Light irradiation system with protective sleeve

Abstract

The present disclosure relates to a light irradiation system (31) for the examination and / or treatment of an organic being (5), wherein the light irradiation system (31) has at least one light irradiator (21) and a positioning element (33), wherein the light irradiator (21) has on a distal end a distal-side insertion portion (1) with at least one active light emitting element (7) for piercing into tissue (3) of the organic being (5), wherein the insertion portion (1) has a needle tip (9) which is arranged at least partially away from the at least one active light emitting element (7) and which tapers distally, wherein the positioning element (33) is at least temporarily fixable in a defined position and orientation relative to the organic being (5) and has at least one accommodation (35) for the at least one light irradiator (21), the at least one light irradiator (21) having in the accommodation at least temporarily a defined orientation relative to the organic being (5), wherein the light irradiator (21) has an axially movable protective sleeve (39) relative to the insertion portion (1), which in a first axial position relative to the insertion portion (1) protectively surrounds the needle tip (9) and which in a second axial position relative to the insertion portion determined depending on the axial position of the insertion portion (1) relative to the positioning element (33) is pushed back proximally from the needle tip (9), wherein the protective sleeve (39) serves as an insertion sleeve in the at least one accommodation (35) of the positioning element (33).

Description

Technical Field

[0001] This disclosure relates to a light irradiation system for the examination and / or treatment of organic organisms, and in particular to photodynamic therapy (PDT) for pathological tissues. Background Technology

[0002] As is well known, endoscopes are used for video recording of the inside of the human or animal body for medical diagnosis and / or treatment. In order to visualize the smallest possible cavities and minimize tissue impact, ongoing efforts are needed to design the insertion portion of the endoscope to be as thin as possible.

[0003] However, endoscopes are not only used for image or video recording, but also as diagnostic or therapeutic devices. For example, for the detection and localization of early-stage and malignant tissues, fluorescence endoscopy can be used, where the natural true color of the tissue is not important; what matters is fluorescence excitation, which distinguishes pathological tissue from healthy tissue. Here, the pathological tissue itself, or the bacterial aggregation indicating the pathological tissue, excited by light radiation can specifically fluoresce and thus be identifiable and localized relative to the surrounding healthy tissue. For example, within the framework of photodynamic diagnosis (PDD) and / or photodynamic therapy (PDT), fluorescence endoscopy can be achieved using photosensitizers or labeling substances that selectively accumulate on pathological tissues.

[0004] In photodynamic therapy (PDT), light is applied directly to, or even within, pathological tissue via a photoirradiator. This aims to photoinducibly promote the formation of oxygen free radicals through locally concentrated photosensitizers or labeled substances, thereby destroying the pathological tissue, such as tumors. For this purpose, a laser is typically coupled into a photoconductor and conducted to the tissue. If the pathological tissue is flat on an outer surface (e.g., skin) or an inner surface (e.g., the lining of the esophagus or intestinal wall), the therapeutic light can be relatively easily coupled out and radiated onto the surface of the pathological tissue. However, if the pathological tissue has a certain volume, it cannot always effectively radiate the tumor from the "outside" due to the limited penetration depth of the light into the tissue. In such cases, PDT is particularly effective when the light is emitted as isotropically as possible from within the volume of the pathological tissue. For this, the photoirradiator must be inserted into the pathological tissue. This is also known as interstitial (through the inner surface) and / or percutaneous (through the skin) PDT.

[0005] For example, patent document US6048359 describes how to insert multiple light irradiators into pathological tissue by means of a positioning grating.

[0006] The drawback of these known technical solutions is that the extremely sharp tip of the irradiator is dangerously sharp to the user and is also prone to breakage during the operation before it is actually inserted into the patient's skin. Summary of the Invention

[0007] The resulting task is to provide a light irradiator in which the sharp and sensitive therapeutic tip is protected until actual insertion, so that it does not endanger the user and does not break before actually penetrating the patient's skin.

[0008] To address this problem, this disclosure provides a light irradiation system for examining and / or treating an organism, wherein the light irradiation system has at least one light irradiator and a positioning element; wherein the light irradiator has a distal-side insertion portion at its distal end, the distal-side insertion portion having at least one active light-emitting element, such as an LED, for inserting into the tissue of the organism; wherein the insertion portion has a needle tip arranged at least partially away from the at least one active light-emitting element and gradually tapering towards the distal end; wherein the needle tip can be configured as a light-scattering element for scattering light emitted in the distal-side direction; wherein the positioning element can be at least temporarily fixed relative to... The device is positioned and oriented in a manner defined by an organic organism, and has at least one receptacle for at least one light irradiator, which at least temporarily has an orientation defined relative to the organic organism in the receptacle; wherein the light irradiator has a protective sleeve that is axially movable relative to an insertion portion, the protective sleeve protectively surrounding the needle tip at a first axial position relative to the insertion portion, and being pushed back from the needle tip toward the proximal side at a second axial position relative to the insertion portion (1) determined according to an axial position of the insertion portion (1) relative to the positioning element; wherein the protective sleeve is used as an insertion sleeve for secure insertion into at least one receptacle of the positioning element.

[0009] Therefore, the light irradiator disclosed herein does not use a laser light conductor. Instead, diagnostic or therapeutic light is generated in situ at the distal end of the light irradiator by an active light-emitting element (e.g., a miniaturized LED), for example, having a lateral width of less than 1 mm. Here, "active" means that the light-emitting element absorbs electrical energy and converts it into light, i.e., it is not simply conducted as a light conductor. Therefore, expensive lasers are not required, thus greatly reducing costs. The light irradiator disclosed herein, or at least its insertion part, can be manufactured very inexpensively and thus realized as a sterile, disposable product, eliminating the need for laborious cleaning and sterilization by the user. For larger tumors or entire pathological organs or organ regions, the light irradiation system can have multiple light irradiators that are simultaneously used for PDT by being distributed and inserted throughout the organ to uniformly irradiate the entire organ. Since the photosensitizer or labeling substance is selectively enriched only in the pathological tissue and reacts there under the influence of light, healthy tissue is not damaged by the light. Accordingly, on the one hand, it is no longer necessary to precisely locate the pathological tissue beforehand, and on the other hand, the risk of neglecting treatment due to overlooking pathological tissue is reduced.

[0010] For percutaneous PDT with multiple light irradiators, it is meaningful that the positioning element has multiple receptacles and forms an organ-specific template that can be positioned and / or adhered to the patient's skin in a defined manner to show the user the irradiator's insertion site, angle, and / or depth and to achieve the most complete and substantially uniform irradiation of the organ.

[0011] However, light irradiators can be used not only for treatment but also for examination, i.e., diagnosis. In particular, when used in conjunction with an endoscope or as part of an endoscope, the fluorescence produced by the light irradiator on photosensitizers or labeled substances enriched in pathological tissues can be observed.

