A kind of degradable personalization non-columnar bionical medicament elution coronary stent
Technical field
The invention belongs to technical field of medical instruments, be specifically related to a kind of utilize degradation material to manufacture
The personalized bionical medicament elution coronary stent of non-columnar, is specifically related to a kind of taper or abnormity support.
Background technology
Coronary heart disease is one of common cardiovascular disease, has sickness rate height, mortality rate height, again enters
The features such as institute leads height, and postoperative complication is many.The treatment of coronary heart disease is the most important thing of cardiovascular disease therapies,
Percutaneous coronary intervention is the important method of coronary heart disease treatment.
Percutaneous coronary intervention experienced by three milestone phase: simple balloon expandable, bare metal props up
The implantation of frame and the implantation of bracket for eluting medicament.And it is existing clinically by percutaneous coronary intervention hat
In the mode of cardiopathia, either bare bracket or bracket for eluting medicament are still many based on metal rack.
Although the base metal composition of existing metal rack, polymer carrier and anti-proliferative drugs are all through all
Many improvement, and achieve preferable clinical cure effect.But, current metal rack still has
Two difficult problems needing solution badly also annoying the clinical treatment of coronary heart disease always: i.e. the metal material of support
Problem and existing standoff cylindrical-shaped structure problem.
On the one hand, need long-term existence in Ink vessel transfusing after getting involved due to metal rack, easily bring extremely evening
The potential risks such as the fracture of phase stent thrombosis, chronic inflammatory disease, metal rack, in-stent restenosis, cause
Patient needs to take all the life antiplatelet drug, adds the bleeding risk of patient.
The more important thing is, the cylindrical, hollow knot that current existing metal rack metal material is made
Structure, cradle wall is connect by metallic steel beam bridge and forms.Stent diameter after expansion is suitable with blood vessel diameter, root
Corresponding support is selected according to lesion vessels reference diameter.By arteries, (femoral artery or oar move doctor
Arteries and veins) metal rack of deflation is sent to diseased region, by balloon expandable by metal after being accurately positioned
Support discharges, stent expansion under the effect of the pressure, thus releases the luminal stenosis of local, improves blood
Stream.But find in actual Surgery, owing to the coronary artery of human body is from coarse to fine
Present the distribution of the time step by step, different Coronary Artery Lesions vessel positions and coming in every shape, especially at Left main artery
End and anterior descending branch, Circumflex branch opening, be frequently run onto the most many lesion vesselses present near-end with
Distal diameter differs greatly, and tapered (blood vessel near-end to distal end tapers down, two ends are straight for i.e. lesion locations
There is gap in footpath) situation.And current data displays that, taper coronary artery right and wrong clinically
Usually see.This results in the treatment being directed to taper pathological changes patient, either use single-side stand or
, all there is its drawback: when using single-side stand implantation toper arteria coronaria, due to support in double bracket interventional technique
Do not mate with blood vessel diameter and support easily can be caused adherent bad or arteria coronaria interlayer, cause blood to be formed and prop up
The complication such as restenosis in frame;And if when using double bracket implantation toper arteria coronaria, two-layer can be caused to prop up
Overlapping portion in the middle of frame presents tile, and this adds the risk of thrombus in stents or restenosis undoubtedly,
Too increase the overall expenses of interventional therapy simultaneously.It addition, increasing clinical pathological changes presents hat
There is the situation of special-shaped pathological changes because of pathologic conditions such as hemangioma in arteries and veins, and this is also traditional cylindrical support institute
The problem that can't resolve.Therefore, in the face of the situation of the most common taper/abnormity arteria coronaria, traditional
Single cylindrical stent cannot meet needs.
Visible, for taper/special-shaped specific form problem coronarius, current support material and knot
Structure cannot meet the demand of clinical treatment, therefore, develops and meets patient's coronary morphology and disease
The Novel individualized bionical degradable coronary artery bracket of change feature, has considerable scientific value, warp
Ji is worth and social value.
Summary of the invention
To this end, the technical problem to be solved is to provide a kind of degradable personalized non-post
Shape bionical medicament elution coronary stent, equal to solve coronary artery bracket material and structure in prior art
The problem that can not be satisfied with clinical practice.
For solving above-mentioned technical problem, the degradable bionical medicine of personalization non-columnar of the present invention is washed
De-coronary stent, described support is the biodegradable stent being made up of degradable biomaterial;
Described support is made up of the waveform annular unit of some Guan Bis, solid between each described annular unit
Fixed connection forms the network structure bridged;Described support is got involved direction according to it and is divided into proximal part and telecentricity
End, and described support is under expansion state, the external diameter of described support proximal part and described support distal end
External diameter different.
Preferably, described support is under expansion state, and the external diameter of described support proximal part is more than described
The external diameter of frame distal end.
More excellent, described support under expansion state, its external diameter by the proximal part of described support to described
The distal end of support is gradually reduced, and forms the conical support of circular platform type structure.
Described support is under expansion state, and the external diameter of described support proximal part is than described support distal end
The big 0.1-4cm of external diameter.
