WO2012006533A1 - Method and apparatus for minimally invasive, treatment of human adipose tissue using controlled cooling and radiofrequency current - Google Patents

Method and apparatus for minimally invasive, treatment of human adipose tissue using controlled cooling and radiofrequency current Download PDF

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Publication number
WO2012006533A1
WO2012006533A1 PCT/US2011/043373 US2011043373W WO2012006533A1 WO 2012006533 A1 WO2012006533 A1 WO 2012006533A1 US 2011043373 W US2011043373 W US 2011043373W WO 2012006533 A1 WO2012006533 A1 WO 2012006533A1
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Prior art keywords
cooling
heating
tissue
adipose tissue
treatment
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PCT/US2011/043373
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French (fr)
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Misbah Huzaira Khan
Neil S. Sadick
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Misbah Huzaira Khan
Sadick Neil S
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Publication of WO2012006533A1 publication Critical patent/WO2012006533A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/203—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B18/0218—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A61B2018/00458—Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
    • A61B2018/00464—Subcutaneous fat, e.g. liposuction, lipolysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00994—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B2018/1807—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using light other than laser radiation

Definitions

  • the present invention relates to methods for use in selective destruction and/or disruption of lipid-rich cells by minimally invasive controlled cooling and adjacent skin tightening by using radiofrequency probes, simultaneously.
  • Other aspects of the invention relate to monitoring, detecting, influencing or acting upon conditions arising or otherwise present prior to, during and following the selective disruption/destruction and skin tightening methods.
  • Cellulite is an architectural disorder that most commonly affects approximately 98% of women of reproductive age group. It is characterized by padded and nodular appearance of the skin on poserolateral thighs and buttocks. Fundamental knowledge regarding its pathophysiology is lacking. Hypodermal septae that connect the hypodermis to the underlying fascia and muscular layer are weaker, thinner and significantly reduced in number in women with cellulite than unaffected individuals. Additionally, they are oriented in a perpendicular manner rather than at an oblique angle as seen in men and unaffected females. The lack of strength and a rather perpendicular orientation allows the subcutaneous fat to herniate thru the spetae and appear closer to the skin surface Khan et al. (2010) JAAD; 62(3):361-386, the contents of which are incorporated herein and attached hereto as Appendix A and B.
  • the subcutaneous tissue of the newborns is unusually sensitive to cold.
  • the intracellular lipid content is rich in saturated fatty acids (FA), even moderately cold temperatures can adversely affect the lipid rich cells and can cause cell necrosis.
  • FFA saturated fatty acids
  • This condition is also referred to as "cold panniculitis” and has been reported to cause painful skin lesions; Bondei, Edward E. and Lazarus Gerald S. (1993) disorders of subcutaneous fat (cold panniculitis).
  • the lipid content and the type varies in different subcutaneous tissues.
  • the subcutaneous tissue in the buttock area is richer in monunsaturated fatty acids (only 32% saturated FA) as compared to abdominal area which comprises of 35% of saturated FA.
  • monunsaturated fatty acids only 32% saturated FA
  • abdominal area which comprises of 35% of saturated FA.
  • the abdominal adispose tissue exists in semisolid state due to its higher fat composition while the adipocytes in the buttock area are in liquid state due to higher monounsaturated FA.
  • the epidermal, dermal, vascular and adventitial cells contain very little lipids.
  • cooling is used as epidermal protection rather than as a significant component for damaging the target tissue.
  • Most references utilize cooling only to prevent damage to surrounding tissue in selected treatment areas.
  • a method and device for treatment of cellulite adipose tissue by selectively cooling the adipocytes and subsequently strengthening the hypodermal septae by selectively heating the connective tissue leading to collagen remodeling and collagen stimulation is disclosed. Reduction of cellulite adipose tissue and strengthening of the septae decreases skin nodularity, dimpling and improves skin texture as well.
  • the inventive method and appartus offers a treatment of cellulite without any damage to the surrounding vital structures such as epidermis, dermis, vasculature and underlying muscles.
  • a method is disclosed to selectively damage the lipid rich cells by achieving colder temperatures in a well-controlled manner in order to cause intracellular lipid crystallization leading to adipocyte necrosis, in a minimally-invasive fashion.