[0012] Optionally, the protective sleeve may at least partially have an outer diameter that precisely matches the inner diameter of at least one receiving portion of the positioning element. This allows the protective sleeve to be precisely coaxially oriented within at least one receiving portion of the positioning element and prevents possible pivoting. As long as the protective sleeve is located within the at least one receiving portion of the positioning element, the light irradiator will only move axially. Preferably, the protective sleeve is pushed into the at least one receiving portion of the positioning element towards the distal end until the protective sleeve reaches an axially target position, which is preferably the position of the protective sleeve at its maximum distal end. For example, the protective sleeve is pushed into the distal end... It is pushed into at least one receiving portion of the positioning element, and when it reaches the target position, it can be stopped by a stop and abut against the positioning element.

[0013] Optionally, the outer diameter of the protective sleeve may taper gradually toward the distal end, and / or the inner diameter of at least one receiving portion of the positioning element may expand toward the proximal end. This facilitates the insertion of the protective sleeve into the receiving portion of the positioning element.

[0014] Optionally, the insertion portion of the light irradiator may be rigid and have a greater length in the axial direction than the protective sleeve. The insertion portion preferably corresponds to a rigid needle that is as thin as possible, on which a small LED is arranged in or above the light-scattering tip.

[0015] Optionally, the protective sleeve can be securely attached to the insertion portion of the light irradiator. Thus, the protective sleeve protects the needle tip even outside of practical applications, such as during transport and / or cleaning of the light irradiator.

[0016] Optionally, the light irradiator may have a handle element on its proximal side for manually positioning the light irradiator. This handle element can be used for orienting the light irradiator outside the positioning element, provided that the orientation via the inserted protective sleeve within the positioning element has not yet been determined. The handle element may be fixedly connected to or detachably coupled to the insertion part. The handle element may be reusable if necessary, and the decoupled insertion part may be designed as a disposable item.

[0017] Optionally, when the distal end of the light irradiator is inserted into at least one receptacle of the positioning element, the protective sleeve can be held in a first axial position for an extended period until the protective sleeve reaches a target position within the positioning element, at which point the insertion portion can be pushed out of the protective sleeve distally. Preferably, the target position is the maximum distal position of the protective sleeve within the receptacle of the positioning element. Preferably, at the target position, the protective sleeve is completely or at least substantially located within and locked within the receptacle of the positioning element.

[0018] Optionally, when the light irradiator is pulled out from at least one receiving portion of the positioning element from the proximal side, the protective sleeve can be fixed in the target position in the positioning element for a long time until the protective sleeve occupies a first axial position relative to the insertion portion, in which the protective sleeve can be pulled out from at least one receiving portion of the positioning element from the proximal side.

[0019] Optionally, the light irradiation system may also have an elastically deformable and / or movable engagement element, wherein the engagement element is arranged between the insert and the protective sleeve such that the engagement element elastically buckles or moves against axial force, i.e., the protective sleeve moves to a first axial position distally and / or moves away from the first axial position proximally. Optionally, the first engagement element may be part of the protective sleeve and / or the insert.

[0020] Optionally, the light irradiation system may have an additional elastically deformable and / or movable engaging element, wherein a second engaging element is arranged between the protective sleeve and at least one receiving portion of the positioning element, such that the second engaging element elastically buckles or moves in the face of a second axial force, i.e., the protective sleeve may move distally to the target position in the positioning element and / or proximally away from the target position in the positioning element. Optionally, the second engaging element may be part of the protective sleeve or the positioning element.

[0021] Optionally, the first axial force may be greater than the second axial force toward the distal end; and the second axial force may be greater than the first axial force toward the proximal end.

[0022] The term "remote" "and proximal end" "Here, it refers to the position farthest from the system user compared to the reference position. The terms 'distal side' or 'proximal side' refer to the corresponding position on the far side or near side of the object. The term 'towards the far side'..." "and "towards the proximal end" "Here, it refers to the corresponding directions extending into the distance and into the near future." Attached Figure Description

[0023] The present disclosure will now be described in detail with reference to the embodiments shown in the accompanying drawings. Wherein:

[0024] Figure 1a Figures 1 and 2 show two schematic longitudinal cross-sectional views of the tip of the insertion portion of a light irradiation system according to an embodiment of the present disclosure;

[0025] Figure 2 It shows according to Figure 1a A schematic longitudinal cross-sectional view of the needle tip of the insertion part in the illustrated embodiment under lateral force;

[0026] Figure 3a Figures 1 and 2b show two schematic longitudinal cross-sectional views illustrating the occurrence of lateral force when using the light illumination system of this disclosure;

[0027] Figure 4 A schematic longitudinal cross-sectional view of a light irradiation system according to an embodiment of the present disclosure is shown before the light irradiator is inserted into the positioning element;

[0028] Figure 5 A schematic longitudinal cross-sectional view of a light irradiation system according to an embodiment of the present disclosure is shown when it is tilted during the insertion of a light irradiator into a positioning element;

[0029] Figure 6A schematic longitudinal cross-sectional view of a light irradiation system according to an embodiment of the present disclosure is shown in a first axial position relative to the insertion portion when the light irradiator is inserted into a positioning element with a protective sleeve.

[0030] Figure 7 A schematic longitudinal cross-sectional view of a light irradiation system according to an embodiment of the present disclosure is shown when an insertion part is inserted into the body;

[0031] Figure 8 A schematic longitudinal cross-sectional view of a light irradiation system according to an embodiment of the present disclosure is shown when the insertion portion pierces the body and when it pierces tissue requiring examination / treatment.

[0032] Figure 9 A schematic longitudinal cross-sectional view of a light illuminator of a light illumination system according to an embodiment of the present disclosure is shown;

[0033] Figure 10 A schematic longitudinal cross-sectional view of a protective sleeve in a positioning element of a light irradiation system according to an embodiment of the present disclosure is shown; the light irradiator is not shown here.

[0034] Figure 11 A schematic longitudinal cross-sectional view of a light irradiation system according to an embodiment of the present disclosure is shown when an insert is inserted into the body, wherein the protective sleeve is not in a first axial position relative to the insert;

[0035] Figure 12 A schematic longitudinal cross-sectional view is shown of a light irradiator according to an embodiment of the present disclosure, when the protective sleeve is in a first axial position relative to the insertion portion during insertion of the positioning element and before the protective sleeve has reached the axial target position in the positioning element.

[0036] Figure 13 A schematic longitudinal cross-sectional view of a light irradiator according to an embodiment of the present disclosure is shown when the protective sleeve is in a first axial position relative to the insertion portion during the insertion of the positioning element, wherein the protective sleeve has just reached the axial target position in the positioning element.

[0037] Figure 14 A schematic longitudinal cross-sectional view of a light irradiator according to an embodiment of the present disclosure is shown when the tip of the insertion part is pressed into the body from the distal end of a protective sleeve located at an axial target position in the positioning element.

[0038] Figure 15 A schematic longitudinal cross-sectional view of a light irradiator according to an embodiment of the present disclosure is shown when the needle tip of the insertion part is pulled out from the proximal end of the body into a protective sleeve located at an axial target position in the positioning element.

[0039] Figure 16A schematic longitudinal cross-sectional view of a light irradiator according to an embodiment of the present disclosure is shown when it is pulled out from a positioning element, wherein the protective sleeve has just occupied a first axial position relative to the insertion portion, but is still in an axial target position relative to the positioning element.

