CN107029306A - A kind of mark that degraded support can be made to develop under X-ray and preparation method thereof - Google Patents
A kind of mark that degraded support can be made to develop under X-ray and preparation method thereof Download PDFInfo
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- CN107029306A CN107029306A CN201610080118.9A CN201610080118A CN107029306A CN 107029306 A CN107029306 A CN 107029306A CN 201610080118 A CN201610080118 A CN 201610080118A CN 107029306 A CN107029306 A CN 107029306A
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- mark
- support
- ray
- developing mark
- degraded
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
Abstract
The present invention relates to medical instruments field, more particularly to a kind of mark that degraded support can be made to develop under X-ray and preparation method thereof.Good tantalum is showed as the material for making developing mark using biocompatibility and development effect, pass through surface treatment, do not reducing its X-ray developability and improving its biocompatibility simultaneously, it is entirely avoided because different metal contacts the galvanic effect that (development point and degradable metal support) corrosion is brought.The present invention prepare sizes specification developing mark be placed on different size degraded support reserve hole site, after stenter to implant, with the progressively reconstruction and self-regeneration of implant site vascular function, the side of developing mark and upper and lower surface are tightly held onto by twine and blood vessel respectively, can have medication coat cladding on the surface of development point and support.The developing mark can bear prolonged vessel retraction motion and blood flow washes away and do not fallen off, with good medical safe and simple actual operability.
Description
Technical field
The present invention relates to medical instruments field, more particularly to a kind of mark that degraded support can be made to develop under X-ray
And preparation method thereof.
Background technology
As the improvement of people's living standards, the change of eating habit, work, the continuous increase of life stress,
Environmental pollution it is increasingly serious, the crowd for suffering from coronary heart diesease increasingly increases.Coronary heart disease is one kind because coronary artery is narrow
The organic disease of myocardial dysfunction caused by narrow, blood supply insufficiency, therefore also known as ischemic cardiomyopathy.It
It is a kind of clinically higher heart disease of the incidence of disease.Widely treated at present using the minimally invasive implantation of intravascular stent,
The technology technology such as inserts using puncture, conduit, inferior vena cava balloon dilation formation and endovascular stent, make it is narrow,
The blood vessel cavity of occlusion is expanded, led to again.
One very long process of the development experience of intravascular stent, at present clinically usage amount at most be inertia gold
Belong to the 316L supports and L605 supports being made.During long-term military service, support may cause the slow of blood vessel
Property damage, ultimately result in the generation of ISR.Due to being mainly the special time in wound healing after stenter to implant
It is interior that mechanical support effect is played to blood vessel (for coronary artery bracket, generally half a year).This period is spent, blood vessel
Reconstruction is finished, it is no longer necessary to support.Therefore, preferable coronary artery bracket should can be provided within half a year enough
Mechanical support then gradually degraded be absorbed by the body.So, the researcher of the association area proposes that manufacture can be with
The biodegradable stent being gradually absorbed by the body after effective service phase.
In recent years, the material of biodegradable stent concentrates on high molecule plastic material and degradable metal material two is led greatly
Domain.High molecule plastic mainly include polyglycolic acid/copolymer of poly lactic acid (PGLA), PLLA (PLLA),
PLA (PLA), polyhydroxybutyrate valerate (PAGA) pla-pcl (PCL) etc..Metal degradation support
It is then more with the magnesium alloy of light metal alloy.Clinical test results show that the support that both materials are made is in hand
Can not clearly it develop under X-ray in art implementation process, so that it cannot support is accurately placed at into focus portion
Position, causes operative failure.Additionally, due to not effective developing mark positioning, focus point untraceable, to disease
Paying a return visit to check for people can not also be carried out.
Existing many researchers did research to improving development capability of all kinds of degraded supports under X-ray at present.
Main method has：(1) in the method (201110409747.9) of macromolecule degraded support outer layer addition development coating；
(2) method (201010278678.8) of X-ray developing material is smeared in metal biodegradable stent inwall；(3)
The preformed hole on support, places corresponding effect good inertia developing mark such as platinum, gold etc..First two method is brought
The problem of have：(a) cohesive of development film and support base material must be firm, even if support experience pressure is held and expanded
Afterwards, both can not separate.(b) processing technology is complicated, especially for metal biodegradable stent.Compared with first two
Method, the third method is simpler easy.But in addition to having used expensive noble metal, can drop
Solve metallic support and noble metal developing mark corrosion potential difference is larger, once contact, equivalent to the metal branch of anode
Frame can occur rapidly to corrode and fail.As can be seen here, still had much for intervention support developing technique at present
Technological deficiency, still needs to further raising.
