Hinged tracheostomy tube obturator

In combination, a tracheostomy tube including a curved cannula lying substantially within a given plane and formed with a non-constant radius, and an obturator means insertable into the cannula for guiding intubation of the tracheostomy tube into the cannula. The obturator comprises a single piece member formed of a resilient and flexible material and curvable upon insertion within the cannula with a non-constant radius lying within the given plane, the member having proximal and distal ends and a shaft extending therebetween, the shaft over a substantial portion of its length being dimensioned such as to impart sufficient rigidity both in the direction substantially perpendicular and also substantially parallel to the given plane. The shaft also includes a first flexible portion being of substantially rectangular cross-section having a width and a thickness, the width as measured perpendicular to the given plane substantially exceeding its thickness. The shaft at the flexible portion is easily flexible along its length in the given plane of its curvature but is substantially stiff in a direction perpendicular to the given plane because of the greater width of its cross-section.

FIELD OF THE INVENTION 
The present invention relates to tracheostomy tube devices and more 
particularly to an improvement in guiding devices such as obturators that 
are used to assist in the insertion of a tracheostomy tube into a 
patient's trachea. 
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. 
BACKGROUND OF THE INVENTION 
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. Otolaryngologists, Thoracic 
Surgeons, General Surgeons and other clinical professionals may experience 
difficulties in performing intubation 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 tubes in the 
patient's trachea. 
The obturators are used to guide metal or polymeric tracheostomy tubes such 
as described, for example, in U.S. Pat. Nos. 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 as a cannula having a continuous curvature between its 
proximal and distal ends. 
It is important in the intubation procedure that the obturator be not only 
easily insertable into the cannula, but also easily and safely removable 
after the intubating 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. Pat. No. 4,471,776 to Cox describes an example of a tracheostomy tube 
including an obturator with an adjustable shape. This obturator includes a 
mealable 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 
so-called "steerable" 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 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 the intubated 
cannula during and after the intubation procedure. 
There is a significant need in the art for an obturator suitable for use 
with tracheostomy 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 guiding device especially suitable for 
tracheostomy tubes having non-constant radius cannula. 
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. 
SUMMARY OF THE INVENTION 
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 to facilitate proper insertion of the tube. 
Another object of the present 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 and safely 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. 
The above and other objects of the present invention are accomplished by a 
structure of the obturator for use in intubating tracheostomy tubes into a 
patient's trachea which includes a single-piece, flexible member having a 
distal end and a proximal end and a shaft means extending therebetween. 
The shaft means is comprised of a substantially flat strip member and a 
plurality of segments substantially perpendicular to the flat strip 
member. The flat strip forms a plurality of hinged portions alternating 
with the plurality of segments. The flexible member has a grasping means 
formed at its proximal end and a tip member provided at its distal end. 
The tip member has a bullet-like conical shape. A smooth transition zone 
is formed between the tip member and the outer diameter of the 
tracheostomy tube. 
In the preferred embodiment of the present invention, the single-piece, 
flexible obturator is made of polymeric material and the plurality of 
segments (protuberances) are dimensioned such as to substantially 
correspond to the inner diameter of the cannula. 
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 changes 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 intubation. 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-disturbed airway through the tracheostomy tube device. 
The structure of the present invention obturator is substantially resistant 
to compression forces, which typically in mealable 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 the 
diameter. The smooth transition is therefore secured between the tip 
member of the obturator and the outer diameter of the tracheostomy tube 
device to 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. 
Additional key features of the preferred embodiment 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. 
In another preferred embodiment of the present invention means are provided 
in the structure of the flexible obturator which prevent the tip of the 
obturator from being pushed up inside the tracheostomy tube, while the 
physician is placing the tube into the patient. 
Other advantages achievable by the present invention will become apparent 
from the following description of the preferred embodiment of the present 
invention with reference being made to the accompanying drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S) 
Referring first to FIGS. 1 and 2, an obturator 10 is shown, which includes 
a single-piece member having a distal end 11, proximal end 12 and a shaft 
means 13 extending between the distal and proximal ends 11,12. The shaft 
means 13 is comprised of a substantially flat member 19 having a 
rectangular cross-section and having a plurality of segments or 
protuberances 14 disposed substantially perpendicular to the flat strip 
member 19. The rectangular cross-section of the shaft means has a width 
and a thickness with the width substantially exceeding its thickness. This 
flat strip member 19 forms a plurality of hinged portions (or spaces) 15 
alternating with the segments 14. In the preferred embodiment shown in 
FIGS. 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, single-piece device. 
