GB2454018A

GB2454018A - Introducer device for bougie tube

Info

Publication number: GB2454018A
Application number: GB0721122A
Authority: GB
Inventors: Dr David W Green; Stuart Wallace
Original assignee: Individual
Current assignee: Individual
Priority date: 2007-10-26
Filing date: 2007-10-26
Publication date: 2009-04-29
Also published as: GB0721122D0

Abstract

The present invention relates to an introducer device e.g. laryngoscope, for insertion into a patient's mouth for use with a bougie tube. The device comprises an elongate insertion member (100), having a maximum width of 5mm-1Omm, which has a guide member for guiding a bougie tube. In another aspect the system comprises a plurality of insertion members and a releasable handle.

Description

INTRODUCER

[001] The present invention relates to an introducer device for insertion into a patient's mouth for use with a bougie tube, and the like.

[002] In the medical field, devices are known for

introduction into a patient's mouth during anaesthesia and surgery to secure the airway to the lungs and allow oxygen levels in the lungs to be regulated. It is known to use a laryngoscope, as shown in Figure 1, to be inserted into the mouth to initially open the airway by lifting the base of the patient's tongue to expose the larynx, vocal cords and trachea. The laryngoscope is used in combination with an endotracheal tube, which is passed through the laryngoscope and into the patient's trachea for oxygen provision. The endotracheal tube passes into the trachea via the larynx and vocal cords. This technique is called endotracheal intubation.

[003] The laryngoscope itself is generally formed of a blade portion 10 to be inserted into the body and a handle portion 20 to remain outside the body. The laryngoscope is often provided with optical elements provided between the distal end of the blade and a viewing portion in the handle end to allow, in use, vision of the larynx, vocal cords and trachea. The optical elements may be a series of lenses and mirrors or may. include an optical fibre. There may also be a light source to increase visibility. This requires a battery pack 30 to be located in the handle portion. Upon locating the larynx, vocal cords and trachea using the optical elements, the endotracheal tube can be advanced through the larynx and vocal cords into the trachea. An example of such a laryngoscope is described in US 6,843,769.

[004] Also in the medical field, bougie tubes are known for use in various operations in which the trachea is entered via the mouth. The tube is often used in endotracheal iritubatjon.

[005] Since bougie tubes are smaller in diameter than endotracheal tubes, they can also be used for "rail roading" of endotracheal tubes, in situations where the endotracheal tube is proving difficult to place. That is, the bougie tube is first inserted into the trachea, and then the endotracheal tube is rail-roaded over the top of the bougie tube.

[006] Presently, the above mentioned laryngoscope is also often used in conjunction with a bougie tube for use in placement of the bougie tube in relation to the larynx and vocal cords.

[007] Problems with conventional laryngoscopes arise from their design for use with conventional endotracheal tubes.

As such, they are constrained to having relatively large external dimensions. This, along with differing patient anatomies can lead to problems with correct insertion, and the potential for damaged teeth and gums if the laryngoscope is inserted without precision or if the mouth is not adequately open. Such problems are compounded where the laryngoscope is configured to have lighting/viewing facilities, further enlarging its external dimensions.

[008] It is an object of the present invention to overcome or mitigate the above problems.

[009] According to a first aspect of the present invention there is provided an introducer device for insertion into a patient's mouth, the device comprising an elongate insertion member, the insertion member having a guide member for guiding a bougie tube, wherein the insertion member has a maximum width dimension of 5 mm to 10 mm.

[0010] To date, this invention is the first device proposed specifically for use with a bougie tube. The specific dimensions mean that the device is narrower, less invasive, cheaper and more easily maneuverable compared to using a laryngoscope which is traditionally used for guiding a bougie tube. Furthermore, the small dimensions pose less of a risk in causing teeth damage/breakage and/or other trauma to patients, and require reduced amount of mouth opening by the patient. In this regard, the maximum width of the device is its maximum dimension transverse to the longitudinal axis of the insertion member.

[0011] Conveniently, the guide member is a channel provided along the length of the insertion member. In this regard, the bougie tube can be simply fed along the channel, thereby following the insertion member.

[0012] Conveniently, the channel is open along one side thereof such that a bougie tube may be guided along the channel for insertion, but can be withdrawn sideways from the channel when necessary.

[0013] Conveniently, the insertion member has a maximum width of 5 mm to 7 mm. Such dimensions provide for an enhanced apparatus in terms of ease of insertion and risk of patient injury compared with known laryngoscopes.

[0014] Conveniently, the introducer device further comprises a handle at the proximal end of the device and wherein the handle is detachable from the insertion member. In this respect, the insertion member, otherwise termed the blade, may be readily removable following a procedure, and replaced with a new, sterile insertion member.

