MARKER ELEMENT FOR MARKING TISSUE
20230000586 · 2023-01-05
Assignee
Inventors
Cpc classification
A61B17/3468
HUMAN NECESSITIES
A61B2090/3966
HUMAN NECESSITIES
International classification
A61B90/00
HUMAN NECESSITIES
Abstract
The invention relates to a marker element for marking body tissue. The marker element has an at least approximately rotation-symmetric geometry about a longitudinal axis, is formed by interlinked, elastic and preformed wire members and can assume a radially compressed and a radially expanded state. The wire members are interlinked at their respective ends, preferably in pairs.
Claims
1. A marking body for marking body tissue, said marking body having a longitudinal axis and being substantially rotationally symmetrical in relation to the longitudinal axis, wherein the marking body is formed by interconnected, elastic, preformed metal webs and is configured to transition between a radially compressed state and a radially expanded state, wherein, when the marking body is in the expanded state, the marking body is flared in a central longitudinal section and tapers from the central longitudinal section along the longitudinal axis toward each respective end face of the marking body, a maximum external diameter of the central longitudinal section being about two times to about twenty times greater than an external diameter of the end faces of the marking body, and wherein, when the marking body is in the compressed state, the metal webs forming the marking body extend substantially in a longitudinal direction of the marking body and at least one pair of the metal webs is interconnected in an interlocking and/or cohesive fashion at respective longitudinal ends of the metal webs.
2. The marking body as claimed in claim 1, wherein the marking body is formed by 5 to 100 webs, the webs extending along the longitudinal axis between the end faces of the marking body and crossing over one another multiple times to form a lattice-like support structure with a plurality of crossing points .
3. The marking body as claimed in claim 1, wherein the webs are wires, rods, or tubes.
4. The marking body as claimed in claim 2, wherein the webs of the marking body are cohesively interconnected at the crossing points.
5. The marking body as claimed in claim 2, wherein the webs of the marking body are twisted together at the crossing points.
6. The marking body as claimed in claim 1, wherein the webs of the marking body are all connected in pairs at respective longitudinal ends of the webs.
7. The marking body as claimed in claim 1, wherein, when the marking body is in the expanded state, an external diameter of the marking body decreases continuously from the central longitudinal section along the longitudinal axis toward each end face of the marking body such that the marking body has a minimum diameter at the end faces.
8. The marking body as claimed in claim 1, wherein the webs of the marking body are formed from a titanium alloy.
9. The marking body as claimed in claim 2, wherein the lattice-like support structure is formed by a braided wire mesh.
10. The marking body as claimed in claim 1, wherein the webs have a diameter of less than about 0.15 mm.
11. The marking body as claimed in claim 1, wherein at least one of the webs is at least partly coated with a material that differs from a material of the webs.
12. The marking body as claimed in claim 1, wherein the marking body comprises a membrane, which fills at least one region between two webs.
13. The marking body as claimed in claim 1, wherein the marking body is at least partially coated with a membrane on an outside of the marking body or on an inside of the marking body.
14. An implantation system having a marking body as claimed in claim 1 and an implantation apparatus with a cannula, the marking body being situated within the cannula and being configured to move out of the cannula by actuating the implantation apparatus.
15. The implantation system as claimed in claim 14, wherein the implantation system is configured for application within a vacuum biopsy unit with a cannula which has a lateral opening for driving out a marking body.
16. A method for producing a marking body for marking body tissue, the method including: forming a tubular braided wire mesh, which has two longitudinal ends and is formed by 5 to 100 braided individual wires, and compressing the braided wire mesh in a longitudinal direction to flare the braided wire mesh radially in a central longitudinal section of the braided wire mesh.
17. The method as claimed in claim 16, wherein forming the tubular braided wire mesh includes: braiding individual wires to form a tube such that the individual wires alternately cross over and under one another at crossing points, the crossing points being substantially arranged on crossing point planes which extend transversely to a longitudinal axis of the tube, and separating a section of the tube by laser cutting the individual wires at the crossing points in a separation plane, the separation plane corresponding to one of the crossing point planes.
18. The method as claimed in claim 17, further including: after separating the section of the tube, welding longitudinal ends of the individual wires together in pairs.
