Devices, systems, and methods for securing a therapeutic member

Abstract

Disclosed herein are devices and related systems and methods for securing elongated treatment members to a patient. In some embodiments, a device is configured to secure a medical device comprising a nasally or orally inserted elongated treatment member to a patient's face. The device can comprise one or more portions configured to adhere to one or more portions of the patient's face and one or more portions configured to secure a length of the extracorporeal portion of the elongated treatment member to the device. The device can comprise an adhesive bond with the patient's skin and the adhesive bond can have an adhesive bond strength sufficient to prevent the patient from prematurely removing the device or treatment member. A release agent can be applied to the device to reduce the adhesive bond strength between the device and the patient's skin such that the device can be removed from the patient's face without causing significant discomfort to the patient.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 198,911, filed November 20, 2020, entitled “DEVICES, SYSTEMS, AND METHODS FOR SECURING TREATMENT MEMBERS,” which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to apparatus, systems, and methods for securing therapeutic components to a patient. Specific embodiments include apparatus for securing the external portion of a transnasal, elongated therapeutic component (e.g., a nasogastric tube or nasoenteric tube) to a patient's face.

[0004] background

[0005] To maintain nutrition and hydration in patients with swallowing difficulties, especially in a hospital setting, standard practice is to insert a nasogastric feeding tube to allow for safe, direct delivery of substances to the stomach. These tubes can remain in place for up to 4 to 6 weeks. After this period, the tubes are removed if the patient's swallowing has improved sufficiently, or if the patient's swallowing has not improved, the tubes are removed and replaced with a gastrostomy tube more suitable for long-term feeding.

[0006] Swallowing dysfunction following stroke, trauma, infection, or brain injury caused by prolonged mechanical ventilation often necessitates enteral nutrition via a nasogastric tube. Ensuring patients receive adequate nutrition immediately after injury or ventilation is crucial for maximizing recovery and rehabilitation.

[0007] It is not uncommon for patients to feel confused and / or resist, especially after brain injury. While nasogastric feeding tubes are effective in supporting nutritional needs, they are often uncomfortable for patients. Consequently, patients frequently attempt to pull out the feeding tube. Changing and maintaining the feeding tube can be labor-intensive and uncomfortable for the patient.

[0008] To address the aforementioned issues, low-adhesion medical tape 100 is typically used to secure the nasogastric tube 101 to the patient, such as... Figure 1 As shown. Medical tape must be low-tack so that it can be removed subsequently with minimal pain and without damaging the patient's skin. This latter consideration is particularly important for certain patient groups known to have fragile skin, such as elderly patients. However, the low-adhesion properties of low-tack tape allow for relatively easy and less uncomfortable removal by the patient. Therefore, low-tack medical tape is insufficient to prevent the removal of nasogastric tubes.

[0009] Another device used to secure a nasogastric tube is a nasal bridle 200, such as... Figure 2 As shown. The annular portion of the restraint 200 extends through one nostril, around the nasal septum, and returns through the other nostril. The ends of the ring extend out of the nostril and are secured together at a position outside the patient's nasal cavity. For example, as... Figure 2 As shown, the nasal restraint 200 may include a clip positioned outside the patient's nasal cavity, and the clip is configured to retain the end of a ring of the restraint 200. The end of the ring may be secured to a nasogastric tube, such that the nasogastric tube is indirectly secured to the patient's nasal septum via the ring. While the nasal restraint 200 is associated with a lower tube displacement rate than medical tape, restraint insertion is traumatic for the patient, and the restraint itself is extremely uncomfortable once installed. Furthermore, patients attempting to remove the feeding tube 201 secured with the nasal restraint 200 may tear their nasal septum in the process. For example, some patients with brain injuries have impaired sensory systems, and these patients may not be aware that pulling on the nasal restraint and / or the feeding tube is compressing their nasal septum, potentially tearing it.

[0010] In view of the above, there is a need for devices, systems, and methods for holding and securing nasally inserted catheters or other long therapeutic components in a manner that is minimally invasive to patients, safe for healthcare workers, and easy to use.

[0011] Overview

[0012] This technology relates to devices, systems, and methods for securing therapeutic components relative to a patient. In certain embodiments, this technology includes a device configured to secure the external portion of a transnasal or transoral elongated therapeutic component (e.g., a catheter, feeding tube, etc.) to the patient's face to prevent or substantially inhibit displacement or removal of the device and associated therapeutic component. For example, several embodiments of this disclosure are configured to secure a transnasal enteral feeding tube (e.g., a nasoenteric tube or nasogastric tube) to the patient's face. For example, according to various aspects described below (including references) Figures 1-7 The subject matter techniques are described using the following terms. For convenience, various examples of subject matter techniques are described using numbered clauses (1, 2, 3, etc.). These are provided as examples and do not limit the subject matter techniques.

[0013] 1. A device configured to fix the position of an external portion of an elongated therapeutic member, the elongated therapeutic member being inserted into a patient's body cavity, the device comprising:

[0014] The first part is configured to adhere to the patient's nose;

[0015] The second portion extends from the first portion along the longitudinal dimension of the device, wherein the second portion is configured to adhere to the patient's cheek; and

[0016] The third portion extends laterally away from the second portion along the longitudinal dimension of the device, wherein the third portion is configured to fold over a section of the external portion of the elongated treatment member and be secured to the device, such that the elongated treatment member is secured to the device.

[0017] Each of the first portion and the second portion includes an adhesive, and

[0018] Each of the first part, the second part, and the third part includes an integrated structure.

[0019] 2. The device according to Clause 1, wherein the adhesive has sufficient adhesive strength to prevent the device from being mechanically removed from the patient's face without discomfort.

