Patient interface and headgear

The present invention relates to the improvement of patient interface devices, particularly, but not exclusively, in the use of artificial respiration for treating patients. In particular, the invention relates to interface means and head equipment used to attach interface means to a patient.

Description of the Related Art

Many different airway interface devices that cover the patient's nose and / or boom are known in the art to provide isolation around the nasal and / or mouth areas so that gas can be delivered to the patient for positive pressure inside the interface device.

Interfaces must ensure effective face sealing to minimize the likelihood of breathing gas leaking. In many interface devices, good tightness is often achieved only by causing discomfort to the patient with temporary success and / or by consuming a considerable amount of time to mount the interface device on the patient.

Given the patient's discomfort, this issue is paramount in an intensive medical nursing setting. In such an environment, the patient must wear the interface device continuously for hours, maybe even days. If severe discomfort occurs, the patient will reluctantly tolerate the mask for long periods.

In many constructions, even a good sealant can be temporary due to the inability to effectively isolate when the patient's face is distorted. For example, when the patient is sleeping on the side, the head equipment can be very stressed on one side and loose on the other. Such asymmetric loading can rotate the axis of the interface device relative to the head due to effective head equipment and any associated respiratory torque. Rotating the axis can cause leakage on one side of the interface tool. In addition, a patient sleeping on the side may also feel discomfort due to distorted facial contours (such as in the nose area) about the sealant, further causing leakage.

Finally, in an intensive care setting, the speed at which breathing treatment can be initiated is critical. Therefore, the shape of the head unit, the ability to quickly make sufficient seals, was identified as an area where current forms could be improved.

The essence of the invention

It was found that both the close fit of the interface device to the patient's face and the attachment of the interface device to the patient's head could be improved.

Because the interface can be worn for extended periods of time, such as when sleeping in a hospital 5, it is desirable that comfort is maximized while maintaining sufficient compression of the interface, providing proper placement and proper face sealing, thereby reducing the likelihood of significant leakage. For example, any leakage should preferably be less than about 15 rpm. At the hospital, the patient may not be conscious while wearing the interface device. Additional comfort can also increase patient acceptance of the treatment and lead to better outcomes.

Preferably, the interface device and associated head equipment should be as easy, accurate and removable as possible. It is also desirable that a single head equipment design encompasses a wide range of patient head sizes, shapes, and hair style types, while still being in simple operation. This is particularly important in a hospital where staff constantly place and remove patient interface devices and associated head equipment. It is desirable that the interface tools also cover a variety of face shapes and sizes.

From the patient's point of view, the interface tool should also bring some benefits where possible. For example, the patient may want to wear glasses, so the space above the nose may be important. Also, the patient may want to talk to people, so advances in interface design can increase the ability to be heard without removing the interface tool, and this can be important. In addition, the patient usually wants the interface device to not significantly interfere with the field of view. Thus, a lower profile interface tool is desirable. Finally, from a comfort point of view, the patient wants a form of interface and head unit that minimizes gas leakage to the eyes and has a reduced odor of substances as well as reduced noise levels.

The health care provider impartially wants a well-sealed interface to provide even pressure distribution of the interface to the skin to reduce the likelihood of a focused load or high pressure gradient. Such a feature may reduce the patient's probability of skin irritation. In addition, release of carbon dioxide is desirable to reduce the likelihood of carbon re-inhalation.

The object of the invention is to provide an improved patient interface device and / or an improved head unit for attaching the patient interface device to the patient, or at least to provide a useful choice to the public and medical personnel.

This description, with references to patent descriptions, other external documents, or sources of information, is for discussion. Reference to external documents cannot be construed as recognition that such documents or such sources of information, in any legal form, are known in the art or form part of the general state of the art, unless specifically stated otherwise.

The use of the term "constituting" in this description means "constituting at least in part". Whenever this Statement interprets each statement that includes the term "constituent", this term may include features other than those stated. Related terms such as "encompasses" and "belongs" must be interpreted in the same way.

Some embodiments of the present invention may also be more broadly defined, consisting essentially of the parts, elements, and features set forth in the specification, individually or collectively, and in part or all of two or more parts, elements, or features of the combination, and wherein are specific integers having known equivalents to the prior art to which the present invention pertains, such known equivalents are considered to be incorporated herein by reference in their entirety.

The invention consists of the foregoing and also provides embodiments which are provided by way of example only.

In one aspect, the present invention is an interface device comprising a mask, a head unit, an adjusting line, an upper slider between the adjusting line and the upper part of the mask, a lower sliding link between the adjusting line and the lower part of the mask, a left slider the adjustment line and the left side of the head unit, the right sliding link between the adjustment line and the right side of the head unit, the adjusting line thereby engaging the left side of the head unit and the upper and lower part of the mask and the right side of the head unit and the upper and lower part of the mask by means of a buckle, clip or other adjusting mechanism (directly or indirectly) the trajectory of the line between the first and second parts, including upper, lower, left and right side joints so that the trajectory length of the adjusting line can be varied.

Alternatively, the adjustment line passes through the outside of either the upper part of the mask or the lower part of the mask or both.

In yet another aspect, the head unit comprises an upper left flank mount and a lower left flange mount, an upper right flange mount, and a lower right flange mount, the alignment line extending through both the upper and lower flange mountings of the head unit.

In yet another aspect, the interface means comprises at least two sliding joints between the attachment line and the underside of the mask.

In another aspect, the interface means comprises at least two sliding joints between the attachment line and the upper portion of the mask.

In yet another aspect, the interface means clamps the control line in two locations so that the control line forms a closed loop.

In yet another aspect, the first and second portions of the adjusting line pass through the buckle, and pulling one or both ends through the buckle reduces the loop length and, by sliding the connections to the mask and head equipment, distributes this tension around the loop.

In another aspect, the buckle, clamp, or adjusting mechanism loosens the adjustment line or allows the adjustment line to pass therethrough when the control line tension exceeds the threshold value (the threshold limits the line voltage to the useful voltage range).

Alternatively, the arrangement of the sliding joints on the mask is such that the area projecting over the upper sliding joint of the mask and the projecting area of ​​the mask over the lower sliding joint are substantially equal.

In another perspective, the regulatory line is largely unstretched.

Alternatively, one or more of said sliding joints associated with said mask has a pulley wheel engaging said adjustment line.

In yet another aspect, one or more of said sliding joints associated with said head unit has a pulley wheel engaging said adjustment line.

Alternatively, the control line is fully or partially enclosed within the tube 25 forming said closed loop.

Alternatively, the buckle, collar or other adjusting mechanism shall comprise:

(a) a compressible wedge,

(b) a wedge of the cam,

(c) linear type ratchet mechanism for slide fittings,

(d) Ratchet and relaxing dial.

In another aspect, the present invention comprises an interface device that supplies gas to a patient and has a seal that contacts the wearer's face on the inside, the seal contacts the wearer's mouth and nose, and the outer surface of the interface is formed as a replica of at least one human face. .

In yet another aspect, the outer surface of the interface device is a copy of the human nose.

Alternatively, the seal is a portion of the sealing member consisting of a soft adaptable material, the interface member has a stiffer portion of the outer surface of the interface member, and at least one copy of the human facial features is formed as part of the sealing member.

In yet another aspect, the support member is flexible, and the edges of the support member may conform to the contours of the wearer's face.

Alternatively, the support member has a sealing portion that contacts the face of the wearer and a cover portion that contacts the inside surface of the support member, the sealing portion contacting the inside surface of the support member being a surface that is wholly or nearly entirely provided for the aperture.

In another aspect, the interface means has a connector for sealing the opening of the sealing member.

Alternatively, the sealing member has a radially inwardly projecting sealing flange around substantially the entire circumference of the sealing member, wherein the sealing flanges also contact the face by applying an interface means.

Alternatively, the support member has head unit mounts for holding the interface means to the user.

In yet another aspect, the support member is designed to hold ergonomically fit shapes in the hand.

Alternatively, facial features include the human nose, the sealing member extending over the user's nose and upper cheeks, cheekbones, and the upper circumference of the support member extending across the upper lip below the nose and upward along each nostril and transversely from the nose to each side above the level of the nostrils.

Alternatively, the support member has an opening substantially aligned with the opening of the sealing member, the opening of the support member being larger than the opening of the sealing member.

Alternatively, the support member and the sealing member have a chin portion, the chin portion of the sealing member extending beneath the wearer's chin during use.

In another aspect, the seal is an inflatable seal.

Alternatively, the stiffness of the support member comprises a portion of the bridge extending at least partially above said sealing member in the region of a human nasal copy.

In another aspect, the interface means further comprises a respiratory tube connection opening, said connection opening being mounted in a sealing member.

In another aspect, the present invention comprises a breathing mask comprising a soft adaptive sealing member adapted to cover the wearer's nose and boom and contact with the wearer's face to fit snugly along at least the sealing edge, a support member disposed adjacent and supporting said sealing member, at least the outer portion of the support member has a plurality of replaceable members movable relative to at least the inner portion of the support member.

Alternatively, the inner member of the support member has a hub portion coupled to said seal, and said replaceable members are secured at one end such that they extend outwardly from the inner hub toward the periphery of said seal member.

In another view, the interchangeable elements are flexible with respect to one another.

In another aspect, the respiratory mask comprises an additional support member disposed adjacent and supporting said support member or said sealing member, wherein at least the outer portion of the additional support member has a plurality of replaceable members movable relative to at least the inner portion of said additional support member.

Alternatively, the movement of the replaceable members is mainly forward in the reverse direction relative to the wearer's face when wearing said breathing mask.

Alternatively, one or more of the replacement members further comprise one or more adaptive members associated with the free end of the replacement member.

In yet another aspect, said adaptive member is a compressible bow.

In another aspect, the adaptive member is a shamir elastic rod

In another aspect, the adaptive member is made of compressible foam.

In another aspect, the support member or said additional support member has a semi-rigid stiffening edge which substantially strengthens said support member or said additional support member.

In yet another aspect, said stiffening edge and said direction are substantially aligned with the user's mid sagittal plane when wearing said mask.

In another aspect, the present invention comprises an interface device, substantially as described herein, with reference to any one or more drawings.

In another aspect, the present invention comprises an interface means comprising a mask 30, a head unit connector between said mask and a head unit having an elastic stretch member and a substantially non-stretch member arranged parallel to adjusting the length of the joint stretch member.

In another aspect, said connector is adapted for use stretched from the first side of said mask around the wearer's head from behind to the second side of said mask.

In yet another aspect, the mask has left and right sides and head equipment has left and right sides, said connector comprising a first connector between the left side of the mask and the left side of the head unit and a second connector between the right side of the mask and the right side of the head unit having an elastic stretching element and a substantially non-stretching element arranged in parallel, the first adjusting mechanism adjusting the length of the non-stretching element of the first joint, and the second adjusting mechanism adjusts the length of the non-stretching member of the second connection,

In yet another aspect, the interface means also includes a third connector between the left side of the mask and the left side of the head unit, a fourth connector between the right side of the mask and the right side of the head unit; the third and fourth connections have an elastic stretch member; the mechanism adjusts the length of the non-stretching member of the third joint, and the fourth adjusting mechanism adjusts the length of the non-stretching member of the fourth connection,

In yet another aspect, the first and second connections are connected between the upper portion of the mask and the upper portion of the head unit, and the third and fourth connections are connected between the lower portion of the mask and the lower portion of the head unit.

In yet another aspect, the first and second adjustment mechanisms regulate the length of the non-stretching members of the first and second joints.

In yet another aspect, the third and fourth adjusting mechanisms regulate the length of the non-stretching members of the third and fourth joints.

In yet another view, all adjustment mechanisms are located on the mask.

Alternatively, all adjusting mechanisms are lock-type mechanisms having at least two modes, the first locking mode of which said non-stretching element cannot be lengthened, and the second locking mode of said non-stretching element can be lengthened.

In yet another aspect, the length of said non-stretching member may be reduced when said locking mechanism is in locking mode.

Alternatively, the first and second connectors extend around the user's head from the side and are disposed over the user's ear, while the third and fourth connectors extend around the user's head from the side and are disposed below the user's ear.

Alternatively, the regulatory mechanism is one of the following:

a. friction buckle,

b. stair clasp,

c. sash,

d. ratchet,

e. clamp,

f. fist wedge.

In yet another aspect, the first joint elastic member and the non-stretch member 5 are joined to the mask at a substantially overlapping attachment site, and the second joint elastic member and non-stretch member to the mask overlap substantially at the attachment site.

In yet another aspect, the elastic member of the third joint and the non-stretching member are joined to the mask at a substantially overlapping attachment point, and the elastic member and non-stretch member of the fourth joint are joined to the mask at the substantially overlapping attachment.

Alternatively, the first joint elastic member and the non-stretch member are joined to the head assembly at a substantially overlapping attachment point and the second connector elastic member and the non-stretch member to the head assembly in substantially overlapping attachment location e.

In yet another aspect, the elastic member and the non-stretch member of the third connector are joined to the head unit at a substantially overlapping attachment point, and the elastic member and non-stretch member of the fourth connector are joined to the head assembly at the substantially overlapping attachment.

Alternatively, the elastic stretchable members of the joints may be stretched from about 1.5 times to about 3 times the unstretched length.

In another aspect, the elastic stretchable members of the joints can be stretched up to about 2 times the unstretched length.

In yet another aspect, the length of the elastic members of the joints is not regulated other than by stretching the material.

Alternatively, the tension force exerted by the elastic members of the joints is sufficient to maintain the mask on the wearer's face during installation.

Alternatively, the tensile force exerted by the elastic members of the joints is sufficient to seal the mask during use.

In another aspect, the mask is one of the following:

g. nose mask,

h. mouth mask,

i. mouth and nose mask (full face),

j. nose pads,

k. a nasal mask comprising a nasal catheter,

l. nasal cannula.

Alternatively, the elastic members and the non-stretch members of each respective joint are integrated into one another.

In yet another aspect, the elastic members of each joint have a channel extending substantially their entire length, and the corresponding non-stretching members are disposed within said channel.

In yet another aspect, the non-tensioned members of each respective joint are also formed to resist compressive forces along their length.

In another aspect, the present invention includes an interface device having a mask, a head unit, a connector between a mask and a head unit having a first adjustable mode wherein the length of the joint can be adjusted and a second locking mode wherein the length of the joint cannot be substantially increased.

In yet another aspect, the joint comprises a right lateral joint and a left lateral joint, wherein both the right lateral joint length and the left lateral joint length can be adjusted in the first mode, while the right lateral joint length and the left lateral joint length cannot be substantially increased, in the second locking mode.

In yet another aspect, the length adjustment of the joint is effected via a locking mechanism having at least two modes, wherein the first locking mode cannot extend the length of the joint and the second unlocking mode allows the length of said joint to be extended.

In yet another aspect, the length of said joint may be shortened when the locking mechanism is in the locking mode.

In yet another embodiment, each joint comprises an elastic stretch member configured to maintain a holding force on the wearer's face in the first locking mode.

In yet another aspect, each joint comprises an elastic stretch member configured to maintain a holding force on the wearer's face in the second release mode.

Alternatively, the head equipment is less elongated than the elastic members of the coupling. In yet another aspect, the head equipment is less elongated than the connectors.

In another aspect, the present invention encompasses headgear for use with a mask comprising a first strap configured to hug the user's head from behind and having a lower back, left lateral, right lateral, left and right upper arched, lower the rear, adapted for use on the user's neck, substantially below the occiput, the left and right lateral parts, each extending from the respective side of the lower back, against the patient's ears and the lateral incisors of the incisors, each with an arched portion extending above the respective ear and forward of the user's ears to define the left and right upper margins, and a second strap extending from the apex of the left side arch to the apex of the right side, a third and a fourth strap, extending from the corresponding side of the lower back to the front and below the user's ears, and the fifth and sixth straps extending forward from the respective upper limit.

In yet another aspect, the fifth and sixth straps are connected to the respective lateral upper limit portion so that the total angular orientation of the fifth and sixth straps can move in the sagittal plane.

In yet another aspect, the sagittal planes generally correspond to the respective lateral surfaces of the patient's head.

In yet another aspect, the connections between the fifth and sixth straps and the corresponding lateral upper limit portion rotate about a generally horizontal axis.

In yet another aspect, the second strap comprises a left lateral portion and a right lateral portion disengaged together.

In another aspect, the length of the second strap is adjustable.

In yet another aspect, the first and second straps are formed of a single flat element.

In yet another aspect, said flat member takes the form of a 3D head unit adapted to hug the user's head when the left and right side sections of the second strap are joined together.

In yet another aspect, the first, second, third, and fourth straps are formed of a single, flat element.

In yet another aspect, the third and fourth straps are not formed of a single flat element.

In yet another aspect, the fifth and sixth straps are not formed of a single flat element.

In another aspect, the second strap is made of a single material and is not soft.

In yet another aspect, the first and second straps are made of a rigid and elastic material.

