A kind of intravascular stent, its preparation method and applicationTechnical field
The invention belongs to medical instruments field, be specifically related to a kind of intravascular stent, its preparation method and application.
Background technology
Venous disease is most commonly seen in vascular surgery disease, especially deep vein thrombosis of lower extremity and lower limb great saphenous veinVaricose is the most common.And having in the reason that both diseases are formed is caused by iliac vein compression greatly.Iliac vein is subject toPressure syndrome (iliacveincompressionsyndrome, IVCS) means that iliac vein is oppressed by iliac artery, causes intracavity to glueEven, narrow or inaccessible, thus there is the syndrome of range of clinical symptom, also known as May Thurner, Cockett syndrome.Ilium is quietArteries and veins iliac vein incidence rate is 20%～34%.
Solving compression of vein to perform the operation in treatment, owing to needs enter abdomen operation, wound is relatively big, and patient is the most difficult alwaysTo accept, therefore the operation number of cases at China's report is less.Cause a lot of patient's lower extremity swelling and distension to solve, have some patients because ofThe blood stasis of blood is stagnant there is phlebothrombosis.From the development of eighties of last century the nineties interventional technique, domestic begin through balloon expandable,The method of frame implantation solves iliac vein compression, and through the clinical treatment of nearly 20 years, the method for interventional therapy was vascular surgeryBoundary is accepted, simultaneously because wound is little, patient also can accept, and the most domestic have a lot of hospital to carry out this work.SimultaneouslyAlso have a lot of doctors that this technology is used for the patient of iliac vein thrombosis sequela.Along with being significantly increased of clinical disease number of cases,And clinic uses the arterial bracket that bore is bigger to treat the patient of detection of iliac vein compression syndrome at present always, thus occur in that oneIndividual important problem, i.e. in support, the probability of secondary thrombus is higher, and this is little with arterial bracket mesh, and the structure of iliac vein is ledCause arterial bracket and must stretch into postcava 1-1.5 centimetre, and its support force does not causes designed by vein.
At present, the research report of lot of domestic and foreign shows, the support designed with detection of iliac vein compression syndrome as indicationLess.Domestic self-inflated bone vein support (utility model: 201520126120.6) that can be taken off effectively prevents deep veins of lower limbThe pulmonary infarction that thrombus breaks loose causes, after completing therapeutic purposes, can take out through jugular vein or femoral vein approach and avoid support long-termIndwelling produces complication.For treating the narrow support of iliac vein (utility model: 201320053442.3) by nickel-titanium metal silkThe latticed webmaster that braiding is coiled into, webmaster front tube actinal surface is inclined-plane, and inclined-plane is 40 degree with the angle of webmaster section, and webmaster hasOval labelling circle, it is achieved accurate positioning.But these bone vein supports yet suffer from some problems: be not all suitable for recoveringBone venous blood flow state and increase blood flow, and it is easily caused the formation of thrombosis, thus be necessary to carry out novel bone venous branchThe research and development of frame and applied research.
Summary of the invention
The technical problem to be solved is to overcome the deficiencies in the prior art, it is provided that the blood vessel that a kind of structure is different props upFrame, its preparation method and application, this intravascular stent has and is not easily formed thrombosis, and histocompatibility is good, the support force to veinSuitably and not affect blood flow, simple in construction, easy to operate, accurate positioning, it is possible to meet the needs to iliac vein treatment in clinic.
For solving above technical problem, the present invention adopts the following technical scheme that
It is an object of the present invention to provide a kind of intravascular stent, it can become from the compressive state with the first cross-sectional diameterChange the expansion state to the second cross-sectional diameter having had extended,
Described intravascular stent is included on the axis direction of described intravascular stent the location section being connected and supports section,
Described location section includes circumferentially distributed multiple first repeated monomers along described intravascular stent,
The described section that supports is included on the axis direction of described intravascular stent at least two support unit adjoined one anotherConnecting unit with at least one, described support unit includes circumferentially distributed multiple second weights along described intravascular stentMultiple monomer,
The number of the first described repeated monomer is different from the number of the second described repeated monomer, is positioned at described support sectionBefore and after two ends described support unit in the second repeated monomer by described first connection unit and adjacent anotherThe second repeated monomer in individual described support unit connects one to one to constitute closed-loop structure.
