Endotracheal tube holder, and method for stabilizing and securing an endotracheal tube at the mouth of a patient

Abstract

An endotracheal tube holder is adapted for stabilizing and securing an endotracheal tube at a mouth of a patient. The endotracheal tube holder incorporates an intraoral mouth prop, an integrated bite block, and extraoral body portion. The intraoral mouth prop has an upper member configured to engage an anterior roof of the mouth, and a lower member configured to engage an anterior floor of the mouth. The integrated bite block is formed adjacent the intraoral mouth prop and is configured to prevent tube occlusion caused by patient biting. The extraoral body portion is formed adjacent the bite block and defines an anchor point at which the endotracheal tube is releasably attached to the endotracheal tube holder.

Description

ENDOTRACHEAL TUBE HOLDER, AND METHOD FOR STABILIZING AND SECURING AN ENDOTRACHEAL TUBE AT THE MOUTH OF A PATIENTTechnical Field and Background of the Disclosure

[0001] The present disclosure relates broadly and generally to medical airway devices, and more specifically to an intraoral endotracheal tube holder and method for stabilizing and securing an endotracheal tube at the mouth of a patient. In exemplary embodiments, the invention eliminates the need for facial adhesives and improves clinician control, safety, and patient comfort.

[0002] Endotracheal tube holders are generally known the art and commonly used to stabilize and secure an endotracheal tube after intubation. The holder helps maintain the tube in the correct position for continuous mechanical ventilation. Its primary purpose is to keep the endotracheal tube from moving or becoming dislodged. By firmly anchoring the tube, these holders reduce the risk of accidental extubation, tube migration, and associated complications such as hypoventilation, aspiration, or respiratory arrest. Tube holders also help minimize device-related pressure injuries and skin breakdown around the lips and face by distributing pressure and avoiding harsh adhesive tapes. They also facilitate oral care and repositioning of the tube, which supports prevention of ventilator associated pneumonia and improves overall patient comfort in critical care settings.Summary of Exemplary Embodiments

[0003] Various exemplary embodiments of the present disclosure are described below. Use of the term "exemplary" means illustrative or by way of example only, and any reference herein to "the invention" is not intended to restrict or limit the invention to exact features or steps of any one or more of the exemplary embodiments disclosed in the present specification. References to "exemplary embodiment," "one embodiment," "an embodiment," "various embodiments," and the like, may indicate that the embodiment(s) of the invention so described may include a particular — 1633 / 1PCT Page 1-feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase "in one embodiment," or "in an exemplary embodiment," do not necessarily refer to the same embodiment, although they may.

[0004] It is also noted that terms like "preferably", "commonly", and "typically" are not utilized herein to limit the scope of the claimed invention or to imply that certain features are critical, essential, or even important to the structure or function of the claimed invention. Rather, these terms are merely intended to highlight alternative or additional features that may or may not be utilized in a particular embodiment of the present invention.

[0005] According to one exemplary embodiment, the present disclosure comprises an endotracheal tube holder adapted for stabilizing and securing an endotracheal tube at a mouth of a patient. The endotracheal tube holder incorporates an intraoral mouth prop, an integrated bite block, and extraoral body portion. The intraoral mouth prop has an upper member configured to engage an anterior roof of the mouth, and a lower member configured to engage an anterior floor of the mouth. The integrated bite block is formed adjacent the intraoral mouth prop and is configured to prevent tube occlusion caused by patient biting. The extraoral body portion is formed adj acent the bite block and defines an anchor point at which the endotracheal tube is releasably attached to the endotracheal tube holder.

[0006] According to another exemplary embodiment, the upper member of the intraoral mouth prop is arcuately shaped at its top surface to ergonomically engage and substantially conform to the roof of the mouth.

[0007] According to another exemplary embodiment, the upper member of the intraoral mouth prop is configured to curve rearwardly from the anterior roof of the mouth (e.g., directly behind the top— 1633 / 1PCT Page 2-front teeth) towards a posterior roof of the mouth.

[0008] According to another exemplary embodiment, the lower member of the intraoral mouth prop is rearwardly turned to ergonomically engage the anterior floor of the mouth (e.g., directly behind the bottom front teeth).

[0009] According to another exemplary embodiment, a flexible tube strap is adapted for releasably attaching the endotracheal tube to the extraoral body portion of the holder. The exemplary tube strap allows quick and easy side-to-side adjustments of the endotracheal tube without disrupting connection, while also reducing oral pressure injuries. In other exemplary embodiments, instead of (or in addition to) a flexible tube strap, the extraoral body portion of the holder may comprise or incorporate a clamp or other anchor mechanism designed to releasably engage the endotracheal tube outside the mouth.

