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EP-4734867-A1 - DEVICE FOR PERCUTANEOUS CRYOLIPOLYSIS, KIT FOR PERCUTANEOUS CRYOLIPOLYSIS AND USE OF SUCH A DEVICE OR KIT FOR PERCUTANEOUS CRYOLIPOLYSIS

EP4734867A1EP 4734867 A1EP4734867 A1EP 4734867A1EP-4734867-A1

Abstract

The present invention relates to a device for percutaneous cryolipolysis, to a kit for percutaneous cryolipolysis and to the use of such a device or kit for percutaneous cryolipolysis, wherein the device comprises a main body, to which a cryo fluid source is couplable, and a cryo needle assembly (11), being coupled or couplable to the main body, wherein the cryo needle assembly (11) comprises at least one cryo needle (12). The at least one cryo needle (12) is configured to penetrate the skin (D1, D2) of a human or an animal at least partially. The device is configured to cause a cooling of at least one cryo needle (12) at least in a cryo needle cooling area (P1), when a cryo fluid source and the cryo needle assembly (11) are coupled to the main body, by using cryo fluid (G) from the cryo fluid source, and to form a subcutaneous (F) tissue cooling zone (CZ) adjacent to the cryo needle cooling area (P1) of the cooled cryo needle (12), when the cooled cryo needle (12) is penetrating the skin (D1, D2) of a human or an animal at least partially, wherein the device is configured to cool subcutaneous (F) fat cells (A, A1, A2) located in the tissue cooling zone (CZ) such that at least for some of the fat cells (A, A1, A2) located in the tissue cooling zone (CZ) apoptosis (A1) and/or necrosis (A2) is initiated.

Inventors

  • WINTER, Carolin

Assignees

  • Merz Aesthetics GmbH

Dates

Publication Date
20260506
Application Date
20240625

Claims (15)

