CN1210021A - Self expansive stand - Google Patents
Self expansive stand Download PDFInfo
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- CN1210021A CN1210021A CN 98102493 CN98102493A CN1210021A CN 1210021 A CN1210021 A CN 1210021A CN 98102493 CN98102493 CN 98102493 CN 98102493 A CN98102493 A CN 98102493A CN 1210021 A CN1210021 A CN 1210021A
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- netting twine
- carve
- stand
- support
- sinusoidal line
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Abstract
A tensile self-expanding supporter as medical apparatus, its manufacturing method, its electrolytic grinding method for polishing its surface and the formula of electrolyte are disclosed. The supporter made of Ni-Ti alloy has net structure where adjacent tubes are connected to form a fish-scale type of structure. The circular tubes are cut in advance to form stagged seams. After pulling it, a cylindrical netted supporter is formed. Its advantages are high reliability, simple manufacture and high rate of finished products.
Description
Title of the present invention is a self expansive stand, belongs to technical field of medical instruments.
Body vessels support (Vascular Stent) is a kind of utensil that is placed on system all kinds of tube chambers inside such as coronary artery and peripheral vessels and urinary system, digestion, reproduction, breathing, with it prevent the tube chamber adhesion, narrow, cave in or thromboembolism, to keep pipeline unimpeded.The interior urethroptasty (PTCA-Percutaneous transluminal coronary angioplasty) of percutaneous coronary that past adopts, promptly the conduit inlet tube stenosis of end dribbling capsule, the pressurization of inflating fills the expansion tube chamber of sacculus, and it is external that the sacculus of exitting then shrinks extraction.But this disposal effect is bad, and 1/3rd above patients' expansion place tissue is upheld in pipe, and obvious restenosis takes place in general 6 months, so just need repeat PTCA or bypass surgery.In addition, fatal problem is that PTCA can cause the pipeline acute occlusion.The concrete reason that brings out is a lot, broken lobe plug is long-pending such as organizing, the tube wall spasm is shunk, thrombosis at interval etc.Gianturco in 1986 and sigwart have developed support technology (Stenting), promptly support expansion place of narrow pipeline with the little scaffold of metal, prevent to cave in and unexpected the obstruction to retraction, to keep pipeline unimpeded, a series of supporting structure patents and document have been delivered in front and back, and are widely used in clinical.Wherein majority is a stainless steel stent, this class support is because expansion back resilience is big, in order to keep inner chamber to expand the back size, then require full sacculus overvoltage, this has any problem for wide cross section, big inner chamber clinical implementation, so, developed NiTi (Nitinol) shape memory alloy stent of self expandable at aorta, carotid artery, esophagus and prostate etc.Conclude the representational four class self expandable supports that NiTi (Nitinol) is made, list table 1 in.
The above-mentioned the 1. class helix class formation support is the various spiral-shaped interior of cylindrical, conical and the two combination comprising appearance profile, and general shape-memory properties is relevant with the ratio size of screw diameter with wire diameter.Shape memory is good during metal wire slim, but support stiffness deficiency own.General self-expanding enlarged-diameter must be followed axial huge retraction.Lead angle is very little simultaneously, and its trend is almost square with the axis, moves axially very difficult.Because pining down of these two kinds of factors, this class support are difficult to provide expection to support effect.The fine motion friction takes place through regular meeting in the 2. class netting structure stand between cross-wires, life-time service can cause patient vessel's interior wall tissue hypertrophy, this in addition support weaving complexity, difficult quality guarantee.3. the be closed circle as the key component that supports intracavity space in the class supporting structure.The Nitinol alloy itself defines circumference to be increased to greatest extent and has only 7%, and the respective diameters swell increment is also very little, is difficult to realistic requirement.The 4. said unit of class support can be the sine curve coil, also can be other annular unit, and the connection between the unit can be an inclined to one side rigidity or flexible partially.Be interspersed owing to connect tinsel, then cause circumferential support inhomogeneous; Be that structure itself is complex-shaped in addition, cut finished product rate is low excessively.
