Marker for marking tissue

Abstract

The invention relates to a marker body for marking a body tissue. The marker body has a shape which is at least approximately rotationally symmetrical about a longitudinal axis, is formed from mutually connected, elastic and pre-shaped metal struts, and can assume a radially compressed and a radially expanded state. The marker body in its expanded state is constricted in a central longitudinal section and flares out in the longitudinal direction from the central longitudinal section to both sides. The marker body has two flared longitudinal sections, the maximum outer diameter of which is two to twenty times the outer diameter of the central longitudinal section in the expanded state of the marker body. The marker body is formed in the circumferential direction at least in the flared longitudinal sections by 10 to 40 struts which in the compressed state of the marker body extend essentially in the longitudinal direction of the marker body and which are connected to one another at intersection points.

Description

TECHNICAL FIELD

[0001] The invention relates to a marker body which is provided for implantation into soft tissue, such as adipose tissue, muscle tissue, tumor tissue, breast tissue, liver tissue, lymph nodes, in particular underarm lymph nodes, etc., which has an elastic, compressible and self-expanding carrier structure. The carrier structure is formed by an elastic and pre-shaped support. The marker body has a shape which is at least approximately rotationally symmetrical about a longitudinal axis. The invention also relates to an implantation system and a method for implantation. BACKGROUND

[0002] Implantable marker bodies for identifying tissue sites are known. Such marker bodies are usually constructed in such a way that they can be implanted into the tissue region to be identified by suitable means in order to remain there durably or for a certain period of time, for example between two operations. In this way, tissue which is relevant for therapy, for example with a tumor or other tissue abnormalities, or also potentially healthy tissue which needs to be observed, can be identified for a longer period of time. The identifying effect of these marker bodies is achieved by the visibility of these marker bodies at the time of examination by imaging diagnostic methods, in particular in methods based on X-ray radiation, nuclear magnetic resonance or ultrasound.

[0003] WO 2006 / 000568 A2 discloses a marker for marking a tissue site after insertion of the marker using an applicator or cannula of a known construction type. It is achieved here that the marker remains in the tissue site to be marked for a longer period of time and thereby clearly marks the tissue site for subsequent diagnostic and therapeutic activities. The marker consists of one or more threads which are twisted in a central marker section and can have different shapes on the two end sections of the marker.

[0004] A surgical instrument, in particular a marking instrument for marking a body tissue section, is also described in EP 1 782 745 B1. The instrument is particularly suitable for marking tumor tissue before surgical removal of the tissue.

[0005] A manufacturing method for manufacturing spherical cage structures consisting of nitinol for use in the field of surgical orthopedics for the treatment of bone necrosis is disclosed in US 8 112 869 B2. The cage structures manufactured according to the method described there are provided for stabilizing the femoral head by being introduced in compressed form through a channel drilled in the femur, expanded in the femoral head and the cavity subsequently filled with compacted bone chips. The diameter of the cage structures varies in this field of application between 20 and 30 mm.

[0006] A marking system for a biopsy of a breast is described in US 9 216 069 B2, wherein a plurality of marking elements, which contain at least one X-ray opaque thread segment, are preloaded compressed in a supply tube.

[0007] US 8 060 183 B2 generally discloses a marker comprising a cavity for identification at a biopsy of a breast in an imaging method. In a variant, the marker consists of an outer hollow body closed at two elongated ends and a smaller permanent marker within the outer body. It is furthermore described that the outer hollow body consists of a bioabsorbable material and dissolves within a certain period of time, whereas the inner permanent marker continues to remain in the tissue. SUMMARY

[0008] It is the task of the present invention to provide an improved marker for implantation into tissue.

[0009] To solve this task, a marker according to the invention is proposed. Thereby, the marker has an at least approximately rotationally symmetrical shape around a longitudinal axis and can assume a radially compressed state and a radially expanded state. The marker consists of elastic and pre-shaped supports, which form an elastic, compressible and self-expanding carrier structure. The supports are interconnected, for example by weaving or other means. The marker in its expanded state is constricted in a central longitudinal section and widens from the central longitudinal section in longitudinal direction towards both longitudinal ends, so that the marker has two widened longitudinal sections, which can for example each have an approximately conical shape, wherein the conical tips contact each other. The maximum outer diameter of the widened longitudinal sections is two to twenty times the outer diameter of the central longitudinal section in the expanded state of the marker. The marker consists of 5 to 96 supports in circumferential direction at least in the widened longitudinal sections, which in the compressed state of the marker extend essentially in their longitudinal direction and the supports are pairwise crossed at their longitudinal ends and are there materially and / or form-locked interconnected with each other. Extending essentially in the longitudinal direction of the marker means that the supports in the compressed state of the marker extend at an angle of less than 10° with respect to the longitudinal axis of the marker.

[0010] Such a marker can advantageously fulfill two requirements: The marker on the one hand provides good ultrasound visibility and on the other hand resists migration, i.e. wandering, of the marker in the tissue during and after implantation.

[0011] If a biopsy, for example a vacuum biopsy, is performed before the marking, the tissue pressure acting against the propagation direction of the marker body is correspondingly smaller or non-existent due to the already existing cavity. In this case, the expansion of the marker body after the placement prevents the marker body from falling back into the biopsy cannula or being flushed out through the puncture channel of the vacuum biopsy unit.

[0012] As a further aspect of the application, an implant system with a marker body and an implant device is proposed.

[0013] The considerations on which the application is based are that the visibility of the marker body should also be ensured in imaging methods based on different action principles. Furthermore, the unambiguous and clear visibility of the marker body should be ensured over as large a bandwidth of examination conditions and application cases as possible. In ultrasound-based imaging methods, good recognizability of the marker body is achieved by as high a sound reflection as possible of the carrier structure composed of metal or hard plastic.

[0014] In ultrasound examinations with medical ultrasound waves in the B mode (brightness modulation) in the range from 1 MHz to 40 MHz, the incident ultrasound waves are made to impinge on the structure with a circular cross section transversely to the two longitudinal end portions of the marker body by the carrier structure of the marker body. By means of coordinated parameters, namely support diameter (or width and thickness), support number, support density and support material, it is achieved that only a portion of the sound energy is reflected by the structure and the remaining portion of the energy is allowed to pass through. As a result, a complete circle is formed in the ultrasound image as a display. In other structures of this type, the ultrasound energy is reflected to a large extent on the first surface of the marker and a shadow is produced in the image.

[0015] A further feature of the selected marker body geometry is that the incident ultrasound waves on the two longitudinal end portions of the marker body can be recognized in the cross section according to a cross instead of a circle in the ultrasound image. Both the circular and the cross geometry do not occur in the form of an ultrasound image of biological tissue and can thus be particularly simply recognized and assigned to the marker body for the examiner.

[0016] In imaging methods based on X-ray radiation, for example mammography, the high absorption of the X-ray radiation by the carrier structure also leads to good recognizability in the X-ray image. The high absorption of the X-ray radiation by the carrier structure results from the metal of the carrier structure, for example metal wires or metal particles embedded in plastic.

[0017] In magnetic resonance tomography (MRT), the magnetic properties of the marker body material result in its good recognizability.

[0018] It is provided in particular that the carrier structure is woven, interwoven, wound or knitted. The advantage here is the economic manufacturability of a structure which is widened on one face, which is then processed in a subsequent manufacturing step into a hollow double-cone shape, wherein the cone tips meet in the center.

[0019] Alternatively, the carrier structure can consist of a small tube which is slit in the longitudinal direction, which is compressed such that the segments separated from one another by the slits arch outwards. When the compressed state of such a carrier structure is its relaxed state, the carrier structure expands itself.

[0020] A further alternative for the carrier structure is a carrier structure made of plastic, for example a marker body made of PEEK manufactured in an injection molding process.

