Field of the Invention

[0001] The present invention relates to a ventilating apparatus for safely intubating patients during surgical procedures. The apparatus is an expandable intubation device comprising an expandable endotracheal tube compressed with a perforated sheath that is removed after the device is inserted into a patient. As the sheath is removed, the tube within the device expands within the trachea and assumes its fully deployed position.

Background of the Invention

[0002] Endotracheal intubation refers to the ventilation of an unconscious patient during surgery. A tube is inserted into a patient's trachea to protect the airway and mechanically ventilate the patient. Conventional tubes typically used for these procedures are difficult to maneuver into the larynx because they are rigid. Thus, it becomes difficult to ventilate a patient because of the challenge accompanying inserting a conventional tube into a patient's trachea to provide airway control.

[0003] Medical professionals also face challenges when intubating patients because of tube placement and visual obstructions. According to related art devices and procedures, difficult airways are sometimes visualized with a glide scope during intubation; this improves visualization, but does not aid in tube placement.

[0004] A need exists for an intubation device that can be inserted easily into the patient's trachea without requiring additional visual aids.

Summary of the Invention

[0005] Accordingly, an object of the invention is to provide an

endotracheal tube for effectively and safely intubating patients during surgical procedures. [0006] Another object of the invention is to provide a malleable endotracheal tube for easily passing through a patient's vocal cords without the need for a separate stylet.

[0007] A further object of the invention is to provide an expandable endotracheal tube within an overlying sheath that is removed during or after intubation of a patient.

[0008] Still another object of the invention is to provide an expandable endotracheal tube within an overlying perforated sheath, wherein the sheath is connected to and removed by a sheath removing element during or after intubation of a patient.

[0009] In accordance with these objects, in one embodiment the present invention is directed to an expandable and malleable endotracheal tube that is configured to expand after intubation of a patient. According to a further embodiment, the tube is flexible enough to be easily inserted into a patient's trachea during surgical procedures.

[0010] In a particular embodiment, the present invention is directed to an expandable intubation device, comprising: an expandable endotracheal tube having a body, a distal end, a proximal end opposite the distal end, and a first size; a sheath disposed over a substantial portion of the length and the outer surface of the expandable tube; and a sheath removing element connected to the sheath for removing the sheath wherein the tube adopts a second size.

[0011] In preferred aspects of this embodiment, the expandable intubation device includes a vent adapter for connecting the proximal end of the expandable tube to an air source.

[0012] In preferred aspects of this embodiment, the expandable tube includes a cuff balloon for fixing the distal end within a body lumen.

[0013] In preferred aspects of this embodiment, the first size represents a compressed diameter.

[0014] In preferred aspects of this embodiment, the second size represents an expanded diameter. [0015] In preferred aspects of this embodiment, the sheath includes a plurality of perforations extending along a longitudinal axis thereof.

[0016] In preferred aspects of this embodiment, the body of the

expandable tube is rubber or plastic.

[0017] In preferred aspects of this embodiment, the body of the

expandable tube is a rubber mesh or a plastic mesh.

[0018] In preferred aspects of this embodiment, the second size is larger than the first size.

[0019] By forming the expandable intubation device in this manner, the expandable endotracheal tube having a plastic or rubber mesh body expands upon insertion of the device and removal of the overlying sheath. An overlying sheath is removed upon pulling of the sheath removing element to reveal the expandable endotracheal tube that expands to a fixed diameter.

[0020] As used in this application, the terms "top", "bottom", and "side" are intended to facilitate the description of the expandable intubation device, and are not intended to limit the description of the expandable intubation device to any particular orientation.

[0021] Other objects, advantages, and salient features of the present invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses a preferred embodiment of the invention.

Brief Description of the Drawings

[0022] Referring to the drawings which form a part of this disclosure:

[0023] FIG. 1 is a front elevational view of the expandable intubation device prior to deployment with the overlying sheath fully attached

according to the present invention;

[0024] FIG. 2 is a front elevational view of the device as seen in FIG. 1 with the sheath partially removed and a cuff balloon shown at the distal end of the endotracheal tube; and

[0025] FIG. 3 is a front elevational view of the device of FIGS. 1 and 2 with the sheath completely removed and the tube fully deployed. Detailed Description of the Invention

[0026] Referring to Figures 1-3, an expandable intubation device 10 according to the present invention is used for intubating patients. The device 10 is an elongated cylinder comprising a distal end 12, a proximal end 14 opposite the distal end 12, an expandable endotracheal tube 16, an overlying sheath 20 that compresses the expandable endotracheal tube 16 within it, and a sheath removal element 24 attached to the sheath 20.

When the sheath 20 is removed from the expandable endotracheal tube 16 using the sheath removal element 24, the expandable endotracheal tube 16 expands to occupy a patient's trachea during intubation.

[0027] The expandable endotracheal tube 16 may be made of any suitable material for use as an endotracheal tube and that has the property of being compressible within the sheath 20, and expandable upon removal of the sheath 20. In one aspect, the expandable endotracheal tube 16 is made of a rubber or plastic mesh material which makes it easily compressible under the sheath 20, yet expandable and sturdy enough to keep a patient's airway open during intubation when the sheath 20 is removed.

