Breast implantable marker and tissue marking device

Abstract

The invention discloses a mammary gland implantable marker and a tissue marking device, and relates to the technical field of medical apparatus and instruments, the implantable marker comprises a marking member which is provided with a through hole and is made of a metal material; the anchoring part is made of a flexible material capable of absorbing liquid and expanding, the anchoring part is arranged in the through hole in a penetrating mode, at least one end of the anchoring part extends out of the through hole, the anchoring part is attached to the through hole in a self-adaptive mode in the dehydration state, and the anchoring part is in interference fit or close fit with the through hole through liquid absorption and expansion. According to the technical scheme provided by the invention, the displacement risk after the implantable marker is implanted into the tissue is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a breast implantable marker and tissue marker device. Background Technology

[0002] In medical settings such as tumor treatment and tissue biopsy follow-up, implantable markers are widely used for precise localization of target tissues. These markers are typically implanted proximal to the target lesion using imaging-guided implantation tools, leaving them embedded within the tissue lesion to provide localization references for subsequent surgical localization and imaging follow-up.

[0003] Currently, the most commonly used implantable markers for breast tissue in clinical practice are made of metal materials (such as titanium alloys and stainless steel) to meet the requirements for clear imaging in imaging examinations.

[0004] However, existing breast implantable markers are prone to displacement after implantation due to factors such as biological activity and tissue peristalsis, leading to inaccurate lesion localization. Summary of the Invention

[0005] The main objective of this invention is to provide a breast implantable marker and tissue marker device, which aims to reduce the risk of displacement of the implantable marker after implantation into the tissue.

[0006] To achieve the above objectives, the present invention proposes an implantable marker comprising: A marker element, having a through hole, wherein the marker element is made of metal; and An anchor, wherein the anchor is made of a flexible material that absorbs liquid and expands, the anchor is inserted through the through hole and at least one end extends outside the through hole, and the anchor adaptively adheres to the through hole in the dehydrated state, and the anchor is interference-fitted or tightly fitted with the through hole by absorbing liquid and expanding.

[0007] In one embodiment, the marker has ends corresponding to both ends of the through hole, and the anchor includes: The main body segment passes through the through hole; and The anti-detachment section is provided at both ends of the main body section. The anti-detachment section expands by absorbing liquid and blocks the corresponding ends of the marker to prevent the marker and the anchor from moving relative to the axis of the through hole.

[0008] In one embodiment, regardless of whether it is in a dehydration state or a liquid absorption and swelling state, the outer peripheral dimension of the anti-detachment section is larger than the outer peripheral dimension of the main body section; and / or, The main body and the anti-detachment section are an integral structure.

[0009] In one embodiment, the marker includes a marker body and a partition connected to the marker body, the through hole is formed on the marker body, the partition is disposed at one end of the through hole and forms an exposed gap space between the partition and the through hole, and the partition has a pushing surface facing away from the gap space; One of the anti-detachment sections is the first anti-detachment section. The anchor extends out of the through hole to the side where the partition is located to form the first anti-detachment section. The partition separates the first anti-detachment section from the pushing surface.

[0010] In one embodiment, the marker further includes a connecting portion that connects the partition portion and the marker body.

[0011] In one embodiment, the connecting portion is a linear connecting portion extending along the axial direction of the through hole, one end of the linear connecting portion is connected to one end of the marking body, and the other end of the linear connecting portion is connected to the partition portion.

[0012] In one embodiment, the length of the first anti-detachment section is greater than the distance of the interval space along the axial direction of the through hole. When the anchor is in a liquid-absorbing and expanding state, the first anti-detachment section is squeezed into the interval space and partially fits against the partition.

[0013] In one embodiment, the anchor is made of an elastic material, and the anti-detachment section can be bent relative to the main body section under external force.

[0014] In one embodiment, the marker includes a marker body, which is a coil formed by spirally arranging a metal wire around a predetermined axis, the metal wire surrounding the through hole; when the anchor absorbs liquid and expands, the anchor tightly fills the gap between adjacent turns of the marker body, thereby achieving locking with the coil.

[0015] In one embodiment, the marking element is made of titanium, titanium alloy, platinum-tungsten alloy, or stainless steel; and / or, The anchor is made of polyvinyl alcohol sponge.

