Background technique
In vascular lesion Minimally Invasive Surgery, intravascular stent is sent into lesion locations by transportation system and is discharged.It is propped up during transportingFrame follows transportation system that may undergo the angiosomes such as bending, narrow, calcification or erosion, and bracket need to closely be tied with transportation systemIt closes, must not fall off during transport, otherwise can cause blood vessel blockage, bring life danger to patient.
Transportation system and bracket binding site are generally sacculus, and bracket is bonded in such a way that pressure is held with sacculus.To reduceFall off risk, and there are many designs for sacculus to change or fastness of the reinforced support in conjunction with sacculus at present.
Application No. is 201210350041.4 Chinese patent applications, provide a kind of sacculus of " double-shaft shoulder " structure, lead toMold transformation is crossed, sacculus end is made into bulge-structure, movement of the limit bracket on sacculus, to improve bracket fastness.This method needs to be transformed existing mold, and sacculus molding technology is complicated.To make " both shoulders " effectively, completion is held in routinely pressureAfterwards, heating pressurization and cooling treatment are added, process is complicated, and needs to carry out temperature control in the process, may be to part high scoreSub- stock support is not applicable.
Application No. is 201310744505.4 Chinese patent applications, provide a kind of sacculus with lamination layer structure,The coefficient of friction for increasing outer layer balloon material achievees the effect that increase bracket fastness.Relatively conventional sacculus processing technology, it is double-deckSacculus processing technology is complicated.
Application No. is 201410289527.0 Chinese patent applications, provide a kind of sacculus that surface is modified, modifiedBalloon surface rustic is nanoscale, improves the frictional force between bracket and sacculus and then achievees the effect that anti-slip.The techniqueVacuum plant, ultraviolet radioactive and gas shield are needed, it is complicated for operation.
Application No. is 201320870596.1 Chinese patent applications, provide a kind of balloon surface processing unit, pass throughIon processing increases the surface roughness of sacculus, achievees the purpose that increase binding force between metallic support and sacculus.This method needsIt is equipped with ion processing room.
The design of the above several patents application is improvement of starting in terms of sacculus, so that the processing technology of sacculus becomes multipleIt is miscellaneous.
Application No. is 201010034532.9 Chinese patent applications, a kind of method that classification pressure is held are provided, to bracketRadial hot pressing stage by stage is carried out to reach bracket until bracket is bonded with sacculus and sacculus is bonded closer target, this method masterIt to be improved from the operation stage that pressure is held, but the technique reduces the efficiency that pressure is held.
Deficiency existing for method for the fastness of above-mentioned existing realization change or reinforced support in conjunction with sacculus, thisField technical staff always search for effective method be subject to it is perfect.
Summary of the invention
The purpose of the present invention is to provide the methods and medical device of the binding force of a kind of raising bracket and sacculus, to solveDeficiency existing for the method for the fastness of change or reinforced support in conjunction with sacculus in the prior art.
In order to solve the above technical problems, the present invention provides a kind of medical device, the medical device include: a sacculus andPressure is held on the bracket of the sacculus outer surface, and the bracket has the wave bar of composition wave ring and the connecting rod of connection adjacent wave ring,The wave bar includes at least first wave bar and the second wave bar, and the wall thickness of the first wave bar is greater than the wall thickness of the second wave bar.
Optionally, in the medical device, the first wave bar forms first wave ring, the second wave bar composition theTwo wave rings.
Optionally, in the medical device, the first wave ring and the second wave central spacer are arranged.
Optionally, in the medical device, the first wave ring is located at the proximal end and/or distal end of the bracket, instituteState the interlude that the second wave ring is located at the bracket.
Optionally, in the medical device, the difference of the wall thickness of the wall thickness of the first wave bar and the second wave barLess than or equal to 40 microns.
The present invention also provides a kind of method of the binding force of raising bracket and sacculus, the combination for improving bracket and sacculusThe method of power includes:
Bracket or tubing are provided, the tubing is prepared as bracket by cutting；
The inner surface of the bracket or the tubing is handled, to change the flatness of the inner surface of the bracket；Wherein, the method for changing the flatness of the inner surface of the bracket is the mode of stamp or the mode of machining.
