WO2013191699A1

WO2013191699A1 - Cooling device for lipid-rich cell disruption

Info

Publication number: WO2013191699A1
Application number: PCT/US2012/043540
Authority: WO
Inventors: Liliana Paez
Original assignee: Liliana Paez
Priority date: 2012-06-21
Filing date: 2012-06-21
Publication date: 2013-12-27
Also published as: MX2012012158A

Abstract

The present invention is directed to a device for cooling and disrupting subcutaneous fat cells in a subject. The device is composed of a cooling assembly with a cooling surface, a control module with control inputs, and a handheld, portable enclosure. The enclosure encompasses all components such that the device is compact and portable.

Description

COOLING DEVICE FOR LIPID-RICH CELL DISRUPTION

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a handheld or mobile device used in connection with and for the disruption of subcutaneous, lipid-rich cells. In particular, the device of the various embodiments of the present invention comprises an internal cooling assembly and an external cooling surface which is applied to the surface of a subject's skin, or in certain embodiments, an intermediate membrane disposed between the subject's skin and the cooling surface. Over the course of a predetermined amount of time, the cooling surface is structured to disrupt, cool or freeze the subcutaneous, lipid-rich cells, which are then ultimately removed by the natural processes of the body.

Description of the Related Art

Obesity is a major problem, increasing the likelihood of developing numerous types of diseases, such as heart disease, diabetes, and high blood pressure. Aside from the negative health consequences, body fat also detracts from one's personal appearance by forming cellulite, which can manifest in the malformation of the surface of the skin.

There are numerous surgical methods for removing excess body fat, such as liposuction and "tummy tucks"; however, such procedures are invasive surgical procedures and can have painful recovery times . Also, such procedures can sometimes prove fatal from complications from the procedures.

There are various "non-surgical" procedures for battling excessive body fat as well. These include weight-loss pills, exercise, and diet. However, some people do not find benefits in these procedures because of busy schedules, ineffective methods, and/or other health problems that prevent use of such procedures.

Others have recently described newer methods of reducing subcutaneous fat cells, which involve the controlled cooling of lipid-rich cells causing damage to the cells targeting them for natural removal processes by the body. During the cooling process, the epidermal and subdermal regions of the target area are cooled by a device. Lipid-rich cells are more sensitive to the lower temperatures compared to the surrounding cells causing selective damage to lipid-rich cells while sparing the surrounding non-lipid rich cells. Once the lipid-rich cells are damaged by the lower temperatures, they are ultimately removed by the natural processes of the body.

One of the drawbacks of the cooling method described is that it requires rather expensive, large and bulky equipment which significantly limits the availability of treatment. Thus, there is a significant need for less-expensive, portable devices that can provide a "cooling" effect to subcutaneous lipid-rich cells while allowing for treatments in a variety of locations and conditions, opening up the availability of such procedures to a larger population . Summary of the Invention

The present invention described herein addresses the need for an apparatus that facilitates the ability to cool, freeze and/or otherwise disrupt lipid-rich cells without the need for large and cumbersome equipment. As such, the present invention is directed to a portable and handheld device for disrupting subcutaneous fat cells in a subject.

In particular, the device of the various embodiments of the present invention includes at least one cooling assembly, which in turn, comprises a corresponding cooling surface. Specifically, when disposed in an operating position in contact with the surface of a subject's skin, the cooling surface of the present invention is structured to decrease the temperature of subcutaneous fat cells within the subject and substantially adjacent the contact area of the subject's skin. In particular, operational use of the device is obtained when the device is turned on or otherwise when the cooling surface is structured to maintain a predetermined temperature, and when the cooling surface is place in contact with the subject's skin or an intermediate membrane.

As will be described in further detail herein, the device of the various embodiments further includes a control module with one or more control inputs. The control inputs are controllably linked to the cooling assembly via internal control circuitry and corresponding software and/or hardware components. Specifically, the control inputs are structured to turn the device on or off, program the device to automatically turn off after a selected or predetermined time, or in order to select a temperature or operational mode.