[0016] The present invention also proposes a tissue marking device, comprising: The aforementioned breast implantable markers; and A marker implantation tool for transferring the breast implantable marker into the target tissue.

[0017] The present invention also proposes a tissue marking device, comprising: The aforementioned breast implantable markers; and The marker implantation tool has a marker storage space, at least one of the anti-detachment segments is bent relative to the main body segment and adaptively abuts against the inner wall of the marker storage space. The marker implantation tool is used to temporarily store the breast implantable marker and transfer the breast implantable marker from the marker storage space to the target tissue.

[0018] The breast implantable marker of this invention includes a marker and an anchor. The anchor is inserted into a through-hole in the marker, with at least one end extending outside the through-hole. The marker is made of metal, allowing it to be clearly visualized in imaging examinations, meeting the needs of surgical positioning and follow-up observation. The anchor is made of a flexible material that absorbs and expands with liquid. In its dehydrated state, the anchor conforms adaptively to the through-hole, making it easier to insert and facilitating assembly. After implantation into breast tissue, the anchor absorbs surrounding tissue fluid and expands. On one hand, this allows the portion of the anchor inside the through-hole to form an interference fit or a tight fit with the through-hole, thus ensuring a tight connection between the anchor and the marker and reducing the risk of separation. On the other hand, the portion of the anchor extending outside the through-hole, after absorbing fluid and expanding, compresses against the surrounding tissue, enhancing the anchoring force of the breast implant marker within the tissue. This effectively reduces the possibility of displacement due to biological activity, tissue peristalsis, and other factors, and also helps prevent the anchor from detaching from the through-hole, further reducing the risk of separation. Furthermore, using a flexible anchor for anchoring within the tissue helps reduce scratches and compression irritation to the breast tissue, improving implantation safety and reducing patient discomfort. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0020] Figure 1 A schematic diagram of the structure of an embodiment of the breast implantable marker provided by the present invention. Figure 1 ; Figure 2 A schematic diagram of the structure of an embodiment of the breast implantable marker provided by the present invention. Figure 2 ; Figure 3 A schematic diagram of the structure of the anchor of the breast implantable marker provided by the present invention; Figure 4 Schematic diagram of the structure of the marker element for the breast implantable marker provided by the present invention Figure 1; Figure 5 Schematic diagram of the structure of the marker element for the breast implantable marker provided by the present invention Figure 2 ; Figure 6 A schematic diagram of the structure of an embodiment of the breast implantable marker provided by the present invention. Figure 3 ; Figure 7 A partial view of the location where a breast tissue marker is placed in the tissue marking device.

[0021] Explanation of icon numbers: 100. Marking element; 101. Through hole; 102. Spacing space; 110. Marking body; 120. Connecting part; 130. Partition; 131. Pushing surface; 200. Anchor; 210. Main body section; 220. Anti-detachment section; 221. First anti-detachment section; 2211. First sub-section; 2212. Second sub-section; 2213. Third sub-section; 222. Second anti-detachment section; 2221. Fourth sub-section; 2222. Fifth sub-section; 300. Marker implantation tool; 310. Needle; 311. Marker temporary storage space; 320. Push needle.

[0022] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0024] It should be noted that if the embodiments of the present invention involve directional indicators (such as up, down, left, right, front, back, etc.), the directional indicators are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indicators will also change accordingly.

[0025] In this invention, unless otherwise explicitly specified and limited, the terms "connection" and "fixed" should be interpreted broadly. For example, "fixed" can mean a fixed connection, a detachable connection, or an integral part; "connection" can mean a mechanical connection or an electrical connection, a direct connection or an indirect connection through an intermediate medium, or a connection within two components or an interaction between two components. Unless otherwise explicitly limited, those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0026] Furthermore, if the embodiments of this invention involve descriptions such as "first" or "second," these descriptions are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the meaning of "and / or" throughout the text includes three parallel solutions. Taking "A and / or B" as an example, it includes solution A, solution B, or a solution that simultaneously satisfies A and B. Furthermore, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0027] This invention proposes a breast implantable marker.

[0028] Please see Figure 1 and Figure 4 , Figure 1 A schematic diagram of the structure of an embodiment of the breast implantable marker provided by the present invention. Figure 1 , Figure 4 This is a schematic diagram of the structure of the marker component of the breast implantable marker provided by the present invention.