  1. 1 . A device (10, 10A, 10B, 10C) for percutaneous cryolipolysis, comprising: a main body (13), to which a cryo fluid source (15, 24) is couplable, and a cryo needle assembly (11 ), being coupled or couplable to the main body (13), wherein the cryo needle assembly (11) comprises at least one cryo needle (12), wherein at least one cryo needle (12) is configured to penetrate the skin (D1 , D2) of a human or an animal at least partially, wherein the device (10, 10A, 10B, 10C) is configured, - to cause a cooling of at least one cryo needle (12) at least in a cryo needle cooling area (P1 ), when a cryo fluid source (15, 24) and the cryo needle assembly (11) are coupled to the main body (13), by using cryo fluid (G) from the cryo fluid source (15, 24), and - to form a subcutaneous tissue cooling zone (CZ) adjacent to the cryo needle cooling area (P1) of the cooled cryo needle (12), when the cooled cryo needle (12) is penetrating the skin (D1 , D2) of a human or an animal at least partially, and wherein the device (10, 10A, 10B, 10C) is configured to cool subcutaneous fat cells (A, A1 , A2) located in the tissue cooling zone (CZ) such that at least for some of the fat cells (A, A1 , A2) located in the tissue cooling zone (CZ) apoptosis (A1) and/or necrosis (A2) is initiated.
  2. 2. The device (10, 10A, 10B, 10C) according to claim 1 , wherein the device (10, 10A, 10B, 10C) is configured to cool the at least one cryo needle (12) in the cryo needle cooling area (P1) such that for at least 5 Vol.-%, 10 Vol.-%, 15 Vol.-%, 20 Vol.-%, 25 VoL-%,30 Vol.-%, 35 Vol.-%, 40 Vol.-%, 45 VoL-%, 50 VoL-%, 55 VoL-%, 60 Vol.-%, 65 Vol.-%, 70 VoL-%, 75 VoL-%, 80 VoL-%, 85 Vol.-%, 90 Vol.-% or 95 VoL-% of the fat cells (A, A1 , A2) located in the tissue cooling zone (CZ) apoptosis (A1) is initiated.
  3. 3. The device (10, 10A, 10B, 10C) according to claim 1 , wherein the device (10, 10A, 10B, 10C) is configured to cool the at least one cryo needle (12) in the cryo needle cooling area (P1) such that for at least 5 Vol.-%, 10 Vol.-%, 15 Vol.-%, 20 Vol.-%, 25 VoL-%,30 Vol.-%, 35 Vol.-%, 40 Vol.-%, 45 VoL-%, 50 VoL-%, 55 VoL-%, 60 Vol.-%, 65 Vol.-%, 70 Vol.-%, 75 VoL-%, 80 VoL-%, 85 Vol.-%, 90 Vol.-% or 95 VoL-% of the fat cells (A, A1 , A2) located in the tissue cooling zone (CZ) necrosis (A2) is initiated.
  4. 4. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 3, wherein the device (10, 10A, 10B, 10C) is configured to cool the at least one cryo needle (12) in the cryo needle cooling area (P1) such that for some fat cells located in the tissue cooling zone (CZ) apoptosis (A1 ) is initiated and for some fat cells (A, A1 , A2) located in the tissue cooling zone (CZ) necrosis (A2) is initiated, wherein in particular the ratio (A1 :A2) of the volume of fat cells (A, A1 , A2) located in the tissue cooling zone (CZ) for which apoptosis (A1 ) is initiated to the volume of fat cells (A, A1 , A2) located in the tissue cooling zone for which necrosis (A2) is initiated is in a range from 0.0, 0.1 , 0.2, 0.3, 0.4, 0.5, 0.6, 0.7. 0.8 or 0.9 to 1 .0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2 or 0.1.
  5. 5. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 4, wherein the device (10, 10A, 10B, 10C) is configured to cool the at least one cryo needle (12) in the cryo needle cooling area (P1 ) such that in the formed tissue cooling zone (CZ) the subcutaneous tissue (F) is cold down at least to +10°C, +5°C, +4°C, +3°C, +2°C, +1 ° or 0°C, but not cold down below -50°C, -40°C, -30°C, -20°C, -10°C, -9°C, -8°C, -7°C, -6°C, -5°C, -4°C, -3°C, -2°C or -1°C, wherein the subcutaneous tissue (F) in the tissue cooling zone (CZ) is preferably cold down to a tissue temperature (T1 , T2, T3) in a range from -50°C to +10°C, -40°C to +5°C, -30°C to 0°C or -20°C to -5°C.
  6. 6. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 5, wherein at least one cryo needle (12) comprises a thermal isolation (22) and/or comprises a thermal isolation material (22) or is at least partly made of a thermal isolating material (22).
  7. 7. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 6, wherein the device (10, 10A, 10B, 10C) comprises a valve to control, in particular to limit, a cooling flow (G) of the cryo fluid into and/or through at least one cryo needle (12).
  8. 8. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 7, wherein the device (10, 10A, 10B, 10C) is a handheld device (10, 10A, 10B, 10C).
