Apparatus for adipose tissue treatment

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Λ DEVICE, APPARATUS, AND METHOD OE ADIPOSE TISSUE TREATMENT

TECHNICAL FIELD

[00011 The present device, apparatus, and method relate to the Field of adipose tissue treatment and aesthetic body sculpturing.

BACKGROUND 100021 Liposuction is a technique for removal of fat tissue from different sites in a particular human body. The process changes the external contours of (he body and is sometimes described as body sculpturing. The fat is removed by a suction device via a cannula inserted into the appropriate site in the body. The process is painful and sometimes causes excessive bleeding.

[0003J Recently, liposuction procedures have been improved by the use of infrared laser radiation delivered through a fiber inserted into a cannula and introduced into the treated tissue site. Laser radiation liquefies the adipose tissue. The liquefied tissue is either removed by suction or left in the body, where it gradually dissipates. Laser assisted liposuction is considered to be a more advanced and minimally invasive procedure when compared to traditional liposuction techniques.

[0004] High temperature developed at the tip of the fiber causes frequent fiber lip carbonization, forcing the treatment provider to remove the fiber, clean the carbonized end or cleave the end and insert it back into the cannula for treatment continuation, fhe cannula with the liber also has to be removed for liquefied tissue suction performed through the same skin port. The liber and the cannula have to be sterilized between the different processes and patients. Alternatively, a new sterile liber and cannula should be used. All of the above slows down the process, increases both discomfort to the treated subject and the cost of the treatment. 100051 The industry would welcome a suitable solution to these and other existing problems.

BRIEF LIST OF DRAWINGS 100061 The disclosure is provided by way of non-limiting examples only, with reference to the accompanying drawings, wherein:

Docket /32-QI4-IL

Page 2 [0007] Figure 1 is a schematic illustration of the first exemplary embodiment of a disposable laser radiation conveying needle.

[0008] Figure 2 is a schematic illustration of a cross section of the needle of Figure 1. |0009J Figures 3A and 3B are schematic illustrations of additional exemplary needle cross sections.

[0()01()] Figure 4 is a schematic illustration of the second exemplary embodiment of a disposable laser radiation conveying needle with a carbonization resisting tip.

[00011] Figure 5 is a schematic illustration of an exemplary embodiment of the apparatus for laser assisted liposuction employing the present needle.

[00012] Figures 6A - 6C are schematic illustrations of the third exemplary embodiment of a disposable laser radiation conveying needle with liquefied fat removal channels.

[00013] Figure 7 is a schematic illustration of an apparatus and method of tissue treatment employing the present disposable laser radiation conveying needle.

[0()014] Figure 8 is a schematic illustration of the fourth exemplary embodiment of a disposable laser radiation conveying needle.

[ 00015 ] Figure 9 is a schematic illustration of an additional exemplary embodiment of an apparatus for laser assisted liposuction employing the present needle.

DIZ ! AILED DESCRIPTION OF EXEMPLARY EMBODMENTS

[00016] The principles and execution of the device, apparatus, and method described thereby may be understood with reference to the drawings, wherein like reference numerals denote like elements through the several views and the accompanying description of non- limiting, exemplary embodiments.

[00017] The term "needle," as used in the text of the present disclosure, means a flexible or rigid light guide configured to be inserted into the subject tissue to deliver laser radiation to a target volume of adipose tissue. In certain embodiments, the needle can be configured to withdraw liquid from the target volume in addition to the above.

[00018] Reference is made to Figure 1, which is a schematic illustration of the llrst exemplary embodiment of a disposable laser radiation conveying needle. Needle 100 is practically a needle shaped solid or hollow light conducting body 104 having a first end 108 and a second end I 12. (In the context of the present disclosure "light" and

Docke! 132-OI-f-H,

Page 3 "laser radialion” have the same meaning.) hirst end 108 can be shaped lor piercing and penetrating the skin of a subject (not shown) and the second end I 12 depending on the length of the needle is adapted to connect directly to a source of laser radialion by means of liber optics type connector 1 16 or with the help of an additional interim cable. The length of needle 100 may vary from a few millimeters to a few hundred millimeters and depends on the type of treatment required. The connection to the source of laser radiation may be performed by any type of fiber optics or similar type connectors. Line 118 designates the optical axis of needle 100. 100019j figure 2 is a cross section of needle 100 that has a round cross section. Needle 100 includes a solid light conducting core 120, a cladding 124 having a refractive index lower than core 120, and a protective jacket 128 that protects the sensitive fiber and provides the necessary rigidity to the needle. In some embodiments shown in figures 313 and 3C the jacket 132 may have an elliptical (figure 313) or polygonal 136 (figure 3C) cross section. The diameter of core 3 20 may be 100 micron to 1500 micron, the diameter of cladding 124 may be 200 micron to 2500 micron and the size of jacket 128, 132, and 136 may be 500 micron to 3000 micron or even more. Connection of needle body 104 to connector I 16 may be performed by crimping, epoxy glue, or any other well known means that is established in the liber optics industry. 100()2()] first end 108 of needle 100 may be shaped for piercing the skin of a subject and may be terminated by a plane perpendicular to the optical axis 1 18 or oriented at an angle to the optical axis 118 of needle 100. Alternatively, end 108 may have a radius or an obtuse angle. In such case, the skin incision is made by any well known surgical means and the needle is introduced into the tissue. Other needle end 108 shapes that improve either skin penetration properties or laser power delivery quality are possible.