In another aspect, the third and fourth straps are made of a rigid and elastic material.

In yet another aspect, the fifth and sixth straps are made of a rigid and elastic material.

In another aspect, the third and fourth straps are made of soft material.

In another aspect, the fifth and sixth straps are of soft material.

In yet another aspect, the left and right side arch portions are formed of a single elastic material.

In yet another aspect, the widths of the second, third, fourth, fifth and sixth straps are from 10 mm to 30 mm.

In yet another aspect, the width of the first strap at the lower rear is from 10 mm to 30 mm.

In yet another aspect, the width of the first strap at the lower rear is from 10 mm to 50 mm.

In yet another aspect, the thickness of the first, second, third, fourth, fifth and sixth straps is from 0.1 mm to 3 mm.

In yet another aspect, the straps are laminated with a layer of one of the following materials:

m. non-woven polypropylene (PP),

n. non-woven polyethylene (PE),

o. santoprene / polypropylene blend.

In yet another aspect, the third and fourth straps have a reduced width area.

In yet another aspect, the areas of reduced width are adjacent to the lower posterior portion.

In yet another aspect, the fifth and sixth straps have a reduced width area.

In yet another aspect, the reduced width areas of the fifth and sixth straps are adjacent to the upper limit portions.

Alternatively, one or more of the following elements have a laminate structure with at least one soft material:

p. first strap,

q. third or fourth straps,

r. fifth or sixth straps.

In another aspect, the present invention may be said to comprise an interface means comprising:

a mask defining a gas cavity and having left and right sides, head equipment having left and right side straps to connect the left side of the head unit to the left side of the mask, respectively, connecting the right side of the head unit to the right side of the mask; left side strap and 5 second split connection for attachment to right side strap, and no other separating joints are located at the front of the mask on the outer surface.

Alternatively, the head unit further comprises left and right side straps to connect the left side of the head unit to the left side of the mask, the right side of the head unit to the right side of the mask, wherein the mask further has a third separating connector for attachment extra right side strap.

Alternatively, each detachable joint has a projection disposed on the outside of the face of the mask, and both left and right side straps have at least one opening that is sized to accommodate 15 corresponding projections to form the joint.

Alternatively, each projection extends from the face of the mask and has a tip at the far end of the projection that impedes passage through the opening.

In another aspect, the present invention may substantially comprise a mask having a gas cavity with an inner surface, a seal contacting the wearer's face to substantially seal said cavity, a pressure cavity at least partially defined in said gas cavity and a fluid communication with gas inlet. a gas inlet, a diffuser outlet through which gas can flow from a pressure cavity to a gas cavity, and wherein the diffusive outlet is partially defined by a portion of the circumference of said wall.

In another view, said diffuse opening extends substantially along the entire circumference of the wall.

In another aspect, said diffuse opening is less than 10 mm wide.

In another aspect, said diffuse opening is 3 to 6 mm wide.

Alternatively, the wall is configured to direct a gas stream from the inlet to the gas cavity along the periphery of the wall, close to at least a portion of the seal.

In another aspect, said mask further comprises one or more pressure control openings.

Alternatively, the pressure control orifice is located on the body of the mask and extends through the pressure chamber and contacts the flowing medium with the gas cavity.

In another aspect, the seal is an inflatable seal.

In another aspect, the gas inlet is a very flexible short tube for connecting the breathing tube.

Alternatively, the total cross-sectional area of ​​the diffusion orifice is at least twice the gas inlet.

In yet another aspect, the diffuse opening extends substantially along the entire circumference of the septum.

In another aspect, the diffusive orifice is not a continuous orifice extending substantially along the entire circumference of the septum and includes areas along the septum that are closed.

In yet another aspect, the bulkhead has one or more openings.

Alternatively, the mask has one or more flow guiding ribs extending approximately radially from the central region of the septum and projecting from the septum or mask cavity wall.

In another aspect, the present invention comprises a mask having a gas cavity with an inner surface, a seal that contacts the wearer's face to substantially seal said cavity, a flow-acting structure configured to coil the breathing gas into a cyclonic pattern approximately tangentially to the wearer's face. the gas inlet in the flowing medium contacts the flow affecting structure.

In yet another aspect, the flow-affecting structure comprises substantially cylindrical walls extending perpendicular to the face of the mask cavity, substantially a conical wall extending coaxially with the cylindrical wall and defining an approximately annular rotation cavity between the cylindrical wall and the conical wall.

In another aspect, the annular rotation cavity is open to the gas cavity and narrower to the wall of the mask cavity.

In yet another aspect, the gas inlet is located laterally from the center of the annular rotary cavity and configured to direct the gas flow to the annular rotary cavity approximately tangentially.

In another aspect, the mask described above still has a valve prior to suffocation.

In another aspect, the mask described above further comprises one or more pressure control openings.

According to the invention, the breathing interface means comprises an inflatable soft adaptive sealing member adapted to cover the wearer's nose and boom. The sealing member has a sealing portion adapted to contact the wearer's face. The sealing part consists of a twisted perimeter edge and a sealing flange extending inward from the perimeter edge. The sealing flange consists of an expanded surface with one edge joined to the twisted perimeter edge. The support member is attached to the sealing member. The support member is stiffer than the sealing member. The support member has a peripheral edge of the support member. The twisted perimeter edge of the sealing member extends outward beyond the perimeter edge of the support member. In most cases, the vertical middle plane divides the interface tool into right and left. The interface tool is more flexible about the mostly vertical middle plane than any of the mostly horizontal planes that extend through the interface tool.

Alternatively, the twisted perimeter edge of the sealing portion extends beyond the perimeter edge of the support member 5 over the entire length of the perimeter edge of the support member.

In yet another aspect, the sealing flange extends radially inwardly substantially from the entire circumference of the sealing member.

In yet another aspect, the sealing member further comprises a covering portion which is connected to the sealing portion adjacent to the twisted circumference of the sealing member, the cover portion being fixed to the support member.

In yet another aspect, the sealing portion of the sealing member is substantially more flexible than the sealing portion of the sealing member.

Alternatively, the twisted perimeter edge of the sealing member is defined by a plurality of radii Ri in the plan view, and the twisted perimeter edge has a thickness t and an inner radius R in the cut.₂, usually the horizontal plane passes through the first top linkage of the head unit and the second top linkage of the head unit, and the top of the twisted circumference of the sealing member is defined from above by a generally horizontal plane, and the entire top of the circumference₂/ t) <7 and (2) {Ri / R₂) <10.

In yet another aspect, the point of first contact is disposed along at least a portion of the sealing flange so that the sealing flange is adapted to contact the face of the user prior to the edge of the twisted circumference.

In yet another aspect, the support member comprises a plurality of individually replaceable members disposed between the head unit attachment and the seal member so that the replaceable members may transfer forces from the head unit to the seal member.

According to the invention, the breathing interface means comprises an inflatable soft adaptive sealing member adapted to cover the wearer's nose and boom The sealing member comprises a sealing portion adapted to contact the wearer's face. The sealing part consists of a twisted perimeter edge and a sealing flange extending inward from the perimeter edge. The sealing flange consists of an expanded surface with one edge joined to the twisted perimeter edge. The support member is attached to the sealing member. The support member is stiffer than the sealing member. The interface defines the camera. The air inlet passes into the chamber and the flow guide is positioned inside the chamber close to the air inlet. The flow guide forces at least a portion of the airflow from the airflow inlet to radially extend inside the interface means.

Alternatively, the diffused air stream is directed radially through at least a portion of the sealing flange.

In yet another aspect, the air flow inlet enters the interface means at an angle of about 0 ° to about 70 ° from the vertical.

In yet another aspect, the flow guide comprises a baffle.

In yet another aspect, the flow guide comprises a vortex-inducing structure.

In another aspect, the interface means is in combination with a head unit connected to the support means 10 of the interface means.

In the present invention, head equipment is used to attach a respiratory interface device to the head. The head unit consists of the first part of the strap. The first part of the strap has a lower back area. The lower posterior region is adapted to be located on or below the occipital protuberance. The lower posterior region is directed upward and toward the first lateral region and the second lateral region. The first lateral region extends laterally from the lower posterior region. The second lateral region extends laterally from the lower posterior region. Both the first and second lateral areas are adapted to extend beyond the incisor and over the ear. The first lateral region has a first arch portion, and the second lateral region has a second arch portion. The first arch portion and the second arch portion are joined by a top strap. The upper strap is adapted to extend over the head above the ears. The first boundary extends forward from the first arch portion and the second boundary extends forward from the second arch portion.

Alternatively, the upper strap is adapted to be disposed toward the top of the head and the lower posterior region is adapted to be positioned below the top of the head so that the top of the head is secured between the upper strap and the lower posterior region.

In yet another aspect, at least a portion of the first strap is semi-rigid.

In yet another aspect, the top strap has a first portion and a second portion, the first portion and the second portion being connected to one another.

In yet another aspect, the head unit comprises a first inelastic connecting strap and a second inelastic connecting strap, the first inelastic connecting strap and the second inelastic connecting strap being attached to the interface means.

In yet another aspect, the head unit comprises a first elastic connecting strap and a second elastic connecting strap, the first elastic connecting strap and the second elastic connecting strap being attached to the interface means.

In yet another aspect, the first inelastic connecting strap and the first elastic connecting strap extend parallel between the first limiting member and the interface means, and the second inelastic connecting strap and the second elastic connecting strap extend parallel between the second limiting member and the interface means.

In yet another aspect, the head unit comprises a third inelastic connecting strap and a fourth inelastic connecting strap, the third inelastic connecting strap and the fourth inelastic connecting strap extending between the first portion of the strap and the interface means.

In yet another aspect, the head unit comprises a first lower link strap and a second lower link strap extending away from the first portion of the strap, at least a portion of the first and second lower link straps being semi-rigid, wherein the first and second lower link straps , with the lower posterior region positioned on the head in a less likely manner, so that the first lower link strap and the second lower link strap become tangled behind the head when the head equipment is placed on the head.

In yet another aspect, the first lower link strap and the second lower link strap are connected to the lower posterior region, and the semi-rigid portion is a direct connection between the first lower link strap, the second lower link strap, and the lower posterior region.

In another aspect, the head assembly is in combination with the interface means, the interface means comprising a support member and a sealing member, the sealing member coupled to the support member, the head equipment coupled to the support member.

Alternatively, the adjusting line has an upper sliding joint between the adjusting line and the upper portion of the interface means. The bottom slider is located between the adjustment line and the bottom of the interface tool. The left slider is located between the adjustment line and the left side of the head unit. The right slider is located between the adjustment line and the right side of the head unit. The adjusting line connects the upper sliding link, the left sliding link, the right sliding link, and the lower sliding link.

In yet another aspect, the adjusting mechanism is attached to the adjusting line so that the length of the adjusting line can be varied, thereby changing the tension in the head unit and interface assembly.

In yet another aspect, the adjusting mechanism changes the length of the adjusting line to provide a predetermined level of voltage between the interface device and the head unit.

Alternatively, the interface means is coupled to the head unit with a tension member, the tension member interacting with the locking member such that the tension member forms an elastic connection between the interface tool and the head unit during assembly of the head unit and the lock member forms an inelastic connection between the interface tool and head. equipment, with the interface device and head unit installed.

In yet another aspect, the tensioning member comprises an adjustable length line and the locking member comprises a buckle.

In yet another aspect, the interface means support element includes accessories for the head unit.

Alternatively, the head unit is connected to the interface means at the first connection point 10, the head unit configured to adjust the tension of the head unit at or forward of the first connection point.

Alternatively, the attachment of the head unit to the interface means does not have a strap that creates tensile bending back toward the head unit from the first point of attachment.

Alternatively, the first attachment point has a projection and the head unit has at least one corresponding aperture 15 engageable with the projection.

In accordance with the present invention, the interface means and the method of attaching the head unit to the head with the head unit movably and elastically coupled to the upper part of the interface means include applying the interface tool to the face with the first hand, grasping the posterior portion of the head unit, and stretching the back of the head unit on the head until the top strap of the head unit rests on the top of the head, releasing the head unit with the second hand, and releasing the interface means with the first hand such that the elastically coupled head unit with the interface means substantially remains in that position without being retained by either the first or second hand, attaching the inelastic lower strap to the interface device; interface means such that the interface device and head unit are rigidly connected.

In another aspect, the elastic member extends between the head unit and the interface device to form an elastic connection between the head unit and the interface device, the method further comprising orienting the interface member with the elastic member between the top of the interface device and the head unit. correctly oriented with respect to the face.

Alternatively, the interface means has a seal with an inwardly extending flange, the flange having a recess adapted to accommodate the chin, this method further comprising locating the chin in the recess while placing the interface means on the face with the first hand.

In yet another aspect, the position of the chin in the niche is determined before the interface device contacts the nose.

Brief description of the drawings

These and other features, aspects, and advantages of the present invention will now be described with reference to the drawings of several preferred embodiments, wherein the embodiments are intended to illustrate, not limit, the invention, and wherein the figures:

FIG. 1 is a block diagram of a wet positive airway system that may be used in conjunction with a patient interface device and / or head unit that are arranged and shaped in accordance with certain features, aspects, and advantages of the present invention.

FIG. 2 is a side elevational view of an interface device arranged and formed according to certain features, aspects and advantages of the present invention. The illustrated device is shown mounted on a user but without a head unit or connected breathing tube.

FIG. 3 is an interface means shown in FIG. 2, perspective view.

FIG. 4 is a sealing member of the interface means shown in FIG. 2, external front perspective view.

FIG. 5 is a sealing member of the interface means shown in FIG. 2, internal posterior perspective view.

FIG. 6 is a schematic cross-sectional view of a portion of the sealing member showing the twisting and inflating aspect of the sealing member.

FIG. 7 is a graphical representation of the winding properties of the sealing member.

FIG. 8 is a schematic sectional view of a portion of the sealing member showing an additional twisting and inflating aspect of the sealing member.

FIG. 9 is a graphical representation of the preloading properties of the sealing member. FIG. 10 is an interface member support member of FIG. 2, external front perspective view.

FIG. 11 is an interface member support member of FIG. 2, outer posterior perspective view.

FIG. 12 is a graphical representation of the flexibility of the support member and of the flexibility of the sealing member.

FIG. 13 is a front perspective view of another interface means, which typically includes the interface means shown in FIG. 2, a user-mounted modification using head equipment which are arranged and formed in accordance with certain features, aspects and advantages of the present invention. An illustrated interface device is shown with a breathing tube or a connected delivery duct.

FIG. 14 is a front perspective view of an interface device arranged and formed in accordance with certain features, aspects and advantages of the present invention with a breathing gas inlet located at the bottom of the interface device. The gas inlet is located close to the user's chin.

FIG. 15 is a top view of an interface means arranged and formed in accordance with certain features, aspects, and advantages of the present invention, the interface device shown in one or more bending modes.

FIG. 16 is a front perspective view of another interface device arranged and formed in accordance with certain features, aspects and advantages of the present invention. The interface is illustrated with headband straps, shown on one side only.

FIG. 17 is a front perspective view of another interface device arranged and formed in accordance with certain features, aspects and advantages of the present invention. The interface tool is shown without the head unit straps.

FIG. 18 is a front view of an interface means similar to the one shown in FIG. 16 and 17, with a support member 15 arranged and formed in accordance with certain features, aspects and advantages of the present invention.

FIG. 19 is a front view of an interface means similar to the one shown in FIG. 16 and 17, with a support member disposed and formed in accordance with certain features, aspects and advantages of the present invention.

FIG. 20 is a front view of an interface means similar to the one shown in FIG. 16 and 17, with a support member disposed and formed in accordance with certain features, aspects and advantages of the present invention.

FIG. 21 is a front perspective view of an interface means with a support member arranged and formed in accordance with certain features, aspects and advantages of the present invention.

FIG. 22 is a front perspective view of an interface means comprising the interface means of FIG. 2 mounted on a user using head equipment which is arranged and shaped in accordance with certain features, aspects and advantages of the present invention. An illustrated interface device is shown with a breathing tube or a connected delivery duct.

FIG. 23 is a side elevational view of the interface device and head unit, the device being arranged and formed in accordance with certain features, aspects, and advantages of the present invention, with a breathing tube or delivery conduit elbowed to the interface device.

FIG. 24 is a rear view of an interface device arranged and formed in accordance with certain features, aspects and advantages of the present invention. The illustrated interface means has a pressure cavity with a diffuser opening.

FIG. 25 is a rear perspective view of an interface device which is arranged and formed in accordance with certain features, aspects and advantages of the present invention. The illustrated interface device has a vortex-flowing shape.

FIG. 26 is a side elevational view of an interface device and head unit that are arranged and shaped in accordance with certain features, aspects, and advantages of the present invention.

FIG. 27 is a front perspective view of another interface means, typically 10 comprising the interface means shown in FIG. 2, a user-mounted modification using head equipment which is arranged and shaped in accordance with certain features, aspects and advantages of the present invention. An illustrated interface device is shown with a breathing tube or a connected delivery duct.

