WO2013096466A1

WO2013096466A1 - Mouth and dentition protection and airway, esophageal, and trachea access facilitation

Info

Publication number: WO2013096466A1
Application number: PCT/US2012/070652
Authority: WO
Inventors: Stephen R. MUECKE
Original assignee: Muecke Stephen R
Priority date: 2011-12-19
Filing date: 2012-12-19
Publication date: 2013-06-27

Abstract

An oral appliance and methods of it use for facilitating accessing a patient's airway, esophagus, and/or trachea and for protecting the patient from inadvertent injury during or as a result of such procedures.

Description

MOUTH AND DENTITION PROTECTION AND AIRWAY,

ESOPHAGEAL, AND TRACHEA ACCESS FACILITATION

FIELD OF THE INVENTION

[0001] This invention relates to oral appliances and methods for accessing a patient's airway, esophagus, and/or trachea and for protecting the patient from inadvertent injury during or as a result of such procedures.

BACKGROUND

[0002] A wide variety of emergency, medical, and other procedures require access to the body structures through a patient's mouth, including intubation, esophageal surgery, and other procedures. There is risk of injury during such procedures to the teeth and soft tissue structures and risk that the patient will close the jaws, creating injuries, interfering with the medical procedures, or both. Anesthesia and other procedures also often result in injuries such as those resulting when a patient bites his tongue. There is, therefore, a need for an appliance and methods for keeping the jaws open, protecting the patient from injury and facilitating the medical procedure.

SUMMARY

[0003] The terms "invention," "the invention," "this invention" and "the present invention" used in this patent are intended to refer broadly to all of the subject matter of this patent and the patent claims below. Statements containing these terms should be understood not to limit the subject matter described herein or to limit the meaning or scope of the patent claims below. Embodiments of the invention covered by this patent are defined by the claims below, not this summary. This summary is a high-level overview of various aspects of the invention and introduces some of the concepts that are further described in the Detailed Description section below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used in isolation to determine the scope of the claimed subject matter. The subject matter should be understood by reference to appropriate portions of the entire specification of this patent, any or all drawings and each claim.

[0004] Certain embodiments of the invention include an appliance for positioning within a patient's mouth to maintain separation between a patient's maxilla and mandible and a dental arch associated with each of the maxilla and mandible, the appliance comprising a tray for contact with one of the patient's dental arches and structure projecting differing distances from the tray for contact with the other of the patient's dental arches.

[0005] The tray may comprise a core composed of a semi-rigid or rigid material. The tray may also comprise a dental arch mating surface having an outer edge with a U-shaped design, as well as an inner edge having a U-shaped design. In certain embodiments, the dental arch mating surface further comprises a plate positioned interior of the outer edge. The tray may also comprise an outer shell having a lower bulk modulus and/or a liner made of an ISO 10993 or USP Class VI conforming material.

[0006] The structure may include a plurality of wedges that are configured to project in progressively increasing distances from the back of the patient's mouth to the front of the patient's mouth. The structure may also further comprise an outer shell having a lower bulk modulus and/or a liner made of an ISO 10993 or USP Class VI conforming material.

[0007] In certain embodiments, the appliance may further comprise a receptacle, wherein the receptacle is configured to couple to a retaining ring and/or at least one of equipment, sensors, or light sources.

[0008] The appliance may be used to maintain separation between a patient's maxilla and mandible and a dental arch associated with each of the maxilla and mandible via a method of (a) observing the size of the patient's upper or lower dental arch, (b) selecting an appliance comprising a tray having a dental arch mating surface with an outer edge appropriately sized for contact with one of the patient's dental arches and structure projecting differing distances from a dental arch spacing surface of the tray for contact with the other of the patient's dental arches, (c) manipulating the patient's mandible to separate it from the patient's maxilla, and (d) inserting the appliance within a patient's mouth. In some cases, the method may further comprise positioning the appliance with (i) one of the patient's dental arches in contact with the dental arch mating surface and (ii) the other of the patient's dental arches in contact with the projecting structure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a developmental computer model (rendering) depicting an appliance according to certain embodiments of the invention fitted in a 3-dimensional cone beam computed tomography ("CBCT") image or model of a typical adult oral cavity, holding a desired opening and angle between the mandible G^aw) ^and maxilla.

[0010] Figure 2 is a contour of the embodiment of the appliance shown in Figure 1 superimposed on a two-dimensional CBCT scan slice though dentition.

[0011] Figure 3 is a perspective view of an appliance according to certain embodiments of the invention showing the overall dimensions of the core and outer shell/lining and positioning "wedges."