[0029] In one embodiment of the present invention, the breast implantable marker includes: The marker 100 has a through hole 101 and is made of metal; and Anchor 200 is made of a flexible material that absorbs liquid and expands. Anchor 200 is inserted through the through hole 101 and at least one end extends outside the through hole 101. Anchor 200 adaptively adheres to the through hole 101 in the dehydrated state. Anchor 200 is interference-fitted or tightly fitted with the through hole 101 by absorbing liquid and expanding.

[0030] The breast implantable marker in this invention includes a marker 100 and an anchor 200. The anchor 200 is inserted into a through-hole 101 of the marker 100, with at least one end extending outside the through-hole 101. The marker 100 is made of metal, allowing it to be clearly visualized in imaging examinations, meeting the needs of surgical positioning and follow-up observation. The anchor 200 is made of a flexible material that absorbs and expands with liquid. In a dehydrated state, the anchor 200 adaptively conforms to the through-hole 101, making it easier to insert into the through-hole 101 and facilitating assembly. After implantation into breast tissue, the anchor 200 absorbs surrounding tissue fluid and expands. On one hand, this allows the portion of the anchor 200 located within the through-hole 101 to form an interference fit or a tight fit with the through-hole 101, thus ensuring a tight connection between the anchor 200 and the marker 100 and reducing the risk of separation. On the other hand, the portion of the anchor 200 extending outside the through-hole 101, after absorbing fluid and expanding, will compress against the surrounding tissue, enhancing the anchoring force of the breast implant marker within the tissue. This effectively reduces the possibility of displacement of the breast implant marker due to biological activity, tissue peristalsis, etc., and also helps to prevent the anchor 200 from detaching from the through-hole 101, further reducing the risk of separation between the anchor 200 and the marker 100. Furthermore, using the flexible anchor 200 for anchoring within the tissue helps to reduce scratches and compression irritation to the breast tissue, improving implantation safety and reducing patient discomfort.

[0031] In one embodiment, the marker 100 has ends corresponding to both ends of the through hole 101, and the anchor 200 includes: Main body section 210, passing through through hole 101; and Anti-detachment section 220: Both ends of the main body section 210 are provided with anti-detachment section 220. The anti-detachment section 220 expands by absorbing liquid and blocks the corresponding ends of the marker 100 to prevent the marker 100 and the anchor 200 from moving in the axial direction relative to the through hole 101.

[0032] Combination Figures 1 to 3In an embodiment of the present invention, the anchor 200 includes a main body segment 210 and an anti-detachment segment 220. The main body segment 210 passes through the through hole 101 of the marker 100, and both ends of the main body segment 210 extend outside the through hole 101. The anti-detachment segment 220 is disposed at both ends of the main body segment 210. After absorbing liquid and swelling, its volume increases, thereby preventing the main body segment 210 from moving axially along the through hole 101, and thus preventing the main body segment 210 from detaching from the through hole 101. By providing the anti-detachment segment 220 at the end of the main body segment 210 extending outside the through hole 101, the volume of the portion of the anchor 200 located outside the through hole 101 after absorbing liquid and swelling is further increased, thereby further enhancing the anchoring force of the breast implantable marker in the tissue and further reducing the risk of separation between the anchor 200 and the marker 100.

[0033] In one embodiment, the outer periphery of the anti-detachment section 220 is larger than that of the main body section 210, regardless of whether it is in a dehydrated state or a liquid-absorbing and swelling state. It is worth noting that the outer periphery of either the marker 100 or the anchor 200 on the interface perpendicular to its own axis can be circular, but it can also be rectangular or any other shape with an outer periphery.

[0034] In embodiments of the present invention, the outer circumferential dimensions of the anti-detachment section 220 are all larger than the outer circumferential dimensions of the main body section 210. For example, when the cross-sections of both the main body section 210 and the anti-detachment section 220 are circular, the outer diameter of the anti-detachment section 220 can be larger than the outer diameter of the main body section 210; when the cross-sections of both the main body section 210 and the anti-detachment section 220 are rectangular, the thickness of the anti-detachment section 220 can be greater than the thickness of the main body section 210, or the width of the anti-detachment section 220 can be greater than the width of the main body section 210. The axial limiting is directly formed by the dimensional difference between the anti-detachment section 220 and the main body section 210, reducing the risk of separation between the anchor 200 and the marker 100. The structure is simple and easy to manufacture.

