Stationary block and adjustable locking mechanism therefor

Abstract

The present disclosure relates to a device that, in some embodiments, can be used to securely fasten a medical device (e.g., an endotracheal tube) in place for use by a patient. In various embodiments, the device can include a frame and an adjustable locking mechanism slidably connected to the frame. The adjustable locking mechanism can be characterized by a cylindrical block, a swivel lock portion, and an adjustable clip. A device for securely fastening an extension device to prevent movement includes a frame with a radial tracking portion and an adjustable locking mechanism slidably connected to the radial tracking portion.

Description

Background Art

[0001] (Cross - reference to related applications) This application claims the benefit and priority of co - pending U.S. Provisional Patent Application No. 63 / 342,941, filed on May 17, 2022, entitled "Resting Block and Adjustable Locking Mechanism for Same", the disclosure of which is incorporated herein by reference in its entirety.

[0002] The worldwide pandemic of the coronavirus and other medical emergencies have required the use of intubation to ensure that patients receive sufficient oxygen. As is well - known in the art, intubation requires positioning the distal end or tip of an endotracheal tube (ETT) within the patient's trachea and ensuring that the distal end or tip of the ETT remains in place. Referring to FIG. 6, a first embodiment of a conventional system 80 includes inserting the ETT (e.g., loosely) into an endotracheal tube holder 82, which serves several purposes. In some embodiments, the endotracheal tube holder 82 includes a (semi - rigid, plastic) frame 86 that prevents the patient from biting their own tongue, cheek, and / or lip and from biting the ETT, and from occluding or otherwise impairing the airflow through the ETT.

[0003] Referring to FIG. 7, a second embodiment of a conventional endotracheal tube holder 90 is shown. The embodied endotracheal tube holder 90 may include a radial track portion 95 to which a positioning / fixing device 91 is slidably and removably attached. The positioning / fixing device 91 is adapted to slidably traverse the radial track portion 95 so as to position the ETT fixing portion 94 at a desired location. The positioning / fixing device 91 may include a locking mechanism 92 for fixing the device at a desired location on the radial track portion 95, as well as an ETT fixing portion 94 configured to fix the ETT. In some variations, the ETT may be inserted into the fixing portion 94, and a strap 93 may be passed around the outer circumference of the ETT and used to fix it to the positioning / fixing device 91. A comfort pad 96 may be disposed on the inside of the radial track portion 95.

[0004] Many such conventional systems 90 are often structured and arranged to remain outside the patient's mouth. For example, in addition to the radial track portion 95, comfort pad 96, and positioning / fixing device 91 that remain outside the patient's mouth, a pair of wings 97 to which an adjustable head strap 99 may be attached are typically formed with or attached to the radial track portion 95. Each wing 97 includes a cheek pad 98 that is structured and arranged to rest on the patient's cheek and protect the patient's cheek from irritation caused by the wing 97. Problematically, the cheek pad 98 itself can cause discomfort to the patient's cheek. Further, conventional locking features loosen over time. Accordingly, the positioning of the distal end of the ETT can be detrimentally impaired. Finally, the embodied endotracheal tube holder 90 does not include a bite block that is inserted into the patient's mouth to keep the patient's mouth open and prevent the patient from biting themselves or occluding the ETT. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0005] (Summary of the Invention) Therefore, it would be desirable to provide a device for securely anchoring an ETT at a desired position and depth within a patient's trachea.

[0006] Generally, one aspect of the present invention features a device for securely fastening an extension device to prevent movement. The device can include a frame including a radial tracking portion, and an adjustable locking mechanism slidably connected to the radial tracking portion.

[0007] In various embodiments, the radial tracking portion can include alternating teeth and gaps therebetween. The frame can also include a pair of extension arms, each of the pair of extension arms being fixedly attached to a bite block disposed at the distal end of the radial tracking portion and / or the frame. The bite block can be formed from a material softer than the frame (e.g., a semi-rigid polymer). In some embodiments, the extension device is an endotracheal tube (e.g., having a diameter in the range of 2 mm to 12 mm).

