Patent Application
20220047315
The present disclosure relates generally to cryotherapy treatment systems and applicators.
Excess body fat, or adipose tissue, may be present at various locations of a subject's body and may detract from personal appearance. Aesthetic improvement of the human body often involves the selective removal of adipose tissue located at the abdomen, thighs, buttocks, knees, submental region, face, and arms, as well as other locations. Invasive procedures (e.g., liposuction), however, tend to be associated with relative high costs, long recovery times, and increased risk of complications. Injection of drugs for reducing adipose tissue can cause significant swelling, bruising, pain, numbness, and/or induration.
Conventional non-invasive treatments for reducing adipose tissue often include regular exercise, application of topical agents, use of weight-loss drugs, dieting, or a combination of these treatments. One drawback of these non-invasive treatments is that they may not be effective or even possible under certain circumstances. For example, when a person is physically injured or ill, regular exercise may not be an option. Topical agents and orally administered weight-loss drugs are not an option if, as another example, they cause an undesirable reaction, such as an allergic or negative reaction. Additionally, non-invasive treatments may be ineffective for selectively reducing specific regions of adiposity, such as localized adipose tissue along the hips, abdomen, thighs, or the like.
In the drawings, identical reference numbers identify similar elements or acts.
The present disclosure describes treatment systems, applicators, and methods for affecting targeted sites. Several embodiments are directed to treatment systems having one or more of the following features:
Several of the details set forth below are provided to describe the following examples and methods in a manner sufficient to enable a person skilled in the relevant art to practice, make, and use them. Several of the details and advantages described below, however, may not be necessary to practice certain examples and methods of the technology. Additionally, the technology may include other examples and methods that are within the scope of the technology but are not described in detail.
Some aspects of the technology are directed to an applicator for selectively affecting a subject's subcutaneous tissue. The applicator can include a housing and a treatment cup mounted in the housing. The treatment cup can define a tissue-receiving cavity and include a temperature-controlled surface. The applicator can also include at least one thermal device coupled to the treatment cup and configured to receive energy via a flexible connector coupled to the applicator and to cool the temperature-controlled surface. The applicator can further include at least one vacuum port coupled to the treatment cup and configured to provide a vacuum to draw the subject's tissue into the tissue-receiving cavity and against at least a portion of a treatment area of the temperature-controlled surface to selectively damage and/or reduce the subject's subcutaneous tissue. The applicator can have one or more of the following: (a) a ratio of the treatment area to weight greater than or equal to 5 square inches per lb, or (b) a ratio of the treatment area to tissue-draw depth greater than or equal to 8 inches.
In another aspect, the present technology includes an apparatus for treating a subject's tissue. The apparatus includes at least one heat-exchanger plate having a cooling surface and at least one thermal unit thermally contacting the at least one heat-exchanger plate. The apparatus also includes a thermal feathering feature extending along at least portion of a perimeter of the at least one heat-exchanger plate. The thermal feathering feature can be in thermal contact with the at least one thermal unit such that a peripheral cooling surface of the thermal feathering feature is warmer than the cooling surface so that the subject's tissue directly underlying the peripheral cooling surface is damaged or reduced but to a lesser extent than the subject's targeted tissue directly below and cooled by the cooling surface.
In a further aspect, the present technology includes a kit for treating a subject's tissue. The kit includes plurality of applicators, each applicator including a treatment cup defining a tissue-receiving cavity and having a temperature-controlled surface configured to cool and selectively reduce the subject's tissue. At least some of the applicators can have different dimensions to treat differently-sized treatment sites. The kit also includes a connector configured to operably couple a single applicator to a control unit of a treatment system. Each applicator can include an interconnect section configured to releasably couple the applicator to the connector.
In yet another aspect, the present technology includes a treatment system for cooling and selectively affecting a subject's tissue. The treatment system can include at least one applicator including a treatment cup configured to be in thermal communication with the subject's tissue, and a control unit operably coupled to the at least one applicator. The control unit can include a cooling unit configured to cool the treatment cup of the at least one applicator, and at least one vacuum unit configured to apply a vacuum unit to the subject's tissue via the treatment cup. The at least one vacuum unit can be configured to reach a target vacuum pressure with at least one of (a) an amount of overshoot that is no more than 10% of the target pressure or (b) an amount of undershoot that is no more than 10% of the target pressure.
In still another aspect, the present technology includes a gel trap for fluidically coupling a vacuum line to a tissue-receiving cavity of an applicator. The gel trap includes a container configured to capture gel, and at least one sealing member configured to sealingly engage the applicator to fluidically couple the vacuum line to a vacuum port of the applicator such that the container captures gel drawn out of the tissue-receiving cavity while allowing air flow between the tissue-receiving cavity and the vacuum line to hold a subject's tissue in the tissue-receiving cavity.
Some of the embodiments disclosed herein can be for cosmetically beneficial alterations of target regions. Some cosmetic procedures may be for the sole purpose of altering a target region to conform to a cosmetically desirable look, feel, size, shape and/or other desirable cosmetic characteristic or feature. Accordingly, at least some embodiments of the cosmetic procedures can be performed without providing an appreciable therapeutic effect (e.g., no therapeutic effect). For example, some cosmetic procedures may not include restoration of health, physical integrity, or the physical well-being of a subject. The cosmetic methods can target subcutaneous regions to change a human subject's appearance and can include, for example, procedures performed on a subject's submental region, abdomen, hips, legs, arms, face, neck, ankle region, or the like. In other embodiments, however, cosmetically desirable treatments may have therapeutic outcomes (whether intended or not), such as psychological benefits, alteration of body hormone levels (by the reduction of adipose tissue), etc.
Reference throughout this specification to “one example,” “an example,” “one embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the example is included in at least one example of the present technology. Thus, the occurrences of the phrases “in one example,” “in an example,” “one embodiment,” or “an embodiment” in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures, routines, stages, or characteristics may be combined in any suitable manner in one or more examples of the technology.
The headings provided herein are for convenience only and are not intended to limit or interpret the scope or meaning of the technology.
The applicators 102 can be used to perform medical treatments to provide therapeutic effects and/or cosmetic procedures for cosmetically beneficial effects. Without being bound by theory, selective effects of cooling are believed to result in, for example, membrane disruption, cell shrinkage, disabling, disrupting, damaging, destroying, removing, killing, and/or other methods of lipid-rich cell alteration. Such alteration is believed to stem from one or more mechanisms acting alone or in combination. It is thought that such mechanism(s) trigger an apoptotic cascade, which is believed to be the dominant form of lipid-rich cell death by non-invasive cooling. In any of these embodiments, the effect of tissue cooling can be the selective reduction of lipid-rich cells by a desired mechanism of action, such as apoptosis, lipolysis, or the like. In some procedures, the applicators 102 can cool the skin surface and/or targeted tissue to cooling temperature in a range of from about −25° C. to about 20° C. In other embodiments, the cooling temperatures can be from about −20° C. to about 10° C., from about −18° C. to about 5° C., from about −15° C. to about 5° C., or from about −15° C. to about 0° C. In further embodiments, the cooling temperatures can be equal to or less than −5° C., −10° C., −15° C., or in yet another embodiment, from about −15° C. to about −25° C. Other cooling temperatures and temperature ranges can be used.
Apoptosis, also referred to as “programmed cell death”, is a genetically-induced death mechanism by which cells self-destruct without incurring damage to surrounding tissues. An ordered series of biochemical events induce cells to morphologically change. These changes include cellular blebbing, loss of cell membrane asymmetry and attachment, cell shrinkage, chromatin condensation and chromosomal DNA fragmentation. Injury via an external stimulus, such as cold exposure, is one mechanism that can induce cellular apoptosis in cells. Nagle, W. A., Soloff, B. L., Moss, A. J. Jr., Henle, K. J. “Cultured Chinese Hamster Cells Undergo Apoptosis After Exposure to Cold but Nonfreezing Temperatures” Cryobiology 27, 439-451 (1990).
One aspect of apoptosis, in contrast to cellular necrosis (a traumatic form of cell death causing local inflammation), is that apoptotic cells express and display phagocytic markers on the surface of the cell membrane, thus marking the cells for phagocytosis by macrophages. As a result, phagocytes can engulf and remove the dying cells (e.g., the lipid-rich cells) without eliciting an immune response. Temperatures that elicit these apoptotic events in lipid-rich cells may contribute to long-lasting and/or permanent reduction and reshaping of subcutaneous adipose tissue.
One mechanism of apoptotic lipid-rich cell death by cooling is believed to involve localized crystallization of lipids within the adipocytes at temperatures that do not induce crystallization in non-lipid-rich cells. The crystallized lipids may selectively injure these cells, inducing apoptosis (and may also induce necrotic death if the crystallized lipids damage or rupture the bi-lipid membrane of the adipocyte). Another mechanism of injury involves the lipid phase transition of those lipids within the cell's bi-lipid membrane, which results in membrane disruption or dysfunction, thereby inducing apoptosis. This mechanism is well-documented for many cell types and may be active when adipocytes, or lipid-rich cells, are cooled. Mazur, P., “Cryobiology: the Freezing of Biological Systems” Science, 68: 939-949 (1970); Quinn, P. J., “A Lipid Phase Separation Model of Low Temperature Damage to Biological Membranes” Cryobiology, 22: 128-147 (1985); Rubinsky, B., “Principles of Low Temperature Preservation” Heart Failure Reviews, 8, 277-284 (2003). Other possible mechanisms of adipocyte damage, described in U.S. Pat. No. 8,192,474, relate to ischemia/reperfusion injury that may occur under certain conditions when such cells are cooled as described herein. For instance, during treatment by cooling as described herein, the targeted adipose tissue may experience a restriction in blood supply and thus be starved of oxygen due to isolation as a result of applied pressure, cooling which may affect vasoconstriction in the cooled tissue, or the like. In addition to the ischemic damage caused by oxygen starvation and the buildup of metabolic waste products in the tissue during the period of restricted blood flow, restoration of blood flow after cooling treatment may additionally produce reperfusion injury to the adipocytes due to inflammation and oxidative damage that is known to occur when oxygenated blood is restored to tissue that has undergone a period of ischemia. This type of injury may be accelerated by exposing the adipocytes to an energy source (via, e.g., thermal, electrical, chemical, mechanical, acoustic, or other means) or otherwise increasing the blood flow rate in connection with or after cooling treatment as described herein. Increasing vasoconstriction in such adipose tissue by, e.g., various mechanical means (e.g., application of pressure or massage), chemical means or certain cooling conditions, as well as the local introduction of oxygen radical-forming compounds to stimulate inflammation and/or leukocyte activity in adipose tissue may also contribute to accelerating injury to such cells. Other yet-to-be understood mechanisms of injury may exist.
In addition to the apoptotic mechanisms involved in lipid-rich cell death, local cold exposure is also believed to induce lipolysis (i.e., fat metabolism) of lipid-rich cells and has been shown to enhance existing lipolysis which serves to further increase the reduction in subcutaneous lipid-rich cells. Vallerand, A. L., Zamecnik. J., Jones, P. J. H., Jacobs, I. “Cold Stress Increases Lipolysis, FFA Ra and TG/FFA Cycling in Humans” Aviation, Space and Environmental Medicine 70, 42-50 (1999).
One expected advantage of the foregoing techniques is that the subcutaneous lipid-rich cells in the target region can be reduced generally without collateral damage to non-lipid-rich cells in the same region. In general, lipid-rich cells can be affected at low temperatures that do not affect non-lipid-rich cells. As a result, lipid-rich cells, such as those associated with highly localized adiposity (e.g., adiposity along the abdomen, submental adiposity, submandibular adiposity, facial adiposity, etc.), can be affected while non-lipid-rich cells (e.g., myocytes) in the same generally region are not damaged. The unaffected non-lipid-rich cells can be located underneath lipid-rich cells (e.g., cells deeper than a subcutaneous layer of fat), in the dermis, in the epidermis, and/or at other locations.
