Cricothyrotomy surgical tool with bougie passage and retractable scalpel blade

Abstract

A surgical tool includes (i) a tool body with a longitudinal bougie passage extending through the tool body to receive a bougie therethrough and (ii) a blade body mounting a scalpel on one end thereof. When the bougie is removed, the blade body can be inserted through the bougie passage so that the scalpel blade protrudes from the end of the tool body in a working position. The surgical tool is suited for performing a cricothyrotomy procedure by incising the cricothyroid membrane in the working position of the scalpel blade, followed by retraction of the scalpel blade to allow insertion of the bougie through the bougie passage while the tool body remains in place within the incision. The tool body can then be removed from the bougie and replaced with an endotracheal tube, prior to removal of the bougie from the incision.

Description

[0001] CRICOTHYROTOMY SURGICAL TOOL WITH BOUGIE PASSAGE AND RETRACTABLE SCALPEL BLADE

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a surgical tool having a bougie passage extending through a tool body of the surgical tool for insertion of a bougie therethrough and a retractable scalpel blade, and more particularly the present invention relates to a surgical tool for use performing an incision and for guiding insertion of a bougie into the incision for subsequently guiding an endotracheal tube in a cricothyrotomy procedure. BACKGROUND

[0004] Intubation of the trachea is a common medical procedure. The standard technique involves placing the endotracheal tube into the mouth, down the throat, through the vocal cords and into the trachea. When the trachea cannot be intubated in the standard fashion, the final backup plan is cricothyrotomy. Cricothyrotomy is an emergency procedure that involves placing an endotracheal tube through the cricothyroid membrane (at the front of the neck) into the trachea. Every setting where intubations occur must be prepared to perform an emergency cricothyrotomy and accordingly, all emergency departments and other settings where intubation may occur make provisions for emergency cricothyrotomy, typically according to one of the following procedures.

[0005] Cricothyrotomy procedure A. The most common procedure involves placing a needle on a syringe through the cricothyroid membrane, remove the syringe, introduce a guidewire through the needle through the cricothyroid membrane and into the trachea, remove the needle which leaves the guidewire through the cricothyroid membrane and in the trachea, cut alongside the guidewire with a scalpel, introduce an endotracheal tube / attached dilator over the guidewire, remove the guidewire / dilator. The endotracheal tube is left in place and used to ventilate the patient.

[0006] Cricothyrotomy procedure B. The above Procedure A has been criticized for being overly cumbersome and too time consuming to carry out during an airway crisis. The current generally recommended procedure, according to many emergency medicine authorities, is to use a scalpel to incise the skin vertically over the cricothyroid membrane, incise the membrane itself horizontally, insert finger through the cricothyroid membrane, remove scalpel, insert bougie through the cricothyroid membrane alongside finger, insert endotracheal tube through the cricothyroid membrane and into the trachea - using the bougie as a guide. There is still concern that using Procedure B involves placing one’s finger in close proximity to the scalpel blade (risk for injury) and / or involves entering and exiting the cricothyroid membrane with various items which increases the risk of a false tract. Such risk would be greatest among those with neck obesity since the pathway from the skin surface into the airway is long and could become lost. Such misplacement of the endotracheal tube would lead to a catastrophic airway failure.

[0007] SUMMARY OF THE INVENTION

[0008] According to one aspect of the invention there is provided a urgical tool for use with a bougie, the tool comprising: a tool body which is elongated in a longitudinal direction between a first end and a second end; a bougie passage formed on the tool body to extend in the longitudinal direction between a first opening at the first end of the tool body and a second opening in proximity to the second end of the tool body, the bougie passage being arranged to receive the bougie longitudinally slidable through the tool body; and a blade body supporting a scalpel blade on a first end of the blade body, the blade body being arranged to be supported relative to the tool body for longitudinal movement between a working position in which the blade body is at least partially received within the bougie passage such that the scalpel blade extends from the first opening in the tool body and protrudes longitudinally from the first end of the tool body and a retracted position in which the blade body is displaced longitudinally relative to the working position; wherein the bougie passage allows passage of the bougie therethrough in the retracted position of the blade body.