[0021] The carrier structure of the marker body is preferably configured such that it expands itself and can be elastically compressed under a radial force of at least one Newton. When the marker body is implanted in the tissue in the elastically compressed state, it automatically transitions into its expanded state and remains in this expanded state when the tissue exerts a radial force of less than one Newton on the marker body.

[0022] For implantation, the marker body is first brought to the desired location with the aid of a cannula and then pushed out of the inner lumen of the cannula, so that it can subsequently widen in the tissue. The expansion force with which the marker body compressedly held in the cannula widens immediately after being ejected from the cannula is preferably at least 1 Newton.

[0023] The carrier structure of the marker body can be configured, for example, such that the carrier structure has an expansion force which is greater than 40 Newtons in the state of the marker body compressed to a maximum diameter of less than 1 mm and is always greater than three Newtons, for example six Newtons, at a maximum diameter of 1.5 mm. The carrier structure of the marker body can be configured such that the expansion force of the carrier structure essentially corresponds to the minimum radial force which must be applied in order to elastically compress the marker body.

[0024] The energy stored in the carrier structure of the marker body can be set by suitable selection of the support thickness of the carrier structure or the number of supports of the carrier structure. Furthermore, the energy stored in the carrier structure of the elastically compressed marker body also depends on the material from which the supports of the carrier structure of the marker body are formed. The marker body according to the application can accordingly also be manufactured such that a radial force of more than 1.5 Newtons, two Newtons or even more than three Newtons must be used in order to compress the marker body to a maximum diameter of less than 1.5 mm. The marker body according to the application can likewise be manufactured such that a radial force of 0.5 Newtons is already sufficient to compress the marker body to a maximum diameter of less than 1.5 mm.

[0025] Since the carrier structure of the marker body is configured to be self-expanding, the marker body automatically transitions into its expanded state as soon as the radial force required for the elastically compressed marker body is undershot. The carrier structure of the marker body is preferably composed of interwoven single wires. The support of the marker body is thus preferably composed of 5 to 96 wires, for example of 18 to 48 wires, in particular of 24 or 36 wires, which respectively extend from one longitudinal end of the marker body to the other longitudinal end and cross over multiple times and in this way compose a grid-like carrier structure from a wire mesh having multiple intersection points. Particularly preferred is a marker body composed of 12 to 48, in particular 24, interwoven wires, which are preferably composed of a titanium alloy, in particular Nitinol.

[0026] The support of the marker body, i.e. the wires, are here preferably pairwise connected to one another on their free longitudinal ends and particularly preferably welded, in particular twisted and welded. To this end, the free longitudinal ends are preferably respectively at an intersection point of the carrier structure, i.e. for example where the wires cross over in the wire mesh.

[0027] The support of the marker body can also be connected to one another at the intersection points materially, in particular welded. However, this is preferably not provided.

[0028] Alternatively or additionally, the support of the marker body can be twisted to one another at the intersection points.

[0029] Preferably, the outer diameter of the marker body in its expanded state continuously increases in the longitudinal direction from the central longitudinal section towards the two longitudinal ends, so that the marker body has its maximum diameter on its two longitudinal ends.

[0030] In an alternative embodiment variant, the outer diameter of the marker body in its expanded state firstly increases in the longitudinal direction from the central longitudinal section towards the two longitudinal ends and then re-decreases in further extension towards the longitudinal ends, so that the marker body has its maximum diameter at a distance from its respective longitudinal end.

[0031] In both cases, the marker body desirably has the same maximum diameter in the widened longitudinal sections. In practice, however, the two maximum diameters are typically different from one another, but the difference in maximum diameter is preferably less than 10% in the radially unloaded state of the marker body.

[0032] Preferably, the marker body widens in the expanded state in the widened longitudinal sections at an opening angle of between 25° and 50°, in particular between 30° and 45°, with respect to the longitudinal axis of the marker body.

[0033] In the marker body formed from the interwoven threads, the thread diameter is preferably less than 0.5 mm, preferably less than or equal to 0.1 mm, for example between 0.05 mm and 0.10 mm. A small thread diameter has a positive effect on the compressibility of the marker body, which is desirable when implanting through a cannula having the smallest possible diameter. A larger thread diameter, on the other hand, has a positive effect on the setting force of the load-bearing structure of the marker body. This results in the marker body also being able to expand against tissue pressure present in hard tissue, for example in tumor tissue.

[0034] It is furthermore advantageous if the diameter of the marker body in the expanded state is less than 10 mm or less than 8 mm, preferably between 3.0 mm and 5.0 mm. A marker body in this diameter range is a compromise between the visibility in imaging methods on the one hand and the spatial requirements of a foreign body in the tissue on the other hand.

[0035] An expanded marker body having a certain minimum size offers the advantage that the marker body can be felt by the operating surgeon during the treatment.

[0036] It is furthermore preferred if the diameter of the marker body in the compressed state is less than 3 mm, preferably less than 1.0 mm. A small diameter or high compressibility of the marker body in the elastically compressed state enables the marker body to be implanted using a relatively thin, i.e. having a small diameter, cannula. The use of a small diameter reduces the risk of injury and pain for the patient and can dispense with an incision and / or anesthesia in the range of a simplified procedure. Advantages also arise in terms of the duration of use and the costs of use.

[0037] Preferably, the load-bearing structure, for example its threads and / or sleeve, is roughened, for example by sandblasting, in order thereby to improve the ultrasound visibility.

[0038] The support of the marker body is preferably composed of a titanium alloy, in particular Nitinol. This results in the advantage due to the material properties of Nitinol as a superelastic material that the marker body automatically transitions from the elastically compressed state to the expanded state after the application from the implantation device, in particular against a pressure acting on the tissue adjoining the marker body in the opposite direction to the expansion direction. Further superelastic materials and / or shape memory alloys can also be used.

[0039] The rapid self-expansion of the marker body after its implantation, for example by using Nitinol, is decisive for preventing migration of the marker body, in particular during and after the implantation.

[0040] It is furthermore advantageously provided that the material of the load-bearing structure is non-absorbable. This aspect of the application brings the advantage that the marker body, which usually remains in the tissue for a longer period of time, does not degrade. It is thereby also prevented that the marker body interacts in an adverse manner with the adjoining tissue, in particular due to the release of inclusions or material components of the load-bearing structure at the adjoining tissue.

[0041] The wires of the carrier structure formed by a plurality of wires do not necessarily all consist of the same material. Rather, individual wires consisting of other materials can also be interwoven together in order to optimize the visibility in magnetic resonance tomography or also to improve the X-ray visibility under computer tomography or C-arm. Suitable materials are, for example, titanium, gold, iron-containing alloys and / or nitinol.

[0042] Especially when the carrier structure of the marker body consists of a wire mesh, the central longitudinal section can be provided with a sleeve which compresses the central longitudinal section to a minimum diameter, precisely preferably such that all the struts lie directly laterally against one another in the central longitudinal section. The sleeve has the additional effect that it holds all the individual wires together, for example clamped, such that the connection of the individual wires at their longitudinal ends is superfluous, but can be provided for redundancy reasons.

[0043] Preferably, the sleeve is a nitinol sleeve. Instead of a nitinol sleeve, other clamps can also be used, for example sleeves made of other materials. Such clamps can also have different shapes. The clamps can thus differ from one another, for example by shape and length. This allows the use of marker bodies with different clamps, such that individual marker bodies can also be identified individually after implantation.

[0044] A further distinguishing feature of individual marker bodies can be clamps made of different materials, for example more or less radiopaque clamps, or also clamps with different magnetic properties, especially for distinguishing images of magnetic resonance tomography recordings. Clamps with air / gas inclusions lead to improved recognizability of ultrasound images.

