PATIENT BODY TEMPERATURE

BACKGROUND OF THE INVENTION

1. Field of the Invention

[0001] The present invention relates generally to a device and a method that maintains a patient’s body temperature during surgical procedures and, more specifically, to a surgical, insulative cap that both aids in maintaining the patient’s core body temperature at an euthermic range and further incorporates a graphic display panel for providing a remote caregiver informational interface.

2. Description of the Related Art

[0002] The vast majority of patients that undergo anesthetic experience some level of hypothermia. The decrease in temperature is variable, but it worsens in the procedures that involve larger and lengthier surgical exposures. The state of relative hypothermia can significantly and adversely affect a patient, especially during the perioperative and the postoperative periods. Complications related to hypothermia include myocardia ischemia, hypertension, tachycardia, and the infections that lead to unanticipated mortality and morbidity. Because most of a patient’s heat capacity is lost through an uncovered head, the medical industry is combating the problem by developing a means to keep the patient euthermic.

[0003] The present invention teaches a surgical, insulative cap that is designed both to contour a patient’s head and ears and to m aintain its position during surgery in combination with an interface for displaying the output of biometric sensors that can provide continuous, accurate standard vital body sign parameters such as body temperature, but can also include sensors for other biometric data such as body temperature heart rhythm, heart rate, breathing activity, Sp02, etc. sufficient to detect malignant hyperthermia or hypothermia as well as other deleterious perioperative, and postoperative conditions.

SUMMARY OF THE INVENTION

[0004] It is an object of the present invention to provide a flexible and a disposable surgical cap that is worn by patients during surgical procedures. It is an object of the present invention to reduce the risks to patients, especially to the elderly patients at higher risks, for developing hypertension, tachycardia and the other conditions related to surgical hypothermia. It is an object that the present cap is comprised of an insulative material that is both stretchable and flexible to provide a means for the cap to follow the contour of a head.

[0005] It is an object that the present surgical cap is constructed to minimize exposures to fibrous materials and, as such, to remove any habitat for bacterial growth.

[0006] It is envisioned that the present surgical cap includes an insulative inner portion and a shell fabricated from the materials sold under the trademarks

THERMALITE®, THINSULATE® or OUTLAST ⁴ ®. More specifically, the cap includes a ceramic fiber material, a commercially synthetic material having fibers that contain a plurality of microencapsulated and paraffinic hydrocarbons (hereinafter a“phase change material”) and a synthetic microfiber having a composition approximating 65% olefin and 35% polyester. The cap extends over a greater portion of a patient’s forehead, over the patient’s ears and behind the head to reach as far as the top of the lumbar spine. .

According to one aspect of the invention, monitoring sensors may be integrated directly into the cap in contact with the patient’s head in order to facilitate acquisition and display of standard vital body sign parameters. According to yet another aspect of the invention, the cap can be in informational communication with various other monitoring sensors placed about the patient for acquisition of standard body sign parameters. In either aspect, any number of standard body sign parameters may be acquired, such as ECG, heart rate, breathing, oxygen saturation (Sp02), temperature, or the like. Further, advanced measurements may additionally be integrated merely with the inclusion of appropriate biometric sensors and analyzers.

[0007] It is envisioned that the present surgical cap includes a caregiver interface in the form of a display screen positioned at the front of the cap in alignment with the patient’s forehead. The present invention provides for utilization in an environment beyond the operating room. The location and operation of such an interface display screen allows doctors, nurses, EMT’s or others to easily access the information output of selected vital body sign sensors in a manner that both travels with the patient as well as eliminates the need for a caregiver to divert attention from patient care activities. [0008] It is an object of the present invention to provide a surgical, insulative cap that both aids in maintaining the patient’s core body temperature at an euthermic range and further incorporates an information display for communication with biometric sensor capacity.

[0009] It is a final object of the present invention to provide all of the advantages that the foregoing objects entail. The present invention departs from the current designs to overcome their respective disadvantages. The present invention will maintain its position during and after the repeated times an anesthesiologist

manipulates the head’s position to access monitor apparatuses.

The present invention continues to provide access to the central venous region. The present invention will provide a display for the proper position for viewing information from sensors for acquiring body sign parameters including: body temperature;

electrocardiogram (ECG); respiratory rate (RR) and End Tidal Carbon Dioxide

(ETC02); heart rate (HR); oxygen saturation (Sp02); photoplethysmography (PPG); blood glucose (BG); carbon monoxide level (SpCO); blood pressure (BP); and hydration levels (HL).

