阅读说明：本技术 皮下脂肪治疗的方法和装置 (Method and apparatus for subcutaneous fat therapy ) 是由 Y·齐默尔曼 于 2018-05-01 设计创作，主要内容包括：本文公开了适用于透皮杀死受试者的皮下脂肪层中的脂肪细胞的方法和装置。(Disclosed herein are methods and devices suitable for transdermally killing adipocytes in a subcutaneous fat layer of a subject.)

1. A non-surgical, non-invasive cosmetic method of altering the aesthetic appearance of a portion of the human body by killing subcutaneous fat cells, the method comprising:

a. irradiating light through a portion of the epidermis of a subject, transdermally heating a portion of the subcutaneous fat layer of the subject using incoherent multiple light sources, the irradiating light having a cross-sectional area at the surface of the epidermis of a thickness sufficient in size to be greater than the thickness of the skin thickness, the heating sufficient to kill and/or induce apoptosis of at least some adipocytes in the portion of the subcutaneous fat layer; and

b. cooling the portion of the epidermis sufficiently to prevent burning of the epidermis while the transdermal heating,

wherein the irradiation light is substantially composed of light having a wavelength in a near infrared range of not less than 850nm and not more than 1100nm,

thereby destroying adipocytes in the portion of the subcutaneous fat layer.

2. A method of altering the appearance of a portion of a human body by killing subcutaneous fat cells, the method comprising:

a. transdermally heating a portion of a subcutaneous fat layer of a subject using incoherent multiple light sources illuminating light through a portion of an epidermis of the subject, the illuminating light having a cross-sectional area at a surface of the epidermis of a thickness sufficient in size to be greater than a thickness of a skin thickness, the heating sufficient to kill at least some adipocytes in the portion of the subcutaneous fat layer; and

b. cooling the portion of the epidermis sufficiently to prevent burning of the epidermis while the transdermal heating,

wherein the irradiation light is substantially composed of light having a wavelength in a near infrared range of not less than 850nm and not more than 1100nm,

thereby destroying adipocytes in the portion of the subcutaneous fat layer.

3. The method of any of claims 1-2, wherein a total power density of the illumination light at the wavelengths within the range is not less than 0.3W/cm²And not more than 5W/cm²。

4. The method of any one of claims 1 to 3, wherein each or some of the multiple light sources operate independently and the illumination can be arranged with different light source pulses having different duty cycles to create different light distributions on tissue and relieve pain.

5. The method of any one of claims 1 to 3, wherein said transdermal heating of said subcutaneous fat layer of said subject is carried out for at least one course of treatment, wherein each volume of subcutaneous fat layer treated is continuously transdermal heated for a duration of at least 10 minutes.

6. A device suitable for transdermally killing adipocytes in a subcutaneous fat layer of a subject, the device comprising:

a. is configured to have an area in contact with the skin surface of a human body of not less than 0.5cm²A contact surface of (a);

b. an illumination unit configured to generate and project illumination light, the illumination unit comprising a plurality of near-infrared light emitting diodes, each near-infrared light emitting diode capable of emitting at least 0.3W of power,

the cross-sectional area of the irradiation light is not less than 0.5cm²，

The irradiation light is substantially composed of light having a wavelength in a near infrared range of not less than 850nm and not more than 1100 nm; and is

The illumination light has an intensity sufficient to kill at least some fat cells in a human subcutaneous fat layer when projected through a human epidermis; and

c. a cooling unit configured to cool tissue, the cooling unit located in a volume near the contact surface and through which the illumination light passes, a cooling capacity of the cooling unit being at least 0.3W/cm²。

7. The apparatus of claim 6, the illumination unit configured such that the projected illumination light has not less than 0.3W/cm of the wavelength²And not more than 5W/cm²Total power density of (c).

8. The apparatus according to any one of claims 6 to 7, the illumination unit configured to generate the illumination light continuously for not less than 10 minutes.

9. The apparatus of any one of claims 6 to 7, the illumination unit configured to generate the illumination light in a pulsed mode for a duration of not less than 10 minutes, wherein at least one of the following is true:

all light sources in the multiple light sources operate simultaneously at the same duty cycle;

each light source of the multiple light sources operates independently; and

the individual light sources in the multiple light sources are organized in groups, and each group operates at a duty cycle that is independent of the other groups.

10. The apparatus according to any one of claims 6 to 7, the irradiation unit being constituted by light emitting diodes having different wavelengths.

