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.
As these and other medical applications have evolved, the accommodation of different patient sizes has become more important. Disclosed herein are embodiments of devices and methods for the adjusting the patient contact area of the thermal pad to better accommodate patients of different sizes.
Briefly summarized, disclosed herein is a medical pad for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient. The pad includes a central pad defining a top end and a bottom end, where the central pad is configured for placement on a back side of the patient. The pad further includes a plurality of extension pads coupled with the central pad, where the extension pads extend away from right and left lateral sides of the central pad, and each extension pad is coupled with the central pad via a neck extending between the extension pad and the central pad. The central pad may be sized to extend laterally across the back side of the patient and downward along the legs of the patient.
The pad may include a slit, where the slit (i) is disposed centrally between the right and left lateral sides of the central pad, (ii) extends upward away from the bottom end of the central pad, and (iii) extends between a top side and an underside of the central pad.
The pad may include indicia disposed on the top side of the central pad, and the indicia may include an alignment indicium to aide in applying the central pad to the back side of the patient.
The pad further includes a fluid containing layer configured for circulation of a TTM fluid therein, and the fluid containing layer includes at least one delivery flow path and at least one return flow path extending along each neck. The fluid containing layer may include a fluid free zone, where the fluid free zone is disposed centrally between the right and left lateral sides of the central pad, and the fluid free zone extends downward away from the top end of the central pad.
The pad may further include (i) an insulation layer disposed on a top side of the fluid containing layer, (ii) a hydrogel layer disposed on an underside of the fluid containing layer, and (iii) a hydrogel liner coupled with the hydrogel layer on an underside of the hydrogel layer.
In use, the hydrogel layer may be disposed in direct contact with a skin of the patient. The hydrogel liner may include one or more separation lines, where the separation lines (i) extend laterally across the central pad between the right and left lateral sides of the central pad, and (ii) facilitate separation of the hydrogel liner into two or more portions of the hydrogel liner. In use, at least one portion of the hydrogel liner is removed from the pad, and at least one other portion of the hydrogel liner may remain coupled with the pad.
In some embodiments, one or more extension pads are rotatable with respect to the central pad, where the rotation is about an axis of rotation parallel with the neck, and the rotation defines a twist in the neck. One or more extension pads may also be foldable with respect to the central pad, where folding the extension pad defines a crease extending across the neck, and when folded, the extension pad overlaps the central pad. The central pad and/or the one or more extension pads may include an adhesive configured to attach the extension pad to the central pad when the extension pad is folded. In some embodiments, rotating and/or folding the extension pad occludes at least one of the at least one delivery flow path or the at least one return flow path extending along the neck.
Also disclosed herein is a method of providing a targeted temperature management (TTM) therapy to a patient. The method includes providing a thermal contact pad where the thermal contact pad includes a central pad coupled with a plurality of extension pads extending away from right and left lateral sides of the central pad. The method further includes (i) applying the central pad to a back side of the patient, (ii) applying multiple extension pads to a front side of the patient, and (iii) circulating a TTM fluid through the thermal contact pad to facilitate thermal energy exchange with the patient.
The central pad may include a fluid free zone disposed centrally along the central pad, and the method may further include preventing thermal energy exchange with the patient along a spine of the patient.
The method may further include disposing a hydrogel layer of the thermal contact pad in direct contact with a skin of the patient. The thermal contact pad may also include a hydrogel liner coupled with an underside of the hydrogel layer, and the method may further include (i) separating one portion of the hydrogel liner from another portion of the hydrogel liner, (ii) removing the one portion of the hydrogel liner from the hydrogel layer, and (iii) placing the other portion of the hydrogel liner between the hydrogel layer and the patient.
Each of the plurality of extension pads may be coupled with the central pad via a neck, and the method may further include rotating at least one extension pad to define a twist in the neck. The method may further include folding the at least one extension pad to define a crease in the neck. Each neck includes at least one delivery flow path and at least one return flow path extending along the neck, and rotating and/or folding the extension pad may occlude at least one of the at least one delivery flow path or the at least one return flow path.
The method may further include rotating and folding at least two extension pads and the at least two extension pads may include one extension pad extending laterally away from a first side of the central pad, and another extension pad extending laterally away from a second side of the central pad, where the second side is disposed opposite the first side.