Moreover, in order to facilitate ease of use, use of the device in a subject's home, and/or personal use of the present invention, in at least one embodiment, each of the aforementioned components of the device is contained in a single portable enclosure or housing which is structured to be in the form of a handheld device. In one embodiment, the handheld device further comprises a securing assembly, preferably in the form of a belt or other like structure, which is capable of securing the device in a predetermined operating position against the subject's skin. Therefore, while the device of at least one embodiment is considered handheld by virtue of the small, compact configuration of the single enclosure, the securing assembly of one embodiment will securely hold the device in place without the need for the user to continuously hold the device against the subject's skin during operation.

Furthermore, another aspect of the enclosure is that the cooling assembly is disposed and configured within the enclosure such that the cooling surface thereof is exposed externally of the enclosure. In other words, the cooling surface is exposed on the outside of the enclosure or housing in order to facilitate direct contact with the subject's skin or other operational contact area.

For example, in one embodiment, the present invention further comprises an intermediate membrane disposed between the subject's skin and the cooling surface. The membrane, which may be in the form of a glycerin membrane and/or a gelatinous substance, is structured to minimize or prevent disruption or damage to the outer skin layer of the operational contact area of the subject's skin .

These and other objects, features and advantages of the present invention will become clearer when the drawings as well as the detailed description are taken into consideration.

Brief Description of the Drawings

For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which :

Figure 1 illustrates a perspective view of a device as disclosed in accordance with at least one embodiment of the present invention.

Figure 2 illustrates a side view of the device of the present invention .

Figure 3 illustrates a side view of the device of the present invention .

Figure 4 illustrates a top view of the device of the present invention .

Figure 5 illustrates a bottom view of the device of the present invention showing the cooling surface.

Figure 6 illustrates the device of the present invention being placed on an area of skin on a subject.

Figure 7 illustrates the device of the present invention being placed on an area of skin on a subject with a belt attached. Like reference numerals refer to like parts throughout the several views of the drawings .

Detailed Description of the Preferred Embodiment

As shown in the accompanying drawings, and with particular reference to FIGURE 1, the present invention is directed to a handheld apparatus or device that facilitates the ability to perform cooling of lipid-rich cells without the need for large and cumbersome equipment. Several aspects of the invention are described below, with reference to the drawings for illustrative purposes only. It should be understood that numerous specific details and relationships are set forth to provide a full understanding of the invention. One having ordinary skill in the relevant art, however, will readily recognize that the invention can be practiced without one or more of the specific details .

Unless otherwise defined, all terms of art, notations and other scientific terms or terminology used herein are intended to have the meanings commonly understood by those of skill in the art to which this invention pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and/or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and/or as otherwise defined herein.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the indefinite articles "a", "an" and "the" should be understood to include plural reference unless the context clearly indicates otherwise.

The phrase "and/or," as used herein, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases.

As used herein, "or" should be understood to have the same meaning as "and/or" as defined above. For example, when separating a listing of items, "and/or" or "or" shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number of items, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of, " or, when used in the claims, "consisting of, " will refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e., "one or the other but not both") when preceded by terms of exclusivity, such as "either, " "one of, " "only one of," or "exactly one of."

As used herein, the terms "including", "includes", "having", "has", "with", or variants thereof, are intended to be inclusive similar to the term "comprising."

As used herein, the term "subcutaneous" is used in reference to the tissues and cells lying beneath the dermis. Such layers include subcutaneous fat, which are composed of lipid-rich cells, or adipocytes. Lipid-rich cells may have a total intracellular lipid content of between about 20% to about 99%, which may be composed of about 20% to about 50% saturated triglycerides.