Technical Field

The present invention relates, in some embodiments, to the field of subcutaneous fat, and, in some embodiments, to a non-surgical, non-invasive method of cosmetic treatment to alter the aesthetic appearance of a portion of a human body by killing subcutaneous fat cells, and a device suitable for killing subcutaneous fat cells.

Background

There is a need to alter the aesthetic appearance of a part of the human body, for example by removing subcutaneous fat from that part of the body.

One method of removing subcutaneous fat is by killing adipocytes in the subcutaneous layer, for example, by maintaining the cells at a temperature above 42 ℃ (typically 42 ℃ to 47 ℃) for a period of time to induce apoptosis of the adipocytes.

One challenge is to heat the adipocytes to the required temperature to kill them while keeping the temperature of the epidermis and dermis below 42 ℃ to avoid thermal damage to the skin. Radio frequency heating is insufficient due to the low conductivity of fat. Ultrasonic heating is considered dangerous because the ultrasonic energy may penetrate too deeply into the subject's body, damaging the tissue beneath the subcutaneous layer. A device using a near infrared laser beam with a wavelength of 1060nm (e.g., SculpSure, Sainox, Westford, Mass.). Such laser light is minimally absorbed by the skin and thus passes through the skin without significant attenuation to be efficiently absorbed by the adipocytes, thereby transdermally heating the subcutaneous adipocytes without damaging the skin. Due to the power density of the laser beam, the fat cells within the laser beam are rapidly heated to the point of triggering apoptosis. The laser power required is high (on the scale of tens of watts) due to the relatively large area to be treated, and such devices are very expensive.

Non-invasive methods of altering the aesthetic appearance of a portion of the human body are sought.

Disclosure of Invention

Some embodiments of the invention relate to altering the aesthetic appearance of a portion of the human body by killing subcutaneous fat cells and to devices suitable for killing subcutaneous fat cells. In some embodiments, the method is a non-surgical, non-invasive cosmetic treatment method for altering the aesthetic appearance of a portion of the human body.

Aspects and embodiments of the invention are described in the following specification and appended claims.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the present specification, including definitions, will control.

The terms "comprises," "comprising," "including," "having," and grammatical variations thereof, as used herein, are to be taken as specifying the stated features, integers, steps, or components, but do not preclude the addition of one or more additional features, integers, steps, components, or groups thereof. These terms encompass the terms "consisting of … …" and "consisting essentially of … …".

The indefinite articles "a" and "an" as used herein mean "at least one" or "one or more" unless the context clearly dictates otherwise.

As used herein, the term "about" when preceded by the term "about" is intended to mean +/-10%.

Drawings

Some embodiments of the invention are described herein with reference to the accompanying drawings. This description together with the drawings make apparent to those skilled in the art the manner in which some embodiments of the invention may be implemented. The drawings are for illustrative purposes and are not intended to show structural details of the embodiments in more detail than is necessary for a fundamental understanding of the invention. For purposes of clarity, some objects depicted in the drawings are not drawn to scale.

In the drawings:

FIG. 1 depicts an LED panel suitable for implementing some embodiments of the teachings herein;

FIG. 2 depicts a portion of the panel of FIG. 1 for treating tissue, showing the distribution of light energy within the treated tissue in side cross-section; and

figure 3 depicts a portion of an apparatus including an irradiation enclosure according to the teachings herein.

Detailed Description

Some embodiments of the invention relate to altering the aesthetic appearance of a portion of the human body by killing subcutaneous fat cells and to devices suitable for killing subcutaneous fat cells. In some embodiments, the method is a non-surgical, non-invasive cosmetic treatment method for altering the aesthetic appearance of a portion of the human body.

Before explaining at least one embodiment in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. The invention is capable of other embodiments or of being practiced or carried out in various ways. The phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

As discussed in the background section above, there is a need to change the aesthetic appearance of a portion of the human body. Embodiments taught herein relate to a non-surgical, non-invasive cosmetic method for altering the aesthetic appearance of a portion of the human body.

The teachings herein are based on the following findings: by heating the subcutaneous fat layer with near infrared light having a wavelength in the range between 850nm and 1100nm, adipocytes in the subcutaneous fat layer of a human body can be transdermally killed with few side effects.

Without wishing to be bound by any theory, it is presently believed that illumination light consisting essentially of wavelengths in the near infrared range described above is not substantially absorbed by the skin and is therefore able to effectively pass through the epidermis and dermis with sufficient intensity to be absorbed by the adipocytes and to heat them to a temperature above 42 ℃ (typically 42 ℃ to 47 ℃) and for a time sufficient to initiate apoptosis, thereby killing at least some of the adipocytes.

