PRESSURE MANAGEMENT WARMING HEADREST

Abstract

A pressure management device with an integrated warming apparatus that provides improvements to pressure management for patients in the supine and side-laying positions, warms a patient's head during surgery; and allows for compact storage. The pressure management device includes a pressure management layer and a heating layer having a heating member that includes a heating element.

Claims

1. A pressure management warming headrest comprising: a spacer layer; a heating layer including a heating member having a heating element; and a pressure management layer comprised of at least one foam layer, wherein said spacer layer, heating layer and pressure management layer are bonded together.

2. The headrest according to claim 1, wherein the heating element is a self-regulating heating element.

3. The headrest according to claim 1, wherein the pressure management layer is comprised of first and second foam layers, said first foam layer being a high density foam layer and said second foam layer being a low density foam layer.

4. The headrest according to claim 1, wherein the heating layer forms a spiral.

5. The headrest according claim 1, wherein the heating member includes at least one substrate.

6. The headrest according to claim 1, wherein the heating layer further comprises a connector interface electrically connected to the heating element.

7. The headrest according to claim 6, wherein the connector interface includes a thermal pad having the same watt density as a heating area of the heating element.

8. The headrest according to claim 1, wherein the spacer layer is comprised of a three-dimensional spacer knit fabric.

9. The headrest according to claim 1, wherein the pressure management layer has a central opening comprised of a rectangular region and a semicircular region.

10. The headrest according to claim 1, wherein the headrest further comprises an adhesive for bonding together the space layer, the heating layer, and the pressure management layer.

11. The headrest according to claim 1, wherein the headrest further comprises a head cover attached to the pressure management layer.

12. The headrest according to claim 11, wherein the head cover is formed of an air-laid non-woven material.

13. A pressure management warming headrest system comprising: a pressure management warming headrest, including: a spacer layer, a heating layer including a heating member having a heating element, and a pressure management layer comprised of at least one foam layer, wherein said spacer layer, heating layer and pressure management layer are bonded together; and a controller for controlling operation of the pressure management warming headrest.

14. The system according to claim 13, wherein the heating element is a self-regulating heating element.

15. The system according to claim 13, wherein the pressure management layer is comprised of first and second foam layers, said first foam layer being a high density foam layer and said second foam layer being a low density foam layer.

16. The system according to claim 13, wherein the heating layer forms a spiral.

17. The system according claim 13, wherein the heating member includes at least one substrate.

18. The system according to claim 13, wherein the heating layer further comprises a connector interface electrically connected to the heating element.

19. The system according to claim 18, wherein the connector interface includes a thermal pad having the same watt density as a heating area of the heating element.

20. The system according to claim 19, wherein said system further comprises a controller cable interface for electrically connecting pressure management warming headrest to the controller.

21. The system according to claim 20, wherein the controller cable interface includes a temperature sensor for sensing the temperature of the thermal pad.

22. The system according to claim 13, wherein the spacer layer is comprised of a three-dimensional spacer knit fabric.

23. The system according to claim 13, wherein the pressure management layer has a central opening comprised of a rectangular region and a semicircular region.

24. The system according to claim 13, wherein the pressure management warming headrest further comprises an adhesive for bonding together the space layer, the heating layer, and the pressure management layer.

25. The system according to claim 13, wherein the pressure management warming headrest further comprises a head cover attached to the pressure management layer.

26. The system according to claim 25, wherein the head cover is formed of an air-laid non-woven material.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The invention may take physical form in certain parts and arrangement of parts, an embodiment of which will be described in detail in the specification and illustrated in the accompanying drawings which form a part hereof, and wherein:

[0019] FIG. 1 is a top perspective view of a pressure management warming headrest (PMWH), according to an embodiment of the present invention;

[0020] FIG. 2 is bottom perspective view of the PMWH shown in FIG. 1;

[0021] FIG. 3 shows the PMWH of FIG. 1 as part of a PMWH system according to an embodiment of the present invention;

[0022] FIG. 4 is a cross-sectional view of the PMWH, as shown in FIG. 3;

