WO2017107991A1 - 用于呼吸面罩的衬垫和呼吸面罩 - Google Patents

用于呼吸面罩的衬垫和呼吸面罩 Download PDF

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Publication number
WO2017107991A1
WO2017107991A1 PCT/CN2016/111814 CN2016111814W WO2017107991A1 WO 2017107991 A1 WO2017107991 A1 WO 2017107991A1 CN 2016111814 W CN2016111814 W CN 2016111814W WO 2017107991 A1 WO2017107991 A1 WO 2017107991A1
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WO
WIPO (PCT)
Prior art keywords
contact
support portion
face
pad
patient
Prior art date
Application number
PCT/CN2016/111814
Other languages
English (en)
French (fr)
Inventor
周明钊
王亚杰
庄志
Original Assignee
北京怡和嘉业医疗科技股份有限公司
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.)
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Application filed by 北京怡和嘉业医疗科技股份有限公司 filed Critical 北京怡和嘉业医疗科技股份有限公司
Priority to US15/744,803 priority Critical patent/US11160943B2/en
Priority to EP16877801.7A priority patent/EP3395389B1/en
Publication of WO2017107991A1 publication Critical patent/WO2017107991A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
    • A61M16/0622—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure having an underlying cushion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0611—Means for improving the adaptation of the mask to the patient with a gusset portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0606—Face
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose

Definitions

  • the present application relates to the field of breathing mask technology, and in particular to a cushion and a respiratory mask for a respiratory mask.
  • a respiratory mask as a non-invasive ventilation therapy has been widely used to treat Obstructive Sleep Apnea (OSA), Chronic Obstructive Pulmonary Disease (COPD), and the like.
  • the breathing mask is connected to the ventilator through a tube, a continuous positive airway pressure (CPAP) or a variable pressure ventilation to the patient's airway, such as bi-level pressure ventilation as the patient's respiratory cycle changes or with the patient Automatic pressure regulation ventilation that monitors changes in conditions.
  • CPAP continuous positive airway pressure
  • This stress-supported therapy is also commonly used in diseases such as obstructive sleep hypopnea, upper airway resistance Syndrome (UARS) or congestive heart failure.
  • UARS upper airway resistance Syndrome
  • Current breathing masks typically include a frame and a cushion.
  • a fixation device such as a headgear
  • the cushion contacts the patient's face to form a sealed cavity with the patient's face.
  • Existing ventilation treatments are usually long-term, and patients often wear respiratory masks overnight. Based on this, the breathing mask should be as comfortable as possible and the seal should be as stable as possible, both of which are related to the liner. If the patient feels that the wearing comfort is not enough, the treatment may be refused. If the sealing degree is not enough, it may cause gas leakage. On the one hand, the pressure is lower than the treatment value, and the treatment is invalid. On the other hand, the leaked airflow may impact the patient's face, especially in the sensitive bridge of the nose or the eye. Can cause discomfort, causing the patient to refuse treatment.
  • the existing gaskets are mainly classified into two types of double-layer film liners and single-layer film liners according to their structures.
  • the above double-layer film liner generally comprises a sealing unit and a supporting unit which are layered up and down.
  • the disadvantage of the two-layer film liner technology is that it is complicated to manufacture, expensive, and inconvenient to clean, which are advantages of the single-layer film liner.
  • the problem with the existing single-layer film liner technology is that on the one hand, the comfort is limited, and on the other hand, leakage is liable to occur.
  • the single-layer film liner that is, the support unit and the sealing unit are integrated.
  • the problem of sealing mainly depends on the force of the contact portion of the pad with the face.
  • the present application provides a gasket for a respiratory mask and a respiratory mask having the same.
  • a pad for a respiratory mask comprising: a connecting portion for connecting to a frame or an elbow assembly of the respiratory mask; a face contact portion for contacting the patient a face portion, the face contact portion being formed of a thin film; and a support portion connected between the connection portion and the face contact portion, wherein at least a portion of the face contact portion has a direction from the support portion An outer extension portion of the spacer and an inner extension portion extending from an outer peripheral side of the extension portion toward the inside of the spacer.
  • the inner extension has a high point
  • the inner extension portion is defined by the high point as a first inner extension portion connected to the extension portion and a first connection portion connected to the first inner extension portion a second internal portion; the high point of the inner extension portion abuts against the support portion under the action of the face of the patient.
  • the first inner extension forms a closed airbag with the extension, and the first inner extension is in contact with the face of the patient to form a second sealing area.
  • the second inward portion is tilted toward the face of the patient and sealed in contact with the face of the patient to form a first sealing region under the action of the face of the patient.
  • the maximum thickness of the face contact portion is smaller than the minimum thickness of the support portion.
  • the support portion includes a pressure support portion and a contact support portion connected to each other, wherein the pressure support portion is connected to the connection portion, and the pressure support portion is used to form a patient cavity of the pad; And wherein the contact support portion is connected to the face contact portion, the contact support portion is a transition portion between the pressure support portion and the face contact portion, under the action of the face of the patient, The face contact portion abuts against the contact support portion.
  • the pressure support portion and/or the contact support portion are inclined toward the outside of the pad in a direction from the connecting portion to the face contact portion.
  • the angle of inclination of the pressure support portion with respect to the longitudinal direction of the pad is 3-15 degrees.
  • the inner peripheral surface of the contact support portion is a circular arc that protrudes toward the inside of the gasket.
  • the contact support portion includes a first contact support portion and a second contact support portion, the first contact support portion extending from the pressure support portion toward an inner portion of the pad, the second portion A contact support portion extends from the first contact support portion toward the outside of the pad to the face contact portion to form a groove between the first contact support portion and the second contact support portion.
  • the second contact support is laminated on the first contact support under the action of the patient's face.
  • the second contact support portion is formed of a thin film, or/and the thickness of the first contact support portion is gradually thinned from a direction in which the pressure support portion extends to the second contact support portion.
  • the groove is flared towards the outside of the pad.
  • the second contact support is smoothly curved from the first contact support such that the bottom of the groove is rounded.
  • the connecting portion includes: a connecting portion for connecting to the breathing mask, the connecting portion has a lateral dimension smaller than a lateral dimension of the supporting portion; and a bending portion connected to the connecting portion Between the segment and the support portion.
  • the pad includes an upper region, a lower region, and a central region connected between the upper region and the lower region, from the upper region and the From the lower region to the intermediate region, the lateral width of the bent segment gradually decreases.
  • a respiratory mask comprising: a frame having a gas outlet for connecting to a bend; and any of the liners described above, the liner Connected to the frame by a connection.
  • the present application makes the face contact portion of the pad include an outwardly extending extension portion and an inwardly extending inner extension portion such that the inner extension portion of the lower surface contact portion of the patient's face can abut against When supporting the supporting portion, this can not only form a sealing point at the abutment point, It is also possible to form two sealing areas on both sides of the abutment point, thereby ensuring a stable sealing state.
  • the present application uses a thin film material to form a facial contact portion, which can effectively fill an irregular or uneven surface of the face under the action of gas pressure in the cavity of the respiratory mask, thereby ensuring a reliable seal. Therefore, the same sealing effect can be achieved by the support force required by the prior art.
  • due to the cushioning action of the face contact portion even if the mask is moved during use, it is usually only the relative motion between the support portion and the face contact portion rather than the relative movement of the face contact portion and the patient's face, and thus has a strong Resistance to exercise.
  • the novel pad provided by the present application is not only simple to manufacture, but also convenient to clean, and more importantly, it can safely and reliably provide a stable seal to the patient's face under a small facial contact force, thereby minimizing leakage and simultaneously making Comfort can also be improved to make the patient's treatment process easier.
  • FIG. 1 is a perspective view of a respiratory mask in accordance with a first set of embodiments of the present application
  • FIG. 2 is a cross-sectional view of a pad in accordance with a first set of embodiments of the present application
  • Figure 3 is a rear elevational view of the gasket of Figure 2;
  • Figure 4 is a cross-sectional view of the liner taken along the arrow M in Figure 3;
  • Figure 5 is a cross-sectional view of the pad of Figure 4 in contact with the face of the patient in use;
  • 6a-6c are partial cross-sectional views of a pad in accordance with one of the first set of embodiments of the present application.
  • Figure 7 is a longitudinal cross-sectional view of a respiratory mask in accordance with another embodiment of the first set of embodiments of the present application, wherein the elbow assembly is removed;
  • Figure 8 is a longitudinal cross-sectional view of a respiratory mask in accordance with yet another embodiment of the first set of embodiments of the present application, wherein the elbow assembly is removed;
  • Figure 9 is a perspective view of a respiratory mask in accordance with a second set of embodiments of the present application.
  • Figure 10 is a cross-sectional view of a pad in accordance with a second set of embodiments of the present application.
  • Figure 11 is a cross-sectional view of the liner of Figures 9-10 cut in a direction similar to arrow M in Figure 3;
  • Figure 12 is a cross-sectional view of the pad of Figure 11 in contact with the face of the patient in use.
  • a pad for a respiratory mask (hereinafter referred to as a pad) is provided.
  • a pad for a respiratory mask
  • the embodiment of the present application will first briefly describe a breathing mask using the pad.
  • the nasal mask type breathing mask shown in the drawings is merely exemplary, and the gasket provided by the embodiment of the present application is not limited to the nasal mask type breathing mask, and can also be applied to the nose and mouth.
  • Breathing masks such as a cover type or a full face mask type.
  • the respiratory mask 100 can include a frame (also referred to as a mask body) 110, a cushion 120, a forehead Support member 130 and elbow assembly 140.
  • the respiratory mask 100 may not include one or two of the components, such as not including the forehead support 130.
  • the gasket 120 is mounted on the frame 110.
  • the frame 110 can cooperate with the cushion 120 to form a patient cavity that houses the nose or nose of the patient.
  • the liner 120 may also separately form the patient cavity, which in this embodiment may support the liner 120 on the exterior of the liner 120.