[0020] 3. The device according to Clause 1 or Clause 2, wherein when the release agent is applied to the device, the release agent reduces the adhesive strength of the adhesive, thereby enabling the device to be mechanically removed from the patient's face.

[0021] 4. The device according to any one of clauses 1 to 3, wherein the elongated treatment component comprises a nasogastric tube.

[0022] 5. The apparatus according to any one of clauses 1 to 4 further includes a first material and a second material, wherein the first material and the second material extend together with the first portion and the second portion, wherein the adhesive is positioned between the first material and the second material.

[0023] 6. The device according to Clause 5, wherein the first material is configured to face away from the patient's face when the device is adhered to the patient's face.

[0024] 7. The device according to Clause 5 or Clause 6, wherein the second material is configured to be removed before the device is adhered to the patient's face.

[0025] 8. The apparatus according to any one of clauses 5 to 7, wherein the first material comprises a breathable material and the second material comprises a liner.

[0026] 9. The apparatus according to any one of clauses 1 to 8, wherein:

[0027] The third portion includes a first side and a second side opposite the first side along the thickness of the third portion, and the second side is positioned near the patient's face when the first and second portions are adhered to the patient's face and the third portion is not yet folded onto the elongated treatment member.

[0028] The device further includes a removable element and an adhesive element positioned on the first side of the third portion, wherein the adhesive element is positioned between the removable element and the first side.

[0029] 10. The apparatus according to Clause 9, wherein the removable element is a backing paper configured to be removed from the apparatus to expose the adhesive element.

[0030] 11. The apparatus according to Clause 9 or Clause 10, wherein the adhesive element comprises an absorbent material.

[0031] 12. The device according to claims 1 to 11, wherein the first portion includes an elastic member configured to conform the first portion to the patient's nose.

[0032] 13. The device according to any one of clauses 1 to 12, wherein the second portion of the device includes one or more openings configured to receive the elongated treatment member such that the elongated treatment member extends along the longitudinal dimension of the device.

[0033] 14. The device according to any one of clauses 1 to 13, further comprising a channel extending along at least a portion of the first portion and at least a portion of the second portion, wherein the portion of the device defining the channel does not include the adhesive, and wherein the channel is configured to receive a release agent through the channel to enable the device to be mechanically detached from the patient's skin.

[0034] 15. The apparatus according to Clause 14 further includes a valve fluidly coupled to the channel and configured to receive the release agent from an external source.

[0035] 16. The apparatus according to any one of clauses 1 to 15, wherein the adhesive is a high-viscosity adhesive.

[0036] 17. The device according to any one of clauses 1 to 16, wherein the first portion has a sufficiently large surface area such that the first portion and the second portion are configured to prevent the device from being mechanically removed from the patient's face without discomfort.

[0037] 18. A device configured to attach an external portion of an elongated therapeutic member to a patient's face, the elongated therapeutic member being inserted into a patient's body cavity, the device comprising:

[0038] The nasal portion includes a first surface containing an adhesive and a second surface opposite the first surface along the thickness of the nasal portion, the first surface of the nasal portion being configured to adhere to the bridge of the patient's nose, wherein the nasal portion has a first end configured to adhere to a first alar region of the patient and a second end configured to adhere to a second alar region of the patient.

[0039] A facial portion, the facial portion including a first surface containing an adhesive and a second surface opposite the first surface along the thickness of the facial portion, the first surface of the facial portion being configured to adhere to the patient's cheek, wherein the facial portion has a first end at the nasal portion and a second end spaced apart from the first end along a first direction; and

[0040] The fixing portion includes a first surface and a second surface opposite to the first surface along the thickness of the fixing portion, wherein the fixing portion has a first end on the face portion and a second end spaced apart from the first end along a second direction, the second direction being configured at an angle relative to the first direction.

[0041] The fixing portion includes a first state and a second state. In the first state, the first surface is configured to be positioned near the patient's face. In the second state, the fixing portion is configured to fold onto the external portion of the elongated treatment member, such that the second surface is fixed to the device, and the position of the external portion of the elongated treatment member relative to the device is fixed.

[0042] The second surface of the nose portion, the second surface of the face portion, and the first surface of the fixing portion constitute an integral structure.

[0043] 19. The device according to Clause 18, wherein, when the nasal portion is adhered to the patient's bridge of the nose and the facial portion is adhered to the patient's cheek, the adhesive bonding strength between the device and the patient's face prevents the device from mechanically separating from the patient's face without causing discomfort to the patient.

[0044] 20. The device according to Clause 19, wherein when the release agent is applied to the device, the adhesive bond strength between the device and the patient's face is reduced, such that the device can be mechanically separated from the patient's face without causing discomfort to the patient.

[0045] 21. The device according to any one of clauses 18 to 20, wherein each of the second surface of the nasal portion, the second surface of the facial portion, and the first surface of the fixing portion comprises a breathable material.

[0046] 22. The device according to any one of clauses 18 to 21, wherein the first direction substantially corresponds to the longitudinal dimension of the device.

[0047] 23. The device according to any one of clauses 18 to 21, wherein, when the device is adhered to the patient’s face, the first direction extends from the first end to the second end in a substantially downward direction.

[0048] 24. The device according to any one of clauses 18 to 23, wherein the elongated therapeutic component is an electrical stimulation device.

[0049] 25. The device according to any one of clauses 18 to 24, wherein at least one of the first surface of the nasal portion, the first surface of the facial portion, or the second surface of the fixing portion includes a backing material configured to prevent the device from being adhered to the patient's face until the backing material is removed.