According to an embodiment of the invention, the number of the first described repeated monomer is single less than the second described repetitionThe number of body.
Preferably, the number of the second described repeated monomer is 2 ~ 4 times of the number of the first described repeated monomer, describedThe number of the first repeated monomer be 4 to 10.
Further, the described leading section supporting section connects the first developing cell.
According to a preferred aspect of the present invention, the leading section of described the second repeated monomer supporting section connects theOne developing cell, the number of the first developing cell can equal can not also wait with the number of the first described repeated monomer.
In the present invention, the first repeated monomer can be connected with the second repeated monomer, it is also possible to is connected with being connected unit.
According to an embodiment of the invention, the bearing of trend of described location section and the axle of described intravascular stentThe angle in line direction is 0 ° ~ 60 °.
Preferably, it is 0 ° when the bearing of trend of described location section with the angle of the axis direction of described intravascular stentTime, described intravascular stent is substantially in cylinder；Bearing of trend and the axle of described intravascular stent when described location sectionWhen line direction has angle, described location section is from the one end being connected with described support section towards leading section graduallyDirection away from the axis of described intravascular stent extends.
According to a preferred aspect of the present invention, the leading section of the first described repeated monomer is fillet, the circular arc of filletInternal diameter radius is more than or equal to 0.1mm.
According to a preferred aspect of the present invention, a length of 5 ~ 15mm of the first described repeated monomer, preferably 10 ~15mm；The described a length of 40 ~ 140mm, preferably 60 ~ 120mm that support section；The thickness of described intravascular stent is 0.1 ~0.3mm。
According to an embodiment of the invention, a length of 1 ~ 7mm of the second described repeated monomer, preferably 2 ~ 5mm.
Preferably, the described rearward end supporting section connects multiple second developing cell.It is further preferable that it is describedThe number of the second developing cell is 3 to 10.
According to a specific embodiment of the present invention, the described unit that connects includes the week along described intravascular stentTo multiple connectors of distribution, the number of described connector is not more than the number of the second described repeated monomer.
Specifically, be positioned at described support before and after section the number of the described connector connected in unit at two ends withThe number of the second described repeated monomer is equal, is positioned at the described connection connected in unit at the described middle part supporting sectionThe number of body is less than the number of the second described repeated monomer.
Preferably, the width of described connector is 0.1 ~ 0.3mm.
In the present invention, the width of described connector is equal with the width of the first described repeated monomer.
In the present invention, the width of the second described repeated monomer can use regular width, such as 0.1 ~ 0.3mm.
According to a specific embodiment of the present invention, it is flat that the leading section of multiple the first described repeated monomers is formedFace and the axis perpendicular of described intravascular stent.
According to a specific embodiment of the present invention, it is flat that the leading section of multiple the first described repeated monomers is formedFace is 45 ° ~ 89 ° with the angle of the axis of described intravascular stent.
In the present invention, the material of described intravascular stent is rustless steel, memorial alloy, titanium alloy, tantalum alloy, the conjunction of cobalt chromiumOne or more in gold, biodegradable metals, biodegradable polymer, magnesium alloy, pure iron.
It is a further object to provide the preparation method of a kind of above-mentioned intravascular stent, by material according to support DesignPath on drawing carries out cut, then processes obtain described intravascular stent through pickling, electrochemical process.
Certainly, the intravascular stent of the present invention can also use additive method to be prepared, and such as, weaves or welds.
Third object of the present invention is to provide a kind of stent delivery system, and it includes above-mentioned intravascular stent.
Fourth object of the present invention is to provide a kind of above-mentioned intravascular stent purposes in bifurcated vessels.
Preferably, the present invention provides a kind of above-mentioned intravascular stent purposes in iliac vein.
The present invention is defined as the front of intravascular stent with side, section place, location, is defined as blood supporting side, section placeThe rear of pipe holder.
Angle defined in the present invention is the angle less than 90 ° formed between straight line and plane or straight line and straight line.
