I*I
`
`Innovation, Sciences et
`Développement économique Canada
`Office de la Propriete lntellectuelle du Canada
`
`Innovation, Science and
`Economic Development Canada
`Canadian Intellectual Property Office
`
`CA 3019140 A1 2017/10/12
`(21) 3 019 140
`
`(12) DEMANDE DE BREVET CANADIEN
`CANADIAN PATENT APPLICATION
`
`(13) A1
`
`(86) Date de dépot PCT/PCT Filing Date: 2017/04/03
`
`(51) CI.|nt./Int.C|_ A61F 7/00(2006.01)
`
`(87) Date publication PCT/PCT Publication Date: 2017/10/12
`
`(85) Entrée phase nationale/National Entry: 2018/09/26
`
`(86) N° demande PCT/PCT Application No_: US 2017/025705
`
`(87) N° publication PCT/PCT Publication No_: 2017/176621
`
`(30) PrioritéS/Priorities: 2016/04/04 (U862/317,953);
`2017/02/02 (U862/453,670)
`
`(71) Demandeur/Applicant:
`AIR PRODUCTS AND CHEMICALS, |NC., US
`
`(72) Inventeurs/Inventors:
`TREMBLEY, JEAN-PHILIPPE, US;
`VIROUX, PATRICK, US;
`TIEMESSEN, lVO JOHANNES HENDRIKUS, US
`
`(74) Agent: GOWLING WLG (CANADA) LLP
`
`
`
`
`(54) Titre : APPAREIL DE CRYOTHERAPIE A REFROIDISSEMENT INDIRECT
`(54) Title:
`INDIRECTLY COOLED CRYOTHERAPY APPARATUS
`
`FIG- 1
`
`(57) Abrégé/Abstract:
`A cryotherapy apparatus including a heat exchanger, a cryotherapy chamber, cryogenic nitrogen supply and exhaust conduits to
`and from the heat exchanger, an air return conduit to flow warmed airfrom the cryotherapy chamber to the heat exchanger, an air
`supply conduit to flow chilled air from the heat exchanger to the cryotherapy chamber, a variable speed fan to cause flow of air
`through a loop including the air supply and return conduits, the heat exchanger, and the cryotherapy chamber, and a controller
`programmed to control the flow rate of air by regulating the speed of the variable speed fan according to a treatment protocol; and
`a method of delivering cryotherapy according to a customized treatment protocol taking into account one or more of: a patient's
`treatment goals, a customization factor, a personalization factor, and an adaptation factor.
`
`
`50 rue Victoria
`50 Victoria Street
`
`0 Place du Portage 1
`0 Place du Portage 1
`
`0 Gatineau, (Quebec) KlA 0C9 0 www.0pic.ic.gc.ca
`0 Gatineau, Quebec
`KlA 0C9 0 www.cip0.ic.gc.ca
`
`I‘I'I
`al I a a
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`

`

`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(19) World Intellectual Property
`Organization
`International Bureau
`
`CA 03019140 2018-09-26
`
`\9
`
`WIPOI PCT
`
`(81)
`
`(43) International Publication Date
`12 October 2017 (12.10.2017)
`
`(51)
`
`International Patent Classification:
`A61F 7/00 (2006.01)
`
`(21)
`
`International Application Number:
`
`PCT/US201 7/025705
`
`(22)
`
`International Filing Date:
`
`(25)
`
`(26)
`
`(30)
`
`(71)
`
`(72)
`
`Filing Language:
`
`Publication Language:
`
`3 April 2017 (03.04.2017)
`
`English
`
`English
`
`Priority Data:
`62/317,953
`62/453,670
`
`4 April 2016 (04.04.2016)
`2 Febmary 2017 (02.02.2017)
`
`US
`US
`
`Applicant: AIR PRODUCTS AND CHEMICALS. INC.
`[US/US]; 7201 Hamilton Boulevard, Allentown, PA 18195
`(US).
