METHOD AND APPARATUS FOR USE OF ICE CRYSTALS IN AESTHETIC AND COSMETIC PROCEDURES
20180310979 ยท 2018-11-01
Inventors
Cpc classification
A61B2018/0047
HUMAN NECESSITIES
A61M37/00
HUMAN NECESSITIES
A61M35/00
HUMAN NECESSITIES
International classification
Abstract
A device combines skin tissue cooling and microdermabrasion and includes: a source of ice crystals; a mechanism for propelling the ice crystals at a plurality of velocities; a controller, the controller being programmable to increase or decrease the velocity of the propelled ice crystals; the controller controls the velocity of the ice crystals to range from low speed to impinge upon and cool the skin tissue to a higher velocity to cause microdermabrasion of the skin tissue.
Claims
1. A device which combines skin tissue cooling and microdermabrasion comprising: a source of ice crystals; a mechanism for propelling the ice crystals at a plurality of velocities; a controller, the controller being programmable to increase or decrease the velocity of the propelled ice crystals; wherein the controller controls the velocity of the ice crystals to range from low speed to impinge upon and cool the skin tissue to a higher velocity to cause microdermabrasion of the skin tissue.
2. The device for treatment of skin tissue of claim 1 comprising: the mechanism for further one or more of: (a) sizing and shaping the ice crystals, and (b) fractionating the ice crystals delivery; wherein the ice crystals are propelled, under the control of the controller, to impinge on the skin tissue surface in a spaced-apart, fractionated pattern.
3. The device of claim 2, wherein the controller controls the mechanism for propelling the velocity of the ice crystals impinging on the skin tissue with sufficient velocity to penetrate the skin tissue surface.
4. A device for the treatment of skin tissue comprising: a source or ice crystals; a mechanism for propelling the ice crystals; a controller; a source of electromagnetic energy in the vicinity of the mechanism for propelling the ice crystals; wherein the controller controls: (a) the mechanism for propelling the ice crystals and (b) the source of electromagnetic energy; wherein the controller causes the mechanism to propel ice crystals at the skin tissue one of before, during or after the source of electromagnetic energy is activated by the controller to impinge electromagnetic energy towards the skin tissue.
5. The device of claim 4, wherein the source of electromagnetic energy is one or more of: laser energy, RF energy and ultrasonic energy.
6. The device of claim 5, wherein the source of electromagnetic energy is fractionated energy.
7. A device for the treatment of tissue comprising: one or more hollow needles; a source of ice crystals, the ice crystals being sized to fit within the one or more hollow needles; a controller; a mechanism for propelling the ice crystals through the one or more hollow tubes; wherein the controller causes the mechanism to propel the ice crystals through the one or more hollow needles, out the distal end of the one or more needles and into the tissue.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
DETAILED DESCRIPTION OF THE PRESENT INVENTION
Removal of the Stratum Corneum (SC)
[0024] The stratum corneum is the upper layer of the skin that contains 15-20 layers of dead cells. The thickness of the stratum corneum varies between 10-40 m depending on the person and in which place on the body it is located. The main function of the stratum corneum is to protect the deeper layers of the skin from injuries and bacterial invasion. However, the stratum corneum is likewise considered a strong barrier to the diffusion of any compounds and drugs through the lower skin layers.
[0025] The stratum corneum, as a dry layer of dead cells has a different characteristic than the living tissue underneath. In certain procedures, there is a need to remove the stratum corneum in order to improve the energy coupling of skin tissue with an energy source. For example, RF or Ultrasound may be coupled more efficiently to living tissue (which contains high percentage of water) than it can be coupled to the SC. Therefore, in order to overcome coupling problems with the SC, some devices operate by increasing the energy provided in order to penetrate or ablate the SC; some other devices attempt to improve the coupling with a coupling material such as an ultrasound gel. According to an embodiment of the present invention, an ice blasting device is disclosed which is configured to remove the SC from the skin in order to expose the living skin. The exposed living skin may be further treated by energy based treatments such as light, RF or US with lower energies should the SC were still in place.
