Fluid jet blood sampling device and methods

• US 6,030,399 A
• Filed: 06/04/1997
• Issued: 02/29/2000
• Est. Priority Date: 06/04/1997
• Status: Expired due to Fees

• Current Assignee: Altea Therapeutics Corporation (Nitto Denko Corporation)
• Original Assignee: Spectro Incorporated (Spectro Scientific, Inc.)
• Inventors: Ignotz, Keith D., Samuels, Mark A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US08/869,214
• Time in Patent Office: 1,000 Days
• Field of Search: 606/167, 606/181, 600/573, 600/583, 604/68-72, 604/22
• US Class Current: 606/167
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/15134 Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146

Abstract

A fluid jet blood sampling system and method for obtaining a blood sample from a mammal, utilizes a fluid jet from a disposable jet nozzle to perforate at least the epidermis of the skin and to break at least one blood vessel, thereby allowing a quantity of blood to accumulate on the skin surface of the mammal. A cowling prevents contamination of the local environment with excess fluid, blood, etc. A drying unit may be provided to remove excess fluid, blood, etc. from the skin within the cowling. A sample of blood may be transferred to a test strip, or a collection unit may be used to collect and contain a blood sample from the mammal.

Claims

1. A fluid jet blood sampling system, comprising:

a control unit for supplying a pressurized fluid at a pressure ranging from about 8,000 psi to about 11,000 psi;

a jet nozzle functionally coupled to said control unit, wherein the control unit and the jet nozzle are configured to eject the pressurized fluid as a fluid jet capable of perforating a patient'"'"'s skin; and

a sealing unit for containing at least one of the fluid from the fluid jet and an initial outflow of blood escaping the patient'"'"'s skin.

2. The fluid jet blood sampling system as claimed in claim 1, wherein the jet nozzle and sealing unit form an integrated jet nozzle/cowling unit.

3. The fluid jet blood sampling system as claimed in claim 2, wherein said integrated jet nozzle/cowling is disposable and is molded as a single piece of plastic.

4. The fluid jet blood sampling system as claimed in claim 2, wherein the integrated jet nozzle/cowling further comprises a channel unit for collecting at least one of the fluid from the fluid jet and the initial outflow of blood escaping the patient'"'"'s skin.

5. The fluid jet blood sampling system as claimed in claim 4, wherein the channel unit comprises at least one capillary tube arranged between the jet nozzle and the sealing unit.

6. The fluid jet blood sampling system as claimed in claim 4, wherein said integrated jet nozzle/cowling further includes a crown, said crown disposed circularly between said jet nozzle and said channel unit, said crown including one or more crown furrows for directing fluid toward said channel unit.

7. The fluid jet blood sampling system of claim 2, wherein the jet nozzle/cowling unit is disposable.

8. The fluid jet blood sampling system as claimed in claim 1, wherein said jet nozzle has a fluid aperture with a diameter ranging from about 50 to about 100 μ

m.

9. The fluid jet blood sampling system as claimed in claim 1, wherein the jet nozzle is capable of directing the fluid jet toward the patient'"'"'s skin at an acute angle relative to a skin surface.

10. The fluid jet blood sampling system as claimed in claim 9, wherein the angle is adjustable.

11. The fluid jet blood sampling system as claimed in claim 1, wherein the duration of the fluid jet is adjustable.

12. The fluid jet blood sampling system as claimed in claim 1, wherein the fluid includes at least one of an anti-bacterial agent, an anti-infective agent, and an anesthetic.

13. The fluid jet blood sampling system as claimed in claim 1, wherein the control unit is capable of supplying the pressurized fluid at varying pressures.

14. The fluid jet blood sampling system of claim 1, wherein the control unit and the jet nozzle are configured to produce a fluid jet that causes blood to collect on a surface of the patient'"'"'s skin.

15. The fluid jet blood sampling system of claim 1, further comprising a blood collection device configured to collect blood from the patient'"'"'s skin.

