CN208851651U - With locator markers made of degradable metal - Google Patents
With locator markers made of degradable metal Download PDFInfo
- Publication number
- CN208851651U CN208851651U CN201820512126.0U CN201820512126U CN208851651U CN 208851651 U CN208851651 U CN 208851651U CN 201820512126 U CN201820512126 U CN 201820512126U CN 208851651 U CN208851651 U CN 208851651U
- Authority
- CN
- China
- Prior art keywords
- locator markers
- magnesium
- locator
- positioning end
- marker
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Materials For Medical Uses (AREA)
Abstract
The utility model relates to one kind with locator markers made of degradable metal, the locator markers are made with pure magnesium or magnesium alloy, wherein, content of impurities is less than 0.01% mass fraction in pure magnesium and magnesium alloy, the locator markers are at least woven by three magnesium wires, and the positioning end for winding end with one and being connected to the winding end, the positioning end is claw-like or anchor-shaped structure, the tensile strength of the locator markers is greater than 200 megapascal, elongation after fracture is greater than 10%, internal degradation rate is less than 0.5mm/, the locator markers can develop under ultrasound and X-ray, surgical procedure and aftertreatment process can pass through ultrasonic or molybdenum target X-ray detection to the position of marker, and with the progress of aftertreatment, locator markers are gradually degraded, it is substantially absorbed into the surrounding tissues or is metabolized out human body, It is taken out without second operation.
Description
Technical field
The utility model relates to one kind be related to breast tissue in tumor of breast therapeutic process preoperative biopsy, in art excision with
And the locator markers of aftertreatment, especially one kind is with locator markers made of degradable metal.
Background technique
Since lesion is small, clinic can not touch Minute breast lesion, mark after biopsy sampling, is in surgical procedure and postoperative
It is required to precise positioning in treatment, avoids operation from cutting off excessive normal tissue, while ensuring the accuracy of diagnosing and treating.
Locator markers material used at present is generally titanium, titanium alloy or stainless steel material.For needing excision of performing the operation
Tumor of breast, marker can cut off together taking-up with lesion and part normal tissue.And for aftertreatment or biopsy after
It is not required to the patient of operation, marker can be retained in vivo for a long time.Existing locator markers are usually with nondegradable metal material
It is made, it is thus possible to bring foreign body sensation to patient, it is also possible to be moved to other positions, or even second operation is needed to take out label
Object brings potential risks and hidden danger to patient.
Degradable pure magnesium and magnesium alloy biomaterials have good medical prospect, after being implanted into human body and in surrounding tissue
The water gradually degradation that reacts form magnesium ion or other alloy ions, final metabolism excretes.It is suitable by selecting
Alloying element and control impurity content in metal, can control the degradation rate and biological safety of magnesium alloy, avoid degrading
It is too fast that marker is caused to disappear or introduce in advance under image potential biological safety risk, marker can also be thrown
Light or surface prepares coating adjust the degradation rate of pure magnesium and magnesium alloy materials, improve biocompatibility, meet different treatment mesh
Demand.
Inventor is in view of this, be applied to locator markers by using degradable pure magnesium or magnesium alloy materials, to solve
Defect existing for certainly existing locator markers.
Utility model content
It is made, may be brought to patient in order to solve existing locator markers using nondegradable metal or alloy material
Foreign body sensation, it is also possible to be moved to other positions, or even second operation is needed to take out marker, bring potential risks to patient
And hidden danger, the main purpose of the utility model is to provide one kind with locator markers made of degradable metal, and described determines
Position marker is made with pure magnesium or magnesium alloy, wherein less than 0.01% mass fraction, described determines content of impurities in magnesium alloy
Position marker is at least knitted to form positioning end by three magnesium wires, which can be fixed on inside of human body with positioning end,
And gradually degrade at any time, it is substantially absorbed into the surrounding tissues or is metabolized out human body, is taken out without second operation.
The utility model with technological means be to provide it is a kind of with locator markers made of degradable metal, packet
It has included:
One marker ontology, the strip that at least three magnesium wires are entwined as made by pure magnesium wire or magnesium alloy
Structure, one end of the marker ontology form the winding end wound each other, and the other end forms the positioning end separated each other, should
Positioning end is for being fixed on tissue.
