LIGHT APPLICATOR SYSTEM WITH PROTECTIVE SLEEVE

Description

[0001] The present disclosure relates to a light applicator system for the examination and / or treatment of an organic body, in particular for photodynamic therapy (PDT) of pathological tissue.

[0002] It is well known that endoscopes are used to make video recordings of the inside of a human or animal body for the purposes of medical diagnosis and / or therapy. There is a constant effort to make the insertion section of endoscopes as thin as possible so that the smallest possible cavities can be viewed and tissue damage is minimized.

[0003] Endoscopes are not only used to take images or videos, but also as diagnostic and therapeutic tools. For example, fluorescence endoscopy can be used to detect and localize pre- and early-malignant tissue. This technique does not rely on a true-color representation of the tissue, but rather on fluorescence excitation, which allows pathological tissue to be distinguished from healthy tissue. The pathological tissue itself, or a bacterial colony indicative of pathological tissue, can fluoresce specifically when stimulated by light radiation, thus allowing it to be clearly located in relation to the surrounding healthy tissue. Fluorescence endoscopy can be used, for example, in photodynamic diagnosis (PDD) and / or photodynamic therapy (PDT) with the aid of a photosensitizer.The procedure involves the use of a marker substance that selectively accumulates in pathological tissue.

[0004] In photodynamic therapy (PDT), light is applied directly to or even into pathological tissue using a light applicator. The aim is to induce the formation of oxygen radicals through the locally concentrated photosensitizer or marker substance, thereby destroying the pathological tissue, such as a tumor. Typically, laser light is coupled into an optical fiber and directed to the tissue. If the pathological tissue is located across an area on an external surface, such as the skin, or an internal surface, such as the lining of the esophagus or intestinal wall, the therapeutic light can be relatively easily extracted and directed onto the pathological tissue. However, if the pathological tissue extends over a volume, the limited penetration depth of the light into the tissue means that a tumor cannot always be effectively irradiated from the outside.In this case, PDT is particularly effective when the light is emitted as isotropically as possible from within the pathological tissue volume. For this to occur, the light applicator must be inserted into the pathological tissue. This is also referred to as interstitial (through internal surfaces) and / or percutaneous (through the skin) PDT.

[0005] US patent 6,048,359, for example, describes how multiple light applicators are inserted into pathological tissue using a positioning grid. German patent DE 10 2019 129 556 A1 describes a light applicator with a rigid insertion sleeve to stabilize a flexible conductor element for insertion. German patent DE 10 2019 212 197 A1 describes a light applicator system with at least one light applicator that is identifiable when connected to an operating unit.

[0006] A disadvantage of the known solutions is that the very sharp applicator tip is, firstly, dangerously sharp for a user and, secondly, can easily break off during handling before the actual insertion into the patient's skin.

[0007] This results in the task of providing a light applicator in which the sharp and sensitive applicator tip is protected until the actual insertion in such a way that it does not endanger the user and does not break off before the actual insertion into the patient's skin.

[0008] According to the present disclosure, a light applicator system for the examination and / or treatment of an organic body is provided to solve this problem, wherein the light applicator system comprises at least one light applicator and a positioning element, wherein the light applicator has a distal insertion section with at least one active light-emitting element, e.g., an LED, at the distal end for piercing tissue of the organic body, wherein the insertion section has a needle tip that is arranged at least partially distal to the at least one active light-emitting element and tapers distally, wherein the needle tip can be designed as a light-transparent diffusing body for scattering light emitted in a distal direction.wherein the positioning element can be fixed at least temporarily in a defined position and orientation relative to the organic body and has at least one receptacle for the at least one light applicator in which the at least one light applicator has at least temporarily a defined orientation relative to the organic body, wherein the light applicator has a protective sleeve axially movable relative to the insertion section, which in a first axial position relative to the insertion section protectively encloses the needle tip and in a second axial position determined by an axial position of the insertion section (1) relative to the positioning element is pushed back proximally from the needle tip relative to the insertion section, wherein the protective sleeve serves as an insertion sleeve for secure insertion into the at least one receptacle of the positioning element.

[0009] The light applicator disclosed herein does not use a laser light guide. Instead, the diagnostic or therapeutic light is generated in situ at the distal end of the applicator by an actively emitting element, such as a miniaturized LED with a lateral width of less than 1 mm. "Active" means that the light-emitting element absorbs electrical energy and converts it into light, rather than simply transmitting it via a light guide. Therefore, an expensive laser is not required, significantly reducing costs. The light applicator disclosed herein, or at least its insertion section, can be manufactured very cost-effectively and thus realized as a sterile, single-use device, eliminating the need for complex cleaning and sterilization procedures by the user.For larger tumors or entire pathological organs or organ regions, the light applicator system can have multiple light applicators that are used simultaneously for PDT. These applicators are inserted at intervals throughout the organ to ensure homogeneous illumination. Because the photosensitizer or marker substance selectively accumulates only in pathological tissue and reacts there under the influence of light, healthy tissue is not damaged. This eliminates the need for precise localization of the pathological tissue beforehand and reduces the risk of pathological tissue going undetected and untreated.

[0010] For percutaneous PDT with multiple light applicators, it can be useful for the positioning element to have a large number of images and to form an organ-specific template that can be defined and / or adhered to the patient's skin, in order to show the user insertion points, angles and / or depths for the light applicators and to achieve the most complete and largely homogeneous illumination of the organ possible.

[0011] The light applicator can be used not only for therapy but also for examination, i.e., diagnosis. In particular, when used in conjunction with an endoscope or as part of an endoscope, the fluorescence generated by the light applicator of a photosensitizer or marker substance concentrated in pathological tissue can be observed.

[0012] Optionally, the protective sleeve can have, at least in sections, an outer diameter that fits precisely into an inner diameter of the at least one receptacle of the positioning element. This ensures that the protective sleeve is only aligned coaxially within the at least one receptacle of the positioning element and prevents any pivoting. Once the protective sleeve is in the at least one receptacle of the positioning element, only axial movement of the light applicator is possible. The protective sleeve is preferably pushed distally into the at least one receptacle of the positioning element until it reaches a target axial position, which is preferably its maximum distal position.For example, when the protective sleeve is inserted distally into the at least one receptacle of the positioning element, it may strike a stop against the positioning element upon reaching the desired position.

[0013] Optionally, the outer diameter of the protective sleeve can taper distally at the distal end and / or the inner diameter of at least one receptacle of the positioning element can widen proximally at the proximal end. This facilitates the insertion of the protective sleeve into the receptacle of the positioning element.

[0014] Optionally, the insertion section of the light applicator can be rigid and have a greater axial length than the protective sleeve. The insertion section preferably corresponds to a very thin, rigid needle, at the light-diffusing tip of which the light from a miniaturized LED arranged in or on the tip is positioned.