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, electrical, magnetic, electromagnetic, fluid, signal, communicative (including wireless), and thermal interaction. Two components may be connected or coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to 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 includes a central pad 110. The central pad 110 may generally define a rectangular shape having beveled corners. The central pad 110 extends longitudinally from top end 107 to a bottom end 108. A plurality of extension pads 120 are coupled with and extend away from right and left lateral sides of the central pad 110. In the illustrated embodiment, the pad 100 includes ten pad extensions 120. In other embodiments, the pad 100 may include more or less than ten pad extensions 120. The extension pads 120 may also be rectangular in shape having beveled corners (e.g., having the appearance of a paddle). In other embodiments, the central pad 110 and the extension pads 120 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 central pad 110 may define a width generally sized to accommodate an average adult patient. The central pad 110 may further define a length to accommodate a larger/taller than average adult patient. A slit 112 extending along a centerline 104 upward away from the bottom end 108 of the central pad 110 facilities application of the central pad 110 separately to each leg of the patient. The central pad 110 may include indicia 109 to aide in positioning the central pad 110 on the back side of the patient. The indicia 109 may include an alignment indicium to aide in applying the central pad to the back side of the patient.
In use, a clinician may position the pad 100 on the patient so that the central pad 110 is in contact with the back side of the patient's torso from the shoulders to an upper portion of the patient's legs. The clinician may utilize the indicia 109 to align the central pad 100 with the patient's spine. The clinician may adjust the central pad longitudinally so that the slit 112 is adjacent the patient's legs. Once the central pad 110 is positioned, the clinician may wrap the extension pads 120 around the right and left sides of the patient and position the extension pads 120 on the front side of the patient's torso and legs.
A neck 115 couples each extension pad 120 with the central pad 110 as further described below. The position and dimensions of the neck 115 may be configured to accommodate application of the pad 100 to the patient, i.e., provide for an optimal fit of the pad 100 with the patient. For example, the necks 115 of extension pads 120 that are located toward the top end 107 of the central pad 110, may be longer than the necks 115 of extension pads 120 that are located toward the bottom end 108 of the central pad 110, due to the general shape and contours of the human body.
In the illustrated embodiment, each neck 115 is shown centrally located on its respective extension pad 120. In some embodiments, the neck 115 may be positioned toward a top or a bottom of its respective extension pad 120. For example, the necks 115 for extension pads 120 located adjacent the top end 107 of the central pad 110 may be positioned toward the bottom of the extension pads 120 to more comfortably extend under the arms of the patient (see
The central pad 110 includes a fluid free zone 111 extending longitudinally downward away from a top end 107 of the central pad 110 along the center line 104 of the central pad 110. The fluid containing layer 131 (see
In some instances of use, the clinician may determine that the patient is large enough to utilize the entire contract area of the pad 100. In such an instance, the clinician may remove the entire hydrogel liner 134 from the hydrogel layer 133. In other instances, the clinician may determine that the patient is too small to utilize the entire contract area of the pad 100. In such other instances, the clinician may separate one or more portions of the hydrogel liner 134 (e.g., segments 136) from a main portion of the hydrogel liner 134. The clinician may then remove the main portion of the hydrogel liner 134 from the hydrogel layer 133 leaving the separated portions in place covering the hydrogel layer 133. The clinician may then apply to the pad 100 to the patient so that the separated portions (e.g., segments 136) are disposed between the hydrogel layer 133 and the patient.
One or more of the extension pads 120 may be rotated with respect to the central pad 110 about an axis of rotation 116 defined by the neck 115, thereby causing a twist 118 in the neck 115. In
The extension pad 120 may include an adhesive 125 disposed on the underside 106. In some embodiments, the adhesive 125 may be alternately or additional disposed on the top side 105 of the central pad 110. In some embodiments, the hydrogel liner 134 may be left in place on the underside 106 of the extension pad 120B and the adhesive 125 may be disposed on the hydrogel liner 134.
The neck 115 may be configured so that when twisted, folded, or both twisted and folded, as shown in
In the second use case, the hydrogel liner segments 336A, 336B have been separated from the main portion of the hydrogel liner 134 at the perforation lines 335A, 335B, respectively. The main portion of the hydrogel liner 134 has been removed from the pad 100 leaving the hydrogel liner segments 336A, 336B attached to the pad 100. In
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 that, with the aid of the present disclosure, 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. 63/230,276, filed Aug. 6, 2021, which is incorporated by reference in its entirety into this application.
Number | Date | Country | |
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63230276 | Aug 2021 | US |