It has also been found that, under the effect of the duration and intensity of light in the near infrared range of wavelengths required to kill adipocytes in the subcutaneous layer, the light is sufficiently absorbed by collagen in the subcutaneous layer to stimulate collagen formation without damaging the collagen. This coincidentally results in transdermal heating according to the teachings herein providing skin tightening while providing an adipocyte killing effect, thereby providing an improved aesthetic appearance of a portion of the human body sculpted by killing adipocytes with a lower incidence of skin relaxation.

In order to avoid damage to the epidermis due to burns, it is generally necessary to keep the temperature of the part of the epidermis through which the illuminating light passes below 42 ℃. It has been found that the dermis and epidermis are not substantially damaged by the duration and intensity of light in the near infrared range of wavelengths required to kill adipocytes in the subcutaneous layer if the epidermis is sufficiently cooled.

Method for changing the contour of a part of a human body

Thus, according to an aspect of some embodiments taught herein, there is provided a non-surgical, non-invasive cosmetic method of altering the aesthetic appearance of a portion of the human body by killing subcutaneous fat cells, comprising:

a. irradiating light through a portion of the epidermis of a subject, transdermally heating a portion of the subcutaneous fat layer of the subject using incoherent multiple light sources, the irradiating light having a cross-sectional area at the surface of the epidermis of a thickness sufficient in size to be greater than the thickness of the skin thickness, the heating sufficient to kill and/or induce apoptosis of at least some adipocytes in the portion of the subcutaneous fat layer; and

b. cooling the portion of the epidermis sufficiently to prevent burning of the epidermis while the transdermal heating,

wherein the irradiation light is substantially composed of light having a wavelength in a near infrared range of not less than 850nm and not more than 1100nm,

thereby destroying adipocytes in the portion of the subcutaneous fat layer.

According to an aspect of some embodiments of the teachings herein, there is also provided a method of altering the appearance of a portion of a human body by killing subcutaneous fat cells, comprising:

a. transdermally heating a portion of a subcutaneous fat layer of a subject using incoherent multiple light sources illuminating light through a portion of an epidermis of the subject, the illuminating light having a cross-sectional area at a surface of the epidermis of a thickness sufficient in size to be greater than a thickness of a skin thickness, the heating sufficient to kill at least some adipocytes in the portion of the subcutaneous fat layer; and

b. cooling the portion of the epidermis sufficiently to prevent burning of the epidermis while the transdermal heating,

wherein the light beam is substantially composed of light having a wavelength in a near infrared range of not less than 850nm and not more than 1100nm,

thereby destroying adipocytes in the portion of the subcutaneous fat layer.

In some embodiments, the total power density of the illumination light at the wavelength in the near infrared range is not less than 0.3W/cm²And not more than 5W/cm²。

In some embodiments, transdermal heating of the subcutaneous fat layer of the subject is performed for at least one treatment session, wherein each volume of the subcutaneous fat layer being treated is continuously transdermal heated for a duration of at least 10 minutes.

As described above, the illumination light is incoherent multi-light-source illumination light. In some embodiments, the light is generated by a matrix of high power light emitting diodes.

In some embodiments, the cooling comprises contacting the portion of the skin with a cooling surface of a physical component, the surface having a temperature between 5 ℃ and 20 ℃. In some embodiments, the cooling surface is a surface of an optical element through which the illumination light passes.

In some embodiments, the method further comprises: applying suction to the portion of the epidermis while the transdermal heating, thereby drawing tissue comprising the portion of the epidermis into the irradiation enclosure. In some embodiments, this aspiration of tissue into the irradiation enclosure positions the epidermis in a designated location for better cooling and/or subcutaneous fat for better heating by the illuminating light.

In some embodiments, the method further comprises: mechanically sucking tissue comprising the portion of the epidermis into an irradiation enclosure while the transdermal heating. In some embodiments, this suction of tissue positions the epidermis in a designated location for better cooling and/or subcutaneous fat for better heating by the illuminating light.

In some embodiments, the aspiration of tissue is such that the portion of the subject's subcutaneous fat layer to be heated is located within the irradiation enclosure; the illumination light is projected onto the entire irradiation enclosure such that at least some of the illumination light travels in the following directions: through the portion of the epidermis, through the portion of the subcutaneous fat layer, and out through the opposite portion of the epidermis.

