CN87102349A - Do the apparatus and the method for trachea open surgery - Google Patents

Abstract

The invention provides a set of tracheotomy surgical instruments, comprising a pair of pivotable rods, one end of which is a handle, and the other end is a slender nose-shaped rod extending laterally; the two nose-shaped rods are opposite to each other. There are complementary grooves on the sides to accommodate the wire inserted into the patient's tracheal incision, its outer surface is conical, and its diameter decreases towards its outer end to facilitate insertion into the trachea; clamping handle allows two nose-shaped rods Divide to expand the tracheal incision. Simultaneously, the invention also provides a method for performing tracheal incision.

Description

Apparatus and method for performing tracheotomy

The present invention relates to a method and apparatus for inserting an intubation tube into the human body, and is particularly suitable for performing tracheostomy operations. The invention is described below in terms of its application.

The opening of the trachea is a surgical procedure that cuts into the front of the trachea, removing obstructions, and thus keeping the airway open. The operation comprises opening the trachea and placing a cannula at the opening to make the trachea unobstructed. Although this procedure is often used in emergency situations to avoid asphyxia death, the current conventional procedure is complicated and takes a considerable amount of time, about 30 minutes, and in addition, because of the large opening required, several blood vessels must be cut and ligated to the trachea, which is only possible with skilled surgeons.

It is an object of the present invention to provide devices and methods for performing tracheotomy procedures. They have many advantages over conventional devices and methods, as described in detail below.

The invention is based on a method for performing a tracheal opening operation, which comprises the following steps: the method comprises the steps of inserting a needle into the trachea, inserting a cannula into the trachea, inserting the cannula through the opening, inserting a flexible guide wire into the trachea, withdrawing the needle, inserting the guide wire through the opening, expanding the opening in the trachea, inserting a cannula into the opening, and withdrawing the guide wire.

According to one aspect of the present invention, there is provided a kit particularly useful in making tracheotomy procedures, comprising: a pair of pivotable rod members pivotally mounted to one another at intermediate positions thereof, each pivotable rod member having a handle at one end and an elongate nose-like rod at the other end extending laterally of the respective rod member, the two elongate nose-like rods having complementary recesses on opposite inside faces thereof for receiving a wire for insertion into an airway opening of a subject, the two elongate nose-like rods having substantially conical outside faces with a diameter decreasing in a direction towards their outer ends to facilitate insertion of the nose-like rods into the trachea under the guidance of a guide wire in the trachea, and the handles being clamped to one another to spread the two nose-like rods apart to facilitate insertion of a cannula into the trachea.

According to another aspect of the present invention there is provided a set of apparatus particularly suited for performing a tracheostomy procedure on a patient, comprising: the tracheal cannula comprises a cannula having a small opening formed therein for puncturing the trachea, a flexible guide wire insertable into the trachea through the needle after the trachea has been punctured and the cannula has been removed from the needle, a device for inserting the small trachea opening when the device is in a closed position and guided by the guide wire, the device being manually opened to expand the trachea incision, and a cannula inserted into the trachea after the trachea has been expanded by the device.

The above-described method of performing a tracheostomy procedure has a number of important advantages over the conventional methods currently in use: the conventional process typically takes between 20 and 30 minutes, and the new process described above can be completed in a very small fraction of the time that the conventional process takes, about a minute or less, which makes the new process particularly convenient in emergency situations where there is a risk of death from suffocation. Moreover, the new method does not require the skill of a skilled surgeon, and other physicians or assisting physicians may do the procedure with short training. In addition, the new method can be completed quickly without distinguishing and ligating blood vessels, so that it is safe, and its infection probability is low, and its compression on trachea is also low.

The new method is not only suitable for emergency situations, but also can be used as a method for hospitals to choose from.

Further features and advantages of the invention will become apparent from the following description.

The invention is described herein, by way of example only, with reference to the accompanying drawings.

FIG. 1 shows an instrument of the present invention particularly suited for use in performing tracheostomy procedures;

fig. 2 is a side elevational view of the instrument illustrated in fig. 1.

FIGS. 3a-3c show further components for use with the instrument of FIGS. 1 and 2 in performing a tracheostomy procedure in accordance with the invention;

FIGS. 4a-4j illustrate the steps for performing a tracheostomy procedure in accordance with the present invention.