[0045] It is furthermore advantageously provided that the marker body comprises, in addition or in addition to the carrier structure, an identification feature, for example a sleeve of different shape and / or length, especially a metal or other X-ray opaque molding within the carrier structure. An advantage achieved thereby is, among others, that a plurality of different marker bodies implanted simultaneously in a patient can be distinguished unambiguously or at least more simply by imaging methods. These moldings can be, for example, rods or balls inside or fastened to the carrier structure, which can also have different sizes for better differentiation. These moldings can be formed, for example, from metal.

[0046] Another aspect is an implantation system with marker bodies and implantation devices of the type claimed herein.

[0047] The implantation device is configured for implanting the marker body according to the application and for this purpose has a cannula. The marker body can thus advantageously be positioned at the tissue site to be identified by the implantation device by piercing the skin layer and the tissue lying thereunder, especially in the case of use of imaging methods. It is advantageously provided that the outer diameter of the cannula of the implantation device is less than 3 mm, preferably between 1.6 mm and 1.2 mm. This results in the advantage that the implantation of the marker body can take place in a percutaneous manner, especially due to the small cannula diameter. The implantation of the marker body can be achieved especially by the small outer diameter of the cannula without having to rely on an incision of the skin or an anaesthetisation of the associated tissue at the entry site of the cannula.

[0048] With the entire system, the marker body can be applied with a suitable and dimensionally suitable implantation device. Especially the implantation system as an entire system not only with the marker body but also with the implantation device can comprise in the delivery state the marker body already in a compressed and in the cannula lying state, so that the method steps of compressing the marker body and the step of preloading the implantation device are omitted for the user and in this way the application is further simplified.

[0049] According to the application, a method for manufacturing a marker body is also proposed. The method has the following steps:

[0050] - providing a tubular wire mesh having two longitudinal ends and being formed from 5 to 96 interwoven single wires, and

[0051] - constricting the wire mesh in a central longitudinal section, so that the wire mesh widens from the central section in longitudinal direction towards both sides and forms two widened longitudinal sections.

[0052] Preferably, the method has the following further method steps:

[0053] - braiding the single wires into a tube so that the single wires are alternately overcrossed and undercrossed at the crossing points, wherein the crossing points are approximately arranged on a crossing point plane which extends transversely to the longitudinal axis of the tube, and

[0054] - disconnecting the tube section by laser cutting the wires at all crossing points of a separation plane, which is the crossing point plane, to provide a tubular wire mesh. The tubular wire mesh disconnected from the tube can then be shaped into a marker body.

[0055] Preferably, the single wires are welded to each other in pairs when disconnected.

[0056] Preferably, the single wires are twisted into each other at the crossing point plane provided as separation plane by winding each two single wires around each other by at least 180°, preferably 360°, 540° or 720°.

[0057] Preferably, the single threads cross over or under 8 to 12 times, preferably 9 to 11 times or 10 times between the longitudinal ends of the hose-like thread mesh. Correspondingly, every ninth to thirteenth, preferably every tenth, eleventh or twelfth intersection plane of the hoses interwoven by the single threads is a separation plane, on which the single threads are preferably twisted into each other in pairs.

[0058] The marker bodies of the type described herein are used for percutaneous marking in soft tissue, for example breast tissue, and for marking axillary lymph nodes after previous biopsy of lymph nodes.

[0059] Fields of application include marking of suspicious tissue, marking of lesions before or during chemotherapy, and marking of biopsy sites. It is also possible to mark the location of a resected tumor for better orientation of the radiation plan.

[0060] The marker bodies can be used in the context of surgery as follows:

[0061] The marker body is implanted at the desired site by first inserting the cannula of the implantation device with its distal end into the body tissue until the desired implantation site is reached and ejecting the marker body from the distal end of the cannula. Alternatively, the cannula tip of the implantation device can also be placed at the desired implantation site by means of a sheath already in the patient.

[0062] The body tissue can then be examined using an imaging ultrasound method, in which the marked tissue is sonographed. In the sonogram, the marker body can be recognized due to the circular or X-shaped artifact.

[0063] Preferably, the marker body is used for marking in adipose tissue, muscle tissue, tumor tissue, breast tissue, liver tissue and / or lymph nodes, in particular axillary lymph nodes. BRIEF DESCRIPTION OF DRAWINGS

[0064] Further advantages, features and details of the application result from the following description of preferred embodiments and the illustrative drawings, in which:

[0065] Figure 1 : shows a marker body shown schematically in a side view;

[0066] Figure 2 : shows a marker body shown in Figure 1 in an end view;

[0067] Figure 3 : shows a marker body shown schematically in a side view;

[0068] Figure 4 : shows a marker body shown in Figure 3 in an end view;

[0069] Figure 5: shows the marker body in a side view;

[0070] Figure 6 : shows the marker body in an end view; Figure 5

[0071] Figure 7 : shows the marker body in a side view;

[0072] Figure 8 : shows the marker body in an end view; Figure 7

[0073] Figure 9 : illustrates stages of a manufacturing method for manufacturing a marker body;

[0074] Figure 10A , B, C: shows schematically an implant system with a marker body and an implant device;

[0075] Figure 11 : shows a marker body with a load bearing structure formed by 24 wires;

[0076] Figure 12 : shows the marker body shown in Figure 11 in a further view, in which the end side of the marker body is visible;

[0077] Figure 13 : shows a side view of the marker body in Figure 11 and Figure 12 in combination with a ruler;

[0078] Figure 14 : shows an end view of the marker body in Figure 11 and Figure 12 in combination with a ruler;

[0079] Figure 15 : shows a perspective view of the marker body shown in Figure 3 and Figure 4 ;

[0080] Figure 16 : shows a marker body made of a wire mesh, which is similar to the marker bodies shown in Figure 3 , Figure 4 and Figure 15 ;

[0081] Figure 17 : shows a marker body made of a wire mesh, which is similar to the marker body shown in Figure 16 , which has an additional central sleeve;

[0082] Figure 18 : shows a wire mesh as a section of an interwoven hose, which can be used for forming a marker body as in Figure 16 and​​Figure 17 starting product of the marker shown;

[0083] Figure 19 : shows a section of a hose interwoven by threads, from which section three thread meshes according to the invention can be produced by breaking apart; Figure 18

[0084] Figure 20 : shows the interwoven thread tube according to the invention, wherein the threads are severed at two locations by means of laser; Figure 19

[0085] Figure 21 : Figure 16 perspective view of the marker shown in

[0086] Figure 22 : Figure 16 further side view of the marker shown in

[0087] Figure 23 a) to h): show different cross-sectional shapes of the support for the marker in Figure 23 Figure 1 and Figure 2

[0088] Figure 24 a) to f): show different variants of how the individual supports of the marker in Figure 24 Figure 1 and Figure 2

[0089] Figure 25 a) to f): show different variants of how the free ends of the two supports of the marker according to Figure 25 Figure 1 and Figure 2

[0090] Figure 26 a) and b): show plan views of the implant device according to Figure 26 Figures 1 to 25

[0091] Figure 27 : shows a further view of the implant device in Figure 26

[0092] Figure 28 : shows an ultrasound image with artifacts of the marker, viewed from the side; and

[0093] Figure 29 : shows an ultrasound image with artifacts of the marker in the longitudinal direction. DETAILED DESCRIPTION

[0094] ​​​​​​​​​​​Figure 1 The marker body 100 is shown in a schematic representation in a side view. Figure 2 The same marker body 100 is shown in an end view.

[0095] The marker body 100 is composed of a laser-cut small tube.

[0096] The marker body 100 is shown in an expanded state and has two flared longitudinal sections 102, 104 and a central longitudinal section 106 between the two longitudinal sections 102, 104.