[0008] Generally, another aspect of the present invention features an adjustable locking mechanism including an adjustable clamp, a swivel lock portion, and an adjustable clip attached to the swivel lock portion for restraining an object.

[0009] In various embodiments, the adjustable clamp can include a block disposed at its proximal end. The block can be characterized by a pair of protrusions for containing a radial track having teeth and corresponding gaps therebetween, and a connection portion disposed at the distal end of the block. In some embodiments, the adjustable clamp can also include a disk-shaped portion disposed between the block and the connection portion. In some cases, the block has a cylindrical shape. In some cases, the pair of protrusions is L-shaped. The swivel lock portion can include a rotatable substrate, a hollow portion disposed at one end of the rotatable substrate, and a protrusion adapted to prevent the swivel lock portion from moving when inserted into the gap between adjacent teeth of the radial track and disposed on the hollow portion. In some cases, the hollow portion has a cylindrical shape. The object can be an endotracheal tube (e.g., having a diameter in the range of 2 mm to 12 mm).

[0010] Generally, another aspect of the present invention features a method for securely fastening an extension device to a user. The method can include securing a frame with a radial tracking portion centered on the user's head, sliding an adjustable locking mechanism to a desired location along the radial tracking portion, and using the adjustable locking mechanism to lock the extension device in place.

[0011] In various embodiments, the desired location is proximate to the user's mouth such that the extension device can advantageously be inserted into the user's mouth. The extension device can be an endotracheal tube.

Brief Description of the Drawings

[0012] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale; instead, emphasis is generally placed on illustrating the principles of the present invention. In the following description, various embodiments of the present invention are described with reference to the following drawings.

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DETAILED DESCRIPTION OF THE INVENTION

[0028] (Detailed Description) Referring to FIGS. 1A and 1B, an embodiment of an endotracheal tube holder (hereinafter referred to as the stationary block (RB) 100) for use in conjunction with an intubation procedure (e.g., disposable, non-reusable) is shown. Such intubation procedures may be used for surgical procedures or may be used by an intensive care unit (ICU), trauma / burn unit, and the like. In some implementations, the RB 100 may be structured and arranged to facilitate positioning of an endotracheal tube (ETT) 10 (e.g., 2 mm to 12 mm in diameter) properly inserted into the trachea of an adult (i.e., 18 years and older) patient. Advantageously, the RB 100 is adapted to hold the ETT 10 in a secure position to prevent the ETT 10 from shifting position. The present invention is described with respect to a specific medical use for securing the ETT 10 in a desired location within a patient's airway, but one of ordinary skill in the art will understand that the concepts taught can be applied to other technical fields, not limited to, but including, securely fixing the location of cables, rods, hoses, and the like, for illustrative purposes.

[0029] In some applications, the RB 100 may include a support frame 20 in combination with an adjustable locking mechanism 30. Advantageously, the support frame 20 includes a pair of (e.g., soft) bite blocks 25 configured to prevent the patient from biting themselves (e.g., their tongue, lips, and / or cheeks) or occluding the ETT 10 (e.g., 2 to 12 mm in diameter).

[0030] (Frame and Bite Block) As shown in FIG. 2, in some embodiments, the support frame 20 may be structured and arranged to include a radial track portion 22 (e.g., curved or arcuate). The length of the frame may be about 3.9 inches (+ / -0.05) with a frame diameter of about 0.19 (+ / -0.05) inches. In some variations, the support frame 20 may be structured and arranged to support the weight of the ETT 10. In some variations, the support frame 20 may be constructed from materials such as polyamide or nylon (e.g., Nylon® 66, Zytel® 101L NC010 (natural), etc.), injection molded polymers, wires coated with polyvinyl chloride, and equivalents (e.g., semi-rigid, plastic). Alternatively, in some implementations, the support frame 20 may be manufactured from metal, rubber, or equivalents. Preferably, the support frame 20 may be made from a biodegradable material such as wood.

