This disclosure generally relates to systems and methods for surgical patient warming.
Heated mattresses and heated mattress overlays for therapeutic patient warming are generally well known. Therapeutic patient warming may be useful for patients during surgery. It is well known that without therapeutic intra-operative warming, anesthetized surgical patients may become clinically hypothermic during surgery. Hypothermia has been linked to increased wound infections, increased blood loss, increased cardiac morbidity, prolonged ICU time, prolonged hospital stays, increased cost of surgery and increased death rates.
Heated water mattresses for use during surgery have been available for decades. The warm water mattresses are typically relatively stiff and inflexible. The patient may not sink into the mattress, therefore effectively touching the mattress only across their shoulders, buttocks and the back of their legs. The smaller body surface area in contact with the mattress may result in two problems. First, the smaller surface area supports the entire weight of the patient. As a result, the combination of pressure applied to the boney prominences and the heat from the warm water mattress may both reduce blood flow and accelerate metabolism, causing accelerated ischemic pressure injuries to the skin (“bed sores”). Second, the effectiveness of conductive heat transfer is proportional to the surface area in contact with the heat. A smaller area in contact with the heated water mattress can make the mattress ineffective for patient warming during surgery.
Electrically heated pads and blankets for the consumer market have been made with resistive wire heaters. In use, wire-based heaters have questionable safety. In the operating room environment with anesthetized patients, hot spots caused by the wires in normal use and the failure mode of broken heater wires resulting in sparking, arcing and fires may prevent their use in operating rooms.
Sheet-like, flexible electrical resistance heaters have been shown to be more effective in warming the patients because of the even heat production and generally do not cause arcing and sparking when they fail. The sheet-like electric heaters may be made of conductive or semi-conductive cloth, film or ink. An example of these mattresses is disclosed in U.S. patent application Ser. No. 13/422,279, Heated Under-body Warming Systems, which is hereby incorporated by reference in its entirety. The electrically heated mattresses generally have one or more layers of compressible foam with an overlaying heater layer. Additionally, they may have another layer of foam or fibrous material overlaying the heater. Finally the whole mattress may be enclosed in a waterproof shell.
Such electric mattresses are much more compressible and accommodating than the hard vinyl water mattresses. Further, unlike the water mattresses, the electric heaters do not harden or stiffen over time. Because the electrically heated mattresses are more compressible and accommodating, the patients sink into the mattress and thus more body surface area is recruited to help support the weight of the patient. If the proper foam materials are chosen, virtually the entire posterior surface of the patient can contact the mattress. In comparison to the old water mattresses, the added body surface contact area reduces the pressure applied to the pressure points and simultaneously increases the surface area available for heat transfer. However, even with the added contact surface area, these mattresses may be incapable of transferring enough heat to maintain patient normothermia, especially in pediatric patients.
The limitation in heat transfer is related to the fact that even though the entire anterior or posterior surface of the patient may be in contact, the surface geometry of the mattress may prevent mattress contact with the surface areas of the patient's sides. As the patient sinks into the foam mattress, the upper layer of the protective shell material and the heater layer can create an indentation with gradually tapered sides. Steeply tapered sides would be preferable for conductive thermal contact. It may be physically impossible for a foam mattress with a plastic film cover to closely conform to a patient's shape. The foam and overlying heater layer adjacent the side of the patient may taper away from the patient. Thus, even though the patient may have sunken into the foam, only a small additional surface area long their posterior sides may be in thermal contact.
Another concern with foam mattresses involves their use with pediatric patients. The light weight of the pediatric patient (e.g., in comparison to an adult) may prevent them from sinking into the foam mattress. Therefore, forming the foam around the patient's body thereby increasing the contact with their side surfaces may be challenging to achieve in the case of pediatric patients.
Surgical patient warming mattresses with a greater heat transfer capacity are needed.
Certain embodiments of the invention include a conformable heated mattress for therapeutic under-body warming during surgery. The mattress may include a heated layer with an electrical heating element, and a base layer coupled to the operating table. The electrical heating element may have elastic properties. The heated layer may have a first sheet of a shell, and a second sheet of the shell. The first and second sheets may be bonded together around their peripheries to form a substantially liquid-proof enclosure, wherein the electrical heating element is sandwiched between the first and second sheets. The heated layer can be coupled to an opposing surface of the base layer at a portion of the opposing surface forming an attached area. The attached area may be less than an area of the opposing surface allowing at least a portion of the heated layer to be folded substantially independently of the base layer.
Certain embodiments of the invention include a method of positioning a patient on a heated mattress. The method may include the step of providing a conformable heated mattress according to certain embodiments of the invention. The base layer may then be positioned on an operating table. The patient may be positioned on top of the heated layer. One or more portions of the heated layer may be folded upwards and lateral to the sides of the patient. A positioning roll may then be placed between the heated layer and the base layer to hold the heated layer proximate the sides of the patient.
