Improved implantable marker and kit

Abstract

Implantable magnetic markers (seeds) offer a high degree of flexibility and convenience. Generally, larger markers are easier to position. Larger diameter markers may be used, but they should be much smaller than the average tumor size if they are to provide a useful degree of positioning. Implantable magnetic markers are provided with two or more permanent magnets linked by a mechanical connector to resiliently hold them in a first orientation when deployed and in a second orientation during implantation. This allows for the implantation of complex magnetic configurations while maintaining a simplified implantation method regardless of the number of magnetic elements used. The lateral range of the magnetic marker may be significantly reduced, allowing for the use of smaller needle diameters or the implantation of more smaller marker elements. Additionally, two or more magnetic elements may be aligned after implantation to increase the lateral range, which may increase detectability.

Description

[Technical Field]

[0001] Field The present disclosure relates to implantable markers, kits including one or more implantable markers, and detection units. The present disclosure further relates to methods of implanting implantable markers. [Background technology]

[0002] background During both invasive and non-invasive procedures and treatments, it is important for medical professionals to be able to accurately locate the area of ​​interest. Often, medical professionals rely on vision and manual manipulation to find and remember the area of ​​interest, often marking the external surface of the skin. In fact, imaging equipment such as x-ray and / or ultrasound may also be used to assist in location, relying on the ability to distinguish the area of ​​interest from surrounding tissue using imaging techniques.

[0003] Implantable markers (seeds) are also available. These offer greater flexibility and convenience, but still require significant effort by medical personnel to detect the alignment (positioning) of the marker. The magnetic field provided by the marker is determined by the magnetic properties of the material used and the dimensions of the marker; generally, the larger the marker, the easier it is to position. Larger diameter markers may be used, but if the marker is to provide a useful degree of positioning, it should be much smaller than the average tumor size. Summary of the Invention [Problem to be solved by the invention]

[0004] It is an object of the present invention to provide a marker of increased field strength without substantially reducing the tissue and treatment for which the marker can be used. [Means for solving the problem]

[0005] Overview According to a first aspect of the present disclosure, there is provided a marker for providing a detectable magnetic field, the marker comprising: a first magnetic element including a first permanent magnet with a north pole and a south pole; a second magnetic element including a second permanent magnet with a north pole and a south pole; and a rigid, bendable mechanical connector extending between a rigid attachment to the first magnetic element and a rigid attachment to the second magnetic element, the mechanical connector resiliently retaining a first orientation between a first pole of the first permanent magnet and a first pole of the second permanent magnet when arranged within human or animal tissue, the magnetic marker being surrounded by an embedded marker volume having a longitudinally embedded extent and a transversely embedded extent, the resiliently retaining a first orientation between the first pole of the first permanent magnet and the first pole of the second permanent magnet during implantation. and a rigid, flexible mechanical connector configured and arranged to elastically retain a second orientation between the first pole of the first permanent magnet and the first pole of the second permanent magnet, the mechanical connector being longitudinally disposed between the first pole of the first permanent magnet and the first pole of the second permanent magnet, the magnetic marker being surrounded by an embedding volume having a longitudinal embedding extent and a lateral embedding extent, whereby the lateral embedding extent is significantly larger than the lateral embedding extent and the longitudinal embedding extent is significantly smaller than the longitudinal embedding extent; the rigid, flexible mechanical connector, the first pole of the first permanent magnet being the same pole as the first pole of the second permanent magnet, and the mechanical connector being configured and arranged to overcome a repulsive magnetic force between the first pole of the first permanent magnet and the first pole of the second permanent magnet.

[0006] By using two or more magnetic elements, including permanent magnets, connected by a mechanical connector, when the marker is arranged within a person or animal, a different orientation angle between the two or more permanent magnets may be used after implantation compared to during (and / or before) implantation. Complex magnetic configurations may be implanted while maintaining a simplified implantation method regardless of the number of magnetic elements used. This allows the area of ​​the magnetic marker to be reduced for implantation, allowing for the use of smaller needle diameters (smaller needle gauges) or the use of more smaller marker elements. The marker may be configured and arranged to provide one or more predetermined second orientation angles using attractive and repulsive magnetic forces to assist in one or more aspects, such as during deployment, to fixate and / or increase the energy of the detectable signal.

[0007] The use of permanent magnets rather than soft magnetic materials allows detection without the need to expose the tissue region to high levels of energy. Additionally, systems that require energizing a soft magnet, the magnetic response to which generates a relatively high level of signal noise that must be detected; in contrast, permanent magnet detection only needs to distinguish against a generally low level of environmental background magnetism, and can be more accurate.

[0008] Additionally, two or more magnetic elements may be aligned after implantation to reduce their longitudinal extent by increasing their lateral extent, which may increase detectability.

[0009] According to a further aspect of the present disclosure, there is provided an implantable magnetic marker, wherein the first and / or second magnetic element includes a housing with a cavity, enclosing a permanent magnet within the cavity.

[0010] By providing an enclosure that encloses at least one permanent magnet, the properties of the permanent magnet, such as size, shape, material, finish, etc., may be optimized to a high degree independently from the properties of the magnetic element.

[0011] For example, the one or more housings may be constructed and arranged to substantially enclose the permanent magnet within its cavity. Because it is the exterior surface of the housing that is exposed to tissue, the one or more housings may be constructed and arranged to include one or more materials with a high degree of corrosion resistance and / or biocompatibility. In contrast, permanent magnets may optimize magnetic field strength without requiring a high degree of biocompatibility.

[0012] According to another aspect of the present disclosure, one or more housings may be constructed and arranged so that the alignment of north and / or south poles within said cavity can be changed during use.

[0013] The use of a housing allows the arrangement of magnetic poles to be configured and arranged to be the same as, similar to, or different from the physical arrangement of the magnetic elements, and may be permuted and / or rotated. In such embodiments, it may be advantageous to use weakly magnetic materials within the housing with a reduced, low, or insufficient degree of ferromagnetic properties when exposed to the magnetic field strengths generated by the permanent magnets used.

[0014] According to yet another aspect of the present disclosure, the mechanical connector is rigidly attached to an exterior surface of a housing included in the first and / or second magnetic element.

[0015] One or more attachments to the housing may be advantageous when using permanent magnetic materials where attachment (e.g., by gluing) to the permanent magnetic material may not be sufficiently stable for reliable, prescribed use and welding is not feasible or desirable.

[0016] According to still further aspects of the present disclosure, a mechanical connector extends between an end of a first magnetic element and an end of a second magnetic element having the same or opposite poles. The same poles may be held at a predetermined and / or controlled closer proximity. The opposite poles may also be held at a predetermined and / or controlled separation.

[0017] This may increase the outward magnetic field generated by the marker and therefore increase the detectability of the magnetic marker.

[0018] According to another aspect of the present disclosure, the implantable magnetic marker further includes one or more mechanical anchors configured and arranged to resist changes in position of the one or more magnetic elements when arranged within human or animal tissue.

[0019] The one or more mechanical anchors may be configured and arranged as tissue anchors to assist in anchoring the magnetic markers during implantation and / or to resist migration of the magnetic markers after implantation. It may be advantageous to resist movement and / or migration due to magnetic attractive and / or repulsive forces between proximal magnetic markers, between proximal magnetic elements, between the magnetic markers and any implantation channels, between the magnetic markers and any surgical instruments used before, during, or after implantation, or any combination thereof.

[0020] Optionally, the one or more mechanical anchors may be constructed and arranged to substantially retract prior to and / or during implantation, and to extend laterally after implantation.

[0021] Optionally, the one or more mechanical anchors may be constructed and arranged to extend laterally during implantation.

[0022] Applying force against the inner surface of the hole during implantation can significantly increase resistance to movement of the magnetic marker, which can be advantageous in preventing unwanted deployment of the implanted magnetic marker during implantation.

[0023] According to yet another aspect of the present disclosure, there is provided a third magnetic element including a third permanent magnet with a north pole and a south pole, and a second rigid, bendable mechanical connector extending between a rigid attachment to the third magnetic element and a rigid attachment to the second magnetic element, the second mechanical connector elastically retaining a third orientation between a first pole of the third permanent magnet and a second pole of the second permanent magnet when arranged within human or animal tissue, wherein the magnetic marker is surrounded by an embedded marker volume having a longitudinally embedded extent and a transversely embedded extent, and during implantation, the second mechanical connector elastically retaining a third orientation between a first pole of the third permanent magnet and a second pole of the second permanent magnet. The magnetic marker further includes a second rigid, bendable mechanical connector configured and arranged to elastically hold the magnetic marker in a fourth orientation between the first pole of the third permanent magnet and the second pole of the second permanent magnet, wherein the mechanical connector is longitudinally disposed between the first pole of the third permanent magnet and the second pole of the second permanent magnet, and the magnetic marker is surrounded by an embedding volume having a longitudinal embedding extent and a lateral embedding extent, wherein the first pole of the third permanent magnet is the same pole as the second pole of the second permanent magnet, and the second mechanical connector is configured and arranged to overcome the repulsive magnetic force between the first pole of the third permanent magnet and the second pole of the second permanent magnet.

[0024] Advantageously, multiple magnetic elements may be embedded in controlled configurations, which in some configurations further increases the combined magnetic field strength available for detection.

[0025] Optionally, the first and third magnetic elements may have a longitudinal extent that is substantially less than the longitudinal extent of the second magnetic element.

[0026] In embodiments where the magnetic marker includes three or more magnetic elements, the magnetic connector may be configured to allow the two outer magnetic elements to be folded toward the central magnetic element, which may result in an overall reduction in the longitudinal embedded range of the magnetic marker with a smaller increase in maximum lateral embedded range.

[0027] Optionally, the ends of the third magnetic element and the first magnetic element having opposite polarities may be held at a predetermined and / or controlled closer proximity.

[0028] This may result in a smaller increase in maximum lateral implant range, and in addition, using the attraction due to the opposite polarity of the reduced range magnetic elements may reduce the risk of incorrect or incomplete deployment.

[0029] According to yet a further aspect of the present disclosure, a kit is provided for locating a tissue region of interest, including one or more implantable markers including one or more permanent magnets, and a magnetic field marker probe having one or more magnetic sensors configured and arranged to measure magnetic fields generated by the one or more permanent magnets after being placed in human or animal tissue.

[0030] According to a further aspect of the present disclosure, a kit of parts for implanting a magnetic marker is provided, comprising one or more implantable markers surrounded by one or more marker embedding volumes and comprising one or more permanent magnets, and an embedding channel having a hole substantially equal to or larger than the one or more marker embedding volumes.

[0031] Optionally, the buried channel may include one or more weakly magnetic materials.

[0032] According to another aspect of the present disclosure, there is provided a method for implanting an implantable magnetic marker, the magnetic marker including a first magnetic element including a first permanent magnet with a north pole and a south pole, a second magnetic element including a second permanent magnet with a north pole and a south pole, and a rigid, bendable mechanical connector extending between a rigid attachment to the first magnetic element and a rigid attachment to the second magnetic element, the method including, after implantation, elastically retaining a first orientation between a first pole of the first permanent magnet and a first pole of the second permanent magnet when arranged in human or animal tissue, the magnetic marker being surrounded by an implanted marker volume having a longitudinally embedded extent and a transversely embedded extent; and elastically retaining a second orientation between a first pole of the stone and a first pole of a second permanent magnet, wherein a mechanical connector is longitudinally disposed between the first pole of the first permanent magnet and the first pole of the second permanent magnet, and wherein the magnetic marker is surrounded by an embedding volume having a longitudinal embedding range and a lateral embedding range, whereby the lateral embedding range is significantly larger than the lateral embedding range and the longitudinal embedding range is significantly smaller than the longitudinal embedding range, and the first pole of the first permanent magnet is the same pole as the first pole of the second permanent magnet, and the mechanical connector is configured and arranged to overcome a repulsive magnetic force between the first pole of the first permanent magnet and the first pole of the second permanent magnet.

[0033] According to another aspect of the present disclosure, a method is provided further comprising, during implantation, moving the magnetic marker through an implantation channel, the implantation channel having a lateral pore dimension greater than or equal to the lateral implantation extent of the magnetic marker.

[0034] Additionally or alternatively, the embedding channel may have a longitudinal bore dimension that is equal to or greater than the longitudinal embedding extent of the magnetic marker.

[0035] Additionally or alternatively, the embedding channel may have a pore size equal to or greater than the embedding capacity of the magnetic marker.

[0036] This means that the degree to which movement of the marker through the hole is resisted may be predetermined and / or controlled.

[0037] According to yet another aspect of the present disclosure, a method is provided that includes resiliently holding a north pole of a first permanent magnet and a north pole or a south pole of a second permanent magnet proximally, more proximally, very proximally, in contact, or any combination thereof during and / or after implantation.

[0038] Additionally or alternatively, methods are provided that include resiliently holding the south pole of the first permanent magnet and the north or south pole of the second permanent magnet proximal, more proximal, very proximal, touching, or any combination thereof during and / or after implantation.

[0039] This may increase the outward magnetic field generated by the marker and therefore increase the detectability of the magnetic marker.

[0040] According to yet another aspect of the present disclosure, a method is provided that includes folding a first magnetic element toward a second magnetic element and / or folding the second magnetic element toward the first magnetic element during and / or after implantation, whereby a longitudinally embedded extent is reduced compared to a longitudinally embedded extent.

[0041] Additionally or alternatively, methods are provided that include folding the first magnetic element toward the second magnetic element and / or folding the second magnetic element toward the first magnetic element during and / or after implantation, whereby the laterally embedded range is increased compared to the lateral embedded range.

[0042] The mechanical connector may be configured to allow the two magnetic elements to fold towards each other, which may reduce the overall longitudinal embedded extent of the magnetic marker.

[0043] Alternatively, the magnetic marker may further include a further permanent magnet having a north pole and a south pole, and a further rigid, bendable mechanical connector extending between the rigid attachment to the further magnetic element and the rigid attachment to the second magnetic element, the further mechanical connector configured and arranged to resiliently maintain a further first orientation between a first pole of the further permanent magnet and a second pole of the second permanent magnet when disposed within human or animal tissue, and to resiliently maintain a further second orientation between the first pole of the further permanent magnet and the second pole of the second permanent magnet during implantation, the second pole of the third permanent magnet is the same pole as the second pole of the third permanent magnet, and the second mechanical connector is configured and arranged to overcome a repulsive magnetic force between the first pole of the third permanent magnet and the second pole of the second permanent magnet, and the method further includes folding the first magnetic element toward the second magnetic element and / or folding the second magnetic element toward the first magnetic element during and / or after implantation, and folding the further magnetic element toward the second magnetic element and / or folding the second magnetic element toward the further magnetic element during and / or after implantation, whereby the longitudinal embedded extent is reduced compared to the longitudinal embedded extent.

[0044] Additionally or alternatively, the horizontally embedded range may be increased relative to the horizontally embedded range.

[0045] In embodiments where the magnetic marker includes three or more magnetic elements, the mechanical connector may be configured to allow two outer magnetic elements to be folded toward the central magnetic element, which may reduce the overall longitudinal embedded range of the magnetic marker with a smaller increase in maximum lateral embedded range.

[0046] According to still further aspects of the present disclosure, there is provided a method wherein the implantable magnetic marker further comprises one or more mechanical anchors, the method further comprising, during and / or after implantation, the one or more mechanical anchors being capable of adopting a first shape and / or a first orientation relative to the magnetic marker, whereby change in position of the one or more magnetic elements is significantly resisted within human or animal tissue.

[0047] Optionally, the method may further include allowing the one or more mechanical anchors to adopt a second shape and / or a second orientation relative to the magnetic marker during implantation, thereby exerting a force against the inner surface of the implantation channel to significantly resist movement of the magnetic marker through the implantation channel.

[0048] This may be advantageous to prevent unwanted deployment of the implanted magnetic markers during implantation.

