Patient interface

Abstract

This invention relates to a patient interface. A patient interface includes a first body resting on a first portion of a patient's face, a second body resting on a second portion of the patient's face, and a bridging portion connecting the first and second bodies. The patient interface includes an attachment structure coupled to a complementary fixation structure positioned on the patient's face to secure the patient interface to the patient's face. The complementary fixation structure can be configured to assist in securing a feeding tube relative to the patient's face or relative to the patient interface.

Description

[0001] Divisional Application Instructions

[0002] This application is a divisional application of Chinese invention patent application No. 201680028738.6, filed on March 30, 2016, entitled "Patient Interface". Technical Field

[0003] This disclosure generally relates to respiratory therapy. More specifically, this disclosure relates to a patient interface for providing respiratory therapy. Background Technology

[0004] Patients with respiratory conditions such as chronic obstructive pulmonary disease (COPD) may struggle to breathe effectively. This difficulty can result from a variety of causes, including weakened lung tissue, small airway dysfunction, excessive sputum accumulation, infection, genetic disorders, or heart failure. In cases of respiratory illness, providing patients with treatments that improve their ventilation is beneficial. A respiratory therapy system can be used to provide high-flow therapy to patients. This system includes a gas source, a patient interface for delivering gas to the patient's airway, and a catheter extending between the gas source and the patient interface. The patient interface is typically unsealed. The gas may be heated and humidified before being delivered to the patient.

[0005] Obstructive sleep apnea (OSA) is a sleep disorder in which the muscles that normally keep the airway open collapse, temporarily closing the airway. The sleep pattern of OSA patients is characterized by repetitive snoring, difficulty breathing, inadequate breathing, starting with waking and then returning to sleep. Continuous positive airway pressure (CPAP) therapy can be used to splint the airway and reduce or eliminate the occurrence of OSA. A respiratory therapy system can be used to provide CPAP therapy to patients, comprising a gas source, a patient interface for delivering gas to the patient's airway, and a catheter extending between the gas source and the patient interface. The patient interface is typically sealed. The gas may be heated and humidified before being delivered to the patient. Summary of the Invention

[0006] For some patients, it is best to deliver food or nutritional supplements via a feeding tube. In many cases, the tube can be inserted through the patient's nose and spirally into, for example, the stomach (for a nasogastric tube), the jejunum (for a nasojejunal tube), or other parts of the digestive tract. Other tubes can be inserted into the patient's nose to deliver medication or measure the patient's characteristics. Similarly, the tube can be inserted through the patient's mouth and spirally into, for example, the stomach (for an orogastric tube), the jejunum (for an orojejunal tube), or other parts of the digestive tract, or for delivering medication or measuring the patient's characteristics. In some configurations, the tube can be placed in both the patient's nose and mouth. Patient interfaces, such as nasal cannulas, can be used to deliver breathing gases to the patient. Managing the amount of space available on the patient's face for tubes and patient interfaces can become difficult, especially for infants or newborns or other patients with limited facial space or small facial geometry. Adjusting or removing tubes without interfering with the delivery of respiratory therapy via a patient interface, or adjusting or removing a patient interface without interfering with the delivery of nutrients or medications via a tube or some other function, can be challenging. In the search for solutions to the aforementioned difficulties, or systems or devices that provide useful alternatives.

[0007] The systems, methods, and apparatuses described herein are innovative in that no single aspect is indispensable or can alone provide their desired properties. Without limiting the scope of the claims, some advantageous features will now be outlined.

[0008] A fixation structure is disclosed based on certain features, aspects, and advantages of one or more embodiments disclosed herein. The fixation structure is adapted to cooperate with a patient interface to secure the patient interface to a patient's face. The fixation structure includes a body having a first region and a second region. The first region is adapted for adhesion to the patient's face. The second region includes a first portion and a second portion. The first portion includes a first fastener adapted for engagement with a complementary second fastener of the patient interface. The second portion is adapted for securing a tube.

[0009] In some configurations, the second portion is adapted to secure the tube within a patient's nasal or oral airway. In some configurations, the second portion is adapted to enclose the tube. In some configurations, the body comprises a rounded rectangular shape. In some configurations, the first fastener comprises a hook portion or a ring portion. In some configurations, the second portion includes an elongated section that is flexible and configured to fold to enclose and secure the tube. In some configurations, the second portion includes an elongated portion extending below the securing structure, the elongated portion being configured to fold over itself to secure the tube.

[0010] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure is disclosed. The fixation structure is adapted to cooperate with a patient interface to secure the patient interface to a patient's face. The fixation structure includes a triangular body having opposing first and second regions. The first region is adapted for adhesion to the patient's face. The second region includes a first portion and a second portion. The first portion includes a first fastener adapted for engagement with a complementary second fastener of the patient interface. The second portion is adapted for securing a tube.

[0011] In some configurations, the triangular body has a shape substantially similar to the Reuleaux triangle. In some configurations, the triangular body includes rounded edges. In some configurations, the second portion is adapted to enclose the tube.

[0012] Additionally, a fixation structure is disclosed based on certain features, aspects, and advantages of one or more embodiments disclosed herein. The fixation structure is adapted to cooperate with a patient interface to secure the patient interface to a patient's face. The fixation structure includes a body having opposing first and second regions. The first region is adapted for adhesion to the patient's face. The second region includes a first portion and a second portion. The first portion includes a first fastener adapted for engagement with a complementary second fastener of the patient interface. The second portion is adapted for securing a tube. The second portion includes a pair of legs extending outwardly from the body. The legs are adapted to wrap around a portion of the tube to secure it.

[0013] In some configurations, the legs are substantially parallel to each other. In some configurations, the legs are offset from each other by an angle of less than 180 degrees. In some configurations, the legs are offset from each other by an angle of less than 90 degrees. In some configurations, the legs are offset from each other by an angle of less than 60 degrees.

[0014] Additionally, a fixation structure is disclosed based on certain features, aspects, and advantages of one or more embodiments disclosed herein. The fixation structure is adapted to cooperate with a patient interface to secure the patient interface to a patient's face. The fixation structure includes a body having opposing first and second regions. The first region is adapted for adhesion to the patient's face. The second region includes a first portion and a second portion. The first portion includes a first fastener adapted for engagement with a complementary second fastener of the patient interface. The second portion is adapted for securing a tube. The second portion includes a shape that substantially complements the edge of the first fastener in use.

[0015] In some configurations, the shape is essentially a modified shape. In some configurations, the modified shape includes two protrusions configured to enclose the tube. In some such configurations, the protrusions are formed by recesses.

[0016] In some configurations, the second portion includes a recess or cutout providing a complementary shape. In some configurations, the second portion is adapted to enclose the tube.

[0017] In some configurations, the tube may include a feeding tube, such as, but not limited to, a nasogastric tube, a nasojejunal tube, an orogastric tube, or an orojejunal tube.

[0018] In some configurations, the fixing structure includes a backing layer adapted to protect the second part.

[0019] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure is disclosed. The fixation structure is adapted to cooperate with a patient interface to secure the patient interface to a patient's face. The fixation structure includes a body having opposing first and second regions. The first region is adapted to be secured to the patient's face. The body includes a flexible portion and at least one separable extension adapted for securing a tube.

[0020] In some configurations, the detachable extension is detached and attached to different portions of the patient's face, and the body includes a second extension that can pivot or fold to secure the tube to the body. In some configurations, the body includes an anchoring section for attaching the patient interface to the body. In some configurations, the detachable extension includes an anchoring section for anchoring or supporting the patient interface. In some configurations, the body supports a portion of the patient interface, and the detachable extension is detached from the body and attached to a spaced-apart portion of the face, also supporting the patient interface. In some such configurations, the patient interface is an unsealed interface, such as a nasal cannula.

[0021] In some configurations, the at least one separable extension includes a weak section. In some configurations, the at least one separable extension is linked to the body via a perforated section.

[0022] In some configurations, the at least one separable extension includes a first region adapted for securing the tube and a second region adapted for securing the patient interface. In some such configurations, the first region of the at least one separable extension includes an adhesive layer. In some such configurations, the adhesive layer is adapted for adhering to the tube. In some configurations, the second region of the at least one separable extension includes a first fastener adapted for engaging with a complementary second fastener of the patient interface.

[0023] In some configurations, the body includes a pair of substantially opposite separable extensions. In some configurations, the body includes a first edge adapted to face the patient's nose or mouth in use, a second edge adapted to face away from the patient's nose or mouth in use, and opposite third and fourth edges extending between the first and second edges. In some such configurations, the pair of separable extensions are linked to the third and fourth edges of the body. In some configurations, the body includes a first edge adapted to face the patient's nose or mouth in use, and a second edge adapted to face away from the patient's nose or mouth in use. In some such configurations, the pair of separable extensions are coupled to the first and second edges of the body.

[0024] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure is disclosed. The fixation structure is adapted to cooperate with a patient interface to secure the patient interface to a patient's face. The fixation structure includes a body having first and second detachable extensions, each of which includes a tube fixing portion adapted to be secured to a tube, and a fixation element adapted to be secured to the patient interface.

[0025] Additionally, a patient interface system is disclosed based on certain features, aspects, and advantages of one or more embodiments disclosed herein. The patient interface system includes a patient interface comprising an attachment structure fixed to a patient-facing portion of the patient interface, the attachment structure being adapted for engagement with a fixation structure fixed to the face to secure the patient interface to the face; and a fixation structure. The fixation structure may be the same as or similar to a fixation structure described above or elsewhere in the description with reference to the accompanying drawings.

[0026] In some configurations, the patient interface includes a first body adapted for resting on a first portion of a patient's face, a second body adapted for resting on a second portion of a patient's face, and a bridging portion connecting the first and second bodies. In some configurations, the attachment structure is fixed to the patient-facing portion of the first and / or second bodies. In some configurations, the patient interface includes a nasal cannula, nasal mask, face mask, oronasal mask, full face mask, unsealed oronasal interface, nasal pillow mask, endotracheal tube, or other such breathing interface.

[0027] Additionally, a fixation structure is disclosed based on certain features, aspects, and advantages of one or more embodiments disclosed herein. The fixation structure is configured to secure a patient interface to a patient. The fixation structure includes a body having a first region and a second region, the first region being configured to contact a portion of the patient's face and the second region being configured to face outwards away from the patient's face. The body includes a first extension and a second extension, the first and second extensions being pivotally attached to the body, the first extension being detachable from the body, and the second extension being configured to pivot relative to the body in use and secure a feeding tube to the body.

