Method and apparatus for arterial and venous blood sampling

• US 4,763,648 A
• Filed: 09/12/1986
• Issued: 08/16/1988
• Est. Priority Date: 09/12/1986
• Status: Expired due to Term

• Current Assignee: Philip, Los Angeles Wyatt
• Original Assignee: Migada Incorporated
• Inventors: Wyatt, Philip
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/907,118
• Time in Patent Office: 704 Days
• Field of Search: 128/760, 128/762-768, 128/770-771, 128/673, 128/748, 604/200-204, 604/205
• US Class Current: 600/486
• CPC Class Codes: A61B 5/15003 for venous or arterial 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 5/150992 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: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Abstract

A method and apparatus for arterial and venous blood sampling is described. The apparatus includes efficient structure for purging the fluid line and a fluid sampling device chamber of residue heparinized IV solution to obtain a sufficiently undiluted blood sample without excessive blood waste and risk of entry of air, line contamination/nosocomial infection or misdiagnosis. The apparatus is also specially designed to protect the clinician from either self-contamination from patient fluids or accidental injury from needle puncture.

Claims

1. An apparatus for use in conjunction with an arterial or venous pressure monitoring system which is interconnected invasively to a patient for obtaining a blood sample from the patient, said monitoring system being characterized by having a catheter adapted to be inserted into a vein or artery of the patient, a remote fluid supply means for administering fluid to the patient via a fluid conduit interconnecting the catheter and the fluid supply and a valve disposed within the fluid conduit intermediate the fluid supply means and the catheter for controlling the flow of fluid through the fluid conduit, said apparatus comprising first and second spaced apart, operably interconnected, fluid sampling devices, each of said fluid sampling devices being independently accessible to withdraw fluid from within the system and each comprising a body having an upper and lower chamber, said lower chamber having first and second fluid ports;

and sealing means carried by said upper chamber for sealing said lower chamber relative to atmosphere, said sealing means being penetrable by a needle of a syringe to gain access to said lower chamber;

said first sampling device including first connector means for interconnecting said first fluid port of said body of said first fluid sampling device with the valve of the pressure monitoring system; and

said second fluid sampling device including second connector means for interconnecting said second fluid port of said body of said second fluid sampling device with the catheter of the pressure monitoring system, whereby said valve can be closed to block fluid flow toward the catheter, said lower chamber of said first fluid sampling device can be accessed by a first syringe to withdraw from the apparatus all fluid contained between the catheter and the lower chamber of the first sampling device and to withdraw blood from the patient in a quantity sufficient to draw blood past said lower chamber of said second fluid sampling device and then said lower chamber of said second fluid sampling device can be accessed by a second syringe to withdraw therefrom the undiluted blood contained therewithin.

2. An apparatus as defined in claim 1 in which said sealing means comprises an injection site for penetration by a needle of a hypodermic syringe.

3. An apparatus as defined in claim 1 in which said sealing means comprises a diaphragm constructed of natural rubber.

4. An apparatus as defined in claim 1 in which said sealing means comprises a diaphragm constructed of synthetic rubber.

5. An apparatus as defined in claim 1 in which said body is constructed of a substantially transparent material whereby the interior of said lower chamber is visible from the exterior of the apparatus.

6. An apparatus as defined in claim 1 in which said body includes gripping means for gripping said fluid sampling device between the thumb and a finger and shield means disposed between said gripping means and said upper chamber for protecting the thumb and finger against accidental puncture by the object used to penetrate said sealing means.

7. An apparatus as defined in claim 6 in which said gripping means comprises a first generally planar member disposed on a plane extending downwardly from said lower chamber and in which said shield means comprises a second generally planar member disposed in a plane generally perpendicular to the plane of said first generally planar member.