[0026] Moreover, the effect of blasting the SC with ice particles will simultaneously reduce the temperature of the exposed tissue and some depth below the exposed tissue. Therefore, another aspect of the invention is removing the SC and simultaneously reducing temperature of the tissue. The energy of the ice particles according to some aspects of this invention, as will be described below, can be controlled so that different tissue effects may be achieved. A non-blasting cooling treatment profile may also be achieved and may allow the cooling of the skin for a period of time without causing any blasting or skin peeling effect. This mode of the operation may keep the skin at a certain temperature range as needed for a required period of time. This can be achieved by a using free-hand paint brush mode handpiece which allows a physician to keep a tissue region in the desired temperature range or through use of a scanner device which may automatically scan one more nozzles which are configured to blow a stream of ice particles.
[0027] A thermal imaging system may also be used according to another aspect of the invention in order to monitor the tissue temperature online and feedback to the physician information on the scanner (such as to the speed of scanning), the ice particle size or distribution of sizes, the kinetic energy of the ice particles or the distribution of the kinetic energy of ice particles, the direction of blowing, and more. Such a thermal image may be captured through a thermal camera or a CCD device which has some sensitivity in the infrared region. A combined visual image and thermal image may be produced on a monitor or in a special glasses worn by the physician.
[0028] Mixed particle populations having different characteristics or applied with different energy profile may provide a combined treatment of blasting and non-blasting effects on the skin simultaneously or interchangeably. The switch from one mode of operation to another mode of operation may be gradual so that the blasting effect is enhanced at the beginning when the SC is still in place and then slowly decreased until it stops when the SC has been removed and a prolonged cooling period is required.
[0029] For an application of fat removal, it is known in the prior art that cooling the fat layer to a temperature of 10 C. to +10 C. may cause the fat cells to crystallize or even create an apoptosis process. Therefore, according to this aspect of the invention, a system may be configured to manually or automatically expose a skin region, with or without a SC, to a blasting or non-blasting cooling profile using a beam of kinetically energized ice particles so that fat layer below such skin region may be maintained in a temperature range of 10 C. to +10 C. for a period of time of 1 sec to 1 hour.
[0030] Different handpieces 10 and 200, scanner 210 and nozzle shapes 20 can be provided, such as a manual pen-like handpiece having a single nozzle or an array of nozzles configured to increase the flow of an ice crystal beam 30, 30a, 30b, its spot size 40, or to mix particles beams or populations, as shown in
[0031] According to another aspect of the invention, as can be seen in
[0032] According to another aspect of the invention, as can be seen in
[0033] As known to those skilled in the art, there are a number of fractional lasers which may be used in accordance with this invention. Once such a laser may be a CO2 laser which is one of the common lasers in the industry. It is also known that dry ice sublimes and does so when it impinges the skin tissue rather than melting on the skin tissue. According to the combined laser ice treatment aspect of the invention mentioned above, there is a need to ensure that the laser energy is not absorbed in the ice particles or their vapors so that the optical energy can create the required tissue effect. Therefore, according to this aspect of the invention, in order to reduce the amount of laser energy absorbed in the CO2 gas which is vaporized from the dry ice particles the CO2 laser, it may be possible to use an isotopic CO2 laser using isotopic carbon (.sup.13C) in order to provide a wavelength of 11.2 micron instead of the standard CO2 laser wavelength of 10.6 micron. This will likely reduce the blooming effect of high absorption of the 10.6 micron laser in a CO2 gas environment.
Dermabrasion Procedures
[0034] This is a known technique, and is used to remove and peel away skin layers until sufficient skin tissue wounding is achieved. The skin then starts a process of healing and grows a new layer of tight skin. Presently, such dermabrasion is performed using chemical peels as well as mechanical removal of the skin and often requires anesthetics to be delivered to reduce the pain that is experienced by the patient. However, dermabrasion can be provided using ice crystals impinging the skin. By changing the speed and size (or shape) and density of the ice crystals or pellets, deeper skin layers may be reached to cause the desired wounding. As with the stratum corneum removal discussed above, providing the treatment using ice crystals can provide skin cooling and pain reduction. As well, the ice crystals may not be pure CO2, but may be combined, when being formed, with medicines cosmetics, skin nutrition elements such as vitamins and minerals, nanoparticles such as Silver, Gold, Titanium dioxide, Zinc oxide, Quantum dots or Carbon based nanoparticles, or anesthetic substances to reduce pain and promote wound healing among other beneficial effects.