[0028] In some configurations, the first extension is detachable from the body during use and positioned on another portion of the patient's face. In some configurations, the first extension includes a first region adapted for securing the tube and a second region adapted for securing the patient interface. In some configurations, the first region of the first extension includes an adhesive layer. In some configurations, the adhesive layer is adapted for adhesion to the tube. In some configurations, the second region of the first extension includes a first fastener adapted for engagement with a complementary second fastener interface of the patient interface. In some configurations, the first and second extensions include a pair of substantially opposite detachable extensions.

[0029] In some configurations, the body includes a first edge adapted to face the patient's nose or mouth in use, a second edge adapted to face away from the patient's nose or mouth in use, and opposing third and fourth edges extending between the first and second edges. In some such configurations, the pair of separable extensions are linked to the third and fourth edges of the body.

[0030] In some configurations, the body includes a first edge adapted to face the patient's nose or mouth in use, and a second edge adapted to face away from the patient's nose or mouth in use. In some such configurations, the pair of separable extensions are attached to the first and second edges of the body.

[0031] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure for use with a patient interface is disclosed. The fixation structure includes a body configured to be adhered to a portion of a patient's face. The body includes at least one separable segment detachable from the body. The separable segment is connected to the body via a weak connection.

[0032] In some configurations, the body includes at least one pivotable segment extending from the body. In some such configurations, the pivotable segment is configured to pivot and connect to a non-patient contact area of ​​the body. In some configurations, the pivotable segment is configured to pivot to secure a feeding tube to the body.

[0033] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure assembly for securing a tube to a patient is disclosed. The fixation structure assembly includes a body, a first extension, and a second extension. The body includes a top region and a bottom region, the bottom region being configured for adhesion to the patient's face. The first extension is connected to a first lateral side of the body via a first intermediate region. The first extension includes a first adhesive portion. The first extension is configured to fold onto the body about a first pivot axis such that the first extension substantially overlaps with and adheres to the body. The second extension is connected to a second lateral side of the body via a second intermediate region. The second extension includes a second adhesive portion and a second fixation element. The second extension is configured to fold onto the body about a second pivot axis such that the second extension substantially overlaps with and adheres to the body.

[0034] In some configurations, the first extension includes a first fixing element configured to engage with a first corresponding fixing element of the patient interface. In some such configurations, the first extension is configured such that, when the first extension overlaps with the body, the first fixing element faces outwards from the patient's face. In some configurations, the second extension includes a second fixing element configured to engage with a second corresponding fixing element of the patient interface. In some such configurations, the second extension is configured such that, when the second extension overlaps with the body, the second fixing element faces outwards from the patient's face.

[0035] In some configurations, the first intermediate region includes a first perforation configured to allow the first extension to separate from the body. In some configurations, the second intermediate region includes a second perforation configured to allow the second extension to separate from the body. In some configurations, the first lateral side and the second lateral side are located on opposite lateral sides of the body. In some configurations, the body further includes a longitudinal axis, and the first pivot axis is substantially parallel to the longitudinal axis. In some configurations, the second pivot axis is substantially parallel to the longitudinal axis. In some configurations, at least one of the first intermediate region and the second intermediate region is configured to receive the tube.

[0036] In some configurations, the first extension further includes a support portion configured to allow a user to engage the support portion with their fingers or a tool. In some configurations, the support portion includes a tab. In some configurations, the fixing structure assembly includes a backing strip with one or more creases.

[0037] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a method for manufacturing a fixation structure assembly adapted for securing a tube to a patient is disclosed. The method includes: obtaining a base portion comprising: a body including a top surface and a bottom surface; a first extension extending from a first lateral side of the body, the first extension including a top surface and a bottom surface; and a second extension extending from a second lateral side of the body, the second extension including a top surface and a bottom surface; applying an adhesive to the top surface of the first extension; attaching a first fixation element to the bottom surface of the first extension; applying an adhesive to the top surface of the second extension; attaching a second fixation element to the bottom surface of the second extension; and applying an adhesive to the bottom surface of the body.

[0038] In some configurations, the method includes: perforating a first intermediate region between the body and the first extension; and perforating a second intermediate region between the body and the second extension.

[0039] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure assembly for securing a tube to a patient is disclosed. The fixation structure assembly includes: a body configured to adhere to the patient's face; and an extension configured to wrap around the tube and connect to the body, thereby securing the tube between the extension and the body. The extension is configured to detach from the body in response to activation of a breakable portion, thereby allowing the tube to detach from the body while remaining within the patient's body.

[0040] In some configurations, the breakable portion includes a perforated portion. In some configurations, the extension is configured to secure the tube by folding the extension onto the tube and adhering the extension to the body. In some configurations, the securing structure includes a second extension connected to the body.

[0041] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a method is disclosed for disengaging a fixation structure from the tube while maintaining the distal end of the tube within the patient's body. The fixation structure includes a body and an extension, the body being connected to the patient's face, and the tube being secured between the extension and the body. The method includes: grasping the tube; moving the fixation structure relative to the tube in a direction not parallel to the longitudinal axis of the tube; activating a breakable portion of the fixation structure; and separating the fixation structure from the tube.

[0042] In some configurations, activating the breakable portion of the fixation structure includes disconnecting a row of perforations. In some configurations, activating the breakable portion of the fixation structure includes disconnecting a first row of perforations and a second row of perforations. In some configurations, activating the breakable portion of the fixation structure further includes separating the portion of the extension located between the first row of perforations and the second row of perforations from the body and the remainder of the extension. In some such configurations, separating the fixation structure from the tube includes removing the body from the tube and separately removing the extension from the tube. In some configurations, the method includes deconnecting the body of the fixation structure from the patient's face.

[0043] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a method is disclosed for replacing a fixation structure for securing the tube to a patient's face while maintaining the distal end of the tube within the patient's body. The method includes: disengaging a first fixation structure and engaging a second fixation structure, wherein engaging the second fixation structure includes: attaching the body of the second fixation structure to the patient's face; positioning the tube along the body of the second fixation structure; circumferentially wrapping an extension of the second fixation structure around a portion of the tube; and securing the tube between the extension of the second fixation structure and the body of the second fixation structure. The first fixation structure may be the same as or similar to a fixation structure described above or elsewhere in the description with reference to the accompanying drawings.

[0044] In some configurations, fixing the tube between the extension of the second fixing structure and the body of the second fixing structure includes: adhering the extension of the second fixing structure to the body of the second fixing structure.

[0045] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure adapted to cooperate with a patient interface for securing the patient interface to a patient's face is disclosed. The fixation structure includes a body and a first extension connected to the body. The body includes a first region adapted for adhesion to the patient's face and a second region adapted to face away from the patient's face. The second region includes a non-adhesive portion. The first extension is configured to fold onto at least a portion of the body. The first extension includes an adhesive portion configured to adhere to the second region of the body when the first extension is folded onto the body.

[0046] In some configurations, the fixing structure includes a second extension connected to the body. In some configurations, the second extension is configured to fold onto at least a portion of the body. In some configurations, the second extension includes a non-adhesive portion configured to adhere to a second region of the body when the second extension is folded onto the body. In some configurations, the first extension and the second extension are located on generally opposite lateral sides of the body.

[0047] In some configurations, the fixation structure includes a perforation configured to allow the first extension to tear from the body. In some such configurations, the perforation is located at the connection between the first extension and the body. In some configurations, the fixation structure includes a second perforation configured to allow the second extension to tear from the body. In some such configurations, the second perforation is located at the connection between the first extension and the body. In some configurations, the fixation structure includes a fixation element adapted to cooperate with the patient interface. In some such configurations, the fixation element includes a hook pad or a ring pad.

[0048] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure for securing a patient interface to a patient's face is disclosed. The fixation structure includes a body comprising opposing first and second regions. The first region includes an adhesive for adhesion to the patient's face. The second region includes a first portion and a second portion. The first portion includes a first fastener for attachment to a complementary second fastener of the patient interface. The second portion is adapted for securing a tube.

[0049] The second portion can be adapted to wrap around the tube. The second portion may include a flexible elongated section adapted to fold over to wrap around and secure the tube. The second portion may include an elongated portion extending below the securing element, adapted to fold over itself to secure the tube. The first fastener may include a hook or loop portion of a hook-and-loop attachment system.

[0050] The body may include a substantially rectangular shape. The body may include a substantially triangular shape. The substantially rectangular or triangular shape of the body may include rounded corners. The second portion may include a shape substantially complementary to the edge of the first fastener. The shape of the second portion may include a substantially shaped form. The second portion may include a pair of legs extending outward from the body, the legs being adapted to wrap around a portion of the tube to secure the tube. The legs may be substantially parallel. The legs may be offset from each other by an angle less than 90 degrees. The legs may be offset from each other by an angle greater than 90 degrees.

[0051] The tube may be a feed tube. The fixing structure may include a backing layer for protecting the second part.

[0052] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure for securing a patient interface to a patient's face is disclosed. The fixation structure includes a body comprising at least one separable extension and opposing first and second regions, the first region including an adhesive for adhesion to the patient's face. The at least one separable extension is adapted for securing a tube.

[0053] The at least one separable extension may include a weak section. The at least one separable extension may be attached to the body via a perforated section. The at least one separable extension may include a first portion adapted for securing the tube and a second portion adapted for securing the patient interface. The first portion of the at least one separable extension may include an adhesive layer for adhering to the tube. The second portion of the at least one separable extension may include a first fastener for attaching to a complementary second fastener of the patient interface. The at least one separable extension may include a pair of separable extensions.

[0054] The body may include a first edge facing the patient's nose or mouth during use, a second edge facing away from the patient's nose or mouth during use, and opposing third and fourth edges extending between the first and second edges, wherein a pair of separable extensions are attached to the third and fourth edges of the body via perforated sections. The body may include a first edge facing the patient's nose or mouth during use, and a second edge facing the patient's nose or mouth during use, wherein a pair of separable extensions are attached to the first and second edges of the body via perforated sections.

[0055] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure configured for securing a patient interface to a patient is disclosed. The fixation structure includes a body. The body includes a first region and a second region. The first region is configured to contact a portion of the patient's face. The second region is configured to face outwards away from the patient's face. The body includes a first extension and a second extension. The first and second extensions are pivotally attached to the body. The first extension is detachable from the body. The second extension is configured to pivot relative to the body and secure a tube to the body.

