Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/02—Compresses or poultices for effecting heating or cooling
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F2007/0086—Heating or cooling appliances for medical or therapeutic treatment of the human body with a thermostat
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F2007/0093—Heating or cooling appliances for medical or therapeutic treatment of the human body programmed
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/02—Compresses or poultices for effecting heating or cooling
  • A61F2007/0282—Compresses or poultices for effecting heating or cooling for particular medical treatments or effects
  • A61F2007/0284—Treatment of stings or bites
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/02—Compresses or poultices for effecting heating or cooling
  • A61F2007/0282—Compresses or poultices for effecting heating or cooling for particular medical treatments or effects
  • A61F2007/0285—Local anaesthetic effect
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/02—Compresses or poultices for effecting heating or cooling
  • A61F2007/0282—Compresses or poultices for effecting heating or cooling for particular medical treatments or effects
  • A61F2007/029—Fat cell removal or destruction by non-ablative heat treatment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/02—Compresses or poultices for effecting heating or cooling
  • A61F2007/0295—Compresses or poultices for effecting heating or cooling for heating or cooling or use at more than one temperature
  • A61F2007/0296—Intervals of heating alternated with intervals of cooling

Definitions

• the present invention relates to a method and to an apparatus for heat and cold treatment of an animal or human body for medical and nonmedical purposes.
• the present invention concerns so-called cryokinetic apparatuses in particular.
• cryokinetic apparatuses which are used in order to conductively cool and/or heat part of a human body. They may as well provide a combination of both conductive cold and heat therapy during the treatment, (treatment refers to both medical and non-medical use of the apparatus in this context) Certain medical experts believe that such an apparatus might have a negative effect since it could cause the suppression of the inflammatory response of the body, through the use of cold temperatures.
• Such an apparatus might cause a vasoconstriction, meaning that the blood vessels are locally narrowed. This could result in an increased blood pressure or an insufficient blood flow through small local structures of the body.
• Applying lower temperatures to the target tissue through conductive cooling, using ice or cold (gel) packs, or combinations of ice and water pumped through a pad will result in a reduction in tissue metabolism as well, but will also result in a drop in blood flow, which may not be beneficial to tissue recovery/healing.
• Increasing cooling therapy times to ensure cooling deeper into the tissue of the affected area) there is additional concern of a loss of circulation thereby preventing the supply to the tissue from oxygen and the possibility to remove waste products, which have a negative effect on the body's natural healing elements of the inflammatory response.
• recirculating "chillers” more advanced or recirculating coolers (less advanced), which typically have a closed loop or semi closed fluid system.
• a certain tank space is required to ensure that the pump circulation system can run efficiently. This, however, requires an overflow system.
• chillers may have an active electronic cooling and heating mechanism. Additionally the “active cooling” may be achieved by simply adding ice into the device, and mixing this with water to “generate cold fluid". In combination with an electronic heating coil they will attempt to maintain or warm up the overall fluid temperature, however once the fluid is too warm, these systems need to "re-charge the cooling” by adding additional ice back into the device, thus an operator-interface is required to continue to cool the fluid down again. This leads to non standardization of temperatures during the cryotherapy treatment, as well reproducibility is not possible.
• controller is implemented or programmed to execute a predefined modulation scheme, said modulation scheme comprising a cooling phase during which the cooling system is operated in order to reduce the temperature of the fluid and a heating phase during which the heating system is operated in order to increase the temperature of the fluid.
• modulation scheme comprising a cooling phase during which the cooling system is operated in order to reduce the temperature of the fluid and a heating phase during which the heating system is operated in order to increase the temperature of the fluid.
• a closed neutral pressure system might be employed in order to avoid the disadvantages of existing systems.
• the closed neutral pressure system in this case might comprise an overflow tank for storing fluid.
• the apparatus is operated via a controller and it is implemented so as to steer the apparatus through cold and warm - time specific slopes represented by temperature-time curves in a temperature-time diagram.
• These cold and warm - time specific slopes are herein referred to as temperature modulations and the pre-defined or programmed schemes are referred to as modulation schemes.
• the fluid system of the apparatus might comprise a by-pass function which, when activated, ensures that the fluid flow through the pad is disconnected from the fluid tank.
• the removal of heat from the body is achieved by varying the pump speed of the apparatus and/or by varying the throughput of the fluid system.
• the fluid velocity can be decreased and increased as prescribed by the controller of the apparatus.
• An increase of the fluid velocity leads to an increase of the overall heat transfer.
• a decrease of the overall heat transfer is observed when the fluid velocity is reduced.
• the apparatus is implemented so that a temperature modulation is achieved by a combination of active cooling or heating with a variation of the pump speed, or by a combination of active cooling or heating with a variation of the throughput of the fluid system, or by a combination of active cooling or heating with a variation of the pump speed and with a variation of the throughput.
• the apparatus has a special function, which enables a patient to intervene, e.g. by pressing a button.
• the respective special function is preferably implemented so that by a human intervention, the modulation scheme is temporarily adapted.
• This adaptation of the modulation scheme could for instance cause a small increase of the temperature of the fluid running through the bladder of the pad.
• the increase of the temperature is predefined (e.g. defined by means of software of the apparatus) to be in a range between 1 and 5°C.
