The effect of temperature on the human body has been well documented and the use of targeted temperature management (TTM) systems for selectively cooling and/or heating bodily tissue is known. Elevated temperatures, or hyperthermia, may be harmful to the brain under normal conditions, and even more importantly, during periods of physical stress, such as illness or surgery. Conversely, lower body temperatures, or mild hypothermia, may offer some degree of neuroprotection. Moderate to severe hypothermia tends to be more detrimental to the body, particularly the cardiovascular system.
Targeted temperature management can be viewed in two different aspects. The first aspect of temperature management includes treating abnormal body temperatures, i.e., cooling the body under conditions of hyperthermia or warming the body under conditions of hypothermia. The second aspect of thermoregulation is an evolving treatment that employs techniques that physically control a patient's temperature to provide a physiological benefit, such as cooling a stroke patient to gain some degree of neuroprotection. By way of example, TTM systems may be utilized in early stroke therapy to reduce neurological damage incurred by stroke and head trauma patients. Additional applications include selective patient heating/cooling during surgical procedures such as cardiopulmonary bypass operations.
TTM systems circulate a fluid (e.g., water) through one or more thermal contact pads coupled to a patient to affect surface-to-surface thermal energy exchange with the patient. In general, TTM systems include a TTM fluid control module coupled to at least one contact pad via a fluid deliver line. One such thermal contact pad is disclosed in U.S. Pat. No. 6,197,045 titled “Cooling/heating Pad and System” filed Jan. 4, 1999, which is incorporated herein by reference in its entirety.
Applying the thermal contact pad to a non-flat surface of a patient can in some instances interrupt or inhibit thermal energy exchange with the patient due to poor thermal contact with the patient. Disclosed herein are embodiments of thermal contact pads and methods for maximizing thermal energy exchange with the patient over the contact area of the thermal contact pad.
Briefly summarized, disclosed herein is a medical pad for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient. According to some embodiments, medical pad includes a fluid containing layer configured for circulation of a TTM fluid therein, where the fluid containing layer disposed between a top side of the medical pad and a patient contact side of the medical pad. The pad further includes one or more of: (i) a bistable stiffening structure disposed along the top side of the pad; (ii) a compressible foam layer disposed between the fluid containing layer and the patient contact side; (iii) a stretchable band coupled with the fluid containing layer, the band configured to secure the pad to the patient; or (iv) a semi-permeable layer disposed along an underside of the fluid containing layer, the semi-permeable layer configured to provide for TTM fluid migration from the fluid containing layer toward the patient contact side.
In some embodiments, the pad includes the bistable stiffening structure disposed along the top side of the pad. The bistable stiffening structure is transitionable between a first stable shape and a second stable shape. The bistable stiffening structure may be disposed in the first stable shape prior to applying the pad to the patient, and transitioned away from the first stable shape after applying the pad to the patient.
In some embodiments, the bistable stiffening structure causes the pad to extend at least partially around the patient when the bistable stiffening structure is transitioned away from the first stable shape. The bistable stiffening structure may cause the pad to exert a compressive force on the patient when the bistable stiffening structure is transitioned away from the first stable shape.
In some embodiments, the pad includes the compressible foam layer and the compressible foam layer may include a thermal conductivity greater than 0.4 W/m-K, and the compressible foam layer may be disposed between the fluid containing layer and a hydrogel layer. In some embodiments, the bistable stiffening structure causes a compression of the compressible foam layer.
In some embodiments, the pad includes the stretchable band, where the stretchable band includes: a first band extension, extending away from the fluid containing layer in a first direction; and a second band extension, extending away from the fluid containing layer in a second direction opposite the first direction, and where the first band extension and/or the second band extension are configured to wrap around the patient. In some embodiments, the stretchable band is configured self-adhere to itself. In some embodiments, the stretchable band is disposed over a topside fluid containing layer and/or disposed along an underside fluid containing layer.
In some embodiments, the pad includes the semi-permeable layer and the semi-permeable layer may be coupled with fluid containing layer so that the semi-permeable layer is in fluid communication with the fluid containing layer. In some embodiments, TTM fluid from the fluid containing layer migrates through the semi-permeable layer. In some embodiments, the pad further includes a hydrogel layer, and during use, the hydrogel layer receives TTM fluid from the semi-permeable layer.
In some embodiments, the pad defines a first permeability located along a perimeter portion of the semi-permeable layer and a second permeability located within a central portion of the semi-permeable layer, and the first permeability is greater than the second permeability.
In some embodiments, the semi-permeable layer includes one or more pockets, where each pocket is fluidly coupled with the fluid containing layer via a fluid passageway.