  • Selective destruction/disruption of lipi-rich cells results in localized crystalization of highly saturated FA upon cooling at temperatures that do not induce crystalization of highly saturated FA in non-lipid rich cells, causing necrosis.
  • the damage in non-lipid rich cells can be avoided at temperatures that induce crystal formation in lipid-rich cells. Temperature ranges from about -IOC to about IOC can cause most of the intracellular FA to crystalize. However, depending on the body site, one skilled in the art of using the device should be able to adjust the temperature range to about -50C to about 20C based on the lipid content of the target area. Without being
  • Methods of the invention further comprise the application of mechanical force, such as vibration at a frequency of about 5Hz to about 200 Hz.
  • the adipose tissue temperature is decreased, utilizing at least one feedback device to provide feedback information sufficient to confirm that desired temperatures have been achieved.
  • the feedback devices allows the distruction of the adipose tissue without damaging the surrounding non-lipid structures such as vasculature, dermal and epidermal cells.
  • a method to selectively heat selectd target tissue using either unipolar and/or bipolar radiofrequency device comprises subcutaneous fibrous septae and connective tissue beneath the epidermis and dermis above the muscular layer.
  • the device according to the disclosure consists of a grounding pad, a single or plurality of electrodes, a thin treatment probe or a cannula that is inserted into the subcutaneous tissue either seperately or is incorporated into the probe or cannula used for selective controlled cooling of the subcutaneous adipose tissue. Electrical energy is applied directly to the target tissue via the electrode probe (s) and the flow of electric current is controlled such that the target tissue is selectively heated.
  • the method described herein is targeted towards treatment of cellulite the concept is unique and can be employed to treat localized adiposities anywhere in the body.
  • the method is minimally invasive, requiring only about 2- 3 mm access to the subcutaneous tissue for penetration of a single treatment probe which can selectively cause skin tightening using radiofrequency and subsequently selectively cooling the adipocytes in order to induce cell necrosis.
  • All of the treatment apparatus according to the invention is equipped with a
  • the device according to the disclosure combines selective heating of connective tissue with selective controlled cooling of the adipocytes with direct feedback.
  • the device according to the disclosure is a single unit, having an attached, one time use cannula/probe with a size approximately 500 micrometers up to about 4-mm diameter available in various lengths ranging from about 10 cm up to about 30 cm in length.
  • the cannula/probe is directly connected to a cooling system that maintains the appropriate selected temperature of the probe constant through out the procedure.
  • the probe is also equipped with a RF device that allows unipolar/bipolar current to flow through the probe that creates an electrical field around the target areas causing selective connective tissue heating.
  • the main unit is also equipped with a grounding plate attached to the distant site away from the target area if a unipolar electrode is used.
  • the main operating unit allows the operator to chose the treatment parameters, regarding the temperature scales, feedback signals (visual vs. auditory) and to control the intensity of the RF current.
  • the RF treatment is performed first followed by selective cooling of the adipose tissue while checking with the feedback system for appropriate signals.
  • the treatment procedure starts from patient selection based on their presentation and the physician's clinical assessment.
  • An ideal patient would be a female in her reproductive years, who is within 10-20 lbs of her ideal body weight with cellulite on her thighs and perhaps buttocks with minor localized adiposities on lower abdomen and /or inner thighs.
  • the target area is anesthetized using the tumescent anesthesia as used in traditional tumescent liposuction. After about 30 minutes of
  • the area is treated with the device according to the disclosure with the one-time use only probe which is inserted thru the same sites as were used for tumescent anesthesia.
  • the area is initially treated with RF unipolar/bipolar current in order to selectively heat the dermal connective tissue and the septae resulting in their contraction and collagen stimulation.
  • the treatment area is then treated with selective cooling of the lipid-rich cells by moving the probe back and forth and in different directions at a pace that causes rapid but appropriate cooling of the cells.
  • the feedback device is used to determine the appropriate temperature decrease that is required and can help guide the physician to adjust the desired temperatures.
  • Certain body sites might also benefit from mechanical stimulation such as vibration during the procedure. This procedure can be utilized as the only procedure for body sculpting or cellulite treatment or it can be combined with traditional liposuction as well.
