CN105853036B - A kind of degradable personalized bionical medicament elution coronary stent of non-columnar - Google Patents
A kind of degradable personalized bionical medicament elution coronary stent of non-columnar Download PDFInfo
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- CN105853036B CN105853036B CN201610329746.6A CN201610329746A CN105853036B CN 105853036 B CN105853036 B CN 105853036B CN 201610329746 A CN201610329746 A CN 201610329746A CN 105853036 B CN105853036 B CN 105853036B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention belongs to technical field of medical instruments, and in particular to a kind of bionical medicament elution coronary stent of personalized non-columnar manufactured using degradation material.The support is the biodegradable stent made of degradable biomaterial；The support is made up of the waveform annular unit of some closures, and the network structure of bridge joint is fixedly connected to form between each annular unit；The support is implanted into direction according to it and is divided into proximal part and distal end, and the support, under expansion state, the external diameter of the support proximal part is different from the external diameter of the support distal end.The research and development of bionical degradable coronary artery bracket of the present invention are towards numerous patients with coronary heart disease, meet the trend of individualized treatment, from support shape is made up to the full extent many drawbacks brought are mismatched with blood vessel, avoid metallic support long-term existence that there is high science, economy and social value on influence caused by coronary artery.
Description
Technical field
The invention belongs to technical field of medical instruments, and in particular to a kind of non-columnar individual character manufactured using degradation material
Change bionical medicament elution coronary stent, and in particular to a kind of taper or special-shaped support.
Background technology
Coronary heart disease is one of common angiocardiopathy, has the high incidence of disease, death rate height, admission rate is high again, operation
The features such as complication is more.The treatment of coronary heart disease is the most important thing of cardiovascular disease therapies, and percutaneous coronary intervention is coronary heart disease
The important method for the treatment of.
Percutaneous coronary intervention experienced three milestone phases：Simple balloon expandable, the implantation of bare metal stent and
The implantation of bracket for eluting medicament.And in the existing mode clinically by percutaneous coronary intervention coronary heart disease, either naked branch
Frame or bracket for eluting medicament are still more based on metallic support.Although base metal composition, the polymer of existing metallic support
Carrier and anti-proliferative drugs all pass through many improvement, and achieve preferable clinical cure effect.But current gold
Category support still has the problem of two urgent need to resolve and annoyings the clinical treatment of coronary heart disease always：That is the metal material problem of support
Now standoff cylindrical-shaped structure problem.
On the one hand, long-term existence is needed after being intervened due to metallic support in intravascular, easily bring pole late period stent thrombosis,
The potential risks such as chronic inflammation, metallic support fracture, in-stent restenosis, cause patient's needs to take antiplatelet drug all the life
Thing, add the bleeding risk of patient.
Importantly, existing metallic support is to use cylindrical hollow configuration, cradle wall made of metal material at present
Connect and formed by metal truss bridge.Stent diameter after expansion is suitable with blood vessel diameter, and phase is selected according to lesion vesselses reference diameter
The support answered.The metallic support of deflation is sent to diseased region by doctor by arteries (femoral artery or radial artery), accurately
Metallic support is discharged by balloon expandable after positioning, under the effect of the pressure stent expansion, so as to which the tube chamber for releasing local is narrow
It is narrow, improve blood flow.But found in the Surgery of reality, because the coronary artery of human body is from coarse to fine to be in step by step
The distribution of existing the time, different Coronary Artery Lesions vessel positions and comes in every shape, and is especially got out in Left main artery end and descending anterior branch, convolution
Mouthful, it is frequently run onto clinically many lesion vesselses near-end and distal diameter is presented and differs greatly the tapered (blood of i.e. lesion locations
There is gap in pipe near-end to distal end tapers down, both ends diameter).And current data displays that, taper coronary artery
It is clinically very common.This results in the treatment for being directed to taper lesion patient, either using single-side stand or double
Support interventional technique, all in the presence of its drawback：During using single-side stand implantation toper coronary artery, because support and blood vessel diameter mismatch pole
It can easily cause support adherent bad or coronary artery interlayer, cause blood to be formed and the complication such as in-stent restenosis；And if using double
During stenter to implant taper coronary artery, it can cause the overlapping portion among two layers of support that tile is presented, this is undoubtedly added in support
The risk of thrombus or ISR, while also increase the overall expenses of PCI.In addition, increasing clinical lesion is presented
Go out coronary artery and the situation of special-shaped lesion occur because of pathologic conditions such as hemangiomas, this is also that traditional cylindrical support can't resolve
Problem.Therefore, needs can not be met in face of the situation of clinically common taper/special-shaped coronary artery, traditional single cylindrical stent.
