Method for manufacturing a patient interface with gel filling as well as patient interface with gel filling

Abstract

Method for manufacturing a gel-filled patient interface, comprising the following steps: In a first step, the production of a closed gel shell (3), wherein a shell blank is closed by a plug and a firm connection between the shell blank and the plug is established by using a bonding agent, wherein the closed shell is made of a uniform material and is intended for placement on an external surface of a patient's body and Subsequently, in a second step, an opening of the closed gel shell (3) is caused by an injection of an injection medium and liquid gel is injected into the gel shell (3) by means of the injection medium.

Description

[0001] The invention relates to a method for producing a gel-filled patient interface, comprising the following steps: In a first step, the production of a closed gel shell (3), wherein a shell blank is closed by a plug and a firm connection between the shell blank and the plug is established by using a connecting agent, wherein the closed shell is made of a uniform material and is intended for placement on an external surface of a patient's body, and subsequently, in a second step, an opening of the closed gel shell (3) is caused by an injection of an injection agent and liquid gel is filled into the gel shell (3) by means of the injection agent.

[0002] The invention further relates to a patient interface with a gel filling manufactured according to the method according to claim 1.

[0003] A gel core for a ventilation mask, as described in EP 0 799 076 B1, is made of a polyurethane (PU) gel enclosed in a protective PU film. An additional silicone sleeve lies between the patient's face and the PU gel core. The wall thicknesses of the PU film and the silicone sleeve are essentially constant. The hardness of the gel core is below Shore 10.

[0004] The material properties and hardness of polyurethanes are not equally suitable for all users. Polyurethanes (PU) are formed through a condensation and adduction reaction between isocyanates and polyols. Numerous additives are used in PU production. In partially cured polyurethanes, monomers such as isocyanates can remain. Exposure to isocyanates and additives can lead to both allergic and irritant contact dermatitis. This causes some patients to reject PU materials.

[0005] US Patent 2007 / 0221227A1 describes a method for manufacturing a patient interface. The patient interface has a gel filling arranged in a cavity within a gel shell made of a flexible material.

[0006] Comparable methods for manufacturing a patient interface as well as a patient interface with gel filling are also described in DE 10 2005 033 649 A1, DE 20 2007 019 573 U1 and EP 1 946 901 A1.

[0007] The present invention aims to improve the wearing comfort of a patient interface and patient compliance, and to enable cost-effective manufacturing.

[0008] The problem is solved by the features of claim 1.

[0009] A further object of the present invention is to design a patient interface of the type mentioned in the introduction in such a way that improved wearing comfort is achieved with cost-effective manufacturing.

[0010] This problem is solved by the features of claim 7.

[0011] The gel filling can have a wide variety of properties, including gel materials such as polyurethane or silicone gel, or the natural gel agarose, as well as foams, gas mixtures, and liquids such as saline solution, which is often used in medicine. Ultimately, it can also be the same material from which the gel shell is made, especially if it is foamed. Thanks to the integrated design according to the invention, the thickness of the gel shell walls can be very precisely adjusted to the requirements, in order to give certain areas of the gel shell more or less rigidity as needed.

[0012] The invention is suitable for any patient interface that rests against the body. The invention can therefore be used in particular with the following types of patient interfaces: nasal, oral, and full-face masks, nasal pillows or nasal prongs, in emergency, home, and hospital ventilation, CPAP, APAP, and bilevel ventilation, as well as with medical orthoses, prostheses, and support devices.

[0013] To manufacture the patient interface according to the invention, it is proposed to produce the gel shell from an elastic plastic, preferably a silicone, with at least one cavity using a molding process, and then to fill this cavity with the intended gel. The filling should preferably be carried out through at least one opening provided for this purpose, which is preferably not located in the areas of the gel shell that come into contact with the skin.

[0014] Filling is most preferably carried out by injecting the filling material, with the shell preferably being pierced in the thicker areas. The at least one opening is tightly sealed after filling, particularly when using liquid or gaseous fillers, for example with a plug, by welding, or by gluing. Gaseous fillers, in particular, can be pressurized, so that the pressure can influence and determine the properties of the gel body.

