Device for grasping and securing a tracheal tube bougie

Abstract

The present invention relates to a device for grasping and securing a tracheal tube stylet. A device for a tracheal tube that allows medical personnel to grasp and secure a stylet within the device and maintain a curved orientation during a tracheal tube procedure. The device includes a locking ring for retaining the stylet during use.

Description

TECHNICAL FIELD

[0001] The present invention relates to a bougie device and methods of using the same, and more particularly, to a device for grasping and guiding a bougie device suitable for guiding the insertion of an endotracheal tube into the airway of a person. BACKGROUND

[0002] Bougies have many uses in medicine, but are commonly used to dilate a passageway or to guide another instrument into a passageway. Endotracheal tube insertion aids, commonly referred to as "gum elastic bougies," are very thin, solid or hollow, and are cylindrical in shape, made of rubber, plastic or another material, which a physician can insert into a body passageway. In the field of endotracheal tube insertion, bougies are frequently used as a guide to properly place an endotracheal tube. Bougies are also used to provide suction or oxygen delivery within a body passageway.

[0003] Bougies typically require a level of flexibility to easily guide the bougie into a body passageway, but the required flexibility makes it difficult to grasp the bougie. Devices have been designed to help guide a bougie endotracheal tube, i.e., guide the bougie, but these devices are still limited in allowing sufficient grasping of the bougie to properly guide the bougie into a body passageway during a procedure.

[0004] In many medical situations, endotracheal intubation is a critical procedure that is performed to secure a patient's airway. To marginally insert an endotracheal tube, a physician, nurse or other medical personnel will use a laryngoscope blade that is inserted down the patient's throat. The laryngoscope blade is primarily used to move the tongue and epiglottis out of the way to provide a clear view of the vocal cords. To avoid hypoxic brain injury to the patient, it is imperative that the endotracheal tube be properly inserted into the patient's trachea quickly. The task of endotracheal intubation becomes more challenging in emergency situations, i.e., for patients with respiratory distress and at high risk of asphyxiation.

[0005] In the operating room, it is common to give a patient 100% oxygen to breathe prior to induction of general anesthesia in an attempt to replace the nitrogen in the lungs with oxygen, a process known as pre-oxygenation, which serves to fill the lungs with oxygen, like an oxygen reservoir. When the patient is induced into general anesthesia, the patient's breathing is suspended and must rely on the oxygen stored in the lungs to provide the oxygen needed for the body's basal metabolic needs. Adequate pre-oxygenation is sufficient to fill the lungs with oxygen to give the physician more time to place the instrument into the airway and attempt endotracheal intubation.

[0006] Assessment of the patient's airway status allows the physician to gauge the difficulty that can be encountered in attempting to intubate the patient. Certain clinical features of the patient can predict the degree of difficulty in intubating the patient, such as a large neck, obesity, history of sleep apnea, small mouth opening, tight teeth, etc. are all indicators of difficult intubation. Once the patient is deemed to have a difficult airway, the physician can resort to other devices to assist, such as a video laryngoscope, or an intubating adjunct such as a stylet. For patients with a difficult glottic airway, the physician can have a poor view of the vocal cords under direct laryngoscopy, which can make intubation difficult. A stylet is a key tool for a difficult airway because it has a curved tip that facilitates its passage into the patient's trachea.

[0007] It is common in the hospital setting to have a suction tube with an attached handle, also known as a Yankauer, which is used to suction fluid from the patient's airway. The Yankauer suction tube provides a direct view of the vocal cords under direct laryngoscopy. In an effort to overcome these problems, medical personnel often insert the Yankauer suction tube to remove blood, oral secretions, or gastric contents before the tracheal tube is properly placed. After the fluid is suctioned from within the laryngopharynx, the suction device must be removed and then the tracheal tube must be inserted into the trachea. This two-step procedure, i.e., first removing the secretions, gastric contents, or blood via the suction tube and then grasping the tracheal tube, results in a loss of time. However, these prior art procedures (along with the patient's oxygen reserves, switching between multiple devices) take valuable time. In addition, even while the suction tube is inserted into the mouth, fluid can re-accumulate between the time the suction tube is removed and the tracheal tube is inserted.

