Search

EP-4398966-B1 - A PROCEDURAL SEDATION MOUTHPIECE

EP4398966B1EP 4398966 B1EP4398966 B1EP 4398966B1EP-4398966-B1

Inventors

  • ÅKESON, Jonas
  • LJUNGVALL, Magnus
  • BRAIAN, Michael
  • LIST, THOMAS

Dates

Publication Date
20260513
Application Date
20220909

Claims (14)

  1. A mouthpiece (10) for providing a free upper airway during procedural sedation, the mouthpiece (10) comprising: a body (100) comprising an airway channel (102) extending from a first end (104) of the body (100) to a second end (106) of the body (100), wherein the first end (104) is an anterior end of the body (100) and the second end (106) is a posterior end of the body (100), a first stop (118) supported by the body (100) configured to control the insertion depth of the body (100) into the oral cavity of a patient, a second stop (120a, 120b) supported by the body (100), a thermoplastic element (200) supported by the body (100), the thermoplastic element (200) having a malleable state in which the thermoplastic element (200) is configured to receive a dental impression from the patient and a set state for allowing fixation of the dental impression, wherein the thermoplastic element (200) is arranged between the first stop (118) and the second stop (120a, 120b) such that anterior and posterior movement of the thermoplastic element (200) in relation to the body (100) is restricted by means of the first stop (118) and the second stop (120, 120a, 120b), respectively, wherein the second stop (120a, 120b) comprises a first protrusion (120a) extending from the body (100) and having an anterior sloping surface (122) configured to induce anterior movement of the lower jaw of the patient in response to the thermoplastic element (200) receiving the dental impression.
  2. The mouthpiece (10) according to claim 1, wherein the second stop (120a, 120b) comprises a second protrusion (120b) extending from the body (100) and having an anterior sloping surface (124) configurated for appropriately positioning the teeth of the upper and lower jaws in relation to the body (100) in response to the thermoplastic element (200) receiving the dental impression.
  3. The mouthpiece (10) according to any one of claims 1 or 2, wherein the second stop (120a, 120b) comprises a plurality of flanges extending from the body (100).
  4. The mouthpiece (10) according to any of the preceding claims, wherein the first stop (118) comprises an annular flange (118) associated with the first end (104) of the body (100).
  5. The mouthpiece (10) according to claim 4, further comprising a grip element (110) supported by the annular flange (118) and configurated to facilitate manual handling of the mouthpiece (10).
  6. The mouthpiece (10) according to any one of the preceding claims, wherein the second end (106) of the body (100) is curved.
  7. The mouthpiece according to any one of the preceding claims, wherein the annular flange (118) is curved.
  8. The mouthpiece (10) according to any one of the preceding claims, further comprising at least one tubular connection (108) defining a side channel (114) extending from an access port (116) available from the first end (104) of the body (100) into the airway channel (102).
  9. The mouthpiece (10) according to any one of the preceding claims, wherein the thermoplastic element (200) has a truncated conical shape tapering towards the second end (106) of the body (100).
  10. The mouthpiece (10) according to claim 9 when dependent on claim 6, wherein the thermoplastic element (200) has a posterior end (212) having a curvature corresponding to that of the first end (104) of the body (100).
  11. The mouthpiece (10) according to any one of the preceding claims, wherein the thermoplastic element (200) is made of ethylene-vinyl acetate (EVA) copolymer.
  12. The mouthpiece (10) according to claim 8, wherein the access port (116) of the at least one tubular connection (108) comprises a fitting of a Luer lock type.
  13. The mouthpiece (10) according to any one of the preceding claims, wherein the airway channel (102) has an elliptical cross-sectional area.
  14. The mouthpiece (10) according to any one of the preceding claims, wherein the first stop (118) and the second stop (120a, 120b) are integrally formed with the body (100).

Description

Field of the invention The present invention relates to procedural sedation and more particularly to a mouthpiece for providing a free upper airway during procedural sedation as defined by the appended claims. Background art Procedural sedation is a technique of administering sedative or dissociative anaesthetic drugs with or without analgesic drugs to induce a state that allows the patient to tolerate unpleasant procedures. It usually involves administration of short-acting sedative drugs. The demand for procedural sedation has been shown to be increasing, as more and more patients are being offered sedation to reduce discomfort associated with different kinds of medical procedures. Procedural sedation involves placing the patient in a state of depressed consciousness. In such a state, the patient may be at increased risk of reduced or discontinued respiratory function and cardiac arrhythmias. Reduced respiratory function during procedural sedation may result from inhibitory effects of the sedative drugs on the respiratory centre in the brain stem, from reduced diaphragmatic activity, and from reduced neuromuscular control of the upper airway tension. Reduced muscle tonus within the oral cavity and throat may cause the lower jaw and tongue to fall backwards and obstruct the upper airways. Such an obstruction must be detected immediately and managed rapidly and appropriately at the bedside to ensure that the patient continues to receive oxygen and remove carbon dioxide. To be prepared for instant such action, anaesthesiologists and anaesthesia nurses constantly monitor the patient for any sign of respiratory depression or hypoxia throughout a procedural sedation. However, procedural sedations are not always performed within the controlled environment of a hospital, but more frequently by less experienced healthcare providers outside hospitals. It is thus most desirable to find a better way of maintaining patent upper airways during procedural sedation. US2010262033 describes a bite block comprising an insertion channel and an airway channel. Summary of the invention In view of what is stated above, the main objective of the current invention is to provide a mouthpiece that facilitates maintenance of free upper airways during procedural sedation. To achieve the main objective and also specific objects that will be evident from the following description, a mouthpiece having the features defined in claim 1 is provided according to the present invention. Preferred embodiments of the mouthpiece will be evident from the dependent claims. More specifically, the present invention provides a mouthpiece for maintenance of a free upper airway during procedural sedation. The mouthpiece comprises: a body comprising an airway channel extending from a first end of the body to a second end of the body, where the first end is an anterior end of the body and the second end is a posterior end of the body,a first stop supported by the body, configured to control the insertion depth of the body into the oral cavity of a patient,a second stop supported by the body,a thermoplastic element supported by the body. The thermoplastic element having a malleable state in which the thermoplastic element is configured to receive a dental impression from the patient and a set state for allowing fixation of the dental impression. The thermoplastic element is arranged between the first stop and the second stop such that anterior and posterior movement of the thermoplastic element in relation to the body is restricted by means of the first stop and the second stop, respectively. The position of the jaws of the patient can thus be fixated in the set state of the thermoplastic element, which reduces the risk of the lower jaw and tongue of the patient falling backwards and causing an airway obstruction. This reduces the workload for the caregivers monitoring the patient. The central working and airway channel allows transoral access to the patient for a procedure and enables the patient to breathe unrestricted. The second stop may comprise a first protrusion extending from the body and having an anterior sloping surface configured to induce anterior movement of the lower jaw of the patient in response to the thermoplastic element receiving the dental impression. The first protrusion facilitates positioning of the lower jaw of the patient in relation to the mouthpiece when the patient forms the dental impression. The second stop may comprise a second protrusion extending from the body and having an anterior sloping surface configured for appropriately positioning the teeth of the upper and lower jaws in relation to the body in response to the thermoplastic element receiving the dental impression. The upper jaw being correctly arranged in relation to the body facilitates the relative positioning of the lower jaw, which may be positioned in the thermoplastic element after the teeth of the upper jaw have been positioned. The second stop may comprise