It is preferred that the locator markers, used by pure magnesium wire or magnesium alloy content of impurities be less than
0.01% mass fraction.
Preferably, the locator markers, described in locator markers tensile strength be greater than 200 megapascal, break
Elongation is greater than 10% afterwards, and internal degradation rate is less than 0.5mm/.
Preferably, the locator markers, the positioning end of the marker ontology are mutually in that 120 degree of angles uniformly divide
Cloth, the positioning end and the winding end touching position are pre-bent into certain radian.
Preferably, the locator markers, the long axis of positioning end relative index's object ontology of the marker ontology
The anchor-shaped structure for the inverted V-shaped that about 135 degree~165 degree of outward bending.
It is preferably the locator markers, which is characterized in that the length of the positioning end accounts for the marker ontology overall length
The one third of degree is to a quarter.
The utility model using provided with locator markers made of degradable metal, the effect of can obtaining enhancement
Include:
1, the locator markers are made with pure magnesium or magnesium alloy, can be developed under ultrasound and X-ray, surgical procedure and art
Therapeutic process can be by ultrasound or molybdenum target X-ray detection to the position of marker afterwards, and can remove table by electrochemical polish
Face oxide layer, or the degradation rate of magnesium alloy is adjusted in surface prepares coating, improve biocompatibility.
2, locator markers can be firmly attached in tissue with positioning end, be not susceptible to shift, and be controlled with subsequent
The progress for the treatment of, locator markers are gradually degraded with the time, are substantially absorbed into the surrounding tissues or are metabolized out human body, take without second operation
Out, wherein the compressible deformation of the positioning end of locator markers is simultaneously sprung back, and can form claw-like or anchor-shaped, can effectively be grabbed
It takes in tissue and not easily to fall off or displacement.
Detailed description of the invention
Fig. 1 is the outside drawing of the first preferred embodiment of the utility model.
Fig. 2 is the outside drawing of second preferred embodiment of the utility model.
Fig. 3 is the flow chart of the locator markers preparation method of the utility model.
Specific embodiment
In order to understand the technical characteristics of the utility model and practical effect in detail, and can come according to the content of specification
Implement, further with preferred embodiment as shown in drawings, detailed description is as follows, please refers in first preferred embodiment as schemed
It include a marker ontology 10A with locator markers made of degradable metal shown in 1.
The length of marker ontology 10A be 10~20mm, outer most edge 1~3mm of diameter, marker ontology 10A be by
The strip structure that at least three magnesium wires are entwined made by pure magnesium wire or magnesium alloy, it is preferred that by each magnesium wire
Diameter 0.5mm~0.8mm.
One end of marker ontology 10A forms winding the end 11A, winding end 11A wound each other and can puncture with one
Push rod location contacts in needle cannula form the positioning end 12A separated each other in the other end of marker ontology 10A, and composition should
Each magnesium wire of positioning end 12A is mutually in about 120 degree of equally distributed claw-like structures of angle, positioning end 12A and winding end 11A
Touching position is pre-bent into certain radian.The length of positioning end 12A accounts for the one third of the marker ontology 10A total length
To a quarter, makes positioning end 12A there is enough length to be capable of forming and be conducive to the fixed shape of crawl, the locator markers
Tensile strength be greater than 200 megapascal, elongation after fracture be greater than 10%, internal degradation rate be less than 0.5mm/.
The application method of the utility model first preferred embodiment is as follows, and marker ontology 10A is put into one when use
In puncture needle casing, push a push rod of the puncture needle casing marker ontology 10A can be launched in anchor point, the label
The positioning end 12A of object ontology 10A is pierced into breast tissue and fixation under thrust, since the marker ontology 10A is pure magnesium
Made by silk or magnesium alloy, it can develop under ultrasound and X-ray, surgical procedure and aftertreatment process can pass through ultrasound or molybdenum target
X-ray detection is to the position of marker ontology 10A.With the progress of aftertreatment, marker ontology 10A can with the time by
It gradually degrades, average internal degradation rate is lower than 0.5 millimeter/year, it is preferred that average internal 0.15 millimeter/year of degradation rate~
0.38 millimeter/year.
