Patent Publication Number: US-2022218519-A1

Title: Appendage Cooling and Heating System and Method of Use

Description:
1. FIELD OF THE INVENTION 
     The present application relates generally to health treatments. In particular, the present application relates to an appendage cooling and heating system for allowing a thermos-regulator, such as ice or hot water, to be removably placed near a hand, foot, or other body areas. 
     2. DESCRIPTION OF RELATED ART 
     Thermotherapeutical applications and treatments are often recommended as prophylactic measures for those who are experiencing malaise, pain, are ill, or are injured. For example, it is known that heat can increase circulation, bringing an increased flow of blood and nutrients to a specific area of the body. In contrast, cooling treatments slow the blood flow, and may be prescribed to reduce pain and swelling and prevent further injury in athletics, recuperative training, post-cardiovascular procedures, and with homeopathic remedies. 
     The epidemiology of many injuries, diseases, and illnesses that respond to thermotherapeutical applications can be extremely complex. For example, the epidemiology of nail toxicity and peripheral neuropathy is extremely complex due to the unpredictability and complexity of the nervous system. Although it is known that chemotherapy-induced peripheral neuropathy (CIPN) results from prolonged chemotherapy drugs and systemic treatments, because each patient is unique as well as their reaction to the various types of drugs and treatments, the effective preventative measures prescribed prior to the onset of CIPN are relatively unproven or may vary in intensity, duration, and individual effect. 
     Certain symptoms are common among athletes, patients, or those experiencing malaise prior to being diagnosed as having a specific illness, injury, nail toxicity, or CIPN. Those common symptoms include tingling sensations, sharp, stabbing pain, throbbing, or burning and/or shock-like sensations. Fingertips, hands, feet, limbs, and joints are generally the affected areas affected. 
     Prophylaxis and preventative measures for injuries, illnesses, or diseases that respond to thermotherapeutical applications are limited. For example, patients prescribed chemo therapy treatments may receive multiple one- to three-hour intravenous (IV) infusions. Although studies have indicated that thermotherapeutical applications before, during, and/or after these IV infusions may help reduce and/or prevent nail toxicity and minimize the damaging effects of CIPN, the types of applicators and methods of use are often bulky, inefficient, and costly. 
     The prophylactic and preventative thermotherapeutical applications currently available include submersion in ice tubs or topical application of cold packs, including frozen gel packs, instant cold packs that are crush-activated, and form-fitting freezer gloves and mittens. Gel packs retain their desired temperature for a limited time, and then are unavailable while they are re-frozen. Care facilities must maintain adequate freezer space for each pack per patient for this type of treatment. Crush-activated packs also require additional storage space, and are one-and-done solutions that must be properly disposed of after use. Form-fitting frozen gloves and mittens may cause pain during appendage entry, insertion, and removal, they do not provide adequate room for rotating of appendages or brief removal from the cold surfaces to warmer ambient conditions, and those made with fabric must be sterilized if they are to be re-used by another patient due to the fibers and germ-carrying properties of fabrics. 
     Although the aforementioned prophylactic and preventative measures represent great strides in the field of thermotherapeutical applications, treatments, and therapy, many shortcomings remain. 
     Hence, there is a need for a thermotherapeutical application that may increase the effectiveness of preventative measures related to recuperative training, athletic injuries, CIPN, nail toxicity, and other chemo therapy side effects. There is an additional need to reduce therapy complications, cost, waste, and storage requirements of current solutions and prophylactic measures in the field of thermotherapeutical applications. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
       The novel features believed characteristic of the invention are set forth in the appended claims. However, the invention itself, as well as a preferred mode of use, and further objectives and advantages thereof, will best be understood by reference to the following detailed description when read in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is a front elevational view of a preferred embodiment of an appendage cooling and heating system, according to the present application; 
         FIG. 2  is a front elevational view of a joint of the appendage cooling and heating system of  FIG. 1 ; 
         FIG. 3  is a top view of a ring for forming the joint of  FIG. 2 ; 
         FIG. 4  is an alternative embodiment of a joint of an appendage cooling and heating system, according to the present application; 
         FIG. 5A  is front elevation view of an alternative embodiment of an appendage cooling and heating system, according to the present application; 
         FIG. 5B  is a top view of the appendage cooling and heating system of  FIG. 5A ; 
         FIG. 5C  is a section view of the appendage cooling and heating system of  FIG. 5A  taken along Section Line  5 C; 
         FIG. 5D  is an exploded view of a joint of the appendage cooling and heating system of  FIG. 5A ; 
         FIG. 6  is an assembly view of an alternative embodiment of an appendage cooling and heating system, according to the present application; 
         FIG. 7  is a cross-sectional top view of an alternative embodiment of an appendage cooling and heating system, according to the present application; 
         FIG. 8  is a cross-sectional top view of an alternative embodiment of an appendage cooling and heating system, according to the present application; and 
         FIG. 9  is a flowchart of a preferred method of use, according to the present application. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to  FIG. 1  in the drawings wherein like reference characters identify corresponding or similar elements throughout the several views, an appendage cooling and heating system  101  is illustrated. Cooling system  101  includes a body  103 , an appendage opening  105  for receiving an appendage, such as a hand, foot, finger, or limb. The body  103  includes an inner layer  107  and an outer layer  109 , which are connected together by a joint  111 . Between the inner layer  107  and the outer layer  109  is an interstitial space  113  for containing a reusable, cost-effective heat sink medium (see  FIG. 5 , below), such as ice. 
