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214 2 4 2 13 TRACHEOSTOMY TUBE OBTURATOR AND ASSEMBLY The present invention relates to tracheostomy tube obturators and assemblies.
The obturator of the present invention is particularly designed for use with a tracheostomy tube which includes a non-constant radius cannula as a part of its configuration.
Tracheostomy tubes are widely used to supply air to the lungs of unconscious patients such as injured persons and patients undergoing surgery.
In order for the tracheostomy tube to function as intended it must be properly applied to the trachea so that air can be directed through the tube and into the trachea. However, proper insertion of the tube represents a very difficult task and it is possible during the insertion procedure to miss the surgically prepared opening in the trachea and misguide the tracheostomy tube device into the surrounding tissue. Failure to properly insert the tracheal tube can cause serious problems and incur dangerous consequences for the patient.
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"k-, Otolaryngologists, Thoracic Surgeons, General Surgeons and other clinical professionals may experience difficulties in performing intubuation procedures. To assist the physician, a variety of guides such as stylets or obturators are available to clinicians to guide and to assist the placement of such tube in the patient's trachea.
Obturators are used to guide metal or polymeric tracheostomy tubes such as described, for example, in U.S. Patents 3,088,466 and 3,659,612 to Shiley et al. The characteristic common feature of these tubes is a constant radius design of the cannula portion. A constant radius cannula is defined herein a cannula having a continuous curvature between its proximal and distal ends.
It is important in the intubation procedure that the obturator not only be easily insertable into the cannula, but also easily and safely removable after the intubation has been completed.
The removal of the obturator used with tracheostomy tubes having constant radius cannula does not present significant problems as the obturator can be easily pulled along the radius of curvature for easy frictionless removal.
However, many flexible tracheostomy tubes used nowadays are -designed to include a non-constant radius cannula. Typically such a tracheostomy tube has at least two substantially straight cannula sections and a curved section located therebetween. The arc of the curve may be designed as forming a right angle or approaching a right angle. The straight sections may be of considerable length. The withdrawal of the obturator from the non-constant radius cannula presents a more difficult task.
U.S. Patent 4,471,776 to Cox describes an example of a tracheostomy tube including an obturator with an adjustable shape. This obturator includes a malleable shaft which allows for the obturator placed inside the tube to be bent together with the tube to a desired curved configuration. However, it is difficult to remove the obturator from the tracheostomy tube since the forces which maintain the curved geometry of the tube and the obturator have to be overcome.
other types of flexible guiding devices available on the market 'are socalled 1'steerablell wire guide devices which bend to a selected fixed constant curvature. Such guiding stylets inserted into the catheter/cannula are designed to impact the curvature to the catheter/cannula. The wire-type guiding devices are most commonly employed with medical 1 X.
devices having an extremely long length as compared to their diameter which is usually very small. The spring-like functions of such small diameter guidewires would be difficult to overcome when such mechanisms are applied to the typical geometry of a tracheostomy or endotracheal tube.
For accomplishing a proper intubation, it is very important that the cannula maintains its shape and does not become occluded or distorted, such that an airway passway is maintained clear through th;a intubated cannula during and after the intubation procedure.
There is a significant need in the art for an obturator suitable for use with tracheastomy tubes, particularly those including a non-constant radius cannula, which would eliminate disadvantages of the prior art. There does not exist a highly flexible, plastic, single-piece, easily insertable and safely removable suitable for tracheostomy tube5.-having cannula.
guiding device especially non-constant radius There is a need for an obturator which would substantially prevent tracheostomy tube occlusion or collapse during the intubation and additional distortion of-the device once the tube is in place in the trachea, increasing the patient's safety and comfort.
W 1 It is the primary object of the present invention to provide an improved device which assists in guiding a tracheostomy tube towards the incision made in the trachea in order ta-facilitate proper insertion of the tube.
Another object of the preent invention is to provide an obturator which is especially suitable for use with tracheostomy tubes which include a non-constant radius cannula.
A further object of the present invention is to provide an obturator which can be easily inserted andlsafely removed through straight and curved portions of the non-constant radius cannula.