16. The fluid jet blood sampling system of claim 15, wherein the blood collection device comprises at least one blood collection capillary tube.

17. A blood sampling system, comprising:

a jet nozzle capable of emitting a fluid as a fluid jet, said fluid jet capable of perforating at least the epidermis of the skin of a patient at a locus such that a quantity of blood may flow from the skin of said patient at said locus;

a cowling surrounding said jet nozzle;

a collection unit for collecting a sample of said quantity of blood;

a trap unit for trapping unwanted materials; and

a drying unit for removing the unwanted materials from the trap unit.

18. The blood sampling system as claimed in claim 17, further comprising a pressure supply unit functionally connected to said jet nozzle for pressurizing said fluid.

19. The blood sampling system as claimed in claim 17, wherein said collection unit comprises a collection duct and a collection reservoir, said collection duct being coupled to said cowling and transferring said sample of said blood to said collection reservoir.

20. A method for making a fluid jet blood sampling system, the method comprising the steps of:

providing a pressure supply unit in a handpiece, wherein the pressure supply unit is configured to supply fluid at a pressure ranging from about 8,000 psi to about 11,000 psi;

functionally coupling the pressure supply unit to a fluid jet nozzle unit, wherein the pressure supply unit and the fluid jet nozzle unit are configured to output a fluid jet; and

attaching a cowling for trapping unwanted materials to the handpiece.

21. The method of claim 20, further comprising the steps of:

attaching a collection duct to the cowling; and

coupling a collection reservoir to the collection duct.

22. The method of claim 20, further comprising the steps of:

coupling a drying duct to the cowling; and

coupling a trap unit to the drying duct.

23. The method of claim 22, further comprising the step of coupling a drying vacuum unit to the trap unit to draw the unwanted materials through the drying duct into the trap unit.

24. A fluid jet system for obtaining a blood sample, comprising:

a control unit for supplying a pressurized fluid;

an integrated disposable jet nozzle/cowling functionally coupled to said control unit, wherein the jet nozzle/cowling is molded as a single piece of plastic, and wherein said integrated jet nozzle/cowling comprises;

a jet nozzle for emitting a fluid jet, and

a sealing ring, and

a drying unit comprising a channel located between said sealing ring and said jet nozzle.

25. The fluid jet system for obtaining a blood sample as claimed in claim 24, wherein said control unit supplies pressurized fluid to said integrated jet nozzle/cowling at pressure ranging from about 9,000 to about 10,000 psi.

26. The fluid jet system of claim 24, wherein the control unit supplies fluid to the integrated jet nozzle/cowling at pressures between approximately 8,000 psi and approximately 11,000 psi.

27. The fluid jet system of claim 24, further comprising a blood collection device.

28. The fluid jet system of claim 27, wherein the blood collection device comprises at least one capillary tube.

29. An integrated jet nozzle/cowling, comprising:

a jet nozzle having a jet nozzle distal end;

a channel unit; and

a sealing ring, wherein said integrated jet nozzle/cowling comprises a single piece of molded plastic.

30. The integrated jet nozzle/cowling as claimed in claim 29, wherein said sealing ring is substantially circular, said channel unit is substantially circular and lies within said sealing ring, and said jet nozzle distal end lies approximately central to said sealing ring.

31. The integrated jet nozzle/cowling as claimed in claim 29, further comprising a crown, said crown extending circularly from said jet nozzle distal end to said channel unit.

32. The integrated jet nozzle/cowling as claimed in claim 31, wherein said crown includes one or more crown furrows.

33. The integrated jet nozzle/cowling as claimed in claim 29, wherein said channel unit includes at least one channel having a width ranging from about 100 μ

m to about 2 mm.

34. The integrated jet nozzle/cowling as claimed in claim 29, wherein said jet nozzle distal end has a fluid passage having a diameter ranging from about 50 to about 100 μ

m.

35. The integrated jet nozzle/cowling as claimed in claim 29, wherein said single piece of molded plastic comprises one of polypropylene and polyethylene.

