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KR-102964121-B1 - Implantable marker

KR102964121B1KR 102964121 B1KR102964121 B1KR 102964121B1KR-102964121-B1

Abstract

The present invention relates to an implantable marker for marking a region of internal tissue of an animal or human, wherein the implantable marker is made of a biocompatible material and has at least one strand having a three-dimensional shape imprinted during a molding process, and the strand takes on the three-dimensional shape after an external mechanical restraint imposing a compressed three-dimensional shape on the strand is discontinued. The present invention is characterized in that the three-dimensional shape imprinted on the strand comprises two or more fixed strand eyelets, each of which is formed by one or more helical windings of the strand, and the shape and/or spatial relative position is different in the compressed three-dimensional shape imposed by the external mechanical restraint and in the three-dimensional shape imposed after the discontinuation of the mechanical restraint.

Inventors

  • 헤스케, 토마스

Assignees

  • 비아이피 바이오메드. 인스트루먼트& 프로덕트 게엠베하

Dates

Publication Date
20260512
Application Date
20200721
Priority Date
20190724

Claims (11)

  1. As an implantable marker (1) for marking an area of internal tissue of an animal or human, the implantable marker is It comprises at least one strand (2) having a three-dimensional shape made of a biocompatible material and imprinted by a molding process, wherein the strand (2) has an imprinted three-dimensional shape that is formed after a three-dimensional shape compressed by an external mechanical constraint is imposed on the strand and then the mechanical constraint is removed, and the three-dimensional shape imprinted on the strand (2) comprises at least three fixed strand eyelets (9, 10, 11) each formed by at least one helical winding of the strand (2) and integrally connected to one another by a strand section (8), wherein the shape and/or spatial position of the strand eyelets relative to one another is different in the compressed three-dimensional shape and in the imprinted three-dimensional shape, At least three fixed strand eyelets (9, 10, 11) are formed along the strand (2), and the eyelets of the strand (2) are arranged side by side in a compressed three-dimensional shape along a virtual linear axis (14) without overlapping each other within a hollow cannula (5) that applies external mechanical constraint. An implantable marker characterized by at least three fixed strand eyelets (9, 10, 11) being discharged from a hollow cannula (5) and adopting an arrangement in an imprinted spatial shape that is spatially different from being arranged continuously along a virtual linear axis (14) after the mechanical restraint is removed.
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  5. In Article 1, An implantable marker characterized in that the winding direction of one or more helical windings of the fixed strand eyelet is different between two strand eyelets arranged along the strand.
  6. In Article 1, One eyelet opening plane can be assigned to each fixed strand eyelet, and The eyelet opening plane of at least one fixed strand eyelet is oriented so as not to be parallel to the eyelet opening plane of at least one other strand eyelet in the imprinted three-dimensional shape after the interruption of the mechanical restraint, or An implantable marker characterized in that the eyelet opening planes of all strand eyelets are oriented parallel to the imprinted three-dimensional shape after the cessation of the mechanical restraint.
  7. In Article 1, An implantable marker characterized in that the biocompatible material of the strand is composed of a material that reflects ultrasound.
  8. In Article 1, An implantable marker characterized by the strand having a strand surface attached with a surface structure that reflects ultrasound in at least some area.
  9. In Article 1, An implantable marker characterized in that the strand, made of a biocompatible material, has at least one material having shape memory properties.
  10. In Article 1, An implantable marker characterized in that the strand made of a biocompatible material is a wire made of a metallic shape memory material of the NiTi ("Nitinol"), NiTiCu, CuZn, CuZnAl, or CuAlNi group.
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Description