In some procedures, the treatment system 100 can remove heat from underlying tissue through the upper layers of tissue and create a thermal gradient with the coldest temperatures near the cooling surface, or surfaces, of the applicators 102 (i.e., the temperature of the upper layer(s) of the skin can be lower than that of the targeted underlying target cells). It may be challenging to reduce the temperature of the targeted cells low enough to be destructive to these target cells (e.g., induce apoptosis, cell death, etc.) while also maintaining the temperature of the upper and surface skin cells high enough so as to be protective (e.g., non-destructive). The temperature difference between these two thresholds can be small (e.g., approximately, 5° C. to about 20° C., less than 5° C., less than 10° C., less than 15° C., less than 20° C., etc.). Protection of the overlying cells (e.g., typically water-rich dermal and epidermal skin cells) from freeze damage during dermatological and related aesthetic procedures that involve sustained exposure to cold temperatures may include improving the freeze tolerance and/or freeze avoidance of these skin cells by using, for example, cryoprotectants for inhibiting or preventing such freeze damage.
If an inadvertent skin freeze occurs, tissue can be rapidly rewarmed as soon as practicable after a skin freeze event has occurred to limit, reduce, or prevent damage and adverse side effects associated with the skin freeze event. After skin freezing begins, tissue can be rapidly warmed as soon as possible to minimize or limit damage to tissue, such as the epidermis. In some procedures, skin tissue is partially or completely intentionally frozen for a predetermined period of time and then warmed. According to one embodiment, an applicator can warm shallow tissue using, for example, thermoelectric elements in the device. Thermoelectric elements can include Peltier devices capable of operating to establish a desired temperature (or temperature profile) along the surface. In other embodiments, the applicator outputs energy to warm tissue. For example, the applicator can have electrodes that output radiofrequency energy for warming tissue. In some procedures, the tissue can be warmed at a rate of about 1° C./s, 2° C./s, 2.5° C./s, 3° C./s, 5° C./s, or other rate selected to thaw frozen tissue after the tissue has been partially or completely frozen for about 10 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, or other suitable length of time. If the subject 101 experiences discomfort (e.g., discomfort associated with skin freezing, excessive tissue draw, etc.), the subject 101 can use a notifier device 103 to summon the operator, clinician, physician, etc. In some embodiments, when the subject 101 presses a button of the notifier device 103, a healthcare worker is notified via a mobile device, such as a pager, a smartphone, etc. The healthcare worker can evaluate the subject 101 during and after warming of tissue. The system 100 can also perform additional monitoring in response to notifications to identify and monitor adverse events. The notifier device 103 can also include buttons for two-way communication (e.g., two-way talking via a local network or a wide area network), indicating discomfort level, or the like.
Although the illustrated applicators 102 of
If a liner or gel pad (not shown) is used with the applicator 102a, the sealing element 152 can engage the liner or gel pad overlying the treatment site. For example, the liner can line the cup 156 and can be perforated such that a vacuum can be drawn through the liner to urge the subject's skin against the liner, thereby maintaining thermal contact between the tissue and the cup 156 via the liner. The cup 156 can be thermally conductive to efficiently cool the entire volume of targeted tissue retained in the applicator 102a.
The geometries of the cup 156 and sealing element 152 can be selected to conform to a contour of a cutaneous layer. For example, the shape of a typical human torso may vary between having a relatively large radius of curvature, e.g., on the stomach or back, and having a relatively small radius of curvature, e.g., on the abdominal sides. Accordingly, the tissue-receiving cavity 158 of the cup 156 can have a substantially U-shaped cross section, V-shaped cross section, or partially circular/elliptical cross-section, as well as or other cross-sectional shapes suitable for receiving tissue and matching body contours, and in particular shapes approximated by a higher-order parabolic polynomial (e.g., 4th order or higher). The thermal properties, shape, and/or configuration of the cup 156 can be selected based on, for example, target treatment temperatures and/or volume of the targeted tissue. The maximum depth of the tissue-receiving cavity 158 can be selected based on, for example, the volume of targeted tissue, characteristics of the targeted tissue, and/or desired level of patient comfort. Embodiments of the tissue-receiving cavity 158 for treating large volumes of tissue (e.g., adipose tissue along the abdomen, hips, buttock, etc.) can have a maximum depth equal to or less than about 2 cm, 5 cm, 10 cm, 15 cm, 20 cm, or 30 cm, for example. Embodiments of the tissue-receiving cavity 158 for treating small volumes (e.g., a small volume of submental tissue) can have a maximum depth equal to or less than about 0.5 cm, 2 cm, 2.5 cm, 3 cm, or 5 cm, for example. The sealing element 152 can be fitted to individual lipid-rich cell deposits to achieve an approximately air-tight seal, achieve the vacuum pressure for drawing tissue into the tissue-receiving cavity 158, maintain suction to hold the tissue, massage tissue (e.g., by altering pressure levels), and use little or no force to maintain contact between the applicator 102a and a patient.
The applicator 102a can further include one or more thermal devices 164 coupled to, embedded in, or otherwise in thermal communication with the temperature-controlled surface 160 of the cup 156. The thermal devices 164 can include, without limitation, one or more thermoelectric elements (e.g., Peltier-type elements), fluid-cooled elements, heat-exchanging units, or combinations thereof. In a cooling mode, fluid-cooled elements can cool the backside of the thermoelectric elements to keep the thermoelectric elements at or below a target temperature. In a heating mode, fluid-cooled elements can heat the backside of the thermoelectric elements to keep the thermoelectric elements at or above a target temperature. In some embodiments, the thermal devices 164 include only fluid-cooled elements or only non-fluid-cooled elements. The thermal devices 164 can be coupled to, embedded in, or associated with the cup 156. Although the illustrated embodiment has two thermal devices 164, in other embodiments the applicator 102a can have any desired number of thermal devices 164. The number, positions, configurations, and operating temperatures of the thermal devices 164 can be selected based on cooling/heating suitable for treatment, desired power consumption, or the like.
The applicator 102a can be used to cool a subcutaneous target region 166, e.g., by transferring heat from subcutaneous, lipid-rich tissue 168 via the cup 156 to the thermal devices 164. The temperature-controlled surface 160 can thermally contact an area of the subject's skin less than or equal to about 20 cm2, 40 cm2, 80 cm2, 100 cm2, 140 cm2, 160 cm2, 180 cm2, 200 cm2, 300 cm2, 500 cm2, or other suitable area. For example, the temperature-controlled surface area 160 can be, for example, equal to or less than 20 cm2, 40 cm2, 80 cm2, 100 cm2, 140 cm2, 160 cm2, 180 cm2, 200 cm2, 300 cm2, or another suitable area. The temperature-controlled surface 160 can be cooled to a temperature equal to or less than a selected temperature (e.g., 5° C., 0° C., −2° C., −5° C., −7° C., −10° C., −15° C., −20° C., −25° C., etc.) to cool most of the skin surface 155 of the retained tissue. In one embodiment, most of the temperature-controlled surface 160 can be cooled to a temperature equal to or less than about 0° C., −2° C., −5° C., −10° C., or −15° C. In some embodiments, the temperature-controlled surface 160 is cooled to a temperature of about −11° C., the skin surface 155 is cooled to a temperature of about −10° C., and the subcutaneous target region 166 is cooled to temperatures within a range from about −8° C. to about 10° C. The cooled temperature of the subcutaneous target region 166 can vary based on the tissue depth, e.g., subcutaneous tissue within 1.5 mm of the skin surface 155 can be cooled to about −8° C., subcutaneous tissue within 11.5 mm of the skin surface 155 can be cooled to about 4° C., and subcutaneous tissue deeper than 11.5 mm can be cooled to about 10° C.
The heat extracted from the target region 166 can be carried away from the thermal devices 164 via a circulating coolant (not shown), as described in greater detail below. In some embodiments, the cooling treatment primarily affects lipid-rich cells in the target region 166 with little or no reduction or damage to non-lipid-rich cells in or near the region 166 (e.g., cells in the dermis 170 and/or epidermis 172).
The applicator 102a can include a trap 165 that selectively captures substances (e.g., cryoprotectant gel, liquid, condensation, etc.) drawn into the vacuum port 162. The trap 165 can hold the captured substances away from the applicator-skin interface to maintain a high area of thermal contact and prevent the substances from reaching downstream components. The trap 165 can include a chamber 171, an outlet 173, and an air-permeable element 167 (e.g., an air-permeable and gel-impermeable membrane) covering the outlet 173. In some embodiments, the trap 165 functions as a gel trap. When the vacuum is started, air (indicated by arrows) can be drawn into and through the vacuum port 162. Gel 169 can also be drawn through the vacuum port 162 and into the trap 165. Air in the chamber 171 can flow through the air-permeable element 167 and into a passageway 177 between the trap 165 and a backside receiving feature or manifold 175. The air ultimately flows away from the applicator 102 via the connector 104A (
Referring again to
The connector 104a can also include one or more electrical lines 112 for providing power to the applicator 102a and one or more control lines 116 for providing communication between the control unit 106 (
Referring again to
A pressurization device or vacuum system 123 (illustrated in phantom line) can provide suction to the applicator 102 via the vacuum line 125 (
Air pressure can be controlled by one or more regulators located between the pressurization device 123 and the applicator 102. The control unit 106 can control the vacuum level to, for example, draw tissue into the applicator 102 while maintaining a desired level of comfort. If the vacuum level is too low, a liner assembly, gel pad, tissue, etc. may not be drawn adequately (or at all) into and/or held within the applicator 102. If the vacuum level is too high when preparing the applicator 102, a liner assembly can break (e.g., rupture, tear, etc.). If the vacuum level is too high during treatment, the patient can experience discomfort, bruising, or other complications. According to certain embodiments, approximately 0.5 inHg, 1 inHg, 2 inHg, 3 inHg, 5 inHg, 7 inHg, 8 inHg, 10 inHg, or 12 inHg vacuum is applied to draw or hold the liner assembly, tissue, etc. Other vacuum levels can be selected based on the characteristics of the tissue, desired level of comfort, and vacuum leakage rates. Vacuum leak rates of the applicator 102 can be equal to or less than about 0.2 LPM, 0.5 LPM, 1 LPM, or 2 LPM at the pressure levels disclosed herein. For example, the vacuum leak rate can be equal to or less than about 0.2 LPM at 8 inHg, 0.5 LPM at 8 inHg, 1 LPM at 8 inHg, or 2 LPM at 8 inHg. The configuration of the pressurization device 123 and applicator 102 can be selected based on the desired vacuum levels, leakage rates, and other operating parameters.
The power supply 110 can provide a direct current voltage for powering electrical elements of the applicators 102 via the line 112 (
Different vacuum levels can be utilized during treatment sessions. For example, relatively strong vacuums can be used to pull the subject's tissue into the applicator 102. A weaker vacuum can be maintained to hold the subject's tissue against the thermally conductive surface. If suitable thermal contact is not maintained (e.g., the subject's skin moves away from the thermally conductive surface), the vacuum level can be increased to reestablish suitable thermal contact. In other procedures, a generally constant vacuum level can be used throughout the treatment session.
