A double cannula tracheostomy tube

[001] Technical field of the invention

[002] The present invention relates to a surgical device more specially a tracheostomy tube for insertion through an incision on the anterior portion of the neck and opening a direct airway through an incision in the trachea or windpipe. The tracheostomy tube assists breathing in a patient.

[003] Background of the invention

[004] The trachea or windpipe is a wide, hollow tube that connects the larynx or voice box to the bronchi of the lungs. It is an integral part of the body's airway and has the vital function of providing air flow to and from the lungs during respiration. The trachea ends in the thorax where it splits into the left and right bronchi, which continue onward toward the lungs.

[005] Trachea comprises a thin, membranous wall with C-shaped rings of cartilage embedded into it. Usually, 16-20 cartilage rings are stacked along the length of the trachea, with narrow membranous regions spaced between the cartilage rings. The open ends of the cartilage rings face the posterior of the trachea near the esophagus.

[006] Usually, the airways carry oxygen-rich air into the lungs. In addition, they also carry carbon-dioxide, waste gas out of the lungs. Air enters into the body through nose or mouth. The air travels through the larynx and down the windpipe, thus helping the person to breath.

[007] The damage to trachea results in breathing difficulties in human. The surgical procedure involves the insertion of tracheostomy tube to aid in artificial breathing. Tracheotomy is a surgical procedure, which consists of making an incision on the anterior portion of the neck and opening a direct airway through an incision in the trachea. The resulting hole is called as stoma or tracheostomy, and serves independently as an airway or as a site for a tracheostomy tube to be inserted. Tracheostomy tube allows a person to breath without the use of nose or mouth.

[008] Generally, people who have conditions that interfere with coughing or blocking in the upper airways need tracheostomies. Coughing is a natural reflex that protects the lungs. It helps to clear the mucus and bacteria from the airways.

[009] The Patent Application "US4340046A" titled "Static tracheostomy tube" discloses an improved tube for providing a reliable airway for patients requiring mechanical assistance in breathing. The tracheostomy tube comprises a flexible tube to the neck, an encircling pressure cuff, removably insertable malleable obturator and a self-locking neck plate to secure the tube of the neck. The invention relates to tracheostomy, an operation for providing an airway to patients requiring mechanical assistance in breathing and for conduction of anesthetic gas when the tube is placed in the trachea through the mouth or nose.

[0010] The Patent Application "US3889688A" titled "tracheostomy tube with novel retaining means " discloses a tracheostomy tube for insertion through the soft tissue of the neck and an opening in the tracheal wall and having an inflatable cuff to seal the tube with within the trachea as well as a second inflatable device surrounding the tube at a point closely adjacent the opening through which the tube passed inside the trachea. The second device is inflatable to a diameter greater than the opening to prevent withdrawal of the tube until the second device has been deflated. It is also provided with an adjustable shield for securing the tube on the outside of the neck.

[0011] The Patent Application "US4877025A" titled "Tracheostomy valve apparatus " discloses a fenestrated tube valve assembly removably insertable in the tracheostomy stoma and having an enlarged flange abuttable against the skin of the throat. The tube further comprises a smaller diameter flange in the trachea and abuttable against the tissue surrounding the opening of the stoma to the trachea, a tube part extendable through the stoma and joined to flanges, and an inflatable annular diaphragm joined to flanges that extends through the tube part and in conjunction with the inner peripheral wall of the tube part forms an inflatable chamber. [0012] The state of art discloses different types of tracheostomy tubes, which are provided with single cannula, which leads to leakage. The tube is supplied with an obturator and a tracheal cuff, which allows separation of the lungs from pharyngeal secretions and are associated with leakage of secretions past the cuff. Further, uncuffed tubes are available for patients requiring long-term tracheostomy who have reasonable laryngeal function with no aspiration but these tubes are unable to clear their secretions. However, most of the patients are not able to speak when the tracheostomy tubes are in situ.

[0013] Hence, there is a need for a tracheostomy tube with double cannula, which is beneficial in case of tube obstruction, such that the complications arising from the obstruction are reduced. In addition, there is also a need for the tracheotomy tube which allows the patients to speak when the tube is in place.

[0014] Summary of the invention

[0015] The present invention relates to a tracheostomy tube for insertion through an incision on the anterior portion of the neck and for opening a direct airway through an incision in the trachea or windpipe. The tracheostomy tube assists a patient in breathing.

[0016] The present invention discloses a double cannula tracheostomy tube, which overcomes the drawbacks of the conventional tracheostomy tubes with respect to the leakage or blockade of the secretions, while allowing the patients to maintain speech while the tracheotomy tube is in place.

[0017] The tracheostomy tube of the present invention is a double cannula tube comprising an inner cannula, an outer cannula, a plurality of hinges, a circular ring, a knob and a cuff. The outer cannula is arc shaped hollow tube with openings at both the ends and is inserted into the trachea. The outer cannula houses an oval opening at the junction of the 1/3 rd of the proximal (horizontal) and

2/3 rd of the distal end (vertical). The inner cannula similarly comprises an oval portion with multiple tiny circular fenestration coinciding with the oval opening in outer cannula, which facilitates breathing and speech of the patient. The inner tube when inserted into the outer cannula, fits into the outer cannula snuggly with the fenestrated end of the inner tube coinciding with the oval end of the outer cannula. This arrangement facilitates breathing when the inner tube is removed for cleaning during partial or total blockage thus obviating the need for suctioning on emergency basis. During such period that inner tube is removed, the large oval opening in outer tube facilitates improved breathing. The inner tube with smaller opening prevents thick secretion from larynx or food pipe to enter the tracheotomy tube. The upper end of the inner cannula facilitates placing the knob to aid decannulation and mounting. The hinge 1 anchors the tube to the neck of the patient and is movable in function. The hinge 2 is fixed to the tracheostomy tube by a circular ring. The circular ring stabilizes the hinge 2 attached to the tracheostomy tube. The knob is placed in the anterior portion of the tracheostomy tube. The cuff, which is an optional embodiment of the tracheostomy tube is located on the lower outer cannula and blocks any air from flowing around the tube. The tracheostomy tube is fenestrated with a plurality of small openings on the inner tube, which allows the air to pass through the larynx for allowing the patient to speech.