  • the cannula/probe according to the disclosure can be fabricated from polymeric material, metals, ceramic, crystals or mixtures thereof. Its structure can be of a singular probe like construction or expandable into an array of multiple probes.
  • the cannula is treated with antimicrobial coatings to prevent infection of the treatment site.
  • the cannula is coated with a lubricious coating to ease its insertion into the treatment area.
  • Other medical coatings know in the art are envisioned within the scope of the invention.
  • the cannula/probe is thermally connected to a cooling system that maintains the appropriate selected temperature of the probe constant through out the procedure.
  • a feedback mechanism monitors and maintains a desired cooling temperature.
  • This cooling may be effected in a number of ways such as through the delivery, as rapidly expanding gas, of known coolants or controlled application of cryogenic liquid in direct contact with the biological tissue at the treatment site in order to maintain the selected portion of the biological tissue at or below a selected temperature range. It is contemplated within the scope of the disclosure that other forms of cooling can be employed such as mechanical heat
  • Different cooling and heating control algorithms can be employed in different combinations of continuous and discontinuous modes of application.
  • Specific control algorithms that can be employed in a control system described herein include proportional (P), proportional-integral (PI) and proportional- integral-derivative algorithms (PID) the like, all well known in the art. These algorithms can use one or more input variables described herein and have their proportional, integral and derivative gains tuned to the specific combination of input variables.
  • Temporal modes of delivery of cooling to treatment tissue include, but are not limited to fixed rate continuous, variable rate continuous, fixed rate pulsed, variable rate pulsed and variable amount pulsing.
  • Example delivery modes include the continuous application of the cooling means in which the flow rate is varied and application of the power source is pulsed or continuous i.e., the application of power can be applied in a pulsed fashion with continuous cooling in which the flow rate of cooling solution is varied as a function of monitoring of tissue interface.
  • Pulsing of the cooling medium flow rate may be either a constant or variable rate.
  • Cooling can also be varied by pulsing the flow rate of continuous cooling, more complicated algorithms involve the use of variable sequences of both cooling and heating.
  • the cannula/probe according to the disclosure is also equipped with a RF device that allows unipolar/bipolar current to flow through the probe that creates an electrical field around the target areas causing selective connective tissue heating.
  • the main unit is also equipped with a grounding plate attached to the distant site away from the target area if a unipolar electrode is used.
  • the main operating unit allows the operator to chose the treatment parameters, regarding the temperature scales, feedback signals (visual vs. auditory) and to control the intensity of the RF current.
  • the RF treatment is
  • 13551536v.l performed first followed by selective cooling of the adipose tissue while checking with the feedback system for appropriate signals.
  • Suitable energy sources for heating and cooling include, but are not limited to, the following: a radio-frequency (RF) source coupled to an RF electrode; a coherent source of light coupled to an optical fiber; an incoherent light source coupled to an optical fiber; a heated fluid coupled to a cannula with a closed channel configured to receive the heated fluid; a heated fluid coupled to a cannula with an open channel configured to receive the heated fluid; a cooled fluid coupled to a cannula with a closed channel configured to receive the cooled fluid; a cooled fluid coupled to a cannula with an open channel configured to receive the cooled fluid; a cryogenic fluid; a resistive heating source, or a fluid jet.
  • RF radio-frequency
  • the power source utilized is an RF source and energy delivery device is one or more RF electrodes also described as electrodes having a surface incorporated into the cannula according to the disclosure.
  • a sensor is positioned within the cannula to monitor temperature, impedance (electrical), cooling media fluid flow, tracking and positioning of the cannula and the like of tissue of one or more of the following: tissue interface, tissue, or electrode.
  • Suitable sensors include impedance, thermal and flow measurement devices. Sensor is used to control the delivery of energy and reduce the risk of cell necrosis at the surface of the skin as well and/or damage to underlying soft tissue structures. Sensor is of conventional design, including but not limited to thermistors, thermocouples, resistive wires, and the like.
  • Suitable flow sensors include ultrasonic, electromagnetic and aneometric (including thin and hot film varieties) as is well known in the art.
  • two or more temperature and impedance sensors are placed on opposite sides or otherwise opposing geometric positions of electrode or cannula.
  • the cannula is equipped with fiber optic component allowing for illumination of the treatment area.
  • the fiber optic component is an extension of imaging component allowing for the capture of images during the treatment procedure.

