Degradable anti-migration fluorescent visualization breast localization needle
By designing a biodegradable, non-displacement fluorescent breast positioning needle, utilizing polylactic acid material and a spiral barb structure, combined with fluorescent imaging, the problem of easy displacement of breast positioning needles has been solved, achieving clear positioning and improved safety during breast surgery.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- THE FIRST AFFILIATED HOSPITAL OF NAVAL MEDICAL UNIVERSITY OF CHINESE PEOPLES LIBERATION ARMY
- Filing Date
- 2025-04-21
- Publication Date
- 2026-07-03
AI Technical Summary
Existing breast localization needles are prone to displacement when the patient's position changes or tissue is stretched. They cannot effectively resist multi-directional displacement forces, especially in deep small lesions, where they are prone to displacement and require a second surgery to remove, increasing patient pain and infection risk.
A biodegradable, anti-displacement fluorescent mammography positioning needle is designed. The needle and barbs are integrally molded using polylactic acid material. The barbs are arranged in alternating spirals and coated with barium sulfate. Combined with fluorescent marker balls for imaging, the fixation patch is made of polyurethane film that adheres to the skin, providing multi-directional anchoring and clear imaging.
Clear visualization under X-ray and ultrasound prevents needle displacement, avoids secondary surgery, reduces the risk of infection, enhances fixation, adapts to skin undulations, and reduces the amount of normal tissue removed.
Smart Images
Figure CN224441362U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and in particular to a biodegradable, anti-displacement fluorescent imaging breast positioning needle. Background Technology
[0002] This is a preoperative procedure performed under mammography (X-ray or ultrasound) to locate occult breast lesions, making breast-conserving surgery safer, faster, and with less incision trauma. First, the radiologist and his assistant use a breast positioning needle to insert a guide wire at the breast lesion site before the breast surgery to locate its location and extent. Then, the surgeon accurately locates the lesion according to the guide wire, thus achieving a small incision and greatly reducing the amount of normal tissue removed.
[0003] However, existing technologies often rely on single barbs or a small number of hook structures (such as a four-hook design) when using breast localization needles. These are prone to displacement when the body position changes or tissue is pulled. The barbs only provide unidirectional fixation and cannot resist multidirectional displacement forces, especially causing small deep lesions to easily shift.
[0004] Therefore, this invention provides a biodegradable, anti-displacement fluorescent mammography positioning needle. Utility Model Content
[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a biodegradable, anti-displacement fluorescent breast localization needle.
[0006] To achieve the above objectives, this utility model adopts the following technical solution: a biodegradable, anti-displacement fluorescent breast localization needle, comprising:
[0007] Needle sheath;
[0008] The puncture needle is placed inside the needle sheath, and the anchoring end of the puncture needle is fixed with multiple barbs arranged alternately in a left-right spiral direction along the axial direction.
[0009] The fixation patch is detachably adhered to the skin surface of the lesion site, and the needle sheath penetrates the fixation patch and is placed inside the body.
[0010] In a preferred embodiment, the outer surface of the barb is coated with a barium sulfate coating.
[0011] In a preferred embodiment, a fluorescent marker ball is fixed on the needle sheath near the needle tip.
[0012] In a preferred embodiment, the fluorescent marker sphere contains developing particles.
[0013] The technical effect of adopting the above-mentioned further solution is that it enables clear imaging under different imaging devices such as X-rays and ultrasound.
[0014] In a preferred embodiment, the puncture needle and barbs are integrally molded from polylactic acid.
[0015] The technical advantages of adopting the above-mentioned further solution are: by using biodegradable polylactic acid material, a second surgical removal is avoided after surgery, which increases patient pain and infection risk. At the same time, it avoids the possibility of inflammatory reactions caused by the long-term retention of the barbed parts in the body, and the need to separately remove the positioning needle from the specimen after the tumor is removed.
[0016] In a preferred embodiment, the adhesive patch includes a polyurethane substrate layer and a hydrocolloid adhesive layer disposed on the back side of the substrate layer.
[0017] The technical advantage of adopting the above-mentioned further solution is that by using a polyurethane film, it has high flexibility and fits the skin well.
[0018] In a preferred embodiment, a positioning pinhole is provided at the center of the fixing sticker and the adhesive layer.