[0049] BRIEF DESCRIPTION OF THE DRAWINGS The features and advantages of some embodiments of the present invention, and the manner in which they are accomplished, will become readily apparent from consideration of the following detailed description of the invention in conjunction with the accompanying drawings, which illustrate preferred exemplary embodiments and which are not necessarily drawn to scale. [Brief explanation of the drawings]

[0050] [Figure 1] 1 depicts a longitudinal section through a magnetic probe for detecting magnetic markers according to the present invention. [Figure 2A] 1A-1D depict plan views of a first embodiment of an implantable magnetic marker in different orientations before, during, and after implantation. [Figure 2B] 1 depicts a longitudinal cross section of a first embodiment of an implantable magnetic marker within an implanted channel. [Figure 2C] 1A-1D depict plan views of a first embodiment of an implantable magnetic marker in different orientations before, during, and after implantation. [Figure 2D]1A-1D depict plan views of a first embodiment of an implantable magnetic marker in different orientations before, during, and after implantation. [Figures 2E-2F] 1 depicts a plan view and a cross section of a modified first embodiment. [Figure 3A-3C] 3 illustrates a schematic cross-section of how the magnetic marker depicted in FIG. 2 may be embedded. [Figures 4A-4C] 1 depicts a plan view of a further embodiment of an implantable magnetic marker. [Figures 5A-5E] 5A and 5B are schematic cross-sectional views of how the magnetic markers depicted in FIG. 4 may be embedded. [Figures 6A-6C] 1 depicts a plan view of a further embodiment of an implantable magnetic marker. [Figures 7A-7B] A cross section is drawn through the permanent magnet and any housing for the permanent magnet. [Figures 8A-8D] 10 depicts a plan view of a further embodiment of an implantable magnetic marker including one or more mechanical (tissue) anchors. [Figures 9A-9C] 9A and 9B are schematic cross-sectional views of how the magnetic markers depicted in FIG. 8 may be embedded. [Figures 10A-10C] 1 depicts a plan view of a further embodiment of an implantable magnetic marker. [Figures 11A-11C] 1 depicts a plan view of a further embodiment of an implantable magnetic marker. [Figures 12A-12C] 12A and 12B are schematic cross-sectional views of how the magnetic markers depicted in FIG. 11 may be embedded. [Figures 13A-13I] 10 depicts several schematic plan views of further embodiments of implantable magnetic markers with one or more further examples of mechanical anchors. DETAILED DESCRIPTION OF THE INVENTION

[0051] Detailed Description In the following detailed description, numerous non-limiting details are provided to aid in understanding the present disclosure. It will be apparent to those skilled in the art that the computer processing components of the method may be implemented in any type of standalone system or client-server compatible system containing any type of client, network, server, and database elements.

[0052] 1 depicts a longitudinal section through a magnetic field marker probe 100 for detecting the alignment (positioning) of an implantable marker 200, in accordance with the present invention. As depicted, the magnetic marker 200 is implanted below the outer surface of the skin 300, which may be several millimeters or centimeters below the outer surface of the skin, to mark an area of ​​interest. This may also be referred to as depth. The marker 200 is configured to generate a magnetic field in use, which may include, for example, a magnetic dipole.

[0053] The marker 200 may be implanted by any convenient method, such as by injection. The injection may be, for example, into soft tissue or an organ, or delivered to the lung bronchi via a bronchoscope or to the colon via a colonoscope. The implantation method may depend, for example, on the depth required, the sequence of procedures being performed, the size of the region of interest, the location of the region of interest, the type of tissue within the region, and the type of tissue surrounding the region. The marker 200 may be implanted immediately prior to or sometime before detection.

[0054] The probe 100 includes one or more magnetic sensors 110, typically proximal to a distal end 160 of the probe 100. The one or more magnetic sensors 110 are configured to measure at least a vector (Bx, By, Bz) of the local magnetic field, which may include background measurements and the magnetic field generated by the marker 200 when the probe 100 is more proximal. The magnetic probe may extend along a longitudinal axis 150 of the probe.

[0055] The one or more magnetic sensors 110 may be of any suitable type, such as magnetometers, fluxgate sensors, geomagnetic sensors, Lorentz force digital MEMS, magneto-inductive sensors, magnetoresistive sensors, Hall sensors, magnetic tunnel junctions, and any combination thereof. Many IC packages are available that are compact and contain three-axis detection, so a "multi-axis" solution may be provided with a simple PCB design, preferably with a smaller probe diameter.

[0056] Distal end 160 may be configured and arranged to be aligned near an outer surface of skin 300. Additionally or alternatively, distal end 160 may be configured and arranged to be aligned near an outer surface of skin 300. - contacting the outer surface of the skin 300; - inserted through the outer surface of the skin 300; - inserted into a body cavity through a natural orifice, - inserted into a body cavity through a surgical incision or wound; or - may be constructed and arranged to be any combination thereof.

[0057] The distal end 160 may be arranged away from the outer surface of the skin 300, a spacer may be used to maintain a fixed distance, or the distance may be zero if the probe 100 is further configured and arranged to contact the outer surface of the skin 300. The probe 100 may be further configured and arranged to be pressed against the outer surface of the skin 300 to create a depression that may further reduce the distance between the distal end 160 of the probe 100 and the marker 200. Generally, the smaller the distance between the probe 100 and the marker, the greater the amplitude of any signal measured. For some procedures, the probe 100 may be further configured and arranged to be inserted through the outer surface of the skin 300 and / or into a body cavity to further reduce the distance between the probe 100 and the marker 200. This may be, for example, through a surgical incision or through a natural orifice.

[0058] The magnetic probe 100 may also be constructed and arranged to detect the alignment (positioning) of one or more implanted magnetic elements. Typically, such conventional elements include magnetic dipoles, - Diameter 1.45 mm, length 2.19 mm, and residual magnetic field (Br) 1.43 T (Neodymium N52), or - Diameter 1.75 mm, length 5 mm, and residual magnetic field (Br) 1.43 T (Neodymium N52), or - Approximately cylindrical with a diameter of 1.45 mm and a length of 4.7 mm (also neodymium N52).

[0059] These examples may be implanted using a 14G needle with an inner diameter (hole) of 1.8 mm / outer diameter of 2.1 mm.

[0060] The detectability of a magnetic element depends on parameters such as the capacitance of the magnetic material and the magnetic material properties, for example higher grade neodymium may increase detectability, but these may be more expensive.

[0061] The inventors have considered ways in which greater volumes of magnetic material can be used. One of the perspectives on which the present invention is based is that using larger and / or multiple magnetic elements can be disadvantageous, i.e. Longer markers may be used, but if the marker is to provide an effective degree of localization, it should preferably be much shorter than the average tumor size. Larger diameter markers may require larger needle gauges for implantation, which limits the types of tissue and treatments that can be used. For example, not all tumors are suitable for receiving large gauge needles. - Multiple magnetic elements may be embedded together. However, the attraction of opposite poles and repulsion of like poles means that they tend to align with each other in largely unpredictable ways. In many cases, such multiple magnetic elements may naturally and / or physically align in ways that reduce outward magnetic field lines, which may impair detectability.

[0062] Markers containing two or more bonded elements are known from U.S. Pat. No. 10,595,957, which discloses a marker containing multiple soft magnetic elements. U.S. Pat. No. 10,595,957 considers that an ideal magnetic marker is one that magnetizes in the presence of a magnetic field and does not exhibit permanent magnetic remanence (retained magnetization) when the magnetic field is removed, or in other words, one that is soft magnetic, i.e., formed from a soft magnetic material or behaves as if it were soft magnetic. The magnetic field (magnetization) induced in the material is detected by a probe. Multifaceting also provides excellent ultrasonic response. U.S. Pat. No. 10,595,957 considers that permanent magnets are generally unsuitable for bonding because they can attract or be attracted by other ferromagnetic objects and typically have very low magnetic susceptibility.

[0063] Indeed, the magnetic markers in this disclosure have complex 3D volumes that can vary significantly before, during, and / or after implantation, and optimization of two or more degrees of freedom may be required to achieve sufficient evolution of the desired magnetic configuration.

[0064] However, to explain the principles behind the embodiments, the figures in this disclosure primarily illustrate 2D examples, which appear to have cross sections that are substantially symmetric about a central longitudinal plane.

[0065] The inventors have recognized that it would be highly advantageous to use an implantable magnetic marker that includes two or more permanent magnetic elements joined together by one or more mechanical connectors. Such a magnetic marker 200 is depicted generally in Figures 2A, 2B, 2C(i), 2C(ii), 2D(i), and 2D(ii). More particularly, Figures 2C(i), 2C(ii), 2D(i), and 2D(ii) depict schematic plan views of magnetic marker 200 after implantation.

[0066] 2A depicts a schematic plan view of a magnetic marker 200 prior to implantation. The magnetic marker 200 includes: a first magnetic element 210, comprising a permanent magnet, the permanent magnet having a first north pole and a first south pole (not depicted in FIG. 2); a second magnetic element 211, comprising a permanent magnet, the permanent magnet having a second north pole and a second south pole (not depicted in FIG. 2); a magnetic connector 250, extending between the first magnetic element 210 and the second magnetic element 211;

[0067] Prior to implantation, the magnetic marker 200 has a marker volume with a longitudinal extent 200a, a first lateral extent 200b, and a second lateral extent (not depicted). The extents 200a, 200b are determined by the orientation of all magnetic elements 210, 211, all magnetic connectors 250, and the relationship between the first magnetic element 210 and the second magnetic element 211. The lateral extent 200b may vary at different positions along the longitudinal extent 200a. The longitudinal extent 200a may vary at different positions along the lateral extent 200b.

[0068] 2B depicts a longitudinal section through marker 200 and through a suitable bore-embedded channel 400 with longitudinal bore area 400a, first transverse bore area 400b, and second transverse bore area (not depicted). The sharp point on the right side of buried channel 400 is an opening from which the magnetic elements emerge in the following order: first magnetic element 210, magnetic connector 250, and then second magnetic element 211.

[0069] The embedded channel 400 may be included in an embedding tool.

[0070] To allow for easy passage through the holes 400b, the volume boundaries of the magnetic marker 200 are preferably an embedding volume substantially less than or equal to the hole dimensions 400a, 400b of the embedding channel 400. During embedding, the boundaries of the embedding channel 400 (typically the walls of the channel 400) limit the maximum marker embedding volume; otherwise, the magnetic marker 200 may not easily move through the channel. Depending on the configuration and placement, the magnetic marker 200 may exert a force on the boundaries that can affect resistance to movement through the embedding holes 400b.

[0071] Thus, the maximum marker embedding capacity would be considered to have a longitudinal embedding area substantially equal to longitudinal hole area 400a, a first lateral area substantially equal to first lateral hole area 400b, and a second lateral area substantially equal to second lateral hole area (not depicted). Alternatively or additionally, longitudinal hole area 400a may be greater than longitudinal marker embedding area 200a. Alternatively or additionally, first lateral hole area 400b may be greater than first lateral marker embedding area 200b. Alternatively or additionally, second lateral hole area may be greater than second lateral marker embedding area.

[0072] Holes of any shape may be considered, including spherical embedding volumes with a diameter equal to the maximum of the longitudinal embedding area 400a, the first lateral embedding area 400b, or the second lateral embedding area. Similarly, rectangular tank embedding volumes may be considered with a height equal to the first lateral embedding area 400b, a width equal to the second lateral embedding area (not depicted), and a length equal to the longitudinal embedding area 400a. Similarly, capsule embedding volumes may be considered with a diameter equal to the lateral embedding area 400b and a length equal to the longitudinal embedding area 400a (or equal to the longitudinal embedding area 400a minus the lateral extent 400b). Similarly, elliptical embedding volumes or truncated conical embedding volumes may be used.

[0073] It is particularly convenient to consider a substantially cylindrical bore 400b, such as a hollow injection needle. A cylindrical implantation volume may then be considered, with a length equal to the longitudinal implantation extent 400a and an inner diameter equal to the larger of the first lateral implantation extent 400b and the second lateral implantation extent (not depicted).

[0074] 2C(i) and 2C(ii) depict schematic plan views of the magnetic marker 200 after implantation, with the mechanical connector 250 resiliently holding the first magnetic element 210 and the second magnetic element 211 in a first orientation and a different orientation. The different orientation may be in any direction, and indeed the first magnetic element 210 and the second magnetic element 211 may be aligned along tilted longitudinal axes, the axes not necessarily intersecting.

[0075] 2C(i), the first magnetic element 210 is arranged along a first central longitudinal plane 270, and the second magnetic element 211 is arranged along a second central longitudinal plane 271. The first central longitudinal plane 270 and the second central longitudinal plane 271 intersect at an angle 280 on a side of the mechanical connector 250.

[0076] In other words, after implantation, the first magnetic element 210 folds back towards the second magnetic element 211 to form a generally V-shaped magnetic marker 200 when viewed along the first central longitudinal plane 270 and the second central longitudinal plane 271. In FIG. 2C(i), the longitudinal direction of the marker 200 is depicted horizontally and the first lateral direction is depicted vertically. The marker 200 is - a maximum longitudinal extent 200d from the end of the magnetic elements 210, 211 to the outer edge of the mechanical connector 250; - has an embedded marker with a maximum first lateral extent 200e at the end of the greatest lateral separation between the outer edge of the magnetic element 210 and the outer edge of the magnetic element 211;

[0077] 2C(ii) depicts a side end view of the mechanical connector 250. The first lateral direction is depicted vertically and the second lateral direction is depicted horizontally. The embedded capacitance of the marker 200 is: - further having a maximum second lateral extent 200f between the outer edge of the magnetic element 210 and the outer edge of the magnetic element 211. In this example, the maximum second lateral extent 200f is approximately the lateral extent of the first magnetic element 210 or the second magnetic element 211.

[0078] So in summary, the magnetic marker 200 may be considered to be surrounded by an embedded marker volume having a longitudinally embedded area 200d, a first laterally embedded area 200e, and a second laterally embedded area 200f.

[0079] By arranging the first magnetic element 210 and the second magnetic element 211 in orientation 280 relative to each other after deployment, the laterally embedded range 200ef is significantly larger than the laterally embedded range 400b, and the longitudinally embedded range 200d is significantly smaller than the longitudinal embedded range 400a.

[0080] For the purposes of this disclosure, the following are considered important: - an increase in the transverse embedded range 200ef of at least 0.1 times the transverse range of the electromagnetic elements 210, 211. Increases of 0.125, 0.25, 0.5, 0.75 and 1, 2x, 3x and 4x are considered increasingly significant; A reduction in the longitudinal embedded extent 200d of at least 0.1 times the lateral extent of the electromagnetic elements 210, 211. Reductions of 0.125, 0.25, 0.5, 0.75, 1x, 2x, 3x and 4x are considered increasingly significant.

[0081] This may increase the volume of magnetic material present by providing multiple smaller permanent magnetic elements 210, 211 in a predetermined and / or controlled orientation and / or proximity to one another. In other words, multiple magnetic elements 210, 211 may be aligned to reduce the embedded longitudinal extent 200d by increasing one or more embedded lateral extents 200ef. Using two or more magnetic elements 210, 211 in proximity may provide the same magnetic field strength as using multiple smaller permanent magnets 210, 211 of larger dimensions. Smaller magnetic elements 210, 211 are generally easier to embed because they may use smaller holes in the embedding channel 400.

[0082] Additionally, the use of a permanent magnet rather than a soft magnetic material allows detection without the need to expose an area of ​​tissue to high levels of energy. Additionally, systems that require energizing a soft magnet generate relatively high levels of signal noise against which the magnetic response must be detected; in contrast, permanent magnet detection generally only needs to distinguish against low levels of environmental background magnetism and can be more accurate.

[0083] Any shape of embedded volume may be considered, including a spherical embedded volume having a diameter equal to the maximum of longitudinal embedded area 200d, first lateral embedded area 200e, or second lateral embedded area 200f. Similarly, a rectangular tank embedded volume may be considered, having a height equal to first lateral embedded area 200e, a width equal to second lateral embedded area 200f, and a length equal to longitudinal embedded area 200d. Similarly, a capsule embedded volume may be considered, having a diameter equal to first or second lateral embedded area 200ef and a length equal to longitudinal embedded area 200d (or equal to longitudinal embedded area 200d minus first or second lateral embedded area 200ef). Similarly, an elliptical embedded volume or a frustoconical embedded volume may be used.

[0084] It is particularly convenient to consider a cylindrical implanted volume having a length equal to the longitudinally implanted area 200d and a diameter equal to the larger of the first laterally implanted area 200e and the second laterally implanted area 200f.

[0085] It may be advantageous to use similar or identical volume definitions for the embedding volume and the embedded volume.

[0086] Examples of different embedded orientations 280 are depicted in Figures 2D(i) and 2D(ii), which are the same as Figures 2C(i) and 2C(ii), except for the following: the first longitudinal plane 270 and the second longitudinal plane 271 are substantially parallel instead of intersecting at an orientation angle 280; the first lateral extent 200e between the outer edge of the magnetic element 210 and the outer edge of the magnetic element 211 is substantially the same on both ends of the magnetic elements 210, 211;

[0087] In some configurations, this may provide the most compact arrangement of the magnetic elements 210, 211, significantly reducing the first lateral extent 200e.

[0088] For example, magnetic marker 200 may be configured and arranged under ideal circumstances to be fully deployed as depicted in Figures 2D(i) and (ii), but when actually arranged within human or animal tissue, magnetic elements 210, 211 may not be fully contiguous at both ends, resulting in the angular separation depicted in Figures 2C(i) and (ii), where one end of magnetic elements 210, 211 is closer to each other than the other.

[0089] Alternatively, the magnetic marker 200 may be configured and positioned under ideal circumstances to fully deploy, as depicted in Figures 2C(i) and (ii), for example, such a V-shape may provide more resistance to movement in one direction within tissue than another.