Abstract

A method and device for treatment of cellulite adipose tissue by selectively cooling the adipocytes and subsequently strengthening the hypodermal septae by selectively heating the connective tissue leading to collagen remodeling and collagen stimulation is disclosed. Reduction of cellulite adipose tissue and strengthening of the septae decrease skin nodularity, dimpling and improves skin texture as well without any damage to the surrounding vital structures such as epidermis, dermis, vasculature and underlying muscles.

Description

METHOD AND APPARATUS FOR MINIMALLY INVASIVE, TREATMENT OF HUMAN ADIPOSE TISSUE USING CONTROLLED COOLING AND RADIOFREQUENCY
CURRENT
FIELD OF INVENTION
The present invention relates to methods for use in selective destruction and/or disruption of lipid-rich cells by minimally invasive controlled cooling and adjacent skin tightening by using radiofrequency probes, simultaneously. Other aspects of the invention relate to monitoring, detecting, influencing or acting upon conditions arising or otherwise present prior to, during and following the selective disruption/destruction and skin tightening methods.
BACKGROUND OF INVENTION
Cellulite is an architectural disorder that most commonly affects approximately 98% of women of reproductive age group. It is characterized by padded and nodular appearance of the skin on poserolateral thighs and buttocks. Fundamental knowledge regarding its pathophysiology is lacking. Hypodermal septae that connect the hypodermis to the underlying fascia and muscular layer are weaker, thinner and significantly reduced in number in women with cellulite than unaffected individuals. Additionally, they are oriented in a perpendicular manner rather than at an oblique angle as seen in men and unaffected females. The lack of strength and a rather perpendicular orientation allows the subcutaneous fat to herniate thru the spetae and appear closer to the skin surface Khan et al. (2010) JAAD; 62(3):361-386, the contents of which are incorporated herein and attached hereto as Appendix A and B.
Hence, the padded and nodular appearance of cellulite is an embarrasment to even the most fit of women. There are numerous treatment options available for fat reduction which have been tried for treatment of cellulite. However, none of the present available modalities have shown to improve cellulite appearance with a certain degree of predictability.
The subcutaneous tissue of the newborns is unusually sensitive to cold. In newborns, the intracellular lipid content is rich in saturated fatty acids (FA), even moderately cold temperatures can adversely affect the lipid rich cells and can cause cell necrosis. This condition is also referred to as "cold panniculitis" and has been reported to cause painful skin lesions; Bondei, Edward E. and Lazarus Gerald S. (1993) disorders of subcutaneous fat (cold panniculitis). In Dermatology in General Medicine (McGraw -Hill, Inc) 1333-1334
In adults however, the lipid content and the type varies in different subcutaneous tissues. For instance, the subcutaneous tissue in the buttock area is richer in monunsaturated fatty acids (only 32% saturated FA) as compared to abdominal area which comprises of 35% of saturated FA. Under room temperature the abdominal adispose tissue exists in semisolid state due to its higher fat composition while the adipocytes in the buttock area are in liquid state due to higher monounsaturated FA. Malcom G. et al., (1989) Am J Clin Nutr. 50(2):288-91. The epidermal, dermal, vascular and adventitial cells contain very little lipids.
Cycles of cooling and heating for treatment of tissue are described in 5,814,040 (Candela's "dynamic cooling") ('040 patent). Unfortunately, the devcies and procedures disclsoure do not utilze Radio Frequncey (RF), and are therefore not for treatment of cellulite, cooling is applied only to the epidermis, and cooling doesn't provide the treatment. The method described in the Ό40 patent suffers from a one dimensional approach to treatment.
Generally, cooling is used as epidermal protection rather than as a significant component for damaging the target tissue. Most references utilize cooling only to prevent damage to surrounding tissue in selected treatment areas.
A number of references discuss using RF delivered from the surface or from a needle array and add cooling to counteract the effects of excessive damage to the epidermis. These disclosures do not result in a synergistic treatment effect. Most of the prior art is for skin tightening or skin rejuvenation applications rather
2
13551536v.l than for cellulite treatment.