[0031] A pair of (e.g., extending) arms 24 may be formed with and / or fixedly attached to the radial track portion 22, for example, at or near each of the distal end 21 and proximal end 23 of the radial track portion 22. The pair of (e.g., extending) arms 24 may be configured to be compressed towards each other to facilitate insertion of the (e.g., extending) arms 24 into the patient's mouth. In some variations, protrusions 27 may be formed on each of the (e.g., extending) arms 24 for attaching strings, straps, and equivalents to prevent the patient from self-extubating. The pair of (e.g., extending) arms 24 may also be constructed from materials such as polyamide or nylon (e.g., Nylon® 66, Zytel® 101L NC010 (natural), etc.), injection molded polymers, wires coated with polyvinyl chloride, and equivalents (e.g., semi-rigid, plastic).

[0032] Advantageously, in some variations, the bite blocks 25 may be fixedly attached to the respective distal ends of the arms 24. For patient comfort, the bite blocks 25 are structured and arranged to be softer than the support frame 20 but resistant to being bitten through by the patient. Typical bite block lengths and widths may be about 0.88 (+ / - 0.05) inches and 0.69 (+ / - 0.05) inches, respectively. The distance between the bite blocks should be about 2.38 (+ / - 0.05) inches. In some implementations, the bite blocks 25 may be made from (e.g., soft) rubber, thermoplastic elastomer (e.g., Versaflex® 6258-1 (natural)), or a (e.g., plastic or semi-rigid) polymer such as a polypropylene copolymer (PPC) that is softer than a homopolymer but more elastic and resistant to stress cracking. In some variations, the semi-rigid polymer may have a Shore A durometer hardness greater than 50. Advantageously, the use of PPC is preferred over a homopolymer when the device is subjected to gamma or steam sterilization for reuse.

[0033] (E.g., soft) pairs of bite blocks are structured and arranged to fit comfortably over the patient's wisdom teeth and / or most posterior molars. Advantageously, the stationary blocks do not include cheek pads, which prevents facial and / or oral ulcers.

[0034] In some implementations, the radial track portion 22 is structured and arranged to include a flanged portion 26 on its outer peripheral surface where its plurality of teeth 29 and corresponding plurality of gaps 28 are formed. In some variations, the flanged portion 26 extends from the distal end 21 to the proximal end 23 of the radial track portion 22. Optionally, walls may be formed at the distal end 21 and proximal end 23 of the radial track portion 22 to prevent the adjustable locking mechanism 30 from slipping out of the flanged portion 26. Advantageously, the teeth 29 and gaps 28 are structured and arranged to cooperate with the adjustable locking mechanism 30 to securely attach the adjustable locking mechanism 30 to the radial track portion 22, and as a result, to fix the ETT 10 in a desired position.

[0035] As shown in FIG. 2, in some embodiments, the adjustable locking mechanism 30 is structured and arranged to include at least three elements, namely, an adjustable clamp 40, a lever portion 50, and an adjustable (e.g., ETT) clip 60. Exemplary dimensions for the adjustable locking mechanism 30 include a height of about 0.28 (+ / -0.05) inches and a baseline length of about 2.63 inches (+ / -0.05).

[0036] (Adjustable clamp) Referring to FIGS. 3A - 3D, an exemplary embodiment of the adjustable clamp 40 is shown. In some embodiments, the (e.g., monolithic) adjustable clamp 40 is structured and arranged to fit onto the flanged portion 26 of the radial track portion 22 in a slidable and lockable arrangement. In some applications, the proximal portion (e.g., formed in a cylindrical shape) is sized to slidably fit into the conduit 54 within the lever portion 50 and is configured to include a (e.g., cylindrical) block portion 42. A pair of (e.g., opposing) L - shaped arms 44a, 44b may be formed at the proximal end of the (e.g., cylindrical) block portion 42, leaving a plenum space 46 configured to accommodate the flanged portion 26. In some variations, the first (e.g., upper) L - shaped protrusion or arm 44a rests on or extends along the first (e.g., upper) portion of the flanged portion 26, and the second (e.g., lower) L - shaped protrusion or arm 44b (e.g., diametrically opposed) rests on or extends along the second (e.g., lower) portion of the flanged portion 26.