[0056] The first extension can be configured to detach from the body and be positioned on another portion of the patient's face. The first extension may include a first region adapted for securing the tube and a second region adapted for securing the patient interface. The first region of the first extension may include an adhesive layer. The adhesive layer may be adapted for adhesion to the tube. The second region of the first extension may include a first fastener adapted for attachment to a complementary second fastener of the patient interface. The first and second extensions may include a pair of substantially opposite detachable extensions.

[0057] The body may include a first edge adapted to face the patient's nose or mouth, a second edge adapted to face away from the patient's nose or mouth, and opposing third and fourth edges extending between the first and second edges, wherein the pair of separable extensions are attached to the third and fourth edges of the body via perforated sections. The body may include a first edge adapted to face the patient's nose or mouth, and a second edge adapted to face away from the patient's nose or mouth, wherein the pair of separable extensions are attached to the first and second edges of the body via perforated sections.

[0058] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure for securing a patient interface to a patient's face is disclosed. The fixation structure includes a body comprising an adhesive for adhering to a portion of the patient's face and at least one separable segment capable of being detached from the body. The at least one separable segment is connected to the body via a weak connection.

[0059] The body may include at least one pivotable segment extending from the body. The at least one pivotable segment may be configured to pivot and connect to a non-patient contact area of ​​the body. The at least one pivotable segment may be configured to pivot to secure a tube to the body.

[0060] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure for securing a patient interface to a patient's face is disclosed. The fixation structure includes a body comprising a first region and a second region, the first region including an adhesive for adhesion to the patient's face, and the second region adapted to face away from the patient's face, including a non-adhesive portion. The body includes a first extension connected to the body, the first extension being configured to fold onto at least a portion of the body, the first extension including an adhesive portion for adhesion to the second region of the body when the first extension is folded onto the body.

[0061] The fixing structure may include a second extension. The second extension may be connected to the body. The second extension may be configured to fold onto at least a portion of the body. The second extension may include a non-adhesive portion configured to adhere to a second region of the body when the second extension is folded onto the body. The first extension and the second extension may be located on generally opposite lateral sides of the body.

[0062] The fixing structure may include a first perforation configured to allow the first extension to be torn apart from the body. The first perforation may be located at the connection between the first extension and the body. The fixing structure may include a second perforation configured to allow the second extension to be torn apart from the body. The second perforation may be located at the connection between the second extension and the body.

[0063] The fixation structure may include fixation elements adapted for attachment to the patient interface. The fixation elements may include hook pads or ring pads.

[0064] Additionally, a patient interface system is disclosed based on certain features, aspects, and advantages of one or more embodiments disclosed herein. The patient interface system includes a patient interface comprising an attachment structure fixed to a patient-facing portion of the patient interface, the attachment structure being adapted for connection to a fixation structure interface fixed to the face to secure the patient interface to the face. The patient interface system includes a fixation structure. The fixation structure may be the same as or similar to a fixation structure described above or elsewhere in the description with reference to the accompanying drawings.

[0065] The patient interface may include a first body adapted for resting on a first portion of the face, a second body adapted for resting on a second portion of the face, and a bridging member linking the first and second bodies. The attachment structure may be fixed to the patient-facing portion of the first and / or second bodies. The patient interface may include an unsealed interface. The patient interface may include a sealed interface.

[0066] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure assembly for securing a tube to a patient's face is disclosed. The fixation structure assembly includes a body, a first extension, and a second extension. The body includes a top surface and a bottom surface. The bottom surface includes an adhesive for adhesion to the patient's face. The first extension is connected to a first lateral side of the body via a first intermediate region. The first extension includes a first adhesive portion. The second extension is connected to a second lateral side of the body via a second intermediate region. The second extension includes a second adhesive portion and a second fixation element. The first extension is configured to fold onto the body about a first pivot axis such that the first extension substantially overlaps with and adheres to the body. The second extension is configured to fold onto the body about a second pivot axis such that the second extension substantially overlaps with and adheres to the body.

[0067] The first extension may include a first fixing element for connection to a first corresponding fixing element of the patient interface. The first extension may be configured such that, when the first extension overlaps with the body, the first fixing element faces outwards from the patient's face. The second extension may include a second fixing element configured for connection to a second corresponding fixing element of the patient interface. The second extension may be configured such that, when the second extension overlaps with the body, the second fixing element faces outwards from the patient's face. The first intermediate region may include a first perforation configured to allow separation of the first extension from the body. The second intermediate region includes a second perforation configured to allow separation of the second extension from the body.

[0068] The first and second lateral sides may be located on opposite lateral sides of the body. The body may include a longitudinal axis. The first pivot axis may be substantially parallel to the longitudinal axis. The second pivot axis may be substantially parallel to the longitudinal axis. At least one of the first and second intermediate regions may be configured to receive the tube. The first extension may include a support portion configured to allow a user to engage the support portion with fingers or instruments. The support portion may include a tab. The fixing structure assembly may include a backing strip including one or more creases.

[0069] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a method for manufacturing a fixation structure assembly for securing a tube to a patient is disclosed. The method includes: obtaining a base portion comprising: a body including a top surface and a bottom surface; a first extension extending from a first lateral side of the body, the first extension including a top surface and a bottom surface; and a second extension extending from a second lateral side of the body, the second extension including a top surface and a bottom surface. The method includes applying an adhesive to the top surface of the first extension. The method includes attaching a first fixation element to the bottom surface of the first extension. The method includes applying an adhesive to the top surface of the second extension. The method includes attaching a second fixation element to the bottom surface of the second extension. The method includes applying an adhesive to the bottom surface of the body.

[0070] The method may include perforating a first intermediate region between the body and the first extension. The method may also include perforating a second intermediate region between the body and the second extension.

[0071] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixation structure assembly for securing a tube to a patient is disclosed. The fixation structure assembly includes: a body including an adhesive for adhesion to the patient's face; and an extension configured to wrap around the tube and connect to the body, thereby securing the tube between the extension and the body. The extension is configured to detach from the body in response to activation of a breakable portion, thereby allowing the tube to be separated from the body while remaining within the patient's body.

[0072] The breakable portion may include a perforated portion. The extension may be configured to secure the tube by folding the extension onto the tube and adhering the extension to the body. The fixing structure assembly may include a second extension connected to the body.

[0073] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a method is disclosed for disengaging a fixation structure from the tube while maintaining the distal end of the tube within the patient's body. The fixation structure includes a body and an extension. The body is connected to the patient's face. The tube is secured between the extension and the body. The method includes: grasping the tube; moving the fixation structure relative to the tube in a direction not parallel to the longitudinal axis of the tube; activating a breakable portion of the fixation structure; and separating the fixation structure from the tube.

[0074] Activating the breakable portion of the fixing structure may include disconnecting a row of perforations. Activating the breakable portion of the fixing structure may include disconnecting the first row of perforations and disconnecting the second row of perforations.

[0075] Activating the breakable portion of the fixing structure may include separating the portion of the extension located between the first row of perforations and the second row of perforations from the body and the remainder of the extension. Separating the fixing structure from the tube may include removing the body from the tube and separately removing the extension from the tube.

[0076] The method may include detaching the body of the fixation structure from the patient's face.

[0077] Additionally, based on certain features, aspects, and advantages of one or more embodiments disclosed herein, a method is disclosed for replacing a fixation structure for securing the tube to a patient's face while maintaining the distal end of the tube within the patient's body. The method includes disengaging a first fixation structure and engaging a second fixation structure. Disengaging the first fixation structure includes methods that are the same as or similar to one or more methods of disengaging fixation structures described in the foregoing paragraphs or elsewhere in this specification with reference to the accompanying drawings. Engaging the second fixation structure includes: attaching the body of the second fixation structure to the patient's face; positioning the tube along the body of the second fixation structure; circumferentially wrapping an extension of the second fixation structure around a portion of the tube; and securing the tube between the extension of the second fixation structure and the body of the second fixation structure.

[0078] Securing the tube between the extension of the second fixing structure and the body of the second fixing structure may include: adhering the extension of the second fixing structure to the body of the second fixing structure. Attached Figure Description

[0079] Referring to the following figures, specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein.

[0080] Figure 1 An exemplary respiratory therapy system is shown.

[0081] Figure 2 A front view showing an exemplary embodiment of the patient interface.

[0082] Figure 3 Showing Figure 2 The rear view of the patient interface.

[0083] Figure 4 Showing Figure 2 The patient interface is shown from the side perspective.

[0084] Figures 5A-5D An exemplary embodiment of the fixed structure is shown.

[0085] Figures 6A-6C An exemplary embodiment of the fixed structure is shown.

[0086] Figures 7A-7B An exemplary embodiment of the fixed structure is shown.

[0087] Figures 8A-8D An exemplary embodiment of the fixed structure is shown.

[0088] Figures 9A-9B An exemplary embodiment of the fixed structure is shown.

[0089] Figures 10A-10C An exemplary embodiment of the fixed structure is shown.

[0090] Figure 11A-11B An exemplary embodiment of the fixed structure is shown.

[0091] Figure 12A-12B Showing Figure 11A-11B Exemplary use of a fixed structure.

[0092] Figures 13A-13B An exemplary embodiment of the fixed structure is shown.

[0093] Figures 14A-14B Showing Figures 13A-13B Exemplary use of a fixed structure.

[0094] Figures 15A-15B An exemplary embodiment of the fixed structure component is shown.

[0095] Figure 15C Showing Figure 15B The fixed structural component is along the section of line AA.

[0096] Figures 16A-16B Showing Figures 15A-15B Exemplary uses of fixed structural components.

[0097] Figures 17A-17E An exemplary embodiment of the fixed structure is shown.

[0098] Figure 18 An exemplary embodiment of the fixed structure is shown. Detailed Implementation

[0099] Figure 1 An exemplary respiratory therapy system 100 is illustrated. A patient 1 receives humidified and pressurized gas via a patient interface 200 (shown in this example as a nasal cannula assembly), which is connected to a humidified gas delivery path or inhalation conduit 3, which in turn connects to a humidifier 8 (including a humidification chamber 5), supplied with gas from a gas supply device or blower 15 or other suitable gas supply device. Gas can be supplied from a source external to and / or separate from the respiratory therapy system 100, or from a source internal to and / or integrated with the respiratory therapy system 100. A headgear 20 is provided to support and hold the patient interface on the patient's face. The inhalation conduit 3 is coupled to an outlet 4 of the humidification chamber 5, which contains a volume of water 6. The humidification chamber 5 is preferably formed of a plastic material and may have a highly thermally conductive base (e.g., an aluminum base) that is in direct contact with the heater plate 7 of the humidifier 8. The humidifier 8 is equipped with a control mechanism or electronic controller 9, such as a microprocessor-based controller that executes computer software commands stored in associated memory. Gas flowing through the breathing tube 3 is delivered to the patient via the patient interface 200.