`
`Inventors: TREMBLEY, Jean-Philippe; 7201 Hamilton
`Boulevard, Allentown, PA 18195
`(US). VIROUX,
`Patrick; 7201 Hamilton Boulevard, Allentown, PA 18195
`(US). TIEMESSEN,
`Ivo, Johannes, Hendrikus; 7201
`Hamilton Boulevard, Allentown, PA 18195 (US).
`
`(10) International Publication Number
`
`WO 2017/176621 A1
`
`Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY,
`BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM,
`DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN,
`KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA,
`MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG,
`NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS,
`RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY,
`TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN,
`ZA, ZM, ZW.
`
`(84)
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ,
`TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU,
`TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE,
`DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
`LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
`SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, KM, ML, MR, NE, SN, TD, TG).
`Declarations under Rule 4.17:
`
`
`
`W02017/176621A1|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`(74)
`
`Agent: NEAGLE, Damon, A.; Design IP, PC, 5050 W.
`Tilghman Street, Suite 435, Allentown, Pennsylvania
`18104 (US).
`
`ofinventorship (Rule 4.17(iv))
`Published:
`
`with international search report (Art. 21(3))
`
`(54) Title: INDIRECTLY COOLED CRYOTHERAPY APPARATUS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FIG. 1
`
`(57) Abstract: A cryotherapy apparatus including a heat exchanger, a cryotherapy chamber, cryogenic nitrogen supply and exhaust
`conduits to and from the heat exchanger, an air return conduit to flow warmed air from the cryotherapy chamber to the heat ex—
`changer, an air supply conduit to flow chilled air from the heat exchanger to the cryotherapy chamber, a variable speed fan to cause
`flow of air through a loop including the air supply and return conduits, the heat exchanger, and the cryotherapy chamber, and a con —
`troller programmed to control the flow rate of air by regulating the speed of the variable speed fan according to a treatment protocol;
`and a method of delivering cryotherapy according to a customized treatment protocol taking into account one or more of: a patient's
`treatment goals, a customization factor, a personalization factor, and an adaptation factor.
`
`

`

`WO 2017/176621
`
`PCT/USZOl7/025705
`
`CA 03019140 2018-09-26
`
`INDIRECTLY COOLED CRYOTHERAPY APPARATUS
`
`TITLE
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001] This application claims the priority of US. Provisional Application No. 62/317,953, filed
`
`on April 4, 2016, and U.S. Provisional Application No. 62/453,670, filed on February 2, 2017,
`
`each ofwhich is incorporated by reference herein in its entirety.
`
`BACKGROUND
`
`[0002] An apparatus and methods are described herein for providing customized cryotherapy
`
`treatments using an indirectly cooled single-occupancy cryotherapy device or multi-person
`
`1O
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`cryotherapy chamber.
`
`15
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`20
`
`25
`
`[0003] Whole-body cryostimulation/cryotherapy (WBC) is a non-invasive technique
`
`characterized by relatively short bursts of cold (-90°C to -140°C) for about 2 — 4 minutes to the
`
`body periphery (i.e., exposed skin surface area) that provoke and harness reactions to cold,
`
`causing various physiological reactions that may promote healing and recovery.
`
`[0004] Existing single-person cryotherapy devices, or cryosaunas, include a chamber where a
`
`patient stands inside with the patient’s head protruding above the top of the cryosauna.
`
`ln
`
`previously-existing devices, cooling is typically provided directly by liquid nitrogen (LIN) (or
`
`occasionally by liquid air, if available), wherein the vaporized LIN, which is now very cold
`
`nitrogen gas (GAN), comes into direct contact with the patient. First, the LIN flows into a LIN
`
`reservoir mounted behind or beneath the chamber, where it is vaporized immediately, and then
`
`the very cold GAN is flowed into the chamber.
`
`[0005] Typically, the GAN flow is driven by the gas expansion caused by the vaporization.