The second embodiment of the utility model is as shown in Fig. 2, it is roughly the same with first preferred embodiment embodiment, difference
It is, the positioning end 12B shape of marker ontology 10B, one end of marker ontology 10B is winding end 11B, separately
One end is positioning end 12B, and the length of positioning end 12B accounts for the one third of the marker ontology 10B total length to a quarter,
Second preferred embodiment forms about 135 degree of long axis outward bending of each magnesium wire relative index object ontology 10B of positioning end 12B
~165 degree, and form the anchor-shaped structure of inverted V-shaped, wherein in space in 120 degree of angles between each magnesium wire of positioning end 12B
Be uniformly distributed, application method it is roughly the same with the first preferred embodiment, not in this to go forth.
As shown in figure 3, the utility model is used to prepare the preparation method of the locator markers of the first, second preferred embodiment
In, step includes magnesium wire forming S1, locator markers forming S2, surface treatment S3.
Magnesium wire forming step S1: material can be selected from pure magnesium material, can be commercially available pure magnesium ingot casting, and content of magnesium is greater than 99.99%
Mass fraction, other impurities ingredient such as iron, silicon, nickel, copper, aluminium, manganese, zinc impurity total content, or can less than 0.01% mass fraction
The selection of material is for example pure magnesium zinc calcium alloy of magnesium alloy materials, wherein content of magnesium is greater than 99% mass fraction, Zn content about 0.87%
Mass fraction, calcium content about 0.046%, other impurities such as aluminium, copper, iron, manganese, nickel, about 0.008% mass of silicon impurities total content point
Number, the pure magnesium material do not need solution heat treatment, the magnesium alloy materials need to after solution heat treatment, take extruding, drawing,
It swages and waits deformation techniques, obtain tensile strength and be greater than the silk material of 200 megapascal, elongation after fracture greater than 10%.The method of smelting
Including but not limited to atmosphere protection melting, vacuum melting.The selection of alloying element fully considers biological safety, the utility model
In magnesium alloy materials be preferably magnesium-zinc alloy, magnesium calcium alloy, magnesium zinc calcium alloy, to avoid or control aluminium, zirconium, manganese, rare earth etc.
Alloying element content.
When material can be selected from pure magnesium material, used pure magnesium ingot casting is squeezed into diameter 1 after 250 degree of heat preservations in 3 hours
~2mm silk material, extrusion ratio 16:1, extruding rate 0.5mm/s.By the silk material of extruding further across 16~40 passage hot pull works
Skill is processed into diameter 0.5mm silk material.The tensile strength of this silk material can reach 220 megapascal, elongation after fracture 12%.
When material can be selected from magnesium alloy materials, used magnesium alloy ingot after 350 degree of solution heat treatment in 16 hours,
It is squeezed into diameter 12mm bar, squeezes 330 degree of temperature, extrusion ratio 17:1, extruding rate 0.33mm/s.The bar of extruding is through 22
Secondary swage obtains diameter 0.8mm silk material.This 230 megapascal of silk material tensile strength, elongation after fracture 11.5%.
Locator markers shape S2: being wound at least three one end using magnesium wire forming step S1 silk material formed thereby
Become locator markers together, one end of locator markers forms winding end, outwardly or inwardly bends to certain angle in the other end
Degree, to form the positioning end of claw-like or anchor-shaped.
Be surface-treated S3: the locator markers can remove surface oxide layer by electrochemical polish, or in surface system
The degradation rate that magnesium alloy is adjusted for coating, improves biocompatibility.
Preferably, when the locator markers are handled its surface using the method for electrochemical polish, anode is
Locator markers, cathode are stainless steel electrode.0 degree of polish temperature, voltage 7V, the polishing fluid used is the anhydrous second of volume 8:1
Alcohol and perchloric acid, additive are the citric acid of 1.5g/L and the glucose solution of 0.3g/L.After polishing in 30 seconds, mark positioning
Note object surface forms bright mirror finish layer.Telltale mark after being dried using washes of absolute alcohol as implantation breast tissue
Object uses.
When locator markers are surface-treated by the way of prepares coating, coat type is degradable macromolecule material
Material or magnesia, magnesium hydroxide coating, avoid the bio-ceramic coating of calcic, P elements, prevent group again after calcium, P elements degradation
Knit middle deposition.The preparation method of coating includes but is not limited to self assembly, coating, alkali heat-treatment, chemical oxidation.