[0100] Controller 9 receives input from a source or input device (e.g., dial 10) through which a user (e.g., a nurse or other care provider) can, for example, set a predetermined desired value (preset value) for the humidity or temperature of the gas supplied to the patient. In response to the user-set humidity or temperature value input via dial 10, and other possible inputs (e.g., internal sensors sensing gas flow or temperature), or in response to parameters calculated in controller 9, controller 9 determines when (or to what extent) to power heater plate 7 to heat water 6 within humidification chamber 5. When a measured amount of water 6 within humidification chamber 5 is heated, water vapor begins to fill the volume above the surface of water 6 within humidification chamber 5 and exits from outlet 4 along with the flow of gas (e.g., air) supplied by blower 15, entering humidification chamber 5 through inlet 16. It should be noted that the relationship between the humidity of the gas in humidification chamber 5 and the temperature of heater plate 7 can be determined. Therefore, the humidity of the gas can be determined using the temperature of heater plate 7 in an algorithm or lookup table.

[0101] Blower 15 may be equipped with a variable speed pump or fan 2 that draws in air or other gases through blower inlet 17. The speed of variable speed pump or fan 2 may be controlled by an additional control device or electronic controller 18 in response to input from controller 9 and a predetermined required value (preset value) of pressure and / or fan speed set by the user via one or more input devices (e.g., dial 19) (or alternatively, the function of controller 18 may be performed by controller 9).

[0102] A heating element 11 can be provided within the conduit 3 to help prevent condensation of the humidified gas within the conduit 3. Such condensation occurs because the temperature of the walls of the conduit 3 is close to ambient temperature (the temperature of the surrounding atmosphere), which is typically lower than the temperature of the humidified gas within the conduit 3. The heating element 11 effectively compensates for the energy lost by the gas during its transmission through the conduit 3 due to conduction and convection. Therefore, the heating element 11 ensures that the delivered gas is at optimal temperature and humidity.

[0103] In the illustrated configuration, patient interface 200 is a nasal cannula. In some configurations, patient interface 200 may include a sealed or unsealed interface. For example, patient interface 200 may be a nasal mask, face mask, oronasal mask, full face mask, nasal cannula, unsealed oronasal interface, nasal pillow mask, endotracheal tube, a combination of the above, or some other gas delivery system or device. In some configurations, patient interface 200 may be used to deliver breathing gases in a respiratory therapy system that does not include a humidifier. For example, patient interface 200 may be used to deliver a mixture of ambient air and oxygen in an oxygen therapy system. Certain features, aspects, and advantages of the illustrated nasal cannula may be envisioned in other patient interfaces.

[0104] Figure 2-4 A non-limiting exemplary embodiment of the patient interface 200 is shown. The patient interface 200 can generally be shaped or configured such that it substantially conforms to the contours of a patient's face. The patient interface 200 includes a first nasal delivery element 202A and a second nasal delivery element 202B that rest in the patient's nostrils during use. The shown nasal delivery elements 202A and 202B are substantially tubular and guide gas through the patient interface 200 to the patient. The nasal delivery elements 202A and 202B can be shaped and angled such that they generally extend inward toward the patient's nasal septum during use. The nasal delivery elements 202A and 202B terminate at tips 202A' and 202B'. In use, the tips 202A' and 202B' point toward the back of the patient's head.

[0105] In some configurations, the nose delivery elements 202A and 202B can have different shapes. For example, while the general cross-section of the nose delivery elements 202A and 202B is substantially circular in the illustrated configuration, in some configurations, the cross-section of the nose delivery elements 202A and 202B can be substantially elliptical, substantially square, or substantially rectangular. In some configurations, the cross-section of the nose delivery elements 202A and 202B can vary along the length of the nose delivery elements 202A and 202B. In some configurations, the nose delivery elements 202A and 202B can each have different characteristics. For example, nose delivery element 202A can be smaller or shorter than nose delivery element 202B. In some configurations, only one of the nose delivery elements 202A and 202B can be used.

[0106] Nasal delivery elements 202A and 202B extend from a first body 206A and a second body 206B of the patient interface 200. The bodies 206A and 206B include gas delivery lumens 210A and 210B that receive gas from gas inlets 208A and 208B of the bodies 206A and 206B and guide this gas to the nasal delivery elements 202A and 202B. The gas inlets 208A and 208B are connected to a pair of gas delivery conduits 218A and 218B (see [link to documentation]). Figure 1 In the illustrated configuration, gas delivery conduits 218A and 218B are integrally formed with or inseparably connected to gas inlets 208A and 208B. Furthermore, gas delivery conduits 218A and 218B can be integrally formed with or inseparably connected to gas conduit connector 222. Gas conduit connector 222 can be releasably coupled to complementary connector 118, which is connected to gas conduit 110 (see attached diagram). Figure 1 Elsewhere in this disclosure, catheter 3) is described as being in ventilated communication. Other configurations are considered. For example, in some configurations, the patient interface 200 may be configured such that the nasal delivery elements 202A, 202B receive gas from one of the gas delivery lumens 210A, 210B located in one of the bodies 206A, 206B. In some such configurations, this gas delivery lumen 210A, 210B may further receive gas from one of the gas delivery catheters 218A, 218B.

[0107] In some configurations, one of the gas inlets 208A and 208B may be directly connected to the gas conduit 110 (or indirectly connected via complementary connector 118 and / or gas conduit connector 222). In some such configurations, the bodies 206A and 206B may be integrally formed with the gas conduit 110 or may be together with it as a single continuous piece. In some configurations, one or more of the gas delivery conduits 218A and 218B are removably connected to one or more of the gas inlets 208A and 208B. In some configurations, one or more of the gas delivery conduits 218A and 218B are removably connected to the gas conduit connector 222.

[0108] The bodies 206A and 206B of the patient interface 200 can be placed on the patient's face during use. In the illustrated configuration, the bodies 206A and 206B rest on the cheeks of the patient's face. To secure the bodies 206A and 206B in place on the patient's face, the bodies 206A and 206B are equipped with attachment structures 216A and 216B. In a non-limiting example, the attachment structures 216A and 216B maintain the patient interface 200 in a desired alignment with the patient's face, allowing the nasal delivery elements 202A and 202B to be comfortably and loosely positioned in the nostrils.

[0109] Attachment structures 216A and 216B can be connected to a fixation structure attached to the face. In some configurations, attachment structures 216A and 216B and the fixation structure are complementary to each other. Attachment structures 216A and 216B and the fixation structure can be connected, for example, via a hook-and-loop connection, such that attachment structures 216A and 216B include loop portions (e.g., constructed of textile or plastic) that connect to complementary hook portions of the fixation structure. Other configurations are also considered. In some configurations, attachment structures 216A and 216B can be directly attached to the patient's face, for example, using an adhesive pad or other structure. In some configurations, a single attachment structure can be used. In some configurations, more than two, such as three or four attachment structures, can be used.

[0110] In some configurations, attachment structures 216A, 216B may include features that are not 'loop' portions. For example, attachment structures 216A, 216B may include 'hook' portions that engage with complementary 'loop' portions on the fixation structure. As another example, attachment structures 216A, 216B may include snap-fit ​​features or other mechanical interlocking features that engage with complementary features on the fixation structure. In some configurations, headgear 20 may secure patient interface 200 to the face in a desired orientation or alignment. Headgear 20 may include, for example, one or more straps that extend around the patient's head during use, buckles for adjusting the tightness of the straps by modifying their effective length, a cap, bandana, hat, helmet, and / or one or more other features.

[0111] A bridging portion 204 connects the bodies 206A and 206B. The bridging portion 204 helps maintain the nasal delivery elements 202A and 202B in a desired orientation relative to each other. In some configurations, the bridging portion 204 is an extension of the bodies 206A and 206B and is constructed of the same material. In some configurations, the bridging portion 204 is constructed of a different material than the bodies 206A and 206B. In some configurations, the bridging portion 204 does not have a gas cavity. In some configurations, the bridging portion 204 may be opened, for example via a gas cavity that fluidly connects the nasal delivery elements 202A and 202B, to provide gas transport between the bodies 206A and 206B. In some such configurations, only one of the bodies 206A and 206B has a gas cavity and / or a gas inlet. In some configurations, the bridging portion 204 extends between the first connection point on the body 206A and the second connection point on the body 206B.

[0112] like Figure 3As shown, the width of the bodies 206A and 206B can decrease (along the direction W) as they extend toward the nasal delivery elements 202A and 202B and the bridging portion 204. Attachment structures 216A and 216B are positioned on relatively wide portions of the bodies 206A and 206B, at or near the outer edges of the bodies 206A and 206B, to improve the stability of the patient interface 200 on the patient's face when used with the fixation structure. For example, attachment structures 216A and 216B can be positioned on or near the distal portions of the bodies 206A and 206B relative to the nasal delivery elements 202A and 202B. Attachment structures 216A and 216B can substantially cover the patient-facing areas of the bodies 206A and 206B that face the patient's face and face away from the patient interface during use. The attachment structures 216A and 216B may at least partially cover the patient-facing areas of the bodies 206A and 206B. The attachment structures 216A and 216B may be positioned within at least a partially recessed area of ​​the bodies 206A and 206B.

[0113] Further reference Figure 2 and 4 The outer edges of bodies 206A and 206B may include split structures 212A and 212B. Split structures 212A and 212B are positioned on the interface-facing regions of bodies 206A and 206B that face the patient interface and away from the patient's face during use. Split structures 212A and 212B are spaced apart from gas inlets 208A and 208B. In the illustrated configuration, split structures 212A and 212B are tabs that include internal regions with a reduced thickness 213A and 213B relative to adjacent portions of bodies 206A and 206B. Outside the inner regions with reduced thicknesses 213A, 213B and toward the outer edges of the bodies 206A, 206B, the split structures 212A, 212B include outer regions 215A, 215B of normal thickness or increased thickness relative to adjacent portions of the bodies 206A, 206B.