In some embodiments, a treatment profile includes specific profiles for each applicator 102 to concurrently or sequentially treat multiple treatment sites, including, but not limited to, sites along the subject's torso, abdomen, legs, buttock, legs, face and/or neck (e.g., submental sites, submandibular sites, etc.), knees, back, arms, ankle region, or other treatment sites. The vacuum levels can be selected based on the configuration of the cup. Strong vacuum levels can be used with relatively deep cups whereas weak vacuum levels can be used with relatively shallow cups. The vacuum level and cup configuration can be selected based on the treatment site and desired volume of tissue to be treated. In some embodiments, the controller 114 can be incorporated into the applicators 102 or another component of the treatment system 100. Additional examples of control units and controllers are described below in connection with
The control unit 206 includes various components for controlling the treatment applied to the patient's tissue via the applicators 202. In some embodiments, for example, the control unit 206 includes a cooling system or unit 212 operably coupled to the treatment cups 208 of the applicators 202. The cooling system 212 can be identical or similar to the cooling system 105 of
The control unit 206 optionally includes a first vacuum system or unit 218a operably coupled to the first treatment cup 208a via a first vacuum line 220a, and a second vacuum system or unit 218b operably coupled to the second treatment cup 208b via a second vacuum line 220b. Although the first and second vacuum systems 218a, 218b (collectively, “vacuum systems 218”) are illustrated as separate components, in other embodiments the first and second vacuum systems 218a, 218b can be replaced with a single vacuum system for both applicators 202. Similar to the pressurization device 123 of
The control unit 206 can include various hardware and software components for controlling the applicators 202, cooling system 212, and vacuum systems 218. In the illustrated embodiment, for example, the control unit 206 includes a main controller 222, a first applicator controller 224a, and a second applicator controller 224b. The main controller 222 can be operably coupled to the cooling system 212, vacuum systems 218, and the first and second applicator controllers 224a, 224b (collectively, “applicator controllers 224”) to control the operation thereof. In some embodiments, the main controller 222 is electrically coupled to each of these components to provide power and control signals thereto, and can also receive status signals, sensor data (e.g., moisture data, flow rates, etc.), and/or other data from the components. For example, the main controller 222 can send control signals to the cooling system 212 to control the amount and/or rate of cooling, coolant flow rates, and/or other operational parameters. The main controller 222 can also receive sensor data from the cooling system 212 (e.g., temperature data, flow data, coolant level data) to assess the status of the cooling system 212. As another example, the main controller 222 can independently send control signals to the first and second vacuum systems 218a, 218b to control the amount of vacuum applied via the first and second applicators 202a, 202b, respectively. The main controller 222 can also receive sensor data from the first and/or second vacuum systems 218a, 218b (e.g., pressure data, flow data, etc.) to determine whether a suitable amount of pressure is being applied, or whether the pressure level should be adjusted.
In the illustrated embodiment, the main controller 222 is not directly connected to the circuit boards 210, and is instead indirectly coupled via the respective applicator controllers 224. As described in greater detail below, the circuit boards 210 located within the applicators 202 can be configured to perform a limited set of operations, such as routing data and/or signals between the applicator controllers 224 and the applicator components associated with the treatment cups 208 (e.g., thermal devices, sensors, etc.). The remaining operations (e.g., data processing, control of applicator components, etc.) can be performed by the main controller 222 and/or the applicator controllers 224. In some embodiments, the first and second applicator controllers 224a, 224b can be operated independently from each other so that the first and second applicators 202a, 202b can apply different treatment profiles to the patient (e.g., based on the particular patient location to be treated).
The treatment system 200 further includes a computing device 226. The computing device 226 can be configured to receive input from an operator of the treatment system 200 via user interface elements such as a display 228 (e.g., a monitor or touchscreen). The computing device 226 can transmit the user input to the main controller 222, which converts the user input into control signals for operating the various system components (e.g., applicators 202, cooling system 212, and/or vacuum systems 218). Conversely, data received from the system components can be transmitted by the main controller 222 to the computing device 226 and be displayed to the user via the display 228. Optionally, the computing device 226 can be operably coupled to a card reader 230. The card reader 230 can be configured to receive a card that provides security information, treatment profile information, patient information, and/or other information relevant to the operation of the treatment system 200, as described in greater detail below in connection with
The operation of the treatment system 200 can be powered by a power system or unit 232. The power system 232 can receive power from an external power source such as an electrical wall outlet (not shown), and can be electrically coupled to the main controller 222 and computing device 226 to provide power thereto. The external power source can have a line voltage within a range from 100 V to 240 V, such as 100 V, 120 V, 200 V, 220 V, or 240 V. The main controller 222 can provide power to the remaining components of the treatment system 200 (e.g., circuit boards 210, cooling system 212, vacuum systems 218, and/or applicator controllers 224). The power system 232 can be configured to allow the treatment system 200 to operate with a variety of different voltages from the external power source. For example, the power system 232 can include a transformer circuit that automatically detects the line voltage from the external power source (e.g., 100-120, 200-240 V at 50-60 Hz) and converts the line voltage to the system voltages used by the system components (e.g., 24 V for the main controller 222, 12 V for the computing device 226). In some embodiments, the transformer circuit can automatically measure the input line voltage and AC cycles, and convert the input into a constant output (e.g., 230 V at 50-60 Hz).
It will be appreciated that the treatment system 200 can be configured in many different ways. In other embodiments, for example, some of the components of the treatment system 200 can be combined with each other (e.g., the vacuum systems 218, the main controller 222, and applicator controllers 224). Alternatively, some of the components of the treatment system 200 can be provided as discrete, separate components (e.g., the main controller 222 can be separated into two or more discrete modules). Additionally, some of the components of the treatment system 200 can be omitted in other embodiments (e.g., the second applicator 202b, second connector 240b, and second vacuum system 218b). The treatment system 200 can also include components known to those of skill in the art that are omitted from
The cooling system 212 can be configured in many different ways. In some embodiments, for example, the cooling system 212 includes a fluid chamber 240 for storing a coolant. The cooling system 212 can include a first coolant pump 242a for circulating the coolant to the first applicator 202a (
The vapor compression subsystem 244 can further include a compressor 250, a condenser 252, and a fan 254. The heated refrigerant from the evaporator 246 can be circulated through the compressor 250 and the condenser 252 before returning to the evaporator 246. The compressor 250 can be a fixed speed compressor or a variable speed compressor. A fixed speed compressor may only have two compressor speed/power settings (e.g., on (100% power) and off (0% power)), while a variable speed compressor may have multiple speed/power settings (e.g., within a range from 0% power to 100% power). For example, the cooling system can have a variable speed compressor having power settings that are variable within a range from 40% power to 100% power in order to provide different cooling capacities. The power setting of the variable speed compressor can be varied based on the particular treatment procedure, applicator, and/or target efficiency. The use of a variable speed compressor may be advantageous for improving efficiency and reducing power consumption.
The cooling system 212 can include various types of sensors (e.g., flow sensors, temperature sensors, fluid level sensors) to monitor coolant circulation and/or temperature at various points in the system (e.g., at the fluid supply and/or return lines, fluid reservoir, etc.). For example, the cooling system 212 can include a fluid level sensor 256 and/or a fluid temperature sensor 258 in the fluid chamber 240. The cooling system 212 can also include first and second flow sensors 260a, 260b at the return fluid lines 216a, 216b. The cooling system 212 can also include an air temperature sensor 262 at the condenser 252.
In some embodiments, the cooling system 212 includes a cooling controller 264 (e.g., a microcontroller). The cooling controller 264 can be configured to receive data from the various sensors, and output power and/or control signals for various components such as the first and second coolant pumps 242a, 242b, the compressor 250, and the fan 254. Optionally, the cooling controller 264 can be operably coupled to a compressor controller 266 which controls the operation of the compressor 250 and receives status signals from the compressor 250.
In some embodiments, the cooling controller 264 is configured to anticipate the heating load on the system 212 and adjust the compressor speed accordingly. For example, the compressor speed can be increased if a relatively high heating load is expected (e.g., for multi-applicator procedures and/or procedure using an applicator with a relatively large treatment surface area). The control algorithm for the variable compressor speed can provide non-proportional cooling for managing peak cooling. The cooling controller 264 can also regulate operations of the fan 254 to reduce system noise.
The cooling system 212 can be configured to operate with various types of coolants, such water, a water/ethylene glycol mixture, a water/propylene glycol mixture, a water/methanol mixture, or any other suitable coolant. The cooling system 212 can be configured to maintain the coolant at a target temperature during operation of the treatment system 200. The target temperature can be less than or equal to 0° C., −5° C., −10° C., or −15° C. The cooling system 212 can take approximately 10 minutes from the start of the treatment procedure to reach steady state. During operation, the coolant can be circulated through the cooling system 212 at a flow rate within a range from 0.8 LPM to 1.2 LPM. The fluid supply and return lines 214, 216 for circulating coolant to and from the applicators 202 can have an inner diameter of approximately 0.187 inches.
In some embodiments, the cooling system 212 is configured to cool the applicator surface at a rate within a range from 0.1° C./s to 5° C./s, or 0.2° C./s to 3° C./s. For example, the cooling rate can be 0.1° C./s, 0.2° C./s, 0.3° C./s, 0.4° C./s, 0.5° C./s, 0.6° C./s, 0.7° C./s, 0.8° C./s, 0.9° C./s, 1° C./s, 1.5° C./s, 2° C./s, 2.5° C./s, 3° C./s, 3.5° C./s, 4° C./s, 4.5° C./s, or 5° C./s. The cooling rate can be measured based on temperatures of the applicator surface during the initial cooling phase (e.g., within the first 10 minutes of cooling). The transient rate of heat removal from the applicator 202 and/or patient (e.g., the rate upon initial contact) can be greater than or equal to 200 W, such as at least 210 W, 220 W, 230 W, 240 W, 250 W, 260 W, 270 W, 280 W, 290 W, 300 W, or more. The steady state rate of heat removal from the applicator 202 and/or patient can be greater than or equal to 150 W, such as at least 160 W, 170 W, 180 W, 190 W, 200 W, 210 W, 220 W, 230 W, 240 W, 250 W, or more. The efficiency of the cooling system 212 (e.g., as expressed as the ratio between the heat removal rate and power usage) can be greater than or equal to 75%, or within a range from 50% to 95%. For example, the efficiency can be at least 50%, 60%, 70%, 75%, 80%, 85%, 90%, or 95%. The improved efficiency of the cooling system 212 can reduce the amount of heating of the surrounding environment during the treatment procedure.
In some embodiments, the cooling system 212 is configured to precool the coolant to the target temperature before starting the treatment procedure, e.g., to avoid pumping excess heat into the room during the start of the procedure. Precooling can be performed on a small volume of coolant using a TEC-based system. The treatment procedure can then be initiated using the chilled coolant.
As previously described with respect to
After exiting the fluid trap 270, the air passes through a proportional valve 272 and a vacuum pump 274, and exits the vacuum system 218. Optionally, the vacuum system 218 can include a bleed valve 276 between the fluid trap 270 and proportional valve 272. In some embodiments, the vacuum system 218 is a single-stage vacuum system (e.g., includes a single proportional valve 272 between the vacuum pump 274 and the applicator 202). The vacuum pump 274 can be configured to produce an air flow rate that is sufficiently high to rapidly evacuate air from the treatment system 200 (e.g., tubing, gel traps, etc.). For example, the air flow rate (e.g., as measured at the pump 274) can be at least 10 LPM, 15 LPM, or 20 LPM.
In some embodiments, the vacuum system 218 is configured to rapidly reach and maintain a target vacuum pressure with little or no oscillation (e.g., little or no overshoot and/or undershoot of the target pressure). The target vacuum pressure can be within a range from 3 inHg to 12 inHg, such as 8 inHg. The amount of time to reach the target vacuum pressure can be less than or equal to 5 seconds, 4 seconds, 3 seconds, 2 seconds, or 1 second. The amount of overshoot can be less than or equal to 20%, 15%, 10%, or 5% of the target vacuum pressure. The amount of undershoot can be less than or equal to 20%, 15%, 10%, or 5% of the target vacuum pressure. The dampening ratio of the overshoot to undershoot (e.g., upon initial vacuum draw and/or after a disturbance to the applied vacuum) can be within a range from 0.3 to 0.7, or approximately 0.7, 0.5, or 0.3. In some embodiments, for example, the vacuum system 218 reaches the target pressure in no more than 3 seconds with no more than 20% overshoot/undershoot.