FIG. 28 is a side view of aspects and aspects of the head unit and head unit which are arranged and formed in accordance with certain features of the present invention. Illustrated head equipment has integrated elastic and inelastic straps.

FIG. 29 is a side elevational view of a device and head unit that are arranged and shaped in accordance with certain features, aspects and advantages of the present invention. Illustrated head equipment has integrated elastic and inelastic straps and ridge.

FIG. 30 is a perspective view of a head unit arranged and formed in accordance with certain features, aspects, and advantages of the present invention.

FIG. 31 is an interface means and head unit shown in FIG. 30 and attached to the user, a perspective view.

FIG. 32 (a) to 32 (d) - Shows a sequence of steps 25 for mounting the interface device and head unit, the interface means and head unit being arranged and formed in accordance with certain features, aspects, and advantages of the present invention.

FIG. 33 (a) -33 (d) illustrate a sequence of mounting steps for an interface device and head unit, the interface means and head unit being arranged and formed in accordance with certain features, aspects, and advantages of the present invention.

FIG. 34 is a view showing the connection strap and the first portion of the strap illustrated in FIG. 30, a joint with a first portion of the strap extending at least above the portion of the connecting strap to form a tension compensator and reinforcement.

FIG. 35 is a graphical representation of the relationship between the interface tool and head unit skin pressure and leak rate from the interface tool.

FIG. 36 is a schematic representation of the test relationship between pressure and leakage rate.

In a preferred embodiment, a detailed description

Common system

FIG. 1 shows a humidified positive airway 100 system (PAP) in which Patient P or another user receives humidified and compressed gas through the Patient Interface Device 102. PAP system 100 may be continuous, variable, or dual level positive airway or any other suitable a form of respiratory therapy. In some configurations, PAP System 100 could be a hospital fan or have a ventilator or any other appropriate form of respiratory therapy. In some applications, interface means 102 may be used with non-wetted PAP systems.

The interface means 102 is connected to a conduit defining a wet gas transport path or, for example, an inhalation tube 104. The conduit 104 may include heating means or a heater wire (not shown) that heats the gas or conduit walls to reduce condensation of the wet gas.

The channel 104 is connected to the outlet of the irrigation chamber 108. Preferably, the irrigation chamber 108 has a water reservoir 110. Preferably, the irrigation chamber 108 is formed from plastic materials. In some configurations, the humidifier chamber has a high conductivity substrate (e.g., an aluminum substrate or the like) that contacts the humidifier 114 heater board 112 directly.

The humidifier 114 has a regulator 116. The regulator 116 may be any suitable regulator or regulator, and may be an electronic regulator. The controller 116 may consist of a controller based on a microprocessor that executes computer software commands stored in associated memory.

Controller 116 accepts input from sources such as, but not limited to, user input 118 (e.g., dialing, buttons, and the like) through which a user of system 100 may determine, for example, without limitation, a value (e.g., a predefined value, entered value, or the like) that reflects the desired level of humidity and / or temperature of the gas supplied to the patient. The controller may also receive input from other sources (e.g., switching temperature and / or flow rate sensors 120, 122, and heater board temperature sensor 126).

Based on a user-defined humidity and / or temperature value that can be entered by user input 118 and other inputs, controller 116 determines when or at what level to power the heater board 112 to heat the water reservoir 110 in the irrigation chamber

108. When the water tank 110 in the irrigation chamber 108 is heated, water vapor begins to accumulate in the irrigation chamber 108 above the surface of the water tank 110.

Water vapor exits through vent 106 of irrigation chamber 108 with a flow of gas (e.g., air) from gas supply blower 128 or other suitable gas delivery means, gas flow into irrigation chamber 108 through inlet 130. Exhaled gas from a patient's mouth transmitted directly to the environment as shown in FIG. 1, or when ventilator assisted, exhaled gas is returned to the ventilator via an exhalation tube (not shown).

Blower 128 has a variable pressure regulator, variable pressure control means 10, or variable speed fan 132 that draws air or other gas through the blower inlet 134. The speed of the variable speed fan 132 is controlled by the regulator 136 according to the inputs 136 and the user input 138 (e.g. ., dial, button, or the like) a user-defined preset or preset pressure value or fan speed. In some configurations, the functions of the controller 136 could be performed by the controller 116.

The patient interface means 102 typically comprises a mask and associated head equipment. The following patient interface tools are particularly useful in hospital or other emergency settings where the patient often requires immediate respiratory treatment. In addition, in such situations, the patient is often treated with long-term or often continuous periods of artificial respiration therapy. Thus, interface devices should be quickly applied to patients, and interface devices should provide greater convenience. Preferably, the interface devices and head unit assembly can be initialized in less than 25 seconds, achieving a leakage rate of less than about 20 rpm. , at a supply pressure through the interface of approximately 15 cmH₂0. In addition, as shown in FIG. 35, it is desirable that the interface device and head unit assembly achieve a leakage rate of less than about 15 rpm and a skin surface pressure of less than about 22.5 mmHg at a delivery pressure of about 15 cmH through the interface device.₂0. The pressure on the skin surface of 22.5 mmHg was found to be clinically significant, reducing the likelihood of developing pressure ulcer over longer treatment periods. It was found that

15th The 1 / min leak rate is related to the stability of the equipment used to produce the compressed gas. In some configurations, the pressure on the skin surface may be less than about 18 mmHg at a leak rate of less than about 11 1 / min.

With reference to FIG. 36 will describe a method for determining skin surface pressure and runoff rate. As shown in FIG. 36, one or more sensors 150 may be disposed on the face of test subject P. The sensor or sensors 150 may be disposed along the contact areas of interface means 102. Preferably, the transducer or transducers 150 are disposed along areas that are prone to pressure ulcers during treatment (e.g., the area extending from the cheekbones, under the eyes, and across the nasal cavity). Sensors 150 are adapted to measure pressure. In some configurations, the sensors 150 are pressure transducers. Preferably, the sensors 150 are pressure transducers having an operating range of about 0 mmHg to about 100 mmHg. More preferably, the transducers 150 are pressure transducers with an operating range of about 0 mmHg to about 50 mmHg. It is also desirable for the sensors 150 to be thin-film pressure transducers. In some configurations, the transducer 150 has a thickness of about 0.5 mm or less.

When the sensors 150 are located on the subject's face, the interface means 102 may be applied to the subject's face so that the interface means rests on the sensors 150. A pressure source 128 may be applied to supply compressed gas through the interface means 102 to the subject. Preferably, the gas is pressurized to about 15 cmH for analysis₂0. The interface means 102 may be secured by tensioning the head unit 700. Preferably, the head unit 700 is used to provide sufficient tension to reduce the passage between the interface means and the subject's eye area to approximately zero. For test purposes, the system shall not use diagonal flow openings (ie, any diagonal flow openings in the system shall be blocked) so that any leakage occurs only between the interface device and the test subject.

With the interface medium tucked on the subject's face and the pressure source supplying a pressure gas of about 15 cmH20, the subject holds his breath so that the pressurized gas is drained from the seal between interface means 102 and the subject's P face. The leakage rate may be determined by the flow meter 152. The flow meter 152 may be integrated with a fan or other positive pressure source, the gas or flow meter 152 may be a separate component. Preferably, the flow meter 152 operates in the range of about 0 rpm to about 200 rpm.

While the compressed gas is flowing, the rate of leakage and pressure between the interface device and the subject's face can be monitored. When the maximum leakage rate and maximum pressure are recorded, the head unit 700 can be adjusted to provide tension (eg, increase) and additional data may be obtained. Multiple data points may result in a performance frame for the interface tool, which reflects skin pressure and leakage rates. Multiple subjects may be used to provide multiple readings.

Unprotected nose mask

According to FIG. 2, the interface means 102 is comprised of an interface means housing 200, which generally has a sealing member 202 and a support member 204 which are well accommodated. Interface 2 102 is shown on Patient P without any attached head unit or respiratory tube connections. As will be described, at least the exterior portion of interface means 102 corresponds substantially to a replica of at least one human face. In some configurations, at least the outer portion of interface means 102 substantially forms at least a copy of the human nose.

As shown in FIG. 2, the interface means 102 is a continuous face mask 10 which includes both the nose N and the boom of patient P or another user. The size of the interface means 102 may be set depending on the application. In other words, interface means 102 may be of various sizes to accommodate use by patients or other users, which may vary in age from the age of two years. The size of the interface 102 is based on a measurement from the chin to the patient's nose. Preferably, the size should cover all successive sizes of the interface tool, overlapping between about 3mm and 7mm. Even better, the sizes overlap about 5 mm. For example, three sizes of interface tools can be represented by chin-to-nose tip criteria: small or size 1 for those up to about 110mm; medium or size 2 for those between about 105mm and about 130mm; and large or size 3 for those measuring from about 125mm to about 145mm. It is good to have measuring ranges overlapping from one size to another, for example, where two sizes can be used on one patient due to overlap, which ensures that patients do not fall within the size range. Other measurement methods may also be used.

Ideally, the shape of the outer surface of the interface means 102 is similar to that of a hand, which improves the action of the person placing the interface means 102 on the patient. Preferably, the illustrated interface means 102 will promote the adhesion of the interface means 102 by applying the interface means 102 to the chin area. This local stickiness allows the health care professional to not approach the patient's eye area when the interface device 102 is applied, which may cause the patient to be more comfortable when the device is applied. In addition, the copy of the nasal protrusion clearly shows the correct position on the patient's face and is significant both visually and by touching the right spot in a very simple and intuitive way of applying and using the mask.

Preferably, interface means 102 is low profile to substantially conform to the facial contour. This reduces the patient's concerns about the mask and reduces the compressible internal volume, making interface device 102 particularly useful for ventilation. Preferably, the low profile interface means 102 extends beyond the patient's line of sight and has only minimal effect on the patient's peripheral vision. In addition, the prior art low profile interface means 102 reduces the compressible volume defined within the interface means, while also reducing the volume of re-inhaled CO2, each factor providing a more desirable interface design and enhanced interface performance.

Adaptive sealing element

According to FIG. 2, 4, and 5, the adaptive sealing member 202 is an interface member 200 that contacts a P face of a patient. The sealing member 202 is of the inflatable or stretchable type. An inflatable or stretchable type of seal is a type of seal whereby system pressure or airflow is applied to the interface means 102 by pushing an inwardly extending flange, periphery, or the like onto the patient's face to form a firm seal. Thus, the inflatable or stretchable seal differs from other sealing types in that it relies solely on the retaining forces of the interface means obtained from the head unit to push or deform the cushion toward the patient's face with sufficient force to press the cushion tightly against the patient's contours.

In order to provide a proper inflating or stretching effect, the sealing member 202 shown comprises a circumference edge 206 and a sealing flange 208 extending inwardly of the circumference edge 206. Preferably, the sealing flange 208 extends inwardly of all or substantially the entire circumference edge 206. As will be described, it is desirable that the circumference edge 206 form a twisted edge.

According to FIG. 5, the sealing flange 208 illustrated comprises a continuous surface 210, at least a portion of which is in contact with the face surface of patient P. An expanded surface 210 having a single end portion connected to the perimeter edge 206 defines a pocket-like structure that accumulates supply air or pressure and pushes the flange 208 of the interface means housing 200 toward patient P to the desired degree. The sealing flange 208 may define the sealing portion 212 of the illustrated sealing member 202. When used, the sealing portions 212 are facing the patient or are closest to the patient. According to FIG. 6, the sealing portion 212 of the illustrated sealing member 202 may be connected to the cover portion 214 of the sealing member 202 by an edge 206 which may be defined by a twisted edge or an edge of a beam.

Preferably, the sealing portion 212 is substantially more flexible than the covering portion 214. The sealing portion 212 may be formed, for example, but not limited to, of the same material as the covering portion 214, but may have a thickness less than the thickness of the covering portion 214. In some embodiments, the sealing portion 212 may use other material, such as silicone, thermoplastic elastomer, or foam (e.g., open or closed, including film) relative to the coating portion 214. Using the sealing portions 212 is supported against the patient P face and, with the inflatable sealing internal pressure and head unit support pressure, the sealing portion 212 is pressed against the patient P face to provide an effective inward sealing of the perimeter edge 206.

Referring to FIG. 4, the perimeter edge 206 forms a shape that can be defined by a series of 10 beams Ri. The radius Ri may define the outer surface of the twisted perimeter edge 206. Thus, the outermost portion of the twisted perimeter edge 206 has a planar image defined by a series of rays Ri. In addition, as shown in FIG. 6, the twisted perimeter edge 206 may be defined by thickness (t) and inner radius (R2). FIG. 7th illustrates the desired relationship between the ratio of the inner radius of the twisted portion 206 of a circumferential portion to the thickness of the wall of the perimeter edge in a given segment (Ri / t); inside radius at a given segment of the perimeter edge (R1 / R2), further twisted to the ratio. As shown in the drawing, it has been found that at a wall ratio of about 4 or less, the peripheral edge 206 of the sealing member 202 may be compressed in that particular segment more than is indicated by the desired twisting. In addition, a wall ratio of about 7 or more has been found to lead to a configuration that may be too rigid in that particular segment to allow the desired twisting. Further, it has been found that at a radius ratio of about 10 or more, a particular segment of the sealing member 202 may be too straight to be desired to be twisted. Thus, FIG. The dashed area in Figure 7 is a twisting region of the desired perimeter edge 206. The perimeter edge 206, since a series of beams is defined in the plan view, may have various segments disposed in the desired twisting region. It is desirable that at least the upper portion 206 of the perimeter edge (i.e., the portion that, when used, will carry the effluent usually in the direction of the eyes) is shaped such that the dimensions are completely within the desired twisting region. In other words, it is desirable that those segments satisfy the following two equations: (1) 4 <(R2 / O <7 and (2) (R1 / R2) <10. In some configurations, at least the nose portion of the sealing member 202 and the extending side portions of the sealing member extending toward the cheekbones are shaped such that the dimensions (i.e., twisting radius, plane radius, wall thickness) determine at least those segments the previously identified equation. In some configurations, at least the portion of the sealing member 202 above the generally horizontal plane that intersects the top attachment site of the head unit is shaped such that its dimensions (i.e., twisting radius, plane radius, wall thickness) determine at least those segments domain and corresponds to previously identified equations. In some configurations, the entire circumference of the sealing member 202 is shaped such that its dimensions (i.e., twisting radius, plane radius, wall thickness) determine the passage of each segment into the desired twisting area and corresponds to the previously identified equations.

Preferably, the sealing portion 212 is curved inwardly so that the sealing portion 10 212 forms an acute angle relative to the covering portion 214. Further, with respect to FIG. Flange 8 208 is shown in contact with patient's P skin surface. As shown relative to the first contact point 216, which is the end of the radius R of the flange 208 disposed furthest from the perimeter edge 206 in the embodiment shown.₂ the start may be arranged at a distance 218 from about 0 mm to about 40 mm or more. As shown in FIG. In Figure 9, it is assumed that there is a relationship between (1) distance 218 (i.e., the distance between the first contact point 216 and the radius R₂ and) (2) the preload angle Θ, which is the angle between the flange 208 and the skin surface, regardless of the arrangement around the perimeter edge 206. The preload angle may be as shown graphically in FIG. 9, where the graph was created empirically. In this connection, the flange 208 can roll smoothly and fit snugly against Patient P's face. As shown in FIG. 9, increasing the contact length on the skin of the patient P can reduce the contact angle, indicating that the degree of protrusion of the free end of the flange can be reduced by a significant contact length. On the other hand, the larger projection of the free end of the flange can ensure proper sealing over a shorter contact length. In some configurations, the selection of length 218 may be based on a change in the patient's facial contour. In other words, just as an example, to obtain a single mask size for a diverse population, the flange is longer in the chin area, where facial dimensions are most variable, and the flange is shorter in the nasal region, where facial contours are less variable in a particular ethnic group. The dimensions of the nose hill can vary between different ethnic groups. At the desired desired lengths, the angle can be adjusted to reduce the likelihood of leakage.

As described simply above, the first contact point 216 is obtained because the end of the flange 208 protrudes outwardly at least in some locations. In some embodiments, the free end of the flange 208 is the first surface 200 of the interface means body in contact with the patient's P face. Preferably, the length 218 of the flange 208 extends toward the patient's face from about 0 mm to about 10 mm. In some embodiments, the projection is from about 3 mm to about 7 mm.

It is good that when the flange 208 is directed toward the patient's face, the free end of the flange 208 or other portion of the flange 208, when touched, tilts the patient's face inward (i.e., folds in) from the normal position, gradually increasing the mask contact with the patient's face. Thus, the applied flange is preloaded, providing tightness with increased ability to match various facial anatomy and contours, which in turn allows for improved sealing characteristics of interface means 200.

