Treatment systems with fluid mixing systems and fluid-cooled applicators and methods of using the same

• US 9,844,460 B2
• Filed: 03/14/2013
• Issued: 12/19/2017
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Original Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Inventors: Weber, Bryan J., Coakley, Joseph, Baker, Mark William, Reeve, III, Thomas Burnell
• Primary Examiner(s): Hupczey, Jr., Ronald
• Application Number:
  US13/830,027
• Publication Number:
  US 20140277302A1
• Time in Patent Office: 1,741 Days
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0093 programmed
• 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 2007/0295 for heating or cooling or use at more than one temperature
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids

Abstract

A treatment system for cooling subcutaneous lipid-rich cells in a human subject includes an applicator and a control unit. The treatment system has a cooling mode for cooling tissue and a heating mode for warming tissue. The control unit includes a circulation circuit in fluid communication with the applicator, a chiller apparatus configured to chill fluid from the applicator circulation circuit, and a heater apparatus to warmed fluid from the applicator circulation circuit. The control unit mixes the chilled fluid and/or the warmed with fluid in the applicator circulation circuit control the temperature of the fluid circulated in the applicator.

Claims

1. A treatment system for cooling subcutaneous lipid-rich cells in a subject, comprising:

an applicator configured to be in thermal communication with skin of the subject;

a control unit having a cooling state and a heating state, the control unit including

an applicator circulation circuit including a supply end in fluid communication with the applicator and a return end in fluid communication with the applicator, the applicator circulation circuit defining a flow path extending between the supply end and the return end and along which coolant flows to deliver coolant to the applicator,

a chiller apparatus configured to chill coolant from the applicator circulation circuit, the chiller apparatus is configured to deliver chilled coolant to the applicator circulation circuit to reduce a temperature of coolant in the applicator circulation circuit from room temperature to a temperature less than 0°

C. while chilled coolant in the chiller apparatus is maintained at a temperature less than 0°

C. when the control unit is in the cooling state, and

a heater apparatus configured to deliver heated coolant to the applicator circulation circuit to raise the temperature of the coolant in the applicator circulation circuit when the control unit is in the heating state;

a controller having instructions that, when executed, causes the chiller apparatus to deliver chilled coolant to the applicator circulation circuit such that the coolant cools the applicator enough to keep the subcutaneous lipid-rich cells at or below 0°

C. for a sufficient length of time to disrupt target subcutaneous lipid-rich cells; and

a mixing reservoir along the flow path and configured to hold a sufficient volume of the coolant for cooling the applicator such that the applicator cools target subcutaneous lipid-rich cells to a temperature lower than 0°

C.,

wherein the chiller apparatus includes a chilled reservoir configured to hold a sufficient volume of pre-chilled coolant for mixing with and cooling the coolant held in the mixing reservoir to a temperature lower than 0°

C.

2. The treatment system of claim 1 wherein the chiller apparatus includes a chiller fluidic circuit configured to hold a volume of chilled coolant and deliver chilled coolant to the applicator circulation circuit to reduce the temperature of coolant that is delivered to the applicator by at least about 20°

C. in less than about 5 minutes.

3. The treatment system of claim 1 wherein the chiller apparatus includes a chiller fluidic circuit that receives coolant from the applicator circulation circuit and delivers chilled coolant to the applicator circulation circuit while coolant flows continuously along the flow path of the applicator circulation circuit.

4. The treatment system of claim 1 wherein the chiller apparatus includes a cooling device, wherein the chilled reservoir receives coolant from the applicator circulation circuit, and the cooling device removes heat from coolant contained in the chilled reservoir.

5. The treatment system of claim 1 wherein the applicator circulation circuit defines a primary loop, a chiller fluidic circuit of the chiller apparatus defines a first secondary loop, and a heater fluidic circuit of the heater apparatus defines a second secondary loop.

6. The treatment system of claim 1 wherein the chiller apparatus and the heater apparatus are configured to independently deliver the chilled coolant and heated coolant, respectively, to the applicator circulation circuit.

7. The treatment system of claim 1, further comprising a passive fluid leveling element that delivers coolant from the applicator circulation circuit to the chiller apparatus.

8. The treatment system of claim 7 wherein the passive fluid leveling element allows coolant to flow from the applicator circulation circuit to the chiller apparatus when a volume of the coolant in the applicator circulation circuit is at or above a limit volume.

9. The treatment system of claim 7 wherein the passive fluid leveling element includes a spillway that allows coolant to flow from the mixing reservoir to the chiller apparatus.

10. The treatment system of claim 7 wherein the passive fluid leveling element includes a conduit with one end fluidically coupled to the mixing reservoir and another end fluidically coupled to the chilled reservoir.

11. The treatment system of claim 10 wherein the conduit allows a level of chilled coolant in the chilled reservoir to generally equilibrate with a level of coolant in the mixing reservoir.

12. The treatment system of claim 1 wherein the mixing reservoir is configured to accept chilled coolant from the chiller apparatus and warm coolant from the applicator, the appilcator circulation circuit including a return conduit fluidically coupling an outlet of the applicator to the mixing reservoir, and a delivery conduit fluidically coupling the mixing reservoir to an inlet of the applicator.

13. The treatment system of claim 1, wherein the controller is in communication with the chiller apparatus and the heater apparatus, the controller containing instructions that, when executed, causes the controller to:

command the chiller apparatus to deliver the chilled coolant to the applicator circulation circuit to lower a temperature of the coolant delivered to the applicator; and

command the heater apparatus to deliver the heated coolant to the applicator circulation circuit to raise a temperature of the coolant delivered to the applicator.

14. The treatment system of claim 1 wherein the chiller apparatus includes a cold pump operative to direct the chilled coolant into the applicator circulation circuit, and wherein the heater apparatus includes a warm pump operative to direct the heated coolant into the applicator circulation circuit.