8. An apparatus for use in conjunction with an arterial or venous pressure monitoring system which has been interconnected invasively to a patient for obtaining a blood sample from the patient, said monitoring system being characterized by having a catheter adapted to be inserted into a vein or artery of the patient, a remote fluid supply means for administering fluid to the patient via fluid conduits interconnecting the catheter and the fluid supply and at least one valve disposed within the fluid conduit intermediate the fluid supply means and the catheter for controlling the flow of fluid through the fluid conduits, said apparatus comprising first and second spaced apart, operably interconnected, fluid sampling devices, each of said fluid sampling devices comprising:

(a) a body having an upper and lower chamber, said lower chamber having curved bottom and side walls and first and second fluid ports formed in said side walls;

(b) a septum sealably carried within said upper chamber dividing said upper and lower chambers and sealing said lower chamber with respect to atmosphere, said septum being penetrable by a sharp object to access said lower chamber;

(c) gripping means carried by said body for gripping said fluid sampling device between the thumb and a finger; and

(d) shield means carried by said body and disposed between said gripping means and said upper chamber for protecting the thumb and finger of the user against accidental puncture by the needle of the hypodermic syringe during penetration of said septum, said shield means comprising a rigid member extending outwardly from said body a substantial distance to substantially cover the thumb and finger of the user said first sampling device including first connector means for interconnecting said first fluid port of said body of said first fluid sampling device with the valve of the pressure monitoring system; and

said second fluid sampling device including second connector means for interconnecting said second fluid port of said body of said second fluid sampling device with the catheter of the pressure monitoring system.

9. An apparatus as defined in claim 8 in which said gripping means comprises a first generally planar member disposed in a plane extending downwardly from said body and in which said shield means comprises a second generally planar member carried by said body and disposed in a plane generally perpendicular to the plane of said first generally planar member.

10. An apparatus as defined in claim 9 in which said planar member is provided with a cutout area proximate said lower chamber.

11. An apparatus as defined in claim 8 further including a cap member having a central aperture closely receivable over the upper portion of said body of said first and second fluid sampling devices.

12. An apparatus as defined in claim 11 in which said cap of said first fluid sampling device is of a first color and said cap of said second fluid sampling device is of a second color.

13. A fluid sampling device for interconnection within an arterial or venous pressure monitoring system which has been interconnected invasively to a patient for obtaining a blood sample from the patient, said monitoring system being characterized by having a catheter adapted to be inserted into a vein or artery of the patient, and an elongated fluid conduit interconnected to the catheter, said fluid sampling device being operably interconnected within said elongated fluid conduit at a location remote from the catheter and comprising:

(a) a body having an upper and lower chamber, said lower chamber having first and second fluid ports;

(b) a septum sealably carried within said upper chamber dividing said upper and lower chambers and sealing said lower chamber with respect to atmosphere, said septum being penetrable by a sharp object to access said lower chamber;

(c) gripping means carried by said body for gripping said fluid sampling device between the thumb and a finger; and

(d) shield means carried by said body and disposed between said gripping means and said upper chamber for protecting the thumb and finger of the user against accidental puncture by the needle of the hypodermic syringe during penetration of said septum said shield means comprising a generally rigid planar member protruding transversely and longitudinally outwardly from said body a substantial distance to cover the thumb and finger of the user.

14. A fluid sampling device as defined in claim 13 in which said lower chamber is constructed of a substantially transparent plastic and comprises interconnected curved bottom and side walls, said first and second fluid ports being formed in said side walls.

15. A method of obtaining a blood sample from a patient in conjunction with an atmospherically sealed, arterial or venous pressure monitoring system which is interconnected invasively with the patient and which comprises a catheter adapted to be inserted into either a vein or artery of the patient, a remote fluid supply for delivery of fluid to the patient, a fluid conduit interconnecting the fluid supply and the catheter, and a valve disposed within the fluid conduit intermediate the fluid supply and the catheter, said method comprising the steps of:

(a) closing the valve to block fluid flow from the fluid supply means toward the catheter;

(b) while maintaining the seal to atmosphere, accessing the fluid conduit at a first location intermediate the catheter and the valve;

(c) removing the fluid contained within the system between the valve and the catheter;

(d) drawing undiluted blood from the patient to fill the system between the catheter and said first location with the undiluted blood of the patient;

(e) while maintaining the seal to atmosphere, accessing the fluid conduit at a second location intermediate the catheter and said first location; and

(f) drawing from the fluid conduit a predetermined volume of undiluted blood.

