Method and device for monitoring loss of body fluid and dislodgment of medical instrument from body

• US 20050038325A1
• Filed: 08/13/2003
• Published: 02/17/2005
• Est. Priority Date: 08/13/2003
• Status: Active Grant

• Current Assignee: Bradley JON MOLL Rodney L MOLL and Ann E MOLL Family Trust
• Original Assignee: Bradley JON MOLL Rodney L MOLL and Ann E MOLL Family Trust
• Inventors: Moll, Bradley Jon
• Granted Patent: US 6,979,306 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor

Abstract

A method of alerting medical personnel of a problem during hemodialysis includes providing an active, fail-to-safe site sensor for a fistula needle at an access site during hemodialysis; and automatically alerting medical personnel of a problem during hemodialysis using the active, fail-to-safe site sensor during at least the following: failing of the active, fail-to-safe site sensor; insufficient powering to the active, fail-to-safe site sensor; partial fistula needle dislodging from the access site; and complete needle dislodging from the access site.

Claims

1. A hemodialysis site sensor attachable to at least one of a blood line and a fistula needle for alerting medical personnel of the leakage of blood from an access site where the fistula needle enters into a patient'"'"'s body and dislodgment of the fistula needle from the access site, the hemodialysis site sensor comprising:

a base membrane layer made of a medical-grade, biocompatible material and including an upper side, a lower side adherable to skin of the patient, and one or more holes disposed therein to allow the passage of blood and vapor therethrough;

a second membrane layer including an upper side, a lower side, and one or more holes disposed therein to allow the passage of blood and vapor therethrough;

a third membrane layer including an upper side and a lower side;

an electrical connection adapted to be electrically coupled to an analytical circuit and including

a first sensing array disposed between the upper side of the base membrane layer and the lower side of the second membrane layer,

a second sensing array disposed between the upper side of the second membrane layer and the lower side of the third membrane layer, and resistively connected to the first sensing array;

a disconnection mechanism attachable to at least one of the blood line and the fistula needle and severing the electrical connection upon dislodgment of the fistula needle from the access site;

wherein an electrical signal sent through the electrical connection changes when blood contacts at least one of the sensing arrays or the electrical connection is severed by the disconnection mechanism, causing the analytical circuit to actuate an alarm notifying medical personnel of partial or total dislodgment of the fistula needle from the access site.

2. The hemodialysis site sensor of claim 1, wherein the disconnection mechanism includes an adhesive tab attachable to at least one of the blood line and the fistula needle, and a perforation along the membrane layers so that upon dislodgment of the fistula needle, the dislodgment mechanism separates from the site sensor along the perforation, causing the electrical connection to be severed.

3. The hemodialysis site sensor of claim 1, wherein the electrical connection include a conductive wire that wraps around a patient'"'"'s limb where the access site is.

4. A method of alerting medical personnel of partial and total dislodgment of a fistula needle from an access site where the fistula needle enters into a patient'"'"'s body during hemodialysis, comprising:

providing a site sensor including a base membrane layer made of a medical-grade, biocompatible material and including a lower side adherable to skin of the patient at the access site, and one or more holes disposed therein to allow the passage of blood and vapor therethrough, a top membrane layer, an electrical connection including one or more resistively connected sensing arrays disposed between the base membrane layer and the top membrane layer, and a disconnection mechanism attachable to at least one of the blood line and the fistula needle and severing the electrical connection upon dislodgment of the fistula needle from the access site;

providing an analytical circuit in electrical communication with the electrical connection;

sending a signal from the analytical circuit to the site sensor and receiving the signal from the site sensor with the analytical circuit, the signal traveling through the one or more resistively connected sensing arrays of the electrical connection;

partially dislodging the fistula needle from the access site causing blood to contact the one or more resistively connected sensing arrays and the signal sent from the analytical circuit to change;

completely dislodging the fistula needle from the access site causing the disconnection mechanism to sever the electrical connection and the signal sent from the analytical circuit to change;

determining with the analytical circuit whether the signal changed outside of a predetermined range;

actuating an alarm with the analytical circuit if the signal changed outside of a predetermined range.

5. The method of claim 4, wherein the disconnection mechanism includes an adhesive tab attachable to at least one of the blood line and the fistula needle, and a perforation along the membrane layers, and severing the electrical connection with the disconnection mechanism includes severing the electrical connection by at least one of the blood line and the fistula needle pulling on the adhesive tab and separating the dislodgment mechanism from the site sensor along the perforation, causing the electrical connection to be severed.

6. The method of claim 5, wherein the site sensor further includes a first membrane layer including one or more holes disposed therein to allow the passage of blood and vapor therethrough, and the one or more resistively connected sensing arrays include a first sensing array disposed between the base membrane layer and the first membrane layer, and a second sensing array disposed between the first membrane layer and the top membrane layer.

7. The method of claim 5, further including resetting the site sensor in the event of false alarm.

8. A method of alerting medical personnel of a problem during hemodialysis, comprising:

providing an active, fail-to-safe site sensor for a fistula needle at an access site during hemodialysis;

automatically alerting medical personnel of a problem during hemodialysis using the active, fail-to-safe site sensor during at least the following;

failing of the active, fail-to-safe site sensor;

insufficient powering to the active, fail-to-safe site sensor;

partial fistula needle dislodging from the access site; and

complete needle dislodging from the access site.

9. The method of claim 8, wherein the active, fail-to-safe site sensor includes an active electric circuit and a disconnection mechanism attached to at least one of a blood line and the fistula needle that opens the active electric circuit of the active, fail-to-safe site sensor during complete needle dislodgment, and complete needle dislodging from the access site includes causing the disconnection mechanism to open the active electric circuit of the active, fail-to-safe site sensor.

10. The method of claim 8, wherein the active, fail-to-safe site sensor includes a base membrane layer made of a medical-grade, biocompatible material and including a lower side adherable to skin of the patient, and one or more holes disposed therein to allow the passage of blood and vapor therethrough, a top membrane layer, an electrical connection including one or more resistively connected sensing arrays disposed between the base membrane layer and the top membrane layer, and an analytical circuit in electrical communication with the one or more resistively connected sensing arrays of the electrical connection and sending an electrical signal therethrough, and automatically alerting medical personnel of a problem during hemodialysis using the active, fail-to-safe site sensor when the difference between the electrical signal sent by the analytical circuit and the electrical signal received by the analytical circuit is beyond a predetermined range.

11. The method of claim 10, wherein the active, fail-to-safe site sensor further includes a first membrane layer including one or more holes disposed therein to allow the passage of blood and vapor therethrough, and the one or more resistively connected sensing arrays include a first sensing array disposed between the base membrane layer and the first membrane layer, and a second sensing array disposed between the first membrane layer and the top membrane layer.

12. The method of claim 8, further including resetting the site sensor in the event of false alarm.