Apparatus and method as preparation for performing a...

Surgery – Endoscope – With tool carried on endoscope or auxillary channel therefore

Reexamination Certificate

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Details

C606S013000, C606S017000, C600S200000

Reexamination Certificate

active

06475138

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to laser devices and biomedical applications thereof. More specifically, the invention relates to setting-up a laser-based system in preparation for performing a myringotomy in an ear without the need for anaesthesia.
BACKGROUND OF THE INVENTION
Myringotomy is a widely-performed procedure used in the treatment of “Otitis Media”-acute inflammation of the middle ear. Typically, it involves a surgical procedure whereby the surgeon performs a tiny incision of the eardrum in order to enable the drainage of fluids that accumulate in the eardrum. The incision in the eardrum must remain open and thus an open drainage ring is placed in the incision to prevent rapid healing and occlusion of the incision. This surgery is done under general anaesthesia.
Over the last few years surgeons performed myringotomy surgery using a pulsed CO
2
laser. The advantage of the pulsed CO
2
laser is its generation of thermal heat resulting in delayed healing of the incision of the eardrum. The incision remains open for approximately 3-6 weeks without the aid of an open drainage ring. Both the incision diameter and laser pulse time duration affect the incision healing time. Typically, the incision diameter is approximately 1 mm and the laser pulse time duration is 0.1 second at a 3-5 Watt power. This surgical technique is generally performed under anaesthesia, because the surgery uses a “defocused” beam that does not account for a child's unexpected movement.
There is a need to perform the myringotomy procedure more accurately without the need for anaesthesia. Moreover, there is a need to perform the myringotomy on the tympanic membrane of the child's ear drum such that any sudden, unexpected movement of the child's head will not adversely affect the carrying out of the myringotomy. The present invention, as described as follows, provides such an improved myringotomy procedure in children without anaesthesia.
A common problem in systems having an optical imaging system for providing a focusable image of a target using while also providing a laser directing optical system for directing a surgical and or aiming laser beam at the same target is that the co-focusing action usually involves a system for coordinating the moving of at least some optical components of both the imaging optical system and the laser directing optical system. Such coordinated movement mechanisms are expensive, difficult to construct and maintain and may frequently become un-coordinated.
There is thus a need for hand held otoscope for myringotomy and other applications which has a simple optical system which does not require coordinated moving of different optical components while still enabling the user to focus an aiming laser beam and monitor the focusing and aiming action thereof on a display prior to activating the surgical laser beam. The present invention, as described as follows, provides an improved myringotomy device for use in performing myringotomy in children and adults without anesthesia.
SUMMARY OF THE INVENTION
One aspect of the invention relates to a method and apparatus suitable for carrying out laser surgery, such as for performing a myringotomy without the need for anaesthesia. The apparatus includes focusable imaging laser otoscope having a single focusing mechanism which enables focusing both the imaging optics and the laser focusing optics without requiring coordinated moving of the imaging optical components and the laser focusing optical components, enabling the user to focus an aiming laser beam and monitor the focusing and aiming action thereof on a display prior to activating the surgical laser beam.
Another aspect of the present invention is a sensor attached within the apparatus for sensing electromagnetic radiation emissions emanating from the target area in response to the surgical laser beam or the aiming laser beam striking the target area and for indicating the penetration of the target area.
Yet another aspect of the present invention is a system including a sensor attached within the apparatus, and a processing unit connected to the sensor and to the surgical laser. The sensor senses electromagnetic radiation emissions emanating from the target area in response to the surgical laser beam or the aiming laser beam striking the target area. The sensor produces a signal which is processed by the processing unit for automatically detecting the penetration of the target area. The processor unit controls the surgical laser and automatically stops the lasing of the surgical laser upon detecting the penetration of the target area.
There is therefore provided, in accordance with a preferred embodiment of the present invention, an apparatus for performing laser surgery without the need for anesthesia. The apparatus includes a housing, an end member movably disposed within the housing, an imaging device attached to the housing for producing an image of a target area, an illuminating system attached to the housing for illuminating the target area. The apparatus further includes a speculum having a longitudinal axis, a first end and a second end. The second end of the speculum detachably attached to the end member. The apparatus further includes an optical system attached to the housing and having a main optical axis coaxial with the longitudinal axis of the speculum, for directing a surgical and/or an aiming laser beam from a laser source through the housing and the speculum to strike the target area, and for directing image forming light rays to project an image of the target area onto the imaging device such that when the image of the target area is focused, the surgical laser beam and/or aiming laser beam are also focused on the target area. The apparatus further includes a focusing assembly attached to the housing and to the end member for adjustably moving the end member and the speculum relative to the housing to focus the image of the target area.
There is also provided, in accordance with a preferred embodiment of the present invention, an apparatus for performing laser surgery without the need for anesthesia. The apparatus includes a housing having an end, an imaging device attached to the housing for producing an image of a target area, an illuminating system attached to the housing for illuminating the target area. The apparatus also includes a speculum having a longitudinal axis, a first end and a second end. The second end of the speculum is detachably attached to the end of the housing. The apparatus also includes an optical system attached to the housing and having a main optical axis coaxial with the longitudinal axis of the speculum, for directing a surgical and/or an aiming laser beam from a laser source through the housing and the speculum to strike the target area and for directing image forming light rays to project an image of the target area onto the imaging device such that when the image of the target area is focused, the surgical laser beam and/or aiming laser beam are also focused on the target area.
Furthermore, in accordance with another preferred embodiment of the present invention, the speculum is exchangeable with any selected one of a plurality of specula, each one of the plurality of specula having different dimensions. The image of the target area is focused by selecting a suitable speculum out of the plurality of specula.
Furthermore, in accordance with another preferred embodiment of the present invention, the laser source is connected to the housing through a scanner for scanning the surgical laser beam and/or the aiming laser beam along a portion of the target area.
Furthermore, in accordance with another preferred embodiment of the r present invention, the scanner is a flashscanner or a silktouch scanner.
Furthermore, in accordance with another preferred embodiment of the present invention, the laser source includes a pulsed or a continuous laser.
Furthermore, in accordance with another preferred embodiment of the present invention, the laser source further includes an aiming laser.
Furthermor

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