[0037] (E.g., disc - shaped) intermediate portion 48 is joined to the (e.g., cylindrical) block portion 42 at its distal end. In some applications, the (e.g., disc - shaped) intermediate portion 48 has an outer diameter larger than that of the (e.g., cylindrical) block portion 42. Also, the (e.g., disc - shaped) intermediate portion 48 is structured and arranged to include a shelf portion 49 (the purpose of which will be described in more detail below) formed proximate to the distal end of the (e.g., cylindrical) block portion 42.

[0038] A connection portion 41 for attaching the adjustable clip 50 to the adjustable clamp 40 (e.g., securely and removably) may be formed on opposite sides of the (e.g., disc - shaped) intermediate portion 48. In some implementations, the connection portion 41 may include a first strut 43 and a second strut 47 that define an opening or gap 45 therebetween. The width of the opening or gap 45 is sized to provide a tight interference fit with the swivel lock portion 50.

[0039] Swing Lock Portion

[0040] Referring to FIGS. 4A - 4B, an exemplary embodiment of a swing lock portion 50 for activating and releasing an adjustable clamp 40 of an adjustable locking mechanism 30 is shown. In some applications, the swing lock portion 50 includes a substrate 52 (e.g., oval-shaped) having a first or upper surface 51 and a second or lower surface 53. An annular portion 58 (e.g., hollow, cylindrical-shaped) having a (e.g., circular) conduit 54 extending through the substrate 52 to the second or lower surface 53 may be formed at one end of the first or upper surface 51. A chamfered or rounded portion 57 may be formed at the end centered on the peripheral edge of the substrate 52.

[0041] (E.g., circular) conduit 54 should be dimensioned to provide a tight sliding and rotatable fit with a (e.g., cylindrical) block portion 42 such that the swing lock portion 50 can be rotated approximately 180 degrees when the (e.g., cylindrical) block portion 42 is inserted into the conduit 54. A protrusion 59 for locking the adjustable locking mechanism 30 to the radial track portion 22 may be formed on the (e.g., cylindrical) annular portion 58. In some variations, the protrusion 59 is dimensioned such that when the protrusion 59 is rotated into the gap 28 between adjacent teeth 29, the thickness of the protrusion 59 will form a tight interference fit with the teeth 29.

[0042] A second protrusion 56 may be formed on the second or lower surface 53 of the substrate 52 proximate the (e.g., circular) conduit 54. The second protrusion 56 abuts against the (e.g., disk-shaped) intermediate portion 48 of the adjustable clamp 40, and more specifically, contacts and extends along the shelf portion 49 of the (e.g., disk-shaped) intermediate portion 48 of the adjustable clamp 40. In operation, the second protrusion 56 limits and defines the range within which the swing lock portion 50 can be rotated from the "unlocked" position.

[0043] (Adjustable Clip) Referring to FIGS. 5A-5D, an exemplary embodiment of an adjustable (e.g., EET) clip 60 for holding and securing the EET10 is shown. In some implementations, the adjustable (e.g., EET) clip 60 may have a rounded triangular shape with three sides 62, 64, 66, the lengths of which may vary from about 1.2 inches to about 0.9 to about 1.1 inches, respectively. Portions 61a, 61b, 61c of the sides 62, 64, 66 may be removed at or near the corners of the adjustable (e.g., EET) clip 60 to provide flexibility. The figure shows that the removed portions 61a, 61b, 61c are oval or elliptical in shape, but this is done for illustrative purposes only. One of ordinary skill in the art can understand that other shapes may also be used.