[0015] Optionally, the protective sleeve can be permanently secured to the insertion section of the light applicator. This protects the needle tip even outside of actual use, for example during transport and / or disposal of the light applicator.

[0016] Optionally, the light applicator can have a handle on its proximal side for manual positioning. As long as the orientation is not yet fixed by the inserted protective sleeve within the positioning element, the handle can also be used to align the light applicator outside of the positioning element. The handle can be permanently attached to the insertion section or detachably connected to it. The handle can be reusable, and the detachable insertion section can be a disposable item for single use.

[0017] Optionally, when the light applicator is inserted distally into the at least one receptacle of the positioning element, the protective sleeve can be secured in the first axial position until it reaches a predetermined position within the positioning element, at which point the insertion section can be pushed distally out of the protective sleeve. Preferably, the predetermined position is the maximum distal position of the protective sleeve within the receptacle of the positioning element. In this predetermined position, the protective sleeve is preferably located completely or at least largely within the receptacle of the positioning element and is locked into place.

[0018] Optionally, when the light applicator is pulled out proximally from the at least one receptacle of the positioning element, the protective sleeve can be secured in the intended position in the positioning element until the protective sleeve assumes the first axial position with respect to the insertion section, at which point the protective sleeve can be pulled out proximally from the at least one receptacle of the positioning element.

[0019] Optionally, the light applicator system can further comprise an elastically deformable and / or movable engagement element, wherein the engagement element is arranged between the insertion section and the protective sleeve such that, upon overcoming an axial force, it elastically yields or moves sufficiently to allow the protective sleeve to reach the first axial position distally and / or to move out of it proximally. Optionally, the first engagement element can be part of the protective sleeve and / or the insertion section.

[0020] Optionally, the light applicator system can have a further elastically deformable and / or movable engagement element, wherein the second engagement element is arranged between the protective sleeve and the at least one receptacle of the positioning element such that, upon overcoming the second axial force, it elastically yields or moves sufficiently to allow the protective sleeve to reach the target position distally and / or leave it proximally within the positioning element. Optionally, the second engagement element can be part of the protective sleeve or the positioning element.

[0021] Optionally, distally the first axial force can be greater than the second axial force, and proximally the second axial force can be greater than the first axial force.

[0022] The terms "distal" and "proximal" are used here to refer to a relative position distal or proximal to a user of the system as a reference point. Similarly, the terms "distal" and "proximal" refer to positions on the distal or proximal side of an object. Finally, the terms "distal" and "proximal" refer to directions extending distally or proximally.

[0023] The disclosure is explained in more detail below with reference to exemplary embodiments shown in the drawings. These show: Fig. 1a,b two schematic longitudinal sectional views of embodiments of a needle tip of an insertion section of a light applicator system disclosed herein; Fig. 2 a schematic longitudinal section of the in Fig. 1aThe illustrated embodiment of a needle tip of an insertion section under lateral force; Fig. 3a,b two schematic longitudinal section diagrams to illustrate the generation of a lateral force when using a light applicator system disclosed herein; Fig. 4 a schematic longitudinal section view of an embodiment of a light applicator system disclosed herein before the light applicator is inserted into the positioning element; Fig. 5 a schematic longitudinal section view of an embodiment of a light applicator system disclosed herein during tilting while the light applicator is being inserted into the positioning element; Fig. 6a schematic longitudinal section view of an embodiment of a light applicator system disclosed herein when the light applicator is inserted into the positioning element with the protective sleeve in the first axial position with respect to the insertion section; Fig. 7 a schematic longitudinal section view of an embodiment of a light applicator system disclosed herein during the insertion of the insertion section into the body; Fig. 8 a schematic longitudinal section representation of an embodiment of a light applicator system disclosed herein during the insertion section passing through the body and during insertion into the tissue to be examined / treated; Fig. 9 a schematic longitudinal section representation of an embodiment of the light applicator of a light applicator system disclosed herein; Fig. 10a schematic longitudinal sectional representation of an embodiment of the protective sleeve in the positioning element of a light applicator system disclosed herein, wherein the light applicator is not shown; Fig. 11 a schematic longitudinal section view of an embodiment of a light applicator system disclosed herein during the insertion of the insertion section into the body, wherein the protective sleeve is not in the first axial position with respect to the insertion section; Fig. 12 a schematic longitudinal section view of an embodiment of the light applicator during insertion into the positioning element with the protective sleeve in the first axial position with respect to the insertion section and before the protective sleeve has reached an axial target position in the positioning element; Fig. 13a schematic longitudinal section view of an embodiment of the light applicator during insertion into the positioning element with the protective sleeve in the first axial position with respect to the insertion section, wherein the protective sleeve has just reached the axial target position in the positioning element; Fig. 14 a schematic longitudinal section view of an embodiment of the light applicator during distal pushing of the needle tip of the insertion section out of the protective sleeve located in the axial target position in the positioning element into the body; Fig. 15 a schematic longitudinal section view of an embodiment of the light applicator during the proximal insertion of the needle tip of the insertion section from the body into the protective sleeve located in the axial target position in the positioning element; Fig. 16a schematic longitudinal section view of an embodiment of the light applicator as it is being pulled out of the positioning element, wherein the protective sleeve has just assumed the first axial position with respect to the insertion section, but is still in the axial target position with respect to the positioning element; Fig. 17 a schematic longitudinal section view of an embodiment of the light applicator as it is pulled out of the positioning element with the protective sleeve in the first axial position with respect to the insertion section and after the protective sleeve has left the axial target position in the positioning element proximally; Fig. 18 a schematic longitudinal section representation of an embodiment of a light applicator system disclosed herein to illustrate the fixation of the positioning element relative to the patient's body; Figs. 19 to 26Schematic longitudinal sectional views with detailed sections of an exemplary embodiment of a light applicator system disclosed herein, analogous to Figs. 11 to 17 in different positions of the light applicator; and Fig. 27 a schematic longitudinal section representation of an alternative embodiment of a light applicator system disclosed herein.

[0024] Fig. 1a, 1b , 2 , 3a and 3b illustrate the problem solved by the light applicator system disclosed herein. Fig. 1a and 1b Figure 1 shows various embodiments of a distal end of an insertion section 1 of a light applicator of a light applicator system disclosed herein. The distal end serves for insertion into tissue 3 of an organic body 5 (see Figure 1). Figs. 3a and 3b), to irradiate tissue 3 with light for photodynamic therapy (PDT) or diagnosis (PDD). The insertion section 1 of the light applicator is designed to be needle-shaped, as thin as possible (with a diameter of, for example, less than 2 mm), and rigid for the most minimally invasive treatment or diagnosis possible.