Table 1
In general, existing supporting structure is unreasonable, axial shrinkage is big, and slipping property is bigger in blood vessel, and reliability is not enough, the better performances that has but complex structure, the processing and manufacturing difficulty, therefore, we have invented self expansive stand, purpose is to solve the problem of above-mentioned existence, and has proposed the new technology of simple and direct preparation support.
The thin-walled Nitinol pipe with central axis (1) shown in Fig. 1 (a) is the initial condition of self expansive of the present invention, be characterized in that tube wall has with cut or with taking pictures corrosion or with the seam at the quarter of embarking on journey isometric section (2) of other method preparation, carve interval bridge (3) the width equalization that keeps between seam section end, carve metal wire in the ranks (4) the width equalization of seam section.Adjacent two row are carved seam section relative position and are interspersed, and carve seam section end part interval bridge (3) and all are in the mid point position that adjacent lines are carved the seam section.Carve seam section trend and tangentially become θ with circumference
0The angle, θ
0The angle is actual to be to carve the lead angle that the seam section is arranged row, and its value is θ
0=
0～89 ° of scopes.
Carve seam thin-wall circular tube two ends at above-mentioned band and impose axial tension, then form the support that draws in the net of Fig. 1 (b), stitch 2 the quarter among Fig. 1 (a) and drawn back and become the mesh (6) that draws in the net, metal wire originally (4) is drawn as the netting twine (5) of sinusoidal line shape.As the original lead angle θ that quarter, the seam section was moved towards
0=0 o'clock, then as shown in Figure 2, the relation between the height function y of its geometry and the girth coordinate position x was the sinusoidal line of rule shown in Fig. 3 (a), and its formula is
y=Asinx
A is the amplitude constant relevant with level of stretch in the formula, as lead angle θ
0≠ 0, draw in the net that diameter reduces in the process, axially pulling is set pulling than being S, and then the actual lead angle θ of sinusoidal line planar development the lowest point tangent line is expressed as follows:
tgθ=S
3/2·tgθ。And relation is shown in Fig. 3 (b) between the height function y of the sinusoidal line that tilts this moment and lead angle θ and the girth coordinate position x, and its formula is:
y=tgθ+Asinx
The structure of the hauling type support shown in Fig. 1 (b) and Fig. 2 (a) is the netted cylinder that is interconnected to constitute by the serial netting twine (5) of regular sinusoidal line or inclination sinusoidal line shape respectively.Above-mentioned junction is called connection and saves (7), and shown in Fig. 1 (b) and Fig. 2 (a), it is overlapped with next line sinusoidal line peak (9) in order by lastrow sinusoidal line paddy (8) forms, and is by original interval bridge (3) differentiation and next.The netting twine (5) that so-called herein overlap joint in order is meant serial sinusoidal line shape (or from top to bottom), delegation from bottom to top presses delegation's orderliness to carry out the eclipsed connection of non-cross section, and Fig. 1 (b) and Fig. 2 (a) all are that up sinusoidal line paddy (8) is pushed down at descending sinusoidal line peak (9) (b).This connected mode decision colleague netting twine is not on the cylinder, and be on the taper seat or the spiral circle conical surface on.The series netting twine is connected to form and is bordering on square, rhombus and parallel tetragonal mesh (6).
Be square through cut and the cross section of support netting twine (5) of drawing in the net through drawing.In order to remove the cutting burr and to make sharp-pointed square rib become fillet, adopt electro-lapping process.To draw in the net to be placed on certain electric and separate in the liquid, move back and forth up and down with respect to drawing in the net rack surface with circular negative electrode, polished effectively as the dual function of anodic support through electrobrightening and abrasive polishing, and remove burr and cusped edge.The negative electrode that moves back and forth up and down simultaneously, near support local surfaces moment, between the gap very little, electric current density is very big, the mechanical ablation of abrasive material is also remarkable, like this, special ledge will be subjected to preferential grinding, so electrolytic polishing polishing itself also has the effect of finishing contoured cradle.In order to study the polishing surfaces externally and internally respectively, can successively use mould fixed support surfaces externally and internally respectively twice.Prescription is learned in electrolytic polishing liquefaction
Perchloric acid: glacial acetic acid: methanol=10: 5: 85
Control polishing fluid temperature-40 ℃, glacial acetic acid is little ice pellets and separates out under this temperature, can be used as the abrasive material that flexible mechanical grinds.Abrasive material can not take place and block in local polishing, because the local current densities conference heats up, the little ice pellets of minority glacial acetic acid is met thermosolization, and the crystallization again of lowering the temperature after removing carries out electrolytic polishing as abrasive material smoothly.