[0050] 26. The device according to any one of clauses 18 to 25, wherein at least one of the first surface of the nose portion, the first surface of the face portion, or the second surface of the fixing portion comprises an absorbent material carrying the adhesive.

[0051] 27. The device according to any one of clauses 18 to 26, wherein the nasal portion includes an elastic member configured to conform the first portion to the bridge of the patient's nose.

[0052] 28. The device according to any one of claims 18 to 27, wherein the facial portion of the device includes one or more openings configured to receive the elongated treatment member such that, when the device is adhered to the face of the patient, the elongated treatment member extends laterally along the patient's cheek.

[0053] 29. The device according to any one of clauses 18 to 28 further includes a channel extending along the perimeter of the first portion and the second portion, wherein the perimeter of the first portion and the second portion does not include the adhesive, and wherein the channel is configured to receive a release agent through the channel so that the device can be mechanically detached from the patient's skin.

[0054] 30. The apparatus according to Clause 29 further includes a port fluidly coupled to the channel and configured to receive the release agent from an external source.

[0055] 31. A device configured to fix the position of the proximal portion of an elongated therapeutic member inserted into a patient's body cavity, the device comprising:

[0056] A first wide surface, the first wide surface including a first shape, the first shape including a first portion, a second portion, and a third portion; and

[0057] A second wide surface, which is opposite to the first wide surface along the thickness of the device, includes a second shape comprising a first portion, a second portion, and a third portion, wherein the second shape is substantially identical to the first shape.

[0058] The first and second portions of the first wide surface and the third portion of the second wide surface include absorbent material, and an adhesive is disposed on the absorbent material.

[0059] The third portion of the first wide surface and the first and second portions of the second wide surface include breathable material.

[0060] The first and second portions of the first wide surface are configured to adhere to the patient's nose and the patient's face, respectively.

[0061] The third portion of the second wide surface is configured to adhere to the proximal portion of the elongated therapeutic member.

[0062] 32. The device according to clause 31, wherein the first portion and the second portion of the first wide surface have a sufficiently large surface area to prevent the device from being prematurely removed from the patient's face.

[0063] 33. The device according to clause 31 or clause 32, wherein the device is configured to receive a solvent configured to dissolve the adhesive, such that the device can be removed from the patient's face without causing discomfort to the patient.

[0064] 34. The device according to any one of clauses 31 to 33, wherein the breathable material is opaque and the adhesive is photosensitive.

[0065] 35. The device according to clause 34, wherein the breathable material is configured to be removed from the device such that the adhesive is exposed to light and dissolves, thereby enabling the device to be removed from the patient's face without causing discomfort to the patient.

[0066] 36. A method for securing an external portion of an elongated therapeutic component inserted into a patient's body cavity to a device and securing the device to the patient's face, the method comprising:

[0067] The nasal portion of the device is adhered to the patient's nose;

[0068] The first region of the external portion of the elongated treatment component is positioned near the fixed portion of the device;

[0069] The fixing portion of the device is folded over the first region of the external portion of the elongated treatment member, and the fixing portion is adhered to the device;

[0070] Positioning a second region of the external portion of the elongated treatment member within an opening defined by the facial portion of the device; and

[0071] The facial portion of the device is adhered to the patient's cheek.

[0072] 37. The method according to Clause 36, wherein the nasal portion is adhered to the patient's nose and the facial portion is adhered to the patient's cheek, wherein the adhesive bonding strength is sufficiently high to prevent the device from being mechanically removed from the patient's face.

[0073] 38. A method for removing a device adhered to a patient's face via an adhesive, the method comprising:

[0074] The valve that delivers the release agent from an external source to the device;

[0075] The release agent is delivered from the valve to a channel of the device, wherein the channel extends along at least a portion of the device, the portion of the device being located at or near the perimeter of the device;

[0076] Reduce the adhesive bond strength between the device and the patient's face at at least one location near the channel; and

[0077] A force is applied to the device to mechanically separate it from the patient's face.

[0078] 39. A device configured to fix the external portion of an elongated therapeutic member inserted into a patient's body cavity in position relative to the patient's face, the device comprising:

[0079] The main body includes:

[0080] The first part is configured to adhere to the patient's nose;

[0081] The second portion extends from and is continuous with the first portion along the longitudinal dimension of the device, wherein the second portion is configured to adhere to the patient's cheek and / or jaw; and

[0082] A retaining element, located at the body, is configured to detachably couple the external portion of the elongated therapeutic member to the device.

[0083] Each of the first and second parts comprises a highly viscous adhesive.

[0084] 40. The apparatus according to clause 39, wherein the retaining element is integral with the body.

[0085] 41. The device according to clause 39, wherein the retaining element is a separate element fastened to the body.

[0086] 42. A device configured to fix the external portion of an elongated therapeutic member inserted into a patient's body cavity in a fixed position, the device comprising:

[0087] A first material, the first material comprising an adhesive configured to adhere the device to the patient’s skin;

[0088] A second material is located on the first material, and the second material has a perimeter and a region defined by the perimeter;

[0089] Multiple interconnect channels, the multiple interconnect channels being located between the first material and the second material; and

[0090] The passage port is fluidly coupled to the channel.

[0091] Wherein, when the device is adhered to the patient’s skin: (a) the port is configured to provide a fluid passage to the channel, and (b) delivery of a release agent through the port to the channel causes the release agent to be distributed on and / or along at least some areas of the second material, thereby neutralizing the adhesive and enabling the device to be removed from the patient’s skin. Brief description of the attached diagram

[0093] Many aspects of this disclosure can be better understood with reference to the following accompanying drawings. The components in the drawings are not necessarily drawn to scale. Rather, the focus is on clearly illustrating the principles of this disclosure.