[0023] FIG. 5 is an exploded view of the PMWH shown in FIG. 1;

[0024] FIG. 6 is a top plan view of a high density (HD) foam layer of the PMWH shown in FIG. 1;

[0025] FIG. 7 is a side plan view of the high density (HD) foam layer of the PMWH shown in FIG. 1;

[0026] FIG. 8 is a top plan view of a heating layer of the PMWH shown in FIG. 1;

[0027] FIG. 9 is an enlarged view of a connector interface of the heating layer shown in FIG. 8, as coupled with a controller cable interface according to an embodiment of the present invention; and

[0028] FIG. 10 is a perspective view of the controller cable interface of the PWMH system shown in FIG. 3.

DETAILED DESCRIPTION OF THE INVENTION

[0029] Referring now to the drawings wherein the showings are for the purpose of illustrating embodiment(s) of the invention only and not for the purposes of limiting same, FIGS. 1-5 show a pressure management warming headrest (PMWH) 10 according to an embodiment of the present invention. In the illustrated embodiment, PMWH 10 is generally comprised of a high density (HD) foam layer 20, a low density (LD) foam layer 40, a heating layer 50, a spacer layer 100, and a head cover 120. It should be noted that head cover 120 is omitted from FIGS. 1, 2 and 5 for greater clarity. PMWH 10 is a component of a PMWH system 5 shown in FIG. 3.

[0030] HD foam layer 20 has a central opening 22, a lower surface 24, and an upper surface 26, as best seen in FIG. 5. In one embodiment of the present invention, HD foam layer 20 takes the form of a high density polyurethane foam, such as 2-inch thick SENL polyether polyurethane foam from William T. Burnett & Co. having a density of 2+/10% lbs/ft.sup.3 and an indentation load deflection (ILD) of 26 lbs/50 in.sup.2 to 35 lbs/50 in.sup.2. According to the illustrated embodiment, rear corners 30 of HD foam layer 20 are curved to accommodate head cover 120, described below. For example, rear corners 30 may be a curved surface defined by a radius of 63.5 mm.

[0031] Referring now to FIGS. 6 and 7, exemplary dimensions for an illustrated embodiment of HD foam layer 20 will be discussed. In the illustrated embodiment, opening 22 is comprised of a substantially rectangular region 34 and a semi-circular region 36. As shown in FIG. 6, rectangular region 34 is defined, in part, by a pair of curved surfaces 38. For example, curved surfaces 38 may be defined by a radius of 19.1 mm. Exemplary dimensions for the illustrated embodiment are as follows: [0032] D1=101.6 mm [0033] D2=50.8 mm [0034] R1 (radius)=50.8 mm [0035] L (length)=279.4 mm [0036] W (width)=317.5 mm [0037] T (thickness)=50.8 mm

[0038] The dimensions for opening 22 are preferably selected to facilitate superior pressure management for patients oriented on PMWH 10 in both supine and side-laying positions.

[0039] LD foam layer 40, according to an embodiment of the present invention, has a central opening 42, a lower surface 44, and an upper surface 46. In one embodiment of the present invention, LD foam layer 40 takes the form of a low density polyurethane foam, such as Flexible Foam Products (#10030) 1-inch thick 100% open cell polyurethane foam having a density of 0.9-1 lbs/ft.sup.3 and an indentation load deflection (ILD) of 25 lbs/50 in.sup.2 to 35 lbs/50 in.sup.2. In the illustrated embodiment, LD foam layer 40 has substantially the same shape and dimensions as HD foam layer 20, except thickness T is reduced.

[0040] HD foam layer 20 and LD foam layer 40, in combination, provide a pressure management layer for PMWH 10. In accordance with contemplated alternative embodiments of the present invention, the pressure management layer may be comprised of one or more foam layers.