[0010] According to another exemplary embodiment, the flexible tube strap comprises a one-way ratchet strap having a series of raised teeth configured to engage a catch (or pawl) formed with the extraoral body portion at a selected tension. The exemplary catch may be resiliently-formed with the body portion and configured to be manually lifted to temporarily disengage and release the ratchet strap. The tightened ratchet strap keeps endotracheal tube anchored in place to limit distal or proximal migration, and helps prevent lip and tongue ulcers while providing ready access inside mouth.

[0011] According to another exemplary embodiment, a proximal end of the flexible tube strap is held in a first slot formed at a bottom of the extraoral body portion, and a free end of flexible strap extends through a second open-access slot formed at a top of the extraoral body portion.

[0012] According to another exemplary embodiment, an angled guide is located at the top of the— 1633 / 1PCT Page 3-extraoral body portion to facilitate insertion and removal of the free end of the flexible tube strap into and from the second open-access slot formed in the extraoral body portion.

[0013] According to another exemplary embodiment, a circumferential head strap is adapted for further stabilizing and securing the endotracheal tube at the mouth of the patient. The exemplary head strap comfortably distributes tension around the head / neck of the patient.

[0014] According to another exemplary embodiment, a strap connector is secured to a button post located at a top of the extraoral body portion, and has fastener rings (e.g., square rings, D-rings or O-rings) at respective opposite ends.

[0015] According to another exemplary embodiment, the head strap has opposite free ends configured for releasable attachment to the fasteners rings of the strap connector.

[0016] According to another exemplary embodiment, the opposite free ends of the head strap extend through respective fastener rings of the strap connector and have respective portions of complementary hook and loop fasteners. Using the hook and loop fasteners at each strap end, the head strap can be selectively size-adjusted to gently and securely fit a head / neck of the patient.

[0017] According to another exemplary embodiment, the intraoral mouth prop is generally C-shaped to engage the roof and floor of the mouth, thereby limiting jaw movement and cooperating with the integrated bite block to prevent the patient from biting down onto the endotracheal tube. The term “generally C-shaped” is broadly defined herein to mean any structure which has a generally curved portion and top and bottom ends which cooperate form an open side. The top and bottom ends may be structurally different or substantially identical.Brief Description of the Drawings

[0018] Exemplary embodiments of the present disclosure will hereinafter be described in— 1633 / 1PCT Page 4-conjunction with the following drawing figures, wherein like numerals denote like elements, and wherein:

[0019] Figures 1 and 2 are perspective views of an endotracheal tube holder according to one exemplary embodiment of the present disclosure;

[0020] Figure 3 is an exploded perspective view showing the endotracheal tube holder, head strap and tube strap disassembled;

[0021] Figures 4 and 5 are assembled perspective views of the endotracheal tube holder, head strap and tube strap; and

[0022] Figure 6 is an environmental view of the exemplary endotracheal tube holder used by an intubated patient.Description of Exemplary Embodiments and Best Mode

[0023] The present invention is described more fully hereinafter with reference to the accompanying drawings, in which one or more exemplary embodiments of the invention are shown. Like numbers used herein refer to like elements throughout. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be operative, enabling, and complete. Accordingly, the particular arrangements disclosed are meant to be illustrative only and not limiting as to the scope of the invention, which is to be given the full breadth of the appended claims and any and all equivalents thereof. Moreover, many embodiments, such as adaptations, variations, modifications, and equivalent arrangements, will be implicitly disclosed by the embodiments described herein and fall within the scope of the present invention.

[0024] Although specific terms are employed herein, they are used in a generic and descriptive sense— 1633 / 1PCT Page 5-only and not for purposes of limitation. Unless otherwise expressly defined herein, such terms are intended to be given their broad ordinary and customary meaning not inconsistent with that applicable in the relevant industry and without restriction to any specific embodiment hereinafter described. As used herein, the article "a" is intended to include one or more items. Where only one item is intended, the term "one", "single", or similar language is used. When used herein to join a list of items, the term "or" denotes at least one of the items, but does not exclude a plurality of items of the list.