[0009] Preferably the bougie passage is fully unobstructed by the blade body and the scalpel blade in the retracted position of the blade body.

[0010] The bougie passage may extend linearly between the first opening at the first end of the tool body and the second opening at the second end of the tool body.

[0011] Preferably the bougie passage spans a full length of the tool body.

[0012] Preferably the first opening has a smaller diameter than the second opening.

[0013] The tool body may include a tapered portion adjacent to the first end of the tool body in which an exterior dimension of the tool body along the tapered portion is tapered towards the first opening.

[0014] The tool body may further include a retention portion adjacent to the first end of the tool body in which an interior dimension of bougie passage at the retention portion is reduced relative to an interior dimension of the bougie passage adjacent the second end of the tool body such that the retention portion is arranged to f nationally retain the first end of blade body therein by interference fit in the working position of the blade body.

[0015] An exterior of the tool body may include a gripping texture formed thereon along at least a portion of the tool body between the first end of the tool body and the second end of the tool body. Preferably the gripping texture extends along a majority of a length of the tool body between the first the end of the tool body and the second end of the tool body. The gripping texture may comprise a plurality of circumferentially extending ribs at longitudinally spaced locations along the tool body.

[0016] The scalpel blade preferably has a maximum dimension transverse to the longitudinal direction which is approximately equal to a diameter of the first opening of the bougie passage at the first end of the tool body.

[0017] In the illustrated embodiment, the blade body is slidably removable from the tool body in the retracted position. Preferably the blade body is removable from the tool body through the second opening of the bougie passage in the retracted position.

[0018] A combined length of the blade body and the scalpel blade is preferably greater than a length of the tool body in the longitudinal direction.

[0019] The blade body preferably extends through the second opening of the bougie passage so as to protrude longitudinally from the second end of the tool body in the working position of the blade body.

[0020] Preferably the tool body and the blade body are formed of plastic material.

[0021] The tool body may be formed of a translucent or transparent material.

[0022] The blade body may comprise (i) a follower portion adjacent the first end of the blade body having an exterior dimension arranged to be supported for longitudinal sliding relative to the bougie passage and (ii) a gripping portion spanning part of a length of the blade body between the follower portion at the first end and an opposing second end of the blade body in which the gripping portion is reduced in width relative to the follower portion in a lateral direction that is oriented perpendicularly to a plane of the scalpel blade. According to another aspect of the present invention, the surgical tool described above is used to perform a cricothyrotomy procedure on a patient.

[0023] According to another aspect of the present invention there is provided a method of using the tool according to any preceding aspects to perform a cricothyrotomy procedure on a patient, the method including: using the scalpel blade in the working position to incise a cricothyroid membrane of the patient; displacing the blade body into the retracted position while keeping the tool body in place through the cricothyroid membrane of the patient; inserting the bougie through the bougie passage in the tool body such that the bougie is directed into a trachea of the patient; removing the tool body from the patient while keeping the bougie directed into the trachea of the patient; introducing an endotracheal tube into the trachea of the patient over the bougie; and removing the bougie from the patient while keeping the endotracheal tube directed into the trachea of the patient.

[0024] The method preferably further comprises displacing the blade body into the retracted position by removing the blade body from the tool body through the second opening of the bougie passage prior to inserting the bougie through the bougie passage.

[0025] BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Various embodiments of the invention will now be described in conjunction with the accompanying drawings in which:

[0027] Figure 1 is a perspective view of the surgical tool with the blade body inserted into the tool body in proximity to the working position according to one embodiment of the present invention;

[0028] Figure 2 is a sectional view along the line 2-2 in Figure 1 ;

[0029] Figure 3 is a perspective view of the surgical tool according to the embodiment of Figure 1 in which the blade body is shown removed from the tool body to allow insertion of a bougie through the tool body in place of the blade body;

[0030] Figure 4 is a top plan view of the blade body shown removed from the tool body of the surgical tool according to the embodiment of Figure 1 ;

[0031] Figure 5 is a side elevational view of the blade body shown removed from the tool body of the surgical tool according to the embodiment of Figure 1 ; and

[0032] Figures 6 through 11 are schematic representations of the various steps involved in a cricothyrotomy procedure using the surgical tool according to the embodiment of Figure 1 .