Since the illustrated sealing member 202 is an inflatable or stretchable seal 10, the sealing member 202 aims to reduce pressure on the skin. Further, the sealing member 202 distributes pressure and reduces the likelihood of a large localized pressure distribution. In other words, the illustrated sealing member 202 reduces the likelihood of a point load or excessive pressure gradient.

Again with reference to FIG. 2, sealing member 202 is shown enveloping the nose N and boom of patient P 15. Sealing member 202 as shown in FIG. 4 and 5, form part of nose 220, the shape of which is essentially a copy of the human nose. Preferably, the nose portion 220 is the upper portion of the sealing member 202. In the illustrated configurations, the outer surface of at least a portion of the nose 220 is formed substantially as a replica of a human nose. Preferably, the outer surface and the inner surface of the nasal portion 220 are formed substantially as a copy of a human nose. In particular, in the illustrated configurations, the nose portion 220 reproduces the nasal-shaped core portion. Thus, the nasal portion 220 reproduces most of the nasal forms.

In some embodiments, the nose portion 220 of the sealing member 202 reproduces the entire nose or nearly the entire nose. In the illustrated embodiments, the nasal shape will be a generalized nasal shape rather than corresponding to a particular patient. The illustrated nose portion 220 has a nasal tip 222. The illustrated nose portion may also have downwardly extending nostrils 224 or the like. Preferably, the nose portion 220 mimics sufficient features typical of a human nose and is similar to a human nose. However, in some embodiments, the sealing portion 202 may include a portion formed as a pocket or nasal chamber 226 that can accommodate a human nose, but does not provide a substantial copy of the appearance of the nose. In other words, the sealing member 202 may include, but is not limited to, a nose portion having an approximately rectangular cuboid shape or substantially a shape such as a semi-cylindrical shape.

Preferably, the nasal chamber 226 of the nasal portion 220 is larger than a typical nose to accommodate the nose of various users within the nasal portion 220. Preferably, the sealing portion 202 has a septum projection 228. The septum projection 228 extends forward of the septum region (i.e., face to face when worn) to define an enlarged recess inside the sealing member 202 in the patient's nasal septum region. It is also desirable for the sealing member 202 to have an upper lip projection 230 disposed close to the center of the upper lip. By providing one or more septum projections 228 and an upper lip projection 230, the nasal chamber 226 is enlarged at such locations to provide additional clearance in the sealing member 202.

Referring to FIG. 5, the sealing portion 212 of the illustrated sealing member 202 may be formed substantially conforming to a typical face shape. In the illustrated configurations, the sealing portion 212, which includes the flange 208, has a hollow region 232. The hollow region 232 may accommodate the patient's chin. The hollow region 232 may hold the chin along portion 208 of the flange. Further with respect to FIG. 5, illustrates a sealing portion 212 which includes a flange 208 and also includes a gutter 234 for a nose roll. Gutter 234 may have a curved wall, which is generally C or U shaped.

Further with respect to FIG. 5, illustrated sealing portion 212, which includes flange 208, has curved cheek portions 236 extending between the hollow region 232 located at the patient's chin and the gutter 234 at the patient's nose mount. The curved cheek portions 236 may connect to the nearest hollow region 232. Additionally, the duct 234 is disposed between the curved cheek portions 236 and in some cases separates or connects them.

FIG. 4 shows an exterior view of the sealing member 202. The exterior view better illustrates the covering portion 214. In the illustrated configurations, the sealing member 202 includes the cheek portions 238, the chin portion 240, and the nose portion 220. Preferably, the cheek portions 238 extend sideways from the nasal portion 220. In use, the cheek portions 238 extend laterally from the nose. area toward the patient's cheekbone. The cheek portions 238 also extend downward with the lateral portions 239 toward the chin portion 240. Thus, the cheek portions 238 extend toward the patient's jaw with the outermost lateral sides of the face.

Again with reference to FIG. 4 and 5, the sealing member 202 defines an opening 242 extending from the outer surface to the inner surface of the sealing member. The orifice 242 may be positioned with respect to the position of the patient's mouth during or below the use of the interface means 200. In some embodiments, the opening 242 is disposed below the nasal chamber 226. The opening 242 may be described as being located below the septum projection 228. Further, the opening 242 may be described as located below the upper lip projection 230. In addition, the opening 242 may be described as being located above the hollow region 232 which accommodates the patient's chin. Thus, opening 242 may be located between the locations where the patient's boom and chin tip can be expected. Preferably, the opening 242 is disposed along the center plane of the sealing member 202, where the center plane typically divides the sealing member 202 into a right-hand side and a left-hand side. For reasons that will be explained below, the illustrated opening 242 is located in a generally planar portion 244 of the sealing member.

Support element

Again with reference to FIG. 2, the support member 204 lies on a portion 202 of the sealing member. The support member 204 is significantly more rigid than the seal member 202, because the support member 204 provides support for the seal member 202. However, the support member 204 may still be somewhat flexible, and preferably the support member 204 will not be completely rigid. In some configurations, the support member 204 has a similar resistance to, for example, but not limited to, polypropylene or polyethylene plastic about 1 mm thick.

As shown, the support member 204 has a circumference edge 250. The circumference edge

250 may have a shape similar to the perimeter edge 206 of the sealing member 202, but when the notch 252 is included and the engaging distance is retracted to the perimeter edge 206, it is desirable that the length of the perimeter edge 250 be shorter than the length of the perimeter edge 206. In other words, it is desirable that the circumference of the support member 204 be shorter than the overall length of the sealing member 202. Because of the inclusion of the upper portion of the nose 220 in the circumference of the sealing member 202, the overall length of the support member (even including the cutout 252) is less than the total length of the peripheral edge 206 of the support member 204.

In some configurations, the sealing member 202 extends outwardly beyond the support member 204 at all locations. 6, radius R₂ may be set at an RO distance of about 3 mm to about 6 mm, from the peripheral edge 250 of the support member 204 to the outer surface twisted over a portion of the sealing member 202.

As shown in FIG. 10 and 11, the illustrated support member 204 comprises a contoured plate-shaped exterior. In other words, the shape of the support member 204 is three warp without high relief. Preferably, the overall relief depth of the support member 204 is less than about 50 mm to about 65 mm in interface devices for middle-aged adults.

In other respects, the generally smooth and continuous perimeter edge 250 is terminated by a top notch 252. The notch 252 is disposed in the area of ​​the patient's nose. Thus, FIG. In the illustrated embodiment 2, the support member 204 does not have a portion resembling a human nose. Without a portion of the human nose, the support member 204 has improved housing flexibility. Instead, the shape of the human nose is defined by a sealing member 202 or some other element of the interface means 200. Notch 252 improves the flexibility of the support member 204. Thus, at different angles of the cheekbones, the support member 204 will be more flexible to the patient.

In the illustrated configurations, the nose portion 220 of the sealing member 202 protrudes from the upper recess 252 in the support member 204. The shape of the depicted recess 252 accommodates the nose portion 220 of the sealing member 202 in the support member. front to rear (i.e., the formed support member 204 is low profile and has a small relief depth).

The overall impression illustrated configuration provides a full face interface device similar to a human face shape and assists in controlling inflow of the sealing member by maintaining the sealing member 202 overlay portion 214. The external appearance of the interface means partially resembles human appearance during use to patients and caregivers. emotional response. Importantly, this can improve patient compliance with the interface tool and thus improve the order of use.

Preferably, the notch 252 defines a recess extending inward from the peripheral edge 250 of the support member 204. In the illustrated configurations, the notch 252 extends inward toward the center of the interface member 200 or at least the support member 204. The recess 252 may have an extended recess portion 251 for accommodating the septum. It is expected that other suitable profiles may also be applied to the notches 252. In some configurations, the notch 252 may be disposed over the ridge 253, which defines a gutter inside the support member 204 to subsequently accommodate the center portion of the upper lip.

In the depicted support member 204, a notch 252 is surrounded by a pair of upwardly extending extensions 254, which is divided by a notch 252. Preferably, the upwardly extending 254 defines an upper extension of the support member 204 More preferably, the upwardly extending 254 defines the upper portion 200 of the interface except for the highly flexible parts of the sealing member 202.

Referring to FIG. 2, Patient P's nose N is shown in dotted lines. The nose N is inserted into the chamber 226 defined by the nose portion 220 of the sealing member 202, while the notch 252 of the support member 204 intersects the median plane below the nose N. The upwardly extending extensions 254 of the support member 204 extend upwardly from the base B of the nose.

In the illustrated configuration, the upward extensions 254 extend upstream of the portion of the interface device 200 that is designed to accommodate the N tip of a patient's P's nose.

The lateral edges of the notch 252 extend adjacent the lateral N edges of the nose such that the adaptive sealing member 202 may extend along the cheekbones and so that the support member 204 may reinforce the sealing member 202 in the cheekbone region. Retracting the interface device housing 200 to patient P's cheekbones can significantly improve patient P's level of comfort.

The upward extensions 254 also provide a stabilization function and at least partially define the stabilizer means of the illustrated mask on the central portion of the patient's face. In particular, the upward extensions 254 approximately correspond to or partially cover the location of the cranial jaw.

The support member 204 typically corresponds to a typical lower portion of the human face. As such and in view of FIG. 10 and 11, the outer surface 256 of the support member 204 has a conventional convex image, and the inner surface 258 of the support member 204 has a normal convex image.

The inner surface 258 of the support member 204 generally corresponds to the outer surface of the sealing member 202. The chin portion 260 of the abutment member 204 may have a hollow concave along the inner surface 258 of the abutment member 204. Additionally, each pair of cheek portions 262 is formed by a hollow concave along the inner surface of the abutment member.

The peripheral edge 250 of the support member 204 generally extends from the outside of the cheek portions 262 to the outside of the chin portion 260 and generally extends to the inside of the patient's jaw line. For example, the perimeter edge depicted by the support member extends to the patient's P chin. Preferably, the lower portion 264 of the support member 204 engages under the patient's P chin. By engaging under patient P's chin, support member 204 assists seal member 202 in sealing patient P's face in this area. The illustrated support member 204 defines the boundaries of the material that support the seal member 202 and reinforce the chamber defined by the cover member 214 of the seal member 202. In some configurations, the support member 204 defines a reinforcing edge that typically surrounds the member of the seal member 202.

As shown in FIG. 2 and 3, the interface means housing 200 generally reproduces the overall shape of the lower part of the user's face. The interface device housing 200 may cover the nose at the top. In some configurations, the interface device housing 200 is adapted to overlap at least a portion of the nasal bone, which is a bone extending above the nasal cartilage and disposed between the eyes. At least the sealing member 202 may have wings extending outwardly toward the cheekbones such that the sealing member 202 extends outwardly along the cheekbones. The body 200 of the interface device extends downwardly along the jaw line, where the lower portion 264 of the support member 204 engages under the chin.

Continuing the reference to FIG. 10 and 11, the support member 204 also typically has a central opening 266. The aperture 266 is generally disposed beneath a notch 252. Preferably, the aperture 266 is disposed along a central plane of the interface means housing 200 that is flat and divides the interface means 200 illustrated. essentially symmetrical two sides, left and right. In the depicted configuration, the aperture 266 and the notch 252 are disposed along the center plane. The median plane intersects, and is preferably half, with orifice 266 and notch 252.

Preferably, the opening 266 in the support member 204 corresponds to the location of the opening 242 defined by the sealing member 202. The opening 242 is illustrated more clearly in FIG. 4 and 5. The opening 242 provides space for a breathing gas inlet and outlet chamber defined on the front side of the sealing member 202. An orifice 242 disposed in the plane portion 244 facilitates convenient connection and sealing of the breathing tube to the sealing member 202. The support member 204 may also be configured in the region 266 of the aperture to support the breathing tube connector (e.g., an elbow connector or other configuration connector).

Part of the nose hill

Referring to FIG. 13, some embodiments of the support member 204 may also include a mount portion 300 extending at least through the seal member 202 in the region of the cutout 252. Thus, in some embodiments, the mount portion 300 may be disposed at the perimeter edge 206 of the sealing member 202 in the region of the nose portion 220. The mount portion 300 may provide an additional support for the sealing member 202 that is suspended therein. Additional support may be helpful in reducing the likelihood of air leakage along the sides of the nose, where air leakage may stray close to the patient's eyes.

According to FIG. 14, the hump portion 300 in the sealing member 202 in this embodiment extends through the sealing member 202 near the perimeter edge 206. Preferably, the hump member 300 shown in FIG. 14, would be about 5mm to 6mm wide. FIG. The embodiment illustrated in FIG. 14 provides flexibility for the support member 204 and the seal member 202 which are more responsive to the wearer's facial contour. In other words, the support member 204 has a less flexible stiffness which allows the interface member 200 to flex according to the retaining force of the headband straps, while the mount portion 300 provides support for the sealing member 202 at or near the nose portion 220. The portion of the mount helps reduce the likelihood of deflection of the sealing member 202 in the portion of the nose, the deflection can cause air leakage to be directed near the eyes.

Continuing to refer to FIG. 14, the load 302 applied in the transverse direction, while holding the opposite side of the mask motionless, causes a bend about the middle plane of the interface means 200. In the illustrated embodiment, the flexibility reduces the overall width of the interface tool 200. The force 302 is applied to the cheek portion of the interface device 200

262. Preferably, the force 302 at a magnitude of about 1 N is displaced, at least about 4 mm and greater, preferably at least about 5 mm, when measured generally parallel to the direction of the force 302. Although headgear is not usually subjected to an arrow direction force 302, it has been found that the described flexibility can be applied to the interface means 200. It has also been found that flexibility can achieve better sealing of the sealing member 202 over a wide range of facial contours.

Preferably, the folding or bending takes place about the median plane. In some embodiments, it is desirable that the interface device 200 be more flexible or more deformable in the cheekbone region (i.e., the upper portion) of the interface device 200 relative to the jaw region (i.e., the lower portion) of the interface device 200. Such a difference in the flexibility zones can be achieved by a notch 252. Thus, notch 252 can be used to create an interface tool that is more deformable in the cheekbone, where more anatomical differences can be expected, and where the face is more susceptible to discomfort.

Now with respect to FIG. 15, the interface means 200 is capable of flexing up to about 20 degrees with the head unit force generally. For example, FIG. 15 illustrates an interface member 200 having a sealing member 202 and a support member 204. Preferably, the support member 204 is sufficiently flexible to deform about a median plane M. The interface member 200 shown in FIG. 15 is a top view, also shown in FIG. 14 in perspective view and FIG. 23rd - Side view. As illustrated, the illustrated interface means 200 typically has a triangular view as in FIG. 15 in top view. Further, in this view, the notch 306 is formed along the base of the triangle 308. Of course, the notch 306 is formed to accommodate at least a portion of the patient's nose. FIG. In the side view 23, the interface means 200 has a square or cut pyramid shape. In some configurations, no significant notch along the interface can be identified when viewed from the side. The illustrated configuration results in an interface tool that is significantly more flexible about a mostly vertical median plane than flexibility about a substantially horizontal extending plane. In addition, the illustrated configuration results in an interface device that is longer from top to bottom than wider from one outermost cheek to the other outermost part of the cheek and has an upper surface circumference 310 that is substantially triangular (i.e., which extends between the cheekbones, usually triangular when viewed from the front), and the circumference 312 of the lower surface, which is usually triangular (i.e., the part of the perimeter of the lower surface that extends between the cheekbones is usually triangular when viewed from the front). The circumference of the upper surface, being triangular, the circumference of the lower surface, together with the nose and the chin, which are drawn relative to the cheek, form a configuration which is considerably more flexible about the vertical median plane than that of the horizontally extending plane.

As shown in FIG. 15, the left side of the interface means 200 is repositioned to reduce the likelihood of movement 10, and a force 304 is applied. Preferably, the force 304 is applied at approximately the widest point of the interface means 200, which generally corresponds to the cheekbones. Applying a force 304, it is desirable that interface 200 deform so that angle α changes to angle β (i.e., angle change is α - β). In one embodiment, the change from a to β is at least about 10 degrees when the applied force 304 is 3 N. In a more specific embodiment, it is believed that when using the interface means, typical strap forces can cause deformation of approximately α - β = 10.⁰ up to 50 °. In another embodiment, α - β is at least about 10⁰ up to 30 ° at typical strap forces of about 1.4 N to about 15 N for each strap, calculated using four straps.

In one embodiment, a force N 30 of 1 N can deform interface means 200 by at least about 5 mm. In another embodiment, the 3 N force 304 can deform interface means 200 from about 5 mm to about 50 mm. In still another embodiment, the 3 N force 304 can deform interface means 200 from about 15 mm to about 25 mm.

In use, the deformation of the support member 204 can occur by closing or opening the shape of the interface means. In some embodiments, the force applied to open the interface means 200 at a given size may be less than the force applied to open the interface means 200 at the same magnitude. For example, in one embodiment, a force of 1 N applied in the opposite direction to the force 304 (i.e., the opening force) may deform the interface means

200 at least about 3 mm. In another embodiment, the force of 3 N of the opening may deform the interface means 200 from about 3 mm to about 25 mm. In yet another embodiment, the 3 N opening load may deform the interface means from about 10 mm to about 20 mm.