[0008] If the attempt at intubation fails, a balloon and mask device must be employed to assist the patient in breathing, which is capable of forcing air down the trachea and also down the esophagus. When the stomach is full of air, the patient becomes prone to vomiting and aspiration. The distended abdomen also decreases the patient's lung compliance, increasing the difficulty of breathing. In addition, repeated attempts at intubation with a laryngoscope blade involve placing instruments into the airway, which results in trauma to the patient, causing local bleeding and edema. Therefore, it is critical that the tracheal tube be quickly, accurately, atraumatically, and consistently placed on the first attempt at intubation. Repeated attempts at intubation often make the intubation more challenging. Abdominal distension, bleeding, or edema from balloon mask breathing can obstruct the physician's view of the vocal cords, leaving the patient at risk for aspiration. For patients with a difficult airway, a common problem under current intubation procedures is the time-consuming back-and-forth use of a stylet, Yankauer suction tube, and tracheal tube. This loss of time leaves the patient at risk for aspiration pneumonia, aspiration non-infective pneumonia, or hypoxic brain injury. SUMMARY

[0009] The present invention provides a grasping device for use in grasping a solid or hollow bougie during a tracheal intubation procedure. The grasping device has a curved channel that allows the grasping device to receive a bougie. Once the bougie is nested in the channel, the device also has a locking mechanism that allows the grasping device to securely hold the bougie in the channel while still allowing the bougie to slide within the channel. The combination of the extended curved channel and the locking mechanism will more securely grasp the bougie and allow the user to more easily insert the bougie into the patient's trachea.

[0010] Preferably, the locking mechanism is in the form of a locking ring.

[0011] The present invention also provides a method for tracheal intubation of a patient in which a bougie is inserted into the patient's airway with the aid of a grasping device. This grasping device securely locks the bougie in place while allowing the bougie to be adjusted inwardly or outwardly of the airway.

[0012] The present invention can also include a suctioning bougie that can be used to suction fluids and a tracheal intubation guiding member that can be used to insert a tracheal tube into the patient's airway. The hollow bougie can be connected to an external conduit such as a suctioning conduit or an oxygen delivery conduit.

[0013] Typically, when a medical professional uses a direct laryngoscope to see the vocal cords in the patient's airway, it is undesirable to have oral secretions, blood, large pieces of material or gastric contents present.

[0014] The airway devices mentioned above are primarily used for patients who have airway difficulties or are at risk of aspirating gastric contents. Treating such patients typically requires a tracheal intubation guiding member (commonly referred to in the art as a "bougie") in addition to an oral suctioning device. When the vocal cords are difficult to see, a bougie can be used and a suctioning device is required to clear the oral secretions or gastric contents to provide an unobstructed view of the vocal cords. Using either the bougie or the suctioning device requires the medical professional to handle either device back and forth. The present invention allows the medical professional to use both the bougie and the suctioning device simultaneously without having to spend time switching devices. This ultimately eliminates the inherent time delay in ensuring airway patency.

[0015] As mentioned above, the present invention is used as a device that is attached to a bougie to aid in tracheal intubation. The device can be attached to an existing bougie style tracheal intubation assisting member or to a suctioning bougie that is designed as a hollow tube. The suctioning bougie can include an elongated body that is hollow at both the proximal and distal ends. The distal end of the tube can have several open ports to allow oral secretions, blood or gastric contents to pass through. The proximal end is connected to a suctioning port.

[0016] The body of the bougie device can be made of Teflon, Polytetrafluoroethylene or plastic polymer, thus forming a self-lubricating device. This reduces the need for the bougie device to be lubricated for insertion into the patient's airway.

[0017] The present invention is designed with a curved handle that has a support channel to receive a solid or hollow bougie. Preferably, the handle will be generally rigid and will preferably be made of hard plastic.

[0018] The proximal end of the handle comprises a hollow tube that is attached at one end to the proximal end of the suction or oxygen bougie. The handle is designed with a recess, which means that under external force, i.e. the gripping force of the user's fingers, the bougie stays in the recess, which also presses the bougie into the curve of the recess, thus making the bougie more stable during intubation by increasing the gripping area.