[0033] In the drawings like characters of reference indicate corresponding parts in the different figures.

[0034] DETAILED DESCRIPTION

[0035] Referring to the accompanying figures there is illustrated a surgical tool generally indicated by reference numeral 10. The tool 10 is particularly suited for use in a cricothyrotomy procedure as described in further detail below.

[0036] The surgical tool 10 generally includes a tool body 12 and a blade body 26 that is received within the tool body 12. The tool body 12 is elongated in a longitudinal direction between a working first end 14 and an opposing second end 16. The tool body defines a bougie passage 18 extending longitudinally through the tool body from a first opening 20 at the first end of the tool body to a second opening 22 at the second end of the tool body so as to receive a bougie 24 extending through the tool body. The bougie passage 18 extends linearly through the tool body 12 along a full length of the tool body.

[0037] The blade body 26 supports a scalpel blade 28 thereon at a first end of the blade body such that the scalpel blade is movable with the blade body between a working position in which the blade body at least partially occupies the bougie passage 18 so that the scalpel blade protrudes from the first end of the tool body through the first opening 20 of the bougie passage and a retracted position in which the blade body is retracted longitudinally inward relative to the working position so as not to interfere or obstruct placement of a bougie 24 extending through the bougie passage to protrude from the first opening 20. The blade body may be removed from the tool body in the retracted position such that the bougie passage is fully unobstructed by the blade body and the scalpel blade in the retracted position of the blade body.

[0038] The tool body 12 according to the illustrated embodiment is similar to the body of a syringe so as to have a tubular main portion 30 defining the bougie passage 18 extending longitudinally therethrough. A conical or tapered end portion 32 is supported at the first end of the tool body such that the outer diameter of the main portion 30 is longitudinally tapered inwardly to be reduced in outer diameter or exterior dimension along the conical end portion from the main portion to the first opening 20 located at the end of the tool body. The first opening 20 is coaxially aligned with the conical end portion 32 and the tubular main portion 30.

[0039] The bougie passage 18 extends linearly through the tool body from the first opening 20 at the first end to the second opening 22 at the opposing end of the body. The bougie passage has a near constant interior diameter along the tubular main portion 30 of the tool body between the second opening and the conical end portion 32 of the body; however, in inner end portion adjacent the first end of the tool body defines a retention portion 33 wherein the interior diameter or dimension of the bougie passage is reduced relative to the remaining portion of the interior diameter or dimension of the bougie passage extending to the second end of the tool body. The retention portion serves to frictionally retain the first end of blade body therein by interference fit in the working position of the blade body.

[0040] The interior diameter is further reduced through the conical end portion towards the first opening which has a diameter that is smaller than the interior diameter of the main portion 30 and smaller than the diameter of the second opening 22.

[0041] The tool body 12 further includes a gripping texture on the exterior of the tubular main portion 30 of the tool body to extend along a majority of a length of the tool body between the conical end portion 32 and the opposing second end of the tool body. In the illustrated embodiment, the gripping texture comprises circumferentially extending ribs 34 at longitudinally spaced positions for gripping between two fingers of the user along any portion of the length of the tool body.

[0042] The exterior of the conical end portion 32 is smooth and uninterrupted between the first opening 20 and the tubular main portion 30.

[0043] The entirety of the tool body 12 is formed as a singular, unitary body formed of plastic material that is translucent or transparent.

