second position, which in the first position permits liquid flow from the third conduit means to the second conduit means and blocks liquid flow from the first and second conduit means to the reservoir, and in the second position blocks liquid flow from the third conduit means to the second conduit means but permits liquid flow from the second conduit to the reservoir.

18. The blood aspiration assembly of claim 9 wherein the receiver comprises a tubular portion, a rigid extension projecting generally radially from the tubular portion, the extension having means for mounting the resilient portion.

19. The blood aspiration assembly of claim 18 wherein the means for mounting comprises the extension having a bore to receive the resilient portion.

20. The blood aspiration assembly of claim 19 wherein the resilient portion is a plug shaped to fit within the bore of the extension.

21. The blood aspiration assembly of claim 19 wherein the resilient portion is a plug having a generally frustum shape, and the extension bore generally is frustum shaped.

22. The blood aspiration assembly of claim 9 wherein the receiver chamber is formed by the rigid section of the receiver means and by the resilient material portion of the receiver means, an interface between the rigid section and resilient material portion, the said interface being smooth so as to provide smooth flow of liquid in the chamber as liquid flows past the interface of the resilient material portion with the rigid section.

24. The blood aspiration assembly of claim 22 wherein the chamber is of cylindrical shape.

23. The blood aspiration assembly of claim 23 wherein in the preamble the blood removal means comprises a needle;

and the body of the claim further comprising a cap, means for securing the cap to the extension, the cap having a hole for alignment with the resilient portion so that a needle can pass through the cap hole through the resilient portion and into the chamber.

25. A blood aspiration assembly for use with an insertion catheter to be inserted in a blood vessel of a patient and a separate aspirating means with a needle having a bore to remove blood from a patient, comprising:

(a) means for providing a reservoir, the reservoir having means to vary the internal volume of the reservoir and a maximum displacement volume;

(b) means for receiving the separate aspirating needle, the said receiving means having a chamber for permitting blood flow therethrough, the receiving means comprising a housing which includes a rigid casing and a resilient portion associated with the casing, the resilient portion being positioned with the casing so that the separate aspiration needle can penetrate the resilient portion to enter the chamber to be in liquid flow communication therewith;

(c) means for providing a first conduit for connecting the catheter to the receiving means so that the first conduit means is in liquid flow connection with the receiver chamber;

(d) means for providing a second conduit for passing liquid in either direction, the second conduit means connecting the receiver to the reservoir means so that the second conduit means can be placed in liquid flow connection with the receiving means chamber, the second conduit means having an internal volume which is greater than the maximum displacement volume of the reservoir;

(e) means for providing a third conduit;

(f) a valve connected between the reservoir and the second conduit means, the valve having means for being placed in a first position so that the reservoir means is in liquid flow connection with the second conduit, and the valve having means to be placed in a second position to place the third conduit means in liquid flow connection with the second conduit means;

(g) the reservoir having means for creating a pressure differential to cause liquid to flow from the second conduit into the reservoir means when the valve connects the reservoir means to the second conduit for liquid flow therebetween; and

(h) means for inhibiting liquid flow in the second conduit means so that when said means inhibits flow in the second conduit and when blood is aspirated from the receiver chamber through the needle into the separate aspirating means, additional blood flowing into the receiver chamber and into the first conduit comes from the patient and substantial blood does not flow from the second conduit into the aspirating means.

26. The blood aspiration assembly of claim 25 wherein the means for varying the volume of the reservoir means has a fully discharged and fully withdrawn position, and further comprising means for locking the means for varying the volume of the reservoir in the fully withdrawn position.

27. A method of aspirating blood from a human through the use of blood removal means connected to a first conduit, the first conduit being connected to an aspirator receiver having a chamber, the said chamber connected to a second conduit, the second conduit connected to a reservoir, the reservoir having a maximum displacement volume, the first conduit, the aspirator receiver chamber, and the second conduit being filled with intravenous fluid;

and through use of a separate aspirating means having a needle, comprising the steps of;

(a) causing a volume of intravenous fluid to flow through the second conduit into the reservoir which volume of fluid is less than the internal flow volume of the second conduit and which volume is equal to the maximum displacement volume of the reservoir, the said flow of intravenous fluid causing a volume of blood equal to the maximum displacement volume of the reservoir to enter the first conduit, the receiver chamber and a portion of the second conduit so that blood does not flow into the reservoir;

(b) inhibiting flow of fluid toward the receiver chamber from the second conduit;

(c) inserting the needle from the separate aspirating means into the receiver chamber and aspirating blood therefrom and withdrawing the needle from the receiver; and

(d) substantially sealing the aspirator receiver about the entry point of the separate aspirating needle.