[0012] Figure 4 is a perspective view of an appliance according to certain embodiments of the invention illustrating the composite construction of the core and shell/lining.

[0013] Figure 5 is a perspective view of an appliance according to certain embodiments of the invention illustrating a dental arch mating surface having a plate positioned interior of an outer edge. [0014] Figure 6 is a perspective view of an appliance according to certain embodiments of the invention illustrating the composite construction of the core and shell/lining and the location of a receptacle for coupling other items to the appliance.

DETAILED DESCRIPTION

[0015] The subject matter of embodiments of the present invention is described here with specificity to meet statutory requirements, but this description is not necessarily intended to limit the scope of the claims. The claimed subject matter may be embodied in other ways, may include different elements or steps, and may be used in conjunction with other existing or future technologies. This description should not be interpreted as implying any particular order or arrangement among or between various steps or elements except when the order of individual steps or arrangement of elements is explicitly described.

[0016] The described embodiments of the invention provide oral appliances for use with a patient's mouth. While the appliances are discussed for use in accessing a patient's airway, esophagus, and/or trachea, they are by no means so limited. Rather, embodiments of the appliances may be used for other applications within a patient's mouth or otherwise as desired.

[0017] The appliance and methods of this invention enable positioning an anatomically appropriate wedge-shaped tray lined with retentive material in the patient's mouth prior to general anesthetic, intubation, or other procedures or times when it is desirable to position the patient's mouth open while providing access to the esophagus, trachea, and other structures. The tray protects the dentition, soft tissue including the tongue, and the temporomandibular j oints .

[0018] The tray maintains the mouth in an open position without stress to the musculature and joints. The tray is disposable and can be made in various sizes to accommodate different size individuals. The tray sizes may be color coded and packaged for individual use.

[0019] A primary use will be during general anesthesia with endotracheal intubation.

[0020] One embodiment of the device may incorporate multiple materials molded into a composite structure tray.

[0021] According to certain embodiments of the invention, as best illustrated in

Figures 1-6, the appliance 10 may include a tray 12 shaped to provide a desired separation between upper 14 and lower 16 dental arches with a gap between teeth 18 and adjacent soft tissues 20 and fix the jaw (i.e., hold the patient's maxilla 22 and mandible 24 in a desired open position (as shown in Figure 1)). According to the embodiments described herein, the tray 12 may be a three-dimensional structure comprising a dental arch mating surface 40, an outer edge 44, and an inner edge 46, which together form a generally U-shaped channel, as illustrated in Figures 1-4 and 6. However, one of ordinary skill in the relevant art will understand that the tray 12 may have any suitable three-dimensional shape that allows the tray 12 to contact the upper 14 and/or lower 16 dental arches in a way that minimizes movement of the tray 12 relative to the upper 14 and/or lower 16 dental arches when pressure or other forces are applied to the tray 12 while the tray 12 is in contact with the upper 14 and/or lower 16 dental arches. The appliance 10 may further comprise a dental arch spacing surface 42, which may be positioned on a side of the appliance 10 that opposes the location of the tray 12.

[0022] As illustrated in Figure 1, the dental arch mating surface 40 may be configured to contact the upper dental arch 14. The appliance 10 may also be inverted so that the dental arch mating surface 40 of the tray 12 is configured to contact the lower dental arch 16. In other embodiments, two appliances 10 may be used, wherein the dental arch spacing surfaces 42 on each appliance 10 are shaped to mate with one another and provide a desired spacing between the upper 14 and lower 16 dental arches and a gap between the teeth 18 and the adjacent soft tissues 20 and fix the jaw.

[0023] The dental arch mating surface 40 includes the outer edge 44 having a U- shaped design that is configured to generally align with an outer edge of at least one of the dental arches 14 and 16. As illustrated in Figures 1-4 and 6, the dental arch mating surface 40 may also include the inner edge 46 having a U-shaped design that is configured to generally align with an inner edge of at least one of the dental arches 14 and 16. However, one of ordinary skill in the relevant art will understand that any suitable shape or configuration of the dental arch mating surface 40, the outer edge 44, and/or the inner edge 46 may be used that minimizes movement of the tray 12 relative to the upper 14 and/or lower 16 dental arches when pressure or other forces are applied to the tray 12 while the tray 12 is in contact with the upper 14 and/or lower 16 dental arches.

[0024] As illustrated in Figures 1-4 and 6, the dental arch mating surface 40 may include an open region 48 that is positioned interior of the inner edge 46. The open region 48 may be included so as to provide less restricted access to the patient's mouth, esophagus, and/or trachea.