[0044] The blade body 26 is formed similarly to the plunger portion of a syringe so as to be slidably received within bougie passage 18 of the tool body 12 in use. More particularly, the blade body includes a follower portion 36 having a diameter that is snugly received within the interior diameter of the tubular main portion 30 of the tool body in proximity to a first end of the blade body, and a shaft portion 38 extending longitudinally from the follower portion 36 to an opposing second end of the body. The shaft portion 38 is formed of a moulded plastic material as a unitary body similarly to the tool body. The follower portion 36 may comprise a ring of resilient gripping material which is secured about the blade body in proximity to the first end so as to be sized for longitudinal sliding within the tubular main portion 30 of the tool body while being somewhat radially compressed to provide a retaining friction that retains the longitudinal position of the blade body relative to the tool body while still enabling the friction to be overcome so as to allow relative sliding of the blade body relative to the tool body when desired. The reduced diameter of the retention portion 33 is undersized relative to the follower portion 36 such that the follower portion 36 can be frictionally retained by interference fit in the working position of the blade body relative to the tool body with sufficient force to enable the blade body to remain fixed relative to the tool body while using the scalpel blade to incise tissue during a surgical procedure.

[0045] The shaft portion 38 may include a secondary guide portion 40 formed thereon at a location spaced longitudinally from the follower portion 36 and having an outer diameter which is slightly less than the inner diameter of the tubular main portion 30 so as to assist in guiding parallel and coaxial alignment of the blade body with the tool body when the blade body is received within the bougie passage 18 of the tool body.

[0046] The shaft portion 38 of the blade body has a suitable length such that when the follower portion 36 is abutted at the end of the tubular main portion 30 directly adjacent to the conical end portion 32 at the first end of the tool body according to the working position, the opposing second end of the shaft portion 38 of the blade body protrudes outwardly beyond the second end of the tool body by extending outwardly through the second opening 22 of the bougie passage 18.

[0047] A grip member 42 is mounted on the second end of the shaft portion 38 of the blade body in the form of a circular plate oriented perpendicularly to the longitudinal axis to provide a flat surface for pushing the blade body into the tool body. In this manner the tool body is suited for gripping similarly to the manner a syringe is gripped in which the tool body is received between fingers of the user which grip the gripping texture of the ribs 34 while the thumb of the user can be aligned with the grip member 42 at the exposed end of the blade body for pushing the blade body into the tool body up to the working position.

[0048] In further embodiments, the tool body may be provided with a further latch or pin type structure which is operatively connected between the tool body and the blade body in proximity to the second ends thereof to securely fix the blade body in the working position relative to the tool body in a releasable manner.

[0049] The scalpel blade 28 is mounted on the first end of the blade body to extend in the longitudinal direction of the blade body. The maximum dimension of the scalpel blade in a direction perpendicularly to the longitudinal axis is approximately equal to or less than the diameter of the first opening 20 of the bougie passage 18 so that the scalpel blade 28 can be readily received protruding through the first opening 20 in the working position. The length of the scalpel blade relative to the conical end portion 32 of the tool body is such that the scalpel blade 28 protrudes and is exposed in an operative state from the first end of the tool body for cutting tissues in a surgical operation in the working position.

[0050] The entirety of the blade body is formed as a single unitary body of plastic material with the exception of the scalpel blade 28 mounted on the first end that is formed of metal and the follower ring 36 formed of a resilient rubberlike material mounted about the shaft portion in proximity to the first end of the blade body.

[0051] The shaft portion 38 of the blade body includes a gripping portion 39 at an intermediate location along part of the length of the blade body between the secondary guide portion 40 adjacent the follower portion 36 at the first end of the blade body and the grip member 42 at the opposing second end of the blade body. At the gripping portion 39, the thickness of the blade body is reduced in a lateral direction in which the lateral direction is defined as being perpendicular to the plane occupied by the scalpel blade. In this manner, the overall cross-sectional shape of the gripping portion 39 is approximately rectangular with two parallel and opposing side walls 41 being defined that are parallel and laterally spaced, while spanning nearly the full diameter of the bougie passage in a transverse direction that is perpendicular to the lateral direction. The cross-sectional shape along the gripping portion 39 is thus elongated in transverse direction that is defined as being parallel to the plane of the scalpel blade and perpendicular to the longitudinal direction of the bougie passage. A gripping texture of ribs 43 are also provided along part of the gripping portion 39 adjacent to the first end of the blade body. The blade body 26 is thus suited for gripping at the gripping portion 39 similar to a convention scalpel body for use of the blade body as a scalpel independently of the tool body 12 if desired.