[0094] Figure 1 The prior art medical tape is described as being configured to fix an elongated therapeutic component.

[0095] Figure 2 A prior art nasal restraint device configured as a fixed elongated treatment component is described.

[0096] Figure 3 This is a top view of a device configured to secure an elongated therapeutic component to a patient, according to several embodiments of the present technology.

[0097] Figure 4 yes Figure 3 An exploded view of the apparatus shown.

[0098] Figure 5 Several embodiments of the present technology are depicted, illustrating devices configured to secure an elongated therapeutic member to a patient. Figure 5 In the image, the device is shown adhering to the patient's face.

[0099] Figure 6 Several embodiments of the present technology are depicted, which are configured to attach an elongated therapeutic component to a patient and an external source of a release agent.

[0100] Figure 7 Several embodiments of the present technology are depicted, illustrating devices configured to secure an elongated therapeutic member to a patient. Figure 7 In the image, the device is shown adhering to the patient's face.

[0101] Detailed description

[0102] The device disclosed herein is configured to address the limitations associated with conventional methods of securing long therapeutic components that have been partially inserted into a patient's body cavity. In some embodiments, the technology includes a device (e.g., a medical dressing) configured to secure a long therapeutic component (e.g., a nasogastric tube, catheter, etc.) to a patient's face. The device may be configured to adhere to the patient's face via an adhesive. According to several embodiments, the device has a large surface area and is configured to adhere to the patient's face with high adhesive bond strength. These features of the device, individually or in combination, result in the device adhering firmly to the patient's face, preventing the patient from removing the device without discomfort. Therefore, the device is configured to inhibit premature removal or displacement of the therapeutic component and / or device by a resisting and / or confused patient. When a clinician determines that the device and therapeutic component should be removed, the device is configured to detach from the patient's face without discomfort by employing a selective release mechanism to deactivate and / or weaken the adhesive bond between the device and the patient's skin. For example, a clinician may apply a solvent to the device configured to dissolve the adhesive. In some embodiments, the adhesive is photosensitive, and the clinician may expose the adhesive to light to degrade the adhesive.

[0103] Figure 3 and Figure 4 These are, respectively, a top view and an exploded view of the fixation device 300 (or “device 300”) of the present technology, which is configured to fix the external portion of an elongated treatment member inserted through the nose relative to the patient’s face. Figure 5 A device similar to device 300 is depicted, which is adhered to a patient's face and secures a treatment component 401 thereto. It should be understood that device 300 can be used to secure various types of treatment devices to a patient. Such treatment devices can be inserted through the nasal cavity and / or mouth (e.g., feeding tubes, stimulating devices, endoscopes, etc.), through the vascular system, and / or subcutaneously. Device 300 or one or more portions thereof may include a large surface area configured to adhere to the patient's face. Device 300 may also include a highly adhesive adhesive for bonding to the patient's skin. As discussed herein, when device 300 adheres to the patient's skin, the large surface area and / or adhesive strength create significant resistance to the removal of device 300, a resistance designed to cause sufficient discomfort to inhibit the patient from attempting to remove the securing device 300 and / or treatment component and / or prevent the patient from removing the securing device 300.

[0104] Reference Figures 3-5The device 300 includes a first portion 302, a second portion 304, and a third portion 306. The first portion 302 is configured to be positioned on and adhered to the patient's nose. The second portion 304 is configured to be positioned on and adhered to the patient's cheek and / or jaw. The third portion 306 extends away from the first portion 302 and the second portion 304 and is configured to secure an elongated treatment member 401 to the device 300. In some embodiments, the device 300 does not include the third portion 306, and in some embodiments, the device includes two or more third portions 306. The device 300 has a top side 301 and a bottom side 303. The top side 301 is configured to face away from the patient's face when the device 300 is adhered to the patient, and the bottom side 303 is configured to be positioned on or adjacent to the patient's skin. The device 300 also includes a longitudinal dimension L extending along the first portion 302 and the second portion 304, a width dimension extending between the longitudinal side surface of the first portion 302 and the longitudinal side surface of the second portion 304, and a width dimension extending perpendicular to the longitudinal dimension L. Figure 3 The thickness dimension between the top and bottom sides of the device 300 is measured by plane.

[0105] like Figure 4 As best shown, device 300 may include one or more layers disposed along the thickness of device 300. One or more layers may include a first layer 308 at a top side 301, a second layer 310 at a bottom side 303, and an adhesive element 312 between the first layer 308 and the second layer 310. In some embodiments, the adhesive element 312 extends only along the bottom side 303 of the first portion 302 and the second portion 304, and not along the bottom side 303 of the third portion 306, because the third portion 306 is not intended to be adhered to the patient's skin. In some embodiments, the first layer 308 comprises fabric or other breathable material, and the second layer 310 comprises a backing paper configured to be removed from device 300 before adhering device 300 to the patient's skin to expose the adhesive element 312. The first layer 308 and the second layer 310 may additionally or alternatively include other materials.

[0106] In some embodiments, adhesive element 312 includes absorbent material, wherein the adhesive is disposed on one or more sides of the absorbent material. In some embodiments, the absorbent material is impregnated with adhesive, and in some embodiments, the adhesive may comprise a solid layer adhered to the absorbent material. According to several aspects of the art, the adhesive is disposed on the absorbent material by spraying, dip coating, film deposition, or other suitable processes. In some embodiments, adhesive element 312 does not include absorbent material. In these and other embodiments, the adhesive may be applied directly to the first layer 308 by spraying, dip coating, film deposition, etc.