Additionally, the vacuum system 218 can be configured to maintain the target vacuum pressure during the treatment procedure with little or no pressure drop or loss. In some embodiments, the total pressure drop or loss is no more than 50%, 40%, 30%, 20%, 10%, or 5% of the target pressure value. For example, the total pressure drop and/or loss across the vacuum system 218 can be no more than 3 inHg for a flow rate of 15 LPM. As described in greater detail below, the fittings between the vacuum system 218 and the other components of the treatment system 200 (e.g., between the connector 204 of
The vacuum system 218 can include various types of sensors (e.g., pressure sensors, flow sensors) to detect whether the applied vacuum pressure is too high or too low. In some embodiments, for example, the vacuum system 218 can include at least one sensor 278 configured to monitor air flow within the vacuum system 218. The vacuum system 218 can use the flow measurements to reliably detect conditions that may lead to “pop off” (e.g., vacuum pressure too low), “pop on” (e.g., vacuum pressure too high), leaks, or an improper seal between the applicator and the patient tissue. Pop off may occur if the vacuum pressure is less than a particular value (e.g., a value of 3 inHg, or within a range from 3 inHg to 7 inHg) for a certain time period (e.g., at least 3 seconds). Pop on may occur if the vacuum pressure is greater than a particular value (e.g., a value of 7 inHg, or within a range from 7 inHg to 12 inHg) for a particular time period (e.g., at least 3 seconds). Optionally, the sensor 278 can be located along the portion of the vacuum line near the vacuum pump 274, such as between the proportional valve 272 and the fluid trap 270. The flow-based techniques described herein for detecting pop off/pop on may be more robust and accurate than other techniques (e.g., pressure-based detection), and can be used to avoid vacuum conditions that are likely to adversely affect patient treatment. In some embodiments, the sensor 278 is configured to determine air flow based on pressure measurements (e.g., by calculating flow rate based on the pressure drop between two spaced-part pressure sensors). In other embodiments, the sensor 278 can directly measure air flow (e.g., by directly detecting a mass or volume rate of air flow). Optionally, the vacuum system 218 can also include a sensor 280 configured to measure vacuum pressure between the fluid trap 270 and the flow sensor 278.
The vacuum system 218 can also include a vacuum controller 282 (e.g., a microcontroller) for monitoring and controlling operation of the various components (e.g., vacuum pump 274, proportional valve 272, and/or bleed valve 276). The sensor(s) of the vacuum system 218 (e.g., sensor 278, 280, etc.) can provide feedback to a vacuum controller 282 to monitor and maintain the vacuum pressure applied by the vacuum system 218. Optionally, if the sensor data indicates that a malfunction has or is likely to occur (e.g., pop off, pop on, leaks, etc.), the vacuum controller 282 can take appropriate steps, such as adjusting the operation of the vacuum system 218 and/or alerting the user.
The applicator 300 also includes a housing 304 that supports and protects the cup assembly 302 and the internal components of the applicator 300. The housing 304 can be a waterproof housing, e.g., according to at least one of IPX1, IPX3, IPX4, or IPX7. The housing 304 can include an upper housing portion 305a and a lower or bottom housing portion 305b, and the cup assembly 302 can be mounted in the upper housing portion 305a. The upper housing portion 305a and lower housing portion 305b can be anti-condensation housings. In some embodiments, the housing 304 has a length within a range from 13.5 inches to 14.5 inches (e.g., 13.99 inches), a width within a range from 4 inches to 5 inches (e.g., 4.25 inches), and a height within a range from 4 inches to 5 inches (e.g., 4.67 inches). The total weight of the applicator 300 can be within a range from 2 lbs to 5 lbs (e.g., 3 lbs).
The cup assembly 302 can include a cup 306 and a contoured sealing element 308. The cup 306 can be contoured to define a tissue-receiving cavity 310 (“cavity 310”) with a concave heat-exchange surface 312 (“surface 312”). During operation of the applicator 300, a vacuum is applied to the patient's tissue to draw the tissue into the cavity 310 and into thermal communication with the surface 312. The cup 306 can be made partially or entirely of a thermally conductive material (e.g., a metal such as aluminum) to allow for efficient heat transfer to and/or from the patient's tissue. The cup 306 can also be in thermal communication with one or more thermal devices located within the housing 304, as described below.
To provide a suitable vacuum against the tissue, the sealing element 308 can extend along the perimeter or mouth of the cavity 310 and can sealingly engage, for example, a liner assembly, the patient's skin (e.g., if the applicator 300 is placed directly against skin), a cryoprotectant gel pad, or other surface. The sealing element 308 can be configured for forming airtight seals with the skin and can be made, in whole or in part, of silicon, rubber, soft plastic, or other suitable highly compliant materials. The mechanical properties, thermal properties, shape, and/or dimensions of the sealing element 308 can be selected based on, for example, whether it contacts the skin, a liner assembly, a cryoprotectant gel pad, or the like.
The shape of the cup 306 can be designed to conform to the patient's tissue to increase the volume of tissue that can be treated and improve treatment efficacy. For example, as can be seen in
The dimensions of the cup 306 can be varied as desired. In some embodiments, for example, the width W1 of the cup 306 (
In some embodiments, the applicator 300 has a treatment area to weight ratio greater than or equal to 5 square inches/lb, 6 square inches/lb, 7 square inches/lb, 8 square inches/lb, 9 square inches/lb, 10 square inches/lb, 11 square inches/lb, 12 square inches/lb, 13 square inches/lb, 14 square inches/lb, 15 square inches/lb, 16 square inches/lb, 17 square inches/lb, 18 square inches/lb, 19 square inches/lb, or 20 square inches/lb. The applicator 300 can have a treatment area to tissue-draw depth ratio greater than or equal to 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 13 inches, 14 inches, 15 inches, 16 inches, 17 inches, 18 inches, 19 inches, or 20 inches. The tissue-draw depth of the cup 306 can be at least 50%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the depth D1.
The cup 306 can be configured to apply the vacuum to the patient's tissue via a vacuum port 318 (best seen in
The air-egress features 320 can be grooves or channels that are machined into the surface 312 of the cup 306. For example, in the illustrate embodiment, the air-egress features 320 have a branching shape that extends from the vacuum port 318 along the bottom 314 and towards the sidewalls 316a, 316b. The number, positions, and geometries of the air-egress features 320 can be selected to define an airflow pattern suitable for evacuating air between the tissue and the cup 306. The air-egress features 320 also reduce the likelihood of air bubbles between the tissue and the cup 306. The air-egress features 320 can be positioned at locations at which air tends to become trapped. If ambient air is inadvertently sucked between the cup 306 and the subject's skin, it can serve as a thermal insulator and reduce heat transfer between the applicator 300 and the subject's tissue. Such air can be removed via the air-egress features 320 to maintain suitable thermal contact throughout the entire treatment session, including relatively long sessions (e.g., sessions equal to or longer than 20 minutes, 30 minutes, 45 minutes, 1 hour, or 2 hours). In some embodiments, the vacuum port 318 is positioned at central region of the cup 306 to draw the tissue into the deepest region of the tissue-receiving cavity 310, and the air-egress features 320 extend toward a peripheral portion of the surface 312. During cooling/heating, the tissue can fill substantially the entire cavity 310. In various embodiments, the air-egress features 320 can maintain airflow paths extending to the peripheral portion of the cup 306 such that the tissue occupies at least 80%, 90%, 92.5%, 95%, 99%, or 100% of the volume of the cavity 310. Accordingly, the subject's tissue can substantially fill an entire volume of the cavity 310. In one application, the subject's tissue fills 90% or more of the volume of the cavity 310.
In some embodiments, the surfaces of the applicator 300 (e.g., the exposed surfaces of the housing 304 and cup 306) have a smooth surface finish. For example, the roughness of the surfaces can be less than or equal to Ra 65, 60, 55, 50, 45, 40, 35, 32, or 30. In some embodiments, the surface 312 of the cup 306 has an Ra less than or equal to 32, and a backside of the cup 306 has an Ra less than or equal to 63. For example, most or substantially all of the surface 312 can have an average Ra less than or equal to 25, 30, or 35. Smooth surfaces can be produced, for example, by machining followed by an anodizing process. In some embodiments, the surface 312 can be a metal surface (e.g., an aluminum surface, a metal alloy surface, etc.) that is machined, polished, and/or anodized. A smoother surface can facilitate cleaning of the applicator 300, e.g., particularly the air-egress features 320.
Referring again to
Referring next to
In the illustrated embodiment, each thermal device 330 has three thermoelectric elements 332 such that the applicator 300 includes a total of six thermoelectric elements 332 corresponding to six cooling/heating zones. In other embodiments, each thermal device 330 can have a different number of the thermoelectric elements 332 (e.g., one, two, four, five, or more) and cooling/heating zones. Additionally, the sizes of the thermoelectric elements 332 can be varied as desired to provide different cooling/heating capabilities. For example, each thermoelectric element 332 can be approximately 30 mm by 40 mm in size. The thermoelectric elements 332 can be addressable thermoelectric elements that are each independently controllable (e.g., by a remote applicator controller, as discussed in greater detail below).
Each thermal device 330 can also include a fluid-cooled element 334 attached to the backside of the thermoelectric elements 332 for cooling/heating the thermoelectric elements 332. In a cooling mode, the fluid-cooled element 334 can cool the backside of the thermoelectric elements 332 to keep the thermoelectric elements 332 at or below a target temperature. In a heating mode, the fluid-cooled element 334 can heat the backside of the thermoelectric elements 332 to keep the thermoelectric elements 332 at or above a target temperature. The fluid-cooled element 334 can include internal fluid channels or passages (not shown) and ports 335 for circulation of a coolant from a cooling system (e.g., cooling system 212 of
A first circuit board 338a and a second circuit board 338b (collectively, “circuit boards 338”) can be electrically coupled to the thermoelectric elements 332, the sensors 326, the sensors 333, and/or other electronic components of the applicator 300. Optionally, the circuit boards 338 can be electrically coupled to each other via a cable 340 or other electrical connector. The circuit boards 338 may be identical or generally similar to the circuit boards 210 of
Optionally, each circuit board 338 can include a contamination circuit configured to detect the presence and/or ingress of fluid. For example, fluids such as water (e.g., from drip condensation) or coolant (e.g., due to leaks) may be present in the applicator 300 during operation. Fluid ingress may be caused by submerging the applicator 300 in liquid for extended periods of time. Fluid accumulation near thermistors can adversely affect temperature measurements. Fluid can also cause electrical shorts and/or damage the internal components of the applicator 300. Accordingly, the contamination circuit can be used to detect whether fluid has entered the applicator 300, and, if so, shut down operation of the applicator 300. For example, the contamination circuit can initially be in an open state, and can switch to a closed state if water enters the applicator 300. For example, the contamination circuit can include one or more water detectors.
The limited functionality of the circuit boards 338 can provide various benefits, such as reducing the thermal footprint of the applicator 300—excess heat can increase the load on the thermoelectric elements 332, create condensation that may adversely affect electronic components within the applicator 300, create safety issues (e.g., overheating), and reduce treatment efficacy. This approach can also reduce the electrical load for operating the applicator 300, and thus the amount and size of the wiring, which can allow for a more flexible connector cable with detachable bayonet connections, as described in detail below. For example, the wiring used in the applicator 300 can be less than or equal to 20 AWG, or less than or equal to 28 AWG. Additionally, the size, weight, and cost of the applicator 300 can be reduced. A lighter applicator 300 can be more comfortable for the patient, easier to secure to the patient's body (e.g., via straps or adhesive coupling gel), and less likely to pop off during operation.