`
`However, in some cases, a blower or fan is used to circulate the GAN. The very cold GAN thus
`
`provides the cooling for the patient. The temperature is controlled to prevent the vaporized
`
`nitrogen from getting too cold for the patient, and protection is also provided to prevent LIN
`
`carryover into the chamber, although the possibility for entrained droplets of LIN does exist.
`
`[0006] Each patient can usually adjust his or her position inside of the chamber to ensure that
`
`the head is above the cold nitrogen atmosphere. This is typically accomplished by a height
`
`adjustable side wall, a movable standing platform, or something simple like a box.
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`WO 2017/176621
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`[0007] These existing cryosaunas are very similar across all suppliers, and all suffer from
`
`similar performance difficulties. The primary difficulty is that the temperature within the
`
`chamber is often considerably different from top to bottom of the chamber, sometimes by as
`
`much as 70° C when controlling to a set point of -135°C (e.g., -150°C at the bottom and —80°C
`
`at the top). This temperature gradient is does not provide for consistent and well-controlled
`
`cryotherapy treatments; a more homogeneous exposure temperature (evenness of cold) is
`
`preferred. A secondary difficulty is the possible safety (i.e., asphyxiation) hazards of exposure
`
`of a patient to high concentrations of nitrogen, as well as the potential cold burns caused by
`
`entrained LIN droplet contact with a patient.
`
`[0008]
`
`In addition, implementing cryotherapy stimulation preferably requires adequate
`
`protocol settings, in particular related to safety, due to the extreme cold conditions to which the
`
`individuals are exposed, but also to produce beneficial therapeutic results.
`
`It is known that
`
`there is considerable between-subject variability in skin cooling responses to WBC, and as
`
`patients and athletes feature a wide variety of anthropometric and morphological body
`
`characteristics, a one-size-fits-all strategy appears to be inadequate regarding the safety and
`
`efficacy of the treatment. See Hammond, L.E., Cuttell, S., Nunley, P., Meyler, J.,
`
`Anthropometric characteristics and sex influence magnitude of skin cooling following exposure
`
`to whole body cryotherapy, Biomed. Res. Int. 2014, 628724, which is incorporated herein by
`
`reference in its entirety. The skin temperature response of individuals with a higher adiposity is
`
`faster and more pronounced compared to thinner individuals thereby affecting their safety and
`
`the treatment efficacy.
`
`[0009] As described herein, the well-validated Fiala thermal Physiology and Comfort
`
`numerical simulation model has been utilized for cryotherapy applications to assess the impact
`
`of personal characteristics on the skin cooling responses and stimulation settings in relation to
`
`safety and efficacy. See Fiala, D., Lomas, K. J., Stohrer, M, 1999, A computer model ofhuman
`
`thermoregulation for a wide range of environmental conditions: the passive system, J. Appl.
`
`Physiol. 87, 1957—1972; and Fiala, D., Havenith, G., 2016, Modelling human heat transfer and
`
`temperature regulation, In: Gefen, A., Epstein, Y. The Mechanobiology and Mechanophysiology
`
`of Military-Related Injuries. Springer International Publishing, Cham: 265-302, which are each
`
`incorporated herein by reference in their entirety.
`
`SUMMARY
`
`[0010] Aspect 1. A cryotherapy apparatus comprising: a heat exchanger mounted in an
`
`exchanger enclosure; a cryotherapy chamber configured to receive at least a portion of a body
`
`of a patient designated to receive cryotherapy; a nitrogen supply conduit configured to supply
`
`10
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`15
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`20
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`25
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`30
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`CA 03019140 2018-09-26
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`cryogenic nitrogen to the heat exchanger; a nitrogen exhaust conduit configured to exhaust
`
`nitrogen from the heat exchanger; an air return conduit configured to flow warmed return air
`
`from the cryotherapy chamber to the heat exchanger enclosure; an air supply conduit
`
`configured to flow chilled air from the heat exchanger enclosure to the cryotherapy chamber; a
`
`variable speed fan configured to cause a flow rate of chilled air through a loop including the air
`
`return conduit, the heat exchanger, the air supply conduit, and the cryotherapy chamber; and a
`
`controller programmed to control the flow rate of chilled air to the cryotherapy chamber by
`
`regulating the speed ofthe variable speed fan according to a treatment protocol.
