LIGHT APPLICATOR SYSTEM WITH PRE-PITCHING AID

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] For example, US 6,048,359 describes how several light applicators are inserted into pathological tissue using a positioning grid.

[0006] However, a technical challenge with existing solutions has emerged: piercing the skin with a very thin and long light applicator sometimes requires such high manual force that the applicator bends, causing the deeper target tissue to be missed. This problem is particularly acute when the target tissue is located relatively deep within the body, meaning the light applicator must be relatively long but as thin as possible to minimize the invasiveness of the insertion.

[0007] This leads to the task of providing a light applicator system that allows deep tissue in an organic body to be reached for examination and / or treatment in the most targeted and minimally invasive way possible.

[0008] According to the present disclosure, a light applicator system according to claim 1 is provided for the examination and / or treatment of an organic body to solve this problem. This ensures that the needle tip of the light applicator automatically finds the small opening pre-made in the patient's skin by the needle tip of the pre-piercing aid, simply by inserting the light applicator into the at least one receptacle of the positioning element and moving it distally forward within this receptacle. The operator therefore does not need to search for the small pre-pierced skin opening and requires no manual dexterity to locate it. The pre-piercing reduces the resistance caused by the tough skin that the applicator encounters when being inserted or advanced into or through the skin, thereby reducing the risk of bending the light applicator.its insertion section is reduced so that the needle tip of the light applicator reaches the target point in the organic body.

[0009] The light applicator disclosed herein preferably does not use a laser light guide, but rather generates the diagnostic or therapeutic light in situ at the distal end of the applicator using an active light-emitting element, e.g., a miniaturized LED, for example, with a lateral width of less than 1 mm. An "active" light-emitting element is understood here to mean only a light-emitting element that absorbs electrical energy and converts it into light, i.e., not a light guide that merely transmits and / or couples out light. An expensive laser is not required with an active light-emitting element, thus significantly reducing costs. The light applicator disclosed herein can be manufactured very inexpensively and can therefore be implemented as a sterile, single-use, disposable 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, and because the applied light doses are comparatively low, healthy tissue is not damaged by the light. This eliminates the need for precise localization of the pathological tissue beforehand and reduces the risk of pathological tissue going undetected and untreated.

[0010] Preferably, the insertion section of the light applicator has a needle tip that is positioned at least partially distal to the LED and tapers distally to a point, incorporating a light-transparent diffusing element for scattering the LED light. The needle tip of the insertion section of the light applicator serves, on the one hand, to make the insertion as minimally invasive as possible, and on the other hand, to scatter the LED light as isotropically and / or homogeneously as possible over the largest possible solid angle, e.g., over 3π.

[0011] 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 placed and / or adhered to the patient's skin, either close to or directly on the skin, in order to show the user the insertion points, angles and / or depths for the light applicators and to achieve the most complete and largely homogeneous illumination of the organ possible.

[0012] 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.

[0013] The pre-piercing aid allows the skin to be pre-pierced before the actual insertion of the light applicator, significantly reducing the resistance the skin encounters during insertion. Preferably, the pre-piercing aid not only pre-pierces the skin but also widens and / or incises it, reducing not only the initial resistance to the insertion of the light applicator but also the subsequent frictional resistance on the light applicator as it passes through the skin. Preferably, however, the pre-piercing aid or its needle tip is designed so that the pre-piercing is as atraumatic and minimally invasive as possible, resulting in a very small opening in the skin after the pre-piercing aid is withdrawn. This facilitates the subsequent location and precise targeting of the opening with the light applicator.whose needle tip, while posing a significant challenge on the one hand, is often sufficient to reduce the resistance generated by the skin when inserting the light applicator.

[0014] According to the invention, the light applicator system further comprises a stop that defines a maximum pricking depth of the pricking aid. This has the advantage that the pricking aid is not accidentally inserted too deeply.

[0015] In an embodiment of the light applicator system not claimed here, the pre-piercing aid can preferably be a component separate from the light applicator, which can be removed from the at least one receptacle of the positioning element after a pre-piercing into the organic body, in order to subsequently insert the light applicator into the pre-pierced organic body through the at least one receptacle of the positioning element for examination and / or treatment of the organic body.

[0016] The pre-punching aid can be designed to be more rigid than the light applicator, since the pre-punching aid can be designed to be shorter and / or thicker than the light applicator.

[0017] Optionally, the pre-piercing aid can have a pre-piercing aid shaft with an axial length and diameter that define a first length-to-diameter ratio, and the insertion section of the light applicator can have an axial length and diameter that define a second length-to-diameter ratio, the second being significantly larger than the first. This allows the pre-piercing aid to be designed with considerably greater flexural rigidity than the insertion section of the light applicator. Additionally, the flexural rigidity of the pre-piercing aid can be optimized with regard to material selection, e.g., by using a solid, hard steel core, which may not always be possible for the light applicator due to other additional requirements (e.g., a soft copper core for good heat conduction from the distal active light-emitting element to the proximal side).

[0018] Optionally, the needle tip of the pre-piercing aid can have at least one or more cutting edges, which incises the pre-pierced skin, reducing skin tension and thus the resistance caused by the skin when piercing the insertion section of the light applicator.

[0019] Optionally, at least one of these cutting edges can be designed as a distally projecting cutting blade, which can simplify the incision of the skin and / or produce an even cleaner cut.