The present invention draws in the net support and is made by marmem NiTi (Nitinol) material, has the function in the automatic expansion diameter of certain temperature range.But support must be in advance through memory " training "; So-called training is meant imitation cooling compression repeatedly and the intensification shape process of recovering and expanding, with the function that guarantees to give the good automatic expanse diameter of support.Fig. 2 (b) is three the mesh situations that mesh is crushed under compressive state in Fig. 2 (a) right side.
Shape memory expanded in diameter rate can reach 100%, and expansion back resilience is 0%.
Self expansive stand advantage of the present invention is to have the revolution symmetrical structure, and the even support of radial radiation can be provided; Support has the netting twine that is similar to fish scale, be convenient to like this send to smoothly, simultaneously itself be pressed into to organize and clash, can effectively prevent the reverse slippage of support, can guarantee the center rest position like this, install very conveniently again,, prevent that slippage has crucial meaning for the strong situation of similar aorta scouring force; The inner chamber that support provided in addition, just in time blood flow direct motion has reduced resistance of blood flow; Support is hard and soft moderate, clinical sending to rapidly, and the fillet structure of support can effectively avoid scraping injured tissue.In addition, the manufacture method of hauling type can be simplified manufacture process greatly, commonly prepare support with cut or photoetching corrosion, be strict with the degree of making up of laser beam central axis and the precision of axial feed, generally manufacturing experimently yield rate only is about 40%, and uses the pulling method of being invented to prepare support, when original pipe is processed the rotation and send to, mostly laser beam is simple repeating motion relatively, and the lathe adjustment is easy, and yield rate is very high, the short time can be above 95%.
Embodiment
Diameter 8mm, length 20mm carotid artery self expansive stand with the Nitinol manufacturing.The Nitinol material is the marmem that is made into two kinds of elements of NiTi, with nearly equal proportion.The shape memory function of this class alloy realizes that by the inner micro-unitary changes in crystal structure of alloy this structural change all belongs to the rule displacement of atom collective.Reversible transformation can be in time carried out in (temperature) control because be heated, so custom is called " thermoelasticity transformation ".Just as physical culture rehearsal group callisthenics, it is the same do compulsory exercise whole formation to be changed by each team member of division of labor requirement, and the action of the shape memory of part outward appearance also is that inner component units thermoelasticity changes synergetic resultant effect in addition.Structure during this marmem high temperature claims austenite (A), and low temperature structure claims martensite (M).It is that martensite transfor mation is austenitic temperature-rise period that support is sent in the body, and this process begins transition temperature A
s, claim A and change the temperature that is over
fThis example adopts the A of alloy
f=35-65 ℃, other parameter of this support is listed below:
The net barrel is thick: 0.20mm (0.008 ") expansion pattern: self expandable
The expansion resilience: 0% axially shortens: 10%
Tinsel footpath: 0.20mm (0.008 ") radiography degree: on the upper side medium
Bending rigidity: circle between 70 holes: 1.0
Plough decreases coefficient: 11 resistances to sliding: 6
The used former material Nitinol pipe diameter 11mm of present embodiment, wall thickness 0.20mm.Orientation is perpendicular to central axis, lead angle θ