• Preferred embodiments of the invention offer a special function where by means of a human interaction with the apparatus, e.g.
• Preferred embodiments of the invention could offer a special function where instead of increasing the temperature the temperature can be lowered (e.g. in 1°C steps). This special function too might be designed so that it works only within a given temperature range to prevent misuse.
• Preferred embodiments of the invention could also be implemented so that by human intervention (e.g. by pressing a button) the baseline of a modulation scheme can be shifted towards warmer or towards colder temperatures. This would give the patient or user the possibility to influence the chosen modulation scheme within predefined boundaries (e.g. within the mild temperature band) so that the patient feels more comfortable. This in turn makes sure that fewer treatment cycles are stopped or interrupted because the patient does not feel comfortable. If a patient can increase the temperature but allows the apparatus to continue within the modulation temperature band scheme (e.g. with the predefined sequence of pyramids) then the patient still gets the benefits of the thermal pyramid modulations.
• predefined boundaries e.g. within the mild temperature band
• the apparatus is designed so that under no circumstances the temperature at the bladder of the pad can go outside the mild temperature range to ensure that in case of misuse or faulty operation the patient is always protected against very low or very high temperatures.
• Preferred embodiments of the invention enable the user or operator of the apparatus to select from a catalogue of pre-set indication- based modulations schemes to deliver standardized accurate temperatures and times, ensuring the safe, comfortable and effective application of the invention.
• Preferred embodiments of the invention comprise a machine-user interface, which is straightforward and simple to use.
• the machine- user interface comprises a graphical user interface where at least two different modulation schemes are presented and where the users or operator is asked to choose one modulation scheme.
• the apparatus in addition to choosing a desired modulation scheme, the apparatus also asks the user to enter one or more of the following data/parameter:
• preferred embodiments of the apparatus will make adaptations to the modulation scheme selected or the apparatus is going to propose a suitable modulation scheme so that the user only has to accept the proposal by using the machine-user interface.
• circumferential cooling pads are employed that conform to the affected body region. Such pads, together with the inventive modulation schemes, allow for efficient, circumferential cooling of body parts (e.g. of a joint).
• circumferential cooling pads are employed. These pads are connectable to the apparatus so as to be able to establish a fluid flow. These pads are, when being connected, part of the fluid system of the apparatus.
• circumferential cooling pads offer good contact to the skin and some level of static compression.
• all embodiments of the invention comprise circumferential cooling pads, preferably encased in a foam wrap, which have straps or belts, in order to provide a good contact to the skin and some level of static compression.
• circumferential cooling pads one can ensure full modulation in accordance with one of the inventive modulation schemes, covering greater tissue area, and increasing thermodynamic transfer of heat removal. This ensures the reduction of a swelling and reduction of pain more quickly, and deeper cooling over time of the tissue.
• the circumferential cooling pads of all embodiments may be designed so that a pressure neutral closed loop is provided for optimising the cooling efficiency, flow via a gravity fed overflow fluid system.
• the cooling pads are designed as single use pads. This is more hygienic than pads, which are used by a number of different patients.
• the cooling pads comprise a bladder (e.g. a plastic bladder) which can be separated from a backing of the pad.
• the bladder can be designed as single use bladder and/or as a patient/user specific bladder.
• the plastic bladder of all embodiments may have a non-woven layer attached to it as well, which may provide additional patient comfort, and absorb potential moisture caused from condensation between the bladder and the skin.
• all embodiments use a foam wrap as backing of the pad.
• the apparatus preferably in all embodiments comprises a thermo-electric system, for generating heat.
• This system is herein referred to as active heating system.
• a re-fillable block might be used in connection with all embodiments. Such a re-fillable block can turn into ice easily and quickly. It can be stored and put to use as needed. The re-fillable block can be put into a main tank or in an auxiliary tank of the apparatus in order to cool down the fluid inside the fluid system more quickly. The use of a re-fillable block is optional.
• the re-fillable block contains a chemical in order to keep the content in a liquid slush form.
• the re-fillable block is color coated so that its outer surface tells the user or operator when the block is sufficiently cooled down.
• the tank or fluid system contains an anti-calc solution to prevent calcareous deposits.
• the tank or fluid system contains an anti-microbial fluid or an anti-microbial material (e.g. a silver stick) to prevent microbial growth in the components of the apparatus.
• an anti-microbial fluid or an anti-microbial material e.g. a silver stick
• a suitable level of glycol or similar concentrate is added to the fluid to ensure a constant concentration of which prevents a blocking of the fluid flow.
• a long nozzle is provided, which reaches into the bottom of the tank. This helps to increase the efficiency of the apparatus.
• the apparatus of all embodiments is not using an ice- based cooling approach. It rather uses a gas for cooling purposes (as described here), or a thermal electric Peltier element for cooling purposes.
• the apparatus of the invention offers more controlled mild and continuous long treatment times as compared to conventional systems.
• the treatment schemes and according modulation schemes of the invention provide for less extreme temperatures and for a longer treatment time (in the range of ten minutes and more). Due to this, body fat can be completely penetrated and painful cold and hot temperatures at the skin right under the pad can be avoided. Longer controlled mild cooling times can be more beneficial to the patient most importantly allowing deeper cooling of the joint fluid, and or surrounding tissue, or muscle tissue.