[0025] For exemplary methods or processes of the invention, the sequence and / or arrangement of steps described herein are illustrative and not restrictive. Accordingly, it should be understood that, although steps of various processes or methods may be shown and described as being in a sequence or temporal arrangement, the steps of any such processes or methods are not limited to being carried out in any particular sequence or arrangement, absent an indication otherwise. Indeed, the steps in such processes or methods generally may be carried out in various different sequences and arrangements while still falling within the scope of the present invention.

[0026] Additionally, any references to advantages, benefits, unexpected results, or operability of the present invention are not intended as an affirmation that the invention has been previously reduced to practice or that any testing has been performed. Likewise, unless stated otherwise, use of verbs in the past tense (present perfect or preterit) is not intended to indicate or imply that the invention has been previously reduced to practice or that any testing has been performed.

[0027] Referring now specifically to the drawings, an endotracheal tube holder according to one exemplary embodiment of the present disclosure is illustrated in Figures 1 and 2 and shown generally at broad reference numeral 10. The exemplary tube holder 10 cooperates with a flexible— 1633 / 1PCT Page 6-and adjustable tube strap 11 and circumferential head strap 12, as demonstrated in Figure 6, to stabilize and secure an endotracheal tube “T” at the mouth of a patient. Attachment of the tube holder 10 and the straps 11, 12 is discussed in further detail below.

[0028] As best shown in Figures 1 and 2, the present tube holder 10 incorporates a soft and rigid intraoral mouth prop 20, a soft integrated bite block 22, and an extraoral body portion 25. The intraoral mouth prop 20 is generally C-shaped, and comprises an arcuate cushioned upper member 31 and a vertically spaced cushioned lower member 32. The upper member 31 is curved along a slightly deformable top surface 31 A to ergonomically engage and substantially conform to the roof of the mouth. When the mouth prop 20 is correctly positioned, as shown in Figure 6, the upper member 31 curves rearwardly from the anterior roof of the mouth directly behind the top front teeth towards the posterior roof of the mouth. The lower member 32 has a rearwardly-turned bottom surface 32A configured to slightly deform and ergonomically engage the anterior floor of the mouth directly behind the bottom front teeth of the patient. The open space between the upper and lower members 31, 32 establishes a substantially clear pathway for intubation, allowing the tube “T” to comfortably pass into the mouth of the patient, over / around the tongue and down the throat. In the exemplary mouth prop 20, the vertical distance “V” between the top arcuate surface 31 A of upper member 31 (measured at its apex) and the bottom rearwardly-turned surface 32A of lower member 32 is approximately 1.90 inches, and between 1.5 and 2.5 inches.

[0029] The integrated bite block 22 is formed adjacent the intraoral mouth prop 20 and is configured to prevent the patient from biting down on the tube “T” when intubated. In exemplary embodiments, the bite block 22 has a length “L” of approximately 1.25 inches (and between 1.0 and 2.0 inches), a height “H” of approximately 0.85 inches (and between 0.5 and 1.50 inches), and a width “W” of— 1633 / 1PCT Page 7-approximately 0.25 inches (and between 0.20 and 1.0 inches).

[0030] Referring to Figures 1-5, the extraoral body portion 25 of the tube holder 10 is formed adjacent the bite block 22 and comprises various structural features defining anchor points for releasably securing the endotracheal tube “T”, flexible tube strap 11, and adjustable circumferential head strap 12. In the exemplary embodiment, a button post 41 is located at the top 42 of the extraoral body portion 25, above and adjacent a top front-access strap slot 44. An angled guide 45 is located at a front horizontally-formed opening of the top strap slot 44. A bottom front-access strap slot 46 is horizontally formed at a bottom 47 of the extraoral body portion 25 and in substantial vertical alignment with the top strap slot 44. The extraoral body portion 25 has a slightly curved and silicone-textured tube side 25A designed to closely receive the endotracheal tube “T”, and an opposite side 25B comprising a rearward-access strap retainer 48. The silicone texture 49 of tube side 25Africtionally engages the endotracheal tube “T” and helps limit unintended migration during intubation. In alternative embodiments, other high-friction texture on the tube side 25A may be created by rubber detents, rubber over-molding, or other such surface texturing.