Another object of the present invention is to provide an obturator which is highly flexible, but able to maintain the geometry of the cannula during the intubation procedure to prevent occlusion, collapse and distortion of the cannula, and to ensure an internal non-disturbed airway.
Still another object of the present invention is to provide an obturator which is highly flexible and will easily assume the preferred contour of the tracheostomy tube, and will maintain the internal geometry of the cannula during intubation.
Another object of the present invention is to provide a multi-component highly flexible obturator made as an integral, single piece member thereby eliminating possible failure of assembly points and enhancing safety of the device.
Still another object of the present invention is to provide a plastic obturator which has a simple structure and is inexpensive to manufacture.
According to one aspect of the present invention there is provided obturator means;Eor use with a tracheostomy tube of the kind having a nonconstant radius of curvature, the obturator means being insertable into the tracheostomy tube for guiding intubation of the tracheostomy tube into the patient's trachea, and the obturator means comprising a flexible member having a plurality of segments and a plurality of hinge members located between the segments; grasping means located at the proximal end,, ,and a tapered tip member located at the distal end.
The flexible member is preferably of a substantially flat strip member with a.plurality of segments extending substantially perpendicularly of the strip member. The segments are preferably dimensioned such as substantially to correspond to the inner diameter of the tracheostomy tube. The segments may have a bead-like configuration or be in the form of circular discs. The obturator means is preferably a single-piece construction and may be of a polymeric material. The tip member may be of substantially conical shape.
According to another aspect of the present invention there is provided a tracheostomy tube assembly comprising a tracheostomy tube and obturator means according to the above one aspect of the present invention.
The present invention due to its structure and nature of the material, flexes easily at the hinged portions in the axis of the curved tube portion when it is being inserted or removed from the tracheostomy tube without applying forces which can cause change in the cannula's shape. At the same time, when placed within the tube, the obturator substantially fills, with the plurality of segments, the interior of the cannula whereby maintaining geometry of the tube during the intubuation. This,' in turn, prevents occlusion or collapse of the tube during intubation and any distortion of the tube once in place in the patient's trachea, and ensures a non-distubed 1 airway through the tracheostomy tube device.
The structure of the present invention obturator is substantially resistant to compression forces, which typically In malleable wire-type stylet obturators or strap-like plastic current state of the art devices, because they do not fill the cannula completely, allow the obturator tip to push back and complicate the intubating procedure due to the lack of a smooth transition from the obturator tip to the tracheostomy tube outside diameter. The smooth transition is therefore secured between the tip member of the obturator and the outer diameter of the tracheostomy tube device in the present invention structure.
The single-piece obturator structure also increases the reliability of the tracheostomy tube assembly by eliminating additional possible failure points common to all devices of multicomponent configuration, an enhanced safety feature for both the clinician and the patient during intubation procedure.
1 Additional key features of the preferred embodimenp of the present invention,include a multi-geometry highly flexible single piece structure and polymeric material construction, resulting in a device that provides easier, more efficient and safer use during the intubation procedure increasing patient safety and comfort.
A tracheostomy tube assembly including an obturator, in accordance with the present invention, will now be described, by way of example, with reference to the accompanying drawings, in which:
Figure 1 shows a perspective view of one form of obturator; Figure 2 shows a side view of the obturator of Figure 1; Figure 3 shows a cross- section of the obturator taken along line 3 3' in Figure 2; Figure 4 shows a cross-section view of the tracheostomy tube assembly, the obturator in place inside the tube; Figure 5 shows a perspective view of an alternative obturator; and Figure 6 shows a cross-section view of the obturator of Figure 5.
Referring first to Figures 1 and 2, an obturator 10 is shown, which includes a single-plece member having a distal end 11, proximal end 12 and a shaft means 13 extending between the distal and proximal end 11, 12. The shaft means 13 is comprised of a substantially flat member 19 and a plurality of segments 14 disposed substantially perpendicular to the flat strip member member 19. This flat strip member 19 forms a plurality of hinged portions 15 alternating with the segments 14. In the preferred embodiment shown in Figures 1-4, the segments 14 are bead-like shaped. The obturator 10 includes a grasping means 17 formed at its proximal end 12, and a tip member 16 provided at its distal end 11. In the preferred embodiment, the obturator 10 is made as an integral, plastic, singlepiece device.