Preferably, a polylactic acid coating is prepared on locator markers surface, method is as follows, and locator markers are in anhydrous second
Electrobrightening 2min in pure and mild perchloric acid mixed polishing solution, is added with removing surface oxide layer and swaging by 25 degree of temperature, voltage 10V
Work trace.It is dried after polishing with washes of absolute alcohol, thickness is then prepared on the locator markers surface using the method for spraying
About 10~30 microns of polylactic acid coating.
Use example difference with the preparation method of the utility model locator markers is as follows:
With locator markers 10A as shown in Figure 1 is made, commercially available pure magnesium ingot casting is used, content of magnesium is greater than 99.99%
Mass fraction, iron, silicon, nickel, copper, aluminium, manganese, zinc impurity total content are less than 0.01% mass fraction.The ingot casting is small through 250 degree 3
Diameter 1~2mm silk material is squeezed into after Shi Baowen, extrusion ratio 16:1, extruding rate 0.5mm/s further pass through the silk material of extruding
It crosses 16~40 passage hot-pull techniques and is processed into diameter 0.5mm silk material, this 220 megapascal of silk material tensile strength, elongation after fracture
12%.
By above-mentioned Wire-winding at locator markers 10A shown in FIG. 1 after, using the method for electrochemical polish to its surface
Handled: anode is marker, and cathode is stainless steel electrode.0 degree of polish temperature, voltage 7V, the polishing fluid used is volume
The dehydrated alcohol and perchloric acid of 8:1, additive are the citric acid of 1.5g/L and the glucose solution of 0.3g/L.It was polished through 30 seconds
Afterwards, marker surface forms bright mirror finish layer.Mark after being dried using washes of absolute alcohol as implantation breast tissue
Remember that object uses.
With locator markers 10B as shown in Figure 2 is made, raw material are pure magnesium ingot casting, zinc granule, calcium block, using true
Empty melting obtains 0.87% mass fraction of Zn content, and 0.046% mass fraction of calcium content, aluminium, copper, iron, manganese, nickel, silicon impurities are total
0.0080% mass fraction of content.The ingot casting is squeezed into diameter 12mm bar after 350 degree of solution heat treatment in 16 hours, squeezes
330 degree of temperature of pressure, extrusion ratio 17:1, extruding rate 0.33mm/s.The bar of extruding swages through 22 passages and obtains diameter 0.8mm
Silk material.This 230 megapascal of silk material tensile strength, elongation after fracture 11.5%.
By above-mentioned Wire-winding at locator markers 10B shown in Fig. 2 after, polylactic acid coating is prepared on its surface, makes this
Locator markers 10B electrobrightening 2min in dehydrated alcohol and perchloric acid mixed polishing solution, 25 degree of temperature, voltage 10V, with
Removal surface oxide layer and cutter trade of swaging.It is dried after polishing with washes of absolute alcohol, is then being marked using the method for spraying
Note object surface prepares about 10~30 microns of thickness of polylactic acid coating.
The above is only the preferred embodiment of the utility model, not makees limit in any form to the utility model
System, any technical field those of ordinary skill, if in the range of not departing from the utility model mentioned technical characteristic, utilization
The equivalent embodiment for locally changing or modifying made by the utility model disclosed technology content, still falls within the utility model skill
In the range of art feature.
Claims (6)
1. one kind is with locator markers made of degradable metal characterized by comprising
One marker ontology, the strip knot that at least three magnesium wires are entwined as made by pure magnesium wire or magnesium alloy
Structure, one end of the marker ontology form the winding end wound each other, and the other end forms the positioning end separated each other, this is fixed
Position end is for being fixed on tissue.
2. locator markers according to claim 1, which is characterized in that impurity is total in used pure magnesium wire or magnesium alloy
Content is less than 0.01% mass fraction.
3. locator markers according to claim 2, which is characterized in that the tensile strength of the locator markers is greater than
200 megapascal, elongation after fracture are greater than 10%, and internal degradation rate is less than 0.5mm/.