Also disclosed herein is a method of providing a targeted temperature management (TTM) therapy to a patient. According to some embodiments, the method includes providing a thermal contact pad that includes a fluid containing layer having a TTM fluid circulating therethrough, where the fluid containing layer is disposed between a top side of the medical pad and a patient contact side of the medical pad. The pad further includes one or more of (i) a bistable stiffening structure disposed along the top side of the pad, (ii) a compressible foam layer disposed between the fluid containing layer and the patient contact side, (iii) a stretchable band coupled with the fluid containing layer, the band configured to secure the pad to the patient, (iv) a semi-permeable layer disposed along an underside of the fluid containing layer, the semi-permeable layer configured to provide for TTM fluid migration from the fluid containing layer toward the patient contact side. The method further includes applying the pad to the patient.
In some embodiments of the method, the pad includes the bistable stiffening structure, where the bistable stiffening structure includes transition shape disposed between a first stable shape and a second stable shape, and the method further includes applying a force to the pad to transition the bistable stiffening structure away from the first stable shape across the transition shape toward the second stable shape. In some embodiments, the bistable stiffening structure causes the pad to extend at least partially around the patient when the bistable stiffening structure is transitioned toward the second stable shape, and in some embodiments, the bistable stiffening structure causes the pad to exert a compressive force on the patient when the bistable stiffening structure is transitioned toward the second stable shape.
In some embodiments of the method, the pad includes the compressible foam layer, where the compressible foam layer has a thermal conductivity greater than 0.4 W/m-K, and the compressible foam layer may be disposed between the fluid containing layer and the patient.
In some embodiments of the method, the pad includes the stretchable band, and the stretchable band includes: a first band extension, extending away from the fluid containing layer in a first direction; and a second band extension, extending away from the fluid containing layer in a second direction opposite the first direction, and the method includes wrapping the first band extension and/or the second band around the patient. In some embodiments, the stretchable band is configured self-adhere to itself.
In some embodiments of the method, the pad includes the semi-permeable layer, and a hydrogel layer, where the semi-permeable layer is fluidly coupled between the fluid containing layer and the hydrogel layer so that TTM fluid from the fluid containing layer migrates through the semi-permeable layer to the hydrogel layer. In some embodiments the semi-permeable layer defines a first permeability located along a perimeter portion of the semi-permeable layer and a second permeability located within a central portion of the semi-permeable layer, where the first permeability is greater than the second permeability. In some embodiments, the semi-permeable layer includes one or more pockets, where each pocket is fluidly coupled with the fluid containing layer via a fluid passageway.
These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and the following description, which describe particular embodiments of such concepts in greater detail.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. The words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.” Furthermore, the terms “or” and “and/or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and/or C” mean “any of the following: A; B; C; A and B; A and C; B and C; A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.
The phrases “connected to” and “coupled to” refer to any form of interaction between two or more entities, including mechanical, fluid, and thermal interaction. Two components may be connected to or coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.
Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
The pad 100 may generally define a rectangular shape. In other embodiments, the pad 100 may define shapes other than rectangular such as circular, oval, or a shape that matches or aligns with a shape of the human body. The pad 100 may be configured to accommodate curves of the patient body. The pad 100 includes a bistable stiffening structure 120 to define a curvature of the pad 100 in accordance with a body part such as a leg or torso, for example. The stiffening structure 120 is specifically configured to cause the pad 100 to extend around (e.g., partially around) the body part and define a contact force between the pad 100 and the body part to enhance the thermal energy exchange with the patient P.
Although not required in some embodiments, the pad 100 may include additional layers. In some embodiments, the pad 100 may include a thermal conduction layer 132, a hydrogel layer 133, and a hydrogel liner 134 which are each disposed between the fluid containing layer 131 and the underside 106. The thermal conduction layer 132 separates the TTM fluid 102 within the fluid containing layer 131 from a hydrogel 133A within the hydrogel layer 133 and facilitates thermal conduction between the TTM fluid 102 and the hydrogel 133A. The hydrogel layer 133 facilitates thermally intimate contact of the fluid containing layer 131 and the patient P. The hydrogel liner 134 is applied to the underside of the hydrogel layer 133 during manufacturing to cover the hydrogel layer 133 and encapsulate the hydrogel 133A. In use, the clinician may remove hydrogel liner 134 from the hydrogel layer 133 to expose the hydrogel 133A, thereby allowing the hydrogel 133A to contact the skin of the patient P directly. The pad 100 may also include an insulation layer 130 along the topside 105 to thermally isolate the fluid containing layer 131 from the surrounding environment. In some embodiments, the stiffening structure 120 may be disposed between the insulation layer 130 and the fluid containing layer 131. In other embodiments, the stiffening structure 120 may be positioned atop the insulation layer 130.