[0019] After attaching the bougie to the proximal end of the handle, the bougie is then curved around itself so that its distal end is nested in the curved handle. The other end of the hollow tube of the proximal end of the handle is connected to a suction or oxygen tube that is common in hospitals or operating theatres.

[0020] There can be a vent port on the hollow tube that will allow suction from the distal tip of the suction bougie when the medical practitioner's fingers are blocking it. When the vent port is not blocked, the tip of the suction bougie will not create suction. The vent port allows the medical practitioner to have full control over when to use the suction function. A suction device that lacks this full control can result in continuous suction of oxygen from the patient's throat, which can subsequently result in hypoxia. The present invention can also be used for an oxygen delivery device.

[0021] The present invention also allows the intubation cuff to be placed over the bougie before the bougie is inserted into the patient's trachea. The intubation cuff can then be inserted into the trachea under the guidance of the bougie.

[0022] The device can be used with existing bougies to provide a more ergonomic way of using the bougie. Normally, the medical practitioner manipulates the bougie to introduce a curve to fit the intubation, which means that the curve of the bougie is in line with the natural curvature of the patient's throat. However, a common problem with the use of bougies is that it is difficult to direct the bougie into the patient's throat. The physical properties of the bougie make it thin and flexible, which makes it difficult for the medical practitioner to control the bougie. The device is designed with a curved channel into which the bougie is placed, and once the bougie is nested in the device, a locking ring secures the bougie to the device. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1A is a perspective view of a gripping device according to the present invention, comprising a bougie attached to a handle with a locking ring;

[0024] Figure 1B With Figure 1A the same, now showing the user holding the handle;

[0025] Figure 2 is a front perspective view of a first embodiment of the grip device of the present invention;

[0026] Figure 3 is a rear perspective view of the device of Figure 2 ;

[0027] Figure 4 is a side view of the device shown in Figure 2 , now showing the absence of the locking ring;

[0028] Figure 5 is a bottom perspective view of the device of Figure 4 ;

[0029] Figure 6 shows an end view of the locking ring of the present invention showing the angle Θ of the locking ring;

[0030] Figure 7 is a side perspective view of the device of Figure 6 ;

[0031] Figure 8 is a view of another embodiment of the locking ring of the present invention;

[0032] Figure 9 is another view of the embodiment shown in Figure 8 ;

[0033] Figure 10 is a front view of the grip device of the present invention;

[0034] Figure 11 is a close-up view of the locking ring in the open position in Figure 10 ;

[0035] Figure 12 is a close-up view of the locking ring in the locked position in Figure 10 ;

[0036] Figure 13 is a perspective view of the grip device according to the present invention, now showing the release valve;

[0037] Figure 14 is a front perspective view of the handle and the locking ring;

[0038] Figure 15 is a rear perspective view of the handle and the locking ring;

[0039] Figures 16-18 shows the handle at the same time as the locking ring is mounted from a different angle;

[0040] Figures 19-20An alternative embodiment is shown in which the locking ring is used below the handle rather than on the handle.

[0041] Figure 21 Another embodiment of the present application is shown;

[0042] Figure 22 is an elevational view of an embodiment of the present application; and

[0043] Figure 23 is a cross-sectional view of an embodiment of the present application taken from Figure 22 the line DETAILED DESCRIPTION

[0044] As will be seen, the present application overcomes many of the problems associated with the prior art, namely, difficulty in endotracheal intubation with a difficult airway, high risk of aspiration or emergency tracheal intubation. During general anesthesia induction, comatose patients or certain medical conditions can place the patient at risk for aspiration of gastric contents. Certain conditions, such as morbid obesity, diabetic gastroparesis, pregnancy, hiatal hernia, and a full stomach, increase the risk of aspiration during induction of general anesthesia. The present application allows the operator to clear the field of view of the operator of oral secretions, gastric contents, and blood in order to perform a safe endotracheal intubation of the patient.

[0045] Figure 1A depicts a bougie handle 10 in accordance with the present application, Figure 1B depicts the handle in use. The handle 10 encloses a bougie 12 and a locking ring 14 is provided to secure the bougie 12 in the handle 10. As will be discussed in further detail below, the locking ring allows the bougie 12 to be securely seated and locked in place, but still allows the bougie to slide in or out depending on the patient's airway during intubation of the patient's trachea. The handle 10 has a top end, a bottom end, and a plurality of gripping ridges, as shown in Figure 1B which allows for one-handed operation, i.e., by turning the locking ring with the thumb or middle finger.