It can be seen that for taper/abnormity specific form problem coronarius, current support material and structure can not expire
The demand of sufficient clinical treatment, therefore, develop meet patient's coronary morphology and lesion characteristic Novel individualized it is bionical can
Degraded coronary artery bracket, has considerable scientific value, economic value and social value.
The content of the invention
Therefore, the technical problems to be solved by the invention are that providing a kind of degradable personalized bionical medicine of non-columnar washes
De- coronary stent, to solve the problems, such as that coronary artery bracket material in the prior art and structure can not be satisfied with clinical practice.
In order to solve the above technical problems, the degradable personalized bionical medicament elution coronary artery of non-columnar of the present invention
Support, the support are the biodegradable stent made of degradable biomaterial；
The support is made up of the waveform annular unit of some closures, is fixedly connected to form between each annular unit
The network structure of bridge joint；The support intervenes direction according to it and is divided into proximal part and distal end, and the support is in expansion state
Under, the external diameter of the support proximal part is different from the external diameter of the support distal end.
Preferably, for the support under expansion state, the external diameter of the support proximal part is more than the support distal end
External diameter.
It is more excellent, the support under expansion state, its external diameter from the support telecentricity from proximal part to the support
End is gradually reduced, and forms the conical support of circular platform type structure.
For the support under expansion state, the external diameter of the support proximal part is bigger 0.1- than the external diameter of the support distal end
4cm。
The support is under expansion state, and the external diameter of the support proximal part is 2-5cm, the external diameter of the support distal end
For 1.5-4cm.
The trough and crest of the crest and wave trough position of the annular unit annular unit adjacent with both sides respectively
Position is corresponding to be fixedly connected, to form expandable network structure.
The support is the irregular special-shaped support according to Patients with Vasculopathy form Design.
The degradable biomaterial is PLLA.
The rack surface bag has the polymer for carrying anti-proliferative drugs.
It by mass ratio is 1 that the polymer, which is,:The mixture that 1 anti-proliferative drugs are formed with PDLLA.
The degradable personalized bionical medicament elution coronary stent of non-columnar of the present invention, is abandoned existing conventional
Cylindrical hollow supporting structure, can be according to the form of the situation individualized selection support of patient's lesion vesselses, such as taper knot
Structure support or special-shaped support, the narrow problem of the various form blood vessels such as taper or special-shaped blood vessel can be preferably released,
Avoid that support is adherent bad or interlayer caused by stent diameter and blood vessel diameter mismatch, and Thrombosis in sten, even
The appearance of the severe complications such as myocardial infarction.
The research and development of the bionical degradable coronary artery bracket of taper/abnormity of the present invention meet individual towards numerous patients with coronary heart disease
The trend of bodyization treatment, many drawbacks brought are mismatched with blood vessel from support shape is made up to the full extent, avoid metal branch
Frame long-term existence is expected to reduce the complication of Coronary Artery Disease Intervention Treatment, reduces the death rate, improve pre- on influence caused by coronary artery
Afterwards, revascularization rate again is reduced, patients ' life quality is improved, there is high scientific value.And of the present invention drop
The research and development of conical support are solved, is expected to can solve taper or special-shaped lesions treatment using single-side stand intervention, solves existing clinic
On usually need the problem of implanted diameter two pieces of supports of different sizes are to adapt to taper or special-shaped lesions treatment, save treatment
Overall expenses, there is fabulous economic value.
Biodegradable stent of the present invention, using degradable biomaterial -- left-handed polylactic acid (PLLA) is made, can be
Water and carbon dioxide are gradually degraded between implanting 2 years, the integrality of blood vessel and function is recovered to nature, will
The physiology income of uniqueness is provided for patient, revascularization can be repeated with position, the selection of openheart surgery is not limited, be easy to non-intruding
Property check such as MRI/CT, can effectively shorten the duplex antiplatelet time, promote the benign reconstruct of late vessel, reduction support in blood
The incidence of the complication such as bolt, chronic inflammation and support fracture, it is expected to save the life of more patients.
The degradable personalized bionical coronary artery bracket of non-columnar of the present invention, especially taper or special-shaped coronary artery bracket, is pushed away
The process of personalized coronary intervention has been moved, has been the individual character for the most source treatment meaning that China proposes in the world first
Change coronary artery bracket theory, to promoting China's coronary stent Strategic Readjustment, promote domestic coronary artery bracket progressively
Import substitutes are significant, while also reach to strive for China's calcification score individualized treatment and surmount the world
Advanced level, the 5th revolution of coronary intervention in world wide is led to lay the foundation for China.
