Patent Application
20150122264
The present disclosure relates generally to the field of tracheal tubes and, more particularly, to a tracheal tube including an outer cannula with a curved distal end.
This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.
A wide variety of situations exist in which artificial ventilation of a patient may be desired. For short-term ventilation or during certain surgical procedures, endotracheal tubes may be inserted through the mouth to provide oxygen and other gasses to a patient. For other applications, particularly when longer-term intubation is anticipated, tracheostomy tubes may be preferred. Tracheostomy tubes are typically inserted through an incision made in the neck of the patient and through the trachea. A resulting stoma is formed between the tracheal rings below the vocal chords. The tracheostomy tube is then inserted through the opening. In general, two procedures are common for insertion of tracheostomy tubes, including a surgical procedure and a percutaneous technique.
One difficulty that arises in the use of tracheal tubes, and tracheostomy tubes in particular, is in comfortably inserting the tracheostomy tube into the patient. For example, the design of the tracheostomy tube, and in particular, the design of the distal end of the tracheostomy tube, may not allow for easy and comfortable insertion. There is a need, therefore, for improved tracheal tubes, and particularly for improved distal ends of tracheostomy tubes.
This disclosure provides a novel tracheal tube that facilitates insertion into a patient's trachea. The tracheal tube may be a tube with a separate inner cannula and outer cannula. The outer cannula may be curved and/or flexible for ease of insertion and patient comfort. In particular, the outer cannula may include a longitudinal axis that is curved. The outer cannula may include a tapered distal tip. In some embodiments, the tapered distal tip may be formed using a melt mold (e.g., a melt shell) having a tapered end. For example, a distal end of the outer cannula may be inserted into a melt mold, and a portion of the distal end of the outer cannula may be melted using heat applied to the melt mold to form a tapered distal tip. The melt mold may include a longitudinal axis that follows the curve of the longitudinal axis of the outer cannula. That is, the melt mold and/or the opening defined by the melt mold may have the same curvature of the outer cannula. In some embodiments, the melt mold may define an opening that includes a first portion that may surround the distal end of the outer cannula when the outer cannula is inserted into the melt mold and may define a second portion that may extend past the distal end of the outer cannula. For example, an interior cavity of the melt mold may taper towards a distal end such that the cavity in the second portion is thinner than a wall of the outer cannula and such that the distal end of the outer cannula cannot advance into the second portion of the melt mold. Additionally, a wall of the second portion of the melt mold may be tapered. In particular, the wall of the second portion may be tapered such that the second portion is narrower in diameter at its distal end than its proximal end. In some embodiments, the second portion of the melt mold may be asymmetrical such that the angle or degree of taper varies about the circumference of the second portion. This may be advantageous to facilitate the insertion of the tracheal tube into the patient's trachea and may be particularly advantageous for tracheostomy tubes that are percutaneously inserted. Further, the tapered second portion may provide a more secure fit around, as well as a smoother transition between, an obturator and/or an introducer that may be used with the tracheal tube.
Thus, in accordance with a first aspect, a method of manufacturing a tracheal tube assembly includes providing a cannula having a cut distal end. The method also includes inserting the cut distal end into a melt mold. The melt mold includes an interior cavity configured to surround the cut distal end when inserted. Additionally, a portion of the interior cavity includes a tapered region that tapers the cavity to a terminus extending beyond the inserted cut distal end. The cavity at the terminus is thinner than a wall of the cannula such that the cut distal end cannot advance into the terminus of the interior cavity when inserted. Additionally, the method includes applying heat to the melt mold and the inserted cut distal end to melt a portion of the cut distal end into the terminus of the interior cavity to form a tapered distal tip.
In accordance with another aspect, a tracheal tube assembly includes a cannula including a distal end. The assembly further includes a melt tip disposed on the distal end of the outer cannula. The melt tip includes a tapered cavity that extends past the distal end of the outer cannula. The tapered region narrows away from the distal end.
