Supra glottic device

Abstract

The present invention discloses a supra glottic device (SGD), comprising: an airway tube (1) extending to a bowl-shaped cuff (2) located at the distal end of said airway tube, said cuff aperture is in a shape of a sealing ring (3), for sealing between the larynx and the pharynx's wall, wherein, said dorsal side of said cuff, being on the opposite side to said cuff aperture, comprises at least one open groove (4), on either the left or the right side of said cuff dorsal side, for insertion of a gastrointestinal device through either said open groove. Further provided are methods and kits for using the same.

Description

SUPRA GLOTTIC DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application takes priority from provisional application for patent Ser. No. 63 / 530,515 filed on Aug. 3, 2023 entitled “SUPRA GLOTTIC DEVICE" and is incorporated as if fully set forth herein.FIELD OF THE INVENTION

[0002] The present invention is in the field of supra glottic devices (SGDs).BACKGROUND OF THE INVENTION

[0003] Supra glottic devices (SGDs) are medical devices used to maintain an open airway during general anesthesia. They are designed to provide gas exchange between the lungs and the anesthesia machine tract during elective surgeries, while preventing in the majority of cases the entry of air into the esophagus.

[0004] A typical SGD is of the laryngeal mask airway (LMA) type and is known to have an inflatable cuff part, which is positioned at the distal end of an airway tube and its opening faces the laryngeal inlet. Thus, the air can pass through the SGD and enter the patient's larynx. Once correctly positioned, the inflatable cuff is inflated in order to create a seal around the laryngeal opening, ensuring a reliable fit and preventing air leakage.

[0005] Other types of masks are commonly known as cuff less or cuff-free SGDs. Instead of relying on an inflatable cuff to create a seal around the laryngeal opening, the cuff-less SGDs use anatomical design and patient anatomy to achieve a secure fit.

[0006] Cuff- less SGDs typically have a soft, flexible mask portion that is anatomically shaped to conform the contours of the larynx and surrounding structures. This design allows the mask to create a seal without the need for cuff inflation. The soft material of the mask provides a comfortable fit and reduces the risk of pressure-related injuries.

[0007] In some models, the SGDs have an additional channel, allowing access to the esophagus. These gastrointestinal (GI) airway devices function as a regular SGD securing and maintaining a patient airway while allowing the insertion down the esophagus of different endoscopic devices. Some of the common cases include endoscopic procedures such as trans esophageal endoscopy in cardiology (transesophageal echocardiography, TEE), gastro-endoscopy, or other diagnostic and therapeutic procedures requiring a patent-controlled airway while inserting instruments down the digestive tract.

[0008] US20160101254A1 discloses an SGD with an inflatable cuff, specialized for both ventilation and insertion of gastro-endoscopic tube. The channel configured for gastric tube insertion is a closed channel with a fixed size, which makes it difficult for insertion of different sizes of gastric tubes, or a gastric tube with a camera. Moreover, the gastric tube has to be taken out together with the device when the device is pulled out.

[0009] US20180177964A1 discloses a non-inflatable SGD, that features a C-channel, for gastric tube insertion, on the one side of the main airway that goes along the SGD, from the proximal end down to the back of cuff holder. Similarly, since the channel opening is narrow and is along the entire length of the device, there is difficulty in removing the device without removing the gastric tube or inserting different sizes of gastric tubes.

[0010] There is an unmet need for new SGD devices that allow the simultaneously insertion of a gastrointestinal device, such as: a gastric tube, a gastrointestinal endoscope, and a TEE probe, while maintaining the ability to provide patient ventilation or allow normal breathing.SUMMARY OF THE INVENTION[Oi l] According to a first aspect, there is provided a supra glottic device (SGD), comprising: an airway tube (1) extending to a bowl-shaped cuff (2) located at the distal end of the airway tube, the cuff aperture is in a shape of a sealing ring (3), for sealing between the larynx and the pharynx's wall, wherein, the dorsal side of the cuff, being on the opposite side to the cuff aperture, comprises at least one open groove (4), on either the left or the right side of the cuff dorsal side, for insertion of a gastrointestinal device through either open groove.

[0012] In some embodiments, at least one open groove is two open grooves (4), with one groove situated on the left side and another groove located on the right side of the cuff dorsal side.

[0013] In some embodiments, the cuff is a pre-shaped non-inflatable cuff.