Brief description of the drawings
In order that present disclosure is more likely to be clearly understood, specific embodiment and combination below according to the present invention
Accompanying drawing, the present invention is further detailed explanation, wherein,
Fig. 1 is a kind of radiography figure of taper coronary artery form lesion；
Fig. 2 is the structural representation of the taper coronary artery bracket of the present invention suitable for taper coronary artery symptom.
Embodiment
As shown in figure 1, giving the radiography figure of a clinical taper coronary conditions, coronary angiography figure circle shows in figure
Part shows that patient Left main artery-descending anterior branch diffuses lesion, but Left main artery lumen diameter about 4.5cm, descending anterior branch diameter about 2.0cm,
Taper pathological change form is presented.Pathological structure as depicted, if using traditional both ends lumen diameter identical cylinder gold
Category coronary artery bracket gives PCI, such as with this implantation toper coronary artery after, support may be caused adherent bad or interlayer, propped up
Thrombosis in frame, or even the appearance of the severe complication such as myocardial infarction, make treatment not thorough.
As shown in Fig. 2 give with reference to the knot with the suitable coronary stent used of coronary artery form Design shown in Fig. 1
Structure schematic diagram.
The support is hollow tubular structure, and expansion is may expand after blood vessel is intervened.The support by some closures ripple
Shape wave annular unit forms, and is fixedly secured to one another between each annular unit to form the network structure of bridge joint；As shown in Figure 2
Support in, the trough and crest of the crest and wave trough position of the annular unit annular unit adjacent with both sides respectively
Position is corresponding and is fixedly connected, to form expandable network structure.The overall structure of support shown in Fig. 2 and existing cylinder
The network structure of shape support is approximate.
Support of the present invention intervenes direction according to it and is divided into proximal part and distal end, typically in order to adapt to taper lesion
PCI, for the support under expansion state, the external diameter of the support proximal part is different from the external diameter of the support distal end；
And in the case of most lesions, the external diameter of the support proximal part is more than the external diameter of the support distal end.
In order to adapt to the PCI of taper lesion shown in Fig. 1, the support is under expansion state, and its external diameter is by described
The distal end of the proximal part of support to the support is gradually reduced, and forms the conical support of circular platform type structure.And the branch
Frame is under expansion state, and the external diameter (D) of the support proximal part is 4.5cm, and the external diameter (d) of the support distal end is 2cm；Institute
The external diameter for stating support proximal part is bigger 2-3cm than the external diameter of the support distal end.
Using the conical support of structure shown in Fig. 2 target lesion both ends can be made adherent more preferable, while distal end will not be because of branch
Frame diameter is excessive and causes vascular dissection, rupture.It can be seen that the structure of the support is more applied to the lesion shape of case shown in Fig. 1
State.
Meanwhile the coronary artery bracket is the biodegradable stent made of degradable biomaterial；It is preferred that the degradable life
Thing material is PLLA.Meanwhile the rack surface bag has the polymer for carrying anti-proliferative drugs, the polymer is by quality
Than for 1:The mixture that 1 anti-proliferative drugs are formed with PDLLA.The support PTCA or and STENTS, can voluntarily it degrade in vivo,
The integrality of blood vessel and function is set to recover to nature.
Coronary artery bracket adaptation taper pathological change form of the present invention focuses on outside the support proximal part and distal end
The difference in footpath, the influence and unobvious of the slightly morphological differences of the network structure that its cradle wall is formed in itself to PCI.
There is the patient that special-shaped vascular morphology is formed because of situations such as hemangioma for clinically even, traditional cylindrical stent is still
Can not solve its problem.Now it is contemplated that irregular special-shaped support according to Patients with Vasculopathy form Design.
