WO2022066711A1

WO2022066711A1 - Oral splint with tracheal passage

Info

Publication number: WO2022066711A1
Application number: PCT/US2021/051473
Authority: WO
Inventors: Nathan Evans; Jacob PELOQUIN; Timothy GOVERT; Joseph B CHAPMAN; David B Powers
Original assignee: Duke University; Restor3D
Priority date: 2020-09-22
Filing date: 2021-09-22
Publication date: 2022-03-31

Abstract

The present disclosure describes an oral splint to prevent masticatory trauma to the lingual tissues during prolonged or prone surgical procedures or surgical procedures. It is useful for procedures utilizing neuromuscular monitoring that require frequent nerve stimulation, which causes mastication. The splint has a malleable flange that isolates the lingual tissues from oral trauma or pressure necrosis. The splint is designed to allow simultaneous use of an oral endotracheal tube.

Description

Oral Splint with Tracheal Passage

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63/081 ,377, filed September 22, 2020, the contents of which are entirely incorporated by reference herein.

BACKGROUND

[0002] There are wide variety of medical procedures that can cause collateral injury to the tongue. In particular, some types of neurological or spinal surgeries are known to cause a patient to masticate or unexpectedly clamp their jaw. This can in some cases cause unnecessary and sometimes irreparable damage to the patient's tongue. Current surgical recommendations include a minimal intervention of providing gauze in the patient's mouth. This is not only marginally effective but can also introduce other risks to the patient. Hence, there is an ongoing need for improved tongue protection during medical procedures.

SUMMARY

[0003] The Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

[0004] One aspect of the present disclosure provides an oral splint, comprising, consisting of, or consisting essentially of at least one upper support for mating with at least posterior upper teeth of a subject; a lower support for mating with lower teeth of the subject; and a center support between the at least one upper support and the lower support, the center support extending across a width of the lower support, where the center support and lower support create a cavity configured to isolate the subject's tongue from the upper and lower teeth, and whern the oral splint is configured to allow placement of an endotracheal tube while the splint is in use.

[0005] In some aspects, the oral splint comprises a first upper support and a second upper support. For example, an opening is formed between the first upper support and the second upper support to allow placement of the endotracheal tube.

[0006] In further aspects, the at least one upper support comprises a channel with a support surface and/or the lower support comprises a support surface.

[0007] In some embodiments, the splint comprises at least one interior passageway, where the interior passageway is optionally closed within the splint and provides distribution of compressive forces. The at least one interior passageway extends from the at least one upper support to the lower support through a separation section between the at least one upper support and the lower support. In some aspects, the at least one interior passageway is an air-filled cavity, and optionally, the at least one interior passageway is operable to be inflated or deflated to adjust the stiffness and strength of the oral splint. In additional aspects, the oral splint comprises two interior passageways, each interior passageway having an “L” shape with a substantially circular cross section.

[0008] In some embodiments, the upper and lower supports are offset from one another by a separation section, and wherein the separation section is configured to hold the upper and lower teeth at least approximately 5-10 mm apart.

[0009] In some embodiments, the center support area comprises a thinwalled, curved shape.

[0010] In some embodiments, the at least one upper support comprises a recessed area at the rear of splint, the recessed area having relatively thinner walls, which facilitate and absorb some compression force caused by biting or mastication.

[0011] Another aspect of the present disclosure provides a method of protecting a tongue during a surgical procedure using an oral splint as disclosed herein. The method may include placing a lower support of an oral splint on the lower teeth of the patient; and placing two upper supports of the oral splint on a portion of the upper teeth of the patient such that the tongue is constrained by a cavity formed by a lower surface of a center support and the lower support of the oral splint.

[0012] In some embodiments the method may further comprise inserting a medical device into the patient through an opening between the upper supports and above the center support. For example, the medical device is an endotracheal tube. [0013] In an embodiment, the method further comprises inflating or deflating at least one interior passageway of the oral splint to adjust the stiffness and/or the strength of the oral splint.

[0014] In various aspects, the oral splint provides a barrier between the patients tongue and teeth such that the tongue is protected if the patient compresses their teeth during a medical procedure.