[0011] Additionally, it is envisioned that the use of physical tracking of location or position, such as through GPS or other means, may be incorporated for healthcare, military, industrial and consumer markets.

[0012] The present invention may similarly be used for nonsurgical patients with temperature regulatory issues, such as immunocompromised individuals, patients undergoing dialysis, and cancer patients.

[0013] Further features of the invention will become apparent in the course of the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The advantages and the features of the present invention will become better understood with reference to the following more detailed description and the claims taken in conjunction with the accompanying drawings, in which like elements are identified with like symbols, and in which:

[0015] FIG. 1 is a perspective view of a Surgical Cap to Control Patient Body Temperature according to a preferred embodiment of the present invention;

[0016] FIG. 2 is a side elevational view thereof;

[0017] FIG. 3 is a front elevational view thereof;

[0018] FIG. 4 is a rear elevational view thereof;

[0019] FIG.5 is a reverse perspective showing the inner portion thereof;

[0020] FIG. 6 is a partial cross sectional view taken along lines VI-VI of FIG. 4;

[0021] FIG. 7 is a perspective view of a surgical sap to control patient body temperature according to a preferred embodiment of the present invention, wherein the surgical cap is shown in cooperation with a wearer’s head; and,

[0022] FIG. 8 is a perspective view of a surgical cap to control patient body temperature according to an alternate embodiment of the present invention; [0023] FIG. 9 is a front perspective view of a Surgical Cap to Control Patient Body Temperature according to a first alternate embodiment of the present invention incorporating a securement strap;

[0024] FIG. 10 shows the display screen 20 the present invention for use as a graphical user interface for showing core body vitals of a patient in operative

communication with various monitors and lifesaving devices such as a defibrillator;

[0025] FIG. 11 shows the display screen 20 the present invention for use as a graphical user interface for showing core body vitals of a patient in operative

communication with a smart hospital bed; and

[0026] FIG. 12 shows the display screen 20 the present invention for use as a graphical user interface for showing core body vitals of a patient in operative

communication with an emergency medical transport vehicle.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] The best mode for carrying out the invention is presented in terms of its preferred embodiment, herein depicted within the Figures 1-7.

1. Detailed Description of the Figures

[0022] Referring now to FIG. 1-5, a covering unit, generally noted as 10, is shown for covering a patient's head for maintaining the head temperature and core body temperature within euthermic range during surgery. The covering unit 10 covers a substantial portion of the head 70, as will be described in greater detail below and forms a multi-part shell component having an inner surface 12 adapted for closely fitting the contours of a patient’s head so as to prevent open air space between the head and an inner surface. The shell component further has an outer surface 14, and forming an opening 16 circumscribed by a gripping lower edge 18. This gripping lower edge 18 forms a gripping means for gripping to a patient’s head in a manner such as to impede said the head covering unit from coming off of the patient’s head during surgery. The shell component preferrably will provide insulating properties, and may include an insulating filling. However, in greater detail as shown in FIG. 6, the material of the shell component is anticipated as being thicker than 1 mm and less than 2mm thick and adapted for positioning over both lateral side portions of the head. This shell is of a thickness suitable for maintaining the patient’s head temperature within euthermic range.

[0023] As additionally anticipated and shown best in conjunction with FIG. 5-6, an additional insulating component 19 lining a portion of the inner surface 12. The insulating component 19 lining the top center panel is provided having a greater thickness to cover areas adapted to cover the posterior, the anterior and the top portions of said head. The thickness may be greater than 2 mm. Further, the lateral portions of the insulating component 19a lining the first side panel and the second side panel further may have a lesser thickness at both lateral side portions of the head. This thickness may be less than 2mm.

[0024] Also illustrated in FIG. 1-7, the cap 10 will preferably cover below the mid point of the external auditory meatus bilaterally in addition to the rear portion of the head and upper neck region. The material covering the head has been designed to be in contact with the head in all covered areas so as to prevent a signification amount of air space between the head and the inner material covering the head. To accomplish this, the shell component is made from a pattern cut that is asymmetric from a section of the covering unit adapted for covering the front of the head and a section of the covering unit adapted for covering the rear of the head covering unit, such that the pattern cut has a concave pattern so as to emulate the shape of the front and rear of the head to prohibit the head covering unit from coming off of the head during surgery.