[0107] like Figure 3 As shown, the first portion 302 of the device 300 may include a first terminal 302a, a second terminal 302b, and a length extending along a first dimension through the first terminal 302a and the second terminal 302b. The first portion 302 may include a first end region 332a, a second end region 332b, and a middle region 332c. The first end region 332a is configured to be positioned on and adhered to a first nasal alar region and / or sidewall of the patient's nose. The second end region 332b is configured to be positioned on and adhered to a second nasal alar region and / or sidewall of the patient's nose. The middle region 332c extends between the first end region 332a and the second end region 332b. The middle region 332c is configured to be positioned on and adhered to a nasal bridge region and / or sidewall of the patient's nose. In some embodiments, the width and / or surface area of ​​the first end region 332a and the second end region 332b are greater than the width of the intermediate region 302c. In these and other embodiments, the length of the intermediate region 332c may be greater than the length of each of the first end region 332a and the second end region 332b. According to some embodiments, the width of the intermediate region 332c is generally constant along the length of the intermediate region and / or the entire length of the first portion 302.

[0108] like Figure 4 As shown, in some embodiments, the device 300 includes an elastic member 314 positioned along the entire length or a portion of the length of the first portion 302. For example, the elastic member 314 may be positioned along the entire or a portion of the length of the intermediate region 332c and / or coincide with the entire or a portion of the length of the intermediate region 332c. The elastic member 314 may be configured to conform the first portion 302 to the shape of a patient's nose. For example, the elastic member 314 may be positioned between the first layer 308 and the adhesive element 312. The elastic member 314 may include a spring, wire, coil, braid, etc. In some embodiments, the elastic member 314 is configured to pull outward on the patient's nose to dilate one or more nasal passages. This dilation may facilitate insertion of a therapeutic member into the nasal passage, breathing through the nasal passages, etc.

[0109] The second portion 304 of the device 300 may include a first terminal 304a, a second terminal 304b, and a length extending along a second dimension through the first terminal 304a and the second terminal 304b. In some embodiments, the first terminal 304a of the second portion 304 corresponds to the second terminal 302b of the first portion 302. In some embodiments, the first terminal 304a of the second portion 304 and the second terminal 302b of the first portion 302 are spaced apart along a longitudinal dimension L of the device 300. The second portion 304 may follow a curved or otherwise tortuous path between the first terminal 304a and the second terminal 304b (see...). Figure 3 (or extend along a basically straight path.)

[0110] The second portion 304 may include a surface area larger than that of the first portion 302 and is configured to adhere with sufficient adhesive strength to a portion of the patient's face, such as the patient's cheek and / or jaw, to cause discomfort if the patient attempts to remove the device 300 prematurely. In some embodiments, the second portion 304 may include one or more slits or openings 316 spaced apart along the longitudinal dimension of the device 300, the one or more slits or openings 316 being configured to receive a treatment component therethrough. Figure 3 and Figure 4 As shown, one or more openings 316 can be arranged as multiple pairs of openings 316 spaced apart from each other along the length of the second portion 304. In use, for example, as... Figure 5 As shown, a portion of the treatment member 401 can pass through the opening 316 such that at least a portion of the length of the treatment member 401 extends along and is secured to at least a portion of the length of the second portion 304. Therefore, the device 300 is configured to reduce the amount of loose or unsecured segments of the treatment member 401 that a patient may grasp when attempting to remove the device 300. In some embodiments, the second portion 304 does not include any openings and is primarily intended to increase the surface area of ​​the device 300 that adheres to the patient's skin.

[0111] The shape, length, and / or width of the second portion 304 may depend on the desired surface area and / or desired adhesive properties of the device 300. Furthermore, the angle between the second dimension of the second portion 304 and the first dimension of the first portion 302 can determine the path along which the second portion 304 extends on the patient's face. This path can be determined by the stiffness of the treatment member 401 to be fixed. For example, a stiffer treatment member may require a larger angle between the first and second dimensions compared to the angle achievable by a more flexible treatment member. This is because a stiffer treatment member may not have the flexibility to make sharp turns toward the ear once it leaves the nostril (e.g., ...). Figure 5 As shown), and therefore a more downward-oriented path must be taken (such as...). Figure 7(As shown). For example, the electrical stimulation device has more internal components and is therefore more rigid than a standard nasogastric feeding tube.

[0112] When the angle between the first and second dimensions is low (e.g., for use with a more flexible therapeutic component), the second portion 304 is configured to extend away from the first portion 302 in the primary lateral direction, for example as... Figure 5 As shown. In such an embodiment, the first end region of the second portion 304 (including the first terminal 304a) can be positioned on and adhered to the patient's nose, for example, at or along the infraorbital region, and the second end region of the second portion 304 (including the second terminal 304b) can be positioned on and adhered to one side of the patient's face, for example, in the cheekbone region, parotid gland region, and / or cheek region.

[0113] When the angle between the first and second dimensions is large (e.g., for use with a stiffer therapeutic component), the second portion 304 is configured to extend away from the first portion 302 in a predominantly downward direction, for example as... Figure 7 As shown. In such an embodiment, the first end region of the second portion 304 (including the first terminal 304a) can be positioned on and adhered to the patient's nose, for example, at or along the infraorbital region, and the second end region of the second portion 304 (including the second terminal 304b) can be positioned on and adhered to a more forward region of the patient's face, such as the chin region, oral cavity region, and / or cheek region.

