Device for treating tissue of a body

文档序号:957289 发布日期:2020-10-30 浏览:4次 中文

阅读说明:本技术 用于对身体的组织进行治疗的装置 (Device for treating tissue of a body ) 是由 奥斯卡斯·泽林斯 道曼茨·普法罗德斯 于 2019-09-19 设计创作,主要内容包括:本发明涉及一种用于对身体的组织进行治疗的装置(17),其特别地用于优选为下肢中的静脉曲张、精索静脉曲张和/或血管畸形的永久性阻塞,和/或用于在优选地激光辅助脂解的美容手术中使用,和/或用于借助于激光诱导热疗法和/或光动力疗法进行的肿瘤治疗,该装置借助于通过激光能量在周向上并且在腔内照射所述组织的光扩散器(13),所述扩散器(13)在其近端部处经由柔性波导(12)连接至激光能量源(10),该柔性波导包括由光学包层(2)覆盖的光纤芯(1),该光学包层的折射率小于芯(1)的折射率,其中在包层(2)中和/或芯(1)中设置有缺陷部(18),该缺陷部设计为凹部并且适于引导光,优选地适于使在芯(1)和/或其光学包层(2)内传播的光在大致径向方向上折射和/或反射,其中,设置有对于激光是透明的盖(7),该盖以流体密封和/或液体密封的方式封闭芯(1)及其的光学包层(2)的远端部。根据本发明的装置(17)的特征在于,所述光学包层(2)的外表面(19)在所述缺陷部(18)之间的区域(A)中熔合至盖(7)的内表面(21),优选地熔合至盖(7)的内径,和/或光学包层(2)的在设置有缺陷部(18)的区域(A)的前面和/或后面延伸一定距离的外表面(19)熔合至盖(7)的内表面(21),优选地熔合至盖(7)的内径。(The invention relates to a device (17) for the treatment of tissue of the body, in particular for permanent occlusion of varicose veins, varicoceles and/or vascular malformations, preferably in the lower limbs, and/or for use in cosmetic surgery, preferably laser-assisted lipolysis, and/or for tumor treatment by means of laser-induced thermal and/or photodynamic therapy, by means of an optical diffuser (13) which irradiates the tissue circumferentially and endoluminally by laser energy, the diffuser (13) being connected at its proximal end to a source (10) of laser energy via a flexible waveguide (12) comprising an optical fiber core (1) covered by an optical cladding (2) having a refractive index which is smaller than that of the core (1), wherein a defect (18) is provided in the cladding (2) and/or in the core (1), the defect is designed as a recess and is adapted to guide light, preferably to refract and/or reflect light propagating within the core (1) and/or its optical cladding (2) in a substantially radial direction, wherein a cover (7) transparent to the laser is provided which closes the distal end of the core (1) and its optical cladding (2) in a fluid-tight and/or liquid-tight manner. The device (17) according to the invention is characterized in that the outer surface (19) of the optical cladding (2) is fused in the area (A) between the defects (18) to the inner surface (21) of the cover (7), preferably to the inner diameter of the cover (7), and/or that the outer surface (19) of the optical cladding (2) extending a distance in front of and/or behind the area (A) where the defects (18) are provided is fused to the inner surface (21) of the cover (7), preferably to the inner diameter of the cover (7).)

1. A device (17) for treating a tissue of a body,

in particular, the device is used for permanent occlusion of varicose veins, preferably in the lower extremities, varicoceles and/or permanent occlusion of vascular malformations, and/or for use in cosmetic surgery, preferably laser-assisted lipolysis, and/or for tumour treatment by means of laser-induced thermotherapy and/or photodynamic therapy,

the device treats the tissue by means of an optical diffuser (13) irradiating the tissue circumferentially and endoluminally by laser energy,

the diffuser (13) is connected to a laser energy source (10) at its proximal end via a flexible waveguide (12) comprising an optical fiber core (1) covered by an optical cladding (2), the refractive index of the optical cladding (2) being smaller than the refractive index of the core (1),

Wherein a defect (18) is provided in the cladding (2) and/or in the core (1), which defect is designed as a recess and is adapted to guide light, preferably to refract and/or reflect light propagating within the core (1) and/or the optical cladding (2) of the core in a substantially radial direction,

wherein a cover (7) is provided, which is transparent to the laser light and closes the core (1) and the distal end of the core's optical cladding (2) in a fluid-tight and/or liquid-tight manner,

the device is characterized in that,

an outer surface (19) of the optical cladding (2) is fused to an inner surface (21) of the cap (7), preferably to an inner diameter of the cap (7), and/or in a region (A) between the defects (18)

An outer surface (19) of the optical cladding (2) extending a distance in front of and/or behind the region (A) where the defect (18) is provided is fused to an inner surface (21) of the cap (7), preferably to an inner diameter of the cap (7).

2. The device according to claim 1, characterized in that the outer surface (19) of the optical cladding (2) is fused continuously and/or circumferentially and/or completely to the inner surface (21) of the cover (7), preferably to the inner diameter of the cover (7), and/or in the region (a) between the defects (18)

An outer surface (19) of the optical cladding (2) extending a distance in front of and/or behind the region (A) in which the defect (18) is provided is continuously and/or circumferentially and/or completely fused to an inner surface (21) of the cover (7), preferably to an inner diameter of the cover (7), and/or

The outer surface (19) of the optical cladding (2) is fused in the region (A) between the defects (18), preferably in a punctiform manner and/or by a longitudinal weld, in part to the inner surface (21) of the cover (7), preferably to the inner diameter of the cover (7), and/or

An outer surface (19) of the optical cladding (2) extending a distance in front of and/or behind the region (A) where the defect (18) is provided is preferably partially fused to an inner surface (21) of the cover (7), preferably to an inner diameter of the cover (7), in a punctiform manner and/or by a longitudinal weld.

3. The device according to claim 1 or 2, characterized in that the cladding (2) is firmly bonded to the cover (7), in particular in a material-locking manner, in a fusion region (32) in which the cladding (2) is fused to the cover (7).

4. The device according to one or more of the preceding claims, characterized in that the outer diameter (22) of said core (1) is between 100 and 1000 μm, preferably between 200 and 800 μm, more preferably between 300 and 700 μm, and in particular between 350 and 600 μm, and/or

The outer diameter (23) of the cladding (2) is between 110 μm and 1200 μm, preferably between 250 μm and 850 μm, more preferably between 350 μm and 750 μm, and in particular between 400 μm and 650 μm, and/or

The jacket thickness (24) of the cladding (2) is between 1% and 40% of the outer diameter (22) of the core (1), preferably between 5% and 20% of the outer diameter (22) of the core (1).

5. Device according to one or more of the preceding claims, characterized in that a protective sheath (25) is provided, preferably at the distal end of the waveguide (12),

in particular, wherein the protective sheath (25) comprises at least one buffer layer (3) and/or an outer sheath (14) adjacent to the optical cladding (2) of the core (1), and/or in particular wherein the protective sheath (25) and/or the outer sheath (14) is joined to the cover (7), and/or in particular wherein the protective sheath (25) and/or the outer sheath (14) is designed as a plastic coating, preferably an extruded plastic coating.

6. The device according to one or more of the preceding claims, characterized in that said protective sheath (25) and/or its outer sheath (14) is at least partially removed at the distal end of said waveguide (12) so as to uncover said core (1) and its optical cladding (2),

And/or the defect (18) extends into the cladding (2), preferably so as to expose the core (1), and/or the defect (18) extends into the core (1).

7. The device according to one or more of the preceding claims, characterized in that said defect (18) is designed as a groove (4, 5), said groove (4, 5) being adapted to refract and/or reflect light propagating within said core (1) and its optical cladding (2) in a substantially radial direction,

in particular, wherein the grooves (4, 5) comprise at least two helical grooves (4, 5), the grooves (4, 5) extending through the optical cladding (2) into the core (1), wherein successive grooves (4, 5) of each of the helical grooves alternate along a longitudinally extending outer surface (19) of the core (1) and the optical cladding (2) of the core,

and/or in particular wherein the groove comprises at least one circular groove and/or elliptical groove (26),

and/or in particular wherein the grooves comprise at least one longitudinal groove (27),

and/or in particular wherein the grooves comprise at least one punctiform groove and/or interruption groove (28).

8. Device according to one or more of the preceding claims, characterized in that the depth (30) and/or the width (31) and/or the length of said defect (18), preferably of said groove (4, 5), increases in the direction towards the distal end of said core (1),

In particular, wherein the depth (30) and/or width (31) and/or length of the defect (18) is increased by up to 1000%, preferably by up to 800%, more preferably by up to 400%, in particular relative to the minimum depth (30) and/or width (31) and/or length of the defect (18).

9. The device according to one or more of the preceding claims, characterized in that the material of said core (1) comprises fused silica, in particular quartz glass; and/or the material of the cladding (2) comprises fused silica, in particular quartz glass,

in particular wherein the fused silica material of the core (1) is different from the fused silica material of the cladding (2),

and/or in particular wherein the fused silica material of the cladding (2) and/or the core (1) is doped, in particular wherein the cladding (2) is doped with fluorine, and/or in particular wherein the core (1) is doped with germanium.

10. Device according to one or more of the preceding claims, characterized in that the length (29) of said area (A) provided with said defect (18), preferably of said area (A) provided with said groove (4, 5), is between 0.1 and 30mm, preferably between 1 and 15mm, more preferably between 3 and 4 mm.

11. A device according to one or more of the preceding claims, characterized in that the distal end of the core (1) is terminated by a reflector (6),

in particular, wherein the reflector (6) is formed by a distal end of the cladding (2) and/or the core (1).

12. The device according to claim 11, characterized in that the reflector (6) has a conical shape, the cone angle of the reflector (6) designed as a reflection cone being about 60 degrees.

13. The device according to claim 11, characterized in that the reflector (6) has a conical reflective conical surface, the cone angle of the reflective cone (6) being about 68-90 degrees.

14. The device according to one or more of the preceding claims, characterized in that the proximal end of the hole of said cover (7) is provided with the following sections (8): the sections have an increased inner diameter corresponding to the outer diameter of the buffer layer (3) and/or the outer diameter (22) of the core (1).