[0019] The technical advantage of adopting the above-mentioned further solution is that it facilitates the insertion of the needle sheath, thereby allowing the needle sheath to be inserted into the breast lesion under ultrasound guidance.
[0020] In a preferred embodiment, the front side of the fixing sticker is provided with angle marks and fixing rings.
[0021] The technical effect of adopting the above-mentioned further solution is that it facilitates adjusting the angle of the needle sheath according to the location of the lesion along the angle mark.
[0022] In a preferred embodiment, the fixing ring is circular and is divided into at least four independently operable arc segments.
[0023] The technical effect of adopting the above-mentioned further solution is that the arc-shaped segment of the fixing ring fixes the needle sheath and the puncture needle, thereby enhancing the fixation effect.
[0024] Compared with the prior art, the advantages and positive effects of this utility model are as follows:
[0025] The barbs are coated with barium sulfate, and the needle sheath features fluorescent markers, ensuring clear visualization under various imaging devices such as X-rays and ultrasound. The barbs on the puncture needle, arranged in alternating left and right spirals, provide multi-directional anchoring to the breast tissue, resisting vertical / rotational displacement. The puncture needle is made of biodegradable polylactic acid, avoiding the need for a second surgery to remove it post-operatively, thus reducing patient pain and infection risks. It also avoids the potential for inflammation caused by prolonged retention of the barbs in the body, and the need to separately remove the positioning needle from the specimen after tumor removal. Attached Figure Description
[0026] Figure 1 A schematic diagram of the structure of a biodegradable, anti-displacement fluorescent mammography positioning needle provided by this utility model;
[0027] Figure 2 A schematic diagram of the puncture needle structure of a biodegradable, anti-displacement fluorescent mammography positioning needle provided by this utility model;
[0028] Figure 3 This is a schematic diagram of the fixing patch structure of a biodegradable anti-displacement fluorescent mammography positioning needle provided by this utility model.
[0029] Illustrations: 1. Needle sheath; 11. Fluorescent marker ball; 2. Puncture needle; 21. Barb; 3. Fixing tape; 31. Angle marker; 32. Fixing ring. Detailed Implementation
[0030] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.
[0031] like Figures 1-3 As shown, this embodiment provides a technical solution: a biodegradable, anti-displacement fluorescent breast localization needle, comprising: a tubular needle sheath 1 injection-molded from polylactic acid (PLA) material, which is entirely biodegradable; the needle sheath 1 is provided with graduated markings to facilitate the doctor's intraoperative location of the tumor according to the needle length; a fluorescent marker ball 11 is provided on the outer surface of the distal end (near the needle tip) of the needle sheath 1, made of silicone material containing a fluorescent agent (such as indocyanine green), and mixed with barium sulfate imaging particles inside. (Reference) Figure 1 As shown, a biodegradable polylactic acid puncture needle 2 is coaxially nested inside the needle sheath 1, for reference. Figure 2 As shown, the anchoring end (the end anchoring the lesion) of the puncture needle 2 is fixed with barbs 21 arranged alternately in a left-right spiral direction along the axial direction, in a "DNA double helix" shape. Each helical cycle contains several barbs, with a barb height of 0.3 mm and an inclination angle of 30°. The barbs 21 are designed with a "progressive height"—lower at the proximal end and higher at the distal end—to reduce puncture resistance and enhance the anchoring effect, forming multi-directional anchoring with human breast tissue and resisting vertical / rotational displacement. The surface of the barbs 21 is coated with a barium sulfate coating, manufactured through a spraying process, allowing for clear imaging under different imaging equipment such as X-rays and ultrasound. The puncture needle 2 has length graduations for easy observation of the puncture depth. The puncture needle 2 and barbs 21 are integrally formed using fused deposition modeling (FDM) 3D printing technology. The barbs 21 form multi-directional anchoring with breast tissue, resisting vertical / rotational displacement. (Reference) Figure 1 As shown, it also includes a fixation patch 3, which is specifically made of a polyurethane film coated with an antibacterial coating (such as chitosan). The use of a polyurethane film provides high flexibility and allows it to adhere well to the skin. A hydrocolloid adhesive layer is applied to the back of the substrate layer for adhesion to the skin surface. This adapts to the contours and movements of the skin, preventing deformation or damage, while also exhibiting good biocompatibility and no adverse effects on the human body, ensuring a secure fit. The fixation patch 3 contains antibacterial agents or uses an antibacterial coating to reduce the risk of skin infection. (Reference) Figure 3 As shown, both the base layer and the adhesive layer have positioning pin holes at their centers for inserting the needle sheath 1. The surface of the fixing patch 3 is printed with eight graduation lines using non-toxic ink and is equipped with digital indicators to facilitate accurate recording of the needle insertion angle by medical personnel during puncture. A fixing ring 32 is located on the surface of the fixing patch 3, outside the angle markings 31. The fixing ring 32 has a circular structure composed of four independent arc-shaped segments, each with an easy-tear line along its edge, allowing for individual peeling to adjust the fixing range.