4. locator markers according to claim 1, which is characterized in that the positioning end of the marker ontology is mutually in maximum
120 degree of angles are uniformly distributed, and the positioning end and the winding end touching position are pre-bent into certain radian.
5. locator markers according to claim 1, which is characterized in that positioning end relative index's object of the marker ontology
The anchor-shaped structure of about 135 degree~165 degree of long axis outward bending of inverted V-shaped of ontology.
6. locator markers according to any one of claim 1 to 5, which is characterized in that the length of the positioning end accounts for this
The one third of marker ontology total length is to a quarter.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201820512126.0U CN208851651U (en) | 2018-04-11 | 2018-04-11 | With locator markers made of degradable metal |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201820512126.0U CN208851651U (en) | 2018-04-11 | 2018-04-11 | With locator markers made of degradable metal |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN208851651U true CN208851651U (en) | 2019-05-14 |
Family
ID=66410609
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201820512126.0U Active CN208851651U (en) | 2018-04-11 | 2018-04-11 | With locator markers made of degradable metal |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN208851651U (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108378929A (en) * | 2018-04-11 | 2018-08-10 | 西安卓恰医疗器械有限公司 | With locator markers and preparation method thereof made of degradable metal |
| CN111481272A (en) * | 2020-05-14 | 2020-08-04 | 北京大学第三医院（北京大学第三临床医学院） | Ultrasonic guided puncture positioning guide line and manufacturing method thereof |
-
2018
- 2018-04-11 CN CN201820512126.0U patent/CN208851651U/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108378929A (en) * | 2018-04-11 | 2018-08-10 | 西安卓恰医疗器械有限公司 | With locator markers and preparation method thereof made of degradable metal |
| CN111481272A (en) * | 2020-05-14 | 2020-08-04 | 北京大学第三医院（北京大学第三临床医学院） | Ultrasonic guided puncture positioning guide line and manufacturing method thereof |
| CN111481272B (en) * | 2020-05-14 | 2022-04-12 | 北京大学第三医院（北京大学第三临床医学院） | Ultrasonic guided puncture positioning guide line and manufacturing method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN108378929A (en) | With locator markers and preparation method thereof made of degradable metal | |
| CN105925847B (en) | A kind of biodegradable zinc-base metal material and the ureterectasia stent obtained using the material | |
| CN201617885U (en) | Absorbable magnesium alloy staple used for anastomat | |
| RU2754035C2 (en) | Magnesium alloy, method for its production and use | |
| CN208851651U (en) | With locator markers made of degradable metal | |
| KR102626287B1 (en) | Magnesium based absorbent alloy | |
| EA029095B1 (en) | Biodegradable implantable medical device formed from super-pure magnesium-based material | |
| EP1600179A2 (en) | Implant for vascular ligature | |
| CN213076762U (en) | Degradable metal anastomosis nail | |
| EP2399619B1 (en) | Implant and Method for Manufacturing Same | |
| CN107736906A (en) | A kind of Absorbale magnesium alloy skin closure nail and preparation method thereof | |
| CN105087980A (en) | Method for preparing hemostatic clips through surface-passivated degradable magnesium alloy | |
| KR20230028224A (en) | Manufacturing method of magnesium alloy wire for biomedical use | |
| CN109330674B (en) | Internal fixing system and using method thereof | |
| CN110144534A (en) | A kind of preparation method of making Nano surface magnesium alloy anastomosis staple | |
| EP2399620A2 (en) | Implant and method for producing the same | |
| JP6823321B2 (en) | Bioabsorbable staple | |
| CN109811265A (en) | A kind of Fe-Mn-Cu-C system alloy and its medical application | |
| EP2227261B1 (en) | Tungsten alloy suture needles with surface coloration | |
| CN108714252B (en) | Preparation method of magnesium alloy fixing screw capable of being degraded controllably in vivo | |
| EP1948063B1 (en) | Marker for marking an area in body tissue | |
| CN111388764B (en) | Degradable metal anastomosis nail and preparation method thereof | |
| CN206979842U (en) | A kind of cardiac pacemaker current provides unit and device | |
| CN211355769U (en) | Multifunctional heart interval tubular puncture device | |
| CN108607114B (en) | Medical degradable magnesium alloy suture line and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant |