WO2010007639A1

WO2010007639A1 - Multifiber laser device for percutaneous treatments o the like and equipment comprising said device

Info

Publication number: WO2010007639A1
Application number: PCT/IT2009/000298
Authority: WO
Inventors: Leonardo Masotti; Andrea Papini
Original assignee: Elen. S.P.A.
Priority date: 2008-07-14
Filing date: 2009-07-07
Publication date: 2010-01-21
Also published as: ITFI20080129A1

Abstract

A device for supplying laser energy for percutaneous treatments, comprising a support element with a plurality of seats, in which corresponding optical fibers are housed for conveying laser radiation.

Description

MULTIFIBER LASER DEVICE FOR PERCUTANEOUS TREATMENTS OR THE LIKE AND EQUIPMENT COMPRISING SAID DEVICE

DESCRIPTION Technical Field The present invention relates to improvements to laser energy devices for use in surgery, both for aesthetic applications and for surgical applications or in general for medical use. Base of the invention

Aesthetic or medical applications of laser energy are increasingly used, in which it is necessary to irradiate with laser energy, coming from one or more generators, subcutaneous or deeper areas of the body. With this purpose, needles or cannulae are currently used, which are inserted below the skin or anyway into an organ to be treated at the required depth. Inside the cannula or needle an optical fiber is inserted, the end of which projects from the distal end of the needle or cannula or other handpiece, so that from the end of said fiber laser energy can be irradiated once the proximal end of the fiber has been connected to the laser source.

Examples of laser devices for different uses in medicine and surgery are described in DE8907461U1; EP-A-0801928; US-A-5,865,833; EP-A-1428482; US-A-2002/0064328; DE20003349U1 ; EP-A-1574176; WO-A-98/183897; US- A-2006/0095095; US-A-6,206,873.

Devices of this type are used both in the field of aesthetic surgery and for the treatment through laser ablation of tumor tissues or the like.

In the percutaneous laser treatments there is often the need of treating wide regions of an organ, for example for causing necrosis of cancer cells. In this case it is necessary that the laser radiation strikes all the tissue to be treated without however causing overexposure to the laser radiation, which can result in drawbacks, among which the carbonization of the tissue. Similar problems can occur in aesthetic surgery, where it is necessary for example to treat wide surfaces of adipose tissues below the skin, which currently entails prolonged treatment times. Summary of the Invention

The object of the present invention is to provide a laser energy device for percutaneous treatments which entirely or in part overcomes one or more of the drawbacks of the known devices and which furthermore allows treating by means of the same device with different wavelength at the same time or in a particular sequence.

Substantially, the present invention provides for a dispensing device for supplying laser energy for percutaneous treatments, comprising a support element with a plurality of seats, in which corresponding fibers are housed for conveying the laser radiation. Preferably, in each seat an individual fiber is housed, although it would be possible to arrange more fibers in a same seat, for example by staggering the distal ends thereof axially, in such a manner as not to overlap the fiber emission lobes.

In some embodiments of the present invention, the support element can be a cannula, a needle, a probe or a catheter.

In some embodiments, the seats for the optical fibers can have respective apertures for supplying the laser radiation, which are arranged in such a manner that the fiber emission lobes are at least partially staggered one relative to the other.

The support element can present a plurality of lateral seats, arranged about a central axis of the support element. The lateral seats can be closed towards the outside, i.e. they can be integrally obtained inside the material of which the support element is constituted. However, these seats will be preferably made open on the lateral surface of the support element, for practicality of production and also in order to obtain a support with lower diametric dimensions. In this case, in some advantageous embodiments the support element is inserted in a protective member, for example a pervious needle or a sheath, which can have the function of facilitating the penetration of the support element inside the tissues and, as the case may be, of holding the fibers inside their seats.

In some embodiments of the present invention the support element can comprise one or more seats in an about central position relative to the lateral seats, with a front aperture on said support element.

In some embodiments the fibers housed in the lateral seats are designed so as to emit laser radiation lobes in a skew or radial direction.

A device can be envisaged, wherein said lateral seats are defined by holes in a central core forming the support element, these holes exiting on a lateral surface of the support element.