[0097] The two flared longitudinal sections 102, 104 are each flared conically from the central longitudinal section 106. Accordingly, the outer diameter of the flared longitudinal sections 102, 104 continuously increases from the central longitudinal section 106. On each longitudinal end of the marker body 100, the outer diameter is largest in the respective flared longitudinal section 102, 104.

[0098] In the two flared longitudinal sections 102, 104, the marker body 100 has a grid-like load-bearing structure composed of struts 103 with a plurality of intersection points 105. In order to bring the marker body 100 into its elastically compressed state, the grid-like load-bearing structure can be pressed radially in the two flared longitudinal sections 102, 104, so that the meshes 108 of the respective load-bearing structure are closed in the direction of the longitudinal axis 110 of the marker body. The effective length of the marker body 100 is accordingly greater in the compressed state than in the expanded state. In order to bring the marker body 100 into the elastically compressed state, a radial force of at least one Newton must be exerted on the marker body 100 in the two flared longitudinal sections 102, 104. The marker body 100 is therefore designed such that, when the counterforce of the tissue is less than one Newton, the marker body exerts a radial force of approximately one Newton on the surrounding tissue in the compressed state and expands the surrounding tissue. In an embodiment not shown here, the marker body has struts with a strut thickness that differs from the strut thickness of the struts 103, so that a comparatively large radial force of, for example, at least 1.5 Newtons must be exerted on the marker body in order to elastically compress the marker body.

[0099] In the central longitudinal section 106, the small tube is not laser-cut and accordingly has a closed sleeve-like load-bearing structure.

[0100] The marker 100 is rotationally symmetric about its longitudinal axis 110. In the expanded state, the marker 100 has a length L1 of 7 mm. The tube constituting the marker 100 has an inner diameter of 0.458 mm, an outer diameter of 0.762 mm, and a wall thickness of 0.152 mm. In the central longitudinal section 106, the marker 100 retains its original dimensions even after the marker is laser-cut into adjacent longitudinal sections 102, 104. The marker 100 may be made of, for example, titanium alloy, especially nitinol.

[0101] In embodiments not shown here, the marker is composed of a tube of other dimensions, but in other cases is laser-cut to form the structure as described in the reference. Figure 1 The described marker body has a central longitudinal section and two widened longitudinal sections extending from the central longitudinal section. Such a tube may, for example, have an outer diameter between 0.6 mm and 0.08 mm, an inner diameter between 0.3 mm and 0.5 mm, and a wall thickness between 0.1 mm and 0.5 mm.

[0102] In the widened longitudinal sections 102 and 104, the maximum outer diameter A1 of the marker body 100 is 3.5 mm, and in alternative embodiments it may be between 3 mm and 4 mm, for example. In the central longitudinal section 106, the inner diameter l1 is 0.458 mm.

[0103] Figure 3 The marker body 100 is shown schematically in an expanded state in a side view. Figure 4 Marker body 100 is shown in end view.

[0104] The marker body 100 includes a support structure formed by a mesh 301. Lines 308 extend from one longitudinal end of the marker body 100 to its other longitudinal end. During its journey from one longitudinal end to the other, the lines 308 intersect and, in particular, interweave with each other; that is, each line 308 alternately leads below and then above the other lines 308 of the mesh 301. This results in a grid-like support structure with a plurality of intersections 310. (See attached diagram.) Figure 3 and Figure 4 The illustrations in the figures should be noted to be detailed and accurate, as these figures do not reproduce the intersection 310, where every two lines 308 contact, are welded together, or twisted together. The intersection 310 (where every two lines 308 contact each other) can be seen, for example, in reference [reference missing]. Figure 11 and Figure 12 The markings described and shown are implemented in the same way as in a network of intersecting lines.

[0105] With reference Figure 11 and Figure 12The wires 1102 of the described marker 100 differ in that the wires 308 are welded to each other at the intersection points 310, i.e. are materially connected to each other. Alternatively or in addition to the welding, the wires 308 at the intersection points 310 can also be twisted into each other. In particular, the free ends 312 of the wires 308 at the respective longitudinal ends 314, 316 of the marker 100 are welded to one or more free ends of further wires 308, respectively.

[0106] As described with reference to the marker 100, Figure 1 and Figure 2 The marker 100 has widened longitudinal sections 302, 304 and a central longitudinal section 306 arranged between these widened longitudinal sections 302, 304. The outer diameter of the two widened longitudinal sections 302, 304 continuously increases in the direction of the longitudinal ends of the marker 100 from the central longitudinal section 306. The outer diameter of the marker 100 in the two longitudinal sections 302, 304 is respectively largest at the longitudinal ends.

[0107] The wire mesh 301 comprises 24 wires made of nitinol and has a diameter of 0.12 mm. In an alternative embodiment of the marker, not shown here, the wire mesh comprises between 10 and 40 wires, which are welded and / or twisted into each other at the intersection points of the wires. In an embodiment not shown here, the marker is composed of a wire mesh of wires having a diameter of between 0.10 mm and 0.14 mm. Wires composed of a titanium alloy other than nitinol can also be used.

[0108] The marker 100 has a length L2 of 6 mm, but can also be between 5 mm and 7 mm in an alternative embodiment not shown here.

[0109] The central longitudinal section 306 of the marker 100 is provided with a sleeve, in particular a nitinol sleeve 318, which compresses the wire mesh 301 in the central longitudinal section 306 to a defined outer diameter.

[0110] The maximum outer diameter A2 of the marker in the two widened longitudinal sections 302, 304 is 4 mm and can be between 3.5 mm and 4.5 mm in an alternative embodiment not shown here.

[0111] In order for the marker 100 to pass from the expanded state into the elastically compressed state, a radial force of at least one Newton has to be exerted on the marker 100. The marker 100 is therefore designed such that, when the counterforce of the tissue is less than one Newton, the marker exerts a radial force of approximately one Newton on the surrounding tissue in the compressed state and expands it.

[0112] In an alternative embodiment, not shown here, the self-expanding marker body 100 can have more wires and correspondingly more intersections, so that the self-expanding marker body is relatively stiffer. Correspondingly, a relatively larger radial force is necessary to bring the marker body into the elastically compressed state. Likewise, in an alternative embodiment, not shown here, the number of wires can be smaller in order to achieve a marker body that has already transitioned from below one Newton into its elastically compressed state under the applied radial force.

[0113] In Figure 5 The expanded marker body 100, shown in a side view in Figure 6 The marker body 100 is shown in an end view in

[0114] The central longitudinal section 502 comprises one coil, but in an alternative embodiment, not shown here, can also comprise a plurality of coils, preferably with a constant outer diameter. On both sides of the central longitudinal section 502 along the longitudinal axis 504 of the marker body 100, respectively, a widened longitudinal section 506, 508 is connected, the outer diameter of which continuously increases from the central longitudinal section 502. That is to say, the outer diameter of the marker body 100 increases from coil to coil starting from the central longitudinal section. In the expanded state of the marker body 100 shown here, the helical carrier structure has an angle W1 of 30°. The marker body 100 can be brought into an elastically compressed state by pulling the helical carrier structures away from each other, so that the angle is reduced. In order to bring the marker body 100 into the elastically compressed state, a radial force of at least one Newton must be applied to the marker body. The marker body 100 is therefore designed such that, when the counterforce of the tissue is less than one Newton, the marker body exerts a radial force of approximately one Newton on the surrounding tissue in the compressed state and expands it.

[0115] The marker body 100 has a length L3 of 6 mm, but in an alternative embodiment, not shown here, can also be between 5 mm and 7 mm.

[0116] The maximum outer diameter A3 of the marker body 100 in the widened longitudinal sections 506, 508 is 5 mm and in an alternative embodiment, not shown here, can also be between 4 mm and 6 mm, but in particular also less than 4 mm.