[0014] In some embodiments, the gastrointestinal device is selected from the group consisting of: a gastric tube, a gastrointestinal endoscope, a TEE probe, and any combination thereof.

[0015] In some embodiments, the gastric tube is a feeding tube or a drainage tube, and the gastrointestinal endoscope is a gastroscope or a duodenoscope.

[0016] In some embodiments, the SGD is a pediatric SGD or an adult SGD.

[0017] In some embodiments, the SGD is a pediatric SGD comprising a groove diameter in the range of 4 mm to 6 mm.

[0018] In some embodiments, the SGD is an adult SGD comprising a groove diameter in the range of 8 mm to 10 mm.

[0019] In some embodiments, the SGD comprises at least one medical -grade material selected from the group consisting of: silicone, thermoplastic elastomer (TPES), polyvinyl chloride (PVC), and any combination thereof.

[0020] According to another aspect, there is provided a method for airway management and subsequent insertion of gastrointestinal device for diagnostic or therapeutic purposes in a subject in need thereof, the method comprising steps of: a. inserting the SGD disclosed herein into the subject's mouth and advancing it to its final position within the subject's airway; b. introducing the gastrointestinal device through the mouth, via the open groove (4) down the esophagus, thereby, facilitating effective airway management and enabling the insertion and utilization of a gastrointestinal device for diagnostic or therapeutic purposes in the subject.

[0021] In some embodiments, the method further comprising a step of administering appropriate anesthesia to the subject, before step (a).

[0022] In some embodiments, the method further comprising the step of: verifying proper placement of the SGD to maintain airway patency, after step (a) and before step (b).

[0023] In some embodiments, the method further comprising, after step (b) the steps of: c. guiding the gastrointestinal device into the desired position under direct vision; and; d. performing the required procedure or intervention utilizing the gastrointestinal device.

[0024] According to another aspect, there is provided a kit comprising: (a) the SGD disclosed herein; and, (b) instructions for use of the SGD disclosed herein and a gastrointestinal device, setting forth the method disclosed herein.

[0025] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, includingdefinitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0026] Further embodiments and the full scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The presently disclosed subject matter may be more clearly understood upon reading of the following detailed description embodiments of non-limiting exemplary embodiments thereof, with reference to the drawings.

[0028] The following detailed description of embodiments of the presently disclosed subject matter refers to accompanying drawings. Dimensions of components and features shown in figures are chosen for convenience or clarity of presentations and are not necessarily shown to scale. Wherever possible, the same reference numbers will be used throughout the drawings and the following description to refer to the same and like parts.

[0029] Fig. 1 illustrates a supra glottic device (SGD), which comprises an airway tube (1) and a cuff portion (2), where the cuff aperture is in a shape of a sealing ring (3). The dorsal side of the cuff portion features two symmetrically positioned open grooves (4), located on both the right and left sides. These grooves serve as pathways, allowing the passage of a gastro-intestinal tube on either side.

[0030] Fig. 2 is a schematic illustration of an SGD placed in a patients' airway, demonstrating the airway tube (1), the cuff portion (2), and the sealing ring (3), for sealing between the patient larynx and the pharynx's wall. The groove (4) allows the passage of a gastro-intestinal tube via the esophagus.

[0031] Fig. 3 is a drawing of the dorsal side of the SGD, illustrating the airway tube (1), the cuff portion (2), and the dorsal open grooves (4).

[0032] Fig. 4 is a drawing of the ventral side of the SGD, illustrating the airway tube (1), the cuff portion (2), and the cuff aperture (3).

[0033] Fig. 5 is a drawing of the distal side of the SGD, illustrating the airway tube (1), the cuff portion (2), and the cuff aperture (3) and the open grooves (4).DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] According to a first aspect, there is provided a supra glottic device (SGD), comprising: an airway tube (1) that extends to a cuff (2) of a bowl shape at the distal end of the airway tube, the cuff aperture is in a shape of a sealing ring (3), ensuring a fit between the larynx and the pharynx's wall, wherein, the dorsal side of the cuff, being on the opposite side to the cuff aperture, comprises at least one open groove (4), on either the left or the right side of the cuff dorsal side, allowing the insertion of a gastrointestinal device through either open groove.

[0035] In some embodiments, the SGD disclosed herein comprises two open grooves (4), with one groove situated on the left side and another groove located on the right side of the cuff dorsal side.