[0020] Regardless of the design with regard to optional cutting edges or blades, the needle tip of the pre-piercing aid, or its tip, is always axially centered in relation to the pre-piercing aid shaft. Likewise, the needle tip of the light applicator, or its tip, is always axially centered in relation to the insertion section of the light applicator.

[0021] Optionally, the pre-puncture aid can have a pre-puncture aid shaft with a diameter identical to the diameter of the insertion section of the light applicator, and both fit precisely into an inner diameter of the at least one receptacle of the positioning element. The greater flexural rigidity of the pre-puncture aid shaft required compared to the insertion section of the light applicator is achieved by making the pre-puncture aid shaft shorter. Preferably, the needle tip of the pre-puncture aid is provided with at least one cutting edge or blade. This at least one edge or blade allows the skin to be incised during the pre-puncture, thus reducing resistance when the light applicator is inserted.

[0022] Optionally, the pre-puncture aid can have a pre-puncture aid shaft with a diameter that fits precisely into an inner diameter of at least one receptacle of the positioning element and is larger than the diameter of the insertion section of the light applicator. The light applicator system further comprises an adapter sleeve whose inner diameter precisely matches the diameter of the insertion section of the light applicator and which, at least in sections, has an outer diameter that fits precisely into an inner diameter of at least one receptacle of the positioning element. The thicker pre-puncture aid shaft allows the skin to be stretched during pre-puncture, thus reducing resistance when the light applicator is inserted. Optionally, the adapter sleeve can also serve as a protective sleeve for the needle tip of the insertion section of the light applicator and can be axially movable and captive when coupled to the insertion section.

[0023] Optionally, the pre-punching aid can be designed to be inserted into the receptacle of the positioning element in conjunction with an adapter sleeve, which acts as a protective sleeve for the needle tip of the pre-punching aid. The inner diameter of the adapter sleeve must precisely match the diameter of the insertion section of the pre-punching aid, and at least in part, the adapter sleeve must have an outer diameter that precisely fits into the inner diameter of at least one receptacle of the positioning element. If the needle tip of the pre-punching aid is, for example, designed with sharp cutting edges or even a cutting blade, the skin can be incised during the pre-punch to reduce resistance when the light applicator is inserted.

[0024] Optionally, both the light applicator and the stitching aid can be designed so that they are inserted into the receptacle of the positioning element in conjunction with an adapter sleeve that acts as a protective sleeve for the respective needle tip, whereby the adapter sleeve of the light applicator is identical to the adapter sleeve of the stitching aid at least with regard to outer and inner diameter, but possibly even completely identical.

[0025] According to the invention, the pre-piercing aid is integrated into the light applicator, wherein the needle tip of the pre-piercing aid is a needle tip of the light applicator that is arranged at least partially distal to the LED and tapers distally to a point, and includes a light-transparent diffuser for scattering the light from the LED. The stop is positionable and / or malleable such that, in a stop position, it defines a maximum pre-piercing depth of the light applicator, and in a non-stop position, it allows a greater penetration depth. Thus, the needle tip of the light applicator forms the needle tip of the pre-piercing aid, and the insertion section of the light applicator forms the shaft of the pre-piercing aid. Preferably, the stop of the pre-piercing aid is formed by a stabilizing sleeve that can be positioned and fixed axially on the insertion section of the light applicator.

[0026] The insertion aid can optionally include a stabilizing sleeve, which preferably forms the stop and is axially movable on the insertion aid shaft and can be fixed in a selectable axial position. This allows the insertion depth to be adjusted to the application. The stabilizing sleeve can also function as an adapter sleeve and / or protective sleeve for the needle tip of the insertion section of the light applicator or be designed as a separate component. The stabilizing sleeve can stabilize the thin insertion section of the light applicator proximal to the positioning element, thus making it more rigid for insertion through the skin.

[0027] Optionally, the insertion aid and / or the light applicator can have a handle element on its proximal side for manual positioning and alignment. Preferably, there is only one handle element. However, in the embodiment with a separate insertion aid, there can also be only one handle element if it can be repositioned to fit both a proximal end of the insertion section and a proximal end of the insertion aid. Alternatively, the insertion aid and the light applicator can each have their own handle element. Optionally, the axial position of the insertion aid and / or the insertion section relative to the positioning element can be manually adjusted by positioning the handle element in the axial direction.

[0028] Optionally, the handle element can form the stop and be axially movable on the pre-stitching aid and / or the insertion section, and fixed in a selectable axial position. The handle element can then be pushed distally through the skin for the pre-stitching until it encounters the positioning element. The pre-stitching aid can then be designed to be very short and correspondingly rigid.

[0029] Optionally, the light applicator system can include a resistance component that exerts a proximal resistance force against a distally applied manual force on the pre-piercing aid up to a maximum resistance force, and abruptly releases the pre-piercing aid distally as soon as the distally applied manual force on the pre-piercing aid exceeds the maximum resistance force. This is particularly advantageous when the skin yields relatively far distally and the proximal reaction force applied by the skin remains relatively small for a long time, so that the skin is only indented, but the pressure of the needle tip of the pre-piercing aid is insufficient for a puncture.In this case, if the pre-puncture device has not yet engaged, the skin can stretch over a relatively large distal distance with a slowly increasing reaction force and then, when the pressure of the pre-puncture device's needle tip is reached to perform a pre-puncture, snap back abruptly proximally. The needle tip of the pre-puncture device could then already be too far through the skin into underlying tissue, which should be avoided to make the pre-puncture as minimally invasive as possible. This problem is exacerbated by the fact that the positioning element, for example, in the form of a puncture template adhered to the skin, can obstruct the operator's view of the needle tip and the skin.

