Introducer device

Abstract

The present invention relates to an introducer device (1) for aiding the insertion of an enteral tube (30) into a patient, when an endotracheal tube (33) is already present. The introducer device comprising an elongate body with a functional head portion (10) for insertion into the patient's mouth (50), the head portion being provided with opposing exposed channel (3) and recessed area (11) to enable removal of the introducer device independently of the enteral tube and endotracheal tube.

Description

[0001] INTRODUCER DEVICE

[0002] The present invention relates to an introducer device for guiding the insertion of enteral tubes such as gastroenteric tubes, in particular to an introducer device suitable for guiding the insertion of enteral tubes in anaesthetised patients and removable independently of the enteral tube.

[0003] Background to the Invention

[0004] Among the most performed nonvascular procedures in hospitalised patients is the placement of nasoenteral (NE) tubes. The insertion of NE tubes into the gastrointestinal (Gl) tract of patients, typically anaesthetised patients, who require the placement of such devices for the purposes of delivering nutrition or facilitating drainage from the Gl tract is a commonly performed procedure with a relatively low success rate, specifically the insertion of nasogastric (NG) tubes into the stomach via blind insertion or assisted with a Laryngoscope or Magill forceps.

[0005] Large-bore NE tubes are generally used for both diagnostic and therapeutic purposes, whereas small-bore NE tubes are used primarily for intestinal feeding. In a large proportion of procedures, due to the flexibility and curvature of the NE tube, it becomes coiled in the mouth or pharynx and fails to enter the oesophagus or may inadvertently be inserted into the patient’s respiratory tract, predisposing to injury. This problem is common in both patients who are anaesthetised and those who have alternatively or additionally undergone the insertion of an endotracheal tube to secure their airway and allow mechanical ventilation with a ventilator.

[0006] While various methods and devices have been proposed to enhance enteral tube placement success, many fall short in effectiveness or become cumbersome through their use of repurposed or modified medical equipment. In addition, most introducer devices are suitable for use with NE tubes only and do not accommodate endotracheal tubes. Another deficit with many known available introducer devices is that these do not enable separation of the introducer from the enteral tube after placement, thereby facilitating only temporary placement of the enteral tube. Some introducer devices do enable independent removal of the introducer device; however, these are complex and typically require splitting or cutting the introducer device while it is still inserted in the patient which is awkward and can disturb the placement of the enteral tube or inadvertent removal of the enteral tube. It is therefore an object of the present invention to provide an introducer device to aid the insertion of nasoenteral tubes into the Gl tract of patients which overcomes the drawbacks of known solutions or at least provides a suitable alternative.

[0007] Summary of the Invention

[0008] The present invention addresses the problem of misplacement of enteral tubes in a patient. The present invention also addresses the problem of enabling independent removal of the introducer device from a patient without disturbing or also removing the enteral tube after it has been inserted.

[0009] This problem is solved by providing an introducer device which is capable of engaging with a patient’s tissue to form a channel for an enteral tube.

[0010] The invention is set out in the claims.

[0011] Accordingly, a first aspect of the present invention is an introducer device for aiding the insertion of an enteral tube into a patient and enabling removal of the introducer device independently of the enteral tube and an endotracheal tube present in the mouth, pharynx and trachea of the patient, the introducer device comprising a functional head portion having an exposed guiding channel for guiding the enteral tube into the oesophagus of the patient and an opposing recessed area for accommodating the endotracheal tube. The posterior side of the head portion is provided with the guiding channel and the anterior side with the recessed area for accommodating the endotracheal tube.

[0012] By exposed is meant the guiding channel is not covered. In other words, the guiding channel is open in cross-section and at both ends such that it is in the form of a groove rather than a passageway only accessible from the ends.

[0013] Advantageously, when the introducer device is placed correctly in the pharynx of a patient, the guiding channel is able to catch the tip of an enteral tube in the area of the pharynx and channel the enteral tube in a direction from the pharynx to the upper oesophagus.

[0014] Further advantageously, the introducer device prevents coiling and assists correct placement of an enteral tube such as a nasogastric tube in midline of a patient’s pharynx, permitting removal of the introducer device independently from the enteral tube. Yet further advantageously, the introducer device may be removed without removal of the enteral tube and without requiring further manipulation or tearing of the introducer device. This is in comparison to other introducer devices comprising closed guiding conduits which must be split to enable removal of the introducer device without removing the enteral tube.