Optionally, in the method for the described binding force for improving bracket and sacculus, to the bracket or the tubingInner surface is carried out processing by the way of stamp and included the following steps:
The stamp mandrel for providing an outer surface and having concaveconvex structure or relief fabric, is inserted into institute for the stamp mandrelThe inside of bracket or the tubing is stated, and the stamp mandrel and the inner wall of the bracket or the tubing is made to fit；
The stamp mandrel is heated, to soften the inner wall of the bracket or the tubing, stamp forms the stamp mandrelOuter surface shape.
Optionally, locating after the stamp mandrel heating in the method for the binding force for improving bracket and sacculusTemperature between the glass transition temperature and melting temperature for the material for preparing the tubing.
Optionally, in the method for the described binding force for improving bracket and sacculus, to the bracket or the tubingInner surface is carried out processing by the way of machining and included the following steps:
One grinding rod is provided, the grinding rod is inserted into the inside of the bracket or the tubing, and makes the grinding rodThe inner surface of the relatively described bracket or the tubing carries out spin finishing；
The grinding rod is adjusted in the position of the inside of the bracket or the tubing, and controls the grinding rod to describedThe inner surface of bracket or the tubing carries out the grinding radius of spin finishing, to control the different portions of the bracket or the tubingThe spin finishing thickness of position.
Optionally, in the method for the binding force for improving bracket and sacculus, the grinding rod has at through frostedThe outer surface of reason.
In a kind of method and medical device of the binding force for improving bracket and sacculus provided by the present invention, the medical treatmentDevice includes the bracket that a sacculus and pressure are held on the sacculus outer surface, and the bracket has wave bar and the connection of composition wave ringThe connecting rod of adjacent wave ring, the wave bar include at least first wave bar and the second wave bar, and the wall thickness of the first wave bar is greater than instituteState the wall thickness of the second wave bar.When bracket pressure is held in the outer surface of sacculus, the wave bar of different wall thickness forms the inner surface of bracketRugged face, and then increase sacculus and support and the mechanical resistance that is subject to when relative motion occurs, increase sacculus and bracket itBetween binding force, effectively reduce the risk being detached from bracket transmission process.
Specific embodiment
Make below in conjunction with method of the drawings and specific embodiments to the binding force of raising bracket proposed by the present invention and sacculusIt is further described.According to following explanation and claims, advantages and features of the invention will be become apparent from.It should be notedIt is that attached drawing is all made of very simplified form and using non-accurate ratio, only to facilitate, lucidly aid in illustrating this hairThe purpose of bright embodiment.
Herein, " proximal end " and " distal end " is from using doctor's angle of the medical instrument to carry out read fortune for mutual memberPart or the relative bearing of movement, relative position, direction, although it is restrictive, " proximal end " that " proximal end " and " distal end ", which is not,The Medical Devices are often referred in course of normal operation close to one end of doctor, and " distal end " typically refers to initially enter patient's bodyInterior one end.
Herein, "inner" or " inside " refer to that the direction of the axis close to bracket, "outside" or " outside " refer to far from branchThe direction of the axis of frame.
As used in the specification and the appended claims, singular "a", "an" and "the" includesPlural reference, in addition in addition non-content explicitly points out.As used in the specification and the appended claims, term "or"Usually carried out with including the meaning of "and/or" using, in addition in addition non-content explicitly points out.
Referring to FIG. 1, it is the flow chart for improving the method for binding force of bracket and sacculus.The raising bracket and sacculusThe method of binding force include:
S1: providing bracket or tubing, and the tubing is prepared as bracket by cutting；
S2: handling the inner surface of the bracket or the tubing, with change the bracket inner surface it is smoothDegree；Wherein, the method for changing the flatness of the inner surface of the bracket is the mode of stamp or the mode of machining.
Compared to, to change the process conditions of sacculus as point of penetration, the present invention looks for another way, with branch in existing methodFrame sets about improving as design object, and the main flatness by changing the inner surface of the bracket (shows as out-of-flatnessProcessing), the binding force of bracket and sacculus is improved to increase the mechanical resistance being subject to when sacculus and support generation relative motion, noIt is related to improving the processing technology of sacculus, method is simple and effective, significant effect.
In order to preferably understand the mode for carrying out out-of-flatness processing to the inner surface of the bracket or the tubing, below with twoA embodiment is described in detail.
