Perioral respiration monitoring device

Abstract

A device is provided that enables continuous and unobstructed sampling of CO2 exhaled by a patient and administration of O2 to the patient while allowing unobstructed surgical or instrumental use or access of the patient's oral cavity and related areas.

Description

[0001] Identification of the parties involved

[0002] The inventors of the invention described in this patent document are Andreia Trigo of London, UK, Martin Lees of London, UK, Craig Cook of La Croix / Lutry, Switzerland, and Philippe Margairaz of La Chaux-de-Fonds, Switzerland.

[0003] The applicant for this intellectual property matter is SedateUK Ltd. of London, UK.

[0004] At the time of filing the application, John B. Moetteli of Switzerland and Da Vinci Partners LLC represented the applicant.

[0005] Copyright & Legal Notice

[0006] Part of the disclosure of this patent document contains copyrighted material. The applicant does not oppose the reproduction by anyone of the patent document or patent disclosure as it appears in the Patent and Trademark Office patent files or records, but reserves all copyright rights otherwise. Additionally, the citation of third party patents or articles in this document should not be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention. Background Art

[0007] For example, it is known that when a dentist treats a patient for periodontal disease, the mouth needs to be kept open during the treatment in order to provide optimal surgical access. Accordingly, different perioral retention devices are known. Summary of the Invention

[0008] It is an object of the present invention to develop a device as claimed in the appended claims for providing optimal surgical access, delivering supplementary oxygen and continuously monitoring inhaled and exhaled gases. This object is met by a perioral retention device adapted to keep the patient's oral cavity open to allow the patient to breathe through the oral cavity and / or through one or both of the patient's nostrils, the retention device comprising: an expandable inner flange and an expandable outer flange, the outer flange having an outer edge including an edge portion adapted to be positioned adjacent to the patient's nostrils; and a sampling tube for collecting air exhaled by the patient through the nose and / or mouth, said sampling tube being connectable to a capnograph so as to enable uninterrupted and unobstructed sampling of CO2 exhaled by the patient and optionally enabling the administration of O2 to said patient while allowing unobstructed surgical or instrumental use of the patient's oral cavity and associated regions.

[0009] This task is also solved by an oral and nasal capnography system adapted to facilitate patient monitoring, the system comprising an oral retention device according to any one of the above claims and further comprising a capnograph adapted to analyze the patient's CO2 level.

[0010] Another improvement of the sampling tube includes a nasal cannula that can be arranged in the patient's nostril or can be arranged adjacent to the patient's nostril. The nasal cannula can be incorporated into the edge portion of the outer flange. In this way, a solution for analyzing the exhaled air has been found.

[0011] The sampling tube can include a mouth exhaust manifold, which is preferably incorporated into the edge of the oral retention device. The mouth exhaust manifold includes holes, slots and / or channels spaced circumferentially along the inner flange, and the holes, slots and / or channels are preferably adapted to be arranged adjacent to the oral mucosa / buccal mucosa along the patient's oral cavity / buccal cavity when the device is installed.

[0012] As an alternative or supplement to the nasal cannula, the sampling tube can include a mouth exhaust manifold for analyzing the exhaled air.

[0013] In another improvement, the oral retention device can include an additional tube for an O2 nasal and mouth supply device.

[0014] In another improvement, the oral retention device can include an external connector for connecting the additional tube to the O2 supply device and a connector for connecting the sampling tube to the capnograph. The advantage of this solution is a simple method for guiding the exhaled air to the capnograph.

[0015] The flange can be biased to expand to help retract the patient's lips and / or cheeks.

[0016] The outer flange can be contoured to fit into the entire outer periphery of the lips and oral cavity.

[0017] The edge of the inner flange and / or the edge of the outer flange is made of a rigid, reinforced but flexible and bendable plastic type tube, connected by an elastic non-reinforced material.

[0018] Another improvement of the oral retention device includes a Y-shaped connector adapted to join at least two branches of the sampling tube into one tube for connection to the capnograph. Thus, the exhaled air from the patient can be easily analyzed.

[0019] The inner flange can be internally contoured to fit into the entire inner periphery of the oral cavity and mucosa.

[0020] Another improvement of the oral and nasal capnography system can include an oxygen supply and monitoring system for administering oxygen to the patient.

[0021] Another improvement solution for the oral and nasal capnography system includes the "OPTRAGATE" TM type device and the capnography sampling pipeline / device, such as including "MICRO STREAM (microflow)" TM or similar devices.