[0114] The split structures 212A and 212B are configured such that the outer regions 215A and 215B can be grasped and pulled by a patient or another person (e.g., a healthcare professional, such as, but not limited to, a nurse or physician). When pulled, sufficient force can be applied to the patient interface 200 to disattach the attachment structures 216A and 216B from the fixed structures attached to the patient's face. Therefore, the split structures 212A and 212B can be used to more easily detach the patient interface 200 from the patient's face. Other configurations are considered. For example, in some configurations, a split structure may be positioned on a single body within the bodies 206A and 206B of the patient interface 200. In some configurations, the patient interface 200 may include more than two (e.g., three or four) split structures. In some configurations, the split structures 212A and 212B may be positioned on other portions of the bodies 206A and 206B, or on other portions of the patient interface 200. In some configurations, the split structures 212A, 212B may include structures other than the tabs. For example, the split structures 212A, 212B may include flat extensions of the bodies 206A, 206B that can be pulled or otherwise manipulated to separate the patient interface 200 from the patient's face.

[0115] Figures 5A-5D An exemplary embodiment of the fixation structure 300 is shown. The fixation structure 300 may have a patient-facing area connected to the patient's face. Figure 5A An example of a patient-facing area of ​​the fixation structure 300 is shown. In some embodiments, the fixation structure 300 has an interface-facing area attached to the patient interface 200. Figure 5C An example of an interface-facing region of the fixed structure 300 is shown. In some configurations, the patient-facing region is located on a first side of the fixed structure 300, and the interface-facing region is located on the opposite second side of the fixed structure 300. As described in more detail below, portions of the fixed structure 300 can be folded and / or flipped. This allows a portion of the first side of the fixed structure 300 to change from facing the patient to facing the interface, and a portion of the second side of the fixed structure 300 to change from facing the interface to facing the patient.

[0116] As indicated above, the fixation structure 300 can be attached to the patient interface 200. For example, the fixation structure 300 can be releasably attached to attachment structures 216A, 216B to secure the patient interface 200 to the patient's face. In some embodiments, the fixation structure 300 can secure a tube (e.g., a nasogastric tube, nasojejunal tube, orogastric tube, or orojejunal tube) to the patient's face without the need for tape.

[0117] In the illustrated configuration, the fixation structure 300 includes a body 302. The body 302 has a substantially uniform thickness T. In some configurations, the body 302 has a variable thickness along its length L and / or width W. The body 302 may be constructed of a material that allows the patient-facing area of ​​the fixation structure 300 to be releasably bonded to the patient's face. In the illustrated configuration, the material is an adhesive material, such as a hydrocolloid-based adhesive material, a zinc oxide-based adhesive material, a silicone-based adhesive material, or a hydrogel-based material. Figure 5B As shown, the patient-facing area of ​​the fixation structure 300 that integrates with the patient's face may be covered with a first backing layer 314, which protects the adhesive properties of the body 302. Before applying the fixation structure 300 to the patient's face, the first backing layer 314 can be removed from the body 302 to expose the adhesive material of the body 302.

[0118] The body 302 includes a first edge 304 that faces the patient's nose and / or mouth during use. In the illustrated configuration, the first edge 304 is substantially rounded and its width tapers towards an extension or button-like portion of the body 302. The body 302 includes a second edge 306 that faces away from the patient's nose and / or mouth during use. In the illustrated configuration, the second edge 306 is substantially rounded and its width tapers slightly. Opposite third edges 308A and fourth edges 308B of the body 302 extend between the first edge 304 and the second edge 306. The third edge 308A and / or the fourth edge 308B may be curved.

[0119] The interface-facing area of ​​the fixation structure 300 includes a fixation element 310. The fixation element 310 can engage with attachment structures 216A, 216B to secure the patient interface 200 to the patient's face. In the illustrated configuration, the fixation element 310 includes hook pads for releasable attachment to loop pads of attachment structures 216A, 216B to form a hook-and-loop connection. The hook pads can be attached to the fixation structure 300 by, for example, adhesives, ultrasonic welding, high-frequency welding, suturing, or chemical bonding. In other configurations, the fixation element 310 may include other structures or elements that can be coupled to attachment structures 216A, 216B, including but not limited to: latches that can be coupled to complementary latches of attachment structures 216A, 216B; latches that can be coupled to complementary latches of attachment structures 216A, 216B; complementary adhesives; pins; retaining rings; or other mechanical fasteners. In some variations, the retaining element 310 includes a ring pad for releasably attaching to the hook pads of attachment structures 216A, 216B to form a hook-and-loop connection.

[0120] Figure 5DAn exemplary embodiment of the fixing structure 300 is shown. In the illustrated configuration, the fixing element 310 includes a hook pad with a serpentine shape. The serpentine shape defines a gap 312 between adjacent masses of the fixing element 310. The gap 312 improves the flexibility of the fixing element 310. In some configurations, the gap 312 improves the flexibility of the fixing element 310 when the fixing structure 300 is positioned to twist about an axis substantially parallel to the first edge 304 and / or the second edge 306. In some configurations, the gap 312 may be a cut, slot, perforation, or thin region formed in the fixing element 310. The orientation of the gap 312 can be varied to accommodate different directions of torsion and / or applied force.

[0121] In some configurations, the fixing element 310 may exhibit increased flexibility when subjected to torsion about an axis substantially parallel to the first edge 304 and / or the second edge 306. For example, in some configurations, the fixing element 310 may be constructed of a mechanically anisotropic material that exhibits increased flexibility when subjected to torsion about an axis substantially parallel to the first edge 304 and / or the second edge 306. In yet another configuration, the fixing element 310 may be constructed of a variety of materials with different flexibility. These materials may be layered along the length of the fixing element 310.

[0122] Figures 6A-6C An exemplary embodiment of the fixed structure is shown. Figure 6A An exemplary configuration of the interface-facing region of the fixing structure 300 is shown. In the shown configuration, the fixing structure 300 has a triangular shape, or a shape substantially similar to a Reuleaux triangle with rounded edges, or a shape similar to a 'guitar plectrum'. The shape can be substantially symmetrical. The symmetrical shape allows the fixing structure 300 to be positioned on either side of the nose and mouth while retaining the same mechanical features without requiring rotation or reorientation.

[0123] In the illustrated configuration, the fixing element 310 may include a slot pattern in which a plurality of slots extend inward from the outer edge of the fixing element 310 in the width direction toward the center of the fixing element 310. The illustrated slots do not extend across the entire fixing element 310.

[0124] See further Figure 6AThe fixing element 310 is positioned on a first portion of the interface-facing region of the fixing structure 300. A second backing layer 316 is positioned on a second portion of the interface-facing region of the fixing structure 300. The second backing layer 316 may be defined by a third edge 308A, as shown in the illustrated configuration. The second backing layer 316 can be removed by applying a force F to the second backing layer 316 to peel it off from the interface-facing region of the fixing structure 300. In some configurations, the second backing layer 316 may extend beyond one or more edges of the body 302 of the fixing structure 300 to facilitate gripping of the second backing layer 316 by a patient or user, such as a nurse or other care provider.

[0125] like Figure 6B As shown, after the second backing layer 316 is removed from the body 302, the tube 400 can be positioned on the second portion of the interface-facing region of the fixing structure 300. The tube 400 may include one or more of a variety of tubes, including but not limited to: feeding tubes, such as nasogastric tubes, orogastric tubes, nasojejunal tubes, or orojejunal tubes; drug delivery tubes; or sensing or measuring tubes (for determining different parameters, including but not limited to gas pressure or gas concentration). The second portion of the interface-facing region of the fixing structure 300 may be folded onto itself and adhered to itself, adhered to the first portion of the interface-facing region of the fixing structure 300, and / or adhered to the tube 400 to secure the tube 400 to the fixing structure 300.

[0126] In some configurations, the tube retention adhesive may be positioned on a second portion of the interface-facing region of the fixing structure 300, beneath the second backing layer 316. The tube retention adhesive may have different adhesive properties than the adhesive material used on or applied to the body 302. For example, in some configurations, the tube retention adhesive may include a first adhesive to retain the tube 400 to the fixing structure 300, and the body 302 may be formed of or include a second adhesive to secure the fixing structure 300 to the face. In some configurations, the first and second adhesives may be different; for example, the tube retention adhesive may include a hydrocolloid-based adhesive, and the body 302 may be formed of or include a silicone-based adhesive. In some configurations, the first and second adhesives may be the same. In some configurations, the first and second adhesives may be from the same class of materials.

[0127] In some configurations, the tube retention adhesive comprises an adhesive with a lower tack than the adhesive of the body 302. For example, the tube retention adhesive may have relatively low adhesive strength, and the body 302 may be formed of or comprise an adhesive with relatively high adhesive strength. This configuration of the adhesive is useful if it is desirable to remove or adjust the tube 400 without unintentionally removing or adjusting the patient interface used with the fixation structure 300.

[0128] Although Figures 6A-6C It was demonstrated that a fixing structure 300 with a triangular shape, or a shape substantially similar to a Reuleaux triangle with rounded edges, or a 'guitar pick' shape, can fix the tube 400, but in other configurations, other shapes can be used for the fixing structure 300. For example, Figures 7A-7B A fixed structure 300 with a rectangular shape is shown. Other shapes are also considered, including but not limited to: squares, rectangles, triangles, circles, or hexagons. In some configurations, modifications to the shape can be considered, such as rounded edges, curvature, or slight taper.

[0129] Figures 8A-8B An exemplary shape of the fixing structure 300 for securing the tube 400 is shown. In the illustrated configuration, a second portion of the interface-facing area of ​​the fixing structure 300 includes one or more legs 319 extending outward from the body 302. In the illustrated embodiment, two legs 319 are shown. In some embodiments, more than two legs 319 may be present. The legs 319 are substantially parallel to each other and located on opposite sides of a third edge 308A of the body 302; for example, one of the legs 319 is located near a first edge 304, and another of the legs 319 is located near a second edge 306. Some or all of the legs 319 may include an adhesive that allows the legs 319 to fold back onto the body 302 to secure the tube 400. The tube 400 may be positioned at a fold between the legs 319 and the body 302, on the legs 319 (as shown), or on the body 302, and thus held in place by the legs 319. In some embodiments, when folded, the legs 319 extend into the body 302. The adhesive on the legs 319 may be covered by one or more backing layers (e.g., a second backing layer 316). The positioning of the legs 319 on the third edge 308A can uniformly support the tube 400 while allowing the reading of numbers or other markings present on the tube 400 in the gaps between the legs 319.