[0015] An alternative manufacturing process involves first closing a shell blank with a plug and creating a firm connection between the shell blank and the plug by using a bonding agent, wherein the closed shell is made of a uniform material, preferably silicone.

[0016] An alternative manufacturing method results from specifying the geometry of the casing blank in the manufacturing process by at least one metal core, and removing the metal core after the casing blank has been manufactured through an opening in the casing blank, the length of which is less than half the circumference of the casing blank.

[0017] Furthermore, it is proposed to produce a shell blank that is open in the area defining the contact point between the mask body and the patient interface. In the next step, the shell blank can be bonded to the interface of the patient interface. The patient interface can be made of a hard plastic (preferably PC, PP, or PA), silicone, or a hard plastic (preferably PC or PA) with an integrally manufactured silicone edge (2K process). This solution offers economic advantages because only one bonding process is required.

[0018] It is further proposed to produce a shell blank that is open all around. A closed gel body is inserted into this and bonded or vulcanized.

[0019] According to the invention, it is also intended to produce a shell blank with several openings. These openings are then all closed except for one. The gel is poured in through the remaining opening. Finally, a stopper seals the opening.

[0020] The gel-filled shell, in the area forming the contact contour with the patient, is preferably thinner than 5 mm, particularly preferably thinner than 3 mm, and most preferably thinner than 2 mm in cross-section. This makes the gel feel soft to the patient, despite its relatively hard walls. At the same time, the thin walls of the gel-filled shell make it very lightweight.

[0021] Optionally, a second skin is located over the gel-filled shell, positioned between the gel-filled shell and the patient during use. This second skin can be permanently bonded to the gel body (integrally or glued). Alternatively, the second skin can be mounted as a separate component to the gel body or to the patient interface.

[0022] The wall of the gel-filled shell and / or the wall of the second skin preferably has a thickness of approximately 0.5 mm in at least some areas, and alternatively even only 0.3 mm; in some areas the thickness is up to 1 mm.

[0023] The gel body is secured to the patient interface via a frame, for example via a clip mechanism.

[0024] The gel body is alternatively bonded to the patient interface. Preferably, the open gel body is bonded directly to a rigid plastic (PC) component of the patient interface. Alternatively, the patient interface is manufactured using a two-component (2K) technology and incorporates a silicone component in the area of ​​the interface with the gel body. The connection between the gel body and the patient interface is achieved at this point via a direct bond between the two silicone components.

[0025] It should be noted that the scope of the present invention is not limited to the preferred embodiments presented and that further combinations and variants of the present invention can be deduced by an average person skilled in the art from the main and dependent claims without having to depart from the teaching of the present invention.

[0026] Embodiments of the present invention will now be described by means of examples only, with reference to the associated drawings, wherein functionally identical parts are designated by corresponding reference numerals. Fig. Figure 1 shows a perspective view of a patient interface designed as a nasal mask. Fig. Figure 2 shows a perspective view of the gel shell. Fig. Figure 3 shows a version of the gel shell made of Fig. 2 from the bottom Fig. Figure 4 shows one version of the gel shell made of Fig. 2 from the side Fig. 5 to Fig. 8 each show a cross-section through the gel shell, Fig. Figure 9 shows a cross-section through the gel shell and the patient interface in the contact area. Fig. Figure 10 shows a cross-section through the gel shell and the patient interface in the contact area with mechanical locking mechanism. Fig. Figure 11 shows a cross-section through the gel shell and the patient interface with second skin, Fig. Figure 12 shows a cross-section through the gel shell and the patient interface in the contact area with the sealing element. Fig. 13 five options for connectivity, Fig. 14 a schematic representation of a multi-component injection molding process, Fig. 15 a sketch to illustrate a manufacturing process, Fig. 16 an injection molding process using a switching plate, Fig. 17 Another illustration to demonstrate the injection molding process, Fig. 18 a perspective view and two sectional views of a nasal pillow, Fig. 19 a side view and a longitudinal section through a nasal pillow, Fig. 20 an embodiment of a nasal pillow made of Fig. 19 Fig. 21 an embodiment of a two-part nasal pillow, Fig. 22 a nasal pillow with two membrane openings and Fig. 23 a variation of Fig. 23.