0=0 cuts out six along circumference with laser carves the seam section, carves seam segment length 5.3mm, and adjacent quarter, seam section circumferential position was staggered, bridge location is put aim at adjacent row to carve a seam section mid point.Carve the wide 0.20mm of metal wire between the seam section arrangement row.Conveniently take many pack supports of connecting in order to draw in the net clamping, one-off drawing segmentation then cuts.Draw ratio S=1.173 carries out temperature and draws or repeatedly protect the atmosphere bright annealing, and work hardening is middle breaks to avoid.Adopt electrobrightening to grind and remove flash cusped edge, finishing profile, polished surface, the polishing fluid prescription as mentioned above.Notice that support is kept inside information from outsiders in order to keep uniform polish, gradation clamping, polishing respectively.Utilize the surface tension of water to wipe the yellow complex mucosa that polishing is left on the support netting twine off.Finishing light support is made surperficial compatible decoration with silica gel then.Fig. 4 illustrates support clinical manipulation process, and it is outstanding in thing (11) that carotid wall (10) exists the sclerosis of medicated porridge shape, causes inner chamber narrow.It is different with percutaneous coronary urethroptasty (PTCA) to send support to, not by the balloon expandable inner chamber, only utilize little expansion sacculus (12) to fix to draw in the net self expandable support (13) herein, heat up too early for avoiding sending in the body, through conduit (4) input cooling normal saline solution, inject sacculus from transfusion circular hole (15).Send to and utilize seal wire (16) guiding to advance, notice that the control backing temp is lower than 20 ℃.Change the heating normal saline solution after arriving patient part, the control temperature is between 25～65 ℃, and this moment, shape memory alloy stent opened after heating up at once, supports outstandingly to form middle unobstructed inner chamber from thing.Because support utilizes shape memory function to expand automatically, so there is not expansion back resilience problem, clinical effectiveness is good.
Description of drawings
Fig. 1: the pipe with seam that stretches prepares support sketch map (a) pipe with seam (b) and draws in the net support
Fig. 2: drawing in the net support compressive state mesh changes (a) user mode support (b) compressive state support
Fig. 3: two kinds of netting twine geometrical curve contrast (a) regular sinusoidal curve (b) inclination sine curves
Fig. 4: support is sent sketch map to
1 central axis, 9 string of a musical instrument peaks
3 interval bridges 11 are outstanding in thing
4 metal wires, 12 sacculus
5 netting twines, 13 supports
6 meshes, 14 conduits
7 connect joint 15 transfusion circular holes
8 sinusoidal line paddy, 16 seal wires
The Chinese patents such as ginseng person's document 4,580,568 4/1986 Gianturco USP4665908 5/1 987 Jervis USP4795458 1/1989 Regan USP4984581 1/1991 Stice USP5037427 8/1991 Harada et al USP5067957 11/1991 Jevis USP5078604 1/1992 Yasuda USP5089005 2/1992 Harada USP5201901 4/1993 Harada et al USP5231989 8/1993 Middlemen et al USP5242451 9/1993 Harada et al USP5370683 6/1994 Arthur et al USP5466242 11/1995 Katsushi USP5562641 18/1996 Flomenblit et al USP9820497615 6/1998 Liu Wenxi
Claims (4)
1. one kind is equipped with the preparation method of self expansive stand with niti-shaped memorial alloy control, it is characterized in that:
(1) said niti-shaped memorial alloy pipe, be to be with series to embark on journey to carve seam section [2], carve the seam section and be with cut or with taking pictures etching or with stitching the isometric quarter that other method prepares, carve series interval bridge [3] the width equalization that keeps between the seam end, carve the seam section and arrange an interval bridge [3] that keeps between the row and all aim at the mid point that adjacent lines are carved the seam section, carve seam section trend and tangentially be angle theta on every side
0(θ
0=0～89 °)
(2) carve the niti-shaped memorial alloy pipe that stitches the coursing joint section along the said band of central axial direction [1] stretching and form self expansive stand, stitch section [2] and be drawn as mesh [6] quarter; Metal wire [4] is drawn as the netting twine [5] with regular sinusoidal line or inclination sinusoidal line shape, and bridge [3] becomes the connection joint [7] of netting twine at interval.