19. The method as claimed in claim 17, wherein the individual wires are twisted around one another at the crossing point planes, such that a pair of two individual wires is wrapped around one another through at least 180°.
20. The method as claimed in claim 19, wherein a pair of two individual wires is wrapped around one another through 360°, 540° or 720°.
Description
[0065] Further advantages, features and details of the invention arise from the following description of the preferred embodiments and the illustrating figures, in which:
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[0088] The marking body 100 comprises a support structure formed by a braided wire mesh 101. The wires 108 extend from one longitudinal end of the marking body 100 to its other longitudinal end. On the path from one longitudinal end to the other longitudinal end, the wires 108 cross other wires 108 and are braided in particular, that is to say each wire 108 is alternately guided first below and then above another wire 108 of the braided wire mesh 101. As a result, a lattice-like support structure with a multiplicity of crossing points 110 arises. In relation to the depicted representation in
[0089] The free ends 112 of the wires 108 located at the respective longitudinal ends 114, 116 of the marking body 100 are each twisted around and welded to one or more free ends of the further wires 108. Preferably, two wires 108 are always interconnected with the respective longitudinal ends 114, 116 by twisting and welding at a crossing point at the respective longitudinal end of the marking body 100.
[0090] At its longitudinal ends, the marking body 100 has two longitudinal sections 102, 104, from where the marking body 100 flares to a central longitudinal section 106. Consequently, the external diameter of the marking body 100 has a maximum in the central longitudinal section 106.
[0091] In the illustrated example, the braided wire mesh 101 comprises 24 wires which consist of nitinol and have a diameter of approximately 0.1 mm. In alternative embodiments of the marking body not shown here, the braided wire mesh comprises between 8 and 200 wires, for example 48 or 96 wires. In the embodiments not shown here, the marking bodies comprise braided wire meshes which are formed by wires with diameters ranging between 0.05 mm and 0.15 mm. Wires that consist of other metals, for example other titanium alloys other than nitinol can also be used. “Wires” made of plastic, for example PEEK or PLA, may also be provided in alternative embodiments of the marking body.
[0092] The individual webs may have different diameters and also different cross-sectional shapes.
[0093] Since the marking body 100 is preferably formed from a braided wire mesh, the wires typically contact each other once the crossing points. Then, a crossing point can have an appearance as depicted in exemplary fashion in
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[0095] The marking body 100 has a length LM of 6 mm; in alternative embodiments not shown here, this length may also range between 4 mm and 8 mm, however.
[0096] The maximum external diameter DMA of the marking body in the central longitudinal section 106 is 4 mm and can be between 3.5 mm and 10 mm in alternative embodiments not shown here.
[0097] To bring the marking body 100 into an elastically compressed state from the expanded state, a radial force of at least one newton must be exerted on the marking body 100.
[0098] In alternative embodiments not shown here, the self-expanding marking body 100 may have more wires and accordingly more crossing points, and so said marking body is comparatively stiffer. Accordingly, a comparatively greater radial force then is required to bring the marking body into an elastically compressed state. Likewise, the number of wires can be lower in alternative embodiments not shown here, in order to realize a marking body which already transitions into its elastically compressed state when a radial force of less than one newton is exerted.
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[0100] Initially, a tubular braided wire mesh is provided, the latter for example being able to comprise between 8 and 200 individual wires which are braided with one another and, as a consequence, cross at crossing points. These are 24 individual wires in the depicted example.
[0101] As may be gathered from
[0102] As can already be gathered from
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[0105] What can likewise be gathered from
[0106] Unlike what is depicted in idealized fashion in the
[0107] The marking body 100 is preferably formed from a braided wire mesh 200, as depicted in
[0108] To produce a braided wire mesh 200 as depicted in
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[0110] Following the separation of the braided wire mesh 200 from the wire tube 202, the former can be shaped into the marking body 100 by virtue of being compressed in the longitudinal direction. As a result, the braided wire mesh 200 bulges outward in a central longitudinal section while the longitudinal ends are constricted if the compression is for example implemented by means of two tools, each formed by a hollow hemisphere, moving toward one another. Depending on the tool shape, the marking body 100 can adopt shapes as depicted in longitudinal sections in
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[0112] A cannula tip 1012 at the distal end of the cannula 1006 has been whetted in such a way that it facilitates a percutaneous implantation of the marking body 100 by piercing the cannula 1006 into body tissue. The cannula 1006 preferably consists of stainless steel.