[0022] The object of the present invention is to provide a device that enables uninterrupted and unobstructed sampling of CO2 exhaled by a patient and administration of O2 to the patient, while allowing unobstructed surgery or instrument use in the oral cavity and related areas of the patient. Brief Description of the Drawings

[0023] The integrated drawings represent different embodiments of the subject matter of the present invention by way of example.

[0024] Figure 1 is a schematic front view of the device worn by the patient of the present invention.

[0025] Figure 2 is a schematic diagram of the device of the present invention.

[0026] Figure 3A is taken along line A-A Figure 2 of the cross-section of the device.

[0027] Figure 3B is taken along line B-B Figure 2 of the cross-section of the device.

[0028] Figure 3C is taken along line C-C Figure 2 of the cross-section of the device.

[0029] Figure 4 is another schematic rear view of the device of the present invention.

[0030] Figure 5 is a cross-sectional view of the collection ring of the present invention.

[0031] Figure 6A is an alternative schematic front view of the device of the present invention connected to the oxygen and CO2 monitoring devices.

[0032] Figure 6B is an alternative schematic rear view of the device of the present invention connected to the oxygen and CO2 monitoring devices.

[0033] Those skilled in the art will understand that the elements in the drawings are illustrated for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions may be enlarged relative to other elements to assist in improving the understanding of the present invention and its embodiments. Further, when terms such as "first", "second", etc. are used herein, the use of such terms is intended to distinguish between similar elements and not necessarily to describe a sequential or chronological order. Additionally, relative terms in the specification and / or claims such as "front", "rear", "top", and "bottom" etc. do not necessarily describe exclusive relative positions. Thus, those skilled in the art will understand that such terms may be interchanged with other terms and that the embodiments described herein can be operated in other orientations than those explicitly illustrated or otherwise described. Detailed Description

[0034] The following description is exemplary in nature and is not intended to limit the scope of the present invention in any way, and is thus used to describe the best mode of the present invention known to the inventors as of the filing date of the present application. Accordingly, changes can be made in the arrangement and / or function of any of the elements described in the exemplary embodiments disclosed herein without departing from the spirit and scope of the present invention.

[0035] Now referring to Figure 1 , the perioral holding device 10 is adapted to hold the oral cavity 12 of the patient 1 open against the lips 13 so as to retract the cheeks 2 and thus allow the patient to breathe through the oral cavity and / or through one or both nostrils 14 of the patient.

[0036] Now referring to Figure 2 、 Figures 3A to 3C and Figure 4 ,also referring to Figure 6A and Figure 6B , the holding device 10 includes a semi-rigid, flexible or expandable inner flange 16 and an outer flange 20 connected by a diaphragm 15, the outer flange 20 having an outer edge 22 which includes a perforated edge portion 22" adapted to be positioned adjacent the nostrils 14 of the patient 1 and connected via a tube 56 to an oxygen source 70 for the administration of oxygen. The sampling tube 26 includes a nasal cannula 30 oriented in or below the nostrils of the patient 1 and is connected via tubes 24 and 26 to a CO2 or capnograph 54, such as the sampling tube 32 is preferably incorporated in or connected to the edge 34 of the flange 16 of the holding device 10, the sampling tube 32 serving as a manifold 36 (the manifold 36 may be a second tube adjacent to the inner flange 16 itself, the tube for making the manifold 36 having perforations or slots to enable CO2 sensing), in the manifold 36, holes 40, slots 42 or channels 44 (see Figure 5)Spaced along the circumference 50 of the inner flange 16. Optionally, each of the flanges 16, 20 can be made expandable using two flexible tubes, one of the two flexible tubes sized to pass through the inside of the other flexible tube and fixed at one end with a short overlapping area - glued together, where at the free end, the other smaller diameter end passes into the larger diameter end, and is advantageously biased to expand by inserting a long tension spring into the larger diameter tube to act against the end of the smaller diameter tube or by inserting a thin spring or a flexible rod. Optionally, the sampling nasal cannula 26 and the internal sampling tube 32 incorporated into the inner flange 16 can be connected to a capnograph 54 (using a Y-shaped connector 52 and a connecting tube 74) so that it is possible to sample the CO2 exhaled by the patient continuously and unobstructed, and optionally to administer O2 to the patient through an oxygen tube 56 while allowing surgery or the use of instruments in the patient's oral cavity and associated areas to proceed unobstructed.