15. The device according to claim 14, wherein the section (8) having an increased inner diameter at the proximal end of the cap (7) is glued to at least one of the buffer layer (3), and/or to the core (1), and/or to the cladding (2), in particular wherein the glue (9) additionally provides a smooth transition between the outer surface of the cap (7) and the outer surface of the outer sheath (14), in particular wherein the glue additionally provides a smooth transition between the outer diameter of the cap and the outer diameter of the outer sheath.

16. The device according to one or more of the preceding claims, characterized in that the inner surface (21) of said hole of said cover (7) is provided with an antireflection coating.

17. The device according to one or more of the preceding claims, characterized in that said defect (18), preferably said groove (4, 5), is obtained by means of CO and by means of the following2Produced by cutting with a laser beam (20): -rotating the core (1) and the optical cladding (2) of the core relative to a laser beam (20) around a longitudinal axis (16) of the core, and-moving the laser beam (20) and/or the core (1) and the optical cladding (2) of the core axially along the longitudinal axis (16) of the core (1) in synchronization with the rotation of the core (1).

18. The device according to one or more of the preceding claims, characterized in that the starting points of said helical grooves (4, 5) are angularly offset in the circumferential direction of said core (1), the offset angle being 360 degrees divided by the number of grooves.

19. The device according to one or more of the preceding claims, characterized in that two or more of said helical flutes (4, 5) have substantially the same helix angle (a) value with respect to the longitudinal axis (16) of said core (1) and extend in the same direction.

20. A device according to one or more of the preceding claims, characterized in that two or more of said helical flutes (4, 5) have substantially the same helix angle (a) value, but extend in opposite directions, so that successive flutes of a respective pair of said helical flutes cross each other.

21. The device according to one or more of the preceding claims, characterized in that the value of the helix angle (a) of said helical flutes (4, 5) with respect to the longitudinal axis (16) of said core (1) is chosen to be about 60 °.

22. Method for manufacturing a device (17) for the treatment of tissue of a body according to one of the preceding claims,

wherein an outer surface (19) of the optical cladding (2) is fused to an inner diameter of the cap (7) in the region (A) between the defects (18), and/or

Wherein an outer surface (19) of the optical cladding (2) extending a distance in front of and/or behind the region (A) where the defect (18) is provided is fused to an inner surface (21) of the cover (7), preferably to an inner diameter of the cover (7).

23. Method according to claim 22, characterized in that the device (17), preferably the diffuser (13), more preferably the cover (7) and the cladding (2), is heated at least in the area (A, B, C) to be fused, in particular such that the cover (7) is at least partially collapsed and fused to the optical cladding (2) and/or the core (1), in particular wherein a vacuum is applied to the still open end of the cover (7) before and/or during heating.

24. Method according to claim 22 or 23, characterized in that a portion of the protective sheath (25) from the distal end of the waveguide (12) is removed, preferably the length of said portion being longer than the length of the section of the core (1) and of the cladding (2) of the core where the defect (18) is to be provided, in particular the length of said portion being longer than the length of the section of the core (1) and of the cladding (2) of the core where the slot (4, 5) is to be provided, and/or

Removing a portion of the outer sheath (14) of the protective sheath (25), in particular a length substantially corresponding to the length of the increased inner diameter portion at the proximal end of the cap (7).

25. Method according to one or more of claims 22 to 24, characterized in that the reflector (6) is provided at the distal end of the core (1) and the cladding (2) of the core, which are bare, in particular by removing material of the core (1) and/or the cladding (2) to provide the reflector (6).

26. Method according to one or more of claims 22 to 25, characterized in that said defect (18), in particular said groove (4, 5), is obtained by means of CO2The laser beam (20) and/or the plasma beam cutting the defect (18), in particular the groove (4, 5), through the optical cladding (2), in particular into the core (1),

In particular, wherein the core (1) and the optical cladding (2) of the core are rotated relative to a laser beam (20) about a longitudinal axis (16) of the core, and/or in particular wherein the laser beam (20) and/or the waveguide (12) and the core (1) and the optical cladding (2) of the core are moved axially along the longitudinal axis (16) of the core (1) in a manner synchronized with the rotation of the core (1).

27. Method according to one or more of claims 22 to 26, characterized in that said cover (7) is slid over said core (1) and said region (a) of optical cladding (2) provided with said defect (18), preferably also onto said outer sheath (14) of said buffer layer (3) from which said protective sheath (25) has been removed, in particular onto a short length of outer layer from which said protective sheath has been removed.

28. Method according to one or more of claims 22 to 27, characterized in that, after fusing the cover (7) to the core (1) and/or the cladding (2), the proximal end of the cover (7) is glued to the protective sheath (15), preferably to the buffer layer (3) and/or the outer sheath (14),

in particular, by inserting the device (17) comprising the lid (7) and/or the diffuser (13) through an annular seal at the top of a vacuum-tight container, in which the distal end of the waveguide (12) is housed, having a bottle filled with glue at the bottom of the vacuum-tight container and applying at least a partial vacuum inside the container; and/or by introducing the diffuser (13) and/or the device (17) until after the distal end of the cap (7) has entered the glue-filled bottle,

In particular wherein the vacuum is released from the container such that the adhesive (9) from the bottle is sucked into a gap (15), preferably any gap, between the cap (7), the cushioning layer (3) and the unfused proximal portions of the core (1) and the cladding (2) of the core,

and/or in particular wherein the adhesive (9) is shaped and preferably bridges the proximal portion of the cover (7) with the outer sheath (14) of the protective sheath (25), in particular bridges the proximal portion of the cover with the outer layer of the protective sheath, and more preferably removes any adhesive still adhering to the outer surface of the cover (7).

Technical Field

The invention relates to a device for treating body tissue by means of a laser diffuser which irradiates the body tissue circumferentially and intraluminally with laser light.

In particular, the device for the treatment of body tissues is intended for permanent occlusion of varicose veins, preferably in the lower extremities. Moreover, the device is preferably intended for permanent occlusion of varicoceles and/or vascular malformations. Alternatively or additionally, the device may be intended for use in cosmetic surgery, in particular such as laser assisted lipolysis, and/or preferably for tumour treatment by means of Laser Induced Thermal Therapy (LITT) and/or photodynamic therapy (PDT).

Background

The diffuser is connected at its proximal end to a source of laser energy via a flexible waveguide comprising an optical fiber core covered by an optical cladding having a refractive index less than that of the core. The defect is arranged in the cladding and/or in the core, wherein the defect is adapted to guide light, preferably to refract and/or reflect light propagating within the core and/or its optical cladding in a substantially radial direction. The defect is designed as a recess.

The defect designed as a recess can extend at least into the cladding and preferably into the core. In particular, the defects designed as recesses may differ from one another, in particular with respect to depth. Preferably, the at least one defect may extend only into the cladding and thus not into the core, wherein the at least one further defect may extend into the cladding and into the core.

Furthermore, a cover is provided, wherein the cover is transparent to the laser, closing the distal end of the core and its optical cladding in a fluid-tight and/or liquid-tight manner. The laser may pass through the optical cladding and the cap.

In the medical field, diffusers are commonly used on the distal end of waveguides as a means for scattering and/or redirecting optical power along the length of the distal end of the core of the waveguide at a uniform 360-degree cylindrical output. This is facilitated, for example, by: roughening the core or machining defects designed as grooves or threads into the glass of the fiber core to a depth sufficient to extract and scatter and/or redirect light traveling through the fiber core along the longitudinal axis of the core. Light emitted from the defect or slot illuminates the area of tissue surrounding the diffuser with optical power, making it useful for applications such as photodynamic therapy or coagulation and/or ablation of tissue, blood vessels or hollow organs. In order to protect the distal end of the core from which its protective sheath has been removed, it is conventional for this distal end to be surrounded and covered by a cover which is transparent to the laser light emitted by the core.

In the field of lighting, it is well known for a long time to direct light from a point source into one or both ends of a cylindrical rod made of refractive material and to redirect the light propagating inside the rod in the radial and circumferential directions of the rod by cutting circular or spiral grooves into the outer surface of the rod, as shown in FR 1325014. Light traveling within the rod exits the rod at the slot. If light is introduced into the rod from only one end of the rod, the other end may be terminated by a conical reflector. In order to obtain a uniform radiation distribution over the length of the rod, it is also known to use deeper grooves at positions of the rod further from the light source to improve the uniform radiation distribution.

The same principle is also used in the medical field, as exemplified in the embodiment of the laser diffuser shown in fig. 6 of EP 0598984 a 1. In this embodiment, an angled slot is cut into the core of the waveguide at an angle to the longitudinal axis of the waveguide. Furthermore, this embodiment is provided with a conical reflector at the distal end of the core, and the section of the core comprising the groove and the conical reflector is enclosed in a cover transparent to the laser.

The design of such diffusers varies depending on the desired length of the light emitting region and the required light uniformity and available laser energy.

In practice, it has been found that in a few cases after treatment of the tissue of the body, the cap remains in the tissue of the body of the patient, from which the core and the waveguide have been extracted. Unfortunately, the residue of the cover in the tissues of the body risks infection and therefore endangers the health of the patient. Not only is the risk of infection increased due to the use of known diffusers, but also the detached cover and/or the suspended cover may rupture the tissue of the body and may thus cause internal bleeding.

In the known device, the risk of pulling the light diffuser out of the tissue of the body together with the wick, while only retaining the cover in the tissue of the body, cannot be prevented.

Disclosure of Invention

It is an object of the present invention to provide a device for treatment of tissue of a body by means of a laser diffuser, which avoids or at least reduces the disadvantages of the prior art.

The invention relates to a device for the treatment of tissue of the body, in particular for permanent occlusion of varicose veins, varicoceles and/or vascular malformations, preferably in the lower limbs, and/or for cosmetic surgery, preferably laser-assisted lipolysis, and/or for tumour treatment by means of laser-induced thermotherapy and/or photodynamic therapy, by means of an optical diffuser which irradiates the tissue circumferentially and endoluminally by laser light, the diffuser being connected at its proximal end to a laser energy source via a flexible waveguide comprising an optical fiber core covered by an optical cladding, the refractive index of which is smaller than that of the core, wherein in the cladding and/or in the core there is a defect designed as a recess which is adapted to guide light, preferably to refract and/or reflect light propagating in the core and/or its optical cladding in a substantially radial direction, and wherein a cover transparent to the laser is provided, which closes the distal end of the core and its optical cladding in a fluid-tight and/or liquid-tight manner.