Also disclosed herein is a melt mold for a tracheal tube. The melt mold includes a proximal end including a proximal opening of an interior cavity. The melt mold also includes a closed distal end. Additionally, the melt mold includes an indent formed by the closed distal end and extending into the interior cavity to define an interior surface of the interior cavity. A first gap between the interior surface and an exterior wall of the melt mold is configured to permit insertion of a tracheal tube end into the cavity. A second gap between the interior surface and the exterior wall of the melt mold is configured to be smaller than the tracheal tube end to prevent advancement of the tracheal tube end into the second gap. The second gap terminates at the closed distal end.
Various aspects of the disclosed techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which:
One or more specific embodiments of the present techniques will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
The tracheal tubes as provided herein may be disposable or reusable, capable of providing differential mechanical ventilation to either or both lungs, and capable of supporting all other functions of standard tracheal tubes (e.g. sealing, positive pressure generation, suctioning, irrigation, drug instillation, etc). The tracheal tubes can be used in conjunction with all acceptable auxiliary airway devices such as (e.g. heat and humidity conservers, mechanical ventilators, humidifiers, closed suction systems, scavengers, capnometers, oxygen analyzers, mass spectrometers, PEEP/CPAP devices, etc). Furthermore, although the embodiments of the present disclosure illustrated and described herein are discussed in the context of tracheal tubes such as tracheostomy tubes, it should be noted that presently contemplated embodiments may include a tracheal tube assembly including an outer cannula with a tapered distal end portion used in conjunction with other types of airway devices. For example, the disclosed embodiments may be used in conjunction with a single-lumen tube, an endotracheal tube, a double-lumen tube (e.g., a Broncho-Cath™ tube), a specialty tube, or any other airway device with a main ventilation lumen. Indeed, any device with a ventilation lumen designed for use in an airway of a patient may include an outer cannula with a tapered distal end portion as provided. As used herein, the term “tracheal tube” may include an endotracheal tube, a tracheostomy tube, a double-lumen tube, a bronchoblocking tube, a specialty tube, or any other airway device. Further, while the disclosed embodiments are shown with two cannulas (e.g., an inner cannula and an outer cannula), it should be understood that any of the disclosed embodiments may be used in conjunction with a single cannula.
Turning now to the drawings,
The outer cannula 12 is illustrated extending both distally as well as proximally from a flange member 20. A pair of side wings of the flange 20 extend laterally and serve to allow a strap or retaining member (not shown) to hold the tube assembly 10 in place on the patient. In one embodiment, apertures formed in each side of the flange member 20 allow the passage of such a retaining device. In many applications, the flange member 20 may be taped or sutured in place as well. In some embodiments, a proximal portion of the outer cannula 12 that is outside of the patient may form an outer cannula connector 22. The outer cannula connector 22 may receive an end region of an inner cannula and form a secure connection with the inner cannula. During intubation, the tracheal tube assembly 10 is placed through an opening formed in the neck and trachea of a patient and extending into the patient airway. In certain embodiments, the tracheal tube assembly 10 is curved to accommodate the curved tracheal passageway. For example, the outer cannula 12 may be curved in an unbiased state (i.e., outside the patient) such that an inner curve 24 is generally positioned on a ventral side of the patient while the outer curve 26 is positioned on the dorsal side of the patient when the tracheal tube assembly 10 is inserted in the patient. Further, the outer cannula 12 may include a tapered and/or curved distal tip 27 to facilitate insertion into the patient. As provided herein, the tapered distal tip 27 of the outer cannula 12 may be formed using a melt mold.