[0037] The device 10 of the present invention can also incorporate a capnography sampler into a perioral device via a CO2 monitoring device 54, and this perioral device serves as a lip and cheek retractor device (similar to the "OPTRAGATE" of Ivoclar Vivadent AG TM device, a latex-free lip and cheek retractor that is flexible and elastic for comfortable wearing and helps the patient keep their mouth open), and this lip and cheek retractor device is highly flexible and elastic in all directions of movement to make the patient comfortable and help keep the patient's mouth open while sampling the air inhaled / inhaled and exhaled / exhaled by the patient without obstructing the surgical procedure. The monitoring of CO2 or the detection of carbon dioxide is performed by using a standard capnography sampling pipeline in combination (such as the "MICRO STREAM" of Medtronic TM device).

[0038] The device 10 of the present invention optionally includes:

[0039] - A perioral device (items 15, 16, 20), and the perioral device (items 15, 16, 20) has a width that spans the inner and outer aspects of the oral cavity via expandable or flexible flanges 16, 20;

[0040] - The upper top edge 22 of the flange 20, and the upper top edge 22 is contoured externally according to the entire outer perimeter of the lip 13 and the mouth 12;

[0041] - A lower bottom (inner) flange 16, and the lower bottom (inner) flange 16 is contoured internally according to the entire inner perimeter of the oral cavity and the mucosa;

[0042] - Two flanges 16, 20, made of a rigid, reinforced but flexible and bendable plastic type tube, connected by an elastic non-reinforced material having a low hardness in the range of 30A to 50A; such as present in the off-the-shelf "OPTRAGATE" TM device;

[0043] - A CO2 capnograph, which is carried out via a CO2 monitoring device, which is connected to the inner flange 16 and / or the nasal cannula 30 via a sampling tube 24 incorporated into the edge of the perioral device.

[0044] ○ Upper top edge: The upper sampler is directed into or below the nostrils via the nasal cannula (the same / similar as a common nasal cannula)

[0045] ○ Lower bottom edge: The lower sampler spaces the entire circumference of the oral edge at regular intervals via holes (or slots).

[0046] - An O2 nasal and oral supply device, which is via a specific oriented hole

[0047] - An additional tube for connecting the lower tube to a Y-shaped connector

[0048] - A Y-shaped connector that connects the upper tube and the lower tube into one tube for connection to the capnograph.

[0049] - An external connector leading to the O2 supply device and the capnograph

[0050] The device according to the invention can be manufactured by combining a modified "OPTRAGATE" TM type device or a similar device, and combining it with a "MICRO STREAM (microflow)" TM device or a similar capnograph sampling pipeline / device. An additional tube is added to ensure the monitoring of CO2 from inside the mouth.

[0051] The present invention can be generally summarized as including at least one or a part of one of the following feature sets:

[0052] 1. A perioral holding device (10), the perioral holding device (10) being adapted to keep the patient's oral cavity (12) open to allow the patient to breathe through the oral cavity and / or through one or both nostrils (14) of the patient, while allowing unobstructed surgery or instrument use in the patient's oral cavity and related areas, the holding device comprising:

[0053] ○ An expandable inner flange (16) and an expandable outer flange (20), the outer flange (20) having an outer edge (22), the outer edge (22) including an edge portion (22”) adapted to be disposed adjacent the patient's nostrils (14), and

[0054] ○ Sampling tubes (24, 26, 32) for collecting air exhaled by the patient's nose and / or mouth, the sampling tubes (24, 32) being connectable to a capnograph (54) to enable uninterrupted and unobstructed sampling of CO2 exhaled by the patient.

[0055] 2. The perioral holding device (10) according to Feature Set 1, wherein the sampling tube (26) includes a nasal cannula (30) that can be disposed in the patient's nostrils or can be disposed adjacent the patient's nostrils.

[0056] 3. The perioral holding device (10) according to Feature Set 2, wherein the nasal cannula (30) is incorporated into the edge portion (22”) of the outer flange (20).

[0057] 4. The perioral holding device (10) according to one of the foregoing feature sets, wherein the sampling tube includes a mouth exhaust manifold (36), the mouth exhaust manifold (36) being preferably incorporated into the edge (34) of the perioral holding device (10), the mouth exhaust manifold (36) including holes (40), slots (42) and / or channels (44) spaced along the circumference (50) of the inner flange (16).

[0058] 5. The perioral holding device (10) according to one of the foregoing feature sets, including an additional tube (56) for an O2 nasal and mouth supply device.

