Intravascular blood parameter sensing system

• US 5,421,328 A
• Filed: 05/20/1994
• Issued: 06/06/1995
• Est. Priority Date: 06/29/1992
• Status: Expired due to Fees

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: 3M Company
• Inventors: Bedingham, William
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): GREEN, BRIAN
• Application Number:
  US08/247,025
• Time in Patent Office: 382 Days
• Field of Search: 128/632, 128/692, 128/634, 128/637, 128/DIG. 1, 604/154, 604/181, 604/218, 604/152, 604/183, 92/13.1, 92/80, 92/209
• US Class Current: 600/309
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/6852 Catheters

Abstract

A parameter of blood is sensed in vivo with a system which includes a catheter and a probe. The catheter has a lumen extending therethrough, a proximal end, a distal end and a distal opening at the distal end. The probe includes one or more sensing elements at its distal end. In one embodiment, the sensing element or elements are located at least about 4 mm proximal of the distal opening of the lumen. A volume oscillator is provided to control the movement of blood into and out of the lumen. A flush solution is introduced into the lumen so that when the volume oscillator is inactive the sensing element or elements are exposed to pure flush solution, which preferably includes an anti-clotting component. The probe is received within the catheter and affixed thereto. The volume oscillator is activated to move blood into and out of the lumen to expose the sensing element or elements to blood so that they can sense the blood parameter or parameters of interest.

Claims

1. An assembly for the sensing of a blood parameter and for controlling the flow of blood from a blood vessel of a patient into and out of a lumen of a catheter, said assembly comprising:

a sensing element for sensing a parameter of blood and providing a signal in response thereto;

a catheter having a proximal end, a distal end, and a lumen extending therethrough, said distal end being sized and adapted so as to be receivable within a blood vessel of a patient, said sensing element being located within said lumen; and

a volume oscillator in fluid communication with said lumen, said volume oscillator being configured so as to be capable of being connected to a flush solution source so as to allow for the flow of flush solution from said flush solution source, through said volume oscillator, and into said lumen, said volume oscillator comprising;

a housing defining a fluid flow path in fluid communication with said lumen and capable of being placed in fluid communication with said flush solution source;

a piston moveable relative to said housing and together with said housing defining a chamber of variable volume, said chamber being in fluid communication with said fluid flow path;

a stem secured to said piston and adapted to be activated to move said piston relative to said housing to thereby vary the volume of said chamber; and

means for activating said stem in a predetermined time sequence so that the volume of said chamber varies with time in accordance with a wave form.

2. The assembly of claim 1 wherein said wave form is such that the amount of blood in said lumen is maintained substantially constant for a portion of the time said stem is activated.

3. The assembly of claim 1 wherein said wave form is such that the amount of blood in said lumen is maintained substantially constant for a major portion of the time said stem is activated.

4. The assembly of claim 1 wherein said activating means comprises an actuator removeably coupled to said stem and wherein said housing, piston, and stem are separatable from said assembly such that they can be disposed of after use with a single patient.

5. The assembly of claim 4 wherein said actuator includes a motor with a motor shaft which is removeably coupled to said stem, and a control system in electrical communication with said motor to provide control information to said motor to control said motor, and thereby control the time sequence in which said stem is activated.

6. The assembly of claim 5 wherein said control system includes a microprocessor adapted to be preprogrammed to provide said control information.

7. The assembly of claim 5 wherein said motor is a stepping motor and said control system is adapted to control said motor to at least reduce the magnitude of the individual steps taken by said motor.

8. The assembly of claim 4 further comprising a holder which carries said housing and at least a portion of said actuator.

9. The assembly of claim 8 wherein said holder includes a cavity which receives and holds said housing, and said holder and said housing include first and second positioning elements, respectively, which are adapted to be mutually engaged to hold said housing in said cavity.

10. The assembly of claim 1 wherein said wave form is that wave form set forth in FIG. 10 herein.