[0114] The third portion 306 of the device 300 may include a first terminal, a second terminal, and a length extending along a third dimension D through the first and second terminals. The third portion 306 may extend laterally relative to the first portion 302 and / or the second portion 304. In some embodiments, the third portion 306 has a first end region 306a at the junction of the first portion 302, the second portion 304, and / or the junction between the first portion 302 and the second portion 304. The third dimension may be positioned at a non-90-degree angle α relative to the first dimension, the second dimension, and / or the longitudinal dimension L of the device 300. In some embodiments, the third portion 306 extends at a substantially 90-degree angle α away from the longitudinal dimension L of the first portion 302 and the second portion 304. Figure 3 As shown, when the device 300 is adhered to the patient’s face, but before the third part 306 is in a fixed position, the third part 306 may extend laterally away from the second part 304 in a downward direction.

[0115] The third portion 306 may include a first layer 308, a second layer 317, and an adhesive element 315 between the first layer 308 and the second layer 317. The first layer 308 may include a bottom layer, and the second layer 317 may include a top layer. Similar to the first portion 302 and the second portion 304, the first layer 308 may include a breathable material, and the second layer 317 may include a backing paper configured to be removed from the device 300 to expose the adhesive element 315 before the third portion 306 is adhered to the skin of the device 300, the therapeutic element, and / or the patient. The adhesive element 315 may include absorbent material, wherein the adhesive is disposed on one or more sides of the absorbent material. In some embodiments, the absorbent material is impregnated with the adhesive, and in some embodiments, the adhesive may include a solid layer adhered to the absorbent material. According to several aspects of the art, the adhesive is disposed on the absorbent material by spraying, dipping, deposition, or other suitable methods. In some embodiments, the second adhesive element 315 does not include absorbent material. Alternatively, the adhesive may be applied directly to the first layer 308 and / or the second layer 317.

[0116] As previously described, the third portion 306 is configured to secure the elongated therapeutic member to the device 300. In some embodiments, such as... Figure 5 As shown, the second end region 306b of the third portion 306 can be configured to fold over and adhere to another region of the third portion 306, another portion of the device 300, the treatment member 401, and / or the patient's skin. When the first portion 302 and the second portion 304 are adhered to the patient's face and the third portion 306 is not yet folded onto the elongated treatment member 401, the second layer 317 of the third portion 306 can face away from the patient's face. To secure the elongated treatment member 401 to the device 300, the second layer 317 can be removed from the third portion 306 to expose the adhesive element 315, to which the adhesive element 315 of the elongated treatment member 401 can be adhered, and the third portion 306 can be folded toward the longitudinal dimension L of the device 300 to adhere the third portion 306 to itself, another portion of the device 300, the treatment member 401, and / or the patient's skin.

[0117] Additionally or alternatively, the third portion 306 may include a non-adhesive-based mechanism that reversibly (a) secures the elongated treatment member 401 to the third portion 306 and / or (b) secures the third portion 306 to the device 300. For example, in some embodiments, the third portion 306 includes a fastener configured to be detachably coupled to a complementary receiving element and / or mating portion of the device 300 (included on the first portion 302 and / or the second portion 304). In some embodiments, the third portion 306 may be configured to surround and / or be attached to an opening or other retaining structure coupled to or integral with the device 300. For example, the first portion 302 and / or the second portion 304 may include an opening configured to receive a portion of the third portion 306 therethrough. According to several embodiments, the device 300 does not include the third portion 306, but instead includes fastening components coupled to the device 300 (e.g., the first portion 302 and / or the second portion 304). The fastening assembly (not shown) may include a first element configured to engage the treatment member 401 and a second element configured to be releasably coupled to the device 300 (e.g., coupled to a first portion 302 and / or a second portion 304). The fastening assembly may include, for example, buttons and rings, magnets, snaps, clips, etc. In some embodiments, the device 300 includes one or more third portions 306 and one or more fastening assemblies.

[0118] In some embodiments of this technology, the device 300 may include a channel 318 extending along at least a portion of the first portion 302 and / or at least a portion of the second portion 304. For example, as Figure 4 As shown, channel 318 may extend along or adjacent to the periphery of the first portion 302 and the second portion 304. In some embodiments, the portion and / or material defining channel 318 of device 300 does not include an adhesive. For example, a first layer 308 of the first portion 302 and the second portion 304 may define channel 318 (instead of adhesive element 312). Channel 318 may be configured to receive a release agent therethrough to enable the device to mechanically detach from a patient's skin. In some embodiments, device 300 includes valve 320, which is fluidly coupled to channel 318 and configured to receive a release agent. Figure 6 As shown, valve 320 can be configured to receive a release agent from an external source 322. External source 322 may include a bottle, syringe, aerosol can, or other suitable dispensing device. In some embodiments, device 300 does not include a channel and / or valve.

[0119] The release agent can be configured to interact with the adhesive to reduce the adhesive bond strength between the device 300 and the patient's skin, allowing the device 300 to be removed from the patient's face without causing significant discomfort. In some embodiments, the release agent comprises a medical-grade adhesive remover. The release agent can be water-based or solvent-based. The channel 318 can be configured to distribute the release agent along the length of the device 300. In embodiments where one or more portions of the device 300 include an absorbent material, the absorbent material can absorb the release agent, and the release agent can diffuse through the absorbent material to areas of the device 300 that are not in direct contact with the channel 318.

[0120] In some embodiments, a release agent is not required to mechanically separate the device from the patient's face. For example, the adhesive may include a photosensitive adhesive that degrades when exposed to light. In such embodiments, the device may include one or more opaque materials configured to be positioned between the adhesive material and the light source within the device. The one or more opaque materials may be configured to be removed from the device when it is intended to be removed from the patient's face. For example, the first material disclosed herein may include an opaque layer configured to separate from the adhesive element. Thus, when the opaque layer is removed from the device, the adhesive element can be exposed to light and can degrade sufficiently to allow the device to be mechanically separated from the patient's face.