[0035] In one embodiment, the main body section 210 and the anti-detachment section 220 are an integral structure.

[0036] In the embodiments of the present invention, the main body section 210 and the anti-detachment section 220 are integrally formed from the same liquid-absorbing and swelling material, which ensures the connection firmness of each part of the anchor 200, thereby ensuring the service life of the anchor 200; on the other hand, it is easy to process and manufacture, which is conducive to improving production efficiency.

[0037] In one embodiment, the marker 100 includes a marker body 110 and a partition 130 connected to the marker body 110. A through hole 101 is formed on the marker body 110. The partition 130 is disposed at one end of the through hole 101 and forms an exposed space 102 between the through hole 101 and the through hole 101. The partition 130 has a pushing surface 131 facing away from the space 102. One of the anti-detachment sections 220 is the first anti-detachment section 221. The anchor 200 extends through the through hole 101 to the side where the partition 130 is located to form the first anti-detachment section 221. The partition 130 is used to separate the first anti-detachment section 221 from the pushing surface 131.

[0038] Reference Figure 1 , Figure 2 and Figure 4 In an embodiment of the present invention, the marker 100 includes a marker body 110 and a partition 130. The partition 130 is located at one end of the through hole 101, and a space 102 is formed between the partition 130 and the through hole 101. An anti-dislodgement section 220 (i.e., a first anti-dislodgement section 221) is disposed in this space 102, and the partition 130 has a pushing surface 131 facing away from the space 102. The pushing surface 131 is the force-bearing surface during the implantation operation. Specifically, refer to... Figure 7 Before implantation, the breast implantable marker is placed in the needle 310 of the marker implantation tool 300. After the needle 310 is inserted into the target tissue, the breast implantable marker is pushed by the pusher needle 320 inside the needle 310, thereby pushing the breast implantable marker from the needle 310 into the target tissue to complete the implantation operation. When the breast implantable marker is inside the needle 310, the pushing surface 131 of the partition 130 faces the pusher needle 320, and the pusher needle 320 abuts against it. The push surface 131 pushes the partition 130, thereby driving the entire breast implant marker to move. Since the marker 100 is made of metal and is relatively hard, while the anchor 200 is made of a flexible material that absorbs liquid and expands, the push needle 320 pushing the partition 130 can prevent the push needle 320 from contacting or inserting into the flexible anchor 200. This ensures the efficiency of pushing the breast implant marker out of the needle tube 310 and also prevents the push needle 320 from damaging the anchor 200.

[0039] Specifically, a partition 130 can be provided at one end of the marker body 110 to reduce the overall length of the marker 100 and the weight of the breast implantable marker, thereby reducing discomfort after implantation. Alternatively, partitions 130 can be provided at both ends of the marker body 110 to further reduce the risk of separation between the anchor 200 and the marker 100. Furthermore, when the breast implantable marker is inserted into the needle 310 of the marker implantation tool 300, it is not necessary to distinguish which end of the breast implantable marker faces the push needle 320, thus improving the convenience of assembling the breast implantable marker with the marker implantation tool 300.

[0040] In one embodiment, the marker 100 further includes a connecting portion 120, which connects the partition portion 130 and the marker body 110.

[0041] Reference Figure 4In an embodiment of the present invention, the marker body 110 and the partition 130 are connected by a connecting part 120 to ensure that the partition 130 will not move away from the marker body 110 or even separate from the marker body 110 due to the expansion of the anchor 200 or tissue peristalsis, thus ensuring the integrity of the entire marker 100 and improving the reliability of the breast implantable marker.

[0042] In one embodiment, the connecting portion 120 is a linear connecting portion extending along the axial direction of the through hole 101. One end of the linear connecting portion is connected to one end of the marking body 110, and the other end of the linear connecting portion is connected to the partition portion 130.