[0030] To solve this problem, the resistance component of the skin takes over the function of building up a reaction force to generate the necessary pressure on the skin for the pre-puncture. As soon as the operator has increased the manual distal force to such an extent that the maximum resistance force is exceeded, the pre-puncture aid experiences a sudden distal force impulse with corresponding acceleration to apply the necessary pressure to the skin for the pre-puncture. Preferably, the needle tip of the pre-puncture aid strikes and penetrates the skin at a speed that prevents it from yielding too quickly due to its inertia and in conjunction with the underlying tissue. The impact then stops the pre-puncture aid to prevent the pre-puncture from being too deep.

[0031] Optionally, the resistance component can be at least partially elastically deformable and tensioned by the distal manual force.

[0032] Optionally, the resistance component can have at least one substantially axially extending strut with foot, wherein the foot, under tension of the strut, pushes the distally directed manual force radially away and snaps back upon exceeding the maximum resistance force with sudden relaxation of the strut.

[0033] 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.

[0034] The disclosure is explained in more detail below with reference to exemplary embodiments shown in the drawings. These show: Fig. 1 a schematic longitudinal section view of the insertion of an embodiment of the light applicator disclosed herein into the skin of a patient with a positioning element placed on the skin; Figs. 2 bis 4 Schematic longitudinal section views of an embodiment of the light applicator system disclosed herein at various stages of pre-piercing the skin using a pre-piercing aid disclosed herein; Figs. 5a-c Schematic longitudinal section views of various embodiments of the needle tip of the pre-stitching aid disclosed herein; Figs. 6 , 6a , 7 bis 11 Schematic longitudinal sectional views of various embodiments of the light applicator system disclosed herein; Figs. 12 bis 14 Schematic longitudinal sectional views of an embodiment of the light applicator system disclosed herein at various stages of pre-punching the skin to illustrate the problem with very pliable patient skin; and Fig. 15 bis 18 Schematic longitudinal section views of an embodiment of the light applicator system disclosed herein at various stages of pre-punching the skin to illustrate the solution to the problem in cases of very compliant patient skin.

[0035] Fig. 1 illustrates the problem solved by the light applicator system disclosed herein. Fig. 1 Figure 1 shows a light applicator 1 being inserted into the skin 7 of an organic body 9 through a receptacle 3 of a positioning element 5. The positioning element 5 is, for example, a insertion template that is positioned and adhered to the skin 7 in such a way that a precise target point 10 in the target tissue 11 of the organic body 9 is reached by the light applicator 1 when the receptacle 3, which is designed as an opening or hole in the insertion template, is inserted. The target tissue 11 can be, for example, a tumor in an organ or the entire organ, such as the prostate. As shown here, the positioning element 5 can have several receptacles 3 to offer multiple insertion points and / or to allow the simultaneous use of several light applicators 1.

[0036] A distal end of an insertion section 13 of the light applicator 1 is to be inserted into the target tissue 11 for photodynamic therapy (PDT) or diagnosis (PDD) in order to irradiate this target tissue 11 with light. The distal end of the insertion section 13 has an active light-emitting element in the form of an LED (not shown here), the main emission direction of which is directed longitudinally along the insertion section 13. At least partially distal to the LED is a needle tip 25 that tapers distally to a point and incorporates a light-transparent diffuser for scattering the light from the LED. The needle tip 25 is essentially formed in one piece from the light-transparent diffuser, which may, for example, be made of plastic with reinforcing elements.

[0037] The insertion section 13 of the light applicator 1 is designed to be as thin as possible (with a diameter of 1 mm or less) and rigid for minimally invasive treatment or diagnosis. However, to reach target tissue 11 located relatively deep within the organic body 9, the insertion section 13 of the light applicator 1 must be relatively long. This limits the achievable bending stiffness of the insertion section 13 of the light applicator 1. Even when using a very rigid, tubular shaft material arranged externally, such as steel, the insertion section 13 of the light applicator 1 can be manually bent when inserted into the skin 7.

[0038] This problem is in Fig. 1 The skin 7 can be very leathery and tough, so that even with a very sharp needle tip 25, the manual force FA required by the operator to push a handle element 27 of the light applicator 1 distally, located proximally on the insertion section 13 of the light applicator 1, is relatively large. The insertion section 13 of the light applicator 1 can bend as shown. However, such bending is problematic even if it is relatively small, because the needle tip 25 can then miss the target point 10 in the deep target tissue 11. Since the penetration depth of the light into the tissue is not very deep, depending on the wavelength used, and thus only a relatively small tissue volume can be irradiated, several light applicators 1 may need to be positioned precisely at a respective target point 10 in the target tissue 11 in order to cover the entire volume of the target tissue 11 by the sum of the irradiated tissue volumes. With a method as shown in Fig. 1 Due to the bending of the insertion section 13 of the light applicator 1 shown, precise positioning at the target point 10 in the target tissue 11 cannot be guaranteed.