The content of the invention
It is an object of the invention to provide a kind of mark that degraded support can be made to develop under X-ray and preparation method thereof,
On the basis of validity in guarantee support under arms phase, all kinds of drops in current percutaneous coronary intervention are solved
The problem of solution support X-ray is underdeveloped.
In order to solve the shortcomings of the prior art, the technical scheme is that：
A kind of mark that degraded support can be made to develop under X-ray, developing mark body raw material are tantalum.
Described can make the mark that degraded support develops under X-ray, and developing mark body raw material surface is oxygen-rich layer,
Oxygen-rich layer is the oxide of tantalum, and thickness is between 100~1000nm.
The preparation method of the described mark that degraded support can be made to develop under X-ray, it is oxidation-treated after, development
Mark surface forms densification, the high resistant oxygen-rich layer that biocompatibility is good, oxidation temperature selection for 400~
700℃。
The preparation method of the described mark that degraded support can be made to develop under X-ray, sets pre- on degraded support
Box out, metal developing mark is embedded in preformed hole, marked body is stayed in preformed hole.
The preparation method of the described mark that degraded support can be made to develop under X-ray, developing mark is arranged at degraded
Preformed hole on the dowel of support two ends.
The preparation method of the described mark that degraded support can be made to develop under X-ray, developing mark size and thickness
It should be determined according to development effect and support twine thickness.
The preparation method of the described mark that degraded support can be made to develop under X-ray, developing mark thickness is less than branch
Frame twine thickness, it is ensured that development point upper and lower surface does not protrude support surfaces externally and internally；Developing mark size should be greater than
0.2mm, thickness should be greater than 0.05mm, to ensure development effect.
The present invention design philosophy be：
In order to solve the visualization problems of light metal support, present invention selection biological safety is preferable and in X-ray
The lower preferable high pure metal tantalum of development effect as developing mark raw material.In order to improve the biology of developing mark
Compatibility simultaneously thoroughly solves the stent failure that galvanic corrosion may be brought, and the present invention is used to be carried out to pure tantalum particle
The preparation method of surface oxidation treatment, it is development high-resistance, oxygen-enriched, that substrate is High-purity Tantalum to obtain surface
Mark.Oxidation temperature selection is 400~700 DEG C, and obtained developing mark body surface face is oxygen-rich layer, oxygen-enriched
Layer is the oxide of tantalum, and thickness is between 100~1000nm.The present invention is eventually through XRD and measures resistance
Mode verifies the validity of skin covering of the surface, determines handling process.
Whether developing mark can develop in vivo successfully also needs to determine its dimensions, modes of emplacement and quantity.This
Invention sets preformed hole using on degraded support, developing mark is embedded in preformed hole, marked body stays in reserved
Modes of emplacement in hole；By comparing different-thickness, external diameter is in the same size；External diameter is of different sizes, consistency of thickness；
External diameter is of different sizes, consistency of thickness, but the development effect of three different species samples of Technology for Heating Processing determines development
Label size specification；Through demonstration, the developing mark that the present invention is used is thinner than support radial direction twine thickness without exception, with
Ensure that mark is without projection in stent implantation procedure, make developing mark that clinically there is more preferable processing safety.
In order that developing mark clinically has more preferable multi-angle visible, the present invention is used in bracket end a bit
Or multiple-spot detection modes of emplacement.This new developing mark, can be such that support is accurately positioned under X-ray, development
The addition of mark does not influence support indices, does not bring additional risk, simple and easy to apply, workable, tool
It is with practical value.
Advantages of the present invention and beneficial effect are：
1st, the present invention shows good tantalum as the material for making developing mark using biocompatibility and development effect
Material, by surface treatment, is not reducing its X-ray developability and is improving its biocompatibility simultaneously, keeping away completely
Exempt from because different metal contacts the galvanic effect that (development point and degradable metal support) corrosion is brought.
2nd, the developing mark of the invention for preparing sizes specification is placed on the degraded support preformed hole of different size
Position, after stenter to implant, with the progressively reconstruction and self-regeneration of implant site vascular function, developing mark
Side and upper and lower surface tightly held onto by twine and blood vessel respectively, and can in development point and the surface of support
To there is medication coat cladding.The developing mark can bear the motion of prolonged vessel retraction and blood flow wash away without
Come off, with good medical safe and simple actual operability.