[0035] According to another aspect of the invention, as mentioned above, while the dry ice particles peel the upper layers of the skin, the remaining exposed skin portion is cooled and so are layers underneath. The cooled skin has reduced elasticity and it becomes more brittle. Therefore, the mechanical effect of the ice particles in terms of pealing is increased. According to another aspect, cold analgesic is provided to a treated tissue by the ice crystals to improve patient tolerance to ice or any other energy based treatment mentioned in this application.
[0036] Furthermore, the ice pellets that are fired towards the skin would touch the outer layer in a discontinuous manner and would bounce off the skin. This will allow the cooling of the skin layers but would prevent the damage caused by the prolonged physical contact of skin with dry ice. This method can be used for various applications, such as dry cooling of skin layers for pain management and for the selective cooling of the fat skin layers.
Fractional Treatment Using Ice Crystals
[0037] As mentioned above, fractional treatment has been widely used with different energy based devices such as light/RF/US. The fractional treatment goal is to treat a fraction of the skin and generate deep channels of wounds in the skin. The untreated skin layers around the wounded channels will deliver the needed cells and components to start fast wound healing and collagen remodeling for skin tightening.
[0038] The same result can be achieved with ice crystals or pellets as seen in
[0039] According to another embodiment of the present invention, as can be seen in
[0040] The process of treatment may start by creating ice crystals or pellets with a diameter of about 1 to about 50 m. The diameter of the ice crystal or pellet will determine the diameter of the microscopic wounds or microchannels made to and into the skin surface. The ice crystals or pellets may be fired with high-speed at the skin surface using a handpiece with one nozzle or preferably a handpiece like that shown in
[0041] The firing of the ice crystals or pellets will be facilitated by one or more known devices that provide pressurization to give the ice crystals or pellets sufficient speed to penetrate the skin surface and into the skin tissue. The ice crystals or pellets will then enter the skin and start to sublime. The pellet's shape, mass and volume will be reduced and become smaller as it penetrates the skin layers, causing the microchannel to become narrower as the pellet goes deeper into the skin surface.
[0042] The depth of the microchannel may be determined by a number of factors, including the speed of the crystals or pellets and the number of pellets being fired, as more pellets will penetrate the channel and result in deeper wounding. The optimal range of a channel's depth is somewhere between 30 m and increases to as much as 1000 m.
[0043] Another benefit of using ice crystals of pellets is the evaporation of carbon dioxide inside the channels. It has been shown that exposing living cells to carbon dioxide will increase the blood vessel's diameter around the wounds, thereby delivering more oxygen to the treated region. This results in increasing metabolism, stem cells delivery and the necessary components for wound healing and skin revitalization. Cooling is also a side benefit of using ice crystals or pellets. Also, the delivery handle shown in
[0044]
[0045] In
[0046]
[0047] As can be seen in
[0048] According to another aspect, one or more types of nanoparticles may be added to the dry ice particles. Different amounts of nanoparticles may be added to the dry ice particles based on the required density and amount of nanoparticles required to hit the target tissue. According to this aspect of the invention, the dry ice particles may be considered as carriers of the nanoparticles. As a carrier, the ice particles buffer allows a better way to control and propel the nanoparticles in the device on their way to the target tissue. Nanoparticles in the prior art are delivered to the skin as a paste or in the form of liquid droplets. Residual materials are therefore left on the target tissue. As mentioned above, dry ice particles tend to sublime when they hit a target leaving no or less residual material on the target. This allows the nanoparticles to interact directly and freely with an exposed skin (with or without SC). In this direct interaction of separated and free nanoparticles with the skin, nanofractional ablation of the target tissue may be achieved. Based on the amount of nanoparticles per dry ice particle carrier and based on the geometrical and energy profile of the dry ice carrier, it is possible to control the nanofractional effect of the tissue in terms of density of nanochannels, their size and depth. The nanoparticles, therefore, may cause mechanical nanofractional effects due to their mass, speed, density and penetration depth