FIG. 4 shows tracheostomy tube 100 including a non-constant radius curved 
cannula 20 lying substantially within a given plane and having straight 
portions 32 and 34 and 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 FIG. 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. 
As clearly shown in FIG. 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 16 has a 
bullet-like conical shape which facilitates the guiding of the 
tracheostomy tube during the intubating procedure. As is clearly apparent 
from FIGS. 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. 
FIGS. 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 of the cannula 20. 
Other shapes for a plurality of segments can be envisioned, for example, 
having a trapezoidal configuration. 
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 a 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 mealable 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 invention 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 single-piece, 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 facilitates the withdrawal of the obturator from the 
tracheostomy tube. 
FIGS. 7 to 10 show still another embodiment of the present invention 
obturator While the embodiments shown in FIGS. 1-6 can be especially 
advantageously used with, for example, flexible pediatric tracheostomy 
tubes, the obturator shown in FIGS. 7 to 10 is particularly adapted for 
use with adult rigid tracheostomy tubes having a curved cannula lying 
substantially within a given plane and having a non-constant radius. 
As shown in FIGS. 7 to 10, this embodiment also includes a single-piece 
member 10 made of flexible material, preferably plastic, which includes a 
tip member 16 at the distal end 11 and grasping means 17, forming a handle 
at the proximal end 12. Shaft means 13 extends between the proximal and 
distal ends 11,12. The shaft means 13 over a substantial portion of its 
length is dimensioned such as to impart sufficient rigidity both in the 
direction substantially perpendicular and substantially parallel to the 
given plane of its curvature corresponding to a given plane of the 
cannula's curvature. The portion of the shaft means 13 having rigidity is 
divided into a first and second rigid sections 51 and 52. 
The shaft means 13 further includes a flexible section 53 which is 
positioned adjacent the distal end of the obturator between substantially 
rigid sections 51 and 52 and includes portions 60. The first flexible 
section 53 (portions 60) is of a substantially rectangular cross-section 
and has a width and thickness, with the width as measured perpendicular to 
the given plane substantially exceeding the thickness. The shaft means 13 
is easily flexible along its in the given plane of its curvature at the 
first flexible section 53, but substantially stiff in a direction 
perpendicular to the given plane because of the greater width of its 
cross-section. In this particular embodiment, the rigid sections 51 and 52 
include a first flat member 54 which has a rectangular cross-section 
corresponding to that of the flexible section 53 and is continuous 
therewith and also includes a web-like member 55 which is substantially 
perpendicular to the width of the first member 54. In this preferred 
embodiment, the flexible section 53 also includes at least one 
protuberance 57 positioned substantially perpendicular to the width of the 
flexible section 53 and spaced from the first and second rigid sections 
51,52. Accordingly, the obturator flexes at the spaces between the 
protuberance and the first and second sections. The flexible section 53 
may include more protuberances spaced apart, such that the obturator would 
flex also at the space between the protuberances. This would be 
advantageous for obturators having an extended length. Also, the 
protuberances may have different shapes, such as, for example, circular 
discs, and bead-like members similar to those discussed with respect to 
embodiments shown in FIGS. 1-6. 
The obturator is also provided with a second portion 58 which is provided 
behind the first flexible section 53 as seen along the length of the 
obturator 10 in the direction of its proximal end 12. In this embodiment, 
the second portion 58 is constituted by a raised fin member or second 
protuberance provided on the web-like member 55 of the first rigid section 
of the shaft means 13 and is so dimensioned that when the obturator 10 is 
inserted into the tracheostomy tube 100 it contacts the inner wall of the 
cannula 20 preventing the obturator from collapsing inside the cannula and 
also preventing the distal tip end of the obturator from receding into the 
cannula. This feature is extremely important since it prevents the tip of 
the obturator from being pushed up inside the tracheostomy tube while the 
physician is placing the tube into the patient. The provision of a 
flexible section within the obturator design allows the physician to 
withdraw the obturator from the tube without necessarily following the 
line of curvature of the tube. 
It will be understood that variations and modifications may be effected 
without departing from the spirit and scope of the novel concepts of the 
present invention.