[0025] It is preferred that the shell component comprise insulative properties.

The shell component may further include an insulative filling.

[0026] It is anticipated that the material of the shell component, as shown in FIG. 6, approximates a thickness no less than 1-mm and preferably between 1-mm and 2- mm or greater. The shell’s thickness is not limited to the approximations disclosed herein, but may alternatively comprise any thickness that both maintains euthermic range and adapts to a position over both lateral portions of the patient’s head.

[0027] It is additionally anticipated that an additional insulative component 19 lines a portion of the inner surface 12, as best shown in FIGS. 5 and 6. The insulative component 19 comprises material having a thickness greater than 2-mm at the areas adapted to cover the posterior, the anterior and the top portions of the head. The insulative component 19 comprises material having a thickness less than 2-mm at the areas adapted to cover both of the lateral portions. The surgical cover 10 insulates a greater portion of the patient’s head along approximately the central third, the anterior and the posterior portions. As also illustrated in FIGS. 1-7, the surg ical cap 10

preferably covers below the midpoint of the external auditory meatus bilaterally in addition to the rear portion of the head and the upper neck region. The inner material that covers the head is designed to be in direct contact with the head to prevent the adverse effects a surgical cap having air gaps has on patient hypothermia. The direct contact is accomplished by means of a shell component made from a pattern cut asymmetrically from a section of the covering unit adapted to cover the front of the head and from a section of the covering unit adapted to cover the rear of the head. The pattern cut is concave to emulate the shape of the front and the rear of a head; it prohibits the surgical cap 10 from falling off during surgery. The pattern forms a gap less than 3/4 inch, preferably less than ½ inch and most preferably less than 1/4 inch.

[0028] It is additionally contemplated that the surgical cap 10 include material that comprises a temperature regulating microfiber. The enclosed cap may further incorporate a chin strap attached to the lower right and the lower left aspects of the surgical cover 10.

[0029] It is envisioned that the cap 10 is manufactured in various sizes, e.g., the standard sizes that include extra-small, small, medium, large, extra-large and the like. For a more efficient fit, the surgical cap 10 may comprise the various standard sizes for different age ranges. Additionally, an adjustment or a take-up mechanism may be used to ensure a close-fit over the patient’s head without pressing on the patient’s head. The surgical cap 10 laterally grips below the patient’s external auditory meatus. Finally, it is envisioned that the material used in the head covering unit does not emit sparks nor is it static conductive. It may even be made of a fire retardant material.

[0030] FIGS. 1-3 further illustrate that an embodiment of the disclosed invention can be made from a pattern cut asymmetrically from a section of the surgical cap 10 adapted to cover the front of the head and a section of the surgical cap 10 adapted to cover the rear of the head. Such a pattern is concave to emulate the shape of the front and the rear of the head and to prohibit the head covering unit from falling off during surgery. This embodiment includes a rear panel 20, a front panel 22, a top panel 24, and a medial and a lateral side panel 26 covering the mid point of the external auditory meatus bilaterally. The seams between the sides contain the external aspects to prevent the surgical cap 10 from moving when it is laid on the posterior side, the medial or lateral side of the body.

[0031] FIGS. 1-3 further illustrated that an example of the disclosed invention can be made from a pattern cut that is asymmetric from a section of the covering unit adapted for covering the front of the head and a section of the covering unit adapted for covering the rear of the head covering unit. Such a pattern cut has a concave pattern so as to emulate the shape of the front and rear of the head to prohibit the head covering unit from coming off of the head during surgery, and includes a rear panel 20, a front panel 22, a top panel 24, a medial and lateral side panel 26 covering the mid point of the external auditory meatus bilaterally. The seams between the sides containing external aspects so as to contain the head from movement when laying on the posterior side, or the medial or lateral side of the body.

[0032] Referring now to FIG. 8, a perspective view of a Surgical Cap for

Controlling Patient Body Temperature according to an alternate embodiment of the present invention that includes an additional chinstrap 80 attached to the covering unit 10 across the opening 16 and at the lower edge 18. While the chinstrap 80 is intended to provide additional protection for the prevention of maintaining said head covering on the patient’s head during surgery.