     It is important to note that ice machines are usually found on the premises of care facilities for a wide variety of purposes. Large quantities of ice can be produced by a single ice machine. Melted ice is easily disposed of, environmentally friendly, and easily exchanged when temperatures are no longer adequate to produce the desired effect. 
     In a preferred embodiment, the appendage opening  105  is elongated or elliptical in shape. For example, the major axis of the opening may be approximately 10-15% longer than the minor axis of the opening. 
     In a preferred embodiment, the joint  111  is made from an upper ring  117  nested within a lower ring  119 . In a preferred embodiment, the upper ring  117  and the lower ring  119  are identical in shape and design, just rotated, such that one ring fits on top of the and partially within the other. For example, the upper ring  117  has protruding portions inserted in corresponding recessed portions of the other. In a preferred embodiment, the upper and lower rings  117 ,  119  snap together. Alternatively, the rings  117 ,  119  are connected together to form joint  111  by threaded attachment, clasps, tabs, interlocking flanges, and combinations thereof. 
     Referring now to  FIG. 2  in the drawings, a side elevation view of the joint  111  is illustrated. Although not shown in  FIG. 2 , the inner and outer layers  107 ,  109  are adhered to portions of the upper and lower rings  117 ,  119 . Preferably, a heat fusion weld or an ultrasonic welding process is used to adhere the layers to at least one of a trough, a ridge, or a cuff of the respective ring  117  or  119 . 
     Referring now to  FIG. 3  in the drawings, in a preferred embodiment, the lower ring  119  includes at least one annular trough  321  located on a top side of the ring. The annular trough  321  is collinearly aligned with at least one annular ridge (see  FIG. 5C , below) located on an underside of the ring. Preferably, the ring  119  includes multiple troughs  321  on one side and multiple ridges on the opposite side with two or more ridges and troughs that are collinearly aligned in each side. The shape of the troughs and ridges may vary, including circular, elliptical, and square shaped designs. In general, the shapes of the troughs and ridges are similar in shape to the ring itself, and are therefore preferably elliptically shaped. The shape of the sidewalls of the troughs and ridges may vary, including bulbous, rounded, straight-edged, and angled shapes. Preferably, at least one annular ridge has a bulbous shape that includes a curved head portion, a transition portion, and a narrow neck portion is used. This ensures a primary interlock when the at least one annular ridge is inserted into a correspondingly shaped, annular, collinear trough. 
     In a preferred embodiment, a trough  321  has a slightly larger dimension than a corresponding, collinear ridge. For example, a trough may have a width that is 8-12% wider than a width of the corresponding, collinear ridge. 
     In at least one embodiment, a trough  321  is configured to receive another ring to create a seal for the joint  111 . For example, the trough  321  may be sized to receive an O-ring or a gasket within the trough, such that pressure between it, a surface of a ring  117  or  119 , and at least one of the layers  107 ,  109  creates the seal for the joint  111 . 