The supply fluid line 342a and return fluid line 342b can be coupled to an interconnect assembly 344 at the distal end 301b of the applicator 300. The interconnect assembly 344 can also include interfaces 346 for receiving a vacuum line (not shown) connected to the gel trap manifold 322 (e.g., via hose barb 348), and one or more electrical lines (not shown) connected to the circuit boards 338. As described in greater detail below, the assembly receptacle 344 can include features for releasably coupling the applicator 300 to a connector (e.g., connectors 104 of
As shown in
The cup assembly 402 can include a cup 406 having a rounded, continually curved shape. In some embodiments, the width W2 of the cup 406 (
In some embodiments, the applicator 400 has a treatment area to weight ratio greater than or equal to 5 square inches/lb, 6 square inches/lb, 7 square inches/lb, 8 square inches/lb, 9 square inches/lb, 10 square inches/lb, 11 square inches/lb, 12 square inches/lb, 13 square inches/lb, 14 square inches/lb, 15 square inches/lb, 16 square inches/lb, 17 square inches/lb, 18 square inches/lb, 19 square inches/lb, or 20 square inches/lb. The applicator 400 can have a treatment area to tissue-draw depth ratio greater than or equal to 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 13 inches, 14 inches, 15 inches, 16 inches, 17 inches, 18 inches, 19 inches, or 20 inches. The tissue-draw depth of the cup 406 can be at least 50%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the depth D2.
The cup assembly 502 can include a cup 506 having a rounded, continually curved shape. In some embodiments, the width W3 of the cup 506 (
In some embodiments, the applicator 500 has a treatment area to weight ratio greater than or equal to 5 square inches/lb, 6 square inches/lb, 7 square inches/lb, 8 square inches/lb, 9 square inches/lb, 10 square inches/lb, 11 square inches/lb, 12 square inches/lb, 13 square inches/lb, 14 square inches/lb, 15 square inches/lb, 16 square inches/lb, 17 square inches/lb, 18 square inches/lb, 19 square inches/lb, or 20 square inches/lb. The applicator 500 can have a treatment area to tissue-draw depth ratio greater than or equal to 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 13 inches, 14 inches, 15 inches, 16 inches, 17 inches, 18 inches, 19 inches, or 20 inches. The tissue-draw depth of the cup 506 can be at least 50%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the depth D3.
The cup assembly 602 can include a cup 606 having a rounded, continually curved shape. As best seen in
In some embodiments, the applicator 600 has a treatment area to weight ratio greater than or equal to 5 square inches/lb, 6 square inches/lb, 7 square inches/lb, 8 square inches/lb, 9 square inches/lb, 10 square inches/lb, 11 square inches/lb, 12 square inches/lb, 13 square inches/lb, 14 square inches/lb, 15 square inches/lb, 16 square inches/lb, 17 square inches/lb, 18 square inches/lb, 19 square inches/lb, or 20 square inches/lb. The applicator 600 can have a treatment area to tissue-draw depth ratio greater than or equal to 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 13 inches, 14 inches, 15 inches, 16 inches, 17 inches, 18 inches, 19 inches, or 20 inches. The tissue-draw depth of the cup 606 can be at least 50%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the depth D4.
The cup assembly 702 can include a cup 706 having a rounded, continually curved shape. The cup 706 can have a more shallow, flattened shape compared to the applicators 300, 400, 500 of
In some embodiments, the applicator 700 has a treatment area to weight ratio greater than or equal to 5 square inches/lb, 6 square inches/lb, 7 square inches/lb, 8 square inches/lb, 9 square inches/lb, 10 square inches/lb, 11 square inches/lb, 12 square inches/lb, 13 square inches/lb, 14 square inches/lb, 15 square inches/lb, 16 square inches/lb, 17 square inches/lb, 18 square inches/lb, 19 square inches/lb, or 20 square inches/lb. The applicator 700 can have a treatment area to tissue-draw depth ratio greater than or equal to 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 13 inches, 14 inches, 15 inches, 16 inches, 17 inches, 18 inches, 19 inches, or 20 inches. The tissue-draw depth of the cup 706 can be at least 50%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the depth D5.
The applicator 800 also includes a housing 804 supporting and protecting the cup assembly 802. In some embodiments, the housing 804 has a length within a range from 3.5 inches to 4.5 inches (e.g., 4.09 inches), a width within a range from 2 inches to 3 inches (e.g., 2.31 inches), and a height within a range from 4 inches to 5 inches (e.g., 4.36 inches). The total weight of the applicator 800 can be within a range from 0.5 lbs to 1.5 lbs (e.g., 0.9 lbs).
The cup assembly 802 can include a cup 806 having a rounded, continually curved shape. The cup 806 can be designed to treat a relatively small tissue area (e.g., a submental area). In some embodiments, for example, the width W6 of the cup 806 (
In some embodiments, the applicator 800 has a treatment area to weight ratio greater than or equal to 1 squares inches/lb, 2 square inches/lb, 3 square inches/lb, 4 square inches/lb, 5 square inches/lb, 6 square inches/lb, 7 square inches/lb, 8 square inches/lb, 9 square inches/lb, 10 square inches/lb, 11 square inches/lb, 12 square inches/lb, 13 square inches/lb, 14 square inches/lb, 15 square inches/lb, 16 square inches/lb, 17 square inches/lb, 18 square inches/lb, 19 square inches/lb, or 20 square inches/lb. The applicator 800 can have a treatment area to tissue-draw depth ratio greater than or equal to 1 inch, 2 inches, 3 inches, 4 inches, 5 inches, 6 inches, 7 inches, 8 inches, 9 inches, 10 inches, 11 inches, 12 inches, 13 inches, 14 inches, 15 inches, 16 inches, 17 inches, 18 inches, 19 inches, or 20 inches. The tissue-draw depth of the cup 806 can be at least 50%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the depth D6.
The applicator 800 can include a cavity 850 for receiving a gel trap 852. The cavity 850 can be formed in the bottom 814 of the cup 806 so that a portion of the gel trap 852 is exposed. The gel trap 852 can be configured to collect gel or other fluid that may be drawn into the vacuum port 818, as described in greater detail below.
When a vacuum is drawn, the subject's skin can be held against substantially all of the cooling surface 907 at the bottom cavity 921. The region of the cooling surface 907 surrounding and adjacent the vacuum port 929 can be generally flat or slightly curved to help maintain thermal contact with the subject's skin. An operator can also view the gel trap 910 to confirm proper installation and can visually inspect the gel trap 910 at any time during treatment. A reservoir or chamber of the gel trap 910 is remote from the cooling surface 907. Captured gel 169 is held away from heat flow paths between the cooling surface 907 and the subject's tissue such that the amount of captured gel 169 does not affect cooling/heating of the target tissue to avoid interfering with treatment.
The gel trap 910 can be configured for toolless installation and/or toolless removal from the applicator 900. In installation, the gel trap 910 can establish a fluid tight connection with the manifold upon manual insertion. After treatment, the gel trap 910 can be removed, emptied, and reinstalled without using any tools. If the gel trap 910 is completely filled during a treatment session, the vacuum can be stopped and the gel trap 910 emptied. The applicator 900 can be held stationary against the subject while emptying the gel trap 910 to maintain proper applicator position. After installing a new gel trap or reinstalling the emptied gel trap 910, the vacuum can be restarted to resume treatment. In some embodiments, the applicator 900 can include a bypass line between the vacuum port 929 and the vacuum line 966. The bypass line can include one or more valves, hoses, fittings, or the like. When the gel trap 910 is removed from the applicator 900, the bypass line can be opened to maintain the vacuum. Gel traps can be replaced any number of times during a treatment without affecting tissue retention.
The holding capacity of the chamber 928 can be greater than the volume of gel/liquid expected to be drawn into the applicator 900, volume of gel used in a procedure, etc. For example, a ratio of the volume of the chamber 928 to the volume of applied gel (e.g., gel present at the skin-applicator interface at the start of the procedure) can be 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, or 5 and the chamber 928 can have a holding capacity equal to or greater than about 10 cm3, 15 cm3, 20 cm3, 25 cm3, 30 cm3, 35 cm3, 40 cm3, 45 cm3, 50 cm3, 55 cm3, 60 cm3, 65 cm3, 70 cm3, 75 cm3, 80 cm3, 85 cm3, 90 cm3, 95 cm3, 100 cm3, 200 cm3, 300 cm3, or another suitable volume. For example, a gel trap with a holding capacity of 60 cm3 can be used to perform three treatment sessions each using less than about 20 cm3 of gel. The configuration and holding capacity of the gel trap 910 can be selected based on the procedure to be performed. Optionally, the gel trap 910 can be sized such that it will not completely fill during any single treatment session.
Referring to
Referring now to
An optional strap system can be used to minimize, reduce, or substantially eliminate movement of the applicator relative to the subject. The strap system can couple to a backside 1009 (
The heat-exchanging element 1018a can include a plate, a covering, film, temperature sensors, and/or thermistors. The plate can be flat or shaped (e.g., curved) and can be made of metal or other conductive material (e.g., a rigid conductive material, a flexible conductive material, etc.). The covering can be a film, a sheet, a sleeve, or other component suitable for defining an interface surface. In one embodiment, the covering can be positioned between the plate and the subject's skin. In other embodiments, an exposed surface of the planar plate can define the exposed surface of the applicator 1000. In some embodiments, the heat-exchanging elements 1018 can have radii of curvature in one or more directions (e.g., a radius of curvature in one direction, a first radius of curvature in a first direction and a second radius of curvature in a second direction, etc.). In one embodiment, a rigid or flexible heat-exchanging element 1018 can have a radius of curvature in a direction generally parallel to the length or width of its exposed surface. Additionally, each heat-exchanging element 1018 can have the same configuration (e.g., curvature). In other embodiments, the heat-exchanging elements 1018 can have different configurations (e.g., shapes, curvatures, etc.). Applicators disclosed herein can have one of more flat heat-exchanging elements and one or more non-planar or shaped heat-exchanging elements. For example, the heat-exchanging elements 1018a, 1018c can be flat, and the heat-exchanging element 1018b can be non-planar (e.g., curved, partially spherical, partially elliptical, etc.). The shapes, dimensions, and properties (e.g., rigidity, thermal conductivity, etc.) of the heat-exchanging elements and other components of the applicator 1000 can be selected to achieve the desired interaction and heat transfer with the subject.
The thermal unit 1028a can include a thermoelectric device 1030a and a fluid-cooled device 1032a. The thermoelectric device 1030a can be coupled to and in thermal contact with the heat-exchanging element 1018a. The thermoelectric device 1030a can be a single thermoelectric cooling device or include multiple addressable thermoelectric cooling devices (e.g., two, three, or four thermoelectric cooling devices, such as Peltier devices). The thermoelectric device 1030a can include a greater or lesser number of thermoelectric elements with a variety of shapes (e.g., square, rectangular, etc.). The fluid-cooled device 1032a can exchange heat with the backside of the thermoelectric device 1030a to keep the thermoelectric device 1030a at or below a targeted temperature. The anti-condensation housings 1029a-c (e.g., foam insulation) can cover cooled components to inhibit or prevent condensation on the cooled surface from reaching electronic connections. For example, the anti-condensation housings 1029a-c can encapsulate the respective thermal units 1028 to prevent or inhibit water from reaching surrounding electrical components.