• all embodiments of the invention are designed so that the temperature range of the pad is between 5°C and 42°C.
• preferred temperature range of the fluid circulating through the pad is between 8°C and 38°C. Most suitable is a fluid temperature range circulating through the pad between 8°C and 17°C, described as mild cooling.
• a preferred temperature range of the fluid circulating through the pad is between 34°C and 42°C. Most suitable is a fluid temperature range circulating through the pad between 38°C and 42°C, described as mild heating.
• the apparatus of all embodiments might be designed to be used as mild cooling system and/or as mild heating system.
• the present invention is based on a systematic review and analysis of trials on the efficacy of modulations schemes using thermo pyramids in a mild cooling temperature band.
• the current evidence clearly supports the routine use of an apparatus, as claimed, which is designed to apply modulation schemes using thermo pyramids in a mild cooling temperature band.
• the present invention is based on a systematic review and analysis of trials on the efficacy of modulations schemes using thermo pyramids in a mild heating temperature band.
• the goal of heat treatments is in increasing circulation, accelerate healing, and increase soft tissue extensibility (used by athletes in pre-warm up as an example). Heating influences hemodynamic, metabolic and neuromuscular processes.
• the following effects are examples of the effects of heating : diminished pain perception, reduced muscle spasms, reduction of intracellular edema, triggering of collagen synthesis, Activtion of fibroblast growth factors, increasing macrophage activity, extension of collagen fibers in tendons, increased metabolism, increased blood flow and relaxation.
• Examples of Indications using conductive are: arthritis, back pain, chronic pain, joint contractures, soft tissue and repetitive stress injuries.
• the goal is to achieve intramuscular temperature of at minimum 40°C in order to achieve the effects of muscle lengthening and increase in tissue metabolism, deep tissue temperature, and blood flow.
• the heat treatment band of between 38°C and 42°C will follow the same characteristics with respect to Down slopes (DSx), Horizontal slopes (HSx) and Up slopes (USx) as the inventive treatment in the mild cooling band.
• the focus of this invention is to focus on the definition of providing thermal modulations for cold treatments, and for providing thermal modulations for heat treatments, using an active cooling and heating apparatus.
• an ideal therapeutic skin temperature for cooling which can achieve the desired effects of pain reduction, decreased inflammation and cell metabolism, is defined to be in the range between 10 to 15°C, with an optimal temperature of the skin temperature around 13-15°C.
• the inventive apparatus is able to achieve beneficial results without the risk of skin or nerve damage that is seen with colder temperatures such as with the use of ice or cold packs.
• the invention is based on the development of pre-set protocols (different modulation schemes) with region, body and/or patient specific temperatures and/or other data/parameters that are integrated into the apparatus.
• the function of the inventive apparatus and the effect of the inventive modulation schemes have been assessed by using Laser Doppler flowmetry.
• the Laser Doppler flowmetry is a non-invasive technique that is used to assess blood flow and blood flow velocity in the area of interest. It has been demonstrated that the blood flow circulation is maintained when using the inventive modulation schemes while being able to locally reduce the temperature of the respective body part to the desired range within the mild band.
• lymphatic drainage is an essential process in the decrease of swelling. It has been shown that, when applying intensive cold therapy (skin temp ⁇ 10°C) it is possible to constrict lymphatic vessels surrounding the injury site and therefore limit the evacuation of the swelling.
• the invention thus employs temperature modulation schemes with up- and down-ramps, combined with horizontal slopes at either end of the up or down phase as part of the thermal pyramid scheme.
• the up-ramps are herein referred to as Up slopes or heating phase (USx) and the down-ramps are referred to as Down slopes or cooling phase (DSx), and the horizontal ramps (which technically move towards a constant temperature) are referred as horizontal slopes or maintenance phase (HSx).
• the modulation schemes inside the mild band enable the apparatus to keep the intra-articular temperatures in a physiological range so that the inflammatory process is not completely altered or negatively affected. It is important (e.g. for a rehabilitation process) that the main inflammatory cells can carry out their function.
• the modulation schemes of the invention have been found to reduce pain and analgesic consumption as well as increase range of motion.
• the modulation schemes of the invention can also reduce inflammation following tissue trauma or as a result of disease processes like arthritis.
• the modulation schemes of the invention result in a local vasoconstriction and have been shown to decrease microcirculation by up to 60%. This results in less extravasation of blood into surrounding tissues, local inflammation and edema production.
• the apparatus when used with the pre-defined modulation schemes, is reported to lead to a significant reduction in post-operative blood loss, for instance. o All patients sensed the temperatures as applied by the inventive apparatus as comfortable (meaning not too cold, and not too warm, but exactly right). None of the patients of a study needed additional pain medication. There were no side-effects during the usage of the inventive apparatus.
• a continuous controlled active modulation as described and claimed herein, is going to become an essential part of the standard of care and will be used in many medical and non-medical fields.
• the cooling phase (DSx) and/or the heating phase (USx) of all embodiments have/has a duration of at least 2 minutes and a maximum duration of 10 minutes
• the horizontal maintenance phase (HSx) of all embodiments have /has a duration of at least 10 minutes and a maximum duration of 16 minutes.
• a cool ratio (degrees per minute) using a small bladder of the pad is provided which is between 1 and 2°C/min.