  9. 9. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 8, wherein the main body (13) is couplable to a stationary cryo fluid storage (15) as cryo fluid source (15), preferably of CO2 or N2 or N2O or a combination thereof, in particular via at least one supply line (14).
  10. 10. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 9, wherein the cryo needle assembly (11) is interchangeable and detachably coupled or couplable to the main body (13), wherein in particular the main body (13) and/or the cryo needle assembly (11 ) comprises an adapter (19) via which the cryo needle assembly (11) and the main body (13) are coupled or couplable to each other.
  11. 11. The device (10, 10A, 10B, 10C) according to any one of the preceding claims, wherein at least one cryo needle (12) is a 15G, 16G, 17G, 18G, 19G, 20G, 21 G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31 G, 32G, 33G, 34G or 35G needle or cannula.
  12. 12. The device (10, 10A, 10B, 10C) according to any one of the preceding claims, wherein the needle assembly (11 ) comprises at least two cryo needles (12), in particular a group of needles (12), in particular an array of cryo needles (12), and/or wherein the needle assembly (11 ) comprises at least one micro needle, in particular at least one micro needle array.
  13. 13. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 12, wherein the device comprises a control unit (16) configured for controlling the cooling of the cryo needle cooling area (P1 ), in particular for controlling of a cooling temperature in the cryo needle cooling area (P1 ), to control the cooling temperature (T1 , T2, T3) in the tissue cooling zone (CZ).
  14. 14. A kit (100) for percutaneous cryolipolysis, comprising: a device (10, 10A, 10B, 10C), comprising: a main body (13), to which a cryo fluid source (15, 24) is couplable, and a cryo needle assembly (11 ), being coupled or couplable to the main body (13), wherein the cryo needle assembly (11) comprises at least one cryo needle (12), wherein at least one cryo needle (12) is configured to penetrate the skin (D1 , D2) of a human or an animal at least partially, wherein the device (10, 10A, 10B, 10C) is configured, - to cause a cooling of at least one cryo needle (12) at least in a cryo needle cooling area (P1 ), when a cryo fluid source (15, 24) and the cryo needle assembly (11 ) are coupled to the main body (13), by using cryo fluid (G) from the cryo fluid source (15, 24), and - to form a subcutaneous tissue cooling zone (CZ) adjacent to the cryo needle cooling area (P1 ) of the cooled cryo needle (12), when the cooled cryo needle (12) is penetrating the skin (D1 , D2) of a human or an animal at least partially, and wherein the device (10, 10A, 10B, 10C) is configured to cool subcutaneous fat cells (A) located in the tissue cooling zone (CZ) such that at least for some of the fat cells (A, A1 , A2) located in the tissue cooling zone (CZ) apoptosis (A1 ) and/or necrosis (A2) is initiated, and a cryo fluid source (15, 24).
  15. 15. Use of a device (10, 10A, 10B, 10C) configured for percutaneous cryolipolysis or a kit (100) configured for percutaneous cryolipolysis for cosmetic, aesthetic or therapeutic application, particularly for percutaneous cryolipolysis, the device (10, 10A, 10B, 10C) for percutaneous cryolipolysis comprising: a main body (13), to which a cryo fluid source (13, 24) is couplable, and a cryo needle assembly (11 ), being coupled or couplable to the main body (13), wherein the cryo needle assembly (11) comprises at least one cryo needle (12), wherein at least one cryo needle (12) is configured to penetrate the skin (D1 , D2) of a human or an animal at least partially, wherein the device (10, 10A, 10B, 10C) is configured, - to cause a cooling of at least one cryo needle (12) at least in a cryo needle cooling area (P1 ), when a cryo fluid source (15, 24) and the cryo needle assembly (11) are coupled to the main body (13), by using cryo fluid (G) from the cryo fluid source (15, 24), and - to form a subcutaneous (F) tissue cooling zone (CZ) adjacent to the cryo needle cooling area (P1 ) of the cooled cryo needle (12), when the cooled cryo needle (12) is penetrating the skin (D1 , D2) of a human or an animal at least partially, and wherein the device (10, 10A, 10B, 10C) is configured to cool subcutaneous (F) fat cells (A) located in the tissue cooling zone (CZ) such that at least for some of the fat cells (A, A1 , A2) located in the tissue cooling zone (CZ) apoptosis (A1) and/or necrosis (A2) is initiated.