[0015] Another aspect of the present disclosure provides all that is described and illustrated herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying Figures and Examples are provided by way of illustration and not by way of limitation. The foregoing aspects and other features of the disclosure are explained in the following description, taken in connection with the accompanying example figures (also “FIG.”) relating to one or more embodiments, in which:

[0017] FIG. 1A is a top perspective view of an oral splint in accordance with one embodiment of the present disclosure;

[0018] FIG. 1 B is a bottom perspective view of an oral splint in accordance with one embodiment of the present disclosure;

[0019] FIG. 2 is a top view of the oral splint shown in FIG. 1 ;

[0020] FIG. 3 is a bottom view of the oral splint shown in FIG. 1 ;

[0021] FIG. 4 is a back view of the oral splint shown in FIG. 1 ;

[0022] FIG. 5 is a front view of the oral splint shown in FIG. 1 ;

[0023] FIG. 6 is a side view of the oral splint shown in FIG. 1 ;

[0024] FIG. 7 is a perspective view of a wireframe drawing of the oral splint shown in FIG. 1 ;

[0025] FIG. 8 is a side view of a wireframe drawing of the oral splint shown in FIG. 1 ;

[0026] FIG. 9 is a front view of a wireframe drawing of the oral splint shown in FIG. 1 ;

[0027] FIG. 10 is a top view of a wireframe drawing of the oral splint shown in FIG. 1 ; [0028] FIG. 11 is a perspective view of the oral splint shown in FIG. 1 with a tubing attachment in accordance with one embodiment of the present disclosure.

DETAILED DESCRIPTION

[0029] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to preferred embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended, such alteration and further modifications of the disclosure as illustrated herein, being contemplated as would normally occur to one skilled in the art to which the disclosure relates.

[0030] Articles “a” and “an” are used herein to refer to one or to more than one (i.e. at least one) of the grammatical object of the article. By way of example, “an element” means at least one element and can include more than one element.

[0031 ] “About” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “slightly above” or “slightly below” the endpoint without affecting the desired result.

[0032] The use herein of the terms "including," "comprising," or "having," and variations thereof, is meant to encompass the elements listed thereafter and equivalents thereof as well as additional elements. As used herein, “and/or” refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as the lack of combinations where interpreted in the alternative (“or”).

[0033] As used herein, the transitional phrase "consisting essentially of" (and grammatical variants) is to be interpreted as encompassing the recited materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. Thus, the term "consisting essentially of" as used herein should not be interpreted as equivalent to "comprising."

[0034] Moreover, the present disclosure also contemplates that in some embodiments, any feature or combination of features set forth herein can be excluded or omitted. To illustrate, if the specification states that a complex comprises components A, B and C, it is specifically intended that any of A, B or C, or a combination thereof, can be omitted and disclaimed singularly or in any combination. [0035] Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. For example, if a concentration range is stated as 1 % to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1 % to 3%, etc., are expressly enumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this disclosure.

[0036] As used herein, the term "subject" and "patient" are used interchangeably herein and refer to both human and nonhuman animals. In some embodiments, the subject comprises a human who is undergoing a procedure while using a device as prescribed herein.

[0037] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0038] According to one aspect of the present disclosure, an oral splint for preventing tongue damage is described. The splint is particularly useful during surgical procedures which require intubation and which also are likely to cause biting or chewing by the patient. This combination can have an undesirable side effect, in which the patient causes damage to his or her own tongue while receiving treatment for an unrelated problem. The oral splint disclosed herein can prevent such damage, while at the same time allowing some freedom of movement of the tongue and jaw and also allowing the use of endotracheal devices. The splint, which can be referred to as a "Save-A-Tongue" oral splint, is designed to prevent masticatory trauma to the lingual tissues during prolonged or prone surgical procedures or surgical procedures utilizing neuromuscular monitoring requiring frequent nerve stimulation which causes mastication. Thus, the oral splint is configured to allow placement of an endotracheal tube while the splint is in use.

[0039] FIGS. 1A-1 B illustrate an oral splint 100 according to one embodiment of the present disclosure. Splint 100 comprises at least one upper support 102, a lower support 104, and a center support 106. These supports are designed to produce a combination of rigid and malleable areas that constrain possible positions of the mouth and jaw. For example, at least one upper support 102 may be configured for mating with at least posterior upper teeth of a subject, a lower support 104 may be configured for mating with lower teeth of the subject, and the center support 106 and lower support 104 create a cavity configured to isolate the subject's tongue from the upper and lower teeth. The splint 100 can be formed as a monolithic molded material that has some pliability (such as an oral-approved plastic). In an example, the oral splint 100 may be 3D printed. In some aspects, the material of the upper support 102 and the lower support 104 may differ from the material of the center support 106. The material and the geometric features allow the splint to have a limited range of compression.

