WO2021214349A1 - Protective device for arranging a respiratory accessory over the upper airway to provide assisted ventilation and/or intubation with a video laryngoscope - Google Patents

Protective device for arranging a respiratory accessory over the upper airway to provide assisted ventilation and/or intubation with a video laryngoscope Download PDF

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Publication number
WO2021214349A1
WO2021214349A1 PCT/ES2020/070249 ES2020070249W WO2021214349A1 WO 2021214349 A1 WO2021214349 A1 WO 2021214349A1 ES 2020070249 W ES2020070249 W ES 2020070249W WO 2021214349 A1 WO2021214349 A1 WO 2021214349A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheet
video laryngoscope
patient
respiratory
accessory
Prior art date
Application number
PCT/ES2020/070249
Other languages
Spanish (es)
French (fr)
Inventor
Luis Antonio Ruiz
Original Assignee
Prodol Meditec S.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Prodol Meditec S.A. filed Critical Prodol Meditec S.A.
Priority to PCT/ES2020/070249 priority Critical patent/WO2021214349A1/en
Publication of WO2021214349A1 publication Critical patent/WO2021214349A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00Surgical drapes
    • A61B46/10Surgical drapes specially adapted for instruments, e.g. microscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00142Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with means for preventing contamination, e.g. by using a sanitary sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147Holding or positioning arrangements
    • A61B1/00154Holding or positioning arrangements using guiding arrangements for insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00Surgical drapes
    • A61B46/20Surgical drapes specially adapted for patients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00Surgical drapes
    • A61B46/20Surgical drapes specially adapted for patients
    • A61B46/23Surgical drapes specially adapted for patients with means to retain or hold surgical implements

Definitions

  • a protection device for disposition of a respiratory accessory over the upper airway to provide assisted ventilation and / or intubation with a video laryngoscope is used for processes that require, by the medical professional, contact with the upper airway of a patient, for example, to provide assisted ventilation, by placing a ventilation mask on the patient, or to intubate with a video laryngoscope, that is, to arrange on the patient a respiratory accessory used to facilitate the patient's breathing.
  • the device comprises a sheet and is intended to provide a physical barrier to protect the medical professional, or person who handles and arranges the respiratory accessory on the patient, which for example can be a mask or a video laryngoscope for subsequent introduction into the patient from an endotracheal tube, fluids and expired air from the patient, to avoid possible infections.
  • the device essentially has a sheet with sufficient dimensions to at least cover the face or head of the patient, with an opening for the introduction of the respiratory accessory, for example, a video laryngoscope or a coupler to a mask, and means of watertight retainers to fit said respiratory accessory, preferably a mask coupler or video laryngoscope to the opening in the foil.
  • the device preferably has a retention support plate, with greater rigidity than the sheet, and attached to it and the hermetic retention means, in order to keep the sheet at a distance from the patient, thus creating between the sheet and the patient's face a workspace.
  • the sheet acts as a shield, separating the professional from the patient to avoid possible infections in both directions, from the patient to the professional and vice versa.
  • the field of application of the present invention is framed in the sector of the industry dedicated to the manufacture of medical accessories and in particular medical accessories related to assisted ventilation of patients and in general with respiratory devices.
  • the objective of the present invention is to provide a means to avoid said contagion without limiting the vision or the need for proximity between the professional and the patient during the processes that require contact by the professional with the patient's upper airway, enabling the supply of assisted ventilation, as well as successful intubation.
  • the present invention has as its first object a protection device for processes that require contact with the airway of a patient with the ultimate aim of providing assisted ventilation to the same, for example, by placing a mask and its corresponding respirator, or by intubation with a video laryngoscope according to claim 1.
  • the device of the present invention could be used in other processes that present a risk of contagion and require contact with the upper airways of a patient through the placement or introduction of any medical device in them.
  • the present device has a sheet with sufficient dimensions to cover, at least, the head of a patient, said sheet presenting: an upper surface, facing the professional in charge of contacting the airways, for example, to place a breathing accessory , such as a mask and its accessories or a video laryngoscope to perform an intubation, determining the clean side, and a lower surface, facing the patient determining the side likely to be contaminated or dirty side, a first opening for the introduction of the respiratory accessory , preferably one end of a mask coupler with means for connect to a mask and a respirator, this coupler specially designed to connect to the first opening, or a video laryngoscope, and a hermetic retention means for the hermetic adjustment of said respiratory accessory, mask coupler or video laryngoscope, to said first opening of the sheet, specifically the end of the coupler opposite the tubular end that is attached to the mask (between both ends there is another tubular coupling for the connection of a respirator) or the proximal end of the video lary
  • the head of the professional or intubator is separated from the head of the patient, by means of the sheet.
  • a mask connection coupler or video laryngoscope through the first opening of the sheet, its distal part is below the sheet, that is, on the side that will face the patient , or dirty side.
  • the professional introduces his arms under the sheet to hold the mask coupled to the connection coupler or the proximal end of the video laryngoscope, that is, the handle, keeping his head above said sheet and away from the patient, to later hold the mask on the patient or introduce the distal end of the video laryngoscope into the patient's mouth, and in the latter case, to later introduce the endotracheal tube that is also below the lamina.
  • the respirator will also be connected to the mask coupler, so that the professional can activate the respirator and hold the mask on the patient from the dirty side.
  • the clean side where the head of the professional or intubator is located, the viewer of the video laryngoscope will be located or the video laryngoscope display screen attached to the proximal end of the same or some will come out of the video laryngoscope. cables for connection to a screen or electrical connection, depending on the characteristics of the video laryngoscope.
  • the device object of the present invention is not limited to being used with a specific respiratory accessory, specific type of mask or with a specific video laryngoscope, but can be used with any type of mask or video laryngoscope, among other respiratory accessories, for which it will be necessary adapt to each specific case the first opening in the sheet and the hermetic retention means between the opening in the sheet and the respiratory accessory.
  • Said airtight retention means may comprise: an airtight fastening element of the respiratory accessory, for example, mask coupler or video laryngoscope, with means for holding a mask coupler and / or video laryngoscope, preferably its handle, and means for attaching to the sheet, and / or a reinforcing support plate with a hole coinciding with the first hole of the sheet, preferably adhered to the sheet, to give rigidity to the sheet and facilitate the connection between the coupler or the video laryngoscope to the sheet , as well as to separate the sheet from the patient during the placement of the mask or intubation, and / or a complementary sealing element, to reinforce the seal between the upper surface of the sheet and / or the hermetic clamping piece and / or or the mask coupler or the video laryngoscope.
  • an airtight fastening element of the respiratory accessory for example, mask coupler or video laryngoscope
  • means for holding a mask coupler and / or video laryngoscope preferably
  • the hermetic fastening element can be the same regardless of the respiratory accessory to be coupled, that is, the same fastening element can be used to receive a mask coupler and to receive a video laryngoscope.
  • the protection device could have a hermetic fastening element and / or a support plate and / or a complementary sealing element.
  • the hermetic fastening element can be a piece that can be attached to the protection device or a piece that is part of the respiratory accessory itself, mask coupler or video laryngoscope, in the latter case in particular arranged on the handle or proximal end thereof. .
  • the protection device may or may not incorporate a retention support plate, although preferably it incorporates it, which will give consistency. to the sheet and at the same time will help to achieve a better retention of the hermetic fastener on the device.
  • the last component, the complementary sealing element may or may not be incorporated into the device, depending on the respiratory accessory, both the mask coupler and the video laryngoscope, or the rest of the components used as hermetic retention means.
  • the air-tight fastener of the breathing accessory, Mask or video laryngoscope can have different constructions and components, for example, among other possible constructions, it can comprise: a tubular piece of plastic material, preferably ABS or similar, preferably manufactured by injection, and joined at its upper end to the lower surface of the sheet or of the support plate, the hollow of the tubular body coinciding with the first hole in the sheet.
  • a tubular piece of plastic material preferably ABS or similar, preferably manufactured by injection, and joined at its upper end to the lower surface of the sheet or of the support plate
  • the hollow of the tubular body coinciding with the first hole in the sheet.
  • the hollow of the tubular body whose section of the hollow is preferably complementary with the external shape of the respiratory accessory, mask coupler or handle or body of the video laryngoscope, and in which said respiratory accessory is inserted, it preferably has an interior gasket.
  • tubular body in the perimeter of the hole, to improve the tightness in the union with the respiratory accessory, while the outer shape of the tubular body does not present any limitation; and / or a tubular piece of plastic material into which the respiratory accessory is inserted, similar to the previous one, but that to achieve the hermetic closure between both an elastic tape is arranged that is compressed by actuating a cam; and / or a piece of plastic material with a tubular body and into which the respiratory accessory is inserted, where the tubular body has a rubber or neoprene-like material in its interior hole, which determines an interior hole in the piece that is not complementary to that of the breathing accessory, mask coupler, or video laryngoscope body or handle.
  • Said part with a tubular body can be opened, for example by means of a hinge, for the introduction of the respiratory accessory into its interior and subsequently closed so that the material of the interior hole adapts to the shape of the outer body of the respiratory accessory.
  • the closing means can be of a different type, such as a flange or the like.
  • This piece of tubular body is subsequently attached to the sheet or to the support plate by, for example, an adhesive tape that ensures airtightness between the upper end of the tubular piece and the lower surface of the sheet or support plate; and / or a piece with an annular body of elastic material, attached or coupled to the perimeter of the first opening of the sheet or of the opening of the support plate, and into which the respiratory accessory is inserted in a tight manner; and / or An adhesive tape preferably adhered to the lower surface of the sheet or the support plate and which can also be adhered to the respiratory accessory, preferably to the mask coupler or to the handle of the same, so that a part of the tape is adhered to the sheet and another part of the tape adheres to the respiratory accessory after its introduction in the first hole, closing the gap that may exist between the sheet and the respiratory accessory and therefore achieving a hermetic closure at the junction between said first opening and the respiratory accessory, mask coupler or handle of the video laryngoscope.
  • an adhesive tape that ensures airtightness between the upper end
  • any of the previous hermetic fastening elements and the sheet or the support plate can be carried out in different ways, for example, by means of adhesives between both elements (in the case of tubular pieces, placing the adhesive between the upper end of the part, which preferably has a perimeter fin, and the lower surface of the sheets), which may or may not be combined with projections on the fastening element that engage in holes in the sheet; or pressure introduction of the hermetic fastening element in the sheet, preferably in the support plate; or as progress has been made through the use of masking tape.
  • hermetic fastening element could, depending on the preferred embodiment, be integrated into the respiratory accessory itself, for example, in the mask-to-mask coupler or in the handle or proximal end of the video laryngoscope.
  • the retention means may be suitably particularized, depending on the respiratory accessory to which the device is intended, type of mask coupler or video laryngoscope model, to guarantee its hold and the hermeticity or watertightness in the union between both, so preferably the hermetic retention means comprise a tubular body whose interior is complementary to the body of the respiratory accessory that is inserted into said tubular body and its exterior is complementary to the first opening.
  • the dimensions of the sheet should be such that they cover at least the head or face of the patient, although preferably they also extend to cover the chest of the patient.
  • the sheet can have different shapes, such as, for example, circular, square or rectangular with rounded corners, rectangular with two decreases in width in the area where the respiratory accessory is located to facilitate the introduction of the arms of the professional or intubator under the blade for the manipulation of the laryngoscope, and even two lateral openings for the introduction of the arms of the professional or intubator from the upper side to the lower side.
  • openings will allow the introduction of the arms in a tight manner (for example, cuts in the sheet or openings with overlapping layers of a flexible material that allow the introduction of the arm, etc.) to keep the space above the sheet separate, clean side, of the space below it, dirty side.
  • the openings can be approximately circular and have on the lower surface, joined to each one, by means of an adhesive or by heat welding, a tubular sleeve of plastic material also, which at the opposite end to the one joining the sheet , have an elastic element that decreases its diameter, so that, when the professional's hands are inserted, each cuff is perfectly adjusted on the wrist or arm, thus ensuring hermeticity or watertightness.
  • the plastic material of these sleeves is preferably PVC or a medical grade plastic, which is transparent, and with a thickness preferably between 30 pm and 100 pm, more preferably 50 pm.
  • the protection device can also incorporate adhesive tapes or other equivalent elements on the upper surface of the sheet, for example, ropes, which serve to be able to fasten the sheet to fastening elements other than the protection device, for example, wires. or cables arranged over hospital beds.
  • the sheet is flexible, with a thickness preferably between 20 pm and 80 pm, more preferably 50 pm, and preferably of a plastic material, preferably PVC or a medical grade plastic, which is also transparent for the professional or person who performs. intubation can see through the foil to correctly position the breathing accessory and place the mask and / or insert the endotracheal tube.
  • the flexibility of the sheet allows it to be folded for folding, for example, for packaging and / or to adopt a suitable shape to cover the patient.
  • the protection device is to be used for intubation, and to be effective in cases where the video laryngoscope integrates a channel to guide the endotracheal tube, and therefore, at the beginning of intubation, the proximal end of the endotracheal tube protrudes from the proximal end of the handle of the video laryngoscope, whereby the blade comprises a second opening that is adjacent to the first opening and has, attached to said second opening, a container or bag, for receiving said proximal end of the tube.
  • the only mouth of the container or bag is attached to the perimeter of the second opening preferably by an adhesive or by heat welding.
  • Said bag or container is attached to the upper surface of the sheet and its objective is to receive at least the endotracheal tube used for intubation, which may or may not incorporate a guide element inside it.
  • the endotracheal tube is inserted through the lower part of the sheet into the bag, or container, simultaneously with the introduction of the video laryngoscope in the first opening.
  • the intubator can manipulate the tube from the underside of the lamina with one hand while holding the video laryngoscope with the other.
  • Said bag or container is also preferably made of a plastic material, preferably PVC or a medical grade plastic, also transparent, and with a thickness preferably between 30 pm and 100 pm, more preferably 50 pm.
  • a possible component of the hermetic retention means of the device is a reinforcing support plate attached, preferably, to the lower surface of the sheet.
  • the reinforcement support plate has an opening coinciding with the first opening of said sheet to also allow the attachment of the hermetic fastening element to said first opening, said hermetic fastening element being adjusted to the opening of said reinforcing support plate, but in In this case, instead of being attached to the lower surface of the sheet, the retention means are attached to the support plate, which in turn remains attached to the sheet as mentioned above.
  • this support plate is, in addition to giving consistency to the union between the hermetic clamping element and the sheet, to create a ceiling over the patient's head during the placement of the mask or intubation to prevent as much as possible that the sheet comes into direct contact with the patient's face and avoid discomfort for the patient if he is conscious during the previous process, mask placement or intubation.
  • This support plate creates a space above the patient's face that allows the breathing accessory to be manipulated with precision.
  • Said reinforcement support plate can have different configurations, for example, circular, elliptical, square or rectangular with rounded corners to avoid damaging the sheet to which it is attached.
  • the support plate will preferably have a recess that it will coincide with said second opening to be able to access the bag or container of the endotracheal tube. Also, this recess facilitates the manipulation of the endotracheal tube from the lower side of the sheet.
  • the opening of the support plate coinciding with the first opening of the sheet, through which the respiratory accessory is introduced is arranged adjacent to the side of the reinforcing support plate that is closest to the patient's chest during insertion of the accessory. respiratory tract, especially during the introduction of the video laryngoscope in order not to hinder the introduction of the distal part of the video laryngoscope into the patient's mouth.
  • the support plate is made of a plastic material, more rigid than the previous ones, and preferably also made of PVC or a medical grade plastic, and also transparent, with a thickness preferably between 1.5 mm and 3 mm, more preferably 2 mm .
  • the surface of the support plate and the vertical axis of the sealing fastener preferably have an angle between them that is less than 90 ° and greater than 70 °.
  • the reason for this inclination of the clamping element with respect to the support plate, and the sheet, is to facilitate the introduction of the respiratory accessory into the patient's mouth, especially when it is a video laryngoscope due to its length and the curve that is necessary. do for its introduction in the mouth, to avoid that the accessory hits the chest of the patient.
  • Another possible component of the hermetic retention means is said complementary sealing element to reinforce the seal between the hermetic fastening element and the sheet or the support plate, depending on whether or not the protection device comprises said support plate.
  • This complementary sealing element is arranged on the upper surface of the sheet to reinforce, on the upper side of the sheet, the seal between the upper surface of said sheet and / or the hermetic fastening element and / or the respiratory accessory, coupler mask or video laryngoscope handle.
  • This complementary sealing element will preferably be a cover, although it can also be an adhesive tape, or both, depending on the type of respiratory accessory to be used with the protection device.
  • the respiratory accessory can be a video laryngoscope, and within these it can be one of any of the known types.
  • a video laryngoscope type Airtraq ⁇ or similar which is distinguished because the image is viewed through a viewfinder at its proximal end or a connected camera in the viewer and because it incorporates a channel where the endotracheal tube is housed
  • a video laryngoscope type Glysdescope ⁇ that is distinguished by the fact that the image is viewed through a screen separate from the handle to which the image arrives through a cable connected to said handle and because it does not have a channel where the endotracheal tube is housed
  • a McGrath ⁇ type video laryngoscope whose main characteristic is that the image is viewed through a screen integrated in the handle and because it does not have a channel where the endotracheal tube is housed.
  • said cover is arranged on the upper surface of the latter, which is attached to said upper surface of the sheet.
  • Said cover allows the connection of a camera with this type of video laryngoscope on the proximal end of the handle and has an upper and a lower opening for the transmission of the image that comes from the distal end of the video laryngoscope to the outside of it.
  • This cover is preferably made of a plastic material, preferably PVC or medical grade plastic, and also transparent, with a thickness preferably between 5 pm and 35 pm, more preferably 20 pm.
  • the cover preferably has, for its hermetic connection to the sheet, a lower projection that is inserted inside the first hole, between said hole and the hermetic fastening element or the video laryngoscope, and a lateral flap that is arranged, preferably by adhesion , on the upper surface of the sheet, thus helping to prevent contamination from passing from the lower side of the sheet to the upper side and vice versa.
  • an adhesive tape may be arranged around the first hole so as to hermetically join the upper surface of the sheet with the video laryngoscope.
  • the handle of the video laryngoscope will be inserted into the first opening through the lower part of the sheet being attached to it through the hermetic retention means.
  • On the upper surface there is a cover that helps to guarantee the tightness between the laryngoscope or video laryngoscope and the sheet.
  • the vision system On said cover the vision system will be attached, preferably a camera or media transmission of the image to a monitor, which will assist the intubator in introducing the endotracheal tube into the patient.
  • the video laryngoscope can be inserted into the first hole through the top side of the sheet.
  • the patient can be intubated.
  • the professional or intubator will hold the video laryngoscope by the lower part of the film or dirty side with his hands, keeping his head on the upper part of it or clean side, so that both heads, that of the intubator and the of the intubated patient are separated by the blade, but the hands of the intubator are on the underside without interference from the blade.
  • the endotracheal tube is introduced into the patient.
  • the distal end of the endotracheal tube is located in the channel of the video laryngoscope and the proximal end housed in the bag or container of the device object of the invention, so that during intubation the intubator can slide the endotracheal tube into the patient with one hand, specifically towards the trachea, while holding the video laryngoscope with the other hand.
  • said endotracheal tube is located during intubation in the hand of the intubator and below the sheet, it is not necessary for the protective device object of the invention to comprise the bag or container cited above.
  • the video laryngoscope is withdrawn from the mouth next to the sheet, keeping the endotracheal tube in the patient.
  • An intubator assistant who has not been in contact with the dirty side below the protective device, can remove the camera from the laryngoscope or disconnect the cables from the video laryngoscope that have always remained isolated from the patient, and therefore have not been contaminated, for later reuse.
  • a mask coupler that preferably will have a hollow body and that will at least comprise: A first hole for the outlet of air arranged at its lower end or distal end to be coupled to the face mask or helmet that will be arranged on the patient's face,
  • the mask coupler therefore connects to the mask, or helmet, through the first hole to subsequently connect to the first opening of the device from the lower surface of the sheet, using the corresponding airtight retention means.
  • the coupler is also connected to a respirator, usually manual, and operated by the professional from the dirty side, that is, below the sheet. The professional, therefore, keeps one hand on the mask or helmet on the patient and with the other can operate the manual respirator.
  • the sheet and its components, as well as the respiratory accessory, mask coupler, and the video laryngoscope attached to the sheet they can be reused after disinfection and sterilization by any of the known means if the materials of the different components allow it. , or they can be directly discarded.
  • the system for processes that require contact with the upper airway of a patient will include:
  • a device according to any of the alternatives described above, and A respiratory accessory coupled to the first hole of said device.
  • the respiratory accessory may be a mask coupler, a video laryngoscope with or without a guide channel for the endotracheal tube, with the screen integrated in the handle of the video laryngoscope, or a screen that can be attached to the viewfinder or the handle.