[0015] The introducer device has a proximal end and a distal end such that, in use, the distal end is inserted into the pharynx of a patient via the patients mouth.

[0016] Advantageously, the introducer device can be inserted orally.

[0017] The introducer device further has a first side and an opposing second side such that, in use, the first side faces the roof of the mouth and the back of the pharynx of a patient and the second side faces the tongue and larynx. The first side may be referred to interchangeably herein as the posterior side and the second side may be referred to interchangeably herein as the anterior side. Lateral sides extend from the first side to the second side to prove a left-hand side and a right-hand side of the introducer device.

[0018] The introducer device has no role in artificial ventilation of the patient. Instead, in use, the introducer device acts as conduit from the nasopharynx to the opening of the oesophagus eliminating known resistance points and diverting the tube tip into the upper oesophagus of a patient, preventing the tube from being directed forwards and into the patient’s mouth by slightly elevating the lower jaw, tongue and larynx and supporting this unsupported muscular tube which normally exists in collapsed state.

[0019] The introducer device comprises an elongate body with the functional head portion preferably located at one end of the elongate body. The elongate body may be solid, hollow or concave, e.g., U-shaped.

[0020] The elongate body ideally comprises a curvature that conforms to the anatomy of the pharynx area to aid positioning of the introducer device such that, in use, the functional head portion of the introducer device reaches the optimum position within a patient’s pharynx, ideally wherein the distal most point of the introducer device reaches the area of the C5 or C6 intervertebral disc. Thus, in use, the elongate body matches the path from the patient’s palate / tongue backward towards the pharynx and curves to run from the pharynx to the oesophagus. In some embodiments, the functional head portion has an alternating depth along its length such that it is substantially wedge shaped, particularly preferably wherein the depth of the functional head portion increases away from the distal end of the head portion to enable gradual anterior displacement of the larynx as the introducer device progresses down the pharynx.

[0021] Advantageously, the introducer device can wedge the oesophagus open.

[0022] In a particularly preferred embodiment, the depth of the functional head portion increases away from both ends of the functional head portion.

[0023] The skilled person will understand that the distance between the first and second sides, i.e. , the depth of the introducer device, in the area of the guiding channel is minimal to provide space for the enteral tube. The depth of the introducer device at the distal end of the functional head portion is preferably in the range of from about 1.5mm to about 5mm, e.g., about 2mm.

[0024] Additionally, or alternatively, the depth of the functional head portion gradually increases from the distal to proximal end thereof, preferably wherein the depth is in the range of from about 8mm to about 14mm, e.g., about 11mm at the deepest part of the head portion.

[0025] Advantageously, in use, the gradually increasing depth of the functional head portion automatically and gradually pushes a patient’s larynx away from their spine to increase opening of their oesophageal inlet as the introducer device is being inserted.

[0026] In a preferred embodiment, the depth of the functional head portion is deeper at the lateral sides than at the centre of introducer device to provide space for an enteral tube to pass during use of the device.

[0027] The guiding channel is preferably located on a posterior side of the introducer device.

[0028] The guiding channel is preferably open through approximately 180° in cross-section.

[0029] Alternatively, or additionally, the guiding channel is preferably curved to correspond to the cylindrical shape of an enteral tube, for example the guiding channel may be a substantially U-shaped channel. Advantageously, the conformity of the shape of the guiding channel to that of an enteral tube prevents an inserted enteral tube getting stuck between surfaces of the guiding channel or abutting against surfaces of the guiding channel to avoid the enteral tube getting stuck or coiling back on itself as it is being inserted.

[0030] Advantageously, in use, the open guiding channel will not be closed 360° around the enteral tube. Therefore, this enables the introducer device to be removed from the patient independent of the enteral tube. This is in comparison to known introducer devices which only enable enteral tubes to remain inserted while the introducer device is inserted, or which need to be split or cut along their length to enable their removal independent from the enteral tube.

[0031] In some embodiments, the introducer device comprises a protuberance on either side of the guiding channel on the functional head portion for engaging with the patient’s tissue to form a closed channel between the introducer device and the patient’s tissue. Advantageously, this prevents lateral movement of the enteral tube beyond the width of the guiding channel.

[0032] Each protuberance independently is preferably convex.

[0033] In a preferred embodiment, the guiding channel is tapered. In this embodiment, the opening at the proximal end of the guiding channel is wider than the opening at the distal end such that, when the introducer device is placed correctly in the pharynx of a patient, the guiding channel funnels an inserted enteral tube between the patient’s tissue and the guiding channel.