  • the gasket 120 may be fixedly or detachably coupled to the frame 110. In use, the pad 120 will contact the patient's face (including the cheeks, bridge of the nose, upper or lower mouth, etc.) to form a seal to allow the patient cavity to communicate with the patient's nasal cavity or nose and mouth.
  • the frame 110 may be made of a rigid material or may also be made of a flexible material.
  • Pad 120 is preferably made of a flexible material.
  • the above rigid material may be plastic, alloy, etc., and the flexible material may be silica gel, gel, foam, air bag, textile, or the like.
  • the liner 120 can be made of a soft, deformable material such as silica gel. Additionally, the liner 120 can be formed from other suitable biocompatible materials.
  • the liner 120 can be elastic after being formed.
  • the shape of the frame 110 and the cushion 120 is not limited to the general triangular shape shown in FIG. 1 as viewed from the front of the respiratory mask 100, and may be pear-shaped, trapezoidal or the like.
  • the frame 110 and pad 120 can also take any other shape that can be adapted to the shape of the mouth and/or nose.
  • the liner 120 can be fabricated by any one-piece molding process, such as injection molding or blow molding.
  • a gas outlet is provided on the frame 110 or the liner 120.
  • the elbow assembly 140 is coupled to the frame 110 or liner 120 through the gas delivery port.
  • a pressure support device e.g., a ventilator
  • the gas supplied to the patient can be any suitable breathing gas known in the art.
  • the above-mentioned gas pipeline can be a corrugated hose commonly used in the art. It can be understood that the embodiment of the present application does not limit the specific gas pipeline.
  • the frame 110 may be provided with a fixing structure such as a buckle, a strap loop or the like for connecting the fixing assembly (not shown in FIG. 1).
  • the fixation assembly is used to secure the respiratory mask 100 in place on the patient's face, which may be a variety of existing headbands.
  • the headband may have a structure that is coupled to the frame 110, such as a buckle, a Velcro strap.
  • the respiratory mask 100 can also include a forehead support 130 that abuts against the forehead of the patient in use.
  • the connection between the forehead support 130 and the frame 110 may be fixed or split, and the split embodiment is achieved, for example, by snapping.
  • the forehead support 130 can include a soft forehead contact.
  • the forehead support 130 can also have adjustment means to adjust the distance from the forehead to ensure adaptation to different facial shapes.
  • orientation terms referred to in the present application are, for example, “front”, “back”, “front”, “back”, “upper”, “lower”, “left”, “right”, “outside”, “Inner” and the like are all relative to an observer facing a patient wearing the respiratory mask 100 and having the head upright. These orientation terms are obtained by viewing the respiratory mask 100 on the side of the elbow assembly 140 with respect to the placement of FIG.
  • the front side refers to the orientation obtained from the side of the curved tube assembly 140 as viewed from the respiratory mask 100
  • the back side refers to the orientation obtained from the side of the cushion 120 as viewed by the respiratory mask 100.
  • Figure 2 shows a cross-sectional view of the liner 120 taken along the plane of the breathing mask of Figure 1;
  • Figure 3 shows a rear view of the liner 120;
  • Figure 4 is a section along the arrow M of Figure 3.
  • a cross-sectional view of the cut liner 120 is obtained.
  • the pad 120 may include a connection portion 210, a face contact portion 220, and a support portion 230.
  • connection portion 210 is for connection to the frame 110 (see FIG. 1) or the elbow assembly of the respiratory mask 100.
  • the connecting portion 210 and the frame 110 or the elbow assembly may be detachably connected, such as a gap fit (as shown in FIG. 8) or an interference fit.
  • the liner 120 may be secured within the gap of the frame 110 throughout the circumference.
  • the liner 120 can be secured within the gap of the frame 110 or elbow assembly at a localized location in the circumferential direction (eg, corresponding to the bridge of the nose, upper lip, and/or lower lip, etc.).
  • the connection portion 210 and the frame 110/bend assembly may also be connected in a non-detachable manner, such as an adhesive connection (as shown in Figure 7), or both may be formed in one shot using a process such as injection molding.
  • the mask contact portion 220 and the connecting portion 210 are disposed to face each other along the longitudinal direction of the spacer 120 (i.e., the extending direction of the center line P-P).
  • the face contact portion 220 is for contacting the face of the patient.
  • the facial contact 220 is primarily used to form a seal with the patient's face.
  • the centerline P-P is perpendicular to the face of the patient when the patient wears the respiratory mask.
  • the support portion 230 is connected between the connection portion 210 and the face contact portion 220.
  • the support portion 230 extends substantially in the extending direction of the center line P-P.
  • the support portion 230 serves on the one hand to form the aforementioned patient cavity and on the other hand to support the mask contact 220.
  • the connecting portion 210, the mask contact portion 220, and the support portion 230 together form an annular gasket 120.
  • annular means that the spacers 120 are joined end to end around the center line P-P, and the spacer 120 is not limited to have an annular shape.
  • the pads 120 and 200 are generally triangular in shape.
  • the liner 120 may also be pear-shaped, trapezoidal or the like as viewed from the front, and thus the liner 120 may also be substantially a pear-shaped ring or a trapezoidal ring or the like.
  • the embodiment of the present application refers to the direction around the center line PP as the circumferential direction of the pad 120; and the direction starting from the center line PP and extending perpendicular to the center line PP is referred to as the lateral direction of the pad 120. .
  • the liner 120 can include an upper region A, a lower region B, and a middle region C, as best shown in FIGS. 2-3.
  • the upper region A of the pad 120 typically contacts the bridge of the patient's nose; the lower region B of the pad 120 typically contacts the upper lip (nasal mask) or lower lip (nose-nose mask) of the patient.
  • Central area C is connected Between the area A and the lower area B.
  • the central region C may include a left side portion and a right side portion that respectively contact the cheeks on the left and right sides of the patient in use.
  • the bridge of the nose, upper lip and lower lip are relatively sensitive areas of force relative to the cheeks.
  • Embodiments of the present application will design different structures for different areas to make the breathing mask more comfortable to wear and have better sealing.
  • the face contact portion 220 may be formed of a thin film.
  • the maximum thickness of the face contact portion 220 is smaller than the minimum thickness of the support portion 230.
  • the thickness of the face contact portion 220 may be 0.3-1.5 mm.
  • the experimental results show that the sealing effect of the thickness of the face contact portion 220 within the preferred range is better. More preferably, the thickness of the face contact portion 220 may be 0.3-0.6 mm, and the thickness of the face contact portion 220 is better in this range. Most preferably, the thickness of the face contact portion 220 may be 0.4 mm.
  • the thin film can have a uniform thickness. However, the thickness of the thin film may also vary for different regions. For example, the thickness of the thin film in most regions may be 0.6 mm, and in a force sensitive region such as the nose region (i.e., in the upper region A), the thickness of the thin film may be small, for example, 0.4 mm.
  • At least a portion of the face contact portion 220 includes an extension portion 221 and an inner extension portion 222, as shown in FIG.
  • the extension portion 221 extends from the support portion 230 toward the outside of the spacer 120.
  • the inner extension portion 222 extends from the outer peripheral side of the extension portion 221 toward the inside of the spacer 120.
  • the at least partial region may include a central region C.
  • the face contact portion 220 extends from the support portion 230 toward the outside of the pad 120 in the central portion C, as shown more clearly in FIGS.
  • the support portion 230 may extend substantially linearly, such as along the shape of the nose.
  • the face contact portion 220 and the support portion 230 are hooked in this cross section. The support of other structures will also be described later.
  • the inner extension 222 has a high point 222a as shown in FIG.
  • the face contact portion 220 when the face contact portion 220 contacts the face of the patient (specifically, when contacting the cheeks on both sides), the face contact portion 220 first contacts the face with respect to the high point 222a of the face, see FIG. Fig. 5 shows a schematic view of the face contact portion 220 before and after contact with the face of the patient in use, wherein the broken line indicates the facial contour of the patient, and the solid line filled with hatching shows the state after the face contact portion 220 is in contact with the patient's face. The solid line that is not filled with hatching shows the natural state in which the face contact portion 220 does not contact the patient's face. As shown in FIG.
  • the high point 222a of the face contact portion 220 is located on the side of the face contact portion 220 facing the user's face. High point 222a first contacts the patient's face and receives the face After the squeezing, the face contact portion 220 is deformed, and the high point 222a gradually approaches the upper portion of the support portion 230, and finally abuts against the upper portion of the support portion 230. Therefore, the high point 222a can also be referred to as an abutment point. Due to the supporting action of the support portion 230, the face contact portion 220 can well maintain the deformed state and form a sealing point at the high point 222a.
  • the inner extension portion 222 is divided into two parts by the high point 222a, that is, the first inner extension portion 222b connected to the extension portion 221 and the second inner extension portion 222c connected to the first inner extension portion 222b, such as Figure 5 shows.
  • the first inner extension portion 222b extends from the high point 222a to the extension portion 221.
  • the second inner extension 222c extends from the high point 222a to the free end of the face contact portion 220.
  • the second inner extension portion 222c is lifted toward the face of the patient by the gas pressure under the action of the face of the patient, and the second inner extension portion 222c can conform to the face shape of the patient, and the patient
  • the facial contact seal forms a stable first sealing area.
  • the region surrounded by the extension portion 221 and the first inner extension portion 222b is filled with positive pressure gas, and when the high point 222a abuts against the upper portion of the support portion 230, the first The inner extension 222b and the outer portion 223 have formed a sealed airbag.
  • the face contact portion 220 is made of a thin film which is subjected to the pressure of the positive pressure gas inside thereof, the first inner extension portion 222b is brought into contact with the patient's face to form a stable second sealing region. A firm seal is achieved by the action of the sealing point, the first sealing area and the second sealing area described above.
  • the movement of the breathing mask during use is a major factor in the destruction of the seal.