[0015] Conveniently, the insertion member is formed of an illuminable material. The material may be plastic. With this material, the insertion member can be completely illuminated by a connecting light source, and itself used as a light. This will assist a user in placing the insertion member into the patient's mouth correctly.

[0016] Conveniently, the introducer device further comprises a light source in the handle. The illuminable insertion member can be connected thereto.

[0017] Conveniently, the light source is an LED light source. Currently available LED light sources can be very powerful, yet have very low power consumption, for example giving up to 50 hours of continuous use with just 3 AAA batteries.

[0018] Conveniently, the introducer device further comprises a flange extending from the distal end of the insertion member for lifting the epiglottis.

[0019] According to a second aspect of the present invention there is provided an introducer device system, the system comprising: -a plurality of insertion members for insertion into a patient's mouth; and a handle releasably connectable to a chosen one of said plurality of insertion members to form said introducer device.

[0020] Conveniently, one or more of the abovementioned insertion members may have a maximum width dimension of 5 mm to 10 mm.

[0021] With such a system, the insertion members can be made of disposable material, while the handle can be made to be reusable. This allows substantial cost savings.

[0022] Conveniently, one or more of the insertion members is a disposable item.

[0023] Conveniently, the one or more insertion members may be formed of plastic material. In particular, it may be illuminable plastic material.

[0024] The present invention moreover encompasses an insertion member for use in the system defined above.

[0025] According to a third aspect of the present invention there is provided a method of introducing an endotracheal tube into an.orifice, the method comprising:-inserting an introducer device comprising an insertion member having a maximum width dimension of 5 mm to mm into the orifice; inserting a bougie tube into the orifice by coupling the bougie tube to the insertion member and using the insertion member as a guide; decoupling the bougie tube and the insertion member and removing the insertion member from the orifice; passing the endotracheal tube over the bougie tube and running it down the bougie tube, using the bougie tube as an internal guide; and removing the bougie tube to leave the endotracheal tube in the correct position.

[0026] According to a fourth aspect of the present invention there is provided an introducer device for insertion into a patient's mouth, the device comprising an elongate insertion member, the insertion member having a guide member for guiding a bougie tube and being formed of an illuminable material. Since the insertion member is capable of being lit, there is no need for a separate optical channel as in the prior art devices. The device will again have the advantages mentioned above of being narrower (a separate light channel is not required), less invasive, cheaper and more easily maneuverable compared to using a laryngoscope.

[0027] Examples of the present invention will now be described with reference to the accompanying drawings, in which: [0028] Figure 1 shows a laryngoscope of the prior art [0029] Figure 2 shows a cross section along the line X-X of Figure 1; [0030] Figure 3 shows shows an introducer device of an embodiment of the present invention; [0031] Figure 4 shows a cross section along the line Y-Y of Figure 3; [0032] Figure 5 shows a further embodiment of the present invention; and [0033] Figure 6 shows an expanded view of part of Figure 5 (0034] Figure 3 shows an embodiment of an introducer device of the present invention. It includes an insertion member (blade) 100 for insertion into a patient's mouth and throat.

The blade is tubular in shape, the channel being of a size to allow a bougie tube to be inserted along the blade. The introducer is open at both ends. With such a configuration, in use, the blade is inserted into the throat, and then the bougie tube can be guided by the introducer and positioned in its desired position.

[0035] The introducer also has a handle 120 connected to the blade, which remains outside of the body. The handle allows a user, for example an anaesthetist, to steer the introducer in its desired location.

[0036] Figure 4 shows a cross section of an example of the blade 100 (not to scale). The blade shown in Figure 4 is almost circular in cross section. It is open along one side thereof such that a bougie tube can be guided along the channel within the blade upon insertion, but can be withdrawn sideways from the channel if necessary.

[0037] The maximum overall diameter of the blade is between mm and 10 nun. In the case of the embodiment shown in Figures 3 and 4, the channel needs to be just marginally larger than the size of a bougie tube (which is around 5 mm in diameter).

[0038] In the present embodiment, the blade is made of an illuminable plastic material. Thus the material is capable of transmitting light and also being illuminated itself along its length. In the handle 120, there is a powerful LED light source 110. The light source 110 is capable of illuminating the whole blade so that the whole blade acts as a light source. In use, with this arrangement, the entire blade is illuminated and enables excellent viewing and locating capabilities. Since positioning of the blade must be very precise, the illuminated blade is particularly useful for checking location of the larynx, epiglottis, oesophagus and trachea.

[0039] To further improve the locating of the blade, a flange 130 is provided at the distal end of the blade. The flange 130 allows a patient's epiglottis to be lifted out of the way for easier access to the larynx.