Fig. 5 shows a modification of the apparatus of fig. 1 and 2.

Fig. 6 shows an improved dilator.

Fig. 7 is a fragmentary view of the instrument of fig. 6 when expanded.

Figure 8 shows a modified syringe needle.

Fig. 9 shows an improved bendable guidewire.

The instrument shown in figures 1 and 2 and designated T comprises a pair of pivotable levers 2, 3 pivotally mounted about a pin 4 in their middles, each lever comprising a handle 5 or 6 at one end of the shaft 4 and an elongate nose 7 or 8 at the other end. As shown in fig. 2, the two elongated noses 7, 8 extend laterally at an angle to the respective pivot rods 1, 2, the two pivot rods 1, 2 being urged to their closed position (as shown in fig. 1) by a pair of springs 9, 10 and being locked in the closed position by a latch member 11, the latch member 11 being located outside and adjacent to the pivot pin 4 and pivotally mounted at the mouth to the rod 6.

The two elongated noses 7, 8 have semi-cylindrical slots 13 on their inner facing surfaces, the two semi-cylindrical slots 13 being complementary to each other to form a cylindrical cavity for receiving a guide wire (30, fig. 3 b) when the instrument is in the closed position as shown. The outer sides of the two noses 7, 8 are conically shaped with a diameter which decreases uniformly from their interface 14 with the respective pivot rod 5, 6 to their outer end 15.

In addition to the instruments shown in figures 1 and 2, other components for performing tracheostomy procedures include a syringe as shown in figure 3a, a flexible guide wire as shown in figure 3b, and a cannula having a round mandrel as shown in figure 3 c. The procedure followed for using these instruments will be described with reference to fig. 4a-4 j. Syringe 20 (fig. 3 a) includes a fluid chamber 21, e.g. for holding saline, a plunger 22, and a syringe needle 23 removably attached to the syringe, the needle 23 having an enlarged cannula shoulder 24 at its connecting end. Syringe 20 is used to pierce the trachea with syringe needle 23, forming a small hole in the trachea, and the liquid in syringe chamber 21 is used to indicate when needle 23 has fully penetrated the trachea. Thus, when the trachea is pierced by the syringe needle 23, the plunger 22 is pulled outwardly to aspirate the liquid chamber 21, so that as soon as the trachea is pierced, gas is drawn from the trachea into the liquid in the liquid chamber 21, creating bubbles in the chamber which are easily observed by the operator.

Wire 30 (fig. 3 b) is a small diameter flexible wire having an outer diameter smaller than the inner diameter of needle 23. The arrangement is such that the needle extends through the trachea and, after the syringe has been removed from the needle, the guide wire 30 is inserted into the trachea via the intra-needle passage. The needle is then removed, with wire 30 acting as a guide to guide the instrument of figures 1 and 2 within the small opening of the trachea. The instrument is used to enlarge the opening to accommodate the mandrel 50 and cannula 60 shown in figure 3c, which are also inserted into the enlarged opening under the guidance of the wire 30. The guide wire is then withdrawn.

The mandrel 50 (see fig. 3 c) includes a hole 55 through its entire length, a flared head 56 at one end, and a conically curved end 57 at the other end.

The interior of the cannula 60 (fig. 3 c) which, together with the mandrel 50, fits into the flared opening in the trachea has a passageway for receiving the mandrel 50 and an enlarged tip 66 which is connectable to a suction device. The opposite end 67 of the cannula 60 is curved as shown and is followed by a balloon 68. the balloon 68 is inflatable to occlude the trachea and allow the injected air to enter the patient's lungs without exiting the mouth or nose. The cannula 66 is provided with a tubule 69 leading to a balloon 68 for inflating the balloon when the cannula is inserted into the trachea. The tubule 69 preferably includes another balloon 69' which expands to indicate that the balloon 68 within the tubule is inflated.

The enlarged end 24 of the syringe needle 23 may also be connected to an air pump to inject air into the trachea during emergency treatment.

Figures 4a-4j illustrate the steps involved in performing a tracheostomy procedure using the apparatus shown in figures 1-2 and 3a-3 c.