[0025] The distal end of the insertion section 1 features, as an example, an actively light-emitting element 7 in the form of an LED, whose main emission direction is directed in the longitudinal direction ZN of the insertion section 1. At least partially distal to the LED 7, a needle tip 9, tapering distally to a point, is arranged, which incorporates a light-transparent diffuser for scattering the light from the LED 7. The needle tip 9 is essentially formed in one piece from the light-transparent diffuser, which may, for example, be made of plastic with one or more reinforcing elements.

[0026] The LED 7 is arranged on a distal end face of a conductor element 11. The conductor element 11 is designed as a solid metal rod. The conductor element 11 can serve both as an electrical conductor for supplying power to the LED 7 and as a thermal conductor for dissipating heat generated by the LED 7 proximally. For this purpose, the core of the conductor element 11 can, for example, be made of copper, which is a good thermal and electrical conductor. To stiffen the conductor element 11, which can have a diameter of 1 mm or less, a sheath of the conductor element 11 can be made of a more rigid material, such as steel. If the core and sheath of the conductor element 11 are electrically insulated from each other, for example by a thin insulating layer between them, the core and sheath can function as the forward and return conductor pairs for supplying power to the LED 7.

[0027] As in Figures 1a and 1bAs shown, the cross-sectional area of ​​the conductor element 11 is only slightly larger than the cross-sectional area of ​​the LED 7. To avoid attaching the needle tip 9 exclusively to an end face 7a of the LED 7 and to prevent the needle tip 9 from extending beyond the cross-sectional area of ​​the conductor element 11, the needle tip 9 has a proximally shaped, sleeve-like section 9a that circumferentially surrounds the LED 7 and connects the needle tip 9 directly to the end face of the conductor element 11. The needle tip 9 is connected to the LED 7 and the conductor element 11 via a planar connection 13, preferably by a material bond along the connection 13. To enlarge the planar connection 13 directly between the needle tip 9 and the conductor element 11, the following is shown in the figure. Fig. 1bIn the illustrated embodiment, the proximal-side sleeve-shaped section 9a is axially longer, and the conductor element 11 has a correspondingly tapered distal section that is circumferentially encompassed by the sleeve-shaped section 9a of the needle tip 9. This allows the needle tip 9 to be bonded not only directly to the conductor element 11 at its end face, but also circumferentially to the tapered distal section of the conductor element 11. This makes the connection point 13 larger and stronger.

[0028] Fig. 2This shows that the needle tip 9 can easily tear off or break. Since the needle tip 9 must be as sharp as possible for minimally invasive treatment or therapy, it is preferably significantly longer in the longitudinal direction ZN than its diameter. If a lateral force FL,S 15 is now exerted on the distal end of the needle tip 9 by an external body 17, an increased detachment force 19 acts at the connection point 13 due to leverage, which can then tear as shown. This danger also exists for the embodiment according to Fig. 1b , although the connection point 13 is in principle stronger there. However, in both embodiments according to Fig. 1a and 1b the risk that the proximal-side sleeve-shaped section 9a may break off from the rest of the needle tip 9, since the sleeve-shaped section 9a can only be made very thin.

[0029] The Fig. 1a, 1b and 2Figure 1 shows an exemplary embodiment in which the active light-emitting element is a single LED 7 arranged on the distal end face of the conductor element 11. Alternatively, several active light-emitting elements can be used instead of the single LED 7, and these can also be other active light-emitting elements, e.g., laser diodes. As an alternative to placement on the distal end face of the conductor element 11, the at least one active light-emitting element can also be placed on the lateral surface of the distal insertion section 1 or of the conductor element 11 of the light applicator 21. Furthermore, the needle tip 9 does not necessarily have to be a separate part that is bonded to the distal end of the insertion section 1. Instead, the needle tip 9 can also be an extension of the conductor element 11.The essential task then becomes protecting the user and the patient from unintentional contact with the sharp needle tip 9 and any resulting injury. The following descriptions consider, as an example, the LED 7 arranged on the distal end face of the conductor element 11, with the distally attached, for example, glued needle tip 9, which is designed as a diffuser.

[0030] Figs. 3a and 3b This document shows how, when using a light applicator system 21 disclosed herein, a lateral force FL,S 15 can act on the needle tip 9. The light applicator system comprises a light applicator 21, which includes the insertion section 1, a handle element 23, and a power supply unit (not shown) that can be connected via a connecting cable 25.

[0031] An operator grasps the handle element 23 with their hand 27 to insert the insertion section 1 through the skin 5a into the patient's body 5 in the direction of the tissue 3 to be examined or treated. Figs. 3a and 3b The size relationships are schematically indicated, which cannot be shown to scale here. The insertion section 1 has a relatively large length d1 + d2 from the distal end of the needle tip 9 to the handle element 23, e.g., 20 cm or more, and is very thin, e.g., with a diameter of 1 mm or less. The length of the needle tip 9 is denoted here by d2, and the remainder of the length of the insertion section 1 by d1. d 1 » d2. Due to these size relationships, the lever principle results in a relatively large lateral force FL,S 15 acting on the needle tip 9, even when the operator exerts only a relatively small lateral force FL,H 29 on the handle element 23. In the case shown, the needle was initially inserted vertically in the Z-direction into the skin 5a, but then the light applicator 21 was slightly angled by a relatively small lateral manual force FL,H 29 on the handle element 23, which is unavoidable with manual handling. A much larger lateral force FL,S 15 then acts on the needle tip 9, which can lead to the needle tip 9 tearing off or breaking off, since F L , S ≈ d 1 d 2 ⋅ F L , H applies.

[0032] Fig. 4Figure 31 shows a light applicator system 31 in which the risk of the needle tip 9 breaking off or being torn off is significantly reduced. The light applicator system 31 comprises a light applicator 21 with an insertion section 1, a needle tip 9 at the distal end, and a handle element 23 at the proximal end. Furthermore, the light applicator system 31 has a positioning element 33 that can be fixed, at least temporarily, in a defined position and orientation relative to the organic body 5. The positioning element 33 can be, as shown in Figure 31, Fig. 4The positioning element 33 can be shown schematically as being at a distance from the skin 5a or arranged in direct contact with the skin 5a, for example, adhered to the skin 5a. The positioning element 33 can be a template with at least one receptacle 35 for the light applicator 21. The receptacle 35 can be a recess or a hole in the positioning element 33 that defines the insertion point on the skin 5a in a plane orthogonal to the perpendicular insertion direction Z. Preferably, several receptacles 35 are arranged in this plane orthogonal to the perpendicular insertion direction Z in order to give the operator a selection from a predefined set of defined insertion points and / or to use several light applicators 21 simultaneously.The positioning element 33 and the patient's body 5 are preferably fixed or fixable relative to each other by means of a fixing element 37, preferably both with respect to a fixed local reference body, for example a treatment table.