[0032] Working principle:
[0033] like Figure 1-3 As shown:
[0034] Before the procedure, the patient should be positioned appropriately, and the operation should be performed according to aseptic principles. First, the fixation patch 3 is adhered to the patient's lesion projection area, and can be further secured with tape or bandage. The puncture needle 2 is inserted into the needle sheath 1. Under real-time ultrasound guidance, the needle sheath 1 is inserted through the positioning needle hole on the fixation patch 3. After confirming that the needle tip reaches the center of the lesion, the barbs 21 are unfolded for anchoring. X-ray imaging verifies that the barium sulfate contrast coating overlaps with the lesion. The spirally arranged barbs 21 and the fluorescent marker ball 11 on the needle sheath 1 form double contrast, significantly improving the visibility of the puncture path under X-ray and preventing needle displacement. Depending on the lesion location, the angle of the needle sheath 1 is adjusted along the angle mark 31. One or two arc-shaped segments of the fixation rings 32 are peeled off to fix the needle sheath 1 and the puncture needle 2, thereby enhancing the fixation effect. After the puncture, an elastic pressure bandage can be used normally. Within 1-2 weeks post-procedure, the polylactic acid puncture needle 2 gradually degrades, which improves the safety of puncture needle use, making it especially suitable for patients who will undergo elective surgery after puncture localization.
[0035] The above description is merely a preferred embodiment of the present utility model and is not intended to limit the present utility model in any other way. Any person skilled in the art may make changes or modifications to the above-disclosed technical content to create equivalent embodiments for application in other fields. However, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present utility model without departing from the technical solution of the present utility model shall still fall within the protection scope of the technical solution of the present utility model.
Claims
1. A degradable, anti-migration, fluorescently visualized breast localization needle, characterized in that, include: Needle sheath (1); The puncture needle (2) is placed inside the needle sheath (1), and the anchoring end of the puncture needle (2) is fixed with multiple barbs (21) arranged alternately in the left and right spiral directions along the axial direction. Fixation patch (3), which is detachably adhered to the skin surface of the lesion site, and the needle sheath (1) penetrates the fixation patch (3) and is placed in the human body.
2. The degradable anti-migration, fluorescently visualized breast localization needle of claim 1, wherein: The outer surface of the barb (21) is coated with a barium sulfate coating.
3. The degradable anti-migration, fluorescently visualized breast localization needle of claim 1, wherein: A fluorescent marker ball (11) is fixed on the needle sheath (1) near the needle tip.
4. The biodegradable, anti-displacement fluorescent breast localization needle according to claim 3, characterized in that: The fluorescently labeled sphere (11) contains developing particles.
5. The degradable anti-migration, fluorescently visualized breast localization needle of claim 1, wherein: The puncture needle (2) and the barb (21) are integrally molded polylactic acid structures.
6. The degradable anti-migration, fluorescently visualized breast localization needle of claim 1, wherein: The fixing patch (3) includes a polyurethane substrate layer and a hydrocolloid adhesive layer disposed on the back of the substrate layer.
7. The degradable anti-migration, fluorescently visualized breast localization needle of claim 6, wherein: The fixing sticker (3) and the center of the adhesive layer are provided with positioning pin holes.
8. The degradable anti-migration, fluorescently visualized breast localization needle of claim 7, wherein: Angle marks (31) and fixing rings (32) are respectively provided on the front side of the fixing sticker (3).
9. The degradable anti-migration, fluorescently visualized breast localization needle of claim 8, wherein: The fixing ring (32) is circular and is divided into at least four independently operable arc segments.