[0036] As used herein; the term "cuff" refers to a mask portion, designed to cover the laryngeal opening and establish a seal around it; the term "airway tube" encompasses a long, flexible tube attached to the mask portion, inserted into the patient's mouth and extends into the throat, providing a pathway for ventilation; the term "sealing ring" refers to an integral part of the cuff design and aids in creating a reliable seal around the larynx, to prevent air leakage during positive pressure ventilation.

[0037] The cuff portion of the SGD may be inflatable or non-inflatable.

[0038] The term "inflatable cuff refers to a cuff comprising a mechanism that allows inflation with air or a liquid to create a seal against the walls of the larynx and surrounding structures.

[0039] In some embodiments, the SGD disclosed herein comprises a non-inflatable cuff.

[0040] As used herein, the term "non-inflatable cuff refers to a pre-formed shape that is designed to fit the anatomy of the larynx and provides a seal without the need for inflation. In some embodiments, the cuff is made of a soft, flexible material that conforms to the larynx and surrounding structures. In some embodiments, the sealing ring disclosed herein is designed to have a proper fit against the larynx and pharynx walls without the need for cuff inflation.

[0041] In some embodiments, the SGD described herein allows for the concurrent insertion of a gastrointestinal device via the left groove or the right groove, down the esophagus. In some embodiments, insertion of the gastrointestinal device through the groove to the subject's esophagus is while the SGD remains in place within the subject's airway. Furthermore, incertain embodiments, the SGD facilitates its removal from the subject's airway without requiring removal of the gastrointestinal device.

[0042] In some embodiments, the presence of a groove solely on the dorsal side of the cuff in the SGD disclosed herein, allows for the insertion of a gastrointestinal device with a larger diameter, as compared to an SGD comprising a groove extending from the proximal end down to the cuff. The design of a groove solely on the dorsal side of the cuff enhances the device's versatility, facilitating the use of a gastrointestinal endoscope or a TEE probe that may have a larger size compared to standard gastric tube. The dorsal groove provides the necessary space and flexibility for accommodating various medical instruments, ensuring effective and safe procedures.

[0043] In some embodiments, the presence of two symmetric grooves, one on each side of the cuff, offers two main advantages over having just one groove on either the left side or the right side:(a) If difficulties arise during insertion of the gastrointestinal device through one groove (e.g., due to resistance force or specific anatomical structures of the pharynx), the user has the option to reattempt insertion from the opposite side groove, providing greater flexibility and adaptability.(b) Inserting the gastrointestinal device via one groove leads to an inward folding of the opposite side groove. This inward folding helps prevent excessive pressure on the mucosa, reducing the risk of injuries and / or the risk of displacing the SGD from its intended position.

[0044] As used herein, the term "gastrointestinal device" refers to a medical device inserted through the nose or mouth, to the gastrointestinal (GI) system, and configured for gastrointestinal and / or cardiac evaluation and / or therapy.

[0045] In some embodiments, the gastrointestinal device is selected from: a gastric tube, a gastrointestinal endoscope, and a TEE probe.

[0046] In some embodiments, the gastric tube is selected from: a feeding tube, configured to deliver nutrition, fluids, or medications directly into the gastrointestinal tract, and a drainage tube for removing excess fluids, gas, or stomach contents. In some embodiments, a gastrointestinal endoscope is selected from: a gastroscope and a duodenoscope.

[0047] The term " gastrointestinal endoscope" used herein refers to a flexible tube with a washing channel, a suction channel and a light source and camera attached to one end, used to visualize the inside of the upper gastrointestinal tract, including the duodenum. The herein used term"gastric tube", encompasses a device inserted through the nose or mouth into the stomach, used for feeding, drainage, or administering medication. The term "TEE probe" used herein refers to a specialized ultrasound probe designed for transesophageal echocardiography (TEE), inserted into the esophagus to obtain detailed images of the heart's structures and assess cardiac function.

[0048] In some embodiments, the gastric tube is selected from: (a) nasogastric tube, inserted through the nose and extends into the stomach, commonly used for short-term feeding, decompression, or medication administration, (b) orogastric tube, inserted orally through the mouth and down the throat into the stomach, and (c) nasoenteric tube, inserted through the nose and extends beyond the stomach reaching the small intestine (e.g., duodenum or jejunum).