Implantable marker The present invention relates to an implantable marker for marking a tissue region in the body of an animal or human, said marker being made of a biocompatible material and having a strand having a three-dimensional shape imprinted during a molding process, said strand taking on the three-dimensional shape after an external mechanical restraint imposing a compressed three-dimensional shape on said strand is discontinued. Common implantable markers are used to identify tumors in human or animal soft tissues. For example, after a breast biopsy, markers are often introduced into the tissue removal site by a cannula and, once they reach the desired location, are ejected distally from the cannula by a stylet. The markers placed in the body remain fixed and, with the aid of imaging methods—preferably ultrasound scans—provide the physician with the possibility to locate the tissue area to be treated and/or diagnosed and to observe it over an extended period. US 6,053,925 discloses a tissue marker for human tissue in which two wires made of shape memory metal are twisted together. The marker, which must be fixed as much as possible to the tissue area to be marked, is ring-shaped or coil-shaped for this purpose. US 2005/0059888 A1 discloses a marker that indicates the location of a biological absorber placed in the body. The marker consists of a material that can be detected by mammography, radiology, and ultrasound, for example, a wire attached to the absorber. US 2001/0023322 A1 discloses a cannula-type positioning unit for a marker that can be introduced into the body. The marker is composed of a shape memory metal wire, and the wire is deformed into a ring or coil shape at least at the end of the wire for fixed positioning in a tissue area to be marked after positioning in the body. Finally, EP 1 871 266 B1 discloses a ring-shaped general marker for human or animal tissue made of a preprogrammable material, preferably a nickel-titanium alloy, which becomes a preprogrammed ring shape when the lengthening is released after longitudinal elongation. All generally known markers, particularly the ring-shaped markers described above, are ultrasonic reflectors due to their material properties, but the known markers exhibit different intensities based on ultrasonic image capture depending on the direction of ultrasonic irradiation in which the ultrasound interacts with the marker. Generally, when a fan-shaped ultrasonic field strikes the aforementioned ring marker, which has a ring plane oriented orthogonally to the fan plane of the spreading ultrasound, only two point-shaped ultrasonic reflection signals reflecting the ring contour appear as the ultrasonic field rotates relative to the ring-shaped marker. On the other hand, when the fan-shaped ultrasonic field is oriented parallel to the ring plane, the possible reflection signals form a line in the ultrasonic image with a length corresponding to the diameter of the ring marker. Therefore, extensive experience is required to clearly recognize such markers, which are known in themselves and have dimensions ranging from a few millimeters within a biological tissue environment, both spatially and in a spatially resolved manner. The present invention is described below with reference to the drawings and embodiments, without limiting the comprehensive inventive concept. FIG. 1a illustrates a first embodiment of an implantable marker designed according to a solution of a compressed three-dimensional shape. FIGS. 1B and FIGS. 1C are a plan view and a side view of an implantable marker according to FIG. 1A having an imprinted three-dimensional shape. FIG. 2a illustrates a second embodiment of an implantable marker of a compressed three-dimensional shape. FIGS. 2B, FIGS. 2C, and FIGS. 2D illustrate different viewing angles for an implantable marker according to FIG. 2A with an imprinted three-dimensional shape. Figures 3a–3c illustrate different strand surface structures. FIGS. 1a–1c illustrate a first embodiment of an implantable marker designed according to a solution. FIGS. 1b and FIGS. 1c illustrate, respectively, a three-dimensionally imprinted marker (1) in a top view and a side view. The marker (1) is preferably manufactured from a circular wire (2) made of nitinol (NiTi) and has a three-dimensional shape with two fixed strands or wire eyelets (3, 4). The wire eyelets (3, 4) are each manufactured as a single-layer helical winding along the wire made of nitinol. The winding directions of the two wire eyelets (3, 4) are oriented oppositely. For the internal positioning of the implantable marker (1), the marker (1) is transformed into a compressed three-dimensional shape, linearly extended as shown in FIG. 1a, by external mechanical restraint. To this end, the nitinol wire (2) is extended in the wire length direction by a traction effect from the imprinted three-dimensional shape shown in FIG. 1b and FIG. 1c and introduced into a hollow cannula (5). The wi