[0039] Figuren 2 bis 4 We show a light applicator system 19 that solves this problem without making the insertion section 13 of the light applicator 1 thicker and thus less minimally invasive. The light applicator system 19 includes a pre-piercing aid 21, which in the illustrated embodiment is a separate component from the light applicator 1. Before the light applicator 1, with its needle tip 25 arranged axially centrally with respect to the insertion section 13, is inserted into the skin 7 through the receptacle 3 of the positioning element 5, the skin 7 is first pre-pierced by means of the pre-piercing aid 21 to reduce skin resistance.The pre-punching aid 21 is essentially designed in the form of a needle with a metallic pre-punching aid shaft 23, a needle tip 15 arranged axially centrally at the distal end of the pre-punching aid shaft 23 and with respect to this pre-punching aid shaft 23, and a handle element 17 arranged at the proximal end of the pre-punching aid shaft 23, wherein the pre-punching aid shaft 23 has a significantly smaller length-diameter ratio than the insertion section 13 of the light applicator 1, i.e. L1 / D1 «L2 / D2, and thus significantly more rigid. Preferably, the pre-puncture aid shaft 23 has a length L1 significantly shorter than the length L2 of the insertion section 13 of the light applicator 1 and / or a thickness D1 significantly thicker than the thickness D2 of the insertion section 13 of the light applicator 1. The inner diameter of the receptacle 3 of the positioning element 5 corresponds precisely to the outer diameter D1 of the pre-puncture aid shaft 23. The highly rigid pre-puncture aid 21 is axially guided by the receptacle 3 of the positioning element 5, and the needle tip 15 of the pre-puncture aid 21 is also axially centered, so that the position 8 of the pre-puncture, i.e., the position of the opening 8 in the skin 7 created by the needle tip 15, which is later to be located by the needle tip 25 of the light applicator 1 by advancing it within the receptacle 3, is very precisely defined. The pre-stitching aid 21 can optionally be designed such that it is used in the Fig. 3 In the axial position shown, in which the pre-stitching aid 21 has maximally stretched the skin 7, it encounters a stop (not shown here). This protects the tissue 26 located under the skin 7 from an unnecessarily deep pre-stitch with the relatively thick pre-stitching aid 21. Fig. 4 The figure shows how, after the pre-puncture, the pre-puncture aid 21 is withdrawn proximally from the receptacle 3 of the positioning element 5, leaving only a small opening in the skin 7 at the precisely defined position 8, due to the required minimal invasiveness. This opening is nevertheless precisely targeted by the needle tip 25 of the light applicator 1 when it is later inserted into the organic body 9. It is important that the positioning element 5 remains firmly positioned relative to the skin 7, for example, by remaining adhered.

[0040] In Figuren 5a-c Various embodiments of the needle tip 15 of the stitching aid 21 are shown. Fig. 5a In its simplest form, the needle tip 15 is conical, so that the skin 7 is widened as it penetrates distally. To reduce the resistance resulting from the stretching of the skin 7, the needle tip 15 has a Fig. 5b A cutting blade 28 projects distally and forms a cutting edge 29, which incises the skin 7. This reduces skin tension, thus decreasing the resistance of the skin 7. Fig. 5c It has been shown that there can be several cutting edges 29, which do not necessarily have to project distally. The needle tip 23 is in Fig. 5c pyramid-shaped, with the pyramid edges forming the (here three) cutting edges 29.

[0041] Fig. 6 Figure 1 shows how the light applicator 1 can be used after pre-punching with the pre-punching aid 21, which has now been removed from the positioning element 5. Since the insertion section 13 of the light applicator 1 is significantly thinner than the pre-punching aid 21, an adapter sleeve 31 is provided. This adapter sleeve compensates for the difference between the thickness D1 of the pre-punching aid shaft 23 and the thickness D2 of the insertion section 13 of the light applicator 1, so that the inner diameter of the adapter sleeve 31 corresponds exactly to the outer diameter D2 of the insertion section 13 of the light applicator 1. Furthermore, the adapter sleeve 31 has, at least in sections, an outer diameter D1 that fits precisely into a corresponding inner diameter of the receptacle 3 of the positioning element 5.

[0042] The adapter sleeve 31 can serve as a protective sleeve for the sensitive needle tip 25 of the light applicator 1 and can be pre-installed on the insertion section 13 of the light applicator 1 in a captive and axially movable manner. Alternatively, the adapter sleeve 31 can first be manually inserted into the receptacle 3 and then the insertion section 13 of the light applicator 1 inserted, or the adapter sleeve 31 can first be placed onto the insertion section 13 of the light applicator 1 and then inserted into the receptacle 3 together with it. The adapter sleeve 31 can also serve as a stabilizing sleeve for the insertion section 13 of the light applicator 1 in order to provide, at least in part, a stability as described in Fig. 1 to prevent the bending of the insertion section 13 of the light applicator 1 shown.

[0043] However, the pre-piercing of the skin 7, or the resulting opening 8, by means of the pre-piercing aid 21 and its axially centrally arranged needle tip 15, reduces the resistance of the skin 7 to such an extent that the operator only needs to exert a small manual force FA on the light applicator 1 to insert the insertion section 13 of the light applicator 1 into the body 9. Therefore, the risk of bending is already greatly reduced. The positioning element 5 and the equally axially central arrangement of the needle tip 25 of the light applicator 1 ensure that, when the light applicator 1 is advanced within the receptacle 3, the needle tip 25 of the light applicator 1 precisely strikes the skin point 8 pre-pierced by the pre-piercing aid 21 and its axially centrally arranged needle tip 15, thus reducing the resistance exerted on the light applicator 1 by the skin.To provide sufficiently precise axial guidance so that, on the one hand, the defined skin point 8 is reached with equal accuracy by both needle tips 15 and 25, and on the other hand, the relatively deep target tissue 11 is precisely targeted by the needle tip 15 of the light applicator 1, the positioning element 5 preferably has a certain thickness in the axial direction of the receptacle 3. That is, the receptacle 3 has a sufficient length to achieve good guidance accuracy.