[0046] Referring to Figure 2 , the handle 10 further has a flexible stop tab 16, a bougie support channel 18, and a bougie channel retainer 20. The bougie 12 has a proximal end 22 and a proximal end opening 24. The bougie 12 also has a distal end inlet 26 and outlet 28. Figure 1 also shows the device for endotracheal intubation, which includes a tracheal tube cuff 30 and a tube 32. Figure 1A and Figure 1B An elbow segment 46 is also shown for connecting the handle 10 to the inlet / outlet 26 / 28.

[0047] Turning to Figure 4 and Figure 5The handle 10 can be seen without the associated locking ring 14, while showing the handle 10 with the reduced diameter section 34 for retaining the locking ring 14 and allowing the locking ring 14 to rotate. In these figures, the flexible tab 16 can be clearly seen. Referring to Figure 4 and Figure 5 the handle 10 is shown without the associated locking ring 14.

[0048] Figures 6-9 The locking ring 14 is shown from several views in

[0049] At least a first leading finger member 40 and a plurality of additional finger members 42 are spaced around the circumference of the locking ring 14. As shown in Figure 1B these allow the user to manipulate the locking ring 14 around the section 34 using finger / thumb pressure.

[0050] Figure 6 is an end view of the locking ring 14 showing the angle Θ formed by the intersection of lines extending from the leading finger member 40 and the member 42 adjacent the opening 36. The angle can be any effective angle that allows the locking ring 14 to be able to snap onto and be retained by the section 34. For the same purpose, the opening 36 is sized to be complementary to the diameter of the surface 38.

[0051] As shown for example in Figure 7 the locking ring 14 features a collar 52 extending at each end. The enlarged ring end 40 is followed by the collar 52, while the finger members 42 do not extend as far as the collar 52. The collar 52 sits below and is held below the tab 16, and is also held by being shaped to fit the reduced diameter section 34.

[0052] Figures 6-8 It is also shown that there is at least one stop rib 44, which has a ramp 44A and a stop face 44B. As shown in Figure 9 two stop ribs 44 can be provided. Additional stop ribs 44 can also be provided if desired.

[0053] Turning now to Figures 10-12 the locking ring 14 can be rotated from an open position ( Figure 11 ) in which the stop rib 44 is positioned with its stop face 44B abutting the tab 16, to a locked position ( Figure 12), the loop end 40 is positioned so that its loop end 40B abuts the tab 16. In this manner, the lock ring 14 can be turned by a finger or thumb to an open position so that the bougie 12 can be inserted into or removed from the handle 10, or the lock ring 14 can be turned to a closed position to prevent the bougie 12 from moving during the intubation procedure. Figure 22 and Figure 23 Further showing the relationship of the components to each other.

[0054] Returning to Figure 2 and Figure 3 , the handle 10 is shown without the bougie 12. This allows the recess 13 to be shown. It can be seen that the channel 18 is curved to form and support the particular bend of the endotracheal tube. In other words, with the curved channel 18, the bougie 12 will maintain a curved shape during the procedure, and such a curve helps in the insertion of the bougie 12 during the procedure.

[0055] Figure 13 An alternative embodiment is shown in which a finger valve 50 is provided for manual ventilation. Figure 14 and Figure 15 The handle 10, lock ring 14, tab 16, support channel 18, channel retainer 20, leading finger member 40, gripping surface 48, and collar 52 are shown.

[0056] Figure 14 and Figure 15 An alternative embodiment is shown in which the elbow segment 46 is not provided. This embodiment is useful for placing the bougie when the inlet 26, outlet 28, or valve 50 are not needed.

[0057] Turning now to Figures 16-18 , the lock ring is initially mounted to the handle. The lock ring opening 36 is facing the reduced diameter lock ring support segment 34, and it is inserted until the leading finger member 40 is secured in close proximity to the tab 16, and the surface 38 is in sliding contact with the segment 34.