• a warming ratio (degrees per minute) using a small bladder of the pad is provided which is between 1 and 3°C/min.
• all embodiments of the invention have a tank with a fluid capacity between 1 liter and 10 liter.
• all embodiments of the invention have a digital display and touch pad or another human-machine interface in order to enable a user or operator to choose a predefined modulation scheme and/or to define a modulation scheme for use by the apparatus.
• operation modes and according modulation schemes with times extending 15 minutes are provided.
• the treatment can run for several hours during an acute phase. Shorter treatment times can be run from 25 minutes upwards.
• the modulation scheme is designed so that the warm or hot temperature does not stay at one given temperature level.
• the modulation scheme preferably provides for a slow change of the temperature so that the patient can feel this change (thus stimulating neurosensors, nerve conduction).
• a specific treatment scheme is employed which drives the apparatus to modulate in a controlled manner through a series of cold and warm slopes, with three unique intervals.
• all embodiments offer modulation schemes with three unique intervals.
• thermo pyramids preferably comprises
• thermo pyramids give the patient additional comfort and it causes less stress on the body. Additionally these longer time flat horizontal slopes provide both on the lower temperature or upper temperature of the thermal pyramid temperature maintenance of the thermodynamic conductivity, and heat transfer.
• a total treatment protocol therefore of say 25 minutes with a regional skinfold of 20 mm may be sufficient versus a skinfold between 30-40 mm which require 60 minutes of cooling (this was measured and described in a third-party publication with ice bags to obtain a 7°C intramuscular temperature reduction. Minutes /length of staying in this temperature band (s) will serve as an indication of the difference in the time to reach target temperature reduction.
• Sustaining the horizontal lower cooling band (HS2, HS4, HS6, HS8) is designed to reduce cooling of tissue temperature, reduction of metabolism through reduction of blood velocity, followed by sloping upwards (heating) and maintaining upper temperature horizontal slopes ( HS1, HS3, HS5, HS7, thus maintaining the circulation through the warmer temperature band, and by maintaining this temperature over time ensures the required heat transfer, to desired tissue depth.
• the apparatus of the invention has to be designed so that it is able to ensure that the temperature of the fluid closely follows the up and down slopes of the pre-defined modulation scheme.
• the heating and cooling capacity has to be sufficient and the heating and cooling rates have to be fast enough so that the apparatus is able to react quickly.
• thermo pyramids Preferably, during such a treatment where thermo pyramids are used, optional warming spikes are added, to help patient comfort.
• Such warming spikes should not increase more than 10°C, during any one time phase, to avoid temperature sensor shock.
• cooling spikes may be added. Such optional cooling spikes should not decrease more than 10°C during any one cooling phase.
• the pyramids may vary in time and temperature, to achieve the expected outcome. In some instances, more cooler milder temperatures may be desired during an acute phase, as opposed to less cooler milder temperatures during patient rehabilitation phase.
• none of the ranges (e.g. the individual slopes) of the pyramids is longer than 15 minutes.
• the pyramids segments can be shortened or extended depending on achieved expected outcome.
• the pyramids cycles can be "shifted" upwards (to warmer phase) if patient is too cold (within the mild zone).
• the pyramids cycles can be "shifted" downwards (to colder phase) if are required.
• the pyramids cycles can be shifted based on body parts to be treated, in which there is less known skin thickness and skin fat.
• the pyramid cycles optionally may be shifted based on gender (male have thicker skin, than females) and/or age and/or other data/parameters. Elderly patients from experience tend to be more effective by colder temperatures.
• the pyramid cycles optionally may be shifted based on the physical condition of patient (body weight, intensity of trauma, size of the joint or region, blood supply, ability to cool circumferentially, sensory innervation).
• the mild (cold) slopes of the invention help to reduce the blood velocity and the local blood hemoglobin saturation. This reduction reduces the risk of secondary hypoxia damage of the injured area, by reducing the amount of oxygen required to the healthy cells, thus avoiding cell death.
• the modulation schemes of the invention stay in the mild temperature bands in order to avoid the disadvantages of known cryokinetic apparatuses, and temperature schemes they implement, such as contrast cooling, which have short steep cold or warmer slopes in short periods of time, short and long term use of cold ice packs, or ice cold systems, and the known safety concerns with them. Due to the intermittent nature of all preferred modulation schemes of the invention the blood flow and blood velocity are maintained thus ensuring circulation is maintained which has a positive effect on the inflammatory response, (for both cooling and heating treatments)
• the modulation schemes of all preferred embodiments of the invention are designed to mimic a mechanical compression curve where pressure is locally applied to the human body followed by a phase where the pressure is released.
• the modulation schemes of the invention avoid spikes and rebound effects.
• This rebound effect is a negative reaction from extreme cold, as the blood vessels dilate, the body reacts as if it is freezing and responds by pumping more warm blood to the afflicted area. This, in turn, may increase swelling and/or bruising, and increase bleeding. It as well can be referenced as a reflex reaction occurrence, known as "Hunting effect and/or Hunting Reaction" where the blood vessels dilate and blood is again pumped into the injured area, potentially causing further bleeding and swelling.
• the milder temperature band between 5°C and 42°C provided by the inventive apparatus and used by the inventive method ensures no cold pain and no reduction of lymphatic drainage.
• the body does not show rebound effects.
