RF HYPERTHERMIA WITH NEEDLE ELECTRODES ENCLOSING A VOLUME
Field of the Invention This invention concerns a medical instrument in the form of a needle treatment of tumours, in particular even if not exclusively for pulmonary tumours, using radio-frequency induced hyperthermia. State of the Art
Instruments for the above mentioned use usually having a body in the shape of a tubular needle housing several electrodes which have proximal ends connected to a radio-frequency generator and active distal arc shaped ends are already well-known. The electrodes can be moved between a passive position fully retracted into the tubular body, and an active forward position where the arch shaped distal ends protrude from the point of the tubular body. According to a known system, the arch shaped ends of the electrodes when in the forward position are differently oriented but all face backwards, that is towards the proximal end of the tubular body. Their functional efficacy is however limited in that the arch shaped distal ends tend either to move away from or to push the part to be treated away. Furthermore, an instrument of this kind is without a guide wire and an independent thermocouple for reading the temperature in the area being treated.
According to another known embodiment, in an instrument similar to the type in question, the arch shaped active terminals of the electrodes face and converge forwards, and when retracted to move into the passive position,
they have to be pulled back and housed in an axially moveable part positioned at the distal end of the body. Such a moveable part however, besides being complicated to make, becomes, on the one hand, a further elongation of the body of the instrument when the electrodes are retracted and the needle is inserted into the patient's body, and on the other hand it has to be axially retracted into the needle to allow the electrodes to protrude. In this system as well there is no guide wire. Objectives and Summary of the Invention
This invention is aimed at remedying the drawbacks and disadvantages known to exist in the medical instruments described above.
It is in fact one objective of this invention to provide an instrument in the form of a needle with several active electrodes, improved in design and functionally more practical and efficient, for treating tumours, in particular lung tumours, using radio-frequency induced hyperthermia. Another object of the invention is to provide an instrument in the form of a needle with radio-frequency active electrodes, where the arched ends of the electrodes face and converge forwards, but can be retracted into the body of the needle, excluding the presence of a moveable distal part.
These objects are achieved in a medical instrument with several active electrodes in compliance with at least claim 1.
The radio-frequency active instrument structured in this way can be made to come into contact with the part to be treated without any difficulty, with the exclusion of the tendency to push it away as happens in the already known instruments, with the added possibility of having it attach itself to the part by means of a barb passing through the body of the instrument.
Brief Description of the Drawings
The invention will however be illustrated more in detail in the following description made in reference to the enclosed indicative and non-limiting drawings, in which: Fig. 1 shows a view, of one of the possible configurations of the invention, of a distal part of the instrument with electrodes protruding in an operating position and a thermistor;
Fig. 2 shows a longitudinal section of the instrument in Fig. 1 ;
Fig. 3 shows a cross-section as in Fig. 2, but with electrodes retracted; Fig. 4 shows a view of the head of the instrument in Fig. ;
Fig. 5 shows an enlarged cross-section in direction of the arrows A-A in Fig. 1
Fig. 6 shows a section as in Fig. 2, but in a variation of the configuration of the instrument; and Fig. 7 shows an enlarged cross-section in direction of the arrows B-B in
Fig. 6 Detailed Description of the Invention
The instrument shown comprises of a guide body in the form of a hollow needle 11 , only a distal portion of which including the end point 11' being shown, for insertion into the patient's body until it reaches the part to be treated.
The body or guide needle 11 has a longitudinal hole 12 and at least a part of its length can be covered externally by an insulating sheath.
Two or more electrodes 13 (for example in the drawing there are four) stretching equidistant or non equidistant extend in the guide needle body from
the proximal to the distal part of the body itself.
The electrodes 13 are each made up of a flexible filiform element made of a suitable material such as for example Nitinol ®, with a non-round cross- section, preferably flat or flattened for at least a part of their length. The proximal ends of the electrodes 13 are connected, in the known way, to at least on connection, not shown, and by means of this to a radio- frequency generator connector. The electrodes 13 are mainly rectilinear except for a distal segment which is pre-bent using a known technique, forming an arch or hook 14. Using the connector which joins them, the electrodes 13 can be moved longitudinally in the body of guide needle 11 between a retracted passive and a forward active position. In the retracted position the electrodes 13 are fully retracted inside the body or guide needle, including their arch shaped or hooked 14 distal segment, which is obliged to adopt a rectilinear shape as shown in Fig. 3. In the forward position, the distal segments 13 protrude from different sides of the body or guide needle 11, automatically adopting an arched or hook configuration 14 - Figs. 1 , 2.
The arched or hook shaped distal segments 14 are designed and oriented to extend forwards and converge beyond point 11' of the body or guide needle 11. They are helped to adopt this configuration by the particular cross-section of the elements forming the electrodes, chosen to prevent them from turning on an axis and to allow them to bend into an arch shape only in the required direction.
Furthermore, in order to allow correct placement of the electrodes inside the body or guide needle 11 , including correct sliding and orientation ,
each electrode 13 is housed and guided in a respective guide device.
According to one configuration in fact, each electrode 13 passes longitudinally inside a corresponding guide tube 15 placed in the body or guide needle 11. The guide tube 15 will have, for at least a part of its length, a round cross-section which is the same as the electrode it houses to prevent it from turning -Fig. 5.
The guide tubes 15 can be and remain fixed in the body of guide needle 11 whereas the electrodes are moved between the retracted and forward positions described above. As an alternative, the guide tubes 15 can also be moved between a retracted and forward position, but independently from the electrodes 13 - Figs. 1 - 3. In this way the proximal ends of the guide tubes 15 can be attached to a respective grip, not shown, by means of which they can be moved forwards and backwards. Subsequently, starting from the retracted position - Fig. 3 - where the guide tubes and electrodes are fully retracted into the body 11 , first the guide tubes 15 will be moved forward followed by the electrodes 13 until they adopt their active position where, as described above, the arched distal segments 14 will protrude and converge forwards of the point of the body or guide needle. In particular, when they are in the forward position, the distal parts of the guide tubes 15 are made to protrude from the body or guide needle - Figs. 1 and 2 - and if appropriately rounded or sharpened, they can become an anchoring means for the instrument to the part to be treated with the electrodes, facilitating approach to and the action of the latter on the part itself. In a variation in design shown in Figs. 6 and 7, a grooved core 16 can
be placed in the body or guide needle 11 in order to house and guide the electrodes 13, the core having at least the same number of longitudinal guide conduits 17 as there are electrodes 13. The core 16 is stable and each of its conduits 17 is housed and moves an electrode 13 having the characteristics described above. The cross-section of each guide conduit 17 is compatible with the cross-section of the electrode so as to prevent it from turning. The distal end of each guide conduit 17 will also be shaped to facilitate retraction and better still protrusion of the distal end of the respective electrode in and out of the body or guide needle. The electrodes 13, positioned and oriented as described above, are particularly efficient in that they can approach and treat the part using radio- frequency hyperthermia without the risk of pushing said part away.
Furthermore, a retractable wire 20 terminating in a barb 21 similar to a hook and which can be moved by hand or by a special spring loaded device can be placed in a special duct 18 as shown in Fig. 1 or in a longitudinal hole 19 provided in the core 16 as shown in Figs. 6 and 7. When the wire 20 is in a forward position protruding beyond point 11' of the body or guide needle, the barb (hook) 21 comes into contact with the part to be treated to hold it and/or even to draw it closer to the electrodes in the active position. Worthy of note is the fact that the body or guide needle can house other components usually used such as a thermistor 22, also retractable, to read the temperature in the vicinity of the part requiring treatment.