[0043] Reference Figure 4 In embodiments of the present invention, the connecting portion 120 is a linear connecting portion, that is, the connecting portion 120 has a linear structure in the form of a straight line or strip, which reduces the obstruction of the first anti-detachment section 221 in the space 102 during the expansion of the first anti-detachment section 221 when it absorbs liquid. Except for the area near the linear connecting portion where the expansion is hindered, the first anti-detachment section 221 can maintain the expansion effect in the radial direction, which is beneficial to ensure the anchoring effect and the imaging effect. The length direction of the linear connecting portion extends along the axial direction of the through hole 101, which is beneficial to reduce the interference of the anchor 200 passing through the through hole 101, improve the convenience of assembling the anchor 200 and the marker 100, and has a simple structure and light weight, which reduces the manufacturing difficulty and also reduces the discomfort caused to the patient by the marker in the breast tissue.

[0044] In one embodiment, the length of the first anti-detachment section 221 is greater than the distance of the space 102 along the axial direction of the through hole 101. When the anchor 200 is in a liquid-absorbing and expanding state, the first anti-detachment section 221 is squeezed into the space 102 and partially fits against the partition 130.

[0045] In an embodiment of the present invention, the shape of the anchor 200 and the marker 100 after assembly is as follows: Figure 6 As shown, the length of the first anti-detachment section 221 is longer than the distance of the space 102 along the axial direction of the through hole 101, that is, the length of the first anti-detachment section 221 is longer than the distance between the partition 130 and the marking body 110. Figure 2 The first anti-detachment section 221 can be squeezed into the spacer 102 using its flexibility. Upon absorbing liquid and expanding, it further strengthens the compressive force between the first anti-detachment section 221 and the end of the marker body 110, the connecting portion 120, and the partition portion 130, enhancing the static friction between the anchor 200 and the marker 100 and further reducing the risk of relative movement or separation between the anchor 200 and the marker 100. Furthermore, after absorbing liquid and expanding, the first anti-detachment section 221 defines a portion of the boundary through the connecting portion 120 and the partition portion 130, which helps to form a clearer image boundary, thus facilitating identification during image examination.

[0046] In one embodiment, the anchor 200 is made of an elastic material, and the anti-detachment section 220 can be bent relative to the main body section 210 under the action of external force.

[0047] Reference Figure 1 , Figure 2 and Figure 6 In embodiments of the present invention, the anti-detachment segment 220 can be bent relative to the main body segment 210 under external force, so that the anti-detachment segment 220 is at different angles and shapes relative to the main body segment 210, further enhancing the anchoring force of the anchor 200 in the tissue, reducing the possibility of displacement of the breast implant marker due to biological activity, tissue peristalsis and other factors, and also helping to prevent the anchor 200 from falling out of the through hole 101, further reducing the risk of separation between the anchor 200 and the marker 100. On the other hand, when assembling the marker 100 and the anchor 200, based on the elasticity and flexibility of the anchor 200 itself, it is convenient to sleeve the coil part of the marker 100 onto the main body segment 210, improving the convenience of assembling the marker 100 and the anchor 200.

[0048] Specifically, the shape of the anchor 200 and the marker 100 after assembly is as follows: Figure 6 As shown, when the breast implantable marker is inserted into the needle tube 310, the anti-dislodgement section 220 of the anchor 200 is bent, for example, to form a shape like... Figure 2 , Figure 3 The shape shown allows the anti-detachment section 220 to adaptively conform to the inner wall of the marker storage space 311, as... Figure 7 As shown, this reduces the likelihood of the marker sliding within the marker storage space 311.

[0049] It is worth mentioning that, under dehydration conditions, the first anti-hair loss stage 221 is not in a state of... Figure 2 Instead of being in a state where it is in contact with the partition 130, the first anti-detachment section 221 is bent relative to the main body section 210, and the first anti-detachment section 221 abuts against the end of the partition 130 after bending; only after absorbing liquid and expanding will the first anti-detachment section 221 open up like... Figure 2 The portion shown is attached to the partition 130, but the outer contour of the first anti-slip section 221 is larger than that shown. Figure 2 The one shown in the middle is larger and is blocked at the end corresponding to the main body 110 of the mark.

[0050] by Figure 2 , Figure 3Taking the bending shape shown as an example, in the state of liquid absorption and expansion after entering the tissue, the first anti-detachment section 221 of the bending expands through liquid absorption to form a first sub-segment 2211 and a second sub-segment 2212. The first sub-segment 2211 extends along the axial direction of the through hole 101, extending from the periphery of the through hole 101 to the partition portion 130. The second sub-segment 2212 bends relative to the first sub-segment 2211 and fits against the partition portion 130.