[0034] In a preferred embodiment, the introducer device is shaped to engage with the pharynx to seat the introducer device correctly in the pharynx.

[0035] Preferably, the introducer device or a portion of the introducer device is shaped for filing the space of the pyriform sini to prevent the enteral tube from entering this area.

[0036] Ideally, the protuberances of the introducer device each comprise an extension portion for blocking the pyriform sini, preferably wherein the extension portions extend laterally away from the guiding channel. Advantageously, this prevents the enteral tube from entering the space of the pyriform sini should it slip out of the guiding channel.

[0037] The extension portions preferably form the lateral sides of the functional head portion.

[0038] In a preferred embodiment, the extension portions are shaped to conform with the shape of the pharynx. Advantageously, this ensures optimum engagement with the patient’s tissue such that the enteral tube is pressed against the back wall of the pharynx should it slip out of the guiding channel.

[0039] Further advantageously, the extension portions shaped to conform with the shape of the pharynx prevent the enteral tube from entering the pyriform sini or from coiling back on itself. Additionally, conformity of the shape of the extension portions to the pharynx prevents the extension portions from causing damage to the patient’s tissue.

[0040] Each extension portion independently is preferably convex.

[0041] In a preferred embodiment, each extension portion independently extends from the first side towards the second side of the introducer device.

[0042] Preferably, the introducer device is shaped to enable anterior displacement of the larynx.

[0043] Advantageously, the introducer device enables opening of the oesophageal inlet behind the larynx and creates a passageway for the enteral tube via the guiding channel.

[0044] In some embodiments, the extension portions each independently have an alternating depth along their length such that they are substantially wedge shaped, particularly preferably wherein the depth of each extension portion independently increases away from the distal end of the head portion to enable gradual anterior displacement of the larynx.

[0045] Alternatively, or additionally, the introducer device can be pulled forward by the user to engage a patient’s larynx and manually move the larynx anteriorly.

[0046] Advantageously, the introducer device can be used to push the larynx and, optionally, the mandible forward together with the tongue. In a preferred embodiment, the width of the functional head portion gradually increases away from one or both ends, ideally from the tip at the distal end to prevent over insertion of the introducer device.

[0047] Advantageously, in use of the introducer device, the increasing width causes the functional head portion to abut against the sides of the patient’s pharynx thereby preventing the introducer device from being progressed too far down the throat or oesophagus of the patient.

[0048] In a preferred embodiment, the width of the functional head portion gradually decreases from a maximum width in the range of from about 20mm to about 50mm, preferably from about 30mm to about 45mm, e.g., 43 mm, towards one or both ends, ideally towards the tip at the distal end, particularly preferably wherein the head portion is about 15 mm wide at the distal end.

[0049] In a preferred embodiment, the functional head portion, most preferably a portion of the anterior side of the head portion, is shaped to extend over the entry point of the patient’s larynx to prevent entry of the enteral tube into the larynx.

[0050] Advantageously, this prevents the enteral tube from being directed into the lower respiratory tract of the patient.

[0051] The functional head portion of the introducer device comprises a recessed area for accommodating an endotracheal tube which may already be present in the mouth, pharynx and trachea of an anaesthetised patient.

[0052] Advantageously, this enables use of the introducer device in patients who are already intubated. Advantageously, the introducer device can be used on patients already intubated with an endotracheal tube. Additionally, the introducer device can correctly position itself using an existing endotracheal tube as a guide or point of centralisation.

[0053] The recessed area is shaped to correspond to the outer curvature of an endotracheal tube. Advantageously, this enables easy placement of the recessed area over an endotracheal tube.

[0054] The guiding channel and the recessed area are located on opposite sides of the introducer device and are ideally open in opposite directions relative to one another, wherein the guiding channel is located on the posterior side and the recessed area on the anterior side. Locating the guiding channel and recessed area on opposite sides of the introducer device improves the ease of insertion and removal of the introducer device without inadvertently affecting one or more of the enteral tube and the endotracheal tube.

[0055] Further advantageously, locating the guiding channel and recessed area on opposite sides of the introducer device enables the recessed area to be easily located over an endotracheal tube whilst allowing the guiding channel to form a clear pathway to the oesophagus.

[0056] The introducer device is recessed on the opposite side to guiding channel to create a recessed area to fit around existing ET tube, wherein the guiding channel is located on a posterior side of the head portion and the recessed area is located on the opposite anterior side of the head portion.