The melt mold 28 may include a first portion 32 that may surround (e.g., fit about or mate with) the distal end 30 of the outer cannula 12 and a second portion 34 that may extend past the distal end 30 of the outer cannula 12 when the distal end 30 is inserted into the melt mold 28. In some embodiments, the first portion 32 of the melt mold 28 may be curved in an unbiased state (i.e., outside of the patient) similar to the outer cannula 12 to facilitate the insertion. In particular, similar to the outer cannula 12, the melt mold 28 may include an inner curve 36 and an outer curve 38 that are configured to align with (e.g., have the same degree of curvature as) the inner curve 24 and the outer curve 26 of the outer cannula, respectively. In certain embodiments, the curves 36 and 38 are present in the cavity formed by the first portion 32 and the second portion 34 and may or may not extend to the outer wall 39 of the melt mold 28. In this manner, the first portion 32 may follow the same curve (e.g., same alignment, complimentary curves) as the distal end 30 of the outer cannula 12. Accordingly, the insertion of the outer cannula 12 into the melt mold 28 may be directional such that proper insertion involves the inner curve 24 of the outer cannula 12 located proximate to or corresponding with the inner curve 36 of the melt mold 28. Similarly, the outer curve 26 of the outer cannula 12 may be located proximate to the outer curve 38 of the melt mold 28. Further, in embodiments in which the outer cannula 12 is tapered, for example having a smaller diameter at the distal end 30 than the proximal end, the first portion 32 of the melt mold 28 may include a complimentary taper.
The melt mold 28 may also include portions to facilitate the melting process. As illustrated, the melt mold 28 includes a collar portion 40 that may project radially outward from the melt mold 28. The collar portion 40 may be clamped to secure the melt mold 28 when heat is applied to the melt mold 28 and to the inserted distal end 30 of the outer cannula 12. In some embodiments, the melt mold 28 may also include a transition portion 42 disposed between the collar portion 40 and the first portion 32. As will be discussed in more detail below, the transition portion 42 may include a diameter that is larger than a diameter of the first portion 32 to facilitate the insertion of the distal end 30 of the outer cannula 12 into the melt mold 28.
As noted above, the melt mold 28 includes the second portion 34 that extends past the distal end 30 of the outer cannula 12 when the distal end 30 is inserted into the second portion 34. In some embodiments, the second portion 34 may be curved to align with the curve of the first portion 30 and/or the distal end 30 of the outer cannula. Additionally or alternatively, the second portion 34 may be tapered. For example, as illustrated, the second portion 34 may be tapered such that an outer diameter of a distal end 44 of the second portion 34 is less than an outer diameter of a proximal end 46 of the second portion 34. In some embodiments, the second portion 34 may be gradually tapered. In other embodiments, the second portion 34 may include a stepped taper. Additionally, as will be described in more detail below, the degree (e.g., angle) of taper of the second portion 34 may vary about the circumference of the second portion 34. For example, in some embodiments, an outer curve 48 of the second portion 34 may have greater a degree of taper than an inner curve 50. However, in other embodiments, the degree of taper of the inner curve 50 of the second portion 34 may be approximately equal to or less than the degree of taper of the outer curve 48 of the second portion 34.
The melt mold 28 may include one or more features to facilitate the placement of the distal end 30 of the outer cannula 12 at a distance 62 from the distal end 44 of the melt mold 28. Further, in some embodiments, the melt mold 28 may include an indent 64 that is formed by the distal end 44 and extends into the interior cavity 61 to define an interior surface 65 of the interior cavity 61. The indent 64 may be configured to be at least partially disposed within the outer cannula 12 (e.g., the distal end 30) when the outer cannula 12 is inserted in the interior cavity 61 of the melt mold 28. The indent 64 may define a generally cylindrical or barrel-shaped opening placed within the interior of the outer cannula 12. In some embodiments, an outer diameter 66 of the indent 64 may increase toward the distal end 44 of the melt mold 28 such that a space 68 (e.g., a gap) between an exterior wall 70 of the melt mold 28 and the interior surface 65 decreases toward the distal end 44 of the melt mold 28. In particular, the space 68 in the first portion 32 of the interior cavity 61 may have a width that is configured to permit insertion of the outer cannula 12 into the interior cavity, while the space 68 in the second portion 34 of the interior cavity 61 may be narrower than the width of the wall of the outer cannula 12 to prevent advancement of the outer cannula 12 into the second portion 34. Additionally, as noted above, the second portion 34 of the melt mold 28 may taper (e.g., narrow) toward the distal end 44 of the melt mold 28, which may also decrease the space 68 between the exterior wall 70 and the interior surface 61. The decreased width of the space 68 may facilitate the positioning of the outer cannula 12 at the distance 62 from the distal end 44 of the melt mold 28. As will be described in more detail below, positioning the outer cannula 12 at the distance 62 from the distal end 44 of the melt mold 28 may be desirable during the melting processing to enable the inserted distal end 30 of the outer cannula 12 to melt into the space 68 in the second portion 34 to form the tapered distal tip 27.