`
`[001 1] Aspect 2. The cryotherapy apparatus of Aspect 1, wherein the fan is a reversible fan
`
`configured to enable a flow rate of chilled air through the loop in either direction.
`
`[0012] Aspect 3. The cryotherapy apparatus of Aspect 1 or Aspect 2, further comprising a
`
`control valve in the nitrogen supply conduit to regulate the supply of cryogenic nitrogen,
`
`wherein the controller is further programmed to control the supply of cryogenic nitrogen
`
`according to a treatment protocol.
`
`[0013] Aspect 4. The cryotherapy apparatus of any one ofthe preceding Aspects, wherein the
`
`controller is further programmed to selectively direct the chilled air to one or more selected
`
`portions of the body of a patient designated to receive cryotherapy, and to control the flow rate
`
`of the chilled air to the one or more selection portions of the human body.
`
`[0014] Aspect 5. The cryotherapy apparatus of any one ofthe preceding Aspects, further
`
`comprising a temperature sensor positioned to sense a return airtemperature, wherein the
`
`controller is further programmed to control the flow rate of air based at least on part on the
`
`return air temperature.
`
`[0015] Aspect 6. The cryotherapy apparatus of any one ofthe preceding Aspects, further
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`comprising a condensate drain positioned at a low point in the air return conduit for removing
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`condensation formed in one or both of the exchanger enclosure and the cryotherapy chamber.
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`[0016] Aspect 7. The cryotherapy apparatus of any of the preceding Aspects, further
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`comprising a temperature sensor to sense a nitrogen exhaust temperature, wherein the
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`controller is further programmed to shut off liquid nitrogen supply if the nitrogen outlet
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`temperature is at or below a preset limit.
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`[0017] Aspect 8. The cryotherapy apparatus of any of the preceding Aspects, further
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`comprising a heater in the air return conduit for heating the recirculating airto enable defrosting
`
`of the cryotherapy chamber.
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`10
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`15
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`[0018] Aspect 9. The cryotherapy apparatus of any of the preceding Aspects, wherein the
`
`controller is further programmed to provide customized treatment protocols based one or more
`
`of: a characteristic of the patient being treated, a type of treatment required, a type of injury
`
`being treated, a type of athletic activity from which recovery is desired, and a portion of the
`
`body requiring treatment.
`
`[0019] Aspect 10. The cryotherapy apparatus of Aspect 9, wherein the controller is
`
`programmed to provide customized treatment protocols taking into account a patient’s
`
`treatment goals.
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`[0020] Aspect 11. The cryotherapy apparatus of Aspect 9 or Aspect 10, wherein the controller
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`is programmed to provide customized treatment protocols taking into account a customization
`
`factor based one or more of a patient’s susceptibility to cold, age, and athletic type.
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`[0021] Aspect 12. The cryotherapy apparatus of any one of Aspects 9 to 11, wherein the
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`controller is programmed to provide customized treatment protocols taking into account a
`
`personalization factor based on one or more of a patient’s body height, mass, surface area,
`
`body surface area-to-mass ratio, body fat percentage, lean body mass, body mass index, and
`fat free mass index.
`
`[0022] Aspect 13. The cryotherapy apparatus of any one of Aspects 9 to 12, wherein the
`
`controller is programmed to provide customized treatment protocols taking into account a and
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`an adaptation factor based on one or both of treatment frequency and a treatment cycle.
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`[0023] Aspect 14. The cryotherapy apparatus of Aspect 9, wherein the customized treatment
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`protocols enable customization of a portion of the body being treated, exposure times, timed
`
`cycles, exposure temperatures, temperature cycles, cold intensity, and cold intensity cycles.