Fig. 4a shows the normal position of the patient before the start of the operation, and fig. 4b shows the step of palpating the patient's throat to determine the location of the trachea. This is not difficult to do because the trachea is relatively thick.

After the trachea has been so located, a small hole is made in the trachea with the syringe 20 by advancing the syringe needle 23 into the trachea (figure 4 c). During this process, plunger 27 is pulled slightly outward to continue aspiration of the syringe chamber so that when the syringe needle fully penetrates the tracheal wall, air can be immediately drawn into syringe chamber 21 and form an air bubble therein, as shown in fig. 4 b. Once the air bubble is present, the syringe is removed from the needle, leaving the needle in the trachea. The guide wire 30 is then passed through the syringe needle into the trachea (see figure 4 e) whereupon the syringe needle is removed, leaving the guide wire in the trachea (see figure 4 f).

The instrument shown in figures 1 and 2 is then used to expand a small opening in the trachea. The process is as follows: the instrument is locked in this position by turning the lock 11 to a position which avoids squeezing the handles 5, 6 together and thereby opening the two noses 7, 8 as shown. When the two noses 7, 8 of the instrument are in the closed position as shown, it is convenient to guide the noses into the small opening formed in the trachea by passing a guide wire 30 through the holes 13 formed by the semi-cylindrical slots on the opposite sides of the two noses (see figure 4 g), since the outer surfaces of the two noses are tapered.

The locking piece 11 is then turned to a release position allowing the handles 5, 6 to be pressed towards each other, squeezing the handles 5, 6 to move the noses 7, 8 at the other end away from each other (see fig. 4 h), thereby enlarging the opening in the trachea.

When the tracheal opening is large enough, the guide wire 30 is withdrawn, the instrument is used to keep the opening wide, and the mandrel 50 and cannula 60 are inserted into the tracheal opening (see FIG. 4 i). The mandrel 50 and guidewire 30 are then removed (fig. 4 j), leaving only the cannula 60 in the tracheal opening. The balloon 68 at the end of the cannula is then inflated to block access to the mouth and nose of the patient's trachea, thereby ensuring that air passing through the cannula can enter the patient's lungs and exit the patient's mouth and nose. The balloon 68 is suitably inflated as indicated by the degree of expansion of a small balloon 70 outside the trachea.

As previously indicated, if an emergency situation arises in the middle of any step before the procedure is completed, air can be injected into the trachea through the flared tip 24 of the needle 23.

The function of the mandrel 50 is to ease the entry of the cannula 60 into the trachea. The mandrel is inserted into the tracheal opening with the cannula and once the cannula is properly placed in the opening, the mandrel is withdrawn. If desired, the mandrel 50 may be releasably attached to the cannula 60 by fitting a bayonet pin to the mandrel and making a bayonet slot in the cannula so that the mandrel and cannula are connected together during insertion of the two into the trachea, after which the mandrel may be rotated slightly to remove the pin from the slot in the cannula and the mandrel may be withdrawn leaving the cannula in the opening.

This step can be completed in 30-60 seconds, whereas a conventional tracheostoma procedure takes 20-30 minutes. This is particularly useful in emergency situations where the surgeon is not available, where time savings are a significant benefit, where the surgical rules are relatively few and the general physician or assisting physician can be competent without the skill of the surgeon, and where the surgical procedure does not involve cutting arteries or veins, which is safer and less likely to cause infection than conventional methods.

The nose bars 7, 8 of the apparatus shown in figures 1 and 2 are preferably both 20-30 mm in length. The angle to each of the eye pivot rod members is in the range of 90-130 deg., with the outward diameter being from 1-2.5 mm at the outer end 15 to 3-5 mm at their interface with the respective pivot rod member 2, 3. In the preferred embodiment shown in figures 1 and 2, the nose bar has a length of 25 mm and an angle of about 100 degrees with the pivot bar 2.3, and the outer diameter increases from 2 mm to 4 mm. The semi-cylindrical slot 13 has a diameter slightly larger than the diameter of the guide wire 30 it receives. In the preferred embodiment described above, the bendable guidewire has a diameter of 1.0 mm and the slot on the opposite side of the nose bar has a slightly larger diameter of about 1.5 mm.

Fig. 5 shows a modified version of the structure of the device T of fig. 1 and 2. For ease of comparison, like parts are labeled with like reference numerals.