Figure 4 shows a tracheostomy tube assembly having a tracheostomy tube 100 including a non-constant radius curved cannula 20 having straight portions 32 and 34 and a curved portion 36 located therebetween. The cannula 20 includes a proximal end 24 and a distal end 22. A connector 26 is connected to the proximal end 24 of the straight portion 32. In Figure 4, the obturator 10 for use in intubating the tracheostomy tube 100 into the patient's trachea is shown in place within the tracheostomy tube 100.
1 As clearly shown in Figure 4, the obturator shaft means 13 flexes at the hinged portions 15 in the axis of the curved cannula portion 36. The grasping means 17 forming In the preferred embodiment, a handle projects beyond the end 30 of the connector 26. The tip member 16 of the obturator 10 projects beyond the end 22 of the cannula 20. The tip member 12 - 16 has a bullet-like conical shape which facilitates the guiding of the tracheostomy tube during the intubating procedure. As is clearly apparent from Pigs. 3 and 4, the diameters of the plurality of segments 14', substantially corresponds to the inner diameter of the cannula 20. Therefore, when placed within the tube, the obturator substantially spans the interior of the cannula 20 which allows it to maintain the shape of the tube during the intubation.
Such a structure of the obturator is very advantageous, since it substantially prevents occlusion or collapse and distortion of the tracheostomy tube, and ensures the existence of a non-disturbed airway.
Figures 5 and 6 show another embodiment of the present invention in which the shaft 13 is comprised of a plurality of substantially flat disc-like circular segments 40 which are substantially perpendicular to the_hinged portions 15 of the strip member 19.. The diameter of circular segments 40 also substantially corresponds to the inner diameter at the cannula-20.
Other shapes for a plurality of segments can be envisioned, for example, having a trapezoidal configuration.
1 13 - According to the preferred embodiment, the obturator.10 is made of a polymeric material, such as for example polyolefins. However, other plastic materials can be used which are suitable for c:i multi-hinged geometry.
Due to the multi-hinged structure and the nature of the plastic material, the obturator 10 easily flexes only in the radial direction of the cannula 20 in the axis of the curved tube portion 36, whereby it is easily insertable and removable from the tracheostomy tube 100. These features of the present invention are particularly important and advantageous during the withdrawal of the obturator from the non-constant radius cannula, because the forces necessary for the withdrawal of the obturator from the cannula are substantially decreased.
Also the structure'of the present invention obturator with the shaft means including a substantially flat strip member forming hinged portions and a plurality of segments perpendicular to the strip member and alternating with hinged portions, is substantially resistant to compression forces, which typically in malleable wire-type stylets/obturators, allow the obturator tip member to push back towards the inside of the cannula. This, in turn, complicates the intubating procedure due to the lack of a smooth transition between the obturator tip and tracheostomy tube outside diameter.
In the present invenion obturator structure, the smooth transition is provided between the tip 16 and the outer diameter of the tracheostomy tube. The multi-component obturator 10 of the present invention is made as an integral singlepiece, plastic device. The number of bead-like or circular disc-like segments and hinge portions is selected with respect to the length of the tracheostomy tube and the position of the curved section.
The hinge-like structure allows the obturator to be highly flexible in the axis of the tube curved section. The plurality of segments of the obturator substantially fill up the tube's interior maintaining the integrity of the tracheostomy tube, but at the same time allowing easy flexing during insertion or removal of the obturator from the tracheostomy tube. The obturator's tip is designed with a straight section which absorbs----the deflection of the tube and obturator size tolerance without compromising the streamline tip,profile. The handle projecting beyond the connector faclitates the withdrawal of the obturator from the tracheostomy tube.
-1 1 It will be understood that variations and modifications may he effected without departing from the spirit and scope of the novel concepts of the present invpntion.
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