Within the scope of the present invention and of the attached claims, "support element" should be understood as generically any structural element suitable to support a plurality of fibers. This element can be a needle, a probe, a catheter or a cannula, which may be provided with a distal end machined or treated in such a manner as to allow or facilitate the penetration inside a tissue. It can be also a member arranged inside a pervious needle with a point suitable for perforating tissues. In general, the support element can take different shapes according to the number of fibers that it supports, according to the type of instrument in which it must be inserted, according to the nature of the tissues to be treated with the instrument and other. Brief description of the drawings

The invention will be better understood by means of the description below and the attached drawing, which shows a non-restrictive practical embodiment of the invention. More in particular, in the drawing: figure 1 shows a surgical device or instrument formed by an energy laser device for percutaneous treatments, in which the present invention can be embodied; figure 1A shows an enlargement of the distal area of the instrument of figure 1 ; figure 2 shows a partial schematic view of an embodiment of a support element for a plurality of optical fibers; figure 3 shows a schematic front view of the fiber emission lobes of the device of figure 2; figure 4 shows a schematic view of a second embodiment of the support element with a plurality of seats for optical fibers; figure 5 shows a schematic front view of the fiber emission lobes of the device of figure 4.

Detailed description of embodiments of the invention Figure 1 schematically shows a surgical instrument or device for supplying laser energy for percutaneous treatments. The instrument, indicated as a whole with the number 2, has an handpiece 1 with a cannula, probe or pervious needle 3 with a tip 3A through which, a plurality of optical fibers may project, adequately arranged and supported by a support element which is arranged inside the cannula, needle or probe 3. The position of the support element 11 and, consequently, of the end of the fibers can be adjusted so as to vary relative to the tip 3A of the needle 3. In some embodiments, the needle and the support element can be made by a single component, providing that the support is sharpened at the distal end so as to facilitate the penetration in the tissue. In some embodiments a support element can be provided surrounded by a sheath, which prevents the fibers from projecting radially from respective seats open towards the outside, i.e. on the lateral surface of the support element. When the support element itself forms the cannula or perforating needle, in addition to support and guide means for the fibers in the tissue, a lower dimension of the instrument can be obtained, and therefore a lower invasivity thereof.

Figure 1 schematically shows a configuration in which the support element 11 is inserted in a pervious needle 3. Figure 2 schematically shows an embodiment of the support element 11 of the optical fibers, which is surrounded by a sheath 13. The sheath 13 surrounds the support element 11 and closes externally a series of seats 15 arranged in a circumferential manner around the axis of the support element 11. In the embodiment shown in figure 2, four seats 15 are provided, distributed in a uniform manner and staggered by 90° relative to each other, around the circumferential development of the support element 11. In each seat 15 a respective optical fiber F1 , F2, F3, F4 is arranged. It should be understood that the number of seats 15 and therefore of the optical fibers F can vary relative to that shown in figure 2. For example, three seats 15 can be provided, angularly staggered by 120° relative to each other so as to house three optical fibers F1, F2, F3. In another embodiment, even only two seats can be provided, arranged at 180° or anyway staggered one relative to the other by an adequate angle around the longitudinal axis of the support element 11. Embodiments with a number of seats greater than four are also possible. Generally, the number of seats 15 and, consequently, of optical fibers F arranged around the support element 11 and supported by the latter can vary according to the type of application for which the surgical instrument 1 is intended. It is also possible to provide for a support element 11 with a high number of seats 15, only some of which are used according to the type of application that shall be performed with the instrument each time. In other embodiments it is possible to provide for the surgical instrument 1 to present a number of seats equal to the number of optical fibers, but only some of them are connected to the laser source, when the treatment to be performed requires a number of optical fibers lower than that arranged as a whole on the instrument 1.

In some embodiments the various fibers can be connected to laser sources having characteristics different from each other, for example two laser sources with two different wavelength. In this way it is possible to supply two different wavelengths, each of which with a group of one or more fibers, simultaneously or sequentially or in any time sequence, for example first a wavelength, then sequentially two wavelengths and then a second wavelength.

Figure 3 schematically shows a front view of the arrangement of the emission lobes indicated with L1 , L2, L3, L4 of the laser energy supplied by the distal ends of the fibers F1 - F4 housed inside the support element 11. As it can be observed in figure 3, the arrangement is such that the lobes L1 - L4 preferably do not overlap, so as to avoid that in the tissue, into which the tip of the instrument 1 is inserted, areas are present subjected to a power supply double than that conveyed by each fiber, or anyway areas in which the effects of the emission of one or more adjacent fibers overlap with one another, what could entail a damage or anyway undesired side effects on the tissue. In other applications, a partial overlapping of the emission lobes can allow a greater uniformity of radiation in the tissue to be treated, as in the areas of partial overlapping the same intensity is achieved, or slightly different from that obtained in the central area of the lobe.