into the tissue. They may cause thermal effects due to the fact that despite their small size and small heat capacitance, they are delivered with a low temperature carrier so that they hit the target tissue while still having a temperature which is lower than the skin temperature, or lower than the room temperature or at about the temperature of the dry ice carrier particle. A third effect of the nanoparticles is based on the nature of the nanoparticle or nanoparticles used. For example, silver or copper nanoparticles may be used to achieve antibacterial effects in a target tissue or wound. Also according to this aspect, a two stage fractional system is described. In a first stage, a dry ice particle carrier is delivered to a target tissue. In a second stage, the dry ice particle hits a target tissue, sublimes and releases one or more nanoparticles to further hit, ablate, penetrate, peel or treat a target tissue. The temperature of the one or more nanoparticles is controlled by the temperature of the dry ice carrier and allows the release of the one or more nanoparticles adjacent a target tissue at a temperature similar to the temperature of the dry ice particle carrier. It should be mentioned that it is difficult and considered unsafe to release a stream of nanoparticles through the air from a reservoir directly to a target tissue without any carrier. Using dry ice particles as a carrier to nanoparticles may overcome these problems.
Deliver of Drug or Other Medicinal Substances
[0049] As mentioned previously, the stratum corneum creates a strong barrier against material and molecule diffusion into the skin layers. Drug delivery into the skin layers can be facilitated with ice crystals or pellets by combining both processes. The drug can be either delivered right after the ice crystal or pellet delivery or simultaneously.
Ice Crystal Treatment for Fat Reduction
[0050] It is known that the fat layer may be reduced by bringing the skin tissue to a range of 2-8 C. The fat droplets will crystalize and will then be removed by macrophages.
[0051] Ice crystals or pellets may be employed for the purpose of reaching the fat layers by loading them with enough high kinetic energy to create channels (as discussed above in the context of fractional treatment). The kinetic energy will be reduced to zero (because of the skin resistance) and the remaining pellet will remain in the channel to cool the area and result in the crystallization of the fat droplets.
[0052] This process can be generalized to not only treat fat droplets but also to facilitate a localized cooling of the treated area without cooling all the skin layer. The advantage of this localized cooling is reduction of pain resulted by cooling the upper skin layers to very low temperatures in order to reach the deeper skin layers.
Use of Ice crystals or Pellets in Wound Debridement
[0053] The chronic wounds market is a wide market waiting for revolutionary processes for debridement of wounds for skin renewal. The employment of propelled ice crystals may be used to remove the affected area with no mechanical or frictional procedures that result in heating the skin. The cold temperature of the ice can be used as a means to manage the pain of peeling away the dead skin. The CO2 absorbed by the tissue may also contribute to the wound healing process, as mentioned above, by signaling the body to increase blood perfusion in the area. This is known as the Bohr effect.
Other Uses of Propelled Ice Crystals or Pellets
[0054] These include: skin whitening, tattoo removal, selective hair removal, and even acne treatment and treatment of hyperhidrosis, as it has been found that sweat glands are very much affected by the temperature. Lower temperatures may reduce or even eliminate secretions from the glands. As mentioned above, a side benefit is cooling of the skin surface during any of the above discussed procedures, as well as the benefits of combining ice crystal or pellet treatments with light/RF/US treatments.
Ice Crystals or Pellets in Brachytherapy-type Applications
[0055] While the above discussed the use of ice crystals or pellets which are propelled into the skin through the use of a sufficiently high energy source, another approach within the scope of the present invention is to adopt technology existing presently for the treatment of, for example, prostate cancer called brachytherapy. This cancer treatment technology involves the provision of one of more hollow needles through which very small pellets of radioactive particles are placed in the prostate. Adapting that technology to fat reduction, small ice crystals or pellets may be propelled deep into the skin tissue after the needles have been inserted into the patient's tissue Existing devices may be adapted and configured to seed ice particles into the fat tissue much as in brachytherapy systems radioactive seeds are placed in a cancers prostate tissue.