`
`[0024] Aspect 15. The cryotherapy apparatus of Aspect 9, wherein the controller is
`
`programmed to provide customized treatment protocols taking into account one or more of: a
`
`patient’s treatment goals, a customization factor, a personalization factor, and an adaptation
`
`factor; wherein the customization factortakes into account one or more of a patent’s cold
`
`susceptibility, a patient’s age, and a patient’s athletic type; wherein the personalization factor
`
`takes into account one or more of a patient’s body height, mass, surface area, body surface
`
`area-to-mass ratio, body fat percentage, lean body mass, body mass index, and fat free mass
`
`index; and wherein the adaptation factor takes into account a one or both of treatment
`
`frequency and a treatment cycle.
`
`[0025] Aspect 16. The cryotherapy apparatus of any one of Aspects 9 to 15, wherein the
`
`controller is programmed to provide customized treatment protocols by calculating one or more
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`CA 03019140 2018-09-26
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`of the patient’s treatment goals, the customization factor, the personalization factor, and the
`
`adaptation factor based on a reference athlete.
`
`[0026] Aspect 17. The cryotherapy apparatus of any of the preceding Aspects, wherein the
`
`chilled air flow rate is controlled to provide a treatment temperature from -150 °C to
`-90 °C.
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`[0027] Aspect 18. The cryotherapy apparatus of any of the preceding Aspects, wherein the
`
`chilled air flow rate is controlled to provide a treatment temperature from -135 °C to
`-110 °C.
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`1O
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`15
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`20
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`25
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`30
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`[0028] Aspect 19. The cryotherapy apparatus of any of the preceding Aspects, wherein the
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`chilled air flow is controlled to provide a heat transfer effect from 5 W/m2 °C to 100 W/m2 °C.
`
`[0029] Aspect 20. A method of delivering cryotherapy using a cryotherapy chamber
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`configured to receive at least a portion of a human body designated to receive cryotherapy, the
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`method comprising: recirculating air in a loop through a heat exchanger, into the cryotherapy
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`chamber, and out form the cryotherapy chamber, and returning to the heat exchanger; chilling
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`the air to a therapeutic chilled air temperature in the heat exchanger by heat exchange with
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`liquid nitrogen; and operating the cryotherapy chamber according to a customized treatment
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`protocol comprising controlling the flow rate of the chilled air.
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`[0030] Aspect 21. The method of Aspect 20, operating the cryotherapy chamber according to
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`a customized treatment protocol further comprising: selectively directing the chilled airto one or
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`more selected portions of the body of a patient designated to receive cryotherapy; and
`
`controlling the flow rate of the chilled airto the one or more selection portions of the human
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`body.
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`[0031] Aspect 22. The method of Aspect 20 or Aspect 21, further comprising: controlling the
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`flow rate of the chilled air based on one or more of: a characteristic of the patient being treated,
`
`a type of treatment required, a type of injury being treated, a type of athletic activity from which
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`recovery is desired, and a portion ofthe body requiring treatment.
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`[0032] Aspect 23. The method of Aspect 22, further comprising: selectively directing the
`
`chilled air to the one or more selected portions of the body designated to receive cryotherapy
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`based on one or more of: a characteristic of the patient being treated, a type of treatment
`
`required, a type of injury being treated, a type of athletic activity from which recovery is desired,
`
`and a portion ofthe body requiring treatment.
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`

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`WO 2017/176621
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`PCT/USZOl7/025705
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`CA 03019140 2018-09-26
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`[0033] Aspect 24. The method of Aspect 23, further comprising customizing the treatment
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`protocol to vary one or more of: a portion of the body being treated, exposure times, timed
`
`cycles, exposure temperatures, temperature cycles, cold intensity, and cold intensity cycles.
`
`[0034] Aspect 25. The method of any one of Aspects 20 to 24, further comprising customizing
`
`the treatment protocol to take into account a patient's treatment goals.
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`[0035] Aspect 26. The method of any one of Aspects 20 to 25, further comprising customizing
`
`the treatment protocol to take into account a customization factor based one or more of a
`
`patient’s susceptibility to cold, age, and athletic type.