According to FIG. 12, the modulus of elasticity of the support member 204 and the seal member 202 may be mutually related. As shown in FIG. In Figure 12, it is desirable that the material comprising the sealing member 202 has a modulus of elasticity of bending of less than 15 MPa. At a level well above about 15 MPa, the sealing member 202 was found to be too rigid or too rigid. On the other hand, the flexural modulus of the support member 204 is preferably less than about 480 MPa. At a level well above about 480 MPa, the support member 204 was found to be too rigid or too rigid. Further, it is desirable that the flexural modulus of the support member 204 be above about 50 MPa. At a level well below about 50 MPa, the support member 204 would exhibit excessive bending. Finally, by determining the bending characteristics that are desirable for both the support member 204 and the seal member 202, it has been found that the desired interconnection can be found in the shaded area as shown in FIG. 12th

Flexible interface tool support

Historically, the ability of the interface tool to fit snugly on a patient's face has been hampered by difficulty in matching the patient's contours. The inability to fine-tune the interface tool to the specific contours of the patient's face results in an excessive gap between the interface tool seal and the patient's face. The tensioning of the head equipment straps in previous interface device configurations may form a force vector in the interface device, which unevenly loads the seal contact surface onto the patient's face. Due to uneven sealing surface loading, pressure points may occur in some areas and insufficient pressure in others. Pressure points can cause patient skin irritation, whereas improper pressures can cause leakage.

According to FIG. 16-21, several embodiments of interface means 200 are shown that implement a structure that enhances the ability of interface means 200 to fit the patient's face more closely. The structures also enhance the ability of the interface means 200 to match various facial contours. It is desirable to achieve as even distribution of the sealing pressure as possible by applying the composite structure to the interface means 200. Thus, the interface means 200 may flex and deflect to accommodate different facial contours while allowing the sealing member 202 to inflate or stretch between the support member 204 and the face, thereby more evenly distributing the head unit mounting force to the interface member between the sealing member and the skin.

As shown in FIG. 16, the patient interface means 200 comprises a soft, eligible sealing member 202 and a support member 204 as described above. The sealing member 202 is adapted to cover the nose and boom and to isolate the face along the perimeter edge 206 of the sealing member 202. Most of the interface means 200 shown in FIG. 16, is the same as interface means 200 shown and described with respect to FIG. 2. In particular, hereafter FIG. The features described in FIGS. 16-21 may be implemented, for example, by interface means 200, which are installed and configured in accordance with the descriptions found anywhere in this application.

An additional support member 404 is provided above the sealing member 202 or support member 204 to form a support for the sealing member 202. The wall thickness of the auxiliary member 404 and the sealing member 202 is small and formed in a complementary manner so that the sealing member 202 fits closely under the support member 404. Preferably, in at least one embodiment, the outer profile or shape of the support member 404 and the sealing member 202 substantially conforms to a typical face contour such that the interface member 200 has a relatively low profile portion. In some embodiments, the patient interface tool 200 may be more specific in size and dimension.

The support member 404 has a central hub portion 470 that is connected to the support member 404. In some configurations, the central hub portion 470 may be directly connected to the sealing member 202. A plurality of replacement members 472 or "fingers" spaced apart extend outwardly from the hub portion 470. Preferably, the replaceable members 472 are secured at one end to the hub portion 470 and extend outwardly toward the perimeter edge 206. Preferably, the replacement members 472 are not rigidly connected or attached to the main sealing member 202 such that relative slip moment can occur between the bearing member 204 of the sealing member 202 and the replacement members 472.

In some embodiments, the replaceable members 472 may be hinged rather than rigid. In this configuration, the replaceable members 472 move relative to each other substantially forward and backward (with respect to the face when the interface member 200 is worn) such that the force applied to the hub portion 470 by the head equipment accelerates the interface member 200 toward the face.

Preferably, the replaceable members 472 are made of a material that is significantly harder than the soft material of the seal member 202. For example, typical polymeric materials used for the interface device frame may be suitable, including, but not limited to, polypropylene, polyethylene or polycarbonate. The replaceable members 472 in one embodiment may comprise an elastic material extending between two adjacent edges of the adjacent fingers 472 in a manner similar to that of a trap glove. In other words, the woven band of the elastic material may extend between adjacent fingers 472.

The function of the plurality of replaceable members 472 is to distribute the load applied to the center hub 470 over the wider surface of the interface means 200, thereby providing a more localized force to press the peripheral 206 edge of the sealing member 202 against the wearer's face. In particular, because the replacement fingers 472 are fixed at one end to the hub 470, and because the free fingers 472 move back and forth with the free ends, the support member 404 having the replacement members 472 may conform to the face and may provide a good fit facial contours. The sliding movement of at least the free ends 474 of the replaceable members 472 relative to the main sealing member 202 provides a mechanism by which the members 472 may exert pressure on slightly different portions of the sealing member 202 depending on the different contours of the wearer's face. Such a design can increase the adaptability of a particular sealant to various facial contours.

If the wearer has a relatively flat face, it is easier to achieve good tightness.

However, if the wearer has a face with large deformations, the free ends 474 of the replaceable members 472 exert localized pressure forces at locations distant from the relatively central hub 470 such that forces from the headgear may be transmitted from the hub to the free ends 474.

In some configurations, the hub members 470 may be disposed off-center on the interface means with each hub member 470 having extensions therefrom 472. For example, the chin and the left and right cheeks are acceptable locations to overload the user's face, and the interface member may have hub members. 470 in one or more of these locations.

Referring to FIG. 18, for the support element 404 shown in FIG. 16 and 17, another support member 480 may be applied. In some configurations, support member 480 may be attached to support member 404 to form a laminate-like structure. The support member 480 may comprise a plurality of replaceable members 482 that move relative to each other and / or at least inside the hub member 484 of the other support member 480.

Preferably, the fingers 482 of the other support member 480 touch the fingers 472 of the support member 404. Although the illustrated configuration shows the same number of replacement members on the support member 404 and the additional support member 480, the number and arrangement of the replacement members may vary. In some embodiments, a plurality of replaceable members associated with the other support member 480 may be located directly on the sealing member 402.

It is understood that embodiments may be constructed with combinations. In other words, some of the plurality of fingers (either the support member or the additional support member) may be positioned directly on the seal or may be located on the other fingers. For example, interface tool 200 shown in FIG. 16, has a support member 204 inserted between the seal member 402 and the support member 404 (and / or another support member (not shown)). In this embodiment, the free ends 474 of the support member (and / or other support member) rest on the support member 204, which in turn applies pressure to the main sealing member 402. The supporting member 204 serves to further distribute the load forces downstream of the sealing member 402 and / or for supporting the sealing member 402.

FIG. 19, the free ends 474 of the support member (and / or other support member) may rest directly on the eligible bottom sealing member 202. FIG. In the embodiment shown in Fig. 20, the finger free ends 474 are based on the main replaceable members 482 of the other support member. Any other suitable variants may also be used.

The above description provides only a few examples of the interface tool sealing types where the replaceable elements 482 can provide better face fit and / or improved sealing. Other configurations are also possible. The number, spacing, and width of the replaceable elements can vary. In addition, although all embodiments illustrated in FIGS. 16-21, illustrated support elements (and other support members), which are generally circular in plan view, and / or illustrated replacement elements, which generally extend from a central location, are possible in other forms. For example, linear or usually quadrilateral hubs may be used instead of the central hub. In such embodiments, the replaceable members 474, for example, may extend from the center to the outside, similar to a leaf structure or as a tree branch, as shown in FIG. 21, but not limited to. In such embodiments, it is desirable that the hub be substantially aligned with the medial sagittal plane when the interface wearer is worn by the user. In addition, the hub may have one or more semi-rigid reinforcing ribs 492 to substantially strengthen the base of the structure. The presence of the base reinforcing rib 492 forms a rod to resist bending in the specified direction.

In another alternative embodiment, the replaceable members may be constructed with variable thicknesses to accommodate the stiffness of the parts mounted at one end relative to the forward and backward bending. For example, the thickness of the finger material may decrease toward the free ends. In addition, the fingers may or may not have a substantially rectangular plan profile as shown in the drawings. For example, the width of the replaceable elements may decrease towards the free ends or may have different shapes to achieve the desired level of displacement.

In yet another alternative embodiment, the free ends of the replacement members described above may further have features where the free ends rest on the sealing member or additional support member. For example, the compressible material gasket may be arranged between the free end and the sealing surface so that the compressible gasket rests on the sealing member. In another example, the free end may be rounded at the point of contact between the free end and the sealing member. On the other hand, the free end may have an adaptive member which rests on the seal. The adaptive member may be, for example, of foam or a plurality of small compressible rings.

An example of an interface tool abutment is described above that can be used in conjunction with the previously described reconstituted nose interface tool. The interface tool support can be used with other interface tool configurations that have a soft adaptive seal. For example, it is not necessary to have a support member between the spacer and the replacement members. In at least one embodiment, this configuration is appropriate.

In other words, the replaceable support members may act directly on the adaptive seal at specific locations to press the interface means seal against the wearer's face. Similarly, the UI support is not limited to application to any single head unit configuration. The general purpose of the interface means support is to distribute a large area of ​​the force applied to the head unit substantially in a single location, and the disclosed configurations may determine means for distributing localized force across the interface means housing. In particular, the interface device support can distribute power over a large area and / or accommodate very different face contours.

Breathing tube connections

Now based on FIG. 14 and 22, the breathing tube 500 is shown connected to the interface means 200 in at least two different ways. The described connections between the breathing tube and interface may be interchangeable. In addition, any described connector may be used with any of the described interface devices.

Initially with respect to FIG. 22, the illustrated breathing tube 500 is connected to the breathing tube connector with the elbow 504. The breathing tube connector may be mounted and sealed on the opening 242 of the sealing member 202 As the breathing tube connector is secured to the opening 242, the breathing tube connector extends through an opening 266 in elements 204.

In some configurations, a click-type coupling mechanism is used wherein the semi-rigid portion of the connector 5 protrudes through the opening 242 in the sealing member 202 on one side of the sealing member 202 while the other semi-rigid portion of the connector may be clickably connected to the first semi-rigid member. In some configurations, any other suitable connection method may be used to form a projection on the soft adaptive sealing member 202, and the joint may be connected to the projection.

Elbow 504 may be connected to the connector.

FIG. 22 shows an interface member 200 with a breathing tube 500 connected to an elbow joint 504, the connector may be connected to a sealing member 202 or a sealing member 202 and a support 204. The cam linkage 502 allows the elbow 504 to rotate relative to the interface member 200. may occupy different orientations with respect to the interface means 200, thus, for example, but not limited to, improving user comfort during movement. Another sham joint 506 may be provided between the elbow 504 and the breathing tube 500.

The interface means described herein can also be used with a two-way flow fan with a channel 500 short and connected to a Y-shaped nozzle. Further, in a one-way flow system, such as a positive airway pressure system (CPAP), suitable vents may be provided at the elbow 504 or adjacent the nasal tip region of the sealing member 202. In addition, a ball-type joint may be used in place of the sham joint 502, allowing an interface between the breathing tube 500 and the interface means 200.

In some configurations, such as those shown in FIG. 14, the interface means 200 may include a valve 520 prior to suffocation. The valve 520 prior to suffocation may be associated with the interface means or, in some embodiments, may be inserted, for example, but not limited, into the airway connector or elbow connector.

Although a usable connector using the elbow 504 provides a substantially horizontal inlet of breathing gas to interface means 200. Thus, the breathing gas enters directly into the patient's boom. This configuration was found to have several drawbacks. For example, patients may feel uncomfortable with breathing gas directed directly to their face or boom. In addition, the elbow connector 504 is attached to the interface means 200 at the front and protrudes outwardly away from the user's face. The apex of interface device 200 (i.e., nose portion 220 of interface device 200) where the sealing member 202 interacts with the nose is a portion that is difficult to fit tightly due to the large anatomical differences between patients. The nose ridge is the common drainage point of the interface device. Any rotation of the interface means 200 can aggravate the sealing problem in this area. To compensate for this effect, it is common practice to tighten the head unit straps to tighten the interface device 200 to the patient's face. Overdrive can cause discomfort, which is highly undesirable.

Further with respect to FIG. 14, in this embodiment, the connection to the breathing tube 500 may be made through a short flexible tube 522 which directly connects to the breathing tube and which enters the interface means 200 in close proximity to the wearer's chin and angle (protruding downward from the wearer's chin). Thus, the gas introduced into the interface means directed upward and into the patient's boom and nose. In other words, tube 522 extends downward and away from the patient.

The flexible tube 522 is connected to the interface means through an opening 525. The opening 525 is below a line extending outwardly through the patient's boom when viewed downward in its normal position. Preferably, the tube 522 enters the interface means 200 through an opening 525 at an angle of about 0 ° to about 70 ° vertical. In some configurations, the input angle is from about 50 ° to about 60 °. Preferably, the inlet angle is approximately 55 °.

Preferably, the gas port 525 is located near the patient's chin (i.e., between the patient's lower lip and chin tip). This slot position occupies a useful position because the front of the interface device 200 has more options for attaching equipment such as openings, posts, loops, brackets, and the like. In addition, this orifice location also allows the valve 520 to be fitted to the mouth prior to suffocation. In addition, the location of the breathing gas inlet 525, located near the lowest point of the interface means in use, provides effective vomiting drainage.

The short length of the tube 522 allows the patient to move his head naturally with great flexibility and to form a junction between the patient interface device 200 and the respiratory tube 500 at a distance from the interface device itself. The connection between the patient interface device 200 and the respiratory tube 500 may be made by rigid connections of known type. The placement of these connections at a distance from the patient's chin and neck improves the patient's head mobility, especially when the head is tilted forward.

Any other suitable method of supplying compressed gas to the interface means may also be used.

Interface flow control

Now with respect to FIG. 24 and 25, flow diffusion and control inside interface means 200 will be described. The interface means 200 may be configured in any suitable manner and, as shown in the drawing, for example, but not limited to, the interface means 200 may include a cavity 600 defined by a sealing member 202 within the interface means 200. The sealing member 202 may be configured in any suitable manner, including but not limited to those described in this application. In use, the sealing member 202 contacts and fits snugly against the patient's face. A tightly pressed face sealing member 202 reduces the likelihood of air or gas leaking from cavity 600.

The respiratory tube or other short flexible tube 104 is connected to the interface means 200 by any suitable means, including but not limited to those described in this application. The breathing tube 104 supplies the breathing gas to the inlet 602. Preferably, the inlet 602 is located in the area of ​​the interface means 200 which will be located near the patient's chin. Better yet, the inlet port 602 is configured so that the breathing gas is directed upward rather than directly into the patient's face.

Referring to FIG. 24, the cavity 600 defined by the sealing member 202 may be redistributed by the baffle 604. The baffle 604 may be formed in the cavity 600 by any suitable means. Preferably, the baffle 604 is formed or supported in the cavity 600 into the projection 606 or otherwise mounted. In this configuration, the baffle 604 is mounted at a location within the boundary of the baffle 608 of the baffle 604. In the shown configuration, the entire periphery 608 is spaced from the inner wall of the sealing member 202 or other interface means defining the cavity 600.

The partition 604 may be branched from the inner wall so that the gap is defined by the partition 604 and the inner wall. Preferably, the septum 604 is approximately in the form of a common cavity 600 such that the pressure space is defined by approximately a constant distance between the septum 604 and the inner wall. Preferably, the clearance between the inner surface of the bulkhead 604 and the cavity 600 is less than about 10 millimeters. More preferably, the gap is from about 3 millimeters to about 6 mm. In some configurations, the associated angle between the flow from orifice 602 and the septum wall is from about 30 ° to about 80 °. In some configurations, the associated angle is from about 50 ° to about 70 °. Preferably, the associated angle is about 60 °.

The diffuser orifice or diffuser outlet 610 may be defined by a gap between the peripheral 608 of the baffle 604 and the inner wall. In some configurations, the baffle is generally round and has a diameter of about 30 mm to about 100 mm. In configurations, the diameter is from about 40mm to about 80mm. Preferably, the periphery 608 of the baffle is sized and spaced so as to extend close to the outer circumference of the sealing member 202. Even more preferably, the periphery 608 of the septum 604 extends into an area partially enclosed by an expanded surface 210 defined by the flange 208.

It is also desirable that the baffle 604 be in the lower part of the cavity 600. More preferably, the upper edge 612 of the septum 604 is disposed at or below the cheekbone level of the interface device 200. More preferably, the upper edge 612 of the septum 604 is substantially aligned with the lower portion of the notch 252 for the nasal portion 220. Therefore, the upper edge 612 may be disposed generally at the same location as the patient's nose.