The bistable nature of the stiffening structure 120 provides for the pad 100 to be transitioned between the first stable shape 101 and the second stable shape 103. The stiffening structure 120 may define a transition shape 102 as shown with dotted lines in
In use, the pad 100 may be disposed in the first stable shape 101 when the pad 100 is not applied to the patient and further disposed toward the second stable shape 103 when the pad 100 is applied to the patient. In some embodiments, the pad 100 may be selectively (including repeatedly) transitioned between the first stable shape 101 and the second stable shape 103.
The bistable stiffening structure 120 may include any suitable structural components to define the bistable functionality of the bistable stiffening structure 120. By way of one example, the bistable stiffening structure 120 may include one or more bistable spring strips 121 extending across the pad 100 (see
According to one method of use, the clinician may position the pad 100 adjacent the patient P at a desired location. The clinician may then transition the pad 100 from the first stable shape toward the second stable shape to cause to the pad 100 to wrap around the body part. The clinician may then initiate the thermal energy exchange process in accordance with operation of the TTM module 10. Thereafter, the clinician may urge the pad 100 toward the first stable shape to remove the pad 100 from the patient. In some embodiments, the clinician may transition the pad 100 into the first stable shape.
The thermal foam layer 225 in composed of a thermally conductive foam (foam) 225A. The foam 225A is configured to conduct thermal energy (heat) between the fluid containing layer 231 and the patient P. The hydrogel layer 233 facilitates an intimate thermal contact between the thermal foam layer 225 and the patient P. In some embodiments, the foam 225A may be composed of a reticulated foam material. As discussed above, the foam 225A is configured to facilitate thermal energy exchange across the thermal foam layer 225. As such the foam 225A may be specifically configured to conduct heat and thus may include a thermal conductivity within the range of 0.4 to 0.7 W/m-K (watts per meter-Kelvin).
In the illustrated embodiment, a central portion 341 of the stretchable band 340 extends across a topside 305 of the pad 300. However, in some embodiments, the first and second band extensions 342, 343 may be coupled to opposite edges of the fluid containing layer 331 and as such, the central portion 341 of the stretchable band 340 may be omitted. In the illustrated embodiment, a bottom portion 345 of the stretchable band 340 extends across an underside 306 of the pad 300.
The band 340 is composed of a stretchable material that defines a tension when stretched. The band 340 is configured to extend around a body part in a stretched state so that the tension force secures the pad 300 to the patient. The band 340 is also composed of a self-adhering material. In other words, the band 340 (or more specifically the band material) is configured to adhere to itself without an added adhesive. The self-adhering feature of the band 340 may also facilitate an adherence of the band 340 to the patient's skin.
Although not shown, the pad 300 may include any or all of the additional layers shown and described in relation to the pad 100. In other words, in some embodiments, the pad 300 may include a thermal conduction layer, a hydrogel layer, a hydrogel liner and/or an insulation layer. For example, the pad 300 may omit the bottom portion 345 of the stretchable band 340 and include a hydrogel layer in place thereof.
In use, the clinician may position the pad on the patient at a desired location. Thereafter, the clinician may stretch the band to establish a tension in the band and wrap one or both band extension around the patient.
The semi-permeable layer 450 is composed of a material (e.g., a foam material) that is semi-permeable to water. In other words, semi-permeable layer 450 provides for a migration of water from the fluid containing layer 431 to the hydrogel layer 433 at a rate that maintains an appropriate concentration of water within the hydrogel 433A.
In some embodiments, although not required, the semi-permeable layer 450 may include one or more pockets 452 that are fluidly coupled with the fluid containing layer 431 via a fluid passageway 453. The pockets 452 may contain a volume of TTM fluid 102 (water) from the fluid containing layer 431 to facilitate the migration of water through the semi-permeable layer 450. The number and location of the pockets 452 may define a desired permeability 451 across the semi-permeable layer 450 as further described below. In some embodiments, the permeability 451 may be defined by the material of the semi-permeable layer 450. In other embodiments, the semi-permeable layer 450 may include a semi-permeable membrane (not shown) disposed across the semi-permeable layer 450, such as adjacent a bottom side 456 of the semi-permeable layer 450, for example.
As discussed above, each of the illustrated embodiments of pads 100-400 includes one or more features that are not included in the illustrated embodiments of the other pads. However, other embodiments of the pads 100-400 may include any or all features of the other pads or any combination of the features described in relation to the pads 100-400.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.
This application claims the benefit of priority to U.S. Provisional Application No. 63/292,319, filed Dec. 21, 2021, which is incorporated by reference in its entirety into this application.
Number | Date | Country | |
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63292319 | Dec 2021 | US |