[0040] Figure 17 A schematic longitudinal cross-sectional view is shown of a light irradiator according to an embodiment of the present disclosure, with the protective sleeve in a first axial position relative to the insertion portion during pull-out from the positioning element and after the protective sleeve has moved proximally away from the axial target position in the positioning element.

[0041] Figure 18 A schematic longitudinal cross-sectional view of a light irradiation system according to an embodiment of the present disclosure is shown to illustrate the fixation of the positioning element relative to the patient's body;

[0042] Figures 19 to 26 A light illumination system according to one embodiment of the present disclosure is shown, similar to Figures 11 to 17 Schematic longitudinal cross-sectional views of the details when the surface is located at different positions of the light illuminator; and

[0043] Figure 27 A schematic longitudinal cross-sectional view of a light illumination system according to an alternative embodiment of the present disclosure is shown. Detailed Implementation

[0044] Figure 1a , 1b Figures 2, 3a, and 3b illustrate the problems solved by using the light illumination system of this disclosure. Figure 1a and Figure 1b Different embodiments of the distal end of the insertion portion 1 of the light irradiator in the light irradiation system according to this disclosure are shown. This distal end is used to penetrate the tissue 3 of the organic organism 5 (see...). Figure 3a and Figure 3b This allows for photodynamic therapy (PDT) or diagnostic imaging (PDD) of the tissue 3 by irradiating it with light. To achieve the most minimally invasive treatment or diagnosis possible, the insertion part 1 of the light irradiator is constructed to be needle-shaped, as thin as possible (diameter less than 2 mm), and rigid.

[0045] The distal end of the insertion portion 1 exemplarily has an active light-emitting element 7 in the form of an LED, the main radiation direction of which points in the longitudinal direction Z of the insertion portion 1. N A needle tip 9, which tapers towards the distal end and is arranged at least partially away from the LED 7, has a light-transmitting diffuser for scattering the light from the LED 7. The needle tip 9 is essentially integrally formed of the light-transmitting diffuser, which may, for example, be a plastic with one or more reinforcing elements.

[0046] LED 7 is disposed on the distal end face of conductor element 11. Conductor element 11 is constructed as a solid metal rod. Conductor element 11 can serve both as an electrical conductor supplying power to LED 7 and as a thermal conductor dissipating heat generated by LED 7 towards the proximal end. For this purpose, the core of conductor element 11 can, for example, be copper, which has good thermal and electrical conductivity. To reinforce conductor element 11, which may have a diameter of 1 mm or less, the sheath of conductor element 11 can be made of a bending-rigid material, such as steel. When the core and sheath of conductor element 11 are electrically insulated from each other, for example by a thin insulating layer located between them, the core and sheath can act as a feed-return conductor pair supplying power to LED 7.

[0047] like Figure 1a and Figure 1b As shown, the cross-sectional area of ​​the conductor element 11 is only slightly larger than that of the LED 7. To prevent the tip 9 from being solely fixed to the end face 7a of the LED 7, and also to prevent the tip 9 from extending beyond the cross-section of the conductor element 11, the tip 9 has a sleeve-like portion 9a on its proximal side. This sleeve-like portion surrounds the LED 7 circumferentially, and the tip 9 is directly connected to the end side of the conductor element 11. The tip 9 is connected to the LED 7 and the conductor element 11 via a planar connection point 13, preferably through a material-fit connection along the connection point 13. To enlarge the planar connection point 13 located directly between the tip 9 and the conductor element 11, in Figure 1b In the illustrated embodiment, the proximal sleeve-shaped portion 9a is configured to be axially longer, and the conductor element 11 has a correspondingly tapering distal portion, which is surrounded circumferentially by the sleeve-shaped portion 9a of the needle tip 9. Thus, the needle tip 9 can be bonded not only directly to the conductor element 11 at the end but also circumferentially to the tapering distal portion of the conductor element 11. This results in a larger and stronger connection point 13.

[0048] Right now, Figure 2 This illustrates that the needle tip 9 may be prone to detachment or breakage. Since the needle tip 9 must be as sharp as possible for minimally invasive procedures or treatments, it is preferably oriented in the longitudinal direction Z. N The upper part is significantly longer than its diameter. Now, if an external body 17 applies a lateral force F to the distal tip of the needle 9... L,S 15, then the lever action increases the separation force. 19 acts at connection point 13, potentially causing the connection point to tear as shown in the figure. For according to Figure 1b This implementation method also carries the same risk, even though connection point 13 would theoretically be stronger there. However, according to... Figure 1a and Figure 1bThere is also a risk in the two embodiments that the proximal sleeve portion 9a may break off from the rest of the needle tip 9 because the sleeve portion 9a can only be constructed very thinly.

[0049] Figure 1a , 1b Figures 2 and 3 exemplarily illustrate one embodiment in which the active light-emitting element is a single LED 7 disposed on the distal end face of the conductor element 11. Instead of a single LED 7, multiple active light-emitting elements may be used, and in this case, other active light-emitting elements, such as laser diodes, may also be used. Instead of being disposed on the distal end face of the conductor element 11, the at least one active light-emitting element may also be positioned on the distal insertion portion 1 of the light irradiator 21 or on the side of the conductor element 11. Furthermore, the needle tip 9 does not necessarily have to be a separate component bonded to the distal end of the insertion portion 1. Instead, the needle tip 9 may be a continuation of the conductor element 11. Accordingly, an important task is to protect users and patients from accidental contact with the sharp needle tip 9 and the potential injury resulting therefrom. In the embodiments described below, the LED 7 disposed, for example, on the distal end face of the conductor element 11, and the needle tip 9 applied, for example, bonded to the distal side, which is configured as a diffuser, will be considered.

[0050] Figure 3a and Figure 3b This demonstrates how a lateral force F can be generated on the needle tip 9 during the use of the light illumination system 21 of this disclosure. L,S 15. The light irradiation system has a light irradiator 21, which includes an insertion part 1, a handle element 23, and a power supply unit (not shown) that can be connected via a connecting cable 25.

[0051] The operator grasps the handle element 23 with hand 27 to insert the insertion part 1 into the patient's body 5 by piercing the skin 5a along the direction of the tissue 3 to be examined or treated. Figure 3a and Figure 3b The dimensions are schematically shown in the diagram and cannot be shown to scale here. Here, the insertion part 1 has a relatively large length d1+d2 from the distal end of the needle tip 9 to the handle element 23, for example, 20 cm or longer, and is very slender, for example, having a diameter of 1 mm or less. The length of the needle tip 9 is represented here by d2, and the length of the remaining portion of the insertion part 1 is represented by d1, where d1 >> d2. If the operator applies only a relatively small lateral force F on the handle element 23... L,H 29, then according to the lever principle, a relatively large lateral force F is obtained on the needle tip 9 according to this size ratio. L, S15. In the case shown, the needle is first inserted perpendicularly into the skin 5a along the Z direction, but subsequently the light irradiator 21 will be subject to relatively small lateral hand force F on the handle element 23 during manual operation. L,H 29. And slightly bent. Then, subsequently, there will be a much larger lateral force F. L,S 15 acts on the needle tip 9, because Therefore, the lateral force F L,S 15 may cause the needle tip 9 to detach or break.