[0051] by Figure 2 , Figure 3 Taking the bending shape shown as an example, the first anti-detachment segment 221, after absorbing liquid and swelling, forms a third segment 2213. One end of the third segment 2213 connects to the second segment 2212, and the other end extends away from the first segment 2211. This results in the first segment 2211, the second segment 2212, and the third segment 2213 forming a multi-level bending structure outside the through hole 101, further improving the anti-detachment capability of the anchor 200 and the marker 100. Furthermore, after absorbing liquid and swelling, the first segment 2211, the second segment 2212, and the third segment 2213 anchor to the surrounding tissue in multiple directions, thereby increasing the contact area and anchoring force with the tissue and further reducing the risk of displacement of the entire breast implant marker due to biological activity or tissue peristalsis. It is worth mentioning that the outer contours of the first segment 2211, the second segment 2212, and the third segment 2213 after absorbing liquid and swelling are larger than... Figure 2 The image displayed is larger.

[0052] In the dehydrated state, the anti-detachment section 220, located away from the partition 130, is the second anti-detachment section 222. When the breast implantable marker is inserted into the needle tube 310, the second anti-detachment section 222 is bent. Figure 2 , Figure 3 Taking the bending shape shown as an example, the fourth segment 2221 and the fifth segment 2222 are formed by bending. The fourth segment 2221 is connected to the main segment 210 and bent relative to the main segment 210. The fifth segment 2222 is connected to the fourth segment 2221 and bent relative to the fourth segment 2221. This makes the fourth segment 2221 and the fifth segment 2222 form a multi-level bending structure located outside the through hole 101, further improving the anti-detachment ability of the anchor 200 and the marker 100. Furthermore, after absorbing liquid and swelling, the fourth segment 2221 and the fifth segment 2222 anchor to the surrounding tissue in multiple directions, thereby increasing the contact area and anchoring force with the tissue, further reducing the risk of displacement of the entire breast implant marker. It is worth mentioning that the outer contour of the fourth segment 2221 and the fifth segment 2222 after absorbing liquid and swelling will be larger than that of the fifth segment 2221. Figure 2 The image displayed is larger.

[0053] by Figure 2 , Figure 3Taking the bending configuration shown as an example, the main body segment 210 and the fifth sub-segment 2222 clamp the inner and outer sides of the marking body 110 of the marking element 100, so that the main body segment 210, the fourth sub-segment 2221, and the fifth sub-segment 2222 form a circumferential restraint on the marking element 100. This restricts both the axial displacement of the marking element 100 relative to the anchor 200 and the radial displacement of the marking element 100 relative to the anchor 200, further reducing the risk of separation between the marking element 100 and the anchor 200. Furthermore, after the anchor 200 absorbs liquid, the main body segment 210, the fourth sub-segment 2221, and the fifth sub-segment 2222 all expand, causing the main body segment 210 and the fifth sub-segment 2222 to clamp and squeeze the marking element 100 from both sides, further reducing the risk of separation between the anchor 200 and the marking element 100.

[0054] Reference Figure 2 and Figure 3 Specifically, in this embodiment, the two ends of the main body segment 210 are respectively provided with a first anti-detachment segment 221 and a second anti-detachment segment 222. When the breast implantable marker is inserted into the needle tube 310, the first anti-detachment segment 221 and the second anti-detachment segment 222 are bent into different shapes. After the two different anti-detachment segments 220 absorb water and expand, they will form different anchoring structures with the surrounding tissue, so that the entire breast implantable marker is further anchored with the surrounding tissue in multiple directions, further reducing the risk of the breast implantable marker shifting in the tissue.

[0055] In one embodiment, the marker 100 includes a marker body 110, which is a coil formed by spirally arranging a metal wire around a predetermined axis, with the metal wire surrounding and forming a through hole 101; when the anchor 200 absorbs liquid and expands, the anchor 200 tightly fills the gap between adjacent turns of the marker body 110, thereby achieving locking with the coil.