<embodiment one>
Fig. 2 a and Fig. 2 b is please referred to, understands the inner surface to the bracket or the tubing by the way of stampThe process of reason, specifically comprises the following steps:
Stamp mandrel 2 of one outer surface with concaveconvex structure or relief fabric is provided, the stamp mandrel 2 is inserted into describedThe inside of bracket or the tubing 1, and the stamp mandrel 2 and the inner wall of the bracket or the tubing 1 is made to fit；In order toReduce influence to bracket performance after the inner surface stamp processing of bracket, using the outer surface of stamp mandrel 2 concaveconvex structure orRelief fabric is the round and smooth construction in edge.Such as by the outer surface pattern indention of stamp mandrel 2 after the round and smooth processing in edgeIt replaces with wavy, wherein when the outer surface pattern of stamp mandrel 2 is waveform, constitute multiple wavelets in waveformShape medium wave peak is identical or different at a distance from trough.
The stamp mandrel 2 is heated, to soften the inner wall of the bracket or the tubing 1, stamp forms the stamp coreThe shape of the outer surface of axis 2.Wherein, locating temperature is between the material for preparing the tubing after the stamp mandrel 2 heatsBetween glass transition temperature and melting temperature, so that the temperature of the stamp mandrel 2 after heating is enough to soften the bracket or instituteThe inner wall of tubing 1 is stated, supports stamp.
In addition, the process heated for stamp mandrel 2 is in addition to may be implemented to the inner surface configuration of bracket or tubing 1 moreChange, it can be with the support performance of lifting bracket.Its principle is: due to there is the tune to acid extraction in heating processSection, thus it is possible to vary the thermal history of pipe material, suitably increase temperature and time can make pipe material crystallization more perfect, thereforeThe support force of bracket is promoted.
In the present embodiment, stamp mandrel is heated by the way of heat transmitting, preferably into the stamp mandrel with cavityInjection add hot medium, the mode of the logical heat transfer of the temperature of medium successively pass to stamp mandrel and with the stamp mandrelThe bracket or tubing that outer surface fits.
In order to preferably understand embodiment one, understood below incorporated by reference to example 1.
Example 1: please referring to Fig. 2 a and Fig. 2 b, and tubing described in this example is obtained by polylactic acid extrusion-blown modling, the pipeThe outer diameter of material is 4.0mm, and the stamp mandrel 2 is preferably the curved surface sacculus of nylon material.Bracket or tubing 1 are socketed on unexpandedThe curved surface sacculus of state is outer (as shown in Figure 2 a), the filling heat-conductive liquid into the curved surface sacculus of unexpanded state, so that unexpandedThe curved surface balloon expandable of state is bonded with bracket or 1 inner wall of tubing, is heated to the heat-conducting liquid in curved surface sacculus, so that plusThe temperature of curved surface sacculus after heat is between material (being polylactic acid in this example) glass transition temperature and melting for preparing tubingBetween temperature, soften the inner wall of bracket or tubing 1, stamp forms the shape of the outer wall of curved surface sacculus (i.e. stamp mandrel 2) (such asShown in Fig. 2 b).
When relatively thin in view of the body wall of bracket or tubing 1, the heating of stamp mandrel 2 will affect the appearance of bracket or tubing 1The case where face form (i.e. deformation occurs for outer surface), please refer to Fig. 2 c, the present invention in executing the step of heating stamp mandrel 2,It is solved using in such a way that the outer surface of bracket or tubing 1 is socketed hard sleeve 3.
Referring to FIG. 3, Case-based Reasoning 1 carries out out-of-flatness treated bracket, when it, which is pressed, is held on sacculus, bracket andSacculus is in pressure and holds state, and at least partly sacculus is filled into waveform curved surface.In actual use, blood vessel or lesionOne power F forward or backward is applied to bracket, slides bracket with respect to sacculus, since pressure holds state bracketThe inner surface of 1a is rendered as non-smooth (showing as being a wavy surface in this example), is filled in pressure in waveform curved surface and holds state ballCapsule 4a applies opposite effect power f to bracket, so that bracket be effectively prevent to hold state sacculus 4b surface sliding from pressure.