With primary reference to FIGURES 1, 2 and 3, the present invention is directed to a device, generally indicated as 10, for disrupting and cooling subcutaneous fat cells in a subject. The device 10 includes a cooling assembly 100, which comprises a cooling surface 110. The cooling surface 110 is structured to decrease the temperature of subcutaneous fat cells when applied to the skin surface of the subject. In particular, as described herein, when the cooling surface 110 is disposed in contacting relation with an operational contact area, e.g., an area of the subject outer skin, and the device is turned on or operating such that the cooling surface 110 is cooled, as described herein, the subcutaneous fat cells adjacent the operational contact area will be cooled or disrupted to the point that the cells will thereafter be removed from the body via the body's natural occurrences. In particular, when exposed to cold temperatures from the device 10 of the present invention, the cells will crystallize, die and will not thereafter regenerate. The cells are then eliminated through the subject's liver via a process called apoptosis.

Further, the operational contact area may be virtually any location on the subject, including, but certainly not limited to, the subject's abdominal region or any extremities including the arms and legs. The cooling surface 110 of the various embodiments is structured for disposition directly against or in contact with the subject's skin at the operational contact area. However, as will be described below, certain embodiments further include the use of an intermediate membrane and/or substance in order to protect the outer surface layer of the subject's skin.

The device 10 further includes a control module or internal control circuitry (not shown) with one or more external control inputs 210. In particular, the control inputs 210 are controllably linked to the cooling assembly of the present invention in order to preprogram or preset the device 10 to be disposed in an "on" or operational mode for a certain desired amount of time.

Furthermore, each of the aforementioned components of the device 10 is contained in a single enclosure or housing 300 which, in certain embodiments, is structured to be in the form of a handheld device. Specifically, as shown in FIGURE 1, the device of at least one embodiment of the present invention comprises one or more handholds or handles 310 configured to be grasped by a subject or person treating an area on a subject. In other embodiments, described below, the handholds 300 may also function as part of a securing assembly in that a belt, strap or other securing device may pass through the handhodls and secure the device to the user.

Particularly, the device 10 of the various embodiments comprises a single, compact enclosure thereby allowing the device 10 to be used in leisure of a subject's home and by the subject, without the need for assistance or physician supervision. As can be appreciated by the description herein, the device 10 of the present invention is operational without the use of anesthesia and is non-invasive.

Another aspect of the enclosure 300 is that the cooling assembly 100 is disposed and configured within the enclosure 300 such that the cooling surface 110 is exposed externally of the enclosure 300. The control module is also disposed within the enclosure 300 such that the control inputs 210 are externally exposed . As shown in FIGURES 1 and 2, one of the control inputs 210 is an ON/OFF button 212. As shown in FIGURE 3, some of the control inputs 210 are timing buttons 214 that control the length of time the cooling assembly 100 is in operation, thus providing an automatic turn-off once the requisite/desired length of time is attained. The control module interacts with the cooling assembly 100 to automatically turn off the cooling assembly 100 once the requisite time is reached. Such timing buttons 214 may provide timing increments, for example, of 5, 15, 30, or 60 minutes by pressing the proper button. The buttons may also be illuminated in order to provide a visual indicator of the timing to be utilized.

The cooling assembly of the various embodiments of the present invention may employ a variety of cooling technologies known in the art, such as, but certainly not limited to, thermoelectric coolers, recirculating chilled fluid, phase change cryogenic devices, and vapor compression elements. Any current or future cooling technology will be useful in the present invention as long as it is capable of decreasing the temperature of subcutaneous fat cells when applied to the skin surface of the subject. Regardless of the technology utilized, the entire cooling assembly 100 (aside from any electrical cord and power adaptor) is contained within the enclosure 300 such that the device 10 is self-contained, handheld and portable. Also, no high- voltage power supplies are necessary. Because of the self- contained aspect of the device 10, it may include a heat dissipating structure 120, such as a heatsink, as illustrated in FIGURE 4. In some embodiments, the cooling surface 110 may be a Peltier-type thermoelectric element. The cooling surface 110 is capable of cooling subcutaneous, lipid-rich cells. In at least one embodiment of the present invention, the cooling surface 110 is structured to maintain a temperature of between about -lOoC and OoC, and in preferred embodiment between -4oC and -2oC.