[0044] Fig. 6a Figure 19 shows a light applicator system in which both the needle tip 25 of the light applicator 1 and the needle tip 15 of the pre-puncture aid 21 are each inserted into their own adapter sleeve 31. This sleeve serves, among other things, to protect the operator, the positioning element 5, and the respective needle tip 15 or 25 itself until the needle tip 15 or 25 exits the receptacle 3 of the positioning element distally. For this purpose, the adapter sleeve 31 can be pre-attached to the pre-puncture aid shaft 23 or the insertion section 13 of the light applicator 1 in a captive and axially movable manner. The respective needle tip 15 or 25 can preferably only move out of its adapter sleeve 31 once the adapter sleeve 31 has reached its final position in the receptacle 3 of the positioning element 5.In the present embodiment, the diameter D1 of the pricking aid shaft 23 and the diameter D2 of the insertion section 13 of the light applicator 1 are the same size, so that the adapter sleeve 31 for the light applicator 1 and the adapter sleeve 31 for the pricking aid 21 can be identical in construction. The inner diameter of the adapter sleeve 31 is adapted to the outer diameter D1 or D2 of the pricking aid shaft 23 or the insertion section 13, respectively, and the outer diameter of the adapter sleeve 31 corresponds, at least in part, to the inner diameter of the receptacle 3 of the positioning element 5. Since, firstly, the adapter sleeve 31 is now...Since their geometry (diameter) is adapted to the insertion section 13 of the light applicator 1, the pre-punching aid shaft 23 and the receptacle 3 in the manner described above, and since both the needle tip 25 of the light applicator 1 and the needle tip 15 of the pre-punching aid 21 are arranged centrally with respect to the axis of the insertion section 13 of the light applicator 1, and the needle tip 15 of the pre-punching aid 21 are arranged centrally with respect to the axis of the pre-punching aid shaft 23, it is ensured that the needle tip 25 of the light applicator 1, after insertion and advancement into the receptacle 3 with its pre-attached adapter sleeve 31, automatically finds the opening 8 already created in the skin 7 by the needle tip 15 of the pre-punching aid 21, in order to significantly reduce the resistance caused by the tough skin 7 that the light applicator 1 experiences when being inserted or advanced into or through the skin 7.In this embodiment, the increased bending stiffness of the pre-piercing aid 21 compared to the light applicator 1 is achieved by making the pre-piercing aid shaft 23 significantly shorter than the insertion section 13 of the light applicator 1, i.e., L1 << L2. Here too, the receptacle 3 has a sufficient length to ensure good guiding accuracy for the light applicator 1 and the pre-piercing aid 21.

[0045] Another embodiment (not shown) is based on the one in Fig. 6a in the illustrated embodiment. However, the adapter sleeves 31 are omitted for both the pre-piercing aid and the light applicator 1. To nevertheless achieve the desired guiding accuracy of the pre-piercing aid 21 and the light applicator 1, as a prerequisite for both the pre-piercing aid 21 and the light applicator 1 to reach the defined position of the opening 8 in the skin 7 (in order to reduce resistance for the light applicator 1 on the skin 7) and for the light applicator 1 to then reach the target point 10 in the organic body 9, the following is done, in contrast to the embodiment of the Fig. 6 , the inner diameter of the receptacle 3 is adapted to the outer diameters D1 and D2 of the pricking aid shaft 23 and the insertion section 13 of the light applicator 1, respectively, which are the same size in this embodiment.

[0046] If the positioning element 5, for example as a hole template, has several receptacles 3 for the simultaneous receptacle of several light applicators 1, then the ones in Fig. 6 and Fig. 6a The illustrated embodiments have the disadvantage that the positioning element 5 is relatively bulky and potentially heavy. While this may be acceptable or even advantageous for certain applications, it is disadvantageous for most. Fig. 7 Figure 5 shows an embodiment of the positioning element 5, in which the positioning element 5 has two axially spaced positioning element components 5a, 5b, each of which has at least one receptacle 3 that is axially aligned with a corresponding receptacle 3 of the other component. Preferably, the axial distance between the positioning element components 5a, 5b is adjustable, as shown in Figure 5. Fig. 7 schematically represented. The greater the distance, the better the guiding accuracy. A smaller distance can be advantageous for handling when positioning the positioning element 5 relative to the organic body 9. In contrast to the embodiments according to Fig. 6 and 6a A corresponding level of guidance accuracy can be achieved with less volume and weight of the positioning element 5.

[0047] Fig. 8 Figure 1 shows an embodiment of the pre-punching aid 21 in which the pre-punching aid shaft 23 has a thickness D1 only in a thickened section 33, which is thicker than the thickness D2 of the insertion section 13 of the light applicator 1, thereby achieving higher flexural rigidity for pre-punching the skin 7. Distal to the thickened section 33, the outer diameter of the pre-punching aid shaft 23 corresponds to the thickness D2 of the insertion section 13 of the light applicator 1. This has the advantage that the receptacle 3 in the positioning element 5 can be designed with a thinner inner diameter D2, so that more receptacles 3 per unit area can be accommodated in the positioning element 5, which is advantageous for the close-spaced positioning of several parallel light applicators 1. Furthermore, no adapter sleeve 31 is required for the light applicators 1.A distal end of the thickened section 33 can act as a stop 35 against the positioning element 5 when a desired pre-punch depth through the skin 7 has been reached.