  • the method of handling the protection device comprises at least the following stages: a) Introduction by a medical professional of the respiratory accessory in the first job of the sheet from the bottom or top of it and ensure its tightness. In the case of the mask coupler, it will be inserted through the lower part, while in the case of a video laryngoscope, the handle, or proximal end, of the same will be inserted in the first opening, through the lower part of the sheet or through the top of it, depending on the type of video laryngoscope.
  • the hermetic retention means of the device will be used to ensure the hermetic coupling between the foil and the breathing accessory.
  • the respiratory accessory is a video laryngoscope
  • the professional will hold it with his hands by the distal end of the handle or video laryngoscope, below the blade, and then proceed to the introduction of the distal end of the laryngoscope or video laryngoscope , through the patient's mouth, and subsequent manipulation of the endotracheal tube for its introduction through the vocal cords of the patient, keeping the hands of the medical professional, or intubator, by the lower part of the blade and his head separated by the upper part of the device sheet.
  • the medical professional in addition to connecting the coupler to the device, must connect, or have previously connected the mask and respirator to said coupler. In this way, and always operating from the lower part of the sheet, or dirty side, the professional will be able to hold the mask on the patient with one hand and with the other hand to activate the breathing when it is manual.
  • the protection device of the invention can be used consecutively on a patient with different respiratory accessories.
  • the protection device could be used with a mask coupler, for which the mask connected to the respirator would be connected to it and later the assembly would be coupled to the protection device.
  • the device is placed on the patient, in particular on the mouth and nose, and oxygen is supplied, thus providing assisted ventilation. to the patient and keeping the patient separate from the medical professional to avoid possible contagion.
  • the mask and coupler could be removed from the lower part of the sheet of the protection device and the video laryngoscope could be inserted into said device to proceed with the introduction of the video laryngoscope into the patient, maintaining the separation between the patient and the medical professional.
  • the medical professional proceeds to intubation the patient by pushing the endotracheal tube inside the patient and following its trajectory with the visualization means of the laryngoscope.
  • Figure number 1 shows a top perspective view of the protective device object of the invention and an enlargement of a detail of a hermetic retention means for a video laryngoscope in the protection device.
  • Figure number 2 shows the elements of the invention, a sheet with two openings and a bag or container before being attached to one of said openings.
  • Figure number 3 shows a hermetic retention means of the device of the invention in the process of being assembled to a reinforcing support plate attached to the sheet of the device.
  • Figure number 4 shows the hermetic retention means of figure 3 with a cover of said means prior to their assembly.
  • Figure number 5 shows the installation of the hermetic retention means in a sheet with the bag or container incorporated.
  • Figure 6A shows a protection device, object of the invention, without a bag or container, with a video laryngoscope attached to the sheet, the video laryngoscope being of the Glydescope ⁇ type or similar, without an endotracheal tube channel or integrated screen, having a cable that connects the laryngoscope handle to a vision and / or power supply system.
  • Figure number 6B shows a protection device, object of the invention, without bag or container, with a video laryngoscope attached to the sheet, the video laryngoscope being of the McGrath ⁇ type or similar, without a channel for an endotracheal tube, but with a screen incorporated into its handle.
  • Figure 6C shows a protection device, object of the invention, with a bag or container for the endotracheal tube, with a video laryngoscope attached to the sheet, the video laryngoscope being of the Airtraq ⁇ type or similar, with a channel for the endotracheal tube and with a viewer at the proximal end of the handle to which a screen can be attached, observing how the end of the endotracheal tube is inserted into the bag or container.
  • Figure 7 shows the solution of Figure 6C with the video laryngoscope inserted into a patient, observing how the sheet covers the patient's head, how the arms operate through the lower part of the sheet, one hand holding the video laryngoscope and the other the endotracheal tube, with the proximal end of the endotracheal tube inserted into the bag or guide.
  • the head of the intubator is positioned above the lamina, separated from the head of the patient, facing the screen to allow intubation.
  • Figure 8 shows a device according to the present invention with a video laryngoscope of the type shown in Figures 6C and 7 prior to intubation and without the screen connected.
  • Figure 9 shows a section A-B of the device with a video laryngoscope (not sectioned) according to figure 8.
  • Figure 10 shows a perspective view of a protection device according to the present invention with two tubular bags for the introduction of the arms and the professional from the clean side to the dirty side.
  • Figures 11A and 11B show two perspective views of a mask coupler.
  • Figure 12 shows a section CD of Figure 10.
  • Figures 13 and 14 show two perspective views of a mask coupler connected to the protection device.
  • Figure 15 shows a side view of any of the previous figures.
  • Figure 16 shows a section E-F of the figure of view 14.
  • Figure 17 shows the device of Figures 12 to 15 with the mask coupler connected to a respirator and to a mask placed on a patient, observing how the sheet covers the patient's head, as the arms operate by the lower part of the sheet introduced into the two tubular bags, while one hand holding the mask and the other the respirator.
  • the head of the medical professional is positioned above the lamina, separated from the head of the patient.
  • Figures 1 to 5 show a preferred protection device object of the invention that can be coupled to a respiratory accessory, which will preferably be a mask coupler or a video laryngoscope.
  • the mask coupler will preferably have means for connecting a mask and respirator thereto, which may be either manually activated or automatically activated.
  • a protection device for a respiratory accessory is observed with a sheet 2 of a flexible and transparent plastic material, with an upper surface and a lower surface with a first opening 3 and a hermetic retention means 7 for the hermetic adjustment of the respiratory accessory to sheet 2, so that the space on the upper surface of the sheet is kept separate and isolated from the space below the lower surface of the sheet, preventing microorganisms from passing from one side of the sheet to the other through the hermetic retention means 7.
  • Said sheet 2 preferably has a rectangular shape with its rounded corners with sufficient dimensions to cover the head and thorax of the patient on whom the respiratory accessory is to be placed.
  • Sheet 2 is preferably PVC with a thickness preferably 50 ⁇ m.
  • Said hermetic retention means 7 may comprise: a hermetic holding element 73 of the respiratory accessory, mask coupler or video laryngoscope, preferably its handle, with means to hold said accessory and means to join the sheet, and / or a reinforcing support plate 71 with a hole coinciding with the first hole of the sheet, preferably adhered to the sheet, to give rigidity to the sheet and facilitate the union between the respiratory accessory and the sheet, as well as to separate the sheet from the patient during disposition of the respiratory accessory to provide assisted ventilation or to proceed with intubation, and / or a complementary sealing element 72, to reinforce the sealing between the upper surface of the sheet 2 and / or the hermetic clamping piece 73 and / or the respiratory accessory, which may be, for example, a cover 72 or an elastic strap.
  • Figure 3 shows how the previous elements are coupled to each other, that is, the hermetic fastening element 73 attached to the lower surface of the support plate 71 and in figure 4 the coupling of the complementary sealing element 72, in this case a cover, on the upper side of the support plate 71.
  • the sheet 2 arranged between said cover 72 and the support plate 71, is not included, being the latter attached to the lower surface of said sheet 2.
  • the different retention means 7, and in particular the hermetic fastening element 73, will be conveniently customized, according to the video laryngoscope and / or mask coupler model to which the device 1 is intended, to guarantee its hold and the hermetic or watertightness.
  • the hermetic retention means 7 comprise a tubular body 73 whose interior is complementary to the respiratory accessory body, coupler or video laryngoscope and its exterior is complementary to the first opening 3.
  • Figure 3 shows observes a hermetic fastening element 73 that preferably has a piece of plastic material 73 with a tubular body, of approximately square or rectangular section, preferably made of an ABS or similar material, attached to the lower part of the sheet 2, and in which Inside, the mask or video laryngoscope coupler is inserted, preferably its handle.
  • the means for joining the tubular body 73 to the sheet 2 or to the reinforcing support plate 71 may be of a different nature, such as, for example, holes in the sheets 7, 71 complementary to projections in the fastening element 73.
  • FIG 3 shows holes 711 in the support plate 71 where projections 731 are inserted in the annular element and which are arranged in a fin at the upper end of said hermetic fastening element 73.
  • the Joining means can be pressure, by means of adhesives and / or thermo-welding between both components.
  • Said fastening element 73 may incorporate a hook 732 to facilitate the holding and orientation of the proximal end of the endotracheal tube and its easy insertion in the lower zone of a bag 51 arranged on the upper side of the sheet 2 (which will be described later).
  • the retention means 7 may comprise a reinforcing support plate 71 ( Figures 1 and 3 to 7), with an opening 713 coinciding with the first opening 3 of the sheet 2.
  • the purpose of said reinforcing support plate 71 is to create a bell over the head of the patient 10 to avoid direct contact of the sheet 2 on the patient during the provision of the respiratory accessory, the performance of mask ventilation or intubation and also provide a workspace for the medical professional, or intubator, to manipulate the mask and / or a respirator also attached to the mask coupler, or the video laryngoscope in comfort.
  • the hermetic fastening element 73 is fitted on said sheet.
  • the support plate can have a recess 712 ( Figures 1 and 3 to 7) to, among other features, facilitate the handling of the endotracheal tube 413, or the respirator, from the underside of the sheet 2.
  • Said support plate 71 is preferably made of a transparent plastic material, such as PVC with a greater rigidity than the sheet material, and preferably a thickness of preferably 2 mm.
  • the hermetic fastening element 73 may have different constructions, adapted both to the shape of the first opening 3 in the sheet 2 and to the shape of the accessory. respirator that is inserted inside the annular element 73.
  • the fastening element 73 will usually adapt to the shape of the video laryngoscope, while, on the contrary, it will be the mask coupler that adapts to the clamping element 73. This will be the case because preferably the same protection device 1 will be used to perform an intubation with a video laryngoscope that will be preceded by the use of a mask with a coupler to supply oxygen to the patient prior to intubation .
  • Different hermetic fasteners 73 could be:
  • the hermetic fastening element of the respiratory accessory can have different constructions and components, for example, among other possible constructions, it can comprise: a tubular piece 73 of plastic material joined at its upper end to the lower surface of the sheet 2 or of the plate support 71, the hollow of the tubular body coinciding with the first hole 3 of the sheet 2.
  • the tubular body 73 In the hollow of the tubular body 73, whose section of the hollow is preferably complementary with the outer section of the respiratory accessory, mask coupler and / or handle or body of the video laryngoscope, and into which said accessory is inserted respiratory system, being able to present an internal gasket around the perimeter of the hole, to improve the hermeticity with the joint of the respiratory accessory, while the outer section of the tubular body 73 does not present a limitation; and / or a tubular piece 73 of plastic material in which the respiratory accessory is inserted, similar to the previous one, but that to achieve the hermetic closure between both an elastic tape is arranged that is compressed by actuating a cam; and / or a tubular piece of plastic material and into which the respiratory accessory is inserted, where the tubular body has a rubber or neoprene-type material in its interior hole, which determines an interior hole in the piece that is not complementary to that of the respiratory accessory.
  • Said tubular piece can be opened, for example by means of a joint, for the introduction of the respiratory accessory into its interior and subsequently closed so that the material of the interior hole adapts to the shape of the outer body of the respiratory accessory.
  • the closing means can be of a different type, such as a flange or the like.
  • This tubular piece would subsequently be joined to the sheet or the support plate by means of, for example, adhesive or an adhesive tape that guarantees the airtightness between the upper end of the tubular piece and the lower surface of the support sheet or plate; and / or a piece with an annular body of elastic material, attached or coupled to the perimeter of the first opening of the sheet or of the opening of the support plate, and into which the respiratory accessory is inserted in a tight manner; and / or An adhesive tape, preferably adhered to the lower surface of the sheet or of the support plate, and that can also be adhered to the respiratory accessory, so that a part of the tape is adhered to the sheet and another part of the The tape adheres to the respiratory accessory after its introduction into the first hole, closing the gap that may exist between the sheet and the respiratory accessory and therefore achieving a hermetic seal at the junction between said first opening 3 and the respiratory accessory.
  • adhesive or an adhesive tape that guarantees the airtightness between the upper end of the tubular piece and the lower surface of the support sheet or plate
  • the third possible component of the hermetic retention means 7 is the aforementioned complementary sealing element 72 (see figures 1, 3 and 4) to reinforce the seal between the hermetic clamping piece 73 and the sheet 2 or the support plate 71, depending on whether or not the protection device 1 comprises said support plate 71.
  • This complementary sealing element 72 is arranged on the upper surface of the sheet 2 to reinforce, on the upper side of said sheet 2, the seal between the upper surface and / or the hermetic fastening element 73 and / or the accessory. respirator, either the mask coupler or the video laryngoscope, preferably its handle.
  • This complementary sealing element will preferably be a cover 72, although it can also be an adhesive tape, depending on the type of respiratory accessory to be used with the protection device 1.
  • FIGS. 13 and 15 show a cover 72 of said retention means 7 attached to said upper surface of sheet 2.
  • Said cover 72 is specially designed for a video laryngoscope and has a tubular body with an opening It allows, see Figure 6C, the connection of a camera 412 on the proximal end of the handle 410 of this type of video laryngoscope 41.
  • a cover 72 like the previous one can be seen that for use with A mask coupler 9 has the upper opening of the cover covered, preferably with an adhesive tape. This prevents possible microorganisms from escaping from the bottom of the sheet 2 to the top of it.
  • This cover 72 is preferably made of a transparent plastic material, preferably PVC with a thickness preferably of 20 ⁇ m.
  • the protection device 1 with a video laryngoscope 42, 42, 43 will be described as a respiratory accessory, in particular with reference to Figures 6A, 6B, 6C, 7 and 8.
  • sheet 2 comprises a second opening 5 which is adjacent to the first opening 3 and has, joined to said second opening 5, a container or bag 51 (see figure 2).
  • the only mouth 5 of the container or bag 51 is joined to the perimeter of the second opening 5 preferably by an adhesive or by heat welding.
  • Said bag or container 51 is attached to the upper surface of sheet 2 (see figure 2) and its objective is to receive at least the endotracheal tube 413 used for intubation and which may or may not incorporate a guide element inside it.
  • the endotracheal tube 413 is inserted into the bag 5, or container, through the lower part of the sheet 2 and simultaneously with the introduction of the video laryngoscope in the first opening 3. During and after intubation the The intubator will be able to manipulate tube 413 from the underside of sheet 2 with one hand while holding the video laryngoscope with the other hand.
  • Said bag or container 51 is also preferably made of a transparent plastic material, preferably PVC with a thickness preferably of 50 pm.
  • the protection device 1 object of the invention may be used with different types of video laryngoscopes, by means of slight adaptations of the device 1 to the characteristics and geometries of the handles of the different video laryngoscopes.
  • Figure 6C shows a device 1 object of the invention for use with a video laryngoscope type Airtraq ⁇ or similar 41, these being of the type that have a handle 410 at the proximal end of the video laryngoscope 41 and on which a viewer is attached. or a chamber 412, and may also include a lateral channel to facilitate the introduction and guidance of the endotracheal tube 413 in the patient.
  • the handle 410 of the video laryngoscope 41 is inserted into the hermetic holding element 73 through the lower part of the sheet 2, by which to ensure the tightness of the connection between the hermetic fastening element 73 and the sheet 2, the aforementioned cover 72 is arranged on the upper surface of the sheet, and attached thereto ( Figures 1 and 4)
  • the device 1 also has a bag or container 51 to house the endotracheal tube 413 during the intubation process.
  • the device 1 of the present invention with a video laryngoscope 41, type Airtraq ⁇ or similar, prior to the connection of the screen 412, can be seen in Figures 8 and 9.
  • FIG. 6A An alternative to the protective device 1 above, for use with a Glydescope ⁇ type video laryngoscope and featuring a single body 430 with a 431 cable connection 432 at the proximal end of the video laryngoscope 43, and without an introduction channel for a Endotracheal tube is shown in Figure 6A.
  • the protective device 1 comprises a sheet 2, without a second opening or bag, although it does present the hermetic retention means 7 that comprise a support plate 71 and a hermetic clamping element 73.
  • Said hermetic clamping element 73 will be adapted internally to the outer shape of the proximal end of the video laryngoscope and externally to the shape of the opening 3.
  • the introduction into the first hole 3 of the protection device 1 is carried out through the upper surface of the sheet 2 and subsequently the video laryngoscope 43 is introduced into the patient.
  • the video laryngoscope 43 is held by its body 430, keeping the hands below the sheet 2 and the head of the intubator above said sheet, so that the intubator does not share space with the patient, since said The space is divided in two by the lamina 2.
  • the endotracheal tube would also be inserted under the lamina 2.
  • connection means 431 could be separated from the body of the video laryngoscope 430, the coupling of the video laryngoscope with the protection device 1 object of the invention would be carried out as in the case described above.
  • the anterior protection device 1 with a McGrath ⁇ type video laryngoscope 42 and which presents a single body 420 with a screen 422 at the proximal end 421 of the video laryngoscope 42, and without a tube introduction channel. endotracheal, is shown in Figure 6B.
  • the protective device 1 comprises a sheet 2 without a second opening or bag, although it does present the hermetic retention means 7 that comprise a support plate 71 and a hermetic clamping element 73.
  • Said hermetic clamping element 73 will be adapted internally to the external shape of the proximal end of the video laryngoscope and externally to the shape of the opening 3.
  • the video laryngoscope 42 has a screen 422 at its proximal end 421
  • the introduction into the first hole 3 of the protection device 1 is made by the upper surface of the sheet 2 and then the video laryngoscope 43 is introduced into the patient.
  • the video laryngoscope 43 is held by its body 430, keeping the hands below the sheet 2 and the head of the intubator above said sheet, so that the intubator does not share space with the patient, since said space is divided in two by the sheet.
  • the endotracheal tube is also introduced below said sheet 2.
  • Figure 7 shows an example of a protection device 1 according to the invention arranged on a patient 8.
  • the professional or intubator will hold the laryngoscope with his hands 9 by the lower part of the sheet 2, equivalent to the dirty side, keeping his head by the upper part of it, equivalent to the clean side, so that both heads, that of the intubator and that of the intubated patient 8, are separated by plate 2, but the hands 9 of the intubator are on the lower side without interference from the Plate 2.
  • endotracheal tube 413 is introduced into the patient.
  • the distal end of the endotracheal tube 413 is located in the channel of the video laryngoscope 41 and the proximal end is housed in the bag or container 51 of the device 1 object of the invention, so that during intubation the intubator can with one hand 9 slide the endotracheal tube 413 into the patient 9, specifically towards the trachea, while with the other hand 9 holds the video laryngoscope 41.
  • the intubator can observe the entire intubation procedure through the screen 412. It is observed how the support plate 71 of the hermetic retention means 7 prevents contact of the blade 2 with the patient 8.
  • the video laryngoscope 41 is removed from the mouth of patient 8 next to plate 2, keeping the endotracheal tube 413 in patient 8.
  • An intubator assistant who has not been in contact with the dirty side located below the protective device 1, you can remove the camera 412 from the video laryngoscope 41 or disconnect the cables from the video laryngoscope 431, if possible, which have always remained isolated from the patient, and therefore have not been contaminated, to its subsequent reuse.
  • Figure 10 shows another example of protection device 1 according to the present invention. It can comprise the same elements as the previous ones, mainly a sheet 2, with a first opening 3 and a hermetic retention means 7.
  • the figure shows sheet 2, the bag or container 51 and the cover 72, elements already shown and described above.
  • the protection device 1 of this example has two openings 8, approximately circular, in the sheet 2, which have, joined by the lower surface of this sheet 2, a tubular sleeve 81, which is also preferably made of plastic. Said sleeves 81 are attached at one of their ends to the perimeter of the holes 8 of the sheet 2 by means of adhesive or by heat welding.
  • the sleeves 81 show a decrease in diameter, preferably caused by a elastic element, so that, when introducing the professional's hands, each tubular bag is perfectly closed on the hand, thus ensuring the hermeticity or watertightness.
  • the plastic material of these sleeves is preferably PVC or a medical grade plastic, which is transparent, and with a thickness preferably between 30 pm and 100 pm, more preferably 50 pm.
  • the protection device 1 can also incorporate on the upper surface of the sheet 2, adhesive tapes 21 that serve to hold the sheet 2 to fastening elements other than the protection device 1, for example, a bow arranged on the patient. that can be attached to the beds where surgical interventions are performed.
  • the protection device 1 described above in any of its embodiments, can be used with different respiratory accessories, either with video laryngoscopes, as described with reference to Figures 6A to 9, or with mask couplers 9 as shown in the Figures 9 to 16.
  • Figures 10A to 12 show an example of a mask coupler 9.