36. A method for obtaining a blood sample from beneath a surface of a patient'"'"'s skin, comprising the steps of:

providing a fluid jet blood sampling system including a control unit and an integrated jet nozzle/cowling, the integrated jet nozzle/cowling having a sealing ring and a jet nozzle for providing a fluid jet capable of forming a hole in skin;

placing the sealing ring on the skin surface;

by means of the fluid jet, forming a hole in the patient'"'"'s skin;

allowing at least one drop of blood to accumulate on a surface of the patient'"'"'s skin; and

collecting a sample of the at least one drop of blood.

37. The method of claim 36, further comprising the step of removing the sealing ring from the skin surface before collecting the sample of the at least one drop of blood.

38. The method of claim 37, wherein said step of collecting a sample of the at least one drop of blood comprises collecting a sample of the at least one drop of blood with a secondary device.

39. The method of claim 37, wherein said step of collecting a sample of the at least one drop of blood comprises collecting a sample of the at least one drop of blood on a test strip.

40. The method of claim 37, wherein said step of collecting a sample of the at least one drop of blood comprises collecting a sample of the at least one drop of blood with a narrow bore tube.

41. The method of claim 36, further comprising the step of breaking a blood vessel beneath the surface of the patient'"'"'s skin with the fluid jet.

42. A method for obtaining a blood sample from a patient, comprising the steps of:

aiming a jet nozzle of a fluid jet unit at a locus on the skin of the patient;

propelling a fluid jet at the locus with the jet nozzle;

perforating the skin of the patient at the locus with the fluid jet;

breaking at least one blood vessel beneath the perforated skin at the locus by means of the fluid jet; and

allowing a first quantity of blood to accumulate at the locus.

43. The method of claim 42, further comprising the step of collecting a sample of the first quantity of blood.

44. The method of 42, further comprising the steps of:

removing the fluid and the first quantity of blood from the locus;

allowing a second quantity of blood to accumulate at the locus; and

collecting a sample of the second quantity of blood.

45. A method for collecting a blood sample from a patient, comprising the steps of:

propelling a fluid jet at a locus on a skin of the patient whence the blood sample is to be removed, wherein the fluid jet causes perforation of the skin at the locus on the skin of the patient and wherein at least one blood vessel located beneath the perforation of the skin is opened to permit a quantity of blood to accumulate at the locus on the skin; and

thereafter, collecting a sample of the quantity of blood.

46. The method of claim 45, further comprising the steps of:

allowing a first quantity of blood to accumulate on the skin after the fluid jet causes perforation of the skin;

removing unwanted material, including the first quantity of blood, from the locus on the skin after the fluid jet causes perforation of the skin; and

allowing a second quantity of blood to accumulate at the locus after the unwanted material has been removed, wherein the step of collecting a sample of the quantity of blood comprises collecting a sample of the second quantity of blood.

47. The method of claim 46, wherein the unwanted material is removed by applying suction with a drying vacuum unit.

48. The method of claim 46, wherein said collecting step comprises transferring a sample of the second quantity of blood from the locus on the skin to a collection reservoir via a collection duct.

49. A method of claim 46, further comprising the step of positioning a cowling over the locus on the skin before propelling a fluid jet at the locus on the skin, wherein the cowling is sealably attached to a barrel portion of the fluid jet device.

50. A method for assembling a fluid jet blood sampling system, comprising the steps of:

providing a fluid unit configured to eject a short duration fluid jet, wherein the fluid jet unit comprises a handpiece; and

attaching an integrated jet nozzle/cowling to the handpiece of the fluid jet unit, wherein

the jet nozzle/cowling comprises a single piece of molded plastic.

51. The method for assembling a fluid jet blood sampling system as claimed in claim 50, further comprising the step of coupling a drying conduit to the integrated jet nozzle/cowling.

52. The method of claim 50, further comprising the step of attaching a collection assembly to the integrated jet nozzle/cowling.