  • the embodiment of the present application applies an appropriate supporting force by abutting the face contact portion 220 against the support portion 230 that functions as a support at the cheek region where the pressure is less sensitive.
  • a sealing point can be formed at the abutment point and two sealing regions can be formed on both sides of the abutment point. , thus ensuring a stable sealing state.
  • the support portion 230 does not provide effective support for the face contact portion 220 at certain positions (for example, there are some uneven areas of the patient's face), relying on other support points
  • the role of the face contact portion 220 can also be substantially located.
  • the face contact portion 220 is made of a thin film, it can be pressed against the patient's face by the gas pressure in the patient cavity, and some uneven areas are filled, so that a reliable seal can still be formed. Therefore, the support force required by the embodiment of the present application can be smaller to achieve the same sealing effect.
  • the supporting portion 230 that functions as a support is deformed by an external force (for example, caused by movement of a patient's body or pulling of a ventilation duct, etc.), largely The sealing action of the face contact portion 220 is not affected because the relative movement between the support portion 230 and the face contact portion 220 is generally only the face contact portion 220 and due to the cushioning action of the outer portion 223 forming the airbag.
  • the relative movement of the patient's face which improves the effectiveness of the seal. Therefore, the pad provided by the embodiment of the present application has strong anti-sporting property.
  • the support is mainly carried out in the cheek area which is less sensitive to pressure, and reliable support and sealing in the central region C of the liner 120 is critical, for facial contact in the upper region A and the lower region B.
  • the portion 220 may have the above-described configuration similar to the central portion C, and other configurations commonly used in the prior art may be employed.
  • the support portion 230 may include a pressure support portion 231 and a contact support portion 232 that are connected to each other, see FIGS. 2, 4, and 5.
  • the pressure support portion 231 is connected to the connection portion 210.
  • the function of the pressure support portion 231 is to form a patient cavity and maintain the overall shape of the pad 120, and provide reliable support for the face contact portion 220 in the middle portion C, so that the minimum thickness of the pressure support portion 231 is greater than the maximum thickness of the face contact portion 220.
  • the pressure support portion 231 also needs to have a certain pressure adjustment capability, and from the viewpoint of cost, the thickness of the pressure support portion 231 is not suitable.
  • the pressure support portion 231 may have a thickness of 1.5-8 mm.
  • the thickness of the pressure support portion 231 can provide good shape retention and support ability within this range, and can have a certain pressure adjustment capability by its own elasticity. More preferably, the thickness of the pressure support portion 231 is in the range of 2-4 mm so that the above various capacities of the pressure support portion 231 are combined to maintain an optimum level. Most preferably, the pressure support portion 231 has a thickness of 3 mm.
  • the contact support portion 232 is connected between the pressure support portion 231 and the face contact portion 220. The contact support portion 232 is located at an upper portion of the support portion 230. The contact support portion 232 is a transition portion between the pressure support portion 231 and the face contact portion 220.
  • the thickness of the contact support portion 232 gradually transitions from the thickness of the pressure support portion 231 to the thickness of the face contact portion 220.
  • the face contact portion 220 is pressed against the contact support portion 232 by the face under the action of the patient's face.
  • the contact supporting portion 232 serves as a transition portion, and can not only support the high point 222a, but also form a firm sealing point between the high point 222a and the patient's face, and also has better elasticity because of its thickness becoming thinner.
  • the patient's face creates an uncomfortable feeling of oppression.
  • the longitudinal extension length of the pressure support portion 231 in the upper region A and the lower region B is smaller than the longitudinal extension length of the pressure support portion 231 in the central region C, and FIG. 2 is preferred.
  • the support portion 230 needs to be abutted on the patient's cheek in the intermediate portion C, and thus the center line of the pressure support portion 231 in the central portion C is extended.
  • the elongation is large.
  • the center line extension length of the pressure support portion 231 in the two regions is short.
  • the entire pad 120 is in the upper region A and the lower region B, and the face contact portion 220 is not in contact with or just in contact with the support portion 230, so that the patient is sensitive The area is less stressed and gives you maximum comfort.
  • the pressure support portion 231 is inclined toward the outside of the pad 120 as shown in FIGS. 2 and 4. This allows the contact support portion 232 to provide a larger area of support to the patient's face to reduce facial pressure.
  • the entire support portion 230 is also provided with a certain pressure regulating capability.
  • the obliquely disposed pressure support 231 can also provide a patient cavity with a suitable space. The patient's cavity can accommodate the patient's nose and/or mouth, etc., and can also provide appropriate ventilation space for the patient's breathing.
  • the angle of inclination of the pressure support portion 231 relative to the centerline P-P of the liner 120 is in the range of 3-15 degrees.
  • the inclination angle is within this range, and the above-described aspects are considered to have the best effect.
  • the inclination of the pressure supporting portion 231 with respect to the longitudinal direction of the spacer 120 (the extending direction of the center line PP)
  • the angle may be a constant value within the above preferred range, or may be a variable within the above preferred range.
  • the inner peripheral surface of the support portion 232 is contacted along the direction from the connecting portion 210 to the face contact portion 220 (i.e., the surface facing the inside of the gasket 120 in the dotted line region in Fig. 4). It is also possible to incline toward the outside of the pad 120, i.e., toward the side indicated by the arrow W. In this way, the contact area of the contact support portion 232 with the human face can be increased, thereby improving the comfort of wearing the patient.
  • the inner peripheral surface may be a flat surface or a curved surface. When the inner peripheral surface is a curved surface, it may be designed as a curved surface suitable for the contour of the face of the face.
  • the face can be obtained with a stable sealing surface and a large supporting area when worn, under the same unit force.
  • the feeling of stress is not obvious, which improves the wearing feeling.
  • the inner peripheral surface of the contact supporting portion 232 may be a circular arc that protrudes toward the inside of the spacer 120.
  • the inner circumferential surface of the contact support portion 232 protrudes toward the inside of the gasket 120 such that a dot corresponding to the inner circumferential surface is located outside the gasket 120.
  • the contact support portion 232 can be made It has a large area to fit the curve of the human face, and at the same time, the high point 211 can be reliably supported, so that both comfort and sealing can be achieved at the same time.
  • a preferred pad 120' in accordance with another embodiment of the present application is provided.
  • the same or similar portions in FIG. 6a as those in FIGS. 2-5 are given the same reference numerals, and the same or similar portions will not be described in detail in the embodiments of the present application.
  • the pad 120' differs from the pad 120 in that it contacts the support portion 232'.
  • the inner peripheral surface of the contact support portion 232' facing the inside of the spacer 120 extends in the lateral direction from the spacer 120 (the direction perpendicular to the center line P-P).
  • the inner peripheral surface of the contact support portion 232' extends substantially in the horizontal direction.
  • Figures 6b and 6c also provide two other preferred pads 120" and 200"'.
  • Pads 120" and 200"' are substantially identical to pad 120 except for their face contacts 220" and 220"'.
  • the facial contact portion 220" is modified such that the portion facing the patient's face is relatively smooth, and there is no significant protruding high point.
  • the facial contact portion 220" in a certain region is simultaneously contacted at the same time.
  • the technical effects mentioned above can also be achieved.
  • the portion of the inner extension portion 222"' located inside the abutment point 221"' is curved toward the side away from the support portion 230 (upward) ).
  • the thin film structure of the inner extension portion 222"' can more closely conform to the patient's face.
  • Other components of the pads 120" and 120"', such as the support portion 230, are the same as those of the above embodiment, and therefore will not be described again.
  • the above configuration of the face contact portions 220" and 220"' can be used in conjunction with various embodiments mentioned herein. Those skilled in the art can select the shape and configuration of the face contact portion and the contact support portion as needed.
  • the connecting portion 210 may include a connecting portion 211 and a bent portion 212.
  • the connecting section 211 is for connection to a breathing mask, in particular to a frame 110 (see Fig. 1) of the respiratory mask.
  • the lateral dimension of the connecting section 211 is smaller than the lateral dimension of the support portion 230.
  • the lateral dimension of a component refers to the distance of the component to the centerline P-P.
  • the lateral dimension of the connecting section 211 refers to the distance of the connecting section 211 to the center line P-P; and the lateral dimension of the supporting section 230 refers to the distance of the supporting section 230 to the center line P-P.
  • the bent section 212 is connected between the connecting section 211 and the support portion 230.
  • a boss is formed at the bottom of the support portion 230.
  • the bent section 212 may extend substantially along the lateral direction of the liner 120, or may be along the transverse direction Extending in a direction that is at an angle to the direction.
  • the bent section 212 extends along the lateral direction of the liner 120.
  • the support portion 230 has a large adjustment margin along both directions of the center line P-P.
  • the lateral width of the bend section 212 in the upper region A and the lower region B is greater than the lateral width of the bend segment 212 in the intermediate region C, as best shown in FIG.
  • the lateral width of the bent section 212 refers to the length D of the bent section 212 extending in the lateral direction, as shown in FIG.
  • the area corresponding to the bridge of the nose and the upper lip/lower lip is a force-sensitive area. In these two areas, the lateral width of the bending section 212 is large, which can well adjust the supporting force applied by the support part 230 to the face contact part 220, avoiding The support portion 230 acts directly on the nose bridge and the upper lip/lower lip of the patient, resulting in poor comfort.
  • the lateral width of the bent section 212 gradually decreases from the upper area A and the lower area B to the intermediate area C.
  • the adjustment ability of the bending section 212 gradually becomes smaller from the upper area A and the lower area B to the intermediate area C, and when somewhere in the intermediate area C, the lateral width of the bending section 212 has gradually decreased to be equal to or close to zero.
  • the force provided by the support portion 230 acts more directly on the face contact portion 220, and therefore, the face contact portion 220 can be well supported at the cheek. Therefore, when the patient's body moves, such as turning over in a sleep, the stability of the mask is increased, the force on the sensitive area of the face is reduced, and the wearing comfort is improved.