[0090] For example, it may be advantageous for the first longitudinal plane 270 and the second longitudinal plane 271 to intersect at an orientation angle 280 in the range of 0 degrees-50 degrees. A smaller orientation angle 280 may allow the magnetic elements 210, 211 to have a more compact configuration. An orientation angle 280 close to 0 degrees may be considered to be substantially equivalent to parallel longitudinal planes 270, 271, as depicted in Figures 2D(i) and (ii).

[0091] For example, assuming that the magnetic elements 210, 211 are similar or identical, and the orientation angle 280 during implantation is about 180 degrees as depicted in FIG. 2B, and there is no significant difference in orientation along the second lateral extent, - Longitudinal embedding extent 400a = approximately (2x longitudinal extent of magnetic element) + longitudinal extent of mechanical connector, and lateral embedding extent 400b = approximately (1x maximum lateral extent of magnetic element).

[0092] After implantation, assuming the configuration and arrangement depicted in FIGS. 2D(i) and (ii) is compact, or the orientation angle 280 (FIG. 2C) is about 0 degrees, and assuming there is no significant difference in orientation along the second lateral extent 200f: - The longitudinal embedded extent 200d = approximately (1 x longitudinal extent of magnetic element) + (0.5 x longitudinal extent of mechanical connector) and the lateral embedded extent 200e = approximately (2 x maximum lateral extent of magnetic element).

[0093] this is, - represents a large increase in the lateral embedded extent 200e of approximately (1 x maximum lateral extent of the magnetic element) and a large reduction in the longitudinal embedded extent 200d of approximately (1 x longitudinal extent of the magnetic element) + (0.5 x longitudinal extent of the mechanical connector).

[0094] In summary, the mechanical connector 250: - when deployed (aligned in human or animal tissue), resiliently maintain a first orientation 280 between the first magnetic element 210 and the second magnetic element 211; - configured and arranged to assume a second orientation (not depicted) between the first magnetic element 210 and the second magnetic element 211 during implantation.

[0095] Optionally, mechanical connector 250 may be configured and arranged to assume a further orientation (not depicted) between first magnetic element 210 and second magnetic element 211 prior to implantation, which may additionally or alternatively be complete or partial in the second orientation (not depicted) prior to implantation.

[0096] The mechanical connector 250 provides a rigid coupling between the first magnetic element 210 and the second magnetic element 211, constraining them in a predetermined and / or controlled configuration and arrangement. Generally, the combination of magnetic elements 210, 211 so constrained may be predetermined and / or controlled to provide a particular magnetic configuration and arrangement before implantation (FIG. 2A), during implantation (FIG. 2B), after implantation (FIGS. 2C, 2D), or any combination thereof.

[0097] Possible configurations and arrangements may be optimized to provide one or more desired outcomes, for example: - where configuration and placement after implantation (Figs. 2C, 2D) is considered most critical, less optimal configuration and placement before and / or during implantation (Fig. 2B) may be acceptable; - if configuration and placement during implantation (Fig. 2B) is considered most critical, less optimal configuration and placement before implantation (Fig. 2A) and / or after implantation (Figs. 2C, 2D) may be acceptable; If the magnetic marker 200 should be easy to insert into the implantation channel 400, the difference between the volume of the magnetic marker before implantation (FIG. 2A) and the implanted volume (FIG. 2B) may be reduced. In particular, the difference in lateral extent may be reduced if: If the magnetic marker 200 should be easily removed from the implantation channel 400, the difference between the implantation volume (FIG. 2B) and the implanted volume of the magnetic marker (FIGS. 2C, 2D) may be reduced. In particular, the difference in lateral extent may be reduced. - If the resistance to movement of the magnetic marker 200 during implantation is to be increased, the difference between the volume of the magnetic marker before implantation (Fig. 2A) and the implanted volume (Fig. 2B) may be increased. In particular, the difference in lateral extent may be increased. This may be advantageous to prevent unwanted deployment of the implantable magnetic marker 200 during implantation. Additionally or alternatively, the resistance to movement during implantation may be increased by increasing the difference between the implanted volume (Fig. 2B) and the implanted volume of the magnetic marker (Figs. 2C, 2D). In particular, the difference in lateral extent may be increased. Additionally or alternatively, if resistance to movement of the magnetic marker 200 is to be increased during implantation, the orientation difference between the first magnetic element 210 and the second magnetic element 211 before implantation (FIG. 2A) will maintain the orientation with increased elasticity. After inserting the magnetic marker 200 into the implantation channel 400, the increased elasticity may exert an increased force against the inner surface of the hole 400b.

[0098] Generally, the combination of magnetic elements 210, 211 so constrained may be predetermined and / or controlled to provide a particular magnetic configuration and arrangement after implantation (FIGS. 2C, 2D).

[0099] For example, the first magnetic element 210 and the second magnetic element 211 may be held closer together after implantation, such that both poles are closer to the corresponding pole of the other element, which may increase the outward magnetic field and therefore the detectability of the magnetic marker 200. An example is depicted in FIG. 3C (which is described further below), where the north poles 240, 241 and south poles 245, 246 are aligned along longitudinal planes 270, 271 for each magnetic element 210, 211. The north poles 240, 241 are held closer together by the mechanical connector 250, and the south poles 245, 246 are also held closer together by the mechanical connector 250. For acceptable deployment, the mechanical connector 250 is configured and arranged to overcome the repulsive magnetic force when like poles are brought closer together. Optionally, like poles may be brought into contact, as depicted in FIG. 3C.

[0100] For example, the first magnetic element 210 and the second magnetic element 211 may be held closer together after implantation, with one pole closer to the opposite pole of the other element, which may also increase the outward magnetic field and therefore the detectability of the magnetic marker 200. An example is depicted in Figures 10B and 10C (which are described further below), where the north poles 240, 241 and south poles 245, 246 are aligned along a generally transverse plane (not depicted, but generally perpendicular to the longitudinal planes 270, 271) relative to each magnetic element 210, 211. The north pole 240 of the second magnetic element 211 is held closer to the south pole 245 of the first magnetic element 210 by the mechanical connector 250. For an acceptable deployment, the mechanical connector 250 is configured and arranged such that an attractive magnetic force can bring the elements into contact as the opposite poles are brought closer together. Optionally, the opposite poles may be contacted, as depicted in FIG. 10C.

[0101] The mechanical connector 250 may comprise any suitable material for applying a restraining force, such as metal. The mechanical connector 250 may be attached to the magnetic elements 210, 211 using any suitable means, such as welding, laser welding, adhesive and / or glue. Attachment may be at one or more locations, such as along one of the ends and / or sides of the magnetic elements 210, 211. Additionally or alternatively, attachment may be to the exterior surface of the magnetic elements 210, 211 and / or in a suitable hole or recess.

[0102] For example, the mechanical connector 250 may comprise one or more materials selected from the group including superelastic materials, pseudoelastic materials, shape memory materials, titanium, stainless steel, surgical stainless steel, cobalt-chromium, nickel-titanium alloy (nitinol), platinum, tungsten, silver, gold, tantalum, iridium, or alloys thereof, or any combination thereof.

[0103] In the concepts of the present disclosure, the magnetic elements 210, 211 may essentially be one or more permanent magnets (coated or uncoated) or assemblies including one or more permanent magnets, which may be used interchangeably in all of the embodiments described in this disclosure.

[0104] For example, any suitable neodymium permanent magnet may be used, with relatively high magnetic strength being preferred. However, in practice, the following practical problems may arise: - Not all permanent magnet materials are sufficiently biocompatible. When the outer surface of a permanent magnet comes into contact with human or animal tissue, corrosion and / or unwanted chemical or ecological reactions may occur. The biocompatibility of magnets may be improved by improving the surface finish and / or applying coatings such as parylene, gold, nickel, etc. This may increase the price of such magnetic elements and there may be adhesion problems with the coating. Surface finishes or coatings are also prone to (partial) failure, which would still expose the human body to less biocompatible magnets.

[0105] 7B, first magnetic element 210 and / or second magnetic element 211 may alternatively include a housing 230 with a cavity, enclosing permanent magnet 220 within said cavity. Because the exterior surface of housing 230 is exposed to tissue, the housing may be constructed and arranged to include one or more materials with a high degree of corrosion resistance and / or biocompatibility, such as titanium, stainless steel, surgical stainless steel, cobalt-chromium, nickel-titanium alloy (nitinol), platinum, tungsten, silver, gold, tantalum, iridium, or alloys thereof, or any combination thereof.

[0106] In contrast, the permanent magnet 220 contained within the cavity may be optimized for a magnetic strength that does not require such a high degree of biocompatibility.

[0107] 7A depicts a longitudinal cross section through a suitable permanent magnet 220. This has a volume of magnetic elements with a longitudinal extent 220a, a first lateral extent 220b, and a second lateral extent (not depicted), which is included in the volume of the magnetic marker 200. Depending on the number of magnetic elements, their configuration, and their placement, this may determine one or more longitudinal extents and / or one or more lateral extents of the magnetic marker 200.

[0108] In many embodiments, the larger of the first lateral extent 220b and the second lateral extent may determine the minimum lateral extent within which the bore of the embedded channel must fully receive the magnetic marker 200. Typically, such a magnet 220 will have a longitudinal extent 220a of 4.7 mm. Because the magnet 220 is encapsulated, a negative tolerance, i.e., +0-0.10 mm, is preferred. An example of this is a cylindrical shape having a substantially rounded (circular) cross-section with a lateral diameter 220b of 1.45 mm and a negative tolerance of +0-0.10 mm. Optionally, triangular, rectangular, polygonal, elliptical, or oval cross-sections may also be used. Optionally, the edges may be rounded to avoid sharp edges, e.g., with a radius R of 0.10 mm. While depicted as having a relatively constant longitudinal cross-section, other shapes, such as a tapered, diamond, or bead shape, may also be used.

[0109] 7B depicts a longitudinal section through a suitably enclosed 230 permanent magnet 220. The enclosure 230 may also be described as a housing, case, or casing. For purposes of this disclosure, the enclosure 230 is not a covering. The enclosure 230 has a volume of magnetic elements with a longitudinal extent 230a, a first lateral extent 230b, and a second lateral extent (not depicted). This is included in the volume of the magnetic marker 200. Depending on the number of magnetic elements with the enclosure, their configuration, and their arrangement, this may determine one or more longitudinal extents and / or one or more lateral extents of the magnetic marker 200.

[0110] In many embodiments, the larger of the first lateral extent 230b and the second lateral extent may determine the minimum lateral extent the bore of the embedded channel must have to fully receive the magnetic marker 200. Typically, such an encapsulated magnet 230 will have a longitudinal extent 230a of 5.2 mm + / - 0.20 mm. An example of this is a cylindrical shape with a substantially rounded (circular) cross-section, with a transverse diameter 230b of 1.65 mm + / - 0.05 mm. Optionally, triangular, rectangular, polygonal, elliptical, or oval cross-sections may also be used. Optionally, the edges may be rounded to avoid sharp edges, e.g., with a radius R of 0.20 mm. Although depicted as having a relatively constant longitudinal cross-section, other shapes, such as tapered, diamond-shaped, or bead-shaped, may also be used.

[0111] Additionally, the dimensions and shape of the housing 230 may be the same as, similar to, or different from the corresponding dimensions and shape of the enclosed magnet 220. This may be advantageous when a permanent magnet of the appropriate size and shape is not available. Additionally or alternatively, two or more permanent magnets may be enclosed.

[0112] For example, a permanent magnet 220 with a longitudinal extent 220a of 1.45 mm and first and second lateral extents 220b and 230b (not depicted) of 4.7 mm may be enclosed within a housing 230 with a wall thickness of 0.1 mm to provide an assembled longitudinal extent 230a of 1.65 mm and assembled first and second lateral extents 230b and 230b (not depicted) of 5.2 mm. Such a magnetic element assembly 210, 211 may be implanted using a 14G needle with an inner diameter (bore) of 1.8 mm / outer diameter of 2.1 mm.

[0113] Optionally, housing 230 is configured and arranged within said cavity to substantially seal permanent magnet 220. The degree to which housing 230 should be sealed depends on the environmental conditions at the implantation site and the degree of biocompatibility of the cavity, as well as the biocompatibility of permanent magnet 230 specifically.

[0114] Optionally, housing 230 may include multiple housing parts attached together to form an outer wall of housing 230 that encloses permanent magnet 220 within the cavity. For example, housing 230 may include a longitudinally extending hollow sleeve and two end caps. Alternatively or additionally, housing 230 may include two longitudinally extending hollow end caps. These parts may be fabricated to mechanically fit together; however, other techniques, such as welding, laser welding, bonding, and / or gluing, may also be used.

[0115] When a housing 230 is used to enclose one or more permanent magnets 220, the mechanical connectors 250 may be attached to one or more suitable locations on the housing 230 and / or to one or more suitable locations on the permanent magnets 220. Any suitable means may be used, such as welding, laser welding, bonding and / or gluing. Attachment may be at one or more locations, such as along one of the ends and / or sides of the magnetic elements 210, 211. Attachment may be to an exterior surface and / or in a suitable hole or recess.

[0116] One or more attachments to the housing 230 may be advantageous when using permanent magnet materials where attachment (e.g., by gluing) may not be stable enough for reliable regular use and welding is not feasible or desirable. Additionally, the risk of damage to the surface of the permanent magnet, which may create unwanted magnetized particles or debris, is reduced.

[0117] One or more attachments to the permanent magnet 220 may also be used with the housing 230, for example through holes may also be used, which allow attachment to the permanent magnet 220 inside the housing 230 and / or cavity.

[0118] The mechanical connector 250 may be pre-formed to provide the predetermined orientation angle 280, may be bent after implantation, may be configured to bend after implantation, or some combination thereof.

[0119] Although depicted in two dimensions, determining and / or controlling the orientation angle 280 and degree of proximity may need to be optimized in more than one degree of freedom to achieve sufficient deployment of the desired magnetic configuration and arrangement.

[0120] To simplify implantation, mechanical connector 250 may be further configured and arranged, prior to and / or during implantation, to adopt a second orientation angle 280 between first longitudinal plane 270 and second longitudinal plane 271, as depicted in Figures 2A and / or 2B, such that maximum lateral extent 200b is as small as possible. In most cases, this increases longitudinal extent 200a. In many cases, longitudinal extent 200a is as large as possible.

[0121] This allows the magnetic marker 200 to be implanted using a hollow embedding channel 400, such as a needle. Prior to and / or during implantation, the maximum lateral extent 200b of the magnetic marker 200 is configured and positioned to fit within the bore 400b of the embedding channel 400. A suitable bore 400b may have an inner diameter slightly larger than the maximum lateral extent 200b of the magnetic marker 200.

[0122] Because the permanent magnets are embedded, it may be advantageous to use weakly magnetic materials within the embedded channel 400 that have a reduced, low, or slight degree of ferromagnetism when exposed to the magnetic field strength generated by the permanent magnets used.

[0123] For example, non-ferrous metals, titanium, aluminum, platinum, gold, silver, copper, glass, PTFE, or plastic. One of many steels may also be used, such as stainless steel, some martensitic stainless steels, or one of many austenitic stainless steels. These materials exhibit a reduced, low, or slight magnetic response, which may reduce or avoid the degree of magnetic attraction between the permanent magnet and the buried channel 400.

[0124] Weakly magnetic composites of such materials may be used, which have a relative permeability in the range of μr=1.00001-2 or 1.00001-4, evaluated according to ASTM A342 / A342M - 14 (2014) Standard Test Methods for Permeability of Weakly Magnetic Materials.

[0125] After passing through hole 400b, when maintaining first orientation angle 280 (post-implantation, as depicted in FIGS. 2C and 2D), the embedded lateral extent 200ef of magnetic marker 200 is significantly greater than lateral embedded extent 400b, which is less than or equal to the maximum lateral extent of hole 400b. In other words, the increase in embedded lateral extent 200ef after implantation means that when mechanical connector 250 elastically maintains first orientation angle 280, it will be too expanded to fit within hole 400b of implantation channel 400.

[0126] Second orientation angle 280 (not depicted in FIG. 2A or 2B) is preferably in the range of 160-200 degrees, and most preferably about 180 degrees.

[0127] For example, if mechanical connector 250 comprises spring steel, mechanical connector 250 may be constructed and arranged to resiliently retain the embedded first orientation angle 280 depicted in FIG. 2C or 2D.

[0128] In the embodiments depicted in this disclosure, proper deployment requires a predetermined and / or controlled alignment of the north and south magnetic poles, which may be determined by detecting their orientation before, during, and / or after assembly and placing the poles according to a predetermined alignment.

[0129] The use of the housing 230 allows the magnetic pole arrangement to be configured and arranged in the same, similar or different way as the physical arrangement of the magnetic elements, allowing for displacement and / or rotation.

[0130] It may be particularly advantageous to determine and / or control the alignment of the poles by configuring and arranging the permanent magnets 220 to rotate. When such magnetic elements are approached by different mechanical elements, the rotatable permanent magnets 220 rotate independently of the housing inside the housing to ensure that the opposite poles face each other, and thus magnetic attraction occurs between the magnetic elements.