[0057] The recessed area may be an open channel, an indentation or any other concavity suitable to engage with an ET tube.

[0058] Ideally, the recessed area is located between raised portions on the second side of the introducer device, most preferably wherein the raised portions are a continuation of the protuberances adjacent the guiding channel such that the lateral sides of the functional head portion are convex.

[0059] The length of the introducer device is preferably in the range of from approximately 140 mm to approximately 200mm, particularly preferably from about 170mm to about 185mm. However, this is not to be considered limiting and alternative lengths are contemplated in the scope of the inventions, for example shorter lengths for use with child patients.

[0060] The surface of the introducer device is preferably smooth to prevent unnecessary trauma to the patient’s tissues. Ideally, the external surface of the introducer device comprises material with a low friction coefficient such as thermoplastic polyurethane, silicone or soft rubber to facilitate easy insertion and removal of the introducer device and to prevent resistance to the enteral tube throughout insertion. By low friction coefficient is meant a coefficient of friction in the range of from about 0.72 to about 3.42.

[0061] Advantageously, the low friction surfaces allow smooth insertion of the enteral tube and easy removal of the introducer device without inadvertent removal or disturbance of the enteral tube or endotracheal tube. Additionally, or alternatively, the device may be used with medical grade lubricant, e.g., lubricating jelly, to lower the functional coefficient of friction.

[0062] Preferably, the introducer device comprises rounded edges to prevent unnecessary trauma to the patient’s tissues.

[0063] Preferably, all or some of the introducer device is formed from material sufficiently soft enough to prevent injury to the patient’s tissue.

[0064] In some embodiments, the introducer device may be made of one or more materials, preferably wherein the device has a rigid core, e.g., made of a material having a hardness on the Shore A scale in the range of from of about 50A to about 60A, particularly preferably wherein the core is provided with a softer exterior, e.g., an overmold having a hardness in the range of from of about 0 to 30A. In this embodiment, the device is rigid enough to manipulate into place and does not deform when positioned and the surfaces which actually contact the patient’s mucosa are softer and less likely to cause trauma.

[0065] Preferably, the introducer device is formed of a material that enables an enteral tube to glide through the guiding channel of the introducer device.

[0066] Preferably, the introducer device is formed from biocompatible materials to prevent harm to the patient’s tissue.

[0067] Preferably, the introducer device is formed from styrene ethylene butylene styrene (SEBS) or thermoplastic polyurethane (TPU).

[0068] Preferably, the introducer device is shaped to conform to the anatomy of the pharynx area, in particular to conform with one or more of the oropharynx and the hypopharynx.

[0069] Advantageously, the conformity of the shape of the introducer device to the pharynx prevents damage to the patient’s tissue during use of the device.

[0070] In a preferred embodiment, the introducer device is free from moving parts.

[0071] In a preferred embodiment, the introducer device comprises a handle to facilitate handling and insertion of the introducer device, preferably wherein the handle is at the proximal end of the introducer device and the functional head portion at the distal end of the introducer device.

[0072] Preferably, the handle is formed of one or more materials suitable to provide sufficient stiffness to enable manoeuvrability of the introducer device such as plastic, preferably acrylonitrile butadiene styrene, nylon or polycarbonate.

[0073] Alternatively, or additionally, the handle may comprise steel, e.g. stainless steel, to provide stiffness to the introducer device.

[0074] The handle and functional head portion may be connected via bonding, injection moulding processes such as over moulding, or via any other suitable method.

[0075] In alternative embodiments, the handle may be removable, preferably wherein the removable handle is made of steel. In such embodiments, the handle may be attached to a single use disposable or reusable functional head portion portion, preferably wherein the removable handle is made of steel.

[0076] In a particularly preferred embodiment, the introducer device comprises a handle at the proximal end of the elongate body and a functional head portion at the distal end of the elongate body, the functional head portion having an anterior side comprising a recessed area located between two raised portions and an opposing posterior side comprising an exposed guiding channel between two protuberances, wherein each raised portion connects with an adjacent protuberance to form a convex lateral side of the head portion. The guiding channel is open posteriorly and the recessed area is open anteriorly.

[0077] In an alternative embodiment, the introducer device comprises an elongated open airway along the entire length of the device on the side opposite the guiding channel to enable airflow in the absence of an endotracheal tube.

[0078] Advantageously, this enables the introducer device to be used on patients who are breathing independently, i.e., not intubated.