In some embodiments, the method further comprises applying a pulsed electromagnetic field to a volume of tissue comprising the portion of the epidermis, the underlying dermis, and the portion of the subcutaneous fat layer while the transdermal heating is occurring. In some embodiments, the field strength of the pulsed electromagnetic field is not less than 10 gauss and not more than 30 gauss, and the magnetic pulse frequency of the pulsed electromagnetic field is not less than 0.1Hz and not more than 100 Hz. It has been found that the simultaneous application of pulsed electromagnetic fields leads to advantageous results. Without wishing to be bound by any one theory, it is presently believed that this simultaneous application of a pulsed electromagnetic field results in faster clearance of fat cell debris and/or stimulates faster collagen formation. The pulsed electromagnetic field may be applied using any suitable device, for example, generated by a commercially available pulsed electromagnetic field therapy (PEMFT) device.

In some embodiments, the method further comprises: determining a temperature of the portion of the subcutaneous fat layer during the transdermal heating; and

reducing the intensity of the illumination light if the determined temperature is higher than a predetermined maximum temperature; and

increasing the intensity of the illumination light if the determined temperature is below a predetermined minimum temperature.

Any suitable device or combination of devices may be used to implement methods in accordance with the teachings herein. Some embodiments are preferably implemented using an apparatus according to the teachings herein.

Apparatus according to the teachings herein

There is also provided, according to an aspect of some embodiments of the teachings herein, a device suitable for transdermally killing adipocytes in a subcutaneous fat layer of a subject, the device comprising:

a. is not small in the area configured to contact with the skin surface of the human bodyAt 0.5cm²A contact surface of (a);

b. an illumination unit configured to generate and project illumination light, the illumination unit comprising a plurality of near-infrared Light Emitting Diodes (LEDs), each near-infrared light emitting diode capable of emitting at least 0.5W of power,

the cross-sectional area of the irradiation light is not less than 0.5cm²，

The irradiation light is substantially composed of incoherent light having a near infrared wavelength in a range of not less than 850nm and not more than 1100nm, and

the illumination light has an intensity sufficient to kill at least some fat cells in a human subcutaneous fat layer when projected through a human epidermis; and

c. a cooling unit configured to cool tissue, the cooling unit located in a volume near the contact surface and through which the illumination light passes, a cooling capacity of the cooling unit being at least 0.3W/cm²。

In some embodiments, the illumination unit is configured such that a total power density of the wavelengths of the illumination light in the near infrared range is not less than 0.3W/cm²And not more than 5W/cm²。

In some embodiments, the LEDs are arranged on the support structure at a density of 0.25-4 LEDs per square centimeter.

In some preferred embodiments, the irradiation unit includes: a matrix of said near infrared LEDs spaced apart a distance of not less than 0.5cm and not more than 2 cm; and a contact surface made of a material with high thermal conductivity (e.g. sapphire); and the cooling unit is included between the LED rows.

In some embodiments, the illumination unit is configured to generate the illumination light continuously for no less than 10 minutes.

In some embodiments, the cooling unit is configured to maintain the temperature of the contact surface at a temperature between 5 ℃ and 20 ℃. In some embodiments, the contact surface is a surface made of a transparent element through which the illumination light passes.

In some embodiments, the apparatus further comprises a cooling block;

the cooling unit is configured to maintain a temperature of the cooling block at a temperature of less than 20 ℃;

and is

The device is configured such that during use of the device, when the contact surfaces are in contact

The cooling block contacts the skin surface to absorb heat from the skin surface when the skin surface is exposed.

In some embodiments, the cooling unit comprises at least one cooling block, each cooling block being located between the rows of LEDs.

In some embodiments, the cooling block forms a portion of an irradiation enclosure having a rim; and the illumination unit is configured to project the illumination light into the irradiation enclosure towards a plane defined by the rim.

In some embodiments, the apparatus further comprises an irradiation enclosure having a sealed rim; and a suction generator configured to draw air from inside the irradiation enclosure. In some embodiments, the illumination unit is configured to project the illumination light into the irradiation enclosure towards a plane defined by the sealing rim.

In some embodiments, the irradiation enclosure comprises a window through which the illumination light is transmitted; and the illumination unit is configured to project the illumination light through the window into the irradiation enclosure towards a plane defined by the sealing rim.

In some embodiments, the apparatus comprises windows positioned at least on two opposing sides of the irradiation enclosure; wherein the included angle between the two opposite side surfaces is not more than 90 degrees. In some embodiments, the included angle between the two opposing sides is no greater than 60 °. In some embodiments, the included angle between the two opposing sides is no greater than 30 °.

