Systems and methods with interrupt/resume capabilities for treating subcutaneous lipid-rich cells

• US 8,603,073 B2
• Filed: 12/17/2008
• Issued: 12/10/2013
• Est. Priority Date: 12/17/2008
• Status: Active Grant

• Current Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Original Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Inventors: Allison, John W.
• Primary Examiner(s): Stigell, Theodore J
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/337,544
• Publication Number:
  US 20100152824A1
• Time in Patent Office: 1,819 Days
• Field of Search: 604/542, 604/291, 606 20- 26, 607 96- 99
• US Class Current: 604/542
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/029 Fat cell removal or destruction by non-ablative heat treatment
• CPC Class Codes: A61F 2007/0296 Intervals of heating alternated with intervals of cooling
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags

Abstract

Systems for removing heat from a subject'"'"'s subcutaneous lipid-rich regions, such as tissue, organs, cells, and so forth, are described herein. In various embodiments, the system includes a treatment device and a controller for controlling a treatment process. The controller is configured to detect and compensate for an interruption in the treatment process.

Claims

1. A system for treating a subcutaneous lipid-rich region of a subject, comprising:

a treatment device having a cooling plate configured to remove heat from the subcutaneous lipid-rich region of the subject during a treatment process; and

a controller in electrical communication with the treatment device, the controller having a computer-readable medium containing instructions for performing a process comprising;

performing a treatment process of the subcutaneous lipid-rich region with the treatment device to cool the subcutaneous lipid-rich region;

detecting an interruption while the treatment device operates to cool the subcutaneous lipid-rich region during the treatment process;

performing a recovery process in response to the detected interruption;

returning the subcutaneous lipid-rich region of the subject to a condition generally similar to that at a time of the detected interruption; and

continuing the treatment process to cool the subcutaneous lipid-rich region after performing the recovery process.

2. The system of claim 1 wherein the instructions for performing a recovery process further include instructions for performing a process comprising:

determining an elapsed time of the treatment process;

deriving an interrupt temperature (T_interrupt) of the subcutaneous lipid-rich region based on the elapsed time of the treatment process;

determining an elapsed time of the interruption;

deriving a rewarming temperature (T_rewarm) of the subcutaneous lipid-rich region based on the elapsed time of the interruption;

calculating a cooling rate ({dot over (Q)}) for the recovery process as follows;

3. The system of claim 1 wherein the instructions for performing a recovery process further include instructions for performing a process comprising:

determining an interrupt temperature (T_interrupt) of the subcutaneous lipid-rich region when the treatment process is interrupted;

determining a rewarming temperature (T_rewarm) of the subcutaneous lipid-rich region based on an elapsed time since the interruption;

calculating a cooling rate ({dot over (Q)}) for the recovery process as follows;

4. The system of claim 1 wherein the instructions for performing a recovery process further include instructions for performing a process comprising:

determining whether the treatment process is resumable;

if the treatment process is resumable, performing the recovery process in response to the detected interruption; and

if the treatment process is not resumable, initiating a new treatment process.

14. The system of claim 1 wherein the interruption is at least one of detaching of the treatment device from the subject and freezing of adipose tissue of the subject.

5. A controller useful for treating a subcutaneous lipid-rich region of a subject, the controller having a computer-readable medium containing instructions for performing a process comprising:

activating a cooling plate to remove heat from the subcutaneous lipid-rich region during a treatment process; and

when the treatment process is interrupted while the cooling plate operates to cool the subcutaneous lipid-rich region, determining a profile for a recovery process to compensate for rewarming of the subcutaneous lipid-rich region of the subject during the interruption.

6. The controller of claim 5 wherein the profile for the recovery process includes at least one of an average cooling rate, a recovery duration, and an expected rate of change for a temperature at an interface between the subject and the cooling plate.

7. The controller of claim 5 wherein the profile for the recovery process includes an average cooling rate ({dot over (Q)}) and a recovery duration (π

) related to each other as follows;

8. The controller of claim 5 wherein the profile for the recovery process includes an expected rate of change for a temperature at an interface between the subject and the cooling plate calculated as follows:

9. The controller of claim 5 wherein the process further includes:

detecting the interruption in the treatment process;

determining whether the treatment process is resumable; and

if the treatment process is resumable, performing the recovery process according to the determined profile and subsequently continuing the treatment process.