[0027] Fig. Figure 1 shows a patient interface designed as a nasal mask, the mask body (1) of which is made of a relatively rigid material and has a gel-filled shell (3). This shell (3) serves to seal against the face of a patient (not shown) and ensures the necessary seal. The mask body (1) is connected via an angled connector (2) to a rotatably mounted sleeve (4), which serves to connect to a breathing gas hose (not shown). To ensure secure positioning of the breathing mask in the patient's head area, a forehead rest (5) is used, which is inserted into a holder (36) of the mask body (1) via a shaft (35). The connector (2) and the mask body (1) are connected to each other via a ball joint (18). The ball joint (18) is supported by a retaining ring (31).A forehead pad (13) is slidably attached to a bracket (12) of the forehead support, providing additional support for the mask on the patient's forehead. The mask is secured to the patient's head with straps (not shown).

[0028] The gel shell (3) terminates on its contact side intended for contact with the patient's facial area in a tapered contact lip (7), which provides a soft and flexible contact zone around the perimeter of the gel shell (3). The walls of the gel shell (3) are closed off with a patient-interface-side connecting body (6), which is either made of the same material as the gel shell (3) or is designed as a separate part to be attached by adhesive or welding.

[0029] The connecting body (6) is mechanically connected to a mask base (not shown) by means of snap-in parts, or alternatively, it can be permanently connected to the mask base by adhesive or welding. The cavity (9) is bounded by an outer skin (8).

[0030] According to the invention, the thickness or depth of the filler (15) can also be essentially constant along the cross-section of the gel shell (3).

[0031] To fill the cavity (9) with a filler (15), the gel shell (3) has at least one opening which is located in Fig. 1 is not shown. This opening can be positioned anywhere in the wall of the gel shell (3), except in the area of ​​the outer surfaces of the contact lips (7) and their surroundings, so that it does not interfere with the facial skin to be contacted. The filling opening is preferably glued, welded, or closed with a plug.

[0032] For example, a soft buffer zone is created by using a thin filling material for the cavity (9). Filling the cavity (9) with a relatively inflexible material, such as a gel with a hardness greater than 15 Shore 00, gives the buffer zone (16) a supporting function. The resilient buffer zone (16) can also be designed such that the filling exhibits at least two different elastic properties in certain areas.

[0033] Fig. Figure 2 shows a three-dimensional representation of a gel shell (3) which has contact lips (7) that are shaped to enclose the edge and project inwards into the gel shell (3). The wall (6) of the gel shell (3) serves to connect to the mask body (not shown) by means of mechanically snapping elements, and it contains at least one cavity (9) with a filler (26) therein, which are not shown in the figure.

[0034] Fig. 3 and Fig. Figure 4 shows further perspective views of the mask part according to Fig. 2. In Fig. Three openings (10) are visible in the area of ​​the lower part of the mask. The gel is filled into the cavity (9) through these openings. In one embodiment, the openings (10) are designed as recesses in the outer skin (8), which are closed with plugs (11) after filling. In another embodiment, the openings (10) are designed as thickened areas of the outer skin (8) that are pierced with an injection cannula to fill the cavity (9) and which close themselves after the cannula is withdrawn due to the elasticity of the material. Ribs (14) are formed in the connecting body (6) that serve for coding and determine the orientation. In addition, the ribs allow a pneumatic passage from the inside of the mask to the pressure measuring ports of the mask body (not shown).