[0113] To eject the marking body 100 from the cannula 1006, provision is made of a displaceable driving-out element 1018, which can be actuated from the handle 1010 by means of the sliding element 1016.
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[0115] The implantation part 1008 of the implantation apparatus 1004 substantially consists of a cannula 1006 which has a cannula tip 1012 at its distal end, that is to say the end distant from the handle 1010. As a rule, the marking body 100 in the preloaded state is situated in this region within the cannula 1006, just inside the outlet at the cannula tip 1012. In particular, the cannula 1006 can be formed from a suitable metal.
[0116] The cannula 1006 has a length LKA which for example can adopt a value ranging between 25 mm and 200 mm, preferably between 50 mm and 150 mm. The length LKA of the cannula 1006 has an influence on the range of the implantation apparatus 1004 in respect of the reachability of tissue sites in the body of a patient to be labeled. The longer cannulas are used when adjustment aids are used, for example stereotaxis.
[0117] The implantation apparatus 1004 comprises a handle 1010 and an implantation part 1008. The handle 1010 comprises a handle housing 1014 and a sliding element 1016, which for example could be produced from a suitable plastic.
[0118] The sliding element 1016 is connected to the handle housing 1014 but is movable relative to the handle housing 1014 in the axial direction of the cannula 1006. Consequently, the sliding element 1016 can be moved along a straight, guided sliding path between a pre-loaded position 1020 and a driving-out position 1022.
[0119] This movement is transferred from the sliding element 1016 via a driving-out element 1018, which is connected to the sliding element 1016 and which can be formed for example by way of a wire or a sufficiently stable plastics fiber, to the distal region at a distance from the handle 1010. Consequently, when the sliding element 1016 is moved to the driving-out position 1022, the pre-loaded marking body 100 can be driven out of the cannula 1006 to the tissue site to be labeled at the distal end of the cannula 1006 by way of a sliding movement of the driving-out element 1018.
[0120] This is achieved by virtue of the driving-out element 1018 that is aligned coaxially with respect to the cannula 1006 being moved in the direction of the cannula tip 1012 and hence pushing the pre-loaded marking body 100 out of the cannula 1006 past the cannula tip 1012.
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[0123] Together with the cannula length LKA, the internal diameter DKI of the cannula 1006 describes the size of the internal cavity formed by the cannula 1006 and at the same time restricts the maximum possible diameter DM of the marking body 100 in the compressed state or, optionally, the maximum possible diameter DK of a clamp (should the marking body comprise the latter), in order to ensure an ability of the marking body 100 to pass through or move in the cannula 1006 during pre-loading and driving out. An internal diameter DKI of less than 1.1 mm, particularly preferably of 1.0 mm was found to be preferable.
[0124] The external diameter DKA of the cannula 1006 describes the diameter of the external cannula wall. Under the assumption of a constant cannula wall thickness that is as small as possible, the internal diameter DKI of the cannula 1006 simultaneously increases with increasing external diameter DKA, and hence there also is an increase in the maximum possible external diameter of a marking body 100 to be implanted. However, at the same time, an increasing external diameter DKA leads to a greater degree of invasiveness or injury to skin and tissue when carrying out the implantation.
[0125] A sufficiently small external diameter DKA ensures the option of a percutaneous implantation of the marking body 100 without having to resort to a stab incision of the skin at the entry site of the cannula 1006 or anesthetization of the relevant tissue. An external diameter DKA of between 1 mm and 1.5 mm, particularly preferably of 1.2 mm was found to be preferable.
[0126] By means the implantation apparatus, a marking body of the type presented here for percutaneous marking can be implanted into soft tissue, such as breast tissue or axillary lymph nodes following a lymph node biopsy.
[0127] The fields of application include the marking of suspicious tissue, the marking of lesions before or during chemotherapy, and the marking of a biopsy removal site. The location of a removed tumor may likewise be marked for improved orientation within the scope of radiation treatment planning.
[0128] By way of example, within the scope of an intervention, the marking body 100 is used as follows:
[0129] Initially, the marking body is implanted at a desired site by virtue of the distal end 1012 of the cannula 1006 of the implantation apparatus 1004 being pierced up to the desired implantation location in body tissue and a marking body 100 being ejected from the distal end 1012 of the cannula 1006.