[0131] In such embodiments, it may be advantageous to use a weakly magnetic material within the housing that has a reduced, low, or slight degree of ferromagnetism when exposed to the magnetic field strength generated by the employed permanent magnet 220. For example, non-ferrous metals, titanium, aluminum, platinum, gold, silver, copper, glass, PTFE, or plastic. One of many steels may also be used, such as stainless steel, some martensitic stainless steels, or one of many austenitic stainless steels. These materials exhibit a reduced, low, or slight magnetic response, which may reduce or avoid the degree of magnetic attraction between the permanent magnet and the housing 230.

[0132] Weakly magnetic composites of such materials may be used, which have a relative permeability in the range of μr=1.00001-2 or 1.00001-4, evaluated according to ASTM A342 / A342M - 14 (2014) Standard Test Methods for Permeability of Weakly Magnetic Materials.

[0133] Figures 3A, 3B, and 3C depict schematic longitudinal cross sections of how the magnetic marker 200 depicted in Figure 2 can be implanted. These figures depict possible static scenarios of the dynamic implantation process.

[0134] Figure 3A depicts the same situation as depicted in Figure 2B. The magnetic marker 200 is arranged within an inner bore 400b of an implantation channel 400, such as a hollow syringe needle. The marker implantation volume can thus be considered to have a longitudinal implantation extent equal to the longitudinal bore extent (not depicted), a first lateral extent equal to the first lateral bore extent 400b, and a second lateral extent equal to the second lateral bore extent (not depicted).

[0135] 3A depicts magnetic elements 211 and 210 coupled with a mechanical connector. The first magnetic element 210 is closest to the opening of the implantation channel (depicted on the right) and appears first during implantation. The magnetic poles are also depicted, namely, from left to right (arranged along the longitudinal plane), north pole 241 and south pole 246 of second magnetic element 211, and south pole 245 and north pole 240 of first magnetic element 210. Mechanical connector 250 extends between south pole 246 of second magnetic element 211 and south pole 245 of first magnetic element 210. In other words, magnetic marker 200 includes: [N 211 S]==[S 210 N]⇒(Opening)

[0136] 3A, the south poles of first magnetic element 210 and second magnetic element 211 are held closer together by mechanical connector 250. Mechanical connector 250 thus overcomes the repulsive magnetic forces to allow for a predetermined and / or controlled configuration and / or placement prior to and / or during implantation.

[0137] A suitable bore 400b of the channel 400 may have an inner diameter slightly larger than the maximum lateral extent (not depicted in FIG. 3A) of the magnetic marker 200. The size of the bore 400b may be primarily determined using the maximum lateral extent (or diameter) (not depicted) of the two or more magnetic elements 210, 211, where the second orientation angle 280 (not depicted in FIG. 3A) is preferably in the range of 160-200 degrees, and most preferably about 180 degrees.

[0138] The elements of magnetic material embedded depend on parameters such as the first and second lateral extent (or diameter) of each magnetic element 210, 211, the length (or longitudinal extent) of each magnetic element 210, 211, the number of magnetic elements 210, 211, and the thickness of any housing 230 encapsulating one or more magnetic elements 210, 211.

[0139] Those skilled in the art will recognize that the extent of the magnetic elements 210, 211 and the extent of the bore 400b of the channel 400 may be predetermined and / or controlled to provide for convenient implantation. For example, since the dimensions and mechanical properties of injection needles are usually standardized, it may be more convenient to select magnetic elements 210, 211 with an extent suitable for passing through a standard bore 400b.

[0140] For example, standards for stainless steel piping for manufacturing medical devices can be found at ISO 9626, now 9629:2016, published in August 2016, www.iso.org / standard / 60480.html.

[0141] for example, ID (Internal Diameter) = Inner diameter or hole of injection channel 400 (mm) OD (Outer Diameter) = Outer diameter (mm), WT (Wall Thickness) = Wall thickness (mm) Capacity = Capacity of magnetic material determined by the dimensions of the magnetic element (mm 3 ) (assuming a cylinder) = L.π.D 2 / 4 Max. Diam (maximum diameter) = Maximum diameter that can be embedded using a particular needle size. If a magnetic element is contained within any of the housings 230 described above, the diameter of the embedded magnetic element is reduced by the wall thickness of the housing 230 (e.g., 0.2 mm) (Max. Diam (maximum diameter) within the housing 230)

[0142] The length of the magnetic elements 210, 211 may be any suitable size, but a length of 4.7 mm is assumed for the following calculations of the volume of magnetic material. When contained within any enclosure 230, the total length of each housed element should be 5.2 mm.

[0143] [Table 1]

[0144] The ID (Internal Diameter), OD (Outer Diameter), and WT (Wall Thickness) values ​​are just estimates used here to illustrate how magnetic capacitance can be estimated. The Max. Diam. (maximum diameter) is based on these estimated OD (Outer Diameter) using the same tolerances that seem appropriate for 14G needles (i.e., Max. Diam. (maximum diameter) = 0.05 mm smaller than the needle ID (Internal Diameter)).

[0145] The Max.Diameter (maximum diameter) within the housing 230 was determined using the same wall thickness of the housing 230 (0.1 mm) and the ratio between the length of the housing 230 and the length of the magnetic element. For example, a titanium housing may be used with this wall thickness.

[0146] When a single magnetic element 210, 211 with dimensions 1.45mm x 4.7mm is embedded in the housing using a 14G needle (top row), the volume of the magnetic material is approximately 7.76mm 3 It should be.

[0147] To implant a similar volume of magnetic material using a 16G needle (middle row), one would need at least two magnetic elements 210, 211 with dimensions of 1.05mm x 4.7mm.

[0148] To implant a similar volume of magnetic material using an 18G needle (bottom row), one would need at least four magnetic elements 210, 211 with dimensions of 0.8mm x 4.7mm.

[0149] For example, if the embedded channel 400 depicted in FIG. 3 is the bore 400b of a 16G needle, the magnetic marker 200 including the first magnetic element 210 and the second magnetic element 211 connected by the mechanical connector 250 would be 8.14 mm 3 It may refer to the capacitance of a magnetic material.

[0150] Prior to and / or during implantation, a second orientation angle 280 is assumed between first longitudinal plane 270 and second longitudinal plane 271. This second orientation angle 280 is the assumed orientation angle for implantation, in this case approximately 180 degrees, to allow for the use of smaller diameter needles.

[0151] Preferably, the mechanical connector 250 is constructed and arranged to withstand the mechanical forces exerted within the needle bore 400b without undergoing plastic deformation.

[0152] The mechanical connector 250 may also be configured and arranged to return (spring back) to a similar or identical shape (configuration and arrangement) to its "pre-implantation" shape after the magnetic marker 200 is removed from the hole 400b.

[0153] It is particularly advantageous to configure and arrange the mechanical connector 250 so that the "before implantation" and "after implantation" are similar or identical, where the magnetic marker 200 is temporarily opened (or expanded) during implantation in order to pass through the hole 400b of the implantation channel.

[0154] 3B depicts the emergence of the first magnetic element 210 and the mechanical connector 250 from the opening or implanted channel 400 during implantation. In other words, "==[S 210 N]" emerges.

[0155] In this case, mechanical connector 250 is constructed and arranged such that orientation angle 280 between first longitudinal plane 270 and second longitudinal plane 271 can be approximately 90 degrees, which in this case is an intermediate orientation angle between the buried orientation (depicted in FIG. 3A) and the embedded orientation (depicted in FIG. 3C).

[0156] As depicted, the south poles of first magnetic element 210 and second magnetic element 211 are also held more proximally by mechanical connector 250. Mechanical connector 250 thus overcomes the repulsive magnetic forces to allow for a predetermined and / or controlled configuration and / or placement after implantation.

[0157] Figure 3C depicts the completion of the embedding, in other words, the appearance of "[N 211 S]".

[0158] The mechanical connector 250 allows the orientation angle between the first longitudinal plane 270 and the second longitudinal plane 271 (not depicted in FIG. 3C ) to adopt its embedded orientation and be maintained by the application of a mechanical force. In this case, the first longitudinal plane 270 and the second longitudinal plane 271 are substantially parallel. This is substantially the same orientation as the orientation angle (not depicted in FIG. 3C ), which is about 0 degrees. The embedded configuration and arrangement are also depicted in FIGS. 2D(i) and 2D(ii).

[0159] As depicted, south poles 245, 246 of magnetic elements 210, 211 are held in close proximity by mechanical connector 250, and north poles 240, 241 of magnetic elements are also held in close proximity by mechanical connector 250. Mechanical connector 250 thus overcomes the repulsive magnetic forces to allow for a predetermined and / or controlled configuration and / or arrangement. In other words, the implanted configuration and arrangement may be schematized as follows: [N 210 S]=. [N 211 S]='

[0160] Orientation angles near 0 degrees or substantially parallel longitudinal planes 270, 271 are particularly advantageous in providing a reduced, greater lateral extent of embedded orientation. However, larger orientation angles may actually be acceptable. For example, a greater degree of separation between the ends of magnetic elements 210 and 211 having the same pole may actually be acceptable. Such embodiments may be able to use mechanical connectors 250 that apply a relatively weaker mechanical force; for example, thinner wires and / or ribbons may be used.

[0161] Simulations were performed to determine the effect of such separation or non-zero orientation angles using two magnetic elements 210, 211, measuring 1.05 mm x 4.7 mm and comprising N52M magnetic material with a relative permeability of 1.05 and a permanent magnetic flux density of 1.46 T, oriented along their longitudinal axes. The simulation values ​​were compared with simulation results for a single magnetic element measuring 1.45 mm x 4.7 mm. The conclusion was that separations of 2 mm or less and orientation angles of 0-50 degrees did not significantly affect the magnetic field.

[0162] It may be particularly advantageous if the mechanical connector 250 includes one or more superelastic, pseudoelastic, shape memory materials, Nitinol, Fe—Mn—Si, Cu—Zn—Al, and Cu—Al—Ni, or any combination thereof, which may be used to predetermine and / or control the configuration and placement of the magnetic elements.

[0163] This allows the embedded orientation (eg in FIG. 3A) to be temporarily adopted and / or the embedded orientation (eg in FIG. 3C) to be automatically adopted.

[0164] Superelasticity, pseudoelasticity, and shape memory are physical properties of certain metal alloys that allow these materials to be formed into predetermined shapes at elevated temperatures and then be very flexible while still retaining their original shape (i.e., no or very limited plastic deformation).

[0165] For example, the mechanical connector 250 may be configured and arranged to be substantially straight (at an orientation angle of approximately 180 degrees) when loaded into the hole 400 during implantation (FIGS. 2A and 3A), and to substantially return to a predetermined shape when deployed (implanted, FIG. 3C) to constrain the magnetic elements 210, 211 in a predetermined and / or controlled magnetic configuration due to their superelastic properties.

[0166] Nitinol is a metallic alloy of nickel and titanium, where the nickel and titanium are present in approximately equal atomic percentages. Different alloys are named according to the weight percentage of nickel, such as Nitinol 55 and Nitinol 60. It exhibits shape memory effect and superelasticity at different temperatures.

[0167] In the example depicted in Figures 2A-2D, mechanical connector 250 includes a single nitinol wire whose cross-section has a generally circular diameter.

[0168] For example, a diameter of 0.25 mm and a longitudinal extent of at least 1.96 mm (depicted in the embedded orientation in Figure 3A) may be used.

[0169] Parameters of the mechanical connector 250 that may be predetermined and / or controlled to configure and position the orientation angle 280 before, during, and / or after implantation include: - longitudinal extent. It may be advantageous to use a longitudinal extent of more than 1.96 mm (1.96 mm represents the minimum longitudinal extent required to connect two magnetic elements 210, 211). Indeed, an increased longitudinal length, for example about 3 mm, may allow for increased flexibility in achieving the desired orientation and, in some cases, may reduce the risk of plastic deformation. Cross-Section. While depicted in Figures 2A-2D with substantially circular cross-section wires, mechanical connector 250 may have a circular, triangular, rectangular, square, polygonal, elliptical, oval cross-section, or any combination thereof. The cross-section may also vary at different points along its longitudinal extent. - the materials used. The materials used may also vary at different points along their longitudinal and / or transverse extent, - first and second lateral extents, which may also vary at different points along their longitudinal extent; - Including one or more depressions, recesses, grooves, protrusions, ridges, cuts, tapers, or the like at one or more locations along the longitudinal extent. - Including one or more voids, cavities, holes, channels, or the like at one or more locations along its lateral extent. Mechanical connector 250 may optionally be substantially hollow. Such cavities may be at least partially filled with one or more similar or different materials.

[0170] Additionally or alternatively, mechanical connector 250 may include one or more connector elements, such as two wires with the same, similar, or different properties, and may be used to configure and position orientation angle 280 before, during, and / or after implantation.

[0171] Additionally or alternatively, mechanical connector 250 may include one or more connector elements that are closer together or attached to one another.

[0172] 2E depicts an example of a modified first embodiment 200E of an implantable magnetic marker, which is the same as the magnetic marker 200 depicted in FIGS. 2A-2D, except for the following: As in FIG. 2A, a longitudinal section is taken through the magnetic marker, in this case through the modified marker 200E including the modified mechanical connector 250E. The modified first embodiment 200E may have the same, similar or different longitudinal extents. Additionally or alternatively, it may have the same, similar or different first or second lateral extents. - dashed line XX is shown at the attachment point of the modified mechanical connector 250E to the second magnetic element 211. A cross section through this line XX is also depicted, Instead of mechanical connector 250 including one wire with a substantially circular cross-section, modified mechanical connector 250E includes multiple wires with substantially circular and similar cross-sections; In this example, three connector elements are rigidly attached to one another to form a ribbon-type mechanical connector 250E, with a first lateral extent approximately equal to one diameter and a second lateral extent approximately equal to three diameters.

[0173] The multiple connector elements may be configured and positioned at an orientation angle (not depicted in FIG. 2E) before, during, and / or after implantation, depending on the following additional parameters: - have the same, similar or different characteristics, such as those mentioned above, for one or more connector elements; - the proximity of the connector elements to each other, Those skilled in the art will recognize that the degree to which connector elements are attached to one another may also be provided. The attachment may also vary at different locations along the longitudinal extent, i.e. - the relative orientation of the different faces of each connector element with respect to one another if one or more cross sections are not substantially circular; - Relative lateral position, e.g., three connector elements may be arranged in a triangular configuration, four connector elements may be arranged in a square configuration, six connector elements may be arranged in a rectangular configuration. Additionally or alternatively, each row or column of connector elements (as viewed in cross section) may be offset by approximately half a diameter to provide multiple triangular configurations. - Orientation of the connector element relative to the magnetic element or elements 210, 211. Bending occurs more easily, for example, when the cross section is smaller.

[0174] Figure 2F depicts a further example of a modified first embodiment 200F of an implantable magnetic marker, which is the same as the magnetic marker 200 depicted in Figure 2E, except for the following: 2E, a schematic plan view of a magnetic marker is depicted, in this case via a modified marker 200F including a further modified mechanical connector 250F. The modified first embodiment 200F may have the same, similar or different longitudinal extents. Additionally or alternatively, it may have the same, similar or different first or second lateral extents. - dashed line YY indicates the attachment point of the further modified mechanical connector 250FE to the second magnetic element 211. A cross section through this line YY is also depicted. Instead of the mechanical connector 250E containing three wires, a wire 250F with a substantially rectangular cross section is provided.

[0175] For example, modified mechanical connector 250F may have a cross-sectional extent of 0.25 mm and 0.50 mm and a longitudinal extent of at least 1.96 mm (as depicted in the pre-implantation and / or implantation orientation of FIG. 3A). Alternatively, a cross-sectional extent of 0.2 mm x 0.4 mm or 0.2 mm x 0.6 mm may be advantageous. Alternatively or additionally, a longitudinal extent of 3 mm or greater may be advantageous.

[0176] It will be apparent to one skilled in the art that the direction of bending can be influenced by determining and / or controlling the orientation of a smaller area of ​​the cross-section. In other words, bending is easier through a smaller cross-section (e.g., in the 0.25 mm direction) than through a larger area (e.g., in the 0.5 mm direction).

[0177] Generally, the capacity of the embedded magnetic material may be increased by using magnetic markers that include additional magnetic elements, each attached using an appropriately configured mechanical connector.