[0052] As described and illustrated herein, the blade body 26 substantially fully occupies the bougie passage 18 of the tool body in the working position when fully inserted into the tool body. In the working position shown in figure 2, the scalpel blade 28 protrudes longitudinally through the first opening of the bougie passage relative to the first end of the tool body while the opposing end of the blade body protrudes longitudinally through the second opening 22 beyond the second end of the tool body as a result of the combined length of the scalpel blade and the blade body being greater than the corresponding length of the tool body.

[0053] The scalpel blade is retracted into a retracted position by longitudinally sliding the blade body relative to the tool body such that the scalpel blade is retracted through the first opening 20 of the tool body. The user continues to retract the blade body until the blade body is fully removed through the second opening 22 in the tool body to separate the blade body from the tool body as shown in figure 1. Once the blade body has been fully removed from the tool body in the retracted position, the bougie passage 18 is fully unobstructed by the blade body or the scalpel blade so that the bougie 24 can be longitudinally inserted through the tool body 12 by inserting the bougie into the second opening 22 until the bougie protrudes outwardly from the first opening 20.

[0054] The surgical tool 10 may be provided as a kit in which the entirety of the kit consists of: (i) the tool body and the blade body of the tool 10 described above in which a #1 1 scalpel blade is mounted to the plunger of the syringe and the barrel of the syringe has a conical opening, (ii) a bougie, and (iii) a 6 mm internal diameter cuffed endotracheal tube 44.

[0055] When performing a cricothyrotomy with the surgical tool 10 described above, the operator initially incises the skin overlying the cricothyroid (CT) membrane vertically, and then incises the CT membrane horizontally as schematically represented in figure 6. The blade body or plunger (with attached scalpel blade) is then withdrawn, keeping the end of the tool body or syringe with conical opening in place though the CT membrane as shown in Figure 7. The tool body or syringe (in place through the CT membrane) is directed caudally and the bougie is then introduced through the tool body or syringe, through the CT membrane into the trachea as represented in Figure 8. As represented in Figure 9, the user then confirms bougie position in the trachea with palpable clicks from the trachea rings and advances the bougie to a predetermined depth (mark on bougie), followed by removal of the tool body or syringe, while holding the bougie in place. A 6 mm internal diameter endotracheal tube 44 is then introduced over the bougie into the trachea, using the bougie as a guide, as shown in Figure 10. Finally, as shown in Figure 11 , the bougie is removed so that the cuff of endotracheal tube can be inflated with 10 cc air, followed by ventilating though the endotracheal tube and suturing the endotracheal tube in place. Since various modifications can be made in my invention as herein above described, and many apparently widely different embodiments of same made, it is intended that all matter contained in the accompanying specification shall be interpreted as illustrative only and not in a limiting sense.

Claims

CLAIMS:1 . A surgical tool for use with a bougie, the tool comprising: a tool body which is elongated in a longitudinal direction between a first end and a second end; a bougie passage formed on the tool body to extend in the longitudinal direction between a first opening at the first end of the tool body and a second opening in proximity to the second end of the tool body, the bougie passage being arranged to receive the bougie longitudinally slidable through the tool body; and a blade body supporting a scalpel blade on a first end of the blade body, the blade body being arranged to be supported relative to the tool body for longitudinal movement between a working position in which the blade body is at least partially received within the bougie passage such that the scalpel blade extends from the first opening in the tool body and protrudes longitudinally from the first end of the tool body and a retracted position in which the blade body is displaced longitudinally relative to the working position; wherein the bougie passage allows passage of the bougie therethrough in the retracted position of the blade body.