[0035] Fig. Figure 4 illustrates in particular the use of plugs (11) which are inserted into the openings (10) of the gel shell (3) after the gel has been poured into the associated cavity. The manufacturing principle will be explained in more detail later. The openings (10) are preferably formed in the area of ​​the connecting body (6) because the material thickness is greater there. A greater material thickness of the outer skin (8) is preferred for both injection and for bonding the opening (10) to a plug (11). The material thickness of the outer skin (8) in the area of ​​the opening (10) is preferably greater than 1 mm in cross-section and particularly preferably greater than 2 mm in cross-section. The opening (10) in the upper right part of the image is formed as part of the connecting body (6). Accordingly, the associated plug (11) has the profile of the connecting body (6).In the cross-section of the plug (11) a circumferential undercut can be seen, which accommodates a corresponding groove in the mask body. The connecting body (6) has a slightly raised and beveled insertion aid (17) that facilitates the easy assembly of the gel bead onto the mask body.

[0036] The Fig. Figures 5 to 8 show cross-sections through cavities filled with filler material (15). Fig. 5. The openings (10) are closed with plugs (11) and the cavity (9) is filled with gas. It can be seen that the material thickness in the area of ​​the connecting body (6) is at least twice as thick in some sections as the material thickness in the area of ​​the outer skin (8). In the Fig. 6 and Fig. 8 the cavity is homogeneously filled with a filler (15). Fig. Figure 7 shows the openings (10) without plugs and the cavities (9) without filling. Fig. Figure 8 also shows that the cavity filled with filler (15) can have different shapes. Furthermore, the cavity filled with filler (15) has a thinnest point (19) in the patient contact area in cross-section.

[0037] The filler (15) according to the invention makes it possible, within a very large design range, to provide the gel shell (3) with a predictable increased stability precisely in those areas where this is required, and to leave other areas of the gel shell (3) with a thin wall thickness and / or a very soft material consistency.

[0038] The filling opening described above can be designed as a classical opening that is closed again after the filler (15) has been applied. However, the primary intention is to introduce the filler (15) in a flowable consistency by injection into the cavity (9). If this injection takes place in a thick-walled area within a casing of the cavity (8) (11), the injection channel closes automatically after the injection material is withdrawn due to the elastic material properties. This significantly simplifies manufacturing.

[0039] In a further embodiment, the material thickness of the walls (8, 11) of the gel shell (3) can be selected differently, thereby ensuring on the one hand the necessary stiffness and on the other hand a contact with the skin that is as soft and tightly sealing as possible.

[0040] In particular, in the area of ​​the walls of the gel shell (3) that are in contact with the face, the wall has a lower material thickness than the areas of the walls of the gel shell (3) that are not in contact with any facial parts (6).

[0041] Preferably, the material thickness of the gel shell walls (3) that rest against the bridge of the nose is reduced. Particularly preferably, the material thickness of the wall in the area resting against the bridge of the nose is reduced compared to areas of the gel shell wall (3) that rest against other parts of the face. This ensures optimal sealing with minimal pressure on the sensitive bridge of the nose.

[0042] Fig. Figure 9 illustrates connections between the gel body (26) and a connecting body of the patient interface. The connecting body can be made of polycarbonate. The connection point can be achieved by a positive fit, as shown on the left of the drawing; according to the embodiment shown in the right-hand drawing, an adhesive bond, also using silicone, can be achieved.

[0043] Fig. 10 and Fig. Figure 11 shows an embodiment of the gel shell (3) according to the invention. The gel shell (3) is connected to the patient interface (mask body) via a mask connection area by means of snap-in mechanical elements. The mechanical snap element is formed here as part of the outer skin (8) of the gel body, for example using a two-component process, and it encloses an undercut of the patient interface with a snap-in lug. A sealing contour (not shown) is located in the area of ​​the connection point (27) between the gel body (26) and the patient interface.

[0044] In Fig. Figure 11 shows that the outer skin (8) is bonded to the gel body. Preferably, the outer skin is designed as a thin silicone lip that covers the contact area of ​​the gel body with the skin. The bond (20) is located in the area of ​​the connecting body (6). Additionally, a locking mechanism (21) can be implemented in the area of ​​the connecting body (6) that detachably connects the gel body (26) to the patient interface body.