The optical fiber core is coaxially surrounded by a cladding, in particular wherein the jacket mechanically protects the core and in particular prevents the optical fiber from breaking during use or transport.

The cladding is specifically intended to prevent the light waves from escaping or emitting from the core. The light energy travels along the path of least resistance. In particular, when the light wave travels along the core and encounters an etch of the core and a defect in the cladding and/or the core, the wave will begin to escape through the defect and be emitted into the surrounding blood vessels and/or veins.

The inventive device for treating tissue of a body is characterized in that in the region between the defects the outer surface of the optical cladding is fused to the inner surface of the cap, in particular to the inner diameter of the cap. Alternatively or additionally, the inventive device for the treatment of tissue of a body is characterized in that the outer surface of the optical cladding is fused to the inner surface of the cap, in particular the inner diameter of the cap, in the region between the defects.

According to the invention, the cover is fused to the optical cladding at least partially and/or at least in partial regions, i.e. at least in the region between the defects and/or at least partially in the region in front of (before) and/or behind the defects.

The region in front of and/or behind the region provided with the defect particularly refers to the direction of propagation of the laser light, particularly wherein the laser light first travels through the region in front of the region provided with the defect, then through the region provided with the defect and then through the region behind the region provided with the defect.

Due to the fusion of the cap with the optical cladding, the cap is particularly firmly bonded to the optical cladding and cannot be pulled out during the treatment of the tissue of the body. The present invention is preferably able to overcome the drawbacks of the prior art with respect to detachment and/or removal of the cap during treatment of the tissue of the body. The cover may be securely attached to the optical cladding at least in the fused region and/or in the fused portion region. The invention is based on the reduction of the risk of infection by treating the tissue of the body with the device. In particular, accidental and/or unintentional detachment and/or removal of the cap in the vein of the patient, for example, is avoided.

Furthermore, since the cover is bonded to the waveguide not only at its distal end, the fluid-and/or liquid-tightness closing the distal end of the core is improved.

Preferably, a short longitudinal length of the bare optical cladding of the core before and/or after the region provided with the defect may be fused to the cladding of the cover, in particular to counteract a reduction in mechanical stability caused by the defect. The inner diameter of the cap is preferably about the same as the outer diameter of the core (including its optical cladding). The optical cladding may also be fused to the inner diameter of the cap at least in some regions and/or partial regions between said defects.

Furthermore, the device may be used in the field of "phlebotomy" medical applications.

The laser source may be a conventional laser source or a diode laser source.

Whether the light is refracted or reflected depends on, inter alia, the form of the defect and the angle of incidence of the laser light. The angle of incidence may be of such a magnitude that total internal reflection occurs. Also, the refraction or reflection of light may depend on the relationship of the refractive indices. For light, refraction follows in particular snell's law, which states that, for a given pair of media, the angle of incidence α1And angle of refraction alpha2The ratio of the sine of (a) is equal to the ratio of the refractive indices of the two media (n2/n 1). Index 1 refers to the first medium, i.e. the core, whereas index 2 refers to the second medium, i.e. the cladding:

the total internal reflection is in particular defined by the critical angle. If the angle of incidence is greater than the critical angle, total internal reflection occurs. The light is reflected. Given that light or other electromagnetic waves propagate in isotropic media, there are known formulas for critical angles in terms of refractive index. The angle of incidence must be greater than

For total internal reflection, where the index critical value refers to the critical angle.

According to a preferred embodiment of the invention, the outer surface of the optical cladding is fused continuously and/or circumferentially and/or completely to the inner surface of the cap, in particular to the inner diameter of the cap, in the region between the defects. The fusion zone between the defects is therefore designed such that the fusion zone, in particular the fusion section zone, is arranged continuously and/or in the circumferential direction and/or completely. This may in particular ensure a secure attachment of the cover to the optical cladding.

Alternatively or additionally, the outer surface of the optical cladding, which extends a distance in front of and/or behind the region in which the defect is provided, is preferably fused to the inner surface of the cap, in particular the inner diameter of the cap, continuously and/or circumferentially and/or completely. Thus, the fused areas, in particular the areas between the defects and/or the areas in front of and/or behind the areas provided with defects, can be fused in the following way: such that the fused region may be disposed 360 degrees circumferentially around the optical cladding.

In a further preferred embodiment, the outer surface of the optical cladding is partially fused in a spot-like manner and/or by a longitudinal weld to the inner surface of the cover, in particular to the inner diameter of the cover, in the region between the defects, and/or the outer surface of the optical cladding, which extends for a distance in front of and/or behind the region in which the defects are provided, is partially fused in a spot-like manner and/or by a longitudinal weld to the inner surface of the cover, in particular to the inner diameter of the cover. Thus, the fusion zone can be provided in a plurality of fusion areas (fusion section areas), in particular wherein the fusion areas are designed as partial sections. In experiments performed in connection with the present invention it has been found that even a partially fused region(s) may provide a secure attachment of the cover to the optical cladding. The design of the fused region(s) depends in particular on the method of fusing the optical cladding to the cover.

Also, there may be a non-fused region between the optical cladding and the cap where no defect is provided, and/or where the cap is not fused to the cladding. The fusion zone between the cover and the optical cladding may be provided via a fusion zone (partial zone), which may in each case be designed to apply all and/or part of the surface of the fusion. The fused part zone particularly enables a secure attachment of the cover to the optical cladding, wherein according to the invention the design of the fused zone and/or the fused region(s) may depend on the fusing method.

Further, in the fusion region where the cladding is fused to the cover (fusion region), it is preferable that the cladding and the cover are firmly bonded, in particular, firmly bonded in a material-locked manner. In particular, no additional adhesive is required to securely bond the cover and cladding in the fused area. The cover is inseparably and/or inseparably linked and/or connected to the envelope due to the material locking manner of the combination of the envelope and the cover. Preferably, the cover cannot be detached from the cladding.

More preferably, the inner diameter of the core is between 100 μm and 1000 μm, preferably between 200 μm and 800 μm, more preferably between 300 μm and 700 μm, and in particular between 350 μm and 600 μm. These diameter ranges are particularly capable of guiding light and additionally provide for defects that may extend into the core. The defect may circumferentially surround the core such that the diameter must be sufficiently large with respect to the desired depth of the defect.

Since the cladding at least partially surrounds the core, the outer diameter of the cladding may be greater than the outer diameter of the core. The outer diameter of the cladding may be between 110 μm and 1200 μm, preferably between 250 μm and 850 μm, more preferably between 350 μm and 750 μm, and in particular between 400 μm and 650 μm.

In particular, the diameter of the core may be between 530 μm and 555 μm, in particular wherein the outer diameter of the cladding may be between 580 μm and 610 μm.

Alternatively or additionally, the outer diameter of the core may be between 380 μm and 410 μm, in particular wherein the outer diameter of the cladding may be between 420 μm and 450 μm.

Furthermore, the jacket thickness of the cladding may be between 1% and 40%, preferably between 5% and 20%, of the outer diameter of the core. Thus, the thickness of the cladding may depend on the outer diameter of the core.

In addition, a protective sheath may preferably be provided at the distal end of the waveguide. The protective sheath may be coupled to the cover. The protective sheath may also surround the optical cladding and/or core. Preferably, the protective sheath is designed such that light guided through the core cannot be transmitted via/on the protective sheath. In particular, the protective sheath may comprise at least one buffer layer and/or an outer sheath, preferably the buffer layer being adjacent to the optical cladding of the core. The outer jacket may be designed as a mantle at least around the core.

The cushioning layer may also be positioned adjacent to the cover and/or between the cover and the core, preferably in the non-fused region. Alternatively or additionally, the buffer layer may preferably be at least indirectly adjacent to and/or abutting the outer jacket, and/or the outer jacket may preferably be at least indirectly adjacent to and/or abutting the outer jacket.

The protective sheath and/or the outer sheath can also be designed as a preferably extruded plastic coating.

Additionally, an outer sheath may be coupled to the cover.

According to another preferred embodiment of the invention, the device may be characterized in that the protective sheath and/or the outer sheath (also called mantle) is at least partially removed at the distal end of the waveguide to expose the core and its optical cladding. Thus, the distal end of the waveguide can be designed by removing the protective sheath, in particular so that the core and its optical cladding can face the cover.

Preferably, the defect may extend into the cladding, preferably to expose the core, and/or into the core. The depth and/or width, in particular the extension in the cladding and/or in the core, can be designed in the following manner depending on the form of the defect: so that light transmitted and guided along the core can be decoupled or coupled out and can thus be sent out or emitted via the optical cladding and the cover. The light is reflected and/or refracted by the defect, wherein the form of the defect may be designed such that a greater percentage of the light may be refracted or reflected. The defect may reduce the jacket thickness of the cladding within the defect, and thus may alter the light propagation behavior.

Furthermore, the defect may be designed as a groove, in particular a spiral groove, which is adapted to refract and/or reflect light propagating in the core and its optical cladding in a substantially radial direction.

The grooves may include at least two helical grooves extending through the optical cladding into the core. Alternatively or additionally, the slot may extend at least into the cladding, preferably into the core. The depth and/or width of the slots may vary, particularly wherein the depth and/or width of the slots may increase in a direction toward the distal end of the core.

The successive grooves of each helical groove may alternate along an outer surface extending longitudinally from the core and its optical cladding.

In another preferred embodiment of the present invention, the defect may include at least one circular groove and/or elliptical groove and/or annular groove. The circular groove may circumferentially surround the core and the cladding.

In addition, the defect may further include at least one longitudinal groove. Punctiform and/or interrupted defects/grooves and/or recesses in the form of spherical caps are also possible. The form of the defect/groove may vary. Different combinations of the defect/groove forms are also possible.

The defect/slot is designed such that light propagating within the core can be emitted or coupled out of the core and cladding. The light is reflected and/or refracted at the defect/groove boundary surface. The greater the depth and/or width of the defect/groove, the greater the percentage of light intensity that "leaves" (emits) the core and cladding, since the light refracts particularly at the defect/groove boundary surface.