[0033] In the axial insertion direction Z, the positioning element 33 has a certain thickness L, such that the receptacle 35 has a length L in the axial direction Z. This length L defines not only the position of the insertion point but also the orientation of the light applicator 21 relative to the body 5. In the Fig. 4 In the case shown, only one perpendicular insertion into the skin 5a is permitted by the device 35. The positioning element 33 is preferably designed to be rigid and inflexible.

[0034] Since the risk of the needle tip breaking off or snapping off when tilted (see Fig. 4) during the manual insertion of the insertion section 1 into the rigid and inflexible positioning element 33 is even greater than in the case of the Figs. 3a and 3b In the tilted insertion shown directly into the skin 5a without a positioning element 33, the light applicator system 31 has a protective sleeve 39. The protective sleeve 39 is axially movable relative to the insertion section 1, but is temporarily fixed in at least one first axial position relative to the insertion section 1. In the Fig. 4In the first axial position shown, relative to the insertion section 1, the protective sleeve 39 surrounds the needle tip 9. In this first axial position, the protective sleeve 39 projects axially beyond the distal end of the needle tip 9. This protects not only the needle tip 9, but also a patient and / or operator from accidental puncture by the very sharp needle tip 9. The protective sleeve 39 is securely attached to the insertion section 1 of the light applicator 21 in such a way that it cannot fall off or be pulled off distally from the insertion section 1. Fig. 4 The first axial position shown is the maximum distal axial position relative to the insertion section 1 of the light applicator 21. In the proximal direction, the handle element 23 or another stop (not shown here) can limit the maximum axial freedom of movement of the protective sleeve 39 along the insertion section 1.

[0035] The inner diameter of the receptacle 35 is precisely matched to the outer diameter of the protective sleeve 39, allowing it to be inserted precisely into the receptacle 35 of the positioning element 33 in the axial direction Z. To facilitate insertion into the receptacle 35, the outer diameter of the protective sleeve 39 tapers distally at its distal end.

[0036] Fig. 5 Figure 1 shows how the protective sleeve 39 protects the needle tip 9 from the impact of the large lateral force FL,S 15, which is already caused by a relatively small manual tilting force FL,H 29 on the handle element 23. The axial length of the protective sleeve 39 exceeds the axial length of the needle tip 9 by at least twice, and in this case by several times. The axial length of the protective sleeve 39 corresponds to at least half the length L of the receptacle 35; here they are essentially equal.

[0037] In Fig. 6The insertion section 1, together with the protective sleeve 39, is inserted into the receptacle 35 of the positioning element 33, so that the light applicator 21 is aligned exactly perpendicular to the skin 5a in the Z-direction. The protective sleeve 39 is still in its first axial position relative to the insertion section 1, in which it protectively encloses the needle tip 9. To further advance the insertion section 1, the operator only needs to manually apply an axial force FA to the handle element 23. Any manual tilting forces FL,H 29 on the handle element 23 would only cause the insertion section 1 to bend, but would not exert more than a lateral force FL,S 15 on the needle tip 9 protected by the protective sleeve 39.

[0038] In Fig. 7 The needle tip 9 of the insertion section 1 has already been inserted into the skin 5a. However, the protective sleeve 39 is in the Fig. 6The protective sleeve 39 remains in the position shown in the receptacle 35 of the positioning element 33. The protective sleeve 39 can, for example, act as a stop (in Fig. 7 (not shown) exhibiting a maximally distal position of the protective sleeve 39 in the receptacle 35 of the positioning element 33, by the stop abutting the positioning element 33. By pushing the insertion section 1 distally out of the protective sleeve 39, the protective sleeve 39 has left its first axial position relative to the insertion section 1 and is now in a second axial position, in which the protective sleeve 39 is axially retracted relative to the needle tip 9. There can be many second axial positions, the second axial position depending on the insertion depth of the needle tip 9 into the body 5, the maximum of which is limited only by the length of the insertion section 1, i.e., would be reached if the handle element 23 abutted the positioning element 33.

[0039] In Fig. 8The needle tip 9 is inserted into the tissue 3 and has reached the axial target position in which PDD or PDT can be performed. This means the LED 7 is switched on, and the needle tip 9, with its light-transparent diffuser, scatters the light 43 from the LED 7 into the tissue 3 over the largest possible solid angle, preferably significantly greater than 3π. The tissue 3 can be, for example, a tumor or other pathological tissue that reacts to the light 43 from the LED 7, with or without the aid of a photosensitizer concentrated therein, generating locally localized toxic substances, such as oxygen radicals, which damage the pathological tissue 3. Since this process requires a certain duration of light exposure, the insertion section 1 is preferably fixed relative to the positioning element 33 in this selected second axial position. For this purpose, a clamping element (not shown here) can, for example, clamp the protective sleeve 39 to the insertion section 1.Additionally, the clamping element can also clamp the protective sleeve 39 to the positioning element 33.

[0040] Fig. 9 Figure 1 shows a schematically enlarged version of the light applicator 21. At full scale, it would not have fit lengthwise on the paper and is therefore shown shortened. The protective sleeve 39 has an inner diameter that fits precisely onto the outer diameter of the insertion section 1. The protective sleeve 39 encloses the needle tip 9 protectively in the first axial position shown, relative to the insertion cut 1. The handle element 23 is located at the proximal end of the light applicator 21. At the distal end of the protective sleeve 39, the outer surface is chamfered, i.e., the outer diameter tapers distally, allowing the protective sleeve to be more easily inserted into the receptacle 35 of the positioning element 33.

[0041] In Fig. 10The protective sleeve 39 is shown in the receptacle 35 of the positioning element 33, in which it fits precisely. Here, the length of the protective sleeve 39 is essentially equal to the thickness L of the positioning element, which corresponds to the axial length L of the receptacle 35, thus ensuring good guidance.

[0042] Fig. 11This illustrates a problem if the protective sleeve 39 is not correctly seated in the receptacle 35 of the positioning element 33 and has simultaneously left its initial axial position. This can occur, for example, during insertion if the distal end of the protective sleeve 39 abuts the positioning element 33 and the needle tip 9 is forced distally out of the protective sleeve 39. Similarly, this situation can arise during the proximal retraction of the light applicator 21 if the protective sleeve 39 is prematurely pulled proximally out of the receptacle 35 of the positioning element 33 before the needle tip 9 has been drawn far enough into the protective sleeve 39 to assume its protective initial axial position.Since the inner diameter of the receptacle 35 is adapted to the outer diameter of the protective sleeve 39, which is larger than the outer diameter of the insertion element 1, the insertion element 1 has considerable lateral play in the receptacle 35 without the correctly positioned protective sleeve 39. As shown in . Fig. 11 As shown, the light applicator 21 can then become tilted, so that the longitudinal axis ZN no longer aligns with the intended insertion direction Z. As a result, considerable lateral forces FL,S 15 can act on the needle tip 9, as described above, which can lead to the needle tip 9 tearing off or breaking off.