As can be seen from the modification of figure 5, the pivotal lock 11 is omitted and instead a pair of links 71, 72 at the outer ends of the handles 5, 6 are provided to lock the handles in the closed position of the instrument as shown. The two links 71 and 72 are therefore pivotally mounted to each other at their inner ends, 73 in the figure, and are pivotally connected to the respective handles 5, 6 at their outer ends. The arrangement is such that when the links are in line as shown in solid lines in figure 5 they lock the handles in their closed condition, but when the links are not in line (this can only be achieved by pushing the pivot 73 outwards), the links release the handles so that they can be squeezed towards each other, thereby separating the nosebars 7, 8 when the opening is expanded by the method described above.

Figures 6 and 7 show an improved extender. It is equipped with a protection device. The device, generally designated 200, is located at the interface of the pivotable levers 102 and 103 and their elongated nose levers 107 and 108 to prevent inadvertent subcutaneous penetration. The guard 200 includes two sections 201 and 202 that are secured at the intersection of the pivotable levers 102 and 103 and their respective elongated nose bars 107 and 108 so that the guard 200 opens (see fig. 7) and closes (see fig. 6) with the nose bars.

The inner portions 201 and 202 of the guard are both thin sheets, similarly quarter-circular in shape, and are all substantially parallel to the respective pivot rods 102 and 103, so that when the rods are in the closed position (see fig. 6), the two portions together form a substantially semi-circular guard with a diametric edge 200a substantially flat with the elongate nose bar and a curved edge 200 extending primarily under the elongate nose bar.

The elongate nose bars 107, 108 are at an angle of 115 deg. to the respective pivot rod members 102, 103. In addition, the tip of each elongated nose bar is tapered, preferably at 30 degrees, as shown at 107a and 108 a.

According to a further modification of the extender shown in figures 6 and 7, brake levers 205 and 206 are mounted on the inner faces of both handles 105 and 106. Thus, when the handle is squeezed, the two brake levers are pushed together and constrained to each other, thereby limiting the opening range of the elongated nose-shaped lever.

According to another refinement, the syringe needle 23 comprises a grip tab 210 (see fig. 8) for holding the needle when the needle is separated from the rest of the syringe, including the syringe chamber and the plunger. In addition, the syringe needle is slightly curved at its outer end, as shown at 23a in fig. 8. This configuration has been found to be advantageous in situations where the needle is initially introduced into the trachea by first inserting the needle through the skin and into the trachea alone (i.e. without the remainder of the syringe) and then applying the syringe to the enlarged mouth 24 of the needle. As will be described specifically below.

According to another modification, the metallic guidewire 30, as shown in fig. 9, includes an inner flexible core 220 and an outer flexible coil 222. One end of the outer coil is fixed, such as by spot welding or gluing at 226, to the inner core 220, with the outer end of the coil extending beyond the outer end of the core to form a pointed tapered end 222 a. This arrangement has been found to be advantageous for feeding a flexible guide wire into the trachea via the syringe needle.

The procedure for performing the tracheostomy procedure is substantially the same as that described with reference to fig. 4aj, but modified in the following ways:

the patient should lie flat and the shoulders raised (back up) as with a rolled sheet or blanket. The physician squeezes (Pulpates) the trachea and positions it two centimeters above the suprasternal notch (supra-thoracic notch).

The physician (who should stand behind the patient) grasps the finger grip tab 210 on the syringe needle 23 and inserts the needle into the trachea from between the cartilage rings, an operation which is easily performed due to the curvature of the needle end. The syringe (not shown in the drawings) is then snapped onto the needle. In this case, the liquid chamber of the syringe can be filled with air only, and the plunger is drawn outwards to confirm whether the puncture on the trachea is completed, so that the movement of the syringe is relatively easy after the puncture is completed. Once the puncture is confirmed to be completed, the needle is no longer advanced, thus ensuring penetration of the anterior wall of the trachea without touching the posterior wall. The syringe needle is then removed by grasping tab 210 with the fingers and left in the trachea.

The flexing of the syringe needle facilitates this type of penetration through the anterior wall of the trachea without penetrating the posterior wall.