[0079] The open airway may be in the form of a channel or other concavity suitable for enabling free airflow. For example, the elongate body may be U-shaped.

[0080] In this embodiment, the recessed area is part of the elongated open airway enabling airflow in the absence of an ET tube and such introducer devices may be used whether or not an endotracheal tube is present.

[0081] In a particularly preferred embodiment, the introducer device comprises a handle and an elongated open airway extending between the distal end of the functional head portion and the handle.

[0082] The skilled person will understand that where the same feature has been referenced in different aspects of the invention, this feature comprises the same parts and operates in the same way unless otherwise stated. Different aspects of the invention can be combined unless otherwise stated.

[0083] Brief of the

[0084] Certain preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0085] Figure 1 is a perspective view of a preferred introducer device according to the invention;

[0086] Figure 2 is a plan view of the anterior side of the introducer device of Figure 1 ;

[0087] Figure 3 is a perspective view of the posterior side of the introducer device of Figure 1 ;

[0088] Figure 4 is an enlarged view of the distal end of the posterior side of the introducer device of Figure 1 ;

[0089] Figure 5 is a perspective view of the distal end of the introducer device of Figure 1 in use with a nasogastric tube;

[0090] Figure 6 is a second perspective view of the distal end of the introducer device of Figure 1 in use with a nasogastric tube;

[0091] Figure 7 is a side view of the introducer device of Figure 1 in use with a nasogastric tube;

[0092] Figure 8 is a perspective view of the distal end of the anterior side of the introducer device of Figure 1 in use with an endotracheal tube; Figure 9 is a side view of the introducer device of Figure 1 in use with a nasogastric tube and an endotracheal tube;

[0093] Figure 10 is a perspective view of the introducer device of Figure 1 in use with a nasogastric tube and an endotracheal tube;

[0094] Figure 11 is a perspective view of the introducer device of Figure 1 in use;

[0095] Figure 12a is a cross section of the throat of a patient without intubation and without the introducer device of Figure 1 ;

[0096] Figure 12b is a cross section of the throat of an intubated patient where the introducer device of Figure 1 is in use;

[0097] Figure 13 is a perspective view of the introducer device of Figure 1 in use on a patient where the nasogastric tube has slipped out of the guiding channel;

[0098] Figures 14a shows the anterior side of an alternative preferred introducer device according to the invention;

[0099] Figure 14b shows the posterior side of the introducer device of Figure 14a in use with an enteral tube; and

[0100] Figure 14c shows a side view of the introducer device of Figure 14a.

[0101] Detailed Description

[0102] In overview, an introducer device for aiding the insertion of an enteral tube into a patient is provided which may be subsequently removed from the patient independently from the enteral tube, the introducer device comprising a guiding channel for guiding the enteral tube into the oesophagus of the patient.

[0103] Various embodiments of the present invention will be described in detail with reference to the drawings, where like reference numerals represent like parts and assemblies throughout the several views. It will be appreciated that the invention should not be construed to be limited to the examples, which are now described; rather, the invention is construed to include any and all applications provided herein and all equivalent variations within the skill of the ordinary artisan.

[0104] Referring to the drawings, there is shown a preferred introducer device according to the invention, generally indicated by reference numeral 1 , comprising a guiding channel 3 for guiding an enteral tube 30 into the oesophagus of a patient 2. As will be explained in further detail, introducer device 1 can be removed from the patient independently of enteral tube 30. This is in comparison to other introducer devices which only enable enteral tubes to remain inserted while said known introducer device is inserted. Enteral tube 30 illustrated in the drawings is a nasogastric (NG) tube. Introducer device 1 is primarily for use in inserting NG tubes. However, this is not to be considered limiting and introduced device 1 can be used to guide any type of enteral tube.

[0105] Referring to Figures 1 to 13, preferred introducer device 1 has an elongate body 22 with handle 20 at the proximal end and functional head portion 10 with guiding channel 3 at the distal end.

[0106] The proximal end of head portion 10 is connected to elongate body 22 and the distal end of head portion 10 comprises tip 13.

[0107] Head portion 10 has an anterior side 7 which, as can be seen in Figure 11 , in use, faces the tongue of patient 2 on insertion of introducer device 1 and an opposing, posterior side 5 which, in use, faces the roof of the patient’s mouth 50 and the back of the patient’s pharynx 44.