  • This mask coupler 9 will comprise a hollow body and at least:
  • a first hole 91 for the outlet of air arranged at its lower end or distal end to be coupled to the face mask 10 or helmet that will be arranged on the face of the patient 8,
  • FIGs 13 to 17 show a mask coupler 9 connected to a hermetic fastening element 73 of a protection device 1 according to the invention.
  • Said protection element 1 comprises a sheet 2, a plate 71 and a cover 72 with its hole covered, preferably by a removable adhesive tape.
  • the mask coupler 9 has on two of its side walls two slits 93 intended to receive two complementary projections arranged on the holding element 73 into which the mask coupler 9 is inserted.
  • Figure 17 shows a protection device 1 as shown in figure 10, with a mask coupler 9 and its accessories.
  • Said device 1 is arranged on a patient 8 and the mask coupler 9 therefore connects with the mask 10, or helmet, through the first hole 91 to subsequently connect with the first opening 3 of the device from the lower surface of the sheet 2, using the hermetic fastening element 73 of the retention means 7.
  • the coupler 9 is also connected to a respirator 20, manually and / or automatically operated, and operated by the professional from the dirty side, that is to say , below sheet 2. The professional, therefore, can keep one hand on the mask 10 or helmet on the patient 8 and with the other can operate or manipulate the respirator 20.
  • the sheet 2 and its components, as well as the breathing accessory attached to it they can be reused after disinfection and sterilization by any of the known means if the materials of the different components allow it, or on the contrary, they can be directly disposed of together with protection device 1.
  • the figures also show a protection system for the provision of a respiratory accessory over the upper airway of a person, either to provide assisted ventilation with a mask or to perform intubation with a video laryngoscope.
  • the system therefore comprises a respiratory accessory and a protection device as described above.
  • Figures 6A, 6B and 6C show, in addition to a protection device 1, a system for intubations, which is made up of a video laryngoscope 41, 42, 43 and a protection device 1 that it will essentially comprise a sheet 2 with an upper surface and a lower surface, a first opening 3 for the introduction of one end of a video laryngoscope 4 and a hermetic retention means 7 for the hermetic adjustment of said video laryngoscope 4 to said first opening 3 of plate 2.
  • a protection device 1 which is made up of a video laryngoscope 41, 42, 43 and a protection device 1 that it will essentially comprise a sheet 2 with an upper surface and a lower surface, a first opening 3 for the introduction of one end of a video laryngoscope 4 and a hermetic retention means 7 for the hermetic adjustment of said video laryngoscope 4 to said first opening 3 of plate 2.
  • Figures 13 to 17 also show, in addition to a protection device 1, a system for providing assisted ventilation with a mask or the like, which is made up of a mask coupler 9 and a protection device 1 that will essentially comprise a sheet 2 with an upper surface and a lower surface, a first opening 3 for the introduction of one end of the mask coupler 9 and a hermetic retention means 7 for the fit hermetic of said mask coupler 9 to said first opening 3 of the sheet 2.
  • the surface of the support plate 71 and the vertical axis of the sealing element 73 can have an angle between them that is less than 90 ° and greater than 70 °.
  • the reason for this inclination of the clamping element 73 with respect to the support plate 71, or vice versa, and the sheet 2, is to facilitate the introduction of the respiratory accessory into the patient's mouth. This inclination is especially useful when the respiratory accessory is a video laryngoscope, since due to its length and the curve that must be made to insert it into the mouth, it could hit or be difficult to insert into the mouth through the patient's chest 8 .
  • the method of manipulating the protection device for the provision of a respiratory accessory on the upper airway of a person will comprise at least the following stages: a) Introduction by a medical professional of the respiratory accessory in the first job of the sheet from the bottom or top of it and ensure its tightness.
  • a medical professional of the respiratory accessory in the first job of the sheet from the bottom or top of it and ensure its tightness.
  • the mask coupler it will be inserted through the lower part, while in the case of a video laryngoscope, the handle, or proximal end, of the same will be inserted in the first opening, through the lower part of the sheet or through the top of it, depending on the type of video laryngoscope.
  • the hermetic retention means of the device will be used to ensure the hermetic coupling between the foil and the breathing accessory. b) Holding the respiratory accessory with the hands of the medical professional by the lower part of the sheet while keeping the professional's head on the upper part of it.
  • the respiratory accessory is a video laryngoscope
  • the professional will hold it with his hands by the distal end of the handle or video laryngoscope, below the blade, and then proceed to the introduction of the distal end of the laryngoscope or video laryngoscope , through the patient's mouth, and subsequent manipulation of the endotracheal tube for its introduction through the patient's vocal cords, keeping the hands of the medical professional, or intubator, by the lower part of the blade and its head separated by the upper part of the device blade.
  • the medical professional in addition to connecting the coupler to the device, must connect, or have previously connected the mask and respirator to said coupler. In this way, and always operating from the lower part of the sheet, or dirty side, the professional will be able to hold the mask on the patient with one hand and with the other hand to activate the breathing when it is manual.

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Abstract

The invention relates to a protective device for placing a respiratory accessory over the upper airway to provide assisted ventilation and/or intubation with a video laryngoscope, in processes which require contact of a medical professional with the upper airway of a patient. The device comprises a sheet and the purpose thereof is to provide a physical barrier to protect the medical professional or person who handles and places the respiratory accessory on the patient, for example, a mask or a video laryngoscope for the subsequent introduction of an endotracheal tube into the patient, from the fluid and air expelled by the patient, in order to avoid potential infection. The device essentially has a sheet with dimensions sufficient for at least covering the face or head of the patient, with an opening for introducing the respiratory accessory and tight retaining means for fitting said respiratory accessory.

Description

DISPOSITIVO DE PROTECCIÓN PARA DISPOSICION DE UN ACCESORIO RESPIRATORIO SOBRE LA VIA AEREA SUPERIOR PARA PROPORCIONAR VENTILACION ASISTIDA Y/O INTUBACION CON VIDEO LARINGOSCOPIO PROTECTION DEVICE FOR DISPOSAL OF A RESPIRATORY ACCESSORY ON THE UPPER AIRWAY TO PROVIDE ASSISTED VENTILATION AND / OR INTUBATION WITH VIDEO LARYNGOSCOPE
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
La invención, dispositivo de protección para disposición de un accesorio respiratorio sobre la vía aérea superior para proporcionar ventilación asistida y/o intubación con un video laringoscopio, es empleado para procesos que requieran, por parte del profesional médico, contacto con la vía aérea superior de un paciente, por ejemplo, para proporcionar ventilación asistida, disponiendo una mascarilla de ventilación sobre el paciente, o para intubar con un video laringoscopio, es decir, disponer sobre el paciente un accesorio respiratorio empleado para facilitar la respiración del mismo. El dispositivo comprende una lámina y tiene como finalidad proporcionar una barrera física para proteger al profesional médico, o persona que manipula y dispone el accesorio respiratorio sobre el paciente, que por ejemplo puede ser, una mascarilla o un video laringoscopio para la posterior introducción en el paciente de un tubo endotraqueal, de los fluidos y aire expirado procedentes del paciente, para evitar posibles contagios. El dispositivo presenta, esencialmente, una lámina con unas dimensiones suficientes para al menos cubrir la cara o cabeza del paciente, con una abertura para la introducción del accesorio respiratorio, por ejemplo, un video laringoscopio o un acoplador a una mascarilla, y unos medios de retención herméticos para ajustar dicho accesorio respiratorio, preferiblemente un acoplador a una mascarilla o un video laringoscopio a la abertura de la lámina. Asimismo, el dispositivo presenta, preferiblemente, una placa soporte de retención, con mayor rigidez que la lámina, y unida a esta y a los medios de retención herméticos, con el objetivo de mantener la lámina a una distancia del paciente, creando así entre la lámina y la cara del paciente un espacio de trabajo. La lámina actúa como escudo, separando al profesional del paciente para evitar posibles contagios en ambos sentidos, del paciente al profesional y viceversa. The invention, a protection device for disposition of a respiratory accessory over the upper airway to provide assisted ventilation and / or intubation with a video laryngoscope, is used for processes that require, by the medical professional, contact with the upper airway of a patient, for example, to provide assisted ventilation, by placing a ventilation mask on the patient, or to intubate with a video laryngoscope, that is, to arrange on the patient a respiratory accessory used to facilitate the patient's breathing. The device comprises a sheet and is intended to provide a physical barrier to protect the medical professional, or person who handles and arranges the respiratory accessory on the patient, which for example can be a mask or a video laryngoscope for subsequent introduction into the patient from an endotracheal tube, fluids and expired air from the patient, to avoid possible infections. The device essentially has a sheet with sufficient dimensions to at least cover the face or head of the patient, with an opening for the introduction of the respiratory accessory, for example, a video laryngoscope or a coupler to a mask, and means of watertight retainers to fit said respiratory accessory, preferably a mask coupler or video laryngoscope to the opening in the foil. Likewise, the device preferably has a retention support plate, with greater rigidity than the sheet, and attached to it and the hermetic retention means, in order to keep the sheet at a distance from the patient, thus creating between the sheet and the patient's face a workspace. The sheet acts as a shield, separating the professional from the patient to avoid possible infections in both directions, from the patient to the professional and vice versa.
El campo de aplicación de la presente invención se enmarca en el sector de la industria dedicada a la fabricación de accesorios médicos y en particular accesorios médicos relacionados con la ventilación asistida de pacientes y en general con dispositivos respiratorios. ANTECEDENTES DE LA INVENCION The field of application of the present invention is framed in the sector of the industry dedicated to the manufacture of medical accessories and in particular medical accessories related to assisted ventilation of patients and in general with respiratory devices. BACKGROUND OF THE INVENTION
Como es sabido, las enfermedades altamente contagiosas por vía aérea, como por ejemplo es el caso del virus COVID-19, entre otros, hacen que se deban extremar las precauciones a la hora de tratar a los pacientes. En este sentido, la colocación de mascarillas de ventilación en pacientes, así como la posterior intubación y colocación de aparatos como video laringoscopios para guiar el tubo endotraqueal en el interior del paciente para el posterior acoplamiento a dicho tubo de un respirador, suponen un momento de alto riesgo de contagio por la cercanía del personal, encargado del proceso de ventilación asistida que ha de colocar la mascarilla así como de hacer la intubación, con la boca y nariz del paciente. As is known, highly contagious diseases by air, such as the COVID-19 virus, among others, make it necessary to take extreme precautions when treating patients. In this sense, the placement of ventilation masks in patients, as well as the subsequent intubation and placement of devices such as video laryngoscopes to guide the endotracheal tube inside the patient for subsequent attachment to said tube of a respirator, represent a moment of high risk of contagion due to the proximity of the personnel, in charge of the assisted ventilation process who must place the mask as well as perform the intubation, with the patient's mouth and nose.
El objetivo de la presente invención es proporcionar un medio para evitar dicho contagio sin limitar ni la visión ni la necesidad de proximidad entre profesional y paciente durante los procesos que requieran contacto por parte del profesional con la vía aérea superior del paciente, posibilitando el suministro de ventilación asistida, así como la realización correctamente de una intubación. The objective of the present invention is to provide a means to avoid said contagion without limiting the vision or the need for proximity between the professional and the patient during the processes that require contact by the professional with the patient's upper airway, enabling the supply of assisted ventilation, as well as successful intubation.
EXPLICACIÓN DE LA INVENCIÓN EXPLANATION OF THE INVENTION
La presente invención tiene como primer objeto un dispositivo de protección para procesos que requieren contacto con la vía aérea de un paciente con el fin último de proporcionar ventilación asistida al mismo, por ejemplo, mediante la colocación de una mascarilla y su correspondiente respirador, o mediante la intubación con un video laringoscopio conforme a la reivindicación 1. Asimismo, podría emplearse el dispositivo de la presente invención en otros procesos que presenten riesgo de contagio y requieran el contacto con las vías aéreas superiores de un paciente a través de la colocación o introducción de cualquier dispositivo médico en las mismas. The present invention has as its first object a protection device for processes that require contact with the airway of a patient with the ultimate aim of providing assisted ventilation to the same, for example, by placing a mask and its corresponding respirator, or by intubation with a video laryngoscope according to claim 1. Likewise, the device of the present invention could be used in other processes that present a risk of contagion and require contact with the upper airways of a patient through the placement or introduction of any medical device in them.
El presente dispositivo presenta una lámina con unas dimensiones suficientes para cubrir, al menos, la cabeza de un paciente, presentando dicha lámina: una superficie superior, enfrentada al profesional encargado de contactar con las vías aéreas, por ejemplo, para colocar un accesorio de respiración, tal como una mascarilla y sus accesorios o un video laringoscopio para realizar una intubación, determinando el lado limpio, y una superficie inferior, enfrentada al paciente determinando el lado susceptible de estar contaminado o lado sucio, una primera abertura para la introducción del accesorio respiratorio, preferiblemente un extremo de un acoplador de mascarilla con medios para conectarse a una mascarilla y a un respirador, especialmente diseñado este acoplador para conectarse a la primera abertura, o un video laringoscopio, y unos medios de retención herméticos para el ajuste, hermético, de dicho accesorio respiratorio, acoplador de mascarilla o video laringoscopio, a dicha primera abertura de la lámina, en concreto el extremo del acoplador opuesto al extremo tubular que está unido a la mascarilla (entre ambos extremos se dispone otro acoplamiento tubular para la conexión de un respirador) o el extremo proximal del video laringoscopio o mango de este, que es el extremo que se mantiene fuera de la boca del paciente en la intubación, mientras que el extremo distal es aquel que si se introduce en la boca del paciente. The present device has a sheet with sufficient dimensions to cover, at least, the head of a patient, said sheet presenting: an upper surface, facing the professional in charge of contacting the airways, for example, to place a breathing accessory , such as a mask and its accessories or a video laryngoscope to perform an intubation, determining the clean side, and a lower surface, facing the patient determining the side likely to be contaminated or dirty side, a first opening for the introduction of the respiratory accessory , preferably one end of a mask coupler with means for connect to a mask and a respirator, this coupler specially designed to connect to the first opening, or a video laryngoscope, and a hermetic retention means for the hermetic adjustment of said respiratory accessory, mask coupler or video laryngoscope, to said first opening of the sheet, specifically the end of the coupler opposite the tubular end that is attached to the mask (between both ends there is another tubular coupling for the connection of a respirator) or the proximal end of the video laryngoscope or its handle, which is the end that is kept outside the patient's mouth during intubation, while the distal end is the one that is inserted into the patient's mouth.
Mediante el dispositivo, la cabeza del profesional o intubador queda separada de la cabeza del paciente, por medio de la lámina. Tras la introducción del accesorio respiratorio, acoplador de conexión de una mascarilla o video laringoscopio, a través de la primera abertura de la lámina, su parte distal queda por debajo de la lámina, es decir, en el lado que se va a enfrentar al paciente, o lado sucio. El profesional introduce sus brazos por debajo de la lámina para sujetar la mascarilla acoplada al acoplador de conexión o el extremo proximal del video laringoscopio, es decir el mango, manteniendo su cabeza por encima de dicha lámina y alejado del paciente, para posteriormente sujetar la mascarilla sobre el paciente o introducir el extremo distal del video laringoscopio en la boca del paciente, y en este último caso, para posteriormente introducir el tubo endotraqueal que también se encuentra por debajo de la lámina. Por este lado inferior, se conectará también el respirador al acoplador de la mascarilla, de manera que el profesional pueda accionar el respirador y sujetar la mascarilla sobre el paciente por el lado sucio. Por el lado superior de la lámina, el lado limpio, donde se encuentra la cabeza del profesional o intubador, se situará el visor del video laringoscopio o la pantalla de visualización del video laringoscopio acoplada al extremo proximal del mismo o bien saldrán del video laringoscopio unos cables para su conexión a una pantalla o conexión eléctrica, dependiendo de las características del video laringoscopio. By means of the device, the head of the professional or intubator is separated from the head of the patient, by means of the sheet. After the introduction of the respiratory accessory, a mask connection coupler or video laryngoscope, through the first opening of the sheet, its distal part is below the sheet, that is, on the side that will face the patient , or dirty side. The professional introduces his arms under the sheet to hold the mask coupled to the connection coupler or the proximal end of the video laryngoscope, that is, the handle, keeping his head above said sheet and away from the patient, to later hold the mask on the patient or introduce the distal end of the video laryngoscope into the patient's mouth, and in the latter case, to later introduce the endotracheal tube that is also below the lamina. On this lower side, the respirator will also be connected to the mask coupler, so that the professional can activate the respirator and hold the mask on the patient from the dirty side. On the upper side of the sheet, the clean side, where the head of the professional or intubator is located, the viewer of the video laryngoscope will be located or the video laryngoscope display screen attached to the proximal end of the same or some will come out of the video laryngoscope. cables for connection to a screen or electrical connection, depending on the characteristics of the video laryngoscope.
El dispositivo objeto de la presente invención no está limitado a ser utilizado con un accesorio respiratorio concreto, tipo de mascarilla concreto ni con un video laringoscopio concreto, sino que puede ser empleado con cualquier tipo de mascarilla o de video laringoscopio, entre otros accesorios respiratorios, para lo cual será necesario adaptar a cada caso concreto la primera abertura en la lámina y los medios de retención herméticos entre la abertura de la lámina y el accesorio respiratorio. Dichos medios de retención herméticos pueden comprender: un elemento de sujeción hermética del accesorio respiratorio, por ejemplo, acoplador de mascarilla o video laringoscopio, con medios para sujetar un acoplador de mascarilla y/ o un video laringoscopio, preferiblemente su mango, y medios para unirse a la lámina, y/ o una placa soporte de refuerzo con un orificio coincidente con el primer orificio de la lámina, preferiblemente adherida a la lámina, para dar rigidez a la lámina y facilitar la unión entre el acoplador o el video laringoscopio a la lámina, así como para separar la lámina del paciente durante la colocación de la mascarilla o de la intubación, y/ o un elemento complementario de hermeticidad, para reforzar la hermeticidad entre la superficie superior de la lámina y/o la pieza de sujeción hermética y/o el acoplador de mascarilla o el video laringoscopio. The device object of the present invention is not limited to being used with a specific respiratory accessory, specific type of mask or with a specific video laryngoscope, but can be used with any type of mask or video laryngoscope, among other respiratory accessories, for which it will be necessary adapt to each specific case the first opening in the sheet and the hermetic retention means between the opening in the sheet and the respiratory accessory. Said airtight retention means may comprise: an airtight fastening element of the respiratory accessory, for example, mask coupler or video laryngoscope, with means for holding a mask coupler and / or video laryngoscope, preferably its handle, and means for attaching to the sheet, and / or a reinforcing support plate with a hole coinciding with the first hole of the sheet, preferably adhered to the sheet, to give rigidity to the sheet and facilitate the connection between the coupler or the video laryngoscope to the sheet , as well as to separate the sheet from the patient during the placement of the mask or intubation, and / or a complementary sealing element, to reinforce the seal between the upper surface of the sheet and / or the hermetic clamping piece and / or or the mask coupler or the video laryngoscope.
El elemento de sujeción hermética puede ser el mismo independientemente del accesorio respiratorio a acoplar, es decir, un mismo elemento de sujeción se puede emplear para recibir a un acoplador de mascarilla y para recibir a un video laringoscopio. The hermetic fastening element can be the same regardless of the respiratory accessory to be coupled, that is, the same fastening element can be used to receive a mask coupler and to receive a video laryngoscope.
Conforme a lo anterior, el dispositivo de protección podría presentar un elemento de sujeción hermética y/o una placa soporte y/o un elemento complementario de hermeticidad. El elemento de sujeción hermética puede ser una pieza que se puede unir al dispositivo de protección o una pieza que forma parte del propio accesorio respiratorio, acoplador de mascarilla o video laringoscopio, en este último caso en concreto dispuesta en el mango o extremo proximal del mismo. Independientemente de si el dispositivo de protección incorpora o no dicho elemento de sujeción hermética (como se ha mencionado puede estar incorporada en el propio accesorio respiratorio), el dispositivo puede o no incorporar una placa soporte de retención, aunque preferiblemente la incorpore, que dará consistencia a la lámina y a la vez contribuirá a conseguir una mejor retención del elemento de sujeción hermética sobre el dispositivo. El último componente, el elemento complementario de hermeticidad puede o no incorporarse en el dispositivo, dependiendo del accesorio respiratorio, tanto del acoplador de mascarilla como del video laringoscopio, o del resto de componentes empleados como medios de retención herméticos. According to the above, the protection device could have a hermetic fastening element and / or a support plate and / or a complementary sealing element. The hermetic fastening element can be a piece that can be attached to the protection device or a piece that is part of the respiratory accessory itself, mask coupler or video laryngoscope, in the latter case in particular arranged on the handle or proximal end thereof. . Regardless of whether or not the protection device incorporates said hermetic fastening element (as mentioned, it may be incorporated in the respiratory accessory itself), the device may or may not incorporate a retention support plate, although preferably it incorporates it, which will give consistency. to the sheet and at the same time will help to achieve a better retention of the hermetic fastener on the device. The last component, the complementary sealing element, may or may not be incorporated into the device, depending on the respiratory accessory, both the mask coupler and the video laryngoscope, or the rest of the components used as hermetic retention means.