The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
The following drawings are illustrative of particular embodiments of the present invention and therefore do not limit the scope of the invention. The drawings are not necessarily to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Embodiments of the invention will hereinafter be described in conjunction with the appended drawings, wherein like numerals denote like elements.
The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides some practical illustrations for implementing exemplary embodiments of the present invention. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements, and all other elements employ that which is known to those of ordinary skill in the field of the invention. Those skilled in the art will recognize that many of the noted examples have a variety of suitable alternatives.
Embodiments of the invention include a conformable heated mattress for therapeutic under-body warming during surgery. Such embodiments may also be used in heated blankets and similar body warming systems typically used for medical applications (e.g., in surgery). For instance, certain embodiments of the invention can be incorporated into the heated mattress inventions disclosed in U.S. patent application Ser. No. 13/422,279. Embodiments of the invention described herein may be described in U.S. Pat. No. 7,714,255, Bus Bar Attachments for Flexible Heating Elements, U.S. patent application Ser. No. 13/422,279, Heated Under-body Warming Systems, U.S. Pat. No. 8,283,602, Heating Blanket, the disclosures of each of which is hereby incorporated by reference in its entirety. The heated mattress according to certain embodiments facilitates improving heat transfer between the patient and the mattress by increasing the surface area of contact between the mattress and the patient's body. Certain embodiments may increase the surface area of contact by substantially separating the patient support functions of the mattress from the patient warming functions of the mattress. By separating these two functions, each function, i.e., support for the patient and patient warming, can be simultaneously provided and maximized independently. Such embodiments provide a safe and effective heated support surface for surgery.
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The electrical heating element 34 may have elastic properties (e.g., be stretchable). The electrical heating element 34 can be coupled to the heated layer 30 around at least a portion of its periphery. The electrical heating element 34 may include a fabric coated with an electrically semi-conductive material. In some embodiments, the conductive or semi-conductive coating may be a polymer and the bonding process is polymerization. The coating on each individual thread of polymer may allow maximal flexibility and may not crack, fracture or delaminate during flexion. Polymerization of these conductive or semi-conductive materials on individual fibers of the carrier fabric can be an optimal process for producing a durable, flexible and stretchable heater. In some embodiments, the electrically semi-conductive material is polypyrrole. Alternatively, the electrical heating element 34 includes one or more of conductive fabrics and films. The conductive fabrics can be at least one of carbon fiber, carbonized fibers, woven substrates coated with semi-conductive or conductive coating, non-woven substrates coated with conductive or semi-conductive coating, carbonized ink, metalized ink and/or carbon impregnated plastic films. However, other coatings are also anticipated and conductive coatings that use carbon or metal as the conductive material are also anticipated. Such coatings may provide an electrically semi-conductive fabric heater that may be highly flexible, durable, may have elastic properties and may not fracture either the carrier fiber or the semi-conductive polymer coating with repeated flexing, loading and stretching. Additionally, the heater fabric may not require lamination for mechanical stabilization.
The electrical heating element 34 which may be a coated fabric may be further coated with a thin layer of elastomeric material such as silicone rubber. Other elastomers are also anticipated. Elastomers may offer a liquid-proof coating and prevent liquid ingressing into the fabric. The purpose of coating one or both sides of the heater element with an elastomer may be to protect the heater fabric from damage by liquids and oxidation. The coating of silicone rubber may also provide electrical insulation in the event that adjacent areas of heater surface contact one another, shorting the electrical pathway. Very thin layers of silicone rubber (e.g., thinner than the fabric of the heating element) will suffice and add minimal stiffness to the construction. Alternately, thermoplastic elastomers or plastic films may be applied to one or both sides of the heater material.
According to some exemplary embodiments, the conductive fabric of the electrical heating element 34 may include a woven polyester sheet being coated with polypyrrole. The coated fabric may have an average electrical resistance, of approximately 15-30 ohms per square at about 48 volts, as determined with an exemplary four point probe resistance measurement method. Such fabrics may provide a desirable heat generation which may be quantified by the fabric's watt density, or, the rate of heat generated per unit surface area of the fabric. In some embodiments, the heating element 34 may provide a substantially uniform watt density output across the surface of the fabric. For instance, the watt density output of the heating element 34 can be less than approximately 0.5 watts/sq. inch. Alternatively, the watt density output of the heating element 34 can be between approximately 0.2 and approximately 0.4 watts/sq. inch, across a surface area. The surface area may include and extend between lateral edges of the heating element 34. The electrical resistance of the conductive fabric may be suitable to produce a watt density of between approximately 0.2 watts/sq. in and approximately 0.4 watts/sq. in. when a width of the fabric is approximately 16-28 inches. Such a width may be suitable for a mattress 10 heating assembly, some embodiments of which will be described below.