The total length of the intravascular stent in the present invention refers to that the leading section of the first repeated monomer is to the second developing cellLong vertical dimension.The length of the first repeated monomer and the second repeated monomer refers to that the leading section of each repeated monomer is to rearward endVertical dimension.The length supporting section refers to the vertical dimension between the first developing cell to the second developing cell.
Due to the enforcement of technique scheme, the present invention compared with prior art has the advantage that
The intravascular stent of the present invention is particularly well-suited to iliac vein, good to the support effect of iliac vein, and the injury to wall of vein is little,Can be prevented effectively from intravascular stent and implant the formation of secondary thrombus in after-poppet, the present invention is by closing the formation of supports section two endsRing structure, middle employing open loop structure, it is possible to well improve the support at two ends after the support force at two ends, beneficially support dischargeUniformity and expansion uniformity, thus reduce the damage to blood vessel wall.Additionally, the intravascular stent of the present invention can be good atIliac vein positions, improves the accuracy of release, easy and simple to handle, the simple in construction of the intravascular stent of the present invention, produceConvenient, low cost, thus have important practical significance and good potential applicability in clinical practice.
Accompanying drawing explanation
Fig. 1 is schematic diagram (bearing of trend of location section and the blood vessel that the intravascular stent of embodiment 1 is implanted in iliac veinThe axis direction of support is consistent)；
Fig. 2 is the structural representation that the intravascular stent of embodiment 1 is launched into plane；
Fig. 3 is the intravascular stent axonometric chart (bearing of trend of location section and the axle of intravascular stent at expansion state of embodiment 1Line direction is consistent)；
Fig. 4 is the intravascular stent axonometric chart (location section is horn mouth shape) at expansion state of embodiment 1；
Fig. 5 is the enlarged drawing of the first connector；
Fig. 6 is the enlarged drawing of the first repeated monomer；
Fig. 7 is the structural representation that the intravascular stent of embodiment 2 is launched into plane；
Fig. 8 is the intravascular stent axonometric chart (bearing of trend of location section and the axle of intravascular stent at expansion state of embodiment 2Line direction is consistent)；
Fig. 9 is the intravascular stent axonometric chart (location section is horn mouth shape) at expansion state of embodiment 2；
Figure 10 is the schematic diagram (location section is horn mouth shape) that the intravascular stent of embodiment 1 is implanted in iliac vein；
Figure 11 is that (bearing of trend of location section props up the schematic diagram that is implanted in iliac vein of the intravascular stent of embodiment 2 with blood vesselThe axis direction of frame is consistent)；
Figure 12 is the schematic diagram (location section is horn mouth shape) that the intravascular stent of embodiment 2 is implanted in iliac vein；
Wherein: 1, location section；11, the first repeated monomer；2, central support section；21, support unit；211, second repeats listBody；22, unit is connected；221, connector；4, the first developing cell；5, the second developing cell；β is the front end of the first repeated monomerThe angle of the axis of the plane that portion is formed and intravascular stent；W1 is the width of connector；W3 is the width of the first repeated monomer；W4 is the width of the second repeated monomer；L1 is the length of the first repeated monomer；L2 is the length supporting section；L4 is the second repetitionThe length of monomer；L6 is the intravascular stent total length when expansion state.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention will be further described in detail, but the present invention is not limited to following enforcementExample.
The intravascular stent of the present invention is primarily adapted for use in bifurcated vessels, is particularly well-suited in iliac vein (such as Fig. 1).By bloodDuring iliac vein implanted by pipe holder, intravascular stent is arranged in the carrier of stent delivery system, now, at intravascular stentIn compressive state, after intravascular stent is delivered to correct position by carrier, discharging intravascular stent, intravascular stent expands outwardly toExpansion state, thus iliac vein is played a supporting role, intravascular stent has the first cross section when compressive state, at expansion shapeThere is during state state the second cross section, and, the diameter of the first cross section is less than the diameter of the second cross section.In the present invention, theOne cross section and the second cross section are the cross section supporting section 2, and the axis perpendicular of this cross section and intravascular stent.This realityExecuting in example, the external diameter of the second cross section is 10 ~ 20mm, preferably 12 ~ 16mm.