El elemento de sujeción hermética del accesorio respiratorio, acoplador de mascarilla o video laringoscopio puede tener diferentes construcciones y componentes, por ejemplo, entre otras construcciones posibles, puede comprender: una pieza tubular de material plástico, preferiblemente de ABS o similar, preferiblemente fabricada por inyección, y unida por su extremo superior a la superficie inferior de la lámina o de la placa soporte, coincidiendo el hueco del cuerpo tubular con el primer orificio de la lámina. En el hueco del cuerpo tubular, cuya sección del hueco es preferiblemente complementaria con la forma exterior del accesorio respiratorio, acoplador de mascarilla o mango o cuerpo del video laringoscopio, y en el que se introduce dicho accesorio respiratorio, presenta, preferiblemente, una junta interior en el perímetro del hueco, para mejorar la hermeticidad en la unión con el accesorio respiratorio, mientras que la forma exterior del cuerpo tubular no presenta ninguna limitación; y/ o una pieza tubular de material plástico en la que se introduce el accesorio respiratorio, similar a la anterior, pero que para conseguir el cierre hermético entre ambos se dispone una cinta elástica que es comprimida mediante el accionamiento de una leva; y/ o una pieza de material plástico con cuerpo tubular y en la que se introduce el accesorio respiratorio, donde el cuerpo tubular presenta en su hueco interior un material tipo goma o neopreno, que determina un hueco interior en la pieza que no es complementario con el del accesorio respiratorio, acoplador de mascarilla o cuerpo o mango del video laringoscopio. Dicha pieza con cuerpo tubular puede abrirse, mediante por ejemplo una articulación, para la introducción del accesorio respiratorio en su interior y posteriormente cerrarse para que el material del hueco interior se adapte a la forma del cuerpo exterior del accesorio respiratorio. Los medios de cierre pueden ser de diferente tipo como por ejemplo una brida o similar. Esta pieza de cuerpo tubular se une posteriormente a la lámina o a la placa soporte mediante por ejemplo una cinta adhesiva que garantice la hermeticidad entre el extremo superior de la pieza tubular y la superficie inferior de la lámina o placa soporte; y/o una pieza con un cuerpo anular de material elástico, unido o acoplado al perímetro de la primera abertura de la lámina o de la abertura de la placa soporte, y en el que se introduce de manera ajustada el accesorio respiratorio; y/ o Una cinta adhesiva adherida preferiblemente a la superficie inferior de la lámina o de la placa soporte y que se pueda adherir también al accesorio respiratorio, preferiblemente al acoplador de mascarilla o al mango del mismo, de manera que una parte de la cinta está adherida a la lámina y otra parte de la cinta se adhiere al accesorio respiratorio tras su introducción en el primer orificio, cerrando el hueco que pueda existir entre la lámina y el accesorio respiratorio y por lo tanto consiguiendo un cierre hermético en la unión entre dicha primera abertura y el accesorio respiratorio, acoplador de mascarilla o mango del video laringoscopio. The air-tight fastener of the breathing accessory, Mask or video laryngoscope can have different constructions and components, for example, among other possible constructions, it can comprise: a tubular piece of plastic material, preferably ABS or similar, preferably manufactured by injection, and joined at its upper end to the lower surface of the sheet or of the support plate, the hollow of the tubular body coinciding with the first hole in the sheet. In the hollow of the tubular body, whose section of the hollow is preferably complementary with the external shape of the respiratory accessory, mask coupler or handle or body of the video laryngoscope, and in which said respiratory accessory is inserted, it preferably has an interior gasket. in the perimeter of the hole, to improve the tightness in the union with the respiratory accessory, while the outer shape of the tubular body does not present any limitation; and / or a tubular piece of plastic material into which the respiratory accessory is inserted, similar to the previous one, but that to achieve the hermetic closure between both an elastic tape is arranged that is compressed by actuating a cam; and / or a piece of plastic material with a tubular body and into which the respiratory accessory is inserted, where the tubular body has a rubber or neoprene-like material in its interior hole, which determines an interior hole in the piece that is not complementary to that of the breathing accessory, mask coupler, or video laryngoscope body or handle. Said part with a tubular body can be opened, for example by means of a hinge, for the introduction of the respiratory accessory into its interior and subsequently closed so that the material of the interior hole adapts to the shape of the outer body of the respiratory accessory. The closing means can be of a different type, such as a flange or the like. This piece of tubular body is subsequently attached to the sheet or to the support plate by, for example, an adhesive tape that ensures airtightness between the upper end of the tubular piece and the lower surface of the sheet or support plate; and / or a piece with an annular body of elastic material, attached or coupled to the perimeter of the first opening of the sheet or of the opening of the support plate, and into which the respiratory accessory is inserted in a tight manner; and / or An adhesive tape preferably adhered to the lower surface of the sheet or the support plate and which can also be adhered to the respiratory accessory, preferably to the mask coupler or to the handle of the same, so that a part of the tape is adhered to the sheet and another part of the tape adheres to the respiratory accessory after its introduction in the first hole, closing the gap that may exist between the sheet and the respiratory accessory and therefore achieving a hermetic closure at the junction between said first opening and the respiratory accessory, mask coupler or handle of the video laryngoscope.
La unión entre cualquiera de los elementos de sujeción hermética anteriores y la lámina o la placa soporte puede realizarse de diferentes maneras, por ejemplo, mediante adhesivos entre ambos elementos (en el caso de las piezas tubulares, disponiendo el adhesivo entre el extremo superior de la pieza, que preferiblemente presenta una aleta perimetral, y la superficie inferior de las láminas), que puede estar combinados, o no, con salientes en el elemento de sujeción que se acoplan en orificios en la lámina; o introducción a presión del elemento de sujeción hermética en la lámina, preferiblemente en la placa soporte; o como se ha avanzado mediante el uso de cinta adhesiva. The union between any of the previous hermetic fastening elements and the sheet or the support plate can be carried out in different ways, for example, by means of adhesives between both elements (in the case of tubular pieces, placing the adhesive between the upper end of the part, which preferably has a perimeter fin, and the lower surface of the sheets), which may or may not be combined with projections on the fastening element that engage in holes in the sheet; or pressure introduction of the hermetic fastening element in the sheet, preferably in the support plate; or as progress has been made through the use of masking tape.
Un experto podrá combinar, si es necesario, algunos de los anteriores elementos de sujeción hermética del accesorio respiratorio en función de los requisitos del accesorio respiratorio o de las condiciones de la colocación de la mascarilla o intubación a realizar. Hay que tener en consideración que este elemento de sujeción hermética podría, dependiendo de la forma preferida de realización, integrarse en el propio accesorio respiratorio, por ejemplo, en el acoplador de mascarilla a la mascarilla o en el mango o extremo proximal del video laringoscopio. An expert will be able to combine, if necessary, some of the previous hermetic fasteners of the respiratory accessory depending on the requirements of the respiratory accessory or the conditions of the placement of the mask or intubation to be performed. It should be taken into account that this hermetic fastening element could, depending on the preferred embodiment, be integrated into the respiratory accessory itself, for example, in the mask-to-mask coupler or in the handle or proximal end of the video laryngoscope.
Los medios de retención podrán estar convenientemente particularizados, según el accesorio respiratorio al que se destine el dispositivo, tipo de acoplador de mascarilla o modelo de video laringoscopio, para garantizar su sujeción y la hermeticidad o estanqueidad en la unión entre ambos, por lo que preferiblemente los medios de retención herméticos comprenden un cuerpo tubular cuyo interior es complementario al cuerpo del accesorio respiratorio que se introduce en dicho cuerpo tubular y su exterior es complementario a la primera abertura. The retention means may be suitably particularized, depending on the respiratory accessory to which the device is intended, type of mask coupler or video laryngoscope model, to guarantee its hold and the hermeticity or watertightness in the union between both, so preferably the hermetic retention means comprise a tubular body whose interior is complementary to the body of the respiratory accessory that is inserted into said tubular body and its exterior is complementary to the first opening.
Preferiblemente, las dimensiones de la lámina deben ser tales que cubren al menos la cabeza o cara del paciente, aunque preferiblemente se extienden también hasta cubrir el tórax de este. La lámina puede tener diferentes formas, como, por ejemplo, circular, cuadrada o rectangular con las esquinas redondeadas, rectangular con dos disminuciones de la anchura en la zona donde se ubica el accesorio respiratorio para facilitar la introducción de los brazos del profesional o intubador por debajo de la lámina de cara a la manipulación del laringoscopio, e incluso dos aberturas laterales para la introducción de los brazos del profesional o intubador desde el lado superior al lado inferior. Estas aberturas permitirán la introducción de los brazos de una manera ajustada (por ejemplo, cortes en la lámina o aberturas con capas solapadas de un material flexible que permiten la introducción del brazo, etc.) para mantener separados el espacio por encima de la lámina, lado limpio, del espacio por debajo de la misma, lado sucio. Alternativamente, las aberturas pueden ser aproximadamente circulares y disponer por la superficie inferior, unida a cada una, por medio de un adhesivo o por termo soldadura, de un manguito tubular de material plástico también, que por el extremo contrario al de unión a la lámina, presentan un elemento elástico que disminuye su diámetro, de manera que, al introducir las manos del profesional, cada manguito queda perfectamente ajustado sobre la muñeca o brazo, asegurando así la hermeticidad o estanqueidad. El material plástico de estos manguitos es preferiblemente PVC o un plástico de grado médico, que es transparente, y con un espesor preferiblemente de entre 30 pm y 100 pm, más preferiblemente 50 pm. Preferably, the dimensions of the sheet should be such that they cover at least the head or face of the patient, although preferably they also extend to cover the chest of the patient. The sheet can have different shapes, such as, for example, circular, square or rectangular with rounded corners, rectangular with two decreases in width in the area where the respiratory accessory is located to facilitate the introduction of the arms of the professional or intubator under the blade for the manipulation of the laryngoscope, and even two lateral openings for the introduction of the arms of the professional or intubator from the upper side to the lower side. These openings will allow the introduction of the arms in a tight manner (for example, cuts in the sheet or openings with overlapping layers of a flexible material that allow the introduction of the arm, etc.) to keep the space above the sheet separate, clean side, of the space below it, dirty side. Alternatively, the openings can be approximately circular and have on the lower surface, joined to each one, by means of an adhesive or by heat welding, a tubular sleeve of plastic material also, which at the opposite end to the one joining the sheet , have an elastic element that decreases its diameter, so that, when the professional's hands are inserted, each cuff is perfectly adjusted on the wrist or arm, thus ensuring hermeticity or watertightness. The plastic material of these sleeves is preferably PVC or a medical grade plastic, which is transparent, and with a thickness preferably between 30 pm and 100 pm, more preferably 50 pm.
El dispositivo de protección además puede incorporar en la superficie superior de la lámina unas cintas adhesivas u otro elemento equivalente, por ejemplo, unas cuerdas, que sirven para poder sujetar la lámina a elementos de sujeción ajenos al dispositivo de protección, por ejemplo, unos alambres o cables dispuestos sobre las camas de hospital. The protection device can also incorporate adhesive tapes or other equivalent elements on the upper surface of the sheet, for example, ropes, which serve to be able to fasten the sheet to fastening elements other than the protection device, for example, wires. or cables arranged over hospital beds.
La lámina es flexible, con un espesor preferiblemente de entre 20 pm y 80 pm, más preferiblemente 50 pm, y preferiblemente de un material plástico, preferiblemente PVC o un plástico de grado médico, que además es transparente para que el profesional o persona que realiza la intubación pueda ver a través de la lámina para colocar correctamente el accesorio respiratorio y colocar la mascarilla y/o introducir el tubo endotraqueal. La flexibilidad de la lámina permite que pueda ser doblada para su plegado, por ejemplo, para el embalaje y/o para adoptar la forma adecuada para cubrir al paciente. The sheet is flexible, with a thickness preferably between 20 pm and 80 pm, more preferably 50 pm, and preferably of a plastic material, preferably PVC or a medical grade plastic, which is also transparent for the professional or person who performs. intubation can see through the foil to correctly position the breathing accessory and place the mask and / or insert the endotracheal tube. The flexibility of the sheet allows it to be folded for folding, for example, for packaging and / or to adopt a suitable shape to cover the patient.
Preferiblemente, si el dispositivo de protección va a ser empleado para una intubación, y para que sea efectivo en los casos en los que el video laringoscopio integra un canal para guiar el tubo endotraqueal, y por lo tanto, al inicio de la intubación, el extremo proximal del tubo endotraqueal sobresale del extremo proximal del mango del video laringoscopio, por lo que la lámina comprende una segunda abertura que es adyacente a la primera abertura y presenta, unida a dicha segunda abertura, un contenedor o bolsa, para recibir dicho extremo proximal del tubo. La única embocadura del contenedor o bolsa queda unida al perímetro de la segunda abertura preferiblemente por un adhesivo o por termo soldadura. Dicha bolsa o contenedor se une a la superficie superior de la lámina y su objetivo es recibir al menos el tubo endotraqueal empleado para la intubación que puede o no incorporar un elemento de guía en su interior. El tubo endotraqueal se introduce por la parte inferior de la lámina en la bolsa, o contenedor, simultáneamente a la introducción del video laringoscopio en la primera abertura. Durante y después de la intubación el intubador podrá manipular el tubo desde la parte inferior de la lámina con una mano mientras sujeta con la otra el video laringoscopio. Dicha bolsa o contenedor es también preferiblemente de un material plástico, preferiblemente PVC o un plástico de grado médico, también transparente, y con un espesor preferiblemente de entre 30 pm y 100 pm, más preferiblemente 50 pm. Preferably, if the protection device is to be used for intubation, and to be effective in cases where the video laryngoscope integrates a channel to guide the endotracheal tube, and therefore, at the beginning of intubation, the proximal end of the endotracheal tube protrudes from the proximal end of the handle of the video laryngoscope, whereby the blade comprises a second opening that is adjacent to the first opening and has, attached to said second opening, a container or bag, for receiving said proximal end of the tube. The only mouth of the container or bag is attached to the perimeter of the second opening preferably by an adhesive or by heat welding. Said bag or container is attached to the upper surface of the sheet and its objective is to receive at least the endotracheal tube used for intubation, which may or may not incorporate a guide element inside it. The endotracheal tube is inserted through the lower part of the sheet into the bag, or container, simultaneously with the introduction of the video laryngoscope in the first opening. During and after intubation, the intubator can manipulate the tube from the underside of the lamina with one hand while holding the video laryngoscope with the other. Said bag or container is also preferably made of a plastic material, preferably PVC or a medical grade plastic, also transparent, and with a thickness preferably between 30 pm and 100 pm, more preferably 50 pm.
Como se ha mencionado anteriormente, un posible componente de los medios de retención herméticos del dispositivo es una placa soporte de refuerzo unida, preferiblemente, a la superficie inferior de la lámina. La placa soporte de refuerzo presenta una abertura coincidente con la primera abertura de dicha lámina para permitir también la unión del elemento de sujeción hermética a dicha primera abertura, quedando dicho elemento de sujeción hermética ajustado a la abertura de dicha placa soporte de refuerzo, pero en este supuesto en lugar de unirse a la superficie inferior de la lámina, los medios de retención se unen a la placa soporte, que a su vez queda unida a la lámina como se ha mencionado anteriormente. El objetivo de esta placa soporte es, además de dar consistencia a la unión entre el elemento de sujeción hermética y la lámina, crear un techo sobre la cabeza del paciente durante la colocación de la mascarilla o de la intubación para impedir en la mayor medida posible que la lámina entre en contacto directo con la cara del paciente y evitar incomodidades para el paciente en caso de que se encuentre consciente durante el proceso anterior, colocación de mascarilla o intubación. Mediante esta placa soporte se crea un espacio por encima de la cara del paciente que permite manipular el accesorio respiratorio con precisión. As mentioned above, a possible component of the hermetic retention means of the device is a reinforcing support plate attached, preferably, to the lower surface of the sheet. The reinforcement support plate has an opening coinciding with the first opening of said sheet to also allow the attachment of the hermetic fastening element to said first opening, said hermetic fastening element being adjusted to the opening of said reinforcing support plate, but in In this case, instead of being attached to the lower surface of the sheet, the retention means are attached to the support plate, which in turn remains attached to the sheet as mentioned above. The objective of this support plate is, in addition to giving consistency to the union between the hermetic clamping element and the sheet, to create a ceiling over the patient's head during the placement of the mask or intubation to prevent as much as possible that the sheet comes into direct contact with the patient's face and avoid discomfort for the patient if he is conscious during the previous process, mask placement or intubation. This support plate creates a space above the patient's face that allows the breathing accessory to be manipulated with precision.
Dicha placa soporte de refuerzo puede tener diferentes configuraciones, por ejemplo, circular, elíptica, cuadrada o rectangular con sus vértices redondeados para evitar dañar la lámina a la que queda unida. Asimismo, si la lámina comprende una segunda abertura, la placa soporte preferiblemente presentará un entrante que coincidirá con dicha segunda abertura para poder acceder a la bolsa o contenedor del tubo endotraqueal. Asimismo, ese entrante facilita la manipulación del tubo endotraqueal desde el lado inferior de la lámina. La abertura de la placa soporte coincidente con la primera abertura de la lámina, a través de las cuales se introduce el accesorio respiratorio, se dispone adyacente al lado de la placa soporte de refuerzo que se aproxima más al tórax del paciente durante la introducción del accesorio respiratorio, especialmente durante la introducción del video laringoscopio con el fin de que no dificulte la introducción de la parte distal del video laringoscopio en la boca del paciente. Said reinforcement support plate can have different configurations, for example, circular, elliptical, square or rectangular with rounded corners to avoid damaging the sheet to which it is attached. Likewise, if the sheet comprises a second opening, the support plate will preferably have a recess that it will coincide with said second opening to be able to access the bag or container of the endotracheal tube. Also, this recess facilitates the manipulation of the endotracheal tube from the lower side of the sheet. The opening of the support plate coinciding with the first opening of the sheet, through which the respiratory accessory is introduced, is arranged adjacent to the side of the reinforcing support plate that is closest to the patient's chest during insertion of the accessory. respiratory tract, especially during the introduction of the video laryngoscope in order not to hinder the introduction of the distal part of the video laryngoscope into the patient's mouth.
Preferiblemente la placa soporte es de un material plástico, más rígido que los anteriores, y preferiblemente también de PVC o un plástico de grado médico, y también transparente, con un espesor preferiblemente de entre 1 ,5 mm y 3 mm, más preferiblemente 2 mm. Preferably the support plate is made of a plastic material, more rigid than the previous ones, and preferably also made of PVC or a medical grade plastic, and also transparent, with a thickness preferably between 1.5 mm and 3 mm, more preferably 2 mm .
La superficie de la placa soporte y el eje vertical del elemento de sujeción hermética preferiblemente presentan un ángulo entre ambos que es menor de 90° y mayor de 70°. El motivo de esa inclinación del elemento de sujeción respecto a la placa soporte, y la lámina, es facilitar la introducción del accesorio respiratorio en la boca del paciente, especialmente cuando se trata de un video laringoscopio debido a su longitud y a la curva que es necesario hacer para su introducción en la boca, para evitar que el accesorio golpee en el tórax del paciente. The surface of the support plate and the vertical axis of the sealing fastener preferably have an angle between them that is less than 90 ° and greater than 70 °. The reason for this inclination of the clamping element with respect to the support plate, and the sheet, is to facilitate the introduction of the respiratory accessory into the patient's mouth, especially when it is a video laryngoscope due to its length and the curve that is necessary. do for its introduction in the mouth, to avoid that the accessory hits the chest of the patient.
Otro posible componente de los medios de retención herméticos es el citado elemento complementario de hermeticidad para reforzar la hermeticidad entre el elemento de sujeción hermética y la lámina o la placa soporte, dependiendo de si el dispositivo de protección comprende o no dicha placa soporte. Este elemento complementario de hermeticidad se dispone en la superficie superior de la lámina para reforzar, por el lado superior de la lámina, la hermeticidad entre la superficie superior de dicha lámina y/o el elemento de sujeción hermética y/o el accesorio respiratorio, acoplador de mascarilla o mango del video laringoscopio. Este elemento complementario de hermeticidad, preferiblemente será una cubierta, aunque también puede ser una cinta adhesiva, o ambas, dependiendo del tipo de accesorio respiratorio a utilizar con el dispositivo de protección. Another possible component of the hermetic retention means is said complementary sealing element to reinforce the seal between the hermetic fastening element and the sheet or the support plate, depending on whether or not the protection device comprises said support plate. This complementary sealing element is arranged on the upper surface of the sheet to reinforce, on the upper side of the sheet, the seal between the upper surface of said sheet and / or the hermetic fastening element and / or the respiratory accessory, coupler mask or video laryngoscope handle. This complementary sealing element will preferably be a cover, although it can also be an adhesive tape, or both, depending on the type of respiratory accessory to be used with the protection device.