[0121] In some embodiments, the device may include a first or top layer and a second or bottom layer. The top layer may include an adhesive on its underside, which is configured to adhere to the bottom layer. The bottom layer may include an adhesive on its underside, which is configured to adhere the bottom layer and / or the device to the patient. When the device is adhered to the patient's skin and the top layer is removed (with or without the therapeutic component attached), the portion of the device remaining on the patient is the bottom layer. The bottom layer may be transparent or otherwise configured to allow light to pass through it, such that over time, the light passing through the bottom layer deactivates the adhesive, thereby allowing the device to be removed.

[0122] According to some embodiments, a method of securing an external portion of a transnasally inserted elongated therapeutic member to a device and thus to a patient's face may include adhering a nasal portion of the device (e.g., a first portion 302 as described herein) to the patient's nose. In some embodiments, adhering the nasal portion of the device to the patient's nose includes removing backing material (e.g., a second layer 310 as described herein) from the nasal portion to expose the adhesive and positioning the nasal portion adjacent to the patient's nose. In some embodiments, adhering the nasal portion to the nose includes applying pressure to the nasal portion once it is positioned adjacent to the patient's nose. The method may also include conforming an elastic member of the nasal portion to the patient's nose.

[0123] The method may include removing backing material (e.g., the second layer 310 described herein) from a fixing portion of the device (e.g., the third portion 306 described herein). A segment of the external portion of the transnasal long therapeutic member may be positioned as an adhesive adjacent to the fixing portion, and the fixing portion may be folded over the segment of the external portion of the transnasal long therapeutic member and adhered to the device. In some embodiments, the fixing portion includes an adhesive such that a segment of the external portion of the transnasal long therapeutic member adheres to the fixing portion, and the fixing portion is adhered to the device.

[0124] In some embodiments, the method includes positioning a second segment of the external portion of a transnasal long therapeutic member through one or more openings defined by a facial portion of the device (e.g., the second portion 304 described herein), such that at least a portion of the long therapeutic member extends along the longitudinal dimension of the device. The second segment of the external portion of the transnasal long therapeutic member may be inserted through the multiple openings such that the greater length of that portion of the long therapeutic member extends along the longitudinal dimension of the device. In some embodiments, a backing material (e.g., the second layer 310 described herein) may be removed to expose the adhesive, and the facial portion may be positioned adjacent to and adhered to the patient's cheek. In some embodiments, adhering the facial portion to the cheek includes applying pressure to the facial portion once it is positioned adjacent to the patient's cheek.

[0125] According to some embodiments, a method for removing the device described herein from a patient's face to remove an elongated therapeutic component from the patient may include applying a release agent to the device. In some embodiments, the release agent is delivered from an external source to a valve of the device. The release agent may be delivered from the valve to a channel in the device, and the release agent may be delivered through the channel to one or more locations remote from the valve. In some embodiments, the device includes one or more absorbent materials configured to deliver the release agent to one or more locations remote from the channel. The release agent may interact with an adhesive (e.g., degrade, dissolve, swell, etc.) to reduce the adhesive bond strength between the device and the patient's face, allowing the device to be mechanically detached from the patient's face.

[0126] in conclusion

[0127] While numerous embodiments of devices, systems, and methods for securing long therapeutic components to a patient's face have been described above, this technology can be applied to other applications and / or other methods. Furthermore, other embodiments besides those described herein are also within the scope of this technology. Additionally, several other embodiments of this technology may have constructions, components, or processes different from those described herein. Therefore, those skilled in the art will accordingly understand that this technology may have other embodiments with additional elements, or that it may have other embodiments without several features shown and described above.

[0128] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Singular or plural terms may also include plural or singular terms, respectively, where the context permits. While specific embodiments and examples of this technology have been described above for illustrative purposes, those skilled in the art will recognize that various modifications are possible within the scope of this technology. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0129] Furthermore, unless the word “or” is explicitly limited to referring only to one item that is different from the other items in a list of two or more items, its use in such a list should be interpreted as including: (a) any one item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” is used throughout to mean including at least the stated features, such that no further number of the same features and / or other features of additional types are excluded. It will also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the art. Furthermore, while advantages associated with certain embodiments of the art have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to fall within the scope of the art. Therefore, this disclosure and related art may include other embodiments not expressly shown or described herein.

[0130] As used herein, the terms “approximately,” “basically,” “about,” and similar terms are used as approximate terms rather than terms of degree and are intended to describe the inherent variations in measured or calculated values ​​that would be recognized by one of ordinary skill in the art.

Claims

1. A device (300) configured to fix the position of an external portion of an elongated therapeutic member (401) inserted into a patient's body cavity, the device comprising: The first part (302) is configured to adhere to the patient's nose; A second portion (304) extends from the first portion (302) along the longitudinal dimension (L) of the device (300), wherein the second portion (304) is configured to adhere to the patient's cheek; and The third part (306) has a first end region (306a) at the junction between the first part (302) and the second part (304), wherein the third part (306) extends from the first part (302) and the second part (304) in a direction laterally away from the longitudinal dimension (L) of the device (300), and wherein the third part (306) is configured to fold over a section of the external portion of the elongated treatment member (401) and be secured to the device (300), such that the elongated treatment member (401) is secured to the device (300). Each of the first portion (302) and the second portion (304) includes an adhesive, and Each of the first part (302), the second part (304), and the third part (306) includes an integrated structure. Its features are, The adhesive is a high-viscosity adhesive with strong adhesion, and the high-viscosity adhesive is configured to prevent the device (300) from being mechanically removed from the patient's face without discomfort. The device includes a channel (318) extending along at least a portion of the first portion (302) and at least a portion of the second portion (304), wherein the channel (318) is configured to receive a release agent through the channel (318) to enable the device to be mechanically detached from the patient’s face without discomfort.