[0041] Heating layer 50 is generally comprised of a flexible heating member 60 and a connector interface 70, as best seen in FIGS. 1 and 5. According to an embodiment of the present invention, flexible heating member 60 is comprised of a heating element in the form of a conductive material that is applied to a flexible substrate (e.g., polyester (PET), polyimide (PI), polycarbonate (PC), and thermoplastic polyurethanes (TPU)). The flexible substrate provides support for the heating element and serves as a dielectric. In one embodiment of the present invention, the heating element is sandwiched between a pair of the flexible substrates. The heating element may be applied to the flexible substrate by a screen printing process or other well-known fluid deposition processes, such as gravure/flexographic, ink jet, controlled spray, and the like. In the illustrated embodiment, the flexible substrate is a PET substrate having a thickness in the range of 0.003 inch to 0.010 inch.

[0042] In accordance with one embodiment of the present invention, the heating element takes the form of a positive temperature coefficient (PTC) material (e.g., a PTC heating film or PTC thermistor). A PTC heating element is typically made with a thermoplastic PTC carbon ink. A PTC heating element is a self-regulating heating element because as the PTC heating element warms up, its resistance increases (i.e., conductivity decreases), thereby reducing power. Accordingly, a PTC heating element is capable of regulating its temperature without any outside controls. The PTC heating element is preferably configured with a watt density (watts/area) such that the size of the heating element provides a thermal flux that matches the heat loss of a patient.

[0043] In one exemplary embodiment of the present invention, heating member 60 is comprised of a heating element applied to a PET substrate (e.g., having a thickness of 0.003 inch). The heating element takes the form of a layer of conductive particles. The conductive particles may be applied to the substrate by processes such as screen printing, gravure/flexographic, ink jet, controlled spray, and the like. The conductive particles can take several forms, including, but not limited to, carbon ink (e.g., Engineered Conductive Materials CI-2002 Series), carbon nanotube, graphite, and a carbon-based PTC resistor paste (PTC ink), such as DuPont 7292 PTC Carbon Resister. It should be appreciated that use of a PTC ink provides a safety benefit by allowing PMWH 10 to have a resistance magnification effect at 45 C. which is the desired heating temperature for spacer layer 100 to achieve a desired 39 C. patient surface contact temperature. Furthermore, carbon is a desirable material since it allows for radiolucency.

[0044] In one embodiment of the present invention, heating member 60 also includes a silver bus bar of interdigitated fingers to bring current to the PTC carbon resistor ink that serves as the heating element. The silver bus bar is formed on the substrate by screen printing.

[0045] After the process of applying the PTC ink is completed, heating member 60 is silkscreened for labelling, and die-cut using a steel-ruled die (or alternatively a laser, a water jet, or the like) to form a spiral 66 for pressure management, as best seen in FIG. 8. Spiral 66 has a corresponding gap 68 (e.g., approximately 2 mm). The die cutting also forms a circular center disk 62 having a slit 64 (e.g., 1 inch) for additional pressure management. Slit 64 preferably extends along the direction of the electron path, as shown in FIG. 8. However, slit 64 may be oriented orthogonal to the electron path with perforations in the heating element to control undesirable electron flow. It should be appreciated that die-cutting heating member 60 in the manner described above allows the other layers of PMWH 10 to move, thereby reducing pressure on the patient's tissues.

[0046] In accordance with an alternative embodiment of the present invention, it is contemplated that slit 64 may be replaced with a hole, thereby making center disk 62 ring-shaped.

[0047] As illustrated, the spiral configuration preferably has a double start helix so that positive and negative terminal connections can be provided at a peripheral outer exposed end of heating member 60 for easier connection with a controller. This configuration also eliminates the need to locate copper connecting wires within an X-ray zone.

[0048] To be a low heat transfer device in accordance with ISA Standard IEC80601-2-35, it is desirable to have a heating element density (Watts/area) that is less than 115 W/m.sup.2. In the illustrated embodiment, the total heating area of heating element is 0.055 m.sup.2. Therefore, wattage is 6.325 W for this embodiment of the present invention. The wattage of heating member 60 according to an embodiment of the present invention may be in the range of about 5 W to 45 W.