In addition to facilitating the desired placement of the outer cannula 12 into the melt mold 28, the indent 64 may also function to stabilize the melt mold 28 on the outer cannula 12 during a heating (e.g., melting) process. In particular, a height 72 of the indent 64 may be correlated with the stability. For example, a greater height 72 may yield a more secure fit between the melt mold 28 and the outer cannula 12 when the outer cannula 12 is inserted into the melt mold 28. In some embodiments, the height 72 of the indent 64 may be between approximately 20 percent and 100 percent, 30 percent and 90 percent, 40 percent and 80 percent, or 50 percent and 70 percent of a height 74 of the melt mold 28. In one embodiment, the height 72 of the indent 64 may be approximately two-thirds of the height 74 of the melt mold 28. For example, in some embodiments, the height 74 of the melt mold 28 may be between approximately 5 millimeters (mm) and 30 mm, 10 mm and 25 mm, or 15 mm and 20 mm. In one embodiment, the height 74 may be approximately 17 mm. Additionally, the height 72 of the indent 64 may be between approximately 5 mm and 25 mm, 8 mm and 20 mm, or 10 mm and 15 mm. In some embodiments, the height 72 of the indent 64 may be between approximately 10 mm and 12 mm.
The outer cannula 12 may have dimensions selected to fit easily through the stoma. In practice, a range of such tubes may be provided to accommodate the different contours and sizes of patients and patient airways. Such tube families may include tubes designed for neonatal and pediatric patients as well as for adults. By way of example only, the outer cannula 12 of the tube 10 may range from 4 mm to 16 mm. Accordingly, the melt mold 28 may be sized to correspond with an appropriate outer cannula 12 to facilitate the insertion of the outer cannula 12 within the melt mold 28.
Because the outer cannula 12 fits within the melt mold 28, at least a portion of the melt mold 28 features a larger inner diameter 76 relative to an outer diameter 78 of an inserted portion 80 of the outer cannula 12. As noted above, the melt mold 28 may be sized to correspond with the outer cannula 12. Accordingly, the inner diameter 76 may be selected based upon the size of the outer cannula 12. In certain embodiments, the inner diameter 76 may range from 5 mm to 20 mm.
Additionally, in embodiments in which the melt mold 28 includes the indent 64, the outer diameter 66 of the indent 64 may be less than an inner diameter 82 of the inserted portion 80 of the outer cannula 12 to facilitate the insertion of the outer cannula 12 between the outer wall 70 and the indent 64. Further, the space 68 between the outer wall 70 and the indent 64 in the first portion 32 of the melt mold 28 may be sized to correspond with the thickness of the walls of the outer cannula 12. For example, the walls of the inserted portion 80 of the outer cannula 12 may be about 1 millimeter (mm) thick. Accordingly, the space 68 in the first portion 32 of the melt mold 28 may be between about 1 mm to about 1.5 mm wide. Thus, an outer diameter 84 of the first portion 32 of the melt mold 28 may be at least 1 mm to 1.5 mm greater than the outer diameter 78 of the outer cannula 12.
The indent 64 may also define an exterior cavity 86 of the melt mold 28. The exterior cavity 86 may facilitate the melting process. In particular, heat may be applied to the exterior cavity 86, in addition to the exterior 70 of the melt mold 28, to facilitate the melting of the inserted portion 80 of the outer cannula 12 into the space 68 at the distal end 44 of the melt mold 28. Applying heat to the exterior cavity 86 may be desirable to decrease the time to melt the inserted portion 80. Melting the inserted portion 80 of the outer cannula 12 to form the tapered distal tip 27 may seal a lumen 88 (e.g., an inflation lumen to provide a gas to inflate the cuff 16) of the outer cannula 12. Thus, gases from the lumen 88 may be sealed off at the tapered distal tip 27 of the outer cannula 12.