[0117] Figure 7 The expanded marker body 100 is shown in a side view. In Figure 8 The marker body 100 is shown in an end view in

[0118] The marker body 100 has two widened longitudinal sections 702, 704 and a central longitudinal section 706 between the two widened longitudinal sections 702, 704. As with the marker body 100 shown in Figure 1and Figure 2 The marker 100 is formed of laser-cut small tubes, like the marker described. In particular, the marker 100 is laser-cut in the two widened longitudinal sections 702, 704 and is not laser-cut in the central longitudinal section 706. Accordingly, the marker 100 has a lattice-like load-bearing structure in the two widened longitudinal sections 702, 704 in the expanded state, whereas the load-bearing structure is closed and sleeve-like in the central longitudinal section 706.

[0119] Unlike the marker described with reference to Figure 1 and Figure 2 Unlike the marker described, the marker 100 is not continuously widened in the two expanded longitudinal sections 702, 704 all the way to the longitudinal ends of the marker 100, but only from the central longitudinal section all the way to approximately the center of the respective widened longitudinal section 702, 704. Thereafter, the outer diameter of the marker in the respective widened longitudinal section 702, 704 is essentially constant in the direction of the respective longitudinal end of the marker 100.

[0120] In an alternative embodiment, not shown here, the outer diameter of the marker is not constant between the centers of the approximately respective widened longitudinal section in the direction of the respective longitudinal end of the marker, but decreases, so that the shape of the respective widened longitudinal section is at least approximately spherical or ellipsoidal.

[0121] The marker 100 has a length L4 of 7 mm, but in an alternative embodiment, not shown here, between 4 mm and 10 mm. In the central longitudinal section 706, the dimensions of the marker 100 correspond to the original dimensions of the small tubes that make up the marker 100. In the central longitudinal section 706, the marker 100 has an outer diameter of 0.762 mm, an inner diameter of 0.458 mm and a wall thickness of 0.152 mm. In alternative embodiments, not shown here, of the marker, the marker has an outer diameter between 0.6 mm and 0.08 mm, an inner diameter between 0.3 mm and 0.5 mm and a wall thickness between 0.1 mm and 0.5 mm in the central longitudinal section.

[0122] In the two widened longitudinal sections 702, 704, the marker 100 has a maximum outer diameter A4 of 3.5 mm, but can also be between 3 mm and 4 mm in an alternative embodiment, not shown here. The inner diameter l2 of the marker 100 in the central longitudinal section 706 is 0.458 mm.

[0123] To compress the marker body 100 elastically, a radial force of at least one Newton has to be applied to the marker body. When the marker body 100 is implanted into tissue, the marker body automatically transitions into its expanded state and remains in this expanded state when the radial force applied to the marker body 100 by the tissue is less than one Newton. The marker body 100 is thus designed such that it exerts a radial force of about one Newton on the surrounding tissue and expands the surrounding tissue in the compressed state when the counterforce of the tissue is less than one Newton.

[0124] Figure 9 Different stages of a manufacturing method for manufacturing a marker body having a load bearing structure formed by a wire mesh are shown. For example, reference is made to Figure 3 and Figure 4 The marker bodies described can be manufactured according to the following method.

[0125] First, a hose-like wire mesh is provided in step S1, which can have between 20 and 40 single wires interlaced with each other and thus crossing at the intersection points. At the intersection points, the wires are preferably materially bonded to each other or are interwoven.

[0126] A sleeve is pushed onto the hose-like wire mesh such that a section of the wire mesh is exposed between the two sleeves and the two sleeves are oriented coaxially to each other.

[0127] Subsequently, the sleeves are moved towards each other in the longitudinal direction of the hose-like wire mesh, in particular without relative movement between the respective sleeve and the wire mesh enclosed by the sleeve. Thereby, the wire mesh exposed between the sleeves is compressed in the longitudinal direction and widened in the radial direction (step S2).

[0128] The two sleeves can be moved towards each other to such an extent that the wire mesh is partially rolled up (step S3).

[0129] Furthermore, the wire mesh in the central longitudinal section is contracted in the center of the exposed wire mesh, for example by winding a Nitinol wire around the wire mesh (step S4). This can be carried out before the widening and, if necessary, after the rolling up.

[0130] Then, the wire mesh can be cut perpendicular to the longitudinal direction of the wire mesh on both sides of the central longitudinal section and the cut-off parts of the wire mesh, for example the rolled-up parts, are removed. Preferably, the cut is carried out on already existing intersection points of the wire mesh, which lie in a plane extending transversely to the longitudinal direction of the wire mesh. The longitudinal ends of the wires are thus connected to each other in pairs.

[0131] If the cut is not carried out on already existing intersection points and thus free ends of the wire mesh are produced, the free ends can be interwoven and / or welded.

[0132] Figure 10AAn implant system 1000 is shown, which has a marker body 100 of an implant device 1004. Here, the marker body 100 is in a preloaded state, that is to say, with a compressed carrier structure, within a cannula 1006 of the implant device 1004. This state of the implant system 1000 represents a typical delivery state, in which the implant system 1000 is provided for use by a user, for example a surgeon.

[0133] The implant portion 1008 of the implant device 1004 essentially consists of the cannula 1006, which has a cannula tip 1012 on its distal end, that is to say, on the side facing away from the hand-held portion 1010. In this region within the cannula 1006, the marker body 100 is generally in the preloaded state, not far before the outlet at the cannula tip 1012. The cannula 1006 can be formed, in particular, of a suitable metal.

[0134] The cannula 1006 has a length LKA, which can have a value, for example, between 25 mm and 200 mm, preferably between 50 mm and 150 mm. The length LKA of the cannula 1006 influences the range of action of the implant device 1004 in terms of the reachability of the tissue site to be marked in the patient's body. In the case of the use of calibration aids, for example stereotactic aids, longer cannulas are used.

[0135] The implant device 1004 has a hand-held portion 1010 and an implant portion 1008. The hand-held portion 1010 has a hand-held portion housing 1014, which can be made, for example, of a suitable plastic, and a sliding element 1016.

[0136] The sliding element 1016 is connected with the hand-held portion housing 1014, but can move in the axial direction of the cannula 1006 relative to the hand-held portion housing 1014. The sliding element 1016 can thus be moved on a straight, guided sliding path between a preloading position 1020 and an application position 1020.

[0137] This movement is transmitted by the sliding element 1016 to the distal region facing away from the hand-held portion 1010 by means of an application element 1018 connected with the sliding element 1016, which can be formed, for example, by a wire or a sufficiently stable plastic fiber. Thus, during the movement of the sliding element 1016 to the application position 1020, the preloaded marker body 100 can be applied at the distal end of the cannula 1006 by the sliding movement of the application element 1018 from the cannula 1006 at the tissue site to be marked.

[0138] This is achieved by moving the application element 1018 oriented coaxially with the cannula 1006 towards the cannula tip 1012 and thus pushing the preloaded marker body 100 out of the cannula 1006 past the cannula tip 1012.

[0139] exist Figure 10B The area shown in the diagram at the tip 1012 of the cannula Figure 10A Detail B, a detailed view of the implantation system 1000 in its preloaded state, shows the marker 100 in a compressed state, positioned behind the application element 1018 and in front of the cannula tip 1012 within the cannula 1006, as seen from the handheld portion 1010. Due to the pre-tightening of the marker, it remains in position within the cannula 1006 and does not fall out automatically. This characteristic eliminates the need for additional features or devices to secure the marker 100 within the cannula 1006.

[0140] Figure 10C And as Figure 10B Detail C shows a further detailed schematic diagram of the cannula 1006. In this view, the distal end of the application element 1018 within the cannula 1006 can be seen. Furthermore, the outer diameter DKA and inner diameter DKI of the cannula 1006 are identified.