The cooling surface 110 may be in a planar (flat) configuration, as illustrated in FIGURE 5, or in a non-planar configuration (e.g., curved inwardly or outwardly) . The various planar and non-planar configurations allow for ease of use in a variety of positions on the human body. Furthermore, the cooling surface 110 may be constructed of a variety of materials that are capable of providing thermal conductivity great enough to provide for the rapid and continual cooling of subdermal tissue, as would be understood by those skilled in the art, and in order to facilitate the practice of the present invention in the intended manner. Exemplary materials include, but are certainly not limited to metal alloys, aluminum, graphite, ceramics, polymers, composite materials and the like.

As illustrated in FIGURE 6, the device 10 may be utilized in connection with an intermediate membrane M disposed between the cooling surface 110 and the subject's body region BR. In particular, the intermediate membrane M is structured to protect the outer skin layer of the operational contact area of the subject's skin from damage or disruption resulting from the cooling temperatures of the cooling surface 110. Accordingly, such membranes M may be composed of any substrate and/or solution that would be understood by those skilled in the art to effectively and efficiently provide a buffer between the subject's body region BR and the cooling surface 110 in order to prevent any skin surface damage by the cooling of the cooling surface 110. In some embodiments, a glycerin membrane may be utilized. In particular, the membrane M of at least one embodiment comprises a cloth soaked in a glycerin solution or other solution. As an example, the cloth may be prepackaged in the solution such that when removed from the packaging, the cloth or membrane M is precoated in the solution and ready for disposition between the subject's skin and the cooling surface 110. In other embodiments, the cloth or other structure may be mixed with the solution at the time of use and then disposed between the subject's skin and the cooling surface. It should also be noted that some membranes M of the various embodiments may be utilized multiple times, whereas other membranes M may be structured or intended for single use only. The membrane M of a preferred embodiment is sized and configured to cover the entire cooling surface 110 of the device 10 such that the cooling surface 110 does not directly contact the subject's skin. As an example, the membrane M may be approximately the size of an 8.5 x 11 sheet of paper, or otherwise big enough to cover the cooling surface 110, as just described.

In some embodiments, as illustrated in FIGURE 7, the device 10 may also include a securing assembly or belt 400. Specifically, the belt or securing assembly 400 of certain embodiments is configured to engage the enclosure 300 or device 10 such that the device 10 can be securely and releasably positioned on a body portion of a subject. Moreover, as illustrated, the belt 400 may be configured such that it attaches to or engages with one or more of the handholds 310 of the device 10. The belt 400 may either directly attach to one or more of the handholds 310 or run through one of the handholds 310, across the back surface of the device 10 and then through another handhold 310. It should be noted that the securing assembly 400 may be removably secured or attached to the device 10, and in particular the housing 300 thereof. However, in other embodiments, the securing assembly 400 may be permanently secured or attached to one or more portions of the housing 300. Any securing assembly 400 or device structured to facilitate implementation of the present invention in the intended manner may be used, including, but certainly not limited to a VELCRO closure belt, or a belt, strap or other securing device comprising snaps, buttons, loops, etc. In any event, the securing assembly 400 of the various embodiments should not interfere with the cooling surface 110 and should therefore not be disposed across the cooling surface 110 or between the cooling surface 110 and the membrane M or operational contact area such as the subject's skin.

The device may additionally include one or more temperature sensors configured or disposed proximate to the cooling surface 110. In particular, the temperature sensor (s) of such an embodiment may be configured to be flush with the cooling surface 110, below the cooling surface 110, or protrude from the cooling surface 110. In any event, the temperature sensor (s) may be communicatively connected to the control module or internal circuitry for providing temperature readings of the cooling surface 110 and/or the surface of the subject's skin. The temperature sensor (s) provide temperature readings to the control module in order for the control module to control the operation of the cooling assembly 100 in maintenance of the proper operating temperatures for effective and safe cooling of the subcutaneous lipid-rich cells.