  • the maximum lateral width of the bend section 212 in the upper region A is 3-8 mm. More preferably, the maximum lateral width of the bend section 212 in the upper region A is 5-7 mm. Most preferably, the maximum lateral width of the bend section 212 in the upper region A is 6 mm. In another preferred embodiment, the maximum lateral width of the bend section 212 in the lower region B is 2-7 mm. More preferably, the maximum lateral width of the bend section 212 in the lower region B is 4-6 mm. Most preferably, the maximum lateral width of the bend section 212 in the lower region B is 5 mm.
  • the maximum lateral width of the bend section 212 in the upper region A is greater than in the lower region B.
  • the maximum lateral width is such that the nose bridge portion has a strong stress adjustment capability.
  • the maximum lateral width selected within the above preferred ranges can achieve the object of the present application and achieve the desired effect.
  • the bend section 212 may have a thickness of from 0.4 to 2 mm, more preferably from 0.7 to 1.8 mm, further preferably from 1.0 to 1.4 mm, and most preferably from 1.2 mm. Through experiment, the thickness of the bending section 212 The better the range is selected, the better the effect is.
  • the contact support portion 232 of the support portion 230 has a single layer structure, and the contact support portion 1232 of the laminate structure in the second group of embodiments will be described below, as shown in FIGS. 9-12.
  • the same or similar portions in FIGS. 9-12 as those of the previous group embodiment are given the same reference numerals, and the same or similar portions will not be described in detail in the present application.
  • the pad 1120 shown in FIGS. 9-12 differs from the pad 120 in a support portion 1230 that can include a pressure support portion 1231 and a contact support portion 1232. The difference is mainly concentrated on the contact support portion 1232.
  • the contact support portion 1232 has a laminated structure, as shown in FIGS. 10-11, for example, the contact support portion 1232 may have a laminated structure in the central portion C and the lower portion B, and may have a A set of embodiments or the same single layer structure of the prior art.
  • the contact support portion 1232 of the laminated structure may include a first contact support portion 1232a and a second contact support portion 1232b, as shown in FIGS. 11-12.
  • the first contact support portion 1232a extends from the pressure support portion 1231 toward the inside of the spacer 1120 to form a first bend.
  • the second contact support portion 1232b extends from the first contact support portion 1232a toward the outside of the spacer 1120 to the face contact portion 220, and a groove 1233 is formed between the first contact support portion 1232a and the second contact support portion 1232b, that is, the second bending.
  • the face contact portion 220 first extends outwardly to extend inside the steering to form a third bend. therefore.
  • the contact support portion 1232 and the face contact portion 220 form a substantially S-shaped shape.
  • the contact support portion 1232 of the laminated structure supports the face contact portion 220 in use.
  • the face contact portion 220 is similar to the first set of embodiments and includes an extension portion 221 and an inner extension portion 222.
  • the extension portion 221 extends from the outer peripheral side of the second contact support portion 1232b toward the outside of the spacer, and the abutting point is on the second contact support portion 1232b.
  • the respiratory mask when the respiratory mask is fixed to the patient's face, the front surface of the face contact portion 220 is pressed against the patient's face to form a seal, and the back surface of the face contact portion 220 abuts against the first contact support portion 1232a and the second contact.
  • the laminates formed by the support portions 1232b are laminated together to form a sealing point similar to that in the first group of embodiments, and two sealing regions are formed on the inner side and the outer side of the sealing points, so that the patient can be more stable when wearing the mask.
  • the sealing effect prevents gas leakage. Therefore, the support force required by the prior art can be smaller to achieve the same seal.
  • the contact support portion 1232 of the laminated structure absorbs the external force to a greater extent, and the face contact portion 220 and the patient There is no relative movement between the faces, which improves the effectiveness of the seal. Therefore, the second set of embodiments is more resistant to exercise.
  • the laminated structure with grooves has a certain height due to wearing.