[0043] In the Figures 12 to 17 The axial force relationships that preferably prevail in the light applicator system 31 disclosed herein are illustrated. In the Fig. 12Following the insertion of the protective sleeve 39 into the receptacle 35 as shown, the protective sleeve 39 remains in the first axial position. To achieve this, the protective sleeve 39 has a first mechanical interface 45 on the inside for the insertion section 1 and a second mechanical interface 47 on the outside for the positioning element 33. The interfaces 45 and 47 can be, for example, friction surfaces or friction points. The interfaces 45 and 47 each generate a resistance force opposite to the axial insertion force FA, for example, a static and / or sliding friction force. As long as the protective sleeve 39 has not yet reached its final maximal distal position in the receptacle 35, the resistance force generated by the second interface 47 is F L → E smaller than the penetration force FA. The resistance force generated by the first interface 45 F A → EHowever, it is greater than the resistance force generated by the second interface 47. F L → E . Therefore, the protective sleeve 39 remains in the first axial position with respect to the insertion section 1 and transmits the insertion force FA by means of the resistance force. F A → E onto the protective sleeve 39. Therefore, the protective sleeve 39 moves distally into the receptacle 35 against the smaller resistance force. FL→E .

[0044] In Fig. 13The figure shows the moment when the protective sleeve 39 has reached its final distal position, i.e., its intended position, in the receptacle 35, and is simultaneously still in its first axial position with respect to the insertion section 1. The protective sleeve 39 may, for example, have just come into contact with the positioning element 33 with a stop (not shown). The stop could be considered part of the second interface 47, with the proximal resistance force being... F L → E Upon impact, it is immediately increased to such an extent that it is greater than the proximal-side resistance force. F A → E The protective sleeve 39 cannot be pushed further distally because the positioning element 33 is fixed relative to the body 5. The operator must apply the insertion force FA to the Figure 12 increase to achieve greater resistance F A → Eto overcome the first interface 45 in order to push the needle tip 9 distally out of the protective sleeve 39.

[0045] In Fig. 14 The protective sleeve 39 has left the first axial position by the insertion section 1 being pushed distally out of the protective sleeve 39, which is in its maximum distal position, i.e., the intended position. As soon as a high resistance force is initially present in the first axial position... F A → E Once the first interface 45 is overcome, the resistance can be increased. F A → E Outside the first axial position, the effect will be less pronounced, so that during further pre-punching, as in Fig. 14 It has been shown that the penetration force FA can be lower again. For example, the initially high resistance force F A → E include a static friction force and / or an elastic deformation force. The resistance force F A → EThis force can decrease when the static friction force transitions into a lower sliding friction force and / or no elastic deformation force is required. During and after the insertion into the skin 5a and the body 5, additional resistance forces counteract the insertion force FA, which must be sufficiently large to allow the needle tip 9 to penetrate to the tissue 3. However, to make the insertion as minimally invasive as possible, the insertion section 1 is designed to be as thin as possible within the limits of stability, and the needle tip 9 is designed to be as sharp as possible, so that the resistance forces induced by the skin 5a and / or the body 5 are minimized.

[0046] In Fig. 15After PDD or PDT, the insertion section 1 is withdrawn proximally from the body 5. The protective sleeve 39 is locked in the maximum distal position, so that the distal resistance force generated by the second interface 47 F L → E is higher than the distal resistance force generated by the first interface 45 F A → E . This ensures that the protective sleeve 39 remains in the maximum distal position, i.e., the intended position, in the receptacle 35 of the positioning element 33, while the needle tip 9 is retracted proximally into the protective sleeve 39.

[0047] In Fig. 16The needle tip 9 is maximally retracted proximally into the protective sleeve 39, so that the protective sleeve 39 again assumes its protective first axial position with respect to the insertion section 1. The first interface 45 can have a stop that, at the maximal proximal position of the insertion section 1 with respect to the protective sleeve 39, abuts proximally, so that the distal resistance force F A → E greater than the distal resistance force generated by the engaged second interface 47 F L → E The operator must increase the proximal pull-out force FA to reduce the distal resistance. F L → E to overcome and release the second interface 47 from its engagement. The protective sleeve 39 then leaves its intended position in the receptacle 35 proximally and remains in the first axial position with respect to the insertion section 1.

[0048] As soon as the second interface 47 engages, as in Fig. 17 As shown, and solved, the pull-out force FA is subject to a lower sliding friction force. F L → E The second interface 47 is thus opened, allowing the protective sleeve 39, which is in the protective first axial position with respect to the insertion section 1, to be easily pulled proximally out of the receptacle 35. The needle tip 9 remains protected by the protective sleeve 39 in the first axial position. Likewise, the protective sleeve 39 protects the operator and / or patient from unintentional puncture with the needle tip 9.

[0049] Fig. 18Figure 37 shows the fixation of the positioning element 33 relative to the patient's body 5 in more detail. The fixing element 37 has an articulated arm with several joints 49, whereby the positioning element 33 can be fixed in preferably six degrees of freedom, i.e., arbitrarily positioned in three spatial directions x, y, z and arbitrarily oriented in three angular settings. A treatment table 51 serves as a local reference body with respect to which the positioning element 33 can be positioned and oriented. The patient's body 5 is preferably also fixed to the treatment table 51 and / or assumes a fixed position on or against it. The positioning element 33 can rest with a distal side on the skin 5a of the body 5. Preferably, the positioning element 33 is even glued to the skin 5a.

[0050] The positioning element 33 can be a perforated plastic plate in the form of a perforated plate or a grid of holes. To ensure precise alignment of the protective sleeve 39, it is advantageous for the receptacle 35 to extend over a certain length L in the Z-direction. For this purpose, the positioning element 33 can have a corresponding thickness L. Alternatively, each receptacle 35 can have a sleeve extension extending in the proximal Z-direction, which is fixedly or detachably connected to the positioning element 33, thus avoiding an unnecessarily bulky and heavy design of the positioning element 33. However, a bulky and heavy design of the positioning element 33 may also be advantageous for certain applications.