The element 1018a can be made of thermally conductive materials that at room temperature have a thermal conductivity equal to or greater than about 50 W/(mK), 100 W/(mK), 200 W/(mK), 300 W/(mK), 350 W/(mK), and ranges encompassing such thermal conductivities. The border 1035 and/or lip 1033 can have a thermal conductivity equal or less than 50%, 40%, 30%, 20%, or 10% of the thermal conductivity of the heat-exchanging element 1018a. In some embodiments, the border 1035 and/or lip 1033 can have a thermal conductivity at room temperature equal to or less than about 0.2 W/(mk), 0.5 W/(mK), 1 W/(mK), 2 W/(mk), or other suitable thermal conductivities. During a cooling cycle, a temperature along a peripheral cooling surface 1045 of the border 1035 is higher than the temperature at the cooling surface 1055 of the element 1018a. For example, the cooling surface 1045 defining the cooling zone 1005 (
The thermal characteristics of the applicator 1000 can be selected to achieve rates of cooling and rewarming of targeted tissue. For example, feathering feature 1002 can be configured to provide a defined number of Joules per unit of area or volume per unit of time can be extracted. In some embodiment, the number of Joules per unit area (e.g., Joules/inches squared) is equal or less than 40%, 30%, 20%, 10%, or 5% of the number of Joules per unit area of cooling provided by the heat-exchanging element 1018a.
Referring now to
The tiled thermal devices 1100, 1150 of
Retainer apparatuses, strap assemblies, and other components or features can be used with, or modified for use with, the applicators disclosed herein. The applicators disclosed herein can include additional features for providing a vacuum, energy (e.g., electrical energy, radiofrequency, ultrasound energy, thermal energy, etc.), and so forth. The treatment systems can include a pressurization device (e.g., a pump, a vacuum, etc.) that assists in providing contact between the applicator (such as via the interface layer or sleeve) and the patient's skin. In one embodiment, cooling units can include one or more vibrators (e.g., rotating unbalanced masses). In other embodiments, mechanical vibratory energy can be imparted to the patient's tissue by repeatedly applying and releasing a vacuum to the subject's tissue, for instance, to create a massage action during treatment. Further details regarding vacuum type devices and operation may be found in U.S. Patent Publication No. 2008/0287839. Exemplary components and features that can be incorporated into the applicators disclosed herein are described in, e.g., commonly assigned U.S. Pat. No. 7,854,754 and U.S. Patent Publication Nos. 2008/0077201, 2008/0077211, 2008/0287839, 2011/0238050 and 2011/0238051. The applicators disclosed herein may be cooled using only coolant, only thermoelectric elements, or other suitable features. In further embodiments, the treatment systems disclosed herein may also include a patient protection device incorporated into the applicators to prevent directed contact between the applicator and a patient's skin and thereby reduce the likelihood of cross-contamination between patients and/or minimize cleaning requirements for the applicator. The patient protection device may also include or incorporate various storage, computing, and communications devices, such as a radio frequency identification (RFID) component, allowing for example, use to be monitored and/or metered. Exemplary patient protection devices are described in commonly assigned U.S. Patent Publication No. 2008/0077201.
Referring now to
Referring to
In some embodiments, dimensions of the frame 1202 can correspond and be substantially equal to (e.g., ±5%) the dimensions of a cup. For example, the template 1200 can be configured to match the applicator of
Referring first to
Referring next to
As best seen in
The proximal end portion 1942 of the interconnect assembly 1940 can include an applicator interface 1946 (
The supply fluid line fittings 1930a, 1950a, return fluid line fittings 1930b, 1950b, and vacuum line fittings 1932, 1952 (collectively, “distal interface fittings”) can be any connector suitable for fluidly coupling fluid lines, such as hose barb fittings. In some embodiments, some or all of the interface fittings are dripless fittings. The use of dripless fittings can allow the applicator to be water-tight, and can also minimize loss of coolant due to fitting losses, thus avoiding the need to periodically refill the treatment system with coolant (which may introduce issues with over- or under-filling). In some embodiments, the supply fluid line fittings 1930a, 1950a and the return fluid line fittings 1930b, 1950b, when coupled, have a maximum pressure drop of 7.0 psi per couple at a coolant flow rate of 1 LPM. When coupled, the supply fluid line fittings 1930a, 1950a and the return fluid line fittings 1930b, 1950b, can be configured to withstand fluid pressures of at least 90 psi, 110 psi, or 115 psi. The vacuum line fittings 1932, 1953, when coupled, can have a maximum pressure drop of 3.0 inHg at an air flow rate of 15 LPM, and can be configured to withstand vacuum pressures of at least −20 inHg.
The electrical connectors 1934, 1954 can be any connector suitable for electrically coupling electrical lines. For example, the electrical connector 1934 can be a socket with apertures and the electrical connector 1954 can be a plug with pins that fit into the apertures, or vice-versa. The electrical connectors 1934, 1954 can each have a plurality of pins for transmitting power, control signals, data, or other types of electrical signals. In the illustrated embodiment, the electrical connectors 1934, 1954 each have a fanned-out shape, which may be advantageous for reducing the sizes of the distal connector interface 1926 and the applicator interface 1946.
The proximal end portion 1942 of the interconnect assembly 1940 can further include one or more locking features 1957 (
Referring again to
The body portion 1984 can have an elongated shape (e.g., a cylindrical shape) that terminates in a console interface 1986. The console interface 1986 can be configured to mate with the proximal connector interface 1966 of the proximal interconnect receptacle 1960. As shown in
The supply fluid line fittings 1970a, 1990a, return fluid line fittings 1970b, 1990b, and vacuum line fittings 1972, 1992 (collectively, “proximal interface fittings”) can be identical or generally similar to the corresponding distal interface fittings discussed above. For example, some or all of the proximal interface fittings can be dripless fittings. Likewise, the electrical connectors 1974, 1994 can be identical or generally similar to the electrical connectors 1934, 1954 described above, except that the electrical connectors 1974, 1994 may have a generally circular shape rather than a fanned-out shape.
Referring again to
To clean the applicator 2020, the cap 2000 can be coupled to the interconnect assembly 2018. If a gel trap is present, it can be removed from the applicator 2020. Liquid (e.g., water) can be sprayed against the cup 2021 to clean a cooling surface, air-egress features, etc. To remove substances from the vacuum flow path in the applicator 2020, the liquid can flow through a vacuum port 2022, manifold 2024, and vacuum line 2026. The liquid can be circulated along the flow path to remove gel and other contaminates that may have entered the internal air flow passageways while the cap 2000 prevents the water from contacting electrical components of the interconnect assembly 2018. The cap 2000 can be configured be used with any vacuum applicator disclosed herein.
The applicators disclosed herein may be waterproof according to at least the IPX1, IPX3, IPX4, IPX7, or other ingress Protection (IP) rating or standard for substance (e.g., water ingress) defined, for example, by ANSI/IEC 60529, IP test, or similar standard. For example, applicators (including housings, connectors, etc.) can be IPX1, IPX3, IPX4, or IPX7 compliant to allow users to wash the applicator using, for example, running water. The cap 2000 can protect the electrical components if the applicator 2020 is submerged in water. In some embodiments, the applicators can be waterproof when submerged in water at a depth of 2-9 feet for at least 1 minute, 2 minutes, 5 minutes, or 10 minutes. The connectors of the applicator 2020 can have an ingress protection IP54 rating (e.g., splash proof for electrical components).
The connection between the applicator 800 and connector 2100 can be waterproof according to at least IPX1, IPX3, IPX4, IPX7, or other ingress Protection (IP) rating or standard for substance (e.g., water ingress) defined, for example, by ANSI/IEC 60529, IP test, or similar standard. For example, the connection can be IPX1, IPX3, IPX4, or IPX7 compliant to allow users to wash the applicator 800 using, for example, running water. An internal distal end 2160 of a connector or hose 2106 can be adhered to applicator 800 to provide a watertight connection. One or more sealing members 2164 (e.g., O-rings, gaskets, etc.) can provide sealing between components at the connection. In some embodiments, a protective sleeve 2170 covers interfaces, joints, sealing members, etc. to further inhibit fluid ingress/egress. A proximal end 2180 of the hose 2106 can be adhered to a connector 2181 to provide a watertight connection. One or more sealing members 2184 (e.g., O-rings, gaskets, etc.) can provide sealing between components at the connection. In some embodiments, a protective sleeve 2190 covers interfaces, joints, sealing members, etc. to further inhibit fluid ingress/egress at interfaces. In some embodiments, the connections can be waterproof when submerged in water at a depth of 2-9 feet for at least 1 minute, 2 minutes, 5 minutes, or 10 minutes. This allows the applicator 800 and distal section of the connector 2106 to be submerged for cleaning.
The control unit 2200 can include various functional components located within the housing 2202. For example, the control unit 2200 can include any of the systems and devices described herein, such as any of the components discussed above with respect to
For example, the control unit 2200 can house one or more applicator controllers (e.g., applicator controllers 224 of
In some embodiments, the applicator controllers within the control unit 2200 are configured to power and control the operation of the thermoelectric elements within the applicators 2206. For example, the applicator controllers can be or include one or more TEC drivers configured for use with TECs. The TECs can be direct drive TECs, which may be more efficient than other types of TECs. The TEC drivers can measure the voltage and/or current to the TECs to determine the amount of power being delivered to the TECs, which may correlate to the amount of heat removed from the patient's tissue by the TECs. The voltage and/or current values can be used as feedback for controlling the amount of power delivered to the TECs, e.g., to improve treatment efficacy and safety.
Optionally, the TEC drivers can control the driving of each TEC individually, e.g., to independently control the amount of heat removed from the treatment zone corresponding to the TEC. For example, the TEC for each zone can be driven based on factors such as such as the measured temperature (e.g., of the patient's tissue at the particular zone and/or of the corresponding TEC), the power delivered to the corresponding TEC, the power delivered to other TECs, etc. In some embodiments, the driving algorithm for each zone uses a PID algorithm or loop. Different PID algorithms can be used for different applicators 2206. The inputs to the PID algorithm can include the power delivered to the TEC, the response to the measured temperature, and/or tuning parameters. The PID algorithm can assume that the amount of power commanded by the TEC driver is the same or similar to the actual amount of power delivered to the TEC. If the TEC driver detects that the commanded power is significantly different than the actual power delivered, this can indicate a problem in the system.
In some embodiments, the TEC drivers are configured to implement an anti-freeze process for reducing or avoiding freezing damage to the patient's skin surface. The tissue response to freezing can generate heat and cause the temperature of the skin surface to increase (e.g., from a target treatment temperature of −11° C. to a temperature within a range from −8° C. to −9° C. within 2-3 seconds). Accordingly, tissue freezing can be detected using temperature sensors (e.g., thermistors) within the applicator 2206 that are located adjacent or near the patient's skin (e.g., sensors 326 of
In some embodiments, the applicator controllers of the control unit 2200 are also configured to receive and process data from other electronic components of the applicators 2206, such as temperature data from one or more temperature sensors (e.g., thermistors). As previously described, each applicator 2206 can include thermistors (e.g., sensors 326, 333 of
The control unit 2200 can also include an input/output device 2214, such as a touchscreen display or monitor. The input/output device 2214 can be used by a physician or other operator to input data (e.g., commands, patient data, treatment data, etc.). For example, commands input by the physician can be converted into control signals for controlling operation of various functional components of the control unit 2200 (e.g., cooling system, vacuum system, applicator controllers, etc.). The input/output device 2214 can also be used to output information to the physician (e.g., treatment progress, sensor data, instructions, feedback, etc.). In some embodiments, sensor data and/or other data from the various functional components of the control unit 2200 can be converted into graphical, textual, audio, or other output that is shown to the physician via the input/output device 2214 so the physician can monitor treatment progress.