`
`[0036] Aspect 27. The method of any one of Aspects 20 to 26, further comprising customizing
`
`the treatment protocol to take into account a personalization factor based on one or more of a
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`patient’s body height, mass, surface area, body surface area-to-mass ratio, body fat
`
`percentage, lean body mass, body mass index, and fat free mass index.
`
`[0037] Aspect 28. The method of any one of Aspects 20 to 27, further comprising customizing
`
`the treatment protocol to take into account a and an adaptation factor based on one or both of
`
`treatment frequency and a treatment cycle.
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`[0038] Aspect 29. The method of any one of Aspects 20 to 24, further comprising: taking into
`
`account one or more of: a patient’s treatment goals, a customization factor, a personalization
`
`factor, and an adaptation factor; wherein the customization factortakes into account one or
`
`more of a patent’s cold susceptibility, a patient’s age, and a patient’s athletic type; wherein the
`
`personalization factor takes into account one or more of a patient’s body height, mass, surface
`
`area, body surface area—to-mass ratio, body fat percentage, lean body mass, body mass index,
`
`and fat free mass index; and wherein the adaptation factor takes into account a one or both of
`
`treatment frequency and a treatment cycle.
`
`[0039] Aspect 30. The method of any one of Aspects 22 to 29, further comprising calculating
`
`one or more of the patient’s treatment goals, the customization factor, the personalization
`
`factor, and the adaptation factor based on a reference athlete.
`
`[0040] Aspect 31. The method of any one of Aspects 20 to 30, further comprising: controlling
`
`the flow rate of the chilled air based at least in part on the temperature ofthe air returning to the
`
`heat exchanger.
`
`[0041] Aspect 32. The method of any one of Aspects 20 to 31, further comprising: draining
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`condensate from the loop.
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`[0042] Aspect 33. The method of any one of Aspects 20 to 32, further comprising: controlling
`
`the chilled air flow rate to provide a chilled airtemperature from -150 °C to -90 °C.
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`[0043] Aspect 34. The method of Aspect 33, further comprising: controlling the chilled air flow
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`rate to provide a chilled airtemperature from -135 °C to -110 °C.
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`[0044] Aspect 35. The method of any one of Aspects 20 to 34, further comprising: controlling
`
`the chilled air flow to provide a heat transfer effect from 5 W/m2 °C to 100 W/m2 °C.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0045] The present invention will hereinafter be described in conjunction with the appended
`
`figures wherein like numerals denote like elements:
`
`[0046]
`
`Fig.
`
`1
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`is a schematic showing an embodiment of an indirectly cooled cryotherapy
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`1O
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`apparatus.
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`[0047]
`
`Fig. 2 is a schematic showing a passive system model for thermal stimulation.
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`[0048]
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`Fig. 3 is a graphical depiction of predicted mean skin temperatures (Sim) for males
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`and females with averaged characteristics compared to means and SD of pre- and post-
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`exposure values (Exp) measured by Hammond.
`
`[0049]
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`Fig. 4 is a graphical depiction of body core, mean skin and lower leg skin temperatures
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`recorded from six volunteers (81-86) before (15 — 0 min), during (0 — 4 min), and after (4 — 60
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`min) exposure to WBC at -120 °C.
`
`[0050]
`
`Fig. 5 is a graphical depiction of the correlation between body fat content and the
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`minimum values of mean skin and lower leg skin temperature for both sexes from FPC
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`simulations of 3 min WBC exposure to -110 °C.
`
`[0051]
`
`Fig. 6 is a flow chart depicting an exemplary method of delivery customized cryotherapy.
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`DETAILED DESCRIPTION
`
`[0052] Described herein is an indirectly cooled single-occupancy cryotherapy device or
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`cryotherapy chamber where chilled air is re-circulated through a therapy chamber and re-
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`cooled by a cryogen heat exchanger to provide a more even temperature distribution within the
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`chamber from top to bottom.