[000211 In an alternative embodiment, laser radialion emitted through the end of needle 100 assists needle 100 into the skin penetration process by providing a skin incision suitable for continuous or pulsed laser power. Such laser-performed incision may be advantageous in some aspects since it is accompanied by a simultaneous haemostatic effect, which coagulates the blood, reduces patient bleeding and shortens the recovery period.

Docket 132-014-11.

Page 4 1000221 In the second exemplary embodiment of a disposable laser radiation conveying needle shown in Figure 4, the First end 108 of needle 100 is terminated by a sapphire, YAG (Yttrium Aluminum Garnett), or diamond plate 140, or coating. During use, certain materials resulting from interaction of the tissue with high laser power, deposit on end 108 of needle 100. These carbonized deposits increase laser light absorption at the end 108 of needle 100 and this deposit should be periodically removed. Strong laser power absorption in carbonized deposit can increase local temperature at the end 108 resulting in needle damage. Sapphire, YAG, and diamond or similar material are generally resistant to high temperature and their use as a termination of the first end 108 of needle 100 significantly improves needle life, and its carbonization resistance.

[00023j Figure 5 is a schematic illustration of an exemplary embodiment of an apparatus for laser assisted liposuction employing the present needle. Connector 1 16 connects needle 100 via an optical cable 156 to a source of laser radiation 160 configured to provide laser radiation emitted by one or more lasers incorporated in the source to needle 100. Laser radiation source 160 may be packaged into a controller 164, or may be a standalone unit. In some embodiments needle 100 may be made long enough to connect directly to the source of laser radiation 160. In such case, optica! cable 156 may become redundant. Controller 164 may operate the source of laser radiation 160 in a pulse or continuous radiation mode.

[00024] Controller 164 may further include a facility 168 for adipose tissue laser treatment products removal and a display 172, or a set of buttons providing a user interface and synchronizing operation of said source of laser radiation 160 with facility 168. Controller 164 further includes a temperature feedback loop 176 configured to receive temperature from a temperature sensor (Figure 8) and adapt laser power such as to provide safe tissue treatment. When laser radiation of proper power and wavelength is applied to adipose tissue it liquefies the tissue and, in particular, the fat. The liquefied adipose tissue may be removed or may be left in the body, where it gradually dissipates.. Figure 6 is a schematic illustration of the third exemplary embodiment of a disposable laser radiation conveying needle with liquelied fat removal channels. Figure 6A is a cross section of a disposable needle 100. Needle 100 has a type of jacket 180 implemented as a structure containing a number of liquid conducting channels 184. Jacket 180 may be connected to facility

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Page 5 168, which may be a sland-alone facility or incorporated into controller 164 for liquefied fat and other adipose tissue laser treatment products removal. Suction, provided by a pump (not shown) that is part of facility 168 removes the liquefied tissue. Optical cable 156 (figure 5) may be implemented to have liquid conducting channels 184 in addition to optical fiber or a liquid collecting chamber communicating with a separate liquid conducting channel included in cable 156. 100025| figure 6B illustrates a flexible or rigid needle 186 having a hollow light guide 188. The open end of guide 188, which is introduced into the adipose tissue, is terminated by a sapphire, diamond, or YACj window 190. Similar to needle of figure 6Λ, needle 186 has channels 184 for liquefied fat and other adipose tissue laser treatment products removal.

[00026] figure 6C is an illustration of a needle 202, the body 204 of which is a sapphire. Such needle is more resistant than plastic or glass needles to deposition of carbonized laser treatment products onto it. Needle 202 may have a jacket (not shown) with liquid conducting channels. Alternatively, the jacket may be made of porous material with a suitable degree of porosity.