Como ya se ha mencionado, el accesorio respiratorio puede ser un video laringoscopio, y dentro de estos puede ser uno de cualquiera de los tipos conocidos. Por ejemplo, un video laringoscopio tipo Airtraq© o similar, que se distingue porque se visualiza la imagen a través de un visor en su extremo proximal o una cámara conectada en el visor y porque incorpora un canal donde se aloja el tubo endotraqueal; o un video laringoscopio tipo Glysdescope© que se distingue porque se visualiza la imagen a través de una pantalla separada del mango a la que llega la imagen a través de un cable conectado a dicho mango y porque no tiene un canal donde se aloja el tubo endotraqueal; o un video laringoscopio tipo McGrath©, cuya característica principal es que se visualiza la imagen a través de una pantalla integrada en el mango y porque no tiene un canal donde se aloja el tubo endotraqueal. As already mentioned, the respiratory accessory can be a video laryngoscope, and within these it can be one of any of the known types. For example, a video laryngoscope type Airtraq © or similar, which is distinguished because the image is viewed through a viewfinder at its proximal end or a connected camera in the viewer and because it incorporates a channel where the endotracheal tube is housed; or a video laryngoscope type Glysdescope © that is distinguished by the fact that the image is viewed through a screen separate from the handle to which the image arrives through a cable connected to said handle and because it does not have a channel where the endotracheal tube is housed ; or a McGrath © type video laryngoscope, whose main characteristic is that the image is viewed through a screen integrated in the handle and because it does not have a channel where the endotracheal tube is housed.
En el caso concreto de video laringoscopios, como accesorios respiratorios en los que la imagen se ve a través de un visor en el extremo distal del video laringoscopio, por ejemplo, estilo Airtraq© u otros, y con el fin de asegurar la hermeticidad de la conexión entre el video laringoscopio, el elemento de sujeción hermética y la lámina, se dispone sobre la superficie superior de esta la citada cubierta, que va unida a dicha superficie superior de la lámina. Dicha cubierta permite la conexión de una cámara con este tipo de video laringoscopio sobre el extremo proximal del mango y presenta una abertura superior y otra inferior para la transmisión de la imagen que proviene del extremo distal del video laringoscopio hasta el exterior del mismo. Esta cubierta es preferiblemente de un material plástico, preferiblemente PVC o plástico de grado médico, y también transparente, con un espesor preferiblemente de entre 5 pm y 35 pm, más preferiblemente 20 pm. La cubierta preferiblemente presenta para su unión hermética a la lámina, un resalte inferior que se introduce en el interior del primer orificio, entre dicho orificio y el elemento de sujeción hermético o el video laringoscopio, y una aleta lateral que se dispone, preferiblemente mediante adhesión, sobre la superficie superior de la lámina, contribuyendo así a evitar que la contaminación pueda pasar desde el lado inferior de la lámina hacia el lado superior y viceversa. Alternativamente a dicha cubierta, se podrá disponer una cinta adhesiva en torno al primer orificio de manera que se una de manera hermética la superficie superior de la lámina con el video laringoscopio. In the specific case of video laryngoscopes, such as respiratory accessories in which the image is seen through a viewer at the distal end of the video laryngoscope, for example, Airtraq © style or others, and in order to ensure the hermeticity of the connection between the video laryngoscope, the hermetic clamping element and the sheet, said cover is arranged on the upper surface of the latter, which is attached to said upper surface of the sheet. Said cover allows the connection of a camera with this type of video laryngoscope on the proximal end of the handle and has an upper and a lower opening for the transmission of the image that comes from the distal end of the video laryngoscope to the outside of it. This cover is preferably made of a plastic material, preferably PVC or medical grade plastic, and also transparent, with a thickness preferably between 5 pm and 35 pm, more preferably 20 pm. The cover preferably has, for its hermetic connection to the sheet, a lower projection that is inserted inside the first hole, between said hole and the hermetic fastening element or the video laryngoscope, and a lateral flap that is arranged, preferably by adhesion , on the upper surface of the sheet, thus helping to prevent contamination from passing from the lower side of the sheet to the upper side and vice versa. As an alternative to said cover, an adhesive tape may be arranged around the first hole so as to hermetically join the upper surface of the sheet with the video laryngoscope.
En el caso concreto de los video laringoscopios, en particular aquellos en los que la imagen se ve a través de un visor en el extremo distal del video laringoscopio, estilo Airtraq© u otros, el mango del video laringoscopio se introducirá en la primera abertura por la parte inferior de la lámina quedando unida a esta a través de los medios de retención herméticos. Por la superficie superior se dispone la cubierta que contribuye a garantizar la hermeticidad entre el laringoscopio o video laringoscopio y la lámina. Sobre dicha cubierta se acoplará el sistema de visión, preferiblemente una cámara o medios de transmisión de la imagen a un monitor, que ayudará al intubador a la introducción del tubo endotraqueal en el paciente. In the specific case of video laryngoscopes, particularly those in which the image is viewed through a viewfinder at the distal end of the video laryngoscope, Airtraq © style or others, the handle of the video laryngoscope will be inserted into the first opening through the lower part of the sheet being attached to it through the hermetic retention means. On the upper surface there is a cover that helps to guarantee the tightness between the laryngoscope or video laryngoscope and the sheet. On said cover the vision system will be attached, preferably a camera or media transmission of the image to a monitor, which will assist the intubator in introducing the endotracheal tube into the patient.
En otros tipos de video laringoscopios, como por ejemplo tipo Glydescope© o tipo McGrath©, con un cable que sale del mango del video laringoscopio o una pantalla solidaria con el mango del video laringoscopio, el video laringoscopio se podrá introducir en el primer orificio por el lado superior de la lámina. In other types of video laryngoscopes, such as the Glydescope © type or the McGrath © type, with a cable coming out of the video laryngoscope handle or a screen attached to the video laryngoscope handle, the video laryngoscope can be inserted into the first hole through the top side of the sheet.
Posteriormente, se puede proceder a la intubación del paciente. Para ello, el profesional o intubador cogerá con las manos el video laringoscopio por la parte inferior de la lámina o lado sucio, manteniendo su cabeza por la parte superior de la misma o lado limpio, de manera que ambas cabezas, la del intubador y la del paciente intubado, se encuentren separadas por la lámina, pero las manos del intubador estén en el lado inferior sin interferencia de la lámina. Durante la intubación se introduce el tubo endotraqueal en el paciente. En el caso concreto de los video laringoscopios que integran un canal para guiar el tubo endotraqueal, estilo Airtraq© u otros, el extremo distal del tubo endotraqueal se encuentra en el canal del video laringoscopio y el extremo proximal alojado en la bolsa o contenedor del dispositivo objeto de la invención, de manera que durante la intubación el intubador puede con una mano deslizar el tubo endotraqueal hacia el interior del paciente, en concreto hacia la tráquea, mientras que con la otra mano sujeta el video laringoscopio. Subsequently, the patient can be intubated. To do this, the professional or intubator will hold the video laryngoscope by the lower part of the film or dirty side with his hands, keeping his head on the upper part of it or clean side, so that both heads, that of the intubator and the of the intubated patient are separated by the blade, but the hands of the intubator are on the underside without interference from the blade. During intubation, the endotracheal tube is introduced into the patient. In the specific case of video laryngoscopes that include a channel to guide the endotracheal tube, Airtraq © style or others, the distal end of the endotracheal tube is located in the channel of the video laryngoscope and the proximal end housed in the bag or container of the device object of the invention, so that during intubation the intubator can slide the endotracheal tube into the patient with one hand, specifically towards the trachea, while holding the video laryngoscope with the other hand.
En el caso de los video laringoscopios sin canal para guiar el tubo endotraqueal, dicho tubo endotraqueal se encuentra durante la intubación en la mano del intubador y por debajo de la lámina, no siendo necesario que el dispositivo protector objeto de la invención comprenda la bolsa o contenedor citado anteriormente. In the case of video laryngoscopes without a channel to guide the endotracheal tube, said endotracheal tube is located during intubation in the hand of the intubator and below the sheet, it is not necessary for the protective device object of the invention to comprise the bag or container cited above.
Una vez introducido el tubo endotraqueal, a través de las cuerdas vocales, se retira el video laringoscopio de la boca junto a la lámina, manteniendo el tubo endotraqueal en el paciente. Un ayudante del intubador, que no haya estado en contacto con el lado sucio situado por debajo del dispositivo protector, podrá retirar la cámara del laringoscopio o desconectar los cables del video laringoscopio que siempre han permanecido aislados del paciente, y por la tanto no han sido contaminados, para su posterior reutilización. Once the endotracheal tube has been introduced, through the vocal cords, the video laryngoscope is withdrawn from the mouth next to the sheet, keeping the endotracheal tube in the patient. An intubator assistant, who has not been in contact with the dirty side below the protective device, can remove the camera from the laryngoscope or disconnect the cables from the video laryngoscope that have always remained isolated from the patient, and therefore have not been contaminated, for later reuse.
En el caso de utilizar el dispositivo de protección objeto de la invención con una mascarilla, o casco, como accesorio respiratorio, será necesario emplear un acoplador de mascarilla que preferiblemente presentará un cuerpo hueco y que al menos comprenderá: Un primer orificio para la salida de aire dispuesto en su extremo inferior o extremo distal para ser acoplado a la mascarilla facial o casco que se dispondrá sobre la cara del paciente, In the case of using the protection device object of the invention with a mask, or helmet, as a respiratory accessory, it will be necessary to use a mask coupler that preferably will have a hollow body and that will at least comprise: A first hole for the outlet of air arranged at its lower end or distal end to be coupled to the face mask or helmet that will be arranged on the patient's face,
Un saliente de acoplamiento en su extremo superior o extremo proximal para ser acoplado al dispositivo de protección a través de la primera abertura de la lámina mediante unos medios de protección herméticos, y A coupling projection at its upper end or proximal end to be coupled to the protection device through the first opening of the sheet by means of a hermetic protection means, and
Un segundo orificio para la entrada de aire, desde un respirador, que está dispuesto entre el primer orificio y el saliente de acoplamiento. A second port for the inlet of air, from a respirator, which is arranged between the first port and the coupling projection.
El acoplador de mascarilla por lo tanto se conecta con la mascarilla, o casco, a través del primer orificio para, posteriormente, conectarse con la primera abertura del dispositivo desde la superficie inferior de la lámina, empleando los medios de retención herméticos correspondientes. El acoplador se conecta también con un respirador, habitualmente manual, y accionado por el profesional desde el lado sucio, es decir, por debajo de la lámina. El profesional, por lo tanto, mantiene una mano sobre la mascarilla o casco sobre el paciente y con la otra puede accionar el respirador manual. The mask coupler therefore connects to the mask, or helmet, through the first hole to subsequently connect to the first opening of the device from the lower surface of the sheet, using the corresponding airtight retention means. The coupler is also connected to a respirator, usually manual, and operated by the professional from the dirty side, that is, below the sheet. The professional, therefore, keeps one hand on the mask or helmet on the patient and with the other can operate the manual respirator.
Respecto a la lámina y sus componentes, así como al accesorio respiratorio, acoplador de mascarilla, y el video laringoscopio acoplado a la lámina, pueden ser reutilizados tras su desinfección y esterilización por cualquiera de los medios conocidos si los materiales de los distintos componentes lo permiten, o bien, pueden ser directamente desechados. Regarding the sheet and its components, as well as the respiratory accessory, mask coupler, and the video laryngoscope attached to the sheet, they can be reused after disinfection and sterilization by any of the known means if the materials of the different components allow it. , or they can be directly discarded.
Otros objetos de la presente invención también son un sistema para intubaciones, conformado por un video laringoscopio y un dispositivo de protección conforme a cualquiera de las opciones descritas anteriormente, y un método de manipulación del dispositivo de protección descrito anteriormente. Other objects of the present invention are also a system for intubations, made up of a video laryngoscope and a protection device according to any of the options described above, and a method of manipulating the protection device described above.
El sistema para procesos que requiera contacto con la vía aérea superior de un paciente comprenderá: The system for processes that require contact with the upper airway of a patient will include:
Un dispositivo según cualquiera de las alternativas anteriormente descritas, y Un accesorio respiratorio acoplado al primer orificio de dicho dispositivo. A device according to any of the alternatives described above, and A respiratory accessory coupled to the first hole of said device.
Como ya se ha mencionado, el accesorio respiratorio podrá ser un acoplador de mascarilla, un video laringoscopio con o sin canal de guía para el tubo endotraqueal, con la pantalla integrada en el mango del video laringoscopio, o una pantalla acoplable al visor o al mango del video laringoscopio, o con la pantalla separada del video laringoscopio y unida por cables a este. As already mentioned, the respiratory accessory may be a mask coupler, a video laryngoscope with or without a guide channel for the endotracheal tube, with the screen integrated in the handle of the video laryngoscope, or a screen that can be attached to the viewfinder or the handle. video laryngoscope, or with the screen separated from the video laryngoscope and attached by cables to it.
El método de manipulación del dispositivo de protección comprende al menos las siguientes etapas: a) Introducción por parte de un profesional médico del accesorio respiratorio en el primer oficio de la lámina por la parte inferior o por la parte superior de la misma y asegurar su hermeticidad. En el caso del acoplador de mascarilla se introducirá por la parte inferior, mientras que en el caso de un video laringoscopio, se introducirá el mango, o extremo proximal, del mismo en la primera abertura, por la parte inferior de la lámina o por la parte superior de la misma, dependiendo del tipo de video laringoscopio. Los medios de retención herméticos del dispositivo se emplearán para asegurar el acoplamiento hermético entre la lámina y el accesorio respiratorio. b) Sujeción con las manos del profesional médico del accesorio respiratorio por la parte inferior de la lámina a la vez que se mantiene la cabeza del profesional por la parte superior de la misma. The method of handling the protection device comprises at least the following stages: a) Introduction by a medical professional of the respiratory accessory in the first job of the sheet from the bottom or top of it and ensure its tightness. In the case of the mask coupler, it will be inserted through the lower part, while in the case of a video laryngoscope, the handle, or proximal end, of the same will be inserted in the first opening, through the lower part of the sheet or through the top of it, depending on the type of video laryngoscope. The hermetic retention means of the device will be used to ensure the hermetic coupling between the foil and the breathing accessory. b) Holding the respiratory accessory with the hands of the medical professional by the lower part of the sheet while keeping the professional's head on the upper part of it.
En el caso de que el accesorio respiratorio sea un video laringoscopio, el profesional lo sujetará con sus manos por el extremo distal del mango o video laringoscopio, por debajo de la lámina, y posteriormente procederá a la introducción del extremo distal del laringoscopio o video laringoscopio, por la boca del paciente, y posterior manipulación del tubo endotraqueal para su introducción a través de las cuerdas vocales del paciente, manteniendo las manos del profesional médico, o intubador, por la parte inferior de la lámina y su cabeza separada por la parte superior de la lámina del dispositivo. In the event that the respiratory accessory is a video laryngoscope, the professional will hold it with his hands by the distal end of the handle or video laryngoscope, below the blade, and then proceed to the introduction of the distal end of the laryngoscope or video laryngoscope , through the patient's mouth, and subsequent manipulation of the endotracheal tube for its introduction through the vocal cords of the patient, keeping the hands of the medical professional, or intubator, by the lower part of the blade and his head separated by the upper part of the device sheet.
En el caso de que el accesorio respiratorio sea un acoplador de mascarilla, el profesional médico, además de conectar el acoplador al dispositivo, deberá conectar, o haber conectado previamente la mascarilla y el respirador a dicho acoplador. De esta manera, y siempre operando por la parte inferior de la lámina, o lado sucio, el profesional podrá sujetar con una mano la mascarilla sobre el paciente y con la otra mano accionar el respirado cuando este sea manual. In the event that the respiratory accessory is a mask coupler, the medical professional, in addition to connecting the coupler to the device, must connect, or have previously connected the mask and respirator to said coupler. In this way, and always operating from the lower part of the sheet, or dirty side, the professional will be able to hold the mask on the patient with one hand and with the other hand to activate the breathing when it is manual.
Conforme a lo anterior, el dispositivo de protección de la invención puede emplearse de manera consecutiva sobre un paciente con diferentes accesorios respiratorios. En un primer lugar se podría utilizar el dispositivo de protección con un acoplador de mascarilla, para la cual se conectaría al mismo la mascarilla conectada al respirador y posteriormente el conjunto se acoplaría al dispositivo de protección. Una vez acoplado el conjunto se dispone el dispositivo sobre el paciente, en particular sobre la boca y la nariz, y se le suministra el oxígeno proporcionando así ventilación asistida al paciente y manteniendo al paciente separado del profesional médico para evitar posibles contagios. In accordance with the foregoing, the protection device of the invention can be used consecutively on a patient with different respiratory accessories. In the first place, the protection device could be used with a mask coupler, for which the mask connected to the respirator would be connected to it and later the assembly would be coupled to the protection device. Once the assembly is attached, the device is placed on the patient, in particular on the mouth and nose, and oxygen is supplied, thus providing assisted ventilation. to the patient and keeping the patient separate from the medical professional to avoid possible contagion.
Posteriormente, se podría retirar desde la parte inferior de la lámina del dispositivo de protección la mascarilla y el acoplador e insertar en dicho dispositivo el video laringoscopio para proceder a la introducción del video laringoscopio en el paciente manteniendo la separación entre este y el profesional médico. Tras la introducción del video laringoscopio y la correspondiente conexión de los medios de visualización, el profesional médico procede a la intubación del paciente empujando el tubo endotraqueal en el interior del paciente y siguiendo su trayectoria con los medios de visualización del laringoscopio. Subsequently, the mask and coupler could be removed from the lower part of the sheet of the protection device and the video laryngoscope could be inserted into said device to proceed with the introduction of the video laryngoscope into the patient, maintaining the separation between the patient and the medical professional. After the introduction of the video laryngoscope and the corresponding connection of the visualization means, the medical professional proceeds to intubation the patient by pushing the endotracheal tube inside the patient and following its trajectory with the visualization means of the laryngoscope.
DESCRIPCIÓN DE LOS DIBUJOS DESCRIPTION OF THE DRAWINGS
Para completar la descripción de la presente invención y con el fin de facilitar la comprensión de las características de la presente invención, se incluye en la presente memoria descriptiva, como parte integrante de la misma, un juego de figuras con carácter ilustrativo y no limitativo. To complete the description of the present invention and in order to facilitate the understanding of the characteristics of the present invention, a set of figures with an illustrative and non-limiting character is included in the present specification, as an integral part thereof.
La figura número 1 muestra una vista en perspectiva superior del dispositivo protector objeto de la invención y una ampliación de un detalle de unos medios de retención herméticos para un video laringoscopio en el dispositivo de protección. Figure number 1 shows a top perspective view of the protective device object of the invention and an enlargement of a detail of a hermetic retention means for a video laryngoscope in the protection device.
La figura número 2 muestra los elementos de la invención, una lámina con dos aberturas y una bolsa o contenedor previamente a ser unida a una de dichas aberturas. Figure number 2 shows the elements of the invention, a sheet with two openings and a bag or container before being attached to one of said openings.
La figura número 3 muestra unos medios de retención herméticos del dispositivo de la invención en proceso de montaje a una placa soporte de refuerzo unida a la lámina del dispositivo. Figure number 3 shows a hermetic retention means of the device of the invention in the process of being assembled to a reinforcing support plate attached to the sheet of the device.
La figura número 4 muestra los medios de retención herméticos de la figura 3 con una cubierta de dichos medios previamente a su montaje. Figure number 4 shows the hermetic retention means of figure 3 with a cover of said means prior to their assembly.
La figura número 5 muestra la instalación de los medios de retención herméticos en una lámina con la bolsa o contenedor incorporado. Figure number 5 shows the installation of the hermetic retention means in a sheet with the bag or container incorporated.
La figura número 6A muestra un dispositivo de protección, objeto de la invención, sin bolsa o contenedor, con un video laringoscopio acoplado a la lámina, siendo el video laringoscopio del tipo Glydescope© o similar, sin canal para tubo endotraqueal ni pantalla integrada, disponiendo un cable que conecta el mango del laringoscopio con un sistema de visión y/o alimentación eléctrica. Figure 6A shows a protection device, object of the invention, without a bag or container, with a video laryngoscope attached to the sheet, the video laryngoscope being of the Glydescope © type or similar, without an endotracheal tube channel or integrated screen, having a cable that connects the laryngoscope handle to a vision and / or power supply system.