[0045] Fig. Figure 12 illustrates a section through the connection point (27) between the gel body (26) and the connecting body of the patient interface (23). The connecting body of the patient interface (23) can be made of polycarbonate (PC) or polyamide (PA) and is preferably rigid. The connection is made via a snap-fit ​​connection, which can be implemented circumferentially or only segmentally. Preferably, for nasal and full-face masks, a segmental snap-fit ​​connection is used in the area of ​​the corners of the triangular mask body. A recess (29) in the area of ​​the connecting body of the patient interface (23) serves to receive the corresponding snap hook (30). The snap hook frame (31) is injection-molded or bonded (silicone / PU) as a rigid part circumferentially or segmentally to the mask bead (3, 7, 8, 24, 25, 32). A sealing element is located in the connection point (27), which has at least one sealing contour (33).The sealing element is located around the entire length of the connection point (27) and preferably acts as a radial seal.

[0046] Fig. Figure 13 shows five possible connection methods. The three variants shown in the drawing above depict positive-locking connections between the silicone and the mask bead. The fourth embodiment shows an adhesive bond without positive locking. Here, the adhesive gap is at least partially filled with adhesive. The fifth embodiment is again a positive-locking connection. Even with the positive-locking connections, additional adhesive bonding is conceivable to further increase the strength of the connection. The strength can be increased even further if the frame element and the gel bead are also bonded.

[0047] The gel bead and the gel are applied according to Fig. 14 is produced in a tool (34) on a machine (40). First, the outer skin (8, A) (e.g., silicone or TPE) is injected and adheres to the outside of the mold. The gel (B) is then injected in the same or a second injection unit (41) and fills the entire interior. It is also intended that the gel is only produced from its at least two components at the time of injection. For this purpose, at least one component is stored in a reservoir (42). This component is only added during or shortly before the injection of the gel fraction (B). If necessary, the injection point is then sealed again with the first component (A). This is injected by the first or a third unit.

[0048] The production of the gel pads according to Fig. 14 can be done with an injection unit. For this purpose, the injection unit is filled with the first and second components, and then the first component again, in one shot (monosandwich).

[0049] It is also conceivable to inject a harder material as a third or further component in order to realize one or more functional elements of the gel bead.

[0050] The production of the gel pads according to Fig. Step 15 can be performed using an injection unit (41). Here, the shell blank is transported from a first mold (43) to a second mold (44). The gel substance is then injected into the second mold. Part or all of the tool, along with the article produced up to that point, is transferred from one machine to the other. It is also possible to transfer only the article between the machines.

[0051] The filling can be done according to Fig. 16 but also with two, three or more units on one machine (40). The units are controlled by the machine and, if necessary, by an additional switching plate (45). The switching plate switches from one component (A) to the next (B).

[0052] It is also conceivable that for manufacturing according to Fig. 17 A machine (40) with an integrated switching plate (45) is used. In this process, the supply from the various units (41) is controlled in the machine.

[0053] The injection process can be optimized by building up pressure between the first and second components using an auxiliary medium. For this purpose, more material than required is introduced into the mold from the first component. In an intermediate step, the excess material is then forced out of the mold using the auxiliary medium. Both gases and liquids are suitable as auxiliary media.

[0054] The gel bead is produced virtually in a single operation, using the so-called monosandwich process. In the monosandwich process, two melts are initially layered sequentially in a common screw cylinder, with the second melt being plasticized via a secondary extruder into the screw cylinder of the main unit. The injection process then takes place with a single stroke, as in conventional injection molding. The sandwich structures are created by the flow characteristics of the axially layered melts in the screw cylinder.

[0055] The first injected material forms a skin against the tool wall, the subsequent material forms the core layer; thus, with regard to the gel bead, first the silicone outer skin (outer skin) and then the silicone gel (core layer) would be formed.

[0056] The pre-made gel bead is mounted manually or mechanically to the frame geometry (2K frame with bladder and coupling for the central element), the connection point is glued and / or vulcanized.