• the apparatus comprises a fluid pump, which either sits on top of a fluid reservoir (called tank) and which has an aspiration nozzle or hose which sits inside the fluid.
• a pump is employed which is submerged inside the fluid in the tank, or a pump is connected to the bottom side of a tank.
• the apparatus of all embodiments comprises a recirculating loop (call this a recirculating chiller) which provides for a controlled cooling and heating in accordance with a predefined modulation scheme.
• a recirculating loop (call this a recirculating chiller) which provides for a controlled cooling and heating in accordance with a predefined modulation scheme.
• the apparatus of all embodiments comprises a computer being connectable to the apparatus.
• the computer's CPU serves as controller, which controls the execution or implementation of a modulation scheme.
• pads do not have to be prefilled with water before being connected to the fluid system of the apparatus. This risk of bacterial contamination is thus reduced.
• the inventive apparatus can also be used to support or provide pre-cooling prior to surgery in order to reduce blood flow (bleeding). A lower blood velocity implies a lower blood pressure and a lower blood pressure will cause less bleeding during surgery. As there are no rebound effects, pre- cooling can be optimized.
• the inventive apparatus can also be used postoperative immediately in recovery or during a recovery phase at home.
• the inventive mild cooling modulation scheme is well suited to achieve lymphatic drainage and it can be used for temperature modulation in pre- and post-operative muscular skeletal trauma.
• Several known systems use in combination with cryotherapy intermittent compression, to support lymphatic draining, and maintenance of circulation. Intermittent compression can cause concern in the acute phase of traumatic injury. Additionally the intermittent compression is compensating for the low colder temperatures used in these systems to support maintenance of the circulation (as air flow is decreased, oxygenated blood returns to the area), through this pumping mechanism.
• the inventive mild cooling modulation scheme is well suited to treat musculoskeletal trauma. It enables a pre-surgical reduction of swelling and pain and thus helps to decrease the time to surgery and it stabilizes the surgical field.
• the inventive mild cooling modulation scheme can be used in connection with orthopedic and or maxillofacial surgeries, since it reduces the swelling, the pain and a possible inflammation following surgical procedures. It thus helps to increase drug free patient comfort and patient mobility. [00106] Since it is able to reduce swelling and pain, the invention can be used in rehabilitation prior to, during or following a manual and functional physiotherapy (example, whilst patient is undergoing continuous passive or active motion therapy the inventive apparatus can be used), or for longer periods of rehabilitation recovery, and or pain management therapy.
• the invention can be used in connection with the treatment of chronic pain or in order to reduce acute pain.
• the apparatus is very well suited for use at home. Patients thus will be able to reduce their chronic pain.
• tissue healing from post mastectomy procedures, for instance.
• inventive apparatus can be used in the area of treating migraine headaches, and or sleeping disorders, in which the modulation schemes of both mild cooling and or mild healing have shown benefits.
• inventive apparatus as well is in the area of scalp cooling in which, this mild cooling modulation scheme supports reduction of hair loss in cancer patients receiving chemotherapy.
• inventive apparatus can be used in the area of cosmetic surgery (e.g. medical aesthetic treatments).
• the inventive apparatus can also be used in connection with non-surgical cosmetic procedures.
• the apparatus is well suited for use in cosmetic studios and in other facilities, where a non-invasive and/or non-medical treatment is carried out. Both mild cooling and or mild heating modulation schemes may be appropriate.
• the apparatus is well suited for use in connection with aesthetic treatments. If employed in a pre-operative facial procedure, the apparatus can help reduce the sensitivity to radio frequency and or laser treatments. [00114] The cooling can reduce the pain of injection techniques into the facial area, which can help to avoid the use of anesthetics, which are inherent to cascading effects.
• cooling has a tightening effect.
• Current treatments are ice, gel packs, cool alcohol treatments, which are very cold, and dry out the skin, and cause pain after Ultrasound applications as an example.
• a controlled cooling in accordance with the invention can have a positive effect on these results such that comfort is there and no rebound effects are experienced.
• the cold-heat modulation of the invention can be used in connection with skin treatment.
• the collagen in the skin may be tightened by modulation from cold to warm during a temperature cycle, as well as providing increased circulation to the skin. This can be done in a safe and practical manner using the modulation technique of the invention.
• the modulation from cold to warm can be used whilst persons uses facial creams that have high "lipid-fat” emollients to support hydration, dry skin, aging. These types of creams can be better absorbed into the skin by opening the skin pores, which can be done through continuous heating in a controlled way. Likewise, the use of facial cleaning masks, can as well penetrate better the pores, and attain better cleaning. In both instances, the modulations can occur whilst the creams, are on the face, thus increasing the performance of the activation of such creams or cleaners.
• the inventive modulation scheme provides a mechanism of action in which no active compression is required.
• the apparatus of preferred embodiments has the ability to precisely modulate the exposure to heat and cold in accordance with defined schemes, e.g. using an appropriate algorithm.
• the apparatus is also able to achieve steeper up and down slopes.
• the apparatus of the invention can be actively warmed up and then actively cooled back down, in a controlled and predefined manner. [00121] The apparatus of the invention gives less pain to patients since it does not expose the patient to ice directly
• the invention applies controlled cold for effective pain relief without the risk of peripheral nerve damage and other risks associated with colder temperatures like ice packs.