The material of intravascular stent is rustless steel, memorial alloy, titanium alloy, tantalum alloy, cochrome, biodegradable goldOne or more in genus, biodegradable polymer, magnesium alloy, pure iron.Rustless steel can use SUS-316L rustless steel etc..NoteRecall alloy and can use Ni-Ti alloy, Cu-Al-Mn alloy etc..Cochrome can use CoCr-L605 cochrome etc..Biology canDegraded metal is a kind of metal that can decompose in human body, the purest magnesium, magnesium alloy, pure iron and ferroalloy etc..BiodegradablePolymer can be polylactic acid, polyglycolic acid, poly-(lactic acid-6-caprolactone), the biodegradable such as poly-(glycolic-6-caprolactone)Polymer.In addition, it is possible in vivo in degradable metal, coat a kind of biodegradable polymer material to be used as blood vessel and prop upThe material of frame.
The intravascular stent of the present invention can utilize laser engraving one-shot forming.The production process of laser engraving: first, based onSupport Design drawing utilizes CAM to create cutting path；Secondly, metal or macromolecular material are carried out cut；Finally, pass throughPickling and electrochemical process improve surface smoothness, make each edge shape mellow and full.
As shown in Figures 2 and 3, intravascular stent is included in the positioning area connected from front to back on the axis direction of intravascular stentSection 1 and support section 2.
Location section 1 includes circumferentially distributed multiple first repeated monomers 11 along intravascular stent.
Support section 2 and be included at least two support unit 21 adjoined one another on the axis direction of intravascular stent and at leastOne connects unit 22, and support unit 21 includes circumferentially distributed multiple second repeated monomers 211 along intravascular stent, connectsUnit 22 includes the circumferentially distributed multiple connectors 221 along intravascular stent, and the number of connector 221 is not more than the second repetitionThe number of monomer 211.It is positioned at the second repeated monomer 211 supported before and after section 2 in the support unit 21 at two ends by firstConnect the connector 221 in unit 22 with the second repeated monomer 211 one_to_one corresponding in another adjacent support unit 21 evenConnect to constitute closed-loop structure, therefore, be positioned at and support the number of the connector 221 connected in unit 22 at two ends before and after section 2Equal with the number of the second repeated monomer 211, be positioned at the middle part supporting section 2 the connector 221 connected in unit 22Number is less than the number of the second repeated monomer 211, it is preferable that the number of the second repeated monomer 211 in each support unit 21 is2 ~ 3 times of connector 221 number in each connection unit 22.Therefore, the support unit at the middle part supporting section 2 it is positioned at for openingRing structure.
The first repeated monomer 11 in the present invention and the structure of the second repeated monomer 211 can be can form hole anyShape, such as V-type, grid type, rhombus etc..The connector 221 distribution mode on whole intravascular stent can be arbitrary, exampleSuch as form of straight lines, V-type, W type, S type, N-type etc..
In the present invention, the leading section connection supporting section 2 has the first developing cell 4, in the present embodiment, supports section 2The leading section of the second repeated monomer 211 connects has the first developing cell 4, the setting of the first developing cell 4 to make intravascular stent energyEnough well realization positions, and facilitates doctor to find point of release accurately.
In the present embodiment, the rearward end of the first repeated monomer 11 is connected with the leading section of the second repeated monomer 211.
In the present invention, the number of the first repeated monomer 11 is 4 to 10, and the number of the first developing cell 4 repeats with firstThe number of monomer 11 is equal or different.
In the present invention, the rearward end connection supporting section 2 has multiple second developing cell 5, the number of the second developing cell 5It is 3 to 10, and, the number of the second developing cell 5 is equal with the number of the first developing cell 4.In the present embodiment, second showsShadow unit 5 can be connected with support unit 21, or is connected with being connected unit 22, and the second developing cell 5 props up along blood vesselThe circumference of frame is uniformly distributed.