[0108] Indented area 11 is located on anterior side 7 of head portion 10 and is configured to fit around endotracheal tube 33. As shown, for example in Figure 2, area 11 is open at tip 13, i.e., the indent extends all the way to tip 13 and is not obstructed.

[0109] Guiding channel 3 is located on posterior side 5 of head portion 10 and is in the form of a tapered trough with two open ends, proximal open end 3c a distal open end 3b, to enable the passage of enteral tube 30 therethrough.

[0110] The width of functional head portion 10 gradually increases away from tip 13 with the widest part of head portion 10 being wider than the patient’s upper oesophageal sphincter. As illustrated in Figure 11 , this ensures that, in use, introducer device 1 reaches the optimum position within the patient’s pharynx 44, ideally wherein tip 13 reaches the area of the C5 or C6 intervertebral disc, and prevents introducer device 1 from being progressed too far down the throat the patient 2.

[0111] Guiding channel 3 is open in cross-section and curved to correspond to the shape of enteral tube 30. In particular, as illustrated in Figure 3, guiding channel 3 is open posteriorly through approximately 180° in cross-section at end 3b adjacent tip 13.

[0112] Guiding channel 3 tapers towards tip 13. In other words, proximal end 3c of guiding channel 3 is wider than distal end 3b, as illustrated in Figures 3 to 6. The open taper of guiding channel 3 enables guiding channel 3 to catch the end of enteral tube 30 during use of introducer device 1 as enteral tube 30 is being inserted into pharynx 44 or other suitable area of patient 2 and to funnel enteral tube 30 towards the distal end of introducer device 1 and thereby towards the patient’s oesophagus 48.

[0113] As shown in the Figures, especially in Figures 6, 7 and 12b, bulges 9a, 9b protrude from posterior side 5 either side of guiding channel 3 for engagement during use of introducer device 1 with a patient’s tissue 47, depicted schematically in Figures 5 and 6 by line 47, to form a closed channel between guiding channel 3 and tissue 47. In other words, bulges 9a and 9b engage with tissue 47 which forms a wall posteriorly to form a closed funnel with tapered guiding channel 3. This prevents the enteral tube 30 slipping out of guiding channel 3 or damaging tissue either side of guiding channel 3.

[0114] Due to the tapered shape of guiding channel, in use, guiding channel 3 will not be closed 360° around the enteral tube 30. This enables introducer device 1 to be removed from patient 2 independently from enteral tube 30 without the need to split or cut introducer device 1 prior to said independent removal.

[0115] Introducer device 1 is curved along its length, said curvature conforming to the anatomy of the patient’s pharynx area as shown in Figure 11 to aid positioning of introducer device 1.

[0116] In the preferred embodiment shown in Figures 1 to 13, the length of introducer device 1 is approximately 180 mm from its proximal end to tip 13.

[0117] As shown in Figure 11, in use, introducer device 1 funnels enteral tube 30 in a direction from the pharynx 44 to the upper oesophagus. Introducer device 1 is shaped for engaging with the pharynx 44 to be seated correctly in the pharynx 44 and to fill the space of the pyriform sini 46a, 46b to prevent the enteral tube 30 from entering this area should it slip out of guiding channel 3.

[0118] As shown in Figure 12b, shoulders 18a and 18b each independently extend laterally away from bulges 9a, 9b and guiding channel 3 to block access to the pyriform sini 46a, 46b of patient 2 in use of introducer device 1 and to form the lateral sides of functional head portion 10. Shoulders 18a, 18b extend from posterior side 5 and are curved towards anterior side 7 to conform with the shape of pharynx 44 and to ensure optimum engagement with the patient’s tissue 47 such that enteral tube 30 is pressed against the back wall of pharynx 44 should it slip out of guiding channel 3, as illustrated in Figure 13. Conformity of the shape of shoulders 18a, 18b to pharynx 44 prevents shoulders 18a and 18b from causing damage to the patient.

[0119] Introducer device 1 is suitable for causing anterior displacement of larynx 43 to ensure that guiding channel 3 is the only accessible path to oesophagus 48 for enteral tube 30. Introducer device 1 does this by engaging with larynx 43 to push larynx 43 in an anterior direction, away from spine 52 of patient 2. Introducer device 1 enables this automatically, or manually, or both automatically and manually.