In the embodiment shown, the diffuser outlet 610 is substantially or completely adjacent to the entire baffle 604. In some cases, the diffuser outlet 610 may be defined individually along the upper edge 612 of the baffle 604. In some configurations, the diffuser outlet 610 includes an area along the top edge 612 such that the diffuser outlet 610 includes an upper portion of the diffuser opening that causes the breathing gas to flow substantially tangentially through the wearer's cheek region.

However, in some configurations, the baffle 604 does not extend along the contour of the inner surface of the sealing member 202, so that the gap between the baffle 604 and the inner surface of the sealing member 202 is substantially non-constant.

Inlet 602 supplies gas from the breathing tube to the pressure space defined in cavity 600. Inlet 602 leads to a pressure chamber defined between the baffle 604 and the inner surface of the sealing member 202, or wherein the sealing member 202 is replaced by a support member 204. Thus, the gas introduced through the inlet 602 generally obstructs the baffle 604 to flow directly into the patient boom.

More precisely, the gas flow acts on the baffle 604 and is directed through a low pressure chamber.

Where the inner wall defining the cavity 600 and the septum 604 approaches the contours of the wearer face, the diffused breath gas stream exits the pressure chamber through a diffuser port 610 defined between the inner cavity wall and the periphery 608 of the septum 604.

The pressure chamber acts as a means of evenly distributing the flow of respiratory gas to the patient along the edges of the septum without substantially increasing flow resistance. In interfaces that include an inflatable or stretchable seal, the diffuser opening 610, which directs the flow radially outward from the inlet 602, instead of directing the flow along the axis of the inlet 602, directs the flow toward the circumference of the sealing member 202 which assists in clamping the flange. 208 to the patient's face.

In some configurations, partition 604 may be secured at different locations (e.g., at least two or more locations). The baffle 604 may be secured such that the diffuser opening 610 includes different areas along the periphery 608 of the baffle 604 and / or along the top edge 612, the opening being not a single open channel. In other words, the diffuser orifice 610 may not be a continuous orifice extending substantially around the perimeter 608 of the baffle 604.

Preferably, the total cross-sectional area of ​​the diffuser port (s) 610 is greater than the cross-sectional area of ​​the breathing gas inlet port 602. In such an embodiment, the gas velocity is reduced from the inlet 602 to the diffuser port 610. Preferably, the cross-sectional area of ​​the diffuser port 610 is at least twice the cross-sectional area of ​​the inlet 602. More preferably, the cross-sectional area of ​​the diffuser orifice 610 is 2 to 5 times smaller than the cross-sectional area of ​​the orifice 602. The increased cross-sectional area reduces ventilation synchrony issues and jet effects on patients. For example, diffused and / or retarded gas flow, together with directing gas flow to the wearer's skin, causes the patient to feel more comfortable.

In some configurations, partition 604 may have one or more small holes.

The holes allow breathing gas to flow gently straight into the boom. In addition, in some cases, the pressure chamber may have flow directing functions, such as baffles or the like, to concentrate flow on specific areas of the face. For example, the flow may be diverted away from the patient's receptor area, which usually enhances unpleasant feelings during treatment. In addition, in some cases, flow may be directed to areas of the patient's receptors that may relieve sensation, shortness of breath, or air deficiency. And in some cases, the flow can be diverted from the nose using the flow diversion feature. The flow deflection functions may be related to the inner surface of the cavity and / or the septum 904.

Preferably, the interface means 200 will also have a valve 520 prior to suffocation. In some configurations, valve 520 may be incorporated into the baffle retaining projection 606. Additionally, in some cases, baffle 604 may be flexed, moved, or rotated such that inbound flow is diverted by baffle 604 and exhalation directed directly to the orifice.

In some embodiments, the interface means 200 may have one or more pressure control openings (not shown) disposed on the outer surface of the interface means 200. The pressure control openings could pass through the pressure chamber and open into the gas cavity 600. In other words, it is desirable to place the orifice in the gas cavity 600 outside the pressure chamber defined between the septum 604 and the inner surface of the cavity. Even better, the opening is located along the bulkhead 604 on the opposite side of the pressure chamber to the bulkhead 604. Arrangement of pressure control aperture behind screen or baffle 604, but may improve pressure control accuracy in front of patient's face. Such arrangement also improves respiratory rate or similar when ventilator is used.

Partition 604 was found to significantly improve acoustics associated with patient 5 language. The pressure chamber, defined by the compensation partition 604, has been found to improve the acoustics of the interface device, which allows the patient to hear more easily when speaking. In addition, allowing the flow to the interface means the patient does not need to overcome the nasal and / or boom to speak. In other words, the patient does not need to defeat the incoming flows from the ventilator in order to speak.

In addition, the arrangement of the pressure chamber due to airflow diffusion in the baffle 604 can help reduce condensation in cavity 600. In addition, the configuration flow dispersion described in this application has been found to reduce the accumulation of unwanted water vapor, water droplets and mobile water on the interface. probability of instrument surfaces. The diffused air stream, condensed water, or other liquid may be directed for removal from the cavity 600 and directed toward the orifice or other collection or discharge site.

Now with respect to FIG. 25, further illustrates the flow scattering configuration. In this configuration, the breathing gas entering the interface means 200 is rotated in a spindle cavity 600 to form a cyclonic movement, preferably substantially tangential to the patient's face.

The interface in the cavity 600 of the device 200 is a gas. The sealing member 202 is configured to contact the face and substantially isolate the cavity 600 in front of the face. Breathing gas entering through port 602 is located near the chin. The respiratory tube distributes gas through an inlet 602 into the inhaled gas as described elsewhere herein.

The breathing gas inlet may be located within the gas vortex structure 620. The vortex structure 620 comprises a substantially cylindrical wall 622 extending substantially perpendicular to the interface means cavity wall. In other words, when the patient is standing upright, the cylindrical wall 622 protrudes substantially before the patient boom. The nearly conical wall 624 extends coaxially with the cylindrical wall 622 and the vortex space 626 is defined between the cylindrical wall 622 and the conical wall 624. The tapered wall 624 is angled so that the larger circumference of the tapered wall 624 is closer to the user interface means.

In use, the breathing gas enters the vortex space 626 through the opening 602 in the tapered wall 624. The opening 602 is located at a branch away from the axis of the walls 622, 624 such that the gas stream enters the vortex space 626 from the branches and approximately tangent. As a result, the gas flow in the illustrated annular vortex space 626 rotates counterclockwise to form a rotating flow. The tilted conical walls 624 accelerate the rotating flow towards the patient (i.e., in the direction of FIG. 25 from the side). As the flow rotates and moves toward the patient, the gas stream pivots the top of the tapered wall 624, resulting in a purifying air band moving outward and inward relative to the patient's face. The resulting flow at the wearer's face is diffused and preferably traveling slower than the gas stream entering the vortex structure. In some configurations, the airflow velocity toward the patient's face is less than about 8 m / s. In some configurations, the airflow velocity toward the patient's face is less than about 6.5 m / s. Similar to the pressure chamber embodiment described above, patient comfort is improved.

Head equipment

The interface device 200 can be mounted on a patient using any suitable head unit kit 700. Several different head unit sets will now be described with reference to the drawings.

Initially with respect to FIG. 26, it can be seen that head unit assembly 700 is used to limit movement of interface means 200 generated by the configuration of compressed gas flow inserted between patient P and interface means 200. The force vector R1 originates from the configuration of interface means 200 and gas flow to interface means 200. It is conceivable that the smoothing vector EI extends in the opposite direction. Ideally, a single strap can be used to attach the interface means 200 to the face as long as this strap is along the line of action of the smoothing vector EI. Depending on the desire to capture the chin, a holding line in the LR can also be imagined. The retention line LR runs along the upper portion of the ears and through the center of the interface area 200.

Preferably, interface device 200 is preferably supported on at least three parts of the patient's face: left cheekbone, right cheekbone, and chin. Preferably, the strap attachment positions on the interface means 200 approximately correspond to the vertical positions of the cheekbones for the upper straps and the chin area for the lower straps. This configuration provides a symmetrical force model whereby the head unit retains the interface tool on the patient's face.

While some of the headpieces 700 to be described may have one strap extending generally along the holding line LR, other headpieces 700 may have two or more straps (e.g., Figures 13, 16, 22, 23, 26, and 27). For example, FIG. In configuration 16, the head unit 700 comprises a strap extending in two directions from the interface means 200 to attach the interface means 200 to the face of the user. Although the strap is shown on one side for convenience only, a similar strap would be used on the other side of the interface means or the same strap could extend on both sides of the interface means 200.

Now with respect to FIG. 13, 22 and 27 show other examples of head unit 700 which may be used to mount interface device 200 on a patient. This head equipment

700 is provided for illustration, and other types of head equipment may be equally appropriate.

Slit, hook and loop fasteners

FIG. In Example 22, head equipment 700 comprises an upper strap 702 and a lower strap 704. The upper strap 702 extends around the patient's head above the ear. The lower strap 704 extends around the patient's neck below the ear.

Each strap 702, 704 is attached to the support member 204 of the interface means 200. The straps 702, 704 may be secured to the support member 204 by passing through the clips. However, in some cases, straps 702, 704 may be secured to support member 204 by slots 706, which may be formed in support member 204. In particular, free ends 708 of straps 702, 704 may pass through slots 706. The free ends 708 of the straps 702, 704 may be retracted by folding back, for example, but not limited to, hook and loop fasteners such as Velcro® or the like. Other suitable completion methods may also be used.

In some configurations, the upper strap 702 may be attached to the support member 204 in the lower region, and the lower strap 704 may be attached to the support member 204 in the upper region. In such configurations, the straps 702, 704 intersect on the patient's head.

Interface tool with integrated strap parts

Referring to FIG. 13, a support member 204 is shown having continuous extending strap portions, such as upper extending strap portions 710 and lower extending strap portions 712. Each extending strap portion 710, 712 may terminate in a strap attachment assembly (e.g., upper strap 702 and lower strap 704). ). Such a unit may be in the form of a cut-out 714. Other nodes are also possible. For example, the upper and lower ends of headband straps 702, 704 and integral strap parts 710,

712 the ends may have suitable additional connectors, buckles and holes or the like.

Single point adjustment

FIG. Figure 27 shows another configuration of head unit 700 in which head unit 700 may be more readily adjustable. The tension adjustment of the desired position and / or interface means 200 is desirable. Existing regulatory proposals include combinations of regulatory mechanisms, such as, but not limited to, loops and hooks described with reference to FIG. 22 and 13. The combination of adjusting mechanisms is connected to two, three, four or more separate anchorage points on the interface means 202. Each connection to each anchorage point must be adjusted by a separate process to achieve a generally symmetrical arrangement and loading of the interface means 200.

Referring to FIG. 27, the head unit 700 and the adjusting system include at least one slider between the head unit 700 and the interface means 200. Preferably, the at least one slider is provided with an upper slider between the upper strap 702 and the upper portion and lower slider of the interface member 200. FIG. communication between lower strap 704 and lower part of interface means 200.

The sliding links may include a line 716 crossing the outer surface of the interface means 200. Line 716 connects head unit straps 702, 704 on each side of interface means 200. Line 716 may be slidably secured in slip clamps 718 on the outside of support member 204. Preferably, the materials selected for line 716 and for clips 718 have a low friction contact so that line 716 can move or slide easily relative to clamp 718. In some configurations, line 716 may be wholly or partially enclosed in the form of a hose or tube to protect the slide mechanism and / or reduce the likelihood of objects (e.g., hair) entering the control mechanism.

Preferably, clips 718 lock line 716 to reduce the likelihood that line 716 will separate from clips 718 or interface means 200. A fixed but sliding line 716 allows the head unit and interface means 200 to remain engaged, e.g., when interface means 200 is removed from the head. or face. Preferably, the clips 718 allow the interface means 200 to be removed from line 716 if it is desired that line 716 remain attached in other respects and under normal conditions of use.

Preferably, the clips 718 are disposed to guide line 716 through the entire interface means 200 below the level of the nose portion 220. The clips 718 may also be used to push the interface means between the ends of the lower strap 704. Lower clips 718 guide line 716 through the entire lower portion of interface means 200.

In some configurations, the clips 718 may include one or more rotating pulleys to further reduce friction and enhance slip (i.e., relative movement between line 716 and interface means 200). In this regard, the term "sliding" was used to describe extensively the relative movement between line 716 and interface means 200. For example, but not limited to, low friction in the circuit of line 716 allows line 716 to maintain voltage throughout the loop defined by line 716 when interface device 200 and / or head unit moves on face or head during use.

Referring to FIG. 27, one control line 716 passes through sliding connectors 718 on interface means 200 and through sliding connectors 720 on right and left sides of head unit 700. The two end portions of the adjusting line 716 may be provided together in the buckle 722. The ends 724 of the control line 716 can be pulled sideways by further pulling the control line 716 through the buckle 722, thereby reducing the loop length of the control line 716 and thus tightening the device on the patient (i.e., increasing the voltage). Buckle 722 may allow control line 716 to pass through with sufficient voltage. The buckle 722 may be in any suitable shape. In some configurations, buckle 722 may be a retractable key ring type member, a clamp, a clamping wedge, a cam wedge, a wheel, or a slip mount type ratchet mechanism or other suitable adjusting mechanism.

In some configurations, only one end of the control line 716 is adjustable through the buckle 722. The other end of the control line 716 may be secured. In some configurations, such as but not limited to, the other end of the adjusting line 716 is fastened to the buckle 722, the interface means 200, one or more straps, or the interface means 200 together with the buckle 722.

In some configurations, buckle 722 may have a predetermined or adjustable limit on the voltage that the loop can maintain. In such configurations, the clamping voltage limit can be used to set the limit on the amount of force the restraint system can exert on a user's face. The clasp 722 may also include a caster rotatably secured to a support member 204 with an adjusting line 716 wrapped around the caster so that rotation of the caster in one direction tightens the loop defined by adjusting line 716, while rotation of the caster in the other direction releases the loop defined by adjusting line 716. In this embodiment, the ratchet or release mechanism may be retracted to maintain the alignment line 716 in place when not adjustable by the dial (i.e., when the release mechanism is locked).

In some configurations, interface device 200 and loop 716 may have only one connector 718 disposed along the top of support member 204. Preferably, a single joint 718 is disposed longitudinally or relatively close to the center plane. In some configurations, multiple connections 718 may be distributed along interface means 200, and line 716 may be routed only through a portion of multiple connections 718. In this way, the loop shape defined by line 716 can take various forms. As a result, the angle of line 716 extending toward the head unit strap portions 720 may be controlled, and the loop defined by line 716 may be directed around the ears or other anatomical features of the patient to improve comfort and / or compliance.

As described, the head unit 700 shown in FIG. 27 and above is characterized by a single and simple adjustment of the interface means to the head unit interface. In other words, a single adjustment point can be effective in reducing and / or increasing the actual size of the patient interface device to suit users of various sizes and anatomical contours. In addition, one adjustment point is all that is needed to control the voltage on the interface device. In particular, one adjusting point in the configuration shown allows the interface device and head unit to remain symmetrically positioned on the face under tension control line 716, while allowing for some slip during use and pressure boosting of the sealant.

One advantage of the interface means 200 and the head unit 700 in characterizing line 716 is that the interface means 200 and / or head unit 700 may be adjustable when the head unit 700 and the interface means 200 are on the head and face. This greatly improves the ease of use of the interface device 200 and head unit 700 and simplifies adjustments that provide additional patient comfort. Quick installation and adjustment of interface device 200 allows you to begin treatment as quickly as possible. In addition, this regulatory system is adaptable to many different head unit configurations and many different types of patient interface tools.

Easy to apply head equipment

FIG. 26 illustrates a head unit 700 that can be quickly and easily mounted on a patient and / or controlled either by the patient or by a health care professional.

Preferably, with most of the interface means, and in particular the interface means 200, which has an inflatable seal, the head unit 700 will have only a small amount of tension. In other words, it is desirable that the head unit 700, where it connects to the interface means 200, is not stressed or nearly stressed. However, interface means having an inflatable seal may be particularly difficult to apply at an appropriate level of tension by pulling interface means 200 on the patient's face. For example, if interface means 200 is applied to a patient without respiratory gas flow to interface means 200, the voltage required to maintain interface means 200 conveniently on the patient's face may be insufficient to reduce the likelihood of substantial leakage when breathing gas is delivered.

Referring to FIG. 26, patient P has interface device 200 applied to the mouth and nose. Head equipment 700 includes two generally inelastic connecting straps 730 on each side of interface means 200 and two typically elastic connecting straps

732 on the 200 side of each interface tool. The connecting straps 730, 732 are connected to the interface means to maintain the balance of the head unit 700.