<embodiment two>
The inner surface of the bracket or the tubing is handled by the way of machining referring to FIG. 4, understandingThe process of (showing as regulating and controlling the bending amplitude of the inner surface of the bracket or the tubing), specifically includes following stepIt is rapid:
One grinding rod is provided, the grinding rod is inserted into the inside of the bracket or the tubing 1, and makes the grinding rodThe inner surface of the relatively described bracket or the tubing 1 carries out spin finishing；Wherein, the cross section of the grinding rod is circle, instituteThe outer surface for stating grinding rod includes but is not limited in curved surface or in plane.The bracket or the tubing in order to further increaseThe roughness of 1 inner surface can select the grinding rod with frosted outer surface to carry out spin finishing.
The grinding rod is adjusted in the position of the inside of the bracket or the tubing 1, and controls the grinding rod to instituteThe grinding radius of the inner surface progress spin finishing of bracket or the tubing 1 is stated, to control the bracket or the tubing 1 notWith the spin finishing thickness at position.
In embodiment one and embodiment two, to avoid the out-of-flatness of 1 inner surface of bracket or tubing from handling the branch to bracketThe problem of support performance impacts, bracket is caused to be broken.Answering for bracket is avoided as far as possible in the position that the present invention carries out out-of-flatness adjustmentPosition (such as on joining place or connecting rod 20 of Fig. 6 medium wave bar 10 and connecting rod 20) where power centrostigma, that is, carry out smoothThe position of degree adjustment is the lesser place that meets with stresses after stent-expansion, 11 in the middle part of wave bar.In the middle part of wave bar shown in Fig. 611 refer to the expansion of 10 upper bracket of wave bar after meet with stresses lesser position.
In order to preferably understand embodiment one, understood below incorporated by reference to example 2.
Example 2: tubing described in this example is obtained by polylactic acid extrusion-blown modling, and the outer diameter of the tubing is 4.0mm, wallThickness is 150 μm, and it is that the pie turnery piece of 3mm is made by controlling the rotation path in the turnery piece center of circle that the grinding rod, which selects outer diameter,Fall different-thickness in the different location turnery of bracket or the inner surface of tubing 1 in turnery piece outer surface.As shown in figure 4, using mechanicalThe mode of processing handle before bracket or the inner surface 5 of tubing 1 be plane, treated by the way of machining bracket orThe inner surface 6 of tubing 1 is arc-shaped surface, and the target wall thickness mean value of tubing is 125 μm after machined processing, and tubing is mostThin and most thick wall difference is less than or equal to 40 μm, to avoid the support fluctuation for causing bracket.
Referring to FIG. 5, Case-based Reasoning 2 carries out out-of-flatness treated bracket, when it, which is pressed, is held on sacculus, bracket andSacculus is in pressure and holds state, and at least partly sacculus is filled into arc-shaped curved surface.In actual use, blood vessel or lesion pairBracket applies a power F forward or backward, slides bracket with respect to sacculus, since pressure holds state bracket 1bInner surface be rendered as non-smooth (arc-shaped curved surface is shown as in this example), be filled in waveform curved surface pressure and hold state sacculus 4bOpposite effect power f is applied to bracket, so that bracket be effectively prevent to hold state sacculus 4b surface sliding from pressure.Further, simultaneouslyFrosted processing can also be done to turnery piece turnery face, higher roughness is presented in the inner surface of bracket or tubing 1 after making turnery,State sacculus 4b is held with increase pressure and presses the frictional force f ' held between state bracket 1b, and the two is detached from difficulty and increases.
The present invention also provides a kind of medical device, the medical device includes that a sacculus and pressure are held on the sacculus appearanceThe contact surface of the bracket in face, the bracket and the sacculus is a uneven whole face.Since contact surface is uneven whole face, bracketAfter pressure is held on the sacculus outer surface, the outer surface of at least partly sacculus is filled in the inner surface of the bracket.Medical treatment dressSetting middle bracket and sacculus can closely be combined together, and effectively improve the performance of medical device.The bracket of the medical device canTo be fabricated by previously described tubing or previously described bracket preparation method.
Wherein, the quantity of the recess and protrusion that include for the inner surface of bracket without limitation, as long as bracket pressure is held on instituteAfter stating sacculus outer surface, the contact surface of the two is uneven whole face.The inner surface of the bracket may include several recessAnd/or several protrusions；As shown in figure 3, when the inner surface of the bracket includes several recess and several protrusions, the bracketInner surface be waveform curved surface, waveform curved surface is collectively formed in protrusion and the structural edge of groove.As shown in figure 5, when describedWhen the inner surface of bracket includes a recess, the wall thickness at the bracket both ends is thicker than the wall thickness of the bracket interlude.