La figura número 6B muestra un dispositivo de protección, objeto de la invención, sin bolsa o contenedor, con un video laringoscopio acoplado a la lámina, siendo el video laringoscopio del tipo McGrath© o similar, sin canal para tubo endotraqueal, pero con una pantalla incorporada en su mango. Figure number 6B shows a protection device, object of the invention, without bag or container, with a video laryngoscope attached to the sheet, the video laryngoscope being of the McGrath © type or similar, without a channel for an endotracheal tube, but with a screen incorporated into its handle.
La figura número 6C muestra un dispositivo de protección, objeto de la invención, con bolsa o contenedor para el tubo endotraqueal, con un video laringoscopio acoplado a la lámina, siendo el video laringoscopio del tipo Airtraq© o similar, con canal para tubo endotraqueal y con un visor en el extremo proximal del mango al que se le puede acoplar una pantalla, observándose como el extremo del tubo endotraqueal se encuentra introducido en la bolsa o contenedor. Figure 6C shows a protection device, object of the invention, with a bag or container for the endotracheal tube, with a video laryngoscope attached to the sheet, the video laryngoscope being of the Airtraq © type or similar, with a channel for the endotracheal tube and with a viewer at the proximal end of the handle to which a screen can be attached, observing how the end of the endotracheal tube is inserted into the bag or container.
La figura 7 muestra la solución de la figura 6C con el video laringoscopio introducido en un paciente, observándose cómo la lámina cubre la cabeza del paciente, como los brazos operan por la parte inferior de la lámina, una mano sujetando el video laringoscopio y otra el tubo endotraqueal, con el extremo proximal del tubo endotraqueal introducido en la bolsa o guía. La cabeza del intubador se sitúa por encima de la lámina, separada de la cabeza de la paciente, enfrentada a la pantalla para poder realizar la intubación. Figure 7 shows the solution of Figure 6C with the video laryngoscope inserted into a patient, observing how the sheet covers the patient's head, how the arms operate through the lower part of the sheet, one hand holding the video laryngoscope and the other the endotracheal tube, with the proximal end of the endotracheal tube inserted into the bag or guide. The head of the intubator is positioned above the lamina, separated from the head of the patient, facing the screen to allow intubation.
La figura 8 muestra un dispositivo según la presente invención con un video laringoscopio del tipo mostrado en las figuras 6C y 7 previamente a su intubación y sin la pantalla conectada. Figure 8 shows a device according to the present invention with a video laryngoscope of the type shown in Figures 6C and 7 prior to intubation and without the screen connected.
La figura 9 muestra una sección A-B del dispositivo con un video laringoscopio (sin seccionar) conforme a la figura 8. Figure 9 shows a section A-B of the device with a video laryngoscope (not sectioned) according to figure 8.
La figura 10 muestra una vista en perspectiva de un dispositivo de protección conforme a la presente invención con dos bolsas tubulares para la introducción de los brazos y del profesional desde el lado limpio al lado sucio. Figure 10 shows a perspective view of a protection device according to the present invention with two tubular bags for the introduction of the arms and the professional from the clean side to the dirty side.
Las figuras 11A y 11 B muestra dos vistas en perspectiva de un acoplador de mascarilla. Figures 11A and 11B show two perspective views of a mask coupler.
La figura 12 muestra una sección CD de la figura 10. Figure 12 shows a section CD of Figure 10.
Las figuras 13 y 14 muestran dos vistas en perspectiva de un acoplador de mascarilla conectado al dispositivo de protección. Figures 13 and 14 show two perspective views of a mask coupler connected to the protection device.
La figura 15 muestra una vista lateral de cualquiera de las figuras anteriores.Figure 15 shows a side view of any of the previous figures.
La figura 16 muestra una sección E-F de la figura de la vista 14. Figure 16 shows a section E-F of the figure of view 14.
La figura 17 muestra el dispositivo de las figuras 12 a 15 con el acoplador de mascarilla conectado a un respirador y a una mascarilla situada sobre un paciente, observándose cómo la lámina cubre la cabeza del paciente, como los brazos operan por la parte inferior de la lámina introducidos en las dos bolsas tubulares, mientras una mano sujetando la mascarilla y otra el respirador. La cabeza del profesional médico se sitúa por encima de la lámina, separada de la cabeza de la paciente. Figure 17 shows the device of Figures 12 to 15 with the mask coupler connected to a respirator and to a mask placed on a patient, observing how the sheet covers the patient's head, as the arms operate by the lower part of the sheet introduced into the two tubular bags, while one hand holding the mask and the other the respirator. The head of the medical professional is positioned above the lamina, separated from the head of the patient.
REALIZACIÓN PREFERENTE DE LA INVENCIÓN PREFERRED EMBODIMENT OF THE INVENTION
A partir de las figuras anteriores y de la descripción de la invención realizada, a continuación, se incluyen varios ejemplos de realización de la invención, dispositivo de protección para disposición de un accesorio respiratorio sobre la vía aérea superior para proporcionar ventilación asistida y/o intubación con un video laringoscopio. Based on the previous figures and the description of the invention made below, several examples of embodiment of the invention are included, a protection device for disposing of a respiratory accessory over the upper airway to provide assisted ventilation and / or intubation. with a video laryngoscope.
Las figuras 1 a 5 muestran un dispositivo de protección preferido objeto de la invención que puede ser acoplado a un accesorio respiratorio, que preferiblemente será un acoplador para mascarilla o un video laringoscopio. El acoplador de mascarilla preferiblemente dispondrá medios para conectar al mismo una mascarilla y un respirador, que podrá ser bien de activación manual bien de activación automática. Figures 1 to 5 show a preferred protection device object of the invention that can be coupled to a respiratory accessory, which will preferably be a mask coupler or a video laryngoscope. The mask coupler will preferably have means for connecting a mask and respirator thereto, which may be either manually activated or automatically activated.
Se observa un dispositivo de protección para un accesorio respiratorio con una lámina 2 de un material plástico flexible y transparente, con una superficie superior y una superficie inferior con una primera abertura 3 y unos medios de retención herméticos 7 para el ajuste hermético del accesorio respiratorio a la lámina 2, de manera que el espacio sobre la superficie superior de la lámina se mantiene separado del espacio por debajo de la superficie inferior de la lámina y aislado de este, evitando que microrganismos pasen de un lado de la lámina al otro a través de los medios de retención herméticos 7. Dicha lámina 2 tiene preferiblemente una forma rectangular con sus esquinas redondeadas con unas dimensiones suficientes para cubrir la cabeza y el tórax del paciente sobre quien se va a disponer el accesorio respiratorio. La lámina 2 es preferiblemente de PVC con un espesor preferiblemente de 50 pm. A protection device for a respiratory accessory is observed with a sheet 2 of a flexible and transparent plastic material, with an upper surface and a lower surface with a first opening 3 and a hermetic retention means 7 for the hermetic adjustment of the respiratory accessory to sheet 2, so that the space on the upper surface of the sheet is kept separate and isolated from the space below the lower surface of the sheet, preventing microorganisms from passing from one side of the sheet to the other through the hermetic retention means 7. Said sheet 2 preferably has a rectangular shape with its rounded corners with sufficient dimensions to cover the head and thorax of the patient on whom the respiratory accessory is to be placed. Sheet 2 is preferably PVC with a thickness preferably 50 µm.
Los citados medios de retención herméticos 7 pueden comprender: un elemento de sujeción hermética 73 del accesorio respiratorio, acoplador de mascarilla o video laringoscopio, preferiblemente el mango de este, con medios para sujetar dicho accesorio y medios para unirse a la lámina, y/ o una placa soporte de refuerzo 71 con un orificio coincidente con el primer orificio de la lámina, preferiblemente adherida a la lámina, para dar rigidez a la lámina y facilitar la unión entre el accesorio respiratorio y la lámina, así como para separar la lámina del paciente durante la disposición del accesorio respiratorio para proporcionar ventilación asistida o proceder a la intrubación, y/ o un elemento complementario de hermeticidad 72, para reforzar la hermeticidad entre la superficie superior de la lámina 2 y/o la pieza de sujeción hermética 73 y/o el accesorio respiratorio, pudiendo ser, por ejemplo, una cubierta 72 o una cinta elástica. Said hermetic retention means 7 may comprise: a hermetic holding element 73 of the respiratory accessory, mask coupler or video laryngoscope, preferably its handle, with means to hold said accessory and means to join the sheet, and / or a reinforcing support plate 71 with a hole coinciding with the first hole of the sheet, preferably adhered to the sheet, to give rigidity to the sheet and facilitate the union between the respiratory accessory and the sheet, as well as to separate the sheet from the patient during disposition of the respiratory accessory to provide assisted ventilation or to proceed with intubation, and / or a complementary sealing element 72, to reinforce the sealing between the upper surface of the sheet 2 and / or the hermetic clamping piece 73 and / or the respiratory accessory, which may be, for example, a cover 72 or an elastic strap.
La figura 3 muestra cómo se acoplan los elementos anteriores entre sí, es decir, el elemento de sujeción hermética 73 unido a la superficie inferior de la placa soporte 71 y en la figura 4 el acoplamiento del elemento complementario de hermeticidad 72, en este caso una cubierta, por el lado superior de la placa soporte 71. En esta figura 4 no se ha incluido la lámina 2, dispuesta entre dicha cubierta 72 y la placa soporte 71 , estando está última unida a la superficie inferior de dicha lámina 2. Figure 3 shows how the previous elements are coupled to each other, that is, the hermetic fastening element 73 attached to the lower surface of the support plate 71 and in figure 4 the coupling of the complementary sealing element 72, in this case a cover, on the upper side of the support plate 71. In this figure 4 the sheet 2, arranged between said cover 72 and the support plate 71, is not included, being the latter attached to the lower surface of said sheet 2.
Los diferentes medios de retención 7, y en particular el elemento de sujeción hermética 73, estarán convenientemente particularizados, según el modelo de video laringoscopio y/o acoplador de mascarilla al que se destine el dispositivo 1 , para garantizar su sujeción y la hermeticidad o estanqueidad en la unión entre ambos, por lo que preferiblemente los medios de retención herméticos 7 comprenden un cuerpo tubular 73 cuyo interior es complementario al cuerpo accesorio respiratorio, acoplador o video laringoscopio y su exterior es complementario a la primera abertura 3. En la figura 3 se observa un elemento de sujeción hermética 73 que preferiblemente presenta una pieza de material plástico 73 con un cuerpo tubular, de sección aproximadamente cuadrada o rectangular, preferiblemente de un material tipo ABS o similar, unida a la parte inferior de la lámina 2, y en cuyo interior se introduce el acoplador de mascarilla o video laringoscopio, preferiblemente su mango. Los medios de unión del cuerpo tubular 73 a la lámina 2 o a la placa soporte de refuerzo 71 pueden ser de diferente naturaleza como, por ejemplo, orificios en las láminas 7, 71 complementarios a salientes en el elemento de sujeción 73. Por ejemplo, en la figura 3, se observan unos orificios 711 en la placa soporte 71 donde se introducen unos salientes 731 en el elemento anular y que se disponen en una aleta en el extremo superior de dicho elemento de sujeción hermética 73. Adicional y/o alternativamente, los medios de unión pueden ser a presión, mediante adhesivos y/o termo soldadura entre ambos componentes. Dicho elemento de sujeción 73 puede incorporar un gancho 732 para facilitar la sujeción y orientación del extremo proximal del tubo endotraqueal y su fácil introducción en la zona inferior de una bolsa 51 dispuesta en el lado superior de la lámina 2 (que se describirá posteriormente). The different retention means 7, and in particular the hermetic fastening element 73, will be conveniently customized, according to the video laryngoscope and / or mask coupler model to which the device 1 is intended, to guarantee its hold and the hermetic or watertightness. at the junction between the two, so preferably the hermetic retention means 7 comprise a tubular body 73 whose interior is complementary to the respiratory accessory body, coupler or video laryngoscope and its exterior is complementary to the first opening 3. Figure 3 shows observes a hermetic fastening element 73 that preferably has a piece of plastic material 73 with a tubular body, of approximately square or rectangular section, preferably made of an ABS or similar material, attached to the lower part of the sheet 2, and in which Inside, the mask or video laryngoscope coupler is inserted, preferably its handle. The means for joining the tubular body 73 to the sheet 2 or to the reinforcing support plate 71 may be of a different nature, such as, for example, holes in the sheets 7, 71 complementary to projections in the fastening element 73. For example, in Figure 3 shows holes 711 in the support plate 71 where projections 731 are inserted in the annular element and which are arranged in a fin at the upper end of said hermetic fastening element 73. Additionally and / or alternatively, the Joining means can be pressure, by means of adhesives and / or thermo-welding between both components. Said fastening element 73 may incorporate a hook 732 to facilitate the holding and orientation of the proximal end of the endotracheal tube and its easy insertion in the lower zone of a bag 51 arranged on the upper side of the sheet 2 (which will be described later).
Como se ha adelantado, los medios de retención 7 pueden comprender una placa soporte de refuerzo 71 (figuras 1 y 3 a 7), con una abertura 713 coincidente con la primera abertura 3 de la lámina 2. El objetivo de dicha placa soporte de refuerzo 71 es crear una campana sobre la cabeza del paciente 10 para evitar el contacto directo de la lámina 2 sobre el paciente durante la disposición del accesorio respiratorio, la realización de la ventilación mediante la mascarilla o la realización de la intubación y también proporcionar un espacio de trabajo para que el profesional médico, o intubador, pueda manipular la mascarilla y/o un respirador acoplado también al acoplador de mascarilla, o el video laringoscopio con comodidad. Como se ha mencionado, sobre dicha lámina se ajusta el elemento de sujeción hermética 73. Asimismo, la placa soporte puede presentar un entrante 712 (figuras 1 y 3 a 7) para, entre otras particularidades, facilitar la manipulación del tubo endotraqueal 413, o el respirador, desde el lado inferior de la lámina 2. As has been advanced, the retention means 7 may comprise a reinforcing support plate 71 (Figures 1 and 3 to 7), with an opening 713 coinciding with the first opening 3 of the sheet 2. The purpose of said reinforcing support plate 71 is to create a bell over the head of the patient 10 to avoid direct contact of the sheet 2 on the patient during the provision of the respiratory accessory, the performance of mask ventilation or intubation and also provide a workspace for the medical professional, or intubator, to manipulate the mask and / or a respirator also attached to the mask coupler, or the video laryngoscope in comfort. As mentioned, the hermetic fastening element 73 is fitted on said sheet. Likewise, the support plate can have a recess 712 (Figures 1 and 3 to 7) to, among other features, facilitate the handling of the endotracheal tube 413, or the respirator, from the underside of the sheet 2.
Dicha placa soporte 71 es preferiblemente de un material plástico transparente, como PVC con una mayor rigidez que el material de la lámina, y preferiblemente un espesor de preferiblemente 2 mm. Said support plate 71 is preferably made of a transparent plastic material, such as PVC with a greater rigidity than the sheet material, and preferably a thickness of preferably 2 mm.
En cualquiera de las dos alternativas anteriores, con o sin placa soporte 71 de refuerzo 71 , el elemento de sujeción hermético 73, podrá presentar diferentes construcciones, adaptadas tanto a la forma de la primera abertura 3 en la lámina 2 como a la forma del accesorio respiratorio que se introduce en el interior del elemento anular 73. En relación con los accesorios respiratorios, el elemento de sujeción 73 habitualmente se adaptará a la forma del video laringoscopio, mientras que, por el contrario, será el acoplador de mascarilla el que se adapte al elemento de sujeción 73. Esto será así porque preferiblemente un mismo dispositivo de protección 1 se empleará para realizar una intubación con un video laringoscopio que irá precedida de la utilización de una mascarilla con un acoplador para el suministro de oxígeno al paciente previamente a la intubación. Diferentes elementos de sujeción hermética 73 podrían ser: In either of the two previous alternatives, with or without reinforcing support plate 71, the hermetic fastening element 73 may have different constructions, adapted both to the shape of the first opening 3 in the sheet 2 and to the shape of the accessory. respirator that is inserted inside the annular element 73. In relation to the respiratory accessories, the fastening element 73 will usually adapt to the shape of the video laryngoscope, while, on the contrary, it will be the mask coupler that adapts to the clamping element 73. This will be the case because preferably the same protection device 1 will be used to perform an intubation with a video laryngoscope that will be preceded by the use of a mask with a coupler to supply oxygen to the patient prior to intubation . Different hermetic fasteners 73 could be:
El elemento de sujeción hermética del accesorio respiratorio puede tener diferentes construcciones y componentes, por ejemplo, entre otras construcciones posibles, puede comprender: una pieza tubular 73 de material plástico unida por su extremo superior a la superficie inferior de la lámina 2 o de la placa soporte 71 , coincidiendo el hueco del cuerpo tubular con el primer orificio 3 de la lámina 2. En el hueco del cuerpo tubular 73, cuya sección del hueco es preferiblemente complementario con la sección exterior del accesorio respiratorio, acoplador de mascarilla y/o mango o cuerpo del video laringoscopio, y en el que se introduce dicho accesorio respiratorio, pudiendo presentar una junta interioren el perímetro del hueco, para mejorar la hermeticidad con la unión del accesorio respiratorio, mientras que la sección exterior del cuerpo tubular 73 no presenta una limitación; y/ o una pieza tubular 73 de material plástico en la que se introduce el accesorio respiratorio, similar a la anterior, pero que para conseguir el cierre hermético entre ambos se dispone una cinta elástica que es comprimida mediante el accionamiento de una leva; y/ o una pieza tubular de material plástico y en la que se introduce el accesorio respiratorio, donde el cuerpo tubular presenta en su hueco interior un material tipo goma o neopreno, que determina un hueco interior en la pieza que no es complementario con el del accesorio respiratorio. Dicha pieza tubular puede abrirse, mediante por ejemplo una articulación, para la introducción del accesorio respiratorio en su interior y posteriormente cerrarse para que el material del hueco interior se adapte a la forma del cuerpo exterior del accesorio respiratorio. Los medios de cierre pueden ser de diferente tipo como por ejemplo una brida o similar. Esta pieza tubular se uniría posteriormente a la lámina o a la placa soporte mediante, por ejemplo, adhesivo o una cinta adhesiva que garantice la hermeticidad entre el extremo superior de la pieza tubular y la superficie inferior de la lámina o placa soporte; y/o una pieza con un cuerpo anular de material elástico, unido o acoplado al perímetro de la primera abertura de la lámina o de la abertura de la placa soporte, y en el que se introduce de manera ajustada el accesorio respiratorio; y/ o Una cinta adhesiva, adherida preferiblemente a la superficie inferior de la lámina o de la placa soporte, y que se pueda adherir también al accesorio respiratorio, de manera que una parte de la cinta está adherida a la lámina y otra parte de la cinta se adhiere al accesorio respiratorio tras su introducción en el primer orificio, cerrando el hueco que pueda existir entre la lámina y el accesorio respiratorio y por lo tanto consiguiendo un cierre hermético en la unión entre dicha primera abertura 3 y el accesorio respiratorio. The hermetic fastening element of the respiratory accessory can have different constructions and components, for example, among other possible constructions, it can comprise: a tubular piece 73 of plastic material joined at its upper end to the lower surface of the sheet 2 or of the plate support 71, the hollow of the tubular body coinciding with the first hole 3 of the sheet 2. In the hollow of the tubular body 73, whose section of the hollow is preferably complementary with the outer section of the respiratory accessory, mask coupler and / or handle or body of the video laryngoscope, and into which said accessory is inserted respiratory system, being able to present an internal gasket around the perimeter of the hole, to improve the hermeticity with the joint of the respiratory accessory, while the outer section of the tubular body 73 does not present a limitation; and / or a tubular piece 73 of plastic material in which the respiratory accessory is inserted, similar to the previous one, but that to achieve the hermetic closure between both an elastic tape is arranged that is compressed by actuating a cam; and / or a tubular piece of plastic material and into which the respiratory accessory is inserted, where the tubular body has a rubber or neoprene-type material in its interior hole, which determines an interior hole in the piece that is not complementary to that of the respiratory accessory. Said tubular piece can be opened, for example by means of a joint, for the introduction of the respiratory accessory into its interior and subsequently closed so that the material of the interior hole adapts to the shape of the outer body of the respiratory accessory. The closing means can be of a different type, such as a flange or the like. This tubular piece would subsequently be joined to the sheet or the support plate by means of, for example, adhesive or an adhesive tape that guarantees the airtightness between the upper end of the tubular piece and the lower surface of the support sheet or plate; and / or a piece with an annular body of elastic material, attached or coupled to the perimeter of the first opening of the sheet or of the opening of the support plate, and into which the respiratory accessory is inserted in a tight manner; and / or An adhesive tape, preferably adhered to the lower surface of the sheet or of the support plate, and that can also be adhered to the respiratory accessory, so that a part of the tape is adhered to the sheet and another part of the The tape adheres to the respiratory accessory after its introduction into the first hole, closing the gap that may exist between the sheet and the respiratory accessory and therefore achieving a hermetic seal at the junction between said first opening 3 and the respiratory accessory.
