SYSTEMS AND METHODS FOR MONITORING COOLING OF SKIN AND TISSUE TO IDENTIFY FREEZE EVENTS

• US 20160317346A1
• Filed: 04/27/2016
• Published: 11/03/2016
• Est. Priority Date: 04/28/2015
• Status: Active Application

• Current Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Original Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Inventors: Kovach, Dennis
• Application Number:
  US15/140,415
• Publication Number:
  US 20160317346A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2034/101 Computer-aided simulation of surgical operations
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7214 using signal cancellation, e.g. based on input of two identical physiological sensors spaced apart, or based on two signals derived from the same sensor, for different optical wavelengths
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61F 2007/0052 for treatment of skin or hair
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0087 Hand-held applicators
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0228 with belt or strap, e.g. with buckle
• CPC Class Codes: A61F 7/007 characterised by electric heating

Abstract

A system and method of detecting, evaluating, monitoring events during the removal of heat from tissue beneath skin. The system utilizes an adaptive filter to determine if a partial freeze event is occurring, and performs an action based on the determination. In some examples, the system shuts off the treatment device, alerts an operator, reduces the cooling, and/or limits an amount of further cooling, in response to a determined treatment event. The system further applies a plurality of algorithms to detected signals in parallel to arrive at a plurality of estimates of whether a freeze event is occurring and confidences associated with the estimates. The estimates are used to evaluate whether the freeze event is in fact occurring.

Claims

1. A non-invasive treatment system for removing heat from a subject'"'"'s subcutaneous tissue, the treatment system comprising:

a treatment device configured to contact an area of the subject'"'"'s skin and remove heat from the tissue located below the contacted area of skin;

a first sensor that measures a characteristic of at least one of the treatment device, the tissue, and the skin, the sensor being configured to output a first signal;

a signal processor programmed to estimate a noise characteristic of the first signal and based on the estimated noise characteristic to adaptively filter the first signal to provide at least one filtered first signal, wherein the signal processor is programmed to use the filtered first signal to determine whether at least a partial freeze event has occurred; and

a controlling device that modifies operation of the treatment device upon the determination of the at least partial freeze event.

2. The treatment system of claim 1, wherein the signal processor is programmed to dynamically change its transfer function to adapt and remove varying amounts of noise from the first signal based on the estimated noise characteristic.

3. The treatment system of claim 1, wherein the signal processor includes an adaptive low pass filter, a Kalman filter, and/or an adaptive noise canceller.

4. The treatment system of claim 1, wherein the signal processor includes an adaptive low pass filter which averages the first signal, wherein an amount of averaging is dependent on the estimated noise characteristic.

5. The treatment system of claim 1, wherein the signal processor includes a Kalman filter, wherein the Kalman filter:

generates a plurality of measurements derived from the first signal;

compares selected measurements with at least one expected measurement characteristic;

assigns one of a plurality of variable weights to each selected measurement based on the comparing step, thereby generating a plurality of weighted measurements;

assigns the plurality of variable weights in part, in response to a similarity between each selected measurement and a corresponding previous measurement;

averages the plurality of weighted measurements to obtain a filtered measurement for use in estimating a likelihood of the partial freeze event; and

selectively adjusts at least one step in the averaging and assigning steps, the adjusting step based on knowledge, which is derived independently of the plurality of measurements in the generating step, of at least one characteristic of the treatment device, tissue, or skin.

6. The treatment system of claim 1, further comprising a second sensor which measures a second signal, wherein the signal processor includes an adaptive noise canceller that combines the first and second signals to create the filtered first signal.

7. The treatment system of claim 6, wherein the second sensor is a mechanical sensor, an optical sensor, and/or an impedance sensor.

8. The treatment system of claim 1, wherein the modified operation is selected from the group (a) turning off a cooling capability of the treatment device, (b) reducing but not turning off a cooling capability of the treatment device, (c) adjusting a treatment time of the treatment device, and/or (d) alerting a clinician.

9. The treatment system of claim 1, wherein the signal processor is programmed to determine that the freeze event has occurred by (a) determining when a characteristic of the filtered first signal exceeds a first predetermined value and (b) determining that the first predetermined value is exceeded by a first period of time.

10. The treatment system of claim 1, wherein the first predetermined value and the first period of time are variable and dependent on the estimated noise characteristic.

11. The treatment system of claim 1, wherein the sensor outputs the first signal at a frequency in excess of either 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 Hz.

12. A non-invasive treatment system for transdermally removing heat from tissue beneath a subject'"'"'s skin, the treatment system comprising:

a treatment device configured to contact an area of the skin and remove heat from the tissue located below the contacted area of skin;

a first sensor that measures a characteristic of at least one of the treatment device, the tissue, and the skin, wherein the sensor is configured to output a first signal; and

a signal processor programmed to estimate a noise characteristic of the first signal and determine whether at least a partial freeze event has occurred, the determination being based in part on the estimated noise characteristic such that a partial freeze event is determined to not have occurred when the estimated noise characteristic exceeds a predetermined noise characteristic value.

13. The treatment system of claim 12, wherein the estimated noise characteristic is derived in part by comparing the first signal to at least one reference signal template.

14. A method for removing heat from tissue beneath skin and detecting a freeze event in the presence of motion, the method comprising:

a. removing heat from tissue located below a skin surface using a treatment device;

b. measuring a characteristic of at least one of the treatment device, the tissue, and the skin using a sensor, the sensor outputting a first signal;

c. adaptively filtering the first signal to create a filtered signal to eliminate motion artifact and read through motion induced signal noise; and

d. determining whether a freeze event is or has occurred based on analysis of the filtered signal.

15. A non-invasive treatment system for transdermally removing heat from tissue beneath a subject'"'"'s skin, the treatment system comprising:

a treatment device configured to contact an area of the skin and remove heat from the tissue located below the contacted area of skin;

a sensor that measures a characteristic of at least one of the treatment device, the tissue, and the skin, the sensor configured to output a signal; and

a controlling device that receives the signal and modifies operation of the treatment device upon determining at least a partial freeze event has occurred, the controlling device including a signal processor programmed to;

determine a first likelihood of the freeze event occurring using a first filtering algorithm on the output signal,

determine a second likelihood of the freeze event occurring using a second filtering algorithm on the output signal, and

determine whether the freeze event is occurring based on the first and second likelihoods.

16. The treatment system of claim 15, wherein at least one of the first and second filtering algorithms is used to adaptively filter the signal such that the signal processor dynamically changes its transfer function to adapt to and remove varying amounts of noise from the signal.

17. The treatment system of claim 15, wherein at least one of the first and second filtering algorithms measures a quality of the signal.

18. The treatment system of claim 15, wherein the freeze event includes at least partial freezing of the subject'"'"'s skin.