Described support is under expansion state, and the external diameter of described support proximal part is 2-5cm, and described support is remote
The external diameter of heart end is 1.5-4cm.
The ripple of the described annular unit that the crest of described annular unit and wave trough position are adjacent with both sides respectively
Paddy fixing connection corresponding with crest location, to form expandable network structure.
Described support is the irregular special-shaped support according to Patients with Vasculopathy form Design.
Described degradable biomaterial is PLLA.
Described rack surface bag has the polymer carrying anti-proliferative drugs.
Described polymer is the mixture formed with PDLLA by the anti-proliferative drugs that mass ratio is 1:1.
Degradable personalization non-columnar of the present invention bionical medicament elution coronary stent, abandons
Existing conventional cylindrical hollow supporting structure, can select according to the situation personalization of patient's lesion vessels
Select the form of support, such as pyramidal structure support or abnormity support, can preferably release and such as bore
Shape or the narrow problem of the abnormity various form blood vessels such as blood vessel, it is to avoid stent diameter and blood vessel diameter are not
Join that the support caused is adherent bad or interlayer, and Thrombosis in sten, even myocardial infarction etc. are tight
The appearance of weight complication.
The research and development of bionical taper of the present invention/abnormity degradable coronary artery bracket are towards numerous coronary disease sufferers
Person, meets the trend of individualized treatment, makes up support shape and blood vessel not matching strip to the full extent
The many drawbacks come, it is to avoid the impact that arteria coronaria is produced by metal rack long-term existence, are expected to reduce coronary disease
The complication of sick interventional therapy, reduces mortality rate, improves prognosis, reduce myocardial revascularization rate again, carry
High patients ' life quality, has high scientific value.And degradable conical support of the present invention
Research and development, be expected to use single-side stand get involved can solve taper or abnormity lesions treatment, solve existing
The most usually need two pieces of supports that implanted diameter varies in size to adapt to taper or abnormity lesions treatment
Problem, save treatment overall expenses, there is fabulous economic worth.
Biodegradable stent of the present invention, uses degradable biomaterial--left-handed PLA (PLLA)
Make, can gradually be degraded to water and carbon dioxide between 2 years implanting, make blood vessel integrity and
Function is recovered to naturalness, by providing the physiology income of uniqueness for patient, can repeat with position
Myocardial revascularization, is not intended to the selection of operation on heart, it is simple to non-intrusive inspection such as MRI/CT etc., can
Effectively shorten the duplex antiplatelet time, the promotion optimum reconstruct of late vessel, reduction thrombus in stents,
The incidence rate of the complication such as chronic inflammatory disease and support fracture, is expected to save the life of more patient.
The degradable bionical coronary artery bracket of personalization non-columnar of the present invention, especially taper or abnormity hat
Pulsation frame, has promoted the process of personalized coronary intervention, is that China proposes the most in the world
Most there is the personalized coronary artery bracket theory of source innovative significance, produce promoting China's coronary stent
Industry structure strategical adjustment, promotes that domestic coronary artery bracket progressively import substitutes are significant,
Simultaneously the most also reach and surmount international most advanced level for striving for China's calcification score individualized treatment, for
China leads the 5th revolution of coronary intervention in world wide to lay the foundation.
Accompanying drawing explanation
In order to make present disclosure be more likely to be clearly understood, below according to the concrete reality of the present invention
Executing example and combine accompanying drawing, the present invention is further detailed explanation, wherein,
Fig. 1 is the radiography figure of a kind of taper arteria coronaria form pathological changes;
Fig. 2 is the structural representation of the taper coronary artery bracket being applicable to taper arteria coronaria symptom of the present invention
Figure.
Detailed description of the invention
As it is shown in figure 1, i.e. give the radiography figure of an example clinic taper coronary conditions, figure is preced with
Arteries and veins radiography figure circle shows that part display patient's Left main artery-anterior descending branch fills the air pathological changes, but Left main artery lumen diameter is about
4.5cm, anterior descending branch diameter about 2.0cm, present taper pathological change form.Pathological structure as depicted,
If the cylindrical metal coronary artery bracket using traditional two ends lumen diameter identical gives interventional therapy,
After with this implantation toper coronary artery, it is likely to result in that support is adherent bad or interlayer, thrombus in stents
The appearance of the severe complications such as formation, even myocardial infarction, makes treatment the most thorough.
As in figure 2 it is shown, give with reference to the suitable use of arteria coronaria form Design shown in Fig. 1 is crown
The structural representation of arterial bracket.
Described support is hollow tubular structure, inflatable expansion after getting involved blood vessel.If described support by
The waveform annular unit composition of dry Guan Bi, is fixedly secured to one another between each described annular unit to be formed
The network structure of bridge joint;In support as shown in Figure 2, the crest of described annular unit and wave trough position
The trough of described annular unit adjacent with both sides respectively and crest location is corresponding and fixing connection, with
Form expandable network structure.The overall structure of the support shown in Fig. 2 and existing cylinder racks
Network structure approximates.