[0040] Splint 100 can be provided in any suitable range of sizes to accommodate patients of all ages and mouth geometry. In various aspects, the oral splint 100 may have dimensions to fit an average sized mouth. In some embodiments, an oral splint 100 may be sized to fit an average man’s mouth, an average woman’s mouth, and/or an average child’s mouth. In some examples, the oral splint 100 may have a width from the left to right side of a subject’s mount ranging from about 5 cm to about 7 cm. In other examples, the oral splint 100 may have a height ranging from about 2.5 cm to about 4 cm. In additional examples, the oral splint 100 may have a depth ranging from about 3.5 cm to about 5.5 cm.

[0041] In the example embodiment of FIG. 1A, upper support 102 may include a first upper support 102a and a second upper support 102b. Each upper support 102 includes a channel-like resting surface 103 for the maxilla. The resting surface 103 has walls on two parallel sides to form the channel-like structure. The walls of the resting surface 103 may extend to a height that partially or fully covers the teeth that align with the support surface 103 of the upper support 102. This resting surface 103 is shortened in comparison to the lower support 104, with a facing surface 108 set back from the front of the splint. This allows the front upper teeth (e.g., anterior, incisors) to be exposed, and the rear upper teeth (e.g., posterior, molars) to rest on each upper support 102, thus creating an opening between the two upper supports 102 for an endotracheal tube or other device. This configuration also provides a clinician uninhibited access to the patient's mouth. Thus, an oral endotracheal tube to facilitate general anesthesia can be inserted with splint 100 in place. The splint advantageously prevents compression of the endotracheal tube, which could result in increased airway pressures or inhibition of vascular perfusion pressure of the tongue.

[0042] In an embodiment, at least one of the upper supports 102 may include at least one medical sensor. Non-limiting examples of medical sensors include sensors for the tongue, buccal surface, and base of tongue.

[0043] The upper supports 102 have a recessed area 110 at the rear of splint 100, with relatively thinner walls, which facilitate and absorb some compression force caused by biting or mastication. The upper supports 102 are separated, or offset, from lower support 104 by a separation section 112, which holds the patient's mouth slightly open, even during maximum compression. The thickness of the separation section 112 can be customized according to the size of the splint, designated use, patient age, etc. The thickness of separation section 112 may range from about 2 mm to about 15 mm. In some examples, the separation section 112 may be configured to hold the upper and lower teeth at least approximately 5-10 mm apart. In a non-limiting example, the thickness of separation section 112 can be designed to have a minimum thickness of approximately 7.5 mm while under compression.

[0044] Lower support 104 includes a channel 105 that covers substantially the entire mandible. The channel 105 has a resting surface 107 for supporting the lower teeth and has walls on two parallel sides to form the channel 105. The walls of the channel 105 may extend to a height that partially or fully covers the teeth that align with the resting surface 107 of the lower support 104. In some examples, the channel 105 may have a width ranging from about 1 cm to about 1.5 cm. The channel 105 has a curvature to substantially align with the curvature of the lower teeth. This isolates the lingual tissues from the teeth in order to prevent oral trauma or pressure necrosis. The lower support 104 is configured to fit a range of jaw geometries and to accommodate some limited lateral movement of the jaw. The full channel 105 also serves to isolate the tongue from the lower jaw. For example, the inner wall of the channel 105 may form a space for receiving the tongue. However, it is noted that it is also possible to omit at least some portions of the outer walls of lower support 104, and possibly all of the outer wall, without departing from the scope of the invention. [0045] In an embodiment, the lower support 104 may include at least one medical sensor. Non-limiting examples of medical sensors include sensors for the tongue, buccal surface, and base of tongue.

[0046] Center support 106 provides a barrier between the patient's tongue and the airway/endotracheal passage. The center support 106 may extend across a width of the lower support 104. In the example embodiment shown in FIGS. 1 -6, center support 106 is a solid surface that spans the area between the lateral sides of lower support 104. Alternately, it is possible that center support 106 can have additional features, such as holes, vents, or possibly guiding features for positioning an endotracheal tube. In an embodiment, the center support 106 is thin and flexible. In some embodiments, center support 106 is very pliable due to the relatively thinwalled (e.g., 2D) cross-sectional area compared to other portions of splint 100. This allows center support 106 to act as a sort of "trampoline" for the tongue. That is, the tongue can move relatively freely within the cavity 114 formed by center support 106 and lower support 104, and forces exerted by the tongue can be absorbed. In some embodiments, center support 106 has a smooth underside to avoid contact damage to the tongue. The center support 106 may have a curved shape. In the example embodiment shown, center support 106 has a sloping shape that rises upward toward the back of the splint. A medical device such as an endotracheal tube may be inserted into the patient when the oral splint 100 is in place and rest on an upper surface of the center support 106 and between the upper supports 102. The tongue remains isolated in the cavity 114 formed by the center support 106 and lower support 104.