[0049] The combination of an SGD and a gastric tube is often required in various medical procedures where airway management and gastric decompression or drainage, are required simultaneously. Non-limiting examples for such medical procedures include: (a) general anesthesia, in which an SGD can be used to maintain a patient airway and assist with ventilation or breathing. A gastric tube may be inserted alongside the SGD to decompress the stomach and prevent gastric distention; (b) laparoscopic procedure, where the abdomen is inflated with carbon dioxide, a gastric tube may be inserted through the SGD to continuously decompress the stomach; and, (c) rare life / death situations where conventional endotracheal intubation proves unsuccessful, and further attempts could jeopardize an already compromised airway.

[0050] The simultaneous use of an SGD and a gastrointestinal endoscope is necessary in specific medical situations. One common scenario is during endoscopic procedures that require both airway management and access to the gastrointestinal tract. Additional medical non-limiting situations where the concurrent use of a gastroscope and an SGD for airway management may be beneficial are: (a) Endoscopic Retrograde Cholecysto Pancreatography (ERCP), a procedure used to diagnose and treat conditions affecting the bile and pancreatic ducts; and, (b) Endoscopic Resection of Lesions, such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), may require prolonged periods of time, during which maintaining a patient airway using an SGD can be beneficial.

[0051] Typically, gastric tubes come in different sizes, identified by their French (Fr) size. One French (Fr) unit is equal to 0.33 millimeters.

[0052] In some embodiments, the disclosed SGD is an adult SGD, e.g., in a size appropriate for an adult. In some embodiments, the disclosed groove is in a size corresponding to an adult gastrictube, an adult gastroscope, and both. In some embodiments, the disclosed SGD is a pediatric SGD, e.g., in a size appropriate for a child. In some embodiments, the disclosed groove is in a size corresponding to a pediatric gastric tube, a pediatric gastroscope, and both. In some embodiments, the disclosed SGD is an infant SGD, e.g., in a size appropriate for an infant. In some embodiments, the disclosed groove is in a size corresponding to an infant gastric tube, an infant gastroscope, and both.

[0053] In some embodiments, the pediatric SGD comprises a size corresponding to LMA number 2.5 (children 20-30kg). In some embodiments, the pediatric SGD comprises a groove diameter in the range of 4 mm to 6 mm.

[0054] In some embodiments, the adult SGD comprises a size corresponding to LMA number 3 and above. In some embodiments, the adult SGD comprises a groove diameter in the range of 8 mm to 10 mm.

[0055] Typical outer diameter sizes of gastrointestinal endoscopes for adult patients range from 9 mm to 11 mm, for pediatric patients range from 5.5 mm to 8 mm, and for infants range from 2.8 mm to 5 mm.

[0056] Typical outer diameter sizes of gastric tubes (e.g., feeding tubes or draining tubes) for adult patients range from 4 mm to 6 mm (9.8 Fr to 18 Fr), for pediatric patients range from 2.7 mm to 4.7 mm (8 Fr to 14 Fr), and for infants range from 1.7 mm to 2.7 mm (5 Fr to 8 Fr).

[0057] In some embodiments, the SGD is an adult SGD comprising a groove adjusted to a gastric tube diameter in the range of 12 Fr to 36 Fr. In some embodiments, the adult SGD comprises a groove with a diameter in the range of 36 Fr - 40 Fr.

[0058] In some embodiments, the SGD is a pediatric SGD comprising a groove adjusted to a gastric tube diameter in the range of 8 Fr to 24 Fr. In some embodiments, the pediatric SGD comprises a groove with a diameter in the range of 24 Fr - 28 Fr.

[0059] In some embodiments, the SGD is an infant SGD comprising a groove adjusted to a gastric tube diameter in the range of 5 Fr to 12 Fr. In some embodiments, the infant SGD comprises a groove with a diameter in the range of 12 Fr - 16 Fr.

[0060] In some embodiments, the SGD disclosed herein is made from a medical grade flexible material. The airway tube (1), the cuff portion (2), and the sealing ring (3) can be made from the same material, or from different materials. In some embodiments, the airway tube, the cuff portion, and the sealing ring, disclosed herein, are composed of the same flexible material.

[0061] In some embodiments, the SGD disclosed herein is made from a medical-grade material compatible with supraglottic devices. In certain embodiments, the SGD disclosed comprises at least one medical-grade material selected from: silicone, thermoplastic elastomer (TPEs), polyvinyl chloride (PVC), or any combination thereof. These materials provide flexibility and biocompatibility, allowing for effective airway management, concomitantly with adjustment to the patients' larynx.