[0048] In Fig. 9 An embodiment of the invention is indicated by a dashed circle C in which the pre-puncture aid 21 is not a separate component but is integrated into the light applicator. The thickening section 33 can, for example, be realized by a stabilizing sleeve with an outer diameter D1 that can be axially positioned and fixed on the insertion section 13 of the light applicator 1. In this case, the pre-puncture aid shaft 23 is formed by the insertion section 13 of the light applicator 1, and the needle tip 25 of the light applicator 1 is the needle tip 15 of the pre-puncture aid 21. The stabilizing sleeve 33 locally increases the bending stiffness of the insertion section 13 of the light applicator 1, so that it does not bend, or only bends minimally, during pre-puncture into the skin.The stabilizing sleeve 33 can, for example, be fixed at a selected axial position on the peening aid shaft 23 by means of a clamping screw or jaw in order to set the stop position 35 and thus the peening depth and to adapt it to the application.

[0049] Fig. 10 and 11 show different embodiments for the realization of stop 35. In Fig. 8 and 9 A distal end of the thickened section 33 forms the stop 35, which abuts the positioning element 5 when a desired or set pre-puncture depth through the skin 7 is reached. Fig. 10 A distal section of the pricking aid shaft 23 has a smaller diameter D2 compared to a proximal section of the pricking aid shaft 23, which has a larger diameter D1. The proximal section of the pricking aid shaft 23 thus functions as a thickening section 33, the distal end of which forms the stop 35. This is advantageous for the bending stiffness of the pricking aid shaft 23. The embodiment according to Fig. 11 The proximal section of the pricking aid shaft 23 is entirely omitted, as the pricking aid shaft 23 is so short that it consists only of the distal section with the thin diameter D2. The stop 35 is formed here by the handle element 17. The shortness of the pricking aid shaft 23 is advantageous for its bending stiffness.

[0050] Fig. 12 bis 14 This shows a problem with particularly pliable and / or leathery skin 7. During the pre-puncture, the skin 7 may be affected as in Fig. 12 shown yielding distally. This risk is already reduced if the positioning element 5 is adhered to the skin 7. However, the skin 7 can still detach distally and indent instead of opening for the pre-puncture of the needle tip 15 of the pre-puncture aid 21. If this occurs, as shown in Fig. 12 As shown, the pre-punch has virtually no effect until the stop 35 occurs. Since the positioning element 5 obstructs the view of the pre-punch point, the operator may not notice the ineffectiveness of the pre-punch. While the positioning element 5 can preferably be made transparent, at least around the receptacle 3, reflections at optical interfaces may still obstruct the view of the pre-punch point.

[0051] Since the skin 7 stretches during the (unsuccessful) pre-puncture, the reaction force of the skin 7 and the corresponding pressure exerted by the needle tip 15 on the skin 7 increase distally. If one now proceeds as in Fig. 13 Attempts to increase the pre-thread depth by proximally shifting the stop 35 in order to achieve the reaction force of the skin 7 required for a successful pre-thread can be achieved by moving the stop 35 proximally. Fig. 14 The undesired situation shown occurs. The skin 7 opens abruptly at a certain pre-puncture depth and snaps back proximally. Due to the greater pre-puncture depth, the needle tip 15 pierces tissue 26 located beneath the skin 7, into which the pre-puncture aid 21 should not actually be inserted. The pre-puncture is therefore less minimally invasive than desired.

[0052] The in Fig. 15 bis 18 The illustrated embodiment solves the problem in Fig. 12 bis 14 The problem shown is particularly pliable and / or leathery skin 7. For this purpose, a resistance component 37 is provided to allow the skin 7 to generate a reaction force, thereby building up the pressure on the skin 7 necessary for the pre-stitching. The resistance component 37 is a sleeve arranged on the positioning element 5, axially slotted from the proximal side, which forms spring-loaded, radially outwardly yielding spring legs 39 with radially inwardly extending feet 41. The pre-stitching aid shaft 23 has an axial section 43, the outer diameter of which gradually and / or stepwise increases from a distal end 45 proximally to a maximum diameter at a proximal end 47 of the section 43. Proximal to the proximal end 47 of the section 43, the pre-stitching aid shaft 23 is thinner again. Fig. 15 An axial position is shown at the beginning of the pre-stitch, in which the spring legs 39 of the resistance component 37 are relaxed and axially aligned, and the feet 41 at the distal end 45 of section 43 rest against the pre-stitching aid shaft 23. The distal end of the needle tip 15 of the pre-stitching aid 21 still has an axial distance s 1 to the skin 7, which corresponds at least to the axial length s 2 of section 43.

[0053] Will now, as in Fig. 16 As shown, when the pre-piercing aid 21 is pushed distally, the spring struts 39 bend outwards against their radially inward restoring force, as the feet 41 are pushed radially outwards by the increasing diameter. For this to occur, the operator must exert a distally directed manual force on the handle element 17. This force is present when... Fig. 16 The maximum tension of the struts 39 shown is at its maximum when the feet 41 have reached the distal end 47 of the cut 43.