[00027] figure 7 is a schematic illustration of the method of tissue treatment with the apparatus of the present disclosure, for adipose tissue 210 treatment, needle 100 or any other needle described above is connected by its second end 1 12 to a source of laser radiation 160 located in controller 164. first end 108 of needle 100 pierces the subject skin or tissue 210 and enables insertion of needle 100 into a target volume 218 of adipose tissue 210 to be treated. Controller 164 operates laser source 160 to irradiate target volume 218 of adipose tissue 210. Radiation provided by one or more laser sources 160 liquefies at least a section of adipose tissue 210 adjacent to the first end 108 of needle 100. Controller 164 operates adipose tissue laser treatment products removal facility 168 that removes liquefied fat simultaneously with laser source 160. [00028( In order to facilitate the process of tissue melting location observation an additional second laser, visible through skin/tissue laser such as a l leNe laser, may be coupled to the needle or cable 156. This laser, which is visible through skin, may assist the treatment provider in repositioning first end 108 of needle 100. In an alternative embodiment, a temperature sensitive cream, or a temperature sensitive liquid crystal paste, or a liquid crystal Him may be spread on the tissue over the treated adipose tissue section. The paste/cream and the Him may be such as

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Chromazone ink commercially available from Liquid Crystal Resourees/Hallerest, Inc. Glenview IL 60026 U.S.A. Needle 100 may be disposed of upon completion of treatment. 100029] Figure 8 is a schematic illustration of the fourth exemplary embodiment of a disposable laser radiation conveying needle. Needle 230 is similar to any of the above described needles. It connects to a handle 240 which, with the help of optical cable 244, connects to controller 164. A temperature sensor 248 is mounted on a cantilever 252 configured to follow the first end 256 of needle 230 and measure the temperature of the tissue surface 262. Sensor 248 measures the temperature on the surface of the skin/tissue, and indicates or cuts off the laser power when the treatment should be discontinued to avoid damage to the tissue surface 262. Temperature sensor 248 may be a contact sensor, being in contact with skin 262 or a non-contact sensor. During the treatment, the provider moves handle 240 back and forth, as shown by arrow 242 within tissue 264. Temperature sensor 248 follows laser radiation emitting first end 256 of needle 230 and provides tissue/skin 262 temperature reading to controller 164 controlling the laser power coupled to the treated tissue volume 260. A feedback loop 176 of controller 164 is configured to read the temperature sensor and adapt laser power such as to provide safety tissue treatment. Cantilever 252 with temperature sensor 248 attached to it may be implemented as a part of handle 240 or as a removable and disposable or reusable part.

[00030] As disclosed above, source of laser radiation 160 may contain one or more laser source operating at the same or different wavelength. Accordingly, in an additional embodiment, laser beams from two laser sources with different wavelength could be used to optimize simultaneous adipose tissue (or fat) destruction and blood hemostatis. The laser wavelengths may, for example, be 1,064 micrometer wavelength provided by a NdYAG laser and a 0.9 micrometer wavelength provided by a laser diode. Another suitable set of wavelengths is 1,064 micron and 0.532 micron. Such combination of laser wavelengths reduces bleeding, makes the fat removal procedure safer and shortens the patient recovery time.

[00031] In yet a further embodiment, two lasers guided through the same needle may each operate in different modes of operation, for example, a continuous wave (CW) laser with wavelength of 0.808 micron, 0.980 micron or about 1,500 micron may be

Docket 132-014DI,

Page 7 delivered lo target volume 218 (Figure 7) of adipose tissue to preheat the volume to a desired temperature and liquefy the adipose tissue (fat).

[00032] Following this, or almost simultaneously with, a CW operating laser that heats-up the tissue, a pulsed IR laser, for example a Flo- (Holmium), Tm-(Thulium) or L^Yag (Erbium Yttrium Aluminum Garnet) laser generating pulses in sub-millisecond or millisecond range may be applied to the same target tissue volume 218. During course of the laser pulse, the target tissue (cells and intercellular fluid) near the end 108 of needle 100 changes to overheated (high-pressure) gas forming expanding micro bubbles collapsing at the end of the pulse. Mechanical stress developed by the pulsed laser action can increase the rate of membrane adipose cells disruption and release of liquefied fat from the cell. 'This opto-mechanical action of laser radiation makes fat removal/suction more efficient.

[00033] Figure 9 is a schematic illustration of an additional embodiment of an apparatus for laser assisted liposuction employing the present needle. Fiber optics type connector I 16 (figure I, 4, and 5) may be implemented as a T-lype connector 236 where lluid/liquid conducting channels 184 (Figure 6A) connect directly to laser treatment products removal facility 168 via a tube 274. This simplilles cable 156 structure that contains a light guide only. 100034] The apparatus disclosed above may also be used for skin tightening. The needle is inserted subcutaneously into a treatment recipient so that the first end of the fiber is introduced within the tissue underlying the dermis. Laser source emits radiation of appropriate power conveyed by the needle to the dermis, where the radiation causes collagen destruction and shrinkage within the treatment area.

[00035] The above described disposable needle enables continuous adipose tissue treatment process obviating the need for frequent needle removal, cleaning, and cleaving. This significantly reduces the treatment time, makes the subject treatment more comfortable and simplilles the process.

[00036] While the exemplary embodiments of the disposable needle and the method of using it have been illustrated and described, it will be appreciated that various changes can be made therein without affecting the spirit and scope of the needle and the method of using it. The scope of the needle and the method of using it, therefore, are defined by reference to the following claims:

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