The present invention also provides a kind of medical devices.As shown in fig. 6, the medical device includes that a sacculus 30 and pressure are held on instituteThe bracket 1 of sacculus outer surface is stated, which has the wave bar of composition wave ring 12 and the connecting rod of connection adjacent wave ring.Such as Fig. 7 instituteOscillography bar 10 is end to end to constitute wave ring, arranged in parallel between multiple wave rings, there is the connection of connecting rod 20 between adjacent wave ring.Fig. 7 illustrates only a kind of illustrative supporting structure.It should be understood that supporting structure of the invention is not limited to shape shown in Fig. 7Formula, and can there are many variation.For example, the substantially aligned state of Wave crest and wave trough can be between wave bar 10 as shown in Figure 7,It Wave crest and wave trough can be staggered each other.Connecting rod 20 can use straight profiled bat (as shown in Figure 7) and/or N-type bar.Wave bar 10 and connectionThe thickness of bar 20 may be the same or different.The link position that connecting rod 20 connects wave bar 10 can be by wave crest to trough,Or by wave crest to wave crest, or by least one of trough to trough etc..
Bracket provided by the present invention is at least made of two kinds of wave bars, and wherein the wall thickness of the first wave bar is thicker, and secondThe wall thickness of wave bar is relatively thin.When bracket pressure is held in the outer surface of sacculus, the wave bar of different wall thickness makes the inner surface of bracket form heightThe face of low injustice, and then increase the mechanical resistance being subject to when relative motion occurs between sacculus and bracket.What the present invention was previously mentionedThe wall thickness of first wave bar is greater than the wall thickness of the second wave bar, it may be possible to which the average wall thickness of first wave bar is greater than the mean wall of the second wave barThick situation, it is also possible to which the thickest of first wave bar is greater than the case where thickest of the second wave bar, it is also possible to be theThe minimum wall thickness (MINI W.) of one wave bar is greater than the case where minimum wall thickness (MINI W.) of the second wave bar.
In an advantageous embodiment, first wave bar constitutes first wave ring, and the second wave bar constitutes the second wave ring.FirstWave ring and the second wave central spacer arrange, and related be alternatively arranged refers between two first wave rings (or second wave ring) hereinThere are one or more second wave rings (or first wave ring).
In another preferred embodiment, first wave bar is located at the proximal end and/or distal end of bracket.
The difference of the wall thickness of the wall thickness of first wave bar and the second wave bar is less than or equal to 40 microns, and wall thickness herein is as aboveThe average wall thickness that can be wave bar or thickest or minimum wall thickness (MINI W.).
To sum up, in a kind of method and medical device of the binding force for improving bracket and sacculus provided by the present invention, instituteStating medical device includes the bracket that a sacculus and pressure are held on the sacculus outer surface, and the bracket has the wave bar of composition wave ringWith the connecting rod of connection adjacent wave ring, the wave bar includes at least first wave bar and the second wave bar, the wall thickness of the first wave barGreater than the wall thickness of the second wave bar.When bracket pressure is held in the outer surface of sacculus, the wave bar of different wall thickness makes the interior table of bracketFace forms rugged face, and then increases sacculus and support and the mechanical resistance being subject to when relative motion occurs, increase sacculus withBinding force between bracket effectively reduces the risk being detached from bracket transmission process.
The present invention improves in the method for the binding force of bracket and sacculus, mainly by the bracket or the tubingSurface is handled to change the flatness of the inner surface of the bracket, thus increase sacculus and support occur relative motion when byThe mechanical resistance arrived effectively reduces the risk being detached from bracket transmission process to increase binding force between the two.ThisOutside, compared to, to change the process conditions of sacculus as point of penetration, the present invention is using bracket as design object in existing methodCarry out the binding force between lifting bracket and sacculus, without changing the process conditions of sacculus, greatly reduces the complexity of processing technologyDegree.Furthermore it is possible to out-of-flatness processing be carried out to the inner surface of the bracket or the tubing according to demand, with reinforced support and ballThe binding force of capsule has universality.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention, this hairAny change, the modification that the those of ordinary skill in bright field does according to the disclosure above content, belong to the protection of claimsRange.