2. The tool according to claim 1 wherein the bougie passage is fully unobstructed by the blade body and the scalpel blade in the retracted position of the blade body.

3. The tool according to claim 1 or claim 2 wherein the bougie passage extends linearly between the first opening at the first end of the tool body and the second opening at the second end of the tool body.

4. The tool according to any one of claims 1 through 3 wherein the bougie passage spans a full length of the tool body.

5. The tool according to any one of claims 1 through 4 wherein the first opening has a smaller diameter than the second opening.

6. The tool according to any one of claims 1 through 5 wherein the tool body includes a tapered portion adjacent to the first end of the tool body in which an exterior dimension of the tool body along the tapered portion is tapered towards the first opening.

7. The tool according to any one of claims 1 through 6 wherein the tool body includes a retention portion adjacent to the first end of the tool body in which an interior dimension of bougie passage at the retention portion is reduced relative to an interior dimension of the bougie passage adjacent the second end of the tool body such that the retention portion is arranged to f nationally retain the first end of blade body therein by interference fit in the working position of the blade body.

8. The tool according to any one of claims 1 through 7 wherein an exterior of the tool body includes a gripping texture formed thereon along at least a portion of the tool body between the first end of the tool body and the second end of the tool body.

9. The tool according to claim 8 wherein the gripping texture extends along a majority of a length of the tool body between the first the end of the tool body and the second end of the tool body.

10. The tool according to claim 8 or claim 9 wherein the gripping texture comprises a plurality of circumferentially extending ribs at longitudinally spaced locations along the tool body.1 1 . The tool according to any one of claims 1 through 10 wherein the scalpel blade has a maximum dimension transverse to the longitudinal direction which is approximately equal to a diameter of the first opening of the bougie passage at thefirst end of the tool body.

12. The tool according to any one of claims 1 through 1 1 wherein the blade body is slidably removable from the tool body in the retracted position.

13. The tool according to claim 12 wherein the blade body is removable from the tool body through the second opening of the bougie passage in the retracted position.

14. The tool according to any one of claims 1 through 13 wherein a combined length of the blade body and the scalpel blade is greater than a length of the tool body in the longitudinal direction.

15. The tool according to any one of claims 1 through 14 wherein the blade body extends through the second opening of the bougie passage so as to protrude longitudinally from the second end of the tool body in the working position of the blade body.

16. The tool according to any one of claims 1 through 15 wherein the tool body and the blade body are formed of plastic material.

17. The tool according to any one of claims 1 through 16 wherein the tool body is formed of a translucent or transparent material.

18. The tool according to any one of claims 1 through 17 wherein the blade body comprises a follower portion adjacent the first end of the blade body having an exterior dimension arranged to be supported for longitudinal sliding relative to the bougie passage and a gripping portion spanning part of a length of the blade body between the follower portion at the first end and an opposing second end of the blade body in which the gripping portion is reduced in width in a lateral direction that is oriented perpendicularly to a plane of the scalpel blade.

19. A method of using the tool according to any one of claims 1 through18 to perform a cricothyrotomy procedure on a patient, the method including: using the scalpel blade in the working position to incise a cricothyroid membrane of the patient; displacing the blade body into the retracted position while keeping the tool body in place through the cricothyroid membrane of the patient; inserting the bougie through the bougie passage in the tool body such that the bougie is directed into a trachea of the patient; removing the tool body from the patient while keeping the bougie directed into the trachea of the patient; introducing an endotracheal tube into the trachea of the patient over the bougie; and removing the bougie from the patient while keeping the endotracheal tube directed into the trachea of the patient.

20. The method according to claim 19 further comprising displacing the blade body into the retracted position by removing the blade body from the tool body through the second opening of the bougie passage prior to inserting the bougie through the bougie passage.

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