[0025] Alternatively, as illustrated in Figure 5, the dental arch mating surface 40 may include a plate 50 that is positioned interior of the outer edge 44. The plate 50 may be flat, curved, or any other suitable shape. Use of the plate 50 (in lieu of the inner edge 46 and/or open region 48) allows the dental arch mating surface 40 to align with a wider range of angles in dental arches 14 and 16. Thus, the same sized tray 12 may be used in combination with a variety of mouth sizes because the interior region of the dental arch mating surface 40 is not restricted to a particular dental arch shape.

[0026] As best illustrated in Figures 4 and 6, the tray 12 may have a core composed of a semi-rigid or rigid material to retain the shape of the tray under loading during placement in the mouth and while retained in the mouth. An outer shell 26 or full or partial liner of lower bulk modulus and lower hardness provides compliance needed for protecting the dentition and soft tissues from damage or abrasion, while also providing sufficient static friction with contact surfaces of patient anatomy to restrict mobility of the tray in the oral cavity. Outer shell and/or lining materials may be an ISO 10993 or USP Class VI conforming material.

[0027] A plurality of angled or straight contact structures 36, such as wedges 28, 30,

32, and 34, project from the dental arch spacing surface 42 of the appliance 10 for contact with the opposing dentition 38 to retain the appliance 10 in position and maintain a desired angle and/or spacing between the dental arches 14 and 16, as well as a desired position of the mandible 24 relative to the maxilla 22. For example, the structures 36 may project at differing distances from the dental arch spacing surface 42. Specifically, the structures 36 may project in progressively increasing distances along the dental arch spacing surface 42 from the back of the patient's mouth to the front of the patient's mouth.

[0028] Other contact structures 36 than the illustrated wedges 28, 30, 32, and 34 are possible and may be desirable depending on whether the patient has all of his or her teeth and other considerations. For instance, fewer or more wedges may be used; the separation of the wedges may be changed; and the wedges may combined, in effect substituting a single sloping structure for the four wedges 28, 30, 32, and 34. The specific geometry of this structure 36 of the appliance 10 may cause the appliance 10 to be more or less effectively retained in the desired position in a particular patient.

[0029] As described above with respect to the tray 12 and illustrated in Figures 4 and

6, the structures 36, such as the wedges 28, 30, 32, and 34, may have a core composed of a semi-rigid or rigid material to retain the shape of the structures 36 under loading during placement in the mouth and while retained in the mouth. An outer shell 52 or full or partial liner of lower bulk modulus and lower hardness provides compliance needed for protecting the dentition and soft tissues from damage or abrasion, while also providing sufficient static friction with contact surfaces of patient anatomy to restrict mobility of the tray in the oral cavity. Outer shell and/or lining materials may be an ISO 10993 or USP Class VI conforming material.

[0030] As illustrated in Figure 6, the appliance 10 may be further configured to retain, immobilize, and/or facilitate the use of equipment within the patient's mouth, esophagus, and/or trachea. For example, the appliance 10 may further comprise a receptacle 54 that is configured to couple to a retaining ring and/or other suitable structures, or to couple directly to the equipment itself, either before or after the appliance 10 has been positioned within the patient's mouth. One of ordinary skill in the relevant art will understand that any suitable mechanical fasteners may be used to couple these devices to the receptacle 54 including but not limited to quick release pins, screws, bolts, snap-fit designs, or other suitable fasteners. The receptacle 54 coupling may be suitable for use with tubing, lumens, probes, catheters, guide wires, surgical instruments, or other structures.

[0031] The appliance 10 may be further configured to incorporate, mount, and/or position the use of sensors or other monitoring devices within the patient's mouth, esophagus, and/or trachea. Specifically, the receptacle 54 may be configured to couple to a retaining ring and/or other suitable structures, or to couple directly to the sensor or other monitoring device itself, either before or after the appliance 10 has been positioned within the patient's mouth. The receptacle 54 coupling may be suitable for use with sensors or other monitoring devices such as temperature, blood pressure, compressive force, heart rate, breathing rate, and other sensors.

[0032] The appliance 10 may be further configured to incorporate, mount, and/or position a light emitting diode or other light sources within the patient's mouth, esophagus, and/or trachea. Specifically, the receptacle 54 may be configured to couple to a retaining ring and/or other suitable structures, or to couple directly to the light emitting diode or other light sources, either before or after the appliance 10 has been positioned within the patient's mouth. Such light emitting diode or other light sources may be used to facilitate visualization of adjacent anatomy.

[0033] The appliance 10 may be further configured to incorporate markings for anatomical reference and/or measurement purposes. For example, the tray 12 may include markings to indicate when each tray 12 has been properly positioned within the patient's mouth by indicating the location along the tray that should be aligned with particular anatomical reference points. Likewise, the tray 12 may include markings that may be used to determine when particular areas of the patient's mouth are or are not in line with standard measurements for those areas.