[0141] The inner diameter DKI of the cannula 1006, together with the cannula length LKA, describes the size of the internal cavity formed by the cannula 1006 and simultaneously limits the maximum possible diameter DM of the marker 100 under compression, or, if necessary, the maximum possible diameter DK of at least one clamp 105, to ensure the continuity, or rather the mobility, of the marker 100 within the cannula 1006 during preloading and application. The inner diameter DKI has proven to be preferably less than 1.1 mm, and particularly preferably 1.0 mm.

[0142] The outer diameter DKA of the cannula 1006 describes the diameter of the outer cannula wall. Assuming a constant and as small a cannula wall thickness as possible, with the increase in the outer diameter BKA, the inner diameter DKI of the cannula 1006 and therefore the maximum possible outer diameter of the marker 100 to be implanted simultaneously increase. However, this increased outer diameter DKA also leads to a greater degree of invasiveness or damage to the skin and tissues during implantation.

[0143] A sufficiently small outer diameter DKA ensures the possibility of percutaneous implantation of the marker 100 without relying on an incision in the skin or anesthesia of related tissues at the entry site of the cannula 1006. The outer diameter DKA has proven to be preferably between 1 mm and 1.5 mm, particularly preferably 1.2 mm. Figure 11 The expanded marker body 100 is shown in a side view. Figure 12 The marker body 100 is shown in a separate view, in which one end of the marker body 100 can be seen.

[0144] The marker body 100 has a support structure composed of twenty-four individual pre-formed lines 1102. The support structure is constructed as a wire mesh 1104. The wire mesh 1104 is related to a reference...Figure 3 and Figure 4 The wire mesh 301 of the marker body 100 described is correspondingly formed by intersecting wires 1102. The wires of the wire mesh 1104 and 301 can be preformed elastic wires.

[0145] The wires 1102 extend helically around the longitudinal axis of the marker body 100 from a longitudinal end 1106 of the marker body 100 to an opposite longitudinal end 1108 of the marker body 100. The wires 1102 are guided on their way from one longitudinal end 1106 to the other longitudinal end 1108 of the marker body under and over the other wires of the carrier structure so that these wires form the wire mesh 1104. At the sites of the wire mesh 1104 where the wires 1102 are guided under or over the other wires 1102, intersection points 1110 are created. The wires 1102 of the wire mesh 1104 are not materially connected to each other at the intersection points 1110 but only in contact with each other. In an alternative embodiment not shown here, the wires can be welded to each other at the intersection points, as this is for example described in reference to Figure 3 and Figure 4 the marker body described.

[0146] The wires 1102 are guided diagonally from one longitudinal end 1106 to the other longitudinal end 1108 of the marker body 100 so that the marker body 100 is constricted in a central longitudinal section 1112.

[0147] Starting from the central longitudinal section 1112, the outer diameter of the marker body 100 continuously increases on both sides so that the marker body 100 has two conically widening longitudinal sections 1114, 1116. The outer diameter of the marker body 100 in the widening longitudinal sections 1114, 1116 is largest at the two longitudinal ends 1106, 1108 of the marker body 100, respectively.

[0148] The angle at which the marker body 100 is widened in the expanded state to the widening longitudinal sections 1114, 1116 can for example be 30° from the central axis and in particular be between 25° and 35°. The wire 1104 is formed from Nitinol.

[0149] At the free ends 1118 of the wires 1102 at the longitudinal ends 1106, 1108 of the marker body 100, every two adjacent wires 1102 are twisted into each other and welded. By the welding, a bead 1120 with a bead diameter D S is obtained, which is larger than the inner diameter DKI of the cannula and the outer diameter D AThe diameter difference between them. In this way, it is prevented that the marker, especially the solder ball of the marker, gets stuck between the distal section of the application element 1018 and the inner wall of the cannula. For this purpose, the distal end of the application element 1018 is also preferably configured with sharp edges, because rounded or chamfered edges may cause the marker to get stuck, thus preventing the marker from being implanted.

[0150] The marker 100 is configured such that a radial force of at least one Newton must be applied to the marker 100 in order to compress the marker to a diameter of less than 1.5 mm.

[0151] Marker 100 may have a sleeve, such as a Nitinol sleeve 1122, as shown in the reference. Figure 3 and Figure 4 The markers 100 and 100' are arranged in the central longitudinal section 1112 as described. The corresponding markers 100' are... Figure 17 It is drawn in the middle.

[0152] The size of the marker body 100 or 100' is determined by Figure 13 , 14 Figures 16 and 17 show, in conjunction with the gauge, the marker in the expanded state of marker 100. In the expanded state, the marker is approximately 6 mm to 7 mm long (see Figure 16). Figure 13 And has a maximum outer diameter of approximately 5 mm (see...) Figure 14 ).

[0153] Figure 15 It is an idealized three-dimensional diagram of marker 100. Figure 15 The illustration shows the basic structure; however, the illustration of the intersections and the freely interconnected longitudinal ends 1118 of line 1102 is idealized.

[0154] As by Figure 16 As can be seen, the marker 100 preferably has a length L, which is between 5 mm and 8 mm. The outer diameter D in the fully expanded state is between 4 mm and 6 mm. The constricted central longitudinal section 1112 has a diameter d of less than 1.5 mm. The diameter of each line 1102 is preferably slightly less than 0.1 mm. The weld bead 1120 at the free end 1118 of the line has a diameter greater than 0.1 mm, and this diameter is preferably at least 0.12 mm. Therefore, the marker 100 is suitable for use with the implantation device 1004, wherein the inner diameter DKI of the cannula and the outer diameter D of the application element are... A The maximum difference between them (also taking into account manufacturing tolerances) is -0.1 mm.

[0155] You can also from Figure 16As can be seen, the free longitudinal ends 1118 of wire 1102 are not only welded to each other but also twisted together. This ensures that when the wires are assembled together, the interconnected longitudinal ends do not separate from each other because the force generated by the pre-tightening in the tube does not act entirely on the welded parts, but is partially or completely absorbed by the twisting.

[0156] Unlike the idealized representation in the accompanying drawings, the longitudinal ends of each line 1102 are not all precisely located in the (separation) plane 1212 (see Figure 1212). Figure 19 and Figure 20 Instead of being arranged side-by-side, the markers are preferably slightly offset from this idealized plane in the longitudinal direction. This has the advantage that the marker 100 can be better compressed at its longitudinal end 1118 because the solder beads 1120 are not all arranged side-by-side, but are at least partially slightly offset from each other in the longitudinal direction of the marker 100.

[0157] In the fully expanded state of the marker, the widened longitudinal sections 1114 and 1116 of the marker are widened at an angle α relative to the longitudinal axis of the marker 100, which is preferably between 30° and 45°.

[0158] In the contracted central longitudinal section, the marker 100' has a sleeve 1122, which ensures that the marker 100' remains compressed in the central longitudinal section 1112 under any circumstances. The sleeve 1122 may be made of the same material as the individual wires 1102, i.e., preferably nitinol. However, preferably, the sleeve 1122 may also be made of a radiation-impermeable material such as gold. The sleeve 1122 is preferably welded to at least one wire of the wires 1102 by means of at least one solder point 1124 and is thus secured to prevent displacement. When the sleeve 1122 is provided, the wire ends need not be welded.

[0159] The size of the marker body 100' having the central sleeve 1122 is preferably approximately equivalent to the size of the marker body 100. Therefore, the length L2 of the marker body 100 is preferably between 5 mm and 10 mm. In the fully expanded state, the maximum diameter D2 of the marker body 100' is preferably between 4 mm and 6 mm. The central sleeve 1122 preferably has a diameter d2 of less than 2 mm, more preferably less than 1.8 mm, and particularly preferably less than 1.0 mm. The length h of the sleeve 1122 is preferably less than 2 mm; see [link to documentation]. Figure 17 .