[0178] Figures 10A, 10B, and 10C depict a further embodiment of an implantable magnetic marker 204. Figure 10A depicts a schematic plan view of the magnetic marker 204 before and / or during implantation. Figures 10B and 10C depict schematic plan views of the magnetic marker 204 after implantation. The marker 204 is the same as that described above in connection with Figures 2A, 2B, 2C, and 2D, and Figures 3A, 3B, and 3C, with the following exceptions: As depicted in Figure 10A, before and / or during implantation, the magnetic marker 204 has a marker volume with a longitudinal extent 204a, a first lateral extent 204b, and a second lateral extent (not depicted). These extents 204a, 204b may be the same, similar, or different compared to the respective extents 200a, 200b depicted in Figure 2A. As depicted in Figure 10B, after implantation, the magnetic marker 204 has an embedded marker volume with an embedded longitudinal extent 204d, a first lateral extent 204e, and a second lateral extent (not depicted), which may be the same, similar, or different compared to the respective extents 200d, 200e depicted in Figure 2C. As depicted in Figure 10C, after implantation, the magnetic marker 204 has an embedded marker volume with an embedded longitudinal extent 204d, a first lateral extent 204e, and a second lateral extent (not depicted), which may be the same, similar, or different from the respective extents 200d, 200e depicted in Figure 2D. for each magnetic element 210, 211, the north poles 240, 241 and south poles 245, 246 are arranged substantially along a first transverse plane (not depicted, but substantially perpendicular to the longitudinal planes 270, 271), as depicted in FIG. 10A; The mechanical connector 250 is between: - the position between the north pole 241 and the south pole 246 of the second magnetic element 211, and extends to a position between the south pole 245 and the north pole 240 of the first magnetic element 210;

[0179] In other words, the magnetic marker 204 includes: [N] [S] |211|====|210| [S] [N]

[0180] 10A, south pole 245 of first magnetic element 210 and north pole 241 of second magnetic element 211 are held more proximally by mechanical connector 250. Additionally, south pole 246 of second magnetic element 211 and north pole 240 of first magnetic element 210 are held more proximally by mechanical connector 250. Mechanical connector 250 thus overcomes the attractive magnetic force to allow for a predetermined and / or controlled configuration and / or placement prior to and / or during implantation.

[0181] The magnetic markers 204 may be embedded in a manner similar to the embodiments described above in connection with FIGS. 2A, 2B, 2C, and 2D, and FIGS. 3A, 3B, and 3C, with the following exceptions: 10B and 10C, after implantation, the north pole 241 of the second magnetic element 211 is held more proximal to the south pole 245 of the first magnetic element 210 by the mechanical connector 250. In FIG. 10B, the first longitudinal plane 270 and the second longitudinal plane 271 intersect at an orientation angle 280 of 0-50 degrees. A smaller orientation angle 280 may result in a more compact configuration of the magnetic elements 210, 211. An angle 280 close to 0 degrees may be considered substantially equivalent to parallel longitudinal planes 270, 271, as depicted in FIG. 10C.

[0182] The mechanical connector 250 is thus constructed and arranged to allow for a predetermined and / or controlled configuration and / or arrangement in which the attractive magnetic forces bring the opposite poles of the magnetic elements closer together (as in FIG. 10B), in close proximity, or even touching (as depicted in FIG. 10C).

[0183] In other words, the embedded configuration and arrangement can be diagrammed as follows: [ N ] |210| [ S ]==. [ N ]==' |211| [ S ]

[0184] For example, assuming that the magnetic elements 210, 211 are similar or identical, and the orientation angle 280 after implantation is about 180 degrees as depicted in FIG. 10A, and there is no significant difference in orientation along the second lateral extent, - Longitudinal embedding extent 204a = approximately (2 x longitudinal extent of magnetic element) + longitudinal extent of mechanical connector, and lateral embedding extent 204b = approximately (1 x maximum lateral extent of magnetic element).

[0185] After implantation, assuming the configuration and arrangement depicted in FIG. 10C is compact, or the orientation angle 280 (FIG. 10B) is about 0 degrees, and assuming there is no significant difference in orientation along the second lateral extent (not depicted), - The longitudinal embedded extent 204d = approximately (1 x longitudinal extent of magnetic element) + (0.5 x longitudinal extent of mechanical connector), and the lateral embedded extent 204e = approximately (2 x maximum lateral extent of magnetic element).

[0186] this is, - represents a large increase in the laterally embedded extent 204e of approximately (1 x maximum longitudinal extent of the magnetic element) and a large reduction in the longitudinally embedded extent 204d of approximately (1 x longitudinal extent of the magnetic element) + (0.5 x longitudinal extent of the mechanical connector).

[0187] Figures 8A, 8B, 8C, and 8D depict further embodiments of implantable magnetic markers 203, 206. Figure 8A depicts a schematic plan view of magnetic marker 203 before and / or during implantation. Figures 8B and 8C depict schematic plan views of magnetic marker 203 after implantation. Figure 8D depicts a schematic plan view of magnetic marker 206 after implantation.

[0188] The marker 203 is the same as that described above in connection with FIGS. 2A, 2B, 2C, and 2D, and FIGS. 3A, 3B, and 3C, except for the following: As depicted in Figure 8A, before and / or during implantation, the magnetic marker 203 has a marker volume with a longitudinal extent 203a, a first lateral extent 203b, and a second lateral extent (not depicted), which may be the same, similar, or different compared to the respective extents 200a, 200b depicted in Figure 2A; As depicted in Figures 8B and 8C, after implantation, the magnetic marker 203 has an embedded marker volume with an embedded longitudinal extent 203d, a first lateral extent 203e, and a second lateral extent 203f, which may be identical, similar, or different from the respective extents 200d, 200e, 200f depicted in Figures 2D(i) and (ii); the mechanical marker 203 further comprises one or more mechanical anchors 260, 261 configured and arranged as one or more tissue anchors 260, 261 attached to the first magnetic element 210 at an opposite end of the mechanical connector 250; - The ranges 200a, 200b and the second lateral range (not depicted) may also be determined by the shape of the one or more mechanical anchors 260, 261 and the orientation between the one or more mechanical anchors (###) 260, 261 and the magnetic marker 203.

[0189] The magnetic marker 203 includes: ###

[0210] ==

[0211]

[0190] In the same manner as described above in connection with FIGS. 2A, 2B, 2C, and 2D, and FIGS. 3A, 3B, and 3C, the mechanical connector 250 - retain a first orientation (not depicted) when deployed and adopt a second orientation (not depicted) during embedding; - may optionally be constructed and arranged to assume a further orientation (not depicted) prior to implantation.

[0191] The magnetic marker 203 may be further configured and arranged as follows: each mechanical anchor 260, 261 may be configured and arranged to resist changes in position of one or more magnetic elements 210, 211 when arranged within human or animal tissue. In other words, after deployment and / or implantation, each mechanical anchor 260, 261 has a first anchor shape and / or a first anchor orientation relative to the magnetic marker 203 that is configured and arranged to significantly resist changes in position of one or more magnetic elements 210, 211. Optionally, each tissue anchor 260, 261 may be arranged in one or more longitudinal planes and / or one or more transverse planes.

[0192] Generally, tissue anchors, also referred to as tissue fasteners or tissue fixators, are constructed and arranged to resist movement of magnetic elements and / or magnetic markers, e.g., they may be used to assist in securing the magnetic markers during implantation and / or to resist movement of the magnetic markers after implantation. Anchor is used as a general term for any element that provides some degree of resistance to movement due to physical parameters such as the element's 3D shape, element dimensions, orientation relative to the magnetic marker, presence of sharp points, presence of hooks or barbs, surface contour, surface roughness, protrusions, depressions, recesses, holes, or cavities. In some cases, resistance is provided directly after implantation or increases due to enhanced tissue in-growth, or any combination thereof. Additional examples of mechanical anchors are depicted in Figures 13A-13I and described below.

[0193] Additionally or alternatively, - Between the proximal magnetic markers, - between the proximal magnetic elements, - between the magnetic marker and any embedded channels, - Between the magnetic marker and any surgical instruments used before, during or after implantation; - It may be advantageous to resist movement and / or displacement due to magnetic attraction and / or repulsion, or any combination thereof.

[0194] Additionally or alternatively, one or more mechanical anchors 260, 261 may include: - at the end opposite the mechanical connector 250 to the second magnetic element 211, - mechanical connector 250, at the end with a mechanical connector 250 to the second magnetic element 211, at the end with a mechanical connector 250 to the first magnetic element 210, and any combination thereof.

[0195] 8D depicts a modified implantable magnetic marker 206 with one tissue anchor 260 attached to the first magnetic element 210 at the end opposite the mechanical connector 250 with an implanted longitudinal extent 206d after implantation, which may have a reduced first lateral extent 206e after implantation compared to the first lateral extent 203e of FIGS. 8B and 8C, where the maximum lateral extent is determined by the tissue anchors 260, 261. In all other aspects, the modified implantable magnetic marker 206 depicted in FIG. 8D is the same as the implantable marker 203 depicted in FIGS. 8A-8C.

[0196] The one or more tissue anchors 260, 261 are constructed and positioned using similar manufacturing and attachment techniques as the mechanical connector 250. In particular, the tissue anchors 260, 261 may comprise any suitable material for applying a fixation force, such as one or more metals and / or plastics. The tissue anchors 260, 261 may be blunt or sharp.

[0197] Similar to the mechanical connector 250, the one or more tissue anchors 260, 261 may comprise one or more of a superelastic material, a pseudoelastic material, a shape memory material, titanium, stainless steel, surgical stainless steel, cobalt-chromium, nickel-titanium alloy (nitinol), platinum, tungsten, silver, gold, tantalum, iridium, or alloys thereof, or any combination thereof.

[0198] The tissue anchors 260, 261 may be attached to the magnetic elements 210, 211 using any suitable means, such as welding, laser welding, adhesive and / or glue. Attachment may be at any suitable location, such as along one of the ends and / or sides of the magnetic elements 210, 211.

[0199] Additionally or alternatively, one or more tissue anchors 260, 261 may be highly integrated with one or more mechanical connectors 250.

[0200] When a housing 230 is used to enclose one or more magnetic elements 210, 211, tissue anchors 260, 261 may be attached to one or more suitable positions on the housing 230 and / or to one or more suitable positions on the permanent magnet 220.

[0201] The tissue anchors 260, 261 may be pre-formed to provide a predetermined anchor shape, may be folded after implantation, may be configured to fold after implantation, or some combination thereof.

[0202] For example, if tissue anchor 260, 261 comprises spring steel, it may be configured and arranged to retain the implanted shape and / or orientation depicted in Figures 8B, 8C, or 8D. Tissue anchor 260, 261 may further be configured and arranged to adopt a substantially flattened shape and / or orientation, as depicted in Figure 8A, prior to and / or during implantation, whereby magnetic markers 203, 206 may be inserted into bore 400b of implantation channel 400.

[0203] Alternatively, tissue anchors 260, 261 may be constructed and arranged to retain the substantially flattened, laid-out configuration depicted in Figure 8 A. After implantation, a force or suitable delivery of energy may be applied to cause them to adopt the implanted shape and / or orientation depicted in Figures 8B, 8C, or 8D.

[0204] Figures 9A, 9B, and 9C depict, in longitudinal cross section, a schematic of how the magnetic marker 203 depicted in Figure 8 may be implanted. The implantation of the magnetic marker 206 depicted in Figure 8D may be implanted in a similar manner. These figures depict possible static situations of the dynamic implantation process.

[0205] 9A, the magnetic marker 203 is arranged within an inner bore 400b of an implantation channel 400, such as a hollow injection needle. The marker implantation volume can thus be considered to have a longitudinal implantation extent equal to the longitudinal bore extent (not depicted), a first lateral extent equal to the first lateral bore extent 400b, and a second lateral extent equal to the second lateral bore extent (not depicted).

[0206] From left to right, Figure 9A depicts first mechanical anchor 260(###) and second mechanical anchor 261(###), first magnetic element 210, mechanical connector 250, and second magnetic element 211. Second magnetic element 211 is closest to the opening of the implantation channel (depicted on the right) and appears first during implantation. Mechanical anchors 260, 261 extend longitudinally substantially flat (substantially retracted).

[0207] In other words, the magnetic marker 200 includes: ###

[0210] ==

[0211] ⇒(Opening)

[0208] A suitable bore for the channel 400 may have an inner diameter slightly larger than the maximum lateral extent of the magnetic marker 203 (not depicted in FIG. 9), provided that: - the second orientation angle (not depicted in Figure 9) is preferably in the range of 160-200 degrees, most preferably about 180 degrees; and - during implantation, if the lateral extent of the tissue anchors 260, 261 is less than or equal to the maximum lateral extent of the magnetic elements 210, 211; The size of the hole 400b may be determined primarily using the maximum lateral extent (or diameter) of the two or more magnetic elements 210, 211 (not depicted).

[0209] 9B depicts the emergence of the first magnetic element, mechanical connector 250, and second magnetic element from the opening of the implantation channel 400 during implantation.

[0211] =.

[0210] =' appears.

[0210] In this case, the mechanical connector 250 is constructed and arranged to allow the first longitudinal plane 270 and the second longitudinal plane 271 to be approximately parallel. This equates to an orientation angle between the first longitudinal plane 270 and the second longitudinal plane 271 being approximately 0 degrees. In this case, this is the embedded orientation of the magnetic elements 210, 211 (as depicted in FIG. 8B ). However, the mechanical anchors 260, 261 have not yet been deployed.

[0211] 9C depicts the completion of implantation, where the tissue anchors 260, 261 have been deployed. #

[0211] =. #

[0210] =' # appears and unfolds.

[0212] After emerging from the opening of the embedding channel 400, the mechanical anchors 260, 261 can adopt their first anchor shape and / or first anchor orientation relative to the magnetic marker 203, as depicted in FIG. 8B . In this example, the first anchor shape is approximately semicircular. Also in this example, the first anchor orientation is aligned in a lateral plane through the first magnetic element 210 and the second magnetic element 211. Also in this example, the maximum lateral embedded extent 203e is determined by the vertical distance along the lateral plane between the outer edge of the first mechanical anchor 260 and the outer edge of the second mechanical anchor 261.

[0213] For example, assuming the magnetic elements 210, 211 are similar or identical, the orientation angle 280 during implantation is about 180 degrees as depicted in FIGS. 8A and 9A , and the mechanical anchors 260, 261 lie flat and do not have significant differences in orientation along the second lateral extent: - Longitudinal embedding extent 203a = approximately longitudinal extent of mechanical anchor + (2x longitudinal extent of magnetic element) + longitudinal extent of mechanical connector, and lateral embedding extent 203b = approximately (1x maximum lateral extent of magnetic element).

[0214] After implantation, assuming the magnetic element configuration and mechanical anchor placement depicted in FIGS. 8B and 8C are compact, and assuming there is no significant difference in orientation along the second lateral extent (as depicted in FIG. 8C ), - longitudinal embedded extent 203d = approximately (1 x longitudinal extent of magnetic element) + (0.5 x longitudinal extent of mechanical connector) + (0.5 x longitudinal extent of mechanical anchor), and transverse embedded extent 203e = approximately (2 x 0.5 x longitudinal extent of mechanical anchor).

[0215] this is, - a large increase in the lateral embedded extent 203e of about (1 x longitudinal extent of the mechanical anchor) - (1 x maximum lateral extent of the magnetic element), and - represents a large reduction in longitudinal embedded extent 203d of approximately (0.5 x longitudinal extent of mechanical anchor) + (1 x longitudinal extent of magnetic element) + (0.5 x longitudinal extent of mechanical connector).

[0216] It may be particularly advantageous if one or more tissue anchors 260, 261 comprise one or more of (superelastic materials, pseudoelastic materials, shape memory materials, Nitinol, Fe—Mn—Si, Cu—Zn—Al, and Cu—Al—Ni) or any combination thereof, which may be able to temporarily adopt an implanted (retracted) orientation (e.g., in FIG. 9A ) and / or automatically adopt an implanted (deployed) orientation (e.g., in FIG. 9C ).

[0217] Optionally, each mechanical anchor 260, 261 comprises: - assume a second anchor shape and / or a second anchor orientation relative to the magnetic marker 203 (not depicted) during implantation; and / or may be configured and arranged to assume a further anchor shape and / or a further anchor orientation relative to the magnetic marker 203 prior to implantation. Additionally or alternatively, this may be all or part of a second anchor shape and / or second anchor orientation; and / or - may be configured and arranged to apply a force against the inner surface of the hole 400b during implantation, thereby significantly increasing the resistance to movement of the magnetic markers 203, 206 during implantation. This may be advantageous to prevent unwanted deployment of the implantable magnetic markers 203, 206 during implantation, for example by configuring and arranging the one or more mechanical anchors 260, 261 to expand laterally during implantation.

[0218] Each mechanical anchor 260, 261 contained within magnetic marker 203 may be configured and arranged to provide the same, similar, or different anchor shapes and / or anchor orientations. Each mechanical anchor 260, 261 may be oriented along the same or different longitudinal planes. Each mechanical anchor 260, 261 may be oriented along the same or different transverse planes.

[0219] 13A-13I depict several schematic plan views of additional embodiments of implantable magnetic markers 207A-I, including one or more additional instances of mechanical anchors 262A-I configured and arranged as one or more tissue anchors 262A-I. While depicted as rectangular, each magnetic marker 207A-I may include one or more magnetic elements and one or more mechanical connectors, and mechanical anchors 262A-I may be securely attached to any element, connector, or housing in any position or orientation, or any combination thereof. Each depicted mechanical anchor 262A-I and any components thereof may be utilized individually or in combination.