[0057] The plan is to form a silicone protrusion between 3.0 and 15.0 mm long over the frame (on the patient side), which fits as a female or male connecting unit to the male or female counterpart of the gel mask bead.

[0058] Before, during or after attaching the gel mask bead, this connection is filled either with a silicone adhesive or with LSR (Liquid Silicone Rubber). The silicone adhesive is cured under room conditions, while the LSR bond would be vulcanized under pressure and temperature using an additional pressing tool.

[0059] The nasal pillow mask is a special type of patient interface used to deliver gas to the patient's nose. As described in... Fig. As shown in Figure 18, the pillows are made of a soft material such as silicone, which adapts to the shape of the nose, thus creating a good seal and preventing leaks. The pillows are oval or kidney-shaped. Both nasal pillows form a single unit. They can seal directly at the edge of the nose or be inserted slightly into the nostrils. Gel pads (26) embedded in the nasal pillows (25) can also prevent any pressure points that may occur. Small accordion folds (36) in the attachment area of ​​the nasal pillows facilitate better positioning of the nasal pillows (25) on the patient's nose.

[0060] The nasal pillows (25) are attached to the base body (22) via a receiving area made of a harder material. This receiving area can be bonded to the nasal pillows using a two-component process and is held onto the base body (22) by a snap-fit ​​connection. Another variant involves a direct attachment of the soft nasal pillows (25) to the base body (22). In this case, the nasal pillow (25) is slipped over the base body and held in the receiving area (24) of the base body (22). This receiving area (24) can be so pronounced that it forms the counter-bearing of the ball joint (10).

[0061] In another embodiment, the ball of the ball joint connection (10) can be inserted from the outside into the receiving area (23) of the base body (22) with slight force. For this purpose, the ball or the ball receptacle is made of a stable plastic material which deforms slightly under the pressure of inserting the ball, but then returns to its original shape and holds the ball securely.

[0062] Fig. Figure 19 shows a side view and a longitudinal section through a nasal pillow. To define the cavity (9) for receiving the gel filling, the component of the left-extending extension (45) of the nasal pillow (38) is manufactured, and after demolding, this extension (45) is folded inwards. This defines the inner surface of the cavity and shields the gel filling from the interior. The folded extension (45) can be bonded to the rest of the wall material. A fold (46) is provided in the area of ​​the extension (45), which is formed here as a notch. This facilitates the folding process and indicates the length of the extension (45) to be folded. In the folded state, the extension reaches the stop (47).

[0063] Fig. Figure 20 shows a side view and a longitudinal section through a nasal pillow with the extension folded over. The cavity (9) for receiving the gel filling is bounded on the gas-conducting inner side by the extension (45) and on the outer side by the outer skin (8). The extension (45) was folded over to the stop (47) and glued in place. It can be seen that the wall thickness of the outer skin (8) is less in the area of ​​the nasal pillow cushion (38) that receives the gel filling than in the area below the stop (47). This reduced wall thickness supports the pressure-relieving and sealing function of the gel filling.

[0064] Fig. Figure 21 shows a side view and a longitudinal section through a nasal pillow consisting of two parts. The nasal pillow base (25) and the nasal pillow cushion (38) are manufactured separately, and the nasal pillow cushion (38) is filled with gel before being joined to the base (25) and then bonded to the base.

[0065] All geometries are of course also conceivable / feasible in a mirror-image arrangement (for example, a groove in the silicone attachment of the frame and a plug in the gel mask bead).

[0066] It is possible that the geometry is such that, for example, the female side is pre-shaped so that it only deforms into its final position when mounted on the opposite side (male part); this effect would promote a secure hold and flawless bonding.