2. The apparatus (300) according to claim 1, wherein, The release agent is configured to interact with the adhesive to reduce the adhesive bond strength between the device (300) and the patient's skin, allowing the device (300) to be removed from the patient's face without causing the patient severe discomfort.

3. The apparatus (300) according to claim 1 further comprises a first material and a second material, wherein, The first material and the second material extend together with the first portion (302) and the second portion (304), wherein the adhesive is positioned between the first material and the second material.

4. The apparatus (300) according to claim 2 further comprises a first material and a second material, wherein, The first material and the second material extend together with the first portion (302) and the second portion (304), wherein the adhesive is positioned between the first material and the second material.

5. The apparatus (300) according to claim 3, wherein, The first material is configured to face away from the patient’s face when the device (300) is adhered to the patient’s face, and wherein the second material is configured to be removed before the device (300) is adhered to the patient’s face.

6. The apparatus (300) according to claim 4, wherein, The first material is configured to face away from the patient’s face when the device (300) is adhered to the patient’s face, and wherein the second material is configured to be removed before the device (300) is adhered to the patient’s face.

7. The apparatus (300) according to any one of claims 1-6, wherein: The third portion (306) includes a first side and a second side opposite the first side along the thickness of the third portion (306), and when the first portion (302) and the second portion (304) are adhered to the patient's face via adhesive on the first portion (302) and the second portion (304), and the third portion (306) extends laterally away from the first portion (302) and the second portion (304) along the longitudinal dimension (L) of the device (300) and before the third portion (306) is folded onto a section of the external portion of the elongated treatment member (401) and secured to the device (300), such that the elongated treatment member (401) is secured to the device (300), the second side is positioned near the patient's face. The device (300) further includes a removable element and an adhesive element (315) positioned on the first side of the third part (306), wherein the adhesive element (315) is positioned between the removable element and the first side.

8. The apparatus (300) according to any one of claims 1-6, wherein, The second portion (304) of the device (300) includes one or more openings (316) configured to receive the elongated treatment member (401) such that the elongated treatment member (401) extends along the longitudinal dimension (L) of the device.

9. The apparatus (300) according to claim 7, wherein, The second portion (304) of the device (300) includes one or more openings (316) configured to receive the elongated treatment member (401) such that the elongated treatment member (401) extends along the longitudinal dimension (L) of the device.

10. The apparatus (300) according to any one of claims 1-6, 9, wherein, The portion of the device that defines the channel does not include the adhesive.

11. The apparatus (300) according to claim 7, wherein, The portion of the device that defines the channel does not include the adhesive.

12. The apparatus (300) according to claim 8, wherein, The portion of the device that defines the channel does not include the adhesive.

13. The device (300) according to any one of claims 1-6, 9, 11-12 further includes a valve (320) fluidly coupled to the channel (318) and configured to receive a release agent from an external source (322).

14. The apparatus (300) of claim 7 further includes a valve (320) fluidly coupled to the channel (318) and configured to receive a release agent from an external source (322).

15. The apparatus (300) of claim 8 further includes a valve (320) fluidly coupled to the channel (318) and configured to receive a release agent from an external source (322).

16. The apparatus (300) of claim 10 further includes a valve (320) fluidly coupled to the channel (318) and configured to receive a release agent from an external source (322).

17. The apparatus (300) according to any one of claims 1-6, 9, 11-12, 14-16, wherein, The third portion (306) extends at an angle (α) of 90 degrees away from the longitudinal dimension (L) of the first portion (302) and the second portion (304).

18. The apparatus (300) according to claim 7, wherein, The third portion (306) extends at an angle (α) of 90 degrees away from the longitudinal dimension (L) of the first portion (302) and the second portion (304).

19. The apparatus (300) according to claim 8, wherein, The third portion (306) extends at an angle (α) of 90 degrees away from the longitudinal dimension (L) of the first portion (302) and the second portion (304).

20. The apparatus (300) according to claim 10, wherein, The third portion (306) extends at an angle (α) of 90 degrees away from the longitudinal dimension (L) of the first portion (302) and the second portion (304).

21. The apparatus (300) according to claim 13, wherein, The third portion (306) extends at an angle (α) of 90 degrees away from the longitudinal dimension (L) of the first portion (302) and the second portion (304).

22. The apparatus (300) according to any one of claims 1-6, 9, 11-12, 14-16, 18-21, wherein, The elongated treatment component (401) is at least one of the following: a feeding tube, an endoscope, or an electrical stimulation device.

23. The apparatus (300) according to claim 7, wherein, The elongated treatment component (401) is at least one of the following: a feeding tube, an endoscope, or an electrical stimulation device.

24. The apparatus (300) according to claim 8, wherein, The elongated treatment component (401) is at least one of the following: a feeding tube, an endoscope, or an electrical stimulation device.

25. The apparatus (300) according to claim 10, wherein, The elongated treatment component (401) is at least one of the following: a feeding tube, an endoscope, or an electrical stimulation device.

26. The apparatus (300) according to claim 13, wherein, The elongated treatment component (401) is at least one of the following: a feeding tube, an endoscope, or an electrical stimulation device.

27. The apparatus (300) according to claim 17, wherein, The elongated treatment component (401) is at least one of the following: a feeding tube, an endoscope, or an electrical stimulation device.

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