It is to be appreciated that the foregoing Detailed Description section, and not the Abstract section, is intended to be used to interpret the claims. The Abstract section may set forth one or more, but not all, exemplary embodiments of the present invention as contemplated by the inventor (s), and thus, is not intended to limit the present invention and the appended claims in any way.

The foregoing description of the specific embodiments should fully reveal the general nature of the invention so that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents . Moreover, the breadth and scope of the present invention should not be limited by any of the above-described exemplary and illustrative embodiments, but should similarly be defined only in accordance with the following claims and their equivalents.

Now that the invention has been described,

Claims

1. A device for disrupting subcutaneous fat cells in a subject, said device comprising:

a cooling assembly, said cooling assembly comprising a cooling surface, wherein said cooling surface decreases the temperature of subcutaneous fat cells when applied to the skin surface of the subject;

a control module with control inputs, said control module controllably linked to said cooling assembly; and

a single portable enclosure structured to be in the form of a handheld device, wherein said cooling assembly is disposed within said enclosure such that said cooling surface is exposed externally of said enclosure, wherein said control module is disposed within said enclosure such that said control inputs are exposed externally of said enclosure.

2. The device as recited in claim 1 wherein said portable enclosure comprises two oppositely disposed handles configured to facilitate a subject's gripping engagement therewith.

3. The device as recited in claim 2 further comprising a securing assembly configured and attached to said enclosure such that the device can be securely positioned on a body portion of the subject.

4. The device as recited in claim 3 wherein said securing assembly is removably attached to said enclosure.

5. The device as recited in claim 4 wherein said securing assembly comprises a belt positioned through said two oppositely disposed handles.

6. The device as recited in claim 1 further comprising a temperature sensor configured proximate to said cooling surface, wherein said temperature sensor is communicatively connected to said control module for providing temperature readings of said cooling surface .

7. The device as recited in claim 1 further comprising an intermediate membrane disposed between said cooling surface and the skin surface of the subject during operation use of said device .

8. The device as recited in claim 7 wherein said membrane is sized larger than said cooling surface.

9. The device as recited in claim 7 wherein said intermediate membrane comprises a glycerin membrane.

10. The device as recited in claim 7 wherein said membrane comprises a cloth material presoaked in glycerin solution.

11. The device as recited in claim 1 wherein said cooling surface is maintained at a temperature between approximately -5oC and OoC during operational use of said device.

12. The device as recited in claim 11 wherein said cooling surface is maintained at a temperature between approximately -4oC and -2oC during operational use of said device.

13. A handheld, portable device for disrupting subcutaneous fat cells in a subject, said device comprising:

a portable enclosure,

a cooling assembly disposed at least partially within said portable enclosure, said cooling assembly comprising a cooling surface disposed external to said portable enclosure, said cooling surface being structured to decrease the temperature of subcutaneous fat cells when applied to the skin surface of the subject,

a control module disposed within said portable enclosure, said control module controllably linked with a plurality of control inputs ,

a securing assembly removably disposed in securing relation with a selected portion of the subject's body, wherein said cooling surface is disposed in a facing relation with the skin of the subject, and

an intermediate membrane disposed between said cooling surface and the skin surface of the subject.

14. The device as recited in claim 13 wherein said portable enclosure comprises at least one handle structured for gripping engagement by the subject.

15. The device as recited in claim 14 wherein said portable enclosure comprises two oppositely disposed handles .

16. The device as recited in claim 15 wherein said securing assembly comprises a belt removably disposed through said two oppositely disposed handles .

17. The device as recited in claim 13 wherein said cooling surface is maintained at a temperature between approximately -4oC and -2oC during operational use of said device.

18. The device as recited in claim 13 wherein said intermediate membrane comprises a glycerin infused membrane.