In some embodiments, the apparatus further comprises: a pulsed electromagnetic field generator configured to generate a pulsed electromagnetic field in a volume near the contact surface that includes illumination light projected by the illumination unit. In some embodiments, the pulsed electromagnetic field generator is configured to generate a pulsed electromagnetic field having a field strength between 10 gauss and 30 gauss and a magnetic pulse frequency between 0.1Hz and 100 Hz. In some embodiments, the pulsed electromagnetic field generator comprises a coil with a ferromagnetic core for generating the pulsed electromagnetic field.

Wavelengths for implementing the teachings herein

As described above, a method according to the teachings herein includes transdermally heating a portion of a subcutaneous fat layer of a subject with illuminating light, wherein the illuminating light consists essentially of light having a wavelength in the near infrared range of not less than 850nm and not greater than 1100nm, thereby destroying fat cells in the portion of the subcutaneous fat layer and compactly stimulating collagen formation in the subcutaneous layer without damaging the dermis as described above.

The wavelength may be selected according to the desired penetration depth.

Accordingly, an apparatus according to the teachings herein includes an illumination unit configured to generate and project illumination light consisting essentially of light having a wavelength in the near infrared range of no less than 850nm and no more than 1100 nm.

Preferably, the wavelength is selected from the range of 900nm to 920 nm; 940nm to 960 nm; and a near infrared range of the group consisting of 1010nm to 1100 nm. In some preferred embodiments, the range is 940nm to 960 nm. It has been found that in a more preferred range, the fat cell killing effect and collagen production stimulating effect are improved.

As used herein, the term "illuminating light consisting essentially of light having a wavelength in the near-infrared range" means that the total intensity of near-infrared light of the illuminating light having a wavelength in the range is, in some embodiments, not less than 50%, 80%, and even 90% of the total intensity of all near-infrared light, as compared to the total intensity of all near-infrared light (750nm to 1400nm) of the illuminating light. This preference for light having a wavelength in the near infrared range is to ensure that the desired physiological effect is achieved without damaging the tissue by irradiation with near infrared light having a wavelength below or above the wavelength in the range.

A non-limiting example of a panel 10 is depicted in fig. 1, the panel 10 serving as a component of an illumination unit of an apparatus according to the teachings herein. The panel 10 comprises 56 individual LEDs 12 (with a centroid wavelength of 940nm and a FWHM of 930nm to 965nm) arranged in a 7x 8 matrix, which LEDs 12, when activated, produce light through a rectangular (5cm x 7cm) cooled sapphire window 14 as illumination light with a cross-sectional area of 35cm². The panel 10 is configured to allow each LED 12 to be activated individually, independently, or with any other number of the other fifty-five LEDs 12. Since each LED 12 is capable of emitting 1000mW of near infrared light, the panel 10 is capable of producing a cross-sectional area of 35cm²The power density is 1.6W/cm²The light of (1).

In fig. 2, the panel 10 is shown in partial side cross-section (only three LEDs 12 of a row of seven LEDs are depicted), with a sapphire window 14 serving as a contact surface in contact with the epidermis 16 of the subject. An aluminum frame 18 is clearly visible in fig. 2 through which a coolant conduit 20 (shown in cross-section) passes and is configured to convey a cooling liquid, such as water, to cool the LEDs 12 and the window 14 during operation of the apparatus including the panel 10. Below the epidermis 16, grey shading qualitatively depicts the temperature of the tissue heated by the illumination light produced by the panel 10.

In fig. 3, a portion of a device 22 according to the teachings herein is shown partially cut away, the device 22 comprising two panels 10a and 10b as described above arranged at 90 ° to each other and partially defining an irradiation enclosure 24 comprising a silicone rubber sealing rim 26, said silicone rubber sealing rim 26 constituting a contact surface of the device 20. Also seen is a suction system 28 configured to draw air from the irradiation enclosure 24. During use of the device 22, the sealing rim 26 is placed in contact with a portion of the subject's epidermis, and the suction system 28 is activated to generate and project illumination light in accordance with the teachings herein while the LEDs 12 of the panels 10a and 10b are activated. Suction generated by suction system 28 draws tissue into irradiation housing 24.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment is inoperable without those elements.

While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variances which fall within the spirit and scope of the appended claims.

Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Section headings are used herein to simplify understanding of the description and should not be construed as necessarily limiting.