El tercer posible componente de los medios de retención herméticos 7 es el ya citado elemento complementario de hermeticidad 72 (ver figura 1 , 3 y 4) para reforzar la hermeticidad entre la pieza de sujeción hermética 73 y la lámina 2 o la placa soporte 71 , dependiendo de si el dispositivo de protección 1 comprende o no dicha placa soporte 71. Este elemento complementario de hermeticidad 72 se dispone en la superficie superior de la lámina 2 para reforzar, por el lado superior de dicha lámina 2, la hermeticidad entre la superficie superior y/o el elemento de sujeción hermética 73 y/o el accesorio respiratorio, ya sea el acoplador de mascarilla o el video laringoscopio, preferiblemente su mango. Este elemento complementario de hermeticidad, preferiblemente será una cubierta 72, aunque también puede ser una cinta adhesiva, dependiendo del tipo de accesorio respiratorio a utilizar con el dispositivo de protección 1. The third possible component of the hermetic retention means 7 is the aforementioned complementary sealing element 72 (see figures 1, 3 and 4) to reinforce the seal between the hermetic clamping piece 73 and the sheet 2 or the support plate 71, depending on whether or not the protection device 1 comprises said support plate 71. This complementary sealing element 72 is arranged on the upper surface of the sheet 2 to reinforce, on the upper side of said sheet 2, the seal between the upper surface and / or the hermetic fastening element 73 and / or the accessory. respirator, either the mask coupler or the video laryngoscope, preferably its handle. This complementary sealing element will preferably be a cover 72, although it can also be an adhesive tape, depending on the type of respiratory accessory to be used with the protection device 1.
Como se ha mencionado, en las figuras 1 y 4 se observa una cubierta 72 de dichos medios de retención 7 unida a dicha superficie superior de la lámina 2. Dicha cubierta 72 está especialmente diseñada para un video laringoscopio y presenta un cuerpo tubular con una abertura superior que permite, ver figura 6C, la conexión de una cámara 412 sobre el extremo proximal del mango 410 de este tipo de video laringoscopio 41. En las figuras 13, 14 y 15 se observa una cubierta 72 como la anterior que para su uso con un acoplador de mascarilla 9 presenta la abertura superior de la cubierta tapada, preferiblemente con una cinta adhesiva. Así se evita la salida de posibles microorganismos desde la parte inferior de la lámina 2 hasta la parte superior de la misma. Esta cubierta 72 preferiblemente es de un material plástico transparente, preferiblemente PVC con un espesor preferiblemente de 20 pm. As mentioned, figures 1 and 4 show a cover 72 of said retention means 7 attached to said upper surface of sheet 2. Said cover 72 is specially designed for a video laryngoscope and has a tubular body with an opening It allows, see Figure 6C, the connection of a camera 412 on the proximal end of the handle 410 of this type of video laryngoscope 41. In Figures 13, 14 and 15 a cover 72 like the previous one can be seen that for use with A mask coupler 9 has the upper opening of the cover covered, preferably with an adhesive tape. This prevents possible microorganisms from escaping from the bottom of the sheet 2 to the top of it. This cover 72 is preferably made of a transparent plastic material, preferably PVC with a thickness preferably of 20 µm.
A continuación, se describirá el dispositivo de protección 1 con un video laringoscopio 42, 42, 43, como accesorio respiratorio, en particular con referencia a las figuras 6A, 6B, 6C, 7 y 8. Next, the protection device 1 with a video laryngoscope 42, 42, 43 will be described as a respiratory accessory, in particular with reference to Figures 6A, 6B, 6C, 7 and 8.
En aquellos casos en los que el dispositivo de protección 1 esté destinado a ser utilizado con un video laringoscopio que incorpore un canal para facilitar la introducción de un tubo endotraqueal 413 (figuras 1 , 2, 5, 6C y 7), la lámina 2 comprende una segunda abertura 5 que es adyacente a la primera abertura 3 y presenta, unida a dicha segunda abertura 5, un contenedor o bolsa 51 (ver figura 2). La única embocadura 5 del contenedor o bolsa 51 queda unida al perímetro de la segunda abertura 5 preferiblemente por un adhesivo o por termo soldadura. Dicha bolsa o contenedor 51 se une a la superficie superior de la lámina 2 (ver figura 2) y su objetivo es recibir al menos el tubo endotraqueal 413 empleado para la intubación y que puede o no incorporar un elemento de guía en su interior. El tubo endotraqueal 413 se introduce en la bolsa 5, o contenedor, por la parte inferior de la lámina 2 y simultáneamente a la introducción del video laringoscopio en la primera abertura 3. Durante y después de la intubación el intubador podrá manipular el tubo 413 desde la parte inferior de la lámina 2 con una mano mientras sujeta con la contraria el video laringosocopio. Dicha bolsa o contenedor 51 es también preferiblemente de un material plástico transparente, preferiblemente PVC con un espesor preferiblemente de 50 pm. In those cases in which the protection device 1 is intended to be used with a video laryngoscope that incorporates a channel to facilitate the introduction of an endotracheal tube 413 (Figures 1, 2, 5, 6C and 7), sheet 2 comprises a second opening 5 which is adjacent to the first opening 3 and has, joined to said second opening 5, a container or bag 51 (see figure 2). The only mouth 5 of the container or bag 51 is joined to the perimeter of the second opening 5 preferably by an adhesive or by heat welding. Said bag or container 51 is attached to the upper surface of sheet 2 (see figure 2) and its objective is to receive at least the endotracheal tube 413 used for intubation and which may or may not incorporate a guide element inside it. The endotracheal tube 413 is inserted into the bag 5, or container, through the lower part of the sheet 2 and simultaneously with the introduction of the video laryngoscope in the first opening 3. During and after intubation the The intubator will be able to manipulate tube 413 from the underside of sheet 2 with one hand while holding the video laryngoscope with the other hand. Said bag or container 51 is also preferably made of a transparent plastic material, preferably PVC with a thickness preferably of 50 pm.
Asimismo, en aquellos dispositivos en los que la placa soporte presente un entrante 712 (figuras 1 y 3 a 7) para facilitar la manipulación del tubo endotraqueal 413 desde el lado inferior de la lámina 2, dicho entrante coincidirá con dicha segunda abertura 5 para poder acceder a la bolsa o contenedor 51 del tubo endotraqueal 413. Likewise, in those devices in which the support plate has a recess 712 (Figures 1 and 3 to 7) to facilitate the manipulation of the endotracheal tube 413 from the lower side of the sheet 2, said recess will coincide with said second opening 5 to be able to access bag or container 51 of endotracheal tube 413.
El dispositivo de protección 1 objeto de la invención podrá emplearse con diferentes tipos de videos laringoscopios, mediante ligeras adaptaciones del dispositivo 1 a las características y geometrías de los mangos de los diferentes video laringoscopios. The protection device 1 object of the invention may be used with different types of video laryngoscopes, by means of slight adaptations of the device 1 to the characteristics and geometries of the handles of the different video laryngoscopes.
La figura 6C muestra un dispositivo 1 objeto de la invención para su utilización con un video laringoscopio tipo Airtraq© o similar 41 , siendo estos del tipo que presentan un mango 410 en el extremo proximal del video laringoscopio 41 y sobre el que se acopla un visor o una cámara 412, pudiendo incluir además un canal lateral para facilitar la introducción y guiado del tubo endotraqueal 413 en el paciente. Para este tipo de video laringoscopios 41 en los que la cámara 412 se acopla y desacopla del cuerpo del video laringoscopio 41 , el mango 410 del video laringoscopio 41 se introduce en el elemento de sujeción hermética 73 por la parte inferior de la lámina 2, por lo que para asegurar la hermeticidad de la conexión entre el elemento de sujeción hermética 73 y la lámina 2, se dispone sobre la superficie superior de esta, y unida a la misma, la citada cubierta 72 (figuras 1 y 4) Figure 6C shows a device 1 object of the invention for use with a video laryngoscope type Airtraq © or similar 41, these being of the type that have a handle 410 at the proximal end of the video laryngoscope 41 and on which a viewer is attached. or a chamber 412, and may also include a lateral channel to facilitate the introduction and guidance of the endotracheal tube 413 in the patient. For this type of video laryngoscope 41 in which the camera 412 is coupled and uncoupled from the body of the video laryngoscope 41, the handle 410 of the video laryngoscope 41 is inserted into the hermetic holding element 73 through the lower part of the sheet 2, by which to ensure the tightness of the connection between the hermetic fastening element 73 and the sheet 2, the aforementioned cover 72 is arranged on the upper surface of the sheet, and attached thereto (Figures 1 and 4)
En el caso anterior, el dispositivo 1 presenta también una bolsa o contenedor 51 para albergar el tubo endotraqueal 413 durante el proceso de intubación. In the above case, the device 1 also has a bag or container 51 to house the endotracheal tube 413 during the intubation process.
El dispositivo 1 de la presente invención con un video laringoscopio 41 , tipo Airtraq© o similar, previamente a la conexión de la pantalla 412, se puede observar en las figuras 8 y 9. The device 1 of the present invention with a video laryngoscope 41, type Airtraq © or similar, prior to the connection of the screen 412, can be seen in Figures 8 and 9.
Una alternativa al dispositivo de protección 1 anterior, para su uso con un video laringoscopio tipo Glydescope© y que presenta un cuerpo único 430 con una conexión 431 por cable 432 en el extremo proximal del video laringoscopio 43, y sin un canal de introducción de un tubo endotraqueal se muestra en la figura 6A. En la misma, se observa como el dispositivo protector 1 , comprende una lámina 2, sin segunda abertura ni bolsa, aunque si presenta los medios de retención herméticos 7 que comprenden una placa soporte 71 y un elemento de sujeción hermética 73. Dicho elemento de sujeción hermética 73 estará adaptado interiormente a la forma exterior del extremo proximal del video laringoscopio y exteriormente a la forma de la abertura 3. En este caso, al disponer el video laringoscopio 43 de un cable 432 en su extremo proximal, la introducción en el primer orificio 3 del dispositivo de protección 1 se realiza por la superficie superior de la lámina 2 y posteriormente se procede a la introducción del video laringoscopio 43 en el paciente. Para ello, se sujeta el video laringoscopio 43 por el cuerpo 430 del mismo manteniendo las manos por debajo de la lámina 2 y la cabeza del intubador por encima de dicha lámina, de manera que el intubador no comparta espacio con el paciente, ya que dicho espacio queda dividido en dos por la lámina 2. El tubo endotraqueal se introduciría también por debajo de dicha lámina 2. An alternative to the protective device 1 above, for use with a Glydescope © type video laryngoscope and featuring a single body 430 with a 431 cable connection 432 at the proximal end of the video laryngoscope 43, and without an introduction channel for a Endotracheal tube is shown in Figure 6A. In it, it is observed how the protective device 1 comprises a sheet 2, without a second opening or bag, although it does present the hermetic retention means 7 that comprise a support plate 71 and a hermetic clamping element 73. Said hermetic clamping element 73 will be adapted internally to the outer shape of the proximal end of the video laryngoscope and externally to the shape of the opening 3. In this case, when arranging the video laryngoscope 43 of a cable 432 at its proximal end, the introduction into the first hole 3 of the protection device 1 is carried out through the upper surface of the sheet 2 and subsequently the video laryngoscope 43 is introduced into the patient. To do this, the video laryngoscope 43 is held by its body 430, keeping the hands below the sheet 2 and the head of the intubator above said sheet, so that the intubator does not share space with the patient, since said The space is divided in two by the lamina 2. The endotracheal tube would also be inserted under the lamina 2.
Alternativamente, si los medios de conexión 431 se pudieran separar del cuerpo del video laringoscopio 430, el acoplamiento del video laringoscopio con el dispositivo de protección 1 objeto de la invención se realizaría como en el caso anteriormente descrito. Alternatively, if the connection means 431 could be separated from the body of the video laryngoscope 430, the coupling of the video laryngoscope with the protection device 1 object of the invention would be carried out as in the case described above.
Otra alternativa es la utilización del dispositivo de protección 1 anterior, con un video laringoscopio tipo McGrath© 42 y que presenta un cuerpo único 420 con una pantalla 422 en el extremo proximal 421 del video laringoscopio 42, y sin un canal de introducción de un tubo endotraqueal, se muestra en la figura 6B. En la misma, se observa como el dispositivo protector 1, comprende una lámina 2 sin segunda abertura ni bolsa, aunque si presenta los medios de retención herméticos 7 que comprenden una placa soporte 71 y un elemento de sujeción hermética 73. Dicho elemento de sujeción hermética 73estará adaptado interiormente a la forma exterior del extremo proximal del video laringoscopio y exteriormente a la forma de la abertura 3. En este caso, al disponer el video laringoscopio 42 de una pantalla 422 en su extremo proximal 421 , la introducción en el primer orificio 3 del dispositivo de protección 1 se realiza por la superficie superior de la lámina 2 y posteriormente se procede a la introducción del video laringoscopio 43 en el paciente. Para ello, se sujeta el video laringoscopio 43 por el cuerpo 430 del mismo manteniendo las manos por debajo de la lámina 2 y la cabeza del intubador por encima de dicha lámina, de manera que el intubador no comparta espacio con el paciente, ya que dicho espacio queda dividido en dos por la lámina. El tubo endotraqueal se introduce también por debajo de dicha lámina 2. Another alternative is the use of the anterior protection device 1, with a McGrath © type video laryngoscope 42 and which presents a single body 420 with a screen 422 at the proximal end 421 of the video laryngoscope 42, and without a tube introduction channel. endotracheal, is shown in Figure 6B. In it, it is observed how the protective device 1 comprises a sheet 2 without a second opening or bag, although it does present the hermetic retention means 7 that comprise a support plate 71 and a hermetic clamping element 73. Said hermetic clamping element 73 will be adapted internally to the external shape of the proximal end of the video laryngoscope and externally to the shape of the opening 3. In this case, when the video laryngoscope 42 has a screen 422 at its proximal end 421, the introduction into the first hole 3 of the protection device 1 is made by the upper surface of the sheet 2 and then the video laryngoscope 43 is introduced into the patient. To do this, the video laryngoscope 43 is held by its body 430, keeping the hands below the sheet 2 and the head of the intubator above said sheet, so that the intubator does not share space with the patient, since said space is divided in two by the sheet. The endotracheal tube is also introduced below said sheet 2.
En la figura 7 se observa un ejemplo de un dispositivo de protección 1 conforme a la invención dispuesto sobre un paciente 8. En concreto, se observa el dispositivo de protección 1 con un video laringoscopio 41 acoplado como el de la figura 6C introducido en un paciente 8. El profesional o intubador cogerá con las manos 9 el laringoscopio por la parte inferior de la lámina 2, equivalente al lado sucio, manteniendo su cabeza por la parte superior de la misma, equivalente al lado limpio, de manera que ambas cabezas, la del intubador y la del paciente intubado 8, se encuentren separadas por la lámina 2, pero las manos 9 del intubador estén en el lado inferior sin interferencia de la lámina 2. Durante la intubación se introduce el tubo endotraqueal 413 en el paciente. En el caso concreto del video laringoscopio 41 mostrado y que integra un canal para guiar el tubo endotraqueal 413, estilo Airtraq© u otros, el extremo distal del tubo endotraqueal 413 se encuentra en el canal del video laringoscopio 41 y el extremo proximal está alojado en la bolsa o contenedor 51 del dispositivo 1 objeto de la invención, de manera que durante la intubación el intubador puede con una mano 9 deslizar el tubo endotraqueal 413 hacia el interior del paciente 9, en concreto hacia la traquea, mientras que con la otra mano 9 sujeta el video laringoscopio 41. El intubador puede observar todo el procedimiento de intubación a través de la pantalla 412. Se observa como la placa soporte 71 de los medios de retención herméticos 7 evita el contacto de la lámina 2 con el paciente 8. Figure 7 shows an example of a protection device 1 according to the invention arranged on a patient 8. Specifically, the device for protection 1 with a video laryngoscope 41 attached like the one in figure 6C inserted into a patient 8. The professional or intubator will hold the laryngoscope with his hands 9 by the lower part of the sheet 2, equivalent to the dirty side, keeping his head by the upper part of it, equivalent to the clean side, so that both heads, that of the intubator and that of the intubated patient 8, are separated by plate 2, but the hands 9 of the intubator are on the lower side without interference from the Plate 2. During intubation, endotracheal tube 413 is introduced into the patient. In the specific case of the video laryngoscope 41 shown and which integrates a channel to guide the endotracheal tube 413, Airtraq © style or others, the distal end of the endotracheal tube 413 is located in the channel of the video laryngoscope 41 and the proximal end is housed in the bag or container 51 of the device 1 object of the invention, so that during intubation the intubator can with one hand 9 slide the endotracheal tube 413 into the patient 9, specifically towards the trachea, while with the other hand 9 holds the video laryngoscope 41. The intubator can observe the entire intubation procedure through the screen 412. It is observed how the support plate 71 of the hermetic retention means 7 prevents contact of the blade 2 with the patient 8.
Una vez finalizada la intubación, se retira el video laringoscopio 41 de la boca del paciente 8 junto a la lámina 2, manteniendo el tubo endotraqueal 413 en el paciente 8. Un ayudante del intubador, que no haya estado en contacto con el lado sucio situado por debajo del dispositivo protector 1 , podrá retirar la cámara 412 del video laringoscopio 41 o desconectar los cables del video laringoscopio 431 , en el caso que se pueda, que siempre han permanecido aislados del paciente, y por la tanto no han sido contaminados, para su posterior reutilización. Once the intubation is complete, the video laryngoscope 41 is removed from the mouth of patient 8 next to plate 2, keeping the endotracheal tube 413 in patient 8. An intubator assistant, who has not been in contact with the dirty side located below the protective device 1, you can remove the camera 412 from the video laryngoscope 41 or disconnect the cables from the video laryngoscope 431, if possible, which have always remained isolated from the patient, and therefore have not been contaminated, to its subsequent reuse.
La figura 10 muestra otro ejemplo de dispositivo de protección 1 conforme a la presente invención. El mismo puede comprender los mismos elementos que los anteriores, principalmente una lámina 2, con una primera abertura 3 y unos medios de retención herméticos 7. En la figura se observa la lámina 2, la bolsa o contenedor 51 y la cubierta 72, elementos ya mostrados y descritos anteriormente. Asimismo, el dispositivo de protección 1 de este ejemplo, presenta dos aberturas 8, aproximadamente circulares, en la lámina 2, que presentan unidas por la superficie inferior de esta lámina 2 un manguito tubular 81 , que también es preferiblemente de plástico. Dichos manguitos 81 están unidos por uno de sus extremos al perímetro de los orificios 8 de la lámina 2 mediante adhesivo o por termo soldadura. Por el extremo contrario 82 los manguitos 81 presentan una disminución de su diámetro, provocada, preferiblemente, por un elemento elástico, de manera que, al introducir las manos del profesional, cada bolsa tubular queda perfectamente cerrada sobre la mano, asegurando así la hermeticidad o estanqueidad. El material plástico de estos manguitos es preferiblemente PVC o un plástico de grado médico, que es transparente, y con un espesor preferiblemente de entre 30 pm y 100 pm, más preferiblemente 50 pm. Figure 10 shows another example of protection device 1 according to the present invention. It can comprise the same elements as the previous ones, mainly a sheet 2, with a first opening 3 and a hermetic retention means 7. The figure shows sheet 2, the bag or container 51 and the cover 72, elements already shown and described above. Likewise, the protection device 1 of this example has two openings 8, approximately circular, in the sheet 2, which have, joined by the lower surface of this sheet 2, a tubular sleeve 81, which is also preferably made of plastic. Said sleeves 81 are attached at one of their ends to the perimeter of the holes 8 of the sheet 2 by means of adhesive or by heat welding. On the other hand, 82 the sleeves 81 show a decrease in diameter, preferably caused by a elastic element, so that, when introducing the professional's hands, each tubular bag is perfectly closed on the hand, thus ensuring the hermeticity or watertightness. The plastic material of these sleeves is preferably PVC or a medical grade plastic, which is transparent, and with a thickness preferably between 30 pm and 100 pm, more preferably 50 pm.