[0059] 6. The perioral holding device (10) according to the previous feature set, including an external connector (72) for connecting the additional tube (56) to an O2 supply device and a connector (74) for connecting the sampling tubes (24, 26) to the capnograph (54).

[0060] 7. The perioral holding device (10) according to one of the foregoing feature sets, wherein the flanges (16, 20) are biased to expand to help retract the patient's lips and / or cheeks.

[0061] 8. The perioral holding device (10) according to one of the foregoing feature sets, wherein the outer flange (20) is contoured to fit within the entire outer perimeter of the lips and the oral cavity (12).

[0062] 9. The perioral holding device (10) according to one of the preceding feature sets, wherein the edge of the inner flange (16) and / or the edge of the outer flange (20) is made of a rigid, reinforced but flexible and bendable plastic type tube (60) and is connected by an elastic non-reinforced material.

[0063] 10. The perioral holding device (10) according to one of the preceding feature sets, comprising a Y-shaped connector (52) adapted to join at least two branches of the sampling tubes (24, 26, 32, 66) into one tube for connection to the capnograph (54).

[0064] 11. The perioral holding device (10) according to one of the preceding feature sets, wherein the inner flange (16) is internally contoured to fit within the entire inner circumference of the oral cavity (12) and the mucosa.

[0065] 12. An oral and nasal capnography system (100) adapted to facilitate patient monitoring, the system comprising a perioral holding device (10) according to any one of the above feature sets and further comprising a capnograph (54) adapted to analyze the CO2 level of the patient.

[0066] 13. The oral and nasal capnography system (100) according to the previous feature set, comprising an oxygen supply and monitoring system (70) for administering oxygen to the patient.

[0067] 14. The perioral holding device (10) according to Feature Set 1, wherein the sampling tube (26) is at least partially incorporated into the outer flange (20).

[0068] 15. The oral and nasal capnography system (100) according to one of Feature Sets 12 to 13, comprising a capnography sampling line / device (54), preferably comprising "MICRO STREAM (microflow)" TM or a similar device.

[0069] Among the advantages, there is provided a device 10 that allows reliable exhaled CO2 monitoring of a patient during a procedure involving or requiring or accessing the oral cavity while the patient is in a sedated or anesthetized state.

[0070] In another advantage, there is provided a device that enables sampling of CO2 exhaled by the patient and administration of O2 to the patient while allowing unobstructed surgery or instrumentation of the patient's oral cavity and associated areas.

[0071] It should be understood that the implementations shown and described herein represent the invention and its best mode and are not intended to limit the scope of the invention in any way.

[0072] As will be understood by those skilled in the art, the invention may be embodied as a system, apparatus, or method.

[0073] In addition, systems that use, sell, and / or distribute any goods, services, or information are envisioned to have similar functionality as described herein.

[0074] The specification and drawings should be considered in an illustrative rather than a restrictive sense, and all modifications described herein are intended to be included within the scope of the claimed invention. Thus, the scope of the invention should be determined by the appended claims (as the claims currently exist or as they may later be amended or added, and legal equivalents of the claims) rather than solely by the examples described above. Unless otherwise expressly stated, the steps recited in any method or process claim may be executed in any order and are not limited to the specific order presented in any claim. Additionally, the elements and / or components recited in a device claim may be assembled in various arrangements or otherwise functionally constructed to produce substantially the same result as the invention. Accordingly, the invention should not be construed as limited to the specific configurations recited in the claims.

[0075] The benefits, other advantages, and solutions mentioned herein should not be construed as critical, required, or essential features or components of any or all of the claims.

[0076] As used herein, the term "comprising," "including," or variations thereof means a non-exclusive listing of elements such that any device, process, method, article, or composition of the invention that includes a listing of elements includes not only those recited elements but also other elements such as those described in this specification. Unless otherwise expressly stated, the use of the term "consisting of" or "consisting essentially of" is not intended to limit the scope of the invention to the enumerated elements named thereafter, unless otherwise indicated. Without departing from the general principles of the invention, other combinations and / or modifications of the above elements, materials, or structures used in the practice of the invention may be varied or adapted by those skilled in the art to other designs.

[0077] Unless otherwise noted, the patents and articles mentioned above are hereby incorporated by reference herein to the extent not inconsistent with the present disclosure.

[0078] Other features and modes of implementing the invention are described in the appended claims.