3rd, the present invention carries out oxidation processes on the surface of developing material, is improving developing mark biocompatibility simultaneously,
Fundamentally solve due to developing mark and galvanic effect caused by metal degradation support contact electromotive force,
Can safer, simple, the effective development available for different kind of material degraded support.It is of the invention involved
And developing mark can be used for the biodegradable stent of any types material, including high molecular polymer and metal can
Degraded support.
Brief description of the drawings
Fig. 1 is different size developing mark pictorial diagram of the present invention.
Fig. 2 is different size developing mark experiment in vitro development effect figure of the present invention.
Fig. 3 is the expansion of magnesium alloy biodegradable stent and developing mark riding position schematic diagram in embodiment 2.
Fig. 4 is that the present invention is internal development effect figure after AZ31 magnesium alloy biodegradable stent system marks.
Embodiment
In specific implementation process, mark of the invention that degraded support can be made to develop under X-ray and preparation method thereof,
It is specific as follows：
Marked body raw material are tantalum, and the purity of raw material tantalum should be in more than 99.9wt%.After oxidation-treated,
Developing mark surface forms densification, the more preferable high resistant oxygen-rich layer of biocompatibility.Oxidation temperature is selected
400~700 DEG C, depending on oxidization time is according to development point quantity.After oxidation processes, developing mark surface can not be
White powder material is observed under 10x magnifying glasses, superficial layer substance classes can be judged with XRD diffraction methods,
Ta can not be detected in the developing mark that the process of surface treatment of use is obtained2O5。
Wherein, developing mark is a kind of high resistant label with more preferable biocompatibility, is connect with other metals
When touching, marked body is in passive state all the time.Therefore, fundamentally solve due to marked body and metal class drop
Solve the galvanic effect that support contact occurs.
Wherein, multiple preformed holes can be set on degraded support, the developing mark is embedded in preformed hole, is marked
Body is stayed in preformed hole.Reserved hole site should be located on the dowel of support two ends, reserve hole number and position with reality
Comprehensive in the operation of border, various visual angles observation nonvisualization obstacle is basic norm.It is recommended that using different type support
When should consider that developing mark places quantity and position according to situations such as support length, thickness and military service position.
Wherein, dimension limit (the size and thickness) selection of developing mark should be according to single-point development effect.This hair
Bright preferred developing mark size should be greater than 0.2mm, and thickness should be greater than 0.05mm, to ensure in actual clinical
Development effect to be visually observed.
Wherein, developing mark size and the actual use size selection of thickness should be according to support twine thickness and structures
Design is determined.Developing mark thickness should be slightly less than support twine thickness, to ensure development point upper and lower surface
Do not protrude support surfaces externally and internally, developing mark does not cause to scratch support to tube wall in course of conveying in the blood vessels.It is aobvious
Shadow mark size, which is considered as support pressure, which holds, does not have obvious axial projection at rear developing mark, to avoid influenceing support
Pass through the ability of lesion.
Such scheme is further described below in conjunction with specific embodiment.It could be stated that these are implemented
Example is merely to illustrate the present invention and is not limited to the scope of the present invention.It is every based on the present invention, using tantalum as raw material
The research approach (behavior for doing equal changes and improvements) of progress, all should belong to the scope of the present invention.
Embodiment 1：
In the present embodiment, external development effect of its developing mark under medical X-ray refers to Fig. 1~2.Fig. 1
Shown four kinds of developing body surface treatment temperature (from left to right) in the latter half are respectively 300 DEG C, 400 DEG C, 700 DEG C
With 800 DEG C.The thickness of marker material is 0.040mm.The developing mark of four kinds of conditions is in the aobvious of medical X-ray
Shadow effect is showed well (see Fig. 2).Test result to its resistance shown in addition to 300 DEG C of sample resistances are smaller,
The resistance value of other three samples is infinity.XRD analysis are being carried out to aforementioned four sample, as a result table
Bright 800 DEG C of samples contain substantial amounts of Ta5O2.Actually superficial white powdered substance (see Fig. 2, naked eyes are visible).
The developing mark material obtained in 400 DEG C and 700 DEG C of intervals is the more excellent selection of the present invention.The development of different-thickness
Label diameter is 0.2mm, and its development effect is shown in Fig. 2 top halfs, in thickness 0.054mm~0.108mm
In the range of, diameter 0.2mm developing mark is high-visible.According to the above results, the size of developing mark
Design need to consider the size of three dimensions.
Preferably diameter 0.2mm, thickness 0.04mm of the invention size are used as the lower limit of developing mark, table
Face oxidation temperature control is between 400 DEG C~700 DEG C.Developing mark body raw material surface is oxygen-rich layer, rich
Oxygen layer is the oxide of tantalum, and thickness is between 100~1000nm.