[0067] Gel fillings are embedded by filling specific areas of the nasal pillow. This improves comfort and firmness. The material of the nasal pillows is typically silicone. The embedded gel is a silicone gel with a hardness of less than 20 Shore 00, preferably between 10 and 20 Shore 00, and most preferably 15 Shore 00. Surprisingly, it has been found that a gel with a Shore hardness of 15 Shore 00 is particularly suitable for providing a comfortable, supportive, and airtight seal at the contact point with the lower nostril, ensuring an airtight seal for the patient interface even under increased ventilation pressure.

[0068] The filling process can be carried out in several ways. In one variant, the nasal pillows can be made in one piece, and the gel filling (26) can be injected through a membrane (39) in the cover, which is located on the side of the nasal pillow facing away from the patient. Each nasal pillow has two membrane openings (39) that serve for filling and simultaneous venting during filling. This is illustrated in the Fig. 22. In another variant ( Fig. 23) the Nasal Pillow base body (25) and the two Nasal Pillow cushions (38) are manufactured separately and the Nasal Pillow cushions (38) are filled with the gel (26) before being connected to the base body (25) and then joined to the base body by gluing.

[0069] The nasal pillow cushions (38) and the nasal pillow base (25) feature an anti-rotation device in the form of a tongue-and-groove connection to prevent incorrect assembly of the nasal pillows. The shape and thickness of the gel-filled pockets can be varied. Preferably, the gel filling is located in a region of the nasal pillows that rests against the underside of the nostril and extends at least partially into the area of ​​the nasal pillows that are inserted into the nose. Furthermore, in the area of ​​the gel fillings, the silicone shell is 10%–50% thinner than the rest of the wall, preferably 20%–40% thinner, to ensure a better fit to the patient.

[0070] Further design variations with support on the bridge of the nose or laterally on the nose allow the patient an unobstructed field of vision. The nasal support can be provided either by small, commercially available spectacle nose pads or by a larger gel pad attached to the nasal support, which is particularly suitable for patients with very sensitive eyesight. The nasal bridge support is click-in to the guide element of the forehead support, ensuring optimal adjustment. The design variations from Fig. 22 and Fig. 23 can be designed as a nose support without forehead support, as well as a nose support with forehead support.

[0071] Due to variations in the silicone Shore hardness, the attachment area of ​​the gel variant, specifically the 2K blister and the actual connection point, could be harder than in the standard silicone variant which is completely injected in one piece. This would be imperceptible / hardly noticeable (not bothersome) in comparison to silicone and would be helpful during assembly.

[0072] It is also conceivable to manufacture the gel forehead cushion cover using a type of gas injection technique; that is, the forehead plate is placed in a manufacturing tool, silicone is injected through a bore inside the forehead plate (plastic plate that serves as a locking element of the forehead cushion) in such a way that it only adheres to the outer shell of the forehead cushion bell (material forms a skin on the inside of the tool wall) (wall thicknesses between 0.5 mm - 1.0 mm), this technique enables the production of the cover without a tool core (steel core that forms the inner area of ​​the cover in the conventional tool).

Claims

Method for producing a gel-filled patient interface, comprising the following steps: In a first step, the production of a closed gel shell (3), wherein a shell blank is closed by a plug and a firm connection between the shell blank and the plug is established by using a bonding agent, wherein the closed shell is made of a uniform material and is intended for placement on an external surface of a patient's body, and subsequently, in a second step, an opening of the closed gel shell (3) is caused by an injection of an injection agent and liquid gel is injected into the gel shell (3) by the injection agent. The method according to claim 1, characterized in that the uniform material is silicone. The method according to claim 1, characterized in that the bonding agent is liquid silicone. The method according to claim 1 is characterized in that the connecting element is activated by the application of energy. Method according to one of the preceding claims characterized in that the gel filling has a cross-section of less than 5 mm. Method according to one of the preceding claims characterized in that the gel shell has a wall thickness of about 0.5 mm and preferably of less than 0.3 mm. Patient interface with a gel filling manufactured according to the method of claim 1, characterized in that a gel shell (3) formed from a flexible material defines at least a cavity (9) in a certain area, wherein the gel shell (3) has a closed opening (10) through which the gel was filled into the cavity (9) in liquid form.

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