[0220] The mechanical anchor is the same as the anchor described above in connection with FIGS. 8A-8D, with the following exceptions.

[0221] FIG. 13A depicts a magnetic marker 207A including one or more bristles 262A arranged at one or more locations on the magnetic marker 207A. These bristles 262A may be regularly or irregularly spaced over a portion of the magnetic marker 207A. Optionally, multiple bristles may be clustered together as shown in FIG. 13A. Any type of bristles 262A may be used, including, but not limited to, bristles having a fractal-like fiber shape. The length, stiffness, and distribution of the bristles 262A may be predetermined and / or controlled to provide a desired range of adhesion.

[0222] FIG. 13B depicts magnetic marker 207B, which includes one or more expandable mechanical anchors 262B. In at least some embodiments, magnetic marker 207B may be implanted using an embedding channel (not depicted) with an appropriate bore (or inner diameter). Prior to and / or during implantation, magnetic marker 207B is inserted into the embedding channel, which surrounds mechanical anchor 262B. During implantation, mechanical anchor 262B recesses laterally toward magnetic marker 207B; in the case of a circular cross-section, mechanical anchor 262B may recess radially. When the embedding channel is removed, mechanical anchor 262B expands into nearby tissue. In at least one embodiment, mechanical anchor 262B has a spring-like property that results in expansion of mechanical anchor 262B when the embedding channel is removed. When more than one mechanical anchor 262B is provided, the more than one mechanical anchor 262B may be distributed in a regular or irregular pattern around the body of the magnetic marker 207B.

[0223] 13C depicts a magnetic marker 207C including one or more mechanical barbs 262C extending from one or more locations on the magnetic marker 207C. The mechanical barbs 262C may be suspended in the surrounding tissue to provide a high degree of anchoring. In some embodiments, the ends of the mechanical barbs 262C may comprise one or more relatively rigid materials, while the remainder of the mechanical barbs 262C may comprise one or more flexible materials. This may allow the mechanical barbs 262B to be recessed laterally toward the magnetic marker 207C for insertion into an implantation channel (not depicted), or in the case of a circular cross-section, the mechanical barbs 262B may be recessed radially.

[0224] 13D depicts a magnetic marker 207D including one or more mechanical tines 262D extending from the magnetic marker 207D at an angle substantially less than 90 degrees. One or more mechanical tines 262D may be provided distributed in any regular or irregular pattern, including, but not limited to, one or more ring-like arrangements around the magnetic marker 207D.

[0225] 13E depicts a magnetic marker 207E including one or more mechanical pins 262E rigidly attached to the longitudinal ends of the magnetic marker 207E. The mechanical pins 262E may have any suitable shape, such as a spiral (as depicted), a whorl, a corkscrew, or the like. In one embodiment, the mechanical pins 262E may be configured and arranged to be rotatable about their longitudinal axis during or after implantation in order to thread the mechanical pins 262E into tissue.

[0226] 13F depicts a magnetic marker 207F that includes shaped mechanical tips 262F at the longitudinal ends of the magnetic marker 207F that allow for some tissue ingrowth between one or more portions of the mechanical tips 262F or between the mechanical tips 262F and the body of the magnetic marker 207F. Preferably, the shaped mechanical tips 262F comprise a material that is flexible enough to be forced through the holes of the implantation channel (not depicted), yet also rigid enough to provide a high degree of anchoring after tissue ingrowth.

[0227] 13G depicts a magnetic marker 207G including one or more mechanical hooks (or barbs) 262G extending from one or more locations on the magnetic marker 207G. The mechanical hooks 262G may be suspended in the surrounding tissue for enhanced anchoring. In some embodiments, the ends of the mechanical hooks 262G may comprise one or more relatively rigid materials, while the remainder of the mechanical hooks 262G may comprise one or more flexible materials. This may allow the mechanical barbs 262G to be recessed laterally toward the magnetic marker 207G for insertion into an implantation channel (not depicted); in the case of a circular cross-section, the mechanical barbs 262G may be recessed radially.

[0228] 13H depicts a magnetic marker 207H including one or more mechanical springs 262H rigidly attached at the longitudinal ends of the magnetic marker 207H. The mechanical springs 262H may have any suitable shape, such as a helix (as depicted), a spiral, a corkscrew, a serpentine, or the like. In one embodiment, the mechanical springs 262H may be configured and arranged to be rotatable about a longitudinal axis during or after implantation to thread the mechanical pins 262H into tissue.

[0229] 131 depicts a magnetic marker 2071 that includes one or more mechanical loops 2621 at one or more longitudinal ends of the magnetic marker 2071 that allow for some tissue ingrowth within the one or more mechanical loops 2621. Preferably, the shaped mechanical loops 2621 comprise a material that is flexible enough to be forced through the holes of the implantation channel (not depicted), yet also rigid enough to provide a high degree of anchoring after tissue ingrowth.

[0230] Figures 4A, 4B, and 4C depict a further embodiment of an implantable magnetic marker 201. Figure 4A depicts a schematic plan view of the magnetic marker 201 before and / or during implantation. Figures 4B and 4C depict schematic plan views of the magnetic marker 201 after implantation. The marker 201 is the same as that described above in connection with Figures 2A, 2B, 2C, and 2D, with the following exceptions: As depicted in Figure 4A, before and / or during implantation, the magnetic marker 201 has a marker volume with a longitudinal extent 201a, a first lateral extent 201b and a second lateral extent (not depicted), which may be the same, similar or different compared to the respective extents 200a, 200b depicted in Figure 2A; As depicted in Figure 4B, after implantation, the magnetic marker 201 has an embedded marker volume with an embedded longitudinal extent 201d, a first lateral extent 201e and a second lateral extent (not depicted), which may be identical, similar or different compared to the respective extents 200d, 200e depicted in Figure 2C(i); As depicted in Figure 4C, after implantation, the magnetic marker 201 has an embedded marker volume with an embedded longitudinal extent (not depicted), a first lateral extent 201e and a second lateral extent 201f, which may be identical, similar or different compared to the respective extents 200e, 200f depicted in Figure 2C(ii); Additionally, the magnetic marker 201 comprises a further magnetic element 212 arranged along a further central longitudinal plane 272 and including a permanent magnet with a further north pole and a further south pole; a further mechanical connector 251 extending between the further magnetic element 212 and the second magnetic element 211, the further mechanical connector 251 comprising: - when deployed (arranged in human or animal tissue), resiliently retain a further first orientation (not depicted) between the further longitudinal plane and the second longitudinal plane 271; a mechanical connector 251 configured and arranged to assume a further second orientation (not depicted) between the further longitudinal plane and the second longitudinal plane 271 during implantation; The ranges 201a, 201b and the second lateral range (not depicted) may also be determined by the further magnetic element 212, the further magnetic connector 251 and the orientation between the further magnetic element 212 and the second magnetic element 211.

[0231] The magnetic marker 201 includes:

[0210] ==

[0211] ==

[0212]

[0232] In general, the further magnetic connector 251 may be configured and arranged to be substantially the same as the first mechanical connector 250, similar to the first mechanical connector 250, or substantially different from the first mechanical connector 250.

[0233] In embodiments of the magnetic marker that generally include three or more magnetic elements 210, 211, 212, the mechanical connectors 250, 251 may be configured to allow the two outer magnetic elements 210, 212 to be folded toward the central magnetic element 211 to reduce the embedded longitudinal extent of the marker.

[0234] In this embodiment 201, the maximum lateral extent 201ef after implantation (as depicted in Figures 4B and 4C) is reduced by configuring an additional mechanical connector 251 to align the additional magnetic element 212 with both the first magnetic element 210 and the second magnetic element 211 in a stacked arrangement. As depicted in Figure 4C, when viewed end-on along the longitudinal plane, the magnetic elements 210, 211, 212 appear to be arranged in a triangular orientation relative to one another.

[0235] Further reduction in maximum lateral extent 201ef may be possible by using magnetic elements with interlocking cross sections such as triangular, square or polygonal.

[0236] Additionally, as depicted, the longitudinal planes containing the magnetic elements 210, 211, 212 may be substantially parallel, and as noted above, although this is not required, substantially parallel or a small angle of orientation is preferred.

[0237] 5A, 5B, 5C, 5D and 5E schematically depict how the magnetic marker 201 depicted in FIG. 4 may be embedded.

[0238] 5A depicts a longitudinal cross section through marker 201 arranged within inner bore 400b of implantation channel 400. The marker implantation volume can thus be considered to have a longitudinal implantation extent equal to the longitudinal bore extent (not depicted), a first lateral extent equal to first lateral bore extent 400b, and a second lateral extent equal to second lateral bore extent (not depicted).

[0239] From left to right, Figure 5A depicts a first magnetic element 210, a first mechanical connector 250, a second magnetic element 211, an additional mechanical connector 251, and an additional magnetic element 212. The additional magnetic element 212 is closest to the opening of the implantation channel (depicted on the right) and appears first during implantation.

[0240] Also depicted are the magnetic poles, i.e., from left to right (arranged along the longitudinal plane): the north and south poles of the first magnetic element 210, the south and north poles of the second magnetic element 211, and the north and south poles of the further magnetic element 212. A further mechanical connector 251 extends between the north pole of the second magnetic element 211 and the north pole of the further magnetic element 212. A first mechanical connector 250 extends between the south pole of the second magnetic element 211 and the south pole of the first magnetic element 210.

[0241] In other words, the magnetic marker 201 includes: [N 210 S]==[S 211 N]==[N 212 S]⇒(opening)

[0242] As depicted in FIG. 5A, the north poles of the further magnetic element 212 and the second magnetic element 211 are held closer together by the further mechanical connector 251, and the south poles of the first magnetic element 210 and the second magnetic element 211 are held closer together by the first mechanical connector 250.

[0243] The mechanical connectors 250, 251 thus overcome the repulsive magnetic forces to allow for a predetermined and / or controlled configuration and / or placement prior to and / or during implantation.

[0244] A suitable bore 400b of the channel 400 may have an inner diameter slightly larger than the maximum lateral extent (not depicted in FIG. 5A) of the magnetic marker 201. The size of the bore 400b may be primarily determined using the maximum lateral extent (or diameter) (not depicted) of the three or more magnetic elements 210, 211, 212, where the second orientation angle 280 (not depicted in FIG. 5A) is preferably in the range of 160-200 degrees, and most preferably about 180 degrees.

[0245] 5B depicts the emergence of an additional magnetic element 212 and an additional mechanical connector 251 from the opening of the implantation channel 400 during implantation. In other words, "==[N 212 S]" emerges.

[0246] In this case, the further mechanical connector 251 is constructed and arranged such that the orientation angle (not depicted) between the further longitudinal plane 272 and the second longitudinal plane 271 can be approximately 90 degrees, which in this case is an intermediate orientation angle between the embedded orientation (depicted in FIG. 5A) and the buried orientation (depicted in FIG. 5E).

[0247] As depicted, the north poles of the further magnetic element 212 and the second magnetic element 211 are also held more proximally by the further mechanical connector 251, which thus overcomes the repulsive magnetic forces to allow for a predetermined and / or controlled configuration and / or arrangement after implantation.

[0248] 5C and 5D depict the emergence of the second magnetic element 211 from the buried channel 400 during implantation. In other words, "==[S 211 N]==" emerges.

[0249] In this case, mechanical connector 250 is constructed and arranged such that the orientation angle (not depicted) between first longitudinal plane 270 and second longitudinal plane 271 can be approximately 90 degrees (depicted in FIG. 5D), which in this case is an intermediate orientation angle between the buried orientation (depicted in FIG. 5A) and the embedded orientation (depicted in FIGS. 4B, 4C, and 5E).

[0250] As depicted, the south poles of first magnetic element 210 and second magnetic element 211 are also held more proximally by mechanical connector 250. Mechanical connector 250 thus overcomes the repulsive magnetic forces to allow for a predetermined and / or controlled configuration and / or placement after implantation.

[0251] FIG. 5E depicts the completion of implantation. In other words, "[N 210 S]==" appears. The mechanical connector 250 allows the orientation angle between the first longitudinal plane 270 and the second longitudinal plane 271 to adopt and maintain its implanted orientation. In this case, the first longitudinal plane 270 and the second longitudinal plane 271 are substantially parallel. This is substantially the same orientation as the orientation angle (not depicted in FIG. 5E), which is approximately 0 degrees. The implanted configuration and arrangement are also depicted in FIGS. 4B and 4C.

[0252] As depicted, the south poles of magnetic elements 210, 211, and 212 (not visible in FIG. 5E) are held in close proximity by mechanical connectors 250, 251, and the north poles of the magnetic elements are also held in close proximity by mechanical connectors 250, 251. Mechanical connectors 250, 251 overcome the repulsive magnetic forces, thus allowing for a predetermined and / or controlled configuration and / or arrangement. In other words, the implanted configuration and arrangement may be schematized as follows: .=[N 211 S]=. '=[N 212 S]| [N 210 S]='

[0253] For example, assuming that the magnetic elements 210, 211, 212 are similar or identical, and the orientation angle during implantation is about 180 degrees as depicted in FIGS. 4A and 5A, and there is no significant difference in orientation along the second lateral extent, - Longitudinal embedding extent 201a = approximately (3 x longitudinal extent of magnetic element) + (2 x longitudinal extent of mechanical connector), and lateral embedding extent 201b = approximately (1 x maximum lateral extent of magnetic element).

[0254] Assuming that after implantation, the configurations and arrangements depicted in FIGS. 4B, 4C, and 5E are compact or have an orientation angle of about 0 degrees, and assuming there is no significant difference in orientation along the second lateral extent 201f: - The longitudinal embedded extent 201d = approximately (1 x longitudinal extent of magnetic element) + (2 x 0.5 x longitudinal extent of mechanical connector) and the lateral embedded extent 201ef = approximately (2 x maximum lateral extent of magnetic element).

[0255] this is, - represents a large increase in the lateral embedded extent 201ef of approximately (1x the lateral extent of the maximum magnetic element) and a large reduction in the longitudinal embedded extent 201d of approximately (2x the longitudinal extent of the magnetic element) + (1x the longitudinal extent of the mechanical connector).

[0256] 11A, 11B, and 11C depict a further embodiment of an implantable magnetic marker 205. FIG. 11A depicts a schematic plan view of the magnetic marker 205 before and / or during implantation. FIGs. 11B and 11C depict schematic plan views of the magnetic marker 205 after implantation. The marker 205 is the same as that described above in connection with FIGS. 4A, 4B, and 4C, with the following exceptions: As depicted in Figure 11A, the magnetic marker 205 has a marker volume with a longitudinal extent 205a, a first lateral extent 205b and a second lateral extent (not depicted), which extents 205a, 205b may be identical, similar or different compared to the respective extents 201a, 201b depicted in Figure 4A; As depicted in Figure 11B, after implantation, the magnetic marker 205 has an embedded marker volume with an embedded longitudinal extent 205d, a first lateral extent 205e, and a second lateral extent (not depicted), which may be identical, similar, or different compared to the respective extents 201d, 201e depicted in Figure 4B; As depicted in Figure 11C, after implantation, the magnetic marker 205 has an embedded marker volume with an embedded longitudinal extent (not depicted), a first lateral extent 205e, and a second lateral extent 205f, which may be identical, similar, or different compared to the respective extents 201e, 201f depicted in Figure 4C; In this embodiment, the first magnetic element 1210 and the further magnetic element 1212 have a relatively small longitudinal extent, which is substantially smaller (shorter) than the longitudinal extent of the central second magnetic element 211.

[0257] The magnetic marker 205 includes:

[1210] ==

[0211] ==

[1212]

[0258] As described with respect to Figure 4, the mechanical connectors 250, 251 may be configured to allow the two outer magnetic elements 1210, 1212 to be folded towards the central second magnetic element 211 to reduce the embedded longitudinal extent 205d of the marker. However, by using shorter outer magnetic elements 1210, 1212, it may be possible to achieve a smaller increase in maximum lateral extent 205ef compared to the marker 201 of Figure 4.

[0259] A minimal increase in maximum lateral extent 205ef may be provided when the further longitudinal plane 272 and the first longitudinal plane 270 are substantially coincident and the ends of the further magnetic element 1212 and the first magnetic element 1210 having opposite magnetic polarities are held proximate. For example, the longitudinal extent of the first magnetic element 1210 and the further magnetic element 1212 may be approximately half the longitudinal extent of the second magnetic element 211.

[0260] Additionally, by using the attraction due to the opposite polarities of the magnetic elements 1210, 1212 at reduced range, the risk of incorrect or insufficient deployment of the magnetic marker 205 may be reduced.

[0261] 12A, 12B, and 12C schematically depict how the magnetic marker 205 depicted in FIG. 11 may be implanted.