[0052] Figure 4 A light irradiation system 31 is shown, which significantly reduces the risk of needle tip 9 detachment or breakage. The light irradiation system 31 has a light irradiator 21 with an insertion portion 1, a needle tip 9 at a distal end, and a handle element 23 at a proximal end. Furthermore, the light irradiation system 31 has a positioning element 33 that can be fixed, at least temporarily, in a defined position and orientation relative to the organic organism 5. Figure 4 As schematically shown, the positioning element 33 may be at a distance from the skin 5a, or it may be arranged to directly contact the skin 5a, for example, by adhering it to the skin 5a. The positioning element 33 may be a template having at least one receiving portion 35 for a light irradiator 21. The receiving portion 35 may be a recess or hole in the positioning element 33 that defines an insertion point on the skin 5a in a plane orthogonal to the perpendicular insertion direction Z. Preferably, multiple receiving portions 35 are arranged in this plane orthogonal to the perpendicular insertion direction Z so that the operator can select from predetermined and / or simultaneously use multiple light irradiators 21. The positioning element 33 and the patient's body 5 are preferably fixed or fixable relative to each other by a fixing element 37, preferably both relative to a fixed local reference body (e.g., a treatment table).

[0053] The positioning element 33 has a certain thickness L in the axial insertion direction Z, such that the receiving portion 35 has a length L in the axial direction Z. Through this length L, the positioning element 33 not only defines the position of the insertion point but also defines the orientation of the light irradiator 21 relative to the body 5. Figure 4 In the case shown, the receiving portion 35 only allows vertical insertion into the skin 5a. For this purpose, it is preferable to construct the positioning element 33 as rigid and non-flexible.

[0054] Because the needle tip 9 tilts during the manual insertion of the insertion part 1 into the rigid and non-flexible positioning element 33 (see... Figure 4 The risk of detachment or breakage is even greater than that of... Figure 3a and Figure 3bTo mitigate the risks of direct, tilted insertion into the skin 5a without the positioning element 33, the light irradiation system 31 includes a protective sleeve 39. The protective sleeve 39 is axially movable relative to the insertion portion 1, but is temporarily fixed in at least one first axial position relative to the insertion portion 1. Figure 4 In the first axial position relative to the insertion portion 1, the protective sleeve 39 protectively surrounds the needle tip 9. The protective sleeve 39 protrudes axially from the distal end of the needle tip 9 in the illustrated first axial position. This protects not only the needle tip 9 but also the patient and / or operator from accidental puncture by the very sharp needle tip 9. The protective sleeve 39 is thus securely attached to the insertion portion 1 of the light irradiator 21, preventing it from falling off or being pulled out distally from the insertion portion 1. Figure 4 The first axial position shown is the maximum distal axial position relative to the insertion portion 1 of the light irradiator 21. Along the proximal direction, the handle element 23 or another stop (not shown here) can limit the maximum axial movement freedom of the protective sleeve 39 along the insertion portion 1.

[0055] The inner diameter of the receiving portion 35 is precisely fitted to the outer diameter of the protective sleeve 39, thereby allowing the protective sleeve to be precisely inserted into the receiving portion 35 of the positioning element 33 in the axial direction Z. To facilitate insertion into the receiving portion 35, the outer diameter of the protective sleeve 39 gradually tapers towards the distal end of the protective sleeve 39.

[0056] Figure 5 This demonstrates how the protective sleeve 39 protects the needle tip 9 from large lateral forces F. L,S The effect of 15, the lateral force F L,S 15 has been achieved by a relatively small manual tilting force F on the handle element 23. L,H Caused by 29. 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 many times. The axial length of the protective sleeve 39 is at least equal to half the length L of the receiving portion 35, and in this case, they are substantially equal.

[0057] exist Figure 6 In this configuration, the insertion part 1 is inserted into the receiving part 35 of the positioning element 33 along with the protective sleeve 39, thereby precisely orienting the light irradiator 21 perpendicular to the skin 5a along the Z direction. The protective sleeve 39 remains in a first axial position relative to the insertion part 1, in which the protective sleeve protectively surrounds the needle tip 9. To further advance the insertion part 1, the operator must manually apply an axial force F to the handle element 23. A Possible manual tilting force F on handle element 23 L,H 29 will only cause bending of the insertion part 1, but will not exceed the lateral force F on the needle tip 9 protected by the protective sleeve 39. L,S 15.

[0058] exist Figure 7 In the middle, the needle tip 9 of the insertion part 1 has pierced the skin 5a. However, here, the protective sleeve 39 is... Figure 6 The position shown is where it remains in the receiving portion 35 of the positioning element 33. The protective sleeve 39 may, for example, have a stop ( Figure 7 (Not shown in the image), the stop member defines the maximum distal position of the protective sleeve 39 within the receiving portion 35 of the positioning element 33 by abutting against the positioning element 33. By pressing the insertion portion 1 out of the protective sleeve 39 at its distal end, the protective sleeve 39 has moved away from the first axial position relative to the insertion portion 1 and is now in a second axial position, which is axially pulled back relative to the needle tip 9. Several second axial positions can exist, where each second axial position depends on the insertion depth of the needle tip 9 within the body 5, the maximum of which is limited only by the length of the insertion portion 1, i.e., reached only when the handle element 23 strikes the positioning element 33.

[0059] exist Figure 8 In this process, the needle tip 9 penetrates the tissue 3 and reaches the axial target position where PDD or PDT can be performed. That is, the LED 7 is turned on, and the needle tip 9, having a light-scattering body, scatters the light 43 of the LED 7 into the tissue 3 at a spatial angle that is as large as possible, preferably significantly exceeding 3π. The tissue 3 may be, for example, a tumor or other pathological tissue, which reacts to the light 43 of the LED 7, with or without the photosensitizer enriched therein, thereby generating localized, limited toxic substances, such as oxygen free radicals, that damage the pathological tissue 3. Since this process requires a certain radiation time, it is preferable to fix the insertion part 1 relative to the positioning element 33 in a selected second axial position. For this purpose, a clamping element, for example not shown here, can clamp the protective sleeve 39 to the insertion part 1. Additionally, this clamping element can also clamp the protective sleeve 39 to the positioning element 33.

[0060] Figure 9 The light irradiator 21 is shown schematically enlarged, but its length does not correspond to the paper when magnified to scale, and is therefore shown in shortened form. The inner diameter of the protective sleeve 39 is precisely fitted to the outer diameter of the insertion portion 1. The protective sleeve 39 protectively surrounds the needle tip 9 in a first axial position relative to the insertion portion 1. The handle element 23 is located at the proximal end of the light irradiator 21. At the distal end of the protective sleeve 39, the sleeve is beveled on the outside, i.e., the outer diameter gradually tapers towards the distal end, making it easier for the protective sleeve to be inserted into the receiving portion 35 of the positioning element 33.

[0061] exist Figure 10The image shows a protective sleeve 39 located within the receiving portion 35 of the positioning element 33, the sleeve fitting precisely within the receiving portion. Here, the length of the protective sleeve 39 is substantially equal to the thickness L of the positioning element, which corresponds to the axial length L of the receiving portion 35, thereby achieving good guidance.