2. according to the said self expansive stand preparation method of claim 1, it is characterized in that:
(1) adopts the electrolytic polishing glossing
(2) electrolyte prescription is a perchloric acid: glacial acetic acid: methanol=10: 5: 85
(3) electrobrightening grinding work temperature is lower than-40 ℃
(4) ring cathode that pumps polishes grinding
3. self expansive stand that is equipped with niti-shaped memorial alloy control is characterized in that:
The netting twine of said serial sinusoidal line shape is interconnected to constitute netted cylinder, connecting joint [7] is overlapped in order by the sinusoidal line peak [9] of the sinusoidal line paddy [8] of netting twine and adjacent netting twine and forms, said orderly overlap joint be meant serial sinusoidal line shape netting twine from top to bottom or from bottom to top, delegation presses delegation regularly to carry out the eclipsed connection of non-cross section, single netting twine, be not on the face of cylinder, and be on the taper seat or the spiral circle conical surface.
4. according to the said self expansive stand of claim 3, it is characterized in that:
(1) forms by having mesh same squarish or rhombohedral or parallelogram [6]
(2) surface has the net line structure that is similar to cataphracted unidirectional inclination, order overlap joint
(3) has function the 25-65 ℃ of automatic expansion diameter of temperature range.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 98102493 CN1210021A (en) | 1998-07-02 | 1998-07-02 | Self expansive stand |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 98102493 CN1210021A (en) | 1998-07-02 | 1998-07-02 | Self expansive stand |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1210021A true CN1210021A (en) | 1999-03-10 |
Family
ID=5217377
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 98102493 Pending CN1210021A (en) | 1998-07-02 | 1998-07-02 | Self expansive stand |
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|---|---|
| CN (1) | CN1210021A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101484093B (en) * | 2006-06-01 | 2011-09-07 | 爱德华兹生命科学公司 | Prosthetic insert for improving heart valve function |
| CN105658183A (en) * | 2013-05-23 | 2016-06-08 | Sts医疗有限公司 | Shape change structure |
| CN107303209A (en) * | 2016-04-17 | 2017-10-31 | 郭红 | With the tubular intravascular stent that can be bent from circumference to slot |
| CN108796503A (en) * | 2018-06-12 | 2018-11-13 | 睿惢思工业科技（苏州）有限公司 | A kind of manufacture craft of speaker net |
| CN110814067A (en) * | 2019-11-14 | 2020-02-21 | 哈尔滨工业大学 | Follow-up induction heating assisted forming device and method for prefabricated vacant-position hollow pipe |
| US10912663B2 (en) | 2014-11-26 | 2021-02-09 | S.T.S. Medical Ltd. | Shape change structure for treatment of nasal conditions including sinusitis |
-
1998
- 1998-07-02 CN CN 98102493 patent/CN1210021A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101484093B (en) * | 2006-06-01 | 2011-09-07 | 爱德华兹生命科学公司 | Prosthetic insert for improving heart valve function |
| CN105658183A (en) * | 2013-05-23 | 2016-06-08 | Sts医疗有限公司 | Shape change structure |
| CN105658183B (en) * | 2013-05-23 | 2018-11-27 | Sts医疗有限公司 | Shape changes structure |
| US10953141B2 (en) | 2013-05-23 | 2021-03-23 | S.T.S. Medical Ltd. | Shape change structure |
| US10912663B2 (en) | 2014-11-26 | 2021-02-09 | S.T.S. Medical Ltd. | Shape change structure for treatment of nasal conditions including sinusitis |
| CN107303209A (en) * | 2016-04-17 | 2017-10-31 | 郭红 | With the tubular intravascular stent that can be bent from circumference to slot |
| CN107303209B (en) * | 2016-04-17 | 2019-05-24 | 郭红 | With circumference to slot can be with curved tubular intravascular stent |
| CN108796503A (en) * | 2018-06-12 | 2018-11-13 | 睿惢思工业科技（苏州）有限公司 | A kind of manufacture craft of speaker net |
| CN110814067A (en) * | 2019-11-14 | 2020-02-21 | 哈尔滨工业大学 | Follow-up induction heating assisted forming device and method for prefabricated vacant-position hollow pipe |
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