[0051] In Figures 19 to 26The functionality of interfaces 45, 47 is explained in more detail using an exemplary embodiment. In the illustrated embodiment, interfaces 45, 47 each have one or more elastically deformable engagement elements 53, 55, here in the form of O-rings. A first engagement element 53 of the first interface 45 is located between the insertion section 1 and the protective sleeve 39 with a radially outer part in a first groove 57 arranged on the inside of the protective sleeve 39 and circumferentially extending around it. A radially inner part of the first engagement element 53, which is smaller here than the radially outer part, lies in the groove 57. Fig. 19The first axial position of the protective sleeve 39 shown is in a radially circumferential first counter-groove 59 arranged on the outside of the insertion section 1. A second engagement element 55 of the second interface 47 is located between the protective sleeve 39 and the positioning element 33 with a radially inner part in a radially circumferential second groove 61 arranged on the outside of the protective sleeve 39. A radially outer part of the second engagement element 55, which is smaller here than the radially inner part, lies in the groove 61 shown in the figure shown. Figs. 21 to 25 The maximum distal position, i.e., the intended position, of the protective sleeve 39 with respect to the receptacle 35 is shown in a second counter groove 63 arranged on the inside of the receptacle 35 of the positioning element 33 and extending radially around it. As soon as the engagement elements 53, 55 are located in the respective counter grooves 59, 63, the corresponding interfaces 45, 47 are "engaged", i.e., the corresponding resistance force is applied. F L →E or F A → E is temporarily increased.

[0052] When inserting the protective sleeve 39 into the receptacle 35, as shown in Fig. 19 As shown, the first engagement element 53 is engaged in the counter groove 59 and the second engagement element 55 is outside the second counter groove 63. Therefore, the proximal resistance force F A → E the first interface 45 higher than the proximal resistance F L → EThe second interface 47 results solely from the sliding friction force between the protective sleeve 39 and the receptacle 35. Therefore, only the portion of the insertion force FA corresponding to the sliding friction force between the protective sleeve 39 and the receptacle 35 acts distally on the engaged first engagement element 53. This force component, however, is insufficient to compress the first engagement element 53 radially outward to such an extent that the counter-groove 59 disengages distally. Accordingly, the proximal radial penetration depth t1 of the first engagement element 53 into the first counter-groove 59 is selected such that a certain minimum distal force must be exerted on the first engagement element 53 by the insertion section 1 to compress it radially outward to such an extent that the counter-groove 59 disengages distally. Below this minimum force, the insertion section 1 is secured distally in the protective sleeve 39, which is in its first axial position.Distally, the protective sleeve 39 is captive and secured to the insertion section 1 by means of a projection, a protrusion, or a thickening that engages behind an inner stop 65 of the protective sleeve 39. Alternatively or additionally, the counter groove 59 is designed asymmetrically such that it can only disengage distally, but not proximally, from the first engagement element 53.

[0053] The resilience F A → EThe resistance of the first interface 45 depends not only on the proximal radial penetration depth t1 of the first engagement element 53 into the first counter groove 59, but also on the geometry of the first engagement element 53 and the geometry of the first counter groove 59. Here, the engagement elements 53, 55 are designed as O-rings, and the cross-sectional geometry of the counter grooves 59, 63 is arc-shaped with a corresponding diameter for the precise fit of the respective O-ring 53, 55. The resistance force F A → E The first interface 45 also depends on one in Fig. 19 ramp angle shown ε from, which can lie between 0° and 90°, where the resistance force F A → E The ramp angle is the maximum for 90° and the minimum for 0°. εis accordingly chosen such that a certain distal minimum force must be exerted on the first engagement element 53 from the insertion section 1 in order to compress it radially outwards to such an extent that the counter groove 59 releases distally.

[0054] In Fig. 20 The protective sleeve 39 is inserted distally into the receptacle 35 to such an extent that the second engagement element 55 just abuts the positioning element 33. The first interface 45 with the first engagement element 53 is opposite Fig. 19unchanged. The proximal end of the receptacle 35 widens proximally, thus forming a conical ramp surface 67. In conjunction with the tapered outer diameter of the protective sleeve 39 at its distal end, this not only facilitates the insertion of the protective sleeve 39 into the receptacle 35, but the ramp surface 67 also serves to compress the second engagement element 55 radially inwards. This reduces the proximal resistance force. F L → E the second interface 47 in a defined manner below the proximal resistance force F A → E held at the first interface 45.

[0055] A proximal end 69 of the second counter groove 63, which here is also a distal end of the ramp surface 67, defines a proximal radial penetration depth t2 by which the second engagement element 55 must be compressed radially inwards before it can expand outwards again into the counter groove 63, i.e., engage there. If the O-rings 53 and 55 have the same cross-section and are made of the same material, the value t2 can correspond to the value t1 of the first interface 45. However, to prevent the first interface 45 from disengaging when the second engagement element 55 is compressed, i.e., to prevent the first engagement element 53 from being compressed, a ramp angle is required. α The ramp surface is chosen to be 67 degrees shallower than the ramp angle. ε the first interface 45, i.e. α < ε This ensures that the resistance is sufficient. F A → Ethe first interface 45 as long as the resistance force is greater F L → E the second interface 47 is until the protective sleeve 39 has reached the maximum distal position, i.e. the target position, in the receptacle 35 and the second engagement element 55 has engaged in the second counter groove 63.

[0056] Fig. 21 Figure 1 shows both interfaces 45 and 47 in the engaged state. The protective sleeve 39 is in both the first axial position with respect to the insertion section 1 and the maximum distal position in the receptacle 35, i.e., in the intended position, since the first interface 45 is engaged in the first counter-groove 59 by means of the first engagement element 53, and the second interface 47 is engaged in the second counter-groove 63 by means of the second engagement element 55. The counter-grooves 59 and 63 are each asymmetrically designed such that the respective resistance forces F A → E orF L → E They differ from each other when leaving the locked position in the distal direction and in the proximal direction.

[0057] The second interface 47 can, for example, form a stop by having a distal end 71 of the second counter-groove 63 extend radially inwards to such an extent that a distal radial penetration depth t 3 of the second engagement element 55 into the second counter-groove 63 results, wherein t 3 > t 2. The second engagement element 55 can be designed such that it cannot be compressed by the penetration depth t 3, or that this would only be possible with an excessively high force. Furthermore, the second counter-groove 63 defines a relatively steep distal ramp angle. γ, where γ > ε. Thus, the second engagement element 55 forms a distal stop in the second counter groove 63, which determines the maximum distal position, i.e. the target position, of the protective sleeve 39 in the receptacle 35.