El dispositivo 1 de protección, además puede incorporar en la superficie superior de la lámina 2, unas cintas adhesivas 21 que sirven para poder sujetar la lámina 2 a elementos de sujeción ajenos al dispositivo de protección 1, por ejemplo, un arco dispuesto sobre el paciente que se puede acoplar a las camas donde se realizan las intervenciones quirúrgicas. The protection device 1 can also incorporate on the upper surface of the sheet 2, adhesive tapes 21 that serve to hold the sheet 2 to fastening elements other than the protection device 1, for example, a bow arranged on the patient. that can be attached to the beds where surgical interventions are performed.
El dispositivo de protección 1 anteriormente descrito, en cualquiera de sus realizaciones, puede emplearse con diferentes accesorios respiratorios, bien con video laringoscopios, como se ha descrito con referencia a las figuras 6A a 9, bien con acopladores para mascarilla 9 como se muestra en las figuras 9 a 16. The protection device 1 described above, in any of its embodiments, can be used with different respiratory accessories, either with video laryngoscopes, as described with reference to Figures 6A to 9, or with mask couplers 9 as shown in the Figures 9 to 16.
Las figuras 10A a 12 muestras un ejemplo de un acoplador para mascarillas 9. Este acoplador de mascarilla 9 comprenderá un cuerpo hueco y al menos: Figures 10A to 12 show an example of a mask coupler 9. This mask coupler 9 will comprise a hollow body and at least:
Un primer orificio 91 para la salida de aire dispuesto en su extremo inferior o extremo distal para ser acoplado a la mascarilla facial 10 o casco que se dispondrá sobre la cara del paciente 8, A first hole 91 for the outlet of air arranged at its lower end or distal end to be coupled to the face mask 10 or helmet that will be arranged on the face of the patient 8,
Un saliente de acoplamiento 95 en su extremo superior o extremo proximal para ser acoplado al dispositivo de protección 1 , a través de los medios de retención herméticos 7 a la primera abertura 3 de la lámina 2, y en concreto a través del elemento de sujeción hermética 73 unido a la placa 71 , a su vez unida a la lámina 2, y A coupling projection 95 at its upper end or proximal end to be coupled to the protection device 1, through the hermetic retention means 7 to the first opening 3 of the sheet 2, and specifically through the hermetic fastening element 73 attached to plate 71, in turn attached to plate 2, and
Un segundo orificio 92 para la entrada de aire, desde un respirador 20, que está dispuesto entre el primer orificio 91 y el saliente de acoplamiento 95. A second port 92 for the inlet of air, from a respirator 20, which is disposed between the first port 91 and the coupling projection 95.
Las figuras 13 a 17 muestran un acoplador de mascarilla 9 conectado a un elemento de sujeción hermético 73 de un dispositivo de protección 1 conforme a la invención. Dicho elemento de protección 1 comprende una lámina 2, una placa 71 y una cubierta 72 con su orificio tapado, preferiblemente por una cinta adhesiva retirable. En este caso particular, se observa como el acoplador de mascarilla 9 presenta en dos de sus paredes laterales dos hendiduras 93 destinadas a recibir dos salientes complementarios dispuestos en el elemento de sujeción 73 en el que se introduce el acoplador de mascarilla 9. En la figura 17 se observa un dispositivo de protección 1 como el mostrado en la figura 10, con un acoplador de mascarilla 9 y sus accesorios. Dicho dispositivo 1 está dispuesto sobre un paciente 8 y el acoplador de mascarilla 9 por lo tanto se conecta con la mascarilla 10, o casco, a través del primer orificio 91 para, posteriormente, conectarse con la primera abertura 3 del dispositivo desde la superficie inferior de la lámina 2, empleando el elemento de sujeción hermética 73 de los medios de retención 7. El acoplador 9 se conecta también con un respirador 20, de accionamiento manual y/o automático, y accionado por el profesional desde el lado sucio, es decir, por debajo de la lámina 2. El profesional, por lo tanto, puede mantener una mano sobre la mascarilla 10 o casco sobre el paciente 8 y con la otra puede accionar o manipular el respirador 20. Figures 13 to 17 show a mask coupler 9 connected to a hermetic fastening element 73 of a protection device 1 according to the invention. Said protection element 1 comprises a sheet 2, a plate 71 and a cover 72 with its hole covered, preferably by a removable adhesive tape. In this particular case, it can be seen how the mask coupler 9 has on two of its side walls two slits 93 intended to receive two complementary projections arranged on the holding element 73 into which the mask coupler 9 is inserted. Figure 17 shows a protection device 1 as shown in figure 10, with a mask coupler 9 and its accessories. Said device 1 is arranged on a patient 8 and the mask coupler 9 therefore connects with the mask 10, or helmet, through the first hole 91 to subsequently connect with the first opening 3 of the device from the lower surface of the sheet 2, using the hermetic fastening element 73 of the retention means 7. The coupler 9 is also connected to a respirator 20, manually and / or automatically operated, and operated by the professional from the dirty side, that is to say , below sheet 2. The professional, therefore, can keep one hand on the mask 10 or helmet on the patient 8 and with the other can operate or manipulate the respirator 20.
Respecto a la lámina 2 y sus componentes, así como al accesorio de respiración acoplado a la misma, pueden ser reutilizados tras su desinfección y esterilización por cualquiera de los medios conocidos si los materiales de los distintos componentes lo permiten, o por el contrario, pueden ser directamente desechados junto al dispositivo de protección 1. Regarding the sheet 2 and its components, as well as the breathing accessory attached to it, they can be reused after disinfection and sterilization by any of the known means if the materials of the different components allow it, or on the contrary, they can be directly disposed of together with protection device 1.
Las figuras también muestran un sistema de protección para la disposición de un accesorio respiratorio sobre la vía aérea superior de una persona, bien para proporcionar ventilación asistida con una mascarilla bien para realizar una intubación con un video laringoscopio. El sistema por lo tanto comprende un accesorio respiratorio y un dispositivo de protección conforme a lo descrito anteriormente. The figures also show a protection system for the provision of a respiratory accessory over the upper airway of a person, either to provide assisted ventilation with a mask or to perform intubation with a video laryngoscope. The system therefore comprises a respiratory accessory and a protection device as described above.
Por ejemplo, conforme a lo anterior, las figuras 6A, 6B y 6C muestran, además de un dispositivo de protección 1 , un sistema de para intubaciones, que está conformado por un video laringoscopio 41 , 42, 43 y un dispositivo de protección 1 que esencialmente comprenderá una lámina 2 con una superficie superior y una superficie inferior, una primera abertura 3 para la introducción de un extremo de un video laringoscopio 4 y unos medios de retención herméticos 7 para el ajuste hermético de dicho video laringoscopio 4 a dicha primera abertura 3 de la lámina 2. For example, according to the above, Figures 6A, 6B and 6C show, in addition to a protection device 1, a system for intubations, which is made up of a video laryngoscope 41, 42, 43 and a protection device 1 that it will essentially comprise a sheet 2 with an upper surface and a lower surface, a first opening 3 for the introduction of one end of a video laryngoscope 4 and a hermetic retention means 7 for the hermetic adjustment of said video laryngoscope 4 to said first opening 3 of plate 2.
Asimismo, las figuras 13 a 17, muestran también, además de un dispositivo de protección 1 , un sistema para proporcionar ventilación asistida con una mascarilla o similar, que está conformado por un acoplador de mascarilla 9 y un dispositivo de protección 1 que esencialmente comprenderá una lámina 2 con una superficie superior y una superficie inferior, una primera abertura 3 para la introducción de un extremo del acoplador de mascarilla 9 y unos medios de retención herméticos 7 para el ajuste hermético de dicho acoplador de mascarilla 9 a dicha primera abertura 3 de la lámina 2. Likewise, Figures 13 to 17 also show, in addition to a protection device 1, a system for providing assisted ventilation with a mask or the like, which is made up of a mask coupler 9 and a protection device 1 that will essentially comprise a sheet 2 with an upper surface and a lower surface, a first opening 3 for the introduction of one end of the mask coupler 9 and a hermetic retention means 7 for the fit hermetic of said mask coupler 9 to said first opening 3 of the sheet 2.
Como se puede observar en las figuras 9, 15 y 16, la superficie de la placa soporte 71 y el eje vertical del elemento de sujeción hermética 73 pueden presentar un ángulo entre ambos que es menor de 90° y mayor de 70°. El motivo de esa inclinación del elemento de sujeción 73 respecto a la placa soporte 71 , o viceversa, y la lámina 2, es facilitar la introducción del accesorio respiratorio en la boca del paciente. Esta inclinación es especialmente útil cuando el accesorio respiratorio es un video laringoscopio, puesto que debido a su longitud y a la curva que es necesario hacer para su introducción en la boca, podría golpear o verse dificultada la introducción en la boca por el tórax del paciente 8. As can be seen in Figures 9, 15 and 16, the surface of the support plate 71 and the vertical axis of the sealing element 73 can have an angle between them that is less than 90 ° and greater than 70 °. The reason for this inclination of the clamping element 73 with respect to the support plate 71, or vice versa, and the sheet 2, is to facilitate the introduction of the respiratory accessory into the patient's mouth. This inclination is especially useful when the respiratory accessory is a video laryngoscope, since due to its length and the curve that must be made to insert it into the mouth, it could hit or be difficult to insert into the mouth through the patient's chest 8 .
Conforme a lo anteriormente descrito, el método de manipulación del dispositivo de protección para la disposición de un accesorio respiratorio sobre la vía aérea superior de una persona, bien para proporcionar ventilación asistida con una mascarilla bien para realizar una intubación con un video laringoscopio comprenderá al menos las siguientes etapas: a) Introducción por parte de un profesional médico del accesorio respiratorio en el primer oficio de la lámina por la parte inferior o por la parte superior de la misma y asegurar su hermeticidad. En el caso del acoplador de mascarilla se introducirá por la parte inferior, mientras que en el caso de un video laringoscopio, se introducirá el mango, o extremo proximal, del mismo en la primera abertura, por la parte inferior de la lámina o por la parte superior de la misma, dependiendo del tipo de video laringoscopio. Los medios de retención herméticos del dispositivo se emplearán para asegurar el acoplamiento hermético entre la lámina y el accesorio respiratorio. b) Sujeción con las manos del profesional médico del accesorio respiratorio por la parte inferior de la lámina a la vez que se mantiene la cabeza del profesional por la parte superior de la misma. As described above, the method of manipulating the protection device for the provision of a respiratory accessory on the upper airway of a person, either to provide assisted ventilation with a mask or to perform intubation with a video laryngoscope will comprise at least the following stages: a) Introduction by a medical professional of the respiratory accessory in the first job of the sheet from the bottom or top of it and ensure its tightness. In the case of the mask coupler, it will be inserted through the lower part, while in the case of a video laryngoscope, the handle, or proximal end, of the same will be inserted in the first opening, through the lower part of the sheet or through the top of it, depending on the type of video laryngoscope. The hermetic retention means of the device will be used to ensure the hermetic coupling between the foil and the breathing accessory. b) Holding the respiratory accessory with the hands of the medical professional by the lower part of the sheet while keeping the professional's head on the upper part of it.
En el caso de que el accesorio respiratorio sea un video laringoscopio, el profesional lo sujetará con sus manos por el extremo distal del mango o video laringoscopio, por debajo de la lámina, y posteriormente procederá a la introducción del extremo distal del laringoscopio o video laringoscopio, por la boca del paciente, y posterior manipulación del tubo endotraqueal para su introducción a través de las cuerdas vocales del paciente, manteniendo las manos del profesional médico, o intubador, por la parte inferior de la lámina y su cabeza separada por la parte superior de la lámina del dispositivo. In the event that the respiratory accessory is a video laryngoscope, the professional will hold it with his hands by the distal end of the handle or video laryngoscope, below the blade, and then proceed to the introduction of the distal end of the laryngoscope or video laryngoscope , through the patient's mouth, and subsequent manipulation of the endotracheal tube for its introduction through the patient's vocal cords, keeping the hands of the medical professional, or intubator, by the lower part of the blade and its head separated by the upper part of the device blade.
En el caso de que el accesorio respiratorio sea un acoplador de mascarilla, el profesional médico, además de conectar el acoplador al dispositivo, deberá conectar, o haber conectado previamente la mascarilla y el respirador a dicho acoplador. De esta manera, y siempre operando por la parte inferior de la lámina, o lado sucio, el profesional podrá sujetar con una mano la mascarilla sobre el paciente y con la otra mano accionar el respirado cuando este sea manual. In the event that the respiratory accessory is a mask coupler, the medical professional, in addition to connecting the coupler to the device, must connect, or have previously connected the mask and respirator to said coupler. In this way, and always operating from the lower part of the sheet, or dirty side, the professional will be able to hold the mask on the patient with one hand and with the other hand to activate the breathing when it is manual.

Claims

REIVINDICACIONES
1. Dispositivo de protección (1) para disposición de un accesorio respiratorio sobre la vía aérea superior para proporcionar ventilación asistida y/o intubación con un video laringoscopio, caracterizado porque comprende una lámina (2) con unas dimensiones suficientes para cubrir, al menos, la cabeza y la parte superior del tórax de un paciente, presentando dicha lámina (2): una superficie superior y una superficie inferior, una primera abertura (3) para la introducción de un extremo de un accesorio respiratorio, y unos medios de retención herméticos (7) para el ajuste hermético de dicho accesorio respiratorio a dicha primera abertura (3) de la lámina (2). 1. Protection device (1) for placing a respiratory accessory on the upper airway to provide assisted ventilation and / or intubation with a video laryngoscope, characterized in that it comprises a sheet (2) with sufficient dimensions to cover, at least, the head and the upper part of the thorax of a patient, said sheet (2) having: an upper surface and a lower surface, a first opening (3) for the introduction of one end of a respiratory accessory, and a hermetic retention means (7) for the hermetic fit of said respiratory accessory to said first opening (3) of the sheet (2).
2. Dispositivo, según reivindicación 1 , caracterizado porque dicha lámina (2) comprende una segunda abertura (5), adyacente a dicha primera abertura (3), con un contenedor o bolsa (51) cuya base inferior, coincidente con la única embocadura del contenedor (52), está unida de manera estanca con dicha segunda abertura (5) por la superficie superior de la lámina, para recibir al menos un tubo endotraqueal empleado para la intubación. Device, according to claim 1, characterized in that said sheet (2) comprises a second opening (5), adjacent to said first opening (3), with a container or bag (51) whose lower base, coinciding with the only mouth of the container (52), is tightly connected with said second opening (5) by the upper surface of the sheet, to receive at least one endotracheal tube used for intubation.
3. Dispositivo, según cualquiera de las reivindicaciones anteriores, caracterizado porque los medios de retención herméticos comprenden una placa soporte de refuerzo (71) unida a la lámina (2) presentando una abertura coincidente con la primera abertura (3) de la lámina (2). Device according to any of the preceding claims, characterized in that the hermetic retention means comprise a reinforcing support plate (71) joined to the sheet (2) presenting an opening coincident with the first opening (3) of the sheet (2). ).
4. Dispositivo, según cualquiera de las reivindicaciones anteriores, caracterizado porque los medios de retención herméticos (7) comprenden un elemento de sujeción hermética (73) entre el accesorio respiratorio y la lámina (2) o la placa soporte (71). Device according to any of the preceding claims, characterized in that the hermetic retention means (7) comprise a hermetic fastening element (73) between the respiratory accessory and the sheet (2) or the support plate (71).
5. Dispositivo, según reivindicación 4, caracterizado porque el elemento de sujeción hermética (73) comprende un cuerpo tubular cuyo interior es complementario al accesorio respiratorio. Device according to claim 4, characterized in that the hermetic fastening element (73) comprises a tubular body whose interior is complementary to the respiratory accessory.
6. Dispositivo, según cualquiera de las reivindicaciones anteriores, caracterizado porque los medios de retención (7) comprenden un elemento complementario de hermeticidad (72) dispuesto sobre la superficie superior de la lámina (2). Device according to any of the preceding claims, characterized in that the retention means (7) comprise a complementary sealing element (72) arranged on the upper surface of the sheet (2).
7. Dispositivo, según reivindicación 3, caracterizado porque la placa soporte (71) presenta un entrante (712). Device according to claim 3, characterized in that the support plate (71) has a recess (712).
8. Sistema para intubaciones, caracterizado porque comprende: Un dispositivo según la reivindicación 1 , y Un accesorio respiratorio. 8. Intubation system, characterized in that it comprises: A device according to claim 1, and A respiratory accessory.
9. Sistema, según reivindicación 8, caracterizado porque comprende un dispositivo según cualquiera de las reivindicaciones 2 a 7. 9. System according to claim 8, characterized in that it comprises a device according to any of claims 2 to 7.
10. Sistema, según reivindicación 8 o 9, caracterizado porque el accesorio respiratorio es un video laringoscopio (41 , 42, 43). 10. System, according to claim 8 or 9, characterized in that the respiratory accessory is a video laryngoscope (41, 42, 43).
11. Sistema, según reivindicación 8 o 9, caracterizado porque el accesorio respiratorio es un acoplador de mascarilla (9). System, according to claim 8 or 9, characterized in that the respiratory accessory is a mask coupler (9).
12. Sistema, según reivindicación 11 , caracterizado porque el acoplador de mascarilla comprende un cuerpo hueco: 12. System, according to claim 11, characterized in that the mask coupler comprises a hollow body:
Un primer orificio 91 para la salida de aire dispuesto en su extremo inferior o extremo distal para ser acoplado a la mascarilla facial 10 o casco que se dispondrá sobre la cara del paciente 8, A first hole 91 for the outlet of air arranged at its lower end or distal end to be coupled to the face mask 10 or helmet that will be arranged on the face of the patient 8,
Un saliente de acoplamiento 95 en su extremo superior o extremo proximal para ser acoplado al dispositivo de protección 1, a través de la primera abertura 3 de la lámina 2 mediante unos medios de retención herméticos 7, y Un segundo orificio 92 para la entrada de aire para el acoplamiento de un respirador 20, que está dispuesto entre el primer orificio 91 y el saliente de acoplamiento 95. A coupling projection 95 at its upper end or proximal end to be coupled to the protection device 1, through the first opening 3 of the sheet 2 by means of a hermetic retention means 7, and a second hole 92 for the air inlet for coupling a respirator 20, which is arranged between the first hole 91 and the coupling boss 95.
13. Método de manipulación del dispositivo de protección para la disposición de un accesorio respiratorio sobre la vía aérea superior de una persona, bien para proporcionar ventilación asistida con una mascarilla bien para realizar una intubación con un video laringoscopio comprenderá al menos las siguientes etapas: a) Introducción de un accesorio respiratorio en el primer oficio de la lámina por la parte inferior o por la parte superior de la misma y asegurar su hermeticidad, y b) Sujeción con las manos del profesional médico del accesorio respiratorio por la parte inferior de la lámina a la vez que se mantiene la cabeza del profesional por la parte superior de la misma. 13. Method of manipulation of the protection device for the provision of a respiratory accessory on the upper airway of a person, either to provide assisted ventilation with a mask or to perform intubation with a video laryngoscope, it will comprise at least the following steps: a ) Introduction of a respiratory accessory in the first office of the sheet from the lower part or the upper part of it and ensure its tightness, and b) Holding the respiratory accessory with the hands of the medical professional of the respiratory accessory by the lower part of the sheet a while keeping the professional's head on top of it.
PCT/ES2020/070249 2020-04-20 2020-04-20 Protective device for arranging a respiratory accessory over the upper airway to provide assisted ventilation and/or intubation with a video laryngoscope WO2021214349A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5140997A (en) * 1989-10-04 1992-08-25 Glassman Jacob A Ophthalmologic surgical drape with breathing means
US5488944A (en) * 1994-08-05 1996-02-06 Kennedy; Thomas M. Surgical drape support
US20030047189A1 (en) * 2001-09-05 2003-03-13 Kumar Matthew M. Intubating ventilatory face mask
US20160166322A1 (en) * 2014-12-10 2016-06-16 Matthew D. Lowrance Incise drape for surgical applications and method of positioning the drape over a patient
CN110772350A (en) * 2019-11-29 2020-02-11 遵义医科大学附属口腔医院 Oral cavity hole piece of cloth

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5140997A (en) * 1989-10-04 1992-08-25 Glassman Jacob A Ophthalmologic surgical drape with breathing means
US5488944A (en) * 1994-08-05 1996-02-06 Kennedy; Thomas M. Surgical drape support
US20030047189A1 (en) * 2001-09-05 2003-03-13 Kumar Matthew M. Intubating ventilatory face mask
US20160166322A1 (en) * 2014-12-10 2016-06-16 Matthew D. Lowrance Incise drape for surgical applications and method of positioning the drape over a patient
CN110772350A (en) * 2019-11-29 2020-02-11 遵义医科大学附属口腔医院 Oral cavity hole piece of cloth

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