As noted above, the first portion 32 of the melt mold 28 may be tapered to facilitate the insertion of the distal end 30 of the outer cannula 12 into the melt mold 28. Further, as illustrated in
Further, as noted above, the taper of the second portion 34 may vary about the circumference (e.g., about a rotational axis) of the second portion. In some embodiments, the degree (e.g., angle) of taper of an outer wall 112 of the second portion 34 may vary about the circumference of the outer wall 112 of the second portion 34. In some embodiments, the degree of taper of the outer wall 112 may continuously vary about the circumference of the outer wall 112. In particular, the outer curve 48 of the second portion 34, which may correspond to the outer curve 26 of the outer cannula 12, may have a first angle of taper 114. The inner curve 50, which may correspond to the inner curve 24 of the outer cannula 12, may have a second angle of taper 116. As illustrated, the first angle of taper 114 may be less than the second angle of taper 116. For example, the first angle of taper 114 may be between approximately 10 percent to 95 percent, 30 percent to 90 percent, 50 percent to 85 percent, or 70 percent to 80 percent of the second angle of taper 116. Alternatively, the first angle of taper 114 may be greater than the second angle of taper 116. Furthermore, in certain embodiments, the length of the outer curve 48 may be greater than the length of the inner curve 50. For example, the length of the inner curve 50 may be between approximately 10 to 100 percent, 50 to 95 percent, or 80 to 90 percent of the length of the outer curve 48.
Additionally, as illustrated in
Furthermore, at least a portion of the exterior cavity 86 of the indent 64 of the melt mold 28 may be tapered. In particular, as illustrated in
As shown in
An outer diameter 130 of the inner cannula 128 may be selected to allow sufficient air flow while also fitting comfortably within the outer cannula 12 and allowing for appropriate insertion force. An inner diameter 132 of the inner cannula 128 may be less than the outer diameter 130 by the thickness of the walls of the inner cannula 128. For example, an inner cannula 128 sized to 6.5 mm may have an outer diameter 130 of about 6.5 mm and an inner diameter 132 of about 5.5 mm. In such an embodiment, the inner cannula walls are about 1 mm thick in the inserted portion of the inner cannula 128 (e.g., in portions distal of the outer cannula connector 22). Similarly, a 10 mm inner cannula 128 may have an inner diameter of about 9 mm. Accordingly, tubes sized to 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm, 9.0 mm, or 10 mm may feature smaller inner diameters that define the airflow passage.
Further, an inner diameter 134 of the outer cannula 12 may be selected to allow for the inner cannula 128 to be easily inserted into the outer cannula 12. In particular, the inner diameter 134 of the outer cannula 12 may be slightly larger than the outer diameter 130 of the inner cannula 128 to facilitate the insertion of the inner cannula 128 into the outer cannula 12. For example, the inner diameter 134 of the outer cannula 12 may be larger than the outer diameter 130 of the inner cannula 128 by approximately 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, or any other suitable distance. However, the difference in the inner diameter 134 of the outer cannula 12 and the outer diameter 130 of the inner cannula 128 may result in a gap 136 between the outer cannula 12 and the inner cannula 128 when the inner cannula 128 is inserted into the outer cannula 12. However, secretions (e.g., mucus) may accumulate inside of the gap 136, which may increase the patient's work of breathing. Furthermore, the secretions may cause the inner cannula 128 to become stuck to (e.g., adhere to) the outer cannula 12, which may cause a caregiver to apply a greater force to remove the inner cannula 128 from the outer cannula 12 (e.g., for cleaning or replacement). Additionally, the gap 136 may be undesirable because air that passes through the gap 136 may increase loss of air during ventilation, which may lead to inadequate ventilation of the patient. Additionally, the gap 136 may result in a whistling noise as the patient breathes, which may adversely affect the clarity of the patient's speech.