The defects may also be arranged in a patterned structure and/or in a different form. In particular, the pattern of the defect is designed such that a substantially uniform emission profile is achieved over the length of the area in which the defect is located.

In a further preferred embodiment of the invention, the depth and/or width and/or length of the defect, preferably the depth and/or width and/or length of the groove, increases in a direction towards the distal end of the core. In particular, the depth and/or width and/or length, preferably the depth and width, of the defect may be increased by up to 1000%, preferably by up to 800%, more preferably by up to 400%, in particular relative to the minimum depth and/or width and/or length of the defect.

Preferably, the maximum depth and/or width of the defect is between 2 and 4 times the depth and/or width of the minimum depth and/or width of the defect.

In particular, the depth and/or width of the defect may increase up to 400 μm, preferably up to 300 μm, more preferably up to 200 μm, and/or the depth and/or width of the defect may vary between 1 μm and 400 μm, preferably between 10 μm and 200 μm.

The increase in the depth and/or width of the defect particularly allows to ensure a substantially uniform and/or equal emission profile of the laser light.

Since a higher amount and/or percentage of laser intensity has to be emitted via the defect, in particular by refraction on the boundary surface, the depth and/or width of the defect increases in the direction towards the distal end of the core. For example, 1% to 10% of the percentage of laser intensity is emitted at the "first" defect portion is sufficient. This may lead to the following fact: after the laser has passed the "first" defect, the laser intensity is reduced. If the same amount of laser light is expected to be emitted at the "second" defect, the expected percentage of laser light intensity to be sent out must be higher. This may be achieved by increasing the width and/or depth of the defect.

The energy density generated along the area where the defect is located can be controlled by varying and/or customizing the size, placement and/or number of the defects, particularly the slots. Adjusting the overall size and geometry of the defect will in particular directly affect the amount of light energy leakage and/or radial light energy dissipation, the energy density transmitted along the area where the defect is located, the direction of the light energy, and/or the power energy escaping from the distal end of the core.

In a further preferred embodiment of the invention, the material of the core comprises fused silica, in particular quartz glass. Furthermore, the core may comprise an optical fiber, which may comprise and/or consist of quartz glass. Alternatively or additionally, the material of the cladding surrounding the core may comprise fused silica, in particular quartz glass.

Furthermore, the material of the core, in particular the fused silica material of the core, may be different from the fused silica material of the cladding, preferably to ensure a different refractive index.

The fused silica material of the cladding and/or core may be doped, in particular to ensure a different refractive index. In particular, the cladding may be doped with fluorine and/or boron. Alternatively or additionally, the core may be doped with germanium and/or phosphor. Preferably, the cladding is doped with fluorine, wherein the core is undoped. The doping may enable the refractive index of the cladding to be less than the refractive index of the core, such that the propagation behavior of light towards the core at the boundary surface is characterized by the transmission (return) of light in the core. Thus, the material of the core and the material of the cladding may be dielectric materials, such that the core (with the optical fiber) and the cladding may be dielectric waveguides (non-conductive waveguides).

The preferred material for the cladding and core, fused silica, can exhibit reasonably good optical transmission over a wide range of wavelengths. In addition, silica is also relatively chemically inert. In particular, silica is non-hygroscopic (silica does not absorb water). As already mentioned, the silica glass can be doped with various materials, wherein one purpose of the doping, in particular one of the core doping, is to increase the refractive index (for example, with germanium dioxide (GeO) 2) And/or alumina (Al)2O3) And another purpose of the doping (in particular of the cladding) is to reduce the refractive index (for example, with fluorine and with doping)/or diboron trioxide (B)2O3))。

The material of the cover may include glass and/or fused silica. This material of the cover may ensure a fluid-tight and/or liquid-tight connection between the cladding, which in particular comprises fused silica as material, and the cover. Thus, glass and/or fused silica, which are the materials of the cladding and the cap, may be welded and/or fused in the fused region.

The length of the area where the defect, preferably a groove, is provided may be between 0.1mm and 30mm, preferably between 1mm and 15mm, more preferably between 3mm and 4 mm. The length of the area provided with the defect, preferably a groove, corresponds in particular to the length of the light emission and/or transmission. Since the laser emission profile is not particularly relevant for so-called "front emission", the efficiency of use of the device is increased. Furthermore, the emission of the laser light may be circumferentially around the core, preferably 360 degrees around the core.

Further, the distal end of the core may be terminated by a reflector. The reflector may be formed by the distal end of the core and/or the cladding. The core and/or cladding may terminate in and/or lead into the reflector.

The reflector may have a conical shape, wherein the cone angle of the reflector designed as a reflection cone may additionally be about 60 degrees.

The shape of the reflector may influence the refractive behavior of the laser light. The laser light may be refracted or reflected at the boundary surface of the reflector. Thus, the geometry of the reflection cone (reflector) can be designed such that: at least 20%, preferably at least 50% of the intensity of the laser light emitted and/or transmitted out of the laser light via the reflection cone and/or impinging on the reflector is reflected, in particular by total reflection. The larger the cone angle, the higher the percentage of laser light reflected may be. Additionally or alternatively, the reflector may have a conical reflective conical surface, wherein the cone angle of the reflective cone is about 68 to 90 degrees.

The term "reflector" should therefore be understood in particular in a broad sense, so that the reflector may also be designed to at least partially refract light.

Preferably, the proximal end of the aperture of the cover is preferably provided with the following sections in the non-fused area: the segments have an increased inner diameter corresponding to the outer diameter of the buffer layer and/or the outer diameter of the core. The buffer layer may be part of a protective sheath, wherein the buffer layer may surround a cladding and/or core in the section having an increased inner diameter corresponding to an exterior of the buffer layer.

Furthermore, at the proximal end of the cap, a section with an increased inner diameter is glued to the at least one buffer layer and/or the core and/or the cladding. The cushioning layer may be disposed at the proximal end of the cover, and may further be disposed adjacent to the cover. An adhesive may additionally be provided, in particular to ensure a smooth transition between the outer surface (in particular the outer diameter) of the cap and the outer surface (in particular the outer diameter) of the outer jacket. An adhesive may connect the cover to the outer sheath. In addition, an adhesive may attach the cushioning layer to the inner surface of the cover.

In particular, the outer surface of the cover is glued to the outer sheath, wherein the inner surface of the cover may be at least partially glued to the buffer layer, the core and/or the cladding and/or the outer sheath.

The outer surface (in particular the outer diameter) of the cap, and/or the outer surface (in particular the outer diameter) of the protective sheath, and/or the outer surface (in particular the outer diameter) of the outer sheath, may represent a smaller outer surface (in particular the outer diameter). In particular, the outer diameter of the cap may be larger or smaller than the outer diameter of the protective sheath and/or the outer diameter of the outer sheath.

Furthermore, an adhesive may be arranged between the outer sheath and the cover and/or in said section to connect the cover to the cladding and/or the core, preferably in the non-fused region.

In particular, the inner surface of the hole of the cover is provided with an antireflective coating. Thus, the propagation behavior of the laser light can be influenced in the hole of the cover in the following manner: in particular, so that the laser light is transmitted to the area where the defective portion is provided.

In particular, the defect, preferably a groove, is produced by means of CO2Laser beam cutting produced by: rotating the core and its optical cladding about its longitudinal axis relative to the laser beam, and rotating the laser beam and/or the core and its optical cladding with the coreIs moved axially about the longitudinal axis of the core in a synchronized manner. The creation of such a defect is easy to handle and a well defined defect can be formed to manipulate the propagation behavior of the laser in an efficient manner.

In order to maximize the light output density, this spatial distance of the defect/groove in the longitudinal direction must be minimized. However, this will in particular lead to a rather rapid change in the depth of the defect/groove and a rather steep flange angle and a defect/groove surface oriented almost perpendicular to the direction of light propagation in the optical fiber. A defect/groove surface oriented almost perpendicular to the direction of light propagation in the fiber will in particular cause unwanted back scattering of laser light into the fiber and eventually back to the source.

Optimization of the optical output density may in particular be achieved by providing a second or more additional helical grooves along the longitudinal axis of the optical fiber, in order to generate the desired more uniform and dense radiation in particular along the longitudinal axis of the core through which the grooves extend into the core, successive ones of the respective helical grooves alternating along the longitudinally extending outer surface of the core and its optical cladding.

Preferably, the additional second or more helical grooves alternate with the first helical grooves on the outer surface of the core and its optical cladding along the longitudinal axis of the core, thereby creating a more uniform and dense distribution of light emitted by the grooves, such that the laser output can be concentrated over a shorter length of the bare distal end of the optical fiber core and its optical cladding despite the flank angles of the individual grooves required to refract light propagating within the optical fiber core in a generally radial direction.

In embodiments where two or more helical flutes are provided, the start of the helical flutes are preferably angularly offset in the circumferential direction of the core by 360 degrees divided by the number of flutes in the circumferential direction of the core.

This enables the emission profile of the laser light emitted at the boundary surface of the groove to be uniform.

In another preferred embodiment, the two or more helicoidal grooves may have substantially the same pitch angle value with respect to the longitudinal axis of the core, and may further extend in the same direction. Such a geometry of the helical groove may enable a uniform laser emission profile and is additionally easy to produce according to a symmetrical and/or regular geometry of the groove.

Alternatively or additionally, two or more helical flutes may have substantially the same helix angle value, wherein they extend in opposite directions such that successive flutes of a respective pair of helical flutes cross each other.

The double helical and/or spiral configuration of the grooves may ensure an even and/or complete treatment of the vein and/or vessel, in particular even a treatment of about 360 degrees. The double helical groove configuration comprises two identical helices, in particular having the same axis, which axis differs by a translation along the axis.

Furthermore, the helix angle value of the helical groove relative to the longitudinal axis of the core is particularly selected to be about 60 degrees. In experiments conducted in connection with the present invention, it has been found that a helix angle of the helical flutes of about 60 degrees achieves a uniform emission profile, which is particularly desirable and/or advantageous for use in "phlebotomy" medical applications.

The depth of the defect/groove preferably increases in a direction towards the distal end of the core to obtain a more uniform light distribution.

Furthermore, the invention relates to a method for manufacturing a device for the treatment of tissue of a body according to one of the above-mentioned embodiments.