[0028] As illustrated in Figure 1 , the expandable endotracheal tube 16 is not visible within the device 10 but instead is covered by the sheath 20 prior to deployment into a body lumen. The sheath 20 can be made of any type of material that is sturdy enough to compress the expandable endotracheal tube 16 and easily removable once the device 10 is inserted into a body lumen. For example, the sheath 20 can be made of plastic, rubber, metal, latex, fiber, or any appropriate material known to one of ordinary skill in the art.

[0029] The sheath 20 keeps the expandable endotracheal tube 16 in an undeployed state until the sheath 20 is removed. The sheath 20 may include a plurality of perforations 22 along a longitudinal axis thereof. The perforations 22 are in the material comprising the sheath 20 and aid in the removal of the sheath 20 and expansion of the expandable endotracheal tube 16. The perforations 22 may extend along a portion of the sheath 20 or continuously from the distal end 12 to the proximal end 14 of the sheath 20. A sheath removal element 24 is attached at a position along the length of the sheath 20 for engaging the perforations 22.

[0030] In the preferred embodiment, the sheath 20 includes a plurality of perforations 22 extending along the entire length of the sheath 20. The sheath removal element 24 may be attached at a position anywhere between the distal end and mid-length of the sheath 20. The user engages the sheath removal element 24 by pulling it towards the proximal end of the sheath 20, thus causing the sheath removal element 24 to separate the perforations 22. When the sheath removal element 24 is pulled from the distal end of the sheath 20 towards the proximal end of the sheath 20, the sheath 20 is removed. Upon removal, the expandable endotracheal tube 16 expands.

[0031] Figure 2 illustrates the mid-deployment positioning of the device 10 as the expandable endotracheal tube 16 expands when the sheath 20 is partially removed. This takes place after insertion into the body lumen.

More specifically, when a medical professional pulls the sheath removal element 24 away from the distal end 12 and towards the proximal end 14 of the device 10, the perforations 22 along the exterior surface of the sheath 20 separate. This causes the diameter of the expandable endotracheal tube 16 to expand from its compressed shape to its normal, expanded size wherein the normal, expanded size is defined as that necessary for air delivery to a patient.

[0032] As seen in Figures 2-3, the device 10 further includes a cuff balloon 30 on the outer distal end of the expandable endotracheal tube 16. The cuff balloon 30 is a bag-like structure that inflates or deflates and is disposed adjacent the distal end 12 of the expandable endotracheal tube 16. When the cuff balloon 30 is inflated, it creates a seal between an inner wall of the trachea and the other surface of the expandable endotracheal tube 16.

[0033] The device 10 also includes a catheter 34. The catheter 34 operably connects the cuff balloon 30 and a cuff segment 32. The catheter 34 is positioned along the inner surface of the device 10 and the outer surface of the expandable endotracheal tube 16. The cuff segment 32 may be connected to a device that functions to inflate the cuff balloon 30.

[0034] Turning to Figure 3, when the sheath 20 is completely removed and the expandable endotracheal tube 16 is in its fully deployed state, a vent adapter 40 may be attached to the proximal end 14 of the expandable endotracheal tube 16. The vent adapter 40 creates an airtight seal between the expandable endotracheal tube 16 and an air supply source (i.e., anesthetic gas, oxygen, medical gas, etc.) for introduction to a patient during surgical procedures.

[0035] The skilled artisan will understand that the means used to remove the sheath 20 from the device 10 is not particularly important. However, as disclosed herein a combination of perforations 22 along the length of the sheath 20, and a sheath removal element 24, is an exemplary means for removing the sheath 20 and allowing the expandable endotracheal tube 16 to full expand. As discussed above, the sheath removal element 24 is preferably attached to a region of the sheath between the distal end and a mid-point along the length of the sheath. The sheath removal element 24 may be attached to a short length of this region, or it may be attached over the entire length of this region. The sheath may be attached to the

perforations 22 alone, a non-perforated region alone, or a combination of the perforations 22 and a non-perforated region of the sheath 20.

[0036] In an alternative embodiment, the sheath removal element 24is attached along 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or 100% of the length of the sheath 20, to the perforations 22 alone, a non-perforated region alone, or a combination of the perforations 22 and a non-perforated region of the sheath 20. Likewise, the perforations 22 can extend along a portion of the sheath body (e.g., 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%) or the entire length of the sheath 20. The perforations 22 need not necessarily extend along the longitudinal axis, but may extend at an angle to the length of the sheath 20. Once the perforations 22 separate, the sheath removal element 24 and sheath 20 are pulled free from the patient and the expandable endotracheal tube 16expands.

[0037] In another embodiment, the sheath removal element 24 is pulled along a substantial length (or the entire length) of the sheath 20 to split the sheath 20 along the perforations 22, and sheath removal element 24 is removed from the patient. Once the sheath removal element 24 is removed, the sheath 20 is separately removed.

[0038] In a further embodiment, the sheath 20 does not include any perforations. The sheath removal element 24 is pulled and the sheath 20 peels back along the expandable endotracheal tube 16, from distal to proximal, and is removed from the device 10 and the patient, allowing the expandable endotracheal tube 16 to expand.

[0039] While one embodiment has been chosen to illustrate the invention, it will be understood by those skilled in the art that various changes and modifications can be made therein without departing from the scope of the invention as defined in the appended claims.