     In a preferred embodiment, the rings  117 ,  119  are made of a plastic material, such as polyethylene, which has a similar or identical melting point as the material used to form the inner and outer layers  107 ,  109 . Preferably, the material used for the layers  107 ,  109  and the rings  117 ,  119  are identical in composition, such that both are made from a single, water-tight material, such as polyethylene or polypropylene, but with different material thicknesses. Alternatively, other plastics, elastomers, material blends, or moldable and/or extruded materials may be used such as polytetrafluoroethylene (Teflon or PTFE), silicon, and pliable polymer-dipped metal/wire frame materials. It is noted that when the alternative materials are used, an adhesive may be used instead of a heat/ultrasonic weld to adhere the inner and outer layers  107 ,  109  to the upper and lower rings  117 ,  119 . In at least one embodiment, both an adhesive and a heat/ultrasonic weld are used. The adhesive includes an environmentally friendly polymer adhesive, such as poly(propylene-co-glycidyl butyrate carbonate) or PPGBC. 
     In a preferred embodiment, the ring  119  includes a protruding tab  325  opposite a recess  327  in the ring  119 . Preferably, both the tab  325  and the recess  327  are formed in the unitary structure of the ring  119 . The tab  325  and the recess  327  of a first ring correspondingly fit within the tab and recess of a second ring. For example, once the second ring is rotated and oppositely oriented, the tab  325  fits within recess  327 . This provides a secondary interlock to the rings of the joint  111  and also provides a user-friendly separation mechanism. 
     In at least one embodiment, tab  325  has both a raised, keyed portion on a top side of the tab and a recessed receiving portion on its underside, such that the raised, keyed portion of another tab of a second ring fits within the recessed portion on the underside of the first ring. The the raised key-like portion extends above the remainder of the surface of tab  325 . Although the raised portion is depicted as being located on a top side of the tab  325 , alternatively the tab  325  may be configured to have a recessed portion located on the top side of the tab  325 , where the recessed portion receives a raised portion of a tab of a second ring. In these embodiments, the recess  327  may be optional, as the ring  119  could have two tabs positioned opposite each other, or multiple tabs positioned around a circumference of the ring  119 . 
     In at least one embodiment, the shape of the lower ring  119  is elliptical, having a substantially flat top surface where the only sloping parts are located in the troughs and ridges of the ring. Alternatively, the top surface of the lower ring  119  slopes concentrically inward, creating a coned-disc shape, or a conical spring washer shape similar to a Belleville washer. 
     In at least one embodiment, the ring  119  is formed with a cuff  329  extending out and away from the top surface. Preferably, the cuff  329  is formed concentrically sloping inward at a different angle than the slope of the top surface of the ring  119 . For example, the cuff  329  is formed at a 90° angle relative to a plane parallel to the top surface, By way of another example, the cuff  329  is formed at a 10°, 15°, 20°, 25°, or 30° angle relative to a plane parallel to the top surface. 
     Preferably, the cuff  329  interacts with a layer  107  or  109  adhered within the annular trough  321 . For example, the outer layer  109  may be adhered both within the annular trough  321  and to at least a portion of an intrados surface of the cuff  329 , In at least one embodiment, the inner layer  107  is inserted through an appendage opening and is wrapped completely around an O-ring that fits within the lower ring  119 , such that a portion of the material making up the inner layer  107  is folded onto itself around the O-ring. 
     In at least one embodiment, a single sheet of layer  107  or  109  is adhered to the lower ring  119  without any sublayers or overlaps. Alternatively, an end of the single sheet of material making up the outer layer  109  is rolled and/or folded onto itself to form multiple sub-layers, and the multiple sub-layers created by the rolling and/or folding are adhered within the trough  321 . 
     Referring now to  FIG. 4  in the drawings, an assembly view of an alternative embodiment of a joint  411  is illustrated. The alternative joint  411  is formed of two sets of rings, where a ring in each set is different from another ring in the set relative to at least one of: 1) material composition, 2) shape, 3) size, 4) dimension, and 5) number of corresponding, collinear troughs and/or ridges. An interlocking ring  419  of the joint  411  includes a series  421  of troughs and ridges. A bag-holding ring  417  is nested within the innermost circumference of the interlocking ring  419 . The series  421  of troughs and ridges of the interlocking ring  419  mate with another series of troughs and ridges of an interlocking ring of the second set of rings. Thus, two sets of interlocking rings  419  and bag-holding rings  417  form the joint  411 . The seal for joint  411  in this embodiment is created by pressure and tension. For example, either the cuff  429  of the lower ring  419  tapers, or the nested ring  417  tapers, such that the ring  417  and its attached inner layer  107  are wedged inside the cuff  429 . The tension from being wedged creates the seal for the joint  411 . 