[0047] In an embodiment, the center support 106 may include at least one medical sensor. Non-limiting examples of medical sensors include sensors for the tongue, buccal surface, and base of tongue.

[0048] FIGS. 2-6 depict additional views of oral splint 100. FIGS. 2 and 3 are top and bottom views of an oral splint 100, respectively. FIGS. 4 and 5 are front and rear views of an oral splint 100, respectively. FIG. 6 is a sectional side view of oral splint 100.

[0049] Referring now to FIGS. 7-10, additional details of splint 100 are shown. FIGS. 7-10 are wireframe drawings of splint 100 that show an optional interior feature, at least one interior passageway 120 to provide distribution of compressive forces. For example, an interior passageway 120 may extend from each upper support 102 to the lower support 104 through the separation section 112 between the upper support 102 and the lower support 104. In another example, an interior passageway 120 may be within the separation section 112 and/or the lower support 104. In nonlimiting aspects, the oral splint 100 includes at least one, at least two, at least three, or at least four interior passageways 120. In some examples, at least one interior passageway 120 may connect with another interior passageway and the one or more interior passageways 120 may be closed within the splint 100. In some embodiments, the at least one interior passageway 120 has a pillar or cylindrical shape. In the example embodiment of FIGS. 7-10, the interior passageways 120 have an "L" shape with a substantially circular cross section. However, interior passageway 120 can have any suitable shape and/or cross section. In some embodiments, the one or more pillars 120 can be completely confined to the interior of the splint as an air-filled cavity. This allows an external compressive load to be distributed to different parts of the splint. Interior passageway 120 can be produced, for example, by forming splint 100 in an additive manufacturing process, or by a post-processing step. The amount of air within the at least one interior passageway 120 may be adjustable to adjust the stiffness and/or the strength of the oral splint 100. The balance between stiffness and strength may depend on the specific patient, the procedure using the oral splint 100, the amount of compression needed, or other factors. In some embodiments the interior passageway 120 can be inflated or deflated with air either prior to or during use. In some embodiments, the amount of air in the interior passageway 120 may be adjusted using a syringe. The oral splint 100 may include a syringe access point for accessing the at least one interior passageway 120 or the material of the oral splint 100 may allow for a needle to be inserted at any position to access the interior passageway 120

[0050] Referring now to FIG. 11 , a tubing attachment 200 is shown attached to the oral splint 100. The tubing attachment 200 may be removable or may be integrally formed with the oral splint. The tubing attachment 200 is configured to be placed above the center support 106 and between the upper supports 102. The tubing attachment 200 provides support for an oral endotracheal tube or other device that is being used in conjunction with the oral splint 100.

[0051] The tubing attachment 200 includes a guide 202 configured to surround at least a portion of a tube being passed through the oral splint 100 and into the throat or airway of a patient. The guide 202 may include an upper portion 208 and a lower portion 210. In some embodiments, the upper portion 208 and the lower portion 210 may not connect. In other embodiments, the upper portion 208 and the lower portion 210 may connect at at least one location along the length of the guide 202. The upper portion 208 of the guide 202 may have a semi-circular cross-section and may be curved to substantially match the curve of a tube to be inserted in the guide 202. The lower portion 210 may be substantially flat to provide support for the tube to be inserted in the guide 202. For example, FIG. 11 shows a guide 202 with a curved upper portion 208 and a flat lower portion 210. In some aspects, the lower portion 210 may also have a semi-circular cross-section. In at least one embodiment, the upper portion 208 and the lower portion 210 may both be curved and connected, forming a cylindrical shape.

[0052] The tubing attachment 200 further includes an attachment mechanism 204 for connecting the tubing attachment 200 to the oral splint 100. The attachment mechanism 204 may be a clamp, clip, adhesive, or any other feature operable to connect the tubing attachment 200 to the oral splint 100. In various aspects, the attachment mechanism 204 may connect the tubing attachment 200 reversibly or permanently to the oral splint 100. In an example, the attachment mechanism 204 may contact the oral splint 100 at a side wall of the channel 105 of the lower support 104.

[0053] In some embodiments, the tubing attachment 200 may further include an extension 206. The extension 206 may be configured to further support the tubing going through the guide 202. In some aspects, the extension 206 may provide proper the tubing at a proper angle for being placed within the guide 202. In additional embodiments, the tubing attachment 200 may further include a movable portion.

[0054] In some embodiments, an endotracheal tube may be secured to the oral splint 100 without the need for the tubing attachment. In an example, an endotracheal tube may be reliably secured from moving in patients with natural or implanted teeth through the opening between the two upper supports 102 and the center support 106.

