Surgery – Instruments – Light application
Reexamination Certificate
2000-07-26
2002-09-24
Cohen, Lee (Department: 3739)
Surgery
Instruments
Light application
C606S013000, C606S014000
Reexamination Certificate
active
06454762
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to an instrument for applying light, particularly laser light, into the human or animal body, especially for endonasal laser surgery.
In the medical field relating to respiratory organs, patients must be frequently treated when respiration is hindered in the nose. The most common cause for respiratory problems in the nose are pathological enlargements in the upper, central and/or lower concha of the inner nose. The condition of pathologically enlarged concha is distinguished between hypertrophy and hyperplasia of the concha.
Hypertrophy is an increased concha volume resulting from the swelling of cells, which is caused by an allergy or is hereditary. It does not represent a true growth of tissue. The condition of hyperplasia is a cell multiplication initiated by the body, which is an actual cell tissue growth. The purpose of the treatment in both cases is to improve respiration by reducing the concha of the nose.
Various therapeutic methods have been developed in the background art. Conventional methods include diathermy, for example high frequency heat therapy or electro-coagulation, and conchotomy by which part of the concha is cut out with a mechanical cutting instrument.
With respect to diathermy, a disadvantage is that the depth of the heat treatment is difficult to control. In addition, large portions of the mucous membrane can be damaged. Further side effects can occur in the early post-operative phase, for example the feeling of illness and disturbed respiration.
Conchotomy has the disadvantages that the therapy must be carried out under full narcosis, that strong bleeding is caused and the use of tampons is necessary due to the danger of subsequent bleeding. In addition, conchotomy requires stationary treatment of four to seven days and a longer convalescence time. Furthermore, the danger of improper healing and infection exists.
The treatment of pathological tissue by means of laser light, which has been successful in other medical fields, is not hampered with the above-mentioned disadvantages. In contrast to the above conventional operation methods, a therapy with laser light allows a minimal invasive operation. The possible advantages of laser therapy of the concha have been reported in the German medical journal “HNO aktuell”, pages 223 to 230, 1997 in the article “Laser in der Rhinologie”. The actual use of laser therapy for treating the concha, however, has failed to date due to the lack of suitable instruments. The effect of laser light on tissue in general includes a coagulation, i.e. a heating, by which the tissue protein is denaturated, and an ablation and vaporization, by which tissue is removed or vaporized.
The effect depends on the distance from the waveguide tip to the tissue through which the applied energy density can be varied. The “contact method” and the “non-contact method” have become common. In the contact method, the waveguide tip contacts the tissue achieving a vaporizing, cutting effect. In the non-contact method, a defined spacing exists between the waveguide tip and the tissue to be treated, where an ablation or coagulation of the tissue takes place.
The advantages of laser therapy are numerous. The risk of bleeding is substantially reduced, the operation time is greatly shortened, no full narcosis is necessary but only a local narcosis and post-operative complications are extremely unlikely.
In using laser light therapy for reducing the lower concha, instruments are currently being used on a trial basis, which have become established in orthopedics for laser arthroscopy. These instruments consist of a simple, bent tube, which receives the light waveguide. The tube or tubular shaft is previously bent to an angle of up to 30° or is bent after insertion corresponding to the given anatomy of the patient.
These known instruments, however, have several drawbacks. When inserting the waveguide, the tip and especially the polished end surface where light emission takes place can be damaged when passing the bent section of the tube. The emission end surface of the waveguide can become split. The consequence of damaging the emission surface of the waveguide is that laser light is beamed sidewards in uncontrolled manner. Thus there is a danger that non-participating tissue would be damaged by uncontrolled laser light, which would thus injure the patient. In addition, the doctor treating the patient could become injured by the uncontrolled emission of laser light.
A further drawback of the known instruments is that the bent tube allows only one fixed operation angle, i.e. a fixed emission direction of the laser light, which is insufficient for the individual anatomy of respective patients. Since the beam direction is adjusted by bending the tube, the tube may not be usable over longer time periods due to material fatigue.
Another drawback of the known instruments is that once having made the adjustment of the beam direction during the treatment, it can no longer be varied. To readjust the direction, the tube must be removed from the operation area and correspondingly re-directed to a new position, whereby the operation time is substantially increased. The manipulations are thus impractical.
The known instruments are therefore not suitable for applying laser light for reducing the concha. The invention on the other hand is not limited to this field of application. Rather, it is basically applicable to all medical fields where a guidewave is inserted into small body cavities or passages and where therapeutic light is to be accurately directed to a point on tissue to be treated, in particular where there is very little space. Examples include arthoscopy, urology, laparoscopy, neurosurgery, etc.
U.S. Pat. No. 4,881,524 mentioned above discloses an instrument for guiding a laser light transmitting fiber in intra-abdominal endoscopic work, wherein this known instrument comprises a shaft to the distal end of which is pivoted a fiber guide for deflecting the distal end of a fiber emerging from the distal end of the shaft. The shaft contains a fiber guide drive tube through which the fiber extends and which is articulated to the fiber guide by means of a link. A lever is provided for shifting the drive tube axially in the shaft to deflect the fiber guide and thus the distal end of the fiber, and a fiber feed device has a fiber feed member mounted for displacement axially of the shaft for advancing and retracting the fiber.
The disadvantage of this known instrument is that the light-emitting end of the waveguide fiber can only be pivoted in one direction out of the longitudinal axis of the shaft. Thus, the working range of this known instrument is restricted.
The invention, however, is not limited to medical applications, but can also be employed in technical applications.
The object of the present invention is then to provide an instrument of the mentioned type, which avoids the above draw-backs and by which a light waveguide for applying light, in particular laser light, can be directed to a difficultly accessible position, where light emission is possible with simple handling in several directions.
SUMMARY OF THE INVENTION
According to the present invention, an instrument for applying light, particularly laser light, into the human or animal body, in particular for endonasal laser surgery, is provided, comprising:
a tubular shaft having a proximal end and a distal end portion, said distal end portion being pivotally connected to a remaining portion of said tubular shaft;
a light waveguide being insertable into said tubular shaft, said light waveguide having a distal light-emitting end which comes to rest in said distal end portion of said tubular shaft;
a manipulating means disposed at said proximal end of said tubular shaft, said manipulating means having at least one movable operating element operatively connected with said distal end portion via an actuator element for pivoting said distal end portion out of a longitudinal axis of said shaft,
wherein said distal end portion is pivotably connected to said r
Leunig Andreas
Rösler Peter
Sroka Ronald
Cohen Lee
Johnson Hank M.
Karl Storz GmbH & Co. KG
St. Onge Steward Johnston & Reens LLC
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