29. An assembly for use with a blood removal means inserted in a blood vessel of a patient, for repetitive isolation of a volume of blood for testing or sampling, comprising:

(a) means for providing an enclosed flow channel capable of being filled with liquid, the said flow channel having means for being in liquid flow connection with the blood removal means, and means for being in liquid flow connection with a liquid source having a pressure greater than the pressure within the said blood vessel;

(b) the channel having a blood analysis section;

(c) means for providing a reservoir, the reservoir means having a maximum displacement volume, the reservoir means further having means for withdrawing a volume of blood equal to said maximum displacement volume from the blood vessel into said channel;

(d) means for retaining all of said displacement volume of blood entering the assembly within the flow channel when the withdrawing means withdraws a volume of blood equal to the maximum displacement volume of the reservoir means;

(e) means for returning essentially all the said displacement volume of the blood in the flow channel back through the blood removal means into the patient'"'"'s said blood vessel, the returning blood being moved in a direction within the said flow channel that is opposite the direction of blood entry into the flow channel.

28. The method of claim 29 further comprising the step of discharging intravenous fluid from the reservoir into the second conduit so that intravenous fluid forces blood within the aspirator receiver chamber, the first conduit and the blood removal means back into the vessel of the patient.

30. The assembly of claim 29 wherein the reservoir has a variable volume, and the reservoir comprises a housing for containing liquid and having means for liquid connection to the analysis section of said channel, the reservoir having means for reducing the pressure within said reservoir below the pressure within the blood vessel, and having means for increasing said reservoir pressure above said blood vessel pressure.

31. The assembly of claim 30 wherein the means for retaining all of said displacement volume of blood comprises means for providing a flow channel capacitance segment, the said segment being intermediate the reservoir and the analysis section and wherein intravenous liquid can initially be received within the capacitance segment channel, the said segment having an internal volume which is greater than the maximum displacement volume of the reservoir.

32. The assembly of claim 31 further comprising means for blocking liquid flow between the reservoir and the higher pressure source.

33. The assembly of claim 32 wherein the means to block flow comprises a valve, the valve having means for alternately allowing liquid flow connection between the reservoir and the blood removal means while blocking flow from the higher pressure source, or between the higher pressure source and the blood removal means while blocking flow from the reservoir.

34. The assembly of claim 30 wherein the means for reducing reservoir pressure and means for increasing reservoir pressure comprises a piston movably mounted within the reservoir.

35. The assembly of claim 34 further comprising means for locking the piston relative to the housing in a fully withdrawn position to maintain a fixed internal liquid volume within the reservoir.

36. The assembly of claim 35 wherein the means for locking the piston comprises a rod having a longitudinal axis, the rod and the reservoir housing having means for interlocking to hold the piston in a fully withdrawn position.

37. The assembly of claim 36 wherein the means for locking comprises the reservoir housing having an opening to allow sliding movement of the longitudinal axis of the rod therethrough, and wherein the rod has a variance in its transverse width along part of its longitudinal axis so that when the rod is moved to a selected position relative to the housing opening, a portion of the rod having the variance can be moved to engage the reservoir housing to lock the rod to the housing.

38. The assembly of claim 36 further comprising a flexible sleeve connected to the reservoir housing and connected to the rod to provide a seal about the housing opening.

39. The assembly of claim 31 wherein at least part of the enclosed flow channel is intermediate the analysis section and the blood removal means, and wherein the capacitance segment has an internal diameter greater than the diameter of the said part of the flow channel between the blood removal means and the analysis section.

40. The assembly of claim 39 wherein the means for being in flow connection with the higher pressure source comprises a conduit which is in liquid flow connection with the capacitance segment, the said conduit having a smaller internal diameter than the internal diameter of the capacitance segment.

41. The assembly of claim 40 wherein the capacitance segment is connected to the conduit by a channel segment having a tapered portion of a general frustum shape.

42. The assembly of claim 31 wherein the capacitance segment comprises a coil segment.

43. The assembly of claim 32 further comprising means for permanently preventing liquid flow connection between the higher pressure source and the reservoir, said means having means for providing liquid flow connection between the high pressure source and the blood analysis section while preventing connection between the high pressure source and the reservoir.

44. The assembly of claim 29 wherein the blood analysis section has means to receive a means for blood aspiration for blood sampling.

45. An assembly for use with a blood removal means inserted in a blood vessel of a patient, for repetitive isolation of a volume of blood for testing or sampling, comprising:

(a) means for providing an enclosed flow channel capable of being filled with liquid and for passing liquid in either direction, the said flow channel having means for being in liquid flow connection with the blood removal means, and means for being in liquid flow connection with a liquid source having a pressure greater than the pressure within the said blood vessel;

(b) the channel having a blood analysis section, the said section having means for receiving a means for aspiration of blood for sampling;

(c) means for providing a reservoir, the reservoir means having a maximum displacement volume, the reservoir means further having means for withdrawing a volume of blood equal to said maximum displacement volume from the blood vessel into said channel;

(d) means for providing a flow channel capacitance segment, the said segment being intermediate the reservoir and the analysis segment, wherein intravenous liquid can initially be received within the capacitance segment channel, the said segment having an internal volume which is greater than the maximum displacement volume of the reservoir;

(e) means for returning essentially all the said displacement volume of the blood in the flow channel back through the blood removal means into the patient'"'"'s said blood vessel, the returning blood being moved in a direction within the said flow channel that is opposite the direction of blood entry into the flow channel.