[0049] While heating member 60 has been described herein with respect to a PTC heating element, it is contemplated that other types of heating elements, including those that are not self-regulating may be implemented in connection with the present invention. Furthermore, it is contemplated that according to alternative embodiments of the present invention heating member 60 may be die-cut into forms other than the illustrated spiral shape.

[0050] Connector interface 70 of heating layer 50 will now be described with particular reference to FIGS. 8 and 9. Connector interface 70 is comprised of a conductive layer (e.g., silver) sandwiched between two flexible substrates. The conductive layer is electrically connected with the heating element of heating member 60. The substrates may be formed of the same material as the substrates described above in connection with heating member 60 (e.g., PET).

[0051] Holes (e.g., 2 mm) are formed in the substrates and conductive layer to receive positive and negative terminals 72, 74. In an illustrated embodiment of the present invention, positive and negative terminals 72, 74 take the form of studs or snaps that are crimped onto the holes. It is contemplated that terminals 72, 74 may take other forms, including, alligator clips or CrimpFlex contacts that are crimped through the PET substrate into the conductive inks forming the conductive layer.

[0052] Connector interface also includes an alignment hole 78 (e.g., 5 mm) and a thermal pad 80 which serves as a proxy for the temperature of the heating element of heating member 60. In one embodiment of the present invention, thermal pad 80 takes the form of screen printed carbon and silver sandwiched by dielectric substrates. To serve as the proxy for the temperature of the heating element, the area of thermal pad 80 is selected to have substantially the same thermal wattage density as the heating area of the heating element. Therefore, a costly temperature sensor does not need to be an integral component of PMWH 10, thereby making PMWH 10 less costly to implement as a disposable article. In an illustrated embodiment, thermal pad 80 is a square having side dimensions of 5-6 mm.

[0053] Spacer layer 100, functioning as a comfort layer, includes a lower surface 104 and an upper surface 106. According to an embodiment of the present invention, spacer layer 100 is formed of a spacer fabric, such as Muller Textil GmbH 3Mesh three-dimensional spacer knit fabric T6010-1000 or 3Mesh three-dimensional spacer knit fabric T5975-1000. The spacer fabric provides pressure immersion and comfort to the touch. In one embodiment of the invention, spacer layer 100 has a thickness of approximately 10 mm, but can be increased to allow for better pressure management. While an increased layer thickness increases thermal resistance, this can be accommodated by increasing the power to heating member 60 to allow for the same resultant patient contact temperature. 3Mesh spacer fabric has a substantially consistent temperature with a drop of (0.25 C) for both the compressed and uncompressed state. In the illustrated embodiment, spacer layer 100 has substantially the same shape and dimensions as HD foam layer 20, except thickness T is reduced and a central opening is omitted.

[0054] It should be understood that HD foam layer 20, LD foam layer 40, heating layer 50 and spacer layer 100 are bonded to each other by use an adhesive, such as SIMALFA water-based adhesive, 3M Super77 multipurpose spray adhesive, or Claire Mist Adhesive. Accordingly, thin layers of adhesive (not shown) are located between these layers. It should be appreciated that the adhesive may be applied to all or only portions of the layer surfaces.

[0055] Head cover 120 will now be described with reference to FIGS. 3 and 4. In the illustrated embodiment, head cover 120 is made of a lightweight, non-woven material such as an air-laid non-woven material. Air-laid non-woven materials are preferable since they are more thermally resistive than carded non-woven materials. A 5 mil air-laid polyolefin fabric provides a thermal resistance of approximately 0.32 R ([M.sup.2K]/W) which optimizes the insulation value based on the maximum desired thickness of the non-woven material. Head cover 120 is stretched over a patient's head to capture and trap convective warming heat. Other suitable materials for head cover 120 include olefin and polypropylene.

[0056] In one embodiment of the present invention, the flat pattern unsewn shape of head cover 120 is circular with a diameter of 36 inches. Head cover 120 includes an elastic gather 130 stitched into the round edge to keep it gathered around a patient's face. Elastic gather 130 is lightly stretched during the sewing process for a finished size of 5 to 6 inches diameter when relaxed. The inner surface of head cover 120 is attached to lower surface 24 of HD foam layer 20 using an adhesive 15, as illustrated in FIG. 4. The adhesive may be the same as the adhesive used for bonding together HD foam layer 20, LD foam layer 40, heating layer 50, and spacer layer 100.