[0262] 12A depicts a longitudinal cross section through marker 205 arranged within inner bore 400b of implantation channel 400. The marker implantation volume can thus be considered to have a longitudinal implantation extent equal to the longitudinal bore extent (not depicted), a first lateral extent equal to first lateral bore extent 400b, and a second lateral extent equal to second lateral bore extent (not depicted).

[0263] From left to right, Figure 12A depicts a shorter first magnetic element 1210, a first mechanical connector 250, a second magnetic element 211, an additional mechanical connector 251, and a shorter additional magnetic element 1212. The shorter additional magnetic element 1212 is closest to the opening of the implantation channel (depicted on the right) and appears first during implantation.

[0264] Also depicted are the magnetic poles, i.e., from left to right (arranged along the longitudinal plane): the south and north poles of the shorter first magnetic element 1210, the north and south poles of the second magnetic element 211, and the south and north poles of the shorter further magnetic element 1212. A further mechanical connector 251 extends between the south pole of the second magnetic element 211 and the south pole of the shorter further magnetic element 1212. A first mechanical connector 250 extends between the north pole of the second magnetic element 211 and the north pole of the shorter first magnetic element 1210.

[0265] In other words, the magnetic marker 205 includes: [S 1210 N]==[N 211 S]==[S 1212 N]⇒(opening)

[0266] As depicted in FIG. 12A, the north poles of the shorter first magnetic element 1210 and second magnetic element 211 are held closer together by a first mechanical connector 250, and the south poles of the shorter further magnetic element 1212 and second magnetic element 211 are held closer together by a further mechanical connector 251.

[0267] A suitable hole 400b in the channel 400 may have an inner diameter slightly larger than the maximum lateral extent (not depicted in FIG. 12A) of the magnetic marker 205. The size of the hole 400b may be primarily determined using the maximum lateral extent (or diameter) (not depicted) of the three or more magnetic elements 1210, 211, 1212, where the second orientation angle (not depicted in FIG. 12A) is preferably in the range of 160-200 degrees, and most preferably about 180 degrees.

[0268] 12B depicts the emergence of the second magnetic element 211 and the further magnetic element 1212 from the opening of the buried channel 400 during implantation. In other words, ==[N 211 S]==[S 1212 N] emerges.

[0269] In this case, the further mechanical connector 251 is constructed and arranged such that the orientation angle (not depicted) between the further longitudinal plane 1272 and the second longitudinal plane 271 can adopt its embedded orientation.

[0270] As depicted, the south pole of the further magnetic element 1212 and the second magnetic element 211 are also held more proximally by a further mechanical connector 251 .

[0271] Figure 12C depicts the completion of the embedding. In other words, "[S 1210 N]==" appears.

[0272] The mechanical connector 250 allows the orientation angle between the first longitudinal plane 1270 and the second longitudinal plane 271 to adopt and maintain its embedded orientation. In this case, the first longitudinal plane 1270, the second longitudinal plane 271, and the further longitudinal plane 1272 are substantially parallel. This is substantially the same orientation as the orientation angle (not depicted in FIG. 12C) being about 0 degrees. The embedded configuration and arrangement is also depicted in FIGS. 11B and 11C.

[0273] Additionally, the further longitudinal plane 1272 and the second longitudinal plane 271 are substantially coincident and the ends of the further magnetic element 1212 and the first magnetic element 1210 having opposite polarities are held proximate.

[0274] As depicted, the south poles of magnetic elements 211 and 1212 are held in close proximity by a further mechanical connector 251 and the north poles of magnetic elements 1210 and 211 are held in close proximity by a first mechanical connector 250.

[0275] Additionally, the ends of the shorter further magnetic element 1212 and the shorter first magnetic element 1210 are held in close proximity by the attractive force between the north and south poles without a mechanical connector.

[0276] In other words, the embedded configuration and arrangement can be diagrammed as follows: .=[S 1210 N][S 1212 N]=. '=[N 211 S]='

[0277] For example, assuming that the shorter magnetic elements 1210, 1212 are similar or identical, the second (longer) magnetic element 211 has a similar lateral extent and twice the longitudinal extent, and the orientation angle during implantation is about 180 degrees (as depicted in FIGS. 11A and 12A), and there is no significant difference in orientation along the second lateral extent: - longitudinal embedding extent 205a = approximately (1 x longitudinal extent of longer magnetic element) + (2 x 0.5 x longitudinal extent of shorter magnetic element) + (2 x longitudinal extent of mechanical connector), and lateral embedding extent 205b = approximately (1 x lateral extent of largest magnetic element).

[0278] After implantation, assuming the configurations and arrangements depicted in FIGS. 11B, 11C, and 12C are compact or have an orientation angle of about 0 degrees, and assuming there is no significant difference in orientation along the second lateral extent 205f, - The longitudinal embedded extent 205d = approximately (2 x 0.5 x longitudinal extent of the shorter magnetic element) + (2 x 0.5 x longitudinal extent of the mechanical connector), and the lateral embedded extent 205e = approximately (2 x lateral extent of the largest magnetic element).

[0279] this is, - represents a large increase in the lateral embedded extent 205e of about (1 x the lateral extent of the maximum magnetic element) and a large reduction in the longitudinal embedded extent 205d of about (1 x the longitudinal extent of the longer magnetic element) + (1 x the longitudinal extent of the mechanical connector).

[0280] Figures 6A, 6B, and 6C depict a further embodiment 202 of an implantable magnetic marker. Figure 6A depicts a schematic plan view of the magnetic marker 202 before and / or during implantation. Figures 6B and 6C depict schematic plan views of the magnetic marker 202 after implantation. The marker 202 is the same as that described above in connection with Figures 4A, 4B, and 4C, except as follows: as depicted in Figure 6A, the magnetic marker 202 has a marker volume with a longitudinal extent 202a, a first lateral extent 202b, and a second lateral extent (not depicted). These extents 202a, 202b may be the same, similar, or different from the respective extents 201a, 201b depicted in Figure 4A. As depicted in Figure 6B, after implantation, the magnetic marker 202 has an embedded marker volume with an embedded longitudinal extent 202d, a first lateral extent 202e, and a second lateral extent (not depicted), which may be identical, similar, or different compared to the respective extents 201d, 201e depicted in Figure 4B; As depicted in Figure 6C, after implantation, the magnetic marker 202 has an embedded marker volume with an embedded longitudinal extent (not depicted), a first lateral extent 202e, and a second lateral extent 202f, which may be identical, similar, or different compared to the respective extents 201e, 201f depicted in Figure 4C; the magnetic marker 202 is arranged along an additional further longitudinal plane (not depicted) and includes an additional further magnetic element 213, the additional further magnetic element 213 including a permanent magnet with an additional north pole and an additional south pole; and an additional further mechanical connector 252 extending between the additional further magnetic element 213 and the additional further magnetic element 212, the additional further mechanical connector 252 - when deployed, resiliently retain an additional further first orientation (not depicted) between the additional further longitudinal plane (not depicted) and the additional longitudinal plane 272; - also including an additional further mechanical connector 252 between the buried channels, configured and arranged to assume an additional further second orientation (not depicted) between the additional further longitudinal plane (not depicted) and the additional further longitudinal plane 272; - The ranges 202a, 202b and the second lateral range (not depicted) may also be determined by the outer edge of the additional further magnetic element 213, the additional further mechanical connector 252 and the orientation between the additional magnetic element 212 and the additional further magnetic element 213.

[0281] The magnetic marker 202 includes:

[0210] ==

[0211] ==

[0212] ==

[0213]

[0282] In general, the additional further mechanical connector 252 may be configured and arranged to be substantially the same as the first mechanical connector 250, similar to the first mechanical connector 250, or substantially different from the first mechanical connector 250. Additionally or alternatively, the additional further mechanical connector 252 may be configured and arranged to be substantially the same as the further mechanical connector 251, similar to the further mechanical connector 251, or substantially different from the further mechanical connector 251.

[0283] In magnetic marker embodiments that generally include four or more magnetic elements 210, 211, 212, 213, the mechanical connectors 250, 251, 252 may be configured to allow adjacent magnetic elements 210, 211, 212, 213 to fold toward each other to reduce the embedded longitudinal extent of the marker.

[0284] In this embodiment 202, the maximum lateral extent 202ef, after implantation (as depicted in Figures 6B and 6C), is: an additional further mechanical connector 252 for arranging the additional further magnetic element 213 relative to both the second magnetic element 211 and the further magnetic element 212 in a stacked arrangement; - further reduced by configuring the first mechanical connector 250 to align the first magnetic element 210 with both the second magnetic element 211 and the further magnetic element 212 on the opposite side of the stacked arrangement.

[0285] When viewed end-on along the longitudinal plane as depicted in FIG. 6C, the magnetic elements 210, 211, 212, 213 appear to be arranged in a diamond-shaped orientation relative to one another.

[0286] Further reduction in maximum lateral extent 202ef may be possible by using magnetic elements with interlocking cross sections such as triangular, square or polygonal.

[0287] Additionally, as depicted, the longitudinal planes containing the magnetic elements 210, 211, 212, 213 may be substantially parallel, i.e., as noted above, this is not required, although substantially parallel or a small angle of orientation is preferred.

[0288] The embedding may be done in a similar manner to the magnetic marker 201 described above in connection with FIGS.

[0289] For example, assuming that the magnetic elements 210, 211, 212, 213 are similar or identical, and the orientation angle during implantation is about 180 degrees as depicted in FIG. 6A, and there is no significant difference in orientation along the second lateral extent, - Longitudinal embedding extent 202a = approximately (4 x longitudinal extent of magnetic element) + (3 x longitudinal extent of mechanical connector), and lateral embedding extent 202b = approximately (1 x lateral extent of largest magnetic element).

[0290] Assuming that after implantation, the configurations and arrangements depicted in FIGS. 6B and 6C are compact or have an orientation angle of about 0 degrees, and assuming there is no significant difference in orientation along the second lateral extent 202f, - The longitudinal embedded extent 202d = approximately (1 x longitudinal extent of magnetic element) + (2 x 0.5 x longitudinal extent of mechanical connector), and the lateral embedded extent 202f = approximately (3 x maximum lateral extent of magnetic element).

[0291] this is, - represents a large increase in the lateral embedded extent 202f of approximately (2x the maximum lateral extent of the magnetic element) and a large reduction in the longitudinal embedded extent 202d of approximately (3x the longitudinal extent of the magnetic element) + (2x the longitudinal extent of the mechanical connector).

[0292] The implantable magnetic markers may alternatively be summarized as follows: Implantable magnetic markers for providing a detectable magnetic field, the markers 200, 201, 202, 203, 204, 205, 206, 207 comprising: a first magnetic element 210, 211, 212, 213, 1210, 1212 comprising a permanent magnet 220 with a first north pole 240 and a first south pole 245; a second magnetic element 210, 211, 212, 213, 1210, 1212 comprising a permanent magnet 220 with a second north pole 241 and a second south pole 246; - mechanical connectors 250, 251, 252 extending between the first magnetic element 210 and the second magnetic element 211, the mechanical connectors 250, 251, 252 being - elastically maintaining a first orientation 280 between the first magnetic element 210, 211, 212, 213, 1210, 1212 and the second magnetic element 210, 211, 212, 213, 1210, 1212 when arranged in human or animal tissue, wherein the magnetic markers 200, 201, 202, 203, 204, 205, 206, 207 are surrounded by an embedded marker volume with longitudinally embedded extents 200d, 201d, 202d, 203d, 204d, 205d, 206d and laterally embedded extents 200ef, 201ef, 202ef, 203ef, 204e, 205ef, 206e; - configured and arranged to assume, prior to and / or during implantation, a second orientation 280 between the first magnetic element 210, 211, 212, 213, 1210, 1212 and the second magnetic element 210, 211, 212, 213, 1210, 1212, whereby the magnetic markers 200, 201, 202, 203, 204, 205, 206, 207 are surrounded by an implantation volume with a longitudinal implantation extent 400a and a lateral implantation extent 400b, The laterally embedded areas 200ef, 201ef, 202ef, 203ef, 204e, 205ef, 206e are significantly larger than the laterally embedded area 400b, and the longitudinally embedded areas 200d, 201d, 202d, 203d, 204d, 205d, 206d are significantly smaller than the longitudinal embedded area 400a, including the mechanical connectors 250, 251, 252.

[0293] Optionally, in such an implantable magnetic marker, the first and / or second permanent magnetic elements 210, 211, 212, 213, 1210, 1212 may include a housing 230 with a cavity, enclosing a permanent magnet 220 within said cavity.

[0294] Optionally, in such an implantable magnetic marker, one or more housings 230 may be constructed and arranged to substantially enclose the permanent magnet (220) within said cavity.

[0295] Optionally, in such an implantable magnetic marker, the housing 230 may include multiple housing parts attached together to form the outer wall of the housing 230, enclosing the permanent magnet 220 within the cavity.

[0296] Optionally, in such an implantable magnetic marker, the housing 230 may include a longitudinally extending hollow sleeve and / or two end caps.

[0297] Additionally or alternatively, the mechanical connectors 250 , 251 , 252 may be attached to the outer surface of the permanent magnets 220 contained within the first magnetic element 210 and / or the second magnetic element 211 .

[0298] Additionally or alternatively, mechanical connectors 250, 251, 252 may extend between ends of the first magnetic element 210 and the second magnetic element 211 that have the same or opposite polarities. Optionally, the ends of the first magnetic element 210 and the second magnetic element 211 that have opposite polarities may be maintained at a predetermined and / or controlled separation.

[0299] Additionally or alternatively, implantable magnetic markers 203, 204, 207 may further include one or more mechanical anchors 260, 261, 262 configured and arranged to resist changes in position of the one or more magnetic elements when placed within human or animal tissue. Optionally, one or more mechanical anchors 260, 261, 262 may be configured and arranged to extend laterally during implantation.

[0300] Additionally or alternatively, the embedded magnetic markers 201, 202, 205 may be: - a further magnetic element comprising a permanent magnet 220 with a further north pole and a further south pole; a further mechanical connector 251, 252 extending between the further magnetic element and the second magnetic element, the further mechanical connector 251, 252 - resiliently maintaining a further first orientation between the further magnetic element and the second magnetic element when disposed within human or animal tissue; - further mechanical connectors 251, 252 configured and arranged to provide a further second orientation between the further magnetic element and the second magnetic element prior to and / or during implantation.

[0301] Optionally, the first magnetic element and the further magnetic element may have a longitudinal extent that is substantially smaller than a longitudinal extent of the second magnetic element.

[0302] Additionally or alternatively, the magnetic marker 205 may be configured and arranged such that the ends of the further magnetic element 1212 and the first magnetic element 1210, having opposite polarities, are held at a predetermined and / or controlled closer proximity.

[0303] The method for embedding magnetic markers may alternatively be summarized as follows: A method for embedding implantable magnetic markers, the magnetic markers 200, 201, 202, 203, 204, 205, 206, 207 comprising: a first magnetic element 210, 211, 212, 213, 1210, 1212 comprising a permanent magnet 220 with a first north pole 240 and a first south pole 245; a second magnetic element 210, 211, 212, 213, 1210, 1212 comprising a permanent magnet 220 with a second north pole 241 and a second south pole 246; - mechanical connectors 250, 251, 252 extending between the first magnetic element 210 and the second magnetic element 211; The method is: - after implantation, elastically maintaining a first orientation 280 between the first magnetic element 210, 211, 212, 213, 1210, 1212 and the second magnetic element 210, 211, 212, 213, 1210, 1212 when arranged in human or animal tissue, wherein the magnetic markers 200, 201, 202, 203, 204, 205, 206, 207 are surrounded by an embedded marker volume with longitudinally embedded extents 200d, 201d, 202d, 203d, 204d, 205d, 206d and laterally embedded extents 200ef, 201ef, 202ef, 203ef, 204e, 205ef, 206e; - before or during implantation, assuming a second orientation 280 between the first magnetic element 210, 211, 212, 213, 1210, 1212 and the second magnetic element 210, 211, 212, 213, 1210, 1212, wherein the magnetic markers 200, 201, 202, 203, 204, 205, 206, 207 are surrounded by an implantation volume with a longitudinal implantation extent 400a and a lateral implantation extent 400b, whereby The laterally embedded areas 200ef, 201ef, 202ef, 203ef, 204e, 205ef, 206e are significantly larger than the laterally embedded areas 400b, and the longitudinally embedded areas 200d, 201d, 202d, 203d, 204d, 205d, 206d are significantly smaller than the longitudinal embedded areas 400a.

[0304] Optionally, the method comprises: - During implantation, the magnetic markers may further include moving through the implantation channel 400, wherein the implantation channel 400 has a lateral pore dimension 400b that is substantially equal to or greater than the lateral implantation extents 200b, 201b, 202b, 203b, 204b, 205b of the magnetic markers 200, 201, 202, 203, 204, 205, 206, 207.