Referring now to the Figures, a medical sensor and covering unit combination, generally noted as 10, is shown for covering a patient's head for maintaining the head temperature and core body temperature within euthermic range during surgery. The covering unit 10 covers a substantial portion of a patient’s head, as will be described in greater detail below, and forms a multi-part shell component having an inner surface 12 adapted for closely fitting the contours of a patient’s head so as to prevent open air space between the head and an inner surface. The shell component further has an outer surface 14, and forming an opening 16 circumscribed by a gripping lower edge 18. This gripping lower edge 18 forms a gripping means for gripping to a patient’s head in a manner such as to impede said the head covering unit from coming off of the patient’s head during surgery. [0033] According to one aspect of the present invention, a functional electronics package in the form of a sensor patch may be incorporated within the cap 10

Referring in conjunction with FIG. 9 through FIG. 12, such an aspect may utilized a removable patch module 50 that incorporates monitoring sensors 52 accessing an inner surface in a manner taught by the Related Applications, incorporated by reference as if fully rewritten herein. According to a further aspect of the present invention

informational communication with remote sensors of an otherwise conventional or remote location affixed to a patient’s body that can communicate wirelessly to provide vital signs information. It is envisioned that the present surgical cap includes a caregiver interface in the form of a display screen 20 positioned at the front of the cap in alignment with the patient’s forehead. The location and operation of such an interface display screen allows doctors, nurses, EMT’s or others to easily access the information output of selected vital body sign sensors in a manner that both travels with the patient as well as eliminates the need for a caregiver to divert attention from patient care activities.

[0034] It should be apparent to a person having ordinary skill in the relevant art, in light of the present teachings, that alternate sensor configuration or placement may be provided, and that such modifications are and should be broadly considered within the range of equivalents of the present invention. By way of one example, and not as a limitation, monitoring sensors may be integrated directly into the inner surface 12 of the cap 10 in contact with the patient’s head in order to facilitate acquisition of standard vital body sign parameters. By way of another example, and not as a limitation, monitoring sensors may be distributed about and attached to various other parts of the patient’s body and be in communication wirelessly with the display 20 on the patient’s head in order to facilitate acquisition of standard vital body sign parameters.

[0035] In any sub-configuration, the cap 10 is intended maintain its position during and after the repeated times when medical personnel manipulates the patient’s position during medical and surgical treatments. The cap 10 will provide the proper position and contact of sensors for acquiring body sign parameters including: body temperature; electrocardiogram (ECG); respiratory rate (RR) and End Tidal Carbon Dioxide (ETC02); heart rate (HR); oxygen saturation (Sp02); photoplethysmography (PPG); blood glucose (BG); carbon monoxide level (SpCO); blood pressure (BP); and hydration levels (HL).

[0036] About the outer surface 16 and functionally positioned at the forehead region of the wearer’s head the display 20 may further be formed a graphical interface for providing direct readout of various body sign through viewing a navigation display.

[0037] While various types of body vital sign sensors are currently in use, and it would be obvious to one skilled in the relevant art, in light of the present disclosure, that the specific type of sensor should not form a limitation on the overall functions and features of the present invention. Additionally, it is envisioned that the use of physical tracking of location or position, such as through GPS or other means, may be incorporated for healthcare, military, industrial and consumer markets. [0038] The shell component 14 preferably will provide insulating properties, and may include an insulating filling. However, the material of the shell component is anticipated as being thicker than 1 mm and less than 2mm thick and adapted for positioning over both lateral side portions of the head. This shell is of a thickness suitable for maintaining the patient’s head temperature within euthermic range.

[0039] As additionally anticipated, an additional insulating component 19 lining a portion of the inner surface 12. Also illustrated throughout the Figures, the cap 10 will preferably cover below the midpoint of the external auditory meatus bilaterally in addition to the rear portion of the head and upper neck region. The material covering the head has been designed to be in contact with the head in all covered areas so as to prevent a signification amount of air space between the head and the inner material covering the head. To accomplish this, the shell component is made from a pattern cut that is asymmetric from a section of the covering unit adapted for covering the front of the head and a section of the covering unit adapted for covering the rear of the head covering unit, such that the pattern cut has a concave pattern so as to emulate the shape of the front and rear of the head to prohibit the head covering unit from coming off of the head during surgery. Additionally, a number of separate insulating panels, namely a pair of side panels 22 flanking a central panel 24. In such a construction each of the panels 22, 24 may be adjustably fitted about a wearer’s head by an adjustable stretch joint 26 positioned between the panels 22, 24 and along their intersections.