[0018] Usually, the diameter of the tracheostomy tube should be two-third or three-fourth of the diameter of the trachea and the size varies with the individual. The inner cannula is removed during blockage of any secretions without requirement of suctioning and replaced after cleaning. The tracheostomy tube of the present invention also functions as a speech device allowing the patient to speak. The tracheostomy tube is also useful in removal or suction of mucus from the airway.

[0019] Brief description of drawings

[0020] FIG 1 illustrates the lateral view of the tracheostomy tube. [0021] FIG 2 illustrates the front view of the tracheostomy tube. [0022] Detailed description of the invention

[0023] In order to make the matter of the invention clear and concise, the following definitions are provided for specific terms used in the following description. [0024] The term "Tracheostomy" refers to a dental instrument used in grasping or extracting the tooth.

[0025] The term "Decannulation" refers to a process whereby a tracheostomy tube is removed once patient no longer needs it. [0026] The present invention relates to a tracheostomy tube to assist a patient in breathing effectively. The tracheostomy tube of the present invention is a double cannula tube. The double cannula tube comprises inner cannula residing inside the outer cannula and is removable.

[0027] FIG 1 illustrates the lateral view of the tracheostomy tube. The tracheostomy tube (100) comprises an inner cannula (101), an outer cannula (102), a plurality of hinges (103, 104), a circular ring (105), a knob (106) and a cuff (107). The outer cannula (102) is the main embodiment of the tube (100) that is inserted into the trachea and is arc shaped. The outer cannula (102) is an arc shaped hollow tube with openings at both the ends and is inserted into the trachea. The outer cannula (102) houses an oval opening at a junction of the 1/3 rd of the proximal (horizontal) end and 2/3 rd of the distal end (vertical) end to facilitate breathing and speech of the patient even when the inner cannula (101) is not in position. The inner cannula (101) is placed inside the outer cannula (102). The inner cannula (101) is replaceable in case of blockade or leakage. The inner cannula (101) comprises a plurality of fenestrations, which when inserted into the outer cannula (102), fits into the outer cannula (102). The position of the fenestrations on the inner cannula (101) coincides with the oval opening of the outer cannula (102). The length of the inner cannula (101) is larger than the outer cannula (102). The upper end of the inner cannula (101) facilitates placing the knob (106) to aid decannulation and mounting. The hinge 1 (103) anchors the tracheostomy tube (100) to the neck of the patient and is movable in function to support the neck movement of the patient. The hinge 2 (104) is fixed to the tracheostomy tube (100) by a circular ring (105). The circular ring (105) is made up of plastic to ensure durability. The circular ring (105) stabilizes the hinge 2 (104) attached to the tracheostomy tube (100). The knob (106) also called as stopper is placed in the posterior portion of the tracheostomy tube (100). The knob (106) allows hands-free speech by the patient and aids in decannulation. The presence of the cuff (107) is optional and the tracheostomy tube (100) is with or without the presence of the cuff (107). FIG la illustrates the tracheostomy tube (100) comprising the cuff (107). The cuff (107) is located on the lower outer cannula (102) and blocks any air from flowing around the tracheostomy tube (100). The cuff (107) assures oxygenation to the patient. FIG lb illustrates the tracheostomy tube (100) without the cuff (107).

[0028] FIG 2 illustrates the side view of the tracheostomy tube. The tracheostomy tube (100) is fenestrated with plurality of small openings (201) on the inner cannula (101). The openings (201) allow the air to pass through the larynx allowing the patient to speech. This encourages maximal airflow through the upper airways during speech and also allows assessment of the normal route of air passage during preparation for decannulation.

[0029] The size of the tracheostomy tube (100) varies with an individual and is proportional to the diameter of the trachea. Usually, the diameter of the tracheostomy tube (100) should be two-third or three-fourth of the diameter of the trachea and should not be wider than the requirement in order to minimize trauma to the tracheal wall and long term complications. In the present invention, a unique size tracheostomy tube is created based on analysis on 1000 tracheas to create a universal diameter that fits all the adult patients irrespective of age or sex. [0030] The inner diameter of the tracheostomy tube (100) influences the long- term breathing. The inner cannula (101) is removed independent of the outer cannula (102) during blockade of any secretions without requirement of suctioning and replaced after cleaning. During this period, the outer cannula (102) aids in breathing independent to the inner cannula (101). [0031] The tracheostomy tube (100) aids in breathing of the patient without using nose or mouth. Another advantage of the present invention is the presence of fenestra in the inner cannula (101), which functions as a speech device to let the air from the lung pass into the vocal cords allowing vibration and enables the patient to speak. The tracheostomy tube (100) is also useful in removal or suction of mucus from the airways.