16. A method as defined in claim 15 including the further step of opening the valve to permit fluid flow toward the catheter whereby the blood remaining in the system will be delivered back to the patient.

17. A method of obtaining a blood sample from a patient in conjunction with an arterial or venous pressure monitoring system which comprises a catheter adapted to be inserted into either a vein or artery of the patient, first and second spaced apart fluid chambers interconnected with the catheter by a fluid conduit, the chambers being closed to atmosphere, but accessible by the needle of a syringe, fluid supply means for introducing fluid into the monitoring system for delivery to the patient via the first and second chambers and the catheter and a valve disposed between the fluid supply means and the first chamber, said method comprising the steps of:

(a) closing the valve to block fluid flow from the fluid supply means toward the first chamber;

(b) accessing the first chamber with the needle of a first syringe and through use of said first syringe removing from the monitoring system the fluid contained within the first and second chambers and the conduit interconnecting said chambers with the catheter;

(c) through use of said first syringe, filling the first and second chambers and the interconnecting conduit with blood drawn from the patient;

(d) accessing the second chamber with the needle of a second syringe and through use of said second syringe removing a predetermined volume of blood from said second chamber;

(e) removing the needle of the first syringe from the first chamber; and

(f) opening the valve to permit fluid flow from the fluid supply means toward the first chamber whereby the blood remaining in the monitoring system is caused to flow into the patient via the catheter.

18. An apparatus for use in conjunction with an arterial or venous pressure monitoring system which is closed to atmosphere and interconnected invasively to a patient for obtaining a blood sample from the patient, said monitoring system being characterized by having a catheter adapted to be inserted into a vein or artery of the patient, a remote fluid supply means for administering fluid to the patient via a fluid conduit interconnecting the catheter and the fluid supply and flow control means disposed in line within the fluid conduit intermediate the fluid supply means and the catheter for regulating the flow of fluid through the fluid conduit, said apparatus comprising first and second spaced apart, operably interconnected, access devices, each of said access devices permitting smooth, laminar fluid flow therethrough and being independently accessible to withdraw fluid from within the system without opening the system to atmosphere and each comprising a body having an upper and lower chamber, said lower chamber having first and second fluid ports;

and sealing means carried by said upper chamber for sealing said lower chamber relative to atmosphere, said first access device including first connector means for interconnecting said first fluid port of said body of said first access device with the flow control means of the pressure monitoring system; and

said second access device including second connector means for interconnecting said second fluid port of said body of said second access device with the catheter of the pressure monitoring system, whereby said lower chamber of said first access device can be accessed to withdraw from the apparatus all fluid contained between the catheter and the lower chamber of the lower access device and to withdraw blood from the patient in a quantity sufficient to draw blood past said second chamber of said second access device and then said lower chamber of said second fluid sampling device can be accessed to withdraw therefrom undiluted blood contained therewithin.

19. A method of obtaining a blood sample from a patient in conjunction with an atmospherically sealed, arterial or venous pressure monitoring system which is interconnected invasively with the patient and which comprises a catheter inserted into either a vein or artery of the patient, a remote fluid supply for delivery of fluid to the patient, a fluid conduit interconnecting the fluid supply and the catheter, and fluid flow control means disposed within the system for controlling the flow of fluid toward the catheter, said method comprising the steps of:

(a) using the fluid flow control means restricting fluid flow from the fluid supply means toward the catheter;

(b) while maintaining the seal to atmosphere, accessing the fluid conduit at a first location intermediate the catheter and the fluid control means;

(c) removing the fluid contained within the system between said first location and the catheter;

(d) drawing undiluted blood from the patient to fill the system between the catheter and said first location with the undiluted blood of the patient;

(e) while maintaining the seal to atmosphere, accessing the fluid conduit at a second location intermediate the catheter and said first location; and

(f) drawing from the fluid conduit a predetermined volume of undiluted blood.