[0130] Subsequently, the body tissue can be examined using an imaging ultrasound method for example, an ultrasound recording of the marked tissue being made. This is depicted in
[0131] In the case of sonography using medical ultrasound (1 MHz to 40 MHz, for example in the B mode [brightness modulation]; the mode in which two-dimensional brightness images are generated), the support structure of the marking body 100 causes incident ultrasound waves in the central longitudinal section of the marking body to strike a structure that is circular in cross section. What is obtained by matching the parameters of web diameter (or width and thickness), web number, web intensity and web material is that only some of the acoustic energy is reflected by the structure and the remaining part of the energy is transmitted, as depicted in exemplary fashion in
[0132] To make ultrasound recordings by means of sonography, use is made of a probe 300 which can transmit ultrasound 302 and can receive reflected ultrasound. By way of example, if the transmitted ultrasound strikes an object with a different acoustic impedance to the surrounding body tissue, the ultrasound is scattered and partly 304 reflected back to the probe 300; see
[0133] The characteristic circular shape of the image representation of the marking body in the ultrasound image allows the marking body to be automatically recognized and hence detected in an ultrasound recording, for example by means of an appropriately trained convolutional neural network (CNN).
[0134] The marking body 100 can be placed in a soft tissue without air inclusions (e.g., fatty tissue) and can be insonated with ultrasonic waves ranging between 1 MHz and 40 MHz. It then reflects only part of the ultrasonic power at the first side, which faces the ultrasound, and reflects a second part of the ultrasonic power at the second side, which is distant from the ultrasound, as a result of which the marking body has a circular representation in an ultrasound image within the scope of medical ultrasound imaging; see
[0135] Then, the marking body is detectable by means of an automatic or semiautomatic method, preferably by analyzing ultrasound data or by analyzing x-ray recordings or by analyzing MRI data.
[0136] To improve the visibility in the ultrasound image, or for other purposes, the marking body can be provided with a membrane 400. This can be realized in various ways; see
LIST OF REFERENCE SIGNS
[0137] 100 Marking body
[0138] 101 Braided wire mesh
[0139] 102, 104 Constricted longitudinal sections
[0140] 103 Webs
[0141] 105 Crossing points
[0142] 106 Central longitudinal section
[0143] 108 Wires
[0144] 110 Crossing points
[0145] 112 Free ends of the wires
[0146] 114, 116 Longitudinal ends of the marking body
[0147] 118 Weld spot
[0148] 120 Weld beads
[0149] 200 Braided wire mesh
[0150] 202 Wire tube
[0151] 208 Separation point
[0152] 212 (Separation) plane
[0153] 214 Crossing point plane
[0154] 216 Twist
[0155] 300 Ultrasound probe
[0156] 302 Transmitted ultrasound
[0157] 304 Reflected ultrasound
[0158] 310, 312 Image representation of a marking body in the ultrasound image
[0159] 400 Membrane
[0160] LM Length of the marking body
[0161] DMA Maximum external diameter of the marking body in the flared state
[0162] DKI Internal cannula diameter
[0163] DKA External cannula diameter
[0164] LKA Cannula length
[0165] 1000 Implantation system
[0166] 1004 Implantation apparatus
[0167] 1005 Clamp
[0168] 1006 Cannula
[0169] 1008 Implantation part
[0170] 1010 Handle
[0171] 1012 Cannula tip
[0172] 1014 Handle housing
[0173] 1016 Sliding element
[0174] 1018 Driving-out element
[0175] 1020 Pre-loaded position
[0176] 1022 Driving-out position
[0177] 1102 Wires
[0178] 1104 Braided wire mesh
[0179] 1106, 1108 Longitudinal ends of the marking body
[0180] 1110 Crossing points
[0181] 1112 Central longitudinal section
[0182] 1118 Free ends
[0183] 1120 Weld beads
[0184] 1122 Sleeve
[0185] 1124 Weld spot
[0186] 1200 Braided wire mesh
[0187] 1202 Wire tube
[0188] 1206 Twist
[0189] 1210 Crossing point planes
[0190] 1212 Separation plane
[0191] 1214 Separation points
[0192] 1300 Circular artifact
[0193] 1302 X-shaped artifact