  • the elastic support of the degree when the headband is tightened, the support portion 1230 has a large elastic movement interval, so that the facial contact portion 220 is not strongly felt, which improves the wearing feeling. Since the face contact portion 220 abuts against the layered structure, it has a large contact area, and the patient wears it more comfortably and the sealing is very good. And the laminated structure has greater elastic deformation ability than the aforementioned single layer structure.
  • the groove 1233 is gradually opened toward the outside of the spacer 1120, and the groove 1233 has, for example, a flared shape, which is more suitable for forming a seal and molding.
  • the groove 1233 is formed mainly in the middle portion C (ie, the face support region) and the lower region (ie, the upper lip or lower lip contact region) 13.
  • the grooves may also be distributed separately in the central region C.
  • the upper region A i.e., the bridge contact region
  • the face contact portion 220 and the support portion 1230 are integrally hooked to reduce the force on the bridge of the nose.
  • the groove can be controlled by the shape and height of the groove 1233 (the size along the center line extending direction PP, as shown in FIG. 10), and the thickness of the first contact supporting portion 1232a and the second contact supporting portion 1232b, and the like.
  • the groove portion can provide less support to reduce the irritation of the bridge of the nose and upper lip/upper lip, while the non-sensitive face can slightly increase the support force to ensure the sealing force of the pad.
  • the height of the pressure support portion 1231 (the size along the center line extending direction P-P as shown in FIG. 10) as described above.
  • the height of the pressure support portion 1231 in the upper region A and the lower region B may be smaller than its height in the central region C.
  • the second contact support portion 1232b may be formed of a thin film as the face contact portion 220.
  • the thickness of the second contact support portion 1232b may be 0.3 to 1.5 mm, preferably 0.3 to 0.6 mm, and more preferably 0.4 mm.
  • the thickness of the second contact support portion 1232b may coincide with the thickness of the face contact portion 220.
  • the thickness of the first contact support portion 1232a is greater than the thickness of the second contact support portion 1232b.
  • the first contact support portion 1232a is gradually thinned in a direction in which the pressure support portion 1231 to the second contact support portion 1232b extend.
  • the thickness of the first contact support portion 1232a may be between 0.5 and 1.2 mm, preferably 0.6 mm.
  • the first contact support portion 1232a functions more mainly as a support, so the first contact support portion 1232a may have a different thickness in different regions of the face, for example, the thickness in the middle portion C may be greater than in the upper portion.
  • the second contact support portion 1232b is smoothly curved from the first contact support portion 1232a.
  • the bottom of the groove 1233 has a rounded shape to improve the elastic deformation ability of the contact support portion 1232.
  • the radius of curvature of the fillet may be 0.2-2 mm.
  • the application also provides a respiratory mask.
  • the respiratory mask can include any of the frames described above as well as any of the pads described above.
  • the gasket is connected to the frame by a joint.
  • the pad together with the frame forms a patient cavity for the mouth and/or nose for accommodation.

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Abstract

一种用于呼吸面罩（100）的衬垫（120）以及包括该衬垫（120）的呼吸面罩（100）。该衬垫（120）具体包括：连接部（210），用于连接至呼吸面罩（100）的框架（110）或弯管组件；面部接触部（220），用于接触患者的面部，面部接触部（220）由薄层膜形成；以及支撑部（230），其连接在连接部（210）和面部接触部（220）之间。其中，面部接触部（220）至少部分区域具有从支撑部（230）向衬垫（120）的外部延伸的外延部（221）和由外延部（221）的外周侧向衬垫（120）内部延伸的内延部（222）。该衬垫（120）通过面部接触部（220）形成两个密封区域来形成可靠的密封，施加较小的支撑力就能够达到同样的密封效果，进而提高佩戴的舒适性。

Description

用于呼吸面罩的衬垫和呼吸面罩 技术领域
本申请涉及呼吸面罩技术领域，具体地涉及一种用于呼吸面罩的衬垫和呼吸面罩。
背景技术
佩戴呼吸面罩作为非侵入式通气治疗手段已被广泛用于治疗阻塞性睡眠呼吸暂停(OSA，，Obstructive Sleep Apnea)、慢性阻塞性肺气肿(COPD，Chronic Obstructive Pulmonary Disease)等。呼吸面罩通过管路连接至呼吸机，对患者的气道输送持续的压力通气(CPAP，Continuous Positive Airway Pressure)或者变化的压力通气，例如随着患者呼吸周期变化的双水平压力通气或随着患者监控情况而变化的自动调压通气。这种压力支持的疗法还通常被用于如阻塞性睡眠低通气、上呼吸道阻力综合症(UARS，Upper Airway Resistance Syndrome)或充血性心力衰竭等疾病。
目前的呼吸面罩通常包括框架和衬垫。呼吸面罩通过例如头带的固定装置固定在患者的面部时，衬垫接触患者的面部，与患者的面部形成密封的腔体。现有的通气治疗通常是长时间的，患者经常要整夜的佩戴呼吸面罩。基于此，呼吸面罩要尽可能的舒适，并且密封要尽可能的稳固，而这两项要求都与衬垫有关。如果患者感觉佩戴舒适度不够，就可能拒绝治疗。如果密封度不够，则可能引起气体的泄露，一方面导致压力低于治疗值，使治疗失效；另一方面，泄露的气流有可能会冲击患者的面部，尤其在敏感的鼻梁或者眼部，也会引起不舒适，导致患者拒绝治疗。
现有的衬垫根据其结构主要分为双层膜衬垫和单层膜衬垫两类。其中，上述双层膜衬垫通常包括上下分层的密封单元跟支撑单元。双层膜衬垫技术的缺点在于其制造复杂，成本昂贵，清洗不便，这些都是单层膜衬垫相对其的优点。但现有的单层膜衬垫技术的问题在于其一方面舒适度是有限的，另一方面容易发生泄露。单层膜衬垫即支撑单元跟密封单元是一体的， 密封的问题主要取决于衬垫跟面部的接触部分的受力情况。如果为了获得稳固密封，则需要加大衬垫与面部的接触压力，通常通过拉紧头带来实现，这会使患者脸部的接触应力超出面部承受的限度，从而可能出现勒痕，红斑，甚至溃疡。如果减少面部相对于衬垫的受力，则又可能会导致气体发生泄露，引起治疗失效。
发明内容
为了解决现有技术中的单层膜衬垫的密封性和舒适度的问题，本申请提供一种用于呼吸面罩的衬垫以及具有该衬垫的呼吸面罩。
根据本申请的一个方面，提供了一种用于呼吸面罩的衬垫，所述衬垫包括：连接部，用于连接至呼吸面罩的框架或弯管组件；面部接触部，用于接触患者的面部，所述面部接触部由薄层膜形成；以及支撑部，其连接在所述连接部和所述面部接触部之间，其中，所述面部接触部至少部分区域具有从所述支撑部向所述衬垫的外部延伸的外延部和由所述外延部的外周侧向所述衬垫内部延伸的内延部。
优选地，所述内延部具有高点，以所述高点为界将所述内延部分成与所述外延部连接的第一内延部和与所述第一内延部连接的第二内延部；在所述患者的面部作用下，所述内延部的高点抵靠在所述支撑部上。
优选地，在所述患者的面部作用下，所述第一内延部与所述外延部形成封闭的气囊，且所述第一内延部与所述患者的面部接触密封形成第二密封区域；在所述患者的面部作用下，所述第二内延部朝向所述患者的面部翘起并与所述患者的面部接触密封形成第一密封区域。
优选地，所述面部接触部的最大厚度小于所述支撑部的最小厚度。
优选地，所述支撑部包括彼此连接的压力支撑部和接触支撑部，其中，所述压力支撑部连接至所述连接部，所述压力支撑部用于形成所述衬垫的患者腔体；且其中，所述接触支撑部连接至所述面部接触部，所述接触支撑部为所述压力支撑部和所述面部接触部之间的过渡部，在所述患者的面部作用下，所述面部接触部抵靠在所述接触支撑部上。
优选地，沿所述连接部至所述面部接触部的方向，所述压力支撑部和/或所述接触支撑部朝所述衬垫的外部倾斜。
优选地，所述压力支撑部相对于所述衬垫的纵向的倾斜角度为3-15度。
优选地，所述接触支撑部的内周表面为朝所述衬垫的内部凸出的圆弧。
优选地，所述接触支撑部至少部分区域包括第一接触支撑部和第二接触支撑部，所述第一接触支撑部从所述压力支撑部朝向所述衬垫的内部延伸，所述第二接触支撑部从所述第一接触支撑部朝向所述衬垫的外部延伸至所述面部接触部，以在所述第一接触支撑部和所述第二接触支撑部之间形成沟槽。
优选地，在所述患者面部的作用下，所述第二接触支撑部叠压在所述第一接触支撑部上。
优选地，所述第二接触支撑部由薄层膜形成，或者/以及所述第一接触支撑部的厚度从所述压力支撑部到所述第二接触支撑部延伸的方向上逐渐变薄。
优选地，所述沟槽朝向所述衬垫的外部渐开。
优选地，所述第二接触支撑部从所述第一接触支撑部圆滑地弯曲，以使所述沟槽的底部为圆角。
优选地，所述连接部包括：用于连接至呼吸面罩的连接段，所述连接段的横向尺寸小于所述支撑部的横向尺寸；和折弯段，所述折弯段连接在所述连接段和所述支撑部之间。
优选地，沿着所述衬垫的周向方向，所述衬垫包括上部区域、下部区域和连接在所述上部区域和所述下部区域之间的中部区域，从所述上部区域和所述下部区域到所述中间区域，所述折弯段的横向宽度逐渐减小。
根据本申请的另一方面，提供了一种呼吸面罩，包括：框架，所述框架主体具有用于连接至弯管的输气口；以及如上所述的任一种衬垫，所述衬垫通过连接部连接至所述框架。
本申请通过将衬垫的面部接触部制作成包括先向外延伸的外延部和再向内延伸的内延部，使得在患者面部的作用下面部接触部的内延部可以抵靠在起到支撑作用的支撑部上时，这样不仅可以在抵靠点处形成密封点， 而且还可以在抵靠点的两侧形成两个密封区域，从而保证了稳固的密封状态。
并且，本申请采用薄层膜材料来形成面部接触部，可以在呼吸面罩的空腔内气体压力的作用下对面部不规则或不平整的区域进行有效填充，进而保证可靠的密封。所以，较之现有技术需要的支撑力可以小一些而达到同样的密封效果。此外，由于面部接触部的缓冲作用，即使面罩在使用过程中被移动，通常也只是支撑部与面部接触部之间的相对运动而不是面部接触部和患者面部的相对运动，因此具有较强的抗运动性。由此可见，本申请提供的该新型衬垫，不但制造简单，清洗方便，更重要在于在较小的面部接触力下能够安全可靠地给患者面部提供稳固的密封，使泄露最小化，同时使舒适度也能得到改善，让患者的治疗过程更加的轻松。
在发明内容中引入了一系列简化形式的概念，这将在具体实施方式部分中进一步详细说明。本申请内容部分并不意味着要试图限定出所要求保护的技术方案的关键特征和必要技术特征，更不意味着试图确定所要求保护的技术方案的保护范围。
以下结合附图，详细说明本申请的优点和特征。
附图说明
本申请的下列附图在此作为本申请的一部分用于理解本申请。附图中示出了本申请的实施方式及其描述，用来解释本申请的原理。在附图中，
图1为根据本申请的第一组实施例的呼吸面罩的立体图；
图2为根据本申请的第一组实施例的衬垫的剖视图；
图3为图2中的衬垫的后视图；
图4为沿图3中的箭头M剖切的衬垫的剖视图；
图5为沿图4中的衬垫在使用中与患者的面部接触的剖视图；
图6a-6c为根据本申请的第一组实施例中的一个实施例的衬垫的局部剖视图；
图7为根据本申请的第一组实施例中的另一个实施例的呼吸面罩的纵向剖视图，其中去除了弯管组件；
图8为根据本申请的第一组实施例中的又一个实施例的呼吸面罩的纵向剖视图，其中去除了弯管组件；
图9为根据本申请的第二组实施例的呼吸面罩的立体图；
图10为根据本申请的第二组实施例的衬垫的剖视图；
图11为沿类似于图3中箭头M的方向剖切图9-10中的衬垫的剖视图；以及
图12为沿图11中的衬垫在使用中与患者的面部接触的剖视图。
具体实施方式
在下文的描述中，提供了大量的细节以便能够彻底地理解本申请。然而，本领域技术人员可以了解，如下描述仅示例性地示出了本申请的优选实施例，本申请可以无需一个或多个这样的细节而得以实施。此外，为了避免与本申请发生混淆，对于本领域公知的一些技术特征未进行详细描述。
根据本申请的一个方面，提供一种用于呼吸面罩的衬垫(以下简称衬垫)。为了能够准确、完整地理解该衬垫，本申请实施例将首先对采用该衬垫的呼吸面罩进行简单描述。可以理解的是，附图中所示出的鼻罩型呼吸面罩仅为示例性的，本申请实施例提供的衬垫并不限于应用至该鼻罩型呼吸面罩，其还可以应用至口鼻罩型或全脸罩型等的呼吸面罩。
参照图1，示出了根据本申请的第一组实施例的呼吸面罩的立体图，如图1的立体图所示，呼吸面罩100可以包括框架(也称为面罩主体)110、衬垫120、前额支撑件130和弯管组件140。在未示出的其它实施例中，呼吸面罩100可以不包括其中的一个或两个部件，例如不包括前额支撑件130。
衬垫120安装在框架110上。框架110可以与衬垫120共同形成容纳患者的鼻部或者口鼻部的患者腔体。衬垫120也可以单独形成该患者腔体，在此实施例中框架110可以在衬垫120的外部支撑衬垫120。衬垫120可以固定地连接或可拆卸地连接到框架110。在使用时，衬垫120将与患者的脸部(包括脸颊、鼻梁、嘴巴上或下部等)接触，形成密封，以使该患者腔体与患者的鼻腔或者口鼻腔连通。框架110可以由刚性材料制成，或者也可以由柔性材料制成。衬垫120优选地由柔性材料制成。上述刚性材 料可以是塑料、合金等，上述柔性材料可以是硅胶、凝胶、泡沫、气囊、纺织品等。优选地，衬垫120可由例如硅胶的柔软易变形材料制成。此外，衬垫120也可以采用其他的适当生物相容性材料制成。衬垫120在制成后可以具有弹性。从呼吸面罩100的正面观看，框架110和衬垫120的形状不限于图1中所示的大体三角形，还可以为梨形、梯形等等。框架110和衬垫120还可以采用可以与口和/或鼻部形状相适配的任何其他形状。优选地，衬垫120可由任何的一体成型工艺来制造，如注塑模制或吹气模制等。
框架110或衬垫120上设置有输气口。弯管组件140通过该输气口连接至框架110或衬垫120。压力支持设备(例如呼吸机)通过输气管路(图1未示出)与弯管组件140相连，以便输入适当压力的气体进入患者腔体，进而进入患者的气道。供给患者的气体可以是现有技术已知的任何适当的呼吸气体。上述输气管路可以为本领域常用的波纹软管，可以理解，本申请实施例对于具体的输气管路不加以限制。
此外，框架110上还可以设置有卡扣、绑带环等的固定结构，用于连接固定组件(图1未示出)。固定组件用于把呼吸面罩100固定在患者面部的适当位置，可以是现有的各种头带。头带上可以具有与框架110连接的结构，比如扣、带魔术贴的绑带。进一步，为了将呼吸面罩100更加牢固且舒适地固定在患者的面部，呼吸面罩100还可以包括前额支撑件130，前额支撑件130在使用时抵靠在患者的额头上。前额支撑件130与框架110之间的连接可以是固定式的或分拆式的，分拆式的实施例例如通过扣位来实现。前额支撑件130可以包含柔软的额头接触部。该前额支撑件130还可以具有调整装置，以调整与额头距离，保证适应不同面型。
需要说明的是，本申请所涉及的方位术语，例如“正面”、“背面”、“前”、“后”、“上”、“下”、“左”、“右”、“外”、“内”等都是相对于面向佩戴该呼吸面罩100且头部直立的患者的观察者而言的。就图1摆放位置而言，这些方位术语都是通过站在弯管组件140一侧观察该呼吸面罩100得到的。例如，正面是指从弯管组件140一侧观察呼吸面罩100获得的方位；背面是指从衬垫120一侧观察呼吸面罩100获得的方位。
本申请的主旨在于提供了一种新型的衬垫，而呼吸面罩100所包含的其他部件都可以采用本领域已知的构造，因此这里不再进一步详细描述。下面将结合附图对本申请提供的衬垫的多个优选实施例进行详细描述。
图2示出了沿平分图1中的呼吸面罩的平面剖切后得到的衬垫120的剖视图；图3示出了衬垫120的后视图；图4为沿着图3中的箭头M剖切的衬垫120获得的剖视图。如图2-4所示，衬垫120可以包括连接部210、面部接触部220和支撑部230。
连接部210用于连接至呼吸面罩100的框架110(见图1)或弯管组件。连接部210与框架110或弯管组件之间可以采用可拆卸的方式连接，例如间隙装配(如图8所示)或过盈配合等。在图8中，衬垫120可以在整个周向上都卡固在框架110的间隙内。可选地，衬垫120可以在周向上的局部位置(例如对应鼻梁、上唇和/或下唇等)处卡固在框架110或弯管组件的间隙内。连接部210与框架110/弯管组件之间也可以采用不可拆卸的方式连接，例如粘合连接(如图7所示)，或者两者采用例如注塑的工艺一次成型。
面罩接触部220与连接部210沿着衬垫120的纵向(即中心线P-P的延伸方向)相对设置。面部接触部220用于接触患者的面部。面部接触部220主要用于形成与患者面部的密封。所述中心线P-P在患者佩戴该呼吸面罩时垂直于该患者的面部。
支撑部230连接在连接部210和面部接触部220之间。支撑部230大体上沿着中心线P-P的延伸方向延伸。支撑部230一方面用于形成上述患者腔体，另一方面用于支撑面罩接触部220。
连接部210、面罩接触部220和支撑部230一起形成了环状的衬垫120。上述“环状”是指衬垫120围绕中心线P-P首尾相接，而不限定衬垫120必须呈圆环状。在图示实施例中，衬垫120和200大体上呈三角环状。如上文所提到的，衬垫120从正面观察还可以呈梨形、梯形等等，因此衬垫120还可以大体上呈梨形环状或梯形环状等等。基于上述定义，本申请实施例将围绕中心线P-P的方向称为衬垫120的周向方向；并将从中心线P-P起始并垂直于中心线P-P延伸的方向称为衬垫120的横向方向。
沿着衬垫120的周向方向，衬垫120可以包括上部区域A、下部区域B和中部区域C，如图2-图3较佳地示出。在使用中，衬垫120的上部区域A通常接触患者的鼻梁部分；衬垫120的下部区域B通常接触患者的上唇上部(鼻型面罩)或者下唇下部(口鼻型面罩)。中部区域C连接在上 部区域A和下部区域B之间。中部区域C可以包括左侧部分和右侧部分，它们在使用中分别接触患者左右两侧的脸颊。鼻梁、上唇和下唇相对于脸颊为较敏感的受力区域。本申请实施例将针对不同的区域设计不同的结构，以使呼吸面罩佩戴起来更舒适，并且密封性更好。
面部接触部220可由薄层膜形成。面部接触部220的最大厚度小于支撑部230的最小厚度。优选地，面部接触部220的厚度可以为0.3-1.5mm。实验结果表明，面部接触部220的厚度在该优选范围内的密封效果较佳。更优选地，面部接触部220的厚度可以为0.3-0.6mm，面部接触部220的厚度在该范围内的密封效果更佳。最佳地，面部接触部220的厚度可以为0.4mm。薄层膜可以具有均匀的厚度。但是，对于不同区域，薄层膜的厚度也可以是变化的。例如，大部分区域的薄层膜的厚度可以为0.6mm，而在例如鼻梁的受力敏感区域(即上部区域A内)，薄层膜的厚度可以较小，例如为0.4mm。