[0031] As best shown in Figures 3, 4, and 5, the exemplary tube strap 11 comprises a flexible ratchet strap having an enlarged proximal stop 51, an inwardly spaced shoulder 52, a series of raised closely-spaced teeth 54, and a distal pull 55. The tube strap 11 is installed by inserting its proximal end though the front horizontally-formed opening of the bottom strap slot 46, thereby positioning the body portion 25 between the proximal stop 51 and strap shoulder 52. The proximal stop 51 prevents the tube strap 11 from being inadvertently detached from the body portion 25 when tightened. With endotracheal tube “T” positioned directly against the textured side 25A of body portion 25, the distal end of the tube strap 11 is lifted upwardly around the tube “T”, and inserted— 1633 / 1PCT Page 8-though the top front-access strap slot 44 of the body portion 25. The top 42 of body portion 25 has a downward-projecting catch 56 designed to engage the raised teeth 54 of the tube strap 11 , such that the tube strap 11 is selectively tightened against the tube “T” by grasping and gently pulling the distal pull 55. The exemplary catch 56 may be resiliently-formed with the body portion 25 and configured to be manually lifted to temporarily disengage and release the tube strap 11. The raised teeth 54 and catch 56 cooperate to enable one-way (and one-hand) adjustment of the flexible tube strap 11 to the desired holding tension. The free distal pull 55 is then tucked into the rearward-access strap retainer 48. The tightened strap 11 keeps the endotracheal tube “T” anchored in place to limit unintended migration, and may help reduce lip and tongue ulcers. The forward-angled guide 45 at the top 42 of body portion 25 facilitates one-hand insertion and removal of the tube strap 11 into and from the top slot 44. Tn other exemplary embodiments, instead of (or in addition to) a flexible tube strap 11, the extraoral body portion 25 of holder 10 may comprise or incorporate a clamp, adhesive tape, or other anchor mechanism designed to releasably engage the endotracheal tube outside the mouth.

[0032] The circumferential head strap 12 is indirectly attached to the extraoral body portion 25 using a flexible strap connector 61. The strap connector 61 is secured to the top button post 41 at slit 61 A and has fastener rings 62 (e.g., square rings, D-rings or O-rings) at respective opposite ends. The exemplary head strap 12 has opposite free ends 12A, 12B, each with complementary sections of hook and loop fasteners 65, 66. The free ends 12A, 12B of the head strap 12 extend through respective fastener rings 62 of the strap connector 61, and using the hook and loop fasteners 65, 66 at each strap end 12A, 12B, the head strap 12 can be selectively size-adjusted to securely fit the patient. When properly applied, the exemplary head strap 12 further stabilizes and secures the— 1633 / 1PCT Page 9-endotracheal tube“T” at the mouth of the patient, while comfortably distributing tension around the head / neck.

[0033] All parts of the exemplary endotracheal tube holder 10 may be formed together (e.g., molded) as a single integrated unit, or formed separately with exchangeable, disposable and / or reusable components. Soft exterior surfaces of the intraoral mouth prop 20 and bite block 22 may comprise medical grade silicone or rubber pads, silicone or rubber overmold, or silicone or rubber covering. The exemplary endotracheal tube holder 10 may comprise only one or both of the tube and head straps 11, 12, and may be temporarily secured to the tube “T” and patient by a variety of alternative means including adhesive tape and clamps.

[0034] For the purposes of describing and defining the present invention it is noted that the use of relative terms, such as "substantially", "generally", "approximately", and the like, are utilized herein to represent an inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0035] Exemplary embodiments of the present invention are described above. No element, act, or instruction used in this description should be construed as important, necessary, critical, or essential to the invention unless explicitly described as such. Although only a few of the exemplary embodiments have been described in detail herein, those skilled in the art will readily appreciate that many modifications are possible in these exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the appended claims.— 1633 / 1PCT Page 10-

[0036] In the claims, any means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents, but also equivalent structures. Thus, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface, in the environment of fastening wooden parts, a nail and a screw may be equivalent structures. Unless the exact language "means for" (performing a particular function or step) is recited in the claims, a construction under 35 U.S.C. §112(f) [or 6th paragraph / pre-AIA] is not intended. Additionally, it is not intended that the scope of patent protection afforded the present invention be defined by reading into any claim a limitation found herein that does not explicitly appear in the claim itself.— 1633 / 1PCT Page 11-

Claims

What is Claimed:

1. An endotracheal tube holder adapted for stabilizing and securing an endotracheal tube at a mouth of a patient, said endotracheal tube holder comprising:an intraoral mouth prop comprising an upper member configured to engage an anterior roof of the mouth, and a lower member configured to engage an anterior floor of the mouth;an integrated bite block adjacent said intraoral mouth prop and configured to prevent tube occlusion; andan extraoral body portion adjacent said bite block and comprising an anchor point at which the endotracheal tube is releasably attached to said endotracheal tube holder.