[0044] In some applications, two of the sides 62, 64 include grips 63a, 63b configured to adapt to and apply a compressive force to the ETT10 to secure the ETT10 within the adjustable (e.g., EET) clip 60. An attachment device 68 may be formed at the junction between these two sides 62, 64. In some variations, the attachment device 68 may include a pair of L-shaped protrusions 67 with an opening 69 therebetween. The attachment device 68 may be structured and arranged to form a tight interference fit within a gap 45 defined between a first strut 43 and a second strut 47 of the connection portion 41.

[0045] In some implementations, the third side 66 and the second side 64 touch at the joint, while there is an opening 70 between the third side 66 and the first side 62. To close the opening 70 and compress the ETT 10 within the adjustable (e.g., EET) clip 60, a series of (e.g., serrated) teeth 65 may be formed on the third side 66, and a tip portion 71 may be formed on the first side 62. During operation, once the EET 10 is inserted inside the adjustable (e.g., EET) clip 60 in proximity to the pair of grips 63a, 63b and a compressive force is applied to the first side 62 and the second side 64 of the adjustable (e.g., EET) clip 60, the opening 70 closes and the (e.g., serrated) teeth 65 are extended across the tip portion 71. Once the EET 10 is properly secured, the compressive force is interrupted and the tip portion 71 remains properly engaged with one of the (e.g., serrated) teeth 65, fixing and securing the third side 66 to the first side 62 and also securing the EET 10 within the adjustable (e.g., EET) clip 60.

[0046] When used by a medical professional, once the ETT 10 is properly inserted through the patient's mouth and into the patient's airway and positioned at the desired depth within the patient's trachea, the arms 24 of the (semi-rigid, plastic) frame 20 are compressed towards each other and the arms 24 can be inserted into the patient's mouth. The medical professional then positions the bite block 25 such that the bite block 25 is aligned with the patient's wisdom teeth or the most posterior molars. Once the bite block 25 is properly aligned, the compressive force on the arms 24 of the frame 20 can be removed, allowing the arms 24 to return to their original positions (e.g., elastically or elastoplastically).

[0047] The medical professional may then secure the ETT 10 to an adjustable locking mechanism 30 located on the radial tracking portion 22 of the (semi-rigid, plastic) frame 20. For example, in some applications, the swivel lock portion 50 of the adjustable locking mechanism 30 may be rotated (e.g., downwardly) approximately 90 degrees to engage and disengage the locking feature of the adjustable locking mechanism 30. Once disengaged, the adjustable locking mechanism 30 may be moved along the radial track portion 22 until the adjustable locking mechanism 30 is aligned with the proximal end of the ETT 10. Advantageously, moving the adjustable locking mechanism 30 along the radial track portion 22 may occur seamlessly and may proceed from the proximal end 21 to the distal end 23 or from the distal end 23 to the proximal end 12.

[0048] The medical professional may then carefully insert (e.g., slide) the ETT 10 into the locking feature (e.g., adjustable clip 60), compress the first side 62 and the second side 64 of the adjustable clip 60, and compress the ETT 10 between the grips 63a, 63b. Once secured, the swivel lock portion 50 of the adjustable locking mechanism 30 may be rotated (e.g., upwardly) approximately 90 degrees to re-engage the locking feature of the adjustable locking mechanism 30.

[0049] Finally, the medical professional may adjust the location of the adjustable locking mechanism 30 and its positioning along the radial tracking portion 22. Advantageously, the lateral adjustment of the adjustable locking mechanism 30 allows the medical professional to position the ETT 10 to accommodate the orientation of the patient.

[0050] Certain embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order or sequential order shown to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous. Other steps or stages may be provided to or eliminated from the described processes. Accordingly, other implementations are within the scope of the following claims.