[0034] In certain embodiments, the appliance 10 may also be used for weight training and/or resistance training. In these embodiments, the appliance 10 provides a cushion between the patient's maxilla 22 and mandible 24 and dental arches 14 and 16 associated therewith to allow a person to apply more pressure when lifting weights or training, thereby allowing that person to lift more weight and/or overcome greater resistance than would otherwise be possible without the appliance 10 in place.

[0035] The appliance 10 is used to maintain separation between the patient's maxilla

22 and mandible 24 and dental arches 14 and 16 associated therewith by selecting an appliance 10 appropriate for the size of the patient's maxilla 22 and/or mandible 24, separating the patient's maxilla 22 and mandible 24, and inserting the appliance 10 into the patient's mouth until it seats against the upper 14 and lower 16 dental arches so that the maxilla and mandible are appropriately separated and the appliance 10 is retained in contact with the dental arches 14 and 16. The appliance may also be used by coupling at least one of equipment, sensors, or light sources to the receptacle 54 that is coupled to the appliance 10.

[0036] Different arrangements of the components depicted in the drawings or described above, as well as components and steps not shown or described are possible. Similarly, some features and sub-combinations are useful and may be employed without reference to other features and sub-combinations. Embodiments of the invention have been described for illustrative and not restrictive purposes, and alternative embodiments will become apparent to readers of this patent. Accordingly, the present invention is not limited to the embodiments described above or depicted in the drawings, and various embodiments and modifications can be made without departing from the scope of the claims below. For example, the core of the tray 12 and/or the structures 36 may be formed of metals, plastics, composites, or other suitable materials that provide a suitable amount of rigidity to the tray.

Claims

1. An appliance for positioning within a patient's mouth to maintain separation between a patient's maxilla and mandible and a dental arch associated with each of the maxilla and mandible, the appliance comprising:

(a) a tray for contact with one of the patient's dental arches; and

(b) structure projecting differing distances from the tray for contact with the other of the patient's dental arches.

2. The appliance of claim I, wherein the tray comprises a core composed of a semi-rigid or rigid material.

3. The appliance of claim I, wherein the tray comprises a dental arch mating surface having an outer edge with a U-shaped design.

4. The appliance of claim 3, wherein the dental arch mating surface further comprises an inner edge having a U-shaped design.

5. The appliance of claim 3, wherein the dental arch mating surface further comprises a plate positioned interior of the outer edge.

6. The appliance of claim 1 , wherein the tray further comprises an outer shell having a lower bulk modulus.

7. The appliance of claim 1, wherein the tray further comprises a liner made of an ISO 10993 or USP Class VI conforming material.

8. The appliance of claim 1, wherein the structure comprises a plurality of wedges that are configured to project in progressively increasing distances from the back of the patient's mouth to the front of the patient's mouth.

9. The appliance of claim 1, wherein the structure further comprises an outer shell having a lower bulk modulus.

10. The appliance of claim 1, wherein the structure further comprises a liner made of an ISO 10993 or USP Class VI conforming material.

11. The appliance of claim 1, further comprising a receptacle.

12. The appliance of claim 1 1, wherein the receptacle is configured to couple to a retaining ring.

13. The appliance of claim 1 1, wherein the receptacle is configured to couple to at least one of equipment, sensors, or light sources.

14. A method for maintaining separation between a patient's maxilla and mandible and a dental arch associated with each of the maxilla and mandible, the method comprising:

(a) observing a size of the patient's upper or lower dental arch; (b) selecting an appliance comprising a tray having a dental arch mating surface with an outer edge appropriately sized for contact with one of the patient's dental arches and structure projecting differing distances from a dental arch spacing surface of the tray for contact with the other of the patient's dental arches;

(c) manipulating the patient's mandible to separate it from the patient's maxilla; and

(d) inserting the appliance within a patient's mouth.

15. The method of claim 14, further comprising positioning the appliance with:

(i) one of the patient's dental arches in contact with the dental arch mating surface; and

(ii) the other of the patient's dental arches in contact with the projecting structure.

16. The method of claim 15, wherein the appliance further comprises a receptacle.

17. The method of claim 16, further comprising coupling at least one of equipment, sensors, or light sources to the receptacle.

18. The method of claim 14, wherein the outer edge of the dental arch mating surface comprises a U-shaped design.

19. The method of claim 18, wherein the dental arch mating surface further comprises an inner edge having a U-shaped design.

20. The method of claim 18, the dental arch mating surface further comprises positioned interior of the outer edge.