[0056] Combination Figure 1 and Figure 4In an embodiment of the present invention, the marker 100 includes a marker body 110, which is a coil formed by a metal wire spirally arranged around a predetermined axis. The spirally arranged metal wire surrounds a through hole 101 through which the anchor 200 passes. The shape of the coil ensures that the marker 100 is lightweight, reducing the pressure and irritation of the breast implantable marker on surrounding tissues and alleviating patient discomfort after implantation. At the same time, it increases the volume of the marker 100, ensuring that the marker 100 can form a clearer and more conspicuous imaging outline in imaging examinations, thereby facilitating users to more accurately locate lesions and improve the accuracy of lesion marking. On the other hand, the spirally wound coil is similar to a spring and has a certain degree of elasticity. When the anchor 200 absorbs liquid and expands, it can cause the coil to deform slightly. At the same time, the coil will generate a reverse contraction elastic force, thereby making the anchor 200 and the marker 100 fit more tightly, enhancing the firmness of the connection between the two, and further reducing the risk of separation. On the other hand, the anchor 200, after absorbing liquid and expanding, will fill the gap between each adjacent turn of metal wire in the coil, thereby locking the anchor 200 with the coil and further making the anchor 200 and the marker 100 tightly connected, reducing the risk of separation.

[0057] In one embodiment, the coil, the connecting part 120, and the partition part 130 are an integral structure.

[0058] In the embodiments of the present invention, the marking body 110 (i.e., coil), the connecting part 120 and the partition part 130 are integrally formed from the same metal wire, which ensures the strong connection of each part of the marking component 100, thereby ensuring the service life of the marking component 100; on the other hand, it is easy to process and manufacture, which is conducive to improving production efficiency.

[0059] In one embodiment, the marker 100 is made of titanium, titanium alloy, platinum-tungsten alloy, or stainless steel; and / or, Anchor 200 is made of polyvinyl alcohol sponge.

[0060] In embodiments of the present invention, the marker 100 can be made of platinum-tungsten alloy. Platinum-tungsten alloy has excellent radiopaqueness, resulting in high imaging clarity during imaging examinations. It also meets the biocompatibility requirements for implantable medical devices, and after implantation, it will not cause significant inflammatory reactions or tissue rejection, allowing it to remain safely at the lesion site for a long period. The marker 100 can also be made of stainless steel, such as high-nitrogen nickel-free stainless steel. Stainless steel has good mechanical strength and corrosion resistance, and also meets the biocompatibility requirements for implantable medical devices. After implantation, it will not cause significant inflammatory reactions or tissue rejection, allowing it to remain safely at the lesion site for a long period. The marker 100 can also be made of titanium or titanium alloy. Both titanium and titanium alloy have good biocompatibility, and after implantation, they will not cause significant inflammatory reactions or tissue rejection, allowing them to remain safely at the lesion site for a long period.

[0061] In an embodiment of the present invention, the anchor 200 is made of polyvinyl alcohol sponge. Polyvinyl alcohol sponge has excellent liquid absorption and expansion properties. After contact with human tissue fluid, it will quickly absorb the liquid and expand in volume. The expansion rate is controllable and the shape is stable. In addition, polyvinyl alcohol sponge has good biocompatibility. After implantation into the human body, it will not cause obvious immune rejection. After implantation into the human body, it will not cause obvious inflammatory response or tissue rejection. It can be safely retained in the lesion site for a long time.

[0062] The present invention also proposes a tissue marking device, comprising: The aforementioned breast implantable markers; and Marker implantation tool 300 is used to transfer implantable breast markers into target tissue.

[0063] The specific structure of the implantable marker is as described in the above embodiments. Since this tissue marking device adopts all the technical solutions of all the above embodiments, it has at least all the beneficial effects brought about by the technical solutions of the above embodiments, which will not be repeated here.

[0064] In one embodiment, the marker implantation tool 300 is provided with a marker storage space 311, at least one anti-detachment segment 220 is bent relative to the main body segment 210 and adaptively abuts against the inner wall of the marker storage space 311. The marker implantation tool 300 is used to temporarily store breast implantable markers and transfer breast implantable markers from the marker storage space 311 to the target tissue.