In some exemplary embodiments, the electrical heating element 34 may have variable electrical resistance. As the electrical resistance is related to the heat generated by the fabric as described previously, variability in resistance thus translates to variability in heat generated by the heating element 34. For instance, the electrical resistance of the heating element 34 (e.g., a conductive fabric) may be tailored based on the geometry of the electrical heating element 34 (e.g., width of the fabric between electrical connections). An exemplary embodiment may have the width of the conductive fabric of the electrical heating element 34 varying inversely with electrical resistance. Other examples may include varying the electrical resistance by increasing or decreasing a surface area of the fabric that can receive the conductive coating, or, by increasing or decreasing the basis weight of the fabric. Alternatively, or in addition, the resistance of such conductive fabrics may vary over surface areas, for example, due to variation in a thickness of a conductive coating, variation within the conductive coating itself, variation in effective surface area of the substrate which is available to receive the conductive coating, or variation in the density of the substrate itself. In such embodiments, precise temperature control may be provided, particularly if the mattress 10 is used for patient warming during surgery.
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The conductive fabric of the heating element 34 can be anchored around its periphery to the shell and thus held in an extended and wrinkle-free condition. In this embodiment, strips of plastic film may be coupled to the edges of the fabric by sewing. The strips may extend laterally and may also extend longitudinally beyond the ends of the fabric. The strips of plastic film may be made of the same material as the shell and therefore can be bonded around the periphery of the mattress 10, into the bond between the first sheet of the shell and second sheet of shell.
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In some embodiments, the layer(s) of foam 24 of the base layer 20 and the heating element 34 may both be covered by one or more sheets 54, 56 of a shell. While any polymer of appropriate thickness such as 10-30 mils can be suitable for use with the shell, some exemplary polymers include polyurethane and/or PVC. Such polymers retain strength and flexibility during routine use. Other polymers (e.g. Naugahyde) such as a polymeric film extruded onto a woven fabric may also be used. The sheets can be bonded to each other and/or to the heating element 34 by any means known in the art. Some exemplary means include by heat, radio frequency (RF), ultrasound welding, bonding via a solvent and/or an adhesive or by sewing with thread. For instance, the first and second sheets 46, 48 can be bonded together at periphery 50 to form a substantially liquid-proof enclosure (e.g., a hermetically-sealed pouch) in which the electrical heating element 34 can be sandwiched. Likewise, a third sheet 54 of the shell and a fourth sheet 56 of the shell may be bonded together around their peripheries 60 to form a substantially liquid-proof enclosure (e.g., a hermetically-sealed pouch) around base layer 20. One or more layers of foam forming the base layer 20 may be sandwiched between the third and fourth sheets 54, 56 of the shell. This arrangement may prevent any damage to the heated and base layers 30, 20 due to liquids (e.g., bodily fluids released by a patient during surgery).
Embodiments of the invention also include a method of positioning a patient on the mattress. The method may involve the step of providing a mattress according to certain embodiments disclosed herein. The base layer of the mattress may be connected to the operating table. Any known connection means between the base layer and the operating table are contemplated. The patient may be positioned on top of the heated layer, substantially in a central region or on the midline of the mattress. Reference is now made to
In some embodiments, patient-positioning rolls may be placed under the heated layer to maintain maximal heat transfer characteristics while allowing complex patient positioning. For example, small rolls of towels are frequently placed under the chest/shoulder blades of pediatric patients in order to put their back into extension and improve access to their upper abdomen. If this positioning roll is placed above the standard heated mattress, the roll lifts half of the patient's body off of the heated surface. Naturally this may reduce the heat transfer between the mattress and the patient. In contrast, various embodiments allow the positioning roll to be placed under the heated layer and the heating element may thus stay in conductive thermal contact with an entire anterior or posterior surface of the patient.
Such embodiments may offer one or more benefits. By substantially separating the heating function from the support function, various embodiments may allow the heated layer to maximally contact the non-weight-bearing side surfaces of the patient for enhanced heat transfer, especially for the pediatric patients. Certain embodiments may allow the body surface area in contact with the heated surface to approximately double in comparison to known heated mattresses. Various embodiments may significantly increase the heat transfer effectiveness of the mattress, especially in pediatric patients, while maintaining improved safety with regards to patient positioning, folding or bunching of the heater under the patient. By separating the heater layer from the base layer, the better support and enhanced heat transfer may both be accomplished during surgery.
Thus, embodiments of the invention are disclosed. Although the present invention has been described in considerable detail with reference to certain disclosed embodiments, the disclosed embodiments are presented for purposes of illustration and not limitation and other embodiments of the invention are possible. One skilled in the art will appreciate that various changes, adaptations, and modifications may be made without departing from the spirit of the invention.
This application claims priority to U.S. Provisional Application Number 61/812,987, Flexible Electric Heaters, filed on Apr. 17, 2013, the disclosure of which is hereby incorporated by reference in the entirety.
Number | Date | Country | |
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61812987 | Apr 2013 | US |