面部接触部220至少部分区域包括外延部221和内延部222，如图4所示。外延部221从支撑部230朝向衬垫120的外部延伸。内延部222从外延部221的外周侧朝向衬垫120的内部延伸。上述至少部分区域可以包括中部区域C。优选地，面部接触部220在该中部区域C内从支撑部230朝向衬垫120的外部延伸，图4-5较清晰地示出，朝向箭头W所示的一侧延伸；接着，面部接触部220朝向衬垫120的内部(箭头N所示的一侧)弯曲，从而形成了外延部221和内延部222。在沿着衬垫120的中心线P-P的截面(即图4-5所示的截面)内，优选地，支撑部230可以大体上线性地延伸，例如顺着鼻部的形状延伸。在该组实施例中，面部接触部220和支撑部230在该截面内呈钩状。后文还将介绍其它结构的支撑部。
内延部222具有高点222a，如图5所示。在实际应用中，当面部接触部220接触患者的面部时(具体地说，在接触两侧的脸颊时)，面部接触部220上相对于面部的高点222a首先接触面部，参见图5。图5示出了面部接触部220在使用中与患者的面部接触前后的示意图，其中虚线表示患者的面部轮廓，填充有阴影线的实线示出了面部接触部220与患者面部接触后的状态，未填充阴影线的实线示出了面部接触部220未接触患者面部的自然状态。如图5中所示，面部接触部220的高点222a位于面部接触部220的面向使用者面部的一侧。高点222a首先接触患者的面部，受到面部 的挤压后，面部接触部220发生变形，高点222a逐渐靠近支撑部230的上部，最终抵靠在支撑部230的上部上。因此，高点222a也可以称为抵靠点。由于支撑部230的支撑作用，面部接触部220能够很好地保持变形后的状态，并且在高点222a处形成密封点。此外，以高点222a为界，将内延部222分隔成两部分，即与外延部221连接的第一内延部222b和与第一内延部222b连接的第二内延部222c，如图5所示。第一内延部222b从高点222a延伸至外延部221。第二内延部222c从高点222a延伸至面部接触部220的自由端。当采用该衬垫120的呼吸面罩固定于患者面部并进行通气时，可供呼吸的气体沿着图5中所示的箭头方向被送入患者的鼻或口鼻部。由于面部接触部220采用薄层膜制成，因此在患者的面部作用下，第二内延部222c受到气体压力朝向患者的面部翘起，第二内延部222c能够顺应患者的脸型，与患者面部接触密封形成稳固的第一密封区域。高点222a在贴靠至支撑部230的上部之前，外延部221和第一内延部222b包围的区域内会填充正压气体，到高点222a贴靠至支撑部230的上部时，第一内延部222b和外部分223已经形成了密封的气囊。由于面部接触部220采用薄层膜制成，该气囊受到其内部的正压气体的压力作用会使第一内延部222b与患者面部接触密封，从而形成稳固的第二密封区域。通过上述密封点、第一密封区域和第二密封区域的作用，实现了稳固的密封。
实际上，呼吸面罩在使用过程中的移动是导致密封被破坏的主要因素。本申请实施例在压力不太敏感的脸颊区域处，通过将面部接触部220抵靠在起到支撑作用的支撑部230上，来施加适当的支撑作用力。这样，一方面可以减小移动对薄层膜形成的面部接触部220的形状带来的影响，另一方面可以在抵靠点处形成密封点并在抵靠点的两侧形成两个密封区域，从而保证了稳固的密封状态。除此之外，沿着衬垫120的周向，即使支撑部230在某些位置处对面部接触部220不能提供有效支撑(例如患者的面部存在某些不平整的区域)，依靠其他支撑点的作用，也基本能定位面部接触部220。再由于面部接触部220是由薄层膜制成，在患者腔体内气体压力的作用下也能够被压向患者的面部，将某些不平整的区域填充，因此依然能够形成可靠的密封。所以，较之现有技术本申请实施例需要的支撑力可以小一些而达到同样的密封效果。另一方面，当起到支撑作用的支撑部230受到外力(例如由患者身体的移动或通气管道的拉扯等引起的)发生变形时，很大程度上 并不会影响到面部接触部220的密封作用，其原因在于，由于形成气囊的外部分223的缓冲作用，通常只是支撑部230与面部接触部220之间的相对运动而不是面部接触部220和患者面部的相对运动，这样能提高密封有效性。因此，本申请实施例提供的衬垫具有较强的抗运动性。
如上文所提到的，支撑作用主要在对压力不太敏感的脸颊区域实施，实现衬垫120的中部区域C内的可靠支撑和密封是关键，对于上部区域A和下部区域B内的面部接触部220可以具有类似于中部区域C的上述构造，也可以采用现有技术中通常使用的其它构造。
在本申请的一个优选实施例中，支撑部230可以包括彼此连接的压力支撑部231和接触支撑部232，参见图2、图4、和5。压力支撑部231连接至连接部210。压力支撑部231的作用在于形成患者腔体并保持衬垫120的整体形状，在中部区域C内为面部接触部220提供可靠支撑，因此压力支撑部231的最小厚度大于面部接触部220的最大厚度。除此之外，压力支撑部231还需要具有一定的压力调节能力，并且从成本考虑，压力支撑部231的厚度也不宜过后。优选地，压力支撑部231的厚度可以为1.5-8mm。压力支撑部231的厚度在该范围内即能够提供良好的形状保持和支撑能力，又能够通过自身的弹性具有一定的压力调节能力。更优选地，压力支撑部231的厚度在2-4mm范围内，以使压力支撑部231的上述各种能力综合起来保持在最佳水平。最佳地，压力支撑部231的厚度为3mm。接触支撑部232连接在压力支撑部231和面部接触部220之间。接触支撑部232位于支撑部230的上部。接触支撑部232为压力支撑部231和面部接触部220之间的过渡部。接触支撑部232的厚度从压力支撑部231的厚度逐渐过渡到面部接触部220的厚度。优选地，在患者面部的作用下，面部接触部220受面部挤压而抵靠在接触支撑部232上。这样，接触支撑部232作为过渡部，不但能够支撑高点222a，在高点222a与患者的面部之间形成牢固密封点，而且由于其厚度逐渐变薄，也具有较好的弹性，不会对患者的面部造成不适的压迫感。
优选地，压力支撑部231在上部区域A和下部区域B内的纵向延伸长度(即沿着中心线P-P的长度)均小于压力支撑部231在中部区域C内的纵向延伸长度，图2较佳地示出。如前所述，支撑部230在中间区域C内需抵靠在患者的脸颊上，因此压力支撑部231在中部区域C内的中心线延 伸长度较大。而对于与受力较敏感的鼻梁接触的上部区域A和与受力较敏感的上唇/下唇接触的下部区域B，需要较小的接触应力。因此，压力支撑部231在这两个区域内的中心线延伸长度较短。在实际的治疗过程中，患者佩戴具有该衬垫120的呼吸面罩时，整个衬垫120在上部区域A和下部区域B内，面部接触部分220与支撑部230没有接触或者刚刚接触，这样患者敏感区域受力较小，能获得最大的舒适感。
优选地，沿着从连接部210至面部接触部220的方向，压力支撑部231朝衬垫120的外部倾斜，如图2和图4所示。这样可以使接触支撑部232对患者的面部提供更大面积的支撑，以减少面部压迫感。此外，还使整个支撑部230具有一定的压力调节能力。倾斜设置的压力支撑部231还能够提供具有适当空间的患者腔体。该患者腔体能容纳患者鼻子和/或口部等，也能给患者的呼吸提供适当的换气空间。在进一步优选的实施例中，压力支撑部231相对于衬垫120的中心线P-P的倾斜角度(即图4中角α的余角)在3-15度范围内。所述倾斜角度在该范围内，上述各方面综合考虑的效果最佳。需要说明的是，在沿着衬垫120的中心线P-P的截面(即图4中所示的截面)上，压力支撑部231相对于衬垫120的纵向(中心线P-P的延伸方向)的倾斜角度可以是上述优选范围内的一定值，也可以是上述优选范围内的变量。
在本申请的一个优选实施例中，沿着从连接部210至面部接触部220的方向，接触支撑部232的内周表面(即图4中虚线区域内的面向衬垫120的内部的表面)也可以朝衬垫120的外部倾斜，即朝向箭头W所示的一侧倾斜。这样，可以增大接触支撑部232与人脸的接触面积，进而改善患者佩戴的舒适度。所述内周表面可以为平面或曲面。当所述内周表面为曲面时，可以设计成适合人脸的面部轮廓的曲面。当接触支撑部232的所述内周表面向外部倾斜，并配合压力支撑部231也朝向外部倾斜时，佩戴时面部除了可以获得稳固密封，还获得较大的支撑面积，在同样单位作用力下，受力感受不明显，提高了佩戴感受。
进一步，在沿着衬垫120的中心线P-P的截面(即图4中所示的截面)上，接触支撑部232的所述内周表面可以为朝向衬垫120的内部凸出的圆弧。接触支撑部232的所述内周表面朝向衬垫120的内部凸出，使得所述内周表面对应的圆点位于衬垫120的外部。这样，可以使接触支撑部232 具有较大的面积贴合人脸部曲线，同时还能使高点211被可靠地支撑，因此可以同时兼顾舒适度和密封性。
另外优选地，如图6a所示，提供了根据本申请的另一种实施例的优选的衬垫120’。在图6a中与图2-5中相同或相似的部分采用相同的附图标记，并且本申请实施例将不对这些相同或相似的部分进行详细描述。衬垫120’与衬垫120的区别在于接触支撑部232’。在图6a中，接触支撑部232’的面向衬垫120的内部的内周表面沿着从衬垫120的横向方向(与中心线P-P垂直的方向)延伸。在图6a中，接触支撑部232’的所述内周表面大体上沿着水平方向延伸。采用这样的小平面来代替上述实施例中的倾斜面或倾斜弧面，可以使面部接触部220的受力更加稳固。
除此之外，图6b和图6c还提供了另外两种优选的衬垫120”和200”’。衬垫120”和200”’与衬垫120基本相同，除了它们的面部接触部220”和220”’之外。面部接触部220”变型为面向患者面部的部分比较平滑，没有明显的突出的高点，当患者的面部接触面部接触部220”时，会同时与一定区域内的面部接触部220”同时接触，但同样能够实现上文所提到的技术效果。在面部接触部200”’中，内延部222”’的位于抵靠点221”’内侧的部分朝向远离支撑部230的一侧弯曲(上扬)。这样佩戴具有该衬垫120”’的呼吸面罩时，内延部222”’的薄层膜结构可以更紧密地贴合患者面部。衬垫120”和120”’的其它部件，例如支撑部230与上述实施例相同，因此不再赘述。面部接触部220”和220”’的上述构造可以与本申请提到各种实施例结合使用。本领域的技术人员可以根据需要选择面部接触部和接触支撑部的形状和构造。
如图2、图4和图7所示，连接部210可以包括连接段211和折弯段212。连接段211用于连接至呼吸面罩，具体地说，是连接至呼吸面罩的框架110(见图1)。连接段211的横向尺寸小于支撑部230的横向尺寸。某部件的横向尺寸是指该部件到中心线P-P的距离。连接段211的横向尺寸是指连接段211到中心线P-P的距离；且支撑部230的横向尺寸是指支撑部230到中心线P-P的距离。由于连接段211的横向尺寸小于支撑部230的横向尺寸，因此在横向上，连接段211位于支撑部230的内侧。折弯段212连接在连接段211和支撑部230之间。在支撑部230的底部形成凸台。折弯段212可以大体上沿着衬垫120的横向方向延伸，也可以沿着与该横 向方向成一定角度的方向延伸。通过折弯段212的作用，可以自由调节支撑部230的受力高度，给患者佩戴呼吸面罩时提供更大自适应调节空间，进而改善佩戴的舒适度。优选地，折弯段212沿着衬垫120的横向方向延伸。这样，在调节支撑部230的受力高度时，支撑部230沿着中心线P-P的两个方向均具有较大的调节余量。
进一步优选地，折弯段212在上部区域A和下部区域B内的横向宽度均大于折弯段212在中间区域C内的横向宽度，如图2较佳地示出。折弯段212的横向宽度是指折弯段212在横向方向上延伸的长度D，见图4。对应鼻梁和上唇/下唇的区域为受力敏感区域，在这两个区域内，折弯段212的横向宽度较大可以很好地调节支撑部230对面部接触部220施加的支撑力，避免支撑部230直接作用在患者的鼻梁和上唇/下唇上，导致舒适度变差。更进一步优选地，从上部区域A和下部区域B到中间区域C，折弯段212的横向宽度逐渐减小。这样，折弯段212的调节能力从上部区域A和下部区域B到中间区域C逐渐变小，到中间区域C内的某处时，折弯段212的横向宽度已经逐渐减小至等于或接近零。在折弯段212的横向宽度越小的区域内，支撑部230提供的作用力越直接地作用在面部接触部220上，因此，面部接触部220可以在脸颊处得到很好地支撑。从而，在患者身体移动，如睡梦中翻身等时增加了面罩佩戴的稳定性，减少了面部敏感区域受力，提高佩戴舒适性。