[0040] In another embodiment of the present invention, the blade is formed to be detachable from the handle. This is shown in Figures 5 and 6. The handle has projections 150 on opposite sides thereof, which locate and clip into corresponding apertures in the blade 100 provided to receiving the projections. In this embodiment, the blade is formed of a plastic material of sufficient rigidity and durability for use in a patient's mouth with a bougie tube being inserted therethrough. The blade can be formed of a metal but this would be a more expensive option. The relatively flexible nature of the plastic blade allows it to be gently maneuvered to receive the projections 150 in the handle.

[0041] The handle portion of the device remains outside the patient's body and can therefore be reused many times with different blades. Reuse of the handle with disposable blades therefore affords significant cost savings.

[0042] In addition to the above mentioned applications of the present invention, the device can also be used for bougie tube placement in providing oxygen/gas to the trachea, placement in monitoring gas levels in the trachea/oesophagus, providing anaesthetic to the larynx/trachea or sucking out secretions or air from within the stomach. The present invention can be used in a rail roading" technique, for oral-tracheal tube placement, when, due to the larger size of oral-tracheal tubes, positioning is more difficult. The device of the present invention is first inserted into a patient, the bougie tube is then inserted through the device, the device is removed from the patient, and then the oral-tracheal tube is "rail roaded" over the top of the bougie tube. The device may similarly be used for the placement of a naso-gastric tube. Different lengths of blade may be provided for such different uses. For all of these applications, the relative size of the present device gives advantages to the patient in terms of trauma level and to the user in terms of ease of use and precise placement.

[0043] Furthermore, it will be realized that the present invention may equally have other configurations to that described. In particular, the insertion member need not be generally of circular cross-section, but may be an elongate guide of any suitable shape or cross-section, with a guide member connected thereto. For example, it may be a rod-like member with a guide member provided just at the distal end thereof.

Claims

-10 - CLAIMS

1. An introducer device for insertion into a patient's mouth, the device comprising an elongate insertion member, the insertion member having a guide member for guiding a bougie tube, wherein the insertion member has a maximum width dimension of 5 mm to 10 mm.

2. An introducer device according to claim 1, wherein the guide member is a channel provided along the length of the insertion member.

3. An introducer device according to claim 2, wherein the channel is open along one side thereof.

4. An introducer device according to claim 1, 2 or 3, wherein the insertion member has a maximum width of 5 mm to 7 mm.

5. An introducer device according to any preceding claim, further comprising a handle at the proximal end of the device and wherein the handle is detachable from the insertion member.

6. An introducer device according to any preceding claim, wherein the insertion member is formed of an illuminable material.

7. An introducer device according to claim 6, wherein the insertion member is formed of plastic.

8. An introducer device according to claim 6 or 7 when dependent on claim 5, further comprising a light source in the handle.

-11 -

9. An introducer device according to claim 8, wherein the light source is an LED light source.

10. An introducer device according to any preceding claim, further comprising a flange extending from the distal end of the insertion member.

11. An introducer device system, the system comprising:-a plurality of insertion members for insertion into a patient's mouth; and a handle releasably connectable to a chosen one of said plurality of insertion members to form said introducer device.

12. An introducer device system according to claim 11, wherein the handle has a battery for powering an optical component of the introducer device.

13. An introducer device system according to claim 11 or 12, wherein at least one insertion member has a maximum width dimension of 5 mm to 10 mm.

14. An introducer device system according to any one of claims 11 to 13, wherein at least one insertion member is disposable.

15. An introducer device system according to any of claims 11 to 14, wherein at least one insertion member is formed of plastic material.

16. An introducer device system according to any of claims 11 to 15, wherein at least one insertion member comprises a light source and the light source may be connected to a battery source contained within a connectable handle.

-12 -

17. An insertion member for use in the introducer device system according to any one of claims 11 to 16.

18. A method of introducing an endotracheal tube into an orifice, the method comprising:-inserting an introducer device comprising an insertion member having a maximum width dimension of 5 mm to mm into the orifice; inserting a bougie tube into the orifice by coupling the bougie tube to the insertion member and using the insertion member as a guide; decoupling the bougie tube and the insertion member and removing the insertion member from the orifice; passing the endotracheal tube over the bougie tube and running it down the bougie tube, using the bougie tube as an internal guide; and removing the bougie tube to leave the endotracheal tube in the correct position.

19. An introducer device for insertion into a patient's mouth, the device comprising an elongate insertion member, the insertion member having a guide member for guiding a bougie tube and being formed of an illuminable material.

20. An introducer device substantially as herein described with reference to Figures 3-6.

21. An insertion member substantially as herein described with reference to Figures 3-6.

22. An introducer device system substantially as herein described with reference to Figures 3-6.