To mitigate the occurrence and/or severity of issues that may result from the gap 136, such as those described above, the tracheal tube assembly 10 may include features to facilitate that may seal the gap 136 between the inner cannula 128 and the outer cannula 12. For example, the tracheal tube assembly 10 may include one or more inflation devices 138. The one or more inflation devices 138 may include an inflatable bladder (e.g., a balloon), which may be configured to be inflated by any suitable inflation medium, such as a gas (e.g., air, nitrogen, or any other suitable gas) or a liquid. In particular, the system 10 may include an inflation system (not shown) configured to deliver the inflation medium to the one or more inflation devices 138. In certain embodiments, the inflation system may deliver the inflation medium to the inflation devices 138 via a lumen 140 of the inner cannula 128. Additionally or alternatively, the inflation system may deliver the inflation medium to the inflation devices 138 via a lumen of the outer cannula 12. In one embodiment, the inflation system may be coupled to a wall of the inner cannula 128 and/or a wall of the outer cannula 12. The inflation system may be configured to deliver an amount of the inflation medium suitable to cause the inflation devices 138 to seal (e.g., fill or block) the gap 136 between the inner cannula 128 and the outer cannula 12.
The inflation devices 138 may be formed in any suitable shape. For example, the inflation devices 138 may be spherical, tapered, barrel-shaped, rectangular, or the like. Additionally, each inflation device 138 may include a single inflatable bladder (e.g., balloon) or may include more than one inflatable bladder. The inflation devices 138 may be manufactured from any suitable polymer material with low to high wall thickness. By way of example, the inflation devices 138 may be formed from polyethylene teraphthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polysioprene, polyurethane, or any combination thereof.
The inflation devices 138 may be disposed in the gap 136 in any location along the length of the tracheal tube assembly 10. The inflation devices 138 may be coupled in or on a wall of the inner cannula 128 or a wall of the outer cannula 12. In some embodiments, the inflation devices 138 may be secured to the inner cannula 128 or the outer cannula 12 via an adhesive. Further, the tracheal tube assembly 10 may include one inflation device 138 at a particular location along the length of the tracheal tube assembly 10 (e.g., at distance 144), or may include two or more inflation devices 138 at the same position (e.g., the distance 144) that are disposed about the circumference of the inner cannula 128. Furthermore, in one embodiment, the inflation device 138 may form a ring and may be disposed around the circumference of the inner cannula 128. Additionally, the tracheal tube assembly 10 may include any suitable number of inflation devices 138.
With the foregoing in mind, methods of manufacturing the embodiments of the tracheal tube assembly 10, as described above with respect to
The method 150 may also include cutting the outer cannula 12 (block 154) to a desired length. In one embodiment, the outer cannula 12 may be cut to a length of approximately 15 mm. The method 150 may also include shaping the outer cannula 12 (block 156). As noted above, it may be desirable for the outer cannula 12 to be curved in an unbiased state (i.e., outside the patient) such that the inner curve 24 is generally positioned on a ventral side of the patient while the outer curve 26 is positioned on the dorsal side of the patient when the tracheal tube assembly 10 is inserted in the patient. Accordingly, the outer cannula 12 may be shaped (e.g., bent or angled) into the desired curvature. For example, the outer cannula 12 may be placed on a mandrel having the desired curvature, and the outer cannula 12 may be heated (e.g., baked) to a temperature sufficient to set the curvature. In one embodiment, the outer cannula 12 may be heated for approximately seven minutes. After heating the outer cannula 12, the outer cannula 12 may be chilled, which may also facilitate setting the curvature of the outer cannula 12. In one embodiment, the outer cannula 12 may be chilled for approximately ten minutes.
The method 150 may include cutting the outer cannula 12 (block 158) to a second desired length. In certain embodiments, the second desired length of the outer cannula 12 may be based upon the extruded diameter of the outer cannula 12. Additionally, in some embodiments, the distal end 30 of the outer cannula 12 may be cut on an angle to create a beveled distal end.