Embodiment 2：
In the present embodiment, big animal experiment in vivo development effect reference of its developing mark under medical X-ray
Fig. 4.The present embodiment uses the common iliac artery of experimental animal pig to be marked as experiment blood vessel, support processing method and development
Remember manufacturing process as described in example 1 above.Difference is that the rack surface in this implementation will carry out medicine
The spray treatment of coating.Support twine thickness is 0.130mm, developing mark position diameter 0.38mm disk,
Its thickness is between 0.095~0.105mm.In the present embodiment, the oxygen-rich layer average thickness of developing mark is about
For 350nm.
In order to contrast development effect, the present embodiment demonstrates the development effect that developing mark is added in two kinds of positions.One
Plant is only to set a preformed hole respectively at the two ends of support.By two preformed holes and straight with support diameter parallel
The plane of line composition passes through the support cross section center of circle (see Fig. 3 solid dots position).Another is at support two ends point
Not She Zhi two developing mark preformed holes, often hold two preformed hole circle center line connectings be through the bracket cross section center of circle straight line,
The angle of two lines spatially is 90 °, and right-angled intersection state is spatially presented (see Fig. 3 in four development points
Hollow dots position).
The reserved aperture of two kinds of riding position supports is 0.40mm, and developing mark is by the way of manually adding
It is placed into the preformed hole for having sprayed coating stent of medicine.Most hold (conveying of balloon expandable system), envelope through pressure afterwards
Dress and sterilizing are prepared into complete medical intervention biodegradable stent system.Two kinds of mounting systems of the present embodiment are being planted
During entering, course of conveying is smooth, does not occur the phenomenon that support developing mark tilts deformation.After two months with
Visit in contrast examination, support position can be clearly accurately positioned on the video screen of X-ray (see figure
4)。
Claims (7)
1. a kind of mark that degraded support can be made to develop under X-ray, it is characterised in that developing mark body former material
Expect for tantalum.
2. the mark according to claim 1 that degraded support can be made to develop under X-ray, it is characterised in that
Developing mark body raw material surface is oxygen-rich layer, and oxygen-rich layer is the oxide of tantalum, and thickness is between 100~1000nm.
3. the preparation method for the mark that can make described in a kind of claim 1, degraded support developed under X-ray,
Characterized in that, after oxidation-treated, developing mark surface forms densification, the high resistant that biocompatibility is good
Oxygen-rich layer, oxidation temperature selection is 400~700 DEG C.
4. the preparation method of the mark according to claim 3 that degraded support can be made to develop under X-ray,
Characterized in that, setting preformed hole on degraded support, metal developing mark, marked body are embedded in preformed hole
Stay in preformed hole.
5. the preparation method of the mark according to claim 3 that degraded support can be made to develop under X-ray,
Characterized in that, developing mark is arranged at the preformed hole on the dowel of degraded support two ends.
6. the system for the mark that can make according to one of claim 3 to 5, degraded support developed under X-ray
Preparation Method, it is characterised in that developing mark size and thickness should be according to development effect and support twine thickness come really
It is fixed.
7. the preparation method of the mark according to claim 3 that degraded support can be made to develop under X-ray,
Characterized in that, developing mark thickness is less than support twine thickness, it is ensured that development point upper and lower surface does not protrude support
Surfaces externally and internally；Developing mark size should be greater than 0.2mm, and thickness should be greater than 0.05mm, to ensure development effect.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610080118.9A CN107029306B (en) | 2016-02-04 | 2016-02-04 | Marker capable of developing degradation stent under X-ray and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610080118.9A CN107029306B (en) | 2016-02-04 | 2016-02-04 | Marker capable of developing degradation stent under X-ray and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN107029306A true CN107029306A (en) | 2017-08-11 |
| CN107029306B CN107029306B (en) | 2020-05-15 |
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| CN201610080118.9A Active CN107029306B (en) | 2016-02-04 | 2016-02-04 | Marker capable of developing degradation stent under X-ray and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113633433A (en) * | 2021-10-15 | 2021-11-12 | 微创神通医疗科技（上海）有限公司 | Vascular implant |
| CN115212019A (en) * | 2022-07-20 | 2022-10-21 | 聚辉医疗科技(深圳)有限公司 | Blood vessel stent and preparation method thereof |
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| CN113633433A (en) * | 2021-10-15 | 2021-11-12 | 微创神通医疗科技（上海）有限公司 | Vascular implant |
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| CN107029306B (en) | 2020-05-15 |
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