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`In addition, the chilled air flow is controlled so that the amount of
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`cooling (cold intensity) can be adjusted to suit specific patient requirements, including but not
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`limited to the individual physical characteristics of the patient, and an integrated controller
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`enables customized treatment protocols to be applied. For example, treatment protocols can
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`be customized depending on the type of condition being treated (e.g., fatigue, sleep, recovery,
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`injury), and can be modified based on the characteristics of the patient (e.g., gender, size,
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`height, weight, skin type). The cold treatment provided can also be adjusted by controlling the
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`speed of the air flow through the chamber at one or more locations to vary the heat transfer
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`effect onto the skin and/or across various parts of the patient’s body.
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`[0053]
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`In one embodiment of an indirectly cooled single-occupancy cryotherapy device, the
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`re-circulating air flow can be adjusted to provide a desired height cooling curtain over the
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`patient within the therapy chamber, including an optional automatic adjustment to suit the
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`patient’s height. By using the adjustable-height cooling curtain, the type of cryotherapy
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`treatment can be customized, for example to target only the lower body, only the upper body,
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`another partial portion of the body, or even the entire body (i.e., whole body cryotherapy (WBC)
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`or partial body cryotherapy (PBC)).
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`[0054] Cooling is provided by liquid nitrogen (LIN), but the nitrogen can never come into
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`contact with the patient and is vented safely to atmosphere. The LIN is used to cool air by way
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`of a LIN-air heat exchanger, and the chilled air is recirculated through the therapy chamber and
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`re-cooled in a loop. A specially-designed heat exchanger allows for any moisture to be
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`collected in the cold surfaces of the exchanger without reducing the cooling performance ofthe
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`exchanger during its normal operating cycle.
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`[0055]
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`In a further embodiment, a heater may be installed in the recirculation air flow to clean
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`and defrost the therapy chamber after use, allowing waterto be drained safely from the
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`chamber and not leaving any reside in the patient area. This cleaning and defrosting ability
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`helps to ensure consistent performance of the apparatus.
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`[0056] An embodiment of an indirectly-cooled cryotherapy apparatus 10 is shown in Fig. 1.
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`The apparatus 10 includes an exchanger enclosure 20 configured to use liquid nitrogen to chill
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`recirculating air and a therapy chamber 50 configured to receive a patient’s body 90 designated
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`to receive cryotherapy. The exchanger enclosure 20 and the therapy chamber 50 may be
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`contained in a single physical structure, or may be two separate structures connected by the air
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`supply conduit 36 and the air return conduit 40.
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`[0057] During operation of the apparatus 10, air is recirculated in a nearly closed loop through
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`the exchanger enclosure 20 where it is chilled by heat exchange with vaporizing liquid nitrogen
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`and through the therapy chamber 50 where it is warmed by contact with a patient’s body. As
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`discussed further below, the air may be recirculated in either direction, depending on the
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`application.
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`[0058] The exchanger enclosure 20 houses a heat exchanger 24. A liquid nitrogen source 12
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`supplies liquid nitrogen to the heat exchanger 24 via a nitrogen supply conduit 22. Gaseous
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`nitrogen (which was vaporized during the heat exchange process) is exhausted to vent from the
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`heat exchanger 24 via a nitrogen exhaust conduit 26.
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`In the depicted embodiment, a variable
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`speed fan 32 is positioned in the exchange enclosure 20 below the heat exchanger 24 to
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`provide an upward flow of recirculating air across the heat exchanger 24. The fan 32 may be
`reversible to allow for recirculation of air in either direction. Recirculated air enters a lower
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`portion of the enclosure 20 below the fan 32 through an air return conduit 40, flows upward
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`through the fan 32 and then through the heat exchanger 24, and exits an upper portion ofthe
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`enclosure 20 above the heat exchanger 24 through an air supply conduit 36. The fan 32 can
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`be alternatively positioned above the exchange enclosure 20 to provide further flexibility and
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`flow control ofthe recirculating air.