Further, the method 150 may include providing a curved and/or tapered melt mold (e.g., the melt mold 28) (block 160). The melt mold 28 may be formed using any suitable material or combination of materials, such as, for example, stainless steel, iron, polyethylene (e.g., low density polyethylene), polypropylene, PTFE, expandable PTFE, polyvinyl chloride (PVC), PEBAX silicone, polyurethane, thermoplastic elastomers, polycarbonate plastic, silicon, or acrylonitrile butadiene styrene (ABS). In certain embodiments, the melt mold 28 may be manufactured using a material having a high melting point (e.g., higher than the melting point of the outer cannula 12). Furthermore, the melt mold 28 may be manufactured using any suitable technique. For example, the melt mold 28 may be molded, overmolded, two shot molded, computer numerical control (CNC) machined, milled, or otherwise formed into the desired shape, as described above with respect to
In some embodiments, the melt mold 28 may be disposed within, integrated within, or otherwise secured to a melt mold manufacturing apparatus. As used herein, a melt mold manufacturing apparatus may be any suitable device configured to apply heat to the melt mold 28 and/or the outer cannula 12 to melt a portion of the outer cannula 12 into the melt mold 28. In one embodiment, the melt mold 28 may be disposed within (e.g., embedded into) a platform of a melt mold manufacturing apparatus. Further, the platform may be coupled to a source of heat that may be configured to deliver heat to the melt mold 28 and/or the outer cannula 12 when the outer cannula 12 is inserted into the melt mold 28.
The method 150 may also include melting a portion of the outer cannula 12 into the melt mold 28 to form the tapered distal tip 27 (block 162). For example, the outer cannula 12 may be placed on a curved pin or mandrel and the melt mold 28 may be positioned about the distal end 30 of the outer cannula 12. In other embodiments, the outer cannula 12 may be placed on a curved pin or mandrel that may be configured to insert the outer cannula 12 into the melt mold 28. For example, the curved pin or mandrel may be secured to a movable platform of the melt mold manufacturing apparatus that is configured to move and/or rotate the curved pin or mandrel such that the curved pin or mandrel and the outer cannula 12, if placed on the curved pin or mandrel, is inserted into the melt mold 28.
As noted above, melt mold 28 may be directionally shaped such that the outer cannula 12 may enter the melt mold 28 in only one direction or orientation. At least a portion of the inserted portion 80 of the outer cannula 12 may be melted into the melt mold 28. For example, heat may be applied to the exterior of the melt mold 28 and/or the exterior cavity 86 of the indent 64 of the melt mold 28 when the inserted portion 80 is inserted in the melt mold 28 to melt the inserted portion 80 of the outer cannula 12. In some embodiments, pressurized gas may be applied to the melt mold 28 and/or the outer cannula 12 to facilitate the expansion of the melted portion of the outer cannula 12 into the melt mold 28. The melted inserted portion 80 of the outer cannula 12 may be cooled (e.g., chilled) inside of the melt mold 28. The outer cannula 12 may be removed from the melt mold 28, or vice versa, after cooling. As noted above, melting the inserted portion 80 of the outer cannula 12 may cause the inserted portion 80 of the outer cannula 12 to take the shape of the interior cavity 61 of the melt mold 28. Thus, the inserted portion 80 of the outer cannula 12 may be formed into the tapered distal tip 27. This may provide a tracheal tube assembly 10 that is more comfortable for the patient than tracheal tubes having straight tips (e.g., not curved) with straight, blunt ends. Further, providing the tapered distal tip 27 that is continuous with the outer cannula 12 may facilitate the insertion and positioning of the tracheal tube assembly 10 into the patient.
It is envisioned that the tracheal tube assembly 10 as provided herein may be provided as an assembly and/or as a kit. A kit may include a packaging that encloses an inner cannula 128 sized for an outer cannula 12, which may include the tapered distal tip 27 manufactured using the melt mold 28, an affixed outer cannula connector 22 and flange member 20. The kit may also include a neck strap for retaining the tracheal tube 10 in place. The kit may also include an obturator 190, shown in
While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Indeed, the disclosed embodiments may not only be applied to airway devices, but these techniques may also be utilized for connections between inner and outer conduits for other types of medical devices and medical connective tubing. Rather, the various embodiments may cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims.
This application claims the benefit of U.S. Provisional Application No. 61/898,969 filed Nov. 1, 2013, which is hereby incorporated by reference in its entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 61898969 | Nov 2013 | US |