After removal of the syringe, the guide wire 30 is inserted into the trachea through the hollow of the needle 23 until the guide wire has been fully inserted into the trachea. This operation is facilitated by the outer coil 222 of the guide wire 30, and in particular the tapered end 222a of the coil that extends beyond the outer end of the inner core wire 220. The needle is then removed, leaving the guidewire in the trachea.

Next, the stent of FIGS. 6 and 7 is closed so that its nose bars 107, 108 are positioned over the guide wire (which is located in a semi-circular recess in the nose bars) and the instrument is secured in the locked position by locking links 171 and 172, as shown in FIG. 6. The locking links 171, 172 are then opened and the handles 105, 106 are squeezed to spread the elongated nose bars 107, 108 apart, thereby expanding the opening through the trachea. The open position of the elongated nose bars 107, 108 is limited by the engagement of the detent bars 205 and 206 by the handles 105, 106. The metal guidewire is then removed and inserted into the cannula in the same manner as previously described.

Although the invention has been described above with reference to a preferred embodiment, it should be understood that many other variations, modifications and applications of the invention may be made. For example, the described instruments and techniques may also be used to introduce a cannula or similar object into other parts of the human body.

Claims (10)

1. An instrument particularly suited for use in performing tracheostomy procedures on a patient, comprising a pair of pivotally mounted members at intermediate positions thereof, each of said pivotally mounted members including a handle at one end and an elongate nose bar at the other end thereof, said nose bars extending transversely of their respective pivotal members; complementary recesses are formed on opposite sides of the two elongated nose bars for receiving a guidewire inserted into the patient's tracheal opening; the outer surfaces of the two elongated nose bars are substantially conical, the diameters of which decrease in a direction towards their outer ends, thereby facilitating insertion of the nose bars into the trachea opening under the guidance of a guide wire in the trachea opening; the elongated noses can be separated by clamping the handles toward each other to expand the tracheal opening to facilitate insertion of the cannula into the tracheal opening under the guidance of the guidewire.

2. The apparatus of claim 1, further comprising: a spring for urging the pair of pivotable levers to the closed position with the inner surfaces of the nose bars abutting each other, and a locking tab for locking the pair of pivotable levers to the closed position. The locking tab is manually operable to release the pair of pivotable levers, allowing the handles thereof to be squeezed toward each other, separating the nose levers.

3. The instrument of claim 2, wherein the latch means comprises a pair of links pivotally mounted to one another at inner ends and each pivotally connected at outer ends to a respective handle.

4. The apparatus of any one of claims 1 to 3 wherein the nose bars are at an angle of 90 to 135 degrees to the respective pivot bar members and extend 20 to 30 mm.

5. An apparatus according to any one of claims 1 to 4, further comprising a guard located at the interface of the pivot member and its nose stem to prevent inadvertent subcutaneous penetration.

6. The apparatus of claim 5, wherein said guard comprises two pieces, each piece being secured at the interface of a respective pivot rod member and its nose rod.

7. The device of claim 6, wherein each of said guards is a flat plate having a quarter-circle shape and extending substantially parallel to the respective pivot rod member. Thus, when the pair of pivot levers are in the closed position, the two pieces of the guard together form a nearly semicircular guard. Its diameter lies substantially flush with the straight edge of the nose bar and its curved edge lies below the nose.

8. Apparatus particularly adapted for use in performing a tracheostomy procedure on a patient, comprising: a device for insertion of a tracheal tube, comprising a syringe with a syringe needle for forming a small opening against the trachea to puncture the trachea, a flexible guide wire which can be inserted through the needle into the trachea after the trachea has been penetrated and the syringe has been removed, an instrument according to any one of claims 1 to 7 for insertion into the small opening in the trachea when in the closed position, guided by the flexible guide wire, said instrument being manually openable to enlarge the opening in the trachea, and an insertion tube for insertion into the opening in the trachea which has been expanded by said instrument.

9. The device of claim 8 wherein the syringe needle is removably secured to one end of the syringe and has an annular shoulder at said end to limit penetration of the trachea.

10. The device according to any one of claims 8 and 9, wherein the cannula has a through bore for receiving a mandrel, the mandrel also having a through bore for receiving a guide wire to facilitate insertion of the cannula with the mandrel into the tracheal opening enlarged by the device.

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