Pressure-measuring method and needle system for hemodialysis

• US 5,454,374 A
• Filed: 01/17/1992
• Issued: 10/03/1995
• Est. Priority Date: 01/17/1992
• Status: Expired due to Fees

• Current Assignee: Rodney S. Omachi
• Original Assignee: Rodney S. Omachi
• Inventors: Omachi, Rodney S.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US07/822,416
• Time in Patent Office: 1,355 Days
• Field of Search: 73/708, 73/714, 73/756, 116/DIG. 47, 116/281, 116/283, 116/341, 128/674, 128/673, 128/675, 128/, 128/684
• US Class Current: 600/486
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02156 Calibration means

Abstract

A method and devices for measuring pressure within blood vessels used for hemodialysis and also for flow of blood into or from such blood vessels during hemodialysis. In one aspect of the method, a currently available hemodialysis set is used. This set comprises a tube (14) attached at one end to a hollow needle (12) and closed at the other end by a cap (19) which covers a proximal connector (18). The method comprises puncturing the blood vessel with the needle (12), measuring the distance to which blood flows under pressure into tube (14), calculating that pressure from that distance, and finally using the hemodialysis set for flow of blood in the performance of hemodialysis. In other aspects of the method, the improved devices of the invention are used. In one embodiment a proximal portion comprising a hollow needle (12), tube (14) with calibrated markings (16) and a proximal connector (18) are attached to a distal portion comprising a male connector (32) with lumen occluded by a hollow needle with a capillary lumen (34) and closed cylinder (24). The improvements in this embodiment increase the length of tube filled by blood and decrease the fluctuation in that length as a result of change in pressure between systole and diastole. In another embodiment a one-way flap valve (50) allows measurement of the maximum or systolic pressure within the blood vessel. In other embodiments pressure measurements are normalized for different atmospheric pressures at different altitudes. After the measurement of pressure, the needle, tube, and proximal connector are used for withdrawal or return of blood for a hemodialysis treatment.

Claims

1. A medical device for measuring pressure within blood vessels used for hemodialysis and also for withdrawing or returning blood in the performance of hemodialysis, comprising:

(a) means for puncturing said vessels located at a proximal end of said medical device;

(b) a tube attached to said puncturing means;

(c) blood pressure measuring means, associated with said tube, comprising reference means for measuring a distance to which a column of blood has entered said tube, said reference means comprising a plurality of calibrated markings placed upon said tube at positions corresponding to different pressures within said blood vessels, said plurality of calibrated markings being distinguishable in a plurality of sets each corresponding to a different altitude at which said medical device is used;

(d) a first connector attached to a distal end of said tube;

(e) a second connector forming with said first connector an air-tight connection;

(f) a closed chamber, attached to said second connector, that defines a non-expansible volume.

2. A blood pressure measuring kit for measuring pressure within blood vessels used for hemodialysis and also for withdrawing or returning blood in the performance of hemodialysis, comprising:

(a) means for puncturing said vessels

(b) a tube attached to said puncturing means;

(c) a first connector attached to a distal end of said tube;

(d) a second connector forming with said first connector an air-tight connection;

(e) a closed chamber, attached to said second connector, that defines a non-expansible volume;

(f) blood pressure measuring means, associated with but not attached to said tube, comprising reference means for measuring a distance to which a column of blood has entered said tube, said reference means comprising an essentially flat strip of material placed adjacent said tube, said strip having a plurality of calibrated markings placed at positions corresponding to different pressures within said blood vessels, said plurality of calibrated markings being distinguishable in a plurality of sets each corresponding to a different altitude at which said blood pressure measuring kit is used.

3. A medical device for measuring pressure within blood vessels used for hemodialysis and also for withdrawing or returning blood in the performance of hemodialysis, comprising:

(a) means for puncturing said vessels located at a proximal end of said medical device;

(b) a tube attached to said puncturing means;

(c) blood pressure measuring means, associated with said tube, comprising reference means for measuring a distance to which a column of blood has entered said tube;

(d) a first connector attached to a distal end of said tube;

(e) a second connector forming with said first connector an air-tight connection;

(f) a closed chamber, attached to said second connector, that defines a non-expansible volume;

(g) means for producing greater resistance to flow of air between said tube and said closed chamber than the resistance to flow of air within said tube.

4. The medical device of claim 3 wherein said means for producing greater resistance to flow of air between said tube and said closed chamber than the resistance to flow of air within said tube comprises a capillary lumen within said second connector.

5. The medical device of claim 3 wherein said second connector contains a lumen and wherein said means for producing greater resistance to flow of air between said tube and said closed chamber than the resistance to flow of air within said tube comprises a porous material filling said lumen.

6. A blood pressure measuring kit for measuring pressure within blood vessels used for hemodialysis and also for withdrawing or returning blood in the performance of hemodialysis, comprising:

(a) means for puncturing said vessels;

(b) a tube attached to said puncturing means;

(c) a first connector attached to a distal end of said tube;

(d) a second connector forming with said first connector an air-tight connection;

(e) a closed chamber, attached to said second connector, that defines a non-expansible volume;

(f) means for producing greater resistance to flow of air between said tube and said closed chamber than the resistance to flow of air within said tube;

(g) blood pressure measuring means, associated with but not attached to said tube, comprising reference means for measuring a distance to which a column of blood has entered said tube, said reference means comprising an essentially flat strip of material placed adjacent said tube, said strip having a plurality of calibrated markings placed at positions corresponding to different pressures within said blood vessels.

7. A medical device for measuring pressure within blood vessels used for hemodialysis and also for withdrawing or returning blood in the performance of hemodialysis, comprising:

(a) means for puncturing said vessels located at a proximal end of said medical device;

(b) a tube attached to said puncturing means;

(c) blood pressure measuring means, associated with said tube, comprising reference means for measuring a distance to which a column of blood has entered said tube;

(d) a first connector attached to a distal end of said tube;

(e) a second connector forming with said first connector an air-tight connection;

(f) a closed chamber, attached to said second connector, that defines a non-expansible volume;

(g) means for allowing flow of air only in one direction from said tube into said closed chamber and for preventing flow of air from said closed chamber into said tube.

8. The medical device of claim 7 wherein said second connector contains a lumen, wherein said closed chamber has a base, wherein said lumen has an opening into said base of said closed chamber and wherein said means for allowing flow of air only in one direction from said tube into said closed chamber and for preventing flow of air from said closed chamber into said tube comprises a thin, flexible disk which is impermeable to air, is attached around a portion of its circumference to said base of said closed chamber, and overlies said opening of said lumen of said second connector into said closed chamber.

9. A blood pressure measuring kit for measuring pressure within blood vessels used for hemodialysis and also for withdrawing or returning blood in the performance of hemodialysis, comprising:

(a) means for puncturing said vessels;

(b) a tube attached to said puncturing means;

(c) a first connector attached to a distal end of said tube;

(d) a second connector forming with said first connector an air-tight connection;

(e) a closed chamber, attached to said second connector, that defines a non-expansible volume;

(f) means for allowing flow of air only in one direction from said tube into said closed chamber and for preventing flow of air from said closed chamber into said tube;

(g) blood pressure measuring means, associated with but not attached to said tube, comprising reference means for measuring a distance to which a column of blood has entered said tube, said reference means comprising an essentially fiat strip of material placed adjacent said tube, said strip having a plurality of calibrated markings placed at positions corresponding to different pressures within said blood vessels.