In the method of the invention, the outer surface of the optical cladding is fused to the inner surface of the cap, in particular the inner diameter of the cap, in the region at least partly between the defects. Alternatively or additionally, the outer surface of the optical cladding, which extends a distance in front of and/or behind the region where the defect is provided, is fused to the inner surface of the cap, in particular to the inner diameter of the cap.

It will be appreciated that references made to the previous comments regarding the apparatus of the present invention also apply in the same manner to the process and/or method of the present invention. To avoid unnecessary explanation, reference is made to the preceding remarks of preferred embodiments of the device of the invention.

The fusion of the invention may ensure a material-locking connection between the cladding and the cover. Thus, the safety for the patient during medical treatment by the device is improved. The cap cannot be pulled out of the cladding and/or core during treatment of the tissue of the body, particularly when the device is in a blood vessel and/or vein.

The vacuum according to the invention is to be understood in particular as a partial vacuum which can be achieved in a laboratory, wherein a negative pressure is present in the partial vacuum. In particular, according to the present invention, it is understood that "vacuum" is low vacuum up to ultra-high vacuum.

Preferably, the light diffuser, more preferably the cover and/or the cladding, is heated at least in the area to be fused, in particular such that the cover is at least partially collapsed and fused to the optical cladding and/or the core. Before and/or during heating, a vacuum may be applied to the still open end of the cover, in particular such that the cover may collapse to the cladding and/or core in a vacuum environment.

The material of the lid, in particular glass and/or fused silica, may be fused to the cladding and/or core as a result of heating the lid and/or cladding. After the cover collapses in the fused area, the material of the cover and cladding and/or core are firmly bonded. These regions may extend circumferentially and/or in a 360 degree manner around the core and/or be arranged partially, i.e. in the fused region (partial region). The design of the fusion zone varies in particular according to the zone that has been heated. The region in which the cover and/or the cladding is heated is in particular the region in which the cover is collapsed onto the cladding and may therefore be a so-called "fusion region" in which the cover is connected to the cladding and/or the core in particular in an inseparable manner.

In a further preferred embodiment of the invention, a portion of the protective sheath from the distal end of the waveguide is removed, preferably with a length longer than the length of the section of the core and its cladding to be provided with the defect, in particular the slot.

Alternatively or additionally, the outer sheath of the protective sheath is removed, in particular the length substantially corresponding to the length of the enlarged inner diameter portion at the proximal end of the cap. The removal of the protective sheath and/or the outer sheath of the protective sheath may in particular be performed before fusing the cover to the cladding. The sheath and/or outer sheath may also be removed after fusing the cover to the cladding and/or core. Removal of the protective sheath enables the cover to be disposed over the cladding. A protective sheath may be provided for protecting the core during use and/or transport.

Furthermore, according to the method of the invention, a reflector may be provided at the distal end of the bare core and its cladding, in particular by removing material of the core and/or the cladding. The removal of material of the core and/or the cladding may be performed before fusing the lid to the cladding.

The removal of the material of the core and/or the cladding may be performed in such a way that the reflector is designed as a reflective cone. The cone angle of the reflection cone may vary between 60 degrees and 90 degrees. The geometry of the reflecting cone of the reflector may further influence the refraction and/or reflection behavior of light impinging on the reflector. Reflection, in particular total internal reflection, or refraction of the laser light is to be caused. It may be the case that both reflection and refraction occur with respect to the angle of attack and/or angle of incidence of the laser light.

In addition, it is possible to use CO2The laser beam and/or plasma beam cuts the defect (preferably a slot) through the optical cladding, particularly into the core to form the defect (preferably a slot).

The size and/or pattern of the defect may vary along the length of the core. It may be that the first type of defect extends only into the cladding, wherein the other type of defect extends into the cladding as well as into the core. Both types of defects can be detected by using CO2The laser beam cuts the defect portion.

The core and its optical cladding may be rotated relative to the laser beam about the core and its longitudinal axis, preferably so as to cut the defect. Furthermore, the laser beam and/or the waveguide and the core as well as the core and its optical cladding are moved axially along the longitudinal axis of the core in a manner synchronized with the rotation of the core. The spiral groove of the defective portion may be provided in this manner.

After providing the defect in the cladding and/or the core, the cap may be slid over the area where the defect of the core is provided and over the optical cladding. Preferably, the cover is also slid onto the short length of the buffer layer from which the outer layer/sheath of the protective sheath has been removed. Thus, the buffer layer may surround the core and/or the cladding before the cover is provided. Alternatively, the buffer layer may be provided after the cap is slid over the cladding and/or core. In another embodiment, there is no buffer layer, wherein the cap may be connected to the outer layer/sheath of the protective sheath after fusing the cap to the cladding.

In particular, after fusing the cover to the core and/or the cladding, the proximal end of the cover may be glued to the protective sheath, preferably to the buffer layer and/or the outer sheath.

Preferably, the cover may be glued as follows: inserting a diffuser and/or device comprising a cap (with the distal end of the waveguide received in the cap) through an annular seal at the top of a vacuum sealed container having a bottle filled with adhesive at its bottom; and applying at least a partial vacuum within the container, and/or introducing the diffuser and/or device until after the distal end of the cap enters the adhesive-filled bottle.

The vacuum can be released from the container such that the adhesive from the bottle is drawn into one or more, preferably any, of the gaps between the cap, the cushioning layer, and the unfused proximal portion of the core and its cladding. Alternatively or additionally, the adhesive is shaped and preferably bridges the proximal portion of the cap and the outer layer/sheath of the protective sheath and, more preferably, any adhesive that remains adhered to the outer surface of the cap is removed.

Thus, after fusing the cover to the cladding and/or core, the cover may be glued to the outer sheath of the protective layer. The gluing of the cap to the buffer layer and/or the outer sheath can be achieved by inserting the waveguide and the cap into a bottle filled with an adhesive.

Gluing of the cover to the outer sheath is a further possibility to connect the cover to the core. In addition, the adhesive between the outer sheath and the cover ensures that no liquid, in particular no blood, can reach the boundary between the core and the cladding and/or the cover. In particular, the cover is connected to the outer jacket in a liquid-tight and/or fluid-tight manner, so that no liquid can reach the inner surface of the cover.

Furthermore, the smooth transition of the cover to the outer sheath is arranged such that damage to the tissue of the body during or after treatment of the tissue of the body can be avoided due to the absence of sharp edges and/or sharp corners at the proximal end of the cover.

Preferably, the invention relates to a device for treatment of tissue of the body by means of a light diffuser for irradiating the tissue circumferentially and endoluminally by laser energy, said diffuser being connected at its proximal end to a source of laser energy via a flexible waveguide comprising an optical fiber core covered by an optical cladding having a refractive index smaller than the refractive index of the core, and a protective sheath, the distal end of the waveguide with its protective sheath being at least partially removed to expose the core and its optical cladding, and the distal end of the waveguide being provided with a groove adapted to refract and/or reflect light propagating in the core and its optical cladding in a substantially radial direction, a cover transparent to the laser light closing the distal end of the core and its optical cladding in a fluid-tight and/or liquid-tight manner, characterized in that said groove comprises at least two helical grooves, the grooves extend through the optical cladding into the core, successive ones of the individual helical grooves alternating along a longitudinally extending outer surface of the core and its optical cladding.

In particular, the device is characterized in that the starting point of the helical groove is angularly offset in the circumferential direction of the core by an angle of 360 degrees divided by the number of grooves.

More preferably, the device is characterized in that the two or more helical flutes have substantially the same helix angle value with respect to the longitudinal axis of the core and extend in the same direction.

Furthermore, the device may be characterized in that two or more helical flutes have substantially the same helix angle value, but extend in opposite directions such that successive flutes of a respective pair of helical flutes cross each other.

Furthermore, the device is characterized in particular in that the helix angle value of the helical groove relative to the longitudinal axis of the core is chosen to be approximately 60 °.

Alternatively or additionally, the device may be characterized in that the depth of the slots increases in a direction towards the distal end of the core.

Preferably, the device is characterised in that the outer surface of the optical cladding is fused to the inner diameter of the cap in the region between the grooves.

Preferably, the device is characterized in that the outer surfaces of the optical cladding, which extend a distance in front of and behind the groove region, are fused to the inner diameter of the cap.

More preferably, the device is characterised in that the distal end of the core is terminated by a reflector.

In particular, the device is characterized in that the reflector has a conical shape, the cone angle of the reflection cone being about 60 degrees.

The device is further characterized in that the reflector has a conical reflective conical surface, the conical angle of the reflective cone being approximately 68 to 90 degrees.

Alternatively or additionally, preferably, the device is characterized in that the protective sheath comprises: at least one buffer layer adjacent to the optical cladding of the core, and an outer jacket.

The device is characterized in that the proximal end of the bore of the cover is provided with the following sections: the section has an increased inner diameter corresponding to the outer diameter of the cushioning layer.

Preferably, the section with the increased inner diameter at the proximal end of the cap is glued to the at least one buffer layer, the glue additionally providing a smooth transition between the outer diameter of the cap and the outer diameter of the outer sheath.

Preferably, the inner surface of the aperture of the cover is provided with an anti-reflective coating.

In particular, the tank is made by2Laser beam cutting produced by: rotating the core and its optical cladding relative to the laser beam about its longitudinal axis, and bringing the laser beam and/or the core and its optical cladding into contact withThe rotation of the core is moved axially along the longitudinal axis of the core in a synchronized manner.

Further, it is clear that in the intervals and ranges described above, all intermediate intervals and individual values are included and are considered to be crucial for the invention, even if these intermediate intervals and individual values are not specifically provided.

Further features, advantages and application possibilities of the invention are provided in the following description of exemplary embodiments shown in the drawings and in the drawings themselves. All the described and/or illustrated features form the object of the invention by themselves or in any combination, irrespective of the subject-matter of the subject-matters of these features in the claims and their dependencies.