[0062] Figure 11 The diagram illustrates a problem that occurs when the protective sleeve 39 is not properly positioned in the receiving portion 35 of the positioning element 33 and has simultaneously moved out of the first axial position. This can happen during insertion when the protective sleeve 39 touches the positioning element 33 with its distal end and the needle tip 9 is extruded from the protective sleeve 39 toward the distal end. Similarly, this can also occur when the irradiator 21 is pulled back proximally: that is, the protective sleeve 39 is prematurely pulled out of the receiving portion 35 of the positioning element 33 toward the proximal end before the needle tip 9 is pulled into the protective sleeve 39, placing the protective sleeve 39 in a protective first axial position. Because the inner diameter of the receiving portion 35 is adapted to the outer diameter of the protective sleeve 39, and the outer diameter of the protective sleeve is larger than the outer diameter of the insert 1, the insert 1 has a significant lateral gap in the receiving portion 35 when the protective sleeve 39 is not properly positioned. Figure 11 As shown, the light illuminator 21 may be tilted such that the longitudinal axis Z N It is no longer aligned with the set insertion direction Z. The result, as described above, is that there may be a considerable lateral force F. L,S 15 is applied to the needle tip 9, which may cause the needle tip 9 to detach or break.

[0063] exist Figures 12 to 17 The axial force relationship is shown, which advantageously dominates in the light illumination system 31 disclosed herein. In such... Figure 12 When the protective sleeve 39 is inserted into the receiving portion 35, it remains in a first axial position. To achieve this, the protective sleeve 39 has a first mechanical interface 45 leading inward to the insertion portion 1 and a second mechanical interface 47 leading outward to the positioning element 33. Interfaces 45 and 47 can be, for example, friction surfaces or friction points. Interfaces 45 and 47 respectively generate a thrust F in the opposite direction to the axial direction. A The resistance, such as static friction and / or sliding friction. As long as the protective sleeve 39 has not reached its final maximum distal position in the receiving portion 35, the resistance F generated by the second interface 47... L→E Less than the penetration force F A Conversely, the resistance F generated by the first interface 45 A→E Greater than the resistance F generated by the second interface 47 L→E Therefore, the protective sleeve 39 remains in the first axial position relative to the insertion part 1, and is resisted by the resistance F. A→E The piercing force F AThe resistance is transmitted to the protective sleeve 39. Therefore, the protective sleeve 39 overcomes the relatively small resistance F. L→E Move toward the far end into the receiving section 35.

[0064] exist Figure 13 The image shows the moment when the protective sleeve 39 reaches its final distal position, i.e., the target position, within the receiving portion 35, while still remaining in the first axial position relative to the insertion portion 1. The protective sleeve 39 may, for example, just abut against the positioning element 33 using a stop (not shown). This stop can be understood as part of the second interface 47, where the proximal resistance F during stopping... L→E Immediately increase to a level greater than the proximal side resistance F A→E The degree to which this is achieved. That is, since the positioning element 33 is fixed relative to the body 5, the protective sleeve 39 cannot be further pressed toward the distal end. Figure 12 In comparison, the operator must increase the penetration force F A To overcome the greater resistance F of the first interface 45 A→E To press the needle tip 9 toward the distal end to push out the protective sleeve 39.

[0065] exist Figure 14 In the process, by pressing the insertion part 1 toward the distal end out of the protective sleeve 39 located at the maximum distal position, i.e., the target position, the protective sleeve 39 has moved away from the first axial position. Once the initial high resistance F of the first interface 45 in the first axial position is reached... A→E If overcome, then the resistance F A→E It may be smaller outside the first axial position, thus allowing for further forward thrusts, such as Figure 14 As shown in , the penetration force F A It can also be smaller. For example, the initial high resistance F A→E It may include static friction and / or elastic deformation force. If the static friction is converted into a smaller sliding friction and / or the elastic deformation force is no longer needed, then the resistance F A→E It can be reduced in size. During and after penetration of the skin 5a and body 5, there is additional resistance reacting to the penetration force F. A This resistance must be sufficiently high to allow the needle tip 9 to penetrate the tissue 3. However, in order to make the puncture as minimally invasive as possible, the insertion portion 1 should be as thin as possible within stability limits, and the needle tip 9 should be as sharp as possible, so that the resistance caused by the skin 5a and / or body 5 is minimized as much as possible.

[0066] exist Figure 15 In the middle, after completing PDD or PDT, the insertion part 1 is retracted from the body 5 towards the proximal end. The protective sleeve 39 is locked here in the maximum distal position, so that the distal resistance F generated by the second interface 47 L→E Greater than the distal resistance F generated by the first interface 45 A→EThus, when the needle tip 9 is retracted back into the protective sleeve 39 towards the proximal end, the protective sleeve 39 is held in the maximum distal position, i.e., the target position, in the receiving portion 35 of the positioning element 33.

[0067] exist Figure 16 In the middle, the needle tip 9 retracts proximally into the protective sleeve 39, so that the protective sleeve 39 is again in a protective first axial position relative to the insertion part 1. The first interface 45 may have a stop that blocks the insertion part 1 at its maximum proximal position relative to the protective sleeve 39, so that the distal resistance F A→E Greater than the distal resistance F generated by the locked second interface 47 L→E The operator must increase the proximal pull-out force F. A To overcome the far-end resistance F L→E This releases the second interface 47 from the latch. Subsequently, the protective sleeve 39 moves proximally away from its target position in the receiving portion 35 and remains in the first axial position relative to the insertion portion 1.

[0068] Once the lock on the second interface 47 is released, such as Figure 17 As shown, the pulling force F A Overcoming the small sliding friction force F of the second interface 47 L→E This allows the protective sleeve 39, located in a protective first axial position relative to the insertion portion 1, to be easily pulled out proximally from the receiving portion 35. The needle tip 9 remains protected by the protective sleeve 39 in the first axial position. Similarly, the protective sleeve 39 also protects the operator and / or patient from accidental puncture by the needle tip 9.

[0069] Figure 18 The fixation of the positioning element 33 relative to the patient's body 5 is shown more precisely. The fixation element 37 here has an articulated arm with multiple joints 49, wherein the positioning element 33 can be fixed to be arbitrarily positioned in preferably six degrees of freedom, i.e., along three spatial directions x, y, z, and arbitrarily oriented at three angles. The treatment table 51 here serves as a local reference surface, relative 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 occupies a defined fixed position above or on it. The positioning element 33 can be abutted distally against the skin 5a of the body 5. Preferably, the positioning element 33 is even adhered to the skin 5a.

[0070] The positioning element 33 can be a perforated plastic plate in the form of a perforated plate or a perforated grid. To guide the orientation of the protective sleeve 39 in a defined manner, it is advantageous for the receiving portion 35 to extend a certain length L in the Z direction. For this purpose, the positioning element 33 can have a corresponding thickness L. Alternatively, each receiving portion 35 can have a sleeve extension (Hülsenfortsatz) extending proximally in the Z direction, which is fixedly or detachably connected to the positioning element 33, so that the positioning element 33 does not have to be designed to be large and heavy. However, for a specific application, a large and heavy design of the positioning element 33 may also be advantageous.