[0079] In addition, the present invention should be considered to include all possible combinations of each feature described in this specification, the appended claims and / or the accompanying drawings, which features may be considered new, inventive and industrially applicable.

[0080] Additional features and functions of the present invention are described in the appended claims and / or abstract herein. Such claims and / or abstract are hereby incorporated by reference in their entirety into this specification and should be considered as part of the application filed.

[0081] In the embodiments of the present invention described herein, various variations and modifications are possible. Although certain illustrative embodiments of the present invention have been shown and described herein, a wider range of changes, modifications and substitutions are contemplated in the foregoing disclosure. While the above description includes many specific details, these details should not be construed as limiting the scope of the present invention, but rather as illustrative of one or another preferred embodiment of the present invention. In some cases, some features of the present invention may be employed without correspondingly using other features. Accordingly, it is appropriate that the foregoing description be construed and understood broadly as merely illustrative, and the spirit and scope of the present invention are limited only by the claims finally issued in this application.

[0082] Appendix

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Claims

1. A perioral retention device (10) adapted to keep a patient's oral cavity (12) open to allow the patient to breathe through the oral cavity and / or through one or both of the patient's nostrils (14), while allowing unobstructed surgery or instrument use in the patient's oral cavity and associated areas, the retention device comprising: ○ An expandable inner flange (16) and an expandable outer flange (20), the outer flange (20) having an outer edge (22) that includes an edge portion (22”) adapted to be positioned adjacent the patient's nostrils (14), and ○ Sampling tubes (24, 26) for collecting air exhaled by the patient's nose and / or mouth, the sampling tube (26) being connectable to a capnograph (54) to enable uninterrupted and unobstructed sampling of CO2 exhaled by the patient.

2. The perioral retention device (10) according to claim 1, wherein, The sampling tube (26) includes a nasal cannula (30) that can be disposed in the patient's nostrils or can be disposed adjacent the patient's nostrils.

3. The perioral retention device (10) according to claim 2, wherein, The nasal cannula (30) is incorporated into the edge portion (22”) of the outer flange (20).

4. The perioral retention device (10) according to one of the preceding claims, wherein, The sampling tube includes a mouth exhaust manifold (36) preferably incorporated in the edge (34) of the perioral retention device (10), the mouth exhaust manifold (36) including holes (40), slots (42) and / or channels (44) spaced along the circumference (50) of the inner flange (16).

5. The perioral retention device (10) according to one of the preceding claims, including an additional tube (56) for an O2 nasal and mouth supply device.

6. The perioral retention device (10) according to the previous claim, including an external connector (72) for connecting the additional tube (56) to an O2 supply device and a connector (74) for connecting the sampling tubes (24, 26) to the capnograph (54).

7. The perioral retention device (10) according to one of the preceding claims, wherein, The flanges (16, 20) are biased to expand to help retract the patient's lips and / or cheeks.

8. The perioral retention device (10) according to one of the preceding claims, wherein, The outer flange (20) is contoured to fit within the entire outer perimeter of the lips and the oral cavity (12).

9. The perioral retention device (10) according to one of the preceding claims, wherein, The edge of the inner flange (16) and / or the edge of the outer flange (20) is made of a rigid, reinforced but flexible and bendable plastic-type tube (60), connected by an elastic non-reinforcing material.

10. The perioral retention device (10) according to one of the preceding claims, including a Y-shaped connector (52) adapted to join at least two branches of the sampling tubes (24, 26, 32, 66) into one tube for connection to the capnograph (54).

11. The perioral retention device (10) according to one of the preceding claims, wherein, The inner flange (16) is internally contoured to fit within the entire inner perimeter of the oral cavity (12) and the mucosa.

12. An oral and nasal capnography system (100) adapted to facilitate patient monitoring, the system comprising an oral perimeter holding device (10) according to any one of the preceding claims, and further comprising a capnograph (54) adapted to analyze the CO2 level of the patient.

13. The oral and nasal capnography system (100) according to the preceding claim, comprising an oxygen supply and monitoring system (70) for administering oxygen to the patient.

14. The perioral retention device (10) according to claim 1, wherein, The sampling tube (26) is at least partially incorporated in the outer flange (20).

15. The oral and nasal capnography system (100) according to one of claims 12 to 13, comprising a capnography sampling line / device (54), preferably comprising "MICRO STREAM (microflow)" TM or a similar device.

16. A system and / or method as described in this specification, the feature set, the appended claims, the abstract (incorporated herein by reference) and / or the accompanying drawings.

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