[0058] The first interface 45 is designed in an analogous, inversely asymmetrical manner. The proximal radial penetration depth t1 of the first engagement element 53 into the first counter-groove 59 is determined by a proximal end 73 of the first counter-groove 59. A distal radial penetration depth t4 of the first engagement element 53 into the first counter-groove 59 is determined by a distal end 75 of the first counter-groove 59, wherein t 4 > t 1. The values ​​t1, t2, t3 and t4 can be chosen such that t 4 = t 3 > t 2 = t1 applies. The first engagement element 53 can be designed in such a way that it cannot actually be compressed by the penetration depth t4, or this would only be possible with an inappropriately high force. Furthermore, the first counter-groove 59 defines a relatively steep distal ramp angle. η , where η > ε Thus, the first engagement element 53 forms a proximal stop in the first counter groove 59, which secures the protective sleeve 39 captive to the insertion section 1. The insertion section 1 also forms a ramp surface 68 on its outer side, analogous to the ramp surface 67 of the second interface 47. The ramp surface 68 extends proximally from the first counter groove 59, so that the insertion section 1 forms a ramp angle δ , which is equal to the ramp angle α The ramp angle can be tapered proximally by approximately the amount t1 over a certain distance. δ is chosen to be so flat that the resistance FA → E the resistance force of the first interface 45 when the needle tip 9 is withdrawn into the protective sleeve 39 is smaller than the resistance force F L → E the second interface 47 engages and thus the first interface 45 engages, before the second interface 47 disengages and the protective sleeve 39 leaves the intended position proximally.

[0059] Fig. 22 shows the resulting resistance forces F A → E and F L → E , when in the locked position of Fig. 21 A distal insertion force FA is exerted on the handle element 23. The proximal resistance force F L → E The resistance of the second interface 47 is now higher than the proximal resistance. F A → E the first interface 45 (because t 3 > t 1 and γ > ε). As a result, the first counter-groove 59 presses with a proximal ramp surface at the ramp angle. ε against the engaged first engagement element 53, so that the proximal end 73 of the first counter groove 59 is pushed distally past it under elastic deformation of the first engagement element 53.

[0060] In Fig. 23 The proximal end 73 of the first counter-groove 59 is pushed distally past it under elastic deformation of the first engagement element 53, thus increasing the initially higher resistance force F A → E The first interface 45 has been overcome. The protective sleeve 39 remains in its maximum distal position with respect to the receptacle 35, but has left its first axial position with respect to the insertion section 1 because the insertion section 1 has been pushed further distally. Now, only a relatively small sliding friction force constitutes the resistance force. F A → Ethe first interface 45, so that the insertion section 1 can be inserted relatively easily into the body 5.

[0061] In Fig. 24 The insertion section 1 is pulled out of the body 5 with a proximal withdrawal force FA. As in Fig. 23 is the sliding friction force, which is the resistance force F A → E the first interface 45 forms, less than the resistance force F L → E the second interface 47. The resistance force F L → E The second interface 47 is defined on the one hand by the proximal penetration depth t 2 of the second engagement element 55 into the second counter groove 63 and on the other hand by a proximal ramp angle β the second counter groove 63 is determined. The ramp angle β the second interface 47 can be adjusted to the ramp angle εcorresponding to the first interface 47. This means that the protective sleeve 39 remains in the maximum distal position, i.e., the intended position, in the receptacle 35, with the needle tip 9 being drawn proximally into the protective sleeve 39.

[0062] In Fig. 25 The first interface 45 has engaged again, so that the protective sleeve 39 is in the first axial position with respect to the insertion section 1, in which it protectively surrounds the needle tip 9. Due to the relatively high penetration depth t 4 and the relatively steep ramp angle η , which together effectively form a proximal stop for insertion section 1, is now the distal resistance force F A → E The first interface 45 is greater than the distal resistance force F L → E the second interface 47 (because t 4 > t 2 and η > β). As a result, the second counter groove 63 presses with the proximal ramp angle. β the second engagement element 55 together, so that it pushes past the proximal end 69 of the second counter groove 63 until the second interface 47 is disengaged and the protective sleeve 39 leaves the intended position proximally.

[0063] In Fig. 26 The second interface 47 is fully disengaged, and the protective sleeve 39 is pulled out of the receptacle 35 in the first axial position proximally with the first interface 45 engaged. The resistance force is... F L → E the second interface 47, which here is only generated by a sliding friction force, is significantly lower than the resistance force F A → E the first interface 45, due to the relatively high penetration depth t 4 and the relatively steep ramp angle ηThe first counter-groove 59 together effectively form a distal stop for the protective sleeve 39.

[0064] Fig. 27Figure 1 shows an alternative embodiment in which the engagement elements 53, 55 are an integral part of the protective sleeve 39. In other embodiments, it would also be conceivable for the first engagement element 53 to be an integral part of the insertion section 1 and / or the second engagement element 55 to be an integral part of the positioning element 33. Here, the first engagement element 53 of the first interface 45 is formed by at least one spring tongue arranged on the inside of the protective sleeve 39, which can engage or snap into a corresponding recess 59 on the outside of the insertion section 1. Preferably, the first engagement element 53 is formed by two or more spring tongues that are evenly distributed around the circumference.The at least one spring tongue 53 is hinged proximally and forms a relatively shallow proximal ramp angle, allowing the protective sleeve 39 to be moved proximally from the first axial position with respect to the insertion section 1, with the spring tongue 53 yielding radially outwards. Distally, the spring tongue 53 forms a stop that abuts a steep distal flank of the recess 59 when the protective sleeve 39 is pushed distally into the first axial position shown. This ensures that the protective sleeve 39 is captive and securely attached to the insertion section 1.

[0065] The second engagement element 55 could be formed analogously to the first engagement element 53 by one or more outwardly directed spring tongues. In the embodiment according to Fig. 27However, the second engagement element 55 is formed by a radial projection that extends outwards from an outer side of the protective sleeve 39 and engages in a second recess 63, which here corresponds to the second counter groove 63 according to the diagram in Figures 19 to 26The embodiment shown corresponds to the embodiment shown. Here, the protective sleeve 39 is slotted over a length s in a proximal end region, creating protective sleeve end sections 77 that have a radial distance a from the insertion section 1 and can thus be elastically bent inwards. This allows the engagement element 55 arranged on the protective sleeve end sections 77 to be elastically pressed inwards when the second interface 47 is engaged and disengaged. The radial distance a is selected such that it is greater than or equal to the proximal penetration depth t2 of the second engagement element 55 into the second recess 63, but less than the distal penetration depth t3 of the second engagement element 55 into the second recess 63. t 3 > a > t 2 applies. The engagement elements 53, 55 can themselves be elastically deformable, but they do not have to be. The engagement elements 53, 55 can simply be designed to be movable.

[0066] The numbered designations of the components or directions of movement as "first," "second," "third," etc., are chosen here purely arbitrarily to distinguish the components or directions of movement from one another and can be chosen differently at will. No ranking is implied. The designation of a component or technical feature as "first" should not be misinterpreted to mean that there must be a second component or technical feature of the same type. Furthermore, any process steps, unless explicitly stated otherwise or required by law, can be carried out in any order and / or with partial or complete temporal overlap.