• the invention helps in preserving original tissue, which is beneficial for that rate of recovery.
• the inventive apparatus might be provided with pre-set temperature-time modulation schemes or such schemes might be loaded into the apparatus, as needed (e.g. using a computer or notepad or some other kind of human-machine interface).
• the apparatus gives a simple to use, robust platform for various treatments including medical and non-medical treatments.
• the respective temperature modulation scheme can be picked from a list of existing schemes, or it can be defined by interaction with the apparatus or with a human-machine interface connected to the apparatus.
• the apparatus of the invention may comprise at least one sensor that fits between the patient skin and the pad, or in the outflow from the pad.
• This sensor is connectable to the controller and the controller is implemented or programmed to execute a pre-defined modulation scheme when the sensor indicates that a specified temperature has been reached or when the controller via the sensor detects or recognizes a certain pre-defined temperature-time behavior or pattern.
• the controller is implemented or programmed to apply changes to a currently executed modulation scheme if the sensors indicates that a specified temperature has been reached.
• the apparatus preferably provides a well-defined outcome through standardized applications consisting of accurate temperature in the mild band and time ranges, ensuring safe and comfortable application of cold and heat.
• the apparatus of the invention in a preferred embodiment includes means for precooling and/or preheating so that a treatment can start at the right temperature.
• the inventive apparatus provides for occasional temperature fluctuations, which are integrated in or defined by pre-set protocols, herein called modulation schemes.
• the invention is based on the recognition that typically the skin is not the target tissue during cooling, but it is the tissue or other deeper structures that are most affected by it.
• the physiological stress on the skin is decreased. Because of the fact that there is delayed cooling in deeper tissues in case of a mild cooling approach, one can increase the application temperature without compromising deep tissue cooling.
• Thermal receptors are phasic receptors, which implies that they adapt to a stimulus rather quickly. As thermal receptors are linked with pain receptors it is therefore beneficial to regularly apply repeated cold stimuli integrated in the modulation scheme, as experiments have confirmed.
• heating influences hemodynamic, metabolic and neuromuscular processes. It also increases the extensibility of soft tissues. The heating might cause vasodilation in the tissue and it thus might increase the rate of blood flow. The increased blood flow in turn increases the delivery of oxygen and nutrients and the removal of waste products.
• the invention thus uses a modulation scheme comprising a combination of cooling and heating steps.
• heat or heating do not imply that excess heat is applied to the skin.
• the heating can also be a relative process where a previously cooled skin is caused to return to its previous temperature. Heating not necessarily refers to a heating beyond the normal skin temperature.
• the apparatus of the invention is well suited for the treatment of fibromyalgae, haematomas, tendinitis and trigger points (myofascial syndrome).
• the apparatus of the invention requires no mechanical pressure intervention, it requires no electrical stimulation of the body nor does it require sensors to make measurements of or at the body.
• the apparatus and its human-machine interface are designed so that the apparatus can be easily operated.
• the inventive apparatus can be used in a non-medical commercial environment and the inventive method can be carried out in a non-medical commercial environment, too.
• the method presented and claimed herein does involve only a minor intervention and it has no substantial health risks, when carried out with the required care.
• the apparatus of the invention actually reduces the risks, which so far have been associated with certain hot and cold treatments.
• the method of the invention is non-invasive and the complexity of the modulation operations are fully integrated into the apparatus, which, after it has been activated performs all steps automatically and without human intervention.
• Fig. 1 a schematic block diagram of a first embodiment of the invention
• Fig. 2 a schematic temperature-time diagram showing a curve PI being part of a first modulation scheme MSI of a first embodiment of the invention, a first curve Kl representing the general skin temperature, and a second curve K2 representing the skin temperature response while applying the modulation scheme MSI;
• Fig. 3 a schematic temperature-time diagram showing a second modulation scheme MS2 of the invention
• Fig. 4 a schematic temperature-time diagram showing a third modulation scheme MS3 of the invention
• Fig. 5 a schematic temperature-time diagram showing a fourth modulation scheme MS4 of the invention and a curve, which represents the actual tank temperature;
• FIG. 6 a schematic picture of a pad while being fixed to a leg
• Fig. 7 a schematic block diagram of another embodiment of the invention
• Fig. 8 a schematic blood flow velocity-time diagram showing the reaction of the blood flow during and after the application of another modulation scheme of the invention
• FIG. 9 another schematic blood flow velocity-time diagram showing the reaction of the blood flow during and after a treatment at a constant low temperature and during and after the application of another modulation scheme of the invention.
• fluid F refers to a process fluid, which is able to be circulated through the fluid lines/fluid system of the apparatus 100.
• Very well suited is water (preferably distilled water or deionized water) with or without admixtures (e.g. with Ethylene Glycol).
• the fluid lines are employed in order to feed the fluid F from a tank 101 into a bladder 401 of a pad 400 and from the bladder 401 back into the tank 400.
• a first line (called OUT) connects a combined cooling and heating system 200/500 to the input 112 of a bladder 401.
• This bladder 401 preferably has an internal channel structure to evenly distribute the fluid F.
• all embodiments of the invention comprise a cooling system 200 being designed as separate loop.
• the cooling system 200 has a chilling fluid (preferably a gas) which is caused to circulate through the separate loop 201.