In some embodiments, the control unit 2200 can include other types of components for receiving input data, such as a reader or scanner 2221 (
Optionally, the control unit 2200 can be operably coupled to a notifier device (e.g., notifier device 103 of
Optionally, the control unit 2200 can include a reader 2216 (
The information (e.g., provider information, consumable ID, patient information, etc.) from the reader 2216 and/or scanner 2221 can be sent to a controller (e.g., controller 114 of
The microelectronics 2219 can be used to, for example, meter treatment cycles (e.g., treatment sessions where each purchased cycle is a single treatment session). A user can purchase treatment credits for cycles, and the new credits can be added to card 2218. In some embodiments, the user can add new credits to the card as long as at least one unused credit remains on the card. The system will be able to perform a cycle when a non-zero number of credits remain and is prohibited when a zero number of credits remain prior to the intended use. The system deducts a credit each time that an applicator treatment is started (e.g., each applicator can be independently controlled to perform a separate cycle). For example, if two applicators start treatments (whether concurrently or sequentially), two credits would be deducted from the card 2218. A multi-use card 2218 can have cycles for multiple applicators, so a single available cycle allows simultaneous operation of multiple applicators. In some embodiments, the card 2218 can include different types of credits for different types of treatment cycles. For example, the card 2218 can include a credit that allows the system to perform two independent treatments using two applicators (e.g., simultaneously or sequentially). As another example, the card 2218 can include a credit that allows the system to perform a single treatment using a single applicator. In yet another example, the card 2218 can include a credit that allows any applicator compatible with the system to be used for treatment.
The amount of treatments for which the applicators and/or control unit 2200 can be used may be limited to an amount that is predetermined, e.g., pre-purchased by the system operator, patient, etc. Accordingly, when the number of cycles on the card 2218 has been reached, the system may communicate to the operator that it is necessary to obtain, e.g., purchase, additional cycles. Optionally, when no credits remain, the card 2218 can be automatically locked to prevent future treatments using the card 2218. The card 2218 can also terminate functions based on detection of unauthorized activity, such as tempering, unauthorized attempts to add credits/cycles, etc. The card 2218 may be replenished, for example, via the internet. In non-replenishable embodiments, the card 2218 can be discarded, and another disposable card can be purchased. The disposable card 2218 may include anti-tampering software or circuitry that prevents the addition of cycles/credits.
The microelectronics 2219 may also store, for example, patient profiles, profiles of treatment parameters, anti-tampering software, and/or limits. Examples of patient profiles may include patient vitals, health records, treatment history, etc. The microelectronics 2219 can store one or more profiles indicating applicators that can be used on the patient. Examples of treatment parameters may include targeted body part or tissue, duration of a treatment, target temperatures, temperature profiles, number of cycles or sessions in a treatment, heat extraction rate during a treatment, etc. A dual card can have cycles that enable multi-applicator treatments (e.g., treatments performed by two applicators at the same time). Examples of limits include, for example, limiting certain applicators, number of applicators, treatment limits (e.g., length of treatment, temperatures, etc.), limiting systems and/or operators in specific geographic regions to specific treatments, etc. Example territory limits can restrict which territories (e.g., based on geolocation data, stored territory data, etc.), counties, and/or systems the card can be used with, thereby limiting systems and/or operators in specific geographic regions to specific treatments. A set of territory codes written into the control unit, and the card can have one code to restrict which systems a card can be used with. The card security firmware and control unit security firmware can use information from the card 2218 to determine requirements to enable treatment on applicators. The card 2218 can download security firmware or other firmware. In some embodiments, the card 2218 includes platform compatibility data for restricting use of the card with specific systems whereas universal cards 2218 can be used across systems platforms, multi-applicator treatments (e.g., current use of applicators), and/or multiple territories. In some embodiments, the card 2218 includes one or more compatibility checks for checking applicator type, software (e.g., minimum software versions in the control unit), or the like.
The microelectronics 2219 may also store card type. The card type can be, for example, standard, solo, or multi-use or dual. A standard or solo card can store a single cycle for each applicator use. A cycle can be deducted each time a treatment is started. For treatment systems with multiple applicators, each applicator can be independently controlled and causes a deduction of a cycle for each use. A dual card deducts an available cycle for each treatment cycle and allows concurrent use of two applicators. The control unit can use the stored card type to determine GUIs, temperature controls, etc. The card security firmware and the control unit security firmware can use information from the card to determine requirements to enable treatment on one or both applicators.
The system can perform one or more authentication procedures, including one or more of the features and techniques disclosed in U.S. Pat. No. 8,523,927, the disclosure of which is incorporated herein by reference in its entirety. For example, the system may invoke the authenticate routine in response to obtaining information from the card 2218, when an applicator is connected to the system, selection of a program, etc. The routine can authenticate each component that is connected to the system. The routine may employ various mechanisms for authenticating components. As an example, one such mechanism is a concept known as trusted computing. When using the trusted computing concept, transactions between every component (e.g., card, applicator, umbilical, etc.) are secured, such as by using encryption, digital signatures, digital certificates, or other security techniques. When a component connects to the system, the component may be queried (e.g., challenged) for its authentication credentials, such as a digital certificate. The component could then provide its authentication credentials in response to the query. Another component that sent the query can then verify the authentication credentials, such as by verifying a one-way hash value, a private or public key, or other data that can be used to authenticate the component. The authentication credentials or authentication function can be stored in a secure processor memory, or in other secure memory (e.g., onboard memory of the applicator) that is associated with the component that is to be authenticated. In some embodiments, a querying component can provide a key to a queried component, and the queried component can respond by employing an authentication function, such as a one-way hash function, to produce a responsive key, such as a one-way hash value. The queried component can then respond to the query by providing the produced responsive key to the querying component. The two components can thus authenticate each other to establish a secure communications channel. Further communications between the authenticated components can transpire over the secure communications channel by using encrypted or unencrypted data. Various known encryption techniques can be employed.
The various components described herein can be provided as a kit for treatment of a subject. A kit can include a plurality of applicators (e.g., two or more of the applicators described with respect to any of
The method 2300 begins at step 2302 with applying an applicator template to the subject. The applicator template can be any of the embodiments described herein (e.g., with respect to any of
At step 2304, if the applicator template fits the target region when applied to the subject, the applicator corresponding to the applicator template is selected for use in the treatment procedure. If, however, the applicator template does not fit the target region, the physician can select a different applicator template and check the fit of the new template against the subject's body. This process can be repeated multiple times until an appropriate applicator is selected. As previously discussed, the treatment systems herein can include a kit or array of multiple applicators having different dimensions, such that the physician can tailor the treatment to each patient's unique anatomy. In other embodiments, however, steps 2302 and/or 2304 are optional and may be omitted.
At step 2306, the selected applicator is applied to the subject's skin. The applicator can be any of the embodiments described herein (e.g., with respect to any of
At step 2308, a vacuum is drawn to pull tissue into a tissue-receiving cavity of the applicator. The subject's skin can be drawn toward a temperature-controlled surface of a treatment cup of the applicator while air-egress features maintain airflow paths for removing air from the cavity. As discussed above, to draw the vacuum, a vacuum system (e.g., pressurization device 123 of
In some treatments, tissue can be drawn into the tissue-receiving cavity such that substantially all of the skin surface within the cavity overlies the temperature-controlled surface. For example, 90%, 95%, 99%, or more of the surface area of the skin located in the cavity can overlie the temperature-controlled surface. Optionally, the number and dimensions of the air-egress features can be increased or decreased to achieve desired thermal contact for a particular vacuum level. After a sufficient amount of tissue fills most or all of the cavity, the pressure level can be controlled to comfortably hold the tissue.
In other embodiments, step 2308 may be omitted, e.g., if the applicator is a non-vacuum applicator (e.g., as described with respect to
At step 2310, the applicator can extract heat from the tissue. After the skin is in thermal contact with the temperature-controlled surface of the applicator, heat can be extracted from the subject's tissue to cool the tissue by an amount sufficient to be biologically effective in selectively damaging and/or reducing the subject's subcutaneous lipid-rich cells. As discussed above, the applicator can include a treatment cup (e.g., cup 156 of
In contrast to invasive procedures in which coolant is injected directly into targeted tissue, the temperature-controlled surface can conductively cool tissue to produce a desired temperature in target tissue without bruising, pain, or other problems caused by injections and perfusion of injected fluid. For example, perfusion of injected fluid can affect the thermal characteristics of the treatment site and result in undesired temperature profiles. As such, the non-invasive conductive cooling provided by the applicator can be more accurate than invasive procedures that rely on injecting fluids. Targeted tissue can be cooled from about −20° C. to about 10° C., from about 0° C. to about 20° C., from about −15° C. to about 5° C., from about −5° C. to about 15° C., or from about −10° C. to about 0° C. In one embodiment, a liner can be kept at a temperature less than about 0° C. to extract heat from subcutaneous lipid-rich cells such that those cells are selectively reduced or damaged.
It may take a few days to a few weeks, or longer, for the adipocytes to break down and be absorbed. A significant decrease in fat thickness may occur gradually over 1-3 months following treatment. Additional treatments can be performed until a desired result is achieved. For example, one or more treatments can be performed to substantially reduce (e.g., visibly reduce) or eliminate targeted tissue. In such embodiments, the method 2300 can be repeated multiple times to achieve the desired treatment result.
Optionally, the method 2300 can include additional steps or processes not illustrated in
As another example, the method 2300 can include applying a cryoprotectant between the applicator and the skin. The cryoprotectant can be a freezing point temperature depressant that may additionally include a thickening agent, a pH buffer, a humectant, a surfactant, and/or other additives. The temperature depressant may include, for example, polypropylene glycol (PPG), polyethylene glycol (PEG), dimethyl sulfoxide (DMSO), or other suitable alcohol compounds. In a particular embodiment, a cryoprotectant may include about 30% polypropylene glycol, about 30% glycerin (a humectant), and about 40% ethanol. In another embodiment, a cryoprotectant may include about 40% propylene glycol, about 0.8% hydroxyethylcellulose (a thickening agent), and about 59.2% water. In a further embodiment, a cryoprotectant may include about 50% polypropylene glycol, about 40% glycerin, and about 10% ethanol. Other cryoprotectants or agents can also be used and can be carried by a cotton pad or other element. U.S. application Ser. No. 14/610,807 is incorporated by reference in its entirety and discloses various compositions that can be used as cryoprotectants.
In some embodiments, the method 2300 can include monitoring a temperature of the patient's tissue. It will be appreciated that while a region of the body has been cooled or heated to the target temperature, in actuality that region of the body may be close but not equal to the target temperature, e.g., because of the body's natural heating and cooling variations. Thus, although the applicator may attempt to heat or cool the target tissue to the target temperature or to provide a target heat flux, sensors may be used to measure a sufficiently close temperature or heat flux. If the target temperature or heat flux has not been reached, operation of the cooling unit can be adjusted to change the heat flux to maintain the target temperature or “set-point” selectively to affect targeted tissue. When the prescribed segment duration expires, the next treatment profile segment can be performed.
The sensors can be temperature sensors, such as thermistors, positioned to detect temperature changes associated with warm tissue being drawn into and/or located in the cup. A control unit (e.g., control unit 106 of
Sensor feedback can be collected in real-time and used in concert with treatment administration to efficaciously target specific tissue. The sensor measurements can also indicate other changes or anomalies that can occur during treatment administration. For example, an increase in temperature detected by the sensors can indicate either a freezing event at the skin or movement of the applicator. An operator can inspect the subject's skin and/or applicator in response to a detected increase in temperature. Methods and systems for collection of feedback data and monitoring of temperature measurements are described in commonly assigned U.S. Pat. No. 8,285,390.