The inelastic connecting straps 730 are attached at one end to any suitable head unit 700, including the sheath head unit 734, and preferably the inelastic connecting straps 730 are connected to the interface means 200 with adjusting mechanism 736 which allows the length of the inelastic connecting strap 730 to be varied. that is, allows adjusting the length of the connection between interface device 200 and head unit 730). In some embodiments, the adjusting mechanism 736 may be provided at the end of an inelastic connector strap 730 that engages the interface means 200 with the head unit 734. In any case, it is desirable that the adjusting mechanism 736 be located so as to manipulate the patient's head while resting. on a pillow or other structure such that the regulating mechanism 736 can be manipulated without moving the patient's P head.

The adjusting mechanism 736 may have any suitable construction. In some configurations, the adjusting mechanism 736 comprises a friction buckle attached to interface means 200 through which inelastic connecting straps 730 pass. probability. When adjustment is required, the friction member may be disengaged from the connecting strap 730, thereby allowing the straps 730 to be extended as desired. The friction clasp provides a simple mechanism 736 that can be easily operated with one hand. In some configurations, the adjusting mechanism 736 may include, but is not limited to, a step lock, a buckle, a ratchet mechanism, a clamp, a cam wedge, or a pin and hole coupling.

A wide variety of adjusting mechanisms 736 can be offered to adjust the length of the relatively inelastic connecting straps 730. For example, friction buckles and cam shapes of various shapes may be particularly suitable configurations where the strap 730 is a rope, cord, or the like, other forms of adjustment may be more suitable, particularly where the strap 730 is semi-rigid. For example, a slide ratchet ratchet mechanism or other ratchet locking mechanism may be used where appropriate.

In some configurations, the regulating mechanism 736 is of the blocking type having at least two modes. In the first locking mode, the substantially rigid connecting straps 730 cannot be extended. In unlocked mode, the strap 730 can be adjustable in both directions (ie lengthen and shorten). In some configurations, the strap 730 may be shortened when the respective adjusting mechanism 736 is in locking mode, but the strap may not be extended.

In some configurations, the likelihood of lengthening and shortening the respective straps 730 in locking mode may be reduced. In some configurations, all adjusting mechanisms 736 are disposed on the interface means 200. Preferably, all adjusting mechanisms 736 are located on the front surface of the interface means 200. This arrangement of adjusting mechanisms 736, for example, would make it easier to adjust the length of straps 730 while Patient P remains lying with his head resting on the pillow.

The relatively elastic upper and lower connecting straps 732 may be arranged 10 parallel to the relatively inelastic connecting straps 730 such that both sets of straps 730, 732 extend between the interface means 200 and the head unit 734. In other words, the relatively elastic connecting strap 732 is attached to the head unit 734. at one end and also attached to interface means 200 at the other end. The attachment locations of the relatively elastic straps 732 may substantially coincide with those of the relatively inelastic straps 730. However, in some configurations, the attachment points may be in the branches so that the inelastic and elastic straps 730, 732 are respectively connected to the head unit 734 and the interface means 200 at different locations.

It is desirable that the relatively elastic connecting straps 732 be stretched (i.e., stretched). In some configurations, the length of the relatively elastic straps 732 can be stretched from about 1.5 times to about 3 times the unstretched length. Preferably, the length of the relatively elastic straps 732 could be stretched to about twice the unstretched or free length. It is desirable that the length of the relatively elastic straps 732 be adjusted differently than the stretching of the strap material.

The parallel arrangement of the relatively elastic straps 732 and the relatively inelastic straps 730 facilitates the two-stage installation process. The relatively elastic straps 732 allow rough installation prior to final assembly using relatively inelastic straps. In some emergency situations, respiratory therapy should be initiated as soon as possible. To achieve a rapid onset of treatment, the desired installation procedure begins by holding the interface means 200 to the face of patient P before mounting the head unit 700 on the face of patient P. In some mounting methods, the mounting procedure is performed essentially with the patient's head (ie, substantially aligned with the patient's medial sagittal plane).

The method of mounting the interface device 200 on a patient P may include: (1) grasping the interface device 200 with one hand and the head unit 700 with the other hand; (2) arranging interface means 200 in front of the patient's boom and nose to initiate treatment as soon as possible (i.e., to release therapeutic airflow); (3) retracting the head unit 700 through the patient's head until the desired head unit position is approached; (4) releasing the interface means 200 and / or head unit 700 until the relatively elastic straps 732 provide sufficient tension force to hold the head unit 700 on the head and the interface means 200 on the face while relatively inelastic connections remain loose; and (5) final adjustment of head unit 700 and interface means 200 by relatively inelastic straps 730. During the final adjustment, the relatively inelastic straps 730 can be tensioned to the required level by adjusting the length of the relatively inelastic straps 730 and securing the required level or length by adjusting mechanisms 736.

The parallel arrangement of the relatively elastic link straps 732 and the relatively inelastic link straps 730 allows the head unit 700 to be positioned so that it remains in place without human intervention until the final adjustment is adjusted by the relatively inelastic straps 730. The relatively elastic straps 732 allow a high degree of movement equipment 700 so that the head equipment 700 can be placed lightly on patient P's head and above the ears. Preferably, the holding force provided by the relatively elastic straps 732 is sufficient to mount the interface means 200 on the patient's face and head equipment 700 on the patient's head. Although it is not necessary to provide sufficient tension to seal the interface device to the face with relatively elastic straps 732, in some cases, the elastic holding force provided by the relatively elastic straps 732 may be high enough to press the interface device 200 tightly against the face during use. Nevertheless, it is desirable that the configuration could be easily used for a variety of patient head sizes.

The relatively inelastic connecting straps 730 are provided to reduce the likelihood of tensioning the head unit 700 during ventilation when the straps 730 have been adjusted to the required tension or length. Slight stretching of elastic straps can cause slight pressure loss inside the mask. A slight pressure drop may cause the fan response to produce a throbbing gas supply due to elastic tension of the head unit or elastic coupling between the head unit and the interface. For this reason, a substantially inelastic head unit and a connection between the head unit and the interface device are required. When using interface means having an inflatable seal, the required tension or length for relatively inelastic connecting straps 730 can be set while the gas flows into the interface means and while the sealing member 202 is blown.

Although in the previous embodiment the interface device 200 and the head unit 700 were provided with both upper and lower straps on either side of the interface device 200, one set of parallel elastic and non-elastic straps 732, 730 may be formed or the straps may be in only one interface device 200. side. In some configurations, the arrangement of parallel elastic and inelastic straps may be provided for only one upper or lower set of straps on each side, whereas one strap (either elastic or inelastic) may be provided for the other. In some configurations, the arrangement of the parallel elastic and non-elastic straps may be provided on only one side of the interface means, while the other may have only one strap (elastic or inelastic).

Further, in some cases, the arrangement of the parallel elastic and inelastic straps 732, 730 may be provided without the upper and lower straps, with only one level strap. In some configurations, the upper strap may be attached to the interface device in the lower area, and the lower strap may be attached to the upper area. In this configuration, the straps are crossed behind the patient's head.

The above described method of mounting the interface device 200 on a patient P is only a guideline and can be modified and even remade. For example, head unit 700 may be mounted on patient P head first, and then straps and interface member 200 may be tucked on patient P head until interface member 200 is approximately in the required position. Finally, the relatively inelastic connecting straps 730 can be stretched to the required length, usually at the time when the gas stream is fed to the interface means.

In some cases, the generally inelastic connecting straps 703 are set to a longer length, which is sufficient to facilitate the mounting of the interface means 200 and the head unit 700 on the patient's head. The interface means 200 is gripped by one hand and the head unit 700 is gripped by the other hand. Head equipment 700 is mounted on the head with one hand. The other hand is tensioning the relatively elastic straps 732 of the head unit 700 while pulling the interface means 200 away from the head unit 700. With the interface means 200 disengaged from the head unit 700, the interface means 200 is pulled downward on the patient's face to accommodate the mouth and nose.

When released, the relatively elastic straps 732 have sufficient holding force to hold the interface means 200 on the patient's face and hold the head unit 700 on the patient's head, while the relatively inelastic connecting straps 730 remain loose. To complete adjustment of head unit 700 and interface means 200, relatively inelastic connecting straps 730 are pulled through adjusting mechanism 736 until a suitable length or voltage of relatively inelastic connecting straps 730 is reached.

Referring to FIG. 28, a further configuration will be described in which the relatively inelastic connecting straps 740 are at least partially integrated with the relatively elastic connecting straps 742. The relatively inelastic connecting strap 740 shown consists of a substantially non-elastic strap attached at one end to the head unit 734. At the other end, the substantially elastic connecting strap 740 is coupled to the interface means 200 via an adjusting mechanism 744 that allows the length of the connecting strap 740 to be varied. In the shown configuration, the elastic connecting straps 742 have a channel 746 extending from one end to the other through which a relatively inelastic connecting strap 740 is fed. The adjusting mechanism 744 may include friction buckles or other suitable adjusting mechanisms, including but not limited to those discussed in this application. Preferably, the adjusting mechanism is mounted on the interface means 200, but may be mounted anywhere as required. FIG. The advantage of the 28 illustrated embodiments is that the configuration is compact, visually unobtrusive and less likely to be tangled by straps.

It is understood that this embodiment may have upper and lower straps or only one level of strap (s) between head unit 734 and interface means 200. FIG. The embodiment shown in Figure 28 applies a relatively inelastic coupling strap 740 to a locking mode by friction buckles 744 or other suitable adjustment mechanism. In free mode, relatively inelastic connecting straps 740 are lengthened or shortened. In locking mode, the length of the straps 740 is fixed or can be extended. When mounting the interface means 200, the connecting straps 740 and the respective adjusting mechanisms 744 provide a limiting effect which reduces the likelihood of increasing the distance between the interface means 200 and the head unit 734, while the more elastic connecting straps provide temporary holding force 742 during initial installation.

As in previous embodiments, FIG. 28, the interface device or head unit may first be mounted. In the preferred installation procedure, the interface device and head unit are mounted substantially simultaneously, as described above, and begins with the addition of the interface device to the patient's face for immediate treatment.

In some configurations, the relatively inelastic connecting member 740 may be replaced or may be supplemented as shown in FIG. 29, a substantially non-compressible or non-foldable ridge member 748 extending through channel 746. In this embodiment, the ridge member 748 provides a connection between interface means 200 and head unit 734, which is generally resistant to both elongation and compression or bending. In such a configuration, it is desirable that the ridge member 748 is semi-rigid enough to resist bending and crushing forces, allowing the head unit to maintain a common shape.

It has been found that, especially for semi-rigid head equipment, a supportive form or stand-alone form is common to a whole set that is intuitively applied. In particular, where the coupling and / or head unit is self-contained, for example, it retains a three-dimensional shape, the head unit may be correctly installed without instruction or with very little instruction. In a rigid form, the tendency of the straps to become tangled also reduces the installation time of all equipment.

The semi-rigid nature of the ridge 748 makes it possible to shorten the length of the connection between interface means 200 and head unit 734 in a simple manner. For example, when the ridge 748 is used in place of a cord or cord, the length of the linkage by the adjusting mechanism 744 when in position may tend to "automatically shorten" according to the holding force of the elastic linkage strap 742. This feature also helps to simplify the 'put-in and / or remove' procedures used in the system.

Semi-rigid head equipment

Embodiments of the head unit used with the Patient Interface Utility 200 in accordance with FIG. 30-32. In the shown configurations, head unit 700 comprises a semi-rigid set of head unit 800. It has been found that FIG. The advantage of the head unit shown in Fig. 30 is that the head unit can maintain a substantially three-dimensional shape when not in use. As a result, the placement of the head unit on the patient's head is intuitive and can be performed consistently and accurately with little instruction, and may preclude confusing straps.

The term "semi-rigid" used in this document is used to indicate that the head equipment is sufficiently rigid to allow the assembled head equipment to have a three-dimensional shape similar to the patient's head for which the equipment is designed and flexible enough to fit the patient's body. . For example, some other components of the head unit (such as straps) may also be partially or completely "semi-rigid" to the extent that all components are capable of retaining a three-dimensional shape that is essentially "self-contained or rigid". "Semi-rigid" head equipment does not imply that each component of the head equipment is semi-rigid. For example, a substantially three-dimensional shape primarily concerns the backs and tops of a self-contained head unit. Additionally, "semi-rigid" head equipment may have semi-flexible areas that extend toward and above the ears when applied to the patient's head.

The head unit 800 shown generally has a first strap portion 802 adapted to include the patient's head. The illustrated first strap portion 802 typically comprises three components or areas: the lower posterior region 804, the side region 806, and the upper region 812. In some configurations, at least the first region 802 of the strap may have contrasting colors on the inner and outer surfaces such that easy to set surface.

The lower posterior region 804 is adapted to include the posterior portion of the user's head.

Preferably, the lower posterior region 804 is adapted to accommodate the head at or below the occiput. The lower posterior region 804 covers the distance from the occiput to the sides of the head. In some configurations, the lower posterior region 804 has a longitudinal center disposed approximately 25 degrees below the horizontal plane extending through the patient's ear canal.

On either side of the head, the first strap portion 802 extends upward to the left and right side regions 806. The lateral regions 806 generally extend upward and outward. Lateral areas 806 extend beyond the patient's ears. Preferably, the lateral areas 806 also extend beyond the patient's incisor bone. Each of the 802 left and right sides of the first strap portion

806 extends or forms an arch portion 808. The arch portion 808 flexes up and back. The arch portion 808 extends over the respective ear of the patient. Preferably, each arch portion 808 terminates at a respective cut-off portion 810. Preferably, the cut-off portions 810 are positioned in front of the patient's ears. In some configurations, the side areas 806 and the arch portion 808 of the first strap portion 802 do not have a soft inner mat portion but may have a single, non-rigid, elastic material that directly contacts the patient's head or hair.

The upper portion 812 of the first strap portion 802 connects the arch portion 808 of the lateral portions 806. In some configurations, the upper portion 812 may be disposed in front of the ears. Preferably, the upper portion 812 is positioned vertically from the ears. More preferably, the longitudinal center of the upper portion 812 is disposed about 13 mm back from the vertical plane that intersects the ear canal. In some configurations, the upper portion 812 comprises a first segment 814 and a second segment 816, the first segment 814 and the second segment 816 forming a top portion 812. The first segment 814 extends upward from the vertex of the left arch portion 808, and the second segment 816 extends upward from the right arch portion. 808 vertices. Preferably, the upper portion 812 is formed of a non-rigid and elastic material. In some configurations, the top portion 812 has no backing, including a layer of soft mat.

The first segment 814 and the second segment 816 may be connected by any suitable connection 818. The connection 818 may have an adjusting mechanism such that the first and second segments 814, 816 are adjustably connected. It is desirable that the underside of the adjusting mechanism of the connector 818 is substantially flat for improved comfort. Preferably, the size of the adjusting mechanism may be adjustable to a variety of sizes. For example, connector 818 may have a plurality of spaced openings in the first segment 814 and one or more upwardly projecting projections disposed on the second segment 816. In some configurations, the openings and projections form an adjustment pitch of about 20 mm at one, two, three, or more possible positions. This type of adjusting mechanism allows the upper part 812 to be easily adjusted by sliding the projection through the corresponding opening.

Although, in some cases, the first and second segments 814, 816 are integrally formed (i.e., the top portion 812 is a single strap which is permanently or semi-permanently attached to the arch portion 808) and in some cases the first and second segments 814, 816 are connected unregulated, the configuration shown allows adjustment to accommodate head equipment for 800 patients.

Further with respect to FIG. 30, it is desirable that at least the portions 808 of the arch be sufficiently rigid to withstand significant deformation or displacement. In other words, the arch portions are rigid enough to withstand the deformation of the arch when the load is applied to the boundary portions 810 or near and facing forward. For example, but without limitation, the applied load may correspond to the tensile force that the interface means 200 may exert when applied to the breathing gas supply and the patient wearing the head unit 800. Preferably, the limiting member 810 is configured strong enough to support the load bending characteristics corresponding to the following equation: [(t * w³) / 12j * TS> 2400 where t is the thickness of the material, w is the width of the strap and TS is the tensile strength of the material of the strap. Preferably, at least the remainder of the first strap 802 of the head unit 800 (e.g., the arch portions 808, the lateral areas 806, the upper portion 812, and the lower rear region 804) are configured to satisfy the following two equations: (1) [(w * t³) / 3] * FM <6,250, where t is the thickness of the material, w is the width of the strap and FM is the modulus of elasticity of the material used for the strap; and (2) [{w * t³) / l2] * TS <24, where t is the thickness of the material, w is the width of the strap and TS is the tensile strength of the material used for the strap. In addition, the width of the strap should preferably be at least 25 mm. In some configurations, the strap width is approximately 30 mm. In some configurations, the strap thickness is approximately 1 mm.

Again with reference to FIG. 30, the left lower strap 820 and the right lower strap 822 extend from the lower rear region 804 on the respective side. Preferably, the left lower strap 820 and the right lower strap 822 extend from the lower posterior region 804. More preferably, both the left and right lower straps 820, 822 extend forward below the patient's ear.