Drawings

Preferred embodiments of the device according to the invention are shown in the accompanying drawings, in which:

figure 1 shows a first embodiment of the diffuser device of the present invention in a schematic cross-sectional side view;

FIG. 2 shows a detail of the markings in FIG. 1;

FIG. 3 illustrates non-limiting details of a trough section of a diffuser device and a method of cutting the trough;

figure 4 shows a second embodiment of the diffuser device of the present invention in a schematic cross-sectional side view;

FIG. 5 shows a detail of the markings in FIG. 4;

FIG. 6 shows a schematic cross-sectional view of the distal end of a diffuser according to another embodiment of the device of the present invention;

FIG. 7 shows a schematic cross-sectional view of the distal end of a diffuser according to another embodiment of the device of the present invention;

FIG. 8 shows a schematic cross-sectional view of the distal end of a diffuser of another embodiment of the device of the present invention;

fig. 9 shows a schematic perspective side view of a core according to another embodiment of the device according to the invention;

fig. 10 shows a schematic perspective side view of a core according to another embodiment of the device according to the invention;

fig. 11 shows a schematic perspective side view of a core according to another embodiment of the device according to the invention;

FIG. 12 shows a schematic cross-sectional view of the distal end of a diffuser of an inventive device according to another embodiment;

FIG. 13 shows a cross-sectional side view of the core and cladding;

FIG. 14 shows a schematic perspective side view of a core and cladding according to another embodiment of the apparatus of the present invention; and

fig. 15 shows a schematic process scheme of the inventive method.

Detailed Description

In the drawings, which are merely schematic and sometimes not to scale, identical or similar parts and components are provided with the same reference signs, corresponding or separable characteristics and advantages being obtained even if not repeatedly described.

In fig. 1, a first embodiment of an elongated diffuser device 13 is shown, which is connected at its proximal end to a laser source 10 via a waveguide 12. Waveguide 12 is interrupted by a dashed line to indicate that it may have any length required for a particular application.

The waveguide 12 comprises in a conventional manner an optical fiber core 1 and an optical cladding 2 visible in fig. 2, which has a refractive index smaller than that of the core 1, so that light irradiated into the core 1 by the source 10 can be transmitted to the diffuser device 13 via the waveguide 12 with minimal losses. The optical cladding 2 of the core 1 is covered by an inner or buffer layer 3 (e.g., a "hard coat") and at least one outer layer 14 of a protective sheath 25.

The diffuser device 13 has an active region marked with a dash-dot line in fig. 1 and shown in more detail in fig. 2. In this region, the buffer layer 3 and any of the outer layer/outer jacket 14 of the protective jacket 25 are removed, leaving only the optical fiber core 1 and its optical cladding 2. The active region is adapted to redirect light propagating along the longitudinal axis of the waveguide 12 in a generally radial direction.

At least the active region (see dotted lines) is enclosed in a cover 7 which is transparent to the laser light and has an inner diameter which substantially corresponds to the outer diameter of the core 1 and its cladding 2.

As can be seen in particular from the embodiments shown in fig. 1 to 3, within the active region (see dashed line), the optical core 1 and its cladding 2 comprise two helical grooves 4, 5 which start at respective offset starting points around the circumference of the optical core 1 and its cladding 2. Slots 4, 5 are cut through the cladding 2 and into the outer circumference of the core 1. The number of slots 4, 5 is of course not limited to two slots 4, 5, which are mentioned only for exemplary purposes. In general, the starting points of the helical grooves 4, 5 are preferably angularly offset in the circumferential direction of the core 1 by 360 degrees divided by the number of grooves 4, 5 in the circumferential direction of the core 1.

As can be seen from fig. 2, the offset starting points of the respective helical grooves 4, 5 result in the grooves 4, 5 alternating along the length of the outer circumference of the core 1 and its optical cladding 2.

At least some of the circumferential portions of the core 1 and/or the cladding 2, which extend between the slots 4, 5 and short sections of the core 1 and the cladding 2 at both ends of the slot sections along the length of the cover 7, are fused to the inner diameter of the cover 7, thus resulting in a reliable support for the core 1 and the cladding 2 within the active region (see dash-dotted line in fig. 1).

The slots 4, 5 at the outer surface of the core 1 and its cladding 2 have a predetermined shape depending on the intended direction and concentration of radial radiation caused by the slots 4, 5, which causes redirection by reflection of light passing through the core 1 of the waveguide 12 into the radial direction and/or by refraction of this light at the interface formed between the slots 4, 5 and the inner diameter of the cover 7.

The distal portions of the core 1 and the cladding 2 are terminated by conical reflectors 6, thereby avoiding any axial emission of light energy that is not dissipated through the respective slots 4, 5 on the first pass through the section of the core 1 where the slots 4, 5 are provided. The cone angle of the reflector 6 may be about 60 degrees for lateral reflection of the light energy, or about 68 to 90 degrees for reflection of the light energy back into the section of the core 1 where the slots 4, 5 are provided.

The inner bore of the cap 7 has an enlarged inner diameter portion 8 at its proximal end, which is slightly larger than the outer diameter of the buffer layer 3 of the protective sheath 25. Small gaps 11, 15 (shown in fig. 4) are left between the distal end of the enlarged diameter portion 8 and the distal end of the cushioning layer 3 and between the distal end of the outer layer 14 of the protective sheath 25 and the proximal end of the cap 7, respectively. These gaps are filled with an adhesive 9 which also penetrates into the space between the outer circumference of the buffer layer 3 and the inner diameter of the cap 7 and can penetrate within a short distance into the cladding 2 between the outer diameter of the cap 7 and the inner diameter of the cap 7 without being fused thereto, so as to mechanically fix the cap 7 to the buffer layer 3 of the protective sheath 25 and the outer layer 14 of the protective sheath in a reliable and fluid-tight and/or liquid-tight manner.

By benefiting from reduced pressure caused by cooling of air or other gaseous medium in the cap 7, or other means set forth hereinafter, after fusing the active region to the inner diameter, the adhesive 9 penetrates into the space between the buffer layer 3 and the enlarged diameter portion 8 and into the space between the optical cladding 2 of the core that is not fused to the inner diameter of the cap 7 and any portion of the core 1.

In this way and in addition to fusing the portion of the cladding 2 of the active region (see dotted line in fig. 1) to the inner diameter of the cap 7, an increased stability of the device 17 and/or the diffuser 13 is obtained.

As shown in fig. 1, the glue 9 may also extend over the outer layer 14/outer jacket 14 of the protective jacket 25, thereby mitigating any step (step) or any difference between the outer diameter of the cover 7 and the outer diameter of the outer layer 14/outer jacket 14 of the protective jacket 25.

In fig. 3, a part of the active area (see dash-dot line) in fig. 1 is shown in more detail. As can be seen from fig. 3, the flank angle or helix angle α of the flutes 4, 5 is preferably about 60 degrees, and is preferably produced by: the waveguide 12 and the core 1 and its optical cladding 2 are rotated and the active part (see dotted line) is subjected to a laser beam 20, preferably CO 2Laser beam) at an angle of about 70 degrees to the longitudinal axis 16 of the core 1, thereby cutting the grooves 4, 5 into the outer surface 19 of the optical cladding 2 and into the core 1 as shown in fig. 3.

During the rotation of the core 1, the laser beam 20 is continuously moved along the length of the active region in a manner synchronized with the rotation of the core by the movement of the laser beam 20 and/or the wave of the waveguide 12 and the core 1 and its optical cladding 2.

Furthermore, during the movement of the laser beam 20 from the proximal end to the distal end of the core 1 and/or the duration of exposure of the core 1 and the optical cladding 2 to the laser beam 20, the power of the laser beam 20 may increase such that the depth of the grooves 4, 5 increases towards the distal end of the active region.

The two grooves 4, 5 or any additional grooves are preferably cut in a separation step after each other.

It is of course also possible to keep the core 1 stationary and to rotate the means generating the laser beam 20 or a set of suitable optical mirrors and beam deflection devices around the core 1. Furthermore, the laser beam 20 may be directed onto the optical cladding 2 of the core 1 by a set of suitable optical mirrors and beam deflection devices.

Instead of using a laser beam 20, a plasma beam may also be used for cutting the grooves 4, 5.

Upon heating the lid 7 and fusing the optical cladding 2 to the inner diameter of the lid 7, the air or other medium inside the lid 7 expands due to the high temperature and leaves the lid 7, and after fusing, the adhesive 9 is applied and partially sucked into the above-mentioned gap upon cooling the device, resulting in a low pressure inside the lid 7. Another method for applying the adhesive 9 will be described below.

The embodiment of the device shown in fig. 4 and 5 is similar to the embodiment shown in fig. 1 to 3, but differs therefrom in that: two or more helical flutes 40, 50 have substantially the same helix angle α value, but extend in opposite directions such that successive flutes 40, 50 of respective pairs of helical flutes 40, 50 intersect one another.

In the following, further embodiments of the proposed device 17 are described. The preceding description applies in particular correspondingly or additionally even if not repeated.

Fig. 6 shows the distal end of the device 17 and/or the diffuser 13 for treating the tissue of the body. In fig. 1, a device 17 and/or a diffuser 13 for the treatment of tissue of a body are shown. The device 17 and/or the diffuser 13 may be used for permanent occlusion of varicose veins, preferably in the lower extremities, and/or for medical applications of phlebotomy and/or for permanent occlusion of varicoceles and/or vascular malformations, and/or for use in cosmetic surgery, preferably laser-assisted lipolysis, and/or for tumour treatment by means of laser-induced thermal and/or photodynamic therapy. The device 17 and/or the diffuser 13 may be at least partially inserted into the tissue of the body, in particular into a blood vessel and/or vein.

The device 17 for treating tissue of a body has a light diffuser 13 which irradiates the tissue circumferentially and intraluminally by laser energy. Laser light is irradiated in the active region a. Said diffuser 13 is connected at its proximal end to the laser energy source 10 by a flexible waveguide 12 comprising an optical fiber core 1 covered by an optical cladding 2 having a refractive index smaller than that of the core 1.

In fig. 6, a waveguide 12 is shown, i.e. the distal part of the waveguide, having its core 1 and its optical cladding 2. A laser source 10 is shown in fig. 1.

Fig. 6 shows that a defect 18 is provided in the cladding 2 and/or the core 1, which defect is designed as a recess and is adapted to guide light, preferably to refract and/or reflect light propagating within the core 1 and/or its optical cladding 2 in a substantially radial direction.

The refractive index of the cladding 2 is smaller than that of the core 1 so that light propagates through the core 1. The defect 18 creates a boundary surface on which the laser light is refracted and/or reflected. These boundary surfaces may influence the propagation behavior of the laser light. Furthermore, on and/or through the defect 18, the laser light is (partially) transmitted out and/or coupled out, so that in particular a certain percentage of the laser light intensity can be transmitted and can "hit" the tissue of the body.