Currently available non-invasive body contouring treatment modalities have shown some success with treatment of localized adiposities but have failed to demonstrate any efficacy in the treatment of cellulite adipose tissue. This is in part because cellulite has a multifactorial etiology. In addition to excess herniated fat, there is also a component of weak hypodermal junction. Clearly a method is need to target all aspects of cellulite etiology.
SUMMARY OF INVENTION
According to the disclosure, a method and device for treatment of cellulite adipose tissue by selectively cooling the adipocytes and subsequently strengthening the hypodermal septae by selectively heating the connective tissue leading to collagen remodeling and collagen stimulation is disclosed. Reduction of cellulite adipose tissue and strengthening of the septae decreases skin nodularity, dimpling and improves skin texture as well. The inventive method and appartus offers a treatment of cellulite without any damage to the surrounding vital structures such as epidermis, dermis, vasculature and underlying muscles.
In one aspect of the invention a method is disclosed to selectively damage the lipid rich cells by achieving colder temperatures in a well-controlled manner in order to cause intracellular lipid crystallization leading to adipocyte necrosis, in a minimally-invasive fashion. Selective destruction/disruption of lipi-rich cells results in localized crystalization of highly saturated FA upon cooling at temperatures that do not induce crystalization of highly saturated FA in non-lipid rich cells, causing necrosis.
According to the dislcosure, the damage in non-lipid rich cells can be avoided at temperatures that induce crystal formation in lipid-rich cells. Temperature ranges from about -IOC to about IOC can cause most of the intracellular FA to crystalize. However, depending on the body site, one skilled in the art of using the device should be able to adjust the temperature range to about -50C to about 20C based on the lipid content of the target area. Without being
3
13551536v.l bound to any particular theory, it is thought that cooling induces metabolism, (i.e., lipolysis which further enhances the reduction of lipid-rich cells).
According to the disclosure the effects of cooling on cell destruction can be further enhanced by simultaneous mechanical stimulation. Methods of the invention further comprise the application of mechanical force, such as vibration at a frequency of about 5Hz to about 200 Hz.
According to a further aspect of the disclosure, the adipose tissue temperature is decreased, utilizing at least one feedback device to provide feedback information sufficient to confirm that desired temperatures have been achieved. The feedback devices allows the distruction of the adipose tissue without damaging the surrounding non-lipid structures such as vasculature, dermal and epidermal cells.
According to still a further aspect of the invention, there is provided a method to selectively heat selectd target tissue using either unipolar and/or bipolar radiofrequency device. The selected target tissue comprises subcutaneous fibrous septae and connective tissue beneath the epidermis and dermis above the muscular layer. The device according to the disclosure consists of a grounding pad, a single or plurality of electrodes, a thin treatment probe or a cannula that is inserted into the subcutaneous tissue either seperately or is incorporated into the probe or cannula used for selective controlled cooling of the subcutaneous adipose tissue. Electrical energy is applied directly to the target tissue via the electrode probe (s) and the flow of electric current is controlled such that the target tissue is selectively heated.
Although the method described herein is targeted towards treatment of cellulite the concept is unique and can be employed to treat localized adiposities anywhere in the body. The method is minimally invasive, requiring only about 2- 3 mm access to the subcutaneous tissue for penetration of a single treatment probe which can selectively cause skin tightening using radiofrequency and subsequently selectively cooling the adipocytes in order to induce cell necrosis. All of the treatment apparatus according to the invention is equipped with a
4
13551536v.l feedback device in order to provide optimum temperature control in a minimally- invasive way.
In a further aspect of the invention the device according to the disclosure combines selective heating of connective tissue with selective controlled cooling of the adipocytes with direct feedback.
In yet a further aspect of the invention the device according to the disclosure is a single unit, having an attached, one time use cannula/probe with a size approximately 500 micrometers up to about 4-mm diameter available in various lengths ranging from about 10 cm up to about 30 cm in length. The cannula/probe is directly connected to a cooling system that maintains the appropriate selected temperature of the probe constant through out the procedure. Additionally, the probe is also equipped with a RF device that allows unipolar/bipolar current to flow through the probe that creates an electrical field around the target areas causing selective connective tissue heating. The main unit is also equipped with a grounding plate attached to the distant site away from the target area if a unipolar electrode is used. The main operating unit allows the operator to chose the treatment parameters, regarding the temperature scales, feedback signals (visual vs. auditory) and to control the intensity of the RF current. According to the disclosure the RF treatment is performed first followed by selective cooling of the adipose tissue while checking with the feedback system for appropriate signals.