• This loop 201 is in contact with the tank 101 and/or fluid F in order to draw heat from the fluid F. Details of one possible implementation are depicted in Fig . 7.
• all embodiments of the invention comprise a compressor 202 as part of the cooling system 200 (cf. Fig. 7).
• all embodiments of the invention comprise a cooling system 200, which is designed in order to provide a continuous supply of fluid F at a defined and controlled temperature and flow rate to an external pad 400.
• the cooling system 200 of all embodiments might comprise an air-cooled refrigeration system.
• the air- cooled refrigeration system might comprise a compressor 202, a heat exchanger (here an evaporator 201) in contact with the tank 101 and/or the fluid F, a condenser 203, a recirculating pump 102, a tank 101 serving as reservoir, and a microprocessor controller 300 (e.g. a separate computer or an integrated controller).
• the interaction of the controller 300 is schematically shown by means of three dashed arrows connecting the controller 300 with a heating system 500, pump 102 and cooling system 200.
• the compressor 202, heat exchanger (here an evaporator 201) and the condenser 203 are part of a closed loop in which a gas is caused to circulate.
• the condenser 203 removes heat energy and discharges it into the atmosphere (on air-cooled units) or facility water (water-cooled units). This process causes a change of state from a gas to a liquid (the gas condenses).
• the liquefied gas is a high-pressure liquid, which is introduced into a low pressure area of the evaporator 201 where it changes state from a liquid to a gas (the liquid evaporates). This change of state requires energy.
• the energy is gained from (removed from) the fluid F or from the tank 101. This leads to a cooling of the fluid F.
• the apparatus 100 comprises an active heating system 500.
• all embodiments of the invention comprise a heating system 500, which has a heater capacity in the range between 1 kW and 5 kW.
• all embodiments of the invention comprise a cooling system 200, which has a cooling capacity in the range between 100W and 1 kW.
• All embodiments of the invention might comprise a powerful Peltier element as combined heating and cooling system 200/500.
• the head-load of the apparatus 100 on the cooling system 200 is typically between lkW and 5kW, depending on the size of the pad 400, respectively the fluid volume of the bladder 401. This means that the cooling system 200 has to have sufficient power in order to remove between lkW and 5kW in heat from the fluid F.
• Fig. 5 shows a dotted curve of one possible mild cooling modulation scheme MS4 of the invention.
• the solid curve shows the actual tank temperature. There is almost no deviation between the two curves of Fig. 5, which confirms that the apparatus 100 has enough heating and cooling power to closely follow the curve of a modulation scheme.
• the apparatus 100 comprises an active cooling system 200 and an active heating system 500.
• all embodiments of the invention comprise a heating coil 501 (e.g. an electrically heated heating coil 501) which is part of the heating system 500, as schematically illustrated in Fig. 7.
• the heating coil 501 can be wound around a fluid line on the output side of the tank 101.
• This line which is designated with the word OUT, can be put in fluidic connection with an input 112 of the pad 400 (cf. Fig. 1).
• a feedback line, designated with the word IN can be put in fluidic connection with an output 113 of the pad 400 (cf. Fig. 1).
• All embodiments of the invention may also comprise a heating coil (e.g. an electrically heated heating coil) which sits inside the fluid F in the tank 101 or which is in thermal connection with the wall of the tank 101.
• a heating coil e.g. an electrically heated heating coil
• the controller 300 of all embodiments is implemented or programmed to execute a modulation scheme (e.g. the first modulation scheme MSI of Fig. 2) having a pyramid shaped temperature-time curve PI.
• This pyramid shaped temperature-time curve PI has a first downward slope DS1 during which the temperature of a pad 400 is cooled from a first temperature Tl to a second temperature T2, a first period HS1 during which the pad 400 is essentially kept at the second temperature T2, and a first upward slope USl during which the temperature of the pad 400 is heated or warming up to a third temperature T3.
• a modulation scheme e.g. the first modulation scheme MSI of Fig. 2
• This pyramid shaped temperature-time curve PI has a first downward slope DS1 during which the temperature of a pad 400 is cooled from a first temperature Tl to a second temperature T2, a first period HS1 during which the pad 400 is essentially kept at the second temperature T2, and a first upward slope USl during which the temperature of the pad
• Fig. 2 shows a schematic temperature-time diagram of the curve PI .
• the curve PI has the shape of a thermo pyramid.
• a first curve Kl is depicted in the diagram of Fig. 1, which represents the general skin temperature of the human body while wearing a pad 400 wrapped around a knee.
• the second curve K2 represents the skin temperature response while applying the modulation scheme MSI.
• the curve K2 follows the temperature- time curve PI with a small time delay.
• the controller 300 of all embodiments is implemented or programmed to execute a modulation scheme (e.g. the second modulation scheme MS2 of Fig. 3) having a temperature-time curve with two pyramid shaped curves PI and P2.
• a modulation scheme e.g. the second modulation scheme MS2 of Fig. 3
• the temperature-time curve of the second modulation scheme MS2 has a first downward slope DS1 during which the temperature of a pad 400 is cooled from a first temperature Tl to a second temperature T2, a first period HS1 during which the pad 400 is essentially kept at the second temperature T2, a first upward slope US1 during which the temperature of the pad 400 is heated or warming up to a third temperature T3, a second downward slope DS2 during which the temperature of a pad 400 is cooled from third temperature T3 to a fourth temperature T4.