Figure 4 shows a different embodiment of a device or instrument according to the present invention. In this case a support element is provided, again indicated with the number 11 , in which four peripheral seats are obtained, again indicated with the number 15, for respective four fibers F1 , F2, F3, F4 advantageously arranged staggered one relative to the other by 90° around the axis of the support element 11. In this embodiment, advantageously, each fiber has an end E shaped in such a manner that the emission lobe of each fiber is substantially skew, i.e. the energy is irradiated at least partially in radial direction, i.e. with a component orthogonal to the longitudinal axis of the support element. In some embodiments the end of the fiber can be shaped in such a manner so as to emit only laterally, i.e. in radial direction towards the outside of the support. It is also possible to shape in a different manner the ends of two or more fibers of the same handpiece or instrument. In the embodiment of figure 3 a seat 16 is furthermore provided, nearly central at correspondence of the longitudinal axis of the support element 11, in which a fifth fiber F5 is housed which, in the illustrated example, slightly projects in axial direction relative to the support element 11. Therefore, in the configuration of figure 4 the surgical instrument will be provided totally with five fibers.

The support element 11 can include suction conduits for gas or liquid materials produced by the interaction between the laser energy and the treated tissues. In the embodiment of figure 4, number 21 indicates three suction conduits of this type provided in the support element 11. It should be understood that the number and the arrangement of these suction holes can be different from those illustrated in figure 4. For example, suction holes may be provided also on the lateral surface of the support element.

Figure 5 schematically shows a front view of the arrangement of emission lobes L1 , L2, L3, L4 of the optical fibers F1-F4 arranged around the axis of the support element 11 in the configuration of figure 4. L5 indicates the emission lobe of the central fiber F5. Also in this case the arrangement is such that the area of overlapping between the various lobes is optimized or avoided for the reasons described above.

The support element 15 can have an end slightly inclined relative to the axis, so as to form a sharpened edge 15B to facilitate the cutting of the tissue and the penetration by the instrument. In some embodiment it is sufficient to notch the epidermis through a sharpened edge 15B of the support element 15, also if there is no pervious needle with sharpened tip, as the subsequent penetration by the instrument into the tissue below is facilitated by the effect of the laser energy emitted by the fibers. It is also possible preliminarily to use a sharpened device to make the hole for the entrance of the support into the skin.

It is understood that the drawing only shows an example provided by way of a practical arrangement of the present invention, which can vary in forms and arrangements without however departing from the scope of the concept underlying the invention. Any reference numbers in the appended claims are provided for the sole purpose of facilitating reading of the claims in the light of the description and the drawing, and do not in any manner limit the scope of protection represented by the claims.

Claims

I. A device for supplying laser energy for percutaneous treatments, comprising a support element with a plurality of seats, in which corresponding optical fibers are arranged for conveying laser radiation.

2. A device as claimed in claim 1 , in which in each seat a single fiber is housed.

3. A device as claimed in claim 1 or 2, in which said support element is a cannula, a needle, a probe or a catheter.

4. A device as claimed in claim 1 , 2 or 3, in which said plurality of seats have respective openings for supplying the laser radiation, which are arranged so that the fiber emission lobes are at least partially staggered with respect to each other.

5. A device as claimed in one or more of the previous claims, in which said support element has a plurality of lateral seats, arranged around a central axis of said support element.

6. A device as claimed in claim 5, in which said support element comprises at least one further seat in a nearly central position with respect to said lateral seats, with a front aperture on said support element.

7. A device as claimed in claim 5 or 6, in which the fibers housed inside said lateral seats are designed so as to emit laser radiation lobes in an oblique or radial direction.

8. A device as claimed in claim 5 or 6 or 7, in which said lateral seats are defined by holes in a central core forming said support element, said holes surfacing on a lateral surface of the support element.

9. A device as claimed in claim 5 or 6 or 7, in which said lateral seats are in the form of grooves in a central core surrounded by an outer sheath.

10. A device as claimed in one or more of claims 5 to 9, in which said lateral seats are provided with side openings for emitting the laser radiation, all arranged at the same level along the the axial development of said support element.

I I . A device as claimed in one or more of claims 5 to 9, in which said lateral seats are provided with side openings for emitting the laser radiation arranged at variable positions along the axial development of said support element.

12. A device as claimed in one or more of the previous claims, in which said support element is provided with suction ducts for sucking the products deriving from the interaction between the laser radiation and the treated tissues.

13. A laser equipment comprising at least one laser source and one device as claimed in one or more of the previous claims, or alternatively at least two laser sources, and wherein said device is connected with a first group of fibers to a first of said sources and with a second group of fibers to the second of said sources.

14. A method for supplying laser energy to a surgical instrument, comprising: a) associating a plurality of optical fibers to a single support; b) connecting said fibers to at least one laser source; c) supplying laser energy through said fibers.

15. A method as claimed in claim 14, comprising: • connecting a first group of said fibers to a first laser source at a first wavelength and a second group of fibers to a second laser source at a second wavelength, different from the first wavelength; • supplying, according to a preset time distribution, laser energy at different wavelengths through said fibers.