DETAILED DESCRIPTION OF THE INVENTION
According to the disclosure the treatment procedure starts from patient selection based on their presentation and the physician's clinical assessment. An ideal patient would be a female in her reproductive years, who is within 10-20 lbs of her ideal body weight with cellulite on her thighs and perhaps buttocks with minor localized adiposities on lower abdomen and /or inner thighs. After obtaining a sterile skin surface, the target area is anesthetized using the tumescent anesthesia as used in traditional tumescent liposuction. After about 30 minutes of
5
13551536v.l incubation period, the area is treated with the device according to the disclosure with the one-time use only probe which is inserted thru the same sites as were used for tumescent anesthesia. The area is initially treated with RF unipolar/bipolar current in order to selectively heat the dermal connective tissue and the septae resulting in their contraction and collagen stimulation.
The treatment area is then treated with selective cooling of the lipid-rich cells by moving the probe back and forth and in different directions at a pace that causes rapid but appropriate cooling of the cells. The feedback device is used to determine the appropriate temperature decrease that is required and can help guide the physician to adjust the desired temperatures. Certain body sites might also benefit from mechanical stimulation such as vibration during the procedure. This procedure can be utilized as the only procedure for body sculpting or cellulite treatment or it can be combined with traditional liposuction as well.
The cannula/probe according to the disclosure can be fabricated from polymeric material, metals, ceramic, crystals or mixtures thereof. Its structure can be of a singular probe like construction or expandable into an array of multiple probes. In one illustrative embodiment the cannula is treated with antimicrobial coatings to prevent infection of the treatment site. In a further illustrative embodiment the cannula is coated with a lubricious coating to ease its insertion into the treatment area. Other medical coatings know in the art are envisioned within the scope of the invention.
The cannula/probe is thermally connected to a cooling system that maintains the appropriate selected temperature of the probe constant through out the procedure. A feedback mechanism monitors and maintains a desired cooling temperature. This cooling may be effected in a number of ways such as through the delivery, as rapidly expanding gas, of known coolants or controlled application of cryogenic liquid in direct contact with the biological tissue at the treatment site in order to maintain the selected portion of the biological tissue at or below a selected temperature range. It is contemplated within the scope of the disclosure that other forms of cooling can be employed such as mechanical heat
6
13551536v.l pumps, circulated cooled liquids, refrigeration devices or the like.
Different cooling and heating control algorithms can be employed in different combinations of continuous and discontinuous modes of application. Specific control algorithms that can be employed in a control system described herein include proportional (P), proportional-integral (PI) and proportional- integral-derivative algorithms (PID) the like, all well known in the art. These algorithms can use one or more input variables described herein and have their proportional, integral and derivative gains tuned to the specific combination of input variables. Temporal modes of delivery of cooling to treatment tissue include, but are not limited to fixed rate continuous, variable rate continuous, fixed rate pulsed, variable rate pulsed and variable amount pulsing. Example delivery modes include the continuous application of the cooling means in which the flow rate is varied and application of the power source is pulsed or continuous i.e., the application of power can be applied in a pulsed fashion with continuous cooling in which the flow rate of cooling solution is varied as a function of monitoring of tissue interface. Pulsing of the cooling medium flow rate may be either a constant or variable rate.
Even the amount of a single pulse of the cooling medium can be varied (variable amount pulsing). Any liquid, such as a cryogen (e.g. liquid nitrogen) that quickly evaporates with heat, can be applied in this fashion. Cooling can also be varied by pulsing the flow rate of continuous cooling, more complicated algorithms involve the use of variable sequences of both cooling and heating.
The cannula/probe according to the disclosure is also equipped with a RF device that allows unipolar/bipolar current to flow through the probe that creates an electrical field around the target areas causing selective connective tissue heating. The main unit is also equipped with a grounding plate attached to the distant site away from the target area if a unipolar electrode is used. The main operating unit allows the operator to chose the treatment parameters, regarding the temperature scales, feedback signals (visual vs. auditory) and to control the intensity of the RF current. According to the disclosure the RF treatment is
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13551536v.l performed first followed by selective cooling of the adipose tissue while checking with the feedback system for appropriate signals.