Furthermore, fig. 6 shows that a cover 7 is provided, which is transparent to the laser, closing the distal end of the core 1 and its optical cladding 2 in a fluid-tight and/or liquid-tight manner. The cover 7 may surround the cladding 2 and the core 1 at the distal end of the waveguide 12. The cap 7 may be inserted into the tissue of the body, wherein the laser light is transmitted via the cap 7. The refractive index of the cover 7 is dimensioned such that the laser light can pass through the cover 7, with respect to the refractive index of the core 1 and the cladding 2, to be emitted and/or coupled out through the diffuser 13. Furthermore, the cover 7 protects the core 1 and the cladding 2 from liquids in the tissue of the body, in particular blood. Also, the cap 7 may increase the stability of the distal end of the diffuser 13 inserted into the tissue of the body.

Fig. 6 shows schematically that the outer surface 19 of the optical cladding 2 is fused to the inner surface of the cover 7, preferably to the inner diameter of the cover 7, in the region a between the defects 18. The areas a between the defects 18 are fused to the inner surface 21 of the lid 7 in the following manner: such that the cover 7 is non-removably connected to the envelope 2.

Furthermore, the outer surface 19 of the optical cladding 2, which extends a distance in front of and/or behind the region a where the defect 18 is provided (with respect to the direction of light propagation in the core 1), may also be fused to the inner surface 21 of the cover 7, in particular to the inner diameter of the cover 7.

The cladding 2 is fused to the inner surface 21 of the cover 7 at least in one region (fused region 32). The fused region(s) 32 may be at least a portion of region a between defects 18 and/or at least a portion of region C in front of region a where defects 18 are disposed and/or at least a portion of region B behind region a where defects 18 are disposed.

Fig. 6 shows that at least a portion of the area B behind the area a where the defect 18 is provided is fused to the inner surface 21 of the cover 7.

Fig. 7 shows that the area C in front of the defect 18 is at least partially fused to the inner surface 21 of the cover 7.

Fig. 8 shows that the area C in front of the area a where the defect 18 is provided is at least partly fused to the inner surface 21 of the cover 7, wherein a fused area 32 is also provided in the area B behind the area a where the defect 18 is provided.

It must be understood that fig. 6, 7, 8 and 12 show the fused area 32 in schematic view, since the thickness of the fused area 32 is shown in an enlarged view.

In the figure, the region B relates to the region of the core 1 and/or the cladding 2 behind the region a in which the defect 18 is provided, wherein in particular the reflector 6 is not included in the region B.

In particular, the region C indicates a region in front of the region a where the defective portion 18 is provided. Region C may extend from the "start" of region a with respect to laser propagation to the proximal end of the cover 7 and/or the outer sheath 14, or region C may relate to a portion in front of region a where the defect 18 is provided.

A region C relating to a part of the region in front of the region a where the defective portion 18 is provided is shown in fig. 12. The region C relates to at least a portion/area/region preceding the region a where the defective portion 18 is provided.

The fused region(s) 32 may be located in region a, region B, and/or region C. It must be understood that the fused region(s) 32 may be at least a portion of region a, region B, and/or region C. In the fused region(s) 32, the outer surface 19 of the cladding 2 is fused to the inner surface 21 of the cover 7, in particular to firmly attach the cover 7 to the cladding 2.

Furthermore, fig. 12 shows a partial region of the area in front of the area a, which partial region is free of fused areas 32 (has non-fused areas), in particular for filling with the adhesive 9 to be attached to the outer sheath 14.

In particular, the outer surface 19 of the optical cladding 2 is fused continuously and/or circumferentially and/or completely to the inner surface 21 of the cover 7, in particular to the inner diameter of the cover 7, in the region a between the defects 18, and/or the outer surface 19 of the optical cladding 2, which extends a distance in front of and/or behind the region a where the defects 18 are provided, is fused continuously and/or circumferentially and/or completely to the inner surface 21 of the cover 7, in particular to the inner diameter of the cover 7 (which means in the region B and/or in the region C). Thus, the circumferential fusion of the cover 7 to the cladding 2 may be designed in a circumferential manner of 360 degrees.

Moreover, not shown in the figures, in the areas a between said defects 18, and/or in the areas B behind the areas a provided with defects 18 and/or in the areas C in front of the areas a provided with defects 18, the outer surface 19 of the optical cladding 2 may be fused, preferably in a punctiform manner and/or by longitudinal welds and/or by patterned structures, in part to the inner surface 21 of the cover 7.

Furthermore, the lid 7 is fused circumferentially and/or completely to the cladding 2 at least in a part of the regions a, B, C; and the combination of the lid 7 being partly fused to the cladding 2 at least in a part of the regions a, B, C is possible.

In particular, the cladding 2 is fused to the lid 7 in the following manner: so that the cladding 2 and the cover 7 are firmly bonded, i.e. in a material-locking manner. This may be provided at least in a portion of the regions a, B, C, i.e. in the fused region(s) 32.

Fig. 13 shows that the outer diameter 22 of the core 1 is between 100 μm and 1000 μm, and in particular between 350 μm and 650 μm. The outer diameter 23 of the cladding 2 may be between 110 μm and 1200 μm, and in particular between 400 μm and 650 μm. In the embodiment according to fig. 13, the jacket thickness 24 of the cladding 2 is between 1% and 40% of the outer diameter 22 of the core 1, in particular between 5% and 15% of the outer diameter 22 of the core 1. Preferably, the jacket thickness 24 of the cladding 2 is about 10% of the outer diameter 22 of the core 1.

Fig. 1, 12 and 4 show a protective sheath 25. A protective sheath 25 may be located at the distal end of the waveguide 12. The protective sheath 25 may comprise at least one buffer layer 3 and/or a sheath 14, also referred to as a mantle, adjacent to the optical cladding 2 of the core 1. The outer jacket 14 (mantle) may prevent cracking of the core 1 during use and transport of the waveguide 12. Furthermore, the protective sheath 25 and/or the outer sheath 14 (mantle) can be designed as a preferably extruded plastic coating.

In addition, the buffer layer 3 may be provided to the outer jacket 14. In fig. 1, an embodiment is shown comprising a buffer layer 3 as part of a protective sheath 25. In the embodiment according to fig. 12, the buffer layer 3 is not required.

The protective sheath 25 and/or the outer sheath 14 may be joined to the lid 7 as shown in fig. 1, 4 and 12.

Fig. 12 shows that the protective sheath 25 and/or its outer sheath 14 is at least partially removed at the distal end of the waveguide 12 to expose the core 1 and its optical cladding 2.

Fig. 6 shows that the defect 18 extends into the cladding 2, preferably so as to expose the core 1. In the embodiment shown in fig. 6, the "first" defect portion 18 (with respect to the direction of light propagation in the core 1) extends at least into the cladding 2. In addition, the defect 18 may also extend into the core 1, i.e. in particular into the outer circumference of the core 1. The form and depth of the defect 18 may affect the propagation behavior of the light. The light may be refracted on the boundary surface created by the defect 18. The laser light refracted on the boundary surface of the defect 18 can be transmitted through the cover 7.

Fig. 12 shows that the laser light (see dashed line) can be refracted at the boundary surface of the defect 18 and thus emitted and/or coupled out by the diffuser 13. Not shown in fig. 12, the laser light may also be reflected on the boundary surface of the defect 18.

In fig. 6, one type of defect 18 extends only into the cladding layer 2, wherein the other type of defect 18 extends into the core 1 and into the cladding layer 2.

Fig. 1 to 5 show that the defect 18 is designed as a groove which is adapted to refract and/or reflect light propagating within the core 1 and its optical cladding 2 in a substantially radial direction.

Fig. 3 shows that the grooves 4, 5 comprise at least two helical grooves 4, 5 extending through the optical cladding 2 into the core 1. The successive grooves 4, 5 of each helical groove 4, 5 alternate along the longitudinally extending outer surface 19 of the core 1 and its optical cladding 2.

The defect 18 designed as a groove can also have a different form, in particular a patterned structure.

At least one groove can be designed as a circular groove and/or as an oval groove 26, which is shown, for example, in fig. 9. Circular and/or elliptical slots 26 may circumferentially surround core 1. The circular and/or elliptical grooves 26 may extend into the cladding 2 and/or the core 1.

In fig. 10, it is shown that the at least one groove is essentially designed in the form of a spherical cap.

In fig. 11, at least one groove is designed as a longitudinal groove 27. The longitudinal grooves 27 may be arranged on the outer circumference of the core 1.

Also shown in fig. 11, at least one slot may be designed as an interrupted slot 28 comprising a portion without a slot.

Not shown, at least one of the grooves is a dotted groove forming defect 18. The dotted trenches may form a uniformly and/or non-uniformly patterned structure.

Not shown yet, different forms of grooves may be combined, so that the waveguide 12 may comprise an elliptical groove 26, a longitudinal groove 27 and/or a point-like and/or interrupted groove 28.

Fig. 6 shows that the depth 30 and the width 31 of the defect 18 increase in the direction of the distal end of the core 1. The increase in the depth 30 and/or width 31 of the defect 18 may be designed such that the percentage of laser light that is refracted at the defect 18 and thus emitted by the diffuser 13 may be affected. For example, the depth 30 and/or width 31 of the defect 18 increases in the direction of the distal end of the core 1 due to the fact that: the "first" defect 18 requires a smaller percentage of laser light to refract than the subsequent defect 18. In particular, the depth 30 and/or the width 31 may be increased such that a substantially uniform emission profile may be achieved, in particular over the length 29 of the area a in which the defect 18 is provided.

Not shown, the length of the defect 18 may increase in the direction of the distal end of the core 1.

In particular, the depth 30 and/or width 31 and/or length of the defect 18 may be increased by up to 1000%, preferably by up to 800%, more preferably by up to 400%, in particular relative to the minimum depth 30 and/or minimum width 31 and/or minimum length of the defect 18. Preferably, the maximum depth 30 and/or maximum width 31 and/or maximum length of the defect 18 may be about 2 to 4 times the minimum depth 30 and/or minimum width 31 and/or minimum length of the defect 18.