[0130] In other configurations, such as Figure 8C As shown, the legs 319 may be offset from each other at an angle x. In some embodiments, the angle x is less than about 180 degrees, or less than about 60 degrees, or between about 60 degrees and about 180 degrees. Figure 8DThe illustration shows the leg 319 folded to hold the tube 400 and attached to the body 302. In the folded position, the leg 319 extends beside the fixing element 310. The fixing element 310 is configured such that it is not obstructed or covered by the leg 319. The tube 400 is positioned at the folded portion between the leg 319 and the body 302. Alternatively, the tube 400 may be positioned on the body 302, between the folded portion and the fixing element 310.

[0131] Figures 9A-9B An exemplary shape of the fixing structure 300 for securing the tube 400 is shown. In the illustrated configuration, a second portion of the interface-facing area of ​​the fixing structure 300 includes a recess or cutout along the third edge 308A of the body 302. The cutout is substantially curved and, when folded onto the tube 400, is substantially complementary to the edge of the fixing element 310 (in the illustrated configuration, the edge facing the third edge 308A of the body 302). The cutout maximizes the exposed area of ​​the fixing element 310 by not obscuring or covering it, without increasing the size of the fixing structure 300. If the cutout is complementary to the edge of the fixing element 310, an aesthetically pleasing and ergonomic shape can be achieved.

[0132] Figures 10A-10C An exemplary configuration of the fixing structure 300 for securing the tube 400 is shown. In the illustrated configuration, a portion of the body 302 can be bifurcated to provide a wrapping effect for the tube 400. Figure 10B As shown, body 302 is divided into two parts near its central portion, thus creating branch point J. Upper portion 302 of body 302 u and the lower part of the main body 302 l Extending from the branch point J toward the third edge 308A of the body 302. Upper portion 302 of the body. u and the lower part of the main body 302 l The internal portion is covered by an upper second backing layer 318A and a lower second backing layer 318B, beneath which are corresponding upper and lower adhesives. Similar to bonding elsewhere in this disclosure. Figures 6A-6CThe described tube-retaining adhesive, wherein the upper and lower adhesives have adhesive properties or adhesive strengths that may differ from those of the adhesive material used on or attached to the body 302. In some configurations, the upper and lower adhesives may have adhesive properties or adhesive strengths that are the same as or similar to those of the adhesive material used on or attached to the body 302. To utilize the illustrated fixing structure 300, the first backing layer 314 may be removed to expose an adhesive surface that can adhere to the face. After removing the upper second backing layer 318A and the lower second backing layer 318B, the tube 400 can be positioned on the upper portion 302 of the body. u Below and in the lower part of the body 302 l Above, so that it is fixed to the upper part 302 of the main body. u With the lower part of the main body 302 l Between. In some configurations, the fixed structure 300 may include other shapes, including but not limited to triangular shapes with / without rounded edges, as referred to elsewhere in this disclosure. Figures 7A-7B As described.

[0133] Figure 11A-11B An exemplary configuration of a fixing structure 300 for fixing the tube 400 is shown. The shown fixing structure 300 includes a body 302. Figure 11A The interface-facing area of ​​body 302 is shown, and Figure 11B The patient-facing area of ​​body 302 is shown. Body 302 is formed of or includes an adhesive material for adhesion to a patient's face during use. In the shown configuration, body 302 is formed of or includes a hydrocolloid-based adhesive material. Body 302 includes a first edge 304 facing the patient's nose or mouth during use, and a second edge 306 facing away from the patient's nose or mouth during use. Opposite third edges 308A and fourth edges 308B extend between the first edge 304 and the second edge 306. As shown, in some configurations, the third edge 308A and fourth edge 308B are curved. In some configurations, the curve is at least partially concave relative to the third edge 308A and fourth edge 308B. The curve may substantially correspond to the contour of the eye or eyelid. When a force is applied to the body 302 of the fixed structure 300 that pushes the body 302 toward the eye or eyelid, the curvature increases the tendency of the body 302 to cover the lower eyelid or move around the contour of the lower eyelid, and reduces the tendency of the body 302 to move into or near the eye or eyelid.

[0134] The third edge 308A and the fourth edge 308B may extend from the centerline or central portion of the body 302 at the portions of the third edge 308A and the fourth edge 308B closest to the first edge 304 and the second edge 306, than at the portions of the third edge 308A and the fourth edge 308B furthest from the first edge 304 and the second edge 306 (e.g., the central portion of the third edge 308A and the fourth edge 308B). In some configurations, the portions of the third edge 308A and the fourth edge 308B closest to the second edge 306 may extend from the centerline or central portion of the body 302 more than the portions of the third edge 308A and the fourth edge 308B closest to the first edge 304.

[0135] The body 302 includes a pair of separable extensions 332A and 332B. In the illustrated configuration, the separable extensions 332A and 332B are formed of the same material as the body 302. In some configurations, the separable extensions 332A and 332B are formed of a different material than the body 302. The separable extensions 332A and 332B may be substantially airfoil-shaped. The separable extensions 332A and 332B may be at least partially linked to the body 302 at the third edge 308A and the fourth edge 308B of the body 302 and may extend outward from the body 302. The separable extensions 332A and 332B are linked to the body 302 through perforated sections 330A and 330B. The perforated sections 330A and 330B may be torn open to allow the separable extensions 332A and 332B to be separated from the body 302. In some configurations, one of the perforated sections 330A and 330B can link the body 302 to the separable extensions 332A and 332B. In some configurations, multiple perforated sections 330A and 330B (e.g., two, three, or four perforated sections) can link the body 302 to the separable extensions 332A and 332B.

[0136] Separable extensions 332A and 332B secure or wrap the tube 400. For example... Figure 11A As shown, on the sides of the separable extensions 332A and 332B corresponding to the interface-facing area of ​​the body 302, the separable extensions 332A and 332B include adhesive layers 334A and 334B for securing the tube 400. Adhesive layers 334A and 334B may be formed of or include an adhesive suitable for adhesion to the plastic feed tube, including but not limited to hydrocolloid-based adhesives and acrylic-based adhesives. One or more of adhesive layers 334A and 334B may be covered with a backing layer to protect the adhesive properties of the adhesive layers 334A and 334B.

[0137] In some embodiments, the fixing structure 300 includes adhesive and non-adhesive portions. For example, the interface-facing region of the body 302 may be non-adhesive, and the interface-facing regions of the separable extensions 332A, 332B may be adhesive, or vice versa. This can aid in removing the fixing structure 300 from the tube 400, for example, by tearing the fixing structure 300 along a row of perforations and separating the fixing structure 300 from the tube 400 via a tear seam. It has been found that in some implementations, when both the body 302 and the extensions 332A, 332B are adhesive, the fixing structure 300 can become over-attached to itself. This can hinder the removal of the fixing structure 300 from the tube 400, for example, by interfering with the ability to tear along the perforations. However, in some implementations, when only one of the body 302 and the separable extensions 332A, 332B includes an adhesive portion, the adhesion of the fixing structure 300 to itself does not excessively prevent the removal of the fixing structure 300 from the tube 400.

[0138] like Figure 11B As shown, on the side of the separable extensions 332A and 332B corresponding to the patient-facing area of ​​the body 302, the separable extensions 332A and 332B include fixing elements 336A and 336B. Each fixing element 336A and 336B is coupled to one of the attachment structures 216A and 216B in accordance with [see elsewhere in this disclosure]. Figure 3 The described fixation elements 310 engage in the same or similar manner. In the illustrated configuration, fixation elements 336A, 336B include 'hook' pads for engagement with attachment structures 216A, 216B to achieve a 'hook-and-loop' connection. In some embodiments, fixation structure 300 may adhere to other surfaces, such as patient skin, tube 400, etc. For example, fixation structure 300 may include one or more adhesive portions and one or more non-adhesive portions. In some embodiments, one or both of the separable extensions 332A, 332B include adhesive portions.

[0139] Figure 12A and 12B Showing Figure 11A and 11B The purpose of the fixation structure 300 is shown. A close-up of the patient's face, including the nose (N) and mouth (M), is shown. Focus is placed on... Figure 12A and Figure 12B For the left side portion, in order to use the fixing structure 300, one of the separable extensions 332B (e.g., ...) can be removed from the body 302. Figures 16A-16B(As shown). The body 302 can be adhered to the left side of the face below the nose N and above the mouth M. The tube 400 can then be positioned on the body 302. The backing layer above the adhesive layer 334A present on the remaining separable extension 332A can be removed to expose the adhesive layer 334A. The tube 400 can be covered and held in place by grasping the separable extension 332A and folding it onto the tube 400 in the direction R1. The adhesive layer 334A can be used to secure the tube 400 to the body 302. When folded, the fixing element 336A of the separable extension 332A is exposed, allowing the fixing element 336A to engage with the corresponding attachment structure 216A of the patient interface 200. The separable extension 332A can be positioned such that it is close to the eye or away from the eye before folding.

[0140] Focus Figure 12A and Figure 12B The right side portion can be used on the other side of the face by rotating the fixation structure 300 (or the second fixation structure) 180 degrees in direction R2. In this case, the detachable extension 332A can be removed. When folded, the fixation element 336B of the fixation structure 300 is exposed so that it can be coupled to the corresponding attachment structure 216B of the patient interface 200. The detachable extension 332B can be positioned such that it is close to the eye or away from the eye before folding. In some embodiments, the fixation structure 300 is not used to hold the tube 400. In some embodiments, each of the plurality of fixation structures can hold one or more tubes.

[0141] Figures 13A-13B An exemplary configuration of a fixing structure 500 for fixing the tube 400 is shown. The shown fixing structure 500 includes a body 502. Figure 13A The interface-facing area of ​​body 502 is shown, and Figure 13B The patient-facing area of ​​the body 502 is shown. This patient-facing area is formed of or includes an adhesive material for adhesion to the patient's face. In the shown configuration, the body 502 is formed of or includes a hydrocolloid-based adhesive material. The body 502 includes opposing first edges 503A and second edges 503B. Each of the first edges 503A and second edges 503B faces or faces away from the patient's nose or mouth during use. The fixation structure 500 can be substantially symmetrical, eliminating the need to rotate the fixation structure 500 to secure it to one side of the face. Figure 13AAs shown, the body 502 includes a tube retention adhesive 508 on a portion of its interface-facing area. In some embodiments, the tube retention adhesive 508 may cover the entire folded portion of the fixing structure 500. In some embodiments, the interface-facing area of ​​the body 502 includes at least a portion having adhesive material. In some embodiments, the entire body 502 includes adhesive material. The tube retention adhesive 508 may adhere to the adhesive material on the body 502 to facilitate inter-body bonding. Figure 13B As shown, the body 502 includes a fixation element 510 on the patient-facing portion of the body 502. The fixation element 510 engages with one of the attachment structures 216A, 216B (see elsewhere in this disclosure). Figure 3 (As described). In the illustrated configuration, the fixing element 510 includes a 'hook' pad for engaging with one of the attachment structures 216A, 216B to achieve a 'hook-and-loop' connection.