[0055] Another aspect of the present disclosure provides a method of protecting a tongue using the disclosed oral splint. The method may include placing the lower support of the oral splint on the lower teeth of the patient, placing the upper supports of the oral splint on a portion of the upper teeth of the patient such that the tongue is constrained by a cavity formed by a lower surface of a center support and the lower support of the oral splint. In some embodiments, the method may further include inserting a medical device into the patient, through the opening between the upper supports and above the center support. In additional embodiments, the method may further include guiding the medical device through the oral support using a tubing attachment. In yet further embodiments, the method may include inflating or deflating at least one interior passageway of the oral splint to adjust the stiffness and/or the strength of the oral splint. The oral splint provides a barrier between the patients tongue and teeth such that the tongue is protected if the patient compresses their teeth during a medical procedure.

[0056] Another aspect of the present disclosure provides all that is described and illustrated herein.

[0057] One skilled in the art will readily appreciate that the present disclosure is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The present disclosure described herein are presently representative of preferred embodiments, are exemplary, and are not intended as limitations on the scope of the present disclosure. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the present disclosure as defined by the scope of the claims.

[0058] No admission is made that any reference, including any nonpatent or patent document cited in this specification, constitutes prior art. In particular, it will be understood that, unless otherwise stated, reference to any document herein does not constitute an admission that any of these documents forms part of the common general knowledge in the art in the United States or in any other country. Any discussion of the references states what their authors assert, and the applicant reserves the right to challenge the accuracy and pertinence of any of the documents cited herein. All references cited herein are fully incorporated by reference, unless explicitly indicated otherwise. The present disclosure shall control in the event there are any disparities between any definitions and/or description found in the cited references.

Claims

CLAIMS What is claimed is:

1. An oral splint, comprising: at least one upper support for mating with at least posterior upper teeth of a subject; a lower support for mating with lower teeth of the subject; and a center support between the at least one upper support and the lower support, the center support extending across a width of the lower support, wherein the center support and lower support create a cavity configured to isolate the subject's tongue from the upper and lower teeth, and wherein the oral splint is configured to allow placement of an endotracheal tube while the splint is in use.

2. The oral splint of claim 1 , wherein the oral splint comprises a first upper support and a second upper support.

3. The oral splint of claim 2, wherein an opening is formed between the first upper support and the second upper support to allow placement of the endotracheal tube.

4. The oral splint of claim 1 , wherein the at least one upper support comprises a channel with a support surface.

5. The oral splint of claim 1 , wherein the lower support comprises a support surface.

6. The oral splint of claim 1 , further comprising at least one interior passageway.

7. The oral splint of claim 6, wherein the at least one interior passageway extends from the at least one upper support to the lower support through a separation section between the at least one upper support and the lower support.

8. The oral splint of claim 6, wherein the at least one interior passageway is closed within the oral splint and provides distribution of compressive forces.

9. The oral splint of claim 6, wherein the at least one interior passageway is an air-filled cavity.

10. The oral splint of claim 9, wherein the at least one interior passageway is operable to be inflated or deflated to adjust the stiffness and strength of the oral splint.

11. The oral splint of claim 6, wherein the oral splint comprises two interior passageways, each interior passageway having an “L” shape with a substantially circular cross section.

12. The oral splint of claim 1 , wherein the at least one upper support and the lower support are offset from one another by a separation section, and wherein the separation section is configured to hold the upper and lower teeth at least approximately 5-10 mm apart.

13. The oral splint of claim 1 , wherein the center support is thin-walled.

14. The oral splint of claim 13, wherein the center support has a curved shape.

15. The oral splint of claim 1 , wherein the at least one upper support comprises a recessed area at the rear of splint, the recessed area having relatively thinner walls, which facilitate and absorb some compression force caused by biting or mastication.

16. A method of protecting a tongue of a patient during a surgical procedure, the method comprising: placing a lower support of an oral splint on the lower teeth of the patient; and placing two upper supports of the oral splint on a portion of the upper teeth of the patient such that the tongue is constrained by a cavity formed by a lower surface of a center support and the lower support of the oral splint.

17. The method of claim 16, further comprising inserting a medical device into the patient through an opening between the upper supports and above the center support.

18. The method of claim 17, wherein the medical device is an endotracheal tube.

19. The method of claim 16, further comprising inflating or deflating at least one interior passageway of the oral splint to adjust the stiffness and/or the strength of the oral splint.

20. The method of claim 16, wherein the oral splint provides a barrier between the patients tongue and teeth such that the tongue is protected if the patient compresses their teeth during the surgical procedure.

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