The left and right lower straps 820, 822 may be made of semi-rigid material or may be comprised of corresponding non-rigid materials. As noted herein, semi-solids may be formed from plastic or sheet materials, which include, but are not limited to, homogeneous plastic materials and nonwoven adhesive materials. Where the lower straps 820, 822 are semi-rigid, it is desirable that they are integrally formed with at least the lower rear region 804. However, in some configurations, the lower straps 820, 822 may be formed individually and may be attached to the lower rear region 804 in a continuous, semi-permanent manner. or removable. Preferably, the left and right lower straps 820, 822 are formed as an integral component, which in use extends from behind to the patient's head and / or neck. The integral component may be integrally formed with the lower posterior region 804 or may be formed separately from the lower posterior region 804 and affixed to the lower posterior region by any suitable means. Shaping the left and right lower straps 820, 822 into a solid member reduces the likelihood that one of the straps 820, 822 detached from the lower posterior region 804 will release the interface device 200 from the patient's face in the event of failure as the integrated straps 820, 822 will remain fastened around the patient's neck or head even if straps are integrated

820, 822 will be separated from the lower posterior region 804.

The left upper strap 824 and the right upper strap 826 extend respectively from the respective boundary portions 810. It is desirable that the upper straps 824, 826 extend forward and around half of the patient's head. Even better, the upper straps 824, 826 are adapted to extend into the area below the patient's eye. The top straps 824, 826 are connected to the interface means 200.

In some configurations, the top straps 824, 826 are formed separately from the first strap portion 802. The top straps 824, 826 may be made of a semi-rigid material or a comfortable and / or adaptable material. In some embodiments, the upper straps 824, 826 may comprise a soft mat (i.e., laid on a patient's face facing surface) comprising a laminate structure and generally an inelastic portion (i.e., opposite to the mat, with respect to the patient's head). Such a configuration is shown in FIG. 30th Any lower straps 820, 822 or upper straps 824, 826 may be of such a laminate structure that the strap portion has a soft mat element at least on the inner portion of the strap that contacts the patient's head or face. Preferably, at least the lower straps 820, 822 and, in some configurations, the upper straps 824, 826 are also configured to withstand a maximum load of approximately 15 N from each strap hole. Although the straps can be configured to carry a higher load, the straps that hold a maximum load of about 15 N are small straps and strong enough to counteract the forces exerted by the mask. Thus, it is desirable that the straps be sized to counteract the forces exerted by the pressure on the interface means 200.

As used herein, the term "soft" refers to the quality of the material when touched with respect to head equipment and straps. In addition, the term "adaptive" in relation to head equipment and straps is used to describe the ability of a material to conform to the patient's anatomical features (e.g., facial features). In particular, the strap comprising at least the element "soft" and / or "adaptive" may also be "semi-rigid" and / or inelastic in the axial direction.

Attachment of the top straps 824, 826 to the respective boundary members 810 may be accomplished in any suitable manner. In some configurations, the attachment is effected by a joint that allows the upper straps 824, 826 to pivot about a pivot point 828, such as shown in FIG. 31. Turning point 828 may be disposed on boundary portion 810 at a point of intersection with a plane inclined approximately 33 degrees from the vertical axis. In some configurations, the plane is approximately 33 degrees ahead of the plane defined by the top portion 812. However, in some configurations, the top straps 824, 826 may otherwise be connected to the first strap portion 802. In some configurations, the top straps 824, 826 may be integrally formed with the first strap. part 808 arch parts 802.

Referring to FIG. 34, the joint between the lower straps 820, 822 and the lower rear portion 804 may be integrated, e.g. 30. As shown in FIG. 34, the straps and the lower portion may be configured with a flexible region 836 to provide a degree of bending along its width (see arrow 850 illustrating movement in a paper plane) and a degree of rotation along an axis (see arrow 852). These movements help the straps 820, 822 to conform to the patient's body while slightly increasing the bending in the thickness direction compared to the structure without the flexible area 836. As shown in FIG. 34, the flexible region may have a ribbed region having a portion formed during material removal. This flexible region 836 has a vertebra appearance and can flex and rotate to improve the adaptation of the straps 820, 822 to the patient's body while being reinforced with the first strap portion 802. In addition, straps 820, 822 may reduce the likelihood that the reinforcement will starve the patient or cause the patient to feel a hard edge. Reinforcement may be attached to straps 820, 822 by any suitable means including, but not limited to, multilayer casting, welding, bonding, bonding, bonding, or the like.

In some configurations, such as the one shown in FIG. 30, the first strap portion 802 described above may be comprised of a single planar member that acquires a three-dimensional shape of the head unit when the first and second segments 814, 816 of the top portion 812 are joined together. In some configurations, the first strap portion 802 and the lower straps 820, 822 consist of a single flat member. In some configurations, the first strap portion 802, the lower straps 820, 822, and the upper straps 824, 826 are all formed from a single flat member. In some configurations, the first strap portion 802 and the upper straps 824, 826 are all formed from a single flat member. In some configurations, the first strap portion 802 is formed from the first common flat element, and the first and second lower straps 820, 822 are formed from the second common flat element. The first and second flat members may be secured together in any suitable manner. In addition, in some cases, one or more head unit parts (e.g., the first strap part 802) may be molded or otherwise shaped as a three-dimensional member.

The flat members may be made of a rigid, resilient, substantially inelastic material, such as, but not limited to, santoprene, polyolefin, polypropylene, polyethylene, polyolefin foam, or nonwoven polymeric material. In some configurations, the flat elements are formed of a polyethylene or polypropylene family. The material may be low density polyethylene, such as Dowlex 2517 which is a low linear density polyethylene with a tensile strength of 9.65 MPa, a tensile strength of 8.96 MPa, and a modulus of elongation at bending of 234 MPa at 2% .

Preferably, the planar member is formed of a material such that the head unit 800 is substantially shaped to support its own weight, regardless of the orientation of the head unit 800. In some configurations, the straps should not be stretched more than about 6 mm at a tensile load of 30 N. In some configurations, the straps are not stretched more than about 3 mm under a tensile load of 30 N.

In some configurations, one or more straps or flat members may be formed of a nonwoven polyolefin bonded to a polyolefin (e.g., multilayer molding or laminating). In such configurations, the polyolefin material formed by the multilayer molding provides principally shape retention properties. In addition, the softer non-woven polyolefin material is designed for skin contact and the desired level of comfort. In addition, the nonwoven polyolefin material can provide the required load-bearing properties, such as the required tensile load-bearing properties. In some configurations, the lower straps 820, 822 may comprise a soft material, such as, but not limited to, a nonwoven polymer.

The embodiments of the head unit 800 described above are low profile and the head unit itself is comfortable, very little or substantially non-conforming. For example, head equipment may have a modulus of elasticity greater than 10 kPa. Even better, the head unit may have a modulus of elasticity greater than about 20 kPa. By using at least semi-rigid materials for the first portion of the strap 802 (i.e., the parts that engage the lower and upper parts of the head), the head unit is capable of independently maintaining the three-dimensional shape. This attribute, together with the features described in this application, provides head equipment that is intuitively applied without instruction or with little instruction. In particular, installation speed was found to be significantly more important than the design of existing head equipment.

With particular reference to FIG. 30, the lower straps 820, 822 and the upper straps 824, 826 have a plurality of adjusting apertures 830 to form an adjusting mechanism for mounting the head unit 800 on a plurality of configuration interface means 200. Preferably, the interface means 200 has protrusions 832 adapted to engage in straps 820, 822, 824, 826. When making apertures, it is desirable to use a laser cutter that burns the material around the apertures so that the aperture durability can be greatly enhanced compared to a simple manufacturing method. The illustrated mounting style and adjusting mechanism are effective in practice and provide an intuitive solution with little or no training required. A particularly useful location for the adjustment or connection means 200 is the surface of the interface means. Preferably, the location of the adjusting or engaging means 200 is disposed on a laterally extending portion of the support member 204 formed on the outer surface of the engaging means 200. This provides easy access and facilitates installation or adjustment when, for example, the patient's head is resting on a pillow. In other words, the strap adjustment can take place in front of the ears, and better yet, at the front of the outermost posterior surface of the interface means. This adjustment also allows the strap length balance to be corrected from left to right due to the finite number of positions defined by the openings 830. The openings 830 in the upper and / or lower straps (820, 822, 824, 826) can be easily counted or visualized symmetrically install head equipment. Further, since there is no tensioning of the strap, such as can be found using a notch and hook or loop elements, as shown in FIG. 22, the forces that can be applied when fitting the straps 820, 822, 824 826 are considerably lower. In other words, there is no multiplier effect possible with the mounting and adjusting mechanism shown in FIG. 30-32.

In addition, the illustrated straps 820, 822, 824, 826 naturally move forward due to their semi-rigid configuration. In some configurations, only some of the illustrated straps 820, 822,

824, 826 consists of a semi-rigid structure. The part may be horizontal or forward enough to keep the straps hidden or not tangled behind the patient's head. In addition, in some cases, the connecting portion of the lower straps 820, 822 and the lower posterior region 804 are semi-rigid, whereas the distal ends (i.e., the ends of the straps 820, 822 that connect to the interface means 200) are much more flexible, remain relatively inelastic in the axial direction. The natural forward-facing position of the straps 820, 822, 824, 826 allows the openings 830 to be aligned and aligned with the interface projections 832 of the interface means 200 intuitively and easily. When the straps 820, 822, 824, 826 are too long for a particular patient, the straps 820, 822, 824, 826 may protrude well beyond the opening 830 through which the protrusion 832. In this situation, the protruding strap 820, 822, 824 can be doubled, 826 by returning it through an additional opening 830. The result is a neat and clean arrangement where the rest of the strap is held on the interface means.

Preferably, in one embodiment, the connection between the upper straps 824, 826 and the patient interface means 200 is semi-constant. An installation process in such an embodiment will now be described, with particular reference to FIG. 32A-32D. FIG. 32A shows how the healthcare provider holds the interface device 200 and places it on the patient's face for immediate initiation of respiratory therapy. When the interface means 200 is placed on the face, the interface means includes a sealing flange 208 as previously described. Flange 208 has a niche for accommodating and / or positioning the patient's chin. Thus, when interface device 200 is applied to the face, the chin is placed in the niche and then the remaining interface device 200 contacts the face. With the interface device on the face, the health care provider grabs the head unit 800, which is connected to the interface device with the upper straps 824, 826, and raises the head unit 800 over the patient's head. As shown in FIG. 32B, the health care provider pulls head equipment 800 down through the patient's head. The lower straps 820, 822 remain untangled at the sides of the head due to the semi-rigid structure. In addition, the interface means 200 is held loosely on the face by the upper straps 824, 826. As shown in FIG. 32C, the health care professional connects the lower straps 820, 822 to the interface means by sliding the projections 832 through the respective openings 830. If necessary, the upper straps may be adjusted as shown in FIG. 32D. Final adjustment can be made with the upper straps 820, 822 and / or the lower straps 824, 826 to complete the final assembly. It is understood that the above steps need not be carried out in this order.

With particular reference to FIG. 31, the head unit 800 has substantially inelastic upper straps 824, 826 which are attached to the head unit 800 at an axis of rotation at point 828. At the other end, the substantially inelastic connecting straps 824, 826 may be coupled to the adjusting mechanism of the interface means 200. lengths of straps 824, 826. For example, the length of the connection between interface means 200 and head unit 800 may be adjusted by sliding projection 832 of interface means 200 through respective opening 830 in each of straps 824, 826. Each of the left and right side top straps 824, 826 may have a resilient elastic strap 834. , which is attached to the head unit 800 at one end and to the interface device at the other end by any suitable means. Preferably, when parallel straps are used (i.e., parallel elastic and inelastic straps), the two straps should be colored differently to contrast between elastic and elastic straps. The parallel arrangement of the elastic and inelastic straps 824, 826, 834 facilitates a two-stage mounting process similar to that described above. Initial assembly may be performed with elastic straps 834, prior to final assembly using non-elastic straps 824, 826. In some configurations, lower straps 820, 822 may be fabricated in the same manner as just described.

Head equipment

FIG. 33 shows another head unit 900. The head unit 900 can be used in conjunction with various patient interface devices as described previously. The illustrated head unit 900 is particularly suited to the Patient Interface Tool 200 of the configuration described above. The head unit 900 is designed to be easily mounted and removed by people with low ability. In addition, the illustrated head unit 900 is extremely easy and convenient to attach and remove, as there are no straps in front of or behind the patient's ears. In head equipment that has straps extending beneath the patient's ears, these straps can be clamped onto the patient's ear when removed or mounted.

The illustrated head unit 900 has an upper strap 902 extending through the top of the patient's head. Ideally, the upper strap 902 lies substantially flat and curved about the patient's head. Preferably, the upper strap 902 is positioned over the patient's torso, usually behind the ears.

The upper strap 902 may have a lateral curved portion 904. The lateral curved portion 904 extends from a generally vertically extending upper strap 902. Preferably, the lateral curved portion 904 extends from the upper strap 902 above the ears. The lateral curvature extends forward and down in relation to the ears. Preferably, the lateral curved portion 904 terminates below and in front of the patient's ear.

Head unit 900 further includes a back strap 906. The strap 906 may be pivotally connected at pivot point 908 to the upper strap 902 above the patient's ear. Preferably, the pivot point 908 is located near the joint between the generally vertically extending upper strap 902 and the lateral curved portion 904.

Rotation axis 908 allows the rear straps 906 to rotate between two working positions. In the first operating position shown in FIG. 33A, the rear strap 906 is pivoted upward to disengage from the patient's head, which allows easy removal of the head unit 900. In the second operating position shown in FIG. 33B, the rear strap 906 may be pivoted downwardly so that the lower rear portion of the rear strap 906 engages behind the patient's head in the backside. Preferably, the lower back of the back strap 906 is configured to hug the patient's head at or below the occiput.

The rear strap 906 and the upper strap 902 may have a locking mechanism which can lock the rear strap 906 in the lowest position substantially shown in FIG. 33B. In some configurations, the locking mechanism includes a stopper and a joint protrusion, which may be associated with either the top strap or the rear strap, respectively. Preferably, the stopper and projection reflect a matched set on either side of the head unit 900.

In some configurations, the top strap 902 may be provided with a protrusion and the rear strap 906 may be provided with a joint stop. When the rear strap 906 is lowered to the position shown in FIG. 33B, the stopper is aligned with the protrusion and the rear strap 906 and locked in a position that would allow the rear strap 906 to engage the interface means 200 on the patient's face.

To release the rear strap 906 so that the head unit 900 can be easily removed, the protrusion may be spring-loaded and released by pressing the spring until the protrusion is released from the stop. Alternatively, the rear strap 906 may be raised with sufficient force to overcome but not damage the locking mechanism. The head unit 900 can also be used with other suitable locking mechanisms.

The lateral curved portion 904 of the head unit 900 shown may have anchorage points 916, 918 from which the straps 920, 922 (i.e., the upper and lower straps, respectively) may be connected to the interface means 200. In some configurations, the head unit 900 may include only one a strap between the interface means 200 and the head unit 900 on each side of the lateral curved portion 904. In some configurations, the upper strap 920 may be connected to the lower portion of the interface means 200 and the lower strap 922 may be cross-linked to the upper portion of the interface means 200.

In some configurations, one or more straps 920, 922 may be formed of a resilient elastic material. In some configurations one or more straps

920, 922 may be formed of an almost inelastic material. The upper strap 902 and the lateral curved portion 904 may be formed of a semi-rigid non-rigid material such that the head unit 900 maintains a substantially three-dimensional shape and is generally not confused. In addition, the back strap 906 may be formed from a semi-rigid material that is almost rigid. In some configurations, the material may, for example, include, but is not limited to, a laminate structure in both movable and semi-rigid portions.

At least the upper strap 902 portion and the laterally curved portion 904 may have pads to improve patient comfort. The back strap 906 may also have at least a portion of the mat to further enhance patient comfort. The mat may be of any suitable configuration that provides at least a layer of mat material on the inner parts of the scalp in contact with the patient's skin and / or hair. In some configurations, the mat may have a soft foam layer or other soft material. In some configurations, semi-rigid headpiece components may be fully or partially coated, for example, but not limited to, soft material, or formed by multilayer molding with soft material.

The foregoing description of the invention includes the preferred forms. Modifications are made without departing from the scope of the invention as set out in the appended claims. It is understood that the present invention describes many inventions (masks) for patient interface devices, as well as inventions for head equipment and a control system. While the description provides a number of examples where various embodiments of the interface device are combined with various embodiments of the head unit, each embodiment of the invention is not fully disclosed. It is contemplated that each combination of elements may be used individually or in combination as part of the present invention. In addition, other known head unit and interface device designs may also be used with the interface device and head unit designs of the present invention.

DEFINITION OF INVENTION