Suitable energy sources for heating and cooling that may be employed in one or more embodiments of the invention include, but are not limited to, the following: a radio-frequency (RF) source coupled to an RF electrode; a coherent source of light coupled to an optical fiber; an incoherent light source coupled to an optical fiber; a heated fluid coupled to a cannula with a closed channel configured to receive the heated fluid; a heated fluid coupled to a cannula with an open channel configured to receive the heated fluid; a cooled fluid coupled to a cannula with a closed channel configured to receive the cooled fluid; a cooled fluid coupled to a cannula with an open channel configured to receive the cooled fluid; a cryogenic fluid; a resistive heating source, or a fluid jet.
In one illustrative embodiment according to the disclosure, the power source utilized is an RF source and energy delivery device is one or more RF electrodes also described as electrodes having a surface incorporated into the cannula according to the disclosure.
A sensor is positioned within the cannula to monitor temperature, impedance (electrical), cooling media fluid flow, tracking and positioning of the cannula and the like of tissue of one or more of the following: tissue interface, tissue, or electrode. Suitable sensors include impedance, thermal and flow measurement devices. Sensor is used to control the delivery of energy and reduce the risk of cell necrosis at the surface of the skin as well and/or damage to underlying soft tissue structures. Sensor is of conventional design, including but not limited to thermistors, thermocouples, resistive wires, and the like. Suitable flow sensors include ultrasonic, electromagnetic and aneometric (including thin and hot film varieties) as is well known in the art. In various embodiments, two or more temperature and impedance sensors are placed on opposite sides or otherwise opposing geometric positions of electrode or cannula.
According to one illustrative embodiment the cannula is equipped with fiber optic component allowing for illumination of the treatment area. In a further
8
13551536v.l illustrative embodiment the fiber optic component is an extension of imaging component allowing for the capture of images during the treatment procedure.
Although the present invention has been described in the context of cellulite removal, it must be specifically understood that the use of the methods according to the disclosure can also be directly applied to many different applications in the field of dermatology, such as body sculpting, localized removal of fatty tissue and ablation of solid tumors of certain origin. The methodology and apparatus can be applied in any case where it is important to maintain a low temperature to destroy selected tissues having a high FA content, while heating or thermally impacting other target tissues.
Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiments has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following claims.
Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. The claims are thus to be understood to include what is specifically illustrated and described above, what can be obviously substituted and also what essentially incorporates the essential idea of the invention.
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13551536v.l

Claims

We claim:
1. A method for the treatment of biological tissues comprising:
cooling a selected portion of said subcutaneous adipose tissue for a first time period to establish a selected temperature gradient through said subcutaneous adipose tissue so that substantially only said selected portion of said subcutaneous adipose tissue is cooled by a predetermined minimum temperature drop; and
heating target tissue using either unipolar and/or bipolar radiofrequency device, wherein the target tissue comprises subcutaneous fibrous septae and connective tissue beneath the epidermis and dermis and above the muscular layer.
2. The method according to claim 1, wherein said cooling of said subcutaneous adipose tissue is from about -50° C to about 20° C.
3. The method according to claim 1, wherein said cooling of said subcutaneous adipose tissue is from about -10° C to about 10° C.
4. The method according to claim 1 further comprising the step of applying vibration to said cooled tissue.
5. The method according to claim 4, wherein said vibration is applied at a frequency of about 5Hz to about 200 Hz.
6. The method according to claim 1, wherein said heating of said target tissue is achieved using an unipolar radiofrequency device.
7. The method according to claim 1, wherein said heating of said target tissue is achieved using a bipolar radiofrequency device.
8. The method according to claim 1, wherein said cooling is delivered in a continuous fixed rate.
10
13551536v.l
9. The method according to claim I, wherein said cooling is delivered in a continous variable rate.
10. The method according to claim 1 , wherein said cooling is delivered in a pulsed fixed rate.
11. The method according to claim 1, wherein said cooling is delivered in a pulsed variable rate.
12. The method according to claim 1, wherein said cooling is delivered in a pulsing variable amount.
13. The method according to claim 1, wherein said heating is achieved with radio frequency.
14. The method according to claim 1, wherein said cooling is achieved with a liquid cryogen.
15. The method according to claim 1, wherein said heating is achieved with a radio-frequency ( F) source coupled to an RF electrode.