[0071] exist Figures 19 to 26 The working principle of interfaces 45 and 47 is explained more precisely according to one embodiment. In the illustrated embodiment, interfaces 45 and 47 each have one or more elastically deformable engagement elements 53 and 55, in the form of O-rings. The first engagement element 53 of the first interface 45 is located between the insertion portion 1 and the protective sleeve 39, and has a radially outer portion located in a first groove 57 that is arranged inside the protective sleeve 39 and radially surrounds it. Figure 19 In the first axial position of the protective sleeve 39 shown, the radially inner portion of the first engaging element 53 (which is smaller than the radially outer portion) is located in the first mating groove 59, which is arranged outwardly on the insertion portion 1 and radially surrounds it. The second engaging element 55 of the second interface 47 is located between the protective sleeve 39 and the positioning element 33, and has a radially inner portion located in the second groove 61, which is arranged outwardly on the protective sleeve 39 and radially surrounds it. Figures 21 to 25 At the maximum distal position of the protective sleeve 39 relative to the receiving portion 35, i.e., the target position, the radially outer portion of the second engaging element 55 (which is smaller than the radially inner portion) is located in the second mating groove 63, which is arranged inwardly on the receiving portion 35 of the positioning element 33 and radially surrounds it. Once the engaging elements 53, 55 are in the corresponding mating grooves 59, 63, the corresponding interfaces 45, 47 are "locked," i.e., the corresponding resistance F is engaged. L→E or F A→E It will temporarily increase.

[0072] like Figure 19 As shown, when the protective sleeve 39 is pushed into the receiving portion 35, the first engaging element 53 is locked in the mating groove 59, while the second engaging element 55 is outside the second mating groove 63. Therefore, the proximal resistance F of the first interface 45... A→E The proximal resistance F of the second interface 47 is greater than that of the second interface 47. L→E This resistance is caused solely by the sliding friction between the protective sleeve 39 and the receiving portion 35. Therefore, at the distal end, only the portion of the insertion force F corresponding to the sliding friction between the protective sleeve 39 and the receiving portion 35 is present. AThe force acts on the locked first engaging element 53. However, this force component is insufficient to radially outward compress the first engaging element 53 to disengage the mating groove 59 distally. The proximal radial penetration depth t1 of the first engaging element 53 in the first mating groove 59 is accordingly selected such that a certain minimum distal force must be applied by the insertion portion 1 to the first engaging element 53 to radially outward compress it to the extent that the mating groove 59 disengages distally. Below this minimum force, the insertion portion 1 is distally secured in the protective sleeve 39 in the first axial position. The protective sleeve 39 is irrevocably secured distally to the insertion portion 1 by means of a convex, flange, or thickened stop 65 on the inner side of the protective sleeve 39. Alternatively or additionally, the mating groove 59 is asymmetrically configured such that the mating groove 59 can only disengage distally from the first engaging element 53 and not proximally.

[0073] Resistance F at the first interface 45 A→E The resistance F of the first interface 45 depends not only on the proximal radial penetration depth t1 of the first engaging element 53 in the first mating groove 59, but also on the geometry of the first engaging element 53 and the geometry of the first mating groove 59. Here, the engaging elements 53 and 55 are constructed as O-rings, and the cross-sectional geometry of the mating grooves 59 and 63 is arc-shaped, having corresponding diameters to precisely accommodate the respective O-rings 53 and 55. A→E It also depends on Figure 19 The slope angle ε shown can be between 0° and 90°, where the resistance F A→ It is maximum at 90° and minimum at 0°. The ramp angle ε is accordingly selected such that a certain minimum distal force must be applied by the insertion part 1 to the first engaging element 53 to radially outward press the first engaging element to the extent that the mating groove 59 is loosened toward the distal end.

[0074] exist Figure 20 In the middle, the protective sleeve 39 is pushed toward the distal end into the receiving portion 35 to the extent that the second engaging element 55 is just stopped on the positioning element 33. The first interface 45 having the first engaging element 53 and Figure 19 There is no change compared to the previous version. The proximal end of the receiving portion 35 widens towards the proximal end, thereby forming a tapered ramp 67. This, in conjunction with the outer diameter of the protective sleeve 39, which gradually tapers at its distal end, not only makes it easier for the protective sleeve 39 to be inserted into the receiving portion 35, but the ramp 67 also serves to radially inwardly press the second engaging element 55. Therefore, the proximal resistance F of the second interface 47... L→E Maintaining a proximal resistance F below the first interface 45 in a defined manner A→E .

[0075] The proximal end 69 of the second mating groove 63, which is also the distal end of the ramp 67, determines the radial penetration depth t2 on the proximal side. This penetration depth must be radially inwardly compressed before the second engaging element 55 can be extended outward again into the mating groove 63, i.e., locked there. When the O-rings 53 and 55 have the same cross-section and are made of the same material, the value t2 can be equal to the value t1 of the first interface 45. However, to prevent the first interface 45 from being released when the second engaging element 55 is compressed, i.e., the first engaging element 53 is pressed, the ramp angle α of the ramp 67 is chosen to be flatter than the ramp angle ε of the first interface 45, i.e., α < ε. This ensures that the resistance F of the first interface 45... A→E The resistance F at the second interface 47 was always greater than the resistance at the second interface. L→E Until the protective sleeve 39 reaches the maximum distal position, i.e. the target position, in the receiving portion 35, and the second engaging element 55 is locked in the second mating groove 63.

[0076] Figure 21 The two interfaces 45 and 47 are shown in a locked state. The protective sleeve 39 is located in a first axial position relative to the insertion portion 1, and at the maximum distal position, i.e., the target position, in the receiving portion 35, because the first interface 45 is locked in the first mating groove 59 by means of the first engaging element 53, and the second interface 47 is locked in the second mating groove 63 by means of the second engaging element 55. The mating grooves 59 and 63 are respectively constructed asymmetrically, such that when moving away from the locked position in the distal and proximal directions, the corresponding resistance F A→E or F L→E They are different from each other.

[0077] The second interface 47 can form a stop, for example, by extending the distal end 71 of the second mating groove 63 radially inward until the second engaging element 55 achieves a distal radial penetration depth t3 in the second mating groove 63, where t3 > t2. Here, the second engaging element 55 can be configured such that it cannot actually be compressed to a penetration depth t3, or this is only possible under inappropriately high forces. Furthermore, the second mating groove 63 defines a relatively steep distal ramp angle γ, where γ > ε. Therefore, the second engaging element 55 forms a distal stop in the second mating groove 63, which determines the maximum distal position, i.e., the target position, of the protective sleeve 39 in the receiving portion 35.