10. The controller of claim 5 wherein the profile for the recovery process includes an expected rate of change for a temperature at an interface between the subject and the cooling plate, and wherein the process further includes:

detecting the interruption in the treatment process;

determining whether the treatment process is resumable;

if the treatment process is resumable, and

performing the recovery process according to the determined profile;

monitoring the rate of change; and

adjusting the profile for the recovery process if the monitored rate of change deviates from the expected rate of change by a preselected amount.

11. The controller of claim 5 wherein the profile for the recovery process includes at least one of an average cooling rate, a recovery duration, and an expected rate of change for a temperature at an interface between the subject and the cooling plate, and wherein the process further includes:

detecting the interruption in the treatment process;

determining whether the treatment process is resumable; and

if the treatment process is resumable,

performing the recovery process according to the determined profile;

monitoring the rate of change for the temperature at the interface between the subject and the cooling plate; and

if the monitored rate of change deviates from the expected rate of change by a preselected amount, performing at least one of increasing a power level to the heat exchanging device and increasing the recovery duration.

12. The controller of claim 5 wherein the process further includes determining an interruption temperature of the subcutaneous lipid-rich region at the time of the interruption and a rewarming temperature of the subcutaneous lipid-rich region after the interruption based on an elapsed time of the treatment process and an elapsed time of the interruption, respectively.

13. The controller of claim 5 wherein the process further includes a database containing lookup tables of temperatures of the subcutaneous lipid-rich region and corresponding cooling and/or rewarming durations, and wherein the process further includes determining an interruption temperature of the subcutaneous lipid-rich region at the time of the interruption and a rewarming temperature of the subcutaneous lipid-rich region after the interruption based on the lookup tables in the database and an elapsed time of the treatment process and an elapsed time of the interruption, respectively.

15. A system for treating a subcutaneous lipid-rich region of a subject, comprising:

a treatment device configured to remove heat from the subcutaneous lipid-rich region of the subject during a treatment process; and

a controller in communication with the treatment device and containing instructions for;

starting a treatment process by removing heat from the subcutaneous lipid-rich region using the treatment device such that the subcutaneous lipid-rich region is substantially maintained within a treatment temperature range at which lipid rich cells in the subcutaneous lipid-rich region are affected;

detecting an interruption of the treatment process before completion of the treatment process;

performing a recovery process in response to the detected interruption, the recovery process including cooling the subcutaneous lipid-rich region to return the subcutaneous lipid-rich region to the treatment temperature range; and

resuming the treatment process after performing the recovery process by substantially maintaining the subcutaneous lipid-rich region within the treatment temperature range to affect lipid rich cells in the subcutaneous lipid-rich region.

16. The system of claim 15 wherein performing the recovery process includes compensating for warming of the subcutaneous lipid-rich region of the subject after the interruption and before resuming the treatment process.

17. The system of claim 15 wherein the treatment temperature range is about −

20°

C. to about 20°

C.

18. The system of claim 15 wherein performing the recovery process includes determining a profile for operating the treatment device to compensate for warming of the subcutaneous lipid-rich region of the subject to return the subcutaneous lipid-rich region to the treatment temperature range.

19. A system for treating a subcutaneous lipid-rich region of a subject, comprising:

a treatment device configured to cool the subcutaneous lipid-rich region of the subject; and

a controller in communication with the treatment device and containing instructions for;

starting a treatment process by cooling the subcutaneous lipid-rich region using the treatment device such that the subcutaneous lipid-rich region is at a therapeutically effective cooled state;

detecting an interruption of heat transfer between the treatment device and the subject before completion of the treatment process;

after detecting the interruption, cooling the subcutaneous lipid-rich region such that the subcutaneous lipid-rich region is returned to the therapeutically effective cooled state; and

after returning the subcutaneous lipid-rich region to the therapeutically effective cooled state, continuing the treatment process to substantially maintain the subcutaneous lipid-rich region at the therapeutically effective cooled state to complete the treatment process.

20. The system of claim 19 wherein continuing the treatment process to substantially maintain the subcutaneous lipid-rich region at the therapeutically effective cooled state includes maintaining the subcutaneous lipid-rich region within a temperature range of about −

20°

C. to about 20°

C.

21. The system of claim 19 wherein controller further contains instructions for:

determining whether the treatment process is resumable based on the detected interruption;

if the treatment process is resumable, cooling the subcutaneous lipid-rich region to perform an uncompleted portion of the treatment process; and

if the treatment process is not resumable, initiating a new protocol to complete the treatment process.