[0057] It is contemplated in accordance with an alternative embodiment of the present invention that elastic gather 130 may be replaced or supplemented with a repositionable, biocompatible adhesive bonded onto a plastic film. The adhesive allows the head cover to stick to a region surrounding the patient's face.

[0058] Head cover 120 includes a hole 126 and a slit 128. Hole 126 aligns with the central opening 22 of HD foam layer 20. This allows the head cover 120 to be stuffed into central opening 22 for packaging and shipping. Since PMWH 10 is typically placed on a foam table pad for usage there is negligible heat loss through hole 126. Slit 128 provides an opening that allows connector interface 70 to pass through head cover 120 for connection with controller cable interface 170.

[0059] PMWH 10 may be compressed for compact storage by vacuum packing. In this regard, air may be removed from the foam layers to reduce volume.

[0060] Controller 160 is a conventional processing device programmed to control operation of PMWH 10. In one embodiment of the present invention, controller 160 may take the form of a control unit running an open loop at 36V designed to a self-regulating 39 C. max, at an ambient temperature of 22 C. Accordingly, the voltage delivered to the heating element is 36V with a desired temperature up to 39 C. An open loop controller may drive a PTC ink heating element with a corresponding pulse width modulation (PWM) duty cycle to obtain a desired operating temperature, as selected at controller 160 (e.g., 35 C., 36 C., 37 C. 38 C., or 39 C.). For example, a 20% PWM duty cycle may achieve a temperature of 35 C., while a 90% PWM duty cycle may achieve a temperature of 39 C. It is also contemplated that temperature sensor 180 of controller cable interface 170 could be used to drive the heating element in a closed loop fashion.

[0061] Controller 160 includes a connecting cable having a controller cable interface 170, as shown in FIG. 10. Controller cable interface 170 includes an insulated housing 171 having a recess dimensioned to receive connector interface 70 of heating layer 50. Controller cable interface 170 also includes positive and negative contacts 172, 174, alignment pin 178, and a temperature sensor 180. Positive and negative contacts 172, 174 respectively engage with positive and negative terminals 72, 74 of connector interface 70. Alignment pin 178 is dimensioned to be received in alignment hole 78 to align and secure connector interface 70 to controller cable interface 170. Temperature sensor 180 is aligned with thermal pad 80 to sense the temperature of thermal pad 80 in order to determine the temperature of heating member 60. For example, temperature sensor 180 may take the form of a thermocouple, a thermistor, or a resistance temperature detector (RTD). Temperature sensor 180 functions as a safety backup for the self-regulating heating element of heating member 60. Accordingly, temperature sensor 180 ensures that a maximum allowable temperature is not exceeded. While controller 160 is shown herein as an external device to PMWH 10, it is also contemplated that controller 160 may be integrated into PMWH 10 to form a non-disposable PMWH 10.

[0062] It should be appreciated that PMWH 10 as shown and described herein is disclosed solely for the purpose of illustrating an embodiment of the present invention and not for limiting same. It is contemplated that alternative configurations, shapes, dimensions, and materials may be substituted for those disclosed herein without departing from the present invention. For example, alternative materials for the foam layers include, but are not limited to, elastic foam, viscoelastic foam, gel, air cells, gel, viscous fluid, water, and wool. Examples of alternative shapes include, but are not limited to, donut-shaped, U-shaped, stepped conformal, and T-shaped. Dimensions of the present invention may be adapted to accommodate bariatric, adult, pediatric, and neonatal patients. Furthermore, it is contemplated that PMWH 10 may be adapted to support portions of a patient's body other than the head.

[0063] Other modifications and alterations will occur to others upon their reading and understanding of the specification. It is intended that all such modifications and alterations be included insofar as they come within the scope of the invention as claimed or the equivalents thereof.