[0160] Marker body 100 or marker body 100' is preferably formed from wire mesh 1200, as shown in Figure 18 As illustrated in the example. Figure 18 The wire mesh 1200 is shown as an interlaced conduit 1202 (see...) Figure 19) is shown, the wire tube is interwoven from 24 single wires. The wire mesh 1200, which forms the later marker body 100 or 100', is formed from 24 single wires 1102, which are nine times undercrossed or overcrossed between their longitudinal ends 1118 and pairwise at their longitudinal ends 1118 are twisted with each other and welded, so that the wire mesh 1200 has a weld bead 1120 at the longitudinal ends 1118 of the wires 1102, respectively. As Figure 18 It can be seen that the longitudinal ends 1118 of the mutually connected wires 1102 are not only welded to each other, but also twisted with each other.

[0161] In other embodiments, the marker body 100' can be made from a simple wire mesh 1200 without the twist 1206. In this embodiment, the wire ends do not have to be welded to each other, since the sleeve 1122 stably holds the braid.

[0162] To manufacture the wire mesh 1200 as shown in Figure 18 , first a wire tube 1202 as depicted in Figure 19 is manufactured. To manufacture the hose 1202, for example 24 individual wires 1102 are interwoven with each other, so that the wires are alternately overcrossed and undercrossed at the cross points 1110. In this way a cross point plane 1210 is generated, which extends transversely to the longitudinal direction of the hose 1202. After the individual wires 1102 have been crossed pairwise nine times, respectively, the individual wires are twisted with each other, thereby generating the twist 1206. The wire tube 1202 thus forms cross point planes 1210, which alternate with separation planes 1212, at which the respective wire mesh 1200 is separated from the wire tube 1202. In the example shown, every ninth cross point plane 1210 is followed by a separation plane 1212. In the separation plane, the wires 1102 are completely wound around each other pairwise twice, so that an included angle of 720° results. In other not shown embodiments, the included angle can also be only 360° or 540°.

[0163] Figure 20 The hose 1202 formed from the wires 1102 is shown, wherein the hose 1202 is separated at two separation sites 1214 by means of a laser beam. The separation sites 1214 are exactly in the separation planes 1212, that is to say where the twists 1206 are located. By means of the laser cut, the weld beads 1120 are generated, so that the then free pairwise mutually connected longitudinal ends 1118 of the wires 1102 are connected to each other by means of the twist and the laser welding.

[0164] Figure 21 and Figure 22 Again, a perspective view of the marker body 100 is shown.

[0165] The individual supports can have different diameters and can also have different cross-sectional shapes.Figure 23 a) to Figure 23 h) show various cross-sectional shapes. The support can for example be implemented as a solid wire in the shape of a circle and have a cross-section as shown in Figure 23 a). The support preferably consists of a hollow wire, i.e. of a type of small tube, which can have a cross-section as shown in Figure 23 b). Such a hollow wire has the advantage that it reflects sound well due to the difference in acoustic impedance between the wire wall material and the hollow interior. Figure 23 c) and Figure 23 d) show that the cross-sectional shape can also be quadrangular, in particular rectangular. Figure 23 e) and Figure 23 f) show a triangular cross-sectional shape of the support in the form of a solid material ( Figure 23 e)) or as a hollow support ( Figure 23 f)). Figure 23 g) and Figure 23 h) show that the support can in principle have an arbitrary prismatic cross-sectional shape, for example also a hexagon as shown in Figure 23 g) and Figure 23 h).

[0166] Since the marker 100 is preferably manufactured from a wire mesh, the wires typically simply touch at the intersection points. The intersection points can then look as shown, for example, in Figure 24 a). At such an intersection point, a fixed connection can be established between the two intersecting wires by welding. Figure 24 b) illustrates this by means of a weld 118 at the intersection point. If the supports are not interwoven, but simply laterally touch in an arc, as shown in Figure 24 c), a stable marker can also be manufactured in such a way that the touching supports are connected by welding, as this is shown in Figure 24 d). Here, too, a weld 118 is shown. Finally, the supports at the intersection points can also be twisted. Figure 24 e) shows a twisting, in which the supports are wound around each other at 360° and are subsequently connected to each other with a weld 118; see Figure 24 f). Instead of a 360° twisting, a 180° twisting is also sufficient. The resulting image then looks similar to Figure 24 c), except that the supports are hooked into each other.

[0167] Figure 25 a) to Figure 25 f) show that the supports can not only be connected by welding ( Figure 25 b)), by twisting ( Figure 25c) and Figure 25 e)) or by twisting and welding Figure 25 d) and Figure 25 f)) are connected. By welding the support 103 on its free longitudinal end 112 a weld bead 120 is created, which typically has a larger diameter than the individual support 103 or the wire forming the support 103.

[0168] Finally, Figure 26 and Figure 27 An implantation device 1004 for implanting the marker 100 is shown. As already explained in connection with Fig. 10, the implantation device 1004 has a hand-held portion 1010 and an implantation portion 1008. Part of the implantation portion 1008 is a cannula 1006, in which the marker 100 is first placed.

[0169] Figure 26 a) shows the implantation device 1004 with the sliding element 1016 and the application element 1018 in a pre-loaded position. The implantation system 1000 is thus ready for use and contains the marker 100 (not visible, as it is arranged in the cannula 1006). For protection against damage, a protective cover 1024 is provided. Figure 26 b) shows the implantation device 1004 with the sliding element 1016 and the application element 1018 in an application position, in which the marker is ejected in the application position.

[0170] The cannula tip 1012 on the distal end of the cannula 1006 is ground such that the cannula tip allows for a percutaneous implantation of the marker 1100 by piercing the cannula 1006 into the body tissue. The cannula 1006 is preferably made of stainless steel.

[0171] For ejecting the marker 100 from the cannula 1006, a movable application element 1018 is provided, such that it can be manipulated by the hand-held portion 1010 by means of the sliding element 1016.

[0172] By means of the implantation device, a marker of the type described herein can be implanted into soft tissue, such as breast tissue or axillary lymph nodes, after a previous lymph node biopsy for percutaneous marking.

[0173] Fields of application include marking of suspicious tissue, marking of lesions before or during chemotherapy, and marking of biopsy sites. It is also possible to mark the location of a resected tumor for better orientation of the radiation plan.

[0174] The marker is used in the context of surgery, for example as follows:

[0175] First, the cannula 1006 of the implantation device 1004 is inserted with its distal end 1012 into the desired implantation site in the body tissue and a marker body 100 is ejected from the distal end 1012 of the cannula 1006, which implants the marker body at the desired site.

[0176] The body tissue can then be examined using an imaging ultrasound method, in which the marked tissue is imaged ultrasonically. In the ultrasound image, the marker body can be identified due to the circular artifact 1300 or the X-shaped artifact 1302; see Figure 28 and Figure 29 .