Support of the present invention be got involved direction according to it and is divided into proximal part and distal end, typically in order to adapt to
The interventional therapy of taper pathological changes, described support under expansion state, the external diameter of described support proximal part with
The external diameter of described support distal end is different;And in the case of majority pathological changes, outside described support proximal part
Footpath is more than the external diameter of described support distal end.
In order to adapt to the interventional therapy of taper pathological changes shown in Fig. 1, described support under expansion state,
Its external diameter is gradually reduced to the distal end of described support by the proximal part of described support, and forms circular platform type
The conical support of structure.And described support is under expansion state, the external diameter (D) of described support proximal part
For 4.5cm, the external diameter (d) of described support distal end is 2cm;The external diameter ratio of described support proximal part
The big 2-3cm of external diameter of described support distal end.
Use the conical support of structure shown in Fig. 2 that target lesion two ends can be made adherent more preferably, far-end simultaneously
Vascular dissection will not be caused because stent diameter is excessive, rupture.Visible, the structure of this support is more
It is applicable to the pathological change form of case shown in Fig. 1.
Meanwhile, described coronary artery bracket is the biodegradable stent being made up of degradable biomaterial;Preferably institute
Stating degradable biomaterial is PLLA.Meanwhile, described rack surface bag has and carries anti-proliferative drugs
Polymer, described polymer is the mixing formed with PDLLA by the anti-proliferative drugs that mass ratio is 1:1
Thing.Described support PTCA or and STENTS, can degrade the most voluntarily, makes integrity and the function of blood vessel
Recovered to naturalness.
Coronary artery bracket of the present invention adapt to taper pathological change form focus on described support proximal part and
The difference of distal end external diameter, the cancellated slightly morphological differences that its cradle wall itself is formed is to Jie
Enter the impact inconspicuous for the treatment of.
For occasionally having the patient forming abnormity vascular morphology because of situations such as hemangioma, conventional post clinically
Shape support still can not solve its problem.Now it is contemplated that non-according to Patients with Vasculopathy form Design
The special-shaped support of rule.
As a example by supporting structure shown in Fig. 2, available 3D printing technique manufactures, concrete steps bag
Include:
According to Coronary Artery in patients radiography, use QCA technology to obtain the morphological data of lesion vessels, carry out individual
The bionical coronary artery bracket of propertyization designs: the overall shape after opening according to intravascular space diameter design intravascular stent
State, determines the concrete configuration of intravascular stent, topological structure and detailed design, generates intravascular stent 3D data.
And utilize delamination software that model carries out layered shaping, generate 3D print platform can individual-layer data;
Use based on when melt extruding process forming, select a diameter of thread PLLA material (a diameter of
1.2mm-3mm) or block PLLA material, frictional force drives shower nozzle, screw rod shower nozzle, gas are used
The dynamic smelting process shower nozzle such as shower nozzle, stylus direct write shower nozzle, by controlled for material extrusion, shower nozzle wire vent
Representative diameter is 50-300 μm, and specifically going out filament diameter can be according to normal according to this area of support performance requirement
Rule means and mode are adjusted.3D print platform completes whole under process software and control software control
The 3D of individual support prints.Can also material laser selective melting forming technology (SLM) or selective laser
Thermal sintering technique (SLS) is as 3D printing-forming technique.Now PLLA material is prepared as powder
Powder, general powder diameter scope is 20-150 μm.First SLS or SLM print platform is becoming
Lay a thin layer material powder (thickness is 0.05mm-0.2mm) on shape base plate, laser is soft in special control
According to each layer cross section data under part control, selectively powder bed is scanned, by laser scanning
Region, powder particle occur soften or fusing and bonding shaping, not by the powder of laser scanning still in
Fluffy, can be as support;After one layer machines, workbench declines one layer (thickness of setting)
Height, then carry out next layer paving powder and scanning until whole intravascular stent process;
After 3D printing technique print carriage molding, utilize traditional handicraft by anti-proliferative drugs (as according to dimension
Not department) coat rack surface, make rack surface bag have polymer (this carrying anti-proliferative drugs
Polymer is that medicine is mixed by 1:1 with PDLLA).The personalized bionical medicament elution of the present invention is utilized to prop up
Frame can preferably solve special-shaped stenotic lesion coronarius.
And utilize the method that 3D printing technique prepares biomimetic scaffolds, it is only necessary to according to the pathological structure of patient
And situation designs suitable supporting structure, said method can be used, only need to be according to art technology
The Conventional wisdom of personnel, the simple argument structure adjusting described support can realize different structure support
Printing prepare, clinical therapeutic efficacy is especially prominent.
Obviously, above-described embodiment is only for clearly demonstrating example, and not to embodiment party
The restriction of formula.For those of ordinary skill in the field, the most also may be used
To make other changes in different forms.Here without also all of embodiment being given
With exhaustive.And the obvious change thus extended out or variation are still in the guarantor of the invention
Protect among scope.