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`[0059] The air supplied in the air supply conduit 36, which is the therapeutic chilled air, has
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`been chilled by the heat exchanger 24 to be coolerthan the air recirculated by the air return
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`conduit 40. The temperature of the therapeutic chilled air supplied to the therapy chamber 50
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`via the air supply conduit 36 is preferably as cold as or colder than
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`-90 °C and is more preferably as cold or colder than -110 °C and as cold as -135 °C for optimal
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`cryotherapy treatment effects. Typically, the chilled air is not colder than -150 °C. Alternatively
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`or in addition to controlling the therapeutic chilled airtemperature, the cold intensity may be
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`controlled. Cold intensity is defined as the net heat transfer effect of the treatment on a
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`patient’s body, and takes into account both the chilled air temperature and the air velocity
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`flowing through the chamber and/or across the patient’s body (which correlates to the heat
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`transfer coefficient). Preferably, the cold intensity is at least 5 W/m2 °C and no greater than 100
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`W/m2 °C, and more preferably the cold intensity is from 10 W/m2 °C to 50 W/m2 °C.
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`[0060] The therapy chamber 50 receives chilled air from the air supply conduit 36 into a
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`distribution manifold 38 having at least one nozzle configured to supply chilled air to an interior
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`52 of the chamber 50.
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`In the depicted embodiment, three different nozzle locations are
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`provided for supplying air from the manifold 38, including a first nozzle 54 for supplying chilled
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`airto a lower portion of the chamber interior 52, a second nozzle 58 for supplying chilled air to
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`an upper portion of the chamber interior 52, and a third nozzle 56 for supplying chilled airto an
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`intermediate portion of the chamber interior 56, it being understood that any number and
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`location of nozzles may be used to enable the chamber 50 to provide targeted and customized
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`cryotherapy to various parts ofthe patient’s body.
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`In addition, nozzles can be positioned all on
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`one side of a patient’s body, or at any point around the chamber surrounding the patient’s body.
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`Individually controlled baffles or valves (not shown) may be provide so that each nozzle can be
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`turned on or off, or modulated, during all or a portion of each cryotherapy treatment session.
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`[0061] Warmed air from the therapy chamber 50, having passed overthe patient’s body
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`thereby taking on heat, is drawn out of an upper portion ofthe therapy chamber 50 through the
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`air return conduit 40.
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`It is understood that because of the non-sealed nature of the therapy
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`chamber 50, the recirculating air operates in a nearly closed but slightly open loop; while a
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`small percentage of the chilled air provided by the air supply conduit 36 may escape from the
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`chamber 50, a commensurate amount of make-up or fresh air will be drawn into the air return
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`conduit 40 to maintain a substantially consistent amount of recirculating air flow for a given
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`speed of the variable speed fan 32. Also, provisions can be made to remove moisture from the
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`recirculating air as necessary.
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`[0062] Alternatively, chilled air can be flowed from the heat exchanger 24 into an upper
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`portion of the therapy chamber 50 through the air return conduit 40, and then drawn into the
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`nozzles 52, 54, and 56 for return to the heat exchanger 24 via the manifold 38 and the air
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`supply conduit 36 (reverse flow operation), which may be advantageous for certain types or
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`modes of therapy, and would provide a further option for customization of treatment protocols.
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`This can be accomplished by a second fan (not shown) or by making the fan 32 reversible, or
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`by valves or dampers or other similar mechanisms.
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`[0063] Operation ofthe cryotherapy apparatus 10 is controlled by a specially-programmed
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`controller 100. A temperature sensor 34, or multiple temperature sensors 34 with the values
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`averaged or selectively combined in a weighted or non-weighted formula, detects a
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`recirculating airtemperature and provides that temperature to the controller 100. The
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`temperature sensor 34 may be mounted in a lower portion of the exchanger enclosure 20
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`upstream of the fan 32 as shown, or it may be positioned in the air return conduit 40.
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`In one
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`embodiment, the controller 100 is programmed to control the recirculating airtemperature
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`within a predetermined treatment range by regulating the speed of the fan 32, and thus
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`controlling the recirculating air flow rate.
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`[0064]
`