在本申请的一个优选实施例中，折弯段212在上部区域A内的最大横向宽度为3-8mm。更优选地，折弯段212在上部区域A内的最大横向宽度为5-7mm。最佳地，折弯段212在上部区域A内的最大横向宽度为6mm。在另一个优选实施例中，折弯段212在下部区域B内的最大横向宽度为2-7mm。更优选地，折弯段212在下部区域B内的最大横向宽度为4-6mm。最佳地，折弯段212在下部区域B内的最大横向宽度为5mm。考虑到鼻梁相对于上唇和下唇为更敏感的受力区域，因此，在设计衬垫120的过程中，可以考虑使折弯段212在上部区域A内的最大横向宽度大于在下部区域B内的最大横向宽度，以使鼻梁部分具有较强的应力调节能力。当然，在上述优选范围内选择的最大横向宽度都能够实现本申请的目的，并达到理想的效果。在又一个优选实施例中，折弯段212的厚度可以为0.4-2mm，较优选地为0.7-1.8mm，进一步优选地为1.0-1.4mm，最佳地为1.2mm。通过实验，折弯段212的厚度 在越优选的范围内选取，效果越佳。
第一组实施例中，支撑部230的接触支撑部232为单层结构，下面将介绍第二组实施例中叠层结构的接触支撑部1232，如图9-12所示。在图9-12中与前组实施例相同或相似的部分采用相同的附图标记，并且本申请将不对这些相同或相似的部分进行详细描述。图9-12所示的衬垫1120与衬垫120的区别在于支撑部1230，支撑部1230可以包括压力支撑部1231和接触支撑部1232。区别主要集中在接触支撑部1232。
接触支撑部1232至少部分区域具有叠层结构，如图10-11所示，例如在中部区域C和下部区域B内接触支撑部1232可以具有叠层结构，而在上部区域A内可以具有与第一组实施例或现有技术相同的单层结构。叠层结构的接触支撑部1232可以包括第一接触支撑部1232a和第二接触支撑部1232b，如图11-12所示。第一接触支撑部1232a从压力支撑部1231朝向衬垫1120的内部延伸，形成第一弯曲。第二接触支撑部1232b从第一接触支撑部1232a朝向衬垫1120的外部延伸至面部接触部220，在第一接触支撑部1232a和第二接触支撑部1232b之间形成沟槽1233，即第二弯曲。如上所述的，面部接触部220先向外部延伸在转向内部延伸，形成第三弯曲。因此。在图9所示的截面内，接触支撑部1232与面部接触部220形成了近似S形的形状。该叠层结构的接触支撑部1232在使用时对面部接触部220起到支撑作用。面部接触部220与第一组实施例相类似，包括外延部221和内延部222。外延部221从第二接触支撑部1232b的外周侧朝衬垫的外部延伸，抵靠点在第二接触支撑部1232b上。
这样，当呼吸面罩固定于病人面部通气时，面部接触部220的正面受到气体压力能够紧贴在病人面部形成密封，面部接触部220的背面则贴靠在第一接触支撑部1232a和第二接触支撑部1232b叠压在一起形成的叠层上，首先形成类似于第一组实施例中的密封点，并在密封点的内侧和外侧形成两个密封区域，能使患者佩戴面罩时获得更加稳固的密封效果，防止气体的泄露。所以较之现有技术需要的支撑力可以小一些而达到同样密封。另一方面，当支撑部1230受外力变形时，如病人身体的移动，通气管道的拉扯等，叠层结构的接触支撑部1232更大程度地吸收了外力而变形，而面部接触部220与患者面部之间不发生相对运动，这样能提高密封有效性。所以，第二组实施例的抗运动能力更强。此外，带有沟槽的叠层结构由于佩戴时形成具有一定高 度的弹性支撑，当拉紧头带时支撑部1230有较大的弹性运动区间，使得面部接触部220受力感受不明显，提高了佩戴感受。由于面部接触部220抵靠在层状结构上，因此具有较大的接触面积，患者佩戴起来会更加舒适并且密封性非常好。并且相比于前述单层结构来说，该叠层结构具有更大的弹性形变能力。
优选地，在图11所示的截面内，沟槽1233朝向衬垫1120的外部渐开，沟槽1233例如具有喇叭开口形，更加适于形成密封和模制成型。在图示实施例中，沟槽1233主要形成在中部区域C(即面部支撑区域)和下部区域(即上唇或下唇接触区域)13。可选地，该沟槽也可以单独分布在中部区域C。上部区域A(即鼻梁接触区域)优选地不设置沟槽支撑，而是使面部接触部220和支撑部1230整体上呈钩状，以此来减少鼻梁受力。另外，可以通过沟槽1233的形状及高度(沿中心线延伸方向P-P的尺寸，如图10所示)、以及第一接触支撑部1232a和第二接触支撑部1232b厚度等来控制沟槽所提供支撑力的大小，这样就可以可控的将支撑力分布在面接触部分的不同区域。比如，在上部区域和下部区域，沟槽部分可以提供较小支撑力，减少鼻梁、上唇/上唇受到的刺激，而在非敏感的面部可以稍微增大支撑力来保证衬垫的密封力。除此之外，为了控制在面部不同区域内的压力分布，还可以如前文所述地调节压力支撑部1231的高度(沿中心线延伸方向P-P的尺寸，如图10所示)。例如，在上部区域A和下部区域B内压力支撑部1231的高度可以小于其在中部区域C内的高度。
优选地，第二接触支撑部1232b可以如面部接触部220一样由薄层膜形成。第二接触支撑部1232b的厚度可以为0.3-1.5mm，优选地为0.3-0.6mm，更优选地为0.4mm。第二接触支撑部1232b的厚度可以与面部接触部220的厚度一致。第一接触支撑部1232a的厚度大于第二接触支撑部1232b的厚度。第一接触支撑部1232a从压力支撑部1231到第二接触支撑部1232b延伸的方向上逐渐变薄。第一接触支撑部1232a的厚度可以在0.5-1.2mm之间，优选为0.6mm。两者中，第一接触支撑部1232a更主要地起到支撑作用，因此在面部的不同区域内，第一接触支撑部1232a可以具有不同的厚度，例如在中部区域C内的厚度可以大于在上部区域A和下部区域B内的厚度。由于第二接触支撑部1232b为薄层膜，且第一接触支撑部1232a越靠近第二接触支撑部1232b越薄，因此在使用时能够贴靠在第一接触支撑部1232a上，并且使 两者形成向患者面部凸起的弧面支撑，因此佩戴更加舒适。
优选地，在图9所示的截面内，第二接触支撑部1232b从第一接触支撑部1232a圆滑地弯曲。沟槽1233的底部呈圆角状，以此来提高接触支撑部1232的弹性形变能力。优选地，该圆角的曲率半径可以为0.2-2mm。
本申请还提供一种呼吸面罩。该呼吸面罩可以包括上文所述的任一种框架以及上文所述的任一种衬垫。衬垫通过连接部连接至所述框架。衬垫与框架一起形成了用于容纳的口和/或鼻的患者腔体。对于它们所包含的各个部件、结构可以参照上文相应部分的描述。
本申请已经通过上述实施例进行了说明，但应当理解的是，上述实施例只是用于举例和说明的目的，而非意在将本申请限制于所描述的实施例范围内。此外本领域技术人员可以理解的是，本申请并不局限于上述实施例，根据本申请的教导还可以做出更多种的变型和修改，这些变型和修改均落在本申请所要求保护的范围以内。本申请的保护范围由附属的权利要求书及其等效范围所界定。

Claims (16)

  1. 一种用于呼吸面罩的衬垫，其特征在于，所述衬垫包括：
    连接部，用于连接至呼吸面罩的框架或弯管组件；
    面部接触部，用于接触患者的面部，所述面部接触部由薄层膜形成；以及
    支撑部，其连接在所述连接部和所述面部接触部之间；
    其中，所述面部接触部至少部分区域具有从所述支撑部向所述衬垫的外部延伸的外延部和由所述外延部的外周侧向所述衬垫内部延伸的内延部。
  2. 如权利要求1所述的衬垫，其特征在于，
    所述内延部具有高点，以所述高点为界将所述内延部分成与所述外延部连接的第一内延部和与所述第一内延部连接的第二内延部；
    在所述患者的面部作用下，所述内延部的高点抵靠在所述支撑部上。
  3. 如权利要求2所述的衬垫，其特征在于，
    在所述患者的面部作用下，所述第一内延部与所述外延部形成封闭的气囊，且所述第一内延部与所述患者的面部接触密封形成第二密封区域；
    在所述患者的面部作用下，所述第二内延部朝向所述患者的面部翘起并与所述患者的面部接触密封形成第一密封区域。
  4. 如权利要求1所述的衬垫，其特征在于，
    所述面部接触部的最大厚度小于所述支撑部的最小厚度。
  5. 如权利要求1所述的衬垫，其特征在于，所述支撑部包括彼此连接的压力支撑部和接触支撑部；
    其中，所述压力支撑部连接至所述连接部，所述压力支撑部用于形成所述衬垫的患者腔体；且
    所述接触支撑部连接至所述面部接触部，所述接触支撑部为所述压力支撑部和所述面部接触部之间的过渡部，在所述患者的面部作用下，所述面部接触部抵靠在所述接触支撑部上。
  6. 如权利要求2所述的衬垫，其特征在于，沿所述连接部至所述面部接触部的方向，所述压力支撑部和/或所述接触支撑部朝所述衬垫的外部倾斜。
  7. 如权利要求6所述的衬垫，其特征在于，所述压力支撑部相对于所述衬垫的纵向的倾斜角度为3-15度。
  8. 如权利要求5所述的衬垫，其特征在于，所述接触支撑部的内周表面为朝所述衬垫的内部凸出的圆弧。
  9. 如权利要求5所述的衬垫，其特征在于，所述接触支撑部至少部分区域包括第一接触支撑部和第二接触支撑部，所述第一接触支撑部从所述压力支撑部朝向所述衬垫的内部延伸，所述第二接触支撑部从所述第一接触支撑部朝向所述衬垫的外部延伸至所述面部接触部，以在所述第一接触支撑部和所述第二接触支撑部之间形成沟槽。
  10. 如权利要求9所述的衬垫，其特征在于，在所述患者面部的作用下，所述第二接触支撑部叠压在所述第一接触支撑部上。
  11. 如权利要求9所述的衬垫，其特征在于，所述第二接触支撑部由薄层膜形成，或者/以及所述第一接触支撑部的厚度从所述压力支撑部到所述第二接触支撑部延伸的方向上逐渐变薄。
  12. 如权利要求9所述的衬垫，其特征在于，所述沟槽朝向所述衬垫的外部渐开。
  13. 如权利要求9所述的衬垫，其特征在于，所述第二接触支撑部从所述第一接触支撑部圆滑地弯曲，以使所述沟槽的底部为圆角。
  14. 如权利要求1所述的衬垫，其特征在于，所述连接部包括：
    用于连接至呼吸面罩的连接段，所述连接段的横向尺寸小于所述支撑部的横向尺寸；和
    折弯段，所述折弯段连接在所述连接段和所述支撑部之间。
  15. 如权利要求14所述的衬垫，其特征在于，沿着所述衬垫的周向方向，所述衬垫包括：上部区域、下部区域和连接在所述上部区域和所述下部区域之间的中部区域，从所述上部区域和所述下部区域到所述中间区域，所述折弯段的横向宽度逐渐减小。
  16. 一种呼吸面罩，其特征在于，包括：
    框架，所述框架主体具有用于连接至弯管的输气口；以及
    如权利要求1-15中任一项所述的衬垫，所述衬垫通过连接部连接至所述框架。
PCT/CN2016/111814 2015-12-24 2016-12-23 用于呼吸面罩的衬垫和呼吸面罩 WO2017107991A1 (zh)

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EP3395389A4 (en) 2019-01-02
US20180207384A1 (en) 2018-07-26
EP3395389A1 (en) 2018-10-31
US11160943B2 (en) 2021-11-02

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