• the controller 300 of all embodiments is implemented or programmed to execute a mild cooling modulation scheme (e.g. the third modulation scheme MS3 of Fig. 4) having a temperature-time curve with four pyramid shaped curves PI - P4.
• the temperature-time curve of the third modulation scheme MS3 comprises:
• the temperature-time curve of the fourth mild cooling modulation scheme MS4 (cf. Fig. 5) comprises :
• modulation schemes of the invention can be created based on any of the examples MSI - MS5.
• a modulation scheme can also be created by picking individual elements of the curves of the examples MSI - MS5 and by combining them into one consecutive curve.
• Fig. 6 shows the example of a pad 400 which is designed for being wrapped around the lower leg of a human body.
• the pad 400 here has an insulating backing 402 (e.g. a PU backing) with three VelcroTM straps 411.
• insulating backing 402 e.g. a PU backing
• bladder 401 inside the pad 400, which is in fluid connection with the fluid lines 111.
• Fig. 7 shows details of another preferred embodiment of a portion of an apparatus 100.
• the apparatus 100 comprises an active cooling system 200 which here is implemented by means of a closed-loop, gas-filled compressor system. Details of such a cooling system 200 have been described before and are thus not repeated here.
• the apparatus 100 further comprises an active heating system 500, which here is implemented by means of a heating coil 501, which is wound around a pipe of the fluid system 111.
• the heating coil 501 is placed at the output side of the tank 101 between the tank 101 and the pad 400 (not shown).
• the active cooling system 200 and the active heating system 500 together are able to influence the temperature of the fluid F of the fluid system 111.
• the term fluid system 111 refers to the fluid lines connecting the tank 101 with the pad 400 (cf. Fig. 1).
• the apparatus 100 further comprises an external or internal controller 300 for operating the cooling system 200 and the heating system 500.
• the control function of the controller 300 is depicted by dashed arrows, which put the controller 300 in connection with the cooling system 200, the heating system 500, and the pump 102.
• the pump 102 is mounted on top of the tank 101 and it has an aspiration nozzle 103, which protrudes into the fluid F.
• the pump 102 is designed and driven (e.g. via an optional driver 350) so as to suck in fluid F through the nozzle 103 and to pump it through the OUT line into the bladder 401.
• the fluid F flows back through the output 113 of the bladder 401 and the IN line into the pump 102 or right into the tank 101.
• the apparatus 100 has a special function, which enables a patient to intervene, e.g. by pressing a button 302, as illustrated in Fig. 7.
• the respective special function is preferably implemented so that by a human intervention, the modulation scheme is temporarily adapted.
• This adaptation of the modulation scheme could for instance cause a small increase of the temperature of the fluid F running through the bladder 401 of the pad 400.
• the increase of the temperature is predefined to be in a range between 1 and 5°C.
• the apparatus might comprise a button 302, as illustrated in Fig. 7, or some other machine-human interface (e.g. a touch screen) could be used for this purpose. All embodiments of the invention might comprise means enabling the user or operator to cause a (temporary) adaptation.
• the apparatus 100 of the invention comprises at least one sensor 413 (see Fig. 7) that fits between the patient skin and the pad 400.
• This sensor 413 is connectable to the controller 300 and the controller 300 is implemented or programmed to execute a predefined modulation scheme when the sensor 413 indicates that a specified temperature has been reached or when the controller 300 via the sensor 413 detects or recognizes a certain pre-defined temperature-time behavior or pattern.
• the controller 300 is implemented or programmed to apply changes to a currently executed modulation scheme if the sensors 413 indicates that a specified temperature has been reached.
• Fig. 8 shows a schematic blood flow velocity-time diagram. This diagram shows the reaction of the blood flow velocity v in the Arteria poplitea during and after the application of another modulation scheme of the invention.
• the blood flow velocity v is in the range below 60 cm/s and above 40 cm/s.
• the modulation period (t > S3) the blood flow velocity v clearly remains below 60 cm/s.
• Fig. 9 shows another schematic blood flow velocity-time diagram.
• This diagram shows the reaction of the blood flow velocity v in the Arteria poplitea prior, during and after a temperature treatment with a conventional system, which is applying a constant 3°C temperature to a part of a human body (dashed curve in Fig. 9).
• the temperature treatment begins at SI and ends at S2.
• the blood flow velocity v starts to ramp down and up during the treatment with a constant temperature.
• the variations shown in Fig. 9 (dashed curve in Fig. 9) are a normal reaction of the body that tries to deal with the constant cold temperature. Simply put, the cold temperature causes stress in the body and the body reacts accordingly by inducing vasodilation (called Hunting reaction.
• the solid curve is the blood flow velocity v prior, during and after a treatment with an inventive modulation scheme (MS5).
• the solid curve shows some form of modulation, which follows the modulation scheme MS5 applied. Please note that after the treatment with the modulation scheme MS5 (t > S3), the blood flow velocity v (solid curve) raises slowly. It remains below the initial 60 cm/s.
• the dotted curve shows the temperature-time diagram of the modulation scheme MS5 used in this context.
• Insulated backing 402 means for connecting the pad to the 410

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• 2014
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