     In an alternative embodiment, both rings  417  and  419  are bag-holding rings, and joint  411  is formed by inserting ring  417  within a portion of the ring  419 , and this insertion alone creates the seal for joint  411 . For example, the lower ring may include four or more troughs and ridges in the series  421 , and the nested ring  417  has only half as many correspondingly shaped, collinear troughs and ridges. The inner layer  407  is wrapped through the opening in ring  417  and around each of its troughs and ridges. These troughs and ridges having material wrapped around them snap into and between at least two of troughs and ridges of the series  421  of troughs and/or ridges of the lower ring  419 . The extra troughs and ridges of the series  421 , i.e., that are not used to receive inner layer  407  and ring  417 , may optionally be used with a second set of rings and a second outer layer, such that the body of the system has at least three layers. 
     In a preferred embodiment, the sidewalls of the troughs and ridges of the series  421  are slightly angled based on a desired interaction with another ring having a second series of troughs and ridges. For example, an inner ridge is angled inward or towards the inserted appendage, while the outermost ridge, i.e., ridge with largest circumference, is angled outward or away from the inserted appendage. Corresponding troughs of a second or a third ring may be similarly angled to increase tension between sidewalls of troughs and/or ridges and thereby increase the effectiveness of the seal. 
     The nested elliptically shaped ring  417  may be rigid, semi-rigid, or flexible. The ring  417  has a circumference that is slightly larger than the inner circumference of the lower ring  419 , further enabling the seal of joint  411 . 
     Referring now to  FIGS. 5A through 5D  in the drawings, an alternative embodiment of an appendage cooling and heating system  501  having joint  411  is illustrated. Cooling system  501  includes a body  503 , an appendage opening  505  for receiving an appendage, such as a hand, foot, finger, or limb. The body  503  includes an inner layer  507  and an outer layer  509 , which are connected together by the joint  411 . Between the inner layer  507  and the outer layer  509  is an interstitial space  513 . Although the layers  507 ,  509  are preferably adhered to an innermost trough  521 , alternatively the layers  507 ,  509  are adhered within any of the troughs  521  or onto any of the ridges  523  of the series  421  of annular troughs and ridges. 
     Referring specifically now to  FIG. 5D  in the drawings, an exploded view of the joint  411  is illustrated. In a preferred embodiment, the joint  411  is made from an inner/upper ring  417  nested within a lower ring  419 , where the lower ring has at least one annular trough  521  and a correspondingly shaped, collinear annular ridge  523 . 
     A rounded tab  533  is formed at the end of the cuff  429 . The outer layer  509  of system  501  is attached to at least one of an annular trough  521 , the rounded tab  533 , and the cuff  429 . In at least one embodiment, two identically shaped upper and lower rings  419  are snapped together, and the rounded tab  533  of the respective upper and lower rings provide a second location at which a user may separate the rings from each other—the first location being the tab  525  and recess  527 . 
     In the appendage cooling and heating system  501 , preferably, at least one of the annular ridges  523  has a groove or a notch  520  cut or otherwise formed therein. For example, the groove or notch  520  may have angled sides that come to a point at one end of the ridge  523 , and be open and spaced apart at the other end. The sides of the ridge  523  receive pressure from inserting the ridge into a corresponding trough of another ring and the groove or notch  520  provides room to contract the sides of the ridge  523 . 
     Referring now to  FIG. 6  in the drawings, an assembly view of an alternative embodiment of an appendage cooling and heating system  601  using joint  411  and using a third ring  617  is illustrated. The appendage cooling and heating system  601  uses two rings to form a joint  411  similar to the joint depicted in  FIG. 5D . In a preferred embodiment, only the ring  419  and the ring  417  have bags, or respective inner and outer layers  507 ,  509  attached to them. Alternatively, each of the rings  417  and  419  have respective inner layers attached to the respective rings, while the third ring  617  has outer layer  609  attached to the third ring  617 . In this embodiment, various combinations of snapping, wedging, and nesting of rings are obtainable depending on the shape, size, dimension, and trough/ridge configuration of the respective rings. For example, two rings may be nested within a third ring, snapping troughs and ridges of the two rings to correspondingly shaped troughs and ridges of the third ring. By way of another example, one ring may be nested within a second ring, while the third ring is used as a wedge ring to wedge inside the inner circumferences of the other two rings. Multiple different combinations and variations will be recognized by those skilled in the art, and each of the various combinations are encompassed by the present application. 