[0177] List of reference signs

[0178] 100 marker body

[0179] 102, 104 widened longitudinal section

[0180] 103 support

[0181] 105 intersection

[0182] 106 central longitudinal section

[0183] 108 mesh

[0184] 110 longitudinal axis

[0185] 118 weld point

[0186] 120 weld bead

[0187] L1 length of the marker body

[0188] A1 maximum outer diameter of the marker body in the widened longitudinal section

[0189] l1 inner diameter of the marker body in the central longitudinal section

[0190] 301 wire mesh

[0191] 302, 304 widened longitudinal section

[0192] 306 central longitudinal section

[0193] 308 wire

[0194] 310 intersection

[0195] 312 free end of the wire

[0196] L2 length of the marker body

[0197] A2 maximum outer diameter of the marker body in the widened longitudinal section

[0198] 502 central longitudinal section

[0199] 504 longitudinal axis of the marker

[0200] 506, 508 widened longitudinal section

[0201] W1 angle of the helical load bearing structure

[0202] L3 length of the marker

[0203] A3 maximum outer diameter of the marker in the widened longitudinal section

[0204] 702, 704 widened longitudinal section

[0205] 706 central longitudinal section

[0206] L4 length of the marker

[0207] A4 maximum outer diameter of the marker in the widened longitudinal section

[0208] l2 inner diameter of the marker in the central longitudinal section

[0209] S1 providing a tubular wire mesh

[0210] S2 compressing the tubular wire mesh in a longitudinal direction of the tubular wire mesh

[0211] S3 partially rolling up the wire mesh

[0212] S4 collapsing the wire mesh in the central longitudinal section

[0213] DKI inner cannula diameter

[0214] DKA outer cannula diameter

[0215] BKA outer diameter

[0216] LKA cannula length

[0217] 1000 implant system

[0218] 1004 implant device

[0219] 1006 cannula

[0220] 1008 implant portion

[0221] 1010 handheld portion

[0222] 1012 cannula tip

[0223] 1014 handheld portion housing

[0224] 1016 sliding element

[0225] 1018 application element

[0226] 1020 pre-loaded position

[0227] 1022 application position

[0228] 1024 protective cover

[0229] 1102 thread

[0230] 1104 thread net

[0231] 1106, 1108 longitudinal end of marker body

[0232] 1110 intersection point

[0233] 1112 central longitudinal section

[0234] 1114, 1116 widened longitudinal section

[0235] 1118 longitudinal end of support

[0236] 1120 weld bead

[0237] 1122 sleeve

[0238] 1124 weld point

[0239] 1200 thread net

[0240] 1202 thread tube

[0241] 1206 intertwining

[0242] 1210 intersection point plane

[0243] 1212 separation plane

[0244] 1214 separation site

[0245] 1300 circular artifact

[0246] 1302 X-artifact

Claims

1. A method for manufacturing a marker body (100) for marking a body tissue, characterized in that, The method has the following steps: - providing a hose-like wire mesh (200; 301; 1104; 1200) having two longitudinal ends and being formed from 5 to 96 single wires (308; 1102) interwoven with one another, - pushing sleeves onto the hose-like wire mesh such that a section of the wire mesh is exposed between two sleeves and the two sleeves are oriented coaxially to one another, - moving the sleeves in the longitudinal direction of the hose-like wire mesh towards one another such that the wire mesh exposed between the sleeves is compressed in the longitudinal direction and widened in the radial direction, - constricting the wire mesh (200; 301; 1104; 1200) in a central longitudinal section (106; 306; 706; 1112) which is in the center of the wire mesh exposed between the sleeves such that the wire mesh (200; 301; 1104; 1200) widens in the longitudinal direction from the central longitudinal section (106; 306; 706; 1112) to both sides and forms two widened longitudinal sections (102, 104; 302, 304; 506, 508; 702, 704; 1114, 1116), - cutting the wire mesh (200; 301; 1104; 1200) perpendicular to the longitudinal direction of the wire mesh (200; 301; 1104; 1200) on both sides of the central longitudinal section (106; 306; 706; 1112) and removing the cut-out parts of the wire mesh (200; 301; 1104; 1200).

2. The method of claim 1, wherein, The method has the further steps: - connecting the free ends (312; 1118) of the wire mesh (200; 301; 1104; 1200) produced by the cutting, wherein the connection can be achieved by twisting before or after the cutting and / or the connection can be achieved by welding before, during or after the cutting.

3. The method of claim 1, wherein, The marker body: - is rotationally symmetrical with respect to a longitudinal axis (110) of the marker body, and - is formed from interconnected, elastic and pre-shaped metal supports (103), and - can assume a radially compressed state and a radially expanded state, wherein the marker body (100) is constricted in a central longitudinal section (106; 306; 706; 1112) in the expanded state of the marker body and widens in the longitudinal direction from the central longitudinal section (106; 306; 706; 1112) to both sides and has two widened longitudinal sections (102, 104; 302, 304; 506, 508; 702, 704; 1114, 1116) whose maximum outer diameters (A1; A2; A3; A4) are two to twenty times as large as the outer diameter of the central longitudinal section (106; 306; 706; 1112) in the expanded state of the marker body (100), the marker body (100) is constricted in a central longitudinal section (106; 306; 706; 1112) in the expanded state of the marker body and widens in the longitudinal direction from the central longitudinal section (106; 306; 706; 1112) to both sides and has two widened longitudinal sections (102, 104; 302, 304; 506, 508; 702, 704; 1114, 1116) whose maximum outer diameters (A1; A2; A3; A4) are two to twenty times as large as the outer diameter of the central longitudinal section (106; 306; 706; 1112) in the expanded state of the marker body (100), wherein the marker body (100) is formed by 5 to 96 supports (103) in circumferential direction at least in the widened longitudinal sections (102, 104; 302, 304; 506, 508; 702, 704; 1114, 1116), which extend essentially in longitudinal direction of the marker body (100) in compressed state of the marker body (100) and which are connected to one another in a force-locking, form-locking and / or material-locking manner.

4. The method of claim 3, wherein, The supports (103) of the marker body (100) consist of 5 to 96 wires (308; 1102), which extend from one longitudinal end to the other longitudinal end (1106, 1108) of the marker body (100) and cross one another multiple times and in this way form a grid-like load-bearing structure with a plurality of cross points (105; 310; 1110).

5. The method according to claim 3 or 4, characterized in that, The supports (103) of the marker body (100) are connected to one another in a material-locking manner at the cross points (105; 310; 1110).

6. The method according to claim 3 or 4, characterized in that, The supports (103) of the marker body (100) are twisted into one another on the longitudinal ends (1106, 1108) of the marker body.

7. The method according to claim 3 or 4, characterized in that, The supports (103) of the marker body (100) are connected to one another in pairs on the respective longitudinal ends (1106, 1108) of the marker body.

8. The method of claim 3 or 4, wherein, The outer diameter of the marker body (100) in expanded state of the marker body continuously increases in longitudinal direction from the central longitudinal section (106; 306; 706; 1112) towards the two longitudinal ends (1106, 1108) and the marker body (100) has the largest diameter of the marker body on both longitudinal ends (1106, 1108) of the marker body.

9. The method according to claim 3 or 4, characterized in that, The outer diameter of the marker body (100) in expanded state of the marker body firstly increases in longitudinal direction from the central longitudinal section (106; 306; 706; 1112) towards the two longitudinal ends (1106, 1108) and then decreases again towards the longitudinal ends (1106, 1108), so that the marker body (100) has the largest diameter of the marker body spaced apart by a distance from the respective longitudinal end (1106, 1108) of the marker body.

10. The method of claim 3 or 4, wherein, The supports (103) of the marker body (100) are made of a titanium alloy.

11. The method of claim 3 or 4, wherein, The central longitudinal section (106; 306; 706; 1112) is provided with a further sleeve (1122), which compresses the central longitudinal section (106; 306; 706; 1112) to a minimum diameter.

12. The method of claim 3 or 4, wherein, At least one support (103) is at least partially hollow.

13. The method of claim 3 or 4, wherein, The supports (103) of the marker body (100) are welded to one another in a material-locking manner at the cross points (105; 310; 1110).

14. The method of claim 3 or 4, wherein, The supports (103) of the marker body (100) are welded and / or twisted into one another in pairs on the respective longitudinal ends (1106, 1108) of the marker body.

15. The method of claim 3 or 4, wherein, The supports (103) of the marker body (100) are made of nitinol.

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