[0040] The surgical cover 10 insulates a greater portion of the patient’s head along approximately the central third, the anterior and the posterior portions. As also illustrated, the surgical cap 10 preferably covers below the midpoint of the external auditory meatus bilaterally in addition to the rear portion of the head and the upper neck region. The inner material that covers the head is designed to be in direct contact with the head to prevent the adverse effects a surgical cap having air gaps has on patient hypothermia. The direct contact is accomplished by means of a shell component made from a pattern cut asymmetrically from a section of the covering unit adapted to cover the front of the head and from a section of the covering unit adapted to cover the rear of the head. The pattern cut is concave to emulate the shape of the front and the rear of a head; it prohibits the surgical cap 10 from falling off during surgery. The pattern forms a gap less than 3/4 inch, preferably less than ½ inch and most preferably less than 1/4 inch.

[0041] It is additionally contemplated that the surgical cap 10 include material that comprises a temperature regulating microfiber. The enclosed cap may further incorporate a chin strap attached to the lower right and the lower left aspects of the surgical cover 10.

[0042] It is envisioned that the cap 10 is manufactured in various sizes, e.g., the standard sizes that include extra-small, small, medium, large, extra-large and the like. For a more efficient fit, the surgical cap 10 may comprise the various standard sizes for different age ranges. Additionally, an adjustment or a take-up mechanism may be used to ensure a close-fit over the patient’s head without pressing on the patient’s head. The surgical cap 10 laterally grips below the patient’s external auditory meatus. Finally, it is envisioned that the material used in the head covering unit does not emit sparks nor is it static conductive. It may even be made of a fire retardant material. It is envisioned that the head covering unit may include attached pouches suitable for the placement of therapeutic or service elements necessary for the functions of the cap, including pouches of heating or cooling materials; hemostatic materials to control bleeding from head wounds; batteries, and diagnostic and analytic units supporting the functions of the vital sign monitors.

[0043] FIG. 2 further illustrated that an example of the disclosed invention can be made from a pattern cut that includes a chinstrap 30 that may be provided attached to or extending from each side panel 22 across the opening 16 and at the lower edge 18. The chinstrap 30 is intended to provide additional protection for the prevention of maintaining said head covering on the patient’s head during surgery. 2. Operation of the Preferred Embodiment

[0044] In operation, the present invention the covering unit 10 is anticipated for use in maintaining the head temperature and core body temperature within euthermic range during or after surgery. The patient's head 70 is covered at the forehead, ears and a base having a back portion along a line where the head and neck meet. The covering unit 10 is closely fitted to the head 70 and maintains a close proximity throughout surgery. The head covering 10 provides further additional insulation at least a portion of a patient’s head during surgery. The cap 10 is made such as to grippingly engage below the wearer’s external auditory meatus bilaterally and conform closely to the patient's head. The display screen 20 provides a graphical user interface for showing core body vitals of a patient connected to defibrillators (FIG. 3), smart hospital beds (FIG. 4), smart ambulances (FIG. 5) or similar other medical equipment. The display screen 20 may show, but not be limited too, various vital sign parameters including: body temperature; electrocardiogram (ECG); respiratory rate (RR) and End Tidal Carbon Dioxide (ETC02); heart rate (HR); oxygen saturation (Sp02);

photoplethysmography (PPG); blood glucose (BG); carbon monoxide level (SpCO); blood pressure (BP); and hydration levels (HL). An additional inclusion of a GPS tracking or physical location positioning sensors for may be further incorporated and adapted for healthcare, military, industrial and consumer markets.

[0045] The foregoing descriptions of the specific embodiments of the present invention have been presented for the purposes of illustration and description only. They are not intended to be exhaustive nor are they intended to limit the invention to the precise forms disclosed and, obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention and its various embodiments with various modifications as are suited to the particular use

contemplated. It is intended that the scope of the invention be defined by the Claims appended hereto and their equivalents. Therefore, the scope of the invention is to be limited only by the following claims.