[0062] In some embodiments, TPEs are selected from: Styrenic Block Copolymers, Thermoplastic Polyurethanes, Thermoplastic Vulcanizates, and Thermoplastic Olefins.

[0063] In some embodiments silicone is selected from: Polydimethylsiloxane (PDMS), Liquid Silicone Rubber (LSR), and High Consistency Rubber (HCR).

[0064] According to another aspect, there is provided a kit comprising: (a) the SGD disclosed herein; and, (b) instructions for use of the SGD disclosed herein, and a gastrointestinal device, setting forth the method disclosed herein.

[0065] As used herein, the term "about" when combined with a value refers to plus and minus 10% of the reference value. For example, a length of about 1000 nanometers (nm) refers to a length of 1000 nm ± 100 nm.

[0066] It is noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0067] In those instances where a convention analogous to "at least one of A, B, and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B" or "A and B."

[0068] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.All combinations of the embodiments pertaining to the invention are specifically embraced by the present invention and are disclosed herein just as if each and every combination was individually and explicitly disclosed. In addition, all sub-combinations of the various embodiments and elements thereof are also specifically embraced by the present invention and are disclosed herein just as if each and every such sub-combination was individually and explicitly disclosed herein.

[0069] Additional objects, advantages, and novel features of the present invention will become apparent to one ordinarily skilled in the art upon examination.

Claims

CLAIMSWhat is claimed is:

1. A supra glottic device (SGD), comprising: an airway tube (1) extending to a bowl-shaped cuff (2) located at the distal end of said airway tube, said cuff aperture is in a shape of a sealing ring (3), for sealing between the larynx and the pharynx's wall, wherein, said dorsal side of said cuff, being on the opposite side to said cuff aperture, comprises at least one open groove (4), on either the left or the right side of said cuff dorsal side, for insertion of a gastrointestinal device through either said open groove.

2. The SGD of claim 1, wherein said at least one open groove is two open grooves (4), with one groove situated on the left side and another groove located on the right side of said cuff dorsal side.

3. The SGD of claim 1 or 2, wherein said cuff is a pre-shaped non -inflatable cuff.

4. The SGD of any one of claims 1 to 3, wherein said gastrointestinal device is selected from the group consisting of: a gastric tube, a gastrointestinal endoscope, a TEE probe, and any combination thereof.

5. The SGD of claim 4, wherein said gastric tube is a feeding tube or a drainage tube, and said gastrointestinal endoscope is a gastroscope or a duodenoscope.

6. The SGD of any one of claims 1 to 5, wherein said SGD is a pediatric SGD or an adult SGD.

7. The SGD of claim 6, wherein said SGD is a pediatric SGD comprising a groove diameter in the range of 4 mm to 6 mm.

8. The SGD of claim 6 or 7, wherein said SGD is an adult SGD comprising a groove diameter in the range of 8 mm to 10 mm.

9. The SGD of any one of claims 1 to 8, comprising at least one medical -grade material selected from the group consisting of: silicone, thermoplastic elastomer (TPES), polyvinyl chloride (PVC), and any combination thereof.

10. A method for airway management and subsequent insertion of gastrointestinal device for diagnostic or therapeutic purposes in a subject in need thereof, the method comprising steps of:a. inserting the SGD of any one of claims 1 to 9 into the subject's mouth and advancing it to its final position within the subject's airway; b. introducing the gastrointestinal device through the mouth, via said open groove (4) down the esophagus, thereby, facilitating effective airway management and enabling the insertion and utilization of a gastrointestinal device for diagnostic or therapeutic purposes in said subject.

11. The method of claim 10, wherein said gastrointestinal device is selected from the group consisting of: a gastric tube, a gastrointestinal endoscope, transesophageal echocardiography (TEE) probe, and any combination thereof.

12. The method of claim 10 or 11, further comprising a step of administering appropriate anesthesia to said subject, before said step (a).

13. The method of any one of claims 10 to 12, further comprising the step of: verifying proper placement of said SGD to maintain airway patency, after said step (a) and before said step (b).

14. The method of any one of claims 10 to 13, further comprising, after said step (b) the steps of: c. guiding said gastrointestinal device into the desired position under direct vision; and, d. performing the required procedure or intervention utilizing said gastrointestinal device.

15. A kit comprising : a. the SGD of any one of claims 1 to 9, and; b. instructions for use of said SGD and a gastrointestinal device, setting forth the method of any one of claims 10 to 14.

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