By taking supporting structure shown in Fig. 2 as an example, manufactured using 3D printing technique, specific steps include：
According to Coronary Artery in patients radiography, the morphological data of lesion vesselses is obtained using QCA technologies, carries out personalized bionical coronary artery
Support Design：Configuration after being opened according to intravascular space diameter design intravascular stent, determines the specific configuration of intravascular stent, opens up
Structure and detailed design are flutterred, generates intravascular stent 3D data.And layered shaping is carried out to model using delamination software, generation 3D is beaten
Print the available individual-layer data of platform；
During using based on melting extrusion process forming, from a diameter of thread PLLA materials (a diameter of 1.2mm-3mm) or
Person's bulk PLLA materials, used using smelting process such as frictional force drives shower nozzle, screw rod shower nozzle, pneumatic sprayhead, stylus direct write shower nozzles
Shower nozzle, by the controlled extrusion of material, the representative diameter of shower nozzle wire vent is 50-300 μm, and specific wire vent diameter can be wanted according to support performance
Rooting is adjusted according to the conventional meanses and mode of this area.3D printing platform is completed under process software and control software control
The 3D printing of whole support.Can also material laser selective melting forming technology (SLM) or selective laser sintering forming technology
(SLS) it is used as 3D printing forming technology.Now PLLA materials are prepared into powdered, general powder diameter scope is 20-150 μ
m.SLS or SLM print platforms lay a thin layer material powder (thickness 0.05mm-0.2mm), laser on shaping bottom plate first
According to each layer cross section data under the control of special control software, selectively powder bed is scanned, by laser scanning
Region, powder particle occur softening or fusing and are bonded shaping, are not still in fluffy by the powder of laser scanning, can be used as branch
Support；After one layer machines, workbench decline one layer (thickness of setting) height, then carry out next layer of powdering and scanning until
Untill whole intravascular stent processes；
After the shaping of 3D printing technique print carriage, anti-proliferative drugs (such as everolimus) are coated on branch using traditional handicraft
Frame surface, have rack surface bag and carry the polymer of anti-proliferative drugs (polymer is medicine and PDLLA by 1:1 is mixed
Close).Can preferably solve abnormity stenotic lesion coronarius using personalized bionical bracket for eluting medicament of the invention.
And the method that biomimetic scaffolds are prepared using 3D printing technique, it is only necessary to designed according to the pathological structure of patient and situation
Go out suitable supporting structure, you can, only need to be according to the Conventional wisdom of those skilled in the art using the above method, simple adjustment
The argument structure of the support is prepared by the printing that different structure support can be achieved, and clinical therapeutic efficacy is especially prominent.
Obviously, above-described embodiment is only intended to clearly illustrate example, and is not the restriction to embodiment.It is right
For those of ordinary skill in the art, can also make on the basis of the above description it is other it is various forms of change or
Change.There is no necessity and possibility to exhaust all the enbodiments.And the obvious change thus extended out or
Among changing still in the protection domain of the invention.
Claims (2)
1. a kind of degradable personalized bionical medicament elution coronary stent of non-columnar, it is characterised in that the support is served as reasons
Biodegradable stent made of degradable biomaterial PLLA, the rack surface bag have the polymer for carrying anti-proliferative drugs；
It by mass ratio is 1 that the polymer, which is,:The mixture that 1 anti-proliferative drugs are formed with PDLLA；
The support is made up of the waveform annular unit of some closures, and bridge joint is fixedly connected to form between each annular unit
Network structure；The support is implanted into direction according to it and is divided into proximal part and distal end, and the support is under expansion state, institute
The external diameter for stating support proximal part is different from the external diameter of the support distal end；
For the support under expansion state, the external diameter of the support proximal part is more than the external diameter of the support distal end；The branch
Under expansion state, the distal end of its external diameter from proximal part to the support of the support is gradually reduced frame, and forms round platform
The conical support of type structure；
The trough and crest location of the crest and wave trough position of the annular unit annular unit adjacent with both sides respectively
It is corresponding to be fixedly connected, to form expandable network structure；
The support is under expansion state, and the external diameter of the support proximal part is 2-5mm, and the external diameter of the support distal end is
1.5-4mm；
For the support under expansion state, the external diameter of the support proximal part is bigger 0.1-4mm than the external diameter of the support distal end.
2. a kind of degradable personalized bionical medicament elution coronary stent of non-columnar, it is characterised in that the support is served as reasons
Biodegradable stent made of degradable biomaterial PLLA, the rack surface bag have the polymer for carrying anti-proliferative drugs；
It by mass ratio is 1 that the polymer, which is,:The mixture that 1 anti-proliferative drugs are formed with PDLLA；
The support is made up of the waveform annular unit of some closures, and bridge joint is fixedly connected to form between each annular unit
Network structure；The support is implanted into direction according to it and is divided into proximal part and distal end, and the support is under expansion state, institute
The external diameter for stating support proximal part is different from the external diameter of the support distal end；
The support is the irregular special-shaped support according to Patients with Vasculopathy form Design；
For the support under expansion state, the external diameter of the support proximal part is more than the external diameter of the support distal end.
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| CN106491174A (en) * | 2016-12-20 | 2017-03-15 | 北京久事神康医疗科技有限公司 | A kind of callable blood flow guider |
| US10568696B2 (en) | 2017-07-17 | 2020-02-25 | International Business Machines Corporation | Apparatus for supporting personalized coronary stents |
| CN113693680B (en) * | 2021-09-01 | 2023-06-16 | 南微医学科技股份有限公司 | Liner support |
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