[0142] The body 502 includes a pair of separable extensions 506A and 506B. In the illustrated configuration, the separable extensions 506A and 506B are formed of the same material as the body 502. In some configurations, the separable extensions 506A and 506B may be formed of a different material than the body 502. The separable extensions 506A and 506B are linked to the body 502 at a first edge 503A and a second edge 503B. The separable extensions 506A and 506B are linked to the body 502 through perforated sections 504A and 504B. The perforated sections 504A and 504B can be torn open to allow the separable extensions 506A and 506B to be separated from the body 502. In some configurations, a single set of perforated sections 504A and 504B links the body 502 to the separable extensions 506A and 506B. In some configurations, multiple sets of perforated sections 504A, 504B (e.g., two, three, or four sets) can link the body 502 to the separable extensions 506A, 506B. The separable extensions 506A, 506B secure or enclose the tube 400.

[0143] Figure 14A and 14B Showing Figure 13A and 13B The fixation structure 500. A close-up of the patient's face, including the nose (N) and mouth (M), is shown. Focused on Figure 14A and Figure 14BOn the left side, for use with the fixation structure 500, one of the separable extensions 506A can be removed from the body 502. The tube 400 can be placed on the body 502 and the remaining separable extension 506B. The side of the body 502 including the tube retention adhesive 508 can be folded onto the tube 400 together with the remaining separable extension 506B to secure the tube 400 to the body 502. When folded, the fixation element 510 of the body 502 is exposed, thereby allowing the fixation element 510 to be connected to one of the attachment structures 216A, 216B of the patient interface 200.

[0144] Focus Figure 14A and Figure 14B On the right side, the fixation structure 500 (or a second fixation structure) can be used on the other side of the face. In this case, the separable extension 506B can be removed. As described above, the tube 400 is positioned on the body 502 such that the tube retention adhesive 508 can be folded onto the tube 400 and adhered to the body 502, thereby holding the tube 400 in place. The tube retention adhesive 508 can be positioned such that it is close to the eye or away from the eye before folding. When folded, the fixation element 510 of the fixation structure 500 is exposed so that it can be coupled to one of the attachment structures 216A, 216B of the patient interface 200. Although the other fixation structure shown is used to retain the tube 400, in other configurations, the tube may not be used with the other fixation structure or multiple tubes may be used with it.

[0145] In the illustrated embodiment, the tube retention adhesive 508 portion of the fixation structure 500 is positioned away from the patient's eye area to reduce the risk of it loosening during use and opening onto or near the eye, thereby causing discomfort to the patient.

[0146] Figure 15A and 15B An exemplary configuration of a fixing structure assembly 600 for fixing tube 400 is shown. The fixing structure assembly 600 includes a body 602, a first intermediate region 605A and a second intermediate region 605B, perforated sections 606A1, 606A2, 606B1, and 606B2, and a first separable extension 604A and a second separable extension 604B. Figure 15A The interface-facing area of ​​the body 602 of the fixed structure component 600 is shown. Figure 15B The patient-facing area of ​​body 602 is shown. Body 602 is formed of or includes an adhesive material for adhesion to the patient's face. In the shown configuration, body 602 is formed of or includes a hydrocolloid-based adhesive material. Figure 15AAs shown, the sides of the separable extensions 604A and 604B corresponding to the interface-facing area of ​​the body 602 include adhesive portions 608A and 608B. Figure 15B As shown, the sides of the separable extensions 604A and 604B corresponding to the patient-facing area of ​​the body 602 include fixation elements 610A and 610B. Fixation elements 610A and 610B engage with attachment structures 216A and 216B (see elsewhere in this disclosure). Figure 3 (As described) for securing the patient interface 200 to the face. In the illustrated configuration, the securing elements 610A, 610B include 'hook' pads for engaging with attachment structures 216A, 216B to achieve a 'hook-and-loop' connection.

[0147] Figure 15C Showing Figure 15B The fixing structure assembly is located along the cross-section of line AA. As shown, the fixing structure assembly 600 includes an interface-facing region 603 and a patient-facing region 605. The interface-facing region 603 includes a portion of the body 602 between separable extensions 604A and 604B. Figure 15C The detachable extensions 604A and 604B are indicated by imaginary dashed lines that separate them from the body 602. The detachable extensions 604A and 604B may include adhesive material. The patient-facing region 605 includes fixing elements 610A and 610B, a portion of the body 602 located therebetween. The patient-facing region 605 includes adhesive material. In some embodiments, the interface-facing region 603 and the patient-facing region 605 may be separated by a membrane 607.

[0148] In the illustrated embodiment, the portion of body 602 in the patient-facing region 605 has a thickness t1 greater than the thickness t2 of the fixing elements 610A, 610B. In some embodiments, the portion of body 602 in the interface-facing region 603 has a thickness t3 that is substantially the same as the thickness t1 of the portion of body 602 in the patient-facing region 605. Thicknesses t1, t2, and t3 can be varied to accommodate different materials and / or applications. For example, thickness t2 may be greater than thicknesses t1 and / or t3 in some embodiments. In some embodiments, thickness t1 may be different from thickness t3. In some embodiments, body 602 in the interface-facing region 603 includes an adhesive material. As previously described, one of the separable extensions 604A, 604B can be folded such that the adhesive material attaches one of the separable extensions 604A, 604B to body 602 in the interface-facing region 603. This exposes one of the fixation elements 610A and 610B on the interface-facing area 603, allowing it to be coupled to the patient interface 200. Another separable extension can be removed via perforated sections 606B1 and 606B2 as described above and attached to the patient's face via the adhesive material, thus exposing the fixation element to facilitate coupling between the separable extension and the patient interface 200.

[0149] Figure 16A and 16B Showing Figure 15A and 15BThe fixation structure assembly 600 is shown. A close-up of a patient's face, including a nose (N) and a mouth (M), is shown. The fixation structure assembly 600 can be torn along a tear line T, thereby separating one of the separable extensions 604B along perforated sections 606B1 and / or 606B2. In the illustrated embodiment, a pair of perforated sections 606B1, 606B2 links the body 602 to one of the separable extensions 604A, 604B. In some embodiments, only a single perforated section 606B1 or 606B2 links the body 602 to one of the separable extensions 604A, 604B. In some embodiments, multiple perforated sections 606B1 and / or 606B2 (e.g., but not limited to two, three, or four perforated sections) can link the body 602 to one of the separable extensions 604A, 604B. In some embodiments, the area between the multiple perforated segments 606B1, 606B2 may include an adhesive material. The body 602 and the separable extension 604A still attached to the body 602 can be placed on one side of the face, and the detached separable extension 604B can be adhered to the other side of the face using adhesive portion 608B, thus exposing the fixation element 610B of the detached separable extension 604B. The tube 400 can be placed on the body 602, and the separable extension 604A attached to the body 602 can be folded to cover the tube 400. The fixation elements 610A, 610B can then be exposed and engaged with the attachment structures 216A, 216B of the patient interface 200, as shown in [reference needed]. Figure 3 As described, it is used to secure the patient interface 200 to the face.

[0150] In some embodiments (and as shown) Figures 16A-16B As shown), the tube 400 can be positioned in or adjacent to a perforated area (e.g., the first intermediate area 605A). This facilitates quick and easy removal of the fastening structure assembly 600 from the tube 400 by tearing along the perforated sections 606B1 and / or 606B2. Therefore, the tube 400 does not necessarily have to be removed when the fastening structure is removed, and thus the care provider is not required to reinsert the tube 400 after removing the fastening structure assembly 600, thereby reducing the number of steps required. Positioning the tube 400 in or near the perforated area can facilitate folding and / or adhesion of the fastening structure assembly 600 to itself. For example, this can facilitate folding the separable extension 604A onto the body 602. It should be understood that, in Figure 12A-12B The embodiments shown can also facilitate positioning the tube 400 at or near the perforation area 330A.

[0151] See Figure 17AThis illustrates another embodiment of the fixing structure 700. The fixing structure 700 may include one or more features of the previously described fixing structure, such as those described above. Figure 15A-16B The described fixation structure assembly 600. As shown, the fixation structure 700 includes a body 702 and a first edge 704 and a second edge 706. Similar to the fixation structure described above, the fixation structure 700 may include a fixation element 710 (not shown). The fixation element 710 engages with one of the attachment structures 216A, 216B to secure the patient interface 200 to the face. In some embodiments, the fixation element 710 includes a hook pad for releasable attachment to a loop pad of one of the attachment structures 216A, 216B to form a hook-and-loop connection.

[0152] The fixed structure 700 may include one or more of the separable extensions 732A and 732B. In some configurations, the separable extensions 732A and 732B are formed of the same material as the body 702. In some configurations, the separable extensions 732A and 732B are formed of a different material than the body 702. The separable extensions 732A and 732B may be substantially airfoil-shaped. The separable extensions 732A and 732B may be at least partially linked to the body 702 via multiple rows of perforated sections 730A and 730B. The perforated sections 730A and 730B may be torn open to allow the separable extensions 732A and 732B to be separated from the body 702. In some configurations, one of the perforated sections 730A and 730B may link the body 702 to a corresponding one of the separable extensions 732A and 732B. In some configurations, multiple perforated sections 730A, 730B (e.g., two, three, or four perforated sections) can link the body 702 to the separable extensions 732A, 732B.