46. In a blood aspiration assembly having a blood removal means with a set internal flow volume, the blood removal means being for insertion in a blood vessel of a patient, and a separate aspirating means for removing blood from a patient,

(a) means for providing a reservoir having a displacement volume and means for indicating when a specific displacement volume has entered the reservoir;

(b) means for providing an aspirator receiver having a chamber for permitting blood flow therein;

(c) means for providing a first conduit for connecting the blood removal means to the aspirator receiver means so that the first conduit means is in liquid flow connection with the receiver chamber;

(d) means for providing a second conduit for passing liquid in either direction, the second conduit means connecting the aspirator receiver means to the reservoir means so that the second conduit means can be in liquid flow connection with the receiver chamber;

(e) the aspirator receiver means having a portion for receiving a part of the aspirating means to allow the aspirating means to be in blood flow connection with the aspirator receiver chamber so that blood drawn into the receiver chamber and into the first conduit means can be withdrawn from the aspirator receiver chamber and the first conduit means into the aspirating means;

(f) means for making a predesignated volume of blood to flow from the blood vessel into the blood removal means, into the first conduit means, and into the aspiration receiver chamber, and into a portion of the second conduit means;

the second conduit means providing a capacitance function so that blood does not flow into the reservoir means;

the predesignated volume of blood being equal to the said specific displacement volume of the reservoir and which is equal at least to the internal flow volume of the blood removal means, the first conduit means and the aspirator receiver chamber; and

(g) the predesignated volume of blood being less than the internal flow volume of the blood removal means, the first conduit means, the aspirator receiver chamber, and second conduit means.

47. The blood aspiration assembly of claim 46 wherein when the blood removal means, the first conduit means, the receiver chamber and the second conduit means initially have their internal flow volumes filled substantially with resident intravenous liquid, the means for making a predesignated volume of blood flow further making a sufficient amount of blood flow through the device to substantially replace the resident liquid in the blood removal means, the first conduit means and the receiver chamber with substantially undiluted blood.

48. The blood aspiration assembly of claim 47 further comprising means for inhibiting liquid flow through the second conduit so that when the aspirating means aspirates liquid from the receiver chamber, substantial liquid located within the second conduit does not flow into the aspiration receiver chamber.

49. The blood aspiration assembly of claim 48 wherein said means for inhibiting liquid flow through said second conduit comprises a liquid flow blocking means located between the reservoir and said aspirator receiver chamber.

50. The blood aspiration assembly of claim 49 wherein said means for inhibiting flow comprises a clamp located on the second conduit between said aspirator receiver means and said reservoir.

51. The blood aspiration assembly of claim 50 wherein the receiving portion of the receiver means comprises a resilient material.

52. The blood aspiration assembly of claim 51 wherein the blood aspiration means is a stainless steel needle, and wherein the receiver means comprises a rigid section to which the receiving portion is associated, the rigid section extending to a side of the chamber opposite the resilient portion, the rigid section having a hardness and being sized to resist puncture by the steel needle when normal forces are applied to the aspirating means against the rigid portion.

53. The blood aspiration assembly of claim 46 wherein the means for making blood flow includes the reservoir comprising a housing for containing liquid, the housing being in liquid flow connection with the second conduit means, means for creating suction in the housing to draw liquid from the second conduit into the reservoir housing, and to cause liquid flow from the blood removal means, the first conduit means and the receiver chamber toward the reservoir housing.

54. The blood aspiration assembly of claim 53 wherein the means for creating suction comprises the reservoir housing having a piston movably mounted therein so that piston movement in a selected direction creates suction to draw liquid from the second conduit into the reservoir housing.

55. The blood aspiration assembly of claim 54 further comprising the piston having a stroke for discharging liquid from the housing and for withdrawing liquid into the housing, and where the means for inhibiting liquid flow through the second conduit comprises means for locking the piston in fixed position relative to the housing when the piston is in a fully withdrawn position.

56. The blood aspiration assembly of claim 55 further comprising means for locking the piston in fixed position relative to the housing when the piston is in a fully discharged position.

57. The blood aspiration assembly of claim 46 further comprising means for blocking liquid flow from the second conduit means to the reservoir.

58. The blood aspiration assembly of claim 46 further comprising means for providing a third conduit, the third conduit having means for liquid flow connection to the second conduit, and wherein the means for liquid flow connection comprises a valve having a first position and a second position, which in the first position permits liquid flow from the third conduit means to the second conduit means and blocks liquid flow from the first and second conduit means to the reservoir, and in the second position blocks liquid flow from the third conduit means to the second conduit means but permits liquid flow from the second conduit to the reservoir.

59. The blood aspiration asseembly of claim 46 wherein the resilient portion comprises a plug shaped to fit with the aspirator receiver means, and wherein the receiver chamber is formed by the rigid part of the receiver means and by the resilient portion and wherein the inner face between the rigid part and the resilient portion is smooth so as to provide smooth flow of liquid in the chamber as liquid flows past the inner face of the resilient portion with the rigid part.