2. The endotracheal tube holder according to Claim 1, wherein the upper member of said intraoral mouth prop is arcuately shaped to ergonomically engage and conform to the roof of the mouth.

3. The endotracheal tube holder according to Claim 1, wherein the upper member of said intraoral mouth prop is configured to curve rearwardly from the anterior roof of the mouth towards a posterior roof of the mouth.— 1633 / 1PCT Page 12-4. The endotracheal tube holder according to Claim 1, wherein the lower member of said intraoral mouth prop is rearwardly-tumed to ergonomically engage the anterior floor of the mouth.

5. The endotracheal tube holder according to Claim 1, and comprising a flexible tube strap adapted for releasably attaching the endotracheal tube to said extraoral body portion.

6. The endotracheal tube holder according to Claim 5, wherein said flexible tube strap comprises a one-way ratchet strap having a series of raised teeth configured to engage a catch formed with said extraoral body portion at a selected tension, and wherein said catch is resiliently-formed with said body portion and configured to be manually lifted to temporarily disengage and release said ratchet strap.

7. The endotracheal tube holder according to Claim 5, wherein a proximal end of said flexible tube strap is held in a first slot formed at a bottom of said extraoral body portion, and a free end of said flexible strap extends through a second open-access slot formed at a top of said extraoral body portion.— 1633 / 1PCT Page 13-8. The endotracheal tube holder according to Claim 7, and comprising an angled guide located at the top of said extraoral body portion to facilitate insertion and removal of the free end of said flexible tube strap into and from the second open-access slot formed in said extraoral body portion.

9. The endotracheal tube holder according to Claim 1, and comprising a circumferential head strap adapted for further stabilizing and securing the endotracheal tube at the mouth of the patient.

10. The endotracheal tube holder according to Claim 9, and comprising a strap connector secured to a button post located at a top of said extraoral body portion, and comprising fastener rings at respective opposite ends.

11. The endotracheal tube holder according to Claim 10, wherein said head strap has opposite free ends configured for releasable attachment to the fasteners rings of said strap connector.

12. The endotracheal tube holder according to Claim 11, wherein the opposite free ends of said head strap extend through respective fastener rings of said strap connector and comprise respective portions of hook and loop fasteners, such that said head strap can be selectively size-adjusted to securely fit a head / neck of the patient.— 1633 / 1PCT Page 14-13. The endotracheal tube holder according to Claim 1, wherein said intraoral mouth prop is generally C-shaped.

14. An endotracheal tube holder adapted for stabilizing and securing an endotracheal tube at a mouth of a patient, said endotracheal tube holder comprising:a generally C-shaped intraoral mouth prop comprising an arcuate upper member configured to ergonomically engage an anterior roof of the mouth, and a lower member rearwardly turned to ergonomically engage an anterior floor of the mouth;an integrated bite block adjacent said intraoral mouth prop and configured to prevent tube occlusion; andan extraoral body portion adjacent said bite block and comprising an anchor point at which the endotracheal tube is releasably attached to said endotracheal tube holder.

15. The endotracheal tube holder according to Claim 14, and comprising a flexible tube strap adapted for releasably attaching the endotracheal tube to said extraoral body portion.— 1633 / 1PCT Page 15-16. The endotracheal tube holder according to Claim 15, wherein said flexible tube strap comprises a one-way ratchet strap having a series of raised teeth configured to engage a catch formed with said extraoral body portion at a selected tension.

17. The endotracheal tube holder according to Claim 15, wherein a proximal end of said flexible tube strap is held in a first slot formed at a bottom of said extraoral body portion, and a free end of said flexible strap extends through a second open-access slot formed at a top of said extraoral body portion.

18. The endotracheal tube holder according to Claim 17, and comprising an angled guide located at the top of said extraoral body portion to facilitate insertion and removal of the free end of said flexible tube strap into and from the second open-access slot formed in said extraoral body portion.

19. The endotracheal tube holder according to Claim 14, and comprising a flexible strap connector secured to a button post located at a top of said extraoral body portion, and comprising fastener rings at respective opposite ends.— 1633 / 1PCT Page 16-20. The endotracheal tube holder according to Claim 19, and comprising a circumferential head strap having opposing free ends configured for releasable and size-adjustable attachment to the fasteners rings of said strap connector.— 1633 / 1PCT Page 17-

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