[0120] Head portion 10 is thinnest at tip 13 and increases in depth towards the distal end of introducer device 1 such that head portion 10 is substantially wedge shaped. This wedge shape allows introducer device 1 to gradually push the larynx 43 anteriorly, in use, and force collapsed oesophagus 48 to open. As illustrated in Figure 12b, head portion 10 is substantially in the shape of the numeral 3 in cross section at the widest part as the depth of functional head portion 10 increases from its central line where the guiding channel 3 is located towards shoulders 18a, 18b which form the lateral sides of functional head portion 10.

[0121] Introducer device 1 can also be pulled anteriorly, in use, to manually force larynx 43 away from spine 52 to enable opening of the oesophageal inlet and create a passageway for enteral tube 30 via guiding channel 3.

[0122] As illustrated, functional head portion 10, in particular, a portion of anterior side 7 extends over the entry point of larynx 43 to prevent entry of enteral tube 30 into larynx 43.

[0123] Indented area 11 is shaped to accommodate an endotracheal (ET) tube 33 already present in mouth 50 and pharynx 44 of patient 2. ET tube 33 can thus be used as a guide and point of centralisation to enable correct positioning of introducer device 1 within pharynx 44. Area 11 is a concavity formed on anterior side 7 of head portion 10 and is shaped to correspond to the outer curvature of endotracheal tube 33. Area 11 extends between ridges 19a, 19b and is open anteriorly to enable easy placement over endotracheal tube 33. This further enables easy removal of introducer device 1 independently from endotracheal tube 33.

[0124] Handle 20 provides sufficient stiffness to enable manoeuvrability of introducer device 1.

[0125] Handle 20 and functional head portion 10 of introducer device may be connected via bonding, injection moulding processes such as over moulding or via any other suitable method. In some embodiments, handle 20 is removable to allow for attachment to a single use disposable or reusable functional head portion 10.

[0126] Introducer device 1 has rounded edges to prevent unnecessary trauma to a patient’s tissues. As well as this, all or some of introducer device 1 is formed from material sufficiently soft enough to prevent injury to the patient’s tissue. The external surfaces of head portion 10 are of a low friction coefficient to facilitate easy insertion and removal of introducer device 1 and to prevent resistance to enteral tube 30 throughout insertion. An example of a suitable material would be soft rubber or silicone. The low friction surfaces allow smooth insertion of enteral tube 30 and easy removal of introducer device 1 without inadvertent removal of enteral tube 30. In particular, introducer device 1 is formed of material that enables enteral tube 30 to glide through guiding channel 3 of introducer device 1. Introducer device 1 is capable of being removed without disturbing enteral tube 30 or ET tube 33, if present.

[0127] For the avoidance of doubt, guiding channel 3 is recessed with respect to bulges 9a, 9b and area 11 is recessed with respect to ridges 19a, 19b.

[0128] In the preferred embodiment shown in Figures 1 to 13, introducer device 1 is solid rather than hollow. Functional head portion 10 is overmoulded over a portion of curved elongate body 22 at a distal end thereof and the proximal end of elongate body 22 is provided with curved handle 20. As shown by the dotted lines in Figures 1 to 6, elongate body 22 has a curved core support section covered by a shorter, wider section under the overmoulding such that introducer device 1 is substantially S-shaped.

[0129] In this preferred embodiment, functional head portion 10 has an alternating depth along its length such that it is substantially wedge shaped, the depth gradually increasing from about 22mm at tip 13 until it reaches a maximum depth of 11mm and then gradually decreasing to match the depth of elongate body 22. This enables gradual anterior displacement of the larynx as the introducer device progresses down the pharynx.

[0130] Also, in the preferred embodiment shown, the width of functional head portion gradually increases from tip 13 at the distal end to a maximum width of about 43mm to prevent over insertion of the introducer device. That is, the increasing width causes functional head portion 10 to abut against the sides of the patient’s pharynx 44 thereby preventing introducer device 1 from being progressed too far down the throat or oesophagus of patient 2.

[0131] Introducer device 1 is suitable for insertion into the mouth of a patient and can be used to guide the insertion of nasoenteral tubes such as nasogastric tubes and oroenteric tubes. Therefore, introducer device 1 can assist operators inserting enteral tubes via the nasal or oral route.