[0051] Each numerical value presented and inserted herein is assumed to represent the minimum or maximum value within the range for the corresponding parameter. Thus, when added to a claim, the numerical value provides clear support for claiming a range that can exist above or below the numerical value in accordance with the teachings herein. All values between the minimum and maximum values within each numerical range presented herein (including the graphs shown in the figures) are assumed and clearly supported herein, subject to the number of significant digits presented within each particular range. Unless a claim specifically recites inclusion, each numerical value presented herein is not to be considered limiting in any respect.

[0052] Unless otherwise expressly stated elsewhere in this application, as used herein, when the terms "substantially" or "about" precede a quantitative value, the disclosure also includes the specific quantitative value itself, as well as, in various instances, variations of ±1%, ±2%, ±5%, and / or ±10% from the nominal value, unless otherwise indicated or inferred.

[0053] Exemplary embodiments are described herein, but those skilled in the art will understand various other features and advantages of the present invention apart from those specifically described above. Therefore, the foregoing is merely illustrative of the principles of the present invention, and it is to be understood that various modifications and additions, as well as all combinations and permutations of the various elements and components listed herein, can be made by those skilled in the art without departing from the spirit and scope of the present invention. Accordingly, the appended claims should not be limited by the specific features shown and described, but should be construed to cover any obvious modifications and their equivalents.

[0054] The following are the claims.

Claims

1. A device for securely fastening an extension device to prevent movement, said device comprising: a frame having a radial tracking portion; an adjustable locking mechanism slidably connected to said radial tracking portion and comprising a device.

2. The device according to claim 1, wherein said radial tracking portion comprises a plurality of alternating teeth and gaps therebetween.

3. The device according to claim 1, wherein said frame further comprises a pair of extension arms, each of said pair of extension arms being fixedly attached to said radial tracking portion.

4. The device according to claim 1, further comprising a bite block disposed at a distal end of said frame.

5. The device according to claim 4, wherein said bite block is formed of a material softer than said frame.

6. The device according to claim 5, wherein said softer material comprises a semi-rigid polymer.

7. The device according to claim 1, wherein said extension device comprises an endotracheal tube.

8. The device according to claim 7, wherein said endotracheal tube has a diameter in the range of 2 mm to 12 mm.

9. An adjustable locking mechanism, comprising: an adjustable clamp; a swivel lock portion; an adjustable clip attached to said swivel lock portion for restraining an object and comprising an adjustable locking mechanism.

10. Said adjustable clamp comprises: a block disposed at its proximal end, said block comprising a pair of protrusions for containing a radial track having a plurality of teeth and corresponding gaps therebetween; a connection portion disposed at its distal end and comprising an adjustable locking mechanism according to claim 9.

11. The adjustable locking mechanism according to claim 10, wherein said adjustable clamp further comprises a disk-shaped portion disposed between said block and said connection portion.

12. The adjustable locking mechanism according to claim 10, wherein said block has a cylindrical shape.

13. The adjustable locking mechanism according to claim 10, wherein said pair of protrusions is L-shaped.

14. Said swivel lock portion comprises: a rotatable substrate; a hollow portion disposed at one end of said rotatable substrate; a protrusion disposed on said hollow portion and adapted to prevent said swivel lock portion from moving when inserted into a gap between adjacent teeth of a radial track. The adjustable locking mechanism according to claim 9, comprising

15. The adjustable locking mechanism according to claim 14, wherein the hollow portion has a cylindrical shape.

16. The adjustable locking mechanism according to claim 9, wherein the object comprises an endotracheal tube.

17. The adjustable locking mechanism according to claim 16, wherein the endotracheal tube has a diameter in the range of 2 mm to 12 mm.

18. A method for securely fastening an extension device to a user, the method comprising: fixing a frame having a radially tracking portion about the user's head; sliding an adjustable locking mechanism along the radially tracking portion to a desired location; using the adjustable locking mechanism to lock the extension device in place and including.

19. The method according to claim 18, wherein the desired location is proximate to the user's mouth such that the extension device can advantageously be inserted into the user's mouth.

20. The method according to claim 19, wherein the extension device comprises an endotracheal tube.

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