16. The method according to claim 1, wherein said heating is achieved with a coherent source of light coupled to an optical fiber or an incoherent light source coupled to an optical fiber.
17. The method according to claim 1, wherein said heating is achieved with a heated fluid coupled to a cannula with a closed channel configured to receive the heated fluid.
18. The method according to claim 1, wherein said heating is achieved
11
13551536v.l with a heated fluid coupled to a cannula with an open channel configured to receive the heated fluid.
19. The method according to claim I, wherein said cooling is achieved by a cooled fluid coupled to a cannula with a closed channel configured to receive the cooled fluid.
20. The method according to claim I, wherein said cooling is achieved by a cooled fluid coupled to a cannula with an open channel configured to receive the cooled fluid.
21. The method according to claim 1 wherein said heating is achieved with a resistive heating source.
22. A method for the treatment of biological tissues comprising:
cooling a selected portion of said subcutaneous adipose tissue to a predetermined temperature to establish a selected temperature gradient through said subcutaneous adipose tissue; and
heating target tissue using a radiofrequency device, wherein the target tissue comprises subcutaneous fibrous septae and connective tissue.
12
13551536v.l
PCT/US2011/043373 2010-07-08 2011-07-08 Method and apparatus for minimally invasive, treatment of human adipose tissue using controlled cooling and radiofrequency current WO2012006533A1 (en)

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US9089361B2 (en) 2007-04-30 2015-07-28 Andrew Technologies, Llc Liposuction based on tissue liquefaction
US9764145B2 (en) 2009-05-28 2017-09-19 Angiodynamics, Inc. System and method for synchronizing energy delivery to the cardiac rhythm
US9888956B2 (en) 2013-01-22 2018-02-13 Angiodynamics, Inc. Integrated pump and generator device and method of use
US9895189B2 (en) 2009-06-19 2018-02-20 Angiodynamics, Inc. Methods of sterilization and treating infection using irreversible electroporation
US10463426B2 (en) 2001-08-13 2019-11-05 Angiodynamics, Inc. Method for treating a tubular anatomical structure
US10660691B2 (en) 2015-10-07 2020-05-26 Angiodynamics, Inc. Multiple use subassembly with integrated fluid delivery system for use with single or dual-lumen peristaltic tubing
US11723710B2 (en) 2016-11-17 2023-08-15 Angiodynamics, Inc. Techniques for irreversible electroporation using a single-pole tine-style internal device communicating with an external surface electrode
US11779395B2 (en) 2011-09-28 2023-10-10 Angiodynamics, Inc. Multiple treatment zone ablation probe
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US10463426B2 (en) 2001-08-13 2019-11-05 Angiodynamics, Inc. Method for treating a tubular anatomical structure
US9089361B2 (en) 2007-04-30 2015-07-28 Andrew Technologies, Llc Liposuction based on tissue liquefaction
US9764145B2 (en) 2009-05-28 2017-09-19 Angiodynamics, Inc. System and method for synchronizing energy delivery to the cardiac rhythm
US11707629B2 (en) 2009-05-28 2023-07-25 Angiodynamics, Inc. System and method for synchronizing energy delivery to the cardiac rhythm
US9895189B2 (en) 2009-06-19 2018-02-20 Angiodynamics, Inc. Methods of sterilization and treating infection using irreversible electroporation
US11931096B2 (en) 2010-10-13 2024-03-19 Angiodynamics, Inc. System and method for electrically ablating tissue of a patient
US11779395B2 (en) 2011-09-28 2023-10-10 Angiodynamics, Inc. Multiple treatment zone ablation probe
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US11957405B2 (en) 2013-06-13 2024-04-16 Angiodynamics, Inc. Methods of sterilization and treating infection using irreversible electroporation
US10660691B2 (en) 2015-10-07 2020-05-26 Angiodynamics, Inc. Multiple use subassembly with integrated fluid delivery system for use with single or dual-lumen peristaltic tubing
US11723710B2 (en) 2016-11-17 2023-08-15 Angiodynamics, Inc. Techniques for irreversible electroporation using a single-pole tine-style internal device communicating with an external surface electrode

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