[0065] Reference Figure 7 In embodiments of the present invention, both the breast implantable marker and the marker implantation tool 300 are single-use devices. Before leaving the factory, the breast implantable marker is placed in the marker storage space 311 of the marker implantation tool 300, reducing the risk of contamination by bacteria and other substances when the breast implantable marker is exposed to the external environment before implantation, thus improving the safety of the breast implantable marker. Furthermore, when the breast implantable marker is placed inside the marker storage space 311, the anti-detachment section 220 of the anchor 200 adaptively abuts against the inner wall of the marker storage space 311, reducing the possibility of the marker sliding within the marker storage space 311, thereby reducing the possibility of it falling out of the marker storage space 311 during transportation and improving user convenience.

[0066] The above description is merely an exemplary embodiment of the present invention and does not limit the scope of protection of the present invention. Any equivalent structural transformations made based on the technical concept of the present invention and the contents of the specification and drawings of the present invention, or direct / indirect applications in other related technical fields, are included within the scope of protection of the present invention.

Claims

1. A breast implantable marker, characterized in that, include: A marker element with a through hole, the marker element being made of metal; as well as An anchor, wherein the anchor is made of a flexible material that absorbs liquid and expands, the anchor is inserted through the through hole and at least one end extends outside the through hole, and the anchor adaptively adheres to the through hole in the dehydrated state, and the anchor is interference-fitted or tightly fitted with the through hole by absorbing liquid and expanding.

2. The breast implantable marker as described in claim 1, characterized in that, The marker has ends corresponding to both ends of the through hole, and the anchor includes: The main body segment passes through the through hole; and The anti-detachment section is provided at both ends of the main body section. The anti-detachment section expands by absorbing liquid and blocks the corresponding ends of the marker to prevent the marker and the anchor from moving relative to the axis of the through hole.

3. The breast implantable marker as described in claim 2, characterized in that, Whether in the dehydration state or the liquid absorption and swelling state, the outer peripheral dimension of the anti-detachment section is larger than the outer peripheral dimension of the main body section; and / or, The main body and the anti-detachment section are an integral structure.

4. The breast implantable marker as described in claim 2, characterized in that, The marking element includes a marking body and a partition connected to the marking body. The through hole is formed on the marking body. The partition is disposed at one end of the through hole and forms an exposed gap space with the through hole. The partition has a pushing surface facing away from the gap space. One of the anti-detachment sections is the first anti-detachment section. The anchor extends out of the through hole to the side where the partition is located to form the first anti-detachment section. The partition separates the first anti-detachment section from the pushing surface.

5. The breast implantable marker as described in claim 4, characterized in that, The marker also includes a connecting portion that connects the partition portion and the marker body.

6. The breast implantable marker as described in claim 5, characterized in that, The connecting part is a linear connecting part extending along the axial direction of the through hole. One end of the linear connecting part is connected to one end of the marking body, and the other end of the linear connecting part is connected to the partition part.

7. The breast implantable marker as described in claim 4, characterized in that, The length of the first anti-detachment section is greater than the distance of the interval space along the axis of the through hole. When the anchor is in a liquid-absorbing and expanding state, the first anti-detachment section is squeezed into the interval space and partially fits against the partition.

8. The breast implantable marker as described in any one of claims 2-7, characterized in that, The anchor is made of an elastic material, and the anti-detachment section can be bent relative to the main body section under external force.

9. The breast implantable marker as described in claim 1, characterized in that, The marking element includes a marking body, which is a coil formed by spirally arranging a metal wire around a predetermined axis, and the metal wire surrounds and forms the through hole; when the anchor absorbs liquid and expands, the anchor tightly fills the gap between adjacent turns of the marking body, thereby achieving locking with the coil.

10. The breast implantable marker as described in claim 1, characterized in that, The marking element is made of titanium, titanium alloy, platinum-tungsten alloy, or stainless steel; and / or, The anchor is made of polyvinyl alcohol sponge.

11. A tissue marking device, characterized in that, include: Breast implantable markers as described in any one of claims 1 to 10; as well as A marker implantation tool for transferring the breast implantable marker into the target tissue.

12. A tissue marking device, characterized in that, include: The breast implantable marker as described in claim 8; as well as The marker implantation tool has a marker storage space, at least one of the anti-detachment segments is bent relative to the main body segment and adaptively abuts against the inner wall of the marker storage space. The marker implantation tool is used to temporarily store the breast implantable marker and transfer the breast implantable marker from the marker storage space to the target tissue.

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