[0305] Additionally or alternatively, the method may comprise: - During implantation, the magnetic markers may move through the implantation channel 400, the implantation channel 400 having a longitudinal hole dimension 400a that is substantially equal to or greater than the longitudinal implantation extents 200a, 201a, 202a, 203a, 204a, 205a of the magnetic markers 200, 201, 202, 203, 204, 205, 206, 207.

[0306] Additionally or alternatively, the method may comprise: During implantation, the magnetic markers may move through an implantation channel 400, the implantation channel 400 having pore dimensions 400a, 400b substantially equal to or greater than the implantation capacity of the magnetic markers 200, 201, 202, 203, 204, 205, 206, 207.

[0307] Additionally or alternatively, the method may comprise: - may include holding the north pole 240 of the first magnetic element 210, 211, 212, 213, 1210, 1212 and the north pole 241 or south pole 246 of the second magnetic element 210, 211, 212, 213, 1210, 1212 in close proximity, more proximal, very close proximity, in contact, or any combination thereof during and / or after implantation.

[0308] Additionally or alternatively, the method may comprise: - may include holding the south pole 245 of the first magnetic element 210, 211, 212, 213, 1210, 1212 and the north pole 241 or south pole 246 of the second magnetic element 210, 211, 212, 213, 1210, 1212 in close proximity, more proximal, very close proximity, in contact, or any combination thereof during and / or after implantation.

[0309] Additionally or alternatively, the method may comprise: During and / or after implantation, this may include folding the first magnetic elements 210, 212, 213, 1210, 1212 towards the second magnetic elements 211, 212 and / or folding the second magnetic elements 211, 212 towards the first magnetic elements 210, 212, 213, 1210, 1212, whereby the longitudinally embedded extents 200d, 201d, 202d, 203d, 204d, 205d, 206d are reduced compared to the longitudinal embedded extent 400a.

[0310] Additionally or alternatively, the method may comprise: During and / or after implantation, this may include folding the first magnetic elements 210, 212, 213, 1210, 1212 towards the second magnetic elements 211, 212 and / or folding the second magnetic elements 211, 212 towards the first magnetic elements 210, 212, 213, 1210, 1212, whereby the laterally embedded extents 200ef, 201ef, 202ef, 203ef, 204e, 205ef, 206e are increased compared to the laterally embedded extent 400b.

[0311] Additionally or alternatively, the implantable magnetic markers 203, 204, 207 may further include one or more mechanical anchors 260, 261, 262, and the method may further comprise: - It may further include that during and / or after implantation, the one or more mechanical anchors 260, 261, 262 can adopt a first shape and / or a first orientation relative to the magnetic markers 203, 204, 207, whereby changes in position of the one or more magnetic elements 210, 211, 212, 213, 1210, 1212 are largely resisted within human or animal tissue.

[0312] Additionally or alternatively, the method may comprise: - During implantation, one or more mechanical anchors 260, 261, 262 may adopt a second shape and / or a second orientation relative to the magnetic markers 203, 204, 207, thereby exerting a force against the inner surface of the implantation channel 400b to provide significant resistance to movement of the magnetic markers through the implantation channel 400.

[0313] Additionally or alternatively, the magnetic markers 201, 202, 205 may be: - a further magnetic element 212, 1212, 213 comprising a permanent magnet 220 with a further north pole and a further south pole; a further mechanical connector 251, 252 extending between the further magnetic element 212, 1212, 213 and the second magnetic element 211, 212, the further mechanical connector 251, 252 comprising: - further mechanical connectors 251, 252 configured and arranged to resiliently maintain a further first orientation between the further magnetic element 212, 1212, 213 and the second magnetic element 211, 212 when arranged in human or animal tissue, and to adopt a further second orientation between the further magnetic element 212, 1212, 213 and the second magnetic element 211 before and / or during implantation; The method is: - folding the first magnetic element 210, 1210, 213, 1212 towards the second magnetic element 211, 212 and / or folding the second magnetic element 211, 212 towards the first magnetic element 210, 1210, 213, 1212 during and / or after implantation; - during and / or after implantation, folding the further magnetic element 212, 1212, 213 towards the second magnetic element 211, 212 and / or folding the second magnetic element 211, 212 towards the further magnetic element 212, 1212, 213; Thereby, the longitudinal embedded areas 201d, 202d, 205d are reduced compared to the longitudinal embedded area 400a.

[0314] Additionally or alternatively, the laterally embedded extents 201ef, 202ef, 205ef may be increased compared to the laterally embedded extents 400b.

[0315] While the present invention has been described in connection with specific exemplary embodiments, it should be understood that various changes, substitutions, and alterations apparent to those skilled in the art can be made to the disclosed embodiments without departing from the spirit and scope of the invention, as set forth in the appended claims.

[0316] for example, one or more of the mechanical anchors 260, 261, 262A-I depicted in connection with Figures 8, 9 and 13 may be included in any magnetic marker described herein; - the polarity of any north and south poles of the magnetic elements may be reversed; - the magnetic marker may be configured and arranged to be embedded in either direction, with the first magnetic element emerging from the embedded channel at either end; - Magnetic markers comprising one or more mechanical anchors may be constructed and arranged for anchor-first and / or magnetic element-first implantation. [Explanation of symbols]

[0317] Reference numbers used in the drawings 100 Magnetic Field Marker Probe 110 one or more magnetic sensors 150 Probe longitudinal axis 160 Distal end of probe 200 First embodiment of implantable magnetic marker 200a Longitudinal extent of first embodiment 200b First lateral extent of the first embodiment 200d Longitudinal extent of the implanted first embodiment 200ef Lateral extent of the embedded first embodiment 200E-F Modified First Embodiment of Implantable Magnetic Marker 201 Second embodiment of implantable magnetic marker 201a Longitudinal extent of the second embodiment 201b First lateral extent of the second embodiment 201d Longitudinal extent of the embedded second embodiment 201ef Lateral extent of the embedded second embodiment 202 Third embodiment of implantable magnetic marker 202a Longitudinal extent of the third embodiment 202b First lateral extent of the third embodiment 202d Longitudinal extent of the implanted third embodiment 202ef Lateral extent of the embedded third embodiment 203 Fourth embodiment of implantable magnetic marker 203a Longitudinal extent of the fourth embodiment 203b First lateral extent of the fourth embodiment 203d Longitudinal extent of the implanted fourth embodiment 203ef Lateral extent of the embedded fourth embodiment 204 Fifth embodiment of implantable magnetic marker 204a Longitudinal extent of the fifth embodiment 204b First lateral extent of the fifth embodiment 204d Longitudinal extent of the implanted fifth embodiment 204e First lateral extent of the embedded fifth embodiment 205 Sixth embodiment of implantable magnetic marker 205a Longitudinal extent of the sixth embodiment 205b First lateral extent of the sixth embodiment 205d Longitudinal extent of the implanted sixth embodiment 205ef Lateral extent of the embedded sixth embodiment 206 Seventh embodiment of implantable magnetic marker 206d Longitudinal extent of implanted seventh embodiment 206e Lateral extent of embedded seventh embodiment 207A-I Further Embodiments of Implantable Magnetic Markers with One or More Mechanical Anchors 210 first magnetic element 1210 first magnetic element with reduced longitudinal extent 211 Second Magnetic Element 212 Further Magnetic Elements 1212 Further magnetic elements with reduced longitudinal extent 213 Additional Magnetic Elements 220 Permanent Magnet 220a Longitudinal extent of permanent magnet 220b first lateral extent of permanent magnet 230 cabinet 230a Longitudinal extent of the housing 230b first lateral extent of the housing 240 First North Pole 241 Second North Pole 245 First South Pole 246 Second South Pole 250 first mechanical connector 250E~F Modified First Mechanical Connector 251 Further Mechanical Connectors 252 Additional Further Mechanical Connectors 260 a first mechanical anchor configured as a first tissue anchor 261 a second mechanical anchor configured as a second tissue anchor 262A-I Further mechanical anchors configured as further tissue anchors 270 first central longitudinal plane for first magnetic element 1270 first central longitudinal plane for first magnetic element with reduced longitudinal extent 271 second central longitudinal plane for the second magnetic element 272 Further central longitudinal planes for further magnetic elements 1272 Further central longitudinal plane for further magnetic elements with reduced longitudinal extent 280 Orientation or Orientation Angle 300 outer surface of the skin 400 embedded channel, e.g. hollow needle 400a Longitudinal hole range 400b First transverse hole area

Claims

1. 1. An implantable magnetic marker for providing a detectable magnetic field, comprising: The markers (200, 201, 202, 203, 204, 205, 206, 207) are a first magnetic element (210, 211, 212, 213, 1210, 1212) comprising a first permanent magnet (220) with a north pole (240) and a south pole (245); a second magnetic element (210, 211, 212, 213, 1210, 1212) including a second permanent magnet (220) with a north pole (241) and a south pole (246); a rigid, flexible mechanical connector (250, 251, 252) extending between a rigid attachment to the first magnetic element and a rigid attachment to the second magnetic element, the mechanical connector (250, 251, 252) comprising: resiliently retaining a first orientation (280) between a first pole of the first permanent magnet and a first pole of the second permanent magnet when arranged in human or animal tissue, wherein the magnetic markers (200, 201, 202, 203, 204, 205, 206, 207) are surrounded by an embedded marker volume having longitudinally embedded extents (200d, 201d, 202d, 203d, 204d, 205d, 206d) and laterally embedded extents (200ef, 201ef, 202ef, 203ef, 204e, 205ef, 206e); and elastically retaining a second orientation (280) between the first pole of the first permanent magnet and the first pole of the second permanent magnet during implantation, wherein the mechanical connectors (250, 251, 252) are longitudinally disposed between the first pole of the first permanent magnet and the first pole of the second permanent magnet, and the magnetic markers (200, 201, 202, 203, 204, 205, 206, 207) are configured and disposed to elastically retain the magnetic markers (200, 201, 202, 203, 204, 205, 206, 207) surrounded by an implantation volume having a longitudinal implantation area (400a) and a lateral implantation area (400b), whereby rigid, flexible mechanical connectors (250, 251, 252) in which the laterally embedded areas (200ef, 201ef, 202ef, 203ef, 204e, 205ef, 206e) are significantly larger than the laterally embedded areas (400b) and the longitudinally embedded areas (200d, 201d, 202d, 203d, 204d, 205d, 206d) are significantly smaller than the longitudinally embedded areas (400a); An implantable magnetic marker, wherein the first pole of the first permanent magnet is the same pole as the first pole of the second permanent magnet, and the mechanical connectors (250, 251, 252) are configured and arranged to overcome a repulsive magnetic force between the first pole of the first permanent magnet and the first pole of the second permanent magnet.

2. The first and / or second magnetic element may comprise: The implantable magnetic marker of claim 1 , comprising a housing (230) with a cavity, the permanent magnet (220) being enclosed within the cavity.

3. The implantable magnetic marker of claim 2 , wherein the one or more housings (230) are constructed and arranged to substantially enclose the permanent magnet (220) within the cavity.

4. An implantable magnetic marker as described in any one of claims 2 or 3, wherein the one or more housings (230) are configured and arranged so that the arrangement of the north poles (240, 241) and / or south poles (245, 246) of the permanent magnets enclosed within the cavity can be changed relative to the one or more housings (230) during use.

5. The one or more housings (230) 5. The implantable magnetic marker of any one of claims 2 to 4, comprising a material selected from the group including titanium, stainless steel, surgical stainless steel, cobalt chromium, nickel titanium alloy (nitinol), platinum, tungsten, silver, gold, tantalum, iridium, or alloys thereof, or any combination thereof.

6. The one or more housings (230) An implantable magnetic marker as described in any one of claims 2 to 5, comprising one or more materials selected from the group including non-ferrous metals, titanium, aluminum, platinum, gold, silver, copper, glass, PTFE, plastic, weakly magnetic stainless steel, weakly magnetic martensitic stainless steel, weakly magnetic austenitic stainless steel, or any combination thereof.

7. An implantable magnetic marker as described in any one of claims 2 to 6, wherein the mechanical connectors (250, 251, 252) are firmly attached to the outer surface of the housing (230) contained in the first and / or second magnetic elements.

8. An implantable magnetic marker according to any one of claims 1 to 7, wherein the mechanical connectors (250, 251, 252) are firmly attached to the outer surface of the first and / or second permanent magnet.

9. The mechanical connectors (250, 251, 252) 9. The implantable magnetic marker of any one of claims 1 to 8, comprising one or more materials selected from the group including superelastic materials, pseudoelastic materials, shape memory materials, titanium, stainless steel, surgical stainless steel, cobalt chromium, nickel titanium alloy (nitinol), platinum, tungsten, silver, gold, tantalum, iridium, or alloys thereof, or any combination thereof.

10. An implantable magnetic marker as described in any one of claims 1 to 9, wherein the mechanical connector (250, 251, 252) extends between an end of the first magnetic element and an end of the second magnetic element having the same polarity.

11. The implantable magnetic marker of claim 10 , wherein the ends of the first and second magnetic elements having the same polarity are held at a predetermined and / or controlled closer position.

12. 12. An implantable magnetic marker as described in any one of claims 1 to 11, wherein the first magnetic elements are arranged along a first central longitudinal plane (270) and the second magnetic elements are arranged along a second central longitudinal plane (271), and the first and second orientations (280) are determined by first and second angles of intersection (280) between the first central longitudinal plane (270) and the second central longitudinal plane (271), respectively.

13. The implantable magnetic marker of claim 12, wherein the first intersection angle (280) is in the range of 0 degrees to 50 degrees.

14. 13. The implantable magnetic marker of claim 12, wherein the second intersection angle (280) is in the range of 160-200 degrees, and more preferably about 180 degrees.

15. An implantable magnetic marker as described in any one of claims 1 to 14, wherein the implantable magnetic marker (203, 204, 207) further comprises one or more mechanical anchors (260, 261, 262) configured and arranged to resist changes in position of one or more magnetic elements when arranged in human or animal tissue.

16. The one or more mechanical anchors (260, 261, 262) are 16. The implantable magnetic marker of claim 15, comprising one or more of a superelastic material, a pseudoelastic material, a shape memory material, titanium, stainless steel, surgical stainless steel, cobalt chromium, nickel titanium alloy (nitinol), platinum, tungsten, silver, gold, tantalum, iridium, or alloys thereof, or any combination thereof.

17. 17. An implantable magnetic marker as described in claim 15 or 16, wherein the one or more mechanical anchors (260, 261, 262) are configured and arranged to be substantially retracted before and / or during implantation and to extend laterally after implantation.

18. The embedded magnetic markers (201, 202, 205) are a third magnetic element (212, 1212, 213) including a third permanent magnet (220) with a north pole and a south pole; a second rigid flexible mechanical connector (251, 252) extending between the rigid attachment to the third magnetic element and the rigid attachment to the second magnetic element, said second mechanical connector (251, 252) comprising: resiliently maintaining a third orientation between a first pole of the third permanent magnet and a second pole of the second permanent magnet when arranged in human or animal tissue, wherein the magnetic marker is surrounded by the embedded marker volume having the longitudinally embedded extent and the transversely embedded extent; and second rigid, bendable mechanical connectors (251, 252) configured and arranged to elastically hold a fourth orientation between the first pole of the third permanent magnet and the second pole of the second permanent magnet during implantation, the second mechanical connectors (251, 252) being longitudinally disposed between the first pole of the third permanent magnet and the second pole of the second permanent magnet, the magnetic marker being surrounded by the implantation volume comprising the longitudinal implantation extent and the lateral implantation extent; An implantable magnetic marker as described in any one of claims 1 to 17, wherein the first pole of the third permanent magnet is the same pole as the second pole of the second permanent magnet, and the second mechanical connector (251, 252) is configured and arranged to overcome the repulsive magnetic force between the first pole of the third permanent magnet and the second pole of the second permanent magnet.

19. 20. The implantable magnetic marker of claim 18, wherein the first and third magnetic elements have longitudinal extents substantially less than the longitudinal extent of the second magnetic element.

20. The magnetic marker (205) An implantable magnetic marker as described in claim 18 or 19, wherein ends of the third magnetic element (1212) and the first magnetic element (1210) having opposite polarities are configured and arranged to be held at a predetermined and / or controlled closer position.

21. A kit for locating a tissue region of interest, comprising: One or more implantable markers (200, 201, 202, 203, 204, 205, 206, 207) according to any one of claims 1 to 20, comprising one or more permanent magnets (220); and a magnetic field marker probe (100) having one or more magnetic sensors (110) configured and arranged to measure the magnetic field generated by said one or more permanent magnets (220) after being placed in human or animal tissue.

22. A set of parts for embedding a magnetic marker, One or more implantable markers (200, 201, 202, 203, 204, 205, 206, 207) according to any one of claims 1 to 20, surrounded by one or more marker embedding volumes and comprising one or more permanent magnets (220); a recessed channel (400) having holes (400a, 400b) that are substantially equal to or greater than the recessed capacity of said one or more markers.

23. The kit of claim 22, wherein the buried channel (400) comprises one or more weakly magnetic materials.

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