[0054] As soon as the pricking aid 21 is over the in Fig. 16 When the point shown is pushed distally, the shock absorbers 39 snap into place, as shown in Fig. 17 shown, abruptly returning to its relaxed axial alignment. The operator's remaining manual force now leads to a force impulse with a corresponding distal acceleration of the pre-puncture aid 21. The needle tip 15 of the pre-puncture aid 21 thus strikes the skin 7 with this force impulse, which, due to its inertia, cannot yield so quickly, and the pressure is instantly so great that the skin 7 opens for the pre-puncture, as shown in Figur 18 shown.

[0055] The pre-piercing aid 23 forms a stop 35 proximal to the proximal end 47 of section 43 for the feet 41 of the spring struts 39, so that the pre-piercing aid 21 is stopped at the intended pre-piercing depth by the feet 41 striking the stop 35. The distance d 2 of the stop 35 from the proximal end 47 of section 43 corresponds approximately to the thickness d 1 of the skin 7, so that it is completely pierced, but the needle tip 15 does not penetrate, or only penetrates very slightly, into the tissue 26 beneath the skin 7. If the needle tip 15 is to strike the skin 7 at a certain speed, i.e., s 1 > s 2 is, then preferably according to d 2 > d 1 , so that s 1 + d 1 ≈ s 2 + d 2 applies.

[0056] The resistance component 37 can be part of the positioning element 5 or be attached to or attachable to it. Alternatively, the resistance component 37 can be part of the pricking aid 21 and / or be attached to or attachable to it. Preferably, it can be captive and mounted as an axially movable sleeve on the pricking aid shaft 23.

[0057] 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.

[0058] Equivalent embodiments of the parameters, components, or functions described herein, which appear obvious to a person competent in the field, are hereby covered as if they were explicitly described. Accordingly, the scope of protection of the claims shall encompass such equivalent embodiments. Features described as optional, advantageous, preferred, desirable, or similar are to be understood as optional and not as limiting the scope of protection.

[0059] The described embodiments are to be understood as illustrative examples and do not constitute an exhaustive list of possible embodiments. Each feature disclosed in connection with 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. While at least one embodiment is described and shown herein, modifications and alternative embodiments that appear obvious to a person skilled in the art in light of this description are also covered by the scope of this disclosure. Furthermore, the term "have" is not intended to exclude additional features or process steps, nor is "a" or "an" intended to exclude multiple embodiments. Reference symbol list:

[0060] 1 Light applicator 3 Imager 5 Positioning element 7 Skin 8 Position of the pre-puncture, opening in the skin,Pre-pierced skin point 9 Organic body 10 Target point 11 Target tissue 13 Insertion section 15 Pre-piercing aid needle tip 17 Pre-piercing aid handle 19 Light applicator system 21 Pre-piercing aid 23 Pre-piercing aid shaft 25 Light applicator needle tip 26 Subcutaneous tissue 27 Light applicator handle 28 Cutting blade 29 Cutting edge(s) 31 Adapter sleeve 33 Thickening section / Stabilizing sleeve 35 Stop 37 Resistance component 39 Struts 41 Feet 43 Pre-piercing aid shaft section 45 Distal end of pre-piercing aid shaft section 47 Proximal end of pre-piercing aid shaft section D1 Pre-piercing aid shaft diameter L1 Pre-piercing aid shaft length D2 Light applicator insertion section diameter L2 Insertion section length of the light applicator d 1 thickness of the skin s 1 distance of the needle tip of the pre-piercing aid to the skin d 2 distance of the stop from the proximal end of section 43 s 2 axial length of section 43 , d 1 Skin thickness s 1 Distance of the needle tip of the pre-piercing aid to the skin d 2 Distance of the stop from the proximal end of section 43 s 2 Axial length of section 43

Claims

1. A light applicator system (19) for examining and / or treating an organic body (9), wherein the light applicator system (19) has at least one light applicator (1) and a positioning element (5), wherein the light applicator (1) has a distal-side insertion portion (13) comprising at least one element that actively emits light and a needle tip (25), which is arranged centrally in the axial direction with respect to the insertion portion (13), on the distal end in order to pierce into tissue (11) of the organic body (9), wherein the positioning element (5) is at least temporarily fixable in a defined position and orientation relative to the organic body (9) and has at least one receptacle (3) for the at least one light applicator (1), in which the at least one light applicator (1) at least temporarily has a defined position and orientation relative to the organic body (9) and in which the needle tip (25) of the light applicator (1) is guided in an axially centred manner with respect to the at least one receptacle (3) of the positioning element (5), characterised in that the light applicator system (19) has a pre-piercing aid (21) comprising a pre-piercing aid shaft (23) and a distal needle tip (15) which is arranged in an axially centred manner with respect to the pre-piercing aid shaft (23), wherein the pre-piercing aid (21) likewise fits into the at least one receptacle (3) of the positioning element (5) such that the needle tip (15) of the pre-piercing aid (21) is guided in an axially centred manner in this receptacle (3) with respect to the at least one receptacle (3) of the positioning element (5), and in that the pre-piercing aid (21) at least temporarily has a defined orientation relative to the organic body (9), said orientation corresponding to the defined orientation of the at least one light applicator (1) relative to the organic body (9), wherein the light applicator system (19) further has a stop (35), which defines a maximum pre-piercing depth of the pre-piercing aid (21), wherein the pre-piercing aid (21) is integrated into the light applicator (1), wherein the needle tip (15) of the pre-piercing aid (21) is a needle tip (25) of the light applicator (1) that is arranged at least partially distally from the actively light-emitting element and tapers to a point distally and has a light-transparent scatter body for scattering the light of the actively light-emitting element, wherein the stop (35) is positionable and / or formable in such a way that, in a stop position, it defines a maximum pre-piercing depth of the light applicator (1) and, in a non-stop position, it allows a greater piercing depth of the light applicator (1).