[0067] Features described as optional, advantageous, preferred, desirable or similar, such as "may" features, are to be understood as optional and not as limiting the scope of protection.

[0068] The described embodiments are to be understood as illustrative examples and do not constitute an exhaustive list of possible embodiments. Each feature disclosed in relation to an embodiment may be used alone or in combination with one or more other features, regardless of the specific embodiment in which the features were described. Furthermore, the term "have" is not intended to exclude additional features or process steps, nor is "a" or "an" intended to exclude multiple features. Reference symbol list:

[0069] 1. Insertion section 3. Tissue to be examined / treated 5. Organic body 5a. Skin of the organic body 7. Active light-emitting element / LED 7a. Front of the LED 9. Needle tip 9a. Sleeve-shaped section of the needle tip 11. Conductor element 13. Connection point 15. Lateral force FL,S 17. Laterally acting external body 19. Release force 21. Light applicator 23. Handle element 25. Connecting cable 27. Operator's hand 29. Lateral force FL,H 31. Light applicator system 33. Positioning element 35. Receptacle 37. Fixing element 39. Protective sleeve 43. Light of the LED 45. First interface 47. Second interface 49. Joints 51. Treatment table 53. First intervention element 55. Second intervention element 57. First groove 59. First counter groove / recess 61. Second groove 63 Second counter groove / recess 65 Stop 6768 Ramp surfaces 69 Proximal end of the second counter groove / recess 71 Distal end of the second counter groove / recess 73 Proximal end of the first counter groove / recess 75 Distal end of the first counter groove / recess 77 Protective sleeve end sections d 1 Length of the insertion section without needle tip d 2 Length of the needle tip ZN Longitudinal axis of the insertion section Z Desired insertion direction FA Manual insertion or withdrawal force L Axial length of the receptacle t 1 Proximal penetration depth of the first engagement element t 2 Proximal penetration depth of the second engagement element t 3 Distal penetration depth of the second engagement element t 4 Distal penetration depth of the first engagement element aradial distance s Length of the protective sleeve end sections , α,β,γ,ε,η,δ Ramp angle F A → E Resistance of the first interface F L → E Resistance of the second interface

Claims

1. Light applicator system (31) for the examination and / or treatment of an organic body (5), wherein the light applicator system (31) has at least one light applicator (21) and a positioning element (33), wherein the light applicator (21) has a distal-side insertion section (1) with at least one active light-emitting element (7) at the distal end for the penetration of tissue (3) of the organic body (5), wherein the insertion section (1) has a needle tip (9), which, at least partially, is arranged distally from the at least one active light-emitting element (7), and tapers to a point in the distal direction, wherein the positioning element (33) can be fixed at least temporarily in a defined position and orientation relative to the organic body (5) and has at least one repository (35) for the at least one light applicator (21), in which the at least one light applicator (21) has, at least temporarily, a defined orientation relative to the organic body (5), characterised in that the light applicator (21) has a protective sleeve (39) which is axially movable relative to the insertion section (1); it encloses the needle tip (9) in a protective manner in a first axial position relative to the insertion section (1), and in a second axial position, determined by an axial position of the insertion section (1) relative to the positioning element (33), is pushed back in a proximal direction from the needle tip (9) relative to the insertion section (1), wherein the protective sleeve (39) serves as an insertion sleeve into the at least one repository (35) of the positioning element (33).

2. Light applicator system (31) in accordance with Claim 1, wherein the protective sleeve (39) has an outer diameter, which, at least in some sections, fits precisely into an inner diameter of the at least one repository (35) of the positioning element (33).

3. Light applicator system (31) in accordance with Claim 2, wherein at the distal end the outer diameter of the protective sleeve (39) tapers in the distal direction, and / or at the proximal end the inner diameter of the at least one repository (35) of the positioning element (33) widens in the proximal direction.

4. Light applicator system (31) in accordance with one of the preceding claims, wherein the insertion section (1) of the light applicator (21) is rigid, and in the axial direction (ZN) has a greater length than the protective sleeve (39).

5. Light applicator system (31) in accordance with one of the preceding claims, wherein the protective sleeve (39) is captively secured to the insertion section (1) of the light applicator (21).

6. Light applicator system (31) in accordance with one of the preceding claims, wherein on the proximal side the light applicator (21) has a handgrip element (23) for the manual positioning of the light applicator (21).

7. Light applicator system (31) in accordance with Claim 6, wherein the axial position of the insertion section (1) relative to the positioning element (33) can be adjusted manually by positioning of the handgrip element (23) in the axial direction (ZN).

8. Light applicator system (31) in accordance with one of the preceding claims, wherein when the light applicator (21) is inserted in the distal direction into the at least one repository (35) of the positioning element (33), the protective sleeve (39) is secured in the first axial position, until the protective sleeve (39) in the at least one repository (35) of the positioning element (33) achieves a desired position in the positioning element (33), in which the insertion section (1) can pushed in the distal direction out of the protective sleeve (39).

9. Light applicator system (31) in accordance with Claim 8, wherein when the light applicator (21) is pulled in the proximal direction out of the at least one repository (35) of the positioning element (33), the protective sleeve (39) is secured in the desired position in the positioning element (33) until the protective sleeve (39) assumes the first axial position with respect to the insertion section (1), in which the protective sleeve (39) can be pulled in the proximal direction out of the at least one repository (35) of the positioning element (33).

10. Light applicator system (31) in accordance with one of the preceding claims, further comprising an elastically deformable, and / or movable, engagement element (53), wherein the engagement element (53) is arranged between the insertion section (1) and the protective sleeve (39), such that, when an axial force is overcome, it yields elastically or moves to an extent such that the protective sleeve (39) can reach the first axial position in the distal direction, and / or leave it in the proximal direction.

11. Light applicator system (31) in accordance with Claim 10, wherein the engagement element (53) is a first of at least two elastically deformable and / or movable engagement elements (53, 55), with a second engagement element (55), and the axial force is a first axial force of at least two axial forces, with a second axial force, wherein the second engagement element (55) is arranged between the protective sleeve (39) and the at least one repository (35) of the positioning element (33) such that, when the second axial force is overcome, it yields elastically, or moves to an extent such that the protective sleeve (39) can reach the desired position in the positioning element (33) in the distal direction, and / or leave it in the proximal direction.

12. Light applicator system (31) in accordance with Claim 10 or 11, wherein the first engagement element (53) is part of the protective sleeve (39) and / or the insertion section (1).

13. Light applicator system (1) in accordance with one of the Claims 10 to 12, wherein the second engagement element (55) is part of the protective sleeve (39) and / or the positioning element (33).

14. Light applicator system (1) in accordance with one of the Claims 10 to 13, wherein in the distal direction, the first axial force is greater than the second axial force, and in the proximal direction, the second axial force is greater than the first axial force.