Description

DEVICE FOR PERCUTANEOUS CRYOLIPOLYSIS, KIT FOR PERCUTANEOUS CRYOLIPOLYSIS AND USE OF SUCH A DEVICE OR KIT FOR PERCUTANEOUS CRYOLIPOLYSIS FIELD OF THE INVENTION The present invention relates to a device for percutaneous cryolipolysis, wherein the device comprises a main body, to which a cryo fluid source is couplable, and a cryo needle assembly, being coupled or couplable to the main body, wherein the cryo needle assembly comprises at least one cryo needle. At least one cryo needle is configured to penetrate the skin of a human or an animal at least partially. The device is configured to cause a cooling of at least one cryo needle at least in a cryo needle cooling area, when a cryo fluid source and the cryo needle assembly are coupled to the main body, by using cryo fluid from the cryo fluid source, and the device is configured to form a subcutaneous tissue cooling zone adjacent to the cryo needle cooling area of the cooled cryo needle, when the cooled cryo needle is penetrating the skin of a human or an animal at least partially. The present invention further relates to a kit for percutaneous cryolipolysis, comprising a device for percutaneous cryolipolysis and a cryo fluid source. In addition, the present invention relates to the use of a device for percutaneous cryolipolysis or a kit for percutaneous cryolipolysis for cosmetic, aesthetic or therapeutic application, particularly for percutaneous cryolipolysis for cosmetic, aesthetic or therapeutic purpose. BACKGROUND OF THE INVENTION Sometimes treatment of body tissue, in particular destruction and/or removal of body tissue like tumor tissue or fat tissue, is wanted or necessary, from a health perspective or for other reasons, for example for cosmetic and/or aesthetic reasons. One established therapy for the treatment of tumor tissue, in particular for destruction and/or removal of tumor tissue, for example, is so-called “cryosurgery”, in particular cryoablation of tumor tissue, which is based on application of extreme cold to the tumor tissue to be treated. Several methods and devices are known therefore. WO 2019/213205 A1 , for example, discloses a handheld cryoprobe for use in invasive, percutaneous cryotherapy of tumorous masses. The handheld cryoprobe includes a probe attached to a CO2 gas dispensing backend. The probe has specifically optimized parameters designed for use with CO2 gas and is made out of a partially hollowed and threaded aluminium rod providing maximum heat exchange. The system backend regulates flow of compressed CO2 gas while throttling and cooling the gas coolant to the cytotoxically low temperatures necessary for targeted tumour cell death. Additionally, the incoming initial stream of CO2 gas is throttled by the Joule-Thomson nozzle on the backend. The low temperature exhaust gas is then used to pre-cool all subsequent incoming gas, resulting in an even lower temperature at the probe tip, which provides a positive feedback loop, continually decreasing the gas's temperature. The temperature drop is caused by the Joule-Thomson effect. From US 2021/244457 A1 , an apparatus for invasive treatment of a breast, a prostate or a kidney tumour is known, consisting of a probe, containing a lumen and having a distal end configured to contact tissue of a living subject. A temperature sensor is located at the distal end, and a pump, having a pump motor, is coupled to deliver a cryogenic fluid through the lumen to the distal end of the probe and to receive the cryogenic fluid returning from the probe. There is a separator, coupled to separate the returning cryogenic fluid into a returning cryogenic liquid and a returning cryogenic gas, and a flow meter, coupled to measure a rate of flow of the returning cryogenic gas. A processor is configured to control a rate of pumping of the pump motor in response to a temperature measured by the temperature sensor and the rate of flow of the returning cryogenic gas. The company “IceCure” provides with “ProSense™” a cryoablation device for treatment of tumorous tissue of several cancer types, in particular for treatment of breast cancer and prostate, lung and bone cancer, which uses liquid nitrogen for cooling, see for example https://icecure-medical.com/ and https://youtu.be/TfhQJ3SN6wQ, last accessed on June 14, 2023. Boston Scientific also provides cryoablation devices for invasive treatment of tumour cells by applying extreme cold, wherein the tumour cells are cold down to -20°C to -40°C, see for example https://www.bostonscientific.com/en- US/products/cryoablation/icefx.html#, last accessed on June 14, 2023. Fat cells, which are different from tumour cells and have different properties and show different reactions on treatment, are often removed by liposuction, wherein fat cells are separated from the surrounding tissue and are suctioned off. However, liposuction is an invasive method and has a plurality of undesirable side effects. For improved liposuction, WO 98/41157 suggests combining cryosurge