CROSS REFERENCE TO RELATED APPLICATIONS

This application is a national stage filing under 35 U.S.C. § 371 of International Patent Application No.: PCT/SG2018/050470, filed Sep. 13, 2018, which claims priority to Singapore Patent Application No. 10201707514T, filed Sep. 13, 2017, the entire contents of all of which are hereby incorporated by reference herein.

FIELD OF INVENTION

The present invention relates broadly to method and devices for incision and insertion of a ventilation tube.

BACKGROUND

Any mention and/or discussion of prior art throughout the specification should not be considered, in any way, as an admission that this prior art is well known or forms part of common general knowledge in the field.

Otitis media with effusion (OME) is a very common ear disease that causes body imbalance, discomfort and may even result in irreversible damage to the middle ear structure. When medication as a treatment for OME fails, a ventilation tube (VT, or grommet) is surgically inserted on the tympanic membrane (TM) so that the accumulated fluid can be drained out. The procedure is called “myringotomy with tube insertion”. It starts by performing a myringotomy, which involves making a small incision on the TM, and then inserting a VT into the incision. This surgery can be performed under local anaesthesia (LA) in adults if they can tolerate the discomfort, but the usual practice for young children is to use general anaesthesia (GA) as the pain tolerance level of young children is very low. Approximately 90% of children have OME at some time before school age, and the insertion of VT is one of the most common paediatric surgeries performed, and the most common reason for a child to undergo a GA. Studies have shown that there are long term health effects from GA, including possible delay in brain development of children. Hence there is a need to research on ways to avoid GA during myringotomy and VT insertion. One possible way is to shorten the duration of the incision and VT insertion procedures such that it is over in a blink of an eye and the child only has to be still for a short while. In this case, a mild sedation or local anaesthesia may preferably be sufficient.

There have been several developments that aim to do achieve that goal, by combining the 2-step procedures into a single step. This can eliminate the need to change tool sets hence shorten the duration. Two such examples are the “Insertion System for Deploying a Ventilation Device” by Perceptis Medical Inc (US 2013/0338678) and the “Tympanic Membrane Pressure Equalization Tube Delivery System” by Acclarent Inc (US 2015/0164695). Both systems utilise a cutting sheath or cutting member to incise the TM and a deformable VT that is preloaded within the sheath or shaft such that when the VT is inserted into the incision, and the shield or sheath that is holding the VT is released, the distal flange of the deformable VT opens up and assumes an expanded configuration. In both systems, the deformable VT is custom made by the respective companies. This means that users of the systems have to use the companies specific VTs, and would be constrained to the specific VT's shape, size and material. This is undesirable as different patients require different VTs according to their age and the severity of OME.

In light of the above, it would be desirable to provide an alternative device that not only provides a system that facilitates the VT insertion without requiring a 2-step process or multiple tool set changes, but would also allow the use of commercially available VTs of differing sizes and shapes. Also, for neonate and infants, the TM is in an extremely oblique position, whereas for adults, the TM angles range from 45 degrees to 60 degrees. Hence, it would be desirable for the system to be able to cater to a wide-range of TM angles.

Embodiments of the present invention seek to address at least one of the above needs.

SUMMARY

In accordance with a first aspect of the present invention, there is provided a device for incision and insertion of a ventilation tube, the device comprising a cutter member configured to make an incision; a holder member configured to dispose the ventilation tube in an orientation in which a longitudinal axis of the ventilation tube is substantially perpendicular to the cutter element; and a pusher member configured to apply a pushing force to a first end of the ventilation tube in a direction substantially perpendicular to the longitudinal axis, the first end of the ventilation tube being disposed closer to the blade than a second end of the ventilation tube; wherein the holder member comprises a pivot element configured to releasably engage the second end of the ventilation tube such that the ventilation tube is pivotable about the pivot element under the pushing force applied to the first end of the ventilation tube by the pusher member, for insertion of the first end of the ventilation tube into the incision.

In accordance with a second aspect of the present invention, there is provided use of the device of the first aspect in making an incision and inserting a ventilation tube in a membrane.

In accordance with a third aspect of the present invention, there is provided a method for making and incision and inserting a ventilation tube in a membrane, the method comprising the steps of making an incision using a cutter member; disposing the ventilation tube in an orientation in which a longitudinal axis of the ventilation tube is substantially perpendicular to the cutter element using a holder member coupled to the cutter member; applying a pushing force to a first end of the ventilation tube in a direction substantially perpendicular to the longitudinal axis, the first end of the ventilation tube being disposed closer to the blade than a second end of the ventilation tube, using a pusher element coupled to the cutter member and the holder member; releasably engaging the second end of the ventilation tube using a pivot element of the holder element; and pivoting the ventilation tube about the pivot element using the pushing force applied to the first end of the ventilation tube by the pusher member, for inserting the first end of the ventilation tube into the incision.