[0153] The arrangement of the multiple rows of perforated sections 730A, 730B can be modified. For example, these rows of perforated sections 730A, 730B can make the separable extensions 732A, 732B easy for an easy user (e.g., a nurse or other caregiver) to tear open from one side, while being difficult for the patient to tear open. This can prevent, deter, or make it difficult for the patient to remove the fixation structure 700 (and the attached tube 400) from the patient's face. Figure 17B In the configuration of the fixing structure 700 shown, these structures begin with perforations on the side of the first edge 704 and end with non-perforations on the side of the second edge 706. This facilitates tearing the fixing structure 700 from the first edge 704 towards the second edge 706, and / or prevents or makes it difficult to tear the fixing structure 700 from the second edge 706 towards the first edge 704. In some configurations, such as... Figure 17CAs shown, these perforated sections 730A and 730B begin and end with non-perforated portions. In some variations, these perforated sections 730A and 730B begin and end with perforated portions.

[0154] In some embodiments, the fixing structure 700 is configured such that the perforated sections 730A, 730B are more easily activated, for example, by tearing or pulling, in one direction than in the other. For example, in Figure 17D In the embodiments shown, the perforated sections 730A and 730B include hooked, curved, or angled perforations. For example, the perforated sections 730A and 730B may generally be shaped like the letter "J" or "L". In some embodiments, when pulled from the second edge 706 toward the first edge 704, the gap between the current perforation and the next perforation is larger than when pulled from the first edge 704 toward the second edge 706. In some embodiments, such as Figure 17E As shown, each of the perforated sections 730A and 730B includes a first leg and a second leg, the angle between the first leg and the second leg being at least about 91°, at least about 100°, at least about 110°, at least about 120°, at least about 130°, at least about 145°, or at least about 160°. In some embodiments, the angle between the first leg and the second leg is at most about 89°, at most about 80°, at most about 70°, at most about 60°, at most about 45°, or at most about 30°. In some embodiments, the angle between the first leg and the second leg is a right angle. Other angles are contemplated. In some implementations, the first leg and the second leg include straight perforations.

[0155] See Figure 18 This illustrates another embodiment of the fixation structure 800. The fixation structure 800 may include one or more of the features of the fixation structures described above. As shown, the fixation structure 800 includes a body 802 and a first edge 804 and a second edge 806. Similar to the fixation structures described above, the fixation structure 800 may include fixation elements 810A and 810B. Fixation elements 810A and 810B may engage with attachment structures 216A and 216B to secure the patient interface 200 to the face. In some embodiments, fixation elements 810A and 810B include hook pads for releasable attachment to loop pads of attachment structures 216A and 216B to form a hook-and-loop connection.

[0156] The fixed structure 800 may include one or more of the separable extensions 832A and 832B. In some configurations, the separable extensions 832A and 832B are formed of the same material as the body 802. In some configurations, the separable extensions 832A and 832B are formed of a different material than the body 802. The separable extensions 832A and 832B may be substantially airfoil-shaped. The separable extensions 832A and 832B may be at least partially linked to the body 802 via multiple rows of perforated sections 830A and 830B. The perforated sections 830A and 830B may be torn open to allow the separable extensions 832A and 832B to be separated from the body 802. In some configurations, one of the perforated sections 830A and 830B may link the body 802 to a corresponding one of the separable extensions 832A and 832B. In some configurations, multiple perforated sections 830A, 830B (e.g., two, three, or four perforated sections) can link the body 802 to the separable extensions 832A, 832B.

[0157] Some embodiments may facilitate maintaining tube 400 in the patient's body. This can be helpful because, for example, nasogastric or nasojejunal tubes are typically sterile components and are therefore usually discarded and replaced after removal from the patient. By maintaining tube 400 in the patient's body, tube 400 can continue to be used, which can reduce waste and the workload associated with caring for the patient. Moreover, maintaining tube 400 in the patient's body can reduce or avoid the difficulties and discomfort associated with securing a nasogastric or nasojejunal tube, typically inserted through the nasal passage and throat and into the stomach. Insertion of a nasogastric or nasojejunal tube can be particularly challenging and uncomfortable for infants and newborns. In some embodiments, tube 400 may be positioned in or near the perforation area, which can facilitate the disassembly of some or all of the fixation structure components 600 from tube 400 without requiring removal of tube 400 from the patient. For example, a user (e.g., a nurse) can pull the detachable extension 604A or the body 602 to create a break around the perforation area, thereby allowing the detachable extension 604A and / or the body 602 to separate from the tube 400 while still allowing the tube 400 to remain in place (in the patient's nose). Therefore, some embodiments can provide the ability to quickly and efficiently remove some or all of the fixation components 600 from the tube 400 while allowing the tube 400 to remain in the nose, thereby making it more comfortable for the patient, easier and faster for the caregiver, and / or reducing the use of nasogastric and nasojejunal tubes. All of the above applies to the use of orogastric and orojejunal tubes inserted into a patient's mouth.

[0158] Some embodiments have an increased area near the fixing element 610B (see [link]). Figure 16BThis enlarged area can serve as a support portion 601, such as a splice or other protrusion. The support portion 601 allows a user (e.g., a nurse) to engage or press it with their fingers or instruments. This can assist in disengaging the fixation structure assembly 600 from the tube 400 and / or the patient interface 200. In some variations, the support portion 601 can assist in removing the tube 400 from the patient. In some embodiments, the support portion 601 can help stabilize the fixation structure assembly 600 and / or reduce damage to the fixation structure assembly 600 on the patient's face.

[0159] In some embodiments, the fixing structure assembly 600 includes one or more backing strips (not shown). These backing strips may include creases to allow easy removal of the backing strips to expose the fixing structure assembly 600 for use and / or to protect adhesion / stickiness when the fixing structure assembly 600 is not in use.

[0160] Unless the context clearly requires otherwise, the terms “comprise”, “comprising”, etc., used throughout this specification and claims shall be interpreted in an open sense (as opposed to a closed or exhaustive sense), that is, meaning “including but not limited to”.

[0161] In the above description, wherever reference has been made to an integral or component having a known equivalent thereof, such integral or component is incorporated herein as if presented separately.

[0162] The disclosed methods, apparatus, and systems can also be broadly defined to include any part, element, or feature individually or collectively referred to or indicated herein, as well as any or all combinations of two or more of said parts, elements, or features. Furthermore, this disclosure includes combinations of these different characteristics, aspects, methods, properties, features, qualities, attributes, elements, etc., of these different embodiments. For example, any particular characteristic, aspect, method, property, feature, quality, attribute, element, or similar element associated with one embodiment may be used in connection with any other embodiment set forth herein.

[0163] Any reference to prior art in this specification is not and should not be construed as an admission or in any way implying that the prior art constitutes part of common general knowledge in the relevant field in any country of the world.

[0164] The degree language used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein, means a value, quantity, or characteristic that is close to the stated value, quantity, or characteristic while still performing the desired function or achieving the desired result. For example, the terms “generally parallel” and “substantially parallel” refer to a value, quantity, or characteristic that may deviate from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or other values, quantities, or characteristics.

[0165] Some embodiments have been described with reference to the accompanying drawings. These drawings are drawn to scale, but such scale should not be limiting. Dimensions and proportions other than those shown are considered and fall within the scope of this disclosure. Distances, angles, shapes, etc., are merely illustrative and do not necessarily have a precise relationship with the actual size and layout of the illustrated device. Components may be added, deleted, and / or rearranged.

[0166] Although this disclosure has been described with respect to specific embodiments, other embodiments will be apparent to those skilled in the art as falling within the scope of this disclosure. Therefore, various changes and modifications can be made without departing from the spirit and scope of this disclosure. For example, various different components can be repositioned as desired. Furthermore, not all of these features, aspects, and advantages are necessary for practicing this disclosure. Therefore, the scope of this disclosure is intended to be defined solely by the following claims.

Claims

1. A fixing structure for securing a patient interface to a patient's face, the fixing structure comprising: The body includes a first edge, a second edge, and opposing third and fourth edges extending between the first and second edges, the first edge being configured to face the patient's nose or mouth, and the second edge being configured to face away from the patient's nose or mouth; wherein the body includes opposing first and second regions, the first region including an adhesive to be adhered to the patient's face, and the second region being an interface-facing region. A first extension, which is linked to the body at the third edge of the body and has a first side and an opposite second side, is configured to retain the tube by folding the first extension onto the tube and attaching the second side of the first extension to the interface-facing area of ​​the body. The first side of the first extension includes a fastening element configured to releasably attach to a first complementary fastener of the patient interface, and The third edge includes a curve that is at least partially concave relative to the third edge; The curves described therein correspond substantially to the outline of the eyes; The fixing structure further includes a second extension that connects to the body at the fourth edge of the body, wherein the fourth edge includes a curve that is at least partially concave relative to the fourth edge. The curve of the fourth edge substantially corresponds to the outline of the eye. The second extension has a first side and an opposite second side, and is configured to secure the tube by folding the second extension onto the tube and adhering the second side of the second extension to the interface-facing area of ​​the body; and The first side of the second extension includes a fastening element configured to releasably attach to the patient interface on a second complementary fastener.

2. The fixing structure as described in claim 1, wherein, The third edge and / or the fourth edge extend further from the midline or central portion of the body at the portions of the third edge and the fourth edge that are closer to the first edge and the second edge.

3. The fixing structure as described in claim 1 or 2, wherein, The portions of the third and fourth edges closer to the second edge extend further from the centerline or central portion of the body than the portions of the third and fourth edges closer to the first edge.

4. The fixing structure as described in claim 1 or 2, wherein, The first extension is separable.

5. The fixing structure as described in claim 1 or 2, wherein, The first extension includes a weak section.

6. The fixing structure as described in claim 1 or 2, wherein, The first extension is connected to the body via a weak connection.

7. The fixing structure as described in claim 1 or 2, wherein, The first extension is connected to the third edge of the body via the middle portion.

8. The fixing structure as described in claim 7, wherein, The intermediate portion is configured to receive the tube.

9. The fixing structure as described in claim 7, wherein, The intermediate portion includes a perforated portion configured to allow the first extension to separate from the body.

10. The fixing structure as described in claim 1 or 2, wherein, The first extension is configured to fold onto the body about a pivot axis such that the first extension substantially overlaps with and adheres to the body.

11. The fixing structure as described in claim 1 or 2, wherein, The fixing structure includes adhesive and non-adhesive parts.

12. The fixing structure as described in claim 11, wherein, Only one of the body and the first extension includes an adhesive portion.

13. The fixing structure as described in claim 1 or 2, wherein, The fastening element includes a hook pad for releasable attachment to a ring pad of the first complementary fastener.

14. The fixing structure as described in claim 1 or 2, wherein, The tube in question is a feeding tube.

15. The fixing structure as described in claim 6, wherein, The first extension is connected to the body via a perforated section.

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