[0132] In use of introducer device 1 in anesthetised and intubated patients, an operator holds endotracheal tube 33 securely with one hand, preferably the non-dominant hand, to one side of the patient’s mouth. Introducer device 1 is held in the operator’s other hand, preferably the operator’s dominant hand, and inserted on the opposite side of the mouth to ET tube 33. Ridges 19a, 19b and open area 11 on anterior side 7 locate introducer device 1 onto the back of ET tube 33. The operator then advances introducer device 1 posteriorly to the back of the mouth, at which point device 1 is directed distally into the hypopharynx. Introducer device 1 then sits centrally using existing ET tube 33 as a guide. Introducer device 1 will come to rest in the hypopharynx with tip 13 of introducer device 1 located in the patient’s upper oesophagus, in the area of the C5 or C6 intervertebral disc. At this point introducer device 1 sits stably in its position.

[0133] Enteral tube 30 can then be inserted via the nose into the oropharynx of the patient. If it is an NG tube, like that illustrated in the drawings, it will be inserted via one of the nostrils into the oropharynx as standard. The tip of the enteral tube 30 will meet introducer device 1 at guiding channel 3 on posterior side 5 of introducer device 1 . The operator will continue to advance enteral tube 30 until the desired distance is reached. At this point, the position can be confirmed using standard methods (e.g., pH testing) and introducer device 1 can be removed by reversing the steps of the insertion procedure, taking care not to change the position of ET tube 33 in the trachea. If the enteral tube is to be inserted orally, it is inserted simultaneously with introducer device 1 , i.e., a portion of the tube is placed in guiding channel 3 before introducer device 1 is inserted.

[0134] An alternative preferred introducer device 100 is illustrated in Figures 14a to 14c. Introducer device 100 differs from introducer device 1 in that the elongate body comprises an open airway 98 to enable airflow (indicated by dashed line 99) in the absence of an endotracheal tube. The open airway runs along the full length of the posterior side of introducer device 100 from the proximal end to the distal tip, enabling introducer device 100 to be used on patients who are breathing independently. Introducer device 100 is inserted and used on non-intubated patients in the same way as described above for introducer device 1 except that there is no endotracheal tube present. In this case, the open airway 101 enables airflow for inhalation and exhalation. There may be a requirement for the use of local anaesthetic prior to using device 100 and the mandible may be manually displaced forward using handle 20. It is to be understood that the invention is not limited to the specific details described herein which are given by way of example only and that various modifications and additions are possible without departing from the scope of the invention as defined in the appended claims.

Claims

1. CLAIMS:

1. An introducer device for aiding the insertion of an enteral tube into a patient, the introducer device comprising an elongate body with a functional head portion for insertion into the patient’s mouth, the posterior side of the head portion being provided with a guiding channel for guiding the enteral tube into the oesophagus of the patient and the anterior side of the head portion being provided with a recessed area for accommodating an endotracheal tube present in the mouth, pharynx and trachea of the patient, wherein the guiding channel is an exposed channel to enable removal of the introducer device independently of the enteral tube and endotracheal tube.

2. The introducer device as claimed in claim 1 , wherein the head portion comprises a protuberance either side of the guiding channel for engaging with the patient’s tissue to form a closed channel between the guiding channel and the patient’s tissue.

3. The introducer device as claimed in claim 2, wherein the protuberances comprise extension portions which extend laterally away from the guiding channel to block access of an inserted enteral tube to the patient’s pyriform sini in use of the device.

4. The introducer device as claimed in claim 2 or claim 3, wherein the recessed area is located between raised portions on the anterior side of the introducer device, wherein the raised portions are a continuation of the protuberances adjacent the guiding channel such that the lateral sides of the functional head portion are convex.

5. The introducer device as claimed in any one of the preceding claims, wherein the depth of the head portion gradually increases away from the distal end of the introducer device to enable gradual anterior displacement of the larynx as the introducer device progresses down the oesophagus.

6. The introducer device as claimed in any preceding claim, wherein the guiding channel tapers towards the distal-most point of the head portion.

7. The introducer device as claimed in any preceding claim, wherein the width of the functional head portion gradually increases away from the distal end of the introducer device to prevent over insertion of the introducer device.

8. The introducer device as claimed in any preceding claim, wherein the introducer device is shaped to correspond to the anatomy of the pharynx area to aid positioning of the introducer device, preferably shaped to conform with one or more of the oropharynx and the hypopharynx.

9. The introducer device as claimed in any preceding claim, wherein the introducer device comprises a handle, wherein the functional head portion is at a distal end of the elongate body and the handle at a proximal end of the elongate body.

10. The introducer device as claimed in claim 9, wherein the handle is removable to allow for attachment of the handle to a single use disposable or reusable functional head portion.

11. The introducer device as claimed in any preceding claim, wherein the introducer device is substantially S-shaped.

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