[0078] The first interface 45 is similarly constructed in reverse as an asymmetry. The proximal radial penetration depth t1 of the first engaging element 53 in the first mating groove 59 is determined by the proximal end 73 of the first mating groove 59. The distal radial penetration depth t4 of the first engaging element 53 in the first mating groove 59 is determined by the distal end 75 of the first mating groove 59, where t4 > t1. The values ​​t1, t2, t3, and t4 can be chosen to satisfy t4 = t3 > t2 = t1. Here, the first engaging element 53 can be constructed such that it cannot actually be compressed to a penetration depth t4, or this is only possible under inappropriately high forces. Furthermore, the first mating groove 59 defines a relatively steep distal ramp angle η, where η > ε. Thus, the first engaging element 53 forms a proximal stop in the first mating groove 59, which makes the protective sleeve 39 irrevocably secured to the insertion portion 1. Furthermore, the insertion portion 1 forms a ramp 68 on the outer side, similar to the ramp 67 of the second interface 47. The ramp surface 68 extends from the first mating groove 59 toward the proximal end, such that the insertion portion 1 gradually tapers toward the proximal end at a certain distance with a ramp angle δ (which may be equal to the ramp angle α) by approximately a value t1. The ramp angle δ is chosen to be flat, such that when the needle tip 9 is pulled back into the protective sleeve 39, the resistance F of the first interface 45 is... A→E The resistance is less than that of the locked second interface 47, and thus the first interface 45 is locked before the second interface 47 is unlocked and the protective sleeve 39 moves toward the proximal end away from the target position.

[0079] Figure 22 It shows when in Figure 21 The locking position shown applies a distal insertion force F to the handle element 23. A The resistance F generated at that time A→E and F L→E The proximal resistance F of the second interface 47 L→E The near-end resistance F is now 45 above the first interface. A→E (Because t3>t1, γ>ε). Thus, the first mating groove 59 presses against the locked first engaging element 53 with a proximal slope surface of an angle of ε, such that the proximal end 73 of the first mating groove 59 is squeezed toward the distal end of the first engaging element 53 under the elastic deformation of the first engaging element 53.

[0080] exist Figure 23 In the event of elastic deformation of the first engaging element 53, the proximal end 73 of the first mating groove 59 is pressed toward the distal end, thereby overcoming the initial large resistance F of the first interface 45. A→EThe protective sleeve 39 remains in its maximum distal position relative to the receiving portion 35, but has moved away from its first axial position relative to the insert portion 1 by further pressing the insert portion 1 toward the distal end. Now, only a relatively small sliding frictional force forms the resistance F of the first interface 45. A→E Therefore, the insertion part 1 can be inserted into the body 5 relatively easily.

[0081] exist Figure 24 In the middle, through the proximal pull-out force F A Remove the insertion part 1 from the body 5. (Example) Figure 23 As shown, the resistance F forming the first interface 45 A→E The sliding friction is less than the resistance F of the second interface 47. L→E The resistance F at the second interface 47 L→E The penetration depth t2 of the second engagement element 55 in the second mating groove 63 is determined on one hand by the proximal side penetration depth t2, and on the other hand by the proximal side ramp angle β of the second mating groove 63. The ramp angle β of the second interface 47 can correspond to the ramp angle ε of the first interface 47. Therefore, the protective sleeve 39 is retained in the receiving portion 35 at the maximum distal position, i.e., the target position, in which the needle tip 9 is pulled into the protective sleeve 39 with the proximal end facing inward.

[0082] exist Figure 25 The first interface 45 is locked again, causing the protective sleeve 39 to be positioned in a first axial position relative to the insertion part 1, where the protective sleeve 39 protectively surrounds the needle tip 9. Due to the relatively high penetration depth t4 and the relatively steep ramp angle η, which together form a proximal stop effectively against the insertion part 1, the distal resistance F of the first interface 45 is now reduced. A→E The far-side resistance F of the second interface 47 is greater than that of the second interface 47. L→E (Because t4>t2 and η>β). Thus, the second mating groove 63 with a proximal side ramp angle β presses against the second engaging element 55, thereby causing the second engaging element to be pressed towards the proximal end 69 of the second mating groove 63 until the second interface 47 is unlocked and the protective sleeve 39 moves away from the target position towards the proximal end.

[0083] exist Figure 26 In the middle, the second interface 47 is fully unlocked, and the protective sleeve 39 is pulled out from the receiving portion 35 toward the proximal end by the locking first interface 45 in the first axial position. Here, the resistance F of the second interface 47 is only caused by sliding friction. L→E The resistance F is significantly less than that of the first interface at 45. A→E The relatively high penetration depth t4 and relatively steep slope angle η of the first mating groove 59 together form a distal stop that is actually aimed at the protective sleeve 39.

[0084] Figure 27An alternative embodiment is shown in which engaging elements 53, 55 are integral components of the protective sleeve 39. In other embodiments, it is also conceivable that the first engaging element 53 is integrally formed of the insertion portion 1, and / or the second engaging element 55 is integrally formed of the positioning element 33. Here, the first engaging element 53 of the first interface 45 is formed by at least one spring tongue disposed on the inner side of the protective sleeve 39, which can engage or lock in a corresponding recess 59 on the outer side of the insertion portion 1. Preferably, the first engaging element 53 is formed by two or more spring tongues evenly distributed along the circumferential side. At least one spring tongue 53 is hinged on the proximal side and forms a relatively flat proximal side ramp angle, such that the protective sleeve 39 can move away from the first axial position relative to the insertion portion 1 toward the proximal end, and the spring tongue 53 is radially outwardly flexed in this position. When the protective sleeve 39 is pushed toward the distal end into the first axial position shown, the spring tongue 53 forms a stop on the distal side, which abuts against the steep distal side surface of the recess 59. Thus, the protective sleeve 39 is irrevocably fixed to the insertion part 1.

[0085] The second engaging element 55 may be formed, similar to the first engaging element 53, by one or more outwardly pointing spring tongues. However, according to... Figure 27 In one embodiment, the second engaging element 55 is formed by a radial protrusion that extends outward from the outside of the protective sleeve 39 and engages in the second recess 63, which here corresponds to the embodiment according to Figures 19 to 26 The second mating groove 63 of the illustrated embodiment. Here, the protective sleeve 39 is slotted for a length s in the proximal end region, forming a protective sleeve end section 77, which has a radial distance a relative to the insertion portion 1 and can therefore be elastically bent inward. Thus, when the second interface 47 is locked and unlocked, the engaging element 55 arranged at the protective sleeve end section 77 can be elastically pressed inward. Here, the radial distance a is selected to be greater than or equal to the proximal penetration depth t2 of the second engaging element 55 in the second recess 63, but less than the distal penetration depth t3 of the second engaging element 55 in the second recess 63, i.e., t3>a>t2. The engaging elements 53, 55 themselves can be elastically deformable, but are not required. The engaging elements 53, 55 can here be designed to be merely movable.

[0086] The designations of components or directions of motion, such as "first," "second," and "third," are arbitrarily chosen purely to distinguish them, and any other choices are permissible. They are unrelated to any order of importance. The designation of a component or technical feature as "first" should not be misinterpreted as implying a mandatory second such component or technical feature. Furthermore, unless explicitly stated otherwise or absolutely necessary, any method steps may be performed in any order and / or at any time, partially or completely overlapping.

[0087] Equivalent embodiments of the parameters, components, or functions described herein, which are obvious to those skilled in the art based on this disclosure, are also included in this invention as expressly described herein. Accordingly, the scope of the claims should include these equivalent embodiments. Features considered optional, advantageous, preferred, desired, or similarly expressed "may" be understood as optional and not as a limitation on the scope of protection.

