Classifications

• • A—HUMAN NECESSITIES
  • A42—HEADWEAR
  • A42B—HATS; HEAD COVERINGS
  • A42B1/00—Hats; Caps; Hoods
  • A42B1/017—Hats; Caps; Hoods specially adapted for promoting health, e.g. with means for pressing on acupuncture points
• • A—HUMAN NECESSITIES
  • A42—HEADWEAR
  • A42B—HATS; HEAD COVERINGS
  • A42B1/00—Hats; Caps; Hoods
  • A42B1/04—Soft caps; Hoods
  • A42B1/041—Peakless soft head coverings, e.g. turbans or berets
• • A—HUMAN NECESSITIES
  • A42—HEADWEAR
  • A42B—HATS; HEAD COVERINGS
  • A42B1/00—Hats; Caps; Hoods
  • A42B1/24—Hats; Caps; Hoods with means for attaching articles thereto, e.g. memorandum tablets or mirrors
  • A42B1/245—Means for mounting audio or communication systems
• • A—HUMAN NECESSITIES
  • A42—HEADWEAR
  • A42C—MANUFACTURING OR TRIMMING HEAD COVERINGS, e.g. HATS
  • A42C5/00—Fittings or trimmings for hats, e.g. hat-bands
  • A42C5/04—Ventilating arrangements for head coverings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
  • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/6802—Sensor mounted on worn items
  • A61B5/6803—Head-worn items, e.g. helmets, masks, headphones or goggles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/6813—Specially adapted to be attached to a specific body part
  • A61B5/6814—Head
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/683—Means for maintaining contact with the body
  • A61B5/6831—Straps, bands or harnesses
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays

Definitions

• 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.
• hypothermia 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.
• 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.
• biometric sensors 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.
• the present surgical cap is constructed to minimize exposures to fibrous materials and, as such, to remove any habitat for bacterial growth.
• the present surgical cap includes an insulative inner portion and a shell fabricated from the materials sold under the trademarks
• 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. .
• 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.
• the cap can be in informational communication with various other monitoring sensors placed about the patient for acquisition of standard body sign parameters.
• any number of standard body sign parameters may be acquired, such as ECG, heart rate, breathing, oxygen saturation (Sp02), temperature, or the like.
• advanced measurements may additionally be integrated merely with the inclusion of appropriate biometric sensors and analyzers.
• 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.
• 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;
• ECG electrocardiogram
• RR respiratory rate
• RR 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).
• the present invention may similarly be used for nonsurgical patients with temperature regulatory issues, such as immunocompromised individuals, patients undergoing dialysis, and cancer patients.
• FIG. 1 is a perspective view of a Surgical Cap to Control Patient Body Temperature according to a preferred embodiment of the present invention
• FIG. 2 is a side elevational view thereof
• FIG. 3 is a front elevational view thereof
• FIG. 4 is a rear elevational view thereof
• FIG.5 is a reverse perspective showing the inner portion thereof
• FIG. 6 is a partial cross sectional view taken along lines VI-VI of FIG. 4;
• 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,
• FIG. 8 is a perspective view of a surgical cap to control patient body temperature according to an alternate embodiment of the present invention
• 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;
• 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
• 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
• 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
• a covering unit 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• the shell component comprise insulative properties.
• the shell component may further include an insulative filling.
• 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.
• 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
• 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 1 ⁇ 2 inch and most preferably less than 1/4 inch.
• 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.
• 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.
• the surgical cap 10 may comprise the various standard sizes for different age ranges.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• a medical sensor and covering unit combination 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.
• a functional electronics package in the form of a sensor patch may be incorporated within the cap 10
• 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
• 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.
• 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.
• 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.
• 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.
• 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).
• the display 20 may further be formed a graphical interface for providing direct readout of various body sign through viewing a navigation display.
• 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.
• 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.
• 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.
• 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.
• 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 1 ⁇ 2 inch and most preferably less than 1/4 inch.
• 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.
• 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.
• the surgical cap 10 may comprise the various standard sizes for different age ranges.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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);
• PPG photoplethysmography
• BG blood glucose
• SpCO carbon monoxide level
• BP blood pressure
• HL hydration levels

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Medical Informatics (AREA)
• Veterinary Medicine (AREA)
• Surgery (AREA)
• Physics & Mathematics (AREA)
• Molecular Biology (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Cardiology (AREA)
• Physiology (AREA)
• Pain & Pain Management (AREA)
• Epidemiology (AREA)
• Pulmonology (AREA)
• Measuring And Recording Apparatus For Diagnosis (AREA)
• Control Of Temperature (AREA)
• Thermotherapy And Cooling Therapy Devices (AREA)
• Professional, Industrial, Or Sporting Protective Garments (AREA)
• Accommodation For Nursing Or Treatment Tables (AREA)
• Measuring Temperature Or Quantity Of Heat (AREA)

Priority Applications (13)

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Cited By (2)

Citations (6)

Family Cites Families (14)

• 2019
  • 2019-01-18 EP EP19909630.6A patent/EP3911195A4/en active Pending
  • 2019-01-18 JP JP2021541575A patent/JP7356741B2/ja active Active
  • 2019-01-18 CA CA3127024A patent/CA3127024A1/en active Pending
  • 2019-01-18 PE PE2021001162A patent/PE20211932A1/es unknown
  • 2019-01-18 AU AU2019423256A patent/AU2019423256A1/en active Pending
  • 2019-01-18 SG SG11202106792VA patent/SG11202106792VA/en unknown
  • 2019-01-18 CN CN201980089220.7A patent/CN113645867A/zh active Pending
  • 2019-01-18 MX MX2021008541A patent/MX2021008541A/es unknown
  • 2019-01-18 KR KR1020217024244A patent/KR20210114007A/ko unknown
  • 2019-01-18 WO PCT/US2019/014368 patent/WO2020149861A1/en active Application Filing
  • 2019-01-18 BR BR112021014050-6A patent/BR112021014050A2/pt unknown
• 2021
  • 2021-07-13 EC ECSENADI202151881A patent/ECSP21051881A/es unknown
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