Search

RU-2025131968-A - PERCUTANEOUS CRYOLIPOLYSIS DEVICE, PERCUTANEOUS CRYOLIPOLYSIS KIT AND THE USE OF SUCH PERCUTANEOUS CRYOLIPOLYSIS DEVICE OR KIT

RU2025131968ARU 2025131968 ARU2025131968 ARU 2025131968ARU-2025131968-A

Inventors

  • ВИНТЕР, Кэролин

Assignees

  • МЕРЦ ЭСТЕТИКС ГМБХ

Dates

Publication Date
20260504
Application Date
20240625
Priority Date
20230630

Claims (20)

  1. 1. A device (10, 10A, 10B, 10C) for percutaneous cryolipolysis, comprising:
  2. - a main body (13), to which the possibility of connecting a source (15, 24) of a cryogenic fluid is provided, and
  3. - a cryoneedle unit (11) connected or configured to be connected to the main body (13), wherein the cryoneedle unit (11) comprises at least one cryoneedle (12),
  4. wherein at least one cryoneedle (12) is designed with the possibility of penetrating the skin (D1, D2) of a human or animal at least partially,
  5. wherein the device (10, 10A, 10B, 10C) is configured to
  6. - cause cooling of at least one cryoneedle (12) at least in the cryoneedle cooling region (P1), when the cryogenic fluid source (15, 24) and the cryogenic fluid assembly (11) are connected to the main body (13) by using the cryogenic fluid (G) from the cryogenic fluid source (15, 24), and
  7. - formation of a cooling zone (CZ) of the subcutaneous tissue adjacent to the cooling region (P1) of the cryoneedle of the cooled cryoneedle (12), when the cooled cryoneedle (12) at least partially penetrates the skin (D1, D2) of a human or animal, and
  8. wherein the device (10, 10A, 10B, 10C) is configured to cool the subcutaneous fat cells (A, A1, A2) located in the tissue cooling zone (CZ), such that apoptosis (A1) and/or necrosis (A2) is initiated for at least some of the fat cells (A, A1, A2) located in the tissue cooling zone (A1).
  9. 2. The device (10, 10A, 10B, 10C) according to claim 1, in which the device (10, 10A, 10B, 10C) is configured to cool at least one cryoneedle (12) in the cryoneedle cooling region (P1) such that apoptosis (A1) is initiated in 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 tissue cooling zone (CZ).
  10. 3. The device (10, 10A, 10B, 10C) according to claim 1, in which the device (10, 10A, 10B, 10C) is configured to cool at least one cryoneedle (12) in the cryoneedle cooling region (P1) in such a way that necrosis (A2) is initiated in 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 zone (CZ) tissue cooling.
  11. 4. The device (10, 10A, 10B, 10C) according to any one of claims 1-3, in which the device (10, 10A, 10B, 10C) is configured to cool at least one cryoneedle (12) in the cryoneedle cooling region (P1) in such a way that apoptosis (A1) is initiated for some fat cells located in the tissue cooling zone (CZ), and necrosis (A2) is initiated for some fat cells (A, A1, A2) located in the tissue cooling zone (CZ), 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 the range of 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.
  12. 5. The device (10, 10A, 10B, 10C) according to any one of claims 1-4, in which the device (10, 10A, 10B, 10C) is configured to cool at least one cryoneedle (12) in the cryoneedle cooling zone (P1) in such a way that in the formed tissue cooling zone (CZ), the subcutaneous tissue (F) is cooled to at least +10°C, +5°C, +4°C, +3°C, +2°C, +1(or 0°C, but is not cooled 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 cooled to a tissue temperature (T1, T2, T3) in the range from -50°C to +10°C, from -40°C to +5°C, from -30°C to 0°C or from -20°C to -5°C.
  13. 6. The device (10, 10A, 10B, 10C) according to any one of claims 1-5, in which at least one cryoneedle (12) comprises thermal insulation (22) and/or comprises thermal insulation material (22) or is at least partially made of thermal insulation material (22).
  14. 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 for controlling, in particular for limiting, the cooling flow (G) of the cryogenic fluid into and/or through at least one cryoneedle (12).
  15. 8. The device (10, 10A, 10B, 10C) according to any one of claims 1-7, in which the device (10, 10A, 10B, 10C) is a hand-held device (10, 10A, 10B, 10C).
  16. 9. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 8, in which the main body (13) is configured to be connected to a stationary storage (15) of a cryogenic fluid as a source (15) of a cryogenic fluid, preferably CO 2 , or N 2 , or N 2 O, or a combination thereof, in particular via at least one supply line (14).
  17. 10. The device (10, 10A, 10B, 10C) according to any one of claims 1 to 9, wherein the cryoneedle assembly (11) is interchangeable and is releasably connected or configured to be connected to the main body (13), wherein, in particular, the main body (13) and/or the cryoneedle assembly (11) comprises an adapter (19) by means of which the cryoneedle assembly (11) and the main body (13) are connected or configured to be connected to each other.
  18. 11. The device (10, 10A, 10B, 10C) according to any of the preceding claims, in which at least one cryoneedle (12) is a 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G or 35G needle or cannula.
  19. 12. A device (10, 10A, 10B, 10C) according to any one of the preceding claims, wherein the needle assembly (11) comprises at least two cryoneedles (12), in particular a group of needles (12), in particular an array of cryoneedles (12), and/or wherein the needle assembly (11) comprises at least one microneedle, in particular at least one array of microneedles.
  20. 13. The device (10, 10A, 10B, 10C) according to any one of claims 1-12, wherein the device comprises a control unit (16) configured to control the cooling of the cryoneedle cooling region (P1), in particular to control the cooling temperature in the cryoneedle cooling region (P1), to control the cooling temperature (T1, T2, T3) in the tissue cooling zone (CZ).