[0058] As shown in Figure 15 , it is advantageous for the user to be able to adjust the lock ring 14 with one hand, particularly the same hand that is holding the handle 10. The present invention and the arrangement of the lock ring 14 improve upon the prior art to provide a more efficient endotracheal tube insertion method as compared to the prior art. By locking the bougie 12 in the channel 18, the user can reposition the handle 10 and / or the bougie 12 without having to separate the handle 10 from the bougie 12. Moreover, the device allows the bougie 12 to slide within the device without the worry that the bougie 12 will accidentally come out of the channel.

[0059] It is contemplated that the reduced diameter section 34 will be placed centrally on the handle 10 for easy finger / thumb control. However, Figures 19-20 An embodiment of the handle 10 is shown in which the gripping region 48 is provided separately from the locking collar 14, i.e. at the section 34, below the gripping region 48. In this embodiment, a retainer 35 is provided to hold the locking collar 14 in place.

[0060] Figure 21 A bougie handle 10 and a bougie 12 are shown. The bougie 12 sits in a recess 13 (not shown) extending from the handle 10 through to the curved support channel 18 and is held in place by the channel retainer 20 and the locking collar 14. The locking collar 14 is seen in contact with the tab 16 at the reduced diameter section 34. The member 40 is shown adjacent the tab 16 and at least one loop 52 can be seen. The elbow section 46 connects the gripping section 48 with the inlet / outlet 26 / 28.

[0061] The foregoing description merely explains the principles of the application. Furthermore, it is not intended that the application be limited to the exact structure and operation described herein, as modifications and variations are possible and intended to be within the scope of the application. Although preferred embodiments have been described, it will be apparent to those skilled in the art that changes and modifications can be made that will alter this specific implementation, while still being within the spirit of the application as defined by the following claims.

Claims

1. A device for gripping a probe, the device comprising: A grip, which has a groove therein; Lock ring; as well as A longitudinally curved support channel extending from the groove; The probe is fixed within the groove by the locking ring. The handle has at least one stop tab. Furthermore, the locking ring has at least one stop ridge, the stop ridge having at least one inclined surface and at least one stop face, wherein the stop face prevents the locking ring from moving past the stop tab, and wherein the inclined surface allows the locking ring to move below and past the stop tab.

2. The apparatus according to claim 1, wherein, The locking ring is rotatable around the handle to secure the probe in the groove.

3. The apparatus according to claim 1, wherein, The handle has a reduced diameter portion, and the locking ring is sized to fit onto the reduced diameter portion.

4. The apparatus according to claim 3, wherein, The portion with the reduced diameter is located approximately in the center of the handle.

5. The apparatus according to claim 3, wherein, The stop plate restricts the rotational capability of the locking ring.

6. The apparatus according to claim 5, wherein, The stop piece is flexible.

7. The apparatus according to claim 1, wherein, The locking ring has two ends, and at one of the ends, the locking ring supports at least one loop extension.

8. The apparatus according to claim 7, wherein, The locking ring is supported by a ring extension at each of its two ends.

9. The apparatus according to claim 1, wherein, The locking ring has an opening for allowing the locking ring to be mounted on the handle, wherein the opening is adjacent to a finger member on each side, wherein the finger member forms a partial V shape.

10. The apparatus according to claim 9, wherein, The opening is smaller than the diameter of the handle.

11. A device for gripping a probe, the device comprising: A grip having a top end, a bottom end, an inner surface forming a side opening, and an outer surface, wherein the grip has at least one stop tab. A locking ring having at least one stop ridge, the stop ridge having at least one bevel and at least one stop surface, wherein the stop surface prevents the locking ring from moving past the stop tab, and wherein the bevel allows the locking ring to move below and past the stop tab. The outer surface includes a gripping area, which is positioned relative to the side opening.

12. The apparatus according to claim 11, wherein, The gripping area includes multiple ridges.

13. The apparatus according to claim 11, wherein, The device has an inlet and an outlet at its top.

14. The apparatus of claim 11, further comprising a support channel having a channel recess therein, wherein, The support channel extends from the groove, and wherein the support channel is longitudinally curved.

15. The apparatus according to claim 14, wherein, The support channel supports a tube retainer.

16. The device of claim 14, further comprising a single-slot valve located on the handle.

17. The apparatus according to claim 14, wherein, The bottom end of the grip has a section with a reduced diameter and at least one stop tab.

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