In the present invention, the number of the first repeated monomer 11 is different from the number of the second repeated monomer 211.Preferably, firstThe number of repeated monomer 11 is less than the number of the second repeated monomer 211, and in the present embodiment, the number of the second repeated monomer 211 is2 ~ 4 times of the number of the first repeated monomer 11, thus ensure that the aperture that the first repeated monomer 11 is formed is relatively big, as shown in Figure 1 willAfter intravascular stent implants iliac vein, when location section 1 extends postcava, it is possible to avoid because the aperture of intravascular stent is less to leadingThe formation of hyperamization bolt and avoid positioning section 1 blood flow of opposite iliac vein is impacted.
In the present embodiment, the bearing of trend of location section 1 is 0 ° ~ 45 ° with the angle of the axis direction of intravascular stent.Such as figureShown in 3, the bearing of trend of location section 1 is consistent with the axis direction of intravascular stent, i.e. angle is 0 °, and now, intravascular stent existsSubstantially in cylinder type during expansion state.As shown in Figure 4, the bearing of trend of location section 1 is deposited with the axis direction of intravascular stentAt angle, and, location section 1 gradually props up away from blood vessel towards leading section from the one end being connected with support section 2The direction of the axis of frame extends, i.e. location section 1 is in the horn mouth shape the most gradually expanded outwardly.
In the present embodiment, the width W1(of connector 221 is as shown in Figure 5) it is 0.1 ~ 0.3mm.The width W1 of connector 221With the width W3(of the first repeated monomer 11 as shown in Figure 6) equal.The width W4(of the second repeated monomer 211 is as shown in Figure 5) canTo use regular width, such as 0.1 ~ 0.3mm.
In the present embodiment, the thickness 0.1 ~ 0.3mm(of intravascular stent is not shown), the thickness of intravascular stent refers to that blood vessel props upThe external diameter of the cross section of frame and the difference of internal diameter.
In the present embodiment, the leading section of the first repeated monomer 11 is fillet, and the circular arc internal diameter radius of fillet is more than 0.1mm(not shown), thus decrease the intravascular stent stimulation to blood vessel.
In the present embodiment, length L1 of the first repeated monomer 11 is 5 ~ 15mm, preferably 10 ~ 15mm, the first repeated monomerThe length of 11 is long, and the leading section of the first repeated monomer 11 can be caused to touch the blood vessel wall on opposite and cause the stimulation to blood vesselEtc. adverse effect；The length of the first repeated monomer 11 is too short, then can affect intravascular stent location in iliac vein so that blood vesselSupport cannot stably be implanted in desired location.
Length L2 supporting section 2 is 40 ~ 140mm, preferably 60 ~ 120mm, and length L4 of the second repeated monomer 211 is 1~ 7mm, preferably 2 ~ 5mm.That is, supporting section 2 and generally comprise 16 support units 21, certainly, the number of support unit 21 also may be usedTo be adjusted according to actual needs.
The intravascular stent of the present invention total length L 6 when expansion state is 50 ~ 120mm, preferably 60 ~ 100mm.
Embodiment 1 is identical with the foregoing of embodiment 2, difference only with: in embodiment 1, multiple first repeated monomersThe plane that the leading section of 11 is formed and the axis perpendicular of intravascular stent, as shown in Figures 2 and 3.In embodiment 2, Duo GeThe plane that the leading section of one repeated monomer 11 is formed and the axes intersect of intravascular stent, and multiple first repeated monomer 11The plane that leading section is formed is 45 ° ~ 89 ° with the angle β of the axis of intravascular stent, as shown in Figs. 7-9, wherein, and Fig. 7 to 9In, the plane that the leading section of multiple first repeated monomers 11 is formed is 70 ° with the angle β of the axis of intravascular stent, embodiment 2In, the length of the first repeated monomer 11 gradually changes, but, its length range should be at the first repeated monomer of above-mentioned restrictionWithin the length range of 11.
Above the present invention is described in detail, its object is to allow the personage being familiar with this art will appreciate that thisInvention content and be carried out, can not limit the scope of the invention with this, and the invention is not restricted to above-mentioned enforcementExample, all equivalence changes made according to the spirit of the present invention or modification, all should contain within protection scope of the present invention.