15. The treatment system of claim 1 wherein the applicator has a heat exchanger element configured to transfer heat from the subcutaneous lipid-rich cells of the subject to coolant in the applicator to affect the subcutaneous lipid-rich cells.

16. The treatment system of claim 1, further comprising a temperature monitoring device communicatively coupled to the controller, the controller containing instructions for commanding the chiller apparatus to deliver chilled coolant the applicator circulation circuit based, at least in part, on one or more signals from the temperature monitoring device.

17. The treatment system of claim 1, further comprising a temperature monitoring device communicatively coupled to the controller, the controller contains containing instructions for commanding the heater apparatus to deliver heated coolant into the applicator circulation circuit based, at least in part, on one or more signals from the temperature monitoring device.

18. The treatment system of claim 1 wherein the heater apparatus includes a heat exchanger that heats coolant from the applicator circulation circuit by extracting heat from air.

19. The treatment system of claim 1 wherein the control unit is configured to deliver the coolant at a temperature lower than the subject'"'"'s skin temperature when the subject'"'"'s skin temperature is equal to or lower than about −

5°

C.

20. The treatment system of claim 1 wherein the applicator includes a heat exchanger element having a heat exchanging body and a tubular member positioned within the heat exchanging body such that coolant flowing through the tubular member absorbs the heat transferred from the subject to the heat exchanging body.

21. The treatment system of claim 1 wherein the control unit is configured to deliver the coolant, which is at a temperature lower than about −

5°

C., from the chiller apparatus to the applicator.

22. A treatment system for cooling subcutaneous lipid-rich cells in a subject, the treatment system comprising:

an applicator configured to be in thermal communication the subject'"'"'s skin;

a control unit having a cooling state and a heating state, the control unit including

an applicator circulation circuit including

a supply end in fluid communication with the applicator,

a return end in fluid communication with the applicator, and

a mixing reservoir positioned along a flow path of the applicator circulation circuit, the flow path extending between the supply end and the return end,

a chiller apparatus fluidically coupled to the applicator circulation circuit, the chiller apparatus including a chilled reservoir configured to hold a volume of pre-chilled coolant at a standby temperature that is lower than 0°

C.;

a controller in communication with the control unit and the chiller apparatus, the controller containing instructions that, when executed, causes the controller to;

command the chiller apparatus to deliver chilled coolant from the chilled reservoir to the mixing reservoir to lower a temperature of coolant contained in the mixing reservoir to a temperature lower than 0°

C., and

command the applicator circulation circuit to deliver the coolant cooled to a temperature lower than 0°

C. from the mixing reservoir to the applicator such that the applicator cools target subcutaneous lipid-rich cells of the subject to a temperature lower than 0°

C.; and

command the chiller apparatus to deliver chilled coolant to the applicator circulation circuit to cool the coolant in the applicator circulation circuit to keep the target subcutaneous lipid-rich cells at or below 0°

C. for a sufficient length of time to disrupt the target subcutaneous lipid-rich cells.

23. The treatment system of claim 22 wherein the controller contains instructions to cause the chiller apparatus to continuously or periodically deliver the chilled coolant to the mixing reservoir to keep coolant flowing through the applicator at a temperature lower than about −

5°

C.

24. The treatment system of claim 22 wherein the controller contains instructions that, when executed, cause the chiller apparatus to deliver the chilled coolant to the applicator circulation circuit to reduce the temperature of the coolant delivered to the applicator from room temperature to a temperature less than about 0°

C. while the chilled coolant in the chiller apparatus is maintained at a temperature lower than about 0°

C.

25. The treatment system of claim 22 wherein the mixing reservoir is configured to hold a volume of the chilled coolant having a thermal mass equal to or less than about 70% of a total mass of the applicator circulation circuit.

26. The treatment system of claim 22 wherein the control unit is configured to deliver the coolant, which is at a temperature lower than about −

5°

C., to the applicator.

27. The treatment system of claim 22, further comprising a temperature monitoring device, the controller being communicatively coupled to the temperature monitoring device and containing instructions for commanding the chiller apparatus to deliver chilled to coolant the applicator circulation circuit based, at least in part, on one or more signals from the temperature monitoring device so to disrupt the target subcutaneous lipid-rich cells.

28. A treatment system for cooling subcutaneous lipid-rich cells in a subject, the treatment system comprising:

an applicator configured to be in thermal communication the subject'"'"'s skin and including at least one temperature sensor,

a control unit having a cooling state and a heating state, the control unit including

an applicator circulation circuit including

a supply end in fluid communication with the applicator,

a return end in fluid communication with the applicator, and

a mixing reservoir positioned along a flow path of the applicator circulation circuit, the flow path extending between the supply end and the return end,

a chiller apparatus fluidically coupled to the applicator circulation circuit, the chiller apparatus including a chilled reservoir configured to hold a volume of pre-chilled coolant at a standby temperature that is lower than 0°

C.;

a controller in communication with the at least one temperature sensor and the chiller apparatus, the controller having instructions that, when executed, causes the controller to

command the chiller apparatus to deliver chilled coolant from the chilled reservoir to the mixing reservoir to lower a temperature of coolant contained in the mixing reservoir to a temperature lower than 0°

C., and

command the control unit based on a temperature measurement from the at least one temperature sensor to deliver the coolant, which is at a temperature lower than 0°

C., to the applicator such that the applicator cools target subcutaneous lipid-rich cells of the subject to a temperature lower than 0°

C. for a sufficient length of time to disrupt the target subcutaneous lipid-rich cells.

29. The treatment system of claim 28, wherein the applicator includes at least one heat exchanger element configured to cool the subject'"'"'s skin while the at least one temperature sensor provides temperature measurements.