[0056] An additional advantage is that the technology already existing in the field of brachytherapy may be adopted to a fat reduction regime, including imaging systems to image a fat region and to control a planned treatment, a 3-D treatment planner to calculate temperature versus time profiles required to body sculpture specific area, determining in which places to seed the ice crystals or pellets and determining what should be the size of the ice crystals or pellet size and distribution. A device, which may be attached to a suitable handpiece, mounts one or more hollow needles to load a series of ice crystals or pellets into the hollow needles for delivery into the skin tissue. In addition, this same device may be utilized not only for the treatment of fat but also the treatment of prostate cancer, as a cryotherapy regime for the treatment of prostate cancer presently exists and is presently used in the treatment of certain types of prostate cancer.
[0057] As brachytherapy is practiced in two modesHDT and LDT, ice brachycooling may also be practiced in similar ways. The equivalent to the HDT mode may be an ice particle loader coupled to an ice particle delivery tube having a rigid needle in its distal end. Ice may be loaded into the ice tube and the needle and inserted into a target tissue. The loader may be configured to move the ice particle along a certain region of the needle, the region inside the target tissue, so that heat is transferred through the needle wall from the target tissue. According to this method of the tissue treatment, no ice is seeded in the tissue. According to the equivalent of the LDT mode, the needles are configured to seed ice particles in the target region.
[0058] As can be seen in
Fat Tumors (Lipoma) Treatment
[0059] A fat tumor, known as a lipoma, is a benign tumor composed of adipose tissue. These lipoma tumors are often small (1 cm) but can sometimes reach a size of 6 cm., the tumor is often visible, movable, but painless. Due to the fact that it is a benign tumor, treatment is not necessary unless the tumor becomes painful and restricts movement. The tumors are usually surgically removed for cosmetic reasons. However, majority of surgeries performed today result in a visible scar.
[0060] Fat cell crystallization occurs prior to other cell types. This property will allow selective treatment of the lipoma tumors using ice pellets or crystals. The ice pellets will be fired using any of the handles mentioned above to the location of the tumor. The treatment can occur in two different methods. In the first method the pellets will be fired to the location of the tumor with low kinetic energy that will not allow skin layers' penetration. The pellets will cool the layers of the skin where the layer of the fat will selectively crystalize and be eliminated by macrophages. In the second method, the pellets will be fired in high kinetic energy to the location of the tumor and will penetrate the skin layers to reach the inner layers. The penetration of the pellets will generate channels in the skin layers. The ice pellets will remain in the end of the channel and will cool the surrounding tissue including the fat cells while the fat skin layers remain intact.
Keloid-Scar Tissue Reduction
[0061] After the skin is injured, it usually forms a flat scar to protect the wound site. A keloid is defined as a scar tissue that grew excessively to sometimes reach a size greater than that of the wound. In many cases the Keloid may become itchy and painful. Treatment can be performed using cryosurgery or cryotherapy in which the keloid scar is frozen and this results in scar shrinkage.
[0062] Ice pellets or crystals can target keloid scars locally either by skin penetration or the firing of pellets onto the keloid scar. A handle for firing pellets can be located directly at the keloid scar. The fired pellets freeze the keloid and result in the death of skin cells around it and shrinkage of the scar. The ice pellets can either penetrate the skin or freeze the outer skin layer.
[0063] In addition, the firing of the ice pellets can be made to occur internally inside the keloid scar, as illustrated in
Hyperhidrosis
[0064] Excessive sweating is a common problem among human beings and can sometimes be related to thyroid problems, diabetes or infections. Treatments for excessive sweating include surgical operation for cutting or destroying nerves associated with active sweat glands located under the armpit. The surgery requires collapsing the lung in order to insert a catheter through the chest for nerve destroying and thus many complications arise related to this surgery.
[0065] Using ice pellets, the sweat glands or the nerves related to it can be targeted and destroyed. At least one needle is inserted at the armpit and reaches the sweat glands. The needles fires pellets to the location of the glands and selectively freeze sweat glands leading to death of the sweat glands.