2. The light applicator (19) according to claim 1, wherein the pre-piercing aid (21) is a component which is separate from the light applicator (1) and which, following a pre-piercing made in the organic body (9), is removable from the at least one receptacle (3) of the positioning element (5) in order to then introduce the light applicator (1), for examination and / or treatment of the organic body (9), through the at least one receptacle (3) of the positioning element (5) into the pre-pierced organic body (9).

3. The light applicator system (19) according to any one of the preceding claims, wherein the needle tip (25) of the light applicator (1) is guided in the at least one receptacle (3) in an axially centred manner with respect to the at least one receptacle (3) of the positioning element (5) in that an outer diameter of the insertion portion (13) of the light applicator (1) or an outer diameter of an adapter sleeve (31) matching the outer diameter of the insertion portion (13) is matched to an inner diameter of the receptacle (3), and wherein the needle tip (15) of the pre-piercing aid (21) is guided in the receptacle (3) in an axially centred manner with respect to the at least one receptacle (3) in that an outer diameter of the pre-piercing aid shaft (23) or an outer diameter of an adapter sleeve (31) matching the outer diameter of the pre-piercing shaft (23) is matched to the inner diameter of the receptacle (3).

4. The light applicator system (19) according to any one of the preceding claims, wherein the insertion portion (13) of the light applicator (1) has a needle tip (25) that is arranged at least partially distally from the actively light-emitting element and tapers to a point distally and has a light-transparent scatter body for scattering the light of the actively light-emitting element.

5. The light applicator system (19) according to any one of the preceding claims, wherein the needle tip (15) of the pre-piercing aid (21) has one or more cutting edges (29).

6. The light applicator system (19) according to claim 5, wherein at least one of the cutting edges (29) is formed by a distally protruding cutting edge (28).

7. The light applicator system (19) according to any one of the preceding claims, wherein the pre-piercing aid (21) has a pre-piercing aid shaft (23) with an axial length L1 and a diameter D1, which determine a first length to diameter ratio L1 / D1, and wherein the insertion portion (13) of the light applicator (1) has an axial length L2 and a diameter D2, which determine a second length to diameter ratio L2 / D2, wherein the second length to diameter ration L1 / D1 is significantly greater than the first length to diameter ratio L2 / D2.

8. The light applicator system (19) according to any one of the preceding claims, wherein the pre-piercing aid (21) has a pre-piercing aid shaft (23) with a diameter (D1), which fits accurately into an inner diameter of the at least one receptacle of the positioning element and is larger than a diameter (D2) of the insertion portion (13) of the light applicator (1), wherein the light applicator system (19) further has an adapter sleeve (31), the inner diameter of which corresponds accurately to the diameter (D2) of the insertion portion (13) of the light applicator (1) and which has, at least in portions, an outer diameter that fits accurately in an inner diameter of the at least one receptacle (3) of the positioning element (5).

9. The light applicator system (19) according to any one of the preceding claims, wherein the adapter sleeve (31) functions as a protective sleeve of a needle tip of the insertion portion (13) of the light applicator (1) and is coupled in an axially movable manner to the insertion portion (13) in such a way that the adapter sleeve cannot be lost.

10. The light applicator system (19) according to any one of the preceding claims, wherein the pre-piercing aid (21) has a stabilisation sleeve (33), which is axially movable on a pre-piercing aid shaft (23) of the pre-piercing aid (21) and fixable in a selectable axial position on the pre-piercing aid shaft (23).

11. The light applicator system (19) according to any one of the preceding claims, wherein the pre-piercing aid (21) and / or the light applicator (1) has a grip element (17, 27) proximally for manual positioning and orientation.

12. The light applicator system (19) according to claim 11, wherein the axial position of the pre-piercing aid (21) and / or the insertion portion (13) relative to the positioning element (5) is adjustable manually by positioning of the grip element (17, 27) in the axial direction.

13. The light applicator system (19) according to claim 11 or 12, wherein the grip element (17, 27) forms the stop (35) and is movable axially on the pre-piercing aid (21) and / or the insertion portion (13) and is fixable in a selectable axial position.

14. The light applicator system (19) according to any one of the preceding claims, further comprising a resistance component (37), which exerts a proximally directed resistance force against a distally directed force exerted manually onto the pre-piercing aid (21) up to a maximum resistance force and suddenly releases the pre-piercing aid (21) distally as soon as the distally directed manual force on the pre-piercing aid (21) exceeds the maximum resistance force.

15. The light applicator system (19) according to claim 14, wherein the resistance component (37) is elastically resiliently deformable at least in part and can be tensioned by the distally directed manual force.

16. The light applicator system (19) according to claim 14 or 15, wherein the resistance component (37) has at least one substantially axially extending spring leg (39) with foot (41), wherein the foot (41) is pushed away radially by the distally directed manual force with tensioning of the spring leg (39) and snaps back with sudden relief of the spring leg (39) when the maximum resistance force is exceeded.