As illustrated in
In operation, the input module 2414 accepts an operator input 2424 via the one or more input devices, and communicates the accepted information or selections to other components for further processing. The database module 2416 organizes records, including patient records, treatment data sets, treatment profiles and operating records and other operator activities, and facilitates storing and retrieving of these records to and from a data storage device (e.g., internal memory 2406, an external database, etc.). Any type of database organization can be utilized, including a flat file system, hierarchical database, relational database, distributed database, etc.
In the illustrated example, the process module 2418 can generate control variables based on sensor readings 2426 from sensors and/or other data sources, and the output module 2420 can communicate operator input to external computing devices and control variables to the controller. The display module 2422 can be configured to convert and transmit processing parameters, sensor readings 2426, output signals 2428, input data, treatment profiles and prescribed operational parameters through one or more connected display devices, such as a display screen, touchscreen, printer, speaker system, etc.
In various embodiments, the processor 2404 can be a standard central processing unit or a secure processor. Secure processors can be special-purpose processors (e.g., reduced instruction set processor) that can withstand sophisticated attacks that attempt to extract data or programming logic. The secure processors may not have debugging pins that enable an external debugger to monitor the secure processor's execution or registers. In other embodiments, the system may employ a secure field programmable gate array, a smartcard, or other secure devices.
The memory 2406 can be standard memory, secure memory, or a combination of both memory types. By employing a secure processor and/or secure memory, the system can ensure that data and instructions are both highly secure and sensitive operations such as decryption are shielded from observation. In various embodiments, the memory 2406 can be flash memory, secure serial EEPROM, secure field programmable gate array, or secure application-specific integrated circuit. The memory 2406 can store instructions for causing the applicators to cool/heat tissue, pressurization devices to draw a vacuum, or other acts disclosed herein. Vacuum levels can be selected based on characteristics of the applicator, airflow features, and/or treatment site. In one embodiment, the memory 2406 stores instructions executable by the controller 2400 for the thermal device to sufficiently cool conductive cups disclosed herein such that vacuum applicators non-invasively cool the subcutaneous lipid-rich cells to a desired temperature, such as a temperature less than about 0° C. In some embodiments, the memory 2406 can contain liner installation or draw instructions for causing the liner to be drawn into the applicator, tissue draw instructions for causing the applicator to draw tissue into the applicator, treatment instructions for heating/cooling tissue, tissue release instructions for releasing tissue, and instructions for monitoring treatment. For example, the liner installation or draw instructions can be executed by the controller 2400 to command a vacuum system to suck the liner against a conductive surface of the conductive cup.
The input/output device 2408 can include, without limitation, a touchscreen, a keyboard, a mouse, a stylus, a push button, a switch, a potentiometer, a scanner, an audio component such as a microphone, or any other device suitable for accepting user input and can also include one or more video monitors, a medium reader, an audio device such as a speaker, any combination thereof, and any other device or devices suitable for providing user feedback. For example, if an applicator moves an undesirable amount during a treatment session, the input/output device 2408 can alert the subject and/or operator via an audible alarm. The input/output device 2408 can be a touch screen that functions as both an input device and an output device.
Optionally, the controller 2400 can include a control panel with visual indicator devices or controls (e.g., indicator lights, numerical displays, etc.) and/or audio indicator devices or controls. The control panel may be a component separate from the input/output device 2408, may be integrated with the applicators, may be partially integrated with one or more other devices, may be in another location, and so on. In alternative embodiments, the controller 2400 can be contained in, attached to, or integrated with the applicators. Further details with respect to components and/or operation of applicators, control modules (e.g., treatment units), and other components may be found in commonly-assigned U.S. Patent Publication No. 2008/0287839.
The controller 2400 can include any processor, Programmable Logic Controller, Distributed Control System, secure processor, and the like. A secure processor can be implemented as an integrated circuit with access-controlled physical interfaces; tamper resistant containment; means of detecting and responding to physical tampering; secure storage; and shielded execution of computer-executable instructions. Some secure processors also provide cryptographic accelerator circuitry. Suitable computing environments and other computing devices and user interfaces are described in commonly assigned U.S. Pat. No. 8,275,442, entitled “TREATMENT PLANNING SYSTEMS AND METHODS FOR BODY CONTOURING APPLICATIONS,” which is incorporated herein in its entirety by reference.
The treatment systems, applicators, and methods of treatment can be used reduce adipose tissue or treat subcutaneous tissue, acne, hyperhidrosis, wrinkles, structures (e.g., structures in the epidermis, dermis, subcutaneous fat, muscle, nerve tissue, etc.), and so on. Systems, components, and techniques for reducing subcutaneous adipose tissue are disclosed in U.S. Pat. No. 7,367,341 titled “METHODS AND DEVICES FOR SELECTIVE DISRUPTION OF FATTY TISSUE BY CONTROLLED COOLING” to Anderson et al., U.S. Patent Publication No. US 2005/0251120 titled “METHODS AND DEVICES FOR DETECTION AND CONTROL OF SELECTIVE DISRUPTION OF FATTY TISSUE BY CONTROLLED COOLING” to Anderson et al., and U.S. Patent Publication No. 2007/0255362 titled “CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR IMPROVED COOLING OF SUBCUTANEOUS LIPID-RICH CELLS,” the disclosures of which are incorporated herein by reference in their entireties. Vacuum applicators can stretch, stress, and/or mechanically alter skin to increase damage and fibrosis in the skin, affect glands, control freeze events (including initiating freeze events), etc. Methods for cooling tissue and related devices and systems in accordance with embodiments of the present invention can at least partially address one or more problems associated with conventional technologies as discussed above and/or other problems whether or not such problems are stated herein.
Unless the context clearly requires otherwise, throughout the description, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in a sense of “including, but not limited to.” Words using the singular or plural number also include the plural or singular number, respectively. Use of the word “or” in reference to a list of two or more items covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list. Furthermore, the phrase “at least one of A, B, and C, etc.” is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.).
Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.
Any patents, applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the described technology can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments. These and other changes can be made in light of the above Detailed Description. While the above description details certain embodiments and describes the best mode contemplated, no matter how detailed, various changes can be made. Implementation details may vary considerably, while still being encompassed by the technology disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the technology should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the technology with which that terminology is associated.
This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/065,946, filed Aug. 14, 2020, entitled “MULTI-APPLICATOR SYSTEM AND METHOD FOR BODY CONTOURING,” which is incorporated herein by reference in its entirety. The following commonly assigned U.S. patent applications and U.S. patents are incorporated herein by reference in their entireties: U.S. Patent Publication No. 2008/0287839 entitled “METHOD OF ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS AND TREATMENT APPARATUS HAVING AN ACTUATOR”; U.S. Pat. No. 6,032,6175 entitled “FREEZING METHOD FOR CONTROLLED REMOVAL OF FATTY TISSUE BY LIPOSUCTION”; U.S. Patent Publication No. 2007/0255362 entitled “CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR IMPROVED COOLING OF SUBCUTANEOUS LIPID-RICH CELLS”; U.S. Pat. No. 7,854,754 entitled “COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”; U.S. Pat. No. 8,337,539 entitled “COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”; U.S. Patent Publication No. 2008/0077201 entitled “COOLING DEVICES WITH FLEXIBLE SENSORS”; U.S. Pat. No. 9,132,031 entitled “COOLING DEVICE HAVING A PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A PREDETERMINED COOLING PROFILE”; U.S. Patent Publication No. 2009/0118722, filed Oct. 31, 2007, entitled “METHOD AND APPARATUS FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS OR TISSUE”; U.S. Patent Publication No. 2009/0018624 entitled “LIMITING USE OF DISPOSABLE SYSTEM PATIENT PROTECTION DEVICES”; U.S. Pat. No. 8,523,927 entitled “SYSTEM FOR TREATING LIPID-RICH REGIONS”; U.S. Patent Publication No. 2009/0018625 entitled “MANAGING SYSTEM TEMPERATURE TO REMOVE HEAT FROM LIPID-RICH REGIONS”; U.S. Patent Publication No. 2009/0018627 entitled “SECURE SYSTEM FOR REMOVING HEAT FROM LIPID-RICH REGIONS”; U.S. Patent Publication No. 2009/0018626 entitled “USER INTERFACES FOR A SYSTEM THAT REMOVES HEAT FROM LIPID-RICH REGIONS”; U.S. Pat. No. 6,041,787 entitled “USE OF CRYOPROTECTIVE AGENT COMPOUNDS DURING CRYOSURGERY”; U.S. Pat. No. 8,285,390 entitled “MONITORING THE COOLING OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE TISSUE”; U.S. Pat. No. 8,275,442 entitled “TREATMENT PLANNING SYSTEMS AND METHODS FOR BODY CONTOURING APPLICATIONS”; U.S. patent application Ser. No. 12/275,002 entitled “APPARATUS WITH HYDROPHILIC RESERVOIRS FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS”; U.S. patent application Ser. No. 12/275,014 entitled “APPARATUS WITH HYDROPHOBIC FILTERS FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”; U.S. Pat. No. 8,603,073 entitled “SYSTEMS AND METHODS WITH INTERRUPT/RESUME CAPABILITIES FOR COOLING SUBCUTANEOUS LIPID-RICH CELLS”; U.S. Pat. No. 8,192,474 entitled “TISSUE TREATMENT METHODS”; U.S. Pat. No. 8,702,774 entitled “DEVICE, SYSTEM AND METHOD FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”; U.S. Pat. No. 8,676,338 entitled “COMBINED MODALITY TREATMENT SYSTEMS, METHODS AND APPARATUS FOR BODY CONTOURING APPLICATIONS”; U.S. Pat. No. 9,314,368 entitled “HOME-USE APPLICATORS FOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS VIA PHASE CHANGE COOLANTS, AND ASSOCIATED DEVICES, SYSTEMS AND METHODS”; U.S. Publication No. 2011/0238051 entitled “HOME-USE APPLICATORS FOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS VIA PHASE CHANGE COOLANTS, AND ASSOCIATED DEVICES, SYSTEMS AND METHODS”; U.S. Publication No. 2012/02317023 entitled “DEVICES, APPLICATION SYSTEMS AND METHODS WITH LOCALIZED HEAT FLUX ZONES FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”; U.S. Pat. No. 9,545,523 entitled “MULTI-MODALITY TREATMENT SYSTEMS, METHODS AND APPARATUS FOR ALTERING SUBCUTANEOUS LIPID-RICH TISSUE”; U.S. Patent Publication No. 2014/0277302 entitled “TREATMENT SYSTEMS WITH FLUID MIXING SYSTEMS AND FLUID-COOLED APPLICATORS AND METHODS OF USING THE SAME”; U.S. Pat. No. 9,132,031 entitled “COOLING DEVICE HAVING A PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A PREDETERMINED COOLING PROFILE”; U.S. Pat. No. 8,285,390 entitled “MONITORING THE COOLING OF SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE TISSUE”; U.S. Patent Publication No. 2016/0054101 entitled “TREATMENT SYSTEMS, SMALL VOLUME APPLICATORS, AND METHODS FOR TREATING SUBMENTAL TISSUE”; U.S. Patent Publication No. 2018/0310950 entitled “SHALLOW SURFACE CRYOTHERAPY APPLICATORS AND RELATED TECHNOLOGY”; U.S. Patent Publication No. 2020/0038234 entitled “METHODS, DEVICES, AND SYSTEMS FOR IMPROVING SKIN CHARACTERISTICS”; and U.S. patent application Ser. No. 16/557,814 entitled COMPOSITIONS, TREATMENT SYSTEMS, AND METHODS FOR FRACTIONALLY FREEZING TISSUE.”
| Number | Date | Country | |
|---|---|---|---|
| 63065946 | Aug 2020 | US |