[0088] The embodiments described herein should be understood as illustrative examples and do not represent an exclusive list of possible embodiments. Each feature disclosed within one implementation framework, regardless of which embodiment it is correspondingly described in, can be used alone or in combination with one or more other features. Although at least one embodiment has been described and shown herein, variations and alternative embodiments that will be apparent to those skilled in the art in light of this specification are also included within the scope of this disclosure. Furthermore, the term "having" should not exclude other additional features or method steps, and "a" does not exclude multiple.

[0089] List of reference numerals

[0090] 1. Insertion section

[0091] 3. Tissue to be examined / treated

[0092] 5. Organic organisms

[0093] 5a Skin of an organic organism

[0094] 7. Active light-emitting element / LED

[0095] 7a LED end side

[0096] 9 needle tips

[0097] 9a The sleeve-shaped part of the needle tip

[0098] 11 Conductor elements

[0099] 13 Connection Points

[0100] 15 Lateral force F L,S

[0101] 17. External body acting laterally

[0102] 19 Separation force

[0103] 21 Light Illuminators

[0104] 23 Handle components

[0105] 25 Connecting cable

[0106] 27. Operator's hands

[0107] 29 Lateral force F L,H

[0108] 31. Light Illumination System

[0109] 33 Positioning elements

[0110] 35. Reception area

[0111] 37. Fixing elements

[0112] 39 Protective Case

[0113] 43 LED light

[0114] 45 First Interface

[0115] 47 Second Interface

[0116] 49 joints

[0117] 51 Treatment Table

[0118] 53 First Connecting Element

[0119] 55 Second coupling element

[0120] 57 First Groove

[0121] 59 First Pairing Groove / Recess

[0122] 61 Second Groove

[0123] 63 Second Pairing Groove / Recess

[0124] 65 Stop component

[0125] 67, 68 Slope surface

[0126] 69 Proximal end of the second mating groove / recess

[0127] 71 The distal end of the second mating groove / recess

[0128] 73 Proximal end of the first mating groove / recess

[0129] 75 The distal end of the first mating groove / recess

[0130] 77 Protective sleeve end section

[0131] d1 is the length of the insertion part without the needle tip.

[0132] d2 is the length of the needle tip.

[0133] Z N longitudinal axis of the insertion part

[0134] Z Expected insertion direction

[0135] F A Manual insertion or withdrawal force

[0136] L Axial length of the receiving part

[0137] t1 Proximal side penetration depth of the first bonding element

[0138] t2 Proximal side penetration depth of the second bonding element

[0139] t3 Distal side penetration depth of the second bonding element

[0140] t4 Distal side penetration depth of the first bonding element

[0141] a radial distance

[0142] s Length of the end section of the protective sleeve

[0143] α, β, γ, ε, η, δ slope angle

[0144] F A→E Resistance at the first interface

[0145] F L→E Resistance at the second interface.

Claims

1. A light irradiation system (31) for examination and / or treatment of an organic organism (5), wherein the light irradiation system (31) has at least one light irradiator (21) and a positioning element (33). The light irradiator (21) has a distal insertion portion (1) at its distal end, the insertion portion having at least one active light-emitting element (7) for inserting into the tissue (3) of the organic organism (5), wherein the insertion portion (1) has a needle tip (9) arranged at least partially away from the at least one active light-emitting element (7) and gradually tapering toward the distal end. The positioning element (33) is capable of being fixed at least temporarily in a defined position and orientation relative to the organism (5), and has at least one receiving portion (35) for the at least one light irradiator (21), the at least one light irradiator (21) having at least temporarily in the receiving portion a defined orientation relative to the organism (5). The light irradiator (21) has a protective sleeve (39) that is axially movable relative to the insertion part (1), the protective sleeve protectively surrounds the needle tip (9) in a first axial position relative to the insertion part (1), and is pushed back proximally from the needle tip (9) in a second axial position relative to the insertion part, determined according to the axial position of the insertion part (1) relative to the positioning element (33). The protective sleeve (39) is used as an insertion sleeve in at least one receiving portion (35) of the positioning element (33). The light irradiation system (31) also has an elastically deformable and / or movable engagement element (53), wherein the engagement element (53) is arranged between the insertion portion (1) and the protective sleeve (39) such that the engagement element elastically buckles or moves to a degree that allows the protective sleeve (39) to reach the first axial position distally and / or move away from the first axial position proximally in the face of an axial force. The engagement element (53) is the first engagement element among at least two elastically deformable and / or movable engagement elements (53, 55) including a second engagement element (55), and the axial force is the first axial force among at least two axial forces including a second axial force, wherein the second engagement element (55) is arranged between the protective sleeve (39) and at least one receiving portion (35) of the positioning element (33) such that the second engagement element elastically buckles or moves to a degree that enables the protective sleeve (39) to reach a target position in the positioning element (33) distally and / or proximally in the event of the second axial force.

2. The light irradiation system (31) according to claim 1, wherein, The protective sleeve (39) has at least a partial outer diameter that precisely matches the inner diameter of at least one receiving portion (35) of the positioning element (33).

3. The light irradiation system (31) according to claim 2, wherein, The outer diameter of the protective sleeve (39) gradually tapers toward the distal end, and / or the inner diameter of at least one receiving portion (35) of the positioning element (33) widens toward the proximal end.

4. The light irradiation system (31) according to claim 1, wherein, The insertion part (1) of the light irradiator (21) is rigid, and in the axial direction (Z) N It has a longer length than the protective sleeve (39).

5. The light irradiation system (31) according to claim 1, wherein, The protective sleeve (39) is securely fixed to the insertion part (1) of the light irradiator (21) without loss.

6. The light irradiation system (31) according to claim 1, wherein, The light irradiator (21) has a handle element (23) on the proximal side for manually positioning the light irradiator (21).

7. The light irradiation system (31) according to claim 6, wherein, The axial position of the insertion part (1) relative to the positioning element (33) can be determined by the axial direction (Z). N The handle element (23) is positioned on the handle and is manually adjusted.

8. The light irradiation system (31) according to any one of claims 1 to 7, wherein, When the light irradiator (21) is inserted into at least one of the receiving portions (35) of the positioning element (33) at the distal end, the protective sleeve (39) is fixed in the first axial position for a long time until the protective sleeve (39) reaches the target position in the positioning element (33) at at least one receiving portion (35) of the positioning element (33), at which the insertion portion (1) can be pushed out of the protective sleeve (39) toward the distal end.

9. The light irradiation system (31) according to claim 8, wherein, When the light irradiator (21) is pulled out from at least one of the receiving portions (35) of the positioning element (33) from the proximal end, the protective sleeve (39) remains fixed in the positioning element (33) at the target position for an extended period of time until the protective sleeve (39) occupies a first axial position relative to the insertion portion (1), in which the protective sleeve (39) can be pulled out from at least one of the receiving portions (35) of the positioning element (33) towards the proximal end.

10. The light irradiation system (31) according to any one of claims 1 to 7, wherein, The first engaging element (53) is part of the protective sleeve (39) and / or the insertion part (1).

11. The light irradiation system (31) according to any one of claims 1 to 7, wherein, The second engagement element (55) is part of the protective sleeve (39) and / or the positioning element (33).

12. The light irradiation system (31) according to any one of claims 1 to 7, wherein, When moving toward the far end, the first axial force is greater than the second axial force, and when moving toward the near end, the second axial force is greater than the first axial force.

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