Fig. 12 shows a core 1 comprising fused silica, in particular quartz glass, as material. The core 1 may comprise an optical fiber, which may comprise fused silica/quartz glass as a material. The cladding 2 may also comprise fused silica, in particular quartz glass, as material. The refractive index of the cladding 2 is different from the refractive index of the core 1, wherein the refractive index of the core 1 is larger than the refractive index of the cladding 2. This may be achieved in particular by doping the material of the core 1 and/or the material of the cladding 2. In the embodiment shown in fig. 12, the fused silica material of the cladding layer 2 is doped with fluorine.

In a further embodiment, not shown, the core 1 may additionally or alternatively be doped with germanium.

The fused silica material of the core 1 may be different from the fused silica material of the cladding 2, in particular to achieve a different refractive index.

Furthermore, in the embodiment shown in fig. 6, the length 29 of the area a provided with the defect 18 may be between 0.1mm and 30mm, and in particular between 3mm and 4 mm. The length 29 of the area a where the defect 18 is disposed may affect the emission profile of the laser light. In particular, the laser light is not only sent out or coupled out through the front/outer end (for efficient use of the laser, no front emission).

Fig. 9 to 11 show that the distal end of the core 1 is terminated by a reflector 6. The reflector 6 may be formed by the distal end of the core 1 and/or the cladding 2. In particular, the reflector 6 comprises the same material as the core 1 as the material, wherein the core 1 can additionally open into the reflector 6.

Further, fig. 9 to 11 show that the reflector 6 has a conical shape, wherein the cone angle is less than 90 degrees. In particular, the cone angle may be about 60 degrees or about 68 to 90 degrees. Depending on the form of the reflection cone, the laser light may be refracted and/or reflected at the boundary surface of the reflector 6. The reflection or refraction is also affected by the angle of incidence of the laser light striking the boundary surface of the reflector 6. Thus, in a symbolic sense, the reflector 6 may act as a mirror and/or allow laser light to be emitted on the distal end of the cover 7.

Therefore, the term "reflector" should preferably be understood in a broad sense, wherein the reflector 6 may also refract light according to cone angle, angle of incidence of light, etc.

Fig. 12 shows in a schematic view the laser light impinging on the boundary surface of the reflector 6 (see dash-dot line). In order to visualize the reflection and/or refraction of the laser light according to the cone angle of the reflector 6, two forms of the reflector 6 are shown. The reflector 6 having a larger cone angle may cause reflection of light (dotted line), wherein the laser light is refracted at the boundary surface of the reflector 6 having a smaller cone angle (dotted line).

Fig. 1 shows that the proximal end of the bore of the cover 7 is provided with a section 8 having an increased inner diameter corresponding to the outer diameter of the cushioning layer 3. The increased inner diameter of the section 8 may be designed such that the cover 7 may be adjoined to the outer sheath 4, in particular by means of an adhesive 9.

Fig. 12 shows that the proximal end of the cover 7 is provided with the following sections: said section having an increased inner diameter corresponding to the outer diameter 22 of the core 1. This section with the increased inner diameter of the cap 7 is filled with an adhesive 9, in particular to further connect the cap 7 to the outer sheath 14 and/or to provide a smooth transition between the outer surface of the cap 7 to the outer surface of the outer sheath 14.

Furthermore, in fig. 1, a section 8 with an increased inner diameter of the proximal end of the cover 7 is shown glued to the at least one cushioning layer 3. Furthermore, the glue 9 may be arranged to achieve a smooth transition between the outer surfaces of the caps 7, in particular between the outer diameters of the caps 7. In addition, a smooth transition from the cover 7 to the outer sheath 14 of the protective sheath 25 may also be provided.

In fig. 12, it is shown that the outer sheath 14 may be glued to the cover 7 at the proximal end of the cover 7 by means of an adhesive 9. The cover 7 also has an enlarged diameter at the proximal end for connection with the glue 9 and to be abutted to the protective sheath 25, in particular to the outer sheath 14 (also called mantle).

Not shown is that the inner surface 19 of the hole of the cover 7 is provided with an anti-reflective coating, in particular for influencing the light propagation behavior, in particular for increasing the efficiency of the light emission profile of the laser light.

In addition, in fig. 3 it is shown that the defect 18 (preferably the groove 4, 5) is created by means of CO in the following manner2The laser beam 20 cuts to produce: the core 1 and its optical cladding 2 are rotated relative to the laser beam about its longitudinal axis 16 and the laser beam 20 and/or the core 1 and its optical cladding 2 are moved axially along the longitudinal axis 16 of the core 1 in synchronism with the rotation of the core 1.

Fig. 3 shows in a schematic view that the laser beam 20 can strike the core 1 at a corresponding angle. As shown in fig. 3, the angle may be about 70 degrees.

The starting points of the helical grooves 4, 5 may be angularly offset in the circumferential direction of the core 1 by 360 degrees divided by the number of grooves. It must be understood that the number of slots shown is not limited to the number shown in the embodiment according to fig. 1 to 14. The number of defects 18 and/or grooves 4, 5 may depend on the desired laser emission profile.

Fig. 3 shows that the two helical flutes 4, 5 may have substantially the same helix angle alpha value with respect to the longitudinal axis 16 of the core 1 and may extend in the same direction.

In fig. 5 and 14, it is shown that the helix angle α values of the helical flutes 4, 5 are substantially the same, wherein the helical flutes 4, 5 may extend in opposite directions such that the flutes of respective pairs of helical flutes 4, 5 cross each other. The intersection point is particularly shown in fig. 14 and 5.

As shown in fig. 3, the helix angle alpha of the helical flutes 4, 5 may preferably have a value of about 60 degrees relative to the longitudinal axis 16 of the core 1.

Fig. 15 shows a process variant of a method for producing the device 17 and/or the diffuser 13, wherein the symbols S1 to S6 refer to individual process steps which can be carried out continuously. The method is not limited to steps S1 to S6.

A presently preferred, but non-limiting, method for manufacturing the above-described device may include the steps of:

step S1: a length of the protective sheath 25 from the distal end of the waveguide 12 that is longer than the length of the section of the core 1 and its cladding 2 to be provided with the defect 18 (in particular the slot 4, 5) is removed, and a short length of the outer layer 14 of the protective sheath 25 is removed, which substantially corresponds to the length of the increased diameter portion at the proximal end of the cover 7.

Step S2: a reflector 6 is provided at the distal end of the bare core 1 and its cladding 2. The reflector 6 may be provided by removing material of the core 1 and/or the cladding 2, in particular in the following manner: so that the reflector 6 has the geometrical form of a reflection cone, wherein the cone angle of the reflection cone may vary between 60 and 90 degrees.

Step S3: the defective portion 18 (in particular the grooves 4, 5) is formed by: by means of CO2The laser beam 20 or plasma beam cuts the defect 18, in particular the groove 4, 5, through the optical cladding 2, in particular into the core 1, and rotates the core 1 and its optical cladding 2 about its longitudinal axis 16 relative to the laser beam 20, and moves the laser beam 20 and/or the waveguide 12 and the core 1 and its optical cladding 2 axially along the longitudinal axis 16 of the core 1 in a manner synchronized with the rotation of the core 1.

Step S4: the cover 7 is slid over the core 1 and a section of the optical cladding 2 and optionally over a short length of the outer layer 14 of the buffer layer 3 from which the protective sheath 25 has been removed.

Step S5: the cover 7 is fused to the optical cladding 2 such that a fused region 32 is present between the outer surface 19 of the cladding 2 and the inner surface 21 of the cover 7.

The outer surface 19 of the optical cladding 2 may be at least partially fused to the inner surface 21 of the cover 7 in the region a between the defects 18. Alternatively or additionally, the outer surface 19 of the optical cladding 2, which extends a distance in front of and/or behind the region a where the defect 18 is provided (in particular region B and/or region C), is at least partially fused to the inner surface 21 of the cover 7. In the regions B and/or C, the fused region(s) 32 may be designed as at least partial regions/partial zones, or at least as sub-portions/sub-sections (partial fusion), which may be provided in the circumferential direction.

Fusing may be achieved by: a vacuum is applied to the still open end of the cover 7 and the device 17 and/or the diffuser 13 are heated at the active area a and/or in the area to be fused, in particular the area a, the area B and/or the area C (hereinafter fusion area 32), so that the cover 7 partially collapses and is fused to the optical cladding 2. Thus, a fused region(s) 32 may be achieved, wherein the lid 7 is preferably fused to the cladding 2 and the core 1 between the defect 18, in particular the slot 4, 5, and short lengths at the front and end of the active region "a" (region a).

Step S6 may be performed after fusing the cover 7 to the core 1 and/or to the cladding 2 (see step S5). In step S6, the following further steps a) to d) may preferably be performed successively (one after the other):

step S6: a) the device 17 comprising the cap 7 (in which the distal end of the waveguide 12 is housed) and/or the diffuser 13 are inserted through an annular seal at the top of a vacuum-tight container having a bottle filled with adhesive at its bottom and applying at least a partial vacuum inside the container.

b) The device 17 and/or the diffuser 13 are introduced until after the distal end of the cap 7 enters the bottle filled with adhesive.

c) The vacuum is released from the container so that adhesive 9 from the bottle is drawn into one or more, preferably any, of the gaps between the cap 7, the cushioning layer 3 and/or the outer sheath 14 and the unfused proximal portion of the core 1 and its cladding 2.

The adhesive 9 is shaped to bridge the proximal end of the cover 7 with the outer layer 14 of the protective sheath 25 (outer sheath 14) and to remove any adhesive that remains adhered to the outer surface of the cover 7.

REFERENCE LIST

1 core

2 cladding

3 buffer layer

4 groove

5 groove

6 reflector

7 cover

8 section

9 adhesive

10 source

11 small gap

12 waveguide

13 diffuser

14 outer sheath

15 small clearance

16 longitudinal axis 1

17 device

18 defective part

19 outer surface 2

20 laser beam

21 inner surface 7

22 outside diameter 1

23 outside diameter 2

24 jacket thickness 2

25 protective sheath

26 oval groove

27 longitudinal groove

28 break groove

29 length a

30 depth 18

31 width 18

32 fused area

40 groove

50 groove

Region A

Region B

C region

Alpha helix angle.

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