     Referring now to  FIG. 7  in the drawings, an alternative embodiment of an appendage cooling and heating system  701  is illustrated. System  701  includes a body  703  and an appendage opening  705  that is configured to fit over and around an appendage. The body  703  includes an inner layer  707  removably attached to an outer layer  709  via a joint  711 . Between the inner layer  707  and the outer layer  709  exists an interstitial space  713 , wherein a thermo-regulator  715  is held. Although the interstitial space  713  appears to be in the form of a mitten, or generally in the shape of a hand, preferably seams and/or fold lines are removed such that the inner layer is not formed into the shape of a mitten. However, in some embodiments, a sleeve, tube, or sock-like shape is used. These shapes may be conducive to a leg, arm, foot, and/or hand without restricting movement within the body  703 . 
     In use, the outer layer  709  is removed via a separation of the joint  711  in order to place the thermo-regulator material  715  within the interstitial space  713 . Using the appendage opening  705 , the inner layer  707  is placed over the appendage of the user. The outer layer  709  is filled with the thermo-regulator material  715 , and then placed over the inner layer  707  and secured at the joint  711 . 
     Preferably, the components of the joint  711  snap together. Alternatively the joint  711  may comprise a twist lock, fastener, or another method of sealing the interstitial space  713 , making it water-tight. 
     It is important to note that once the temperature differential between the heat sink  715  and the appendage or the ambient air has equilibrated or is nullified, the inner layer  707  remains intact and does not need to be removed from the appendage or its ring in order to replace the thermo-regulator material. Only the outer layer and ring need be removed in order to replace or refill the thermo-regulator material. 
     Referring now to  FIG. 8  in the drawings, an alternative embodiment of an appendage cooling and heating system  801  is illustrated. Cooling system  801  includes a body  803  and an appendage opening  805 . An access point  808  having a threaded joint  811  is disposed at an end opposite the appendage opening  805 . The access point  808 , such as a threaded plug, may be removed to access interstitial compartment  813 , where the thermo-regulator material  815  is stored adjacent a compartment attached to appendage opening  805  in which an appendage  850  is inserted. 
     Referring now to  FIG. 9  in the drawings, a method  901  of cooling an appendage, is illustrated. 
     Step  903  includes placing an appendage in the body of an appendage cooling and heating system so as to protect the appendage by a first layer of the cooling system. For example, a hand is inserted into appendage opening  105  inside inner layer  107 . 
     Step  905  includes adding a thermo-regulator material to a portion of the body of the appendage cooling and heating system. For example, the outer layer  109  is partially filled with a heatsink, such as ice and/or cold water, or with a heat source, such as hot water. 
     Step  907  includes sealing or interlocking rings of the body of the appendage cooling and heating system such that the thermo-regulator material is contained without leaking. For example, an inner ring  117  may interlock with a lower ring  119 , with the pressure of cuffs and/or angled interlocking troughs and ridges providing a water-tight seal at joint  111 . 
     Step  909  includes facilitating the absorption, or equilibrating, of a heat differential from the body of the appendage cooling and heating system into the thermo-regulator material. For example, although thin fabric gloves may be worn by the hand of the user that is inserted into appendage opening  105 , the user is careful that thick fabric or excessive insulation is not applied to the appendage within appendage opening  105 . 
     Step  911  includes refreshing the thermo-regulator material when the heat differential between the thermo-regulator and the appendage or the ambient air within the body of the cooling system has equilibrated or been nullified. For example, the capacity of the ice  815  to cool the appendage may be exhausted when the ice  815  has completely melted. At this point, the user may or may not remove their hand from the body  803  of cooling system  801  as the interstitial compartment  813  is refilled with ice  815 , and the body is resealed. In at least one embodiment, leaving the hand in the body  803  while refreshing the ice is optional. 
     It is noted that methods of manufacture may include extrusion techniques, extension of materials onto a mandrel to form a material such as for a bag/layer, reverse vacuum and/or heat sealing to attach a bag/layer to a ring, dissolving or collapsing the mandrel to remove the mandrel from the formed materials, folding or rolling the formed materials, vacuum sealing for storage, packing, and shipment, and other similar processes. The order and exact recitation of these steps is not meant to be limiting, as those skilled in the art will recognize reordering, modifications, and/or combinations of these steps, each of which are intended to be encompassed by the present application. 
     It is apparent that an invention with significant advantages has been described and illustrated. Although the present application is shown in a limited number of forms, it is not limited to just these forms, but is amenable to various changes and modifications without departing from the spirit thereof.