Method and device for detecting extravasation

• US 6,425,878 B1
• Filed: 02/28/2001
• Issued: 07/30/2002
• Est. Priority Date: 02/28/2001
• Status: Expired due to Fees

• Current Assignee: LG Medical Limited (LG Corporation)
• Original Assignee: LG Medical Limited (LG Corporation)
• Inventors: Shekalim, Avraharn
• Primary Examiner(s): Brinson, Patrick
• Application Number:
  US09/793,882
• Time in Patent Office: 517 Days
• Field of Search: 604/65, 604/66, 604/67, 604/503, 600/382, 600/549, 600/561, 600/384, 600/393, 600/372
• US Class Current: 604/65
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

A method and device for detecting extravasation employs a non-invasive sensor system deployed on the skin to identify changes in both subcutaneous interstitial fluid pressure and skin temperature. Preferably, the system monitors the sensor system outputs to identify a sequence of a skin temperature drop followed by a interstitial fluid pressure increase. This pattern is distinctive of the occurrence of extravasation, thereby providing very reliable detection. Most preferably, a simple sensor structure based upon multiple piezoelectric film sensors is used.

Claims

1. A method for detecting extravasation of a fluid delivered from the tip of a catheter into tissue located under a first region of skin, the method comprising:

(a) deploying on the skin a sensor system including;

(i) a first sensor including a layer of piezoelectric film disposed in thermal and mechanical connection with the first region of skin, the first sensor providing a sensing signal,

(ii) a second sensor including a layer of piezoelectric film disposed in mechanical connection with, but thermally isolated from, a second region of skin, the second sensor providing a reference signal, and

(iii) a third sensor including a layer of piezoelectric film disposed in mechanical connection with, but thermally isolated from, a third region of skin, the third sensor providing a gate signal;

(b) subtracting the reference signal from the sensing signal to generate a corrected sensing signal and from the gate signal to generate a corrected gate signal;

(c) when an amplitude of the corrected gate signal is no greater than a predefined gate threshold value, monitoring the corrected sensing signal to detect at least one variation indicative of a malfunction; and

(d) when an amplitude of the corrected gate signal is greater than the predefined gate threshold value, temporarily disregarding variations in the corrected sensing signal.

2. The method of claim 1, wherein said at least one variation indicative of a malfunction includes a sequence of two variations occurring between 0.1 seconds and 100 seconds apart.

3. The method of claim 1, wherein said at least one variation indicative of a malfunction includes a sequence of two variations occurring between 0.5 seconds and 10 seconds apart.

4. A method for detecting extravasation of a fluid delivered from the tip of a catheter into tissue located under a first region of skin, the method comprising:

(a) deploying on the skin a non-invasive sensor system including at least one sensor producing at least one output, said sensor system being operative to identify changes in both subcutaneous interstitial fluid pressure in said first region of skin and a skin temperature;

(b) monitoring said at least one output to identify a sequence of variations in said at least one output corresponding to a skin temperature drop followed by a interstitial fluid pressure increase; and

(c) generating an alarm condition when said sequence of variations occurs.

5. The method of claim 4, wherein said at least one sensor includes at least one measuring sensor and a gate sensor, said gate sensor producing an output indicative of disruptive motion likely to adversely affect an output of said at least one measuring sensor, the method further comprising disregarding the output of said at least one measuring sensor when said output of said gate sensor indicates the occurrence of disruptive motion.

6. The method of claim 4, wherein said at least one sensor includes a piezoelectric film primary sensor sensitive simultaneously to variations in interstitial fluid pressure and skin temperature.

7. The method of claim 6, wherein said sensor system further includes a piezoelectric film reference sensor insulated so as to be unaffected by variations in the skin temperature, an output from said reference sensor being subtracted from an output from said primary sensor.

8. A system for detecting extravasation of a fluid delivered from the tip of a catheter into tissue located under a first region of skin, the system comprising:

(a) a sensor system for non-invasive deployment on the skin, the sensor system including;

(i) a first sensor including a layer of piezoelectric film configured to be disposed in thermal and mechanical connection with the first region of skin, the first sensor providing a sensing signal,

(ii) a second sensor including a layer of piezoelectric film configured to be disposed in mechanical connection with, but thermally isolated from, a second region of skin, the second sensor providing a reference signal, and

(iii) a third sensor including a layer of piezoelectric film configured to be disposed in mechanical connection with, but thermally isolated from, a third region of skin, the third sensor providing a gate signal; and

(b) a processing system electrically coupled to said first second and third sensors, said processing system including;

(i) a first differencing module configured to subtract the reference signal from the sensing signal to generate a corrected sensing signal,

(ii) a second differencing module configured to subtract the reference signal from the gate signal to generate a corrected gate signal,

(iii) a comparator module configured to compare a current amplitude of the corrected gate signal with a predefined gate threshold value, and

(iv) a monitoring module configured to monitor the corrected sensing signal during periods when said comparator module determines that said corrected gate signal is no greater than said threshold value to detect at least one variation in said corrected sensing signal indicative of a malfunction.

9. The system of claim 8, further comprising a closure device associated with said processing system and with a conduit supplying the fluid to the catheter, said closure device being responsive to said monitoring module to prevent fluid flow through the conduit when said at least one variation in said corrected sensing signal is indicative of a malfunction.